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| ChiCTR2000031199 | 6 April 2020 | A Medical Records Based Retrospective Study for Clinical Characteristics of severe Novel Coronavirus Pneumonia (COVID-19) | A Medical Records Based Retrospective Study for Clinical Characteristics of severe Novel Coronavirus Pneumonia (COVID-19) | | Xiangya Hospital, Central South University (West Campus of Wuhan Union Hospital) | 2020-03-23 | 20200323 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=51478 | Recruiting | No | 18 | 100 | Both | 2020-02-04 | Case series:120; | Observational study | Sequential | Retrospective study | China | Fan Rong | | 87 Xiangya Road, Kaifu District, Changsha, Hu'nan, China | fanrong3463@163.com | +86 13808454319 | Department of Integrated Traditional Chinese & Western Medicine, Xiangya Hospital, Central South University | Inclusion criteria: According to the clinical diagnostic criteria of the seventh or latest edition "diagnosis and treatment of pneumonia with novel coronavirus infection", severe COVID-19 pneumonia was clinically diagnosed. | Exclusion criteria: NO | Novel Coronavirus Pneumonia (COVID-19) | Case series:Nil; | Cure rate;improvement rate; | | | | No | False | | |
| → | EUCTR2020-000936-23-FR | 6 April 2020 | Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults - DisCoVeRy | Multi-centre, adaptive, randomized trial of the safety and efficacy of treatments of COVID-19 in hospitalized adults - DisCoVeRy | | INSERM | 09/03/2020 | 20200309 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-000936-23 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 09/03/2020 | 3100 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 4<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Spain;Belgium;France;United Kingdom;Germany;Netherlands;Luxembourg→Spain;United Kingdom;Germany;Netherlands;Luxembourg;Belgium;France | Christelle DELMAS | | 8 rue de la Croix Jarry | rqrc.siege@inserm.fr | 33182533368 | INSERM | Inclusion criteria: <br>1. Adult =18 years of age at time of enrolment.<br>2. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours prior to randomization.<br>3. Hospitalized patients with illness of any duration, and at least one of the following:<br>• Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air, <br>OR<br>• Requiring supplemental oxygen, high flow oxygen devices, non invasive ventilation and/or mechanical ventilation<br>4. Women of childbearing potential must agree to use at least one primary form of contraception for the duration of the study. Acceptable birth control methods are listed in section 7.3.<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 1700<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 1400<br> | Exclusion criteria: <br>1. Refusal to participate expressed by patient or legally authorized representative if they are present<br>2. Liver enzymes ALT/AST > 5 times the upper limit of normal.<br>3. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min)<br>4. Pregnancy or breast-feeding.<br>5. Anticipated transfer to another hospital, which is not a study site within 72 hours.<br>6. Patients treated with one of the antivirals evaluated in the study (i.e. remdesivir, interferon ß-1a, lopinavir/ritonavir, hydroxychloroquine) in the past 29 days<br>7. Contraindication to any study medication including allergy<br>8. Use of medications that are contraindicated with lopinavir/ritonavir i.e. drugs whose metabolism is highly dependent on the isoform CYP3A with narrow therapeutic range (e.g. amiodarone, colchicine, simvastatine)<br>9. Use of medications that are contraindicated with hydroxychloroquine: citalopram, escitalopram, hydroxyzine, domperidone, pipéraquine.<br>10. Human immunodeficiency virus infection under highly active antiretroviral therapy (HAART).<br>11. History of severe depression or attempted suicide or current suicidal ideation.<br><br><br> | COVID-19
- Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen < 72 hours prior to randomization.
- Illness of any duration, and at least one of the following:
•Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air, OR
•Requiring mechanical ventilation and/or supplemental oxygen.
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: MYLAN<br>Product Name: lopinavir/ritonavir<br>Pharmaceutical Form: <br>INN or Proposed INN: LOPINAVIR<br>CAS Number: 192725-17-0<br>INN or Proposed INN: RITONAVIR<br>CAS Number: 155213-67-5<br><br>Trade Name: REBIF<br>Pharmaceutical Form: <br><br>Trade Name: Remdesivir<br>Pharmaceutical Form: <br><br>Trade Name: Plaquenil<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: HYDROXYCHLOROQUINE<br>CAS Number: 118-42-3<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br><br> | Timepoint(s) of evaluation of this end point: Day 15;Primary end point(s): Clinical status of subject at day 15 (on a 7-point ordinal scale):<br>1. Not hospitalized, no limitations on activities<br>2. Not hospitalized, limitation on activities;<br>3. Hospitalized, not requiring supplemental oxygen;<br>4. Hospitalized, requiring supplemental oxygen;<br>5. Hospitalized, on non-invasive ventilation or high flow oxygen devices;<br>6. Hospitalized, on invasive mechanical ventilation or ECMO;<br>7. Death.<br><br>;Secondary Objective: Evaluate clinical efficacy of different investigational therapeutics as compared to the control arm as assessed by:<br><br>-Clinical Severity (Ordinal scale, National Early Warning Score (NEWS), Oxygenation, Mechanical Ventilation)<br>-Hospitalization : duration of hospitalization (days). <br>-Mortality<br>-Evaluate the safety of different investigational therapeutics through 28 days of follow-up as compared to the control arm<br>-Evaluate the virologic efficacy of different investigational therapeutics as compared to the control arm as assessed ;Main Objective: The overall objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the control arm in patients hospitalized with COVID-19.<br>• The primary endpoint is subject clinical status (on a 7-point ordinal scale) at day 15 <br> | | | | Yes | False | | |
| ACTRN12620000443998 | 14 April 2020 | Home rehabilitation for people with COVID-19: Implementing telehealth approaches to care | Home telerehabilitation for people with COVID-19: Implementing telehealth approaches to care and its effect on reintegration into the community | | Flinders Medical Centre | 06/04/2020 | 20200406 | ANZCTR | https://anzctr.org.au/ACTRN12620000443998.aspx | Not Recruiting | No | 18 Years | No limit | Both males and females | 01/05/2020 | 58 | Interventional | Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy; | Not Applicable | Australia | | | | | | | Inclusion criteria: Any person aged 18 or older, confirmed with COVID-19 referred to home rehabilitation services delivered at Flinders medical Centre through the division of rehabilitation, aged and palliative care. | Exclusion criteria: Prospective participants are excluded from the study if they decline the offer to participate in the study experimental arm. | COVID-19;Requiring home rehabilitation service; <br>COVID-19 <br>Requiring home rehabilitation service;Public Health - Health service research;Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation;Infection - Other infectious diseases | The primary aim of this study is to evaluate the efficacy and efficiency of two telerehabilitation interventions. The intervention consists of a rehabilitation intervention which focuses more on participation in usual activities and is offered via a coaching model to a virtual group of people. The intervention components are: identifying patient goals with therapist (1:1); and participation in virtual groups (up to 4 participants per session) with physiotherapist and occupational therapists which focus on increasing participation in life roles and usual activities. <br>The 1:1 session will last for approximately 45 minutes and will be followed by commencement of group sessions within 5 days.<br>Groups adopt a coaching model where the therapist talks about common challenges, facilitates discussion and sharing of experiences and ideas and the group brainstorm and plan next steps together. The group sessions will last approximately 45 minutes and will be delivered 3 times per week for up to 4 weeks. <br>Adherence will be measured using attendance logs. <br><br> | Integration to community as measured on the Reintegration to Normal Living Index (RNLI) - A 11-item questionnaire-based instrument that measures the degree to which individuals achieve reintegration into normal social activities (such as recreation, movement in the community, and interaction in family or other relationships). [Baseline, <br>Three (3) months following baseline assessment. ] | | | | Yes | False | | |
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| EUCTR2020-001492-33-FR | 14 April 2020 | Interest in the administration of Dornase alpha aerosol in Acute Respiratory Distress Syndrome secondary to respiratory infection by the coronavirus SRASCoV-2 / COVID-19 | Interest in the administration of Dornase alpha aerosol in ARDS secondary to respiratory infection by the coronavirus SRASCoV-2 / COVID-19 - COVID19-COVIDornase | | Hôpital Fondation Adolphe de Rothschild | 01/04/2020 | 20200401 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001492-33 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 10/04/2020 | 100 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: usual treatment<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| France | Clinical Research Director | | 29 rue Manin | pvachey@for.paris | 33148036433 | Hôpital Fondation Adolphe de Rothschild | Inclusion criteria: <br>- Major patient (age = 18 years old);<br>- Hospitalized in intensive care;<br>- Severe pneumonia COVID-19 with Berlin criteria for ARDS (PaO2/FiO2<300 and PEP>5).<br>- Intubated for less than 8 days ;<br>- Expected duration of mechanical ventilation is >48 hours;<br>- Carrying an arterial catheter;<br>- Affiliated with or beneficiary of a health insurance social protection scheme<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 50<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 50<br> | Exclusion criteria: <br>- Known hypersensitivity to Dornase alfa or any of the excipients;<br>- Pregnant or nursing woman;<br>- Patient with legal pro<br><br> | Patients on mechanical ventilation, inpatient resuscitation for ARDS, secondary to COVID-19 infection;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Pulmozyme 2500 U/2,5ml, solution pour inhalation par nébuliseur<br>Pharmaceutical Form: Inhalation solution<br><br> | Timepoint(s) of evaluation of this end point: D7;Primary end point(s): Comparison between the two treatment arms of the evolution of the PaO2/FiO2 ratio between D0 (inclusion) and D7;Secondary Objective: 1) all-cause mortality at D28<br>2) the clinical evolution at D28 ;<br>3) the duration of mechanical ventilation;<br>4) the number of days without mechanical ventilation at D28;<br>5) the length of stay in intensive care ;<br>6) the concentrations of blood markers of inflammation over time;<br>7) NET concentrations in bronchial secretions over time<br>8) the occurrence of adverse events;Main Objective: To evaluate the efficacy of intratracheal administration of dornase alfa (Pulmozyme) on the evolution of ventilatory parameters at D7 | | | | Yes | False | | |
| → | EUCTR2020-001194-69-ES | 14 April 2020 | Pilot study to evaluate the efficacy and safety of mefloquine as prophylaxis in people exposed to the disease caused by the new SARS-CoV-2 coronavirus (COVID-19) | Pilot study to evaluate the efficacy and safety of mefloquine as prophylaxis in people exposed to the disease caused by the SARS-CoV-2 coronavirus (COVID-19) - MEFLOCOVID-19 | | Félix Gutiérrez Rodero | 07/04/2020 | 20200407 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001194-69 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 30/03/2020 | 200 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Spain | Unidad de Enfermedades Infecciosas | | Camino de la Almazara 11 | gutierrez_fel@gva.es | 34966616234 | FISABIO | Inclusion criteria: <br>People in close contact with adults diagnosed with COVID-19 who sign the informed consent. Close contact is defined as those who live at home with an infected person, who have had intimate relationships or whose job is less than two meters from the infected person.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 100<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 100<br> | Exclusion criteria: <br>-Patients <18 years.<br>-Patients with symptoms suggestive of SARS-CoV-2 infection.<br>-Women who are pregnant or who intend to become pregnant for the next three months after taking the drug.<br>-Patients allergic to mefloquine or other quinine or quinidine-type medications.<br>-Patients with a neurological history (seizures, epilepsy, etc.).<br>-Patients with a previous history of psychiatric illnesses (depression, anxiety, suicide attempt).<br>-Patients with cardiac pathologies or relevant chronic diseases that in the judgment of the clinician recommend the non-inclusion of the patient in the study.<br>-Patients in treatment with other medications such as valproic acid, antiarrhythmics, antihistamines H1, beta-blockers, calcium channel blockers, chloroquine, halofantrine, phenothiazines, quinidine and quinine.<br> | COVID-19 infection is being spread around the world with more than 400.000 cases. The spred of the disease is being a world health problem.;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Lariam<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: MEFLOQUINE<br>CAS Number: 53230-10-7<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 250-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br> | Secondary Objective: -Establish if the preventive administration of mefloquine attenuates the clinical manifestations of COVID-19 in people who become infected.<br>-Evaluate the safety of prophylactic mefloquine in this setting.;Primary end point(s): COVID-19 infection.;Timepoint(s) of evaluation of this end point: The patient will be evaluated weekly for 30 days from enrollment in the study to rule out / confirm COVID-19 infection.;Main Objective: To determine the protective efficacy of mefloquine prophylaxis against placebo in close contacts of people with COVID-19.→Timepoint(s) of evaluation of this end point: The patient will be evaluated weekly for 30 days from enrollment in the study to rule out / confirm COVID-19 infection.;Primary end point(s): COVID-19 infection.;Secondary Objective: -Establish if the preventive administration of mefloquine attenuates the clinical manifestations of COVID-19 in people who become infected.<br>-Evaluate the safety of prophylactic mefloquine in this setting.;Main Objective: To determine the protective efficacy of mefloquine prophylaxis against placebo in close contacts of people with COVID-19. | | | | No | False | | |
| EUCTR2020-001565-37-ES | 14 April 2020 | Prevention of novel Coronavirus infection with hydroxychloroquine | PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE FOR HIGH-RISK HEALTHCARE WORKERS DURING THE COVID-19 PANDEMIC (PrEP_COVID): A UNICENTRIC, DOUBLE-BLINDED RANDOMIZED CONTROLLED TRIAL. - PrEP_COVID | | ISGlobal | 07/04/2020 | 20200407 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001565-37 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 03/04/2020 | 440 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Spain | Jose Muñoz Gutiérrez | | Calle Rosselló 132 4º2º | jose.munoz@isglobal.org | +349322754001825 | ISGlobal | Inclusion criteria: <br>- Age = 18 years<br>- Negative PCR and negative serology at day 0<br>- Healthcare worker at Hospital Clinic of Barcelona<br>- Female participants: negative for pregnancy test<br>- Willing to participate in the study<br>- Able to sign the informed consent form<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 435<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 5<br> | Exclusion criteria: <br>- Age <18 years<br>- Pregnancy or breastfeeding<br>- Ongoing antiviral or antiretroviral treatment or HIV positive<br>- Ongoing anti inflammatory treatment (NSAID, corticosteroids)<br>- Ongoing chloroquine or hydroxychloroquine treatment<br>- Confirmed case of SARS-CoV-2 infection (positive PCR) at day 0<br>- Positive serology for SARS-CoV-1 infection at day 0<br>- Impossibility of signing the informed consent form<br>- Rejection of participation<br>- Working less than 5 days a week in the Hospital Clinic of Barcelona.<br>- Any contraindication for hydroxychloroquine treatment (9):<br>o Hydroxychloroquine hypersensitivity or 4-aminoquinoline hypersensitivity<br>o Retinopathy, visual field or visual acuity disturbances<br>o QT prolongation, bradycardia (<50bpm), ventricular tachycardia, other arrhythmia, as determined on day 0 ECG or medical history<br>o Potassium < 3 mEq/L or AST or ALT > 5 upper normal limit, as determined on day 0 blood test<br>o Previous myocardial infarction<br>o Myasthenia gravis<br>o Psoriasis or porphyria<br>o Glomerular clearance < 10ml/min<br>o Previous history of severe hypoglycaemia<br>o Ongoing treatment with: antimalarials, antiarrhythmic, tricyclic antidepressants, natalizumab, quinolones, macrolides, agalsidase alfa and beta.<br> | COVID-19;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Dolquine<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Hydroxychloroquine Sulfate<br>CAS Number: 747-36-4<br>Other descriptive name: HYDROXYCHLOROQUINE SULFATE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: 6 months;Primary end point(s): Confirmed cases of a COVID-19 (defined by symptoms compatible with COVID-19 and/or a positive PCR for SARS-CoV-2) in the PrEP group compared to the placebo group at any time during the 6 months of the follow-up in healthcare workers with negative PCR for SARS-CoV-2 at day 0.;Secondary Objective: 1) To assess the efficacy of the use of PrEP with hydroxychloroquine against placebo in healthcare workers with high risk of SARS-CoV-2 infection in reducing their risk of exposure to SARS-CoV-2 (defined by seroconversion) during an epidemic period.<br><br>2) To evaluate the safety of PrEP with hydroxychloroquine in adults.<br><br>3) To describe the incidence of SARS-CoV-2 infection among healthcare workers at high risk of SARS-CoV-2 infection.<br><br>4) To identify clinical, analytical and microbiological predictors of COVID-19 among healthcare workers at high risk of SARS-CoV-2 infection.<br><br>5) To set up a repository (biobank) of serum samples obtained from healthcare workers at high risk of SARS-CoV-2 infection for future research on blood markers to predict SARS-CoV-2 infection.;Main Objective: To compare the efficacy of the use of PrEP with hydroxychloroquine against placebo in healthcare workers with high risk of SARS-CoV-2 infection in reducing their risk of COVID-19 disease during an epidemic period. | | | | No | False | | |
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| ACTRN12620000472976 | 20 April 2020 | Adapting the Decathlon Group Easybreathe® snorkelling face mask for the safer administration of oxygen and/or continuous positive airway pressure and in the intra/interhospital transportation of patients with proven or suspected COVID 19 infection. | Adapting the Decathlon Group Easybreathe® snorkelling face mask for the safer administration of oxygen and/or continuous positive airway pressure and in the intra/interhospital transportation of patients with proven or suspected COVID 19 infection. | | Dr Simon Joosten | 15/04/2020 | 20200415 | ANZCTR | https://anzctr.org.au/ACTRN12620000472976.aspx | Not Recruiting | No | 18 Years | No limit | Both males and females | 27/04/2020 | 100 | Interventional | Purpose: Treatment; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy; | Not Applicable | Australia | | | | | | | Inclusion criteria: Consecutive patients admitted to Monash Health with suspected or confirmed COVID-19 | Exclusion criteria: Patients shown to have proven COVID-19 swab negative. | COVID-19;Respiratory failure.;Safe inter- and intra- hospital transfer of patients suffering from suspected or confirmed COVID-19; <br>COVID-19 <br>Respiratory failure. <br>Safe inter- and intra- hospital transfer of patients suffering from suspected or confirmed COVID-19;Infection - Other infectious diseases;Respiratory - Other respiratory disorders / diseases | We are testing the feasibility and comfort of the use of a novel mask (the Decathlon group EasyBreathe snorkel mask) for the transport of patients between locations at our health service.<br>The Decathlon mask is a non-TGA approved device used for recreational snorkelling. It has been adapted for use in COVID-19 patients by Italian engineers (see https://www.isinnova.it/easy-covid19-eng/)<br>In this trial we propose to apply the Decathlon mask in place of standard delivery systems for oxygen and positive airway pressure. The Decathlon mask will be applied by clinicians in the hospital setting.<br>The mask is worn over the entire face and has advantages over conventional delivery methods in that it is thought to reduce the risk of virus aerosolization (a common problem with conventional delivery systems) and therefore increase safety for healthcare workers and other patients at the hospital.<br>We will test mask comfort and tolerability with daily questionnaires.<br>The mask will be applied to suspected or confirmed COVID-19 patients during transfer between the emergency department and other locations such as radiology department, ward and high dependency unit.<br>We anticipate the mask will be worn for several hours at a time depending on patient tolerability (early data from overseas suggests superior tolerability to conventional mask setups). The mask may be used intermittently for the entire patient admission to hospital pending the clinical needs and preference of the patient. We anticipate, based on how conventional treatments are applied, that the patient will use the mask in 3 hour sessions with potential breaks in between to be determined by clinical need and patient tolerability. | Patient comfort and tolerability as assessed by a 6 point question item originally developed for CPAP use. We will use a modified version of the 6 point scale developed by Balachandran et al JCSM 2013. It is a 6 point Likert scale.[At 24 hours after initiation of therapy and every subsequent 24 hours of use of the mask until disposition from hospital.] | | | | Yes | False | | |
| → | ACTRN12620000479909 | 20 April 2020 | Mental health and wellbeing on general population during the COVID-19 outbreak | Impact of Social Isolation on Mental Health during the COVID-19 Pandemic: a large international multi-centre cohort study | | The George Institute for Global Health | 16/04/2020 | 20200416 | ANZCTR | https://anzctr.org.au/ACTRN12620000479909.aspx | Not Recruiting | No | 18 Years | No limit | Both males and females | 01/05/2020 | 3000 | Observational | Purpose: Psychosocial;Duration: Cross-sectional;Timing: Prospective; | Not Applicable | Australia;China;United States of America;Italy;Germany;Spain | | | | | | | Inclusion criteria: All adults who live in China, Australia, United States of America, Germany, Italy and Spain that are affected by the COVID-19 outbreak, have experienced social isolation due to COVID-19 pandemic. They are willing to participate in the study and able to complete the online survey. | Exclusion criteria: • Patient < 18 years of age at the time of the study
<br> | Mental health;COVID19;Social isolation; <br>Mental health <br>COVID19 <br>Social isolation;Mental Health - Anxiety;Mental Health - Depression;Mental Health - Studies of normal psychology, cognitive function and behaviour;Public Health - Other public health | This is designed as a cross-sectional, community-based observational study assessing the impact of social isolation on mental health (depression, anxiety, insomnia) during the COVID-19 pandemic.<br>The duration of the study is one month.<br>The duration of observation in each participant will be single 15 min assessment | the prevalence of depression which will be assessed by the 9-item Patient Health Questionnaire[Assessed at baseline];the prevalence of anxiety, which will be assessed by the 7-item Generalized Anxiety Disorder scale[Assessed at baseline];the prevalence of insomnia, which will be assessed by the 7-item Insomnia Severity Index. [Assessed at baseline]→the prevalence of insomnia, which will be assessed by the 7-item Insomnia Severity Index. [Assessed at baseline];the prevalence of anxiety, which will be assessed by the 7-item Generalized Anxiety Disorder scale[Assessed at baseline];the prevalence of depression which will be assessed by the 9-item Patient Health Questionnaire[Assessed at baseline] | | | | Yes | False | | |
| ACTRN12620000480987 | 20 April 2020 | Stress-reduction Using Probiotics to Promote Ongoing Resilience Throughout COVID-19 for Healthcare Workers (SUPPORT COVID-19 Healthcare Workers) | Stress-reduction Using Probiotics to Promote Ongoing Resilience Throughout COVID-19 for Healthcare Workers: A randomised placebo-controlled trial | | University of Auckland | 16/04/2020 | 20200416 | ANZCTR | https://anzctr.org.au/ACTRN12620000480987.aspx | Not Recruiting | No | 18 Years | 70 Years | Both males and females | 01/06/2020 | 507 | Interventional | Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy; | Not Applicable | New Zealand | | | | | | | Inclusion criteria: Eligible participants are nurses working in a clinical area. | Exclusion criteria: 1. Already taking probiotic supplements
<br>2. Taking immune suppressant medication | Psychological Stress;COVID19; <br>Psychological Stress <br>COVID19;Mental Health - Studies of normal psychology, cognitive function and behaviour;Public Health - Health service research | Participants who are randomly assigned to the intervention group will receive capsules containing the probiotic Lactobacillus rhamnosus HN001 (6X109 colony forming units). <br><br>Participants will be instructed to take one capsule a day for a period of 12 weeks.<br><br>Adherence will be assessed by asking participants to enter the number of remaining capsules they have in the bottle at the post-intervention data collection phase. | Scores on the Perceived Stress Scale. The PSS is a widely used measure of the appraisal of how stressful events over the previous month are. Scores range from 0 to 40 with higher scores representing higher levels of stress. [Perceived Stress Scale scores will be measured at baseline and following a 12 week intervention period, with the primary time point of interest being scores post the 12 week intervention period.] | | | | Yes | False | | |
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| EUCTR2020-001290-74-ES | 20 April 2020 | Efficacy and safety of sarilumab in the early treament of hospitalized patients with mild-moderate neumonia and COVID19 infection versus standard of care | Efficacy and safety of sarilumab in the early treament of hospitalized patients with mild-moderate neumonia and COVID19 infection versus standard of care - SARICOVID | | Consorci Parc de Salut Mar (PSMAR) | 13/04/2020 | 20200413 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001290-74 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 11/04/2020 | 216 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Spain | Ana Aldea | | IMIM. Dr Aiguader | aaldea@imim.es | +34933160490 | Consorci PSMAR | Inclusion criteria: <br>- more than18 years<br>- diagnostic confirmation of COVID19 infection (PCR) and radiological diagnosis of pneumonia<br>- MEWS less than 3 and CURB 65 less than or equal to 1, IL6 greater than or equal to 20 pg / mL.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 180<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range 36<br> | Exclusion criteria: <br>- AST / ALT> 5 X LSN<br>- neutrophils <500 cell / mm3<br>- lymphocytes <400 cell<br>- Platelets <50,000 cell / mm3<br>- creatinine clearance (CCL) <30 mL / min<br>- Documented sepsis and active infection by other pathogens other than COVID-19<br>- presence of comorbidities that may lead to a poor prognosis according to clinical criteria<br>- Complicated diverticulitis or intestinal perforation<br>- Ongoing skin infection (eg uncontrolled pyodermitis with antibiotic treatment)<br>- anti rejection immunosuppressive therapy<br>- Other biological treatments<br>- At the investigator's discretion, survival less than 48 hours from screening<br>- Treatment with anti-IL 6, anti-IL-6R antagonists or with Janus kinase inhibitors (JAKi) in the last 30 days or plans to receive during the study period<br>- Current treatment with conventional synthetic disease modifying antirheumatic drugs (DMARDs) / immunosuppressive agents<br>- History of current systemic or localized autoimmune or inflammatory diseases, other than rheumatoid arthritis<br>- Known active tuberculosis (TB), history of incompletely treated TB, suspected or known extrapulmonary TB, suspected or known systemic bacterial or fungal infections<br>- Patients who have received immunosuppressive antibody therapy in the last 5 months, including intravenous immunoglobulin, or who plan to receive it during the study period.<br>- Participation in any clinical research study evaluating a research product or therapy (PI) within 3 months and less than 5 PI half-lives before the screening visit (The use of remdisivir in the context of a compassionate use remdisivir one-arm is allowed)<br>- Pregnancy<br>- hypersensitivity to Sarilumab and / or to some of its excipients.<br>- Any finding of the physical examination and / or history of any disease that, in the opinion of the study investigator, may confuse the study results or represent an additional risk for the patient due to their participation in the study.<br> | Patients with confirmed COVID-19 infection and criteria for mild-moderate pneumonia (CURB-65 =1 i SatO2 =90%, MEWS score less than 3) and IL6 values of 20 pg / ml, will be randomly assigned to a sarilumab treatment group or another group receiving treatment according to the current therapeutic protocol of the PSMAR. <br>MedDRA version: 21.1
Level: PT
Classification code 10035737
Term: Pneumonia viral
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Kevzara<br>Product Name: Kevzara<br>Product Code: 1171196003<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: SARILUMAB<br>Other descriptive name: EU/1/17/1196/012<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br><br>Trade Name: Azitromicina<br>Product Name: Azitromicina<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: AZITHROMYCIN DIHYDRATE<br>CAS Number: 83905-01-5<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 500-<br><br>Trade Name: hidroxicloroquina<br>Product Name: Hidroxicloroquina<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Hydroxychloroquine<br>CAS Number: 118-42-3<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br><br> | Main Objective: To assess the efficacy and safety of early treatment of sarilumab, added to standard treatment, in patients hospitalized for mild-moderate COVID-19 pneumonia, with criteria of a CURB 65 less than or equal to 1, oxygen saturation equal to or greater than 90%, MEWS less than 3 and with IL6 greater than 20 pg / mL.;Secondary Objective: To evaluate:<br>-Clinical status of patients on days 7 and 14 later than the treatment initiation.<br>-Proportion of patients discharged on day 14<br>-28-day mortality rate<br>-Proportion of patients who required mechanical ventilation and days of duration<br>-Days of hospital stay of patients who have survived to 28 days<br>-Time since start of treatment to death of the patient<br>-Possible serious adverse events related to sarilumab and possible causes of discontinuation of sarilumab treatment<br>to analyze:<br>-type of medications received during admission and days since onset of symptoms to starting glucocorticoids<br>-the evolution of prognostic factors: IL6, D-dimer, ferritin, calprotectin;Timepoint(s) of evaluation of this end point: 28 days;Primary end point(s): Time to clinical improvement, defined as the time from randomization to a two-point improvement (from randomization status) on an ordinal scale of seven categories or hospital discharge, whichever occurs first.<br><br>The seven-category ordinal scale consisted of the following categories: 1, not hospitalized with resumption of normal activities; 2, not hospitalized, but unable to resume normal activities; 3, hospitalized, not requiring supplemental oxygen; 4, hospitalized, requiring supplemental oxygen; 5, hospitalized, requiring nasal high-flow oxygen therapy, noninvasive mechanical ventilation, or both; 6, hospitalized, requiring ECMO, invasive mechanical ventilation, or both; and 7, death. | | | | No | False | | |
| → | EUCTR2020-001321-31-ES | 20 April 2020 | Clinical trial phase II to evaluate the efficacy of 3 types of treatment in patients with pneumonia by COVID-19 | Prospective, phase II, randomized, open-label, parallel group study to evaluate the efficacy of hydroxychloroquine together with baricitinib, imatinib or early lopinavir / ritonavir in patients with SARS Cov2 pneumonia (COVID-19 HUF) - COVID-19 HUF | | Hospital Universitario de Fuenlabrada | 13/04/2020 | 20200413 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001321-31 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 11/04/2020 | 165 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: No comparator
Number of treatment arms in the trial: 3
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | Comisión de Investigación | | Calle Camino del Molino 2 | fernando.bermejo@salud.madrid.org | 34916006000 | Hospital Universitario de Fuenlabrada | Inclusion criteria: <br>i. Signed informed consent form<br>ii. =18 years<br>iii. Confirmed diagnosis Pneumonia Covid19 +<br>iv. ECOG functional state 0 or 1<br>v. Less than 7 days from onset of symptoms<br>saw. NO contraindication for medication<br>vii. ECG QT <0.4<br>viii. Adequate liver, kidney and hematological function (or within the safety range to use these drugs)<br>1. Absolute granulocyte count> 1.5 x 109 / L<br>2. Absolute platelet count> 100 x 109 / L<br>3. Hb> 10 g / dL<br>4. Cr <1.5 mg / dL or Clearance> 50mL / min<br>5. Bilirubin <3 ULN<br>6. AST / ALT = 2.5 times ULN<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 80<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 85<br> | Exclusion criteria: <br>i. No Covid confirmation<br>ii. No pneumonia<br>iii. Previous treatment with any of the study drugs<br>iv. Concomitant serious medical condition<br>1. ICC<br>2. IAM 6 months prior<br>3. Unstable Angina<br>4. Cardiomyopathy<br>5. Unstable Ventricular Arrhythmia<br>6. uncontrolled HTA<br>7. Uncontrolled psychotic disorders<br>8. Serious active infections<br>9. HIV<br>10. Active hepatitis<br>11. Neoplasia in active cancer treatment<br>v. Inability to take oral medication or malabsorption syndrome<br>saw.<br>vi. Inability to comply with study and follow-up procedures<br>vii. History of only relevant thromboembolic or hemorrhagic episodes in the last 6 months<br>viii. Contraindication to any study medication<br>ix. Pregnant women<br> | Pneumonia due to SARS Cov2 (COVID-19);Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Dolquine<br>Pharmaceutical Form: Coated tablet<br>INN or Proposed INN: Dolquine<br>CAS Number: 747-36-4<br>Other descriptive name: HYDROXYCHLOROQUINE SULFATE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br><br>Trade Name: Kaletra versus Aluvia<br>Pharmaceutical Form: Coated tablet<br>INN or Proposed INN: RITONAVIR<br>CAS Number: 155213-67-5<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br>INN or Proposed INN: LOPINAVIR<br>CAS Number: 192725-17-0<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 50-<br><br>Trade Name: Imatinib<br>Pharmaceutical Form: Coated tablet<br>INN or Proposed INN: Imatinib<br>CAS Number: 152459-95-5<br>Other descriptive name: IMATINIB<br>Concentration unit: mg milligram(s)<br>Concentration type: range<br>Concentration number: 400-300<br><br>Trade Name: Olumiant<br>Pharmaceutical Form: Coated tablet<br>INN or Proposed INN: BARICITINIB<br>Other descriptive name: Olumiant<br>Concentration unit: mg milligram(s)<br>Concentration type: range<br>Concentration number: 4-2<br><br> | Main Objective: To compare and evaluate the efficacy of 3 treatment regimens (Hydroxychloroquine in combination with baricitinib, imatinib or lopinavir / ritonavir) in SARS-CoV-2 patients with severe pneumonia requiring admission, considering primary efficacy as time to clinical improvement.;Timepoint(s) of evaluation of this end point: Baseline, 7 days during treatment, day 14, day 35+/-5 and day 70+/-5;Primary end point(s): 8.1 Demographics<br>Age<br>Sex<br>Tobacco<br>Alcohol<br>Significant comorbidity<br>- HTA<br>- Cardiovascular disease<br>- DM<br>- COPD<br>- Cancer<br>- Chronic liver disease<br>- I kidney<br>- Known immunosuppression<br><br>8.2 Laboratory parameters<br>COVID BIOMARKERS<br>- PCR<br>- Procalcitonin<br>- LDH<br>- Dimero D<br>- Ferritin<br>- IL6<br>BIOCHEMICAL PARAMETERS<br>- Enzymatic creatinine<br>- ALT<br>- AST<br>- Bilirubin<br>- GGT<br>- F Alkaline<br>- Albumine<br>- Venous lactate<br>- Ultrasensitive Troponin I<br>- Creatin Kinasa (CK)<br><br>HEMATOLOGICAL PARAMETERS<br>- White Series<br>- Leukocytes (in absolute value)<br>- Neutrophils (in absolute value)<br>- Lymphocytes (in absolute value)<br>- Neutrophil / lymphocyte ratio<br>- Platelet / lymphocyte ratio<br>- Red Series<br>- erythrocytes<br>- Hb<br>- Platelets<br>- Coagulation<br>- Fibrinogen<br>- Coagulation Study<br><br>MICROBIOLOGICAL PARAMETERS<br>- SARS-Cov2 PCR in nasopharyngeal exudate<br><br>8.3 Radiodiagnosis<br>- Unilateral, unilobar, bilobar pneumonia ...<br>- Bilateral pneumonia<br>- Resolution infiltrators<br>- Infiltration resolution days<br>- Stabilization<br>- Radiological progression<br><br>8.4 Clinical variables<br>- Symptom onset days<br>- Days resolution symptoms<br>- Fever days<br>- Respiratory improvement (days)<br>- Temperature (<38.4 / 38.4-39.4 /> 39.4) * From The The Hscore11<br>- Organomegaly (No, liver or spleen, both) * From The Hscore11<br>- Fever<br>- Dry cough<br>- productive cough<br>- Hemoptysis<br>- dyspnea<br>- Asthenia<br>- Myalgia<br>- headache<br>- nausea<br>Vomiting<br>- Diarrhea<br>- Abdominal discomfort<br>- ARDS<br>- I cardiac<br>- FRA<br>- SHOCK<br>- death<br>- Secondary infection<br>- O2 saturation levels.<br>- Need O2, nasal goggles, liters VM non-invasive reservoir Intubation<br><br>8.5 Clinical management variables<br>- Hospital stay<br>- ICU admission<br>- No. of registrations;Secondary Objective: To assess the safety (serious adverse effects, premature discontinuation of treatment), tolerability and secondary efficacy parameters of the 3 treatment guidelines, understood as: absence of progression to respiratory failure, absence of increased O2 requirements; need for mechanical ventilation; reduction of analytical parameters associated with poor prognosis; radiological progression of the disease on day + 7 of starting treatment; average hospital stay, intensification treatments, such as steroid boluses and tocilizumab, ICU admission,% mortality at the end of follow-up.<br>In addition, in those patients who consent and participate in an additional sub-study, possible biomarkers and genetic markers of susceptibility to SARS-CoV-2 will be evaluated using high-performance techniques with serum DNA from the participants.→Timepoint(s) of evaluation of this end point: Baseline, 7 days during treatment, day 14, day 35+/-5 and day 70+/-5;Primary end point(s): 8.1 Demographics<br>Age<br>Sex<br>Tobacco<br>Alcohol<br>Significant comorbidity<br>- HTA<br>- Cardiovascular disease<br>- DM<br>- COPD<br>- Cancer<br>- Chronic liver disease<br>- I kidney<br>- Known immunosuppression<br><br>8.2 Laboratory parameters<br>COVID BIOMARKERS<br>- PCR<br>- Procalcitonin<br>- LDH<br>- Dimero D<br>- Ferritin<br>- IL6<br>BIOCHEMICAL PARAMETERS<br>- Enzymatic creatinine<br>- ALT<br>- AST<br>- Bilirubin<br>- GGT<br>- F Alkaline<br>- Albumine<br>- Venous lactate<br>- Ultrasensitive Troponin I<br>- Creatin Kinasa (CK)<br><br>HEMATOLOGICAL PARAMETERS<br>- White Series<br>- Leukocytes (in absolute value)<br>- Neutrophils (in absolute value)<br>- Lymphocytes (in absolute value)<br>- Neutrophil / lymphocyte ratio<br>- Platelet / lymphocyte ratio<br>- Red Series<br>- erythrocytes<br>- Hb<br>- Platelets<br>- Coagulation<br>- Fibrinogen<br>- Coagulation Study<br><br>MICROBIOLOGICAL PARAMETERS<br>- SARS-Cov2 PCR in nasopharyngeal exudate<br><br>8.3 Radiodiagnosis<br>- Unilateral, unilobar, bilobar pneumonia ...<br>- Bilateral pneumonia<br>- Resolution infiltrators<br>- Infiltration resolution days<br>- Stabilization<br>- Radiological progression<br><br>8.4 Clinical variables<br>- Symptom onset days<br>- Days resolution symptoms<br>- Fever days<br>- Respiratory improvement (days)<br>- Temperature (<38.4 / 38.4-39.4 /> 39.4) * From The The Hscore11<br>- Organomegaly (No, liver or spleen, both) * From The Hscore11<br>- Fever<br>- Dry cough<br>- productive cough<br>- Hemoptysis<br>- dyspnea<br>- Asthenia<br>- Myalgia<br>- headache<br>- nausea<br>Vomiting<br>- Diarrhea<br>- Abdominal discomfort<br>- ARDS<br>- I cardiac<br>- FRA<br>- SHOCK<br>- death<br>- Secondary infection<br>- O2 saturation levels.<br>- Need O2, nasal goggles, liters VM non-invasive reservoir Intubation<br><br>8.5 Clinical management variables<br>- Hospital stay<br>- ICU admission<br>- No. of registrations;Secondary Objective: To assess the safety (serious adverse effects, premature discontinuation of treatment), tolerability and secondary efficacy parameters of the 3 treatment guidelines, understood as: absence of progression to respiratory failure, absence of increased O2 requirements; need for mechanical ventilation; reduction of analytical parameters associated with poor prognosis; radiological progression of the disease on day + 7 of starting treatment; average hospital stay, intensification treatments, such as steroid boluses and tocilizumab, ICU admission,% mortality at the end of follow-up.<br>In addition, in those patients who consent and participate in an additional sub-study, possible biomarkers and genetic markers of susceptibility to SARS-CoV-2 will be evaluated using high-performance techniques with serum DNA from the participants.;Main Objective: To compare and evaluate the efficacy of 3 treatment regimens (Hydroxychloroquine in combination with baricitinib, imatinib or lopinavir / ritonavir) in SARS-CoV-2 patients with severe pneumonia requiring admission, considering primary efficacy as time to clinical improvement. | | | | No | False | | |
| EUCTR2020-001437-12-ES | 20 April 2020 | Random, controlled, open, one-site clinical trial in adult patients with COVID-19 severe pneumonia treated with immunomodulatory drugs | Random, controlled, open, one-site clinical trial in adult patients with COVID-19 severe pneumonia treated with immunomodulatory drugs | | Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR) | 13/04/2020 | 20200413 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001437-12 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 09/04/2020 | 290 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 4
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Spain | Salvador Augustin | | Passeig Vall d'Hebron, 119 | | 0034934893000 | Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR) | Inclusion criteria: <br>1. Age 18-80 years<br>2. Severe COVID-19 pneumonia definied as:<br>- Nasnopharyngeal smear SARS-CoV-2 PCR positive<br>- Pulmonary infiltrates by simple X-ray (or other technique) compatible with pneumonia<br>- One or more of the following criteria:<br>o Room air oxygen saturation <= 94% measured by pulse oximeter<br>o Pa:FiO2 (partial pressure O2/fraction of inspired O2) <=300<br>o Sa:FiO2 (O2 saturation measured by pulse oximeter/ fraction of inspired O2) <=350<br>3. Informed Consent according to protocol instructions.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 145<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 145<br> | Exclusion criteria: <br>1. GOT/GPT > 5 the institutional ULN<br>2. Neutrophils < 500 cell/mmc.<br>3. Petelet < 50.000 cell/mmc.<br>4. Documented sepsis o pneumonia different from COVID-19.<br>5. According to clinician criteria, comorbilities with poor prognosis<br>6. Compliate Diverticulitis or bowel perforation<br>7. Current skin infection (p.e piodermitis)<br>8. According to the clinician criteria, any contraindication for using inmunomodulator tretament.<br> | Severe COVID-19 pneumonia <br>MedDRA version: 21.1
Level: PT
Classification code 10035737
Term: Pneumonia viral
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Sandimmun<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: CICLOSPORIN<br>CAS Number: 59865-13-3<br>Concentration unit: mg/kg milligram(s)/kilogram<br>Concentration type: range<br>Concentration number: 10-15<br><br>Trade Name: RoActemra<br>Product Name: RoActemra<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: TOCILIZUMAB<br>CAS Number: 375823-41-9<br>Concentration unit: mg milligram(s)<br>Concentration type: range<br>Concentration number: 800-1200<br><br>Trade Name: Sandimmun<br>Pharmaceutical Form: Capsule, soft<br>INN or Proposed INN: CICLOSPORIN<br>CAS Number: 59865-13-3<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 75-<br><br> | Timepoint(s) of evaluation of this end point: Day 28 after treatment initiation;Primary end point(s): Mortality at day 28 after treatment initiation (proportion of patient died that day);Secondary Objective: To assess the impact of this strategy on the following variables: premature mortality (48 hours, 7 days and at hospital), mortality at intensive care unit, days of mechanical ventilation, virus clearance (viral clearance / viral shedding), time to normalization of oxygen saturation , time to defervescence, improvement of inflammatory reaction, days of hospitalization, days of intubation, safety and tolerability of the intervention;Main Objective: To assess the mortality impact at 28 days of an immunomodulatory strategy with 2 treatment regimens stratified according to IL-6 plasma levels, administered in addition to standard treatment, in adult patients with severe COVID-19 pneumonia. | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-001331-26-GB | 20 April 2020 | Preventative Drug Treatment for COVID-19 Infectious Disease | ChemoPROphyLaxIs For covId-19 infeCtious disease (the PROLIFIC trial) - PROLIFIC Trial (COVID-19) | | Cambridge University Hospitals NHS Foundation Trust | 14/04/2020 | 20200414 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001331-26 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 14/04/2020 | 1000 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Other specify the comparator: The same medicinal product at a different (lower) dosage will be used as a comparator.
Number of treatment arms in the trial: 3
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| United Kingdom | | | Cambridge University Hospitals NHS Foundation Trust, Addenbrooke's Hospital, Hills Road, Coton House | ccturegulatory@addenbrookes.nhs.uk | 01223348158 | Carrie Bayliss | Inclusion criteria: <br>To be included in the trial the participant MUST: <br>1) Have given written informed consent to participate <br>2) Be aged 18 years to 70 years<br>3) Not previously have been diagnosed with COVID-19<br>4) Work in a high-risk secondary or tertiary healthcare setting (hospitals accepting COVID-19 patients) with direct patient-facing care<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 900<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 100<br> | Exclusion criteria: <br>The presence of any of the following will mean participants are ineligible: <br>1) Known COVID-19 positive test at baseline (if available)<br>2) Symptomatic for possible COVID-19 at baseline<br>3) Known hypersensitivity reaction to HCQ, chloroquine or 4-aminoquinolines<br>4) Known retinal disease<br>5) Known porphyria<br>6) Known chronic kidney disease (CKD; eGFR<30ml/min)<br>7) Known epilepsy<br>8) Known heart failure or conduction problems<br>9) Known significant liver disease (Gilbert’s syndrome is permitted)<br>10) Known glucose-6-phosphate dehydrogenase (G6PD) deficiency<br>11) Currently taking any of the following contraindicated medications:<br>a. Digoxin<br>b. Chloroquine<br>c. Halofantrine<br>d. Amiodarone<br>e. Moxifloxacin<br>f. Cyclosporin<br>g. Mefloquine<br>h. Praziquantel<br>i. Ciprofloxacin<br>j. Clarithromycin<br>k. Prochlorperazine<br>l. Fluconazole<br>12) Currently taking hydroxychloroquine or having a clinical indication for taking hydroxychloroquine<br>13) Currently breastfeeding<br>14) Unable to be followed-up during the trial<br>15) Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies) before study follow-up visit<br>16) Not able to use or have access to a modern phone device/web-based technology<br>17) Any other clinical reason which may preclude entry in the opinion of the investigator<br><br> | Coronavirus disease 2019 (COVID-19) caused by the infection, SARS-CoV-2 <br>MedDRA version: 20.0
Level: LLT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Hydroxychloroquine<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Hydroxychloroquine<br>CAS Number: 118-42-3<br>Concentration unit: mg milligram(s)<br>Concentration type: up to<br>Concentration number: 200-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: Weekly over approximately 90 days;Primary end point(s): Time to positive COVID-19 disease <br>;Secondary Objective: • To determine whether giving hydroxychloroquine daily versus weekly decreases time to COVID-19 disease in healthy frontline healthcare workers<br>• To compare the number of confirmed COVID-19 cases between each group on the basis of different testing methods<br>• To compare disease severity in each group<br>• To compare recovery time in each group;Main Objective: The principle research objective is to determine whether giving the drug Hydroxychloroquine increases time to COVID-19 disease in healthy frontline healthcare workers compared to giving a placebo. | | | | Yes | False | | |
| → | EUCTR2020-001379-34-ES | 20 April 2020 | Sedation with sevoflurane versus propofol in patients with Acute Respiratory Distress Syndrome caused by COVID-19 infection | Sedation with sevoflurane versus propofol in patients with Acute Respiratory Distress Syndrome caused by COVID-19 infection | | Instituto de Investigación Sanitaria INCLIVA | 14/04/2020 | 20200414 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001379-34 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 14/04/2020 | 50 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Spain | Subdirectora Científica | | Avd. Menédez Pelayo 4 acc | gestioncientifica@incliva.es | 0034961973536 | Instituto de Investigación Sanitaria INCLIVA | Inclusion criteria: <br>- Age 18 years or more.<br>- Diagnosis of Acute Respiratory Distress Syndrome caused by COVID19 infection.<br>- Signature of Patient's Consent or Verbal Consent of Legal Representative<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 10<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 40<br> | Exclusion criteria: <br>- Intracranial hypertension<br>- Hypersensitivity to the active ingredient (propofol or sevoflurane) or to any of the excipients<br>- Current volume < 250ml<br>- History of malignant hyperthermia<br>- Liver failure<br>- Neutropenia (<0.5x109)<br>- Pregnant or lactating women<br>- Have received chemotherapy in the last month since their inclusion in the study<br> | Acute Respiratory Distress Syndrome caused by COVID19 infection <br>MedDRA version: 21.1
Level: PT
Classification code 10001052
Term: Acute respiratory distress syndrome
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
<br>MedDRA version: 20.0
Level: LLT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: SEVOFLURANE<br>Pharmaceutical Form: Inhalation vapour, liquid<br>INN or Proposed INN: SEVOFLURANE<br>CAS Number: 28523-86-6<br>Other descriptive name: SEVOFLURANE<br>Concentration unit: ml millilitre(s)<br>Concentration type: up to<br>Concentration number: 6-<br><br>Product Name: PROPOFOL<br>Pharmaceutical Form: Emulsion for suspension for injection<br>INN or Proposed INN: PROPOFOL<br>Other descriptive name: PROPOFOL<br>Concentration unit: mg/kg/h milligram(s)/kilogram/hour<br>Concentration type: up to<br>Concentration number: 2-<br><br> | Secondary Objective: - to quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 <br>- evaluate the 30-day mortality.;Primary end point(s): Efficacy will be assessed according to the defined objectives of oxygenation, reduction of inflammatory markers;Timepoint(s) of evaluation of this end point: 2 days - PaO2/FiO2 and TNF, IL-1b, IL-6 e IL-8 día 2.;Main Objective: To evaluate the effect of 48-hour treatment with inhaled sevoflurane on arterial oxygenation, assessed by PaO2/FiO2 on day two, in patients with ARDS-CoVid19→Timepoint(s) of evaluation of this end point: 2 days - PaO2/FiO2 and TNF, IL-1b, IL-6 e IL-8 día 2.;Primary end point(s): Efficacy will be assessed according to the defined objectives of oxygenation, reduction of inflammatory markers;Secondary Objective: - to quantify the effects of sevoflurane on pro-inflammatory cytokine levels during ARDS-CoVid19 <br>- evaluate the 30-day mortality.;Main Objective: To evaluate the effect of 48-hour treatment with inhaled sevoflurane on arterial oxygenation, assessed by PaO2/FiO2 on day two, in patients with ARDS-CoVid19 | | | | Yes | False | | |
| EUCTR2020-001682-36-ES | 20 April 2020 | Treatment of COVID-19 with allogeneic mesenchymal cells (MSV®). | Double-blind, placebo-controlled phase I/II clinical trial to evaluate the safety and efficacy of allogeneic mesenchymal stem cells (MSV®-allo) in acute respiratory failure in patients with COVID-19 pneumonia.
- Treatment of COVID.19 with allogeneic mesenchymal cells (MSV®). | | CITOSPIN S.L. | 14/04/2020 | 20200414 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001682-36 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 13/04/2020 | 24 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | CRO | | Paseo de la Castellana 127-1d | enrique.conde@efficeresearch.com | +34912948910 | Effice spi S.L. | Inclusion criteria: <br>1. Women or men of equal or more than 18 years of age 2. SARS-CoV-2 infection confirmed by<br>molecular testing. 3. Admitted to the Intensive Care Unit with pneumonia secondary<br>to COVID-19 infection in the last 48 hours, who meet at least one of these criteria:<br>to. Respiratory distress. yes. Respiratory rate (RR) equal or more than 30 rpm. C. Basal oxygen<br>saturation at rest equal or less than 93%. re. Arterial partial pressure of oxygen (PaO2) / inspiratory<br>fraction of oxygen (FiO2) equal or less than 300 mmHg. 4. Compliance of the patient or his legal<br>representative for participation in the study.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 24<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>1. Active tumor disease.<br>2. Pregnancy.<br>3. Participation in another active clinical trial.<br>4. Any circumstance that in the researcher's opinion justifies the patient's non-participation in the trial.<br>5. Not consent to participation.<br> | COVID-19 <br>MedDRA version: 20.0
Level: LLT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Células mesenquimales troncales adultas alogénicas de médula ósea expandidas en suspensión<br>Product Code: MSV®-allo<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: células mesenquimales troncales adultas alogénicas de médula ósea expandidas mediante procedimiento IBGM<br>Current Sponsor code: MSV_allo<br>Concentration unit: U/ml unit(s)/millilitre<br>Concentration type: equal<br>Concentration number: 10000000-<br>Pharmaceutical form of the placebo: Injection<br>Route of administration of the placebo: Intravenous use<br><br> | Main Objective: Assessing the safety and efficacy of MSV-allo® in obtaining recovery from respiratory failure in patients with pneumonia due to severe / critical COVID-19 infection.;Secondary Objective: 1. Time to recover from the symptoms and clinical signs after the MSV-allo® administration<br>2. Time to reach the normalization of imaging tests, chest radiography and/or lung CT<br>3. Modification in the inflammatory response in terms of blood levels of cytokines and chemokines.<br>4. Modification in the number of leukocytes and lymphocyte populations.<br>5. Safety, tolerability and immunogenicity profiles of MSV-allo® in patients with severe COVID-19;Primary end point(s): 1. Proportion of patients in whom removal of invasive mechanical ventilation has been achieved in less than 7 days after IMP administration.<br>2. Proportion of patients surviving on day 28 from diagnosis;Timepoint(s) of evaluation of this end point: 7 days from treatment and 28 days from diagnosis | | | | No | False | | |
| EUCTR2020-001511-25-ES | 20 April 2020 | Randomized open-blind controlled trial to study the benefit of Colchicine in Patients with COVID-19 | Randomized open-blind controlled trial to study the benefit of Colchicine in Patients with COVID-19 - COL-COVID | | FFIS | 15/04/2020 | 20200415 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001511-25 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 14/04/2020 | 102 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Spain | SPONSOR | | LUIS FONTES PAGAN 9 | Lola.serna@carm.es | 34968359763 | FFIS | Inclusion criteria: <br>1.Infection confirmed by SARS-CoV-2 by RT-PCR.<br>2. Hospital admission in the previous 48 hours for clinical involvement in groups 3, 4 or 5 of the WHO clinical scale.<br>3. Age over 18 years.<br>4. Granting of informed consent in writing.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 51<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 51<br> | Exclusion criteria: <br>1. Need for invasive ventilatory support<br>2. Limitation of therapeutic effort due to poor vital prognosis<br>3. Inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption.<br>4. Previous neuromuscular disease<br>5. Different disease with estimated life prognosis less than 1 year.<br>6. Severe kidney failure (glomerular filtration rate <30 mL / m in / 1.73m2)<br>7. History of cirrhosis, active chronic hepatitis, or severe liver disease defined by GOT (AST) or GPT (ALT) values ??that exceed 3 x upper limit of normality<br>8. Patient who is taking colchicine for other indications (mainly chronic prescriptions for family Mediterranean fever or gout) (No washout period will be required for patients who have been treated with colchicine and have stopped treatment before randomization).<br>9. Patient with a history of allergic reactions or significant sensitivity to colchicine.<br>10. Treatment with immunosoppressants, corticosteroids, interleukin-1 antagonists in the 6 months prior to inclusion.<br>11. Pregnant or lactating women, where pregnancy is defined as the state of a woman after conception and until the end of gestation, confirmed by a positive result in the analysis of human chorionic gonadotropin (hCG).<br>12. Fertile, or postmenopausal female patient less than 1 year old, and not surgically sterilized. Women of childbearing potential who are using at least one contraceptive method and preferably two complementary methods of contraception, including a barrier method (male or female condoms, spermicides, sponges, foams, contraceptive gels, diaphragms, intrauterine device) may be included throughout the entire study and up to 30 days after the end of the study.<br>13. Use of other investigational drugs at the time of enrollment, or during the 30 days prior to enrollment.<br> | COVID19;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Trade Name: COLCHICINE<br>Product Name: COLCHIMAX<br>Product Code: M04AX<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: COLCHICINA<br>CAS Number: 64-86-8<br>Other descriptive name: COLCHICINE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: .5-<br><br> | Timepoint(s) of evaluation of this end point: END OF STUDY;Primary end point(s): 1. Ordinal 7-point clinical evaluation scale (WHO R&D Blueprint expert group (31).<br>2. IL-6 concentrations, which together with the rest of the laboratory result variables will be measured together at the end of the study.;Secondary Objective: 1. Improvement of clinical status defined as time to reduction of at least 2 points on the WHO 7-point ordinal scale.<br>2. Changes in the Sequential Organ Failure Scale (SOFA,) during hospitalization and time to 50% reduction with respect to randomization.<br>3. Changes in NEWS severity scale score (33) during hospitalization and time to NEWS score =2 or 50% reduction from randomization.<br>4. Number of days in invasive mechanical ventilation or ECMO<br>5. Number of days with oxygen at high flow.<br>6. Changes of other inflammatory markers: C-reactive protein, TNF-alpha, GDF-15, IL-1ß up to 28 days with respect to randomization.<br>7. Changes in severity markers: D-dimer, leukocytes, lymphocytes, platelets, LDH and ferritin up to 28 days with respect to randomization.<br>8. Changes in markers of myocardial damage: hsTnT and NT-proBNP up to 28 days with respect to randomization.<br>9. Time to viral negative by RT-PCR<br>10. Duration in days of hospital stay<br>11. ICU income<br>12. Mortality from causes;Main Objective: To study whether the administration of colchicine, compared to a control group, improves the clinical evolution of patients and prevents the inflammatory response.<br>1. Changes in the clinical status of patients on the 7-point ordinal scale (WHO R&D Blueprint expert group) (34) at 7, 14 and 28 days:<br>2. Change in IL-6 concentrations up to 28 days. | | | | No | False | | |
| → | EUCTR2020-001448-24-GB | 20 April 2020 | Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 | Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19
- COVIDSurgRCT_v1.0_20200330 | | University of Birmingham | 17/04/2020 | 20200417 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001448-24 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 15/04/2020 | 6400 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: yes
Other specify the comparator: Control (normal practice)
Number of treatment arms in the trial: 4
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| India;United Kingdom;South Africa;Nigeria;Ghana | Donna Smith | | Public Health Building, | d.smith.6@bham.ac.uk | | University of Birmingham, Birmingham Clinical Trials Unit (BCTU) | Inclusion criteria: <br>Testing and criteria for diagnosis COVID-19 is likely to rapidly evolve over the course of this trial and will vary internationally. Therefore, the following pragmatic definitions will be applied:<br>• Confirmed positive test for COVID-19: either a laboratory test (performed according to each participating hospital’s local protocols) or a computed tomography (CT) thorax scan (based on individual radiologist interpretation and diagnosis) that confirms COVID-19 diagnosis.<br>• Confirmed negative test for COVID-19: a laboratory test (performed according to each participating hospital’s local protocols) that is negative for COVID-19 diagnosis.<br><br><br>Patients are eligible for the study if ALL of the following apply:<br>-Aged 18 years or above<br>-Planned to undergo any type of elective or emergency inpatient surgery requiring general or regional anaesthesia (such as vulnerable patients undergoing surgery for a fractured neck of femur)<br>-Asymptomatic of COVID-19, including patients with: those not tested, negative test results, postive test but no symptoms<br>-Able to provide informed patient consent<br><br>The eligibility criteria may change over time to reflect new diagnostic tests or changing epidemiology. This will be reviewed regularly by the Trial Management Group and Data Monitoring Committee. For example, if routine serological screening before surgery becomes feasible during the course of the trial in any participating hospital, only seronegative patients may be eligible for the trial.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 1000<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 4400<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 1000<br> | Exclusion criteria: <br>Patients are not eligible for the study if ANY of the following apply:<br><br>--Procedures under local anaesthesia<br>-Symptomatic COVID-19 infection (by confirmed COVID-19 test or a clinical diagnosis); these patients will be eligible for the RECOVERY trial.<br>-Existing regular preoperative treatment with trial drugs<br>-Known history of adverse reaction/contraindication to trial drugs<br>-Pregnancy (including caesarean section)<br><br><br>It is anticipated that very few patients listed for surgery will have symptomatic COVID-19 infection at the time of surgery, and although any such patients will be excluded from this trial, they will be eligible for the parallel RECOVERY trial.<br> | Preventing Pulmonary Complications in Surgical Patients at Risk of COVID-19 <br>MedDRA version: 20.0
Level: PT
Classification code 10035664
Term: Pneumonia
System Organ Class: 10021881 - Infections and infestations
<br>MedDRA version: 21.1
Level: LLT
Classification code 10003083
Term: ARDS
System Organ Class: 100000004855
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Lopinavir-Ritonavir <br>Product Name: Lopinavir-Ritonavir <br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: Lopinavir<br>Other descriptive name: Antiretroviral<br>Concentration unit: mg/g milligram(s)/gram<br>Concentration type: equal<br>Concentration number: 200-<br>INN or Proposed INN: Ritonavir<br>Concentration unit: mg/g milligram(s)/gram<br>Concentration type: equal<br>Concentration number: 50-<br><br>Trade Name: Hydroxychloroquine (Plaquenil) <br>Product Name: Hydroxychloroquine (Plaquenil) <br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: Hydroxychloroquine sulfate<br>Other descriptive name: Antimalarial, Aminoquinoline<br>Concentration unit: mg milligram(s)<br><br> | Timepoint(s) of evaluation of this end point: Up to 30 days following surgery;Primary end point(s): Trial outcomes will only be based on routinely available data. Patients will not undergo any additional investigations for trial purposes.<br><br>Primary outcome measure<br>The primary outcome is any one of the following COVID-19 specific, inpatient, postoperative pulmonary complications (definitions are given in an Appendix in the protocol and through brief online training):<br>• Pneumonia<br>• Acute respiratory distress syndrome (ARDS)<br>• Death<br><br>Definitions for each outcome are provided in the protocol. The components of the composite outcome have all been internationally validated. The feasibility of collecting these endpoints within routine care pathways has been demonstrated by our RECON cohort (11,500 patients, 4 countries).<br><br>;Secondary Objective: To assess the effects of study treatments on:<br>-Post-operative proven COVID-19 pulmonary complications<br>-Overall SARS-CoV-2 infected rate<br>-Duration of intensive care and total hospital stay<br>-Pulmonary function in keeping with WHO Solidarity Trial outcome scale <br>-Safety and tolerability of study treatments<br><br>;Main Objective: Primary Objective<br><br>To provide reliable estimates of the effect of study treatments on postoperative pulmonary complications during the COVID-19 pandemic. →Primary end point(s): Trial outcomes will only be based on routinely available data. Patients will not undergo any additional investigations for trial purposes.<br><br>Primary outcome measure<br>The primary outcome is any one of the following COVID-19 specific, inpatient, postoperative pulmonary complications (definitions are given in an Appendix in the protocol and through brief online training):<br>• Pneumonia<br>• Acute respiratory distress syndrome (ARDS)<br>• Death<br><br>Definitions for each outcome are provided in the protocol. The components of the composite outcome have all been internationally validated. The feasibility of collecting these endpoints within routine care pathways has been demonstrated by our RECON cohort (11,500 patients, 4 countries).<br><br>;Timepoint(s) of evaluation of this end point: Up to 30 days following surgery;Secondary Objective: To assess the effects of study treatments on:<br>-Post-operative proven COVID-19 pulmonary complications<br>-Overall SARS-CoV-2 infected rate<br>-Duration of intensive care and total hospital stay<br>-Pulmonary function in keeping with WHO Solidarity Trial outcome scale <br>-Safety and tolerability of study treatments<br><br>;Main Objective: Primary Objective<br><br>To provide reliable estimates of the effect of study treatments on postoperative pulmonary complications during the COVID-19 pandemic. | | | | No | False | | |
| EUCTR2020-001570-30-FR | 20 April 2020 | ICAR (IgIV in Covid-related ARds) | Interest of early treatment with polyvalent immunoglobulins in the management of respiratory distress syndrome associated with SARS-CoV-2 infections_COVID-19 - ICAR (IgIV in Covid-related ARds) | | GHU PARIS PSYCHIATRIE ET NEUROSCIENCES | 06/04/2020 | 20200406 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001570-30 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 09/04/2020 | 126 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| France | AWASSI | | 1 RUE CABANIS | v.awassi@ghu-paris.fr | 33145657401 | GHU PARIS PSYCHIATRIE ET NEUROSCIENCES | Inclusion criteria: <br>1) VM (mechanical ventilation) invasive for less than 36 hours
<br>2) ARDS meeting the Berlin criteria (Ref)
<br>3) SARS-CoV-2 infection proven by PCR
<br>4) Consent of the patient, a relative or relative or deferred (emergency clause).<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 126<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>- Allergy to polyvalent immunoglobulins.
<br>- Pregnant woman or minor patient
<br>- Known IgA deficiency.
<br>- Patient with renal failure on admission defined by a 3-fold increase in baseline creatinine or serum creatinine> 354 micromol / L or a diuresis of less than 0.3 mL / Kg for 24 hours or anuria for 12 hours.
<br>- Participation in another interventional trial<br> | Cov-2 SARS Disease <br>MedDRA version: 20.0
Level: LLT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Trade Name: Clairyg 50mg/ml, Solution for infusion<br>Product Name: Clairyg 50mg/ml, Solution for infusion<br>Product Code: J06BA02<br>Pharmaceutical Form: Infusion<br>Pharmaceutical form of the placebo: Infusion<br>Route of administration of the placebo: Intravenous use<br><br> | Timepoint(s) of evaluation of this end point: 28 day delay;Primary end point(s): Survival without invasive ventilatory assistance (i.e. ventilator-free days) until D28. The score is calculated by summing the days on which the patient has not had a VM; but in the event of death before D28, the score is zero. The 28-day delay was recommended because the average duration of VM for post-SARS-CoV-2 ARDS patients is 20 days.;Secondary Objective: The secondary objectives are to assess the impact of IVIg on mortality, organ failure, complications of resuscitation and the functional and psychological sequelae at D28 as well as their side effects.;Main Objective: To determine if the administration of IVIG at a dose of 2 g / kg over 4 consecutive days (i.e. 0.5 g / Kg / D) started during the first 24 to 120 hours of invasive mechanical ventilation (VM) of a patient suffering from d 'A post-SARS-CoV-2 ARDS improves the number of days living without VM on D28.<br> | | | | Yes | True | parent | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| IRCT20100228003449N29 | 21 April 2020 | ?Effect of sofosbuvir/ ledipasvir on COVID-19 | Evaluating efficacy and safety of sofosbuvir/ ledipasvir in treatment of COVID-19 | | Tehran University of Medical Sciences | 2020-03-19 | 20200319 | IRCT | http://en.irct.ir/trial/46567 | Recruiting | No | 18 years | 75 years | Both | 2020-03-18 | 50 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done according to the blocks randomization method. Regarding to the sample size, 5 patients will be include in each block. SAS procedure PROC PLAN will be applied to generate the randomization schedule.
This is a non-blinded randomized clinical trial. | 2-3 | Iran (Islamic Republic of) | Hossein Khalili | | Department of Clinical Pharmacy, Faculty of Pharmacy, Tehran University of Medical Sciences, 16 Azar Ave., Tehran, Iran | khalilih@tums.ac.ir | +98 21 6695 4715 | Tehran University of Medical Sciences | Inclusion criteria: Patients with highly suspected diagnosis of COVID-19<br>Patients with confirmed diagnosis of COVID-19<br>Patients who are candid for hospitalization<br>Patients who are candid for starting triple-drug combination | Exclusion criteria: History of drug allergy<br>Pregnancy<br>Lactation | COVID-19 pneumonia. | Intervention 1: Intervention group: Concomitant with the national corona treatment recommendation (Tab hydroxychloroquine 400 mg twice daily at day 1 then 200 mg twice daily plus Tab lopinavir/ritonavir 200/50 mg two tablets twice daily for at least 5 days), patients will receive one tablet of sofosbuvir/ledipasvir 400/100 mg (Danesh Pharmaceutical Development Company) daily for 10 days. Intervention 2: Control group: Patients will receive the national corona treatment recommendation (Tab hydroxychloroquine 400 mg twice daily at day 1 then 200 mg twice daily plus Tab lopinavir/ritonavir 200/50 mg two tablets twice daily for at least 5 days). | Response to the treatment (improvement of patients' chief complaint, abnormal paraclinic and radiologic findings). Timepoint: Daily. Method of measurement: According the clinical, paraclinical and laboratory findings.;Gastrointestinal complications. Timepoint: Daily. Method of measurement: Interview and patient's record.;Cutaneous complications. Timepoint: Daily. Method of measurement: Interview and patient's record.;Neurological complications. Timepoint: Daily. Method of measurement: Interview and patient's record.;Renal complications. Timepoint: Daily. Method of measurement: Interview and patient's record.;Hematological complications. Timepoint: Daily. Method of measurement: Interview and patient's record. | | | | No | False | | |
| → | IRCT20200317046797N1 | 21 April 2020 | Effect of Camostate mesylate on the outcome of Coronavirus (COVID-19)-induced pneumonia | Effect of Camostate mesylate on clinical improvement and outcome of Coronavirus (COVID-19)-induced pneumonia | | Tabriz University of Medical Sciences | 2020-04-03 | 20200403 | IRCT | http://en.irct.ir/trial/46573 | Recruiting | No | 18 years | 80 years | Both | 2020-04-08 | 40 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Simple randomization sequence will be generated with a computer from 1 to 40. The computer will divide the digits between the two groups. According to the sequence of admission, the patients will be allocated to the control or the Camostate mesylate groups regarding the sequence of computerized random list. | 3 | Iran (Islamic Republic of) | Dr Khalil Ansarin | | Imam Reza Hospital; Golgasht street | dr.ansarin@gmail.com | +98 41 3335 2898 | Tabriz University of Medical Sciences | Inclusion criteria: Moderate to severe 2019-nCoV-infected patients<br>Being at the age of 18 to 80 years<br>Patients or authorized family members volunteered to participate in this study and signed informed consent.<br>Both genders<br>pulmonary involvement in CT scan<br>PCR positive | Exclusion criteria: Patient with elevated liver enzymes 3 time the upper limit of normal<br>Patients who are participating in other drug clinical trials<br>Patients with active pulmonary tuberculosis<br>Patients with definite bacterial and fungal infections<br>Pregnant or lactating women<br>Patient with active thrombotic event | Condition 1: Coronavirus (COVID-19)-induced pneumonia. Condition 2: COVID-19. <br>Other viral pneumonia <br>COVID-19, virus identified;J12.89;U07.1 | Intervention 1: Intervention group: Twenty patients with Coronavirus (COVID-19)-induced pneumonia in addition to standard regimen of covid-19, will receive Camostate mesylate tablets for 3 days (200 mg three times daily). Intervention 2: Control group: they will receive standard regimen for COVID-19 patients. | Lung symptoms. Timepoint: At baseline (before intervention) and after drug administration. Method of measurement: Lung CT scan.;Hospitalization period. Timepoint: At baseline and discharge time. Method of measurement: Counting the day.;Mortality rate. Timepoint: At baseline and discharge time. Method of measurement: Observation.;Need for intubation. Timepoint: At baseline and discharge time. Method of measurement: Observation.→Need for intubation. Timepoint: At baseline and discharge time. Method of measurement: Observation.;Mortality rate. Timepoint: At baseline and discharge time. Method of measurement: Observation.;Hospitalization period. Timepoint: At baseline and discharge time. Method of measurement: Counting the day.;Lung symptoms. Timepoint: At baseline (before intervention) and after drug administration. Method of measurement: Lung CT scan. | | | | Yes | False | | |
| IRCT20160625028622N1 | 21 April 2020 | The effect of Noscapine on clinical and pulmonary manifestations of COVID-19 patients | The effect of NOSCOVID on pulmonary & other clinical manifestations of COVID-19 patients | | Qazvin University of Medical Sciences | 2020-03-22 | 20200322 | IRCT | http://en.irct.ir/trial/46576 | Not Recruiting | No | 2 years | no limit | Both | 2020-03-19 | 125 | interventional | Randomization: Not randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study patients, nurse , supervisor and researcher don't know which group of patients will use the medicine.
Physician and clinicians team know about the drug and group who use the drug. | 2 | Iran (Islamic Republic of) | Dr Ehsan Aali | | Bahonar | en.aali@gmail.com | +98 28 3333 6001 | Qazvin University of Medical Sciences | Inclusion criteria: Positive PCR test for Coronavirus (SARS-COV2)<br>CT Scan finding | Exclusion criteria: Patient who use warfarin<br>Patient who ACEI (captopril. enalapril,... ) | Novel Cronavirus Disease (COVID-19). <br>?????? ?????? ?????;COVID-19 | Intervention 1: Intervention group: Treatment group which received Noscapine mg, tds. Intervention 2: Control group: Group receiving Placebo with no API. | Cough. Timepoint: Daily. Method of measurement: Clinical finding.;O2 Saturation. Timepoint: daily. Method of measurement: Pulse Oximeter.;Radiographic features Findings. Timepoint: Before/After. Method of measurement: Radiography- CT SCAN. | | | | No | False | | |
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| ISRCTN51255782 | 27 April 2020 | Can the Ava fertility tracker device detect early signs of COVID-19? | Defining the role of a fertility bracelet for early recognition and monitoring of COVID-19 in Liechtenstein: an observational study (COVI-GAPP) | | labormedizinisches zentrum Dr. Risch | 14/04/2020 | 20200414 | ISRCTN | http://isrctn.com/ISRCTN51255782 | Recruiting | No | | | Both | 14/04/2020 | 2170 | Observational | Single-center observational study (Diagnostic) | Not Applicable | Liechtenstein | Lorenz | Risch | Wuhrstrasse 14 | lorenz.risch@risch.ch | +41 585233000 | | Inclusion criteria: <br> 1. Resident in Liechtenstein<br> 2. Aged 35-51 years<br> | Exclusion criteria: <br> 1. Aged under 18 years<br> 2. Inability to provide informed consent<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> In a first phase, participants (n=2170) of the population-based GAPP study (https://doi.org/10.4414/smw.2013.13728) will be contacted to be recruited for the COVI-GAPP study. After a first phase of including participants from the GAPP study, we eventually might attain a sample size of 5000 participant by opening the inclusion criteria by onboarding additional participants residing in Liechtenstein. The second phase is depending on obtaining the funding.<br> Participants will be asked to use a wearable device called the AVA bracelet (https://www.avawomen.com) during the night until the study is terminated. Temperature, breath rate, pulse rate and movements are recorded. Information on COVID-19-specific health status is collected at study start and symptomatic patients will be diagnosed for COVID-19, as recommended by national guidelines. At the end of the study blood will be drawn for serological analysis of anti-SARS-CoV2 antibodies.<br> | Occurrence of COVID-19 infection, as assessed by clinical signs, serology and/or RT-PCR testing. Date of occurrence, clinical symptoms and laboratory results will be collected. The endpoints will be collected by periodic monthly reports obtained on questioning the study participants. Participants and the treating healthcare institutions will be contacted to obtain respective information. | | 31/12/2021 | | Yes | False | | |
| → | ISRCTN80453162 | 27 April 2020 | The impact of the COVID-19 pandemic on the provision, practice, and outcomes of vascular surgery (COVER study) | The impact of the COVID-19 pandemic on the provision, practice, and outcomes of vascular surgery. An international cohort study (COVER) | | University Hospitals Coventry and Warwickshire NHS Trust | 14/04/2020 | 20200414 | ISRCTN | http://isrctn.com/ISRCTN80453162 | Recruiting | No | | | Both | 09/04/2020 | 200 | Observational | Observational longitudinal study (Other) | Not Applicable | Georgia;Germany;Ghana;Gibraltar;Greece;Greenland;Grenada;Guadeloupe;Guam;Guatemala;Guernsey;Guinea;Guinea-Bissau;Guyana;Haiti;Heard Island and Mcdonald Islands;Holy See (Vatican City State);Honduras;Hong Kong;Hungary;Gambia;Gabon;French Southern Territories;French Polynesia;French Guiana;France;Finland;Fiji;Faroe Islands;Falkland Islands;Ethiopia;Estonia;Eritrea;Equatorial Guinea;El Salvador;Egypt;Ecuador;Dominican Republic;Dominica;Djibouti;Denmark;Czech Republic;Cyprus;Curacao;Iceland;Liberia;Libya;Liechtenstein;Lithuania;Luxembourg;Macao;Macedonia;Madagascar;Malawi;Malaysia;Maldives;Mali;Malta;Marshall Islands;Martinique;Mauritania;Mauritius;Mayotte;Mexico;Micronesia, Federated States of;Moldova;Monaco;Mongolia;Montenegro;Montserrat;Morocco;Mozambique;Myanmar;Namibia;Nauru;Nepal;Netherlands;India;Indonesia;Iran;Iraq;Ireland;Isle of Man;Israel;Italy;Jamaica;Japan;Jersey;Jordan;Kazakhstan;Kenya;Kiribati;Korea, North;Korea, South;Kosovo;Kuwait;Kyrgyzstan;Laos;Latvia;Lebanon;Lesotho;Netherlands Antilles;New Caledonia;New Zealand;Nicaragua;Niger;Nigeria;Niue;Norfolk Island;Northern Mariana Islands;Norway;Oman;Pakistan;Palau;Palestinian Territory;Panama;Papua New Guinea;Paraguay;Peru;Philippines;Pitcairn;Poland;Portugal;Puerto Rico;Qatar;Reunion;Romania;Russian Federation;Rwanda;Saint Barthelemy;Saint Helena;Saint Kitts and Nevis;Saint Lucia;Saint Martin (French part);Saint Pierre and Miquelon;Saint Vincent and the Grenadines;Samoa;San Marino;Sao Tome and Principe;Saudi Arabia;Senegal;Serbia;Seychelles;Sierra Leone;Singapore;Sint Maarten (Dutch part);Slovakia;Slovenia;Solomon Islands;Somalia;South Africa;South Georgia and the South Sandwich Is;South Sudan;Spain;Sri Lanka;Sudan;Suriname;Svalbard and Jan Mayen;Swaziland;Sweden;Switzerland;Syria;Taiwan;Tajikistan;Tanzania;Thailand;Timor-Leste;Togo;Tokelau;Tonga;Trinidad and Tobago;Tunisia;Turkey;Turkmenistan;Turks and Caicos Islands;Tuvalu;Uganda;Ukraine;United Arab Emirates;United Kingdom;United States Minor Outlying Islands;United States of America;Uruguay;Uzbekistan;Vanuatu;Venezuela;Viet Nam;Virgin Islands, British;Virgin Islands, U.S.;Wallis and Futuna;Western Sahara;Yemen;Zambia;Zimbabwe;Afghanistan;Albania;Algeria;American Samoa;Andorra;Angola;Anguilla;Antarctica;Antigua and Barbuda;Argentina;Armenia;Aruba;Australia;Austria;Azerbaijan;Bahamas;Bahrain;Bangladesh;Barbados;Belarus;Belgium;Belize;Benin;Bermuda;Bhutan;Bolivia;Bonaire Saint Eustatius and Saba;Bosnia and Herzegovina;Botswana;Bouvet Island;Brazil;British Indian Ocean Territory;Brunei;Bulgaria;Cuba;Croatia;Cote d'Ivoire;Costa Rica;Cook Islands;Congo, Democratic Republic;Congo;Comoros;Colombia;Cocos (Keeling) Islands;Christmas Island;China;Chile;Chad;Central African Republic;Cayman Islands;Cape Verde;Canada;Cameroon;Cambodia;Burundi;Burkina Faso | Ruth;Sandip→Sandip;Ruth | Benson;Nandhra | Vascular and Endovascular Research Network (President);Vascular and Endovascular Research Network | vern.arterial.disease@gmail.com;vern.arterial.disease@gmail.com | +44 (0)121 4143344;+44 (0)191 2336161 | ; | Inclusion criteria: Any patient with a vascular condition | Exclusion criteria: Does not meet inclusion criteria | Any vascular condition, including: aortic or other type of aneurysmal disease, peripheral arterial disease, venous disease, vascular malformations, trauma, major haemorrhage, access (for renal dialysis), carotid (and cerebrovascular) disease, any other type of pathology treated by vascular surgeons. <br>Circulatory System | <br> This project is a three-tiered study designed to fully elucidate the impact of the COVID-19 pandemic on vascular surgery across the world.<br><br> The aim of Tier 1 is to document how the provision and availability of vascular services evolves over time per unit/region/country.<br><br> The aim of Tier 2 is to prospectively capture data on all vascular procedures performed during the pandemic and understand the impact on outcomes in the short and medium-term (up to 1 year).<br><br> The aim of Tier 3 is to document (prospectively) deviations from standards of care/practice during the pandemic in vascular patients.<br><br> The main objective of the COVER study is to understand and evaluate the impact of the COVID-19 pandemic on global vascular practice and the effect on outcomes for patients presenting/receiving treatment during the pandemic.<br> Population (patients) – All patients with a vascular pathology.<br> Outcome of interest – Tier 1: state of vascular services per centre weekly; Tier 2: procedures performed in each centre; Tier 3: assessment of longer-term outcomes.<br> Time – end of study 12 months after the end of the COVID19 pandemic.<br><br> The study is formally supported by the Vascular Society of Great Britain and Ireland (VSGBI), the British Society for Endovascular Therapy (BSET), the Rouleaux Club, the NIHR, SingVasc and several national vascular surgery societies in Europe, Asia, Australia, New Zealand, and the Americas.<br> | <br> 1. Structure and processes within the vascular service measured using a novel online questionnaire weekly until the end of data collection<br> 2. Document all vascular surgery and interventional procedures performed using an online purpose-built data collection tool (per centre/patient) at baseline, time/date of surgery, date of discharge from hospital, three, six, and twelve months:<br> 2.1. Type of procedure performed<br> 2.2. Time taken from presentation to the surgical team to intervention<br> 2.3. Mode of referral (primary vs. secondary care)<br> 2.4. Site of surgery – hub or spoke hospital<br> 2.5. Imaging modalities used and timings<br> 2.6. Emergency classification i.e. urgent/emergency/elective<br> 2.7. Operative technique(s) and device(s) used<br> 2.8. Mode(s) of anaesthesia (local, regional, general, locoregional, other)<br> 2.9. Whether suspected or confirmed COVID-19 positive (+ve) at time of surgery, COVID-19 +ve after surgery, or COVID-19 negative (-ve)<br> 2.10. Documentation of changes to usual practice for this specific procedure as per surgeon’s standard protocol (type of procedure, type of anaesthetic, post-procedural destination)<br> 3. Management of all referred urgent vascular cases using the online survey, focusing on:<br> 3.1. Chronic Limb Threatening Ischaemia (CLTI):<br> 3.1.1. Decision to discharge/admit/refer to a "hot"/emergency clinic<br> 3.1.2. Decision for endovascular or open surgery first<br> 3.1.3. Decision for best medical therapy or palliation or primary amputation<br> 3.2. Carotid disease:<br> 3.2.1. Number of patients managed with best medical therapy (BMT)<br> 3.2.2. Modifications to the indication and decision for carotid endarterectomy (CEA)<br> 3.2.3. Delays to treatment due to lack of theatre/bed availability<br> 3.3. Abdominal Aortic Aneurysm (AAA)<br> 3.3.1. Increasing use of Endovascular repair (if applicable)<br> 3.3.2. Changes to criteria for intervention<br> 3.3.3. Decisions for palliation, i.e. ‘turn down’<br> 3.4. Acute Aortic syndrome (AAS)<br> 3.4.1. Decision to manage in non-critical care beds<br> 3.4.2. Changes to imaging protocol at unit level<br> 3.4.3. Decision to defer surgery<br> | | 01/04/2022 | | No | False | | |
| → | EUCTR2020-001329-30-AT | 29 April 2020 | Therapy with Inhaled Nitric Oxide for Patients Infected with Coronavirus Suffering form Lung Failure | Inhaled Nitric Oxide Gas Therapy in Mechanically Ventilated Patients with Severe Acute Respiratory Syndrome in COVID-19 - NOSARSCOVID19 | | Massachussetts General Hospital | 03/04/2020 | 20200403 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001329-30 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 09/04/2020 | 200 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: yes<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Control group not treated with inhaled nitric oxide<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| China;Austria;United States | Clinical Research Division | | 55 Fruit Street | | 0016177269252 | Massachussetts General Hospital | Inclusion criteria: <br>1. Adult patients, > 18 year-old<br>2. Patients admitted to the ICU<br>3. Patients who are intubated and mechanically ventilated;<br>4. Confirmed diagnosis of SARS-CoV2 by positive rt-PCR;<br>5. Severe hypoxemia, defined by PaO2/FiO2 < 300 mmHg.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 100<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 100<br> | Exclusion criteria: <br>1. Patients intubated for more than 72 hours from initiation of the treatment gas<br>2. Physician of record opposed to enrolling the patient due to perceived safety concerns or any condition that does not allow the protocol to be followed safely<br> | ARDS caused by COVID-19 infection;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Inhaled nitric oxide<br>Product Code: n.a.<br>Pharmaceutical Form: Inhalation solution<br>INN or Proposed INN: NITRIC OXIDE<br>CAS Number: 10102-43-9 <br>Other descriptive name: Nitrogen monoxide<br>Concentration unit: PPM part per million<br>Concentration type: range<br>Concentration number: 1-80<br><br> | Main Objective: To assess the rate of change in oxygenation <br><br>;Secondary Objective: To assess an improvement in survival, organ damage and weaning from mechanical ventilation in SARS-CoV-2 patients. This would indicate an effect that cannot be addressed only the amelioration of V/Q mismatching in the course of a disease characterized by pneumonia and, in most severe cases, multiorgan failure.<br><br>To assess the time at which a patient is negative for SARS-CoV2, reflective of a possible antiviral effect.;Primary end point(s): Difference in oxygenation between the two groups;Timepoint(s) of evaluation of this end point: 48 hours→Timepoint(s) of evaluation of this end point: 48 hours;Primary end point(s): Difference in oxygenation between the two groups;Secondary Objective: To assess an improvement in survival, organ damage and weaning from mechanical ventilation in SARS-CoV-2 patients. This would indicate an effect that cannot be addressed only the amelioration of V/Q mismatching in the course of a disease characterized by pneumonia and, in most severe cases, multiorgan failure.<br><br>To assess the time at which a patient is negative for SARS-CoV2, reflective of a possible antiviral effect.;Main Objective: To assess the rate of change in oxygenation <br><br> | | | | Yes | False | | |
| EUCTR2020-001527-14-NL | 29 April 2020 | COVID-19: addition of azithromycin to chloroquine treatment | COVID-19: addition of azithromycin to chloroquine treatment - CO VOR IT | | Erasmus MC | 06/04/2020 | 20200406 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001527-14 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 21/04/2020 | 60 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Netherlands | J.G.J.V. Aerts | | Dr. Molewaterplein 40 | j.aerts@erasmusmc.nl | 00310107040704 | Erasmus MC | Inclusion criteria: <br>• Proven diagnosis of COVID-19 by positive PCR in any specimen < 48 hours prior to randomization.<br>• Age = 18 year <br>• Hospitalized patients with illness of any duration, and SpO2 = 94% on room air <br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 30<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 30<br> | Exclusion criteria: <br>• Severe hypoxemic respiratory failure expected to die < 72 hours after admission<br>• ICU admission < 72 hours<br>• Allergy for chloroquine or azithromycin<br>• Pregnancy<br>• QT-prolongation: pre-existent: QTc males >450ms, QTc females > 470ms at day 1 and at day 2<br>• Myasthenia gravis<br>• Epilepsy<br><br> | COVID-19;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: chloroquine<br>Product Code: RVG 106659<br>Pharmaceutical Form: Tablet<br><br>Product Name: azithromycin<br>Product Code: RVG 117670<br>Pharmaceutical Form: Tablet<br><br> | Timepoint(s) of evaluation of this end point: days of admission to day of discharge<br>primary endpoint will be determined at day 7;Primary end point(s): The initial response to treatment will be evaluated during admission. <br>Cure is considered when 3 criteria are present:<br>(1) O2 sat > 94% with room air<br>(2) 24 hours without fever (=38°C) <br>(3) Breathing frequency < 24/min<br><br>The percentage of patients with clinical cure at day 7 will be calculated<br>;Secondary Objective: Does addition of azithromycin to standard chloroquine treatment result in a higher viral clearance rate at day 7 confirmed by a negative COVID-19 PCR than treatment with chloroquine alone in patients with COVID-19.;Main Objective: Does addition of azithromycin to standard chloroquine treatment result in a higher clinical cure rate at day 7 than treatment with chloroquine alone in patients with COVID-19.<br><br>Cure is considered when 4 criteria are present:<br>(1) O2 sat > 94% with room air<br>(2) 24 hours without fever (=38°C) <br>(3) Breathing frequency < 24/min<br> | | | | Yes | False | | |
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| ChiCTR2000032635 | 11 May 2020 | Study for Screening of Chinese Patent Drugs in the Rehabilitation Treatment of novel coronavirus pneumonia (COVID-19) | A randomized, double-blind, placebo, parallel controlled trial for Pien-Tze-Huang Capsules in treating convalescent novel coronavirus pneumonia (COVID-19) patient with SARS-CoV-2 positive. | | Hubei Provincial Hospital of TCM | 2020-05-04 | 20200504 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=52671 | Not Recruiting | No | 18 | 70 | Both | 2020-05-06 | Control group:30;Experimental group:30; | Interventional study | Parallel | 0 | China | He Shaobin | | 856 Luoyu Road, Hongshan District, Wuhan, Hubei, China | heshaobin@hbhtcm.com | +86 18986261166 | Hubei Provincial Hospital of TCM | Inclusion criteria: (1) Patients who meet the COVID-19 diagnostic criteria and discharge standards, but the later SARS-CoV-2 virus nucleic acid test is positive;
<br>(2) Aged 18 to 70 years old;
<br>(3) Signed informed consent. | Exclusion criteria: 1. Accompanied by severe basic diseases affecting survival, including uncontrolled clinically significant heart, kidney, digestive, blood diseases, neuropsychiatric diseases, immune diseases, metabolic diseases, malignant tumors, severe malnutrition, etc.;
<br>2. Unstable angina pectoris or myocardial infarction in the last 1 month;
<br>3. Allergic constitution, allergic to the drug ingredients involved in the treatment program;
<br>4. Pregnant or nursing women;
<br>5. Mental state cannot cooperate, suffer from mental illness, have no self-control, cannot express clearly;
<br>6. Participating in other clinical trials;
<br>7. According to the judgment of the researchers, patients who will be included in the group will have complications or poor compliance, which will affect the efficacy and safety evaluation. | Novel coronavirus pneumonia (COVID-19) | Control group:the basic treatment withThymosin enteric capsule + Pien Tze Huang Capsules placebo;Experimental group:the basic treatment with Thymosin enteric capsule +Pien Tze Huang Capsules; | Qualitative RT-PCR results of SARS-CoV-2 nucleic acid of oral / nasopharyngeal swabs, anal swabs, sputum and blood ; | | | | Yes | False | | |
| → | EUCTR2020-001700-42-FR | 11 May 2020 | Efficacy of captopril in Covid-19 patients suffering of pneumonia | Efficacy of captopril nebulization in Covid-19 patients suffering of SARS-CoV-2 pneumonia.
A randomized phase II study
- CAPTOCOVID | | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP) | 11/04/2020 | 20200411 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001700-42 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 06/05/2020 | 230 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Standard of care according to Surviving-Covid-campaign
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| France | DRCI Hôpital St Louis | | 1 av. Claude Vellefaux | france.guyot@aphp.fr | | ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS | Inclusion criteria: <br>1- Hospitalization for acute respiratory failure requiring oxygen administration =3L/mn<br>2- Age > 18 years or older<br>3- Presence of pneumonia<br>4- PCR SARS-CoV-2 positive in any biological sample in the last 7 days<br>5- Patient affiliated to social security regime<br>6- Written informed consent provided by the patient or alternatively by next-of-kin, or in emergency situations, prior to any protocol-specific procedures<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 115<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 115<br> | Exclusion criteria: <br>1- Decision of withholding invasive mechanical ventilation<br>2- Shock requiring vasopressor infusion<br>3- Co-infection with another respiratory pathogen which could be responsible of pneumonia<br>4- Hypersensitivity to captopril, to any other angiotensin converting enzyme inhibitor or any of the excipients of the specialty used<br>5- History of angio-oedema<br>6- History of ACE-inhibitor allergy<br>7- Known pregnancy or current lactation: Female subject of childbearing potential should have a negative serum<br>pregnancy test prior to receiving the first dose of study medication.<br>8- Patient who is currently enrolled in other investigational study;<br>9- Persons deprived of their liberty by judicial or administrative decision,<br>10- Persons under legal protection/safeguard of justice,<br>11- Patients under duress psychiatric care,<br>12- Persons admitted to a health or social institution<br>13- Patient on AME (state medical aid)<br> | Patient =18 with SARS Cov 2 pneumonia requiring oxygen administration. <br>MedDRA version: 20.0
Level: LLT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: CAPTOPRIL<br>Pharmaceutical Form: Concentrate for nebuliser solution<br><br> | Main Objective: To demonstrate the efficacy of captopril nebulization addition to standard of care compared to standard of care in term of 14-day ventilation free survival;Timepoint(s) of evaluation of this end point: 14 days;Primary end point(s): 14-day invasive mechanical ventilation free survival: defined as the proportion of patients requiring IMV or dying between randomization and Day 14;Secondary Objective: To demonstrate the efficacy and safety of captopril nebulization:<br>- Efficacy :<br>• Mortality at 28 day<br>• Need of invasive mechanical ventilation (IMV) at 28 days<br>• Length of hospitalization<br>• Length of stay in ICU<br>• Length of mechanical ventilation<br>- Safety :<br>• Respiratory tolerance<br>• Hemodynamic tolerance<br>• Metabolic tolerance<br>• Renal tolerance<br>• Skin tolerance→Timepoint(s) of evaluation of this end point: 14 days;Primary end point(s): 14-day invasive mechanical ventilation free survival: defined as the proportion of patients requiring IMV or dying between randomization and Day 14;Secondary Objective: To demonstrate the efficacy and safety of captopril nebulization:<br>- Efficacy :<br>• Mortality at 28 day<br>• Need of invasive mechanical ventilation (IMV) at 28 days<br>• Length of hospitalization<br>• Length of stay in ICU<br>• Length of mechanical ventilation<br>- Safety :<br>• Respiratory tolerance<br>• Hemodynamic tolerance<br>• Metabolic tolerance<br>• Renal tolerance<br>• Skin tolerance;Main Objective: To demonstrate the efficacy of captopril nebulization addition to standard of care compared to standard of care in term of 14-day ventilation free survival | | | | Yes | False | | |
| EUCTR2020-001766-11-FR | 11 May 2020 | Losartan and spironolactone treatment for COVID-19 patients with acute respiratory failure in intensive care unit | Losartan and spironolactone treatment for COVID-19 patients with acute respiratory failure in intensive care unit - COVIDANCE | | ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE | 15/04/2020 | 20200415 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001766-11 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 29/04/2020 | 90 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: group control
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| France | clinical project manager | | DRS, 80 Rue Brochier | promotion.interne@ap-hm.fr | 0491382183 | ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE | Inclusion criteria: <br>Major patient<br>Patient with respiratory distress requiring oxygen support greater than or equal to 6 liters per minute.<br>News-Score greater than 6<br>PCR SARS-CoV-2 positive in a pharyngeal or respiratory sample,<br>Informed Consent<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 45<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 45<br> | Exclusion criteria: <br>Minor patient,<br>Patient deprived of liberty,<br>Patient's refusal to participate in the study,<br>Patient for whom therapeutic limitation measures have been issued justifying the absence of mechanical ventilation,<br>Patient aged 80 or over,<br>Hypotension justifying treatment with noradrenaline,<br>Acute renal failure with a clearance of less than 60ml / min,<br>Severe liver failure.<br>Intolerance or contraindication to losartan or spironolactone.<br> | Patients with Covid-19;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: LOSARTAN ARROW 50 mg, comprimé pelliculé sécable<br>Product Name: Losartan<br>Product Code: Losartan<br>Pharmaceutical Form: Pillules<br>INN or Proposed INN: LOSARTAN<br>CAS Number: 114798-26-4<br>Current Sponsor code: losartan<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 50-<br><br>Trade Name: SPIRONOLACTONE ARROW 25 mg,<br>comprimé pelliculé sécable<br>Product Name: SPIRONOLACTONE<br>Product Code: SPIRONOLACTONE<br>Pharmaceutical Form: Pillules<br>INN or Proposed INN: SPIRONOLACTONE<br>Current Sponsor code: SPIRONOLACTONE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 25-<br><br> | Timepoint(s) of evaluation of this end point: 7th day post-inclusion;Primary end point(s): Organ failures will be assessed on the SOFA score;Secondary Objective: Show the interest of ARA2 / Spironolactone treatment on organ failures judged on the SOFA score on the 3rd, 14th, 21st, 28th day post-inclusion.<br>Show the interest of ARA2 / Spironolactone treatment on oxygenation based on the PaO2 / FiO2 ratio.<br>Show the interest of ARA2 / Spironolactone treatment for the duration of mechanical ventilation.<br>To show the interest of ARA2 / Spironolactone treatment on mortality.<br>Evaluate the clinical and biological tolerance of these treatments.;Main Objective: To show the interest of treatment with losartan and spironolactone in patients infected with COVID-19 and suffering from acute respiratory distress syndrome on the impact of organ failures judged on the SOFA score on the 7th day post-inclusion | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-001449-38-GB | 11 May 2020 | A Randomised Controlled Trial of Early Intervention in Patients HospItalised with COVID-19: Favipiravir verses HydroxycholorquiNe & Azithromycin & Zinc vErsEs Standard CaRe | A Randomised Controlled Trial of Early Intervention in Patients HospItalised with COVID-19: Favipiravir verses HydroxycholorquiNe & Azithromycin & Zinc vErsEs Standard CaRe - PIONEER | | Chelsea and Westminster Hospital NHS Foundation Trust | 17/04/2020 | 20200417 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001449-38 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 29/04/2020 | 450 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Current UK standard of care for COVID-19 infection
Number of treatment arms in the trial: 3
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| United Kingdom | Research and Development Office | | Unit G2 Harbour Yard, Chelsea Harbour | research.development@chelwest.nhs.uk | 02033156825 | Chelsea and Westminster Hospital NHS Foundation Trust | Inclusion criteria: <br>he participant may enter the study if the following apply:<br>1. Adult participants: Signed informed consent<br>2. New admission to hospital for period expected to last = 1 night<br>3. Suspected or confirmed COVID-19 infection<br>Patients are suspected of COVID-19 infection if they have one of the following:<br>· Influenza like illness (fever =37.8°C and at least one of the following respiratory symptoms, which must be of acute onset: persistent cough, hoarseness, nasal discharge or congestion, shortness of breath, sore throat, wheezing or sneezing).<br>· Acute respiratory distress syndrome<br>· Radiological evidence of pneumonia<br>4. For women to be eligible to enter and participate in the study they should be: of non-child-bearing<br>- potential defined as either post-menopausal (12 months of spontaneous amenorrhea and = 45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or,<br>- or of child-bearing potential have a negative pregnancy test at screening and agrees to remain sexually abstinent or use a method of contraception with a failure rate of < 1% per year as indicated in Appendix B during the treatment and for a period of 7 days after the last dose. Hormonal contraceptive methods must be supplemented by a barrier method.<br>5. Men who are sexually active must use an adequate method of contraception as listed in Appendix B, for a period of at least 7 days after the last dose<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 225<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 225<br> | Exclusion criteria: <br>The participant may not enter the study if ANY of the following apply:<br>1. Pregnant or breast feeding, due to potential teratogenicity<br>2. Hepatic impairment – (AST or ALT > 3.5 x upper limit of normal)<br>3. Renal impairment – (eGFR <10ml/ minute)<br>4. Known history of retinopathy<br>5. Known history of G6PD deficiency <br>6. Known history of Myasthenia gravis<br>7. QT-prolongation (>430ms in males or >450ms in females, calculated as per investigators discretion)<br>8. Presently enrolled in an interventional drug study or on hydroxychloroquine or azithromycin for other therapeutic reasons<br>9. Unable to take medication via the oral or nasogastric route<br>10. Immunocompromised patients (see Appendix C) <br>11. Known sensitivity to Azithromycin (or other macrolide drugs), Hydroxychloroquine, zinc or Favipiravir<br>NB See Section 9.1 for dose reduction guidance for patients with eGFR <50ml/ minute<br><br> | COVID-19 Infection <br>MedDRA version: 20.0
Level: LLT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Favipiravir<br>Pharmaceutical Form: <br>INN or Proposed INN: Favipiravir<br>CAS Number: 259793-96-9<br><br>Product Name: Hydroxychloroquine<br>Pharmaceutical Form: <br>INN or Proposed INN: Hydroxychloroquine<br>CAS Number: 118-42-3<br><br>Product Name: Azithromycin<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: Azithromycin<br>CAS Number: 83905-01-5<br><br> | Main Objective: To determine whether early intervention with either a combination of hydroxychloroquine, azithromycin and zinc or favipirivir improves time to significant improvement in clinical status.;Secondary Objective: To assess whether early intervention with Favipiravir or the combination of Hydroxychloroquine, Zinc and Azithromycin improves mortality in patients with COVID-19 infection<br><br>To determine whether early intervention with Favipiravir or the combination of Hydroxychloroquine, Zinc and Azithromycin reduces resource utilisation in patients with COVID-19 infection <br><br>To explore whether early intervention with Favipiravir or the combination of Hydroxychloroquine, Zinc and Azithromycin attenuates the excessive inflammatory cytokine response in patients with COVID-19 infection<br>;Primary end point(s): Time to clinical improvement (post randomisation) by two points on a seven-category ordinal scale or live discharge from the hospital, whichever comes first <br>The seven-category ordinal scale:<br>1: Not hospitalised with resumption of normal activities<br>2: Not hospitalised, but unable to resume normal <br>3: Hospitalised, not requiring supplemental oxygen<br>4: Hospitalised, requiring supplemental oxygen<br>5: Hospitalised, requiring nasal high-flow oxygen therapy, non-invasive mechanical ventilation or both<br>6: Hospitalised, requiring ECMO (Extra-corporal membrane oxygenation), invasive mechanical ventilation or both<br>7: Death<br>;Timepoint(s) of evaluation of this end point: Data for assessment of primary endpoint will be collected until discharge from inpatient care, 28 day from enrolment or death. | | | | Yes | True | parent | |
| → | EUCTR2020-001786-36-GB | 11 May 2020 | Study of investigational medicinal product of CYT107 in patients with COVID-19 infection who have low number of lymphocytes in their blood (ILIAD 7 trial) | Recombinant InterLeukin-7 (CYT107) to Improve clinical outcomes in lymphopenic pAtients with COVID-19 infection “ILIAD 7 trial” - ILIAD | | RevImmune SAS France | 15/04/2020 | 20200415 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001786-36 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 06/05/2020 | 200 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United States;France;Spain;Belgium;Italy;United Kingdom | Michel Morre | | 15 rue Taitbout | mmorre@revimmune.com | 33603357060 | RevImmune SAS France | Inclusion criteria: <br>1. A written, signed informed consent, or emergency oral consent, by the patient or the patient’s legally authorized representative, and the anticipated ability for participant to be re-consented in the future for ongoing Study participation <br>2. Men and women aged = 25 – 80 (included) years of age <br>3. Hospitalized patients with two absolute lymphocyte count (ALC) = 700 cells/mm3, at two time points at least 24 hours apart, following HOSPITALIZATION: <br>The FIRST time point should not be performed earlier than 48 hours after Hospitalization, thus first test dose can’t be administered before 72 hours after hospitalization (From this time point the investigator may choose to further postpone the commencement of IL-7 (CYT107) treatment according to patient’s clinical status) <br>4. Hospitalized patients with moderate to severe hypoxemia requiring oxygen therapy at >4L per minute nasal cannula or greater to keep saturations >90%, non-invasive positive pressure ventilation (e.g., BIPAP), or patients intubated/ventilated for respiratory failure <br>5. Confirmed infection with COVID-19 by any acceptable test available/utilized at each site <br>6. Patient with medical insurance or government support <br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 38<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 10<br> | Exclusion criteria: <br>1. Pregnancy or breast feeding;<br>2. Refusal or inability to practice contraception regardless of the gender of the patient;<br>3. ALT and/or AST > 5 x ULN<br>4. Known, active auto-immune disease;<br>5. Ongoing cancer treatment with chemotherapy / immunotherapy or any cancer therapy within last 3 months and/or ongoing;<br>6. Patients with past history of Solid Organ transplant.<br>7. Active tuberculosis, uncontrolled active HBV or HCV infection, HIV with positive viral load.<br>8. Hospitalized patients with refractory hypoxia, defined as inability to maintain saturation >85% with maximal available therapy for >6 hours<br>9. Patients receiving any agent with immune suppressive effects, other than steroids at dosages less than 300mg/day and/or anti-IL6 treatments like Tocilizumab or Sarilumab which should preferably be minimized<br>10. Patients with baseline Rockwood Clinical Frailty Scale = 6.<br>11. Patients under guardianship<br> | Lymphopenia and T cell exhaustion in COVID-19 patients;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: CYT107 <br>Pharmaceutical Form: Solution for injection<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intramuscular use<br><br> | Timepoint(s) of evaluation of this end point: Day -1, 0, 1, 3, 6/7*, 9/10/11*, 12-18*, 21, 30/Hospital discharge *Day for drug administration per PI discretion with 5 doses to be administered over approx. 2 weeks;Primary end point(s): An improvement in the absolute lymphocyte count (ALC) is defined as a statistically significant increase from randomization to day 30 or HD, and will also be assessed at defined timepoints (as indicated in the Schedule of Activities, to include all Study drug administration days).;Secondary Objective: a) To obtain “clinical improvement” as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD<br>b) To determine if CYT107 will lead to a significant decline of SARS-CoV-2 viral load through day 30 or HD <br>c) To compare the incidence of grade 3-4 adverse events for CYT107 versus placebo through day 45 <br>d) To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45 <br>e) To compare the effect of CYT107 versus placebo on the length of hospitalization <br>f) To compare the effect of CYT107 versus placebo on the length of stay in ICU <br>g) To compare the effect of CYT107 versus placebo on readmissions to ICU <br>h) To compare the effect of CYT107 versus placebo on organ support free days <br>i) To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45 <br>j) To assess the impact of CYT107 on all-cause mortality through day 45 <br> AND objectives k, l, m and n <br><br>;Main Objective: The primary objective of the Study is to improve the absolute lymphocyte count (ALC) of lymphopenic (ALC=700/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever comes first.→Main Objective: The primary objective of the Study is to improve the absolute lymphocyte count (ALC) of lymphopenic (ALC=700/mm3) COVID-19 infected participants out to approximately 30 days following initial Study drug administration or Hospital discharge (HD), whichever comes first.;Secondary Objective: a) To obtain “clinical improvement” as defined by a 2 points improvement in a 7-point ordinal scale for Clinical Assessment, through day 30 or HD<br>b) To determine if CYT107 will lead to a significant decline of SARS-CoV-2 viral load through day 30 or HD <br>c) To compare the incidence of grade 3-4 adverse events for CYT107 versus placebo through day 45 <br>d) To compare the effect of CYT107 versus placebo on the frequency of secondary infections through day 45 <br>e) To compare the effect of CYT107 versus placebo on the length of hospitalization <br>f) To compare the effect of CYT107 versus placebo on the length of stay in ICU <br>g) To compare the effect of CYT107 versus placebo on readmissions to ICU <br>h) To compare the effect of CYT107 versus placebo on organ support free days <br>i) To compare the effect of CYT107 versus placebo on the frequency of re-hospitalization through day 45 <br>j) To assess the impact of CYT107 on all-cause mortality through day 45 <br> AND objectives k, l, m and n <br><br>;Primary end point(s): An improvement in the absolute lymphocyte count (ALC) is defined as a statistically significant increase from randomization to day 30 or HD, and will also be assessed at defined timepoints (as indicated in the Schedule of Activities, to include all Study drug administration days).;Timepoint(s) of evaluation of this end point: Day -1, 0, 1, 3, 6/7*, 9/10/11*, 12-18*, 21, 30/Hospital discharge *Day for drug administration per PI discretion with 5 doses to be administered over approx. 2 weeks | | | | Yes | False | | |
| EUCTR2020-001721-31-GB | 11 May 2020 | Sinus-Wash Pilot Study | Can a sinus rinse and mouth wash reduce viral load in COVID-19 positive individuals? - SINUS WASH pilot study | | Hampshire Hospitals NHS TRust | 27/04/2020 | 20200427 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001721-31 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 01/05/2020 | 40 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United Kingdom | Chief Investigator | | Aldermaston Road | afroze.khan@nhs.net | 07885903693 | Hampshire Hospitals NHS TRust | Inclusion criteria: <br>Staff who have tested positive for COVID -19 AND in isolation at home.<br>Patients who have been tested positive for Covid-19 on general wards or about to be discharged who are well enough to self administer nasal washes.<br>Household member of affected staff member and household members of affected patients on general ward once discharged to home self-isolation<br>18 years and over<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 50<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 10<br> | Exclusion criteria: <br>Known hypersensitivity to Iodine<br>Those at risk of aspiration due to unsafe swallow<br>Those unable to perform treatment themselves<br>Under 18 years of age <br><br> | Covid-19 <br>MedDRA version: 20.0
Level: LLT
Classification code 10061986
Term: SARS
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Vedine/Betadine<br>Product Name: Vedine/Betadine<br>Pharmaceutical Form: Oromucosal solution<br>INN or Proposed INN: iodonated Povidone<br>CAS Number: 9003-39-8<br>Current Sponsor code: nil<br>Other descriptive name: betadine/videne<br>Concentration unit: % (V/V) percent volume/volume<br>Concentration type: equal<br>Concentration number: 10-<br>Pharmaceutical form of the placebo: Nasal wash<br>Route of administration of the placebo: Nasal use<br><br> | Timepoint(s) of evaluation of this end point: Day 0,2,4,7 and 14 of trial period via oral and nasopharyngeal swabs ;Primary end point(s): The primary outcome measure will be the change in Viral load in the two arms as measured by real time PCR.;Secondary Objective: Does Povidine-Iodine as a nose rinse/mouthwash reduce transmission of the virus to co-residents?<br><br>Does Povidine-Iodine reduce the symptom severity in postive individuals as reported by self reported questionnaire via smart phone app?<br><br>;Main Objective: Does Povidine-Iodine reduce the amount of virus in the nose and throat when applied via a sinus rinse/mouth wash? | | | | Yes | False | | |
| → | EUCTR2020-001783-28-HU | 11 May 2020 | BCG vaccination against COVID-19 infection in Hungary | REDUCING ABSENCE FROM WORK OF HEALTHCARE WORKERS DUE TO COVID-19 INFECTION BY BCG (BACILLUS CALMETTE-GUÉRIN) VACCINATION - BACH (BCG Against COVID-19 in Hunga | | National Korányi Institute of Pulmonology | 29/04/2020 | 20200429 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001783-28 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 06/05/2020 | 1000 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Hungary | Directorate | | Korányi Frigyes út 1. | igazgatosag@koranyi.hu | +3613913200 | National Korányi Institute of Pulmonology | Inclusion criteria: <br>In order to be eligible to participate in this study, a subject must meet the following criteria:<br>• Adult (>18 years) <br>• Healthcare worker with direct contact with COVID-19 positive patients<br>• Written informed consent<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 950<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 50<br> | Exclusion criteria: <br>A potential subject who meets any of the following criteria will be excluded from participation in this study:<br>• Fever (>37,5 ºC) within the past 24 hours <br>• Suspicion of current active viral or bacterial infection <br>• Expected vaccination during the study period, independently of the type of vaccination.<br>• Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks <br>• Active solid or non-solid malignancy or lymphoma within the prior two years<br>• Active participation in another research study that involves BCG administration<br><br> | healthy volunteers working in the healthcare treating patients with new type of coronavirus (SARS-CoV-2) infection;Therapeutic area: Not possible to specify | <br>Trade Name: SSI BCG powder and solvent for suspension for injection<br>Product Name: BCG vaccine (Danish strain 1331, SSI, Denmark)<br>Product Code: OGYI-T-9001/02<br>Pharmaceutical Form: Suspension for injection<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intradermal use<br><br> | Timepoint(s) of evaluation of this end point: End of study;Primary end point(s): Primary End Point (repeat as necessary) Number of days of unplanned absenteeism because of documented COVID-19 infection ;Secondary Objective: Secondary objectives: To reduce COVID-19 infection, hospital admission, ICU admission, or death in healthcare workers with direct COVID-19 positive patient contacts during the epidemic phase of COVID-19;Main Objective: To reduce absenteeism among healthcare workers with direct COVID-19 positive patient contacts during the epidemic phase of COVID-19. →Secondary Objective: Secondary objectives: To reduce COVID-19 infection, hospital admission, ICU admission, or death in healthcare workers with direct COVID-19 positive patient contacts during the epidemic phase of COVID-19;Primary end point(s): Primary End Point (repeat as necessary) Number of days of unplanned absenteeism because of documented COVID-19 infection ;Timepoint(s) of evaluation of this end point: End of study;Main Objective: To reduce absenteeism among healthcare workers with direct COVID-19 positive patient contacts during the epidemic phase of COVID-19. | | | | Yes | False | | |
| EUCTR2020-001882-36-GR | 11 May 2020 | CLARITHROMYCIN IN COVID-19 | ANTI-INFLAMMATORY CLARITHROMYCIN TO IMPROVE SARS-CoV-2 (COVID-19) INFECTION EARLY: THE ACHIEVE OPEN-LABEL NON-RANDOMIZED CLINICAL TRIAL | | Hellenic Institute for the Study of Sepsis | 30/04/2020 | 20200430 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001882-36 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 07/05/2020 | 90 | Interventional clinical trial of medicinal product | Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Greece | President of the Board | | 88 Michalakopoulou Street | insepsis@otenet.gr | +302107480662 | Hellenic Institute for the Study of Sepsis | Inclusion criteria: <br>• Age =18 years<br>• Male of female gender<br>• Written informed consent provided by the patients or by a first-degree relative in case of patients unable to consent<br>• In case of women, unwillingness to remain pregnant during the study period achieved either by their partner using condom or by themselves using oral contraceptives.<br>• Confirmed infection by SARS-CoV-2 virus <br>• Infection of the upper respiratory tract or of the lower respiratory tract<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 45<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 45<br> | Exclusion criteria: <br>• Age below 18 years<br>• Denial of written informed consent<br>• Presence of severe respiratory failure<br>• Intake of any macrolide for the current episode of infection under study<br>• Intake of hydroxychloroquine or chloroquine phosphate.<br>• Oral or intravenous intake of corticosteroids defined as any more than 0.4mg/kg daily intake of equivalent prednisone for the last 3 days<br>• Neutropenia defined as an absolute neutrophil count below 1,000/mm3<br>• Presence of any contraindications for the study drugs as stated in local label information<br>• QTc interval at rest ECG =500 msec or history of known congenital long QT syndrome<br>• Pregnancy or lactation<br> | Management of infection by SARS-CoV-2 (COVID-19) <br>MedDRA version: 20.0
Level: LLT
Classification code 10035738
Term: Pneumonia viral NOS
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Klaricid<br>Product Name: Clarithromycin<br>Pharmaceutical Form: Tablet<br><br> | Timepoint(s) of evaluation of this end point: Day 8;Primary end point(s): This is defined on day 8 (EOT visit). This is a composite score since it is defined differently for patients with upper respiratory tract infection or lower respiratory tract infection by SARS-CoV-2.<br>• For patients with an upper respiratory tract infection this is defined as no need for hospital admission in case of earlier discharge or as lack of progression into lower respiratory tract infection.<br>• For patients with a lower respiratory tract infection this is defined as at least 50% decrease of the score of respiratory symptoms from the baseline. This score is the sum of scoring for the symptoms of cough, dyspnea, purulent sputum expectoration and pleuritic chest pain.<br>Patients who develop by day 8 severe respiratory failure do not meet the study primary endpoint;Secondary Objective: Not applicable;Main Objective: Recent information appearing from different countries suggest that treatment of Covid-19 with hydroxychloroquine or with a combination of hydroxychloroquine and azithromycin has either an indifferent effect on viral replication or substantial cardiotoxicity. This is a clinical trial aiming to prove that addition of oral clarithromycin to treatment regimen of Covid-19 is associated with early clinical improvement and attenuation of the high inflammatory burden of the host. The study will not comprise a placebo-comparator group since this is considered inappropriate in an era of a pandemic with substantial global mortality. | | | | Yes | False | | |
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| IRCT20160313027033N2 | 18 May 2020 | The effect of MCT Oil on COVID-19 | Evaluation of the effect of oral intermediate chain triglyceride on prognosis and course of disease in suspected outpatients with COVID-19 | | Kerman University of Medical Sciences | 2020-04-16 | 20200416 | IRCT | http://en.irct.ir/trial/46762 | Not Recruiting | No | 18 years | 65 years | Both | 2020-04-02 | 120 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were randomly divided into intervention and control groups using Random Allocation Software. | N/A | Iran (Islamic Republic of) | Alireza Zahedi Neyestani | | Crossroad Amirkabir, Jomhuri eslami Blvd | ali.zahedi@kmu.ac.ir | +98 34 3132 5856 | Kerman University of Medical Sciences | Inclusion criteria: Patients with mild or moderate COVID-19 disease according to the diagnostic protocol provided by the Ministry of Health | Exclusion criteria: No allergic to MCT (for those who have previously taken MCT and know they are allergic). | Coronavirus COVID-19. <br>COVID-19;U07.1 | Intervention 1: Intervention group: Patients in this group in addition to drug treatment according to the Ministry of Health protocol, take 2 tablespoons of medium-chain triglyceride (MCT) to cure fever with each meal. Both group are thought to take the following advice base on traditional medicine instructions:During this period, avoid consuming carbohydrate including sweet and eat less starch food.skim snacks and start eating when they're starving.avoid eating before satiating.eat slowly and chew well.walk for 15 minutes after eating. Intervention 2: Control group: Patients in this group receive medication according to the Ministry of Health protocol. Both group are thought to take the following advice base on traditional medicine instructions:During this period, avoid consuming carbohydrate including sweet and eat less starch food.skim snacks and start eating when they're starving.avoid eating before satiating.eat slowly and chew well.walk for 15 minutes after eating. | Urine Ketone. Timepoint: Four hours after taking MCT oil. Method of measurement: It is checked with a urine test strip.;Muscular pain. Timepoint: 0-1-2-3-14 days after starting intervention. Method of measurement: Asking patients using visual analog scale (VAS).;Respiratory rate. Timepoint: 0-1-2-3-14 days after starting intervention. Method of measurement: Counting the number of breaths per minute.;Weakness. Timepoint: 0-1-2-3-14 days after starting intervention. Method of measurement: Asking patients using visual analog scale (VAS).;Cough (severity-frequency). Timepoint: 0-1-2-3-14 days after starting intervention. Method of measurement: Fisman Cough Severity Score.;Temperature. Timepoint: 0-1-2-3-14 days after starting intervention. Method of measurement: Thermometer. | | | | No | False | | |
| → | IRCT20180712040449N2 | 18 May 2020 | Effect of oral multi-herbal preparation on COVID-19 | Formulation and evaluation of their efficacy of herbal capsule and decoction in patients with COVID-19 via a randomized clinical trial. | | Tehran University of Medical Sciences | 2020-04-01 | 20200401 | IRCT | http://en.irct.ir/trial/46782 | Recruiting | No | 18 years | 75 years | Both | 2020-03-23 | 68 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: To randomly assign the patients to two groups of treatment and placebo by a third person and using a computer program with simple randomization method, the random sample number is generated and each patient will be assigned a number. | 3 | Iran (Islamic Republic of);Iran (Islamic Republic of);Iran (Islamic Republic of) | Mehrdad Karimi | | No. 27, Sarparast Ave, Taleghani Ave, Tehran, School of Persian medicine | mehrdadkarimi@yahoo.com | +98 21 8897 6527 | Tehran University of Medical Sciences | Inclusion criteria: Patients with one or more of the following symptoms in addition to acute respiratory disease (ARI):• RR> 30• PO2 <93%• Pulmonary infiltration in chest x-ray• Clinical judgment of a specialist<br>Age range of 18 to 75 years in both genders<br>Lack of any serious concomitant disease of the heart, brain, or lungs, metabolic disorders, and etc.<br>The patient’s ability and own will to fill out a personal consent form for inclusion in the study<br>Patient not intubated. | Exclusion criteria: Pregnancy and lactation<br>Any history of allergy to any of the herbal product components<br>Inability to take a drug per-oral<br>Any condition that precludes continuance of medical intervention based on the judgment of a physician.<br>Need for intubation<br>Nausea and vomiting and oral intolerance<br>Resistant hypoxemia<br>Reduced level of consciousness<br>Hemodynamic instability<br>Hypercapnia - respiratory fatigue<br>Any manifestation of known side effects of any of the herbal product components | COVID-19. <br>Covid-19;U07.1 | Intervention 1: Intervention group: 34 patients receive herbal treatment including 150 ml of decoction (Matricaria chamomilla L., Zataria multiflora Boiss., Glycyrrhiza glabra L., Ziziphus jujuba Mill., Ficus carica L., Urtica dioica L., Althaea officinalis L., Hyssopus officinali L.) 3 times a day and capsule (Lyophilized powder from hydroalcoholic 70% extracts of Punica granatum L., Rheum palmatum L. and seed powder of Nigella sativa L.) 2 times a day with routine interventions based on the instructions of the Ministry of Health for 2 weeks. Intervention 2: Control group:34 patients receive routine interventions according to the instructions of the Ministry of Health for 2 weeks. | O2 saturation percentage. Timepoint: Clinical examination and pulse oximetry at baseline, days 3, 6, 9, 12 and 14. Method of measurement: Pulse Oximeter.;Lung inflammation. Timepoint: CT scan at baseline, days 7 and 14. Method of measurement: CT scan.→Lung inflammation. Timepoint: CT scan at baseline, days 7 and 14. Method of measurement: CT scan.;O2 saturation percentage. Timepoint: Clinical examination and pulse oximetry at baseline, days 3, 6, 9, 12 and 14. Method of measurement: Pulse Oximeter. | | | | No | False | | |
| IRCT20130812014333N145 | 18 May 2020 | Comparative assessment of the efficacy and safety of add ontreatment with “Sofosbuvir standard of care therapeutic regimenVelpatasvir” to “standard of caretherapeutic regimen” in patients with COVID-19 | Comparative assessment of the efficacy and safety of add ontreatment with “Sofosbuvir plus Velpatasvir” to “standard of care therapeutic regimen” in patients with COVID-19 | | Kermanshah University of Medical Sciences | 2020-03-30 | 20200330 | IRCT | http://en.irct.ir/trial/46790 | Recruiting | No | 18 years | no limit | Both | 2020-04-08 | 80 | interventional | Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the random number table, patients are divided into two groups of 40. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 0, 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7, 9 will be assigned to the control group, Blinding description: In this study, patients will be kept blind to the type of treatment. | 3 | Iran (Islamic Republic of) | Dr. Reza Khodarahmi | | School of Pharmacy, Nursing Boulevard | rkhodarahmi@mbrc.ac.ir | +98 83 3426 6780 | Kermanshah University of Medical Sciences | Inclusion criteria: Age over 18 years<br>Absolute lymphocyte count <1100 / ML or SaO2 <93 | Exclusion criteria: Pregnancy or breast-feeding<br>The physician's decision that the trial is not in the patient's interest<br>Any circumstances that do not allow to follow the treatment protocol easily<br>A history of severe liver disease including cirrhosis or ALT or AST levels more than fives times normal<br>Drugs that are contraindicated with standard treatment or Sofosbuvir-Velpatasvir and cannot be discontinued<br>History of untreated HIV infection or hepatitis C | COVID-19. <br>COVID-19 disease;U07.1 | Intervention 1: The intervention group in addition to standard treatment (400 mg of hydroxychloroquine and 100 to 400 mg of Lupinavir-ritonavir at a time), will receive 100 to 400 mg of Sofosbuvir-Velpatasvir for 10 days. Intervention 2: The control group will receive standard treatment including 400 mg of hydroxychloroquine and 100 to 400 mg of lupinavir-ritonavir for 10 days at a time. | Clinical status. Timepoint: Beginning of the study, 10 days later, or discharge time. Method of measurement: By a doctor. | | | | Yes | False | | |
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| EUCTR2020-001886-35-GB | 25 May 2020 | A Clinical Trial of Nebulized Bovactant (Alveofact ®) for the Treatment of Moderate to Severe COVID-19 | A clinical trial of nebulized surfactant for the Treatment of moderate to severe COVID-19 in adults - COVID-19 Surfactant Clinical Trial | | University Hospital Southampton NHS Foundation Trust | 11/05/2020 | 20200511 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001886-35 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 15/05/2020 | 20 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Standard care<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United Kingdom | Mike Grocott | | Southampton General Hospital, Tremona Road | mike.grocott@soton.ac.uk | 02381208449 | University Hospital Southampton NHS Foundation Trust | Inclusion criteria: <br>1. Age =18 years old<br>2. Confirmed COVID-19 positive by PCR<br>3. Within 24 hours of mechanical ventilation <br>4. Assent obtained from personnel (PerLR) or professional legal representative (ProfLR) <br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 10<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 10<br> | Exclusion criteria: <br>1. Imminent expected death within 24 hours<br>2. Specific contraindications to surfactant administration (e.g. known allergy, pneumothorax, pulmonary haemorrhage)<br>3. Known or suspected pregnancy<br>4. Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR < 30)<br>5. Liver failure (Child-Pugh Class C)<br>6. Anticipated transfer to another hospital, which is not a study site within 72 hours.<br>7. Current participation or participation in another study within the last month that in the opinion of the investigator would prevent enrollment for safety purposes.<br>8. Consent declined<br><br><br> | COVID-19 infection in patients requiring endotrachael intubation <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Alveofact®<br>Product Name: Alveofact®<br>Pharmaceutical Form: Powder for nebuliser suspension<br>INN or Proposed INN: SF-RI 1<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 45-<br><br> | Timepoint(s) of evaluation of this end point: 48 hours after study initiation;Primary end point(s): <br>Change in PaO2/FiO2 ratio at 48 hours after study initiation.<br><br>Change in the Ventilation Index at 48 hours after study initiation.;Secondary Objective: To assess the safety of surfactant therapy via the modified Aerogen nebuliser and mean clinical improvement of patients with COVID-19 following administration.;Main Objective: To assess whether administration of surfactant therapy via the modified Aerogen nebuliser results in improved PaO2/FiO2 ratio and ventilation index in patients with COVID-19 after last dose of surfactant and the optimal dosing schedule to be used. | | | | Yes | False | | |
| → | EUCTR2020-001614-38-BE | 25 May 2020 | Covid-19: A randomized, open-label, adaptive, proof-of- concept clinical trial of new antiviral drug candidates against SARS-CoV-2. | Covid-19: A randomized, open-label, adaptive, proof-of- concept clinical trial of new antiviral drug candidates against SARS-CoV-2. - Antivirals for COVID-19 DAWN AZITHRO | | UZLeuven | 06/04/2020 | 20200406 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001614-38 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 22/04/2020 | 282 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Best clinical practice<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Belgium | clinical trial center UZ Leuven | | Herestraat 49 | ctc@uzleuven.be | | UZ Leuven | Inclusion criteria: <br>1. Subject (=18 years old) or legally authorized representative provides informed consent prior to initiation of any study procedures. When signed informed consent is not possible (e.g. due to restrictions to prevent viral transmission), verbal informed consent in the presence of a witness not related to the investigational research study will be obtained.
<br>2. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
<br>3. Male or non-pregnant female adult =18 years of age at time of enrolment.
<br>4. Has a confirmed diagnosis of SARS-CoV-2 infection within 72 hours prior to randomization, defined as either:
<br>a. laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen or
<br>b. The combination of upper or lower respiratory infection symptoms (fever, cough, dyspnea, desaturation) and typical findings on chest CT scan and absence of other plausible diagnoses
<br>5. Illness of any duration, and at least one of the following:
<br>a. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or
<br>b. Clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% on room air, or
<br>c. Requiring mechanical ventilation and/or supplemental oxygen. <br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 141<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 141<br> | Exclusion criteria: <br>1. ALT/AST > 5 times the upper limit of normal.
<br>2. Pregnancy or breast feeding.
<br>3. Allergy to any study medication
<br>4. Any medical condition which would impose an unacceptable safety hazard by participation to the study.
<br>5. Study drug specific exclusion criteria:
<br>*for Azithromycin :
<br>o heart failure with severely reduced ejection fraction (30%)
<br>o known prolonged long QT interval on ECG (> 470 msec males and > 480 females with Fridericia criteria; for patients with ventricular conduction delay the use of Rautaharju formula is also allowed )
<br>o patients on Macrolides during the last week before admission
<br>*For other treatment strata, see arm-specific protocols.
<br><br> | COVID-19 <br>MedDRA version: 20.0
Level: LLT
Classification code 10038700
Term: Respiratory infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: azithromycine<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: AZITHROMYCIN DIHYDRATE<br>CAS Number: 117772-70-0<br><br>Trade Name: azithromycine<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: AZITHROMYCIN DIHYDRATE<br>CAS Number: 117772-70-0<br><br>Trade Name: azithromycine<br>Pharmaceutical Form: Syrup<br>INN or Proposed INN: AZITHROMYCIN DIHYDRATE<br>CAS Number: 117772-70-0<br><br> | Timepoint(s) of evaluation of this end point: Day 15;Primary end point(s): Clinical status of subject at day 15 (on a 7-point ordinal scale): <br>1. Not hospitalized, no limitations on activities <br>2. Not hospitalized, limitation on activities; <br>3. Hospitalized, not requiring supplemental oxygen; <br>4. Hospitalized, requiring supplemental oxygen; <br>5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; <br>6. Hospitalized, on invasive mechanical ventilation or ECMO; <br>7. Death.<br><br>Primary outcome will be time from Day 0 to sustained clinical improvement or life discharge, whichever comes first, whereby a sustained clinical improvement is defined as an improvement of = 2 points vs the highest value of Day 0 and 1 and sustained for at least 3 days.;Secondary Objective: To evaluate clinical efficacy of Azithromycine as compared to the control arm as assessed by Clinical Severity, Oxygenation, Mechanical Ventilation, Hospitalisation, Mortality and Evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm as assessed by <br>o Cumulative incidence of serious adverse events (SAEs) and adverse events (AEs) graded as grade 4 or 5. <br>o Discontinuation or temporary suspension of drug administration (for any reason). <br>o Changes in white cell count, haemoglobin, platelets, creatinine, glucose, total bilirubin, ALT, and AST over time. ;Main Objective: The overall objective of the study is to evaluate the clinical efficacy and safety of Azithromycine relative to the standard of care in patients hospitalized with COVID-19.→Main Objective: The overall objective of the study is to evaluate the clinical efficacy and safety of Azithromycine relative to the standard of care in patients hospitalized with COVID-19.;Secondary Objective: To evaluate clinical efficacy of Azithromycine as compared to the control arm as assessed by Clinical Severity, Oxygenation, Mechanical Ventilation, Hospitalisation, Mortality and Evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm as assessed by <br>o Cumulative incidence of serious adverse events (SAEs) and adverse events (AEs) graded as grade 4 or 5. <br>o Discontinuation or temporary suspension of drug administration (for any reason). <br>o Changes in white cell count, haemoglobin, platelets, creatinine, glucose, total bilirubin, ALT, and AST over time. ;Primary end point(s): Clinical status of subject at day 15 (on a 7-point ordinal scale): <br>1. Not hospitalized, no limitations on activities <br>2. Not hospitalized, limitation on activities; <br>3. Hospitalized, not requiring supplemental oxygen; <br>4. Hospitalized, requiring supplemental oxygen; <br>5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; <br>6. Hospitalized, on invasive mechanical ventilation or ECMO; <br>7. Death.<br><br>Primary outcome will be time from Day 0 to sustained clinical improvement or life discharge, whichever comes first, whereby a sustained clinical improvement is defined as an improvement of = 2 points vs the highest value of Day 0 and 1 and sustained for at least 3 days.;Timepoint(s) of evaluation of this end point: Day 15 | | | | Yes | False | | |
| NCT04404634 | 1 June 2020 | Convalescent Plasma To Limit COVID-19 Associated Complications | Convalescent Plasma To Limit COVID-19 Associated Complications: A Randomized Blinded Phase 2 Study Comparing the Efficacy and Safety of Anti-SARS-CoV-2 Plasma To Placebo in COVID-19 Hospitalized Patients | | Yale University | 22/05/2020 | 20200522 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04404634 | Not recruiting | No | 18 Years | N/A | All | May 2020 | 300 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | | | Mahalia Desruisseaux, MD | | mahalia.desruisseaux@yale.edu | 203-737-4057 | |
<br> Inclusion Criteria:
<br>
<br> 1. Patients =18 years of age
<br>
<br> 2. Hospitalized with COVID-19 with respiratory symptoms, cough, chest pain, shortness of
<br> breath, fever, or oxygen saturation = 94%, or abnormal imaging
<br>
<br> 3. Hospitalized for less than 72 hours OR within day 3 to 7 days from first signs of
<br> illness
<br>
<br> 4. Laboratory confirmed COVID-19
<br>
<br> 5. On supplemental oxygen, non-invasive ventilation or high-flow oxygen
<br>
<br> 6. Patients may be on other randomized controlled trials of pharmaceuticals for COVID
<br>
<br> - 19 and patients who meet eligibility criteria will not be excluded on this basis.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Receipt of pooled immunoglobulin in past 30 days
<br>
<br> 2. Contraindication to transfusion or history of prior reactions to transfusion blood
<br> products
<br>
<br> 3. Invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
<br>
<br> 4. Volume overload secondary to congestive heart failure or renal failure
<br>
<br> 5. Intracranial bleed
<br> | | Corona Virus Infection | Biological: Convalescent Plasma;Biological: Lactated Ringer's Solution or Sterile Saline | Clinical Status at 14 days | | | | Yes | False | | |
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| IRCT20200428047228N2 | 15 June 2020 | Hydroxychloroquine in comparison with hydroxychloroquine + azithromycin in patients with covid-19 | Evaluation of the efficiency of hydroxychloroquine drug regimen in comparison with hydroxychloroquine + azithromycin in hospitalized patients with covid-19 in the intensive care unit | | Quality Improvement of Intensive Care Research Center- Shahid Beheshti University | 2020-06-10 | 20200610 | IRCT | http://en.irct.ir/trial/48096 | Recruiting | No | 16 years | 100 years | Both | 2020-05-19 | 40 | interventional |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization, Random Number Table
The numbers will be assigned to the participants who have the inclusion criteria to enter the study, respectively, and according to the table of random numbers, the participants will be divided into two groups of intervention and control, Blinding description: Participants, health care personnel and evaluators of the final outcome are unaware of the drug and placebo given to the intervention and control group .
| 3 | Iran (Islamic Republic of) | Dr. Mohammad Fathi | | Shahid Modarres Hospital, Saadat abad, Tehran, Iran | m.fathi@sbmu.ac.ir | +98 21 2351 5366 | Shahid Beheshti University of Medical Sciences | Inclusion criteria: <br> Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19<br> Requiring hospitalization on the basis of level of consciousness,blood pressure, kidney and liver failure<br> Patient's age between 16 and 100 years<br> Signed informed consent form<br> | Exclusion criteria: <br> Chronic liver and kidney failure<br> HIV patients<br> pregnancy and breast feeding<br> QT interval more than 500 milliseconds<br> | COVID-19. <br>U07.1 - COVID-19;COVID-19 | Intervention 1: Intervention group: hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to seventh day and concurrent, Azithromycin at a dose of 500 mg on the first day and then 250 mg daily until the seventh day . The two groups will receive standard treatment. Intervention 2: Control group: hydroxychloroquine, 400 mg BD on the first day and 200 mg hydroxychloroquine BD daily on the second to seventh day. Increasing the duration of treatment to 10 days, according to the doctor's order. The control group will receive placebo instead of Azithromycin. | Length of stay in the intensive care unit. Timepoint: Once (when discharged from intensive care unit). Method of measurement: Hospital records.;In-hopital mortality. Timepoint: once. Method of measurement: Medical records. | | | | No | False | | |
| → | IRCT20080901001165N60 | 15 June 2020 | Investigating the efficacy of Provita Capsule in controlling the symptoms of patients with COVID-19 | Investigating the efficacy of Provita Capsule in controlling the symptoms of patients with COVID-19 | | Bagheiat-allah University of Medical Sciences | 2020-05-28 | 20200528 | IRCT | http://en.irct.ir/trial/48102 | Recruiting | No | 18 years | 65 years | Both | 2020-05-14 | 30 | interventional |
Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method is used to randomized the patients.
For randomization, we visited the www.sealedenvelope.com, then randomization tab and make a list option were selected, the number of intervention groups, sample size, block size (which was selected due to the small sample size, 4 )were entered the intended locations, then a random list containing the pattern of patient allocation was obtained in two intervention, Blinding description: this is a double-blinded clinical trial, in which, a completely similar placebo to the drug is given to the main researcher by the manufacturer, and the drug and the placebo are distinguished only by the code that only the original researcher knows about.
The doctor and the patient will be unaware of the drug/placebo product.
The results wi | 3 | Iran (Islamic Republic of) | Seyed Hasan Saadat | | Baqiyatallah University of Medical Science, south Sheikh-Bahaei St., Mollasadra St., Vanak Sq., Tehran, Iran. | saadat350@gmail.com | +98 21 8245 5393 | Bagheiat-allah University of Medical Sciences | Inclusion criteria: <br> Age: equal or more than 18 years;<br> The patient have written consciously and freely consent to participate in the study;<br> The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.<br> Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.<br> Less than 7 days have passed since the onset of symptoms.<br> | Exclusion criteria: <br> History of allergy to the ingredients;<br> The patient is in another clinical trial at the same time;<br> The patient needs to receive medical care from the intensive care unit;<br> Pregnancy;<br> Lactation.<br> Impossibility of oral nutrition;<br> | COVID-19. <br>Covid-19;U07.1 | Intervention 1: Intervention group: Provita Capsule (each capsule contain vitamin A, E, D, C, B family, Zn, Se, Para-biotic, and inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran) 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Intervention 2: Control group: Placebo Capsule(contain inactive ingredients similar to Provita's inactive ingredients, produced by Tak-Gen-Zist pharmaceutical company, Iran), 1 capsule, every 12 hours, for 21 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus.). | Clinical symptoms (fever). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Thermometer.;Clinical symptoms (respiratory distress). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Pulse-oxymetery device.;Clinical symptoms (dry cough). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Physical examination,questionnaire.→Clinical symptoms (dry cough). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Physical examination,questionnaire.;Clinical symptoms (respiratory distress). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Pulse-oxymetery device.;Clinical symptoms (fever). Timepoint: Daily monitoring at the hospitalization, but the result of baseline (before the initiation of intervention), and day 7 and day 21 from the initiation, is recorded. Method of measurement: Thermometer. | | | | No | False | | |
| IRCT20080901001165N56 | 15 June 2020 | Evaluation efficacy of "Curcumin and Resveratrol" capsule in controlling symptoms in patients with COVID-19 | Evaluation efficacy of "Curcumin and Resveratrol" capsule in controlling symptoms in patients with COVID-19 | | Bagheiat-allah University of Medical Sciences | 2020-05-23 | 20200523 | IRCT | http://en.irct.ir/trial/48116 | Recruiting | No | 18 years | no limit | Both | 2020-05-16 | 60 | interventional |
Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block Randomization method is used to randomized the patients.
In this method, the number of people assigned to each group is usually almost equal. Blocks are formed based on the considered variables and within each block, half of the people are involved and half are considered as witnesses. The main goal in this method is to balance the number of participants in each group.
| 3 | Iran (Islamic Republic of) | Rouhollah Ahmadiyan | | Pharmacy faculty, Baqiyatallah University of medical science, South Sheikh-Bahaei St., Molladsadra St., Vanak Sq., Tehran, Iran | Roohollah.ahmadian75@yahoo.com | +98 21 6695 4709 | Bagheiat-allah University of Medical Sciences | Inclusion criteria: <br> Age: equal or more than 18 years;<br> The patient have written consciously and freely consent to participate in the study.<br> The patient's clinical symptoms (dry cough, shortness of breath, fever) confirm COVID-19.<br> Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation.<br> Less than 7 days have passed since the onset of symptoms.<br> | Exclusion criteria: <br> History of allergy to the ingredients;<br> Hypersensitivity reaction while taking this herbal nasal spray;<br> The patient is in another clinical trial at the same time;<br> The patient needs to receive medical care from the intensive care unit;<br> Pregnancy;<br> Lactation.<br> | COVID-19. <br>Covid-19;U07.1 | Intervention 1: Intervention group: "Curcumin and Resveratrol" Capsule (Each capsule contains 200 mg of curcumin, 200 mg of resveratrol as active ingredients, and 100 mg of lactose as filler), 1 Cap. every 12 hours, for 7 days (In addition to routine treatment according to the latest national guideline for the treatment of new corona-virus). Intervention 2: Control group: routine treatment according to the latest national guideline for the treatment of new corona-virus. | Clinical symptoms (fever). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Thermometer.;Clinical symptoms (respiratory distress). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Pulse-oxymetery device.;Clinical symptoms (dry cough). Timepoint: Daily monitoring, but the result of baseline (before the initiation of intervention), and day 7 from the initiation, is recorded. Method of measurement: Physical examination,questionnaire. | | | | No | False | | |
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| IRCT20161206031256N3 | 15 June 2020 | Using interferon to treat COVID-19 | Evaluation and comparison of the effect of two interferon alpha and beta antiviral drugs on the prognosis of patients with COVID 19 | | Mashhad University of Medical Sciences | 2020-06-02 | 20200602 | IRCT | http://en.irct.ir/trial/48329 | Recruiting | No | 18 years | no limit | Both | 2020-05-23 | 76 | interventional | Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Crossover, Purpose: Treatment, Randomization description: Simple Randomization using the envelope placement method, Blinding description: Eligible patient will be randomized in 4 groups, two groups will receive interferon (alpha or beta) and two group will receive placebo. the subjects, investigator, and the data analysts will remain blinded. | 2-3 | Iran (Islamic Republic of);Iran (Islamic Republic of) | maryam Khoshkhui | | Ghaem hospital, Ahmad abad St, Mashhad, Khorasan Razavi | b.ghaem@mums.ac.ir | +98 51 3840 0001 | Mashhad University of Medical Sciences | Inclusion criteria: <br> Adult over 18 years<br> Clinical diagnosis of COVID-19<br> | Exclusion criteria: History of allergy to human albumin or interferon | COVID-19. <br>the code for the confirmed diagnosis of COVID-19;RA01.0. | Intervention 1: Intervention group 1: patients who will receive standard care plus 4 consecutive doses of intramuscular injection of beta-interferon (each vial contains 30 micrograms of interferon equivalent to 6 million international units. Intervention 2: Intervention group 2: : patients who will receive standard care plus 2 doses of subcutaneous injection of Alpha-interferon (each vial contains 180 micrograms of interferon) with 7 day interval. Intervention 3: Control group 1: patients who will receive standard care plus beta-interferon placebo. Intervention 4: Control group 2: patients who will receive standard care plus alpha-interferon placebo. | Body temperature. Timepoint: Before intervention, on day of 1 until discharge with 3 day interval. Method of measurement: Thermometer, Celsius.;Respiratory rate. Timepoint: Before intervention, on day of 1 until discharge with 3 day interval. Method of measurement: Pulse oximeter, Breaths per minute.;The ratio of arterial oxygen partial pressure to fractional inspired oxygen. Timepoint: Before intervention, on day of 1 until discharge with 3 day interval. Method of measurement: Ventilator, Millimeter of mercury (mmHg).;Blood gas level. Timepoint: Before intervention, on day of 1 until discharge with 3 day interval. Method of measurement: Blood Gas Analyzer, percent. | | | | No | False | | |
| → | IRCT20160126026217N4 | 15 June 2020 | Investigation of the effects of prone position on cardiac and respiratory status in patients with Coronavirus | Investigation of the effects of prone position on respiratory status, hemodynamics, hospital stay and transfer to intensive care unit in patients with Covid-19: A randomized controlled clinical trial | | Khoram-Abad University of Medical Sciences | 2020-06-08 | 20200608 | IRCT | http://en.irct.ir/trial/48403 | Not Recruiting | No | 18 years | 65 years | Both | 2020-06-21 | 74 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The patients by block randomization assigned in intervention and control groups. Classification is done using a random number table. Classes by age(below 50 years/ older 50 years) and gender (male/female). It should be noted that the volume of each block is 4 cases, thus creating 6 different combinations of 4 blocks and randomly selecting the blocks. Blocking and allocation sequences for concealment will be done by the non-involved researcher. | N/A | Iran (Islamic Republic of) | Sajad Yarahmadi | | Lorestan university medical sciences, km 5 Road of Khorram Abad - Boroujerd - opposite to the Kahriz village | s.yarahmadi000@gmail.com | +98 66 3324 3143 | Khoram-Abad University of Medical Sciences | Inclusion criteria: <br> All patients with COVID-19 based on standard diagnosed test and had at least one respiratory symptom<br> Age between 18 and 65 years<br> Willing to participate in the study<br> | Exclusion criteria: <br> Do not use mechanical ventilation devices<br> Absence of respiratory diseases such as asthma and COPD<br> Not suffering from hypertension<br> No history of heart failure<br> No history of orthopedic and spinal problems<br> No history of neurological diseases<br> Lack of anemia<br> Lack of treatment-induced pulmonary complications such as barometer and chest tube installation<br> No history of thoracic surgery in the last 6 months<br> | Covid-19. <br>Covid-19;RA01.0 | Intervention 1: Intervention group: In this group, participants will be in the prone position for 90 minutes for the first time. After evaluating the initial outcomes, the participant will be asked to be in the prone position for 6 to 8 hours until the clearance time, and then the secondary outcomes will be evaluated. Intervention 2: Control group: In this group, participants will be in their usual position for 90 minutes for the first time, after evaluating the initial outcomes, the participant will be asked to be in his usual positions until the time of discharge, and then the secondary outcomes will be evaluated. | Mean blood pressure. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Digital sphygmomanometer.;Heart rate. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Pulse oximeter device.;Oxygen saturation. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Pulse oximeter device.;Respiratory rate. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Count the number of breaths per minute.;Breath shortness. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Visual analog scale for breath shortness.→Breath shortness. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Visual analog scale for breath shortness.;Respiratory rate. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Count the number of breaths per minute.;Oxygen saturation. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Pulse oximeter device.;Heart rate. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Pulse oximeter device.;Mean blood pressure. Timepoint: At 0, 30, 60, 90 and 120 minutes after the first intervention. Method of measurement: Digital sphygmomanometer. | | | | Yes | False | | |
| IRCT20200422047168N2 | 15 June 2020 | Clinical trial study of the therapeutic effect of Ivermectin, besides Kaletra and Chloroquinein in patients with Coronavirus disease 2019 (COVID-19) | A randomized clinical trial study, comparison of the therapeutic effects of Ivermectin, Kaletra and Chloroquine with Kaletra and Chloroquine in the treatment of patients with coronavirus 2019 (COVID-19) | | Ahvaz University of Medical Sciences | 2020-05-30 | 20200530 | IRCT | http://en.irct.ir/trial/48444 | Recruiting | No | 18 years | no limit | Both | 2020-05-30 | 60 | interventional |
Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we will use the Restricted randomization method of block randomization. Blockage is usually used to balance the number of samples allocated to each of the studied groups. This feature helps researchers to equalize the number of samples allocated to each of the studied groups in cases where intermediate analyzes are required during the sampling process. All blocks are the same size, and in this two-group experiment we will have 6 blocks (including 3 participants in the intervention group and 3 participants in the control group).
Random allocation software is also used to randomize random sequence production software (Random allocation software).
To conceal, we use Allocation concealment, which refers to the method used to perform a random sequence on study participants, so that the as | 2-3 | Iran (Islamic Republic of) | Ahvaz University of Medical Sciences | | Alimentary Tract Research Center Imam Khomeini Hospital Ahvaz Jundishapur University of Medical Sciences Ahvaz, Iran | zahrashokati@gmail.com | +98 61 3333 5678 | Ahvaz University of Medical Sciences | Inclusion criteria: <br> People over 18 years old<br> Real-time PCR test results for SARS-CoV-2 virus were positive after sampling (nasopharynx and oropharynx swab samples)<br> The manifestations of virus pneumonia in CT scans of their lungs were quite obvious.<br> Their O2 Saturation percentage were 93% or lower<br> | Exclusion criteria: <br> History of renal failure<br> Taking drugs that interfere with Ivermectin<br> Patients who have been admitted to other clinical trials<br> | covid-19. <br>Covid-19, confirmed cases, positive test result;U07.1 | Intervention 1: Intervention group: On the first day, patients will receive chloroquine at a dose of 200 mg, and from the second day for six consecutive days, they will receive Lopinavir / ritonavir (Kaletra) at a dose of 400/100 mg. At the first day,in addition to the above drugs,Ivermectin, 200–150 µg/kg? is given. Intervention 2: Control group: On the first day, patients will receive chloroquine at a dose of 200 mg, and from the second day for six consecutive days, they will receive Lopinavir / ritonavir (Kaletra) at a dose of 400/100 mg. | Reduce the mortality rate of patients with Covid-19. Timepoint: days 0-7. Method of measurement: Based on the percentage of discharged Covid-19 patients. | | | | Yes | False | | |
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| EUCTR2020-001271-33-FR | 6 July 2020 | HYCOVID - Hydroxychloroquine versus placebo chez les patients ayant une infection COVID-19 à risque d’aggravation secondaire : étude prospective multicentrique randomisée en double aveugle | HYCOVID - Hydroxychloroquine versus placebo chez les patients ayant une infection COVID-19 à risque d’aggravation secondaire : étude prospective multicentrique randomisée en double aveugle - HYCOVID | | CHU Angers | 24/03/2020 | 20200324 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001271-33 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 31/03/2020 | 1300 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| France | chef de projets | | 4 rue Larrey | DRCI-Promotion-Interne@chu-angers.fr | 0241353342 | CHU Angers | Inclusion criteria: <br>- Patient majeur
<br>- Infection COVID-19 confirmée par RT-PCR SARS-Cov2 ou, à défaut, par scanner thoracique en faveur d’une pneumopathie virale à prédominance périphérique dans un contexte évocateur
<br>- Diagnostic porté depuis moins de 48h
<br>- Présence d’au moins un des deux facteurs de risque d’évolution compliquée suivant :
<br> - âge = 75 ans
<br> - oxygénodépendance avec saturation capillaire périphérique en oxygène (SpO2) = 94% en air ambiant ou un ratio pression partielle en oxygène (PaO2) sur fraction en oxygène dans l’air inspiré (FiO2) = 300 mmHg.
<br>- Patient affilié ou bénéficiaire d’un régime de sécurité sociale
<br>- Consentement écrit signé du patient ou d’un proche ou, en cas d’impossibilité, procédure d’inclusion en urgence
<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 750<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 750<br> | Exclusion criteria: <br>- RT-PCR SARS-Cov2 négative
<br>- Saturation capillaire périphérique en oxygéne inférieure ou égale à 94% (SpO2 =94%) malgré une oxygénothérapie supérieure ou égale à 3L/min (= 3L/min)
<br>- Défaillance d’organe nécessitant une admission en réanimation ou unité de soins-continus
<br>- Comorbidité engageant le pronostic vital à court terme (espérance de vie < 3 mois)
<br>- Toute raison rendant le suivi à J28 impossible
<br>- Traitement en cours par hydroxychloroquine
<br>- Contre-indication absolue au traitement par hydroxychloroquine (hypersensibilité connue, traitement concomitant à risque de torsades de pointe)
<br>- ECG chez les patients à risque mettant en évidence un allongement du QT corrigé supérieure à 440 ms chez l’homme et 460 ms chez la femme.
<br>- Femme enceinte, allaitante ou parturiente
<br>- Personne privée de liberté par décision judiciaire ou administrative
<br>- Personne faisant l’objet de soins psychiatriques sous la contrainte
<br>- Personne faisant l’objet d’une mesure de protection légale
<br><br> | Patient atteint du Covid-19;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Plaquenil®<br>Pharmaceutical Form: Tablet<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: Le critère de jugement principal est le décès quelle qu’en soit la cause ou le recours à une intubation et ventilation invasive dans les 14 jours (J14) suivant l’inclusion et le début du traitement (J0).;Primary end point(s): Le critère de jugement principal est le décès quelle qu’en soit la cause ou le recours à une intubation et ventilation invasive dans les 14 jours (J14) suivant l’inclusion et le début du traitement (J0).;Secondary Objective: Les objectifs secondaires sont :<br><br>1) Évaluer l’efficacité de l’hydroxychloroquine versus placebo chez les patients COVID-19 sur : <br>a- l’évolution clinique via l’échelle OSCI (Ordinal Scale for Clinical Improvement) pour COVID-19 de l’OMS<br>b- la mortalité toute cause <br>c- le portage viral <br>d- l’incidence des accidents thrombo-emboliques veineux <br><br>2) Évaluer l’efficacité de l’hydroxychloroquine versus placebo dans le sous-groupe des personnes âgées de 75 ans ou plus sur :<br>a- l’évolution clinique via l’échelle OSCI pour COVID-19 de l’OMS <br>b- la mortalité toute cause<br><br>3) Évaluer la tolérance de l’hydroxychloroquine versus placebo sur la survenue d’évènements indésirables graves<br><br>Objectifs ancillaires <br>Évaluer, dans un sous-groupe de patients COVID-19, l’impact de l’hydroxychloroquine versus placebo sur l’évolution des cytokines et des marqueurs biologiques de l’immunité, de l’inflammation et de l’hémostase<br>;Main Objective: L’objectif principal est d’évaluer l’efficacité de l’hydroxychloroquine versus placebo sur le taux de décès ou de recours à une ventilation invasive chez les patients ayant une infection COVID-19 à haut risque d’aggravation. | | | | Yes | False | | |
| → | EUCTR2020-001258-23-IT | 6 July 2020 | COLCHICINE TO COUNTERACT INFLAMMATORY RESPONSE IN COVID-19 PNEUMONIA | COLCHICINE TO COUNTERACT INFLAMMATORY RESPONSE IN COVID-19 PNEUMONIA - ColCOVID19 | | AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA | 20/04/2020 | 20200420 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001258-23 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 20/04/2020 | 310 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: SOC Standard of Care<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Italy | CORRADO CONFALONIERI Segreteria CE | | VIA GRAMSCI | cconfalonieri@ao.pr.it | 00390521703013 | AZIENDA OSPEDALIERO-UNIVERSITARIA DI PARMA | Inclusion criteria: <br>- Patients aged 18 years or above <br>- Belonging to the low- to intermediate-risk strata according to the criteria of the Emilia-Romagna Region, Italy (PG/2020/0240975 del 21 marzo 2020 “Protocollo terapeutico per la terapia antivirale per I pazienti con infezione da Covid19”, Scenario 2 and 3A, in a scale of increased levels of severity) and to the SIMIT guidelines (http://www.simit.org/IT/formazione/linee-guida.xhtml)), that is patients in stable medical conditions (MEWS<3, see Table below) with the following characteristics:<br><br>-Pauci-symptomatic with positive nasopharyngeal swab for COVID-19 + age =70 years and/or clinical risk factors for poor outcome (clinically relevant chronic lung disease, diabetes and/or heart disease) + even minimal CT scan findings (>5% of lung parenchima) suggestive of viral pneumonia (ground-glass opacities and/or patchy consolidation, and/or interstitial changes with a peripheral distribution)<br><br>- Symptomatic (temperature =38°C and/or intensive cough and/or shortness of breath), + CT imaging showing typical findings of viral pneumonia (ground-glass opacities, multifocal patchy consolidation, and/or interstitial changes with a peripheral distribution) and positive or pending pharyngo-nasal swab for COVID-19. <br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 20<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 10<br> | Exclusion criteria: <br>- Unstable clinical conditions (MEWS=3)<br>- Respiratory rate > 30 rpm, PaO2/FiO2 < 200mmHg<br>- Pregnant or breast feeding<br>- Hepatic failure Child-Pugh C<br>- Enrollment in other pharmacological studies <br>Treatment with <br>- Chronic treatment with colchicine<br>- Ongoing treatment with antiviral drugs that include ritonavir or cobicistat (Previous treatment with antiviral drugs that include ritonavir or cobicistat is NOT an exclusion criteria)<br>- Any medical condition or disease which in the opinion of the Investigator may place the patient at unacceptable risk for study participation.<br> | patients with COVID-19 infection with pneumonia and stable conditions.;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: COLCHICINA<br>Product Name: COLCHICINA<br>Pharmaceutical Form: Tablet<br><br> | Timepoint(s) of evaluation of this end point: 28 days;Primary end point(s): Time to clinical improvement: defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scale (cfr 7.5.2) or live discharge from the hospital (whatever comes first) as recommended by Coronavirus Disease (COVID – 2019) R&D Geneva World Health Organization http://www.who.int/;Secondary Objective: - Clinical efficacy of colchicine compared to the control arm by clinical severity<br>- Duration of predefined symptoms and signs (if applicable)<br>- Duration of supplemental oxygen dependency (if applicable)<br>- Incidence of new mechanical ventilation use during the study<br>- Duration of new mechanical ventilation use during the Study<br>- Need for admission into intensive care unit (ICU)<br>- Evaluate duration of hospitalization (days)<br>- Evaluate the 28-day mortality rate<br>;Main Objective: To evaluate the clinical efficacy of colchicine relative to the control arm in adult patients hospitalized for COVID-19 with pneumonia and clinically stable conditions→Secondary Objective: - Clinical efficacy of colchicine compared to the control arm by clinical severity<br>- Duration of predefined symptoms and signs (if applicable)<br>- Duration of supplemental oxygen dependency (if applicable)<br>- Incidence of new mechanical ventilation use during the study<br>- Duration of new mechanical ventilation use during the Study<br>- Need for admission into intensive care unit (ICU)<br>- Evaluate duration of hospitalization (days)<br>- Evaluate the 28-day mortality rate<br>;Primary end point(s): Time to clinical improvement: defined as time from randomization to an improvement of two points from the status at randomization on a seven-category ordinary scale (cfr 7.5.2) or live discharge from the hospital (whatever comes first) as recommended by Coronavirus Disease (COVID – 2019) R&D Geneva World Health Organization http://www.who.int/;Timepoint(s) of evaluation of this end point: 28 days;Main Objective: To evaluate the clinical efficacy of colchicine relative to the control arm in adult patients hospitalized for COVID-19 with pneumonia and clinically stable conditions | | | | Yes | False | | |
| EUCTR2020-002230-32-GB | 6 July 2020 | Investigating potential new therapies for COVID-19. | Rapid Experimental Medicine for COVID-19 - DEFINE | | University of Edinburgh | 11/06/2020 | 20200611 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002230-32 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 23/06/2020 | 100 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United Kingdom | Annya Bruce | | Queen's Medical Research Institute | Annya.Bruce@ed.ac.uk | 01312429180 | University of Edinburgh | Inclusion criteria: <br>Inclusion criteria: <br>? Provision of informed consent from the patient or representative <br>? Aged at least 16 years <br>? If the patient is of child bearing potential*, the patient, and their partner(s), agree to use medically-accepted double-barrier methods of contraception (eg, barrier methods, including male condom, female condom or diaphragm with spermicidal gel) during the study and for at least 90 days after termination of study therapy. A vasectomised partner would be considered an appropriate birth control method provided that the partner is the sole male sexual partner and the absence of sperm has been confirmed.<br>? COVID-19 positive <br><br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 0<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range 0<br> | Exclusion criteria: <br>Exclusion criteria: <br><br>• Current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled cardiac disease (NYHA class IV), uncontrolled renal disease (eGFR <30 mL/min/1.73 m2), severe liver dysfunction (ALT/AST >5x ULN) or bone marrow failure (Hb <80 g/LAND ANC<0.5 mm3 AND platelet count <50,000 uL)<br>? Women who are pregnant or breastfeeding. <br>• Participation in another clinical trial of an investigational medicinal product (CTIMP)<br>• Known hypersensitivity to the IMP or excipients (e.g. lactose)<br>• Pre-existing or concomittant use of off-label treatments for COVID-19<br>• Significant electrolyte disturbance (hyperkalaemia K+ >5.0 mmol/L or hyponatraemia Na+ < 120mmol/L)<br>• Patient currently receiving potassium sparing diuretics that cannot be reasonably withheld <br>• Patient currently receving prophylactic or therapeutic anticoagulants or antiplatelet agents that cannot be reasonably withheld <br><br>• Ongoing dialysis<br>• History of serious liver disease (Child Pugh score > 10)<br>• Hemoglobin < 80 g/L <br>• Any known allergy to the IMP/excipients<br>• Severe uncontrolled diabetes mellitus<br>• In the Investigator’s opinion, patient is unwilling or unable to comply with drug administration plan, laboratory tests or other study procedures. <br><br><br><br><br> | COVID-19;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: TD139<br>Pharmaceutical Form: Inhalation powder, hard capsule<br>INN or Proposed INN: TD139<br>Current Sponsor code: TD139<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 10mg-<br><br>Trade Name: Futhan®50 <br>Product Name: Futhan®50 <br>Pharmaceutical Form: Injection<br>INN or Proposed INN: Nafamostat mesilate <br>Current Sponsor code: FUTHAN?50 INJ.<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 50-<br><br> | Timepoint(s) of evaluation of this end point: Daily assessments;Primary end point(s): Safety will be assessed using:<br><br>• Haematological and biochemical safety laboratory investigations.<br>• Physical examination<br>• Vital signs (blood pressure/heart rate/temperature and respiratory rate)<br>• Daily electrocardiogram (ECG) readings <br>• Adverse events<br><br>;Secondary Objective: 1) To determine what the drugs does to the body (pharmacodynamics) and what the body does to the drug (pharmacokinetics) of the proposed trial treatments in COVID-19 patients. <br>2) Assess the response of key exploratory biomarkers/pathways during treatment period. <br>3)To evaluate the improvement or deteroriation of patients in each treatment arm. <br>4) To evaluate the number of oxygen-free days. <br>5) To evaluate ventilator-free days and incidence and duration of any form of new ventilation use. <br>6) To evaluate the amount of virus in the patient using saliva/oropharyngeal/nose samples <br>To evaluate time to discharge<br>7) Duration of total hospital stay<br>8) To evaluate the use of renal dialysis or haemofiltration for each treatment arm.<br><br><br>;Main Objective: To evaluate the safety of candidate agents as add-on therapy to standard of care in patients with COVID-19. Safety will be assessed using:<br><br>• Haematological and biochemical safety laboratory investigations (blood tests).<br>• Physical examination<br>• Vital signs (blood pressure/heart rate/temperature and respiratory rate)<br>• Daily electrocardiogram (ECG) readings <br>• Adverse events<br> | | | | Yes | False | | |
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| EUCTR2020-001765-37-ES | 27 July 2020 | Pragmatic clinical trial of hydroxychloroquine in the treatment of oncohematological patients and health professionals with COVID-19 infection without radiological alteration. | Pragmatic clinical trial to evaluate the efficacy of hydroxychloroquine in the treatment of COVID-19 infection in two cohorts: patients with oncohaematological disease and SARS-CoV-2 positive without radiological alteration and sars-cov-2 positive professionals without radiological alteration | | Institut Català d’Oncologia | 13/04/2020 | 20200413 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001765-37 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 11/04/2020 | 103 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | Margarita García Martín | | Av Gran Via de l'Hospitalet 199-203 | mgarciamartin@iconcologia.net | 0034932607331 | Institut Català d’Oncologia | Inclusion criteria: <br>Patient Cohort <br>1) Patients diagnosed with onco-haematological disease<br>2) Age: over 18 years old.<br>3) ECOG performance status < 2 (Karnofsky>60%)<br>4) Life expectancy > 3 months for the neoplastic disease.<br>5) Patients with laboratory confirmed Covid-19 diagnosis (PCR)<br>6) Patients with clinical signs compatible with Covid-19: fever, cough, dyspnea.<br>7) Patients should have chest radiological imaging (plaque or CT scan) with no affectation compatible with Covid-19.<br>8) NIT-1-2 patients <br>9) Mild functional alteration of organs, defined as:<br>- Calculated creatinine clearance > 30 ml/min<br>- Bilirubin < 25 µmol/l (1.5 mg/dl) <br>- AST/ALT < 2.5 times upper limit of the centre's normality<br>- Alkaline phosphatase < 2.5 times upper limit of centre's normality<br>- Normal spinal function: Hematology: neutrophils > 1.0 x 109/l, lymphocytes > 0.5 x 109/l, platelets > 75 x 109/l, hemoglobin > 8 g/100ml.<br>-PT and PTT: normal<br>10) To give informed consent in accordance with current legal regulations.<br><br>Professional Cohort <br>1) Age: over 18 years old.<br>2) Diagnosis Covid-19 confirmed by laboratory (PCR)<br>3) They must have a chest X-ray image (plate or CT) with no Covid-19 compatible affectation.<br>4) Adequate organic function, defined as:<br>- Calculated creatinine clearance > 30 ml/min.<br>- Bilirubin < 25 µmol/l (1.5 mg/dl) <br>- AST/ALT < 2.5 times upper limit of the centre's normality<br>- Alkaline phosphatase < 2.5 times upper limit of centre's normality<br>-Normal spinal function: Hematology: neutrophils > 1.0 x 109/l, lymphocytes > 0.5 x 109/l, platelets > 75 x 109/l, hemoglobin > 8 g/100ml.<br>- PT and PTT: normal<br>5) To give informed consent in accordance with current legal regulations.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 60<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 43<br> | Exclusion criteria: <br>Patient cohort and professional cohort<br>? Uncontrolled intercurrent disease including infections other than CoVID19, symptomatic heart failure, unstable angina pectoris, cardiac arrhythmia, psychiatric or social disorder that may limit study requirements <br>? To be receiving any other drug or product under study<br>? Allergy to one or more of the medications in the trial<br>? Chronic concomitant immunosuppressive medication<br> | SAR COV2 virus infection, without radiological affectation. <br>MedDRA version: 20.0
Level: LLT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 100000004862
<br>MedDRA version: 20.0
Level: PT
Classification code 10070255
Term: Coronavirus test positive
System Organ Class: 10022891 - Investigations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: hydroxychloroquine<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Hydroxychloroquine<br>CAS Number: 118-42-3<br>Concentration unit: mg milligram(s)<br>Concentration type: range<br>Concentration number: 400-800<br><br> | Timepoint(s) of evaluation of this end point: 14 days after treatment initiation;Primary end point(s): Percentage of patients (cohort A) and professionals (cohort B) who achieve control of the disease without symptoms in 14 days, assessed by chest radiography without pneumonia.;Secondary Objective: Evaluate the toxicity profile of the treatment.;Main Objective: To determine the efficacy of hydroxychloroquine in the treatment of SARS-COV2 infection in oncohaematological patients without radiological alteration and SARS-COV2 positive professionals without radiological alteration. | | | | No | False | | |
| → | EUCTR2020-001707-16-ES | 27 July 2020 | PHASE III RANDOMIZED, UNICENTRIC OPEN, CONTROLLED CLINICAL TRIAL TO DEMONSTRATE THE EFFECTIVENESS OF TOCILIZUMAB AGAINST SYSTEMIC CORTICOTHERAPY IN PATIENTS ENTERED BY COVID-19 WITH BILATERAL PNEUMONIA AND BAD EVOLUTION | PHASE III RANDOMIZED, UNICENTRIC, OPEN, CONTROLLED CLINICAL TRIAL TO DEMONSTRATE THE EFFECTIVENESS OF TOCILIZUMAB AGAINST SYSTEMIC CORTICOTHERAPY IN PATIENTS ENTERED BY COVID-19 WITH BILATERAL PNEUMONIA AND BAD EVOLUTION - TOCICOVID | | IIS BIODONOSTIA | 22/07/2020 | 20200722 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001707-16 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 25/06/2020 | 60 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Spain | IIS BIODONOSTIA | | PASEO DOCTOR BEGIRISTAIN S/N | | 943006288 | IIS BIODONOSTIA | Inclusion criteria: <br>Patient over 18 years old<br>2) Ability to grant consent<br>3) Bilateral pneumonia caused by SARS-CoV-2 without response to the treatment used according to local protocol. This is defined as persistence of fever (above 37.5ºC without other focus) and respiratory worsening (more dyspnea, more cough, oxygen therapy at increasing doses, worsening of the degree of respiratory distress according to the PaO2 / FiO2 ratio in categories “mild, moderate or serious ") or absence of improvement with respect to the previous state<br>4) Persistently elevated inflammatory markers, among which must be met: ferritin greater than 1000 ng / mL and / or D-dimer greater than 1500 ng / mL and / or IL-6 greater than 40 pg / mL [35-37].<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 60<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 60<br> | Exclusion criteria: <br>1) Pregnancy and lactation<br>2) Terminal situation or life expectancy less than 30 days in the judgment of the researcher<br>3) Allergy or intolerance to any of the drugs under study or to any of the excipients of the preparations (eg polysorbate 80)<br>4) Non-tolerable interaction of the study drugs with some essential chronic medication of the patient<br>5) Transaminases raised above five times the upper limit of normal<br>6) Severe neutropenia (<500 cells / mm3)<br>7) Plateletpenia <50,000 / mm3<br>8) Sepsis (clinical suspicion of active infection at another level with a value on the qSOFA scale of two or more points) or septic shock (need for vasopressors to maintain a mean arterial pressure greater than or equal to 65<br>10<br>mmHg, with a lactate greater than 2 mmol / L, despite adequate volume replacement<br>9) Another active infection at any level<br>10) Complicated diverticulitis or intestinal perforation<br>11) Kidney failure with estimated glomerular filtration less than 30 mL / min<br>12) Liver failure (Child B onwards)<br>13) Previous use (during the acute process or as chronic medication for another reason) of medication with potential effect in this phase of the disease (Janus kinase inhibitors, interleukin-1 inhibitors, other immunosuppressants or immunomodulators that, in the investigator's judgment) could have an effect on the disease based on pathophysiological criteria or previous research or started up in this same period)<br>14) Be included in another clinical trial<br>15) Patients who, due to their current situation, their baseline situation or other aspects, in the opinion of the researcher, are not considered candidates to enter the study<br> | bilateral SARS-CoV-2 pneumonia with poor clinical course;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Roactemra<br>Product Name: tocilizumab<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: Tocilizumab<br>CAS Number: 375823-41-9<br>Other descriptive name: TOCILIZUMAB<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 20-<br><br>Trade Name: Urbason<br>Product Name: Metilprednisolona<br>Pharmaceutical Form: Solution for injection/infusion<br>INN or Proposed INN: metilprednisolona hemisuccinato sódico<br>Other descriptive name: METHYLPREDNISOLONE SODIUM SUCCINATE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 331-<br><br> | Main Objective: To demonstrate the superiority of tocilizumab over corticosteroids with respect to the improvement of the respiratory situation and hyperactivation of the immune system;Timepoint(s) of evaluation of this end point: Quantitative variable that will be analyzed as qualitative (better, worse) based on whether there is a change in the previously described graduation.<br>- Each one is a quantitative variable. They will be measured as such and also qualitatively (worse, better) independently and together. A worsening of 2 of the 3 variables will be considered “worse”; “Better” if there is improvement in 2 of the 3.<br>- qualitative variable (yes or no)<br>- respiratory worsening or need for mechanical ventilation or in-hospital death;Primary end point(s): Respiratory situation at 24 hours, 3 and 7 days based on PaO2 / FiO2 ratio that graduates respiratory distress from mild (200-300), moderate (100-200) and severe (<100). In addition, it will include: presence of dyspnea and grade according to the New York Health Association (NYHA) scale, presence of respiratory work and respiratory rate (FR).<br>ii. PCR value, LDH, D-dimer, ferritin, IL-6 and total lymphocytes at 24 hours, 3 and 7 days. Each one is a quantitative variable. They will be measured as such and also qualitatively (worse, better) independently and together. A worsening of 3 of the 5 variables will be considered “worse”; “Better” if there is improvement in 3 out of 5.<br>iii. Mechanical ventilation: qualitative variable (yes or no)<br>iv. Combined variable of variables i and / or iii and / or in-hospital mortality;Secondary Objective: i. Evaluate the time until admission to the ICU<br>ii. Assess the time until intubation<br>iii. Assess the length of ICU admission<br>iv. Assess the total length of admission<br>v. Assess in-hospital mortality<br>saw. Assess mortality in the medium term (30 and 60 days)<br>vii. Assess the respiratory situation in the medium term (30 and 60 days)<br>viii. Assess intracurrent intercurrent infections→Primary end point(s): Respiratory situation at 24 hours, 3 and 7 days based on PaO2 / FiO2 ratio that graduates respiratory distress from mild (200-300), moderate (100-200) and severe (<100). In addition, it will include: presence of dyspnea and grade according to the New York Health Association (NYHA) scale, presence of respiratory work and respiratory rate (FR).<br>ii. PCR value, LDH, D-dimer, ferritin, IL-6 and total lymphocytes at 24 hours, 3 and 7 days. Each one is a quantitative variable. They will be measured as such and also qualitatively (worse, better) independently and together. A worsening of 3 of the 5 variables will be considered “worse”; “Better” if there is improvement in 3 out of 5.<br>iii. Mechanical ventilation: qualitative variable (yes or no)<br>iv. Combined variable of variables i and / or iii and / or in-hospital mortality;Timepoint(s) of evaluation of this end point: Quantitative variable that will be analyzed as qualitative (better, worse) based on whether there is a change in the previously described graduation.<br>- Each one is a quantitative variable. They will be measured as such and also qualitatively (worse, better) independently and together. A worsening of 2 of the 3 variables will be considered “worse”; “Better” if there is improvement in 2 of the 3.<br>- qualitative variable (yes or no)<br>- respiratory worsening or need for mechanical ventilation or in-hospital death;Secondary Objective: i. Evaluate the time until admission to the ICU<br>ii. Assess the time until intubation<br>iii. Assess the length of ICU admission<br>iv. Assess the total length of admission<br>v. Assess in-hospital mortality<br>saw. Assess mortality in the medium term (30 and 60 days)<br>vii. Assess the respiratory situation in the medium term (30 and 60 days)<br>viii. Assess intracurrent intercurrent infections;Main Objective: To demonstrate the superiority of tocilizumab over corticosteroids with respect to the improvement of the respiratory situation and hyperactivation of the immune system | | | | No | False | | |
| EUCTR2020-001890-56-ES | 27 July 2020 | Clinical trial to evaluate the efficacy and safety of gammaglobulins in COVID-19 treatment | Double-blind randomized placebo-controlled clinical trial to evaluate the efficacy and safety of the use of intravenous gammaglobulins in the treatment of patients with COVID-19 | | Universidad Católica de Murcia (UCAM) | 22/07/2020 | 20200722 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001890-56 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 10/06/2020 | 100 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Spain | Bioithas | | Parque Cientifico de Alicante. Edificio Naves Incubadoras | laura.navarro@bioithas.com | | Bioithas, S.L. | Inclusion criteria: <br>- Adults 18 years of age or over.<br><br>- SARS-CoV-2 infection confirmed by PCR technique from samples of the nasopharynx and / or sputum and / or the upper respiratory tract.<br><br>- Interval between the onset of symptoms and randomization greater than or equal to 5 days. The onset of symptoms is mainly based on fever. If there is no fever, cough or other related symptoms may be used.<br><br>- Patients with a diagnosis of multilobar pneumonia attributed to SARS-Cov-2 infection and diagnosed by chest X-ray or CT.<br><br>- At least one of the following conditions: respiratory distress, Respiratory Rate (RF) = 30 times / min; oxygen saturation = 90% at rest; PaO2 / FiO2 ratio = 300 mmHg; respiratory failure with a clinical situation that in clinical judgment requires mechanical ventilation; shock situation; requiring monitoring and ICU treatment due to the patient's clinical situation.<br><br>- At least one of the following conditions: levels above the normal range ??in a peripheral blood sample of: Ferritin, D-Dimer, Procalcitonin and IL-6.<br><br>- Signing the informed consent on a voluntary basis.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 30<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 70<br> | Exclusion criteria: <br>- There are other culture microbiological evidences, antigen study or serology that can explain pneumonia, which include, but are not limited to: influenza A virus, influenza B virus, bacterial pneumonia, fungal pneumonia or suspect a non-infectious process.<br><br>- Allergy to intravenous immunoglobulin or its preparation components.<br><br>- Patients with selective IgA, IgM or IgG deficiency or another condition that makes the patients unsuitable for study therapy.<br><br>- Pregnant or lactating women.<br><br>- That the investigators consider it inappropriate to clinical criteria and other circumstances in which the investigator determines that the patient is not suitable for the clinical trial.<br> | Patients with severe symptoms of COVID-19, a disease caused by infection with the SARS-CoV-2 virus.;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Flebogamma (Human normal immunoglobulin (IVIg))<br><br>One ml contains: Human normal immunoglobulin,100mg ((purity of at least 97% IgG)<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: Gammaglobuline<br>CAS Number: 8000010-96-0<br>Other descriptive name: GAMMA GLOBULIN<br>Concentration unit: mg/l milligram(s)/litre<br>Concentration type: equal<br>Concentration number: 100-<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br> | Timepoint(s) of evaluation of this end point: End point 1: Between 0- and 28-days.;Primary end point(s): 1. Mortality, that is, number of deaths.;Secondary Objective: To evaluate the impact of the treatment on the clinical situation of the patients and on the inflammation markers at the end of the study period.;Main Objective: To evaluate the efficacy and safety of using intravenously administered gammaglobulin as treatment in patients with COVID-19. | | | | No | False | | |
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| EUCTR2020-001770-30-BE | 10 August 2020 | Experimental use of tocilizumab in COVID-19 related pneumonia. | COVID 19: Experimental use of tocilizumab (Roactemra®) in severe SARS-CoV-2 related pneumonia. | | CHU AMBROISE PARE | 15/04/2020 | 20200415 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001770-30 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 21/04/2020 | 60 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: standard of care which could include medicinal products <br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Belgium | dr Camelia Rossi | | Boulevard Kennedy 2 | camelia.rossi@hap.be | 3265413765 | CHU AMBROISE PARE | Inclusion criteria: <br>- Positive COVID status as defined by:
<br>PCR documented SARS-CoV-2 carriage in nasopharyngeal sample or evocative thoracic scan
<br>images of COVID-19 associated with typical clinical presentation
<br>- Hospitalized patients aged = 18 and = 75 years old
<br>- Signs of severe COVID-19 pneumonia (3 of the followings)
<br>- Patient wheezing or unable to speak in full sentences while at rest/with minimal
<br>effort
<br>- Respiratory rate >22
<br>- PaO2 <65 mmHg or SpO2 <90%
<br>- Repeated chest imaging is significantly worsening
<br>despite being on standard of care, which may include anti-viral treatment, low dose steroids
<br>and antibiotics.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 30<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 30<br> | Exclusion criteria: <br>- Immunosuppresion
<br>- End stage renal failure and dialysis
<br>- Life expectancy < 1 year (due to a condition other than COVID)
<br>- Active neoplasia (treated or not)
<br>- Breastfeeding and pregnant patients
<br>- Known severe allergic reactions to TCZ or other monoclonal antibodies
<br>- Non treated HIV infection, chronic B hepatitis, active C hepatitis, active tuberculosis
<br>infection
<br>- Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past
<br>6 months
<br>- Participating in other drug clinical trials<br> | viral pneumonia caused by the new coronavirus (SARS-CoV-2) <br>MedDRA version: 21.1
Level: PT
Classification code 10035737
Term: Pneumonia viral
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: ROACTEMRA<br>Product Name: tocilizumab<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: TOCILIZUMAB<br>CAS Number: 375823-41-9<br>Current Sponsor code: TOCILIZUMAB<br>Other descriptive name: TOCILIZUMAB<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 20-<br><br> | Timepoint(s) of evaluation of this end point: end of study;Primary end point(s): Clinical status assessed using a 7-category ordinal scale at Day 28;Secondary Objective: Not applicable;Main Objective: to evaluate the safety<br>and efficacy of the tocilizumab (Roactemra®) in hospitalized adults diagnosed with COVID-19. | | | | Yes | False | | |
| → | EUCTR2020-002574-27-FR | 10 August 2020 | A study to evaluate the safety and efficacy of XAV-19 in patients with COVID-19 induced moderate pneumonia | A randomized, double-blind, placebo-controlled phase 2a and 2b study to evaluate the safety and efficacy of XAV-19 in patients with COVID-19 induced moderate pneumonia - POLYCOR | | Nantes CHU | 15/06/2020 | 20200615 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002574-27 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 07/08/2020 | 368 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| France | Laëtitia Berly | | 5 Allée de l'ile Gloriette | bp-prom-regl@chu-nantes.fr | 0033253526204 | Nantes CHU | Inclusion criteria: <br>1.Willing and able to provide written informed consent prior to<br>performing study procedures<br>2.Male or female = 18 years<br>3.Hospitalized for COVID-19<br>4.Positive SARS-CoV-2 RT-PCR in any body specimen (nasopharynx,<br>saliva, sputum) = 10 days before enrolment<br>5.Evidence of pulmonary involvement (on lung examination<br>[rales/crackles] and/or chest-imaging [Chest X-ray or computed<br>tomography])<br>6.Requiring O2 supplement with SpO2 = 6L/min at screening<br>7.Requiring O2 supplementation with SpO2 = 94% on O2 therapy at<br>screening<br>8.First onset of COVID-19 symptoms = 10 days, among fever and/or<br>chills, headache, myalgias, cough, shortness of breath, whichever as<br>occurred fist<br>9.WOCBP must have a negative urinary pregnancy test the day of<br>inclusion<br>10.All sexually active male subjects must agree to use an adequate<br>method of contraception throughout the study period and for 90 days<br>after the last dose of study drug and agree to no sperm donation until<br>the end of the study, or for 90 days after the last dose of XAV-19,<br>whichever is longer<br>11.Patients with French social security<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 92<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 276<br> | Exclusion criteria: <br>1.Evidence of multiorgan failure (severe COVID-19)<br>2.Mechanically ventilated (including ECMO)<br>3.Receipt of immunoglobulins or any blood products in the past 30 days<br>4.Psychiatric or cognitive illness or recreational drug/alcohol use that in<br>the opinion of the investigator, would affect subject safety and/or<br>compliance<br>5.End-stage renal disease (eGFR < 15 ml/min/1,73 m2)<br>6.Child-Pugh C stage liver cirrhosis<br>7.Decompensated cardiac insufficiency<br>8.Known allergy, hypersensitivity, or intolerance to the study drug, or to<br>any of its components<br>9.Females of childbearing potential without contraceptive method, or<br>with positive pregnancy test, breastfeeding, or planning to become<br>pregnant during the study period<br>10.Current documented and uncontrolled bacterial infection.<br>11.Prior severe (grade 3) allergic reactions to plasma transfusion<br>12.Patient participating in another interventional clinical trial<br>13.Life expectancy estimated to be less than 6 months<br>14.Patient under guardianship or trusteeship<br> | Moderate COVID-19 <br>MedDRA version: 23.0
Level: PT
Classification code 10084460
Term: COVID-19 treatment
System Organ Class: 10042613 - Surgical and medical procedures
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: XAV-19<br>Product Code: XAV-19<br>Pharmaceutical Form: Solution for infusion<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br> | Main Objective: Phase 2a:<br>The primary objective of the study is to evaluate the Antibody titers of<br>XAV-19 treated patients versus placebo treated patients at Day 8.<br>Phase 2b:<br>The primary objective of the study is to compare duration until weaning<br>supplemental oxygen in the two groups of treatment.;Secondary Objective: Phase 2a:<br>a)Characterize pharmacokinetics (PK) of XAV-19 infected patients over<br>the time from D1 to D29<br>b)Evaluate the Antibody titers of XAV-19 and to compare Group 1<br>treated patients versus Group 2 treated patients at Day 8.<br>c)Assess safety and tolerability of XAV-19 vs. placebo and between<br>group 1 and group 2 treated patients over 29 days.<br>d)Describe groups of patients according to clinical variables<br>Phase 2b:<br>a)Evolution of National Early Warning Score (NEWS)<br>b)Changes in the 7-point ordinal scale between baseline and Day 15<br>c)Improvement of one category from admission using the 7-point ordinal<br>scale<br>d)Normalization of fever<br>e)Duration of oxygen therapy over 29 days<br>f)Oxygen requirement over 29 days<br>g)Transfer to ICU with need for IMV or high flow O2<br>h)Hospital length of stay<br>i)All cause of mortality<br>j)Safety of XAV-19;Primary end point(s): Phase 2a:<br>The primary endpoint is pharmacokinetic measurement of the antibody<br>titer of XAV-19 measurements of all treated patients and of all patients<br>in the placebo group at Day 8 (3 days after the last administration).<br>Phase 2b:<br>Time to weaning of supplemental oxygen.<br>If patient is still on oxygen at D15 or if the patient is weaned but put<br>back on oxygen then the delay will be censored at 15 days.;Timepoint(s) of evaluation of this end point: Phase 2a: Day 8<br>Phase 2b: Day 15→Timepoint(s) of evaluation of this end point: Phase 2a: Day 8<br>Phase 2b: Day 15;Primary end point(s): Phase 2a:<br>The primary endpoint is pharmacokinetic measurement of the antibody<br>titer of XAV-19 measurements of all treated patients and of all patients<br>in the placebo group at Day 8 (3 days after the last administration).<br>Phase 2b:<br>Time to weaning of supplemental oxygen.<br>If patient is still on oxygen at D15 or if the patient is weaned but put<br>back on oxygen then the delay will be censored at 15 days.;Secondary Objective: Phase 2a:<br>a)Characterize pharmacokinetics (PK) of XAV-19 infected patients over<br>the time from D1 to D29<br>b)Evaluate the Antibody titers of XAV-19 and to compare Group 1<br>treated patients versus Group 2 treated patients at Day 8.<br>c)Assess safety and tolerability of XAV-19 vs. placebo and between<br>group 1 and group 2 treated patients over 29 days.<br>d)Describe groups of patients according to clinical variables<br>Phase 2b:<br>a)Evolution of National Early Warning Score (NEWS)<br>b)Changes in the 7-point ordinal scale between baseline and Day 15<br>c)Improvement of one category from admission using the 7-point ordinal<br>scale<br>d)Normalization of fever<br>e)Duration of oxygen therapy over 29 days<br>f)Oxygen requirement over 29 days<br>g)Transfer to ICU with need for IMV or high flow O2<br>h)Hospital length of stay<br>i)All cause of mortality<br>j)Safety of XAV-19;Main Objective: Phase 2a:<br>The primary objective of the study is to evaluate the Antibody titers of<br>XAV-19 treated patients versus placebo treated patients at Day 8.<br>Phase 2b:<br>The primary objective of the study is to compare duration until weaning<br>supplemental oxygen in the two groups of treatment. | | | | Yes | False | | |
| JPRN-UMIN000040656 | 11 August 2020 | Multicenter registry study of Japanese patients with inflammatory bowel disease with COVID-19 | Multicenter registry study of Japanese patients with inflammatory bowel disease with COVID-19 - Japan COVID-19 surveillance in inflammatory bowel disease (J-COSMOS) | | Department of Gastroenterology and Hepatology, Sapporo Medical University School of Medicine | 01/08/2020 | 20200801 | JPRN | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046390 | Not Recruiting | No | Not applicable | Not applicable | Male and Female | 2020/08/01 | 200 | Observational | Not selected Not selected | Not applicable | Japan | DAISUKE | HIRAYAMA | South 1 West 16, Chuo-ku, Sapporo, 060-8543, Japan | hirarin95@yahoo.co.jp | 011-611-2111 | Sapporo Medical University School of Medicine Department of Gastroenterology and Hepatology | Inclusion criteria: | Exclusion criteria: Those who refused to participate in the study by opr-out | inflammatory bowel disease
COVID-19 | | The rate of Japanese IBD patients with COVID-19 | | 31/03/2022 | | Yes | False | | |
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| ChiCTR2000029822 | 17 August 2020 | A randomized controlled trial for honeysuckle decoction in the treatment of patients with novel coronavirus (COVID-19) infection | A randomized controlled trial for honeysuckle decoction in the treatment of patients with novel coronavirus (COVID-19) infection | | Nanjing Second Hospital | 2020-02-14 | 20200214 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=49502 | | No | 0 | 100 | Both | 2020-02-07 | Experimental group:70;Control group:40; | Interventional study | Parallel | 0 | China | Yongxiang Yi | | 1 Kangfu Road, Tangshan Street, Jiangning District, Nanjing, China | ian0126@126.com | +86 13338628626 | Nanjing Second Hospital | Inclusion criteria: 1. Age is not limited;
<br>2. Clinical diagnosis is in accordance with the "Notice on issuing a new type of coronavirus pneumonia diagnosis and treatment program (Fifth edition)" on the diagnosis of a new type of coronavirus infection;
<br>3. potable decoction;
<br>4. no honeysuckle allergy;
<br>5. child-bearing age female subjects pregnancy test negative person;
<br>6. child-bearing age female subjects pregnancy test positive person needs targeted communication, the patient's consent can be included;
<br>7. pregnancy or breast-feeding subjects need targeted communication, the patient's consent can be included in the voluntary informed consent signed by the person under the age of 16. | Exclusion criteria: (1) Those who cannot take Chinese traditional medicine decoction;
<br>(2) mentally ill subjects who are not easy to control;
<br>(3) those who are pregnant or breast-feeding;
<br>(4) those who use other Chinese medicines;
<br>(5) those who are not considered suitable to participate in this trial by researchers. | Novel Coronavirus Pneumonia (COVID-19) | Experimental group:honeysuckle decoction;Control group:placebo; | rate of cure; | | | | No | False | | |
| → | ISRCTN17717312 | 17 August 2020 | CORONATION: Coronavirus (COVID-19) multinational observational registry | Coronavirus (COVID-19) Multinational observational registry (CORONATION) | | Cambridge University Hospitals NHS Foundation Trust | 23/07/2020 | 20200723 | ISRCTN | http://isrctn.com/ISRCTN17717312 | Recruiting | No | | | Both | 30/07/2020 | 10000 | Observational | Observational epidemiological study (Screening) | Not Applicable | Bermuda;Bhutan;Bolivia;Bonaire Saint Eustatius and Saba;Bosnia and Herzegovina;Botswana;Bouvet Island;Brazil;British Indian Ocean Territory;Brunei;Bulgaria;Burkina Faso;Burundi;Cambodia;Cameroon;Canada;Cape Verde;Cayman Islands;Central African Republic;Chad;Chile;China;Christmas Island;Benin;Belize;Belgium;Belarus;Barbados;Bangladesh;Bahrain;Bahamas;Azerbaijan;Austria;Australia;Aruba;Armenia;Argentina;Antigua and Barbuda;Antarctica;Anguilla;Angola;Andorra;American Samoa;Algeria;Albania;Aland Islands;Afghanistan;Cocos (Keeling) Islands;Faroe Islands;Fiji;Finland;France;French Guiana;French Polynesia;French Southern Territories;Gabon;Gambia;Georgia;Germany;Ghana;Gibraltar;Greece;Greenland;Grenada;Guadeloupe;Guam;Guatemala;Colombia;Comoros;Congo;Congo, Democratic Republic;Cook Islands;Costa Rica;Cote d'Ivoire;Croatia;Cuba;Curacao;Cyprus;Czech Republic;Denmark;Djibouti;Dominica;Dominican Republic;Ecuador;Egypt;El Salvador;Equatorial Guinea;Eritrea;Estonia;Ethiopia;Falkland Islands;Guernsey;Kiribati;Korea, North;Korea, South;Kosovo;Kuwait;Kyrgyzstan;Laos;Latvia;Lebanon;Lesotho;Liberia;Guinea;Guinea-Bissau;Guyana;Haiti;Heard Island and Mcdonald Islands;Holy See (Vatican City State);Honduras;Hong Kong;Hungary;Iceland;India;Indonesia;Iran;Iraq;Ireland;Isle of Man;Israel;Italy;Jamaica;Japan;Jersey;Jordan;Kazakhstan;Kenya;Libya;Mozambique;Myanmar;Namibia;Nauru;Nepal;Netherlands;Netherlands Antilles;New Caledonia;New Zealand;Nicaragua;Niger;Nigeria;Liechtenstein;Lithuania;Luxembourg;Macao;Macedonia;Madagascar;Malawi;Malaysia;Maldives;Mali;Malta;Marshall Islands;Martinique;Mauritania;Mauritius;Mayotte;Mexico;Micronesia, Federated States of;Moldova;Monaco;Mongolia;Montenegro;Montserrat;Morocco;Niue;Saint Lucia;Saint Martin (French part);Saint Pierre and Miquelon;Saint Vincent and the Grenadines;Samoa;San Marino;Sao Tome and Principe;Saudi Arabia;Norfolk Island;Northern Mariana Islands;Norway;Oman;Pakistan;Palau;Palestinian Territory;Panama;Papua New Guinea;Paraguay;Peru;Philippines;Pitcairn;Poland;Portugal;Puerto Rico;Qatar;Reunion;Romania;Russian Federation;Rwanda;Saint Barthelemy;Saint Helena;Saint Kitts and Nevis;Senegal;Thailand;Timor-Leste;Togo;Tokelau;Tonga;Trinidad and Tobago;Tunisia;Turkey;Turkmenistan;Turks and Caicos Islands;Tuvalu;Serbia;Seychelles;Sierra Leone;Singapore;Sint Maarten (Dutch part);Slovakia;Slovenia;Solomon Islands;Somalia;South Africa;South Georgia and the South Sandwich Is;South Sudan;Spain;Sri Lanka;Sudan;Suriname;Svalbard and Jan Mayen;Swaziland;Sweden;Switzerland;Syria;Taiwan;Tajikistan;Tanzania;Uganda;Ukraine;United Arab Emirates;United States Minor Outlying Islands;United States of America;Uruguay;Uzbekistan;Vanuatu;Venezuela;Viet Nam;Virgin Islands, British;Virgin Islands, U.S.;Wallis and Futuna;Western Sahara;Yemen;Zambia;Zimbabwe→Bermuda;Bhutan;Bolivia;Bonaire Saint Eustatius and Saba;Bosnia and Herzegovina;Botswana;Bouvet Island;Brazil;British Indian Ocean Territory;Brunei;Bulgaria;Burkina Faso;Burundi;Cambodia;Cameroon;Canada;Cape Verde;Cayman Islands;Central African Republic;Chad;Chile;China;Christmas Island;Benin;Belize;Belgium;Belarus;Barbados;Bangladesh;Bahrain;Bahamas;Azerbaijan;Austria;Australia;Aruba;Armenia;Argentina;Antigua and Barbuda;Antarctica;Anguilla;Angola;Andorra;American Samoa;Algeria;Albania;Aland Islands;Afghanistan;Cocos (Keeling) Islands;Faroe Islands;Fiji;Finland;France;French Guiana;French Polynesia;French Southern Territories;Gabon;Gambia;Georgia;Germany;Ghana;Gibraltar;Greece;Greenland;Grenada;Guadeloupe;Guam;Guatemala;Guernsey;Guinea;Guinea-Bissau;Guyana;Haiti;Heard Island and Mcdonald Islands;Holy See (Vatican City State);Honduras;Hong Kong;Hungary;Iceland;India;Indonesia;Colombia;Comoros;Congo;Congo, Democratic Republic;Cook Islands;Costa Rica;Cote d'Ivoire;Croatia;Cuba;Curacao;Cyprus;Czech Republic;Denmark;Djibouti;Dominica;Dominican Republic;Ecuador;Egypt;El Salvador;Equatorial Guinea;Eritrea;Estonia;Ethiopia;Falkland Islands;Iran;Iraq;Ireland;Isle of Man;Israel;Italy;Jamaica;Japan;Jersey;Jordan;Kazakhstan;Kenya;Kiribati;Korea, North;Korea, South;Kosovo;Kuwait;Kyrgyzstan;Laos;Latvia;Lebanon;Lesotho;Liberia;Libya;Liechtenstein;Lithuania;Luxembourg;Macao;Macedonia;Madagascar;Malawi;Malaysia;Maldives;Mali;Malta;Marshall Islands;Martinique;Mauritania;Mauritius;Mayotte;Mexico;Micronesia, Federated States of;Moldova;Monaco;Mongolia;Montenegro;Montserrat;Morocco;Mozambique;Myanmar;Namibia;Nauru;Nepal;Netherlands;Netherlands Antilles;New Caledonia;New Zealand;Nicaragua;Niger;Nigeria;Niue;Norfolk Island;Northern Mariana Islands;Norway;Oman;Pakistan;Palau;Palestinian Territory;Panama;Papua New Guinea;Paraguay;Peru;Philippines;Pitcairn;Poland;Portugal;Puerto Rico;Qatar;Reunion;Romania;Russian Federation;Rwanda;Saint Barthelemy;Saint Helena;Saint Kitts and Nevis;Saint Lucia;Saint Martin (French part);Saint Pierre and Miquelon;Saint Vincent and the Grenadines;Samoa;San Marino;Sao Tome and Principe;Saudi Arabia;Senegal;Serbia;Seychelles;Sierra Leone;Singapore;Sint Maarten (Dutch part);Slovakia;Slovenia;Solomon Islands;Somalia;South Africa;South Georgia and the South Sandwich Is;South Sudan;Spain;Sri Lanka;Sudan;Suriname;Svalbard and Jan Mayen;Swaziland;Sweden;Switzerland;Syria;Taiwan;Tajikistan;Tanzania;Thailand;Timor-Leste;Togo;Tokelau;Tonga;Trinidad and Tobago;Tunisia;Turkey;Turkmenistan;Turks and Caicos Islands;Tuvalu;Uganda;Ukraine;United Arab Emirates;United States Minor Outlying Islands;United States of America;Uruguay;Uzbekistan;Vanuatu;Venezuela;Viet Nam;Virgin Islands, British;Virgin Islands, U.S.;Wallis and Futuna;Western Sahara;Yemen;Zambia;Zimbabwe | Kerrie | Brusby |
Cambridge Clinical Trials Centre (CCTU)
Cambridge University Hospitals (CUH) NHS Foundation Trust
Addenbrooke’s Hospital
Cambridge Biomedical Campus
Box 4 | add-tr.coronation@nhs.net | +44 (0)1223254472 | | Inclusion criteria: <br> All COVID-19 cases are eligible for inclusion (COVID-19 cases that pre-decease the start of the registry are eligible)<br> | Exclusion criteria: Does not meet inclusion criteria | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> The CORONATION registry is a patient-level disease registry capturing identifiable patient data on UK COVID-19 cases and anonymised or identifiable data on international COVID-19 cases.<br><br> Care teams will collect demographic and clinical data on confirmed COVID-19 cases and enter this information into a database. This will be undertaken through a simple enrollment process and linkage with other datasets.<br><br> Baseline data collected will include baseline demographic data, baseline clinical data (comorbidities, medication, COVID-19 status and symptoms).<br> | Demographic and clinical data on confirmed COVID-19 cases (comorbidities, medication, COVID-19 status and symptoms) collected regularly from participating centres by entering data into an online portal | | 24/04/2025 | | Yes | False | | |
| ISRCTN60069084 | 17 August 2020 | Effect of N-acetylcysteine on COVID-19 treatment | Inflammatory regulation effect of N-acetylcysteine on COVID-19 treatment, pilot, double blinded randomized placebo controlled multicenter clinical trial | | King Saud Medical City | 19/07/2020 | 20200719 | ISRCTN | http://isrctn.com/ISRCTN60069084 | Recruiting | No | | | Both | 01/09/2020 | 1180 | Interventional | Adaptive pilot double-blinded randomized placebo-controlled multi-center clinical trial (Treatment) | Phase III/IV | Oman;Saudi Arabia | | | | | | | Inclusion criteria: <br> 1. Adults (above 18 years)<br> 2. Admitted to the hospital<br> 3. Confirmed COVID-19 patient by RT-PCR test from any specimen (nasal, throat swab, sputum, etc)<br> 4. On oxygen supplement ( Category 4, 5, 6, 7 on the ordinal scale)<br> | Exclusion criteria: <br> 1. Active indication and use of NAC<br> 2. Known allergy to NAC<br> 3. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of provision of treatment e.g. patients on ECMO at time of randomization<br> 4. Patients enrolled in other investigational drug studies are not eligible for our study<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> Randomization will be stratified by:<br> 1. Center<br> 2. COVID-19 clinical severity stage<br> Allocation to the intervention group and the control group will be in a 1:1 ratio. Randomization will be blocked in a randomly permuted block size.<br><br> The intervention group will receive N-Acetylcysteine (NAC) 150 mg/kg every 12 hours for 14 days of admission in addition to the standard of care.<br> The primary route is oral, but the treating team has the option to start or switch to IV Infusion over 1 hour if:<br> 1. The patient can’t tolerate orally.<br> 2. The patient is in shock and gastrointestinal absorption is thought to be impaired.<br><br> The control group will receive matching normal saline placebo administered in the same schedule and volume as NAC in addition to the standard of care implemented in the hospitals for COVID-19 management.<br><br> Participants will be followed until they are discharged. No specific laboratory/radiological investigation is required. The result of their usual lab, symptoms progression, clinical severity and outcomes will be collected on a daily basis during hospitalization until discharge.<br> | <br> Time to recovery: day of recovery is defined as the first day on which one of the following three categories from the Ordinal scale on clinical improvement per WHO blueprint in COVID-19 therapeutic trials:<br> 1. Hospitalized, not requiring supplemental oxygen<br> 2. Not hospitalized, limitation on activities and/or requiring home oxygen<br> 3. Not hospitalized, no limitations on activities<br> Measured using patient’s medical records until discharge<br> | | 01/10/2021 | | Yes | False | | |
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| ISRCTN60400862 | 17 August 2020 | Evaluation of a COVID-19 antibody test: What is the performance of the Panbio™ COVID-19 IgG/IgM rapid test device in fingerstick blood, venous whole blood, serum and plasma in adult participants? | Panbio™ COVID-19 IgG/IgM rapid test device matrix equivalence study: evaluating test performance in comparison with a laboratory reference method using venous whole blood, serum and plasma as well as capillary whole blood from adult participants | | Abbott (Germany) | 22/06/2020 | 20200622 | ISRCTN | http://isrctn.com/ISRCTN60400862 | Not Recruiting | No | | | Both | 15/05/2020 | 206 | Observational | Observational case-control study (Diagnostic) | Not Applicable | United Kingdom | | | | | | | Inclusion criteria: <br> 1. Aged 18 years or older<br> 2. Known to have been infected with SARS-CoV-2, or who have not been infected with SARS-CoV-2<br> 3. Agrees to complete all aspects of the study<br> | Exclusion criteria: <br> 1. Belongs to a study group that has been filled<br> 2. Has already participated in this study on a previous occasion<br> 3. Is enrolled in a study to evaluate a new drug<br> 4. Unable or unwilling to provide informed consent<br> 5. Is a vulnerable person as deemed unfit for the study by the Principal Investigator<br> | COVID-19 (SARS-CoV-2 infection) past exposure <br>Infections and Infestations | All participants provided a fingerstick capillary whole blood sample as well as a venous blood sample. All participants had a fingerstick capillary whole blood sample, a venous EDTA whole blood sample, a venous EDTA plasma sample and a venous serum sample tested using the Panbio COVID-19 IgG/IgM Rapid Test Device. The results are evaluated using laboratory based SARS-CoV-2 IgM and IgG reference tests. | User’s test result interpretation of the Panbio™ COVID-19 IgG/IgM rapid test device at 10 minutes and at 20 minutes after sample application, using fingerstick whole blood, venous whole blood and venous serum, in comparison with venous plasma | | 03/07/2020 | | No | False | | |
| → | ISRCTN13694948 | 17 August 2020 | Distress and resilience of healthcare professionals during the COVID-19 (coronavirus) pandemic | Distress And Resilience of healthcare professionals during the COVID-19 pandemic | | University Hospital of Bern | 01/04/2020 | 20200401 | ISRCTN | http://isrctn.com/ISRCTN13694948 | Recruiting | No | | | Both | 02/04/2020 | 400 | Observational | Mixed-methods observational (Other) | Not Applicable | New Zealand;Norway;Portugal;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States of America;Netherlands;Malta;Luxembourg;Lithuania;Liechtenstein;Lebanon;Italy;Israel;Isle of Man;Ireland;Greece;Germany;French Southern Territories;France;Finland;Denmark;Czech Republic;Cyprus;Croatia;Bulgaria;Brazil;Belgium;Austria;Australia→Australia;Austria;Belgium;Brazil;Bulgaria;Croatia;Cyprus;Czech Republic;Denmark;Finland;France;French Southern Territories;Germany;Greece;Ireland;Isle of Man;Israel;Italy;Lebanon;Liechtenstein;Lithuania;Luxembourg;Malta;Netherlands;New Zealand;Norway;Portugal;Slovakia;Slovenia;South Africa;Spain;Sweden;Switzerland;Turkey;United Kingdom;United States of America | | | | | | | Inclusion criteria: <br> 1. Healthcare professionals<br> 2. >18 years of age<br> 3. Willing to participate<br> | Exclusion criteria: Does not meet inclusion criteria | Individual resilience and work sense of coherence and the development of mental symptoms during a pandemic scenario <br>Not Applicable | <br> Matched longitudinal internet-based survey with pre-existing, validated self-questionnaires (Work-SoC, PHQ-9, IES-6, PVD, SFI, CD-RISC 10), at 3 time periods of 2 weeks over 6 months, with the option to prolong depending on the development of the pandemic.<br><br> Semi-structured interviews with focus groups after the last period of the survey.<br> | COVID-19 Anxiety (adapted SARS-Anxiety-Scale) at 3 time periods of 2 weeks over 6 months | | 01/01/2021 | | Yes | False | | |
| IRCT20180725040596N2 | 17 August 2020 | Effect of Arbidol in treatment of COVID-19 | Evaluation of the effect of Arbidol drug in the treatment of hospitalized patients with COVID-19 | | Iran University of Medical Sciences | 2020-04-18 | 20200418 | IRCT | http://en.irct.ir/trial/46897 | Recruiting | No | 18 years | no limit | Both | 2020-04-29 | 100 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Method: Simple randomization.
Unit: Individual.
Tools: Random blocks
How to build: Using 4 times Blocks (AABB, ABAB, ....) with random selection of block and reading from right to left
Allocation concealment will be done by numbered drug cans that are numbered randomly. The cans will be the same weight and shape and will be prepared by an independent researcher. | 3 | Iran (Islamic Republic of) | ?Dr. Mitra Ranjbar | | Firoozgar hospital., Beh Afarin Ave., Karimkhan Ave., Valiasr Sq | mitrearanjbar@yahoo.com | +98 21 8214 1201 | Iran University of Medical Sciences | Inclusion criteria: Age equal or greater than 18 years<br>Signing informed consent<br>Diagnosis of COVID-19 by chest CT-scan or RT-PCR test | Exclusion criteria: Respiratory failure<br>People with a history of allergies to this drug and or a history of severe allergies<br>Patients who used Arbidol (Tablets, capsules, granules) before hospitalization<br>Women who are breastfeeding or pregnant<br>Renal or liver function failure<br>Anemia or thrombocytopenia<br>Patient who received immunosuppressive drug during 3 months ago<br>Congenital heart failure<br>History of arrhythmia<br>coagulation disorders | COVID-19. <br>Coronavirus infection, unspecified;U07.1 | Intervention 1: Intervention group: 50 patients with COVID-19 will be included in this group and their treatment regimen includes oral Hydroxychloroquine (first day 400 mg/BD and from second day 200 mg/BD) and Arbidol orally at a dose of 200 mg 3 times a day for 5 to 10 days. Intervention 2: Control group: Fifty COVID-19 patients in the control group will be given a treatment regimen of two Kaletra 200/50 mg tablets every 12 hours and Hydroxychloroquine sulfate (single dose 400 mg/ BD for first day) for 5 to 10 days. | Hospital admission days. Timepoint: check daily. Method of measurement: observation.;Measurement of blood oxygen saturation and no adjuvant oxygen therapy. Timepoint: Measurement of oxygen saturation level at the beginning of the study and 7 days after starting treatment. Method of measurement: Pulse oximeter.;Chest CT Scan view symptoms. Timepoint: Patient's chest CT scan check at the beginning of the study and 30 days after starting treatment. Method of measurement: Taking a chest CT scan.;Determination of C-reactive protein test. Timepoint: Measurement of C-reactive protein level at the beginning of the study and 7 days after starting treatment. Method of measurement: Blood test.;Measurement of complete blood count test. Timepoint: Performing a complete blood cell count test at the beginning of the study and 7 days after starting treatment. Method of measurement: Blood test.;Measurement of patients fever. Timepoint: Measurement of patient's body temperature at the beginning of the study and 7 days after starting treatment. Method of measurement: Thermometer. | | | | Yes | False | | |
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| IRCT20170117032025N7 | 17 August 2020 | Effectiveness of Mouthwashes in Early Reducing the mouth Viral Load Among COVID-19 Patients | Evaluation of the Effectiveness of Mouthwashes in Early Reducing the mouth Viral Load Among COVID-19 Patients: A double-blind randomized clinical trial | | Hamedan University of Medical Sciences | 2020-07-12 | 20200712 | IRCT | http://en.irct.ir/trial/49534 | Recruiting | No | 18 years | 70 years | Both | 2020-07-11 | 60 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We prepare four sheets of paper and write on one sheet the letter P meaning Povidone-iodine, O meaning hydrogen peroxide, C meaning Cetylpyridinium, and N meaning normal saline. Mix the sheets and place them in the desk drawer. Upon referral to each of the eligible patients, one of the sheets will be randomly removed and assigned to one of the three intervention or control groups, and this will continue until the sample size is completed, Blinding description: All four groups will receive a mouthwash with the same appearance, which is marked with a code, and the patient and the person responsible for RT-PCR testing and the person responsible for collecting the type of drug used by the patient will be unaware. | 3 | Iran (Islamic Republic of) | Dr Ali Heidari | | Shahid Fahmideh street | aliheidari55@gmail.com | +98 81 3525 0182 | Hamedan University of Medical Sciences | Inclusion criteria: Clinical diagnosis of COVID-19 infection based on the opinion of the treating physician based on national guidelines<br>Patients with mild to moderate disease | Exclusion criteria: Patients with previous underlying oral disease<br>Patients with inability to properly perform the mouthwash protocol<br>Patients with thyroid disorders | Early reduction in COVID-19 viral load. <br>Other and unspecified parts of mouth;D10.3 | Intervention 1: Intervention group: In intervention group 1, patients will gargle and rinse 20 cc of 2% Povidone-iodine mouthwash in the mouth for 20 seconds. Intervention 2: Intervention group: In intervention group 2, patients will gargle and rinse 20 cc of 1% hydrogen peroxide mouthwash for 20 seconds in the mouth. Intervention 3: In intervention group 3, patients will gargle and rinse 20 cc of Cetylpyridinium chloride mouthwash for 20 seconds. Intervention 4: Control group: In the patient control group, 20 cc of normal saline mouthwash will be gargled and rinsed inside the mouth for 20 seconds. | Early reduction of viral load in the mouth of COVID-19 patients. Timepoint: A sample of oropharyngeal swap will be taken from patients to check for viral load before intervention. Patients then use 20 cc of the appropriate mouthwash, based on the assigned group, which will be practically taught by the researcher on how to use it. After 30 minutes from the beginning of the intervention, the second sample of oropharyngeal swap will be determined to determine the virus load. After preparation, all samples will be placed in a tube containing a special medium for transmission (VTM) and will be transferred to the specialized reference laboratory COVID-19 of Hamadan University of Medical Sciences to determine the load of the virus by standard RT-PCR method. Method of measurement: A sample of an oropharyngeal swap will be taken from patients to check for viral load before intervention. After 30 minutes from the start of the intervention, a second oropharyngeal swap will be performed to determine the virus load. | | | | No | False | | |
| → | IRCT20190415043279N6 | 17 August 2020 | Evaluation of the effect of Afsantin on COVID 19 | Evaluation of the effect of Afsantin in the treatment of COVID 19 patients | | Sanandaj University of Medical Sciences | 2020-07-24 | 20200724 | IRCT | http://en.irct.ir/trial/49544 | Recruiting | No | no limit | no limit | Both | 2020-07-10 | 80 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using block randomization method with a block size of 4. Sampling method at this study will be according to random allocation. Participants will enter the study according to inclusion criteria, and then will be divided into two groups according to randomization table. One group will receive Afsantin Capsule and the other will receive placebo. The participants and administrator do not have any information about content of capsules (double blinded study). The list of randomization was computer-generated. supplements and placebo capsules were placed in completely identical packages and were coded by someone who was unaware of the nature of the study in numbered bottles based on the list. And another person who was unaware of the contents of the pack provided them to the patients, Blinding description: All supplements and placebo capsules were identi | 3 | Iran (Islamic Republic of) | Noshad Mohammadi | | Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran | noshad.50@gmail.com | +98 87 3366 4645 | Sanandaj University of Medical Sciences | Inclusion criteria: Definitive confirmation of Covid 19 based on RT-PCR results<br>Hospitalized patients<br>Ventilator independent patients | Exclusion criteria: Pregnancy<br>Breastfeeding<br>Diabetes<br>Severe renal failure<br>Metabolic acidosis<br>Severe respiratory failure<br>Taking anticoagulants | Covid-19. <br>Other coronavirus as the cause of diseases classified elsewhere;U07.1 | Intervention 1: Intervention group: The Afsantin capsule is taken as a 1000 mg soft capsule four times a day for 14 days. Intervention 2: Control group: The placebo is taken as a capsule four times a day for 14 days. | Fever. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Thermometer.;Heart Rate. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Pulse oximeter.;Respiratory Rate. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: By observing the occurrence of breaths.;CBC. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Cell Counter.;Blood oxygen saturation percentage. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Pulse oximeter.;C Reactive Protein (CRP). Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Agglutination.;Muscle pain. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Questionnaire.;Cough. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Questionnaire.→Fever. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Thermometer.;Cough. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Questionnaire.;Muscle pain. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Questionnaire.;C Reactive Protein (CRP). Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Agglutination.;Blood oxygen saturation percentage. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Pulse oximeter.;CBC. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Cell Counter.;Respiratory Rate. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: By observing the occurrence of breaths.;Heart Rate. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Pulse oximeter. | | | | No | False | | |
| IRCT20200426047206N3 | 17 August 2020 | The effect of Cyclosporine in prognosis and clinical improvement in patients with COVID-19 | Evaluating the effect of Cyclosporine in prognosis and clinical improvement in patients with COVID-19: A Randomized Clinical Trial Study | | Hamedan University of Medical Sciences | 2020-07-21 | 20200721 | IRCT | http://en.irct.ir/trial/49579 | Recruiting | No | 18 years | 60 years | Both | 2020-07-22 | 48 | interventional | Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For this purpose, we will use the BalancedBlock Randomization method (block size=4). Random allocation software will be used for this purpose. At first, we prepare two sheets of paper. We write "Intervention" on a paper and "Standard treatment" on another. Mix the sheets together and place them on the desk drawer. With the referral of each of the eligible patients, one of the cards will be drawn randomly and based on this drawn card, it will be assigned to one of the two groups. It should be noted that the drawn sheets will not be returned to the drawer until all four sheets have been removed. After all four sheets are drawn randomly, all the sheets are returned to the drawer and the above operation will be continued for the next four patients until the desired sample size is reached, Blinding description: We describe two treatment groups for | 3 | Iran (Islamic Republic of) | Salman Khazaei | | Fahmideh | salman.khazaei61@gmail.com | +98 81 3838 0548 | Hamedan University of Medical Sciences | Inclusion criteria: Positive PCR test<br>Age between 18-60 years<br>patient with acute respiratory infectious symptoms and lung involvement<br>non-intubated patients | Exclusion criteria: Allergy to Cyclosporin<br>Not willing to participate<br>Patients with cancer<br>Under treatment with immunosuppressor drugs<br>Pregnancy or breastfeeding | COVID-19 disease. <br>COVID-19;U07.1 | Intervention 1: Intervention group: Patients receive low-dose cyclosporine for at least 7 days orally.Also, the routine treatments (The last national protocol for COVID-19 treatment) will be given to patients according to the physician's supervision. Intervention 2: Control group: The routine treatments (The last national protocol for COVID-19 treatment) will be given to these patients according to the physician's supervision. | Change oxygenation. Timepoint: Daily for two weeks. Method of measurement: pulse oximeter.;Creatinine clearance status. Timepoint: Days 2, 4 and 6. Method of measurement: laboratory exam.;Inflammatory factors. Timepoint: Days 1 and 7. Method of measurement: Flow Cytometry.;Number of days hospitalized in the ward. Timepoint: Seventh day onward. Method of measurement: day.;Serum D.dimer. Timepoint: Days 1,3 and 7. Method of measurement: Enzymes.;Serum ferritin level. Timepoint: Days 1,3 and 7. Method of measurement: laboratory test.;TCD4+, TCD8+, B Cell. Timepoint: Days 1 and 7. Method of measurement: Flow Cytometry.;CRP. Timepoint: Days 1 and 7. Method of measurement: mg/L. | | | | Yes | False | | |
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| KCT0005226 | 18 August 2020 | Clinical characteristics and disease progression in early-stage COVID-19 patients in South Korea | Clinical characteristics and disease progression in early-stage COVID-19 patients in South Korea | | Yonsei University Health System, Gangnam Severance Hospital | 2020-07-13 | 20200713 | CRIS | http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=16997 | Not Recruiting | No | 18(Year) | No Limit | Both | 2020-03-23 | 293 | Observational Study | Observational Study Model : Cohort, Time Perspective : Retrospective, Enrollment : 293, Biospecimen Retention : Not collect nor Archive | NA | Korea, Republic of | Min Hyuk | Choi | | | | Yonsei University Health System, Gangnam Severance Hospital | Inclusion criteria: All consecutive patients with confirmed COVID-19 admitted to the Armed Forces Daegu Hospital, Daegu, South Korea, from March 5, 2020, to March 18, 2020, were enrolled in this study. | Exclusion criteria: none | ;Certain infectious and parasitic diseases | | Whether symptoms aggravated (including radiological and/or clinical findings) | 13/07/2020 | | http://cris.nih.go.kr/cris/files/cris/1592961000354.pdf | No | False | | Yes |
| → | EUCTR2020-001333-13-FR | 18 August 2020 | Dexamethasone associated with hydroxychloroquine vs. hydroxychloroquine alone for the early treatment of severe ARDS caused by COVID-19 : a randomized controlled trial | Dexamethasone associated with hydroxychloroquine vs. hydroxychloroquine alone for the early treatment of severe ARDS caused by COVID-19 : a randomized controlled trial - DHYSCO | | Groupe Hospitalier Paris Saint-Joseph | 02/04/2020 | 20200402 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001333-13 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 09/04/2020 | 122 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Dexamethasone associated with hydroxychloroquine will be compared to hydroxychloroquine alone
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| France | Clinical research project manager | | 133 Avenue de la résistance | l.lamrani@hml.fr | 0033140942554 | Groupe Hospitalier Paris Saint Joseph - Hôpital Marie Lannelongue | Inclusion criteria: <br>1. Patient aged > 18<br>2. Patient affiliated to a health insurance plan<br>3. Patient who has given their free, informed and written consent or patient for whom an independent doctor has given their signed consent as part of an emergency procedure<br>4. Serum Potassium> 3,5 mmol / L<br>5. Patient diagnosed COVID positive by RT-PCR and / or scanner<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 80<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 42<br> | Exclusion criteria: <br>1. Patient under guardianship or curatorship<br>2. Patient with plausible alternate diagnosis<br>3. ARDS evolving for more than 4 days<br>4. Contraindication to the HCQ<br>5. Contraindication to DXM<br>6. Uncontrolled septic shock<br>7. Untreated active infection or treated less than 24 hours<br>8. Long-term patient treated with corticosteroids (> 20 mg / day) or HCQ<br>9. Immunocompromised patients: AIDS, bone marrow or solid organ transplant recipients<br>10. Pregnant women<br> | Acute Respiratory Distress Syndrome (ARDS) caused by SARS-Cov-2 infection;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: DEXAMETHASONE MYLAN 20mg/5mL <br>Product Name: DEXAMETHASONE<br>Pharmaceutical Form: Injection<br><br>Trade Name: PLAQUENIL 200MG<br>Product Name: HYDROXYCHLOROQUINE<br>Pharmaceutical Form: Tablet<br><br> | Main Objective: Assess, in patients with ARDS caused by COVID-19, the efficacy of dexamethasone (DXM) associated with hydroxychloroquine (HCQ) compared to HCQ alone on mortality at 28 days;Timepoint(s) of evaluation of this end point: the 28th day after the start of treatment<br>;Primary end point(s): Mortality on D28<br>;Secondary Objective: Assess, in patients with ARDS causedd by COVID-19, the efficacy of DXM associated with HCQ compared to HCQ alone on :<br>- the ventilator-free days<br>- mortality in intensive care unit<br>- mortality on D60<br>- the occurrence of infectious complications →Main Objective: Assess, in patients with ARDS caused by COVID-19, the efficacy of dexamethasone (DXM) associated with hydroxychloroquine (HCQ) compared to HCQ alone on mortality at 28 days;Primary end point(s): Mortality on D28<br>;Secondary Objective: Assess, in patients with ARDS causedd by COVID-19, the efficacy of DXM associated with HCQ compared to HCQ alone on :<br>- the ventilator-free days<br>- mortality in intensive care unit<br>- mortality on D60<br>- the occurrence of infectious complications ;Timepoint(s) of evaluation of this end point: the 28th day after the start of treatment<br> | | | | Yes | False | | |
| EUCTR2020-001739-28-BE | 18 August 2020 | A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19.
| A randomized, open-label, adaptive, proof-of-concept clinical trial of modulation of host thromboinflammatory response in patients with COVID-19.
- DAWN AntiCo | | UZLeuven | 10/04/2020 | 20200410 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001739-28 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 20/05/2020 | 210 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: best practice
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Belgium | Caroline Devooght | | Herestraat 49 | caroline.devooght@uzleuven.be | | UZ Leuven | Inclusion criteria: <br>1. Subject (=18 years old) or legally authorized representative provides informed consent prior to initiation of any study procedures. When signed informed consent is not possible (e.g. due to restrictions to prevent viral transmission), verbal informed consent in the presence of a witness will be obtained and documented in the medical files. Signed informed consent will be obtained as soon as the safety concerns are mitigated.
<br>
<br>2. Subject (or legally authorized representative) understands and agrees to comply with planned study procedures.
<br>
<br>3. Male or non-pregnant female adult =18 years of age at time of enrolment.
<br>
<br>4. Has a confirmed diagnosis of SARS-CoV-2 infection, defined as either:
<br>a. laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or public health assay in any specimen as diagnosed within 72 hours prior to randomization
<br>or
<br>b. The combination of upper or lower respiratory infection symptoms (fever, cough, dyspnea, desaturation) and typical findings on chest CT scan and absence of other plausible diagnoses
<br>
<br>5. Illness of any duration, and at least one of the following:
<br>a. Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), or
<br>b. Clinical assessment (evidence of rales/crackles on lung auscultation) AND SpO2 = 94% on room air, or
<br>c. Requiring mechanical ventilation and/or supplemental oxygen.
<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 105<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 105<br> | Exclusion criteria: <br>1. ALT/AST > 8 times the upper limit of normal.
<br>
<br>2. Pregnancy or breastfeeding.
<br>
<br>3. Allergy to any study medication.
<br>
<br>4. Any medical condition which would impose an unacceptable safety hazard by participation in the study.
<br>
<br>5. Study drug-specific exclusion criteria:
<br>
<br>• For Aprotinin:
<br>o Known active thromboembolic disease, defined as a history of idiopathic (unprovoked) deep vein thrombosis or pulmonary embolism, recent (<3m) deep vein thrombosis or pulmonary embolism, recent (<6m) myocardial infarction or coronary stenting, recent (<6m) ischemic stroke
<br>o Renal insufficiency with CrCl <30ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis
<br>o Recent (<6m) cardiac surgery with cardiopulmonary bypass and/or use of aprotinin
<br>
<br>• For LMWH:
<br>o Active bleeding, a history of intracranial bleeding, or a recent (<3m) GI bleeding requiring transfusion and/or intervention, recent surgery in the central nervous system
<br>o Renal insufficiency with CrCl < 20ml/min or continuous renal replacement therapy, hemodialysis, or peritoneal dialysis
<br>o Blood platelet count < 30 000/µL
<br>o Other conditions that are judged to carry an increased risk of bleeding as judged by the investigator
<br>o Need for therapeutic anticoagulation (known active thrombo-embolic diseases, atrial fibrillation, mechanical prosthetic heart valve,…)
<br>
<br>• For Anakinra:
<br>o Impairment of cardiac function defined as severe heart failure, unstable angina pectoris, myocardial infarction within 6 months before enrollment, ventricular arrhythmia requiring treatment or intervention.
<br>o Severe renal dysfunction (creatinine clearance = 20mL/min) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
<br>o Uncontrolled hypertension (persistent systolic blood pressure >180mmHg, or diastolic blood pressure >110mmHg)
<br>o Clinical suspicion of latent tuberculosis
<br>o Clinical suspicion of severe bacterial surinfection (e.g. ventilator-associated pneumonia)<br> | COVID-19 <br>MedDRA version: 20.0
Level: LLT
Classification code 10038700
Term: Respiratory infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Aprotinin<br>Pharmaceutical Form: Infusion<br>INN or Proposed INN: APROTININ<br>CAS Number: 9087-70-1<br>Other descriptive name: APROTININ<br><br>Product Name: Anakinra<br>Pharmaceutical Form: Infusion<br>INN or Proposed INN: ANAKINRA<br>CAS Number: 143090-92-0<br><br>Product Name: Enoxaparin<br>Pharmaceutical Form: Injection<br>INN or Proposed INN: ENOXAPARIN<br>CAS Number: 9005-49-6<br>Other descriptive name: ENOXAPARIN<br><br>Product Name: Nadroparin<br>Pharmaceutical Form: Injection<br>INN or Proposed INN: NADROPARIN<br>Current Sponsor code: NADROPARIN<br><br> | Main Objective: The overall objective of the study is to evaluate the clinical efficacy and safety of different investigational therapeutics relative to the standard of care in patients hospitalized with COVID-19.;Timepoint(s) of evaluation of this end point: Day 6 and 15;Primary end point(s): Pilot phase of DAWN-ANTICO:<br>D-dimer on day 6<br><br>Clinical status of subject at day 15 (on a 7-point ordinal scale): <br>1. Not hospitalized, no limitations on activities <br>2. Not hospitalized, limitation on activities; <br>3. Hospitalized, not requiring supplemental oxygen; <br>4. Hospitalized, requiring supplemental oxygen; <br>5. Hospitalized, on non-invasive ventilation or high flow oxygen devices; <br>6. Hospitalized, on invasive mechanical ventilation or ECMO; <br>7. Death.<br><br>Primary outcome will be time from Day 0 to sustained clinical improvement or life discharge, whichever comes first, whereby a sustained clinical improvement is defined as an improvement of > 2 points vs the highest value of Day 0 and 1 and sustained for at least 3 days.;Secondary Objective: To evaluate the clinical efficacy of different investigational therapeutics as compared to one another or the control arm as assessed by Clinical Severity, Oxygenation, Mechanical Ventilation, Hospitalisation, Host thrombo-inflammatory status, Mortality and<br>Evaluate the safety of the interventions through 28 days of follow-up as compared to the control arm as assessed by<br>o Cumulative incidence of serious adverse events (SAEs) and adverse events (AEs) graded as severe.<br>o Discontinuation or temporary suspension of drug administration (for any reason). <br>o Changes in white cell count, haemoglobin, platelets, creatinine, glucose, total bilirubin, ALT, and AST over time. | | | | Yes | False | | |
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| EUCTR2020-002394-94-BE | 7 September 2020 | Pulsed, inhaled nitric oxide (iNO) for the treatment of patients with mild or
moderate corona virus disease (COVID-19) | Pulsed, inhaled nitric oxide (iNO) for the treatment of patients with mild or
moderate corona virus disease (COVID-19) | | Dr. De Backer Wilfried BV | 04/06/2020 | 20200604 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002394-94 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 22/06/2020 | 6 | Interventional clinical trial of medicinal product | Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Belgium | Clinical Trial Information Desk | | Lange Lozanastraat 142 (Regus 2nd floor) | wilfried.debacker@outlook.com | 0032476084883 | Dr. De Backer Wilfried BV | Inclusion criteria: <br>1. Signed Informed Consent Form (and assent as appropriate) prior to<br>the initiation of any study mandated procedures or assessments.<br>2. At least 18 years old<br>3. Hospitalized patients with proven or high suspicion of SARS-CoV-2<br>infection and on supplemental oxygen >2 L/minute and = 10 L/minute<br>4. Suspected or proven pneumonia on chest imaging<br>5. Female patients of childbearing potential must have a negative pretreatment<br>pregnancy test (serum or urine). All female patients should<br>take adequate precaution to avoid pregnancy.<br>6. Willing and able to comply with treatment schedule and study<br>procedures.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 3<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 3<br> | Exclusion criteria: <br>1. Participating in any other clinical trial of an experimental treatment<br>for COVID-19<br>2. Gas exchange and ventilation requiring the use of any continuous<br>positive airway pressure (CPAP), or any system of Non Invasive<br>Ventilation (NIV), with Positive End-Expiratory Pressure (PEEP) = 10<br>cmH2O prior to initiation of iNO<br>3. Pregnancy, or positive pregnancy test in a pre-dose examination<br>4. Open tracheostomy<br>5. Clinical contra-indication, as deemed by the attending physician including chronic lung disease<br>6. Use of a nitric oxide donor agent such as nitroglycerin or drugs<br>known to increase methemoglobin such as lidocaine, prilocaine,<br>benzocaine or dapsone at screening<br>7. Known history or clinical evidence of heart failure, left ventricular<br>dysfunction (LVEF < 40 %)<br>8. Patients reporting hemoptysis<br> | Corona virus disease <br>MedDRA version: 23.0
Level: LLT
Classification code 10084355
Term: COVID-19 virus test positive
System Organ Class: 100000004848
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084383
Term: Novel COVID-19-infected pneumonia
System Organ Class: 100000004862
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084401
Term: COVID-19 respiratory infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: iNO<br>Pharmaceutical Form: Pressurised inhalation<br><br> | Timepoint(s) of evaluation of this end point: Assessed at the start of iNOpulse treatment,during treatment, upon completion of treatment and at follow up (Day 28).;Primary end point(s): Clinical evaluation of INOpulse for patients with COVID-19 using clinical<br>1. Death<br>2. Hospitalized, requiring mechanical ventilation or ECMO<br>3. Hospitalized, requiring non-invasive ventilation or high flow oxygen<br>4. Hospitalized, requiring supplemental oxygen<br>5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise)<br>6. Hospitalized, not requiring supplemental oxygen - not requiring ongoing medical care (COVID-19 related or otherwise)<br>7. Not hospitalized - limitation on activities and/or requiring home oxygen<br>8. Not hospitalized, no limitations on activities;Secondary Objective: Not applicable;Main Objective: The objective of this study is to examine the utility of high resolution<br>computed tomography (HRCT) to measure changes in functional<br>pulmonary imaging parameters as a function of iNO administration using<br>the device INOpulse in relation to the corona virus disease. Changes<br>from baseling to at least 5 minutes of iNO and after 5 days using iNO 8 to<br>24 h/day.<br>Clinical evaluation of INOpulse for patients with COVID-19 using clinical<br>and imaging endpoints | | | | Yes | False | | |
| → | EUCTR2020-001673-75-GB | 7 September 2020 | Phase 2/3 study of ABX464, once daily oral capsule, in high risk patients infected by SARS-CoV-2 prior to respiratory distress.
| A phase 2/3, randomized, double blind, placebo-controlled study to evaluate the
efficacy and the safety of ABX464 in treating inflammation and preventing COVID-19
associated acute respiratory failure in patients aged = 65 and patients aged =18 with
at least one additional risk factor who are infected with SARS-CoV-2. (the MiR-AGE
study).
| | ABIVAX | 04/06/2020 | 20200604 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001673-75 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 02/07/2020 | 1034 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| United Kingdom;Italy;Germany;Chile;Peru;Belgium;Brazil;Spain;Mexico;France | Clinical operations | | 5 rue de la baume | Paul.Gineste@abivax.com | | abivax | Inclusion criteria: <br>A patient will be eligible to participate in this study if ALL the following criteria are met:<br>1. Adult (= 18 years old) men or women hospitalized or not hospitalized, diagnosed<br>for SARS-CoV-2 infection by PCR (within 48 hours prior to randomization), with at least one associated risk factor. Considered risk factors are:<br>• Age = 65 years<br>• Obesity defined as BMI = 30<br>• Recent history of uncontrolled High Blood Pressure (SBP > 150 mm Hg & DBP >100 mm Hg) according to investigator<br>• Treated diabetes (type I or II)<br>• History of ischemic cardiovascular disease <br>2. Symptomatic patients must present at least 1 of the following symptoms at enrollment: fever or perceived fever (for more than 24 hours, headache, sore throat, dry cough, fatigue, chest pain or choking sensation (with no associated respiratory distress), myalgia, anosmia, ageusia or gastro-intestinal symptoms.<br>3. Patients with pulse oximetry arterial saturation (SpO2) = 92 % on room air at<br>enrolment.<br>4. Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior to D0:<br>• Hemoglobin > 9.0 g dL-1<br>• Absolute Neutrophil Count = 1000 mm-3;<br>• Platelets = 100,000 mm-3;<br>• Creatinine clearance = 50 mL min-1 by the Cockcroft-Gault formula<br>• Total serum bilirubin < 2 x ULN<br>• Alkaline phosphatase< 2 x ULN, AST (SGOT) and ALT (SGPT) < 3 x ULN;<br>5. Women of childbearing potential and men receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to enrolment. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test. Highly effective methods of contraception include true abstinence, intrauterine device (IUD) or hormonal contraception aiming at inhibition of ovulation, intrauterine hormone releasing system, bilateral tubal ligation, vasectomized partner. True abstinence is defined when this is in line with the preferred and usual lifestyle of the patient. In each case of delayed menstrual period (over one month between menstruation) confirmation of absence of pregnancy is required. This recommendation also applies to WOCBP with infrequent or irregular menstrual cycle. Female and male patients must not be planning pregnancy during the trial and for 6 months post completion of their participation in the trial. In addition, male patients should use condom during the trial and for 6 months (180 days) post completion of their participation in the study. Male patients must not donate sperm as long as contraception is required. For the purpose of this protocol, a woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a<br>post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However, in the absence of 12 months of amenorrhea, a single FSH measurement is insuff | Exclusion criteria: <br>Patients who meet any of the following exclusion criteria will be excluded from the study:<br>1. Patients with moderate or severe acute respiratory failure or requiring non-invasive ventilation or oxygen or with SpO2 < 92% or tachypnea (respiratory rate = 30 breaths/min).<br>2. Patients treated with immunosuppressors and/or immunomodulators (cf. Appendix #2).<br>3. Engrafted patients (organ and/or hematopoietic stem cells).<br>4. Patients with uncontrolled auto-immune disease.<br>5. Patients with known or suspected active (i.e. not controlled) bacterial, viral<br>(excluding COVID-19) or fungal infections.<br>6. Patients with preexisting, severe and not controlled organ failure.<br>7. History or active malignancy requiring chemotherapy or radiation therapy (excluding 2 years disease free survivor patients).<br>8. Pregnant or breast-feeding women.<br>9. Illicit drug or alcohol abuse or dependence that may compromise the patient's safety or adherence to the study protocol.<br>10. Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer.<br>11. Hypersensitivity to ABX464 and/or its excipients.<br>12. Any condition, which in the opinion of the investigator, could compromise the patient's safety or adherence to the study protocol.<br><br> | Infection with SARS-CoV-2 virus, COVID-19 infection;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Code: ABX464<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: ABX464<br>Current Sponsor code: ABX464<br>Other descriptive name: ABX464<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 50-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: Day 28;Primary end point(s): Rate of patients with no invasive or non-invasive mechanical ventilation (IMV and NIV, respectively), but excluding simple nasal/mask oxygen supplementation, and who are alive at the end of the 28 days period.;Secondary Objective: Evaluate the proportion of patients requiring hospitalization compared to the {Standard of care + placebo} group<br>Assess the proportion of patients reporting each severity rating on a 7-point ordinal scale <br>Assess the time to an improvement of one category of the a 7-point on an ordinal scale from baseline<br>To evaluate and compare the effect of ABX464 on oxygen saturation before hospitalization<br>To evaluate and compare the effect of ABX464 on oxygen saturation level at the end of the study treatment<br>Evaluate and compare the effect of ABX464 on immunophenotyping and cytokines levels <br>Evaluate the proportion of patient requiring oxygen supplementation <br>Assess the time to hospitalization <br>Evaluate the time to application of invasive and non-invasive mechanical ventilation or high flow oxygen therapy <br>Assess the IMV and/or NIV duration <br><br>Please refer to the study protocol for further objections<br><br><br><br>;Main Objective: The primary objective of the study is to determine the efficacy of ABX464 50mg to prevent respiratory failure or death in study patients.→Main Objective: The primary objective of the study is to determine the efficacy of ABX464 50mg to prevent respiratory failure or death in study patients.;Secondary Objective: Evaluate the proportion of patients requiring hospitalization compared to the {Standard of care + placebo} group<br>Assess the proportion of patients reporting each severity rating on a 7-point ordinal scale <br>Assess the time to an improvement of one category of the a 7-point on an ordinal scale from baseline<br>To evaluate and compare the effect of ABX464 on oxygen saturation before hospitalization<br>To evaluate and compare the effect of ABX464 on oxygen saturation level at the end of the study treatment<br>Evaluate and compare the effect of ABX464 on immunophenotyping and cytokines levels <br>Evaluate the proportion of patient requiring oxygen supplementation <br>Assess the time to hospitalization <br>Evaluate the time to application of invasive and non-invasive mechanical ventilation or high flow oxygen therapy <br>Assess the IMV and/or NIV duration <br><br>Please refer to the study protocol for further objections<br><br><br><br>;Primary end point(s): Rate of patients with no invasive or non-invasive mechanical ventilation (IMV and NIV, respectively), but excluding simple nasal/mask oxygen supplementation, and who are alive at the end of the 28 days period.;Timepoint(s) of evaluation of this end point: Day 28 | | | | Yes | True | child | |
| KCT0005370 | 7 September 2020 | Production of SARS-CoV-2 antigen specific immune cell therapy | Production of SARS-CoV-2 antigen specific cytotoxic T lymphocytes | | The Catholic University of Korea, Seoul St. Mary's Hospital | 2020-09-02 | 20200902 | CRIS | http://cris.nih.go.kr/cris/en/search/search_result_st01.jsp?seq=17259 | Recruiting | No | 20(Year) | 65(Year) | Both | 2020-07-21 | 10 | Interventional Study | Primary Purpose : Other(Human resource study- Cell therapy study (Blood collection)), Intervention Model : Other(Human resource study- Cell therapy study (Blood collection)), Blinding/Masking : Open, Allocation : Not Applicable | Not applicable | Korea, Republic of | Jong Min | Lee | | | | The Catholic University of Korea, Seoul St. Mary's Hospital | Inclusion criteria: For COVID-19 treated individuals:<br>1. Those who consent to the study<br>2. Aged 20 - to 65 years old<br>3. Individual who has been diagnosed with COVID-19 and released from quarantine, that is, the person who meets all the criteria for public release by the CDC:<br>A. (clinical standard): no fever and no clinical symptoms<br>B. (diagnostic criteria) PCR test results are negative twice every 24 hours<br><br>For health donors: <br>1. Those who consent<br>2. Aged 20 to 65 years old<br>3. Those who do not have any fever or respiratory symptoms<br>4. Negative for Anti-SARS-CoV-2 Ab IgG antibodies | Exclusion criteria: 1. Those who do not consent<br>2. Those under 20 or over 65 years of age<br>3. Positive for Anti-SARS-CoV-2 IgG antibodies<br>4. Positive for HIV, syphilis or hepatitis B and C carriers.<br>5. Those with any active infections requiring systemic medical treatment<br>6. Those who have been diagnosed with any other serious diseases | ;Certain infectious and parasitic diseases | Biological/Vaccine, Non-Stem Cell : Blood collection of 50cc, once<br>Periphieral blood mononuclear cells are isolated and the cells are expanded in culture using cytokines for 21 days to generate antigen specific immune cells. | Fold expansion following culture of SARS-CoV-2 virus antigen peptide mixture treated peripheral nucleated cells;Cell number following culture of SARS-CoV-2 virus antigen peptide mixture treated peripheral nucleated cells | 02/09/2020 | 31/03/2021 | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| IRCT20200718048129N1 | 7 September 2020 | Evaluation of the effectiveness of Hydroxychloroquine and Clarithromycin in dyspnea and caugh caused by COVID-19 in recovery phase | Evaluation and comparison of the effectiveness of Hydroxychloroquin versus Clarithromycin in recovery of dyspnea and Caugh at the end of the acute phase of COVID-19 treatment | | Iran University of Medical Sciences | 2020-08-11 | 20200811 | IRCT | http://en.irct.ir/trial/49729 | Recruiting | No | 20 years | 50 years | Both | 2020-08-22 | 45 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In our study, the simple randomization method is used as follows. A number of sealed envelopes in which study groups with letters A, intervention group with hydroxychloroquine, group B, intervention with clarithromycin and group C, including the control group, have been identified.The number of envelopes in each group is equal in number. The cards are merged and a card is randomly selected for each referring patient, thus assigning the patient to one of the groups. The removed card is then returned to the other cards. This process continues until a random sequence is reached according to the sample size in each group. | 3 | Iran (Islamic Republic of) | Sima Bahrami | | Hazrate Rasoole Akram hospital,Niayesh St,Satarkhan Av,Tehran | bahrami.s@iums.ac.ir | +98 21 6435 1000 | Iran University of Medical Sciences | Inclusion criteria: Patients with definitive diagnosis of COVID19 were hospitalized and treated<br>Patients with COVID19 who still have dyspena and cough two weeks after discharge from the hospital<br>Patients with COVID19 who continue to have lung involvement on CT SCAN two weeks after discharge | Exclusion criteria: Patients with comorbidities such as chronic heart or lung disease before COVID19<br>The need for long-term use of drugs that have an irreversible interaction with the drugs used in the plan. | COVID-19. <br>COVID19 ,virus identified;U07.1 | Intervention 1: Intervention group 1: Hydroxychloroquine tablets 200 mg every 12 hours for one month fram Rooz daroo company. Intervention 2: Intervention group 2: Clarithromycin 500 mg capsules every 12 hours for one month from Tehran shimi company. Intervention 3: Control group: without receiving medication during a one-month follow-up. | Cough. Timepoint: Beginning of the study (before the intervention), 14, 30 days after the start of the study. Method of measurement: visual analogue scale(vas).;Dyspnea. Timepoint: Beginning of the study (before the intervention), 14, 30 days after the start of the study. Method of measurement: Medical Research Council(MRC). | | | | Yes | False | | |
| → | IRCT20200725048199N1 | 7 September 2020 | Evaluation of the effect of Shalomin on the treatment and improvement of symptoms in patients with Covid 19 | Investigating the effect of oral and spray shalomine on the treatment and improvement of symptoms in patients with COVID19 | | Dezfoul University of Medical Sciences | 2020-08-11 | 20200811 | IRCT | http://en.irct.ir/trial/49853 | Recruiting | No | no limit | no limit | Both | 2020-08-10 | 146 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Initially, random sampling is simple and uses a random number table. Samples are selected over a two-week period. In the next step, using block randomization, patients are divided into two groups of 73 intervention patients (oral shalomin and its respiratory spray) and a 73-member control group (without additional intervention). The basis of block random division is based on a quadruple chain of combinations A (intervention group) and B (control group), Blinding description: In terms of blinding, this study is performed as a double-blind. In the control group, syrups and sprays containing distilled water are used to blind patients. Based on the labeling of the main drug and placebo, the researcher will also be unaware of the use of intervention in groups. Proper blinding is done in two directions (Double Blinding). | 3 | Iran (Islamic Republic of) | mahnaz nosratabadi | | Azadegan Boulevard | nosratabadi.m@Dums.ac.ir | +98 61 4242 3308 | Dezfoul University of Medical Sciences | Inclusion criteria: Positive coronavirus test<br>willingness to participate in the study<br>not receiving any medication other than the common COVID19 treatment protocol<br>people who need to be hospitalized based on blood oxygen saturation and respiratory status. | Exclusion criteria: Infection with other microbial or viral infections<br>severe form of COVID19 disease<br>inability to use syrup and respiratory spray Shalomin | Coronavirus disease (COVID-19). <br>COVID-19, virus identified;U07.1 | Intervention 1: The intervention group, in addition to receiving the approved treatment protocol for COVID19, uses Shalomin oral syrup (prepared from shallot extract) 10 cc every 6 hours and Shalomin spray 1 puff every 6 hours in each nostril and 2 puffs in the throat. To prepare the antiviral fraction, which is one of the flavonoids in the active plant ingredients, first aqueous extract is prepared from shallot plant, then column chromatography is used to separate the active ingredient from the extract and the active ingredient is separated and purified. It is then used as a syrup and spray for formulation. The formulation of the drug is a syrup containing 0.1% shalomine and 10% glycerin in double distilled water and a spray containing 0.1% shalomine and 10% ethanol in double distilled water, which will be prepared in Sadra Noor Biotechnology Pharmaceutical Company. (This drug has been patented by Dr. Mansour Amin for the treatment of herpes simplex virus type 1). Intervention 2: Control group: The control group will receive the approved treatment protocol for COVID19 without additional intervention. | Corona virus test result. Timepoint: Two weeks after starting treatment. Method of measurement: Based on the results of corona virus polymerase chain reaction test.;Alteration of clinical and paraclinical symptoms of Covid 19 in patients. Timepoint: Once every three days after starting treatment until finally one month after starting treatment. Method of measurement: Based on vital signs and paraclinical information.→Alteration of clinical and paraclinical symptoms of Covid 19 in patients. Timepoint: Once every three days after starting treatment until finally one month after starting treatment. Method of measurement: Based on vital signs and paraclinical information.;Corona virus test result. Timepoint: Two weeks after starting treatment. Method of measurement: Based on the results of corona virus polymerase chain reaction test. | | | | No | False | | |
| IRCT20160808029264N9 | 7 September 2020 | Effects of chest physiotherapy in COVID-19 patients with respiratory infection | The effects of chest physiotherapy on respiratory capacity and the rate of respiratory gas exchange during walking on the treadmill in patients with COVID-19 after the recovery stage | | Semnan University of Medical Sciences | 2020-08-15 | 20200815 | IRCT | http://en.irct.ir/trial/49890 | Not Recruiting | No | 35 years | 55 years | Both | 2020-09-20 | 44 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, a simple randomization method in the form of a random number table will be used. Patients with odd numbers will be assigned in the intervention group and patients with even numbers will be assigned in the control group, Blinding description: This study is a double-blind randomized clinical trial. In this way, patients are divided into two groups by one researcher who does not interfere in the intervention and evaluation of results, and in addition, the evaluation will be performed by another researcher who is not aware of grouping. | 2-3 | Iran (Islamic Republic of) | Dr Rasool Bagheri | | Ghods Ave., Neuromuscular Rehabilitation Research Center | rasool.bagheri@ymail.com | +98 23 3365 4180 | Semnan University of Medical Sciences | Inclusion criteria: People with a history of hospitalization in the Hospital of Semnan University of Medical Sciences due to the COVID-19 virus.<br>A minimum of 1 month and a maximum of 2 months from the time of discharge from the hospital<br>Positive PCR test or diagnosis of lung involvement based on CT scan of the lung at the time of admission<br>No drug and smoking addiction<br>No previous history of chronic lung disease<br>Lack of musculoskeletal diseases such as tumor fractures and ... | Exclusion criteria: Any aggravation of the patient's symptoms due to shortness of breath and pain in the chest and dizziness, abnormal sweating, blurred vision and nausea ...<br>Any cases that are prohibited for performing chest physiotherapy intervention in people with this disease. | Respiratory infection due to COVID-19. <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: Chest physiotherapy intervention 5 days in a week for 10 sessions: 1- Segmental breathing exercises for lung lobes in lying and sitting position 2- Proper posture (postural drainage) 3- Deep breathing and diaphragmatic exercises 4- Incentive spirometer 5- Controlled movement and movement and breathing exercises while riding a stationary bike. Intervention 2: Control group: Standard treatments include medications prescribed for the disease as directed by the treating physician. In the control group, after the study phase, 10 sessions of physiotherapy will be performed as mentioned in the intervention group. | Tidal volume, residual volume and other lung volumes while resting and running on a treadmill. Timepoint: Before and after the physiotherapy intervention. Method of measurement: Spirometry device. | | | | Yes | False | | |
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| IRCT20101219005416N3 | 7 September 2020 | Effect of traditional medicine protocol included Astraglus gossypinus with Ferula assa capsule on improvement of COVID-19 outpatients symptoms | Evaluation of the effect of traditional medicine protocol included Astraglus gossypinus with Ferula assa capsule on improvement of COVID-19 outpatients symptoms treated with conventional protocol | | Kerman University of Medical Sciences | 2020-08-26 | 20200826 | IRCT | http://en.irct.ir/trial/50101 | Recruiting | No | 18 years | 80 years | Both | 2020-08-10 | 120 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is done by permutation randomized block method in four-sided blocks. The construction of blocks is done with R version software 2, 3,. | N/A | Iran (Islamic Republic of) | Haleh Tajadini | | No9, 19 Jahad Blvd, Kerman | drhalehtajadini@gmail.com | +98 34 3243 5539 | Kerman University of Medical Sciences | Inclusion criteria: The patients that confirmed COVID- 19 with specialist on the base of CT changing or pharyngeal specimen or clinical symptoms | Exclusion criteria: Lack of informed consent, Pregnancy, Breastfeeding | covid-19. <br>Confirmed COVID-19;U07.1 | Intervention 1: Control group: Hospitalized patients are receiving standard corona treatment. Intervention 2: Intervention group: Patients admitted to hospital in addition to receiving standard treatments of the Corona Country Committee, received a traditional product based on Astragalus gossypinus of 10 cc daily for 3 hours and two Ferula assa-foetida capsule of 500mgr daily. Traditional protocol duration is 5 days. | Response to the treatment (Significant clinical improvement). Timepoint: At baseline and daily. Method of measurement: Based on clinical, paraclinical and laboratory findings. Clinical improvement: normalization of the body temperature (=37.2 ° C), respiratory rate (=24 breaths per minute), cough; dyspnea; headche and dirrhea that will measure on a qualitative scale based on the patient's report. Other outcome variables will measure during clinical examination. | | | | No | False | | |
| → | IRCT20200806048318N1 | 7 September 2020 | The effect of herbal tea on improving respiratory symptoms in patients with Covid-19 | The effect of herbal tea (including mallow flower, chicory seeds, sweet violet flower, Melilotus officinalis and Bindii) on improving respiratory symptoms in patients with Covid-19 | | Esfahan University of Medical Sciences | 2020-08-20 | 20200820 | IRCT | http://en.irct.ir/trial/50227 | Not Recruiting | No | 15 years | 60 years | Both | 2020-09-22 | 80 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be divided into two groups of 40 using the random block method with 2 blocks. So that the first two cases are separated and assigned to group one, the second two cases are separated and assigned to group two, and this will be continued two by two in the same way till the ending of samples. | 3 | Iran (Islamic Republic of) | Mehdi Akhveh | | Unit 7, First Floor, No. 26, Residence Apartment, Sub-12, West Alley, Telecommunication Street, Shahinshahr. | arnica.darou@gmail.com | +98 31 3312755 | Esfahan University of Medical Sciences | Inclusion criteria: Positive result of PCR or CT SCAN of COVID-19 disease in accordance with international standards<br>Age 60-15 years<br>Patient consent to participate in the study | Exclusion criteria: Has diseases such as Alzheimer's, Parkinson's, multiple sclerosis, neuromuscular diseases, myasthenia gravis<br>Pregnant women<br>Patients with blood pressure lower than 40/90 mmHg<br>Breathe more or equal to 30 per minute<br>Blood oxygen saturation less than 93% at rest<br>PaO2 to FiO2 ratio less than or equal to 300 mmHg<br>Patients with more than 50% of exudative lesions in 24-48 hours in the lung image | COVID-19 disease. <br>COVID-19 disease;U07.1 | Intervention 1: Intervention group: Patients in this group, in addition to receiving routine treatment, will use the herbal tea including mallow flower, chicory seeds, sweet violet flower, Melilotus Officinalis, and Bindii. In this way, a jam spoon (equivalent to 5 grams of powdered this herbal composition) with a cup of boiling water (equivalent to 150 cc) is brewed for 25-30 minutes and after straining it is given to the patient. This herbal tea will be prescribed half an hour after lunch for 5 days. Intervention 2: Control group: Patients in this group will be received only routine treatment. | Respiratory rate. Timepoint: Before the intervention and the first to fifth days of treatment. Method of measurement: Observation.;Number of coughs. Timepoint: Before the intervention and the first to fifth days of treatment. Method of measurement: Observation.;Percentage of oxygen saturation. Timepoint: Before the intervention and the first to fifth days of treatment. Method of measurement: Pulse Oximeter device.;Shortness of breath. Timepoint: Before the intervention and the first to fifth days of treatment. Method of measurement: Observation.→Shortness of breath. Timepoint: Before the intervention and the first to fifth days of treatment. Method of measurement: Observation.;Percentage of oxygen saturation. Timepoint: Before the intervention and the first to fifth days of treatment. Method of measurement: Pulse Oximeter device.;Number of coughs. Timepoint: Before the intervention and the first to fifth days of treatment. Method of measurement: Observation.;Respiratory rate. Timepoint: Before the intervention and the first to fifth days of treatment. Method of measurement: Observation. | | | | Yes | False | | |
| IRCT20200506047323N5 | 7 September 2020 | Melatonin in COVID-19 | Evaluation of the efficacy and safety of Melatonin in patients with COVID-19: a randomized clinical trial | | Bandare-abbas University of Medical Sciences | 2020-08-14 | 20200814 | IRCT | http://en.irct.ir/trial/50239 | Recruiting | No | 20 years | no limit | Both | 2020-08-22 | 60 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be performed (each block consists 6 patients). Allocation sequence and concealment codes will be generated using www.sealedenvelope.com. The closed envelope method will be used to hide the allocation sequence, Blinding description: The medication and placebo will be coded by the project manager. Patients will be randomly allocated within the blocks based on the hidden codes, and study participants, physicians, and nurses who evaluate the outcomes will be blind to the intervention and studied groups. | 3 | Iran (Islamic Republic of) | Mohammad Fathalipour | | Emam Hossein Blvd | m.fathalipour@hums.ac.ir | +98 76 3371 0406 | Bandare-abbas University of Medical Sciences | Inclusion criteria: Age >20 years<br>Positive polymerase chain reaction (PCR) test for COVID-19 or/and lung involvement in imaging<br>Primary clinical symptoms<br>Hospitalized and moderate patients<br>Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm | Exclusion criteria: Patients with underlying diseases including hypertension, diabetes, seizure, depression, chronic hepatitis, cirrhosis, and cholestatic liver diseases<br>Use of anticoagulant drugs like warfarin, hormonal drugs, alcohol, and any illegal drugs (during last 30 days)<br>History of allergy to Melatonin<br>Pregnancy and breastfeeding | COVID-19 disease. <br>COVID-19, virus not identified;U07.2 | Intervention 1: Intervention group: The standard treatment for COVID-19 based on the Ministry of Health's protocol including hydroxychloroquine sulfate (Amin Pharmaceutical company, Isfahan) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for six following days, along with melatonin capsules (Vana Darou Gostar Pharmaceutical Company, Iran) at a dose of 50 mg once a day for a period of seven days. Intervention 2: Control group: Hydroxychloroquine sulfate (Amin Pharmaceutical company, Isfahan) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for six following days, along with melatonin-like placebo capsules (Vana Darou Gostar Pharmaceutical Company, Iran) at a dose of one capsule daily for a period of seven days. | Body temperature. Timepoint: Before intervention and daily during the study. Method of measurement: Thermometer.;Respiratory rate. Timepoint: Before intervention and daily during the study. Method of measurement: Respiratory Count.;Oxygen saturation. Timepoint: Before intervention and daily during the study. Method of measurement: Pulse oximeter. | | | | Yes | False | | |
| IRCT20090701002113N2 | 7 September 2020 | Methylene Blue in COVID-19 | Methylene Blue for the Treatment of COVID-19: A Randomized Clinical Trial | | Shiraz University of Medical Sciences | 2020-08-25 | 20200825 | IRCT | http://en.irct.ir/trial/50275 | Recruiting | No | 18 years | no limit | Both | 2020-08-15 | 260 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random allocation (case:control 1:1) will be done using the permuted block randomization method (block size of 4). The randomization sequence will be generated with an online program available from https://www.sealedenvelope.com/simple-randomiser/v1/lists. The generated random sequence will be inserted in an opaque envelop enumerated in sequence from 001 to 260, each of which will be used for consecutive study participants. | 3 | Iran (Islamic Republic of) | Jamshid Roozbeh | | Shahid Faghihi Hospital | roozbehj@sums.ac.ir | +98 71 1235 6400 | Shiraz University of Medical Sciences | Inclusion criteria: >18 yrs old<br>PCR confirmation of COVID-19<br>Severe or critical diseases as: respiratory rate>30 breaths/second, oxygen saturation<94% on room air sea level, lung infiltration of >50%, partial pressure of oxygen/Fraction of inspired oxygen <300 mmHg and/or any individual with respiratory failure, septic shock, and/or multiple organ dysfunction | Exclusion criteria: Pregnancy<br>G6PD deficiency<br>Severe renal failure (defined as glomerular filtration rate<15 mL/min/1.3m2)<br>History of allergic reaction to drug<br>Patients on serotonergic psychiatric drugs (including selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake Inhibitors, tricyclic antidepressants, monoamine oxidase inhibitors), dapsone and different hydroxylamine<br>Organ transplantation recipients<br>Not consenting to enter study | COVID-19 infection. <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: In order to minimize any bias between groups as a general policy, all patients will only receive lopinavir/retonavir (Kaletra®) and corticosteroids as their treatment regimen for COVID-19. Antibiotic medications use will be limited as much as possible and will only be used in each specific case based on the diagnosis of the infectious specialist or intensivist when necessary. On the second day of hospital admission, the intervention group will initially receive a single intravenous bolus of 1 mg/kg (1% solution) of methylene blue administered over 20-60 minutes. The patients will then be given 0.25 mg/kg per hour dose of methylene bluefor 24 hours. Methylene blue has a commercial name of METIBLO and generic name of Methylthioninium chloride . Each 1ml ampule contains 10 mg methylthionium chloride. It is made in Belgium by Oterop company. Intervention 2: Control group: These patients will only receive lopinavir/retonavir (Kaletra®) and corticosteroids as their treatment regimen for COVID-19. Antibiotic medications use will be limited as much as possible and will only be used in each specific case based on the diagnosis of the infectious disease specialist or emergency medicine specialist when necessary. | Death. Timepoint: 2 weeks after intervention. Method of measurement: follow-up visit. | | | | No | False | | |
| → | IRCT20180922041089N4 | 7 September 2020 | Evaluation of the effect of oral Ivermectin on patients with COVID-19 | Evaluation of the effect of oral Ivermectin on the outcome of patients with COVID-19 and compare it with the effect of conucntional therapics in patients admitted to Ziaeian, Baharloo, Imam Khomeini in the spring and summer 2020 | | Tehran University of Medical Sciences | 2020-08-23 | 20200823 | IRCT | http://en.irct.ir/trial/50305 | Not Recruiting | No | 18 years | 50 years | Both | 2020-04-19 | 130 | interventional | Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is a multi-central blind one-way clinical trial. A total of 130 patients aged 18 to 50 years admitted to Ziaeian, Baharloo and Imam Khomeini Educational and Medical Centers have been shown to have Covid 19 with mild to moderate clinical manifestations. According to NEWS (mild score 1-4, average score 5-6), after obtaining written consent consciously, they are randomly divided into two groups. The person in charge of collecting patient information during admission and after evaluating drug treatments is unaware of which of the intervention or control groups the patient is in.The control group consisted of 65 patients who were treated with Hydroxychloroquine and azithromycin and the intervention group consisted of 65 patients who, in addition to the above-mentioned regimen, Ivermectin was added to the treatment protocol.This study is par | 3 | Iran (Islamic Republic of);Iran (Islamic Republic of);Iran (Islamic Republic of) | Abolfazl Zendehdel | | Abuzar Street, Abuzar Square, opposite the 17th district of Ziaeean Hospital | azendedel@sina.tums.ac.ir | +98 21 5517 6031 | Tehran University of Medical Sciences | Inclusion criteria: Patients 18 to 50 years<br>Infected by the COVID 19 virus<br>Patients with clinical symptoms, history of exposure to the patient and a positive RT-PCR test for Covid 19 from A laboratory or characteristic signs on a CT scan of the chest) with mild to moderate clinical manifestations according to the National Early Warning Score (NEWS) (mild: 1-4 / moderate: 5-6)<br>Obtaining informed written consent consciously | Exclusion criteria: Severely ill and hospitalized in the intensive care unit<br>Patients who are unable to take oral medications<br>Patients with AST / ALT levels more than 5 times above normal<br>Pregnant patients | Corona virus. <br>COVID-19, virus identified;U07.1 | Intervention 1: Control group: Patients in the control group are treated with Hydroxychloroquine sulfate and Azithromycin (if there is no cardiac contraindication) according to the protocol of the Ministry of Health. Intervention 2: Intervention group: In the intervention group, in addition to medication Hydroxychloroquine sulfate and Azithromycin,Ivermectin 200 mg (four 3mg tablets in a 60 kg person) is given to the intervention group on the first day and a 3mg tablet is administered every 12 hours for 3 days from the second day.At the beginning of hospitalization NEWS of patients are checked and ECG is performed, and CBC diff test for lymphopenia, LFT, etc. (according to the ministry protocol) is also performed. Patients are compared after hospitalization for NEWS, clinical signs, and lymphocyte counts daily and CT scan is performed on the last day of hospitalization. | Improving paraclinical indicators of the disease. Timepoint: Daily lymphocyte count - the last day of hospital CT scan. Method of measurement: Lymphocyte count - CT scan.;Reducing the length of hospitalization. Timepoint: Daily. Method of measurement: Counting.;Improving clinical symptoms. Timepoint: Daily. Method of measurement: National Early Warning Score? (NEWS).→Improving clinical symptoms. Timepoint: Daily. Method of measurement: National Early Warning Score? (NEWS).;Reducing the length of hospitalization. Timepoint: Daily. Method of measurement: Counting.;Improving paraclinical indicators of the disease. Timepoint: Daily lymphocyte count - the last day of hospital CT scan. Method of measurement: Lymphocyte count - CT scan. | | | | No | False | | |
| IRCT20161108030776N3 | 7 September 2020 | Effect of donkey milk on the new corona virus infection | Evaluation of the effect of dairy product donkey milk on the course of signs of patients with suspected corona disease (COVID-19) | | Kerman University of Medical Sciences | 2020-08-26 | 20200826 | IRCT | http://en.irct.ir/trial/50341 | Recruiting | No | 18 years | 65 years | Both | 2020-09-05 | 110 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, according to the inclusion criteria, patients are selected and then according to the random sequence obtained through random allocation software, in the same random order, patients will be divided into two groups of test and control. | N/A | Iran (Islamic Republic of) | Haleh Tajadini | | Faculty of Persian Medicine, Amirkabir Intersection, Jomhuri Eslami Boulevard | dr_haleh@yahoo.com | +98 34 3211 0860 | Kerman University of Medical Sciences | Inclusion criteria: Patients with COVID-19<br>Mild to moderate disease<br>Candidates for outpatient treatment based on the protocol of the Ministry of Health<br>Patients 18-65 years old | Exclusion criteria: Patients with allergies and asthma<br>Patients with hypertension<br>Patients with diabetes<br>Pregnancy / lactation<br>Patients with heart failure<br>Patients with chronic renal failure<br>Patients undergoing chemotherapy<br>Patients receiving corticosteroids<br>Patients with immunodeficiency | COVID-19. <br>COVID-19;U07.1 | Intervention 1: Intervention group: In addition to drug treatment according to the protocol of the Ministry of Health, patients in this group receive donkey milk at a rate of 300 cc daily with 5 grams of candy for 5 days. Intervention 2: Control group: Patients in this group receive medication according to the protocol of the Ministry of Health. | Diarrhea (watery stools). Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Question from the patient.;Breathing speed. Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Count the number of breaths per minute.;Body pain. Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Visual analog scale (VAS).;Weakness and lethargy. Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Visual analog scale (VAS).;Cough (severity-frequency). Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Fiston Scale.;Body temperature. Timepoint: Days 0-1-2-3-4-7-14 after the start of the intervention. Method of measurement: Mercury thermometer. | | | | Yes | False | | |
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| EUCTR2020-001860-27-GB | 21 September 2020 | AGILE: Seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 treatment. A randomised Phase I/II study to determine the safety and effectiveness of multiple drugs for the treatment of COVID-19 | AGILE: Seamless Phase I/IIa Platform for the Rapid Evaluation of Candidates for COVID-19 treatment - AGILE | | University of Liverpool | 17/04/2020 | 20200417 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001860-27 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 12/05/2020 | 250 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: yes<br>Other specify the comparator: Standard of care or Placebo<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United Kingdom | Ellice Marwood | | MP131, Southampton General Hospital, Tremona Road | e.marwood@soton.ac.uk | 023 8120 5608 | Southampton Clinical Trials Unit | Inclusion criteria: <br>Master Protocol:<br><br>Patients are eligible to be included in the study only if all of the following criteria apply (as well as all criteria from the appropriate candidate-specific trial protocol): <br>1. Adults (=18 years) with laboratory-confirmed* SARS-CoV-2 infection (PCR)<br>2. Ability to provide informed consent signed by study patient or legally acceptable representative<br>3. Women of childbearing potential (WOCBP) and male patients who are sexually active with WOCBP must agree to use a highly effective method of contraception from the first administration of trial treatment, throughout trial treatment and for the duration outlined in the candidate-specific trial protocol after the last dose of trial treatment<br>*If any CSTs are included in the community setting, the CST protocol will clarify whether patients with suspected SARS-CoV-2 infection are also eligible. <br><br>Standard additional criteria that may be applied per candidate-specific trial protocol:<br><br>Group A (severe disease)<br>Patients with clinical status of Grades 5 (hospitalised, oxygen by mask or nasal prongs), 6 (hospitalised, non-invasive ventilation or high flow oxygen), 7 (hospitalised, intubation and mechanical ventilation, pO2/FiO2 =150 or SpO2/FiO2 =200), 8 (hospitalised mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors or 9 (hospitalised, mechanical ventilation pO2/FiO2 <150 and vasopressors, dialysis or ECMO) (as defined by the WHO Clinical Progression Scale.<br><br>Group B (mild-moderate disease)<br>4b. Ambulant or hospitalised patients with peripheral capillary oxygen saturation (SpO2) >94% RA.<br><br>Nomacopan Candidate-Specific Trial:<br>Additional inclusion criteria specific to this CST are:<br><br>1. Adults (=18 years) with laboratory-confirmed SARS-CoV-2 infection (PCR) who are within 5 days of symptom onset. <br>4. A score of grade 4, 5, 6 or 7 on the 9-Point Ordinal Scale* <br>Grade 6 and 7 will only be accepted when second cohort open to recruitment. <br><br>CST-2 (EIDD-2801) additional inclusion criteria:<br>5. Has signs or symptoms of COVID-19 that began within 5 days of the planned first dose of study drug.<br>6. Is in generally good health (except for current respiratory infection) and is free of uncontrolled chronic conditions.<br>7. Is willing and able to comply with all study procedures and attending weekly clinic visits through the 4th week.<br>8. Has someone, aged = 16 living in the same household during the dosing period.<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 200<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 50<br> | Exclusion criteria: <br>Master Protocol: <br>Patients are excluded from the study if any of the following criteria apply (as well as all criteria from the appropriate candidate-specific trial protocol): <br>1. Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN) <br>2.Stage 4 severe chronic kidney disease or requiring dialysis (i.e., estimated glomerular filtration rate <30 mL/min/1.73 m2)<br>3.Pregnant or breast feeding <br>4. Anticipated transfer to another hospital which is not a study site within 72 hours <br>5. Allergy to any study medication <br>6. Patients taking other prohibited drugs (as outline in CST protocol) within 30 days or 5 times the half-life (whichever is longer) of enrolment <br>7. Patients participating in another CTIMP trial <br><br>Nomacopan Candidate-Specific Trial:<br>For the purpose of the nomacopan candidate-specific trial, appendix exclusion criteria 6 has been amended from the Master protocol as follows, to restrict the population of patients that will be included in the trial:<br>6. Patients taking the following prohibited drugs:<br>• Other complement inhibiting drug such as eculizumab (Soliris®).<br>• Any other drug which directly inhibits cytokines, chemokines or proinflammatory mediators such as tocilizumab (Actemra®/RoActremra®), anakinra (Kineret®), etanercept (Enbrel®), infliximab (Remicade®) or adalimumab (Humira®).<br>N.B. Whilst it is not thought that there is likely to be any adverse interaction between nomacopan and any of these drugs, in the context of a clinical trial, it would be impossible to distinguish the effects of those agents from that of nomacopan. Corticosteroids, antivirals and antibiotics are permitted in conjunction with nomacopan therapy.<br>Additional exclusion criteria specific to this candidate specific appendix are:<br>8. Weight less than 50kg or more than 100kg<br><br>CST-2 (EIDD-2801) additional exclusion criteria:<br>8. Has a febrile respiratory illness that includes pneumonia that results in hospitalisation, or requires hospitalisation, oxygenation, mechanical ventilation, or other supportive modalities.<br>9. Has a platelet count less than 50x10^9/L.<br>10. Is experiencing adverse events or laboratory abnormalities that are Grade 3 or above based on the CTCAE v5 grading.<br>11. Has clinically significant liver dysfunction or renal impairment.<br>12. Has history of Hepatitis C infection or concurrent bacterial pneumonia.<br>13. Has received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 30 days prior to the first dose of study drug.<br>14. In the opinion of the investigator, has significant end-organ disease as a result of relevant comorbidities: chronic kidney disease, congestive heart failure, peripheral vascular disease including diabetic ulcers.<br>15. Has a SaO2<95% by oximetry or has lung disease that requires supplemental oxygen or maintenance steroids.<br>16. Has any condition that would, in the opinion of the investigator, put the patient at increased risk for participation in a clinical study.<br><br> | Coronavirus-induced disease (COVID-19) (SARS coronavirus 2, or SARS-CoV-2) <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Nomacopan<br>Product Code: rVA576<br>Pharmaceutical Form: Powder for solution for injection<br>INN or Proposed INN: Nomacopan <br>Other descriptive name: VA576<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 18-<br><br>Product Name: EIDD-2801 (MK4482)<br>Pharmaceutical Form: Capsule<br>INN or Proposed INN: EIDD-2801<br>CAS Number: 2349386-89-4<br>Other descriptive name: [(2R,3S,4R,5R)-3,4-dihydroxy-5-[4-(hydroxyamino)-2-oxopyrimidin-1-yl]oxolan-2- yl]methyl 2-methylpro<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 25-200<br>Pharmaceutical form of the placebo: Capsule<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: Master:<br>PI:<br>Treatment will be evaluated for safety and tolerability at day 7 post randomisation using a state-of-the-art Bayesian dose-escalation model.<br>• Group A (severe disease) <br>Time to clinical improvement measured up to 29 days from randomisation.<br>• Group B (mild-moderate disease) <br>Pharmacodynamics of drug defined as time to negative viral titres in nose and/or throat swab, measured up to 29 days from randomisation.<br><br>Nomacopan Candidate-Specific Trial:<br>Safety will be assessed during the treatment period, up to 14 days from first treatment. Assessment of efficacy will be based on the hazard ratio for time to clinical improvement, measured up to day 9.<br><br>CST-2 (EIDD-2801):<br>Phase I: over 7 days (from first dose)<br>Phase II: Up to day 29 (from randomisation) ;Primary end point(s): Master Protocol Co-primary endpoints:<br><br>For dose finding (phase I)<br>• Dose limiting toxicities (Safety and Tolerability of drug under study – CTCAE v5 Grade =3 adverse events)<br><br>For efficacy evaluation (phase II) one of the following depending on the population the candidate is being evaluated in:<br><br>• Group A (severe disease) <br>Time to clinical improvement: Improvement will be determined according to the WHO Progression Scale. Improvement, defined by a minimum 2-step change in the scale, will be analysed as time to event, measured up to 29 days from randomisation.<br><br>• Group B (mild-moderate disease) <br>Pharmacodynamics of drug defined as time to negative viral titres in nose and/or throat swab, measured up to 29 days from randomisation.<br><br>Nomacopan Candidate-Specific Trial:<br>Time to clinical improvement: improvement will be determined according to the WHO clinical severity score (WHO Working Group on the Clinical Characteristics of COVID-19 infection 9-point ordinal scale). Improvement, defined by a minimum 2-step change in the scale, will be analysed as time to event, measured up to day 29.<br><br><br>For CST-2 (EIDD-2801): <br>To determine the safety and tolerability of multiple ascending doses of EIDD-2801.<br>Efficacy Objective: To determine the ability of EIDD-2801 to improve viral clearance (time to negative PCR).;Secondary Objective: Master Protocol:<br><br>Phase I - How safe is the treatment<br><br>Phase II: To assess the effects of study treatments on:<br>- The need for (and duration) of oxygen support (including mechanical ventilation)<br>- The length of time people remain in hospital (including time in intensive care) <br>- Clinical improvement at various timepoints <br>- Side effects seen <br><br>In addition in EIDD-2801-Candidate Specific Trial 2 <br>- Patient Reported Outcomes;Main Objective: Master Protocol:<br><br>Phase I - To find the optimal dose of each drug (candidate) (or combination of candidates) <br>Phase II - To determine the effect each candidate has on improving patients clinical outcome (using the WHO clinical severity score) and safety of each candidate and recommend whether it should be evaluated further in a large phase II/III trial.<br><br> | | | | Yes | False | | |
| → | EUCTR2020-001466-11-GR | 21 September 2020 | Prevention of severe respiratory failure in Covid-19 | suPAR-GUIDED ANAKINRA TREATMENT FOR VALIDATION OF THE RISK AND EARLY MANAGEMENT OF SEVERE RESPIRATORY FAILURE BY COVID-19: THE SAVE OPEN-LABEL, NON-RANDOMIZED SINGLE-ARM TRIAL | | Hellenic Institute for the Study of Sepsis | 14/04/2020 | 20200414 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001466-11 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 15/04/2020 | 400 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Greece | President of the Board | | 88 Michalakopoulou Street | insepsis@otenet.gr | +302107480662 | Hellenic Institute for the Study of Sepsis | Inclusion criteria: <br>• Age equal to or above 18 years<br>• Male or female gender<br>• In case of women, unwillingness to remain pregnant during the study period.<br>• Written informed consent provided by the patient or by one first-degree relative/spouse in case of patients unable to consent<br>• Confirmed infection by SARS-CoV-2 virus <br>• Findings in chest-X-ray or in chest computed tomography compatible with lower respiratory tract infection <br>• Plasma suPAR =6ng/ml<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 200<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 200<br> | Exclusion criteria: <br>• Age below 18 years<br>• Denial for written informed consent<br>• Any stage IV malignancy<br>• Any do not resuscitate decision<br>• Presence of respiratory failure<br>• Any primary immunodeficiency<br>• Less than 1,500 neutrophils/mm3<br>• Known allergy to anakinra<br>• Known allergy to trimethoprim/sulfamehoxazole<br>• Known G-6PD enzyme deficiency<br>• Oral or IV intake of corticosteroids at a daily dose equal or greater than 0.4 mg prednisone or greater the last 15 days.<br>• Any anti-cytokine biological treatment the last one month<br>• Confirmed pernicious anemia due to folic acid deficiency <br>• Severe hepatic failure<br>• Severe renal failure<br>• Pregnancy or lactation. Women of child-bearing potential will be screened by a urine pregnancy test before inclusion in the study<br> | Lower respiratory tract infection by Covid-19 at high risk for development of severe respiratory failure <br>MedDRA version: 20.0
Level: LLT
Classification code 10035738
Term: Pneumonia viral NOS
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Kineret<br>Product Name: Anakinra<br>Pharmaceutical Form: Injection<br><br>Trade Name: Bactrimel<br>Product Name: Sulfamethoxazole and Trimethoprim<br>Pharmaceutical Form: Tablet<br><br> | Main Objective: Recent data coming from the Hellenic Sepsis Study Group reveal that suPAR levels =6 ng/ml are early found among patients who will eventually develop severe respiratory failure (SRF) by Covid-19 with positive predictive value more than 80%. This signifies that an early pro-inflammatory reaction has been started in the lung. It is postulated that early anakinra treatment in these patients may halt this reaction and prevent development of SRF. In the SAVE study patients with sars-cov-2 infection with SARS-CoV-2 virus at high risk for progression to MSDs will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in SAA. ;Secondary Objective: Not applicable;Timepoint(s) of evaluation of this end point: Day 14;Primary end point(s): This is defined on day 14 as the percentage of patients who will not experience SAIs (as defined in Annex V). Patients who die before the day 14 visit are considered to have failed at the primary endpoint.→Timepoint(s) of evaluation of this end point: Day 14;Primary end point(s): This is defined on day 14 as the percentage of patients who will not experience SAIs (as defined in Annex V). Patients who die before the day 14 visit are considered to have failed at the primary endpoint.;Secondary Objective: Not applicable;Main Objective: Recent data coming from the Hellenic Sepsis Study Group reveal that suPAR levels =6 ng/ml are early found among patients who will eventually develop severe respiratory failure (SRF) by Covid-19 with positive predictive value more than 80%. This signifies that an early pro-inflammatory reaction has been started in the lung. It is postulated that early anakinra treatment in these patients may halt this reaction and prevent development of SRF. In the SAVE study patients with sars-cov-2 infection with SARS-CoV-2 virus at high risk for progression to MSDs will be detected using the suPAR biomarker. They will begin early treatment with anakinra in the effort to prevent progression in SAA. | | | | Yes | True | parent | |
| EUCTR2020-001643-13-GB | 21 September 2020 | A randomised double-blind placebo-controlled trial of Brensocatib (INS1007) in patients with severe COVID-19 | A randomised double-blind placebo-controlled trial of Brensocatib (INS1007) in patients with severe COVID-19 - STOP-COVID19: Superiority Trial Of Protease inhibition in COVID-19 | | University of Dundee | 29/04/2020 | 20200429 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001643-13 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 15/05/2020 | 300 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| United Kingdom | James Chalmers | | Division of Cardiovascular & Diabetes Medicine | j.chalmers@dundee.ac.uk | 01382 383642 | University of Dundee | Inclusion criteria: <br>• Male or female<br>• =16 years of age<br>• SARS-CoV-2infection (clinically suspected+ or laboratory confirmed*).<br>• Admitted to hospital as in-patient less than 96 hours prior to randomisation^<br>• Illness of any duration, and at least one of the following:<br>o Radiographic infiltrates by imaging (e.g. chest x-ray, computed tomography (CT) scan) <br>OR<br>o Evidence of rales/crackles on physical examination<br>OR<br>o Peripheral capillary oxygen saturation (SpO2) =94% on room air prior to randomization<br>OR<br>o Requiring supplemental oxygen.<br>OR<br>o Lymphocyte count <1 x 109 cells per litre (L)<br>• Participant (or legally authorized representative) provides written informed consent <br>• Able to take oral medication<br>• Participant (or legally authorised representative) understands and agrees to comply with planned trial procedures.<br>*Laboratory-confirmed: SARS-CoV-2 infection as determined by polymerase chain reaction (PCR), or other commercial or public health assay in any specimen < 96 hours prior to randomization.<br>+Clinically suspected: in general, SARS-CoV-2 infection should be suspected when a patient presents with (i) typical symptoms (e.g. influenza-like illness with fever and muscle pain, or respiratory illness with cough and shortness of breath); and (ii) compatible chest X-ray findings (consolidation or ground-glass shadowing); and (iii) alternative causes have been considered unlikely or excluded (e.g. heart failure, influenza). However, the diagnosis remains a clinical one based on the opinion of the managing doctor<br>^Where a patient has been admitted to hospital for a non COVID-19 reason and develops COVID-19 symptoms whilst an in-patient, randomisation my occur up to 96 hours from onset of symptoms.<br><br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: 20<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 100<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 180<br> | Exclusion criteria: <br>• Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 5 times the upper limit of normal, result within 72 hours of randomization (the result closest to randomization should be used if several results are available).<br>• History of severe liver disease<br>• Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30), result within 72 hours of randomization (the result closest to randomization should be used if several results are available)<br>• Absolute neutrophil count less than 1.0 x 109 cells per L within 72 hours of randomization (the result closest to randomization should be used if several results are available)<br>• Current treatment with Itraconazole, Ketoconazole, diltiazem, verapamil, phenytoin or rifampicin<br>• HIV treatments - current treatment with protease/integrase inhibitors or non-nucleoside reverse transcriptase inhibitors*<br>• Pregnant or breast feeding.<br>• Anticipated transfer to another hospital which is not a trial site within 24 hours.<br>• Allergy to Brensocatib<br>• Use of any investigational drug within five times of the elimination half-life after the last trial dose or within 30 days, whichever is longer. Co-enrolment with COVID-19 trials is allowed as per co-enrolment agreements and/or individual decision by the CI.<br>Women of child-bearing potential must be willing to have pregnancy testing prior to trial entry. <br>*The Liverpool HIV checker (https://www.hiv-druginteractions.org/checker) should be used to check for any HIV drug interactions. Simvastatin could be used as a surrogate for Brensocatib as it metabolised similarly by CYP 3A4 pathway.<br><br><br> | COVID-19 <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Brensocatib<br>Product Code: INS1007<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: Brensocatib<br>CAS Number: 1802148-05-5<br>Current Sponsor code: INS1007<br>Other descriptive name: AZD7986<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 25-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: Up to day 29;Primary end point(s): Clinical status on 7-point ordinal scale:<br>1. Not hospitalised, no limitations on activities<br>2. Not hospitalised, limitation on activities;<br>3. Hospitalised, not requiring supplemental oxygen;<br>4. Hospitalised, requiring supplemental oxygen;<br>5. Hospitalised, on non-invasive ventilation or high flow oxygen devices;<br>6. Hospitalised, on invasive mechanical ventilation or ECMO (Extracorporeal membrane oxygenation)<br>7. Death.<br>;Secondary Objective: Evaluate the safety of the intervention through 28 days of follow-up as compared to the control arm<br>Quality of life;Main Objective: The overall objective of the study is to evaluate the clinical efficacy of Brensocatib compared to placebo on top of standard care in adult patients hospitalized with COVID-19 | | | | Yes | True | parent | |
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| EUCTR2020-001722-66-ES | 28 September 2020 | Plasma turnover in patients with COVID-19 disease and invasive mechanical ventilation | Plasma turnover in patients with COVID-19 disease and invasive mechanical ventilation: a randomized study - REP-COVID | | Fundació Clínic per a la recerca Biomèdica | 27/04/2020 | 20200427 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001722-66 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 23/04/2020 | 116 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | CTU | | Mallorca 183 | acruceta@clinic.cat | 00349322754004380 | Clinical Trial Unit | Inclusion criteria: <br>1-Age 18-79 years;<br><br>2-Diagnosis of COVID-19 by PCR in nasopharyngeal, sputum or bronchial aspirate smears :<br><br>3-Admission to ICU with invasive mechanical ventilation;<br><br>4-Telephone informed consent granted by family members or legal representative.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 91<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 25<br> | Exclusion criteria: <br>1-> 7 days of invasive mechanical ventilation, 2- Refractory shock (norepinephrine> 0.5 microg / Kg / min), 3- Decompensated liver cirrhosis 4- Chronic hemodialysis 5- Active neoplastic disease 6- Moderate or severe heart failure (NYHA III- IV), 7- Moderate-severe lung disease (GOLD III-IV), 8- HIV with AIDS criteria.<br> | coronavirus (covid-19) infection with respiratory failure requiring mechanical ventilation. <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
<br>MedDRA version: 21.1
Level: PT
Classification code 10067221
Term: Mechanical ventilation
System Organ Class: 10042613 - Surgical and medical procedures
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Albutein 5% solutión for infusion<br>Product Name: Human Albumin<br>Product Code: B05AA01<br>Pharmaceutical Form: Solution for infusion<br>INN or Proposed INN: HUMAN SERUM ALBUMIN<br>Other descriptive name: ALBUMIN NORMAL HUMAN SERUM<br>Concentration unit: g/ml gram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 40-<br><br>Trade Name: Flebogamma DIF/100 Human Inmunoglobulin normal<br>Product Name: Human Immunoglobuline normal<br>Product Code: Flebogamma DIF 50 mg/ml solución para perfusión<br>Pharmaceutical Form: Solution for infusion<br>INN or Proposed INN: Human normal immunoglobulin<br>Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN<br>Concentration unit: mg/kg milligram(s)/kilogram<br>Concentration type: equal<br>Concentration number: 100-<br><br> | Secondary Objective: 1– Evaluate survival variables<br>2– Time in which mechanical ventilation, vasoactive support and renal support have been necessary.<br>3- Days of ICU stay, days of hospitalization.<br>4- Evaluation of the degree of organic failure (s) by daily calculation of SOFA and APACHE score during the intervention period (from day 1 to day 7), at discharge from the ICU and from the hospital.<br>5- Measure the basic systemic inflammatory response.<br>6- Measure the inflammatory response of advanced inflammatory serum mediators.<br>7. Evaluate which blood components and molecular pathways are altered and the impact of plasma turnover.<br>8- Safety variables and adverse events related or not to treatment during its administration period.;Timepoint(s) of evaluation of this end point: Impact of plasma exchange on the rate and probability of survival 28 days after inclusion.;Primary end point(s): Impact of plasma exchange on the rate and probability of survival 28 days after inclusion.;Main Objective: To assess the impact of plasma exchange on mortality at 28 days in patients with covid-19 disease and invasive mechanical ventilation. | | | | No | True | parent | |
| → | EUCTR2020-001505-22-ES | 28 September 2020 | Efficacy and safety evaluation of umbilical cord mesenchymal stem cells for the treatment of patients with respiratory failure due to coronavirus (COVID-19) | Double-blind, randomized, parallel, placebo-controlled pilot clinical trial, nested in a prospective cohort observational study, for the evaluation of the efficacy and safetyof two doses of WJ-MSC in patients with acute respiratory distress syndrome secondary to infection by COVID-19 - COVIDMES | | Banc de Sang i Teixits | 27/04/2020 | 20200427 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001505-22 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 23/04/2020 | 30 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: yes<br>Other trial design description: Nested in a prospective cohort observational study<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | Banc de Sang i Teixits | | Passeig Taulat, 116 | rucoll@bst.cat | 349355735006707 | Banc de Sang i Teixits | Inclusion criteria: <br>1. Participation in the prospective observational epidemiological study CIBERESUCICOVID (PCR for SARS-CoV-2 positive, ICU admission)<br>2. Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg < PaO2/FiO2 = 200 mmHg) <br>3. Male or female, aged 18 to 70 years old<br>4. Signed informed consent by the patient or by a legal representative<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 20<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 10<br> | Exclusion criteria: <br>1. Expected survival less than 3 days<br>2. Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed<br>3. Neoplastic disease either active or without complete remission <br>4. Immunosuppressed patients (except treatment with corticosteroids for respiratory distress)<br>5. Pregnant or lactating women<br>6. Participation in another clinical trial with an experimental drug in the last 30 days<br>7. Other pathologies that, in medical judgment, contraindicate participation in the study<br> | Acute respiratory distress syndrome <br>MedDRA version: 21.1
Level: PT
Classification code 10001052
Term: Acute respiratory distress syndrome
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: XCEL-UMC-BETA<br>Pharmaceutical Form: Solution for infusion<br>INN or Proposed INN: EX VIVO EXPANDED WHARTON'S JELLY DERIVED MESENCHYMAL STEM CELLS<br>Current Sponsor code: XCEL-UMC-BETA<br>Other descriptive name: EX VIVO EXPANDED WHARTON'S JELLY DERIVED MESENCHYMAL STEM CELLS<br>Concentration unit: IU/kg international unit(s)/kilogram<br>Concentration type: range<br>Concentration number: 700000-1000000<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br> | Main Objective: All-cause mortality at day 28;Secondary Objective: 1- To assess the safety and feasibility of WJ-MSC administration compared to placebo in the treatment of patients with SARS-CoV-2 infection and ARDS<br>2- Need for treatment with rescue medication<br>3- Need and duration of mechanical ventilation<br>4- Ventilator free days<br>5- Evolution of PaO2 / FiO2 ratio at 3, 5, 7, 14, 21 and 28 days after starting treatment<br>6- Evolution of the SOFA index at 3, 5, 7, 14, 21 and 28 days after starting treatment<br>7- Evolution of the APACHE II score at 3, 5, 7, 14, 21 and 28 days after starting treatment<br>8- Duration of hospitalization <br>9- Evolution of disease biomarkers: RT-PCR, LDH, D-dimer and Ferritin at 3, 5, 7, 14, 21 y 28 after starting treatment<br>10- Evolution of markers of immune response (leucocyte count, neutrophils) at 3, 5, 7, 14, 21 y 28 days after starting treatment;Timepoint(s) of evaluation of this end point: Day 28;Primary end point(s): Number of patients who died on day +28, by treatment group→Primary end point(s): Number of patients who died on day +28, by treatment group;Main Objective: All-cause mortality at day 28;Secondary Objective: 1- To assess the safety and feasibility of WJ-MSC administration compared to placebo in the treatment of patients with SARS-CoV-2 infection and ARDS<br>2- Need for treatment with rescue medication<br>3- Need and duration of mechanical ventilation<br>4- Ventilator free days<br>5- Evolution of PaO2 / FiO2 ratio at 3, 5, 7, 14, 21 and 28 days after starting treatment<br>6- Evolution of the SOFA index at 3, 5, 7, 14, 21 and 28 days after starting treatment<br>7- Evolution of the APACHE II score at 3, 5, 7, 14, 21 and 28 days after starting treatment<br>8- Duration of hospitalization <br>9- Evolution of disease biomarkers: RT-PCR, LDH, D-dimer and Ferritin at 3, 5, 7, 14, 21 y 28 after starting treatment<br>10- Evolution of markers of immune response (leucocyte count, neutrophils) at 3, 5, 7, 14, 21 y 28 days after starting treatment;Timepoint(s) of evaluation of this end point: Day 28 | | | | No | False | | |
| EUCTR2020-001541-39-ES | 28 September 2020 | Pilot study of bevacizumab as a treatment for respiratory distress in patients with COVID-19 | Pilot study of single-dose bevacizumab as a treatment for acute respiratory distress syndrome in patients with COVID-19 | | Fundación para la Investigación Biomédica de Córdoba | 27/04/2020 | 20200427 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001541-39 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 24/04/2020 | 22 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>Other trial design description: Pilot study<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | Antonio Luque | | Edificio IMIBIC - Avenida Menéndez Pidal s/n | uicec@imibic.org | 0034671596070 | Fundación para la Investigación Biomédica de Córdoba | Inclusion criteria: <br>1. Age = 18 and <90 years<br>2. Diagnosis confirmed by COVID-19 PCR<br>3. Radiological image compatible with bilateral non-cardiogenic pleuropulmonary exudate<br>4. Having received antiviral and anti-inflammatory therapy according to the protocol of the Reina Sofía University Hospital in Córdoba<br>5. Present any of the following clinical-functional criteria:<br>5.a. Respiratory distress: Tachypnea> 30 breaths / minute<br>5.b. Partial arterial oxygen pressure (PaO2) / Inspiration fraction (FiO2) = 300 mmHg<br>6. Signature of direct or delegated informed consent<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 10<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 12<br> | Exclusion criteria: <br>1. Severe liver dysfunction (Child Pugh = 3 or AST> 5 times normal)<br>2. Severe renal dysfunction with glomerular filtration <30 mL / minute or in treatment with hemodialysis or peritoneal dialysis)<br>3. Poorly controlled arterial hypertension (TAs> 160 mmHg or TAd <100 mmHg) or having a previous history of hypertensive crisis or hypertensive encephalopathy<br>4. History of poorly controlled heart disease with a NYHA> 2<br>5. History of thrombosis the previous 6 months<br>6. Signs of active bleeding<br>7. Open wounds, gastrointestinal perforation fractures<br>8. Diagnosis of thrombophilic diseases or bleeding diathesis<br>9. Active viral hepatitis or HIV not adequately treated<br>10. Intolerance or allergy to bevacizumab or its components<br>11. Pregnancy<br> | Acute respiratory distress syndrome in patients with COVID-19 <br>MedDRA version: 21.1
Level: PT
Classification code 10001052
Term: Acute respiratory distress syndrome
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
<br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Avastin<br>Pharmaceutical Form: Solution for infusion<br>INN or Proposed INN: BEVACIZUMAB<br>CAS Number: 216974-75-3<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 25-<br><br> | Main Objective: - To evaluate the crude mortality rate at 28 days.;Secondary Objective: - To evaluate the improvement in the PaO2 / FiO2 ratio at 24 hours, at 72 hours, at 7 days, 14 days and 28 days.<br>- To evaluate the improvement in the degree of dyspnea at 72 hours and at 7 days according to the Likert scale (-3 to +3).<br>- To evaluate the improvement of the radiological findings by (simple radiology) at 72 hours and at 7 days.<br>- To evaluate the improvement in transcutaneous O2 saturation at 24 hours, at 72 hours and at 7 days.<br>- To evaluate the improvement in PaO2.<br>- To measure the decrease in mortality (crude rate per month).<br>- To evaluate the toxicity of the established strategy.;Primary end point(s): 1. Crude mortality at 28 days.;Timepoint(s) of evaluation of this end point: 28 days after the inclusion of the patient. | | | | No | False | | |
| EUCTR2020-001618-39-ES | 28 September 2020 | Study to evaluate the efficacy and tolerability of treatment with vafidemstat in combination with standard of care treatment to prevent Acute Respiratory Distress Syndrome in adult severely ill patients with COVID-19. | A Phase II, randomized, open–label study to evaluate the efficacy and tolerability of treatment with vafidemstat in combination with standard of care treatment to prevent Acute Respiratory Distress Syndrome (ARDS) in adult severely ill patients with COVID-19. | | Oryzon Genomics S. A. | 27/04/2020 | 20200427 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001618-39 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 24/04/2020 | 40 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | Sonia Gutiérrez | | Sant Ferran 74 | sgutierrez@oryzon.com | +34 647 796 923 | Oryzon Genomics S. A. | Inclusion criteria: <br>1) Adult, age >=18 years<br>2) Laboratory (RT-PCR) confirmed 2019-nCoV infection in throat swab and/or sputum and/or lower respiratory tract samples, no more than 72h before randomization to study treatment <br>3) Patients admitted to hospital ward and at risk of ADRS or respiratory failure which will require mechanical ventilation<br>4) Severity of symptoms 3-4 according to WHO 7-point Global Overall Symptom scale (measures severity symptoms in clinical trials)<br>- Severity 3 – Hospitalized NO requiring supplemental oxygen <br>- Severity 4 - Hospitalized requiring supplemental oxygen<br>5) Confirmed CoVID-19 pneumonia diagnosis/bilateral pulmonary infiltrate of any severity, with = 72h duration and meeting at least one of the following criteria for severe condition:<br>- X-Ray progression (Pulmonary X-Ray with increased extension or increased number of infiltrates at control) <br>- IL-6 elevation<br>- Increase in at least one of the following systemic and pulmonary inflammatory biomarkers: <br> - D-dimer >1000 µg/L<br> - PCR > 5 mg/dL<br> - LDH >300 UI/L<br> - Ferritin >200 ng/mL<br> - Total Lymphocytes <1000 /mL<br>6) Ideally, treatment can be started no more than 5-7 days since the onset of symptoms <br>7) Sign the Informed Consent Form on a voluntary basis<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 20<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 20<br> | Exclusion criteria: <br>1) Platelets <150000/mm3<br>2) Neutrophils <1500/mm3<br>3) Mechanical ventilation that prevents administration of vafidemstat oral treatment<br>4) Investigator considers patient unsuitable<br>5) Women who are pregnant or breast-feeding (*)<br>*Fertile male and female must use highly efficient contraception until 30 days after last dose of the study treatment, defined as:<br>- A method with less than 1% failure rate (e.g. permanent sterilization, hormone implants, hormone injections, some intrauterine devices, or vasectomised partner) <br>OR<br>- The use of two methods of contraception [(one barrier method [condom, diaphragm or cervical/vault caps] with spermicide and one hormonal contraceptive (e.g., combined oral contraceptives, patch, vaginal ring, injectable and implants)]<br><br> | Acute Respiratory Distress Syndrome (ARDS) <br>MedDRA version: 21.1
Level: LLT
Classification code 10003083
Term: ARDS
System Organ Class: 100000004855
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Vafidemstat<br>Product Code: ORY-2001<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: VAFIDEMSTAT<br>CAS Number: 1357247-95-0<br>Concentration unit: mg milligram(s)<br>Concentration type: range<br>Concentration number: 1.2-2.4<br><br> | Main Objective: To investigate the efficacy of vafidemstat, in combination with standard of care treatment (e.g., hidroxihidroxichloroquine, lopinavir/ritonavir, azithromycin, or any other being applied by the Hospitals according to the current guides) to prevent Acute Respiratory Distress Syndrome (ARDS) in adult severely ill patients with CoVID-19.;Secondary Objective: To evaluate the tolerability of vafidemstat, in combination with standard of care treatment (e.g., chloroquine, lopinavir/ritonavir, azithromycin, or any other being applied by the Hospitals according to the current guides), to prevent Acute Respiratory Distress Syndrome (ARDS) in adult severely ill patients with CoVID-19.;Primary end point(s): • Reduction in the incidence of patients (%) requiring mechanical ventilation and referral to ICU within the period from Day 1 (i.e.: first study drug administration) to Day 14 <br><br>• Decrease in global mortality and mortality associated to CoVID-19 pneumonias within the period from Day 1 (i.e.: first study drug administration) to Day 14;Timepoint(s) of evaluation of this end point: 14 days | | | | No | False | | |
| → | EUCTR2020-000705-86-ES | 28 September 2020 | Control of inflammatory parameters with fish oil in parenteral nutrition | Control of inflammatory parameters with omega-3 fatty acid supplementation in adult patients with parenteral nutrition and respiratory infection by SARS-CoV-2: randomized clinical trial COVID-19 | | VALL HEBRON UNIVERSITY HOSPITAL | 05/05/2020 | 20200505 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-000705-86 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 26/04/2020 | 117 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 3<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Spain | DAVID BERLANA | | VALL HEBRON 119 | dberlana@vhebron.net | +34654431619 | VALL HEBRON UNIVERSITY HOSPITAL | Inclusion criteria: <br>• Age = 18 years.<br>• Patients with at least 5 days of PN.<br>• Baseline liver parameters before PN: GGT, alkaline phosphatase < 100 U/dL and direct bilirubin <1.2 mg/dL al inicio de NP.<br>• Liver parameter alterations: GGT = 300 U/dL, alkaline phosphatase = 200 U/dL or direct bilirubin =1.8 mg/dL<br>• Forseeing to receive at least 5 days of PN. <br>• Admitted in the ICU of the Valle Hebron University Hospital<br>• Willing to give their IC in writing for the trial and be able to do so.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 117<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 117<br> | Exclusion criteria: <br>- Lipids administration contraindicated<br>- Have a history of hypersensitivity of idiosincratic reactions to any component of intravenous lipid emulsions.<br>- Home parenteral nutrition patients<br>- Liver transplantation<br>- Liver parameters alterations before PN: 20% above upper normal values. <br>- Patients rejection to participate.<br> | Critically ill adult patients with parenteral nutrition and respiratory infection by SARS-COV-2;Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18] | <br>Trade Name: SMOFLIPID<br>Product Name: TPN with emulsions enriched with omega-3 fatty acid<br>Pharmaceutical Form: Emulsion for infusion<br>INN or Proposed INN: aceite de soja, triglicéridos de cadena media, aceite de oliva y aceite de pescado<br>CAS Number: 66581<br>Other descriptive name: LONG-CHAIN TRIGLYCERIDES<br>Concentration unit: % (W/V) percent weight/volume<br>Concentration type: equal<br>Concentration number: 20-<br><br>Trade Name: CLINOLEIC<br>Product Name: TPN with emulsions enriched with omega-3 fatty acid<br>Pharmaceutical Form: Emulsion for infusion<br>INN or Proposed INN: Aceite de oliva purificado y aceite de soja purificado<br>CAS Number: 66971<br>Other descriptive name: LONG-CHAIN TRIGLYCERIDES<br>Concentration unit: % (W/V) percent weight/volume<br>Concentration type: equal<br>Concentration number: 20-<br><br>Trade Name: OMEGAVEN<br>Product Name: TPN with emulsions enriched with omega-3 fatty acid<br>Pharmaceutical Form: Emulsion for infusion<br>INN or Proposed INN: Acidos grasos omega-3<br>Other descriptive name: OMEGA-3-FATTY ACIDS 90<br>Concentration unit: % (W/V) percent weight/volume<br>Concentration type: equal<br>Concentration number: 10-<br><br>Trade Name: NUTRIFLEX LIPID SPECIAL<br>Product Name: NUTRIFLEX LIPID SPECIAL<br>Pharmaceutical Form: Solution for infusion<br>INN or Proposed INN: Solucion de aminoacidos<br>CAS Number: 62987<br>Other descriptive name: ESSENTIAL AMINO ACIDS<br>Concentration unit: % (W/V) percent weight/volume<br>Concentration type: equal<br>Concentration number: 56-<br>INN or Proposed INN: Solucion de glucosa anhidra<br>CAS Number: 62987<br>Other descriptive name: GLUCOSE ANHYDROUS PH EUR<br>Concentration unit: % (W/V) percent weight/volume<br>Concentration type: equal<br>Concentration number: 158-<br>INN or Proposed INN: Aceite de soja refinado y MCT<br>CAS Number: 62987<br>Other descriptive name: LONG-CHAIN TRIGLYCERIDES<br>Concentration unit: % (W/V) p | Timepoint(s) of evaluation of this end point: Inclusion day and end of PN.;Primary end point(s): Primary end point is the change of liver function parameters: GGT ; from the value the day of inclusion to the end of PN.;Secondary Objective: To analyze wether the use of PN with a 30% of omega-3 fatty acids is effective in reducing the infection rate, hyperglycemia rate, hypertrygliceridemia rate, ICU and hospital length of stay. As well as to study the differences in farnesoid-X receptor expression depending on the type of lipid received.;Main Objective: In critically adult patients with parenteral nutrition with liver impairment related to parenteral nutrition, the main objective is to determinate wether the change to lipidic emulsion (with a 30% omega-3 fatty acids) is effective in reducing th liver impairment, measured as gamma-glutamyl-transferase (GGT)→Main Objective: In critically adult patients with parenteral nutrition with liver impairment related to parenteral nutrition, the main objective is to determinate wether the change to lipidic emulsion (with a 30% omega-3 fatty acids) is effective in reducing th liver impairment, measured as gamma-glutamyl-transferase (GGT);Secondary Objective: To analyze wether the use of PN with a 30% of omega-3 fatty acids is effective in reducing the infection rate, hyperglycemia rate, hypertrygliceridemia rate, ICU and hospital length of stay. As well as to study the differences in farnesoid-X receptor expression depending on the type of lipid received.;Primary end point(s): Primary end point is the change of liver function parameters: GGT ; from the value the day of inclusion to the end of PN.;Timepoint(s) of evaluation of this end point: Inclusion day and end of PN. | | | | No | False | | |
| EUCTR2020-001825-29-ES | 28 September 2020 | CLINICAL TRIAL OF THE USE OF ANAKINRA (ANTI IL-1) IN CYTOKINE STORM SYNDROME (CSS) SECONDARY TO COVID-19 | CLINICAL TRIAL OF THE USE OF ANAKINRA (ANTI IL-1) IN CYTOKINE STORM SYNDROME (CSS) SECONDARY TO COVID-19 - ANA-COVID-GEAS | | NAVARRABIOMED - FUNDACIÓN MIGUEL SERVET | 05/05/2020 | 20200505 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001825-29 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 28/04/2020 | 180 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: WITHOUT ANAKINRA<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Spain | RUTH GARCIA | | EDIFICIO LUNA, COMPLEJO HOSPITALARIO DE NAVARRA, C/IRUNLARREA Nº 3 | ruth.garcia.rey@navarra.es | 0034848422163 | CLINICAL TRIAL UNIT | Inclusion criteria: <br>? Age 18-80 years.
<br>? Severe pneumonia COVID-19 defined as:
<br>o Nasopharyngeal smear with RCP positive for SARS-CoV-2
<br>o X-Rays (or other technique) pulmonary infiltrates compatible with pneumonia.
<br>o 1 or more of the following criteria:
<br>? Ambient air oxygen saturation <= 94% measured with a pulse oximeter.
<br>? Pa:FiO2 (partial pressure O2/fraction of inspired O2) <=300.
<br>? Sa:FiO2 (O2 saturation measured with pulse oximeter/ fraction of inspired O2) <=350.
<br>?High suspicion of CSS that could resemble MAS-like: represented by IL-6 values > 40 pg/mL and/or ferritin >500 ug/L and/or PCR > 30 mg/L (rationale: = 5 upper normal limit) and/or LDH >300 UI/L. We have chosen these parameters because they are implemented in all the participating hospitals, they are a reflection of the cytokine storm and they have also been significant in terms of predicting mortality in patients with COVID-19 (9).
<br>? Written informed consent. The protocol will be explained to the patient in front of a nurse who will act as a legal witness by signing the document on behalf of the patient.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 100<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 80<br> | Exclusion criteria: <br>? Need for oro-tracheal intubation and/or invasive mechanical ventilation at the start of the study.
<br>? AST/ALT with values greater than 5 times normal levels.
<br>? Neutrophils < 1500 cell/mmc.
<br>? Platelets < 50.000 cell/mmc.
<br>? Sepsis or pneumonia documented by other pathogens than SARS-CoV-2.
<br>? Existence of any life-threatening comorbidity or any other medical condition that, in the investigator's opinion, makes the patient unsuitable for inclusion.
<br>? Inability to obtain informed consent.
<br>? Positivity for HBV, HCV or tuberculin test serology.
<br>? Pregnancy.
<br>? Use of other previous or concomitant biological treatments. Patients in concomitant treatment with other biologicals that may interfere will be excluded: tocilizumab, canakinumab, TNFalfa inhibitors, JAKiinibs
<br>? Severe renal dysfunction (estimated glomerular filtration rate = 30 ml / min / 1.73 m2) or receive continuous renal replacement therapy, hemodialysis or peritoneal dialysis.
<br>? Uncontrolled hypertension (sitting systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg).
<br>? Administration of plasma from convalescent patients who have recovered from SARS-CoV-2 infection.
<br>? History of hypersensitivity or allergy to any component of the study drug.
<br>? Enrollment in another concurrent intervention clinical trial, or intake of an investigational medication within three months or 5 half-lives prior to inclusion in this study, if deemed to interfere with the objectives of this study as assessed by the investigator.
<br>? Predictable inability to cooperate with given instructions or study procedures.<br> | Hyperinflammation and respiratory distress in patients with SARS- CoV-2;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: ANAKINRA<br>Pharmaceutical Form: Solution for injection in pre-filled syringe<br>INN or Proposed INN: ANAKINRA<br>CAS Number: 143090-92-0<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 400-<br><br>Trade Name: HYDROXYCHLOROQUINE<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Hydroxychloroquine<br>CAS Number: 118-42-3<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 400-<br><br>Trade Name: LOPINAVIR/RITONAVIR<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: LOPINAVIR/RITONAVIR<br>Other descriptive name: LOPINAVIR/RITONAVIR<br>Concentration unit: mg milligram(s)<br>Concentration type: range<br>Concentration number: 800-200<br><br>Trade Name: AZYTHROMICINE<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: AZITHROMYCIN DIHYDRATE<br>Other descriptive name: AZITHROMYCIN DIHYDRATE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 500-<br><br> | Main Objective: To assess the effect of anakinra in addition to standard treatment on the need for mechanical ventilation in patients with severe COVID-19 and CSS pneumonia.;Secondary Objective: To assess the effect of anakinra in addition to standard treatment on mortality in patients with severe COVID-19 and CSS pneumonia.;Primary end point(s): Treatment success, defined as number of patients not requiring mechanical ventilation by Day 15.<br>Number of patients not requiring mechanical ventilation (day 28).? Time to mechanical ventilation (days)<br>? Time to oxygen saturation normalization<br>? Stay in ICU and hospitalization (days);Timepoint(s) of evaluation of this end point: 15 days | | | | No | False | | |
| EUCTR2020-001697-30-ES | 28 September 2020 | PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE IN SANITARIES HIGHLY EXPOSED TO COVID-19. (COVIDNA) | PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE IN SANITARIES HIGHLY EXPOSED TO COVID-19. (COVIDNA) - COVIDNA | | NAVARRABIOMED - FUNDACIÓN MIGUEL SERVET | 07/05/2020 | 20200507 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001697-30 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 23/04/2020 | 200 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: WITH OUT TREATMENT/PROPHYLAXIS<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Spain | RUTH GARCÍA | | EDIFICIO LUNA, COMPLEJO HOSPITALARIO DE NAVARRA, C/IRUNLARREA Nº 3 | ruth.garcia.rey@navarra.es | 0034848422163 | CLINICAL TRIAL UNIT | Inclusion criteria: <br>1. Sanitary with high exposure to COVID-19 with training of doctor or DUE belonging to the health network of Navarra<br>2. No previous diagnosis of COVID-19<br>3. Not present symptoms compatible with COVID-19, neither present nor past<br>4. Negative Ig M or Ig G negative immunochromatography test result for both<br>5. You agree not to self-medicate with chloroquine, hydroxychloroquine, or other potential antivirals.<br>6. That they give their written informed consent to participate in the trial<br>7. Not being pregnant. To do this, if you suspect that you might be, you should have previously had a pregnancy test.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 200<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>1. Hypersensitivity to chloroquine or derivatives.<br>2. Contraindication to taking hydroxychloroquine (for epilepsy, severe kidney failure (clearance <10 ml / min), severe liver failure).<br>3. Known retinopathy.<br>4. Impossibility to continue in the trial during the 6 weeks of treatment.<br>5. Taking concomitant contraindicated medication: aremeter / lumefantrine and mefloquine as antimalarials, natalizumab, pimecrolimus and tacroliums, moxifloxacin, agasidase alfa and beta, dapsone, tratuzumab, drugs that lengthen QT such as digoxin, amiodarone and some beta blockers.<br>6. Pregnancy or pregnancy wish in the next 6 weeks.<br>7. Glucose 6-Phosphate Dehydrogenase deficiency that generates hereditary hemolytic anemia.<br> | PRE-EXPOSURE PROPHYLAXIS WITH HYDROXYCHLOROQUINE IN SANITARIES HIGHLY EXPOSED TO COVID-19;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: HYDROXYCHLOROQUINE<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Hydroxychloroquine<br>CAS Number: 118-42-3<br>Concentration unit: Bq/mg becquerel(s)/milligram<br>Concentration type: equal<br>Concentration number: 200-<br><br> | Timepoint(s) of evaluation of this end point: 6 WEEKS;Primary end point(s): ? Appearance of Ig M in rapid test YES / NO<br>? Appearance of Ig G in rapid test YES / NO<br>? Appearance of symptoms compatible with COVID-19: fever, cough, odynophagia, vomiting or diarrhea, headache, anosmia or hyposmia, ageusia or dysgeusia without any other alternative diagnosis<br>? Positive PCR with compatible symptoms carried out in occupational risks (YES / NO);Main Objective: To assess the efficacy and safety of 155 mg of hydroxychloroquine base as prophylaxis in health professionals subjected to repeated exposures to the COVID-19 virus, to reduce the contagion measured as development of Ig M antibodies. Professionals must be negative for the disease at the beginning of the randomized study.;Secondary Objective: ? Assess whether there are differences between the two groups in the severity of the disease if IgM antibodies appear. Gravity will be measured as:<br>o Duration of symptoms<br>o Development of viral pneumonia<br>o Specify hydroxychloroquine dose increase<br>o Increased antiviral medication (kaletra ... etc) during the study.<br>o Need for hospital admission<br>o ICU admission<br>? Assess the clinical safety of hydroxychloroquine in subjects without comorbidities and its QTc lengthening effect.<br>? Assess in both groups whether the appearance of Ig G antibodies protects against the new appearance of disease understood as the appearance of new IgM antibodies in the period studied.<br>? Estimation of the percentage of these toilets that have been able to pass the oligosymptomatic disease (Ig M or Ig G positive) in the initial sampling of healthy candidates. | | | | No | False | | |
| → | EUCTR2020-001376-15-DE | 28 September 2020 | A study to investigate whether vaccination with VPM1002 can reduce the sick days of healthcare professionals during the SARS-CoV-2 pandemic | A phase III, double-blind, randomized, placebo-controlled multicentre clinical trial to assess the efficacy and safety of VPM1002 in reducing healthcare professionals’ absenteeism in the SARS-CoV-2 pandemic by modulating the immune system | | Vakzine Projekt Management GmbH | 06/04/2020 | 20200406 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001376-15 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 13/05/2020 | 1200 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Germany | Clinical Trial Information | | Mellendorfer Strasse 9 | info@vakzine-manager.de | +495111699080 | Vakzine Projekt Management GmbH | Inclusion criteria: <br>• Adult (=18 years)<br>• Male or female<br>• Healthcare professionals taking care of potentially SARS-CoV-2 infected patients<br>• Subject is contractually capable, able to understand information on study and has signed informed consent sheet<br>• Subject has access to an internet-enabled electronic device<br>• Women of childbearing potential (WOCBP) who are currently using reliable methods of birth control, have a negative pregnancy test during screening and have no intention to become pregnant for at least 3 months post-vaccination.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 1080<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 120<br> | Exclusion criteria: <br>• Known hypersensitivity or allergy to (components of) the VPM1002 vaccine or serious adverse reactions to prior BCG administration<br>• Known active or latent Mycobacterium tuberculosis infection or with another mycobacterial species. A history with or suspicion of M. tuberculosis infection.<br>• Fever (>38 °C) within the past 24 hours<br>• Pregnant or breast-feeding<br>• Suspicion of active viral or bacterial infection<br>• Participation of subject in another interventional study within 30 days before screening<br>• Person is an employee of the sponsor, a relative of the investigator or in direct reporting line to clinical trial staff at the clinical trial site<br>• Severely immunocompromised subjects, such as: <br>a) subjects with known infection with the human immunodeficiency virus (HIV); <br>b) subjects with solid organ transplantation; <br>c) subjects with bone marrow transplantation; <br>d) subjects under chemotherapy, immunotherapy and radiotherapy; <br>e) subjects with primary immunodeficiency; <br>f) treatment with any anti-cytokine therapies; <br>g) treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months<br>• Active solid or non-solid malignancy or lymphoma in the past 5 years<br>• Direct involvement in the design or the execution of the present clinical trial<br>• Expected absence from work of =4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc)<br>• Employment of less than 50% a full-time equivalent<br>• Previous positive SARS-CoV-2 test result<br> | infectious respiratory diseases (e.g. COVID-19) <br>MedDRA version: 20.0
Level: HLGT
Classification code 10024970
Term: Respiratory tract infections
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: VPM1002<br>Pharmaceutical Form: Lyophilisate for suspension for injection<br>INN or Proposed INN: VPM1002<br>Current Sponsor code: VPM1002<br>Other descriptive name: Recombinant Mycobacterium bovis rBCG?ureC::hly; VPM1002<br>Concentration unit: CFU/ml colony forming unit(s)/millilitre<br>Concentration type: range<br>Concentration number: 2000000-8000000<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intradermal use<br><br> | Main Objective: To assess the reduction of absenteeism among HCPs with direct patient contacts during the epidemic phase of COVID-19.;Secondary Objective: To assess the incidence of SARS-CoV-2 infection or symptoms of infection, reduction of hospital admission, ICU admission or death in HCPs with direct patient contacts during the epidemic phase of COVID-19.;Primary end point(s): Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection);Timepoint(s) of evaluation of this end point: From day 0 to day 240→Timepoint(s) of evaluation of this end point: From day 0 to day 240;Primary end point(s): Number of days absent from work due to respiratory disease (with or without documented SARS-CoV-2 infection);Secondary Objective: To assess the incidence of SARS-CoV-2 infection or symptoms of infection, reduction of hospital admission, ICU admission or death in HCPs with direct patient contacts during the epidemic phase of COVID-19.;Main Objective: To assess the reduction of absenteeism among HCPs with direct patient contacts during the epidemic phase of COVID-19. | | | | Yes | False | | |
| EUCTR2020-002728-35-HU | 28 September 2020 | Clinical trial of Favipiravir treatment of patients with COVID-19 | An Investigation of the Efficacy and Safety of Favipiravir in COVID-19 Patients with Mild Pneumonia
- An open-label randomized controlled study -
| | Hungarian Ministry of Innovation and Technology - Representative: Hecrin Consortium | 13/08/2020 | 20200813 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002728-35 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 17/09/2020 | 150 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Supportive care (symptomatic therapy)<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Hungary | CRO | | Völgy street 41. | krisztina.hracs@adwareresearch.com | +36205967957 | AdWare Research Ltd. | Inclusion criteria: <br>1) Age: 18 to 74 years (at the time of informed consent)<br>2) Gender: Male or female<br>3) Patients who meet all of the following criteria 1), 2), and 3) at the time of enrolment<br>o Patients with SARS-CoV-2-positive airway specimens such as nasopharyngeal swab, nasal aspirate, or airway aspirate by RT-PCR test<br>o Patients with new lung lesions on chest images<br>o Patients with a fever of 37.5°C or more<br>4) For premenopausal female patients, patients who have been confirmed to be negative on a pregnancy test before administration of the study drug<br>5) Patients who understand the contents of this study and are able to provide written consent by themselves without assistance, or as appropriate with their assent and consent of their parents<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 100<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 50<br> | Exclusion criteria: <br>1) Fever (37.5°C) more than 10 days after the onset of fever<br>2) Patients with SpO2 less than 95% without oxygen therapy <br>3) Patients who show increased procalcitonin levels before the start of study drug administration or are suspected to have concurrent bacterial infection<br>4) Patients with suspected concomitant fungal infections prior to initiation of study drug.<br>5) Patients with concurrent congestive heart failure (NYHA III-IV)<br>6) Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification<br>7) Patients with renal impairment requiring dialysis<br>8) Patients with disturbed consciousness such as disturbed orientation<br>9) Pregnant or possibly pregnant patients<br>10) Female patients who are woman of childbearing potential and unable to consent to the use of dual contraception from the start of favipiravir administration to 30 days after the end of favipiravir administration. Dual contraception is a combination of two of the following: Barrier method of contraception: condoms (male or female) with or without a spermicidal agent, diaphragm or cervical cap with spermicide; IUD; Hormone-based contraceptive; Tubal ligation.<br>11) Male patients who are unable to consent to the use of the barrier method of contraception (condom) the start of favipiravir administration to 90 days after the end of favipiravir administration. Male patients who are planning to donate sperm from the start up until 90 days after the end of favipiravir administration. <br>12) Female patients who intend to breastfeed from the start of favipiravir administration until 7 days after discontinuation of favipiravir administration <br>13) Patients with hereditary xanthinuria<br>14) Patients who have previously been diagnosed with hyperuricemia (> 1 mg/dL) or xanthine urinary calculi<br>15) Patients with a history of gout or on treatment for gout or hyperuricemia<br>16) Patients receiving immunosuppressants<br>17) Patients who have received interferon-alpha or drugs with reported antiviral activity against SARS-CoV-2 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, remdesivir, etc.) within 9 days after fever onset (37.5°C or more)<br>18) Patients in whom this episode of infection is a recurrence or a reinfection with the SARS-CoV-2 infection<br>19) Patients who have previously received favipiravir (T-705a)<br>20) Other patients judged ineligible by the investigator, sub-investigator, or assigned physician <br><br> | Patients with new type of coronavirus (SARS-CoV-2) infection proven by RT-PCR test with mild pneumonia. <br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: AVIGAN Tablets 200 mg<br>Product Name: AVIGAN<br>Pharmaceutical Form: Tablet<br><br> | Timepoint(s) of evaluation of this end point: Days 4,7,10,13,16,19,22,25,28. ;Primary end point(s): Time to improvement in body temperature, SpO2, chest imaging findings and negative SARS-CoV-2.;Secondary Objective: Not applicable;Main Objective: To verify that the efficacy of favipiravir exceeds that of the actual supportive care (symptomatic therapy) in SARS-CoV-2 infected patients (COVID-19 patients) with mild pneumonia, using the time required to improve clinical symptoms as the primary endpoint | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-001807-18-GB | 6 October 2020 | TD-0903 for acute lung injury associated with COVID-19 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, Multi-center Study of an Inhaled Pan-Janus Kinase Inhibitor, TD-0903, to Treat Symptomatic Acute Lung Injury Associated with COVID-19 - TD-0903 for acute lung injury associated with COVID-19 | | Theravance Biopharma Ireland Limited | 29/04/2020 | 20200429 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001807-18 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 18/05/2020 | 222 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: Placebo-controlled
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United Kingdom;Moldova, Republic of;South Africa;Romania;Ukraine;Brazil;Poland;Argentina;Finland;United States | Rajeev Saggar | | 901 Gateway Boulevard | rsaggar@theravance.com | 0019499221158 | Theravance Biopharma US, Inc. | Inclusion criteria: <br>1. Willing and able to provide written informed consent on their own prior to performing study procedures<br>In the U.K., subject assent, or proxy consent as per local site procedures, may also be acceptable if both a clinician and second health professional attest that the subject understands the risks and potential benefits of the study and elects to proceed.<br>Outside the U.K., written informed consent may only be obtained from the subject or legally authorized representative.<br>In the event the subject loses capacity during the study, the subject consents to continued participation, except where this is not clinically indicated.<br><br>2. Willing and able to comply with study-related procedures/assessments<br><br>3. Age 18 to 80 years old<br><br>4. Hospitalized (or documentation of a plan to admit to the hospital if the subject is in an emergency department) and requiring supplemental oxygen to maintain saturation > 90%<br><br>5. A diagnosis of symptomatic COVID-19 defined as a positive test for SARS-CoV-2 RNA detected by RT-PCR on a sample from the upper respiratory tract (e.g. nasopharyngeal, nasal, or oropharyngeal swab) collected < 72 hours prior to randomization<br><br>6. Onset of COVID-19-related symptoms > 2 days and = 14 days prior to hospital admission<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 150<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 72<br> | Exclusion criteria: <br>1. Subjects currently receiving invasive mechanical ventilation.<br><br>2. Presence or suspicion of active malignancy with the exception of cancer in situ (e.g., skin cancer)<br><br>3. Evidence of serious active infections other than COVID-19<br><br>4. Current diagnosis of human immunodeficiency virus, hepatitis B or C<br><br>5. In the opinion of the investigator, unlikely to survive for > 24 hours from enrollment<br><br>6. Women who are pregnant or might be pregnant, or who are currently breast-feeding<br>Subjects must agree to not donate ova or sperm through 30 days after the last dose of study medication.<br><br>7. Presence of significant comorbidity that, in the opinion of the investigator, predisposes the subject to mortality. Such conditions might include:<br>a. New York Heart Association class IV Heart Failure<br>b. Hepatic dysfunction (i.e., AST or ALT >3x upper limit of normal)<br>c. Renal dysfunction (i.e., estimated glomerular filtration rate (eGFR) <50 mL/min) or receiving renal replacement therapy<br><br>8. Presence of septic shock at time of enrollment<br><br>9. Hemoglobin < 80 g/L<br><br>10. Evidence of neutropenia (i.e., absolute neutrophil count < 1000 cells/µL), lymphopenia (i.e., absolute lymphocyte count < 200 cells/µL) or thrombocytopenia (i.e., platelets < 50×10^9/L)<br><br>11. Hypersensitivity to TD-0903 or its components, or to other JAK inhibitors<br><br>12. Treatment with anti-IL 6 (e.g., tocilizumab, sarilumab), anti-IL-1, anti-T cell (e.g., abatacept) antibodies, anti-IL-6R antagonists, JAK inhibitors (e.g., baricitinib, tofacitinib) supplemental interferon therapy, or tyrosine kinase inhibitors (e.g., erlotinib, gefinitib) in the past 30 days, or plans to receive a JAK inhibitor during the study periodTreatment with anti-IL 6, anti-IL-6R antagonists, or with JAK inhibitors in the past 30 days, or plans to receive a JAK inhibitor during the study period<br><br>13. Current treatment with conventional synthetic disease-modifying anti-rheumatic drugs (DMARDs)/immunosuppressive agents including:<br>a. Methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, or sulfasalazine within 2 weeks prior to enrollment<br>b. Azathioprine or cyclophosphamide within 12 weeks prior to enrollment<br>c. Monoclonal antibodies targeting B cells (eg rituximab) within 12 weeks prior to enrollment<br>d. Tumor Necrosis Factor-alpha (TNFa) inhibitors within 4 weeks prior to enrollment<br><br>14. Participating in other clinical trials involving any other experimental treatment for COVID-19, except in the context of a single-arm antiviral or convalescent plasma compassionate-use protocol<br><br>15. Subjects with active or incompletely treated pulmonary tuberculosis, or known history of non-tuberculosis mycobacterium over past 12 months<br><br>16. Subject requires continuous oxygen supplementation for underlying cardio-respiratory history in the past 90 days<br><br>17. Body Mass Index =40 kg/m2<br><br>18. Receipt of any live vaccine (i.e., live attenuated) in the 4 weeks prior to visit 1 or plans to receive a live vaccine (or live attenuated) during the study period.<br>Note: Use of non-live (inactivated) vaccinations is allowed for all subjects.<br><br>19. History of venous thromboembolism (VTE), deep venous thrombosis (DVT), Pulmonary Embolism (PE) or known hypercoagulable disorder (e.g. factor V Leiden, antiphospholipid antibody syndrome, protein C or S deficiency).<br> | Acute lung injury associated with COVID-19 <br>MedDRA version: 20.1
Level: HLT
Classification code 10047468
Term: Viral lower respiratory tract infections
System Organ Class: 100000004855
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: TD-0903<br>Pharmaceutical Form: Inhalation solution<br>INN or Proposed INN: TD-0903<br>Current Sponsor code: TD-0903<br>Other descriptive name: TD-0903<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: range<br>Concentration number: 0.5-10<br>Pharmaceutical form of the placebo: Inhalation solution<br>Route of administration of the placebo: Inhalation use<br><br> | Timepoint(s) of evaluation of this end point: Part 1:<br>Endpoints<br>Safety (Vital signs, clinical laboratory results, TEAEs): Day 1 through 7<br>PK: Day 1 pre-dose, 0.25, 0.5, 1, 2, 4, 6, 8, 12, 24 hours, Day 7<br>PD (SaO2/FiO2 ratio): Day 1 through 7<br><br>Additional Endpoints<br>Safety (Vital signs, clinical laboratory results, TEAEs): Day 1 through 28<br><br>Part 2<br>The primary endpoint is: <br>RFDs: up to Day 28;Primary end point(s): Part 1:<br>Endpoints (through Day 7)<br>Safety<br>• Change from baseline in vital signs and clinical laboratory results<br>• Incidence and severity of treatment-emergent AEs (TEAEs)<br>Pharmacokinetics<br>• Plasma PK parameters on Day 1 and Day 7<br>Pharmacodynamics (PD)<br>• Change from baseline in SaO2/FiO2 ratio<br><br>Additional Endpoints (through Day 28)<br>Safety<br>• Change from baseline in vital signs, and clinical laboratory results<br>• Incidence and severity of TEAEs<br><br>Part 2<br>The primary endpoint is the number of RFDs from randomization through Day 28;Secondary Objective: The secondary objectives are to evaluate the effect of TD-0903 on:<br>• Reducing the acute lung injury (as measured by SaO2/FiO2 ratio) associated with COVID-19<br>• Safety and tolerability<br>• Clinical outcomes as measured by an 8-point clinical status scale<br>• The proportion of subjects alive and respiratory failure-free on Day 28;Main Objective: Part 1<br>The objectives are:<br>• Evaluate the safety and tolerability of inhaled TD-0903 in subjects with COVID-19<br>• Assess the plasma pharmacokinetics (PK) of TD-0903 in subjects with COVID-19<br>• Characterize the effect of TD-0903 on reducing the acute lung injury (as measured by SaO2/FiO2 ratio) associated with COVID-19<br>• Explore the effect of TD-0903 on swab viral infection status, SARS-CoV-2 antibody levels, blood cytokine levels, and biomarkers of inflammation, thrombosis and lung injury <br><br>Part 2<br>The primary objective is to characterize the efficacy of TD-0903 as measured by respiratory failure-free days (RFDs) through Day 28.<br> | | | | Yes | True | parent | |
| → | EUCTR2020-002110-41-GB | 6 October 2020 | A clinical study in a community setting to see whether use of camostat reduces the worsening of COVID-19. | SPIKE-1 TRIAL: A Randomised Phase II/III trial in a community setting, assessing use of camostat in reducing the clinical progression of COVID-19 by blocking SARS-CoV-2 Spike protein-initiated membrane fusion. - SPIKE-1 | | Cancer Research UK | 29/05/2020 | 20200529 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002110-41 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 18/06/2020 | 389 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: standard of care control arm
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| United Kingdom | Centre for Drug Development | | 2 Redman Place | regulatory@cancer.org.uk | +440207242 0200 | Cancer Research UK | Inclusion criteria: <br>1.Patient willing and able to give informed consent <br>2.Adults, 18 years of age and above who score moderate to very high risk according to COVID-age risk calculation (Appendix 4) <br>3.Typical symptoms of COVID-19 infection e.g.as per Public Health England guidance or equivalent organisations in the UK, Health Protection Scotland, Public Health Wales, Public Health Agency (Northern Ireland)<br>4.Plus evidence of current COVID-19 infection from a validated assay<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 273<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 116<br> | Exclusion criteria: <br>1.Significant electrolyte disturbance (e.g. hyperkalaemia, potassium >5.0 mmol/L).<br>2.Any condition that, in the Investigator's opinion, will prevent adequate compliance with trial therapy e.g. mild cognitive impairment (unable to follow instructions for self assessment readings as assessed by the Investigator).<br>3.Patients on long term supplementary oxygen requirement (patients for whom hospital admission would not be considered e.g. care plan in the community is in place, are not excluded) <br>4.Known hypersensitivity to camostat <br>5.Platelet count <100 x 10^9/L <br>6.Co-enrolment with a Clinical Trial of an Investigational Medicinal Product (CTIMP) will not be permitted. Co-enrolment with a clinical investigation of a Medical Device or a non-interventional clinical study will be considered on a study-by-study basis and in discussion with the relevant Chief Investigators and Sponsors and industrial collaborators. <br>7.Co-enrolment involving non-interventional research (including questionnaire or tissue only studies) will be allowed provided this is not expected to affect the outcomes of both studies or place undue burden upon participants and their families. <br>8.Female patients who are able to become pregnant (or are already pregnant or lactating). However, those patients who are of child bearing potential and have a negative serum or urine pregnancy test before enrolment and agree to use two forms of contraception (one effective form plus a barrier method) [oral, injected or implanted hormonal contraception and condom; intra-uterine device and condom; diaphragm with spermicidal gel and condom] or agree to sexual abstinence*, effective from the first administration of camostat, throughout the trial and for 28 days afterwards are considered eligible (*Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.)<br>9.Male patients with partners of child-bearing potential (unless they agree to take measures not to father children by using a barrier method of contraception [condom plus spermicide] or to sexual abstinence* effective from the first administration of camostat, throughout the trial and for 28 days afterwards. Men with partners of child-bearing potential must also be willing to ensure that their partner uses an effective method of contraception for the same duration for example, hormonal contraception, intrauterine device, diaphragm with spermicidal gel or sexual abstinence). Men with pregnant or lactating partners must be advised to use barrier method contraception (for example, condom plus spermicidal gel) to prevent exposure of the foetus or neonate.<br>(*Abstinence is only considered to be an acceptable method of contraception when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.) <br>10.Significant cardiovascular disease (as assessed via the particpant’s medical record and history) as defined by: <br>a. History of congestive heart failure requiring therapy (New York Heart Association (NYHA) III or IV) <br>b. History of unstable angina pectoris or myocardial infarction up to 6 months prior to trial entry <br>c. Presence of severe valvular heart disea | COVID-19 <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: FOIPAN ®<br>Product Name: Camostat mesilate<br>Product Code: Camostat<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: CAMOSTAT MESILATE<br>CAS Number: 59721-29-8<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br> | Timepoint(s) of evaluation of this end point: Days 1-28;Primary end point(s): Hospital admission requiring supplemental oxygen;Secondary Objective: 1. To assess the ability of camostat to reduce the requirement for COVID-19 related hospital admission in patients with SARS-CoV-2 infection.<br>2. To evaluate the requirement for supplementary oxygen (non-invasive or mechanical invasive) in patients who have received camostat as treatment for SARS-CoV-2 infection.<br>3. To evaluate the requirement for ventilation in patients who have received camostat as treatment for SARS-CoV-2 infection. <br>4. To evaluate overall mortality.<br>5. To evaluate efficacy of camostat by effect on clinical improvement.;Main Objective: To evaluate the efficacy of camostat to prevent respiratory deterioration in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.→Main Objective: To evaluate the efficacy of camostat to prevent respiratory deterioration in patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection.;Secondary Objective: 1. To assess the ability of camostat to reduce the requirement for COVID-19 related hospital admission in patients with SARS-CoV-2 infection.<br>2. To evaluate the requirement for supplementary oxygen (non-invasive or mechanical invasive) in patients who have received camostat as treatment for SARS-CoV-2 infection.<br>3. To evaluate the requirement for ventilation in patients who have received camostat as treatment for SARS-CoV-2 infection. <br>4. To evaluate overall mortality.<br>5. To evaluate efficacy of camostat by effect on clinical improvement.;Primary end point(s): Hospital admission requiring supplemental oxygen;Timepoint(s) of evaluation of this end point: Days 1-28 | | | | Yes | False | | |
| IRCT20170117032004N3 | 6 October 2020 | Effect of vitamin A in patients with COVID19 | evaluation the effect of vitamin A on respiratory signs and hospitalization in patients with COVID-19 | | Tabriz University of Medical Sciences | 2020-03-29 | 20200329 | IRCT | http://en.irct.ir/trial/46564 | Not Recruiting | No | 18 years | no limit | Both | 2020-04-03 | 30 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: simple random allocation using computer by a person who is not one of researcher of the study and based on the numbers allocated to each patients. | N/A | Iran (Islamic Republic of) | Zeinab Nikniaz | | Liver and gastrointestinal diseases research center, Imam Reza Hospital, Tabriz University of medical sciences, Daneshgah street | znikniaz@hotmail.com | +98 41 3335 1688 | Tabriz University of Medical Sciences | Inclusion criteria: confirmed diagnosis of COVID19 with RT-PCR<br>hospitalized patients<br>ventilator independent patients | Exclusion criteria: being pregnant,<br>lactating mothers,<br>not consent to participate in the study<br>using high-dose vitamin A in last month | U07.1. <br>Confirmed cases;07.1 | Intervention 1: Intervention group: 50000 Vitamin A daily for two weeks. Intervention 2: Control group: common treatment. | Clinical response. Timepoint: until discharge from hospital. Method of measurement: Questionnaire. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| IRCT20151228025732N51 | 6 October 2020 | Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris supplements on the Severity and Consequences of Coronavirus 19 disease (COVID-19) | Effect of Algomed, Menta longifolia, Chamomile, Althaea rosea, Malva sylvestris supplements on the Severity and Consequences of COVID-19 | | Semnan University of Medical Sciences | 2020-04-08 | 20200408 | IRCT | http://en.irct.ir/trial/46828 | Not Recruiting | No | no limit | no limit | Both | 2020-03-18 | 60 | interventional | Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. | N/A | Iran (Islamic Republic of) | Rahimeh Eskandarian | | Street Amin, Semnan | are20935@gmail.com | +98 23 3345 1336 | Semnan University of Medical Sciences | Inclusion criteria: COVID-19 Patients Admitted to Kowsar Hospital Respiratory Ward | Exclusion criteria: Malignant diseases (Cancers)<br>Severe renal, liver and heart failure<br>Taking anticoagulants especially warfarin<br>Pregnancy<br>Lactating mothers | Coronavirus. <br>Coronavirus infection, unspecified;B34.2 | Intervention 1: Intervention group: In addition to the treatment protocol, patients are given four daily doses of 300 mg of Vulgaris.C supplemented with Herbal tea (2g Pennyroyal; 2g chamomile, 1.4g Hollyhocks and 0.6g Mallow). Intervention 2: Control group: Treatment is according to the protocol and is for comparison only with the intervention group. | Clinical symptoms (Coronavirus infection). Timepoint: Before starting the study and daily until discharge. Method of measurement: Laboratory values and radiographic changes or CT scans. | | | | No | False | | |
| → | IRCT20190717044241N2 | 6 October 2020 | Cell therapy in patients with COVID-19 | Cell therapy in patients with COVID-19 using mesenchymal stem cells | | Barakat Pharmaceutical Group | 2020-04-22 | 20200422 | IRCT | http://en.irct.ir/trial/47110 | Recruiting | No | 17 years | 65 years | Both | 2020-04-20 | 5 | interventional | Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. | 1 | Iran (Islamic Republic of) | Mahshid Saleh - Dr Iman seyhoun | | No. 88, Italy St, Eastern side of Tehran University? Tehran, Tehran Province | Mahshid_saleh@ymail.com | +98 21 4305 2000 | Tehran University of Medical Sciences | Inclusion criteria: Persistent hypoxemia despite receiving less than 93% Saturation oxygen<br>Respiratory failure requires a Ventilator<br>Chest has multilobar infiltrates<br>Shock<br>Organ failure | Exclusion criteria: Patient dissatisfaction<br>Pregnant patient<br>Age less than 17 years<br>Patient with known active malignancy | COVID-19. <br>COVID-19, virus identified;U07.1 | Intervention group: Patients with COVID-19 who are transplanted with mesenchymal stem cells that are injected 2x 106 (based on IBW) Via (IV) intravenous injection.. | Clinical response. Timepoint: 28 days-From the time of cell injection until the 28th day. Method of measurement: clinical observation by Infectious Diseases Specialist.;O2 saturation. Timepoint: 0,3,6days.Since the injection of the cell. Method of measurement: ventilator.;Inflammation cytokines. Il-6 & Il-10. Timepoint: 0,3,6,14 days-Since the injection of the cell. Method of measurement: Assay by the Elisa.→Inflammation cytokines. Il-6 & Il-10. Timepoint: 0,3,6,14 days-Since the injection of the cell. Method of measurement: Assay by the Elisa.;O2 saturation. Timepoint: 0,3,6days.Since the injection of the cell. Method of measurement: ventilator.;Clinical response. Timepoint: 28 days-From the time of cell injection until the 28th day. Method of measurement: clinical observation by Infectious Diseases Specialist. | | | | No | False | | |
| IRCT20081019001369N7 | 6 October 2020 | Clinical trial of trans sodium crocetinate against COVID-19 | Evaluation of trans sodium crocetinate spray against on mild to moderate ARDS induced by COVID-19 patients: A Randomized Open label Clinical Trial | | Mashhad University of Medical Sciences | 2020-09-27 | 20200927 | IRCT | http://en.irct.ir/trial/47441 | Not Recruiting | No | 18 years | 75 years | Both | 2020-10-22 | 30 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization in three stages: 1- Random sequence
generation: this step simple or limited randomization will
be done based on a table of random numbers 2-
Allocation concealment: which is done in the form of
coded boxes (numbered drug containers) with a random
sequence. In this method, a number of boxes with the
same shape and size are numbered based on random
sequences and contain drugs or placebo that have a
completely similar appearance. 3- Execution of random
allocation process: A: Identify the person who creates the
random sequence B: A person who evaluates and
registers researchers in terms of inclusion and exclusion
criteria C: The person who assigned the participants to
the groups: infectious diseases specialist The main
researcher of the project, who creates a random
sequence, does not interfere in other stages of
randomization, includi | 2 | Iran (Islamic Republic of) | Hossein Hosseinzadeh | | Blv. Vakilabad2-School of Pharmacy, 1365-91775 | hosseinzadehh@mums.ac.ir | +98 51 3180 1193 | Mashhad University of Medical Sciences | Inclusion criteria: Patients with clinical diagnosis for COVID-19 disease<br>Patients with acute respiratory distress syndrome (ARDS)<br>PF ratio (the ratio of arterial oxygen partial pressure to fractional inspired oxygen) <200<br>Patients not having kidney, liver and heart dysfunction according to clinical and laboratory findings | Exclusion criteria: Allergic reactions to saffron<br>Pregnancy and breast-feeding,<br>Multi organ dysfunction disease | COVID-19. <br>COVID-19 Disease;U07.1 | Intervention 1: Intervention group: In addition to the standard treatment regimen for COVID-19, the trans sodium crocetinate spray with a nebulizer as an oral spray twice a day will be given for 1 week. Intervention 2: Control group: Patients will received the standard treatment regimen for COVID-19 for 7 days. | Frequency of patients mortality. Timepoint: during 7 days hospitalization. Method of measurement: counting the number. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-001610-38-DK | 13 October 2020 | Irbesartan and Oseltamivir treatment of COVID-19 infection. | Irbesartan and Oseltamivir treatment of COVID-19 infection. - Covid-19 protection trial | | Slagelse Sygehus | 07/04/2020 | 20200407 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001610-38 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 16/09/2020 | 80 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Denmark | | | | | | | Inclusion criteria: <br>Patients age 50-89 years and Covid-19 positiv and home.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 40<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 40<br> | Exclusion criteria: <br>Actual treatment with ACE-inhibitor, AT-II receptor antagonist or diuretics<br>Blood pressure below 110/60<br>Pregnancy<br>Allergy to Irbesartan or Oseltamivir<br> | The combined treatment in this trial will be used to treat patients with Covid-19 infection in order to prevent the patients need for further treatment in a hospital. <br>MedDRA version: 23.0
Level: LLT
Classification code 10084382
Term: Coronavirus disease 2019
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Aprovel<br>Pharmaceutical Form: Tablet<br>Other descriptive name: IRBESARTAN<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 300-<br>Pharmaceutical form of the placebo: Capsule<br>Route of administration of the placebo: Oral use<br><br>Trade Name: Tamiflu<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: OSELTAMIVIR<br>CAS Number: 196618-13-0<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 75-<br>Pharmaceutical form of the placebo: Capsule<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: 14 days;Primary end point(s): Preventing patients with Covid-19 infection treated at home in hospitalizing for this diseace.;Secondary Objective: If the patients should need hospital treatment, the secondary objective is to prevent progression of the infection causing need for invasive treatment.;Main Objective: To prevent progression of Covid-19 infections in Covid possitive patient not yet admitted to hospital. The objective is, that the active treated patient will not need further treatment during stay in a hospital. | | | | Yes | False | | |
| → | EUCTR2020-001498-63-GB | 13 October 2020 | Testing the Efficacy and Safety of BIO101, for the Prevention of Respiratory Deterioration, in Patients with COVID-19 Pneumonia (COVA study) | Adaptive design phase 2 to 3, randomized, double- blind, multicenter, to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BIO101 in the prevention of the respiratory deterioration in hospitalized patients with COVID-19 pneumonia (severe stage) | | Biophytis S.A. | 09/06/2020 | 20200609 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001498-63 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 01/10/2020 | 465 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>Other trial design description: placebo-controlled, group sequential and adaptive<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United Kingdom;Belgium;Brazil;France;United States | Mounia Chabane De Saint Aubin | | 14 Avenue de l' Opéra | mounia.chabane@biophytis.com | +33(0)144 27 23 87 | Biophytis S.A. | Inclusion criteria: <br>1. Age: 55 and older.
<br>2. A confirmed diagnosis of COVID-19 infection, within the last 14 days, prior to randomization, as determined by PCR or other approved commercial or public health assay, in a specimen as specified by the test used.
<br>3. Hospitalized, in observation or planned to be hospitalized due to COVID-19 infection symptoms with anticipated hospitalization duration >=3 days
<br>4. With evidence of pneumonia based on all of the following:
<br>a. Clinical findings on a physical examination
<br>b. Respiratory symptoms developed within the past 7 days
<br>5. With evidence of respiratory decompensation that started not more than 4 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff:
<br>a. Tachypnea: =25 breaths per minute
<br>b. Arterial oxygen saturation =92%, on Oxygen at at least 3L/min
<br>c. A special note should be made if there is suspicion of COVID-19-related myocarditis or pericarditis, as the presence of these is a stratification criterion
<br>6. Without a significant deterioration in liver function tests:
<br>a. ALT and AST = 5x upper limit of normal (ULN)
<br>b. Gamma-glutamyl transferase (GGT) = 5x ULN
<br>c. Total bilirubin = 5×ULN
<br>7. Willing to participate and able to sign an informed consent form (ICF)
<br>8. Female participants should be:
<br>at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile
<br>OR
<br>a. Have a negative urine pregnancy test at screening
<br>b. Be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose.
<br>9. Male participants who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product;
<br>Note: medically acceptable methods of contraception that may be used by the participant and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy.
<br>10. Male subjects must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product;
<br>11. For France only: Being affiliated with a European Social Security.
<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 100<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 100<br> | Exclusion criteria: <br>1. Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication)
<br>2. Moribund condition (death likely in days) or not expected to survive for >7 days – due to other and non-COVID-19 related conditions
<br>3. Participant on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO), or high-flow Oxygen*
<br>4. Participant within 7 days of participating in other therapeutic clinical trial with angiotensin-converting-enzyme inhibitors (ACEi), angiotensin-receptor blockers (ARB) or recombinant ACE-2
<br>5. Participant not able to take medications by mouth (as capsules or as a powder, mixed in water).
<br>6. Disallowed concomitant medication:
<br>a. Consumption of any herbal products containing 20 hydroxyecdysone and derived from Leuzea carthamoides; Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents)
<br>7. For participants receiving RAS pathway modulators (e.g., ACEi, ARB, or renin or aldosterone inhibitors): not on a stable regimen for at least 4 weeks prior to screening or regimen not expected to remain stable for the duration of the study.
<br>8. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101
<br>9. Renal disease requiring dialysis, or known renal insufficiency (eGFR=30 mL/min/1.73 m2, based on Cockroft & Gault formula)
<br>10. In France:
<br>o Non-affiliation to compulsory French social security scheme (beneficiary or right-holder)
<br>o Being under tutelage or legal guardianship
<br>* High-flow oxygen is defined as delivery of oxygen at a flow of =16 L/min.<br> | Confirmed infection with SARS-CoV-2 (COVID-19) <br>MedDRA version: 20.0
Level: HLT
Classification code 10047465
Term: Viral infections NEC
System Organ Class: 10021881 - Infections and infestations
<br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: BIO101<br>Product Code: BIO101<br>Pharmaceutical Form: Capsule<br>INN or Proposed INN: NA<br>CAS Number: 5289-74-7<br>Current Sponsor code: BIO101<br>Other descriptive name: 20-hydroxyecdysone<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 175-<br>Pharmaceutical form of the placebo: Capsule<br>Route of administration of the placebo: Oral use<br><br> | Primary end point(s): For end-of-part-1 interim analysis:<br><br>For safety analysis intended to facilitate the decision to begin part 2, time frame – up to 28 days:<br><br>Safety and tolerability to BIO101:<br><br>• SUSARs, SAEs, AESIs, AEs<br>• Vital signs<br>• Safety labs (including testicular biomarkers)<br>• ECGs<br><br>For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:<br><br>Primary:<br><br>• Proportion of subjects with ‘negative’ events, of either of the following: <br>o All-cause mortality<br>o Respiratory failure, defined as any of the following:<br>- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)<br>- Requiring ECMO<br>- Requiring high-flow oxygen <br><br>Secondary:<br>• SpO2/FiO2<br>• Inflammatory markers including:<br>o IL 6<br>o TNFa <br>o D-dimer <br>• RAS / MAS biomarkers:<br>o Angiotensin 2<br>o Angiotensin-converting enzyme (ACE) levels<br><br>For part-2 sample size interim analysis:<br><br>For sample size re-assessment for part 2, time frame – up to 28 days:<br>• Proportion of participants with ‘negative’ events, of either of the following:<br>o All-cause mortality<br>o Respiratory failure, defined as any of the following: <br>- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)<br>- Requiring ECMO<br>- Requiring high-flow oxygen<br><br>For the final analysis:<br><br>Primary, time frame – up to 28 days: <br><br>• Proportion of participants with ‘negative’ events, of either of the following:<br>o All-cause mortality <br>o Respiratory failure, defined as any of the following: <br>- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)<br>- Requiring ECMO<br>- Requiring high-flow oxygen<br>;Timepoint(s) of evaluation of this end point: For end-of-part-1 interim analysis:<br>For safety analysis intended to facilitate the decision to begin part 2, time frame – up to 28 days:<br><br>For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:<br><br>For part-2 sample size interim analysis:<br>For sample size re-assessment for part 2, time frame – up to 28 days:<br><br>For the final analysis:<br>Primary, time frame – up to 28 days: <br>;Secondary Objective: Not applicable;Main Objective: Part 1<br>• Obtain preliminary indication of activity of BIO101, in preventing respiratory deterioration in the target population<br><br>Part 2<br>• Re-assess the sample size that is needed for the confirmatory part of the study<br>• Provide confirmation on the benefit of BIO101 in the target population<br>• Identify and assess potential biomarkers for further understanding of the effect of BIO101 in the target population<br>→Secondary Objective: Not applicable;Main Objective: Part 1<br>• Obtain preliminary indication of activity of BIO101, in preventing respiratory deterioration in the target population<br><br>Part 2<br>• Re-assess the sample size that is needed for the confirmatory part of the study<br>• Provide confirmation on the benefit of BIO101 in the target population<br>• Identify and assess potential biomarkers for further understanding of the effect of BIO101 in the target population<br>;Timepoint(s) of evaluation of this end point: For end-of-part-1 interim analysis:<br>For safety analysis intended to facilitate the decision to begin part 2, time frame – up to 28 days:<br><br>For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:<br><br>For part-2 sample size interim analysis:<br>For sample size re-assessment for part 2, time frame – up to 28 days:<br><br>For the final analysis:<br>Primary, time frame – up to 28 days: <br>;Primary end point(s): For end-of-part-1 interim analysis:<br><br>For safety analysis intended to facilitate the decision to begin part 2, time frame – up to 28 days:<br><br>Safety and tolerability to BIO101:<br><br>• SUSARs, SAEs, AESIs, AEs<br>• Vital signs<br>• Safety labs (including testicular biomarkers)<br>• ECGs<br><br>For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:<br><br>Primary:<br><br>• Proportion of subjects with ‘negative’ events, of either of the following: <br>o All-cause mortality<br>o Respiratory failure, defined as any of the following:<br>- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)<br>- Requiring ECMO<br>- Requiring high-flow oxygen <br><br>Secondary:<br>• SpO2/FiO2<br>• Inflammatory markers including:<br>o IL 6<br>o TNFa <br>o D-dimer <br>• RAS / MAS biomarkers:<br>o Angiotensin 2<br>o Angiotensin-converting enzyme (ACE) levels<br><br>For part-2 sample size interim analysis:<br><br>For sample size re-assessment for part 2, time frame – up to 28 days:<br>• Proportion of participants with ‘negative’ events, of either of the following:<br>o All-cause mortality<br>o Respiratory failure, defined as any of the following: <br>- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)<br>- Requiring ECMO<br>- Requiring high-flow oxygen<br><br>For the final analysis:<br><br>Primary, time frame – up to 28 days: <br><br>• Proportion of participants with ‘negative’ events, of either of the following:<br>o All-cause mortality <br>o Respiratory failure, defined as any of the following: <br>- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)<br>- Requiring ECMO<br>- Requiring high-flow oxygen<br> | | | | Yes | False | | |
| ISRCTN18428598 | 19 October 2020 | Does the Flexible Phonics programme lead to improved reading outcomes for children in Reception when taught in addition to existing phonics programmes/practice? | A randomised controlled trial to investigate whether the Flexible Phonics programme, which introduces direct mapping and set-for-variability strategies, lead to improved reading outcomes for children in Reception in England when taught in addition to existing phonics programmes/practice? | | Education Endowment Foundation | 08/10/2020 | 20201008 | ISRCTN | http://isrctn.com/ISRCTN18428598 | Recruiting | No | | | Both | 01/01/2020 | 2875 | Interventional | Two-arm multi-centre cluster randomized controlled efficacy trial with pupil-level outcomes (Other) | Not Applicable | United Kingdom | Anneka | Dawson |
Institute for Employment Studies
City Gate
185 Dyke Road
| anneka.dawson@ies.ac.uk | +44 (0)1273 763 445 | | Inclusion criteria: Children attending Reception class during the academic year 2020/2021 at participating schools in the Greater London area, England, UK | Exclusion criteria: <br> 1. Where a child does not participate in Reception year phonics teaching<br> 2. Where teaching staff or parents/guardians believe that a child's participation in the assessment will cause unnecessary distress or unsuitable data, e.g. where a child is diagnosed with a learning difficulty which means that the tasks in the assessment are unsuitable for their current level of learning<br> 3. Where a parent has requested to withdraw their child's data from the trial. The child will still receive the same intervention/control phonics teaching as those participating in the study but their data will not be collected through assessment or will be excluded where an assessment has already taken place<br> | Early years literacy, with a focus on exception words <br>Not Applicable | <br> Eligible schools are state-funded schools based in the Greater London area, England, UK. Those schools with larger numbers of free school meals pupils will be prioritised in recruitment. All teachers and teaching assistants (TAs) will be invited to attend the Flexible Phonics training and all children in Reception will be taught using Flexible Phonics. However, only one Reception class in each school will be included in the trial and its pupils will participate in literacy assessments at pre- and post-intervention.<br><br> Flexible Phonics is a programme for teaching phonics, which incorporates direct mapping and the teaching of set-for-variability strategies, with a particular focus on exception words and independent learning.<br><br> Randomization takes place at the class level and school level. Where schools have multiple Reception classes, the first stage of randomization involves selecting which Reception class will participate in the trial. The second stage of randomization involves randomly assigning classes (and thus schools) to the treatment/intervention arm or to the control arm.<br><br> In the intervention group, Reception teachers and teaching assistants will receive two half days of initial training, a further half-day of follow up training, two supportive school visits (or online/phone consultation if COVID-19 restrictions are in place) and ongoing online/telephone support. Training will enable teachers and teaching assistants to deliver the strategies to a whole-class of pupils as well as a smaller intervention group.<br><br> In the control group, Reception teachers and teaching assistants will continue with their usual phonics teaching approach. After the intervention and assessments have been complet | Word reading measured by the York Assessment for Reading Comprehension Test: early word recognition subscales at baseline and 8 months | | 31/01/2023 | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-004928-42-HU | 19 October 2020 | Clinical trail of remdesivir in Covid-19 patinets | Open-label study to assess the safety of REMdesivir-HU as Eligible Novel therapY for moderate and severe Covid-19 patients | | Hungarian Ministry of Innovation and Technology - Representative: Hecrin Consortium | 12/10/2020 | 20201012 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004928-42 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 12/10/2020 | 2000 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Hungary | CRO | | Völgy street 41. | krisztina.hracs@adwareresearch.com | | AdWare Research Ltd. | Inclusion criteria: <br>o Males or females aged 12yrs and older with body weight at least 40kg<br>o Hospitalized with COVID-19 confirmed by PCR and/or COVID-19 typical symptoms with pneumonia:<br>? In case of no confirmed PCR test result available at screening, typical symptoms can also apply <br>o requiring supplemental oxygen at screening<br>? at the discretion of the investigator, any form of O2 support can apply<br>o Do not have access to Veklury treatment<br>? Patient may be under other treatment against COVID-19 (except for chloroquine/hydroxychloroquine) <br>o Willing and able to provide valid written informed consent prior to performing study procedures (for those <18yrs of age, parental consent and patient assent is required)<br><br><br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 1600<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 360<br> | Exclusion criteria: <br>Patients meeting any of the below criteria are not eligible<br>o Known liver disease, hepatic impairment and/or Alanine Transaminase (ALT) or Aspartate Transaminase (AST) = 5 times the upper limit of normal<br>o Known severe renal disease (including patients receiving hemodialysis or hemofiltration) and/or estimated glomerular filtration rate (eGFR) < 30 ml/min.<br>o Pregnancy or breast feeding at the discretion of the investigator<br>o Anticipated discharge from the hospital or transfer to another hospital which is not a study site within 120 hours<br>o Other investigationsl treatment up to 2x the “emptying” time of treatment, or if this is not known for 60 days, except in the case of a favipiravir study. In case of the clinical trial of favipiravir the petinents can be enrolled in the study if afterthe end of study / early termination visit. <br>o Know allergy to any anti-viral medication<br>? Hypersensitivity to the active substance(s) or to any of the excipients<br>o Current (or 48 hours prior) treatment with chloroquine/hydroxychloroquine<br>o Any medical condition that the examining physician deems unsuitable for the patient to participate in the study.<br><br> | SARS-CoV-2 Infection <br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Remdesivir-HU 100 mg concentrate for solution for infusion <br>Pharmaceutical Form: Infusion<br><br> | Timepoint(s) of evaluation of this end point: 10 months;Primary end point(s): <PRIM> The primary endpoint of the study is the proportion of patients with at least 1treatment-emergent AESI (death, hypersensitivity including infusion-related reaction, anaphylactic reaction, acute respiratory failure, hypotension, hepatic toxicity and nephrotoxicity). <br>Secondary endpoints:<br>The secondary safety endpoints of the study are:<br><SEC1> the proportion of patients with at least 1 treatment-emergent adverse event<br><SEC2> proportion of patients with treatment-emergent clinical laboratory abnormalities (separately for the following parameters: ALT, AST, INR, HGB, Bilirubin, ALP, Creatinine, eGFR)<br>;Secondary Objective: To evaluate the efficacy of REM in COVID-19 patients Hungary;Main Objective: To assess the safety and tolerability of REM use in Hungary in the conditionally approved indication (EMA). | | | | Yes | False | | |
| → | EUCTR2020-001473-79-GB | 19 October 2020 | Dapagliflozin in Respiratory failure in patients with COVID-19 | An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Dapagliflozin in Respiratory Failure in Patients with COVID-19 - Dapagliflozin in Respiratory failure in patients with COVID-19 | | Saint Luke’s Hospital of Kansas City, Kansas City, Missouri, USA | 24/04/2020 | 20200424 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001473-79 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 07/05/2020 | 900 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| United States;Spain;Italy;United Kingdom→United Kingdom;Italy;Spain;United States | Andrejs Faibusevics | | 9 Dallington St. | afaibusevics@georgeclinical.com | +37129235028 | George Clinical (UK) Limited | Inclusion criteria: <br>For inclusion in the study patients should fulfil the following criteria based on local regulations:<br>1 Provision of informed consent prior to any study specific procedures. The ICF process is described in Section 10.4<br>2 Male or female patients aged =18 years on the day consent given<br>3 Currently hospitalized<br>4 Confirmed SARS-CoV-2 infection by laboratory testing <72h prior to randomization or strongly suspected on presentation<br>5 Chest radiography or CT findings consistent with COVID-19, defined as: chest X-ray and/or CT scan demonstrating ground glass and/or fine reticular opacities with or without crazy-paving, multifocal organizing pneumonia and architectural distortion in a predominantly peripheral distribution<br>6 Mild-moderate disease: SpO2=94% with low-flow supplemental oxygen (3 liters or less)<br>7 Medical history of at least one of the following: <br>(a) hypertension<br>(b) T2DM<br>(c) atherosclerotic cardiovascular disease<br>(d) heart failure (with either reduced or preserved LVEF)<br>(e) CKD stage 3 to 4 (eGFR between 25 to 60 mL/min/1.73 m2)<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 450<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 450<br> | Exclusion criteria: <br>1 Severe COVID-19: requiring mechanical ventilation via endotracheal intubation, and/or non-invasive ventilation<br>2 Expected need for mechanical ventilation with endotracheal intubation, non-invasive ventilation, or continuous positive airway pressure (CPAP) within the next 24 hours<br>3 Anticipated transfer to another hospital facility, which is not another study site, within 72 hours<br>4 Expected survival of less than 24 hours at the time of presentation, in the judgement of the Investigator<br>5 eGFR <25 mL/min/1.73 m2 or receiving renal replacement therapy/dialysis<br>6 Evidence of oliguria (urine output <500 mL in 24 hours or <0.5 mL/kg/hour) or serum creatinine =1.5x baseline pre-hospitalization value, if available at the time of screening <br>7 Systolic BP <95 mmHg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support at Screening<br>8 History of type 1 diabetes mellitus<br>9 Currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies for COVID-19**<br>10 History of diabetic ketoacidosis within last 6 months<br>11 Current treatment with any SGLT2i (eg, dapagliflozin, canagliflozin, empagliflozin, ertugliflozin) or having received treatment with any SGLT2i within 4 weeks prior to screening <br>12 History of hypersensitivity to dapagliflozin<br>13 Any other condition that in the judgment of the investigator would jeopardize the patient's participation in the study or that may interfere with the interpretation of study data or if the patient is considered unlikely to comply with study procedures, restrictions and requirements<br>14 Women of childbearing potential: Current or planned pregnancy or currently lactating. <br>(a) Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or post-menopausal<br>(b) Post-menopausal is defined as 12 consecutive months with no menses without an alternative medical cause<br>(c) Women of childbearing potential, who are sexually active, must agree to use a medically accepted method of birth control for the duration of the study. <br>15 Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site)<br>16 Previous enrolment in the present study. (Note: the study design allows 2 attempts to meet the randomization criteria after enrolment.)<br>17 Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry<br> | Respiratory Failure in patients with COVID-19;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Dapagliflozin<br>Product Code: A10BK01<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: Dapagliflozin<br>CAS Number: 461432-26-8<br>Current Sponsor code: BMS-512148-05<br>Other descriptive name: DAPAGLIFLOZIN<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 10-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br> | Main Objective: To determine whether dapagliflozin 10 mg is superior to placebo, in reducing disease progression, complications, and all-cause mortality in patients hospitalized with COVID-19.;Secondary Objective: To evaluate the net clinical benefit of dapagliflozin 10 mg compared to placebo in patients hospitalized with COVID 19<br>To compare the effect of dapagliflozin 10 mg versus placebo on time to hospital discharge<br>To compare the effect of dapagliflozin 10 mg versus placebo on total number of days alive, out of hospital, and/or free from mechanical ventilation<br>To compare the effect of dapagliflozin 10 mg versus placebo on total number of days alive, not in ICU, and/or free from mechanical ventilation<br>To compare the effect of dapagliflozin 10 mg versus placebo in reducing the incidence of all cause mortality<br>To compare the effect of dapagliflozin 10 mg versus placebo in reducing new or worsened organ dysfunction<br>To compare the effect of dapagliflozin 10 mg versus placebo on acute kidney injury ;Timepoint(s) of evaluation of this end point: A number of efficacy endpoints, listed below, relate to the timing of an event. Patients are reviewed daily for the occurrence of each of these events. The date and time (24 hr) (time if known) of the event will be recorded.<br>• Death from any cause<br>• New/worsened organ dysfunction (as defined in the primary outcome measure). This will be tested for both definitions of respiratory decompensation<br>• Hospital discharge<br>• Acute kidney injury (defined as doubling of s Creatinine compared to baseline)<br>The NEWS 2 can be used on all hospitalized patients to allow for the early detection of clinical deterioration and potential need for higher level of care. It determines the degree of illness of a patient and prompts critical care intervention. ;Primary end point(s): Time to first occurrence of either death from any cause or new/worsened organ dysfunction through 30 days of follow up, defined as at least one of the following: <br>• Respiratory decompensation requiring initiation of invasive or non invasive mechanical ventilation or continuous positive airway pressure (CPAP) treatment, and/or initiation of veno venous extracorporeal membrane oxygenation (ECMO)<br>• New or worsening congestive HFa during current hospitalization<br>• Requirement for vasopressor therapy and/or inotropic or mechanical circulatory support<br>• Ventricular tachycardia or fibrillation lasting at least 30 seconds and/or associated with hemodynamic instability or pulseless electrical activity, or resuscitated cardiac arrest<br>• Initiation of renal replacement therapy | | | | Yes | False | | |
| EUCTR2020-002211-21-GB | 19 October 2020 | A Phase II clinical trial to assess how safe and how effective AZD1656 is in treating COVID-19 in diabetic patients compared to placebo. | A Phase II, randomised, double-blind, placebo-controlled clinical trial to assess the safety and efficacy of AZD1656 in diabetic patients hospitalised with suspected or confirmed COVID-19. The ARCADIA Trial - ARCADIA | | St George Street Capital Ltd | 07/07/2020 | 20200707 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002211-21 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 31/07/2020 | 150 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United Kingdom | Clinical Trials | | 2a/2b Thrales End Business Centre, Thrales End Lane | info@sgscapital.org | +447901119230 | St George Street Capital Ltd | Inclusion criteria: <br>1. Male or Female.<br>2. Aged 18 and older.<br>3. Have either T1DM or T2DM.<br>4. Hospitalised with suspected or confirmed novel coronavirus (Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)) infection at time of enrolment, categorised as stage 3, 4 or 5 on the WHO Ordinal Scale for Clinical Improvement.<br>5. Blood glucose level at or above 4 mmol/L.<br>6. Able to take oral (tablet) formulation of medication.<br>7. Patient is able to provide written informed consent prior to initiation of any study procedures.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 90<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 60<br> | Exclusion criteria: <br>1. In the opinion of the clinical team, progression to intubation or mechanical ventilation is imminent and inevitable, within the next 24 hours, irrespective of the provision of treatments.<br>2. Patients admitted with primary suspected or proven Mycoplasma pneumoniae, Chlamydia pneumoniae and bacterial pneumonia, who acquired COVID-19 while hospitalized.<br>3. Treatment with immunomodulators or anti-rejection drugs within the last 3 months.<br>4. Pregnant or breast feeding.<br>5. Men, and women of child-bearing potential, unwilling to use highly effective contraception during their participation in the trial and for 2 weeks after study completion.<br>6. Anticipated transfer to another hospital which is not a study site within 72 hours.<br>7. Known sensitivity to any of the study medication/placebo excipients.<br>8. Prior dosing with AZD1656 on a previous clinical trial.<br>9. Patients admitted as a result of and receiving immediate treatment for an acute asthmatic attack, acute myocardial infarction, acute cerebrovascular event.<br>10. Any known non-COVID-19, non-diabetes related, serious condition which, in the opinion of the clinical team, makes the patient unsuitable for the trial.<br>11. Known history of drug or alcohol abuse within previous 12 months of screening.<br>12. Known history of HIV, hepatitis C or unresolved hepatitis B or severe liver disease.<br>13. Current or planned use of gemfibrozil or any other strong inhibitors of CYP2C8.<br>14. Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product (IMP) containing small molecule treatment(s) within 30<br>days or 5 half-lives (whichever is longer) prior to enrolment into this study, or containing biological treatment(s) within 3 months prior to entry into this study.<br> | COVID-19 <br>MedDRA version: 23.0
Level: LLT
Classification code 10084382
Term: Coronavirus disease 2019
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: AZD1656<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: AZD1656<br>Current Sponsor code: AZD1656<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 50-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: Please refer to protocol for details.;Primary end point(s): Clinical Improvement measured as the percentage of subjects at Day 14 who are in categories 1-3 according to the World Health Organization (WHO) 8-point Ordinal Scale for Clinical Improvement, comparing AZD1656 treatment to placebo.;Secondary Objective: Secondary objectives of this study are:<br>• To assess the extent to which AZD1656 supports maintenance of adequate glycaemic control in hospitalised diabetic patients with known or suspected COVID-19.<br>• To assess the safety and tolerability of AZD1656 in the management of diabetes in hospitalised diabetic patients with known or suspected COVID-19.<br>• To determine whether AZD1656 affects duration of hospital stay, requirement for mechanical ventilation or mortality in diabetic patients with known or suspected COVID-19.;Main Objective: To determine the effect of AZD1656 on the cardiorespiratory complications of COVID-19 in hospitalised diabetic patients with known or suspected COVID-19 disease, as measured using the WHO 8-point Ordinal Scale for Clinical Improvement compared to placebo. | | | | Yes | True | parent | |
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| EUCTR2020-001867-94-FR | 26 October 2020 | Effet du tenofovir/emtricitabine en cure courte sur la clairance virale chez des patients infectés par le SARS-CoV2 (COVID-19) non hospitalisés | Effet du tenofovir/emtricitabine en cure courte sur la clairance virale chez des patients infectés par le SARS-CoV2 (COVID-19) non hospitalisés - AR0-CORONA | | CHU CAEN Normandie | 20/04/2020 | 20200420 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001867-94 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 15/10/2020 | 180 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: prise en charge classique<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| France | Investigateur Coordinateur | | DRCI | parienti-jj@chu-caen.fr | 33231064320 | CHU CAEN Normandie | Inclusion criteria: <br>- Infection confirmée par le SARS-CoV2<br>- Patients ne nécessitant pas l’hospitalisation<br>- Consentement éclairé signé<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 180<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 180<br> | Exclusion criteria: <br>- Patients porteur du VIH ou de l’Hépatite B<br>- Contre-indication à l’utilisation du TDF/FTC<br>- Insuffisance rénale sévère connue <br>- Femmes enceintes ou allaitantes<br><br> | patients atteints d’une infection SARS-CoV2 non hospitalisés <br>MedDRA version: 20.0
Level: HLGT
Classification code 10021879
Term: Infections - pathogen unspecified
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Emtricitabine/Ténofovir disoproxil Mylan<br>Product Name: Emtricitabine/Ténofovir disoproxil Mylan<br>Pharmaceutical Form: Tablet<br><br> | Timepoint(s) of evaluation of this end point: J4;Primary end point(s): Négativation du portage nasopharyngé SARS-CoV2 par PCR à J4;Secondary Objective: • Réduction de la durée des symptômes<br>• Rapidité de la décroissance virale SARS-CoV2 entre J4 et J1<br>• Tolérance du TDF/FTC<br>• Proportion d’hospitalisation secondaire<br><br>;Main Objective: Efficacité de l’association tenofovir/emtricitabine pendant 7 jours sur la négativation du portage nasopharyngé de SARS-CoV2 à J4 | | | | Yes | False | | |
| → | EUCTR2020-003366-39-FR | 26 October 2020 | CAMOVID: A multicenter randomized trial to evaluate the efficacy and safety of camostat mesylate for the treatment of SARS-CoV-2 infection in ambulatory adult patients. | CAMOVID: A multicenter randomized trial to evaluate the efficacy and safety of camostat mesylate for the treatment of SARS-CoV-2 infection in ambulatory adult patients. | | Assitance Publique-Hopiaux de Paris | 13/07/2020 | 20200713 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-003366-39 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 16/10/2020 | 596 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: yes<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| France | | | | | | | Inclusion criteria: <br>1) Age > 18 y.o.<br>2) Laboratory confirmed SARS-CoV2 infection with mild COVID-19, fulfilling all the following criteria:<br>- Positive SARS-CoV-2 RT-PCR nasal swab samples<br>AND<br>- Clinical symptoms and signs consistent with SARS-CoV2 infection including but not limited to, fever, upper respiratory tract infection signs, digestive signs, muscle pain, anosmia, dysgeusia…[WHO]<br>3) Informed consent to participate to the trial <br>4) Patients must be able and willing to comply with study visits and procedures<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>1) Initial need for hospitalization for COVID-19 management : defined as any of the following severity criteria : respiratory rate > 24 /min at rest, Sp02 < 95% on room air, blood pressure < 100 mmHg, lethargy or unconsciousness, brutal overall deterioration or lethargy in the elderly (recommendations HCSP) all other reasons requiring immediate hospitalization left at the discretion of the physician<br>2) Pregnancy and breastfeeding<br>3) Participation to another interventional drug trial<br>4) Subject protected by law under guardianship or curatorship<br>5) Absence of health insurance<br>6) Known hypersensitivity to camostat mesylate<br>7) Known person sharing the same household already included in the study<br><br> | | <br>Trade Name: FOIPAN 100 mg<br>Product Name: Camostat mesilate<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: CAMOSTAT MESILATE<br>CAS Number: 59721-29-8<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 100-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br> | Main Objective: Evaluate the efficacy of camostat mesylate in the treatment of SARS-CoV-2 infection in adult patients with confirmed COVID-19 not requiring initial hospitalization, , in terms of hospitalization needs, up to day 21 after randomization;Secondary Objective: - Safety up to day 21<br>- Efficacy in terms of need for hospitalization for COVID-19 management, by independent blinded committee review<br>- Overall clinical improvement at day 21<br>- Clinical efficacy in terms of intensive care needs, up to day 21<br>- Clinical efficacy in terms of time to hospitalization, up to day 21<br>- Clinical efficacy on respiratory functions, up to day 21 <br>- Overall survival at day 21 and 90 after randomization<br>- Patient-reported outcome on initial symptoms, up to day 21 <br>- Virological, serological and immunological efficacy, up to day 21 <br>- Renal complications, up to day 21 <br>- Liver complications, up to day 14<br>;Primary end point(s): Proportion of patients hospitalized between day 1 and day 21, for COVID-19 deterioration.<br>Criteria for hospitalization will be the presence of any of the following: respiratory rate > 24 /min at rest, Sp02 < 95% on room air, blood pressure < 100 mmHg, lethargy or unconsciousness, brutal overall deterioration or lethargy in the elderly [HCSP] and any all other reasons requiring hospitalization left at the discretion of the physician<br>→Primary end point(s): Proportion of patients hospitalized between day 1 and day 21, for COVID-19 deterioration.<br>Criteria for hospitalization will be the presence of any of the following: respiratory rate > 24 /min at rest, Sp02 < 95% on room air, blood pressure < 100 mmHg, lethargy or unconsciousness, brutal overall deterioration or lethargy in the elderly [HCSP] and any all other reasons requiring hospitalization left at the discretion of the physician<br>;Secondary Objective: - Safety up to day 21<br>- Efficacy in terms of need for hospitalization for COVID-19 management, by independent blinded committee review<br>- Overall clinical improvement at day 21<br>- Clinical efficacy in terms of intensive care needs, up to day 21<br>- Clinical efficacy in terms of time to hospitalization, up to day 21<br>- Clinical efficacy on respiratory functions, up to day 21 <br>- Overall survival at day 21 and 90 after randomization<br>- Patient-reported outcome on initial symptoms, up to day 21 <br>- Virological, serological and immunological efficacy, up to day 21 <br>- Renal complications, up to day 21 <br>- Liver complications, up to day 14<br>;Main Objective: Evaluate the efficacy of camostat mesylate in the treatment of SARS-CoV-2 infection in adult patients with confirmed COVID-19 not requiring initial hospitalization, , in terms of hospitalization needs, up to day 21 after randomization | | | | Yes | False | | |
| EUCTR2020-001745-40-IT | 26 October 2020 | PILOT STUDY ON THE USE OF SARILUMAB IN PATIENTS WITH COVID-19 INFECTION | PILOT STUDY ON THE USE OF SARILUMAB IN PATIENTS WITH COVID-19 INFECTION - COVID-SARI-001 | | ASST FATEBENEFRATELLI SACCO | 24/06/2020 | 20200624 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001745-40 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 23/04/2020 | 40 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Italy | Dipartimento di Scienze Cliniche - | | Via G.B. Grassi 74 | agostino.riva@unimi.it | 0250319758 | ASST Fatebenefratelli Sacco | Inclusion criteria: <br>• Age = 18 years and < 85 years.<br>• Documented (chest X-Ray or TC scan), severe (BCRSS =3 and <4) interstitial pneumonia with respiratory failure (requiring supplemental oxygen) with positive Covid-19 swab testing.<br>• Worsening of respiratory exchanges such as to require ventilation with Venturi mask >31% (6L/minute).<br>• Increased levels of D-dimer (> 1500 ng/mL) or D-dimer progressively increasing (over 3 consecutive measurements) and reaching = 1000 ng/mL.<br>• Signed informed consent<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 15<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 25<br> | Exclusion criteria: <br>• Age < 18 years or = 85 years.<br>• AST / ALT > 5x ULN.<br>• Neutrophil count lower than 500 cells / mL.<br>• PTL count lower than 50,000 cells / mL.<br>• Documented sepsis due to infections other than Covid-19.<br>• Presence of serious co-morbidities (such as COPD, diabetes, or cardiomyopathies) likely to cause, according to the clinical judgment, an unfavorable outcome.<br>• Complicated diverticulitis or intestinal perforation.<br>• Immunosuppressive therapy due to organ transplant.<br> | Patients with COVID-19 infection <br>MedDRA version: 22.1
Level: LLT
Classification code 10048847
Term: Lung infection NOS
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Trade Name: Kevzara<br>Product Name: Kevzara<br>Product Code: [SAR153191]<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Sarilumab<br>CAS Number: 1189541-98-7<br>Current Sponsor code: SAR153191<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br><br> | Timepoint(s) of evaluation of this end point: Daily until discharge;Primary end point(s): Proportion of patients who show an improvement of the respiratory function, described as =30% decrease in oxygen requirement compared to baseline.;Secondary Objective: Potenziale efficacia di sarilumab nella polmonite Covid-19:<br>• Nei pazienti con febbre al basale, valutazione del tempo alla risoluzione della febbre, definita come temperatura corporea =36,6 ° C axilla, =37,8 ° C rettale o timpanica per almeno 48 ore senza antipiretici;<br>• Valutazione della carica virale, sangue ed espettorato per COVID-19 prima della somministrazione di sarilumab, 48 ore e 96 ore dopo la somministrazione;<br>• Valutazione della concentrazione plasmatica di Il-6, TNF-a, Il-10 e GM-CSF pre-trattamento e 96 e 120 ore dopo il trattamento;<br>• Valutazione del tasso di progressione della frazione WBC di granulociti immaturi - IG - (conteggi assoluti e%) e dei parametri morfologici-funzionali definiti da:<br>- complessità citoplasmatica<br>- intensità di fluorescenza<br>- dimensioni <br>- ampiezza di distribuzione degli eventi su entrambi gli assi del citogramma WDF.;Main Objective: To evaluate the safety and clinical efficacy of sarilumab in adult patients hospitalized due to severe Covid-19 pneumonia based on the proportion of patients who show an improvement of the respiratory function, described as =30% decrease in oxygen requirement compared to baseline. | | | | No | False | | |
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| JPRN-UMIN000042211 | 4 November 2020 | The impact of COVID-19 pandemic on colorectal cancer therapy | The impact of COVID-19 pandemic on colorectal cancer therapy - The impact of COVID-19 pandemic on colorectal cancer therapy | | Uji-Tokushukai Medical Center | 23/10/2020 | 20201023 | JPRN | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048176 | Not Recruiting | No | 16years-old | Not applicable | Male and Female | 2020/08/15 | 123 | Observational | Not selected Not selected | Not applicable | Japan | Mizuno | Rei | 145, Makishima-cho, Ishibashi, Uji, Kyoto | reimzn@kuhp.kyoto-u.ac.jp | 0774201111 | Uji-Tokushukai Medical Center Department of Surgery | Inclusion criteria: | Exclusion criteria: Patients deemed ineligible as study participants by the research director | COVID-19, Colorectal cancer | | The incidence of obstructive colorectal cancer | | 15/10/2020 | | No | False | | |
| → | ISRCTN13539303 | 9 November 2020 | An international registry of coronavirus exposure in pregnancy | International Registry of Coronavirus Exposure in Pregnancy (IRCEP) | | Pregistry LLC | 30/10/2020 | 20201030 | ISRCTN | http://isrctn.com/ISRCTN13539303 | Recruiting | No | | | Female | 08/06/2020 | 25000 | Observational | Prospective observational study (Other) | Not Applicable | Benin;Bermuda;Bhutan;Bolivia;Bonaire Saint Eustatius and Saba;Bosnia and Herzegovina;Botswana;Bouvet Island;Brazil;British Indian Ocean Territory;Brunei;Bulgaria;Burkina Faso;Burundi;Cambodia;Cameroon;Canada;Cape Verde;Cayman Islands;Belize;Belgium;Belarus;Barbados;Bangladesh;Bahrain;Bahamas;Azerbaijan;Austria;Australia;Aruba;Armenia;Argentina;Antigua and Barbuda;Antarctica;Anguilla;Angola;Andorra;American Samoa;Algeria;Albania;Aland Islands;Afghanistan;Cook Islands;Central African Republic;Eritrea;Estonia;Ethiopia;Falkland Islands;Faroe Islands;Fiji;Finland;France;French Guiana;French Polynesia;French Southern Territories;Gabon;Gambia;Georgia;Germany;Ghana;Gibraltar;Greece;Greenland;Grenada;Guadeloupe;Guam;Guatemala;Guernsey;Guinea;Guinea-Bissau;Guyana;Haiti;Heard Island and Mcdonald Islands;Holy See (Vatican City State);Honduras;Hong Kong;Chad;Chile;China;Christmas Island;Cocos (Keeling) Islands;Colombia;Comoros;Congo;Congo, Democratic Republic;Costa Rica;Cote d'Ivoire;Croatia;Cuba;Curacao;Cyprus;Czech Republic;Denmark;Djibouti;Dominica;Dominican Republic;Ecuador;Egypt;El Salvador;Equatorial Guinea;Hungary;Iceland;India;Indonesia;Iran;Iraq;Ireland;Isle of Man;Israel;Italy;Jamaica;Japan;Jersey;Jordan;Kazakhstan;Kenya;Kiribati;Korea, North;Korea, South;Kosovo;Kuwait;Kyrgyzstan;Laos;Latvia;Lebanon;Lesotho;Liberia;Libya;Liechtenstein;Lithuania;Luxembourg;Macao;Macedonia;Madagascar;Malawi;Malaysia;Maldives;Mali;Malta;Marshall Islands;Martinique;Mauritania;Mauritius;Mayotte;Mexico;Micronesia, Federated States of;Moldova;Monaco;Mongolia;Montenegro;Montserrat;Morocco;Mozambique;Myanmar;Namibia;Nauru;Nepal;Netherlands;Netherlands Antilles;New Caledonia;New Zealand;Nicaragua;Niger;Nigeria;Niue;Norfolk Island;Northern Mariana Islands;Norway;Oman;Pakistan;Palau;Palestinian Territory;Panama;Papua New Guinea;Paraguay;Peru;Philippines;Pitcairn;Poland;Portugal;Puerto Rico;Qatar;Reunion;Romania;Russian Federation;Rwanda;Saint Barthelemy;Saint Helena;Saint Kitts and Nevis;Saint Lucia;Saint Martin (French part);Saint Pierre and Miquelon;Saint Vincent and the Grenadines;Samoa;San Marino;Sao Tome and Principe;Saudi Arabia;Senegal;Serbia;Seychelles;Sierra Leone;Singapore;Sint Maarten (Dutch part);Slovakia;Slovenia;Solomon Islands;Somalia;South Africa;South Georgia and the South Sandwich Is;South Sudan;Spain;Sri Lanka;Sudan;Suriname;Svalbard and Jan Mayen;Swaziland;Sweden;Switzerland;Syria;Taiwan;Tajikistan;Tanzania;Thailand;Timor-Leste;Togo;Tokelau;Tonga;Trinidad and Tobago;Tunisia;Turkey;Turkmenistan;Turks and Caicos Islands;Tuvalu;Uganda;Ukraine;United Arab Emirates;United Kingdom;United States Minor Outlying Islands;United States of America;Uruguay;Uzbekistan;Vanuatu;Venezuela;Viet Nam;Virgin Islands, British;Virgin Islands, U.S.;Wallis and Futuna;Western Sahara;Yemen;Zambia;Zimbabwe | Diego;Sonia→Sonia;Diego | Wyszynski;Hernandez-Diaz | 8 Albert Road;677 Huntington Avenue | diegow@pregistry.com;shernan@hsph.harvard.edu | +1 (747) 200-5468 ;+1 (617) 432-3942 | ; | Inclusion criteria: Adult pregnant women with clinical confirmation of COVID-19 or tested for SARS-CoV-2 at any time during their pregnancy | Exclusion criteria: Subjects who do not meet the inclusion criteria | COVID-19 (SARS-CoV-2 infection) during pregnancy <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> The IRCEP will be an observational cohort study with prospective and retrospective components. Registration and participation via website or mobile app specially developed for the IRCEP will be voluntary. Women 18 years of age and older will be encouraged to enrol if at any time during pregnancy, they had a test performed for the coronavirus (regardless of the result) or if they had clinical confirmation of COVID-19 in the absence of a SARS-CoV-2 test. Women with confirmed COVID-19 via clinical or test methods will be included in the exposed group and women with a negative test will be included in the control group. Eligible women will be able to enrol at any time during gestation. Given the public health emergency due to the COVID-19 pandemic and the urgent need for data, the IRCEP will also enrol eligible women retrospectively during the first 180 days after delivery (if they delivered after December 2019).<br><br> As numbers accumulate, the natural history of COVID-19 during pregnancy will be reported stratified by days since COVID-19 confirmation at enrollment (i.e., from prospective if immediate to retrospective if enrolled after resolution) and the risk of pregnancy outcomes by COVID-19 exposure group will be reported stratified by trimester at enrollment. For the assessment of miscarriages, only participants enrolled during the first trimester will be included and the analyses will be stratified by gestational week at enrollment. For other outcomes, the primary analysis will include all enrollees. However, sensitivity analyses of 1) teratogenicity will be restricted to participants enrolled before an informative prenatal screening was done; 2) late-pregnancy outcomes (e.g. preeclampsia) will be restricted to participants enrolled before | <br> Measured by maternal self-report using online questionnaire at baseline:<br> 1. Pregnancy outcomes:<br> 1.1. Miscarriage (or spontaneous abortion)<br> 1.2. Elective termination<br> 1.3. Stillbirth<br> 1.4. Preterm delivery<br> 2. Birth outcomes (measured at additional time points up to 90 days):<br> 2.1. Major structural defects<br> 2.2. Neonatal death<br> 2.3. Admission into the Neonatal Intensive Care Unit<br> 2.4. Maternal obstetric complications<br> 2.5. Post-partum health<br> | | 30/04/2024 | | No | False | | |
| ISRCTN13455972 | 9 November 2020 | Evaluation of coronavirus self-isolation interventions | Do SMS reminders or calls increase the public's compliance with self-isolation advice in the UK? A randomised controlled field trial | | Department of Health and Social Care | 04/08/2020 | 20200804 | ISRCTN | http://isrctn.com/ISRCTN13455972 | Not Recruiting | No | | | Both | 04/08/2020 | 10000 | Interventional | Randomised controlled field trial (Prevention) | Not Applicable | United Kingdom | Clare | Delargy |
The Behavioural Insights Team
4 Matthew Parker Street
| | | | Inclusion criteria: <br> The researchers aim to recruit 10,000 participants into the sample over the trial period using a pipeline method. All contacts will be eligible for the trial if:<br> 1. They are entered into the CTAS system since trial launch and have been successfully given isolation advice (Contacts are entered into the CTAS system if they are entered into the CTAS web form either by someone who has tested positive for coronavirus, or a call handler on behalf of someone who has tested positive)<br> 2. They are over 18<br> 3. CTAS has either a mobile phone number, or a landline number and email address<br> | Exclusion criteria: <br> 1. Minors (less than 18 years old)<br> 2. CTAS does not have their mobile phone number, or a landline number and email address<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> Randomised controlled field trial with three treatment arms (SMS only; Call only; SMS plus call) and two control arms. The first control arm will be used to assess the effectiveness of each treatment arm in the final phone survey. The second control arm will be used to assess the effectiveness of each treatment arm in the SMS/email survey.<br><br> Interventions<br> Support communications delivered to people who have been in contact with someone who tested positive for coronavirus and are advised to self-isolate for 14 days.<br><br> Randomisation<br> Participants will be randomised at the individual level to the five arms in daily batches as they enter the Contact Tracing and Advice Service (CTAS).<br><br> Arms:<br> 1. Business as usual (BAU) (control 1): No communication between the initial call and final phone survey at the end of self-isolation period.<br> 2. BAU+ (control 2): Participants receive only the interim SMS/email survey (day 10 and 15) + final phone survey.<br> 3. Daily SMS/email: Participants receive daily support SMS/email self-isolation messages (day 1 to 14 inclusive) and interim SMS/email survey (day 10 and 15) + final phone survey (SMS will be replaced by email if the participant does not have a mobile number, but still has a landline number).<br> 4. 2x calls: Participants receive 2x support call from contact tracing call handlers (day 3 and 8) and interim SMS/email survey (day 10 and 15) + final phone survey.<br> 5. Daily SMS/email + 2x calls: Participants receive daily support SMS/email self-isolation messages (day 1 to 14 inclusive), 2x support call (day 3 and 8) and interim SMS/email survey (day 10 and 15) + final phone s | Number of times a person reports leaving the house while self-isolating, as reported in SMS survey on day 15 of self-isolation | | 30/09/2020 | | Yes | False | | |
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| EUCTR2020-001934-37-ES | 16 November 2020 | USE OF CORTICOSTEROIDS IN PATIENTS WITH SARS-COV2 CORONAVIRUS INFECTION | USE OF CORTICOSTEROIDS IN PATIENTS WITH SARS-COV2 CORONAVIRUS INFECTION (GLUCOCOVID). Pragmatic trial inserted in real practice during a pandemic COVID-19 - USE OF CORTICOSTEROIDS IN PATIENTS WITH SARS-COV2 CORONAVIRUS INFECTION | | IDIVAL Instituto de Investigación Sanitaria Valdecilla | 08/05/2020 | 20200508 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001934-37 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 07/05/2020 | 200 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Comprehensive cohort design
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Standard treatment (according to each center's protocols)
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Spain | Mar García Sáiz | | Avenida de Valdecilla s/n | mmar.garcia@scsalud.es | 34942203333 | IDIVAL | Inclusion criteria: <br>- Patients admitted to hospital with Covid-19, confirmed by microbiological tests or compatible clinical manifestations, with exclusion of other infections.<br>- Age: 18-85 years old.<br>- Time of evolution: more than 7 days since the beginning of symptoms.<br>- Evidence of inflammation, defined by: Lung infiltrates + Gas exchange disturbance: PaO2 < 65 or Sat<93% (breathing air), or PAFI <300, or SAFI <440, or BCRSS =2 + Elevated biomarkers: PCR >15, or DD>800, or Ferritin >1000, or IL6>20<br>- Absence of bacterial infection or other disease that explains the lung disorder.<br>- Verbal informed consent, which will be recorded in history.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 120<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 80<br> | Exclusion criteria: <br>- Refusal to participate<br>- Pregnancy<br>- Established indication for mechanical ventilation, non-invasive ventilation or ICU admission<br>- Immunosuppression<br>- Chronic renal failure on dialysis<br> | SARS-CoV-2 infection (COVID-19) <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Urbason/Metilprednisolona<br>Pharmaceutical Form: Powder and solvent for solution for injection<br>INN or Proposed INN: METHYLPREDNISOLONE<br>CAS Number: 83-43-2<br>Current Sponsor code: -<br>Other descriptive name: METHYLPREDNISOLONE<br>Concentration unit: mg milligram(s)<br>Concentration type: range<br>Concentration number: 20-40<br><br> | Timepoint(s) of evaluation of this end point: At the time of discharge or death;Primary end point(s): Combination of death, ICU stay or non-invasive ventilation (NIV).;Secondary Objective: To evaluate the safety of early anti-inflammatory treatment with corticosteroids;Main Objective: To evaluate the efficacy of early anti-inflammatory treatment with corticosteroids in patients who are in a phase of the disease in which viral replication has already been limited, but there is a marked systemic inflammatory response. | | | | No | False | | |
| → | EUCTR2020-001474-29-ES | 16 November 2020 | Pilot study to evaluate the potential of ivermectin to reduce COVID-19 transmission | Pilot study to evaluate the potential of ivermectin to reduce COVID-19 transmission | | Clínica Universidad de Navarra/Universidad de Navarra | 08/05/2020 | 20200508 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001474-29 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 07/05/2020 | 24 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | UCEC | | Avda. Pío XII, 36 | ucicec@unav.es | 9482554002717 | Clinica Universidad de Navarra | Inclusion criteria: <br>-Patients diagnosed with COVID-19 in the emergency room of the Clínica Universidad de Navarra with a positive SARS-CoV-2 PCR.<br>-Residents of the Pamplona basin (“Cuenca de Pamplona”)<br>-The patient should be between the ages of 18 and 60 years of age<br>-Negative pregnancy test for women of child bearing age*<br>-The patient or his/her representative, have given consent to participate in the study.<br>-The patient should, in the investigator's opinion, be able to comply with all the requirements of the clinical trial (including home follow up during isolation)<br><br>*Women of child bearing age may participate if they use a safe contraceptive method for the entire period of the study and at least one month afterwards. A woman is considered to not have childbearing capacity if she is post-menopausal (minimum of 2 years without menstruation) or has undergone surgical sterilization (at least one month before the study).<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 24<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>- Known history of Ivermectin allergy<br>-Hypersensitivity to any component of Stromectol®<br>-COVID-19 Pneumonia Diagnosed by the attending physician Identified in a chest X-ray<br>-Fever or cough present for more than 48 hours<br>-Positive IgG against SARS-CoV-2 by rapid test<br>-Age under 18 or <br>-over 60 years<br>-Immunosuppression <br>-Chronic Obstructive Pulmonary Disease <br>-Diabetes<br>-Hypertension<br>-Obesity<br>-Acute or chronic renal failure<br>-History of coronary disease<br>-History of cerebrovascular disease<br>-Current neoplasm<br>-Recent travel history to countries that are endemic for Loa loa (Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan)<br>-Current use of CYP 3A4 or P-gp inhibitor drugs (such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin.)<br> | COVID-19 <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Stromectol<br>Product Name: Ivermectina<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Ivermectin<br>CAS Number: 70288-86-7<br>Other descriptive name: IVERMECTIN<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 3-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br> | Main Objective: To determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day seven post-treatment.;Timepoint(s) of evaluation of this end point: Day 7 post-treatment;Primary end point(s): Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab;Secondary Objective: 1. To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab at day seven post treatment<br>2. To assess the efficacy of ivermectin to improve symptom progression in treated patients<br>3. To assess the proportion of seroconversions at day 21 in treated patients<br>4. To assess the safety of ivermectin at the proposed dose<br>5. To determine the magnitude of immune response against SARS-CoV-2 <br>6. To assess the early kinetics of immunity against SARS-CoV-2→Main Objective: To determine the efficacy of a single dose of ivermectin, administered to low risk, non-severe COVID-19 patients in the first 48 hours after symptoms onset to reduce the proportion of patients with detectable SARS-CoV-2 RNA by PCR from nasopharyngeal swab at day seven post-treatment.;Secondary Objective: 1. To assess the efficacy of ivermectin to reduce the SARS-CoV-2 viral load in the nasopharyngeal swab at day seven post treatment<br>2. To assess the efficacy of ivermectin to improve symptom progression in treated patients<br>3. To assess the proportion of seroconversions at day 21 in treated patients<br>4. To assess the safety of ivermectin at the proposed dose<br>5. To determine the magnitude of immune response against SARS-CoV-2 <br>6. To assess the early kinetics of immunity against SARS-CoV-2;Timepoint(s) of evaluation of this end point: Day 7 post-treatment;Primary end point(s): Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab | | | | No | False | | |
| EUCTR2020-001953-36-ES | 16 November 2020 | Study to Evaluate the Safety and Efficacy of Prolastin in Hospitalized Patients with Coronavirus Disease (COVID-19) | A Multicenter, Randomized, Open-label, Parallel Group Pilot Study to Evaluate the Safety and Efficacy of Prolastin® plus Standard Medical Treatment (SMT) versus SMT alone in Hospitalized Subjects with COVID-19. | | Instituto Grifols, S.A | 08/05/2020 | 20200508 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001953-36 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 08/05/2020 | 100 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Standartd Medical Treatment
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | Department of Clinical Trials | | Av. Generalitat 152 | IGregulatory.affairs@grifols.com | 34935712000 | Instituto Grifols, S.A. | Inclusion criteria: <br>1. Hospitalized male or female patient = 18 years of age at time of Screening who is being treated for COVID-19. Subjects must be screened within 48 hours (= 48 hours) of hospital admission.
<br>2. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by qualitative PCR (reverse transcriptase [RT]-PCR), or other commercial or public health assay in any specimen < 72 hours prior to randomization.
<br>3. COVID-19 illness (symptoms) of any duration, including both of the following:
<br>a) Radiographic infiltrates by imaging (chest X-Ray, CT scan, etc.) and/or clinical assessment (evidence of rales/crackles on exam) with SpO2 <94% on room air
<br>b) Any One of the following related to COVID-19: i. Ferritin > 400ng/mL, ii. LDH > 300 U/L, iii. D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 mg/L
<br>4. Subject provides informed consent (ICF) prior to initiation of any study procedures.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 50<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 50<br> | Exclusion criteria: <br>1. Patients requiring invasive mechanical ventilation or ICU admission or with PaO2/FIO2 = 150 mm Hg (ie, arterial oxygen in mm Hg divided by fraction inspired oxygen concentration [eg, 0.21 for room air]).
<br>2. Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the subject at undue medical risk.
<br>3. The subject has had a known serious anaphylactic reaction to blood, any blood-derived or plasma product, or known Selective IgA Deficiency with anti-IgA antibodies.
<br>4. A medical condition in which the infusion of additional fluid is contraindicated (e.g., decompensated congestive heart failure or renal failure with fluid overload).
<br>5. Shock that is unresponsive to fluid challenge and/or multiple vasopressors and accompanied by multiorgan failure considered not able to be reversed by the Principal Investigator.
<br>6. Known alpha-1 antitrypsin deficiency for which the patient is already receiving alpha1-proteinase inhibitor augmentation therapy.
<br>7. Women who are pregnant or breastfeeding. Female subjects of child-bearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at Screening/Baseline Visit.
<br>8. Patients for whom there is limitation of therapeutic effort such as “Do not resuscitate” status Note: If the decision is made not to apply treatments or therapeutic procedures that will provide little benefit for the suffering or agony the patient is experiencing, such a patient would not be appropriate for participation in this study and should be excluded.
<br>9. Currently participating in another interventional clinical trial with investigational medical product or device
<br>10. Patients previously requiring long-term oxygen therapy (home oxygen therapy)<br> | Patients with Coronavirus Disease (COVID-19) <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
<br>MedDRA version: 23.0
Level: LLT
Classification code 10053983
Term: Corona virus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Prolastina 1000 mg, polvo y disolvente para solución para perfusión<br>Pharmaceutical Form: Powder and solvent for solution for infusion<br>INN or Proposed INN: Alpha1-Proteinase Inhibitor (Human)<br>Other descriptive name: HUMAN ALPHA1-PROTEINASE INHIBITOR<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1000-<br><br> | Main Objective: To determine if Prolastin plus SMT can reduce the proportion of subjects dying or requiring intensive care unit (ICU) admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15 versus SMT alone in hospitalized subjects with COVID-19.;Secondary Objective: To compare Prolastin plus SMT versus SMT alone with regard to clinical efficacy as assessed by clinical severity, duration of hospital stay, dependency on oxygen or new need for ventilatory support, or ICU admission, clinical response criteria including National Early Warning Score (NEWS), mortality and clinical status scale through Day 29 in hospitalized subjects with COVID-19.;Primary end point(s): The primary efficacy variable is the proportion of subjects dying or requiring ICU admission on or before Day 15 or who are dependent on invasive mechanical ventilation on Day 15.;Timepoint(s) of evaluation of this end point: Through Day 29 | | | | Yes | True | parent | |
| EUCTR2020-001512-26-DE | 16 November 2020 | Hydroxychloroquine for the treatment of mild COVID-19 disease | Hydroxychloroquine for the treatment of mild COVID-19 disease | | Universitätsklinikum Tübingen | 01/04/2020 | 20200401 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001512-26 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 22/04/2020 | 2700 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany | Diane Egger-Adam | | Wilhelmstr. 27 | diane.egger-adam@uni-tuebingen.de | +4970712982191 | Univeristätsklinikum Tübingen | Inclusion criteria: <br>• Must be =18 years at the time of signing the informed consent<br>• Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures<br>• Able to adhere to the study visit schedule and other protocol requirements<br>• Mild COVID-19 with outpatient management as decided by the treating physician<br>• Early warning score for 2019-nCoV infected patients = 4<br>• Females of childbearing potential (FCBP) must agree: <br>o to practice continuous effective contraception for at least 28 days before starting study drug, while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe (a method which results in a failure rate less than 1% per year) <br>o to abstain from breastfeeding during study participation and 28 days after study drug discontinuation<br>• All subjects must agree to refrain from donating blood while on study drug and for 28 days after discontinuation from this study treatment<br>• All subjects must agree not to share medication<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 2360<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 340<br> | Exclusion criteria: <br>• Requirement for supplemental oxygen <br>• Shortness of breath in resting position<br>• Early warning score of 3 in one of the categories:<br>o Respiratory rate (=8 or =25 breaths/min) <br>o Systolic blood pressure (=90 mmHg or =220 mmHg)<br>o Heart rate (=40 or = 130 beats/min)<br>• Known or suspected renal insufficiency <br>• Known glucose-6-phosphate-dehydrogenase deficiency (favism)<br>• Known Myasthenia gravis<br>• Ongoing disorders of the hemopoietic system<br>• Known hypersensitivity against 4-amino-quinolines<br>• Women during pregnancy and lactation<br>• Current participation in other clinical interventional trials<br>• Elevated Tisdale score for QTc prolongation (score between 7-21) <br>• History or current evidence of clinically significant cardiac arrhythmia except atrial fibrillation or paroxysmal supraventricular tachycardia<br>• Active or clinically significant cardiac disease including congestive heart failure (New York Heart Association Class III or higher)<br>• Epilepsy<br>• Physician decision that involvement in the study is not in the patient´s best interest<br> | Acute coronavirus disease 2019 <br>MedDRA version: 23.0
Level: LLT
Classification code 10053983
Term: Corona virus infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Quensyl<br>Pharmaceutical Form: Capsule<br>INN or Proposed INN: Hyroxychloroquine sulfate<br>CAS Number: 747-36-4<br>Other descriptive name: HYDROXYCHLOROQUINE SULFATE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br>Pharmaceutical form of the placebo: Capsule<br>Route of administration of the placebo: Oral use<br><br> | Main Objective: Difference in time to resolution of clinical signs and symptoms of mild COVID-19 treated with hydroxychloroquine or placebo as assessed by daily self-assessment;Secondary Objective: Difference between hydroxychloroquine- and placebo-treated patients on an ordinal outcome scale until Day 28 (death, admission to intensive care, hospitalization, continuing disease, recovered)<br><br>All-cause mortality within 28 days<br>;Primary end point(s): The primary endpoint will be the difference in duration from the initiation of treatment until resolution of the clinical signs and symptoms assessed by daily self-assessment in hydroxychloroquine- versus placebo-treated patients.;Timepoint(s) of evaluation of this end point: One interim analysis for evaluating the primary efficacy endpoint is planned for this study. The interim analysis will be done when 40% of events have accrued. A one-sided Hwang-Shih-DeCani spending function with gamma = -4 (alpha-spending) was considered in the sample size calculation to account for multiplicity repeated tests. In case the interim analysis shows a HR > 1.21 (nominal p < 0.0018), efficacy is shown and the trial may be stopped. <br>Final analysis upon completion of the trial and final database lock | | | | Yes | False | | |
| → | EUCTR2020-001903-17-ES | 16 November 2020 | Effects of Tocilizumab and its combination with Vitamin D to treat the increased defensive response in COVID-19 | A randomized clinical trial (IIIb) of eficacy of a single dose of Tocilizumab or a combination of Tocilizumab plus Vitamin D (single i.m. dose) for the treatment of the COVID-19 hyperimmune complication. Assessment of IL-6. - Tocilizumab vs. its combination with Vitamin D. Variation in IL-6 | | HOSPITAL UNIVERISTARIO DE MOSTOLES | 15/05/2020 | 20200515 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001903-17 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 10/06/2020 | 120 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: yes
Other specify the comparator: TOCILIZUMAB
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Spain | MEDICAL DIRECTOR | | RIO JUCAR S/N | NIEVES.TARIN@SALUD.MADRID.ORG | 349466486008620 | HOSPITAL DE MOSTOLES | Inclusion criteria: <br>PATIENTS IN A MODERATE TO SEVERE DEGREE (4-7 IN WHO SEVERITY SCALE)<br>NEEDING OXYGEN THERAPY<br>Dímer D> 1.500, CRP> 60 OR Ferritin >800 (AT LEAST 2 OF THEM)<br>Alternatively IL-6 >40<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 60<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 60<br> | Exclusion criteria: <br>PCR - AT ALL TIMES DESPITE BEING CONSIDERED COVID POSITIVE<br>IMMUNE INCOPETENCE BY CANCER TREATED IN THE LAST 12 MONTHS OR MEDICALLY INDUCED.<br>ACTIVE TUBERCULOSIS<br>PREVIOUSLY TREATED WITH TOCILIZUMAB<br>TREATED WITH METILPREDNISOLONE BOLUS. SINGLE DOSIS OF HYDROXYCORISONE OR ORAL CORTICOSTEROIDS ALLOWED<br>ALLERGY TO VITAMIN D<br>TREATED WITH REMDESIVIR AT AN EARLY STAGE<br> | COVID INFECTION IS A MILD FLU LIKE CONDITION WITH MILD FEVER, DRY COUGH, WIDESPREAD TENDERNESS AND OLFACTORY DISFUNCTION FOLLOWED BY A SERIOUS SITUATION IN SOME 20% OF PATIENTS WITH OVERT FEVER, MALAISE, CHILLS AND DYSPNEA DUE TO HYPERIMMUNE RESPONSE. OXYGEN IS LIKELY TO BE GIVEN IN ABOUT 70% OF PATIENTS AND MORTALITY RATE VARIES FROM 10 TO 40% OF SEVERE CASES.;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Tocilizumab (Actemra/RoActemra)™ , Roche<br>Product Name: Tocilizumab (Actemra/RoActemra)™ , Roche<br>Product Code: L04AC07<br>Pharmaceutical Form: Solution for injection/infusion<br>INN or Proposed INN: tocilizumab<br>CAS Number: 375823-41-9<br><br>Trade Name: VITAMINE D3 BON 200 000 U.I./1 ml, solution injectable IM en ampoule, boîte de 1 ampoule<br>Product Name: VITAMINE D3 BON 200 000 U.I./1 ml, solution injectable<br>Product Code: A11CC05<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: vitamin d3<br>Other descriptive name: CHOLECALCIFEROL CONCENTRATE (WATER-DISPERSIBLE FORM)<br><br> | Main Objective: Principal Objective: Reduce number of patients with fatal outcome.;Secondary Objective: Secondary Objectives:<br>- Assessment of the effect of treatment on inflammatory parameters, in particular IL-6<br>- Assesment of time to change in the scale of severity, WHO scale.;Primary end point(s): GLOBAL SURVIVAL RATE iT IS ACCOUNTED FOR THE MORTALITY RELATED TO THE INFECTIOUS AND IMMUNOLOGICAL COURSE PROVOKED BY SARS-COV2.;Timepoint(s) of evaluation of this end point: FIRST TO OCCUR, DISCHARGE OR DEATH WITHIN 30 DAYS FOROM SCREENING→Timepoint(s) of evaluation of this end point: FIRST TO OCCUR, DISCHARGE OR DEATH WITHIN 30 DAYS FOROM SCREENING;Primary end point(s): GLOBAL SURVIVAL RATE iT IS ACCOUNTED FOR THE MORTALITY RELATED TO THE INFECTIOUS AND IMMUNOLOGICAL COURSE PROVOKED BY SARS-COV2.;Secondary Objective: Secondary Objectives:<br>- Assessment of the effect of treatment on inflammatory parameters, in particular IL-6<br>- Assesment of time to change in the scale of severity, WHO scale.;Main Objective: Principal Objective: Reduce number of patients with fatal outcome. | | | | Yes | False | | |
| EUCTR2020-002114-40-FR | 16 November 2020 | Nintedanib for the treatment of pulmonary fibrosis induced by Covid-19 | Nintedanib for the treatment of SARS-Cov-2 induced pulmonary fibrosis - NINTECOR | | Assistance Publique - Hôpitaux de Paris | 17/06/2020 | 20200617 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002114-40 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 30/07/2020 | 250 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| France | Project Manager | | 1 Avenue Claude Vellefaux | didier.bouton@aphp.fr | 330144841744 | Assistance Publique - Hôpitaux de Paris | Inclusion criteria: <br>Age > 18 years and <89 years<br>- History of hospitalization for COVID-19 infection documented with positive PCR or positive serology in the previous 2 to 6 months<br>- Lung opacities on HRCT involving more than 10% of the lung volume, with fibrotic features <br>- DLCO= 70% predicted<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) no<br>F.1.2.1 Number of subjects for this age range 200<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 50<br> | Exclusion criteria: <br>- Pre-existing lung disorder with abnormal HRCT (including COPD, lung cancer, or pulmonary fibrosis)<br>- Recent surgery with wound healing in progress<br>- Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).<br>- Significant pulmonary arterial hypertension (PAH) defined by any of the following:<br>a. Previous clinical or echocardiographic evidence of significant right heart failure<br>b. History of right heart catheterisation showing a cardiac index =2 L/min/m²<br>c. PAH requiring parenteral therapy with epoprostenol/treprostinil.<br>- History of cardiovascular diseases, any of the following:<br>a. Severe hypertension, uncontrolled under treatment (=160/100 mmHg), within 6 months of Visit 1<br>b. Myocardial infarction within 6 months of Visit 1<br>c. Unstable cardiac angina within 6 months of Visit 1.<br>- Bleeding risk, any of the following:<br>a. Known genetic predisposition to bleeding.<br>b. Patients who require<br> i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, heparin, hirudin)<br> ii. High dose antiplatelet therapy.<br>- Pregnancy or lactation (women of childbearing capacity are required to have a negative serum pregnancy test before treatment and must agree to maintain highly effective contraception by practicing abstinence or by using at least two methods of birth control from the date of consent to three months after the end of the patient study participation). <br>- Alcohol or drug abuse which in the opinion of the treating physician would interfere with treatment.<br>- Ongoing or past antifibrotic treatment with pirfenidone or nintedanib <br>- Hypersensitivity to nintedanib, peanut or soya or to any of the excipients of the specialty Ofev®<br>- Patients not able to understand and follow study procedures including completion of self-administered questionnaires without help.<br>- No written informed consent from the patient<br>- Absence of affiliation to the French social security<br>- Participation in another interventional research<br> | Patients 2 to 6 months after Covid-19 acute pneumonia;Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] | <br>Trade Name: OFEV 150 mg<br>Pharmaceutical Form: Capsule, soft<br>INN or Proposed INN: Nintedanib<br>CAS Number: 656247-17-5<br>Current Sponsor code: Nintedanib<br>Other descriptive name: NINTEDANIB<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br>Pharmaceutical form of the placebo: Capsule, soft<br>Route of administration of the placebo: Oral use<br><br>Trade Name: OFEV 100 mg<br>Pharmaceutical Form: Capsule, soft<br>INN or Proposed INN: Nintedanib<br>CAS Number: 656247-17-5<br>Current Sponsor code: Nintedanib<br>Other descriptive name: NINTEDANIB<br>Concentration unit: mg/g milligram(s)/gram<br>Concentration type: equal<br>Concentration number: 100-<br>Pharmaceutical form of the placebo: Capsule, soft<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: LSLV;Primary end point(s): annual rate of decline in FVC from inclusion to 12 months, assessed by spirometry in accordance with international guidelines. Annual rate of decline in FVC will be estimated by linear regression from FVC measurements at inclusion and at 3, 6, 9 and 12 months.;Secondary Objective: 1. To compare the rate of decline of DLCO over 12 months <br>2. To compare exercise capacity at 12 months <br>3. To compare high resolution CT (HRCT) lung fibrosis extension at 12 months <br>4. To compare change in health-related quality of life <br>5. To compare the evolution of dyspnea over time <br>6. To compare change in Depression and anxiety over time <br>7. To compare change in lung injury, pulmonary hypertension and inflammation biomarkers<br>8. To assess pulmonary hypertension prevalence at inclusion and 12 months <br>9. To assess association between genetic susceptibility (MUC5B polymorphism) and lung fibrosis in COVID-19 survivors <br>10. To assess safety of nintedanib;Main Objective: to assess whether nintedanib slows the progression of lung fibrosis in COVID-19 survivors as assessed by the decline in the forced vital capacity (FVC) over 12 months compared to placebo | | | | Yes | False | | |
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| EUCTR2020-001736-95-GB | 16 November 2020 | A Phase 2 Study for the Treatment of COVID 19 in Hospitalised Patients | ACCORD 2: A Multicentre, Seamless, Phase 2 Adaptive Randomisation Platform Study to Assess the Efficacy and Safety of Multiple Candidate Agents for the Treatment of COVID 19 in Hospitalised Patients - ACCORD 2-Treatment of COVID 19 in Hospitalised Patients | | University Hospital Southampton NHS Foundation Trust | 23/04/2020 | 20200423 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001736-95 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 28/04/2020 | 1800 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: SOC control arm
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: SOC control arm
Number of treatment arms in the trial: 4
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United Kingdom | Emma Perry | | Southampton General Hospital, Level E, Laboratory & Pathology Block, SCBR - MP138 | sponsor@uhs.nhs.uk | | University Hospital Southampton NHS Foundation Trust | Inclusion criteria: <br>Patients are eligible to be included in the study only if all of the following criteria apply (as well as all criteria from the appropriate sub-protocol):<br>1. Adults (=18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests (which may include results from a test that was performed prior to hospital admission if, in the opinion of the Investigator, it is relevant to ongoing COVID-19).<br>2. Patients with symptoms and/or signs consistent with COVID-19, requiring treatment.<br>3. A score of Grade 3 to 5 on the 9-point ordinal scale.<br>4. a) Male patients:<br>• A male patient must agree to use contraception as detailed in Appendix 5 of this protocol during the treatment period and for at least 90 days after the last dose of study treatment and refrain from donating sperm during this period.<br>b) Female patients:<br>• A female patient is eligible to participate if she is not pregnant (see Appendix 5), not breastfeeding, and at least 1 of the following conditions applies:<br>i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5.<br>OR<br>ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 90 days after the last dose of study treatment.<br>5. Women who are lactating who agree not to breastfeed their child during the study and for a fixed period of time (following guidance that will be given by the investigator as appropriate for any candidate agent administered) after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded).<br>6. Ability to provide informed consent signed by the study patient or legally authorised representative.<br><br>In addition for the sub-protocol ACCORD-2-006:<br>Antibiotic prophylaxis: PLEASE NOTE that, according to Protocol Section 4.1.1.1, all patients must take antibiotic prophylaxis concomitantly, starting with the first dose of zilucoplan.<br><br>For the sub-protocol ACCORD-2-002:<br>Inclusion criteria 4 and 5 will be modified from the Master Protocol, as the contraception requirements will need to be for 120 days (not 90 days) after termination of study therapy, and breastfeeding restrictions will be for a similar time period. The revised criteria will be as follows:<br>4.a) Male patients:<br>• A male patient must agree to use contraception as detailed in Appendix 5 of the Master Protocol during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period.<br>b) Female patients: <br>• A female patient is eligible to participate if she is not pregnant (see Appendix 5 of the Master Protocol), not breastfeeding, and at least 1 of the following conditions applies:<br>i) Not a woman of childbearing potential (WOCBP) as defined in Appendix 5 of the Master Protocol.<br>OR<br>ii) A WOCBP who agrees to follow the contraceptive guidance in Appendix 5 of the Master Protocol during the treatment period and for at least 120 days after the last dose of study treatment.<br>5. Women who are lactating who agree not to breastfeed their child during the study and for at least 120 days after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded).<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 900<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number | Exclusion criteria: <br>Patients are excluded from the study if any of the following criteria apply (or any of the criteria from the appropriate sub-protocol):<br>1. Patients who have previously had a score of 6 or 7 on the 9-point ordinal scale.<br>2. Any patient whose interests are not best served by study participation, as determined by a senior attending clinician.<br>3. Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >5 × the upper limit of normal (ULN).<br>4. Known active infection with HIV or hepatitis B or C.<br>5. Stage 4 severe chronic kidney disease.<br>6. Allergy to any study medication.<br>7. Experimental off-label usage of medicinal products as treatments for COVID-19 (except where the product has either been given a positive opinion under the Early Access to Medicines Scheme [EAMS] or is a SARS-CoV-2 vaccine) at the time of enrolment.<br>8. Patients participating in another clinical study of an investigational medicinal product, unless co-enrolment in the other study has been pre-approved by the Sponsor and Chief Investigator.<br>9. Active tuberculosis defined as requiring current treatment for tuberculosis.<br><br>Additional exclusion criteria that are specific to the sub-protocol ACCORD-2-002:<br>X1. Inability to swallow capsules (administration via nasogastric tube is permitted in patients who become unable to swallow after starting the study drug)<br>X2. Patients with a permanent cardiac pacemaker implanted.<br>X3. History of the following cardiac conditions:<br>a) Myocardial infarction within 3 months prior to the first dose <br>b) Unstable angina<br>c) History of clinically significant dysrhythmias (long QT features on ECG, sustained bradycardia [=55 bpm]), left bundle branch block, or ventricular arrhythmia) or history of familial long QT.<br>Patients with an implantable cardioverter defibrillator device in place, will be allowed to enrol. Atrial fibrillation will not be a reason for exclusion.<br>X4. Screening 12-lead ECG with a measurable QTc interval according to Fridericia correction (QTcF) >470 msec<br>In the presence of a temporary cardiac pacemaker, QTcF will need to be calculated from an ECG which has been recorded during a period where ventricular (QRS) complexes without pacing are present. If no unpaced ventricular complexes are present to allow calculation of QTcF, the patient should not be enrolled in this sub-protocol.<br>X5. Clinically significant hypokalaemia. Individuals who do not meet this criterion may be rescreened once, after correction of electrolyte abnormality<br>X6. Therapeutic anticoagulation with vitamin K antagonists. Note: Patients receiving low doses prescribed to maintain the patency of venous access devices may be included.<br>X7. Previous bowel resection that would interfere with drug absorption<br><br><br>Additional exclusion criteria that are specific to the sub-protocol ACCORD-2-003:<br>X1. A known history of myocardial infarction within 3 months prior to the first dose <br>X2. A known history of heart failure defined as either of the following:<br>a) =2 first degree relatives with clinically significant heart failure, or<br>b) =1 first degree relative with heart failure known to be heritable (eg, hypertrophic cardiomyopathy), unless inheritance was previously excluded by genetic testing<br><br>Additional exclusion criteria that are specific to the sub-protocol ACCORD-2-006:<br><br>X1.Participants with unresolved or suspected infection with Neisseria meningitidis, or a past history of Neisseria meningitidis (eg, in a complement deficient patient), should not receive treatment with ziluc | COVID 19 <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Bemcentinib<br>Product Code: BGB324<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: bemcentinib<br>CAS Number: 1037624-75-1<br>Current Sponsor code: BGB324<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br>Product Name: MEDI3506<br>Product Code: MEDI3506<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: N/A<br>CAS Number: 2376858-66-9<br>Current Sponsor code: MEDI3506<br>Other descriptive name: human immunoglobulin (Ig) G1 monoclonal antibody (mAb)<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 150-<br><br>Product Name: Zilucoplan<br>Pharmaceutical Form: Solution for injection in pre-filled syringe<br>INN or Proposed INN: Zilucoplan<br>CAS Number: 1841136-73-9<br>Current Sponsor code: RA101495<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 40-<br><br>Product Name: acalabrutinib<br>Product Code: ACP-196<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: acalabrutinib<br>CAS Number: 1420477-60-6<br>Current Sponsor code: ACP-196<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br> | Timepoint(s) of evaluation of this end point: As defined in Main protocol<br><br>Sub-protocol-ACCORD-2-003:<br>Day 29<br>;Primary end point(s): •Time to sustained clinical improvement of at least 2 points (from randomisation) on a 9 point category ordinal scale, live discharge from the hospital, or considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale), whichever comes first, by Day 29 (this will also define the “responder” for the response rate analyses).<br><br>9-point category ordinal scale:<br>0. Uninfected, no clinical or virological evidence of infection<br>1. Ambulatory, no limitation of activities<br>2. Ambulatory, limitation of activities<br>3. Hospitalised – mild disease, no oxygen therapy<br>4. Hospitalised – mild disease, oxygen by mask or nasal prongs<br>5. Hospitalised – severe disease, noninvasive ventilation or high flow oxygen<br>6. Hospitalised – severe disease, intubation and mechanical ventilation<br>7. Hospitalised – severe disease, ventilation and additional organ support – vasopressors, renal replacement therapy (RRT), extracorporeal membrane oxygenation (ECMO)<br>8. Death<br>***************<br>Sub-protocol-ACCORD-2-002, 003 & 006: As defined in Master Protocol.;Secondary Objective: Secondary<br>• To evaluate the ability to prevent deterioration according to the ordinal scale by 1, 2, or 3 points<br>• To evaluate the number of oxygen free days.<br>• To evaluate ventilator-free days and incidence and duration of any form of new ventilation use.<br>• To evaluate duration of organ support (eg, including respiratory, renal, and cardiac support).<br>• To evaluate response rate. (see primary endpoint for definition of responder).<br>• To evaluate time to discharge.<br>• To evaluate overall mortality.<br>• Change in the ratio of the oxygen saturation to fraction of inspired oxygen concentration (SpO2/FiO2),<br>• To evaluate the safety of candidate agents as add on therapy to SoC in patients with COVID-19.<br>• To evaluate intensive care unit (ICU) and hospitalisation length.<br>• To evaluate National Early Warning Score 2 (NEWS2).<br>***********<br>Additional sub protocol(ACCORD-2-002) secondary objectives<br>• To evaluate the ability to prevent deterioration according to the ordinal scale by 1, 2, or 3 points<br>•;Main Objective: •Stage 1: To evaluate the efficacy of candidate agents as add on therapies to Standard of Care (SoC) in patients hospitalised with COVID 19 in a screening stage.<br><br>•Stage 2: To confirm the efficacy of identified efficacious candidate agents in patients hospitalised with COVID 19 in an expansion stage.<br> | | | | Yes | True | parent | |
| → | EUCTR2020-001072-15-GB | 16 November 2020 | A phase I/II to determine efficacy, safety and immunogenicity of a candidate COVID-19 vaccine | A phase I/II study to determine efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 in UK healthy adult volunteers - A phase I/II trial of a candidate COVID-19 vaccine (COV001) | | University of Oxford | 19/03/2020 | 20200319 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001072-15 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 26/03/2020 | 1112 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: yes
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 4
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United Kingdom | Andrew Pollard | | CCVTM, Churchill Hospital | andrew.pollard@paediatrics.ox.ac.uk | 01865611400 | University of Oxford | Inclusion criteria: <br>• Healthy adults aged 18-55 years. <br>• Able and willing (in the Investigator’s opinion) to comply with all study requirements (participants must not rely on public transport or taxis).<br>• Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures.<br>• For females only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination.<br>• Agreement to refrain from blood donation during the course of the study.<br>• Provide written informed consent.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 1112<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range 0<br> | Exclusion criteria: <br>• Prior receipt of any vaccines (licensed or investigational) =30 days before enrolment <br>• Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination with the exception of the licensed seasonal influenza vaccination and the licensed pneumococcal vaccine. Participants will be encouraged to receive these vaccinations at least 7 days before or after their study vaccine.<br>• Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines).<br>• Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.<br>• Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting <14 days) .<br>• Any autoimmune conditions, except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy. <br>• History of allergic disease or reactions likely to be exacerbated by any component of the ChAdOx1 nCoV-19 or MenACWY vaccines. <br>• Any history of angioedema .<br>• Any history of anaphylaxis .<br>• Pregnancy, lactation or willingness/intention to become pregnant during the study.<br>• History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).<br>• History of serious psychiatric condition likely to affect participation in the study (e.g. ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication). <br>• Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.<br>• Any other serious chronic illness requiring hospital specialist supervision.<br>• Chronic respiratory diseases, including mild asthma (resolved childhood asthma is allowed)<br>• Chronic cardiovascular disease (including hypertension), gastrointestinal disease, liver disease (except Gilberts Syndrome), renal disease, endocrine disorder (including diabetes) and neurological illness (excluding migraine)<br>• Seriously overweight (BMI=40 Kg/m2) or underweight (BMI=18 Kg/m2)<br>• Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week.<br>• Suspected or known injecting drug abuse in the 5 years preceding enrolment.<br>• Any clinically significant abnormal finding on screening biochemistry, haematology blood tests or urinalysis. <br>• Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.<br>• History of laboratory confirmed COVID-19.<br>• New onset of fever or a cough or shortness of breath or anosmia/ageusia since February 2020. Should a reliable test become available, this exclusion criteria will be replaced with seropositivity for SARS-CoV-2 before enrolment. <br>• Those who have been a | COVID-19 <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: ChAdOx1 nCoV-19<br>Pharmaceutical Form: Solution for injection<br>Pharmaceutical form of the placebo: Powder and solvent for solution for injection<br>Route of administration of the placebo: Intramuscular use<br><br>Trade Name: Nimenrix<br>Product Name: Nimenrix<br>Pharmaceutical Form: Powder and solvent for solution for injection<br><br>Trade Name: Menveo<br>Product Name: Menveo<br>Pharmaceutical Form: Powder and solvent for solution for injection<br><br> | Main Objective: To assess efficacy of ChAdOx1 nCoV-19 against COVID-19<br><br>To assess the safety of the candidate vaccine ChAdOx1 nCoV;Secondary Objective: To assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV<br>To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19<br>To assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19<br>Exploratory Immunology<br>To assess immunogenicity of ChAdOx1 nCoV-19 given as homologous prime-boost<br>To compare viral shedding on stool samples of SARS-CoV-2 PCR or other nucleic acid amplification test (NAAT) positive individuals;Primary end point(s): To assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19:<br>a) Virologically confirmed (PCR or other NAAT positive result) symptomatic cases of COVID-19<br><br>To assess the safety of the candidate vaccine ChAdOx1 nCoV:<br>a)Occurrence of serious adverse events (SAEs) throughout the study duration;Timepoint(s) of evaluation of this end point: Throughout the study duration→Timepoint(s) of evaluation of this end point: Throughout the study duration;Primary end point(s): To assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19:<br>a) Virologically confirmed (PCR or other NAAT positive result) symptomatic cases of COVID-19<br><br>To assess the safety of the candidate vaccine ChAdOx1 nCoV:<br>a)Occurrence of serious adverse events (SAEs) throughout the study duration;Secondary Objective: To assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV<br>To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19<br>To assess cellular and humoral immunogenicity of ChAdOx1 nCoV-19<br>Exploratory Immunology<br>To assess immunogenicity of ChAdOx1 nCoV-19 given as homologous prime-boost<br>To compare viral shedding on stool samples of SARS-CoV-2 PCR or other nucleic acid amplification test (NAAT) positive individuals;Main Objective: To assess efficacy of ChAdOx1 nCoV-19 against COVID-19<br><br>To assess the safety of the candidate vaccine ChAdOx1 nCoV | | | | Yes | True | child | |
| ACTRN12620000554965 | 24 November 2020 | ADAPT - COVID-19 Study - A prospective, observational cohort study at St Vincent’s Hospital Sydney | ADAPT - COVID-19 Study - Characterising pathophysiological, immunological and clinical outcomes relating to COVID-19 infection in the patient population of St Vincent’s Hospital Sydney. | | St Vincent's Health Network | 11/05/2020 | 20200511 | ANZCTR | https://anzctr.org.au/ACTRN12620000554965.aspx | Recruiting | No | 18 Years | No limit | Both males and females | 14/05/2020 | 300 | Observational | Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Both; | Not Applicable | Australia | | | | | | | Inclusion criteria: 1. Age greater than or equal to 18 years
<br>2. Confirmed SARS-CoV-2 by nucleic acid testing
<br>3. Able to provide informed consent
<br> | Exclusion criteria: 1. Unable or unwilling to provide consent
<br>2. Death is deemed to be imminent and inevitable within the next 24 hours
<br>3. Pregnancy (Cohort B only)
<br> | COVID-19; <br>COVID-19;Infection - Other infectious diseases;Respiratory - Other respiratory disorders / diseases;Public Health - Epidemiology | This is a prospective, observational cohort study of all patients at St Vincent’s Hospital Sydney who test positive for COVID-19 infection. The cohort will consist of two components.<br>Cohort A - Mild disease patients recruited through the community cohorts<br>Cohort B - Moderate-severe patients recruited through the inpatient service at St Vincent’s Hospital Sydney. <br>Each patient shall be followed for a period of 12 months from the time of COVID-19 diagnosis. The study will run for 2 years in total. <br>The study will examine the short, medium and long term effects of COVID-19 on the immune system. The study will also examine how the immune system responds to COVID-19 to form antibodies and the long-term effects of COVID-19 on heart, lung and brain function and also a person’s mental health and effect on a person’s activities of daily living. | Primary outcome is the evolution of an immunological response to COVID-19 measured by COVID-19 antibody formation. [ 1, 4 and 12 months post COVID-19 diagnosis] | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-001467-82-NL | 23 November 2020 | Investigation of the antiviral effect of Voclosporine on COVID-19 in renal transplant patients | An Open-Label Study Evaluating Anti-Viral Effects of Voclosporin in SARS-CoV-2 Positive Kidney Transplant Recipients – the VOCOVID Study (COVID-19) - The VOCOVID Study | | Leiden University Medical Center | 28/04/2020 | 20200428 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001467-82 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 23/10/2020 | 30 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Netherlands | Dr. Y.K.O. Teng | | Albinusdreef 2 | y.k.o.teng@lumc.nl | 0031715262148 | Leiden University Medical Center | Inclusion criteria: <br>1. Provide written informed consent, in accordance with EMA guidance on the management of clinical trials during COVID-19 pandemic (Version 2, 27 March 2020). If written consent by the trial participant is not possible (for example because of physical isolation due to COVID-19 infection), consent could be given orally by the trial participant (Art 2(j) of Directive 2001/20/EC) in the presence of an impartial witness. In such cases, the witness is required to sign and date the informed consent document and the Investigator is expected to record how the impartial witness was selected.<br>2. Male or female subjects with a minimum age of 18 years (or legal age of consent if <18 years) at Visit 1.<br>3. Subjects with a stable kidney transplant taking TAC and a confirmed diagnosis of SARS-CoV-2 by nuclear acid testing, with mild-to-moderate symptoms.<br>4. Women of childbearing potential must have a negative pregnancy test at baseline. Two effective forms of contraception must be used simultaneously unless abstinence is the chosen method. Subjects must use effective contraception during the study.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 10<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 20<br> | Exclusion criteria: <br>1. Subjects unable or unwilling to give written informed consent and/or to comply with study procedures.<br>2. Any known hypersensitivity or contraindication to CNIs, especially CsA, or components of any cyclosporine drug product.<br>3. Current or medical history of:<br>• Congenital immunodeficiency.<br>• Severe, known, active viral infections, excluding SARS-CoV-2, within 3 months of baseline (e.g., cytomegalovirus, hepatitis B virus, hepatitis C virus or HIV) that are deemed to interfere with study assessments or outcome according to Investigator’s judgement.<br>4. Severe symptoms resulting from SARS-CoV-2 infection requiring positive pressure ventilation at baseline.<br>5. Other major physical or psychiatric illness or major traumatic injury or any other medical condition associated with increased risk to the subject or that may affect study conduct or interfere with study assessments or outcome according to Investigator’s judgement.<br>6. Subjects who are pregnant, breast feeding or, if of childbearing potential, not using adequate contraceptive precautions.<br>7. Participation in another interventional clinical study within 4 weeks prior to baseline and/or receipt of investigational drugs within 4 weeks or 5 half-lives of the drug (whichever is longer) prior to baseline.<br>8. Subjects less than 3 months post-transplant.<br>9. Subjects with documented organ rejection within the past 3 months.<br>10. Subjects with a documented estimated glomerular filtration rate (eGFR) <15 ml/min within the previous 3 months prior to screening.<br> | SARS-CoV-2 infection in Kidney Transplant Recipients <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
<br>MedDRA version: 21.1
Level: LLT
Classification code 10052212
Term: Organ transplant NOS
System Organ Class: 100000004865
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Voclosporin or Lupkynis<br>Pharmaceutical Form: Capsule, soft<br>INN or Proposed INN: Voclosporin<br>CAS Number: 515814-01-4<br>Current Sponsor code: ISA247<br>Other descriptive name: VOCLOSPORIN<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 7.9-<br><br> | Timepoint(s) of evaluation of this end point: 28 days;Primary end point(s): The main endpoint is the reduction in SARS-CoV-2 viral load over 28 days, as measured by quantitative reverse transcription polymerase chain reaction (RT-qPCR). ;Secondary Objective: To assess the safety and tolerability of voclosporine in stable Kidney Transplant Recipients infected with SARS-CoV-2;Main Objective: To investigate the anti-viral effects of voclosporin compared to standard of care with tacrolimus on SARS-CoV-2 over 28 days in stable Kidney Transplant Recipients | | | | Yes | False | | |
| → | EUCTR2020-004743-83-GB | 23 November 2020 | A trial of an inhaled antiviral drug to treat or prevent severe respiratory difficulties in patients hospitalised with moderate COVID-19 | A randomised, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalised due to moderate COVID-19 - Phase III trial of inhaled anti-viral (SNG001) for SARS-CoV-2 | | Synairgen Research Limited | 26/10/2020 | 20201026 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004743-83 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 09/11/2020 | 900 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 3<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Romania;Germany;Poland;Belgium;Brazil;Argentina;Canada;Mexico;United Kingdom;Turkey;Moldova, Republic of;Netherlands;South Africa;Peru;France;India;Italy;Colombia;Russian Federation;Chile;Israel;Ukraine;Spain;Serbia;Portugal;United States→Romania;Germany;Poland;Colombia;Russian Federation;Chile;Israel;Ukraine;Spain;Serbia;Portugal;United States;Belgium;Brazil;Argentina;Canada;Mexico;United Kingdom;Turkey;Moldova, Republic of;Netherlands;South Africa;Peru;France;India;Italy | Sophie Hemmings | | Mail Point 810, Level F, Southampton General Hospital | Sophie.Hemmings@synairgen.com | 02380512800 | Synairgen Research Ltd | Inclusion criteria: <br>1. Male or female, =18 years of age at the time of consent.<br>2. Admitted to hospital due to the severity of their COVID-19.<br>3. Positive virus test for SARS-CoV-2 using a validated molecular assay (e.g. RT-PCR). Patients who had positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test was performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection.<br>4. Require oxygen therapy via nasal prongs or mask (OSCI score of 4).<br>5. Provide informed consent.<br>6. Female patients must be =1 year post-menopausal, surgically sterile, or using a highly effective method of contraception. Acceptable highly effective methods of contraception include;<br>• bilateral tubal occlusion<br>• intrauterine device (provided coils are copper-banded)<br>• levonorgestrel intrauterine system (e.g., Mirena™)<br>• medroxyprogesterone injections (e.g., Depo-Provera™)<br>• etonogestrel implants (e.g., Implanon™, Norplan™)<br>• normal and low dose combined oral pills<br>• norelgestromin/ ethinylestradiol transdermal system<br>• intravaginal device (e.g., ethinylestradiol and etonogestrel), desogestrel (e.g., Cerazette™)<br>• total sexual abstinence (defined as refraining from heterosexual intercourse)<br>• vasectomised sexual partner.<br>Women should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled IFN-ß1a/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in UK with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-ß1a/matching placebo to prevent pregnancy.<br>7. Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal<br>if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply:<br>• Women <50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the<br>postmenopausal range.<br>• Women =50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.<br><br>If, in the setting of the pandemic, the use of an acceptable birth control method is not possible, the decision to enrol a woman of childbearing potential should be based on the benefit-risk for the patient, which should be discussed with the patient at the time of the informed consent.<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 450<br>F.1.3 Elderly (>=65 years) yes<br>F.1. | Exclusion criteria: <br>1. Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay e.g. RT-PCR test.<br>2. Mechanical ventilation (continuous or intermittent CPAP or intubation) or admission to intensive care.<br>3. Previous SARS-CoV-2 infection confirmed by a validated molecular assay e.g. RT-PCR test.<br>4. Any condition, including findings in the patient’s medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study<br>or that could interfere with the study objectives, conduct or evaluation.<br>5. Participation in previous clinical trials of SNG001.<br>6. Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product (IMP) containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry<br>into this study or containing biologicals within 3 months prior to entry into this study.<br>7. Inability to use a nebuliser with a mouthpiece.<br>8. Inability to comply with the requirements for storage conditions of study medication in the home setting.<br>9. History of hypersensitivity to natural or recombinant IFN-ß or to any of the excipients in the drug preparation.<br>10. Females who are breast-feeding, lactating, pregnant or intending to become pregnant<br> | COVID-19 <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Interferon beta-1a (IFN-ß1a) <br>Product Code: SNG001<br>Pharmaceutical Form: Inhalation solution<br>INN or Proposed INN: Interferon beta-1a<br>Current Sponsor code: SNG001<br>Concentration unit: million IU million international units<br>Concentration type: equal<br>Concentration number: 12 -<br>Pharmaceutical form of the placebo: Nebuliser solution<br>Route of administration of the placebo: Inhalation use<br><br> | Timepoint(s) of evaluation of this end point: OSCI assessments will be conducted daily between day 1 and day 35. Time to recovery will be assessed over the first 28 days of the study period. The OSCI assessments after day 28 will be used to assess relapse only. ;Primary end point(s): Time to recovery, where recovery is defined as the OSCI score of 1 or below, with no rebound at subsequent assessments.<br>;Secondary Objective: To evaluate the efficacy of SNG001 compared to placebo in patients with moderate COVID-19, using a range of endpoints.<br><br>To assess the general safety and tolerability of SNG001 compared to placebo when administered to patients with moderate COVID-19.<br>;Main Objective: To evaluate recovery in patients with moderate COVID-19 after administration of SNG001 compared to placebo.<br> | | | | Yes | False | | |
| EUCTR2020-001396-33-GB | 23 November 2020 | EPA-FFA to treat hospitalised patients with SARS-CoV-2 | A randomised, double-blind, placebo-controlled study of eicosapentaenoic acid (EPA-FFA) gastro-resistant capsules to treat hospitalised subjects with confirmed SARS-CoV-2 | | SLA Pharma (UK) Ltd | 09/04/2020 | 20200409 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001396-33 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 13/11/2020 | 284 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| United Kingdom;Israel;South Africa;Ireland;Spain;France;United States | Clinical Operations | | Building 5, Leavesden Park, Hercules Way | jslagel@slapharma.com | +441923681001 | SLA Pharma (UK) Ltd | Inclusion criteria: <br>1. Male or female, aged 18 years and above.<br>2. Provided informed consent prior to any study specific procedure being conducted.<br>3. Positive local approved test to confirm diagnosis of SARS-CoV-2, within 7 days prior to baseline.<br>4. Classified as moderate or severe based on the modified WHO/NIH baseline severity criteria.<br>Moderate: evidence of lower respiratory disease by clinical assessment (eg signs or symptoms of lung infection) or by chest X-ray/CT/ultrasound imaging (e.g. viral pneumonia, lung infiltrates) and a saturation of oxygen (SaO2) = 94% on room air at sea level.<br>Severe: respiratory frequency >30 bpm, SaO2 < 94% on room air at sea level, ratio of arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) < 300 mmHg, or lung infiltrates >50%.<br>5. Hospitalised or attended the hospital ED due to clinical and/or virological diagnosis of SARS-CoV-2; subsequent follow up after screening may be carried out in hospital (hospitalised) or at a COVID-19 hospital OP clinic as clinically indicated at the investigator’s discretion. Where it is not possible for the subject to attend a hospital OP clinic, then providing a suitably trained healthcare professional (eg part of the clinical research team) as directed by the investigator, is available to visit the subject at home to conduct the necessary clinical and SaO2 assessments and blood tests, subsequent assessments post-hospitalisation or ED visit may be conducted at the subject’s home.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 234<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 50<br> | Exclusion criteria: <br>1. No symptoms or signs or lung imaging abnormalities of SARS-CoV-2.<br>2. On or clinically diagnosed as requiring intubation at screening.<br>3. On or clinically diagnosed as requiring mechanical ventilation at screening. <br>4. On or clinically diagnosed as requiring oxygen delivered by high flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates > 20 L/min with fraction of delivered oxygen =0.5).<br>5. On or clinically diagnosed as requiring noninvasive positive pressure ventilation.<br>6. On or clinically diagnosed as requiring extracorporeal membrane oxygenation (ECMO).<br>7. Subjects who are unable to swallow study capsules easily. <br>8. Known allergic reaction or intolerant to fish or fish oils.<br>9. Known allergic reaction to excipients of IMP.<br>10. Subjects who are pregnant or breast-feeding at screening.<br>11. Taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study.<br>12. Taking immunomodulators/immunosuppressants, including corticosteroids on entry to the study<br>13. Used another investigational drug in the past 48 hours or 5 half-lives, whichever is longer, prior to Screening.<br>14. Participating in other clinical studies at the same time.<br>15. Evidence of multi-organ failure, SOFA score >9<br>16. Deemed, by the investigator, unlikely to be able to comply with the requirements of the protocol.<br>17. Deemed, by the investigator, likely to require transfer to the intensive care unit (ICU) or unlikely to survive for at least 48 hours.<br>18. Any gastro-intestinal symptoms at screening considered clinically<br>significant.<br>19. Clinically significant abnormalities, which in the opinion of the investigator would significantly risk the safety of the subject or the main objectives of the study.<br><br> | SARS-CoV-2 <br>MedDRA version: 23.0
Level: LLT
Classification code 10084272
Term: SARS-CoV-2 infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: EPA-FFA gastro-resistant capsules<br>Product Code: EPA-FFA<br>Pharmaceutical Form: Gastro-resistant capsule, soft<br>INN or Proposed INN: Icosapent<br>CAS Number: 25378-27-2<br>Other descriptive name: Eicosapentaenoic acid<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 500-<br>Pharmaceutical form of the placebo: Gastro-resistant capsule, soft<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: 4 weeks;Primary end point(s): Proportion of subjects alive and free of respiratory failure at 28 days. Respiratory failure will be defined as at least one of the following:<br>1. Endotracheal intubation and mechanical ventilation.<br>2. Oxygen delivered by high-flow nasal cannula.<br>3. Non-invasive positive pressure ventilation or continuous positive airway pressure (CPAP).<br>4. Extracorporeal membrane oxygenation (ECMO).;Secondary Objective: To determine whether EPA-FFA gastro-resistant capsules: <br>- decreases the time to and amount of clinical improvement as determined by the WHO 9-point ordinal scale.<br>- increases the number of subjects alive and discharged home without supplemental oxygen therapy.<br>- decreases IL-6 during the study.<br>- decreases CRP during the study.<br>- increases IFN-? during the study.<br>- decreases other pro-inflammatory chemokines and cytokines. <br><br>Safety objectives:<br>- to evaluate the safety of EPA-FFA gastro-resistant capsules in the treatment of SARS-CoV-2.;Main Objective: The primary objective is to evaluate the efficacy of EPA-FFA gastro-resistant capsules compared to placebo, with respect to disease progression in subjects with a confirmed diagnosis of SARS-CoV-2. | | | | Yes | False | | |
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| EUCTR2020-001553-48-FR | 30 November 2020 | Corticoïdes au cours de la pneumonie virale Covid-19 liée à l’infection par le SARS-Cov-2 | Corticoïdes au cours de la pneumonie virale Covid-19 liée à l’infection par le SARS-Cov-2 - CORTI-Covid | | Hospices Civils de Lyon | 03/04/2020 | 20200403 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001553-48 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 13/04/2020 | 304 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: current practice
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| France | Regulatory Project Manager | | 3 QUAI DES CELESTINS | drci_promo@chu-lyon.fr | 472406829+33 | Hospices Civils de Lyon | Inclusion criteria: <br>- Age = 18 ans, <br>- Hospitalisation pour infection COVID-19 confirmée par RT-PCR ou autre méthode virologique,<br>- Saturation périphérique par oxymètre de pouls SpO2 = 94% en air ambiant mesurée à deux reprises à 5-15 min d’intervalle, ou PaO2/FiO2 <300 mmHg,<br>- Anomalies sur la radiographie ou le scanner thoracique évoquant une pneumopathie virale,<br>- Signature d’un consentement libre et éclairé par le patient <br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 79<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range 225<br> | Exclusion criteria: <br>- Infection Covid-19 avec premiers symptômes datant de plus de 9 jours selon l’interrogatoire du patient ; le J1 des symptômes est défini par le premier jour avec fièvre, toux, essoufflement, et/ou frissons reliés à l’infection Covid-19 ;<br>- Patients avec déficit immunitaire primitif ou secondaire, dont : HIV, maladie hématologique chronique, greffe d’organe solide, traitement immunosuppresseur en cours,<br>- Corticothérapie au long cours définie par une prise de plus de 10 mg/j (équivalent prednisone),<br>- Infection suspectée ou confirmée en cours à bactérie, agent fongique, ou virus (en plus de Covid-19),<br>- Contre-indication connue aux corticoïdes par voie générale,<br>- Pression artérielle systolique < 80 mmHg,<br>- SpO2 < 90% sous 5 L/min d’oxygène au masque à moyenne concentration, ou besoins supérieurs en oxygène,<br>- Patient sous oxygénothérapie de longue durée,<br>- Ventilation mécanique en cours,<br>- Choc septique en cours,<br>- Défaillance multiviscérale en cours,<br>- Femme enceinte ou allaitante (diagnostic oral),<br>- Absence d’affiliation ou ayant-droit d’un régime de Sécurité Sociale, <br>- Tutelle, curatelle ou sauvegarde de justice.<br><br> | viral pneumonia <br>MedDRA version: 20.1
Level: LLT
Classification code 10047474
Term: Viral pneumonia
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Trade Name: prednisone<br>Product Name: prednisone<br>Pharmaceutical Form: Capsule<br>INN or Proposed INN: PREDNISONE<br>Concentration unit: mg/kg milligram(s)/kilogram<br>Concentration type: equal<br>Concentration number: 0.75-<br><br> | Timepoint(s) of evaluation of this end point: J14 des symptômes ±5 jours;Primary end point(s): Nombre de patients à J7 de la randomisation (soit J14 des symptômes ±5 jours), présentant une indication théorique de transfert en réanimation d’indication respiratoire évaluée par une SpO2 < 90% stabilisée au repos et sous 5 L/min d’oxygène au masque à moyenne concentration mesurée deux fois à 5-15 min d’intervalle. La valeur moyenne des deux mesures sera retenue.;Secondary Objective: Evalués à la visite 3, J7 de la randomisation (soit J14 des symptômes ±2jours) : <br>- Réduire la gravité sur une échelle ordinale à 7 niveaux <br>- Réduire les besoins en oxygénothérapie<br>- Réduire les signes radiologiques visibles sur l’imagerie thoracique<br><br>Evalués à la visite 4, J21 de la randomisation (soit J28 des symptômes ±2jours) : <br>- Réduire le nombre de patients transférés en réanimation ou soins intensifs<br>- Réduire le nombre de patients nécessitant un recours à la ventilation invasive<br>- Réduire la durée de l’oxygénothérapie<br>- Réduire la durée d’hospitalisation à partir de la randomisation<br>- Evaluer la tolérance de la corticothérapie et la fréquence des complications induites par la corticothérapie<br>- Evaluer la fréquence des infections autres que SARS-CoV-2<br>- Evaluer la mortalité globale à J21 (J28 des symptômes)<br>;Main Objective: Réduire le nombre de patients présentant une indication théorique de transfert en réanimation d’indication respiratoire, évaluée par une SpO2 < 90% stabilisée au repos et sous un débit d’oxygène ne dépassant pas 5 L/min d’oxygène au masque à moyenne concentration à J7 de la randomisation (soit J14 des symptômes ±5 jours). Ce critère permet de déterminer objectivement la gravité de l’état respiratoire du patient. | | | | Yes | True | parent | |
| → | EUCTR2020-001357-52-ES | 30 November 2020 | Effect of the administration of Hydroxychloroquine as prevention of COVID-19 infection in patients with biological treatment or with JAK inhibitors | Randomized, Controlled, Double-blind Clinical Trial Comparing the Efficacy
and Safety of Chemoprophylaxis With Hydroxychloroquine in Patients Under
Biological Treatment and / or JAK Inhibitors in the Prevention of SARS-CoV-2
Infection. COVID-19 | | IDIVAL | 14/05/2020 | 20200514 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001357-52 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 13/05/2020 | 800 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Spain | Mar García Saiz | | Avenida de Valdecilla s/n | mmar.garcia@scsalud.es | 3494220 33 33 | IDIVAL | Inclusion criteria: <br>1) Patients between 18 and 75 years old at baseline<br>2) Subjects must be able and willing to give written informed consent<br>and to comply with the requirements of this study protocol<br>3) Patient in treatment with biological agents in a stable way, for a minimum period of 6 months, including treatment with Infliximab, etanercept, adalimumab, certolizumab, golimumab, rituximab, abatacept, tocilizumab, sarilumab, secukinumab, vedolizumab, natalizumab, ustekinumab, tofacitinib, baricitinib.<br>4) Diagnosis of inflammatory bowel disease, rheumatoid arthritis, seronegative spondyloarthritis or psoriasis for more than 6 months.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 600<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 200<br> | Exclusion criteria: <br>1) Previous infection with SARS-CoV-2.<br>2) Current treatment with hydroxychloroquine / chloroquine.<br>3) Previous or current treatment with tamoxifen or raloxifene.<br>4) Previous eye disease, especially maculopathy.<br>5) Known heart failure grade III-IV of the classification of the New York Heart Association).<br>6) Any type of cancer (except basal cell) in the last 5 years.<br>7) Pregnancy.<br>8) Refusal to give informed consent.<br>9) Evidence of any other unstable or clinically significant untreated immunological, endocrine, hematological, gastrointestinal, neurological, neoplastic or psychiatric illness.<br>10) Instability or mental incompetence, so that the validity of the informed consent or the ability to complete the study is uncertain.<br>11) Positive antibodies to the human immunodeficiency virus.<br>12) Data on decompensated liver disease:<br>to. Aspartate aminotransferase (AST) and / or ALT> 10 x upper limit of normal (LSN).<br>b. Total bilirubin> 25 µmol / l (1.5 mg / dl).<br>c. International normalized index> 1.4.<br>d. Platelet count <100,000 / mm3.<br>13) Serum creatinine levels> 135 µmol / l (> 1.53 mg / dl) in men and> 110 µmol / l (> 1.24 mg / dl) in women.<br>14) Significant kidney disease, including nephrotic syndrome, chronic kidney disease (patients with markers of liver injury or estimated glomerular filtration rate [eGFR] of less than 60 ml / min / 1.73 m2). If an abnormal value is obtained at the first screening visit, the eGFR measurement may be repeated before randomization within the following time frame: minimum 4 weeks after the initial test and maximum 2 weeks before the planned randomization. Repeated abnormal eGFR (less than 60 ml / min / 1.73 m2) leads to exclusion from the study.<br> | Quimioprophylaxis of SARS-CoV-2 infection with hydroxyloquine (HCQ) in patients diagnosed with an immunomediated inflammatory disease who are following a treatment with biological agents and / or Jak inhibitor <br>MedDRA version: 20.0
Level: HLT
Classification code 10021982
Term: Inflammatory disorders following infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: hydroxychloroquine<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Hydroxychloroquine<br>CAS Number: 118-42-3<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: 6 month;Primary end point(s): Number of patients with serology and positive polymerase chain reaction for SARS-CoV-2 during the study<br>Assessment of the severity of the infectious picture:<br>- Presence of pneumonia<br>- qSOFA scale (Quick Sequential Organ Failure Assessment)<br>- CURB-65 scale<br>- Evolution to acute respiratory distress syndrome (ARDS)<br>- Need for mechanical ventilation;Secondary Objective: a) Evaluate the safety of hydroxychloroquine for 6 months in patients with immunoded diseases under biological treatment and / or Jak inhibitors.<br><br>b) Investigate the incidence, prevalence and severity of SARS CoV-2 infection in this group of patients in patients with immunoded diseases under biological treatment and / or Jak inhibitors.;Main Objective: Evaluate the efficacy of Hydroxychloroquine prophylaxis for 6 months versus placebo in preventing SARS-CoV-2 infection in patients with an immune-mediated inflammatory disease treated with biological agents and / or Jak inhibitors.→Main Objective: Evaluate the efficacy of Hydroxychloroquine prophylaxis for 6 months versus placebo in preventing SARS-CoV-2 infection in patients with an immune-mediated inflammatory disease treated with biological agents and / or Jak inhibitors.;Secondary Objective: a) Evaluate the safety of hydroxychloroquine for 6 months in patients with immunoded diseases under biological treatment and / or Jak inhibitors.<br><br>b) Investigate the incidence, prevalence and severity of SARS CoV-2 infection in this group of patients in patients with immunoded diseases under biological treatment and / or Jak inhibitors.;Primary end point(s): Number of patients with serology and positive polymerase chain reaction for SARS-CoV-2 during the study<br>Assessment of the severity of the infectious picture:<br>- Presence of pneumonia<br>- qSOFA scale (Quick Sequential Organ Failure Assessment)<br>- CURB-65 scale<br>- Evolution to acute respiratory distress syndrome (ARDS)<br>- Need for mechanical ventilation;Timepoint(s) of evaluation of this end point: 6 month | | | | No | False | | |
| EUCTR2020-001319-26-ES | 30 November 2020 | Clinical trial to assess the prognostic repercussions of rosuvastatin treatment in patients discharged after hospitalization for COVID-19 Positive. | Multicenter, randomized, controlled, open-label clinical trial to assess the prognostic implications of rosuvastatin treatment in patients discharged after hospitalization for COVID-19 Positive. - FJD-COVID-ESTATINAS | | Instituto de Investigación Sanitaria Fundación Jiménez Díaz | 14/05/2020 | 20200514 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001319-26 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 14/05/2020 | 1080 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Management according to usual clinical practice
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Spain | CLINICAL RESEARCH UNIT | | Avenida reyes católicos 2 | mireia.arcas@fjd.es | +00349155048003214 | FUNDACION JIMENEZ DIAZ HEALTH RESEARCH | Inclusion criteria: <br>1. Patients older than 45 years.<br>2. Diagnosed with a positive COVID 19 and having required hospital admission and discharges in the last 3 months, even if they tried to recruit as soon as possible from the time of discharge or just for a follow-up visit when they finished with the medications to the COVID or washout period after cyclosporine.<br>3. Acceptance and signing of the consent for the study after having received the appropriate information.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 1080<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 1080<br> | Exclusion criteria: <br>1. Chronic statin treatment at the time of hospitalization.<br>2. Known allergy or hypersensitivity to statins or any of their components,<br>3. History of statin intolerance due to increased transaminases, CPK or intolerable myalgias.<br>4. Severe renal failure: Estimated glomerular filtration <30mL / min / 1.73 m2 calculated by the CKD-EPI formula.<br>5. Survival <1 year for any known comorbidity<br>6. Previous liver or heart transplant<br>7. Patients with myopathy<br>8. Patients with concomitant treatment with cyclosporine<br>9. Liver dysfunction (ALT / AST or BT above 3 times the upper limit of normal)<br>10. Potentially fertile women who are unwilling to use an effective method of contraception.<br>11. Pregnancy or lactation<br>12. Participants in another clinical trial with medication in the 28 days prior to the start of recruitment. Simultaneous participation in observational studies is allowed.<br>13. At the investigator's discretion, the patient's inability to understand or comply with the study procedures<br>14. Refusal to participate<br> | COVID respiratory infection;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: ROSUVASTATIN<br>CAS Number: 287714-41-4<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 5-<br><br> | Main Objective: To determine if statin treatment has an impact on the poor prognosis (understood as death from any cause, myocardial infarction, ischemic stroke or admission due to heart failure) in the first year in patients discharged from hospital after admission for positive COVID19;Secondary Objective: To determine if statin treatment has an impact on the reduction of admissions for any cause, including hospitalizations for heart failure (these events will be studied in depth in case they could be the consequence of an acute coronary event and be part of the main objective) and pulmonary thromboembolism or deep vein thrombosis, in the first year in patients discharged from hospital after admission for positive COVID19.;Primary end point(s): Death of any cause, myocardial infarction or stroke.;Timepoint(s) of evaluation of this end point: 12 months | | | | Yes | False | | |
| → | EUCTR2020-001995-13-ES | 30 November 2020 | Clinical trial to evaluate the efficacy and safety of tocilizumab for treating patients with COVID-19 pneumonia: the BREATH-19 Study | A multicentre, open-label clinical trial to evaluate the effectiveness and safety of intravenous tocilizumab for treating patients with COVID-19 pneumonia: the BREATH-19 Study | | Fundación SEIMC-GESIDA | 21/05/2020 | 20200521 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001995-13 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 15/05/2020 | 500 | Interventional clinical trial of medicinal product | Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | Raúl Montalbán Casado | | C/Azcona, 31 | raul.m@dynasolutions.com | 003491 456 11 05 | Dynamic Science S.L. | Inclusion criteria: <br>- Provide oral informed consent to participate in this study.<br>- At least 18 years of age. <br>- Diagnosed with COVID-19 pneumonia by RT-PCR.<br>- Have received the first dose of tocilizumab a maximum of two days before the inclusion or is candidate for tocilizumab treatment.<br>- Hospitalized or admitted to ICU.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 500<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 500<br> | Exclusion criteria: <br>- The patient has any other medical condition or is receiving concomitant medication that could, in the opinion of the investigator, compromise the patient’s safety or collected data.<br>- Known severe allergic reactions to tocilizumab or other monoclonal antibodies.<br>- Active acute and severe infections, including tuberculosis infection.<br>- Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination<br> | COVID-19 pneumonia <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Roactemra<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: Tocilizumab<br>CAS Number: 375823-41-9<br>Other descriptive name: TOCILIZUMAB<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 20-<br><br> | Main Objective: To evaluate the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia. Improvement of respiratory function based on: <br>- Time to intubation (if not previously intubated) and duration of intubation.<br>- Time of non-invasive mechanical ventilation. <br>- Time of oxygen therapy.<br><br>Mortality rate;Timepoint(s) of evaluation of this end point: End points will be evaluated on a ongoing basis during the clinical trial;Primary end point(s): - Respiratory function, defined as:<br>Start date of intubation (in patients not previously initiated). <br>Date of extubation.<br>Start date of NIMV and date of independence from NIMV (duration of NIMV).<br>Start date of oxygen therapy and date of independence from oxygen therapy (duration of oxygen therapy).<br><br>- Mortality rate.;Secondary Objective: - To describe oxygen saturation (SpO2), PaO2/FiO2 (<300), or the equivalent SaO2/FiO2 (<315) <br>- To evaluate radiological evolution<br>- To describe the duration of hospitalization and/or ICU stay <br>- To evaluate the requirement of additional organ support, including kidney dialysis, molecular adsorbent recirculating system (MARS), extracorporeal membrane oxygenation (ECMO), or other<br>- To evaluate the effect of IV tocilizumab on the serum levels of inflammatory markers<br>- To describe safety of IV tocilizumab in patients with COVID-19 pneumonia<br>- To identify prognosis factors of IV tocilizumab effectiveness related to inflammatory markers and clinical/radiological features.<br>- To assess time to reverse-transcriptase polymerase chain reaction (RT-PCR) virus negativity, as appropriate.<br>- To compare the effectiveness and safety outcomes based on the different doses of IV tocilizumab used in the participating centres.<br>- To identify patient profile suitable to be benefited with tocilizumab→Timepoint(s) of evaluation of this end point: End points will be evaluated on a ongoing basis during the clinical trial;Primary end point(s): - Respiratory function, defined as:<br>Start date of intubation (in patients not previously initiated). <br>Date of extubation.<br>Start date of NIMV and date of independence from NIMV (duration of NIMV).<br>Start date of oxygen therapy and date of independence from oxygen therapy (duration of oxygen therapy).<br><br>- Mortality rate.;Secondary Objective: - To describe oxygen saturation (SpO2), PaO2/FiO2 (<300), or the equivalent SaO2/FiO2 (<315) <br>- To evaluate radiological evolution<br>- To describe the duration of hospitalization and/or ICU stay <br>- To evaluate the requirement of additional organ support, including kidney dialysis, molecular adsorbent recirculating system (MARS), extracorporeal membrane oxygenation (ECMO), or other<br>- To evaluate the effect of IV tocilizumab on the serum levels of inflammatory markers<br>- To describe safety of IV tocilizumab in patients with COVID-19 pneumonia<br>- To identify prognosis factors of IV tocilizumab effectiveness related to inflammatory markers and clinical/radiological features.<br>- To assess time to reverse-transcriptase polymerase chain reaction (RT-PCR) virus negativity, as appropriate.<br>- To compare the effectiveness and safety outcomes based on the different doses of IV tocilizumab used in the participating centres.<br>- To identify patient profile suitable to be benefited with tocilizumab;Main Objective: To evaluate the effectiveness of IV tocilizumab in treating patients with COVID-19 pneumonia. Improvement of respiratory function based on: <br>- Time to intubation (if not previously intubated) and duration of intubation.<br>- Time of non-invasive mechanical ventilation. <br>- Time of oxygen therapy.<br><br>Mortality rate | | | | No | False | | |
| EUCTR2020-002274-28-ES | 30 November 2020 | Evaluation of the likely beneficial effects of vitamin D on infection with coronavirus. | Usefulness of vitamin D on morbidity and mortality of SARS-COV-2 virus infection (Covid-19) at the Central University Hospital of Asturias - Vitamin D and COVID-19 | | Fundación para la Investigación y la Innovación Biosanitaria del Principado de Asturias (FINBA) | 21/05/2020 | 20200521 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002274-28 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 19/05/2020 | 60 | Interventional clinical trial of medicinal product | Controlled: no
Randomised: yes
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Spain | Managing director | | Avenida Hospital Universitario s/n | enrique.caso@gmail.com | 3498510 99 05 | Fundación para la Investigación y la Innovación Biosanitaria del Principado de Asturias (FINBA) | Inclusion criteria: <br>• Patients treated in the ER or admitted to the HUCA Hospitalization unit.<br>• Diagnosis of COVID19 demonstrated by positive PCR for SARS COV2 prior to randomization.<br>• Age> = 18 years.<br>• That they have accepted to participate in the study through informed consent.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 30<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 30<br> | Exclusion criteria: <br>• When discharge or a fatal outcome is expected within the next 48 hours.<br>• Obvious cognitive impairment (inability to communicate).<br>• PCR for SARS-COV 2 negative despite radiological, analytical and clinical findings compatible with this type of infection.<br>• Allergy to vitamin D.<br>• Patients who are receiving, or have received in the past 3 months, any form of vitamin D<br>• Pregnant women<br> | SARS-COV-2 infection <br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Videsil 100.000 UI<br>Pharmaceutical Form: Oral solution in sachet<br>INN or Proposed INN: COLECALCIFEROL<br>CAS Number: 67-97-0<br>Other descriptive name: VITAMIN D3<br>Concentration unit: IU international unit(s)<br>Concentration type: up to<br>Concentration number: 100.000-<br><br> | Main Objective: The objective of the study is to analyze if the administration of a single dose of native vitamin D (100,000 IU of Colecalciferol) (1 ampoule of 100,000) has an influence on the evolution of clinical and biochemical parameters of the disease.;Timepoint(s) of evaluation of this end point: 14 and 21 days or until a negative SARS-CoV-2 test every 7 days.;Primary end point(s): • Percentage and time of patients who have a negative SARS-CoV-2 viral load<br>• Clinical symptoms and time during hospitalization<br>• Improvement of biochemical and molecular parameters of inflammation<br>• Overall mean hospital stay<br>• Percentage of patients requiring transfer to the ICU<br>• Average stay in ICU<br>• Mortality during follow-up;Secondary Objective: Not applicable | | | | No | False | | |
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| IRCT20200506047323N6 | 30 November 2020 | Effect of Ivermectin in treatment of COVID-19 | The efficacy and safety of Ivermectin in patients with COVID-19: a randomized clinical trial | | Bandare-abbas University of Medical Sciences | 2020-11-17 | 20201117 | IRCT | http://en.irct.ir/trial/49501 | Recruiting | No | 20 years | no limit | Both | 2020-11-15 | 120 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients in both hospitalized (moderate) and outpatient (mild) groups will be randomized into the treatment and control groups based on the following method. Simple randomization method and table of random numbers will be used. If selected number is even, the patient is allocated to treatment group, and if it is odd, the patient is allocated to control group. | 3 | Iran (Islamic Republic of) | Mohammad Fathalipour | | Emam Hossein Blvd | m.fathalipour@hums.ac.ir | +98 76 3371 0406 | Bandare-abbas University of Medical Sciences | Inclusion criteria: Age =20 years old<br>Weight =35 kg<br>Positive polymerase chain reaction (PCR) test for COVID-19<br>Non-hospitalized mild as well as hospitalized moderate patients<br>Signed informed consent voluntarily and knowingly | Exclusion criteria: Underlying diseases (AIDS, asthma, severe liver and kidney disease)<br>History of Loiasis<br>History of drug allergy to Ivermectin<br>Use of anticoagulants (e.g. warfarin) and ACE inhibitors (e.g. captopril)<br>Pregnancy or breastfeeding | COVID-19 disease. <br>COVID-19, virus not identified;U07.2 | Intervention 1: Intervention group: will be mild patients receiving hydroxychloroquine sulfate (Amin Pharmaceutical company, Iran) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for six following days, along with oral Ivermectin (MSD company, France) at a single dose of 0.2 mg/kg. Intervention 2: Control group: will be mild patients receiving hydroxychloroquine sulfate (Amin Pharmaceutical company, Iran) at a dose of 400 mg twice a day for the first day and 200 mg twice a day for six following days. Intervention 3: Intervention group: will be moderate patients receive 200/50 mg Lopinavir/Ritonavir (Heterd company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day, plus oral Ivermectin (MSD company, France) at a single dose of 0.2 mg/kg. Intervention 4: Control group: will be moderate patients receive 200/50 mg Lopinavir/Ritonavir (Heterd company, India) twice a day for the seven days, plus five doses of 44 mcg Interferon beta-1a (CinnaGen, Iran) every other day. | Length of hospital stay. Timepoint: Until discharge date. Method of measurement: Questionnaire.;Need for ICU. Timepoint: Until discharge date. Method of measurement: Questionnaire.;Need for mechanical ventilation. Timepoint: Until discharge date. Method of measurement: Questionnaire. | | | | No | False | | |
| → | IRCT20160131026298N6 | 30 November 2020 | Evaluation of the effectiveness of Nigel-7 capsule and black seed mixture on corona | Evaluation of the effectiveness of Nigel-7 capsule and black seed mixture on COVID-19 | | Bagheiat-allah University of Medical Sciences | 2020-09-08 | 20200908 | IRCT | http://en.irct.ir/trial/50246 | Recruiting | No | 18 years | no limit | Both | 2020-11-05 | 80 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method will be blocked randomization (Blocks of size 4). Randomization units are individuals. Eighty outpatients referred to the hospital emergency department are randomly assigned to one of the two intervention and control groups according to form of random string produced by online random allocation . | 2-3 | Iran (Islamic Republic of) | Ahmad Reza Sharifi Olounabadi | | Vice-Chancellor for Research and Technology, Third Floor, Baqiyatallah University, Sheikh Bahaei St, Mulla Sadra St, Vanak Square | a-sharifi@bmsu.ac.ir | +98 21 8755 5250 | Bagheiat-allah University of Medical Sciences | Inclusion criteria: Male or female patients 18 years old and older with Coronavirus Disease 2019 (COVID-19)<br>Ground glass view at low-dose CT scan<br>Consciously completed consent form completed by the patient or the patient's supervisor | Exclusion criteria: History of pulmonary malignancy<br>History of asthma or COPD<br>History of Disabling disease or malignancy<br>Liver or kidney disorders | COVID-19. <br>U07.2 COVID-19, virus not identified, COVID-19;U07.2 | Intervention 1: Intervention group: Intervention groups will be two ones. Patients in the intervention group will receive the intervention drug (three capsules a day and ten grams of black seed mixture daily) that is made by Talaye sabze tooba company; in addition to the routine treatment (Azithromycin 250 mg daily for 10 days and Naproxen 250 mg twice a day for 10 days) . Intervention 2: Control group: The control group will receive the routine treatment (Azithromycin 250 mg daily for 10 days and Naproxen 250 mg twice a day for 10 days) . | Lung radiologic changes. Timepoint: At beginning and end of the study. Method of measurement: Chest CT scan.;Severity of shortness of breath. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Shortness Of Breath With Daily Activity (SOBDA) Questionnaire.;Measurement of cough severity. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Cough scoring form.→Measurement of cough severity. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Cough scoring form.;Severity of shortness of breath. Timepoint: Day 1 before and at the end of treatment. Method of measurement: Shortness Of Breath With Daily Activity (SOBDA) Questionnaire.;Lung radiologic changes. Timepoint: At beginning and end of the study. Method of measurement: Chest CT scan. | | | | Yes | False | | |
| IRCT20160919029870N3 | 30 November 2020 | The effect of selenium in patients with Covid-19 | Evaluation of the effectiveness of selenium added to intravenous nutrition therapy on mortality and duration of ICU hospitalization in patients with COVID-19 disease | | Ghoum University of Medical Sciences | 2020-11-24 | 20201124 | IRCT | http://en.irct.ir/trial/50425 | Not Recruiting | No | no limit | no limit | Both | 2020-03-20 | 80 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization is performed using block randomization with blocks of size 4. All four modes: AABB, ABAB, BBAA, BABA are written on four cards, and four patients are randomly allocated to groups, respectively. The ward's head takes the card out of the bag, and the patients are divided into groups by chance. For example, if the card is AABB, the first and second patients are in the first group, and the third and fourth patients are in the second group, and also for the next four patients, another card will be drawn, Blinding description: Since patients have no knowledge of the drug, they were blinded in this study. The researcher is unaware of the grouping of drugs, and after statistical analysis, it is determined that group A was the treatment group and group B was the control group. | 3 | Iran (Islamic Republic of) | Hamed Shafiee | | Clinical Research Unit; Nekouei hospital; Shahid Delazar street | rheidarifar@muq.ac.ir | +98 25 3133 1602 | Ghoum University of Medical Sciences | Inclusion criteria: Patients diagnosed with Covid-19 disease by infectious disease physician<br>Patients who are hospitalized in the special ward and three days have been passed since their hospitalization<br>Patients who are intubated and connected to a ventilator | Exclusion criteria: Patients with covid-19 who are not intubated. | COVID-19. <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: according to the protocol, in this group, one mg of selenium in the form of stat (initial dose and amount) and 500 micrograms of intravenous infusion for 15 minutes at 2 pm every day are administrated by an anesthesiologist for five days. Intervention 2: Control group: Routine procedures are performed on a patient with confirmed COVID-19. | Duration of hospitalization. Timepoint: The first day of patients' arrival and the day of discharge from the ICU or death of patients. Method of measurement: Number of days patients are admitted to the ICU. | | | | No | False | | |
| → | IRCT20200711048077N1 | 30 November 2020 | Evaluation of respiratory Tele-rehabilitation in patient with COVID-19 | The impact of respiratory Tele-rehabilitation on pulmonary function and quality of life in patient with COVID-19 | | Mashhad University of Medical Sciences | 2020-11-16 | 20201116 | IRCT | http://en.irct.ir/trial/50721 | Recruiting | No | 18 years | 80 years | Both | 2020-11-21 | 60 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Randomization of study will done by generating a random sequence with randomization.com for each research unit in two groups alternatively. The envelope method in the package is used to hide the random sequence. In this way, a random sequence is written on small cards as code A or B and is kept in a closed envelope. Whenever a research unit is found to meet the inclusion criteria, it is opened in an envelope and entered the group based on the first card. Becomes relevant. This will continue until the required number of research units are assigned to both groups, Blinding description: Participants will be informed that generally there will be two different groups in the study, in one different pulmonary rehabilitation exercises will be performed online and in the other one pulmonary rehabilitation training will be given via pamphlet. | N/A | Iran (Islamic Republic of) | Fateme Rangani | | No 10, Haft-e-Tir 5, Hafte-e-Tir Blvd, Vakilabad Blvd | ranganif981@mums.ac.ir | +98 51 3864 6372 | Mashhad University of Medical Sciences | Inclusion criteria: Willingness to participate in the study<br>Acceptable visual, auditory and alertness to participate in study<br>Ability to understand and speak Persian<br>Having online communication facilities such as internet and one of the smart devices such as laptop, tablet or smartphone.<br>Ability to use online technology or caregiver to access it during quarantine.<br>Patients who have been diagnosed with covid 19 and have a lung lesion based on the results of a CXR or CT scan with the approval of an infectious disease specialist<br>Discharge after treatment<br>Observance of social isolation<br>Having a cardiac echo at the time of admission that indicates heart health | Exclusion criteria: Having deformity in the chest<br>mental disorder<br>Any severe illness that impairs the movement of patients such as severe heart disease, severe musculoskeletal pain, vascular aneurysms, severe neurological diseases<br>Pregnancy<br>vestibular disorders | Coronavirus 2019. <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: For four weeks, every day for 30 minutes once a day for two set with 10 minutes of rest and hydration. The program includes one-minute diaphragmatic breathing exercises, 5-minute incentive spirometry exercises, 30-second sit to stand squats, 30-second standing marching, 30-second seated arm reaches, 30-second standing heel raises, 30-second sidestepping, 30- second Wall pushups. Individuals practice in groups of five on the Skyroom platform. Every day after training, the amount of fatigue and dyspenea based on the BORG scale, the number of exercises performed and problems during training in a special checklist for each The person is registered. Intervention 2: The usual training is done during discharge. They are given a training pamphlet on encouraging respiratory rehabilitation and spirometry exercises. Their condition is monitored daily by telephone. They are asked to record fatigue and shortness of breath and the number of exercises in the checklist. | Pulmonary function. Timepoint: At the beginning of the study (before the intervention) and at the end of the second week and at the end of the fourth week after the intervention. Method of measurement: By examining the six-minute walk test and measuring the maximum inspiratory pressure (MIP) and the percentage of blood oxygen saturation (SPO2).;Quality of life score in SF-36 questionnaire. Timepoint: At the beginning of the study (before the intervention) and at the end of the second week and at the end of the fourth week after the intervention. Method of measurement: SF-36 questionnaire.→Quality of life score in SF-36 questionnaire. Timepoint: At the beginning of the study (before the intervention) and at the end of the second week and at the end of the fourth week after the intervention. Method of measurement: SF-36 questionnaire.;Pulmonary function. Timepoint: At the beginning of the study (before the intervention) and at the end of the second week and at the end of the fourth week after the intervention. Method of measurement: By examining the six-minute walk test and measuring the maximum inspiratory pressure (MIP) and the percentage of blood oxygen saturation (SPO2). | | | | Yes | False | | |
| IRCT20200408046987N2 | 30 November 2020 | Determination the therapeutic effect of Ivermectin and Sovodak on patients infected with COVID-19 | Determination the therapeutic effect of Ivermectin and Sovodak on patients infected with COVID-19: A clinical trial. | | Akam Tejarat Fartak Farasoo | 2020-11-07 | 20201107 | IRCT | http://en.irct.ir/trial/51007 | Recruiting | No | 20 years | 80 years | Both | 2020-10-16 | 150 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, simple randomization method will be used. A randomized list will be generated by Randomizer randomization software. Patients will be allocated to case or control group according to the generated list, Blinding description: Participants will receive drug or placebo after signing the consort letter. Practitioner and consequence analyzer will not know about the treatment. Data analyzer will know the groups number only. | 2-3 | Iran (Islamic Republic of) | Nematollah Gheibi | | Bahonar Boulevard | ngheibi@qums.ac.ir | +98 28 3332 8212 | Qazvin University of Medical Sciences | Inclusion criteria: Patients who test positive for COVID-19 by a commercially available Test<br>Patients = 20 but < 65 years of age with a temperature (oral) of 38°C and patients 65 - 80 years of age with a temperature (oral) of 37.8°C<br>Patients with 2 or more of the following symptoms (moderate to severe in intensity) at the time of enrollment: Cough Sore throat Headache Nasal congestion Feeling feverisho Body aches and pains Fatigue (tiredness) | Exclusion criteria: patients with Immuno deficiency<br>patients under any other antiviral therapy | COVID-19. <br>COVID-19, virus identified;U07.1 | Intervention 1: Control group: Standard regimen based on Iran health ministry. Intervention 2: Control group: Standard regimen based on Iran health ministry plus Placebo,Once in first day. placebo is a simple tablet containing only fillers without any active ingredient and is made by Alborz Darou company. Intervention 3: Intervention group: Standard regimen based on Iran health ministry plus Ivermectin (400 mcg/kg , PO, Once) and Sovodak(400/60, PO, Once). Intervention 4: Intervention group: Standard regimen based on Iran health ministry plus high dose Ivermectin(400 mcg/kg in day1 followed by 200 mcg/kg in day 3 and day 5) and Sovodak(400/60, PO, Once). Intervention 5: Intervention group: High dose Ivermectin (400 mcg/kg in day1 followed by 200 mcg/kg in day 3 and day 5) and Sovodak(400/60, PO, Once). | Chest image(CT scan). Timepoint: at hospital clearance. Method of measurement: Patient's profile(CT scan image).;Hospitalization time. Timepoint: end of intervention. Method of measurement: Hospitalization time.;CBC. Timepoint: Before intervention, 7 days after intervention. Method of measurement: Sampling and lab test.;CRP. Timepoint: Before intervention, 7 days after intervention. Method of measurement: Sampling and lab test. | | | | No | False | | |
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| EUCTR2020-001472-14-IT | 7 December 2020 | Efficacy of pamrevlumab, a connective tissue growth factor monoclonal antibody, in patients with SARS-COV-2 infection. | AN OPEN-LABEL, RANDOMIZED, PARALLEL-ARM STUDY INVESTIGATING THE EFFICACY
AND SAFETY OF INTRAVENOUS ADMINISTRATION OF PAMREVLUMAB VERSUS STANDARD
OF CARE IN PATIENTS WITH SARS-COV-2 INFECTION - FibroCov | | Istituto Nazionale per le Malattie Infettive “Lazzaro Spallanzani” | 03/04/2020 | 20200403 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001472-14 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 06/05/2020 | 68 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Standard of care<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Italy | Mal. Infettive App. Respiratorio | | Via Portuense 292 | fabrizio.palmieri@inmi.it | 00390655170401 | Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani | Inclusion criteria: <br>-Patients with documented SARS-CoV-2 infection,<br>-Age >=20 to <=85 years with<br>-Interstitial pneumonia (as assessed by chest X-ray or HRCT) <br>-Patients requiring hospitalization. <br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 48<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 20<br> | Exclusion criteria: <br>Patients on invasive mechanical ventilator for more than 2 days.<br> | Patients with documented SARS-CoV-2 infection;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Pamrevlumab<br>Product Code: FG-3019<br>Pharmaceutical Form: Infusion<br><br> | Timepoint(s) of evaluation of this end point: at day 5. (Day 1 is defined as the day of randomization which must also include administration of the first dose of pamrevlumab);Primary end point(s): Change from baseline in PaO2/FiO2 ratio ;Secondary Objective: The secondary objective of this study is to evaluate the safety and tolerability profile of pamrevlumab in patients with SARS-CoV-2 infection requiring hospitalization.;Main Objective: The primary objective of this study is to assess the effect of pamrevlumab on the efficiency of blood oxygenation in patients with SARS-CoV-2 infection requiring hospitalization | | | | Yes | False | | |
| → | EUCTR2020-001654-21-DE | 7 December 2020 | Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to prevent ARDS in COVID-19 pneumonia
| Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) Inhalation to prevent ARDS in COVID-19 pneumonia
- GI-COVID | | Justus-Liebig-University Gießen | 05/05/2020 | 20200505 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001654-21 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 16/09/2020 | 238 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany | Project manager | | Karl-von-Frisch Str. 4 | nelli.ens@kks.uni-marburg.de | +4964212826598 | Koordinierungszentrum für Klinische Studien der Philipps-Universität Marburg (KKS Marburg) | Inclusion criteria: <br>1. Signed informed consent form by the patient according to local regulations<br>2. Man or non-pregnant woman <br>3. Age =18 years <br>4. Willingness of patients with reproductive potential to use highly effective contraceptive methods by practicing abstinence or by using at least two methods of birth control from the date of consent to the end of the study. If abstinence could not be practiced, a combination of hormonal contraceptive (oral, injectable, or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used *. <br>5. Lab-confirmed COVID-19 pneumonia where pneumonia is diagnosed by radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR clinical assessment (evidence of rales/crackles on exam) AND SpO2 = 94% >= 94% at room air in patients that do not have chronic hypoxia; or less than their baseline oxygenation in patients that suffer from chronic hypoxia<br>6. Negative serum pregnancy test in women of childbearing potential<br><br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 119<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 119<br> | Exclusion criteria: <br>1. Pregnancy or breast feeding <br>2. Autoimmune thrombocytopenia, myelodysplastic syndromes with > 20% marrow blast cells<br>3. History or presence of hypersensitivity or idiosyncratic reaction to molgramostim (e.g. Leucomax®) or to related compounds (e.g. Leukine®)<br>4. Patient not able to use nebulizer device as well as immediately foreseeable mechanical ventilation of the patient<br>5. Simultaneous participation in another clinical trial with an experimental treatment<br><br><br><br><br> | COVID-19 pneumonia <br>MedDRA version: 23.1
Level: PT
Classification code 10084380
Term: COVID-19 pneumonia
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Molgradex 300 mcg nebuliser solution<br>Pharmaceutical Form: Nebuliser solution<br>INN or Proposed INN: Molgramostim<br>CAS Number: 99283-10-0<br>Concentration unit: µg/ml microgram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 250-<br>Pharmaceutical form of the placebo: Nebuliser solution<br>Route of administration of the placebo: Inhalation use<br><br> | Main Objective: • To assess the efficacy of inhaled molgramostim (300µg) compared to placebo when administered to patients with COVID-19 pneumonia in preventing progression to ARDS (= non-invasive or invasive ventilation) measured as the cumulative proportion of patients who required mechanical ventilation during a 15 days period following randomization. ;Timepoint(s) of evaluation of this end point: Day 15;Primary end point(s): • Need for mechanical ventilation within 15 days after randomization;Secondary Objective: • To assess the efficacy of inhaled molgramostin to reduce the need for oxygen supply in patients with COVID-19 pneumonia measured as the cumulative proportion of patients who required oxygen supply during a 15 days period following randomization<br>• To assess clinical morbidity in patients with COVID-19 pneumonia treated with inhaled molgramostim comparing the change in clinical status of subject on the 7-point ordinal scale (see secondary endpoints given below) from baseline to day 15 <br>• Mortality rate at day 15 and day 29<br>• To assess levels of GM-CSF in serum after 300µg of inhaled molgramostim compared to placebo when administered to patients with COVID-19 pneumonia<br>• To assess viral loads in swabs or tracheal aspirates in patients with COVID-19 pneumonia treated with inhaled molgramostim compared to placebo<br>• To assess safety and tolerability of inhaled molgramostim (300µg) when administered to patients with COVID-19 pneumonia<br><br><br>→Timepoint(s) of evaluation of this end point: Day 15;Primary end point(s): • Need for mechanical ventilation within 15 days after randomization;Secondary Objective: • To assess the efficacy of inhaled molgramostin to reduce the need for oxygen supply in patients with COVID-19 pneumonia measured as the cumulative proportion of patients who required oxygen supply during a 15 days period following randomization<br>• To assess clinical morbidity in patients with COVID-19 pneumonia treated with inhaled molgramostim comparing the change in clinical status of subject on the 7-point ordinal scale (see secondary endpoints given below) from baseline to day 15 <br>• Mortality rate at day 15 and day 29<br>• To assess levels of GM-CSF in serum after 300µg of inhaled molgramostim compared to placebo when administered to patients with COVID-19 pneumonia<br>• To assess viral loads in swabs or tracheal aspirates in patients with COVID-19 pneumonia treated with inhaled molgramostim compared to placebo<br>• To assess safety and tolerability of inhaled molgramostim (300µg) when administered to patients with COVID-19 pneumonia<br><br><br>;Main Objective: • To assess the efficacy of inhaled molgramostim (300µg) compared to placebo when administered to patients with COVID-19 pneumonia in preventing progression to ARDS (= non-invasive or invasive ventilation) measured as the cumulative proportion of patients who required mechanical ventilation during a 15 days period following randomization. | | | | Yes | True | parent | |
| EUCTR2020-001228-32-GB | 7 December 2020 | Investigating a Vaccine Against COVID-19 | A phase 2/3 study to determine the efficacy, safety and immunogenicity of the candidate Coronavirus Disease (COVID-19) vaccine ChAdOx1 nCoV-19 - Investigating a Vaccine Against COVID-19 (COV002) | | CTRG | 21/04/2020 | 20200421 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001228-32 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 04/05/2020 | 12390 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: yes<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 5<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| United Kingdom | Andrew Pollard | | CCVTM, Churchill Hospital | Andrew.pollard@paediatrics.ox.ac.uk | +4418655611400 | University of Oxford | Inclusion criteria: <br> Adults aged 18 years or older (groups 4 and 6); aged 18-55 years (group 5 and 11) <br> Adults aged 56-69 years (groups 1,7 and 9)<br> Adults aged 70 years and older (groups 2,8 and 10)<br> <br> Able and willing (in the Investigator’s opinion) to comply with all study requirements.<br> Willing to allow the investigators to discuss the volunteer’s medical history with their General Practitioner and access all medical records when relevant to study procedures.<br> For females of childbearing potential only, willingness to practice continuous effective contraception (see below) during the study and a negative pregnancy test on the day(s) of screening and vaccination.<br> Agreement to refrain from blood donation during the course of the study.<br> Provide written informed consent.<br> Parent/Guardian provides informed consent<br><br>Additional Inclusion criteria to Group 12 (HIV sub-study): <br> HIV positive<br> Receiving antiretroviral therapy<br> Undetectable HIV viral load<br> CD4>350 cells/mL<br><br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: 0<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 11090<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 1240<br> | Exclusion criteria: <br> • Participation in COVID-19 prophylactic drug trials for the duration of the study. <br>Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalisation due to COVID-19. The COV002 study team should be informed as soon as possible. <br>• Participation in SARS-CoV-2 serological surveys where participants are informed of their serostatus for the duration of the study. <br>Note: Disclosure of serostatus post enrolment may accidently unblind participants to group allocation. Participation in COV002 can only be allowed if volunteers are kept blinded to their serology results from local/national serological surveys <br>• Receipt of any vaccine (licensed or investigational) other than the study intervention within 30 days before and after each study vaccination, with the .exception of the licensed seasonal influenza vaccination and the licenced pneumococcal vaccination. Participants will be encouraged to receive these vaccination at least 7 days before or after their study vaccine.<br>• Prior or planned receipt of an investigational or licensed vaccine or product likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). ). This exclusion criteria will not apply to group 11, as recruitment will be targeted at those volunteers who previously received a ChAdOx1 vectored vaccine. <br>• Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate.<br>• Any confirmed or suspected immunosuppressive or immunodeficient state (except group 12, where HIV infected participants are allowed); asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting =14 days)<br>• History of allergic disease or reactions likely to be exacerbated by any component of ChAdOx1 nCoV-19 or MenACWY<br>• Any history of angioedema.<br>• Any history of anaphylaxis.<br>• Pregnancy, lactation or willingness/intention to become pregnant during the study.<br>• Current diagnosis of or treatment for cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ).<br>• History of serious psychiatric condition likely to affect participation in the study.<br>• Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture.<br>• Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)<br>• Suspected or known current alcohol or drug dependency.<br>• Any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data.<br>• Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed)<br>• History of laboratory confirmed COVID-19 (except groups 5d, 5e, 9, 10 and 11).<br> - Seropositivity to SARS-CoV-2 before enrolment (except groups 5d, 5e, 9, 10 and 11)<br> - NB: volunteers with previous PCR or other NAAT positive result are also allowed in groups 9, 10 and 11<br><br>Additional Exclusion | SARS-CoV-2 <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: ChAdOx1 nCoV-19<br>Pharmaceutical Form: Solution for injection<br><br>Trade Name: Nimenrix<br>Product Name: Nimenrix<br>Pharmaceutical Form: Powder and solvent for solution for injection<br><br>Trade Name: Menveo<br>Product Name: Menveo<br>Pharmaceutical Form: Powder and solvent for solution for injection<br><br> | Timepoint(s) of evaluation of this end point: As required;Primary end point(s): Virologically confirmed (PCR or other NAAT positive result) symptomatic COVID-19 infection;Secondary Objective: To assess the safety, tolerability and reactogenicity profile of the candidate vaccine ChAdOx1 nCoV-19<br>To assess efficacy of the candidate ChAdOx1 nCoV-19 against severe and non-severe COVID-19<br>To assess humoral immunogenicity of ChAdOx1 nCoV-19<br>To assess cellular immunity of ChAdOx1 nCoV-19 in older adults (groups 1, 2, 7 and 8 only)<br>To assess the safety and immunogenicity of a booster dose of ChAdOx1 nCoV-19 in older adults aged 56 years or older (two-dose schedules for groups 1, 2, 7 and 8 only)<br>Exploratory Immunology <br>Measure exposure to COVID-19 <br>To assess efficacy of the candidate ChAdOx1 nCoV-19 against SARS-CoV-2 infection <br>Compare safety, reactogenicity and immunogenicity between different manufacturing batches of ChAdOx1 nCoV-19 used in COV001 and COV002<br>Compare safety, reactogenicity and immunogenicity between different dosing methods (Abs260, Abs260 corrected for PS80 and qPCR) of ChAdOx1 nCoV-19 <br>To assess vaccine induced mucosal immunity <br>To compare viral shedding on sto;Main Objective: To assess efficacy of the candidate ChAdOx1 nCoV-19 against COVID-19 in adults aged 18 years and older.<br>To assess the safety of the candidate vaccine ChAdOx1 nCoV-19 in adults.<br> | | | | Yes | True | parent | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04252885 | 12 December 2020 | The Efficacy of Lopinavir Plus Ritonavir and Arbidol Against Novel Coronavirus Infection | A Randomized, Open-label, Controlled Study of the Efficacy of Lopinavir Plus Ritonavir and Arbidol for Treating With Patients With Novel Coronavirus Infection | ELACOI | Guangzhou 8th People's Hospital | 30/01/2020 | 20200130 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04252885 | Not recruiting | No | 18 Years | 80 Years | All | January 28, 2020 | 86 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 4 | China | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - In sputum, throat swab, lower respiratory tract secretion, blood and other samples,
<br> the nucleic acid of the novel coronavirus was positive, or the sequencing of the virus
<br> gene was highly homologous with the known novel coronavirus
<br>
<br> - Age is between 18-80 years old, the weight is more than 30kg, and there is no limit
<br> for men and women
<br>
<br> - The following conditions were met: creatinine = 110 umol / L, creatinine clearance
<br> rate (EGFR) = 60 ml / min / 1.73m2, AST and ALT = 5 × ULN, TBIL = 2 × ULN;
<br>
<br> - The subjects should fully understand the purpose, nature, method and possible reaction
<br> of the study, voluntarily participate in the study and sign the informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Have a clear history of lopinavir or ritonavir or arbidol allergy
<br>
<br> - Severe nausea, vomiting, diarrhea and other clinical manifestations affect the oral or
<br> absorption of the drugs
<br>
<br> - At the same time, take drugs that may interact with lopinavir or ritonavir or arbidol
<br>
<br> - Patients with serious underlying diseases, including but not limited to heart disease
<br> (including history of angina pectoris or coronary heart disease or myocardial
<br> infarction, atrioventricular block), lung, kidney, liver malfunction and mental
<br> diseases that cannot be treated together
<br>
<br> - ancreatitis or hemophilia
<br>
<br> - Pregnant and lactating women
<br>
<br> - Suspected or confirmed history of alcohol and drug abuse
<br>
<br> - Participated in other drug trials in the past month
<br>
<br> - The researchers judged that patients were not suitable for the study
<br> | | Coronavirus Infections | Drug: Lopinavir and Ritonavir Tablets;Drug: Arbidol | The rate of virus inhibition | | | | Yes | False | | |
| → | NCT04254874 | 12 December 2020 | A Prospective/Retrospective,Randomized Controlled Clinical Study of Interferon Atomization in the 2019-nCoV Pneumonia | An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Two Therapeutic Schemes(Abidol Hydrochloride,Abidol Hydrochloride Combined With Interferon Atomization)in the Treatment of 2019-nCoV Pneumonia. | | Tongji Hospital | 02/02/2020 | 20200202 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04254874 | Recruiting | No | 18 Years | N/A | All | February 1, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). | Phase 4 | China | ; | Qing Ning, Professor;Qin Ning, professor | | qning@vip.sina.com;qning@vip.sina.com | +8613971521450; | |
<br> Inclusion Criteria:
<br>
<br> 1)2019-nCoV nucleic acid test was positive. 2)CT of the lung conformed to the manifestation
<br> of viral pneumonia.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients who meet any of the contraindications in the experimental drug labeling
<br>
<br> 2. Patients who do not want to participate in this clinical study
<br> | | 2019-nCoV | Drug: Abidol hydrochloride;Drug: Abidol Hydrochloride combined with Interferon atomization | Rate of disease remission;Time for lung recovery→Time for lung recovery;Rate of disease remission | | | | Yes | False | | |
| NCT04255017 | 12 December 2020 | A Prospective/Retrospective,Randomized Controlled Clinical Study of Antiviral Therapy in the 2019-nCoV Pneumonia | An Open, Prospective/Retrospective, Randomized Controlled Cohort Study to Compare the Efficacy of Three Antiviral Drugs(Abidol Hydrochloride, Oseltamivir and Lopinavir/Ritonavir) in the Treatment of 2019-nCoV Pneumonia. | | Tongji Hospital | 02/02/2020 | 20200202 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04255017 | Recruiting | No | 18 Years | N/A | All | February 1, 2020 | 400 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). | Phase 4 | China | ; | Qing Ning, Professor;Qin Ning, professor | | qning@vip.sina.com;qning@vip.sina.com | +8613971521450; | |
<br> Inclusion Criteria:
<br>
<br> 1. 2019-nCoV nucleic acid test was positive.
<br>
<br> 2. CT of the lung conformed to the manifestation of viral pneumonia.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients who meet any of the contraindications in the experimental drug labeling
<br>
<br> 2. Patients who do not want to participate in this clinical study
<br> | | 2019-nCoV | Drug: Abidol hydrochloride;Drug: Oseltamivir;Drug: Lopinavir/ritonavir | Time for lung recovery;Rate of disease remission | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04327674 | 12 December 2020 | The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19 | The Use of Focused Lung Ultrasound in Patients Suspected of COVID-19 | | University of Aarhus | 27/03/2020 | 20200327 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04327674 | Recruiting | No | 18 Years | N/A | All | March 14, 2020 | 375 | Observational [Patient Registry] | | | Denmark | ; | Søren H Skaarup;Søren H Skaarup | | ;soeska@rm.dk | ;28911869 | Aarhus Universitets Hospital; |
<br> Inclusion Criteria:
<br>
<br> - Clinical suspicion of COVID-19 requiring contact to a hospital.
<br>
<br> Exclusion Criteria:
<br>
<br> - Age less than 18 years
<br>
<br> - Previous enrollment in this study.
<br> | | COVID-19 | | FLUS findings and respiratory failure | | | | Yes | False | | |
| → | NCT04328129 | 12 December 2020 | Household Transmission Investigation Study for COVID-19 in Tropical Regions | Household Transmission Investigation Study for Coronavirus Disease 2019 (COVID-19) in Tropical Regions | EPI-COVID-19 | Institut Pasteur | 23/03/2020 | 20200323 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04328129 | Recruiting | No | N/A | N/A | All | March 23, 2020 | 1300 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label). | N/A | French Guiana;Guadeloupe;New Caledonia;French Guiana;Guadeloupe;New Caledonia→New Caledonia;Guadeloupe;French Guiana;New Caledonia;Guadeloupe;French Guiana | ; | Claude Flamand, PhD;Claude Flamand, Phd | | ;cflamand@pasteur-cayenne.fr | ;+33 5 94 29 26 15 | Institut Pasteur de la Guyane, Head of Epidemiology Unit; |
<br> Inclusion Criteria:
<br>
<br> - Primary case: laboratory-confirmed coronavirus SARS-CoV-2 infection by polymerase
<br> chain reaction (PCR),
<br>
<br> or Family contact in French Guiana and Guadeloupe: person who lived in the same household
<br> as the primary case of COVID-19 when the primary case was symptomatic. A household is
<br> defined as a group of people (2 or more) living in the same accommodation (excluding
<br> residential institutions such as boarding schools, dormitories, hostels, prisons, other
<br> communities hosting grouped people),
<br>
<br> or Close contact in New-Caledonia: any individual who was in contact with a primary case,
<br> in his/her family/living environment, work/school, friends/leisure or means of transport,
<br> when the primary case was symptomatic or presymptomatic,
<br>
<br> - Affiliated or beneficiary of a social security system
<br>
<br> - Informed consent prior to initiation of any study procedures from subject (or legally
<br> authorized representative)
<br>
<br> - State of health compatible with a blood sample as defined in the protocol.
<br>
<br> Exclusion Criteria:
<br>
<br> - Inability to consent
<br>
<br> - Person under guardianship or curatorship
<br>
<br> - Known pathology or a health problem contraindicated with the collect of blood sample.
<br> | | Coronavirus Infections;Severe Acute Respiratory Syndrome;SARS-CoV Infection | Procedure: Human biological samples | Evaluation of the extent of the virus transmission within households | | | | Yes | False | | |
| NCT04328272 | 12 December 2020 | Effectiveness of Hydroxychloroquine in Covid-19 Patients | Effectiveness of Hydroxychloroquine in Covid-19 Patients: A Single Centred Single-blind RCT Study | Covid | Prof. Dr. Umar Farooq | 25/03/2020 | 20200325 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04328272 | Not recruiting | No | 18 Years | 50 Years | All | March 28, 2020 | 75 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). | Phase 3 | Pakistan | ; ; | Umar Farooq, PhD;Umar Farooq, PhD;Umer Farooq, PhD | | ;dean@ayubmed.edu.pk;dean@ayubmed.edu.pk | ;00923219111681;00929929311100 | Khyber Medical University Peshawer; |
<br> Inclusion Criteria:
<br>
<br> - Confirmed cases of Covid-19 (all by RT-PCR from same laboratory)
<br>
<br> - Mild to severe clinical presentation (identified at the time of admission to ward by
<br> National Early Warning Score NEWS-2; mild 0-4; severe 5-6)
<br>
<br> Exclusion Criteria:
<br>
<br> - Covid-19 critically ill patients (NEWS-2 score <7),
<br>
<br> - Unable to take oral medication,
<br>
<br> - Immunocompromised,
<br>
<br> - Creatinine clearance (CCL) < 30 ml/min,
<br>
<br> - Aspartate transaminase (AST) or alanine transaminase (ALT) > 5 times Upper limit of
<br> normal (ULN),
<br>
<br> - d-dimer > 2microgram per liter, or
<br>
<br> - Known comorbid condition like hypertension, cardiovascular disease, diabetes mellites,
<br> asthma, COPD, cerebrovascular disorder, malignancy of any type, pregnancy,
<br>
<br> - BMI less than 18
<br>
<br> - Smoking history (one pack per day) for past six months
<br> | | COVID19 | Drug: Hydroxychloroquine 200 Mg Oral Tablet;Drug: Azithromycin 500Mg Oral Tablet;Dietary Supplement: Glucose tablets | National Early Warning Score equal to zero | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04352764 | 12 December 2020 | ANTIBODY BASED TESTS FOR SARSCoV-2 COVID-19) - Evaluation of Patients and Healthcare Providers in the Confines of Healthcare Settings | Use of the ANTIBODY BASED LATERAL FLOW IMMUNOASSAY TESTS FOR SARSCoV-2 THAT CAUSES CORONAVIRUS DISEASE 2019 (COVID-19) - Evaluation of Patients and Healthcare Providers in the Confines of Healthcare Settings | | Texas Cardiac Arrhythmia Research Foundation | 16/04/2020 | 20200416 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04352764 | Recruiting | No | N/A | N/A | All | March 27, 2020 | 5000 | Observational [Patient Registry] | | | United States | ; | Andrea Natale, MD;Andrea Natale, MD FACC FHRS | | dr.natale@gmail.com;dr.natale@gmail.com | 512-544-8186; | |
<br> Inclusion Criteria:
<br>
<br> - Patient is Under the care of Texas Cardiac Arrhythmia, and Presenting to the hospital
<br> OR Presenting to a clinic conducted by Texas Cardiac Arrhythmia Or
<br>
<br> - An employee of Texas Cardiac Arrhythmia Or
<br>
<br> - An employee or healthcare professional working with patients receiving cardiac
<br> electrophysiology care at a hospital. Or A professional first responder to
<br> include Emergency Medical Services (EMS), Police or Fire departments.
<br>
<br> Exclusion Criteria:
<br>
<br> - Any person who refuses to undergo study procedures
<br> | | Covid19 | Diagnostic Test: CoronaCideTM COVID-19 IgM/IgG Rapid Test and Premier Biotech COVID-19 IgM/IgG Rapid Test | prevalence of COVID-19 exposure | | | | Yes | False | | |
| → | NCT04352803 | 12 December 2020 | Adipose Mesenchymal Cells for Abatement of SARS-CoV-2 Respiratory Compromise in COVID-19 Disease | IV Infusion of Autologous Adipose Derived Mesenchymal Cells for Abatement of Respiratory Compromise in SARS-CoV-2 Pandemic (COVID-19) | | Regeneris Medical | 16/04/2020 | 20200416 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04352803 | Not recruiting | No | 18 Years | 90 Years | All | April 2020 | 20 | Interventional | Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | | | Ryan Welter, MD PhD | | r.welter@regenerismedical.com | (508) 576-8325 | |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female patients = 18 years of and less than 90
<br>
<br> 2. COVID 19 diagnosis confirmed
<br>
<br> 3. Ability to give informed consent
<br>
<br> 4. Hospitalized
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Mild Illness
<br>
<br> 1. Patients with uncomplicated upper respiratory tract viral infection, may have
<br> non-specific symptoms such as fever, fatigue, cough (with or without sputum
<br> production), anorexia, malaise, muscle pain, sore throat, dyspnea, nasal
<br> congestion, or headache. Rarely, patients may also present with diarrhea, nausea
<br> and vomiting.
<br>
<br> 2. The elderly and immunosuppressed candidates may present with atypical symptoms.
<br> Symptoms due to physiologic adaptations of pregnancy or adverse pregnancy events,
<br> such as e.g. dyspnea, fever, GI-symptoms or fatigue, may overlap with COVID-19
<br> symptoms. Still, they will be excluded, unless they progress to Inclusion
<br> Criteria within 72 hours from recruitment.
<br>
<br> 2. Pneumonia (uncomplicated):
<br>
<br> a. Adults with pneumonia but no signs of severe pneumonia AND NO need for supplemental
<br> oxygen
<br>
<br> 3. Reported pregnant or positive pregnancy test
<br>
<br> 4. Other chronic respiratory disorders such as COPD, emphysema, lung cancer, or cystic
<br> fibrosis
<br>
<br> 5. BMI lower than 21
<br>
<br> 6. Skinfold test < 3 cm at harvest area
<br>
<br> 7. Patients with Do-Not-Resuscitate orders that limit mechanical ventilation assistance
<br> in place at hospital admission
<br>
<br> 8. Males and females < 18 years of age
<br>
<br> 9. Patients who are currently breastfeeding
<br>
<br> 10. Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory
<br> infection viruses.
<br>
<br> 11. History of systemic malignant neoplasms within the last 5 years.
<br>
<br> 12. Subject is in the opinion of the Investigator or designee, unable to comply with the
<br> requirements of the study protocol or is unsuitable for the study for any reason
<br>
<br> 13. Participating in another clinical research study
<br>
<br> 14. History of Bleeding disorder which in PI's opinion would render the patient unsuitable
<br> for the study
<br>
<br> 15. PT (plasma) < 9 or >11.6 seconds and in the opinion of the PI and attending physician
<br> that lipoaspiration would be contraindicated. May be eligible for re-screening if
<br> coagulopathy improves within 72 hours of consent
<br>
<br> 16. PTT < 23 or >32 seconds and in the opinion of the PI and attending physician that
<br> lipoaspiration would be contraindicated. May be eligible for re-screening if
<br> coagulopathy improves within 72 hours of consent
<br>
<br> 17. Platelets count less than 70,0000
<br>
<br> 18. History of DVT
<br> | | Covid-19 Pneumonia;Cyotokine Storm | Biological: Autologous Adipose MSC's | Efficacy - Changes in mortality rate;Efficacy - Changes in length of hospital stay;Efficacy - Changes in length of weaning of mechanical ventilation;Efficacy - Changes in length of mechanical ventilation;Efficacy - Frequency of progression to mechanical ventilation;Safety - Incidence of unexpected adverse events→Safety - Incidence of unexpected adverse events;Efficacy - Frequency of progression to mechanical ventilation;Efficacy - Changes in length of mechanical ventilation;Efficacy - Changes in length of weaning of mechanical ventilation;Efficacy - Changes in length of hospital stay;Efficacy - Changes in mortality rate | | | | Yes | False | | |
| NCT04352842 | 12 December 2020 | Echocardiographic Manifestation in Patient With COVID-19 (EARLY-MYO COVID-19) | Cardiac Structural and Functional Characteristics in COVID-19: A Dynamic Echocardiographic Study | | RenJi Hospital | 16/04/2020 | 20200416 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04352842 | Not recruiting | No | 18 Years | N/A | All | January 21, 2020 | 51 | Observational | | | China | | Jun Pu, M.D | | | | Renji Hospital, School of Medicine, Shanghai Jiaotong University |
<br> Inclusion Criteria:
<br>
<br> Patients had been diagnosed of COVID-19 according to the criteria established by the WHO
<br> interim guidance and admitted to ICU because of severe or critical condition
<br>
<br> Exclusion Criteria:
<br>
<br> Patients who were < 18 years and whose entire stay in hospital lasted for < 48 hours.
<br> | | Covid19;Echocardiography | Other: Echocardiography | Death | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04358380 | 12 December 2020 | Liver Injury in Patients With COVID-19 | Liver Injury in Hospitalized Patients With COVID-19 in Latin America: Clinical Characteristics and Prognostic Factors | | Austral University, Argentina | 18/04/2020 | 20200418 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04358380 | Recruiting | No | 17 Years | N/A | All | April 15, 2020 | 320 | Observational | | | Argentina | | Marcelo O Silva, MD | | | | Austral University |
<br> Inclusion Criteria:
<br>
<br> - Patients older than 17 years
<br>
<br> - Patients with diagnosis of SARS-CoV-2 infection
<br>
<br> - Hospitalized patients
<br>
<br> Exclusion Criteria:
<br>
<br> -
<br> | | Liver Injury | Other: Liver injury | Liver injury in patients with COVID-19 | | | | Yes | False | | |
| → | NCT04358510 | 12 December 2020 | COVID-19 Mortality Prediction Model | Mortality Prediction Model for the Triage of COVID-19, Pneumonia and Mechanically Ventilated ICU Patients | | Dascena | 20/04/2020 | 20200420 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04358510 | Not recruiting | No | 18 Years | N/A | All | April 1, 2020 | 114 | Observational | | | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Patients aged 18 years or older
<br>
<br> - Record of ICU stay
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients aged less than 18 years
<br>
<br> - Patients for which there were no records of raw data or no discharge or death dates.
<br> | | COVID-19;Pneumonia;Mechanical Ventilation | Device: COViage | Mortality outcome in COVID-19 ICU patients;Mortality outcome in mechanically ventilated ICU patients;Mortality outcome in pneumonia ICU patients→Mortality outcome in pneumonia ICU patients;Mortality outcome in mechanically ventilated ICU patients;Mortality outcome in COVID-19 ICU patients | | | | Yes | False | | |
| NCT04358536 | 12 December 2020 | Classification of COVID-19 Infection in Posteroanterior Chest X-rays | Classification of COVID-19 Infection in Posteroanterior Chest X-rays With Common Deep Learning Architectures | | Dascena | 20/04/2020 | 20200420 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04358536 | Not recruiting | No | 18 Years | N/A | All | April 1, 2020 | 230 | Observational | | | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Single PCX images collected from patients over 18 years of age
<br>
<br> Exclusion Criteria:
<br>
<br> - CT scans composed of multiple concerted X-rays
<br>
<br> - Single PCX images collected from patients under 18 years of age
<br> | | COVID-19 | Device: CovX | Identification of COVID-19 | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04377308 | 12 December 2020 | Fluoxetine to Reduce Intubation and Death After COVID19 Infection | Fluoxetine to Reduce Intubation and Death After COVID19 Infection | | University of Toledo Health Science Campus | 18/04/2020 | 20200418 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04377308 | Recruiting | No | 18 Years | N/A | All | May 1, 2020 | 2000 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 4 | United States | ; | Cheryl McCullumsmith, MD PhD;Cheryl McCullumsmith, MD PhD | | cheryl.mccullumsmith@utoledo.edu;cheryl.mccullumsmith@utoledo.edu | 419.383.5651;419-383-5651 | |
<br> Inclusion Criteria:
<br>
<br> - Patients aged 18 and above, able to give informed consent or with legally authorized
<br> representative
<br>
<br> - COVID-19 test positive or presumptive positive awaiting COVID testing or results by
<br> following criteria: fever, cough and shortness of breath or presumptive positive by
<br> one of these 3 criteria (fever, cough or shortness of breath) and known exposure to
<br> COVID-19 positive individual in past 2 weeks
<br>
<br> Overall Study Exclusion Criteria :
<br>
<br> - Unable to give informed consent and no legal representativ
<br>
<br> - Prisoner/ institutionalized patient
<br>
<br> - Under age 18
<br>
<br> Exclusion from Fluoxetine Arm:
<br>
<br> - Active bleeding requiring blood products
<br>
<br> - Bipolar disorder not on mood stabilizing medication*
<br>
<br> - Known allergy or hypersensitivity to fluoxetine
<br>
<br> - Currently taking the following medications : MAO I, pimozide, thioridine
<br>
<br> - Currently taking hydroxychloroquine
<br>
<br> - Pregnant or breastfeeding
<br>
<br> - For hospitalized patients : QTc greater than 500 ms
<br>
<br> - *Hospitalized patient may be on hydroxychloroquine if QTc<500 and the primary
<br> attending approves
<br>
<br> Exclusion from Blood Sample Provision:
<br>
<br> - Pregnant
<br>
<br> - Self-report of under 110 pounds
<br> | | COVID-19;Cytokine Storm | Drug: Fluoxetine | Death;Intubation;Hospitalizations | | | | Yes | False | | |
| → | NCT04377412 | 12 December 2020 | Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic | Risk Factors for Anxiety and Depression Among Pregnant Women During the COVID-19 Pandemic - a Web-based Cross-sectional Survey | MindCOVID | Zelazna Medical Centre, LLC | 02/05/2020 | 20200502 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04377412 | Recruiting | No | 18 Years | N/A | Female | May 1, 2020 | 8500 | Observational | | | United States;Albania;Australia;Czechia;France;Germany;Hong Kong;Israel;Italy;Lebanon;Norway;Poland;Spain;Sweden;Taiwan;Albania;Australia;Czechia;France;Germany;Hong Kong;Israel;Italy;Lebanon;Norway;Poland;Spain;Sweden;Taiwan;United States→United States;Albania;Australia;Czechia;Taiwan;United States;Sweden;Spain;Poland;Norway;Lebanon;Italy;Israel;Hong Kong;Germany;France;Czechia;Australia;Albania;Taiwan;Sweden;Spain;Poland;Norway;Lebanon;Italy;Israel;Hong Kong;Germany;France | ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; ; | Anna Kajdy, MD, PhD;Michal Rabijewski, MD, PhD, Professor;Dorota Sys, PhD;Jan Modzelewski, MD;Sebastian Kwiatkowski, MD, PhD;Roksana Lewandowska, MD;Dariusz Borowski, MD, PhD;Barbara Baranowska, PhD, RM;Artur Pokropek, PhD, Professor;Urszula Ajdacka, MD;Stepan Feduniw, MD;Maria del Mar Gil Mira, MD, PhD;Simone Schwank, PhD M.S. M.A. Msc. Clinical Ps;Ksenia Olisova, MD, MPH;Tung-Yao Chang, MD, M Med Sci;Steven Shaw;Sonia Hassan, MD;Jade Harris, MD;Orion Gliozheni, MD;Jon Hayett, Professor;Pavel Calda, MD, MSc, Professor;Laurent J Salomon, MD, PhD, Professor;Stefan Verlohren, MD, Professor;Liona C Poon, MBBS, MRCOG, Professor;Tal Biron-Shental, MD;Maya Ben-Zion, MD;Federico Prefumo, MD, PhD;Gihad Chalouhi, MD, PhD;Ganesh Acharya, MD, PhD, FRCOG, Professor;Heidi Tiller, MD, PhD;Karine Stiberg Birkelund;Solrun Rasmussen;Ewa Andersson, RNM, PhD;Anna Kajdy, MD, PhD | | ;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;akajdy@cmkp.edu.pl | ;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;;+48663769515 | Centre of Postgraduate Medical Education;Centre of Postgraduate Medical Education;Centre of Postgraduate Medical Education;Centre of Postgraduate Medical Education;Pomeranian Medical University Szczecin;Pomeranian Medical University Szczecin;Nicolaus Copernicus University in Torun, Collegium Medicum in Bydgoszcz;Centre of Postgraduate Medical Education;Institute of Philosophy and Sociology of the Polish Academy of Sciences;Central Clinical Hospital of Ministry of Internal Affairs and Administration;Zelazna Medical Centre; Medical Faculty od Lazarski University;Fundación Para la Investigación y el Desarrollode la Medicina Materno-Fetal y Neonatal "iMaterna";Karolinska Institutet;Taiji Clinic, Taipei;Taiji Clinic, Taipei;Chang Gung University;Wayne State University;Wayne State University;University of Medicine, Tirana;Royal Prince Alfred Hospital, Sydney;Charles University;Université de Paris;Charite University, Berlin, Germany;Chinese University of Hong Kong;Meir Medical Center;Meir Medical Center;Università degli Studi di Brescia;American University of Beirut Medical Center;Karolinska Institutet;The Arctic University of Norway;The Arctic University of Norway;The Arctic University of Norway;Karolinska Institutet; |
<br> Inclusion Criteria:
<br>
<br> - declaration of being pregnant
<br>
<br> - being able to complete the survey in the available languages
<br>
<br> - answer the screening questions
<br>
<br> - provide informed consent for participation
<br>
<br> Exclusion Criteria:
<br>
<br> - not providing online informed consent for participation
<br>
<br> - if the participant does not click on the submit button at the end of the survey
<br>
<br> - not answer all the GAD-7 and PHQ-9 scale questions
<br> | | Anxiety;Depression;Pregnancy Related | Other: Pandemic control measures | Anxiety;Depression | | | | Yes | False | | |
| NCT04377425 | 12 December 2020 | COVID-19 Prevalence and Cognitive Deficits in Neurological Patients | COVID-19 Prevalence, Morbidity and Long Term Cognitive Deficits in Consecutive Patients Presenting With Acute Neurological Symptoms | Neuro-Covid | Aarhus University Hospital | 29/04/2020 | 20200429 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04377425 | Not recruiting | No | 18 Years | N/A | All | May 7, 2020 | 0 | Observational | | | Denmark | | Grethe Andersen, MD | | | | Aarhus University Hospital |
<br> Eligibility criteria for the extended study:
<br>
<br> Inclusion Criteria:
<br>
<br> - Adult patients
<br>
<br> - New onset of neurological symptoms
<br>
<br> - Independent in daily activities (modified Rankin Scale = 2)
<br>
<br> - Stroke or epilepsy/seizure
<br>
<br> Exclusion Criteria:
<br>
<br> - Pre-existing neurodegenerative disease
<br>
<br> - Diagnosed with cerebral neoplasm
<br>
<br> - Pre-existing expected life expectancy < 3 months
<br>
<br> - Suspected non-organic (functional) disorder
<br> | | Neurological Diseases or Conditions;Stroke, Acute;Seizure Disorder | Diagnostic Test: COVID-19 swap test PCR | Prevalence of COVID-19 infection in consecutive patients with neurological symptoms | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04377997 | 12 December 2020 | Safety and Efficacy of Therapeutic Anticoagulation on Clinical Outcomes in Hospitalized Patients With COVID-19 | A Randomized, Open-Label Trial of Therapeutic Anticoagulation in COVID-19 Patients With an Elevated D-Dimer | | Massachusetts General Hospital | 01/05/2020 | 20200501 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04377997 | Not recruiting | No | 18 Years | N/A | All | May 15, 2020 | 300 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | | ; | Mazen Albaghdadi, MD;Mazen Albaghdadi, MD | | ;MALBAGHDADI@mgh.harvard.edu | ;617-726-7400 | Massachusetts General Hospital; |
<br> Inclusion:
<br>
<br> - COVID-19 positive on admission or during hospitalization (having been tested within
<br> the past 5 days) with symptoms consistent with COVID-19 including fever (= 38C,
<br> 100.4F), pneumonia, symptoms of lower respiratory illness (e.g., cough, difficulty
<br> breathing), loss of smell or taste, myalgias, pharyngitis, or diarrhea
<br>
<br> - Admitted to the regular medical floor or intensive care unit (ICU) without severe ARDS
<br> (P/F ratio<100)
<br>
<br> - Elevated D-dimer (>1.5g/mL)
<br>
<br> - Age>18 years and not older than 90
<br>
<br> - Fibrinogen >100
<br>
<br> - Platelets >50,000
<br>
<br> - No prior intracranial hemorrhage or recent ischemic stroke or TIA within 6 months
<br>
<br> - D-dimer > 1500 ng/ml
<br>
<br> - No other clinical indication for therapeutic anticoagulation (e.g., deep vein
<br> thrombosis [DVT], pulmonary embolism [PE], atrial fibrillation, acute coronary
<br> syndromes, or extracorporeal membrane oxygenation)
<br>
<br> Exclusion:
<br>
<br> - Disseminated intravascular coagulation (DIC) according to the International Society on
<br> Thrombosis and Hemostasis overt DIC definition
<br>
<br> - Hemoglobin (Hgb) <8 g/dl
<br>
<br> - Hypersensitivity to heparin or heparin formulation including heparin-induced
<br> thrombocytopenia
<br>
<br> - Thrombocytopenia: platelets<50,000 platelets/ul
<br>
<br> - Uncontrolled or active/recent bleeding including intracranial hemorrhage, signs of
<br> active bleeding (e.g., blood transfusion within 30 days), any GI bleed within the past
<br> 6 months, or internal bleeding within the past 1 month
<br>
<br> - High bleeding risk: significant closed-head or facial trauma within 3 months,
<br> traumatic or prolonged CPR (>10min), or use of dual anti-platelet therapy
<br>
<br> - Known or suspected pregnancy
<br>
<br> - Recent (<48 hours) or planned spinal or epidural anesthesia or puncture
<br>
<br> - If the patient is on other anticoagulants, antihistamines, nonsteroidal
<br> anti-inflammatory drugs (i.e. aspirin) or hydroxychloroquine
<br>
<br> - Uncontrolled hypertension
<br> | | Cardiovascular Diseases;COVID-19 | Drug: Enoxaparin | Number of patients with a major bleeding event according to the International Society on Thrombosis and Haemostasis (ISTH) definition.;Number of patients with the composite efficacy endpoint of death, cardiac arrest, symptomatic deep venous thrombosis, pulmonary embolism, arterial thromboembolism, myocardial infarction, or hemodynamic shock. | | | | Yes | False | | |
| → | NCT04378257 | 12 December 2020 | Efficacy of Therapist Guided e-Therapy Versus Self-Help Therapy on Psychological Distress Among Individuals in Oman During COVID-19 Pandemic | Efficacy of Therapist Guided e-Therapy Versus Self-Help Therapy on Psychological Distress Among Individuals in Oman During COVID-19 Pandemic: An Open-Label 12 - Weeks Randomized Controlled Trail | | Sultan Qaboos University | 02/05/2020 | 20200502 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04378257 | Not recruiting | No | 18 Years | 65 Years | All | June 1, 2020 | 70 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | | | Mohammed Al Alawi, MD | | alalawim@squ.edu.om | +14379725277 | |
<br> Inclusion Criteria:
<br>
<br> - All Omanis and Non-Omanis living in Oman, Male or female aging 18-65 years, with PHQ-9
<br> or GAD -7 total scores = 10.
<br>
<br> - Has access to the internet and video conferencing.
<br>
<br> - Able to participate in the trial and adhere to the trial protocol.
<br>
<br> - Can provide a written informed consent to participate in the trial.
<br>
<br> Exclusion Criteria:
<br>
<br> - Pre-existing mental disorders.
<br>
<br> - Diagnosis of moderate to severe intellectual disability.
<br>
<br> - Presence of alcohol or other substance use disorders (except for nicotine or
<br> caffeine).
<br>
<br> - Those who does not meet the inclusion criteria.
<br>
<br> - Those with suicidal or homicidal ideation at baseline.
<br> | | Depressive Symptoms;Generalized Anxiety | Behavioral: Therapist Guided E-Therapy;Behavioral: Self-Help Therapy | Change in Anxiety symptoms measured by Generalized Anxiety Disorder-7;Change in Depressive symptoms measured by Patient Health Questionnaire-9→Change in Depressive symptoms measured by Patient Health Questionnaire-9;Change in Anxiety symptoms measured by Generalized Anxiety Disorder-7 | | | | Yes | False | | |
| NCT04378582 | 12 December 2020 | Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU | Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU | EpiCoV-Brazil | University of Sao Paulo General Hospital | 05/05/2020 | 20200505 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04378582 | Not recruiting | No | 14 Years | 100 Years | All | May 7, 2020 | 1589 | Observational | | | Brazil | | Juliana C Ferreira, MD | | | | University of Sao Paulo - hospital das Clínicas da faculdade de medicina da USP (HCFMUSP) |
<br> Inclusion Criteria:
<br>
<br> - Being admitted to one of the COVID-19 ICUs during the study period
<br>
<br> - Suspected or confirmed COVID-19
<br>
<br> - Expected ICU stay greater than 24 hours
<br>
<br> Exclusion Criteria:
<br>
<br> - ICU Readmission during the same hospital stay (patients will be evaluated only during
<br> their first ICU stay)
<br> | | SARS-CoV 2;Respiratory Distress Syndrome, Adult;Corona Virus Infection;Critical Illness | Other: risk factors | ICU survival at 28 days | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04378881 | 12 December 2020 | Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Adults With Polypharmacy Using Data From Large Medicare and Commercially Insured Populations | Simulation of Risk of Adverse Drug Events Associated With the Initiation of Drugs Repurposed for the Treatment of COVID-19 in Adults With Polypharmacy Using Data From Large Medicare and Commercially Insured Populations | | Tabula Rasa HealthCare | 05/05/2020 | 20200505 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04378881 | Not recruiting | No | 18 Years | N/A | All | June 1, 2020 | 100 | Observational | | | United States | | Veronique Michaud | | | | Tabula Rasa HealthCare |
<br> Inclusion Criteria:
<br>
<br> - Patients enrolled with Cambia Health Solutions; Medicare/Medicaid or Commercial Health
<br> Insurance Plan
<br>
<br> - Patients with drug claims available from 10/01/2018 to 10/31/2019
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients with no drug claims available for 2018
<br>
<br> - Health Plan for injectable drugs
<br> | | COVID;Drug Effect;Drug Interaction;Adverse Drug Event | | Calculate the Medication Risk Score of de-identified participants from Medicare/Medicaid and commercial health insurance plans using their current drug regimen via our proprietary risk stratification process.;Simulate the Medication Risk Score following the addition of different repurposed drugs against COVID-19 to their current drug regimen via our proprietary risk stratification process.;Compare the impact (change) on the Medication Risk Score using the calculate before score and simulated after score following the addition of repurposed drugs for COVID-19 to the drug regimens of patients enrolled in the study.;Measure the effects of various repurposed drugs for COVID-19 on each of the five factors computed by algorithms to derive the Medication Risk Score will be calculated via our proprietary risk stratification process. | | | | Yes | False | | |
| → | NCT04379063 | 12 December 2020 | COVID-19 Pandemic Short Interval National Survey Gauging Psychological Distress | COVID-19 Pandemic Short Interval National Survey Gauging Psychological Distress Among Physicians (COPING Survey): A Longitudinal Survey | COPING | Jon Bailey | 05/05/2020 | 20200505 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04379063 | Not recruiting | No | N/A | N/A | All | May 13, 2020 | 342 | Observational | | | Canada | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Any physician who is currently practicing in Canada, whether they hold a full,
<br> provisional, or post-graduate in-training license.
<br>
<br> Exclusion Criteria:
<br>
<br> - Non-physician healthcare providers, medical students, physicians without an active
<br> license to practice will be excluded.
<br> | | Burnout, Professional;Psychological Distress | Other: COVID-19 pandemic | Psychological Distress;Burnout→Burnout;Psychological Distress | | | | Yes | False | | |
| NCT04379232 | 12 December 2020 | Surgical Activity During the Covid-19 Pandemic: Results for 112 Patients in a French Tertiary Care Center | Surgical Activity During the Covid-19 Pandemic: Results for 112 Patients in a French Tertiary Care Center: A Retrospective Observational Cohort Study | SurgiCovid | Hospices Civils de Lyon | 04/05/2020 | 20200504 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04379232 | Not recruiting | No | 18 Years | N/A | All | March 19, 2020 | 112 | Observational | | | France | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - surgical management
<br>
<br> - > 18 years old
<br>
<br> Exclusion Criteria:
<br>
<br> - < 18 years old
<br> | | Digestive Cancer;Gynaecological Cancer;Head and Neck Cancer | Biological: Screening test for covid ( RT PCR and CT Chest) | Symptoms of Covid after surgery | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04398303 | 12 December 2020 | ACT-20 in Patients With Severe COVID-19 Pneumonia | A Phase 1/2 Randomized, Placebo-Controlled Trial of ACT-20 in Patients With Severe COVID-19 Pneumonia | | Aspire Health Science | 20/05/2020 | 20200520 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04398303 | Not recruiting | No | 18 Years | 85 Years | All | May 2020 | 70 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 1/Phase 2 | | | Laura Fairbairn | | regulatory@aspire2cure.com | 403-921-5854 | |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female patients age 18 to 85, inclusive
<br>
<br> 2. Confirmed positive test for COVID-19 by standard reverse transcriptase polymerase
<br> chain reaction (RT-PCR) assay or equivalent
<br>
<br> 3. On mechanical ventilation (n=35), or high-flow O2 support (n=35) and:
<br>
<br> 1. Disease severity level of "moderate" (PaO2/FiO2 of 100-200) (n=35), or "severe"
<br> (PaO2/FiO2 < 100) (n=35) as established using the Berlin Criteria for ARDS
<br> (Barbas, Isola & Caser, 2014; Baron & Levy, 2016).
<br>
<br> 2. Positive end-expiratory airway pressure (PEEP) = 5 cmH2O
<br>
<br> 3. Oxygen saturation = 93%
<br>
<br> 4. Non-cardiogenic bilateral pulmonary edema on frontal chest radiograph that cannot be
<br> explained by effusion, collapsed lung or lung nodule
<br>
<br> 5. Able to understand and provide voluntary informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Unable to understand and provide voluntary informed consent
<br>
<br> 2. Current infection with HIV-1, HIV-2, Hepatitis B, Hepatitis C or HTLV
<br>
<br> 3. History of malignancy, other than non-melanoma skin cancer or non-metastatic prostate
<br> cancer
<br>
<br> 4. Currently receiving extracorporeal life support or high-frequency oscillatory
<br> ventilation
<br>
<br> 5. Weight > 150 kg
<br>
<br> 6. Current severe chronic respiratory disease, as demonstrated by:
<br>
<br> 1. PaCO2 > 50 mm Hg, or
<br>
<br> 2. history of use of home oxygen
<br>
<br> 7. Major trauma within the past 7 days
<br>
<br> 8. Lung transplant recipient
<br>
<br> 9. WHO Class III or IV pulmonary hypertension
<br>
<br> 10. Documented deep vein thrombosis or pulmonary embolism within the past 3 months
<br>
<br> 11. Currently pregnant or lactating
<br>
<br> 12. Currently participating in another clinical trial, or participation in another
<br> clinical trial within 30 days of enrollment
<br>
<br> 13. Hypersensitivity to Dextran-40 or Dimethyl Sulfoxide (DMSO)
<br>
<br> 14. Current pharmacotherapy using hydroxychloroquine or Interleukin-6 inhibitors
<br>
<br> 15. History of CVA or MI within 180 days of study enrollment
<br> | | COVID-19 Pneumonia | Biological: ACT-20-MSC;Biological: ACT-20-CM;Biological: Placebo | Mortality at day 30 | | | | Yes | False | | |
| → | NCT04399005 | 12 December 2020 | The Efficacy Comparing Daily and After-each-case Room Disinfection. | The Efficacy Comparing Daily and After-each-case Room Disinfection in the Endoscopy Unit During the COVID-19 Pandemic. | | The First Affiliated Hospital of Zhejiang Chinese Medical University | 19/05/2020 | 20200519 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04399005 | Not recruiting | No | N/A | N/A | All | May 25, 2020 | 240 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor). | N/A | China | | Bin Lu | | | | First Affiliated Hospital of Zhejiang Chinese Medical University |
<br> Inclusion Criteria:
<br>
<br> - All the cases received gastroscopy.
<br>
<br> Exclusion Criteria:
<br>
<br> - High-risk personal through contact history, symptoms, body temperature, COVID-19 virus
<br> nucleic acid testing and chest computed tomography (CT) scan.
<br> | | Daily Room Disinfection;After-each-case Room Disinfection | Other: after-each-case room disinfection;Other: daily room disinfection | The number of colony-forming units (CFU);Qualified rate of room disinfection→Qualified rate of room disinfection;The number of colony-forming units (CFU) | | | | Yes | False | | |
| NCT04399109 | 12 December 2020 | Evaluation of a Remote Monitoring Smartphone Application and Care Model of COVID-19 Patients in the Community (ReCOVER) | ReCOVER (Remote COVID-19 Evaluation and Response): a Prospective Non-randomised Controlled Trial to Evaluate the Effect of a Novel Smartphone Application-centric Model of Care for the Remote Monitoring of COVID-19 Patients in the Community. | ReCOVER | Dr Sze-Yuan Ooi | 21/05/2020 | 20200521 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04399109 | Recruiting | No | 18 Years | N/A | All | May 20, 2020 | 2000 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | Australia | ; | Sze-Yuan Ooi;Sze-Yuan Ooi | | ;SzeYuan.Ooi@ehc.com.au | ;+61293820700 | Prince of Wales Hospital; |
<br> Inclusion Criteria:
<br>
<br> 1. Age greater or equal to 18 years
<br>
<br> 2. Able to provide informed consent
<br>
<br> 3. Proven diagnosis of COVID-19 based on positive virology testing
<br>
<br> 4. Patients who are being managed at home OR those who are being discharged from hospital
<br> for ongoing home-based care in isolation.
<br>
<br> 5. Access to a smartphone or device that is compatible with the TCC-COVID app
<br>
<br> - Any iPhone or iPad running iOS 9 or above (essentially any iPhone 5 or above)
<br>
<br> - Any Android phone that is operating Android 7.0 or above
<br>
<br> 6. Speaks adequate English
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patient meets clinical criteria for hospital-based care.
<br>
<br> 2. Inability to use the TCC-COVID app and pulse oximeter due to reasons including but not
<br> limited to:
<br>
<br> - Cognitive impairment
<br>
<br> - Impaired dexterity
<br>
<br> - Visual impairment
<br>
<br> - Language barrier
<br>
<br> 3. Patient residing outside the SESLHD catchment area during their period of isolation
<br> | | COVID | Device: TCC-COVID mHealth solution | Rate of avoidable Emergency Department presentations per diagnosed COVID-19 case;All cause mortality per diagnosed COVID-19 case All-cause mortality rate at 30 days per diagnosed COVID-19 case | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04425707 | 12 December 2020 | Ivermectin In Treatment of COVID 19 Patients | The Use of Ivermectin In the Treatment of COVID 19 Patients | | Ministry of Health and Population, Egypt | 08/06/2020 | 20200608 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04425707 | Recruiting | No | 18 Years | N/A | All | June 9, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Egypt | ; ; | houssam ho masoud, MD;ehab ah kamal, MD;ehab ah kamal, MD | | ;ehabkamal2011@hotmail.com; | ;01006162663;01006162663 | COVID sceintific comittee ministry of health and population; |
<br> Inclusion Criteria:
<br>
<br> - Asymptomatic mild cases and moderate cases proven to be infected by COVID 19 by viral
<br> RNA swap
<br>
<br> Exclusion Criteria:
<br>
<br> - Contraindications for the drug: hypersensitivity.
<br>
<br> - Any medications with possible drug interactions.
<br>
<br> - Severe cases.
<br>
<br> - Any malignant condition.
<br>
<br> - Pregnant females.
<br>
<br> - Breast feeding females.
<br>
<br> - Any patient on the following medications: Erdafitinib- Lasmiditan- Quinidine due to
<br> potential severe drug interaction.
<br> | | Covid19 | Drug: Ivermectin | to evaluate the role of Ivermectin as a line of treatment for COVID 19 | | | | Yes | False | | |
| → | NCT04425733 | 12 December 2020 | MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia (MK-5475-009) | A Study to Assess the Safety, Tolerability, and Pharmacodynamics of Multiple Dose MK-5475 in Participants With Hypoxemia Due to COVID-19 Pneumonia | | Merck Sharp & Dohme Corp. | 08/06/2020 | 20200608 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04425733 | Not recruiting | No | 18 Years | 80 Years | All | July 7, 2020 | 0 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 1 | | | Medical Director | | | | Merck Sharp & Dohme Corp. |
<br> Inclusion Criteria:
<br>
<br> - Has virologically confirmed COVID-19 requiring hospital admission.
<br>
<br> - Has respiratory symptoms including cough and dyspnea
<br>
<br> - Requires supplemental oxygen therapy
<br>
<br> - Male participant is abstinent from heterosexual intercourse or agrees to use
<br> contraception during the intervention period and for at least 14 days, corresponding
<br> to time needed to eliminate study intervention(s) (example, 5 terminal half-lives
<br> after the last dose of study intervention)
<br>
<br> - Female participant is not a woman of childbearing potential (WOCBP) or is a WOCBP who
<br> is abstinent from heterosexual intercourse or using contraception during the
<br> intervention period and for at least 14 days, corresponding to time needed to
<br> eliminate study intervention(s) (example, 5 terminal half-lives after the last dose of
<br> study intervention)
<br>
<br> Exclusion Criteria:
<br>
<br> - Has pre-existing medical conditions of any nature which are immediately pre-terminal
<br> such as death or limitation of life-sustaining therapy is expected to be imminent
<br>
<br> - Requires or is expected to require invasive mechanical ventilation
<br>
<br> - Requires or is expected to require noninvasive mechanical ventilation
<br>
<br> - Has any issue which would prohibit them from effective use of the MK-5475 inhaler
<br>
<br> - Hypoxemia which is explained by any condition other than COVID-19, example,
<br> preexisting cardiac or pulmonary disease
<br>
<br> - Has severe hepatic impairment (meets Child-Pugh Class C criteria)
<br>
<br> - Has severe renal impairment and/or requirement for renal dialysis
<br> | | Coronavirus Disease 2019 (COVID-19);Pneumonia;Hypoxemia | Drug: MK-5475;Drug: Placebo | Number of Participants Who Experience an Adverse Event (AE);Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE);Change From Baseline to Day 1 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 2 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 3 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 4 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 5 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 6 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 7 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2)→Change From Baseline to Day 7 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 6 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 5 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 4 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 3 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 2 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Change From Baseline to Day 1 in the Time-weighted Average from 0 through 24 hours (TWA0-24hrs) for the Ratio of Blood Oxygen Saturation to the Fraction of Inspired Oxygen (SpO2/FiO2);Number of Participants Who Discontinued Study Drug Due to an Adverse Event (AE);Number of Participants Who Experience an Adverse Event (AE) | | | | Yes | False | | |
| NCT04425759 | 12 December 2020 | Prevalence and Risk Factors of SARS-CoV-2 Antibody Responses (COVID-19) | Prevalence and Risk Factors of SARS-CoV-2 Antibody Responses and Assymptomatic Carriers Among a Cohort of 2,300 Healthcare Workers at the Consorci Sanitari Del Maresme (CSdM) | SERO-MARES | Hospital de Mataró | 08/06/2020 | 20200608 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04425759 | Recruiting | No | 18 Years | N/A | All | June 8, 2020 | 2400 | Observational [Patient Registry] | | | Spain | ; ; | Pere Clavé, MD, PhD;Pere Clavé, MD, PhD;Pere Clavé, MD | | ;pere.clave@ciberehd.org;pere.clave@ciberehd.org | ;+34937417700;937417700 | Hospital de Mataró; |
<br> Inclusion Criteria:
<br>
<br> - All the professionals working at the Consorci Sanitari del Maresme (approximately 2300
<br> subjects).
<br>
<br> Exclusion Criteria:
<br>
<br> - None.
<br> | | Covid19;Corona Virus Infection;SARS-CoV 2;COVID | Diagnostic Test: Blood sample | Antibodies to SARS-CoV2: IgA, IgM, IgG;PCR of nasopharyngeal smears on all IgM + | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04427098 | 12 December 2020 | Enoxaparin in COVID-19 Moderate to Severe Hospitalized Patients | Intermediate Dose Enoxaparin in Hospitalized Patients With Moderate-severe COVID19: A Pilot Phase II Single-arm Study, INHIXACOVID19 | INHIXACOV19 | Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi | 29/05/2020 | 20200529 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04427098 | Recruiting | No | 18 Years | 90 Years | All | May 22, 2020 | 300 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | Italy | ; | Pierluigi Viale, MD;Andrea Romagnoli, MD | | ;aromagnoli@ricerchenuove.com | ;0039 050 0984040 | Infectious Diseases Unit, Dep. Med. and Surg. Science University of Bologna; |
<br> Inclusion Criteria:
<br>
<br> - For both interventional study and observational cohort, hospitalized patients are
<br> eligible to be included if the following criteria apply:
<br>
<br> Inclusion criteria:
<br>
<br> - Age >=18 y
<br>
<br> - Microbiologically confirmed COVID-19 infection
<br>
<br> - Patients with moderate to severe disease according to study definitions (see below)
<br>
<br> - Informed consent to participate and to use data for interventional study, only to use
<br> data for observational cohort
<br>
<br> Exclusion Criteria:
<br>
<br> - Participants are excluded from the interventional study if any of the following
<br> criteria apply:
<br>
<br> - Thrombocytopenia (platelet count < 50.000 mm3)
<br>
<br> - Coagulopathy: INR (International normalized ratio) >1.5, aPTT ratio >1.4
<br>
<br> - Impaired renal function (clearance to creatinine less than 15 ml/min)
<br>
<br> - Known hypersensitivity to heparin
<br>
<br> - History of heparin induced thrombocytopenia
<br>
<br> - Presence of an active bleeding or a pathology susceptible of bleeding in presence
<br> of anticoagulation (e.g. recent haemorrhagic stroke, peptic ulcer, malignant
<br> tumors at hig risk of haemorrhages, recent neurosurgery or ophthalmic surgery,
<br> vascular aneurysms, arteriovenous malformations)
<br>
<br> - Body weight <45 or > 150 kg
<br>
<br> - Concomitant anticoagulant treatment for other indications ( eg atrial
<br> fibrillation, venous thromboembolism , prosthetic heart valves).
<br>
<br> - Dual antiplatelet therapy
<br>
<br> - Pregnant or breast-feeding women
<br> | | COVID-19 | Drug: Enoxaparin 40 Mg/0.4 mL Injectable Solution;Drug: Enoxaparin | To investigate the efficacy of enoxaparin in improving the clinical outcome of hospitalized patients with moderate-severe COVID-19.;To investigate the efficacy of enoxaparin in improving the clinical outcome of hospitalized patients with moderate-severe COVID-19.;To investigate the efficacy of enoxaparin in improving the clinical outcome of hospitalized patients with moderate-severe COVID-19.;To investigate the efficacy of enoxaparin in improving the clinical outcome of hospitalized patients with moderate-severe COVID-19. | | | | Yes | False | | |
| → | NCT04427176 | 12 December 2020 | Evaluation of ARFC Masks Equipped With CF5 Filter in the Care Unit to Allow a Wider Distribution of FFP2 Masks (Covid-19). | Evaluation of ARFC Masks Equipped With CF5 Filter in the Care Unit to Allow a Wider Distribution of FFP2 Masks (Covid-19). | Masq-Aute | Centre Hospitalier Universitaire de Saint Etienne | 10/06/2020 | 20200610 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04427176 | Not recruiting | No | 18 Years | N/A | All | April 29, 2020 | 15 | Observational | | | France | | Jean-Luc PERROT, MD PhD | | | | CHU SAINT-ETIENNE |
<br> Inclusion Criteria:
<br>
<br> - Nursing staff working 8 or 12 hours a day for 2 consecutive days in a COVID unit at
<br> the hospital of Saint Etienne.
<br>
<br> - Subjects affiliated to or entitled to a social security scheme
<br>
<br> - Subject who received informed information about the study and agreed to participate in
<br> the study
<br>
<br> Exclusion Criteria:
<br>
<br> - Allergy to ARCF mask material: polyurethane
<br>
<br> - Impossibility of supporting a tight mask on the face
<br>
<br> - Potential contraindication to wearing a mask, such as the existence of claustrophobia
<br>
<br> - Beard and moustache wearer
<br>
<br> - Suspicion of COVID-19 infection
<br>
<br> - Refusal to participate.
<br> | | Nurse | Device: ARFC mask | Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of compatibility with technical gestures.;Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of tolerance→Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of tolerance;Evaluate the feasibility of the use of an ARFC mask by nursing staff, in terms of compatibility with technical gestures. | | | | Yes | False | | |
| NCT04427267 | 12 December 2020 | Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients | Assessment of Thermal Condition of Health Workers Who Use Personal Protective Equipment for Biological Factors During Their Work With COVID-19 Patients | | Federal State Budgetary Scientific Institution "Izmerov Research Institute of Occupational Health" | 10/06/2020 | 20200610 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04427267 | Not recruiting | No | 18 Years | 45 Years | All | June 3, 2020 | 6 | Observational | | | Russian Federation | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - healthy individuals (based on medical screening)
<br>
<br> Exclusion Criteria:
<br>
<br> - endocrinological diseases and disorders
<br>
<br> - health deviations at the time of the study
<br> | | Thermal Condition of Health Workers Who Use Personal Protective Equipment From Biological Hazards During Their Work With COVID-19 Patients | Other: Personal protective equipment from biological hazard | Skin thermometry;Hygrometry under costume;Heart rate;Air thermometry;Air hygrometry | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04437901 | 12 December 2020 | COVIDAR - Arrhythmias in COVID-19 | COVIDAR - International Registry on Arrhythmias in COVID-19 | COVIDAR | Hospital Clinic of Barcelona | 28/05/2020 | 20200528 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04437901 | Not recruiting | No | N/A | N/A | All | June 2020 | 10000 | Observational [Patient Registry] | | | Belgium;Italy;Netherlands;Spain;United Kingdom;Belgium;Italy;Netherlands;Spain;United Kingdom | ; ; ; ; ; | Elena Arbelo, MD, PhD, MSc;Arthur A Wilde, MD, PhD;Lia Crotti, MD, PhD;Elijah Behr, MD, PhD;Hein Heidbuchel, MD, PhD;Elena Arbelo, MD, PhD | | ;;;;;EARBELO@clinic.cat | ;;;;;+34 93 227 5551 | Hospital Clinic of Barcelona;Amsterdam UMC;Istituto Auxologico Italiano, IRCCS;St George's University Hospitals NHS Foundation Trust;University Hospital, Antwerp; |
<br> Inclusion Criteria:
<br>
<br> - Patients admitted with highly suspected/confirmed infection with SARS-CoV-2.
<br>
<br> Exclusion Criteria:
<br>
<br> - Formal opposition by the patient to data collection.
<br> | | COVID;Arrhythmia;Torsades de Pointe Caused by Drug;Qt Interval, Variation in;Atrioventricular Block;Atrial Fibrillation;Bradyarrhythmia;Ventricular Arrythmia | | Arrhythmia | | | | Yes | False | | |
| → | NCT04438057 | 12 December 2020 | Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19 | Evaluating the Efficacy of Convalescent Plasma in Symptomatic Outpatients Infected With COVID-19 | | Metro Infectious Disease Consultants | 17/06/2020 | 20200617 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04438057 | Recruiting | No | 18 Years | N/A | All | August 12, 2020 | 150 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | | Nicholas Van Hise, PharmD | | nvanhise@midcusa.com | 630-655-6952 | |
<br> Inclusion Criteria:
<br>
<br> - Laboratory confirmed diagnosis of infection with SARS-CoV-2
<br>
<br> - Symptoms of COVID -19 - cough, fever, sore throat, SOB, anosmia, diarrhea, myalgia
<br>
<br> - Symptoms less than 14 days
<br>
<br> - ID Physician determination that the patient does not need hospitalization
<br>
<br> - O2 saturation of >93%
<br>
<br> - Informed consent provided by the patient or healthcare proxy
<br>
<br> - Age = 18 years
<br>
<br> - Ambulatory Outpatient when informed consent obtained and study drug is administered
<br>
<br> Exclusion Criteria:
<br>
<br> - Age < 18 y/o
<br>
<br> - Patients currently receiving intravenous immunoglobulin
<br>
<br> - Hypercoagulable state - neoplasia, Collagen vascular disease, Myelodysplastic
<br> syndrome, chronic anticoagulation treatment, etc.
<br>
<br> - Need to be hospitalized
<br>
<br> - O2 sat < 93%
<br>
<br> - D-Dimer > 2x normal
<br>
<br> - Chronic oxygen therapy
<br>
<br> - Renal insufficiency with Creatinine clearance < 30
<br>
<br> - Long term care or assisted living facility resident
<br>
<br> - Ongoing usage of hydroxychloroquine for any indication
<br>
<br> - History of blood or plasma transfusion related complications
<br>
<br> - Enrollment into any other investigational drug or device study within the previous 30
<br> days
<br>
<br> - Any drug, chemical or alcohol dependency as determined by the investigator through
<br> history that may affect study procedures and follow up
<br>
<br> - Pregnant or breast feeding
<br>
<br> - Any acute or chronic medical comorbidity, psychiatric, social or other circumstance
<br> that, in the opinion of the investigator, may interfere with study compliance,
<br> completion, or accurate assessment of the study outcomes/safety
<br>
<br> - Admitted to or expected to be admitted to a medical facility
<br> | | COVID-19 | Biological: CCP | SAEs within 24 hours of plasma infusion;Time to Resolution of Symptoms→Time to Resolution of Symptoms;SAEs within 24 hours of plasma infusion | | | | Yes | False | | |
| NCT04438070 | 12 December 2020 | COVID Screening Strategies in Homeless Shelters | COVID Screening Strategies in Homeless Shelters | | St. Joseph's Healthcare Hamilton | 17/06/2020 | 20200617 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04438070 | Recruiting | No | 18 Years | N/A | All | April 10, 2020 | 400 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label). | N/A | Canada | ; | Timothy O'Shea, MD;Timothy O'Shea, MD | | osheat@mcmaster.ca;osheat@mcmaster.ca | 905-521-2100;905-521-2100 | |
<br> Inclusion Criteria:
<br>
<br> - Age greater than or equal to 18
<br>
<br> - Able to provide oral consent
<br>
<br> - Able to perform a self-collected swab if in the relevant intervention arm
<br>
<br> Exclusion Criteria:
<br>
<br> -
<br> | | COVID-19 | Diagnostic Test: COVID-19 Swab | COVID-19 Detection Rate | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04443764 | 12 December 2020 | Status and Predictors of Mental Health Symptoms Among Migrants and Refugees During the COVID-19 Pandemic | Status and Predictors of Mental Health Symptoms Among Migrants and Refugees During the COVID-19 Pandemic | | University of Oslo | 19/06/2020 | 20200619 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04443764 | Not recruiting | No | 18 Years | N/A | All | June 22, 2020 | 287 | Observational | | | | ; ; ; ; | Sverre Urnes Johnson, PhD;KariAnne Vrabel, PhD;Omid Ebrahimi, Mr;Asle Hoffart, PhD;Sverre Urnes Johnson, PhD | | ;;;;s.u.johnson@psykologi.uio.no | ;;;;41633313 | University of Oslo & Modum Bad;Modum Bad;University of Oslo & Modum Bad;Modum Bad & University of Oslo; |
<br> Inclusion Criteria:
<br>
<br> - Eligible participants are all refugees, first generation, and second generation
<br> migrants.
<br>
<br> - Adults including those of 18 years and above
<br>
<br> - Who are currently living in Norway and thus experiencing identical NPIs, and
<br>
<br> - Who had provided digital consent to partake in the study.
<br>
<br> Exclusion Criteria:
<br>
<br> - Children and adolescents (individuals below 18)
<br>
<br> - Adults not residing in Norway during the measurement period
<br>
<br> - Those not defined as vulnerable health-care professionals or public servide providers
<br> (see definition above)
<br> | | Migrants;Anxiety;Depression | | Health Anxiety Symptoms;Generalized Anxiety Disorder 7;Patient Health Questionnaire 9 | | | | Yes | False | | |
| → | NCT04444115 | 12 December 2020 | Loneliness During Strict and Lifted Social Distancing Protocols Against the COVID-19 Pandemic | Loneliness During the COVID-19 Pandemic: Change and Predictors of Change From Strict to Lifted Social Distancing Protocols | | Modum Bad | 20/06/2020 | 20200620 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04444115 | Not recruiting | No | 18 Years | N/A | All | June 22, 2020 | 10084 | Observational | | | | ; ; ; | Omid Ebrahimi, Cand Psychol;Asle Hoffart, PhD;Sverre Urnes Johnson, PhD;Asle Hoffart, PhD | | ;;;asle.hoffart@modum-bad.no | ;;;+4790594733 | University of Oslo and Modum Bad;Modum Bad and University of Oslo;University of Oslo and Modum Bad; |
<br> Inclusion Criteria:
<br>
<br> - all adults residing in Norway
<br>
<br> Exclusion Criteria:
<br>
<br> - none
<br> | | Loneliness During COVID-19 | | Generalized Anxiety Disorder-7 (GAD-7);Patient Health Questionnaire-9 (PHQ-9);UCLA Loneliness Scale-8 (ULS-8)→UCLA Loneliness Scale-8 (ULS-8);Patient Health Questionnaire-9 (PHQ-9);Generalized Anxiety Disorder-7 (GAD-7) | | | | Yes | False | | |
| NCT04444271 | 12 December 2020 | Mesenchymal Stem Cell Infusion for COVID-19 Infection | Prospective, Randomized Phase 2 Clinical Trial of Mesenchymal Stem Cells(MSCs) for the Treatment of Coronavirus Disease 2019(COVID-19) | | Dr. Zaineb Akram | 27/05/2020 | 20200527 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04444271 | Recruiting | No | 10 Years | N/A | All | May 1, 2020 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | Pakistan | ; ; | xanab akram;xanab akram;Xanab Akram | | ;xanab.akram@gmail.com; | ;03325346564;03325346564 | NIBMT; |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female, aged = 10years
<br>
<br> 2. Laboratory confirmation of COVID19 infection by reverse-transcription polymerase chain
<br> reaction (RT-PCR) from any diagnostic sampling source; and
<br>
<br> 3. Moderate illness: In compliance with the 2019-coronavirus pneumonia diagnosis standard
<br> [according to the novel coronavirus infection pneumonia diagnosis and treatment
<br> program (Trial Implementation Version 6) issued by the National Health and Medical
<br> Commission, and world health organization (WHO) 2019 new coronavirus guidelines
<br> standards]: (A) increased breathing rate (=30 beats / min), difficulty breathing,
<br> cyanosis of the lips; (B) in resting state, means oxygen saturation =93%; (C) partial
<br> pressure of arterial oxygen (PaO2) / Fraction of inspired oxygen (FiO2) =300 mmHg
<br> (1mmHg = 0.133kPa);
<br>
<br> 4. Critically ill : Respiratory failure, Septic Shock, muti-organ dysfunction syndrome
<br> (MODS)
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients with systemic autoimmune diseases
<br>
<br> 2. Not consenting for clinical trial
<br>
<br> 3. Those declared not for resuscitation due to underlying comorbid or current critical
<br> condition
<br> | | COVID-19 | Drug: Mesenchymal stem cells;Other: Placebo | Overall survival | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04458246 | 12 December 2020 | Home-based Aerobic Training Among Adolescents With Chronic Diseases During COVID-19 Pandemic | Online, Home-based, Aerobic Training Program Among Adolescents With Chronic Diseases During COVID-19 Pandemic: A Randomized Controlled Trial | | University of Sao Paulo | 01/07/2020 | 20200701 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04458246 | Recruiting | No | 10 Years | 19 Years | All | July 2020 | 140 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | N/A | Brazil | ; | Bruno Gualano, PhD;Bruno Gualano, Phd | | gualano@usp.br;gualano@usp.br | +55 11 3061-8789;551130918783 | |
<br> Inclusion Criteria:
<br>
<br> Diagnosed with either one of the following chronic conditions:
<br>
<br> - Inflammatory bowel disease;
<br>
<br> - autoimmune hepatitis;
<br>
<br> - liver transplant;
<br>
<br> - renal transplant;
<br>
<br> - systemic lupus erythematosus;
<br>
<br> - juvenile dermatomyositis;
<br>
<br> - juvenile idiopathic arthritis.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients with physical limitations that preclude exercise.
<br>
<br> - Patients diagnosed with COVID-19.
<br>
<br> - Patients diagnosed with mental disorders.
<br> | | Chronic Disease;Chronic Diseases in Adolescence;Chronic Disease of Immune System;Chronic Kidney Diseases | Other: Exercise training group | Safety and efficacy of a home-based exercise training program | | | | Yes | False | | |
| → | NCT04458948 | 12 December 2020 | Open Label Non-comparative Trial of the Combination of Hydroxychloroquine and Azithromycin in the Treatment of Hospitalized Patients | Open Label Non-comparative Trial of the Combination of Hydroxychloroquine and Azithromycin in the Treatment of Hospitalized Patients With Moderate or Severe COVID-19 Infection | | University of New Mexico | 09/06/2020 | 20200609 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04458948 | Not recruiting | No | 18 Years | N/A | All | March 24, 2020 | 10000 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Adults aged >18 years of age with lower respiratory infection with SARSCo2 documented
<br> by a positive RT-PCR in nasopharyngeal sample admitted to the University of New Mexico
<br> Hospital, with an oxygen saturation of less than 94%, on room air, or a respiratory
<br> rate >24 per minute, or HR>125 per minute of a PaO2/FIO2<150.
<br>
<br> 2. Patient with life expectancy >48 hours.
<br>
<br> 3. Pregnant women may be included if deemed necessary. There is insufficient information
<br> regarding the safety of hydroxychloroquine and azithromycin during pregnancy.
<br> Consequently, these medications are not recommended when pregnant or planning to
<br> become pregnant. However, investigators may prescribe hydroxychloroquine and
<br> azithromycin if deemed necessary.
<br>
<br> 4. Azithromycin is excreted in human milk, therefore participants should not breast-feed
<br> whilst taking Azithromycin, because it may cause side effects including diarrhoea and
<br> infection to a baby. It is recommended to discard the milk during treatment and up
<br> until 2 days after discontinuation of treatment. Additionally, hydroxychloroquine
<br> should not be taken whilst breast-feeding. However, investigators may prescribe
<br> hydroxychloroquine and azithromycin if deemed necessary. Page 6 of 23 Version Date:
<br> 04.16.2020
<br>
<br> 5. Adults unable to consent will be included with the consent of their Legally Authorized
<br> Representative (LAR). Assent will be pursued from cognitively impaired participants if
<br> they are able to provide assent. Note that this does not preclude the enrollment of
<br> cognitively impaired participants that cannot provide assent, but would allow those
<br> that can the opportunity to do so.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Prisoners
<br>
<br> 2. Pre-/co-existing medical conditions, including any of the following:
<br>
<br> Known allergy to study drugs. Contraindication to treatment with study drugs,
<br> including retinopathy, and QTc prolongation defined by QTc>450 in males and >470 in
<br> females. Unless, it is the opinion of the treating physician(s) that the benefits to
<br> treat with medications outweigh the risks. Known chronic kidney disease, stage 4 or 5
<br> or receiving dialysis. Glucose-6-phosphate dehydrogenase (G6PD) deficiency.
<br>
<br> 3. Weight <40 kg.
<br>
<br> 4. Current use of: hydrocholoroquine or cardiac medicines of: flecainade, Tambocor;
<br> amiodarone Cordarone, Pacerone; digoxin or Digox, Digitek, Lanoxin; procainamide or
<br> Procan,Procanbid, propafenone, Rythmal.
<br> | | COVID-19 | Drug: Hydroxychloroquine;Drug: Azithromycin | Duration of viral shedding;Evaluation of Fatality Rate;Evaluation of Clinical Response;Evaluation of Length of Hospital Stay→Evaluation of Length of Hospital Stay;Evaluation of Clinical Response;Evaluation of Fatality Rate;Duration of viral shedding | | | | Yes | False | | |
| NCT04459312 | 12 December 2020 | National Covid-19 Surveillance Physicians | National Covid-Surveillance Physicians | NAT-COV-SURV | Heinrich-Heine University, Duesseldorf | 03/07/2020 | 20200703 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04459312 | Recruiting | No | 18 Years | 99 Years | All | June 1, 2020 | 600 | Observational | | | Germany | | Detlef Kindgen-Milles, Prof. | | kindgen-milles@med.uni-duesseldorf.de | 004902118107047 | |
<br> Inclusion Criteria:
<br>
<br> - Qualified as physician
<br>
<br> Exclusion Criteria:
<br>
<br> - none
<br> | | Antibody COVID-19 | Diagnostic Test: Antibody test (SARS-CoV2) | Presence of antibodies against SARS-COV2 | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04513847 | 12 December 2020 | PsoVac: Educational Needs re Vaccines for Biologic Patients With Psoriasis | PsoVac: A Psoriatic Patient-based Survey on the Understanding of the Use of Vaccines While on Biologics During the Covid-19 Pandemic | | Dermatrials Research | 12/08/2020 | 20200812 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04513847 | Not recruiting | No | N/A | N/A | All | August 13, 2020 | 661 | Observational | | | Canada | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - psoriasis patient
<br>
<br> Exclusion Criteria:
<br>
<br> - no exclusions
<br> | | Psoriasis;Covid19 | | Percentage of patients not understanding the interaction of vaccines and their biologic, assessed with voluntary survey. | | | | Yes | False | | |
| → | NCT04514627 | 12 December 2020 | Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With COVID-19 | Neuromodulation With Percutaneous Electrical Nerve Field Stimulation for Adults With COVID-19 | PENFS COVID-19 | Olive View-UCLA Education & Research Institute | 08/07/2020 | 20200708 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04514627 | Recruiting | No | 18 Years | N/A | All | July 13, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | N/A | United States | ; ; | Nader Kamangar, M.D.;Nader Kamangar, M.D.;Nader Kamangar, M.D. | | ;nkamangar@dhs.lacounty.gov;nkamangar@dhs.lacounty.gov | ;747-210-4427;747-210-4427 | Olive View-UCLA Education & Research Institute; |
<br> Inclusion Criteria:
<br>
<br> - Age =18 years at time of signing Informed Consent Form
<br>
<br> - Hospitalized with COVID-19 pneumonia confirmed per WHO criteria (including a positive
<br> PCR of any specimen, e.g., respiratory, blood, urine, stool, other bodily fluid) and
<br> per the investigator, the respiratory compromise is most likely due to COVID-19
<br>
<br> - Patient complaint of dyspnea at the time of presentation to ED or hospital
<br>
<br> - Patient on room air or oxygen supplementation of no greater than 4 liters at rest to
<br> maintaining pulse oximetry of 92% or greater. This can include oxygen supplementation
<br> by any modality (BIPAP, CPAP, HFNC, NRB, NC), with the exception of mechanical
<br> ventilation or ECLS.
<br>
<br> - Signed Informed Consent Form by any patient capable of giving consent, or, when the
<br> patient is not capable of giving consent, by his or her legal/authorized
<br> representative
<br>
<br> - Ability to comply with the study protocol in the investigator's judgment.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who cannot provide informed consent
<br>
<br> - History of surgery involving CN V, VII, IX, or X.
<br>
<br> - Patient on chronic renal dialysis
<br>
<br> - Patients with history of solid organ transplant
<br>
<br> - Patients with underlying seizures disorder
<br>
<br> - Patients with a cardiac pacemaker
<br>
<br> - Patients with any implanted electrical device
<br>
<br> - Patients with dermatologic conditions affecting the ear, face, or neck region (i.e.
<br> psoriasis), or with cuts or abrasions to the external ear that would interfere with
<br> needle placement
<br>
<br> - Patients with hemophilia or other bleeding disorders
<br>
<br> - Patients who are pregnant or breastfeeding
<br>
<br> - Patients with active TB infection
<br>
<br> - Patient already on mechanical ventilation or ECLS
<br>
<br> - Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
<br>
<br> - In the opinion of the investigator, progression to mechanical ventilation, ECLS or
<br> death is imminent and inevitable within the next 24 hours, irrespective of the
<br> provision of treatments
<br>
<br> - Participating in other drug clinical trials
<br>
<br> - ALT or AST > 5 x ULN detected within 24 hours at screening or at baseline (according
<br> to local laboratory reference ranges)
<br>
<br> - ANC < 500/µL at screening and baseline (according to local laboratory reference
<br> ranges)
<br>
<br> - Platelet count < 50,000/µL at screening and baseline (according to local laboratory
<br> reference ranges)
<br>
<br> - Any serious medical condition or abnormality of clinical laboratory tests that, in the
<br> investigator's judgment, precludes the patient's safe participation in and completion
<br> of the study
<br> | | COVID-19 | Device: Auricular percutaneous neurostimulation | Progression to mechanical ventilation, ECLS or death;Hypoxemia via oxygen level, or saturation (SpO2) in percent→Hypoxemia via oxygen level, or saturation (SpO2) in percent;Progression to mechanical ventilation, ECLS or death | | | | Yes | False | | |
| NCT04514705 | 12 December 2020 | Characteristics in Post Covid-19 Patients | Clinical Respiratory Investigation in Post Covid-19 Patients | | Universidade Metodista de Piracicaba | 11/08/2020 | 20200811 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04514705 | Recruiting | No | 18 Years | 80 Years | All | August 11, 2020 | 20 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Brazil | ; | Luiz F Falcão, PhD;Rodrigo S Rocha, Phd | | fabiofalcao29@yahoo.com.br;fisiorocha2000@yahoo.com.br | +559198237-9488;91992340234 | |
<br> Inclusion Criteria:
<br>
<br> - With confirmed diagnosis for SARS-COV-2.
<br>
<br> Exclusion Criteria:
<br>
<br> - With any type of simultaneous pneumopathy.
<br>
<br> - Patients with autoimmune disease
<br>
<br> - People with simultaneous infectious diseases
<br>
<br> - Pregnant women
<br>
<br> - With degenerative diseases of the nervous system or musculoskeletal system
<br> | | Coronavirus Infection | Other: Exercise | Characteristics of lung;Respiratory muscle strength | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04536051 | 12 December 2020 | A Study of a Candidate COVID-19 Vaccine (COV003) | A Randomized, Controlled, Phase III Study to Determine the Safety, Efficacy, and Immunogenicity of the Non-Replicating ChAdOx1 nCoV-19 Vaccine | | University of Oxford | 01/09/2020 | 20200901 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04536051 | Recruiting | No | 18 Years | N/A | All | June 2, 2020 | 10300 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Single (Participant). | Phase 3 | Brazil | ; | Andrew Pollard, Prof;Volunteer Recruitment Coordinator | | ;vaccinetrials@ndm.ox.ac.uk | ;01865 611424 | University of Oxford; |
<br> Inclusion Criteria:
<br>
<br> - Adults from 18 to 55 years of age
<br>
<br> - Adults aged 56-69 years old (after review of safety data by DSMB in this age group in
<br> the UK trial)
<br>
<br> - Adults aged 70 and above years old (after review of safety data by DSMB in this age
<br> group in the UK trial)
<br>
<br> - Able and willing (in the Investigator's opinion) to fulfill all study requirements;
<br>
<br> - Health professionals and adults at high risk of exposure to SARS-CoV-2, as defined in
<br> section 5.2 of this protocol;
<br>
<br> - Serology with SARS-CoV-2 negative IgG antibodies; This inclusion criteria does not
<br> apply to participants enrolled from version 4.0 of the protocol onwards.
<br>
<br> - Willing to allow investigators to discuss the participant's clinical history with
<br> their GP/personal physician and access medical records relevant to the study
<br> procedures
<br>
<br> - Only for women of childbearing age willing to practice continuous effective birth
<br> control (see below) during the study, and a negative pregnancy test on the screening
<br> and vaccination day(s);
<br>
<br> - Consent to abstain from blood donation during the course of the study;
<br>
<br> - Provide informed consent in writing
<br>
<br> Exclusion Criteria:
<br>
<br> - Participation in trials of prophylactic drugs for COVID-19 during the course of the
<br> study; Note: Participation in COVID-19 treatment trials is permitted in case of
<br> hospitalization due to COVID-19, after confirmation of positive PCR. The study team
<br> should be informed as soon as possible. Participants with COVID-19 not hospitalized
<br> with positive PCR results for COVID-19 may be medicated according to standard clinical
<br> practice.
<br>
<br> - Participation in SARS-CoV-2 serological research where participants are informed of
<br> their serological status during the course of the study;
<br>
<br> - Planned receipt of any vaccine (authorized or investigational), within 30 days before
<br> and after vaccination;
<br>
<br> - Prior receipt of an investigational vaccine or authorized with the possibility of
<br> impacting the interpretation of the study data (for example, vaccines vectorized by
<br> Adenovirus, any vaccines against coronavirus);
<br>
<br> - Administration of immunoglobulins and/or any blood products in the three months prior
<br> to the planned administration of the candidate vaccine;
<br>
<br> - Any confirmed or suspected immunosuppressive or immunodeficiency state; asplenia;
<br> severe recurrent infections and chronic use (more than 14 days) of immunosuppressive
<br> medication in the last 6 months, except for topical steroids or short-term oral
<br> steroids (cycle lasting =14 days);
<br>
<br> - History of allergic disease or reactions possibly exacerbated by any component of
<br> ChAdOx1 nCoV-19 or MenACWY or paracetamol;
<br>
<br> - Any history of angioedema;
<br>
<br> - Any history of anaphylaxis;
<br>
<br> - Pregnancy, lactation or willingness/intention to become pregnant during the study;
<br>
<br> - Current diagnosis or treatment for cancer (except basal cell carcinoma of the skin and
<br> cervical carcinoma in situ);
<br>
<br> - History of severe psychiatric illness that possibly affects your participation in the
<br> study;
<br>
<br> - Hemorrhagic disorder (for example, factor deficiency, coagulopathy or platelet
<br> disorder), or a previous history of significant bleeding or bruising after IM
<br> injections or venipuncture;
<br>
<br> - Current suspected or known dependence on alcohol or drugs;
<br>
<br> - Severe and/or uncontrolled cardiovascular diseases, respiratory diseases,
<br> gastrointestinal diseases, liver disease, kidney disease, endocrine disorder, and
<br> neurological disease (mild/moderate well-controlled comorbidities are allowed);
<br>
<br> - History of COVID-19 confirmed by laboratory;
<br>
<br> - Seropositive for antibodies to SARS-CoV-2 before recruitment; This exclusion criteria
<br> does not apply to participants enrolled from version 4.0 of the protocol onwards
<br>
<br> - Continued use of anticoagulants, such as coumarins and related anticoagulants (for
<br> example, warfarin) or new oral anticoagulants (for example, apixaban, rivaroxaban,
<br> dabigatran and edoxaban);
<br>
<br> - Any other significant illness, disorder or finding that may significantly increase the
<br> risk for the participant, affect his/her ability to participate in the study or impair
<br> the interpretation of the study data.
<br>
<br> Re-vaccination exclusion criteria (two-dose groups only)
<br>
<br> - Anaphylactic reaction following administration of vaccine
<br>
<br> - Pregnancy
<br> | | Coronavirus | Biological: ChAdOx1 nCoV-19 single dose + paracetamol;Biological: MenACWY single dose + paracetamol;Biological: ChAdOx1 nCoV-19 two dose + paracetamol;Biological: MenACWY prime & saline placebo boost + paracetamol | Evaluate the efficacy of ChAdOx1 nCoV-19 vaccine against COVID-19 disease confirmed with PCR | | | | Yes | False | | |
| → | NCT04536285 | 12 December 2020 | Hospitalized Children and Adolescent Patients With Type 1 Diabetes During the COVID-19 Pandemic in Egypt | Clinical Characteristics and Outcome of Hospitalized Children and Adolescent Patients With Type 1 Diabetes During the COVID-19 Pandemic: Data From a Single Center Surveillance Study in Egypt | | Ain Shams University | 27/08/2020 | 20200827 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04536285 | Not recruiting | No | 1 Year | 18 Years | All | May 1, 2020 | 36 | Observational | | | Egypt | | Yasmine Elhenawy | | | | Ain Shams University |
<br> Inclusion Criteria:
<br>
<br> - All patients with type 1 diabetes admitted to Pediatrics Hospital, Ain Shams
<br> University in the period between May to July 2020.
<br>
<br> - Age: less than 18 years old.
<br>
<br> Exclusion Criteria:
<br>
<br> • Children with other forms of diabetes, including: type 2, monogenic forms and secondary
<br> diabetes
<br> | | Type 1 Diabetes;Covid19 | | Prognosis of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.;Laboratory characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.;Clinical characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.→Clinical characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.;Laboratory characteristic of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19.;Prognosis of pediatric and adolescent patients with type 1 diabetes hospitalized with COVID -19. | | | | Yes | False | | |
| NCT04536363 | 12 December 2020 | Cri Analog PG1 Effectiveness and Safety in Covid-19 | Effectiveness and Safety of the Administration of Intravenous Prostaglandin E1 Analog in the Reduction of Mortality and Complications of Patients With COVID-19 | PGE1-COVID19 | Alonso Vera Torres | 29/08/2020 | 20200829 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04536363 | Not recruiting | No | 18 Years | N/A | All | October 1, 2020 | 284 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | | | Alonso Vera Torres, MD | | Alonso.Vera@fsfb.org.co | +573107632766 | |
<br> Inclusion Criteria:
<br>
<br> - Patient older than 18 years of age
<br>
<br> - COVID19 diagnosis:
<br>
<br> - RT PCR for COVID-19 positive in respiratory tract sample (nasopharyngeal swab,
<br> sputum, bronchoalveolar lavage)
<br>
<br> - At least 2 of the following symptoms: cough, odynophagia, dyspnea, asthenia,
<br> adynamia, gastrointestinal symptoms.
<br>
<br> - Findings compatible with viral pneumonia on chest tomography or chest
<br> radiography.
<br>
<br> - Risk of respiratory deterioration given by at least 1 of the following:
<br>
<br> - Hypoxemia: PaO2 <60 mmHg, SaO2 <90% or supplemental O2 requirement to maintain SaO2>
<br> 90%
<br>
<br> - Call Score = 9 points
<br>
<br> - FR> 30 / min
<br>
<br> - PaO2 / FiO2 less than 200
<br>
<br> - Intubated patients without deterioration of other organs (without acute kidney injury,
<br> without elevated transaminases).
<br>
<br> - Progression of radiological findings of pneumonia.
<br>
<br> - Patients with moderate or severe oxygenation disorder, with diaphragm of 200-100 and
<br> <100 respectively, who require supplemental oxygen at high flow (non-rebreathing mask
<br> or high flow cannula).
<br>
<br> - Complete record of medical history, allergies, and medical conditions that preclude
<br> the use of prostaglandin E1 analogs have been ruled out.
<br>
<br> - Voluntary participation in the study, demonstrating fullness through informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Allergy or sensitivity to PEG1 analog or components
<br>
<br> 2. Arterial hypotension defined as blood pressure less than 90/60 mm of mercury or mean
<br> arterial pressure less than 65mm of mercury or BP requirement <80/50 mmHg or TAM 60
<br> mmHg with norepinephrine requirement greater than 0.1 mcg / kg / min
<br>
<br> 3. Severe hypertension defined as systolic blood pressure greater than or equal to 180 mm
<br> of mercury and / or diastolic blood pressure greater than or equal to 110 mm of
<br> mercury
<br>
<br> 4. Bradycardia defined as heart rate less than 60 beats per minute
<br>
<br> 5. Previous events of priapism or penile anatomical changes
<br>
<br> 6. Sickle cell disease, multiple myeloma, leukemia, polycythemia vera, thrombocythemia
<br> predisposing to priapism
<br>
<br> 7. Hemorrhagic diathesis
<br>
<br> 8. Active peptic ulcer, trauma, or recent brain hemorrhage.
<br>
<br> 9. Abnormal pulmonary venous return with obstruction
<br>
<br> 10. Pregnancy: A pregnancy test will be performed upon admission of the patient to the
<br> study (if applicable).
<br>
<br> 11. Heart failure with NYHA functional class> 1
<br>
<br> 12. Hemodynamically relevant arrhythmia: That generates hypotension, chest pain,
<br> dysfunction, sensory disturbance or other signs of low output
<br>
<br> 13. Mitral and / or aortic stenosis and / or insufficiency of either
<br>
<br> 14. Unstable angina
<br>
<br> 15. Acute Myocardial Infarction in the last 6 months
<br>
<br> 16. Ischemic or hemorrhagic cerebrovascular event in the last 6 months
<br>
<br> 17. Child B or C or decompensated liver cirrhosis
<br>
<br> 18. Chronic kidney disease in renal replacement therapy
<br>
<br> 19. Serious medical condition or laboratory findings that, in the investigator's judgment,
<br> may compromise patient safety during participation in the study
<br> | | Covid19 | Drug: Analogs, Prostaglandin E1;Drug: Standard therapeutic protocol | Mortality | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04537585 | 12 December 2020 | COVID-19: Collecting Measurements of Renin-angiotensin-system Markers, Such as Angiotensin-2 and Angiotensin 1-7 | A Multi-center, Investigator-blinded, Randomized Clinical Trial, 18-months, Parallel-group to Compare the Efficacy of Tomeka® Foods Versus Vernonia Amygdalina in the Prevention and Maintenance of Remission of COVID-19 in DRC | Tomeka | Guyguy K Tshima, MD | 29/08/2020 | 20200829 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04537585 | Not recruiting | No | 15 Years | 65 Years | All | November 2020 | 2000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | Congo, The Democratic Republic of the | ; | Guyguy K. Tshima, MD;Guyguy K. Tshima, MD | | ;guyguytshimakabundi@gmail.com | ;0015143819264 | University of Kinshasa; |
<br> Inclusion Criteria:
<br>
<br> Patients eligible for the trial must comply with all of the following at randomization:
<br>
<br> 1. Age =15 years
<br>
<br> 2. Current admission under the care of the heart-failure service at the site
<br>
<br> 3. Fulfill Inclusion criteria and accept
<br>
<br> 4. COVID-19 patients confirmed
<br>
<br> 5. be regular on appointments
<br>
<br> 6. No voluntary patient (see: having signed the informed consent) The criteria for
<br> choosing subjects: subjects who are themselves exposed to the consumption of Vernonia
<br> amygdalina (Kananga, Tshikapa or in Kasaï region). This group can be part of the
<br> cohort. tare: to compare with a no exposure group which is external to the cohort.
<br>
<br> Here is the follow-up procedure for the two groups throughout the study:
<br>
<br> - follow-up modality: visits, letters, work-study
<br>
<br> - frequency of contacts: monthly
<br>
<br> - total duration of follow-up: 9 months Patients enrolled in the individual data
<br> investigational study are potential candidates for TOMEKA intervention. As the TOMEKA
<br> protocol does not involve any investigational agents or techniques, patients would be
<br> eligible for dual randomization if they are themselves on stable doses of Vernonia
<br> amygdalina (the investigational herbs drugs may equivalent to Remdesivir).
<br>
<br> Exclusion Criteria:
<br>
<br> 1. COVID-19 suspected clinically
<br>
<br> 2. Children
<br>
<br> 3. Refuse to participate
<br>
<br> 4. Recover when possible the cause of a study exit:
<br>
<br> - refusal of follow-up
<br>
<br> - move
<br>
<br> - death If the patient is no longer followed in the study without any cause being
<br> identified, then he is lost to follow-up.
<br> | | Covid19 | Combination Product: Tomeka®;Drug: "Vernonia amygdalina" | Number of participants with treatment-TOMEKA® usage | | | | Yes | False | | |
| → | NCT04537858 | 12 December 2020 | Virtual Reality Therapy Influence on Heart Rate Variability of Inpatients With COVID-19 | Analysis of the Influence of Rehabilitation With Virtual Reality on the Heart Rate Variability of Individuals Under Treatment of COVID-19 in a Hospital Unit. | | University of Sao Paulo | 29/08/2020 | 20200829 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04537858 | Not recruiting | No | 20 Years | 80 Years | All | June 18, 2020 | 50 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Brazil | | Talita D da Silva, Ph.D. | | | | Universidade Federal de São Paulo |
<br> Inclusion Criteria:
<br>
<br> - Inpatients with confirmed diagnosis of COVID-19.
<br>
<br> Exclusion Criteria:
<br>
<br> - Cardiac arrhythmias and atrioventricular block,
<br>
<br> - Congenital anomalies, such as congenital heart disease,
<br>
<br> - Pulmonary malformations,
<br>
<br> - Drugs that interfere with SNA, such as anti-arrhythmic drugs.
<br> | | COVID-19;Inpatient | Device: Virtual reality therapy first;Device: Conventional therapy first | Heart Rate Variability;Motor Skills→Motor Skills;Heart Rate Variability | | | | Yes | False | | |
| NCT04538469 | 12 December 2020 | Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff | Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff | VINCI | University of Glasgow | 01/09/2020 | 20200901 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04538469 | Not recruiting | No | 18 Years | 100 Years | All | September 2020 | 1000 | Observational | | | | ; ; | Ben Shelley;Leah Hughes;Leah Hughes | | ;;leah.hughes@gjnh.scot.nhs.uk | ;;0141 951 5305 | National Waiting Times Centre Board;National Waiting Times Centre Board; |
<br> Arm 1
<br>
<br> Inclusion Criteria:
<br>
<br> - Length of stay within critical care > 4 days
<br>
<br> - Age > 18 years
<br>
<br> - Patients who have been admitted:
<br>
<br> - Following cardiac or thoracic surgery or,
<br>
<br> - For treatment of advanced heart failure
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnancy
<br>
<br> - Diagnosed learning disability
<br>
<br> - Pre-admission evidence of cognitive impairment
<br>
<br> - Patients admitted to the ICU following ear nose and throat (ENT) procedures
<br>
<br> - Patients admitted to the ICU following orthopaedics procedure
<br>
<br> - Patients admitted to the ICU following general surgical procedures
<br>
<br> - Patients admitted following out of hospital cardiac arrest
<br>
<br> - Patients admitted for COVID-19 pneumonia
<br>
<br> Arm 2
<br>
<br> Inclusion Criteria:
<br>
<br> For Patients:
<br>
<br> - Length of stay within critical care > 4 days
<br>
<br> - Age > 18 years
<br>
<br> - Reason for admission
<br>
<br> - Post-operative patients following cardiac or thoracic surgery or,
<br>
<br> - Following admission for advanced heart failure therapies
<br>
<br> - Provision of informed consent
<br>
<br> For relatives:
<br>
<br> - Age > 18 years
<br>
<br> - Relative of a patient that has been in critical care > 4 days
<br>
<br> - Relative of a patient who has been admitted:
<br>
<br> - Following cardiac or thoracic surgery or,
<br>
<br> - Treatment of advanced heart failure
<br>
<br> - Relative of a patient admitted for > 4days
<br>
<br> For Staff:
<br>
<br> - Age > 18
<br>
<br> - Clinical responsibility within the critical care department
<br>
<br> Exclusion:
<br>
<br> For patients:
<br>
<br> - Prisoners
<br>
<br> - Age < 18yrs
<br>
<br> - No family or social support
<br>
<br> - Non-English speaker
<br>
<br> - Pre-admission evidence of cognitive impairment
<br>
<br> - Pre-admission diagnosis of learning disability
<br>
<br> - Imminent death
<br>
<br> - Brain injury
<br>
<br> - Lacks capacity (using Montreal Cognitive Assessment tool (MoCA))
<br>
<br> - Patients admitted after out of hospital cardiac arrest
<br>
<br> - Patients admitted to the ICU following ENT procedures
<br>
<br> - Patients admitted to the ICU following orthopaedics procedure
<br>
<br> - Patients admitted to the ICU following general surgical procedures
<br>
<br> - Patients admitted with COVID-19 pneumonia
<br>
<br> For relatives:
<br>
<br> - Prisoner
<br>
<br> - Age < 18yrs
<br>
<br> - Non-English speaker
<br>
<br> - Relative of a patient who is close to death
<br>
<br> - Relative of a patient admitted after out of hospital cardiac arrest
<br>
<br> - Relative of a patient admitted for ENT procedure
<br>
<br> - Relative of a patient admitted for orthopaedic procedure
<br>
<br> - Relative of a patient admitted following general surgical procedure
<br>
<br> For Staff:
<br>
<br> • Age < 18yrs
<br> | | Cardiovascular Diseases;Delirium;Critical Illness;Intensive Care Unit Delirium;Thoracic Diseases;Respiratory Failure;Cardiac Disease;Cardiac Failure | Other: COVID visitation restrictions | Duration of delirium | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04550312 | 12 December 2020 | The Impact of Lifestyle Changes on Non-COVID Deaths | The Impact of Lifestyle Alteration by Strict Prevention Measures on Non-COVID Deaths in the Region With Low COVID-19 Transmission Rate | | The First Affiliated Hospital with Nanjing Medical University | 13/09/2020 | 20200913 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04550312 | Recruiting | No | N/A | N/A | All | September 2020 | 80000 | Observational | | | China | ; ; | minglong chen, PHD;ming chu, PHD;Ming Chu, PHD | | ;chuming@njmu.edu.cn; | ;86-2568136965; | Xuzhou Medical University affiliated hospital; |
<br> Inclusion Criteria:
<br>
<br> - All cases of death reported to the Xuzhou CDC during the study period
<br>
<br> Exclusion Criteria:
<br>
<br> - no
<br> | | Lifestyle Alteration;Non-COVID Deaths | | Numeric values of all-cause death and the death rates of non-COVID diseases | | | | Yes | False | | |
| → | NCT04551274 | 12 December 2020 | Music Therapy in Frontline Healthcare Workers | Investigating the Use of Virtual Music Therapy in Frontline Healthcare Workers During COVID-19 | | Simon Fraser University | 01/09/2020 | 20200901 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04551274 | Not recruiting | No | 19 Years | N/A | All | October 1, 2020 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor). | N/A | Canada | ; ; | Glen Chapman, PhD;Ryan CN D'Arcy, PhD;Shaun D Fickling, PhD | | ;rdarcy@sfu.ca;sficklin@sfu.ca | ;7789199215; | Simon Fraser University; |
<br> Inclusion Criteria:
<br>
<br> - All participants will be required to be frontline healthcare workers, (i.e.
<br> paramedics, EMTs, nurses, doctors). Participants will be adults aged 19 years and
<br> above, who are English speakers, with normal or corrected vision and hearing
<br> abilities. Participants will be required to have independent capacity to consent, as
<br> per Article 3.3 of the TCPS2. Due to the virtual nature of the study, participants
<br> will need to have access to a computer/laptop with a webcam to be able to interact
<br> with the music therapist and the study team.
<br>
<br> Exclusion Criteria:
<br>
<br> - Participants who have experienced a traumatic brain injury in the last 12 months, or
<br> who have previously been diagnosed with any other neurological, neuropsychological, or
<br> psychiatric diseases/disorders/conditions will not be enrolled in the study.
<br> | | Mood;Emotional Stress | Behavioral: Music Therapy | Change in Positive Affect score - NIH Emotion Toolbox;Change in Anger score - NIH Emotion Toolbox;Change in Fear score - NIH Emotion Toolbox;Change in Meaning & Purpose score - NIH Emotion Toolbox;Change in Sadness score - NIH Emotion Toolbox;Change in Emotional Support score - NIH Emotion Toolbox;Change in Loneliness score - NIH Emotion Toolbox;Change in General Life Satisfaction score - NIH Emotion Toolbox;Change in Perceived Stress score - NIH Emotion Toolbox→Change in Loneliness score - NIH Emotion Toolbox;Change in Emotional Support score - NIH Emotion Toolbox;Change in Sadness score - NIH Emotion Toolbox;Change in Meaning & Purpose score - NIH Emotion Toolbox;Change in Fear score - NIH Emotion Toolbox;Change in Anger score - NIH Emotion Toolbox;Change in Positive Affect score - NIH Emotion Toolbox;Change in General Life Satisfaction score - NIH Emotion Toolbox;Change in Perceived Stress score - NIH Emotion Toolbox | | | | Yes | False | | |
| → | NCT04551755 | 12 December 2020 | Safety and Efficacy of Ivermectin and Doxycycline in Treatment of Covid-19 | The Safety and Efficacy Outcome of Ivermectin Plus Doxycycline in Treatment of RT-PCR Positive Adult Mild Covid-19 Cases: a Randomized Double Blind Placebo Controlled Trial | | Bangladesh Medical Research Council (BMRC) | 03/09/2020 | 20200903 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04551755 | Not recruiting | No | 18 Years | N/A | All | September 2020 | 188 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2 | | ; | Mohammad Tarek Alam, MD;Mohammad Tarek Alam, MD | | ;mtarekalam16@gmail.com | ;01819185449 | Bangladesh Medical College Hospital; |
<br> Inclusion Criteria:
<br>
<br> - Subjects within age group 18 years to onward
<br>
<br> - With either sex, male or female
<br>
<br> - Confirmed mild cases of Covid-19 by RT-PCR test
<br>
<br> - patients who are classified as mild cases with typical symptoms
<br>
<br> - patients who are not already treated with any other antiviral drugs
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who are asymptomatic,moderate, severe and critically ill (resting respiratory
<br> rate more than 30, O2 saturation below 93%).
<br>
<br> - Patients with co-morbidities (diabetes, hypertension, chronic liver and kidney
<br> diseases obesity, pre-existing ischemic heart disease, COPD,other severe disease)
<br>
<br> - Patients with pregnancy and on lactation
<br>
<br> - Patients with previous allergic reaction to Ivermectin or Doxycycline
<br> | | Covid19 | Drug: Ivermectin and Doxycycline;Other: Placebo | Negative RT-PCR test on day 5 of treatment;Time to outcome measure of fever (<100.40F)and cough→Time to outcome measure of fever (<100.40F)and cough;Negative RT-PCR test on day 5 of treatment | | | | Yes | False | | |
| NCT04551781 | 12 December 2020 | Short Term Low Dose Corticosteroids for Management of Post covid19 Pulmonary Fibrosis | Short Term Low Dose Corticosteroids for Management of Post Covid-19 Pulmonary Fibrosis | | South Valley University | 13/09/2020 | 20200913 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04551781 | Not recruiting | No | 18 Years | N/A | All | April 1, 2020 | 450 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | N/A | Egypt | | alaa DR Rashad, MD | | | | south-Vally Universty |
<br> Inclusion Criteria:
<br>
<br> - COVID-19 diagnosis with a positive nasopharyngeal swab, they were discharged from
<br> quarantine hospitals after 2 Polymerase chain reaction (PCR) swab negative for
<br> COVID-19, and have persistent radiological changes in follow-up chest computed
<br> tomography (CT) chest
<br>
<br> Exclusion Criteria:
<br>
<br> - patients with normal CT chest at discharge, patients on chemotherapy, patients
<br> <18years old, patients with known interstitial lung disease, and patients with
<br> rheumatoid arthritis or systemic lupus erythematosus
<br> | | Covid19 | Drug: 20 Mg Prednisone for 14 days;Drug: control | improved | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04558463 | 12 December 2020 | The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19 | The Effectivity and Safety of Favipiravir Compared to Oseltamivir as Adjuvant Therapy for COVID-19: An Open Label Trial | | Indonesia University | 03/09/2020 | 20200903 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04558463 | Recruiting | No | 18 Years | 75 Years | All | April 16, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | Indonesia | ; ; | Dante S Harbuwono, MD, PhD;Dante S Harbuwono, MD, PhD;Dante S Harbuwono, MD, PhD | | ;dante.saksono@ui.ac.id;dante.saksono@ui.ac.id | ;+62213907703;+62213907703 | Head of Division Endocrinology, Department of Internal Medicine, FMUI; |
<br> Inclusion Criteria:
<br>
<br> 1. adult patients aged 18-75 years old
<br>
<br> 2. Patients with COVID-19 showing symptoms and confirmed with positive RT PCR test AND OR
<br> COVID-19 IgM/IgG rapid test
<br>
<br> 3. No history of favipiravir or oseltamivir allergy
<br>
<br> 4. Consented to participate in the trial.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnant women
<br>
<br> 2. Breastfeeding mother
<br>
<br> 3. Patients with markedly elevated liver enzyme (ALT and/or AST) of more than three times
<br> from baseline level
<br>
<br> 4. Reduced kidney function with estimated glomerular filtration rate (eGFR) <30 mL/min OR
<br> serum creatinine > 2 mg/dL
<br>
<br> 5. Patients with history of heart failure
<br>
<br> 6. Tuberculosis infection that was treated with pyrazinamide
<br>
<br> 7. Asthma that was treated with theophylline
<br>
<br> 8. Type 2 diabetes that was treated with repaglinid
<br> | | Covid19 | Drug: Favipiravir;Drug: Oseltamivir 75mg | Clinical radiologic changes;Percentage of RT-PCR test convertion | | | | Yes | False | | |
| → | NCT04558645 | 12 December 2020 | Evaluation of Physical Activity and Quality of Life of Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic | Evaluation of Physical Activity, Quality of Life and Depression of Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic | | Gazi University | 18/09/2020 | 20200918 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04558645 | Recruiting | No | 18 Years | 65 Years | All | September 18, 2020 | 70 | Observational | | | Turkey | ; ; ; ; | Zeliha ÇELIK, MSc;Meral BOSNAK GÜÇLÜ, Prof;Füsun BALOS TÖRÜNER, Prof;Zeliha ÇELIK, MSc;Zeliha ÇELIK | | ;;;zelihacelik1@hotmail.com;zelihacelik1@hotmail.com | ;;;+903122162647;+903122162647 | Gazi University;Gazi University;Gazi University; |
<br> Inclusion Criteria:
<br>
<br> - Having been diagnosed with Type 1 Diabetes Mellitus
<br>
<br> - Willing to participate in the study
<br>
<br> - Participants whose native language is Turkish
<br>
<br> Exclusion Criteria:
<br>
<br> - Unwilling to participate in the study
<br>
<br> - Having a cognitive disorder
<br>
<br> - Not being literate
<br>
<br> - Individuals who do not have sufficient knowledge and functional levels to fill out the
<br> online form
<br> | | Type 1 Diabetes Mellitus;Covid19 | Other: Online Survey | Physical activity level;General Quality of life→General Quality of life;Physical activity level | | | | Yes | False | | |
| NCT04558996 | 12 December 2020 | Spanish Registry of Pregnant Women With COVID-19 | REGISTRO EPIDEMIOLOGICO DE COVID 19 EN GESTANTES | OBS COVID | Puerta de Hierro University Hospital | 18/09/2020 | 20200918 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04558996 | Recruiting | No | 18 Years | N/A | Female | March 1, 2020 | 3000 | Observational [Patient Registry] | | | Spain | ; ; | Oscar M Martinez Perez, Epidemiologist;Oscar M Martinez Perez, MD;Oscar M Martinez Perez, MD | | ;oscarmartinezgine@gmail.com;oscarmartinezgine@gmail.com | ;600417307;600417307 | HUHPH; |
<br> Inclusion Criteria:
<br>
<br> -
<br>
<br> Patients eligible for follow-up o target population will be any pregnant woman who is
<br> suspected or needs to be ruled out as having a SARS-CoV-2 infection at any time during
<br> pregnancy with positive test results for SARS-CoV-2 by PCR.
<br>
<br> Information regarding each pregnant woman's demographic characteristics, comorbidities and
<br> current obstetric history was extracted from the medical history and the patient interview;
<br> subsequently, age and race were categorized according to the classification used by the
<br> Center for Disease Control and Prevention (CDC) (17).
<br>
<br> For the selection of the control group to be collected in the same database, patients with
<br> a negative COVID-19 delivery diagnosed by PCR screening at delivery, or less than 3 days
<br> before, were considered.
<br>
<br> Exclusion criteria
<br>
<br> Pregnant women under the following conditions will be excluded from the registry:
<br>
<br> - Inability to give informed consent in the absence of a legal representative.
<br>
<br> - If, in the opinion of the researcher, findings in the physical examination, anomalies
<br> in the results of the laboratory tests or other medical, social or psychosocial
<br> factors could have a negative influence.
<br>
<br> - Loss of follow-up data prior to 6 weeks postpartum.
<br> | | Covid19;Pregnancy Complications;Premature Rupture of Membrane;Abruptio Placentae;Prelabor Rupture of Membranes;Stillbirth | | NEONATAL INFECTION;MATERNAL COMPLICATIONS | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04597216 | 12 December 2020 | Exploration of Feasability of Blood and Saliva Proteomic Analysis Through Harvesting by Silica Matrix (NanoDx-CoV-19) | Exploration of Feasability of Blood and Saliva Proteomic Analysis Through Harvesting by Silica Matrix | NanoDxCoV19 | University Hospital, Grenoble | 13/10/2020 | 20201013 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04597216 | Recruiting | No | 18 Years | 99 Years | All | October 15, 2020 | 200 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | France | | olivier EPAULARD | | oepaulard@chu-grenoble.fr | 0033476765291 | |
<br> phase 1:
<br>
<br> Inclusion Criteria for group 1:
<br>
<br> - positive Covid-19 PCR
<br>
<br> - clinical signs evocative of Covid-19
<br>
<br> Exclusion Criteria for group 1:
<br>
<br> - asymptomatic Covid-19 infection
<br>
<br> Inclusion Criteria for group 1:
<br>
<br> - negative Covid-19 PCR
<br>
<br> - acute respiratory infection
<br>
<br> Exclusion Criteria for group 1:
<br>
<br> - none
<br>
<br> Phase 2
<br>
<br> Inclusion Criteria:
<br>
<br> - suspicion of Covid-19
<br>
<br> - sample for Covid-19 PCR planned or performed the same day
<br>
<br> - admission ot emergency room exclusion criteria:
<br>
<br> - past known Covid-19
<br> | | Covid19 | Device: sample of blood and saliva | Feasibility of proteomic profile | | | | Yes | False | | |
| → | NCT04597736 | 12 December 2020 | Relationship Between Biological Profiles and Clinical Evolutions Within the Same Cluster COVID-19 (COVIDCOLLECT) | Biological Collection for the Study of the Relationship Between the Biological Profiles Observed and the Clinical Evolutions Within the Same Cluster of Transmission of the Coronavirus SARS-CoV-2 | COVIDCOLLECT | University Hospital, Clermont-Ferrand | 02/10/2020 | 20201002 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04597736 | Not recruiting | No | N/A | N/A | All | November 2020 | 100 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | France | ; ; | Céclie Henquell;Lise LACLAUTRE;Lise Laclautre | | ;promo_interne_drci@chu-clermontferrand.fr;promo_interne_drci@chu-clermontferrand.fr | ;+33473754963;+33473754963 | University Hospital, Clermont-Ferrand; |
<br> Inclusion Criteria:
<br>
<br> - Child or adult, no age limit
<br>
<br> - Able to give informed consent to participate in research
<br>
<br> - If a minor participant: consent of the legal representatives
<br>
<br> - If confirmed case COVID-19 (symptomatic or asymptomatic): laboratory result confirming
<br> infection with SARS-CoV-2 by RT-PCR or by serology
<br>
<br> - If contact case: people identified as a risk contact according to the criteria of the
<br> "Amélie.fr" health insurance
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects under tutorship, curatorship, deprived of liberty, safeguard of justice
<br>
<br> - Refusal of the child
<br>
<br> - Refusal of participation
<br> | | Covid19;Contact Case | Biological: Biological collection with nasopharyngeal samples, saliva, blood, stool and urine | Biochemical profile by blood dosage of Lactate;Biochemical profile by blood dosage of Lactate;Biochemical profile by blood dosage of Lactate;Biochemical profile by blood dosage of LDH;Biochemical profile by blood dosage of LDH;Biochemical profile by blood dosage of LDH;Biochemical profile by blood dosage of LDH;Biochemical profile by blood dosage of ASAT/ALAT;Biochemical profile by blood dosage of ASAT/ALAT;Biochemical profile by blood dosage of ASAT/ALAT;Biochemical profile by blood dosage of ASAT/ALAT;Biochemical profile by blood dosage of CRP;Biochemical profile by blood dosage of CRP;Biochemical profile by blood dosage of CRP;Biochemical profile by blood dosage of CRP;Immunological profile with blood level for markers of inflammation;Immunological profile with blood level for markers of inflammation;Immunological profile with blood level for markers of inflammation;Immunological profile with blood level for markers of inflammation (cytokine);Immunological profile with blood level for markers of inflammation (cytokine);Immunological profile with blood level for markers of inflammation (cytokine);Virological profile (serology);Virological profile (serology);Virological profile (serology);Virological profile;Virological profile;Virological profile;Biochemical profile by blood dosage of Lactate;Haematological profile by blood dosage of Red blood cells;Haematological profile by blood dosage of Hemoglobin;Haematological profile by blood dosage of Hemoglobin;Haematological profile by blood dosage of Hemoglobin;Haematological profile by blood dosage of Hemoglobin;Haematological profile by blood dosage of Hematocrit;Haematological profile by blood dosage of Hematocrit;Haematological profile by blood dosage of Hematocrit;Haematological profile by blood dosage of Hematocrit;Haematological profile by blood dosage of Mean corpuscular volume;Haematological profile by blood dosage of Mean corpuscular volume;Haematological profile by blood dosage of Mean corpuscular volume;Haematological profile by blood dosage of Mean corpuscular volume;Haematological profile by blood dosage of Mean corpuscular hemoglobin;Haematological profile by blood dosage of Mean corpuscular hemoglobin;Haematological profile by blood dosage of Mean corpuscular hemoglobin;Haematological profile by blood dosage of Mean corpuscular hemoglobin;Haematological profile by blood dosage of average corpuscular concentration of haemoglobin;Haematological profile by blood dosage of average corpuscular concentration of haemoglobin;Haematological profile by blood dosage of average corpuscular concentration of haemoglobin;Haematological profile by blood dosage of average corpuscular concentration of haemoglobin;Haematological profile by blood dosage of polynuclear neutrophil;Haematological profile by blood dosage of polynuclear neutrophil;Haematological profile by blood dosage of polynuclear neutrophil;Haematological profile by blood dosage of polynuclear neutrophil;Haematological profile by blood dosage of polynuclear eosinophils;Haematological profile by blood dosage of polynuclear eosinophils;Haematological profile by blood dosage of polynuclear eosinophils;Haematological profile by blood dosage of polynuclear eosinophils;Haematological profile by blood dosage of polynuclear basophils;Haematological profile by blood dosage of polynuclear basophils;Haematological profile by blood dosage of polynuclear basophils;Biochemical profile by blood dosage of D-Dimer;Biochemical profile by blood dosage of D-Dimer;Biochemical profile by blood dosage of D-Dimer;Biochemical profile by blood dosage of D-Dimer;Biochemical profile by blood dosage of Troponin;Biochemical profile by blood dosage of Troponin;Biochemical profile by blood dosage of Troponin;Biochemical profile by blood dosage of Troponin;Biochemical profile by blood dosage of Ferritin;Biochemical profile by blood dosage of Ferritin;Biochemical profile by blood dosage of Ferritin;Biochemical profile by blood dosage of RAGE;Biochemical profile by blood dosage of RAGE;Biochemical profile by blood dosage of RAGE;Biochemical profile by blood dosage of SUPAR;Biochemical profile by blood dosage of SUPAR;Biochemical profile by blood dosage of SUPAR;Haematological profile by blood dosage of leukocytes;Haematological profile by blood dosage of leukocytes;Haematological profile by blood dosage of leukocytes;Haematological profile by blood dosage of leukocytes;Haematological profile by blood dosage of Red blood cells;Haematological profile by blood dosage of Red blood cells;Haematological profile by blood dosage of Red blood cells;Haematological profile by blood dosage of polynuclear basophils;Haematological profile by blood dosage of lymphocytes;Haematological profile by blood dosage of lymphocytes;Haematological profile by blood dosage of lymphocytes;Haematological profile by blood dosage of lymphocytes;Haematological profile by blood dosage of monocytes;Haematological profile by blood dosage of monocytes;Haematological profile by blood dosage of monocytes;Haematological profile by blood dosage of monocytes;Haematological profile by blood dosage of platelets;Haematological profile by blood dosage of platelets;Haematological profile by blood dosage of platelets;Haematological profile by blood dosage of platelets;Haematological profile by blood dosage of activated partial thromboplastin time;Haematological profile by blood dosage of activated partial thromboplastin time;Haematological profile by blood dosage of activated partial thromboplastin time;Haematological profile by blood dosage of activated partial thromboplastin time;Haematological profile by blood dosage of fibrinogen;Haematological profile by blood dosage of fibrinogen;Haematological profile by blood dosage of fibrinogen;Haematological profile by blood dosage of fibrinogen;Haematological profile by blood dosage of factor V;Haematological profile by blood dosage of factor V;Haematological profile by blood dosage of factor V;Haematological profile by blood dosage of factor V→Biochemical profile by blood dosage of Lactate;Biochemical profile by blood dosage of Lactate;Biochemical profile by blood dosage of Lactate;Biochemical profile by blood dosage of LDH;Biochemical profile by blood dosage of LDH;Biochemical profile by blood dosage of LDH;Biochemical profile by blood dosage of LDH;Biochemical profile by blood dosage of ASAT/ALAT;Biochemical profile by blood dosage of ASAT/ALAT;Biochemical profile by blood dosage of ASAT/ALAT;Biochemical profile by blood dosage of ASAT/ALAT;Biochemical profile by blood dosage of CRP;Biochemical profile by blood dosage of CRP;Biochemical profile by blood dosage of CRP;Biochemical profile by blood dosage of CRP;Immunological profile with blood level for markers of inflammation;Immunological profile with blood level for markers of inflammation;Immunological profile with blood level for markers of inflammation;Immunological profile with blood level for markers of inflammation (cytokine);Immunological profile with blood level for markers of inflammation (cytokine);Immunological profile with blood level for markers of inflammation (cytokine);Virological profile (serology);Virological profile (serology);Virological profile (serology);Virological profile;Virological profile;Virological profile;Biochemical profile by blood dosage of Lactate;Haematological profile by blood dosage of Red blood cells;Haematological profile by blood dosage of Hemoglobin;Haematological profile by blood dosage of Hemoglobin;Haematological profile by blood dosage of Hemoglobin;Haematological profile by blood dosage of Hemoglobin;Haematological profile by blood dosage of Hematocrit;Haematological profile by blood dosage of Hematocrit;Haematological profile by blood dosage of Hematocrit;Haematological profile by blood dosage of Hematocrit;Haematological profile by blood dosage of Mean corpuscular volume;Haematological profile by blood dosage of Mean corpuscular volume;Haematological profile by blood dosage of Mean corpuscular volume;Haematological profile by blood dosage of Mean corpuscular volume;Haematological profile by blood dosage of Mean corpuscular hemoglobin;Haematological profile by blood dosage of Mean corpuscular hemoglobin;Haematological profile by blood dosage of Mean corpuscular hemoglobin;Haematological profile by blood dosage of Mean corpuscular hemoglobin;Haematological profile by blood dosage of average corpuscular concentration of haemoglobin;Haematological profile by blood dosage of average corpuscular concentration of haemoglobin;Haematological profile by blood dosage of average corpuscular concentration of haemoglobin;Haematological profile by blood dosage of average corpuscular concentration of haemoglobin;Haematological profile by blood dosage of polynuclear neutrophil;Haematological profile by blood dosage of polynuclear neutrophil;Haematological profile by blood dosage of polynuclear neutrophil;Haematological profile by blood dosage of polynuclear neutrophil;Haematological profile by blood dosage of polynuclear eosinophils;Biochemical profile by blood dosage of D-Dimer;Biochemical profile by blood dosage of D-Dimer;Biochemical profile by blood dosage of D-Dimer;Biochemical profile by blood dosage of D-Dimer;Biochemical profile by blood dosage of Troponin;Biochemical profile by blood dosage of Troponin;Biochemical profile by blood dosage of Troponin;Biochemical profile by blood dosage of Troponin;Biochemical profile by blood dosage of Ferritin;Biochemical profile by blood dosage of Ferritin;Biochemical profile by blood dosage of Ferritin;Biochemical profile by blood dosage of RAGE;Biochemical profile by blood dosage of RAGE;Biochemical profile by blood dosage of RAGE;Biochemical profile by blood dosage of SUPAR;Biochemical profile by blood dosage of SUPAR;Biochemical profile by blood dosage of SUPAR;Haematological profile by blood dosage of leukocytes;Haematological profile by blood dosage of leukocytes;Haematological profile by blood dosage of leukocytes;Haematological profile by blood dosage of leukocytes;Haematological profile by blood dosage of Red blood cells;Haematological profile by blood dosage of Red blood cells;Haematological profile by blood dosage of Red blood cells;Haematological profile by blood dosage of polynuclear eosinophils;Haematological profile by blood dosage of fibrinogen;Haematological profile by blood dosage of fibrinogen;Haematological profile by blood dosage of factor V;Haematological profile by blood dosage of factor V;Haematological profile by blood dosage of factor V;Haematological profile by blood dosage of factor V;Haematological profile by blood dosage of polynuclear eosinophils;Haematological profile by blood dosage of polynuclear eosinophils;Haematological profile by blood dosage of polynuclear basophils;Haematological profile by blood dosage of polynuclear basophils;Haematological profile by blood dosage of polynuclear basophils;Haematological profile by blood dosage of polynuclear basophils;Haematological profile by blood dosage of lymphocytes;Haematological profile by blood dosage of lymphocytes;Haematological profile by blood dosage of lymphocytes;Haematological profile by blood dosage of lymphocytes;Haematological profile by blood dosage of monocytes;Haematological profile by blood dosage of monocytes;Haematological profile by blood dosage of monocytes;Haematological profile by blood dosage of monocytes;Haematological profile by blood dosage of platelets;Haematological profile by blood dosage of platelets;Haematological profile by blood dosage of platelets;Haematological profile by blood dosage of platelets;Haematological profile by blood dosage of activated partial thromboplastin time;Haematological profile by blood dosage of activated partial thromboplastin time;Haematological profile by blood dosage of activated partial thromboplastin time;Haematological profile by blood dosage of activated partial thromboplastin time;Haematological profile by blood dosage of fibrinogen;Haematological profile by blood dosage of fibrinogen | | | | Yes | False | | |
| NCT04597775 | 12 December 2020 | Chemoprevention Clinical Trial of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis | A Prospective, Randomized, Adaptive Phase II/III Clinical Trial, Controlled, Open-label, 3-arms, Parallel, Multi-centred, Chemoprevention of COVID-19: Hydroxychloroquine Post Exposure Prophylaxis For COVID-19 | APCC-19 | Regional Center for Disease Control and Prevention, Jordan | 18/10/2020 | 20201018 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04597775 | Not recruiting | No | 18 Years | 65 Years | All | October 27, 2020 | 93 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 2/Phase 3 | | ; ; | Munir Abu-Helalah, PHD;Wissem Hachfi, MD;Munir A Abu-Helalah, PhD | | ;;mabuhelalah@yahoo.co.uk | ;;00962795912413 | Regional Center for Disease Control;Farhat Hached Hospital, Tunisia; |
<br> Inclusion Criteria:
<br>
<br> - Primary contacts, described below, aged 18 to 65 years and having provide Written
<br> informed consent by the patient, by the patient's legal /authorized representative as
<br> applicable.
<br>
<br> According to below criteria, as soon as a new subject in identified, he/she will be
<br> consented for reaching his contacts according to below criteria. The research team within
<br> 48 hours of index case identification will call his/her contacts who fulfill below criteria
<br> for participation in the trial. All potential participants will be tested using RT-PCR and
<br> IgM and IgG antibodies to rule out current or previous disease status.
<br>
<br> Contact is a person free from COVID-19 who experienced any one of the following exposures
<br> during the 2 days before and the 14 days after the onset of symptoms of a probable or
<br> confirmed case:
<br>
<br> - A person living in the same household as a COVID-19 case
<br>
<br> - A person having had direct physical contact with a COVID-19 case (e.g. shaking hands)
<br>
<br> - A person having unprotected direct contact with infectious secretions of a COVID-19
<br> case (e.g. being coughed on, touching used paper tissues with a bare hand)
<br>
<br> - A person having had face-to-face contact with a COVID-19 case within 2 meters [2] and
<br> > 15 minutes
<br>
<br> - A person who was in a closed environment (e.g. classroom, meeting room, hospital
<br> waiting room, etc.) with a COVID-19 case for 15 minutes or more and at a distance of
<br> less than 2 meters
<br>
<br> - A healthcare worker (HCW) or other person providing direct care for a COVID-19 case,
<br> or laboratory workers handling specimens from a COVID-19 case without recommended
<br> personal protective equipment or with a possible breach of personal protective
<br> equipment use policies
<br>
<br> - A contact in an aircraft sitting within two seats (in any direction) of the COVID-19
<br> case, travel companions or persons providing care, and crew members serving in the
<br> section of the aircraft where the index case was seated (if severity of symptoms or
<br> movement of the case indicate more extensive exposure, passengers seated in the entire
<br> section or all passengers on the aircraft may be considered close contacts)
<br>
<br> Exclusion Criteria:
<br>
<br> - Women who are pregnant (at the time of screening) or breastfeeding
<br>
<br> - known hypersensitivity or allergy to hydroxychloroquine or other aminoquinoline
<br> compounds
<br>
<br> - History of severe skin reactions such as Stevens-Johnson syndrome and toxic epidermal
<br> necrolysis
<br>
<br> - History of pre-existing retinopathy or maculopathy,
<br>
<br> - concomitant use of tamoxifen
<br>
<br> - History of congenital or acquired long QT-interval, current use of drugs that prolong
<br> the QT interval,
<br>
<br> - family history of long QT arrythmia, cardiac disease such as heart failure, myocardial
<br> infarction
<br>
<br> - concurrent use of anti-arrhythmic drugs, or family history of sudden cardiac death, or
<br> sudden cardiac death, bradycardia < 50 beats/min, uncorrected hypokalemia or
<br> hypomagnesemia
<br>
<br> - severe renal disease or patients receiving dialysis
<br>
<br> - Patients less than 35 kg bodyweight
<br>
<br> - Currently taking Hydroxychloroquine
<br>
<br> - Suspected or confirmed current COVID-19, defined as: (1) temperature > 38 Celsius; (2)
<br> cough; (3) shortness of breath; (4) sore throat; or, if available (not required), (5)
<br> positive confirmatory testing for COVID-19
<br>
<br> - Inability to take medications orally
<br>
<br> - Inability to provide written consent
<br>
<br> - With significantly abnormal liver function
<br>
<br> - Participants with psoriasis, myasthenia, hematopoietic and retinal diseases,
<br> CNS-related hearing loss;
<br>
<br> - RT-PCR positive for SARS-CoV-2, IgM and IgG antibodies for SARS-CoV-2
<br>
<br> - Currently using another treatment regimen or medication that is being investigated for
<br> efficacy in the management of COVID-19.
<br> | | SARS-CoV Infection | Drug: hydroxychloroquine | Incidence rate of COVID-19 on day 14 according to positive results of RT-PCR rate at day 14;Safety and adverse events (AEs) incidence rate at day 14 | | | | Yes | False | | |
| → | NCT04598256 | 12 December 2020 | Endoscopic Procedures of Children in the Normalization Process of Covid-19 Pandemic | Evaluation of Children Who Were Underwent Endoscopic Procedures in the Normalization Process of Covid-19 Pandemic | | Tepecik Training and Research Hospital | 21/10/2020 | 20201021 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04598256 | Not recruiting | No | 1 Year | 18 Years | All | June 1, 2020 | 77 | Observational [Patient Registry] | | | Turkey | ; ; ; ; | BETÜL AKSOY, MD;YELIZ ÇAGAN APPAK, MD;DILEK YILMAZ ÇIFTDOGAN, PROFESSOR;MASALLAH BARAN, PROFESSOR;SENAY ONBASI KARABAG, MD | | ;;;; | ;;;; | Yes;Yes;Yes;Yes;Yes |
<br> Inclusion Criteria:
<br>
<br> - Children between the ages of 1-18 who will undergo endoscopic procedures
<br>
<br> - Patients who can be questioned about COVID-19 infection before and on the 7th and 14th
<br> days after the procedure
<br>
<br> - Patients who volunteered to study
<br>
<br> Exclusion Criteria:
<br>
<br> - Under 1 year and over 18 years of age
<br>
<br> - Patients who could not be questioned about COVID-19 infection before the procedure and
<br> on the 7th and 14th days after the procedure
<br>
<br> - Patients who not volunteered to study
<br> | | Covid19 | Procedure: Endoscopic procedure | The number of participiants who was infected with Covid-19. normalization process of Covid-19 pandemic;The time of seen covid 19 infection after the endoscopic procedures in participiants.;The characteristics of patients with Covid-19 infection.→The characteristics of patients with Covid-19 infection.;The time of seen covid 19 infection after the endoscopic procedures in participiants.;The number of participiants who was infected with Covid-19. normalization process of Covid-19 pandemic | | | | Yes | False | | |
| NCT04598347 | 12 December 2020 | Evaluation of the Possible Vertical Transmission of SARS-CoV-2 Through Study of Amniotic Fluid and Chorionic Villi of Affected Pregnant Women for the COVID-19 | Valuation of the Possible Vertical Transmission of SARS-CoV-2 Through Study of Amniotic Fluid and Chorionic Villi of Affected Pregnant Women for the COVID-19 | | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | 21/10/2020 | 20201021 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04598347 | Recruiting | No | 18 Years | 90 Years | Female | August 8, 2020 | 225 | Observational [Patient Registry] | | | Spain | ; | Obdulia Alejos Abad, PhD, MD;Obdulia Alejos, MD | | oalejos@santpau.cat;oalejos@santpau.cat | +34935537041; | |
<br> Inclusion Criteria:
<br>
<br> - Pregnant women diagnosed with SARS-CoV-2 (by PCR in aspiratenasopharyngeal or
<br> serologies)
<br>
<br> - Patients indicated for an invasive technique(chorionic biopsy or amniocentesis
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who do not meet the inclusion criteria
<br> | | Covid19;Pregnancy Related | | Perinatal SARS-CoV-2 infection | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04602637 | 12 December 2020 | Training Load Management in Three Professional Tennis Players During COVID-19 Lockdown: a Case Series Study | Training Load Management in Three Professional Tennis Players During COVID-19 Lockdown: a Case Series Study | | Kine Kinesiologia Deportiva y Funcional | 22/10/2020 | 20201022 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04602637 | Not recruiting | No | N/A | N/A | Male | December 15, 2019 | 3 | Observational | | | Argentina | | Diego Mendez, PT | | | | Kine Kinesiologia Deportiva y Funcional |
<br> Inclusion Criteria:
<br>
<br> - tennis players training in argentina
<br>
<br> Exclusion Criteria:
<br>
<br> -
<br> | | Monitor Training Load | Other: Training load | Training load | | | | No | False | | |
| → | NCT04602832 | 12 December 2020 | Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19 | A Randomized Controlled Trial of an Online Well-Being Intervention (The ENHANCE Program) for Improving Individuals Health and Well-Being During the COVID-19 Pandemic | EN-COVID-19 | University of British Columbia | 23/10/2020 | 20201023 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04602832 | Recruiting | No | 19 Years | N/A | All | October 14, 2020 | 350 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label). | N/A | Canada | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Individuals who are fluent in English and are 19 years or older.
<br>
<br> Exclusion Criteria:
<br>
<br> - N/A
<br> | | Well-Being | Other: Enduring Happiness and Continued Self-Enhancement (ENHANCE) for COVID-19 | Health Anxiety Inventory Short-Form (HAI-SF);Positive and Negative Affect Scale (PANAS);Perceived Stress Scale (PSS);Patient Health Questionnaire (PHQ-9);Generalized Anxiety Disorder - 7 (GAD-7);Satisfaction With Life Scale (SWLS);Beck Depression Inventory - II (BDI-II)→Beck Depression Inventory - II (BDI-II);Satisfaction With Life Scale (SWLS);Generalized Anxiety Disorder - 7 (GAD-7);Patient Health Questionnaire (PHQ-9);Perceived Stress Scale (PSS);Positive and Negative Affect Scale (PANAS);Health Anxiety Inventory Short-Form (HAI-SF) | | | | Yes | False | | |
| NCT04603664 | 12 December 2020 | Role of NGAL and Cystatin C in Prediction of Acute Kidney Injury Covid-19 Infection | Role of Neutrophil Gelatinase-Associated Lipocalin (NGAL) and Cystatin C in Prediction of Acute Kidney Injury in Patients With Covid-19 Infection | | Ain Shams University | 17/10/2020 | 20201017 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04603664 | Recruiting | No | 18 Years | 65 Years | All | October 30, 2020 | 88 | Observational | | | Egypt | ; | sanaa wasfy;sanaa wasfy, lecturer | | ;sanaawasfy@gmail.com | ;01061262757 | lecturer; |
<br> Inclusion Criteria:
<br>
<br> - person with the one of the following symptoms: fever and respiratory symptoms with
<br> radiological findings of pneumonia compatible with COVID-19
<br>
<br> 1. Respiratory distress (= 30 breaths/ min);
<br>
<br> 2. Oxygen saturation = 93% at rest;
<br>
<br> 3. Arterial partial pressure of oxygen (PaO2)/ fraction of inspired oxygen (FIO2) =
<br> 300.
<br>
<br> 4. Cases with chest imaging that shows obvious lesion progression within 24-48 hours
<br> > 50%.
<br>
<br> 5. Respiratory failure and requiring mechanical ventilation;
<br>
<br> 6. Shock;
<br>
<br> 7. other organ failure that requires ICU care.
<br>
<br> Exclusion Criteria:
<br>
<br> - patients classified as mild corona virsus disease, patients with end-stage renal
<br> disease (ESRD) or on chronic regular dialysis, presence of AKI and anuria at the time
<br> of ICU admission, history of chronic kidney disease, severe urinary tract infection,
<br> kidney malignancy, and renal transplantation.
<br> | | Biochemical Markers ,NGAL,Cystatin c, Acute Kidneyinjury, Covid 19 | Diagnostic Test: serum NGAL and cystatin c | measure both cystatin c and Neutrophil gelatinase-associated lipocalin every other day for 3 times (NGAL) as recent biomarkers in prediction of AKI in patients with COVID-19. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04611841 | 12 December 2020 | Medical-biological Research of the Pathogenesis of COVID-19 Disease Caused by SARS-CoV-2 | Medical-biological Research of the Pathogenesis of Disease Caused by SARS-CoV-2 | COV2020 | Federal Research and Clinical Center of Physical-Chemical Medicine | 26/09/2020 | 20200926 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04611841 | Recruiting | No | 18 Years | 75 Years | All | July 21, 2020 | 250 | Observational | | | Russian Federation | | Vadim Govorun, MD | | | | FRCC PCM |
<br> Inclusion Criteria:
<br>
<br> - Age over 18 and under 75 years old
<br>
<br> - COVID-19 diagnosis confirmed by PCR test
<br>
<br> - Written consent to participate in the study
<br>
<br> Exclusion Criteria:
<br>
<br> - Unwillingness or inability to give written informed consent to participate in the
<br> study
<br>
<br> - A serious condition with a threat to life or contraindications that prevent the
<br> collection of biomaterial
<br>
<br> - Oncological diseases outside the stage of remission
<br> | | Covid19 | | Analysis of the genetic variability of the SARS-CoV-2 virus, including the heterogeneity of the viral population in one patient;Metagenomic analysis of viral and bacterial respiratory flora of selected samples;Measurement of iron (Fe3+) content in blood plasma of patients infected with coronavirus;Revealing the degree of protein damage in the blood plasma of patients infected with coronavirus;Determination of the degree of oxidative damage to lipids (lipid peroxidation) in the blood plasma of patients infected with coronavirus;Determination of the presence of peptides of the SARS-CoV-2 virus in the plasma of patients diagnosed with COVID-19;Determination of antibody binding of patients diagnosed with COVID-19 to proteins of the SARS-CoV-2 virus | | | | Yes | False | | |
| → | NCT04613297 | 12 December 2020 | HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment | HLA-G Immuno-Inhibitor Checkpoint Study in Patients With COVID-19 Infection: Molecular and Cellular Assessment | HLA-G-COVID | Hopital Foch | 02/11/2020 | 20201102 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04613297 | Recruiting | No | 18 Years | N/A | All | October 19, 2020 | 120 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label). | N/A | France | ; ; | Olivier BRUGIERE, PhD;Olivier BRUGIERE, PhD;Olivier BRUGIERE, PhD | | ;o.brugiere@hopital-foch.com;o.brugiere@hopital-foch.com | ;0146253601;0146253601 | Hopital Foch; |
<br> Inclusion Criteria:
<br>
<br> - Patient with possible or confirmed infection by COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient without liberty or guardianship
<br> | | Covid19 | Other: Baseline and during hospitalization blood samples;Other: Baseline blood sample | Comparison of the expression of circulating soluble HLA-G, between the groups of patients.;Comparison of the percentage of T cells expressing the HLA-G receptor ILT2 (CD3+CD4+ILT2+ T cells, and CD3+CD8+ILT2+ T cells) between the 3 groups of patients.→Comparison of the percentage of T cells expressing the HLA-G receptor ILT2 (CD3+CD4+ILT2+ T cells, and CD3+CD8+ILT2+ T cells) between the 3 groups of patients.;Comparison of the expression of circulating soluble HLA-G, between the groups of patients. | | | | Yes | False | | |
| NCT04613310 | 12 December 2020 | PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2 (COVID-19) | PCR and Rapid Diagnostic Test on Saliva and Nasopharyngeal Swabs for the Detection of SARS-CoV-2: a Comparative Clinical Trial | RaDiCo | Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland | 26/10/2020 | 20201026 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04613310 | Recruiting | No | 18 Years | N/A | All | September 25, 2020 | 1250 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | Switzerland | ; ; | Valérie D'Acremont, MD PhD;Valérie D'Acremont, MD PhD;Valerie D'Acremont, MD-PhD | | ;valerie.dacremont@unisante.ch;valerie.dacremont@unisante.ch | ;+41 79 556 25 51;+41 79 556 25 51 | Unisanté; |
<br> Inclusion Criteria:
<br>
<br> - Outpatient aged above 18 years who reports having at least one of the following symptoms:
<br> reported cough, reported fever, reported anosmia, or reported ageusia
<br>
<br> Exclusion Criteria:
<br>
<br> - Unwilling or incapable of informed consent
<br>
<br> - Hospitalized patients
<br>
<br> - Anticoagulation
<br> | | COVID-19;SARS-CoV-2 | Diagnostic Test: Rapid Diagnostic Test vs PCR | Proportion of SARS-CoV-2 positive patients for the two different sampling types (saliva vs nasopharyngeal) and two methods (RDT vs PCR) . | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| IRCT20201004048923N1 | 5 January 2021 | Effect of biotin, brewer’s yeast and vitamin C supplements in patients with COVID-19 | Investigation of simultaneous administration of biotin, brewer’s yeast, and vitamin C supplements on the improvement of clinical symptoms in patients with COVID-19 | | Tehran University of Medical Sciences | 2020-12-13 | 20201213 | IRCT | http://en.irct.ir/trial/51442 | Recruiting | No | 20 years | 60 years | Male | 2020-10-15 | 50 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The stratification layer in this study is age. In order to allocate the same number of people in both groups, stratified randomization was used. Randomization of individuals into intervention and control groups was performed using a random number list created online by Random.org.This list is randomly divided between intervention and control groups from 1 to 50. | 3 | Iran (Islamic Republic of) | Dr Maliheh Paknejad | | Biochemistry department, Tehran university of Medical Sciences, Poursina St. Qods St. Enqelab St | paknejadma@tums.ac.ir | +98 21 6405 3295 | Tehran University of Medical Sciences | Inclusion criteria: Age between 20 to 60 years old<br>Male sex<br>COVID-19 patients with positive chest CT scan | Exclusion criteria: Infectious diseases, cancer and autoimmune diseases<br>Severe heart and liver diseases<br>Existence of severe clinical symptoms that require hospitalization<br>Diabetes | Coronavirus disease 2019 (COVID-19). <br>U07. 1;U07. 1 | Intervention 1: Intervention group: Patients in this group, addition to their routine treatment will receive; first day: two biotin tablets (5000 micrograms) simultaneously and after that with at least 6 hours, one another biotin tablet (5000 micrograms), second and third days: two biotin tablets (5,000 micrograms) with at least 8 hours interval. Fourth day up to the end of intervention: one biotin tablet (5,000 micrograms) daily. In addition to biotin, one effervescent tablet of vitamin C (500 mg) and two tablets of brewer's yeast will be received, daily up to the end of intervention. Intervention 2: Control group: Control group will receive only routine COVID-19 treatment. | Clinical symptoms improvement. Timepoint: At the beginning of the study (before the intervention) and after receiving supplements, daily. Method of measurement: Patient statements during the phone call and recording information according to the scoring system designed in the checklist. | | | | No | False | | |
| → | IRCT20201001048894N1 | 5 January 2021 | Effect of Interferon beta-1-b on COVID-19 patients | Evaluation of treatment regimen containing beta-1-b interferon on the COVID-19 patients with mild and severe symptoms and comparing it with interferon-free treatment regimen | | Bandare-abbas University of Medical Sciences | 2020-12-15 | 20201215 | IRCT | http://en.irct.ir/trial/51492 | Not Recruiting | No | no limit | no limit | Both | 2020-10-22 | 90 | interventional | Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. | 2-3 | Iran (Islamic Republic of) | Afshin Samiei | | Department of Immunology- Faculty of Medicine - Emam Hossein Blvd. - | afshin.samiei@gmail.com | +98 76 3371 0373 | Bandare-abbas University of Medical Sciences | Inclusion criteria: Positive result of Real time PCR<br>CT severity scoring<br>P o2 < 93mmHg<br>Respiratory rate more than 30 time per minute. | Exclusion criteria: Diabetes<br>Cardiac diseases<br>pregnancy<br>Malignancy<br>Consumption of corticosteroids | Covid 19. <br>Covid 19 , Virus Identified;U07.1 | Intervention 1: Intervention group: Subcutaneous administration of 250 microgram IFN beta-1-b every other day. Intervention 2: Control group: Control group will receive Covid-19 routine prescription. | CT severiity score. Timepoint: At the beginning and the end of study. Method of measurement: By CT scan.;ABG - Pao2. Timepoint: At the beginning and at the end of study. Method of measurement: ABG assay system.;D-dimer that is fibrin degradation product (FDP). Timepoint: At the beginning and at the end of study. Method of measurement: By ELISA.→D-dimer that is fibrin degradation product (FDP). Timepoint: At the beginning and at the end of study. Method of measurement: By ELISA.;ABG - Pao2. Timepoint: At the beginning and at the end of study. Method of measurement: ABG assay system.;CT severiity score. Timepoint: At the beginning and the end of study. Method of measurement: By CT scan. | | | | No | False | | |
| IRCT20181208041886N3 | 5 January 2021 | The effect of Montelukast on COVID 19 disease activity | Evaluation of the effect of Montelukast drug in improving the clinical condition of patients with COVID-19 in referral hospitals in Isfahan | | Abidi Pharmaceutical company | 2020-12-22 | 20201222 | IRCT | http://en.irct.ir/trial/51633 | Recruiting | No | 15 years | no limit | Both | 2020-12-21 | 60 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At first 15 block will be designed and these blocks, will divided to 3 groups as the mild (blocks 1 to 5 for patients with mild disease), moderate (blocks 6 to 10 for patients with moderate disease) and sever blocks (blocks 11 to 15 for patients with severe disease). After this designation in every block 4 blank will be designed for the patients as below:
Blank 1: Intervention by drug (Montelukast)
Blank 2: No intervention by the drug
Blank 3: Intervention by the drug (Montelukast)
Blank 4: No intervention by the drug
In approach to every patient (out patient and/or inpatient) at first he/she will be selected on the inclusion and exclusion criteria and after getting informed consent he/she will be classified as the patient with mild, moderate and sever disease. Then the patient will be placed in the empty blank in his/her own block and wil | 3 | Iran (Islamic Republic of) | Morteza Pourahmad | | Sofeh Street | mortezapourahmad@yahoo.com | +98 31 3322 0996 | Esfahan University of Medical Sciences | Inclusion criteria: Every patient with diagnosis of COVID-19<br>Mild, moderate and severe stage of the disease | Exclusion criteria: No complete consent and compliace of the patient for study<br>Follow up of the patient not be possible<br>The age below 15 years old<br>Rifampin and Phenobarbital consumers | COVID-19. <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: the patients with diagnosis of COVID-19 will be treated by tablet Montelukast 10 mg. This treatment will be in addition to standard therapies for these patients. The drug is in tablet and oral form which will be administered once a day and for 14 days. We will use Airokast tablet which is made by Dr. Abidi pharmaceutical company in Iran. Intervention 2: Control group: the patient with diagnosis of COVID-19 will give the standard therapies and without Montelukast. | Discontinuation of fever. Timepoint: Daily till 14 days. Method of measurement: Measurement of temperature by digital infrared thermometer, and the O2 saturation by pulseoximeter.;Decreased Respiratory Rate. Timepoint: Daily till 14 days. Method of measurement: Measurement of fever by a termometer, and O2 saturation by pulse Oximetery.;Decreased Cough. Timepoint: Daily till 14 days. Method of measurement: Body temperature by thermometer, O2 sat by pulseoximetery.;Evaluation of blood O2 Saturation. Timepoint: Daily till 14 days. Method of measurement: Physician evaluation by Puls oxymetery. | | | | No | False | | |
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| IRCT20100130003227N15 | 5 January 2021 | The effect of Hyssop and Verbascum herbal tea on clinical symptoms of Covide-19. | The effect of Hyssop and Verbascum herbal tea on clinical symptoms of Covide-19. | | Khomein Medical University | 2020-12-10 | 20201210 | IRCT | http://en.irct.ir/trial/52719 | Recruiting | No | 18 years | 65 years | Both | 2020-12-21 | 50 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method and description: The randomization method is based on gradual references and having the inclusion criteria and interest in participating in the study.
Randomization unit: Man
Random layers:
Material of randomization tool: Random number table
How to build a random sequence: Sequence
Allocation concealment: The subjects are randomly assigned to two groups (intervention and control) using a table of random numbers. The randomization sequence will be generated based on 4 random permutation blocks using a web-based software (from website: https://www.sealedenvelope.com). The randomization sequence will be provided to the project manager and will be hidden from the person participating in the study and the evaluator's colleague to enter the study until the intervention, Blinding description: Blinding in this study was double-bli | N/A | Iran (Islamic Republic of) | Mohammad Taheri | | Qods Boulevard | rheum.nursing@gmail.com | +98 86 4622 1533 | Khomein School of Medical Sciences | Inclusion criteria: Patients who are clinically proven by PCR and different views on CT scan ( With the confirmation of an infectious disease specialist).<br>Clinically be in moderate and severe groups.<br>Without organ damage.<br>Age over 18 years.<br>Be in a stable cardiovascular condition. | Exclusion criteria: Patient death during study<br>Reluctance to continue cooperation<br>Occurrence of any allergies following the use of plants<br>Patient treated with chemotherapy or radiotherapy<br>History of cancer<br>History of chronic autoimmune diseases<br>People with seizures and epilepsy<br>Nervous patients<br>Pregnancy<br>Breastfeeding<br>End Stage<br>People with chronic kidney failure<br>Liver failure<br>Encephalopathy<br>Neuropathy | Covid-19. <br>Covid-19;U07.1 | Intervention 1: "Intervention group": Using the Hyssop (30 grams in 24 hours) and Verbscum (15 grams in 24 hours) herbal tea three times a day (For 7 to 10 days) for patients with Covid 19 disease along with commonly used treatments such as: Favipiravir, Recigen, Tocilizumabe, Dexamethasone, Methylprednisolone, Doxycycline, Meropenem, Ceftriaxone, Levofloxacin, Salbutamol spray, Atrovent spray, Seroflu spray and etc. Intervention 2: Control group: Use of common drugs for the treatment of Covid 19 disease such as: Favipiravir, Recigen, Tocilizumabe, Dexamethasone, Methylprednisolone, Doxycycline, Meropenem, Ceftriaxone, Levofloxacin, Salbutamol spray, Atrovent spray, Seroflu spray and etc. | Improvement the symptoms of Covide-19disease. Timepoint: Seventh and tenth day. Method of measurement: Intensity of cough- Intensity of shortness of breath- O2 Saturation- Duration of hospitalization in the ward- Respiration Rate- Three-dimensional CT scan changes of the lungs- CBC.diff and ESR and CRP. | | | | Yes | False | | |
| → | IRCT20190415043279N9 | 5 January 2021 | Evaluation of the effect of Propolis COVID 19 | Evaluation of the effect of Propolis on the recovery process of COVID 19 patients | | Sanandaj University of Medical Sciences | 2020-12-22 | 20201222 | IRCT | http://en.irct.ir/trial/52853 | Recruiting | No | no limit | no limit | Both | 2020-12-05 | 72 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using block randomization method with a block size of 4. Sampling method at this study will be according to random allocation. Participants will enter the study according to inclusion criteria, and then will be divided into two groups according to randomization table. One group will receive Propolis Capsule and the other will receive placebo. The participants and administrator do not have any information about content of capsules (double blinded study). The list of randomization was computer-generated. supplements and placebo capsules were placed in completely identical packages and were coded by someone who was unaware of the nature of the study in numbered bottles based on the list. And another person who was unaware of the contents of the pack provided them to the patients, Blinding description: All supplements and placebo capsules were identi | 3 | Iran (Islamic Republic of) | Vahid Yousefinejad | | Kurdistan University of Medical Sciences, Pasdaran Blvd, Sanandaj, Iran | hooman56y@yahoo.com | +98 87 3366 4645 | Sanandaj University of Medical Sciences | Inclusion criteria: Definitive confirmation of Covid 19 based on RT-PCR results<br>Hospitalized patients<br>Ventilator independent patients | Exclusion criteria: Pregnancy<br>Breastfeeding<br>Type 1 diabetes<br>Severe renal failure<br>Metabolic acidosis<br>Severe respiratory failure<br>Chemotherapy recipients<br>Taking anticoagulants | Covid-19. <br>Other coronavirus as the cause of diseases classified elsewhere;U07.1 | Intervention 1: Intervention group: Propolis capsules are taken in the form of 500 mg capsules (made by Shahdineh Golha Company) twice a day for 14 days. Intervention 2: Control group: The placebo is taken as a capsule Twice a day for 14 days. | Need for intubation. Timepoint: Daily since hospitalization. Method of measurement: Patient's ?le.;Need for ICU. Timepoint: Daily since hospitalization. Method of measurement: Patient's ?le.;Duration of hospitalization. Timepoint: Daily since hospitalization. Method of measurement: Counting the day.;IL-6. Timepoint: At the end of the intervention. Method of measurement: ELISA kit.;Body Mass Index (BMI). Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: by measuring height and weight using a scale and height meter.;Sore throat. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;Headache. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;Shortness of breath. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;Loss of Smell and Taste. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;Anorexia. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;Gastrointestinal symptoms. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;CT scan findings. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: CT scan.;Lactate Dehydrogenase. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Autoanalyzer.;Erythrocyte sedimentation rate (ESR). Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: ESR device.;Heart Rate. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Pulse oximeter.;Respiratory Rate. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: By observing the occurrence of breaths.;Blood oxygen saturation percentage. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Pulse oximeter.;C Reactive Protein. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Agglutination.;Muscle pain. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;Cough. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;CBC. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Cell Counter.;Fever. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Thermometer.→Fever. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Thermometer.;CBC. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Cell Counter.;Cough. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;Muscle pain. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;C Reactive Protein. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Agglutination.;Blood oxygen saturation percentage. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Pulse oximeter.;Respiratory Rate. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: By observing the occurrence of breaths.;Need for intubation. Timepoint: Daily since hospitalization. Method of measurement: Patient's ?le.;Need for ICU. Timepoint: Daily since hospitalization. Method of measurement: Patient's ?le.;Duration of hospitalization. Timepoint: Daily since hospitalization. Method of measurement: Counting the day.;IL-6. Timepoint: At the end of the intervention. Method of measurement: ELISA kit.;Body Mass Index (BMI). Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: by measuring height and weight using a scale and height meter.;Sore throat. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;Headache. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;Shortness of breath. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;Loss of Smell and Taste. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;Anorexia. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;Gastrointestinal symptoms. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Questionnaire.;CT scan findings. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: CT scan.;Lactate Dehydrogenase. Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: Autoanalyzer.;Erythrocyte sedimentation rate (ESR). Timepoint: At the beginning of the study (before the intervention) and after the intervention. Method of measurement: ESR device.;Heart Rate. Timepoint: At the beginning of the study (before the intervention), days 3, 5, 7 and after the intervention. Method of measurement: Pulse oximeter. | | | | No | False | | |
| IRCT20170218032635N3 | 5 January 2021 | The efficacy of mindfulness based stress reduction program on mental well-being and quality of life in patients with COVID-19 after discharge | The efficacy of mindfulness based stress reduction program on mental well-being and quality of life in patients with COVID-19 after discharge: A Randomized Control Trial | | Tarbiat Modares University | 2020-12-27 | 20201227 | IRCT | http://en.irct.ir/trial/53134 | Not Recruiting | No | 18 years | 60 years | Both | 2021-01-20 | 100 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: A quadruple block will be used to randomly assign samples to the test and control groups. Using the website, we will have a randomization list of 25 blocks of four in the form of AABB and other modes, and we will group one letter for the intervention group and one letter for the test group - according to the list.
https://www.sealedenvelope.com/simple-randomiser/v1/lists. | N/A | Iran (Islamic Republic of) | Afsaneh Sadooghiasl | | Chamran highway.Jalal al ahmed | asadooghi@tums.ac.ir | +98 21 8288 4875 | Tarbiat Modares University | Inclusion criteria: Age of 18-60<br>Literacy and the ability to communicate verbally<br>Willingness and ability to participate in mindfulness-based stress reduction virtual sessions<br>Ability to use virtual space and messengers<br>The ability of performing individual daily activities | Exclusion criteria: Changing the patient's health status that prevents his continued participation in the study.<br>Failure to attend meetings and follow up the intervention<br>Changing the patient's condition and re-hospitalization<br>The event of an unintended accident for a person (occurrence of a new physical problem, mental and psychological problem, death of a loved one) that affects the quality of life and well-being of the person. | Condition 1: stress. Condition 2: covid-19. <br>Acute stress reaction <br>Coronavirus infection, unspecified;F43.0;B34.2 | Intervention 1: Intervention group: The intervention in this study is a mindfulness-based stress reduction program that will be a 90-minute mindfulness-based treatment in 8 individual sessions over two months (one 90-minute session per week). The written exercises and audio files of each session will be delivered to the participants at the end of that session. If necessary, group meetings will be conducted virtually via internal messengers. The researcher (clinical psychologist) will review the homework of each participant and will review and fix the problems related to it. After the training, the researcher will review the exercises of all the participants case by case and They will correct possible shortcomings. Each session will conclude with a review of what went on in the session, as well as a summary of the content of the session and the assignment of homework. The intervention will take 2 months. Two months after the end of the intervention, the tools will be completed again by both groups. Intervention 2: Control group: They will receive routine care after discharge from the hospital. | Quality of life. Timepoint: before intervention and 8 weeks after finishing intervention. Method of measurement: World Health Organization Quality Of Life- BREF.;Psychological well being. Timepoint: before intervention and 8 weeks after finishing intervention. Method of measurement: Ryff's psychological well being scale. | | | | Yes | False | | |
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| EUCTR2020-001921-30-IT | 5 January 2021 | Steroids and unfractionated heparin in critically-ill patients with pneumonia from COVID-19 infection. A multicenter, interventional, randomized, three arms study design. | Steroids and unfractionated heparin in critically-ill patients with pneumonia from COVID-19 infection. A multicenter, interventional, randomized, three arms study design. - Steroids and unfractionated heparin in critically-ill patients with pneumonia from COVID-19 infectio | | AZIENDA OSPEDALIERO-UNIVERSITARIA POLICLINICO DI MODENA | 26/06/2020 | 20200626 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001921-30 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 14/05/2020 | 200 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 3
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Italy | Clinical Trials Quality Team | | Via del Pozzo 71 | mighali.pasquale@aou.mo.it | 0594224369 | Azienda Ospedaliero-Universitaria di Modena | Inclusion criteria: <br>- Positive SARS-CoV-2 diagnostic (on pharyngeal swab of deep airways material)<br>- Positive pressure ventilation (either non-invasive or invasive) from > 24 hours<br>- Invasive mechanical ventilation from < 96 hours<br>- P/F ratio < 150<br>- D-dimer level > 6 x upper limit of local reference range<br>- PCR > 6 fold upper limit of local reference range<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 126<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 84<br> | Exclusion criteria: <br>- Age <18 years<br>- On-going treatment with anticoagulant drugs<br>- Platelet count < 100.000/mmc<br> - History of heparin-induced thrombocytopenia<br>- Allergy to sodium enoxaparine or other LMWH, unfractionated heparin or metylprednisolone;<br>- Active bleeding or on-going clinical condition deemed at high risk of bleeding contraindicating anticoagulant treatment<br>- Recent (in the last 1 month prior to randomization) brain, spinal or ophthalmic surgery<br>- Chronic assumption or oral corticosteroids<br>- Pregnancy or breastfeeding or positive pregnancy test. In childbearing age women, before inclusion, a pregnancy test will be performed if not available;<br>- Clinical decision to withhold life-sustaining treatment or “too sick to benefit”;<br>- Presence of other severe diseases impairing life expectancy (e.g. patients are not expected to survive 28 days given their pre-existing medical condition);<br>- Lack or withdrawal of informed consent.<br> | critically-ill patients with pneumonia from COVID-19 infection <br>MedDRA version: 23.0
Level: LLT
Classification code 10053983
Term: Corona virus infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: SOLU MEDROL<br>Product Name: Metilprednisolone sodio succinato<br>Product Code: [-]<br>Pharmaceutical Form: Powder and solvent for solution for injection<br>INN or Proposed INN: METILPREDNISOLONE<br>Current Sponsor code: -<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: range<br>Concentration number: 125-1000<br><br>Trade Name: VERACER<br>Product Name: VERACER<br>Product Code: [-]<br>Pharmaceutical Form: Concentrate for solution for injection<br>INN or Proposed INN: EPARINA<br>Current Sponsor code: -<br>Concentration unit: IU international unit(s)<br>Concentration type: equal<br>Concentration number: 25000-<br><br>Trade Name: inhixa<br>Product Name: enoxaparina sodica<br>Product Code: [-]<br>Pharmaceutical Form: Concentrate for solution for injection<br>INN or Proposed INN: EPARINA SODICA<br>Current Sponsor code: -<br>Concentration unit: IU international unit(s)<br>Concentration type: equal<br>Concentration number: 2000-<br><br> | Timepoint(s) of evaluation of this end point: 28 day;Primary end point(s): All-cause mortality at day 28;Secondary Objective: -;Main Objective: The primary objective is to assess the hypothesis that an adjunctive therapy with steroids and unfractionated heparin or with steroids and molecular weight heparin (LMWH) are more effective in reducing any-cause mortality in critically-ill patients with pneumonia from COVID- 19 infection compared to low molecular weight heparin (LMWH) alone. Mortality will be measured at 28 days.<br>The confirmation of the efficacy of this composite treatment in reducing the mortality rate among critically ill patients with pneumonia from COVID-19 infection will lead to a revision of the current clinical approach to this disease. | | | | No | False | | |
| → | EUCTR2020-004285-19-IT | 5 January 2021 | Evaluation of Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 | A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic Strategies in Hospitalized Adults with COVID-19 - ACTIVE4-ACUTE | | CONSORZIO FUTURO IN RICERCA | 23/11/2020 | 20201123 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004285-19 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 25/11/2020 | 2000 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: yes
Other trial design description: ADAPTIVE RANDOMIZED PLATFORM TRIAL
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| United States;Italy | CONSORZIO FUTURO IN RICERCA | | Via Giuseppe Saragat | cfr@unife.it | | CONSORZIO FUTURO IN RICERCA | Inclusion criteria: <br>= 18 years of age<br>Hospitalized for COVID-19*<br>Enrolled within 72 hours of hospital admittance or 72 hours of positive COVID test<br>Expected to require hospitalization for > 72 hours<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 2000<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 2000<br> | Exclusion criteria: <br>Imminent death<br>Requirement for chronic mechanical ventilation via tracheostomy prior to hospitalization<br>Pregnancy<br> | Patients hospitalized for COVID-19 and enrolled within 72 hours of hospital admittance or 72 hours of positive COVID test <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
<br>MedDRA version: 23.0
Level: LLT
Classification code 10053983
Term: Corona virus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: EPARINA<br>Product Code: [B01AB01]<br>Pharmaceutical Form: <br>Current Sponsor code: EPARINA NON FRAZIONATA<br>Concentration unit: IU/ml international unit(s)/millilitre<br>Concentration type: equal<br>Concentration number: 5000-<br><br>Product Name: DELTAPARINA<br>Product Code: [B01AB04]<br>Pharmaceutical Form: Solution for injection<br>Current Sponsor code: DALTEPARINA<br>Concentration unit: IU/ml international unit(s)/millilitre<br>Concentration type: equal<br>Concentration number: 25000-<br><br>Product Name: ENOXPARIN<br>Product Code: [B01AB05]<br>Pharmaceutical Form: Solution for injection<br>Current Sponsor code: ENOXAPARINA<br>Concentration unit: IU/ml international unit(s)/millilitre<br>Concentration type: equal<br>Concentration number: 10000-<br><br> | Secondary Objective: A composite endpoint of death, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, or ischemic stroke during hospitalization or at 28 days after enrollment (whichever is earlier);Main Objective: 21 Day Organ-Support free-days.;Timepoint(s) of evaluation of this end point: 21 days from inclusion;Primary end point(s): 21 Day Organ-Support free-days.→Secondary Objective: A composite endpoint of death, pulmonary embolism, systemic arterial thromboembolism, myocardial infarction, or ischemic stroke during hospitalization or at 28 days after enrollment (whichever is earlier);Main Objective: 21 Day Organ-Support free-days.;Primary end point(s): 21 Day Organ-Support free-days.;Timepoint(s) of evaluation of this end point: 21 days from inclusion | | | | Yes | False | | |
| EUCTR2020-001645-40-IT | 5 January 2021 | Reparixin in COVID-19 pneumonia | Adaptive phase 2/3, randomized, controlled multicenter study on the efficacy and safety of Reparixin in the treatment of hospitalized patients with COVID-19 pneumonia - REPAVID-19 | | DOMPé FARMACEUTICI S.P.A. | 22/09/2020 | 20200922 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001645-40 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 06/05/2020 | 159 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Standard of care
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Italy | Flavio Mantelli | | Via Santa Lucia, 6 | flavio.mantelli@dompe.com | 0258383324 | Dompé farmaceutici S.p.A. | Inclusion criteria: <br>- Phase 2 Inclusion Criteria:<br>1. Age 18 to 90.<br>2. Confirmed COVID-19 diagnosis<br>3. At least one of the following: 1. Respiratory distress, RR => 30 breaths/min without oxygen; 2. Partial arterial oxygen pressure (PaO2) / Fraction of inspiration O2 (FiO2) >100 <300mmHg (1mmHg = 0.133kPa).<br>4. Chest imaging confirms lung involvement and inflammation.<br>5. Inflammatory status as documented by at least one of the following: Lactate dehydrogenase (LDH) > normal range, C-reactive protein (CRP) => 100mg/L or IL-6 => 40pg/mL, serum ferritin => 900ng/mL, XDP >20mcg/mL.<br>- Phase 3 Inclusion Criteria: Same as above; other criteria TBD based on Phase 2 outcomes.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 79<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 80<br> | Exclusion criteria: <br>- Phase 2/3 Exclusion Criteria:<br>1. Cannot obtain informed consent.<br>2. Severe hepatic dysfunction (Child Pugh score => C, or AST> 5 times the upper limit); Severe renal dysfunction (estimated glomerular filtration rate <= 30mL / min / 1.73 m2) or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.<br>3. Patients with hypersensitivity to ibuprofen or to more than one non steroidal anti-inflammatory drug or to more than one medication belonging to the class of sulfonamides (e.g. sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or celecoxib; hypersensitivity to sulphanilamide antibiotics alone, e.g. sulfamethoxazole, does not qualify for exclusion) <br>4. Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervous system bleeding, and nosebleeds within 1 month before enrollment.<br>5. Pregnant and lactating women and those planning to get pregnant.<br>6. Participated in other interventional clinical trials with investigational medicinal products, not considered suitable for this study by the researchers.<br>7. At the time of enrollment, patients not in a clinical condition compatible with the oral administration of the study drug.<br> | COVID-19 pneumonia <br>MedDRA version: 20.0
Level: HLGT
Classification code 10047438
Term: Viral infectious disorders
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Reparixin<br>Product Code: [DF1681Y]<br>Pharmaceutical Form: Concentrate for solution for injection/infusion<br>INN or Proposed INN: REPARIXIN<br>CAS Number: 266359-83-5<br>Current Sponsor code: DF1681Y<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 33-<br><br>Product Name: Reparixin<br>Product Code: [DF1681Y]<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: REPARIXIN<br>CAS Number: 266359-83-5<br>Current Sponsor code: DF1681Y<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1200-<br><br> | Timepoint(s) of evaluation of this end point: -;Primary end point(s): - Phase 2 Primary Endpoint: Composite endpoint of clinical events (the patient requires at least one of the following: supplemental oxygen requirement, mechanical ventilation use, admission to Intensive Care Unit (ICU), and use of a rescue medication for any reason)<br>- Phase 3 Primary Endpoint: Composite endpoint of death and of severe clinical events (the patient dies or requires mechanical ventilation use and/or admission to ICU);Secondary Objective: Please refer to protocol;Main Objective: - Phase 2 Study Objectives: efficacy and safety of Reparixin as compared to the control arm in adult patients with severe COVID-19 pneumonia<br>- Phase 3 Study Objectives: efficacy and safety of Reparixin treatment as compared to the control arm in adult patients with severe COVID-19 pneumonia | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04466982 | 11 January 2021 | Assessment of Olfactory Dysfunction in SARS CoV-2 (COVID-19) Infection | Objective Assessment of Olfactory Dysfunction and Impact on Quality of Life in SARS CoV-2 (COVID-19)Infection Using the UPSIT, eQOD and SNOT-22 Questionnaires: A Prospective Observational Cohort Study | ODYSSI | Cambridge University Hospitals NHS Foundation Trust | 09/07/2020 | 20200709 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04466982 | Recruiting | No | 18 Years | 85 Years | All | July 2, 2020 | 90 | Observational | | | United Kingdom | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Patients who are presenting to hospital with symptoms of SARS CoV-2 infection.
<br>
<br> - Patients who go on to develop a positive SARS CoV-2 test.
<br>
<br> - Patients who can give a valid written informed consent.
<br>
<br> - Patients who are motivated to participate in the study.
<br>
<br> - Adult patients aged 18 years - 85 years.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who cannot give a valid written informed consent.
<br>
<br> - Patients who are not willing or not motivated to participate in the study.
<br>
<br> - Patients with negative SARS CoV-2 tests.
<br>
<br> - Patients with nasal pathologies like severe deviated nasal septum, nasal masses, head
<br> trauma or previously known chronic rhinosinusitis with polyps or on medication for
<br> more than 6 months/year for at least one year for chronic rhinosinusitis.
<br>
<br> - Patients with any diagnosed neurological disease known to affect olfactory function
<br> will be excluded from the study.
<br>
<br> - Patients unable to read in the English language.
<br> | | Olfactory Disorder;COVID19;SARS-CoV-2;Anosmia;Microsomia;Smell Disorder;Quality of Life | | UPSIT scores | | | | Yes | False | | |
| → | NCT04476745 | 11 January 2021 | The Effect of D3 on Selected Cytokines Involved in Cytokine Storm in the Covid-19 Uninfected Jordanian People | The Effect of Weekly 50,000 IU Vitamin D3 Supplements on the Serum Levels of Selected Cytokines Involved in Cytokine Storm of Covid-19; A Randomized Clinical Trial in the Covid-19 Uninfected Jordanian People With Vitamin D Deficiency | | Applied Science Private University | 16/07/2020 | 20200716 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04476745 | Recruiting | No | 30 Years | 66 Years | All | October 5, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | Jordan | ; | Mahmoud S Abu-Samak, PhD;Dana A Bader, MSc | | ; | ; | Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan;Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan |
<br> Inclusion Criteria:
<br>
<br> Age =30 years old Male and female Jordanian ASU students and employees who live in Amman.
<br> Informed written consent from the participant prior to the start of the study. a serum
<br> 25(OH)D concentration less than 30 ng/mL.
<br>
<br> Exclusion Criteria:
<br>
<br> Any eligible subject refuses to apply with informed written consent before the start of the
<br> study. Men or women previously diagnosed with chronic diseases, including kidney disease or
<br> GIT problems. Who are receiving vitamin D3 supplements (3 months before the start of the
<br> study). Pregnant, Breastfeeding females, Females using hormonal contraceptives
<br> | | Cytokine Storm | Dietary Supplement: Vitamin D3 | TNF;IL-1 beta;IL-6→TNF;IL-6;IL-1 beta | | | | Yes | False | | |
| NCT04483271 | 11 January 2021 | The Effect of Omega-3 on Selected Cytokines Involved in Cytokine Storm | The Effect of Omega-3 Supplements on the Serum Levels of Selected Cytokines Involved in Cytokine Storm of Covid-19; A Randomized Clinical Trial in the Covid-19 Uninfected Jordanian People | | Applied Science Private University | 18/07/2020 | 20200718 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04483271 | Recruiting | No | 30 Years | 66 Years | All | October 2, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | Jordan | ; | Mahmoud S Abu-Samak, PhD;Rafeef A Al-Khaled, MSC | | ; | ; | Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan;Department of Clinical Pharmacy and Therapeutics , Applied Science Private University, Amman -Jordan |
<br> Inclusion Criteria:
<br>
<br> - Inclusion criteria included males and females in the age range of 30-66 years without
<br> a medical diagnosis of COVID-19 infection.
<br>
<br> Exclusion Criteria:
<br>
<br> - Exclusion criteria included males or females diagnosed with any chronic immune
<br> problems, including autoimmune diseases, chronic or severe infections.
<br>
<br> - Pregnant, breastfeeding, and females using hormonal contraceptives were also excluded.
<br> | | Cytokine Storm;Cytokines | Dietary Supplement: 300 mg of omega3-FA | TNF alpha;IL-6;IL-1 beta | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04542226 | 11 January 2021 | Observational Open Study of Polyoxidonium in Hospitalized Patients With COVID-19 | Open Observational Study of Efficacy and Safety of Polyoxidonium in Complex Therapy of Hospitalized Patients With COVID-19 | | NPO Petrovax | 08/09/2020 | 20200908 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04542226 | Not recruiting | No | 18 Years | N/A | All | March 31, 2020 | 81 | Observational | | | Russian Federation;Belarus;Russian Federation;Belarus | | Nikolay S. Dodonov | | | | NPO Petrovax |
<br> Inclusion Criteria:
<br>
<br> 1. The hospitalized patient was administered Polyoxidonium, according to the instruction
<br> for medical usage in complex with Russian MoH guidance for treatment of COVID-19.
<br>
<br> 2. Verified coronavirus disease COVID-19, and at least one of the following:
<br>
<br> - severe disease: mechanical ventilation or oxygen supply required with blood
<br> oxygen saturation (SpO2) = 94% on room air or tachypnea, respiratory rate = 24
<br> breaths per minute,
<br>
<br> - mild-moderate disease: SpO2 > 94% on room air or respiratory rate < 24 breaths
<br> per minute.
<br>
<br> 3. The patient signed an Informed Consent form for participation in this study.
<br>
<br> 4. The patient can understand all protocol requirements, perform the study procedures,
<br> and agree to all limitations specified in the protocol.
<br>
<br> 5. Male and female patients from 18 years of age.
<br>
<br> 6. Confirmed diagnosis of coronavirus disease (COVID-19): laboratory-confirmed Severe
<br> acute respiratory syndrome-related coronavirus 2 (SARS-CoV-2) infection as determined
<br> by polymerase chain reaction (PCR), or other commercial or public health assay in any
<br> specimen prior to inclusion.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnancy or breastfeeding.
<br>
<br> 2. Pathological condition that the study doctor considers significant enough to prevent
<br> enrolment of this patient.
<br>
<br> 3. Participation in any clinical study within 30 days before the Informed Consent form
<br> provided.
<br>
<br> 4. Hypersensitivity and/or intolerability to any ingredient of the investigational
<br> product.
<br>
<br> 5. Acute or chronic renal failure.
<br> | | Infections, Coronavirus | Drug: Polyoxidonium | Clinical Status of the Patient (According to 7-point Ordinal Scale) | 03/12/2020 | | https://clinicaltrials.gov/ct2/show/results/NCT04542226 | Yes | False | | Yes |
| → | NCT04552366 | 11 January 2021 | A Clinical Trial of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults | A Clinical Trial to Evaluate the Safety and Immunogenicity of a Recombinant Adenovirus 5 Vectored COVID-19 Vaccine (Ad5-nCoV) With Two Doses in Healthy Adults Aged 18 Years and Older | | Institute of Biotechnology, Academy of Military Medical Sciences, PLA of China | 15/09/2020 | 20200915 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04552366 | Not recruiting | No | 18 Years | N/A | All | September 29, 2020 | 149 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1 | China | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Aged 18 years and older;
<br>
<br> - Able to provide consent to participate in and having signed an Informed Consent Form
<br> (ICF);
<br>
<br> - Able and willing to complete all the scheduled study procedures during the whole study
<br> follow-up period (about 6-8 months, depending on group);
<br>
<br> - Negative result of HIV screening;
<br>
<br> - Axillary temperature =37.0°C.
<br>
<br> - Negative IgG and IgM antibodies against COVID-19;
<br>
<br> - Good general health status, as determined by history and physical examination.
<br>
<br> Exclusion Criteria for the first vaccination:
<br>
<br> - Hematological examination is abnormal, or clinically significant as assessed by the
<br> study investigator (including white blood cell count, lymphocyte count, neutrophil
<br> count, eosinophil count, platelet, hemoglobin, alanine aminotransferase (ALT),
<br> aspartate aminotransferase (AST), total bilirubin, blood glucose and creatinine);
<br>
<br> - With oral ulcers, throat swelling and other oral diseases.
<br>
<br> - With symptoms of upper respiratory tract infection.
<br>
<br> - Personal history of seizure disorder, encephalopathy or psychosis;
<br>
<br> - Allergic history to any vaccine, or allergic to any ingredient of the Ad5-nCoV;
<br>
<br> - Any acute febrile disease or active infectious disease on the day of vaccination;
<br>
<br> - History of SARS or COVID-19;
<br>
<br> - History of COVID-19 candidate vaccine administration;
<br>
<br> - History of chronic obstructive pulmonary disease (COPD).
<br>
<br> - Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial
<br> infarction, severe hypertension not controlled with medication;
<br>
<br> - Serious chronic disease or in the advanced stage that cannot be controlled well, such
<br> as asthma, diabetes and thyroid disease, etc.;
<br>
<br> - Congenital or acquired angioedema;
<br>
<br> - Suffered from urticaria within 1 year before receiving the trial vaccine.
<br>
<br> - Asplenia or functional asplenia;
<br>
<br> - Platelet disorder or other bleeding disorder that may cause intramuscular injection
<br> contraindication;
<br>
<br> - Faint with needles in intramuscular administration group;
<br>
<br> - Immunosuppressive medication, anti-allergic, cytotoxic therapy, inhaled
<br> corticosteroids (excluding surface corticosteroid therapy for acute non-complicated
<br> dermatitis) in the last 6 months;
<br>
<br> - Prior administration of blood products in last 4 months;
<br>
<br> - Other vaccination(s) or investigational drugs within 1 month before study onset;
<br>
<br> - Prior administration of live attenuated vaccine within 1 month before study onset;
<br>
<br> - Prior administration of subunit or inactivated vaccine within 14 days before study
<br> onset;
<br>
<br> - Current anti-tuberculosis therapy;
<br>
<br> - Woman is pregnant or lactating, positive urine pregnancy test or plan to become
<br> pregnant during the next 8 months;
<br>
<br> - Any condition that in the opinion of the investigators may interfere with the
<br> participants' compliance or evaluation of study objectives or informed consent (i.e.
<br> medical, psychological, social or other conditions, etc.).
<br>
<br> Exclusion Criteria for the second vaccination:
<br>
<br> - Severe allergic reaction after the first dose of vaccination;
<br>
<br> - Severe adverse reactions causally related to the first vaccination;
<br>
<br> - For those newly discovered or newly occured after the first vaccination that does not
<br> meet the first-dose selection criteria or meets the first-dose exclusion criteria, the
<br> investigator will determine whether to continue participating in the study;
<br>
<br> - Other reasons for exclusion as deemed by the investigator.
<br> | | COVID-19 | Biological: Ad5-nCoV | Geomean titers of the neutralizing antibody against SARS-CoV-2;Seroconversion rate of the neutralizing antibody against SARS-CoV-2;Geomean titers of the IgG antibody against SARS-CoV-2;Seroconversion rate of the IgG antibody against SARS-CoV-2;Incidence of the AE in all groups→Geomean titers of the neutralizing antibody against SARS-CoV-2;Seroconversion rate of the neutralizing antibody against SARS-CoV-2;Seroconversion rate of the IgG antibody against SARS-CoV-2;Incidence of the AE in all groups;Geomean titers of the IgG antibody against SARS-CoV-2 | | | | Yes | False | | |
| NCT04553055 | 11 January 2021 | Antibiotic Misuse During COVID-19 Pandemic | Assessment of Community Pharmacies Related Antibiotic Misuse and Application of Infection Control Measures During COVID-19 Pandemic | | Beni-Suef University | 15/09/2020 | 20200915 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04553055 | Not recruiting | No | 20 Years | N/A | All | July 20, 2020 | 413 | Observational [Patient Registry] | | | Egypt | | Hoda M Rabie, PHD | | | | lecturer |
<br> Inclusion Criteria:
<br>
<br> - All community pharmacists worked during the pandemic and dealt with covid-19 patients
<br> inside their pharmacies are welcomed to participate
<br>
<br> Exclusion Criteria:
<br>
<br> - Clinical and hospital pharmacists- other medical staff- pharmacist assistant
<br> | | Covid19 | Other: online questionnaires | antibiotic misuse | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04584658 | 11 January 2021 | Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19) Infection (DYADS Study) | Dysphagia and Dysphonia Outcomes in SARS CoV-2 (COVID-19): A Prospective Observational Cohort Study. | DYADS | Cambridge University Hospitals NHS Foundation Trust | 10/10/2020 | 20201010 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04584658 | Recruiting | No | 18 Years | 85 Years | All | September 15, 2020 | 36 | Observational | | | United Kingdom | | Rachel Kyd | | rachel.kyd@addenbrookes.nhs.uk | 01223 245151 | |
<br> Inclusion Criteria:
<br>
<br> - Patients who have been diagnosed with a positive SARS CoV-2 test.
<br>
<br> - Patients who have been diagnosed with dysphonia and/or dysphagia following COVID 19
<br> treatment.
<br>
<br> - Patients who require investigation and management for dysphonia and/or dysphagia
<br> following COVID 19 treatment.
<br>
<br> - Adult patients aged 18 years - 85 years.
<br>
<br> - Patients that meet threshold for referral to the joint MDT clinic following screening
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who cannot undertake the assessment for dysphonia and/or dysphagia.
<br>
<br> - Patients who are being managed with palliative intent.
<br>
<br> - Patients with pre-existing dysphonia and/or dysphagia not previously responding to
<br> therapy (pre-existing prior to COVID-19 diagnosis).
<br> | | Dysphagia;Dysphonia;Subglottic Stenosis;Voice Disorders;Swallowing Disorder;Covid19;SARS (Severe Acute Respiratory Syndrome);SARS Pneumonia;Quality of Life;SARS-CoV-2 Infection | Diagnostic Test: Fibreoptic Endoscopic Evaluation of Swallowing (FEES);Diagnostic Test: Videofluoroscopy;Other: Dysphagia Handicap Index (DHI);Other: Voice Symptom Scale (VoiSS) | Primary endpoint is severity of dysphonia and dysphagia at the time of initial assessment t = day 0 (for ITU patients: Day 0 = 24 hours after extubation or decannulation). | | | | Yes | False | | |
| → | NCT04603690 | 11 January 2021 | Study to Investigate the Benefits of Colchicine in Patients With COVID-19 | A Randomized, Open-labeled, and Controlled Trial to Study the Benefits of Colchicine in Patients With COVID-19 | | Liaquat University of Medical & Health Sciences | 24/10/2020 | 20201024 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04603690 | Not recruiting | No | 18 Years | N/A | All | December 15, 2020 | 0 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. SARS-CoV-2 infection confirmed by PCR.
<br>
<br> 2. Admitted in the hospital in the previous 48 hours, with clinical status 3, 4 or 5 of
<br> WHO classification.
<br>
<br> 3. Age above 18 years old.
<br>
<br> 4. Informed written consent.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Invasive mechanical ventilation needed.
<br>
<br> 2. Established limitation of the therapeutic effort
<br>
<br> 3. Inflammatory bowel disease (IBD: Chron Syndrome or Ulcerative colitis), chronic
<br> diarrhea or malabsorption.
<br>
<br> 4. Previous neuromuscular disease.
<br>
<br> 5. Other disease with an estimated vital prognosis under 1 year.
<br>
<br> 6. Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
<br>
<br> 7. Medical records of cirrhosis, active chronic hepatitis or severe hepatic disease
<br> defined by GOT or GPT levels three times above the normal upper limit.
<br>
<br> 8. Patients with previous colchicine treatment for other diseases (mainly chronic
<br> prescriptions for familial Mediterranean fever or gout). Clearance period will not be
<br> required for patients treated with colchicine who stopped the treatment before the
<br> randomization.
<br>
<br> 9. Patients with history of allergic reaction or significant sensitivity to colchicine.
<br>
<br> 10. Treatment with immunosuppressive agents, corticoids or interleukine-1 antagonists for
<br> 6 months before inclusion.
<br>
<br> 11. Pregnant or breastfeeding female, confirmed by a positive result in the human
<br> chorionic gonadotropin (hCG) test.
<br>
<br> 12. Fertile woman, or post-menopausal during less than one year and non-surgically
<br> sterilized. Women of fertile age may be included if using at least one contraceptive
<br> method and preferably two complementary contraceptive methods.
<br>
<br> 13. Use of other investigational drugs in the moment of inclusion, or during 30 days
<br> previous to inclusion.
<br> | | Covid-19 | Drug: Colchicine | Improvement in the clinical status;Changes in IL-6 concentrations→Changes in IL-6 concentrations;Improvement in the clinical status | | | | Yes | False | | |
| NCT04605965 | 11 January 2021 | WEAICOR: Wearables to Investigate the Long Term Cardiovascular and Behavioral Impacts of COVID-19 | Wearable Health Data to Investigate Long-term Cardiovascular and Behavioral Health Outcomes in COVID-19 Patients After Discharge: The WEAICOR Study | WEAICOR | Tulane University | 12/08/2020 | 20200812 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04605965 | Recruiting | No | 18 Years | 120 Years | All | June 9, 2020 | 100 | Observational [Patient Registry] | | | United States | ; | Nassir Marrouche, MD;Agniezska Drutel, PhD | | ;ajezierskadrutel@tulane.edu | ;(504)988-6443 | Tulane University School of Medicine; |
<br> Inclusion Criteria:
<br>
<br> - Positive COVID-19 diagnosis
<br>
<br> - Ages 18 to 120
<br>
<br> - Access to WiFi
<br>
<br> Exclusion Criteria:
<br>
<br> - Negative COVID-19 diagnosis
<br>
<br> - Age younger than 18 and older than 120
<br>
<br> - Lack of access to WiFi
<br> | | Covid19;Cardiovascular Complication;Behavioral Changes | | Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of nicotine products survey;Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of drugs survey;Mental health effect of COVID-19 measured by incidence of substance abuse using a baseline use of alcohol survey;Mental health effect of COVID-19 measured by incidence of Post Traumatic Stress Syndrome (PTSD) using the Post Traumatic Stress Disorder Checklist- Standard Form (PCL-S) scale;Mental health effect of COVID-19 measured by incidence of depression using Beck Depression Fast Screen Scale;Mental health effect of COVID-19 measured by incidence of Generalized Anxiety Disorder (GAD) using Generalized Anxiety Disorder 7-item (GAD-7) Scale;Incidence of atrial arrhythmia;Incidence of major cardiovascular events | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| ChiCTR2000039000 | 11 January 2021 | A Phase III clinical trial for inactivated novel coronavirus pneumonia (COVID-19) vaccine (Vero cells) | Randomized, double-blinded, placebo parallel-controlled phase III clinical trial to evaluate the Immunogenicity and safety of the inactivated SARS-CoV-2 Vaccine (Vero cell) in healthy population aged 18 years and above | | China National Biotec Group Co.Ltd | 2020-10-13 | 20201013 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=62581 | Recruiting | No | 18 | | Both | 2020-09-02 | placebo group:300;vaccine group:300; | Interventional study | Parallel | 3 | Morocco | Professeur Abouqal Redouane | | Ibn Sina Hospital BP1005 Rabat,Kingdom of Morocco | rabouqal@gmail.com | +212-661224739 | Ibn Sina Hospital | Inclusion criteria: 1. Age range: healthy people aged 18 and above;
<br>2. Medical history and physical examination were inquired, and the researcher judged that he was in good health;
<br>3. Female subjects of childbearing age were not pregnant (negative urine pregnancy test), were not in lactation and had no family planning in the first 3 months after enrollment; effective contraceptive measures were taken in the first 2 weeks before enrollment;
<br>4. The subjects who are able and willing to complete the whole research plan during the whole follow-up period;
<br>5. The subjects have the ability to understand the research procedure, and voluntarily sign the informed consent after informed consent, and can comply with the requirements of the clinical research protocol. | Exclusion criteria: 1. Novel coronavirus infection confirmed cases;
<br>2. History of SARS and mers infection (self report, on-site inquiry);
<br>3. Fever (axillary temperature > 37.0 degrees C), dry cough, fatigue, nasal obstruction, runny nose, sore throat, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before inoculation;
<br>4. The axillary temperature was more than 37.0 degrees C before inoculation;
<br>5. Novel coronavirus inactivated vaccine has been sensitization to severe allergic reactions (such as acute allergic reaction, urticaria, eczema, dyspnea, neurovascular edema or abdominal pain).
<br>6. History of convulsion, epilepsy, encephalopathy or mental illness or family history;
<br>7. Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc;
<br>8. Severe liver and kidney diseases, drug uncontrollable hypertension (systolic blood pressure >= 140 mmHg, diastolic blood pressure >= 90 mmHg), diabetic complications, malignant tumor, acute attack of various acute or chronic diseases;
<br>9. Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
<br>10. Known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors;
<br>11. History of coagulation dysfunction (such as coagulation factor deficiency, coagulation diseases);
<br>12. Receiving anti TB treatment;
<br>13. Those who received immunoenhancement or immunosuppressive therapy within 3 months (continued oral or drip for more than 14 days);
<br>14. Vaccinated with live attenuated vaccine within one month before vaccination and other vaccines within 14 days before vaccination;
<br>15. Received blood products within 3 months before vaccination;
<br>16. Received other research drugs within 6 months before vaccination;
<br>17. The researcher judged other situations not suitable to participate in this clinical trial;
<br>18. Severe allergic reaction and high fever (axillary temperature >= 39.0 degrees C) lasting for three days after the previous dose of vaccination;
<br>19. Serious adverse reactions related to the previous dose of vaccination;
<br>20. Reach the end of the study;
<br>21. The researcher shall decide whether to continue to participate in the study if the new discovery or occurrence after the previous dose of vaccine does not meet the inclusion criteria of the first dose or meets the exclusion criteria of the first dose;
<br>22. Other exclusion reasons considered by researchers;
<br>23. If any of the following occurs during the trial, the relevant subjects are not required to stop the trial:
<br>-Non specific immunoglobulins were used during the study;
<br>-Continuous oral or drip steroid hormone for 14 days.
<br>24. Items 18-23 above are the exclusion criteria for the second dose. | Novel coronavirus Pneumonia (COVID-19) | placebo group:placebo;vaccine group:vaccine; | To evaluate the 4-fold increase rate, GMT and GMI of anti-SARS-CoV-2 neutralizing antibody 28 days after full course of immunization; | | | | No | False | | |
| → | EUCTR2020-001370-30-FR | 11 January 2021 | Study of efficacy and safety of canakinumab treatment for CRS in participants with COVID-19-induced pneumonia. | Phase 3 multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of canakinumab on cytokine release syndrome in patients with COVID-19-induced pneumonia (CAN-COVID). | | Novartis Pharma AG | 16/04/2020 | 20200416 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001370-30 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 12/05/2020 | 450 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Italy;United Kingdom;Germany;Spain;Hungary;France;United States | Information&Communication Médicales | | 8-10 rue Henri Sainte-Claire Deville | icm.phfr@novartis.com | +33155 47 66 00 | Novartis Pharma S.A.S. | Inclusion criteria: <br>1. Male or female
<br>2. Adults (= 18 years old)
<br>3. Body weight =40 kg
<br>4. Informed consent must be obtained prior to participation in this study.
<br>5. Clinically diagnosed with SARS-CoV-2 virus by PCR or by other approved diagnostic methodology within 7 days prior to randomization
<br>6. Hospitalized with COVID-19-induced pneumonia evidenced by chest x-ray or CT scan (taken within 5 days prior to randomization) with pulmonary infiltrates
<br>7. SpO2 = 93% on room air or arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg (1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions (over 1000m))
<br>8. C-reactive protein =20 mg/L or ferritin level =600 µg/L<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 405<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 45<br> | Exclusion criteria: <br>1. History of hypersensitivity to canakinumab or to biologic drugs
<br>2. Intubated and on mechanical ventilation (invasive) at time of randomization
<br>3. Treatment with biologic immunomodulators or immunosuppressant drugs, including but not limited to anakinra, tocilizumab, TNF inhibitors and anti-IL-17 agents within 5 half-lives prior to randomization. Note: Immunomodulators (topical or inhaled) for asthma and atopic dermatitis and corticosteroids are not restricted.
<br>4. Suspected or known untreated active bacterial, fungal, viral, or parasitic infection with the exception of COVID-19
<br>5. Neutropenia with ANC <1000/mm3
<br>6. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator’s judgment, precludes the patient’s safe participation in and completion of the study
<br>7. In the opinion of the investigator, progression to death is imminent and highly likely within the next 24 hours, irrespective of the provision of treatments
<br>8. Current participation in any other investigational trials.<br> | COVID-19-induced pneumonia (CAN-COVID) <br>MedDRA version: 20.1
Level: PT
Classification code 10053983
Term: Corona virus infection
System Organ Class: 10021881 - Infections and infestations
| <br>Trade Name: Ilaris<br>Product Name: Canakinumab<br>Product Code: ACZ885<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: CANAKINUMAB<br>CAS Number: 914613-48-2<br>Current Sponsor code: CACZ885D2310<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intravenous use<br><br> | Timepoint(s) of evaluation of this end point: Day 29;Primary end point(s): Clinical response, defined as survival without ever requiring invasive mechanical ventilation from Day 3 (inclusive) up to Day 29 (inclusive). ;Secondary Objective: - To demonstrate the benefit of canakinumab in reducing 4-week case fatality rate (CFR) among patients with COVID-19-induced pneumonia and CRS regardless of other subsequent clinical interventions<br>- To evaluate change in clinical serologic measurements related to CRS in COVID-19 patients with pneumonia<br>- To evaluate safety of canakinumab in patients with COVID-19-induced pneumonia and CRS.;Main Objective: To demonstrate the benefit of canakinumab + SOC in increasing chance of survival without ever requiring invasive mechanical ventilation among patients with COVID-19-induced pneumonia and CRS.→Timepoint(s) of evaluation of this end point: Day 29;Primary end point(s): Clinical response, defined as survival without ever requiring invasive mechanical ventilation from Day 3 (inclusive) up to Day 29 (inclusive). ;Main Objective: To demonstrate the benefit of canakinumab + SOC in increasing chance of survival without ever requiring invasive mechanical ventilation among patients with COVID-19-induced pneumonia and CRS.;Secondary Objective: - To demonstrate the benefit of canakinumab in reducing 4-week case fatality rate (CFR) among patients with COVID-19-induced pneumonia and CRS regardless of other subsequent clinical interventions<br>- To evaluate change in clinical serologic measurements related to CRS in COVID-19 patients with pneumonia<br>- To evaluate safety of canakinumab in patients with COVID-19-induced pneumonia and CRS. | | | | Yes | True | parent | |
| → | EUCTR2020-002259-39-HU | 11 January 2021 | This global, multicenter, Phase 1/2, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of adding TL-895 treatment to standard available therapy (SAT) in subjects with cancer hospitalized for COVID-19. | A Phase 1/2, Double-Blind, Randomized, Placebo-Controlled Study of TL-895 with Standard Available Treatment versus Standard Available Treatment for the Treatment of COVID-19 in Patients with Cancer | | Telios Pharma, Inc. | 26/08/2020 | 20200826 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002259-39 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 28/09/2020 | 146 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: yes<br>Other specify the comparator: standard available therapy (SAT)<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany;Peru;Brazil;Argentina;Hungary;France;United Kingdom;Italy;Russian Federation;Ukraine;Spain;Philippines;United States→United States;Philippines;Spain;Ukraine;Russian Federation;Italy;United Kingdom;France;Hungary;Argentina;Brazil;Peru;Germany | Associate Director, Regulatory | | 275 Shoreline Drive, Suite 325 | jbockhorn@teliospharma.com | 312-208-7486 | Telios Pharma, Inc. | Inclusion criteria: <br>1. Adults =18 years of age<br>2. Known diagnosis of active cancer that is not considered cured or disease free.<br>3. Confirmed COVID-19 infection as per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [e.g., respiratory, blood, urine, stool, or other bodily fluid] within 3 weeks of Cycle 1 Day 1) with suspected pneumonia requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen<br>4. Adequate hematological function independent of growth factor support for at least 7 days with the exception of pegylated G-CSF and darbepoetin which require at least 14 days, defined as<br>a. Absolute neutrophil count (ANC) = 1.0 × 109/L for subjects with solid malignancies. ANC = 0.75 × 109/L for subjects with hematologic malignancies<br>b. Platelet count = 75 × 109/L for subjects with solid malignancies. Platelet count = 50 × 109/L for subjects with hematologic malignancies<br>5. Adequate hepatic function defined by:<br>a. Total bilirubin within normal limits, if total bilirubin is >upper limit of normal (ULN), then subjects are eligible if the direct bilirubin =2.0 × ULN<br>b. Aspartate aminotransferase (AST) = 2.5 × ULN, and alanine aminotransferase (ALT) = 2.5 × ULN.<br>6. Adequate renal function defined by an estimated creatinine clearance = 30 mL/min according Cockcroft Gault<br>7. Ability to swallow and absorb oral medications<br>8. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, must both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 67<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 79<br> | Exclusion criteria: <br>1. Subjects with a life expectancy of less than 6 months<br>2. No remaining available therapies for advanced or metastatic malignancies<br>3. Subjects with an advanced healthcare directive that includes a do not intubate (DNI) or do not resuscitate (DNR) orders.<br>5. Subjects who require chemotherapy due to active oncologic disease that cannot be suspended while receiving study treatment.<br>6. Subjects with new onset malignancy who require urgent systemic therapy because of active oncologic disease<br>7. Subjects who received systemic chemotherapy resulting in immunosuppression within 14 days of Cycle 1 Day 1.<br>8. Active treatment with immunomodulator medications including immune checkpoint inhibitors (PD-1, PD-L1, CTLA4 blockers) that could not be suspended for the duration of the study.<br>9. Subjects who received prior anti-cytokine therapy (anti-IL-6) within 5 half-lives of the drug from Cycle 1 Day 1.<br>10. Participation in another clinical study with therapeutic intent for COVID-19. The only exception is that patients participating in clinical trials receiving hydroxychloroquine or chloroquine and/or azithromycin and/or remdesivir will be allowed<br>11. Patients on warfarin at study entry<br>12. Patients on combined anti-platelet and therapeutic anti-coagulation therapy (LMWH or DOAC).<br>13. Myocardial infarct within 6 months, unstable angina, uncontrolled cardiac arrhythmia, or New York Heart Association (NYHA) class 3/4 heart failure<br>14. Requirement for artificial ventilation (HFNC, NiPPV, ECMO, or intubation and MV) at screening<br>15. Known bleeding disorders (e.g., Von Willebrand’s disease, platelet storage pool disorders, or hemophilia)<br>16. Stroke or intracranial hemorrhage within 6 months of Cycle 1 Day 1<br>17. Women who are pregnant or breastfeeding<br>18. Requires treatment with proton-pump inhibitors (e.g., omeprazole, esomeprazole, lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving proton-pump inhibitors who switch to H2-receptor antagonists or antacids are eligible for enrollment in this study.<br>19. Subjects with active hepatitis B virus (HBV) or hepatitis C virus (HCV)<br>20. Subjects with known history of human immunodeficiency virus (HIV)<br>21. Grade 2 or higher QTc prolongation (> 480 milliseconds per National Cancer Institute Common Terminology of Adverse Events [v 5.0])<br>22. Disease significantly affecting gastrointestinal function and/or inhibiting small intestine absorption (malabsorption syndrome, resection of the small bowel, poorly controlled inflammatory bowel disease, etc.)<br>23. Patients receiving radiation therapy to the lung or mediastinum for treatment of COVID-19<br>24. Untreated or actively progressing known CNS lesions (carcinomatous meningitis). Patients with a history of CNS lesions are eligible, provided that all of the following criteria are met:<br>– All known CNS lesions have been treated with radiotherapy or surgery.<br>– Any radiotherapy or surgery must be completed = 4 weeks prior to initiation of study treatment.<br>– No history of intracranial hemorrhage from CNS lesions<br> | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in patients with cancer <br>MedDRA version: 23.0
Level: LLT
Classification code 10084270
Term: SARS-CoV-2 acute respiratory disease
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: TL-895<br>Product Code: TL-895<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: TL-895<br>CAS Number: 1415823-49-2<br>Current Sponsor code: TL-895<br>Other descriptive name: M7583<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 50-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: Day 29;Primary end point(s): Part 1: DLTs will be used to establish the RP2D.<br>Part 2: The proportion of subjects per arm requiring artificial ventilation (intubation and mechanical ventilation [MV], extracorporeal membrane oxygenation [ECMO], heated, humidified high-flow nasal cannula oxygen [HFNC], noninvasive positive pressure ventilation [NiPPV]) or death from Day 1 through Day 29 of study treatment.<br>;Secondary Objective: Part 1: <br>-To determine whether TL-895 can diminish the need for artificial ventilation or death<br>-To determine whether TL-895 decreases respiratory failure events that require invasive ventilation or death<br>-To determine the time to hospital discharge<br>-To examine the 1- and 3-months overall survival<br>-To determine the proportion of subjects with viral clearance at time of hospital discharge and post discharge<br>-To determine toxicity observed in subjects treated with TL-895<br>-To characterize the pharmacokinetic profile of TL-895<br><br>Part 2:<br>-To determine whether TL-895 plus SAT (Arm 1) can diminish the need for artificial ventilation or death as compared to placebo plus SAT (Arm 2) during the study<br>-To determine whether Arm 1 decreases respiratory failure events that require invasive ventilation or death as compared to Arm 2 during the study.<br>-To determine the time to hospital discharge for subjects treated with Arm 1 versus Arm 2<br>see Protocol for full list of Secondary objectives ;Main Objective: Part 1: To evaluate the safety and tolerability of TL-895 in COVID-19 infected subjects and determine the recommended Phase 2 dose (RP2D)<br>Part 2: To determine whether TL-895 plus standard available therapy (SAT) (Arm 1) can diminish the need for artificial ventilation or death as compared to placebo plus SAT (Arm 2) from Day 1 through Day 29 of study treatment | | | | Yes | True | parent | |
| EUCTR2020-002234-32-IT | 11 January 2021 | Efficacy and Safety of Edoxaban and or Colchicine for patients with SARS-CoV-2 infection managed in the out of hospital setting (COVID 19) | Efficacy and Safety of Edoxaban and or Colchicine for patients with SARS-CoV-2 infection managed in the out of hospital setting (COVID 19) - CorONa Virus edoxabaN ColchicinE (CONVINCE) | | INSEL GRUPPE AG, BERN UNIVERSITY HOSPITAL, DEPARTMENT OF CARDIOLOGY | 04/01/2021 | 20210104 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002234-32 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 28/12/2020 | 420 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 4<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Italy;Switzerland;Belgium;Spain | Cardiologia | | Freiburgstrasse, 8 | marco.valgimigli@insel.ch | +41316325492 | Insel Gruppe AG, Bern University Hospital Department of Cardiology | Inclusion criteria: <br>Patients >= 18 years old with symptoms compatible with active Coronavirus infection and laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital setting.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 300<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 120<br> | Exclusion criteria: <br>• Hepatic disease associated with coagulopathy and clinically relevant bleeding risk, including Child-Pugh C cirrhosis with portal hypertension.<br>• Lesion or condition, if considered to be a significant risk for major bleeding. This may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial haemorrhage, known or suspected oesophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities.<br>• Uncontrolled severe hypertension.<br>• Ongoing or planned treatment with parenteral or oral anticoagulants<br>• Unilateral or bilateral above knee lower extremity amputation.<br>• Inability to take oral medication or otherwise unable or unwilling to undergo/perform study-specified procedures<br>• Have received or will receive an experimental drug or used an experimental medical device within 30 days before the planned start of treatment<br>• Pregnancy or breast-feeding or any plan to become pregnant during the study. Women (and men, for Colchicine group only) with child-bearing potential not using adequate birth control method (note: as adequate method of birth control oral contraception is recommended. If oral contraception is not feasible, both partners should use adequate barrier birth control).<br>• Need for dual anti-platelet therapy consisting of aspirin and an oral P2Y12 inhibitor <br>• Inflammatory bowel disease or chronic diarrhea or neuromuscular disease<br>• Creatinine clearance (CrCl) <15 ml/min<br>• Anticipated use of Hydroxychloroquine<br>• Participation in any other clinical trial<br>• Inability to understand the requirements of the study and to provide informed consent<br> | Patients with laboratory confirmed SARS-CoV-2 infection (under RT PCR) who are managed at home or in another out-of-hospital setting. <br>MedDRA version: 23.0
Level: LLT
Classification code 10053983
Term: Corona virus infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Lixiana 30mg<br>Product Name: Edoxaban<br>Product Code: [Edoxaban]<br>Pharmaceutical Form: Film-coated tablet<br>CAS Number: 912273-65-5<br>Current Sponsor code: Edoxaban<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br>Trade Name: Colchicine<br>Product Name: Colchicine<br>Product Code: [M04AC01]<br>Pharmaceutical Form: Tablet<br>CAS Number: 64-86-8<br>Current Sponsor code: Colchicine<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 500-<br><br>Trade Name: Lixiana 60mg<br>Product Name: Edoxaban<br>Product Code: [Edoxaban]<br>Pharmaceutical Form: Film-coated tablet<br>CAS Number: 912273-65-5<br>Current Sponsor code: Edoxaban<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 60-<br><br> | Main Objective: The aim of the CONVINCE study is therefore to assess the safety and efficacy of edoxaban and/or colchicine administration in SARS-CoV-2 infected patients who are managed outside the hospital with respect to the occurrence of fatalities, hospitalisation, major vascular thrombotic events or the SARS-CoV-2 clearance rate under RT PCR;Secondary Objective: N.A.;Timepoint(s) of evaluation of this end point: 14 (+/-3) and 25 (+/-3) days;Primary end point(s): This study has 2 co-primary endpoints, one each randomization as follows:<br><br>Edoxaban vs. no active treatment<br>Major vascular thrombotic events (MVTE) at 25 (+/-3) days defined as a composite of:<br>• Asymptomatic proximal deep-vein thrombosis<br>• Symptomatic proximal or distal deep-vein thrombosis<br>• Symptomatic pulmonary embolism or thrombosis <br>• Myocardial infarction<br>• Ischemic stroke<br>• non-CNS systemic embolism<br>• Death<br><br>Colchicine vs no active treatment<br>The SARS-CoV-2 detection rates at day 14 (+/-3) under RT PCR or freedom from death or hospitalisation | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04345159 | 18 January 2021 | Association Between Long-term Hydroxychloroquine Treatment and Outcome of a History of Symptoms Suggestive of COVID-19 Infection During the Epidemic Period in France in Patients With Autoimmune Disease | Association Between Long-term Hydroxychloroquine Treatment and Outcome of a History of Symptoms Suggestive of COVID-19 Infection During the Epidemic Period in France in Patients With Autoimmune Disease | COVCALL | Fondation Ophtalmologique Adolphe de Rothschild | 10/04/2020 | 20200410 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04345159 | Not recruiting | No | 18 Years | N/A | All | April 17, 2020 | 572 | Observational | | | France | | Guillaume DEBELLEMANIERE, MD | | | | Fondation Adolphe de Rothschild |
<br> Inclusion Criteria:
<br>
<br> - History of Systemic Lupus Erythematosus, Rheumatoid arthritis, Sjogren's Syndrome or
<br> Psoriatic Arthritis.
<br>
<br> Exclusion Criteria:
<br>
<br> - beginning, or end, of an hydroxychloroquine treatment between Jan 1, 2020 and day of
<br> the phone call.
<br>
<br> - Bad treatment compliance
<br> | | SARS-CoV-2;Systemic Lupus Erythematosus;Rheumatoid Arthritis;Sjogren's Syndrome;Psoriatic Arthritis | Other: Questionnaire by phone call | Adjusted Odds Ratio | | | | Yes | False | | |
| → | NCT04366115 | 18 January 2021 | Evaluating AVM0703 for Treatment of COVID-19 or Influenza-mediated ARDS | A Randomized, Double-Blind, Placebo-Controlled, Phase 1 Study Evaluating AVM0703 in Patients With Acute Respiratory Distress Syndrome | AVM0703 | AVM Biotechnology LLC | 26/04/2020 | 20200426 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04366115 | Not recruiting | No | 18 Years | N/A | All | January 2021 | 16 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 1 | | | Madhavi Malladi, PhD | | M.Malladi@Medpace.com | 1.513-384-6717 | |
<br> Inclusion Criteria
<br>
<br> Patients who meet all of the following criteria will be eligible to participate in the
<br> study:
<br>
<br> 1. Age =18 years;
<br>
<br> 2. Must have laboratory confirmed COVID-19;
<br>
<br> 3. Must have moderate or severe, immediately life-threatening COVID-19 or Influenza (A or
<br> B), as follows:
<br>
<br> a. COVID-19 patients with ARDS (Berlin Criteria) as demonstrated by:
<br>
<br> i. Chest radiograph or CT scan showing bilateral opacities not fully explained by
<br> effusions, lobar/lung collapse, or nodules;
<br>
<br> ii. Respiratory failure not fully explained by cardiac failure or fluid overload; and
<br>
<br> iii. Impaired oxygenation defined as Moderate (partial pressure of oxygen
<br> [PaO2]:fraction of inspired oxygen [FiO2] ratio 100 mm Hg to <200 mm Hg with positive
<br> end-expiratory airway pressure [PEEP] >5 cm H2O) or Severe (PaO2:FiO2 ratio <100 mm Hg
<br> with PEEP>5 cm H2O) on more than 2 arterial blood gases at least 6 hours apart within
<br> a 24 hour period;
<br>
<br> b. Influenza (A or B) patients with ARDS (Berlin Criteria) as demonstrated by:
<br>
<br> i. Chest radiograph or CT scan showing bilateral opacities not fully explained by
<br> effusions, lobar/lung collapse, or nodules;
<br>
<br> ii. Respiratory failure not fully explained by cardiac failure or fluid overload; and
<br>
<br> iii. Impaired oxygenation defined as Severe (PaO2:FiO2 ratio<100 mm Hg with PEEP >5 cm
<br> H2O) on more than 2 arterial blood gases at least 6 hours apart within a 24 hour
<br> period;
<br>
<br> 4. Requires invasive mechanical ventilation or extracorporeal membrane oxygenation (ECMO)
<br> despite standard of care rescue measures (eg, prone positioning, and/or PEEP ladder,
<br> and/or inhaled pulmonary vasodilators, and/or recruitment maneuvers and/or
<br> neuromuscular blockade);
<br>
<br> 5. Females of childbearing potential must have a negative serum pregnancy test at
<br> screening;
<br>
<br> 6. Females of childbearing potential and nonsterile males must agree to use medically
<br> effective methods of contraception from the time of informed consent through 1 month
<br> after study drug infusion; and
<br>
<br> 7. Capable of providing informed consent, or if not capable, a legally authorized
<br> representative is capable of providing informed consent
<br>
<br> Exclusion Criteria
<br>
<br> Patients who meet any of the following criteria will be excluded from participation in the
<br> study:
<br>
<br> 1. Moribund patient who, in the opinion of the Investigator, is not expected to survive
<br> at least 24 hours;
<br>
<br> 2. Known hypersensitivity or allergy to the study drug or any of its excipients;
<br>
<br> 3. D-dimer level >3 times above normal range;
<br>
<br> 4. Known gastric or duodenal ulcer;
<br>
<br> 5. Uncontrolled type 1 or type 2 diabetes, per judgment of the Investigator;
<br>
<br> 6. Active and untreated bacterial, fungal, parasitic, or viral infection other than
<br> COVID-19 or Influenza (A or B). Patients with a history of a positive hepatitis B
<br> surface antigen and/or hepatitis B core antibody must have a negative hepatitis B
<br> polymerase chain reaction (PCR) assay result. Patients with history of a positive
<br> hepatitis C virus antibody test must have a negative hepatitis C PCR assay result;
<br>
<br> 7. Positive testing for tuberculosis during screening;
<br>
<br> 8. Known to have received a live vaccine within the previous 1 month;
<br>
<br> 9. Immunocompromised patients, defined as those who have received a bone marrow or solid
<br> organ transplant on immunosuppressive therapy; or history of human immunodeficiency
<br> virus (HIV) infection who have not been taking anti retroviral therapy for at least 6
<br> months before enrollment and/or with most recent CD4 count <200 cells/mL and/or most
<br> recent detectable viral load within the previous 6 months;
<br>
<br> 10. Moderate to End-stage liver disease (Childs-Pugh Score >10);
<br>
<br> 11. Dialysis-dependent due to underlying chronic renal disease. Note: patients who require
<br> dialysis for treatment of renal failure due to complications of COVID-19 or Influenza
<br> (A or B) infection are not excluded from enrollment;
<br>
<br> 12. Significant cardiovascular disease (eg, myocardial infarction, arterial
<br> thromboembolism, cerebrovascular thromboembolism) within 3 months prior to the start
<br> of AVM0703 administration, including: angina requiring therapy, symptomatic peripheral
<br> vascular disease, New York Heart Association Class III or IV congestive heart failure,
<br> left ventricular ejection fraction <30%, left ventricular fractional shortening <20%,
<br> or uncontrolled Grade 3 hypertension (diastolic blood pressure [DBP] >100 mm Hg or
<br> systolic blood pressure [SBP] >150 mm Hg) despite antihypertensive therapy.
<br>
<br> Note: patients with heart failure requiring medical support due solely to
<br> complications of COVID-19 infection are not excluded from enrollment;
<br>
<br> 13. Significant screening 12-lead ECG abnormalities, including unstable cardiac arrhythmia
<br> requiring medication, atrial fibrillation/flutter, left bundle-branch block, second
<br> degree atrioventricular (AV) block type 2, third-degree AV block, Grade 2 bradycardia,
<br> or heart rate corrected QT interval using Fridericia's formula average of triplicate
<br> ECGs >450 ms;
<br>
<br> 14. Manic-depressive disorder, schizophrenia, or a history of severe depression or
<br> substance abuse;
<br>
<br> 15. Pregnant or breastfeeding;
<br>
<br> 16. Concurrent enrollment in any other clinical study involving administration of a novel
<br> (ie, unapproved or not considered standard of care) investigational pharmacological
<br> agent(s). Concurrent enrollment in observational and device studies and studies
<br> involving administration of pharmacological agent(s) approved for other indications or
<br> considered emerging standard of care for treatment of COVID-19 (eg,
<br> hydroxychloroquine, remdesivir, low-dose dexamethasone), will be allowed if approved
<br> by the Sponsor;
<br>
<br> 17. Treatment with standard of care or off-label treatments for COVID-19 (eg, remdesivir),
<br> not administered as part of a formal clinical study, where the first dose was
<br> initiated within 72 hours of study drug start; and
<br>
<br> 18. Inability to obtain informed consent from the patient or legally authorized
<br> representative.
<br> | | ARDS;Covid19;Influenza, Human | Drug: AVM0703;Drug: Placebo | 28 day all-cause mortality will be a primary end point for Phase 1 and 2;Dose-Limiting Toxicities→Dose-Limiting Toxicities;28 day all-cause mortality will be a primary end point for Phase 1 and 2 | | | | Yes | False | | |
| NCT04373096 | 18 January 2021 | Enhanced Hood PPE to Minimize COVID-19 Transmission to Front-line Health Care Workers | Development of a Novel Hood Shield to Enhance PPE Security and Minimize COVID-19 Transmission to Front-line Health Care Workers Performing High-risk Procedures | | University Health Network, Toronto | 30/04/2020 | 20200430 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04373096 | Recruiting | No | 20 Years | 75 Years | All | December 7, 2020 | 42 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). | N/A | Canada | ; ; | Anahi Perlas, MD,FRCPC;Rongyu Jin;Rongyu (Cindy) Jin | | ;rongyu.jin@uhn.ca;rongyu.jin@uhn.ca | ;4166035800;416603-5800 | Toronto Western Hospital , UHN; |
<br> Inclusion Criteria:
<br>
<br> 1. Healthy, ASA 1-2 members of intubating team (staff anesthesiologists, fellows,
<br> anesthesia assistants, nurses) at the Toronto Western Hospital, University Health
<br> Network.
<br>
<br> 2. Age 20-75
<br>
<br> 3. Male or female
<br>
<br> Exclusion Criteria:
<br>
<br> a. Lack of a donning and doffing PPE training session at TWH in the last 6 months.
<br> | | Covid19 | Device: current IPAC-UHN PPE;Device: modified IPAC-UHN PPE | Incidence of contamination of any part of the base clothing or exposed skin of the upper body | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04574219 | 18 January 2021 | Virtual Parental Presence on Induction | Feasibility and Acceptability of Virtual Parental Presence on Induction of Anesthesia - Modernizing Solutions for Pediatric Anesthesia in Response to COVID-19 | VPPIA | Children's Hospital Medical Center, Cincinnati | 24/09/2020 | 20200924 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04574219 | Recruiting | No | 4 Years | 12 Years | All | November 3, 2020 | 184 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | United States;Canada;United States | ; | Vanessa Olbrecht, MD;Vanessa Olbrecht, MD | | ;vanessa.olbrecht@cchmc.org | ;513-636-4408 | Cincinnati Childrens Hospital Medical Center; |
<br> Inclusion Criteria:
<br>
<br> - Children from ages 4 years to 12 years old
<br>
<br> - ASA physical status I, II or III
<br>
<br> - Planned inhalational induction
<br>
<br> - Children presenting from home prior to surgery (not an inpatient)
<br>
<br> - English speaking parents and child
<br>
<br> Exclusion Criteria:
<br>
<br> - children with developmental delay
<br>
<br> - children with psychological / emotional disorders
<br>
<br> - children with altered mental status
<br>
<br> - children with language barrier
<br>
<br> - children who are not accompanied by someone able to consent (ie legal guardian)
<br>
<br> - children who are inpatient prior to surgery
<br>
<br> - children with expected difficult intubation/airway
<br>
<br> - children presenting for emergency surgery
<br>
<br> - family history or personal history of malignant hyperthermia / risk of MH
<br>
<br> - consent not obtained or withdrawl of consent
<br>
<br> - children with past history of violent behaviors during induction of anesthesia
<br>
<br> - cancellation of surgery
<br>
<br> - patients with a diagnosis of COVID-19 or a patient under investigation for COVID-19,
<br> including patients being treated with airborne precuations in the operating room
<br>
<br> - receipt of any type of medical sedative prior to induction of anesthesia, including
<br> (but not limited to) midazolam, ketamine, and/or dexmedetomidine.
<br> | | Anxiety;Surgery | Other: Use of Facetime with child and parents during induction | Assessment of parental presence with either Facetime, Skype or Teams;Operating room induction nurse satisfaction;Operating room induction nurse satisfaction;Operating room provider satisfaction;Operating room provider satisfaction;Parent satisfaction with virtual presence;Virtual presence cause delays in operating room | | | | Yes | False | | |
| → | NCT04590170 | 18 January 2021 | French Cohort of COVID-19 Patients With Post-intensive Care Syndrome | French Cohort of covid19 Patients With Post-intensive Care Syndrome : Rehabilitation From Intensive Care Unit to Home Return | COREADOM | Assistance Publique - Hôpitaux de Paris | 05/10/2020 | 20201005 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04590170 | Recruiting | No | 18 Years | N/A | All | October 30, 2020 | 100 | Observational | | | France | ; | Camille : Camille, MD;Marie-Martine Marie-Martine, MD, PhD | | ;marie-martine.lefevre-colau@aphp.fr | ;+33630480893 | Study Principal Investigator; |
<br> Inclusion Criteria:
<br>
<br> - COVID 19 infection (PCR or CT-scan)
<br>
<br> - ICU stay requiring mechanical ventilation
<br>
<br> - Age =18 years old
<br>
<br> Exclusion Criteria:
<br>
<br> - Inability to give consent
<br> | | Covid19 | Behavioral: Post-intensive Care unit syndrome | Change on Imagery cerebral;Change on physical Impairment neurologic exam;Change on physical Impairment Medical Research Council (MRC-SS MRC Sum score);Change on physical Impairment five times sit to stand test;Change on cognitive Impairment The Montreal Cognitive Assessment (MoCA);Cognitive Impairment Frontal Assessment Battery (FAB);Change on psychological Impairment : sadness;Change on psychological Impairment : anxiety;Change on psychological Impairment: Insomnia;Change on psychological Impairment : Apathy;Change on psychological Impairment : sideration;Change on psychological Impairment : Despair;Change on psychological Impairment : Culpability;Change on physical Impairment : sores;Change on physical Impairment autonomy for walking;Change on physical Impairment : autonomy for bed-chair transfers;Change on physical Impairment : stability of the trunk in siting;Change on physical Impairment : stiffness or pain involving joints;Change on physical Impairment: numeric verbal scales of pain;Change on physical impairment : numeric verbal scales of fatigue;Change on physical Impairment : electrocardiogram at rest;Change on physical Impairment : orthostatic hypotension;Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) on activity;Change on physical Impairment : respiratory rate on activity;Change on physical Impairment : ventilation mode;Change on physical Impairment : respiratory rate;Change on physical Impairment : cough;Change on physical Impairment: Modified Borg scale dyspnea score.;Change on physical Impairment : dyspnea;Change on cognitive Impairment: temporo-spatial disorientation;Change on cognitive Impairment : Introduction of neuroleptic;Change on cognitive Impairment: Delirium;Change on cognitive Impairment: Agitation;Change on cognitive Impairment: Communication;Change on cognitive Impairment: Cooperation;Change on cognitive Impairment: Vigilance (RASS);Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) at rest;Change on psychological Impairment : Conduit addictive;Change on psychological Impairment : psychiatric or psychologic care;assess type of psychiatric treatment;Change on psychological Impairment : Hospital Anxiety and Depression Scale (HADS);Change on psychological Impairment : Posttraumatic Stress Disorder Checklist Scale (PCL-S);assess psychological Impairment;assess psychological Impairment→Change on Imagery cerebral;Change on physical Impairment neurologic exam;Change on physical Impairment Medical Research Council (MRC-SS MRC Sum score);Change on physical Impairment five times sit to stand test;Change on cognitive Impairment The Montreal Cognitive Assessment (MoCA);Cognitive Impairment Frontal Assessment Battery (FAB);Change on psychological Impairment : sadness;Change on psychological Impairment : anxiety;Change on psychological Impairment: Insomnia;Change on psychological Impairment : Apathy;Change on psychological Impairment : sideration;Change on psychological Impairment : Despair;Change on psychological Impairment : Culpability;Change on physical Impairment : sores;Change on physical Impairment autonomy for walking;Change on physical Impairment : autonomy for bed-chair transfers;Change on physical Impairment : stability of the trunk in siting;Change on physical Impairment : stiffness or pain involving joints;Change on physical Impairment: numeric verbal scales of pain;Change on physical impairment : numeric verbal scales of fatigue;Change on physical Impairment : electrocardiogram at rest;Change on physical Impairment : orthostatic hypotension;Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) on activity;Change on physical Impairment : respiratory rate on activity;Change on physical Impairment : Peripheral capillary oxygen saturation (SpO2) at rest;Change on cognitive Impairment : Introduction of neuroleptic;Change on cognitive Impairment: Delirium;Change on cognitive Impairment: Agitation;Change on cognitive Impairment: Communication;Change on cognitive Impairment: Cooperation;Change on cognitive Impairment: Vigilance (RASS);Change on physical Impairment : ventilation mode;Change on physical Impairment : respiratory rate;Change on physical Impairment : cough;Change on physical Impairment: Modified Borg scale dyspnea score.;Change on physical Impairment : dyspnea;Change on cognitive Impairment: temporo-spatial disorientation;Change on psychological Impairment : Conduit addictive;Change on psychological Impairment : psychiatric or psychologic care;assess type of psychiatric treatment;Change on psychological Impairment : Hospital Anxiety and Depression Scale (HADS);Change on psychological Impairment : Posttraumatic Stress Disorder Checklist Scale (PCL-S);assess psychological Impairment;assess psychological Impairment | | | | Yes | False | | |
| NCT04603105 | 18 January 2021 | CCP Cancer UK Companion Study | Clinical Characterisation Protocol for Severe Emerging Infections in the UK (CCP-UK) - a Prospective Companion Study for Patients With Cancer and COVID-19 | | The Clatterbridge Cancer Centre NHS Foundation Trust | 09/10/2020 | 20201009 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04603105 | Not recruiting | No | N/A | N/A | All | February 28, 2021 | 9000 | Observational | | | | ; ; | Carlo Palmieri;Lance Turtle;Michael Stacckpoole, Bsc | | ;;ccpcanceruk@liverpool.ac.uk | ;;0151 795 7321 | Clatterbridge Cancer Centre NHS Foundation Trust;University of Liverpool; |
<br> Inclusion Criteria:
<br>
<br> - Patients with proven COVID-19 and a diagnosis of cancer who are enrolled into any Tier of
<br> the Principal CCP-UK protocol.
<br>
<br> Exclusion Criteria:
<br>
<br> - None in addition to those specified in the Principal CCP-UK protocol.
<br> | | Cancer;Covid19 | | To determine the COVID-19 fatality rate in different tumour types.;To determine the COVID-19 fatality rate overall in the cancer population using the most up to date dataset from the first wave. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04714125 | 25 January 2021 | Prognostic Value of Flow-mediated Dilation in Hospitalized COVID-19 Patients | Prognostic Value of Flow-mediated Dilation in Hospitalized Patients With SARS-CoV-2 Infection: an Observational Prospective Study | | University of Sao Paulo General Hospital | 14/01/2021 | 20210114 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04714125 | Recruiting | No | 18 Years | N/A | All | June 19, 2020 | 250 | Observational | | | Brazil | ; | Tiago Peçanha, PhD;Tiago Peçanha, PhD | | tiagopecanha@usp.br;tiagopecanha@usp.br | 11948243542;5511948243542 | |
<br> Inclusion Criteria:
<br>
<br> - Patients diagnosed with SARS-CoV-2
<br>
<br> - Recently admitted to the hospital (= 72 hours)
<br>
<br> - Not yet proceeded to ICU care
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients transferred from other hospitals
<br>
<br> - Participants in delirium state
<br>
<br> - Participants with a recent history of endotracheal intubation
<br> | | Covid19;SARS-CoV Infection | | Composite outcome | | | | No | False | | |
| → | NCT04714515 | 25 January 2021 | Montelukast - a Treatment Choice for COVID-19 | Using Montelukast to Treat the Patients Infected With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | | University of Sargodha | 19/09/2020 | 20200919 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04714515 | Not recruiting | No | 20 Years | 80 Years | All | February 20, 2020 | 150 | Observational | | | Pakistan;China;Pakistan;China | ; | Wei Zhang, MD;Muhammad Rehman Akram, MBBS | | ; | ; | Department of Critical Care Medicine, Shanghai General Hospital, Shanghai Jiao Tong University, School of Medicine, Shanghai, China;Shaukat Khanum Memorial Cancer Hospital & Research Centre, Johar Town, Lahore, Pakistan |
<br> Inclusion Criteria:
<br>
<br> - Patients with diagnosed COVID-19
<br>
<br> - Patients who are not directly admitted to ICU
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients, who were already on immunosuppressants
<br>
<br> - Patients with age > 80
<br>
<br> - Patient with any known allergies to montelukast
<br> | | Covid19;SARS-CoV-2 Infection | Drug: Montelukast;Drug: Hydroxychloroquine;Drug: Ivermectin | Patients admittance to ICU;Alleviating the symptoms of COVID-19;Length of total stay at the hospital→Alleviating the symptoms of COVID-19;Length of total stay at the hospital;Patients admittance to ICU | | | | Yes | False | | |
| NCT04715360 | 25 January 2021 | Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy | Management of Cytokine Storms in Severe COVID-19 Patients With Autologous Activated Platelet-rich Plasma Therapy | | Hayandra Peduli Foundation | 15/01/2021 | 20210115 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04715360 | Recruiting | No | 18 Years | 65 Years | All | December 29, 2020 | 30 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | Phase 1/Phase 2 | Indonesia | ; ; | Louis Martin Christoffel, MD;Karina Karina, MD, PhD;Louis Martin Christoffel, MD | | ;karina@hayandra.com;louischristoffel200@gmail.com | ;62.21.3909333;6281340062037 | Koja Regional Public Hospital; |
<br> Inclusion Criteria:
<br>
<br> - severe covid-19 patient in ICU
<br>
<br> Exclusion Criteria:
<br>
<br> - CKD on hemodialysis, HIV positive, hepatitis, pregnant, destroyed lung, cancer
<br> | | Covid19;Sars-CoV-2 Infection;ARDS, Human;Severe covid19 | Combination Product: autologous activated platelet-rich plasma;Drug: Avigan | Effect of aaPRP on CRP level before and after intervention compared to control.;Effect of aaPRP on overall adverse event related to the treatment.;to evaluate the change of Effect of aaPRP on anti-inflammatory cytokines plasma level (IL-1RA, IL-4, IL-10) before and after intervention compared to control.;Effect of aaPRP on pro-inflammatory cytokines plasma level (IL-6, IL-1B, TNFa, IFN gamma, MCP-1) before and after intervention compared to control. | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| JPRN-UMIN000042939 | 25 January 2021 | Establishment of endobarrier during screening esophagogastroduodenoscopy during COVID-19 pandemic | Efficacy of endobarrier for preventing aerosol transmission of esophagogastroduodenoscopy during COVID-19 pandemic: A quantitative analys - Efficacy of endobarrier for preventing aerosol transmission of esophagogastroduodenoscopy: A quantitative analys | | Kagawa University, Faculty of Medicine, Department of Gastroenterology and Neurology | 10/01/2021 | 20210110 | JPRN | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049014 | Recruiting | No | 18years-old | 95years-old | Male and Female | 2021/01/07 | 100 | Observational | Not selected Not selected | Not selected | Japan | Hideki | Kobara | 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa Prefecture, 761-0793 Japan | kobara@med.kagawa-u.ac.jp | 0878912156 | Kagawa University, Faculty of Medicine Department of Gastroenterology and Neurology | Inclusion criteria: | Exclusion criteria: 1. Patients who need emergency endoscopic treatment such as gastrointestinal bleeding<br>2. Patients with psychiatric diseases or psychiatric symptoms who are judged to have difficulty in conducting this clinical trial<br>3. Patients who the doctor in charge deems inappropriate | COVID-19 | | To evaluate the change of aerosol particle number before, during, and after endoscopic examination with an Endo barrier | | 31/12/2021 | | No | False | | |
| → | CTRI/2020/03/024402 | 27 January 2021 | Hydroxy Chloroquine, in open labelled, Randomised intervention for prevention of new infection and adverse outcomes following COVID-19 infection -A Tertiary Hospital based study | Hydroxy Chloroquine, in open labelled, Randomised intervention for prevention of new infection and adverse outcomes following COVID-19 infection- A Tertiary Hospital based study - CORONA study | | Dr Remesh Bhasi | 31-03-2020 | 20200331 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42638 | Not Recruiting | No | | | | 08-04-2020 | 500 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 3 | India→ | Dr Remesh Bhasi→ | | Aster Malabar Institute of Medical Sciences (MIMS)
P O Govindapuram
Kozhikode
Kerala
India 673016 → | remesh.bhasi@asterhospital.com→ | 9447010634→ | Aster Malabar Institute of Medical Sceinces→ | Inclusion criteria: 1. Moderate to high risk of exposure to infected patients during the study period. <br/ ><br>2. Healthy at the time of enrolment without any symptoms suggestive of any viral infection.→ | Exclusion criteria: 1. History of known allergy to Hydro ChloroQuine(HCQ) or Chloroquine <br/ ><br>2. Known contraindications for HCQ or Chloroquine including Retinopathy, known Cardiac disease like Dysarrythmias, and G6PD deficiency. <br/ ><br>3. Pregnancy and Lactation <br/ ><br>4. History of recent (within one month) International travel. <br/ ><br>5. Features of any ongoing infection including COVID-19→ | | Intervention1: HCQS -MIMS Regimen: 300 mg daily x 1 wk followed by 300 mg weekly<br>Intervention2: Hydroxychloroquine: 300 mg daily x 7 days followed by 300 mg weekly x 7 weeks<br>Control Intervention1: Hydro Chloroquine(HCQ)-ICMR regimen: Group 2 : <br>400 mg bd for one day followed by 400 mg weekly for 7 weeks to be taken with meals (or until the epidemic stops) (ICMR Regimen)<br>Both groups will be advised to follow strict measures of self hygiene, social distancing and other routine protocols issued by IMA and Government bodies to prevent transmission. <br><br><br>→ | Infected Non infectedTimepoint: Time to clinical improvement→ | | | | Yes | False | | |
| → | CTRI/2020/04/024442 | 27 January 2021 | Screening for symptoms of COVID-19 | Max COVID Study | | Max Super Speciality Hospital A Unit of Devki Devi Foundation | 01-04-2020 | 20200401 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42687 | Not Recruiting | No | | | | 08-04-2020 | 5000 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | DrSujeet Jha→ | | Institute of Endocrinology, Diabetes and Metabolism, Max Super Speciality Hospital, 2, Press Enclave Road, Saket → | sujeet.jha@maxhealthcare.com→ | 9910609000→ | Max Healthcare (A Unit of Devki Devi Foundation)→ | Inclusion criteria: All male and female employees of Max Hospital and a wider population will be covered through an online questionnaire→ | Exclusion criteria: → | | | To identify suspected cases of COVID-19Timepoint: Weekly follow-up will be done→ | | | | Yes | False | | |
| → | CTRI/2020/04/024413 | 27 January 2021 | Knowledge, attitude and fear of COVID-19 in Bangladesh | Knowledge, attitudes, and fear of COVID-19 during the rapid rise period in Bangladesh | | K M Amran Hossain | 01-04-2020 | 20200401 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42718 | | No | | | | 09-04-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Bangladesh→ | Md. Shahoriar Ahmed→ | | Bangladesh Physiotherapy Association, CRP, Savar, Dhaka-1343 → | physiozahid@gmail.com→ | 8801670962775→ | Bangladesh Health Professions Institute→ | Inclusion criteria: 1) The willing Bangladeshi participants who responds to the questions. <br/ ><br>2)Students of Bangladesh Health professions Institute, their Family member, neighbor and friends. <br/ ><br>3)Staffs of Centre for the Rehabilitation of the paralysed, their family members, neighbors, friends.→ | Exclusion criteria: 1) Respondents with incomplete response to questionnaire <br/ ><br>2) Respondents with mental health or cognitive issue. <br/ ><br>3) Respondents those are unable to response to the questions.→ | | Intervention1: Not applicable: Not applicable<br>Control Intervention1: Not applicable: Not applicable<br>→ | Knowledge, attitude, practice, fear to COVID 19Timepoint: during answering the questionnaire→ | | | | Yes | False | | |
| → | CTRI/2020/04/024473 | 27 January 2021 | Viral Infection and Respiratory illness Universal Study | Viral Infection and Respiratory illness Universal Study:
COVID-19 Registry and Validation of C2D2 (Critical Care Data Dictionary) | | Discovery the Critical Care Research Network | 03-04-2020 | 20200403 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42684 | Not Recruiting | No | | | | 15-04-2020 | 50000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | United Kingdom;India;Italy;United States of America→ | Dr Naresh Kumar→ | | 125 BL Taneja Block
Department of Medicine
Maulana Azad Medical College
New Delhi → | drnareshmamc@gmail.com→ | 9953946064→ | Maulana Azad Medical College→ | Inclusion criteria: Inclusion Criteria: <br/ ><br>All patients with COVID-19 PCR positive (within 7 days)/PCR pending/high clinical suspicion admitted to VIRUS study participating hospital will be eligible. <br/ ><br>1. COVID-19 PCR positive (within 7 days) <br/ ><br>2. COVID-19 PCR pending <br/ ><br>3. COVID-19 high clinical suspicion→ | Exclusion criteria: Exclusion Criteria: <br/ ><br>1. Patient without Prior Research Authorization (applicable to Mayo Clinic sites) <br/ ><br>2. Non COVID-19 related admissions <br/ ><br>3. Repeated Admission to ICUs/Hospital→ | Health Condition 1: J128- Other viral pneumonia
→ | | To create a real time COVID-19 registry of current ICU/hospital care patterns to allow evaluations of safety and observational effectiveness of COVID-19 practices <br/ ><br> <br/ ><br>To determine the variations in practice across hospitals <br/ ><br>Hypothesis: The registry will be essential for near-real time observational comparative effectiveness studies to learn effective treatment strategies and/or provide meaningful hypotheses for clinical trialsTimepoint: 04/30/2021→ | | | | Yes | False | | |
| → | CTRI/2020/04/024482 | 27 January 2021 | A pan-india non-interventional virtual registry evaluating the prophylactic efficacy of different regimens against SARS-CoV2 infection (COVID-2019) in asymptomatic health care workers | A non-interventional registry evaluating the prophylactic efficacy of different regimens against SARS-CoV2 infection (COVID-2019) in asymptomatic health care workers - UNITY | | Zifo RnD Solutions | 07-04-2020 | 20200407 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42777 | Not Recruiting | No | | | | 07-04-2020 | 10000 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Arvind Sri Krishna Mani→ | | Zifo RnD Solutions
21A, Anna Salai, Little Mount, Saidapet → | vis.niranjan@rxmd.com→ | | Zifo RnD Solutions→ | Inclusion criteria: 1. Asymptomatic physicians of age â?¥ 21 years <br/ ><br>2. Physicians must be registered with Medical Council of India (MCI) or State Medical council (e.g. https://www.mciindia.org/CMS/information-desk/indian-medical-register%20for%20India) <br/ ><br>3. Physicians who think that by virtue of their profession, they are at risk for developing COVID 19 <br/ ><br>4. Physicians must be willing to provide data as required and willing to be contacted/ reminded about data entry at end of treatment and follow up <br/ ><br>5. Physicians must be willing to provide contact details of a designee, who may be contacted if the physician participant is not contactable→ | Exclusion criteria: Physicians who are not willing to participate in the study.→ | | Control Intervention1: NIL: NIL<br>→ | Efficacy of different prophylaxis regimens for prevention of COVID-19.Timepoint: The time point will be 7 and 9 weeks from the start of prophylaxis regimen.→ | | | | Yes | False | | |
| → | CTRI/2020/04/024479 | 27 January 2021 | Study of the effect of Hydroxychloroquine in addition to standard therapy in COVID-19 patients | Open labelled Randomised controlled trial to study the effect of Hydroxychloroquine in addition to standard therapy in COVID-19 patients | | COMMAND HOSPITAL AIRFORCE | 07-04-2020 | 20200407 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42713 | Not Recruiting | No | | | | 13-04-2020 | 32 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | SALIL GUPTA→ | | MEDICAL DIVISION
COMMAND HOSPITAL AIRFORCE
AGRAM POST → | chickusalil@yahoo.com→ | 8197751281→ | COMMAND HOSPITAL AIRFORCE→ | Inclusion criteria: a. Patients with oxygen saturation (SPO2) less than 95% <br/ ><br>b. Respiratory rate is more than 20/min <br/ ><br>c. Pulse rate more than 90/min <br/ ><br>d. Imaging evidence of lung infection in the form of Reticulonodular opacities, ground-glass opacities, consolidation and Acute Respiratory Distress Syndrome (ARDS) <br/ ><br>→ | Exclusion criteria: a. Asymptomatic patients <br/ ><br>b. Patients with mild illness (not satisfying inclusion criteria) <br/ ><br>c. Patients allergic to chloroquine <br/ ><br>d. Patients less than 14 years of age <br/ ><br>e. Patients unwilling for informed consent <br/ ><br>f. Pateints with prolonged QTc interval on ECG <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Hydroxychloroquine sulphate: Hydroxychloroquine sulphate tablets will be given in the dose of 400 mg twice on day 1 and then 400 mg once in a day for 04 days daily to the patients who meets the inclusion criteria<br>Control Intervention1: No drug: Hydroxychloroquine will not be given to control group. These patients will be managed as per standard protocol.<br>→ | number of days of hospitalizationTimepoint: discharge→ | | | | Yes | False | | |
| → | CTRI/2020/04/024636 | 27 January 2021 | Assessment of Objective clinical scoring system to rule out COVID-19 with high sensitivity | Outbreak of Respiratory Tract Infection Score (ORTIS): Objective Screening for Children to Rule Out COVID-19 and Prevent Nosocomial Spread - ORTIS | | DACH Jaipur | 15-04-2020 | 20200415 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42961 | Not Recruiting | No | | | | 01-05-2020 | 1000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Varnit Shanker→ | | Dr. Atuls Child Hospital
Shastri Nagar Road
Jaipur 302016 → | varnitshanker@gmail.com→ | | 1. DACH Jaipur 2. Harvard University, USA→ | Inclusion criteria: pediatric population presenting to OPD with complaints of headache, vomiting, loose stools, cold, cough, coryza, fever, pain abdomen, unrinary symptoms, refusal to feed and seizures.→ | Exclusion criteria: Following cases will be excluded from the study - chronic cases presenting for follow up, acutely ill presenting in the emergency, COVID-19 positive cases and immunocompromised patients.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 100% sensitivity in ruling out COVID-19 cases through ORTIS system.Timepoint: 100% sensitivity in ruling out COVID-19 cases through ORTIS system.→ | | | | Yes | False | | |
| → | CTRI/2020/04/024659 | 27 January 2021 | Study of Shreepad Shree Vallabh SSV Formulation to improve immunity in quarantine patients of COVID-19 | An open labelled trial to evaluate safety and efficacy of SSV Formulation to boost immunity in quarantine patients of COVID-19 | | SSV Phytopharmaceuticals | 15-04-2020 | 20200415 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42967 | Not Recruiting | No | | | | 27-04-2020 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Samadhan Patil→ | | Department of Medicine,
Niphad Sub district Hospital, Niphad, Maharashtra, India → | yogesh_dound@yahoo.com→ | 91-9769057549→ | Shreepad Shree Vallabh SSV Phytopharmaceuticals→ | Inclusion criteria: 1. Recent history of contact with COVID-19 positive people and are advised to be quarantined or has symptoms which include cough, fever with or without chills and difficulty in breathing. <br/ ><br>2. Willing to provide informed consent.→ | Exclusion criteria: 1. Presence of acute hypoxic respiratory failure. <br/ ><br>2. Intensive care unit (ICU) stay. <br/ ><br>3. Patients who need mechanical ventilation. <br/ ><br>4. Category 6 or 5 based on modified 7-category ordinal scale of clinical status.→ | Health Condition 1: B342- Coronavirus infection, unspecified
→ | Intervention1: SSV Formulation Tablets: Each tablet of 500 mg to be consumed orally twice a day immediately after meals for 15 days.<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | Improvement in ambulatory patients who are assessed daily for symptoms which include cough, fever with or without chills and difficulty in breathing for the period they are in quarantine. <br/ ><br> <br/ ><br>Timepoint: Baseline, telephonically everyday and day 15.→ | | 28/05/2020 | | Yes | False | | |
| → | CTRI/2020/04/024706 | 27 January 2021 | Effect of convalescent plasma in COVID-19 patients | Efficacy of Convalescent Plasma Therapy in Severely Sick COVID-19 Patients: A Pilot Randomized Controlled Trial. | | Institute of Liver and Biliary Sciences | 17-04-2020 | 20200417 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43039 | Not Recruiting | No | | | | 21-04-2020 | 40 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 2 | India→ | Dr Meenu Bajpai→ | | D-1, Vasant Kunj
New Delhi-110070 → | meenubajpai@hotmail.com→ | 01146300000→ | Institute of Liver and Biliary Sciences→ | Inclusion criteria: Recipient: <br/ ><br>Severe COVID -19 infections defined as WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria- <br/ ><br>1. Respiratory distress, RR â?¥30 beats/min <br/ ><br>2. Oxygen saturation level less than 93% in resting state <br/ ><br>3. Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) â?¤ 300 mmHg. <br/ ><br>4. Lung infiltrates > 50% within 24 to 48 hours <br/ ><br>5. Very sick (on ventilator) and patients with co-morbidities such as patients with known co- <br/ ><br> morbid diseases (COPD, CAD, CLD, CKD, cardiopulmonary disease-structural or valvular heart <br/ ><br> disease) <br/ ><br>6. Patient presenting with multi organ failure or requiring mechanical ventilation. <br/ ><br>7. Minimum age: 18 yrs to maximum age- no limit as per recent protocol amendment. <br/ ><br> <br/ ><br>Donor: <br/ ><br>â?¢ Known case of recovered COVID-19 Infection, and <br/ ><br>â?¢ Complete resolution of symptoms at least 28 days prior to donation or <br/ ><br>Complete resolution of symptoms at least 14 days prior to donation and negative results for COVID-19 either from one or more nasopharyngeal swab specimens or by a molecular diagnostic test from the blood, <br/ ><br> And <br/ ><br>Negative RT-PCR for COVID-19 on two sequential paired nasopharyngeal and throat specimens > 24 hrs apart (WHO-CDC guideline). <br/ ><br>â?¢ Donor Plasma after 2 negative tests and 2 weeks of remaining asymptomatic, without antibody titre & presence of IgG/IgM antibodies to COVID-19 by serological as per manufacturers instructions. Donors negative for these will be deferred). <br/ ><br>â?¢ Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs & Cosmetics Act and Rules 1945, amended 11.03.2020.→ | Exclusion criteria: Recipient <br/ ><br>â?¢ Patients with age less than 18 years. <br/ ><br>â?¢ Pregnancy <br/ ><br>â?¢ Individual with HIV and Hepatitis <br/ ><br>â?¢ Morbid Obesity BMI >35 kg/m2 <br/ ><br>â?¢ Extremely moribund patients with an expected life expectancy of less than <br/ ><br> 24 hours. <br/ ><br>â?¢ Failure to give informed consent from the patient or family members. <br/ ><br>â?¢ Hemodynamic instability requiring vasopressors. <br/ ><br>â?¢ Previous allergic history to plasma. <br/ ><br> <br/ ><br>Donor: <br/ ><br>â?¢ Donors age < 18 and â?¥60 years old <br/ ><br>â?¢ Do not fulfil all criteria of donor eligibility for donor Plasmapheresis under <br/ ><br> the Drugs & Cosmetics Act and Rules 1945, amended 11.03.2020. <br/ ><br>â?¢ Females who have been pregnant and previously transfused donors (to <br/ ><br> prevent TRALI). <br/ ><br>â?¢ Donors who have taken steroids during treatment for COVID-19.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Convalescent Plasma with Supportive Care: 200-600 mL convalescent plasma,single dose or into divided doses,intravenous for 1 to 7 days along with supportive care<br>Control Intervention1: Random donor Plasma with Supportive Care: 200-600 mL random donor plasma,single dose or into divided doses,intravenous for 1 to 7 days along with supportive care. Supportive Care will be based on symptomatic treatment<br>→ | Proportion of patients remaining free of mechanical ventilation in both groupsTimepoint: day 7→ | | 30/05/2020 | | Yes | False | | |
| → | CTRI/2020/04/024697 | 27 January 2021 | COVID-19 Data-bank Project | Formulation of a Clinical databank by retrospective consolidation of Indian COVID-19 patient data. | | CARING MAHAJAN IMAGING | 17-04-2020 | 20200417 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42835 | Not Recruiting | No | | | | 17-04-2020 | 100000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | VIdur Mahajan→ | | Defence colony Defence colony→ | vidur@mahajanimaging.com→ | | CARING, Mahajan Imaging→ | Inclusion criteria: Cases of COVID-19 (SARS-CoV-2 infection) proven by laboratory tests→ | Exclusion criteria: NA→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | A single source of patient-level clinical data for researchers to access so that clinical and analytics tools can be created to fight COVID-19 during the epidemic phase in India.Timepoint: NA→ | | | | Yes | False | | |
| → | CTRI/2020/04/024731 | 27 January 2021 | Study to Evaluate Preventive Effect of Ayurveda and Homeopathy Treatment in COVID 19 | Evaluation of Effect of Composite AYUSH Treatment as Prophylaxis of COVID 19 | | Superintendent | 20-04-2020 | 20200420 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42912 | Not Recruiting | No | | | | 24-04-2020 | 50 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | Dr Harish Daga→ | | Parul Institute of Ayurved, Parul University,
AP Limda, Tal Waghodia, → | dr.shaileshd@gmail.com→ | 9763104451→ | Parul Institute of Ayurved→ | Inclusion criteria: Subjects who are not suffering from active illness due to infecction at the time of inclusion→ | Exclusion criteria: 1.Subjects suffering from active illness due to infection at the time of inclusion. <br/ ><br>2.Subjects suffering from uncontrolled DM, HTN etc. <br/ ><br>3. Subjects who are known cases of immune-compromised or autoimmune condition such as HIV. <br/ ><br>4.Pregnant and lactating women→ | | Intervention1: Samshamani Vati (500 mg twice daily after food with warm water for 15 days), Sudarshan Ghana Vati (250 mg thrice daily after food with warm water for 15 days), Khadiradi Vati (250 mg twice daily for chewing for 15 days), Murrchhita Tila Taila (for Nasya (nasal instillation) 2 drops in each nostril in morning and evening for 15 days), Aesenic Album 30 (4 tablets before lunch for 3 days): For 15 days<br>Intervention2: Sudarshan Ghana Vati: 250 mg thrice daily after food with warm water for 15 days<br>Intervention3: Khadiradi Vati: 250 mg twice daily for chewing for 15 days<br>Intervention4: Murrchhita Tila Taila: for Nasya (nasal instillation) 2 drops in each nostril in morning and evening for 15 days<br>Intervention5: Aesenic Album 30: 4 tablets before lunch for 3 days<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | Episodes and severity of symptoms of respiratory tract infection (cold, sore throat, dry cough, breathlessness) in subjects who may get direct or indirect exposure to COVID 19 during lockdown in March and April 2020Timepoint: From Baseline till the end of 15 days→ | | | | Yes | False | | |
| → | CTRI/2020/04/024729 | 27 January 2021 | Topical Chloroquine Nasal Drops in Early Stage Covid 19-
Impact on Viral load and cure rates
| Topical Chloroquine Nasal Drops in Early Stage Covid 19-
Impact on Viral load and cure rates
| | All India Institute of Medical Sciences New Delhi | 20-04-2020 | 20200420 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42933 | Not Recruiting | No | | | | 21-04-2020 | 60 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2 | India→ | Alok Thakar→ | | Department of Otolaryngology and Head and Neck Surgery,
Teaching Block 4th Floor, AIIMS,
Ansari Nagar East,
New Delhi → | drathakar@gmail.com→ | | AIIMS, New Delhi→ | Inclusion criteria: Adult patients testing positive on the RT-PCR Covid-19 test with minimal symptoms and no hypoxemia.→ | Exclusion criteria: Age <18 years <br/ ><br>b) Pregnancy and lactation <br/ ><br>c) Known hypersensitivity to chloroquine <br/ ><br>d) known case of G6PD deficiency, Long QT syndrome and retinopathy <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: Topical Nasal 0.03% chloroquine eye drops: To receive 0.03% Chloroquine drops 1ml â?? 6 times daily X 10 days. <br> + all treatments & observations recommended by the treatment team<br><br>Control Intervention1: Standard Treatment: Control Arm - all treatments & observations recommended by the treatment team<br> No nasal drops<br><br>→ | 1) The Ct values on Day 0, 3, 7, 10 shall be plotted on a graph for all patients. <br/ ><br>2) The rate of decline for each patient shall be calculated. <br/ ><br>The time to cure (Covid 19 RT PCR -ve.) shall be determined <br/ ><br>3) The two groups shall be compared for <br/ ><br>a. Rate of decline of Ct values <br/ ><br>b. Time to Cure <br/ ><br>c. Rate of Cure or alternate outcome <br/ ><br>Timepoint: 1) The Ct values on Day 0, 3, 7, 10 shall be plotted on a graph for all patients. <br/ ><br>2) The rate of decline for each patient shall be calculated. <br/ ><br>The time to cure (Covid 19 RT PCR -ve.) shall be determined <br/ ><br>3) The two groups shall be compared for <br/ ><br>a. Rate of decline of Ct values <br/ ><br>b. Time to Cure <br/ ><br>c. Rate of Cure or alternate outcome <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/04/024772 | 27 January 2021 | Comparison of suspected or negative cases with confirmed cases of COVID-19 at Max Hospital | A prospective, longitudinal, observational study to assess the seroconversion status of front line Health Care workers and comparison with the suspected or confirmed cases of COVID-19 patients at Max Health Careâ?? (Project D) | | Max Healthcare A Unit of Devki Devi Foundation | 21-04-2020 | 20200421 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43079 | Not Recruiting | No | | | | 28-04-2020 | 90 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Samreen Siddiqui→ | | Max Super Speciality Hospital, 2, Press Enclave Road → | sujeet.jha@maxhealthcare.com→ | 09910609000→ | Max Healthcare Institute Ltd.→ | Inclusion criteria: â?¢Healthcare workers of Max Hospital, irrespective of age and gender OR <br/ ><br>â?¢COVID-19 positive patients admitted in the hospital OR <br/ ><br>â?¢Out-patients getting tested for COVID-19 <br/ ><br>→ | Exclusion criteria: â?¢Refusal to give informed consent, or contraindication to venipuncture.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Seropositivity in the collected samplesTimepoint: 6 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/04/024747 | 27 January 2021 | EFFECTIVENESS TO MANAGE COVID 19 PANDEMIC BY TEACHING VENTILATORY MANAGEMENT TO NON-ANAESTHESIOLOGY RESIDENTS | EFFECTIVENESS OF SIMULATION BASED TEACHING OF VENTILATORY MANAGEMENT AMONG NON-ANAESTHESIOLOGY RESIDENTS TO MANAGE COVID 19 PANDEMIC. | | GSL MEDICAL COLLEGE | 21-04-2020 | 20200421 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43115 | Not Recruiting | No | | | | 01-05-2020 | 26 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | TATIKONDA CHANDRA MOULI→ | | DEPT OF ANAESTHESIOLOGY
GSL MEDICAL COLLEGE
RAJAHMUNDRY → | chandradasavatar@gmail.com→ | 9591654666→ | GSL MEDICAL COLLEGE→ | Inclusion criteria: RESIDENTS OF DEPARTMENTS OF GENERAL SURGERY, ORTHOPEDICS, DERMATOLOGY, OPHTHALMOLOGY→ | Exclusion criteria: RESIDENTS OF ANAESTHESIOLOGY→ | | Intervention1: To teach ventilatory management in COVID19 patients: <br><br><br>classes will be conducted using HPS (human patient simualator ) and 3classes one on arterial blood gases ,one on basics of mechanical ventilation ,and finally mechanical ventilation in covid patients.A debriefing session will be carried out after every scenario, which will start with the trainee describing what happened during the scenario. This will be followed by analytical phase in which the trainee will be asked the successful aspects of the scenario and the factors that could have been improved. In the last phase of debriefing session, participants will be asked to reflect upon their training.<br>A pre & post evaluation (Total 20 questions each carries 1 mark) will be conducted to assess the effectiveness of the in teaching module. The scores will be compared by wilcoxon sign rank test. <br>Skill based assessment will be conducted by DOPS method. <br>Feedback will be taken from the participants in a five point likertâ??s scale at the end of the teaching learning session.<br><br>→ | 1. To prepare a module for non anesthesiology trainees to handle ventilators in management of COVID 19 patients.Timepoint: 1. To prepare a module for non anesthesiology trainees to handle ventilators in management of COVID 19 patients. <br/ ><br>→ | | 01/05/2020 | | Yes | False | | |
| → | CTRI/2020/04/024775 | 27 January 2021 | Study to assess the efficacy and safety of convalescent plasma in moderate COVID-19 disease. | A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications in Moderate Disease. - PLACID | | Indian Council Of Medical Research | 21-04-2020 | 20200421 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43149 | Not Recruiting | No | | | | 22-04-2020 | 452 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Anup Agarwal→ | | Ansari Nagar, New Delhi → | mailanupagarwal@gmail.com→ | 8582932607→ | Indian Council of Medical Research→ | Inclusion criteria: 1. Patients admitted with RT-PCR confirmed COVID-19 illness. <br/ ><br>2. Age > 18 years <br/ ><br>3. Has any of the two <br/ ><br>a. PaO2/ FiO2: 200-300 <br/ ><br>b. Respiratory Rate > 24/min and SaO2 < 93% on room air <br/ ><br>4. Availability of matched donor plasma at the point of enrolment <br/ ><br>→ | Exclusion criteria: 1. Pregnant women <br/ ><br>2. Breastfeeding women <br/ ><br>3. Known hypersensitivity to blood products <br/ ><br>4. Receipt of pooled immunoglobulin in last 30 days <br/ ><br>5. Critically ill patients: <br/ ><br>a. P/F ratio <200 (moderate - severe ARDS) <br/ ><br>b. Shock <br/ ><br>6. Participating in any other clinical trial <br/ ><br>7. Clinical status precluding infusion of blood products <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Convalescent plasma: Convalescent plasma, 2 doses of 200 mL each, from recovered COVID-19 patient.<br>Control Intervention1: Usual care for COVID-19 disease: Usual care for COVID-19 disease<br>→ | The primary outcome is a composite measure of the avoidance of - <br/ ><br>1. Progression to severe ARDS (P/F ratio 100) or <br/ ><br>2. All-cause Mortality at 28 days <br/ ><br>Timepoint: 28 days from intervention <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/04/024773 | 27 January 2021 | A clinical trial to study the effects of additional treatments for patients hospitalized and receiving treatment due to COVID -19. | An international randomised trial of additional treatments for COVID-19 in
hospitalised patients who are all receiving the local standard of care - SOLIDARITY TRIAL | | World Health Organization | 21-04-2020 | 20200421 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42897 | Recruiting | No | | | | 01-05-2020 | 7000 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3 | Argentina;Brazil;Canada;Germany;India;Indonesia;Iran (Islamic Republic of);Norway;Peru;Qatar;South Africa;Spain;Switzerland;Thailand→ | DrSheela Virendra Godbole→ | | ICMR-National AIDS Research Institute, Pune
G 73 BLOCK MIDC BHOSARI PUNE
→ | sgodbole@nariindia.org→ | 09422087972→ | ICMR-National AIDS Research Institute, Pune→ | Inclusion criteria: 1. Adults (aged â?¥18 years) hospitalized with definite COVID-19 <br/ ><br>2. Not already receiving any of the study drugs <br/ ><br>3. Without known allergy or contraindications to any of them (in the view of the physician responsible for their care) <br/ ><br>4. Without anticipated transfer within 72 h to a non-study hospital <br/ ><br> <br/ ><br>Patients invited to join the study will be those who are admitted to a collaborating hospital; no wider recruitment efforts are expected→ | Exclusion criteria: 1. Any of the available study drugs are contra-indicated (e.g. because of patient characteristics, chronic liver or heart disease, or some concurrent medication) <br/ ><br>2. Pregnant <br/ ><br>3. Declined to participate in the study <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Remdesivir: local standard of care plus Remdesivir (daily infusion for 10 days) <br><br>Intervention2: chloroquine or hydroxychloroquine: local standard of care plus chloroquine or hydroxychloroquine (two oral loading doses, then orally twice daily for 10 days)<br>Intervention3: Lopinavir with Ritonavir (orally twice daily for 14 days): Local standard of Care plus Lopinavir with Ritonavir (orally twice daily for 14 days)<br>Intervention4: Lopinavir with Ritonavir (ditto) plus Interferon: Local standard of care plus Lopinavir with Ritonavir ((orally twice daily for 14 days) plus Interferon (daily injection for 6 days).<br>Control Intervention1: Local standard of care: Local standard of care<br>→ | All-cause mortality, subdivided by the severity of disease at the time of randomization, measured using patient records throughout the studyTimepoint: Throughout the study→ | | | | Yes | False | | |
| → | CTRI/2020/04/024749 | 27 January 2021 | Study to Evaluate the Efficacy of Recombinant BCG VPM1002 in Reducing Infection Incidence and Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Subjects | A Multicenter, Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy of Recombinant BCG VPM1002 in Reducing Infection Incidence and Disease Severity of SARS-COV-2/COVID-19 Among High-Risk Subjects | | Serum Institute of India Pvt Ltd | 21-04-2020 | 20200421 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42972 | Not Recruiting | No | | | | 21-04-2020 | 5946 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3 | India→ | Dr Umesh Shaligram→ | | Serum Institute Of India Pvt. Ltd. 212/2, Hadapsar, Pune India
Pune → | drhjs@seruminstitute.com→ | 02026602451→ | Serum Institute Of India Pvt. Ltd.→ | Inclusion criteria: 1. Male or Female subjects â?¥ 18 years of age at high-risk of SARS-CoV-2/COVID-19 infection <br/ ><br>2. Test negative for SARS-CoV-2 infection (RT-PCR test) at screening <br/ ><br>3. Capable of giving informed consent→ | Exclusion criteria: 1. Previous history of Tuberculosis or known active Mycobacterium tuberculosis infection <br/ ><br>2. Received BCG vaccine within one year prior to screening <br/ ><br>3. Fever (greater than or equal to 38 ºC/100.4°F) or any other respiratory symptoms/illnesses within the past 14 days <br/ ><br>4. Pregnant or lactating women <br/ ><br>5. Women of child-bearing potential not agreeing to use adequate contraception <br/ ><br>6. Current active viral or bacterial infection <br/ ><br>7. Expected vaccination during the study period, independently of the type of vaccination <br/ ><br>8. Severely immunocompromised subjects. <br/ ><br>9. Active solid or non-solid malignancy or lymphoma within the prior two years <br/ ><br>10. Individuals known to be hypersensitive to any component of the vaccine <br/ ><br>11. Eczema or other significant skin lesion or infection at the site/s of injection. <br/ ><br>12. Any other medical condition which in the opinion of the investigator may affect the subjectâ??s safety or study participation and conduct <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: Z23- Encounter for immunization
→ | Intervention1: recombinant BCG vaccine, VPM1002: Dose : 0.1 ml, single dose of the reconstituted vaccine to be administered as an intradermal injection<br>Control Intervention1: Placebo, 0.9% sodium chloride: Dose : 0.1 ml, single dose to be administered as an intradermal injection<br>→ | 1.Number of subjects with laboratory confirmed COVID-19 infection among HCWs <br/ ><br>2.Number of subjects with laboratory confirmed COVID-19 infection among other high-risk subjects <br/ ><br>3.Number of laboratory confirmed COVID-19 infection with severe, critical or life-threatening disease as assessed by Investigator among HCWs <br/ ><br>4.Number of laboratory confirmed COVID-19 infection with severe, critical or life-threatening disease as assessed by Investigator among other high-risk subjectsTimepoint: up to 6 months (180 days) following vaccine administration→ | | | | Yes | False | | |
| → | CTRI/2020/04/024806 | 27 January 2021 | Imatinib in COVID-19 infection | Efficacy of Imatinib in mild SARS CoV2 infection: A randomized study | | All India Institute of Medical Sciences | 22-04-2020 | 20200422 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42843 | Recruiting | No | | | | 26-04-2020 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2 | India→ | Akash Kumar→ | | Department of Medical Oncology,
2nd Floor, BRAIRCH,
All India Institute Of Medical Sciences,
Ansari Nagar, New Delhi → | akashjha08@yahoo.com→ | | All India Institute of Medical Sciences→ | Inclusion criteria: a) Age -18 years and above (no upper age limit ) <br/ ><br>b) Mildly symptomatic Patients admitted in the AIIMS hospital with a proven diagnosis of COVID 19 infection on RT-PCR, with National Early Warning Score (NEWS score) â?¤3 <br/ ><br>→ | Exclusion criteria: a) Abnormal Liver function at baseline, i.e. Serum Bilirubin > 1.5 ULN, ALT and AST > 3 ULN. Upto 5 times in case of chronic liver disease. <br/ ><br>b) Abnormal renal functions at baseline, i.e.. Serum creatinine > 1.5 ULN <br/ ><br>c) Prior history of exposure to imatinib <br/ ><br>d) Any other condition assessed by physiciansâ?? team that will lead to difficulty in carrying out the trial. <br/ ><br>e) Pregnant or breast feeding women. <br/ ><br>f) Patients unable to swallow oral medicines. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Imatinib - Oral Drug: Imatinib- 600mg per oral once daily<br>(D1-D14)<br>Control Intervention1: supportive care: supportive care<br>→ | 1. Proportion of patients with negative viral titre in the intervention arm in comparison with those in standard arm on D-7 <br/ ><br>2. Proportion of patients with negative viral titre in the intervention arm in comparison with those in standard arm on D-14Timepoint: d-7 & d-14→ | | | | Yes | False | | |
| → | CTRI/2020/04/024804 | 27 January 2021 | Evaluation of safety and efficacy of convalescent plasma in COVID-19 patients | Open Label, parallel arm, phase I/II clinical trial to evaluate Safety and efficacy of Convalescent Plasma as Therapy for Covid-19 Severe SARS-CoV-2 Disease | | International Stemcell Services Ltd | 22-04-2020 | 20200422 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42849 | Recruiting | No | | | | 11-05-2020 | 24 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 1/ Phase 2 | India→ | Meena Dalal→ | | 681, 17th Cross Road, JP Nagar 6th Phase, KR Layout, Bengaluru, Karnataka- 560078 → | jyotrao@gmail.com→ | 9620252285→ | International Stemcell Services Ltd→ | Inclusion criteria: - 18 years and older (male or female) <br/ ><br>- Laboratory confirmation of COVID â?? 19 <br/ ><br>- CT image is characteristic of 2019 novel corona virus pneumonia (optional) <br/ ><br>- Sign a consent form and follow the test plan and follow-up process. <br/ ><br> <br/ ><br>Inclusion criteria for donors of plasma <br/ ><br>- 18 years and older (male or female) <br/ ><br>- Patients who have recovered from COVID-19 and who have been discharged from COVID -19 treatment centres or units could be potential donors for CP, from 28 days after their day of discharge. <br/ ><br>- COVID patients who have been discharged according to the WHO criteria as: 1) clinically asymptomatic and 2) twice tested negative for SARS-CoV-2 by molecular techniques, should be considered as potential donors. The two samples for SARS-CoV-2 testing should be taken at least 48 hours apart, and the test results should be negative on each sample. <br/ ><br>- The donors selected for donation should be RNA negative for COVID and for the transfusion transmissible infections (HIV 1/2, HBV, HCV, malaria and syphilis). <br/ ><br>- Sign a consent form and follow the test plan and follow-up process. <br/ ><br> <br/ ><br>→ | Exclusion criteria: - Patients with autoimmune disease in the past or screening <br/ ><br>- Those who have serious disease that affect their overall survival as decided by the treating clinican <br/ ><br>- Self reports HIV or syphilis infected persons <br/ ><br>- Pregnant or lactating women <br/ ><br>- Continuous use of immunosuppressive agents or organ transplants in the past 6 months. <br/ ><br> <br/ ><br>Exclusion criteria for donors <br/ ><br>- Patients who become sick again after getting discharged <br/ ><br>- RNA positive for COVID or TTI positive. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: convalescent plasma: Arm A Subjects will be administered about 500 ml of apheresis derived Convalescent plasma intravenously in a single dose along with standard care of therapy<br>Control Intervention1: standard care of therapy: In Arm B the standard care will be as per the local hospital protocol and as per recommendations/guidelines by the respective authorities (Ministry of Health and Family Welfare, CDC and USFDA) whichever fits best at the time of initiation of this study. This will also be followed by the best supportive care guidelines recommended by the authorities (Ministry of Health and Family Welfare, CDC and USFDA).<br>→ | Safety, efficacy. <br/ ><br>Side effects measured by Chest Radiograph. <br/ ><br>Improvement of clinical symptoms including duration of fever, respiratory distress, pneumonia, cough, sneezing, and diarrhea within 3 days of the convalescent plasma transfusion. <br/ ><br>Oxygen Saturation, Pao2/Fio2. <br/ ><br>Decrease in viral load as detected by PCR, serum antibody titer. <br/ ><br>Routine blood biochemical parameters including renal and liver function tests. <br/ ><br>Sequential Organ Failure Assessment (SOFA)Timepoint: Viral load (RT-PCR)- Day -2, Day 1, Day 3, Day 7, Day 14 <br/ ><br>Eg. CT chest- Day -2, Day 3, Day 7 and Day 14 <br/ ><br>Pao2/Fio2 and Sequential Organ Failure assessment (SOFA)- Day 0, Day 1, Day 3, Day 7 and Day 14 <br/ ><br>Remaining parameters will be checked on Day 0, Day 1, Day 3, Day 7, Day 14 and Day 28→ | | | | Yes | False | | |
| → | CTRI/2020/04/024776 | 27 January 2021 | Novel Artificial Intelligence Algorithm to screen COVID-19 Patients from X-Ray , CT-Scan of Thorax and Voice Sampling through Android App and storage through Cloud | Novel Artificial Intelligence Algorithm to screen COVID-19 patients from X-Ray and CT-Scan of Thorax and Voice Sampling through Android App and storage through Cloud | | Dr Mahesh Mahich | 22-04-2020 | 20200422 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43160 | Recruiting | No | | | | 23-04-2020 | 1650 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Mahesh Mahich→ | | Room no. 11, Dept. of Chest and TB, R.N.T. Medical College , Badi, Udaipur → | dr.mahich@gmail.com→ | 9829185697→ | Rabindra Nath Tagore Medical College, Udaipur→ | Inclusion criteria: Patients who are COVID -19 +ve , Pneumonia confirmed and normal willing persons.→ | Exclusion criteria: Those subjects who fails to give consent.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Chest X-Ray Artificial Intelligence Module: Chest X-Ray in 3 arms :-<br>1. COVID - 19 + ve patients<br>2. Pneumonia patients<br>3. X- Rays of no respiratory illness patients<br>Intervention2: CT - Scan of THORAX Artificial Intelligence Module: CT - Scan Thorax in 3 Arms -<br>1. COVID-19 +ve patients <br>2. Pneumonia patients <br>3. Normal willing population<br>Intervention3: Voice Sampling Artificial Intelligence Module: Voice Sampling through Android App and storage through Cloud in 3 arms -<br>1. COVID-19 patients<br>2. Pneumonia patients<br>3. Normal willing population<br>Control Intervention1: Normal subjects Chest X-Ray , CT-Scan Thorax and Voice sampling: Normal and willing subjects Chest X-Ray, CT-Scan and Voice sampling through android app and storage in cloud<br>→ | To asess sensitivity and specificity of screening based on Artificial Intelligence module by performing Chest X-Ray, CT -Thorax and Voice Sampling in COVID +VE patients.Timepoint: 8 Weeks - Data collection <br/ ><br>10 Weeks - Validation through Artificial Intelligence Modules→ | | | | Yes | False | | |
| → | CTRI/2020/04/024784 | 27 January 2021 | ANXIETY AND DEPRESSION DURING COVID-19 IN INDIA | PREVALENCE OF SYMPTOMS OF ANXIETY AND DEPRESSION DURING COVID-19 IN INDIA: A WEB-BASED CROSS-SECTIONAL STUDY
| | Dr Sameer Malhotra SELF SPONSORED NO CONFLICT OF INTEREST | 22-04-2020 | 20200422 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42939 | Not Recruiting | No | | | | 24-04-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shreya Singhal→ | | 1, 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi 1, 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi→ | singhal.shreya21@gmail.com→ | 9810022980→ | Max Super Speciality Hospital, Saket, New Delhi→ | Inclusion criteria: Participants of the age of 18 years and above <br/ ><br>Participants residing in India <br/ ><br>Participants with minimum 10 years of education with basic knowledge of English <br/ ><br>→ | Exclusion criteria: Participants under the age of 18 years <br/ ><br>Participants residing outside of India <br/ ><br>Participants with previous history of any major psychiatric illness, psychiatric hospitalization or currently on any psychiatric medication. <br/ ><br>→ | | | To understand the prevalence (magnitude) of depression and anxiety of general adult population during COVID-19 using Generalized Anxiety Disorder Scale (GAD-7) and Patient Health Questionnaire (PHQ-9). Rise in Anxiety and Depression will be noted. <br/ ><br>Timepoint: 1 month during the period of COVID-19 pandemic. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/04/024805 | 27 January 2021 | Impact of Covid-19 pandemic on practice pattern of Indian urologists | Impact of Covid-19 on practice patterns of Indian urologists | | Department of Urology | 22-04-2020 | 20200422 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42979 | Not Recruiting | No | | | | 24-04-2020 | 160 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sanjoy Kumar Sureka→ | | Department of Urology, SGPGIMS, Rae Bareli Road, Lucknow - 226014, Uttar Pradesh → | drsksureka@gmail.com→ | 9792679779→ | SGPGIMS→ | Inclusion criteria: Practising Indian urologist→ | Exclusion criteria: Non-urologists <br/ ><br>Urologists practising outside India→ | | | Reduction in outpatients after Covid outbreak <br/ ><br>Reduction in surgeries after Covid outbreakTimepoint: % Reduction in outpatients after Covid outbreak <br/ ><br>% Reduction in surgeries after Covid outbreak→ | | | | Yes | False | | |
| → | CTRI/2020/04/024833 | 27 January 2021 | BCG-Denmark versus no-BCG for COVID 19 prevention | Effect of BCG-Denmark (Green Signal) on prevention of COVID 19 infection in health care workers â?? a double blind randomized controlled trial | | Dr Narayanan Parameswaran | 24-04-2020 | 20200424 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43105 | Not Recruiting | No | | | | 01-05-2020 | 1826 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | N/A | India→ | Narayanan Parameswaran→ | | Department of Paediatrics, Women and Children Hospital,JIPMER,
Dhanvantari Nagar P.O. Dhanvantari Nagar, Puducherry→ | narayanan.p@jipmer.edu.in→ | 9443458850→ | JIPMER, Puducherry→ | Inclusion criteria: 1. All HCWs (doctors and nurses and housekeeping staff) posted to take care of patients in the designated COVID 19 wards / ICUs for at least one shift (minimum 6 hours). <br/ ><br>2. All HCWs (doctors and nurses and housekeeping staff) likely to be posted in Emergency medical services (EMS) for one week (minimum 56 hours). <br/ ><br>3. All laboratory workers likely to be posted for at least one week in a Virology laboratory where SARS-CoV-2 testing is being performed. <br/ ><br>→ | Exclusion criteria: 1.HCWs not directly involved in patient care (facility manager, supervisory staff not physically present in the patient care areas) <br/ ><br>2. A immunodeficiency state (including primary immunodeficiency, HIV infection, chemotherapy or high-dose steroid therapy (more than or equal to 20 mg for more than or equal to 2 weeks),non-biological immunosuppressant (also known as DMARDS), biological agents (such as monoclonal antibodies against tumor necrosis factor (TNF)-alpha) <br/ ><br>3. Pregnancy <br/ ><br>4.Malignancy <br/ ><br>5.Active skin disease such as eczema, dermatitis or psoriasis at or near the site of vaccination. <br/ ><br>6.Previously had a SARS-CoV-2 positive test result <br/ ><br>7.BCG vaccine received in the past one year <br/ ><br>→ | | Intervention1: BCG-Denmark (Green Signal): BCG-Denmark (Green Signal), 0.1 ml, intradermal injection in left deltoid area<br>Control Intervention1: Placebo: Normal saline, 0.1 ml administered intradermally in the deltoid area of left arm<br>→ | Proportion of HCW with symptomatic COVID 19 disease 6 months after randomization. Symptomatic COVID 19 will be defined as self-reported fever or cough, or shortness of breath, or respiratory distress, or runny or blocked nose plus a positive PCR test and/or antibody testTimepoint: Six months after randomisation→ | | | | Yes | False | | |
| → | CTRI/2020/04/024846 | 27 January 2021 | A Clinical Trial of Mycobacterium w in Critically Ill COVID 19 Patients | A clinical trial to evaluate the safety and efficacy of Mycobacterium W in critically ill patients suffering from COVID 19 infection | | Cadila Pharmaceuticals Limited | 24-04-2020 | 20200424 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43004 | Recruiting | No | | | | 30-04-2020 | 300 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 3 | India→ | Dr Anil Avhad→ | | 1389, Trasad Road
Dholka, Ahmedabad 1389, Trasad Road
Dholka, Ahmedabad→ | anil.avhad@cadilapharma.co.in→ | | Cadila Pharmaceuticals Limited→ | Inclusion criteria: 1. Critically ill COVID-19 patients who have been tested positive by RT-PCR for SARS-CoV-2 on the nasopharyngeal or throat swabs. <br/ ><br>2. Patient aged 18 years or more of either gender <br/ ><br>3. Illness of any duration with respiratory rate â?¥25 breaths/minute, and at least one of the following: <br/ ><br>- SpO2 â?¤90% on room air, or <br/ ><br>- Requiring mechanical ventilation and/or supplemental oxygen <br/ ><br>4. Female patients of childbearing potential must have a negative pregnancy test within 14 days prior to first dose of study medication. <br/ ><br>5. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedure.→ | Exclusion criteria: 1. Pregnant or nursing female. <br/ ><br>2. Patients with history of allergy, hypersensitivity, or any serious reaction to study medication <br/ ><br>3. Patients with a concomitant medical condition, whose participation, in the opinion of the investigator, may create an unacceptable additional risk. <br/ ><br>4. Patient previously enrolled into this study. <br/ ><br>5. Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukemia or HIV. <br/ ><br>6. Patients with a life expectancy judged to be less than five days <br/ ><br>7. ALT/AST > 5 times the upper limit of normal <br/ ><br>8. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) <br/ ><br>9. Patients not likely to complete the trial as per judgment of the investigator.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J00-J99- Diseases of the respiratory system
→ | Intervention1: Suspension of heat killed (autoclaved)Mycobacterium w: 0.3 ml (0.1 ml x 3 Inj.) of Mw intra-dermal for 3 consecutive days with Standard therapy of COVID-19<br>Control Intervention1: Placebo: 0.3 ml (0.1 ml x 3 Inj.) of Placebo intra-dermal for 3 consecutive days with Standard therapy of COVID-19<br>→ | 1. To evaluate the efficacy of Mw by measuring the improvement in Ordinal scale. <br/ ><br> <br/ ><br>2. To evaluate 28-day mortality.Timepoint: 1. From baseline to day 3, 7, 14, 21 and 28 and day of transfer from ICU, if earlier than 28 days. <br/ ><br> <br/ ><br>2.Till day 28, post-randomization or death or discharge, whichever is earlier.→ | | | | Yes | False | | |
| → | CTRI/2020/04/024857 | 27 January 2021 | Proving the efficacy of Homeopathic treatment in prevention and cure of COVID-19. | Proving the efficacy of Homeopathic treatment in prevention and cure of COVID-19. | | Welling Healthcare Private Limited | 25-04-2020 | 20200425 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43212 | Not Recruiting | No | | | | 04-05-2020 | 100 | Interventional | Cluster Randomized Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Open Label | Phase 1/ Phase 2 | India→ | DrSourabh R Welling→ | | Welling Clinic, 2nd Floor, Gokul Arcade, Opp Garware, Sahar Road,Andheri East, Mumbai Mumbai→ | drwelling@welling.co.in→ | 9768068440→ | Welling Homeopathy Clinics→ | Inclusion criteria: Initial stage of cough and breathlessness and asymptomatic.→ | Exclusion criteria: Patients who have already reached stage where they need ventilator or other life support.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Homeopathy Medicines - Ars Alb, Camphora, Bryonia Alba, Helleborus niger, Justicia Adhatoda.: Oral Route<br>In 30c, 1M and 3x potency.<br>Twice a day till relief from symptoms or tests are negative.<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | Lesser percentage of admissions to critical care.Timepoint: At 4 weeks and 8 weeks.→ | | | | Yes | False | | |
| → | CTRI/2020/04/024859 | 27 January 2021 | To Study the Clinical characteristics and treatment Outcome of COVID-19 Patients admitted in hospitals of Max Healthcare (SCOPe Study) | To Study the Clinical characteristics and treatment Outcome of COVID-19 Patients admitted in hospitals of Max Healthcare (SCOPe Study) - SCOPe | | Max Super Speciality Hospital A Unit of Devki Devi Foundation | 25-04-2020 | 20200425 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43232 | Not Recruiting | No | | | | 25-04-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Rajesh Saxena→ | | Max Super Speciality Hospital (DDF), East Block, Service Floor, 2- Press Enclave Road, New Delhi → | docmishra@yahoo.co.in→ | | Internal Medicine, Max Super Speciality Hospital (DDF), Saket→ | Inclusion criteria: â?¢ Patients of either sex aged â?¥18 years <br/ ><br>â?¢ Patients who are Covid-19 positive <br/ ><br>â?¢ All patients with positive Corona virus infection admitted in the hospitals of Max Healthcare will be included in the study. <br/ ><br>→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | To study clinical profile and outcome of hospitalized COVID-19 patients.Timepoint: Till discharge or death of subject→ | | | | Yes | False | | |
| → | CTRI/2020/04/024858 | 27 January 2021 | â??To study the effectiveness of Ivermectin with standard of care treatment
versus standard of care treatment for COVID 19 cases. A Pilot Study | â??To study the effectiveness of Ivermectin with standard of care treatment
versus standard of care treatment for COVID 19 cases. A Pilot Study | | Max Super Speciality Hospital A Unit of Devki Devi Foundation | 25-04-2020 | 20200425 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43236 | Not Recruiting | No | | | | 25-04-2020 | 50 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment: Blinding and masking:Open Label | N/A | India→ | Rajesh Saxena→ | | Max Super Speciality Hospital (DDF), East Block, Service Floor, 2- Press Enclave Road, New Delhi → | docmishra@yahoo.co.in→ | 9810193145→ | Internal Medicine, Max Super Speciality Hospital (DDF), Saket→ | Inclusion criteria: 1. Subjects within age group between 18 to 75 years <br/ ><br>2. With either sex, male or female <br/ ><br>3. Confirmed case of COVID-19 at Max Hospitals.→ | Exclusion criteria: Patients who are critically sick→ | Health Condition 1: B338- Other specified viral diseases
→ | Intervention1: Ivermectin: Cases of COVID 19 shall be<br>treated with Ivermectin 200 to 400mcg per kg body weight on day 1 and day 2 along with<br>standard treatment of the hospital protocol<br>Control Intervention1: Standard treatment as per hospital protocol for COVID 19: Cases of<br>COVID 19 shall be treated with standard treatment as per hospital protocol for COVID 19 until the recovery.<br>→ | This study aims to confirm the antivirus effectiveness of Ivermectin on coronavirus i.e COVID 19 <br/ ><br>then to explore its potential use in the combating to the COVID 19 pandemics.Timepoint: Viral load will be monitored at 1, 3 & 5 days from beginning of trial drug (48 hours interval) Until the report comes negative. Drug will be delivered on daily basis upto eradication of virus or completion of <br/ ><br>the trial→ | | | | Yes | False | | |
| → | CTRI/2020/04/024882 | 27 January 2021 | A study to assess the effectiveness of Ayurvedic formulation in addition to standard of care in COVID-19 positive patients in a tertiary hospital. | Effect of an Ayurvedic Formulation as add-on to standard of care in COVID-19 positive patients in a tertiary hospital | | Ministry of AYUSH Government of India | 27-04-2020 | 20200427 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42899 | Not Recruiting | No | | | | 28-04-2020 | 60 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Mr.Kuldeep K Chauhan→ | | 10th Floor,Medanta The Medicity,Sector-38,Gurgaon,Haryana → | drsushilakataria@gmail.com→ | | | Inclusion criteria: Age > 18 years <br/ ><br>Written Informed consent is documented <br/ ><br>COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test. <br/ ><br>Can take oral medicines <br/ ><br>Mild-moderate grade of the disease <br/ ><br> <br/ ><br>Subject may be discontinued from the study if confirmatory test results are available subsequently and are negative for COVID 19 infection.→ | Exclusion criteria: Known sensitivity to any of the ingredients <br/ ><br>Bleeding haemorrhoids <br/ ><br>Serious stages of the illnesses <br/ ><br>ICU admitted patients <br/ ><br>Pre-existing GI symptoms like nausea or vomiting→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Kashaya(Decoction): 90-100 ml of kashaya of Tinospora cordifolia stem added with 2gms of finelly powdered dried Piperlongum fruit,once in the morning before breakfast and once in the evening before dinner as add on therapy in addition to standard of care medicines<br>Control Intervention1: Standard of Care: Patients on Standard care medicines who do not agree to take the ayurvedic medicine.<br>→ | Percentage of patients progressing to serious/critical stage of disease <br/ ><br>Progress of disease as per clinical severity score (COCSS) <br/ ><br>No. of days of treatment, hospitalisation, type of care and site of treatment at hospital, oxygen support requirement, days of ventilation required, period of convalescence and return to normal life activity <br/ ><br>No. of days taken to test negative for COVID, total days to discharge frm hospital <br/ ><br>Profiling acc to tridosha <br/ ><br>Defining the disease according to AyurvedaTimepoint: Observed and recorded on all days of the treatment as relevant <br/ ><br>Recorded on the days when the investigation is done <br/ ><br>Recorded on the days when the medication is changed in type or dose <br/ ><br>Recorded as average of pO2 in a day <br/ ><br>Recorded as volume of O2 supplied etc→ | | | | Yes | False | | |
| → | CTRI/2020/04/024904 | 27 January 2021 | Treatment of COVID19 : A randomised controlled trial | Randomised Controlled Trial to compare efficacy of hydroxychloroquine alone and in combination with azithromycin in treatment of COVID-19
- HAZES | | Director General Armed Forces Medical Services | 28-04-2020 | 20200428 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43130 | Not Recruiting | No | | | | 11-05-2020 | 300 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Outcome Assessor Blinded | Phase 3 | India→ | Col Anurag Khera→ | | Field Hospital → | vksashindran@gmail.com→ | 919958826493→ | Armed Forces Medical Services→ | Inclusion criteria: Age > 18 years <br/ ><br>All sexes <br/ ><br>Case definitions for inclusion in the study will include mild, moderately severe and severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVI19 issued by Ministry of Health and Family Welfare, Govt of India on 07 Apr 2020. <br/ ><br> Mild: Cases presenting with fever and/or upper respiratory tract illness (Influenza like Illness, ILI) <br/ ><br> Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%). <br/ ><br> Severe: Severe Pneumonia (with respiratory rate â?¥30/minute and/or SpO2 < 90% in room air) or ARDS or septic shock <br/ ><br> <br/ ><br>Laboratory confirmed SARS CoV-2 infection within last 10d or SARS CoV-2 test result pending with a high clinical suspicion as defined by: <br/ ><br>Cough of <10d duration <br/ ><br>Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air <br/ ><br>No alternative explanation for respiratory symptoms <br/ ><br>Scheduled for admission or enrolled within 48h of hospital admission <br/ ><br>→ | Exclusion criteria: Children < 18 years <br/ ><br>Pregnant or lactating women <br/ ><br>Symptoms of acute respiratory tract infection for > 10d before randomisation <br/ ><br>More than 48h have elapsed between meeting inclusion criteria and randomisation <br/ ><br>Seizure disorder <br/ ><br>Known case of G6PD deficiency <br/ ><br>Diagnosed long QT syndrome <br/ ><br>QTc >500ms on ECG within 72h prior to enrolment <br/ ><br>Chronic haemodialysis or GFR <20 ml/min <br/ ><br>Psoriasis or porphyria cutanea tarda <br/ ><br>Severe liver disease <br/ ><br>Any subject who has received the following drugs in the 12h period before enrolment or who is likely to receive the following during the period of therapy with HCQ / HCQ + AZT / AZT: amiodarone, cimetidine, phenobarbitone, phenytoin, digoxin <br/ ><br>Receipt of >1 dose of HCQ / AZT in 10 days prior to enrolment <br/ ><br>Known allergic reactions to HCQ or azithromycin <br/ ><br>Inability to take/receive enteral medication <br/ ><br>Inability to be contacted on D14 for clinical outcome assessment (unless died in hospital)→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: Hydroxychloroquine sulfate (HCQs): HCQ 400mg BD on D1 and 400 mg OD on D2 - 5<br><br>Intervention2: Hydroxychloroquine sulphate high dose HCQh): HCQ 600 mg BD on D1 and 600 mg OD on D2 - 5<br><br>Intervention3: HCQ high dose (HCQh): HCQ 600mg BD D1<br>HCQ 300mg BD D2 - D5<br>Control Intervention1: HCQ AZT: HCQ 400mg BD AZT 500mg OD D1<br>HCQ 400mg OD AZT 250 mg OD D2 - D5<br>→ | COVID Ordinal Outcomes Scale is defined as: <br/ ><br>1. Death <br/ ><br>2. Hospitalised on invasive mechanical ventilation or extracorporeal mechanical ventilation ( ECMO) <br/ ><br>3. Hospitalised on non-invasive ventilation or high-flow nasal cannula oxygen therapy <br/ ><br>4. Hospitalised on supplemental oxygen <br/ ><br>5. Hospitalised not on supplemental oxygen <br/ ><br>6. Not hospitalised with limitation of activity (due to continued symptoms) <br/ ><br>7. Not hospitalised without limitation in activity (no symptoms)Timepoint: D14 <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/04/024883 | 27 January 2021 | Clinical research on safety and efficacy of ZingiVir-H as an add on therapy in COVID-19 patients. | Randomized controlled Single blinded prospective multi centre clinical trial to
investigate the safety and efficacy of ZingiVir-H as an adjuvant therapy in hospitalized adults
diagnosed with coronavirus disease 2019 (COVID-19) | | Pankajakasthuri herbal research foundation | 28-04-2020 | 20200428 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43168 | Not Recruiting | No | | | | 29-04-2020 | 112 | Interventional | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:An Open list of random numbers Blinding and masking:Outcome Assessor Blinded | Phase 4 | India→ | DrJHareendran Nair→ | | Pankajakasthuri Herbal research Foundation Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum Pankajakasthuri Ayurveda Medical college Kattakkada Trivandrum→ | drshan@pkhil.com→ | 9188325339→ | Pankajakasthuri Herbal research Foundation→ | Inclusion criteria: 1. Patients of both sexes aged from 18 years to 60 years old. <br/ ><br>Willing and able to provide written informed consent prior to performing study <br/ ><br>procedures by the subject or legal guardian willing and able to provide written informed <br/ ><br>consent prior to performing study procedures <br/ ><br>3. Patients with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection <br/ ><br>confirmed by RT Polymerase chain reaction (RT-PCR) test between 1 and 120 Hours <br/ ><br>before randomization <br/ ><br>4. Currently hospitalized and requiring medical care for COVID-19 <br/ ><br>5. Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening <br/ ><br>6. Radiographic evidence of pulmonary infiltrates→ | Exclusion criteria: Candidates for the study will be excluded if ANY of the following criteria are present: <br/ ><br>1. Subject or Authorized Representative is unable to provide informed consent <br/ ><br>2. Subject is pregnant or breastfeeding ladies <br/ ><br>3. Subject is of childbearing potential and has a positive pregnancy test since admission to <br/ ><br>the hospital <br/ ><br>4. Subject is < 18 years of age <br/ ><br>5. Subject has a known allergy to herbal compounds or ZingiVir-H or any components of <br/ ><br>the drug product <br/ ><br>6. Subject has had previous treatment with ZingiVir-H <br/ ><br>7. Body weight â?¥ 175 kg <br/ ><br>8. Intra-thoracic or intra-abdominal surgery within the 12 hours prior to consent, or ongoing <br/ ><br>impairment of hemostasis as a result of one of these procedures <br/ ><br>9. A history of head trauma, spinal trauma, or other acute trauma with an increased risk of <br/ ><br>bleeding. <br/ ><br>10. Cerebral Vascular Accident (CVA) or Intracerebral Arteriovenous Malformation (AVM), <br/ ><br>cerebral aneurysm, or mass lesions of the central nervous system or melena, <br/ ><br>hematemesis. <br/ ><br>11. Inability to take oral medication <br/ ><br>12. Prolonged QTc-interval in baseline ECG ( >500 ms) <br/ ><br>13. History of solid organ, allogeneic bone marrow, or stem cell transplantation. <br/ ><br>14. Severe renal failure characterized by chronic or acute need of hemodialysis, <br/ ><br>hemofiltration or peritoneal dialysis <br/ ><br>15. Need of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics during the <br/ ><br>treatment period. <br/ ><br>16. Participation in another research study involving an investigational agent within 30 days prior to consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ZingiVir H: It is a poly herbomineral drug.Therapeutic dose: <br>ONE tablet (500 mg) each consumed once in 3 hours ±1 hour between 6 AM and 9 PM in a given day (6AM, 9AM, 12Noon, 3PM, 6PM, 9PM) for a minimum duration of 10 days to Maximum 15 days as per the clinical conditions and disease outcome.<br>Control Intervention1: not applicable: not applicable<br>→ | The Odds of Ratio for Improvement on a 7-point Ordinal Scale on Day 15 [Time Frame: Day 15 from the day of study inclusion]. The odds ratio represents the odds of improvement in the ordinal scale between the treatment groups. The ordinal scale is an assessment of the clinical status at a given day. Each day, the worst score from the previous day will be recorded. <br/ ><br>Timepoint: Baseline ,Day 7 and Day 15→ | | 24/08/2020 | | Yes | False | | |
| → | CTRI/2020/04/024914 | 27 January 2021 | Characteristics of seriously ill COVID-19 patients admitted to a tertiary care centre | Epidemiology and clinical characteristics of COVID- 19 patients requiring critical care in a tertiary care teaching hospital | | Dr Sulagna Bhattacharjee | 29-04-2020 | 20200429 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43323 | Not Recruiting | No | | | | 08-05-2020 | 60 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sulagna Bhattacharjee→ | | 96, Gautam Nagar, 2nd floor, Shanti Kutir, New Delhi Room no 5011, 5th floor, Teaching block, AIIMS, New Delhi-110029→ | bhattacharjee.sulagna85@gmail.com→ | 09818212531→ | AIIMS, New Delhi→ | Inclusion criteria: Patients fulfilling WHO case definition of COVID-19 and admitted in an ICU at AIIMS, New Delhi.→ | Exclusion criteria: Patients or relatives who refused to provide consent or have unproven or suspected COVID- 19 infection will be excluded from this study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
Health Condition 3: J128- Other viral pneumonia
→ | | To assess ICU mortality in COVID-19 patients admitted to the intensive care unit of AIIMS, New DelhiTimepoint: Till ICU stay/ or upto 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/04/024915 | 27 January 2021 | A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications | A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma to Limit COVID-19 Associated Complications | | Max Super Speciality Hospital A Unit of Devki Devi Foundation | 29-04-2020 | 20200429 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43332 | Not Recruiting | No | | | | 09-05-2020 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 2 | India→ | Rajesh Saxena→ | | Max Super Speciality Hospital (Devki Devi Foundation), East Block, Service Floor, 2, Press enclave Road, Saket New Delhi → | sangeeta.pathak@maxhealthcare.com→ | 9873081647→ | Blood Bank, Max Super Speciality hospital, Saket (A unit of Devki Devi Foundation)→ | Inclusion criteria: 1. Patients admitted with RT-PCR confirmed COVID-19 illness. <br/ ><br>2. Age > 18 years <br/ ><br>3. Written informed consent <br/ ><br>4. Has any of the two <br/ ><br>a. PaO2/ FiO2 <300 <br/ ><br>b. Respiratory Rate > 24/min and SaO2 < 93% on room air→ | Exclusion criteria: 1. Pregnant women <br/ ><br>2. Breastfeeding women <br/ ><br>3. Known hypersensitivity to blood products <br/ ><br>4. Receipt of Pooled Immunoglobulin in last 30 days <br/ ><br>6. Participating in any other clinical trial <br/ ><br>7. Clinical status precluding infusion of blood products→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Convalescent Plasma: 200 ml of ABO compatible plasma transfusion will be done to the subject randomized for the therapy<br>Control Intervention1: Standard care of treatment: control group will be treated as per Standard care of treatment. The Ministry of Health and Welfare has issued detailed guidelines for the management of sCOVID-19 based on varying grades of severity. For the management of ARDS or sepsis, the respective guidelines issued by ARDSNet and Surviving Sepsis campaign will be followed. Other institutional protocols for supportive management will be implemented.<br>→ | The primary outcome is a composite measure of the avoidance of - <br/ ><br>1. Progression to severe ARDS (P/F ratio 100) and <br/ ><br>2. All-cause Mortality at 28 daysTimepoint: one year→ | | | | Yes | False | | |
| → | CTRI/2020/04/024948 | 27 January 2021 | A clinical Trial to Study the Effects of Hydroxychloroquine, Ciclesonide and Ivermectin in treatment of moderate COVID-19 illness | EFFICACY OF HYDROXYCHLOROQUINE, CICLESONIDE AND IVERMECTIN IN TREATMENT OF MODERATE COVID-19 ILLNESS: AN OPEN-LABEL RANDOMISED CONTROLLED STUDY - EHYCIVER-COVID | | Lady Hardinge Medical College | 30-04-2020 | 20200430 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43364 | Not Recruiting | No | | | | 15-05-2020 | 120 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Anupam Prakash→ | | Department of Medicine
Lady Hardinge Medical College
Shahid Bhagat Singh Marg
New Delhi
110001
INDIA → | prakashanupam@hotmail.com→ | 8588885305→ | LADY HARDINGE MEDICAL COLLEGE→ | Inclusion criteria: â?¢ Adult patients (â?¥18years) suffering from Covid-19. A positive throat swab (by real time PCR) obtained from a patient suspected to be Covid-19 or from a contact (or HCW) of Covid-19 patient will be considered to be a Covid-19 case. <br/ ><br>â?¢ Presence of moderate Covid-19 disease (10) as defined by presence of pneumonia (clinical and radiological signs) with respiratory rate between 15 to 30/minute and/or SpO2 90%-94% on room air. <br/ ><br>→ | Exclusion criteria: â?¢ Patients with renal or hepatic dysfunction (Serum creatinine > 1.5 mg/dL and serum transaminase levels >120 U/L) <br/ ><br>â?¢ Patients with clinical heart failure/known CAD <br/ ><br>â?¢ Known cases of neoplasms or immunodeficiency syndromes <br/ ><br>â?¢ Patients who are on chemotherapy, immunosuppressive agents, steroids or antiviral agents, or have received in the preceding 4 weeks <br/ ><br>â?¢ Pregnant and lactating patients <br/ ><br>â?¢ Uncooperative patients (in the opinion of the investigator, if it is difficult to ensure patient cooperation during the study) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: Hydroxychloroquine: 400 mg bid Day1 followed by 200 mg bid on Days 2 to 7<br>Intervention2: Ciclesonide: 200 mcg bid for 7 days<br>Intervention3: Ivermectin: 12 mg OD for 7 days<br>Control Intervention1: Standard of Care: Supportive management as per national guidelines<br>→ | Proportion of patients having virologic cure on Day 6 in each of the groupsTimepoint: Day 6 of treatment initiation→ | | | | Yes | False | | |
| → | CTRI/2020/04/024949 | 27 January 2021 | A study to evaluate the effect of Oral Niclosamide in mild and very mild COVID-19 cases | EFFICACY OF ORAL NICLOSAMIDE IN TREATMENT OF MILD AND VERY MILD COVID-19 CASES: AN OPEN-LABEL RANDOMIZED CONTROLLED TRIAL - EONIC-COVID | | Lady Hardinge Medical College | 30-04-2020 | 20200430 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43400 | Recruiting | No | | | | 15-05-2020 | 48 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Anupam Prakash→ | | DEPARTMENT OF MEDICINE,
SHAHEED BHAGAT SINGH MARG,
NEW DELHI-110001 → | prakashanupam@hotmail.com→ | 8588885305→ | LADY HARDINGE MEDICAL COLLEGE→ | Inclusion criteria: â?¢ Adult patients (â?¥18years) suffering from mild or very mild Covid-19 (8). A positive throat swab for nCoV-2019 (by real time PCR) obtained from a patient suspected to be Covid-19 or from a contact (or HCW) of Covid-19 patient will be considered to be a Covid-19 case, irrespective of the presence of symptoms. Mild disease will be defined as respiratory rate between 12-18/minute and SpO2 â?¥ 95% in room air and no clinico-radiological (normal chest X-ray) signs of pneumonia.→ | Exclusion criteria: â?¢ Patients with renal or hepatic dysfunction (Serum creatinine > 1.5 mg/dL and serum transaminase levels >120 U/L) <br/ ><br>â?¢ Patients with clinical heart failure/known CAD <br/ ><br>â?¢ Known cases of neoplasms or immunodeficiency syndromes <br/ ><br>â?¢ Patients who are on chemotherapy, immunosuppressive agents, steroids or antiviral agents, or have received in the preceding 4 weeks <br/ ><br>â?¢ Pregnant and lactating patients <br/ ><br>â?¢ Uncooperative patients (in the opinion of the investigator, if it is difficult to ensure patient cooperation during the study) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: Niclosamide: 500 mg bid for 7-14 days<br>Control Intervention1: Standard of care: As per MoHFW, GoI guidelines<br>→ | Proportion of patients having virologic cure on Day 6 in both the groupsTimepoint: Day 6 of treatment initiation→ | | | | Yes | False | | |
| → | CTRI/2020/04/024947 | 27 January 2021 | Clinical trial on effects of homeopathic medicine made from cadamba on COVID-19 | Drug Proving & checking its effectiveness in treatment of COVID 19 | | Dr Priti katre | 30-04-2020 | 20200430 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43259 | Not Recruiting | No | | | | 08-05-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Not Applicable | Phase 3 | India→ | Prashant katre→ | | dr katre house
homoeo clinic civil line homoeo clinic civil line→ | priti.katre@gmail.com→ | 9325259285→ | Homoeo clinic→ | Inclusion criteria: 1 COVID affected individual (serologically positive) symptomatic, mild hospitalized <br/ ><br>2 asymptomatic (serologically positive)→ | Exclusion criteria: 1.Malabsorption or inadequate oral intake <br/ ><br>2.unexplained, chronic diarrhea, defined as more than 3 loose stool per day persisting for 2 weeks or more within the month prior to study entry. <br/ ><br>3. Active malignancy or anticipated need for chemotherapy during the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: cadamba drug therapy: 1st 3 days 6 doses in every 2 hours <br>QID 3 days <br>then TDS for weeks <br>potency 200<br><br>→ | with refrance to time scale T1-T4 -- <br/ ><br>from 5-7 weeks we expect complete recovery of patient who presented with initial symptoms. <br/ ><br>1 patient should be asymptomatic with gental recovery (with serologically negative blood test) within 7-14 days after administration of 1st dose of medicine. <br/ ><br>2 asymptomatic patient (serologically positive) will remain asymptomatic and should be serologically negative after 7-14 days of treatment.Timepoint: with refrance to time scale T1-T4 -- <br/ ><br>from 5-8 weeks we expect complete recovery of patient who presented with initial symptoms.→ | | | | Yes | False | | |
| → | CTRI/2020/05/024967 | 27 January 2021 | Herbal product Clinical trial on COVID-19 patients | A Prospective, Open label, Randomized-controlled study to evaluate the efficacy and safety of MyVir tablets in mildly symptomatic COVID- 19 patients | | MiLab LifeSciences P Ltd | 01-05-2020 | 20200501 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43338 | Not Recruiting | No | | | | 11-05-2020 | 42 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Post Marketing Surveillance | India→ | MrLAKSHMANA PERUMAL SPT→ | | Mi Lab LifeSciences(P) Limited 81 & 82, Shree Om Ramaswamy
Reddy Layout, Horamavu, Bengaluru, Karnataka
Bangalore
KARNATAKA → | lakshman@milablifesciences.com→ | 8050717400→ | Mi Lab LifeSciences(P) Limited→ | Inclusion criteria: 1. Subjects age group 18 - 65 years both gender <br/ ><br>2. Patients diagnosed with COVID-19 positive mild symptomatic patients (Confirmed by RTPCR) - Patients with uncomplicated upper respiratory infection <br/ ><br>a. Spo2 >94% in room air <br/ ><br>b. Respiratory rate <24 per min <br/ ><br>c. No evidence of hypoxaemia or breathlessness <br/ ><br>3. Subjects willing to give a written informed consent and come for a regular follow up <br/ ><br>4. Subject willing to abide by and comply with the study protocol <br/ ><br>→ | Exclusion criteria: i.Presence of acute hypoxic respiratory failure. <br/ ><br>ii.Intensive care unit (ICU) stay. <br/ ><br>iii. Patients who need mechanical ventilation. <br/ ><br>iv.Category 6 or 5 based on modified 7-category ordinal scale of clinical status. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: MyVir tablets: Dosage Form: Tablet <br>Duration : Day 1 to Day 21 <br>Route : Orally twice daily after meal<br>Control Intervention1: Standard treatment as per hospital protocol for COVID 19: Cases of COVID 19 shall be treated with standard treatment as per hospital protocol for COVID 19 until the recovery<br><br>Day 1 to Day 21 Route : Orally twice daily after meal As per the Hospital guidelines.<br>Route : Orally<br>Dose: As per standard Hospital policy<br>→ | 1.RT PCR on Day 0,Day 7 and Day 10 <br/ ><br>2.LDH, TLC, CRP, D-DIMER and RT PCR from baseline to end of the study i.e. 14 days <br/ ><br>Timepoint: Day 1,Day 7,Day 10 and Day 14→ | | | | Yes | False | | |
| → | CTRI/2020/05/024959 | 27 January 2021 | Efficacy and Safety of Itolizumab in COVID-19 Complications | A Multi-Centre, Open label, Two Arm Randomized, Pivotal Phase 2 Trial to Study the Efficacy and Safety of Itolizumab in COVID-19 Complications | | Biocon Biologics India Limited | 01-05-2020 | 20200501 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42878 | Not Recruiting | No | | | | 01-05-2020 | 30 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Sivakumar Vaidyanathan→ | | Biocon Biologic India Limited Biocon House Semicon Park Electronics City Phase 2
Bangalore 560100 Karnataka India
→ | subramanian.l101@biocon.com→ | 08028085305→ | Biocon Biologic India Limited→ | Inclusion criteria: 1. Male or female adults above 18 years (not tested in children yet) <br/ ><br>2. Informed consent for participation in the study <br/ ><br>3. Virological diagnosis of SARS-CoV2 infection (PCR) <br/ ><br>4. Hospitalized due to clinical/instrumental diagnosis of COVID-19 infection <br/ ><br>5. Oxygen saturation at rest in ambient air â?¤94% <br/ ><br>6. Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of < 200 or <br/ ><br>more than 25% detoriation from the immediate previous value. <br/ ><br>→ | Exclusion criteria: 1. Known severe allergic reactions to monoclonal antibodies <br/ ><br>2. Active tuberculosis (TB) infection <br/ ><br>3. History of inadequately treated tuberculosis or latent tuberculosis <br/ ><br>4. In the opinion of the investigator,progression to death is highly probable, irrespective of the provision of treatments <br/ ><br>5. Have received oral anti-rejection or immune-suppressive drugs within the past 6 months <br/ ><br>6. Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor) <br/ ><br>7. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination <br/ ><br>8. Patients with known history of Hepatitis B, Hepatitis C or HIV <br/ ><br>9. Absolute Neutrophils count (ANC) <1000 / mm3 <br/ ><br>10. Platelets <50,000 / mm3 <br/ ><br>11. Absolute Lymphocyte count (ALC): <500/mm3 <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J70- Respiratory conditions due to other external agents
→ | Intervention1: Arm A Best supportive care with Itolizumab: Start at 1.6 mg/kg dose iv infusion, if well tolerated and improvement in patient observed, investigator has the discretion to continue with 1.6 mg/kg dose every 2 weeks or 0.8 mg/kg weekly regimen.<br>Control Intervention1: Arm B Best supportive care: By best supportive careâ?? which includes antivirals /antibiotics/ hydroxychloroquine; oxygen therapy, will be administered. The best supportive care will be as per institution standard<br>→ | 1 one month mortality rate <br/ ><br>2 Proportion of pts with deterioration of lung function as measured by <br/ ><br>â?¢ Stable SpO2; PaO2 without increasing FiO2 <br/ ><br>3 Reduction of endotracheal intubation rate, measured as rate of pts needing intubation <br/ ><br>4 Reduction in proportion of pts who need <br/ ><br>â?¢ NIV <br/ ><br>â?¢ IMV <br/ ><br>â?¢ HFNO <br/ ><br>5 Time of duration of mechanical ventilation, for pts needing intubation <br/ ><br>6 Change in inflammatory markers CRP, d-Dimer, ferritin <br/ ><br> <br/ ><br>Timepoint: up to One-month <br/ ><br>→ | | 07/07/2020 | | Yes | False | | |
| → | CTRI/2020/05/024969 | 27 January 2021 | Homoeopathy as adjuvant in management of Covid-19 infection | Effect of adjuvant homoeopathy with standard treatment protocol in management of covid-19: a randomised, open label, placebo controlled, parallel group study
| | Naiminath Homoeopathic Medical College Hospital and Research Centre | 01-05-2020 | 20200501 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43393 | Not Recruiting | No | | | | 15-10-2020 | 100 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Anil Khurana→ | | 61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058→ | drdnayak@gmail.com→ | 09873404012→ | CCRH→ | Inclusion criteria: o Symptomatic RT-PCR confirmed cases of <br/ ><br> Covid-19 infection. <br/ ><br>o Both sexes <br/ ><br>o Age between 18 years to 80 years and <br/ ><br>o Willing to give signed written informed <br/ ><br> consent <br/ ><br>→ | Exclusion criteria: 1. Patients requiring ventilatory support <br/ ><br>2. Patients with compromised immunity <br/ ><br>3. Severe heart, lung, kidney, brain, blood <br/ ><br> diseases or other important systemic <br/ ><br> diseases <br/ ><br>4. Subjects unable to complete the study, or <br/ ><br> not suitable for the study by <br/ ><br> researchers. <br/ ><br>5. Women during pregnancy <br/ ><br>6. Lactating mothers <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Homoeopathic medicine: Homoeopathic medicines will be given to this group patients as an add-on to standard treatmet. Following Individualization medicines will be selected keeping in view pathological aspect of disease. Dose and potency will be according to the frequency, intensity and duration of signs and symptoms. Repetitions will vary from cae to case basis cosidering disease state and vitality of patient. Range of potency from 30, 200, 1M etc will be used.<br>Control Intervention1: Placebo: Placebo group patients will receive identical placebo (globules moistened with dispensing alcohol) as an add on to standard protocol treatment. Dose repetition will be a in similar pattern to medicine group.<br>→ | Clinical outcome in terms of recovery of patient or requirement of life support (ventilator)/ death.Timepoint: Ever 24 hr.→ | | | | Yes | False | | |
| → | CTRI/2020/05/024962 | 27 January 2021 | The use of topical Povidone Iodine (PVP-I) oropharyngeal and intranasal application during the current coronavirus pandemic as a potential measure to reduce viral transmission | Effectiveness of topical povidone iodine (PVP-I) oropharyngeal and intranasal application during the current coronavirus pandemic amongst COVID-19 positive patients in Andhra Pradesh, India | | WIN MEDICARE PVTLTD | 01-05-2020 | 20200501 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43237 | Not Recruiting | No | | | | 05-05-2020 | 96 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Centralized Blinding and masking:Not Applicable | N/A | India→ | Dr Sumita Shankar→ | | Department of Plastic Surgery
Pithampuram, Road, Kakinada, Andhra Pradesh → | sum713@yahoo.com→ | 9848184495→ | Rangaraya Medical College→ | Inclusion criteria: All patients laboratory tested COVID-19 positive above 18 years of age +/- two days of admission→ | Exclusion criteria: Known allergy to povidone iodine or iodine <br/ ><br>thyroid disorders <br/ ><br>pregnancy <br/ ><br>patients on Lithium therapy <br/ ><br>patients on respiratory distress / unconscious / on ventilator→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Povidone Iodine: 2% Povidone Iodine gargle diluted to 1% (w/v) is used as oropharyngeal gargle and intranasal application given 4 times to 48 laboratory tested COVID-19 patients and followed up for 12 weeks<br>Control Intervention1: normal saline: 48 patients laboratory tested COVID-19 positive selected and tested on 7th and 21st day for comparison and followed for 12 weeks to check for any relapse<br>→ | comparing the reduction in the progression, transmission of disease in 48 participants taking oropharyngeal gargles and intranasal application of PVP-I in comparison to the control group not doing the same for which patients in both the group will be tested for viral load on 7 th and 21 st day. Spread of the disease can be checked by confirming if the nasal / oropharyngeryngel swabs turn negative and no contacts turn covid-19 positiveTimepoint: The study group will be tested for covid-19 to check for negativity on & 7th and 21st day following intervention→ | | | | Yes | False | | |
| → | CTRI/2020/05/024981 | 27 January 2021 | Clinical study on Dabur Chyawanprash as a preventive remedy in pandemic of Covid-19. | â??Clinical evaluation of Dabur Chyawanprash (DCP) as a preventive remedy in pandemic of COVID-19 â?? An Open label, Multi centric, Randomized, Comparative, Prospective, Interventional Community based Clinical Study on Healthy individuals.â?? - NIL | | Dabur India Ltd | 02-05-2020 | 20200502 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43374 | Not Recruiting | No | | | | 15-05-2020 | 600 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Sanjay Tamoli→ | | A wing, 402-A/B/C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai
→ | targetinstitute@yahoo.com→ | 9322522252→ | Target Institute of Medical Education and Research→ | Inclusion criteria: Subjects meeting all of the following criteria will be included in the trial- <br/ ><br>1. Healthy, Male or Female subjects between the age group of 5 years to 70 years (both inclusive). Healthy individuals will be considered as those who do not have any acute medical condition or chronic medical/surgical condition that requires either immediate or continuous medical monitoring and treatment. <br/ ><br>2. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study. <br/ ><br>→ | Exclusion criteria: 1.Pregnant and Lactating females <br/ ><br>2. Subjects who have been confirmed of having COVID-19 and have been isolated for its treatment. Subjects having recently suffered and recovered of COVID-19 will also be excluded from the study <br/ ><br>3. Known cases of Diabetes <br/ ><br>4. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. <br/ ><br>5. Subjects taking steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study. <br/ ><br>7. Subjects having a past history of allergy to Chyawanprash like products <br/ ><br>8. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol <br/ ><br>→ | | Intervention1: Dabur Chyawanprash: Dosage and Treatment Duration: <br>Adults (13 -70 years): One teaspoonful (approx. 12 gm of Chyawanprash) twice daily followed by milk<br>Children (5-12 years): Half teaspoonful (approx. 6 gm of Chyawanprash) twice daily followed by milk<br><br>Control Intervention1: Milk with Turmeric powder: 200 ml milk with turmeric powder twice daily<br>Control Intervention2: Milk: One cup of milk (approx 200 ml) twice daily<br>→ | 1.Comparative assessment of incidence of COVID-19 in subjects taking DCP and those not taking it over a period of 3 months (90 days) <br/ ><br>2. Comparative assessment of incidence of other non COVID-19 infections in subjects taking DCP and those not taking it over a period of 3 months (90 days) <br/ ><br>Timepoint: Day 15,30, 45, 60, 75, 90→ | | 15/10/2020 | | Yes | False | | |
| → | CTRI/2020/05/024982 | 27 January 2021 | Effects of using hydroxychloroquine and azithromycin in the treatment of confirmed COVID-19 positive patients | USAGE OF HYDROXYCHLOROQUINE AND AZITHROMYCIN IN INDICATED CONFIRMED COVID-19 POSITIVE CASES FOR ITS EFFICACY IN EARLY NEGATIVE CONVERSION- PILOT OBSERVATIONAL STUDY AIIMS RAIPUR. | | ALL INDIA INSTITUTE OF MEDICAL SCIENCES | 02-05-2020 | 20200502 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43432 | Not Recruiting | No | | | | 15-05-2020 | 50 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr PUGAZHENTHAN T→ | | No 2220, IIND FLOOR,DEPARTMENT OF PHARMACOLOGY MEDICAL COLLEGE BUILDING→ | drpugal23@gmail.com→ | 9486279090→ | ALL INDIA INSTITUTE OF MEDICAL SCIENCES AIIMS RAIPUR→ | Inclusion criteria: i) All age group (special: children, all preganant women); <br/ ><br> <br/ ><br>ii) PCR documented SARS-CoV-2 carriage in nasopharyngeal sample at admission whatever their clinical status. <br/ ><br>→ | Exclusion criteria: â?¢ Non consented. <br/ ><br>â?¢ Patients will be excluded if they have a known allergy to hydroxychloroquine /chloroquine and/ or Azithromycin and have any other contraindication to treatment with the study drug(Chloroquine or Azithromycin) including retinopathy, G6PD deficiency and QT prolongation. <br/ ><br>â?¢ Lactating mothers will be excluded based on their declaration. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | virological clearanceTimepoint: day-6 post-inclusion→ | | | | Yes | False | | |
| → | CTRI/2020/05/024983 | 27 January 2021 | Usage of topical lignocaine to decrease the gag reflex
while sampling for Covid-19: Does it affect the yield of
specimen? | Usage of topical lignocaine to decrease the gag reflex
while sampling for Covid-19: Does it affect the yield of
specimen? | | AIIMS New Delhi | 02-05-2020 | 20200502 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43204 | Not Recruiting | No | | | | 05-05-2020 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Alok Thakar→ | | Room no 4057, 4th floor, teaching block, AIIMS, New Delhi Ansari Nagar, New Delhi→ | drathakar@gmail.com→ | 9868397471→ | All India Institute of Medical Sciences→ | Inclusion criteria: RT-PCR proven COVID19 positive cases→ | Exclusion criteria: Pregnancy, minors, refusal to participate, patient on ventilatory support→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Topical Lignocaine: Topical lignocaine lozenges to be used before collecting nasal and throat swabs for Covid-19<br>→ | The sensitivity of nasal and throat swabs for RT-PCR of Covid-19 after topical lignocaine useTimepoint: none→ | | | | Yes | False | | |
| → | CTRI/2020/05/024984 | 27 January 2021 | How has the spread of COVID 19 disease affected the teaching and training of postgraduate students who are studying anaesthesiology | Effect of COVID 19 pandemic on the teaching and training of Anaesthesiology postgraduate students. A questionnaire based survey
| | Sanjay Gandhi Post Graduate Institute of Medical Sciences | 03-05-2020 | 20200503 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43425 | Not Recruiting | No | | | | 12-05-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Rudrashish Haldar→ | | Department of Anaesthesiology,
First Floor, A Block,Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow Rae Bareli Road, Lucknow→ | rudrashish@yahoo.com→ | 9256543256→ | Sanjay Gandhi Post Graduate Institute of Medical Sciences→ | Inclusion criteria: Anaesthesiology postgraduate students(DA/DNB/MD) pursuing postgraduate courses in different medical colleges/ Institutes of India→ | Exclusion criteria: Unwillingness to participate in the survey <br/ ><br>→ | | | Analysis of responses obtained from the 20 point questionnaire sent online to the respondentsTimepoint: One week after the survey has been sent, the responses will be analyzed→ | | 09/05/2020 | | Yes | False | | |
| → | CTRI/2020/05/025010 | 27 January 2021 | Hydroxychloroquine prophylaxis in Covid 19 infection | Generic Protocol on Hydroxychloroquine Prophylaxis for COVID-19 Infection Among Healthcare Workers: A Proof-of-Concept, Observational Study - HCQPRo | | Indian council of Medical Research | 04-05-2020 | 20200504 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43269 | Not Recruiting | No | | | | 04-05-2020 | 2000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Pranab Chatterjee→ | | Indian Council of Medical Research,HQ office
V Ramalingaswami Bhavan,
New Delhi → | dr.madhavieerike@gmail.com→ | 9941476332→ | Indian council of Medical Research→ | Inclusion criteria: All healthcare workers (including doctors, nurses, and other hospital staff) employed by COVID-19 dedicated hospitals, irrespective of their HCQ consumption status, who test negative at the baseline and consent to be included in the study will be eligible for recruitment in the study→ | Exclusion criteria: Healthcare workers who are pregnant or lactating will be excluded based on self-declaration of such status at the baseline evaluation. Those who do not consent to participate will also be excluded. If tested to be COVID-19 positive at baseline, the healthcare worker will be excluded from the study, isolated and managed under standard treatment protocols. <br/ ><br> <br/ ><br>→ | | | The proportion of healthcare workers who likely contracted COVID-19 infection from a nosocomial source in the 12-week period during which they were under HCQ prophylaxisTimepoint: Every week for 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/024989 | 27 January 2021 | Mechanism of Covid 19 infection in Humans | Putative role of TMPRSS2 a serine protease in the pathogenesis of COVID-19 - TMPRSS2 | | Asian HealthCare Foundation | 04-05-2020 | 20200504 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43377 | Not Recruiting | No | | | | 11-05-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr M Sasikala→ | | SurveyNo 136 PlotNo 2/3/4/5 1 Mindspace Rd Gachibowli → | research@aighospitals.com→ | 04042444222→ | AIG Hospitals→ | Inclusion criteria: Patients diagnosed with COVID19 admitted in the hospital: <br/ ><br>-Patients with clinical symptoms such as fever, sore throat and cough and who have been tested positive by RTPCR. <br/ ><br>→ | Exclusion criteria: Patients with clinical symptoms of flu tested negative by RTPCR→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Blood samples from COVID 19 positive cases who have recovered will be analysed for genetic variability in host factors: Blood samples from COVID 19 positive cases who have recovered will be analysed for genetic variability in host factors<br>→ | -Identification of variants in host factors ACE2 receptor and Serine protease in COVID 19 patients in India <br/ ><br>-Mechanism of action of identified variant proteins in viral entry into host cell employing Bioinformatic tools and in vitro testing <br/ ><br>Timepoint: one year→ | | | | Yes | False | | |
| → | CTRI/2020/05/024986 | 27 January 2021 | HOMOEOPATHY IN PREVENTION OF COVID-19 | EFFECTIVENESS OF ARSENICUM ALBUM 30C IN PREVENTION OF COVID-19 IN INDIVIDUALS RESIDING IN HOSPOTS OF RED ZONES IN DELHIâ?? A PROSPECTIVE COHORT STUDY | | Central Council for Research in Homoeopathy | 04-05-2020 | 20200504 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43455 | Not Recruiting | No | | | | 13-05-2020 | 10000 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Raj K Manchanda→ | | Ayurvedic & Unani Tibbia College Campus, Karol Bagh, New Delhi 110005 → | anil23101961@gmail.com→ | 09911127619→ | CCRH→ | Inclusion criteria: â?¢ Suspected cases of Covid 19 infection who <br/ ><br> are asymptomatic <br/ ><br>â?¢ Persons residing in residing in hot spots <br/ ><br> of Delhi. <br/ ><br>â?¢ Age 1 year & above <br/ ><br>â?¢ Both gender <br/ ><br>â?¢ Willing to give verbal informed consent (keeping in view <br/ ><br> contagious nature of disease) <br/ ><br>→ | Exclusion criteria: â?¢ Pregnant women <br/ ><br>â?¢ Lactating mothers <br/ ><br>â?¢ Immunocompromised individuals on basis of <br/ ><br> medical history <br/ ><br>â?¢ Symptomatic (similar to COVID-19) cases <br/ ><br> at quarantine zone. <br/ ><br>â?¢ Not willing to give verbal informed consent <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Homoeopathic Medicine: Homoeopathic medicine Arsenic album 30c will be given to population residing in hot spots of Red zones of Covid-19 out break. The medicine will be given as medicated globules. 2-4 medicated globules will be given twice daily for 7 days.<br>→ | Confirmation of diagnosis for COVID-19 infection / end of quarantine period as per standard protocol.Timepoint: Every 7th day.→ | | | | Yes | False | | |
| → | CTRI/2020/05/024985 | 27 January 2021 | Attempting to pass a breathing tube in a model of human body using two different preventive device as a precautionary measure in the times of COVID | Comparative Evaluation of Intubation Performances Using Two Different Barrier Devices in the COVID era: A Manikin Based Pilot Study | | Sanjay Gandhi Post Graduate Institute of Medical Sciences | 04-05-2020 | 20200504 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43462 | Not Recruiting | No | | | | 13-05-2020 | 40 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Rudrashish Haldar→ | | Dept. of Anaesthesiology,First Floor, A Block, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow Rae Bareli Road, Lucknow→ | rudrashish@yahoo.com→ | 09256543256→ | Sanjay Gandhi Post Graduate Institute of Medical Sciences→ | Inclusion criteria: Anaesthesiologists with experience of greater than 3 years (post MD)→ | Exclusion criteria: Refusal to participate <br/ ><br>Previous training using similar barrier devices <br/ ><br>→ | | | Time taken for successful endotracheal intubationTimepoint: Time taken for successful endotracheal intubation→ | | 30/05/2020 | | Yes | False | | |
| → | CTRI/2020/05/025013 | 27 January 2021 | Evaluation of BCG as potential therapy for COVID-19 | Phase 2 Clinical Trial for the Evaluation of BCG as potential therapy for CoVID-I9 - COVID-19 BCG | | Medical Education and Drugs Department | 05-05-2020 | 20200505 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42858 | Not Recruiting | No | | | | 06-05-2020 | 60 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:On-site computer system Blinding and masking:Participant Blinded | Phase 2 | India→ | Dr Sanjay Mukherjee→ | | 9th floor, Mantralay,
GT Hospital Campus,
Fort, Mumbai 9th floor, Mantralay,
GT Hospital Campus,
Fort, Mumbai→ | u.padmanabhan@haffkineinstitute.org→ | 02224160947→ | Haffkine Institute for Training, Research & Testing→ | Inclusion criteria: Hospitalized subjects either male or female with confirmed COVID-19 will be included in this as per following criteria: <br/ ><br>1. Age 20 - 50 years <br/ ><br>2. Symptomatic subjects with fever (using self-reported questionnaire) plus at least one sign or symptom of respiratory disease including cough, shortness of breath, respiratory distress/failure, runny/blocked nose (using self-reported questionnaire), plus <br/ ><br>3. Positive SARS-Cov-2 test in nasopharyngeal sample at admission (using RT-PCR as prescribed by WHO, ICMR and NCDC)→ | Exclusion criteria: Subjects outside the age group <br/ ><br>Subjects who test negative for nCOV-19 by RT-PCR as per criteria laid down by ICMR. <br/ ><br>Subjects with <br/ ><br>1. Any co-morbidities such as renal distress, cardiac malfunction etc. at time of admission <br/ ><br>2. Any disorder in which natural immune response is altered, <br/ ><br>3. Systemic lupus <br/ ><br>4. Hypogamma-globulinemia, <br/ ><br>5. Congenital immunodeficiency, <br/ ><br>6. Sarcoidosis, <br/ ><br>7. Leukaemia, <br/ ><br>8. Generalised malignancy, <br/ ><br>9. HIV infections or as also those on immunosuppressive therapy, corticosteroids, radiotherapy. <br/ ><br>10. Inchronic eczema or other dermatological disease <br/ ><br>11. Pregnant women, lactating (breast-feeding) women→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J709- Respiratory conditions due to unspecified external agent
→ | Intervention1: BCG (Brand Name Tubervac, Serum Institute of India)<br>Tamiflu<br>Hydroxychloroquine<br>Azithromycin: DOSAGE: 0.1 ml BCG should be administered once during the entire period of the trial<br> <br>ROUTE OF ADMINISTRATION: Intradermal Injection <br><br>COMPOSITION : Live, attenuated BCG Vaccine (Bacillus Calmette-Guerin Strain) Each 1 ml contains between 2 x 106 and 8 x 106 Colony Forming Units (C.F.U.) Diluent: Sodium Chloride Injection I.P.<br>Intervention2: BCG plus STANDARD of CARE as suggested by DCGI: DOSE 0.1 ml<br>ROUTE OF ADMINISTRATION Intradermal<br>FREQUENCY Only once during the entire trial<br>DURATION 1-2 min time required to inject subject. It is not continuous therapy.<br><br>Control Intervention1: Tamiflu<br>Hydroxychloroquine<br>Azithromycin: None<br>Control Intervention2: SALINE plus STANDARD of CARE as suggested by DCGI: DOSE 0.1 ml<br>ROUTE OF ADMINISTRATION Intradermal<br>FREQUENCY Only once during the entire trial<br>DURATION 1-2 min time required to inject subject. It is not continuous therapy.<br>→ | Primary Outcome Measures: <br/ ><br>1.Total duration of Hospitalization with COVID-19 symptoms such as febrile respiratory distress [Time Frame: from admission until discharge] <br/ ><br>2.Decrease in Viral Titer [Time Frame: Measured on day of enrolment, on day 7 and 15 after intervention] <br/ ><br>3.Duration of COVID-19 symptoms [Time Frame: At time of admission, following enrollment until discharge]Timepoint: Primary Outcome Measures: <br/ ><br>1.Total duration of Hospitalization with COVID-19 symptoms such as febrile respiratory distress [Time Frame: from admission until discharge] <br/ ><br>2.Decrease in Viral Titer [Time Frame: Measured on day of enrolment, on day 7 and 15 after intervention] <br/ ><br>3.Duration of COVID-19 symptoms [Time Frame: At time of admission, following enrollment until discharge]→ | | | | Yes | False | | |
| → | CTRI/2020/05/025022 | 27 January 2021 | Hydroxychloroquine in patients with mild COVID-19 illness with risk factors for severe disease | An open label randomised controlled trial to assess the efficacy of Hydroxychloroquine in patients with mild COVID -19 illness with risk factors for severe disease. | | AIIMS Department of Medicine | 05-05-2020 | 20200505 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43183 | Not Recruiting | No | | | | 06-05-2020 | 166 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 2 | India→ | Dr Manish Soneja→ | | Department of Medicine
3rd floor, Teaching Block
AIIMS
Ansari Nagar
ND → | manishsoneja@gmail.com→ | 9013074717→ | AIIMS→ | Inclusion criteria: 1. Patients with RT-PCR confirmed mild COVID-19 illness with high risk factors <br/ ><br>2. Age > 18 years <br/ ><br>3. Written informed consent <br/ ><br>→ | Exclusion criteria: 1. Patients without any of the high risk factors for severe illness <br/ ><br>2. Pregnant women <br/ ><br>3. Known hypersensitivity to HCQ <br/ ><br>4. Known Glucose-6-Phosphate Dehydrogenase (G6PD) deficiency <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tab Hydroxycholoroquine on day 1 followed by 400 mg OD for 5 days: the efficacy of HCQ as treatment for mild COVID-19 with high risk will be elucidated.<br>the safety of HCQ as treatment for mild COVID-19 with high risk characteristics will be addressed .<br>Intervention2: Tab Hydroxychloroquine (HCQ)400 mg BD on day 1 followed by 400 mg OD for total 5 days<br>: Hydroxychloroquine (HCQ), sold under the brand name Plaquenil among others, is a medication used to prevent and treat malaria in areas where malaria remains sensitive to chloroquineommon side effects include vomiting, headache, changes in vision, and muscle weakness<br>Intervention3: HYDROOXYCHLOROQUINE: HCQ 400 MG BD ON DAY 1 FOLLOWED BY 400 MG OD FOR TOTAL 5 DAYS<br>Control Intervention1: SYMPTOMATIC TREATMENT: CONTROL GROUP WILL RECEIVE SYMPTOMATIC TREATMENT which includes paracetamol and other drugs according to symptoms.<br>→ | Progression to moderate- severe diseaseTimepoint: 6 month→ | | | | Yes | False | | |
| → | CTRI/2020/05/025067 | 27 January 2021 | A randomized controlled trial of hydroxychloroquine prophylaxis for Healthcare Workers exposed to COVID-19 | A randomized controlled trial of hydroxychloroquine prophylaxis for Healthcare Workers exposed to COVID-19 | | George Institute for Global Health India | 06-05-2020 | 20200506 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43019 | Recruiting | No | | | | 15-06-2020 | 6950 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | N/A | India→ | Professor Vivekanand Jha→ | | The George Institute for Global Health, India
311-312, Third Floor, Elegance Tower
Plot No. 8, Jasola District Centre → | vjha@georgeinstitute.org.in→ | 911141588091→ | The George Institute for Global Health, India→ | Inclusion criteria: All HCWs directly exposed to confirmed COVID-19 patients.→ | Exclusion criteria: Participants who meet any of following criteria will be are excluded <br/ ><br>1. have a proven diagnosis of COVID-19 infection <br/ ><br>2. are currently taking chloroquine or HCQ <br/ ><br>3. are pregnant <br/ ><br>4. are breast feeding <br/ ><br>5. known QT prolongation <br/ ><br>6. history of serious cardiac dysrhythmias or cardiomyopathy <br/ ><br>7. have maculopathy of the eye (a contra-indication to HCQ) <br/ ><br>8. are immunocompromised because of a disease or therapy <br/ ><br>9. pregnant women→ | | Intervention1: hydroxychloroquine along with Standard care Personal protective equipment: 800 mg of hydroxychloroquine on the day of enrollment and 400mg once a week after that for a total of 12 weeks<br>along with standard care Personal protective equipment<br>Control Intervention1: Standard care Personal protective equipment: standard care Personal protective equipment<br>→ | Proportion of laboratory confirmed symptomatic COVID-19 cases between the groups at the end of 6 monthsTimepoint: Proportion of laboratory confirmed symptomatic COVID-19 cases between the groups at the end of 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/05/025041 | 27 January 2021 | Radiographic findings and their temporal changes in COVID-19 positive patient: A Prospective study | Radiographic findings and their temporal changes in COVID-19 positive patient: A Prospective study | | Max Super Speciality Hospital | 06-05-2020 | 20200506 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43277 | Not Recruiting | No | | | | 06-05-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rajesh Saxena→ | | Max Super Speciality Hospital Mandir Marg Press Enclave Road Saket New Delhi → | saroj.kumar@maxhealthcare.com→ | 9999325464→ | Max Super Speciality Hospital→ | Inclusion criteria: Patients confirmed positive for COVID-19 by rRT-PCR irrespective of age.→ | Exclusion criteria: Patients with flu like symptoms but negative for COVID-19 by rRT-PCR.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1.Determine the radiographic findings in chest X-ray of COVID-19 positive patients.Timepoint: At Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/05/025049 | 27 January 2021 | A CLINICAL TRIAL TO STUDY THE EFFICACY OF HOMOEOPATHIC MEDICINE IN PREVENTION AND CURE OF CORONA VIRUS DISEASE 19 | PROVING THE EFFICACY OF HOMOEOPATHIC TREATMENT IN PREVENTION AND CURE OF COVID 19 | | SAI NIDAN HOMOEOPATHY CLINIC | 06-05-2020 | 20200506 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43313 | Not Recruiting | No | | | | 08-05-2020 | 100 | Interventional | Cluster Randomized Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | DR DHIRENDRA TIWARI→ | | SAI NIDAN HOMOEOPATHY CLINIC
NEAR SAI MANDIR , BANARAS ROAD, AMBIKAPUR,CHHATTISGARH,
→ | drdhiren16@yahoo.co.in→ | 8770568212→ | SAI NIDAN HOMOEOPATHY CLINIC→ | Inclusion criteria: MALES OR FEMALES WITH A DIAGNOSIS OF COVID 19 AND MALES OR FEMALES QUARANTINE PERSON FOR COVID 19→ | Exclusion criteria: NIL→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ARSENIC ALBUM 30: HOMOEOPATHIC MEDICINE ARSENIC ALBUM IN POTNTISED FORM OF 30 CENTICIMAL POTENCY OD DAILY FOR 3 DAYS<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | Primary endpoint of this trial will be measured in terms of clinically recovered cases (covid 19 negative)or deathTimepoint: 1 MONTH→ | | | | Yes | False | | |
| → | CTRI/2020/05/025069 | 27 January 2021 | Ayurvedic Interventions in prevention of COVID-19 infection-A survey study | Impact of Ayurvedic Interventions in prevention of COVID-19 infection in containment areas of Delhi- A community based study | | Central Council For Research in Ayurvedic Sciences | 07-05-2020 | 20200507 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43522 | Not Recruiting | No | | | | 16-05-2020 | 9200 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Dr Babita Yadav→ | | Central Council for Research in Ayurvedic Sciences
61-65 Institutional Area
Oppo. D Block
Janakpuri
New Delhi → | drbabitayadav@gmail.com→ | | Central Council for Research in Ayurvedic Sciences→ | Inclusion criteria: 1 Aged 18 to 70 years of both male or female <br/ ><br>2 Residents of the identified containment zones, marked by Govt. of <br/ ><br>NCT Delhi for high risk of COVID 19 <br/ ><br>3 Willing to take study medication; <br/ ><br>4 Provides written informed consent prior to initiation of study <br/ ><br>procedures (or legally authorized representative). Only the copy of <br/ ><br>photography of informed consent would be kept for records.→ | Exclusion criteria: 1 Persons already treated with any of the study drugs during the last 30 days; <br/ ><br>2 Pregnant and lactating females and those who have a pregnancy plan <br/ ><br>3 Participants with any immunosuppressive medication or in an immune <br/ ><br>compromised state or haematological disease. <br/ ><br>4 Laboratory confirmed COVID-19 with or without symptoms. <br/ ><br>5 Known allergy to any of the medications used in this trial. <br/ ><br>6 Not willing to participate in the study. <br/ ><br>7 Any other criteria, as per the investigator would jeopardize the study.→ | | Intervention1: Shanshamani Vati or<br>Sudarshana Ghanavati or Ashwagandha: 1.Sanshamani Vati 500mg Two times Before meal with water for 1 month<br>2.Sudarshna Ghanavati 500mg two times before meal with water for 1 month<br>3. Ashwagandha 500 mg two times before meal with water for 1 month<br>Total duration of therapy is 1 month<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | Incidence of COVID 19 positive cases (as confirmed by hospital by standard investigation (real-time polymerase chain reaction test) among Ayurveda usersTimepoint: 3) After enrolment on day one, assessment will be done on day 7, 15, 22 and 30 by telephonic communication or as convenient to the participant.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025070 | 27 January 2021 | An Observational study to identify the issues and challenges in cancer patients on active treatment during the COVID-19 Pandemic and the resulting Lockdown | An Observational study to identify the issues and challenges in cancer patients on active treatment during the COVID-19 Pandemic and the resulting Lockdown | | MAX SUPER SPECIALITY HOSPITAL | 07-05-2020 | 20200507 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43343 | Not Recruiting | No | | | | 09-05-2020 | 150 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | RAJESH SAXENA→ | | 108 A, IP EXTENSION,
PATPARGANJ, NEW DELHI → | Geeta.Kadayaprath@maxhealthcare.com→ | 9810169286→ | Max Super Speciality Hospital Patparganj→ | Inclusion criteria: i. Registered with the Max Institute of Cancer Care between Nov 1st 2019 to Jan 31st 2020 <br/ ><br>ii. Were scheduled to receive one or more modalities of treatment (chemotherapy, surgery, radiation therapy, immunotherapy) during the period Feb 1st 2020 to April 30th 2020 <br/ ><br>→ | Exclusion criteria: → | Health Condition 1: C00-D49- Neoplasms
→ | | Our study aims to identify the challenges faced by oncology patients during the pandemic.Timepoint: 09-05-2020 to 30-06-2020→ | | | | Yes | False | | |
| → | CTRI/2020/05/025068 | 27 January 2021 | Can a medicine help in curing viral infection | A Phase IIB open label randomized controlled trial to evaluate the efficacy and safety of Ivermectin in reducing viral loads in patients with hematological disorders who are admitted with COVID 19 infection - Not applicable | | Christian Medical College Vellore | 07-05-2020 | 20200507 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43449 | Not Recruiting | No | | | | 27-05-2020 | 50 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | Biju George→ | | Department of Haematology,
First Floor, Room no-3,
Christian Medical College Department of Haematology,
First Floor, Room no-3,
Christian Medical College→ | biju@cmcvellore.ac.in→ | 04162282352→ | Christian Medical College Vellore→ | Inclusion criteria: Confirmed diagnosis of COVID19 infection based on +ve RTPCR <br/ ><br> <br/ ><br>→ | Exclusion criteria: Patients with other viral infections→ | Health Condition 1: B338- Other specified viral diseases
→ | Intervention1: Ivermectin: The doses are as follows (based on body weight)<br>15 - 24 kg: 3 mg PO once<br>25 - 35 kg: 6 mg PO once<br>36 - 50 kg: 9 mg PO once<br>51 - 65 kg: 12 mg PO once<br>66 - 79 kg: 15 mg PO once<br>80 kg and 15 kg: 200 ug/kg PO once<br>Control Intervention1: patients will receive the standard protocol for management of COVID 19 infection.: patients will receive the standard protocol for management of COVID 19 infection.<br>→ | To study if Ivermectin can reduce the viral load in patients with hematological illnesses who are admitted with COVD19 infectionTimepoint: Day 7 <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/05/025071 | 27 January 2021 | Clinical trial evaluating two ventilator settings in Corona virus related severe lung diseases ( known as ARDS) | Driving pressure guided positive end expiratory pressure (PEEP) strategy Vs physician guided PEEP (ARDSnet protocol) in mechanical ventilation for Acute respiratory distress syndrome (ARDS) in COVID-19 patients: a prospective randomised controlled trial. | | All India Institute of Medical Sciences | 08-05-2020 | 20200508 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43447 | Not Recruiting | No | | | | 16-05-2020 | 40 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded | Phase 3 | India→ | Dr Ajisha Aravindan→ | | Dept of Anaesthesiology, Pain Medicine and Critical care
4th Floor Porta Cabin
Academic Block
AIIMS → | ajishaa@gmail.com→ | 9810597276→ | All India Institute of Medical Sciences→ | Inclusion criteria: All adult patients > 16 years of age of either sex fulfilling WHO case definition of COVID-19 positive with ARDS (Berlin Criteria) needing invasive mechanical ventilation→ | Exclusion criteria: Relatives who refuse to give consent or have unproven/suspected COVID-19 infection <br/ ><br>age <16 years of age <br/ ><br>BMI <18 kg/m2 or >40kg/m2 <br/ ><br>pregnant <br/ ><br>increased intracranial pressure <br/ ><br>severe neuromuscular disease <br/ ><br>severe chronic respiratory disease <br/ ><br>severe chronic liver disease <br/ ><br>active malignancy→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Lowest driving pressure guided PEEP: Initial PEEP would be kept at 5 cmH2O and driving pressure would be noted. PEEP would be stepped up in increments of 1 and the corresponding Î?P would be checked after 1 minute. The PEEP levels at which Î?P is the least would be chosen. In case the driving pressure achieved is same for more than one consecutive value of PEEP, then the lowest level of PEEP would be chosen.<br>After 12 hours, driving pressures would be checked again and the same protocol would be followed to find the lowest Î?P. If it is noted at any point that Î?P increases with increase in PEEP, then PEEP would be reduced in decrements of 1 until the lowest Î?P is achieved. The rest of the ventilator settings would be as per ARDSnet protocol.<br>Control Intervention1: Conventional lung protective ventilation strategy( ARDSnet protocol): Ventilator settings used would be as per the PEEP/FiO2 combinations used in ARDSnet protocol.<br>→ | Difference in the area under the curve (adjusted to survival time) for Murrayâ??s lung injury score between the two groups in the first 4 days.Timepoint: The first 4 days during ICU stay and mechanical ventilation→ | | | | Yes | False | | |
| → | CTRI/2020/05/025088 | 27 January 2021 | Study of GUDUCHI TABLET on healthy individuals to prevent covid 19. | Observational Study of GUDUCHI TABLET intake as a preventive measure in pandemic of COVID-19 â?? An open label, Randomized, Controlled, Prospective, Interventional, Community-based Clinical study on healthy subjects | | central council for rsearch in ayurvedic sciences | 09-05-2020 | 20200509 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43555 | Not Recruiting | No | | | | 20-05-2020 | 1200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 1/ Phase 2 | India→ | Dr B vankatshwarlu→ | | Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada.
→ | drcvenkat@rediffmail.com→ | 6301340787→ | Regional ayurveda research instutute vijayawada→ | Inclusion criteria: 1.Adult Male or Female subjects above the age of 18 years to 68 years. <br/ ><br>2.Subjects who are froma community where at least 1 confirmed case is already identified. <br/ ><br>3.Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br>→ | Exclusion criteria: 1.Pregnant and Lactating females <br/ ><br>2.Known cases of uncontrolled Diabetes and Hypertension. <br/ ><br>3.Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4.Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>5.Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>7.Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. <br/ ><br>8.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol <br/ ><br>→ | | Intervention1: Guduchi tablet: Tab Guduchi 500mg twice daily for one month<br>Control Intervention1: nil: nil<br>→ | 1. Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic CareTimepoint: 15th day, 30th day, 45th day→ | | | | Yes | False | | |
| → | CTRI/2020/05/025089 | 27 January 2021 | Effect of Hydroxychloroquine on QTc Interval | Effect of Hydroxychloroquine Prophylaxis on QTc Interval of Health Care Workers during COVID-19 Pandemic: An Observational Study | | SGPGIMS | 09-05-2020 | 20200509 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43506 | Recruiting | No | | | | 18-05-2020 | 50 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Mohan Gurjar→ | | Department of Critical Care Medicine,
SGPGIMS,
Lucknow (UP). 226014
India → | m.gurjar@rediffmail.com→ | | Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)→ | Inclusion criteria: All HCWs who have been advised for HCQ as prophylaxis during their posting to manage COVID-19 confirmed or suspected patients.→ | Exclusion criteria: Not on HCQ prophylaxis.→ | | | Change in QTc intervalTimepoint: Before and after HCQ prophylaxis→ | | | | Yes | False | | |
| → | CTRI/2020/05/025093 | 27 January 2021 | Study of effect of Yashtimadhu tablet for the prevention of COVID -19 on healthy individuals. | Observational Study of YASHTIMADHU TABLET intake as a preventive measure in pandemic of COVID-19 â?? An open label, Randomized, Controlled, Prospective, interventional, Community-based Cclinical study on healthy subjects
| | Ministry of AYUSH | 11-05-2020 | 20200511 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43539 | Not Recruiting | No | | | | 18-05-2020 | 1200 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Dr Sujata pundlikrao Dhoke→ | | Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada. → | narivbd.vijayawada@gmail.com→ | 8096455323→ | Regional Ayurveda research institute for skin disorders→ | Inclusion criteria: 1.Adult Male or Female subjects above the age of 18 years to 68 years. <br/ ><br>2.Subjects who are from a community where at least 1 confirmed case is already identified. <br/ ><br>3.Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br>→ | Exclusion criteria: 1.Pregnant and Lactating females <br/ ><br>2.Known cases of uncontrolled Diabetes and Hypertension. <br/ ><br>3.Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4.Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>5.Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6.Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>7.Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. <br/ ><br>8.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol→ | | Intervention1: Yashtimadhu tablet: YASHTIMADHU TABLET -250 mg X 2 tablets b.d.<br>for one month<br><br>Control Intervention1: nil: nil<br>→ | 1.Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic CareTimepoint: 15,30 and 45th day → | | | | Yes | False | | |
| → | CTRI/2020/05/025092 | 27 January 2021 | Outcomes of viral infection in hematology patients | Clinical profile and outcomes of COVID 19 infection in patients with hematological disorders - Not applicable | | Science and Engineering Research Board SERB | 11-05-2020 | 20200511 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43608 | Not Recruiting | No | | | | 28-05-2020 | 250 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Biju George→ | | Room no-3, Department of Haematology,
Christian Medical College,
Vellore → | biju@cmcvellore.ac.in→ | 04162282352→ | Christian Medical College Vellore→ | Inclusion criteria: 1) Cases will be all patients with haematological disorders diagnosed to have COVID 19 infection <br/ ><br>2) Controls will be patients with other viral respiratory infections. <br/ ><br>3)If we are unable to get adequate controls, we will acquire de-identified data from the department database on patients who were diagnosed to have viral respiratory illness during 2018 â?? 2019. They will be matched as closely as possible for age [child vs adult], sex, chemotherapy vs transplant and underlying illness. <br/ ><br>→ | Exclusion criteria: 1) Patients with asymptomatic COVID-19 <br/ ><br>2) Patients in whom SARS-CoV-2 viral load at diagnosis is not available <br/ ><br>3) Patients with a diagnosis of either bacterial or fungal respiratory infection <br/ ><br>→ | Health Condition 1: B342- Coronavirus infection, unspecified
→ | Intervention1: Not applicable: Not applicable<br>Control Intervention1: Not applicable: Not applicable<br>→ | To study the clinical profile and outcomes of COVID 19 infection in patients with <br/ ><br>Hematological disordersTimepoint: DAY 8→ | | | | Yes | False | | |
| → | CTRI/2020/05/025091 | 27 January 2021 | Knowledge status of public about COVID 19 disease prevention and control in Tamil Nadu | AAwareness and practices regarding COVID-19 related prevention, control and promotive measures among population in containment zone in Chennai , Tamil Nadu, India: Cross-sectional study | | Siddha Central Research Institute | 11-05-2020 | 20200511 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43622 | Not Recruiting | No | | | | 20-05-2020 | 549 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr C Anbarasi→ | | Siddha Central Research Institute, Central Council for Research in Siddha, Anna Hospital Campus,Arumbakkam,
Chennai → | meenaprakashphd@gmail.com→ | | Siddha Central Research Institute→ | Inclusion criteria: People in containment zone→ | Exclusion criteria: aged < 18 years <br/ ><br>those not willing to participate <br/ ><br>severely ill or not in a position to be interviewed <br/ ><br>→ | | | Estimate awareness regarding COVID-19 prevention, control and promotive measures among population Estimate practices regarding COVID-19 prevention, control and promotive measures among populationTimepoint: 90 days→ | | 01/08/2020 | | Yes | False | | |
| → | CTRI/2020/05/025114 | 27 January 2021 | A Clinical Study on Favipiravir Compared to Standard Supportive Care in Patients With Mild to Moderate COVID-19. | A Randomized, Open-label, multicenter study to evaluate the efficacy and safety of Favipiravir combined with STANDARD supportive care in adult Indian patients with mild to moderate COVID-19 | | Glenmark Pharmaceuticals Ltd | 12-05-2020 | 20200512 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43504 | Not Recruiting | No | | | | 20-05-2020 | 150 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3 | India→ | Amol Pendse→ | | Glenmark Research Centre,
Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai
→ | Pawan.Singh@glenmarkpharma.com→ | 02250451200→ | Glenmark Pharmaceuticals Ltd→ | Inclusion criteria: Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures. <br/ ><br>Age 18-75 years (inclusive) at the time of signing ICF. <br/ ><br>Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization). <br/ ><br>For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test. <br/ ><br>Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment. <br/ ><br>Not participating in any other interventional drug clinical studies before completion of the present study. <br/ ><br>Additional Inclusion criteria for mild cases only: <br/ ><br>Time interval between symptoms onset and randomization to no more than 7 days. <br/ ><br>Pyrexia (temperature < 102.2oF); respiratory rate 12 to â?¤20/min. <br/ ><br>No more than four of the following of mild severity, and no more than two of moderate severity (Mild is defined as symptoms not requiring any or minimal therapeutic intervention; moderate is defined as symptoms which produce small impairment of function and require some form of therapeutic intervention; severe is defined as symptoms resulting in marked impairment of function): <br/ ><br>Cough <br/ ><br>Sore throat <br/ ><br>Headache <br/ ><br>Nasal congestion <br/ ><br>Body aches and pains <br/ ><br>Fatigue <br/ ><br>Additional Inclusion criteria for moderate cases: <br/ ><br>Patients with the interval between symptoms onset and randomization is no more than 10 days <br/ ><br>Chest imaging (CT as first option or X-ray if CT not possible)-documented pneumonia <br/ ><br>Patients with pyrexia (axillary â?¥ 98.6°F or oral â?¥ 99.5°F); respiratory rate > 20 to < 30/min. <br/ ><br> <br/ ><br>→ | Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: <br/ ><br>Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely. <br/ ><br>Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ ><br>Inability to intake or tolerate oral medications. <br/ ><br>Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN. <br/ ><br>Gout/history of gout or hyperuricemia (above the ULN). <br/ ><br>Prolonged QT, defined as QTcF â?¥ 450 milliseconds for men and as QTcF â?¥ 470 for women <br/ ><br>Known severely reduced LV function (Ejection fraction < 30 %). <br/ ><br>Oxygen saturation (SPO2) â?¤ 93 % or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2)â?¤ 300 mmHg; <br/ ><br>Requires ICU care for management of ongoing clinical status. <br/ ><br>Known allergy or hypersensitivity to Favipiravir; <br/ ><br>Known severe renal impairment [creatinine clearance (CrCl) < 30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis; <br/ ><br>Asthma or chronic obstructive lung disease <br/ ><br>Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year). <br/ ><br>Pregnant or lactating women; <br/ ><br>Having used Favipiravir or participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ ><br>Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Favipiravir 200mg Tablets: Dosage Form: Tablets. <br>Dosage Frequency: 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days.<br>Mode of Administration: Oral<br><br>Control Intervention1: Standard Supportive Care: These patients will be managed by standard supportive care.<br>→ | Time until cessation of oral shedding of SARS-CoV-2 virus [ Time Frame: Up to 28 days ] (Time in days from randomization to a negative SARS-CoV2 RT-PCR result of both oropharyngeal swab and nasopharyngeal swab).Timepoint: Up to 28 days→ | | 15/06/2020 | | Yes | False | | |
| → | CTRI/2020/05/025156 | 27 January 2021 | Effect of Ayurveda intervention AYUSH-64 add-on therapy for patients with COVID-19 infection (Stage I) | Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush-64) add-on therapy for patients with COVID-19 infection (Stage I)-A Randomized controlled clinical trial | | Central Council for Research in Ayurvedic Sciences | 13-05-2020 | 20200513 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43590 | Not Recruiting | No | | | | 18-05-2020 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Dr R Govind Reddy→ | | Regional Ayurveda Research Institute for Mother and Child Health (RARIMCH)
Near Gharkul Parisar Nandanvan Nagpur Maharashtra 440009 → | drrgreddy68@gmail.com→ | 9820284671→ | Regional Ayurveda Research Institute for Mother and Child Health, Nagpur→ | Inclusion criteria: 1.Patients of 18-60 yrs of age, clinically diagnosed with corona virus disease 2019 by RTPCR test coming under stage I- mild (Early infection)- Group A, B, C as per TREATMENT PROTOCOL FOR CONFIRMED COVID-19 PATIENTS (Maharashtra Health Services_15 April 2020.) <br/ ><br>2.Participants who can take medicines orally. <br/ ><br>3.Patients willing to provide signed informed consent. <br/ ><br>→ | Exclusion criteria: 1.Pregnant, Lactating women, patients with CKD (Chronic Kidney Disease). <br/ ><br>2.Not willing to participate in the study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Group I: Ayurveda intervention AYUSH-64 as add-on to standard treament: AYUSH 64: 2 Tablets (500mg each) thrice daily with water after meal for 1 month<br>Control Intervention1: Group II: Standard treatment for COVID-19 infection: Standard treatments for COVID-19 infection as per Maharashtra guidelines<br>→ | 1.Clinical cure rate: Time to negative conversion of severe acute respiratory syndrome corona-virus 2.Timepoint: At baseline, 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/025163 | 27 January 2021 | Surgery Outcomes in COVID patients | Outcomes of surgery in COVID-19 infection: international cohort study - CovidSurg | | University of Birmingham | 13-05-2020 | 20200513 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43610 | Not Recruiting | No | | | | 20-05-2020 | 3000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Benin;France;India;Italy;Mexico;Pakistan;Zambia;United States of America;United Kingdom;Spain;South Africa;Rwanda;Philippines→ | Dhruva Nath Ghosh→ | | Department of Pediatric Surgery
Christian Medical College Hospital
Brown Road → | dhruvghosh73@gmail.com→ | 9915198894→ | Christian Medical College Ludhiana→ | Inclusion criteria: 1. Patients undergoing ANY type of surgery in an operating theatre, this includes obstetrics. <br/ ><br>AND <br/ ><br>2. The patient had COVID-19 infection diagnosed within 7 days before or 30 days after surgery, based on <br/ ><br> 1.positive COVID-19 lab test or computed tomography (CT) chest scan. <br/ ><br>OR <br/ ><br> 2.clinical diagnosis (no COVID-19 lab test or CT chest performed). <br/ ><br>→ | Exclusion criteria: If COVID-19 infection is diagnosed >30 days after surgery, the patient should not be included.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: O- Medical and Surgical
Health Condition 3: 1- Obstetrics
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | 30-day mortality <br/ ><br>To determine 30-day mortality in patients with COVID-19 infection who undergo surgery. This will inform future risk stratification, decision making, and patient consent.Timepoint: 30 days (4 weeks) <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/05/025160 | 27 January 2021 | Outcomes Of Cancer Surgery During COVID-19 Pandemic | Outcomes of elective cancer surgery during the COVID-19 pandemic crisis: an
international, multicentre, observational cohort study - CovidSurg-Cancer | | University Of Birmingham United Kingdom | 13-05-2020 | 20200513 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43628 | Not Recruiting | No | | | | 25-05-2020 | 7000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Australia;Benin;Canada;France;Ghana;India;Italy;Mexico;Nigeria;Pakistan;Philippines;Rwanda;South Africa;Spain;United Arab Emirates;United Kingdom;United States of America;Zambia→ | Dhruva Nath Ghosh→ | | Department Of Pediatric Surgery
Christian Medical College Hospital
Brown Road → | pdhaque@gmail.com→ | 9872630178→ | Christian Medical College Ludhiana→ | Inclusion criteria: 1. Any centres performing elective cancer surgery are eligible for participation. <br/ ><br>2. Adults (age â?¥18 years) with a confirmed diagnosis of an included cancer type <br/ ><br>3. Multidisciplinary team (tumour board) decision for (or would have been made for) surgical management with a curative intent during the pre-COVID-19 era.→ | Exclusion criteria: 1. Surgery planned with non-curative intent. <br/ ><br>2. Planned neoadjuvant therapy without a firm date for surgery, or awaiting restaging.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: O- Medical and Surgical
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | 30-day postoperative COVID-19 infection rateTimepoint: 30-day postoperative COVID-19 infection rate→ | | 01/09/2020 | | Yes | False | | |
| → | CTRI/2020/05/025162 | 27 January 2021 | Effect of pranayama and meditation on psychological well-being of healthcare workers during COVID-19 pandemic. | Effect of alternate nostril breathing and guided meditation practice on sleep quality, psychological distress and coping skills of healthcare workers during COVID-19 pandemic | | Jawaharlal Institute of Postgraduate Medical Education and Research | 13-05-2020 | 20200513 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43650 | Recruiting | No | | | | 26-05-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Balaji Bharadwaj→ | | Room 1081, Ground Floor,
Hospital Block,
JIPMER Hospital,
Dhanvantri Nagar,
→ | bharadwaj.balaji@gmail.com→ | 9489147796→ | Jawaharlal Institute of Postgraduate Medical Education and Research→ | Inclusion criteria: 1. Healthcare workers (doctors or nursing staff) of JIPMER, Pondicherry <br/ ><br>2. Age between 18 to 60 years→ | Exclusion criteria: 1. Those who are regular practitioners of pranayama or meditation, defined as practicing any method of pranayama or meditation or both for at least 50% of days in the last 1 month period <br/ ><br>2. Those who are having symptoms of moderate or severe Influenza-Like Illness at present <br/ ><br>3. Those who are already diagnosed to have COVID infection <br/ ><br>4. Those who have pre-existing severe mental illnesses such as Bipolar disorder or schizophrenia <br/ ><br>5. Participants who have been diagnosed to have tuberculosis, Chronic Obstructive Pulmonary Disease, Chronic sinusitis 6. Severe sleep problems defined as less than 3 hours of sleep everyday for the preceding 7 days 7. Those whose spouse is also participating, either one will be recruited for the study by random selection.→ | | Intervention1: Alternate Nostril Breathing <br>& <br>Guided Meditation: (1) Nadi Shodhan Pranayama â?? Alternate nostril breathing will be taught where the participant is seated comfortably with spine erect, head straight and eyes closed gently. The left hand will be placed in chin mudra with the thumb and index fingers opposing each other and in a gentle touch. The rest of three fingers are kept straight. The right hand is used to perform the alternate nostril breathing such that the thumb is on the right nostril, index and middle fingers between the eyebrows and ring and little fingers. The participants are then taught the procedure to breath through alternate nostrils for about 5 mins. (2) Panchakosha Meditation â?? The participants will be asked to sit with eyes closed and listen to the instructions given. The Panchakosha meditation is a guided meditation that takes about 15 to 18 minutes. After which participants are again asked to do the Nadi Shodhan Pranayama for about 5 minutes.<br>The participants will then be given the instructions for daily practice of this pranayama and meditation technique by giving them the YouTube links for the other guided meditation techniques.<br>These interventions will be delivered by the Principal Investigator who has been trained as a teacher by the Art of Living Foundation in the teaching of these techniques. The session will be conducted remotely using Zoom video calling app.<br>At the end of two weeks period, the participants will be asked to again respond to an online questionnaire which will assess their psychological parameters, sleep quality and coping abilities. At this point, the Intervention Arm participants will be asked to return a sheet that marks their adherence to the protocol.<br>Control Intervention1: Waitlisted Control: The control→ | Pittsburgh Sleep Quality Index (PSQI) for sleep qualityTimepoint: 0, 2 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/025161 | 27 January 2021 | To study the Effectiveness of herbal formulation - Aayudh Advance as a supplementary treatment for the Corona Virus 2019 (Covid-19) infected patients | A Randomized and Comparative Study to assess Safety and Efficacy of Supplemental Treatment of a herbal formulation - Aayudh Advance comprising essential oils in patients with Corona Virus 2019 (Covid-19) | | Ms Shukla Ashar Impex Pvt Ltd | 13-05-2020 | 20200513 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43442 | Not Recruiting | No | | | | 16-05-2020 | 120 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Dr Manish Rachchh→ | | Opp. Pharmez,
Changodar - Bavla Highway,
Near Matoda Patia, Post: Matoda,
Ahmedabad, Gujarat, India → | vd.ganatra@gmail.com→ | 9825497588→ | Ganatra Ayurveda & Panchkarma Clinic→ | Inclusion criteria: 1) Subject willing to sign informed consent. <br/ ><br>2) Subject age group of 18 years and above of both gender. <br/ ><br>3) All patients with COVID-19 RT-PCR positive (within 7 days)/ any Covid-19 test kit, admitted to the hospital / healthcare center will be eligible. <br/ ><br>4) Patients who are having mild to moderate symptoms of Covid-19 disease and tested positive for Covid-19 test. <br/ ><br>→ | Exclusion criteria: 1) Patient younger than18 years age. <br/ ><br>2) Women who are pregnant or who intend to become pregnant for the next three months after taking the drug. <br/ ><br>3) Patients allergic to type medications or any of the ingredient of the formulation. <br/ ><br>4) Patients with a neurological history (seizures, epilepsy, etc.). <br/ ><br>5) Patients with a previous history of psychiatric illnesses (depression, anxiety, suicide attempt). <br/ ><br>6) Patients with severe cardiac pathologies or relevant chronic diseases that in the judgment of the clinician recommend the non-inclusion of the patient in the study. <br/ ><br>7) Patients who are on artificial ventilation or oxygen supply. <br/ ><br>8) Very severe patients of Covid 19. <br/ ><br>9) Patients with severe hypertension, diabetes and other chronic diseases shall be excluded. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Herbal formulation - Aayudh Advance: Herbal formulation - Aayudh Advanced is a health supplement that helps boost immunity. This product is made from all-natural farm grown extracts. Each essential oil added into this concoction has been specially chosen for its individual immunomodulatory and protective characteristics. When mixed, these oils yield synergistic effect to protect the body from bacteria, viruses and fungi. Their potency is further increased when the mixture is converted into colloids. These colloids provide exponential efficacy that makes the product highly desirable health supplement, immunity booster, bactericide and virucide. <br><br>Dose is 10 ml three times a day orally before meal. <br><br>The study shall be from Patients initiation of treatment till complete recovery and discharge from the hospital.<br>Control Intervention1: As Standard treatment suggested by WHO: As standard treatment suggested by WHO For Covid-19 Patients.<br><br><br>The study shall be from Patients initiation of treatment till complete recovery and discharge from the hospital.<br>→ | 1) Rate of Recovery <br/ ><br>2) Symptom Resolution: Fever <br/ ><br>3) Symptom Resolution: Cough <br/ ><br>4) Symptom Resolution: Shortness of breath <br/ ><br>Timepoint: Every 3-4 days from patient enrollment till recovery of patient and discharged from hospital→ | | 15/06/2020 | | Yes | False | | |
| → | CTRI/2020/05/025166 | 27 January 2021 | Study of ASHWAGANDHA TABLET on healthy individuals to prevent covid 19 | Observational Study of ASHWAGANDHA TABLET intake as a preventive measure in pandemic of COVID-19 â?? An open label, Randomized, Controlled, Prospective, Interventional, Community-based Clinical study on healthy subjects
| | Ministry of Ayush Government of India | 14-05-2020 | 20200514 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43553 | Not Recruiting | No | | | | 19-05-2020 | 1200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr C Muralikrishna→ | | Regional Ayurveda Research Institute for Skin disorders, New Rajeev nagar, Payakapuram Vjayawada. → | mkchagamreddy@gmail.com→ | 9492030564→ | Regional Ayurveda Research Institute Vijayawada→ | Inclusion criteria: 1.Adult Male or Female subjects above the age of 18 years to 68 years. <br/ ><br>2.Subjects who are from community where at least 1 confirmed case is already identified. <br/ ><br>3.Subjects who are ready to provide written/digital informed consent and who are willing to participate→ | Exclusion criteria: 1.Pregnant and Lactating females <br/ ><br>2.Known cases of uncontrolled Diabetes and Hypertension. <br/ ><br>3.Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>5. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>7.Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. <br/ ><br>8.Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol <br/ ><br>→ | | Intervention1: Ashwagandha tablet: Ashwagandha tablet (250mg ) two tablet twice daily for one month<br>Control Intervention1: nil: nil<br>→ | Primary outcome parameter: <br/ ><br>1. Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic Care <br/ ><br>Timepoint: 15th day , 30th day and 45th day→ | | | | Yes | False | | |
| → | CTRI/2020/05/025178 | 27 January 2021 | Evaluation of the Immuno-Stimulatory Potential (Shareera Bala) of an Ayurveda Management Protocol in Cohort of Quarantined Delhi Police under Covid-19 Care Centers- An Exploratory Clinical Study | Evaluation of the Immuno- stimulatory Potential (Shareera Bala) of an Ayurveda management protocol in Cohort of Quarantined Delhi police under Covid-19 care centers- An Exploratory clinical study - APCOVIDA | | All India Institute of Ayurveda | 14-05-2020 | 20200514 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43557 | Not Recruiting | No | | | | 18-05-2020 | 140 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2 | India→ | Dr VG Huddar→ | | 6th floor, room no 610,All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi 6th floor, room no 610,All India Institute of Ayurveda, Gautampuri, Sarita Vihar, New Delhi→ | dr.vghuddar@aiia.gov.in→ | 9986697942→ | All India Institute Of Ayurveda→ | Inclusion criteria: 1.Available police personnel of either sex aged 19-60 years <br/ ><br>2.Delhi Police personnel quarantined for COVID-19 infection. <br/ ><br>3.Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals. <br/ ><br>4.Individuals agree to give consent for participation→ | Exclusion criteria: 1.Individuals with uncontrolled co morbid conditions which may affect the Bala of the Individual. <br/ ><br>2.Already suffering with severe respiratory allergies and other conditions which may create bias in the outcome results <br/ ><br>3.Individuals found positive for COVID 19 during the course of medication. Defined as: temperature > 38 Celsius; cough; shortness of breath; sore throat; or, if available (not required), positive confirmatory testing for COVID-19 <br/ ><br>4.Previously diagnosed with COVID-19 <br/ ><br>5.Subjects on other prophylactic medications. <br/ ><br>6.Concurrent condition that in the investigatorâ??s opinion would jeopardize compliance with the protocol.→ | | Intervention1: group-A: 1. TabSamshamani Vati 250 mg 2 bid after food with water for 60 days<br>2. Herbal tea â?? 150 ml in the morning once daily for 60 days( Preparation of Herbal tea: Boil 150 ml (1 glass) of water, at the time of boiling add 1 small tsf (3gms) of powder boil for 1-2 minutes. Switch off the stove and keep the lid for 1-2 mins till it settles and this herbal tea is ready to drink warm after filtering)<br>3. Application of Anu taila This oil is to be applied locally inside both the nostrils. This is to be applied in the morning before b and before leaving home and before retiring to bed.<br>4. Haridra khanda , 3gms bid with milk before food. (if sore throat, cold, cough seen)<br>Control Intervention1: group-B: conventional medicine preventive guidelines<br>→ | Improvement in Bala of an individual <br/ ><br>Immuno-stimulation leading to non-development of symptoms of CoVID-19 in risk population exposed to infected individuals. (Bala will be assessed by using specialised proforma including dashavidha pareeksha and other questionnaires which will reveal the physical and mental health of an individual.)Timepoint: Baseline, 15th day, 30th day, 45th day, 60th day and 90th day→ | | | | Yes | False | | |
| → | CTRI/2020/05/025167 | 27 January 2021 | Evaluation of Efficacy and Safety of Thymoquinone compared to Best supportive care in Patients with COVID-19 | Evaluation of Efficacy and Safety of Thymoquinone compared to Best supportive care in Patients with COVID-19. | | Intas Pharmaceuticals Ltd | 14-05-2020 | 20200514 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43378 | Recruiting | No | | | | 17-05-2020 | 100 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Mr Prashant Modi→ | | Lambda House, Department of Project Management & Regulatory Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G. Highway,Gota → | namanshah@lambda-cro.com→ | 07940202389→ | Lambda Therapeutic Research Ltd→ | Inclusion criteria: 1.Ability to provide signed and dated informed consent. <br/ ><br>2. Male or female aged â?¥ 18 and â?¤65 years of age. <br/ ><br>3. Patients who meets the following criteria: a. With confirmed COVID-19 infection as defined below <br/ ><br> i. Has laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcription- polymerase chain reaction (RT-PCR) or other commercial or public health assay in any specimen, collected <72 hours prior to enrollment; AND <br/ ><br>ii. Asymptomatic patients without any signs or symptoms as defined in clinical management guidelines for COVID-19 infection issued by the Ministry of Health and Family Welfare (MOHFW); OR Mild (uncomplicated) illness of any duration not requiring hospitalization, and without extreme shortness of breath or severe prostration meeting following criteria: <br/ ><br> 1. Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND <br/ ><br> 2. No signs of any serious lower airway disease as defined in clinical management guidelines for COVID-19 infection issued by MOHFW AND <br/ ><br> 3. RR <20, HR <90, oxygen saturation (pulse oximetry) >93% on room air at screening.→ | Exclusion criteria: 1. Severe COVID-19 including but not limited to: <br/ ><br>a. respiratory failure (defined by endotracheal intubation and mechanical ventilation, noninvasive positive pressure ventilation, or clinical diagnosis of respiratory failure in setting of resource limitations) <br/ ><br>b. Multiple organ dysfunction/failure <br/ ><br> c. Systolic BP <90 mmHg or Diastolic BP < 60 mm Hg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support <br/ ><br> 2. Confirmed or suspected diagnosis of Acute Respiratory Distress Syndrome (ARDS) at screening <br/ ><br>3. History of severe chronic respiratory disease and requirement for long-term oxygen therapy <br/ ><br> 4. Expected need for mechanical ventilation within the next 24 hours <br/ ><br> 5. Expected survival of less than 96 hours at the time of presentation <br/ ><br> 6. Receiving renal replacement therapy/dialysis <br/ ><br> 7. Currently receiving or has received in the last 14 days, experimental immune modulators and/or monoclonal antibody therapies <br/ ><br> 8. Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry <br/ ><br>9. Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline <br/ ><br> 10. Patients who have received organ transplantation or major surgery in the past 6 months. <br/ ><br> 11. Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal, or Patients with child-Pugh grade C cirrhosis. <br/ ><br> 12. Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the Patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Thymoquinone 50 mg tablet as an add on to best supportive as per guidelines of clinical management of COVID-19 as issued by MOHFW.: Dose : 50 mg once daily for 14 days<br>Control Intervention1: best supportive care: Best supportive care will be as defined in Guidelines on Clinical Management of COVID-19 issued by MOHFW.<br>→ | To characterize virologic and clinical response of Thymoquinone in patients diagnosed with COVID-19 <br/ ><br>Timepoint: 1. Virologic outcome <br/ ><br> a. Change in positive COVID-19 status on day 8 and day 15 <br/ ><br>2. Clinical outcomes <br/ ><br> a. Proportion of Patients on WHO progression scale 0 to 10 on day 8 and day 15.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025171 | 27 January 2021 | Ayurveda protocol & COVID-19 exposed individuals: Clinical trial of an Ayurveda Intervention | Evaluation of the Immuno-stimulatory(Shareera Bala) potential of Ayurveda management protocol in Cohort of Delhi Police - An Exploratory clinical Study - EBAMD | | All India Institute of Ayurveda | 14-05-2020 | 20200514 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43487 | Not Recruiting | No | | | | 16-05-2020 | 50000 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2 | India→ | Dr VG Huddar→ | | 6th floor,room no 610, All India Institute Of Ayurveda Gautampuri, Sarita Vihar, New Delhi 6th floor, room no 610, All India Institute Of Ayurveda, Gautampuri, Sarita Vihar, New Delhi→ | dr.vghuddar@aiia.gov.in→ | 9986697942→ | All India Institute Of Ayurveda→ | Inclusion criteria: 1.Available police personnel of either sex aged 19-60 years <br/ ><br>2.All Delhi Police personnel having risk of exposure to COVID-19 infection. <br/ ><br>3.Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals. <br/ ><br>4.Individuals agree to give consent for participation <br/ ><br>→ | Exclusion criteria: 1.Individuals with chronic co morbid conditions which has affected the Bala of the Individual. <br/ ><br>2.Already suffering with severe respiratory allergies and other conditions which may create bias in the outcome results <br/ ><br>3.Individuals found positive for COVID 19 during the course of medication. Defined as: temperature > 38 Celsius; cough; shortness of breath; sore throat; or, if available (not required), positive confirmatory testing for COVID-19 <br/ ><br>4.Previously diagnosed with COVID-19 <br/ ><br>5.Subjects on other prophylactic medications. <br/ ><br>6.Concurrent condition that in the investigatorâ??s opinion would jeopardize compliance with the protocol. <br/ ><br>→ | | Intervention1: group A -Tab Samshamani Vati <br>2.Anu taila<br>3.rock salt and turmeric duration<br>4.Ayush preventive guidelines: 1.Tab Samshamani Vati 250 mg 2 bid after food with water <br>2.Application of Anu taila 2 drops each nostrils once a day after bath in the morning<br>3.Gargle with warm water mixed with rock salt and turmeric<br>4.Ayush preventive guidelines for COVID 19 with Yoga and Pranayama- for 8 week<br><br>Control Intervention1: Group B: Conventional preventive medicine guidelines<br>→ | Improvement in Bala of an individual <br/ ><br>Immuno-stimulation leading to non-development of symptoms of CoVID-19 in risk population exposed to infected individuals. <br/ ><br>(Bala will be assessed by using specialized proforma including dasvidha pareeksha and other questionnaires which will revel the physical and mental health of an individuals)Timepoint: 8 week <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/05/025184 | 27 January 2021 | Psychological impact of COVID â?? 19 Pandemic | Psychological impact of COVID â?? 19 Pandemic: Web based cross sectional study - PSY: COVID-19 | | NIL | 15-05-2020 | 20200515 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43600 | Not Recruiting | No | | | | 19-05-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India;United Arab Emirates;United States of America→ | Dr Vivian Kapil V→ | | Dept of Psychiatry (Room No 23),
Sri Ramachandra Institute of Higher Education and Research,
No.1, Ramachandra Nagar,
Porur, Chennai. Dept of Psychiatry (Room No 23),
Sri Ramachandra Institute of Higher Education and Research,
No.1, Ramachandra Nagar,
Por→ | viviankapil23@gmail.com→ | 9445431311→ | Sri Ramachandra Institute of Higher Education Research→ | Inclusion criteria: 1. Participants aged 18 years and above. <br/ ><br>2. Participants will be recruited from regions afflicted with the COVID â?? 19 <br/ ><br> Outbreak. <br/ ><br>3. Willing to participate in the study. <br/ ><br>4. Ability to read, write and understand English language. <br/ ><br>→ | Exclusion criteria: 1. Participants who are less than 18 years of age. <br/ ><br>2. Participants who suffer from a known primary psychiatric disorder. <br/ ><br>3. Participants from regions not affected with the COVID -19 pandemic. <br/ ><br>4. Participants who are unwilling to participate in the study. <br/ ><br>→ | | | Distress Scores (GHQ-12 Scores)Timepoint: Distress Scores (GHQ-12 Scores) at Baseline only is taken for the study (cross sectional study)→ | | | | Yes | False | | |
| → | CTRI/2020/05/025194 | 27 January 2021 | Mental status of public during lockdown COVID-19 | Assessment of Psychosocial behaviour in COVID-19 QUARANTINE in South India - PHOBIC | | Narrain Shree | 15-05-2020 | 20200515 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43664 | Not Recruiting | No | | | | 22-05-2020 | 280 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Narrain shree s→ | | No 4 Guru Flats Pavendhar Bharathi Dasan Salai Mahalakshmi Nagar Madipakkam Santhigiri Siddha Medical College
Pothencode
Thiruvananthapuram→ | vinodvnp@gmail.com→ | 9496134889→ | Siddha Central Research Institute→ | Inclusion criteria: Anybody having access to internet can answer this survey. Commonly the age group will be 18 to 60 years of age since usage of mobile phones and internet are been more in this age group of people. The people participating in this survey will be from the southern states like Andhra Pradesh, Telangana, Karnataka, Tamilnadu, Pudhuchery and Kerala where the lockdowns are been imposed. Through the link if consented the participants will be able to view the questions by clicking on it→ | Exclusion criteria: People who does not have Internet Access <br/ ><br>COVID-19 Positive Cases <br/ ><br>People who does not belonging to geographical areas like Tamilnadu, Kerala, Puducherry, Telangana, Andhra Pradesh and Karnataka→ | | | The results obtained will give the psychosocial emotions created by the lockdown which will be the primary objective of the analysis and secondary objectives like the rate of impact of lockdown on existing lifestyle disorders may also get evaluated. This survey helps in developing new aspects/concepts on quarantine in futureTimepoint: 0th day, 15th day, 30th day, 45th day→ | | | | Yes | False | | |
| → | CTRI/2020/05/025182 | 27 January 2021 | Siddha interventions prevention to front line workers | Assessment of prophylaxis offered to front line workers who have involved themselves in warfooting of COVID-19 in Tamilnadu who are taking Siddha Interventions like Nilavembukudineer / Kabasurakudineer. | | Central council for research in Siddha | 15-05-2020 | 20200515 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43680 | Not Recruiting | No | | | | 22-05-2020 | 366 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrPSathiyarajeswaran→ | | Anna Hospital Campus Arumbakkam Anna Hospital Campus Arumbakkam→ | siddha2k6@gmail.com→ | 8754495186→ | Department of Clinical Research Siddha central research Institute→ | Inclusion criteria: Front line workers can answer this survey. Commonly the age group will be 20 to 60 years of age. The people participating in this survey will be from Tamilnadu. Through the questionnaire issued they may give consent→ | Exclusion criteria: Front line workers who became positive and quarantined.→ | | | The results obtained will give the benefit of prevention offered among the front line workers who take these interventions as prophylaxis .By comparing the back ground data from health workers who have not exposed to prophylaxis the benefit can be calculated. This survey helps in establishing prophylaxis on quarantine in future .Timepoint: 0th day, 15th day, 45th day and 60th day→ | | | | Yes | False | | |
| → | CTRI/2020/05/025213 | 27 January 2021 | Ayurveda formulation for COVID-19 prevention | Impact of Ayurvedic intervention (Guduchighan vati)in prevention of COVID-19 infection in containment areas of Himachal Pradesh-A community based study | | Central Council for Research in Ayurvedic Sciences | 15-05-2020 | 20200515 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43698 | Not Recruiting | No | | | | 23-05-2020 | 1500 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Kavita Vyas→ | | Ground floor Room number 3 Regional Ayurveda research institute for nutritional disorders Jaral Pandoh District Mandi → | kavitakrishu@gmail.com→ | 8219339718→ | Central Council for Research in Ayurvedic Sciences→ | Inclusion criteria: Residents of the identified containment zones, marked by government of Himachal Pradesh for high risk of COVID 19 <br/ ><br>Willing to take study medication, <br/ ><br>Provides written informed consent prior to initiation of study Procedures. <br/ ><br>→ | Exclusion criteria: Persons already treated with study drug during the last 30 days; <br/ ><br>Pregnant and lactating females and those who have a pregnancy plan. <br/ ><br>Participants with any immunosuppressive medication or in an immune Compromised state or hematological disease. <br/ ><br>Laboratory confirmed COVID-19 cases with or without symptoms. <br/ ><br>Known allergy to the medication used in this trial. <br/ ><br>Not willing to participate in the study. <br/ ><br>Any other criteria, as per the investigator would jeopardize the study. <br/ ><br>→ | | Intervention1: Guduchi ghan vati: drug to be given in dose of 500mg BD with lukewarm water before meals for 30 days<br>Control Intervention1: Not applicable: not applicable<br>→ | Incidence of COVID 19 positive cases as confirmed by hospital by standard investigation, real time polymerase chain reaction test among Ayurveda users.Timepoint: At baseline,1 week, 2 weeks, 3 weeks, 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/025205 | 27 January 2021 | Arsenicum album â?? 30 as prophylactic for Covid-19 | Effectiveness of Arsenicum Album 30c in Prevention of Covid-19 in Individuals Residing in Hot Spots of Red Zonesâ?? A Multicentric, Randomised, Cluster Level, Controlled Trial | | Central Council for Research in Homoeopathy | 15-05-2020 | 20200515 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43721 | Not Recruiting | No | | | | 24-05-2020 | 33000 | Interventional | Cluster Randomized Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Dr Debadatta Nayak→ | | Epidemic cell, Room no-303
61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 → | drdnayak@gmail.com→ | 09873404012→ | CCRH→ | Inclusion criteria: â?¢ High risk contacts of Covid 19 infection who are asymptomatic and residing in hotspots. <br/ ><br>â?¢ Age 1 year & above <br/ ><br>â?¢ Both gender <br/ ><br>â?¢ Willing to give verbal informed consent or written informed consent as the situation may be (keeping in view contagious nature of disease) <br/ ><br>→ | Exclusion criteria: â?¢ Pregnant women or lactating mothers <br/ ><br>â?¢ Immunocompromised individuals on basis of medical history. <br/ ><br>â?¢ Symptomatic (similar to COVID-19) cases at quarantine zone. <br/ ><br>â?¢ Not willing to give informed consent/verbal consent. <br/ ><br>→ | | Intervention1: Arsenicum album 30C: The Arsenicum album 30C will be given to the high risk contact of COVID 19 cases and residing in hotspots of containment zone. The 4 pills of medicine will be given orally twice daily for 7 days.<br>Control Intervention1: No intervention.: The control group clusters will receive no tretment. However the will be under observation similar to medicine group.<br>→ | 1. Confirmation of diagnosis for COVID-19 infection based on RT-PCR / end of quarantine period as per standard protocol.Timepoint: Every third day till 21st day.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025214 | 27 January 2021 | To observe the effect of Ayurvedic medicine for the treatment of COVID-19 | A Randomized, Open Label, Parallel Efficacy, Active Control, Exploratory Clinical Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation (AYUSH 64) as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients | | Central Council for Research in Ayurvedic Sciences | 15-05-2020 | 20200515 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43727 | Not Recruiting | No | | | | 24-05-2020 | 80 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Sumit Shrivastva→ | | 77, Chandi Path, Sector 46B, Sector 46
Room No. 116, Ground floor,
Shri Dhanwantry Ayurvedic Hospital→ | sumitpankaj@gmail.com→ | 9781110780→ | Shri Dhanwantry Ayurvedic College and Hospital→ | Inclusion criteria: 1.Typical clinical presentation of acute onset febrile illness with cough and a RT_PCR based laboratory confirmation test for COVID-19 <br/ ><br>2.Typical clinical presentation of acute onset febrile illness with sore throat and dry cough with or without shortness of breath in a patient from a known â??hot spotâ?? area or in close contact with a confirmed COVID-19 case with a negative laboratory test for COVID 19 and H1N1 influenza <br/ ><br>3.Patients with either sex, 18 to 75 years age <br/ ><br>4.Patients with mild-moderately severe disease <br/ ><br>5.All patients must agree not to share medication <br/ ><br>6.Patients willing to participate and sign an informed consent Understands and agrees to comply with planned study procedures. <br/ ><br>7.Agrees to the give OP swabs and venous blood for testing as per protocol. <br/ ><br>→ | Exclusion criteria: 1. Patients suffering from severe COVID-19 Disease as judged by a physician and fulfilling at least two of the following three criteria (i) Respiratory distress at room ambience (equal or more than 30 breaths per min) (ii) Oxygen saturation at rest equal or less than 93% (peripheral digital arterial oxymetry) and requiring oxygen support for over one hour to normalize (iii) Any of the known COVID-19 complications and emergency procedures which may require shift/admission in intensive care unit such as respiratory failure, adult respiratory distress syndrome, requirement of oxygen support for over 1 hour, requirement of mechanical ventilation, septic shock, or severe non-respiratory organ dysfunction or failure. <br/ ><br>2.Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study <br/ ><br>3. History of immunosuppression: solid organ or bone marrow transplant, use of immunosuppressive antimetabolic and biologic agents, intrinsic immunodeficiencies, HIV infection. <br/ ><br>4. Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. <br/ ><br>5. Patients on parenteral nutrition <br/ ><br>6. Patients with known sensitivity or contraindication to any of the ingredients of study medication <br/ ><br>7. History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.) <br/ ><br>8. Patients who are likely to worsen or planed ICU admission or ventilator support due to any reason <br/ ><br>9. Pregnancy and lactation <br/ ><br>10. Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19 <br/ ><br>11. Participation in any other clinical trial of an experimental agent treatment for COVID-19 <br/ ><br>12. Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind. <br/ ><br>13. Physician decision that involvement in the study is not in the patient´s best interest <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: AYUSH 64: Dose:2 capsules (500 mg each) thrice daily<br>Dosage form:Capsules/Tablets <br>Route of Administration: Oral<br>Time of Administration: Thrice a day after food<br>Anupana: Water <br>Duration of therapy: 30 days<br><br>Control Intervention1: Conventional standard therapy for COVID-19 positive patients: Conventional standard therapy as per ICMR/WHO parameters<br>→ | a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery <br/ ><br>b) Proportion of patients showing â??clinical recoveryâ??. <br/ ><br>Timepoint: On 7th day, 15th day, 23rd day and 30th day→ | | | | Yes | False | | |
| → | CTRI/2020/05/025183 | 27 January 2021 | Questionnaire based study of drugs taken by healthcare workers to prevent COVID 19 | ICMR â?? RUMC COVID 19 Study for the
Assessment of Prophylaxis For Health Care Workers
| | Indian Council of Medical Research ICMR | 15-05-2020 | 20200515 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43241 | Not Recruiting | No | | | | 18-05-2020 | 5000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Denis Xavier→ | | Dept of Pharmacology, St. Johns Medical College,
Sarjapura Road, Koramangala. Bangalore → | denis.xavier@stjohns.in→ | 9886126801→ | St. Johns Medical College→ | Inclusion criteria: All consenting Health Care Workers working in ICMR RUMC and collaborating hospitals caring <br/ ><br>for Covid-19 patients→ | Exclusion criteria: Nil→ | | Control Intervention1: NIL: NIL<br>→ | In HCW working in hospitals caring for COVID 19 patients, we will understand the rates of and types of drugs used, doses taken for prophylaxis, concomitant illness, concomitant medications, adverse reactions if any and the COVID-19 status at the end of the prophylaxis period. We will also understand the reasons why HCW did not take prophylaxis or discontinued.Timepoint: To be studied at the end of 12 weeks of prophylaxis or later if the recommendations change→ | | 30/09/2020 | | Yes | False | | |
| → | CTRI/2020/05/025212 | 27 January 2021 | Assessing Stress levels among the Health Care Workers during and after Outbreak of
COVID-19 | Assessing Stress levels among the Health Care Workers during and after Outbreak of
COVID-19 in the setting of tertiary radiation facility in India | | Dr JAI PRAKASH AGARWAL | 15-05-2020 | 20200515 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43757 | Not Recruiting | No | | | | 25-05-2020 | 350 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr J P Agarwal→ | | Tata Memorial Center,
Room no 1127, Homi Bhabha Block, Department of Radiation Oncology, Parel → | agarwaljp@tmc.gov.in→ | 24177000→ | Tata Memorial Center, Mumbai→ | Inclusion criteria: All the HCW in the department of radiation oncology will be approached for this study at <br/ ><br>all TMC sites. It will include staff at all cadres and disciplines (oncologists, physicists, technologists, <br/ ><br>assisting, administrative and project staff).→ | Exclusion criteria: Personnel unable to fill the English versions of the <br/ ><br>instruments will be excluded.→ | | | To study anxiety, depression and post-traumatic stress disorder among the HCW <br/ ><br>in the radiation oncology department during the COVID-19 outbreak.Timepoint: 1 year→ | | | | Yes | False | | |
| → | CTRI/2020/05/025209 | 27 January 2021 | A clinical trial for validating therapeutic efficacy of convalescent plasma in severe COVID-19 disease | AN OPEN LABEL RANDOMISED
CONTROL TRIAL ON PASSIVE IMMUNIZATION WITH CONVALESCENT PLASMA IN SEVERE COVID-19 DISEASE - PICP19 | | Council of Scientific and Industrial Research | 15-05-2020 | 20200515 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43251 | Recruiting | No | | | | 20-05-2020 | 80 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 2 | India→ | Dipyaman Ganguly→ | | CSIR-Indian Institute of Chemical Biology
4 Raja S.C. Mullick Road
Jadavpur → | jaggs.nbmc@gmail.com→ | 9830126060→ | Calcutta School of Tropical Medicine→ | Inclusion criteria: Patients admitted with RNA PCR proven COVID-19 with <br/ ><br>severe disease (fever or suspected respiratory infection, plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 < 90% at room air) <br/ ><br>with Mild ARDS (200 mmHg < PaO2/FiO2 â?¤ 300 mmHg, with PEEP or CPAP â?¥5 cm H2O, or non-ventilated) <br/ ><br>or Moderate ARDS (100 mmHg < PaO2/FiO2 â?¤200 mmHg, with PEEP â?¥5 cm H2O, or non-ventilated) <br/ ><br>within 5 to 10 days from initial presentation. <br/ ><br>→ | Exclusion criteria: 1. Pregnant mothers <br/ ><br>2. Patients with age less than 18 years <br/ ><br>3. Admitted late after 10 days of initial presentation <br/ ><br>4. Patients refusing consent <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Passive Immunization using Convalescent Plasma in COVID-19: Blood group matched convalescent Plasma (COVID Plasma) from recovered COVID-19 patients will be transfused to patients with severe COVID-19 diseases<br>200ml COVID Plasma will be intravenously transfused once daily on two consecutive days.<br>Control Intervention1: Standard of care: Standard of care<br>→ | 2. To compare â??all causeâ?? mortality <br/ ><br>3. To identify the immune correlates for response to plasma therapy. <br/ ><br>Timepoint: 1. Discharge <br/ ><br>2. Discharge/death <br/ ><br>3. Day 0, Day 3, Day 7 after admission→ | | | | Yes | False | | |
| → | CTRI/2020/05/025216 | 27 January 2021 | HCQ POCKET ECG Ambulatory Telemetry Study | Evaluation of Cardiac Safety of Hydroxychloroquin for pre COVID 19 Exposure Prophylaxis : Smart Remote Continuous Ambulatory Electrocardiographic Study | | Rohit Walia | 16-05-2020 | 20200516 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43755 | Not Recruiting | No | | | | 26-05-2020 | 30 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rohit Walia→ | | Room number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh → | rwalia7731@yahoo.in→ | 8800492549→ | All India Institute of Medical Science Rishikesh→ | Inclusion criteria: people taking pre exposure COVID 19 hydroxychloroquin prophylaxis <br/ ><br> Written informed consent→ | Exclusion criteria: Corrected QT greater than 480 ms <br/ ><br>Known congenital Long QT <br/ ><br>Co moralities and contraindications to hydroxychloroquin <br/ ><br>Retinopathy <br/ ><br>Known hypersensitivity to chloroquine <br/ ><br>Cardiomyopathy, prolonged QTc, cardiac arrhythmias â?¢ History of psoriasis, porphyria cutanea tarda <br/ ><br>Epilepsy <br/ ><br>Myasthenia gravis, myopathy of any cause <br/ ><br>Serious hepatic or renal disease <br/ ><br> Known glucose-6-phosphate dehydrogenase deficiency <br/ ><br>Current use of medication with known serious hepatotoxic effects or known interaction with chloroquine <br/ ><br>Severe depression <br/ ><br> Electrolyte imbalance <br/ ><br>Anti arrhythmic drugs <br/ ><br>Cardiac devices like pacemaker , defibrillators→ | | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | No of patients with QT prolongation by 25 percentage of baseline <br/ ><br> No of patients with QT prolongation greater than 500 ms <br/ ><br>No of patients with ventricular arrhythmias <br/ ><br>Syncope <br/ ><br>Sudden cardiac DeathTimepoint: 7 days→ | | | | Yes | False | | |
| → | CTRI/2020/05/025215 | 27 January 2021 | Effectiveness of Siddha medicine, Kabasura kudineer and vitamin c-zinc supplementation in the management of Mild COVID 19 patients. | A prospective, single centre, randomized open labelled comparative clinical study to evaluate the effectiveness of Siddha medicine, Kabasura kudineer and vitamin c-zinc supplementation in the management of asymptomatic COVID 19 patients. | | Dean | 16-05-2020 | 20200516 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43769 | Not Recruiting | No | | | | 25-05-2020 | 50 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 1/ Phase 2 | India→ | Dr C Anbarasi→ | | Arignar Anna hospital Campus
Arumbakkam
Chennai → | drnatarajan78@gmail.com→ | | Siddha Central Research Institute→ | Inclusion criteria: 1.Laboratory confirmed COVID-19 without symptoms <br/ ><br>2.Consenting to participate in the study and sign the informed consent <br/ ><br>→ | Exclusion criteria: 1.Patient with co morbid conditions like DM, HT, BA <br/ ><br>2.Patients with severe primary respiratory disease or other pathogenic microbial pneumonia that needs to be identified with COVID-19 <br/ ><br>3.Pregnant and mothers, those who have a pregnancy plan. <br/ ><br>4.Patients with other systemic malignant diseases such as malignant tumors, mental illnesses, etc., which the researchers consider unsuitable for participation in the study <br/ ><br>5.People who have been allergic to Siddha medicine or intolerant to taking medicine <br/ ><br>6.Patients participating in other COVID-19 clinical trials <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Kabasura Kudineer: 60 ml bd for 14 days<br>Control Intervention1: Vitamin C, Zinc supplementation: Vitamin C - 60000IU OD for 14 days<br>Zinc supplementation - 100mg od for 14 days<br>→ | Reduction in incidence of clinical symptoms of COVID 19 <br/ ><br>Negative conversion of SARS-CoV-2 <br/ ><br>Reduction in Viral load of SARS-CoV-2 at the end of treatment <br/ ><br>Examine the levels immune markers and inflammatory markersTimepoint: 14 days→ | | 15/06/2020 | | Yes | False | | |
| → | CTRI/2020/05/025217 | 27 January 2021 | COVID-19 and cancer chemotherapy | COVID-19 and cancer chemotherapy- collate data on treatment patterns, short-term outcomes and patient experience | | Dr Bhawna Sirohi | 17-05-2020 | 20200517 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43015 | Recruiting | No | | | | 29-05-2020 | 200 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Dr Bhawna Sirohi→ | | Max Super Speciality Hospital, Saket
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket, New Delhi
Max Super Speciality Hospital, Saket
(A unit of Devki Devi Foundation)
2, Press Enclave Road, Saket, New Delhi- 110017
→ | bhawna.sirohi13@gmail.com→ | 9756999976→ | Max healthcare→ | Inclusion criteria: All adult (more than 18 years of age) cancer patients currently on active chemotherapy treatment at Max Institute of Cancer Care→ | Exclusion criteria: Patients not able to give consent <br/ ><br>Patient less than 18 years age on the day of enrollment→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | | To describe change in cancer treatment patterns as a result of the pandemicTimepoint: 6 months from start of enrollment→ | | | | Yes | False | | |
| → | CTRI/2020/05/025220 | 27 January 2021 | To study the effect of COVID-19 pandemic and Psychological Well-being of Healthcare Professionals and Support Staff in Max Super Speciality Hospital, Saket in New Delhi, India. | Impact of COVID-19 Pandemic on Psychological Wellbeing of Healthcare Professionals in India | | Hiba Siddiqui | 17-05-2020 | 20200517 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43619 | Not Recruiting | No | | | | 20-05-2020 | 1300 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Hiba Siddiqui→ | | Max Super Speciality Hospital,A Unit of Devki Devi Foundation,2,Press Enclave Road,Saket 272 Jamia Nagar Teachers College Road,New Delhi→ | hiba.siddiqui16@gmail.com→ | 9911175205→ | Max Super Speciality Hospital,Saket→ | Inclusion criteria: 1. Healthcare professionals working in Max Super Speciality Hospital,Saket,New Delhi. <br/ ><br>2.Healthcare professionals inclusive of doctors,nurses,paramedics,front office employee and support staff. <br/ ><br>3.Healthcare professionals above 18years of age. <br/ ><br>4.Healthcare professionals residing in India.→ | Exclusion criteria: 1.Non-employees of Max Super Speciality Hospital,Saket,New Delhi. <br/ ><br>2.Healthcare professionals residing outside India.→ | | | Specific to the sub-scale domain assessed, individual psychotherapy sessions would <br/ ><br>be provided to the identified healthcare professionals reporting severity of psychological <br/ ><br>distress and if the individual is in need of further management or somatic symptom <br/ ><br>related treatment, they will be guided for pharmacotherapy.Timepoint: 3months→ | | | | Yes | False | | |
| → | CTRI/2020/05/025219 | 27 January 2021 | To find out what has happened to the treatment and care of children suffering with cancer in India during the lockdown from the COVID-19 pandemic | The impact on COVID-19 pandemic on the care of children with cancer in India | | Dr Ramandeep Singh Arora | 17-05-2020 | 20200517 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43750 | Not Recruiting | No | | | | 26-05-2020 | 1250 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ramandeep Arora→ | | Department of Medical Oncology, Max Institute of Cancer Care,
2 Press Enclave Marg
Saket Institutional Area
Saket → | childhoodcancer@gmail.com→ | 8375017305→ | Max Super Speciality Hospital→ | Inclusion criteria: Children aged 0 to 18 years with cancer (diagnosed and initiated treatment for the first time or those with relapse)registered during a five-month time period from Jan 1st 2020 to May 31st 2020.→ | Exclusion criteria: Those who do not meet inclusion criteria→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | | % change in number of children registered, % of chemotherapy given behind schedule or not givenTimepoint: 10 week time period→ | | | | Yes | False | | |
| → | CTRI/2020/05/025221 | 27 January 2021 | Create registry of Childhood Cancer patients in India with COVID 19 to provide guidelines for prevention and treatment | Indian COVID-19 Childhood Cancer Registry | | Dr Ramandep Arora | 17-05-2020 | 20200517 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43753 | Not Recruiting | No | | | | 26-05-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ramandeep Arora→ | | Max Superspeciality Hospital (A Unit of Devki Devi foundation) 2 Press Enclave Marg Saket Institutional Area Saket
→ | childhoodcancer@gmail.com→ | 8375017305→ | Max Super Speciality Hospital→ | Inclusion criteria: 1. All children who at diagnosis of their cancer were < 18 years of age <br/ ><br>2. They are now either on therapy including chemotherapy, immunotherapy, radiotherapy and surgery, or have completed therapy <br/ ><br>3. Confirmed diagnosis of COVID-19 by RT-PCR or antibody test <br/ ><br>4. Located in India at the time of the diagnosis of COVID-19 <br/ ><br>→ | Exclusion criteria: 1. Those who refuse consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | | Mortality rate at 30 days from diagnosis of COVID-19 Treatment abandonment rates at 90 days from diagnosis of COVID-19 <br/ ><br>Timepoint: Day 30 <br/ ><br>Day 90→ | | | | Yes | False | | |
| → | CTRI/2020/05/025218 | 27 January 2021 | A survey for challenges faced by the Investigators during COVID-19 pandemic in the conduct of Clinical Trials at Tata Memorial Centre. | A survey to assess the challenges faced by the Investigators during COVID-19 pandemic in the conduct of Clinical Trials at Tata Memorial Centre. | | Tata Memorial Centre | 17-05-2020 | 20200517 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43772 | Not Recruiting | No | | | | 25-05-2020 | 40 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Gouri Pantvaidya→ | | Tata Memorial Hospital, Parel Tata Memorial Hospital, Parel→ | docgouri@gmail.com→ | 22-24177262→ | Tata Memorial Hospital→ | Inclusion criteria: Investigators conducting trials at Tata Memorial Centre.→ | Exclusion criteria: Nil→ | | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | Challenges faced by the investigators in conducting trials during COVID-19.Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/05/025222 | 27 January 2021 | Efficacy of Tablet AOIM - Z in Prevention of COVID - 19 in High Risk Healthy Police Personnel | Evaluation of Clinical Efficacy of AOIM â?? Z Tablets for Prevention of COVID â?? 19 Pandemic in High Risk Healthy Police Personnel â?? Single Arm, Open Labelled, Prospective Exploratory Interventional Clinical Study | | Shree Dhootapapeshwar Limited | 18-05-2020 | 20200518 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43803 | Not Recruiting | No | | | | 01-06-2020 | 275 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 4 | India→ | Dr Vedvati Bhapkar→ | | Department of Rasashastra & Bhaishajya Kalpana, School of Ayurveda, D. Y. Patil deemed to be University, Nerul east, Navi Mumbai D. Y. Patil Deemed to be University, School of Ayurveda, Nerul, Navi Mumbai→ | vinay.pawar@dypatil.edu→ | 7506631982→ | D. Y. Patil Deemed to be University, School of Ayurveda→ | Inclusion criteria: 1. Healthy, Male or Female participants between the age group of 21 to years to 55 years (both inclusive). <br/ ><br>Healthy police personnel will be considered as those who do not have any acute medical condition or chronic medical/surgical condition that requires either immediate or continuous medical monitoring and treatment. <br/ ><br>2. Participants who are ready to provide written informed consent and who are ready to voluntarily participate and abide to the protocol requirements <br/ ><br>→ | Exclusion criteria: 1. Pregnant and Lactating females <br/ ><br>2. Participants who have been quarantined or confirmed of having COVID-19 and have been isolated for its treatment. Participants having recently suffered and recovered of COVID-19 will also be excluded from the study <br/ ><br>3. Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4. Participants having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. <br/ ><br>5. Participants taking steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Participants participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study. <br/ ><br>7. Other conditions, which in the opinion of the investigators makes the subject unsuitable for enrolment or could interfere in adherence to of the study protocol <br/ ><br>→ | | Intervention1: AOIM - Z Tablets: One tablet twice a day for 90 days<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | Prevention of Incidence of COVID â?? 19 infection in study participantsTimepoint: 6 weeks(45 days) and 12 weeks (90 days)→ | | | | Yes | False | | |
| → | CTRI/2020/05/025224 | 27 January 2021 | Study to efficacy of Ivermectin in patients of COVID-19 | Interventional study to assess the efficacy of Ivermectin with standard of care treatment versus standard of care in patients of COVID-19 at R D Gardi Medical College, Ujjain, India | | R D Gardi Medical College | 18-05-2020 | 20200518 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43728 | Not Recruiting | No | | | | 24-05-2020 | 50 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2 | India→ | Dr Ashish Pathak→ | | 3rd Floor, Department of Pediatrics
C R Gardi Hospital R D Gardi Medical College Agar Road, Surasa→ | drashish.jpathak@gmail.com→ | 9302239899→ | R D Gardi Medical College→ | Inclusion criteria: 1. Adults (age â?¥18 years to â?¤75 years) 2. Laboratory-confirmed SARS-CoV-2 infection and, in the view of the responsible doctor, no contra-indication to any of the study treatments 3. Hospitalized at R D Gardi Medical College, Ujjain Madhya Pradesh→ | Exclusion criteria: 1. Anticipated transfer to another hospital, within 72 hours, which is not a study site 2. Known allergy to study medication or its components (non-medicinal ingredients) 3. Known HIV infection→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ivermectin: Ivermectin 12mg OD at night <br>Route of administration- Oral<br>Duration of therapy - 2 days with standard of care as per hospital guidelines<br><br>Intervention2: Ivermectin: Ivermectin 200 to 400 mcg per kg body weight<br>Control Intervention1: Standard of care: Standard of care as per hospital guidelines.<br>→ | Effect of Ivermectin on eradication of virus. <br/ ><br>Test for virus at 1, 3 and 5 days from beginning of trial drug started for the patient in the hospital <br/ ><br>Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/05/025242 | 27 January 2021 | Hydroxychloroquine of pharmacokinetics in healthcare workers | Population pharmacokinetics of hydroxychloroquine sulphate in healthcare workers given for prophylaxis against Corona Virus Disease 2019 (COVID 19) pandemic in India | | Indian Council of Medical Research | 19-05-2020 | 20200519 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43057 | Not Recruiting | No | | | | 25-05-2020 | 400 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Nithya Gogtay→ | | Dept of Clinical Pharmacology 1st floor MS building
Seth GSMC and KEM Hospital Acharya Donde marg Parel Mumbai → | njgogtay@hotmail.com→ | | Department of Clinical Pharmacology Seth GSMC and KEM Hospital→ | Inclusion criteria: Asymptomatic Health Care workers (HCWs) of any gender and conditions as follows: <br/ ><br>age 18 -65 years (HCW who are actively on duty and not any who have retired) on prophylaxis with HCQ against COVID-19 infection â?? Group 1 without comorbiditie <br/ ><br>age 18 -65 years (HCW who are actively on duty and not any who have retired) who are to be initiated on prophylaxis â?? Group 2 without comorbidities <br/ ><br>age 18 -65 years (HCW who are actively on duty and not any who have retired) on prophylaxis with HCQ against COVID-19 infection with comorbidities (HT, Diabetes) â?? Group3 <br/ ><br>age 18 -65 years (HCW who are actively on duty and not any who have retired) who are to be initiated on prophylaxis â?? Group 2 with comorbidities (HT, Diabetes) <br/ ><br>→ | Exclusion criteria: Health care workers who show symptoms suggestive of COVID-19 or are positive for COVID-19 <br/ ><br>Women of child bearing potential who are not willing for adequate contraception during the time of blood collection / who were not practicing adequate contraception in the last 28 days <br/ ><br>Women who are pregnant or breast feeding <br/ ><br>Participants who are not determined to be fit by the investigator <br/ ><br>Participants who are prescribed HCQ for any other indication / history of taking HCQ in the last one year <br/ ><br>→ | | Intervention1: Hydroxychloroquine sulphate: Oral tablet 400 mg twice a day on Day 1, followed by 400 mg once weekly for next 7 weeks to be taken with meals<br>Control Intervention1: Not applicable: Single arm study<br>→ | The modelling will help assess which of the variables including the presence of comorbidities (if any) would have the greatest impact on the drug concentrations in an Indian population. It would also help us understand if COVID-19 infection alters the pharmacokinetics of HCQ.Timepoint: 2-8 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/025243 | 27 January 2021 | A study on salivary samples and nasopharyngeal samples in diagnosis of COVID-19 Disease Patients | A prospective study to compare the reliability of salivary samples paired nasopharyngeal in COVID-19 Infection -An Indian study | | Medanta Institute of Education and Research | 19-05-2020 | 20200519 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43615 | Not Recruiting | No | | | | 19-05-2020 | 40 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Kuldeep K Chauhan→ | | Research Department , Room No-1, 10th Floor, Medanta The Medcity Hospital Gurgram Haryana India → | vikas.deswal@medanta.org→ | 9992837902→ | | Inclusion criteria: Adults above the age of 18 years, who give consent to collect saliva samples independently according to the CDC guidelines <br/ ><br>The IPD/OPD adults who are confirmed positive and negative for COVID-19 infection, by rRT-PCR of NP swabs done at NABL accredited laboratory.→ | Exclusion criteria: Patients who are on drugs affecting saliva production like anticholinergics. <br/ ><br> Patients who have xerostomia or any active oral disease or injury. <br/ ><br>Patients who are mechanically ventilated or critically ill. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To compare the sensitivity and specificity of paired salivary samples and nasopharyngeal samples in diagnosis of COVID-19 infectionTimepoint: Day 0,7 and 14→ | | | | Yes | False | | |
| → | CTRI/2020/05/025238 | 27 January 2021 | Emotional Impact of Isolation during COVID 19 among college students and staff | Emotional Impact and Resilience due to Isolation (EIRI) during COVID 19 among college students and staff- A a web based survey - EIRI during COVID 19 | | Veena Nayak | 19-05-2020 | 20200519 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43623 | Not Recruiting | No | | | | 20-05-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Veena Nayak→ | | Depertment of Pharmacology, Kasturba Medical College, Manipal → | veena.nayak@manipal.edu→ | 9844773573→ | KMC Manipal→ | Inclusion criteria: students and faculty of KMC Manipal→ | Exclusion criteria: Those who refuse to give consent→ | | | The outcome measures include scores on the three rating instruments, namely, Connor-Davidson Resilience Scale, Distress Tolerance Scale, and Mindful Attention Awareness ScaleTimepoint: Cross sectional one point response→ | | | | Yes | False | | |
| → | CTRI/2020/05/025272 | 27 January 2021 | A study to assess the efficacy of Homoeopathic medicine in the prevention of Covid-19
| Efficacy Of Homoeopathic Prophylactic Intervention On Covid-19 Pandemic-A Double Blind Randomised Controlled Trial
- HPCOV-19 | | Nil | 20-05-2020 | 20200520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43790 | Not Recruiting | No | | | | 30-05-2020 | 800 | Interventional | Cluster Randomized Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr S Balamani→ | | Government Homoeo Dispensary, Department Of Homoeopathy, Kandathpara,
Marutharoad.
→ | drppramod@yahoo.co.in→ | 9447240762→ | Department of Homoeopathy, Government of Kerala, Palakkad district→ | Inclusion criteria: 1) People who are under institutional (Covid-19 care centre) or home quarantine (in Palakkad district Kerala) related to Covid-19 after returning from other states or from abroad. <br/ ><br>2) People who are under institutional (Covid-19 care centre) or home quarantine (in Palakkad district Kerala) related to Covid-19 <br/ ><br>3) Adults aged 18 and above; Children aged 12 and above, with assent of parents. <br/ ><br>4) Primary contacts of Covid-19 positive cases <br/ ><br>5) Secondary contacts of Covid-19 positive cases <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1) All people who are not willing to take part in the study. <br/ ><br>2) People who are having Covid-19 symptomatology. <br/ ><br>3) People who are taking medications for liver or renal diseases. <br/ ><br>4) Children below 12 years. <br/ ><br>5) Critically ill patients. <br/ ><br>6) Pregnant ladies <br/ ><br>7) Persons on chemotherapy <br/ ><br>8) People under medication following Organ transplantation. <br/ ><br>9) Persons who are taking any other medicine for preventive purposes for Covid-19/ flu like illness <br/ ><br>10) RT PCR positive persons before the intervention. <br/ ><br>→ | | Intervention1: Arsenicum album 30: Arsenicum album 30 / <br>4 pills to be taken in the morning on empty stomach for three consecutive days.<br>Any oral intake is restricted for 30 minutes after this.<br>On the 30th, 31st and 32nd days of the first dose again 4 pills are to be taken in the morning on empty stomach.<br>Any oral intake is restricted for 30 minutes after this.<br><br><br><br>Control Intervention1: No.40 size Globules medicated with alcohol 90% v/v is used as Comparator agent(Placebo): Placebo / 4 pills to be taken in the morning on empty stomach for three consecutive days. Any oral intake is restricted for 30 minutes after this.<br>On the 30th, 31st and 32nd days of the first dose again 4 pills are to be taken in the morning on empty stomach. Any oral intake is restricted for 30 minutes after this. <br>→ | To assess in quarantined persons related to Covid-19 in Palakkad District <br/ ><br>1)the incidence of symptoms of flu like illness/Covid- 19 infection <br/ ><br>2)the relative risk of flu like illness/Covid-19 infection among persons under Homoeopathic prophylactic intervention when compared to the control population <br/ ><br> <br/ ><br>Timepoint: 28th and 56 th day <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/05/025254 | 27 January 2021 | To Study effectiveness and outcomes of Unani Medicine prophylactic interventions on population at risk of COVID-19 | Population based Prospective Study on effectiveness and outcomes of Unani Medicine prophylactic interventions on population at risk of COVID-19 | | Central Council for Research in Unani Medicine CCRUM New Delhi | 20-05-2020 | 20200520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43630 | Not Recruiting | No | | | | 29-05-2020 | 40000 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Pradeep Kumar→ | | Room No 516, 5th Floor
Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri → | ccrum507@rediffmail.com→ | 9213511298→ | Central Council for Research in Unani Medicine (CCRUM)→ | Inclusion criteria: 1. Individuals of either sex above 18 and below 68 years <br/ ><br>2. Population as described in High/Moderate/Low Risk <br/ ><br>3. Individuals who are from the identified containment zone/ quarantine facility with at least 1 confirmed COVID-19 positive case. <br/ ><br>4. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study→ | Exclusion criteria: 1. Persons with severe primary respiratory disease or related complications that may be identified with COVID-19 <br/ ><br>2. Laboratory confirmed COVID-19 with or without symptoms <br/ ><br>3. Pregnant and lactating mothers and those who have a pregnancy plan. <br/ ><br>4. Persons with serious critical illness, or severe mental illnesses <br/ ><br>5. Individuals with uncontrolled, unstable comorbidities <br/ ><br>6. Immunocompromised individuals or those on immunosuppressants and steroids <br/ ><br>7. Subjects having a past history of allergy to any medicine that is part of the Unani intervention.→ | | Intervention1: Unani Joshanda (Decoction)and Khameera Marwareed: Unani Joshanda (Decoction) lukewarm once daily in the evening and Khameera Marwareed 5g once daily in the morning for 20 days, for 10000 subjects. (Test group 1)<br>Intervention2: Unani Joshanda (Decoction)and<br>Tiryaq-e-Arba: Unani Joshanda (Decoction) lukewarm once daily in the evening,and Tiryaq e Arba 5g with lukewarm water in the morning for 20 days for 10000 patients. (Test group 1)<br>Control Intervention1: nil: nil<br>→ | Incidence of COVID-19 cases in control as well in interventional group <br/ ><br>2.Improvement in immune status using Immune Status Questionnaire (ISQ) <br/ ><br>Timepoint: 20days→ | | 14/08/2020 | | Yes | False | | |
| → | CTRI/2020/05/025276 | 27 January 2021 | effect of Ayurvedic intervention in COVID-19 positive cases | A Pilot study to estimate the effectiveness of Ayurvedic intervention in COVID-19 positive cases | | Ch Brahm Prakash Ayurved Charak Sansthan | 20-05-2020 | 20200520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43892 | Not Recruiting | No | | | | 29-05-2020 | 50 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Arun Gupta→ | | CBPACS, Khera Dabar, New Delhi 110073 Room no 142
Panchakarma Department
CBPACS
New Delhi 110073→ | arun24@hotmail.com→ | 9999155377→ | Chaudhary Brahm Prakash Ayurved Charak Sansthan→ | Inclusion criteria: 1. Willingness to participate in the study and provide the informed consent. <br/ ><br>2. Isolated asymptomatic cases that have been tested positive for SARS-CoV2 virus. <br/ ><br>→ | Exclusion criteria: 1. Cases presenting with severe symptoms of COVID-19. <br/ ><br>2. COVID-19 positive cases participating as subjects in the interventional arm of other COVID-19 clinical study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayurvedic medicines: 1. Sanshamani Vati <br>(Tinospora cordifolia) 1gm BD with 50ml Nagaradi kwath(Decoction of Zingiber officinale -2 part, Terminalia chebula- 4 part, Tinospora cordifolia-6 part in quantity)<br><br>2.Amalaki Churna <br>( Powder of Phyllanthus emblica)3gm with water<br>once a day at 5pm<br>3.Golden Milk (100ml of milk with 3gm of Curcuma longa) at 9pm. <br>Intervention2: Ayurveda Protocol: 1. Sanshamani Vati (Tinospora cordifolia) 1gm BD with 50ml Nagaradi kwath(Decoction of Zingiber officinale -2 part, Terminalia chebula- 4 part, Tinospora cordifolia-6 part in quantity) 2.Amalaki Churna ( Powder of Phyllanthus emblica)3gm with water once a day at 5pm 3.Golden Milk (100ml of milk with 3gm of Curcuma longa) at 9pm.<br>all to be taken orally <br>Duration 14 days<br>Control Intervention1: Not applicable: Not applicable<br>→ | 1. Time taken and number of patients progressing from asymptomatic to symptomatic condition. <br/ ><br> Timepoint: baseline <br/ ><br>Daily <br/ ><br>14 days→ | | 17/06/2020 | | Yes | False | | |
| → | CTRI/2020/05/025273 | 27 January 2021 | Impact of effect of Ayurvedic treatment on novel Corona virus disease | Impact of Indian traditional Ayurvedic treatment regime for nCoV-2 (COVID-19) | | Patanjali Research Institute | 20-05-2020 | 20200520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43900 | Not Recruiting | No | | | | 29-05-2020 | 120 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Abhishek Sharma→ | | Professor Department of Medicine
National Institute of Medical Sciences and Research, Jaipur
India 303121 NH 11 C Jaipur Delhi Highway Nims University Campus Jaipur Rajasthan India→ | dr.abhisheksharma1987@gmail.com→ | 9828816135→ | National Institute of Medical Sciences→ | Inclusion criteria: Asymptomatic patients <br/ ><br>Mildly symptomatic patients <br/ ><br>Moderately symptomatic patients <br/ ><br>Age 15-80 years of age <br/ ><br>Patients able to give Informed consent and follow instructions <br/ ><br>Agree to follow at 14 days and 30 days after testing positive for COVID-19→ | Exclusion criteria: Severely symptomatic patients (SaO2 <90%) <br/ ><br>Acute Respiratory Distress Syndrome (ARDS) <br/ ><br>Life expectancy less than 1 year due to other co-morbid conditions→ | Health Condition 1: J969- Respiratory failure, unspecified
→ | Intervention1: Ayurvedic Therapy: Tablet Pure Ashwagandha 500mg BD, Oral, After Breakfast / Dinner<br><br>Tablet Pure Giloy Extract 1000 mg BD, Oral, after Breakfast / Dinner<br><br>Tablet Pure Tulsi Extract 500 mg BD, Oral, after Breakfast/Dinner<br><br>Anu Taila 4 drops BD, Nasal Drop<br><br>Powder Swasari Ras 2 gm BD, Oral, Before Breakfast / Dinner<br>Control Intervention1: Placebo: Placebo Control of same dosage form<br>Control Intervention2: Placebo Therapy: Placebo of same dosage form by Oral / Nasal route<br>→ | Virological Clearance as measured by RT PCR of nasopharyngeal swabTimepoint: Baseline, 3 Days, 7 Days, 14 Days→ | | 14/06/2020 | | Yes | False | | |
| → | CTRI/2020/05/025275 | 27 January 2021 | Role of Chyawanprash in the prevention of COVID-19 in health care workers | Evaluation of protective potential of an Ayurvedic Rasayan (Chyawanprash) in the prevention of COVID-19 among Health Care Personnel â?? An open label, prospective Randomized controlled parallel group study | | CCRAS New Delhi | 20-05-2020 | 20200520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43917 | Not Recruiting | No | | | | 30-05-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Arun Gupta→ | | CBPACS, Khera Dabar, New Delhi 110073 Room no 142
Panchkarma Department
CBPACS,
Khera Dabar, New Delhi 110073→ | arun24@hotmail.com→ | 9999155377→ | Chaudhary Bahm Prakash Ayurved Charak Sansthan→ | Inclusion criteria: 1) All healthcare professionals and staff of age group between 25 to 60 years willing to participate, negative for SARS- Cov-2 at screening,(tested by rt-PCR) without co-morbid condition <br/ ><br>→ | Exclusion criteria: 1) Pregnant and lactating females. <br/ ><br>2) Immune compromised and co morbid condition cases. <br/ ><br>3)Laboratory confirmed COVID-19 with or without symptoms <br/ ><br>4)Known allergy to any of the medications used in this trial. <br/ ><br>5) Subjects who are taking any other medicine as prophylaxis such as HCQ. <br/ ><br>→ | | Intervention1: Ayurveda Rasayana along with conventional guidelines for health care workers.: Chyawanprash-12 g twice daily. <br>Dosage form : Avaleha (Jam like paste).<br>Route of Administration : Oral.<br>Time of Administration :Twice in a day- On empty stomach in the morning at least 1 hour before breakfast and at night two hours after dinner<br>Anupana : Warm water. <br>Duration of therapy : 1 month.<br><br>Control Intervention1: Conventional guidelines for health care workers as per the WHO.: Conventional guidelines for health care workers as per the WHO.<br>→ | Percentage of participants with SARS- Cov-2 positivity as estimated by RT-PCR of nasopharyngeal swabTimepoint: baseline <br/ ><br>Day 30→ | | 21/09/2020 | | Yes | False | | |
| → | CTRI/2020/05/025274 | 27 January 2021 | Impact of remote audio-visual surveillance of doffing process during COVID 19 pandemic on the safety of health care workers | Impact of remote audio-visual surveillance of doffing process during COVID 19 pandemic on the safety of health care workers: an observational study | | PGIMER Chandigarh | 20-05-2020 | 20200520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43921 | Not Recruiting | No | | | | 30-05-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | AJAY SINGH→ | | Dept ofAnaesthesia and Intensive care, Nehru hospital, PGIMER SECTOR 12 H.N.29
Sector 2A
Chandigarh 160011→ | ajay.ydv2509@gmail.com→ | 09999276845→ | PGIMER CHANDIGARH→ | Inclusion criteria: 1.Should have undergone training in the donning and doffing process at least once. <br/ ><br>2.A member of the staff working at the COVID unit in PGIMER. <br/ ><br>→ | Exclusion criteria: 1.The HCW who will be doffing for the first time. <br/ ><br>2.The HCW doffing due to an emergency (health issue of the HCW, or due to an observed damage in the PPE). <br/ ><br>3.Pregnant, breast feeding, history of joint replacements or other prosthetic devices, inflammatory skin conditions or having open wounds. <br/ ><br>4.Refuses to participate in the study. <br/ ><br>5.HCW who is involved in this study. <br/ ><br>→ | | | To study the incidence of error or breech in the safety during doffing process of health care workers by remote audio visual monitoring using camerasTimepoint: during the process of doffing→ | | | | Yes | False | | |
| → | CTRI/2020/05/025271 | 27 January 2021 | Clinical Trial of Mycobacterium w in COVID-19 Positive Patients, Hospitalized But Not Critically Ill | A Randomized, Double-blind, Two arm, controlled clinical trial to compare the Efficacy and Safety of Mycobacterium w (Mw) administered along with Standard of care versus Placebo administered along with Standard of care, in adult, COVID 19 positive patients hospitalized but not critically ill. | | Cadila Pharmaceuticals Limited | 20-05-2020 | 20200520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43206 | Recruiting | No | | | | 31-05-2020 | 480 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 3 | India→ | Dr Anil Avhad→ | | 1389, Trasad Road
Dholka, Ahmedabad 1389, Trasad Road
Dholka, Ahmedabad→ | anil.avhad@cadilapharma.co.in→ | | Cadila Pharmaceuticals Limited→ | Inclusion criteria: 1. COVID-19 positive patients with ordinal scale score of 3 with comorbid illness including diabetes mellitus, hypertension, chronic lung disease, immunocompromised status, active malignancy, chronic kidney disease, chronic liver disease, obesity (BMI >25Kg/m2), or subjects who have doubling of CRP compared to baseline or have Neutrophil-to-Lymphocyte Ratio â?¥3.5. <br/ ><br>2. Patients of either gender, age â?¥ 18 years at the time of enrollment. <br/ ><br>3. Female patients who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 3 months post-dosing. <br/ ><br>4. The patients must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.→ | Exclusion criteria: 1. Patient with ordinal scale of â?¥4 at the time of hospital admission and randomization. <br/ ><br>2. Pregnant and / or lactating female patients. <br/ ><br>3. A family history of congenital or hereditary immunodeficiency. <br/ ><br>4. Any disease condition requiring ICU admission. <br/ ><br>5. History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator. <br/ ><br>6. History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period. <br/ ><br>7. History of allergic reactions or anaphylaxis to Mw or its component. <br/ ><br>8. Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patientâ??s health or is likely to result in nonconformance to the protocol or a patientâ??s ability to give written informed consent.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Suspension of heat killed (autoclaved)Mycobacterium w: 0.3 ml (0.1ml x 3 Injection) of intradermal Mw for 3 consecutive days with Standard therapy of COVID-19<br>Control Intervention1: Placebo: 0.3 ml (0.1 ml x 3 Inj.) of intradermal Placebo for 3 consecutive days with Standard therapy of COVID-19<br>→ | Number of patients with increased disease severityTimepoint: From baseline to at any time during the study till 28 days post first dosing.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025248 | 27 January 2021 | COVID-19 telephonic counseling model for addressing mental health concerns in different populations during corona outbreak in India | Evaluation of the COVID-19 telephonic counseling model for addressing mental health concerns in different populations during corona outbreak in India: A hospital based study | | Dr Rahul Taneja | 20-05-2020 | 20200520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43479 | Not Recruiting | No | | | | 15-06-2020 | 128 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ansha Patel→ | | Dept of Psychiatry,
RNT Medical College, Udaipur → | ansha_patel@yahoo.co.in→ | 9742442438→ | Dept of Psychiatry, RNT Medical College, Udaipur→ | Inclusion criteria: All consenting individuals who undergo screening and attend corona screening clinic at MB Hospital and are willing to participate.→ | Exclusion criteria: Individuals who are not willing to participate. <br/ ><br>Special groups such as Children and pregnant women are excluded from participation as they have special needs and are counseled using specific WHO modules rather than a more generic one being followed in this study. <br/ ><br>Patients who are severely symptomatic with respiratory failure or on ventilator. <br/ ><br>Patients who are known cases with p/h/o of psychiatric illness (these will be ref to dept of psychiatry for individual case management) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Telecounseling for COVID 19: <br>The teleconsultation model is devised as per WHO COVID mental health model (2019) guidelines. <br><br>It proposes one to protect oneself, be informed from trusted sources, stay safe, be ready, find opportunities to amplify positive and hopeful stories and positive images of local people who have experienced COVID-19, honor and acknowledge carers and healthcare workers, be kind and support oneself as well as others (WHO,2020). <br><br><br>Intervention2: Brief telecounseling model for Coping with psychological concerns associated with COVID 19: The interventional model used in this study is structured as per WHO 2020 model of addressing mental health concerns due to COVID-19.<br><br>It has separate guidelines for addressing psychological concerns for quarantined/isolated HEALTHCARE WORKERS AND GENERAL POPULATION.<br><br>Briefly the module focuses cognitive,emotional, interpersonal and behavioral strategies to: <br><br>1. Prevent the spread, protect oneself & sig others, stay safe.<br><br>2. Be informed with reliable sources and assess risk.<br><br>3. Limit media exposure<br><br>4. Be ready and prepare for response to outbreak<br><br>5. Being kind and extending assistance to sig others.<br><br>6. Lifestyle balance & Self care<br><br>7. Enabling social supports to cope<br><br>8. Seeking mood enhancing/ positive experiences on a daily basis.<br><br>9. Measures for mind and body relaxation.<br><br>10.Building hope and amplifying images of people who have coped with COVID 19.<br><br>11. Avoid substance use/abuse â?? including tobacco, vaping and alcohol, Moderate caffeine intake<br><br>12. Stay active, schedule daily events, maintain/create family routines/ esp care for vulnerable groups.<br><br>13. Effective communication for any unmet needs, personal help and timely call for professional psychological help.<br><br>Control Intervention1: → | Primary outcome is Anxiety (assessed as a continuous variable on HADS).Timepoint: Pre and Post intervention ( 14 days)→ | | | | Yes | False | | |
| → | CTRI/2020/05/025247 | 27 January 2021 | To Study Clinical Characteristics, Treatment Outcome of Coronavirus (COVID-19) Patients | A PROSPECTIVE OBSERVATIONAL STUDY ON THE CLINICAL CHARACTERISTICS, DIAGNOSIS, TREATMENT AND OUTCOME OF NOVEL CORONAVIRUS DISEASE (COVID-19) - COVID-19 | | Dr Amit Patel | 20-05-2020 | 20200520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43762 | Not Recruiting | No | | | | 26-05-2020 | 500 | Observational | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Hardik Shah→ | | CIMS Hospital Pvt. Ltd.
Plot No. 67/1, Opp. Punchamrut Bunglows, Nr. Shukan Mall, Off Science City Road, Sola, Ahmedabad → | surabhi.madan@cimshospital.org→ | 9712971863→ | CIMS Hospital Pvt. Ltd.→ | Inclusion criteria: 1. 18 years or older <br/ ><br> <br/ ><br>2. All suspected COVID-19 hospitalized patient <br/ ><br>3. Willing and able to provide written informed <br/ ><br> consent prior to performing study procedures <br/ ><br>4. Has laboratory-non confirmed SARS-CoV-2 <br/ ><br> infection as determined by PCR or other <br/ ><br> commercial or public health assay but with <br/ ><br> typical signs including fever, cough, loss <br/ ><br> of test, sense of smell and headache etc. <br/ ><br>5. Illness of any duration, and at least one of <br/ ><br> the following: Radiographic infiltrates by <br/ ><br> imaging (chest x-ray, CT scan, etc.), or <br/ ><br> Clinical assessment (evidence of <br/ ><br> rales/crackles on exam) AND SpO2 â?¤ 94% on <br/ ><br> room air, or require mechanical ventilation <br/ ><br> and/or supplemental oxygen.→ | Exclusion criteria: 1. Participation in any other clinical trial of <br/ ><br> an experimental treatment for COVID-19 <br/ ><br> <br/ ><br>2. Immunocompromised patients taking medication <br/ ><br> upon screening <br/ ><br> <br/ ><br>3. Consideration by the investigator, for any <br/ ><br> reason, that the subject is an unsuitable <br/ ><br> candidate to receive study treatment <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | A. Clinical status of subject <br/ ><br>1. Hospitalized, not requiring supplemental oxygen; <br/ ><br>2. Hospitalized, requiring supplemental oxygen; <br/ ><br>3. Hospitalized, on non-invasive ventilation or high flow oxygen devices; <br/ ><br>4. Hospitalized, on invasive mechanical ventilation or ECMO; <br/ ><br>B. Clinical status of subject at discharge <br/ ><br>1. Hospitalized, not requiring supplemental oxygen; <br/ ><br>2. Hospitalized, requiring supplemental oxygen; <br/ ><br>3. Death; <br/ ><br>Timepoint: During Hospitalization Baseline to till Discharge→ | | | | Yes | False | | |
| → | CTRI/2020/05/025293 | 27 January 2021 | Difficulties faced by pregnant women during the Covid 19 Pandemic and lockdown | Challenges of pregnancy during the COVID 19 pandemic and lockdown | | Shri BM Patil Medical College Hospital and Research CenterBLDE Deemed to be University | 21-05-2020 | 20200521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43824 | Recruiting | No | | | | 27-05-2020 | 250 | Observational | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded | N/A | India→ | Rajasri G Yaliwal→ | | Room no.2, Department of OBG, BLDE(DU) Shri BM Patil Medical College, Solpur Road, Vijayapura
Karnataka
Bhagavati Hospital Ashram Road, Opp BLDE Engg. College, Vijayapura,
Karnataka→ | ryaliwal@bldedu.ac.in→ | 09845152240→ | Shri B.M Patil Medical College, Hospital and Research Centre, BLDE(DU) Vijayapura→ | Inclusion criteria: All pregnant women consenting for the study→ | Exclusion criteria: non consenting pregnant women <br/ ><br>women below 18 years and above 40 years→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To assess the number of pregnant women who could not avail Antenatal services during the lock down and pandemicTimepoint: baseline→ | | | | Yes | False | | |
| → | CTRI/2020/05/025289 | 27 January 2021 | An observational study on QT interval changes with Hydroxychloroquine used as prophylaxis in COVID exposure risk individuals | An observational study on Hydroxychloroquine used as prophylaxis for high COVID exposure risk individuals with special reference to QT interval | | P Vamsavardhana Reddy | 21-05-2020 | 20200521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43612 | Not Recruiting | No | | | | 15-06-2020 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | P Vamsavardhana Reddy→ | | Department of General Medicine VIMS & RC EPIP area Nallurhalli Whitefield P Vamsavardhana Reddy Assistant Professor Department of General Medicine VIMS & RC EPIP area Nallurhalli Whitefield 560066→ | vamsareddy4403@vimsmail.com→ | 9686316728→ | Vydehi Institute of Medical Sciences and Research Centre→ | Inclusion criteria: All High COVID exposure risk individuals aged above 18 years & weight > 35 kg consuming Hydroxychloroquine as prophylaxis for COVID-19→ | Exclusion criteria: Individuals not willing to participate in the study→ | | Intervention1: Nil: Nil<br>→ | Magnitude and frequency of QTc changes. <br/ ><br>Timepoint: At 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/025291 | 27 January 2021 | Corona virus in tears | â??A cross-sectional study to assess the presence of Severe acute respiratory syndrome coronavirus (SARS-CoV-2) in tears of moderate to severe COVID 19 patientsâ?? | | Maulana Azad Medical College | 21-05-2020 | 20200521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43654 | Not Recruiting | No | | | | 24-05-2020 | 70 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr RITU ARORA→ | | Room no. 55,
Guru Nanak Eye Center
Maulana Azad Medical College
Department of Ophthalmology
Maharaja Ranjit Singh Marg
New Delhi → | dr_rituarora@yahoo.com→ | 01123236931→ | Maulana Azad Medical College New Delhi 110002→ | Inclusion criteria: Patients willing to participate in the study, with moderate to severe illness due to COVID 19 as per guidelines of Ministry of health and family welfare→ | Exclusion criteria: Mild or asymptomatic COVID 19 patients→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | Proportion of positive results for SARS-CoV-2 RNA from tears will be compared with those from naso/oropharyngeal swabs.Timepoint: within 48 hours of collection of naso/oropharyngeal swab→ | | | | Yes | False | | |
| → | CTRI/2020/05/025297 | 27 January 2021 | Spectrum of injuries during COVID-19 Lock down at a major trauma centre in Central India | Spectrum of injuries during COVID-19 Lockdown at a major trauma cenre in Central India- A Retrospective observational study | | Abdul Haque M Quraishi | 21-05-2020 | 20200521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43911 | Not Recruiting | No | | | | 31-05-2020 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Abdul Haque M Quraishi→ | | Department of Surgery
2nd Floor OT F
Government Medical College
Nagpur Department of Surgery
2nd Floor OT F
Government Medical College
Nagpur→ | am_quraishi@hotmail.com→ | 9822234597→ | Government Medical College Nagpur→ | Inclusion criteria: Patients of All ages who have sustained trauma within one week of admission.→ | Exclusion criteria: patients of flame burns, drowning, hanging and asphyxiation→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: T07-T07- Injuries involving multiple body regions
→ | | volume of patients and the causes of injuryTimepoint: During lockdown for COVID-19 and before lockdown→ | | | | Yes | False | | |
| → | CTRI/2020/05/025290 | 27 January 2021 | Psychological distress among health care workers due to COVID-19 outbreak | Psychological distress among health care workers in India during COVID-19 outbreak: A Nationwide Survey | | Dr Gautam Sharma | 21-05-2020 | 20200521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43671 | Not Recruiting | No | | | | 31-05-2020 | 10000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Gautam Sharma→ | | Center for Integrative Medicine and Research.
Room No. 7004
Convergence Block, AIIMS → | drgautamsharma12@gmail.com→ | | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: All the Medical/Paramedical/Support staff working during COVID-19 pandemic and willing to participate in study.→ | Exclusion criteria: Participant infected with COVID -19 Infection. <br/ ><br>If one or more than one question is unanswered in section 4. <br/ ><br>→ | | Intervention1: Not Applicable: Not Applicable<br>→ | Psychological distress among health care workers during COVID-19 pandemic.Timepoint: Will be compile at end of the study.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025277 | 27 January 2021 | Clinical Trial of Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19 | A Randomized, Double-blind, Two arm, Placebo Controlled Clinical Trial to Evaluate the Efficacy and Safety of Mycobacterium w in preventing COVID-19 in subjects at risk of getting infected with COVID-19. | | Cadila Pharmaceuticals Limited | 21-05-2020 | 20200521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43176 | Recruiting | No | | | | 31-05-2020 | 4000 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 3 | India→ | Dr Anil Avhad→ | | 1389, Trasad Road
Dholka, Ahmedabad 1389, Trasad Road
Dholka, Ahmedabad→ | anil.avhad@cadilapharma.co.in→ | | Cadila Pharmaceuticals Limited→ | Inclusion criteria: 1.Healthy subjects with recent history of close contact with COVID-19 patients. <br/ ><br>2.Subjects with SARS Cov 2 negative test (ICMR approved test kit) at screening visit. <br/ ><br>3.Subject of either gender, age â?¥ 18 years at the time of enrollment. <br/ ><br>4.Female subject who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 3 months post-dosing. <br/ ><br>5.The subject must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form.→ | Exclusion criteria: 1.Any febrile illness with oral temperature > 100°F within 3 days prior to randomization. <br/ ><br>2.Subject with past history of COVID-19 infection. <br/ ><br>3.Pregnant and / or lactating female subjects. <br/ ><br>4.Presence of any illness requiring hospital referral. <br/ ><br>5.Any confirmed or suspected immune-deficient condition based on medical history and physical examination and a family history of congenital or hereditary immunodeficiency or Individuals on immunosuppressantâ??s as Azathioprine, Cyclosporine, Mycophenolate etc. <br/ ><br>6.History of allergic reactions or anaphylaxis to Mw or its component.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Suspension of heat killed (autoclaved)Mycobacterium w: 0.2 ml (0.1 ml x 2 Inj.) of intradermal Mw on day 0 and<br>0.1 ml of intradermal Mw on day 15<br>Control Intervention1: Placebo: 0.2 ml (0.1 ml x 2 Inj.) of intradermal Placebo on day 0 and 0.1 ml of intradermal Placebo on day 15<br>→ | No. of subjects acquiring COVID-19 infectionTimepoint: From first dosing till 8 week post first dosing.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025299 | 27 January 2021 | Convalescent Plasma treatment trial in COVID 19 patients | Convalescent Plasma to Limit Coronavirus Associated Complications: An Open label Clinical Study of Anti-SARS-CoV-2 Plasma in Hospitalized Patients with COVID-19 | | Wockhardt Ltd | 21-05-2020 | 20200521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43752 | Not Recruiting | No | | | | 01-06-2020 | 20 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 2 | India→ | Dr AjayKumar R Yadav→ | | Wockhardt Towers
Bandra Kurla Complex → | abhatia@wockhardt.com→ | 02226534444→ | Wockhardt Limited→ | Inclusion criteria: 1.Male or female, aged between 18 to 75 years (both inclusive) <br/ ><br>2.Hospitalized with RT-PCR confirmed COVID-19 illness and has any one of the below mentioned two: <br/ ><br>PaO2/ FiO2 <300 <br/ ><br>Respiratory Rate > 24/min and SaO2 < 93% on room air <br/ ><br>3.Subject or LAR agree to provide a signed written informed consent prior to any study specific procedures and also agree to comply with study requirements <br/ ><br>→ | Exclusion criteria: Exclusion Criteria: <br/ ><br>1.Receipt of pooled immunoglobulin in past 30 days <br/ ><br>2.Contraindication to transfusion or history of prior reactions to transfusion blood products <br/ ><br>3.Critically ill patients: <br/ ><br>PaO2/ FiO2 ratio <200 (moderate - severe ARDS) <br/ ><br>Shock <br/ ><br> <br/ ><br>4.Participating in any other clinical trial <br/ ><br>5.Clinical status precluding infusion of blood products <br/ ><br> <br/ ><br>6.Female subjects with positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Convalescent Plasma: SARS-CoV-2 convalescent plasma (single unit; additional unit will be given only if required based on subjectâ??s clinical status)<br>Control Intervention1: COVID Standard treatment: As per Revised Guidelines on ClinicalManagement of COVID â?? 19; Government of India<br>Ministry of Health & Family Welfare<br>Directorate General of Health Services<br>(EMR Division);31st March 2020<br>→ | Avoidance of progression to severe ARDSTimepoint: day 28→ | | 28/08/2020 | | Yes | False | | |
| → | CTRI/2020/05/025298 | 27 January 2021 | Siddha Intervention Population Study. | A prospective non-randomised open label controlled interventional study on
the e ffe ct of Siddha intervention as a prophylactic measure among high risk
population (Health Care Workers/
Containment Zone population) exposed to COVID 19 | | Central council for research in Siddha | 21-05-2020 | 20200521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43761 | Not Recruiting | No | | | | 25-05-2020 | 21500 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrKKanakavalli→ | | Anna Hospital Campus Arumbakkam → | drkkanakavalli@gmail.com→ | | siddha central research Institute→ | Inclusion criteria: 1. Adult Male or Female subjects above the age of 5 years to 68 years <br/ ><br>2. Subjects who are from a community where at least 1 confirmed case is already identified. <br/ ><br>3. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br>→ | Exclusion criteria: Pregnant and Lactating females <br/ ><br>Known cases of uncontrolled Diabetes and Hypertension COPD or Lung related diseases <br/ ><br>Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4. Subjects having immune compromised status like HIV Hepatitis Tuberculosis Cancer etc. <br/ ><br>5. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>7. Subjects having a past history of allergy to any medicine that is part of the Siddha intervention. <br/ ><br>8. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in and completion of the protocol <br/ ><br>→ | | Intervention1: Kabasurakudineer<br><br>Nilavembukudineer: Siddha official formulation once daily for 14 days.<br>Control Intervention1: Personal Sanitation and Environmental Sanitataion: Sanitisers Handwash Masks Gloves for 6 months<br>→ | 1. Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic CareTimepoint: 1stweek 2ndweek 3rd week and 4th week→ | | | | Yes | False | | |
| → | CTRI/2020/05/025320 | 27 January 2021 | Effect of Yoga & Naturopathy in patients with COVID-19 | NATUROPATHY AND YOGA IN THE MANAGEMENT OF COVID19
A Multi-center controlled clinical trial - YONAC Trial | | Government Yoga And Naturopathy Medical College Chennai | 22-05-2020 | 20200522 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43576 | Recruiting | No | | | | 22-05-2020 | 658 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | Manavalan Narayanaswamy→ | | Department of Naturopathy, Government Yoga & Naturopathy Medical College, Arignar Anna Indian Medicine Campus, Arumbakkam, Chennai → | gynmcchennai@gmail.com→ | | Government Yoga AND Naturopathy Medical College→ | Inclusion criteria: a) Written informed consent prior to performing study procedures. Witnessed oral consent will be accepted in order to avoid paper handling. Written consent by patient or their family members will be obtained wherever applicable. <br/ ><br>b) Male or Female adult patient â?¥18 years and â?¤75 years of age at the time of recruitment <br/ ><br>c) Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR in naso/oropharyngeal swabs or any other relevant specimen <br/ ><br>d) Asymptomatic / uncomplicated illness / mild pneumonia COVID-19 as defined by ICMR <br/ ><br>→ | Exclusion criteria: a) Explicit non-willingness to be a part of the research study <br/ ><br>b) Patients with moderate/severe stages of COVID19 <br/ ><br>c) Participation in any other clinical trials <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Yoga & Naturopathy immune boostinng and stress management protocol: Essential: <br>1. Natural immune boosting fresh juice: Indian Gooseberry juice â?? 50ml<br>Basil Juice â?? 50ml<br>Ginger Juice â?? 10ml<br>Fresh Lime juice â?? 5ml<br>Turmeric powder â?? ¼ tsp<br>Water â?? 150 ml<br> (Morning)<br>2. Natural immune boosting hot drink: Peeled Crushed Ginger 5 gm,<br>Tulsi (Basil) leaves 10 gms,<br>Pepper powder ¼ tsp,<br>Crushed Adhimaduram 5 gms (liquorice root),<br>Turmeric powder ¼ tsp and drinking water 250 ml<br>(Evening).<br>3. Yoga: Vajrasana, Bhastrika, Brahmari, Quick relaxation technique, Deep relaxation technique, Jala Neti (twice/thrice a day)<br>Care as indicated by Y&N physician<br>1. Hot water gargling: Taking 30-50 ml of water and whirl it around pharynx & oral cavity. <br>2. Steam inhalation: Inhalation of steam with or without essential oils for 5-10 minutes.<br>3. Sun bath: Sun exposure (10 minutes) in the morning and in the evening<br>4. Aromatherapy (Eucalyptus/peppermint/thyme/lavendar/basil): 1-2 drops in tissue paper or mix with gingely oil & apply over nose and neck. <br>These treatments will be given from enrollment till 14 days post-confirmation of infection<br>Control Intervention1: Standard Care: Standard care as per local protocol<br>→ | Time to progress to next stage of severity i.e., from asymptomatic/uncomplicated/mild pneumonia to moderate/severe stagesTimepoint: At 15 days→ | | | | Yes | False | | |
| → | CTRI/2020/05/025317 | 27 January 2021 | SURVEY OF MOUTH-DISSOLVING TURMERIC LOZENGES IN HEALTHCARE WORKERS | ASSESSMENT OF CLINICAL ACCEPTABILITY OF MOUTH-DISSOLVING TURMERIC LOZENGES IN HEALTHCARE WORKERS INVOLVED IN COVID-19 | | Ms Gelnova Laboratories India Pvt Ltd | 22-05-2020 | 20200522 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43754 | Not Recruiting | No | | | | 26-05-2020 | 300 | PMS | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Post Marketing Surveillance | India→ | DR MANJUSHA RAJARSHI→ | | Summit plot 11 flat 2
Amritvan complex
Goregaon Summit plot 11 flat 2
Amritvan complex
Goregaon→ | manjusharajarshi@gmail.com→ | 9820315688→ | Consultant, Gelnova Labs India Pvt Ltd.→ | Inclusion criteria: Healthcare professionals and paramedic staff serving COVD-19 will be enrolled in the study. <br/ ><br> <br/ ><br>Inclusion criteria: <br/ ><br> <br/ ><br>a. All adult individuals of both sexes working in COVID-19 wards. <br/ ><br>b. Individuals willing to give informed consent <br/ ><br>c. Individuals with no prior history of COVID-19 infections <br/ ><br>d. Individuals currently not showing any symptoms of COVID-19 at the time of recruitment <br/ ><br>e. Individuals with no history and / or currently ongoing serious chronic health condition <br/ ><br>f. Willing to follow the protective majors as advised <br/ ><br>g. Willing to comply with the study protocol <br/ ><br> <br/ ><br>→ | Exclusion criteria: a. Any history of allergy to turmeric and /or any of the ingredients used in making of the lozenge. <br/ ><br>b. Refusal for informed consent. <br/ ><br>c. Concurrent ongoing other infections. <br/ ><br>d. Any current medical history that investigator may consider not advisable to work in COVID-19 ward. <br/ ><br>→ | | Intervention1: TURMGEL MOUTH DISSOLVING LOZENGE 100 MG: EACH SOFT GELATINE LOZENGE CONTAINS TURMERIC EXTRACT 100 MG<br><br>3 LOZENGES DAILY FOR 1 MONTH. <br>SUCK SLOWLY; DO NOT CHEW<br>Control Intervention1: Not applicable: Not applicable<br>→ | Clinical acceptability of turmeric lozenges in COVID-19 healthcare teamsTimepoint: DAY 15 (follow up 1) and DAY 30 (end of study) are evaluation time points.→ | | 09/07/2020 | | Yes | False | | |
| → | CTRI/2020/05/025319 | 27 January 2021 | Trial of antihypertensive losartan for additional benefit in treating COVID 19 infection. | Angiotensin Receptor Blocker Losartan for prevention of COVID 19 complications: a randomized placebo controlled trial - LICCI | | Sanjay gandhi Post Graduate Institute of Medical Sciences | 22-05-2020 | 20200522 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42751 | Recruiting | No | | | | 01-06-2020 | 186 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Dr Able Lawrence→ | | Department of clinical immunology & rheumatology,
C- Blockm 2nd Floor,
SGPGIMS, Rae Bareilly Road → | abledoc@gmail.com→ | 05222494385→ | | Inclusion criteria: 1. Age > 18 years <br/ ><br>2. Requirement of hospitalization <br/ ><br>3. Randomization within 24 hours of initial presentation to a hospital/diagnosis→ | Exclusion criteria: 1. Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin receptor blocker (ARB) <br/ ><br>2. Prior reaction or intolerance to an ARB or ACEi <br/ ><br>3. Blood pressure less than 100/70 mmHg <br/ ><br>4. Potassium great than 5.0 mEq/L <br/ ><br>5. Pregnancy or breastfeeding In females of childbearing age, unwillingness to use birth control for the duration of the study <br/ ><br>6. Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 <br/ ><br>7. AST and/or ALT > 3 times the upper limit of normal <br/ ><br>8. Severe volume depletion or severe acute kidney injury that, in the opinion of the investigator, would preclude administration of Losartan <br/ ><br>9. Concurrent treatment <br/ ><br>10. Inability to obtain informed consent <br/ ><br>11. Pregnancy→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Losartan: Losartan 25mg given twice a day till discharge or outcome.<br>Control Intervention1: Placebo: Given twice a day in same schedule as intervention till discharge or outcome<br>→ | Percentage of patient with treatment failure: <br/ ><br> <br/ ><br>Treatment failure defined as any of following after 48 hours of randomization <br/ ><br> i) A Fall in 1 score in Respiratory SOFA score <br/ ><br> ii) New requirement of respiratory assist devices (HFNC, NIV) <br/ ><br> iii) New requirement of mechanical ventilation <br/ ><br> iv) MortalityTimepoint: Percentage of patient with treatment failure: <br/ ><br> <br/ ><br>Treatment failure defined as any of following after 48 hours of randomization <br/ ><br> i) A Fall in 1 score in Respiratory SOFA score <br/ ><br> ii) New requirement of respiratory assist devices (HFNC, NIV) <br/ ><br> iii) New requirement of mechanical ventilation <br/ ><br> iv) Mortality→ | | | | Yes | False | | |
| → | CTRI/2020/05/025331 | 27 January 2021 | Home based prehabilitation via telemedicine in lung cancer patients during COVID 19 | To study the effectiveness of home based prehabilitation via telemedicine in Non-small cell lung cancer (NSCLC) patients awaiting surgery during COVID-19 pandemic | | AIIMS NEW DELHI | 23-05-2020 | 20200523 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43339 | Not Recruiting | No | | | | 24-05-2020 | 15 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Seema Mishra→ | | Department of oncoanaesthesia and Pallliative Medicine
Room no 249, 2nd floor
BRA IRCH, AIIMS NEW DELHI → | seemamishra2003@gmail.com→ | 29575225→ | Dr BRAIRCH, AIIMS→ | Inclusion criteria: 1. Age 20-65 years of both sexes with non-small cell lung cancer awaiting surgery2. Patients who have agreed to participate in the study after a teleconsultation. <br/ ><br>3. ASA I & II patients registered at DRBRAIRCH AIIMS, New Delhi <br/ ><br>→ | Exclusion criteria: . Patients who have underlying uncontrolled cardiac co morbidity at baseline will be excluded→ | Health Condition 1: C34- Malignant neoplasm of bronchus andlung
→ | Intervention1: Home based prehabilitation: prehabilitaion will include exercise plan, nutrition advice and psycological advice will be provided to all patients for 3 weeks<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | change in emotional functioning by DASS 21, physical functioning by change in performance score (Karnofsky Performance Scale) score and change in respiratory functional parameters from baseline to 3 weeks of home based prehabilitationTimepoint: at Baseline and 3 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/025327 | 27 January 2021 | To study some blood tests which would help predict severity and outcome in children with cancers having the novel corona virus infection. | Understanding the biochemical and immunological correlates of severity and outcomes of COVID-19 in children with cancer undergoing chemotherapy | | NO SPONSOR | 23-05-2020 | 20200523 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43914 | Not Recruiting | No | | | | 09-06-2020 | 60 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Deepthi Boddu→ | | Department of Pediatrics
Unit 1
cHRISTIAN Medical College Vellore , Tamil Nadu
India → | drdeepthiboddu@gmail.com→ | 8056321856→ | Christian Medical College Vellore→ | Inclusion criteria: All children with cancer who are undergoing treatment under Pediatric Haematology and Oncology will be included.→ | Exclusion criteria: Patients who do not give consent to be included→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: D499- Neoplasm of unspecified behavior of unspecified site
→ | | For every child with febrile illness, the following outcomes will be measured: (1) clinical outcomes of infections (if any) including severity (pneumonia, multi-organ failure, death) and time to recover.Timepoint: Outcomes will be measured at baseline, week1, week2, week3 and at week4. Antibody response will be measured at week 4 and at 3 months.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025332 | 27 January 2021 | Ashwagandha for prevention against SARS-CoV-2 Infection: A Randomized Hydroxychloroquine Controlled drug trial in high risk Health Care Providers | Ashwagandha for the Prophylaxis against SARS-CoV-2 Infection: A Randomized Hydroxychloroquine Controlled Clinical Trial in Health Care Providers | | MINISTRY OF AYUSH | 23-05-2020 | 20200523 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43665 | Recruiting | No | | | | 28-05-2020 | 400 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | DR ARVIND CHOPRA→ | | 11 HERMES ELEGANCE
1988 CONVENT STREET
CAMP PUNE 11 HERMES ELEGANCE
1988 CONVENT STREET
CAMP PUNE 411001
MAHARASHTRA→ | crdp5624@gmail.com→ | 91-20-26344099→ | CENTER FOR RHEUMATIC DISEASES→ | Inclusion criteria: 1.Participants of either sex, 20 to 69 years of age <br/ ><br>2.Participants tested negative for COVID-19 by nose and throat swab using RT PCR technique <br/ ><br>3.HCQ naïve participants <br/ ><br>4.Willing to come for regular follow â?? up visits <br/ ><br>5.Written Informed Consent <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1.Participants with hypersensitivity or Intolerance and contraindications (psoriasis, porphyria and Glucose-6-Phosphate Dehydrogenase deficiency) <br/ ><br>2.Pregnant women, lactating women and women of child bearing potential not willing to follow adequate contraception <br/ ><br>3.Participants with known allergy or contraindication to Ashwagandha <br/ ><br>4 Have any Chronic,Severe,Unstable,Uncontrolled medical disease such as Diabetes Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the participant at increased risk during the study <br/ ><br>5.History of having received any investigational drug in the preceding one month. <br/ ><br>6.Prolonged concurrent intake of any drug that is known to prolong QT interval on the ECG as per physician discretion and these drugs include anti-arrhythmic drugs, quinidine, chlorpromazine, haloperidol, olanzapine, thioridazine, fluoxetine, antibiotics belonging to quinolone and macrolide family, antibiotics, fenfluramine and other appetite suppressants, Beta-2 agonists, terfenadine and other anti- histaminic drugs, liquorice and potassium loweringdrugs <br/ ><br>7.History of taking any kind of Ayurvedic formulation or any other form of CAM (Complementary Alternative Medicine) therapy in the preceding 2 months <br/ ><br>8.Unwilling to come for regular follow-up for the entire duration of the study. <br/ ><br>9.Non â?? co-operative attitude of the participant <br/ ><br>10.Any condition that, in the opinion of the investigator, does not justify the participantâ??s inclusion in the study. <br/ ><br>Liver enzymes > 1.5 times of upper normal limits, Serum creatinine > 2 mg/dL, Blood urea > 70 mg/dL <br/ ><br>→ | | Intervention1: Ashwagandha (Withania somnifera: Ashwagandha has immunomodulant and immune enhancing activity. It is anti oxidant and promotes health<br>250 mg, 2 tablets twice a day for 12 weeks<br>Control Intervention1: Hydroxychloroquine: HCQ is considered to be anti viral and anti inflammatory.<br>400 mg tablet.<br>400 mg tablet twice a day on Day 1, 400 mg once a week for 7 weeks<br>→ | (i)Proportion of SARS-CoV-2 infection free participants on completion of study <br/ ><br>(ii)Proportion of participants contracting COVID-19 during the study period <br/ ><br>Timepoint: WEEK 12→ | | | | Yes | False | | |
| → | CTRI/2020/05/025326 | 27 January 2021 | Tablet PINAK given as treatment to COVID positive patients. | Ayurvedic proprietary adjuvant oral intervention Tab PINAK for COVID
patients towards early recovery. | | Shree Bharadi Ayurvedic | 23-05-2020 | 20200523 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43951 | Not Recruiting | No | | | | 31-05-2020 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Pandurang Pawar→ | | 207 I Shaniwar Peth Shahu Chowk Karad 415110 → | drpandurangpawar@gmail.com→ | 8830207186→ | Shree Bharadi Ayurvedic Pharamaceuticals→ | Inclusion criteria: Patients reporting positive for COVID infection in COVID wsrd of SKNMC and GH Pune→ | Exclusion criteria: Below 18 years of age, Pregnant and lactating women; Patients in ICU under ventilator.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | Intervention1: Tab PINAK: Moderate to severe disease: 2 Stat; plus 1 QID x 5 days: Mild: 1 TDS X 5 days. If required to be continued: maximum 14 days intervention<br>Control Intervention1: Not Applicable: Not applicable<br>→ | Early recovery and reduced mortalityTimepoint: Day 15→ | | 17/09/2020 | | Yes | False | | |
| → | CTRI/2020/05/025328 | 27 January 2021 | Study to Assess the Safety and Efficacy of Convalescent Plasma on outcome of COVID-19 Associated Complications | To Assess the Safety and Efficacy of Convalescent Plasma on outcome of COVID-19 Associated Complications - COVID PLASMA STUDY | | Apollo Hospitals Enterprise Limited | 23-05-2020 | 20200523 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43703 | Not Recruiting | No | | | | 01-06-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Rajesh Chawla→ | | Indraprastha Apollo Hospitals
Department of Respiratory & Critical Care Medicine
Room no. 1223
Sarita Vihar
Delhi Mathura Road
New Delhi 110 076
India
→ | drchawla@hotmail.com→ | 011-29871681→ | Indraprastha Apollo Hospitals→ | Inclusion criteria: 1. Tested positive for COVID 19 by RT-PCR <br/ ><br>2. Age > 18 years <br/ ><br>3. Written and informed consent <br/ ><br>4. Severe or Life threatening disease. <br/ ><br> <br/ ><br>1. Severe disease is defined as: (one or more are present) <br/ ><br>i. Dyspnea with oxygen saturation â?¤ 93%, <br/ ><br>ii. Respiratory frequency â?¥ 30/min and oxygen saturation â?¤ 93%, <br/ ><br>iii.Partial pressure of arterial oxygen to fraction of inspired oxygen ratio < 300 <br/ ><br>iv.Infiltrates on chest X-ray > 50% within 24 to 48 hours <br/ ><br> <br/ ><br>2. Life-threatening disease is defined as: (one or more are present) <br/ ><br> <br/ ><br>i. Respiratory failure needing invasive support <br/ ><br>ii. Sepsis, <br/ ><br>iii. Multiple organ dysfunction or failure <br/ ><br>→ | Exclusion criteria: 1. Known hypersensitivity to blood products <br/ ><br>2. Receipt of Pooled Immunoglobulin in last 30 days <br/ ><br>3. Participating in any other clinical trial <br/ ><br>4. Contraindications to blood products <br/ ><br>5. Pregnant or Breast feeding women <br/ ><br>6. In the opinion of the site investigator or primary clinical care team, anticipated to die within 48 hours. <br/ ><br>7.On mechanical ventilation for more than 7 days <br/ ><br>8.Acute or chronic disease/illness that, in the opinion of the site investigator, has an expected life expectancy of less than 28 days unrelated to COVID-19 induced pneumonia (e.g. stage IV malignancy, neurodegenerative disease, anoxic brain injury, etc.) <br/ ><br>9. Respiratory failure caused by illness other than SARS-CoV-2. <br/ ><br>10 . Other documented uncontrolled infection <br/ ><br>11. Severe DIC,TTP, or antithrombin III deficiency needing factor replacement, FFP, cryoprecipitate. <br/ ><br>12. Active intracranial bleeding. <br/ ><br>13. Clinically significant myocardial ischemia. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Convalescent plasma: Convalescent plasma, two doses of 200 mL each.<br>Control Intervention1: Routine standard of care treatment for COVID 19 disease: Routine standard of care treatment for COVID 19 disease<br>→ | The primary outcome is a composite measure of the <br/ ><br> <br/ ><br>i. All-cause Mortality at 28 days <br/ ><br>ii. Improvement of SOFA score Post transfusion <br/ ><br> <br/ ><br>Timepoint: 28 days from intervention→ | | | | Yes | False | | |
| → | CTRI/2020/05/025338 | 27 January 2021 | Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush -64) in the management of COVID-19 infection (Asymptomatic &Mild to Moderate symptoms | Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush -64) in the management of COVID-19 infection (Asymptomatic &Mild to Moderate symptoms)- An open label single arm prospective clinical trial | | Central Council For Research in Ayurvedic Sciences | 24-05-2020 | 20200524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44033 | Not Recruiting | No | | | | 02-06-2020 | 40 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Dr Shivshankar Rajput→ | | IPD Building First Floor
Central Ayurved Research Institute for cardiovascular Diseases, Road No. 66 Punjabi bagh west , New Delhi → | drbabitayadav@gmail.com→ | 9910171143→ | CCRAS→ | Inclusion criteria: 1.Mild to moderate cases registered in Ayurved and Unani Tibbia College and Hospital Designated as COVID Health Center above the age of 18 years, with COVID 2019 (Confirmed by RT-PCR) quarantined at identified hospital setup. <br/ ><br>2.Participants who can take medicines orally <br/ ><br>3.Patients willing to provide signed informed consent→ | Exclusion criteria: 1.Cases of severe vomiting which would make oral administration of medicine difficult. <br/ ><br>2.Cases of respiratory failure and requiring mechanical ventilation. <br/ ><br>3.Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 2 times the upper limit of normal. <br/ ><br>4.Patients with COVID 19 in critical condition or ARDS or NIAD 8 â??point ordinal score 2 Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation <br/ ><br>5.Pregnant or lactating women <br/ ><br>6.Any other condition, which as per the investigator would jeopardize the outcome of the trial.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayush 64: Dose: 2 capsules (500 mg each) thrice daily (2-2-2)<br>Dosage form: Tablets <br>Route of Administration: Oral<br>Time of Administration: Thrice a day after food<br>Anupana: Warm Water <br>Duration of therapy: 14 days<br><br>Control Intervention1: Not applicable: Not applicable<br>→ | a) Mean time (days) for clinical recovery as per clinical recovery criteria defined below. <br/ ><br>b) Number of patients showing â??clinical recoveryâ??. <br/ ><br>Timepoint: a) Mean time (days) for clinical recovery as per clinical recovery criteria defined below. [Time frame: Daily] <br/ ><br>b) Number of patients showing â??clinical recoveryâ??. [Time frame: Daily]→ | | 01/09/2020 | | Yes | False | | |
| → | CTRI/2020/05/025342 | 27 January 2021 | mask use in covid in medical personnel - a survey | Use of Mask in COVID-19 Epidemic among Healthcare Workers - A Questionnaire-Based Survey | | AIIMS | 24-05-2020 | 20200524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44039 | Not Recruiting | No | | | | 15-06-2020 | 500 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Heena Garg→ | | Department of Anaesthesiology,Pain Medicine and Critical Care, All India Institute of Medical Sciences (AIIMS), New Delhi Ansari nagar→ | gargheena11@gmail.com→ | 9464533877→ | AIIMS→ | Inclusion criteria: Health care workers practising in India in government or private hospitals. medical students working in hospitals→ | Exclusion criteria: health care workers practising outside INDIA or currently not working→ | | Control Intervention1: NIL: NIL<br>→ | To assess the awareness about the use of mask and its disposalTimepoint: 1 month→ | | | | Yes | False | | |
| → | CTRI/2020/05/025336 | 27 January 2021 | Randomized Controlled Trial Of Resveretrol-Copper Or Sodium-Copper-Chlorophyllin Vs Standard Treatment In Mild Covid-19 infection | A Phase-III, Open Label, Randomized Controlled Trial Of Resveretrol-Copper Plus Standard Treatment Or Sodium-Copper-Chlorophyllin Plus Standard Treatment Versus Standard Treatment In Asymptomatic Or Mildly Symptomatic Patients With SARS-CoV-2 Infection (Covid-19) | | Tata Memorial Centre | 24-05-2020 | 20200524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43934 | Not Recruiting | No | | | | 01-06-2020 | 300 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3 | India→ | Vikram Gota→ | | Department of Clinical Pharmacology
ACTREC, Tata Memorial Centre
Sector-22, Kharghar, Navi Mumbai → | vikramgota@gmail.com→ | 7715019117→ | Advanced Centre for Treatment, Research and Education in Cancer , Tata Memorial Centre→ | Inclusion criteria: 1 Male and Non-pregnant Female <br/ ><br>2 Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen <br/ ><br>3 Either asymptomatic or have only mild symptoms ((cough and/or fever and/or sore throat and/or other upper respiratory symptoms) at the time of study inclusion <br/ ><br>4 Oxygen saturation of >94% while breathing ambient air, if this is measured <br/ ><br>5 Either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. <br/ ><br>6 Patients with high blood sugar or glycosylated haemoglobin, of any degree <br/ ><br>7 Arterial blood gas, if done, should have normal values of pH, PO2, PCO2 and bicarbonate levels <br/ ><br>→ | Exclusion criteria: 1 Have pneumonia confirmed by chest imaging, OR <br/ ><br>2 Have oxygen saturation (Sao2) of 94% or less while they were breathing ambient air <br/ ><br>3 Have any Grade 2 or worse laboratory abnormality, including haematological, renal, liver, electrolyes.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Resveratrol-Copper tablets: Patients will receive Resveratrol-Copper tablets (1 tablet 4 times per day) from the date of randomization to the day of discharge or death, whichever is earlier. Patients in this arm can also receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs.<br>Intervention2: Chlorophyllin tablets: Patients will receive oral Chlorophyllin tablets daily under fasting conditions at a dose of 750 mg OD from the date of randomization to the day of discharge or death, whichever is earlier. Patients in this arm can also receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs.<br>Control Intervention1: Standard treatment: Patients in this arm can receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs. However, patients in this arm cannot receive Resveratrol -Copper treatment.<br>→ | Proportion of patients who suffer clinical deterioration OR viral <br/ ><br>persistence at Day 10 from the date of randomization (excluding the date of randomization) <br/ ><br>Clinical deterioration will be defined as defined as a 2-point or greater deterioration on a 7-point ordinal scale in every patient measured on each day, until Day 10 from the date of randomization.Timepoint: Day 10→ | | | | Yes | False | | |
| → | CTRI/2020/05/025334 | 27 January 2021 | Protect and prevent onset of COVID like infections in Health Care Workers and High risk person. | Prophylactic intervention of Ayurvedic proprietary formulation and Whole
Colostrum given together, to prevent infection, morbidity, mortality in Healthcare
staff, doctors assigned to COVID Wards in SKNMC & GH, Narhe, Pune - SR4COVID | | Health Solutions | 24-05-2020 | 20200524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43935 | Not Recruiting | No | | | | 30-05-2020 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Sujata Vaidya→ | | B 902
Teerth Towers
Baner Annex
Pune → | drsujatavaidya@gmail.com→ | 9822311565→ | Health Solutions→ | Inclusion criteria: Health Care Staff, COVID workers and Doctors attending COVID ward at SKNMC & GH, Narhe, Pune→ | Exclusion criteria: Below age 18; <br/ ><br>Pregnant and Lactation women <br/ ><br>Persons admitted in Hospitals in ICU→ | | Intervention1: Ayurvedic SUVED; REIMMUGEN colostrum: Oral, additional, <br>Ayurvedic medicaments given for 30 days.<br>SUVED capsules. 1 BD, <br>Reimmugen 1 BD<br>with water before meals.<br>Control Intervention1: No comparative intervention: none being given<br>→ | Prevention of Onset or complications of COVID infectionTimepoint: Day 7 and day 30 after intervention.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025337 | 27 January 2021 | Randomized Controlled Trial Of Resveretrol-Copper OR Sodium-Copper-Chlorophyllin Versus Standard Treatment In Severe Covid-19 | A Phase-II, Open Label, Randomized Controlled Trial Of Resveretrol-Copper Plus Standard Treatment Or Sodium-Copper-Chlorophyllin Plus Standard Treatment Versus Standard Treatment In Hospitalized Patients With Pneumonia Due To SARS-CoV-2 (Covid-19) | | Tata Memorial Centre | 24-05-2020 | 20200524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43940 | Not Recruiting | No | | | | 01-06-2020 | 200 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2 | India→ | Vikram Gota→ | | Department of Clinical Pharmacology, Actrec,Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai → | vikramgota@gmail.com→ | 7715019117→ | ACTREC,→ | Inclusion criteria: 1 Male and non-pregnant female patients <br/ ><br>2 Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen <br/ ><br>3 Pneumonia confirmed by chest imaging <br/ ><br>4 Oxygen saturation (Sao2) of 94% or less while they were breathing ambient air <br/ ><br>5 Either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 3 (CTCAE Version 5.0) abnormalities in any of these parameters. <br/ ><br>6 Patients with high blood sugar or glycosylated haemoglobin, of any degree will be eligible <br/ ><br>7 Arterial blood gas, if done, could have abnormal values of pH, PO2, PCO2 and bicarbonate levels→ | Exclusion criteria: Asymptomatic or only mildly symptomatic→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Resveratrol-Copper tablets: Patients will receive Resveratrol-Copper tablets. Each tablet contains 5.6 mg of Resveratrol and 560 ng of Copper. Route - per oral.<br>Frequency - 1 tablet 4 times per day. Duration - From the date of randomization to the day of discharge or death, whichever is earlier. Patients in this arm can also receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs.<br>Intervention2: Chlorophyllin tablets: Patients will receive oral Chlorophyllin tablets daily under fasting conditions at a dose of 750 mg OD from the date of randomization to the day of discharge or death, whichever is earlier. Patients in this arm can also receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs.<br>Control Intervention1: Standard treatment: Patients in this arm can receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs. However, patients in this arm cannot receive Resveratrol -Copper treatment. The treatment proptocol will be in sync with the emerging scientific evidence and evolving national guidelines<br>→ | The time to clinical improvement, defined as a 2-point improvement on a 7-point ordinal scale will be the primary endpoint.Timepoint: Day 28→ | | | | Yes | False | | |
| → | CTRI/2020/05/025335 | 27 January 2021 | Efficacy of AYUSH-64 (a polyherbal formulation) in COVID - 19 Cases
| A Pilot Study To Assess The Efficacy Of AYUSH - 64 In COVID - 19 Cases
| | Central Council for Research in Ayurvedic Sciences CCRAS | 24-05-2020 | 20200524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43949 | Not Recruiting | No | | | | 20-06-2020 | 40 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr N R Singh→ | | CBPACS, Khera Dabar, Najafgarh New Delhi 110073 Additional Director office, room no G-31, CBPACS, Khera Dabar, New Delhi 110073→ | addl.director.academics@gmail.com→ | 9560659728→ | Chaudhary Bahm Prakash Ayurved Charak Sansthan, New Delhi→ | Inclusion criteria: Mild to moderate cases registered in CHC CBPACS above 18 years of age, with COVID 2019 (Confirmed by RT-PCR) <br/ ><br>Participants who can take medicines orally <br/ ><br>Patients willing to provide signed informed consent <br/ ><br>→ | Exclusion criteria: Cases of severe vomiting which would make oral administration of medicine difficult. <br/ ><br>Cases of respiratory failure and requiring mechanical ventilation. <br/ ><br>Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 2 times the upper limit of normal. <br/ ><br>Patients with COVID 19 in critical condition or ARDS or NIAD 8 â??point ordinal score 2 Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation <br/ ><br>Pregnant or lactating women <br/ ><br>Any other condition, which as per the investigator would jeopardize the outcome of the trial. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayush-64, a polyherbal formulation.<br>: The composition of AYUSH 64 includes aqueous extract of Saptaparna (Alstoniascholaris R. Br.) Katuki (Picrorhizakurroa Royle ex. Benth), Kiratatikta (SwertiaChirataPexbex. Karst) and powder of Kuberaksha (Caesalpinia crista Linn.) in the ratio of 1:1:1:2.Dose:- 2 Tablets (500 mg) thrice daily (2-2-2)<br>Dosage form:- Tablet<br>Route of Administration:- Oral<br><br>Time of Administration:-after food<br><br>Anupana:- Warm water<br> <br>Duration of therapy:- 14 days <br><br>Control Intervention1: Not applicable: Not applicable<br>→ | a) Mean time (days) for clinical recovery as per clinical recovery criteria defined below <br/ ><br>b) Number of patients showing â??clinical recoveryâ?? <br/ ><br>Timepoint: Baseline <br/ ><br>Day 8 <br/ ><br>Day 15→ | | 11/08/2020 | | Yes | False | | |
| → | CTRI/2020/05/025339 | 27 January 2021 | Treatment and economical problems faced due to non COVID patients admitted in severe acute respiratory illness (SARI) ICU based on SARI criteria | SARI definition- treatment and economic implications on non COVID patients admitted to SARI ICU | | Kasturba Medical college | 24-05-2020 | 20200524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43959 | Not Recruiting | No | | | | 02-06-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sunil R→ | | Department of critical care medicine
Kasturba medical college and hospital
Madhav Nagar
Manipal → | sunil.r@manipal.edu→ | 8095800142→ | Kasturba Medical college→ | Inclusion criteria: patients fulfilling SARI criteria→ | Exclusion criteria: confirmed COVID case→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J22- Unspecified acute lower respiratory infection
→ | Intervention1: NIL: NIL<br>→ | To determine the treatment and economic implications on admitted non COVID patients in SARI ICU based on SARI criteria.Timepoint: Delay in the treatment/ procedures <br/ ><br>Morbidity <br/ ><br>Mortality <br/ ><br>Risk of acquiring nosocomial covid -19 infection <br/ ><br>Increased days of hospital stay <br/ ><br>ASSESSED AT 28 DAYS (4 WEEKS) AFTER SARI ICU ADMISSION→ | | | | Yes | False | | |
| → | CTRI/2020/05/025340 | 27 January 2021 | Clinical trial of ShatPlus in SARS-CoV-2 Infection. | Clinical trial to evaluate the safety and efficacy of ShatPlus an Ayurvedic Proprietary Medicine as an intervention in adult patients with SARS-CoV-2 infection. | | BVG Life Sciences Ltd BVG Group | 24-05-2020 | 20200524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44005 | Not Recruiting | No | | | | 01-06-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 1/ Phase 2 | India→ | Dr Pawan Kumar Singh→ | | Sagar Complex, Opposite Kasarwadi Railway Station,
Near Nashikphata, Old Pune-Mumbai Road,Chinchwad, Pune - 411034, India → | pawan.singh@bvglife.com→ | 9409616256→ | BVG Life Sciences Ltd. (BVG Group)→ | Inclusion criteria: SARS-CoV-2 positive nasopharyngeal swab <br/ ><br>Mild to Moderately severe disease (NEWS score â?¤ 8) <br/ ><br>Signed informed consent must be obtained and documented according to AYUSH GCP, and national/local regulations→ | Exclusion criteria: Requiring ICU admission at screening <br/ ><br>History of MI, Epileptic episodes <br/ ><br>Any other comorbidity which is at critical stage at screening <br/ ><br>Any other condition by which subject proves unfit from investigator perspective→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ShatPlus along with standard treatment: 10 ml thrice a day ShatPlus along with standard treatment<br>Control Intervention1: Standard treatment: Standard treatment as per protocol of ICMR<br>→ | No. of days for negative PCR confirmatory test from nasopharyngeal swab for SARS-Covid 2 <br/ ><br>Serum levels of CD4, CD8, NK cell panel CD16/CD56, CRP, IgM, IgGTimepoint: From baseline to end of study ie 10 days→ | | | | Yes | False | | |
| → | CTRI/2020/05/025341 | 27 January 2021 | A study to know the effect of Ayurvedic Kwath(Kiratiktadi Kwath) & Ashwagandha Churna along with yoga exercises in the treatment of COVID-19 Positive patients. | Efficacy of Kiratiktadi Kwath & Ashwagandha Churna with Yoga modalities
in management of COVID -19 patients.
| | NO | 24-05-2020 | 20200524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44013 | Recruiting | No | | | | 02-06-2020 | 30 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India→ | Ankur Singhal→ | | Department of Kayachikitsa,
GS Ayurveda Medical College & Hospital, NH-9, NEAR RAILWAY STATION,
POST-PILKHUWA
DISTRICT- HAPUR → | drankursinghal2015@gmail.com→ | 09760768689→ | GS Ayurveda Medical College & Hospital, Pilkhuwa→ | Inclusion criteria: 1) COVID 19 positive cases with mild symptoms or Asymptomatic <br/ ><br>2) Age: above 20 yrs or below 60 yrs of either sex. <br/ ><br>→ | Exclusion criteria: 1) Cases suffering from any co morbidities. <br/ ><br>2) Age below 20 or above 60 yrs <br/ ><br>COVID -19 negative cases. <br/ ><br>3) If the patient develops any systemic side effects. <br/ ><br>Symptoms of COVID-19 aggravated to moderate level during study. <br/ ><br>4) Moderate and Severe patients of COVID-19→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
Health Condition 3: B338- Other specified viral diseases
→ | Intervention1: 1) Kiratiktadi Kwath 30 ml twice a day before food for 14 days.<br>2)Ashwagandha churna 5gm before sleep with luke warm water. for 14 days<br>3) Yoga exercises 45 min twice a day empty stomach for 14 days.<br>4)Immunobooster Ayush Kwath as ministry of ayush guidlines 40 ml once a day (early morning , empty stomach): 1) Kiratiktadi Kwath as mentioned in sharngdhar samhita in kwath prakaran.<br>2) Aswagandha churna as mentioned in rasayan adhikar in chakradatt tika.<br>3) Yoga exercises including pranayam, suryanamaskar etc. as per MDNIY, NEW DELHI<br>Control Intervention1: MODERN TREATMENT as per UP Govt Norms to asymptomatic and mild cases.: MODERN TREATMENT as per UP Govt Norms to asymptomatic and mild cases.<br>→ | Efficacy of Kiratiktadi Kwath & Ashwagandha Churna with yoga modalities in the management of mild and asymptomatic cases of COVID-19 PatientsTimepoint: approx 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/025343 | 27 January 2021 | Study results of Ayurvedic treatment on COVID patients using proprietary herbal formulation SUVED and whole colostrum REIMMUGEN. | Integration of Ayurvedic proprietary formulation (SUVED) and Whole Colostrum (REIMMUGEN) intervention given together, to reduce morbidity and mortality in suspected and confirmed COVID patients admitted to COVID ward in Pune. - SU-REM-COVID | | Health Solutions | 25-05-2020 | 20200525 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43919 | Not Recruiting | No | | | | 30-05-2020 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Sujata Vaidya→ | | B 902
Teerth Towers
Baner Annex
Pune → | drsujatavaidya@gmail.com→ | 9822311565→ | Health Solutions→ | Inclusion criteria: Patients admitted to COVID ward; symptomatic or non-symptomatic. <br/ ><br>Patients under observation in COVID quarantine.→ | Exclusion criteria: Below age 18, pregnant and lactating women; Patients in COVID ICU with ventilator support.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | Intervention1: proprietary Ayurvedic SUVED: Whole Colostrum REIMMUGEN: Oral, additional, Ayurvedic intervention given for 15 days in addition to ongoing treatment.<br>DOSAGE<br>SUVED capsules. 1 BD, <br>Reimmugen 1 TDS<br>both together with water before meals:<br>Intervention2: REIMMUGEN whole colostrum: oral capsules taken additional to regular treatment of Whole colostrum; dosage 1 TDS with plenty water before meals<br>Control Intervention1: not applicable: COVID treatment protocol<br>→ | MortalityTimepoint: 15 days or at discharge for any reason→ | | | | Yes | False | | |
| → | CTRI/2020/05/025345 | 27 January 2021 | Detailed Organ System Analysis of Asymptomatic COVID19 patients using noninvasive mobile tool | Non Invasive Detection and Monitoring of Corona Virus from Lyfas Mobile tool | | Acculi Labs PvtLimited | 25-05-2020 | 20200525 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43948 | Recruiting | No | | | | 05-06-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Rishikesh Ranjan→ | | 31 ground floor, 3rd cross, Basappa layout, Near BHEL water tank, Pattangere, Raja Rajeshwari Nagar, Bangalore → | pooja.sharma@medanta.org→ | 0124-4141414→ | Medanta Institute of Education and Research→ | Inclusion criteria: 1. Subjects must be divided into two major groups: <br/ ><br>A) Controlled Group <br/ ><br>B) Uncontrolled Group <br/ ><br> <br/ ><br>Control Group: <br/ ><br>Proven cases of COVID-19 with or without other health issues like COPD, DM, HTN etc <br/ ><br> <br/ ><br>Uncontrolled Group: <br/ ><br>Asymptomatic patients who are not COVID-19 positive, which can be either those who tested negative or normal public. <br/ ><br>→ | Exclusion criteria: 1. Terminally ill patients with severe pneumonia <br/ ><br>2. Patients with sepsis <br/ ><br>3. Patients on ventilator <br/ ><br>4. Patients below age of 5 years <br/ ><br>5. Patients not willing to give written informed consent <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | The study should prove that Lyfas corona Virus Profile indicator can be used to detect corona virus risk at an asymptomatic stage and can be used to monitor the suspected person with significant statistical correlation in range of patients with different clinical and demogroaphic background.Timepoint: Day 1,3,6 and 10.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025347 | 27 January 2021 | Psychological impact of COVID-19 pandemic on health care workers | Weathering the storm: Psychological impact of COVID-19 pandemic on clinical and non-clinical health care workers | | Kasturba Medical College | 25-05-2020 | 20200525 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43958 | Not Recruiting | No | | | | 01-06-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Margiben Tusharbhai Bhatt→ | | Department of Critical care medicine, Kasturba medical college and hospitals, Madhavnagar, Manipal, Karnataka, India. → | sunil.r@manipal.edu→ | 8095800142→ | Kasturba Medical College, Manipal→ | Inclusion criteria: Clinical and non-clinical Health care workers aged > 21 years→ | Exclusion criteria: Healthcare workers with pre-existing psychiatric illness, Healthcare workers not consenting for the study <br/ ><br>→ | | | To study the psychological impact in terms of insomnia, depression, anxiety, and stress experienced by the health care workers in India.Timepoint: outcomes will be assessed only at baseline, at a given point of time→ | | | | Yes | False | | |
| → | CTRI/2020/05/025348 | 27 January 2021 | Medical students preference and perspective for online teaching during lockdown period | Online teaching for medical students during lockdown phase of Covid 19: Student perceptions and preference | | apurv barche | 25-05-2020 | 20200525 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43979 | Not Recruiting | No | | | | 01-06-2020 | 800 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Apurv Barche→ | | Department of Pediatrics, Women and children block, Kasturba Hospital, Kasturba Medical college, Manipal, Udupi, KArnataka , India 576104 → | apurvbarche@yahoo.com→ | 7470345111→ | Kasturba Medical College, Manipal→ | Inclusion criteria: The MBBS students who have attended in online teaching using live and recorded lecture and gives consent for the study.→ | Exclusion criteria: The MBBS students who did not attend online teaching using live and recorded lecture or refused to consent for the study.→ | | | Student perceptions and preference for Online teaching for medical students - Mean attitude scores will be measured for the feedback items reported on five-point Likert scale. A thematic analysis will be undertaken for open ended questions asked in the survey.Timepoint: One time response→ | | | | Yes | False | | |
| → | CTRI/2020/05/025344 | 27 January 2021 | Effects of the corona virus disease on mental health of Anaesthesiologists working at different parts of India. | Effects of the COVID-19 Pandemic on mental health of Anaesthesiologists working at different parts of India. | | All India Institute of Medical Sciences Bhubaneswar | 25-05-2020 | 20200525 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44024 | Not Recruiting | No | | | | 08-06-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DR Neha Singh→ | | Department of Anaesthesiology and Critical Care, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Pin-751019 Odisha, India
→ | anaes_neha@aiimsbhubaneswar.edu.in→ | 9438884045→ | All India Institute of Medical Sciences, Bhubaneswar→ | Inclusion criteria: Anaesthesiologists of either sex aged 28 â?? 65 years taking care of patients during COVID-19 pandemic.→ | Exclusion criteria: Not willing to take the survey→ | | | To study the psychological impact of COVID-19 pandemic on Anaesthesiologists working at different parts of India during the COVID -19 pandemic.Timepoint: After completion of the survey.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025346 | 27 January 2021 | A Clinical Trial to Assess the Safety and Efficacy of Convalescent Plasma in Severe Covid-19 patients. | A Phase II, Open Label, Randomized Controlled Trial to Assess the Safety and Efficacy of Convalescent Plasma in Severe Covid-19 patients. | | Government of TamilNadu | 25-05-2020 | 20200525 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43005 | Not Recruiting | No | | | | 01-06-2020 | 90 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrJAYANTHI RANGARAJAN→ | | Madras Medical College and Rajiv Gandhi Government General Hospital, Chennai 6A Sagath Srinivas
2nd Street Srinivasapuram
Thiruvanmiyur 600041
Chennai→ | dranbuselvimk@gmail.com→ | 9940840760→ | Madras Medical College,→ | Inclusion criteria: A. INCLUSION CRITERIA FOR DONOR: <br/ ><br> Convalescent plasma: Eligibility of Donor <br/ ><br>Potential donors will include the following: <br/ ><br>1. Prior diagnosis of COVID-19 documented by a laboratory test , treated and completely recovered from Covid infection. <br/ ><br>2. Complete resolution of symptoms and at least one negative lab test for Covid-19 at least 28 days prior to donation (as per NBTC guidelines after Covid -19 pandemic for donor selection). <br/ ><br>3. If plasma is collected prior to 28 days after full recovery from illness, then confirmation of the resolution of the infection should be obtained through demonstration of two nasopharyngeal swab tests for SARS-CoV-2 performed at an interval of at least 24 hours on nasopharyngeal swabs. <br/ ><br> These individuals will be contacted telephonically and explained the details of the study and their extent of participation. If requested, they will be provided transport for the same. <br/ ><br>Donor eligibility criteria: <br/ ><br>The following eligibility criteria will be applied towards potential donors: <br/ ><br>1. Only males and nulliparous female donors of weight > 55 kgs will be included. <br/ ><br>2. Donor eligibility criteria for whole blood donation as per the departmental SOP will be followed in accordance to the Drugs & Cosmetics Act 1940 and rules 1945 therein (as amended till March 2020). Donor will be screened, followed by brief physical examination. <br/ ><br>3. Donors not fit to donate blood based on the history and examination will be deferred and excluded from plasma donor pool for a time period specified by country regulation & departmental SOPs. <br/ ><br>4. In addition to the afore mentioned donor eligibility criteria, two EDTA samples (5 ml each) and one plain sample (5 ml) will be drawn for the following pre-donation tests as required for convalescent plasmapheresis (CPP). <br/ ><br>a) Blood group and antibody screening â?? Antibody screen positive donors will be deferred. <br/ ><br>b) Donors with Hb >12.5g/dl, platelet count >1,50,000 per microliter of blood and TLC within normal limits will be accepted. <br/ ><br>c) Screening for HIV, HBV and HCV by serology or NAT. Donor negative by both the tests will be included. <br/ ><br>d) Screening for syphilis and malaria by serology. Negative donors will be included <br/ ><br>e) Total serum protein. Donors with total serum protein > 6gm/dl will be accepted (as per Drugs and Cosmetics (Second Amendment) Rules, 2020) <br/ ><br>f) Presence of IgG and IgM antibodies to covid-19 by quantification test as per manufacturerâ??s instruction. Donors negative for these will be deferred. <br/ ><br>g) Titration of anti-covid-19 (both IgG and IgM) antibodies and SARS-CoV-2 neutralizing antibodies may be done depending on availability of facilities at the time of testing. (Desired titers for IgG antibodies >1024 or neutralizing antibodies >40) doubling dilution of donor serum will be done and titration will be done using CLIA. If not done at the time of plasma collection the donor samples will be stored in aliquots at -80° C to be tested at a later date. <br/ ><br>h) Molecular test for covid-19 either from nasopharyngeal swab specimens may be done depending on availability of tests. Donorâ??s positive will be deferred. <br/ ><br> <br/ ><br>B. INCLUSION CRITERIA FOR RECIPIENT OF CCP: <br/ ><br>1. Age should be above 20 years for both genders. <br/ ><br>2. Covid positive patients who are under treatment in the covid acute care facility, amongst whom are willing to give consent to p→ | Exclusion criteria: EXCLUSION CRITERIA FOR DONOR: <br/ ><br>Covid-19 infected patients who are under treatment with the criteria: <br/ ><br>1. Consecutive 2 swabs positive for covid-19 <br/ ><br>2. One molecular test for covid-19 positive â?? RT-PCR. <br/ ><br>3. Clinically symptoms suggestive of covid-19. <br/ ><br>4. Multiparous female and patient with co morbid conditions. <br/ ><br> <br/ ><br>EXCLUSION CRITERIA FOR RECIPIENTS: <br/ ><br>1. Patients with any past history of transfusion reactions to blood products. <br/ ><br>2. Receipt of Pooled Immunoglobulin in last 30 days <br/ ><br>3. Critically ill patients: respiratory failure, Sepsis, Multiorgan failure, Shock (Requiring Vasopressor to maintain a MAP â?¥ 65mmHg or MAP below 65 mmHg) <br/ ><br>4. Participating in any other clinical trial <br/ ><br>5. Pregnant and lactating women. <br/ ><br>6. Patients infected with Covid-19 not under criteria for severe covid condition. <br/ ><br>7. Patients with any chronic history of coronary artery disease, coronary bypass surgery, acute pulmonary edema, Pulmonary embolism, Congestive heart failure, Malignant hypertension, Polycythemia Vera, Severe renal failure, Cirrhosis and with any implants.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Treatment Arm: In treatment arm are 30 participants who are severe Covid patients being treated in acute care facility, apart from receiving standardized acute care treatment, they will also be transfused, initially with one unit of 200ml of ABO compatible convalescent plasma and subsequent dose of 200ml after 24 hours of the initial dose.<br>Control Intervention1: Control Arm: In control arm are 30 participants who are severe Covid patients being treated in acute care facility and who will be receiving only the standardized acute care treatment for the disease<br>→ | To prevent progression to severe ARDS (P/F ratio 100) and all-cause Mortality at 1 month. <br/ ><br>Timepoint: Improvement of clinical symptoms and investigations will be monitored daily for first 3 days, and on day 7, 14, 21, 28, once a month till 3 months.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025350 | 27 January 2021 | Study to assess safety and efficacy of Inj Sepsivac in patients of Covid-19 | Observational study to assess safety and efficacy of Inj Sepsivac in patients of Covid-19 at R D Gardi Medical College, Ujjain, India | | R D Gardi Medical College | 26-05-2020 | 20200526 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43559 | Not Recruiting | No | | | | 31-05-2020 | 50 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Dr Ashish Pathak→ | | 3rd Floor, Department of Pediatrics
C R Gardi Medical College R D Gardi Medical College
Agar Road, Surasa→ | drashish.jpathak@gmail.com→ | 9302239899→ | R D Gardi Medical College→ | Inclusion criteria: Patients between the age of 18 â?? 65 years diagnosed to have Covid19 infection confirmed by RTPCR assay, <br/ ><br>and <br/ ><br>any one or more of the following <br/ ><br> <br/ ><br>1. Either an oxygen saturation of 94% or less while the patient was breathing ambient air or a need for oxygen support <br/ ><br>2. Creatinine clearance above 30 ml per minute <br/ ><br>3. Serum levels of ALT and AST less than five times the upper limit of the normal range <br/ ><br>4. Requirement of vasopressor <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Pregnant or nursing female. <br/ ><br>2. Patient previously enrolled into similar study. <br/ ><br>3. Patient participating or having participated in a clinical trial with another investigational drug within the last 28 days except for investigational drugs against cancer, leukaemia or HIV. <br/ ><br>4. Patients not likely to complete the trial as per judgment of the investigator.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Inj. Sepsivac: 0.3 ml/day of Inj. Sepsivac will be administered as intra-dermal injections for three consecutive days as 0.1ml x 3 injections at different sites along with standard therapy ofCovid-19.<br><br>The investigational product is an auto claved suspension in physiological saline of Mw .Each dose of 0.1ml contains: <br>Mycobacteriumw,(heatkilled) 0.5x109 <br>Sodium ChlorideI.P. 0.9%w/v<br>Thimerosal I.P. 0.01%w/v(As a Preservative)<br>Water for injection I.P. q.s.to 0.1ml<br><br>→ | Clinical improvement, as defined by live discharge from the hospital, a decrease of at least 2 points from baseline on a modified ordinal scale (as recommended by the WHO R&D Blueprint Group) <br/ ><br> <br/ ><br>Conversion of Covid19 status to negativeTimepoint: 28 days→ | | | | Yes | False | | |
| → | CTRI/2020/05/025370 | 27 January 2021 | Evaluation of Role of Ayurvedic Drug- Guduchi Ghan Vati in the treatment of COVID-19 related illness | Evaluation of Efficacy and Safety of Ayurveda Intervention (Guduchi Ghan Vati) in the management of COVID-19 infection (Asymptomatic & Mild symptoms)- An open label single arm prospective clinical trial. | | Dr SR Rajasthan Ayurved University Jodhpur | 27-05-2020 | 20200527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44064 | Not Recruiting | No | | | | 04-06-2020 | 40 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | DR SANJAY SRIVASTAVA→ | | Department of Shalya Tantra, University College of Ayurveda, Room Number 162, Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur
→ | vc.dsrrau@gmail.com→ | 8800543828→ | Dr. S.R. Rajasthan Ayurved University, Jodhpur→ | Inclusion criteria: 1. All hospitalized cases above 18-60 years of age, clinically diagnosed with corona virus disease 2019 (Covid19) and who are asymptomatic or having Mild symptoms. <br/ ><br>2. Participants who can take medicines orally. <br/ ><br>3. Patients willing to provide signed informed consent. <br/ ><br>→ | Exclusion criteria: 1. Cases of severe vomiting which would affect oral administration of medicine difficult. <br/ ><br>2. Cases of respiratory failure and requiring mechanical ventilation. <br/ ><br>3. Patients having Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper range of normal limits. <br/ ><br>4. Patients with COVID-19 in critical condition or ARDS or NIAD 8 â??point ordinal score-2 (Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation <br/ ><br>5. Combined organ failure requiring ICU monitoring. <br/ ><br>6. Patients with uncontrolled Diabetes Mellitus, (HbA1c more than 8.0), Malignant Hypertension (systolic BP more than 180 and diastolic 110), Chronic Renal Failure and those on immunosuppressive medication. <br/ ><br>7. Patients with history of malignancy, IHD, CAD, triple vessel disease, history of CABG, Stroke, etc. <br/ ><br>8. Any other condition, which as per the investigator would jeopardize the outcome of the trial. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Guduchi Ghan Vati: Dose: 500mg- BD(Twice a day),<br>Route of Administration- Oral,<br><br>Duration- 30 days<br>Control Intervention1: Not applicable: Not applicable<br>→ | 1. Clinical cure rate: Time to get a negative status of Covid-19. (defined as viral load of respiratory specimen negative for two consecutive times when tested in an interval of two days) [Time frame 1 month]Timepoint: [Time frame 1 month]→ | | | | Yes | False | | |
| → | CTRI/2020/05/025385 | 27 January 2021 | Research study to evaluate the impact of Selected Ayurvedic interventions in containment zone | A prospective non-randomized open label controlled interventional study on the effect of Guduchi Ghan Vati/ Sudarshan Ghan Vati as a prophylactic measure among Containment Zone population exposed to COVID 19" | | Central Council for Research in Ayurvedic Sciences | 27-05-2020 | 20200527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43953 | Not Recruiting | No | | | | 01-06-2020 | 30000 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Vipin Sharma→ | | Central Council for Research in Ayurvedic sciences, Janakpuri, New Delhi 110058 Room Number 103, Jawaharlal Nehru Anusandhan Bhawan, Janakpuri→ | sharma.vipin@nic.in→ | 9899437195→ | CCRAS→ | Inclusion criteria: 1. Participants who are from a community where at least 1 confirmed case is already identified. <br/ ><br>2. Participants who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br>→ | Exclusion criteria: â?¢ Known cases Covid-19. <br/ ><br>â?¢ Pregnant and Lactating females <br/ ><br>â?¢ Known cases of uncontrolled Diabetes and Hypertension <br/ ><br>â?¢ Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>â?¢ Participants having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>â?¢ Participants taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>â?¢ Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>â?¢ Participants having a history of allergy to any medicine that is part of the Ayurvedic intervention. <br/ ><br>â?¢ Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol <br/ ><br>→ | | Intervention1: guduchi Ghan Vati/Samshamani Vati: 1 gm per person/day, 500 mg two times (BID) for 30 days. Route would be oral<br><br>Control Intervention1: Hand sanitizer<br>Face Mask<br>Social Distancing: To be complied as per the central/state guidelines<br>→ | Comparative assessment of occurrence of COVID-19 infection in Clinically stable participants in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic CareTimepoint: 0, two weeks, 4 weeks, 6 weeks.→ | | 17/08/2020 | | Yes | False | | |
| → | CTRI/2020/05/025369 | 27 January 2021 | A study on treatment of COVID-19 patients with study drug along with standard of care | A Multi-center, Randomized Controlled, Phase III Study to evaluate the Clinical Outcomes and Safety of Tocilizumab along with
Standard of Care in Patients with Cytokine Release Syndrome associated with COVID-19 infection
- COVINTOC | | Medanta Institute of Education and Research MIER | 27-05-2020 | 20200527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43485 | Recruiting | No | | | | 30-05-2020 | 180 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 3 | India→ | Kuldeep K Chauhan→ | | Medanta-The Medicity Sector-38, Gurgaon, Haryana-122001, India → | pooja.sharma@medanta.org→ | 01244855100→ | Medanta Institute of Education and Research (MIER)→ | Inclusion criteria: I. Male or female subjects who are â?¥18 years of age, on the day of signing informed consent. <br/ ><br>II. Patient or Legally Acceptable Representative (LAR) willing to give informed Consent before study procedure. <br/ ><br>III. Hospitalized with COVID-19 infection confirmed per WHO criteria (including a positive PCR of any specimen; e.g., respiratory, blood, urine, stool, other bodily fluid). <br/ ><br>IV. Moderate to severe COVID 19 infection (moderate disease â?? increased respiratory rate 15 to 30/minute and SpO2 90%-94%; and severe disease - respiratory rate â?¥ 30/minute and/or SpO2 < 90% on room air, or ARDS or Septic shock <br/ ><br>→ | Exclusion criteria: I. Known severe allergic reactions to TCZ or other monoclonal antibodies <br/ ><br>II. Active tuberculosis (TB) infection. <br/ ><br>III. Suspected or active bacterial, fungal, viral (except treated HCV or HBV infection), or other infection (besides COVID-19). <br/ ><br>IV. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ ><br>V. Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with in the past 6 months. <br/ ><br>VI. Participating in other drug clinical trials <br/ ><br>VII. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination <br/ ><br>VIII. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization <br/ ><br>IX. Any serious medical condition or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the patient safe participation in and completion of the study. <br/ ><br>X. Definite diagnosis of rheumatic immune related diseases. <br/ ><br>XI. Administration of steroids equivalent to methylprednisolone at a dose >1mg/kg/day) at screening/baseline <br/ ><br>XII. Absolute Neutrophil count <500, platelet count <50,000 per microliter at screening/baseline <br/ ><br>XIII. Alanine aminotransferase (ALT) or aspartate aminotransferase(AST) >10 times upper limit of normal detected with-in 24 hours at screening/baseline <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tocilizumab and Current Standard of Care: Dose: 6 mg/kg (up to a maximum of 480 mg), Frequency: Once, Route of Administration: Intravenous Infusion, Total duration of administration: 1 Hour and Standard of CARE will be as per individual Hospital (Study Site) Policy<br>Control Intervention1: Current Standard of Care: Standard of CARE will be as per individual Hospital (Study Site) Policy<br>→ | Proportion of subjects showing progressive COVID 19 disease from moderate to severe, or from severe disease to deathTimepoint: Up to Day 14→ | | | | Yes | False | | |
| → | CTRI/2020/05/025371 | 27 January 2021 | Retrospective Assessment of Treatments of Hospitalized COVID19 Patients. | Retrospective Assessment of Treatments of Hospitalized Covid-19 Patients | | Entrepreneurship Development Center Venture Center | 27-05-2020 | 20200527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44023 | Not Recruiting | No | | | | 02-06-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ravindra Ghooi→ | | E 516 The Island Shankar Kalate Nagar Wakad Pune → | sundeepsalvi@gmail.com→ | 9921211000→ | Pulmocare Research and Education (PURE) Foundation→ | Inclusion criteria: Data of the following types of subjects will be considered for inclusion: <br/ ><br>1. Patients diagnosed to be infected by Covid -19 by RT PCR. <br/ ><br>2. Patients who have either been discharged or have died of Covid-19 <br/ ><br>infection.→ | Exclusion criteria: NIL→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | Time to recovery/ discharge or death in hospitalized COVID-19 patients.Timepoint: At recovery/ discharge or death.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025425 | 27 January 2021 | Ayurvedic intervention (Chyawanprash) in the prevention of COVID-19 pandemic among Health Care Personnel | Evaluation of the efficacy of an Ayurvedic intervention (Chyawanprash) in the prevention of COVID-19 pandemic among Health Care Personnel â?? An open label single arm prospective study | | Central Council For Research in Ayurvedic Sciences | 28-05-2020 | 20200528 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44043 | Not Recruiting | No | | | | 02-06-2020 | 50 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | Dr Shivshankar Rajput→ | | IPD Building First Floor Central Ayurved Research Institute for cardiovascular Diseases, Road No. 66 Punjabi bagh west , New Delhi
West
DELHI
110026
India
IPD Building First Floor Central Ayurved Research Institute for cardiovascular Diseases, Road No.→ | drbabitayadav@gmail.com→ | 9910171143→ | CCRAS, J.L.N.B.C.A.H. Anusandhan Bhawan,no. 61-65, Institutional area, opposite D Block, Janakpuri→ | Inclusion criteria: 1. All healthcare professionals of 20 to 60 years willing to participate, who were negative for SARS- Cov-2 at screening, (tested by RT-PCR), at A & U, Tibbia hospital dealing with COVID-19, with or without co-morbid condition with exposure/chance of exposure to COVID 19 positive cases. <br/ ><br>2. Those who are willing to provide signed informed consent. <br/ ><br>3. High Risk Group- It includes doctors, nursing staff and other paramedical staff like attendant who are directly looking after and examining COVID patients. <br/ ><br>4. Low risk- other faculty members who are present in the institute but not visiting corona ward. <br/ ><br>→ | Exclusion criteria: 1. Pregnant and lactating females. <br/ ><br>2. Known case of Carcinoma lungs, CRF and CHF. <br/ ><br>3. Participants with any immunosuppressive medication or in an immune compromised state or hematological disease. <br/ ><br>4. Laboratory confirmed COVID-19 with or without symptoms. <br/ ><br>5. DM uncontrolled with medications. <br/ ><br>6. Any other criteria, as per the investigator would jeopardize the study. <br/ ><br>→ | | Intervention1: Chayapanprash (an Ayurvedic herbal preparation): Dose: 12 g twice daily.<br>Dosage form : Avaleha.<br>Route of Administration : Oral.<br>Time of Administration : Twice in a day- On empty stomach in the morning at least 1 hour before breakfast and two hours after dinner at night.<br>Anupana : Warm water. <br>Duration of therapy : 30 days.<br><br>Control Intervention1: Not applicable: Not applicable<br>→ | 1. Percentage of participants with SARS- Cov-2 positivity as estimated by RT-PCR of nasopharyngeal swab.Timepoint: Assessment on baseline and at the end of study that is 30th day→ | | 18/08/2020 | | Yes | False | | |
| → | CTRI/2020/05/025424 | 27 January 2021 | Clinical features and outcome of COVID-19 and non-COVID respiratory infection | Comparison of clinical profile, outcome and peripheral blood cell population data in children with COVID-19 and non-COVID acute severe respiratory infection - Pedscovid | | Christian Medical College | 28-05-2020 | 20200528 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44074 | Not Recruiting | No | | | | 04-06-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Leni G Mathew→ | | Department of Pediatrics, Christian Medical College
Vellore → | lenigm@gmail.com→ | 9500921016→ | Christian Medical College→ | Inclusion criteria: All children from birth to 16 years of age presented with ALRI as per IMNCI criteria→ | Exclusion criteria: Children with ALRI but having asthma, empyema, aspiration pneumonia→ | Health Condition 1: J180- Bronchopneumonia, unspecified organism
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Mode of oxygen therapy. Other interventions needed. Outcome from illnes- recovery or deathTimepoint: Baseline, 3rd day, 5th day and at dischargefrom hospital.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025398 | 27 January 2021 | Study to find out the results of Ayurvedic Kwath & Ashwagandha churna with Yoga exercises to prevent our health workers against corona virus infection. | Efficacy of Kiratiktadi Kwath & Ashwagandha churna with Yoga modalities in
prevention of infection against COVID -19 in Front line Health care workers
| | NO | 28-05-2020 | 20200528 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43831 | Recruiting | No | | | | 28-05-2020 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Prof Dr Ankur Singhal→ | | GS AYURVEDA MEDICAL COLLEGE & HOSPITAL,
POST-PILKHUWA
DISTRICT-HAPUR → | drankursinghal2015@gmail.com→ | 09760768689→ | GS Ayurveda Medical College & Hospital, Pilkhuwa→ | Inclusion criteria: Inclusive criteria <br/ ><br>Asymptomatic healthy cases appointed as front line health care workers. <br/ ><br>Age above 20 yrs or below 60 yrs of either sex. <br/ ><br>→ | Exclusion criteria: Exclusive Criteria <br/ ><br>Cases suffering from any co morbidities. <br/ ><br>Age below 20 or above 60 yrs <br/ ><br>Cases those are symptomatic to COVID-19 before study. <br/ ><br>→ | | Intervention1: 1) Kiratiktadi Kwath(Astadashang Kwath) for 14 days<br><br>2) Ashwgandha churna for 14 days<br><br>3) Yoga Modalities for 45 minutres: 1) Kiratiktadi Kwath (Astadashang Kwath) 30 ml twice a day empty stomach.ref-Sharangdhar Samhita -kwath prakaran - for 14 days<br><br>2)Ashwgandha churna 5gm with Milk Before sleep. for 14 days<br><br>3) Yoga modalities for 45 min twice a day empty stomach<br>Control Intervention1: NIL: NIL<br>→ | 1) Efficacy of Kiratiktadi Kwath & Ashwagandha Churna with Yoga modalities in boosting Vyadhikshamatwa and prevention against communicable diseases. <br/ ><br>2) Will help in overcoming the anxiety level and stress of healthcare workers. <br/ ><br>Timepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/025397 | 27 January 2021 | A study to evaluate the effect and safety of a phytopharmaceutical drug in treatment of Coronavirus infection | An open label, multicenter, randomized, controlled clinical trial to evaluate the efficacy and safety of Tablets of purified aqueous extract of Cocculus hirsutus in treatment of moderate COVID -19 disease | | Sun Pharmaceutical Industries Limited | 28-05-2020 | 20200528 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43702 | Not Recruiting | No | | | | 05-06-2020 | 210 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2 | India→ | Guruprasad Palekar→ | | Sun Pharma Laboratories Limited
Sun House,
201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400063
→ | maulik.doshi@sunpharma.com→ | 02656612829→ | Sun Pharma laboratories Limited→ | Inclusion criteria: Subjects will be included in the study if they meet all of the following criteria: <br/ ><br>1. Patient who provides written informed consent <br/ ><br>2. Male or non-pregnant, non-lactating female patient aged â?¥ 18 and â?¤ 75 years (both inclusive) <br/ ><br>3. Patients with body temperature > 37.3â?? with cough/ shortness of breath <br/ ><br>4. Patient with moderate COVID-19 infection having either one of the following criteria <br/ ><br>a. PaO2/ FiO2: 200-300 <br/ ><br>OR <br/ ><br>b. Respiratory Rate > 24/min and SaO2/ SpO2 â?¤ 93% on room air <br/ ><br>5. Patient with RT-PCR confirmed diagnosis of COVID-19 <br/ ><br>6. Patient who is able to take the drug orally and comply with study procedures <br/ ><br>7. Women of childbearing potential must have a negative urine pregnancy test prior to study entry <br/ ><br>→ | Exclusion criteria: Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria: <br/ ><br>1. Patient with persistent vomiting <br/ ><br>2. Patient with known active hepatitis, tuberculosis and definite bacterial or fungal infections <br/ ><br>3. Patient with altered mental state <br/ ><br>4. Patient with multiple organ failure requiring ICU monitoring and the treatment <br/ ><br>5. Patient with respiratory failure and requiring ventilation <br/ ><br>6. Patient with history of retinopathy or macular degeneration <br/ ><br>7. Patient with history of glucose-6-phosphate dehydrogenase (G6PD) deficiency <br/ ><br>8. Patient with prolonged QTc-interval at baseline ECG ( >450 ms in males or > 470 ms in females) <br/ ><br>9. Patient taking concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration <br/ ><br>10. Patient with history of hypersensitivity towards any drug of standard of care <br/ ><br>11. Patient with history of evidence of chronic interstitial infiltration at imaging <br/ ><br>12. Patient with history of hospitalization within the past six months for respiratory failure <br/ ><br>13. Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g., heart failure, COPD, hypertension, liver disease, chronic respiratory failure, chronic kidney disease, diabetes, anaemia etc.) that, in the opinion of the Investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results. <br/ ><br>14. Patient with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus. <br/ ><br>15. Patient who has received specific antiviral drugs ritonavir/ lopinavir, or chloroquine, <br/ ><br>hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week prior to admission <br/ ><br>16. Patient who has participated in another investigational study within 3 months prior to enrolment in this study. <br/ ><br>17. Investigators, study personnel, sponsorâ??s representatives and their first degree relatives. <br/ ><br>Note: Persistent vomiting is more than three episodes of vomiting in 12 hours, preventing adequate oral <br/ ><br>hydration→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Purified aqueous extract of Cocculus hirsutus (AQCH) tablets: 400 mg thrice daily (every 8±1 hours), 10 days<br>Dosage and Administration: Thrice daily at least 30 min before meal, preferably at the same time every day. Patient will also be given standard of care as per institutional practice.<br>Control Intervention1: Standard of care as per institutional practice: Standard of care as per institutional practice<br>→ | Proportion of patients showing clinical improvement <br/ ><br>Clinical improvement defined as patient meeting discharge criteria OR a 2 point improvement (from time of enrolment) in disease severity rating on the 7-point ordinal scale. <br/ ><br>Hospital Discharge Criteria is defined as resolution of symptoms, radiological improvement with a documented virological clearance in 2 samples at least 24 hours apart.Timepoint: Day 14→ | | 19/08/2020 | | Yes | False | | |
| → | CTRI/2020/05/025423 | 27 January 2021 | Pregnancy and COVID-19 Registry | National Registry of Pregnant Women with COVID-19 in India - PregCovid | | ICMR NATIONAL INSTITUTE FOR RESEARCH IN REPRODUCTIVE HEALTH | 28-05-2020 | 20200528 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43519 | Not Recruiting | No | | | | 01-06-2020 | 2000 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Rahul Gajbhiye→ | | Department of Clinical Research ICMR-National Institute for Research in Reproductive Health J M Street Parel Mumbai → | gajbhiyer@nirrh.res.in→ | 02224192036→ | ICMR-NIRRH→ | Inclusion criteria: Part A <br/ ><br>Medical Case records of pregnant women with COVID-19 admitted from 1st January to 31st May 2020 will be analyzed. The records of the Pregnant women died due to COVID-19 will also be analyzed <br/ ><br>Part B <br/ ><br>Medical records of all pregnant and/ post-partum women with COVID-19 in Maharashtra from 01.06.2020 will be evaluated for prospective data entry in the registry→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | 1. Incidence of COVID-19 in pregnancy <br/ ><br>2. Socio-demographic, epidemiological and clinical characteristics of pregnant women with COVID-19 <br/ ><br>3. Pregnancy outcomes in women with COVID-19 <br/ ><br>4. Neonatal outcomes in women with COVID-19 <br/ ><br>5. Response to treatment <br/ ><br>6. Modes of transmission of COVID-19 from mother to child <br/ ><br>Timepoint: at the end of 24 months→ | | | | Yes | False | | |
| → | CTRI/2020/05/025429 | 27 January 2021 | effect of Ashwagandha (Withania somnifera) as a prophylactic measure among high risk population (Health Care Workers/Containment Zone Population) exposed to COVID-19 | A prospective non-randomized open labeled controlled interventional study on the effect of Ashwagandha (Withania somnifera) as a prophylactic measure among high risk population (Health Care Workers/Containment Zone Population) exposed to COVID-19 - APC | | CCRASNIIMH | 29-05-2020 | 20200529 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44058 | Recruiting | No | | | | 10-06-2020 | 5000 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr PVV Prasad→ | | National Institute of Indian Medical Heritage (CCRAS),
Survey No.314, Revenue Board Colony,
Gaddiannaram, Hyderabad-500036, → | dr.saketram@gmail.com→ | 040-24067388→ | NIIMH-CCRAS, Ministry of AYUSH→ | Inclusion criteria: 1. Adult Male or Female subjects above the age of 18 years to 68 years <br/ ><br>2. Subjects who are froma community where at least 1 confirmed case is already identified. <br/ ><br>3. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br>→ | Exclusion criteria: 1. Pregnant and Lactating females <br/ ><br>2. Known cases of uncontrolled Diabetes and Hypertension. <br/ ><br>3. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>5. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>7. Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. <br/ ><br>8. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol <br/ ><br>→ | | Intervention1: ASHWAGANDHA: ASHWAGANDHA CAPSULE + Standard Prophylactic Care recommended by Government TelanganaHealth authorities<br>Control Intervention1: Standard Prophylactic Care: Standard Prophylactic Care recommended by Government of TelanganaHealth authorities<br>→ | 1. Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic CareTimepoint: 0 15 30 45 day→ | | | | Yes | False | | |
| → | CTRI/2020/05/025430 | 27 January 2021 | EFFECT OF AYURVEDA IMMUNO-MODULATOR DRUGS on HEALTH OF CORONA WARRIORS | A Cross Sectional Study To Observe The Health Status Of Personnels Engaged In Care Of Covid-19 Infected/Suspected Persons And Receiving Ayurveda Immuno-Modulator Drugs In Jodhpur City - CSOSC | | Dabur India Ltd | 29-05-2020 | 20200529 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44060 | Not Recruiting | No | | | | 03-06-2020 | 1000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 1 | India→ | Dr Prem Prakash Vyas→ | | Room no 155
University College of Ayurved
Dr S R Rajasthan Ayurved University
Nagour Road, Karwar, Jodhpur, Rajasthan Nagour Road, Karwar, Jodhpur, Rajasthan→ | drppvyas@gmail.com→ | 9414351871→ | Dr S R Rajasthan Ayurved University→ | Inclusion criteria: Person deployed in quarentine ward <br/ ><br>Person on hard duty <br/ ><br>family members of health care personnel <br/ ><br>willingness to participate in study <br/ ><br>Taking Ayurveda immunomodulator drugs ( Tab. Maha Sudarshan vati + Tab Samshamani Vati + Tab. Haridra→ | Exclusion criteria: Person below 18 yrs & above 65 yrs <br/ ><br>Preganant women <br/ ><br>Any medical condition for which the person is recieing any immunosupressive medicine <br/ ><br>Known case of malignancy→ | | | To boost immunity of engaged person in care of COVID-19 infected/ suscpected casesTimepoint: 15 days→ | | | | Yes | False | | |
| → | CTRI/2020/05/025431 | 27 January 2021 | A study to find our proportion of Covid 19 cases, need for hospital beds and utility of lockdown at Aurangabad | COVID-19 disease load, hospital preparedness and utility of lockdown: Observational study at Aurangabad | | Dr Jagannath Dixit | 29-05-2020 | 20200529 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44128 | Not Recruiting | No | | | | 08-06-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Jagannath Dixit→ | | Room No 2, Department of Community Medicine, Government Medical College, Panchakki Road, Aurangabad Room No 2, Department of Community Medicine, Government Medical College, Panchakki Road, Aurangabad→ | drjvdixit@gmail.com→ | 9922994777→ | Department of Community Medicine, Government Medical College→ | Inclusion criteria: All adults of age 18 years and above shall be included. They should be resident of Aurangabad for at least six months at the time of data collection.→ | Exclusion criteria: Migrant population <br/ ><br>Not giving consent→ | | | Percentage of households with Covid 19 infectionTimepoint: At 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/025428 | 27 January 2021 | COVID -19 Pandemic and Lockdown : Impact on Parents Stress level, Infant care and follow-up | COVID -19 Pandemic and Lockdown : Impact on Parents Stress level, Infant care and follow-up in a tertiary neonatal unit (CLIPSI study)â?? An Observational study - CLIPSI Study | | Nil | 29-05-2020 | 20200529 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43890 | Not Recruiting | No | | | | 29-05-2020 | 300 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Usha Devi R→ | | Department of Neonatology,
Sri Ramachandra Institute of Higher Education and Research, Porur → | dr.ushaa@gmail.com→ | 9962653294→ | Sri Ramachandra Institute of Higher Education and Research→ | Inclusion criteria: Parents of neonates born or admitted in our hospital during the COVID pandemic and lockdown will participate→ | Exclusion criteria: Parents who know neither Tamil or English language <br/ ><br>Parents who neither have internet connection or come for follow up visit <br/ ><br>→ | | Intervention1: Link for google doc self-administered questionnaire is sent through WhatsApp number of the parents if they are willing to participate in the study.: The parents of babies admitted from 25th of March will be approached over phone or during follow up in newborn clinic and for those who consent to participate in the study, the link for the structured questionnaire in the language they understand will be sent through WhatsApp (thus following social distancing norms). The structured questionnaire is developed by using google forms with a consent form appended to it. Parents responses to questions related to antenatal period, delivery, NICU stay, stress level, stay in the ward, discharge, follow-up and immunisation will be recorded.<br>→ | To identify the parental stress level using parent stress scale and perceived stress scale, <br/ ><br>To identify sources of stress for parents of neonates born or admitted in our tertiary level NICU during this COVID 19 pandemic and lockdown and <br/ ><br>To identify the difficulties encountered in neonatal care and follow up.Timepoint: Past 4-6 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/025427 | 27 January 2021 | Clinical Characteristics and Outcomes of Patients Admitted with Severe Acute Respiratory Illness | Clinical Characteristics and Outcomes of Patients Admitted with Severe Acute Respiratory Illness During the COVID-19 Pandemic: A Multicentric Observational Study From Karnataka | | Majumdar Shaw Medical Center | 29-05-2020 | 20200529 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43933 | Not Recruiting | No | | | | 30-05-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Jose Chacko→ | | Senior Consultant, Critical Care
Majumdar Shaw Medical Center
Bangalore Majumdar Shaw Medical Center
Bangalore→ | chackojose@gmail.com→ | 9844143041→ | Majumdar Shaw Medical Center Bangalore→ | Inclusion criteria: Patients admitted with Severe Acute Respiratory Illness (SARI) to the intensive care units of the study centers during the COVID-19 pandemic in the State of Karnataka→ | Exclusion criteria: Patients who are not admitted to the intensive care units→ | Health Condition 1: B998- Other infectious disease
Health Condition 2: B338- Other specified viral diseases
→ | | 13. Clinical outcomes (discharged from ICU, still in ICU, died, still in hospital) <br/ ><br>14. Ventilation days, ICU days <br/ ><br>Timepoint: Final follow-up planned in September 2020→ | | | | Yes | False | | |
| → | CTRI/2020/05/025434 | 27 January 2021 | A clinical trial to evaluate the Medicinal effects of ZingiVir-H as Anti-Viral therapy in COVID-19 patients. | Randomized, double-blind, placebo-controlled
prospective multicenter trial to validate the
safety and efficacy of an antiviral drug
zingivir-h, in adults with asymptomatic, mild or
moderate nCOVID-19 infection.
| | Pankajakasthuri herbal research foundation | 29-05-2020 | 20200529 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43957 | Recruiting | No | | | | 31-05-2020 | 135 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Outcome Assessor Blinded | Phase 4 | India→ | Dr J Hareendran Nair→ | | Pankajakasthuri Herbal research Foundation Pankajakasthuri Ayurveda Medical college and PG centre→ | drshan@pkhil.com→ | 9188325339→ | Pankajakasthuri Herbal research Foundation→ | Inclusion criteria: 1 Patients of both sexes aged from 18 years to 60 years old. <br/ ><br>2 Willing and able to provide written informed consent prior to performing study procedures by the subject or legal guardian willing and able to provide written informed consent prior to performing study procedures <br/ ><br>3.Patients with Severe Acute Respiratory Syndrome Coronavirus SARS-CoV2 COVID infection confirmed by RT Polymerase chain reaction RT-PCR test <br/ ><br> a PCR positive in sample collected 96 hours prior to randomization OR <br/ ><br> b PCR positive in sample collected 96 hours prior to randomization documented inability to obtain a repeat sample e.g. due to lack of testing supplies limited testing capacity results taking 24 hours or any other documented reasons etc. AND progressive disease suggestive of ongoing SARS-CoV-2 infection. <br/ ><br>4.Currently hospitalized and requiring medical care for COVID-19 <br/ ><br>5.Peripheral capillary oxygen saturation SpO2 94 percentage on room air at screening <br/ ><br>6.Radiographic evidence of pulmonary infiltrates OPTIONAL Criteria <br/ ><br> <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1.Any of the following would exclude the subject from participation in the study: <br/ ><br>2.Subject or Authorized Representative is unable to provide informed consent <br/ ><br>3.Subject is pregnant or breastfeeding ladies <br/ ><br>4.Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital <br/ ><br>5.Acute illness (defined as the presence of moderate or severe signs and symptoms related with the COVID infection) at the time of randomization <br/ ><br>6.Any current or expected receipt of immunosuppressive agents including steroids (except for the use of topical steroids according to the judgment of the investigator) <br/ ><br>7.History of receipt of blood transfusion or immunoglobulin products or expected receipt through the duration of the study <br/ ><br>8.Known hepatic dysfunction including known or suspected active or chronic hepatitis infection <br/ ><br>9.History of CLD/ bronchopulmonary dysplasia <br/ ><br>10.Clinically significant congenital anomaly of the respiratory tract <br/ ><br>11.Inability to take oral medication <br/ ><br>12.Prolonged QTc-interval in baseline ECG ( >500 ms) <br/ ><br>13.Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis <br/ ><br>14.Need of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics during the treatment period. <br/ ><br>15.Participation in another research study involving an investigational agent within 30 days prior to consent <br/ ><br>16.Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Zingivir-H: - ONE tablet (500 mg) each consumed once in 3 hours ±1 hour between 6 AM and 9 PM in a given day (6AM, 9AM, 12Noon, 3PM, 6PM, 9PM) totally six tablets per day for a minimum duration of 10 days to Maximum 15 days.<br>Control Intervention1: not applicable: Not applicable<br>→ | The odds of ratio for improvement on a 7 point ordinal scale on Day 15 and clearance of medically attended lung infection due to RT-PCR confirmed COVID19 infection , in Zingivir H treated group to the placebo group. <br/ ><br>Timepoint: base line , 7 th day, 15 th day <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/05/025466 | 27 January 2021 | A study to estimate drug levels in health care workers on COVID infection prophylaxis | Measurement of Hydroxychloroquine in blood in asymptomatic healthcare workers on prophylactic
regimen for COVID-19 infection - An observational study. | | Norwich Clinical Services PvtLtd | 29-05-2020 | 20200529 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43209 | Not Recruiting | No | | | | 03-07-2020 | 24 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Rajeev M Patil→ | | 147/F, 8th Main, 3rd Block, Koramangala, → | rajeev.patil@norwichclinical.com→ | 91-94825-72525→ | Norwich Clinical Services Pvt. Ltd.→ | Inclusion criteria: a. Able to give voluntary informed consent for collection of blood samples and <br/ ><br>relevant data for analysis and publication. <br/ ><br>b. Either gender, aged above 18 years.→ | Exclusion criteria: a. Volunteers who are already on hydroxychloroquine prophylaxis and have less <br/ ><br>than 5 weeks remaining out of 8 weeks of hydroxychloroquine prophylaxis for <br/ ><br>COVID-19 infection. <br/ ><br>b. Volunteers who are already on hydroxychloroquine prophylaxis and develop any adverse drug reaction (ADR) to hydroxychloroquine leading to hospitalization or discontinuation at any time.→ | | Intervention1: Nil.: Nil.<br>Control Intervention1: Nil.: Nil.<br>→ | To determine the peak and trough values achieved in blood over the course of the prophylactic drug administration.Timepoint: The estimated concentration for the sampling time points (hr) 0.00, 4.00, 168.00, 336.00, <br/ ><br>340.00, 504.00, 672.00, 676.00, 840.00, 1008.00 and 1176.00 will be reported with <br/ ><br>descriptive statistical analysis.→ | | 19/10/2020 | | Yes | False | | |
| → | CTRI/2020/05/025433 | 27 January 2021 | Respiratory emergencies during the COVID-19 Pandemic. | A Clinico-epidemiological study of respiratory emergencies treated at the emergency department during the COVID-19 pandemic in a tertiary care center in Karnataka. | | DrFreston Marc Sirur | 29-05-2020 | 20200529 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43743 | Not Recruiting | No | | | | 01-06-2020 | 700 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Freston Marc Sirur→ | | Department of Emergency Medicine, Kasturba Medical College, Manipal → | vivgopi@yahoo.com→ | 9447704419→ | Kasturba Medical College→ | Inclusion criteria: All patients requiring ventilatory support or at high risk of needing it.→ | Exclusion criteria: All patients not requiring ventilatory support and identified not to be a respiratory emergency as per the study.→ | Health Condition 1: J680- Bronchitis and pneumonitis due tochemicals, gases, fumes and vapors
Health Condition 2: I633- Cerebral infarction due to thrombosis of cerebral arteries
Health Condition 3: J441- Chronic obstructive pulmonary disease with (acute) exacerbation
Health Condition 4: J440- Chronic obstructive pulmonary disease with acute lower respiratory infection
Health Condition 5: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 6: S070- Crushing injury of face
Health Condition 7: G35-G37- Demyelinating diseases of the central nervous system
Health Condition 8: S062- Diffuse traumatic brain injury
Health Condition 9: D50-D89- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Health Condition 10: L00-L99- Diseases of the skin and subcutaneous tissue
Health Condition 11: I850- Esophageal varices
Health Condition 12: K74- Fibrosis and cirrhosis of liver
Health Condition 13: S028- Fractures of other specified skulland facial bones
Health Condition 14: I161- Hypertensive emergency
Health Condition 15: I130- Hypertensive heart and chronic kidney disease with heart failure and stage 1 through stage 4 chronic kidney disease, or unspecified chronic kidney disease
Health Condition 16: J09-J18- Influenza and pneumonia
Health Condition 17: S00-T88- Injury, poisoning and certain other consequences of external causes
Health Condition 18: I408- Other acute myocarditis
Health Condition 19: B998- Other infectious disease
Health Condition 20: J688- Other respiratory conditions due to chemicals, gases, fumes and vapors
Health Condition 21: J681- Pulmonary edema due to chemicals,gases, fumes and vapors
Health Condition 22: I260- Pulmonary embolism with acute corpulmonale
Health Condition 23: A15- Respiratory tuberculosis
Health Condition 24: J455- Severe persistent asthma
Health Condition 25: S061- Traumatic cerebral edema
Health Condition 26: S066- Traumatic subarachnoid hemorrhage
Health Conditi→ | | Disease burden of respiratory emergencies reporting to the emergency department. <br/ ><br>outcome and mortality of Respiratory emergencies.Timepoint: Data collection will go on for a period of 6 months from the date of CTRI approval. <br/ ><br>Data collection will stop on or before 11.01.2021 if 6 months of data collection is complete. If it is not then a request for an IEC extension amendment will be requested. <br/ ><br>All the outcome variables will be assessed after 6 months of data collection-anticipated January 2021. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/05/025483 | 27 January 2021 | Use of Clevira in COVID19 patients | A Randomized, Multicentric, Open label, Parallel group Clinical study to Evaluate the EFFICACY and SAFETY of CLEVIRA in mild to moderate COVID19 POSITIVE Patients | | Apex Laboratories Pvt Ltd | 30-05-2020 | 20200530 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44041 | Not Recruiting | No | | | | 02-06-2020 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | Dr Ramesh Kannan→ | | Room no:5, Department of Pharmacology,Madras medical college, Near Park Town Station, Park Town, Chennai, Tamil Nadu Consultant, Room no:10, Medicine OPD, PM Medical Centre & Ki3(SMO), Tamil Nadu.→ | srkguruvarshan@gmail.com→ | 9677786447→ | Madras Medical College→ | Inclusion criteria: 1. Willing and able to provide written informed consent prior to performing study procedures. <br/ ><br>2. Males and females between the age of 18-50 years. <br/ ><br>3. Mild to moderate COVID-19 associated disease as defined by the WHO. <br/ ><br>4. Hospitalized patient. <br/ ><br>5. Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR. <br/ ><br>6.Illness of any duration and febrile/afebrile. Febrile-defined as temperature â?¥ 36.6 °C armpit, â?¥ 37.2 °C oral, or â?¥ 37.8 °C rectal documented within 48 hours of consent. <br/ ><br>→ | Exclusion criteria: 1. Participation in any other clinical trial of an experimental treatment for COVID-19 <br/ ><br>2.Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 is prohibited < 24 hours prior to study medication initiation <br/ ><br>3.Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) <br/ ><br>4.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) <br/ ><br>5.Pregnant women or women who are breastfeeding <br/ ><br>6.Immunocompromised patients taking medication upon screening <br/ ><br>7.Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive study treatment <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: CLEVIRA tablet twice daily for 14 days: Composition of one CLEVIRA tablet includes extracts namely: <br>Erandakarkati (Carica papaya)-Lf. â?? 100mg,<br>Mahanimba (Melia azedarach)-Lf. â?? 100mg, <br>Kalmegh (Andrographis paniculata)-Herb â?? 100mg, <br>Usira (Vettiverazizanoides)-Rt.â?? 35mg, <br>Patola (Tricosanthusdioica)-Wh.Pl.â?? 35mg, <br>Musta (Cyperusrotundus)-Rz. â?? 35mg, <br>Sunthi (Zingiber officinale)- Rz. â?? 35mg, <br>Maricha (Piper nigrum)-Fr. â?? 35mg, <br>Grismachatraka (Mollugocerviana)-Wh.Pl.â?? 35mg, <br>Guduchi (Tinosporacordifolia)-St. â?? 10mg.<br><br>Given twice daily for 14 days<br>Control Intervention1: Standard treatment group: Treatment given as per WHO/ICMR guidelines<br>→ | a.Time taken for clinical recovery, which is defined as; <br/ ><br>1. Normalization of pyrexia and body pain <br/ ><br>2. Respiratory rate less than 24/minute <br/ ><br>3.Spo2 rate greater than 94% <br/ ><br>4. Relief from cough and maintenance of above for more than 72 hours. <br/ ><br>b.Proportion of patients with swabs negative for COVID19 in RT PCR at day 5, 10 and 15 <br/ ><br>c.Reduction of Viral Load. <br/ ><br>Timepoint: At day 5, day 10 and day 15→ | | 30/06/2020 | | Yes | False | | |
| → | CTRI/2020/05/025485 | 27 January 2021 | the effect of Guduchi (Tinospora cordifolia) as a prophylactic measure among high risk population (Health Care Workers/Containment Zone Population) exposed to COVID-19 | A prospective non-randomized open labeled controlled interventional study on the effect of Guduchi (Tinospora cordifolia) as a prophylactic measure among high risk population (Health Care Workers/Containment Zone Population) exposed to COVID-19 - GPC | | CCRASNIIMH | 30-05-2020 | 20200530 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44052 | Recruiting | No | | | | 29-06-2020 | 5000 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr P V V Prasad→ | | Survey No.314, Revenue Board Colony,
Gaddiannaram, Hyderabad-500036,
Telangana, INDIA → | prasadpeyyala@yahoo.co.in→ | 040-24067388→ | NIIMH-CCRAS, Ministry of AYUSH→ | Inclusion criteria: 1. Adult Male or Female subjects above the age of 18 years to 68 years of age <br/ ><br>2. Subjects who are froma community where at least 1 confirmed case is already identified. <br/ ><br>3. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br>→ | Exclusion criteria: 1. Pregnant and Lactating females <br/ ><br>2. Known cases of uncontrolled Diabetes and Hypertension. <br/ ><br>3. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>5. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>7. Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. <br/ ><br>8. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol <br/ ><br>→ | | Intervention1: GUDUCHI CAPSULE: GUDUCHI CAPSULE-250 mg X 2 capsules b.d, for one month<br>Control Intervention1: Standard Prophylactic Care: Standard Prophylactic Care recommended by Government of Telangana Health authorities<br>→ | 1. Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic CareTimepoint: 0 15 30 45 days→ | | | | Yes | False | | |
| → | CTRI/2020/05/025484 | 27 January 2021 | study on the effect of Chyavanprash Lehyam as a prophylactic measure among high risk population (Health Care Workers/Containment Zone Population) exposed to COVID-19 | A prospective non-randomized open labeled controlled interventional study on the effect of Chyavanprash Lehyam as a prophylactic measure among high risk population (Health Care Workers/Containment Zone Population) exposed to COVID-19 - CPC | | CCRASNIIMH | 30-05-2020 | 20200530 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44055 | Recruiting | No | | | | 03-06-2020 | 5000 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr P V V Prasad→ | | National Institute of Indian Medical Heritage (CCRAS),
Survey No.314, Revenue Board Colony,
Gaddiannaram, Hyderabad-500036, → | prasadpeyyala@yahoo.co.in→ | 040-24067388→ | NIIMH-CCRAS, Ministry of AYUSH→ | Inclusion criteria: 1. Adult Male or Female subjects above the age of 18 years to 68 years <br/ ><br>2. Subjects who are froma community where at least 1 confirmed case is already identified. <br/ ><br>3. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br>→ | Exclusion criteria: 1. Pregnant and Lactating females <br/ ><br>2. Known cases of uncontrolled Diabetes and Hypertension. <br/ ><br>3. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>5. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>7. Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. <br/ ><br>8. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol <br/ ><br>→ | | Intervention1: CHYWANPRASH LEHYAM: CHYWANPRASH LEHYAM-12 g X two times a day <br>(Morning on empty stomach and nigh before going to bed)<br>for one month<br>Control Intervention1: Standard Prophylactic Care: Standard Prophylactic Care recommended by Government of Telangana Health authorities<br>→ | 1. Comparative assessment of occurrence of COVID-19 infection in healthy volunteers in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic CareTimepoint: 0 15 30 45 day→ | | | | Yes | False | | |
| → | CTRI/2020/05/025486 | 27 January 2021 | Dental studentsâ?? perceptions and concerns regarding the current COVID-19 pandemics | COVID-19 Pandemic and its impact on dental students in South India | | Prajna P Nayak | 30-05-2020 | 20200530 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44071 | Not Recruiting | No | | | | 10-06-2020 | 750 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Prajna P Nayak→ | | Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal Pranavam, Ambalpady, Udupi→ | nayak.prajna@manipal.edu→ | 9986176634→ | Manipal Academy of Higher Education→ | Inclusion criteria: those who consent→ | Exclusion criteria: those who do not consent→ | | | perceived stress due to COVID-19Timepoint: at baseline→ | | | | Yes | False | | |
| → | CTRI/2020/05/025487 | 27 January 2021 | Development of Smell based test for identifying COVID-19 infection. | Development of Sensory (Smell based) test to identify COVID-19 positive/negative/ at risk individuals. | | National AgriFood Biotechnology Institute NABI | 30-05-2020 | 20200530 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43586 | Not Recruiting | No | | | | 04-06-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Mahendra Bishnoi→ | | NABI, Sector 81, Distt. Mohali, Punjab → | mbishnoi@gmail.com→ | | National Agri-Food Biotechnology Institute (NABI)→ | Inclusion criteria: 1. Symptomatic COVID19 positive patients, not critically ill or on ventilator, of any age/ sex and their relatives. <br/ ><br>2. At risk individuals in quarantine (relatives and contact of positive individuals, symptomatic or asymptomatic) will also be recruited <br/ ><br>3. As stated above sample size will be 300 initially irrespective of age/sex (no direct ratio) of the individuals <br/ ><br>→ | Exclusion criteria: 1. Critically ill or on ventilator COVID19 positive patients, will be excluded. <br/ ><br>2. The patients on a regular medication with probability of loss of smell and taste sensation will be excluded. Their history of any comorbidity which is related to smell sensation will be taken into account. <br/ ><br>3. Those addicted to the chewing paan and similar materials will be excluded. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Economical, rapid, Make in India, a five-minute odor test that can present the identification, discrimination and thresholds of odor perceptions as a detection of suspected cases of COVID 19. <br/ ><br>Sensory capabilities of COVID positive patients get damaged and thus can be used as tool of diagnosing infected / symptomatic COVID subjectsTimepoint: The new diagnosed COVID positive cases will be tested will our odour test. Whereas those quarantined shall be monitored only after confirmation of their corona test report. <br/ ><br> <br/ ><br>The odour test may be repeated on the recovered COVID patients either immediately or later.→ | | | | Yes | False | | |
| → | CTRI/2020/05/025490 | 27 January 2021 | A Clinical trial to study the efficacy of pH based Integrated SARS Cov-2 Immunity in Human Subjects. | PISCOV TRIAL (pH BASED INTEGRATED SARS CoV-2 )IMMUNITY IN HUMAN SUBJECTS. - PISCOV | | Siddhartha Hospital | 31-05-2020 | 20200531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44042 | Recruiting | No | | | | 07-06-2020 | 110 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Alternation Blinding and masking:Participant and Investigator Blinded | Phase 2/ Phase 3 | India→ | Mr Javed Khan→ | | Department of Rehabilitation
Room No 16
Division-Physiotherapy and Yoga
Siddhartha Hospital
Gulab Rai Marg
Delhi Gate,Agra Department of Rehabilitation
Room No 16
Division-Physiotherapy and Yoga
Siddhartha Hospital
Gulab Rai Marg
Delhi Gate
Agra
→ | agarwalsapna@hotmail.com→ | 9359934773→ | Siddhartha Hospital/ DEI Faculty of Integrated Medicine ,Dayalbagh Educational Institute,→ | Inclusion criteria: 1)High risk healthy contacts of proven Covid-19 patients,2)suspect case of covid-19 for whom testing for Covid-19 could not be performed for any reason or inconclusive,3)cases with Flu like illness residing in a location reporting community transmission of Covid-19 4) cases of Interstitial pneumonia with history of close contact of Covid-19 patient and are covid-19 negative by RT-PCR 5) Healthcare workers in direct care of Covid-19 patients. <br/ ><br> All above presenting within 5 days of exposure→ | Exclusion criteria: Patients suffering from: <br/ ><br>Diabetes,high Blood Pressure,Coronary Heart disease,Heart Failure,Scepticaemia,Cancer,Acute or Chronic Pulmonary disease,Chronic Kidney Disease,Major Nutritional disorder,Immunocompromised State like HIV ,post organ transplant recipient,Pregnant woman,Chronic Liver Disease,Major Neurological Disorder,Anosmia,Acute dysarthria, Acute abdomen or Gastrointestinal emergency,Major Trauma,Pyrexia of Unknown origin and any other life threatening illness which requires dedicated medical care.→ | | Intervention1: 1)Clathrin Inhibition and lethal mutagenesis of virus<br>2)Cholecalciferol<br>3)Azadirachta indica Bark extract concoction<br>4)Arsenicum album<br>5)theoxanthine, theobromine, theaflavins and polyphones in tea<br>6)High pH diet.: After Randomisation ,study group will receive post-exposure-prophylaxis (PoEP ) in the form of interventions by protective factors which raise intracellular pH, for a period of 10 days,tested for blood and urinary pH ,and subsequently tested for Covid-19 by RT-PCR.<br>Doses<br>1.Chlorpromazine-10 mg<br> Frequency -12 hourly<br> Duration-10 days<br> Repeat after -5 weeeks.<br>2.NBE extract concoction<br> Dose 10 ml <br> Frequency-12 hourly<br> Duration-10 days<br>3.Arsenic album 30<br> Dose-5 drops daily<br> Duration 3 days<br> Repeat after 7 days<br> Duration-5 weeks<br>4.sunlight exposure<br> 2 hours daily <br> Duration-5 weeks<br>5.Tea(Theoxanthine )<br> Dose - 50 ml<br> Frequency-6 hourly<br> Duration -5 weeks<br>6.High pH diet.<br>Control Intervention1: Monitoring of health parameters and the standard treatment protocol as per ICMR guidelines.: After randomisation,those who will be in control group will be monitored for vital health parameters ,will be treated as per guidelines of ICMR for high risk Covid-19 suspects and subsequently be tested for blood and urinary pH and Covid-19 RT-PCR.<br>→ | Full(100%) protection from Covid-19 infection and Disease.Timepoint: 5 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/025488 | 27 January 2021 | Clinical study on Guduchi Ghana Vati as a preventive remedy in pandemic of COVID-19 | An Open label, Multi centric, Randomized, Comparative, Prospective, Interventional Community based Clinical Study to Evaluate Safety and Efficacy of Guduchi Ghana Vati as a Preventive Remedy on Healthy Individuals in Pandemic of COVID-19 - GGVC19 | | National Institute of Ayurveda | 31-05-2020 | 20200531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44062 | Not Recruiting | No | | | | 03-06-2020 | 12000 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr PawanKumar Godatwar→ | | Department of Roganidana and Vikriti Vijnana, OPD No. 5, Ground Floor, Madhav Vilas Palace Jorawar Singh Gate Amer Road Jaipur Rajasthan Jaipur, RAJASTHAN
→ | gpawankumar@rediffmail.com→ | 9314502834→ | National Institute of Ayurveda, Jaipur→ | Inclusion criteria: 1. Healthy, Male or Female subjects between the age group of 18 years to 70 years (both inclusive). Healthy individuals will be considered as those who do not have any acute medical condition or chronic medical/surgical condition that requires either immediate or continuous medical monitoring or treatment. <br/ ><br>2. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study. <br/ ><br>→ | Exclusion criteria: 1. Pregnant and Lactating females <br/ ><br>2. Subjects who have been confirmed of having COVID-19 and have been isolated for its treatment. Subjects having recently suffered and recovered of COVID-19 will also be excluded from the study <br/ ><br>3. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. <br/ ><br>5. Subjects taking steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study. <br/ ><br>7. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol <br/ ><br>→ | | Intervention1: Guduchi Ghana Vati: Each Guduchi Ghana Vati contains Guduchi Ghana (Tinospora cordifolia) 500 mg with preservatives and excipients<br><br>Dosage and Treatment Duration: <br>2 tablets twice daily orally after meals with water for 45 days <br><br>Control Intervention1: NIL: Dosage and Treatment Duration: Subjects in this group will not be given any medicine<br>→ | Comparative assessment of incidence of COVID-19 in subjects taking GUDUCHI GHANA VATI and those not taking it over a period of 45 daysTimepoint: (day-5, day 0, day-15, day-30, day-45)→ | | | | Yes | False | | |
| → | CTRI/2020/05/025491 | 27 January 2021 | The efficacy of Homeopathic medicines in the prevention of COVID-19 in Quarantined or Exposed Individuals | Double blind, placebo controlled, multi-centric,
cluster randomized study to evaluate the efficacy of Homeopathic medicines in
the prevention of COVID-19 in Quarantined or Exposed Individuals | | Life Force Foundation Trust | 31-05-2020 | 20200531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44065 | Recruiting | No | | | | 08-06-2020 | 1000 | Interventional | Cluster Randomized Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Outcome Assessor Blinded | Phase 2 | India→ | Dr Rajesh Shah→ | | 412, krushal commercial complex, 4th floor, above shoppers stop, G.M.Road, Chembur,
Mumbai. 400089 → | sanjivak@gmail.com→ | 02266888888→ | Life Force Foundation Trust→ | Inclusion criteria: Quarantined individuals <br/ ><br>Covid19 exposure risk groups (For example, police, hospital staff, etc.) <br/ ><br>The participant is willing and able to give informed consent for participation in the study <br/ ><br>Agrees not to self-medicate with potential antivirals→ | Exclusion criteria: i. Subjects who are detected SARS-CoV-2 positive at baseline ii. Inability to be followed up for the trial period <br/ ><br>iii. Subjects who are scheduled to receive any other investigational drug during the study.→ | | Intervention1: 1. Arsenic Album 30c potency <br>2. Bryonia alba 30c potency 3. Camphora 1M potency <br>4. Coronavirus related nosodes (30c potency) <br>5. Matching Placebo pills size 30: six pills two times a day for 3 days orally<br>Intervention2: Homeopathy medicine: 1. Arsenic Album 30c potency<br>2. Bryonia alba 30c potency<br>3. Camphora 1M potency<br>4. Coronavirus related nosodes (30c potency)<br>5. Matching Placebo pills<br>→ | a. Number of people turning symptomatic <br/ ><br>Number of people turning Covid19 positive <br/ ><br>c. Number of people recovering after turning positive <br/ ><br>d. Number of deaths, if any, if get infectionTimepoint: Baseline, week 2 and week 4→ | | | | Yes | False | | |
| → | CTRI/2020/05/025489 | 27 January 2021 | To compare two intubation scopes for securing the airway during COVID pandemic in patients undergoing surgery | Comparison of Mc Grath-MAC and C-MAC video laryngoscopes for intubation in patients with normal airway by donned anesthesiologists using an intubation box during COVID pandemic: a prospective randomised study. | | AIIMS | 31-05-2020 | 20200531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43376 | Recruiting | No | | | | 01-06-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | Nishkarsh Gupta→ | | Room No 139 DRBRAIRCH, Ansari Nagar South DELHI 110029 ,India → | drnishkarsh@rediffmail.com→ | | AIMS, Department of Onco-Anesthesiology and Palliative Medicine→ | Inclusion criteria: Inclusion criteria â?? adult patients (18-70 years), ASA I/II undergoing elective surgery under general anesthesia.→ | Exclusion criteria: a) The presence of predictors of difficult bag and mask ventilation (presence of beard, obese with BMI >35, snoring, edentulous, intraoral tumors, receding chin etc.) and intubation, including decreased inter-incisor distance ( <2 cm), short thyromental distance ( <6 cm), and reduced neck extension ( <80° from neck flexion), cervical spine instability, or risk of pulmonary aspiration. <br/ ><br>b) Patient refusal to participate in the study <br/ ><br>c) ASA III or more <br/ ><br>→ | Health Condition 1: C00-D49- Neoplasms
→ | Intervention1: CMAC Videolaryngosocpe (VL): Intubation will be done using CMAC VL by an anesthesiologist using COVID intubation box<br>Control Intervention1: Mc Grath MAC videolaryngoscope: Intubation will be done using Mc Grath MAC VL by an anesthesiologist using COVID intubation box<br>→ | time to intubationTimepoint: immediately after intubation→ | | | | Yes | False | | |
| → | CTRI/2020/05/025492 | 27 January 2021 | Impact of tele-consultation for following up newborns during COVID-19 pandemic | Impact of teleconsultation for neonatal follow-up during COVID-19 pandemic: A randomized controlled trial | | JIPMER Intramural fund | 31-05-2020 | 20200531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43382 | Not Recruiting | No | | | | 15-06-2020 | 2978 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Sindhu Sivanandan→ | | Jawaharlal Institute of Postgraduate Medical Education and Research,
Jipmer Campus Rd, Gorimedu,
Dhanvantari Nagar,
Puducherry, 605006. JIPMER, Puducherry→ | drsindhusivanandan@gmail.com→ | 9968935020→ | Department of Neonatology, Jawaharlal Institute of Postgraduate Medical Education and Research→ | Inclusion criteria: Neonates with gestational age at birth greater than or equal to 34 weeks <br/ ><br>Delivered in JIPMER hospital <br/ ><br>Discharged home within the first week of life <br/ ><br>→ | Exclusion criteria: 1. Need for NICU stay for 7 days or more <br/ ><br>2. Major congenital anomalies <br/ ><br>3. Postnatal morbidities (respiratory distress syndrome, neonatal sepsis, need for ventilation more than 24 hours, moderate or severe hypoxic iscahemic encephalopathy etc) requiring enrollment and follow up in high risk follow up clinic of JIPMER as per unit policy <br/ ><br>4. Parents who do not have a telephone or mobile services to enable tele consultation <br/ ><br>5. Unwilling to provide consent <br/ ><br>→ | | Intervention1: Tele-consultation arm: Caregivers of enrolled infants being discharged from hospital shall participate in a teleconsultation visit with neonatal providers within one week of discharge. <br>Mode of teleconsultation: Telephonic calls <br>Providers: The teleconsultation shall be provided by neonatal consultant or neonatology senior residents at fixed times using a dedicated mobile phone or landline at fixed time 10 am-12 noon. <br>Calls from parents in case of emergencies shall be answered 24x7 using a dedicated mobile phone for this purpose. <br>Frequency of teleconsultation- 3-7 days post discharge, 14 days of life and day 28 of life. Late preterm neonates shall receive additional call at 28 days of corrected age. Additional follow up teleconsultation will be provided if required.<br>Obtaining parental satisfaction: Caregivers shall complete an anonymous post-visit satisfaction survey on a scale of 0-5 at the end of the study period (28 days postnatal age) or 40 weeks corrected age whichever is later on three aspects; comfort with the physician during teleconsultation, whether not their questions were answered and their overall satisfaction with the visit<br><br>Control Intervention1: Standard arm: At the time of discharge these neonates shall be advised to follow up with their local paediatrician or local hospital for any concerns. Some babies may be advised another visit with local practitioner for follow up of jaundice or feeding issues. In order to measure the outcome, the standard care group shall receive one telephonic call at the end of 28 days of life for term neonates and at 4 weeks corrected age for late preterm neonates to identify the need the hospitalisation or emergency care visit and to enquire the status of the neonate.<br><br><br><br>→ | Need for emergency room visit or re-hospitalizationTimepoint: At 28 days of life for term neonates and at 4 weeks corrected age for late preterm neonates→ | | | | Yes | False | | |
| → | CTRI/2020/05/025493 | 27 January 2021 | Effect of Ayurvedic medicine in the Prophylaxis for COVID-19 of Police personnel Dept of AYUSH, TS & CCRAS- NIIMH, Hyderabad. | Prospective Open label Observational study on the Effect of Chyawanprash, Samshamani vati & Haritaki (Raksha Kit) as Prophylactic measure among police personnel working in the vicinity of COVID -19 facilities | | Department of AYUSH Govt of Telangana Ayurveda CCRASNIIMH Hyderabad | 31-05-2020 | 20200531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44177 | Not Recruiting | No | | | | 15-06-2020 | 1500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Dr Madikonda Praveen kumar→ | | Department of Panchakarma,
Dr. B.R.K.R. Government Ayurvedic College SR Nagar Hyderabad
→ | pkmadikonda@gmail.com→ | 9849271601→ | Dr. B.R.K.R. Government Ayurvedic College→ | Inclusion criteria: 2. Police personnel working within the facilities of COVID-19 duties. <br/ ><br>3. Subjects who are from a community where at least 1 confirmed case is already identified. <br/ ><br>4. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br>→ | Exclusion criteria: 1. Pregnant and Lactating females. <br/ ><br>2. Known cases of uncontrolled Diabetes and Hypertension. <br/ ><br>3. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>5. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>7. Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. <br/ ><br>8. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol <br/ ><br> <br/ ><br>→ | | | Comparative assessment of occurrence of COVID-19 infection in healthy volunteers vis Police personal in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic CareTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/05/025494 | 27 January 2021 | Mental impact of SARS Covid-19 disease outbreaks among suspects coming to AIIMS Rishikesh, their close contacts, and associated healthcare providers | "To assess the mental impact of SARS-CoV-2 (Covid-19 disease) outbreaks among suspects coming to AIIMS Rishikesh, their close contacts, and associated healthcare providers â?? a longitudinal study" | | AIIMS Rishikesh | 31-05-2020 | 20200531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44179 | Not Recruiting | No | | | | 10-06-2020 | 3000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Prasan Kumar Panda→ | | Department of General Medicine,Sixth Floor, College Block, AIIMS Rishikesh → | prasan.med@aiimsrishiekesh.edu.in→ | 9868999488→ | AIIMS Rishikesh→ | Inclusion criteria: 1.All previously suspected cases [tested positive or negative] and new or currently suspected cases coming to AIIMS Rishikesh with their close contacts [family and friends; records starting from 8th December 2019 <br/ ><br>2.All healthcare workers directly related [treating or managing the patient] in AIIMS Rishikesh <br/ ><br>3. All healthcare workers not directly related to the patient but in same dept, AIIMS Rishikesh <br/ ><br>→ | Exclusion criteria: 1.Suspected cases who have come from other countries <br/ ><br>Methodology- The study will be conducted out at AIIMS, Rishikesh. The study will evaluate the fear, stress, and depression levels according to PSS 10 and DASS 21 questionnaires and all levels will be scaled according to the Likert scale. Subjects of the study will be givenprinted copy or soft copy of the questionnaire to record their responses. Patients will be followed up every 14 days till outbreak is over or 6-months whichever is longer. <br/ ><br>PSS 10 <br/ ><br>1.In the last month, how often have you been upset because of something that happened unexpectedly? <br/ ><br>2.In the last month, how often have you felt that you were unable to control important things in life? <br/ ><br>3.In the last month how often did you feel nervous and stressed? <br/ ><br>4.In the last month, how often have you felt confident about your ability to handle your personal problems? <br/ ><br>5.In the last month, how often have you felt things were going your way? <br/ ><br>6.In the last month how often have you found that you could not cope with all the things you had to do? <br/ ><br>7.In the last month, how often have you been able to control irritations in your life <br/ ><br>8.In the last month, how often have you felt that you were on top of things? <br/ ><br>9.In the last month, how often have you been angered because of things that were outside of your control? <br/ ><br>10.In the last month how often have you felt difficulties were piling up so high that you could not overcome them? <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To estimate the fear, stress, and depression levels according to PSS 10 and DASS 21 questionnaires and according to the Likert scaleTimepoint: base line, and 14 days interval→ | | | | Yes | False | | |
| → | CTRI/2020/05/025496 | 27 January 2021 | Study to observe safety of CNV01 homeopathy preparation in healthy volunteers | Study of Homeopathic preparation (CVN01 nosode of COVID-19 virus)
to evaluate safety in healthy volunteers
| | Life Force Foundation Trust | 31-05-2020 | 20200531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44192 | Recruiting | No | | | | 08-06-2020 | 10 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 1 | India→ | Dr Rajesh Shah→ | | 412, krushal commercial complex, 4th floor, above shoppers stop, G.M.Road, Chembur, Mumbai. → | sanjivak@gmail.com→ | 02266888888→ | Life Force Foundation Trust→ | Inclusion criteria: Healthy individuals with no major untreated diseases and normal routine laboratory parameters during the screening <br/ ><br>Able to be informed of the nature of the study and willing to give written informed consent <br/ ><br>→ | Exclusion criteria: 1. Any known disease or condition (such as Cancer) which might compromise the general health or comorbid conditions <br/ ><br>2. Subjects who have been confirmed of having COVID-19 and have been isolated for its treatment. <br/ ><br>3. Subjects having recently suffered and recovered of COVID-19 will also be excluded from the study <br/ ><br>4. Persons having known history of allergies, food hypersensitivity, etc. <br/ ><br>5. Women during pregnancy, puerperium and while breast-feeding. <br/ ><br>6. Participation in another clinical trial during the last 6 months <br/ ><br>7. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol <br/ ><br>→ | | Intervention1: nil: nil<br>→ | Safety measure in terms of investigations (PCR) blood parametersTimepoint: at baseline, 17th day and follow-up at 30th day→ | | | | Yes | False | | |
| → | CTRI/2020/05/025495 | 27 January 2021 | Screening of healthcare workers, Doctors and Nurses working in Covid-19 wards using a continous wearable watch device | Continous wearable device based Monitoring of Healthcare Professionals supporting Covid-19 patients for early screening of Covid-19 related symptoms | | Tata Consultancy Services India | 31-05-2020 | 20200531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44209 | Not Recruiting | No | | | | 10-06-2020 | 30 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Kayapanda Mandanna→ | | Fortis hospital,Room 417,
Department of Cardiac Surgery,
730, Anandpur,
Kolkata → | kmmandana@gmail.com→ | 09831112359→ | Fortis hospitals , Kolkata→ | Inclusion criteria: All healthcare workers , assigned to Covid ward / ICU duties, includes Doctors and Nurses→ | Exclusion criteria: Persons not involved in Covid -19 care wards/ICU→ | | Control Intervention1: nil: nil<br>→ | Fortis will distribute the wearable device Watch called ( Empatica E4 ) provided by TCS to consenting volunteers. The volunteer will wear the watch continously for 2 weeks , wherein the following metadata will be recorded. Heart rate, Spo2, Body temperature, height, weight, Blood pressure( recorded manually ), will be recorded against the USER ID provided to TCS.Timepoint: Data to be analysed at Baseline, at 2 weeks, at 4 weeks and at 6 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/05/025497 | 27 January 2021 | Knowledge, attitudes, and practices towards COVID-19 among Indian residents during the period of the COVID-19 outbreak | Knowledge, attitudes, and practices towards COVID-19 among Indian residents during the period of the COVID-19 outbreak: an online cross-sectional survey | | Dr Abhishek Pandey | 31-05-2020 | 20200531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44257 | Not Recruiting | No | | | | 14-06-2020 | 480 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Abhishek Pandey→ | | Department of Medicine
Institute of Medical Sciences
Banaras Hindu University
Varanasi 221005
India → | abhishek.pandey1@bhu.ac.in→ | 7081598111→ | Institute of Medical Sciences, Banaras Hindu University→ | Inclusion criteria: 1.The willing Indian residents who participate and complete the online survey <br/ ><br>→ | Exclusion criteria: 1. Respondents with incomplete response to questionnaire <br/ ><br>2. Respondents who have not given consent for online survey→ | | | To assess Knowledge, attitudes, and practices towards COVID-19Timepoint: AT BASELINE→ | | | | Yes | False | | |
| → | CTRI/2020/06/025523 | 27 January 2021 | The effect of meditation on well-being of SARS-Cov-2 infected patients. | The effect of meditation and breathing exercises on well- being of patients with SARS-Cov-2 infection under institutional isolation â?? A Randomized controlled trial | | NCI jhajjar | 01-06-2020 | 20200601 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43396 | Not Recruiting | No | | | | 08-06-2020 | 84 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Anuja Pandit→ | | Department of onco anaesthesia and palliative medicine
All India Institute of Medical Sciences
New Delhi → | anujapandit@yahoo.co.in→ | 9710030457→ | National Cancer Institute, Jhajjar, All India Institute of Medical Sciences→ | Inclusion criteria: Asymptomatic/ mildly symptomatic positive cases of SARS CoV-2 admitted in NCI, isolation facility <br/ ><br> <br/ ><br>Patients who give informed consent→ | Exclusion criteria: Patients who do not understand Hindi or English→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Meditation and breathing exercises: Patient will be asked to do Anulom vilom/nadishodhan pranayama which involves breathing through alternative nostrils for 5-10 minutes three times a day for 7 days and conservative management will be done same as for all asymptomatic or mildly symptomatic Covid infected patients<br>Control Intervention1: No intervention: Conservative management of asymptomatic or mildly symptomatic covid infected patients as for intervention group<br>→ | To compare depression, anxiety and stress levels in patients doing breathing exercises and meditation during institutional isolation with patients not doing the same. it will be assessed using DASS21 questionnaire which includes 21 questions that assess the three parameters of depression, anxiety and stressTimepoint: DASS21 score will be compared of both the groups control vs intervention. After7 days of intervention that is meditation DASS21 will be assessed.→ | | 21/08/2020 | | Yes | False | | |
| → | CTRI/2020/06/025526 | 27 January 2021 | To observe the impact of Ayurveda Kwath in Healthy and Suspected persons for COVID-19 | A Cross Sectional Study to observe the Health Status of apparently Healthy/suspected persons and receiving an Ayurveda Kwath for Immuno-modulation | | Dr SR Rajasthan Ayurved University | 01-06-2020 | 20200601 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44182 | Not Recruiting | No | | | | 10-06-2020 | 500 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Prof Govind Sahay Shukla→ | | Room No.- 33, University College of Ayurved, Dr. S.R. Rajasthan Ayurved University, Karwar, Naguar road, Jodhpur(Rajasthan) → | dr.govindshukla@yahoo.com→ | 8769058254→ | University College of Ayurved, Dr. S.R. Rajasthan Ayurved University, Jodhpur→ | Inclusion criteria: 1) Persons willing to receive Ayurvedic decoction. <br/ ><br>2) Willingness to participate in survey work. <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1) Persons not willing to interact with survey team. <br/ ><br>2) Irregular intake of decoction.→ | | Intervention1: NIL: <br>NIL<br>→ | To prevent the spread of infection in healthy persons residing in containment zone and / or other areas.Timepoint: One Month→ | | | | Yes | False | | |
| → | CTRI/2020/06/025522 | 27 January 2021 | Comparison of two devices for intubation in COVID simulated scenario in mannequin | Comparison of King vision Videolaryngoscope channelled blade and Tuoren Videolaryngoscope non-channelled blade in a simulated COVID intubation scenario by novices and experienced anaesthesiologists: a prospective randomized crossover mannequin study. | | Research Section AIIMS | 01-06-2020 | 20200601 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43438 | Not Recruiting | No | | | | 02-06-2020 | 50 | Interventional | Randomized, Crossover Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Anju Gupta→ | | Department of Anesthesiology, Pain Medicine and Critical Care → | dranjugupta2009@rediffmail.com→ | 9911573371→ | AIIMS→ | Inclusion criteria: Any anesthesiologist with atleast year experience in anesthesia and has performed more than 10 intubations with a VL earlier will be included. Any other medical personnel belonging to any other clinical domain (medicine, emergency medicine, cardiology, neurology, endocrinology etc) and being deployed to take care of suspected/ confirmed COVID19 patients.→ | Exclusion criteria: Those who donot consent→ | | Intervention1: Intubation using Touren non channeled videolaryngosocpe with a styletted tube: The intubation will be done by anesthesiologist and non anesthesiologist in a mannequin in PPE using Touren VL and then they will be crossed over to the other group.<br>Control Intervention1: Intubation using King Vision channeled videolaryngosocpe: The intubation will be done by anesthesiologist and non anesthesiologist in a mannequin in PPE with King vision VLthen they will be crossed over to the other group.<br>→ | Time to intubationTimepoint: Time to intubation→ | | | | Yes | False | | |
| → | CTRI/2020/06/025527 | 27 January 2021 | Clinical trial on Immunity and antiviral for quarantine patients of COVID-19 | â??A Prospective, Open label, Randomized-controlled study to evaluate the efficacy and safety of Amrta Karuna Syrup in mildly symptomatic COVID- 19 patientsâ?? | | Vopec Pharmaceuticals Pvt Ltd | 01-06-2020 | 20200601 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43968 | Not Recruiting | No | | | | 01-06-2020 | 42 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Post Marketing Surveillance | India→ | DrDinesh→ | | B-13, Mogappair Industrial Estate,
Mogappair West,
Chennai → | rnd@vopecpharma.com→ | 9952063729→ | Vopec Pharmaceuticals (P) Ltd→ | Inclusion criteria: 1.Subjects age group 18 - 65 years both gender <br/ ><br>2.Patients diagnosed with COVID-19 positive mild symptomatic patients (Confirmed by RTPCR) - Patients with uncomplicated upper respiratory infection <br/ ><br> a. Spo2 >94% in room air <br/ ><br> b. Respiratory rate <24 per min <br/ ><br> c. No evidence of hypoxaemia or <br/ ><br> breathlessness <br/ ><br>3. Subjects willing to give a written informed consent and come for a regular follow up <br/ ><br>4. Subject willing to abide by and comply with the study protocol <br/ ><br>→ | Exclusion criteria: i.Presence of acute hypoxic respiratory failure. <br/ ><br>ii.Intensive care unit (ICU) stay. <br/ ><br>iii. Patients who need mechanical ventilation. <br/ ><br>iv.Category 6 or 5 based on modified 7-category ordinal scale of clinical status→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Amrta Karuna Syrup: Dosage Form: syrup <br>Dose: 15 ml<br>Frequency: 2 times daily after meal <br>Route of administration: oral<br>Duration of therapy: 14 days<br><br>Control Intervention1: Standard treatment as per<br>hospital protocol for COVID 19: Cases of COVID 19 shall be<br>treated with standard treatment<br>as per hospital protocol for<br>COVID 19 until the recovery<br>Day 1 to Day 14 Route : Orally<br>twice daily after meal As per the<br>Hospital guidelines. Route :<br>Orally Dose: As per standard<br>Hospital policy<br>→ | To Evaluate The Safety And Efficacy Of Amrta Karuna syrup In mildly symptomatic COVID- 19 patients <br/ ><br>Timepoint: Day 0 to 14→ | | | | Yes | False | | |
| → | CTRI/2020/06/025525 | 27 January 2021 | Guduchi Ghanavati as a prophylactic measure among population at high risk to SARS-CoV-2 exposure | A prospective non-randomised open label controlled interventional study on the effect of Guduchi Ghanavati as a prophylactic measure among population at high risk to SARS-CoV-2 exposure | | Institute for Post Graduate Teaching and Research in Ayurveda | 01-06-2020 | 20200601 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44240 | Not Recruiting | No | | | | 09-06-2020 | 20000 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Kalpesh Panara→ | | Department of Dravyaguna
IPGTRA
Jamnagar → | kbpanara@gmail.com→ | | Institute for Post Graduate Teaching and Research in Ayurveda→ | Inclusion criteria: Subjects at high risk of exposure to COVID 19 infection such as Health care workers involved in treatment of COVID19 cases <br/ ><br>Frontline workers of city where COVID 19 cases detected <br/ ><br>Family members of COVID19 cases or direct contact <br/ ><br>People in quarantine <br/ ><br>People in containment zones <br/ ><br>Subjects who are ready to provide written or digital informed consent and who are willing to participate→ | Exclusion criteria: Pregnant and Lactating female <br/ ><br>COVID 19 positive cases <br/ ><br>Known cases of uncontrolled Diabetes and Hypertension or any other systemic uncontrolled conditions <br/ ><br>Having immune compromised status like HIV Hepatitis Tuberculosis Cancer etc <br/ ><br>Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>Subjects taking Steroid treatment and or any kind of immunosuppressive therapy→ | | Intervention1: Guduchi Ghanavati: 2 Pills of 250mg each <br>Orally twice a day with water <br>For 28 days<br>Control Intervention1: No treatment in control group: As this is prophylaxis study no treatment arm is selected in this study as control group<br>→ | Incidence rate of COVID 19 infectionTimepoint: 0 14 28 days→ | | | | Yes | False | | |
| → | CTRI/2020/06/025557 | 27 January 2021 | A clinical study of Ayurvedic formulations in the treatment of Mild to Moderate COVID-19 patients | A Randomized, Open Label, Parallel Efficacy, Active Control, Multi-Centre Exploratory Drug Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients | | Ministry Of Ayush | 02-06-2020 | 20200602 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43812 | Recruiting | No | | | | 11-06-2020 | 420 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | DR ARVIND CHOPRA→ | | 11, HERMES ELEGANCE, 1988, CONVENT STREET,
CAMP. PUNE
MAHARASHTRA 11, HERMES ELEGANCE,
1988, CONVENT STREET,
CAMP. PUNE→ | crdp5624@gmail.com→ | 91-20-26344099→ | CENTER FOR RHEUMATIC DISEASES→ | Inclusion criteria: i.Typical clinical presentation of acute onset febrile illness with cough and a RT_PCR based laboratory confirmation test for COVID-19 <br/ ><br>ii. Patients with either sex, 20 to 69 years age <br/ ><br>iii. Patients with mild to moderate patients <br/ ><br>iv. All patients must agree not to share medication <br/ ><br>v. Patients willing to participate and sign an informed consent→ | Exclusion criteria: Patients suffering from severe COVID-19 Disease as judged by a physician and fulfilling at least two of the following three criteria (i) Respiratory distress at room ambience (â?¥30 breaths per min) (ii) Oxygen saturation at rest â?¤93% (peripheral digital arterial oxymetry) and requiring oxygen support for over one hour to normalize (iii) Any of the known COVID-19 complications and emergency procedures which may require shift/admission in intensive care unit such as respiratory failure, adult respiratory distress syndrome, requirement of oxygen support for over 1 hour, requirement of mechanical ventilation, septic shock, or severe non-respiratory organ dysfunction or failure. (Adapted and modified from the reference: Yang Liu et al. Lancet Infect Dis 2020, 2020 https://doi.org/10.1016/ S1473-3099(20)30232-2) <br/ ><br>ii. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study <br/ ><br>iii. History of immunosuppression: solid organ or bone marrow transplant, use of immunosuppressive antimetabolic and biologic agents, intrinsic immunodeficiencies, HIV infection. <br/ ><br>iv. Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. <br/ ><br>v. Patients on parenteral nutrition <br/ ><br>vi. Patients with known sensitivity or contraindication to any of the ingredients of study medication <br/ ><br> <br/ ><br>vii. History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.) <br/ ><br>viii. Patients who are likely to worsen or planed ICU admission or ventilator support due to any reason <br/ ><br>ix. Pregnancy and lactation <br/ ><br>x. Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19 <br/ ><br>xi. Participation in any other clinical trial of an experimental agent treatment for COVID-19 <br/ ><br>xii. Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind. <br/ ><br>xiii. Physician decision that involvement in the study is not in the patient´s best interest <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: i)AYUSH-64<br>ii)Yashtimadhu<br>iii)Sanshamani Vati Plus: i)AYUSH-64, 500 mg tablet, 2 tablets bid, <br>ii)Yashtimadhu 300 mg tablet, 2 tablets bid<br>iii)Sanshamani Vati Plus,Each tablet to contain 300 mg Guduchi plus 75 mg Pippali, 2 tablets<br>bid<br>Each of these 3 Ayurvedic formulations will be assessed in 3 separate drug trial studies with a randomized two arm active controlled design using common protocol and methods<br>Control Intervention1: Standard Care as per the Ministry of Health and family welfare guidelines for COVID19 and updated.: There is no specific therapy for COVID-19. All patients will be treated under strict supervision of a qualified physician. Triage will be performed in all patients on initial diagnosis to assess severity and repeated as per clinical judgement. Patients with moderate disease will need to be treated as inpatients. Taking preventive measures to avoid spread of infection from the patient is essential including PPE and suitable masks. However symptomatic treatment will be given in Mild and Moderate cases to treat fever and cough. Empiric antimicrobials will be used to treat all likely pathogens causing uncomplicated pneumonia and SARI. Uncomplicated cases with mild hypoxia may need supplemental oxygen. Hydroxychloroquine and macrolide maybe considered as an off label agent in patients with severe progressive disease. Steroids are not recommended for use in mild and moderate disease. Patients with severe disease and requiring intensive care will be withdrawn from the study and continued management as per the guidelines<br>→ | a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery (see criteria below)] <br/ ><br>b) Proportion of patients showing clinical recoveryâ?? <br/ ><br>Timepoint: Baseline, Daily assessment during symptomatic phase or hospitalization phase till complete recovery, WEEK 4, week 8, and study completion week 12→ | | | | Yes | False | | |
| → | CTRI/2020/06/025530 | 27 January 2021 | Using Homeopathic Combinations for Prevention and Treatment of Viral Fevers including COVID19 | Evaluating the Efficacy of Homeopathic Combinations for Prophylaxis and Treatment of Viral Fevers including COVID19 | | Cancer Aid Society | 02-06-2020 | 20200602 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43305 | Not Recruiting | No | | | | 18-06-2020 | 10000 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Piyush Gupta→ | | 402,4th Floor Sunshine Court Phase 2, 66C Prag Narain Road, 404, 4th Floor Sunshine Court Phase 2, 66C Prag Narain Road,→ | drgupta_hema@yahoo.co.in→ | 8318457904→ | Homeopathic Drug Research Institute→ | Inclusion criteria: All the Sanitary Workers and other Staff of Lucknow Nagar Nigam→ | Exclusion criteria: Patients of COVID19→ | | Intervention1: Use of Homeopathic Medicines in Prophylaxis/ Treatment of Viral Fevers/ COVID19: Combination of Aconite 30, Arsenic Album 30, Allium Cepa 30, Influenzum 30, Gelsmium 30, Eupatorium 30, Echinacia 0, Thuja 0<br>→ | How many people get Viral Fever/ COVID19 after taking the MedicineTimepoint: 6 Weeks→ | | 28/10/2020 | | Yes | False | | |
| → | CTRI/2020/06/025556 | 27 January 2021 | A clinical trial to know the effect of Virulina® along with standard treatment in covid 19 positive patients. | A double blind, placebo controlled, randomized clinical trial to evaluate the efficacy and safety of the Virulina® along with standard treatment as per hospital protocol for the treatment of novel coronavirus (COVID-19). | | Natural Solutions | 02-06-2020 | 20200602 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44144 | Not Recruiting | No | | | | 15-06-2020 | 30 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Anil Sharma→ | | Natural solutions
Dept. of Internal medicine
Ayurvedic section
Anjani complex B 14
Pereira Hill Road Off A K Road
Near Western Express Metro
Station Gate No 7
Andheri East Mumbai → | info@pharexcelconsulting.com→ | 9878551428→ | Pharexcel Consulting→ | Inclusion criteria: 1. Either male or female of age range 18-70 years. <br/ ><br>2. Recent history of contact with Covid-19 positive people and are advised to be quarantined or has symptoms which include cough, fever with or without chills and difficulty in breathing (Time interval between symptoms onset and randomization to be not more than 7 days) <br/ ><br>3. Patients with laboratory confirmation of infection with SAARS-CoV-2 by positive RT-PCR (within 48 hrs prior to randomization) <br/ ><br>Subjects willing to give written informed consent and come for a regular follow up <br/ ><br>4. Subjects willing to abide by and comply with the study protocol <br/ ><br>→ | Exclusion criteria: 1. Patients presenting severe multisystemic symptoms compatible with advanced Covid-19 and intercurrent acute or severe chronic diseases (i.e. active cancer). <br/ ><br>2. Presence of acute hypoxic respiratory failure <br/ ><br>3. Requires Intensive care unit (ICU) care for management of ongoing clinical status <br/ ><br>4. Severe infection, defined as need for invasive or non- invasive ventilator support <br/ ><br>5. Inability to intake or tolerate oral medication <br/ ><br>6. Category 6 or 5 based on modified 7-category ordinal <br/ ><br>scale of clinical status <br/ ><br>7. Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission <br/ ><br>8. Pregnant subjects→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Virulina® along with standard treatment protocol: Dose: 3gm, three times a day<br>Dosage form: Powder <br>Route of Administration: Oral <br>Time of Administration: morning, afternoon and evening<br>Duration of treatment: 14 days<br>Control Intervention1: Placebo along with standard treatment protocol: Dose: 3gm, three times a day<br>Dosage form: Powder <br>Route of Administration: Oral <br>Time of Administration: morning, afternoon and evening<br>Duration of treatment: 14 days<br>→ | Time until cessation of oral shedding of SAARS-CoV- 2 virus (Time in days from randomization to a negative SAARS-Cov-2 RT-PCR result of both oropharyngeal swab and nasopharyngeal swab). <br/ ><br>Time point-Up to 14 days <br/ ><br>- Clinical cure based on Clinicianâ??s assessment of symptoms which include cough relief, recovery from fever and difficulty in breathing for the period they are in quarantine. (For those patients who presented with clinical signs and symptoms at baseline).Timepoint: Day 1, Day 7 and Day 14→ | | 21/08/2020 | | Yes | False | | |
| → | CTRI/2020/06/025558 | 27 January 2021 | Homoeopathic Medicines Bryonia alba 30C as a Prophylaxis for COVID-19 | Effectiveness of Bryonia Alba 30C in the prevention of COVID-19 in Quarantine individual: Double Blind, Randomised Placebo Controlled Trial | | Principal Aarogya Homoeopathic Medical College and Hospital | 02-06-2020 | 20200602 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43411 | Not Recruiting | No | | | | 15-06-2020 | 300 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded | Phase 4 | India→ | Prof Dr Puneet R Shah→ | | Aarogya Homoeopathic Medical College and Hospital, Shri Vinayak Education Campus, Naila, Near Kanota, Agra Road, Jaipur Aarogya Homoeopathic Medical College and Hospital, Shri Vinayak Education Campus, Naila, Near Kanota, Agra Road, J→ | drdannih@gmail.com→ | 9636452755→ | Aarogya Homoeopathic Medical College and Hospital→ | Inclusion criteria: Persons in Quarantine centres with history of exposure, with all the following shall be included: <br/ ><br>1. Suspected cases of COVID-19 who are asymptomatic. <br/ ><br>2. Age 18 years and above and all genders <br/ ><br>3. Willing to give written informed consent. <br/ ><br>→ | Exclusion criteria: 1. Pregnant women or lactating mothers <br/ ><br>2. Immunocompromised individuals on basis of medical history <br/ ><br>3. Symptomatic (similar to COVID-19) cases at quarantine facility. <br/ ><br>4. Rapidly progressive respiratory failure and sepsis. <br/ ><br>5. Aged below 18 yrs <br/ ><br>6. Not willing to give informed consent <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: Bryonia alba 30C: Another half or 50 percentage of cases will receive Bryonia alba 30C as experiment arm.<br>Homoeopathy intervention shall be taken twice (6 pills) daily of prescribed Homoeopathic medicine, on empty stomach for seven days along with usual standard care of IPC.<br>Control Intervention1: Identical Placebo: Placebo shall be taken twice (6 pills) daily on empty stomach for seven days.<br>→ | The results of the study will be able to determine the prophylactic effect of Homoeopathic Medicines in COVId-19 cases. If found effective, this could prove to be a Vital contribution in public health care for this Global Crisis of COVID-19.Timepoint: 1 week→ | | | | Yes | False | | |
| → | CTRI/2020/06/025560 | 27 January 2021 | Difficulty in doing usual work after wearing personal protective equipment. | Issues of carying out usual work in COVID ICU after doning Level 3 Personal Protective Equipment- From Userâ??s Perceptive : A cross-sectional study from tertiary care hospital | | NA | 02-06-2020 | 20200602 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43710 | Not Recruiting | No | | | | 04-06-2020 | 50 | Observational | Single Arm Trial<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Puneet Khanna→ | | Department of Anesthesia,
Fifth floor teaching block,
AIIMS, New Delhi. → | k.punit@yahoo.com→ | 9873106516→ | AIIMS→ | Inclusion criteria: 1) Healthcare workers posted in COVID task force. <br/ ><br>2) Age group 20 to 60 years <br/ ><br>3) Who can understand English language. <br/ ><br>→ | Exclusion criteria: 1) Healthcare workers who have not worked in COVID ICU and not used PPE. <br/ ><br>2) Not willing to participate. <br/ ><br>→ | | | Difficulties faced by health care workers.Timepoint: 1 month→ | | | | Yes | False | | |
| → | CTRI/2020/06/025529 | 27 January 2021 | Knowledge, Practice and mental health status of Spinal injured people | Knowledge, Attitudes, Practice (KAP) of Spinal Cord Injured People towards COVID-19 and their Psychological state during in-patient Rehabilitation in Bangladesh | | Kazi Md Amran Hossain | 02-06-2020 | 20200602 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44243 | | No | | | | 10-06-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Bangladesh→ | Md. Abu Khayer Hasnat→ | | Spinal Cord Injury Unit, Department of Physiotherapy, Centre for the Rehabilitation of the Paralysed, Savar, Dhaka → | akhasnat@hotmail.com→ | 8801710993393→ | Centre for the Rehabilitation of the Paralysed→ | Inclusion criteria: Spinal Cord Lesion patients attending In-patient rehabilitation services at CRP in a specific time frame→ | Exclusion criteria: SCI patient with a serious psychological problem (diagnosed by a psychiatrist) and unable or unwilling to respond or communicate→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: S349- Injury of unspecified nerves at abdomen, lower back and pelvis level
→ | Intervention1: Not applicable: Not applicable<br>Control Intervention1: Not applicable: Not applicable<br>→ | Knowledge attitude and Practice towards COVID 19Timepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/06/025575 | 27 January 2021 | Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised control trial | Safety and efficacy of antiviral combination therapy in symptomatic patients of Covid-19 infection - a randomised control trial - SEV-Covid Trial | | AIIMS Rishikesh | 03-06-2020 | 20200603 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43076 | Recruiting | No | | | | 15-06-2020 | 175 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Alternation Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Prasan Kumar Panda→ | | Department of General Medicine, Sixth Floor, College Block , AIIMS Rishikesh
Dehradun
UTTARAKHAND
249203
India → | prasan.med@aiimsrishikesh.edu.in→ | 9868999488→ | AIIMS Rishikesh→ | Inclusion criteria: 1. Age â?¥18 years at time of participation in the study <br/ ><br>2. Laboratory (RT-PCR) confirmed infection with 2019-nCoV <br/ ><br>3. Willingness of study participant to accept randomization to any assigned treatment arm <br/ ><br>4. Must agree not to enrol in another study of an investigational agent prior to completion of the present study <br/ ><br>→ | Exclusion criteria: 1. Use of medications that are contraindicated with lopinavir/ritonavir, Hydroxychloroquine/ Chloroquine and that cannot be replaced or stopped <br/ ><br>4. Physicianâ??s decision that participation in the trial is not in patientsâ?? best interest, or any condition that does not allow the protocol to be followed safely <br/ ><br>5. Patient already on antiretroviral therapy with Lopinavir-Ritonavir based regimen or on Hydroxychloroquine/Chloroquine <br/ ><br>6. Any known contraindication to test drugs such as retinopathy and QT prolongation <br/ ><br>7. Known allergic reaction to Lopinavir-ritonavir, Hydroxychloroquine/ Chloroquine <br/ ><br>8. Pregnant or breastfeeding females <br/ ><br>9. Receipt of any experimental treatment for 2019-nCoV (off-label, compassionate use, or trial related) within 30 days prior to participation in the present study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Standard Treatment (STns): 1. Strict Isolation<br>2. Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask)<br>3. Hydration<br>4. Proper Nutrition<br>5. Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant)<br>6. Treatment of Comorbid Diseases<br>7. Oseltamivir (75 mg BD) for patient who are tested positive for H1N1<br>If the patient improves clinically the same treatment will be continued. If the patient do-not improve or shows sign of severity (mentioned above) the patient will be shifted to the severity arm (S-group) of the clinical trial with randomization again.<br>Intervention2: Standard Treatment for severe patients: (STs): 1. Strict Isolation<br>2. Standard Precautions (Hand hygiene, Cough Etiquette, Wear surgical mask)<br>3. Fluid Therapy <br>4. Supportive Pharmacotherapy (Antipyretic, Antiallergic, Cough Suppressant)<br>5. Oxygen supplementation (As required)<br>6. Invasive ventilation (As required)<br>7. Antibiotic agents for other associated infections (according to 2019 ATS/IDSA guidelines for non-ICU and ICU patients)<br>8. Vasopressor support<br>9. Renal-replacement therapy<br>10. Treatment of Comorbid Diseases<br>11. Oseltamivir (75 mg BD) for patient who are tested positive for H1N1<br>Patients will be assessed for clinical improvement in every 48-72 hours of treatment. In case the patient do not respond to the current treatment regimen the patient will be shifted to alternative regimen in the same treatment group. If the patient progress in the same group then patient will be shifted to biologics (Tocilizumab). In case the patient do not respond in the next 48-72 hours and continue to deteriorate on the current treatment then the all experimental treatment will be stopped and Standard Treatment (STs) will be continued. <br><br>Intervention3: Standard Treatment (→ | 1. Time to Clinical recovery (TTCR) <br/ ><br>TTCR is defined as the time (in hours) from initiation of study treatment (active or placebo) until normalisation of fever, respiratory rate, and oxygen saturation, and alleviation of cough, sustained for at least 72 hours. <br/ ><br> <br/ ><br>2. Time to 2019-nCoV RT-PCR negative in upper respiratory tract specimenTimepoint: 72hrly→ | | | | Yes | False | | |
| → | CTRI/2020/06/025588 | 27 January 2021 | Data of patients with Corona virus disease admitted to the ICU at P.D. Hinduja Hospital, Mumbai. | Clinical profile and outcomes of patients with Corona virus disease 19 (COVID â?? 19) admitted to a tertiary care hospital in Mumbai. - COVID-HINDUJAICU | | PDHinduja Hospital and MRC | 03-06-2020 | 20200603 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43851 | Not Recruiting | No | | | | 08-06-2020 | 400 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Alex Fonseca→ | | Department of Critical Care, P.D. Hinduja Hospital and MRC,
Veer Savarkar Marg,
Mahim, Mumbai. → | fnkapadia@gmail.com→ | 9821031643→ | P.D. Hinduja National Hospital and MRC→ | Inclusion criteria: All COVID positive patients admitted to the COVID ICU.→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Clinical outcome.Timepoint: At time of discharge from ICU→ | | | | Yes | False | | |
| → | CTRI/2020/06/025590 | 27 January 2021 | A clinical trial to evaluate safety and efficacy of polyherbal capsule Astha-15 used as an add on therapy with standard care of therapy as an immunity booster in the suspected and COVID-19 diagnosed patients. | A Multi-centric, Double blind, Randomized, Comparative, Parallel-group, Placebo-controlled,
Phase III clinical trial to evaluate the efficacy and safety of polyherbal capsule
Astha-15 used as an add on therapy with standard care of therapy as an immunity booster, anti-cough, expectorant, anti inflammatory, cardio-protective, hepato-protective, broncho-protective in the suspected and COVID-19 diagnosed patients. | | Dalmia Centre for Research and Development | 03-06-2020 | 20200603 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44121 | Not Recruiting | No | | | | 08-06-2020 | 120 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 3 | India→ | Mukesh Kumar→ | | A-19, 1st floor, Street No.-3, Gurunanak Pura, Laxmi Nagar → | mukesh@rahelife.com→ | 9873038019→ | RAHE Life Science→ | Inclusion criteria: 1. Subject who agrees for giving informed consent and provide signed and dated written IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures. <br/ ><br>2. Non-ICU patients suspected and diagnosed of COVID-19 diseases (In hospital isolation / quarantine ward). <br/ ><br>3. Subjects having stable common respiratory associated disorders like Flu & common cold, allergic rhinitis, asthma and COPD.→ | Exclusion criteria: 1. Subjects who are not able to or not willing to sign an IRB/IEC approved consent <br/ ><br>form. <br/ ><br>2. Subject with positive pregnancy test as confirmed by urine dipstick test and who is planning to become pregnant within the study duration/lactating mothers. <br/ ><br>3. Patients having psychiatric, musculoskeletal or cardiovascular diseases. <br/ ><br>4. Patients suffering from concurrent systemic diseases, with cardiopulmonary tuberculosis, pulmonary eosinophilia, bronchiectasis, cancer, congestive heart failure, hepatic dysfunction, neurological disorders and diarrhoeal disorders. <br/ ><br>5. Patients having a haemoglobin level <10 g/dl. <br/ ><br>6. Patients having serious or unstable respiratory and its associated disorders. <br/ ><br>7. Use of systemic corticosteroid therapy (this may affect peripheral muscle function). <br/ ><br>8. Thyrotoxicosis, or diabetes treated with insulin. <br/ ><br>9. Subjects having BMI less than 18.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J00-J99- Diseases of the respiratory system
→ | Intervention1: Astha-15 capsule: Two capsules to be taken orally twice a day.<br>Two capsules after breakfast and two capsules after dinner with standard care of therapy<br>Control Intervention1: Placebo: Two capsules to be taken orally twice a day. Two capsules after breakfast and two capsules after dinner with standard care of therapy<br>→ | 1. Changes in scores of the St. George Respiratory Questionnaire from baseline to EOT visit. <br/ ><br>2. Changes in scores of the Leicester Cough Questionnaire from baseline to EOT visit.Timepoint: Day -2 to -1, Day 1, Day 14, Day 28 (End of Treatment), Day 35 (Follow-up)→ | | 28/09/2020 | | Yes | False | | |
| → | CTRI/2020/06/025589 | 27 January 2021 | comparison of two different laryngoscopes using COVID barrier box | COVID barrier box: Comparison between Macintosh laryngoscope with king vision video laryngoscope in patients posted for surgery, A randomized control trial. | | AIIMS Bhubaneswar | 03-06-2020 | 20200603 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44164 | Not Recruiting | No | | | | 15-06-2020 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India→ | Sangeeta Sahoo→ | | Room NO-5
Fifth Floor
Hospital block
AIIMS Bhubaneswar Room NO-356
Third floor
Academic block
AIIMS Bhubaneswar→ | drsangeeta.asth@gmail.com→ | 2472312→ | AIIMS BHUBANESWAR→ | Inclusion criteria: Patients of either sex aged 18 â?? 65 years; ASA grade I-II undergoing both elective and emergency surgeries under general anesthesia will be included.→ | Exclusion criteria: ASA III and IV patients, mentally challenged patients, Patients with neurological deficit, Anticipated difficult airway, obese patients→ | Health Condition 1: B97- Viral agents as the cause of diseases classified elsewhere
→ | Intervention1: COVID barrier box: COVID barrier box which will cover patients head and neck during intubation.. It is crucial to estimate the intubation time and first-pass success rate of intubation using COVID barrier box in patients requiring elective and routine surgeries. The trial will be done to determine the impact of an Covid barrier box on endotracheal intubation, which will be done by Macintosh laryngoscope or Ambu King video laryngoscope.<br>Control Intervention1: NIL: NIL<br>→ | intubation timeTimepoint: baseline, 5 mins ,15 mins→ | | | | Yes | False | | |
| → | CTRI/2020/06/025561 | 27 January 2021 | Effect of Ayurvedic medicine in the Prophylaxis for COVID-19 of AYUSH healthcare workers , Dept of AYUSH, TS & CCRAS- NIIMH, Hyderabad.
| Prospective open label observational study on the effect of AYUSH-64, Samshamani vati & Chyavanprash- (Ayurvedic Raksha Kit-l) as Prophylactic measure among AYUSH healthcare workers working in the vicinity of COVID -19 facilities. | | Department of AYUSH Govt of Telangana Ayurveda CCRASNIIMH Hyderabad | 03-06-2020 | 20200603 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44244 | Recruiting | No | | | | 15-06-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Dr Srikanth Babu Perugu→ | | Department of Kayachikitsa, Dr. B.R.K.R. Government Ayurvedic
College SR Nagar Hyderabad
Hyderabad
TELANGANA #101, district judges quarters,
road no 10,banjara hills, Hyderabad- 500034→ | drperugu@gmail.com→ | 9849463878→ | | Inclusion criteria: 1. AYUSH health care workers working within the facilities of COVID-19 duties. <br/ ><br>2. Subjects who are from a community where at least 1 confirmed case is already identified. <br/ ><br>3. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br>→ | Exclusion criteria: Exclusion criteria: <br/ ><br>1. Pregnant and Lactating females. <br/ ><br>2. Known cases of uncontrolled Diabetes and Hypertension. <br/ ><br>3. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>5. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>7. Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. <br/ ><br>8. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol <br/ ><br> <br/ ><br> <br/ ><br>→ | | Intervention1: RAKSHA KIT-1: Chavanprash, 10 grams once aday Samshamani vati 250 mg 2 times a day<br>& AYUSH 64 500 mg 2 times a day<br>Control Intervention1: Standard Prophylactic Care: Standard Prophylactic Care recommended by Government of Telangana Health authorities<br>→ | Comparative assessment of occurrence of <br/ ><br>COVID-19 infection in healthy volunteers vis <br/ ><br>Police personal in community having at least 1 <br/ ><br>confirmed case already identified with control <br/ ><br>arm of Standard Prophylactic CareTimepoint: 0 day and <br/ ><br>40th day <br/ ><br>Comparative assessment of occurrence of <br/ ><br>COVID-19 infection in healthy <br/ ><br> volunteers vis <br/ ><br>AYUSH personal in community having at least 1 <br/ ><br>confirmed case already identified with control <br/ ><br>arm of Standard Prophylactic Care→ | | | | Yes | False | | |
| → | CTRI/2020/06/025613 | 27 January 2021 | Melatonin Immune Boost COVID 19 Study | Melatonin For COVID 19 pre exposure prophylaxis in High Risk population . (MELATONIN IMMUNE BOOST COVID 19 STUDY ) | | Rohit Walia | 04-06-2020 | 20200604 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44346 | Not Recruiting | No | | | | 15-06-2020 | 200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 4 | India→ | Rohit Walia→ | | Room number 25103 , Department of Cardiology , All India Institute of medical Science ,Rishikesh , Uttrakhand , India → | rwalia7731@yahoo.in→ | 8800492549→ | All India Institute of Medical Science Rishikesh→ | Inclusion criteria: High groups for COVID 19 related disease <br/ ><br>Elderly : age > 60 years <br/ ><br>Diabetes <br/ ><br>Obesity <br/ ><br>Heart Failure <br/ ><br>Immuno supressed patients <br/ ><br>→ | Exclusion criteria: Chronic Renal Failure <br/ ><br>Chronic Hepatic Failure <br/ ><br>Any hospitalisation for past 3 months <br/ ><br>Any recent vaccination <br/ ><br>Nutrition supplements <br/ ><br>Any addiction <br/ ><br>Chronic infections live Human immunodeficiency disorder , Hepatitis B,C., etc <br/ ><br>Any autoimmune disease <br/ ><br>Irregular sleep pattern <br/ ><br>Primary immunodeficiency states <br/ ><br>Vitamin deficiency states→ | | Intervention1: Melatonin: Oral melatonin 3 mg at 6 pm daily once x 8 weeks<br>Control Intervention1: Placebo: Placebo for 8 weeks<br>→ | SARS-CoV 2 infection rate : Number of confirmed (positive CRP) symptomatic infections in each treatment group <br/ ><br>Timepoint: 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/06/025593 | 27 January 2021 | A study to determine relative efficacy of hydroxy-chloroquine prophylaxis to healthcare-professionals for Covid-19 mitigation | â??Relative efficacy of hydroxy-chloroquine prophylaxis to healthcare-professionals for Covid-19 mitigation: a pragmatic prospective observational study (RE-HCP2 COVID study)â?? - RE-HCP2 COVID study | | AIIMS Rishikesh | 04-06-2020 | 20200604 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44173 | Not Recruiting | No | | | | 12-06-2020 | 3000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Prasan Kumar Panda→ | | Department of General Medicine, Sixth floor, College block, AIIMS Rishikesh → | prasan.med@aiimsrishiekesh.edu.in→ | 9868999488→ | AIIMS Rishikesh→ | Inclusion criteria: 1.Any Asymptomatic Medical professional (MP) of either sex (including pregnant and lactating female), >18 years of age and > 45 kg of weight, based in a primary, secondary or tertiary healthcare setting, who is already taking or willing to take chloroquine prophylaxis in anticipation of high risk of developing COVID-19 due to his/her potential exposure to patients with SARS-CoV-2 infection or having risk of this infection. <br/ ><br>2.Special inclusion of MPs for case control arm will be: <br/ ><br>a.Those who are reluctant to take any prophylaxis <br/ ><br>b.MP with history of the following conditions: Retinopathy or retinal disease; Cardiomyopathy; Cardiac arrhythmia; Prolonged QTc; Psoriasis; Porphyria cutanea tarda; Epilepsy; Myasthenia gravis; Myopathy of any cause; Serious hepatic or renal disease; Glucose-6-phosphate dehydrogenase deficiency (G6PD); Severe depression which prevent chloroquine use <br/ ><br>c.Self-reported current use of medication with known serious hepatotoxic effects or known interaction with chloroquine/ hydroxychloroquine as listed in appendix 3 which prevent chloroquine use. <br/ ><br>→ | Exclusion criteria: 1.Weight outside range 45 kg â?? 150 kg (99 lbs â?? 330 lbs). <br/ ><br>2.Prior enrolment into this observational study. <br/ ><br>3.Self-reported or diagnosed infection with SARS-CoV-2 or previous COVID-19 diagnosis within the last 6 months. <br/ ><br>4.Self-reported current acute respiratory infection <br/ ><br>5.Inability or unwillingness to be followed up for the trial period <br/ ><br>→ | | | (1) Incidence of Symptomatic COVID-19 in each one of 4 arms; <br/ ><br>Clinical diagnosis of COVID-19 with virology confirmation, with limitation of activities (WHO Severity Scale 2-8) over the study enrolment period. <br/ ><br>(2) Incidence of Peak severity of COVID-19 over the study period in COVID-19 positive MPs <br/ ><br>Timepoint: at multiple intervals over 3months→ | | | | Yes | False | | |
| → | CTRI/2020/06/025637 | 27 January 2021 | As the present outbreak of novel coronavirus in Indian scenario we want to study about the prophylactic study in Distric Hospital, Vidisha. | Indian Ancient system for the prophylaxis of COVID-19 - No | | ABVMC RC VIDISHA | 05-06-2020 | 20200605 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43550 | Not Recruiting | No | | | | 22-06-2020 | 10 | Interventional | Cluster Randomized Trial<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Sarvesh Sharma→ | | SMS, DH, Vidisha
Department of Pharmacy
Room No138
NH-86, Bhopal Road , Near Vivekanand Square Vidisha SMS, DH, Vidisha
Department of Pharmacy
Room No138
NH-86, Bhopal Road , Near Vivekanand Square Vidisha→ | sarbiotechdh@gmail.com→ | 9893194659→ | DH, Vidisha→ | Inclusion criteria: All are healthy human involve for study purpose→ | Exclusion criteria: Abnormal symptoms if comes they excluded from the study→ | | Intervention1: Piper betal with the combination of swarnabhasma (Herbo mineral combination): ! leaf of piper betal and 01 mg of swarna bhasma in herbal presentation thrice in a day<br>→ | Parameter will test :Complete blood picture,Serum ferritin,C-reactive protein,LDH,Troponin, Nucleic acid amplification test and RT-PCRTimepoint: every 3 day with baseline up to 8 week→ | | | | Yes | False | | |
| → | CTRI/2020/06/025625 | 27 January 2021 | Study of the effect of Siddha Treatment in addition to standard therapy in COVID-19 patients | A Prospective, Multicenter, Randomized, Open-Label, Proof-of-Concept (PoC) Study to Evaluate the Efficacy and Safety of Siddha Treatment in Patients with Novel Coronavirus Infectious Disease (COVID-19) - START (Siddha Treatment Accelerating Recovery from SARS-CoV-2 Test) | | Eminentlabs Business Solutions Pvt Ltd | 05-06-2020 | 20200605 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43345 | Recruiting | No | | | | 11-05-2020 | 86 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Dr JEYA VENKATESH→ | | Kokila Siddha Hospital and Research Centre
Madurai 27Jaihindpuram I Street
Madurai
→ | jeyavenkateshdrs@gmail.com→ | | Kokila Siddha Hospital and Research Centre→ | Inclusion criteria: 1. Males and females aged 18 to 75 years, both inclusive <br/ ><br>2. Have laboratory confirmed COVID-19 disease <br/ ><br>3. Asymptomatic patients (who are positive for SARS CoV-2 and with no symptoms) or meets clinical features of the following grades of severity (Appendix II): <br/ ><br>a. Group 1: Suspect and confirmed cases clinically assigned as mild and very mild <br/ ><br>Clinical criteria: Cases presenting with fever and/or upper respiratory tract illness (Influenza Like Illness, ILI). <br/ ><br>b. Group 2: Suspect and confirmed cases clinically assigned as moderate <br/ ><br>Clinical criteria: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30 breaths/minute, SpO2 90%-94%). <br/ ><br>4. Agrees to practice contraception during the entire study treatment period and for 3 months after the last treatment of IMP is administered: <br/ ><br>a. Using double barrier contraception, <br/ ><br>b. or, is truly sexually abstinent, when this is in line with the preferred and usual lifestyle of the participant <br/ ><br>Note: Periodic abstinence [e.g. calendar, ovulation, symptothermal, postovulation methods for the female partner with childbearing potential] and withdrawal are not acceptable methods of contraception. <br/ ><br>5. Patients or their legal representatives have personally signed and dated the informed consent form (ICF) before completing any study-related procedure, which means before any assessment or evaluation that would not have formed a part of his/her normal medical care <br/ ><br>6. Patients willing to adhere and comply with the protocol related procedures <br/ ><br>7. Patients willing to take Siddha drug regimen for COVID-19 <br/ ><br>8. Agrees not to participate in other clinical studies within 30 days after the last administration of the study drug→ | Exclusion criteria: 1. Patients with other viral pneumonia <br/ ><br>2. Patients with severe or critical COVID-19 disease <br/ ><br>3. Patients who have taken antibiotics/antivirals in the past 1 week <br/ ><br>4. Patients with history of asthma, chronic obstructive pulmonary disease or any other chronic lung disease <br/ ><br>5. Patients with any active malignancy <br/ ><br>6. Patients who have received organ transplantation in the past 6 months or planning surgery <br/ ><br>7. Patients who cannot take food or drugs orally <br/ ><br>8. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ ><br>9. Patients who have severe underlying diseases that affects survival, including blood diseases, dyscrasia, active bleeding, severe malnutrition, etc <br/ ><br>10. Patients with uncontrolled blood pressure (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg) or uncontrolled diabetes (HbA1C >7%) <br/ ><br>11. Women patients who are pregnant or lactating, or patients (including male patients) having a pregnancy plan (including plans for sperm donation or egg donation) <br/ ><br>12. Patients with allergic constitution, or patients allergic to investigational products <br/ ><br>13. Patients positive for human immunodeficiency virus, Hepatitis B and Hepatitis C at screening <br/ ><br>14. Patients whose alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal <br/ ><br>15. Patients requiring Extracorporeal Life Support Program (ECLS), i.e. Extracorporeal Membrane Oxygenation (ECMO), Extracorporeal carbon dioxide removal (ECCO2R) or Registered Respiratory Therapist (RRT) <br/ ><br>16. Critical patients with life expectancy <48 hours <br/ ><br>17. Patients who are not suitable to participate in the study based on the investigatorâ??s judgement <br/ ><br>18. Patients who have participated in any clinical trial 30 days prior to screening <br/ ><br>19. Clinically significant laboratory findings at screening→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 1. Kabasura kudineer <br>2. Bramanandha bairavam: 1. Kabasura kudineer 60 ml twice daily (90 minutes before food - Morning 7.00 and evening 6.00) for 14 days<br>2. Bramanandha bairavam 100 mg thrice daily (30 minutes after food) with honey or ginger juice for 14 days <br><br>Control Intervention1: Standard Covid Treatment Protocol: As Standard of care recommended by ICMR<br>A. Mild symptoms:<br>1. Tablet Oseltamivir 2. Antibiotics if needed (azithromycin + amoxicillin /clavulanic acid)<br>3. Paracetamol<br>B. Moderate symptoms<br>1. Oxygen supplementation<br>2. Antipyretics, antitussives, antibiotics as indicated<br>3. Metered Dose Inhaler preferred over nebulization<br>4. Hydroxychloroquine<br>5. Lopinavir/ Ritonavir (within 10 days of symptom onset) may be considered on case to cases<br>→ | Proportion of patients confirmed as negative for SARS-CoV-2 in 2 consecutive throat/nasal swabs (taken 24 hours apart) at Day 15/Day16.Timepoint: To compare the efficacy of Siddha drug regimen plus Standard of Care (SoC) with SoC alone in the treatment of Covid-19 positive patients.→ | | | | Yes | False | | |
| → | CTRI/2020/06/025664 | 27 January 2021 | Phase II study to evaluate the Safety and Efficacy of 2-Deoxy-D-Glucose in COVID -19 patients | A Randomized, Open Label, 2-Treatment Groups Clinical Trial Evaluating the Safety and Efficacy of 2-Deoxy-D-Glucose as an adjunctive therapy to standard of care, in comparison to standard of care alone, in the Acute Treatment of moderate to severe COVID -19 patients | | Dr Reddys Laboratories Limited | 05-06-2020 | 20200605 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44369 | Recruiting | No | | | | 15-06-2020 | 40 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Open Label | Phase 2 | India→ | D Mallikarjuna Rao→ | | Proprietary Products
Regulatory Affairs
Innovation Plaza, IPDO
Survey No. 54
Bachupally village
Bachupally Mandal → | mallikarjunard@drreddys.com→ | 914044346860→ | Dr. Reddys Laboratories Limited→ | Inclusion criteria: 1. Male, female and transgender patients aged â?¥ 18 years and â?¤ 65 years <br/ ><br>2. Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab <br/ ><br>Note: A re-treated/ relapsed patient may be enrolled if he/she meets all of the following criteria: <br/ ><br>a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARS-CoV-2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARS-CoV-2 after previous treatment <br/ ><br>AND <br/ ><br>b. Clinical symptoms associated with COVID-19 (fever, cough, difficulty in breathing, fatigue, body ache, headache, diarrhea, nasal congestion) have either re-appeared after previous treatment OR continued to be present without improvement OR are aggravated <br/ ><br>AND <br/ ><br>c. Patient meet the below-mentioned criterion (# 3) for â??moderateâ?? or â??severeâ?? COVID-19 disease severity <br/ ><br>3. Patients clinically assigned as â??moderateâ?? (Pneumonia with no signs of severe disease, respiratory rate 15 to 30/minute, SpO2 90%-94%) or â??severeâ?? (Severe Pneumonia with respiratory rate â?¥30/minute and/or SpO2 < 90% in room air) but not critically ill (acute respiratory distress syndrome [ARDS], multi organ failure or septic shock) <br/ ><br>Note: The severity is as defined by the Guidance document on appropriate management of suspect/confirmed cases of COVID-19 published by the Ministry of Health & Family Welfare on 07 Apr 2020. <br/ ><br>4. Females should have a negative serum pregnancy test at baseline; female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment <br/ ><br>5. Able and willing to provide informed consent <br/ ><br>6. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ ><br>7. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment→ | Exclusion criteria: 1. Critically ill patients, defined as those who are candidates for endotracheal intubation and invasive mechanical ventilation and those with ARDS, septic shock or multi-organ failure at baseline <br/ ><br>2. Patients with previous history of hypersensitivity or a contra-indication to the IMP 2-deoxy-D-glucose or the imaging marker Fludeoxyglucose (FDG) <br/ ><br>3. Patients with history of one or more known comorbidities at baseline: <br/ ><br>a. Cardiac Failure <br/ ><br>b. Prior or concurrent ischemic coronary artery disease (CAD): angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetalâ??s angina <br/ ><br>c. Cardiac conduction delay (QTc > 500 msec) or taking any prescription medications known to prolong QT interval <br/ ><br>d. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders <br/ ><br>e. Diabetes Mellitus or any condition predisposing to hypoglycaemia <br/ ><br>f. Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) <br/ ><br>g. Asthma or Interstitial Lung Disease <br/ ><br>h. Malignancy <br/ ><br>i. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ ><br>j. Presence of any contra-indication to the chosen Standard of Care treatment <br/ ><br>4. Patients who are receiving drugs known to prolong the QT interval of heart including hydroxychloroquine or azithromycin OR are expected to require treatment with the same during the treatment period in the study (as of baseline assessment). <br/ ><br>5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit). <br/ ><br>6. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients. This includes patients receiving other investigational therapies for COVID-19. <br/ ><br>7. Inability to take oral medication. <br/ ><br>8. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ ><br>9. Body Weight < 45 kg or >130 kg <br/ ><br>10. Female patients who are pregnant or lactating <br/ ><br>11. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg. Methotrexate, Cyclosporine, etc.) <br/ ><br>12. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment <br/ ><br>13. Patients who are not suitable to participate in the study based on the Investigatorâ??s judgeme→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 2-Deoxy-D-Glucose Oral Powder: 45 mg/kg Morning + 18 mg/kg Evening as long as SoC is being administered, but no longer than discharge or Day 28 (whichever is earlier)<br>Control Intervention1: Standard of Care: Upto Day 28 discharge but no more than Day 28<br>→ | Time to â??Clinical improvementTimepoint: Day 3,7,10,14 and 28 (until patient reaches score of 4 or lower on 10 point ordinal scale for clinical status or discharge, whichever is earlier).→ | | | | Yes | False | | |
| → | CTRI/2020/06/025634 | 27 January 2021 | To assess the postoperative outcomes after implementation of the protocol in patients undergoing surgery for gynaecological malignancies in the COVID-19 pandemic | Covid ERAS-Effect of implementation of the Enhanced Recovery After Surgery (ERAS) protocol on patients undergoing surgery for gynaecological malignancy during
the COVID-19 | | Dr Kanika Batra Modi | 05-06-2020 | 20200605 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43893 | Not Recruiting | No | | | | 15-06-2020 | 40 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Kanika Batra Modi→ | | East block, service floor, Oncology department
Max Super Speciality Hospital,(A Unit of Devki Devi Foundation),2,Press Enclave Road,Saket,New Delhi → | kanica.batra@gmail.com→ | 9873150686→ | Max Super Speciality Hospital(A Unit of Devki Devi Foundation),Saket→ | Inclusion criteria: Patients diagnosed with an ovarian/fallopian tube/peritoneal cancer of any histology <br/ ><br>(collectively referred to as ovarian cancer), endometrial cancer surgery, cervical <br/ ><br>vulvar or vaginal cancer surgery in all stage, as indicated as indicated for surgery <br/ ><br>were included in the trial. The pre-assessment triage including respiratory symptoms, <br/ ><br>temperature, history of exposure or travel. Patients selected after this would be <br/ ><br>â??screenedâ?? with the RT-PCR test 48â?¯hours before the surgery and then isolated in <br/ ><br>their rooms with no visitors allowed.→ | Exclusion criteria: Exclusion criteria were: <br/ ><br> minimally invasive surgery; <br/ ><br>emergency surgery due to any associated cause→ | Health Condition 1: N998- Other intraoperative and postprocedural complications and disorders of genitourinary system
→ | | The primary endpoint will be assessment of Length of Hospital Stay (LOS) with the <br/ ><br>implementation of an enhanced recovery after surgery pathway. LOS was defined as <br/ ><br>the number of days from the day of surgery to discharge.Timepoint: 8 Months→ | | | | Yes | False | | |
| → | CTRI/2020/06/025650 | 27 January 2021 | To assess the safety and outcome of herbal medicine in prevention of COVID-19 infection among high risk population | A Prospective Cohort Interventional Study Assessing the Safety and Outcome of Unani Medicine as a Prophylaxis in Population at risk of COVID-19 | | Ministry of AYUSH Government of India | 05-06-2020 | 20200605 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44412 | Not Recruiting | No | | | | 15-06-2020 | 4000 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Prof Abdul Wadud→ | | Dept. of Ilmul Advia
National Institute of Unani Medicine
Kottigepalya Magadi Main Road
Bangalore → | drwadud87@gmail.com→ | 9916608881→ | National Institute of Unani Medicine→ | Inclusion criteria: 1. Population as described in High/Moderate/Low Risk <br/ ><br>2. Individuals who are from the identified containment zone/ quarantine facility with at least 1 confirmed COVID-19 positive case. <br/ ><br>3. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br>→ | Exclusion criteria: 1. Persons with severe primary respiratory disease or related complications that may be identified with COVID-19 <br/ ><br>2. Laboratory confirmed COVID-19 with or without symptoms <br/ ><br>3. Pregnant and lactating mothers and those who have a pregnancy plan. <br/ ><br>4. Persons with serious critical illness, or severe mental illnesses <br/ ><br>5. Individuals with uncontrolled, unstable co-morbidities <br/ ><br>6. Immuno-compromised individuals or those on immune-suppressants and steroids <br/ ><br>7. Subjects having a past history of allergy to any medicine that is part of the Unani intervention→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Joshanda (Decoction) and Khameera Marwareed: Joshanda (Decoction) of the following<br><br>1. Behidana (Cydonia oblonga) 3 gm<br>2. Unnab (Zizyphus jujube)<br>5 in number <br>3. Sapistan (Cordia myxa)<br>9 in numbers<br><br>Dose: 125 ml OD morning<br>Route of Administration: Orally<br><br>and<br><br>Khameera Marwareed<br><br>Dose: 5g OD morning<br>Route of Administration: Orally<br>Control Intervention1: NIL: Subjects not receiving Unani prophylactic regimen<br>→ | 1. Incidence of COVID-19 cases in control as well in interventional group <br/ ><br>2. Improvement in immune status using Immune Status Questionnaire (ISQ)Timepoint: 0th Day, 10th Day, 20th Day and 35th Day→ | | | | Yes | False | | |
| → | CTRI/2020/06/025673 | 27 January 2021 | A study on association between tobacco and COVID 19 to help policy makers | Generating evidence to support policy and practice to address tobacco use during and beyond the COVID-19 pandemic in India | | nil | 06-06-2020 | 20200606 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44398 | Not Recruiting | No | | | | 30-07-2020 | 80 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Muralidhar Kulkarni→ | | Department of Community Medicine,Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal
Udupi → | murali.kulkarni@manipal.edu→ | 9844810917→ | Kasturba Medical College, Manipal→ | Inclusion criteria: stake holders involved in tobacco control→ | Exclusion criteria: nil→ | | Intervention1: not applicable: not applicable<br>→ | Summary of stakeholder survey findings <br/ ><br>Report outlining findings from the rapid evidence review <br/ ><br>Policy and practice briefings for stakeholders <br/ ><br>Webinars for stakeholders involved in tobacco control and COVID 19 management <br/ ><br>Timepoint: Summary of stakeholder survey findings -4 weeks <br/ ><br>Report outlining findings from the rapid evidence review-6 months <br/ ><br>Policy and practice briefings for stakeholders-6 months <br/ ><br>Webinars for stakeholders involved in tobacco control and COVID 19 management-6months <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/06/025672 | 27 January 2021 | To evaluate the effect of herbal medicine in prevention and management of COVID-19 | To evaluate the impact of Unani polyherbal formulation in the prophylaxis and clinical management of COVID-19 | | Ministry of AYUSH Government of India | 06-06-2020 | 20200606 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44415 | Not Recruiting | No | | | | 15-06-2020 | 60 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Fasihur Rehman Ansari→ | | Dept. of Moalajat
National Institute of Unani Medicine
Kottigepalya Magadi Main Road → | dr.mariyamahad@gmail.com→ | 9412456250→ | National Institute of Unani Medicine→ | Inclusion criteria: 1. Definite diagnosis of COVID-19; fulfilling WHO case definition, including a positive PCR from any specimen (e.g. respiratory, blood, urine, stool, other bodily fluid) and presence of one or more of the following associated symptoms- <br/ ><br>cough <br/ ><br>fever ( > 37.5° C / 99.5° F) <br/ ><br>shortness of breath <br/ ><br>sore throat <br/ ><br>2. Hospitalized patients with no oxygen therapy or oxygen by mask or nasal prongs. <br/ ><br>3. Understand and agreed to comply with the study→ | Exclusion criteria: 1. Patient below 18 year of age. <br/ ><br>2. K/c/o Cardiovascular diseases like Ischaemic heart disease, Coronary Artery disease. <br/ ><br>3. K/c/o Chronic Kidney disease, Chronic Lung disease, Chronic neurological disorder, Pulmonary Tuberculosis. <br/ ><br>4. Pregnant and Lactating women. <br/ ><br>5. Patient on non-invasive ventilation or high flow oxygen. <br/ ><br>6. Patient on intubation and mechanical ventilation. <br/ ><br>7. Patient on ventilation + additional organ support-pressor, RRT, ECMO.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Joshanda (Decoction): Joshanda (Decoction) of the following:<br><br>1. Anjeer (Ficus carica L.) 3 Nos.<br>2. Unnab (Ziziphus jujuba Mill.) 5 Nos.<br>3. Sapistan (Cordia dichotoma Forst. f) 7 Nos.<br>4. Zanjabeel (Zingiber officinale Rosc.) 6 gm<br>5. Behidana (Cydonia oblonga Mill.) 6 gm<br>6. Aslusoos (Glycyrrhiza glabra L.) 6 gm<br><br>Dose: 50 ml BD (Morning and Evening)<br>Route of Administration: Orally<br>Duration of therapy: 14 days<br>Control Intervention1: NIL: NIL<br>→ | The outcome will be focused on decrease severity of parameters: <br/ ><br>â?? Fever <br/ ><br>â?? Sore Throat, Cough with sputum, Cough with haemoptysis, Dyspnoea (Shortness of breath), Wheezing, Chest pain, Runny nose, Fatigue, Headache, Arthralgia, Irritability/confusion, Seizures, Nausea/Vomiting, Diarrhoea, Abdominal pain, skin rashesTimepoint: 0th Day, 14th Day and 21st Day→ | | | | Yes | False | | |
| → | CTRI/2020/06/025671 | 27 January 2021 | A clinical trial to evaluate the medicinal efficacy of Ayurvedic Tablet Bhoumya and Tablet Saathmya in COVID-19 positive Patients. | To Evaluate the Efficacy and safety of Tablet Bhoumya and Tablet Saathmya as an add-on Therapy to Standard of Care in COVID-19 Positive Patients. - NIL | | Dr Giridhara Kaje | 06-06-2020 | 20200606 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44425 | Not Recruiting | No | | | | 15-06-2020 | 10 | Interventional | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | Dr Harish M→ | | Prashanthi Ayurvedic Centre,
Department of Panchakarma, Ground Floor, Consultation Room 2, 31/85, Chord Road, 2nd Block, Rajajinagar, Bengaluru
31/85, Chord Road, 2nd Block, Rajajinagar, Bengaluru
560010→ | prashanthiayurvedic@gmail.com→ | 9845557105→ | Prashanthi Ayurvedic Centre→ | Inclusion criteria: Patients ready to give informed consent <br/ ><br>COVID-19 Test - +ve <br/ ><br>Patients who can take oral medicine. <br/ ><br>Patients aged >18 years both male and female <br/ ><br>Uncomplicated illness and Mild Pneumonia Cases→ | Exclusion criteria: Patients not ready to give informed consent <br/ ><br>Pregnant women and lactating mother <br/ ><br>Peadiatric patients 0-18 years <br/ ><br>Severe Pneumonia, Acute Respiratory Distress Syndrome, Sepsis & Septic Shock cases <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tablet Bhoumya <br>Tablet Saathmya: Tablet Bhoumya 600mg<br>Tablet Saathmya 500mg<br>2 tablets each, 3 times a day, after food for 15 days as add-on therapy in addition to standard care of treatment.<br>Control Intervention1: Standard of care in COVID-19 Positive patients: Patients on Standard care medicines, who are not on any of the Ayurvedic Medicines.<br>→ | 1.Time in days for Clinical cure:Stable normal clinical temperature and vitals in 3-5-7-10-14 days. <br/ ><br>2.Time in days till RT-PCR is negative . <br/ ><br>3.Rate of improvement of IL-6 levels at 0-7-14 days as compared to baseline. <br/ ><br>Timepoint: From the baseline till the end of 15 days.→ | | | | Yes | False | | |
| → | CTRI/2020/06/025675 | 27 January 2021 | This study has been conducted to collect the Cough and breathing sound of COVID-19 positive and COVID-19 negative patients for analysis of early indication of COVID-19 in humans. | Collection of Cough & Sound data for building an AI-ML powered software tool for early indication of Covid-19 in humans - iCOVID19 Project | | Imperial Clinical Research Services | 06-06-2020 | 20200606 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44427 | Not Recruiting | No | | | | 15-06-2020 | 600 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India→ | Pragya Yadav→ | | Head Clinical Operations,Clinicnal Research Department
Flat S-4, Plot 31, Naveen Park Sahibabad, Ghazaiabad → | kumar.ajeet10101981@gmail.com→ | 9910104842→ | Imperial Clinical Research Services→ | Inclusion criteria: COVID19-Positive or COVID-19 suspected patients <br/ ><br>Ready for giving the voice sample on Online portal via mobile app. <br/ ><br>can give at least three cough sample and 1 breath voice sample. <br/ ><br> <br/ ><br>→ | Exclusion criteria: Not ready to give the data. <br/ ><br>Not able to use to online portal for data collection.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | The primary objective of this research study is to utilize the data that is being collected and process it to build and train an AI model and work towards achieving a baseline accuracy that helps in compiling a software tool that can be used as a preliminary diagnosis tool on a mass scale with less time consumption and very limited resources.Timepoint: Screening/Baseline Visit→ | | | | Yes | False | | |
| → | CTRI/2020/06/025674 | 27 January 2021 | Oral Fluid Sars-CoV-2 Ab Rapid test | Rapid point-of-care oral fluid screening test for Sars-CoV-2 antibodies to monitor COVID-19 disease. - O-CovAb | | Diabetes Research Society | 06-06-2020 | 20200606 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44431 | Not Recruiting | No | | | | 16-06-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Prof PV Rao→ | | Kumudini Devi Diabetes Research Center, Ramdevrao Hospital, Kukatpally → | Diabetes@DiaBaid.in→ | 9885051110→ | Kumudini Devi Diabetes Research Center→ | Inclusion criteria: 1. 18 years or older, men and women <br/ ><br>2. Subjects suspected or with symptoms of Sars-CoV-2 <br/ ><br>3. Subjects, 3 days after the onset of symptoms <br/ ><br>4. Smoking or non-smoking <br/ ><br>5. Subjects willing for participating in the study and providing informed consent <br/ ><br>→ | Exclusion criteria: Subjects on ventilators or lung support→ | Health Condition 1: A00-B99- Certain infectious and parasitic diseases
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | There is a significant positive correlation between presence or absence of (blood and salivary) antibodies (against Sars-CoV-19 virus) and, severity and duration of disease after onset of symptoms. It is expected to initially observe this relationship most strongly in individuals who have specific disease (RT-PCR confirmed COVID-19 disease) within 7 days of onset, and these antibodies continue to remain positive in recovery period, 21 days and much later for many more weeks.Timepoint: June 16-July 31, 2020→ | | | | Yes | False | | |
| → | CTRI/2020/06/025703 | 27 January 2021 | Knowledge, Attitude, Feelings and Behavior in Adolescents during COVID-19 | Knowledge, Attitude, Feelings and Behavior in Adolescents during COVID-19: A Web-based Cross-Sectional Study | | Dr Sameer Malhotra selfsponsored | 08-06-2020 | 20200608 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44358 | Not Recruiting | No | | | | 17-06-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | United States of America;Australia;India;New Zealand;Singapore;United Arab Emirates;United Kingdom→ | Shreya Singhal→ | | Department of Mental Health and Behavioural Sciences, Max Healthcare,
IMS OPD.
1, 2, Press Enclave Marg, Saket Institutional Area, Saket, New Delhi → | singhal.shreya21@gmail.com→ | 9810022980→ | Max Super Speciality Hospital, Saket, New Delhi→ | Inclusion criteria: 1. Participants between the age of 14-19 years of age <br/ ><br>2. Participants with minimum 8 years of education with basic knowledge of English <br/ ><br>→ | Exclusion criteria: Participants under the age of 14 years and above the age of 19 years <br/ ><br>→ | | Intervention1: NIL: NIL<br>→ | To understand the knowledge, attitude, feeling, coping and behavior of adolescents during the COVID-19 pandemic. Predominant emergent patterns of lifestyle, feeling and behavior will be noted.Timepoint: 1 month during the period of COVID-19 pandemic.→ | | | | Yes | False | | |
| → | CTRI/2020/06/025702 | 27 January 2021 | Clinical Trial On Mildly Symptomatic Covid -19 Patients And Health Care Workers Posted To Covid Wards
| A Prospective, Open Label, Three Arm, Single Center, Controlled Study To Assess The Immune-Boosting Activity Of Mulmina Mango And Mulmina Amla Orange Health Drink in Asymptomatic, mildly Symptomatic COVID-19 patients and health care workers posted to COVID w | | Jagdale industries pvt Ltd | 08-06-2020 | 20200608 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44376 | Not Recruiting | No | | | | 15-06-2020 | 120 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | Mr Raghavendra K V→ | | No 782, 15th Cross, I Phase, J.P.Nagar,
Bangalore - 560 0078. Karnataka, INDIA
→ | ashok@radiantresearch.in→ | 9880999297→ | Radiant Research Services Pvt. Ltd→ | Inclusion criteria: 1.Volunteer aged between 18-60 years (both inclusive) <br/ ><br>2.Clinical evidence of COVID-19 and Asymptomatic Mildly Symptomatic Covid -19 patients. <br/ ><br>3.Health Care Workers Posted to Covid Wards.→ | Exclusion criteria: 1.Pregnancy or breast feeding. <br/ ><br>2.Patients with preexisting severe systemic disease necessitating longterm medication. <br/ ><br>3.Evidence of significant uncontrolled comorbid disease, like diabetes Type I or II, which in the investigators opinion would jeopardize patient participation. <br/ ><br>4.History of cancer, including solid tumours, hematologic malignancies and carcinoma in situ. <br/ ><br>5. Any neurological congenital or acquired, vascular or systemic disorder which could affect any of the efficacy assessments. <br/ ><br>6. Participation in the current or previous treatment with any approved or investigational health supplements during the past 1 month. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: A.MulminaTM Mango: It is a immunoboosting drink <br>: Dose: 200ml<br>Dosage form: Oral Drink <br>Frequency : 2 times daily <br>Route of administrate : Orally<br>Total duration: 28 days <br><br>Intervention2: MulminaTM Amla Orange: It is a immunoboosting drink: Dose: 200ml Dosage form: Oral Drink Frequency : 2 times daily Route of administrate : Orally Total duration: 28 days<br>Control Intervention1: NIL: NIL<br>Control Intervention2: NIL: NIL<br>→ | To evaluate the efficacy of A & B health drinks as supplement in COVID-19 patients <br/ ><br>Serum Immuno biomarkers: <br/ ><br>Serum amyloid A â?? SAA, IL-4, IL-6, IFN-gamma, CRP,Lymphocyte Count-L & IgA <br/ ><br> Serum Antioxidant Markers: <br/ ><br>Superoxide dismutase (SOD),Catalase (CAT),Malondialdehyde (MDA),Glutathione (GSH) <br/ ><br>Timepoint: Day 0 to Day 28→ | | | | Yes | False | | |
| → | CTRI/2020/06/025704 | 27 January 2021 | Ulinastatin for COVID-19 in patients with breathlessness | A Phase 3, Prospective, Randomized, Open Label, Comparative, Clinical Study To Evaluate Efficacy And Safety Of Ulinastatin Plus Standard-Of-Care Compared To Standard-Of-Care In Treatment Of Acute Respiratory Distress Syndrome (ARDS) In Hospitalized COVID-19 Infection Patient | | Bharat Serums and Vaccines ltd | 08-06-2020 | 20200608 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44170 | Not Recruiting | No | | | | 01-07-2020 | 120 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | Phase 3 | India→ | Anirban Roychowdhury→ | | 3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai → | Anirban.roychowdhuryh@bharatserums.com→ | 022-45043456→ | Bharat serums and Vaccines LTd→ | Inclusion criteria: 1. Hospitalized adult aged >18-65 years inclusive <br/ ><br>2. Confirmed COVID-19 infection (RT â??PCR-test) <br/ ><br>3. Symptoms of mild or moderate ARDS <br/ ><br> <br/ ><br>(Ref: MoHFW/ ICMR Revised guidelines on clinical management of COVID-19- 31Mar2020)→ | Exclusion criteria: 1. Patients with history of HIV/HCV/HBV positive or immunocompromised or TB <br/ ><br>2. Patients with significant co-morbidities at screening, as judged by the treating Investigator <br/ ><br>3. Moribund state in which death is perceived to be imminent (â?¤48 hours) <br/ ><br>4. Known hypersensitivity to any component of the investigational product <br/ ><br>5. Pregnant or nursing (lactating) women. <br/ ><br>6. Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19). <br/ ><br>7. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs/convalescent plasma (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra). <br/ ><br>8. Participation in any other clinical study→ | Health Condition 1: J80- Acute respiratory distress syndrome
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ulinastatin with Standard of care<br>: Ulinastatin -IV infusion in a dose of 200,000 units (diluted in 100 ml of 0.9% saline) 3 times a day (Every 8 hours) for 7 days<br>SOC - Hydroxychloroquine (400mg BD â?? for 1 day followed by 200mg BD for 4 days) + Azithromycin (500 mg OD for 5 days).<br>Control Intervention1: Standard of care: SOC -Hydroxychloroquine (400mg BD â?? for 1 day followed by 200mg BD for 4 days) + Azithromycin (500 mg OD for 5 days).<br>→ | 1. Number of days of use of Mechanical Ventilation <br/ ><br>2. Change from baseline in PF ratio (PaO2/FiO2) <br/ ><br>Timepoint: 1. Number of days of use of Mechanical Ventilation <br/ ><br>2. Change from baseline in PF ratio (PaO2/FiO2) <br/ ><br>→ | | 07/11/2020 | | Yes | False | | |
| → | CTRI/2020/06/025714 | 27 January 2021 | Holistic Health Management through Yoga and Naturopathy for Frontline COVID Health Care Providers â?? The H2M trial | Holistic Health Management through Yoga and Naturopathy for Frontline COVID Health Care Providers â?? The H2M trial - The H2M Trial | | Government Yoga And Naturopathy Medical College and Hospital Chennai | 08-06-2020 | 20200608 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44020 | Not Recruiting | No | | | | 02-06-2020 | 1200 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | Dr Manavalan Narayanaswamy→ | | Department of Naturopathy, Government Yoga & Naturopathy
Medical College, Arignar Anna Indian Medicine Campus
Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India → | gynmcchennai@gmail.com→ | | Government Yoga AND Naturopathy Medical College→ | Inclusion criteria: 1. Doctors and healthcare workers of all ages irrespective of gender <br/ ><br>2. Willingness to participate <br/ ><br>→ | Exclusion criteria: Confirmed diagnosis of COVID-19 <br/ ><br>Explicit non-willingness to participate in the study <br/ ><br>→ | | Intervention1: Yoga & Naturopathy: 1. Prevalidated scientific yoga module comprising of asanas, pranayama, relaxation and meditation would be administered by a Government Yoga and Naturopathy physician for 6 days a week for 4 weeks as a recorded video.<br><br>2. A set of 5 simple lifestyle modification tips would be recommended to be followed by the participants in the <br>a. Drinking 1.5 â?? 2 litres of water everyday<br>b. Practicing mental silence for 10 minutes everyday<br>c. Diet to include sprouts, greens and vegetables daily and Making one meal a complete fruit diet atleast once a week<br>d. Hot water with salt and turmeric gargling once a day<br>e. Including natural immune boosting fresh juice (made of Indian Gooseberry, Ginger, Turmeric,tulsi and lemon) and natural immune boosting hot drink (made of ginger, tulsi, pepper, liquorice, turmeric) once a day.<br>Control Intervention1: Usual care: Usual care / No intervention<br>→ | 1. Perseverative Thinking Questionnaire <br/ ><br>2. GAD7 Questionnaire <br/ ><br>3. Pittsburg Sleep Quality Index <br/ ><br>4. Freiburg Mindfulness Inventory <br/ ><br>5. Qualitative assessments for Subjective perception of Stress and YogaTimepoint: 15 days and 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/06/025763 | 27 January 2021 | A Randomized controlled Clinical Trial to determine the efficacy of Siddha drugs in COVID 19 patients | A Randomized controlled Clinical Trial to determine the complementary effect of selected Siddha formulations in facilitating the possibility of accelerated recovery in COVID 19 patients. - SIDCOVID | | National institute of Siddha | 09-06-2020 | 20200609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44340 | Not Recruiting | No | | | | 17-07-2020 | 150 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Dr P Shanmugapriya→ | | National Institute of Siddha
Tambaram Sanatorium National Institute of Siddha
Tambaram Sanatorium→ | mmssiddha@gmail.com→ | 9940266442→ | National Institute of Siddha→ | Inclusion criteria: Male, Female and Transgenders. <br/ ><br>ï?· Age between 18 to 85 years <br/ ><br>ï?· COVID 19 positive asymptomatic / pre symptomatic, mild and moderately and severely symptomatic patients. <br/ ><br>ï?· Willing to consent to the study.→ | Exclusion criteria: High risk groups (Patients with Complications of Diabetes, Heart diseases, Cancer and Pregnancy) <br/ ><br>ï?· Multi organ failure Syndrome (MODS). <br/ ><br>ï?· Patients participating in other COVID 19 trials.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Kabasura kudineer, Nilavembu kudineer, Amukra churnam, Thalisadhichurnam, Adathodai Manappagu, Brahmanada Bhairavam Pills, Thippili Rasayanam, Maldevi Chenduram, Adathodai Kudineer, Nochi Kudineer, Thirikadugu Churnam, Adathodai Manappagu and Herbal Tea<br>: Thirikadugu Churnam, Adathodai Kudineer, Nochi Kudineer, Maldevi chenduram are for Moderate and Severe COVIDs and Nilavembu kudineer, Adathodai Manappagu, Brahmanada bairavam are exclusively for Mild covids<br>Control Intervention1: Standard of Care: Standard of Care with or without Siddha Placebo<br>→ | Primary Outcome would be measured through Reduction of symptoms and <br/ ><br>Recovery of patients from COVID 19 disease in a time bound manner.Conversion of RT PCR negative within first week of accelerated recoveryTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/06/025764 | 27 January 2021 | Assessment of depression, anxiety and coping strategies among Health care workers working in dedicated COVID-19 hospitals | Assessment of depression, anxiety and coping strategies among Health care workers working in dedicated COVID-19 hospitals | | Department of Psychiatry | 09-06-2020 | 20200609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44405 | Not Recruiting | No | | | | 22-06-2020 | 93 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Niteen Abhivant→ | | Department of Psychiatry, B. J. Government Medical College, Pune B-506, Navkar Residency, Bibvewadi, Pune. 411037→ | abhivantniteen@gmail.com→ | 8308806099→ | B.J.Government Medical College, Pune Maharashtra→ | Inclusion criteria: 1. Health care workers working at different levels in dedicated COVID-19 Hospital. <br/ ><br>2. Healthcare workers of both sexes will be included. <br/ ><br>3. Those who are willing to give consent.→ | Exclusion criteria: Those who are having pre-existing Psychiatric illness.→ | | | There will be increased level of depression and anxiety among healthcare workersTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/06/025766 | 27 January 2021 | A study of 254nm UVC ray therapy in pharynx for asymptomatic to mild cases of Corona Virus Disease | Oronasopharyngeal 254 nm ultraviolet C therapy for asymptomatic to mild cases of Corona Virus Disease-2019: A randomized controlled study | | Dr Jagdeep Kakadia | 09-06-2020 | 20200609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44171 | Not Recruiting | No | | | | 11-06-2020 | 300 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Dr Jagdeep Kakadia→ | | Akshardeep Eye Hospital
Besides Bahumali Bhavan
Neelambaug Road
Bhavnagar Besides Bahumali Bhavan
Neelambaug Road
Bhavnagar→ | dr_jmkakadia@yahoo.com→ | 9825206858→ | Akshardeep Eye Hospital→ | Inclusion criteria: 1 RT PCR confirmed asymptomatic or mild COVID-19 patients <br/ ><br>2 The voluntary willingness of the patient to give written <br/ ><br> informed consent prior to participation in the trial <br/ ><br>→ | Exclusion criteria: 1 History of known hypersensitivity to UV rays <br/ ><br>2 Patients with active oral ulcers <br/ ><br>3 Participating in any other clinical trial <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 254 nm ultraviolet C rays<br><br>: 254 nm ultraviolet C oronasopharyngeal exposure in dose of 2 mJ/cm2 once (repeat a dose if needed; maximum 2 doses) using a UV torch for 3 min add-on to the standard care<br><br><br>Control Intervention1: Standard care: Standard care for COVID 19 given to patients as per applicable guideline<br>→ | Proportion of patients virologicaly cured on (asymptomatic and mild cases) <br/ ><br>Proportion of patients clinically cured (mild cases)Timepoint: Day 1, 3, and 5→ | | | | Yes | False | | |
| → | CTRI/2020/06/025760 | 27 January 2021 | A clinical trial to study the effect of drug named Sofosbuvir in hospitalized patients with COVID 19. | Efficacy of Sofosbuvir in the management of hospitalized COVID 19 patients. | | Dr N Babu | 09-06-2020 | 20200609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44441 | Not Recruiting | No | | | | 17-06-2020 | 50 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Babu N→ | | B9IRIS, TIVOLI GARDENS,
Old no. 3, New no. 51,
Vadapalani,
Chennai. Vijaya Medical and Educational Trust, No 434, old no 180, N.S.K salai, Vadapalani, Chennai 600026→ | drbabunarayan@gmail.com→ | 7299252827→ | Vijaya Medical and Educational Trust→ | Inclusion criteria: Patients more than 18 years of age and proven COVID-19 by RT-PCR for SARS CoV-2 with one of the following criteria <br/ ><br>1. requiring hospitalization with acute organ dysfunction(or) <br/ ><br>2. SaO2 in room air <93% or need for supplemental oxygen support in any form(or) <br/ ><br>3. Infiltrates in Chest X rays or CT Chest or Ultrasound evidence of Pneumonia and <br/ ><br>→ | Exclusion criteria: 1. Patients with mild symptoms (only fever and cough) and no risk factors <br/ ><br>2. Or not requiring any hospitalization, <br/ ><br>3. patient with comorbid illnesses with less than 50% survival rate at 1 year (Chronic End Stage Organ Disease). <br/ ><br>4. Patient on dialysis or Chronic kidney disease stage 5 <br/ ><br>5. Patient on drugs: amiodarone, phenytoin, phenobarbital and rifampicin <br/ ><br>6.Patient with HBsAg (or) anti Hbc Antibody Positive <br/ ><br>7.Patient with anti HCV antibody positive <br/ ><br>8.Patient not willing to give consent. <br/ ><br>9. Pregnancy/ lactating women <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Drug sofosbuvir: sofosbuvir 400 mg twice daily for 10 days in all eligible study subjects along with standard of care including tablet hydroxy chloroquine 400 mg twice a day on day 1 followed by 200 mg twice a day upto day 5.<br>Control Intervention1: nil: nil<br>→ | mortality of the study subjectsTimepoint: during hospitalisation→ | | | | Yes | False | | |
| → | CTRI/2020/06/025768 | 27 January 2021 | An open label Randomized Controlled Clinical trial to Evaluate the Safety and Efficacy of selected Siddha formulations in patients diagnosed with COVID-19 | An open label Randomized Controlled Clinical trial to Evaluate the Safety and Efficacy of selected Siddha formulations in patients diagnosed with COVID-19 | | National Institute of Siddha | 09-06-2020 | 20200609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44445 | Recruiting | No | | | | 20-07-2020 | 200 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Dr G J CHRISTIAN→ | | NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI - 47 NATIONAL INSTITUTE OF SIDDHA, TAMBARAM SANATORIUM, CHENNAI - 47→ | christianvijila@gmail.com→ | 9962545930→ | NATIONAL INSTITUTE OF SIDDHA,→ | Inclusion criteria: Male, Female and Transgenders. <br/ ><br>ï?· Age between 18 to 85 years <br/ ><br>ï?· COVID 19 positive asymptomatic / pre symptomatic, mild, moderate and severe COVID patients. <br/ ><br>ï?· Willing to consent to the study.→ | Exclusion criteria: Patients who cannot take food or drugs orally. High risk groups (Patients with Complications of Diabetes â?? DKA, DN, Severe Heart diseases and Pregnancy) <br/ ><br> Patients with other severe medical conditions requiring intensive management. <br/ ><br> Other viral pneumonia <br/ ><br> Patients who have received organ transplantation in the past 6 months or planning surgery <br/ ><br> Patients with severe or critical covid-19 infections. <br/ ><br> Patients with any active malignancy <br/ ><br> Patients who have severe underlying diseases that affects survival, including blood diseases, <br/ ><br>dyscrasia, active bleeding, severe malnutrition, etc. <br/ ><br> Patients with allergic constitution, or patients allergic to investigational products <br/ ><br> Patients with a history of positivity for HIV, Hepatitis B and Hepatitis C at screening. <br/ ><br> Critical patients with life expectancy <48 hours <br/ ><br> Septicemia / Multi-organ failure Syndrome (MODS). <br/ ><br> Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal. <br/ ><br> Patients participating in other COVID 19 trials.→ | Health Condition 1: B342- Coronavirus infection, unspecified
→ | Intervention1: Kabasura kudineer, Amukkara churnam and Nellikai ilagam: Kabasura kudineer: 10gms of drug boiled with 240ml of water will be reduced to 60 ml, filtered and consumed within 3 hours. Decoction will be freshly prepared for every dose. <br>Convalescent medicine namely NELLIKAI ILAGAM 5gm BD and AMUKKARA CHURNAM 2gm BD. The intervention will be administered for 30 days or till the RT PCR becomes negative whichever is earlier<br>Intervention2: Kabasura kudineer, Amukkara churnam and Nellikai ilagam: Kabasura kudineer: 10gms of drug boiled with 240ml of water will be reduced to 60 ml, filtered and consumed within 3 hours. Decoction will be freshly prepared for every dose. <br>Convalescent medicine namely NELLIKAI ILAGAM 5gm BD and AMUKKARA CHURNAM 2gm BD.<br>Intervention3: In Mild & Asymptomatic COVIDs <br>Standard of care<br><br>Kabasura Kudineer (5g) Nilavembu kudineer (5g) - 60ml tid in symptomatics & bid in<br>asymptomatics<br><br>Amukkura churnam 2g <br> Thalisathi Churnam (2g) â?? 4g tid with honey or milk (in diabetics)<br><br>Adathodai Manappagu 20ml bid with water<br><br>Karuppu Vishnu chakram 2 pills bd with honey<br><br>Nellikkai Leghyam 5g bid<br><br>Herbal tea with diet<br><br>For Moderate and Severe patients<br>Along with Standard of care,<br><br>Adathodai Kudineer (5g) Nochi Kudineer (5g) â?? 60ml tid<br>Amukkura churnam 2g Thalisathi Churnam (2g) â?? 4g tid with honey or milk (in diabetics)<br><br>Maldevi (Thaalaga) chenduram 100 mg bid with honey<br><br>Pavala parpam 100mg bd with honey<br><br>Thippili rasayanam 5g bid<br><br>Herbal tea with diet: Duration Test drug will be given till clinical recovery or 30 days<br>whichever is earlier and the general conventional management and the Siddha convalescent advisory medicines (Nellikai legiyam, Amukkra chooranam) will be continued as deemed necessary. <br><br>Single Dose <br>Kudineer 10gms of drug boiled→ | Primary Outcome would be measured through Resolution of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment at specific time points. RT PCR conversion within first week with accelerated recovery as compared to control groupTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/06/025761 | 27 January 2021 | Population based cross sectional study for COVID 19 prophylaxis with
Polyherbal Siddha formulation Kabasura Kudineer / Nilavembu kudineer in containment zones and non
containment zones during 2020 pandemic in Tamil Nadu, South India | Population based cross sectional study for COVID 19 prophylaxis with
Polyherbal Siddha formulation Kabasura Kudineer / Nilavembu kudineer in containment zones and non
containment zones during 2020 pandemic in Tamil Nadu, South India | | National Institute of Siddha | 09-06-2020 | 20200609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44258 | Not Recruiting | No | | | | 15-06-2020 | 10000 | Observational | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr G J Christian→ | | national institute of siddha
tambaram sanatorium national institute of siddha
tambaram sanatorium→ | christianvijila@gmail.com→ | 9962545930→ | National institute of Siddha→ | Inclusion criteria: a) Laboratory confirmed COVID-19 with or without symptoms <br/ ><br>b) Those who are to be excluded in the study, as evaluated by the investigators. <br/ ><br>c) Persons intaking Kabasura kudineer / Nilavembu kudineer procured from non GMP <br/ ><br>certified pharma companies. <br/ ><br>7 <br/ ><br>d) Persons with poor drug compliance→ | Exclusion criteria: a) Laboratory confirmed COVID-19 with or without symptoms <br/ ><br>b) Those who are to be excluded in the study, as evaluated by the investigators. <br/ ><br>c) Persons intaking Kabasura kudineer / Nilavembu kudineer procured from non GMP <br/ ><br>certified pharma companies. <br/ ><br>7 <br/ ><br>d) Persons with poor drug compliance→ | | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | COVID-19 Test Positivity / Negativity upto 31 days follow up.Timepoint: COVID-19 Test Positivity / Negativity upto 31 days follow up.→ | | | | Yes | False | | |
| → | CTRI/2020/06/025762 | 27 January 2021 | An Open-Label Randomized Controlled, Proof-of-Concept (PoC) Study to
Evaluate the Safety and Efficacy of selected Siddha formulations in patients
diagnosed with COVID-19 | An Open-Label Randomized Controlled, Proof-of-Concept (PoC) Study to
Evaluate the Safety and Efficacy of selected Siddha formulations in patients
diagnosed with COVID-19 | | National Institute of Siddha | 09-06-2020 | 20200609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44259 | Not Recruiting | No | | | | 15-06-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | Phase 3 | India→ | Dr G J Christian→ | | national institute of siddha
tambaram sanatoriuN national institute of siddha
tambaram sanatorium→ | christianvijila@gmail.com→ | 9962545930→ | National Institute of Siddha→ | Inclusion criteria: ï?· Male, Female and Transgenders. <br/ ><br>ï?· Age between 18 to 85 years <br/ ><br>ï?· COVID 19 positive asymptomatic / pre symptomatic, mild and moderately symptomatic patients. <br/ ><br>ï?· Willing to consent to the study.→ | Exclusion criteria: Patients who have received organ transplantation in the past 6 months or planning surgery.Patients with severe or critical covid-19 infections.Patients with any active malignancy. Patients who have severe underlying diseases that affects survival, including blood diseases,dyscrasia, active bleeding, severe malnutrition, etc. <br/ ><br>Patients with allergic constitution, or patients allergic to investigational products <br/ ><br>Patients positive for HIV, Hepatitis B and Hepatitis C at screening.Critical patients with life expectancy <48 hours. Septicemia / Multi organ failure Syndrome (MODS).Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal.Patients participating in other COVID 19 trials.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Kabasura kudineer; Amukkara choornam; Nelikai legiyum: KS kudineer will be administered twice a day in<br>asymptomatic COVID patients; and will<br>be administered thrice a day in symptomatic<br>individuals just before or after food. Apart from this medication, Convalescent medication is prescribed namely Amukkara choornam 2gms bid and Nellikkai ilagam 5gms bid for 15 days.<br>Control Intervention1: Not applicable: Not applicable<br>→ | Outcome would be measured through Reduction of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment at specific time points.Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/06/025769 | 27 January 2021 | A prophylactic interventional study to determine the possible protective effect of Siddha Polyherbal formulation Kabasura Kudineer against the COVID 19 on
intermittent, month-long consumption by public with close contacts to COVID patients and frontline workers in Tamil Nadu, India | A prospective Non randomized open label controlled intervention study on the effect of Polyherbal Siddha formulation Kabasura kudineer as a prophylactic measure among high risk population (Health care workers/ Containment zone population) exposed to COVID 19 | | National institute of Siddha Ministry of AYUSH | 09-06-2020 | 20200609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44260 | Recruiting | No | | | | 15-06-2020 | 40000 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Dr N J Muthukumar→ | | National Institute of Siddha
Tambaram Sanatorium National Institute of siddha
Tambaram Sanatorium→ | drsureshherbal@gmail.com→ | 9962571137→ | National institute of Siddha→ | Inclusion criteria: All the willing frontline health workers, police personnel and other public servants inclusive of those with direct / primary contacts with COVID positives (High risk and moderate risk exposures).→ | Exclusion criteria: Not willing to sign informed consent. <br/ ><br>Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study.→ | | Intervention1: Kabasura kudineer: 5- 10gms of Kabasura kudineer drug boiled with 240ml of<br>water will be reduced to 60 ml, filtered and<br>Consumed within 3 hours. Concoction will<br>be freshly prepared for every dose.<br>Time of Administration: This dose will be administered once a day just before or after food.<br>Control Intervention1: Standard of Care: General public and frontline workers who have taken/given Allopathic Standard of Care like Vitamins and/or other drugs for Covid prevention.<br>→ | Percentage of participants protected during the outbreak of COVID 19 compared between the Kabasura Kudineer taken and Standard of Care taken groupsTimepoint: Assessment will be done at Baseline and 30th day from the start of Prophylactic intervention.→ | | | | Yes | False | | |
| → | CTRI/2020/06/025801 | 27 January 2021 | Role of Herbal Immunomodulators in mild COVID-19 confirmed cases | A Clinical Study to Evaluate the role of Herbal Immunomodulators (Tab Septilin and Tab Bresol) as add on treatment in Asymptomatic and mildly symptomatic COVID-19 confirmed cases | | The Himalaya Drug Company | 10-06-2020 | 20200610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44293 | Not Recruiting | No | | | | 19-06-2020 | 40 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Soorya Narayan H→ | | Room No 301,3rd Floor
Clinical
Phramacology.
Reserach and Development Makali,Tumkur Road, → | dr.palani@himalayawellness.com→ | | The Himalaya Drug Company→ | Inclusion criteria: 1.Subjects who are COVID-19 confirmed cases, with mild severity presenting with signs and symptoms qualifying for Low Clinical Risk (News Scoring 0-4) <br/ ><br>2. Subjects with SARS-CoV-2 RT-PCR confirmed COVID-19 positive within 7 days from symptom onset or Patients within 48 hours after laboratory diagnosis (SARS-CoV-2 RT-PCR). <br/ ><br>3.Female of childbearing potential willing to follow reliable and strict contraceptive measures. <br/ ><br>4.Subject judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment and compliance to quarantine procedure (as per prevailing guidelines). <br/ ><br>5. Able to give written inform consent to participate in the study. <br/ ><br>→ | Exclusion criteria: 1.Confirmed COVID-19 positive cases with NEWS scoring system â?¥5. <br/ ><br>2.Individual with acute respiratory distress presenting with RR > 24/mt, SaO2/SPO2â?¤94% in room air condition, or the Pa02/Fi02 ratio <300mgHg. <br/ ><br>3.Pregnant or breastfeeding females. <br/ ><br>4.Recent history of significant lung disease like Asthma or Chronic Obstructive Lung Disease (COPD). <br/ ><br>5.Unable to take oral medication or suffering from ailments related to absorption. <br/ ><br>6.Suffering from Immunocompromising conditions or taking any immunosuppressing therapy. <br/ ><br>7.Subjects suffering from severe and uncontrolled metabolic, endocrinal, cardiac/ renal/liver disease. <br/ ><br>8.The subject with known hypersensitivity to any of the test materials or related compounds. <br/ ><br>9.The subject who are unable or unwilling to comply fully with the study protocol. <br/ ><br>10.Physician makes a decision that trial involvement is not in patients best interest, or any condition that does not allow the protocol to be followed safely. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tab. Bresol and Tab. Septilin: Each tablet is recommended at a dose of 1 tablet twice daily orally (BD) for the specified duration of treatment (from day 1 upto14 days from the discharge from the hospital, as applicable).<br>Control Intervention1: Not applicable: Not Applicable<br>→ | Time to Clinical Recovery <br/ ><br>No. & Percentage (%) of subjects converting into severe cases. <br/ ><br>Time to convert 2019 nCoV RT PCR in negative in upper respiratory tract specimen <br/ ><br>Lenth of Hospital stay <br/ ><br>Proportion of clinical failure -ICU admission, mechanical ventilation or death <br/ ><br>Number & Percentage (%) of subjects converting into positive test for COVID-19 <br/ ><br>Protection as defined by various laboratory parameters related to inflammation and immunity <br/ ><br>Overall well-beingTimepoint: Visit-1 Baseline <br/ ><br>Visit-2 Date of discharge <br/ ><br>Visit-3(Telephonic) 7 days from the date of discharge±1day <br/ ><br>Visit-4 14 days from the date of discharge ±3day <br/ ><br>(EOS)→ | | 25/08/2020 | | Yes | False | | |
| → | CTRI/2020/06/025796 | 27 January 2021 | Effect of aragwadhadi kwath (kadha in Hindi) in treatment of mild corona virus disease | Efficacy and Safety of aragwadhadi kwath mentioned in bhavprakash jwarachikitsa 1/155 in mild COVID-19 patients: A randomized controlled study | | VaidhyaTushar Trivedi | 10-06-2020 | 20200610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44181 | Not Recruiting | No | | | | 15-06-2020 | 90 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Vaidhya Tushar Trivedi→ | | Ayurveda Consultant and Panchakarma Physician
Sanjivani Ayucare, Bhavnagar, Gujarat, India
Bhavnagar, Gujarat, India→ | vdtushartrivedi@gmail.com→ | 9426989485→ | Sanjivani Ayucare→ | Inclusion criteria: 1 Male or non-pregnant females aged â?¥ 18 years with mild COVID-19 disease based on positive RT- PCR test. <br/ ><br>2 Voluntary willingness of patient to give written informed consent prior to participation in trial. <br/ ><br>→ | Exclusion criteria: 1 Pregnant lady or Lactating mother <br/ ><br>2 History of known hypersensitivity to study drugs <br/ ><br>3 Corona positive patient with severe diarrhoea or Vomiting <br/ ><br>4 Known case of Diabetes Mellitus <br/ ><br>5 Participating in any other clinical trial or Receiving any other medicines of alternative system→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J100- Influenza due to other identifiedinfluenza virus with pneumonia
→ | Intervention1: Aragwadhadi kwath mentioned in bhavprakash jwarachikitsa 1/155: 80 ml lukewarm decoction of cassia fistula (fruit pulp), piper longum (root), cyperus rotundus (tubers), terminalia chebula (fruit) and picrorhiza kurroa (root) 12 hrly daily orally for 14 days add on to standard care<br>Control Intervention1: Standard care alone: Standard treatment given as per treatment guideline<br>→ | Proportion of Clinically and Virologically cured patientsTimepoint: at Day 5, 10 and 14→ | | | | Yes | False | | |
| → | CTRI/2020/06/025798 | 27 January 2021 | A Clinical trial to establish the appropriate line of management of Non Muscle Invasive Bladder Cancers who have had their intravesical BCG therapy interrupted | An open label multi-centre randomized control trial for reinitiating intravesical BCG therapy vs resumption in patients of Non Muscle Invasive Bladder Cancer with interruption of therapy due to the COVID-19 (ICON STUDY)
- ICON | | None | 10-06-2020 | 20200610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44460 | Not Recruiting | No | | | | 18-06-2020 | 70 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 4 | India→ | Tushar Aditya Narain→ | | Department of Urology,
Level 6, Medical College,
AIIMS, Rishikesh → | aditya.tushar@gmail.com→ | 8146690201→ | AIIMS, Rishikesh→ | Inclusion criteria: 1. Patients aged more than 18 years <br/ ><br>2. Patients having high risk NMIBC (T1 or CIS or HG, {multiple, recurrent, and large TaG1G2 all features must be present} ) and Intermediate risk (TaG1/G2 with multiple, recurrent, large tumour) (according to EAU risk stratification) who were planned for BCG therapy but not started. <br/ ><br>3. Patients who have received intravesical BCG therapy and whose treatment was not complete as on 25th March, 2020 <br/ ><br>→ | Exclusion criteria: 1.Low risk group (Ta LG, < 3cm, solitary, no CIS) (according to EAU risk stratification) <br/ ><br>2.History of BCG intolerance <br/ ><br>3.Patients who have completed BCG intravesical therapy as on march 25th, 2020. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C679- Malignant neoplasm of bladder, unspecified
→ | Intervention1: Intervention Arm 1: Reinitiation of intravesical BCG from the beginning of the regimen<br>120 mg of intravesical BCG dissolved in 50 ml Normal Saline instilled in bladder via a per urethral catheter, weekly for 6 weeks followed by monthly for 12 months<br>Control Intervention1: Intervention Arm 2: Resumption of Intravesical BCG from where it was interrupted<br>120 mg of intravesical BCG dissolved in 50 ml Normal Saline instilled in bladder via a per urethral catheter, weekly for 6 weeks followed by monthly for 12 months, depending upon from where in the course, the therapy was resumed<br>→ | 1. To determine the recurrence rates, grade and stage progression in NMIBC patients with restarting the intravesical BCG regimen versus continuing the regimen, stratified by different phases of interruption. <br/ ><br>Timepoint: At completion of accrual, 1 year, 3 years and 5 years <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/06/025779 | 27 January 2021 | Study of AYUSH KWATH in quarantine persons | Evaluation of the efficacy of AYUSH KWATH in the prevention of COVID-19 pandemic among quarantine persons â?? an open label single arm prospective study | | Dr SR Rajasthan Ayurveda UniversityJodhpurRaj | 10-06-2020 | 20200610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44463 | Not Recruiting | No | | | | 17-06-2020 | 50 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Prof Dr Abhimanyu Kumar→ | | Office of the Vice Chancellor, Room no 101, Dr SR Rajasthan Ayurveda University, Nagaur Road, Karwar,Jodhpur(Raj.) → | vc.dsrrau@gmail.com→ | 8800543828→ | Dr SR Rajasthan Ayurveda University,Jodhpur(Raj.)→ | Inclusion criteria: 1. All persons who got admitted in Quarantine center of 20 to 60 years willing to participate, with or without co-morbid condition with exposure/chance of exposure to COVID 19 positive cases. <br/ ><br>2. Who are willing to provide signed informed consent→ | Exclusion criteria: 1. Pregnant and lactating females. <br/ ><br>2. Known case of Carcinoma lungs, CRF and CHF. <br/ ><br>3. Participants with any immunosuppressive medication or in an immune compromised state or hematological disease. <br/ ><br>4. Laboratory confirmed COVID-19 with or without symptoms. <br/ ><br>5. DM uncontrolled with medications. <br/ ><br>6. Any other criteria, as per the investigator would jeopardize the study.→ | | Intervention1: Drug Interventions (Ayush Kwath): 1. Tulasi (Ocimum sanctum) Leaves 4 parts<br>2. Dalchini (Cinnamomum zeylanicum ) Stem bark 2 parts<br>3. Shunthi (Zingiber officinalis) Rhizome 2 parts<br>4. Krishna Marich (Piper nigrum) Fruit 1 part<br><br>Dose: 3gm, twice a day with 150ml warm water in KWATH form. <br><br>Route of Administration: Oral<br><br>Time of Administration: Twice in a day- On empty stomach in the<br>morning at least 1 hour before breakfast and two hours after dinner at night.<br><br>Duration of Therapy: 30 days<br>Control Intervention1: SINGLE ARM: NOT APPLICABLE<br>Control Intervention2: NOT APPLICABLE: NOT APPLICABLE<br>→ | Percentage of participants with SARS- Cov-2 positivity and Number/ percentage of participants not developing any Covid-19 like sign & symptoms (Time line 30 days)Timepoint: Percentage of participants with SARS- Cov-2 positivity and Number/ percentage of participants not developing any Covid-19 like sign & symptoms (Time line 30 days)→ | | | | Yes | False | | |
| → | CTRI/2020/06/025802 | 27 January 2021 | COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study | COVID-19 and liver injury in patients with or without underlying liver disease: A multi-centre retrospective-prospective observational study | | Max Super Speciality Hospital | 10-06-2020 | 20200610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44476 | Not Recruiting | No | | | | 17-06-2020 | 314 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Rajesh Saxena→ | | Max Super Speciality Hospital Mandir Marg Press enclave Road Saket New Delhi-110017 Max Super Speciality Hospital Mandir Marg Press enclave Road Saket New Delhi-110017→ | Saroj.kumar@maxhealthcare.com→ | 9999325464→ | Max Super Speciality Hospital→ | Inclusion criteria: All patients infected with SARS-CoV-2 and admitted to the COVID-19 ward/ICU of Max Hospital Saket (either in East Wing , Max Super Specialty Hospital, Saket or MAX Smart Super Specialty Hospital, Saket) between 1/4/2020 to 30/6/2020 (retrospective data between 1/4/2020- 30/4/2020 & prospective data from approval till 30/6/2020), will be included.→ | Exclusion criteria: 1. Patients less that 18 years old with COVID-19 <br/ ><br>2. Pregnant ladies with COVD-19 <br/ ><br>3. Unwilling to give consent for inclusion <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | â?¢ Prevalence of liver injury in patients infected with SARS-CoV-2 virus. <br/ ><br>â?¢ Prevalence of new liver injury in patients having COVD-19 infection over underlying liver dis-eases. <br/ ><br>Timepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/06/025799 | 27 January 2021 | A study of Favipiravir in patients with mild to moderate coronavirus disease (COVID-19)
| A Randomized, Open Label, Prospective, Comparative, Parallel Group,
Multicentre Study To Evaluate Efficacy And Safety Of Favipiravir With
Supportive Care Versus Supportive Care Alone In Subjects With Mild To
Moderate Coronavirus Disease (COVID-19).
- NA | | Cipla Ltd | 10-06-2020 | 20200610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44480 | Not Recruiting | No | | | | 17-06-2020 | 156 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3 | India→ | Mr Abhijit Vaidya→ | | Cipla Ltd., 289 Bellasis Road, Mumbai Central East, Mumbai, Maharashtra 400008, India. → | sandesh.sawant3@cipla.com→ | 022-23025193→ | Cipla Ltd→ | Inclusion criteria: 1. A voluntarily given written signed dated informed consent from subjects and/or legally acceptable representative. <br/ ><br>2. Subjects of either gender and age between 18 and 75 years. <br/ ><br>3. Confirmed diagnosis of mild to moderate COVID-19. (positivity in RTPCR <br/ ><br>2019-nCoV test on respiratory tract specimens). <br/ ><br>4. In case of moderate COVID-19, subjects with CT or Chest X-ray <br/ ><br>documented pneumonia. <br/ ><br>5. Subjects with pyrexia (axillary â?¥37â?? or oral â?¥37.5â??, or rectalâ?¥38â??) <br/ ><br>or either respiratory rate >24/min and <30/min or cough. <br/ ><br>6. Subjects within 7 days from symptom onset or within 48 hours of <br/ ><br>laboratory diagnosis of SARS-CoV2. <br/ ><br>→ | Exclusion criteria: 1. Subjects with known allergy or hypersensitivity to Favipiravir or any of its components or to supportive care. <br/ ><br>2. Subjects with Chronic liver disease (Child Pugh class B or C) and chronic renal disease (GFR <30ml/min). <br/ ><br>3. Subjects with oxygen saturation (SPO2) â?¤90% or arterial oxygen <br/ ><br>partial pressure (PaO2)/ fraction of inspired O2 (FiO2) â?¤300 mmHg. <br/ ><br>4. Refractory nausea, vomiting, or chronic gastrointestinal disorders, <br/ ><br>inability to swallow the study drug or having undergone extensive <br/ ><br>bowel resection which may affect adequate absorption of Favipiravir. <br/ ><br>5. Subjects with gout or hyperuricemia. <br/ ><br>6. Pregnant or breast-feeding subjects. <br/ ><br>7. Subject is using adrenocorticosteroids (except topical or inhaled <br/ ><br>preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ ><br>8. Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days. <br/ ><br>9. Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ ><br>10. Subject has a psychiatric disease that is not well controlled where <br/ ><br>controlled is defined as: stable on a regimen for more than one year. <br/ ><br>11. Subject already treated with another COVID 19 therapy but has <br/ ><br>relapsed with a positive diagnosis. <br/ ><br>12. Anticipated transfer to another hospital which is not a study site <br/ ><br>within 72 hours. <br/ ><br>13. Participated in any other clinical trial or taken investigational drug <br/ ><br>within 1 month. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Favipiravir 200 mg oral tablets: 1800 mg twice daily on Day 1 and 800 mg twice daily from Day 2<br>upto maximum 14 days along with supportive care<br><br><br>Control Intervention1: Supportive care alone: Supportive care alone<br>→ | Time from randomization to negativity in RT-PCR nucleic acid test. [defined as the presence of two consecutive negative results with RT-PCR detection over an interval of 24 hour]Timepoint: Up to 28 days→ | | | | Yes | False | | |
| → | CTRI/2020/06/025800 | 27 January 2021 | Role of Ayurveda in Covid 19 management. | A comparative clinical study to involving Ayurvedic drug intervention in the management of COVID 19 patients. | | National Health Mission Uttar Pradesh | 10-06-2020 | 20200610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44485 | Not Recruiting | No | | | | 22-06-2020 | 120 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Adil Rais→ | | Panchakarma Unit
Room no 114
Lokbandhu Rajnarayan Combined Hospital Lokbandhu Rajnarayan Combined Hospital→ | adil.rais13@gmail.com→ | 7060272769→ | LokBandhu Rajnarayan Combined Hospital→ | Inclusion criteria: Patients tested Positive for COVID 19. <br/ ><br>Asymptomatic Patients or with Mild Symptoms. <br/ ><br>Those willing to give informed Consent.→ | Exclusion criteria: Patients below 25 years and above 60 years of age. <br/ ><br>Patients presenting with increased severity of disease. <br/ ><br>Those having serious Comorbidities, including Diabetes, Hypertension. <br/ ><br>Pregnant Women <br/ ><br>those not willing to give consent <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Shunthi and Rasona (Group B): Shunthi churna 2 gm twice daily for 10 days<br>Rasona kalka 1 gm once daily with warm water for 10 days<br>Intervention2: Kashaya Group (Group A): Vyaghryadi kashaya 50 ml BD for 10 days<br>Samshamani Vati 500 mg BD for 10 days<br>Agnikumara Rasa 125 mg BD for 10 days<br>Control Intervention1: Control Group (Group C): Warm water and Vitamin C tablet once daily for 10 days<br>→ | To reduce Virus Clearance Time. <br/ ><br>To improve General Quality of Life. <br/ ><br>To minimise the chances of Disease progression in terms of Severity. <br/ ><br>To assess role of Ayurveda medicines in the COVID 19 Pandemic management. <br/ ><br>To establish Ayurvedic drugs role in National programme for COVID managementTimepoint: 5 days and 10 days→ | | 30/06/2020 | | Yes | False | | |
| → | CTRI/2020/06/025797 | 27 January 2021 | Quality of Life During COVID-19 Lockdown | Quality of Life in Cancer Patients on Palliative Care During COVID-19 Lockdown Phase | | Dr Anuja Pandit | 10-06-2020 | 20200610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43759 | Not Recruiting | No | | | | 13-06-2020 | 54 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable | N/A | India→ | Anuja Pandit→ | | Academic Block, National Cancer Institute, Badsa All India Institute of Medical Sciences, Jhajjar, Haryana
→ | anujapandit@yahoo.co.in→ | 9710030457→ | Department of Onco-anesthesia and Palliative Medicine→ | Inclusion criteria: Adult Patients registered with NCI palliative care outpatient clinic.Patients who give informed consent→ | Exclusion criteria: Patients who do not understand Hindi or English→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | | To Evaluate the Quality of Life in Cancer Patients on Palliative Care during Lockdown in the COVID-19 PandemicTimepoint: From 25th March 2020 to 8thJune 2020→ | | | | Yes | False | | |
| → | CTRI/2020/06/025804 | 27 January 2021 | Effectiveness of lying face down in improving the outcome of COVID-19 patients | Effectiveness of awake self proning strategy in COVID-19: An open-labelled randomized controlled trial | | AIIMS Jodhpur | 11-06-2020 | 20200611 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44572 | Not Recruiting | No | | | | 20-06-2020 | 120 | Interventional | Randomized, Crossover Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | N/A | India→ | Dr Maya Gopalakrishnan→ | | Room 41, B block, OPD ground floor, AIIMS_Jodhpur, MIA Phase 2, Basni → | maya.gopalakrishnan@gmail.com→ | 9994492075→ | All India Institute of Medical Sciences- Jodhpur→ | Inclusion criteria: 1. >18 years of age <br/ ><br>2. Diagnosed as COVID-19 positive by RT- PCR <br/ ><br>3. Oxygen saturation < 94% as assessed by pulse oximeter or requiring oxygen support <br/ ><br>4. Can communicate and self-prone→ | Exclusion criteria: 1. Any patient requiring immediate intubation and ventilatory care <br/ ><br>2. Hemodynamic instability BP < 90/60 mm Hg or on inotrope support <br/ ><br>3. Elevated intracranial pressure <br/ ><br>4. Altered sensorium or history of seizures <br/ ><br>5. Any psychiatric comorbidity <br/ ><br>6. Massive hemoptysis in the last 48 hours ( >500 ml or requiring transfusion) <br/ ><br>7. Morbid obesity where self-proning is not feasible <br/ ><br>8. Pregnancy <br/ ><br>9. Patients at high risk of requiring CPR or defibrillation (Known arrhythmias)→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Awake self proning strategy: The COVID-19 patient will be asked to be in prone position and its effect on improvement of their blood oxygenation will be seen using a finger saturation probe.<br>Control Intervention1: Lying supine or sitting: The COVID-19 patient will be lying supine or sitting and its effect on improvement of blood oxygenation will be seen using a finger saturation probe.<br>→ | Primary outcomes (Phase 1 study): <br/ ><br>1. Oxygen saturation measured using by pulse oximeter at 0, 10, 20, 30, 40 minutes <br/ ><br>Primary Outcomes (Phase 2 study): <br/ ><br>1. Need for endotracheal intubation and mechanical ventilation measured at discharge or death <br/ ><br>2. Mortality up to 30 days after enrolmentTimepoint: Primary outcomes (Phase 1 study): <br/ ><br>1. Oxygen saturation measured using by pulse oximeter at 0, 10, 20, 30, 40 minutes <br/ ><br>Primary Outcomes (Phase 2 study): <br/ ><br>1. Need for endotracheal intubation and mechanical ventilation measured at discharge or death <br/ ><br>2. Mortality up to 30 days after enrolment→ | | | | Yes | False | | |
| → | CTRI/2020/06/025803 | 27 January 2021 | Effect of convalescent plasma in COVID-19 patients | Efficacy of Convalescent Plasma Therapy in Patients With COVID-19: A Randomized Control Trial | | Institute of Liver and Biliary Sciences | 11-06-2020 | 20200611 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44478 | Recruiting | No | | | | 18-06-2020 | 400 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 3 | India→ | Dr Meenu Bajpai→ | | Room No:16056, Department of Transfusion Medicine, Phase I,Upper Basement, D-1, Vasant Kunj New Delhi-110070
→ | meenubajpai@hotmail.com→ | 01146300000→ | Institute of Liver and Biliary Sciences→ | Inclusion criteria: Recipient Inclusion Criteria: <br/ ><br> <br/ ><br>- Patients with severe COVID-19 will be considered for randomization and will be transfused convalescent plasma within 3 days of symptom onset (Severe COVID-19) Severe COVID -19 defined by WHO Interim Guidance and the Guideline of Diagnosis and Treatment of COVID-19 of National Health Commission of China (version 5.0) along with confirmation by real-time RT-PCR assay with severe disease i.e. meeting any 2 of the following criteria- <br/ ><br> <br/ ><br>Patients on ventilator (in last 24 hours) <br/ ><br>Respiratory distress, RR greater than or equal to 30 beats/min <br/ ><br>Oxygen saturation level less than 90 % in resting state <br/ ><br>Partial pressure of oxygen (PaO2)/oxygen concentration (FiO2) less than or equal to 300 mmHg <br/ ><br>Lung infiltrates > 50% within 24 to 48 hours <br/ ><br>Donor Inclusion Criteria for Plasmapheresis <br/ ><br> <br/ ><br>Virologically documented (PCR positive by nasopharyngeal swab) who is recovered and free of symptoms for 14 days. <br/ ><br>Has tested negative for SARS CoV 2 on two consecutive tests 24 hrs apart. <br/ ><br>Fulfill all criteria of donor eligibility for donor Plasmapheresis under the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020 <br/ ><br>Females who have been pregnant may be tested for anti-HLA antibodies and eligible if negative for the same.→ | Exclusion criteria: Recipient Exclusion Criteria: <br/ ><br> <br/ ><br>Patient/ family members who do not give consent to participate in the study. <br/ ><br>Patients with age less than 18 years <br/ ><br>Patients presenting with multi-organ failure <br/ ><br>Pregnancy <br/ ><br>Individuals with HIV and Viral Hepatitis and Cancer <br/ ><br>Extremely moribund patients with an expected life expectancy of less than 24 hours <br/ ><br>Hemodynamic instability requiring vasopressors <br/ ><br>Previous history of allergy to plasma <br/ ><br>Cirrhosis <br/ ><br>Severe renal impairment with GFR < 30ml/min or recipients of RRT, peritoneal dialysis <br/ ><br>Patients with uncontrolled diabetes mellitus, hypertension, arrhythmias and unstable Angina <br/ ><br>Donors Exclusion Criteria: <br/ ><br> <br/ ><br>Do not fulfill all criteria of donor eligibility for donor Plasmapheresis under <br/ ><br>the Drugs & Cosmetics Act 1940 and Rules 1945, amended 11.03.2020 <br/ ><br>Females who have been pregnant and have not been tested for HLA antibodies or are HLA antibody positive if tested and previously transfused donors (to prevent TRALI) <br/ ><br>Donors who have taken steroids during treatment for COVID-19→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Convalescent Plasma with Standard of Care: Convalescent Plasma: Dose-250 ml Frequency - 2 doses on consecutive days Duration -Start by day 3 of symptom onset (of severe COVID-19 as in inclusion criteria) in eligible patients<br><br>Standard of Care: <br>The Ministry of Health and Family Welfare has issued detailed guidelines for the management of sCOVID-19 based on varying grades of severity which may be periodically updated. For the management of ARDS or sepsis the respective guidelines issued by ARDSNet and Surviving Sepsis campaign will be followed. Other institutional protocols for supportive management will be implemented. (Ref: Guidelines on Clinical Management of COVID-19. MoHFW, GoI.2020.)<br>Control Intervention1: Standard of Care<br>: Standard of Care: <br>The Ministry of Health and Family Welfare has issued detailed guidelines for the management of sCOVID-19 based on varying grades of severity which may be periodically updated. For the management of ARDS or sepsis the respective guidelines issued by ARDSNet and Surviving Sepsis campaign will be followed. Other institutional protocols for supportive management will be implemented. (Ref: Guidelines on Clinical Management of COVID-19. MoHFW, GoI.2020.)<br>→ | efficacy of convalescent plasma in severe COVID 19 patients in time to clinical improvement (Clinical improvement: Reduction of two points in ordinal scale or live discharge from the intensive care unit, whichever is earlier) <br/ ><br>Timepoint: Day 28→ | | | | Yes | False | | |
| → | CTRI/2020/06/025848 | 27 January 2021 | Clinical Analysis of Patients Hospitalized Due To Covid-19 | Clinical Analysis of Patients Hospitalized Due To SARS-CoV-2 (Covid-19) | | TNMC BYL Nair Hospital | 12-06-2020 | 20200612 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44593 | Not Recruiting | No | | | | 21-06-2020 | 1500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rakesh Bhadade→ | | Department of Medicine Nair Hospital→ | minalharde@yahoo.co.in→ | 02223027137→ | Topiwala National Medical College and BYL Nair Ch Hospital→ | Inclusion criteria: consecutive Covid-19 patients admitted during the study period will be enrolled in the study.→ | Exclusion criteria: children less than 18 years→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | All Covid -19 Patients will be stratified according to demographic parameters, clinical symptoms, co-morbidities, clinical course, laboratory, and radiological features, treatment given, ICU care, complications, and outcome (discharge or death). We aimed to compare the above parameters in different clinical outcomes.Timepoint: Death Or Discharge→ | | | | Yes | False | | |
| → | CTRI/2020/06/025849 | 27 January 2021 | Study to Evaluate the Safety and Efficacy of a Combination of Nitazoxanide and Hydroxychloroquine Versus Hydroxychloroquine Alone in COVID-19 Patients | A Randomized, Open Label, 2-Treatment Groups Clinical Trial Evaluating the Safety and Efficacy of a Combination of Nitazoxanide and Hydroxychloroquine Versus Hydroxychloroquine Alone in the Acute Treatment of Moderate COVID-19 Patients | | Dr Reddys Laboratories Limited | 12-06-2020 | 20200612 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44408 | Not Recruiting | No | | | | 15-06-2020 | 158 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Open Label | Phase 2 | India→ | D Mallikarjuna Rao→ | | Regulatory Affairs
Proprietary Products
Innovation Plaza, IPDO
Survery No.54, Bachupally Village, Bachupally Mandal → | mallikarjunard@drreddys.com→ | 914044346860→ | Dr Reddys Laboratories Limited→ | Inclusion criteria: 2. Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab <br/ ><br>Note: A re-treated/ relapsed patient may be enrolled if he/she meets all of the following criteria: <br/ ><br>a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARS-CoV-2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARS-CoV-2 after previous treatment <br/ ><br>AND <br/ ><br>b. Clinical symptoms associated with COVID-19 (fever, cough, fatigue, shortness of breath, expectoration, myalgia, rhinorrhea, sore throat, diarrhea, anosmia, ageusia) have either re-appeared after previous treatment OR continued to be present without improvement OR are aggravated <br/ ><br>AND <br/ ><br>c. Patient meet the below-mentioned criterion (# 3) for â??moderateâ?? COVID-19 disease severity <br/ ><br>3. Patients clinically assigned as â??moderateâ?? (Pneumonia with no signs of severe disease, respiratory rate â?¥24 breaths/minute, SpO2 <94% (90%-94%) on room air) <br/ ><br>Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV). <br/ ><br>4. Females should have a negative serum pregnancy test at baseline; female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment <br/ ><br>5. Able and willing to provide informed consent <br/ ><br>6. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ ><br>7. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment→ | Exclusion criteria: 1. Patients with hypersensitivity or a contra-indication to hydroxychloroquine or nitazoxanide <br/ ><br>2. Patients with history of or one or more known comorbidities at baseline: <br/ ><br>a. Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure <br/ ><br>b. Uncontrolled Diabetes Mellitus <br/ ><br>Note: Investigators may use clinical discretion to enrol well controlled diabetic patients who are either currently receiving or not currently receiving anti-diabetic medications. <br/ ><br>c. COPD, Asthma or Interstitial Lung Disease <br/ ><br>d. Malignancy <br/ ><br>e. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ ><br>f. G6PD deficiency <br/ ><br>g. Psoriasis or porphyria <br/ ><br>h. Kidney Disease (Serum creatinine > 1.5 times upper limit) <br/ ><br>i. Liver disease (e.g. Child Pugh score â?¥ B or AST (Aspartate Transaminase) >3.5 times upper limit) <br/ ><br>j. Cardiac conduction delay (QTc > 500 msec) <br/ ><br>k. Retinopathy or macular degeneration <br/ ><br>3. In case of patients with symptoms associated with COVID-19 at screening assessment (ie, one or more of fever, cough, sore throat, breathlessness, rapid respiratory rate, low oxygen saturation in blood, body ache, chills, chills with shaking, fatigue, headache, loss of smell, loss of taste, diarrhea, nasal congestion or any other symptom considered by the Investigator to be reasonably associated with COVID-19), the first onset of symptoms was > 10 days before screening (not applicable for re-treated/relapsed patients). <br/ ><br>4. Receiving or has received antiviral therapy (including oseltamivir, zanamivir, favipiravir, umifenovir, ribavirin, anti- retroviral therapy with lopinavir and ritonavir (LPR/r)), nitazoxanide or ivermectin within 28 days or chloroquine/hydroxychloroquine in the six months prior to baseline visit <br/ ><br>5. Received biological therapy (especially, experimental ACE-2 decoy or decoy receptor/monoclonal antibody against interleukin-6, interferon alpha) in the 90 days prior to baseline visit. <br/ ><br>6. Patients clinically assigned as having â??severeâ?? COVID-19 disease (Severe Pneumonia (with respiratory rate â?¥30/minute and/or SpO2 < 90% in room air) or Acute Respiratory Distress Syndrome or Septic shock), critically ill patients and those currently requiring or anticipated to imminently require one or more forms of extracorporeal life support (eg mechanical ventilation, extracorporeal membrane oxygenation) in the judgement of the Investigator (on basis of COVID-19 disease severity, rate of progression, co-morbidities or complications) at the time of Randomization <br/ ><br>Note: The severity is as defined by the Clinical Management Protocol: COVID-19 published by the Ministry of Health & Family Welfare on 03 Jul 2020 (Appendix IV). <br/ ><br>7. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients <br/ ><br>8. Inability to take oral medication. <br/ ><br>9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ ><br>10. Current smoker or has quit smoking within last 3 months <br/ ><br>11. Body Weight < 45 kg <br/ ><br>12. Female patients who are pregnant or lactating <br/ ><br>13. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg Methotrexate, Cyclosporine etc.) <br/ ><br>14. Patients who are contemplating sur→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Hydroxychloroquine: 600 mg QD (on Days 1 and 2) followed by 200 mg BID (on Days 3 to 14)<br>Intervention2: Nitazoxanide and Hydroxychloroquine: Nitazoxanide: 1000 mg QD (on Days 1 and 2) followed by 500 mg BID (on Days 3 to 14) + Hydroxychloroquine: 600 mg QD (on Days 1 and 2) followed by 200 mg BID (on Days 3 to 14)<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | Change from baseline in mean viral load (determined by rRT-PCR on a nasopharyngeal/ oropharyngeal swab)Timepoint: Day 14 or at discharge from hospital, whichever is earlier→ | | | | Yes | False | | |
| → | CTRI/2020/06/025852 | 27 January 2021 | RNB in UPUMS SAIFAI | STUDY TO EVALUATE EFFECT OF RNB (RAJ NIRVAN BATI) AYURVEDIC MEDICINE IN COVID-19 ILLNESS | | INTRA MURAL | 12-06-2020 | 20200612 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44204 | Not Recruiting | No | | | | 14-06-2020 | 20 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 1/ Phase 2 | India→ | Dr Raj Kumar→ | | Administrative block
up university of medical sciences saifai, etawah (UP) up university of medical sciences saifai, etawah (UP)→ | ramakant.gsvm@gmail.com→ | | Department of Neurosurgery→ | Inclusion criteria: 1.Ageâ?¥18years <br/ ><br> 2.Laboratory(RT-PCR)positiveofSARS- CoV-2 <br/ ><br>→ | Exclusion criteria: 1.Patient refuse for consent. <br/ ><br>2.Criticalyil patient (Sp02 <90%, Shock, Altered Sensorium). <br/ ><br>3.Patient with deranged renal function (S. creatinine >1.5mg/dl) <br/ ><br>4.Pregnancy&lactating. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: AYURVEDIC DRUG RNB: DAIL DOSE OF RNB(125mg)BD IS GIVEN TO COVID 19 POSITIVE PATIENTS WHO FULL FILL TH E INCLUSION AND EXCLUSION CRITERIA for 10 days<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | 1)Clinical improvement of symptoms which was their at the time of admission <br/ ><br>2)microbiological: microbiological clearance of virus by nasal swab and throat swab by RTPCRTimepoint: after 10 day of intervetion→ | | | | Yes | False | | |
| → | CTRI/2020/06/025853 | 27 January 2021 | Mental Health of children during Covid-19 Pandemic | Impact of Coronavirus pandemic on mental health of children | | ESIC PGIMSR | 12-06-2020 | 20200612 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44466 | Not Recruiting | No | | | | 17-06-2020 | 100 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Mahima Rajan→ | | Office of the Head of the Department, Dept of Pediatrics,ESIC PGIMSR, Basaidarapur, New Delhi → | rajanmahima@gmail.com→ | 07387109658→ | ESIC PGIMSR, Basaidarapur, New Delhi→ | Inclusion criteria: School going children aged 6-17 years of health care workers working in ESI PGIMSR and associated hospital, Basaidarpur and from general population→ | Exclusion criteria: Children with known psychiatric, neurological, developmental and other chronic illnesses will be excluded.→ | Health Condition 1: F439- Reaction to severe stress, unspecified
→ | | Prevalence of psychosocial problems among the Indian school going children during the pandemic covid-19Timepoint: 10 days→ | | | | Yes | False | | |
| → | CTRI/2020/06/025850 | 27 January 2021 | Studying tobacco use and quitting behaviour due to the coronavirus lockdown in India. | Assessing the tobacco consumption patterns and willingness to quit among tobacco users during COVID-19 lockdown in India. | | Dr Monika Arora | 12-06-2020 | 20200612 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44518 | Not Recruiting | No | | | | 20-06-2020 | 800 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Monika Arora→ | | 14 Anand Lok, 2nd Floor, August Kranti Marg, New Delhi 110049 → | monika@hriday-shan.org→ | 01141031191→ | HRIDAY→ | Inclusion criteria: The study will include consenting adults (20 years and above), both males and females, who consume tobacco in any form (smoked, smokeless or both) or who have quit tobacco in the past 3 months (around COVID-19 onset). The participants will be recruited from a pre-existing cohort of the CARRS study (â??Centre for cArdiometabolic Risk Reduction in South Asia â?? CARRSâ??) which is a model surveillance system for cardio-metabolic diseases led by the Centre for Chronic Disease Control. The CARRS cohort participants are community-based in Delhi and Chennai and recruited from households randomly selected using multi-stage cluster random sampling. <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>→ | Exclusion criteria: - Not consuming any tobacco or quit more than 3 months ago. <br/ ><br>- Not knowing one of the three languages: English or Hindi or Tamil. <br/ ><br>- Hospitalized or being critically ill.→ | | Intervention1: No intervention: Not applicable<br>Control Intervention1: No intervention: Not applicable<br>→ | 1) Tobacco Use (Prevalence, Type, Frequency) <br/ ><br>2) Tobacco Cessation BehaviourTimepoint: Baseline→ | | 31/08/2020 | | Yes | False | | |
| → | CTRI/2020/06/025844 | 27 January 2021 | Pre-Identified Homoeopathic Medicines In Asymptomatic Covid -19 Individuals Receiving Standard Treatment Protocol | Comparative Effectiveness Of Pre-Identified Homoeopathic Medicines In Asymptomatic Covid -19 Individuals Receiving Standard Treatment Protocolâ??An Open Label, Randomised, Placebo Controlled Trial | | Central Council for Research in Homoeopathy New Delhi | 12-06-2020 | 20200612 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43760 | Not Recruiting | No | | | | 22-06-2020 | 200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Anil Khurana→ | | Room no. 408
61-65 Institutional Area, Janakpuri → | varanasiroja@gmail.com→ | 9999454036→ | Central Council for Research in Homoeopathy→ | Inclusion criteria: COVID 19 confirmed individuals who are Asymptomatic and receiving standard treatment protocol <br/ ><br>Age 18 years & above and of both sexes <br/ ><br>Willing to sign written informed consent <br/ ><br>→ | Exclusion criteria: Pregnant women or lactating mothers <br/ ><br>Immunocompromised persons on basis of medical history <br/ ><br>Symptomatic COVID-19 individualsNot willing to give informed consent <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Homoeoapthic medicine: Arsenicum album 30- four pills twice daily for seven days, Bryonia 30- four pills twice daily for seven days, Camphora 1M- four pills twice daily for four days alongwith Standard treatment protocol<br>Control Intervention1: Placebo four pills twice daily for seven days: Placebo alongwith Standard treatment protocol<br>→ | An individual remaining asymptomatic/ becoming symptomatic / virologically negative during the maximum duration of incubation period (21 days)/ till the patient is at CCC as per the standard treatment protocol (ICMR)Timepoint: At 5th day, 10th day, 15th day→ | | | | Yes | False | | |
| → | CTRI/2020/06/025854 | 27 January 2021 | BCG vaccination against COVID-19 | Study to Evaluate the Effectiveness of BCG vaccine in Reducing Morbidity and Mortality in Elderly individuals in COVID-19 Hotspots in India - BCG for COVID-19 | | Indian Council of Medical Research | 13-06-2020 | 20200613 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44078 | Not Recruiting | No | | | | 25-06-2020 | 1450 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Srikanth Tripathy→ | | ICMR-National Institute for Research in Tuberculosis
No.1, Satyamoorthy Road
Chetput, Chennai → | pcorchids@gmail.com→ | 9498022949→ | ICMR-National Institute for Research in Tuberculosis→ | Inclusion criteria: 1)Elderly individuals 60 years â?? 95 years of age with general good health, as confirmed by history and physical examination. <br/ ><br> <br/ ><br>2) No known history of HIV or on immunosuppressive drugs for malignancy or transplant <br/ ><br> <br/ ><br>3) Provide a signed and dated informed consent form <br/ ><br> <br/ ><br>Elderly individuals with or without co-morbid conditions like Diabetes mellitus, or Hypertension or Hyperlipidemia will be considered for this study, if they are on regular treatment.→ | Exclusion criteria: 1) Positive for SARS-Cov2 infection, by either antibody (serology) or PCR test <br/ ><br>2) Known HIV or malignancy or Transplant recipient or on Dialysis <br/ ><br>3) Individuals on immune-suppressive therapies or treatments for malignancy or transplant / dialysis / anti-retroviral treatment <br/ ><br>4) Recently (in the last 6-months) diagnosed with TB or currently on anti-TB treatment or anti-psychiatric medications <br/ ><br>5) Has any BCG vaccine contraindication like allergy or hypersensitivity to BCG, individuals with HIV infection, leukaemia, malignant lymphoma, chronic granulomatous disease, <br/ ><br>6) H/o of previous administration of experimental MTB vaccines within the past 6 months. <br/ ><br>7) Sick and moribund individuals with Karnofsky score <50 <br/ ><br>→ | | Intervention1: BCG vaccine: Single dose of <br>0.1ml of BCG vaccine given intradermally <br>(BCG-Serum Institute of India) over the distal insertion of the deltoid muscle onto the left humerus (approximately one third down the left upper arm)<br>Frequency : Once<br>Duration of therpay: Once<br>Control Intervention1: None: No intervention<br>→ | Proportion of patients with Severe COVID disease based on COVID Severity Scale and proportion of death due to Covid 19 disease <br/ ><br>Timepoint: 6 months post vaccination→ | | | | Yes | False | | |
| → | CTRI/2020/06/025856 | 27 January 2021 | Evaluation of siddha regimen in the management of covid 19 | An open clincal evaluation of selected siddha regimen in expediting the management of covid 19 - A randomized controlled study | | Directorate of indian medicine and homeopathy | 13-06-2020 | 20200613 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44606 | Not Recruiting | No | | | | 25-06-2020 | 200 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable | Phase 2 | India→ | Dr S M Chitra→ | | Department of Maruthuvam No 6 Government siddha medical college
Anna arch road
Arumbakkam
Chennai → | nanbu.sumi@gmail.com→ | 9443279412→ | Government Siddha Medical College Chennai→ | Inclusion criteria: Confirmed RT-PCR test positive with mild and moderate symptom patients→ | Exclusion criteria: Age less than 18 and above 60 <br/ ><br>pregnancy and lactating mothers <br/ ><br>patients with severe or critical covid 19 infections <br/ ><br>mentally retarded and those who are taking pshychiatric drugs <br/ ><br>immuno compromised patients <br/ ><br>patients with co-morbid disease conditions <br/ ><br>other viral pneumonia <br/ ><br>patients who have received organ transplantation in the past 6 months or planning surgery <br/ ><br>patients participating in other covid 19 trials <br/ ><br> will be excluded clinically or based on available medicial reports→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 1.Kabasura kudineer<br>2.Vasantha kusumakaram Mathirai<br>3.Thippili Rasayanam <br>4.Adathodai Manapagu<br>: 1.Kabasura kudineer 60 ml bd, before food.<br>2.Vasantha kusumakaram Mathirai 1 tablet bd, after food.<br>3.Thippili Rasayanam 2gms bd, after food.<br>4.Adathodai Manapagu 15 ml bd with 30ml lukewarm water, after food for 14 days<br><br>Control Intervention1: 1.Hydroxychloroquine<br>2.Azithromycin<br>3.BCT<br>4.Omeprazole<br>5.Vitamin C<br>6.Zinc: 1.Hydroxychloroquine - 1st day 400mg bd, 2nd to 5th day 200mg bd<br>2.Azithromycin - 250mg bd for 5 days<br>3.BCT - 1 bd<br>4.Omeprazole- 20mg bd<br>5.Vitamin C - 1 bd<br>6.Zinc - 1 bd<br>→ | Primary Outcome would be measured through Resolution of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment at 4 weeks.Timepoint: Primary Outcome would be measured through Resolution of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment at 4 weeks.→ | | | | Yes | False | | |
| → | CTRI/2020/06/025855 | 27 January 2021 | Effect of AYUSH 64 in COVID 19 | Efficacy of Ayurveda Intervention (AYUSH 64) as add-on therapy in COVID 19 patients - An open label randomized controlled trial | | IPGT and RA | 13-06-2020 | 20200613 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44386 | Not Recruiting | No | | | | 15-06-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2 | India→ | Dr Sagar M Bhinde→ | | Room no 533 kaumarbhritya department IPGT and RA Gujarat Ayurved University Jamnagar → | kaurmandip22@yahoo.com→ | 9427572306→ | IPGTRA Jamnagar→ | Inclusion criteria: Asymptomatic or minimal symptomatic COVID 19 patients Patients having 0 to 4 score as per the WHO ordinal scale for clinical improvement <br/ ><br>Age 18 to 70years <br/ ><br>Patients who can take oral medicine <br/ ><br>Patients who are ready to give written consent <br/ ><br>→ | Exclusion criteria: Age below 18 and above 70years <br/ ><br>Patients having severe symptoms of COVID19 <br/ ><br>Patients on mechanical ventilator or organ support <br/ ><br>Patients do not able to take oral medication <br/ ><br>Pregnant and lactating women <br/ ><br>Oncological diseases and other systemic uncontrol conditions such as HTN diabetes etc <br/ ><br>Liver or kidney malfunctions. <br/ ><br>Severe pneumonia Acute respiratory distress syndrome Sepsis and Septic Shock <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: AYUSH 64: AYUSH 64 02 Capsules of 500mg each orally thrice daily for 14 days as add-on therapy to supportive and symptomatic allopathic treatment for COVID 19 patients<br>Control Intervention1: Control arm: Supportive or symptomatic allopathic treatment as per guideline of study site hospital for COVID 19 patients <br>→ | Ordinal scale for Clinical improvement as per WHO <br/ ><br>Duration on mechanical ventilator <br/ ><br>All cause mortality <br/ ><br>Timepoint: 0 7 14 and 28th day→ | | 13/08/2020 | | Yes | False | | |
| → | CTRI/2020/06/025858 | 27 January 2021 | Observational study on suspected COVID 19 patients admitted to ICU | Epidemiological study of patients admitted in intensive care unit with severe acute respiratory illness with possible diagnosis of COVID19 (EPIC19) - EPIC 19 | | Dr Amarja Ashok Havaldar | 13-06-2020 | 20200613 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44652 | Not Recruiting | No | | | | 22-06-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Amarja Ashok Havaldar→ | | Department of Critical Care medicine St Johns Hospital Bangalore
KARNATAKA Department of Critical Care medicine St Johns
Hospital Bangalore KARNATAKA
Bangalore
KARNATAKA
560034
India Hospital Bangalore KARNATAKA
Bangalore
KARNATAKA
560034
India→ | amarjahavaldar@rediffmail.com→ | 9036082112→ | St Johns Medical college→ | Inclusion criteria: patients with severe acute respiratory illness and with possible diagnosis of COVID, requiring intensive care will be included→ | Exclusion criteria: Patients with respiratory failure or pneumonia not explained by COVID will be excluded. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J189- Pneumonia, unspecified organism
→ | | To study the epidemiology and clinical characteristics of patients admitted with SARI possibly due to COVID19 and their outcome <br/ ><br> <br/ ><br>Timepoint: ICU mortality <br/ ><br>at 4 weeks <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/06/025857 | 27 January 2021 | Follow-up of COVID-19 Positive Patients | Prospective Cohort Follow-up of COVID-19 Positive Patients: Symptom Presentation, Severity Spectrum, Quality of Life and Rehabilitation Needs: A mixed-methods study | | Kazi Md Amran Hossain | 13-06-2020 | 20200613 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44663 | | No | | | | 23-06-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Bangladesh→ | Md. Obaidul Haque→ | | Department of Physiotherapy, Bangladesh Health Professions Institute, CRP, Savar, Dhaka → | amranphysio@gmail.com→ | 8801735661492→ | Bangladesh Health Professions Institute→ | Inclusion criteria: Persons who found COVID 19 positive in RT PCR Test→ | Exclusion criteria: Persons who are unwilling and have cognitive impairments→ | Health Condition 1: B342- Coronavirus infection, unspecified
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Socio-demographics, Symptom presentation, Co-morbidity, Quality of life, Physical Activity, Functional limitationsTimepoint: 30 days→ | | | | Yes | False | | |
| → | CTRI/2020/06/025861 | 27 January 2021 | Scientific evaluation of Immuno-modulatory effects of AYUSH INTERVENTIONS on normal healthy and high-risk individuals in context with COVID-19 pandemic: An open level study | Scientific evaluation of Immuno-modulatory effects of AYUSH INTERVENTIONS on normal healthy and high-risk individuals in context with COVID-19 pandemic: An open level, multi centric, non-randomized, comparative, interventional community based study | | Department of Ayush Uttarakhand | 14-06-2020 | 20200614 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44072 | Recruiting | No | | | | 20-06-2020 | 500 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | Dr Alok Kumar Shukla→ | | State Ayurvedic Hospital Mahuakheraganj Industrial Area Kashipur → | kkpandey.dr@gmail.com→ | 9634465557→ | Department of Ayurvedic and Unani Services Uttarakhand→ | Inclusion criteria: 1. Male or female > 18 and < 75 years of age (inclusive). <br/ ><br>2. The normal healthy individuals. <br/ ><br>3. High risk individuals. <br/ ><br>4. Immunosuppressant peoples and subjects with mild to moderate co-morbidities. <br/ ><br>5. Non-symptomatic subjects under Institutional and Home Quarantine. <br/ ><br>6. Symptomatic subjects under Institutional Quarantine. (Optional, subject to approval from concerned officials and departments) <br/ ><br>7. Confirmed COVID-19 cases under isolation and treatment (Optional, subject to approval from concerned officials and departments) <br/ ><br>8. Signed ICF <br/ ><br>→ | Exclusion criteria: 1. Subjects < 18 and > 75 years of age <br/ ><br>2. Uncontrolled systemic illness. <br/ ><br>3. Hypersensitivity to any component of Investigational Drug. <br/ ><br>4. Recent history of drug or alcohol abuse. <br/ ><br>5. Pregnant female. <br/ ><br>6. Pre-existing GI symptoms like nausea and vomiting. <br/ ><br>7. Patients not willing to sign ICF. <br/ ><br>8. Individuals with severe co-morbidities. <br/ ><br>→ | | Intervention1: AYUSH INTERVENSION - Treatment Protocol - I:: <br><br>Ayush Raksha Kwath 10 gms (A.P.I.)<br>Luke warm decoction of of kwath churna twice daily 30 minute before breakfast and dinner<br><br>Ashwagandha Vati: 500 mg (A.P.I.)<br>1 tablet administered twice 30 minute before breakfast and dinner with luke warm water<br><br>Sanshmani Vaati: 500 mg (S.Y.S.)<br>1 tablet administered twice 30 minute before breakfast and dinner with luke warm water<br>Intervention2: AYUSH INTERVENTION - Treatment Protocol - II:: Ashwagandha Churna (A.P.I.) + Madhyashti Churna (A.P.I.)<br>1 gram powder of each twice daily 30 minute before breakfast and dinner with luke warm water<br>Amritadi Guggul 500 mg (A.F.I.)<br>2 tablets administered twice 30 minute before breakfast and dinner with luke warm water<br>Intervention3: AYUSH INTERVENTION - Treatment Protocol - III:: <br>Pippali Churna (A.P.I.) + Madhyashti Churna (A.P.I.)<br>1 gram powder of each twice daily 30 minute before breakfast and dinner with luke warm water<br>Amritadi Guggul 500 mg (A.F.I.)<br>2 tablets administered twice 30 minute before breakfast and dinner with luke warm water<br>Intervention4: AYUSH INTERVENTION - Treatment Protocol - IV:: <br>Shunthi Churna (A.P.I.) + Madhyashti Churna (A.P.I.) + Pippalimool Churna (A.P.I.)<br>500 mg powder of each twice daily 30 minute before breakfast and dinner with luke warm water<br>Amritadi Guggul 500 mg (A.F.I.)<br>2 tablets administered twice 30 minute before breakfast and dinner with luke warm water<br>Intervention5: AYUSH INTERVENTION - Treatment Protocol - V:: <br>Ashwagandha Churna (A.P.I.) + Madhyashti Churna (A.P.I.) + Shunthi Churna (A.P.I.)<br>500 mg powder of each twice daily 30 minute before breakfast and dinner with luke warm water<br>Amritadi Guggul 500 mg (A.F.I.)<br>2 tablets administered twice 30 minute before breakfast and dinner with luke w→ | i. Clinical, psychological and Quality of life assessment <br/ ><br> <br/ ><br>ii. Comparative analysis of occurrence of COVID-19 in subjects taking Ayurvedic Interventions and those not taking Ayurvedic Intervention <br/ ><br> <br/ ><br>iii. Comparative analysis of occurrence of conclusive symptoms of COVID-19 (as per ordinal scale of clinical improvement published by WHO). <br/ ><br> <br/ ><br>iv. Comparative analysis of occurrence of conclusive symptoms of other than non-COVID-19Timepoint: From baseline assessment, 1 week, 2 week and 4 week→ | | | | Yes | False | | |
| → | CTRI/2020/06/025862 | 27 January 2021 | Low Dose Radiation Therapy for COVID-19 | Low Dose Radiation Therapy For Covid-19 Pneumonia: A Pilot Study - COVID-AIIMS | | Not yet applied for funding | 14-06-2020 | 20200614 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43858 | Recruiting | No | | | | 13-06-2020 | 10 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 1 | India→ | Daya Nand Sharma→ | | Department of Radiation Oncology, IRCH, Room No. 241, AIIMS, Delhi → | sharmadn@hotmail.com→ | 09868969899→ | AIIMS, New Delhi→ | Inclusion criteria: 1. Confirmed cases of Covid-19 (by RT-PCR). <br/ ><br>2. Age >18 years. <br/ ><br>3. Patients with National Early Warning Score (NEWS) score â?¥ 5. <br/ ><br>4. Consent <br/ ><br>→ | Exclusion criteria: 1. Patients on mechanical ventilatory support. <br/ ><br>2. Hemodynamically unstable patients <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Radiation Therapy: Low dose radiation therapy with a dose of 70 cGy in single fraction<br>Intervention2: Low dose radiation therapy: Low dose radiation therapy, dose 70 cGy in 1F<br>Control Intervention1: Nil: Nil<br>→ | Symptomatic improvement or deterioration by comparing baseline NEWS score with post LDRT NEWS score on day 3, day 7 and day 14.Timepoint: NEWS score on day 3, day 7 and day 14. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/06/025874 | 27 January 2021 | To observe the effect of Siddha formulation Kabasura kudineer in COVID 19 patients | A randomized open labeled clinical study to compare the effectiveness of Kabasura kudineer and Vitamin-C Zinc supplementation in the management of asymptomatic SARS-CoV-2 patients | | Dean Government Theni Medical College | 15-06-2020 | 20200615 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44684 | Not Recruiting | No | | | | 24-06-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Dr C Anbarasi→ | | Arignar Anna Hospital Campus
Arumbakkam
Chennai Arignar Anna Hospital Campus
Arumbakkam
Chennai→ | drsankararaj@gmail.com→ | 9965897075→ | Government Theni Medical College and Hospital→ | Inclusion criteria: 1.Laboratory confirmed COVID-19 without symptoms <br/ ><br>2.Consenting to participate in the study and sign the informed consent→ | Exclusion criteria: 1.Patient with co morbid conditions like DM, HT and BA. <br/ ><br>2.Patients with severe primary respiratory disease or other pathogenic microbial pneumonia that needs to be identified with COVID-19. <br/ ><br>3.Pregnant and mothers those who have a pregnancy plan. <br/ ><br>4.Patients with other systemic malignant diseases such as malignant tumors, mental illnesses, etc., which the researchers consider unsuitable for participation in the study. <br/ ><br>5.People who have been allergic to Siddha medicine or intolerant to taking medicine. <br/ ><br>6.Patients participating in other COVID-19 clinical trials. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Kabasura kudineer: Siddha medicine<br>30 â?? 60 ml twice daily orally<br>Control Intervention1: Zinc and Vitamin C: Zinc -100 mg, Vit C â?? 60000 IU twice daily orally<br>→ | 1.Reduction in incidence of clinical symptoms like fever, cough and breathlessness. <br/ ><br>2.Negative conversion of SARS-CoV-2 by 14 days <br/ ><br>3.Reduction in Viral load of SARS-CoV-2 at the end of treatment (0, 7, 14 days) <br/ ><br>4.Examine the levels of immune markers and inflammatory markers (IgG, IgM, IgA, Th1 (TNF-Alfa, IFN-gamma, IL2) Th2 (IL6, IL10) at the end of treatment (0, 7, 14 days) <br/ ><br>Timepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/06/025927 | 27 January 2021 | Comparison of C-MAC and Mc-GRATH laryngoscopes for intubation in COVID scenario. | Comparison of Mc Grath-MAC and C-MAC video laryngoscopes in novice users wearing face protective gear in the setting of COVID pandemic â?? a manikin based randomized crossover trial. | | All India Institute of Medical Sciences | 16-06-2020 | 20200616 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43316 | Not Recruiting | No | | | | 20-06-2020 | 30 | Interventional | Randomized, Crossover Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Saurabh vig→ | | Room no 10, first floor , Academic block, National Cancer institute, AIIMS, Jhajjar. Room no 10, first floor , Academic block, National Cancer institute, AIIMS, Jhajjar.→ | saurabh377@yahoo.com→ | 9538247725→ | National Cancer Institute, All India Institute of Medical Sciences.→ | Inclusion criteria: medical professionals (non anaesthetists) with no previous experience of intubation with video laryngoscopes.→ | Exclusion criteria: previous experience of intubating in similar setting (i.e. within intubation box with video laryngoscope)→ | | Intervention1: Intubation with video-laryngoscope: Intubation on a manikin with CMAC or McGrath MAC videolaryngoscope, with the intubating person wearing face protective PPE. Time to intubation defined as the time from passing the blade of largoscope between teeth of manikin to the visualization of first chest expansion. <br>Time to intubation noted by an independent observer. <br>intubating person to be randomly allotted one of the two laryngoscope to be used first and then use the second laryngoscope. time to intubation with both to be noted and compared.<br>Control Intervention1: Comparison between C-MAC and McGrath MAC laryngoscope, on a manikin with the intubating person wearing face protective PPE.: Time to intubation to be noted.<br>Defined as the time starting from passing the tip of the laryngoscope blade into the mouth of the manikin till observation of first chest expansion with the resuscitation bag)<br>Control Intervention2: Not applicable: Not applicable<br>→ | Time to intubation with each device. (Defined as the time starting from passing the tip of the laryngoscope blade into the mouth of the manikin till observation of first chest expansion with the resuscitation bag)Timepoint: Outcome noted at - Baseline.(i.e. at the time of intubation).→ | | | | Yes | False | | |
| → | CTRI/2020/06/025928 | 27 January 2021 | Local application of Povidone Iodine solution in nose and oral gargle for house hold contacts of COVID19 cases | Povidone Iodine Gargle and Intranasal application: A Quasi-Experimental study to reduce the spread of coronavirus infection in community with Covid-19 positive clusters. | | Dr Sumita Shankar | 16-06-2020 | 20200616 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44664 | Recruiting | No | | | | 30-06-2020 | 204 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Vivekanand Kattimani→ | | Sibar Institute of Dental Sciences, Guntur
Post- Takkellapdu
Mandalam- Pedakakani → | sum713@yahoo.com→ | 9848184495→ | Rangaraya Medical College→ | Inclusion criteria: 1- Household (HH) contacts of laboratory confirmed COVID-19 case(s) (more than or equal to one case per HH) <br/ ><br>2- Willing to carry out the procedures four times daily for 7 days if provided with the gargle solution. <br/ ><br>3- Resident in the area for the last six months. <br/ ><br>4- Persons willing to be part of this protocol and sign informed consent. <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1- Allergy (hypersensitivity) to povidone iodine. <br/ ><br>2- Currently have or have ever had a thyroid problem, including swelling. <br/ ><br>3- Pregnant women and lactating mothers. <br/ ><br>4- Persons who are unable to carry out the intervention due to intellectual disability. <br/ ><br>5- Persons who are too ill to participate.→ | | Intervention1: Povidone Iodine: 2% Povidone Iodine gargle<br>diluted to 1% (w/v) is used as<br>oropharyngeal gargle. <br><br>15 ml of diluted 1% (w/v) Povidone Iodine 4 times daily gargle at prescribed time and<br>intranasal application- 4 times daily using 1% (w/v) Povidone Iodine using applicator tip.<br>Control Intervention1: NIL: NIL<br>→ | The Decrease in the attack rate of Primary and Secondary contacts of COVID19 patients and reduction of the Viral Load (Using cycle threshold values of RT PCR at different timelines)Timepoint: 7th day→ | | | | Yes | False | | |
| → | CTRI/2020/06/025917 | 27 January 2021 | Psychological assessment of the health care-workers amid COVID-19 working at a tertiary care teaching hospital of the central India and impact of tele-counselling on their psychological problems | Psychological assessment of the health care-workers amid COVID-19 working at a tertiary care teaching hospital of the central India and impact of tele-counselling on their psychological problems - Telecounselling health care workers pandemic | | All India Institute of Medical Sciences Bhopal | 16-06-2020 | 20200616 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44505 | Not Recruiting | No | | | | 28-06-2020 | 25 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Shashank Purwar→ | | Department of Microbiology. All India Institute of Medical Sciences Bhopal → | profshashankpurwar@gmail.com→ | | All India Institute of Medical Sciences Bhopal→ | Inclusion criteria: 1. HCWs working actively in hospital irrespective of areas of work (COVID or non-COVID). <br/ ><br>2. HCWs in the quarantine who were otherwise involved in providing care at the aforementioned settings. <br/ ><br>3. Willing to provide written consent. <br/ ><br>PS- Inclusion Criteria for the interventional study: Only those participants would be enrolled for the study who would score higher than the cut-off on DASS-21 & IES-R and willing to provide the informed consent. <br/ ><br>→ | Exclusion criteria: 1. Those not worked actively in the institute since February 2020. <br/ ><br>2. A diagnosed case of any psychiatry illness. <br/ ><br>3. Suffering from any severe medical illness which would preclude their participation. <br/ ><br>4. Those falling in the severe range in DASS21 & IES-R requiring pharmacotherapy <br/ ><br> <br/ ><br>→ | | Intervention1: Tele-counselling: 1. Express empathy<br>2. Emphasize a strength <br>3. Psycho- Education<br>4. Relaxation Training<br>5. Life Skill Training <br>6. Problem solving training<br>Control Intervention1: Control arm: general health information and psychoeducation (nutrition advise, COVID-related information [preventive guidelines & factual information]), physical exercise)<br>→ | Change in scores DASS21 (Depression, Anxiety, Stress) and IES-R (Impact of Scale revised)Timepoint: 10 days, 24 days and 38 days after commencement of Tele-counselling, which is the intervention.→ | | | | Yes | False | | |
| → | CTRI/2020/06/025957 | 27 January 2021 | A Clinical Study on Favipiravir and Umifenovir Compared to Favipiravir alone in Hospitalized Patients with Moderate COVID-19. | A Randomized Open-Label Study To Evaluate The Efficacy And Safety Of Favipiravir And Umifenovir As Compared To Favipiravir Alone In Moderate Hospitalized Adult Indian COVID-19 Patients. | | Glenmark Pharmaceuticals Ltd | 17-06-2020 | 20200617 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44709 | Recruiting | No | | | | 29-06-2020 | 158 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3 | India→ | Amol Pendse→ | | Glenmark Research Centre, Plot No. A-607, T.T.C. Industrial Area,MIDC, Mahape, Navi Mumbai → | Pawan.Singh@glenmarkpharma.com→ | 02250451200→ | Glenmark Pharmaceuticals Ltd→ | Inclusion criteria: Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures <br/ ><br>2. Age > 18 years at the time of signing ICF <br/ ><br>3. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization) <br/ ><br>4. Radiographic evidence of pneumonia <br/ ><br>5. Respiratory rate > 24 breaths per minute <br/ ><br>6. Any two of the following signs or symptoms suggestive of COVID-19: cough/shortness of breath or difficulty in breathing/fever/chills/muscle pain/sore throat/new loss of taste or smell <br/ ><br>7. Oxygen saturation (SpO2) â?¤ 93 % on room air <br/ ><br>8. Time interval between symptoms onset and randomization less than 10 days <br/ ><br>9. Currently hospitalized and requiring medical care for COVID 19 <br/ ><br>10. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum pregnancy test <br/ ><br>11. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment; <br/ ><br>12. Not participating in any other interventional drug clinical studies before completion of the present study. <br/ ><br>→ | Exclusion criteria: Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely <br/ ><br>Severe infection, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ ><br>Severe respiratory distress and PaO2/FiO2 â?¤ 300 mmHg <br/ ><br>Inability to intake or tolerate oral medications. <br/ ><br>Liver disease or alanine aminotransferase (ALT) /aspartate aminotransferase (AST) elevated over 5 times the ULN <br/ ><br>Gout/history of gout or hyperuricemia (above the ULN) <br/ ><br>Prolonged QT, defined as QTcF â?¥450 milliseconds for men and as QTcF â?¥470 for women <br/ ><br>Known severely reduced LV function (ejection fraction <30%) <br/ ><br>Heart rate â?¥ 125 beats per minute <br/ ><br>Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure). <br/ ><br>Known allergy or hypersensitivity to favipiravir or umifenovir <br/ ><br>Subject is using adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers <br/ ><br>Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS-CoV-2 < 24 hours prior to study drug dosing <br/ ><br>Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis; <br/ ><br>Asthma or chronic obstructive lung disease <br/ ><br>Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year). <br/ ><br>Pregnant or lactating women; <br/ ><br>Having used favipiravir or umifenovir participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ ><br>Clinical prognostic non-survival or requirement of palliative care.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Favipiravir 200mg Tablets: Dosage Form: Tablets, <br>Dosage Frequency: 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days, <br>Mode of Administration: Oral<br>Intervention2: Umifenovir capsules: 800 mg BID: Dosage Form: Capsule<br>Dosage Frequency: 800 mg BID, <br>Mode of Administration: Oral<br>Control Intervention1: Favipiravir 200mg Tablets: Dosage Form: Tablets <br>Dosage Frequency: 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days, <br>Mode of Administration: Oral<br><br>→ | Time from randomization to clinical cure (defined as resolution of baseline clinical signs and symptoms of COVID-19 infection and at least 2 point improvement on WHO Ordinal Scale for Clinical Improvement) (Time frame-28 days).Timepoint: Upto 28 days→ | | | | Yes | False | | |
| → | CTRI/2020/06/025960 | 27 January 2021 | To study effect of Ivermectin drug in patients infected with SARS-CoV-2 virus. | "A Prospective, randomized, single centred, open labelled, two arm, placebo-controlled trial to evaluate efficacy and safety of Ivermectin drug in patients infected with SARS-CoV-2 virus." | | Dr Rajkumar Nikalje | 18-06-2020 | 20200618 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44373 | Not Recruiting | No | | | | 18-06-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Meenakshi Bhakare→ | | Department of Respiratory Medicine, 5th floor Symbiosis Medical college for women, Lavale Hill base, Gram-Lavale, Tal- Mulshi
Dist- Pune → | asstprof.respiratorymedicine1@smcw.siu.edu.in→ | 9028560535→ | Symbiosis Medical College for Women and symbiosis university hospital and research centre→ | Inclusion criteria: Symptomatic patients infected with SARS-CoV-2 virus diagnosed on Real time PCR test, admitted to hospital.→ | Exclusion criteria: 1. Age less than 18 and more 70 years <br/ ><br>2. Pregnant and lactating women <br/ ><br>3. Patients not willing to give written informed consent <br/ ><br>4. Seriously ill patients requiring intensive care <br/ ><br>5. Known hypersensitivity to Ivermectin drug 6. Subjects who have participated in another investigational drug or research study within 30 days of screening. <br/ ><br>7. Subjects who are using any medication or has any disease which in the judgment of the Investigator will interfere with the conduct or interpretation of the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tablet Ivermectin: Dose: 12 mg <br>Route: per orally <br>Frequency:once a day<br>Duration: for 3 days.<br>Control Intervention1: Standard of care: standard of care<br>→ | Effect of Ivermectin on eradication of virus by testing for SARS-Co-V-2 by Real time PCR testTimepoint: day 7→ | | | | Yes | False | | |
| → | CTRI/2020/06/025977 | 27 January 2021 | Clinical Study to Study Safety and Efficacy of herbal formulation - Aayudh Advance | A Randomized and Comparative Study to assess Safety and Efficacy of Supplemental Treatment of a herbal formulation - Aayudh Advance comprising essential oils in patients with Corona Virus 2019 (Covid-19) | | Ms Shukla Ashar Impex Pvt Ltd | 18-06-2020 | 20200618 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44449 | Not Recruiting | No | | | | 22-06-2020 | 120 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label | Phase 2 | India→ | Dr Manish Rachchh→ | | Opp. Zydus Pharmez,Matoda Patiya, Ahmedabad → | vd.ganatra@gmail.com→ | | Ganatra Ayurveda & Panchkarma Clinic→ | Inclusion criteria: Subject willing to sign informed consent. <br/ ><br>Subject age group of 18 years and above of both gender. <br/ ><br>All patients with COVID-19 PCR positive (within 7 days/high clinical suspicion admitted to Corona Virus study participating hospital will be eligible. <br/ ><br>Patients who are having mild to moderate symptoms of Covid-19 disease and tested positive for Covid-19 test.→ | Exclusion criteria: Patients younger than 18 years. <br/ ><br>Women who are pregnant or who intend to become pregnant for the next three months after taking the drug. <br/ ><br>Patients allergic to type medications or any of the ingredient of the formulation. <br/ ><br>Patients with a neurological history (seizures, epilepsy, etc.). <br/ ><br>Patients with a previous history of psychiatric illnesses (depression, anxiety, suicide attempt). <br/ ><br>Patients with cardiac pathologies or relevant chronic diseases that in the judgment of the clinician recommend the non-inclusion of the patient in the study. <br/ ><br>Patients who would require artificial ventilation or oxygen supply. <br/ ><br>Very severe patients of Covid 19. <br/ ><br>Patients with severe hypertension, diabetes shall be excluded. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Aayudh Advance: 15 ml three times a day before meal for 21 days until the covid-19 negative<br>Control Intervention1: Standard of care treatment: As per the Standard of care treatment provided<br>→ | To compare the safety and efficacy of the Supplemental herbal formulation - Aayudh Advance with Standard treatment. <br/ ><br>Establish if the preventive administration of herbal formulation - Aayudh Advance attenuates the clinical manifestations of COVID-19 in people who become infected. <br/ ><br>Timepoint: every visit→ | | 28/11/2020 | | Yes | False | | |
| → | CTRI/2020/06/025996 | 27 January 2021 | A study to evaluate the effect of a combination Giloy Gomutra Capsules, Asthi Churna and Kamdhenu Asava in COVID-19 | A Clinical Evaluation of the combination Giloy Gaumutra Capsules, Asthi Churna and Kamdhenu Asava in the Management of the Pandemic- Covid-19. | | Bansi Gir Gaushala | 19-06-2020 | 20200619 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44622 | Not Recruiting | No | | | | 27-06-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | N/A | India→ | Dr Dineshchandra Pandya→ | | B-19 First Floor, District shopping centre,Sector 21 → | urvipandya18@gmail.com→ | 09638300839→ | Neuropanch Ayurveda Hospital and Research Organization→ | Inclusion criteria: Age: >18 years <60 years. <br/ ><br>Patient having Covid-19 positive and with signs and symptoms of Covid-19. <br/ ><br>→ | Exclusion criteria: Age: <16 years and > 60 years. <br/ ><br>Pregnant women and lactating mother <br/ ><br>Severe cases of Covid-19 like associated Pneumonia, COPD, and other severe associated diseases. <br/ ><br>Patient on ventilator. <br/ ><br>Uncontrolled Diabetes Mellitus & Hypertension <br/ ><br>Any other serious systemic illness like AIDS, Malignancy etc. <br/ ><br>Patients who are not willing to be included in the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: A Clinical Study on the efficacy of the combination Giloy Gaumutra Capsules, Asthi Churna and Kamdhenu Aasava in the Management of the Pandemic- Covid-19- An Open labeled Randomized Clinical Trial: All the three drugs will be given to one group of patients along with allopathic treatment, it will be experimental group. Another group will be given only allopathic treatment. This will be controlled group. Ayurvedic treatment will be given for 15 days.Giloy Gaumutra Capsules 4 tds. Asthi Churna 5 gm with Hot water for twotimes, Kamdhenu Asava 15 ml for two times with hot water For 15 days by Oral route.<br>Control Intervention1: Clinical Study on the efficacy of the combination Giloy Gaumutra Capsules, Asthi Churna and Kamdhenu Aasava in the Management of the Pandemic- Covid-19- An Open labeled Randomized Clinical Trial: All the three drugs will be given to one group of patients along with allopathic treatment, it will be experimental group. Another group will be given only allopathic treatment. This will be controlled group. Ayurvedic treatment will be given for 15 days.Giloy Gaumutra Capsules 4 tds. Asthi Churna 5 gm with Hot water for twotimes, Kamdhenu Asava 15 ml for two times with hot waterwith 15 days via oral route<br>→ | Symptoms of the Covid-19 patients will be evaluated for its recovery in each follow-up. Results will be seen as add-on treatment after comparing both the groups.Timepoint: On 7th and 15th days of the treatment→ | | | | Yes | False | | |
| → | CTRI/2020/06/025998 | 27 January 2021 | Efficacy of An Ayurvedic Preparation Raj Nirwan Bati (RNB) on symptomatic COVID-19 Patients | To Determine the Efficacy of An Ayurvedic Preparation Raj Nirwan Bati (RNB) on symptomatic COVID-19 Patients: A Double-Blind Randomized Controlled Trial - RNB | | Uttar Pradesh University of Medical Sciences | 20-06-2020 | 20200620 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44707 | Not Recruiting | No | | | | 30-06-2020 | 60 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Case Record Numbers Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Dr Raj Kumar→ | | Uttar Pradesh University of Medical Sciences, Saifai, Etawah → | nareshpalsingh@gmail.com→ | 09458641119→ | Uttar Pradesh University of Medical Sciences→ | Inclusion criteria: 1. RT-PCR confirmed SARS-CoV-2 infected symptomatic patients admitted to the COVID-19 hospital of UPUMS <br/ ><br>2. Patients falling in mild, moderate and severe category of COVID-19 illness <br/ ><br>3. Patients more than 18 years of age <br/ ><br>→ | Exclusion criteria: 1. All critically ill patients of COVID-19 <br/ ><br>2. Patients not providing informed written consent for the study <br/ ><br>3. Pregnant and lactating females <br/ ><br>4. Patients of Chronic kidney disease (CKD) more than stage three <br/ ><br>5. Asymptomatic cases <br/ ><br>6. Study participants becoming critically ill during the course of intervention. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Raj Nirwan Bati capsule: 1. Mercury (Para)<br>2. Sulphur (Gandhak)<br>3. Gold (Sona)<br>4. Silver (Chandi)<br>5. Clamina Perpeta<br>6. Arsenic Trioxide (Hartal Bhasma)<br>7. Black pepper (Kaali Mirch)<br>8. Naag Damanti (Snake Plant)<br>9. Celery (Azwaiyan)<br>10. Zinc<br>11. Niramish (Mahamash oil)<br><br>One Raj Nirwan Bati capsule of 125 mg (1 Ratti) twice a day empty stomach for 12 days<br>Control Intervention1: Placebo: Sugar gelatin capsule<br>with 4 small balls of sugar <br>twice a day empty stomach for 12 days<br>→ | Micro-biologically becoming RT-PCR negative for SARS-CoV-2Timepoint: Micro-biologically RT-PCR results for SARS-CoV-2 shall be evaluated at baseline, day 6 and day 12→ | | | | Yes | False | | |
| → | CTRI/2020/06/026000 | 27 January 2021 | COVID-19 in kidney transplant recipient | Clinical Profile, management and outcomes of COVID-19 in kidney transplant recipients | | Seth GS Medical College and KEM Hospital | 21-06-2020 | 20200621 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44567 | Recruiting | No | | | | 26-06-2020 | 75 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Divya Bajpai→ | | Department of Nephrology
Seth GS Medical College and KEM Hospital. Ward 34A, old hospital building, 3rd floor, Acharya Donde Marg, Parel, Mumbai → | tukaramjamale@yahoo.co.in→ | 9167460362→ | Seth GS Medical College and KEM Hospital→ | Inclusion criteria: 1. Kidney transplant recipients admitted to KEMH with diagnosis of COVID-19 by <br/ ><br>investigation (Positive swab test for COVID-19) <br/ ><br>2. Age >18yrs <br/ ><br>3. Both genders are to be included→ | Exclusion criteria: 1. Patients with incomplete medical records→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Outcome of kidney transplant recipients with Covid-19 infectionTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/06/026001 | 27 January 2021 | Ivermectin in COVID | Randomised Controlled Trial of Ivermectin in hospitalised patients with COVID19 - RIVET-COV | | AIIMS New Delhi | 21-06-2020 | 20200621 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44196 | Recruiting | No | | | | 25-06-2020 | 120 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 2/ Phase 3 | India→ | Anant Mohan→ | | Third Floor,Porta Cabin, Department of Pulmonary, Critical Care And Sleep Medicine, AIIMS New Delhi → | anantmohan@yahoo.com→ | | AIIMS New Delhi→ | Inclusion criteria: diagnosed COVID19 patients admitted to AIIMS COVID facility <br/ ><br>Age > 18 years <br/ ><br>Informed consent <br/ ><br>Non-severe disease: Non-severe disease (Asymptomatic/ Mild <br/ ><br>disease OR moderate): SpO2â?¥90% on room <br/ ><br>air with presence of clinical features of <br/ ><br>dyspnea and/or hypoxia, fever, cough and/or <br/ ><br>Respiratory Rate more or equal to 24 per <br/ ><br>minute→ | Exclusion criteria: Not giving written informed consent <br/ ><br>ALT/AST >5 times the upper limit of normal. <br/ ><br>Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30). <br/ ><br>Pregnant or breast feeding. <br/ ><br>Allergy to any study medication. <br/ ><br>Severe co-morbidity as per investigatorâ??s assessment <br/ ><br>Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment. <br/ ><br>Prolonged QT interval ( >450 ms) <br/ ><br>Any other concomitant therapeutic trial <br/ ><br>Weight <15 kg <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Intervention Arm 1: 12 mg (200 microgram/kg) <br>Formulation: elixir<br>Route of administration: oral<br>Frequency: Only single dose<br>Intervention2: Intervention Arm 2: 24 mg (400 microgram/kg) <br>Formulation: elixir<br>Route of administration: oral<br>Frequency: Only single dose<br>Intervention3: Intervention Arm 3: 48 mg (800 microgram/kg) <br>Formulation: elixir<br>Route of administration: oral<br>Frequency: Only single dose<br>Intervention4: Intervention Arm 4<br>: 96 mg (1600 microgram/kg)<br> Formulation: elixir<br>Route of administration: oral<br>Frequency: Only single dose<br>Intervention5: Intervention Arm 5<br>: 120 mg (2000 microgram/kg) <br>Formulation: elixir<br>Route of administration: oral<br>Frequency: Only single dose<br>Control Intervention1: Placebo: placebo<br>Formulation: Elixir of similar taste and consistency<br>Frequency: only single dose<br><br>alongwith<br>Standard medical care as per treating physician and institution<br>→ | Two co-primary outcomes <br/ ><br>1. Frequency of RTPCR negativity at day 5 after drug administration <br/ ><br>2. Change in viral load (as determined by RTPCR cycle threshold) at day 5 as compared to baselineTimepoint: Day 5 after drug administration→ | | | | Yes | False | | |
| → | CTRI/2020/06/025999 | 27 January 2021 | Clinical trial of ShatPlus as an immunomodulator in adult Covid 19 positive patients | Phase II, open label, randomized controlled trial to evaluate safety and efficacy of ShatPlus as an immunomodulator in adult Covid 19 positive patients | | BVG Life Sciences Ltd | 21-06-2020 | 20200621 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44764 | Not Recruiting | No | | | | 27-06-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 2 | India→ | Dr Pawan Kumar Singh→ | | Sagar Complex, Opposite Kasarwadi Railway Station, Near
Nashikphata, Old Pune-Mumbai Road,Chinchwad, Pune - 411034 → | pawan.singh@bvglife.com→ | 9409616256→ | BVG Life Sciences Ltd. (BVG Group)→ | Inclusion criteria: Patients admitted with RT-PCR confirmed COVID-19 illness. <br/ ><br>Mild to Moderately Covid 19 disease (NEWS score less than or equal to 8) <br/ ><br>Signed informed consent must be obtained and documented according to AYUSH GCP, and national/local regulations. <br/ ><br>→ | Exclusion criteria: Pregnant women <br/ ><br>Breastfeeding women <br/ ><br>Requiring ICU admission at screening <br/ ><br>Patients above 65 years of age and below 18 Years <br/ ><br>Past History of MI, Epileptic episodes <br/ ><br>Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at screening <br/ ><br>Any other condition by which subject proves unfit from investigator perspective <br/ ><br>Not giving consent. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ShatPlus along with standard<br>treatment: 10 ml thrice a day per oral ShatPlus along with standard treatment<br>Control Intervention1: Standard treatment: Standard treatment as per<br>protocol of ICMR<br>→ | No. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19 <br/ ><br>Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/ face on 5 point ordinal scale <br/ ><br>Serum levels of CD4, CD8, NK cell panel CD16/CD56, CRP, IgM, IgG <br/ ><br>Clinical status expressed in percentage of subjects reporting each severity rating on a 6-point ordinal scale <br/ ><br>Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 end of study→ | | | | Yes | False | | |
| → | CTRI/2020/06/026005 | 27 January 2021 | Pooled testing for COVID | Validation of SARS CoV-2 RT-PCR testing using
combinatorial tapestry pooling of samples: a multi-centre study | | National Centre for Biological Sciences | 21-06-2020 | 20200621 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44520 | Not Recruiting | No | | | | 22-06-2020 | 321 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Omshree Shetty→ | | Department of Pathology
7th Floor, Annexe Building
Tata Memorial Hospital
Ernest Borges Road, Parel
→ | omshreens@gmail.com→ | | Tata Memorial Centre→ | Inclusion criteria: samples of nasopharyngeal swabs submitted for COVID testing to each of the participating centres as per current testing guidelines→ | Exclusion criteria: nil→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: nil: This is a diagnostic validation study, using previously collected samples, which will be carried out<br>independently, in parallel at each of the participating centres. Samples will be subjected to individual testing will be performed as per the COVID-19 testing workflow<br>by CSIR-CCMB following ICMR guidelines.In addition, samples will be subjected to pooled sampling - simple pooling and combinatorial tapestry pooling based on a computerised sensing algorithm.<br>Control Intervention1: nil: The results of individual testing will be taken as the gold standard. We will compare the results of the pooled sampling against this<br>→ | The primary outcome is the sensitivity and specificity of combinatorial tapestry <br/ ><br>pooling technique as compared to individual testing, across various prevalence rates and degrees of pooling.Timepoint: baseline→ | | | | Yes | False | | |
| → | CTRI/2020/06/026002 | 27 January 2021 | Study of use of Ayurveda Intervention (Ayush-64) in COVID 19 | Evaluation of Efficacy and Safety of Ayurveda Intervention (Ayush-64) add-on therapy for patients with COVID-19 infection (Stage I)-An Open labelled, Parallel Group, Randomized controlled clinical trial
| | National Institute of Ayurveda | 21-06-2020 | 20200621 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44799 | Not Recruiting | No | | | | 01-07-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 2 | India→ | Prof Pawan kumar Godatwar→ | | Room no. 127
PG Dept. of Roga & Vikriti Vijnana, National Institute of Ayurveda, Jaipur
Telephone Nos Off : 0141-2635753 ext-266 Fax : 0141- 2635709
→ | dr.jaykaran78@gmail.com→ | 9825219196→ | All India Institute of Medical Sciences, Jodhpur→ | Inclusion criteria: 1. Patients of 18-60 yrs of age, clinically diagnosed with corona virus disease 2019 by RTPCR test coming under stage I- mild (Early infection) <br/ ><br>2. Participants who can take medicines orally. <br/ ><br>3. Patients willing to provide signed informed consent. <br/ ><br>→ | Exclusion criteria: 1. Pregnant, Lactating women, patients with CKD (Chronic Kidney Disease). <br/ ><br>2. Not willing to participate in the study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: AYUSH 64: 2 Capsules/Tablets (500mg each) thrice daily by oral route for one month<br><br><br><br>Control Intervention1: Standard treatments as per guidelines: NA<br>→ | Clinical cure rate: Time to negative conversion of COVID19.Timepoint: Time to event→ | | | | Yes | False | | |
| → | CTRI/2020/06/026039 | 27 January 2021 | CANCER care in COVID-19 ERAâ?? A survey proposed to study the treatment preference and perspectives of patients with blood cancer in a highly specialized cancer care hospital in India during COVID-19 ERA. | CANCER care in COVID-19 ERAâ?? A prospective survey to study the preferences and perspectives of patients with hematological malignancies in a tertiary cancer care setting in India. (CANCOV SURVEY) - CanCov Survey Study | | NIL | 22-06-2020 | 20200622 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43815 | Not Recruiting | No | | | | 15-06-2020 | 213 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Avinash Bonda→ | | 81, Ground Floor, Main building , Tata Memorial Hospital, Dr E. Borges Road, Parel, Mumbai. → | avinash.bvn@gmail.com→ | 7506150611→ | Tata Memorial Center→ | Inclusion criteria: 1. Patients under evaluation for a suspected hematological malignancy or with a diagnosis of hematological malignancy (acute and chronic leukemias, lymphomas, myeloma, and others) will be included in the study. <br/ ><br>2. Patients who are planned for or receiving chemotherapy / immunotherapy / targeted therapy in the OPD, ward, daycare and ICU will be eligible.→ | Exclusion criteria: None→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C81-C96- Malignant neoplasms of lymphoid, hematopoietic and related tissue
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Proportion of patients who plan to continue on full intensity therapy- This will be the percentage of patients who are willing to go ahead with the full intensity therapy in the current scenario.Timepoint: 6 months or till the end of pandemic→ | | | | Yes | False | | |
| → | CTRI/2020/06/026044 | 27 January 2021 | Oral Fluid Sars-CoV-2 Ab Rapid test | Rapid point-of-care oral fluid screening test for Sars-CoV-2 antibodies to monitor COVID-19 disease - O-CovAb | | Asian Healthcare Foundation | 22-06-2020 | 20200622 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44919 | Not Recruiting | No | | | | 04-07-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Vishnupriya Rao Paturi→ | | DiabetOmics
6-3-349/31 Dwarakapuri,
Panjagutta
→ | aigres.mit@gmail.com→ | 9247164730→ | Asian Institute of Gastroenterology→ | Inclusion criteria: 1. 18 years or older, men and women <br/ ><br>2. Subjects suspected or with symptoms of Sars-CoV-2 <br/ ><br>3. Subjects, 3 days after the onset of symptoms <br/ ><br>4. Smoking or non-smoking <br/ ><br>5. Subjects willing for participating in the study and providing informed consent→ | Exclusion criteria: Subjects on ventilators or lung support→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | There is a significant positive correlation between presence or absence of (blood and salivary) antibodies (against Sars-CoV-19 virus) and, severity and duration of disease after onset of symptoms.Timepoint: 4 July - 19 August 2020→ | | | | Yes | False | | |
| → | CTRI/2020/06/026045 | 27 January 2021 | A study to improve the resistance against Covid 19 illness with the help of Homoeopathic remedies. | Evaluating the immune boosting ability of a homoeopathic therapeutic strategy involving a nosode Tuberculinum 1M, followed by Zincum Metallicum 6C, Chininum Arsenicosum 6C and Calc Phos 6x in asymptomatic novel corona virus disease (Covid-19 illness) vulnerable risk group. - Nil | | Father Muller Homoeopathic Medical College | 22-06-2020 | 20200622 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44677 | Not Recruiting | No | | | | 01-07-2020 | 800 | Interventional | Other<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr M K Kamath→ | | Department of Practice of Medicine
Father Muller Homoeopathic Medical College
University Road
Deralakatte
Mangalore → | dr.dilip.dixit@gmail.com→ | 9757247179→ | Father Muller Homoeopathic Medical College, Mangalore→ | Inclusion criteria: 1. All existing co-morbidities. <br/ ><br>2. High risk front line workers <br/ ><br>→ | Exclusion criteria: 1.Those with end stage renal disease and progressive liver dysfunctions <br/ ><br>2.Pregnant and lactating females <br/ ><br>3.Anyone who has taken HCQS and / or Homoeopathic prophylaxis Ars alb 30 / any other similar medicines for boosting the immunity against Covid-19 illness <br/ ><br>→ | | Intervention1: Homoeopathic Medicines a therapeutic strategy consisting of Tuberculinum 1M followed by Zincum Metallicum 6C Chininum Arsenicosum 6C and Calc Phos 6x plus health monitoring: Known Homoeopathic Pharmacopial preparations<br><br>These subjects will be observed for a total of 2 months (60 days), and data is collected against predetermined criteria every 15 days to determine how their exposure status to Covid-19 changes the outcome<br>Control Intervention1: Matching Control Arm Health monitoring: No intervention <br>These subjects will be observed for a total of 2 months (60 days), and data is collected against predetermined criteria every 15 days to determine how their exposure status to Covid-19 changes the outcome<br>→ | There will be a difference in the incidence rate of Covid-19 between control and intervention group. <br/ ><br>Incidence rate will be assessed with the help of RT PCR Covid-19 test. Patients in both the groups will be monitored for development of symptoms related to Covid-19. <br/ ><br>Timepoint: Subjects from both group will undergo evaluation on day 0, Day 15, day 30, day 45 and day 60 on predetermined parameters. <br/ ><br>Over and above these time points the patient will be provided with a help line and a physician for reporting symptoms on any given date.→ | | | | Yes | False | | |
| → | CTRI/2020/06/026055 | 27 January 2021 | An interventional study to access the effect of Ayurvedic medicine ASA-20 as a prohylaxis in high risk population exposed to COVID-19 | A prospective interventional study on the effect of ASA-20(Ayush kwath, Samsamani vati, Anu taila) as a prophylaxis measure among High risk population exposed to COVID-19 - ASA-20 | | Ministry of AYUSH | 23-06-2020 | 20200623 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44306 | Not Recruiting | No | | | | 26-06-2020 | 5000 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Sikha Lekharu→ | | department of Samhita Siddhant
room no 18
College of Ayurveda North Eastern Institute of Ayurveda and Homoeopathy
Mawdiangdiang
Shillong→ | shikhalekharu@gmail.com→ | 8811834122→ | North Eastern Institute of ayurveda and homoeopathy→ | Inclusion criteria: 1 Subjects of high risk population <br/ ><br>2 Male or female subjects above the age of 15 years to 70 years. <br/ ><br>3 Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study. <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1 Pregnant and Lactating woman <br/ ><br>2 Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening. <br/ ><br>3 Subjects who are on any regular medication(alternative/modern) for any other ailments. <br/ ><br> <br/ ><br>4 Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>5 Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrollment or could interfere with his participation in, and completion of the protocol. <br/ ><br>→ | | Intervention1: ASA-20: Ayush kwath- 3gm twice daily after food<br>Samsamani Vati- 500 mg twice daily after food <br>Anu taila- 2 drops twice daily in each nostril<br>The total duration of Ayurveda intervention will be for 30 days.<br><br>Control Intervention1: Non-treatment Control: In the non-treatment control group no medicine/placebo will be administered. Standard guidelines for COVID-19 prevention will be followed.<br>→ | To assess the occurrence of COVID-19 infection in healthy volunteers exposed to COVID-19 in the communityTimepoint: 6 MONTHS→ | | | | Yes | False | | |
| → | CTRI/2020/06/026056 | 27 January 2021 | An interventional study to access the effect of Homoeopathic medicine Arsenicum album 30 C as a prohylaxis in high risk population exposed to COVID-19. | A prospective interventional study on the effect of Arsenicum album 30 C as a prophylactic measure among High risk population exposed to COVID-19. - ARCOV | | Ministry of AYUSH | 23-06-2020 | 20200623 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44130 | Not Recruiting | No | | | | 26-06-2020 | 5000 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Tapan Nath→ | | Department of Case Taking and
Repertory
College of Homoeopathy
Room no 24 NEIAH
Mawdiangdiang near police outpost→ | tapanbngn@gmail.com→ | 8837349308→ | North Eastern Institute of Ayurveda and Homoeopathy (NEIAH)→ | Inclusion criteria: 1. Subjects of high risk population. <br/ ><br>2. Male or female subjects above the age of 03 years to 65 years. <br/ ><br>3. Subject who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study.→ | Exclusion criteria: 1. Pregnant and Lactating woman. <br/ ><br>2. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening. <br/ ><br>3. Subjects who are on any other regular medication( Alternative/ Modern)for any other ailments. <br/ ><br>4. Subjects participating in any other clinical study or having participated in any other study one month prior to screening in the present study. <br/ ><br>5. Subjects having a past history of allergy to any medicine that is part of the Homoeopathic <br/ ><br>intervention. Other conditions, which in the opinion of the investigators, makes the patient <br/ ><br>unsuitable for enrolment or could interfere with his participation in, and completion of the protocol.→ | | Intervention1: Arsenicum album 30 C: Arsenicum album 30 C<br>Once Daily for 3 consecutive days early morning in empty stomach.<br>One adult dose is 5 globules of no. 30 medicated globule<br>One child dose is 3 globules of no. 30 medicated globule<br>Control Intervention1: Placebo: Number 30 sugar gloubles will be used as placebo in the control arm<br>→ | To assess of occurrence of COVID-19 infection in healthy volunteers exposed to COVID-19 in the communityTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/06/026047 | 27 January 2021 | Dental education and coronavirus | Dental education and service practices in context of Coronavirus(COVID-19) pandemic : a qualitative study in West Bengal | | Swet Nisha | 23-06-2020 | 20200623 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44913 | Not Recruiting | No | | | | 01-07-2020 | 25 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Arnab Ganguly→ | | all india institute of hygiene public health block JC 27 AND 27b sector III bidhannagar→ | drarnabgangulymd@gmail.com→ | 9051721216→ | All India Institute Of Hygeine And Public Health→ | Inclusion criteria: Dental Graduates <br/ ><br>Dental Postgraduates <br/ ><br>Interns→ | Exclusion criteria: Others→ | | Control Intervention1: NIL: NIL<br>→ | Qualitative data generated by In-depth interviewing and Free listing and Pile sortingTimepoint: Baseline data collection to 4 weeks for data analysis→ | | | | Yes | False | | |
| → | CTRI/2020/06/026087 | 27 January 2021 | Phase II, randomized, controlled, open-label study of
Pegylated IFN alfa-2b with SARS-CoV-2 | A phase II, randomized, controlled, open-label study to
evaluate the efficacy and safety of Pegylated IFN alfa-2b in
the treatment of adult patients diagnosed with SARS-CoV2
(COVID-19). | | Cadila Healthcare Limited Zydus Research Center | 23-06-2020 | 20200623 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43775 | Not Recruiting | No | | | | 08-07-2020 | 40 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2 | India→ | Dr Kevinkumar Kansagra→ | | Zydus Research Center,Survey No. 396/403, Sarkhej-Bavla National Highway No.8A,Moraiya → | kevinkumarkansagra@zyduscadila.com→ | 91271766535→ | Cadila Healthcare Limited→ | Inclusion criteria: 1. Ability to comprehend and willingness to sign a written ICF for the study. <br/ ><br>2. Male or non-pregnant females, â?¥18 years of age at the time of enrolment. <br/ ><br>3. Understands and agrees to comply with planned study procedures. <br/ ><br>4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol. <br/ ><br>5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other <br/ ><br>commercial or public health assay in any specimen <br/ ><br>6.Women of childbearing potential must agree to use at least one primary form of <br/ ><br>contraception for the duration of the study (acceptable methods will be determined <br/ ><br>by the site).→ | Exclusion criteria: 1. Pregnant or breast feeding. <br/ ><br>2. Allergy to any study medication. <br/ ><br>3. Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigatorâ??s assessment. <br/ ><br>4. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Pegylated alpha 2b and Standard of care: Administer Day 1 and Day 8<br>Route-Subcutaneous<br><br>Control Intervention1: NIL: NIL<br>→ | Evaluation of the clinical efficacy of Pegylated IFN-α2b on the basis of change in ordinal <br/ ><br>scale.Timepoint: week 2 and week 4→ | | 04/09/2020 | | Yes | False | | |
| → | CTRI/2020/06/026118 | 27 January 2021 | Antiphospholipid Antibody (APLA) level in COVID-19 Cases.
| Evaluation of Antiphospholipid Antibody (APA) in COVID-19 Cases.
| | DR Rajlaxmi Sarangi | 24-06-2020 | 20200624 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44829 | Not Recruiting | No | | | | 01-08-2020 | 80 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | DrRajlaxmi Sarangi→ | | Dept. of Biochemistry
Kalinga Institute of Medical Sciences(KIMS), KIIT University,Patia, Bhubaneswar KIMS, KIIT University, Patia, Bhubaneswar, 751024→ | drrajlaxmisarangi@gmail.com→ | 8940222185→ | Kaling Institute of Medical Sciences, BBSR→ | Inclusion criteria: Cases: All RT-PCR positive COVID 19 cases admitted to KIMS COVID hospital. <br/ ><br>Control: Age and Gender matched apparently healthy Individuals <br/ ><br>→ | Exclusion criteria: â?¢RT-PCR positive COVID 19 cases but donot have Recent Surgery <br/ ><br>â?¢ Pregnancy <br/ ><br>â?¢ Hypertension, CAD, CKD, CLD, Malignancies <br/ ><br>â?¢ Obesity, smoking <br/ ><br>â?¢ Associated systemic autoimmune diseases <br/ ><br>â?¢ Estrogen intake <br/ ><br>â?¢ Chronic steroid therapy <br/ ><br>â?¢ Use of anticoagulant medications , vitamin K antagonists. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | This study will suggest if thrombosis is the major pathology causing seriousness of the disease.Timepoint: This study will suggest if thrombosis is the major pathology causing seriousness of the disease.→ | | | | Yes | False | | |
| → | CTRI/2020/06/026123 | 27 January 2021 | Plasma therapy in corona patients(Severe COVID-19). | A phase II, Open label, randomized controlled trial to assess the safety and efficacy of convalescent plasma in severe COVID-19. - PLATINA TRIAL. | | Dr Sushant Meshram | 24-06-2020 | 20200624 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44667 | Not Recruiting | No | | | | 25-06-2020 | 472 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Dr Sushant Meshram→ | | Dept of Pulmonary medicine, 4th floor, Super Specialty Hospital, Government Medical College Hospital, Nagpur. → | drsushant.in@gmail.com→ | 9860990379→ | government medical college and hospital Nagpur→ | Inclusion criteria: Hospitalized COVID-19 patients, Fever Cough breathlessness plus one or more of the following respiratory rate more than 30 per minutes, O2 saturation less than 90%, PaO2 by FiO2 less than 300. Patients with Comorbidities Viz.DM,COPD,HTN,Asthma included.→ | Exclusion criteria: Pregnant and Breast Feeding Females, Critically ill patients viz. Severe ARDS,Sepsis,Septic shock MODS,Coronary artery disease,arrhythmia Heart Failure.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | Intervention1: Convalescent plasma: Anti SARS COV 2 convalescent plasma viral neutralizing antibodies blood product two doses of 200 ml transfusion 24 hours apart<br>Control Intervention1: Standard of Care: Standard of Care as per guidelines of Directorate Medical Education,Govt of Maharashtra,which includes antibiotics,steroid,LMWH,HCQ,Oxygen Support.<br>→ | Proportion of patients showing at least 2 points clinical improvement on WHO ordinal scale at 28 days post randomization. <br/ ><br>All cause mortality at 28 daysTimepoint: 28 days→ | | | | Yes | False | | |
| → | CTRI/2020/06/026120 | 27 January 2021 | Validation of Rapid Test kit for Antibody (IgG, IgM) detection against COVID19. | Validation study of Rapid Test kit of Wrig Nano Systems for Antibody (IgG, IgM)
detection against COVID19. | | Maulana Azad Medical College | 24-06-2020 | 20200624 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44931 | Not Recruiting | No | | | | 03-07-2020 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Urmila Jhamb→ | | Maulana Azad Medical College and associated hospitals
Bahadur Shah Zafar Marg, New Delhi. → | ujhamb@hotmail.com→ | 9968604309→ | Maulana Azad Medical College→ | Inclusion criteria: Children and their parents/accompanying caretakers (i.e. patients of all age groups) admitted to department of pediatrics with suspected COVID 19 infection and volunteer staff members from department of pediatrics whose RTPCR on both Nasopharyngeal and oropharyngeal swab is <br/ ><br>reported as positive or negative.→ | Exclusion criteria: Whose RTPCR on both Nasopharyngeal and oropharyngeal swab is reported as rejected or poor quality.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Rapid antibody tests (Ig G and IgM) for COVID-19: Patients whose RTPCR on both Nasopharyngeal and oropharyngeal swab is reported positive will be screened for antibodies (IgG and IgM) by rapid antibody test kit.<br>Control Intervention1: Rapid antibody tests (Ig G and IgM) for COVID-19: Patients whose RTPCR on both Nasopharyngeal and oropharyngeal swab is reported negative twice ( To be sure that they are negative for COVID-19 infection) will be screened for antibodies (IgG and IgM) by rapid antibody test kit.<br>→ | Sensitivity and specificity of Rapid Test Kits against detection of COVID19 <br/ ><br>AntibodiesTimepoint: RTPCR for coronavirus will be tested at admission, while antibody test will be done 7-10 days of admission.After completing 50 cases,data analysis will be done.→ | | | | Yes | False | | |
| → | CTRI/2020/06/026119 | 27 January 2021 | Efficacy of Arsenic Album 30C and 200C potency in mild case of COVID-19 positive . (Isolation ward of Sir T General Hospital, Bhavnagar) patients: A randomized controlled study. | Efficacy of Arsenic Album 30C and 200C potency in mild case of COVID-19 positive patients: A randomized controlled study | | Swami Vivekaanand Homoeopathic Medical College And Hospital | 24-06-2020 | 20200624 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44218 | Not Recruiting | No | | | | 30-06-2020 | 90 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable | N/A | India→ | DrPranav Shah→ | | a 1 antarix,flat
ghogha circle
bhagnagar Dr.Hahnemann Road
near sport Colmplex
sidsar road
→ | shah_pranav1682@yahoo.co.in→ | 09714534973→ | swami Vivekanand Homoeopathic Medical College And Hospital→ | Inclusion criteria: 1. Male or females aged â?¥ 18 years with mild COVID-19 disease based on positive RT- PCR test. <br/ ><br>2. Voluntary willingness of patient to give written informed consent prior to participation in trial. <br/ ><br>→ | Exclusion criteria: 1. Hypersensitivity to study drug. <br/ ><br>2. Participating in any other trial <br/ ><br>3. Already taking drugs from alternative system. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ARSENIC ALBUM 30 add on to standard care: 1. Administration Of Medicine :- Oral Route<br>2. Form Of Dose:- 04 Globules (Medicated Globules ) <br>3. Repetition: - according to severity of symptoms Or according to posology<br><br>Intervention2: ARSENIC ALBUM 200 add on to standard care: 1. Administration Of Medicine :- Oral Rout<br>2. Form Of Dose:- 04 Globules (Medicated Globules ) <br>3. Repetition: - according to severity of symptoms Or according to posology<br><br>Control Intervention1: standard care alone: standard care to be given as per applicable guideline<br>→ | Proportion of clinically and virologically cured.Timepoint: Day 5,10 and 14→ | | | | Yes | False | | |
| → | CTRI/2020/06/026121 | 27 January 2021 | To Understand Knowledge and Compliance of Hydroxychloroquine Prophylaxis among Health Care Workers during COVID-19 pandemic | Knowledge and Compliance of Hydroxychloroquine Prophylaxis among Health Care Workers during COVID-19 pandemic: A Tertiary Care Centre based Survey | | SGPGIMS | 24-06-2020 | 20200624 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45006 | Recruiting | No | | | | 04-07-2020 | 175 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Mohan Gurjar→ | | Department of Critical Care Medicine, SGPGIMS, Lucknow (UP) 226014 India → | m.gurjar@rediffmail.com→ | | Sanjay Gandhi Postgraduate Institute of Medical Sciences (SGPGIMS)→ | Inclusion criteria: All health care workers who took Hydroxychloroquine prophylaxis during current COVID-19 Pandemic→ | Exclusion criteria: 1. HCQ prophylaxis not received; <br/ ><br>2. Unwillingness to participate in the survey; <br/ ><br>3. Unable to read and/or understand either English or Hindi language→ | | | Knowledge and compliance of HCQ prophylaxis by Health Care WorkersTimepoint: After complete duration of HCQ chemoprophylaxis (i. e. after 7 weeks)→ | | | | Yes | False | | |
| → | CTRI/2020/06/026147 | 27 January 2021 | Ayurveda and Yoga trial for preventing COVID 19 among quarantined individuals exposed to COVID 19 patients | Evaluation of the Prophylactic effect of Comprehensive Ayurveda and Mindfulness-based Yoga regimen among Quarantined individuals exposed to COVID 19 patients: A Randomized Controlled Trial | | infrastructural facility of All India Institute of Medical Sciences New Delhi | 25-06-2020 | 20200625 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43778 | Not Recruiting | No | | | | 10-06-2020 | 604 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Gautam Sharma→ | | 7th floor, Center for Integrative medicine and Research,Convergence block, All India Institute of Medical Sciences, New
Delhi → | cimraiimsdelhi@gmail.com→ | 01126549325→ | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: a) Quarantine individuals with a history of close contact or exposure to COVID 19 patients in the same household. <br/ ><br>b) Males and females of 18 years and older, in ambulatory condition (not bedridden) <br/ ><br>c) Not previously diagnosed with COVID-19 <br/ ><br>d) Absence of symptoms of COVID 19 such as fever, cough, sore throat, breathlessness, Acute respiratory infection etc. <br/ ><br>e) Willingness and ability to comply with trial and follow-up procedures. <br/ ><br>f) Ability to understand the nature of the trial and give written informed consent. <br/ ><br>→ | Exclusion criteria: a) Suspected or confirmed current COVID-19 case as diagnosed by treating physician <br/ ><br>b) Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. <br/ ><br>c) Pregnant at the time of screening or lactating women <br/ ><br>d) History of taking immunosuppressant drugs <br/ ><br>e) Any other condition which the investigators feels, may interfere with the study outcomes <br/ ><br>→ | | Intervention1: comprehensive Ayurveda and yoga regimen: The participants in the intervention group will receive comprehensive Ayurveda and yoga regimen/therapy which will be administered for the first 6 weeks following recruitment into the trial. <br>Ayurveda medicines<br>a.Tab Samshamani Vati 250 mg<br>b.Nishamalaki Churna 1-3 gm <br><br>2) Yoga Therapy: <br>The yoga practices will be taught by the institutionally qualified yoga therapists. There will be 5 online initial sessions which will be taught in the first week following recruitment and weekly once in the following weeks. A total of 10 online sessions will be conducted. The patients will be advised to practice yoga everyday (at least 5 days a week) for 6 weeks.<br>Video of the complete session and picture based modules will be given, which will be free from the influence of education. A log book will be given to all recruited participants to follow their practice at home including duration and time of practice, additional physical activities, and intake of medications.<br><br>In Group 1, the both the drugs will be administered from date of randomization until the clinical event or study completion at 6 weeks. Medicines should be taken and Yoga practice should be done at approximately the same time each day.<br><br>Control Intervention1: standard prophylactic measures: standard prophylactic measure prescribed by All India institute of medical Sciences, New Delhi<br>→ | Incidence of confirmed COVID-19 positive cases detection in experimental arm compared to control <br/ ><br> Outcome would be reported as the percent of participants in each arm who have a confirmed SARS-CoV-2 infection during study treatment. <br/ ><br>Timepoint: Baseline, end of 6th week→ | | | | Yes | False | | |
| → | CTRI/2020/06/026151 | 27 January 2021 | Ayurveda and Yoga trial for preventing COVID 19 among healthcare workers |
Evaluation of the prophylactic effect of Comprehensive Ayurveda and Mindfulness-based Yoga regimen among health care workers (HCW) of a tertiary care hospital in Delhi during COVID 19 Pandemic: a randomized controlled trial
| | infrastructural facility of All India Institute of Medical Sciences New Delhi | 25-06-2020 | 20200625 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43770 | Not Recruiting | No | | | | 10-06-2020 | 452 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 2 | India→ | Dr Gautam Sharma→ | | Center for Integrative medicine and Research, 7th floor, Convergence block, All India Institute of Medical Sciences, New Delhi → | cimraiimsdelhi@gmail.com→ | 01126549325→ | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: a. Aged 18-60 years <br/ ><br>b. Both genders <br/ ><br>c. AIIMS employee from any department(OPD/IPD) with risk of exposure to COVID-19 cases <br/ ><br>d. No history of symptoms attributable to COVID-19 or any acute respiratory illness <br/ ><br>e. Willingness and ability to comply with trial and follow-up procedures. <br/ ><br>f. Ability to understand the nature of the trial and give written/e-consent informed consent <br/ ><br>→ | Exclusion criteria: a. Suspected or confirmed current COVID-19, as determined by treating physician <br/ ><br>b. Pregnant or Nursing women <br/ ><br>c. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. <br/ ><br>d. Any other condition which the investigators feels, may interfere with the study outcomes <br/ ><br>→ | | Intervention1: comprehensive Ayurveda and Mindfulness based Yoga module: The participants in the intervention group will receive comprehensive Ayurveda and yoga regimen/therapy which will be administered for 12 weeks following recruitment into the trial.<br>(1)Ayurveda Intervention includes:<br>a. Tab Samshamani Vati 250 mg 2 tablet BD <br>b. Tab Kalamegha tablet 250 mg BD <br><br>(2) Yoga Therapy: <br>The yoga practices will be taught by the institutionally qualified yoga therapists. There will be 5 online initial sessions which will be taught in the first week following recruitment and weekly once in the following weeks. A total of 16 online sessions will be conducted. The patients will be advised to practice yoga everyday (at least 5 days a week) for 12 weeks.<br>Video of the complete session and picture based modules will be given, which will be free from the influence of education. A log book will be given to all recruited participants to follow their practice at home including duration and time of practice, additional physical activities, and intake of medications.<br><br>Control Intervention1: standard Prophylactic measures: Standard prophylactic mneasures prescribed by All India Institute of Medical Sciences, New Delhi<br>→ | Incidence of confirmed COVID-19 positive cases detection in experimental arm compared to controlTimepoint: Baseline, 8th week, 12th Week→ | | | | Yes | False | | |
| → | CTRI/2020/06/026161 | 27 January 2021 | Drug Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation II [Sanshamani Vati Plus] as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients | A Randomized, Open Label, Parallel Efficacy, Active Control, Multi-Centre Exploratory Drug Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation II [Sanshamani Vati Plus] as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients | | AYUSHCSIR | 26-06-2020 | 20200626 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44832 | Not Recruiting | No | | | | 21-09-2020 | 140 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Case Record Numbers Blinding and masking:Investigator Blinded | N/A | India→ | Mr Chandu Devanpally→ | | Office: 318, Next to Frankfin, Level-3, Connaught Place, Bund Garden Road, Pune-411001, MH, India.→ | dmmondhe@iiim.ac.in→ | | Indian Institute of Integrative Medicine (Council of Scientific & Industrial Research)→ | Inclusion criteria: i) Typical clinical presentation of acute onset febrile illness with cough and a RT_PCR based laboratory confirmation test for COVID-19. The patients may have other symptoms such as fever (patients with episodes of fever up to 48 hrs. and constant fever reading will be considered), myalgia, headache, diarrhoea and tastelessness suggestive of COVID-19. <br/ ><br>ii. Patients with mild to â??moderate diseasePatients must agree not to share medication <br/ ><br>iii. Patients willing to participate and sign an informed consent→ | Exclusion criteria: i. Patients suffering from severe COVID-19 Disease as judged by a physician <br/ ><br>ii. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study <br/ ><br>iii. History of immunosuppression: solid organ or bone marrow transplant, use of immunosuppressive antimetabolic and biologic agents, intrinsic immunodeficiencies, HIV infection. <br/ ><br>iv. Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. <br/ ><br>v. Atleast one fever episode every 24 hours for > 72h <br/ ><br>vi. Patients on parenteral nutrition <br/ ><br>vii. Patients with known sensitivity or contraindication to any of the ingredients of study medication <br/ ><br>viii. History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.) <br/ ><br>ix. Patients who are likely to worsen or planned ICU admission or ventilator support due to any reason <br/ ><br>x. Pregnancy and lactation <br/ ><br>xi. Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19 <br/ ><br>xii. Participation in any other clinical trial of an experimental agent treatment for COVID-19 <br/ ><br>xiii. Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind. <br/ ><br>xiv. Physician decision that involvement in the study is not in the patient´s best interest→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Formulation 2 And SOC: Guduchi+Pippali [T. Cordifolia + Piper longum] Administered along with standard of care<br>2 tablets bid (twice daily) with warm water for 12 weeks.<br>Control Intervention1: Standard of Care: As per Hospital SOP<br>→ | a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery (see criteria below)] <br/ ><br>b) Proportion of patients showing clinical recoveryTimepoint: Time Frame: From baseline up to 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/06/026152 | 27 January 2021 | COVID-19 in dialysis patients | A study on outcome of COVID-19 infection in Haemodialysis patients | | Seth GS Medical College and KEM Hospital | 26-06-2020 | 20200626 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43879 | Not Recruiting | No | | | | 26-06-2020 | 120 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Sayali Thakare→ | | Department of Nephrology,
Ward 34A,Old Hospital Building
Seth G.S.Medical College and KEM Hospital, Acharya Donde Marg, Parel, Mumbai-12 → | tukaramjamale@yahoo.co.in→ | 9167460362→ | Seth G.S.Medical College and KEM Hospital→ | Inclusion criteria: 1. Patients with ESRD on Maintenance Haemo-dialysis admitted to KEM Hospital with the diagnosis of COVID-19 by CDC criteria <br/ ><br>2. All age groups and both genders are to be included→ | Exclusion criteria: 1. Patients with incomplete medical records→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | Outcome of haemodialysis patients with covid 19 infectionTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/06/026181 | 27 January 2021 | Herbal Steaminhaler clinical trial on COVID patients | A Prospective, Open Label, multi Center clinical Study to evaluate the Safety, Efficacy And Tolerability Of AZADVIR (Herbal Steaminhaler) In Asymptomatic, Mildly Symptomatic COVID -19 Patients And Health Care Workers Posted To Covid Wards | | HAOMA WELLNESS CENTER | 26-06-2020 | 20200626 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44976 | Not Recruiting | No | | | | 04-07-2020 | 40 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | Kavya Kannoth Shaji→ | | HAOMA WELLNESS CENTER
No 404 3RD A MAIN ROAD HRBR LAYOUT 3RD BLOCK BANGALORE → | drshajikannoth@gmail.com→ | 8048664855→ | HAOMA WELLNESS CENTER→ | Inclusion criteria: 1. Male or non-pregnant female adult with or without comorbidities between the agre group of 18-85 years of age at time of enrollment <br/ ><br>2. Has laboratory-confirmed positive COVID-19 infection as determined by RT-PCR or other commercial or public health assay in any specimen, an RT-PCR (Nasopharynx, Throat, and Blood) test shall be repeated to assess eligibility <br/ ><br>3. Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures <br/ ><br>4. Health care workers who visited to COVID patients <br/ ><br>→ | Exclusion criteria: 1. Testing positive for HIV, HbsAg, HCV infection, VDRL. <br/ ><br>2. Females who are currently pregnant or breastfeeding. <br/ ><br>3. Allergy or other contraindication to one of the investigational products. <br/ ><br>4. Has received Eflornithine within the last 10 days. <br/ ><br>5. Has received anti-viral, anti-malarial or anti-bacterial within the last 14 days. <br/ ><br>6. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN). <br/ ><br>7. QTc interval â?¥ 500ms. <br/ ><br>8. Recent Myocardial Infarction (within last 6 months). <br/ ><br>9. Known case of (K/C/O) Congestive heart failure. <br/ ><br>10. K/C/O Chronic Kidney Disease. <br/ ><br>11. K/C/O active Tuberculosis. <br/ ><br>12. History of drug or alcohol dependence in the past 6 months. <br/ ><br>13. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ ><br>14. Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ ><br>15. K/C/O of epilepsy or CNS disorders. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | Intervention1: AZADVIR Drops : Herbal steam inhaler: Two drops in steam inhaler<br>Twice daily <br>Morning and Evening <br>Duration : Day 0 to Day 7<br>Control Intervention1: NIL: NIL<br>→ | To evaluate the efficacy AZADVIR (Herbal steamInhaler) supplement in COVID-19 patients <br/ ><br> <br/ ><br>Expecting 5 to 7 days RT PCR COVID negative testTimepoint: Day 0 to Day 10→ | | | | Yes | False | | |
| → | CTRI/2020/06/026190 | 27 January 2021 | A Trial of Shirashadi Kasai in patients with Covid-19 | A Trial of Shirashadi Kasai in Adults Hospitalized with Moderate to Severe Covid-19 | | Prof Jaya Chakravarty | 26-06-2020 | 20200626 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45005 | Not Recruiting | No | | | | 14-07-2020 | 160 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Abhishek Pandey→ | | Department of Medicine, Institute of Medical Sciences, Banaras Hindu University, Varanasi-221005 → | abhishek.pandey1@bhu.ac.in→ | 7081598111→ | Institute of Medical Sciences, Banaras Hindu University→ | Inclusion criteria: 1. Subject (or legally authorized representative) provides written informed consent prior to <br/ ><br>initiation of any study procedures. <br/ ><br>2. Understands and agrees to comply with planned study procedures. <br/ ><br>3. Agrees to the collection of OP swabs and venous blood per protocol. <br/ ><br>4. Male or non-pregnant female adult â?¥18 years of age at time of enrolment. <br/ ><br>5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other <br/ ><br>commercial or public health assay in any specimen < 72 hours prior to randomization. <br/ ><br>6. Illness of any duration, and at least one of the following: <br/ ><br>Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR <br/ ><br>Clinical assessment (evidence of rales/crackles on exam) AND SpO2 â?¤ 94%on room air, OR <br/ ><br> Requiring mechanical ventilation and/or supplemental oxygen. <br/ ><br>7. Women of childbearing potential must agree to use at least one primary form of <br/ ><br>contraception for the duration of the study (acceptable methods will be determined by the <br/ ><br>site).→ | Exclusion criteria: 1. ALT/AST > 5 times the upper limit of normal. <br/ ><br>2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) <br/ ><br>3. Pregnancy or breast feeding. <br/ ><br>4. Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ ><br>5. Allergy to any study medication→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Shirashadi Kasai: Shirashadi Kasai (SK). It consists of 5 medicinal plants, namely Albizzia lebbeck, Solanum Xanthocarpum,<br>Adhatodavasica, Glycyrrhiza glabra and Cinnamum tamal. <br>10 gm decoction, twice a day, through oral route<br>Control Intervention1: Standard care for COVID 19 patients as per Government of India advisory: Drugs advised by Government of India in its advisory for COVID 19 patients<br>→ | In this study, Primary outcome will be the time to clinical improvement,defined as the time from randomization to either an improvement of two points on a seven category ordinal scale or discharge from the hospital, whichever came first.Timepoint: Daily until discharge→ | | | | Yes | False | | |
| → | CTRI/2020/06/026188 | 27 January 2021 | Psychological Assessment of adult COVID-19 patients | Assessment of psychological health of patients diagnosed with COVID-19 | | KIMS KIIT University | 26-06-2020 | 20200626 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45024 | Not Recruiting | No | | | | 06-07-2020 | 240 | Observational | Other<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Alternation Blinding and masking:Open Label | N/A | India→ | Dr Jayaprakash Russell Ravan→ | | Department of Psychiatry
Kalinga Institute of Medical Sciences
Basement of Hospital building Room no 003
KIIT university Bhubaneswar Odisha → | jayaprakashrussell.ravan@kims.ac.in→ | 8763213999→ | Kalinga Institute of Medical sciences, KIIT University→ | Inclusion criteria: Those willing to give consent→ | Exclusion criteria: Children <br/ ><br>Those under ventilatory support <br/ ><br>Those not willing to give consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Assessment of psychological health : prevalence of depression, anxiety and PTSD symptoms in COVID 19 adult patients in Odisha COVID hospitalTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/06/026187 | 27 January 2021 | Clinical trial of herbal supplement as an immunomodulator in adult Covid 19 positive patients. | Phase II, open label, randomized controlled trial to evaluate Safety and Efficacy of ACT12 Tablet and ACT 13 dry syrup as an immunomodulator in adult Covid 19 positive patients - Nil | | Mr Ghanshyam Goti | 26-06-2020 | 20200626 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45027 | Not Recruiting | No | | | | 05-07-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 2 | India→ | Dr Pawan Kumar Singh→ | | Sagar Complex, Old Pune-Mumbai Road,Chinchwad. → | gplifehealthcare@gmail.com→ | 9824917109→ | Gplife Healthcare Pvt Ltd→ | Inclusion criteria: Patients admitted with RT-PCR confirmed COVID-19 illness. <br/ ><br>Age > 18 & < 65 years of either sex <br/ ><br>Mild to Moderately Covid 19 disease (NEWS score â?¤ 8) <br/ ><br>Signed informed consent must be obtained and documented according to AYUSH GCP, and national/local regulations. <br/ ><br>→ | Exclusion criteria: Pregnant women <br/ ><br>Breastfeeding women <br/ ><br>Requiring ICU admission at the screening <br/ ><br>Patients above 65 years of age and below 18 Years <br/ ><br>Past History of MI, Epileptic episodes <br/ ><br>Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at the screening <br/ ><br>Any other condition by which subject proves unfit from investigator perspective <br/ ><br>Not giving consent. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ACT12 tablets and ACT 13 dry Syrup along with standard treatment: 2 tablets of ACT12 and 20 ml ACT 13 dry syrup TDS along with standard of care for 10 days<br>Control Intervention1: Standard treatment: Standard treatment as per<br>protocol of ICMR for 10 days<br>→ | No. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19 <br/ ><br>Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/ face on 5 point ordinal scale <br/ ><br>Serum levels of CRP, IgM, IgG <br/ ><br>Clinical status expressed in percentage of subjects reporting each severity rating on a 6-point ordinal scale.Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 ie end of study→ | | | | Yes | False | | |
| → | CTRI/2020/06/026189 | 27 January 2021 | To Compare the safety and efficacy of Vitamin D, with Magnesium in mild to moderate Covid 19 patients | Randomized, Double Blind, Parallel Group Study of Vitamin D3 & Magnesium in Covid 19 Infection - Covid | | Suraksha Pharma Private Limited | 26-06-2020 | 20200626 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45029 | Not Recruiting | No | | | | 01-08-2020 | 210 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | AVN Sridhar→ | | 8-3-898/5,
suraksha towers,
Ameerpet,
→ | svp@surakshapharma.com→ | | suraksha pharma→ | Inclusion criteria: 1. Patients of either sex, 20 to 60 years of age with mild â?? moderate COVID -19 infection , found positive for COVID -19 test by RT_PCR are requiring Clinical management <br/ ><br> ( symptomatic patients who present with cough, fever, nasal congestion, gastrointestinal symptoms, fatigue, insomnia, ageusia or alternative signs of respiratory infections.) <br/ ><br>2. Participants who are willing to provide inform consent and willing to come for schedule follow up visit. <br/ ><br>3. Participants who are having normal hematological renal hepatic Parameters <br/ ><br>4. Participant not having contra indication to take standard treatment Vitamin D, magnesium <br/ ><br>5. Participants tested positive for COVID 19 by nose throat swab using PCR technique <br/ ><br>6. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study. <br/ ><br>→ | Exclusion criteria: 1. Patient having severe COVID -19 infection <br/ ><br>2. Patients presenting severe respiratory and/or multi systemic symptoms compatible with advanced COVID-19 and inter current acute or severe chronic diseases (i.e. active cancer). <br/ ><br>3. Participants with hypersensitivity or intolerance or contraindication to the use of standard treatment <br/ ><br>4. Participants with known allergy or contraindication to Vitamin D, Magnesium <br/ ><br>5. History of having received any investigational drug in the preceding one month. <br/ ><br>6. History of taking any kind of formulation or any other form of therapy for COVID 19 prophylaxis . <br/ ><br>7. Unwilling to come for regular follow-up for the entire duration of the study. <br/ ><br>8. COVID -19 RT-PCR Negative <br/ ><br>9. Any condition that, in the opinion of the investigator, does not justify the subjectâ??s inclusion in the study. <br/ ><br>10. Participants participating in other clinical study. <br/ ><br>11. Participant receiving other immune enhancers. <br/ ><br>12. Refusal to sign informed consent form <br/ ><br>13. Symptomatic for sever COVID-19 infection needing ICU <br/ ><br>14. Atherosclerotic Coronary Artery Disease <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Cholecalciferol vitamin D 3 <br>Magnesium Glycinate <br>: Vitamin D 60000 IU Single Dose + Magnesium Glycinate 250mg BD for 14 days<br><br>→ | Negative RT- PCR test for COVID 19 infection <br/ ><br>2 Improvement in Signs and symptoms of COVID 19 infection, use of ventilator, length of stay in ICU <br/ ><br>3 Reduction in CRP levels <br/ ><br>4 Reduction in rate of COVID -19 complication . <br/ ><br>5 Speed of recovery and duration to becoming asymptomatic <br/ ><br> 6 Length of hospital stay <br/ ><br>Timepoint: COVID 19 RT-PCR Test in 2 weeks <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/06/026184 | 27 January 2021 | Mental Health of Health Care Workers during COVID-19 pandemics | Assessment of Psychological health among health care workers during COVID-19 epidemics | | KIMS KIIT University | 26-06-2020 | 20200626 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45031 | Not Recruiting | No | | | | 06-07-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | DR RAMA CHANDRA DAS→ | | Department of Psychiatry
Basement of the Hospital buiding Room no 004 Kalinga Institute of Medical Sciences KIIT Deemed to be Univerity Patia BHUBANESWAR PIN 751024 → | ramachandra.das@kims.ac.in→ | 8411044558→ | Kalinga Institute of Medical Sciences KIIT Deemed to be University→ | Inclusion criteria: All Health Care Workers deployed in COVID-19 duty and willing to participate in the study→ | Exclusion criteria: Those Health Care Workers not willing to give consent→ | | Intervention1: NIL: NIL<br>→ | Status of general psychological health among health care workers (HCWs) during COVID-19 epidemic <br/ ><br>Severity of anxiety among HCWs during COVID- 19 epidemic <br/ ><br>Status of psychological health of HCWs during COVID-19 epidemic <br/ ><br>Timepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/06/026191 | 27 January 2021 | To study the safety and efficacy of Vitamin D3, Vitamin K2-7 & magnesium , in prevention of COVID 19 infection in health care professional (HCP) | Randomized, Double Blind, Comparative, Parallel group study of Vitamin D3 ( Cholecalciferol ) Vitamin K2-7 & magnesium in prophylaxis of COVID-19 infection in health care professionals - Covid19 | | Suraksha Pharma Private Limited | 27-06-2020 | 20200627 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45075 | Not Recruiting | No | | | | 01-08-2020 | 500 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | AVN Sridhar→ | | Suraksha Towers,
Ameerpet → | svp@surakshapharma.com→ | | suraksha pharma private limited→ | Inclusion criteria: 1. Participants of either sex, 20 to 60 years of age who are at high risk. High-risk individuals are defined as all health care professionals in hospitals, clinics, and emergency rooms, and medical facilities involved in management of COVID -19 patients. <br/ ><br>(Doctors, nursing staff, paramedical staff, ambulance staff, other hospital staff, ward attendees coming in contact with COVID -19 patients). <br/ ><br>2. Participants who are negative for RT-PCR test for COVID-19 infection <br/ ><br>3. Participants who are willing to provide inform consent and willing to come for schedule follow up visit. <br/ ><br>4. Participant not having contra indication to take Vitamin D, <br/ ><br>5. Participants having no COVID- 19 infection clinically. <br/ ><br>6. Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study. <br/ ><br>→ | Exclusion criteria: 1 Participants with known allergy or contraindication to Vitamin D ,Vitamin K2-7 & Magnesium . <br/ ><br>2 History of having received any investigational drug in the preceding one month. <br/ ><br>3 History of taking any kind of formulation or any other form of therapy for COVID- 19 prophylaxis. <br/ ><br>4 Unwilling to come for regular follow-up for the entire duration of the study. <br/ ><br>5 Any condition that, in the opinion of the investigator, does not justify the subjectâ??s inclusion in the study. <br/ ><br>6 Participants participating in other clinical study. <br/ ><br>7 Participant receiving other immune enhancers. <br/ ><br>8 Refusal to sign informed consent form <br/ ><br>9 Any previous positive test for COVID-19 by RT- PCR <br/ ><br>10 Symptomatic for COVID-19 <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: Vitamin D3 ( Cholecalciferol VITAMIN D3)<br> 60,000 I U/ weekly for 5 Weeks <br> 2 Vitamin K2-7 100 mcg / day for 5 weeks<br> 3 Magnesium Glycinate 250 mg/day for 5 weeks<br>: 1 Vitamin D(Cholecalciferol Vitamin D3 )60,000 I U. , weekly with milk for 5 weeks <br>2 Vitamin K2-7 100 mcg / day for 5 weeks<br>3 Magnesium glycinate 250 mg / day for 5 weeks<br><br>→ | To study the safety and efficacy of Vitamin D3, Vitamin K2-7 & magnesium , in prevention of COVID 19 infection in health care professional (HCP)Timepoint: Development of COVID- 19 infection in 5 weeks study period .→ | | | | Yes | False | | |
| → | CTRI/2020/06/026192 | 27 January 2021 | The study of C21 in hospitalised subjects with COVID-19 infection not requiring mechanical ventilation | A randomised, double-blind, placebo-controlled, phase 2 trial investigating the safety and efficacy of C21 in hospitalised subjects with COVID-19 infection not requiring mechanical ventilation - The ATTRACT Trial | | Vicore Pharma AB | 28-06-2020 | 20200628 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44815 | Not Recruiting | No | | | | 13-07-2020 | 100 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 2 | India;Russian Federation;Ukraine;United Kingdom→ | Mr Gajendrasinh Chanchu→ | | Clinical and Data Operations
QED Clinical Services India Private Limited,
Office no B-209, Westgate Besides YMCA Club S. G. Highway Ahmedabad, Gujarat India→ | rranjesh@orphan-reach.com→ | 8106656954→ | QED Clinical Services India Private Limited→ | Inclusion criteria: 1) Written informed consent, consistent with ICH-GCP R2 and local laws, obtained before the initiation of any trial related procedure. <br/ ><br>2) Diagnosis of coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test less than 4 days before Visit 1 with signs of an acute respiratory infection. <br/ ><br>3) Age more than equal to 18 and less than equal to 70 years. <br/ ><br>4) CRP more than 50 and less than 150 mg/l. <br/ ><br>5) Admitted to a hospital or controlled facility (home quarantine is not sufficient) <br/ ><br>6) In the opinion of the Investigator, the subject will be able to comply with the requirements of the protocol.→ | Exclusion criteria: 1) Any previous experimental treatment for COVID-19 <br/ ><br>2) Need for mechanical invasive or non-invasive ventilation <br/ ><br>3) Concurrent respiratory disease such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days)prior to COVID-19 diagnosis <br/ ><br>4) Participation in any other interventional trial within 3 months prior to Visit 1 <br/ ><br>5) Any of the following findings at Visit 1: <br/ ><br>a. Positive results for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCVAb) or human immunodeficiency virus 1 and 2 antigen/antibody (HIV 1 and 2 Ag/Ab) <br/ ><br>b Positive pregnancy test (see Section 8.2.3). <br/ ><br>6) Clinically significant abnormal laboratory value at Visit 1 indicating a potential risk for the subject if enrolled in the trial as evaluated by the Investigator <br/ ><br>7) Concurrent serious medical condition with special attention to cardiac or ophthalmic conditions (e.g. contraindications to cataract surgery), which in the opinion of the Investigator makes the subject inappropriate for this trial <br/ ><br>8) Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I <br/ ><br>9) Treatment with any of the medications listed below within 1 week prior to Visit 1: <br/ ><br>a. Strong Cytochrome p450 (CYP) 3A4 inducers (e.g. rifampicin, phenytoin, St. Johnâ??s Wort, phenobarbital, rifabutin, carbamazepine, anti HIV drugs, barbituates) <br/ ><br>b. Warfarin <br/ ><br>10) Pregnant or breast-feeding female subjects <br/ ><br>11) Female subjects of childbearing potential not willing to use contraceptive methods as described in Section 5.3.1 <br/ ><br>12) Male subjects not willing to use contraceptive methods as described in Section 5.3.1 <br/ ><br>13) Subjects known or suspected of not being able to comply with this trial protocol (e.g. due to alcoholism, drug dependency or psychological disorder).→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: C21: IMP will be administered twice daily orally for 7 days from Visit 2 to Visit 8 as follows:<br>1. Morning dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hours fasting<br>2 Afternoon/evening dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hours fasting Subjects will be required not to eat anything for 1 hour after taking the IMP.<br>Control Intervention1: Placebo: IMP will be administered twice daily orally for 7 days from visit 2 to visit 8 as follows: 1. Morning dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hours fasting 2 Afternoon/evening dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hours fasting Subjects will be required not to eat anything for 1 hour after taking the IMP.<br>→ | Change from baseline in C-reactive protein (CRP) after treatment with C21 200 mg daily dose (100 mg b.i.d.).Timepoint: The primary endpoint will be the change in CRP from baseline to the average of the last 2 assessments during the treatment period.→ | | 30/09/2020 | | Yes | False | | |
| → | CTRI/2020/06/026194 | 27 January 2021 | Using N-acetylcysteine as therapeutic drug for COVID-19 patients. | A randomized, double blind, placebo controlled, comparative study to investigate the efficacy of N-acetylcysteine in COVID-19 patients with standard therapy. | | Index Medical College and research centre Indore | 28-06-2020 | 20200628 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44341 | Not Recruiting | No | | | | 30-06-2020 | 200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Double Blind Double Dummy | N/A | India→ | Neha Jaiswal→ | | Dept. of Pharmacology,
Index Medical College, Hospital and Research Centre,
Nemawar Road Indore (MP) → | drpremnyati@gmail.com→ | 9826230936→ | Index Medical College and research centre, Indore→ | Inclusion criteria: patients of both genders who aged between 10 years to 55 years with confirmation of COVID-19 infection through RT-PCR test. Mild to moderate severity of disease who are willing to participate in study by giving written informed consent. <br/ ><br>→ | Exclusion criteria: seriously ill patients requiring ventilators support. <br/ ><br>Children below 10 years, adults > 55 years of age. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: N-acetylcysteine: N-acetyl cysteine (NAC)oral administration in dose of 600 mg daily twice a day for 10 days.<br>Control Intervention1: glucose capsule: similar capsule containing glucose 600 mg will be given oral daily twice a day for 10 days.<br>→ | 1. Effect of NAC in the study group on alleviating patientâ??s signs and Symptoms of COVID-19 in forms of severity and duration. <br/ ><br>2. Rate of cure from the disease as measured by negative results of RT-PCR test on nasopharyngeal swabs <br/ ><br>Timepoint: 5-7days from start of dose administration→ | | | | Yes | False | | |
| → | CTRI/2020/06/026195 | 27 January 2021 | Homoeopathy as an add-on in treatment of COVID-19 | Effectiveness of Individualized homoeopathy as an add-on to standard treatment of COVID-19 - A multicentric, randomized, parallel arm, single blind, placebo, controlled study | | Central Council for Research in Homoeopathy | 28-06-2020 | 20200628 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45129 | Not Recruiting | No | | | | 08-07-2020 | 300 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant Blinded | Phase 2/ Phase 3 | India→ | Dr Anupriya→ | | 61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 → | anil23101961@gmail.com→ | 09911127619→ | CCRH→ | Inclusion criteria: 1. Hospitalized symptomatic patients with COVID-19 infection <br/ ><br>2. Age between 18 years to 80 years <br/ ><br>3. Both the sexes <br/ ><br>4. Willing to give written informed consent <br/ ><br>→ | Exclusion criteria: 1. Severe heart, lung, kidney, brain, blood diseases or other important systemic diseases <br/ ><br>2. Patients on ventilatory support <br/ ><br>3. Immunocompromised patients <br/ ><br>4. Subjects considered to be unable to complete the study, or not suitable for the study by researchers. <br/ ><br>5. Women during pregnancy. <br/ ><br>6. Lactating mothers <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Homoeopathic medicine along with standard care: Homoeopathic medicines will be<br>given to this group patients as<br>an add-on to standard treatmet.<br>Following Individualization<br>medicines will be selected<br>keeping in view pathological<br>aspect of disease. Dose and<br>potency will be according to the<br>frequency, intensity and<br>duration of signs and<br>symptoms. Repetitions will vary<br>from cae to case basis<br>cosidering disease state and<br>vitality of patient. Range of<br>potency from 30, 200, 1M etc<br>will be used.<br>Control Intervention1: Placebo along with standard care: Placebo group patients will<br>receive identical placebo (globules moistened with<br>dispensing alcohol) as an add<br>on to standard protocol<br>treatment. Dose repetition will be a in similar pattern to medicine group.<br>→ | Clinical recovery of patient or requirement of life support (ventilator)/ death.Timepoint: Ever 24 hr.→ | | | | Yes | False | | |
| → | CTRI/2020/06/026198 | 27 January 2021 | Conscious posture therapy and covid 19 hypoxemia | Effectiveness of Conscious posture therapy to counter Covid 19 Hypoxemia in early stage of disease: a single-center prospective cohort study | | PGIMER CHANDIGARH | 28-06-2020 | 20200628 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43651 | Not Recruiting | No | | | | 10-07-2020 | 60 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Kulbhushan saini→ | | Department of anesthesia,
4th Floor, Nehru Hospital, PGIMER, Chandigarh → | kulbhushansaini007@gmail.com→ | 9968856948→ | PGIMER, CHANDIGARH→ | Inclusion criteria: Confirmed covid patient with hypoxia <br/ ><br>1. who have the following O2 requirements: <br/ ><br>i. Nasal Cannula O2 <br/ ><br>ii. Venti Mask <br/ ><br>iii. Non-Rebreather Mask <br/ ><br> <br/ ><br>2. Bilateral infiltrate on chest Xray <br/ ><br>3. Grossly hemodynamically stable <br/ ><br>4. Able to adjust their own position <br/ ><br>5. Can communicate on their own <br/ ><br>→ | Exclusion criteria: <br/ ><br>1. Patient refusal to participate <br/ ><br>2. Patient unable to co-operate <br/ ><br>3. Respiratory distress (RR â?¥ 40, accessory muscle use) â?? <br/ ><br>4. Immediate need for intubation â?? <br/ ><br>5. Haemodynamic instability (SBP < 90mmHg) or arrhythmia â?? <br/ ><br>6. Agitation or altered mental status <br/ ><br>7. Unstable spine/thoracic injury/recent abdominal surgery <br/ ><br>8. Pregnancy (2/3rd trimester) <br/ ><br>9. Multiorgan failure <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | â?¢ Assessment of an improvement in their SpO2 ie change in O2 saturation from presentation to post-application of supplemental O2 and after 15 minutes of each defined position in conscious posture therapy without changing the inspired oxygen fraction.Timepoint: after 15 minutes→ | | | | Yes | False | | |
| → | CTRI/2020/06/026196 | 27 January 2021 | Prevention of Respiratory Complications In At Surgery in COVID-19 Pandemic | Preventing Pulmonary Complications In Surgical Patients At Risk Of COVID-19 - PROTECT-Surg | | University Of Birmingham | 28-06-2020 | 20200628 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43482 | Not Recruiting | No | | | | 15-08-2020 | 6400 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3/ Phase 4 | Benin;Ghana;India;Italy;Mexico;Nigeria;Rwanda;South Africa;United Kingdom→ | Amit Mahajan→ | | Christian Medical College Hospital
Brown Road
→ | dr_amitrock@yahoo.co.in→ | 9988018700→ | Christian Medical College Ludhiana→ | Inclusion criteria: 1. Patients aged 16 years and over. <br/ ><br>2. Planned to undergo any type of elective or emergency inpatient surgery requiring general or regional anaesthesia (such as vulnerable patients undergoing surgery for a fractured neck of femur). <br/ ><br>3. Asymptomatic of COVID-19, including patients with: those not tested, negative test results, positive test but no symptoms <br/ ><br>4. Informed patient consent. <br/ ><br>→ | Exclusion criteria: 1. Procedures under local anaesthesia. <br/ ><br>2. Symptomatic COVID-19 infection (by confirmed COVID-19 test or a clinical diagnosis) <br/ ><br>3. Existing regular preoperative treatment with trial drugs. <br/ ><br>4. Known history of adverse reaction/contraindication to trial drugs. <br/ ><br>5.Pregnancy (including caesarean section). <br/ ><br>â?¢ Actively breastfeeding. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: O- Medical and Surgical
→ | Intervention1: Lopinavir-Ritonavir: Lopinavir is a HIV-1 (Human Immunodeficiency Virus 1) protease inhibitor, normally used as part of combined drug therapy for HIV. Ritonavir is added to Lopinavir to enhance efficacy by increasing serum availability [3]. In-vitro experiments show viral susceptibility to the drug. A published series of patients treated with this Lopinavir-Ritonavir showed improved outcomes at 21 days after diagnosis, compared to historical controls. Lopinavir-Ritonavir has previously been shown to improve outcomes in animal models (marmosets) infected with MERS-CoV. A trial including 194 patients with advanced COVID-19 infection showed a small difference in time to clinical improvement, suggesting the need for further trials evaluating this drug. Though early studies have not shown any difference in post treatment viral load, some centres are using this drug combination off-label to treat COVID-19 patients. No work has yet looked at the impact of these drugs on pre-infection or pre-symptomatic treatment (or in vulnerable patients). Robust evidence is needed to prove or exclude the benefit of Lopinavir-Ritonavir use to prevent pulmonary complications in patients undergoing surgery.<br>Intervention2: Hydroxychloroquine: Hydroxychloroquine is usually used as an antimalarial drug and in auto-immune diseases such as Lupus and Rheumatoid Arthritis. Promising laboratory studies have shown that chloroquine decreases COVID-19 entrance and replication within cells, together with its known anti-inflammatory effect. From small early phase clinical trials in China that included more than 100 patients being treated for COVID-19 pneumonia, chloroquine was associated with a shorter course of disease and less pneumonia exacerbation. A subsequent small non-randomised study → | One of the following COVID-19 specific, inpatient, postoperative pulmonary complications: Pneumonia, Acute respiratory distress syndrome, Death <br/ ><br>Timepoint: All randomised participants will be followed up until death, discharge from hospital, or 30 days post-randomisation (whichever is sooner). Longer-term follow-up (e.g. 5 years) will be sought as appropriate to each participating countryâ??s settings.→ | | | | Yes | False | | |
| → | CTRI/2020/06/026193 | 27 January 2021 | A study of drug Lithium on patients of Covid 19 disease | A randomized control study to evaluate the therapeutic effects of Lithium in Covid-19 patients | | Maulana azad medical college | 28-06-2020 | 20200628 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44766 | Recruiting | No | | | | 30-07-2020 | 100 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Sumit Sural→ | | Dept of Orthopedics
Lok Nayak Hospital
Delhi → | sumitsural@hotmail.com→ | 9968604323→ | Maulana Azad Medical College and associated Lok Nayak Hospital→ | Inclusion criteria: 1.Age between 18 and 70yrs <br/ ><br>2.Positive Covid test report as per reverse transcriptase polymerase chain reaction (RT PCR) of oronasopharyngeal swabs. <br/ ><br>3.Respiratory rate more than 30 per minute. <br/ ><br>4.SpO2 93% or less. <br/ ><br>→ | Exclusion criteria: 1.Known case of hypothyroidism <br/ ><br>2.Renal insufficiency; Serum creatinine levels more than 1.3 mg/dl <br/ ><br>3.Cardiac arrhythmia and cardiac disease <br/ ><br>4.Patients on NSAID <br/ ><br>5.Known history of QTc prolongation on ECG <br/ ><br>6.Contraindication or allergy to hydroxychloroquine <br/ ><br>7.Retinal eye disease <br/ ><br>8.Pregnancy/breastfeeding→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | Intervention1: Group L: Tablet Lithium carbonate 600mg twice daily as add on therapy with Tablet Hydyoxychloroquine 400mg once daily with or without Azithromycin 500mg once daily for 5 days<br>Control Intervention1: Standard care of therapy(Group s): Tablet Hydroxychloroquine 400mg once daily with or without Tablet Azithromycin 500mg OD for 5 and placebo for 5 Days<br>→ | MortalityTimepoint: At week 3→ | | | | Yes | False | | |
| → | CTRI/2020/06/026197 | 27 January 2021 | Validation of Classical Ayurvedic formulations in treatment of COVID-19 | To Evaluate the Efficacy of SUDARSHAN GHAN VATI and VYAGHRADI KWATH in the management of patients with COVID-19- A Pilot study. | | Ministry of AYUSH GoI | 28-06-2020 | 20200628 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45052 | Not Recruiting | No | | | | 06-07-2020 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Dr Amanpreet Kaur→ | | 127/3, Trikuta Nagar, Jammu Department of Shalyatantra, Government Ayurvedic Medical College
Indira Chowk,
Jammu→ | contactdramanpreet@gmail.com→ | 9811933102→ | Department of Indian Systems of Medicine, J&K, Jammu→ | Inclusion criteria: 1. Patients of COVID-19 positive cases with mild to moderate symptoms <br/ ><br>2. Patients who can take medicine orally <br/ ><br>3. Patients willing to provide signed informed consent <br/ ><br>→ | Exclusion criteria: 1. Patients with severe symptom <br/ ><br>2. Immuno compromised patients <br/ ><br>3. Pregnant / Lactating females <br/ ><br>4. COVID-19 negative patients <br/ ><br>→ | Health Condition 1: Z208- Contact with and (suspected) exposure to other communicable diseases
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Sudarshan Ghanvati and Vyaghradi Kwath: Sudarshan Ghanvati 500 mg Tablet 2 TDS, Orally<br>Vyaghradi Kwath 60 ml BD, Orally<br><br>Duration- For 30 days.<br><br>Control Intervention1: Conventional treatment for covid 19: Conventional treatment for covid 19<br>→ | Decrease in duration of conversion from COVID positive to negativeTimepoint: 4 Weeks→ | | | | Yes | False | | |
| → | CTRI/2020/06/026228 | 27 January 2021 | Study in Hospitalized COVID-19 patients with Acalabrutinib along with the Best Supportive Care versus Best Supportive Care | A Phase II, Open Label, Randomized Study of the Efficacy and Safety of Acalabrutinib with best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19 | | Acerta Pharma BV | 29-06-2020 | 20200629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44554 | Not Recruiting | No | | | | 29-06-2020 | 140 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2 | Brazil;France;Germany;India;Italy;Japan;Russian Federation;Spain;Sweden;Turkey→ | Tapankumar M Shah→ | | Block N1, 12th Floor, Manyata Embassy Business Park,
Rachenahalli, Outer Ring Road.
→ | tapankumar.shah@astrazeneca.com→ | 91-9535104975→ | AstraZeneca Pharma India Ltd→ | Inclusion criteria: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent. <br/ ><br>2. Men and women â?¥18 years of age <br/ ><br>3. SARS-CoV-2 confirmed per World Health Organization (WHO) criteria within 4 days of randomization. <br/ ><br>4. COVID-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen. <br/ ><br>5. Able to swallow pills. <br/ ><br>6. Willing to follow contraception guidelines <br/ ><br> <br/ ><br>→ | Exclusion criteria: COVID-19 Related Medical Conditions <br/ ><br>1. Respiratory failure at the time of screening due to COVID-19 pneumonia. <br/ ><br>2. Known medical resuscitation within 14 days of randomization. <br/ ><br>3. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigators judgment, precludes the subjects safe participation in and completion of the study <br/ ><br>4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with SARSCoV2). <br/ ><br>5. In the opinion of the Investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments <br/ ><br> <br/ ><br>Medical Conditions <br/ ><br>6. Not expected to survive 28 days given their pre-existing, uncorrectable medical condition. <br/ ><br>7. Pregnant or breast feeding. <br/ ><br>8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin â?¥ 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh class C). <br/ ><br>9. Absolute neutrophil count (ANC) < 500/μL at screening (per local laboratory). <br/ ><br>10. Platelet count < 50,000/μL at screening (per local laboratory). <br/ ><br>11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault formula [(140age) Ã? mass (kg)/(72 Ã? creatinine mg/dL) multiply by 0.85 if female]. <br/ ><br>12.Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). <br/ ><br>Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening area allowed to enrol on study. <br/ ><br>13.History of chronic hypercarbia, respiratory failure in past 6 months, or use of home oxygen in the setting of severe chronic respiratory disease. <br/ ><br>14.Quadriplegia. <br/ ><br>15.History of primary immunodeficiency, tuberculosis, progressive multifocal leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or received organ or bone marrow transplantation within 6 months of randomization. <br/ ><br>16.Known active hepatitis B or C infection requiring therapy. <br/ ><br> <br/ ><br>Prior/Concomitant Therapy: <br/ ><br> <br/ ><br>17.Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before first dose of study drug) or inducer (within 7 days before first dose of study drug). <br/ ><br>18.Requires treatment with proton-pump inhibitors. <br/ ><br>19.Received oral antirejection or immunomodulatory drugs. <br/ ><br>20.Active participation in other drug clinical trials or received treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization/enrolment. <br/ ><br>21.Subjects at randomization who require inhaled corticosteroids or maintenance doses of more than 7.5 mg of prednisone or equivalent per day. <br/ ><br>22.Requires or is receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of acalabrutinib. <br/ ><br>23.History of hypersensitivity (ie, allergic response) to active or inactive excipients of acalabrutinib or other Btk inhibitors. <br/ ><br>24.Known cytoreductive chemotherapy treatment within 14 days of randomization. <br/ ><br>25.Major surgery (as defined by the Investigator) within 4 weeks prior to randomization or still recovering from prior surgery.→ | Health Condition 1: J960- Acute respiratory failure
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Acalabrutininb (ACP-196): 1:1Assignment<br>Route of Administration: Oral. <br>Duration of therapy: 10 days <br>Frequency:Twice daily (BID)<br>Control Intervention1: Best Supportive Care: 1:1 Assignment<br>Duration of therapy: 10 days<br>→ | The overall objective of the study is to evaluate the efficacy of adding acalabrutinib to BSC for the treatment of COVID-19. <br/ ><br>For the purpose of this study, respiratory failure, is defined based on resource utilization of any of the following modalities: <br/ ><br> (a) Endotracheal intubation and mechanical ventilation <br/ ><br> (b) Oxygen delivered by high-flow nasal cannula <br/ ><br> (c) Non-invasive positive pressure ventilation or continuous positive airway pressure <br/ ><br> (d) Extracorporeal membrane oxygenation <br/ ><br>Timepoint: Proportion of subjects alive and free of respiratory failure at Day 14→ | | | | Yes | False | | |
| → | CTRI/2020/06/026222 | 27 January 2021 | Intravenous Immunoglobulin Therapy in the treatment of Moderate Pneumonia in COVID-19 patients | A Phase II Safety and Efficacy Study on prognosis of Moderate Pneumonia in COVID-19 patients with Regular Intravenous Immunoglobulin Therapy | | Virchow Biotech Private Limited | 29-06-2020 | 20200629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44299 | Not Recruiting | No | | | | 29-06-2020 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2 | India→ | Dr Aditi→ | | Room Number 1, Biosite Research Pvt Ltd
740, 2nd Floor,
14th Main Road, Kumarswamy Layout,
Bangalore -560078.→ | hnandigala@gmail.com→ | 04023119481→ | Virchow Biotech Private Limited→ | Inclusion criteria: Both male or female patients who signed the informed consent and aged â?¥18 years ; <br/ ><br>Patients admitted with RT-PCR confirmed COVID-19 illness. <br/ ><br>Patient with any of the following : <br/ ><br>Fever â?¥36.7â?? axilla or Oral temperature â?¥ 38.0 â?? <br/ ><br>PaO2/ FiO2: 100-300 mmHg <br/ ><br>Respiratory Rate >24/min and SaO2 90- 93% on room air <br/ ><br>Lung involvement confirmed with chest X-ray. <br/ ><br>(X-ray interpretation as mentioned in ICMR guideline-bilateral opacities, not fully explained by effusions, lobar or lung collapse, or nodules) <br/ ><br>→ | Exclusion criteria: Viral pneumonia with other viruses besides COVID-19 <br/ ><br>Patients are not suitable for immunoglobulin therapy. <br/ ><br>Patients with severe pneumonia defined as : RR â?¥ 30 times/min or oxygen saturation â?¤ 90% in resting state or PaO2/FiO2 â?¤ 100 mmHg or respiratory failure and mechanical ventilation are required or shock occurs or ICU monitoring with prescence of other organ failure. <br/ ><br>Patients on either immunoglobulin or hydroxychloroquine treatment <br/ ><br>Pregnant or lactating women or other circumstances in which the investigator determined that the patient is not suitable for the clinical trial. <br/ ><br>Participation in other studies. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Immunoglobulin and standard of care: Dose:0.4 g/kg body weight <br>Frequency once in a day<br>Duration 5 days <br>Route IV route<br>Control Intervention1: Standard of Care: Azithromycin 500 mg once a day for 5 days<br>Lopinavir/ritonavir 200 mg/50 mg - two tablets every 12 h for 14 days or for seven days after becoming asymptomatic, whichever is earlier; and (ii) For patients who are unable to take medications by mouth, 400 mg lopinavir /100 mg ritonavir 5 ml suspension every 12 h for 14 days or seven days after becoming asymptomatic whichever is earlier<br>Piperacillin + Tazobactam 4.5 mg in 100 ml NS three times a day for 5 days<br>Paracetamol 1gm tablet thrice a day; Pantocid 40 mg tablet once a day<br><br>→ | Number of days to clinical improvement. <br/ ><br>It is defined as no. of days from initiation of treatment day to discharge day on a six-category ordinal scale <br/ ><br>Timepoint: 0-28 days→ | | 12/09/2020 | | Yes | False | | |
| → | CTRI/2020/06/026227 | 27 January 2021 | A Study on Unani regimen
for prevention of high/moderate risk population of COVID 19 | A Study on prophylactic interventions of Unani Medicine on high/moderate risk population of COVID 19 | | Central Council for Research in Unani Medicine CCRUM New Delhi | 29-06-2020 | 20200629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44584 | Not Recruiting | No | | | | 07-07-2020 | 60 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Pradeep Kumar→ | | Room No. 516, Jawahar Lal Nehru Bhartiya Chikitsa Evam Homoeopathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri → | ccrum507@rediffmail.com→ | 9213511298→ | CCRUM→ | Inclusion criteria: 1.Population as described as High/ Moderate Risk group <br/ ><br>2.Individuals who are from the identified quarantine facility <br/ ><br>3.Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study→ | Exclusion criteria: 1.Persons with severe primary respiratory disease or related complications that may be <br/ ><br>identified with COVID-19 <br/ ><br>2.Laboratory confirmed COVID-19 with or without symptoms <br/ ><br>3.Pregnant and lactating mothers and those who have a pregnancy plan. <br/ ><br>4.Persons with serious critical illness, or severe mental illnesses <br/ ><br>5.Individuals with clinical history of uncontrolled/ unstable co-morbidities <br/ ><br>6.Known Immuno-compromised individuals or those on immune-suppressantdrugs and steroids <br/ ><br>7.Subjects having a past history of allergy to any medicine that is a part of the Unani <br/ ><br>intervention.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Khameera Marwareed: 5g orally once daily in the morning for 14days<br>Intervention2: Tiryaq-e-Arba: 5gm orally with lukewarm water in the Morning for 14days<br>Intervention3: Unani Joshanda/decoction (Behidana (Cydonia oblonga) 3 gm, Unnab (Zizyphus jujube)<br>5 in number, Sapistan (Cordia myxa)9 in numbers: lukewarm decoction once<br>daily in the Evening for 14days<br><br>Intervention4: Conventional treatment being given in quarantine centers in Delhi: As per Centre/State Govt policy<br>Control Intervention1: Conventional treatment being given in quarantine centers in Delhi: As per Centre/State Govt policy<br>→ | Incidence of COVID-19 cases in control as well in interventional group <br/ ><br>Timepoint: 14 days→ | | 27/07/2020 | | Yes | False | | |
| → | CTRI/2020/06/026229 | 27 January 2021 | A clinical trial of Ayurveda formulations in COVID-19 | Effect of Malla Chandrodaya & Ashtadashang ghan vati in Patients with mild to moderate Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infections | | Dr Namrata Joshi | 29-06-2020 | 20200629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45105 | Recruiting | No | | | | 10-07-2020 | 100 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Namrata Joshi→ | | Dept. of Rasashastra
Faculty of Ayurveda
IMS,BHU,Varanasi → | drnamratajoshi@gmail.com→ | 9319037367→ | BHU→ | Inclusion criteria: i. Laboratory-confirmed mild to moderate symptomatic cases of COVID-19 above <br/ ><br>between 18years irrespective of sex will be included. <br/ ><br>ii. Patients able to take medicines orally. <br/ ><br>iii. Patients willing to provide signed informed consent may be included in the Inclusion <br/ ><br>criteria.→ | Exclusion criteria: i. Cases of severe vomiting which would affect oral administration of medicine difficult. <br/ ><br>ii. Cases of respiratory failure and requiring mechanical ventilation <br/ ><br>iii. Combined organ failure requiring ICU monitoring. <br/ ><br>iv. Any other condition, which as per the investigator would jeopardize the outcome of <br/ ><br>the trial.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Combination of Malla Chandrodaya &<br>Ashthadashang Ghana vati with anupana of Parijata Swaras.: Malla Chandrodayaa 32 mg & Ashtadashang Ghana Vati 500 mg twice daily with anupana of Parijata swaras, oral mode of administration<br>Control Intervention1: Standard care for COVID 19 patients as per Government of India advisory: Drugs advised by Government of India in its advisory for COVID 19 patients<br>→ | 1. All-cause mortality <br/ ><br>2. WHO Ordinal Scale for Clinical Improvement of COVID-19Timepoint: Daily until discharge→ | | | | Yes | False | | |
| → | CTRI/2020/06/026220 | 27 January 2021 | A study to evaluate the efficacy and safety of Nafamostat Mesilate in treatment of Coronavirus infection | An Open Label, Randomized, Multicenter, Controlled Clinical Study to Evaluate the Efficacy and Safety of Nafamostat Mesilate in the Treatment of Moderate COVID-19 Disease | | Sun Pharmaceutical Industries Limited | 29-06-2020 | 20200629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44350 | Not Recruiting | No | | | | 17-07-2020 | 40 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | Phase 2 | India→ | Guruprasad Palekar→ | | Sun Pharma Laboratories Limited
Sun House,
201 B/1, Western Express Highway,
Goregaon (E), Mumbai 400063
→ | maulik.doshi@sunpharma.com→ | 02656612829→ | Sun Pharma laboratories Limited→ | Inclusion criteria: Subjects will be included in the study if they meet all of the following criteria: <br/ ><br>1. Male or non-pregnant, non-lactating female patient aged â?¥ 18 and â?¤ 65 years <br/ ><br>2. Patient presenting with symptoms of fever (axillary â?¥ 98.6°F or oral â?¥ 99.5°F) with <br/ ><br>cough/shortness of breath <br/ ><br>3. Patient with Moderate COVID -19 infection meeting the clinical criteria of (note) - <br/ ><br>a. Pneumonia (confirmed on chest imaging) and <br/ ><br>b. Respiratory rate 15 to 30 breaths/minute (both inclusive) and <br/ ><br>c. Oxygen saturation- SpO2 90%-94% (both inclusive) on room air OR PaO2/ FiO2: 200- <br/ ><br>300 mmHg (both inclusive) <br/ ><br>4. Patient with RT-PCR confirmed diagnosis of COVID-19 <br/ ><br>5. Patient randomized within 72 hours of diagnosis of pneumonia <br/ ><br>6. Patient who provides written informed consent and agrees to comply with study procedures <br/ ><br>7. Women of childbearing potential must have a negative urine pregnancy test prior to study entry <br/ ><br> as per MOHFW guideline <br/ ><br>Note: (https://www.mohfw.gov.in/pdf/FinalGuidanceonMangaementofCovidcasesversion2.pdf)→ | Exclusion criteria: Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria: <br/ ><br>1 Patient requiring extracorporeal membrane oxygenation (ECMO) or invasive ventilation <br/ ><br>2 Patient with multiple organ failure requiring ICU monitoring and the treatment <br/ ><br>3 Patient with rapidly deteriorating clinical condition or low likelihood to complete the study according to the investigator <br/ ><br>4 Patient with eGFR < 30 ml/min/m2 assessed with CKD EPI formula <br/ ><br>5 Patient with Pre-existing renal failure on hemodialysis or peritoneal dialysis requiring renal replacement therapy <br/ ><br>6 Patient with Current or chronic history of liver disease (Child Pugh score â?¥ 10), or known hepatic or biliary abnormalities <br/ ><br>7 Patient with known active hepatitis, tuberculosis and definite bacterial or fungal infections <br/ ><br>8 Patient with history of chronic interstitial lung disease on imaging <br/ ><br>9 Patient with history of hospitalization for respiratory failure within the past six months <br/ ><br>10 Patient with history of chronic vascular disease resulting in severe exercise restriction (i.e. unable to <br/ ><br>perform household duties) <br/ ><br>11 Patient with history of secondary polycythemia, severe pulmonary hypertension, or ventilator dependency <br/ ><br>12 Patient with history of vasculitis with diffuse alveolar hemorrhage <br/ ><br>13 Patient with severe active bleeding at screening or with bleeding tendency (platelet count < 50,000/ul, INR â?¥ 3, aPTT > 65 seconds) <br/ ><br>14 Patient with diabetes <br/ ><br>15 Patient with any concurrent medical condition or uncontrolled, clinically significant systemic disease [e.g., heart failure (NYHA III/IV), COPD, hypertension (â?¥ 160/100 mm Hg), chronic respiratory failure, anaemia (â?¤ 8 g/dl) etc.) that, in the opinion of the Investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results <br/ ><br>16 Patient with history of serology tests positive for hepatitis B or hepatitis C or human immunodeficiency virus <br/ ><br>17 Patient with altered mental state <br/ ><br>18 Patient with history of retinopathy or macular degeneration <br/ ><br>19 Patient with history of glucose-6-phosphate dehydrogenase (G6PD) deficiency <br/ ><br>20 Patient with prolonged QTc-interval at baseline ECG ( >450 ms in males or > 470 ms in females) <br/ ><br>21 Patient taking concomitant medication associated with QTc-interval prolongation, which cannot be withdrawn prior to study drug administration <br/ ><br>22 Patient requiring high doses of loop diuretics (i.e. > 240 mg furosemide daily) with significant intravascular volume depletion, as assessed clinically <br/ ><br>23 Patient taking immunosuppressive treatment <br/ ><br>24 Patient having history of sensitivity to heparin or heparin-induced thrombocytopenia <br/ ><br>25 Patient with history of hypersensitivity towards any drug of standard of care or Nafamostat including their excipients <br/ ><br>26 Patient who participated in a clinical trial with an investigational product within the following time period prior to the first dosing day in the current study: 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer) <br/ ><br>27 Patient participated in trials for COVID-19 within 30 days before screening <br/ ><br>28 Patient with hyperkalemia , i.e. serum K+ levels > 5.0 mEq/L <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nafamostat Mesilate Injection 50 mg/ 100 mg vial: Dissolve a daily dose of Nafamostat mesilate in 1000 ml of 5 % dextrose and to be infused at dose of 0.1 mg/kg/hr for 24 hrs by continuous infusion for 10 days<br>If the patient meets clinical improvement/ discharge criteria any time prior to completing infusion on Day 10, the treatment can be stopped earlier and subject can be discharged and followed up as defined in protocol<br>Also, Standard of care as per institutional practice.<br>Patients may be given prophylactic LMWH (e.g., Enoxaparin 1mg/kg per day Subcutaneously) as per investigatorâ??s discretion. Before starting LMWH, investigator should check for bleeding tendency riskand presence of any contraindications. When Nafamostat and LMWH are given concomitantly daily PT/INR and aPTT should be monitored.<br>Control Intervention1: Standard of care as per institutional practice: Standard of care as per institutional practice<br><br>Patients may be given prophylactic LMWH (e.g., Enoxaparin 1mg/kg per day Subcutaneously) as per investigatorâ??s discretion. Before starting LMWH, investigator should check for bleeding tendency riskand presence of any contraindications. When Nafamostat and LMWH are given concomitantly daily PT/INR and aPTT should be monitored.<br>→ | Proportion of patients showing clinical improvementTimepoint: by Day 14→ | | 05/09/2020 | | Yes | False | | |
| → | CTRI/2020/06/026232 | 27 January 2021 | Ivermectin in the prevention of covid-19 | A Clinical Trial to Study the Efficacy of â??Ivermectinâ?? in the prevention of Covid-19. .A Single Arm Study. â?? | | DVFM | 29-06-2020 | 20200629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45156 | Not Recruiting | No | | | | 10-07-2020 | 50 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | BKumar→ | | Department of Medicine, Sivajipalem Main road,
→ | bkumar09460946@gmail.com→ | 9505637454→ | DVFM→ | Inclusion criteria: Subjects who are not suffering from active illness due to infection at the time of inclusion .→ | Exclusion criteria: 1.Pregnant and lactating women. <br/ ><br>2.Subjects suffering from active illness due to infection at the time of inclusion. <br/ ><br>3.Subjects suffering from uncontrolled DM, HTN etc <br/ ><br>4.Subjects who are known cases of immune-compromised or autoimmune condition such as HIV.→ | | Intervention1: Ivermectin: Single oral dose of 200 mcg of ivermectin per kg of body weight.<br>Control Intervention1: Not applicable: Not applicable<br>→ | Episodes and severity of symptoms of respiratory tract infection (cold, sore throat, dry cough, breathlessness) in subjects who may get direct or indirect exposure to COVID 19 patients.Timepoint: From Baseline till the end of 15 days.→ | | | | Yes | False | | |
| → | CTRI/2020/06/026231 | 27 January 2021 | To study effect of ayurvedic treatment for prevention and management of asymptomatic, mild and moderate cases of COVID-19. | â??To study the efficacy of add on Ayurvedic treatment to
the standard of care for prevention and management of asymptomatic, mild &
moderate cases of COVID-19.â?? | | Ministry of AYUSH | 29-06-2020 | 20200629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44497 | Not Recruiting | No | | | | 15-07-2020 | 160 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Jyoti Shirodkar→ | | c/o Dr. Shirodkars Health Solutions PL, S2/11, Devideep Society, NDA
Road, Bavdhan, Pune 411021 → | drjyotishirodkar@gmail.com→ | 9822352497→ | Symbiosis medical college for women and symbiosis university hospital and research centre, pune→ | Inclusion criteria: Males or Females with age group of 18 years to 60 years. <br/ ><br>Participants, ready to sign informed consent form <br/ ><br>For Prevention Regime: Health care workers working in Hospital and are Negative for <br/ ><br>COVID-19 test. <br/ ><br>For treatment Regime: Asymptomatic, mild & moderate laboratory confirmed cases <br/ ><br>of COVID-19→ | Exclusion criteria: 1.Age below 18 years and above 60 years <br/ ><br>2.Pregnant and lactating women <br/ ><br>3. Seriously ill patients requiring intensive care <br/ ><br>4 Subjects who have participated in another investigational drug or research study <br/ ><br>within 30 days of screening.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: For Prevention regime: Ayurvedic treatment: 1.Dietary recommendations and restrictions<br>2.Morning, empty stomach: 4 black resins boiled in one cupful of water<br>3.Decoction of cinnamon, dried ginger, black pepper and cardamom at 9.00 am<br>4.A cup of hot milk with 250 mg-500 mg of turmeric powder, 2 hours after dinner.<br>5.Sanshamanivati 250-500mg twice a day with water.<br>Intervention2: For Treatment regime- Ayurvedic treatment: 1.Tab TribhuvanKirti: 125mg-250mg + Tab. Sutshekhar: 250 mg+ SitopaladiChurna :<br>500 mg (Thrice a day with hot water for 14 days).<br>2.Samshamanivati 250-500 mg, (twice a day with hot water)<br>3.If dry cough is present, shunthiksheerpak will be given for 5-7 days in addition to<br>above treatment.<br>After this treatment, patients will be given the Ayurvedic regime prescribed for prevention regime for 28 days.<br>Control Intervention1: For prevention regime-Standard of care: Standard of care as per hospital protocol<br>Control Intervention2: For treatment regime- standard of care: standard of care as per hospital protocol<br>→ | Effect of Ayurvedic treatment on eradication of virus by testing for SARS-Co-V-2 by Real time PCR test <br/ ><br>Timepoint: Day 7→ | | | | Yes | False | | |
| → | CTRI/2020/06/026221 | 27 January 2021 | Intervention of Ayurvedic Medicine (Arogya Kashayam) in Covid-19 positive cases (Asymptomatic and Mild Symptomatic) | Evaluation of efficacy of Arogya Kashayam in Asymptomatic and Mild Symptomatic Positive Cases of Covid-19 -A Randomized Control Study | | Directorate of AYUSH Government of Madhya Pradesh | 29-06-2020 | 20200629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44542 | Not Recruiting | No | | | | 01-07-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant Blinded | Phase 2 | India→ | Prof Umesh Shukla→ | | Department of Panchkarma, Room No. 101, "A" Block, Academic wing, Pt Khushilal Sharma Government Ayurveda College and Institute Science Hills Dhanwantrari Marg Bhopal 462039 → | umeshayurvedabhopal@gmail.com→ | 9425373046→ | Pt Khushilal Sharma Government Ayurveda College and Institute Bhopal→ | Inclusion criteria: Asymptomatic and Mild cases of Covid-19 <br/ ><br> <br/ ><br>Aged between 16-60 years without any discrimination of gender, caste and religion <br/ ><br> <br/ ><br>Participants able to give Informed consent and follow the instructions <br/ ><br>→ | Exclusion criteria: Severely symptomatic cases of Covid-19 (SaO2 <90%) <br/ ><br> <br/ ><br>Participants with Acute Respiratory Distress Syndrome (ARDS) <br/ ><br> <br/ ><br>Life expectancy less than 1 year due to other co-morbid conditions <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Arogya Kashayam-20: Dose : 100 ml <br>Frequency: Twice a day (morning and evening)<br>Route: Oral.<br>Duration: 10 days.<br>Control Intervention1: Hydroxychloroquine (HCQ): Dose: First day - 800 mg<br>maintenance dose for next five days - 400 mg. <br>Frequency: Twice a day in divided dose.<br>Route : Oral.<br>Duration: 6 days.<br>→ | Check the progression of the diseaseTimepoint: Base line, 3 days, 7 days→ | | 10/08/2020 | | Yes | False | | |
| → | CTRI/2020/06/026250 | 27 January 2021 | Correlation of urinary porphyrin and biochemical markers with the severity of symptoms of COVID-19 cases. | Correlation of urinary porphyrin and biochemical markers with the severity of symptoms of COVID-19 cases. | | DR JYOTIRMAYEE BAHINIPATI | 30-06-2020 | 20200630 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45057 | Not Recruiting | No | | | | 15-07-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DR JYOTIRMAYEE BAHINIPATI→ | | DEPARTMENT OF BIOCHEMISTRY
KIMS
KIIT UNIVERSITY
BHUBANESWAR → | jyotirmayee.bahinipati@kims.ac.in→ | 9437143193→ | KIMS, KIIT University→ | Inclusion criteria: Symptomatic RT PCR positive COVID-19 Cases→ | Exclusion criteria: RT PCR POSITIVE COVID-19 CASES WITH HISTORY OF PORPHYRIA, HEMOGLOBINOPATHIES. <br/ ><br>PREGNANT WOMEN <br/ ><br>THOSE WHO UNDERGO RECENT SURGERY→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Cured or deathTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/06/026256 | 27 January 2021 | Resveratrol and copper for the treatment of COVID-19 pnuemonia. | Routine use of over-the-counter Nutraceuticals, Resveretrol-Copper with standard treatment in Hospitalized Patients With Pneumonia/ Acute Respiratory Distress Syndrome Due To SARS-CoV-2 (Covid-19)- Retrospective Analysis | | TopiwalaNational Medical College and BYL Nair charitable Hospital | 30-06-2020 | 20200630 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45115 | Not Recruiting | No | | | | 10-07-2020 | 230 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rosemarie Desouza→ | | Department of Medicine, College building,First Floor, T.N.M.C and B.Y.L.Nair Hospital, Dr.A.L.Nair Road, Mumbai → | drrosemariedesouza@gmail.com→ | 9820056230→ | T.N.M.C and B.Y.L.Nair Hospital→ | Inclusion criteria: Male and non-pregnant female patients <br/ ><br>1.Have positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen <br/ ><br>2.Have pneumonia confirmed by chest imaging <br/ ><br>3.oxygen saturation (Sao2) of 94% or less while they were breathing ambient air <br/ ><br>4.have either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 3 (CTCAE Version 5.0) abnormalities in any of these parameters <br/ ><br> <br/ ><br>→ | Exclusion criteria: Asymptomatic or only mildly symptomatic→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To retrospectively access the clinical outcomes in the patients receiving R- <br/ ><br>Cu along with standard treatment versus those who received standard treatment.Timepoint: 10 Days→ | | | | Yes | False | | |
| → | CTRI/2020/06/026262 | 27 January 2021 | Single Center,Study on Evaluation of use of,â??AYURCOVâ?? as add on therapy for Treatment of SARS-CoV-2 Infection in COVID-19 Patients,at Tertiary Care Center. | Prospective , single center ,open label, randomized controlled , pilot study on evaluation of use of , â??AYURCOVâ?? as an adjuvant for treatment purpose in treatment of SARS-CoV-2 infection for covid-19 patients , at tertiary care center. - AYURCOV | | Bhaktivedanta Hospital and Research Institute | 30-06-2020 | 20200630 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43889 | Not Recruiting | No | | | | 01-07-2020 | 120 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Dr Nanasaheb Memane→ | | Department of Ayurveda ,Bhaktivedanta Hospital and Research Institute Srishti Complex Bhaktivedanta Swami Marg Mira Road East Thane → | drvijaykumar@bhaktivedantahospital.com→ | 09320199122→ | Bhaktivedanta Hospital and Research Institute→ | Inclusion criteria: 1. COVID -19 Positive patients <br/ ><br>2. Agree to consent for the study. <br/ ><br>3. All Age groups above 18 Years <br/ ><br>4. All genders. <br/ ><br>→ | Exclusion criteria: 1. Unable to be followed-up during the trial <br/ ><br>2. Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies) . <br/ ><br>3. Any other clinical reason which may preclude entry in the opinion of the investigator. <br/ ><br>4, Pregnant Women. <br/ ><br>5. Patients who are on ventilator support . <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J22- Unspecified acute lower respiratory infection
→ | Intervention1: AYURCOV: Following study medication is for one day<br>Investigational Product Gargle 2 times a day for one day<br>Investigational Product in half glass of warm water, to drink every 2 hours, 3 times a day This need to be started 1 hour post lunch After 1 hour of completing the last dose drink 1 glass of pure bos indicus milk with two tea spoon of Go Ghrut <br>Investigational Product 2 tablets twice for one day<br><br>Control Intervention1: Standard of care treatment: COVID 19 Treatment as per government guideline.<br>→ | COVID 19 FREE DISEASETimepoint: AT TIME OF DISCHARGE→ | | 29/10/2020 | | Yes | False | | |
| → | CTRI/2020/07/026301 | 27 January 2021 | Role of Yoga in deStressing HCWs in COVID-19 : A RCT | Role of Yoga in de Stressing Health Care Personnel during COVID 19 Pandemic : A Randomised control Trial from a Tertiary Care Centre in North India | | AIIMS Rishikesh | 01-07-2020 | 20200701 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44651 | Not Recruiting | No | | | | 08-07-2020 | 60 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Bhanu Duggal→ | | Department of cardiology, AIIMS Rishikesh → | bhanuduggal2@gmail.com→ | 9084074900→ | AIIMS, Rishikesh→ | Inclusion criteria: All healthy health care personnels involved in care during COVID 19 pandemic→ | Exclusion criteria: 1. Pregnancy <br/ ><br>2. Immunocompromised <br/ ><br>3. Patients suffering from any chronic illness e.g. Heart, Lung, Liver, Kidney ailments and any chronic systemic disease. <br/ ><br>4.Musculoskeletal disease <br/ ><br>5. Individuals with acute Illness within past 01 month which is not evaluated.→ | | Intervention1: Yoga: Sukshma Vyayam -05 min<br>Yogasana-30 min<br>Deep Relaxation in Shavasana-10 min<br>Pranayam-10min<br>Dhyan -05 min<br>Intervention2: Yoga: Sukshma Vyayam -05 min<br>Yogasana-30 min<br>Deep Relaxation in Shavasana-10 min<br>Pranayam-10min<br>Dhyan -05 min<br>Intervention3: Yoga: Sukshma Vyayam -05 min<br>Yogasana-30 min<br>Deep Relaxation in Shavasana-10 min<br>Pranayam-10min<br>Dhyan -05 min<br>Intervention4: Yoga: Suksham vyayam-05 min<br>Yogasana -30 min<br>Deep Relaxation in Shavasana-10 min<br>Pranayam-10min<br><br>Total duration of study - 04 months<br>Dhyan -05 min<br>Control Intervention1: Placebo: Placebo<br>→ | Psychological measures: anxiety (GAD 7), positive and negative affect (PANAS) and trait of worry (PSWQ). <br/ ><br> <br/ ><br>Self-efficacy <br/ ><br> <br/ ><br>Team efficacy : Confidence about being able to handle the COVID-19 crisis as a team (through questionnaire) <br/ ><br> <br/ ><br>Health: General health, Mental health and Vitality <br/ ><br> <br/ ><br>Job Satisfaction <br/ ><br> <br/ ><br>Physiological measures : Heart rate variability(time and Frequency domain) and Baroreflex sensitivityTimepoint: 03 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026299 | 27 January 2021 | Impact of Corona virus pandemic and lockdown on people with mental illness and their caregivers | Impact of Covid-19 pandemic and Lockdown period on people with mental illness and their caregivers - A mixed quantitative and qualitative study | | Department of Psychiatry | 01-07-2020 | 20200701 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45163 | Recruiting | No | | | | 13-07-2020 | 804 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rajeshkrishna Bhandary P→ | | Department of Psychiatry,
Kasturba Medical College,
Madhav Nagar, Manipal → | rajesh.kbp@manipal.edu→ | 08202922217→ | Kasturba Medical College, Manipal→ | Inclusion criteria: 1. Age : 18 years and above <br/ ><br>2. Follow up patients and their Primary caregivers <br/ ><br>3. At psychiatry OPD/ IPD/ rehabilitation centre/ Camps run by the department <br/ ><br>4. Consenting for the study <br/ ><br>5. Able to read and write Kannada/ English/ Malayalam <br/ ><br> <br/ ><br>6. Those willing for additional in depth interview will go for the qualitative part of the study→ | Exclusion criteria: 1. New patients <br/ ><br>2. Unwilling to participate <br/ ><br>→ | Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
→ | | #1. Concerns regarding COVID-19, challenges during the period in terms of health, family relations, social life, work, caregiving responsibilities, coping methods, effect on the mental illness in terms of relapse, symptoms, phenomenon will be studied <br/ ><br> <br/ ><br>#2. The experience during this period will be understood through the phenomenon reported in the qualitative part of the studyTimepoint: At baseline→ | | | | Yes | False | | |
| → | CTRI/2020/07/026300 | 27 January 2021 | Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) in Healthy Volunteers | An Adaptive, Seamless Phase 1, Followed by Phase 2 Randomized, Double-blind, Multicenter Study
to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of the Whole-Virion
Inactivated SARS-CoV-2 Vaccine (BBV152) in Healthy Volunteers - BBV152 | | Bharat Biotech International Limited | 01-07-2020 | 20200701 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45184 | Not Recruiting | No | | | | 13-07-2020 | 1125 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 1/ Phase 2 | India→ | Dr V Krishna Mohan→ | | Bharat Biotech International Ltd,
Medical Affairs Department, Genome Valley, Shameerpet → | kmohan@bharatbiotech.com→ | 04023480567→ | Bharat Biotech International Limited→ | Inclusion criteria: Phase 1 <br/ ><br>1. Ability to provide written informed consent (Audio video consent for vulnerable <br/ ><br>subjects). <br/ ><br>2. Participants of either gender of age between â?¥18 to â?¤55 years. <br/ ><br>3. Good general health as determined by the discretion of investigator (vital signs (heart rate â?¥60 toâ?¤100 bpm; blood pressure systolic â?¥90 mm Hg and <140 mm <br/ ><br>Hg; diastolic â?¥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical <br/ ><br>history, and physical examination). <br/ ><br>4. Expressed interest and availability to fulfill the study requirements. <br/ ><br>5. For a female participant of child-bearing potential, planning to avoid becoming <br/ ><br>pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination <br/ ><br>6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ ><br>7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ ><br>8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination <br/ ><br>9. Agrees not to participate in another clinical trial at any time during the study period. <br/ ><br>10. Agrees to remain in the study area for the entire duration of the study. <br/ ><br>11. Willing to allow storage and future use of biological samples for future research. <br/ ><br> <br/ ><br>Phase 2: <br/ ><br>1. Ability to provide written informed consent (Audio video consent for vulnerable subjects). <br/ ><br>2. Participants of either gender of age between â?¥12 to â?¤ 65 years. <br/ ><br>3. Good general health as determined by the discretion of investigator (vital signs (heart rate â?¥60 toâ?¤100 bpm; blood pressure systolic â?¥90 mm Hg and <140 mm <br/ ><br>Hg; diastolic â?¥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination). <br/ ><br>4. Expressed interest and availability to fulfill the study requirements. <br/ ><br>5. For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study <br/ ><br>enrolment until at least four weeks after the last vaccination and agrees not to participate in another clinical trial at any time during the study period. <br/ ><br>6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ ><br>7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ ><br>8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination. <br/ ><br>9. Agrees to remain in the study area for the entire duration of the study. <br/ ><br>10. Willing to allow storage and future use of biological samples for future research. <br/ ><br>→ | Exclusion criteria: Phase 2: <br/ ><br>1. History of any other COVID-19 investigational vaccination. <br/ ><br>2. Unacceptable laboratory abnormality from screening (prior to first vaccination) <br/ ><br>or safety testing, as listed below [Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen]. <br/ ><br>(Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary <br/ ><br>care provider for follow up of these abnormal laboratory tests.) <br/ ><br>3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and/or ELISA method. <br/ ><br>4. Health care workers. <br/ ><br>5. For women, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine). <br/ ><br>6. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness <br/ ><br>such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ ><br>7. Medical problems as a result of alcohol or illicit drug use during the past 12 months. <br/ ><br>8. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period. <br/ ><br>9. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ ><br>10. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ ><br>11. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ ><br>12. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. <br/ ><br>13. Long-term use ( > 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed). <br/ ><br>14. Any history of hereditary angioedema or idiopathic angioedema. <br/ ><br>15. Any history of anaphylaxis in relation to vaccination. <br/ ><br>16. Any history of albumin-intolerance. <br/ ><br>17. Pregnancy, lactation, or willingness/intention to become pregnant during the study. <br/ ><br>18. History of any cancer. <br/ ><br>19. History of psychiatric severe conditions likely to affect participation in the study. <br/ ><br>20. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. <br/ ><br>21. Any other serious chronic illness requiring hospital specialist supervision. <br/ ><br>22. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma. <br/ ><br>23. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness <br/ ><br>24. Morbidly obese (BMIâ?¥35 kg/m2) or underweight (BMI â?¤18 kg/m2). <br/ ><br>25. Living in the same household of any COVID-19 positive person. <br/ ><br>26. Any other condition that in the opinion of the investigator would jeopardize the safety or rights → | | Intervention1: BBV152A, BBV152B and BBV152C: Whole-Virion Inactivated SARS-CoV-2 vaccine (BBV152) with three formulations, BBV152A, BBV152B and BBV152C. <br>Dose: 0.5ml, <br>Route of administration:Intramuscular injection, <br>Frequency: Two doses at Day 0 and Day 14<br>Control Intervention1: JENVAC®: JE vaccine (JENVAC®) will be used as a control. Dose:0.5ml <br>Route of administration:Intramuscular injection, <br>Frequency:Two dose at day 0 and day 14<br>Control Intervention2: Placebo: Placebo will be used as a control. <br>Dose: 0.5ml <br>Route of administration:Intramuscular injection, <br>Frequency:Two doses at Day 0 and Day 14<br>→ | Phase 1: <br/ ><br>1. The occurrence of immediate adverse events within two hours of vaccination 2. The occurrence of adverse events within 7 days of vaccination.3. The occurrence of any adverse events throughout the study duration 4. The occurrence of serious adverse events (SAEs) <br/ ><br>Phase 2: <br/ ><br>Primary <br/ ><br>1. To evaluate the immunogenicity in terms of GMT and four-fold seroconversion <br/ ><br>rate amongst the two selected BBV152 vaccine formulationsTimepoint: Phase 1: <br/ ><br>Occurrence of Adverse events within 2hrs, at Day 7 and through out the study duration <br/ ><br> <br/ ><br>Phase 2: <br/ ><br>Day 0, Day 14, Day 28, Day 42 Day 104 and Day 194 in two cohorts→ | | | | Yes | False | | |
| → | CTRI/2020/07/026298 | 27 January 2021 | The impact of COVID-19 pandemic in frontline health care professionals | An observational study to find out the impact of COVID-19 pandemic in frontline health care professionals in a COVID dedicated hospital in India | | Shri Lal Bahadur Shastri Government Medical College Hospital Mandi | 01-07-2020 | 20200701 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43722 | Not Recruiting | No | | | | 15-07-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Vatika Bhardwaj→ | | Department of Anaesthesia, SLBSGMCH, Nerchowk → | vatika.b17@gmail.com→ | 9418456233→ | Shri Lal Bahadur Sashtri Government Medical College→ | Inclusion criteria: All clinicians and health staff serving in the COVID Intensive Care Unit, Flu clinics, isolation wards, SARI wards and Operating theatre in Shri Lal Bahadur Shastri Government Medical College and Hospital, Mandi at Nerchowk a designated Covid-19 hospital in Himachal Pradesh.→ | Exclusion criteria: 1. Subjects who refuse to participate <br/ ><br>2. Subjects working in Hospital for less than 1 month as on 10th May 2020 <br/ ><br>→ | Health Condition 1: Z730- Burn-out
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: F439- Reaction to severe stress, unspecified
→ | | 1. Prevalence of burnout among health care professionals during Covid-19 in COVID dedicated hospital in rural India - Assessment of burnout risk <br/ ><br>2. Prevalence of depression risk among health care professionals during Covid-19 in COVID dedicated hospital in rural India - Assessment of depression risk <br/ ><br>Timepoint: baseline→ | | | | Yes | False | | |
| → | CTRI/2020/07/026337 | 27 January 2021 | The Covid-19 Study with Ayurveda add-on to ICMR Guideline | An Open-labeled black box clinical study to investigate efficacy of add on personalized Ayurveda intervention in comparison to standalone treatment based on ICMR guidelines in patients with COVID-19 - CSAICMR | | AVP Research Foundation | 02-07-2020 | 20200702 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44863 | Not Recruiting | No | | | | 11-07-2020 | 36 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Sujith Subash Eranezhath→ | | Head, Basic and Translational Research,
136/137, Trichy Road, Ramanathapuram P.O., Coimbatore → | cso@avpresearch.org→ | 9790502037→ | AVP Research Foundation→ | Inclusion criteria: (i) Confirmed case of COVID case with RT-PCR method at a stage when not requiring ventilator or Intensive Care Unit support (ii) Aged above 18 years willing to give informed consent. (iii) Preferably those with Diabetes Mellitus Type II as co-morbidity. (iv) X ray Chest Changes more than 20% of Lung involvement.→ | Exclusion criteria: Co-morbidities like acute and advanced stage of chronic obstructive pulmonary disease, malignancy, chronic liver diseases, recent history of cardiovascular events, renal diseases, acute inflammatory complications of diabetes like non-healing ulcers and severe neuropathy.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Add-on personalised Ayurveda intervention to ICMR Guideline on Covid-19: Observing the clinical course of COVID 19, epistemologically it fits into the algorithm of Vatakapha pradhana Sannipatta jwaram in milder cases and progressing into Vata pitta pradhana sannipatta jwara syndrome in moderate and severe cases. <br> During early stage of disease patients exhibit reduced leukocyte, lymphocyte, neutrophil count and prolonged prothrombin time due suppressed immunity but in severe cases after 5th day of onset of symptoms a gradual elevation of leukocyte, neutrophil, C-reactive protein, Ferritin, IL6, IL2, TNFα is observed due hyperinflammatory response which consolidates into ARDS requiring ICU or ventilator facility.<br>The study proposed is an attempt to clinically validated the efficacy of an add on Ayurveda intervention to limit the virulence, modulate hyperinflammatory storm and check the onset of severe ARDS requiring critical care by monitoring the above bio-markers.(1-5)<br>Mild cases would be treated with a broad spectrum jwarahara decoction with kantakari, Guduchi, Sunthi, pushkara moola and kiratthiktha (Andrographis paniculata) targeting eight type of jwara associated with kasa swasa along with gargling and prashana with madhyyasthi choornam and madhu, along with nasyam with matulunga ardraka swarasa and trilavana, administration of classical Ayurveda formulations like Indukantham Kashayam, Drakshadi Kashayam, Guduchyadi Kashayam, Vilwadi Gulika and Patolkadurohinyadi Kashyam based on personalized requirements of the patients depending upon presentation of the symptoms. Moderately severe cases would be treated with bharangyadi kashyam along with Katphala, pushkarmoola, karkatshiringi, vyosha, dusparsa, karvi made into powder and to be taken every now an→ | Primary outcome measures <br/ ><br>1. Alleviate form the symptoms of the COVID-19 <br/ ><br>2. Average stay at the hospital till PCR test becomes normal <br/ ><br>3. Reduction in the rate of mild to severe condition requiring ICU or ventilator <br/ ><br>Timepoint: Day 0 <br/ ><br>Day 3 <br/ ><br>Day 7 <br/ ><br>Day 11 <br/ ><br>Day 14→ | | 31/08/2020 | | Yes | False | | |
| → | CTRI/2020/07/026338 | 27 January 2021 | Study to assess the Health care workersâ?? knowledge of the Medical cause of death certification for COVID-19 related deaths in cancer patients | Health care professionalsâ?? awareness of the Medical cause of death certification and ICD-10 coding system for assigning COVID-19 related deaths in cancer patients | | none | 02-07-2020 | 20200702 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45181 | Not Recruiting | No | | | | 13-07-2020 | 90 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Divya Khanna→ | | Dept. of Preventive Oncology, OPD 30, OPD building, DNT BLOCK, , Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC), TATA MEMORIAL CANCER CENTRES, Varanasi 221005, India → | dkhannakgmc@gmail.com→ | 8800261044→ | Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC), TATA MEMORIAL CANCER CENTRE→ | Inclusion criteria: All clinicians of the cancer hospital who are willing to participate in the study.→ | Exclusion criteria: clinicians of the mentioned hospital who are not willing to participate in the study→ | | Intervention1: Teaching intervention based study: This will be a prospective teaching intervention based pre-test post-test study, single arm study. All eligible participants will be provided with a questionnaire related to knowledge and attitude for MCCD certification and ICD-10 coding for COVID-19 related deaths in cancer patients. <br>After the pre-test, the participants will be given a comprehensive presentation on how to do MCCD for COVID-19, especially in the scenario of cancer patents. A post-test will be performed after one week.<br><br><br>Control Intervention1: not applicable: not applicable<br>→ | To assess the awareness for correct medical cause of death certification among cliniciansTimepoint: The awareness of doctors will be re-assessed one week after the teaching intervention and will be compared with the baseline assessment.→ | | | | Yes | False | | |
| → | CTRI/2020/07/026340 | 27 January 2021 | To study the role of Zinc combined with standard treatment for COVID-19 | Prospective study to assess therapeutic role of Zinc in COVID-19 patients | | Ramen Goel | 02-07-2020 | 20200702 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44929 | Not Recruiting | No | | | | 11-07-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Case Record Numbers Blinding and masking:Participant Blinded | N/A | India→ | Ramen Goel→ | | C-10, 14th floor,
Center For Metabolic Surgery
Wockhardt Hospitals,
Agripada → | ramengoel@gmail.com→ | 9820170763→ | Wockhardt Hospitals→ | Inclusion criteria: Diagnosed with COVID-19→ | Exclusion criteria: 1. Pregnant or lactating women <br/ ><br>2. End stage CKD (chronic kidney disease) <br/ ><br>3. Patients with dementia, learning disability, mental health needs <br/ ><br>4. Unable to understand the procedures and protocol <br/ ><br>5. Deemed unfit for the study according to the investigator <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Zinc sulphate 100mg: Micronutrient Zinc combined with standard treatment <br>Tab Zinc Sulphate 100 mg OD<br>Control Intervention1: Standard treatment: Standard medications<br>→ | Reduction in symptoms <br/ ><br>Duration of stay, ICU admission, ventilator requirement, complications, dischargeTimepoint: Baseline, day 1, day 5, day 7, day 14 or till discharge→ | | | | Yes | False | | |
| → | CTRI/2020/07/026339 | 27 January 2021 | Understanding COVID and cancer | Determining the association between COVID 19 and cancer: An observational study | | Tata Memorial Centre | 02-07-2020 | 20200702 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44951 | Recruiting | No | | | | 15-07-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | C S Pramesh→ | | Director Office, Ground Floor, Main Building
Tata Memorial Hospital,
Ernest Borges Road
Parel → | cspramesh@gmail.com→ | 02224177000→ | Tata Memorial Hospital→ | Inclusion criteria: 1. All patients with a cancer diagnosis who develop COVID-19 during the period of March to August 2020. This includes all patients with a proven diagnosis of cancer at any stage of management [under evaluation, those on active treatment (curative or palliative intent) and those on follow-up (short or long-term)] <br/ ><br>2. Controls (for the impact of COVID-19 on cancer sub-study) will include retrospectively-matched patients with cancer who do not have a diagnosis of COVID. Patients will be matched for age, gender, cancer type and stage. We will include 2 groups of patients â?? concurrent (patients with cancer treated during the same time period who did not have a COVID diagnosis) and historical. <br/ ><br>3. Controls for the exploratory sub-study (cytokine and immune response in cancer patients with COVID) are health-care workers diagnosed with COVID <br/ ><br>→ | Exclusion criteria: Refusal of consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | Intervention1: nil: no intervention<br>Control Intervention1: nil: no comparator<br>→ | For the first objective (impact of a cancer diagnosis on COVID-19 outcomes), we will look at the incidence of severe COVID, morbidity (e.g., need for mechanical ventilation, renal replacement therapy) and mortality in these patients. Logistic regression analysis will help to determine associations between patient and cancer characteristics and COVID-19 outcomes.Timepoint: 28 days after COVID diagnosis→ | | | | Yes | False | | |
| → | CTRI/2020/07/026330 | 27 January 2021 | Illness Wellness Scale is a new scale which is being developed to assess the physical performance status of all patients, whether or not suffering from COVID infection, requiring surgical intervention or care. | Illness Wellness Scale: A new grading system to assess the performance status of COVID or non-COVID surgical patients during the global pandemic. | | Dr Arun Kumar | 02-07-2020 | 20200702 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45213 | Not Recruiting | No | | | | 11-07-2020 | 210 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Arun Kumar→ | | Department of Surgical Disciplines (General Surgery) Office, Room 5025, 5th Floor, Teaching block, AIIMS Hospital, Ansari Nagar, New Delhi → | dryashvant.r@gmail.com→ | 9911337726→ | All India Institute Of Medical Sciences, New Delhi→ | Inclusion criteria: Age above 16 years→ | Exclusion criteria: a) Age below 16 years <br/ ><br>b) Refusal to give consent <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To develop and validate a new grading system for assessment of performance status of surgical patients during COVID-19 pandemic.Timepoint: baseline and daily for 30 days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026331 | 27 January 2021 | Survey on Convalescent Plasma (CVP) for COVID-19 | Survey-based study on Convalescent Plasma (CVP) for COVID-19 - ConPlaS | | AIIMS | 02-07-2020 | 20200702 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45017 | Not Recruiting | No | | | | 06-07-2020 | 2200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Diptiranjan Rout→ | | Room No-13, O/o Dept. of Transfusion Medicine, 1st floor, Academic Block, NCI-AIIMS, Badsa, Jhajjar → | drdiptiranjanrout@gmail.com→ | 01251274758→ | National Cancer Institute (AIIMS), Jhajjar→ | Inclusion criteria: Not applicable→ | Exclusion criteria: Anyone aged below 18 years.→ | | Intervention1: Not applicable: Not applicable<br>Control Intervention1: Not applicable: Not applicable<br>→ | 1. To explore the knowledge, attitude, and practices of medical professionals regarding the convalescent plasma as a promising therapy for the current COVID-19 pandemic. <br/ ><br>2. To explore the knowledge, attitude of public in community regarding the convalescent plasma as a promising therapy for the current COVID-19 pandemic.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026351 | 27 January 2021 | Software for COVID19 Detection from Chest X-Ray, CT or Ultrasonography | Real-Time Artificial Intelligence based COVID detection from Chest X-Ray, Ultrasound or CT | | PurplAS IT Services Pvt Ltd | 03-07-2020 | 20200703 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45151 | Not Recruiting | No | | | | 14-07-2020 | 1000 | Observational | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Abhishek Biswas→ | | Kalinga Institute of
Medical Sciences, KIIT
University,
Bhubaneshwar → | abhishek@purpletech.in→ | 8585010011→ | PurplAS IT Services Pvt. Ltd.→ | Inclusion criteria: This study poses no additional health risk associated with standard Chest X-Ray, CT or Ultrasound procedures. <br/ ><br> <br/ ><br>The medical information that will be collected from you if you take part in this study includes: <br/ ><br> <br/ ><br>Your chest X-Ray, CT or Ultrasound Scan/Video. <br/ ><br> <br/ ><br>You may be asked to take an RT-PCR or any other COVID19 confirmatory test. <br/ ><br> <br/ ><br>Your Health data may be recorded for presence of any pre-existing diseases <br/ ><br>→ | Exclusion criteria: Patients with conditions preventing them from undergoing standard chest X-Ray, CT or Ultrasound procedures.→ | | | The entire project aims to develop a market ready Artificial Intelligence based object recognition software capable of working on Real-time live Chest Radio-Imaging data like CT Scans, Ultrasound, and X-Ray as well as integrate the same with hardware prototype(s) capable of running the software.Timepoint: 2 Sub-phases: <br/ ><br>Data Collection & Testing: 4 weeks (Sensitivity Benchmarks will be outcome) <br/ ><br>Testing & Validation: 6 weeks (replication of Outcome/Sensitivity Benchmarks of week 4 over clinical scenario) <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026343 | 27 January 2021 | Ayurvedic Rasayana treatment as an addon therapy to improve the results in management of coronavirus disease | Improving therapeutic outcomes in the treatment of mild to moderate corona virus disease in COVID 19 positive patients via oral administration of Ayurveda formulations a randomized placebo controlled multicentric study | | Ayurved Rasayani | 03-07-2020 | 20200703 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45204 | Not Recruiting | No | | | | 11-07-2020 | 200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Avinash Kadam→ | | Nande Balewadi Road
Mahalunge
Pune
→ | avinashk@rbpl.co.in→ | 9970259583→ | Ayurved Rasayani→ | Inclusion criteria: 1 Age 18 to 60 years <br/ ><br> <br/ ><br>2 COVID-19 positive as determined by PCR or other approved commercial or public health assay <br/ ><br> <br/ ><br>3 Willing and able to provide written informed consent prior to performing study procedures→ | Exclusion criteria: 1 Participation in any other clinical trial of an experimental treatment for COVID 19 <br/ ><br> <br/ ><br>2 Patients with severe COVID 19 disease defined as follows <br/ ><br> <br/ ><br>3 Respiratory distress as determined by â?¥30 breaths per min <br/ ><br> <br/ ><br>oxygen saturation at rest â?¤85% <br/ ><br> <br/ ><br>Severe disease complications e g respiratory failure requirement of mechanical ventilation, septic shock or non-respiratory organ failure <br/ ><br> <br/ ><br>4 Patients with deranged liver functions i.e Total bilirubin â?¤ 2 Liver enzymes â?¤2.5 times Under Normal limits or deranged renal functions i.e Creatinine â?¤ 1.5 times Under Normal limits <br/ ><br> <br/ ><br>5 Patients with unstable angina or history of Myocardial infarction or underwent CABG <br/ ><br> <br/ ><br>6 Patients with known diagnosis of COPD <br/ ><br> <br/ ><br>7 Pregnant women or women who are breastfeeding <br/ ><br>Immunocompromised patients or patients taking immunosuppressant medication or Patients with active malignancy Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive study treatment <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J101- Influenza due to other identifiedinfluenza virus with other respiratory manifestations
→ | Intervention1: Ayurveda therapy consisting of Pranvir Capsule and Capsule Yashada Rasayana: Pranvir capsules : 2 capsules twice daily orally with warm water.<br>Yasada capsules: 1 capsule twice daily orally with warm water<br>Control Intervention1: Placebo: Pranvir capsules placebo : 2 capsules twice daily orally with warm water. Yasada capsules placebo: 1 capsule twice daily orally with warm water<br>→ | Incidence of patients progressed to severe stage. <br/ ><br> <br/ ><br>Severe stage defined as <br/ ><br>â?¢ respiratory distress (â?¥30 breaths per min); <br/ ><br>â?¢ oxygen saturation at rest â?¤85%; <br/ ><br>â?¢ severe disease complications (eg, respiratory failure, requirement of mechanical ventilation, septic shock, or non-respiratory organ failure). <br/ ><br> <br/ ><br>Timepoint: Day 0 <br/ ><br>Till day 10→ | | | | Yes | False | | |
| → | CTRI/2020/07/026349 | 27 January 2021 | Effect of awake proning in patients with COVID-19 related respiratory failure | Effect of proning in patients with COVID-19 acute hypoxemic respiratory failure receiving non-invasive oxygen therapy: A prospective cohort study | | Anant Mohan | 03-07-2020 | 20200703 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=42918 | Recruiting | No | | | | 04-07-2020 | 20 | Interventional | Non-randomized, Placebo Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Anant Mohan→ | | Department of Pulmonary, Critical Care and Sleep Medicine, AIIMS, Delhi Delhi→ | anantmohan@yahoo.com→ | 9810048204→ | AIIMS→ | Inclusion criteria: a) All adults > 18 years of age with acute hypoxemic respiratory failure with room air saturation < 93% or PaO2/ FiO2 â?¤300 AND <br/ ><br>b) COVID -19 positive by RT- PCR or COVID-19 suspected as the most probable clinco-radiological diagnosis of acute respiratory failure <br/ ><br>→ | Exclusion criteria: 1) Age <18 yrs or >70 yrs; <br/ ><br>2) Severe ARDS P/F < 100mmHg <br/ ><br>3) PaCO2 >50 mm Hg; <br/ ><br>4) Glasgow Coma Scale <11; <br/ ><br>5) Unable to spontaneously clear secretions from the airways <br/ ><br>6) Requirement of emergency intubation for cardiopulmonary resuscitation, respiratory arrest, severe hemodynamic instability <br/ ><br>7) Refusal to receive NPPV/ HFNC/ NRBM <br/ ><br>8) Unable to cooperate with NPPV/ HFNC/ NRBM application <br/ ><br>9) Pregnancy <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | Intervention1: Prone positioning: Prone positioning for at least 30 min upto 16 hours per day till room air saturation is above 93% or till intubation<br>Control Intervention1: Supine position (as usual care): Supine position during entire ICU stay<br>→ | To study the rate of invasive mechanical ventilation in patients treated with awake proning along with non-invasive methods of oxygen delivery in patients of COVID -19 positive acute hypoxemic respiratory failureTimepoint: till discharge or intubation → | | | | Yes | False | | |
| → | CTRI/2020/07/026350 | 27 January 2021 | Stress and coping among healthcare workers during COVID-19 outbreak | Perceived stressors and coping strategies of healthcare workers during COVID-19 pandemic in a tertiary care hospital-A mixed methods study | | DrSuvarna Jyothi Kantipudi | 03-07-2020 | 20200703 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44198 | Not Recruiting | No | | | | 15-07-2020 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrSuvarna Jyothi Kantipudi→ | | Outpatient Room.no:23,Department of Psychiatry,
Sri Ramachandra Institute of Higher Education and Research,Porur,Chennai.
→ | suvarna.srmc@gmail.com→ | | Sri Ramachandra Institute of Higher Education and Research→ | Inclusion criteria: 1. Health care workers working at high risk areas during COVID-19 outbreak <br/ ><br>2. Willing to provide informed consent. <br/ ><br>→ | Exclusion criteria: 1.Not willing to provide informed consent. <br/ ><br>→ | | | To understand the nature and extent of stress among health care workers during COVID-19 pandemicTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/07/026355 | 27 January 2021 | Evaluation Of The Efficacy of AYUSH KWATH in The Prevention of COVID-19
| Evaluation Of The Efficacy of AYUSH KWATH in The prevention of COVID-19 pandemic among persons residing in hot spot area â?? An open label single arm prospective study
| | Dr SR Rajasthan Ayurved University Jodhpur | 04-07-2020 | 20200704 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45327 | Not Recruiting | No | | | | 14-07-2020 | 500 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Prof Dr Abhimanyu Kumar→ | | Office of the Vice Chancellor, Room no 101, Dr SR Rajasthan
Ayurveda University, Nagaur Road, Karwar,Jodhpur(Raj.)
Jodhpur
RAJASTHAN
342037
India
→ | vc.dsrrau@gmail.com→ | 8800543828→ | Dr. S.R. Rajasthan Ayurved University, Jodhpur→ | Inclusion criteria: All persons residing in hotspot areas of covid 19 willing to participate, with or without <br/ ><br> co- morbid condition with exposure/chance of exposure to COVID 19 positive cases. <br/ ><br>. Who are willing to provide signed informed consent <br/ ><br>→ | Exclusion criteria: 1. Pregnant females. <br/ ><br>2. Known case of Carcinoma lungs, CRF and CHF. <br/ ><br>3. Participants with any immunosuppressive medication or in an immune compromised state or hematological disease. <br/ ><br>4. Laboratory confirmed COVID-19 with or without symptoms. <br/ ><br>5. DM uncontrolled with medications. <br/ ><br>6. Any other criteria, as per the investigator would jeopardize the study. <br/ ><br>→ | | Intervention1: AYUSH KWATH: Dose : 3 gm daily mixed with 150 ml warm water<br><br>Route of Administration : Oral<br><br>Time of Administration : Once in a day- On empty stomach in the morning at least 1 hour before breakfast <br>Duration of Therapy : 07 days<br><br>Control Intervention1: not: not<br>→ | Percentage of participants with SARS- Cov-2 positivity and Number/ percentage of participants not developing any Covid-19 like sign & symptoms (Time line 07 days)Timepoint: Percentage of participants with SARS- Cov-2 positivity and Number/ percentage of participants not developing any Covid-19 like sign & symptoms (Time line 07 days)→ | | | | Yes | False | | |
| → | CTRI/2020/07/026354 | 27 January 2021 | Clinical trial of ozone therapy in mild to moderate Covid-19 subjects. | Phase I/II randomized controlled clinical trial to assess safety and efficacy of ozone therapy via rectal insufflation and minor auto haemotherapy as an adjuvant in mild to moderate Covid-19 subjects. - Nil | | Bisleri Charitable Trust | 04-07-2020 | 20200704 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45173 | Not Recruiting | No | | | | 13-07-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | Phase 1/ Phase 2 | India→ | Dr Jignasha Captain→ | | 3rd Flr, Bisleri Tower, Western Express Highway,Andheri (E) Mumbai 400 099 → | drmilishah@gmail.com→ | | Ozone Forum of India→ | Inclusion criteria: Covid 19 positive RT-PCR (nasopharyngeal swab) result <br/ ><br>Adults 30 to 60 of both sex <br/ ><br>Mild to Moderately severe disease (NEWS score Less than or equal to 8) <br/ ><br>Patients willing to provide informed consent <br/ ><br>→ | Exclusion criteria: Requiring ICU admission and or artificial ventilation at the screening <br/ ><br>Any other comorbidity which is with a critical stage at a screening <br/ ><br>Any other condition by which subject proves unfit from investigator perspective <br/ ><br>Chronic constipation for more than 7 days at the time of screening <br/ ><br>Severe stage of disease (NEWS score more than 8) <br/ ><br>Patients with G6PD deficiency <br/ ><br>Pregnant and breastfeeding women <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ozone therapy together with standard of care: Ozone therapy via rectal insufflation and minor auto haemotherapy together with standard of care daily for 10 days or negative RT-PCR for Covid 19 whichever is earlier.<br>Control Intervention1: Standard of care as per ICMR protocol for Covid 19: Standard of care daily for 10 days or negative RT-PCR for Covid 19 whichever is earlier.<br>→ | Changes in X-ray chest: interstitial pattern. <br/ ><br>Changes in hematological parameters like- blood cell counts (Absolute and differential) <br/ ><br>Changes in oxygenation index: SpO2. <br/ ><br>Changes in serum inflammation parameters like- LDH, CRP, ferritin <br/ ><br>Changes in NEWS (National Early Warning Score) <br/ ><br>Number of days for negative RT-PCR test for Covid 19Timepoint: From baseline to day 10 or negative RT-PCR for Covid 19 whichever is earlier→ | | 04/09/2020 | | Yes | False | | |
| → | CTRI/2020/07/026353 | 27 January 2021 | A study to evaluate the effect of a combination Giloy Gomutra Capsules, Asthi Churna and Kamdhenu Asava in COVID-19 | A Clinical Evaluation of the combination Giloy Gomutra Capsules, Asthi Churna and Kamdhenu Asava in the Management of the Pandemic- Covid-19. | | Bansi Gir Gaushala | 04-07-2020 | 20200704 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45266 | Not Recruiting | No | | | | 12-07-2020 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Dr Dineshchandra Pandya→ | | B-19 First Floor, District shopping centre,Sector 21
Gandhinagar
GUJARAT → | urvipandya18@gmail.com→ | 9638300839→ | Neuropanch Ayurved Hospital and Research Organization→ | Inclusion criteria: Age: >16 years <60 years. <br/ ><br>Patient having Covid-19 positive and Home quarantined patients with signs and symptoms of Covid-19.→ | Exclusion criteria: Age: <16 years and > 60 years. <br/ ><br>Pregnant women and lactating mother <br/ ><br>Severe cases of Covid-19 like associated Pneumonia, COPD, and other severe associated diseases. <br/ ><br>Patient on ventilator. <br/ ><br>Uncontrolled Diabetes Mellitus & Hypertension Any other serious systemic illness like AIDS, Malignancy etc. <br/ ><br>Patients who are not willing to be included in the study → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 1)Giloy Gaumutra Capsules 2)Asthi Churna <br>3)Kamdhenu Aasava: All the three drugs will be given to all patients , it will be single experimental group. This Ayurvedic treatment will be given for 15 days.Giloy Gaumutra Capsules 4 tds with water. Asthi Churna 5 gm with Hot water for twotimes, Kamdhenu Asava 15 ml for two times with hot water For 15 days by Oral route. <br>Control Intervention1: nil: nil<br>→ | Investigations of Covid-19 will be done before and After the treatment. Also symptoms will be given gradation and checked on before and after treatment.Timepoint: Investigations of Covid-19 will be done before and After the treatment. Also symptoms will be given gradation and checked on first, seventh and fifteenth day of the treatment.→ | | 31/07/2020 | | Yes | False | | |
| → | CTRI/2020/07/026352 | 27 January 2021 | Novel Corona Virus-2019-nCov vaccine by intradermal route in healthy subjects. | A prospective, randomized, adaptive, phase I/II clinical study to evaluate the safety and immunogenicity of Novel Corona Virus -2019-nCov vaccine candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects | | Cadila Healthcare Ltd | 04-07-2020 | 20200704 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45306 | Not Recruiting | No | | | | 13-07-2020 | 1048 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Outcome Assessor Blinded | Phase 1/ Phase 2 | India→ | Dr Ravindra Mittal→ | | Zydus Corporate Park, Scheme No. 63, Survey No. 536, Nr. Vaishnodevi Circle, S.G. Highway → | kevinkumarkansagra@zyduscadila.com→ | 02717665555→ | Cadila Healthcare Limited→ | Inclusion criteria: 1.Healthy male and non-pregnant, non-lactating female subjects between 18-55 years of age (both inclusive) <br/ ><br>2.Body weight > 50 kg for male and > 45 kg for female and BMI within the range 18.5 - 29.9 kg/m2 (Both inclusive) <br/ ><br>3.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study <br/ ><br>4.Subjects who, in the opinion of the Investigator, are healthy as determined by their pre study medical history, clinical examination, 12-lead ECG and clinical laboratory tests within the institutional normal range or judged as not clinically significant by the Investigator, including the following parameters: haematology, serum biochemistry, urinalysis, and serology <br/ ><br>5.Subjects who can comply with trial procedures and who are available for the duration of follow up <br/ ><br>6.Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after administration of last study vaccine. <br/ ><br> <br/ ><br>For Phase II:- <br/ ><br>1.Healthy subject of either gender â?¥12 years of age <br/ ><br>2.Informed consent from the adult subjects or from the parents of paediatric subjects. Additionally, assent from paediatric subjects (Audio video recording in case of vulnerable subject) <br/ ><br>3.Adult subjects or parents of paediatric subjects literate enough to fill the diary card <br/ ><br>4.Females of childbearing potential, must agree to use one of the approved contraception methods, from screening until completion of the follow-up visit and males will agree to use contraception. <br/ ><br> <br/ ><br>→ | Exclusion criteria: For Phase I <br/ ><br>1.Febrile illness (temperature â?¥ 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ ><br>2.History of confirmed SARS-CoV-2 positive <br/ ><br>3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ ><br>4.History of SARS/ MERS infection <br/ ><br>5.Subjects positive for antibody and antigen against SARS-CoV-2. <br/ ><br>6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ ><br>7.Any clinically significant laboratory or ECG findings during screening or check-in <br/ ><br>8.History or presence of significant smoking (ï?¾10 cigarettes per day) <br/ ><br>9.Systolic blood pressure more than 140 mmHg and less than 100 mmHg and diastolic blood pressure more than 90 mmHg and less than 60 mmHg. <br/ ><br>10.History of, or positive screening test for, hepatitis C infection (defined as positive for hepatitis C virus antibody), hepatitis B infection (defined as positive for hepatitis B surface antigen), or human immunodeficiency virus I or II <br/ ><br> <br/ ><br>For Phase II <br/ ><br>1.Febrile illness (temperature â?¥ 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ ><br>2.History of confirmed SARS-CoV-2 positive <br/ ><br>3.History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ ><br>4.History of SARS/ MERS infection <br/ ><br>5.Subjects positive for antibodies against SARS-CoV-2 on antibody detection test at the time of screening <br/ ><br>6.Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ ><br>7.Past history of hypersensitivity reaction or any serious adverse event after any vaccination <br/ ><br>8.Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy→ | | Intervention1: nCov Vaccine: For Phase I: 1)Dose:-0.1 ml in either of arm for Arm 1 (1 mg) with Needle and Arm 2(1 mg) with Pharmajet. In Arm 3 (2mg) with Needle and Arm 4(2mg) with Pharmajet,in both arm dose will given..(2)Frequency:-single time at day 0 day 28 and day 56.(3)Route: Intradermal. For Phase II : (1)Dose:-0.1 ml in either of arm for Arm 1 (1 mg) with Needle and Arm 2(1 mg) with Pharmajet. In Arm 3 (2mg) with Needle and Arm 4(2mg) with Pharmajet,in both arm dose will given..(2)Frequency:-single time at day 0 day 28 and day 56.(3)Route: Intradermal.<br><br>Control Intervention1: Placebo in Phase Ii: 1)Dose:-0.1 ml in either of arm for Arm 1 (1 mg) with Needle and Arm 2(1 mg) with Pharmajet. In Arm 3 (2mg) with Needle and Arm 4(2mg) with Pharmajet,in both arm dose will given.(2)Frequency:-single time at day 0, day 28 and day 56.(3)Route: Intradermal<br>→ | Phase I:-To evaluate the safety of Novel Corona Virus-2019-nCov Vaccine Candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects. <br/ ><br> <br/ ><br>Phase II:-To evaluate the immunogenicity of Novel Corona Virus-2019-nCov Vaccine Candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects compared to placebo.Timepoint: Phase I: Day 0 and Day 84 <br/ ><br>Phase II: Day 0 and Day 224→ | | | | Yes | False | | |
| → | CTRI/2020/07/026367 | 27 January 2021 | An international multi-centre appraisal of the management of acute
CHOLEcystitis during the COVID-19 pandemic: The CHOLECOVID audit. | An international multi-centre appraisal of the management of acute
CHOLEcystitis during the COVID-19 pandemic: The CHOLECOVID audit. Acronym CHOLECOVID - CHOLECOVID | | Not applicable | 05-07-2020 | 20200705 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45324 | Not Recruiting | No | | | | 15-07-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India;United Kingdom;United States of America→ | Sadiq S Sikora→ | | Room 2, Basement 1,
Institure of Digestive and Hepatopancreatobiliary Sciences,
Sakra World Hospital , 52/2 and 52/3 , Devarabeesanahalli, Varthur Hobli , Bangalore → | drsadiqs@gmail.com→ | 9900504360→ | Sakra World Hospital→ | Inclusion criteria: 1. Adult patients (greater than or including 18 years of age) <br/ ><br>2. Clinical features of acute cholecystitis including right upper quadrant pain, pyrexia and/or raised inflammatory markers (WCC, CRP) <br/ ><br>3. Documented diagnosis of acute cholecystitis as demonstrated by at least one radiological test <br/ ><br>(USS, MRCP or Computed Tomography (CT)→ | Exclusion criteria: < 18 years of age→ | Health Condition 1: K810- Acute cholecystitis
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: nil: nil<br>→ | To audit compliance to Tokyo Guidelines [3,4] (Appendix C) regarding the management of acute cholecystitis.Timepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/07/026369 | 27 January 2021 | Evaluation of the performance of rapid diagnostic kit (COVIDAG-SP) in the detection of COVID-19 virus antigen | Clinical performance validation of Recombinant Immunogenic Marker (India Health Foundation-IHFs COVIDAG-SP) based on single-chain fragment variable (scFv) specific to Spike S I & S II variable regions of SARS CoV2 for rapid detection of Antigen | | Capital Health Services India Pvt Ltd | 05-07-2020 | 20200705 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44880 | Not Recruiting | No | | | | 14-07-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr R Arunkumar→ | | Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education Kelambakkam, Old
Kancheepuram (dt), Chengalpattu DT→ | arunrmbbs1978@gmail.com→ | 9884212644→ | Chettinad Hospital and Research Institute→ | Inclusion criteria: 1. 18 Years and above <br/ ><br>2. Both males and females <br/ ><br>3. Confirmed COVID-19 positive through RT-PCR in less than 24 hours of confirmation or Symptomatic and seeking RT-PCR testing to learn their COVID-19 status→ | Exclusion criteria: 1. Cross reactive viral positive for HIV, HbsAg, NL-63, CoV1 (If suspected, they will be excluded and no serological evaluation will be applied to know the status) <br/ ><br>2. Severe co-morbidities compromising the study participation <br/ ><br>3. COVID-19 positive currently under observation/treatment after 24hrs of RT-PCR confirmatory test. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: Not Applicable as the study is for validation of diagnostic kit performance<br>Control Intervention1: NIL: Not Applicable as the study is for validation of diagnostic kit performance<br>→ | Sensitivity and Specificity of IHFs COVIDAG-SP for COVID-19 Antigen Detection against RT-PCR based DetectionTimepoint: One time→ | | | | Yes | False | | |
| → | CTRI/2020/07/026370 | 27 January 2021 | Evaluation of the performance of rapid diagnostic kit (COVIDAB-SP) in the detection of COVID-19 virus antibody | Clinical performance validation of Recombinant Immunogenic Marker (India Health Foundation-IHFs COVIDAB-SP) based on single-chain fragment variable (scFv) Antigen specific to Spike S I & S II regions of SARS CoV2 for Rapid detection of Antibody | | Capital Health Services India Pvt Ltd | 05-07-2020 | 20200705 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45185 | Not Recruiting | No | | | | 14-07-2020 | 2000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr R Arunkumar→ | | Chettinad Academy of Research and Education
Kelambakkam Old Kancheepuram (dt), Chengalpattu DT→ | arunrmbbs1978@gmail.com→ | 04447413322→ | Chettinad Hospital and Research Institute→ | Inclusion criteria: Group 1 <br/ ><br>1. Symptomatic group - confirmed RT-PCR testing, admitted and treated in isolation wards that are declared good-to-discharge by a RT-PCR retest or Clinician judgment. <br/ ><br>Group 2 <br/ ><br>1. Asymptomatic group from â??Positive-linkedâ?? like relatives or contactable connects of infected and tested positive. <br/ ><br>2. Healthcare Workers / relatives of RT PCR positives <br/ ><br>Group 3 <br/ ><br>1. Asymptomatic group with no links or contractable connects of infected (Random) <br/ ><br>Group 4 <br/ ><br>1. Negative PCR <br/ ><br>2. Co-morbidities risk such as Diabetes mellitus, hypertension and other chronic cardiac, liver, neurological and kidney ailments <br/ ><br>→ | Exclusion criteria: 1. Symptomatic COVID-19 positive patients -within2 weeks of confirmatory RT-PCR <br/ ><br>2. Symptomatic people with high fever, dry cough and respiratory distress <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Not Applicable as the study is for validation of diagnostic kit performance<br>Control Intervention1: Nil: Not Applicable as the study is for validation of diagnostic kit performance<br>→ | 1. Evaluation of the consistency ofâ??Positive COVIDAB-SPâ?? for â??Positive PCRâ?? and Consistent â??Negative COVIDAB-SPâ?? for â??Negative PCRâ?? <br/ ><br>2. Change in status of asymptomatic as a result of multiple testing involving antigens (RT PCR) and COVIDAB-SP for antibody detectionTimepoint: one time→ | | | | Yes | False | | |
| → | CTRI/2020/07/026368 | 27 January 2021 | Spread of corona virus disease and factors affecting it in Pune city. | Secondary attack rate of Covid-19 during pandemic in Pune City, Maharashtra
| | NIL | 05-07-2020 | 20200705 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45232 | Not Recruiting | No | | | | 13-07-2020 | 700 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Dr Ganesh Jagdale→ | | Department of community medicine BJGMC Pune Department of community medicine BJGMC Pune→ | drparandemalan@gmail.com→ | 9850131337→ | BJ GOVT MEDICAL COLLEGE & SASSOON GENERAL HOSPITAL PUNE→ | Inclusion criteria: All the contacts laboratory confirmed Covid 19 cases will be enrolled after taking informed consent.In case study subject is less than 18 years , informed consent will be taken from the parents/guardian and the assent will be taken from the subject.→ | Exclusion criteria: All contacts of laboratory confirmed Covid 19 cases from area outside Pune city.→ | | | Secondary attack rate of COVID-19 among the contacts during the pandemicTimepoint: 1 month→ | | | | Yes | False | | |
| → | CTRI/2020/07/026371 | 27 January 2021 | Kabasura Kudineer, Shakti drops and Turmeric plus in the management of COVID-19 | A clinical study to evaluate the effect of AYUSH medicines in the management of COVID-19 | | Sriveda Sattva Private Limited Sri Sri Tattva | 05-07-2020 | 20200705 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45272 | Not Recruiting | No | | | | 13-07-2020 | 30 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Dr M Ravi Kumar Reddy→ | | Research and Development Block , Room No 1
Sriveda Sattva Pvt Ltd 54/56 39th A Cross 11th Main Road 4th
T Block Jayanagar Bangalore Karnataka India 560041
Bangalore
KARNATAKA → | rrpulmo@gmail.com→ | | Mazumder Shaw Medical Centre Narayana Hrudayalaya, Bangalore→ | Inclusion criteria: 1. Age limit â?? 20 to 55 years, both Male &Female <br/ ><br>2. Uncomplicated cases of COVID19 patients on Allopathic medication of stage 1 and stage 2 <br/ ><br>3. Patients whom ventilator support is not required <br/ ><br>4. Patients with no associated comorbidities <br/ ><br>5.patientswillingtogivetheirconsenttoparticipateintheclinicaltrial→ | Exclusion criteria: 1. COVID-19 positive patients above 55 years of age & below 20years <br/ ><br>2. Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes or chronic or acute renal failure or pre -existing cardiac conditions. <br/ ><br>3. Patients on immuno-suppression therapy <br/ ><br>4. Pregnant Women or lactating mothers→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 1.Kabasura kudineer<br>2.Shakti Drops<br>3.Turmeric plus tablets: 1.Kabasura kudineer 2 tablets taken thrice a day before food<br>2.Shakti Drops â?? 6 drops with 100 ml of water thrice a day before food<br>3.Turmeric plus tablets â?? 2 tablets thrice a day after food<br>Control Intervention1: only ongoing allopathic medicines: only ongoing allopathic medicines<br>→ | Early recovery in the signs and symptoms of cases of stage 1 and stage 2 of COVID-19 by adding Ayurvedic medicines which are effective in fever, symptoms of respiratory tract and by enhancing immunity of body by adding Rasayana drugsTimepoint: 1,14,21 and 28 the day→ | | | | Yes | False | | |
| → | CTRI/2020/07/026389 | 27 January 2021 | Effect of Corona virus infection and lockdown on access to health services and on mental health among urban and peri-urban low- to mid-socioeconomic neighborhoods in South Delhi | Effect of COVID19 pandemic and lockdown on utilization of essential health services, quality of life and psychosocial impact in urban and peri-urban low- to mid-socioeconomic neighborhoods in South Delhi | | Centre for Health Research and Development Society for Applied Studies | 06-07-2020 | 20200706 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44395 | Recruiting | No | | | | 01-08-2020 | 450 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sarmila Mazumder→ | | Centre for Health Research and Development, Society for Applied Studies 45 Kalu Sarai, New Delhi 110016, India
→ | bireshwar.sinha@sas.org.in→ | 46043751-55→ | Centre for Health Research and Development, Society for Applied Studies→ | Inclusion criteria: Women who have delivered recently, women with under-twos, married women aged 15-49 years, adolescent girls→ | Exclusion criteria: Non consent for participation→ | | | - Antenatal care prior to and during lockdown period <br/ ><br>- Intra-natal care prior to and during lockdown period <br/ ><br>- Childhood immunization prior to and during lockdown periodTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026424 | 27 January 2021 | An Observational Study on Health issues during covid 19 lock down | An Observational Study on Health issues
Developed during Lock down w.s.r. Physical fitness challenges
| | DrSR Rajasthan Ayurved university jodhpur | 08-07-2020 | 20200708 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45337 | Not Recruiting | No | | | | 14-07-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Rahul Parashar→ | | room no. 118
Dept. of Kaya chikitsa
University college of Ayurveda
Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur
Jodhpur
RAJASTHAN
342037
India → | vc.dsrrau@gmail.com→ | 8800543828→ | Dr.S.R. Rajasthan Ayurved university jodhpur→ | Inclusion criteria: 1. All respondents age will be 15 to 75 years who follows the rules and guidelines of Lock down. <br/ ><br>2. Respondents who are aware of health issues. <br/ ><br>3. Persons who are willing to participate. <br/ ><br>→ | Exclusion criteria: 1. Respondents with traveling history in the city and out the city area. <br/ ><br>2. Respondents of emergency services. <br/ ><br>3. Patients with COVID-19 in critical condition. <br/ ><br>→ | | | To identify the health issues developed during Lock down at Jodhpur city area.Timepoint: 35 days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026431 | 27 January 2021 | A clinical trial to find out the effectiveness of traditional awareness method and anticipatory guidance through motivational interviewing. | Effectiveness of awareness programme in mothers on prevention of early childhood caries during covid 19 pandemic in sullia - a randomized control trial | | KVG Dental College Hospital | 08-07-2020 | 20200708 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45340 | Not Recruiting | No | | | | 01-09-2020 | 700 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Outcome Assessor Blinded | Phase 1/ Phase 2 | India→ | Dr Allwin Antony→ | | Department of Pedodontics & preventive Dentistry
3rd Floor, Room no: 6
KVG Dental College& Hospital
kurunjibhag p o
sullia
DK → | drsavithaks123@gmail.com→ | 7975047946→ | KVG Dental College and Hospital→ | Inclusion criteria: 1) Mother accompanied by children less than 2 years old <br/ ><br>2) Mother child pairs who are willing to participate <br/ ><br>3) Mother child pairs who are willing to informed consent. <br/ ><br>→ | Exclusion criteria: 1) Child having major systemic diseases, such as bleed disorder, cardiac disorder or renal disorder; <br/ ><br>2) Children who are on long-term medication such as antiepileptic drugs. <br/ ><br>3) Children with oral soft tissue lesion/s, history of allergy to the constituents of fluoride gel, systemic illness and those requiring extensive rehabilitation <br/ ><br>4) Mother & child pair who have/had fever or any symptoms of fever <br/ ><br>5) Mother & child pair who have/had recent travel history <br/ ><br>→ | | Intervention1: ONLINE GROUP: The mother & child pairs who fall randomly into online group will be allocated by a stratified randomisation method at the subject level using a personal computer into the following two groups; group 1 (Traditional awareness group) and group 2 (Awareness using with motivational interviewing & anticipatory guidance). There will be no negative control group for ethical consideration. The group 1 will undertake awareness by presentation, videos & posters after consent. The group 2 will then undertake awareness through counselling sessions (last up to 30 minutes) done within 4 weeks after consent with one additional counselling sessions and the study participant has to face-to-face or phone contact, after first 6 months for review). Evaluation of the implemented awareness session will be done using questionnaires, nyvad index, dmft/def index & caries risk assessment tool.<br>Control Intervention1: OFFLINE GROUP: The mother & child pairs who fall under offline group will be allocated using a stratified randomisation method at the subject level with a personal computer into the following two groups; group 1 (Traditional awareness group) and group 2 (Awareness using with motivational interviewing & anticipatory guidance). The group 1 will undertake awareness by presentation, videos & posters after consent. The group 2 will then undertake awareness through counselling sessions (last up to 30 minutes) done within 4 weeks after consent with one additional counselling sessions and the study participant has to face-to-face or phone contact, after first 6 months for review. Evaluation of the implemented awareness session will be done using questionnaires, nyvad index, dmft/def index & caries risk assessment tool.<br>→ | The primary outcome measure will check the effectiveness of awareness by reversal of white spot lesions on the anterior teeth examined using nyvad index and caries risk assessment tool. Incidence of dental decay measured at 6, 12, 18 and 24 months of age using dmft/def index and at 24 months by criteria specified by WHO.Timepoint: Reversal of white spot lesion by awareness Incidence of dental decay Caries risk assessment 24 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026433 | 27 January 2021 | Effect of Ayurveda medicinein Covid-19 mild symptoms | Evaluation of Efficacy of an Ayurved Management as a Supportive Therapy in SARS - CoV-2 Mild Positive patients- An Open Labeled Randomized Active Control Trial | | Ayush Govt of Gujarat | 08-07-2020 | 20200708 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45252 | Not Recruiting | No | | | | 15-07-2020 | 25 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Vd Shital G Bhagiya→ | | Room No. 20, Department of Panchakarma, Govt. Akhandanand Ayurved College, Ahmedabad.
→ | drdilipjn@gmail.com→ | 9925941861→ | Govt. Ayurved College→ | Inclusion criteria: Patients with mild symptoms of COVID 19 positive patients by RT-PCR <br/ ><br>Patients who can take oral medicine. <br/ ><br>patients who can give informed consent→ | Exclusion criteria: Age less then 18 and more then 60 years. <br/ ><br>Patients having severe symptoms of COVID 19 <br/ ><br>Patients on mechanical ventilator or ECMO <br/ ><br>Patients who cannot take oral medicine <br/ ><br>Pregnant and lactating women <br/ ><br>CVA, oncological diseases and other systemic uncontrol conditions <br/ ><br>Liver and/or kidney malfunctions. <br/ ><br>Severe Pneumonia, Acute Respiratory Distress Syndrome, Sepsis and Septic Shock. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 1 Dashamula Kwatha and<br>Pathyadi Kwatha with Trikatu Churna<br>2 Sansamani Vati<br>3 AYUSH 64 <br>4 Yastimadhu Ghanavati: 1 Dashamula Kwatha 20 ml with Pathyadi Kwatha 20 ml with Trikatu Churna 2 gm in Decoction form twice a day on empty stomach <br>2 Sansamani Vati 500 mg Two Tab twice a day After meal<br>3 AYUSH 64 Tablet Two Tab twice a day After meal <br>4 Yastimadhu Ghanavati chewable tablet 500 mg 1 Tab Six times a day Every two hourly in day time<br>Control Intervention1: Tab Azithromycin 500<br>Tab Pantoprazole<br>Tab Vit C<br>Tab PCM 1 tab sos: 1 Tab Azithromycin 500 1 time After Meal for 5 days<br>2 Tab Pantoprazole 1 time Before Meal for 5 days<br>3 Tab Vit C 2 times a day for 28 days<br>4 Tab PCM 1 tab SOS<br>→ | 1 Clinical improvement (as per WHO / Ayurvedic scale) <br/ ><br>2 Time duration required for negative COVID test or symptom free stage <br/ ><br>Timepoint: 0 day, 3rd day, 7th day, 14th day, 28th day or till Negative report of RT-PCR→ | | 09/10/2020 | | Yes | False | | |
| → | CTRI/2020/07/026463 | 27 January 2021 | Clinical study to evaluate efficacy and safety of GanjhuVir syrup and tablet in Covid-19 positive patients. | A Randomized, Open Label, Single Centre, Observational, Prospective, Clinical Study to Evaluate the Efficacy and Safety of GanjhuVir syrup and tablet when administered along with Standard of Care (SOC) and compared against SOC in Covid-19 positive patients. | | Radhika Ayurveda Research and Development | 09-07-2020 | 20200709 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43844 | Recruiting | No | | | | 10-07-2020 | 15 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | N/A | India→ | Dr Rajesh Kumar Ganjhu→ | | Radhika Ayurveda Research and Development, RH No.03 Survey No. 1 -1-1 Laxmi Nagar, Pimple Gurav, Pune -411061, Maharashtra, India→ | rajeshganjhu@gmail.com→ | | Radhika Ayurveda Research and Development→ | Inclusion criteria: 1. Male or female volunteers aged between 18 to 65 years both inclusive. <br/ ><br>2. Ready to give informed volunteer consent. <br/ ><br>3. Respiratory Syndrome caused by Corona virus infection confirmed by polymerase chain reaction (PCR) test /any other confirmatory tests. <br/ ><br>4. Patient who require hospitalization. <br/ ><br>5. Diabetic patients with sugar levels in normal limits. <br/ ><br>6. Females must be using an effective contraception method or other form of birth control prior to and during the study and use will continue till EOS. <br/ ><br>7. Males will ensure that their female partners of childbearing potential will utilize an effective contraceptive method or other form of birth control to avoid pregnancy. <br/ ><br>→ | Exclusion criteria: 1.Previously treated with antiviral therapy, systemic steroids or immunosuppressant within 2 weeks prior to study Day1. <br/ ><br>2. Participation in any other clinical trial of an experimental treatment for Covid-19 or any other clinical trial of different indication. <br/ ><br>3. Hospitalization in ICU. <br/ ><br>4. Evidence of multiorgan failure, suspected latent tuberculosis infection <br/ ><br>5. Requiring mechanical ventilation at screening. <br/ ><br>6. Any known severe allergic/ hypersensitivity to GanjhuVir syrup or tablet. <br/ ><br>7. Patients with chronic kidney disease, cardiac anomaly, receiving cancer therapy, HIV positive or Hepatitis positive. <br/ ><br>8. Females who are pregnant (positive urine or serum pregnancy test at screening evaluation) or lactating. <br/ ><br>9. Presence of any pre-existing illness that, in the opinion of the investigator, would place the subject at an unreasonably increased risk through participation in thisstudy. <br/ ><br>10. Participation in another trial with an investigational drug within 1 month prior to this trial. <br/ ><br>11. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ganjhuvir Syrup: 10 ml Ganjhuvir syrup will be administered 3 times a day, 1 hr before meal, along with SOC for 10 days<br>Intervention2: Ganjhuvir Tablet: 1 Ganjhuvir Tablet will be administered 3 times a day, 1hr before meal, along with SCO for 10 days.<br>Control Intervention1: Standard of Care treatment: As prescribed and as recomended<br>→ | 1. Reduction in Covid -19 viral load on day 5 and day10. <br/ ><br>2. Improvement in symptoms like cough, sore throat, fever, inflammation and shortness <br/ ><br>of breath from baseline to 5 and day10 <br/ ><br>3. Changes in platelet, WBC count and C- Reactive Protein from baseline to day 5, and up <br/ ><br>to10 <br/ ><br>4. Number of patients requiring oxygen therapy at the end of the treatment[10 day] <br/ ><br>5. Temperature measurement twice daily at armpit [9 AM and 9PM] <br/ ><br>7Duration of hospitalization: From randomization up to day10. <br/ ><br>Timepoint: Efficacy Assessments from day 0 to day10→ | | | | Yes | False | | |
| → | CTRI/2020/07/026462 | 27 January 2021 | A study to observe and assess the safety and efficacy of Unani regimen in preventing the progression of severity of asymptomatic mild to moderate symptomatic cases. | A prospective, interventional, case control study to observe and assess the safety and efficacy of Unani regimen in preventing the progression of severity of the disease in hospitalized SARS-CoV2 tested positive asymptomatic /mild to moderate symptomatic COVID-19 cases, managed as per Govt of India COVID-19 management guidelines, at a COVID-19 management facility | | Central Council for Research in Unani Medicine CCRUM New Delhi | 09-07-2020 | 20200709 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44637 | Not Recruiting | No | | | | 20-07-2020 | 124 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Nauman Saleem→ | | Department of Ilmul Saidla, A and U Tibbiya college, Karol Bagh → | usamakramdr@gmail.com→ | 9540606010→ | Central Council for Research in Unani Medicine (CCRUM)→ | Inclusion criteria: 1. Patients of either sex aged between 18-65 years <br/ ><br>2. Patients who have been tested positive with SARS-CoV2 virus <br/ ><br>Asymptomatic Patients <br/ ><br>or <br/ ><br>Patients with mild symptoms <br/ ><br>or <br/ ><br>Patients with moderate symptoms with respiratory rate < 30 per minute and oxygen <br/ ><br>saturation > 90% <br/ ><br>3. Voluntariness to participate in the trial <br/ ><br>USCDC classification mild to moderate, severe and critical stages of COVID-19 <br/ ><br>Stage Features <br/ ><br>Asymptomatic No specific clinical symptoms of COVID-19 disease <br/ ><br>Mild to Moderate Mild clinical symptoms up to mild pneumonia <br/ ><br>Severe Dyspnea, hypoxia, or >50% lung involvement on imaging <br/ ><br>Critical Respiratory failure, shock, or multiorgan system dysfunction→ | Exclusion criteria: The subject must be excluded from participating in the trial if they fulfill anyone of the criteria as <br/ ><br>mentioned below: <br/ ><br>1. COVID-19 patients with symptoms classified as severe or critical. <br/ ><br>2. Suspected COVID-19, not tested positive for COVID-19 by RT-PCR <br/ ><br>3. Persons with severe primary respiratory disease or pneumonia <br/ ><br>4. Pregnant and lactating women <br/ ><br>5. Persons with serious diseases such as Cancer, Heart Disease, Stroke, Disabilities, Mental <br/ ><br>illnesses, etc., and who are considered to be excluded from the study as evaluated by the <br/ ><br>investigators <br/ ><br>6. COVID-19 positive cases participating as subjects in the interventional arm of other <br/ ><br>COVID-19 clinical trials→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Khameera Marvareed: 5 g once daily, Orally for 14 days along with the standard care of treatment as recommended by MOHFW guidelines for COVID-19 patient care<br>Intervention2: Unani Joshanda/ Decoction: Lukewarm once daily, for 14 days along with the standard care of treatment as recommended by MOHFW guidelines for COVID-19 patient care<br>Intervention3: Conventional treatment: Conventional treatment<br>Control Intervention1: NIL: NIL<br>→ | Time taken to get COVID-19 RT-PCR test negative. <br/ ><br>Incidence of patients progressing to next stage with regards to severityTimepoint: 14 days→ | | 12/09/2020 | | Yes | False | | |
| → | CTRI/2020/07/026445 | 27 January 2021 | Types of dental emergencies during Covid epidemic | Local dental emergencies during Covid epidemic â?? survey among practicing dentists | | Tina Purayil | 09-07-2020 | 20200709 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45445 | Not Recruiting | No | | | | 18-07-2020 | 380 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Tina Purayil→ | | Room number 2, Department of Conservative Dentistry and Endodontics, Manipal College of Dental Sciences, Manipal → | tina_p_p@yahoo.com→ | 9448332741→ | Manipal Academy of Higher Education→ | Inclusion criteria: Dentists willing to participate→ | Exclusion criteria: Non-practicing dentists→ | | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | Common types of dental emergencies due to dental conditions or treatment related <br/ ><br>Strategies to resolveTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/07/026451 | 27 January 2021 | Observational Study of Sensitivity and Specificity of COVID-19 Screening and
Diagnostics in COVID-19 Infected Individuals.
| Development of an Isothermal PCR assay as an apt screening tool for Covid-19 (Bionest incubatee)
| | InnoDx Solutions Pvt Ltd | 09-07-2020 | 20200709 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44483 | Not Recruiting | No | | | | 13-07-2020 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sandeep Verma→ | | InnoDx Solutions Pvt Ltd
Lab no.5 Cabin no.3,
BSC BioNEST Bio-Incubator (BBB),
Regional Centre for Biotechnology (RCB),
3rd milestone, Faridabad-Gurgaon Expressway,
Faridabad - 121001 → | sci.m@inno-dx.com→ | | InnoDx Solutions Pvt Ltd→ | Inclusion criteria: 1) All patients whose RT-PCR for COVID-19 is positive with high load (with good amplification curve and Ct value range from 10 to 25), will be included in this study as COVID cases. <br/ ><br>2) All patients whose RT-PCR for COVID-19 is negative (Ct value is undetermined), will be included in this study as COVID negative cases. <br/ ><br>→ | Exclusion criteria: 1) All the patients whose RT-PCR result is inconclusive (amplification curve not seen but giving Ct value) will not be included in this study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Not Applicable: Not Applicable<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | Development cost-effective COVID-LAMP assay kitTimepoint: 7 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026471 | 27 January 2021 | A clinical trial to study the effect and safety of the Siddha medicines in patients with Corona Virus disease | A prospective, non-randomized, single-arm interventional study to assess the safety and efficacy of Siddha Sasthric Medicines â?? Fixed Regimen in the prevention of COVID-19 disease progression of asymptomatic, and mild at Siddha COVID Care Centre, Chennai, 2020 (SSM-FiRe) - SSM-FiRe | | The Directorate of Indian Medicine and Homoeopathy | 10-07-2020 | 20200710 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45318 | Not Recruiting | No | | | | 20-07-2020 | 60 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Dr D Sasikumar→ | | Research & Development Wing
Directorate of Indian Medicine and Homoeopathy, Arumbakkam, Chennai → | siddha2k6@gmail.com→ | 9443579540→ | Siddha Central Research Institute→ | Inclusion criteria: COVID -19 Positive as determined by RT-PCR or other approved commercial or public health assay <br/ ><br>Willing to provide written/digital informed consent. <br/ ><br>COVID - 19 Positive with no clinical signs <br/ ><br>COVID - 19 Positive with mild symptoms â?? Fever, Cough, Sneezing, Sore Throat, Throat Pain, Malaise, Tiredness <br/ ><br>→ | Exclusion criteria: Pregnant and lactating females <br/ ><br>COVID - 19 Positive with Severe symptoms â?? Respiratory distress ( >24 breath per minute), Oxygen saturation <90% at rest, Respiratory failure, Need of Mechanical Ventilation, Septic shock, Non-respiratory organ failure <br/ ><br>Chronic Renal Failure requiring dialysis (eGFR < 30) <br/ ><br>Known cases of uncontrolled Diabetes ( >10% HbA1c) <br/ ><br>Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>Subjects having immune-compromised status like HIV, Hepatitis, Tuberculosis, Cancer, etc. <br/ ><br>Participants taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>Participants having a past history of allergy to Siddha medicine. <br/ ><br>Participants with Hb - <7 g/dL→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Kaba Sura Kudineer: 60ml BD for 14 days<br>Intervention2: Tab. Amukkarachooranam: 2 BD for 14 days<br>Intervention3: Tab. Athimathuram: 2 BD for 14 Days<br>Intervention4: Tab. Brahmanandha Bairavam: 100mg 1BD for 14 days<br>Intervention5: Adathodai Manappagu: 10ml with 30ml water BD for 14 days<br>Intervention6: Thippili Rasayanam: 5gm BD for 14 days<br>Intervention7: Notchi Kudineer: 60ml BD for 14 Days<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | Reduction in incidence of clinical symptoms of COVID-19 or Negative conversion of SARS-CoV-2Timepoint: 14 Days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026469 | 27 January 2021 | Rapid diagnostic test for the detection of COVID-19 antibodies | Validation of a rapid diagnostic test for the detection of COVID-19 antibodies | | HealthCubed India Pvt Ltd | 10-07-2020 | 20200710 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45336 | Not Recruiting | No | | | | 14-07-2020 | 100 | PMS | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Post Marketing Surveillance | India→ | Dr Monila Patel→ | | Smt.NHL Municpal Medical College
Pritan Rai Cross Road, Ellise Bridge, Paldi, Ahmedabad, Gujarat 380006 → | monilapatel@hotmail.com→ | | Department of Medicine→ | Inclusion criteria: Negative SARS-CoV-2 subjects: <br/ ><br>Aged 18 years of age or over <br/ ><br> Negative SARS-CoV-2 result by RT-PCR <br/ ><br> Positive SARS-CoV-2 subjects: <br/ ><br>Aged 18 years of age or over <br/ ><br> Positive SARS-CoV-2 result by RT-PCR <br/ ><br> Requires hospitalisation <br/ ><br>10 days post onset of symptoms→ | Exclusion criteria: Negative SARS-CoV-2: <br/ ><br>â?¢ Aged less than 18 years <br/ ><br>â?¢ Outpatients <br/ ><br>â?¢ History of known immune suppression <br/ ><br>â?¢ Participation in any other trial <br/ ><br>Positive SARS-CoV-2: <br/ ><br>â?¢ Aged less than 18 years <br/ ><br>â?¢ Patients unlikely to survive >28 days in view of attending medical team <br/ ><br>â?¢ Outpatients <br/ ><br>â?¢ Anticipated transfer to another hospital within 72 hours <br/ ><br>â?¢ History of known immune suppression <br/ ><br>â?¢ Less than 10 days since the onset of symptoms <br/ ><br>â?¢ Participation in any other trial→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | 1.No lines - invalid Test <br/ ><br>2.Control line Visible - Negative <br/ ><br>3.Control lINE and IgM or IgG and IgG lines visible - PositiveTimepoint: 13 weeks→ | | 18/07/2020 | | Yes | False | | |
| → | CTRI/2020/07/026468 | 27 January 2021 | Drug Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients
| A Randomized, Open Label, Parallel Efficacy, Active Control, Multi- Centre Exploratory Drug Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation III [Yashtimadhu] as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients | | AYUSHCSIR | 10-07-2020 | 20200710 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44844 | Recruiting | No | | | | 18-09-2020 | 140 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Case Record Numbers Blinding and masking:Investigator Blinded | N/A | India→ | Mr Chandu Devanpally→ | | Office: 318, Next to Frankfin, Level-3, Connaught Place,
Bund Garden Road, Pune-411001, MH, India.→ | dmmondhe@iiim.ac.in→ | | Indian Institute of Integrative Medicine (Council of Scientific & Industrial Research)→ | Inclusion criteria: i) Typical clinical presentation of acute onset febrile illness with cough and a RT_PCR based laboratory confirmation test for COVID-19. The patients may have other symptoms such as fever (patients with episodes of fever up to 48 hrs. and constant fever reading will be considered), myalgia, headache, diarrhoea and tastelessness suggestive of COVID-19. <br/ ><br>ii. Patients with mild to â??moderate diseasePatients must agree not to share medication <br/ ><br>iii. Patients willing to participate and sign an informed consent→ | Exclusion criteria: i. Patients suffering from severe COVID-19 Disease as judged by a physician <br/ ><br>ii. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study <br/ ><br>iii. History of immunosuppression: solid organ or bone marrow transplant, use of immunosuppressive antimetabolic and biologic agents, intrinsic immunodeficiencies, HIV infection. <br/ ><br>iv. Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. <br/ ><br>v. Atleast one fever episode every 24 hours for > 72h <br/ ><br>vi. Patients on parenteral nutrition <br/ ><br>vii. Patients with known sensitivity or contraindication to any of the ingredients of study medication <br/ ><br>viii. History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.) <br/ ><br>ix. Patients who are likely to worsen or planned ICU admission or ventilator support due to any reason <br/ ><br>x. Pregnancy and lactation <br/ ><br>xi. Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19 <br/ ><br>xii. Participation in any other clinical trial of an experimental agent treatment for COVID-19 <br/ ><br>xiii. Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind. <br/ ><br>xiv. Physician decision that involvement in the study is not in the patient´s best interest→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Formulation 3 and SOC: Yashtimadhu, 300 mg, 2 tablets ,2 times a day for 12 weeks along with standard of care.<br>Control Intervention1: Only Standard of Care Treatment: As per Hospital protocol<br>→ | a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery (see criteria below)] <br/ ><br>b) Proportion of patients showing clinical recoveryTimepoint: From baseline up to 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/07/026470 | 27 January 2021 | Safety and Effectiveness of Siddha Sastric Medicines for the Management of Covid-19 | A prospective, non-randomised, single arm observational study to access the safety and effectiveness of Siddha Sastric Medicines â?? Fixed Regimen intervention in prevention of COVID-19 disease progression of severity from COVID-19 Positive asymptomatic, mild or moderate to critical with reference to the Siddha guidelines of COVID-19 management, Ministry of AYUSH, Govt. of India at a Home Quarantine Chennai Containment Zone | | Almaa Siddha Multispeciality Hospital Pvt Ltd | 10-07-2020 | 20200710 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45363 | Not Recruiting | No | | | | 15-07-2020 | 200 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Dr V THANIGAVELAN→ | | Almaa Siddha Multispeciality Hospital Pvt. Ltd
No 10, Pillaiyar Koil Street, Saidapet, Chennai
→ | pitchiahkumar@yahoo.com→ | | State Licensing Authority (IM)→ | Inclusion criteria: 1. COVID -19 Positive as determined by RT-PCR or other approved commercial or public health assay <br/ ><br>2. Willing to provide written/digital informed consent. <br/ ><br>3.COVID - 19 Positive with no clinical signs <br/ ><br>4.COVID - 19 Positive with mild symptoms â?? Sneezing, Cough, Sore Throat, Throat Pain, Malaise, Tiredness, Fever <br/ ><br>5.COVID - 19 Positive with moderate symptoms â?? Fever with cough, breathlessness but respiratory rate <24 per minute and Oxygen saturation more than 94% at rest <br/ ><br>→ | Exclusion criteria: 1. Pregnant and Lactating females <br/ ><br>2. COVID - 19 Positive with Severe symptoms â?? Respiratory distress ( >24 breath per minute), Oxygen saturation less than 94% at rest, Respiratory failure, Need of Mechanical Ventilation, Septic shock, Non respiratory organ failure <br/ ><br>3. Chronic Renal Failure requiring dialysis (eGFR < 30) <br/ ><br>4. Known cases of uncontrolled Diabetes ( >9% HbA1c) <br/ ><br>5. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>6. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>7. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>8. Subjects participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>9. Subjects having a past history of allergy to any medicine that is part of the Siddha intervention. <br/ ><br>10. Subjects with bleeding disorders and severe anaemia(Hb - <7 g/dL) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Siddha Medicines in fixed regimen: Kaba Sura Kudineer Chooranam â?? Decoction â?? Two times daily before 30 min of meals for 14 days, <br><br>Adathodai Manapagu â?? 10 ml â?? Three times daily after meals for 14 days,<br><br>Thaleesadhi Chooranam Mathirai 500 mg â?? 2 tablet - Four times daily after meals for 14 days,<br><br>Brammhanandha bairavam 100 mg â?? 1 pill - Two times daily after meals for 7 days when fever does not subside for 7 days after administering above three medicines. This Brammhanandha bairavam 100 mg pill will not be administered initially for first 7 days. <br><br>Control Intervention1: Not Applicable: No treatment<br>→ | 1.RT-PCR will be the gold standard used to assess sero conversion - Positive to negative which is the main outcome of this study. This will be used to establish the effect of the intervention. <br/ ><br> <br/ ><br>To support this, reduction in the severity of disease and reductions of symptoms will be documented. <br/ ><br> <br/ ><br>2.Reduction in severity of the disease will be measured using Immune Status Questionnaire (ISQ). <br/ ><br> <br/ ><br>3.Reductions of symptoms will be documented using case report form <br/ ><br>Timepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026472 | 27 January 2021 | Epidemiology and outcomes of COVID-19 in Udupi | Clinical and epidemiological study of COVID-19 patients in Udupi | | Kasturba Medical College Manipal | 10-07-2020 | 20200710 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45392 | Not Recruiting | No | | | | 16-07-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Kavitha Saravu→ | | Department of Infectious Diseases
Kasturba Medical College, Madhav Nagar, Manipal → | kavitha.saravu@manipal.edu→ | 9448107636→ | Kasturba Medical College, Manipal Academy of Higher education, Manipal→ | Inclusion criteria: Medical records of admitted COVID-19 patients above the age of 18 years diagnosed by molecular tests (RT PCR or True Nat)admitted at DR T M A Pai Hospital and Kasturba Hospital between February 2020 to January 2021→ | Exclusion criteria: a)Non availability of the medical records. <br/ ><br>b)Biological materials required (type - blood, tissue etc and quantity): Not applicable as it is a medical chart review. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Severity proportionTimepoint: Baseline, 7 days, 14 days during hospitalization/Until discharge→ | | | | Yes | False | | |
| → | CTRI/2020/07/026499 | 27 January 2021 | Evaluation of the performance of India Health Foundationâ??s (IHFâ??s) RT PCR kit for detection of COVID-19 virus (SARS-CoV-2) antigens | Clinical performance validation of India Health Foundationâ??s (IHFâ??s) RT PCR kit for detection of E gene, RdRP gene and Spike gene specific to COVID-19 virus (SARS-CoV-2) in the Naso Pharyngeal swab | | Capital Health Services India Pvt Ltd | 10-07-2020 | 20200710 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45406 | Not Recruiting | No | | | | 20-07-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr R Arunkumar→ | | Room No. 2, Dept. of Pharmacology, Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education, Kelambakkam Old Kancheepuram (dt), Chengalpattu DT→ | arunrmbbs1978@gmail.com→ | 04447413322→ | Chettinad Hospital and Research Institute→ | Inclusion criteria: All NP samples that tested positive and negative in RT PCR assay will be made anonymous and included in the study before disposal→ | Exclusion criteria: Left over sample is not adequate for the RT PCR assay→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | Sensitivity & Specificity of IHFâ??s RT PCR kit for COVID-19 Detection against any other standard RT-PCR based DetectionTimepoint: Baseline (one time)→ | | | | Yes | False | | |
| → | CTRI/2020/07/026473 | 27 January 2021 | Views of Indian dental students on international dental higher education after Covid-19 | Perception of Indian dental students on seeking international dental higher education post Covid-19 pandemic. | | P Kalyana Chakravarthy | 10-07-2020 | 20200710 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45448 | Not Recruiting | No | | | | 18-07-2020 | 400 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Niharika→ | | Room n-1509, block B, New international hostel, MAHE, Manipal → | drkalyan81@gmail.com→ | 9916036303→ | Manipal Academy of Higher Education→ | Inclusion criteria: Final year dental students, interns and students who recently finished graduation and who are willing to participate will be included→ | Exclusion criteria: Dental students who donâ??t wish to pursue dentistry overseas→ | | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | Perception of dental students towards pursuing dental education overseas post-Covid 19Timepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/07/026474 | 27 January 2021 | Effect of insulins (a chemical in our body which decreases blood sugar) sugar lowering effect in COVID-19 patients | Association between baseline insulin resistance and hospital mortality in moderate to severe
non- diabetic COVID-19 patients: An Observational Study | | Dr Souvik Maitra | 10-07-2020 | 20200710 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45474 | Not Recruiting | No | | | | 19-07-2020 | 125 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | Dr Souvik Maitra→ | | Room No: 5011, Teaching Block
Department of Anaesthesiology, Pain Medicine & Critical Care
All India Institute of Medical Sciences, Ansari Nagar → | souvikmaitra@live.com→ | 08146727891→ | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: Adult patients (aged between 18 to 80y), fulfilling WHO case definition of COVID-19 infection and moderate to severe or critically ill will be included in this study.→ | Exclusion criteria: 1. Patientsâ?? refusal <br/ ><br>2. Mild COVID-19 infection. <br/ ><br>3. Unproven COVID-19 infection. <br/ ><br>4. Patients with known diabetes mellitus as per ADA 2010 criteria <br/ ><br>5. Patients on steroids <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | To know whether Insulin Resistance measured by HOMA Insulin Resistance (IR) score can predict in-hospital mortalityTimepoint: Till hospital discharge→ | | | | Yes | False | | |
| → | CTRI/2020/07/026510 | 27 January 2021 | Clinical presentation, Management, Treatment and Outcome of COVID patients | Clinical presentation, Treatment and Outcomes of COVID patients admitted at a Multi-specialty hospital in Chennai - COVID Registry. | | Hindu Mission Hospital | 12-07-2020 | 20200712 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45415 | Not Recruiting | No | | | | 17-07-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr D K Sriram→ | | Room No:54 Diabetology Clinic,
Hindu Mission Hospital, No:103 GST Road, West Tambaram,Chennai.
→ | melvingeorge2003@gmail.com→ | 9894133697→ | Hindu Mission Hospital→ | Inclusion criteria: All hospitalized patients with COVID-19. <br/ ><br>Patients of any age groups (Child, Adult, and older adult) of either gender including minors and pregnant womens. <br/ ><br>Patients receiving any specific treatment for COVID-19 disease <br/ ><br>→ | Exclusion criteria: Suspected patients with COVID-19, not confirmed by the laboratory. <br/ ><br>Patients who refused to receive medical treatments. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Clinical ImprovementTimepoint: 2 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/07/026509 | 27 January 2021 | Serosurvey for antibodies against SARS-CoV-2 in Pune city | Epidemiological and Serological Surveillance of COVID-19 in Pune | | Persisten Foundation | 12-07-2020 | 20200712 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45476 | Not Recruiting | No | | | | 20-07-2020 | 1520 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | L S Shashidhara→ | | Biology, IISER Pune
Dr. Homi Bhabha Road
Pune
→ | aurnab@iiserpune.ac.in→ | | Indian Institute of Science Education and Research Pune→ | Inclusion criteria: Adults above the age of 18 will be recruited.→ | Exclusion criteria: COVID positive patients and critically ill will be excluded.→ | | | Estimate of seroprevalence of antibodies against SARS-CoV-2.Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026508 | 27 January 2021 | Genome Sequencing of COVID-19 virus | Genome Sequencing of SARS-CoV2 Virus from Clinical Samples | | Dr Manoj Kumar Bhat Director NCCS Pune | 12-07-2020 | 20200712 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44266 | Not Recruiting | No | | | | 20-07-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Rajesh Karyakarte→ | | Department of Microbiology BJ Government Medical College Pune Jai Prakash Narayan Road Railway Station Road Pune 411001→ | karyakarte@hotmail.com→ | 9922402502→ | BJ Medical College, Pune→ | Inclusion criteria: Samples that have tested positive for SARSCoV2 by RT qPCR→ | Exclusion criteria: Samples that have tested negative for SARSCoV2 by RT qPCR→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J969- Respiratory failure, unspecified
→ | | RNA Genomic Sequence Data of SARS-CoV2 from the selected samplesTimepoint: 1 One month after commencement of study <br/ ><br>2 Six month after commencement of study <br/ ><br>3 One year month after commencement of study that is at the End of study→ | | | | Yes | False | | |
| → | CTRI/2020/07/026514 | 27 January 2021 | Randomized Controlled Trial Of Resveretrol-Copper OR Sodium-Copper-Chlorophyllin Versus Standard Treatment In Severe Covid-19 Cancer Patients. | A Phase-II, Open Label, Randomized Controlled Trial of Resveretrol-Copper Plus Standard Treatment Or Sodium-Copper-Chlorophyllin Plus Standard Treatment Versus Standard Treatment in Cancer patients with SARS-CoV-2 Infection who are Symptomatic Or have Pneumonia for Covid 19. | | Tata Memorial Centre | 13-07-2020 | 20200713 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45580 | Not Recruiting | No | | | | 22-07-2020 | 200 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2 | India→ | VIKRAM GOTA→ | | Room No.102,Khanolkar Shidhika,
Department of Clinical Pharmacology,
ACTREC,Sector No.22,Kharghar, Navi Mumbai → | vikramgota@gmail.com→ | 7715019117→ | ACTREC, Tata Memorial Centre→ | Inclusion criteria: 1.Male and non-pregnant female patients 18 years of age or older. <br/ ><br>2.Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen. <br/ ><br>3.Pneumonia confirmed by chest imaging <br/ ><br>3.Oxygen saturation (Sao2) of 94% or less while they were breathing ambient air <br/ ><br>4.Either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 3 (CTCAE Version 5.0) 5.Abnormalities in any of these parameters. <br/ ><br>6.Patients with high blood sugar or glycosylated haemoglobin, of any degree will be eligible. <br/ ><br>7.Arterial blood gas, if done, could have abnormal values of pH, PO2, PCO2 and bicarbonate levels. <br/ ><br>→ | Exclusion criteria: Asymptomatic or only mildly symptomatic→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Resveratrol-Copper tablets: Patients will be administered orally, tablets of R-Cu containing 5.6 mg of Resveratrol and 560 ng of copper, 1 tablet once every 6 hours, from the date of randomization till the day of discharge, or death, whichever is earlier. They will also receive the Standard Treatment<br>Intervention2: Chlorophyllin tablets: Patients will be administered orally, tablets of chlorophyllin, 1 tablet of 750 mg once every day, on empty stomach in the morning, from the date of randomization till the day of discharge, or death, whichever is earlier. They will also receive the Standard Treatment .<br>Control Intervention1: Standard treatment: Patients in this arm can receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs. However, patients in this arm cannot receive Resveratrol -Copper treatment. The treatment proptocol will be in sync with the emerging scientific evidence and evolving national guidelines<br>→ | The time to clinical improvement, defined as a 2-point improvement on a 7-point ordinal scale will be the primary endpoint.Timepoint: 10 Days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026515 | 27 January 2021 | Randomized Controlled Trial Of Resveretrol-Copper Or Sodium-Copper-Chlorophyllin Vs Standard Treatment In Mild Covid-19 infection with Cancer Patients. | A Phase-III, Open Label, Randomized Controlled Trial of Resveretrol-Copper Plus Standard Treatment Or Sodium-Copper-Chlorophyllin Plus Standard Treatment Versus Standard Treatment in Cancer patients with SARS-CoV-2 Infection who are Asymptomatic Or Mildly Symptomatic for Covid 19. | | Tata Memorial Centre | 13-07-2020 | 20200713 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45584 | Not Recruiting | No | | | | 22-07-2020 | 300 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3 | India→ | VIKRAM GOTA→ | | Room No. 102,Khanolkar Shodhika,ACTREC-TMC,Sector No.22,Kharghar,Navi Mumbai → | vikramgota@gmail.com→ | 7715019117→ | ACTREC, Tata Memorial Centre→ | Inclusion criteria: 1.Male and non-pregnant female cancer patients 18 years of age or older. <br/ ><br>2. Positive reverse-transcriptaseâ??polymerase polymerase chain-reaction (RT-PCR) in a diagnostic specimen <br/ ><br>3. Either asymptomatic or have only mild symptoms ((cough and/or fever and/or sore throat and/or other upper respiratory symptoms) at the time of study inclusion <br/ ><br>4.Oxygen saturation of >94% while breathing ambient air, if this is measured <br/ ><br>5.Either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. <br/ ><br>6. Patients with high blood sugar or glycosylated haemoglobin, of any degree will be eligible <br/ ><br>7. Arterial blood gas, if done, should have normal values of pH, PO2, PCO2 and bicarbonate level.→ | Exclusion criteria: 1.Cancer diagnosis not proven <br/ ><br>2. Have pneumonia confirmed by chest imaging, 3. Have oxygen saturation (Sao2) of 94% or less while they were breathing ambient air <br/ ><br>4.Have any Grade 2 or worse laboratory abnormality, including haematological, renal, liver, electrolyes. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Resveratrol-Copper tablets: Patients will receive Resveratrol-Copper tablets (1 tablet 4 times per day) from the date of randomization to the day of discharge or death, whichever is earlier. Patients in this arm can also receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs.<br>Intervention2: Chlorophyllin tablets: Patients will receive oral Chlorophyllin tablets daily under fasting conditions at a dose of 750 mg OD from the date of randomization to the day of discharge or death, whichever is earlier. Patients in this arm can also receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs.<br>Control Intervention1: Standard treatment: Patients in this arm can receive all standard treatment that the treating team considers appropriate including any other antibiotic, antibacterial, antiviral or antimicrobial drugs.<br>→ | the proportion of patients who suffer clinical deterioration OR viral persistence at Day 10 from the date of randomization (excluding the date of randomization).Timepoint: 10 Days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026532 | 27 January 2021 | Comparison to two different position to relieve difficulty in breathing in COVID- 19 patients | Awake Prone Position Versus Repeated Position Change in Moderate to Severe COVID-19 patients: A Pilot Randomized Controlled Trial | | Dr Souvik Maitra | 13-07-2020 | 20200713 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44354 | Not Recruiting | No | | | | 14-07-2020 | 90 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Dr Souvik Maitra→ | | Room No: 5011, Teaching Block
AIIMS, Ansari Nagar, New Delhi → | souvikmaitra@live.com→ | 08146727891→ | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: Adult patients (aged between 18 and 75y) with laboratory confirmed diagnosis of COVID-19 pneumonia, presenting with self-reported symptom of shortness of breath will be included in this trial after informed written consent→ | Exclusion criteria: Patients who refuse to participate, hemodynamically unstable patients, pregnant patients and patients requiring mechanical ventilation will be excluded from this study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Repeated Position Change: One hour right lateral, two hours prone and one hour left lateral<br>Control Intervention1: Awake Prone Positioning: Awake Prone Positioning for 4h in patients presented with shortness of breath<br>→ | To compare repeated positioning with 4h continuous prone positioning in terms of self-reported dyspnea in a 10- point visual analogue scaleTimepoint: 4hour since randomization→ | | | | Yes | False | | |
| → | CTRI/2020/07/026534 | 27 January 2021 | Study of antiviral nutraceutical PICOVRID in COVID 19 patients | Evaluation of clinical efficacy of antiviral nutraceutical PICOVRID in COVID-19 positive patients | | Indian Institute of Technology Bombay | 13-07-2020 | 20200713 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45137 | Not Recruiting | No | | | | 20-07-2020 | 70 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | Dr Rinti Banerjee→ | | Dept of Biosciences and Bioengineering, 503 Nanomedicine Lab, Indian Institute of Technology Bombay → | rintibanerjee@gmail.com→ | 98196322131→ | Indian Institute of Technology,Bombay.→ | Inclusion criteria: 1. Individuals COVID-19 positive in last 3 days <br/ ><br>2. Patients with mild COVID-19 illness as defined in the MOHFW guidelines i.e. fever and or upper respiratory tract infection ,influenza like illness <br/ ><br>3. Patients agreeing to provide a written informed consent <br/ ><br>4. Patients who agree to reside in the COVID 19 facility during the study→ | Exclusion criteria: 1. Patients with moderate or severe COVID 19 at the time of recruitment <br/ ><br>2. Patients not able to consume drugs orally <br/ ><br>3. Patients with uncontrolled hypertension or diabetes mellitus <br/ ><br>4. Patients with decompensated liver disease or renal disease <br/ ><br>5. Pregnancy or lactation <br/ ><br>6. Patients with multiorgan failure <br/ ><br>7. Patients undergoing home quarantine during treatment of mild or very mild COVID 19 <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: PICOVRID syrup along with standard care: PICOVRID syrup 10 ml once a day along with standard care for 14 days<br>Control Intervention1: Standard care: Standard care for 14 days<br>→ | 1.Reduction of viral load , indicated by increase in cycle threshold in nasopharyngeal and throat swabs by RT PCR on day 5, 7, 14 as compared to on admission <br/ ><br>2.Time taken for clinical cure defined as <br/ ><br>Normalization of pyrexia and body pain <br/ ><br> Respiratory rate less than 24 per minute <br/ ><br>SpO2 rate more than 94 percent <br/ ><br>Relief from cough <br/ ><br>Relief from anosmia, for a period of 72 hour <br/ ><br>3.Proportion of patients with swabs negative for SARS-nCOV on day 5, 7 <br/ ><br>Timepoint: Day 5, 7, 14.→ | | | | Yes | False | | |
| → | CTRI/2020/07/026533 | 27 January 2021 | Study to observe cancer directed treatment during COVID-19 pandemic situation. | Observational study of patients receiving cancer-directed systemic therapy during the COVID-19 pandemic | | Not Applicable | 13-07-2020 | 20200713 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45172 | Not Recruiting | No | | | | 19-07-2020 | 10000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Kumar Prabhash→ | | Tata Memorial Centre,Homi Bhabha Block,2nd floor,Room no.204 Dr.Ernest Borges road Parel, Mumbai → | kprabhash1@gmail.com→ | 02224177214→ | TATA MEMORIAL CENTRE→ | Inclusion criteria: 1.Patient with a diagnosis of malignancy (all types), or who are being worked up for a suspected diagnosis of malignancy. <br/ ><br>2. Patient being evaluated in the Department of Medical Oncology and Pediatric Oncology. <br/ ><br>3. All patients planned for or receiving systemic therapy in the OPD, ward, daycareand ICU will be eligible. <br/ ><br>4. Patients who are on routine follow-up without active treatment will also be eligible.→ | Exclusion criteria: NONE→ | Health Condition 1: C00-D49- Neoplasms
→ | Intervention1: Not Applicable as observational study: Not Applicable as observational study<br>Control Intervention1: Not Applicable as observational study: Not Applicable as observational study<br>→ | To describe the patient demographics, treatment patterns and outcomes of patients planned for or receiving systemic cancer-directed therapy in the department of MedicalOncology and Pediatric Oncology at Tata Memorial Center, in various settings including the outpatient department (OPD), wards, daycare and ICU.Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026529 | 27 January 2021 | A Study to evaluate the safety and efficacy of Eflornithine against the standard of care in human adult hospitalized COVID-19 patients | An open label, randomized, three treatment, three arm, parallel group, investigator initiated, comparative clinical trial to evaluate the safety and efficacy of Eflornithine against the standard of care in human adult hospitalized COVID-19 patients | | Dr Abhay Vispute Shantaram | 13-07-2020 | 20200713 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45475 | Not Recruiting | No | | | | 20-07-2020 | 18 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Abhay Vispute Shantaram→ | | SRV Hospital Dr Mandakini Parihar Marg
opposite Lokmanya Tilak Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra → | drasv@rediffmail.com→ | 9819428656→ | Dept. of Medicine, SRV Hospital→ | Inclusion criteria: 1. Has laboratory-confirmed positive COVID-19 infection as determined by RT-PCR or other commercial or public health assay in any specimen, an RT-PCR (Nasopharynx and Throat) test shall be repeated to assess eligibility. <br/ ><br>2. Symptomatic male or non-pregnant female adult requiring hospitalization, with or without comorbidities between the age group of 18-85 years of age at time of enrollment. <br/ ><br>3. Illness or condition of any duration, and at least one of the following: <br/ ><br> - Fever defined as temperature greater than or equal to 36.6C (98.4F) measured by an infrared body temperature detection device. <br/ ><br> - Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR <br/ ><br> - Clinical assessment (evidence of rales/crackles on exam) AND SpO2 less than or equal to 94% on room air, OR <br/ ><br> - Requiring supplemental oxygen, OR <br/ ><br> - Requiring mechanical ventilation. <br/ ><br>4. Women of childbearing potential must agree to either abstain or use at <br/ ><br>least one primary form of contraception not including hormonal contraception from the time of screening to the end of study (Day 28 or live hospital discharge, whichever is earlier). <br/ ><br>5. Agrees to not participate in another clinical trial for the treatment of COVID-19 until the end of study (Day 28 or live hospital discharge, whichever is earlier). <br/ ><br>6. Subject (or legally authorized representative) providing written informed consent prior to initiation of any study procedures. <br/ ><br>7. Has a personal (mobile/cellular) phone, and is able to nominate at least one locator individual (e.g. a family member, friend or recovery mentor) with a verifiable address and a telephone number to assist with the arrangement of follow-up appointments as required. <br/ ><br>→ | Exclusion criteria: 1. Testing positive for HIV, HbsAg and HCV infection. <br/ ><br>2. Females who are currently pregnant or breastfeeding. <br/ ><br>3. Allergy or other contraindication to one of the investigational products. <br/ ><br>4. Has received Eflornithine within the last 10 days. <br/ ><br>5. Has received anti-viral, anti-malarial or anti-bacterial within the last 14 <br/ ><br>days. <br/ ><br>6. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) <br/ ><br> > 5 X upper limit of normal (ULN). <br/ ><br>7. QTc interval â?¥ 500ms. <br/ ><br>8. Recent Myocardial Infarction (within last 6 months). <br/ ><br>9. Known case of (K/C/O) Congestive heart failure. <br/ ><br>10. K/C/O Chronic Kidney Disease. <br/ ><br>11. K/C/O active Tuberculosis. <br/ ><br>12. History of drug or alcohol dependence in the past 6 months. <br/ ><br>13. In the opinion of the clinical team, progression to death is imminent and <br/ ><br>inevitable within the next 24 hours, irrespective of the provision of <br/ ><br>treatments. <br/ ><br>14. Anticipated transfer to another hospital which is not a study site within <br/ ><br>72 hours. <br/ ><br>15. K/C/O of epilepsy.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B998- Other infectious disease
→ | Intervention1: Eflornithine: Treatment arm 1: Dose 2.5g, Oral solution administered every 6 hours + Standard of Care (SoC) excluding antimalarials and antivirals<br>Treatment arm 2: Dose 5.0, oral solution administered every 6 hours + Standard of Care (SoC) excluding antimalarials and antivirals.<br>Control Intervention1: Standard Of Care (SoC): SoC including antimalarials, antivirals and macrolides.<br>→ | Time to Negative Viral Test: will be assessed by the time taken from initiation of the study treatment (i.e. the first study dose) to the day when the RT-PCR test results are first shown to be negative from samples collected from all of the below: <br/ ><br>a) Nasopharynx <br/ ><br>b) Throat <br/ ><br>An ICMR approved RT-PCR test resulting negative in the first instance, will be reconfirmed â?¥ 24 hours apart with fresh samples from the same sites (a) Nasopharynx and (b) Throat.Timepoint: 1, 4, 7, 14, 21 and 28 days <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026516 | 27 January 2021 | Clinical manifestations in neonates born to Covid 19 positive mothers. | Clinical manifestations and outcome in neonates born to covid-19 positive mothers- An observational prospective cohort study | | Dr Sukena Susnerwala | 13-07-2020 | 20200713 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44982 | Not Recruiting | No | | | | 25-07-2020 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sukena Susnerwala→ | | Ward 25,
Department of Neonatology
2nd floor casualty building
Government Medical College,Aurangabad
431001 → | deshmukhls@yahoo.com→ | 9822478275→ | Government Medical College,Aurangabad→ | Inclusion criteria: All neonates born to mothers with RT-PCR confirmed covid 19 infection.→ | Exclusion criteria: Neonates born to suspect mothers with symptoms consistent with Covid 19 but negative RT-PCR.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | An analysis of the varied clinical manifestations in neonates born to covid 19 positive nothersTimepoint: At birth, 24 hours of life and day 14 of life→ | | | | Yes | False | | |
| → | CTRI/2020/07/026528 | 27 January 2021 | Herbal formulation for immunity boosting during pandemic | Open label single center prospective study to assess the efficacy of herbal formulation for immunity boosting during COVID-19 pandemic - AVHF | | Aparna Abhay Raut | 13-07-2020 | 20200713 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45269 | Not Recruiting | No | | | | 13-08-2020 | 500 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shailaja Prakash Chondikar→ | | 22, Saubhagya Estate, Takali Road, Near Tigraniya Compund, Dwaraka Nashik Kamal nagar Hirawadi Nashik→ | shailajachondikar@gmail.com→ | 9730866968→ | Shree Saptashrungi Ayurved Mahavidyalaya and Hospital→ | Inclusion criteria: 1.Subject willing to give voluntary informed consent <br/ ><br>2. Irrespective Sex <br/ ><br>3. Healthy Volunteers <br/ ><br>4. Health Workers <br/ ><br>5. Front line workers during pandemic <br/ ><br>6. Subject having travelling history <br/ ><br>7. Subject willing to follow the procedure as per the study protocol <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. COVID 19 positive patient <br/ ><br>2. Fever <br/ ><br>3. Hypersensitivity or idiosyncratic reaction to any drugs or herbal products <br/ ><br>4. History of allergic condition <br/ ><br>5. History of psychiatric disorder <br/ ><br>6. Presence of abnormal laboratory report <br/ ><br>7. Known subject of malignancy <br/ ><br>8. Subject of participating in another clinical study→ | | Intervention1: Herbal Formulation: Guduchi<br>Ashwagandha<br>Tulasi<br>Haridra<br>Sunthi<br>Maricha<br>Pimpali<br>Twak<br>Kirattikta<br>Bhumyalaki<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | 1-Number of individuals developing symptoms <br/ ><br>2-Number of individuals turning COVID 19 test positiveTimepoint: 0-enrollment of patient for <br/ ><br> intervention(baseline) <br/ ><br>Follow up after 2 weeks. <br/ ><br>Outcome will be assessed <br/ ><br>1-Baseline- <br/ ><br>2nd-after 4 week <br/ ><br>3rd - after 6 week <br/ ><br>4th-after 8 week <br/ ><br>5th -after 10 week <br/ ><br>6th- after 12 week→ | | | | Yes | False | | |
| → | CTRI/2020/07/026530 | 27 January 2021 | Ayurvedic formulations for the prevention of COVID-19 infection | A multi-centric, open labelled, double-arm, phase II/III interventional study to evaluate the efficacy of composite Ayurvedic formulations for treatment of COVID-19 infections | | SASTRA Deemed University | 13-07-2020 | 20200713 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45532 | Not Recruiting | No | | | | 01-08-2020 | 200 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr S Swaminathan→ | | ASK-1, Lab No. 409, Department of Bioengineering, Centre for Nanotechnology & Advanced Biomaterials,
SASTRA Deemed University,
Thanjavur 613401,
Tamil Nadu, India,
→ | drsms72@gmail.com→ | 919790000666→ | Kamakshi Ayurvedha Vaidyasala→ | Inclusion criteria: i. Males and females between 18 and 70 years of age will be informed of the nature of the study and informed written consent will be obtained <br/ ><br>ii. COVID positive patients in the hospitals and home quarantine patients <br/ ><br>iii. Laboratory confirmed COVID 19 with or without symptoms but NOT with active illness (ventilator support) <br/ ><br>iv. Body weights within 25% of the appropriate weight range <br/ ><br>v. Twelve lead ECG without significant abnormalities <br/ ><br>→ | Exclusion criteria: i. Persons already treated with any of the study drugs during the last 30 days <br/ ><br>ii. Pregnant and lactating females and those who have a pregnancy plan <br/ ><br>iii. Known allergy to any of the medications used in this trial <br/ ><br>iv. Any disease or condition, which might compromise the haematopoietic, renal, liver, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal system <br/ ><br>v. History of allergic conditions â?? asthma, urticaria, eczema <br/ ><br>vi. History of autoimmune disorders â?? lupus erythematosis (SLE) <br/ ><br>vii. History of alcohol addiction <br/ ><br>viii. History or presence of dyspepsia, gastric ulcer or duodenal ulcer <br/ ><br>ix. History of psychiatric disorders <br/ ><br>x. Presence of clinically significant abnormal laboratory results during screening. Use of any recreational drugs or a history of drug addiction <br/ ><br>xi. Subjects with HIV, HBV and HCV <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: As standard treatment suggested by WHO/ICMR (treatment period of 14 days): As standard treatment suggested by WHO/ICMR for Covid-19 patients for a treatment period of 14 days<br>Control Intervention1: Standard treatment suggested by WHO/ICMR (allopathic anti-viral drugs) (treatment period of 14 days) and will be supplemented with ayurvedic formulations consisting of Arishtam, Churnam and Kashayam: Amirtharishtam â?? 5 mL <br>Dasamoolarishtam - 5 mL <br>Kanakasavam â?? 5 mL<br>Vasarishta â?? 5 mL<br>Total â?? 20 mL <br>The 20 mL Arishtam will be diluted in 30 mL of hot water before being administered orally<br><br>Ashwagandha â?? 1 g<br>Karpuradi Churnam -1 g <br>Sithopaladi - 1 g <br>Yashtimadhu - 1 g <br>Sudarsana - 1 g <br>Guduchi Sattva - 1 g<br>Total â?? 6 g<br>The 6 grams Churnam will be administered orally in honey<br><br><br>Indukantham Kashayam â?? 15 mL<br>This will be diluted in 30 mL of hot water before administration<br><br>(for 14 days â?? twice a day before meals)<br>→ | Episodes and severity of symptoms of respiratory tract infection (cold, sore throat, dry cough, breathlessness) in subjects who may get direct or indirect exposure to COVID 19Timepoint: After enrollment on day one, clinical assessments will be done on day 3, 6, 9 and 12 and 14→ | | | | Yes | False | | |
| → | CTRI/2020/07/026535 | 27 January 2021 | A clinical study to observe the effects of 8.4% Sodium Bicarbonate impregnated steam inhalation on Covid-19 infected patients | A randomized open label parallel group trial to study the safety and efficacy of steam impregnated with 8.4 % Sodium Bicarbonate in patients with Covid-19 infection | | Dr Bharat S Mody | 13-07-2020 | 20200713 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45535 | Not Recruiting | No | | | | 20-07-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label | N/A | India→ | Dr Kshitij B Mody→ | | Welcare Hospital,
Near Mercedes Showroom,
Atladara-Vadsar Ring Road, Atladara, Vadodara. → | joints.mody@gmail.com→ | | Welcare Hospital→ | Inclusion criteria: Males and Females of age 18 years or more diagnosed with Covid-19 infection by RT-PCR test method and not on Invasive Ventilatory Support. <br/ ><br> <br/ ><br>Subject willing to give written consent (Volunteer Information Sheet and Informed Consent Form) prior to enrolment in the study. <br/ ><br> <br/ ><br>Subjects must have clinically acceptable results for all the screening parameters.→ | Exclusion criteria: Males and Females not proven to have Covid-19 infection by a positive RT-PCR test result. <br/ ><br> <br/ ><br>Males and Females having proven Covid-19 infection by positive RT-PCR test result but on Invasive Ventilatory Support. <br/ ><br> <br/ ><br>Subject deemed uncooperative or noncompliant.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Sodium Bicarbonate 8.4% Impregnated Steam Inhalation: 50 ml of 8.4% Sodium Bicarbonate through a naso-oral<br>delivery apparatus attached to an electric steam generating apparatus. Frequency would be twice daily separated by 8 hours for 5 days, 5 minutes per session.<br>→ | Reduction in laboratory values of the following inflammatory markers: ESR, CRP, Serum Ferritin, Serum Procalcitonin, Serum Lactate Dehydrogenase (LDH), and IL6 and improvement in clinical parameters. <br/ ><br> <br/ ><br>Reduction in laboratory values of the following coagulopathy marker: D Dimer <br/ ><br> <br/ ><br>Improvement in Clinical Parameters.Timepoint: 5 days→ | | 31/08/2020 | | Yes | False | | |
| → | CTRI/2020/07/026576 | 27 January 2021 | Influence of Lockdown on dental professionals | Impact of COVID-19 Lockdown among Dental Professionals | | Dr Swathi Pai | 14-07-2020 | 20200714 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45573 | Not Recruiting | No | | | | 25-07-2020 | 400 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Swathi Pai→ | | Department of Conservative Dentistry and Endodontics
MCODS Manipal
Manipal Academy of Higher Education → | swathi.pai@manipal.edu→ | 9739463771→ | Manipal College of Dental Sciences Manipal→ | Inclusion criteria: Indian Dentists who are practicing dentistry→ | Exclusion criteria: Non dentists <br/ ><br>Non practicing dentists→ | | Intervention1: NIL: NIL<br>→ | The dental professionals will be benefitted in case there is any observation found in terms of the psychological effects of the lockdown. Further, some measures can be taken accordingly to prevent untoward instances.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026560 | 27 January 2021 | Neem Prophylaxis for Subjects Coming in Contact with COVID-19 Patients | Prophylaxis with Neem Capsules (Azadirachta indica) in Healthcare personnel and relatives in Contact with COVID-19 Patients | | Nisarga Biotech Pvt Ltd | 14-07-2020 | 20200714 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45385 | Not Recruiting | No | | | | 21-07-2020 | 200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Double Blind Double Dummy | Phase 3 | India→ | Dr Mohini Barde→ | | RH-05, PS Villa, Manjari, Pune-28 → | drmohinib@gmail.com→ | | Med Indite Communications Pvt Ltd→ | Inclusion criteria: 1. Subjects will be healthcare personnel (physicians, nurses, chemists, pharmacists, stretcher-bearer, administrative and respiratory therapists) who works in healthcare facility or other well characterized high-risk environment. OR Relative of a patient with COVID-19 infection in a participating hospital <br/ ><br>2. Males and females of 18-60 years of age. <br/ ><br>3. Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals. <br/ ><br>4. Not previously diagnosed with COVID-19. <br/ ><br>5. Not currently symptomatic with an Acute Respiratory Infection. <br/ ><br>6. Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use contraceptive methods. <br/ ><br>7. Ability to swallow and retain oral medication. <br/ ><br>8. Willingness and ability to comply with trial and follow-up procedures. <br/ ><br>9. Ability to understand the nature of the trial and give written informed consent. <br/ ><br>→ | Exclusion criteria: 1. Known hypersensitivity to neem products. <br/ ><br>2. Subjects on other prophylactic medications. <br/ ><br>3. Age <18 years old. <br/ ><br>4. Suspected or confirmed current COVID-19, defined as: temperature > 38 Celsius; cough; shortness of breath; sore throat; or, if available (not required), positive confirmatory testing for COVID-19. <br/ ><br>5. Suspected or confirmed convalescent COVID-19, defined as any of the above symptoms within the prior 4 weeks. <br/ ><br>6. Subjects who is on angiotensin-converting enzyme (ACE) inhibitor. <br/ ><br>7. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol. <br/ ><br>8. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. <br/ ><br>→ | | Intervention1: Neem capsule 50 mg: Neem capsule 50 mg twice a day for 28 days.<br>Control Intervention1: Neem capsule 50 mg BID: Neem capsules 50 mg will be self-administered twice daily with water.<br>Control Intervention2: Matching Placebo: Placebo capsule 50 mg twice a day for 28 days.<br>→ | Number of symptomatic cases of COVID-19 infectionTimepoint: Within 56 days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026574 | 27 January 2021 | To assess the seriousness in COVID-19 patients with the blood test report.
| Neutrophil-lymphocyte ratio and Platelet to lymphocyte ratio as markers for predicting the severity in COVID-19 patients: A Prospective Observational study.
| | AIIMS Hospital | 14-07-2020 | 20200714 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45396 | Not Recruiting | No | | | | 20-07-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Investigator Blinded | N/A | India→ | Yudhyavir Singh→ | | Room No 322A JPNATC AIIMS New Delhi → | yudhyavir@gmail.com→ | 9811140057→ | AIIMS→ | Inclusion criteria: Only confirmed cases of COVID-19 diagnosed on the basis of ICMR standard→ | Exclusion criteria: 1.Age below 6 years. <br/ ><br>2.Pregnant patients <br/ ><br>3.Dialysis dependent patients <br/ ><br>4.All trauma patients <br/ ><br>5.Any malignancy <br/ ><br>6.Any psychiatric illness <br/ ><br>7.Consent not given <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B349- Viral infection, unspecified
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | To evaluate the ability of the NLR and PLR to predict severity in COVID-19 patients. <br/ ><br>Timepoint: Baseline-on admission <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026571 | 27 January 2021 | Pattern of ocular surface involvement in COVID-19 patients in Hassan,Karnataka. | Pattern of ocular surface involvement in COVID-19 patients in HIMS Hassan | | Hassan Institute of Medical sciences Hassan | 14-07-2020 | 20200714 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45426 | Not Recruiting | No | | | | 21-07-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Sandeep K→ | | Room no 175,
Department of ophthalmology,
Hassan institute of medical sciences,
Hassan → | drsandeepsms@gmail.com→ | 9739461055→ | Hassan Institute Of Medical Sciences Hassan→ | Inclusion criteria: 1.COVID -19 Positive(RT-PCR)patients of either sex.→ | Exclusion criteria: 1.Patients who have not given consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1.Incidence of ocular surface manifestations in COVID 19 positive patients in Hassan,Karnataka.Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026575 | 27 January 2021 | Sahadevi Choorna for COVID 19 | Evaluation of Effect of Sahadevi (Vernonia cinerea) Powder in symptomatic improvement of mild to moderate COVID 19 Positive Patients a double blind placebo controlled study. | | Parul Institute of Ayurved Parul University | 14-07-2020 | 20200714 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45500 | Not Recruiting | No | | | | 20-07-2020 | 48 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 2 | India→ | Dr Nandakishor P Umale→ | | Department of Panchakarma, Parul Institute of Ayurved and research Limda Vadodara Gujarat 391760 → | nandkishor.umale260079@paruluniversity.ac.in→ | 8379815979→ | Parul Institute of Ayurveda and Research Parul University→ | Inclusion criteria: Confirmed cases of COVID 19 infections within three days of diagnosis and showing mild to moderate symptoms <br/ ><br>Subjects who are not suffering from any comorbid condition of COVID 19 diabetes hypertension IHD <br/ ><br>Subjects willing to sign informed consent→ | Exclusion criteria: Subjects who are known cases of immunecompromised or autoimmune condition such as HIV <br/ ><br>Pregnant and lactating women <br/ ><br>Patients needing intensive care unit treatment protocol→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J969- Respiratory failure, unspecified
→ | Intervention1: Cap of Sahadevi Powder: Dose 2 cap[1gm powder] <br>Frequency Thrice daily with warm water after food<br>route of administration oral<br>Duration of therapy 15 days<br>Control Intervention1: Cap placebo [wheat powder 500 mg] <br>Dose 2 capsule <br>Frequency three times a day<br>Route of administration Oral<br>Duration 15 days <br>: Standard care as per modern sciences<br><br>→ | Reduction in symptom of COVID 19 <br/ ><br>To reduce Complication of diseaseTimepoint: 3rd day <br/ ><br>5th day <br/ ><br>8th day <br/ ><br>16th day after intervention→ | | | | Yes | False | | |
| → | CTRI/2020/07/026570 | 27 January 2021 | Safety and efficacy of Ayurvedic Capsule in mild to moderate COVID-19 infection. | A double blind randomized controlled trial to assess safety and efficacy of Cap. IP in COVID-19 positive patients with mild to moderate severity for early recovery, in restoring respiratory health and in improvement in innate immunity | | AMAI Charitable Trust Pune | 14-07-2020 | 20200714 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45007 | Not Recruiting | No | | | | 15-07-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Hrishikesh Rangnekar→ | | D 204, Sun Planet, Sun city, Anand Nagar,→ | sureshpatankar51@gmail.com→ | | Quest Clinical Services→ | Inclusion criteria: 1.Age > 18 years <br/ ><br>2.All sexes <br/ ><br>3.Case definitions for inclusion in the study will include mild to moderately severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVI19 issued by Ministry of Health and Family Welfare, Govt of India on 07 Apr 2020. <br/ ><br>Mild: Cases presenting with fever and/or upper respiratory tract illness (Influenza like Illness, ILI); Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%). OR <br/ ><br>4.Laboratory confirmed SARS CoV-2 infection within last 10 days or SARS CoV-2 test result pending with a high clinical suspicion as defined by: Cough of more than 10 days duration OR <br/ ><br>5.Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air, where no alternative explanation for respiratory symptoms can be given <br/ ><br>→ | Exclusion criteria: 1.Pregnant or lactating women <br/ ><br>2.Symptoms of acute respiratory tract infection for more than seven days <br/ ><br>3.More than 48 hours have elapsed between meeting inclusion criteria and enrolment <br/ ><br>4.Subject is also a participant of any other clinical trial <br/ ><br>5.Serious / long-standing co-morbid conditions <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Cap. IP: Ayurvedic formulation to be taken twice daily in addition to standard of care<br>Control Intervention1: Placebo: Capsule to be taken twice daily in addition to standard of care<br>→ | Efficacy of Cap. IP (500 mg) in boosting innate immunity of patients with COVID-19 infection in one months duration.Timepoint: 1 month→ | | 03/09/2020 | | Yes | False | | |
| → | CTRI/2020/07/026559 | 27 January 2021 | Survey about knowledge towards blood donation during COVID 19 pandemic | Perception towards blood donation among blood donors during COVID pandemic in Southern Karnataka: Knowledge, attitude and practice survey. | | Deepika Chenna | 14-07-2020 | 20200714 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45544 | Not Recruiting | No | | | | 21-07-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Deepika Chenna→ | | Department of Immunohematology and Blood Transfusion, KMC, Manipal Department of Immunohematology and Blood Transfusion, KMC, Manipal, Manipal Academy of Higher Education, Manipal→ | deepu.kkd@gmail.com→ | 9901470899→ | Kasturba Medical College, Manipal,→ | Inclusion criteria: Individuals above 18 years and Below 65 years who come for blood donation at Kasturba Hospital, Manipal will be included.→ | Exclusion criteria: Individuals below 18 years and above 65 years will be excluded from the study→ | | | This study would help in understanding the knowledge possessed by community towards blood donation during a pandemic, their feelings and their actions towards situation.Timepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/07/026579 | 27 January 2021 | Role of Herbal Immunomodulators in in Boosting the Immunity among healthcare workers assigned to COVID-19 wards | An Open Label, Prospective, Clinical Study to Evaluate The Role Of Herbal Immunomodulators (Tab Immusante and Tab Guduchi) in Boosting the Immunity among healthcare workers assigned to COVID-19 wards | | The Himalaya Drug Company | 14-07-2020 | 20200714 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45034 | Not Recruiting | No | | | | 24-07-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Soorya Narayan H→ | | Room No 301,3rd Floor Clinical Phramacology. Reserach and Development Makali,Tumkur Road, → | dr.palani@himalayawellness.com→ | | The Himalaya Drug Company→ | Inclusion criteria: 1.Male or non-pregnant female subjects, aged 18-60 years old, <br/ ><br>2.High risk people like Health care workers (Doctors, Nurse, Laboratory technicians, Other hospital support staff), community health care workers assigned to COVID-19 wards. <br/ ><br>3. Female of child-bearing potential willing to follow reliable and strict contraceptive measures. <br/ ><br>4. Subjects judged to be reliable for compliance for taking medication and capable of recording the effects of the medication and motivated in receiving benefits from the treatment and willing to follow the regulations as per prevailing guidelines. <br/ ><br>5. Willing to give written informed consent to participate in the study.→ | Exclusion criteria: Current active/ Confirmed / relapsed COVID-19 positive cases <br/ ><br>2. Pregnant or lactating women. <br/ ><br>3. Recent history of significant lung disease like Asthma or Chronic Obstructive Lung Disease (COPD). <br/ ><br>4. Unable to take oral medication or suffering from ailments related to absorption. <br/ ><br>5. Suffering from Immunocompromising conditions or taking any immunosuppressing therapy. <br/ ><br>6. Subjects suffering from severe and uncontrolled metabolic/endocrinal/cardiac/renal/liver disease. <br/ ><br>7. The subject with known hypersensitivity to any of the test materials or related compounds. <br/ ><br>8. The subject who are unable or unwilling to comply fully with the study protocol. <br/ ><br>9. Physician makes a decision that trial involvement is not in subjectsâ?? best interest, or any condition that does not allow the protocol to be followed safely.→ | | Intervention1: Tab. Immusante and Tab. Guduchi: Herbal Formulations (Tab. Immusante and Tab. Guduchi)- Each tablet is recommended at a dose of 1 tablet twice daily orally (BD) for 30 days<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | Incidence of subjects presenting with respiratory symptoms during study <br/ ><br>Improvement in the immune status based on the adapted Immune status Questionnaire (ISQ) <br/ ><br>Overall well-being (SF-12 Health Survey) <br/ ><br>Timepoint: Visit 1 Baseline <br/ ><br>Visit 2- Day 7±3day/ Telephonic optional <br/ ><br>Visit 3- Day 14±3day/ Telephonic optional <br/ ><br>Visit 4- Day 30±3day/EOS (Telephonic optional) <br/ ><br>Visit 5-Day 45±3day/ Follow-up visit (Telephonic optional) <br/ ><br>Either Visit 4 or Visit 5, one of the Visit should be Onsite Visit→ | | 07/09/2020 | | Yes | False | | |
| → | CTRI/2020/07/026568 | 27 January 2021 | Ayurveda Rasayan therapy for reducing risk of COVID infection in high risk individuals with comorbidities | Reducing the risk of developing symptomatic Corona virus disease and reducing requirement of hospitalization by administering Ayurveda Rasayana therapy as a prophylactic therapy to individuals residing Coronavirus Hotspots and having comorbidities which increases the risk of developing severe stage Coronavirus disease or ARDS | | Ayurved Rasayani | 14-07-2020 | 20200714 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45035 | Not Recruiting | No | | | | 15-07-2020 | 60 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Ketaki Jagtap→ | | Rasayu Ayurved Clinic Flat No 1 and 2 Shreevijaya Apts Neelkamal Society Karvenagar Pune → | physician1@rasayuayurvedclinic.com→ | 9766897894→ | Rasayu Ayurved Clinic→ | Inclusion criteria: 1 Individuals residing in Corona virus Hotspots as declared by Authorities <br/ ><br>2 Individuals having any of the following comorbidities <br/ ><br>3 Chronic Diabetic with more than 5 yearsof knownon set Chronic hypertensive with more than 5years of knownon set Patients with active malignancies or taking or taken anticancer therapy within last 6months Patients with chronic lowerrespiratory disease Patients with chronic liver or renalfailure Patients having immunosuppressivetherapies Or elderly person above 65 years of age with or without any comorbidities <br/ ><br>→ | Exclusion criteria: Pregnant women or women who are breast feeding <br/ ><br>Consideration by the investigator for any reason that the subject is an unsuitable candidate to receive study treatment <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Pragmatic clinical study which studies the whole system personalised approch of meedcine practice.: The investigator can prescribe the medcine which are based on his clinical logical .The medcine prescribed and dosage used will be analysed during the overall analysis of the study<br>→ | Incidence of individual becoming positive as determined by PCR or any other approved commercial or public health assays <br/ ><br>Timepoint: Time Frame on day 30 or development of symptoms of corona virus disease <br/ ><br>Severe stage→ | | | | Yes | False | | |
| → | CTRI/2020/07/026611 | 27 January 2021 | Surgical Outcomes in COVID-19 Patients (SOVID) | Surgical Outcomes in COVID-19 Patients (SOVID): Multicentric Observational Study - SOVID | | SGPGIMS | 15-07-2020 | 20200715 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44568 | Not Recruiting | No | | | | 24-07-2020 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Mallikarjun Gunjiganvi→ | | Apex Trauma Center,
SGPGIMS,
Lucknow
Department of Critical Care Medicine, SGPGIMS,
Lucknow→ | gunjiganvi@gmail.com→ | 8004900947→ | Sanjay Gandhi Post Graduate Institute of Medical Sciences→ | Inclusion criteria: During study period, all surgeries being done on adult patients who are: a) Pre-operative confirmed COVID-19 positive report; or b) report turned out to be positive after surgery from samples taken in pre-operative period.→ | Exclusion criteria: Children less than 18 years. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To study survival at hospital discharge <br/ ><br>Timepoint: At discharge, 2 weeks, 4 weeks and 6 weeks <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026612 | 27 January 2021 | Psycho-social Problems among COVID Infection Survivors | Mental Health and Psychological Problems among COVID-19 ICU Survivors | | SGPGIMS | 15-07-2020 | 20200715 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45100 | Not Recruiting | No | | | | 24-07-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Mallikarjun Gunjiganvi→ | | 620, Faculty Block,
Apex Trauma Center,
SGPGIMS,
Lucknow Dept. of Critical Care Medicine,
SGPGIMS, Lucknow→ | gunjiganvi@gmail.com→ | | Sanjay Gandhi Post Graduate Institute of Medical Sciences→ | Inclusion criteria: All COVID-19 positive patients admitted to ICU and surviving ICU discharge will be included→ | Exclusion criteria: Age less than 18 yrs→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Mental health and psychological problems among COVID-19 ICU survivors <br/ ><br>before and after hospital discharge will be assessed through GAD-7 and PHQ-9 scalesTimepoint: Within 24 hours of planned ICU discharge; 2 weeks of home stay after discharge; optionally at 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026602 | 27 January 2021 | Study of an Ayurveda regimen in COVID Positive patients | A prospective non-randomized interventional study to determine the efficacy of an Ayurveda regimen in COVID Positive patients | | Deenanath Mangeshkar Hospital Research Centre | 15-07-2020 | 20200715 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45628 | Not Recruiting | No | | | | 24-07-2020 | 72 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Pankaj Wanjarkhedkar→ | | Department of Ayurveda & Integrative Medicine; C3 C Wing GS Building Deenanath Mangeshkar Hospital Erandwane Pune → | drwpankaj@gmail.com→ | 02040151005→ | Deenanath Mangeshkar Hospital & Research Centre Pune→ | Inclusion criteria: Patients admitting to IPD of DMHRC; with Mild-Moderate symptoms as per DMER Guidelines (Group B category Fever, Cough, Running nose, without shortness of breath,RR <24/min). Patients with known case of Daibetes Mellitus on OHA, HT & Asthma will be included.→ | Exclusion criteria: Patients with co-morbidities like COPD,IHD,CKD, Coagulopathy, Cancer will be excluded. Diabetic Patients taking Insulin will be excluded. Patients with Sr. Creatinine >1.5, Sr. Sodium <128, Hb <7.0gm%, SPO2 <90 will be excluded. Preganant& Lactating mothers will be excluded. Patients who are on Immuno-suppresants, Chemotherapy drugs will be excluded. By any reason / after any major Oral surgery etc, if patient is not able to swallow tablets will be excluded.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Guluchyadi Kwatham Tablet: Ayurveda Classical Formulation<br>Dosage - 2 Tablets Twice daily after Food<br>Route of administration - ORAL<br>Duration of treatment - 7 Days<br>Intervention2: Dasamoolakadutrayadi Kashayam Tablet: Ayurveda Classical Formulation<br>2 Tablets Twice Daily after meals <br>Route of Administration - ORAL<br>Duration of Treatment - 7 days<br>Control Intervention1: Standard of Care: Standard of Care as per present guidelines by ICMR<br>→ | Outcome will be assessed on: 1. Episodes & grade of Fever <br/ ><br>2.Episodes of Breathlessness <br/ ><br>3. Sore Throat <br/ ><br>4. Fatigue 5. Cough 6. Anosmia 7. Any GI symptoms 8. SPO2 9. Duration of Hospital stayTimepoint: Baseline - At Enrollment <br/ ><br>and <br/ ><br>At Day 7→ | | | | Yes | False | | |
| → | CTRI/2020/07/026608 | 27 January 2021 | A clinical trial to study the effects of two drugs methylprednisolone and dexamethasone in patients with severe COVID-19 | Randomized Study Of the Effect of Dexamethasone and Methylprednisolone on levels of IL-6 and clinical outcome in severe COVID-19 - REDMIC | | Dr Ananthakumar P K | 15-07-2020 | 20200715 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45638 | Not Recruiting | No | | | | 27-07-2020 | 40 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ananthakumar P K→ | | Department of General Medicine
A Block
Chettinad Hospital and Research Institute
Kelambakkam → | medicinehod@chettinadhealthcity.com→ | 9841210011→ | Chettinad Academy of Research and Education→ | Inclusion criteria: Age more than 18 years old <br/ ><br>Both sex <br/ ><br>Lab. Confirmed COVID-19 cases with ARDS <br/ ><br>→ | Exclusion criteria: Mild and moderate COVID-19 <br/ ><br>Severe immunosuppression (HIV infection, long-term use of immunosuppressive agents <br/ ><br>Pregnant or lactating women <br/ ><br>Patients already on steroids <br/ ><br>Patients with High Procalcitonin level <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Injection Methylprednisolone: 1 mg/kg Intravenous once a day for 3 days<br>Control Intervention1: Injection Dexamethasone: 6 mg intravenous once a day for 3 days<br>→ | Primary outcomes: <br/ ><br>Difference in IL-6 level from baseline. <br/ ><br>Days to ventilator liberation <br/ ><br>Length of hospital stay (LOS). <br/ ><br>In-hospital all-cause mortality. <br/ ><br>The secondary outcomes <br/ ><br>Time to fever resolution <br/ ><br>Levels of bio-markers (CRP, D dimer, Ferritin) on Day 1 and Day 3. <br/ ><br>Timepoint: Day 1 and Day 3 for IL-6 level <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026610 | 27 January 2021 | General anaesthesia with aerosol box during COVID pandemic | Prospective Study of Intubation Outcomes using the Aerosol Box during the COVID-19 Pandemic | | Cancer Institute WIA | 15-07-2020 | 20200715 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45643 | Not Recruiting | No | | | | 28-07-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Meenakshi V V→ | | Department of Anaesthesia.
Cancer Institute (WIA)
Dr S. Krishnamurti Campus, Sardar Patel Road. Cancer Institute (WIA)→ | meenaram99@yahoo.com→ | 9940370735→ | Cancer Institute, Adyar, Chennai.→ | Inclusion criteria: 1.Age: Patients of both sexes greater than or equal to 18 yrs of age <br/ ><br>2.Patients receiving suxamethonium or rocuronium (if allergic to suxamethonium or contraindication to suxamethonium) will be included. <br/ ><br>3.Intubations performed by anaesthesiologists who have â?¥ 3 years clinical experience following their training will be considered for the study. <br/ ><br>4.Anaesthesiologists will use the conventional Macintosh Laryngoscope or the C-Mac Video Laryngoscope depending upon the availability and comfort. <br/ ><br>→ | Exclusion criteria: 1.Patients requiring awake fiberoptic guided intubation. <br/ ><br>2.Patients who cannot fit within the aerosol box due to their body habitus. <br/ ><br>3.Patients who are undergoing emergency surgery and are at risk for gastric aspiration. <br/ ><br>4.Patients requiring double lumen tube (DLT) insertion <br/ ><br>→ | Health Condition 1: C00-D49- Neoplasms
→ | | Time to intubation- defined as time from when the laryngoscope blade passes between the patients lips until the first upstroke of the capnograph traceTimepoint: 24 hours→ | | | | Yes | False | | |
| → | CTRI/2020/07/026609 | 27 January 2021 | Yoganidra benefits on COVID health care workers | Effect of Yoganidra on COVID health care workers: Pilot Study | | SGPGIMS | 15-07-2020 | 20200715 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45139 | Not Recruiting | No | | | | 24-07-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Dr Mallikarjun Gunjiganvi→ | | 620, Faculty Block,
Apex Trauma Center,
SGPGIMS,
Lucknow- 226014 Dept. of Critical Care Medicine,
SGPGIMS, Lucknow- 226014→ | gunjiganvi@gmail.com→ | 8004900947→ | Sanjay Gandhi Post Graduate Institute of Medical Sciences→ | Inclusion criteria: Covid health care workers in the frontline of COVID-19 duty (Physicians, Residents and Staff Nurses) willing to participate in the study and should have the knowledge of English Language <br/ ><br>→ | Exclusion criteria: Covid health care workers who become symptomatic of COVID-19 disease during the study period needing hospitalization.→ | | Intervention1: YOGANIDRA: YOGANIDRA is state of Conscious sleep performed by lying down in supine position. In this technique, participants will be awake and are aware about the different body parts.<br><br>Frequency -On daily basis at a suitable and convenient time due to multiple shift nature of duty hours (inherent to COVID infection)<br><br>Time: Administered daily for 30 minutes duration<br>Control Intervention1: SUPINE RELAXATION MUSIC: SUPINE RELAXATION is state of lying down in supine position and listening to the sleep relaxation music.<br>Frequency -On daily basis at a suitable and convenient time due to multiple shift nature of duty hours (inherent to COVID infection)<br><br>Time: Administered daily for 30 minutes duration<br>→ | Impact of Yoganidra on Depression, Anxiety and Insomnia among <br/ ><br>Covid Warriors using: Patient Health Questionnaire (PHQ-9) scale; Generalized Anxiety Disorder (GAD-7) scale; 7-item Insomnia Severity Index scale.Timepoint: Baseline, 2 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/07/026607 | 27 January 2021 | Evaluation of Non Invasive Ventilator | Evaluation of the SwasthVayu- Bi level Positive Airway Pressure system | | CSIR National Aerospace Laboratories | 15-07-2020 | 20200715 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43998 | Not Recruiting | No | | | | 22-07-2020 | 10 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Sathyanarayana Mysore→ | | No 8, -1 floor, Department of Pulmonology
98 Manipal Hospital OLD HAL Airport Road Kodihalli Bangalore 560017 No 8, -1 floor, Department of Pulmonology,
98 Manipal Hospital OLD HAL Airport Road Kodihalli Bangalore 560017→ | satya.mysore@manipalhospitals.com→ | 9741303009→ | Manipal Hospital→ | Inclusion criteria: 1. pH being less than 7.25 or respiratory acidosis with CO2 retention. <br/ ><br>2. Use of accessory muscles of respiration, increased work of breathing, paradoxical respiration, retraction of intercostal muscles. <br/ ><br>3. Persistent hypoxemia despite using supplemental oxygen <br/ ><br>→ | Exclusion criteria: 1. Unable to tolerate NIV <br/ ><br>2. Diminished consciousness, psychomotor agitation inadequately controlled by sedation <br/ ><br>3. Massive aspiration or persistent vomiting. <br/ ><br>4. Persistent inability to remove respiratory secretions. <br/ ><br>5. Severe hemodynamic instability without response to fluids or vasoactive drugs. <br/ ><br>6. Severe ventricular or supraventricular arrhythmia. <br/ ><br>7. Status post cardiac arrest or respiratory arrest. <br/ ><br>8. Life threatening hypoxia in a patient unable to tolerate NIV <br/ ><br>→ | Health Condition 1: J439- Emphysema, unspecified
→ | Intervention1: BiPAP Auto Biflex Philips Respironics IN761S: BiPAP Machine manufactured by Philips has modes CPAP and BiPAP with spontaneous modes. SwasthVayu has few additional modes like Spontaenous with Auto Timed mode (S/T) as well as HEPA T filter arrangement at MASK exclusively to treat COVID-19 patients to minimise the spread of virus.Hence SwasthVayu canbe compared with Philips Machine only ofr performance of modes which are common.<br>→ | improvement in oxygenation <br/ ><br>Improvement in hypoxia <br/ ><br>improvement in hypercarbiaTimepoint: Immediately after the trial of 120 mins for each patient→ | | | | Yes | False | | |
| → | CTRI/2020/07/026601 | 27 January 2021 | A study to check effect of an Ayurvedic treatment on corona positive patients | A prospective, interventional, single group study to evaluate safety and effectiveness of an Ayurvedic regimen as an add on treatment in hospitalized SARS-CoV2 tested positive pre-symptomatic, mild or moderate COVID-19 cases - COVID-19 | | Aarti Foundation Mumbai and Kutchhi Jain Foundation Mumbai | 15-07-2020 | 20200715 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45564 | Not Recruiting | No | | | | 21-07-2020 | 70 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | DrShivprasad Charkha→ | | Shree Ayurved Chikitsalaya, Near Sarda Capital, Sahayognagar, DP Road, Beed, Maharashtra → | shriayurved104@gmail.com→ | 9422240104→ | Shri Sant Dnyaneshwar Mauli Ayurved Pratishthan, Beed→ | Inclusion criteria: 1. Individuals of either sex above 18 <br/ ><br>2. People who have been tested positive to be infected with SARS-CoV2 virus and presenting with no symptoms or mild to moderate symptoms. <br/ ><br>3. Subject who agrees for giving informed consent and provide signed and dated written IEC approved Informed Consent Form (ICF) prior to initiation of any study procedures→ | Exclusion criteria: 1. Subjects who are not able to or not willing to sign an IRB/IEC approved consent form. <br/ ><br>2. COVID patients with symptoms classified as severe or critical. <br/ ><br>3. Persons with severe primary respiratory disease or other pneumonia <br/ ><br>4. Pregnant women <br/ ><br>5. Persons with serious complications of diseases such as cancer, heart disease, stroke, disabilities, mental illnesses, etc., and who are considered to be excluded from the study as evaluated by the investigators <br/ ><br>6. COVID-19 positive cases participating as subjects in the interventional arm of other COVID-19 clinical trials→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: An Ayurvedic regimen: Patients in study group will receive following interventions along with conventional treatment.<br>1. Surasadi Kadha<br>Name of intervention: Surasadi Kadha<br>Route of administration: Oral<br>Dose: 50 ml TDS<br>Duration: 7 days<br>2. Capsule Vironil<br>Name of intervention: Capsule Vironil<br>Route of administration: Oral<br>Dose: 500 mg OD<br>Duration: 7 days<br>3. Capsule Bilvadi<br>Name of intervention: Capsule Bilvadi<br>Route of administration: Oral<br>Dose: 400 mg TDS<br>Duration: 7 days<br>Control Intervention1: Lukewarm Water: Patients in control group will receive conventional treatment and lukewarm water.<br>→ | Change in result of RT-PCR test for SARS-CoV2Timepoint: Day 1 and 8→ | | 23/08/2020 | | Yes | False | | |
| → | CTRI/2020/07/026630 | 27 January 2021 | Clinical trial of ACT 12 tablet and ACT 13 dry syrup in Covid 19 patients | Phase II, open label, randomized controlled trial to evaluate safety
and efficacy of ACT 12 tablet and ACT 13 dry syrup as an
immunomodulator in adult Covid 19 positive patients | | Mr Ghanshyam Goti | 16-07-2020 | 20200716 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45581 | Recruiting | No | | | | 22-07-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 2 | India→ | Dr Pawan Kumar Singh→ | | Second floor, Cabin No. 1, Sagar Complex, Old Pune-Mumbai Road,Chinchwad, Pune → | gplifehealthcare@gmail.com→ | 9824917109→ | Gplife Healthcare Pvt Ltd→ | Inclusion criteria: Patients admitted with RT-PCR confirmed COVID-19 illness <br/ ><br>Age more than 18 & less than 65 years of either sex <br/ ><br>Mild to Moderately Covid 19 disease (NEWS score less than or equal to 8) <br/ ><br>Signed informed consent must be obtained and documented according to national/local regulations→ | Exclusion criteria: Pregnant women <br/ ><br>Breastfeeding women <br/ ><br>Requiring ICU admission at screening <br/ ><br>Patients above 65 years of age and below 18 Years <br/ ><br>Past History of MI, Epileptic episodes <br/ ><br>Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which <br/ ><br>is at critical stage at screening <br/ ><br>Any other condition by which subject proves unfit from investigator perspective <br/ ><br>Not giving consent.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ACT 12 tablet and ACT 13 dry syrup: 2 tablets of ACT12 and 20 ml ACT 13 dry syrup thrice a day along with standard of care for 10 days<br>Control Intervention1: Standard treatment: Standard treatment as per<br>protocol of ICMR for 10 days<br>→ | No. of days for negative PCR confirmatory test from nasopharyngeal swab for COVID 19. <br/ ><br>Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure <br/ ><br>in the chest, bluish discoloration of lips/ face on 5 point ordinal scale:None (1), mild (2), moderate (3), severe (4), extremely severe (5) <br/ ><br>Serum levels of CRP, IgM, IgG. <br/ ><br>Clinical status expressed in percentage of subjects on 6 point ordinal scale.Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 ie end of study→ | | | | Yes | False | | |
| → | CTRI/2020/07/026632 | 27 January 2021 | Siddha Treatment for COVID 19- a Pilot Study | Effectiveness Of Siddha Medicine In The Treatment Of COVID 19 Patients- a Pilot study
| | Government siddha medical college | 16-07-2020 | 20200716 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45680 | Not Recruiting | No | | | | 27-07-2020 | 40 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Dr J Nikil Niva→ | | Op no 2
Department of General Medicine
Government Siddha Medical College
Arumbakkam → | nikilniva@gmail.com→ | 7200333774→ | Government Siddha Medical College→ | Inclusion criteria: Patients with the diagnosis of laboratory confirmed COVID 19 <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Patients With other Acute Respiratory Distress Syndrome or other comorbidities of lungs <br/ ><br>2. Pregnant and Lactating Mothers <br/ ><br>3. Patients with severe primary respiratory disease or other pathogenic microbial pneumonia that needs to be identified with COVID 19. <br/ ><br>4. patients participating in other clinical trials→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 1. AAdathodai kudineer<br>2. thaalisathi chooranam <br>thulasi chooranam<br>pavala parpam <br>3. bramanandha bairava mathirai<br>4. thoothuvalai nei: 1. AAdathodai kudineer-15-30 ml bd with Oral Administration -10 Days<br>2. thaalisathi chooranam <br>thulasi chooranam<br>pavala parpam -All the 3 ingredients are mixed -2gm bd with honey Oral Administration- 10 days <br>3. bramanandha bairava mathirai- 1bd with honey - oral administration-10 days<br>4. thoothuvalai nei 5-10ml bd- oral administration-10 days<br>Control Intervention1: Siddha COVID 19 treatment trial medicines: 1. Aadathodai kudineer -15-30 ml bd <br>2. Thaalisaathi chooranam<br>Thulasi chooranam<br>Pavala Parpam-2gm bd with nhoney<br>3. Bramaanandha Bairava Maathirai-1bd with honey<br>4. Thoothuvalai Nei 5-10 ml along with food<br>Control Intervention2: nil: nil<br>→ | To determine the effectiveness of Siddha Medicine in Acceleration of recovery or Reduction in number of days to become test negative / symptom free in COVID 19 patientsTimepoint: 3 month→ | | | | Yes | False | | |
| → | CTRI/2020/07/026631 | 27 January 2021 | Uses of herbal combination by taking it in hot water in covid 19 positive patients. | A multi centre clinical trial to study the safety and efficacy of herbal combination in covid 19 positive patients in Murugaa hospital and fertility centre | | Kumarans fertility centre | 16-07-2020 | 20200716 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45494 | Not Recruiting | No | | | | 19-07-2020 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr S Saravanan M B B S M MED in fam med C M C VELLORE→ | | 479 2b Room no 4 Ground Floor Murugaa hospital fertility centre K Chettipalayam Dharapuram road Tirupur 641604 479 2b Murugaa hospital fertility centre K Chettipalayam Dharapuram road Tirupur 641604→ | success3212000@gmail.com→ | 08778731043→ | MURUGAA HOSPITAL FERTILITY CENTRE→ | Inclusion criteria: From newborn to 80 years.patients admitted in hospital and in general public who are in home quarantine after testing corona(covid19) positive.→ | Exclusion criteria: Covid 19 positive pregnant patients And Carcinoma patients (Any type)→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J108- Influenza due to other identifiedinfluenza virus with other manifestations
→ | Intervention1: Herbal formulation in hot water: A Herbal formulation contains powder of herbs which are having immunobooster properties<br>Intervention2: Herbal formula: Herbals powder which have immunobooster properties to fight against covid 19<br>Intervention3: herbals powder: 2 grams three times daily in hot water after food by oral route for seven days(This powder contains Zingiber officinale Piper nigrum Alpinia officinarum Melia Dubia Justicia adhatoda Anethum sowa Mollugo serviana Cuminum cyminum Curcuma longa)<br>Control Intervention1: Not applicable: Not applicable<br>→ | COVID 19 Positive Patients results will be turn negative after one week of taking herbal formulation by oral route for one week in hot water or in honey will be assessed by either clinicaly by evaluating their spO2 levels or by RT-PCR.Timepoint: one week→ | | 03/09/2020 | | Yes | False | | |
| → | CTRI/2020/07/026658 | 27 January 2021 | Teleophthalmology experience during COVIDâ??19 lockdown. | Teleophthalmology experience during COVIDâ??19 lockdown. | | Dr Ankita Sangle | 17-07-2020 | 20200717 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45350 | Not Recruiting | No | | | | 18-07-2020 | 400 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ankita Sangle→ | | Department of Ophthalmology, Kasturba hospital, Manipal, Karnataka-576104. → | priya.ramesh91@gmail.com→ | 9964723459→ | Kasturba medical college, Manipal academy of higher education, Manipal.→ | Inclusion criteria: All Ophthalmologists practising in India willing to participate will be included in the study.→ | Exclusion criteria: Doctors from other medical specialities other than <br/ ><br>ophthalmology. Ophthalmologists who do not wish to participate.→ | | Intervention1: Nil: Nil<br>→ | This study will give an insight into teleophthalmology practices. <br/ ><br>Implementation of teleophthalmology.Timepoint: 2 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026667 | 27 January 2021 | : Efficacy of Pranayama on Positivity rate in People exposed to Covid-19 Patients and mental status | : Efficacy of Pranayama on Positivity rate in People exposed to Covid-19 Patients and mental status | | Ministry of AYUSH | 17-07-2020 | 20200717 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44342 | Not Recruiting | No | | | | 17-07-2020 | 250 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Ishwarappa V Basavaraddi→ | | Room Directors Office 68 Ashoka Road Delhi 110001 → | ibasavaraddi@yahoo.co.in→ | 9810800289→ | Morarji Desai National Institute of Yoga→ | Inclusion criteria: Inclusion Criteria <br/ ><br> <br/ ><br>1. Contacts (Individuals) who have been exposed to COVID-19 suspects or cases and are in quarantine. <br/ ><br> <br/ ><br>2. Family members of the COVID positive cases <br/ ><br>3. Subject ready to practice Pranayam. <br/ ><br>→ | Exclusion criteria: Exclusion Criteria <br/ ><br> <br/ ><br>1. Subjects with comorbidities that avert them from practicing Pranayam <br/ ><br> <br/ ><br>2. Subjects who do not consent for the study <br/ ><br>3. Severe cardiac patients etc. <br/ ><br>→ | | Intervention1: Pranayama Module: S. No Practices Name of Practice Rounds Duration<br> (in Minutes)<br> <br>1 Prayer 3-5 deep breathing/ prayer of 1<br> individual <br> <br> <br>2 3 rounds 2.5<br> Preparatory Vaataneti <br> (30 secs/round) <br> Practices <br>3 3 rounds 2.5<br> Kapalabhati <br> (30 secs/round) <br> <br>4 Deep Breathing 10 rounds 3<br> <br>5 Nadishodhana 10 rounds 8<br> Breathing <br>6 Ujjaayee 10 rounds 5<br> Practices <br> <br> <br>7 Bhramari 10 rounds 5<br> <br>8 Awareness of breathing or 3<br> Meditation Dhyana Awareness of Positive thoughts/ <br> emotions/ actions <br> <br>Total Duration 30<br> <br><br>Control Intervention1: Control group subjects shall be asked to perform their normal daily routine, no pranayama sessions: No pranayama sessions<br>→ | Primary outcome: <br/ ><br> <br/ ><br>1.Percentage of COVID positive cases in the two arms. <br/ ><br> <br/ ><br>Timepoint: 1.Recruitment of samples and baseline data collection and Training (0-1 week) <br/ ><br>2.Followâ??up period (4 weeks) <br/ ><br>3. Collection of pre-intervention and post intervention data records at the end of 4th week (Rapid antibody test, psychological test) <br/ ><br> <br/ ><br>4. Data analysis and report preparation <br/ ><br>5. Continuation of Pranayama Session up to 12 weeks. <br/ ><br> <br/ ><br> <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026633 | 27 January 2021 | Mental state of the Bangladeshi physiotherapist amid COVID-19 pandemic. | Fear, Depression and insomnia amid COVID-19 pandemic among physiotherapist in Bangladesh. - N/A | | Uttara Adhunik Medical College and Hospital | 17-07-2020 | 20200717 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45666 | | No | | | | 25-07-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Bangladesh→ | Dr Mohammad Ali→ | | Department of Physiotherapy and Rehabilitation, Room no-01 → | alibup2018@gmail.com→ | 8801715043533→ | Uttara Adhunik Medical College and Hospital→ | Inclusion criteria: Graduate registered physiotherapist working in Bangladesh.→ | Exclusion criteria: Currently or previously infected by coronavirus-19→ | | | State of fear, depression and insomniaTimepoint: At baseline→ | | | | Yes | False | | |
| → | CTRI/2020/07/026659 | 27 January 2021 | COVID-19 related study among dental patients in Udupi District | COVID-19 related knowledge, attitude, practice evaluation among dental patients in Udupi District: A cross-sectional survey | | Dr Deeksha Karkada | 17-07-2020 | 20200717 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45431 | Not Recruiting | No | | | | 25-07-2020 | 400 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Investigator Blinded | N/A | India→ | Dr Deeksha Karkada→ | | Room Number 8
Department of Public Health Dentistry
Manipal College of Dental Sciences, Manipal → | sh.acharya@manipal.edu→ | 9448127031→ | Manipal College of Dental Sciences→ | Inclusion criteria: Patients visiting dental clinic on an out-patient basis <br/ ><br>Those who can read and write Kannada <br/ ><br>Those who are willing to provide informed consent→ | Exclusion criteria: Patients who need emergency treatment <br/ ><br>Those who cannot read and write Kannada <br/ ><br>Those who have problems with comprehension and <br/ ><br>Those who are not willing to give informed consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | a.Total score of knowledge, attitude, practice questionnaire <br/ ><br>b.Total score of perceived stress scale <br/ ><br>Timepoint: 40 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/07/026664 | 27 January 2021 | To find the frequency of misting "fogging"of protective spectacles and comparison of various techniques to reduce misting of spectacles while working in intensive care unit during COVID 19 pandemic | The Prevalence of fogging with protective eye wear and comparison of various techniques to reduce fogging in intensive care unit during COVID 19 pandemic-Fog Lens study | | Natesh Prabu | 17-07-2020 | 20200717 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44690 | Not Recruiting | No | | | | 20-07-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Natesh Prabu R→ | | Department of Critical Care Medicine first floor ICU new silver jubilee block St Johns Medical College Hospital Sarjapura road Bengaluru → | drnateshrprabu@gmail.com→ | | St Johns Medical College Hospital→ | Inclusion criteria: 1. All health care workers (doctors, nurses, support staff) posted/working in COVID intensive care unit→ | Exclusion criteria: Those who are not willing to participate in study→ | | Intervention1: techniques of wearing protective eye wear and respirator mask: a. Increasing the distance between the protective goggles and eyes<br>b. Washing the protective goggles with soap and air drying before use<br>c. Use of an adhesive tape between upper part of mask and face to create a better seal<br>d. Use of 3M 7502 half face Elastomeric Respirator<br><br>Control Intervention1: N95 mask with protective eye wear<br>: N95 mask with protective eye wear<br><br>→ | To study the prevalence of Protective eye wear fogging that hampers visionTimepoint: Immediately at the time of assessing the Primary out come→ | | | | Yes | False | | |
| → | CTRI/2020/07/026660 | 27 January 2021 | A study to measure the mental stress of the upcoming primary caregivers of children cancer patients diagnosed with Covid-19 illness | Assessing Psychological Distress in Primary
Caregivers of Children with Cancer during COVID-19 Pandemic â?? A Prospective
Cohort Study | | Tata Memorial Hospital | 17-07-2020 | 20200717 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45715 | Not Recruiting | No | | | | 27-07-2020 | 100 | Observational | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Badira Cheriyalinkal Parambil→ | | Tata Memorial Hospital. Department of Medical Oncology-Pediatrics. OPD No. 88, Main Building Ground Floor, Dr. Earnest Borges Road. Parel. Mumbai → | badiracp@yahoo.co.in→ | 9495640194→ | Tata Memorial Hospital→ | Inclusion criteria: 1. Primary caregiver of children with cancer(â?¤15-years) taking cancer treatment at Tata Memorial Hospital <br/ ><br>2. Directly involved with patient care during cancer treatment <br/ ><br>3. Informed consent of the primary caregiver <br/ ><br>4. Should have telephones→ | Exclusion criteria: 1. Caregivers with a history of known pre-existing psychiatric disorder or cognitive <br/ ><br>impairment <br/ ><br>2. Caregivers unable to comprehend Hindi/Marathi/English→ | | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | To evaluate the psychological distress in primary caregivers of children with cancer during COVID-19 pandemic.Timepoint: Baseline (Study Entry), First Week, Second Week, Third Week, Fourth Week after enrolment→ | | | | Yes | False | | |
| → | CTRI/2020/07/026669 | 27 January 2021 | Unani Herbal tablets for mild cases od Covid 19 | A clinical study to evaluate the efficacy of tablet of Aloe Vera gel (Aloe barbadenesis),Mur Makki (Commiphora myrrha) and Sanna-e-Makki (Senna Alexandrina) in the management of mild cases of confirmed Covid -19 | | Z V M Unani Medical College | 18-07-2020 | 20200718 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45623 | Not Recruiting | No | | | | 03-08-2020 | 60 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Dr Shaikh Nikhat→ | | Ground Floor Room No 2
Division Nil
Regional Research Institute of Unani Medicine Gate No 9 J J Hospital Compound
Byculla Mumbai→ | jalishmd@yahoo.co.in→ | 09850541686→ | Z V M Unani Medical College and Hospital→ | Inclusion criteria: patients of mild cases of confirmed Covid-19. <br/ ><br>Fever above 1000 F <br/ ><br>Sore throat <br/ ><br>Dry cough <br/ ><br>Breathlessness <br/ ><br>Severe body ache <br/ ><br>SPO2 saturation above 92 <br/ ><br> <br/ ><br>→ | Exclusion criteria: Patients in whom fever does not subside or increase in fever, SPO2 goes below 92.Increase in Breathlessness, then such patients will be excluded from the study. <br/ ><br>Immune- compromised patients. Patient having Ischemic heart disease <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tablet of of Aloe Vera gel (Aloe barbadenesis),Mur Makki (Commiphora myrrha) and Sanna-e-Makki (Senna Alexandrina): Mur Makki (Commiphora myrrha), Aloe Vera gel (Aloe barbadenesis) and Senna Leaves(Senna Alexandrina) will be taken in equal quantity and tablet of 500 mg will be made by local Unani or herbal manufacturing unit.<br>Intervention2: Tablets of Aloe Vera gel (Aloe barbadenesis),Mur Makki (Commiphora myrrha) and Sanna-e-Makki (Senna Alexandrina): Mur Makki (Commiphora myrrha), Aloe Vera gel (Aloe barbadenesis) and Senna Leaves(Senna Alexandrina) will be taken in equal quantity and tablet of 500 mg will be made by local Unani or herbal manufacturing unit.<br>Intervention3: Unani Herbal Formulation in tablet form: Mur Makki (Commiphora myrrha), Aloe Vera gel (Aloe barbadenesis) and Senna Leaves (Senna Alexandrina) will be taken in equal quantity by weight and tablet of 500 mg will be made by registered Unani or herbal manufacturing unit.<br>Control Intervention1: Nil: Nil<br>→ | Improvement in Oxygen saturation of patients and decrease in temperatureTimepoint: SPO2 and temperature will be assessed daily twice from 0 day to 14 day→ | | | | Yes | False | | |
| → | CTRI/2020/07/026673 | 27 January 2021 | Siddha formulations for the prevention of COVID-19 infection | NON RANDOMIZED CLINICAL TRIAL TO EVALUATE THE EFFICACY OF SIDDHA MEDICINES NILAVEMBU KUDINEER AND KABASURA KUDINEER IN THE MANAGEMENT OF COVID 19 PATIENTS: AN INVESTIGATIVE STUDY | | Ministry of AYUSH | 18-07-2020 | 20200718 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45673 | Not Recruiting | No | | | | 05-08-2020 | 60 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | DrCSavariraj SahayamMDPhD→ | | Centre for Advanced Research in Indian systems of Medicine,School of Chemical and Biotechnology SASTRA Deemed University,Thanjavur. → | surgeondrkarthig81@gmail.com→ | 9655990744→ | Thanjavur Medical College→ | Inclusion criteria: â?¢ Laboratory confirmed COVID-19 patients with or without symptoms <br/ ><br>â?¢ Aged 20-60 years <br/ ><br>â?¢ Consenting to participate in the study and sign the informed consent <br/ ><br>â?¢ Hospitalized patients with illness of any duration with SpO2 â?¤ 94% on room air <br/ ><br>→ | Exclusion criteria: â?¢ Patients with severe primary respiratory disease or other pathogenic microbial pneumonia that need to be identified with COVID-19 <br/ ><br>â?¢ Pregnant and lactating mothers. <br/ ><br>â?¢ Patients with other systemic malignant diseases such as malignant tumors, HIV, mental illnesses, etc., which the researchers consider unsuitable for participation in the study <br/ ><br>â?¢ People who have been allergic to Siddha medicine or intolerant to taking medicine <br/ ><br>â?¢ Patients participating in other COVID-19 clinical trials <br/ ><br>â?¢ Spontaneous blood ALT/AST levels > 5 times the upper limit of normal <br/ ><br>â?¢ Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30 mL/min) <br/ ><br>â?¢ Patients previously treated with one of the antivirals evaluated in the trial (i.e. KSK and NVK) in the past 14 days <br/ ><br>â?¢ Contraindication to any study medication including allergy <br/ ><br>â?¢ 10Participation in any other clinical trial of an experimental treatment for COVID-19Evidence of multi organ failure <br/ ><br>→ | Health Condition 1: B999- Unspecified infectious disease
→ | Intervention1: As standard treatment suggested by WHO-ICMR<br>(Treatment period of14days): As standard treatment suggested by WHO-ICMR<br>(Treatment period of 14 days)<br>Control Intervention1: As standard treatment suggested by WHO-ICMR (Treatment period of 14days)and will be supplemented Siddha formulations cosisting of Kudineer: Kabasura kudineer 60mlmorning and evening beforefood Nilavembu kudineer 60 ml morning and evening after food <br>→ | â?¢Reduction in clinical symptoms like fever, cough,sore throat and breathlessness <br/ ><br>Respiratory rate - â?¤24/minute on room air; 3) Oxygen saturation - 94% on room air; (4) Cough - mild or absent on a patient reported scale <br/ ><br>Timepoint: â?¢Reduction in clinical symptoms like fever, cough and breathlessness <br/ ><br>Respiratory rate - â?¤24/minute on room air; 3) Oxygen saturation - 94% on room air; (4) Cough - mild or absent on a patient reported scale <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026668 | 27 January 2021 | To study the effect of BCG vaccine in Reducing the Incidence and severity of COVID-19 in the high-risk population | To evaluate efficacy of Bacillus Calmette-Guerin (BCG) in Reducing the Incidence and severity of COVID-19 in the high-risk population (BRIC): a phase III, Multicentric, Quadruple blind Randomized controlled trial | | Indian Council of Medical Research | 18-07-2020 | 20200718 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45677 | Not Recruiting | No | | | | 05-08-2020 | 800 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | N/A | India→ | Dr Sanjeev Sinha→ | | Third floor, RN 17, SRB wing, Department of Medicine, Ansari Nagar, AIIMS, New Delhi E-61, Ansari Nagar, East,
AIIMS, New Delhi-110029→ | drsanjeevsinha@gmail.com→ | 9810164416→ | All India Institute of Medical Science→ | Inclusion criteria: I. High-risk groups which include: adults (Male and female â?¥18 to 60 years) with underlying medical conditions, particularly if not well controlled, including: <br/ ><br>1. Diabetes mellitus <br/ ><br>2. Chronic kidney disease (both dialysis dependent and independent) <br/ ><br>3. Chronic heart conditions (coronary artery disease and hypertension) <br/ ><br>4. Chronic lung disease (included asthma, COPD and bronchiectasis) <br/ ><br>→ | Exclusion criteria: i. History of allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration <br/ ><br>ii. Any signs or symptoms of COVID-19 within the past 24 hours <br/ ><br>iii. Pregnancy or planning pregnancy <br/ ><br>iv. Breastfeeding <br/ ><br>v. Suspicion of active viral or bacterial infection <br/ ><br>vi. Any Immunocompromised subjects including <br/ ><br>o Human immunodeficiency virus (HIV-1), <br/ ><br>o Neutropenic with less than 1500 neutrophils/mm3, <br/ ><br>o Solid organ or bone marrow transplantation, <br/ ><br>o Chemotherapy or radiotherapy, and <br/ ><br>o Primary immunodeficiency <br/ ><br>vii. Subject on immunosuppressed or taking immunosuppressive drugs <br/ ><br>viii. Documented history of COVID-19 infection <br/ ><br>ix. Active malignancy within the prior two years <br/ ><br>o Active skin disease such as eczema, dermatitis or psoriasis at or near site of vaccination <br/ ><br>o Direct involvement in the design or the execution of the study <br/ ><br>o Not willing to give consent <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Conventional BCG vaccine: Standard COVID-19 preventive practices along with BCG Vaccine. Participants will receive a single dose of BCG vaccine at base line. The adult dose of BCG vaccine is 0.1 mL injected intradermally over the distal insertion of the deltoid muscle in left arm.We will follow them for 9 months.<br>Control Intervention1: Standard COVID-19 preventive practices along with Inj Placebo (saline). Participants will receive a single dose will consist of 0.1 mL saline at baseline.: The adult dose of BCG vaccine is 0.1 mL injected intradermally over the distal insertion of the deltoid muscle in left arm.We will follow them for 9 months.<br>→ | Incidence of COVID-19 by 9 months of follow-up.Timepoint: Incidence of COVID-19 by 9 months of follow-up.→ | | | | Yes | False | | |
| → | CTRI/2020/07/026670 | 27 January 2021 | Role of immune boosting kit in covid disease | Evaluation of prophylactic effect of Ayurvedic interventions in the prevention of COVID-19 infections in susceptible general population: A single arm clinical exploratory study | | All India Institute of Ayurveda | 18-07-2020 | 20200718 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45713 | Not Recruiting | No | | | | 28-07-2020 | 500 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr SISIR KUMAR MANDAL→ | | 303,THIRD FLOOR ,ROG NIDAN DEPARTMENT,ALL INDIA INSTITUTE OF AYURVEDA,NEW DELHI-110076 → | todrskmandal@gmail.com→ | 8697097984→ | ALL INDIA INSTITUTE OF AYURVEDA→ | Inclusion criteria: susceptible general population having risk of exposure to COVID-19 infection from different regions of Delhi→ | Exclusion criteria: all those who are not willing to participate in the study <br/ ><br>age less than 18 years and more than 60 years <br/ ><br>co-morbid condition (diabetes)→ | | Intervention1: chyawanprash avaleha , sanshamani vati,anu tail,ayush kwath: chyawanprash-15gm once in morning with lukewarm milk empty stomach<br>sanshamni vati-500mg twice a day 1/2 hour before meal<br>Anu tail nasya -2 drops per nostrils twice a day<br>Ayush kwath -40ml twice a day after meal<br><br>Control Intervention1: NOT applicable: not applicable<br>→ | To study the efficacy of efficacy of ayurveda interventions in the prevention of COVID -19 infections in susceptible general populationTimepoint: 2 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026671 | 27 January 2021 | Ozone Therapy for Covid 19 patients | A pilot study for treatment of COVID-19 patients in moderate stage using intravenous administration of ozonized saline as an adjuvant treatment | | Bisleri charitable trust | 18-07-2020 | 20200718 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45728 | Not Recruiting | No | | | | 27-07-2020 | 10 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Jignasha Captain→ | | Director-Ozone Forum of India, Clinical Head, 3rd Flr Bisleri Tower Off Western Express Highway, Andheri - Kurla Rd, Mumbai → | drmilishah@gmail.com→ | 9819376454→ | Ozone Forum of India→ | Inclusion criteria: 1. Patients confirmed to be COVID-19 positive by quantitative real time polymerase chain reaction (QRT-PCR) assay <br/ ><br>2. Patients that meet any one of the criteria of moderate stage <br/ ><br>3. Patients who give written informed consent. <br/ ><br>4. Age 18 â?? 65 years→ | Exclusion criteria: 1. Mild or severe stage <br/ ><br>2. G6PD deficiency <br/ ><br>3. Hyperthyroidism <br/ ><br>4. Bleeding disorders (any coagulopathies) <br/ ><br>5. Chronic uncontrolled illnesses such as uncontrolled diabetes, uncontrolled hypertension chronic renal failure, chronic liver disease, chronic neurodegenerative disorders, chronic heart conditions (chronic heart failure, chronic angina, previous <br/ ><br>myocardial infarction), malignancies, etc., <br/ ><br>6. Pregnant and lactating women <br/ ><br>7. Patients on immunosuppressant drugs <br/ ><br>8. Patients with a history of organ transplantation <br/ ><br>9. Patients who are participating in other clinical trials→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ozone therapy: 200 ml ozonized saline will be administered intravenously over 1 hour at 60 drops per minute for 8 days.<br>Control Intervention1: NA: NA<br>→ | a. Time to recovery on 8 point ordinal scale (Time to reach point 6-8) <br/ ><br>b. Time to Resolution of symptoms (Fever, cough, respiratory rate, shortness of <br/ ><br>breath) <br/ ><br>c. PAO2/FiO2 <br/ ><br>d. Chest X-ray â?? Day 1, 7 & 14 <br/ ><br>e. Inflammatory Biomarkers: <br/ ><br>C- reactive Protein,IL-6,Ferritin,LDH, D-Dimer <br/ ><br>e. Percentage of patients declining to serious stage at the end of 14 days <br/ ><br>f. Percentage of patients improving to mild stage at the end of 14 daysTimepoint: Day 1 <br/ ><br>Day 3 <br/ ><br>Day 6 <br/ ><br>Day 10 <br/ ><br>Day 14→ | | | | Yes | False | | |
| → | CTRI/2020/07/026672 | 27 January 2021 | Mental health affected by COVID-19 | Mental health among individuals dealing with COVID-19 | | Tata Memorial Hospital | 18-07-2020 | 20200718 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45764 | Not Recruiting | No | | | | 28-07-2020 | 2000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Afghanistan;Albania;Algeria;Andorra;Angola;Antigua and Barbuda;Argentina;Armenia;Australia;Austria;Azerbaijan;Bahamas;Bahrain;Bangladesh;Barbados;Belarus;Belgium;Belize;Benin;Bhutan;Bolivia;Bosnia and Herzegovina;Botswana;Brazil;Brunei Darussalam;Bulgaria;Burkina Faso;Burundi;Cambodia;Cameroon;Canada;Cape Verde;Central African Republic;Chad;Chile;China;Colombia;Comoros;Congo;Cook Islands;Costa Rica;Cote d'Ivoire;Croatia;Cuba;Cyprus;Czech Republic;Democratic People's Republic of Korea;Democratic Republic of the Congo;Denmark;Djibouti;Dominica;Dominican Republic;Ecuador;Egypt;El Salvador;Equatorial Guinea;Eritrea;Estonia;Ethiopia;Fiji;Finland;France;Gabon;Gambia;Georgia;Germany;Ghana;Greece;Grenada;Guatemala;Guinea;Guinea-Bissau;Guyana;Haiti;Honduras;Hong Kong;Hungary;Iceland;India;Indonesia;Iran (Islamic Republic of);Iraq;Ireland;Israel;Italy;Jamaica;Japan;Jordan;Kazakhstan;Kenya;Kiribati;Kuwait;Kyrgyzstan;Lao People's Democratic Republic;Latvia;Lebanon;Lesotho;Liberia;Libyan Arab Jamahiriya;Lithuania;Luxembourg;Madagascar;Malawi;Malaysia;Maldives;Mali;Malta;Marshall Islands;Mauritania;Mauritius;Mexico;Micronesia (Federated States of);Monaco;Mongolia;Montenegro;Morocco;Mozambique;Myanmar;Namibia;Nauru;Nepal;Netherlands;New Zealand;Nicaragua;Niger;Nigeria;Niue;Norway;Oman;Other;Pakistan;Palau;Panama;Papua New Guinea;Paraguay;Peru;Philippines;Poland;Portugal;Qatar;Republic of Korea;Republic of Moldova;Romania;Russian Federation;Rwanda;Saint Kitts and Nevis;Saint Lucia;Saint Vincent and the Grenadines;Samoa;San Marino;Sao Tome and Principe;Saudi Arabia;Senegal;Serbia ;Seychelles;Sierra Leone;Singapore;Slovakia;Slovenia;Solomon Islands;Somalia;South Africa;Spain;Sri Lanka;Sudan;Suriname;Swaziland;Sweden;Switzerland;Syrian Arab Republic;Taiwan;Tajikistan;Tanzania;Thailand;The former Yugoslav Republic of Macedonia;Timor-Leste;Togo;Tonga;Trinidad and Tobago;Tunisia;Turkey;Turkmenistan;Tuvalu;Uganda;Ukraine;United Arab Emirates;United Kingdom;United Republic of Tanzania;United States of America;Uruguay;Uzbekistan;Vanuatu;Venezuela (Bolivarian Republic of);Viet Nam;Yemen;Zambia;Zimbabwe→ | Arjun Singh→ | | Dr. E Borges Marg, Parel, Mumbai 400012, India Dr. E Borges Marg, Parel, Mumbai 400012, India→ | arjun193@gmail.com→ | | Tata Memorial Hospital→ | Inclusion criteria: 1. Confirmed cases of COVID-19 diagnosed using RT-PCR (real-time reverse transcription polymerase chain reaction) <br/ ><br>2. Healthcare workers and patient relatives dealing with COVID-19 patients <br/ ><br>3. Age between 18-65 years <br/ ><br>→ | Exclusion criteria: 1. Non consenting participants→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | PHQ 9 and/or WHO-BREF scoreTimepoint: Cross sectional at the time of administration of questionnaire→ | | | | Yes | False | | |
| → | CTRI/2020/07/026676 | 27 January 2021 | Psychological Impact of COVID 19 on Pregnant women | Psychological Impact of COVID 19 on Pregnant women | | Dr Harini Atturu | 19-07-2020 | 20200719 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44603 | Not Recruiting | No | | | | 03-08-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Harini Atturu→ | | Department of Psychiatry, 2nd floor, Room No 202,
CARE Hospitals Hitech City
Old Mumbai High way
Near Police Commissionerate
Hitech City → | dr.harini.atturu@carefamily.in→ | 9121009559→ | CARE Hospitals Hitech City→ | Inclusion criteria: Pregnant women of any gestational age→ | Exclusion criteria: Pregnant women who refuse to consent for the study <br/ ><br> <br/ ><br>→ | | | Psychological impactTimepoint: Baseline only. At the time of data collection (once)→ | | | | Yes | False | | |
| → | CTRI/2020/07/026674 | 27 January 2021 | Effect of Ayurveda Spice Mix Tablet for the Prevention of COVID-19 infection in people exposed to Covid 19 and in high risk patients | "Randomized Clinical Trial of Ayurveda Spice Mix Tablet for the Prevention of SARS-CoV-2 Infection (COVID-19) in Healthcare Personnel/High-Risk patientsâ?? | | Suraj Ayurveda Clinic and Research center | 19-07-2020 | 20200719 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45712 | Not Recruiting | No | | | | 27-07-2020 | 130 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 1 | India→ | Dr Manoj Chaudhari→ | | Ashtang Ayurveda Mahavidyalaya Samhita Department 2062 Sadashiv Peth Pune → | drgmarda@gmail.com→ | 9372009589→ | Ashtang Ayurveda Mahavidyalaya→ | Inclusion criteria: 1. Male or female aged 18-75 years <br/ ><br>2. Health care workers/Covid Fighters like police/Social workers etc or high risk group patients in public/private hospitals in India or People in areas of risk of SARS-CoV-2 transmission. <br/ ><br>3. People exposed to Covid 19 or having Contact history in 14 days <br/ ><br>4. Understanding of the aim of the study and, therefore,acknowledging they have not been on any drug aiming atpre exposure prophylaxis against SARS-CoV-2 (COVID-19) since 1st of May 2020 untill 7 days before the study. This also includes drug forHIV. <br/ ><br>5. Negative pregnancy test during the previous 7 days to start treatments or more than 2 years after menopause <br/ ><br>→ | Exclusion criteria: 1. COVID + Ve Patient with Symptoms of pneumonia/Hospitalized <br/ ><br>2. Active hepatitis B infection, HIV infection <br/ ><br>3. Renal failure with estimated glomerular filtration rate (GFR) < 60 ml/min) and patients on Hemodialysis. <br/ ><br>4. Participant with any immunosuppressive condition or hematological disease <br/ ><br>5. Breastfeeding <br/ ><br>6. Known allergy to any of the medication used in this trial <br/ ><br>→ | | Intervention1: Ayurveda Spice Mix tablet: Ayurveda Spice mix (Tulsimmune) 500 mg INGREDIENTS<br>1.Licorice-Glycerrhizaglabra â?? 50mg<br>2.Tulsi-Ocimum sanctum â?? 100 mg<br>3.Ginger â?? Zinzber officinalis 40 mg<br>4.Cinnamon â?? cinnamomum zylenicum 40 mg<br>5.black pepper â?? Piper nigrum 25 mg<br>6.Turmeric â?? Curcuma Longa 25 mg<br>7.Pippali - piper longum 40 mg<br>8.Amalaki â?? Phyllanthus emblica 80 mg<br>9. Guduchi â?? Tinospora cordifolia 100 mg<br><br>The said formulation is FSSAI approved / and under approval of Fda<br><br>Control Intervention1: Standard Prophylactic treatment used as per ICMR: HCQS<br>→ | Reducing number of infected patients in health professionals /workers, Covid fighters like police, social workers etc and people exposed Covid 19 or having history of Contact.Timepoint: day 0, day 14, day 28→ | | | | Yes | False | | |
| → | CTRI/2020/07/026675 | 27 January 2021 | Efficacy of Ayurveda treatment Protocol with Tulsimmune Tablet in Covid 19 | "Randomized controlled Clinical Trial of Ayurveda Treatment Protocol with spice mix tablet (Tulsimmune) for management of SARS-CoV-2 Infection (COVID-19)â??. | | Suraj Ayurveda Clinic and Research center | 19-07-2020 | 20200719 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45731 | Not Recruiting | No | | | | 27-07-2020 | 76 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 1/ Phase 2 | India→ | Dr Akshaya Wagh Dr Pratika Kambale→ | | H.J. Doshi Ghatkopar Hindusabha Hospital Internal Medicine Department Room no 3 Gr. Floor Shradhanand road, opp. Railway station, Ghatkopar-W, Mumbai-4000086 dr.pratika15@gmail.com
8976581567, 9619019880→ | ghanashyam_marda@yahoo.com→ | 9422009589→ | H.J. Doshi Ghatkopar Hindusabha Hospital→ | Inclusion criteria: 1.Age Eligible for Study:18 Years to 75, male female <br/ ><br>2.Subject must meet the WHO/MOHFW India /ICMR Criteria having symptoms of SARS CoV2 described in WHO Report/groups described by MOHFW India, (Group B,C,D,E mainly) <br/ ><br>3.Quarantine/non hospitalized or hospitalized AND Fulfills WHO case definition, including a positive PCR for COVID-19 from any specimen (e.g. respiratory, blood, urine, stool, other bodily fluid) and other analysis. <br/ ><br>→ | Exclusion criteria: 1. Active indication and use for one of the investigational products (e.g. HIV positive or active hepatitis B if antiretroviral agents were used ) <br/ ><br>2. Allergy or other contraindication or one of the investigational products <br/ ><br>3. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ ><br>4. Participant with any immunosuppressive condition or hematological disease <br/ ><br>5. Participation in any other A.S.U and H protocol <br/ ><br>6. Pregnant woman and lactating mother <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayurveda Treatment Protocol With Ayurveda spice mix tablet: Ayurveda Spice mix (Tulsimmune) tablet 500 mg One to two tablets two to three times a day with preferably hot water or chewing orally depend upon severity of patents. In most severe cases Suvarna malini vasant 50 mg to 75 mg will be an add on treatment along with conventional treatment<br>the duration of therapy for each subject - 14 days<br>Control Intervention1: Standard Treatment protocol designed by MOHFW/ICMR like: HCQS 400 mg 1-0-1 (first day)<br>HCQS 200 mg 1-0-1 after Day 1<br>Azithromycin 500 mg 1-0-0<br>Antiviral/Tamiflu 1-0-1<br>and vitamin support<br>→ | Change in the severity index of symptoms of SARS-CoV 2 patients in public/private hospitals in Maharashtra. <br/ ><br>1.Severity of disease in SARS-CoV-2 assessed by <br/ ><br>No symptoms-1 <br/ ><br>Mild symptoms-fever, dry cough, myalgia, fatigue, anosmia-2 <br/ ><br>Moderate symptoms-mild symptoms plus shortness of breath, dyspnoea-3 <br/ ><br>â?¢Severe symptoms-respiratory insufficiency that requires Oxygen support and mechanical ventilation-4 <br/ ><br>2. Duration of symptoms in Patients of SARS-CoV-2 measured in days <br/ ><br>Timepoint: Day 0, day 14→ | | | | Yes | False | | |
| → | CTRI/2020/07/026677 | 27 January 2021 | Role of cough and voice analysis using artificial intelligence in the management of COVID 19 patients | Role of novel non-invasive cardiopulmonary assessments in early detection, triaging and predicting prognosis of COVID 19 patients | | Gnaneswar Atturu | 19-07-2020 | 20200719 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45780 | Not Recruiting | No | | | | 03-08-2020 | 250 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Gnaneswar Atturu→ | | Department of Vascular and Endovascular surgery,
CARE Outpatient block,
Banjara Hills Road No 10, → | dr.gnaneswar.atturu@carefamily.in→ | 7674893748→ | CARE Hospitals→ | Inclusion criteria: 1.Confirmed COVID 19 positive patients (both symptomatic and asymptomatic) <br/ ><br>2.Suspected but not confirmed COVID 19 patients <br/ ><br>3.Contacts of confirmed COVID 19 patients <br/ ><br>4.Persons with previous co-morbidities will also be considered <br/ ><br>→ | Exclusion criteria: 1. Persons who refuse to give consent <br/ ><br>2. Persons who canâ??t cough or record a sentence <br/ ><br>3. Patients who are on ventilator support (at the time of recruitment) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | collecting the necessary acoustic samples from COVID 19 patients and healthy volunteers that can be used to build a machine learning model and understand the acoustic patterns.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026678 | 27 January 2021 | what are the clinical effects in newborns born to mothers exposed to COVID-19 viral infection. | Clinical profile and outcomes in newborns exposed to maternal COVID-19 disease in a tertiary care centre - A cohort study - NeOCoM (Neonatal Outcomes in Covid-19 Mothers) | | Chengalpattu Medical College | 19-07-2020 | 20200719 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45786 | Recruiting | No | | | | 30-07-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr M Anitha→ | | Department of Paediatrics,
Chengalpattu Medical College,
VOC nagar,
Chengalpattu → | drmanithamd@gmail.com→ | 09840652191→ | Chengalpattu Medical College→ | Inclusion criteria: All neonates born in the Department of OBG or admitted for neonatal care to NICU during the study period.→ | Exclusion criteria: 1.Infants born with major congenital anomaly diagnosed or suspected before the exposure to COVID â?? 19 infection. <br/ ><br>2.Parental Refusal of Consent to participate in the study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | Incidence of NICU admission during the neonatal periodTimepoint: 0-30 days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026705 | 27 January 2021 | Efficacy and safety of AYUSH 64 tablets in treating mild to moderate Covid 19 patients | A Randomized, Open Label, Parallel Efficacy, Active Control, Exploratory Clinical Trial to Evaluate Efficacy and Safety of an Ayurvedic Formulation (AYUSH 64) as Adjunct Treatment to Standard of Care for the management of Mild to Moderate COVID-19 Patients | | Central council for research in Ayurveda and Siddha | 20-07-2020 | 20200720 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45088 | Not Recruiting | No | | | | 28-07-2020 | 80 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 1 | India→ | Dr Nataraj H R→ | | B M road
Tanniruhalla
Hassan → | drnatarajhr@sdmcahhassan.org→ | 09844849192→ | Shri Dharmasthala manjunatheshwara college of Ayurveda Hassan→ | Inclusion criteria: 1. Typical clinical presentation of acute onset febrile illness with sore throat and dry cough with or without shortness of breath and a RT_PCR based laboratory confirmation test for COVID-19 <br/ ><br>2. Patients presenting with or without Typical clinical presentation but having RT_PCR based laboratory confirmation test for COVID-19 <br/ ><br>3. Patients with either sex, 18 to 75 years age <br/ ><br>4. Patients with mild-moderately severe disease <br/ ><br>5. All patients must agree not to share medication <br/ ><br>6. Patients willing to participate and sign an informed consent Understands and agrees to comply with planned study procedures. <br/ ><br>7. Agrees to the give OP swabs and venous blood for testing as per protocol <br/ ><br>→ | Exclusion criteria: → | Health Condition 1: B342- Coronavirus infection, unspecified
→ | Intervention1: Group I : (Ayurveda as add-on to standard care as per: guidelines)<br>AYUSH 64<br>Dose 2 capsules (500 mg each) thrice daily<br>Dosage form Capsules/Tablets <br>Route of Administration Oral<br>Time of Administration Thrice a day after food<br>Anupana Water <br>Duration of therapy 1 month<br><br>Control Intervention1: Group-II: <br>Conventional standard therapy as per ICMR/WHO guidelines<br><br>→ | a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery (see criteria below)] <br/ ><br>b) Proportion of patients showing â??clinical recoveryâ?? <br/ ><br>Timepoint: 7-15-30 days <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026698 | 27 January 2021 | COVID 19 and changes in the heart | Spectrum of Cardiovascular manifestations of COVID 19 and creation and Assessment of an artificial intelligence based ECG screening tool for the Diagnosis and prognosis of the disease | | Self | 20-07-2020 | 20200720 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43604 | Not Recruiting | No | | | | 19-05-2020 | 3000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Jayaprakash Shenthar→ | | Room No 9 , First Floor
Professors Chambers ,
Department of Electrophysiology,
9th Block Jaya nagar, Bannerghatta Road, bangalore → | Epsjic@gmail.com→ | | Sri Jayadeva Institute of Cardiovascular Sciences and Research→ | Inclusion criteria: All patients screened for COVID infection→ | Exclusion criteria: Absence of consent <br/ ><br>Patients <18 y of age→ | Health Condition 1: J128- Other viral pneumonia
→ | | 1. Range and extent of conduction tissue abnormalities due to COVID-19 infection at admission , during admission and at discharge . <br/ ><br>2. Attempts for continuous monitoring shall be made since a point evaluation for the patient <br/ ><br>may not be useful given the varying incidence and transient nature of the cardiovascular manifestationsTimepoint: <br/ ><br>The data shall be collected through out the course of admission of admission of the patients and the algorithm shall be created once we have sufficient patient number to create an algorithm using machine learning and deep learning techniques <br/ ><br>Anticipated time period <br/ ><br>1. Day of admission Day 0 <br/ ><br>2. Day of discharge day 14 <br/ ><br>3. Creation of algorithm : 6months after the enrolment of the last patient→ | | | | Yes | False | | |
| → | CTRI/2020/07/026700 | 27 January 2021 | Ayurvedic Rasayana therapies | A randomized placebo controlled multicentric study to evaluate the efficacy and safety of Ayurvedic formulation as an immunomodulator in reducing the risk of COVID 19 infection or severe stage coronavirus disease in Healthcare workers involved in care of patients with Coronavirus disease | | Ayurved Rasayani | 20-07-2020 | 20200720 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45207 | Not Recruiting | No | | | | 27-07-2020 | 200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | N/A | India→ | Dr Avinash Kadam→ | | Depertment of Clinical Resrach
Ayurved Rasayani
Mhalunge Nande Road Mhalunge Padale Tal Mulshi Dist Pune → | avinashk@rbpl.co.in→ | 9970259583→ | Ayurved Rasayani→ | Inclusion criteria: 1 18 years or older <br/ ><br> <br/ ><br>2 If an individual has come in close contact with someone who has been diagnosed with COVID 19 with last exposure within the last 4 days and do not have any symptoms or <br/ ><br>3 A healthcare worker involved in care of patients with Coronavirus disease <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1 Immunocompromised patients or patients receiving immuno-compromised medications <br/ ><br>2 Patients with active malignancy or undergoing anticancer therapies <br/ ><br>3 Pregnant women or women who are breastfeeding <br/ ><br>4 Consideration by the investigator for any reason that the subject is an unsuitable <br/ ><br>5 candidate to receive study treatment <br/ ><br>Patients not willing to participate in study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayurveda formulation: Capsule Pranvir : 2 capsules twice daily with warm water.<br>Capsule Yasada Rasayana: 1 capsule twice daily with warm waterfor 60 days<br>Control Intervention1: Placebo: Placebo similar to Pranvir and Yasada for 60 days<br>→ | To evaluate if Ayurveda Rasayana therapy can prevent symptomatic coronavirus disease or <br/ ><br> severe corona virus disease after known exposure to the SARS-CoV-2 coronavirusTimepoint: Day 1 <br/ ><br>Day 30 and <br/ ><br>Day 60→ | | | | Yes | False | | |
| → | CTRI/2020/07/026701 | 27 January 2021 | Scanning of Lungs, Heart and blood vessels by two different techniques using ultrasound in COVID-19 patients | Comparison of automatic versus manual B lines scoring, left ventricular outflow tract
velocity time integral and inferior vena cava collapsibility index in COVID-19 patients. | | Narayana Health | 20-07-2020 | 20200720 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44985 | Not Recruiting | No | | | | 23-07-2020 | 80 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India→ | Dr Muralidhar Kanchi→ | | Department of Anaesthesia
First floor
Narayana Institute of Cardiac Sciences
Narayana Health City
258A
Bommasandra Industrial Area
Anekal Taluk
Bangalore Department of Anaesthesia
First floor
Narayana Institute of Cardiac Sciences
Narayana Health City
25→ | muralidhar.kanchi.dr@narayanahealth.org→ | 080-71222689→ | Narayana Health→ | Inclusion criteria: All adult patients of both sex of age > 18 years, who is diagnosed or suspected to be a Covid-19 undergoing treatment in the hospital. It includes the patients with co-morbities.→ | Exclusion criteria: Pediatric patients (Age < 18 years), psychiatric patients, patients who are not willing to give consent for the study will be excluded from study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To test the agreement between manual and artificial intelligence based B lines scoring system, velocity time integral of left ventricular outflow tract and inferior vena cava collapsibility index in COVID-19 patients.Timepoint: Baseline, 24 hours→ | | 01/09/2020 | | Yes | False | | |
| → | CTRI/2020/07/026714 | 27 January 2021 | Psychological Impact of COVID 19 on Healthcare Workers | Psychological Impact of COVID 19 on Healthcare Workers (Doctors and Nurses) | | Dr Harini Atturu | 21-07-2020 | 20200721 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44848 | Not Recruiting | No | | | | 03-08-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Harini Atturu→ | | Department of Psychiatry, 2nd floor, Room No 202,
CARE Hospitals Hitech City
Old Mumbai High way
Near Police Commissionerate
Hitech City
→ | dr.harini.atturu@carefamily.in→ | 9121009559→ | CARE Hospitals Hitech City→ | Inclusion criteria: 1. All Qualified doctors (minimum of MBBS) <br/ ><br>2. All Qualified nurses (minimum of GNM) <br/ ><br>3. Working in India→ | Exclusion criteria: 1. Currently not practicing in India <br/ ><br>2. Currently not in practice <br/ ><br>→ | | | Psychological impact of COVIDTimepoint: At base line, <br/ ><br>6 months and at <br/ ><br>1 year→ | | | | Yes | False | | |
| → | CTRI/2020/07/026728 | 27 January 2021 | Knowledge,Attitude,and Practice towards COVID-19 among Kerala Residents during the outbreak period:an online cross sectional survey. | Knowledge,Attitude,and Practice(KAP)study towards Corona virus disease2019(COVID-19) among Kerala residents during the outbreak period :an online cross sectional survey. | | Not applicable | 21-07-2020 | 20200721 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45408 | Not Recruiting | No | | | | 01-08-2020 | 140 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | DR Venugopalan AK→ | | Dept. of Community Medicine
Govt.Medical College Kannur
Po. Pariyaram medical college
Dist. Kannur Yodha Thayineri
Po. Payyanur
Dist. Kannur670307→ | kalarivenu@gmail.com→ | 9446168325→ | Govt.Medical College Kanur→ | Inclusion criteria: People aged above 18 years and those who can read and understand malayalam language→ | Exclusion criteria: Not willing to participate→ | | | To assess the Knowledge attitude and practice of community towards COVID-19Timepoint: 1→ | | | | Yes | False | | |
| → | CTRI/2020/07/026715 | 27 January 2021 | Structured online training program on specific COVID-19 Airway Management | Preparedness to combat COVID-19 via structured online training program on Airway Management | | AIIMS Rishikesh | 21-07-2020 | 20200721 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45798 | Not Recruiting | No | | | | 31-07-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Bhavna Gupta→ | | Department of anesthesiology
AIIMS
Rishikesh → | bhavna.kakkar@gmail.com→ | | All India Insttute of Medical Sciences, Rishikesh→ | Inclusion criteria: For each training session, the participants list will be prepared taking homogenous block sample from each clinical department.→ | Exclusion criteria: Those who will not be able to attend the program due to ongoing commitments, or illness during the allotted time will be excluded for that session. However they will be subsequently trained in the next possible session.→ | | Intervention1: none: none<br>→ | The primary outcome variable will include a pre- and post-test questionnaire, developed specifically for the course. The OSCE will also be evaluated as other outcome.Timepoint: at starting and end of course→ | | | | Yes | False | | |
| → | CTRI/2020/07/026757 | 27 January 2021 | An interventional study to access the effect of Homoeopathic medicine in positive cases of COVID-19. | A prospective double blind randomised controlled trial of Eupatorium perfoliatum 30 C in asymptomatic and mild symptomatic cases of COVID-19. | | Ministry of AYUSH | 23-07-2020 | 20200723 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45824 | Not Recruiting | No | | | | 31-07-2020 | 200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3 | India→ | Dr Tapan Nath→ | | Department of Case Taking and Repertory College of Homoeopathy Room no 24 NEIAH Mawdiangdiang
near police outpost
East Khasi Hills → | tapanbngn@gmail.com→ | 8837349308→ | North Eastern Institute of Ayurveda and Homoeopathy (NEIAH)→ | Inclusion criteria: 1. Subjects testing positive for SARS CoV-2 by RT-PCR, presenting with no symptoms or mild symptoms. <br/ ><br>2. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study.→ | Exclusion criteria: 1. Cases of COVID-19 with clinical severity ranging from moderate to critical. <br/ ><br>2. Pregnant and lactating females. <br/ ><br>3. Subjects having uncontrolled and unstable co morbidity. <br/ ><br>4. Immunocompromised subjects or those taking any kind of immunosupressive therapy. <br/ ><br>5. COVIC-19 positive cases participating as subjects in other COVID-19 clinical trails. <br/ ><br>6. Subjects having past history of allergy to any medicine that is part of the Homoeopathic intervention. Other conditions, which in the opinion of the investigator, makes the patient unsuitable for enrollment or could interfere with his participation in, and completion of the protocol.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Eupatorium perfoliatum 30 C: Eupatorium perfoliatum 30 C twice Daily for 5 consecutive days in empty stomach orally. One adult dose is 4 globules of no. 20 medicated globule. One child dose is 2 globules of no. 20 medicated globule. Total duration of intervention is five days.<br>Control Intervention1: Placebo: Number 20 sugar gloubles will be used as placebo in the control arm<br>→ | To assess the effectiveness of Homoeopathic medicine Eupatorium perfoliatum 30 C in preventing the progression of severity of the disease in the SARS-Cov-2 tested positive asymptomatic and mild cases of COVID-19.Timepoint: 3 month→ | | | | Yes | False | | |
| → | CTRI/2020/07/026758 | 27 January 2021 | Knowledge Attitude and Practice of Nurses towards Hand hygiene in COVID-19 care units | Knowledge Attitude and Practice of Nurses towards Hand hygiene in COVID-19 care units in a tertiary care Hospital North Kerala | | No sponsor | 23-07-2020 | 20200723 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45877 | Not Recruiting | No | | | | 10-08-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Venugopalan A K→ | | Dept of Community Medicine
Govt Medical College Kannur
Po Pariyaram Medical College
Dist Kannur Kerala state
→ | kalarivenu@gmail.com→ | 9446168325→ | Govt Medical college Kannur→ | Inclusion criteria: All nurses working at Govt Medical College Kannur who are willing to participate in the study→ | Exclusion criteria: Not willing to participate→ | | | To assess the Knowledge Attitue and Practice of hand hygiene among NursesTimepoint: 1→ | | | | Yes | False | | |
| → | CTRI/2020/07/026759 | 27 January 2021 | Detection of Antibodies to COVID-19 | Evaluation and Validation of the clinical performance of VITROS Anti SARS COV2 Total assay in the COVID-19 patient population and commercialization of the Assay on VITROS 3600 | | Ortho Clinical Diagnostics | 23-07-2020 | 20200723 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45882 | Not Recruiting | No | | | | 03-08-2020 | 175 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Smita Sarma→ | | Department of Laboratory Medicine, Medanta- The Medicity, Gurgaon → | smita.sarma@medanta.org→ | 9868723089→ | Medanta- The Medicity→ | Inclusion criteria: Covid 19 RT PCR positive patients having typical symptoms for about a minimum of 8 days will be assayed using VITROS® CoV2T assay in VITROS® 3600 or 5600 systems. <br/ ><br> <br/ ><br>Asymptomatic health care professionals, will be tested using VITROS® Anti SARS CoV2 Total assay on the VITROS® 3600 Immunodiagnostics or VITROS® 5600 Integrated System. <br/ ><br> <br/ ><br>Samples from normal healthy adult asymptomatic individuals (collected before Nov., 2019) will be tested using VITROS® Anti SARS CoV2 Total assay on the VITROS® 3600 Immunodiagnostics or VITROS® 5600 Integrated System.→ | Exclusion criteria: Exclude samples from patients for whom the time between symptom onset and collection of samples cannot be determined. <br/ ><br> <br/ ><br>Exclude grossly hemolyzed, icteric or turbid samples, or samples with visible particulates that are not getting removed even after centrifugation.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Identifying individuals with an adaptive immune response to SARS-CoV-2 infection.Timepoint: Covid 19 RT PCR positive patients having typical symptoms for about a minimum of 8 days will be assayed. Titres at 8th day will be considered as baseline data→ | | | | Yes | False | | |
| → | CTRI/2020/07/026755 | 27 January 2021 | Clinical severity and outcome among covid-19 infected patients in respect to viral load and immune & inflammatory response. | Correlation of virus load, host factors, clinical severity and outcomes among Covid-19 infected patients: A Controlled Study | | RUHS College of Medical Sciences | 23-07-2020 | 20200723 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44619 | Not Recruiting | No | | | | 27-07-2020 | 200 | Observational | Non-randomized, Placebo Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sonali Sharma→ | | Dept of Biochemisry, sector 11,kumbha marg,pratap nagar,tonk road Sector 18,kumbha marg,pratap nagar,tonk road→ | sonalisharma14@gmail.com→ | 09414314678→ | RUHS College of Medical Sciences→ | Inclusion criteria: All COVID-19 Positive patients admitted in Hospital→ | Exclusion criteria: Non-COVID with other Co-morbidity→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | to identify differences in immunological and biochemical responses in COVID-19 PatientsTimepoint: Immunological and inflammatory response will be assessed on Day 0, Day 5 and Day 10 in covid infected patients and at Day 0 and Day 10 in control patients.→ | | | | Yes | False | | |
| → | CTRI/2020/07/026747 | 27 January 2021 | In this study selenium levels would be determined in both normal volunteers as well as patients suffering from COVID-19. | Determination of Selenium status in Normal subjects and COVID-19 patients; An exploratory study. | | Sami Labs Limited | 23-07-2020 | 20200723 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45446 | Not Recruiting | No | | | | 24-07-2020 | 60 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Kalpesh Shah→ | | 19/1 & 19/2, I Main, II Phase, Peenya Industrial Area → | kalpesh@clinworld.org→ | 08028397973→ | ClinWorld Private Limited→ | Inclusion criteria: A) APPLICABLE FOR NORMAL SUBJECTS <br/ ><br>1 Adult male and female between 18 to 45 years of age. <br/ ><br>2 For normal subjects who currently have no signs and symptoms of any viral/bacterial infection; Body temperature between 97º to 99º F and SpO2 > 90%. <br/ ><br>3 Literate subject willing to give signed informed consent. <br/ ><br> <br/ ><br>B) APPLICABLE FOR COVIDâ??19 SUBJECTS <br/ ><br>1 Adult male and female between 18 to 45 years of age. <br/ ><br>2 Confirmed COVID-19 (SARS-CoV-2 ) infection by nasopharyngeal swab RT-PCR test on the same day. <br/ ><br>3 COVID-19 patients in stable condition with fever, dyspnea without hypoxemia. <br/ ><br>4 Literate subject willing to give signed informed consent.→ | Exclusion criteria: A) APPLICABLE FOR NORMAL SUBJECTS <br/ ><br>1 Patients participation in any another study including macro/micro/any other forms of dietary supplements/multivitamins or disease specific oral nutrition supplements. <br/ ><br>2 Any other condition which the principal investigator thinks may jeopardize the safety of subjects. <br/ ><br> <br/ ><br>B) APPLICABLE FOR COVID -19 PATIENTS <br/ ><br>1 Asymptomatic COVID-19 positive patients. <br/ ><br>2 On Tube feeding or parenteral nutrition. <br/ ><br>3 Admission to isolation ward > 24hrs of confirmed COVID-19 positive test. <br/ ><br>4 Patients on ventilator support. <br/ ><br>5 Patients whose condition is unstable. <br/ ><br>6 Patients participation in any another study including macro/micro/any other forms of dietary supplements/multivitamins or disease specific oral nutrition supplements. <br/ ><br>7 Any other condition which the principal investigator thinks may jeopardize the safety of subjects.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>Control Intervention2: NIL: NIL<br>→ | 1 To analyze the selenium levels in blood and urine of symptomatic COVID-19 positive patients and normal adult subjects. <br/ ><br> <br/ ><br>2 To compare the mean selenium levels in blood and urine of COVID-19 positive patients and normal adult subjects.Timepoint: 1 Selenium levels in blood and urine of symptomatic COVID-19 positive and normal adult subjects (Post enrolment). <br/ ><br> <br/ ><br>2 Mean selenium level comparison in blood and urine of COVID-19 positive and normal adult subjects (Post enrolment).→ | | | | Yes | False | | |
| → | CTRI/2020/07/026756 | 27 January 2021 | Ayurveda strength and immunity enhancing protocol and immunity in health care workers : Clinical trial of an Ayurveda Intervention | Evaluation of the efficacy of Ayurveda drugs for enhancing overall strength and immunity in health care workers of All India Institute Of Ayurveda - An exploratory clinical study | | All India Institute Of Ayurveda | 23-07-2020 | 20200723 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45755 | Not Recruiting | No | | | | 28-07-2020 | 425 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Santosh Kumar Bhatted→ | | Department of Panchakarma , 7th Floor , Academic Building , All India Institute Of Ayurveda , Mathura Road , Gautampuri , Sarita Vihar ,New Delhi All India Institute Of Ayurveda , Mathura Road , Gautampuri , Sarita Vihar ,New Delhi→ | santoshbhatted@rediffmail.com→ | 9414048459→ | All India Institute Of Ayurveda→ | Inclusion criteria: 1. Patients of either sex aged 19-60 years <br/ ><br>2. Only willing staff of AIIA having risk of exposure to COVID-19 infection. <br/ ><br>3. Agrees not to self-medicate with chloroquine, hydroxychloroquine or other potential antivirals. <br/ ><br>4. Individuals agree to give consent for participation <br/ ><br>→ | Exclusion criteria: 1. Individuals with chronic comorbid conditions which has affected the Bala of the Individual. <br/ ><br>2. Already suffering with severe respiratory allergies and other conditions which may create bias in the outcome results <br/ ><br>3. Individuals found positive for COVID 19 during the course of medication. Defined as: temperature > 38 Celsius; cough; shortness of breath; sore throat; or, if available (not required), positive confirmatory testing for COVID-19 <br/ ><br>4. Previously diagnosed with COVID-19 <br/ ><br>5. Subjects on other prophylactic medications. <br/ ><br>6. Concurrent condition that in the investigatorâ??s opinion would jeopardize compliance with the protocol. <br/ ><br>→ | | Intervention1: 1)Tab Shanshamni Vati <br>2)Ayush Kadha <br>3)Chyavanprash <br>4)Anu Taila <br>5)Gargle with warm water mixed with rock salt and turmeric <br>6)Ayush Preventive guidelines for COVID 19 with Yoga and Pranayama <br>All above treatment will be given for 60 days with a <br>Follow up period of 60 days: 1) Tab Shanshamni Vati 250 mg 2 bid after food with warm water <br>2) AYUSH Kadha 40ml bd empty stomach <br>3)Chyavanprash 3gms in morning once a day <br>4)Application Of Anu Taila 2 drops in each nostril once a day after bath in morning <br>5) Gargle with warm water mixed with rock salt and turmeric <br>6) AYUSH preventive guidelines for COVID 19 with Yoga and Pranayama <br>All above treatment will be given for 60 days with a <br>Follow up period of 60 days<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | 1 Improvement in Bala of an individual <br/ ><br>2 Immuno-stimulation leading to non-development of symptoms of COVID- 19 in risk population working in Hospital set up. <br/ ><br>Timepoint: <br/ ><br>4 Assessments at a gap of 30 days <br/ ><br>Baseline 0 <br/ ><br>Assessment 1 <br/ ><br>Assessment 2 <br/ ><br>Assessment 3 <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026791 | 27 January 2021 | Statin and Aspirin in SARS-CoV-2 infection | A Randomised Control Trial of Statin and Aspirin as Adjuvant Therapy in Patients with SARS-CoV-2 Infection (RESIST Trial) - RESIST Trial | | Dr Deepti Siddharthan | 25-07-2020 | 20200725 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44814 | Recruiting | No | | | | 01-08-2020 | 800 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Deepti Siddharthan→ | | Department of Cardiology, CNC building (7th floor)
All India Institute of Medical Sciences (AIIMS), New Delhi
→ | deeptikailath@gmail.com→ | | All India Institute of Medical Sciences (AIIMS), New Delhi→ | Inclusion criteria: 1) RT-PCR positive for SARS-CoV-19 infection, <br/ ><br>2)Symptoms (WHO clinical improvement ordinal score 3 to 5) requiring hospital admission, <br/ ><br>3)Consenting to participate for the trial. <br/ ><br>→ | Exclusion criteria: 1) Critical illness with WHO clinical improvement ordinal score >5, <br/ ><br>2) Documented significant liver disease / dysfunction (AST/ALT > 240), <br/ ><br>3) Myopathy and Rhabdomyolysis (CPK > 5x normal), <br/ ><br>4) Allergy or intolerance to statins, <br/ ><br>5) Allergy or intolerance to aspirin, <br/ ><br>6) Patients taking the following medications: cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor, telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole) clarithromycin and colchicine, <br/ ><br>7) Prior statin use (within 30 days), <br/ ><br>8) Prior aspirin use (within 30 days), <br/ ><br>9) History of active GI bleeding in past three months, <br/ ><br>10)Coagulopathy, <br/ ><br>11)Thrombocytopenia (Platelet count < 100000/ dl), <br/ ><br>12)Pregnancy, active breast-feeding, <br/ ><br>13)Patient unable to take oral or nasogastric medications. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Atorvastatin (Statin): Tablet Atorvastatin 40mg once daily for ten days or till discharge whichever is later<br>Intervention2: Aspirin: Tablet Aspirin 75mg once daily for ten days or till discharge whichever is later.<br>Control Intervention1: Conventional therapy: Conventional therapy for COVID-19 infected patients<br>→ | Clinical deterioration characterised by progression to WHO clinical improvement ordinal score more than or equal to 6 (i.e., endotracheal intubation, non-invasive mechanical ventilation, pressor agents, RRT, ECMO, and mortality).Timepoint: 10 days or until discharge whichever is longer→ | | | | Yes | False | | |
| → | CTRI/2020/07/026798 | 27 January 2021 | Depression, Anxiety and
Stress among healthcare workers during the curved 19 pandemic | Prevalence and Correlates of Depression,Anxiety and Stress among health care workers during COVID-19 pandemic | | DrRidhima Sharma | 25-07-2020 | 20200725 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45852 | Not Recruiting | No | | | | 03-08-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ridhima Sharma→ | | Department of Paediatric anaesthesia Second floor
Room no 3
Super Speciality Paediatric Hospital and Post Graduate Teaching Institute Noida sec 30 Department of Paediatric anaesthesia Second floor
Room no 3
Super Speciality Paediatric Hospital and Post → | drridhimasharma@yahoo.com→ | 08054549458→ | Super Speciality Paediatric Hospital and Post Graduate Teaching Institute→ | Inclusion criteria: The outbreak of the COVID-19 virus pandemic has taxed an unrivalled psychological stress substantially affecting the medical health care workers. However, there is a definitive lack of an evidence-based assessment and mental health attributes in the front-line health workers. To notify this gap, the current study was performed to evaluate the prevalence of depression, stress and anxiety among the health care workers and its correlation with various factors. <br/ ><br>Methods: The current cross-sectional study was conducted in 200 HCW in our tertiary care center. The primary outcomes were to compare the prevalence of depression, anxiety and stress among the health care workers. Thereafter we used multivariate regression to determine the factors correlated to either depression, anxiety or stress. The secondary outcome was to compare DASS (depression, anxiety, stress) between the first line worker and the second line worker and other commonly associated factors responsible for increased DASS-21 scores. <br/ ><br>→ | Exclusion criteria: Healthcare workers who were not willing to participate or already have clinically diagnosed depression anxiety or any other mental illness were excluded from the study→ | | | The Primary outcome were to compare the prevalence of depression, anxiety and stress among the health care workers and administrative staff. Thereafter we used multivariate regression to determine the factors correlated to either depression, anxiety or stress. <br/ ><br>The secondary outcome was to compare DAS between the first line worker and the second line worker and multiple factors attributing to increased DAS were noted. <br/ ><br>Timepoint: 1 week <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026796 | 27 January 2021 | A trial to evaluate the effect of cotton face-masks and other behavioral factors on COVID-19 risk in rural Telangana | Effect of cotton face-masks and other behavioral and health-related risk factors on COVID-19 incidence and severity: Pragmatic cluster-randomized trial and nested observational study in 45 villages in Telangana | | National Institute of Nutrition | 25-07-2020 | 20200725 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45868 | Not Recruiting | No | | | | 03-08-2020 | 10000 | Interventional | Cluster Randomized Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | N/A | India→ | Bharati Kulkarni→ | | Clinical Division,
National Institute of Nutrition,
Osmania University PO, Tarnaka, Hyderabad → | dr.bharatikulkarni@gmail.com→ | 914027197256→ | National Institute of Nutrition→ | Inclusion criteria: All adults above 18 years of age will be eligible.→ | Exclusion criteria: Village level: If a face mask intervention is ongoing in a village or village leaders decline to give permission <br/ ><br>Individual level: Seriously/ terminally ill patients, chronic lung conditions and mentally challenged patients will be excluded from the study.→ | | Intervention1: Cloth Mask: Two masks per individual will be provided to the participants of intervention village<br>Control Intervention1: No intervention: Nil<br>→ | Village-level incidence of COVID-19Timepoint: weekly upto 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026792 | 27 January 2021 | Affect in surgical care in children due to COVID 19 in India: a online survey of surgeons | Online survey on Impact of Covid -19 pandemic on delivery of pediatric surgical care in India. | | Niyaz Khan | 25-07-2020 | 20200725 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45616 | Not Recruiting | No | | | | 30-07-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Niyaz Khan→ | | Department of Pediatric Surgery,
Chacha Nehru Bal Chikitsalaya
Geeta Colony → | khanniyaz82@yahoo.in→ | 9650931486→ | Chacha Nehru Bal Chikitsalaya→ | Inclusion criteria: All practising pediatric surgeons→ | Exclusion criteria: → | | | Impact of COVID 19 on pediatric surgery practiseTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/07/026789 | 27 January 2021 | A clinical study to see effect of ArtemiC in patients with COVID-19 | A Phase II, controlled clinical study designed to evaluate the effect of ArtemiC in patients diagnosed with COVID-19 - ArtemiC | | MGC Pharmaceuticals Ltd | 25-07-2020 | 20200725 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45111 | Not Recruiting | No | | | | 31-07-2020 | 50 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | Dr Neeta Nargundkar→ | | Office No. 02, 03 & 04, 2nd Floor Highland Corporate Center,
Kapurbawdi Junction,
Thane
MAHARASHTRA → | drneeta@biospherecro.com→ | 02241006794→ | Biosphere Clinical Research Pvt.Ltd→ | Inclusion criteria: 1. Confirmed SARS-CoV-2 infection. <br/ ><br>2. Hospitalized patient with COVID-19 of moderate stable or worsening severity not requiring ICU admission, and on the other hand not experiencing clinical improvement under ongoing standard care. <br/ ><br>3. Age: 18 years old and above. <br/ ><br>4. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient). <br/ ><br>5. Ability to receive treatment by spray into the oral cavity→ | Exclusion criteria: 1. Tube feeding or parenteral nutrition. <br/ ><br>2. Oxygen requirements beyond use of nozzles or simple mask as per score 4 <br/ ><br>3. Respiratory decompensation requiring mechanical ventilation. <br/ ><br>4. Uncontrolled diabetes type 2. <br/ ><br>5. Autoimmune disease. <br/ ><br>6. Pregnant or lactating women. <br/ ><br>7. Need for admission to ICU in the course of the present hospitalization at any time prior to completion of the recruitment to the study. <br/ ><br>8. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ArtemiC medical spray: ArtemiC is a Oromucosal medical spray combined of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (15 mg/ml) and vitamin C (60 mg/ml) in spray administration.<br>given as add-on therapy, 2 times a day, on Days 1 and 2.Each dose contains 1ml (10 puffs-pushes on the spray bottle) , total daily dose 2ml (20 puffs- pushes on the spray bottle).The total treatment is 40 puffs for 2 days.<br>Control Intervention1: Placebo: Placebo is a Oromucosal medical spray will be given as add-on therapy, 2 times a day, on Days 1 and 2.<br>Each dose contains 1ml (10 puffs-pushes on the spray bottle) , total daily dose 2ml (20 puffs- pushes on the spray bottle).The total treatment is 40 puffs for 2 days.<br>→ | 1.Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of â?¤ 2 Maintained for 24 Hours in comparison to routine treatment <br/ ><br>2.Percentage of participants with definite or probable drug related adverse eventsTimepoint: 15 Days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026797 | 27 January 2021 | An observational study of lying down flat on chest in treatment of corona patient who breath on their own and on oxygen therapy. | Prone positioning in management of spontaneously breathing non intubated covid19 patient on oxygen therapy - A Prospective observational study. | | New Civil Hospital Surat | 25-07-2020 | 20200725 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45903 | Not Recruiting | No | | | | 02-08-2020 | 111 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Shweta Apatel→ | | Department of Anesthesiology, Government Medical college, surat, New civil Hospital, surat,Opposite Income tax Department Office, Near majura gate, 395001 A-203 , Sanskar park, Ayodhya nagari road, Palanppur patia, Surat.395009→ | shwtpatel730@gmail.com→ | 9825972557→ | Department of Anesthesiology, Government medical college, surat→ | Inclusion criteria: a) Confirmed Covid19 patient with RT-PCR <br/ ><br> <br/ ><br>b) Hospitalized spontaneously breathing, non inubated covid19 patient on Oxygen therapy with NIV or NRBM <br/ ><br> <br/ ><br>c) Age group 18 to 60 years . <br/ ><br>→ | Exclusion criteria: a) Patientâ??s refusal <br/ ><br> <br/ ><br>b) Sign of Respiratory fatigue(RR >40/min, PaCO2 >50 mm hg, PH <7.2) <br/ ><br> <br/ ><br>c) Immediate need for intubation(PaO2/FiO2 <50mm Hg, altered consciousness, unable to protect airway) <br/ ><br> <br/ ><br>d) Hemodynamically unstable patient. <br/ ><br> <br/ ><br>e) Recent abdominal surgery <1 month. <br/ ><br> <br/ ><br>f) Lumber spine lordosis <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J984- Other disorders of lung
→ | | Oxygenation status from spo2 from pulse oximetre and pao2 and fio2 ratio from arterial blood gas analysis.Timepoint: at Baseline(in supine position), <br/ ><br>at 1 hour (after prone position) <br/ ><br>at 3 hour (after prone position) <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026790 | 27 January 2021 | This is the comparative study between two protective boxes which can be used by the doctors while managing critical COVID 19 patients in addition to personal protective equipment. | Comparison of aerosol boxes for intubation in COVID19 patients: a simulation based crossover study | | Dr Ankit Agarwal | 25-07-2020 | 20200725 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45143 | Not Recruiting | No | | | | 03-08-2020 | 21 | Interventional | Randomized, Crossover Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | Dr Mohammad Hashim→ | | Critical Care Unit Level 6 main building AIIMS Rishikesh Veerbhadra Road Rishikesh→ | buxhashim@mail.com→ | 9760171584→ | All India Institute of Medical Sciences, Rishikesh→ | Inclusion criteria: Trained Anesthesiologist with minimum three year experience→ | Exclusion criteria: Not giving Consent→ | | Control Intervention1: Nil: Nil<br>→ | To compare the Intubation time (the time from pass of laryngoscope blade from incisor to first successful breath)Timepoint: 4 days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026800 | 27 January 2021 | A study to campare various blood investigations in COVID-19 positive patients. | Comparison of prognostic value of various Inflammatory markers (Interleukin-6, Procalcitonin, D-Dimer, CRP and Ferritin levels) in COVID-19 positive adult patients in Intensive care units. | | Max Superspeciality Hospital Vaishali | 25-07-2020 | 20200725 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45937 | Recruiting | No | | | | 03-08-2020 | 72 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Dhananjay Batwara→ | | Medical ICU, 7th Floor
Max Superspeciality Hospital Vaishali Sector 1 Ghaziabad→ | dhananjay_batwara@yahoo.com→ | 9099058184→ | Max Superspeciality Hospital Vaishali→ | Inclusion criteria: 1.Adult patients ( >18 years) admitted to the ICU who are RT-PCR confirmed covid-19 positive cases. <br/ ><br>2.Adult patients ( >18 years) admitted to the ICU who are COVID-19 Antigen positive cases.→ | Exclusion criteria: The following will be excluded from the ambit of the study: <br/ ><br>1. Pregnant patients. <br/ ><br>2. When prolonged antibiotic therapy is indicated (e.g., infective endocarditis, tuberculosis etc). <br/ ><br>3. Patients with estimated length of stay less than 24 hours. <br/ ><br>4. Severely immuno compromised patients (e.g., patients with HIV and a CD4 count <200 cells/mm3, neutropenic patients <500neutrophils/mm3 etc), patients with solid organ transplantation. <br/ ><br>5. Patients who are bedridden with chronic multiorgan diseases. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To compare the role of INTERLEUKIN-6, PROCALCITONIN, D-DIMER, CRP and FERRITIN in terms of mortality at 28 days in confirmed covid-19 patients.Timepoint: 28 days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026799 | 27 January 2021 | Yoga for Nurses (COVID-19) | Effect of integrated Yoga on fear, stress, anxiety, sleep and quality of life among nurses working in COVID-19 hospital - COVID-19 | | Sri Devaraj Urs Academy of Higher Education and Research Kolar Karnataka | 25-07-2020 | 20200725 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45964 | Recruiting | No | | | | 04-08-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Outcome Assessor Blinded | Phase 2/ Phase 3 | India→ | Dr Patil NJ→ | | Dept. of Integrative Medicine
Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka → | ayushnitin@gmail.com→ | 9886211008→ | Sri Devaraj Urs Academy of Higher Education and Research Kolar, Karnataka→ | Inclusion criteria: 1.Female nurses working in COVID-19 hospital with minimum 1 month of working history. <br/ ><br> <br/ ><br>2. Age 21 to 50 years <br/ ><br> <br/ ><br>3.Employed at the hospital at least six months <br/ ><br>→ | Exclusion criteria: 1.Pregnancy and lactating mother <br/ ><br> <br/ ><br>2.Practiced Yoga in last 3 months <br/ ><br> <br/ ><br>3.Underwent recent surgery <br/ ><br> <br/ ><br>4. Any other severe illness <br/ ><br>→ | | Intervention1: Integrated Yoga: Group 1 : Integrated Yoga <br>1.Loosening Exercises <br>(Neck movements, Shoulder rotation, Twisting, Forward and backward bending) <br> <br>2.Hand in and out breathing<br>Hand stretch breathing <br> <br>3.Suryanamaskar <br> <br>4.Nadishuddi and Bhramari <br>Pranayama<br><br>5.Deep Relaxation Technique <br><br> <br><br>Control Intervention1: No specific Intervention: No specific Intervention Routine day today activities will carry out<br>→ | Depression, Anxiety, Stress scale-21 (DASS-21) <br/ ><br> <br/ ><br>Fear of COVID-19 scale <br/ ><br> <br/ ><br>Perceived Stress Scale (PSS) <br/ ><br> <br/ ><br>Pittsburgh Sleep Quality Index (PSQI)Timepoint: Day 01 <br/ ><br>Day 42→ | | | | Yes | False | | |
| → | CTRI/2020/07/026793 | 27 January 2021 | Panchgavya Therapy in prophylaxis and as an adjuvant therapy in management of Covid 19. | Prospective, parallel arm, randomized controlled trial to evaluate safety and efficacy of Panchgavya Therapy in prophylaxis and as an adjuvant therapy in management of Covid 19. - Nil | | Ionisation Filtration Industries PvtLtd | 25-07-2020 | 20200725 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45721 | Not Recruiting | No | | | | 31-07-2020 | 120 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2 | India→ | Mr Vivek Joshi→ | | 6 Bansal Capital Bhusari colony Paud Road Pune → | gayatri.mbgindia@gmail.com→ | 855491264→ | Mprex Healthcare Pvt Ltd→ | Inclusion criteria: Patients with RT-PCR confirmed COVID-19 illness. <br/ ><br>Age of 18-65 years of either sex (Both including) <br/ ><br>Mild to Moderate Covid 19 disease (NEWS score NMT 7) <br/ ><br>Signed informed consent. <br/ ><br>Cases with or without presenting with fever and/or upper respiratory tract illness (Influenza-like illness, ILI). <br/ ><br>Subjects at high risk of exposure to COVID 19 <br/ ><br>Health care and frontline workers involved in the treatment of COVID19 cases <br/ ><br>Family members of COVID19 cases or direct contact→ | Exclusion criteria: Subjects with any comorbidity which is critical at the screening <br/ ><br>Allergies, known to be allergic to research drugs <br/ ><br>Confirmed pneumonia cases with or without symptoms <br/ ><br>Patients who have participated in other clinical trials within 1 month <br/ ><br>Proves unfit for the study as a sole discretion of the investigator <br/ ><br>Being pregnant or breastfeeding <br/ ><br>Requiring ICU admission at the screening <br/ ><br>Past History of MI, Epileptic episodes <br/ ><br>Not giving consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Panchgavya Therapy: Ayurcoronil-1- 15 ml BD (after meals) with warm water.<br>Coripel- 2 drops on mask two times a day.<br>Coronoj- Cotton gauge med wet with Coronoj and placed at nostrils for 5 min twice a day. <br>Cowurine Gargle-30 ml warm water 10 ml cow urine will be mixed to gargle thrice a day<br>Cow milk with Goghrita- 60 ml Cow milk (A2 milk) mixed with 10 ml Goghrit to be administered once a day after 3 hrs of first dose of Ayurcoronil-1.<br>This treatment will be followed for single day ie 24 hrs.<br>Control Intervention1: Standard care treatmnet: Standard care treatment should be followed as per ICMR protocol for single day ie 24 hrs.<br>→ | % of subjects with negative RT-PCR for COVID 19 at the end of study <br/ ><br>Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, loss of appetite, fatigue on 5 point ordinal scale-None, mild, moderate, severe , extremely severe <br/ ><br>Clinical status expressed in percentage of subjects reporting each severity rating on a 5-point ordinal scaleTimepoint: 24 hrs. of treatment regimen, patient to be observed daily for till the time of discharge or day 10 whichever is earlier→ | | | | Yes | False | | |
| → | CTRI/2020/07/026788 | 27 January 2021 | A Qualitative study regarding stress and coping in Front-line Health Care Doctors at a tertiary-care hospital. | A qualitative study of stress and coping in health care workers during COVID 19 pandemic at a tertiary referal hospital. | | Department of Psychiatry | 25-07-2020 | 20200725 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44768 | Not Recruiting | No | | | | 17-08-2020 | 20 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Ivan Stanley Netto→ | | Department of Psychiatry,
B.J.Government Medical College,
Pune Department of Psychiatry,
B.J.Government Medical College,
Pune→ | drisnetto@gmail.com→ | 9422081275→ | Indian Psychiatric Society→ | Inclusion criteria: 1.Healthcare workers working in a tertiary referral hospital during Covid 19 pandemic. <br/ ><br>2. Healthcare workers both male and female <br/ ><br>3. Healthcare workers who are willing to consent for the study.→ | Exclusion criteria: 1.Healthcare workers with pre-existing psychiatric disorders.→ | | | Due to the Covid Pandemic there will be increased stress among frontline health care workersTimepoint: The data will be analysed within the next 6 months by 31 st December 2020→ | | | | Yes | False | | |
| → | CTRI/2020/07/026794 | 27 January 2021 | Vitamin-D levels in COVID-19 Patients and their relationship with other bone metabolism markers | Correlation of Vitamin-D levels with markers of Bone Metabolism in COVID-19 Patients | | AIIMS Raipur | 25-07-2020 | 20200725 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45802 | Not Recruiting | No | | | | 03-08-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Alok Chandra Agrawal→ | | Department of Orthopaedics , Room no 10, Orthopaedic OPD , D1 Block , Gate no 4, AIIMS RAIPUR Tatibandh, G E Road Raipur 492099→ | dralokcagrawal@gmail.com→ | 9425151634→ | AIIMS Raipur→ | Inclusion criteria: Consecutive patientsPatients giving voluntary consent for participation in the study. <br/ ><br>→ | Exclusion criteria: Non COVID 19 Patients <br/ ><br>Patients not admitted in COVID 19 ward Patients not giving a consent for the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Does Bone metabolism as judged by serum Calcium, phosphorous, alkaline phosphatase and serum Vitamin D levels get altered in COVID 19 patients?Timepoint: at 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026836 | 27 January 2021 | Effect of COVID - 19 pandemic researchers | A study to assess the Impact of COVID -19 pandemic on the PhD scholars research activities in MAHE, Manipal | | Manipal Academy of Higher Education | 27-07-2020 | 20200727 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45113 | Not Recruiting | No | | | | 10-08-2020 | 1850 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Elsa Sanatombi Devi→ | | Room No 109
Department of Medical Surgical Nursing
Manipal College of Nursing
Manipal Academy of Higher Education Manipal → | elsa.sana@manipal.edu→ | 8310769938→ | Manipal College of Nursing Manipal→ | Inclusion criteria: Research Scholars willing to participate in the study <br/ ><br>Those currently perusing PhD under Manipal Academy of Higher Education <br/ ><br>→ | Exclusion criteria: PhD Scholars (Researchers) outside Manipal Academy of Higher Education <br/ ><br>PhD Scholars who do not give consent for participating in the study <br/ ><br>→ | | | Severity of the impact of COVID 19 pandemic on the researchersTimepoint: one month→ | | | | Yes | False | | |
| → | CTRI/2020/07/026831 | 27 January 2021 | Controlled evaluation of Angiotensin Receptor Blockers for COVID-19
Respiratory Disease
| Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19
Respiratory Disease
- CLARITY | | George Institute for Global Health India | 27-07-2020 | 20200727 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44605 | Not Recruiting | No | | | | 01-08-2020 | 605 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3 | India→ | Professor Vivekanand Jha→ | | 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre New Delhi, India → | vjha@georgeinstitute.org.in→ | 911141588091→ | George Institute for Global Health→ | Inclusion criteria: Potential participants must meet all of the following: <br/ ><br>1. Laboratory-confirmed diagnosis of SARS-CoV-2 infection <br/ ><br>a. Confirmation through appropriate approved laboratory or Point of Care testing method, <br/ ><br>including Polymerase Chain Reaction or other public health assay. <br/ ><br>2. Age greater than or equal to 18 years <br/ ><br>3. Either <br/ ><br>a. Systolic BP (SBP) greater than or equal to 125mmHg <br/ ><br>OR <br/ ><br>b. SBP greater than or equal to 115mmHg and currently treated with a non-RAS inhibitor (RASi) BP-lowering agent <br/ ><br>that can be ceased <br/ ><br>4. Participant and treating staff are willing and able to perform trial procedures. <br/ ><br>5. Intended for admission to a participating hospital for management of COVID-19 <br/ ><br>6. Diagnosis (i.e. date of test result) for SARS-CoV-2 infection must be within 3 days prior to <br/ ><br>randomisation <br/ ><br>→ | Exclusion criteria: Potential participants must not meet any of the following: <br/ ><br>1. Currently treated with an ACEI, ARB or aldosterone antagonist, aliskiren, or angiotensin receptor neprilysin inhibitors (ARNi) <br/ ><br>2.Serum potassium >5.2 mmol/L or no potassium testing within the last 3 months <br/ ><br>3. Estimated Glomerular Filtration Rate (eGFR) less than 30ml/min/1.73m2 or no eGFR testing within the last 3 months, or <br/ ><br>4. Known symptomatic postural hypotension <br/ ><br>5. Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15) <br/ ><br>6. Intolerance of ARB <br/ ><br>7. Women <51 years who are pregnant, have a positive bHCG or are currently breastfeeding <br/ ><br>8. Individuals who are not able to take medications by mouth at enrolment, or who are not expected to be able to take medications by mouth during the first 48 hours after randomisation <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Standard Care plus Angiotensin Receptor Blockers (ARB): Dose: 20 mg to 80 mg. Frequency : Once daily Route of administration: Oral<br>Control Intervention1: Standard Care: Standard Care<br>→ | The primary endpoint is a 7-point NIH Coronavirus Disease 2019 (COVID-19) score, a <br/ ><br>modified version of the 9-point score developed by the WHO for COVID-19 trials. <br/ ><br>Timepoint: The <br/ ><br>ordinal scale is an assessment of the clinical status of the participant at the first <br/ ><br>assessment for the day, measured at Day 28. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026820 | 27 January 2021 | Curcumin for COVID-19 Pre Exposure Prophylaxis | Curcumin for COVID-19 Pre Exposure Prophylaxis: A Randomised Controlled Trail | | Rohit Walia | 27-07-2020 | 20200727 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45936 | Not Recruiting | No | | | | 09-08-2020 | 200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | Phase 4 | India→ | Rohit Walia→ | | Room number 25103 , Department of Cardiology , All India Institute of Medical Science , Rishikesh . → | rwalia7731@yahoo.in→ | 8800492549→ | All India Institute of Medical Science Rishikesh→ | Inclusion criteria: People at risk of SARS-CoV 2 infection ( healthcare professionals , attendants of COVID patients , non COVID patients admitted in hospitals or his risk groups like elderly , cardiovascular patients , diabetes , obesity ) <br/ ><br>Not having a previous COVID19 diagnosis <br/ ><br>Not having experienced COVID19 symptoms since 30 th Jan 2020. <br/ ><br>Not having taken any pre-exposure prophylaxis ( HCQ , any other medication or Ayurvedic preparation or food supplement ) <br/ ><br>Having a negative SARS-CoV 2 test before randomisation→ | Exclusion criteria: Any chronic infection <br/ ><br>Renal failure (CrCl < 60 mL/min/1.73 m2) or need for hemodialysis <br/ ><br>Known history of hypersensitivity to the study drug or any of its components <br/ ><br>Immune suppressant drugs <br/ ><br>Recent vaccination within 2 month <br/ ><br>Pregnancy <br/ ><br>Primary Immunodeficiency states â?¢ Anemia <br/ ><br>Leukopenia <br/ ><br>Thrombocytopenia <br/ ><br>Co morbidities precluding survival required for duration of study follow up <br/ ><br>→ | | Intervention1: Curcumin: Oral Curcumin capsule 500 mg twice daily (morning , evening ) for 12 weeks<br>Control Intervention1: Placebo: Placebo Capsule oral twice daily morning evening for 12 weeks<br>→ | 1. SARS-CoV 2 infection rate Using RTPCRTimepoint: 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/07/026834 | 27 January 2021 | REaCHing to you with listening ears; A friendly telephonic interaction Program for the DDU-GKY members | â??REaCH-Resiliency Engagement and Care in Health; A Telephone Befriending Intervention to address the Psycho-social challenges of vulnerable population in the context of COVID-19 Pandemic: An Exploratory Trial in India" - REaCH | | Director | 27-07-2020 | 20200727 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45953 | Not Recruiting | No | | | | 07-08-2020 | 1480 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Alternation Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Saju M D→ | | Rajagiri P.O
Kalamassery → | saju@rajagiri.edu→ | 9895346190→ | Department of Social Work,Rajagiri College of Social Sciences(Autonomous)→ | Inclusion criteria: 1. Alumina students of the DDU-GKY program, who are either working or are in <br/ ><br>search of a job <br/ ><br>2. Currently enrolled students in the DDU-GKY program <br/ ><br>3. Students aged 18 and above <br/ ><br>4. Own a smartphone?→ | Exclusion criteria: 1. Do not own a smartphone <br/ ><br>2. Unable to operate a smartphone <br/ ><br>3. Less than 18 years of age→ | | Intervention1: Proactive Engagement and Crisis Intervention: In this session the befriender will:<br>â?? Establish a positive and supportive relationship with the participant,<br>â?? Provide emotional support<br>â?? Psycho-education about COVID-19 including precautionary measures,<br>â?? Enquire about general health and biological functioning.<br>Intervention2: Problem-solving oriented supportive therapy: This includes five general stages:<br>â?? Problem orientation, problem definition and<br>formulation, generation of alternatives, decision-<br>making and verification.<br>Intervention3: Assertive linkage with community resources: In this session the befriender will:<br>â?? Provide practical support and information,<br>â?? Emphasize on social support and strategies<br>to improve it will be given,<br>â?? Reassurance to the participant before termination of the session<br>Control Intervention1: 4 General Enquiry Phone calls: It will be a general inquiry about the precautions the participants are taking to<br>protect themselves from the infection, and how the family is coping with the<br>lockdown related issues. The most focus will be given on psycho-education based<br>inquiries on COVID-19, etc.<br>→ | 1. Mental wellbeing measured by World Health Organization-Five Well-being Index <br/ ><br>(WHO-5) <br/ ><br> <br/ ><br> <br/ ><br>2. Depressive symptoms measured by the Patient Health Questionnaire (PHQ-9) <br/ ><br> <br/ ><br>3. Perceived social support measured by the Multidimensional Scale of Perceived <br/ ><br>Social Support (MSPSS-12) (Zimet, Dahlem, Zimet & Farley, 1988)Timepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/07/026837 | 27 January 2021 | Antibody response to COVID-19 in health care workers | A pilot study for prospective evaluation of antibody response in health care workers (HCWs) who had tested positive for SARS-CoV-2 infection | | Ortho Clinical Diagnostics | 27-07-2020 | 20200727 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45957 | Not Recruiting | No | | | | 04-08-2020 | 45 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Smita Sarma→ | | Department of Laboratory Medicine
Clinical Microbiology division
Sector 38
Medanta The Medicity → | smita.sarma@medanta.org→ | 9868723089→ | Medanta- The Medicity→ | Inclusion criteria: At least 45 health care workers with positive RT PCR for COVID will be included in the study→ | Exclusion criteria: Samples that do not have sufficient volume to complete testing on the VITROS <br/ ><br> <br/ ><br>Grossly haemolysed, icteric or turbid samples, or samples with visible particulates that are not getting removed even after centrifugation <br/ ><br> <br/ ><br>Samples which have been subjected to more than two freeze thaw cycles <br/ ><br> <br/ ><br>Samples from patients for whom the time between symptom onset and collection of samples cannot be determined <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Nil<br>→ | To understand the kinetics of antibody development and try to understand theTimepoint: Baseline <br/ ><br>30 days after baseline→ | | | | Yes | False | | |
| → | CTRI/2020/07/026840 | 27 January 2021 | A study to assess the effectiveness of Ayurvedic formulation Guduchi Ghan vati in Covid-19 cases | A Prospective Randomized Controlled Clinical Trial to evaluate the Efficacy and Safety of Guduchi Ghan Vati in the management of COVID-19 infection. | | Directorate of AYUSH Government of Madhya Pradesh | 27-07-2020 | 20200727 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45981 | Not Recruiting | No | | | | 28-07-2020 | 30 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | N/A | India→ | Dr Nitin Ujjaliya→ | | Department of Dravyaguna, Project Division, Room No. 118, First floor, Academic building, Pt. Khushilal Sharma Government Ayurveda College and Institute Bhopal Science Hills, Dhanwantari marg, Behind MANIT, Bhopal MP 462003→ | drvivekkhare@gmail.com→ | 9425649059→ | Pt. Khushilal Sharma Government Ayurveda College and Institute Bhopal→ | Inclusion criteria: Mild to moderate cases registered in the Hospital, <br/ ><br> above 18 years of age, with COVID 2019 (Confirmed by <br/ ><br> RT-PCR) quarantined at identified hospital set up. <br/ ><br> <br/ ><br> Participants who can take medicines orally. <br/ ><br> <br/ ><br> Patients willing to provide signed informed consent. <br/ ><br>→ | Exclusion criteria: Cases of severe vomiting which would make oral administration of medicine difficult. <br/ ><br> <br/ ><br>Cases of respiratory failure and requiring mechanical ventilation. <br/ ><br> <br/ ><br>Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 2 times the upper limit of normal. <br/ ><br> <br/ ><br>Patients with COVID 19 in critical condition or ARDS or NIAD 8 â??point ordinal score 2 Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation <br/ ><br> <br/ ><br>Pregnant or lactating women <br/ ><br> <br/ ><br>Any other condition, which as per the investigator would jeopardize the outcome of the trial. <br/ ><br> <br/ ><br>Withdrawal Criteria: <br/ ><br>a) The participant may be withdrawn from the trial if there is <br/ ><br> <br/ ><br> Any major ailment which necessitating the institution of new modalities of treatment. <br/ ><br> OR <br/ ><br> Non-compliance of the treatment regimen (minimum 80% compliance is essential to continue in the study).→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Guduchi Ghan Vati: Dose: 2 capsule/tablet (250 mg each)<br>Frequency: Twice a day after food.<br>Route: Oral<br>Anupana: Water<br>Duration: 10 days<br>Control Intervention1: Hydroxychloroquine (HCQ): Dose: First day 800 mg<br>maintenance dose for next five days - 400 mg per day.<br>Frequency: Twice a day in divided dosage.<br>Route: Oral<br>Duration: 6 days.<br>→ | Clinical cure rate: Time to negative conversion of severe acute respiratory syndrome corona-virus 2. (From the days of randomization)Timepoint: 5th day, 10th day.→ | | 11/09/2020 | | Yes | False | | |
| → | CTRI/2020/07/026821 | 27 January 2021 | Study of skin, hair and nail changes after COVID 19 illness. | Study of dermatological changes post COVID-19 illness within 3 months of recovery. | | GCS Medical College Hospital Research Centre | 27-07-2020 | 20200727 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45989 | Not Recruiting | No | | | | 24-08-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Nayan H Patel→ | | OPD 35, Department of Dermatology GCS Medical College, Hospital & Research Centre, OPP DRM Office, Near Chamunda Bridge → | patelnayan78.np@gmail.com→ | 9925011309→ | GCS Medical College, Hospital & Research Centre.→ | Inclusion criteria: Any patient treated for COVID-19 in GCSMCH&RC and discharged post recovery. Diagnosis of COVID-19 has to be made with rt-PCR or ICMR guidelines updated at the time of presentation.→ | Exclusion criteria: 1. Any patient not treated at GCSMCH & RC for COVID-19. <br/ ><br>2. Any patient whose documentation of COVID-19 disease course or treatment protocol is not available. <br/ ><br>3. Any patient who was tested SARS-CoV-2 positive without any symptoms and recovered during only home isolation. <br/ ><br>4. Patients presenting more than 3-month past date of recovery(discharge) with skin manifestations. <br/ ><br>5. Any patient developing any new medical, surgical conditions between discharge and development of skin lesions. <br/ ><br>6. Patient who was put on any new medication or change medication regime post discharge for pre-existing conditions will be excluded from study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Dermatological changes in patient recovered from COVID-19 within 3 months of illness.Timepoint: day 0 (baseline day of presentation)→ | | | | Yes | False | | |
| → | CTRI/2020/07/026839 | 27 January 2021 | Study of Shreepad Shree Vallabh SSV Formulation in management of COVID-19 | A randomised double blind trial to evaluate the activity of SSV Formulation for management of SARS-CoV-2 Infection (COVID-19) | | Shreepad Shree Vallabh SSV Phytopharmaceuticals | 27-07-2020 | 20200727 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45994 | Not Recruiting | No | | | | 05-08-2020 | 200 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Dr Yogesh Dound→ | | Medical Department, 201/2, Old Kashmiri Building,
R R Thakur Marg, Majaswadi, Jogeshwari. → | yogesh_dound@yahoo.com→ | 9769057549→ | Shreepad Shree Vallabh SSV Phytopharmaceuticals→ | Inclusion criteria: Quarantine/non hospitalized or hospitalized and fulfils WHO case definition, including a positive RT-PCR confirmed COVID-19 illness. <br/ ><br>Age more than 18 & less than 65 years of either sex. <br/ ><br>Mild to Moderately COVID-19 disease (NEWS score less than or equal to 8). <br/ ><br>Patients with oxygen saturation (SpO2) less than 95%. <br/ ><br>Respiratory rate is more than 20/min. <br/ ><br>Pulse rate more than 90/min. <br/ ><br>Imaging evidence of lung infection in the form of Reticulonodular opacities, ground-glass opacities and consolidation.→ | Exclusion criteria: Pregnant women. <br/ ><br>Breastfeeding women. <br/ ><br>Requiring ICU admission at screening. <br/ ><br>Patients above 65 years of age and below 18 Years. <br/ ><br>Past History of MI, Epileptic episodes. <br/ ><br>Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at screening. <br/ ><br>Asymptomatic patients. <br/ ><br>Patients unwilling for informed consent. <br/ ><br>Patients with prolonged QTc interval on ECG. <br/ ><br>In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ ><br>Participant with any immunosuppressive condition or hematological disease. <br/ ><br>Participation in any other A.S.U and H protocol.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: SSV Formulation Tablets: Each tablet of 500 mg to be consumed orally twice a day immediately after meals for 10 days<br>Control Intervention1: Standard Treatment protocol designed by MOHFW/ICMR: Tab. Hydroxychloroquine (400 mg) BD on 1st day followed by 200 mg BD for 4 days; Azithromycin 500 mg 1-0-0 for 3 days (if needed); and Vitamin support for 10 days<br>→ | Severity of disease in SARS-CoV-2. <br/ ><br> <br/ ><br>Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/ face. <br/ ><br> <br/ ><br>Serum levels of CRP, D-Dimer, Ferritin, IL-6 (At baseline and end of the study as per availability). <br/ ><br> <br/ ><br>Clinical status expressed in percentage of subjects based on Ordinal Scale for Clinical Improvement. <br/ ><br> <br/ ><br>Duration of symptoms in Patients of SARS-CoV-2 measured in days. <br/ ><br>Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 i.e. end of study→ | | 23/09/2020 | | Yes | False | | |
| → | CTRI/2020/07/026835 | 27 January 2021 | Comparison of two different types of simple non-invasive oxygen therapy devices in coronavirus lung infection | Comparison of High Flow Nasal Oxygen and Non Invasive Ventilation in Acute Hypoxemic Respiratory Failure due to Severe COVID-19 pneumonia: A Randomized Controlled Trial | | All India Institute of Medical Sciences New Delhi | 27-07-2020 | 20200727 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44539 | Not Recruiting | No | | | | 27-07-2020 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | Phase 3/ Phase 4 | India→ | Dalim Kumar Baidya→ | | Dept of Anesthesiology, Pain Medicine and Critical Care AIIMS, New Delhi→ | dalimkumar.ab8@gmail.com→ | | AIIMS New Delhi→ | Inclusion criteria: One hundred adult patients (aged between 18 and 75y) with laboratory confirmed diagnosis of COVID-19 pneumonia, presenting with severe COVID-19 pneumonia, who fail oxygen therapy by facemask, will be included in this study after ethics committee approval and informed written consent from the patients or their legally acceptable representatives.→ | Exclusion criteria: Following patients will be excluded <br/ ><br>i) refusal to participate, <br/ ><br>ii) hemodynamically unstable patients on high dose vasopressor therapy <br/ ><br>iii) pregnant patients <br/ ><br>iv) COPD / chronic respiratory failure <br/ ><br>v) Morbid obesity <br/ ><br>vi) Patients with urgent requirement of invasive mechanical ventilation <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | Intervention1: High Flow Nasal Oxygen therapy: Patients allocated to HFNO arm will be applied HFNO through large-bore binasal prongs with a high flow heated humidifier device (Optiflow, Fisher and Paykel Healthcare). The initial gas flow rate will be 50 liters per minute and an FIO2 of 1.0. The flow and FiO2 subsequently adjusted between @ 30 â?? 60L/min and 0.5 -1.0 respectively to maintain SpO2 of 94% or more.<br>Control Intervention1: Non invasive ventilation: Patients allocated to NIV arm will be applied to NIV with either mask/helmet device connected to an ICU ventilator with the setting of PS 10-20 cmH2O adjusted with the aim of obtaining an expired tidal volume of 7 to 10 ml per kilogram of predicted body weight and PEEP 5-10cmH2O titrated to target SpO2 94%.<br>→ | Early intubation rate - Proportion of patients requiring invasive mechanical ventilation at 48 hours of ICU admissionTimepoint: Early intubation rate - Proportion of patients requiring invasive mechanical ventilation at 48 hours of ICU admission→ | | | | Yes | False | | |
| → | CTRI/2020/07/026832 | 27 January 2021 | Artificial intelligence and machine learning for Covid 19 | Computational Identification, Validation and Prediction of COVID 19 using Artificial Intelligence (AI) and Machine Learning (ML) | | Vishweshwairiah Technological University | 27-07-2020 | 20200727 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44797 | Not Recruiting | No | | | | 13-07-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 1 | India→ | Dr Mukesh PR→ | | Department of Aeronautics
ACS Engineering College Bangalore → | vsmprm@gmail.com→ | 7760998700→ | ACS Engineering College→ | Inclusion criteria: Confirmed Positive cases of COVID 19→ | Exclusion criteria: non covid 19 patients→ | Health Condition 1: PCS-
→ | Control Intervention1: NIL: Nil<br>→ | The early identification and prediction is the importance of the proposed project to prevent the spread of disease.From the above literatures it is clearly known that there are no previous studies related to Artificial Intelligence and Machine Learning based short-term forecast of Covid 19 at the initial stage. Hence this research work will be useful for predicting Covid 19 in advanceTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026841 | 27 January 2021 | A clinical trial to study the effects of an Ayurvedic medicine, Haldi 30 ( Turmeric extract ) drops in patients with Corona virus infection. | Efficacy of Ayurvedic Medicine Haldi 30 drops as an Add on medication to standard of care in adult patients of mild to moderate COVID 19. A Phase II randomized, single - blind, parallel group, placebo - controlled trial. | | Dr Sarang Phadke | 28-07-2020 | 20200728 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45659 | Not Recruiting | No | | | | 03-08-2020 | 260 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant Blinded | Phase 2 | India→ | Dr Sarang Phadke→ | | Sahyadri Hospitals Limited Plot no 9 B, Neeta Society, S No 1484 / B, Paud Road, Kothrud,→ | nmission21@yahoo.co.in→ | 9561071607→ | Sahyadri Hospitals Limited→ | Inclusion criteria: COVID 19 positive patients <br/ ><br>1 Mild category <br/ ><br>Group A Asymptomatic but positive for COVID 19. <br/ ><br>Group B Symptomatic URTI without comorbidity. <br/ ><br>Group C Symptomatic URTI with comorbidity. <br/ ><br>2 Moderate category Pneumonia <br/ ><br>hypoxia , fever , cough including SpO2 less than 94 percent Range 90 to 94 percent on room air. Respiratory Rate more or equal to 24 per minute. <br/ ><br>3. Male or non-pregnant female of Age â?¥ 18 years at time of consent. <br/ ><br>4. Women of child bearing potential agree to abstinence or one primary form of non-hormonal contraception during the study period. <br/ ><br>5. Subject / LAR willing to give informed consent for the study and agrees not to participate in another clinical trial for COVID-19 during the course of this study and further agrees to be randomized to any treatment arm of the study.→ | Exclusion criteria: COVID 19 positive patients <br/ ><br>1 Stage II B Group E Pneumonia LRTI with respiratory failure. <br/ ><br>2 Stage III Group F Pneumonia LRTI with respiratory failure multi organ dysfunction syndrome. <br/ ><br>3 Physician makes the decision that trial is not in the best interest of the patient. <br/ ><br>4 Anticipated discharge to another hospital within 72 hours. <br/ ><br>5 Subject already on another trial for COVID-19 <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Standard of care plus Haldi 30 drops: Standard of care plus 3 drops PO at 6 AM, 10 AM, 2 PM, 6 PM, 10 PM.<br>No liquid or solid food or oral medication up to 20 minutes after drug administration.<br><br><br>Control Intervention1: Standard of care plus Sesame oil drops: Standard of care plus 3 drops PO at 6 AM, 10 AM, 2 PM, 6 PM, 10 PM.<br>No liquid or solid food or oral medication up to 20 minutes after drug administration.<br><br>→ | Time to RecoveryTimepoint: Time to Recovery as defined on the Ordinal Scale censured at day 7→ | | | | Yes | False | | |
| → | CTRI/2020/07/026902 | 27 January 2021 | Effect of CRP blood test in management of COVID 19 patients | Impact of CRP test in management of COVID 19 | | GCS Medical College Hospital and Research Centre | 29-07-2020 | 20200729 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45977 | Not Recruiting | No | | | | 05-08-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sachin M Darji→ | | Microbiology Department GCS Medical College Hospital and Research centre Opp DRM Office Near Chamunda Bridge Naroda Ahmedabad → | sachindarji1409@gmail.com→ | | GCS Medical College Hospital and Research Centre→ | Inclusion criteria: All patients presented to GCSMCH AND RC with respiratory symptoms of all age groups→ | Exclusion criteria: Known case of carcinoma <br/ ><br>Known case of Inflammatory bowel disease <br/ ><br>Known case of Arthritis <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | To assess CRP levels in early stage of COVID-19 <br/ ><br>To assess the usefulness of CRP test to predict the risk of clinical deterioration of COVID-19 patients. <br/ ><br>To assess comparison between CRP level and other bio-markers used for COVID-19 patient management. <br/ ><br>To evaluate correlation between CRP levels and case fatality in COVID 19 patients. <br/ ><br>Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/07/026925 | 27 January 2021 | to see the effect of twakadi(tea made up of dalcheeni, tulasi pepper, clove, etc)tea on police worker who have a duty in covid 19 pandemic | Clinical trials to evaluate prophylactic action of Twakadi herbal tea in police professionals working in COVID19 pandemic | | Sterling Multispeciality Hosptal and Ayurved Rugnalay | 30-07-2020 | 20200730 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45587 | Not Recruiting | No | | | | 31-07-2020 | 60 | Interventional | Other<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | Dr Yogini Kulkarni→ | | Department of research College Of Ayurved and Research center Akurdi → | dryoginik01@gmail.com→ | 9822419089→ | CARC Akurdi→ | Inclusion criteria: police professionals working in covid 19 pandemic having age above 25 years irrespective of gender. <br/ ><br>negative for covid 19. <br/ ><br>who are willing to provide signed informed consent→ | Exclusion criteria: pregnant ladies→ | | Intervention1: Twakadi herbal tea: procurement of all herbs(tulasi, Pippali, yashtimadhu, Ginger, Draksha, Dalchini) from authentic sources,(1 cup) authentication of herbs by botanical institutes, standarization of all course powder as per API analysis, tea bag preparation<br>Control Intervention1: use of mask<br>social distancing.<br>: preventive measures regarding covid 19<br>→ | Number Of Participants With Laboratory Confirmed COVID-19 positivity in 14 daysTimepoint: Number of participants with laboratory confirmed COVID-19 positivity in 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026922 | 27 January 2021 | Ayurvedic intervention in COVID-19 patients | An Open Label Single arm Clinical Trial on the effectiveness of Ayurveda interventions in the management of Hospitalized Mild to moderate COVID-19 patients. | | State plan management Unit National Health Mission Uttar Pradesh | 30-07-2020 | 20200730 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45909 | Not Recruiting | No | | | | 04-08-2020 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Adil Rais→ | | Panchakarma Unit
room no 114
LDA Kanpur Road
Lucknow→ | adil.rais13@gmail.com→ | 7060272769→ | Lokbandhu Rajnarayan Combined Hospital→ | Inclusion criteria: Mild to Moderate COVID-19 Positive cases. <br/ ><br>Patients with mild co-morbidities. <br/ ><br>Patients willing to give informed consent.→ | Exclusion criteria: Severe type of COVID-19 Positive cases. <br/ ><br>Patients with severe co-morbidities. <br/ ><br>Patients with Severe Difficulty in breathing. <br/ ><br>Patients willing to give informed consent.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayurveda Drug intervention for 10 days: Vyaghryadi kwatha <br> 50 ml twice a day<br><br>Samshamani Vati <br> 2 tablets 500 mg each twice daily<br>Ashwagandha (Withania somniferum)<br> 2gm in powdered form, once daily with warm water.<br>Rasona Kalka 1gm once daily with warm water.<br><br><br><br><br>Intervention2: biochemical markers: Haemogram, Platelet count, TLC, DLC, Haemoglobin and ESR.<br>Blood Sugar level<br>C-Reactive Protein<br>Liver Function Test<br>Kidney Function Test<br>Ferritin<br>D-Dimer<br>LDH<br>Selected Cytokines: Gamma Interferon, Tumor Necrosis factor (Alpha and Beta), Interleukin-6.<br>Nasal and Throat swab for specific test for COVID 19 based on RT-PCR.<br><br>Control Intervention1: Not applicalble: Not applicable<br>→ | <br/ ><br>To assess role of Ayurvedic Drugs on the immunological markers in Covid 19 patients <br/ ><br> <br/ ><br>Timepoint: 10 days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026954 | 27 January 2021 | Study of blood tests findings in patients of COVID 19 in a tertiary care centre | Hematological parameters in COVID 19 patients - a tertiary care centre experience | | GCS Medical College Hospital and Research Centre | 31-07-2020 | 20200731 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46080 | Not Recruiting | No | | | | 10-08-2020 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Himali Thakkar→ | | Department of Pathology
GCS Medical College Hospital and Research Centre
Opposite DRM Office
Naroda Road. → | himalithakkar281094@gmail.com→ | | GCS Medical College Hospital and Research Centre→ | Inclusion criteria: Patients who tested positive for corona virus and admitted to GCSMCH&RC→ | Exclusion criteria: Patients who tested positive for corona virus but were not admitted in GCSMCH&RC due to any cause. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | To study the demographic characteristics of patients admitted for covid -19 disease. <br/ ><br>To study various hematological parameters like hemogram with indices, total leukocyte count, differential leukocyte count, platelet count and peripheral smear. <br/ ><br>To study the neutrophil- lymphocyte ratio and platelet lymphocyte ratio <br/ ><br>Timepoint: baseline- day 0 <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/07/026955 | 27 January 2021 | What are risk factors associated with disease severity and length of hospital stay in patients admitted with COVID-19 in GCS Medical College, Hospital & Research Centre, Ahmedabad? | Factors associated with disease severity and length of hospital stay in patients with COVID-19 in GCS Medical College, Hospital & Research Centre, Ahmedabad | | Dr Arpit Prajapati | 31-07-2020 | 20200731 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46111 | Not Recruiting | No | | | | 15-08-2020 | 910 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Arpit C Prajapati→ | | room no 5 community Medicine Department third floor GCS Medical College opp DRM office Naroda Road Ahmedabad House no 22 sapphire bungalow near coral bungalow Nana Chiloda Ahmedabad 382330→ | doc.arpitprajapati@gmail.com→ | 9978537231→ | GCS Medical College, Ahmedabad→ | Inclusion criteria: All COVID-19 patients (RT-PCR positive or Antigen Test Positive) admitted at GCS Medical College, Hospital & Research Centre During the April to June 2020→ | Exclusion criteria: Laboratory confirmed negative for COVID-19 by RT-PCR assay→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1.To determine risk factors associated with disease severity <br/ ><br>2.To determine risk factors associated with length of hospital stay in COVID-19 patients <br/ ><br>Timepoint: Primary outcome will be assessed after total sample data entry at 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/07/026943 | 27 January 2021 | Effects of revised COVID19 specific infection control protocol on the well being of dental professionals | Effects of COVID 19 specific infection control protocol on the well being of dental professionals | | DrShruthi Acharya | 31-07-2020 | 20200731 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44582 | Not Recruiting | No | | | | 03-08-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Dr Shruthi Acharya→ | | Manipal College of Dental Sciences,Manipal Academy of Higher Education, Manipal
Karnataka
576104 Department of Oral Medicine and Radiology,Manipal College of Dental Sciences,Madhav Nagar,Manipal, Karnatka-576104→ | shruthi.acharya@gmail.com→ | 919900409822→ | Manipal College of Dental Sciences→ | Inclusion criteria: 1. Dental staff who wear PPE while working at dental hospitals/private clinics <br/ ><br>2. age â?§ 18 years <br/ ><br>3. Voluntary participation <br/ ><br>→ | Exclusion criteria: 1. Dental staff who do not use PPE <br/ ><br> 2. Questionnaires that were incomplete or invalid. <br/ ><br>→ | | | Prevalence of symptoms and conditions affecting skin and headaches due to adherence to infection control protocol <br/ ><br>Timepoint: End of study period→ | | | | Yes | False | | |
| → | CTRI/2020/07/026953 | 27 January 2021 | COMPARISON OF THREE HOMOEOPATHIC DRUGS FOR COVID 19 IMMUNE BOOSTERS AGAINST STANDARD TREATMENT | A Community based
Cluster Randomized Open Level Controlled Field Trial to Evaluate the
Effectiveness of Homoeopathic Prophylaxis and Standard Prophylaxis
against CVOID -19 | | EXTRA MURAL RESEARCH SHCEMEMINISTRY OF AYUSH | 31-07-2020 | 20200731 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45668 | Not Recruiting | No | | | | 03-08-2020 | 704 | Interventional | Cluster Randomized Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | DR PRASANTA RATH→ | | Department of Community Medicine , 6th floor ,Academic Building , National Institute of Homoeopathy , Block- GE , Sector III, Salt Lake Kolkata . QTR NO 2, TYPE IV ,
NIH RESIDENTIAL QTRS ,
JC BLOCK SECTOR III SALT LAKE→ | drprasantarath09@gmail.com→ | 8420924836→ | NATIONAL INSTITUTE OF HOMOEOPATHYBLOCK GE SECTOR III SALT LAKE KOLKATA→ | Inclusion criteria: Adult Male or Female subjects above the age of 18 years to 68 years <br/ ><br>2. Subjects who are from a community where at least 1 confirmed case is already identified. <br/ ><br>3. Subjects who are ready to provide written/digital informed consent and who are willing to <br/ ><br>participate and follow the protocol requirements of the clinical study→ | Exclusion criteria: 1. Pregnant and Lactating females <br/ ><br>2. Known cases of uncontrolled Diabetes and Hypertension. <br/ ><br>3. Subjects having any medical or surgical condition that would require immediate medical or <br/ ><br>surgical intervention at the time of screening <br/ ><br>4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>5. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Subjects participating in any other clinical study or having participated in any other study 1 month <br/ ><br>prior to screening in the present study. <br/ ><br>7. Subjects having a past history of allergy to any medicine that is part of the Homoeopathic <br/ ><br>intervention. <br/ ><br>8. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for <br/ ><br>enrolment or could interfere with his participation in, and completion of the protocol <br/ ><br>9. Patients having heart disease, kidney disease→ | | Intervention1: ARSENICUM ALBUM 30: 4-6 GLOBULES OD FOR THREE DAYS REPEATED AT 15 DAYS INTERVAL FOR 45 DAYS<br>Intervention2: SARCOLACTIC ACID 30: 4-6 GLOBULES OD FOR THREE DAYS<br>REPEATED AT 15 DAYS INTERVAL FOR 45 DAYS<br>Intervention3: CAMPHORA 1M: 4-6 GLOBULES OD FOR THREE DAYS REPEATED AT 15 DAYS INTERVAL FOR 45 DAYS<br>Control Intervention1: Vitamin C 500 MG Tabs AND Zinc Tabs: OD For Three Days at 15 Days Interval For 45 Days<br>→ | Immune Status Questionnaire <br/ ><br>WHO -QOL -BREF QuestionnaireTimepoint: O Days -15 Days- 30 Days -45 Days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026952 | 27 January 2021 | Survey and Management
of depression, Anxiety and Stress due to COVID-19 fear | Survey on depression, anxiety and stress during Covid-19 in general population of Hassan district and its management with Brahmi (Bacopa monnieri (L.) Pennell) - DAS-COVID-19-AYU | | SDM College of Ayurveda and Hospital | 31-07-2020 | 20200731 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45683 | Not Recruiting | No | | | | 01-08-2020 | 200 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Shailaja U→ | | Ayurveda Pediatrics, Room No. 16, SDM Hospital, B.M. Road, Thanniruhalla, Hassan→ | profpnrao@gmail.com→ | 9448064277→ | SDM College of Ayurveda and Hospital, Hassan→ | Inclusion criteria: Subjects within 12 to 60 years of age→ | Exclusion criteria: Subjects below 12 years and above 60 years→ | | Intervention1: Brahmi capsule: Two capsule (500 mg each) twice a day orally<br>Control Intervention1: NIL: NIL<br>→ | Reduction in depression, anxiety and stressTimepoint: 60 days→ | | | | Yes | False | | |
| → | CTRI/2020/07/026942 | 27 January 2021 | Study of COVID 19 suspected pregnant women | Clinical characteristics and obstetric outcome in COVID 19 suspected antenatal patients:A prospective observational study in a tertiary care centre | | Nivedita Hegde | 31-07-2020 | 20200731 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45698 | Not Recruiting | No | | | | 03-08-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Nivedita Hegde→ | | Department of Obstetrics and Gynecology
Kasturba Medical College
Manipal Academy of Higher Education
Manipal → | niveditaashwal@gmail.com→ | 9481306690→ | Kasturba HospitalManipal→ | Inclusion criteria: antenatal and postnatal patients undergoing COVID 19 tests→ | Exclusion criteria: patients who refuse to give consent→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Obstetric outcome of COVID-19 suspected patients and their postnatal management.Timepoint: At Baseline, 1 week, 2 week, 3 week , 4 week, at discharge and after delivery→ | | | | Yes | False | | |
| → | CTRI/2020/07/026926 | 27 January 2021 | Ethics of Behavioral Interventions during the Covid 19 | Perceptions about Ethics of Public Health Behavioral Interventions during the Covid 19 Outbreak | | Forum for Ethical Review Committees in Asia and the western Pacific | 31-07-2020 | 20200731 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45456 | Not Recruiting | No | | | | 31-07-2020 | 400 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | Indonesia;India;Malaysia;Nepal;Philippines;Singapore;Sri Lanka;Thailand→ | Dr Yashashri C Shetty→ | | Demo room 1, Department of Pharmacology and Therapeutics, Seth GS Medical College and KEM Hospital, Acharya Donde marg, Parel, Mumbai. → | yashashrirajit@gmail.com→ | 022-24107517→ | Seth GS Medical College→ | Inclusion criteria: Adults (18 years and above) From each hospital with a functional REC, the following will be recruited to answer the survey questionnaire: 1. REC member â?? 3 persons 2. Healthcare provider/ Researcher - 3 persons 3. Hospital/ university administrator â?? 3 persons 4. Patient and/or family member of patients â?? 3 persons 5. Lawyer and/or public official (works for government) - 3 persons 6. General public and/or community member not affiliated with the hospital â?? 3 persons→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To describe the perception of relevant social sectors about ethics in public health behavioral interventions during the Covid 19 outbreakTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/026956 | 27 January 2021 | Telemedicine effectiveness during COVID-19 | Telemedicine effectiveness during COVID-19 Pandemic-Case study from a tertiary care teaching hospital | | Principal Investigator | 01-08-2020 | 20200801 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46136 | Not Recruiting | No | | | | 10-08-2020 | 463 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Brayal DSouza→ | | Department of Hospital Administration
Prasanna School of Public Health
MAHE, Manipal → | brayal.dsouza@manipal.edu→ | 9900405393→ | Department of Hospital Administration, Prasanna School of Public Health, MAHE, Manipal→ | Inclusion criteria: 1. To assess patterns of utilization of telemedicine at a tertiary care centre <br/ ><br>2. To assess patient satisfaction and with the use of telemedicine <br/ ><br> <br/ ><br>Full enumeration of patients who accessed telemedicine and answered an online survey regarding telemedicine between March to May 2020.→ | Exclusion criteria: No exclusion criteria. <br/ ><br> <br/ ><br>Full enumeration of patients who accessed telemedicine and answered an online survey regarding telemedicine between March to May 2020 will be included.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: Z048- Encounter for examination and observation for other specified reasons
Health Condition 3: Z048- Encounter for examination and observation for other specified reasons
Health Condition 4: Z048- Encounter for examination and observation for other specified reasons
Health Condition 5: Z00-Z99- Factors influencing health status and contact with health services
→ | | The pattern of utilization and patient satisfaction with the care received through telemedicine will be assessed.Timepoint: Data from March to May 2020→ | | | | Yes | False | | |
| → | CTRI/2020/08/026957 | 27 January 2021 | A Clinical trial to evaluate the effect of a combination of treatment of Reginmune capsule and Immunofree tablets in the treatment of mild to moderate COVID-19 patients | An open label, multicenter, randomized, controlled, clinical study to evaluate the efficacy and safety of a combination of treatment of Reginmune capsule and Immunofree tablets compared with standard treatment protocol in the treatment of mild to moderate COVID-19 patients. | | Corival Lifesciences Private Limited | 02-08-2020 | 20200802 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45825 | Not Recruiting | No | | | | 07-08-2020 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Puneet Mittal→ | | Clinical Operations Division,
121-B, Mansarovar Industrial Estate Extn
Panchli, Baghpat Road → | drabhijit@mgcts.org→ | 9822371703→ | Mittal Global Clinical Trial Services→ | Inclusion criteria: 1. Gender: Either male or non-pregnant, non-lactating female aged > 18-70 < years (both inclusive). <br/ ><br>2. Patients with RT-PCR confirmed diagnosis of COVID-19 <br/ ><br>3. Patients with mild to moderate COVID-19 infection having either one of the following criteria:PaO2/FiO2:200-300 OR Respiratory rate â?¥ 24/min and SaO2/SpO2 > 90% on room air <br/ ><br>4. Subjects willing to give written informed consent <br/ ><br>5. Subjects able to take the drug orally and comply with the study protocol <br/ ><br>6. Women of child bearing potential must have a negative urine pregnancy test prior to study entry→ | Exclusion criteria: 1. Patients with persistent vomiting <br/ ><br>2. Critically ill patients <br/ ><br>3.P/F ratio less than 200 (moderate-severe ARDS) <br/ ><br>4.Shock (Requiring Vasopressor to maintain a MAP more than 65 mm of hg or MAP below 65) <br/ ><br>5.Patients with known active hepatitis, tuberculosis and definite bacterial or fungal infections <br/ ><br>6.Patients with altered mental state <br/ ><br>7.Patients with multiple organ failure requiring ICU monitoring and treatment <br/ ><br>8.Patients with respiratory failure and requiring mechanical ventilation <br/ ><br>9.Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results. <br/ ><br>10.Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus. <br/ ><br>11.Patients who have received specific antiviral drugs ritonavir/lopinavir, or chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week before admission <br/ ><br>12.Patient who have participated in another investigational study within 3 months prior to enrollment in this study <br/ ><br>13.Investigators, study personnel, sponsorâ??s representatives and their first-degree relatives. <br/ ><br>14.Pregnant subjects <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 1. Immunofree 500 mg tablets<br>2. Reginmune 750 mg capsule: 2 tablets Immunofree 500 mg tablets thrice a day for 10 days and 1 capsule Reginmune 750 mg twice a day for 10 days<br>Control Intervention1: As per hospital protocol for Covid-19: As per standard National Clinical Management Protocol for COVID-19 by Government of India, Ministry of Health and Family Welfare, Directorate General of Health Services, (EMR Division), Version 3, 13.06.20<br>→ | Time (Days) to clinical improvement from study enrollmentTimepoint: Day 0, Day 5 and Day 10→ | | 01/12/2020 | | Yes | False | | |
| → | CTRI/2020/08/026980 | 27 January 2021 | Effect Ayurveda decoctions, tablet and Panchagavya on COVID 19 | Action Plan for COVID-19 based on Ayurveda decoctions, tablet and Panchagavya | | rashtriyakamdhenu ayog | 04-08-2020 | 20200804 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46082 | Not Recruiting | No | | | | 10-08-2020 | 180 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 3 | India→ | Parameswarappa Byadgi→ | | Associate Professor Head Department of Vikriti Vigyan Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi 221005 India
Department of Vikriti Vigyan, Faculty of Ayurveda, IMS, BHU→ | psbyadgi@gmail.com→ | 09450711759→ | Institute of Medical Sciences, BHU→ | Inclusion criteria: Subjects not enrolled in other clinical studies <br/ ><br>Patients who fulfils the Diagnostic features of COVID â?? 19 (Only symptomatic patients) <br/ ><br>Laboratory test positive for COVID â?? 19 <br/ ><br>Age of patients more than 10 years -90 years <br/ ><br>Both male and female patients. <br/ ><br>→ | Exclusion criteria: â?¢ Asymptomatic COVID â?? 19 patients will not be included <br/ ><br>â?¢ Seriously ill critical patients <br/ ><br>â?¢ Presenting serious symptoms <br/ ><br>â?¢ Suffering from complications <br/ ><br>â?¢ Age below 10 years <br/ ><br>â?¢ Vulnerable participants <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayurveda decoctions, tablet and Panchagavya: Gojihvadi Kwath with 30 ml twice a day on empty stomach <br><br> <br>Sanjeevani Vati â??<br>350 mg twice a day after meal with Fresh zinger juice and honey<br>PanchaGavya <br>Ghrit <br>Granules-10 g twice a daily with milk<br><br>Shunthi (Dry Ginger powder) 1 gm twice a day to put on the tongue till salivary secretion, after that it has to get swallowed. <br><br><br>Intervention2: Ayurveda decoctions, tablet and Panchagavya: Shirishadi Kwath<br>with 40 ml twice a day on empty stomach<br> <br>Sanjeevani Vati â??<br>350 mg twice a day after meal with Fresh zinger juice and honey<br>Pancha Gavya <br>Ghrit <br>Granules-10 g twice a daily with milk<br><br>Shunthi (Dry Ginger powder) 1 gm twice a day to put on the tongue till salivary secretion, after that it has to get swallowed. <br><br>Control Intervention1: Ayurveda decoctions, tablet and Panchagavya: parallel three arm<br>arm 1: Gojihvadi Kwath with 30 ml twice a day on empty stomach <br><br> <br>Sanjeevani Vati â??<br>350 mg twice a day after meal with Fresh zinger juice and honey<br>PanchaGavya <br>Ghrit <br>Granules-10 g twice a daily with milk<br><br>Shunthi (Dry Ginger powder) 1 gm twice a day to put on the tongue till salivary secretion, after that it has to get swallowed. <br><br>Arm 2: Shirishadi Kwath<br>with 40 ml twice a day on empty stomach<br> <br>Sanjeevani Vati â??<br>350 mg twice a day after meal with Fresh zinger juice and honey<br>Pancha Gavya <br>Ghrit <br>Granules-10 g twice a daily with milk<br><br>Shunthi (Dry Ginger powder) 1 gm twice a day to put on the tongue till salivary secretion, after that it has to get swallowed. <br><br>ARM 3: The general COVID 19 treatment protocols will be given<br>The general COVID 19 treatment protocols will be given<br>The general COVID 19 treatment protocols will be given<br>The general COVID 19 treatment protocols will be given<br><br>Control Intervention2:→ | Primary outcome: Patient becoming asymptomatic <br/ ><br>Secondary outcome: COVID 19 RT PCR becoming negative <br/ ><br>Timepoint: At 7 days and 15 days→ | | | | Yes | False | | |
| → | CTRI/2020/08/026964 | 27 January 2021 | An observational study of effect of positioning on either side on oxygen level in corona patient. | Impact of lateral positioning on oxygenation in Noninvasively ventilated Covid19 patient - A Prospective observational study. | | New Civil Hospital Surat | 04-08-2020 | 20200804 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46100 | Not Recruiting | No | | | | 09-08-2020 | 167 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sunaina patel→ | | Department of Anesthesilogy, Government medical college, Surat, opp. Income Tax Department Office, Majura Gate, Surat, Gujarat 395001 Same as address 1→ | patelsunaina79@gmail.com→ | 9825143013→ | Department of Anesthesioligy, Government medical college, surat→ | Inclusion criteria: a)Confirmed Covid19 patient with RT-PCR <br/ ><br>b)non invasively ventilated and hemodynamically stable. <br/ ><br>→ | Exclusion criteria: a)Patientâ??s refusal <br/ ><br>b)Patientâ?? with impending respiratory failure <br/ ><br>c)Immediate need for intubation(PaO2/FiO2 <50mm Hg, altered consciousness, unable to protect airway) <br/ ><br>d)Any condition which impedes giving lateral position.(like fracture). <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J984- Other disorders of lung
→ | | Changes in Oxygenation status( SpO2 from pulse oximetry and pO2 and other parameter from ABG)Timepoint: at Baseline(supine position) <br/ ><br>at 1 hour(after lateral position)→ | | | | Yes | False | | |
| → | CTRI/2020/08/026977 | 27 January 2021 | Comparison of two online learning method of resuscitation training. | A randomized control trial to compare the effectiveness of two online teaching methods for disseminating updated Cardio-pulmonary Resuscitation Guidelines in cardiac arrested COVID 19 patientsâ?? among nurses | | Poonam Joshi | 04-08-2020 | 20200804 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44057 | Not Recruiting | No | | | | 10-08-2020 | 20 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Poonam Joshi→ | | Room Number 5 Third Floor College of Nursing All India Institute of Medical Sciences, New Delhi-110029 → | pjoshi495@gmail.com→ | 9818039744→ | All India Institute of Medical Sciences→ | Inclusion criteria: undergone CPR training as per IRC guidelines <br/ ><br>willing to participate and <br/ ><br>Scores more than 80% in the screening test→ | Exclusion criteria: Not accessible (either left the institute or not traceable)→ | | Intervention1: Flexible online learning: training module will be uploaded on e-learning platform and participants will read them as per their convenience and at the end a zoom meeting will be organized to clear the doubts of the participants<br>Control Intervention1: Fixed slot training on CPR: Fixed slot training will be provided to the participants online at fixed time daily followed by chat<br>→ | To evaluate the impact of two different methods of online teaching for disseminating updated Cardio-pulmonary Resuscitation Guidelines in cardiac arrested COVID-19 patientsâ?? among nursesTimepoint: Baseline and at one week→ | | | | Yes | False | | |
| → | CTRI/2020/08/026962 | 27 January 2021 | Incubation period of COVID-19 cases admitted in North Kerala, India | Incubation period of COVID-19: Analysis of COVID-19 cases admitted in a Tertiary care centre, Northern District of Kerala, India | | Anitha S S | 04-08-2020 | 20200804 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46133 | Not Recruiting | No | | | | 01-09-2020 | 30 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Anitha S S→ | | Karakkad
Near Dhanalakshmi Nursing College
Kakkad
Kannur Community Medicine Department
Academic block fifth floor
Government Medical College Kannur
Kerala→ | dranithaprasanth@gmail.com→ | 9947107949→ | Government Medical College Kannur→ | Inclusion criteria: Confirmed cases of COVID-19 admitted in a tertiary care center→ | Exclusion criteria: Confirmed COVID 19 cases admitted in tertiary care center with no definite asymptomatic phase between exposure and symptom onset. <br/ ><br>Confirmed COVID-19 cases who were asymptomatic at the time of diagnosis.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | Incubation period of COVID-19Timepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/08/026985 | 27 January 2021 | Assessment of safety and efficacy of Kabasura
Kudineer in mild to moderate COVID-19 | Assessment of safety and efficacy of Kabasura
Kudineer as an add-on therapy in mild to moderate COVID-19. - Nil | | Chettinad Hospital and Research Institute | 04-08-2020 | 20200804 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46168 | Not Recruiting | No | | | | 14-08-2020 | 126 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Case Record Numbers Blinding and masking:Outcome Assessor Blinded | Phase 2 | India→ | Dr Ruckmani A→ | | Department of Pharmacology
Chettinad Hospital and Research Institute
Chettinad Health City
Kelambakkam
Chennai-603103 → | ruckmani.nirmal@gmail.com→ | 9500102346→ | Chettinad Hospital and Research Institute→ | Inclusion criteria: a.COVID-19 positive patients with mild to moderate disease. <br/ ><br>b.Males and females aged between 18 and 60 years who are admitted in Chettinad Hospital and Research Institute <br/ ><br>c.Patients willing to give written informed consent. <br/ ><br>→ | Exclusion criteria: a.Patients Suffering from Chronic diseases- hepatic, renal, Hypertension and Diabetes mellitus <br/ ><br>b.Pregnancy & lactation <br/ ><br>c. Severe COVID-19 <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Kabasura Kudineer along with standard treatment: Kabasura kudineer 60ml twice daily before food for 7 days along with standard treatment<br>Control Intervention1: Standard treatment as per the hospital protocol: Standard treatment as per the hospital protocol<br>→ | 1.Time to Negative conversion of SARS CoV-2 <br/ ><br>2.Time to symptom resolution <br/ ><br>3.Reduction in Viral load (0,4,7 days) <br/ ><br> <br/ ><br>Timepoint: 4,7 days→ | | | | Yes | False | | |
| → | CTRI/2020/08/026983 | 27 January 2021 | Point of care ultrasound study in patients with respiratory illness during COVID-19 | POCUS in patients with severe acute respiratory illness during the COVID-19 pandemic: A Prospective Observational Cross Sectional Study | | Kasturba Medical College and Hospital | 04-08-2020 | 20200804 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45679 | Not Recruiting | No | | | | 17-08-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sanjan→ | | Department of Emergency Medicine
Kasturba Medical College and Hospital
Manipal University Campus
Manipal, Udupi, Karnataka
INDIA → | sanjan.a@manipal.edu→ | 9447978877→ | Kasturba Medical College and Hospital Manipal University Campus Manipal→ | Inclusion criteria: Patients who were 18 years and older, severe acute respiratory illness. <br/ ><br>→ | Exclusion criteria: Patients less than 18 years or more than 80year, pregnant females and those not consenting to the study→ | Health Condition 1: J960- Acute respiratory failure
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: J168- Pneumonia due to other specified infectious organisms
Health Condition 4: J22- Unspecified acute lower respiratory infection
→ | | 1. To describe the various lung ultrasound (LUS) finding in patients with severe acute respiratory illness (SARI) <br/ ><br>2. To describe the various screening Echocardiographic changes in patients with severe acute respiratory illness (SARI)Timepoint: 1 year→ | | | | Yes | False | | |
| → | CTRI/2020/08/026978 | 27 January 2021 | Effectiveness of Ayurvedic Formulation for COVID 19 | Clinical evaluation of YASH-T decoction in the management of mild to moderate COVID-19 cases: Open label controlled trial | | Nepal Health Research COuncil | 04-08-2020 | 20200804 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44435 | | No | | | | 19-08-2020 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | Nepal→ | Shristi Karki→ | | Ministry of Health Complex
Ramshahpath Kathmandu Nepal → | shristi.karki1@gmail.com→ | 9808426339→ | Nepal Health Research Council→ | Inclusion criteria: Age between 18 to 70 years <br/ ><br>COVID-19 patients confirmed by RT-PCR testing within 4 days <br/ ><br>Symptomatic COVID-19 patients with Mild to Moderate <br/ ><br>Confirmed cases of COVID-19 in hospital with asymptomatic cases <br/ ><br>Participation of the subject is voluntary <br/ ><br>→ | Exclusion criteria: Children below 18 years <br/ ><br>Immunocompromised patients (HIV, Cancer, etc.) <br/ ><br>Co-morbid patients of HTN, COPD, Diabetes, Malignant tumour <br/ ><br>Pregnant women <br/ ><br>Severe or immediately life-threatening COVID-19 case <br/ ><br>Surgery undergone within past 6 months <br/ ><br>Patients of moderate to severe liver disease <br/ ><br>Patients of chronic kidney disease <br/ ><br>Drug Sensitivity <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayurvedic PolyHerbal Formulation: Polyherbal formulation will be given as the decocotion to the intervention group two times a day for 4 weeks in the intervention group<br>Other group will be control group with other local standard of care with no test drug<br>Control Intervention1: Local Standard of care: control group will proceed with other local standard of care with no test drug<br>→ | Duration of the positive to Negative Conversion of SARS-COV2Timepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/08/027007 | 27 January 2021 | An interventional study to access the effect of Ayurvedic medicine in positive cases of COVID-19. | A prospective open label randomised controlled trial of Ayurvedic intervention in asymptomatic and mild symptomatic cases of COVID-19 - SEM-20 | | Ministry of AYUSH | 05-08-2020 | 20200805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45827 | Not Recruiting | No | | | | 31-07-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | Dr Abhishek Bhattacharjee→ | | Room no-41
Department of Panchakarma
College of Ayurveda Mawdiangdiang
Shillong→ | drabhishekb@gmail.com→ | 8876059293→ | North Eastern Institute of ayurveda and homoeopathy→ | Inclusion criteria: 1. Individuals of either sex above the age of 15 years to 65 years. <br/ ><br>2. Subjects testing positive for SARS CoV-2 by RT-PCR, presenting with no symptoms or mild symptoms (as defined by US-CDC). <br/ ><br>3. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br>→ | Exclusion criteria: 1. Cases of COVID-19 with clinical severity ranging from moderate to critical (as defined by US-CDC). <br/ ><br>2. Pregnant and Lactating females. <br/ ><br>3. Subjects having uncontrolled and unstable co morbidities. <br/ ><br>4. Immunocompromised subjects or those taking any kind of immunosuppressive therapy. <br/ ><br>5. COVID-19 positive cases participating as subjects in other COVID-19 clinical trials. <br/ ><br>6. Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: SEM-20: Mahasudarshan Ghana vati - 500 mg <br> Samsamani vati - 1gm <br> Elankanadi Kwath -20 ml <br>One dose thrice after meal with 40ml water.<br>dose to be given for 10 days<br>Control Intervention1: Standard of Care: State Guidelines for the management of asymptomatic and mild cases of COVID-19 for 10 days<br>→ | 1) To assess the effectiveness of Ayurvedic fixed drug combination (Mahasudarshan ghana vati, Samsamani vati and Elakanadi kashaya) in preventing the progression of severity of the disease in SARS-CoV 2 tested positive asymptomatic and mild cases of COVID-19.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027008 | 27 January 2021 | Advantage of Artificial Intelligence to detect COVID 19 using Chest X-Ray. | Use of artificial intelligence(AI) in detection of COVID 19 case using CXR Data. | | Institute of Technology and Institute of Pharmacy NIRMA University | 05-08-2020 | 20200805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46099 | Not Recruiting | No | | | | 17-08-2020 | 1000 | Observational | Single Arm Trial<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Asutosh N Dave→ | | GCS Medical College and Hospital,
Department of radiodiagnosis.
Opp.D.R.M. Office, Naroda Rd,nr.Chamunda Bridge, Ahmedabad, Gujarat 380025
Phone: 079 6604 8000O. Department of radiodiagnosis.
Opp. D.R.M. Office, Naroda Rd, nr. Chamunda Bridge, Ahmedabad,→ | drasutosh@yahoo.com→ | 9825038648→ | GCS Medical College and Hospital→ | Inclusion criteria: Chest x-rays taken in department radiodiagnosis, GCSMC.→ | Exclusion criteria: NIL→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To compare the sensitivity of artificial intelligence in detection of COVID 19 using chest x rays to human radiologist.Timepoint: 2 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/026999 | 27 January 2021 | Evaluate the Efficacy of Siddha Treatment in Patients with Novel Coronavirus Infectious Disease (COVID-19) | A Prospective Randomized, Open-Label Study to Evaluate the Efficacy of Siddha Treatment in Patients with Novel Coronavirus Infectious Disease (COVID-19) in Coimbatore, Tamil Nadu - SIFRA-CBE | | Indian Medicine and Homeopathy Department Chennai | 05-08-2020 | 20200805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46134 | Not Recruiting | No | | | | 10-08-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Dr Shanmugam MD SIDDHA→ | | ESIC DEPARTMENT
Room No 5
Siddha Wing
7 5A ESI Dispensary kattoor 1
Dr Nanjappa Road
Near Hotel Tamilnadu
Kattoor 1 Coimbatore 18 → | salai.karthikaiyan@gmail.com→ | 9894750909→ | Indian Medicine and Homeopathy Department Tamilnadu→ | Inclusion criteria: 1. Admitted with COVID-19 infection determined by RT-PCR. <br/ ><br>2. Male , Non pregnant female above the age of 18 at the time of enrollment <br/ ><br>3. Subject provides informed consent form in written or in digital form <br/ ><br>4. COVID - 19 Positive with no clinical signs <br/ ><br>5. COVID - 19 Positive with mild symptoms â?? Sneezing, Cough, Sore Throat, Throat Pain, Malaise, Tiredness, Fever, loss of smell, loss of taste <br/ ><br>→ | Exclusion criteria: 1.Pregnancy and breast feeding females <br/ ><br>2.COVID - 19 Positive with Severe symptoms â?? Respiratory distress ( >24 breath per minute), Oxygen saturation < 95% at rest, Respiratory failure, Need of Mechanical Ventilation, Septic shock, Non respiratory organ failure <br/ ><br>3. Chronic Renal Failure requiring dialysis (eGFR < 30) <br/ ><br>4. Known cases of uncontrolled Diabetes ( >9% HbA1c) <br/ ><br>5. Known cases of stage 3 Hypertension ( > 160/100 mmHg) <br/ ><br>6. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>7. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>8. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>9.Subjects who are participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>10.Subjects with bleeding disorders and severe anemia (Hb <7) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Standard Drug Regimen followed by Tamil Nadu Government: 1.Tab.Ivermectin 12 mg STAT<br>2.Tab.Doxycycline 100 mg 1-0-1 for 5 days<br>3.Tab.Vitamin C- 500 mg 1 OD<br>4.Tab.Zinc 1 OD<br>5.Tab.paracetamol - 500 mg SOS<br>6. Cap.Omeprazole 20 mg SOS<br>7. Tab.Ondansetron 4 mg SOS<br>8.Tab.Montelukast 10 mg SOS<br>9.Tab.Bromhexine 16 mg SOS<br>Control Intervention1: Siddha Medicine: 1. Nochi Kudineer Chooranam â?? Decoction â?? Two times daily before 30 min of meals for 7 days <br>2. Mahasudarsan Chooranam â?? 5 gm â?? Two times daily after meals for 7 days with warm water/ Honey.<br>3.Maldevi Chendooram â?? 100 mg. Two Times daily, after meals for 7 days with honey.<br>4. Adathodai Manapagu â?? 10 ml- Morning And Evening for 7 days.<br>5. Omatheeneeer â?? 10 ml â??Twice daily with water after meals for 7 days.<br>→ | Primary Outcomes <br/ ><br>Reduction in Viral load of Novel-cov2 at the end of treatment(0, 7 days) <br/ ><br>Reduction of incidence of clinical symptoms/parameters like fever, cough / oxygen rate, respiration rate, temperature, <br/ ><br>Assessment of levels of inflammatory markers like LDH, D-dimer, CRP, ferritin at the end of treatment (0, 7 days)Timepoint: 7 th day→ | | 08/11/2020 | | Yes | False | | |
| → | CTRI/2020/08/027005 | 27 January 2021 | Investigation of effect of homoeopathic remedy as add on therapy to standard of care (regular treatment) in adult patients with moderate to severe COVID-19 | A Phase 2 evaluation of the efficacy of homoeopathic remedy Zincum Muriaticum as an adjuvant therapy to standard of care in adult patients with moderate to severe COVID-19: Randomized, double-blind, parallel group, placebo controlled, multicenter trial (ZIMCOV) | | Homoeocon Foundation | 05-08-2020 | 20200805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46189 | Recruiting | No | | | | 12-08-2020 | 96 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | Dr Anil Khurana→ | | 61-65 Institutional Area, Opp D Block, Janak Puri, New Delhi → | ccrhindia@gmail.com→ | 011-28525523→ | Central Council for Research in Homoeopathy→ | Inclusion criteria: A subject will be considered eligible for inclusion in this study only if ALL of the following criteria apply: <br/ ><br>1. Hospitalized patient with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) (or any other confirmatory test to diagnose SARS-CoV-2 infection if there is such change in guidelines issued time to time by the Government of India, Task Force for COVID or any other concerned authority/body assigned for this purpose) as documented by either of the following: <br/ ><br>PCR positive in sample collected < 72 hours prior to randomization; OR <br/ ><br>PCR positive in sample collected â?¥ 72 hours prior to randomization with documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) <br/ ><br>2. Subject (or legally acceptable representative) understands and agrees to comply with planned study procedures and provides informed consent prior to initiation of study procedures. <br/ ><br>3. Male or non-pregnant female adult â?¥18 years of age at time of enrolment. <br/ ><br>4. Illness with â?¤12 days duration, and at least one of the following: <br/ ><br>Radiographic infiltrates by imaging captured during the period between date of admission to date of enrolment that is chest x-ray, CT scan, lung ultrasound. <br/ ><br>Presence of clinical features of dyspnea and or hypoxia, fever cough including Respiratory rate > 24 breaths/min OR SpO2 < or equal to 94 on room air <br/ ><br>Requiring supplemental oxygen <br/ ><br>Requiring HFNO/NIV <br/ ><br>5. Women of childbearing potential must agree either to abstinence or to use at least one primary form of contraception not including hormonal contraception from the time of screening till end of the study. <br/ ><br>6. Subject (or legally acceptable representative) agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 till end of this study. <br/ ><br>7. Subject (or legally acceptable representative) is willing to be a study participant and to accept randomization to any assigned treatment arm. <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Physician makes a decision that trial involvement is not in patientâ??s best interest, or there is any condition that does not allow the protocol to be followed safely. <br/ ><br>2. There is anticipated discharge from the hospital or transfer to another hospital which is not a study site within 72 hours. <br/ ><br>3. Patient already in another clinical trial of an experimental treatment for COVID-19 <br/ ><br>4. Patient has a PaO2/FiO2 ratio < 200 or is requiring IMV/ECMO at baseline.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Zincum muriaticum 200C: Sucrose globules premedicated with liquid potency will be administered per orally. A single dose will consist of two globules of size 40. The dosage will be six times a day at an interval of 3 hours between two successive doses<br>In case patents are intubated, they will receive reconstituted dilution PO<br>Dosing frequency will be02 drops two hourly eight times a day.<br>Upon discharge, the dosage will be three times a day at an interval of 6 hours between two successive doses<br><br>Control Intervention1: Identical Plaebo: Sucrose globules premedicated with liquid potency will be administered per orally. A single dose will consist of two globules of size 40. The dosage will be six times a day at an interval of 3 hours between two successive doses<br>In case patents are intubated, they will receive reconstituted dilution PO<br>Dosing frequency will be02 drops two hourly eight times a day.<br>Upon discharge, the dosage will be three times a day at an interval of 6 hours between two successive doses<br><br>→ | TTR (Time to Recovery)Timepoint: Censored at Day 28 <br/ ><br>TTR is defined as the time (in days) from randomization of study treatment (active or placebo) until Day of recovery. Day of recovery is defined as the first day on which the subject satisfies one of the following three categories from the eight category ordinal scale→ | | | | Yes | False | | |
| → | CTRI/2020/08/027000 | 27 January 2021 | Retrospective cohort study in COVID 19 recovered patients | Association Between Prophylactic Ayush Interventions And Disease Outcome In Covid 19 Positive Patients: A Retrospective Cohort Study - RCS-AYUSH | | Central Council for Research in Homoeopathy | 05-08-2020 | 20200805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45722 | Recruiting | No | | | | 14-08-2020 | 5000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Anil Khurana→ | | Central Council for Research in Homoeopathy
61-65 iNSTITUTIONAL aREA, oPPOSITE d Block Janakpuri
Delhi → | drdnayak@gmail.com→ | 9873404012→ | Central Council for Research in Homoeopathy→ | Inclusion criteria: 1.Recovered COVID-19 positive patients, tested virologically positive (RT-PCR) since the declaration of pandemic in India <br/ ><br>2.Willingness to participate in the study <br/ ><br>→ | Exclusion criteria: 1.Refusal to participate by patient, parent or guardian.→ | | | 1.Information about clinical course of disease etc. <br/ ><br>Timepoint: One time. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/08/026998 | 27 January 2021 | Youth experiences during COVID-19 pandemic | Experiences of youth during the COVID-19 pandemic â?? The MINDS study | | Dr Varalakshmi Chandra Sekaran | 05-08-2020 | 20200805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46243 | Not Recruiting | No | | | | 14-08-2020 | 540 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Varalakshmi Chandra Sekaran→ | | Department of Community Medicine
Melaka Manipal Medical College (Manipal campus)
MAHE, Manipal → | varalakshmi.cs@manipal.edu→ | 9535810325→ | Melaka Manipal Medical College (Manipal campus), MAHE, Manipal→ | Inclusion criteria: Inclusion criteria : Youth both male and female between the ages of 18-24 years who consent to participate in the study→ | Exclusion criteria: None→ | | | Experiences of the youth during the lockdown and challenges experienced during the COVID-19 outbreak in relation to social relationships with family members and peers, perceptions regarding mental health needs as well as the coping methods employed will be studied.Timepoint: August 10th, 2020 to January 31, 2021→ | | | | Yes | False | | |
| → | CTRI/2020/08/027009 | 27 January 2021 | Use of Herbal Medicine like Tulasi,Amruth(Giloy), Turmeric,Ashwagandha for Improving the Immunity among Health care workers. | A Clinical Study to Evaluate the role of Herbal Immunomodulators(sriveda sattva Pvt Ltd)in Boosting the Immunity among Health Care Workers assigned to COVID-19 Wards. | | Sriveda Sattva Private Limited Sri Sri Tattva | 05-08-2020 | 20200805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46269 | Not Recruiting | No | | | | 15-08-2020 | 100 | Interventional | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Dr M Ravi Kumar Reddy→ | | Sriveda Sattva Pvt Ltd 54/56 39th A Cross 11th Main Road 4th
TBlock Jayanagar Bangalore Karnataka India 560041
Bangalore
KARNATAKA → | bmccrj@gmail.com→ | 9448292424→ | | Inclusion criteria: 1.Participants willing to give written informed consent.(Annexure 1) <br/ ><br>2.Participants of either sex aged between 18 and 60 years. <br/ ><br>3.Health care workers -Nurses <br/ ><br>→ | Exclusion criteria: Participants who are not willing to give consent for the study. <br/ ><br>2. Participants with comorbidities like Hypertension, Type 1 or 2 Diabetes mellitus, <br/ ><br>3. Participants suffering from chronic conditions affecting any of the major organs such as, Liver, Kidney, heart and Lungs <br/ ><br>4. Pregnant women/lactating mothers <br/ ><br>5. Participants on immunosuppressants <br/ ><br>→ | | Intervention1: Immunity Kit: a)Shakthi drops: 5 drops 3 times a day<br>b)Amruth tablet: 1 tablet 2 times a day<br>c)Turmeric Plus tablet:1 tablet 2 times a day<br>d)TulsiArka: 10 drops 3 times a day<br><br>Control Intervention1: will not receive anything: will not receive anything. will be control arm.<br>→ | 1.Measurement of serum levels of Anti-oxidant biomarkers such as Superoxide dismutase (SOD), Catalase, Malondialdehyde (MDA), Glutathione (GSH) at baseline (Day 0) and Day 15 <br/ ><br>2. Measurement of serum levels of Immune biomarkers such as IFN-β and <br/ ><br>IFN- λ at baseline (Day 0) and Day 15 <br/ ><br>Timepoint: Day 0 and Day 15→ | | | | Yes | False | | |
| → | CTRI/2020/08/027001 | 27 January 2021 | association of cardiac markers with severity of covid 19 | Correlation between myocardial enzyme serum levels and markers of inflammation with severity of COVID 19:A prospective observational study. | | Nil | 05-08-2020 | 20200805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45531 | Not Recruiting | No | | | | 20-08-2020 | 70 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sunder Lal Negi→ | | deptt anaesthesia and intensive care PGIMER, chandigarh PGIMER, Chandigarh→ | dr.sundernegi@gmail.com→ | 7087009506→ | deptt of anaesthesia→ | Inclusion criteria: all Male and female patient will be taken for study.→ | Exclusion criteria: known case of myocardial infarction→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: cardiac biomarkers: cardiac biomarkers will be considered in all patients admitted to covid center<br>Control Intervention2: Nil: Nil<br>→ | correlation between covid 19 severity andTimepoint: 24 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/08/027033 | 27 January 2021 | SARS-COV-2 and COVID-19 - A Randomized controlled trail (unblinded) | Effectivenss of an Siddha treatment approach in SARS-COV-2 and COVID-19 - A Randomized controlled trail (Unblinded) at Govt. Kipauk Medical College, Chennai-10 | | Government siddha medical college | 07-08-2020 | 20200807 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46096 | Not Recruiting | No | | | | 07-08-2020 | 100 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2 | India→ | Dr A Shiyam ranjith→ | | Department of General medicine
Government Siddha Medical College
Arumbakkam
Chennai 106 → | nanbu.sumi@gmail.com→ | 9443279412→ | Government Siddha Medical College→ | Inclusion criteria: Rt-PCR positive patients, Asymptomatic patients, Fever, Dry cough, Sore throat, Difficulty in breathing→ | Exclusion criteria: Bronchogeniccarcinoma, Pulmonary TB, Pregnancy and lactating mothers, Status asthmatics→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nilavembu kudineer<br>Kabasura kudineer<br>Thippili rasayanam<br>Aadathodai manapagu<br>Swasakudori maathirai<br>Thoothuvalai legiyam<br>Amukara chooranam<br>Seenilnthil chooranam<br>Pavala parpam<br>Silasathu parpam<br>Sivanar amirtham<br>Muthu parpam<br>Gargle- with Turmeric,Thripala,Alum,Glycyrrhiza glabra,Salt: <br>Nilavembu kudineer-60ml bd oral administration for 14 days<br>kabasura kudineer-60ml bd oral administration for 14 days<br>thippili rasayanam- 5gm bd oral administration for 14 days<br>aadathodai manapagu- 5ml BD hotwater oral administration for 14 days<br>swasakudori maathirai-2 bd hot water oral administration for 14 days<br>thoothuvalai legiyam- 5gm bd with milk oral administration for 14 days<br>amukara chooranam-2gm bd oral administration for 14 days<br>seenthil chooranam -2gm bd oral administration for 14 days<br>pavala parpam-100mg bd oral administration for 14 days<br>silasathu parpam- 100mg oral administration bd for 14 days<br>sivanar amirtham-60g bd oral administration for 14 days<br>muthu parpam-100mg bd oral administration for 14 days<br>Gargle- with Turmeric,Thripala,Alum,Glycyrrhiza glabra,Salt<br>Control Intervention1: tab azithromycin <br>Tab Hydroxychloroquinine<br>tab paracitamol<br>tab vitamin c<br>tab zinc<br>tab multivitamin<br>inj enoxaparin<br>inj methylperenidasolone <br>kabasura kudineer: tab azithromycin 500mg bd oral administration<br>Tab Hydroxychloroquinine 200mg oral administration <br>tab paracitamol650mg bd oral administration<br>inj methylperenidasolone intravenous <br>inj enoxaparin intravenous<br>tab vitamin c oral administration<br>tab zinc oral administration<br>tab multivitamin oral administration<br>kabasura kudineer 60ml oral administration<br>→ | Outcomes is mainly assessed by reduction in Clinical symptoms and Rt-PCR test NegativeTimepoint: 3 Months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027032 | 27 January 2021 | A clinical study to assess the effects of MEDITATION (MINDFUL HAPPINESS) as an additional therapy in asymptomatic and mildly symptomatic covid-19 confirmed cases | A clinical study to evaluate the role of MEDITATION (MINDFUL HAPPINESS) as an adjunct therapy in asymptomatic and mildly symptomatic covid-19 confirmed cases | | Sonalika Social development Society | 07-08-2020 | 20200807 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45920 | Not Recruiting | No | | | | 11-08-2020 | 40 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Meena Dalal→ | | TrialGuna, 467, 3rd Floor, 1st Main, 4th Cross Rd, Royal County Layout, 2nd Block, 8th Phase, Bengaluru, Karnataka 560083 467, 3rd Floor, 1st Main, 4th Cross Rd, Royal County Layout, 2nd Block, 8th Phase, Bengaluru, Karnataka 560083→ | bhagee_252@yahoo.com→ | 971555855964→ | Wow Power Yoga→ | Inclusion criteria: 1. Male female subjects of age group between 18 â?? 60 years <br/ ><br>2. Subjects who are COVID-19 confirmed cases, with mild severity presenting with signs and symptoms qualifying for low clinical risk (NEWS scoring 0-4) <br/ ><br>3. Subjects with SARS-CoV-2 RT-PCR confirmed COVID-19 positive with 72 hours from symptom onset or patient within 48 hours after laboratory diagnosis (SARS-CoV-2 RT-PCR) <br/ ><br>4. Subjects who are literate in English <br/ ><br>5. Female of childbearing potential willing to follow reliable and strict contraceptive measures <br/ ><br>6. Subjects judged to be reliable for compliance for performing meditation and capable of recording the effects of the meditation and motivated in receiving benefits from the meditation and compliance to quarantine procedure (as per prevailing guidelines) <br/ ><br>7. Willingness to provide written inform consent to participate in the study <br/ ><br>→ | Exclusion criteria: 1. Confirmed COVID-19 positive cases with NEWS scoring system â?¥ 5 <br/ ><br>2. Individual with acute respiratory distress presenting with RR >24/minute, SaO2/SPO2â?¤94 % in room air condition, or the PaO2/FiO2 ratio <300mgHg <br/ ><br>3. Those who are regular practitioners of pranayama or meditation, defined as practicing any method of pranayama or meditation or both for at least 50 % of days in the last 1-month period <br/ ><br>4. Pregnant and breast-feeding females <br/ ><br>5. Recent history of significant lung disease like Asthma or Chronic Obstructive Lung Disease (COPD). <br/ ><br>6. Those who have pre-existing severe mental illnesses such as Bipolar disorder or schizophrenia <br/ ><br>7. Severe sleep problems defined as less than 3 hours of sleep every day for the preceding 7 days <br/ ><br>8. Suffering from Immunocompromising conditions or taking any immunosuppressing therapy <br/ ><br>9. Subjects suffering from severe and uncontrolled metabolic, endocrinal, cardiac/ renal/liver disease. <br/ ><br>10. The subject who are unable or unwilling to comply fully with the study protocol. <br/ ><br>11. Physician makes a decision that trial involvement is not in patientâ??s best interest, or any condition that does not allow the protocol to be followed safely. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Meditation (Mindful Happiness): Arm A subjects will be advocated to perform meditation (Mindful Happiness) as an adjunct therapy along with standard of care<br>Control Intervention1: Standard care of therapy: Arm B will only receive standard care of therapy<br>The standard care will be as per the local hospital protocol and as per recommendations/guidelines by the respective authorities (Ministry of Health and Family Welfare, CDC and USFDA) whichever fits best at the time of initiation of this study. This will also be followed by the best supportive care guidelines recommended by the authorities (Ministry of Health and Family Welfare, CDC and USFDA).<br>→ | 1) Time to Clinical Recovery (duration): 4 weeks <br/ ><br>2) Change in PSS scale from baseline between 2 arms <br/ ><br>3) Changes in Serum Cortisol Levels from baseline <br/ ><br>4) Changes in WHO 5 QOL scale from baseline between 2 arms <br/ ><br>Timepoint: 1) Time to Clinical Recovery (duration): 4 weeks <br/ ><br>2) Change in PSS and Changes in WHO 5 QOL scale from baseline between 2 arms will be evaluated on day 1, day of discharge, day 7 from date of discharge, day 14 from date of discharge. <br/ ><br>3) Change in serum cortisol levels from baseline will be evaluated on day 1, date of discharge and 14 days after date of discharge <br/ ><br> <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/08/027034 | 27 January 2021 | An observational study of Guduchi Extract Tablet | Evaluation of Efficacy and Safety of Guduchi (Tinospora cordifolia) Extract Tablet in Healthy Population during COVID-19 Pandemic-An open label single arm Non randomized Observational Study. | | Central council for Research in Ayurvedic Sciences Ministry of AYUSH Govt of India New Delhi | 07-08-2020 | 20200807 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46193 | Not Recruiting | No | | | | 15-08-2020 | 1200 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sanjay Srivastava→ | | Department of Shalya Tantra, University College of Ayurveda, Room Number 162, Dr. S.R. Rajasthan Ayurved University, Jodhpur, Nagaur Road, Kadwad, Jodhpur
Jodhpur
RAJASTHAN
342037
India → | vc.dsrrau@gmail.com→ | 8800543828→ | Dr. S.R. Rajasthan Ayurved University, Jodhpur→ | Inclusion criteria: 1. Healthy individuals (male &female) subject between the age group of 18-70 years who are living in Jodhpur city. <br/ ><br>2. Those who do not have any acute medical condition or chronic medical/surgical condition that requires either immediate or continuous medical monitoring or treatment will be treated as Healthy individuals. <br/ ><br>3. Participants who can take medicines orally. <br/ ><br>→ | Exclusion criteria: 1. Cases of severe vomiting which would affect oral administration of medicine difficult. <br/ ><br>2. Positive COVID-19 patient (asymptomatic/symptomatic/mild) <br/ ><br>3. Cases of respiratory failure and requiring mechanical ventilation. <br/ ><br>4. Combined organ failure requiring ICU monitoring. <br/ ><br>5. Patients with uncontrolled Diabetes Mellitus, (HbA1c more than 8.0), Malignant Hypertension (systolic BP more than 180 and diastolic 110), Chronic Renal Failure and those on immunosuppressive medication. <br/ ><br>6. Pregnant and Lactating females <br/ ><br>7. Any other condition, which as per the investigator would jeopardize the outcome of the trial. <br/ ><br>→ | | Intervention1: Nil: Nil<br>→ | 1. Prevention of incidence of COVID-19 in subjects taking Guduchi Extract Tablet. <br/ ><br>2. Prevention of incidence of non-specific symptoms such as fever, fatigue, cough anorexia, malaise, muscle pain, sore throat, dyspnea, nasal congestion, or headache. <br/ ><br> <br/ ><br>Timepoint: 15 days→ | | | | Yes | False | | |
| → | CTRI/2020/08/027038 | 27 January 2021 | Study to assess effects of nano ozonised hydrogen peroxide nebulisation on results of RT-PCR for novel corona Virus thus infectivity and clinical course among mild to moderate sick COVID-19 Patients | A Prospective ,randomized ,double blind,placebo controlled study to access effects of nano ozonized hydrogen peroxide nebulization on results of RTPCR for noval corona virus thus infectivity and clinical course among mild to moderate sick Covid 19 patients HOPE in Covid 19(Hydrogen Peroxide Inhalation). | | SN medical College | 07-08-2020 | 20200807 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46197 | Not Recruiting | No | | | | 20-08-2020 | 100 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | DrAshish Gautam→ | | Department of Medicine SN Medical College Raja Mandi near Central library Agra-282003 → | ppagrawal120@gmail.com→ | 9319250485→ | S N Medical College→ | Inclusion criteria: All newly diagnosed patients <br/ ><br>Not requiring mechanical ventilation <br/ ><br>on oxygen therapy <br/ ><br>Tolerating hydrogen peroxide nebuliser <br/ ><br>Consenting patients <br/ ><br>On same treatment protocol→ | Exclusion criteria: Patients not giving consent <br/ ><br>Patient not tolerating nebulization→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Triozone: 1 ml of trio zone mixed with 4 ml of normal saline given 3 times a day from nasal route . a cumulative 5ml single dose is used for nebulisation by nasal route once a day .<br>Control Intervention1: Placebo: 5ml of 0.9 % normal saline will be used as placebo given by nasal route . thrice a day at same doses of trial drug. Normal saline do not have any effects over virus replication and free of any side effects.<br>→ | Proportion of patients who turned negative on RT-PCR for for nCOV for two consecutive days.Timepoint: 6 month→ | | | | Yes | False | | |
| → | CTRI/2020/08/027035 | 27 January 2021 | A randomized trial to evaluate effect of mediatation on Stress and Anxiety due to COVID-19 in healthy adult population | A pilot randomized control trial to reduce stress and improve psychological resilience due to COVID-19 outbreak in healthy adult population through Rajyoga meditation delivered via digital media | | Dr Divya Jain | 07-08-2020 | 20200807 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46262 | Not Recruiting | No | | | | 19-08-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | N/A | India→ | Dr Divya Jain→ | | Department of Ophthalmology
Superspeciality Pediatric hospital and postgraduate teaching institute, Sec 30 ,Noida → | divyajain27@hotmail.com→ | 9810656627→ | Superspeciality pediatric hospital and postgraduate teaching institute,Noida→ | Inclusion criteria: Healthy population <br/ ><br> <br/ ><br>1.Participants who complete the online assessment forms and give consent to participate <br/ ><br> <br/ ><br>2. Age group more than 18 years of age <br/ ><br> <br/ ><br>3. Exposed to news about the Covid crisis and access to media/ conversations amounting to at least 1 hour in 1 week <br/ ><br> <br/ ><br>4. Self-reported anxiety/distress due to COVID <br/ ><br> <br/ ><br>5. Ability to understand written and spoken English to give self-report <br/ ><br> <br/ ><br>6. General physical fitment <br/ ><br> <br/ ><br>7. Access to internet and competence to use the same <br/ ><br>8. Willing to follow study protocol and timeline <br/ ><br>→ | Exclusion criteria: 1.Subjects with history of or current neurological or psychiatric impairment, or cognitive dysfunction that could compromise data collection. <br/ ><br>2. Subjects with severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled diabetes mellitus, myocardial infarction or heart failure within 30 days of recruitment) as per investigatorâ??s <br/ ><br>assessment. <br/ ><br>3. Those already practicing meditation or any other relaxation practice <br/ ><br>4. Negligible or mild anxiety due to COVID-19 determined on basis of anxiety score <br/ ><br>5. Those who have been diagnosed with COVID and their family members→ | | Intervention1: Rajyoga meditation: Rajyoga mediation with the help of audio-visual aids provided by Dr Banarsi Lal Secretary medical wing of Rajyoga Meditation Education and Research Foundation, a sister concern of Brahmakumaris spiritual university. Visual aids from Brahma Kumari Sister Shivani will also be used for relieving anxiety and psychological stress. We will make an attempt to prepare <br>a Rajyoga Meditation App if convenience and time permits. This kind of Rajyoga meditation app module will allow patient to understand the basic concept of mediation and its application relevant to improve <br>immunity against COVID-19. If app not feasible then the applied part will include practice of selfempowering affirmations and creative visualization as per protocol developed by Medical wing of <br>Brahmakumaris. In this case the mediation module will be delivered to every patient via WhatsApp (through audio and visual commentaries) and will be daily assisted and monitored by designated mediation <br>teachers to ensure patientâ??s understanding and compliance. <br>The participants will have to practice meditation and self-relaxation for 20 minutes each day as suitable according to their daily routine for 1 month. After fortnight the compliance in the study will be monitored <br>by a google form with questionnaire on regularity in using app and following meditation protocol, and any improvement in pre intervention studied parameters will be assessed. A final post intervention assessment will be done at the end of 30 days and change in anxiety score due to mediation intervention <br>will be seen.<br>Control Intervention1: counselling: They will be provided general relaxation techniques and counseling.The participants will have to practice self-relaxation for 20 minutes each day as suitable accord→ | 1.Relief of stress assessed by perceived stress scale <br/ ><br>2. Decrease in anxiety as measured by Anxiety ScaleTimepoint: 1 month, the parameters studied will be assessed at 15 days and 1 month post intervention→ | | | | Yes | False | | |
| → | CTRI/2020/08/027036 | 27 January 2021 | Retrospective Analysis of 245 COVID-19 Cases from a Government Teaching Hospital of North India | Epidemiological and clinical characterization of COVID-19 patients:A Retrospective observational study of 245 cases in a Government Teaching Institute of North India | | Dr Divya Jain | 07-08-2020 | 20200807 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46280 | Not Recruiting | No | | | | 19-08-2020 | 245 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Divya Jain→ | | Department of Ophthalmology
Superspeciality Pediatric Hospital and Postgraduate Teaching Institute, Sec 30,Noida → | divyajain27@hotmail.com→ | 9810656627→ | Superspeciality Pediatric hospital and Postgraduate Teaching Institute,Noida→ | Inclusion criteria: First 245 confirmed COVID-19 positive patients by RTPCR admitted to COVID-19 Facility SSPH&PGTI, Noida. <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1.Suspected COVID-19 patients <br/ ><br> <br/ ><br>2.Patients with Negative RT-PCR <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Epidemiological and clinical profiling of laboratory confirmed cases of COVID-19 patients admitted in our centre.The various <br/ ><br>categories under this head would be: <br/ ><br>a)Age wise distribution: neonatal, infants, toddlers, preschool, school-going and adolescents, adults <br/ ><br>b)Male and female <br/ ><br>c) Source of infection i.e. travel history, contact history, cluster cases and undefined. <br/ ><br>d) d) Case profiling of patients into subtypes depending on severity of infection-mild, moderate and severe. <br/ ><br> <br/ ><br>Timepoint: basline, on discharge→ | | | | Yes | False | | |
| → | CTRI/2020/08/027037 | 27 January 2021 | Effect of Yoga for COVID-19 patients in addition to regular treatment | Assessment of Yoga as an adjuvant therapy to standard care in COVID-19 patients - COVID-19 | | Sri Devaraj Urs Academy of Higher Education and Research Kolar Karnataka | 07-08-2020 | 20200807 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46324 | Recruiting | No | | | | 17-08-2020 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Outcome Assessor Blinded | Phase 3 | India→ | Nitin Patil→ | | Dept. of Integrative Medicine
Sri Devaraj Urs Academy of Higher Education and Research Kolar → | ayushnitin@gmail.com→ | 9886211008→ | Sri Devaraj Urs Academy of Higher Education and Research Kolar→ | Inclusion criteria: 1.Patients who has tested positive for SARS CoV2 done through RT- PCR (reverse transcriptase polymerase chain reaction) <br/ ><br> <br/ ><br>2.Patients with mild to moderate disease symptoms <br/ ><br>→ | Exclusion criteria: 1 Patients on treatment for mental illness <br/ ><br>2.Any other severe illness <br/ ><br>3.Pregnancy and lactating women <br/ ><br>4. Practiced Yoga in last 3 months <br/ ><br> <br/ ><br>→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Standard care and Yoga Intervention: Standard care <br><br>and Yoga as follows <br><br>Loosening Exercises<br>Pranayama<br>Yoga Nidra<br><br>Duration: 35 Minutes<br>Frequency: Five days a week for four weeks<br><br><br>Control Intervention1: Standard care: Standard care for COVID-19 as per Ministry of Health and Family welfare, Government of India<br>→ | Depression, Anxiety and Stress Scale (DASS-21) <br/ ><br>Pittsburgh Sleep Quality Index (PSQI) <br/ ><br>Perceived Stress Scale (PSS) <br/ ><br>WHO Quality of life â?? BREF (WHOBREF) <br/ ><br> <br/ ><br>Timepoint: 1st Day <br/ ><br>30th Day→ | | | | Yes | False | | |
| → | CTRI/2020/08/027040 | 27 January 2021 | An interventional study to access the effect of Ayurvedic medicine in positive cases of COVID-19. | Assessment of efficacy and safety of Ayurvedic drug combination
in preventing the progression of severity of the disease in asymptomatic and mild symptomatic cases of COVID-19: A randomised controlled trial
| | Ministry of AYUSH | 08-08-2020 | 20200808 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45846 | Not Recruiting | No | | | | 12-08-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | Dr Bishnu Choudhury→ | | Department of Kayachikitsa
College of Ayurveda Mawdiangdiang→ | drbishnuchoudhury@gmail.com→ | 9401597062→ | North Eastern Institute of ayurveda and homoeopathy→ | Inclusion criteria: 1. Individuals of either sex above the age of 15 years to 65 years. <br/ ><br>2. Subjects testing positive for SARS CoV-2 by RT-PCR, presenting with no symptoms or mild symptoms (as defined by US-CDC). <br/ ><br>3. Subjects who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study→ | Exclusion criteria: 1. Cases of COVID-19 with clinical severity ranging from moderate to critical (as defined by US-CDC). <br/ ><br>2. Pregnant and Lactating females. <br/ ><br>3. Subjects having uncontrolled and unstable co morbidities. <br/ ><br>4. Immunocompromised subjects or those taking any kind of immunosuppressive therapy. <br/ ><br>5. COVID-19 positive cases participating as subjects in other COVID-19 clinical trials. <br/ ><br>6. Subjects having a past history of allergy to any medicine that is part of the Ayurvedic intervention. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: MSL: Mahasudarshan Ghana vati - 500 mg thrice daily after meal<br> Samsamani vati - 500gm thrice daily after meal<br> Lavangadi vati - 500mg thrice daily after meal to be chewed.<br>the dose to be given for 10 days<br>Control Intervention1: Standard of Care : State Guidelines for the management of asymptomatic and mild cases of COVID-19 for 10 days<br>→ | 1) To assess the effectiveness of Ayurvedic fixed drug combination (Mahasudarshan ghana vati, Samsamani vati and Lavangadi vati) in preventing the progression of severity of the disease in SARS-CoV 2 tested positive asymptomatic and mild cases of COVID-19.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027047 | 27 January 2021 | Nursing students perception of out of the classroom learning during the period of COVID-19 | Nursing Studentsâ?? perceptions towards Pandemic Pedagogy â?? a cross sectional survey | | Mrs Prima Jenevive Jyothi DSouza | 09-08-2020 | 20200809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46338 | Not Recruiting | No | | | | 31-08-2020 | 380 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Linu Sara George→ | | Department of Fundamentals of Nursing, Manipal College of Nursing,
Manipal Academy of Higher Education, Manipal → | prima.jj@manipal.edu→ | 9986244210→ | Manipal College of Nursing→ | Inclusion criteria: Undergraduate students→ | Exclusion criteria: Not willing to participate in the study <br/ ><br>Not responding to the online survey→ | | | Perception of pandemic pedagogyTimepoint: only one time contact with the participants. Assessing the outcome only ones.→ | | | | Yes | False | | |
| → | CTRI/2020/08/027048 | 27 January 2021 | Yoga for Police personnel | Assessment of Pranayama and Yoga Nidra on mental health and quality of life among Police personnel during COVID-19 pandemic - COVID-19 | | Sri Devaraj Urs Academy of Higher Education and Research Kolar Karnataka | 09-08-2020 | 20200809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46344 | Recruiting | No | | | | 17-08-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Outcome Assessor Blinded | Phase 3 | India→ | Dr Patil NJ→ | | Dept. of Integrative Medicine, Sri Devaraj Urs Academy of Higher Education and Research (Deemed to be University) Kolar → | ayushnitin@gmail.com→ | 9886211008→ | Sri Devaraj Urs Academy of Higher Education and Research Kolar→ | Inclusion criteria: 1.Police personnel having at least one month of COVID-19 pandemic related duty. <br/ ><br>2.Age 21 to 50 years <br/ ><br>3.Perceived stress scale score 14 and above. <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1.Practiced Yoga in last 3 months <br/ ><br>2.Underwent recent surgery <br/ ><br> <br/ ><br>→ | | Intervention1: Pranayama and Yoga Nidra in addition to Routine activities: Pranayama <br> Kaphalbhati kriya <br> (Preparatory) <br> Nadishuddhi <br> Bhramari pranayama, <br> Nadanusandhana<br>Yoga Nidra<br><br>Duration: 40 minutes<br>Frequency: 5 days a week for 6 weeks<br>Control Intervention1: Routine activities: Routine activities<br>→ | Depression, Anxiety, Stress scale-21 (DASS-21) <br/ ><br>Fear of COVID-19 Scale <br/ ><br>Perceived Stress Scale (PSS) <br/ ><br>Pittsburgh Sleep Quality Index (PSQI) <br/ ><br>Timepoint: 1st Day / Baseline <br/ ><br>6th Week→ | | | | Yes | False | | |
| → | CTRI/2020/08/027049 | 27 January 2021 | Study of families who travelled from another place and had COVID-19 | Retrospective analysis of asymptomatic familial clusters with history of travel and diagnosed with COVID-19 | | Dr TMA Pai Hospital Melaka Manipal Medical College Manipal Academy of Higher Education | 09-08-2020 | 20200809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46361 | Not Recruiting | No | | | | 20-08-2020 | 19 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shashikiran Umakanth→ | | Department of Medicine, Dr TMA Pai Hospital, Melaka Manipal Medical College, Manipal Academy of Higher Education → | shashikiranu@gmail.com→ | | Manipal Academy of Higher Education→ | Inclusion criteria: i. Either gender admitted in Dr TMA Pai Hospital, Udupi, Karnataka between 01 May 2020 and 01 June 2020 <br/ ><br>ii. Diagnosed with COVID-19 <br/ ><br>iii. Asymptomatic at presentation <br/ ><br>iv. History of inter-state travel within one month of admission→ | Exclusion criteria: Those files with missing demographic details required for the study will be excluded.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Transmission to family membersTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/08/027051 | 27 January 2021 | Survey of challenges faced by pain and palliative physicians working in cancer set up during corona virus disease time | A questionnaire based survey on challenges faced and strategies adopted by Pain and Palliative care physicians working in oncology setup during novel COVID 19 Pandemic-
A descriptive cross sectional study
| | AIIMS New Delhi | 09-08-2020 | 20200809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44061 | Not Recruiting | No | | | | 10-08-2020 | 200 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Seema Mishra→ | | Room No. 249, Second Floor, IRCH, AIIMS → | seemamishra2003@gmail.com→ | | Dr, BRAIRCH, AIIMS, New Delhi→ | Inclusion criteria: Health care professionals practising pain and palliative care in oncology setup. <br/ ><br>Willing to participate in the study <br/ ><br>Able to understand English <br/ ><br>→ | Exclusion criteria: Not willing to participate in the study→ | | | To assess the challenges faced by the pain and palliative care physicians working in oncology setup in delivering their services and the strategies they have adapted to mitigate these challenges during the time of novel COVID 19 pandemicTimepoint: At the time of filling questionnaire→ | | | | Yes | False | | |
| → | CTRI/2020/08/027050 | 27 January 2021 | Assessment of PPE usage pattern and the associated Surgeon Discomfort and Fatigue Study. | Survey to assess the pattern of Personnel Protective Equipmentâ??s (PPE) use among Surgical Oncologists during routine cancer surgery in COVID-19 negative patients and the associated discomforts and/or fatigue attributable to its use. - PPE Study | | None | 09-08-2020 | 20200809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46415 | Not Recruiting | No | | | | 20-08-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrShivakumar Thiagarajan→ | | 1209 Homi Bhabha Block Tata Memorial Hospital Parel Mumbai. 1209 Homi Bhabha Block Tata Memorial Hospital Parel Mumbai.→ | drshiva78in@gmail.com→ | 09846572399→ | Tata Memorial Centre→ | Inclusion criteria: Surgical Oncologists operating with PPE on COVID negative cancer patients in the pandemic→ | Exclusion criteria: Non-surgical oncologist→ | | | Primary: Assess the various PPE used <br/ ><br>Secondary: Discomfort and fatigue attributed to PPE use.Timepoint: Since the start of the lockdown to till date→ | | 08/09/2020 | | Yes | False | | |
| → | CTRI/2020/08/027045 | 27 January 2021 | A clinical study to evaluate efficacy and safety of Camphora tablets in Covid positive patients | A randomized, double blind, prospective, placebo-controlled, comparative study to evaluate the efficacy and safety of Camphora tablets when given as add-on therapy to Standard of Care in hospitalized patients who are SARS-CoV-2 positive - Camphora in COVID | | Dr Ashish Agarwal | 09-08-2020 | 20200809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46226 | Not Recruiting | No | | | | 17-08-2020 | 300 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | Dr Renuka Munshi→ | | G Building, 5th Floor, Department of Clinical Pharmacology, TN Medical College and BYL Nair Hospital, Mumbai Central → | renuka.munshi@gmail.com→ | 02223027204→ | TN Medical College and BYL Nair Hospital→ | Inclusion criteria: 1.Patients who are able to provide a written informed consent or have a legally accepted representative to provide the same. <br/ ><br>2.Patients who are proven to be positive for SARS-CoV-2 infection, as confirmed by the RT-PCR test 48 hours prior to the entry into the study. <br/ ><br>3.Patients who are admitted with mild / moderate/ severe COVID-19 (as per MOFHW criteria) for treatment at the hospital <br/ ><br>4.Female patients with a negative urine pregnancy test at screening. <br/ ><br>5.Patients who are able to take the study drug orally and comply with the study procedures→ | Exclusion criteria: 1.Patients who are participating in any other clinical trial or experimental treatment for COVID-19. <br/ ><br>2.Patients requiring concomitant use of invasive mechanical ventilation. <br/ ><br>3.Patients requiring vasopressors or ionotropic medications. <br/ ><br>4.Patients requiring anti-viral drugs like ritonavir, lopinavir, remdesivir or monoclonal antibodies like tocilizumab at hospitalization <br/ ><br>5.Female Patients who are pregnant or lactating. <br/ ><br>6.Patients who are known to be HIV positive or positive for Hepatitis B or C. <br/ ><br>7.Patients with liver enzymes (namely alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)) > 5x upper limit of normal. <br/ ><br>8.Patients who are not deemed fit as per the investigator for any other medical reason→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Camphora tablets: Mild infection: Camphora (1M) 4 pills every 4 hours until symptoms abate.<br>Moderate infection: Camphora (10M) 4 pills every 3 hours until symptoms abate.<br>Severe infection: Camphora (10M) 4 pills every 2 hours until symptoms abate <br>To be taken for 10-14 days or till discharge<br>Control Intervention1: Placebo: Mild infection: Placebo 4 pills every 4 hours until symptoms abate.<br>Moderate infection: Placebo 4 pills every 3 hours until symptoms abate.<br>Severe infection: Placebo 4 pills every 2 hours until symptoms abate <br>To be taken for 10-14 days or till discharge<br>→ | This will include determination of the proportion of subjects showing clinical improvement in both the treatment groupsTimepoint: Day 0, Day 7, Day 14 or Discharge→ | | | | Yes | False | | |
| → | CTRI/2020/08/027043 | 27 January 2021 | Mesenchymal Stem Cell Therapy For Covid 19 | A Phase 1 clinical trial of intravenous administration of mesenchymal stem cells derived from umbilical cord and placenta in patients with novel COVID-19 virus pneumonia. | | Neurogen Brain and Spine Institute | 09-08-2020 | 20200809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43175 | Not Recruiting | No | | | | 10-08-2020 | 20 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 1 | India→ | Dr Abhijit Bopardikar→ | | ReeLabs Pvt. Ltd.
1st Floor, KK Chambers, Sir P.T. Road, Fort, Mumbai → | drrohitrkulkarni@gmail.com→ | 9820526618→ | ReeLabs Pvt. Ltd.→ | Inclusion criteria: Patients admitted with RT-PCR confirmed COVID-19 illness. <br/ ><br>Age: 18-65 years without any uncontrolled comorbidities like hypertension, diabetes, renal failure, etc <br/ ><br>Written informed consent <br/ ><br>Has any of the two <br/ ><br>PaO2/ FiO2: 200-300 <br/ ><br>Respiratory Rate > 24/min and SaO2 â?¤ 93% on room air→ | Exclusion criteria: Pregnant women <br/ ><br>Breastfeeding women <br/ ><br>Critically ill patients: <br/ ><br> P/F ratio < 200 (ARDS ) <br/ ><br> Shock (Requiring Vasopressor to maintain a MAP â?¥ 65mmHg or MAP below 65) <br/ ><br>Patients with other severe co-morbidities like cancer, chronic renal, chronic liver failure and chronic cardiac failure. This will not include diabetes, hypertension, etc <br/ ><br>Participating in any other clinical trial→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Mesenchymal Stem Cells: Mesenchymal Stem cells derived from umbilical cord and placenta<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | 1. Avoidance of - <br/ ><br>Progression to severe ARDS (P/F ratio 100) and All-cause Mortality at 28 days <br/ ><br>2. Oxygenation Index : SpO2 <br/ ><br>3. Multi Organ Function: CBC,LFT,Serum Creatinine,Electrolytes, <br/ ><br>4. Troponin and Myoglobin <br/ ><br>5. Clinical measures: Fever and Respiratory Rate <br/ ><br>6.Immediate Adverse Events occurring after IV administration of MSCs <br/ ><br>7. Other adverse events e.g. Pulmonary embolism, Stroke, Arrhythmias, Liver failureTimepoint: All Days→ | | | | Yes | False | | |
| → | CTRI/2020/08/027046 | 27 January 2021 | A survey to analyze the understanding about the use of face mask among the general public during COVID 19 | Questionnaire on use of mask: knowledge and attitude amongst individuals during COIVD 19 | | None | 09-08-2020 | 20200809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46254 | Not Recruiting | No | | | | 20-08-2020 | 697 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Vaishali K→ | | Department of Physiotherapy,
Manipal College of Health Professions, Manipal Academy of Higher Education, Madhav nagar, Manipal → | vaishali.kh@manipal.edu→ | 8296011839→ | Manipal Academy of Higher Education→ | Inclusion criteria: Those able to ambulate independently <br/ ><br>Those able to read and understand English <br/ ><br>Non febrile <br/ ><br>no neurological or musculoskeletal conditions→ | Exclusion criteria: → | | | Online Questionnaire- google formTimepoint: 10 minutes→ | | 31/08/2020 | | Yes | False | | |
| → | CTRI/2020/08/027041 | 27 January 2021 | Clinical trial on COVID 19 patients to Improve Immunity | â??A Prospective, Open label, Randomized-controlled study to evaluate the efficacy and safety of Herbovir Syrup in mildly symptomatic COVID- 19 patientsâ?? | | Venkat Pharma | 09-08-2020 | 20200809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46258 | Not Recruiting | No | | | | 14-08-2020 | 40 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | Sri H Srinivas→ | | Venkat Pharma
130/122 &15/6, Hallimala, Sri Rama Hills Road,
Ramanagara, Karnataka-562159 → | sreenivas.drugs@gmail.com→ | 9448080317→ | Venkat Pharma→ | Inclusion criteria: 1.Subjects aged 18-65 years of age and of either sex <br/ ><br>2.Subjects who are willing to give consent to the study <br/ ><br>3.COVID-19 positive clinical symptoms and (subsequently) confirmedby the current recommended confirmatory test. <br/ ><br>4.Mild to moderate clinical disease <br/ ><br>5.Can take oral medicines <br/ ><br>6.Subject willing to abide by and comply with the study protocol <br/ ><br>→ | Exclusion criteria: 1.Age less than 18 years and more than 65 years <br/ ><br>2.Pregnancy and lactation <br/ ><br>3.Severe or complicated course of COVID-19 disease <br/ ><br>4.Presence of acute hypoxic respiratory failure/ need for Intensive care unit (ICU) stay/Patients who need mechanical ventilation. <br/ ><br>5.Subjects taking steroid treatment and or any kind ofimmunosuppressive therapy <br/ ><br>6.Any uncontrolled systemic disease, infection <br/ ><br>7.Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease or any other disorder. <br/ ><br>8.Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: HERBOVIR SYRUP <br>(Ayush approved formulation): Dose: 10 ml thrice daily <br>Dosage form: Syrup<br>Route: Orally<br>Time of Administration: Morning,After noon and night after meal <br>Total duration: 14 days<br>Control Intervention1: NIL: NIL<br>→ | Improvement in LDH, TLC, CRP, D-DIMER and RT PCR from baseline to end of the studyTimepoint: Day 0 and End of the study (Day 7 to 14)→ | | | | Yes | False | | |
| → | CTRI/2020/08/027042 | 27 January 2021 | Secondary attack rate of COVID 19, Kerala | Secondary attack rate of COVID 19: Analysis of contacts of COVID 19 cases admitted in a Tertiary care center, Northern district of Kerala, India, A Cross- sectional Study | | Anitha S S | 09-08-2020 | 20200809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46277 | Not Recruiting | No | | | | 01-09-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Anitha S S→ | | Community Medicine Department
Academic block fifth floor
Government Medical College
Kannur Kerala Community Medicine Department
Academic block fifth floor
Government Medical College
Kannur Kerala→ | dranithaprasanth@gmail.com→ | 9947107949→ | Government Medical College Kannur→ | Inclusion criteria: Primary contacts of COVID 19 cases admitted in tertiary care center→ | Exclusion criteria: In situations where contact tracing cannot be completed, such COVID 19 cases will not be included for calculating Secondary attack rate.→ | | Control Intervention1: NIL: Not Applicable<br>→ | Secondary attack rate of COVID 19Timepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/08/027044 | 27 January 2021 | To observe the outcome of Classical Ayurvedic medicine for the treatment of COVID-19 | Proposal for Ayurvedic Management Protocol and Add-on to the Standard care for Covid-19 | | Shri Krishna Ayush University | 09-08-2020 | 20200809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44249 | Not Recruiting | No | | | | 14-08-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Professor Dr Anil Sharma→ | | Shri Krishna AYUSH University
Sector-8, Umri Road,
Kurukshetra, Haryana → | drashishhmehta@gmail.com→ | 91-8950375285→ | Shri Krishna AYUSH University→ | Inclusion criteria: 1. RT_PCR based laboratory confirmation test for COVID-19 <br/ ><br>2.Typical clinical presentation of acute onset febrile illness with sore throat and dry cough with or without shortness of breath in a patient from a known â??hot spotâ?? area or in close contact with a confirmed COVID-19 case with a negative laboratory test for COVID 19 and H1N1 influenza. <br/ ><br>3. Patients with either sex, 18 to 60 years age. <br/ ><br>4. Patients who can take oral medicine. <br/ ><br>5. Uncomplicated illness and Mild Pneumonia Cases <br/ ><br>6. Patients with mild-moderately severe disease <br/ ><br>7. All patients must agree not to share medication <br/ ><br>8. Patients willing to participate and sign an informed consent Understands and agrees to comply with planned study procedures. <br/ ><br>9.Agrees to the give OP swabs and venous blood for testing as per Protocol. <br/ ><br>→ | Exclusion criteria: 1. Patients suffering from severe COVID-19 Disease as judged by a physician and fulfilling at least two of the following three criteria <br/ ><br>(i) Respiratory distress at room ambience (equal or more than 30 breaths per min) <br/ ><br>(ii) Oxygen saturation at rest equal or less than 93% (peripheral digital arterial oxymetry) and requiring oxygen support for over one hour to normalize <br/ ><br>(iii) Any of the known COVID-19 complications and emergency procedures which may require shift/admission in intensive care unit such as respiratory failure, adult respiratory distress syndrome, requirement of oxygen support for over 1 hour, requirement of mechanical ventilation, septic shock, or severe non-respiratory organ dysfunction or failure. <br/ ><br>2. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study <br/ ><br>3. History of immunosuppression: solid organ or bone marrow transplant, use of immunosuppressive antimetabolic and biologic agents, intrinsic immunodeficiencies, HIV infection. <br/ ><br>4. Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. <br/ ><br>5. Patients on parenteral nutrition <br/ ><br>6. Patients with known sensitivity or contraindication to any of the ingredients of study medication <br/ ><br>7. History of bleeding haemorrhoids, haemoptysis, acid peptic diseases, ulcers and pulmonary diseases (tuberculosis, asthma, etc.) <br/ ><br>8. Patients who are likely to worsen or planed ICU admission or ventilator support due to any reason. <br/ ><br>9. Pregnancy and lactation <br/ ><br>10. Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19 <br/ ><br>11. Participation in any other clinical trial of an experimental agent treatment for COVID-19 <br/ ><br>12. Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind. <br/ ><br>13. Physician decision that involvement in the study is not in the patient´s best interest. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Maha-Sudarshana Ghan Vati: Dose: One Tablet (500 mg each) thrice daily<br>Dosage form: Tablets <br>Route of Administration: Oral <br>Time of Administration: Thrice a day<br>After food Anupana: Shadanga Paniya in place of water whole day <br>Duration of therapy: 30 days<br><br>Control Intervention1: Conventional standard therapy for COVID-19 positive patients: Conventional standard therapy as per ICMR/WHO parameters<br>→ | a) Mean time (days) for clinical recovery [Day of randomization to the day of clinical recovery b) Proportion of patients showing â??clinical recoveryâ??.Timepoint: Baseline and on 30th day→ | | | | Yes | False | | |
| → | CTRI/2020/08/027082 | 27 January 2021 | To assess the fear and readiness of medical workers to work in the health care set up in the state of Karnataka during COVID-19 illness after the lock down is over. | Assessment of fear and the level of preparedness of medical care staff in the state of Karnataka towards the lifting of the lock down and reestablishing of a fully functional health care system in the realms of the Covid-19 pandemic | | Prabhleen Kaur Sibal | 10-08-2020 | 20200810 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46351 | Not Recruiting | No | | | | 18-08-2020 | 600 | Observational | Other<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Dr Sadhana N Holla→ | | Department of Pharmacology
KMC Manipal, Manipal University → | sadhana.holla@manipal.edu→ | 8746828049→ | Kasturba Medical College→ | Inclusion criteria: 1. Doctors (allopathic) <br/ ><br>2. Doctors (AYUSH) <br/ ><br>3. Dentists <br/ ><br>4. Interns/students <br/ ><br>5. Nurses <br/ ><br>6. Laboratory technicians <br/ ><br>7. Pharmacist <br/ ><br>8. Paramedical staff <br/ ><br>Participants with age more than 18 years, meeting the required inclusion criteria, able to understand English and willing to give informed consent will be included. The data will be collected over a span of 2 months. <br/ ><br>→ | Exclusion criteria: Medical care workers not giving informed consent will be excluded from the study <br/ ><br> <br/ ><br>→ | | Intervention1: Nil: Nil<br>→ | To determine the medical care facility preparedness in provision of services after the lifting of the lock down. <br/ ><br>To assess the fear and concern of medical care workers in delivering health services after the phasing off of the lock down. <br/ ><br>To identify the relationship between socio-demographic, psychological and Covid-19 related variables in medical care workers <br/ ><br>Timepoint: Time point: Once <br/ ><br>Online cross-sectional study targeting medical care workers across the state of Karnataka in both private and government institutions. <br/ ><br> <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/08/027078 | 27 January 2021 | Establishment of surveillance system for individuals diagnosed with COVID-19. | Establishment of surveillance system for individuals diagnosed with SARS-CoV-2. | | Tata Memorial Hospital | 10-08-2020 | 20200810 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45924 | Not Recruiting | No | | | | 17-08-2020 | 1200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Rajesh Dikshit→ | | Centre For Cancer Epidemiology, Advanced Centre for Treatment Research and Education in Cancer, Utsav Chowk - CISF Rd, Kharghar, Navi Mumbai, Maharashtra 410210
Mumbai
MAHARASHTRA
410210
India → | dixr24@hotmail.com→ | 9969518844→ | Centre For Cancer Epidemiology→ | Inclusion criteria: Suspected or confirmed novel Coronavirus (nCoV) infection case as the main reason for admission to the study centre <br/ ><br>Age group: above 18 <br/ ><br>→ | Exclusion criteria: Refusal by the participant or appropriate representative.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Establishing a data base with a number of individuals with mild, moderate and severe symptoms.Timepoint: o months, 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027079 | 27 January 2021 | study of lab investigations among hospitalized COVID-19 patients | Biomarkers in prognostic assessment of hospitalized COVID-19 patients | | Dr Swathy Moorthy | 10-08-2020 | 20200810 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46185 | Not Recruiting | No | | | | 17-08-2020 | 1000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Swathy Moorthy→ | | Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai, TamilNadu → | drswathymoorthy@sriramachandra.edu.in→ | 9444016401→ | Sri Ramachandra University→ | Inclusion criteria: all hospitalized COVID-19 patients→ | Exclusion criteria: all hospitalized non COVID-19 patients→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | positive correlation between biomarkers and prognosis, severity of COVID-19 hospitalized patientsTimepoint: at baseline→ | | | | Yes | False | | |
| +++ | CTRI/2020/08/027077 | 27 January 2021 | Study of Efficacy and Safety of DV890 in Patients With COVID-19 Pneumonia | Phase 2, randomized, controlled, open label multi-center study to assess efficacy and safety of DFV890 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function | | Novartis Healthcare Pvt Ltd | 10-08-2020 | 20200810 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45442 | Recruiting | No | | | | 01-11-2020 | 120 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2 | | | | | | | | | | | | | | | | Yes | False | | |
| → | CTRI/2020/08/027084 | 27 January 2021 | Evaluate the medicinal effects of both Ayurveda combinations Bio-Immune as Anti-viral and Covalix Vaccoil as alternate to Vaccine of COVID-19 on exposed individuals and Covid19 contact. | Study on Clinical Effects, Prolonged Safety and Efficacy of both Ayurveda combinations Bio-Immune as Anti-viral and Covalix Vaccoil as alternate to Vaccine of COVID-19 on exposed individuals and SARS2 nCoV contact - BICV19P | | Leaf BioLab Leaf Research Institute A Unit of Young Naturalist Network | 10-08-2020 | 20200810 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44420 | Not Recruiting | No | | | | 20-08-2020 | 61000 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | N/A | India→ | AMIT DUTTA→ | | Delhi Office:
Leaf BioLab, Leaf Research Institute
(A Unit of Young Naturalist Network):2nd Floor, B-277-A, Block-B, Nangal Dewat, Vasant Kunj Enclave, New Delhi-110070, India. International Office:
Leaf BioLab, Leaf Research Institute
(A Unit of Young→ | leafbiolab@gmail.com→ | 9874077009→ | Leaf BioLab, Leaf Research Institute (A Unit of Young Naturalist Network)→ | Inclusion criteria: 1. Subjects must be divided into two major groups: <br/ ><br>A) Controlled Group <br/ ><br>B) Uncontrolled Group <br/ ><br> <br/ ><br>Control Group: <br/ ><br>Healthy Individuals <br/ ><br>Proven cases of SARS2 nCoV with or without other health issues like COPD, DM, HTN etc <br/ ><br> <br/ ><br>Uncontrolled Group: <br/ ><br>Asymptomatic patients who are not SARS2 nCoV positive, which can be either those who tested negative or normal public.→ | Exclusion criteria: 1. Patients who are taking radiation therapy <br/ ><br>2. Patients with sepsis, HIV, Autoimmune <br/ ><br>3. Patients on ventilator (critical SARS2 nCoV patients, who used any drug in treatment process) <br/ ><br>4. Patients below age of 5 years <br/ ><br>5. Patients with nerve disorder <br/ ><br>6. History of receipt of blood transfusion or immunoglobulin products or expected receipt through the duration of the study <br/ ><br>7. Known hepatic dysfunction including known or suspected active or chronic hepatitis infection <br/ ><br>8. Clinically significant congenital anomaly of the respiratory tract <br/ ><br>9. Inability to take oral medication <br/ ><br>10.Prolonged QTc-interval in baseline ECG ( >500 ms) <br/ ><br>11. Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis <br/ ><br>12. Need of anticoagulants, antiplatelet agents, antithrombotics and thrombolytics during the treatment period. <br/ ><br>13. Participation in another research study involving an investigational agent within 30 days prior to consent <br/ ><br>14. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results <br/ ><br>15. Patients not willing to give written informed consent <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Bio-Immune as Anti-viral for SARS2 nCoV: 2 grams Bio-Immune powder three times daily in lukewarm water after food by oral route for 30 days.<br>Intervention2: Covalix Vaccoil as alternate to Vaccine of SARS2 nCoV: 5-10 ml of Covalix Vaccoil liquid in every alternate days by oral route in the form of 7-10 dosages. Covalix Vaccoil works as alternate to Vaccine of SARS2 nCoV.<br><br>Control Intervention1: Water and fruit juice: Water and fruit juice<br>→ | 1. Clinical cure rate: Time to get a negative status from SARS2 nCoV (defined as viral load of respiratory and serological specimen negative for two consecutive times when tested in an interval of two days)Timepoint: 30 days→ | | | | Yes | False | | |
| → | CTRI/2020/08/027061 | 27 January 2021 | Investigator Initiated Study to see the safety and efficacy of adding Thymosin Alpha to existing standard of care in severe COVID patients. | A Prospective, Single-Center, Investigator Initiated Clinical Study to Evaluate the
Effectiveness and Safety of Thymosin α-1 (Tα1) in severe COVID-19 patients | | Dr Rahul Pandit | 10-08-2020 | 20200810 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45729 | Not Recruiting | No | | | | 13-08-2020 | 15 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Adarsh Shetty→ | | Gufic Biosciences Limited
Subhash Road A Block
Vile Parle East Mumbai → | medicalaffairs@guficbio.com→ | 912267261000→ | Gufic Biosciences Limited→ | Inclusion criteria: 1.Male females of greater than or equal to 18 years of age at the time of consent <br/ ><br>2.Patient who can and willing to provide written Informed Consent <br/ ><br>3.Severe Acute Respiratory Syndrome Coronavirus SARS CoV 2 infection confirmed by polymerase chain reaction PCR test any other confirmatory tests <br/ ><br>4.If the patient presents any one of the following features <br/ ><br>respiratory distress with a respiratory rate greater than equal toâ??30 breath per min <br/ ><br>SpO2 oxygen saturation less than or equal toâ??90 percentage on room air <br/ ><br>PaO2 arterial blood oxygen partial pressure FiO2 Fraction of Inspired Oxygen less than or equal toâ??200 mmHg 1 mmHgâ??0.133 kPa <br/ ><br>Patient presents respiratory failure and requires mechanical ventilation support <br/ ><br>5.Patient patients LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements. <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1 Patient who has participated in any other clinical trial of an experimental treatment for COVID-19 <br/ ><br>2 Patient with presence of any pre-existing illness that, in the opinion of the investigator, would place the patient at an unreasonably increased risk through participation in this study. <br/ ><br>3 Patient who has participated in another trial with an investigational drug within 1 month prior to this trial. <br/ ><br>4 Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Immunocin α 1.6 mg: Two subcutaneous injections of 1.6 mg Tα1 TID per day for at least seven consecutive days.<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | 1. Incidences of all-cause hospital mortality <br/ ><br> <br/ ><br>2.Duration of patients admitted in ICU and use of Ventilator. <br/ ><br> <br/ ><br>3.Duration of hospitalizationTimepoint: 1. Incidences of all-cause hospital mortality <br/ ><br> <br/ ><br>2.Day 1 to Day 7 <br/ ><br> <br/ ><br>3.From baseline to hospital discharge→ | | 01/11/2020 | | Yes | False | | |
| → | CTRI/2020/08/027080 | 27 January 2021 | Benefit of positioning in COVID-19 patient on Bipap mechnical support | Effect of awake positioning on outcome of covid-19 patients on Bipap ventilator - Bipap | | Dept of Anaesthesia GCS Medical college Hospital and Research Center | 10-08-2020 | 20200810 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46272 | Not Recruiting | No | | | | 15-08-2020 | 100 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | Phase 3/ Phase 4 | India→ | Dr Carolin Smita Kerketta→ | | Room no 87 dept of Anaesthesia
GCS medical college & hospital campus Naroda Road
opp DRM office
Ahmedabad Dept of Anaesthesia
GCS medical college & hospital campus Naroda Road
opp DRM office
Ahmedabad→ | carolinsmita@gmail.com→ | 9904451321→ | GCS medical college & hospital→ | Inclusion criteria: COVID-19 positive / suspected patients <br/ ><br>ARDS confirmed based on Berlin criteria 2012 <br/ ><br>Acute onset of respiratory symptoms < 1 week <br/ ><br>B/L Chest X-Ray opacities not explained by effusion, cardiac failure, lobar collapse. <br/ ><br>PaO2/FiO2 ratio > 200 mm Hg <br/ ><br>Age: 30 â?? 80 years <br/ ><br>BMI < 30 kg/m2 <br/ ><br>Fio2 requirement > 50 % on room air <br/ ><br> <br/ ><br> <br/ ><br>→ | Exclusion criteria: COVID-19 negative patients <br/ ><br>Drowsy patient <br/ ><br>Un co-operative <br/ ><br>Glassgow Coma Scale < 6 <br/ ><br>PaO2/FiO2 <100 mmHg <br/ ><br>BMI > 30 kg/m2 <br/ ><br>Age <30 yrs > 80 years <br/ ><br>Cervical spondylosis <br/ ><br>Glaucoma <br/ ><br>Pregnancy <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | On Bipap Ventilator whether prone position is better than supine?Timepoint: 5 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027081 | 27 January 2021 | Comparision of two barrier devices for placement of tube into trachea(windpipe)in COVID19 patients | Clear Plastic drape vs Acrylic box during Airway management implication for COVID 19 - Airway Management | | Department of AnaesthesiaGCS Medical CollegeHospital Research CentreAhmedabad | 10-08-2020 | 20200810 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46289 | Not Recruiting | No | | | | 17-08-2020 | 500 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | Dr Heena Chhanwal→ | | Department of Anaesthesia,Room no.87,GCS medical college hopital and research centre, opp. DRM office, naroada road, Ahmedabad 380025 GCS medical college hopital and research centre, opp. DRM office, naroada road, Ahmedabad 380025→ | drmrshc@gmail.com→ | 9925497393→ | GCS medical college→ | Inclusion criteria: COVID positive/suspected patient <br/ ><br>No improvement in Respiratory Distress <br/ ><br>Tachypnea (RR >30/min) <br/ ><br>Poor oxygenation (PaO2 :FiO2 ratio <150mmhg after 2 hour high flow O2 therapy on non invasive mode ventilation <br/ ><br>Altered sensorium / shock/convulsion <br/ ><br> on ABG PaO2 <60 & PaCO2 >60 <br/ ><br>Age >15 and <90 yrs <br/ ><br>Informed consent <br/ ><br>→ | Exclusion criteria: <br/ ><br>COVID negative patient <br/ ><br>Patient with Nil mouth opening <br/ ><br>Age <15 and >90 years of age <br/ ><br>Patient with airway pathology(oral, pharyngeal, laryngeal carcinoma <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Barrier devices: Comparison of clear plastic drape versus Acrylic box for Airway management in COVID 19 patients<br>→ | Our purpose of this study to know which barrier device is better for airway manipulation in COVID 19 patientsTimepoint: 8 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027083 | 27 January 2021 | Giloy Gomutra Capsule, Asthi churna aur Kamdhenu Asava ka vaishvik mahamari Covid-19 par logo ka anubhav aur Chikitsakiya prabhava ka Ankalan | Real world experience about efficacy and safety of Giloy Gomutra (Cow Urine), Asthi Churna and Kamdhenu Asava in the management of COVID-19 in Indian setting. (REAL Giloy Gomutra, Asthi Churna and Kamdhenu Asava Product) | | Bansi Gir Gaushala | 10-08-2020 | 20200810 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46331 | Not Recruiting | No | | | | 18-08-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label | N/A | India→ | Dr Dineshchandra H Pandya→ | | B-19, First Floor, District Shopping Centre, Sector-21, Gandhinagar, Gujarat → | urvipandya18@gmail.com→ | 9638300839→ | Neuropanch Ayurveda Hospital and Research Organization→ | Inclusion criteria: Treating physician had to agree to provide information regarding the Patients who have been diagnosed with Covid-19 with mild and moderate symptoms.→ | Exclusion criteria: Patient having severe symptoms will not be included in the study <br/ ><br>Any condition that according to the discretion of the investigator indicate that the patient is not suitable for inclusion in the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 1)Giloy Gaumutra Capsules 2)Asthi Churna 3)Kamdhenu Aasava  : All the three drugs were given to all patients , it will be single experimental group. This Ayurvedic treatment given for 15 days.Giloy Gaumutra Capsules 4 tds with water. Asthi Churna 5 gm with Hot water for two times, Kamdhenu Asava 15 ml for two times with hot water For 15 days by Oral route.<br>→ | Covid-19 Negative Test ConfirmationTimepoint: Covid-19 Negative Test Confirmation after recovery around 1 or 2 weeks.→ | | 16/09/2020 | | Yes | False | | |
| → | CTRI/2020/08/027085 | 27 January 2021 | Safety and efficacy of citrobioShield product in improving immunity in COVID 19 patients via inhalation. | A single centric, prospective, open label, interventional study to evaluate the efficacy and safety of CitriobioShield as an adjunct with standard of care therapy in improving immunity in mild to moderate COVID 19 patients through inhalation of fog. | | GERMKILL INDIA | 11-08-2020 | 20200811 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46278 | Not Recruiting | No | | | | 17-08-2020 | 20 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Open Label | N/A | India→ | Subham Dutta→ | | 2nd Main Road, Building #06, 3rd Floor.
Arekere, Sarvobhogam Nagar.
Bangalore → | germkillindia@gmail.com→ | 9449242921→ | GERMKILL INDIA→ | Inclusion criteria: 1. Male or non-pregnant female between 18 to 65 years of age at the time of enrolment. <br/ ><br>2. Subject or LAR providing written informed consent and agrees to follow study procedure. <br/ ><br>3. Woman with child bearing potential confirming use of primary contraception <br/ ><br>4. Mild to moderate freshly confirmed COVID 19 positive subjects in less than 24 hours not requiring emergency or ICU care at the time of enrolment <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Severe COVID 19 patients requiring ventilation or oxygen support when diagnosed. <br/ ><br>2. Females who are planning to conceive during the study duration or are pregnant already or are breastfeeding. <br/ ><br>3. Subjects having serious or unstable respiratory disorders (self-reported) <br/ ><br>4. Subject already on immune therapy (self-reported) <br/ ><br>5. Immunodeficiency or organ transplant (self-reported) <br/ ><br>6. Autoimmune disease (self-reported) <br/ ><br>7. Current acute infection or exacerbation of a chronic illness (self-reported) <br/ ><br>8. Cancer within last 5 years (self-reported) <br/ ><br>9. Known infection with HIV, Hepatitis B & Hepatitis C (self-reported) <br/ ><br>10. Drug abuse/alcohol abuse (self-reported) <br/ ><br>11. Plasma donation within last 4 months (self-reported) <br/ ><br>12. Receiving blood or immunoglobulins within 3 months (self-reported) <br/ ><br>13. SGOT/SGPT greater than 5 times normal value (self-reported) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: CitrobioSheild: organic citrus extract (Bioflavonoid Complex). <br>Dosage regimen: Inhalation by fogging for 3 mins per day for 7 days with 10% solution and a rate of 50 ml/min.<br>Control Intervention1: Standard of care treatment: Standard of care treatment as per the government approved guidelines for COVID- 19<br>→ | 1. The time taken to relieve the individual symptoms in both the groups. <br/ ><br>(fever, dry cough, tiredness, aches and pains, sore throat, diarrhoea, headache, loss of taste or smell, difficulty breathing or shortness of breath, chest pain or pressure) after 7 days. <br/ ><br> <br/ ><br>2. Change in everyday clinical status of the subjects on a 7-point ordinal scale during the course of 7 days <br/ ><br>Timepoint: 7 days→ | | 10/09/2020 | | Yes | False | | |
| → | CTRI/2020/08/027094 | 27 January 2021 | Role of Digital communication in COVID 19 isolation facilities an observation study | Assessment of role of internet based audio-visual communication in COVID 19 isolation facilities an observation study | | No Sponsor | 11-08-2020 | 20200811 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43763 | Not Recruiting | No | | | | 01-09-2020 | 100 | Observational | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Brajesh Kumar Ratre→ | | D-116, second floor, D Block, East of kailash, New Delhi Room no 242, second floor
Dr BRA IRCH, AIIMS,
New Delhi 110029→ | brajesh.ratre@gmail.com→ | 8696156799→ | All India Institute of Medical Sciences→ | Inclusion criteria: 1. COVID positive patients admitted in isolation facility at NCI Jhajjar having a digital communication (i.e. whatsapp/facebook) enabled smartphone. <br/ ><br>2. Health care staff (Doctors and nurses) posted in the COVID isolation facility. <br/ ><br>3. Willing to participate in study. <br/ ><br>4. Basic knowledge of digital communication.→ | Exclusion criteria: 1. Inability to understand Hindi or English. <br/ ><br>2. Not willing to participate in study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: Not application: not applicable<br>→ | patient and health care workers satisfaction with digital communicationTimepoint: at the time of discharge for patient and at the end of posting of health care workers→ | | | | Yes | False | | |
| → | CTRI/2020/08/027102 | 27 January 2021 | Colchichine use for preventing COVID infection in haemodialysis patients | Pilot study to assess the feasibility of colchicine for COVID prophylaxis in patients with end stage renal disease on haemodialysis | | Dr Krishna Kishore C | 13-08-2020 | 20200813 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45658 | Not Recruiting | No | | | | 15-08-2020 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2 | India→ | DrAlben Sigamani→ | | Mazumdar Shaw Medical
Center, Narayana Hrudayalaya Ltd., NH Health City, 258/A
Bommasandra Industrial Area, Anekal Tulak, Bangalore
Bangalore
→ | krishna.kishore.dr@narayanahealth.org→ | 9980900555→ | Mazumdar Shaw Medical Center, Narayana Health city→ | Inclusion criteria: 1.Patients between 18 to 65 years of age of either gender with end stage renal disease on regular dialysis <br/ ><br>2.Willing to give informed consent→ | Exclusion criteria: 1.Pregnant and lactating women <br/ ><br>2.Patients on CYP3A4 inhibitors and P- glycoprotein inhibitors <br/ ><br>3.Patients with known blood dyscrasias such as myelosuppression, leukopenia, granulocytopenia, thrombocytopenia and aplastic anemia <br/ ><br>4.Patients with Hepatitis B, ,Hep.C positive status and liver disorders <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Colchicine tablet: Patients in this group will be given tablet colchicine at a loading dose of 1 mg followed by 0.5 mg oral thrice a week for 6 months and standard care for ESRD as routinely done<br><br>Control Intervention1: Control group: Patients in control group will continue dialysis and other standard treatment for renal disease as before<br>→ | 1.Feasibility outcomes will be time taken to recruit 100 patients and compliance for colchicine <br/ ><br>2.Safety outcome includes treatment emergent adverse effects due to study drug and cessation of study drug due to adverse events <br/ ><br>3. Efficacy outcome includes incidence of COVID infection between the 2 groups. <br/ ><br>Timepoint: 6 Months <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/08/027106 | 27 January 2021 | TO EVALUATE EFFICACY AND SAFETY OF â??VIRACIDEâ??
IN THE MANAGEMENT OF CORONA VIRUS DISEASE 2019 (COVID-19)
| A PROSPECTIVE,RANDOMIZED, DOUBLE BLIND, PARALLEL DESIGN, PLACEBO CONTROLLED STUDY TO EVALUATE SAFETY AND EFFICACY OF "VIRACIDE" IN THE MANAGEMENT OF CORONA VIRUS DISEASE (COVID19)
| | Natural Supplemets LLC | 13-08-2020 | 20200813 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44639 | Recruiting | No | | | | 20-08-2020 | 120 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Mr Sohal Pendse→ | | 102 A/B, 1st Floor, Park Plaza, near State Bank Colony, Karve Nagar, Pune, Maharashtra 411052 → | v.deshmukh@prorelixresearch.com→ | 020-25478064→ | ProRelix Research→ | Inclusion criteria: 1. 50 years or older <br/ ><br>2. Both male and female subjects will be included <br/ ><br>3. Positive oropharyngeal/nasal swab RT-PCR for Sars-Co-V2. Diagnosed not more than 2 days ago (diagnosis â?¤2days). <br/ ><br>4. Either asymptomatic or have mild symptoms. Onset of symptoms within no more than 4 days If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.50С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) ( <10mg/L). There are no signs of dehydration, sepsis or shortness of breath. <br/ ><br>5. Chronic stable medical conditions: diabetes mellitus, or hypertension, or chronic heart disease. Under treatment and controlled by medication <br/ ><br>6. Signed informed consent/or consent given through text message, WhatsApp or e-mail. <br/ ><br>7. Ability to understand the requirements of the Research Protocol and follow the research procedures. <br/ ><br>8. Subject should be willing to be managed in isolation wards <br/ ><br>9. Negative pregnancy test (for female participants) <br/ ><br>10. Adequate contraception for study duration <br/ ><br>→ | Exclusion criteria: 1. Less than 50 years <br/ ><br>2. With severe COVID-19 symptoms requiring immediate hospitalization <br/ ><br>3. Investigator considers the subject unsuitable for ViraCide <br/ ><br>4. History of symptoms of more than 4 days <br/ ><br>5. COVID-19 diagnosed >2 days ago using oropharyngeal/nasal swab RT-PCR for Sars-Co-V2 <br/ ><br>6. History of cardiopulmonary resuscitation <br/ ><br>7. Subjects having history of organ failure or conditions requiring ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation or any other condition that in the PIâ??s opinion makes the subject unfit to participate <br/ ><br>8. Respiratory failure, ARDS or need of mechanical ventilation <br/ ><br>9. History of acute exacerbation of comorbidity like heart failure, diabetic kedoacidosis, myocardial infection, major cardiac rhythm disorder or any other condition that in the PIâ??s opinion makes the subject unfit to participate <br/ ><br>10. History of or current hepatic failure or severely compromised liver function, or renal failure or having chronic kidney disease or acute renal failure <br/ ><br>11. History of or currently receiving treatment for an endocrine disorder like hypothyroidism, hyperthyroidism that is likely to affect the basal heart rate. <br/ ><br>12. History of or currently under treatment for asthma [exception: patients with history of asthma, not on medications/inhalers/nebulizers for at least 6 months before study start), COPD, bronchiectasis, asbestosis and other such chronic lung conditions that can compromise SpO2 and RR. <br/ ><br>13. HIV, HBsAg, HCV positive <br/ ><br>14. Any condition causing immunodeficiency <br/ ><br>15. Systemic connective tissue disease or any autoimmune disease that is likely to affect HS-CRP levels <br/ ><br>16. History of epilepsy/epileptic fit/convulsions in last 6 months or currently on treatment for it <br/ ><br>17. History of or currently having malignancy and being treated for it. (exception: histologically confirmed and cured carcinoma in situ) <br/ ><br>18. Hypersensitivity reaction to Study drug/placebo <br/ ><br>19. Any psychiatric issue for which the subject is currently undergoing treatment <br/ ><br>20. Any history of drug/alcohol dependence within 30 days of screening or current drug/alcohol dependence <br/ ><br>21. Inability to understand the requirements of the Research Protocol and follow the research procedures. <br/ ><br>22. Pregnant or lactating; <br/ ><br>23. Not willing to use adequate contraception during study duration <br/ ><br>24. Participation in any other clinical study less than 3 months before the start of the study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ViraCide Softgels: ViraCide softgels: 3 soft gels, two times every day after breakfast and dinner for 14 days+ SOC Therapy<br>Control Intervention1: Placebo softgels: Placebo softgels: 3 soft gels, two times every day after breakfast and dinner for 14 days+ SOC Therapy<br>→ | 1. To evaluate the efficacy of â??ViraCideâ?? in the management of mild COVID-19 diseaseTimepoint: Baseline, day 7 and day 15→ | | | | Yes | False | | |
| → | CTRI/2020/08/027109 | 27 January 2021 | Efficacy and safety assessments of BDB-001 injection in treating patients with progressive severe COVID-19 | A multi-center, open-label, randomized parallel controlled evaluation on the efficacy and safety of BDB-001 injection in the treatment of progressive severe COVID-19 in phase II - BDB-001 Covid-19 Study | | Staidson Beijing Biopharmaceutical Co Ltd Beijing Defengrui Biotechnology Co Ltd | 13-08-2020 | 20200813 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44387 | Recruiting | No | | | | 21-08-2020 | 256 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 2 | Russian Federation;Indonesia;Italy;Spain;India→ | Sandesh Brahmankar→ | | George Clinical
Plot No 5 Prestige Khoday Towers 12th Floor Raj Bhavan Road
Bangalore 560 001
Karnataka
India → | sbrahmankar@georgeclinical.com→ | 08049421400→ | George Clinical India Private Limited→ | Inclusion criteria: 8 years old greater than or equal to age lesss than or equal to 80 years old, both men or women. <br/ ><br> <br/ ><br>Subject with confirmed severe COVID19 in less than 5 days who meets any of the following criteria <br/ ><br> <br/ ><br>Respiratory distress RRgreater than or equal to 30 times per min <br/ ><br>In resting state finger oxygen saturation lesss than or equal 93 percent <br/ ><br>Oxygenation Index PaO2 to FiO2 lesss than or equal 300 mmHg 1 mmHg equals 0.133kpa in supine position <br/ ><br>Pulmonary imaging shows lesion progression >50% within 24 â?? 48 hours <br/ ><br> <br/ ><br> <br/ ><br>The informed consent signed→ | Exclusion criteria: Details <br/ ><br>Subjects who meet any of the following criteria cannot be enrolled in this trial <br/ ><br> <br/ ><br>Subjects already progressed into COVID19 critically severe type (including respiratory failure requiring mechanical ventilation, or shock, or combined with other organ failure) or sepsis and sepsis shock. <br/ ><br> <br/ ><br>History of severe lung disease, such as chronic obstructive pulmonary disease (moderate to severe type), lung cancers, tuberculosis; history of severe heart disease, unstable angina pectoris, myocardial infarction, postcardiac surgery, cardiac function â?¥grade 3 (NYHA Classification); history of severe liver disease (e.g. Child Pugh score â?¥grade C); history of severe kidney disease, such as renal insufficiency (GFR â?¤ 15ml/min/1.73m2); immune deficiencies or immune-related diseases: including some autoimmune diseases, IgG4-related diseases, allergic alveolitis, vasculitis; malignancies. <br/ ><br> <br/ ><br>Clear diagnosis of combining bacterial and fungal infections which would disturb the study resultsaccording to the opinion of the investigator. <br/ ><br> <br/ ><br>Subjects on current treatment with a complement inhibitor such as eculizumab. <br/ ><br> <br/ ><br>Subjects with a history of hypersensitivity to any ingredient contained in the study drug <br/ ><br> <br/ ><br>A subject has used the following drugs within 2 weeks (including 2 weeks) prior to screening procedures: <br/ ><br> <br/ ><br>Calcineurin inhibitors (e.g., ciclosporin, tacrolimus,etc.) <br/ ><br>Immunosuppressant (e.g., everolimus, sirolimus,etc.) <br/ ><br> <br/ ><br>Anti-metabolic drugs (e.g., mycophenolate mofetil, mycophenolate, purine sulphate, etc.) <br/ ><br> <br/ ><br> <br/ ><br>Pregnant or lactating women, Positive serum pregnancy test at screening in women of child-bearing potential. A woman is considered of childbearing potential, i.e. fertile, following menarche (first menstrual cycle) and until becoming post-menopausal unless permanently sterile: permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. Women of child-bearing potential must abstain from sexual intercourse or use effective birth control methods for 1 month after their participation in the study ends. Men with a female partner capable of having children must abstain from sexual intercourse or use effective birth control methods for 3 months after their participation in the study ends. Such methods include: <br/ ><br> <br/ ><br>Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal) <br/ ><br> <br/ ><br>Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable) <br/ ><br> <br/ ><br>Intrauterine device <br/ ><br> <br/ ><br>Intrauterine hormone-releasing system <br/ ><br> <br/ ><br>Bilateral tubal occlusion <br/ ><br> <br/ ><br>Vasectomized partner <br/ ><br> <br/ ><br>Any other circumstances that the investigator considers inappropriate for the participation in this study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: BDB-001: Dosing plan: BDB-001 for infusion, 300 mg/person/time, intravenous injection, at days 1, 2, 3, 5,7,9,11, and 13,8 times in total (dosage and frequency of administration can be adjusted according to the progression of the disease).<br><br>BDB-001 is a recombinant humanized anti-human C5a IgG4κ monoclonal antibody for injection, which contains a total of 1328 amino acids and is composed of two heavy chains containing 446 amino acids and two light chains containing 218 amino acids.<br>Control Intervention1: Standard of CARE: Standard of CARE for Management of COVID19 as per National Guidelines will be followed as SOC<br>→ | 1.Percentage of patient number (%) achieved recovery (Oxygenation indexï?³300mmHg from baseline (day 1 prior to investigational drug administration) in supine position OR discharged from hospital). <br/ ><br>2.28-day all-cause mortalityrate <br/ ><br>Timepoint: Day 1, Day 2, Day 3, Day 5, Day 7, Day 9, Day 11, Day 13, Day 14, Day 21, Day 28→ | | | | Yes | False | | |
| → | CTRI/2020/08/027104 | 27 January 2021 | CROSS SECTIONAL RETROSPECTIVE ANALYSIS OF CLINICAL SIGN OF breathlessness in sitting and supine position IN
COVID-19 PATIENTS | CROSS SECTIONAL RETROSPECTIVE ANALYSIS OF CLINICAL SIGN OF PLATYPNEA ORTHODEOXIA IN
COVID-19 PATIENTS | | seth g s medical college | 13-08-2020 | 20200813 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45464 | Not Recruiting | No | | | | 13-08-2020 | 45 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Amita Athavale→ | | SETH G S MEDICAL COLLEGE AND KEM HOSPITAL ,PAREL;MUMBAI 400012 SETH G S MEDICAL COLLEGE AND KEM HOSPITAL ,PAREL;MUMBAI 400012→ | amitaathavale@rediffmail.com→ | 9820104950→ | SETH G S MEDICAL COLLEGE→ | Inclusion criteria: Inclusion criteria: <br/ ><br>1. Records of pulse oximetry values observed during clinical rounds of patients with COVID19 in sitting and supine position from clinical chart -minimum 3 readings will be included. <br/ ><br>→ | Exclusion criteria: Exclusion criteria: 1. non availability of pulse oximetry in sitting and supine positions -orthodeoxia is an uncommon syndrome identified by deoxygenation in sitting or standing position from supine position <br/ ><br>On clinical rounds in COVID-19 patients ward it was observed that a number of patients complained of breathlessness on changing the position from supine to sitting position their oxygen saturation was lower in sitting position as compared to supine position. <br/ ><br>Pulse oximetry is considered as a fifth vital sign for decision making before starting oxygen therapy <br/ ><br>As a standard of care oxygen saturation is monitored using pulse oximeter in admitted patients during clinical rounds. As a number of patients had complained of breathlessness on sitting up in bed or walking towards bathroom ( <100m distance). Oxygen saturation is checked in sitting and supine position for all patients as standard of care. Protocol Version 1.0 Department of Pulmonary Medicine→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B349- Viral infection, unspecified
→ | | Statistical test: â??zâ?? test will be used. <br/ ><br>Primary outcome is to analyse difference, if any, in the oxygen saturation of patients with COVID-19 in sitting and supine position. <br/ ><br>ANCOVA analysis: to analyse the contribution of factors to difference in oxygen saturation in sitting and supine position in patients with COVID-19. cross sectional study <br/ ><br>2weeks <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 2 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/08/027118 | 27 January 2021 | Personal Experience During COVID - 19 Pandemic | Personal Experience During COVID - 19 Pandemic | | NIL | 13-08-2020 | 20200813 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46509 | Not Recruiting | No | | | | 22-08-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Vivian Kapil V→ | | Dept of Psychiatry (Room No 23), Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra Nagar, Porur
Chennai
TAMIL NADU
600116
India → | viviankapil23@gmail.com→ | 9445431311→ | Sri Ramachandra Institute of Higher Education and Research→ | Inclusion criteria: 1. Participants aged 18 years and above. <br/ ><br>2. Willing to participate in the study. <br/ ><br>3. Ability to read, write and understand English language.→ | Exclusion criteria: 1. Participants who are less than 18 years of age. <br/ ><br>2. Participants who are unwilling to participate in the study.→ | | | DASS - 21 scoresTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/08/027112 | 27 January 2021 | Effect of N95 mask in our body study in high volume center | Physiological effect of FFP /PPE in health care workers in a covid intensive care unit in Tertiary care centers - FFP,PPE,health care worker,ICU | | vmmc and safdarjung hospital | 13-08-2020 | 20200813 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46270 | Not Recruiting | No | | | | 18-08-2020 | 80 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Arin Choudhury→ | | Department of anesthesia and critical care,Ansari nagar,
Delhi → | arinchoudhury@gmail.com→ | 7838756566→ | Vmmc and Safdarjung Hospital→ | Inclusion criteria: Subjects should be between 18 to 50 years old health care workers. If HCW have any co-morbid illness it should be noted prior to inclusion→ | Exclusion criteria: any influenza-like illness in the week prior to health care worker should be free from Any viral illness. They will be restricted from working and will be subjected to Covid 19 test. They should not have any haemoglobinopathies such as thalassemia that could interfere with oxygen carriage in the blood. They also should not be consuming alcoholic or smoker→ | | | physiological effects on HCW HR, SPO2,PITimepoint: Baseline,at 4 hours ,at 8 hours,before donning and after doffing→ | | 16/08/2020 | | Yes | False | | |
| → | CTRI/2020/08/027110 | 27 January 2021 | The role of markers(nlr,il-6,d-dimer) in COVID-19 patients and itâ??s co-relationship with oxygenation ,a retrospective observational study in Tertiary care covid ICU | The predictive role of markers in COVID-19 patients and itâ??s co-relationship with spo2/fio2and pao2/fio2 ratio,a retrospective observational study in Tertiary care covid ICU | | Vmmc and Safdarjung Hospital | 13-08-2020 | 20200813 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46271 | Not Recruiting | No | | | | 22-08-2020 | 250 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Arin Choudhury→ | | Department of Anaesthesia
Vmmc and Safdarjung Hospital
Ansari Nagar Vmmc and Safdarjung Hospital
Ansari Nagar→ | arinchoudhury@gmail.com→ | 7838756566→ | Vmmc and Safdarjung Hospital→ | Inclusion criteria: all covid Patient→ | Exclusion criteria: non covid Patient Excluded→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J09X- Influenza due to identified novelinfluenza A virus
Health Condition 3: J111- Influenza due to unidentified influenza virus with other respiratory manifestations
→ | Control Intervention1: nil: nil<br>→ | To identify the level of markers determining outcome of COVID 19 patientTimepoint: baseline,at 1day,3day,6 day ,7 day→ | | | | Yes | False | | |
| → | CTRI/2020/08/027103 | 27 January 2021 | Novel Safe Transport Medium and Rapid RNA Extraction Method for COVID-19 | Evaluation of a Novel Safe Transport Medium for Transportation of Sample and a Rapid Solution-Based RNA Extraction Method for Laboratory Diagnosis of COVID-19 | | BioEra Life Sciences Pvt Ltd Pune | 13-08-2020 | 20200813 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46285 | Not Recruiting | No | | | | 19-08-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Rajesh Karyakarte→ | | Department of Microbiology BJ Government Medical College Pune
Jai Prakash Narayan Road Railway Station Road Pune 411001 → | karyakarte@hotmail.com→ | 9922402502→ | BJ Medical College, Pune→ | Inclusion criteria: Patients admitted in COVID-19 wards→ | Exclusion criteria: Patients on Ventilator→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Safe Transport Medium for Transportation of Sample is effective and safe <br/ ><br>Rapid Solution-Based RNA Extraction Method for Laboratory Diagnosis of COVID-19 is usefulTimepoint: 15 days after the commencement of the study <br/ ><br>1 month after commencement of study that is the end of the study→ | | | | Yes | False | | |
| → | CTRI/2020/08/027120 | 27 January 2021 | A clinical trial to know the efficacy and safety of herbal product Virowin in combination with Energy-Z capsule in treating mild to moderate COVID-19 patients. | An open label, double arm, multicenter, randomized, controlled, clinical study to evaluate the efficacy and safety of an anti-viral polyherbal phytochemical composition Virowin (Mfd. By Amulya Herbs, Haryana) in conjunction with multivitamin Energy Z capsules (Mkt. By Amulya Herbs, Haryana) compared with standard protocol in treating mild to moderate COVID-19 patients. | | Amulya Herbs | 13-08-2020 | 20200813 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46319 | Not Recruiting | No | | | | 20-08-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Dr Parikshit Bansal→ | | Amulya Research Center,
Ground floor, Room Number 05
Plot No 74
HSIIDC, Barwala
Dist. Panchkula
Haryana
INDIA → | info@pharexcelconsulting.com→ | 9878551428→ | Pharexcel Consulting→ | Inclusion criteria: 1. Gender: Either male or non-pregnant, non-lactating female aged > 18-70 < years (both inclusive). <br/ ><br>2. Patients with RT-PCR confirmed diagnosis of COVID-19 <br/ ><br>3. Patients with mild to moderate COVID-19 infection <br/ ><br>4. Subjects willing to give written informed consent <br/ ><br>5. Subjects able to take the Product orally and comply with the study protocol <br/ ><br>6. Women of child bearing potential must have a negative urine pregnancy test prior to study entry→ | Exclusion criteria: 1. Patients with persistent vomiting <br/ ><br>2. Critically ill patients <br/ ><br>3. Patients with known active hepatitis, tuberculosis and definite bacterial or fungal infections <br/ ><br>4. Patients with altered mental state <br/ ><br>5. Patients with multiple organ failure requiring ICU monitoring and treatment <br/ ><br>6. Patients with respiratory failure and requiring mechanical ventilation <br/ ><br>7. Patients with shock <br/ ><br>8. Patients with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results. <br/ ><br>9. Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus. <br/ ><br>10. Patients who have received specific antiviral drugs ritonavir/lopinavir, or chloroquine, hydroxychloroquine, azithromycin, monoclonal antibodies within 1 week before admission <br/ ><br>11. Patient who have participated in another investigational study within 3 months prior to enrolment in this study <br/ ><br>12. Investigators, study personnel, sponsorâ??s representatives and their first-degree relatives. <br/ ><br>13. Pregnant subjects→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Test Product: 2 capsules of Virowin 700 mg capsules, orally, thrice a day for 14 days and 1 capsule of Energy Z capsules, orally, twice a day for 14 days<br>Control Intervention1: Standard Treatment: As per hospital protocol for COVID-19.<br>Dose: As per the hospital policy.<br>→ | 1. Time until cessation of oral shedding of SAARS-CoV-2 virus <br/ ><br>2. Clinical cure based on Clinicianâ??s assessment of symptoms, which include recovery from fever (with or without chills), cough, difficulty in breathing, sore throat, body ache, nasal congestion, gastrointestinal symptoms, fatigueTimepoint: Day1, Day 7 and Day14→ | | 24/11/2020 | | Yes | False | | |
| → | CTRI/2020/08/027166 | 27 January 2021 | Study of stress, depression and anxiety in healthcare workers doing COVID duty | Evaluation of stress, depression and anxiety among healthcare workers doing duty for COVID-19 patients in tertiary healthcare facilities | | GCS Medical College Hospital and Research Center | 14-08-2020 | 20200814 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46395 | Not Recruiting | No | | | | 18-08-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Aatman Parikh→ | | GCS Medical College Hospital and Research Center, Opp. DRM Office, nr. Chamunda bridge, Naroda road, Ahmedabad → | aatmanparikh1@gmail.com→ | 9408276620→ | GCS Medical College Hospital and Research Center→ | Inclusion criteria: Willing to give consent→ | Exclusion criteria: Not willing to participate/give consent→ | | | Prevalence and severity of depression, anxiety and stress among doctors doing COVID-19 duty <br/ ><br>Prevalence and severity of depression, anxiety and stress among para medical staff doing COVID-19 dutyTimepoint: Baseline day0→ | | | | Yes | False | | |
| → | CTRI/2020/08/027163 | 27 January 2021 | Ashwagandha in the prevention of COVID-19 in Health Care workers | A Study of Ashwagandha in the Prophylaxis Against COVID-19 and its Benefits on General Health in High Risk Health Care Workers: A Randomized Controlled Comparison with Hydroxychloroquine Sulphate (HCQS) | | Ministry Of AYUSH CCRAS | 14-08-2020 | 20200814 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46406 | Recruiting | No | | | | 23-08-2020 | 400 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Dr Arvind Chopra→ | | 11, Hermes Elegance,
1988, Convent Street,
Camp. → | crdp5624@gmail.com→ | 9822039297→ | Center for Rheumatic Diseases→ | Inclusion criteria: I. Participants of either sex, 20-65 years of age <br/ ><br>II. Participants testing negative for SARS-CoV-2 by RT PCR technique using nose and throat swab <br/ ><br>III. Participants testing negative for anti-SARS-CoV-2 IgG antibodies <br/ ><br>IV. HCQS naïve participants <br/ ><br>V. Willing to come for regular follow up visits <br/ ><br>VI. Written Informed Consent <br/ ><br>→ | Exclusion criteria: I. Participants with hypersensitivity or intolerance and contraindications(psoriasis, porphyria and Glucose-6-Phosphate Dehydrogenase deficiency) to study drug use <br/ ><br>II. Pregnant women, lactating women and women of child bearing potential not willing to follow adequate contraception <br/ ><br>III. History of having received any investigational drug in the preceding one month <br/ ><br>IV. History of regular intake of Ayurvedic or any other form of CAM (Complementary Alternative Medicine) formulation in the preceding 1 month <br/ ><br>V. Chronic, Severe, Unstable, Uncontrolled medical disease such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders, Retinopathy or other disease of concern which may put the participant at increased risk during the study <br/ ><br>VI. Prolonged concurrent intake of any drug that is known to prolong QT interval on the ECG as per physician discretion and these drugs include anti-arrhythmic drugs, quinidine, chlorpromazine, haloperidol, olanzapine, thioridazine, fluoxetine, antibiotics belonging to quinolone and macrolide family, antibiotics, fenfluramine and other appetite suppressants, Beta-2 agonists, terfenadine and other anti- hitaminic drugs, liquorice and potassium lowering drugs <br/ ><br>VII. Serum Liver Enzymes >1.5 times of upper normal limits, Serum creatinine >2 mg/dL, Blood Urea >70 mg/dL, Blood Hemoglobin <9 gm/dL <br/ ><br>VIII. Non co-operative attitude of the patient <br/ ><br>IX. Any condition or circumstances which in the opinion of the investigator may make a participant unlikely or unable to complete the study or comply with study procedures and requirements <br/ ><br>→ | | Intervention1: Ashwagandha (Withania Somnifera): 250 mg, Dosage schedule:2 tablets BID x 16 weeks<br>Control Intervention1: Hydroxychloroquine: 400 mg BID (twice a day) with meals on Day 1; subsequently, 400 mg once a week with meal for 16 weeks<br>→ | Proportion of participants developing confirmed COVID-19 any time during the duration of the study.Timepoint: week 16→ | | | | Yes | False | | |
| → | CTRI/2020/08/027165 | 27 January 2021 | COVID-19 Global Rheumatology Alliance | Rheumatology COVID-19 registry | | Univesity of California Sanfrancisco | 14-08-2020 | 20200814 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46228 | Not Recruiting | No | | | | 01-09-2020 | 3000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Algeria;Argentina;Australia;Austria;Belgium;Brazil;Canada;Chile;Czech Republic;Denmark;Egypt;Finland;France;Germany;Iceland;India;Iran (Islamic Republic of);Italy;Mexico;New Zealand;Norway;Sweden;United Kingdom;United States of America→ | Sharath Kumar→ | | Columbia Asia Referral hospital, #26/1, Malleshwaram West → | sharath.k@columbiaindiahospitals.com→ | 9663654655→ | Columbia Asia Referral Hospital - Yeshwantpur→ | Inclusion criteria: Patients with Rheumatological autoimmune disease who develop COVID-19→ | Exclusion criteria: None→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: M00-M99- Diseases of the musculoskeletal system and connective tissue
→ | Intervention1: NO INTERVENTION <br>NO COMPARATOR <br>It is an OBSERVATIONAL Study <br>REGISTRY: NO INTERVENTION <br>NO COMPARATOR <br>It is an OBSERVATIONAL Study <br><br>→ | Protective role of HCQS <br/ ><br>Outcomes of COVID infection <br/ ><br>Protective or risk due to other medications <br/ ><br>Risk of bad outcomes due to underlying diagnosisTimepoint: baseline, 2 weeks, 4 weeks,→ | | | | Yes | False | | |
| → | CTRI/2020/08/027162 | 27 January 2021 | A clinical study to understand the effect of Inosine Pranobex in Covid-19 patients when used along with the standard of Care in Covid patients. | An Open-Label, Prospective, Randomized, Comparative, Parallel Group, Multi-Center, Proof of Concept Study to Assess the Efficacy and Safety of Inosine Pranobex Added to Current Standard of Care (CSC) in COVID-19 Patients. | | Themis Medicare | 14-08-2020 | 20200814 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46240 | Not Recruiting | No | | | | 20-08-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2 | India→ | Mr Sangameshwar Iyer→ | | Floor 11/12, Udyog Nagar,S. V. Road, Goregaon (W),
Mumbai → | ashok.swain@themismedicare.com→ | 9160255553→ | Themis Medicare Ltd→ | Inclusion criteria: 1.Written signed and dated informed consent (patient or LAR). <br/ ><br>2.Either gender, in the age group between 18 to 65 years <br/ ><br>3.Patients of laboratory confirmed COVID-19 [nasopharyngeal (preferred) or oropharyngeal swab RT-PCR positive] presenting with WHO listed symptoms of COVID-19 c/o fever, headache, myalgia, cough, throat pain or shortness of breath <br/ ><br>4.A score of between 3 to 5 on the WHO Modified Ordinal Scale for Clinical Improvement (refer protocol appendix 23.1) <br/ ><br>5.SpO2 â?¥90% for adults and respiratory rate â?¤ 30/minute <br/ ><br>6.Patients who provide a agree to abide by the study requirements→ | Exclusion criteria: 1.Known hypersensitivity to any of the ingredients of the study drug <br/ ><br>2.Pregnant and lactating women <br/ ><br>3.Children <18 yrs. of age; elderly >65 years <br/ ><br>4.SpO2 <90% for adults and respiratory rate >30/minute <br/ ><br>5.History of gout or hyperuricemia (serum uric acid level >6mg/dl), urolithiasis, nephrolithiasis or any degree of renal dysfunction <br/ ><br>6.Patients with history of diagnosed primary congenital immunodeficiency, or acquired immunodeficiency like HIV, OR any Genetic or developmental anomaly like Cerebral Palsy, coeliac disease, lactose intolerant, cancer in nor remission stage. <br/ ><br>7.Patient who are undergoing treatment with xanthine oxidase inhibitors, uricosuric agents, diuretics, immunosuppressive agents or zidovudine. <br/ ><br>8.Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases. <br/ ><br>9.Patients simultaneously participating in another clinical study. <br/ ><br>10.Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study <br/ ><br>11.A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tab. Inosine Pranobex 500 mg in addition with Standard of Care: [Synonyms of API: Inosine Acedoben Dimepranol (INN), Methisoprinol, Isoprinosine]<br><br>Dose: 500 mg<br>Route: Oral<br>Frequency: 2 Tabltes Four Times in a day.<br>Control Intervention1: Standard of Care: Standard of Care as per Investigator discretion<br>→ | Percentage of patients with 2 points improvement or becoming asymptomatic (Grade 2 or less) on the modified WHO ordinal scale for clinical improvement between two groups at day 14Timepoint: at Day 14→ | | | | Yes | False | | |
| → | CTRI/2020/08/027168 | 27 January 2021 | Clinical trial study to investigate safety and efficacy of ImmunoSEB and ProbioSEB | A randomized, open label, 2 Arm, prospective study to investigate the safety and efficacy of the health supplements ImmunoSEB+ProbioSEB CSC3 as supplemental therapy in confirmed mild to moderate COVID-19 patients. | | SRV Hospital | 14-08-2020 | 20200814 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45750 | Recruiting | No | | | | 21-08-2020 | 60 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Dr Abhay Vispute Shantaram→ | | SRV Hospital, Dr Mandakini Parihar Marg opposite Lokmanya Tilak Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra SRV Hospital, Dr Mandakini Parihar Marg opposite Lokmanya Tilak Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra→ | drasv.surgiciansrv@gmail.com→ | | SRV Hospital→ | Inclusion criteria: 1.Patient who provides written informed consent <br/ ><br>2.Male or non-pregnant, non-lactating female aged â?¥ 18 and â?¤ 75 years (both inclusive) <br/ ><br>3.RT-PCR confirmed diagnosis of COVID-19 <br/ ><br>4.Able to take the drug orally and comply with study procedures <br/ ><br>5.Women of childbearing potential must have a negative urine pregnancy test prior to study entry <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Severe Type <br/ ><br>Respiratory distress, RRâ?¥30 times/min <br/ ><br>Finger oxygen saturation â?¤93% in rest state <br/ ><br>Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation FiO2 â?¤300mmHg <br/ ><br>2. Critical type: meeting any of the following criteria <br/ ><br>Respiratory failure occurs and mechanical ventilation is required <br/ ><br>Patients go into shock <br/ ><br>ICU is needed for other organ failure. <br/ ><br>3.Patients who have received tumor immunotherapy such as PD-1/L1 CTLA4 etc. in the past 1 month, and inflammatory factor modulators such as Ulinastatin. <br/ ><br>4.other viral pneumonia <br/ ><br>5.patients who have received tumor immunotherapy in tha past one month and inflammatory factor modulators such as Ulinastatin <br/ ><br>6. patients who have received organ transplantation or surgery planning in the past 6 months <br/ ><br>7. patients who cant take food or drugs due to coma or intestinal obstruction <br/ ><br>8.Patients who have severe underlying diseases that affects survival, including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding, severe malnutrition, etc <br/ ><br>9.Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period <br/ ><br>10.Allergic to systemic enzyme supplements <br/ ><br>11.Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal, or patients with child-Pugh grade C cirrhosis <br/ ><br>12.ECLS (ECMO, ECCO2R, RRT) <br/ ><br>13.Imminent death in the opinion of the clinical team <br/ ><br>14.Patients who have participated in any other clinical study within 2 weeks prior to randomization <br/ ><br>15.15. The investigator concludes that the patient is not suitable for the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ImmunoSEB plus ProbioSEB CSC3: ImmunoSEB Capsule / 500 mg 2 capsule bid and <br>ProbioSEB CSC3 Capsule / 5 billion CFUs 2 Capsule OD for 14 days<br>Control Intervention1: Standard Care: standard care given as per institutional practice<br>→ | Proportion of patients showing clinical improvementTimepoint: Proportion of patients showing clinical improvement time frame day 14 from the baseline visit→ | | | | Yes | False | | |
| → | CTRI/2020/08/027164 | 27 January 2021 | National Clinical Registry of COVID 19 | National Clinical Registry of COVID 19 | | Indian Council of Medical Research | 14-08-2020 | 20200814 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46320 | Not Recruiting | No | | | | 17-08-2020 | 10000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Anup Agarwal→ | | V Ramalingaswami Bhawan Ansari Nagar → | covidclinical.registry@gmail.com→ | | Indian Council of Medical Research→ | Inclusion criteria: Hospitalized, COVID-19 confirmed patient of any age and gender. <br/ ><br> <br/ ><br>→ | Exclusion criteria: Hospitals which are not admitting Covid-19 patients→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Weekly reports - clinical reports from the registry data will be <br/ ><br>published on ICMR/MOHFW Website. <br/ ><br>Timepoint: 1 week→ | | | | Yes | False | | |
| → | CTRI/2020/08/027170 | 27 January 2021 | Study to check the safety and immune response of a COVID-19 vaccine in healthy Indian adults. | A Phase 2/3, Observer-Blind, Randomized, Controlled Study to Determine the Safety and Immunogenicity of Covishield (COVID-19 Vaccine) in Healthy Indian Adults - ICMR/SII-COVISHIELD | | Serum Institute of India Private Limited | 15-08-2020 | 20200815 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46186 | Not Recruiting | No | | | | 24-08-2020 | 1600 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 2/ Phase 3 | India→ | Dr Prasad Kulkarni→ | | Serum Institute of India Private Limited,
212/2, Hadapsar, Pune â?? 411 028, India → | drpsk@seruminstitute.com→ | 00912026602949→ | Serum Institute of India Private Limited→ | Inclusion criteria: 1. Healthy adults aged more than or equal to 18 years of either sex. <br/ ><br>2. Written informed consent by participants. <br/ ><br>3. The participant is resident of the study area and is willing to comply with study protocol requirements. <br/ ><br>4. Healthy, as determined by medical history and physical examination. <br/ ><br>5. Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration.→ | Exclusion criteria: 1. Acute illness with or without fever at the time of study vaccine administration <br/ ><br>2. History of laboratory confirmed COVID-19 disease in household contact or close workplace contact <br/ ><br>3. IgG seropositivity to SARS-CoV-2 <br/ ><br>4. History or currently positive for SARS-CoV-2 by RT-PCR <br/ ><br>5. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines <br/ ><br>6. Any confirmed or suspected condition with impaired/altered function of immune system→ | | Intervention1: Covishield (SII-ChAdOx1 nCoV-19): Covishield will be administered as 2 dose schedule on Days 1 and 29 as 0.5 ml dose intramuscularly.<br>Control Intervention1: Oxford/AZ-ChAdOx1 nCoV-19 vaccine: Oxford/AZ-ChAdOx1 nCoV-19 vaccine will be administered as 2 dose schedule on Days 1 and 29 as 0.5 ml dose intramuscularly.<br>Control Intervention2: Placebo: Placebo will be administered as 2 dose schedule on Days 1 and 29 as 0.5 ml dose intramuscularly.<br>→ | 1. Occurrence of causally related SAEs throughout the study duration following vaccination <br/ ><br>2. Ratio of GMTs <br/ ><br>of anti-S IgG antibodiesTimepoint: 1. Throughout the study duration following vaccination <br/ ><br>2. 28 days after the second <br/ ><br>vaccination→ | | | | Yes | False | | |
| → | CTRI/2020/08/027169 | 27 January 2021 | Disease Profile of Covid-19 in patients admitted at AIIMS, Rishikesh | To study the Disease Profileof Covid-19in patients at AIIMS, Rishikesh with focus on the demographical, clinical, laboratory, treatment, and outcome variablesâ?? a cross-sectional study (also known as â??DPC19 â?? AIIMS Rishikeshâ?? study) - DPC19 study | | AIIMS Rishikesh | 15-08-2020 | 20200815 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46255 | Not Recruiting | No | | | | 25-08-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Prasan Kumar Panda→ | | Department of General Medicine, Sixth Floor, College Block, AIIMS Rishikesh
→ | prasan.med@aiimsrishikesh.edu.in→ | 9868999488→ | AIIMS, Rishikesh→ | Inclusion criteria: 1. All RT-PCR/Antigen lateral flow chromatographic immunoassay positive Covid-19 cases (Adult >18years) for next two years <br/ ><br>2. Patient medical records available from April 2020 to present time for retrospective cohort <br/ ><br>→ | Exclusion criteria: 1. Positive cases who have been admitted in other than Covid area where infectious disease reference has not been sorted→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1)Demographic details <br/ ><br>2)Detailed History and physical examination findings <br/ ><br>3)All laboratory investigations and imaging findings <br/ ><br>4)Treatment and outcome detailsTimepoint: at baseline→ | | | | Yes | False | | |
| → | CTRI/2020/08/027171 | 27 January 2021 | Measurement of renal biomarker in COVID-19 associated acute renal failure | Renal Biomarkers of Injury as Early Predictors of COVID-19 associated AKI: A Prospective observational institute based Trial - BRICOAKI TRIAL | | AIIMS Patna | 15-08-2020 | 20200815 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46527 | Not Recruiting | No | | | | 25-08-2020 | 75 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Neeraj Kumar→ | | Trauma and Emergency
Room No;503,5th Floor
New OT Complex
B Block
AIIMS Patna
Trauma and Emergency
Room No;503,5th Floor
New OT Complex
B Block
AIIMS Patna
→ | drneerajk@aiimspatna.org→ | 8210104972→ | All India Institute of Medical Sciences,Patna→ | Inclusion criteria: 1.RT PCR proved COVID-19 positive patients admitted in AIIMS Patna <br/ ><br>2.Age 18-65 years <br/ ><br>3.Clinical Category of Patients <br/ ><br>A.Mild category <br/ ><br>B.Moderate category <br/ ><br>C.Severe category <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1.Pre-existing AKI <br/ ><br>2.Severe chronic kidney disease (CKD) with estimated glomerular filtration rate (e-GFR) < 20 ml/min <br/ ><br>3.End-stage renal failure on regular dialysis <br/ ><br>4.Kidney transplant within the last 12 months <br/ ><br>5.Pregnancy <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Daily measurement of urinary and plasma renal biomarkers: Daily measurement of urinary and plasma renal biomarkers in a COVID-19 positive patients with moderate-severe respiratory symptoms<br>Control Intervention1: Daily measurement of urinary and plasma renal biomarkers: Daily measurement of urinary and plasma renal biomarkers in a COVID-19 positive patients with mild respiratory symptoms<br>→ | 1.Relation of these renal biomarkers with progression to any stage of acute kidney injury <br/ ><br>As defined by Kidney Diseases: Improving Global Outcome (KIDGO) <br/ ><br>Timepoint: For Milder group time points will be on Baseline 0 Day, 3rd Day and 10th Day or on the day of clinical deterioration <br/ ><br>For Moderate to severe group <br/ ><br>on Day 0 (baseline), 1st Day, 2nd Day,3rd Day, 5th Day,7th Day and 10th Day. <br/ ><br> <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/08/027175 | 27 January 2021 | Clinical profile of neonates born to mothers with COVID-19 | A study on the clinical profile of neonates born to mothers with COVID-19 | | Government | 15-08-2020 | 20200815 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44760 | Not Recruiting | No | | | | 30-08-2020 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ambili Susan Jacob→ | | Department of Pediatrics
Government Medical college,Kannur → | ambilisusanjacob@gmail.com→ | 9447664165→ | Government Medical College,Kannur→ | Inclusion criteria: All neonates born to mothers with COVID-19→ | Exclusion criteria: neonates born to mothers taking teratogenic drugs, <br/ ><br> exposure to teratogenic dose of radiation, infections like varicella and TORCH and addictions like smoking and alcoholism→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Clinical outcome,Congenital anomaliesTimepoint: Immediate, Follow up for 28 days of life→ | | | | Yes | False | | |
| → | CTRI/2020/08/027174 | 27 January 2021 | Psychological Impact of COVID 19 on frontline health care workers | Psychosocial impact and coping strategies of frontline healthcare workers in Western Rajasthan during COVID-19 pandemic | | Aiims Jodhpur | 15-08-2020 | 20200815 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45547 | Not Recruiting | No | | | | 20-08-2020 | 500 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | KAMLESH KUMARI→ | | Department of Anaesthesiology and Critical Care, AIIMS Jodhpur Department of Anaesthesiology and Critical Care, AIIMS Jodhpur→ | kamlesh.gmch@gmail.com→ | 9780040150→ | AIIMS JODHPUR→ | Inclusion criteria: All frontline health care workers (Doctors and Nursing Staff) who have done COVID duties wearing PPE KIt→ | Exclusion criteria: Frontline health care workers working in COVID Suspect areas without PPE Kit→ | | Intervention1: NIL: NIL<br>→ | To know the sources of stress, psychosocial impact and coping strategies amongst frontline HCW working in PPE suit in western Rajasthan during the COVID-19 outbreakTimepoint: 10 Days after mailing online Google form→ | | | | Yes | False | | |
| → | CTRI/2020/08/027173 | 27 January 2021 | Necessary measures taken for covid positive pregnant women during pandemic. | "A Systematic literature review of clinical presentation and management of obstetric pateints during covid 19 pandemic" | | Shrideevi Kori | 15-08-2020 | 20200815 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46063 | Not Recruiting | No | | | | 15-08-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | DR SHREEDEVI KORI→ | | OPD NO 2
DEPT OF OBG
BLDE HOSPITAL, BIJAPUR - 586103 → | shreedevi.kori@bldedu.ac.in→ | 9538846839→ | BLDE HOSPITAL AND RESEARCH HOSPITAL→ | Inclusion criteria: PREGNANT WOMEN WITH COVID -19 POSITIVE→ | Exclusion criteria: NON COVID PREGNANT WOMEN→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | OUTCOME WILL BE ORGANISED IN THE FOLLOWING CATEGORY:CLINICAL PRESENTATION, MATERNAL OUTCOMES, PERINATAL OUTCOMESTimepoint: OUTCOME WILL BE ORGANISED IN THE FOLLOWING CATEGORY:CLINICAL PRESENTATION, MATERNAL OUTCOMES, PERINATAL OUTCOMES AFTER A MONTH <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/08/027172 | 27 January 2021 | Clinical Profile and Outcome of Neonates Born to Mothers with COVID in a Tertiary Care Centre | Clinical Profile and Outcome of Neonates Born to Mothers with COVID in a Tertiary Care Centre | | nil | 15-08-2020 | 20200815 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46077 | Not Recruiting | No | | | | 16-08-2020 | 40 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Thinesh Kumar J→ | | Department of Neonatology
Sri Ramachandra Institute of Higher Education and Research
Porur, Chennai → | dr.thineshkumar@gmail.com→ | 9840070508→ | SRMC University→ | Inclusion criteria: Newborn babies born to mother with confirmed COVID19 between 14 days before delivery and 2 days after delivery→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | To study the clinical profile and outcome of neonates born to mothers with COVID19 in a tertiary care centerTimepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/08/027192 | 27 January 2021 | to assess the impact of COVID-19 pandemic on the delivery of radiation therapy in delhi national
capital region, india | impact of COVID-19 pandemic on the delivery of radiation therapy in delhi national
capital region, india | | Dr Rashi Agarwal | 17-08-2020 | 20200817 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45344 | Not Recruiting | No | | | | 22-08-2020 | 500 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Rashi Agrawal→ | | 6th Floor,New Building,Max Super Speciality Hospital,A Unit of Crosslay Remedies Ltd.,W-3,Sector-1,Vaishali 6th Floor,New Building,Max Super Speciality Hospital,A Unit of Crosslay Remedies Ltd.,W-3,Sector-1,Vaishali→ | drrashi.ag@gmail.com→ | 9813681889→ | Max Super Speciality Hospital,A Unit of Crosslay Remedies Ltd.→ | Inclusion criteria: 1. Diagnosed with cancer <br/ ><br>2. Those who started radiotherapy between Jan 1 st 2020 to May 31 th 2020→ | Exclusion criteria: Those who started radiotherapy before Jan 1 st 2020 and after May 31 th 2020→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Percentage change in number of patients starting radiation treatment during this time <br/ ><br>period <br/ ><br> <br/ ><br>We will compare the interval between last scheduled cancer directed treatment (surgery or <br/ ><br>neoadjuvant chemo) and the start of radiation therapy or interval between date of diagnosis <br/ ><br>and start of radiation therapy if radiation being first treatment between pre COVID time <br/ ><br>(Jan 1 st 2020 â?? 22nd March 2020) and during COVID time (23rdMarch 2020- 31 st May 2020).Timepoint: 5 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027193 | 27 January 2021 | Impact of COVID -19 situation on people staying and discharged from a psychiatric rehabilitation centre | Strategies used in a psychiatry rehabilitation centre during COVID-19 period and its impact on clients continuing their stay vs those discharged â?? A Retrospective follow up study | | Department of Psychiatry | 17-08-2020 | 20200817 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46646 | Not Recruiting | No | | | | 31-08-2020 | 54 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rajeshkrishna Bhandary P→ | | Manipal Academy of Higher Education, Madhav Nagar, Manipal → | rajesh.kbp@manipal.edu→ | 9844542567→ | Kasturba Medical College, Manipal→ | Inclusion criteria: #1. All patients with mental illness who were residing at the specified rehabilitation centre in March 2020 when lockdown was announced. <br/ ><br> <br/ ><br>#2. Both those who continued stay and those who were temporarily discharged in view of the lockdown.→ | Exclusion criteria: Those whose files lack information on the outcome at 3 months (June 2020)→ | Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
→ | | Occurrence of relapse, recurrence of nay symptoms and concerns during the periodTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027194 | 27 January 2021 | Relation between HLA typing and ABO Blood group to infection by novel Wuhan Corona virus. | Association of HLA typing and ABO Blood group to SARS-CoV-2 infection and its correlation to disease pattern and clinical severity â?? a single centre study from South India | | Christian Medical College | 17-08-2020 | 20200817 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44119 | Not Recruiting | No | | | | 25-08-2020 | 80 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Snehil Kumar→ | | Department of Transfusion Medicine and Immunohaematology,
5th floor ASHA building,
Christian Medical College and Hospital, Vellore.
→ | snehilsimulation25@gmail.com→ | 9734382865→ | Christian Medical College→ | Inclusion criteria: Suspected COVID-19 cases and positive or negative on testing and who give consent→ | Exclusion criteria: Non consenting patients→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: Nil<br>Control Intervention1: Nil: Nil<br>→ | This study may discover the genetic factors that may play a central role in determining various clinical phenotypes.Timepoint: At baseline→ | | | | Yes | False | | |
| → | CTRI/2020/08/027189 | 27 January 2021 | Role of chest CT scan in covid19 patients: A study in a dedicated covid hospital of odisha | Evaluation of hrct chest in covid19 patients: A study in a dedicated covid hospital of Odisha - HRCT chest in covid19 | | Department of radiodiagnosis | 17-08-2020 | 20200817 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46430 | Not Recruiting | No | | | | 20-08-2020 | 1600 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sangram Panda→ | | Department of Radiodiagnosis
KIMS hospital
KIIT university campus Patia
Bhubaneswar→ | sangram.aju@gmail.com→ | 9090790794→ | Kalinga institute of medical sciences (kims)→ | Inclusion criteria: All COVID19 positive patients who were admitted in KIMS COVID hospital and had undergone HRCT chest.→ | Exclusion criteria: Clinically suspected COVID cases who were negative on RT-PCR testing. <br/ ><br>COVID positive patients, who had not undergone HRCT chest. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | To observe and analyse the imaging characteristics of covid19 pneumonia in hrct chest. <br/ ><br>To study the changes in hrct findings of covid19 pneumonia during the course of disease. <br/ ><br>Timepoint: 3 MONTHS <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/08/027224 | 27 January 2021 | To observe the effect of Ayurvedic medicine (Ashwagandha and Shunti) for the treatment of COVID-19 | A Prospective Randomized Controlled Clinical Trial to evaluate the Efficacy and Safety of Ayurveda Interventions (Ashwagandha Tablet and Shunti Capsule) in the management of COVID-19 infection (Mild to Moderate symptoms) | | Central Council for Research in Ayurvedic Sciences New Delhi | 18-08-2020 | 20200818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46608 | Not Recruiting | No | | | | 25-08-2020 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Sumit Shrivastva→ | | 77, Chandi Path, Sector 46B, Room No. 116, Ground floor, Shri Dhanwantry Ayurvedic Hospital→ | sumitpankaj@gmail.com→ | 9781110780→ | Shri Dhanwantry Ayurvedic College and Hospital→ | Inclusion criteria: 1. Mild to moderate cases registered in the Hospital, with COVID 2019 (Confirmed by Antigen test/ RT-PCR) quarantined at identified hospital set up. <br/ ><br>2. Participants who can take medicines orally <br/ ><br>3. Patients with either sex, 18 to 75 years age <br/ ><br>4. Patients willing to provide signed informed consent <br/ ><br>→ | Exclusion criteria: 1. Cases of severe vomiting which would make oral administration of medicine difficult. <br/ ><br>2. Patients with hyperacidity and gastric ulcer to be excluded. <br/ ><br>3. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study <br/ ><br>4. Cases of respiratory failure and requiring mechanical ventilation. <br/ ><br>5. Patients with COVID 19 in critical condition or ARDS or NIAD 8 â??point ordinal score 2 Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation <br/ ><br>6. Pregnant or lactating women <br/ ><br>7. Any patient with proved sensitivity to the trial drugs may be excluded. <br/ ><br>8. Any other condition, which as per the investigator would jeopardize the outcome of the trial. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ashwagandha tablet and Shunti capsule: a. Ashwagandha Tablet <br>Dose: 2 Tablets 250mg each( twice daily)<br>Dosage form: Tablets <br>Route of Administration:Oral<br>Time of Administration: Twice a day 2 hrs after food<br>Anupana:Water <br>Duration of therapy: 15 days<br>b. Shunti Capsule <br>Dose: 2 capsules 500 mg each (twice daily 2-0-2)<br>Dosage form: Capsule<br>Route of Administration:Oral<br>Time of Administration: Twice a day atleast 30 minutes after food<br>Anupana: Water <br>Duration of therapy:15 days<br><br>Control Intervention1: Conventional standard therapy for COVID-19 positive patients: Conventional standard therapy as per ICMR guidelines<br>→ | 1. Clinical cure rate: Time to negative conversion of severe acute respiratory syndrome corona-virus 2.(From the day of randomization)Timepoint: On 7th day and 15th day→ | | | | Yes | False | | |
| → | CTRI/2020/08/027225 | 27 January 2021 | Ivermectin as a possible treatment for COVID-19 | Ivermectin as a potential treatment for COVID 19: A double blind randomized placebo-controlled trial | | AIIMS Patna | 18-08-2020 | 20200818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46660 | Not Recruiting | No | | | | 28-08-2020 | 90 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | N/A | India→ | Ravi Kirti→ | | Department of General Medicine
1st Floor, OPD Building
AIIMS, Phulwari Sharif
Patna → | drravikirti@aiimspatna.org→ | 9572424447→ | All India Institute of Medical Sciences→ | Inclusion criteria: Patients admitted with COVID-19 with mild to moderate severity→ | Exclusion criteria: History of allergy to Ivermectin <br/ ><br>Unwillingness to participate in the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ivermectin: 12 mg orally to be administered once daily on days 1 and 2<br>Control Intervention1: Placebo tablets: A placebo tablet similar to Ivermectin 12 mg (provided by the manufacturer) to be given once daily on days 1 and 2.<br>→ | Negative RT-PCRTimepoint: Day 6→ | | 31/10/2020 | | Yes | False | | |
| → | CTRI/2020/08/027226 | 27 January 2021 | Study of Radiotherapy practice during Corona Pandemic | Study of Radiotherapy practice during Covid-19 pandemic at Tata Memorial Centre | | Jai Prakash Agarwal | 18-08-2020 | 20200818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46685 | Recruiting | No | | | | 28-08-2020 | 2500 | Observational | Other<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded | N/A | India→ | Jai Prakash Agarwal→ | | Room No.1131,
Department of Radiation Oncology
Tata Memorial Hospital
E Borges Road
Parel East → | agarwaljp@tmc.gov.in→ | 02224177000→ | Tata Memorial Hospital→ | Inclusion criteria: All patients who visited the radiation oncology department at TMH+ACTREC for opinion and treatment <br/ ><br> <br/ ><br>Patients with a cytological or pathological diagnosis of cancer <br/ ><br>→ | Exclusion criteria: Patients visited for second opinion to radiation department→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. To study the impact of Covid-19 pandemic on radiotherapy treatments at a tertiary cancer center <br/ ><br> <br/ ><br>2.To study the change in treatment patterns of radiotherapy practice from the standard practice made in response to the COVID-19 pandemicTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027218 | 27 January 2021 | COVID-19 prevalence during pregnancy and pregnancy outcomes in low resource settings | COVID-19 prevalence during pregnancy and pregnancy outcomes in 8 low and middle-income sites: A Global Network Study | | Eunice Kennedy Shriver National Institute of Child Health and Human Development | 18-08-2020 | 20200818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45967 | Recruiting | No | | | | 01-09-2020 | 16000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Bangladesh;Democratic Republic of the Congo;Guatemala;India;Kenya;Pakistan;Zambia→ | Dr Shivaprasad S Goudar→ | | KLE Academy of Higher Education and Research J N Medical College Nehru Nagar Belgaum Principal Investigator Womens and Childrens Health Research Unit Wing Belgaum → | sgoudar@jnmc.edu→ | 9448126371→ | KLE Academy of Higher Education and Research J N Medical College→ | Inclusion criteria: All women in the Maternal Newborn Health Registry will be eligible to be screened for the COVID-19 study at time of enrollment into the MNHR. This study will follow the same inclusion and exclusion criteria as the MNH Registry (MNHR) to screen <br/ ><br>Pregnant women intending to deliver within study cluster→ | Exclusion criteria: Decline to provide consent to include data in the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Prevalence of COVID-19 antibody positive results during pregnancyTimepoint: Up to 42 days postpartum→ | | | | Yes | False | | |
| → | CTRI/2020/08/027205 | 27 January 2021 | Clinical trial of otilimab in patients with severe pulmonary COVID-19 related disease. | A randomized, double-blind, placebo-controlled, study evaluating the efficacy and safety of otilimab IV in patients with severe pulmonary COVID-19 related disease. - OSCAR study | | GlaxoSmithKline Research and Development Limited | 18-08-2020 | 20200818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45488 | Not Recruiting | No | | | | 21-08-2020 | 800 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 2 | Argentina;Belgium;Brazil;Canada;Chile;Colombia;France;India;Japan;Mexico;Netherlands;Peru;Poland;South Africa;Spain;United Kingdom;United States of America;Russian Federation→ | Rashmi Chitgupi→ | | PPD Pharmaceuticals Development India Private Limited
101, A Wing, Fulcrum, Hiranandani Business Park
Sahar Road, Andheri East, → | rashmi.chitgupi@ppdi.com→ | 91-02266022900→ | PPD Pharmaceuticals Development India Private Limited→ | Inclusion criteria: 1. Age â?¥18 years and â?¤79 years at the time of obtaining informed consent. <br/ ><br>2. Participants must: <br/ ><br>a. have positive SARS-CoV-2 result (any validated test, e.g. RT-PCR [performed on an appropriate specimen; e.g. respiratory tract sample]) <br/ ><br>b. AND be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan consistent with COVID-19) <br/ ><br>c. AND be developing new onset of oxygenation impairment defined as SpO2 â?¤90% on room air <br/ ><br>d. AND requiring any of the following: <br/ ><br>1. high-flow oxygen (â?¥15L/min) <br/ ><br>2. non-invasive ventilation (e.g. CPAP, BiPAP) <br/ ><br>3. mechanical ventilation â?¤48h prior to dose <br/ ><br>e. AND have increased biological markers of systemic inflammation (either CRP >ULN or serum ferritin >ULN). <br/ ><br>3. No gender restriction. <br/ ><br>4. Female participants must meet and agree to abide by the contraceptive criteria detailed in Appendix 4. Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. <br/ ><br>A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies: <br/ ><br>o Is a woman of non-childbearing potential (WONCBP) as defined in Section 9.4: Contraceptive and Barrier Guidance. <br/ ><br>OR <br/ ><br>o Is a woman of childbearing potential (WOCBP) and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 9.4 during the study intervention period and for at least 60 days after the last dose of study intervention (sexual abstinence is acceptable if it is the participantâ??s normal practice). <br/ ><br>o If not consistently on a highly effective method of contraception (Section 9.4) during hospitalization, the participant must agree to a highly effective contraception plan if discharged before Day 60. <br/ ><br>o The investigator should evaluate potential for contraceptive method failure (e.g. Noncompliance, recently initiated) in relation to the first dose of study intervention. <br/ ><br>o A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) at hospital admission or before the first dose of study intervention. See Section 7.3.5 Pregnancy Testing (additional requirements for pregnancy testing during and after study intervention). <br/ ><br>o The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. <br/ ><br>5. Capable of giving written informed consent as described in Section 9.1.3. If participants are not capable of giving written informed consent, alternative consent <br/ ><br>procedures will be followed as detailed in Section 9.1.3. <br/ ><br>→ | Exclusion criteria: 1. Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator. <br/ ><br>2. Multiple organ failure according to the investigatorâ??s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU. <br/ ><br>3. Extracorporeal membrane oxygenation (ECMO) hemofiltration/dialysis, or high dose ( >0.15mcg/kg/min) noradrenaline (or equivalent) or more than one vasopressor. <br/ ><br>4. Current serious or uncontrolled medical condition (e.g. significant pulmonary disease such as severe COPD or pulmonary fibrosis, heart failure [NYHA class III or higher], significant renal dysfunction, acute myocardial infarction or acute cerebrovascular accident within the last 3 months) or abnormality of clinical laboratory tests that, in the investigators judgment, precludes the participants safe participation in and completion of the study. <br/ ><br>5. Untreated systemic bacterial, fungal, viral, or other infection (other than SARSCoV-2). <br/ ><br>6. Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB. <br/ ><br>7. Known HIV regardless of immunological status. <br/ ><br>8. Known HBsAg and/or anti-HCV positive. <br/ ><br>9. Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy. <br/ ><br>10. Received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization, including intravenous immunoglobulin, or planned to be received during the study. <br/ ><br>11. Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors (e.g. baricitinib, tofacitinib, upadacitinib) within the last 3 months prior to randomization or planned to be received during the study. <br/ ><br>Note: Participants with an organ transplant are therefore excluded (except patients with corneal transplants not requiring immunosuppression). <br/ ><br>12. History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy. <br/ ><br>13. Received COVID-19 convalescent plasma within 48 hours of randomization. <br/ ><br>Note: Participants who have received COVID-19 convalescent plasma but continue to worsen in the 48 hours after infusion of the convalescent plasma, in the opinion of the investigator, will become eligible for the study. <br/ ><br>14. Currently receiving chronic oral corticosteroids for a non-COVID-19 related condition in a dose higher than prednisone 10 mg or equivalent per day. <br/ ><br>15. Treatment with an investigational drug within 30 days of randomization. <br/ ><br>16. Participating in other drug clinical trials, including for COVID-19. <br/ ><br>17. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >5x upper limit of normal (ULN). <br/ ><br>18. Platelets <50,000/mm3. <br/ ><br>19. Haemoglobin â?¤9 g/dL. <br/ ><br>20. Absolute neutrophil count (ANC) <1.5 x 10 raised to 9/L (neutropenia â?¥ Grade 2). <br/ ><br>21. Estimated GFR â?¤30 mL/min/1.73meter square. <br/ ><br>22. Pregnant or breastfeeding females.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Otilimab in addition with Standard of care: Fully human anti-GM-CSF monoclonal antibody (mAb),<br>frequency : Once only on day 1,<br><br>Route of administration : IV infusion,<br><br>Duration of therapy : therapy will be administered approximately over 1 hour<br>Control Intervention1: Placebo in addition with Standard of care: Sterile 0.9% (w/v) sodium chloride solution, <br>Frequency: Once only on day 1,<br> <br>Route of administration : IV infusion,<br>Duration of therapy : therapy will be administered approximately over 1 hour<br>→ | To compare the efficacy of otilimab IV versus placeboTimepoint: Participants alive and free of respiratory failure at Day 28→ | | | | Yes | False | | |
| → | CTRI/2020/08/027210 | 27 January 2021 | A backdated comparison of patients operated before the COVID-19 pandemic versus those operated during the COVID_19 pandemic. | Surgical Site Infections in patients undergoing cancer surgery during the COVID-19 pandemic (SCION): A comparative study - SCION | | Tata Memorial Centre | 18-08-2020 | 20200818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46279 | Not Recruiting | No | | | | 19-08-2020 | 3000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Gouri Pantvaidya→ | | Tata Memorial hospital,
HBB 12TH FLOOR. room no.1230, Parel, Mumbai → | docgouri@gmail.com→ | 9833971155→ | Tata Memorial Centre→ | Inclusion criteria: All patients undergoing elective cancer surgery during October to December 2019 and April to June 2020 will be included→ | Exclusion criteria: Emergency procedures <br/ ><br>Non oncologic procedures like wound lavage, re explorations, flap adjustments etc <br/ ><br>Patients with incomplete data <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | SSI identification <br/ ><br>The CDC grading has been used by the DOS to identify SSIs. All SSIs will be classified as per the CDC grading into superficial, deep and organ space infectionsTimepoint: 30 days post operative→ | | | | Yes | False | | |
| → | CTRI/2020/08/027222 | 27 January 2021 | Unani formulations for prevention of COVID-19 infection | Assessment of the role of Unani formulations in prevention of COVID-19 infection in high-risk population. | | Hamdard Laboratories India Medicine Division | 18-08-2020 | 20200818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46308 | Not Recruiting | No | | | | 24-08-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2 | India→ | Mr Ayan Kumar Das→ | | Room no213
Department of Microbiology
Hamdard Institute of Medical Sciences and Research and associated HAHC Hospital → | chandradr795@gmail.com→ | 9953269025→ | Hamdard Institute of Medical Sciences and Research→ | Inclusion criteria: 1. Subjects who have got direct or indirect exposure to RT-PCR positive COVID-19 patient(s) in last 7 days and whose test is negative for COVID-19. <br/ ><br> <br/ ><br>The following high risk subjects will be included in the study; <br/ ><br>a.Touched body fluids of the patient. <br/ ><br>b.Had direct physical contact with the body of the patient including physical examination without PPE. <br/ ><br>c.Touched or cleaned the linens, clothes, or dishes of the patient. <br/ ><br>d.Lives in the same household as the patient. <br/ ><br>e.Anyone in close proximity (within 1 meter) of the confirmed case without precautions. <br/ ><br>f.Passenger in close proximity of a symptomatic patients in a conveyance. <br/ ><br> <br/ ><br> <br/ ><br>2.Subjects without any co-morbidities of either sex aged 18-65. <br/ ><br>3. Agrees not to self-medicate or not to take the prescribed medication with chloroquine, hydroxychloroquine or other potential antivirals/other drug. <br/ ><br>4. Willingness to give informed consent. <br/ ><br>→ | Exclusion criteria: 1.COVID-19 positive patients. <br/ ><br>2.Atopic patients or persons with known allergy to herbal products <br/ ><br>3.Critically ill patients. <br/ ><br>4.Previously diagnosed with COVID-19 <br/ ><br>5.Subjects on other prophylactic medications. <br/ ><br>6.Immune compromised patients <br/ ><br>7.Pregnant and lactating women. <br/ ><br>8.Patients bellow 18 and above 65 years <br/ ><br>9.Patient taking any other herbal medicine or immune-modulatory drugs <br/ ><br>10.Out station patients.→ | | Intervention1: 1. Testing Infuza (2.5 ml given every 12 hourly) for 14 days 2. Testing Kulzam 5 drops in hot water for steam inhalation every 12 hourly) for 14 days 3. 3. Testing Infuza (2.5 ml given every 12 hourly) and Kulzam (5 drops in hot water for steam inhalation every 12 hourly) for 14 days: Group 1: COVID-19 negative cases (RT-PCR) who had close contact with COVID 19 positive patients (RT-PCR) will be treated with Infuza (2.5 ml given orally every 12 hourly) for 14 days <br>Group 2: COVID-19 negative cases (RT-PCR) who had close contact with COVID 19 positive patients (RT-PCR) will be treated with Kulzam (5 drops in hot water for steam inhalation every 12 hourly) for 14 days<br>Group 3: COVID-19 negative cases (RT-PCR) who had close contact with COVID 19 positive patients (RT-PCR) will be treated with Infuza (2.5 ml given orally every 12 hourly) + Kulzam (5 drops in hot water for steam inhalation every 12 hourly) for 14 days.<br>Control Intervention1: control group will follow guidelines of home quarantine: Group 4 (control group): COVID-19 negative cases (RT-PCR) who had close contact with COVID 19 positive patients will follow the guidelines of home quarantine (in isolation without any medication) for 14 days.<br>→ | 1.Rate of COVID-19 positive conversionTimepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/08/027244 | 27 January 2021 | Behavioural and emotional difficulties of school going children during COVID times | Behavioural and Emotional problems in
school going children and adolescents in the context of COVID 19 pandemic | | Dr Subhashish Nath | 19-08-2020 | 20200819 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46157 | Not Recruiting | No | | | | 29-08-2020 | 3500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Subhashish Nath→ | | Department of Psychiatry,
Lokopriya Gopinath Bordoloi Regional Institute of Mental Health, Tezpur → | subhashish.n@gmail.com→ | | Lokopriya Gopinath Bordoloi Regional Institute of Mental Health→ | Inclusion criteria: i.Any child or adolescent aged 4 to 16 years and attending any regular English medium school in Tezpur town. <br/ ><br>ii.Informed written Consent of the principal of any regular English medium school in Tezpur town for agreeing to post the flyer for the study in their social media groups. <br/ ><br>iii.E- Consent of the caregiver for the participation in the study <br/ ><br>iv.E- Assent from the child (wherever applicable) <br/ ><br>v.Caregiver should have reasonable abilities to read, comprehend and respond in English.→ | Exclusion criteria: i.Any child/adolescent whose caregiver cannot be contacted due to any reason <br/ ><br>ii.Any child/adolescent staying in boarding/hostel <br/ ><br>→ | | | Behavioral and Emotional problems in school going children and adolescentsin the context of OVID 19 pandemicTimepoint: At 1 month from last enrollment for Phase 1. <br/ ><br>Further evaluation in Phase 2 for 2 months. <br/ ><br> <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/08/027247 | 27 January 2021 | Lower morbidity and mortality in COVID-19 patients admitted in a dedicated COVID Hospital of Odisha - A Radiological perspective | Lower morbidity and mortality in COVID-19 patients admitted in a dedicated COVID Hospital of Odisha - A Radiological perspective | | Dr Roopak Dubey | 19-08-2020 | 20200819 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46417 | Not Recruiting | No | | | | 20-08-2020 | 1500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Investigator Blinded | N/A | India→ | Dr Roopak Dubey→ | | Department of Radiodiagnosis, Kalinga Institute of Medical Sciences, KIIT road, Patia, Bhubaneswar, PIN code- 751024 → | kamal.sen@kims.ac.in→ | 7064333377→ | Kalinga Institute of Medical Sciences→ | Inclusion criteria: All the COVID positive patients who were admitted to KIMS COVID hospital and underwent HRCT Thorax along with laboratory investigations were enrolled in the study→ | Exclusion criteria: any patient who lacks HRCT thorax or laboratory findings was excluded→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: R99- Ill-defined and unknown cause of mortality
→ | | Radiological findings on HRCT Thorax along with clinical and laboratory findings correlate with the severity of COVID. HRCT thorax is highly sensitive in detecting COVID lesions.Timepoint: 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/08/027243 | 27 January 2021 | Identifying the factors that alters the recovery time of the COVID-19 patients. | Modelling the recovery time of COVID-19 patients- A Survival Analysis | | T Gayathri | 19-08-2020 | 20200819 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46500 | Not Recruiting | No | | | | 11-09-2020 | 500 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | T Gayathri→ | | Department of community medicine
Sri Ramachandra Medical College & RI
SRIHER
Chennai No.1, Ramachandra Nagar, Porur,
Chennai,
Tamil Nadu 600116→ | gayathri.t@sriramachandra.edu.in→ | 9444207470→ | SRIHER→ | Inclusion criteria: Patients with COVID-19 positive→ | Exclusion criteria: COVID-19 negative→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | COVID-19 Recovery timeTimepoint: At the time of discharge i will be noting the time taken for recovery→ | | | | Yes | False | | |
| → | CTRI/2020/08/027246 | 27 January 2021 | Role of Tocilizumab in COVID-19 Pneumonia patients | Role of Tocilizumab in Patients with Moderate to Severe COVID-19 Pneumonia | | GCS Medical College Hospital and Research Centre | 19-08-2020 | 20200819 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46546 | Not Recruiting | No | | | | 01-09-2020 | 40 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Shaila Shah→ | | OPD No.1, General Medicine Department, GCS Medical College, Hospital and Research Centre, Opp DRM Office, Naroda road, Ahmedabad GCS Medical College, Hospital and Research Centre, Opp DRM Office, Naroda road, Ahmedabad→ | shailashah05@gmail.com→ | 9825985529→ | GCS Medical College, Hospital and Research Centre→ | Inclusion criteria: RT-PCR COVID-19 Test Positive patients will be included <br/ ><br>Moderate to Severe COVID Pneumonia patients will be included <br/ ><br>→ | Exclusion criteria: Patients with Active Tuberculosis, Past history of Tuberculosis, Other active suspected Viral/Fungal infection, Platelet count <50,000/ml and Absolute Pneutrophil Count <1000/ml will be excluded→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Role of Tocilizumab in COVID-19 PneumoniaTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027275 | 27 January 2021 | The study of occurrence , distribution and control measures of COVID-19 among police personnel during pandemic in Pune city , Maharashtra | An epidemiological study of COVID-19 among police personnel during pandemic in Pune city , Maharashtra | | NIL | 20-08-2020 | 20200820 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46386 | Not Recruiting | No | | | | 20-08-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Dr Ganesh Jagdale→ | | Department of community medicine B J Govt Medical college Near
Pune station Pune→ | drparandemalan@gmail.com→ | 9850131337→ | B.J. GOVT. MEDICAL COLLEGE & SASSOON GENERAL HOSPITAL PUNE→ | Inclusion criteria: All willing police personnel will be enrolled for KAP study towards covid-1 and all laboratory confirmed Covid-19 cases will be enrolled for epidemiological study after taking verbal informed consent.→ | Exclusion criteria: All laboratory confirmed Covid 19 cases other than police personnel in Pune city area.→ | | | Sociodemographic and some of the epidemiologic features of Covid-19 cases among police personnel. Also the knowledge, attitude and practices towards Covid-19 among police personnel. <br/ ><br> <br/ ><br>Timepoint: TILL 26TH JUNE 2020→ | | | | Yes | False | | |
| → | CTRI/2020/08/027281 | 27 January 2021 | Assessing the fear and worries associated with covid-19 in out-patient population of a hospital | Assessment of fear and anxiety due to covid-19 in the out-patient population of tertiary care hospital | | GCS medical college hospital and research centre | 20-08-2020 | 20200820 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46396 | Not Recruiting | No | | | | 31-08-2020 | 250 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Parth Shah→ | | GCS medical college hospital and research centre opp DRM office near chamunda bridge naroda road Ahmedabad → | shahparth1094@gmail.com→ | | GCS medical college hospital and research centre→ | Inclusion criteria: THOSE WHO ARE WILLING TO GIVE CONSENT FOR PARTICIPATION IN STUDY→ | Exclusion criteria: THOSE WHO ARE NOT WILLING TO GIVE CONSENT FOR PARTICIPATION IN STUDY→ | | | Fear and anxiety associated with covid-19 among the outpatient population will be assessedTimepoint: BASELINE DAY 0→ | | | | Yes | False | | |
| → | CTRI/2020/08/027282 | 27 January 2021 | Prophylactic Ivermectin in COVID 19 Contacts | Effectiveness of Ivermectin in preventing development of symptomatic Covid-19 among primary contacts of newly diagnosed Covid-19 positive patients at a tertiary care hospital in North India - an interventional study | | Department of Community Medicine | 20-08-2020 | 20200820 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46676 | Not Recruiting | No | | | | 31-08-2020 | 180 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded | Phase 3 | India→ | Dr Hariom Kumar Solanki→ | | Room no. 401
Department of Community Medicine
Government Institute of Medical Sciences
Greater Noida
UP → | saurabhsrivas@gmail.com→ | | Govt Institute of Medical Sciences→ | Inclusion criteria: All the family members of a newly diagnosed Covid-19 patient who are - living with the patient in the last 2 weeks, aged between 18 years and 60 years of age, asymptomatic on the day of diagnosis of the index case.→ | Exclusion criteria: The following will be excluded from the study: <br/ ><br>1. Pregnant or lactating women <br/ ><br>2. Those with any degree of ARI symptoms or fever. <br/ ><br>3. Person with known history of severe hypersensitivity reaction to previous exposure to Ivermectin. <br/ ><br>4. People with pre-existng severe medical conditions according to the judgement of <br/ ><br>the investigators→ | | Intervention1: Ivermectin 12mg or Ivermectin 36mg single dose orally once only: The study will have two intervention arms. <br><br>In the intervention Arm 1: 12mg oral Ivermectin will be given to the close family contacts fulfilling the inclusion- exclusion criteria for this study; of the newly diagnosed Covid-19 patient within 24 hours of diagnosis. The drug will be given orally and once only (under supervision). <br><br>In the intervention Arm 2: 36 mg oral Ivermectin will be given to the close family contacts fulfilling the inclusion- exclusion criteria for this study; of the newly diagnosed Covid-19 patient within 24 hours of diagnosis. The drug will be given orally and once only (under supervision).<br>Control Intervention1: Two Multivitamin tablets: In the control group - each participant will be given 2 (two) multivitamin tablets (available in the supply at the study institute). These tablets will be given orally, under-supervision and only once.<br>→ | Symptomatic Covid-19 among the study participantsTimepoint: Between 7 and 10 days of Ivermectin intake→ | | | | Yes | False | | |
| → | CTRI/2020/08/027284 | 27 January 2021 | A study to evaluate the efficacy and safety of Aceinavir combined with supportive Standard of Care (SoC) in hospitalized patients with moderate coronavirus disease (COVID-19) | A prospective, multicenter, randomized, open-label, parallel design study to evaluate efficacy and safety of Aceinavir combined with supportive Standard of Care (SoC) with moderate Coronavirus disease (COVID-19) in hospitalized patients | | Dyuthi Biosciences Private Limited | 20-08-2020 | 20200820 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46679 | Not Recruiting | No | | | | 28-08-2020 | 44 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Shashank Acharya→ | | Dyuthi Biosciences Pvt. Ltd, Department of Research and
Development, No 415/25/5,2nd Block, H.Nagar, Bangalore,
Karnataka, India, 560085 → | sruthi.nambiar@trialguna.com→ | 9663442072→ | TrialGuna→ | Inclusion criteria: Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF) <br/ ><br>1. Age 18-80 years (inclusive) at the time of signing ICF. <br/ ><br>2. SARS-CoV-2 positive report â?? rtPCR or Rapid Antigen <br/ ><br>3. Initial COVID-19 symptom onset within 4 days prior to Screening <br/ ><br>4. For female subjects: evidence of post-menopause, or for pre-menopause subjectâ??s negative pre-treatment serum or urine pregnancy test <br/ ><br>5. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment <br/ ><br>6. SpO2 â?¥ 93% on room air <br/ ><br>7. Not participating in any other interventional drug clinical studies before completion of the present study. <br/ ><br>→ | Exclusion criteria: Subjects meeting any of the following criteria must not be enrolled in the study: <br/ ><br>1. Severe or critical COVID-19 illness: RR â?¥26, HR â?¥100, SpO2 <93% on room air or requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 â?¥95%, systolic blood pressure < 110 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300 <br/ ><br>2. Inability to intake or tolerate oral medications. <br/ ><br>3. Known asthma or COPD <br/ ><br>4. Poorly controlled Diabetes <br/ ><br>5. Lobar or segmental consolidation on chest imaging or on clinical signs. <br/ ><br>6. Treatment with other drugs thought to possibly have activity against SARS-CoV-2 <br/ ><br>7. ALT or AST > 5 x upper limit of normal (ULN) <br/ ><br>8. Female subject is pregnant or breastfeeding <br/ ><br>9. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Aceinavir (1 gram uncoated tablet): Arm A would enroll 22 moderately symptomatic COVID-19 subjects treated with Aceinavir (Investigational Product) and Standard of Care (SoC). <br>Dose is 4 tablets thrice daily till end of clinical recovery or as per the discretion of clinical investigator<br>Control Intervention1: Standard of Care (SoC): Arm B would enroll 22 moderately symptomatic COVID-19 subjects treated with SoC.<br>The Standard of Care(SoC) will be as per the local hospital protocol and as per recommendations / guidelines by the respective authorities (Ministry of Health and Family Welfare, CDC and USFDA) whichever fits best at the time of initiation of this study. This will also be followed by the best supportive care guidelines recommended by the authorities (Ministry of Health and Family Welfare, CDC and USFDA).<br>→ | Time to Clinical recovery on a 7-point ordinal scale <br/ ><br>The scale is as follows: 0) No clinical or virological evidence of infection; 1) No limitation of activities 2) Limitation of activities 3) Hospitalized, no oxygen therapy 4) Oxygen by mask or nasal prongs 5)Non-invasive ventilation or high-flow oxygen 6) Intubation and mechanical ventilation 7) Ventilation + additional organ support â?? pressors, RRT, ECMO 8) Death <br/ ><br>Timepoint: At the end of the study (Time of clinical recovery)→ | | | | Yes | False | | |
| → | CTRI/2020/08/027285 | 27 January 2021 | Safety of convalescent plasma (CVP) drawn from mild symptomatic COVID-19 patients. | Study to assess and establish safety of convalescent plasma (CVP) drawn from mild symptomatic COVID-19 patients. - mCCP | | AIIMS | 20-08-2020 | 20200820 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45050 | Recruiting | No | | | | 21-08-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Diptiranjan Rout→ | | Dept. of Transfusion Medicine, Room No. 13, Academic Block, NCI-AIIMS, Badsa, Jhajjar → | drdiptiranjanrout@gmail.com→ | 08727804293→ | AIIMS→ | Inclusion criteria: a) Anyone aged >18 years and <65 years; <br/ ><br>b) Males; <br/ ><br>c) Body weight: >50 kg; <br/ ><br>d) Patients with complete seroconversion; <br/ ><br>e) Written informed consent to participate in the study. <br/ ><br>f) Confirmed previous SARS CoV-2 infection with mild symptomatology limited to: 1) cough, 2) fever, 3) myalgia, 4) sore throat, 5) chest pain or pressure, 6) congestion, 7) headache 8) diarrhoea, 9) nausea, and 10) loss of taste or smell.→ | Exclusion criteria: a) Anyone aged <18 years and >65 years; <br/ ><br>b) Females; <br/ ><br>c) Any comorbid conditions like Diabetes mellitus (uncontrolled), Hypertension (Uncontrolled), Asthma or any other respiratory conditions; <br/ ><br>d) Patients of COVID-19 with moderate and/ or severe symptomatology; <br/ ><br>e) Patients with no seroconversion; <br/ ><br>f) Patients with incomplete seroconversion; <br/ ><br>g) Failure to obtain Written informed consent; <br/ ><br>h) Known cases of any malignancy (Cancer COVID-19). <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To establish seroconversion in mild symptomatic COVID-19 patients and thence, to establish the safety of the convalescent plasma drawn from such patients for the therapeutic usage in other patients. <br/ ><br>Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027283 | 27 January 2021 | A clinical trial to evaluate the medicinal efficacy and safety of Ayurvedic kit in COVID-19 positive Patients. | EFFICACY AND SAFETY OF â??AYUR RAKSHA KITâ?? IN MILD COVID-19 PATIENTS AT A TERTIARY CARE HOSPITAL: AN OPEN-LABEL, RANDOMIZED CONTROL STUDY | | Dr VISHWA SANTHOSHA BHARATHI | 20-08-2020 | 20200820 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46591 | Not Recruiting | No | | | | 24-08-2020 | 30 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr BHAVYA DARSHINI M→ | | BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
FORT KR ROAD
DEPARTMENT OF COVID 19
BENGALURU BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE
FORT KR ROAD
DEPARTMENT OF COVID 19
BENGALURU→ | bmccrj@gmail.com→ | 9448292424→ | BANGALORE MEDICAL COLLEGE AND RESEARCH INSTITUTE→ | Inclusion criteria: 1. Patients willing to give written informed consent <br/ ><br>2. Patients of either sex aged between 18 and 60 years. <br/ ><br>3. Patients diagnosed with COVID-19 positive (confirmed by RT-PCR) <br/ ><br>Mild symptomatic patients (Patients with uncomplicated upper respiratory tract infection) such as: <br/ ><br>SpO2: â?¥94% in room air <br/ ><br>RR: â?¤ 24/m <br/ ><br>No evidence of hypoxemia or breathlessness <br/ ><br>→ | Exclusion criteria: 1.Patients who is not willing to give consent for the study. <br/ ><br>2.Patients who has uncontrolled comorbidities like Diabetes, Hypertension and heart diseases. <br/ ><br>3.Patients with pre-existing respiratory conditions, renal and liver diseases. <br/ ><br>4.Immunocompromised individuals/those on immunosuppressants. <br/ ><br>5.Female patients who are pregnant/ lactating or considering pregnancy. <br/ ><br>6.Psychiatric or emotional disturbance in patients which would limit ability of the patients to comply.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayur Raksha kit: Ayur Raksha Capsules 500 mg QID and Ayur Raksha Choorna 4 grams QID for 7 days<br>Control Intervention1: Standard treatment: Covid-19 positive patients receiving standard therapy for 7 days<br>→ | 1.Number of patients achieving Virological cure <br/ ><br>2.Time to achieve Virological cure <br/ ><br>Virological cure is defined as RT-PCR turning negativeTimepoint: Day 1 baseline assessment Day 3 Telephonic follow-up will be done for improvement in symptoms and Side-effects Day 7 Telephonic assessment with RT-PCR will be done <br/ ><br>Day 10 Telephonic assessment with Total count and differential count of WBCs, D-dimer, CRP, Derived Neutrophil to Lymphocyte Ratio: d-NLR will be done→ | | | | Yes | False | | |
| → | CTRI/2020/08/027301 | 27 January 2021 | Assessment of anxiety related to excessive internate search regarding covid-19 pandemic in medical students and para-medical staff. | Cyberchondria and health anxiety among medical students and para-medical staff during COVID-19 pandemic. | | GCS medical college hospital and research center | 21-08-2020 | 20200821 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46394 | Not Recruiting | No | | | | 26-08-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | KRISHNA DAVE→ | | GCS medical college hospital and research center opposite DRM office near chamunda bridge naroda road Ahmedabad → | krishna9857.kd5@gmail.com→ | 9722604373→ | GCS Medical college→ | Inclusion criteria: 1) THOSE WHO ARE WILLING TO GIVE CONSENT FOR PARTICIPATION. <br/ ><br>2)M.B.B.S STUDENTS OF All YEARS, RESIDENT DOCTORS AND PARA-MEDICAL STAFF OF GCSMCHRC <br/ ><br>→ | Exclusion criteria: 1)THOSE WHO ARE NOT WILLING TO GIVE CONSENT FOR PARTICIPATION. <br/ ><br>→ | | | 1) To evaluate the cyberchondria construct among the medical students and paramedical staff using Cyberchondria Severity Scale (CSS-15). <br/ ><br>2) To assess general mental health of medical students and paramedical staff. <br/ ><br>Timepoint: BASELINE DAY 0→ | | | | Yes | False | | |
| → | CTRI/2020/08/027316 | 27 January 2021 | The effect of Ayurvedic intervention (Ayurveda Raksha Kit) as a preventive measure in the Pandemic of COVID-19 - A community based study | A prospective open label controlled interventional study on the effect of Ayurvedic intervention (Ayurveda Raksha Kit) as a prophylactic measure in the Pandemic of COVID-19 - A community based study | | Central council for research in Ayurvedic sciences | 21-08-2020 | 20200821 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46680 | Not Recruiting | No | | | | 28-08-2020 | 200000 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | Dr Sunita mata→ | | Technical Section Room No. 121
Central Council for Research in Ayurvedic Sciences
No.61-65, Institutional Area, Opp. D Block, Janakpuri,
New Delhi - → | sunita.dr@rediffmail.com→ | | Central Council for Research in Ayurvedic Sciences→ | Inclusion criteria: a) Participants residents of the identified SC dominated area/colony/village where at least 1 confirmed case is already identified <br/ ><br>b) Above the age of 18 years & above <br/ ><br>c) Participants who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br>d) Willing to take study medication <br/ ><br>→ | Exclusion criteria: e) Known cases of Covid-19. <br/ ><br>f) Pregnant and Lactating females <br/ ><br>g) Known cases of uncontrolled Diabetes and Hypertension <br/ ><br>h) Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>i) Participants having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>j) Participants taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>k) Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>l) Participants having a history of allergy to any medicine that is part of the Ayurvedic intervention. <br/ ><br>→ | | Intervention1: Ayurvrda Raksha Kit and advised to follow Standard preventive measures of COVID-19 (liquid soap/soaps for hand wash and mask/masks will be provided): The Ayurveda Raksha Kit will be procured from IMPCL, a GMP certified Ayurveda Pharmaceutical Company under M/o AYUSH, Govt. of India.<br>Chyawanprash- 6 gm OD in the morning, <br>Ayush kwath-3 gm boiled in 150 ml of water filtered and consume once a day,<br>Samshamani Vati- Two tabs(250 mg each) twice a day with normal water,<br>Anu taila- one drop in each nostril two times a day<br>Duration of intervention: One month<br><br>Control Intervention1: Standard preventive measures of COVID-19: Advised to follow Standard preventive measures of COVID-19 (liquid soap/soaps for hand wash and mask/masks will be provided)<br><br><br>→ | Primary Outcome measures <br/ ><br>1) Comparative assessment of occurrence of COVID-19 infection in Clinically stable participants in community having at least 1 confirmed case already identified with control arm of Standard Prophylactic Care <br/ ><br> <br/ ><br>Timepoint: baseline, 15th day, 30th day, 45th day→ | | | | Yes | False | | |
| → | CTRI/2020/08/027299 | 27 January 2021 | A study to find out possible causes of mortality amongst the Covid-19 patients that are admitted in GCS Medical College, Ahmedabad | A retrospective study to find out clinical course and risk factors for mortality of inpatients with COVID-19 at GCS Medical College, Hospital and Research Centre, Ahmedabad | | Dr Rushi Patel | 21-08-2020 | 20200821 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46175 | Not Recruiting | No | | | | 31-08-2020 | 600 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Rushi Rashmikant Patel→ | | GCS Medical college, Hospital and Research centre
Opp DRM office
Near chamunda bridge
Naroda road
Ahmedabad → | rrpatel9@gmail.com→ | 07966048000→ | GCS Medical College, Hospital and Research Centre→ | Inclusion criteria: All COVID-19 patients admitted at GCS Medical College, Hospital & Research Centre During the April to June 2020→ | Exclusion criteria: Laboratory confirmed negative for COVID-19 by RT-PCR assay.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To determine most common presentation and symptomatology. <br/ ><br>To determine most common age group to be affected and if there is any sex predilection. <br/ ><br> <br/ ><br>Timepoint: 3 months <br/ ><br> <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/08/027286 | 27 January 2021 | Effectiveness of Siddha Medicines Kabasura Kudineer and Nilavembu Kudineer in the Management of Smptomatic COVID 19 patients | A Controlled Double Blinded RCT to Evaluate the
effectiveness of Siddha medicines, Kaba Sura Kudineer(KSK) &Nilavembu Kudineer(NVK) along with Standard Allopathy Treatment in the management of symptomatic COVID 19 patients
| | Government Institute of Medical Sceinces | 21-08-2020 | 20200821 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46511 | Recruiting | No | | | | 22-08-2020 | 120 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | Dr ANURAG SRIVASTAVA→ | | Government Institute of Medical Sceinces, Gautam Buddha Nagar,
Greater Noida.
Government Institute of Medical Sceinces, Gautam Buddha Nagar, → | dranurag23@gmail.com→ | 730384221→ | Government Institute of Medical Sceinces,→ | Inclusion criteria: 1. Laboratory Confirmed COVID â?? 19 with Mild and Moderate symptoms (as per ICMR Guidelines) with 2:1 Ratio in each group with proper representation of Age group/Sex. <br/ ><br>2. Aged 18-65 years <br/ ><br>3. Consenting to participate in the study and sign the informed consent <br/ ><br>→ | Exclusion criteria: 1. Patients with severe primary respiratory disease or other pathogenic microbial pneumonia <br/ ><br>2. Patient with Uncontrolled DM (â?¥ 350 mgs Fasting Sugar) SevereHT(180/120 mmHg as per JNC 8 Guidelines), Chronic BA(â?¥ 5 years Based on Clinical History), Renal Dysfunction (Known CKD â?¥ 5 years eGFR Stage â?¥ 3 as per NKA guidelines) <br/ ><br>3. Pregnant and Lactating mothers <br/ ><br>4. Patients with other systemic malignant diseases such as malignant tumors, mental illnesses, which the researchers consider unsuitable for participation in the study <br/ ><br>5. People who have history of allergic to Siddha medicine or intolerant to taking medication <br/ ><br>6. Patients participating in other COVID-19 clinical trials <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Kaba sura Kudineer: 60 ml twice a day- Morning and Night After food for 10 days<br>Intervention2: Nilavembu Kuidneer: 60 ml twice a day- Morning and Night After food for 10 days<br>Control Intervention1: Decaffeinated Tea: 60 ml twice a day- Morning and Night After food for 10 days<br>→ | 1.Reduction in Viral load of SARS-CoV-2 at the end of treatment <br/ ><br>2.Time taken to convert Patient from symptomatic to Asymptomatic based on Reduction in clinical symptoms like fever, cough and breathlessness <br/ ><br> <br/ ><br>3.Effect of drugs inflammatory markers (IL6,) at the end of treatment. <br/ ><br>4.Reduction in use of Intensive Supportive Care <br/ ><br>Timepoint: 10 Days→ | | | | Yes | False | | |
| → | CTRI/2020/08/027300 | 27 January 2021 | Efficacy and feasibility of Teleneurorehabilitation in Persons with Parkinsons Disease | TelePark: Tele-Neurorehabilitation versus In-person Rehabilitation in person with Parkinsons Disease in India during COVID-19: A Randomised Trial - TelePark | | Investigatorinitiated trial Prof RK Dhamija | 21-08-2020 | 20200821 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44285 | Not Recruiting | No | | | | 01-09-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Rajinder K Dhamija→ | | Department of Neurology
Lady Hardinge Medical College
Connaught Place
110001
New Delhi → | dhamijark@gov.in→ | 011-2340-8279→ | Lady Hardinge Medical College and SSK Hospital→ | Inclusion criteria: 1. A clinical diagnosis of idiopathic PD with a disease severity rating of stage 1 to 2.5 on Hoehn and Yahr scale (Supplement 2) within the past two months <br/ ><br>2. Age above 18 years <br/ ><br>3. Participants who can give written consent <br/ ><br>4. Not on any formal rehabilitation <br/ ><br>5. Home access to video calling facility <br/ ><br>→ | Exclusion criteria: 1. Current participation in any other trial or formal rehabilitation program <br/ ><br>2. Cognitive impairment as indicated by a Mini Mental Status Examination (MMSE) score of below 23 <br/ ><br>3. Other debilitating conditions eg. Hearing or visual impairment that can impede full participation in the study <br/ ><br>4. Inability to perform rehabilitation therapy for any reason <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: G20- Parkinsons disease
→ | Intervention1: Tele-Neurorehabilitation: Participants in this group will attend a 12-week structured rehabilitation program. Baseline assessment and informed consent will be obtained in person. They will undergo supervised rehabilitation program for duration of 30 minutes in the department of Physical Medicine & Rehabilitation (PMR), LHMC & Associated Hospitals on day 1 followed by supervised tele â?? rehabilitation once a week for the first four weeks & once every two weeks for 8 weeks. The participant will have to perform therapeutic exercises at home for at least five days per week (including the training session) and either the patient or their caretaker will maintain a video log and Parkinsonâ??s disease diary regarding details of home-based program performed and adherence to schedule.<br>Control Intervention1: In-person rehabilitation: Individuals assigned to this group will participate in supervised rehabilitation program for duration of 30 minutes in department of PMR initially once in a week for the first 4 weeks and then once every 2 weeks for next 8 weeks. <br>Similar to the intervention group, each participant or their caretaker will have to maintain a video log and Parkinsonâ??s diary documenting adherence and duration of therapeutic exercises done at home.<br>→ | 1. Motor symptoms- Change in MDS-UPDRS III score at baseline and 12 weeks <br/ ><br>Movement Disorder Society-Unified Parkinsonâ??s Disease Rating Scale- Part III Motor Examination (MDS-UPDRS-III) is an 18-item, assessor-rated instrument assessing severity of PD motor symptoms. Each item is scored â??0â?? to â??4â?? on a categorical scale, in which â??0â?? indicates no impairment and â??4â?? represent severe impairment. The total score is 132. Higher scores indicate more motor disabilities. <br/ ><br>Timepoint: 0 (baseline) and 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/08/027324 | 27 January 2021 | Study to assess the usefulness, effectiveness and feasibility for future use of the consultations done using telephone/whatsapp in rheumatic diseases during CoVID-19 pandemic | Teleconsultations for rheumatic diseases during CoVID-19 pandemic:
Usefulness, Cost-effectiveness, patient response and prospects for future practice | | Not Applicable | 23-08-2020 | 20200823 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46339 | Not Recruiting | No | | | | 01-09-2020 | 5000 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ranjan Gupta→ | | Dept. of Rheumatology, AIIMS, New Delhi → | dr.guptaranjan@gmail.com→ | 9868396940→ | AIIMS, New Delhi→ | Inclusion criteria: Consenting patients <br/ ><br>Patients must have had at least 2 prior physical visits to the department <br/ ><br>COnsents to give feedback about their tele-consultations <br/ ><br>Has the facility for video-calling applications like WhatsApp→ | Exclusion criteria: Non-consenting patients→ | Health Condition 1: M368- Systemic disorders of connective tissue in other diseases classified elsewhere
→ | Intervention1: Tele-consultation using telephone and WhatsApp: In the wake of COVID-19 pandemic, patients would be given tele-consultations using telephone and video calling using WhatsApp which is the new intervention in the patient care.<br>Control Intervention1: None: No comparator. Its a single arm study.<br>→ | To weigh the usefulness of tele-consultations in rheumatic diseases patients in assessing patientsâ?? condition and addressing their complaints using Numeric rating Score (NRS)Timepoint: Single time point after the tele-consultation→ | | | | Yes | False | | |
| → | CTRI/2020/08/027323 | 27 January 2021 | A survey to collect vital parameters and symptoms of participants at risk of COVID19 | Prospective Observational Study to Monitor Participants at risk of COVID 19 - POMPCO | | INNOWEAR TECHNOLOGIES PRIVATE LIMITED | 23-08-2020 | 20200823 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46086 | Not Recruiting | No | | | | 26-08-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Megha Patel→ | | Rhythm Heart Institute
Near Siddharth Bunglows
Sama-Savli Road → | kailashhospital@yahoo.com→ | 91-265-2960601→ | Kailash Hospital→ | Inclusion criteria: Participants at risk of COVID19 <br/ ><br>1.Household or Close contacts of COVID-19 cases <br/ ><br>2.Staff working in COVID care centres <br/ ><br>3.COVID-19 Hotspots <br/ ><br>→ | Exclusion criteria: 1 Age less than 18 years and over 80 years <br/ ><br>2 Previous COVID-19 treated case <br/ ><br>3 Terminally ill patients <br/ ><br>4 Patients with any debilitating disease at discretion of Principal investigator especially severe COPD, severe IHD, Malignancy etc <br/ ><br>5 Patients on medicines affecting heart rate like betablockers <br/ ><br>6 Immunocompromised subjects <br/ ><br>7 Pregnant subjects <br/ ><br>8 Unable to use Pulse oximeter and thermometer <br/ ><br>→ | | | Early detection of COVID-19 <br/ ><br>Timepoint: At Baseline <br/ ><br>At 2 weeks <br/ ><br>At 3 weeks <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/08/027345 | 27 January 2021 | Re-purposing of Anti HCV drugs for the treatment of COVID-19 diseasr | Selection and Prioritization of Antiviral Drugs used for Hepatitis C Virus (HCV) and evaluation of their efficacy and safety in COVID- 19 Patients: A Rational target- based Pilot Repurposing Trial - SPARTACOS-19 trial | | Pt B D Sharma post graduate institute of medical sciences | 24-08-2020 | 20200824 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45932 | Not Recruiting | No | | | | 31-08-2020 | 175 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 3 | India→ | Dhruva Chaudhry→ | | Head of Department
Dept of Pul and Crit Care Medicine
Pt B D Sharma PGIMS Rohtak → | dhruvachaudhry@yahoo.co.in→ | | Pt B D Sharma PGIMS Rohtak→ | Inclusion criteria: Adult patients with COVID-19 aged 18 years and above <br/ ><br>RT-PCR positive for SARS-CoV-2 <br/ ><br>Willing to give written informed consent <br/ ><br>→ | Exclusion criteria: Pregnancy or breast feeding <br/ ><br>Hepatic cirrhosis <br/ ><br>Alanine aminotransferase or aspartate aminotransferase more than five times the upper limit of normal <br/ ><br>Known severe renal impairment (estimated glomerular filtration rate <30 mL/min per 1·73 m2) or receipt of continuous renal replacement therapy, haemodialysis, or peritoneal dialysis <br/ ><br>Enrolment into an investigational treatment study for COVID-19 in the 30 days before screening <br/ ><br>Patients of child-bearing age (men and women) not agreeing to take effective contraceptive measures (including hormonal contraception, barrier methods, or abstinence) during the study period and for at least 7 days after the last study drug administration <br/ ><br>Any known hypersensitivity to the study drugs <br/ ><br>Any patient belonging to Severe class of COVID19 disease as per GOI guidelines (MoHFW)→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Daclatasvir and Sofosbuvir: FDC of Daclatasvir (60mg) and Sofosbuvir (400mg) <br>To be given once a day for 14 days<br>Intervention2: Ledipasvir and Sofosbuvir: FDC of Ledipasvir (90mg) and Sofosbuvir (400mg) to be given once a day for 14 days<br>Control Intervention1: Standard of care: standard of care<br>→ | To assess the antiviral efficacy of the investigational products: COVID19 negativity after 7 days of treatmentTimepoint: Baseline, 7 days, 14 days and 28 days→ | | | | Yes | False | | |
| → | CTRI/2020/08/027346 | 27 January 2021 | To assess the clinical efficacy of Ayurvedic interventions in managing asymptomatic to mild cases of COVID-19 | A prospective randomized controlled clinical trial to evaluate the efficacy and safety of Ayurvedic interventions in the management of COVID-19(Asymptomatic to moderate cases) | | Shri Dhanwantry ayurevdic college and hospital | 24-08-2020 | 20200824 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46229 | Not Recruiting | No | | | | 25-08-2020 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Shikha Chaudhary→ | | Department of Research, room no 110, shri dhanwantry ayurvedic college and hospital 77 chandi path sector 46 B Chandigarh → | drshikha08@icloud.com→ | 9205109463→ | shri dhanwantry ayurvedic college and hospital→ | Inclusion criteria: Asymptomatic to moderate cases registered in the Hospital, above 18 years of age of either gender, with COVID 2019 (Confirmed by Antigen test/ RT-PCR) quarantined at our hospital. <br/ ><br>2. Participants who can take medicines orally <br/ ><br>3. Patients willing to provide signed informed consent→ | Exclusion criteria: 1. Patients suffering from severe COVID-19 Disease as judged by a physician <br/ ><br>2. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study <br/ ><br>3. Patients who are likely to worsen or planed ICU admission or ventilator support due to any reason <br/ ><br>4. Pregnancy and lactation <br/ ><br>5. Participation in a drug interventional clinical drug trial of any nature in the three month period preceding onset of COVID-19 <br/ ><br>6. Participation in any other clinical trial of an experimental agent treatment for COVID-19 <br/ ><br>7. Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind. <br/ ><br>8. Physician decision that involvement in the study is not in the patient´s best interest. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayush-64, Agasthya Haritaki, Anu taila Nasal drops: AYUSH-64 500 mg Tablets Oral<br>Twice a day 2 hrs after food<br>Lukewarm water for 10 days<br>Agasthya Haritaki Avleha 5 gm<br><br>Oral<br>Twice a day 2 hrs before food Lukewarm water for 10 days<br>Anu taila 2 drops<br>Oil Nasal instillation<br>Twice a day for 10 days<br>Intervention2: Broncho-T Granules: 50 ml<br>Decoction Oral Thrice a day 1 hrs before food Lukewarm water<br>for 10 days<br>Control Intervention1: Standard conventional treatment as per ICMR guidelines: Symptomatic care<br>→ | 1. Mean time for clinical recoveryTimepoint: 1. 5th and 10th day→ | | | | Yes | False | | |
| → | CTRI/2020/08/027359 | 27 January 2021 | A study regarding knowledge, attitude and practice about immunity boosting measures for prevention of COVID-19 infection among healthcare workers at tertiary care hospital | An interventional study regarding knowledge, attitude and practice about immunity boosting measures as per Ministry of AYUSH among healthcare workers at Tertiary care centre during COVID 19 pandemicâ?? | | Bhaikaka University | 24-08-2020 | 20200824 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46829 | Not Recruiting | No | | | | 15-09-2020 | 300 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Manisha Gohel→ | | Community Medicine Department,Pramukhswami Medical College,Bhaikaka University,Gokal Nagar ,Karamsad,Dist:Anand
GUJARAT,INDIA Community Medicine Department,Pramukhswami Medical College,Bhaikaka University,Gokal Nagar ,Karamsad,Dist:Anand
GUJARAT,INDIA→ | manishakg74@gmail.com→ | 9824610142→ | Pramukhswami Medical College→ | Inclusion criteria: Inclusion criteria will be health care workers who are working at Tertiary Care Centre and attending the sessions of Immunity Boosting Measures.→ | Exclusion criteria: Nil→ | | Intervention1: Educational Intervention: Session of Immunity Boosting measures for self-care will be conducted for health care workers once a week at tertiary care centre by Bhaikaka University. Contents of session will be immunity booster measures for self-care, based on recommendations by Ministry of AYUSH.Session will include PowerPoint presentation (interactive session) & demonstration with teaching of immunity booster measures like Prananyamas; Anulom-Vilom, Bhramri &Ujjayi. Session will also include demonstration of Yoga cleansing techniques like Kapalbhati and Jalneti.Semi-structure questionnaire will be used to conduct pre & post- test. Participants will be contacted after three months of session again to know the measures implemented by them to boost self-immunity.<br>Intervention2: Single arm Education Interventional trial: Session of Immunity Boosting measures for self-care will be conducted for health care workers once a week at tertiary care centre. Contents of session will be immunity boosting measures for self-care, based on recommendations by Ministry of AYUSH. Session will include powerPoint presentation (interactive session) & demonstration with teaching of immunity booster measures like prananyamas; anulom-Vilom, bhramri & ujjayi. Session will also include demonstration of Yoga cleansing techniques like Kapalbhati and Jalneti.Semi-structure questionnaire will be used to conduct pre & post- test. Participants will be contacted after three months of session again to know the measures implemented by them to boost self-immunity.<br>Control Intervention1: Not applicable: Not applicable as single arm education interventional trial<br>→ | Health workers will sensitize about immunity booster measures and adopt these measures as part of their healthy living in day to day basisTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027396 | 27 January 2021 | Mental health of pregnant women Covid-19 pandemic | Assessment of psychological impact of Covid-19 pandemic in pregnant women visiting tertiary care facility: A cross-sectional study | | AIIMS New Delhi | 26-08-2020 | 20200826 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46853 | Not Recruiting | No | | | | 03-09-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Vidushi Kulshrestha→ | | 3082-A, Teaching Block, Dept. of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi → | drvidushi.kul@gmail.com→ | 9891910880→ | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: Pregnant women visiting antenatal clinic or emergency antenatal services at AIIMS, New Delhi and consenting to participate in the study <br/ ><br>→ | Exclusion criteria: - Those not willing to participate <br/ ><br>- Sick/hemodynamically unstable women <br/ ><br>→ | Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium
→ | Intervention1: This is a cross sectional study: Subjects will be assessed on following instruments: <br>- Semi-structured questionnaire<br>- Couple satisfaction Index (CSI-4)<br>- Edinburgh Postnatal Depression Scale <br>- DASS-21 Scale<br>- PHQ-SADS Scale<br>- Brief COPE<br>Intervention2: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Psychological assessmentTimepoint: At Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/08/027394 | 27 January 2021 | Assessment of response of ivermectin on virological clearance in COVID 19 patients | Assessment of response of ivermectin on virological clearance in COVID 19: single centre, open labelled, randomised controlled trial | | not applicable | 26-08-2020 | 20200826 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46873 | Not Recruiting | No | | | | 02-09-2020 | 56 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | ROMIT SAXENA→ | | Department of Pediatrics, Maulana Azad Medical College, Bahadur Shah Zafar Road , New Delhi Bahadur Shah Zafar Marg, New Delhi-110002→ | drromit@gmail.com→ | | Department of Pediatrics, Maulana Azad Medical College→ | Inclusion criteria: 1.Patients admitted with COVID 19 , positive report, or are detected as positive after admission <br/ ><br>2. Present within 5 days of symptom onset <br/ ><br>3.The patient must be between the ages >5 years and 15 Kg, until 65 years of age <br/ ><br>4.Women in child bearing age(14-50 years) within 14 days of LMP only <br/ ><br>5.Mild-moderate symptoms at presentation as per Ministry of Family welfare, Government of India definitions <br/ ><br>→ | Exclusion criteria: 1. Known history of ivermectin allergy <br/ ><br>2. Hypersensitivity to any component of ivermectin <br/ ><br>3. Refusal of consent (Appendix 5 and 6). <br/ ><br>4. Co-morbidities e.g. Acute or chronic renal disease , History of coronary disease , pregnancy, History of cerebrovascular disease and malignancy <br/ ><br>5. Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Concomitant use of critical CYP3A4 substrate drugs such as warfarin. <br/ ><br>6.Prior use of ivermectin in last 15 days <br/ ><br>→ | Health Condition 1: A00-B99- Certain infectious and parasitic diseases
→ | Intervention1: administration of drug ivermectin for patients of mild or moderate COVID and assess response on virological clearance: administration of drug ivermectin for patients of mild or moderate COVID and assess response on virological clearance . The drug will be administered as a single dose at dose of 0.2 mg/kg as per institutional protocols. It will not be repeated.<br>Control Intervention1: no ivermectin administration , rest all patients, will receive treatment as per departmental protocol, which may include, vitamin C, Zinc, antipyretic, ranitidine/omeprazole/chloroquine , azithromycin etc. The only exception is the use of ivermectin, which will be used in the study group and not in the control group: no ivermectin administration , rest all patients, will receive treatment as per departmental protocol, which may include, vitamin C, Zinc, antipyretic, ranitidine/omeprazole/chloroquine , azithromycin etc. The only exception is the use of ivermectin, which will be used in the study group and not in the control group<br>→ | PRIMARY OBJECTIVE <br/ ><br>To assess the Efficacy of single dose of Ivermectin, given within first 5 days of symptom onset, as assessed by RT PCR for SARS CoV 2, at 3rd and 7th day after start of treatmentTimepoint: At Admission, 3rd and 7th Day after start of treatment <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/08/027403 | 27 January 2021 | A retrospective assessment of risk factors for COVID- 19 in health care workers | Assessment of risk factors for corona virus disease 2019 (COVID-19) in health care workes: a retrospective case control study | | Maulana Azad Medical College and associated Lok Nayak Hospital | 26-08-2020 | 20200826 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46923 | Not Recruiting | No | | | | 07-09-2020 | 90 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrSukhyanti Kerai→ | | Department of Anaesthesiology and Intensive Care
B.L. Taneja Block
Maulana Azad Medical College
Bahadur Shah Zafar Marg Bahadur Shah Zafar Marg, New Delhi 110002→ | drsukhi25@gmail.com→ | 9968527122→ | Maulana Azad Medical College→ | Inclusion criteria: A case is defined as a health worker exposed in a health care setting to a COVID-19 patient in the 14 days prior to the health workerâ??s positive RT-PCR test for COVID-19 irrespective of clinical signs and symptoms. <br/ ><br>A control is defined as a health worker exposed in a health care setting to a COVID-19 patient in the 14 days prior to recruitment; and who is not serologically tested positive.→ | Exclusion criteria: A case would be excluded if he/she is having a confirmed COVID-19 case among their close contacts, including in their household, within the previous 14 days (with the exception of the COVID-19 patient(s) to which they were exposed) or when he/she is not involved in direct patient care→ | | | factors responsible for COVID-19 infection in health care workersTimepoint: 20 Weeks→ | | | | Yes | False | | |
| → | CTRI/2020/08/027397 | 27 January 2021 | Role of Siddha medicine in the management of Covid-19 positive patients | â??An Open Clinical Trial to Evaluate the Safety & Efficacy of Siddha Sastric Medicines â?? Fixed Regimen in COVID-19 Positive asymptomatic, mild or moderate cases with reference to the Siddha guidelines of COVID-19 management, Ministry of AYUSH, Govt. of India at TPEC COVID-19 CARE Centre , Vellore ,Tamilnaduâ?? | | MR SHANMUGASUNDARAM IAS | 26-08-2020 | 20200826 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46165 | Recruiting | No | | | | 03-09-2020 | 20 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | DRSTHILLAIVANAN→ | | GOVT HOSPITAL, PERNAMBUT ANNA HOSPITAL CAMPUS ARUMBAKKAM CHENNAI→ | drthillai.mdsiddha@gmail.com→ | 8056040768→ | DEPARTMENT OF INDIAN MEDICINE AND HOMEOPATHY→ | Inclusion criteria: S.No Parameter <br/ ><br>1. Adult Male/Female subjects above the age of 18 years <br/ ><br>2. COVID -19 Positive as determined by RT-PCR <br/ ><br>3. Willing to provide written/digital informed consent. <br/ ><br>4. COVID - 19 Positive with no clinical signs <br/ ><br>5. COVID - 19 Positive with mild symptoms â?? Sneezing, Cough, Sore Throat, Throat Pain, Malaise, Tiredness, Fever, loss of smell, loss of taste <br/ ><br>6. COVID - 19 Positive with moderate symptoms â?? Fever with cough, breathlessness but respiratory rate <24 per minute and Oxygen saturation > 95% at rest <br/ ><br>→ | Exclusion criteria: S. No Parameter <br/ ><br>1. Pregnant and Lactating females <br/ ><br>2. COVID - 19 Positive with Severe symptoms â?? Respiratory distress ( >24 breath per minute), Oxygen saturation < 95% at rest, Respiratory failure, Need of Mechanical Ventilation, Septic shock, Non respiratory organ failure <br/ ><br>3. Chronic Renal Failure requiring dialysis (eGFR < 30) <br/ ><br>4. Known cases of uncontrolled Diabetes ( >9% HbA1c) <br/ ><br>5. Known cases of stage 3 Hypertension ( > 160/100 mmHg) <br/ ><br>6. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>7. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>8. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>9. Subjects who are participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>10. Subjects with bleeding disorders and severe anemia (Hb <7 g/dL) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: KAPA SURA KUDINEER: 60 ML TWICE DAILY for one week<br>Intervention2: AMUKKARA CHOORANAM TABLET: 2 TABLET THRICE DAILY for one week<br>Intervention3: THALISATHY VADAGAM: 2 TABLET THRICE DAILY CHEWABLE for one week<br>Intervention4: BRAMANANDHA BAIRAVAM TABLET: 1 OR 2 PILLS TWICE DAILY FOR ONE WEEK<br>Intervention5: ADATHODAI MANAPAGU: 10 ML TWICE DAILY FOR ONE WEEK<br>Control Intervention1: nil: nil<br>→ | â?¢ Reduction in Viral load of SARS-CoV-2 at the end of treatment <br/ ><br>â?¢ Reduction in clinical symptoms like fever, cough and breathlessness <br/ ><br>(1. Fever: â?¤36.6°C or -axilla, â?¤37.2 °C oral or â?¤37.8°C rectal or tympanic ; <br/ ><br>(2. Respiratory rate - â?¤24/minute on room air; <br/ ><br>(3. Cough - mild or absent on a patient reported scale (cough symptoms score â?¤ 2 points) <br/ ><br>Timepoint: ONE WEEK→ | | | | Yes | False | | |
| → | CTRI/2020/08/027407 | 27 January 2021 | COVID-19 with Hypertension is responsible for death of patients. | A study of incidence of mortality in patients of COVID-19 with hypertension. | | GCS Hospital Medical College and Research Centre | 26-08-2020 | 20200826 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46707 | Not Recruiting | No | | | | 31-08-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Mahipalsinh Raol→ | | Department of General Medicine, GCS Hospital, Medical College and Research Centre, opposite DRM Office, near Chamunda Bridge, Naroda Road, Ahmedabad → | mahipalraol9819995@gmail.com→ | 9428914856→ | GCS HOSPITAL, MEDICAL COLLEGE AND RESEARCH CENTRE→ | Inclusion criteria: Covid-19 Positive and Hypertensive Patients Admitted in GCSMCH&RC→ | Exclusion criteria: Covid-19 Negative Patients. <br/ ><br>Covid-19 Positive Patients but not a Known Case or Newly Detected Hypertension→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: I10- Essential (primary) hypertension
→ | | Relation between Covid-19 with Hypertension for Cause OF MortalityTimepoint: at Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/08/027395 | 27 January 2021 | Study of Radiological Imaging in COVID Patients | Radiological imaging in assessing prognosis of hospitalised COVID-19 patients | | Dr Swathy Moorthy | 26-08-2020 | 20200826 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46716 | Not Recruiting | No | | | | 01-09-2020 | 1000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Swathy Moorthy→ | | Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai → | drswathymoorthy@sriramachandra.edu.in→ | 9444016401→ | Sri Ramachandra University→ | Inclusion criteria: all the hospitalised COVID-19 patients above 18 years of age confirmed with Rt-PCR in nasal and pharyngeal swab specimens.→ | Exclusion criteria: patients under age of 18 years and those with other common bacteria or viruses associated with community acquired pneumonia→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: nil: not applicable<br>Control Intervention1: nil: not applicable<br>→ | Assess the Severity Score of Radiological Imaging in comparison to Clinical conditionTimepoint: at baseline→ | | | | Yes | False | | |
| → | CTRI/2020/08/027393 | 27 January 2021 | Physiotherapy Practices for patients with COVID-19- A National Survey | Physiotherapy Practices for patients with COVID-19- A National Survey | | Narasimman Swamiathan | 26-08-2020 | 20200826 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46249 | Not Recruiting | No | | | | 28-08-2020 | 250 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Narasimman Swaminathan→ | | Faculty of Allied Health Sciences, 1st Floor, University Building
Sri Ramachandra Institute of Higher Education and Research
Chennai → | narasimmansnathan@sriramachandra.edu.in→ | 9962455509→ | Sri Ramachandra Institute of Higher Education and Research→ | Inclusion criteria: Physiotherapists involved in COVID care→ | Exclusion criteria: Physiotherapist not involved in COVID care→ | | | Therapists perception and experience measured using questionnaireTimepoint: Once - 0 month→ | | | | Yes | False | | |
| → | CTRI/2020/08/027420 | 27 January 2021 | A Survey to Assess the Impact of the COVID-19 Pandemic and Resultant Lockdown Measures on Ongoing Clinical Trials in India | A Survey to Assess the Impact of the COVID-19 Pandemic and Resultant Lockdown Measures on Ongoing Clinical Trials in India | | Jayanti Gupta | 27-08-2020 | 20200827 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46472 | Not Recruiting | No | | | | 06-09-2020 | 130 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rakesh Dadhania→ | | A3, 402 Iscon Flower, Nr. Lal GEBI Ashram, Thatej, Ghuma, Daskroi, Ahmedabad → | jayantigupta@nishkash.com→ | | NishKash Consulting→ | Inclusion criteria: Principal investigators and site research staff of ongoing clinical trials <br/ ><br>Ethics Committee members of sites with ongoing clinical trials→ | Exclusion criteria: Not applicable→ | | | Responses to study questionnaires by PI/site research staffTimepoint: baseline→ | | 30/09/2020 | | Yes | False | | |
| → | CTRI/2020/08/027418 | 27 January 2021 | Offline versus online presentation: Benefits & Challenges during Covid pandemic . | Offline versus online presentation: Evaluation of the tradeoff between Efficacy & Challenges of the tectonic shift in the face of Covid pandemic . | | Manipal Academy of Higher Education | 27-08-2020 | 20200827 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46745 | Not Recruiting | No | | | | 15-09-2020 | 225 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Vijetha Shenoy Belle→ | | Department of BiochemistryKasturba Medical College Madhav Nagar → | vijetha.shenoy@manipal.edu→ | 09844667820→ | MD Biochemistry, KMC Manipal, Manipal Academy of Higher Education→ | Inclusion criteria: Study subjects in the age group of 18 and above of both gender with following qualification. <br/ ><br>a. Technicians working at clinical biochemistry lab <br/ ><br>b. PG students of clinical and non-clinical departments <br/ ><br>c. Faculty: clinical and non-clinical departments→ | Exclusion criteria: those who do not meet the inclusion criteria (for example, undergraduate students, administrative and office staff) will be excluded from the study.→ | | Intervention1: Nil: Nil<br>→ | To assess the usefulness, associations between the prominent groups. We will ascertain the challenges and positive aspects of the two modes of teaching-learning.Timepoint: Once (at the end of the study period that is 3 months)→ | | 10/11/2020 | | Yes | False | | |
| → | CTRI/2020/08/027419 | 27 January 2021 | Realtion of Catalytic iron and Hepcidin with Poor Outcomes in COVID-19 patients | Catalytic iron and hepcidin in patients with COVID-19 and their association with adverse outcomes | | Muljibhai Patel Society for Research in NephroUrology | 27-08-2020 | 20200827 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46503 | Not Recruiting | No | | | | 07-09-2020 | 49 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Vipul Chakurkar→ | | Renal Unit, Department of Medicine, KEM Hospital, Sardar Moodliar Road, Rasta Peth, Pune → | chakurkarvipul@gmail.com→ | 9403207328→ | KEM Hospital, Pune→ | Inclusion criteria: 1.Non-seriously ill COVID-19 patients(WHO1 to 4) <br/ ><br>2.Seriously ill COVID-19 positive patients (WHO 5 to 7) <br/ ><br>3.Patients with respiratory tract illness, who were initially suspected to have COVID-19, but test negative by RT-PCR test for COVID-19. <br/ ><br>→ | Exclusion criteria: Patients with previously known chronic kidney disease, stage 3 above.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Composite of acute kidney injury (AKI) requiring dialysis, need for mechanical ventilation and deathTimepoint: 1 month→ | | 24/09/2020 | | Yes | False | | |
| → | CTRI/2020/08/027435 | 27 January 2021 | COVID-19 severity in Elderly people aged more than 60years | Hospitalization outcomes among elderly with SARS-CoV-2 infection - a single centre restrospective study in India | | Dr Viswanathan P | 27-08-2020 | 20200827 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46530 | Not Recruiting | No | | | | 30-08-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Viswanathan P→ | | Department of general medicine,
Sri ramachandra medical college and research institute,
Porur,
Chennai. → | viswa.smc@gmail.com→ | 9789907448→ | SRIHER→ | Inclusion criteria: All patients aged 60years and above with confirmed diagnosis of COVID-19 ( diagnosed by RTPCR Nasopharyngeal swab / oropharyngeal swab / ET aspirate) admitted in site of study→ | Exclusion criteria: All patients less than 60 years of age <br/ ><br> <br/ ><br>→ | Health Condition 1: A00-B99- Certain infectious and parasitic diseases
→ | Control Intervention1: NIL: NIL<br>Control Intervention2: NIL: NIL<br>→ | 1.Severity of clinical presentation of SARS-CoV-2 infection among elderly <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/08/027458 | 27 January 2021 | laboratory predictors and covid | Single centre retrospective study of laboratory parameters including inflammatory markers and its correlation with the various categories of patients admitted with SARS CoV-2 infection. | | Dr Vaasanthi | 28-08-2020 | 20200828 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46665 | Not Recruiting | No | | | | 31-08-2020 | 850 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Vaasanthi→ | |
Department of general medicine, Sri Ramachandra medical college and research institute,Porur, Chennai.
Tamil nadu
600116
→ | vaasanthi_r@yahoo.co.in→ | 9597062801→ | Sri Ramachandra Institute of Higher Education and Research ( SRIHER)→ | Inclusion criteria: All patients aged 18years and above with confirmed diagnosis of COVID-19 ( diagnosed by RTPCR Nasopharyngeal swab /oropharyngeal swab / ET aspirate) admitted in site of study→ | Exclusion criteria: age less than 18years→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1 To correlate inflammatory markers and severity of SARS CoV 2 infection. <br/ ><br>To correlate D dimer with severity of SARS CoV 2 infection and clinical outcomes.Timepoint: Baseline at the time of admission and during discharge if applicable→ | | | | Yes | False | | |
| → | CTRI/2020/08/027460 | 27 January 2021 | Oxygen requirement in COVID patients. | Study on oxygen requirement and its correlation with inflammatory
biomarkers and radiological findings in SARS CoV2 infection. - a single centre retrospective
study from India. | | Priyadarshini Varadaraj | 28-08-2020 | 20200828 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46545 | Not Recruiting | No | | | | 31-08-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Priyadarshini Varadaraj→ | | Department of General Medicine,Sri Ramachandra University, Porur, Chennai, Tamil Nadu → | priyavaradaraj@gmail.com→ | 9840867899→ | Sri Ramachandra University→ | Inclusion criteria: All confirmed cases of SARS- Cov-2 of > 18 years of age which will be classified for severity as <br/ ><br>per ministry of health guidelines, Government of India.→ | Exclusion criteria: 1. <18 years of age <br/ ><br>2. Patients who expired within 24 hours of hospitalization→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | 1.To study the oxygen requirement in moderate and severely ill patients and <br/ ><br>the duration of oxygen therapy needed. <br/ ><br>2. To assess the mode of oxygen delivery and its efficacy in correcting <br/ ><br>hypoxia.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027459 | 27 January 2021 | To study about the outcome of COVID-19 on Diabetes patients | Hospitalization outcomes of SARS-COV2 infection among patients with diabetes mellitus- a single centre retrospective study from India. | | Dr Aiswarya M Nair | 28-08-2020 | 20200828 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46552 | Not Recruiting | No | | | | 01-09-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DR Aiswarya M Nair→ | | Department of Medicine,Sri Ramachandra Institute of Higher Education and Research (SRIHER, Porur,
Chennai → | docaishnair@gmail.com→ | 9566202902→ | Sri Ramachandra Institute of Higher Education and Research (SRIHER)→ | Inclusion criteria: All patients aged 18 yrs and above with confirmed diagnosis of COVID-19 and diabetes admitted in site of study→ | Exclusion criteria: All patients aged less than 18 years <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | Disease severity among hospitalized diabetic patientsTimepoint: 30 days→ | | | | Yes | False | | |
| → | CTRI/2020/08/027465 | 27 January 2021 | Nasal Wash and Gargle to Mitigate COVID-19 | Impact of Nasopharyngeal wash on Virion Load in COVID-19 Patients | | Health Family Welfare Department Government of West Bengal | 29-08-2020 | 20200829 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45634 | Not Recruiting | No | | | | 04-09-2020 | 70 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 1/ Phase 2 | India→ | UDAY SANKAR CHATTERJEE→ | | 241, Deshopran Shasmal Road, Tollygunge, Kolkata 4, Gorky Terrace, Kolkata - 700017
Pediatric Surgery.
Room No-608→ | udaysankarchatterjee@yahoo.com→ | 9831017686→ | M.R. Bangur Hospital→ | Inclusion criteria: Positive Patients of COVID-19→ | Exclusion criteria: Inability to perform nasopharyngeal saline wash→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nasopharyngeal saline wash: Study group will be treated with Nasopharyngeal Saline wash along with Standard treatment for COVID 19 as follows.<br> 1. Nasopharyngeal Wash with normal saline and pharyngeal gargle with antimicrobial solution would be started as soon as the collection of nasopharyngeal swab for RT-PCR is completed. <br>2. Following that Nasopharyngeal Wash and pharyngeal gargle would be continued for 48 hours: Daily in the morning and night.<br>3. Repeat collection of nasopharyngeal swab for RT-PCR to be done after 2 days in the morning 12 hours intermission from last nasopharyngeal wash and pharyngeal gargle.<br>4. Frequency of nasopharyngeal wash and pharyngeal gargle would be adjusted according to post-wash Virion Load.<br>5. Monitoring of biochemical, radiological parameters as per standard protocol would be continued both in control and in study group. <br><br>Intervention2: Nasopharyngeal saline wash and shout gargle: Study group will be treated with Nasopharyngeal Saline wash along with Standard treatment for COVID 19 as follows. 1. Nasopharyngeal Wash with normal saline and pharyngeal SHOUT gargle with SALINE solution would be started as soon as the collection of nasopharyngeal swab for RT-PCR is completed. 2. Following that Nasopharyngeal Wash and pharyngeal SHOUT gargle would be continued for 48 hours: Daily in the morning evening and night. 3. Repeat collection of nasopharyngeal swab for RT-PCR to be done after 2 days in the morning 4 hours intermission from last nasopharyngeal wash and pharyngeal gargle. 4. Frequency of nasopharyngeal wash and pharyngeal gargle would be adjusted according to post-wash Virion Load. 5. Monitoring of biochemical, radiological parameters as per standard protocol would be continued both in control and in study group.<br>C→ | Reduction or absence of Virion Load in RT-PCR/ in patients of COVID-19 following nasopharyngeal wash would prevent Transmissibility, Severity and Fatality. Prophylactic Nasopharyngeal Wash with normal saline and pharyngeal gargle might prevent production of Virion Load that might avert COVID19 in population at large.Timepoint: At Baseline, after 2days and after 4 days.→ | | 05/01/2021 | | Yes | False | | |
| → | CTRI/2020/08/027466 | 27 January 2021 | Outcomes of liver and pancreatic caner surgery during the COVID-19 pandemic | COVID-IHPBA: A snapshot study on the outcomes of hepatobiliary and pancreatic surgery during the COVID-19 pandemic: an international, multicentre, observational cohort study | | Tata Memorial Hospital | 29-08-2020 | 20200829 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46198 | Not Recruiting | No | | | | 31-08-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India;United States of America;Germany;France;Ireland→ | Shailesh V Shrikhande→ | | Department of surgical oncology tata memorial hospital
12th floor room no 1222 homibhabha block dr ernest borges marg parel mumbai → | shailushrikhande@hotmail.com→ | 9820224761→ | Tata Memorial Hospital→ | Inclusion criteria: 1) Adults age more than equal to 18 years with a confirmed diagnosis requiring HPB surgery, both benign and malignant <br/ ><br> <br/ ><br>2) Cholecystectomy will be included as â??basicâ?? HPB surgery with very low morbidity and almost null mortality.→ | Exclusion criteria: 1) HPB Surgery performed in the trauma setting. <br/ ><br> <br/ ><br>2) HPB Surgery performed as a synchronous case with another specialty â?? e.g. synchronous colonic and liver resections. <br/ ><br> <br/ ><br>3) Liver transplantation <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To evaluate the outcomes in all patients undergoing hepatobiliary and pancreatic HPB surgery outside liver or pancreas transplantations during the COVID-19 pandemic.Timepoint: 6 month→ | | | | Yes | False | | |
| → | CTRI/2020/08/027501 | 27 January 2021 | A study to assess aspects of safety and efficacy of Nuvastaticâ?¢ (C5OSEW5050ESA) as an immunomodulator supportive treatment to the standard care of treatment in Covid 19 patients. | An open label proof of concept study to assess aspects of safety and efficacy of Nuvastaticâ?¢ (C5OSEW5050ESA) as an immunomodulator adjuvant therapy to the standard care of treatment in Covid 19 patients. - Covid Nuvastatic | | NatureCeuticals Sdn Bhd | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44303 | Not Recruiting | No | | | | 10-09-2020 | 10 | Interventional | Other<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Divya C→ | | #2/5, 3rd Floor Dahlia Building, 80ft Road, RMV 2nd Stage, → | pm@bioagiletherapeutics.com→ | 080-43754520→ | BioAgile Therapeutics Pvt Ltd→ | Inclusion criteria: Subject will be included in the study if all the below criteria are â??yesâ?? <br/ ><br>1. Male and nonpregnant female patients 18 years of age or older eligible if they had a diagnostic specimen that was positive on RT-PCR. <br/ ><br>2. For Mild â?? Moderate cases: Positive nasal swab test for Covid 19 at screening. <br/ ><br>3. For Severe cases - Has an oxygen saturation (Sao2) of 94% or less while they are breathing ambient air or a ratio of the partial pressure of oxygen (Pao2) to the fraction of inspired oxygen (Fio2) (Pao2:Fio2) at or below 300 mg Hg. <br/ ><br>4. Ability to understand and the willingness to sign a written informed consent document. <br/ ><br>→ | Exclusion criteria: 1.Female subjects who are pregnant or breastfeeding. <br/ ><br>2. Patients who are allergic to this medicine <br/ ><br>3. Patients allergic to content of study product <br/ ><br>4. Patients with diabetes. <br/ ><br>5. Patients accompanied by serious physical diseases of heart, lung, brain, etc. <br/ ><br>6. Patients have any condition that in the judgement of the Investigators would make the subject inappropriate for entry into this study. <br/ ><br>7. Patients who are not able to take drugs orally. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J708- Respiratory conditions due to other specified external agents
→ | Intervention1: Nuvastaticâ?¢ (C5OSEW5050ESA): Nuvastaticâ?¢ (C5OSEW5050ESA) in the form of powder to be reconstituted in water to be consumed thrice daily (morning, afternoon and evening (one sachet each) to be taken for 14days.<br>Control Intervention1: Placebo: Placebo in the form of powder to be reconstituted in water to be consumed thrice daily (morning, afternoon and evening (one sachet each) to be taken for 14days.<br>→ | time to clinical improvement, defined as the time from randomization to an improvement of two points (from the status at randomization) on a seven-category ordinal scale or live discharge from the hospital, whichever comes first. <br/ ><br> <br/ ><br>3. Change in standard diagnosis: Serum c-reactive protein (CRP), IgG, Hb, Total leucocyte count and differential leucocyte count. <br/ ><br>4. Change in urinary F2-Isoprostane from baseline to remission <br/ ><br>Timepoint: Screening and Day14→ | | | | Yes | False | | |
| → | CTRI/2020/08/027494 | 27 January 2021 | To identify the pathogenesis of COVID-19 at different stages with the help of Ayurveda | Identifying the pathological models of COVID-19 in Ayurveda: Shat kriyakala & Vikara Vighata bhava abhava -A cross sectional study | | All India Institute of Ayurveda | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46900 | Not Recruiting | No | | | | 06-09-2020 | 75 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Tanuja Nesari→ | | Director office Ground floor C block All India Institute of Ayurveda Gautampuri Sarita vihar New Delhi → | asthmatamv@gmail.com→ | 9958817145→ | All india Institute of Ayurveda→ | Inclusion criteria: Patients >20 yrs. <br/ ><br>SARS COV-2 confirmed by RT PCR/RAD <br/ ><br>Mild to moderate category <br/ ><br>patients with potential risk factor <br/ ><br>Patient willing to participate→ | Exclusion criteria: Patient unwilling to take part <br/ ><br>Unconscious patient→ | Health Condition 1: B342- Coronavirus infection, unspecified
→ | | To validate concept of shatkriyakala and vikara vighat bhava abhava in pathogenesis of covid-19Timepoint: 2 MONTHS→ | | | | Yes | False | | |
| → | CTRI/2020/08/027475 | 27 January 2021 | A Randomized Controlled Trial Of An Immunomodulator Mycobacterium w In Mild To Moderate Covid-19 Pneumonia | "Randomized Controlled Trial Of Immunomodulator Mycobacterium w In Mild And Moderate Cases of Covid-19 Pneumonia" | | Cadila Pharmaceuticals Limited | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45627 | Recruiting | No | | | | 01-09-2020 | 30 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Double Blind Double Dummy | Phase 3 | India→ | Dr Shweta Ram Chandankhede→ | | Care Hospital,Banjara Hills, Hyderabad. → | shwets0106@gmail.com→ | 9963431945→ | Care Hospital, Banjara Hills→ | Inclusion criteria: Age More Than 18 in both genders. <br/ ><br>Mild to moderate covid 19 pneumonia <br/ ><br>Consented for study→ | Exclusion criteria: Pregnancy, <br/ ><br>Received cardiopulmonary resuscitation, <br/ ><br>On long standing immunosuppressive therapy, <br/ ><br>Unwilling to provide consent. <br/ ><br>Complete blood count serum Dâ??dimer, Câ??reactive protein (CRP), procalcitonin and IL6 levels will be done for all patients. As per our institutional protocol, all patients will receive standard medical care comprising oral paracetamol (for fever), oral proton pump inhibitor for stress ulcer prophylaxis (pantoprazole 40 mg/day), and low molecular weight heparin for deep venous thrombosis prophylaxis (enoxaparin 1 mg/kg, once daily). Therapeutic anticoagulation (enoxaparin 1 mg/kg, twice daily) will be given in patients who will have D dimer levels >500 ng/ mL. Dexamethasone 6 mg iv daily will be used for 7 days. Antibiotics (azithromycin or doxycycline ) will be used in patients with a total leukocyte count of >11,000 cell/μL, procalcitonin >0.5 ng/mL, or if they have hypotension (mean arterial blood pressure <65 mmHg). We will not use hydroxychloroquine in any of these patients. We will use intradermal Mw (0.3 mL/day [0.1 mL contains 0.5 Ã? 109 heat- killed Mw] for 3 consecutive days, in addition to standard medical care. <br/ ><br>→ | Health Condition 1: B342- Coronavirus infection, unspecified
→ | Intervention1: inj sepsivac 0.3 ml intradermal once a day for 3 days: inj sepsivac 0.3 ml intradermal once a day for 3 days<br>Control Intervention1: normal saline: 0.3 ml intradermal once a day for 3 days<br>→ | 28 days mortalityTimepoint: 28 days mortality→ | | | | Yes | False | | |
| → | CTRI/2020/08/027502 | 27 January 2021 | Comparison two types of artificial respiration in severe COVID-19 patients | Airway Pressure Release Ventilation versus Low- Tidal Volume Ventilation in SARS- CoV-2 Infected ARDS Patients: A Randomized Controlled Trial | | Dr Souvik Maitra | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44862 | Not Recruiting | No | | | | 10-09-2020 | 216 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | Dr Souvik Maitra→ | | Room No: 5011, Teaching Block
All India Institute of Medical Sciences,
Ansari Nagar → | souvimaitra@live.com→ | 8146727891→ | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: Adult patients (aged between 18 & 75y) of either sex with laboratory confirmed SARS- CoV-2 infection, fulfilling Berlin definition of ARDS requiring invasive mechanical ventilation will be included in this study.→ | Exclusion criteria: 1. Refusal to participate <br/ ><br>2. Moribund patients with life expectancy less than 48h <br/ ><br>3. Pregnancy <br/ ><br>4. Patients requiring more than 20mcg/min of noradrenalin support or equivalent dose of another inotropes/ vasopressor <br/ ><br>5. Co-existing chronic obstructive pulmonary disease <br/ ><br>6. Co- existing Neuro-muscular diseases <br/ ><br>7. Recruitment in another randomized trial <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Airway Pressure Release Ventilation: Patients will be transitioned from their previous volume assist-controlled ventilation to APRV with the following initial settings: high airway pressure (Phigh) of at the Pplat measured during previous VCV settings, not to exceed 30 cm H2O; low airway pressure (Plow) will be set at 5 cm H2O (minimal pressure level was used to prevent atelectasis per standard practice); duration of release (Tlow) will be set as 1.5 times of expiratory time constant and further adjusted to achieve 75% of peak expiratory flow rate. Thigh will be around 5s to achieve a release frequency of 10- 14/min.<br>Control Intervention1: Low tidal volume (LTV) ventilation: In the LTV group, tidal volume target will be 6 mL/ kg PBW, with allowances for 4â??8 mL/kg PBW to minimize asynchrony between the patient and ventilator; PEEP levels will be adjusted by the ARDSnet PEEP-FiO2 table, and then tidal volume and the respiratory rate will be regulated to achieve the above target pH. When PFR is 150, PEEP will be tittered on the basis of lowest driving pressure.<br>→ | whether APRV reduces intensive care unit (ICU) mortality over LTV in mechanically ventilated SARS- CoV-2 infected patients with ARDSTimepoint: 28- day post randomization→ | | | | Yes | False | | |
| → | CTRI/2020/08/027477 | 27 January 2021 | Evaluation of safety and efficacy of T-AYU-HM Premium and Onion steam vaporization/nebulization in Covid-19 patients. | Evaluation of safety and efficacy of T-AYU-HM Premium and Onion Steam vaporisation/nebulization in Covid-19 patients (mild to moderate) | | Dhanvantari Clinic Ayurveda Health Care and Research Center | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46654 | Not Recruiting | No | | | | 03-09-2020 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Dr Hemshree Desai→ | | ATBU Harita Pharmaceuticals Pvt ltd.
Room No:110, Shreeji Desai Market
Sardar Chowk
Vyara
→ | dratuldesai@rediffmail.com→ | 9879031621→ | Dhanvantari Clinic, Ayurveda health care and research center→ | Inclusion criteria: 1. Age 18-80 years, <br/ ><br>2. Both male and female <br/ ><br>3. Mild to Moderate cases under home quarantine. <br/ ><br>4. Willing to perform onion vaporization/nebulizationâ?¨ once a day <br/ ><br>5. Patients able to consume oral formulations. <br/ ><br>6. Willing to provide informed consent. <br/ ><br>→ | Exclusion criteria: 1. Require mechanical ventilation <br/ ><br>2. Unable to perform onion vaporization/nebulisation once a day. <br/ ><br>3. Having serious stages illness <br/ ><br>4. Pregnant/lactating women <br/ ><br>5. Children below 18 years age <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tablet T-AYU-HM Premium: 600mg orally BD for 21 days.<br><br>Intervention2: Onion steam vaporization/nebulisation <br>: Nasally OD for 21 days<br>Control Intervention1: NA: NA<br>→ | 1. Total number of participants with improvement in clinical symptoms â?? fever, Cough, Fatigue, Shortness of breath, Expectoration, Myalgia, Rhinorrhoea, Sore throat, Diarrhoea, Loss of smell (anosmia), Loss of taste (ageusia). <br/ ><br>2. Total number of participants with resolution of clinical symptoms fever, Cough, Fatigue, Shortness of breath, Expectoration, Myalgia, Rhinorrhoea, Sore throat, Diarrhoea, Loss of smell (anosmia), Loss of taste (ageusia).Timepoint: 21 days→ | | 08/10/2020 | | Yes | False | | |
| → | CTRI/2020/08/027499 | 27 January 2021 | Role of siddha medicine in the management of covid -19 | â??An Open Clinical Trial to Evaluate the Safety & Efficacy of Siddha Sastric Medicines â?? Fixed Regimen in COVID-19 Positive asymptomatic mild or moderate cases with reference to the Siddha guidelines of COVID-19 management Ministry of AYUSH Govt of India at SIDDHA COVID CARE CENTER Sri Arcot Mahalakshmi Nursing College Campus Vilappakkam Ranipet District Tamilnadu
| | MrsDivyadharshini IAS | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46927 | Recruiting | No | | | | 05-09-2020 | 20 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 2 | India→ | DRASUGANYA→ | | Siddha wing,
Govt Headquarters Hospital
Walaja. Anna Hospital Campus, Arumbakkam, Chennai→ | drsuganyamd@gmail.com→ | | DEPARTMENT OF INDIAN MEDICINE AND HOMEOPATHY→ | Inclusion criteria: S.No Parameter <br/ ><br>1. Adult Male/Female subjects above the age of 18 years <br/ ><br>2. COVID -19 Positive as determined by RT-PCR <br/ ><br>3. Willing to provide written/digital informed consent. <br/ ><br>4. COVID - 19 Positive with no clinical signs <br/ ><br>5. COVID - 19 Positive with mild symptoms â?? Sneezing, Cough, Sore Throat, Throat Pain, Malaise, Tiredness, Fever, loss of smell, loss of taste <br/ ><br>6. COVID - 19 Positive with moderate symptoms â?? Fever with cough, breathlessness but respiratory rate <24 per minute and Oxygen saturation > 95% at rest <br/ ><br>→ | Exclusion criteria: S. No Parameter <br/ ><br>1. Pregnant and Lactating females <br/ ><br>2. COVID - 19 Positive with Severe symptoms â?? Respiratory distress ( >24 breath per minute), Oxygen saturation < 95% at rest, Respiratory failure, Need of Mechanical Ventilation, Septic shock, Non respiratory organ failure <br/ ><br>3. Chronic Renal Failure requiring dialysis (eGFR < 30) <br/ ><br>4. Known cases of uncontrolled Diabetes ( >9% HbA1c) <br/ ><br>5. Known cases of stage 3 Hypertension ( > 160/100 mmHg) <br/ ><br>6. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>7. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>8. Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>9. Subjects who are participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>10. Subjects with bleeding disorders and severe anemia (Hb <7 g/dL) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 1. Kaba Sura Kudineer Chooranam â?? Decoction â?? Two times daily before 30 min of meals for 7 days<br>2. Adathodai manapagu â?? 10 ml â??Twice daily with warm water after meals for 7 days <br>3. Amukkara Chooranam Mathirai 500 mg â?? 2 tablet - Three times daily after meals for 7 days with warm water<br>4. Thaleesadhi vadagam Mathirai 500 mg â?? 2 tablet â?? Three times daily after meals Chewable for 7 days with warm water<br>5. Brammanandha bairavam 100 mg â?? 2 pills - Two times daily after meals for 7 days with ginger juice/honey.: 1. Kaba Sura Kudineer Chooranam â?? Decoction â?? Two times daily before 30 min of meals for 7 days<br>2. Adathodai manapagu â?? 10 ml â??Twice daily with warm water after meals for 7 days <br>3. Amukkara Chooranam Mathirai 500 mg â?? 2 tablet - Three times daily after meals for 7 days with warm water<br>4. Thaleesadhi vadagam Mathirai 500 mg â?? 2 tablet â?? Three times daily after meals Chewable for 7 days with warm water<br>5. Brammanandha bairavam 100 mg â?? 2 pills - Two times daily after meals for 7 days with ginger juice/honey.<br>one week dosage, oral route of administration<br>Control Intervention1: nil: nil<br>→ | Reduction in Viral load of SARS-CoV-2 at the end of treatment <br/ ><br>Reduction in clinical symptoms like fever, cough and breathlessness <br/ ><br>(1. Fever: â?¤36.6°C or -axilla, â?¤37.2 °C oral or â?¤37.8°C rectal or tympanic ; <br/ ><br>(2. Respiratory rate - â?¤24/minute on room air; <br/ ><br>(3. Cough - mild or absent on a patient reported scale (cough symptoms score â?¤ 2 points) <br/ ><br>Timepoint: one week <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/08/027468 | 27 January 2021 | HRCT chest imaging in pediartic, adult and geriatric patients with COVID-19 infection | â??Comparison of HRCT features in pediatric ,adult
and elderly COVID-19 patients and itsâ?? affect on
overall morbidity - a study in a dedicated
COVID hospital of Odishaâ?? | | Dr Mayank Goyal | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46446 | Not Recruiting | No | | | | 01-09-2020 | 900 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Investigator Blinded | N/A | India→ | Dr Mayank Goyal→ | | Department of Radiology, Kalinga Institute of Medical Sciences, Bhubaneswar → | kamal.sen@kims.ac.in→ | 7064333377→ | Kalinga Institute of Medical Sciences→ | Inclusion criteria: All the COVID positive cases of different age groups who underwent HRCT thorax on admission and before discharge→ | Exclusion criteria: 1. Clinically suspected COVID 19 cases which remained negative on RT-PCR testing. <br/ ><br>2. Those COVID positive patients, who have not undergone HRCT Chest both on admission and on discharge. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Age groups were divided into 3 broad categories: Pediatrics (18years), adults(18-60years) and elderly (60years) COVID positive cases and these age groups were separately analysed on HRCT chest for different imaging features.Timepoint: Study conducted for a period of 4 weeks to 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/08/027500 | 27 January 2021 | Study for predicting hypoxemia in COVID 19 patients on the basis of HRCT thorax findings with correlating the CT findings with SpO2 levels. | â??HRCT Thorax - Is it an early predictor of hypoxemia in COVID 19 patients?â?? | | kalinga Institute of medical scineces | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46721 | Not Recruiting | No | | | | 31-08-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Kamal Kumar Sen→ | | Department of Radiodiagnosis, kalinga institute of medical sciences, KIIT University, Patia, Bubaneswar, Odisha. → | drajay2610@gmail.com→ | 7453866819→ | kalinga institute of medical sciences→ | Inclusion criteria: All COVID positive patients with positive HRCT thorax features with simultaneous SpO2 monitoring .→ | Exclusion criteria: Patients who have not undertaken HRCT thorax and SpO2 monitoring. <br/ ><br> <br/ ><br>Patients with normal HRCT thorax . <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Assessing the potential for prediction of hypoxemia on HRCT thorax and Early prediction of hypoxemia if feasible, would guide physicians for prompt and early management of COVID 19 patients with low blood oxygen levels. <br/ ><br>Timepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/08/027492 | 27 January 2021 | Mental health status, adjustment strategies due to covid19 pandemic and related factors | Mental health status, coping strategies owing to covid19 pandemic and associated factors among students of healthcare profession | | NA | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46983 | Not Recruiting | No | | | | 06-09-2020 | 400 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Jayanti MIshra→ | | Department of Physiology, campus-5, KIMS, KIIT University C5/2, Chandrama Complex, Kharavela Nagar, Bhubaneswar, Odisha, 751001→ | jayanti.mishra@kims.ac.in→ | 9438461373→ | Kalinga Institute of Medical Sciences, KIIT University.→ | Inclusion criteria: Four hundred first year and second year students of Medical,Dental and Nursing School→ | Exclusion criteria: Those students having Known cardiovascular, respiratory and endocrine abnormalities or any other systemic diseases→ | | | Significant number of subjects may be having a mental status amounting to depression and the coping strategies maynot be appropriate among them.Timepoint: Twelve Weeks→ | | | | Yes | False | | |
| → | CTRI/2020/08/027490 | 27 January 2021 | Neurological manifestations of COVID-19 | NEPSycon-COVID: Assessment of Neurological, Epidemiological, Psychiatric and Psychosocial Consequences during the COVID -19 Pandemicâ?? - NEPSycon-COVID | | NIHRLiverppol University | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47009 | Not Recruiting | No | | | | 10-09-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India→ | Ravi Vasanthapuram→ | | Department of Neurovirology, NIMHANS
Bangalore Hosur road→ | sundernetra@yahoo.co.in→ | 9880106662→ | National Institute of mental health & Neurosciences (NIMHANS), Bangalore 29→ | Inclusion criteria: Methodology: <br/ ><br>Participants: All neurological patients visiting the neurological emergency with the following inclusion and exclusion criteria will be included into the study: <br/ ><br>1. Inclusion criteria: <br/ ><br>a. Patients of Neurological disorders with previously described symptoms related to COVID-19 infection such as: Young Stroke (cerebrovascular accident), Stroke (cerebrovascular accident) patients with deranged prothrombotic states/elevated D-dimer assays, Acute encephalitis, Seizure of unknown etiology, Guillain barre syndrome, Myositis with elevated CPK, para-infectious neurological disorders in the form of myelitis, ADEM, CNS Demyelinating disorders <br/ ><br>b. Patients of neurological disorders precipitated or preceded by respiratory symptoms in the last 2-4 weeks <br/ ><br>c. Patients of neurological symptoms (not fitting the criteria of a/b) but found to have lymphopenia / thrombocytopenia /thrombotic states / elevated D-dimer levels <br/ ><br>2. Exclusion criteria: <br/ ><br>a. Patients of neurological disorders with a known etiology other than COVID-19 <br/ ><br>b. Not giving consent for the study <br/ ><br>Patients of neurological disorders with suspected COVID-positivity will be included into the study after fulfilling the inclusion and exclusion criteria. Then, they will undergo following assessment for further characterization of the neurological symptoms and signs. <br/ ><br>→ | Exclusion criteria: 2. Exclusion criteria: <br/ ><br>a. Patients of neurological disorders with a known etiology other than COVID-19 <br/ ><br>b. Not giving consent for the study <br/ ><br>→ | Health Condition 1: G998- Other specified disorders of nervous system in diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | The primary outcome will be death. Secondary outcomes of interest will be proportions of patients with each neurological diagnosis in the group with neurological disease; admission to a critical (intensive/high dependency) care unit; time to discharge from hospital; and functional outcome at discharge (or 30 days from admission, if still in hospital) - <br/ ><br>Timepoint: At initial diagnosis and then at 1 month, 3 months, 6 months and 12 months→ | | | | Yes | False | | |
| → | CTRI/2020/08/027491 | 27 January 2021 | benefits of Siddha medicines in covid-19 positive patients | â??An Open Clinical Trial to Evaluate the Safety & Efficacy of Siddha Sastric Medicines â?? Fixed Regimen in COVID-19 Positive asymptomatic, mild or moderate cases with reference to the Siddha guidelines of COVID-19 management, Ministry of AYUSH, Govt. of India at Agraharam Siddha COVID-19 CARE Centre , Thirupattur District ,Tamilnaduâ?? | | District Administration | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46256 | Not Recruiting | No | | | | 06-09-2020 | 20 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | DrPSathya Rajeshwaran→ | | Siddha Central Research Institute,
Chennai
Chennai→ | drvikramkumar86@gmail.com→ | 9944457603→ | Government PHC→ | Inclusion criteria: Adult Male/Female subjects above the age of 18 years <br/ ><br>COVID -19 Positive as determined by RT-PCR <br/ ><br>Willing to provide written/digital informed consent. <br/ ><br>COVID - 19 Positive with no clinical signs <br/ ><br>COVID - 19 Positive with mild symptoms â?? Sneezing, Cough, Sore Throat, Throat Pain, Malaise, Tiredness, Fever, loss of smell, loss of taste <br/ ><br>COVID - 19 Positive with moderate symptoms â?? Fever with cough, breathlessness but respiratory rate <24 per minute and Oxygen saturation > 95% at rest <br/ ><br>→ | Exclusion criteria: Pregnant and Lactating females <br/ ><br>COVID - 19 Positive with Severe symptoms â?? Respiratory distress ( >24 breath per minute), Oxygen saturation < 95% at rest, Respiratory failure, Need of Mechanical Ventilation, Septic shock, Non respiratory organ failure <br/ ><br>Chronic Renal Failure requiring dialysis (eGFR < 30) <br/ ><br>Known cases of uncontrolled Diabetes ( >9% HbA1c) <br/ ><br>Known cases of stage 3 Hypertension ( > 160/100 mmHg) <br/ ><br>Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>Subjects taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>Subjects who are participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>Subjects with bleeding disorders and severe anemia (Hb <7 g/dL) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: KabaSuraKudineerChooranam: Decoction â?? Two times daily before 30 min of meals for 7 days<br>Intervention2: AmukkaraChooranamMathirai: 2 tablet - Three times daily after meals for 7 days<br>Intervention3: Thaleesadhivadagam: 2 tablet â?? Three times daily after meals Chewable for 7 days<br>Intervention4: Brammanandhabairavam: 1 pills - Two times daily after meals for 7 days<br>Intervention5: Adathodaimanapagu: 10 ml â??Twice daily with warm water after meals for 7 days<br>Control Intervention1: Nil: Nil<br>→ | Reduction in Viral load of SARS-CoVid 2 at the end of treatment <br/ ><br>Reduction in clinical symptoms like fever, cough and breathlessness <br/ ><br>Fever: â?¤36.6°C or axilla, â?¤37.2 °C oral or â?¤37.8°C rectal or tympanic <br/ ><br>Respiratory rate - â?¤24/minute on room air <br/ ><br>Cough - mild or absent on a patient reported scale (cough symptoms score â?¤ 2 points) <br/ ><br>Timepoint: 7 days→ | | 20/10/2020 | | Yes | False | | |
| → | CTRI/2020/08/027503 | 27 January 2021 | Effect of blood thinning medicine in COVID-19 infection | Low Dose Aspirin in Moderate to Severe SARS- CoV-2 Infected Patients: A Pilot Randomized Controlled Trial | | Dr Souvik Maitra | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44980 | Not Recruiting | No | | | | 15-06-2021 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Dr Souvik Maitra→ | | Room No: 5011, 5th Floor Teaching Block, All India Institute of Medical Sciences, New Delhi → | souvikmaitra@live.com→ | 08146727891→ | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: Adult (aged between 18 and 65y) patients with laboratory confirmed SARS- CoV-2 infection with hypoxemia (defined by room air SpO2 â?¤ 94%) at the time of randomization will be included.→ | Exclusion criteria: 1. Refusal to participate <br/ ><br>2. Mechanically ventilated patients <br/ ><br>3. Patients with P/F ratio < 150 mm Hg <br/ ><br>4. Patients with any known coagulation disorder <br/ ><br>5. Patients with known platelet function disorder <br/ ><br>6. Patients who are already on antiplatelet therapy <br/ ><br>7. Patients with thrombocytopenia (platelet count < 100,000/ cmm) <br/ ><br>8. Patients with any previous intracranial pathology <br/ ><br>9. Patients with known gastric/ duodenal ulcer <br/ ><br>10. Patients with history of gastro-intestinal bleeding within 3 months <br/ ><br>11. Pregnancy women or women who are breastfeeding their children <br/ ><br>12. Known allergy to aspirin <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Aspirin: Low dose aspirin (75 mg OD) for 10 days along with standard of care<br>Control Intervention1: Standard of Care: Standard of care will included standard practice of the institute at that time<br>→ | To compare SpO2/ FiO2 ratio in day 1- 7 post randomization in both the groupsTimepoint: day 1- 7 post randomization→ | | | | Yes | False | | |
| → | CTRI/2020/08/027467 | 27 January 2021 | Effect of Allo-vedic Preparation Raj Nirwan Bati (RNB) on Severe COVID-19 Patients | Therapeutic Response of Allo-vedic Preparation Raj Nirwan Bati (RNB) on Severe COVID-19 Patients: A Double-Blind Randomized Placebo Controlled Clinical Trial - RNB COVID-19 | | Uttar Pradesh University of Medical Sciences | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46524 | Not Recruiting | No | | | | 31-08-2020 | 40 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Dr Raj Kumar→ | | Department of Neurosurgery, Uttar Pradesh University of Medical Sciences, Saifai, Etawah, Uttar Pradesh, India → | vcoffice@upums.ac.in→ | 05688276563→ | Uttar Pradesh University of Medical Sciences (UPUMS)→ | Inclusion criteria: 1. RT-PCR confirmed SARS-CoV-2 infected patients. <br/ ><br>2. Patients who are symptomatic with severe category of COVID-19 illness including critically ill patients admitted to the dedicated COVID-19 hospital of UPUMS. <br/ ><br>3. Patients aged 18 years and above. <br/ ><br>4. Patients with history of immergence of clinical symptoms of COVID-19 less than 10 days on the day of admission to the dedicated COVID-19 hospital. <br/ ><br>5. The patient or his/her representative providing informed consent to participate in the study. <br/ ><br>→ | Exclusion criteria: 1. Patients who are either asymptomatic or having mild or moderate COVID illness. <br/ ><br>2. Patients who take medication for less than 4 days after enrolment in the study. <br/ ><br>3. Study participants deteriorating by two points on the clinical improvement ordinal scale designed for the study during the course of intervention. <br/ ><br>4. Patients with established unresponsive improvement to treatment for co-morbidities. <br/ ><br>5. Patients who discontinue the intervention for any reason. <br/ ><br>6. Pregnant and lactating females. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B348- Other viral infections of unspecified site
→ | Intervention1: Raj Nirwan Bati (RNB capsule): 250 mg twice a day on day 1 and subsequently 125 mg twice a day till 12 days after admission<br>1. Mercury (Para) 2. Sulphur<br>(Gandhak) 3. Gold (Sona) 4.<br>Silver (Chandi) 5. Clamina<br>Perpeta 6. Arsenic Trioxide<br>(Hartal Bhasma) 7. Black<br>pepper (Kaali Mirch) 8. Naag<br>Damanti (Snake Plant) 9. Celery<br>(Azwaiyan) 10. Zinc 11.<br>Niramish (Mahamash oil)<br>Control Intervention1: Sugar Capsule: Sugar powder in capsule<br>one capsule twice a day till day 12 of admission.<br>→ | Clinical improvementTimepoint: Assessment will be done at baseline, Day 6, day 12 and Day 18 of admission for Two-point reduction in patientsâ?? clinical status at admission on a six-point ordinal scale, or live discharge from the hospital.→ | | | | Yes | False | | |
| → | CTRI/2020/08/027470 | 27 January 2021 | Anaesthesia practices and safety of caregivers during the covid 19 pandemic. | Practice modifications in anesthesia in cancer patients undergoing surgery during the Covid-19 pandemic â?? a retrospective audit over four months. - Not applicable | | Max Super Speciality Hospital Saket | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45806 | Not Recruiting | No | | | | 01-09-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Nambiath Sujata→ | | Department of General Anaesthesia and Pain management,
First floor, East Block
Max Super Speciality Hospital,
No.2 Press Enclave Road, Saket. → | drnambiath@yahoo.com→ | 9999109402→ | Max Super Speciality Hospital, Saket→ | Inclusion criteria: All cancer patients undergoing surgery in Max Super Speciality Hospital, Saket, New Delhi from 1st April 2020 to 31st July 2020→ | Exclusion criteria: Nil exclusions→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To identify the safety practices adopted in anesthesia and intensive care to minimize transmission of Covid-19 to healthcare workers during the pandemic.Timepoint: Data collected retrospectively after 15th August for surgeries done between 1st April 2020 to 31st July 2020workers during the pandemic.→ | | | | Yes | False | | |
| → | CTRI/2020/08/027471 | 27 January 2021 | Association of COVID-19 severity with blood group antigens. | Study to explore association of COVID-19 disease severity with clinically significant blood group antigenic constitution. - BG-CoV | | AIIMS | 31-08-2020 | 20200831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45049 | Not Recruiting | No | | | | 01-09-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Diptiranjan Rout→ | | Dept. of Transfusion Medicine, Room No. 13, Academic Block, NCI-AIIMS, Badsa, Jhajjar → | drdiptiranjanrout@gmail.com→ | 08727804293→ | AIIMS→ | Inclusion criteria: 1.Written informed consent to participate in the study. <br/ ><br>2.Confirmed SARS CoV-2 infection; <br/ ><br>3.Adults (Age range: 18-64 years). <br/ ><br>→ | Exclusion criteria: 1.Failure to obtain Written informed consent; <br/ ><br>2.Known history of any transfusions in the last 3 months; <br/ ><br>3.Children (Age range: Birth â?? 17 years) and Older adults (Age range: > 65 years). <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Establishing a relation between COVID-19 patients of symptomatology and blood group antigenic constitution. <br/ ><br>b) Exploring a predictive tool for COVID-19 in association with blood group antigenic constitution and patientâ??s clinical parameters which may be validated in further studies.Timepoint: 12 months→ | | | | Yes | False | | |
| → | CTRI/2020/09/027516 | 27 January 2021 | Coronavirus infection among healthcare workers | Prevalence, Clinical Presentations and treatment outcomes of COVID-19 among healthcare workers in TNMC and BYL Nair hospital | | Dr Niraj Mahajan | 01-09-2020 | 20200901 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46986 | Not Recruiting | No | | | | 07-09-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Niraj Mahajan→ | | Department of Obstetrics and Gynecology, Fourth floor, OPD Building, Nair Hospital, Mumbai Central, Mumbai 400008 → | nirajdr@hotmail.com→ | 09004696920→ | BYL Nair Charitable Hospital→ | Inclusion criteria: HealthCare Workers of TNMC and BYLNCH, recovered from COVID-19 till 31st July 2020→ | Exclusion criteria: HCWs suffering from COVID-19 not seeking treatment from TNMC will be excluded from the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J00-J99- Diseases of the respiratory system
→ | | 1. Prevalence of COVID-19 in HCWs at TNMC and BYL Nair Hospital <br/ ><br>2. Socio-demographic, epidemiological and clinical characteristics of HCWs with COVID-19 <br/ ><br>3. Outcomes in HCWs with COVID-19 <br/ ><br>Timepoint: 4 months→ | | | | Yes | False | | |
| → | CTRI/2020/09/027517 | 27 January 2021 | Management of cardiac disease during COVID 19 pandemic and impact among cardiologist in Tamil Nadu | COVID 19 and its impact on the management of patients with Acute Coronary Syndrome: A questionnaire based survey amongst Cardiologist in Tamil Nadu | | C Research Foundation | 01-09-2020 | 20200901 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47025 | Not Recruiting | No | | | | 07-09-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr B Vinod Kumar→ | | C3 Research Foundation,
Research Department,
Cardiology Division,
Room No:1,
No: 5/463, Valayapathi Salai,
J.J.Nagar, Mogappair East,
Chennai → | pulse@c3rf.com→ | | C3 Research Foundation→ | Inclusion criteria: All the cardiologist who treat COVID patients→ | Exclusion criteria: Other speciality doctors <br/ ><br> <br/ ><br>Cardiologist who did not treat COVID patients <br/ ><br>→ | | | To know the impact of COVID in managing patients with acute coronary syndromeTimepoint: Baseline→ | | 25/09/2020 | | Yes | False | | |
| → | CTRI/2020/09/027535 | 27 January 2021 | Efficacy and safety study of antiviral Umifenovir therapy in non-severe COVID-
19 patients. | Phase 3, Randomized, Double-blind, Placebo control trial of Efficacy, Safety and Tolerability of Antiviral drug Umifenovir vs Standard care of therapy in non-severe COVID-19 patients. | | Director CSIR Central Drug Research Institute | 01-09-2020 | 20200901 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45236 | Recruiting | No | | | | 08-09-2020 | 132 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Dr Vivek Bhosale MD→ | | CSIR-Central Drug Research Institute, Department of Toxicology and Experimental Medicine, Lab no. PCN05, Sector 10, Jankipuram Extension, Sitapur Road, Lucknow, U.P., India. → | drvivekbhosale@cdri.res.in→ | 9450902041→ | CSIR-Central Drug Research Institute→ | Inclusion criteria: 1. Asymptomatic persons WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens. <br/ ><br>2. Case categories as uncomplicated illness, Mild pneumonia, Moderate pneumonia according to severity WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens as per Ministry of health & Family welfare, Govt of India guidelines. Patients with uncomplicated upper respiratory tract viral infection may have non-specific symptoms such as fever, cough, expectoration, shortness of breath, myalgia, fatigue, sore throat, nasal congestion, diarrhea, loss of taste WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens. <br/ ><br>Mild pneumonia WITH Nasopharyngeal swab positivity in RT-PCR tests for SARS-Cov-2 antigens. Moderate pneumonia is defined as Adults with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, Respiratory Rate more or equal to 24 per minute. <br/ ><br>3. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period. <br/ ><br>4. Not participating in any other interventional drug clinical studies before completion of the present study. <br/ ><br> <br/ ><br>→ | Exclusion criteria: â?¢ Severe COVID-19, as defined in Ministry of Health, Govt of India guidelines. Adolescent or adult: fever or suspected respiratory infection, plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air, Cases of Acute respiratory distress syndrome (ARDS). <br/ ><br>â?¢ Sepsis, Septic shock as defined in MOH&FW guidelines. The cases as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. Inability to intake or tolerate oral medications. <br/ ><br>o Known allergy or hypersensitivity to Umifenovir <br/ ><br>o Possibility of the subject being transferred to a non-study hospital within 72h <br/ ><br>o Pregnant or lactating women <br/ ><br>o Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN; <br/ ><br>o Known severe renal impairment [creatinine clearance (CcCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis. <br/ ><br>O Known disease or comorbid condition like asthma, diabetes with second-and third-line medicines, insulin as defined in WHO guidance document.18 <br/ ><br>O The disease or condition which may affect the study as decided by physician. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Umifenovir: Oral Umifenovir 800mg twice daily for 14 days + standard care of therapy.<br>Control Intervention1: Standard of care: Standard of care for COVID-19<br>→ | Time from randomization to nasopharyngeal swab negativity by RT-PCR tests. <br/ ><br>For moderate patients, the end point will be time to improvement by one category from randomisation on the eight-category ordinal scale defined by WHO & average change in the ordinal scale from baseline.Timepoint: For examination and other tests, the time points are baseline, 7, 14, 21, 28 days. The nasopharyngeal swab testing will be done at baseline, fifth day and subsequently every 48 hours upto 21 days and then on 28 day or till it becomes negative whichever is earlier.→ | | | | Yes | False | | |
| → | CTRI/2020/09/027518 | 27 January 2021 | Compare marker abnormalities in COVID positive and negative cancer patients | Comparative evaluation of hematologic and biochemical biomarker abnormalities associated with perioperative management of COVID positive and negative cancer patients: A Pilot study | | Department of anaesthesia AIIMS Rishikesh | 01-09-2020 | 20200901 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47089 | Not Recruiting | No | | | | 13-09-2020 | 40 | Observational | Non-randomized, Placebo Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Bhavna Gupta→ | | Department of anesthesia AIIMS hospital Veerbhadra marg Rishikesh
249203
India → | bhavna.kakkar@gmail.com→ | 8527686660→ | AIIMS, Rishikesh→ | Inclusion criteria: 1.Cancer patients, Aged 18 to 70 years <br/ ><br>2.American Society of Anesthesiologist Grade I-III <br/ ><br>3.Patient undergoing oncological surgery. <br/ ><br>→ | Exclusion criteria: 1.Any contraindication to general anesthesia <br/ ><br>2.Patients with existing acute infection, sepsis. <br/ ><br>3.Patients on recent chemotherapy(past 15 days). <br/ ><br>4.Patient on chronic treatment with steroids or immune-suppressants. <br/ ><br>5.Patient who are morbidly obese, have autoimmune disorders. <br/ ><br>6.Patient underwent blood transfusion for < 1 week <br/ ><br>7.Patients not willing to give consent <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: nil: nil<br>Control Intervention1: nil: nil<br>→ | Difference in biochemical and hematological markers (CBC, TLC, ESR, CRP, PCT, Ferritin, D-Dimer , IL-6,IL-10 and TNF alpha) at three time points (preoperatively, immediately and 24hours after the end of the surgery) in COVID positive and negative cancer patients undergoing major oncological surgery.Timepoint: Baseline, <br/ ><br>Before giving anaesthesia, <br/ ><br>At end of surgery and <br/ ><br>24H after surgery <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/09/027548 | 27 January 2021 | Effects of health drink additional to standard of care treatment in COVID 19 patients. | Effect of Mulmina Mango as an adjunct to standard of care treatment on COVID-19
positive subjects undergoing treatment for COVID-19 in Hospital Quarantine (Dedicated Covid
Health Centre). | | Jagdale Industries Pvt Ltd | 02-09-2020 | 20200902 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47125 | Not Recruiting | No | | | | 12-09-2020 | 50 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Subham Dutta→ | | 2nd Main Road, Building #06, 3rd Floor.
Arekere, Sarvobhogam Nagar.
Bangalore 560076. KA INDIA → | raghavendra.kv@jagdale.com→ | 9845345469→ | Jagdale Industries Pvt Ltd→ | Inclusion criteria: 1. Male or non-pregnant female between 20 to 65 years (both inclusive) <br/ ><br>of age at the time of enrolment. <br/ ><br>2. Subject or LAR providing written informed consent and agrees to <br/ ><br>follow study procedure. <br/ ><br>3. Woman with child bearing potential confirming use of primary <br/ ><br>contraception. <br/ ><br>4. Mild to moderate freshly confirmed COVID 19 positive report within 24-48 hours not requiring emergency or ICU care at the time of enrolment and are required to be admitted to the hospital (Dedicated Covid Health Centre) for treatment. <br/ ><br>→ | Exclusion criteria: 1. Severe COVID 19 positive subjects requiring ventilation or oxygen <br/ ><br>support when diagnosed. <br/ ><br>2. Females who are planning to conceive during the study duration or <br/ ><br>are pregnant already or are breastfeeding. <br/ ><br>3. Subjects having serious or unstable respiratory disorders (selfreported). <br/ ><br>4. Subject already on immune therapy (self-reported). <br/ ><br>5. History of Immunodeficiency or organ transplant (self-reported). <br/ ><br>6. Presence of Autoimmune disease (self-reported). <br/ ><br>7. Current acute infection or exacerbation of a chronic illness (selfreported). <br/ ><br>8. Cancer within last 5 years (self-reported). <br/ ><br>9. Known infection with HIV, Hepatitis B & Hepatitis C (self-reported) <br/ ><br>10. Drug abuse/alcohol abuse (self-reported). <br/ ><br>11. Patients with severe cardiac pathologies or any chronic illness or <br/ ><br>comorbid illness (self-reported). <br/ ><br>12. Patients on treatment for Diabetes Mellitus. <br/ ><br>13. Patients with the history of neurological or psychiatric illness (selfreported). <br/ ><br>14. Receiving blood or immunoglobulins within 3 months (selfreported). <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Mulmina mango drink plus standard of care treatment.: Mulmina mango is rich in antioxidants, vitamins, minerals and mesonutrients. Mulmina mango<br>contains extracts from mango, centella asiatica and turmeric.<br>Dosage: 2 Tetrapak Packs of 200 ml each per Day.<br>Control Intervention1: standard of care treatment: The standard of care treatment will be as prescribed by the treating<br>doctor as per the revised clinical management protocol for COVID-19 as issued by Govt of India,<br>MoHFW. <br>Dosage: As prescribed by the treating physician.<br>→ | 1. Faster Recovery: clinical symptoms and subjectâ??s critical state defined on 7-point ordinal scale. <br/ ><br>2. Stress: measured by DASS scale <br/ ><br>3. Mental Health: measured through a self-perception Hamilton Anxiety Scale <br/ ><br>4. General Well-being/Systemic Health: measured through a self perception WHO 5 wellbeing scale <br/ ><br>5. Happy Hormones (Dopamine and Serotonin <br/ ><br>6. IgG <br/ ><br>7. T-Lymphocyte Counts: CD4 T cells and CD8 T cells <br/ ><br>8. Anti-viral property: RT-PCR <br/ ><br>9. Antiallergic activity: IgE and CRP <br/ ><br>Timepoint: Enrollment -Discharge - plus 14 days of Follow up→ | | 21/10/2020 | | Yes | False | | |
| → | CTRI/2020/09/027560 | 27 January 2021 | Identifying homeopathy medicines in use for protection against
COVID-19, calculating the number of COVID-19 cases or cases with COVID-19 like symptoms in these homeopathy users and identifying some general features like age, gender and location in them. | Understanding usage of homeopathy medicines for prophylaxis against
COVID-19 and estimation of the incidence of COVID-19 or COVID-19 like symptoms in the
cohort of homeopathic users | | Dr Kalyan Banerjee Dr Kushal Banerjee | 02-09-2020 | 20200902 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47165 | Not Recruiting | No | | | | 15-09-2020 | 6500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Australia;Belgium;Canada;China;Germany;Hong Kong;India;Italy;Norway;Singapore;Sweden;Switzerland;Thailand;United Arab Emirates;United Kingdom;United States of America→ | Kushal Banerjee→ | | Dr. Kushal Banerjees Chamber, Dr. Kalyan Banerjees Clinic, I 1691 Chittaranjan Park → | kushal@drkbanerjee.com→ | | Dr. Kalyan Banerjees Clinic→ | Inclusion criteria: Individuals of all ages and both genders who have taken homeopathic medicines for prophylaxis against COVID-19→ | Exclusion criteria: Individuals who have not taken any homeoapthic medicines for prophyalxis against COVID-19→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Laboratory confirmation of COVID19 or COVID19 like symptomsTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/09/027558 | 27 January 2021 | Dental Students Health and Well being During Covid-19 Pandemic. | Impact of Lockdown imposed due to Coronavirus(COVID-19)Pandemic on the Health and Well being of Dental students in West Bengal | | Swet Nisha | 02-09-2020 | 20200902 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44917 | Not Recruiting | No | | | | 10-09-2020 | 480 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Arnab Ganguly→ | | All India Institute of Hygiene and Public health
block JC 27 and 27b sector III bidhannagar
Kolkata
all india institute of hygiene public health block JC 27 AND 27b sector III bidhannagar
Kolkata→ | drarnabgangulymd@gmail.com→ | 9051721216→ | All India Institute of Hygiene and Public health→ | Inclusion criteria: Dental Graduates <br/ ><br>Dental Postgraduates <br/ ><br>Interns <br/ ><br>studying at Haldia Institute of Dental Sciences And Research→ | Exclusion criteria: Rest→ | | Control Intervention1: NIL: NIL<br>→ | Qualitative data generated by In-depth interviewing and Free listing and Pile sortingTimepoint: Baseline data collection to 4 weeks for data analysis <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/09/027544 | 27 January 2021 | Covid 19 and Professional course students quality of life | Quality of life during COVID-19 pandemic among professional course students of selected colleges in and around Kolkata ,India. | | Swet Nisha | 02-09-2020 | 20200902 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47068 | Not Recruiting | No | | | | 10-09-2020 | 636 | Observational | Other<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Arnab Ganguly→ | | All India Institute Of Hygiene And Public Health,Department of Epidemiology ,room no.7.
Block JC 27 And 27b Sector III Bidhannagar Division
Kolkata
WEST BENGAL → | drarnabgangulymd@gmail.com→ | 9051721216→ | All India Institute of Hygiene and Public health→ | Inclusion criteria: Age more than 18 years <br/ ><br>Citizen of India <br/ ><br>Must be enrolled in any full time Undergraduate or postgraduate course→ | Exclusion criteria: Age less than 18 years <br/ ><br>Not Indian Citizen <br/ ><br>Discontinued studies or not enrolled in full time course.→ | | | Determination of Quality of Life of Professional Students during Covid-19 PandemicTimepoint: Baseline Data collection to 8 weeks time interval→ | | | | Yes | False | | |
| → | CTRI/2020/09/027562 | 27 January 2021 | Effect of prone positioning with HFNC on oxygenation and overall outcomes in severe COVID-19 patients. | Effect of prone positioning and high flow nasal cannula on oxygenation and overall outcome in spontaneously breathing awake patient with COVID-19 induced acute hypoxemic respiratory failure. | | Maulana Azad Medical College and Lok Nayak Hospital | 03-09-2020 | 20200903 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47154 | Not Recruiting | No | | | | 01-10-2020 | 92 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Deepak Kumar→ | | Department of Anaesthesiology
C-241 Albert square Mandir marg Department of Anaesthesiology
Maulana Azad Medical College
4th Floor room 401 BL Taneja block Bahadur Shah Zafar Marg
New Delhi→ | deepakkumar3090@gmail.com→ | 9717864257→ | Maulana Azad Medical College and Lok Nayak Hospital→ | Inclusion criteria: Patients with hypoxemic respiratory failure defined as respiratory rate â?¥20 breaths/min and oxyhemoglobin saturation (SpO2) <94% while receiving supplemental oxygen 6 L/min via nasal cannula or 15 L/min via non-rebreather facemask→ | Exclusion criteria: 1) Immediate need for intubation (PaO2/FiO2 < 50 mmHg, unable to protect airway or change of mental status) <br/ ><br>2) Unstable hemodynamic status <br/ ><br>3) Pregnant patients <br/ ><br>4) Morbidly obese <br/ ><br>5) Patient refusal to PP or any other contraindication to PP <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Prone Positioning along with High Flow Nasal Cannula: Effect of Prone Positioning along with High Flow Nasal Cannula on Oxygenation and overall outcomes in biochemical inflammatory markers along with mortality in COVID-19 pneuminia patients<br>→ | The number of patients requiring Non-invasive or invasive mechanical ventilationTimepoint: 1-2weeks→ | | | | Yes | False | | |
| → | CTRI/2020/09/027572 | 27 January 2021 | "Effect of comorbidities in the outcome of COVID-19 patients, a study in tertiary care centre ICU in Indiaâ?? | "Effect of systemic illness & comorbidities in the prognosis of COVID-19 patients, an observational study in tertiary care centre ICU in Indiaâ?? | | NIL | 03-09-2020 | 20200903 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46643 | Not Recruiting | No | | | | 14-09-2020 | 350 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Deepa Kerketta Khurana→ | | Dept of Anaesthesia
VMMC and Safdarjung Hospital
New Delhi
110029
India → | drdeepa.khurana@gmail.com→ | 9871813837→ | VMMC & Safdarjung Hospital→ | Inclusion criteria: <br/ ><br>a. Patient presenting to the COVID Suspect Zone ICU, ground floor. <br/ ><br>b. Patients with previous known or recently diagnosed Co-morbidities. <br/ ><br>c. Patients with no known Co morbidities will also be included. <br/ ><br>d. Patients with SARI requiring ICU admission. <br/ ><br>e. Patients of mild to moderate cases requiring oxygen therapy or ventilatory support in ICU . <br/ ><br>f. Patients with all requisite data available in records will only be included. <br/ ><br>→ | Exclusion criteria: a. Admissions not falling in the above-mentioned criteria. <br/ ><br>b. Patients who do not have complete lab data to assess the SOFA score. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To investigate the relationships between a known co-morbidity and the severity of disease in patients presenting with lab proven COVID 19. Timepoint: Data collected at the time of admission in ICU.→ | | | | Yes | False | | |
| → | CTRI/2020/09/027596 | 27 January 2021 | Behavioral changes during COVID 19 among cricket players in India | Psychosocial effects of the lockdown on cricket players in India â?? a qualitative web-based survey | | C Research Foundation | 04-09-2020 | 20200904 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47171 | Not Recruiting | No | | | | 14-09-2020 | 50 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr B Vinod Kumar→ | | C3 Research Foundation,
Research Department,
Sports Medicine Division,
Room No 2,
No 5/463, Valayapathi Salai, J.J.nagar, Mugappair East → | pulse@c3rf.com→ | | C3 Research Foundation→ | Inclusion criteria: 1. All professionally active cricket players <br/ ><br> <br/ ><br>2. Of collegiate, professional, or elite levels→ | Exclusion criteria: 1. Players outside the age criteria <br/ ><br> <br/ ><br>2. Recreational and players of levels lower than collegiate. <br/ ><br>→ | | | To understand the psychological and fitness related effects of the lockdown on cricket players in India and the efforts taken by the players to cope with those effectsTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/09/027597 | 27 January 2021 | Testing Saliva for SARS-CoV-2 | Assessment of swabs and saliva collected by patients for SARS-CoV-2 testing efficiency - SALIVA | | Asian Healthcare Foundation | 04-09-2020 | 20200904 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47024 | Not Recruiting | No | | | | 07-09-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | Dr M Sasikala→ | | Dept of Basic Sciences
Division of Molecular Biology
Facility block,6th floor
Plot No 2/3/4/5, Survey No 136/1 Mindspace Road, Gachibowli → | aigindia@yahoo.co.in→ | 04042444222→ | Asian Institute of Gastroenterology Hospitals→ | Inclusion criteria: 1.Patients with clinical symptoms such as fever, sore throat and cough and who have been admitted in the hospital and tested positive by RT-PCR <br/ ><br>2. Patients who can take swab by themselves <br/ ><br>3.Patients who can collect saliva <br/ ><br>4. Patients who can give informed consent <br/ ><br>→ | Exclusion criteria: 1.Patients with clinical symptoms of flu <br/ ><br>2.Patients who cannot take swabs by themselves <br/ ><br>3.Patients who cannot collect saliva <br/ ><br>4. Patients who can give informed consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | Simple method of sampling for testing SARS-CoV-2 infectionTimepoint: One month→ | | | | Yes | False | | |
| → | CTRI/2020/09/027616 | 27 January 2021 | Oral medicine trial for COVID 19 | A Single blind double Armed Clinical study in the management of COVID 19 through Shamanoushadi | | RGUHS Bangalore | 05-09-2020 | 20200905 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47155 | Not Recruiting | No | | | | 13-01-2021 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Case Record Numbers Blinding and masking:Participant Blinded | Phase 1 | India→ | Dr Prashant A S→ | | Professor and HOD, Dept. of Kayachikitsa, Ayurveda Mahavidyalaya, Heggeri Extension, HUBLI → | drprashanthas@gmail.com→ | 9448114773→ | Principal, Professor and HOD→ | Inclusion criteria: 1. Hospitalized <br/ ><br>2. Adults 18 year or older <br/ ><br>3. Moderately severe disease (NEWS score â?¤ 6) <br/ ><br>4. SARS-CoV-2 positive nasopharyngeal swab <br/ ><br>5. Signed informed consent must be obtained and documented according to ICH GCP, and national/local regulations. <br/ ><br>→ | Exclusion criteria: 1. Requiring ICU admission at screening <br/ ><br>2. Tinnitus, reduced hearing <br/ ><br>3. Visual impairment <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Dashanga gulika & Haridra Khanda: Dose : 2 gulika & 12gm <br>Dosage form : gulika and choorna with sukoshna jala <br>Route of Administration : Oral route <br>Time of Administration : Twice a day (empty stomach in the morning & evening) <br>Duration of therapy : 45 Days <br><br>Control Intervention1: Bharangi Dasahmula Kashaya & Karpooradi Choorna: Dose : 25ml & 12gm <br>Dosage form : Liquid and choorna<br>Route of Administration : Oral route <br>Time of Administration : Twice a day (empty stomach in the morning & evening) <br>Duration of therapy : 45 Days <br><br>→ | COVID 19 swab testTimepoint: On lst day, 15th day, 30th day and after 45 days.→ | | | | Yes | False | | |
| → | CTRI/2020/09/027615 | 27 January 2021 | Clinical trial of homeopathic medicine arsenic album as add on therapy in hospitalized patients admitted with Covid 19 disease. | â??Clinical trial to evaluate the efficacy of Homeopathic medicine Arsenicum album as add on therapy in treating hospitalized patients diagnosed with Covid 19.â?? | | Dr Vishal Narwane | 05-09-2020 | 20200905 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46648 | Not Recruiting | No | | | | 11-09-2020 | 200 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | N/A | India→ | Dr Vishal Harilal Narwane→ | | Mgm mcri hospital, mcri icu, 7th flore, N-6 cidco, Aurangabad. cidco n6 aurangabad 431003→ | nvishu007@yahoo.co.in→ | 9405292852→ | mgm mcri hospital and college→ | Inclusion criteria: 1) Subjects male or female age 18 to 75 years. <br/ ><br>2) Laboratory confirmed cases of sars-cov-2 positive <br/ ><br>3) Signs of respiratory failure requiring oxygen therapy <br/ ><br>4) Negative results for pregnancy <br/ ><br>5) Subjects or relatives are willing and capable of signing the consent. <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1) Autoimmune disease <br/ ><br>2) Subject under-vent major surgery <br/ ><br>3) Pregnant or lactating females <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Arsenicum album: Arsenicum album <br>Homeopathic medicine in <br>30x 200 and 1m potency (Doses as per Homeopathic Pharmacopia)<br>Control Intervention1: Standard line treatment for Covid 19: Antivirals like Remdesvir, Fabiflu<br>Antibiotics as monocef, piptaz, meropenem<br>Steroids like Methylprednisone, Hydrocortisone<br>Immunosupressants like tocilizumab<br>→ | Proportion of patients achieving viral clearance or symptoms free within 28 days, upon administration of treatment for 28 days in patients. <br/ ><br>1 by doing investigations of inflammatory markers <br/ ><br>2 weaning from ventilation <br/ ><br>3 weaning oxygen of patientsTimepoint: Assessment on daily basis, and investigatory assessment on 1st day, 4th day, 7th day, 11th day and on discharge.→ | | | | Yes | False | | |
| → | CTRI/2020/09/027613 | 27 January 2021 | Pattern of acute MI admissions in India during COVID-19 era: a Cardiological Society of India study
| Pattern of acute MI admissions in India during COVID-19 era: a Cardiological Society of India study
| | Cardiological Society of India | 05-09-2020 | 20200905 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46158 | Not Recruiting | No | | | | 15-09-2020 | 30000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Geevar Zachariah→ | | PO N Pullazhi Rd Olarikkara Thrissur, Kerala PANTHEON, REMADEVI MANDIR LANE
PUNKUNNAM THRISSUR 680002→ | geevarzachariah@gmail.com→ | 914872380022→ | Chairman, Mother Heart Care→ | Inclusion criteria: Acute Myocardial infraction→ | Exclusion criteria: Any admissions other than for MI→ | Health Condition 1: PCS-
→ | | To find out change in the number of AMI admissions in major hospitals in India during the period from 15th of March to 15th of June 2020 (COVID-19 era) compared to corresponding period in 2019. And to find out weekly AMI admissions during the period from 15th of March to 15th of June 2020, in different parts of India and to assess the impact of various phases of lockdown and its relaxations in AMI admissions.Timepoint: The period from 15th of March <br/ ><br>to 15th of June 2020 (COVID-19 era) compared to corresponding period in 2019.→ | | | | Yes | False | | |
| → | CTRI/2020/09/027617 | 27 January 2021 | Effect of COVID-19 positivity on pregnancy characteristics and pregnancy on infectivity potential of COVID-19 | Effect of COVID-19 positivity on pregnancy characteristics and pregnancy on infectivity potential of SARS-CoV-2: An observational study | | All India Institute of Medical Sciences Rishikesh | 05-09-2020 | 20200905 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47239 | Not Recruiting | No | | | | 14-09-2020 | 50 | Observational | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Kavita Khoiwal→ | | Department of obstetrics and gynaecology → | kavita.kh27@gmail.com→ | 9690396908→ | AIIMS Rishikesh→ | Inclusion criteria: All pregnant females of any gestational age with COVID-19 disease. <br/ ><br>Non pregnant females of reproductive age group with COVID-19 disease. <br/ ><br>Low risk pregnant females without COVID-19 disease.→ | Exclusion criteria: Patients denied to comply with the study protocol→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Control Intervention1: Observation of pregnancy characteristics and severity of disease: The data of Covid positive pregnant women will be compared with Covid negative low risk pregnant women to determine effect of Covid disease on pregnancy outcomes. It will also be compared with Covid positive non pregnant women of reproductive age group to assess the severity of Covid disease in both the groups i.e. effect of pregnancy on severity of Covid disease.<br>→ | Frequency of adverse maternal and fetal outcomes in pregnancies affected by COVID-19 in terms of early pregnancy loss, preterm labour, fetal growth restriction or fetal infection with SARS-CoV-2.Timepoint: 2 years→ | | | | Yes | False | | |
| → | CTRI/2020/09/027618 | 27 January 2021 | Identification of SARS-CoV-2 in female genital tract and breast milk in confirmed cases of COVID-19 | Identification of SARS-CoV-2 in female genital tract and breast milk in confirmed cases of COVID-19: A hospital based cross sectional study | | All India Institute of Medical Sciences Rishikesh | 05-09-2020 | 20200905 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47248 | Not Recruiting | No | | | | 14-09-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Kavita Khoiwal→ | | Department of Obstetrics and Gynaecology → | kavita.kh27@gmail.com→ | 9690396908→ | All India Institute of Medical Sciences Rishikesh→ | Inclusion criteria: All reproductive age group women > 18 years old, sexually active and postmenopausal women with confirmed Covid-19 infection either by nasopharyngeal swab RT-PCR or standard Q Covid-19 Antigen test. <br/ ><br>All eligible women who are willing to participate in the study.→ | Exclusion criteria: Women with negative Nasopharyngeal swab RT-PCR or standard Q Covid-19 Antigen test for SARSCoV-2. <br/ ><br>Terminally ill patients (unconscious and ventilated patients)→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B349- Viral infection, unspecified
→ | Control Intervention1: Nil: Nil<br>→ | 1 Proportion of vaginal fluid and cervical exfoliated cellsâ?? samples positive for SARS-CoV-2 in confirmed cases of COVID-19. <br/ ><br>2 roportion of amniotic fluid, cord blood, placenta and placental membranes, and breast milk samples positive for SARS-CoV-2 in confirmed cases of COVID-19 positive mothers.Timepoint: 1 year→ | | | | Yes | False | | |
| → | CTRI/2020/09/027614 | 27 January 2021 | Effectiveness of training programme on hand hygiene among laundry staff | Effectiveness of a training programme on Knowledge, Attitude and Practice (KAP) of hand hygiene among laundry staff of tertiary care hospital in North Kerala treating COVID 19 patients | | Nil | 05-09-2020 | 20200905 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46274 | Not Recruiting | No | | | | 24-08-2020 | 14 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Binoo Divakaran→ | | Dept. of Community Medicine, Government Medical College, Pariyaram, Kannur, Kerala, India. → | binoovimal@gmail.com→ | 09447103616→ | Government Medical College Kannur→ | Inclusion criteria: All laundry staff who can read write and understand Malayalam→ | Exclusion criteria: Those who are not willing to participate→ | | | Effectiveness of training programmeTimepoint: Two times data will be collected, there will be a gap of one week between these two time points→ | | | | Yes | False | | |
| → | CTRI/2020/09/027622 | 27 January 2021 | Role of female sex hormone in COVID 19 patients | Role of short term oral oestradiol in natural oestrogen deficient symptomatic COVID-19 patients-a Randomized Control Study | | Dr Shikha seth | 07-09-2020 | 20200907 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46908 | Recruiting | No | | | | 08-09-2020 | 64 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Shikha Seth→ | | Room no 3 OPD block ground floor department of obstetrics and gynaecology
Government institute of medical sciences greater Noida UP → | drsethrims@gmail.com→ | 9411850238→ | Government institute of medical sciences greater Noida UP→ | Inclusion criteria: 1.Documented symptomatic(fever of 100.5°F or more or 38°C shortness of breath cough anosmia GI disturbances persisting myalgiaetc any one of them present).) COVID19 positive patients. <br/ ><br>2.Male 18-60 years of age <br/ ><br>3.Female 40-60 years of age with one year amenorrhoea. <br/ ><br>4.Ready to participate and provide informed consent. <br/ ><br>5.Patients enrolled shall not be the part of any other drug trial. <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1.Currently receiving estrogen based hormonal therapy <br/ ><br>2.Abnormal genital bleeding <br/ ><br>3.Subjects with known past diagnosis of estrogen receptor positive breast cancer or endometrial cancer <br/ ><br>4.Pre-existing liver impairment (e.g. Hepatitis C, cirrhosis),heart disease, Any history of thromboembolic event including deep vein thrombosis or pulmonary emboli , History of stroke. <br/ ><br>5.Receiving anti epileptic therapy <br/ ><br>6.Subjects with severe COVID disease. <br/ ><br>7.Males on testosterone <br/ ><br>8.Those on steroids for any of their disease <br/ ><br>9.Patients enrolled in any other drug trial. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Estradiol valerate, standard care: Study group will receive Estradiol Valerate orally 2 mg once a day for 7 days along with standard care as an adjunctive therapy.<br>Control group will receive only standard care.<br><br><br>Control Intervention1: Standard care: Control group will receive only standard care.<br>→ | Total hospital stay durationTimepoint: number of days→ | | | | Yes | False | | |
| → | CTRI/2020/09/027661 | 27 January 2021 | Preventive Study among COVID 19 frontline warriors and their families | A prospective non-randomized open label interventional study on the effect of AYURAKSHA Immuno boosting Kit as a prophylactic measure among frontline COVID warriors and their family members | | Central Ayurveda Research Institute for Hepatobiliary Disorders | 08-09-2020 | 20200908 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47273 | Not Recruiting | No | | | | 15-09-2020 | 3000 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | Dr Krishna Rao S→ | | Central Ayurveda Research Institute for Hepatobiliary Disorders, Bhubaneswar
Technical Section
Room no 52 → | krdrkrishnarao@gmail.com→ | | CCRAS,Under AYUSH→ | Inclusion criteria: Male or female participants above the age of 18 years to 70 years <br/ ><br>Police Officers, Media personnel, Health care workers; Sanitization workers, and their family members <br/ ><br>Participants who are ready to provide written/digital informed consent and who are willing to participate and follow the protocol requirements of the clinical study <br/ ><br> <br/ ><br>→ | Exclusion criteria: Known cases Covid-19. <br/ ><br>Pregnant and Lactating females <br/ ><br>Known cases of uncontrolled Diabetes and Hypertension <br/ ><br>Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>Participants having immune compromised status like HIV, Hepatitis, Tuberculosis, Cancer etc. <br/ ><br>Participants taking Steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>Participants participating in any other clinical study or having participated in any other study 1 month prior to screening in the present study. <br/ ><br>Participants having a history of allergy to any medicine that is part of the Ayurvedic intervention. <br/ ><br>Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol <br/ ><br>→ | | Intervention1: Ayuraksha Immunoboosting Kit: Chyavanprash (180gm) -1 teaspoon Once a day<br>AYUSH Kwath (100mg) - 3 gm boiled in 150ml water filtered and consumed<br>Samsamani vati (30gm) -2 tab bd with warm water<br>Anu taila (10ml)x2 <br>1 Drop nasal application twice a day <br><br>Control Intervention1: Nil: Nil<br>→ | Assessment of occurrence of COVID-19 infection in frontline COVID warriors and their family membersTimepoint: Assessment Done at Baseline(Day 0) and at Day 30→ | | | | Yes | False | | |
| → | CTRI/2020/09/027674 | 27 January 2021 | A Phase 1, Followed by a Phase 2, vaccine given Randomly in subjects in different sites
to Evaluate the Safety, side effects, and resistance of the Virus Vaccine, BBV152D Administered between the layers of the skin(intradermal) in Healthy Volunteers. | An Adaptive, Seamless Phase 1, Followed by a Phase 2, Randomized, Multicenter Study
to Evaluate the Safety, Reactogenicity, and Immunogenicity of the Whole Virion Inactivated SARS-CoV-
2 Virus Vaccine, BBV152D Administered Intradermally in Healthy Volunteers. - COVID ID STUDY | | Bharat Biotech International limited | 08-09-2020 | 20200908 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46312 | Recruiting | No | | | | 08-09-2020 | 124 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | Phase 1/ Phase 2 | India→ | Dr Krishna Mohan→ | | Bharat Biotech International Ltd, Medical Affairs Department, Genome Valley, Shameerpet, → | kmohan@bharatbiotech.com→ | 04023480567→ | Bharat Biotech International limited→ | Inclusion criteria: 1. Ability to provide written informed consent. <br/ ><br>2. Participants of either gender age between â?¥18 to â?¤55 years. (Phase 1) <br/ ><br>3. Participants of either gender age between â?¥12 to â?¤65 years. (Phase2) <br/ ><br>4. Good general health as determined by the discretion of investigator (vital signs <br/ ><br>(Pulse rate â?¥60 toâ?¤100 bpm; blood pressure systolic â?¥90 mm Hg and <140 mm <br/ ><br>Hg; diastolic â?¥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), <br/ ><br>medical history, and physical examination). <br/ ><br>5. Expressed interest and availability to fulfil the study requirements. <br/ ><br>6. For a female participant of child-bearing potential, avoid becoming pregnant <br/ ><br>(use of an effective method of contraception or abstinence) from the time of <br/ ><br>study enrolment until at least 4 weeks after the last vaccination and agrees not <br/ ><br>to participate in another clinical trial at any time during the study period. <br/ ><br>7. Sexually active men who are considered sexually fertile must agree to use a <br/ ><br>barrier method of contraception and agree to continue the use for at least 3 <br/ ><br>months following the last vaccination, or have a partner who is permanently <br/ ><br>sterile or is medically unable to become pregnant. <br/ ><br>8. Male subjects agree to refrain from sperm donation from the time of first <br/ ><br>vaccination until 3 months after last vaccination. <br/ ><br>9. Participants must refrain from blood or plasma donation from the time of first <br/ ><br>vaccination until 3 months after last vaccination. <br/ ><br>10. Agrees to remain in the study area for the entire duration of the study. <br/ ><br>11. Willing to allow storage and future use of biological samples for future <br/ ><br>research. <br/ ><br>→ | Exclusion criteria: 1. History of any other COVID-19 investigational vaccination. <br/ ><br>2. Unacceptable laboratory abnormality from screening (before first vaccination) <br/ ><br>or safety testing as listed below. <br/ ><br>ï?? Hematology, Random blood sugar , Renal function test (Blood urea nitrogen <br/ ><br>(BUN) and Serum creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C, HIV antibody, and hepatitis B surface antigen. (Subjects will <br/ ><br>be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody and <br/ ><br>hepatitis B surface antigen (HBsAg) and will be referred to a primary care provider for <br/ ><br>follow up of these abnormal laboratory tests.) <br/ ><br>3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA. <br/ ><br>4. Pregnancy, lactation or willingness/intention to become pregnant during the <br/ ><br>study <br/ ><br>5. Temperature > 38.0°C (100.4°F) or symptoms of an acute self-limited illness <br/ ><br>such as an upper respiratory infection or gastroenteritis within 3 days before <br/ ><br>each dose of vaccine. <br/ ><br>6. Medical, problems as a result of alcohol or illicit drug use during the past 12 <br/ ><br>months. <br/ ><br>7. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days <br/ ><br>before enrolment or expects to receive an experimental agent during the study <br/ ><br>period. <br/ ><br>8. Known sensitivity to any ingredient of the study vaccines, or a more severe <br/ ><br>allergic reaction and history of allergies or anaphylaxis concerning vaccination <br/ ><br>in the past. <br/ ><br>9. Receipt of immunoglobulin or other blood products or blood transfusions <br/ ><br>within the 3 months before vaccination in this study. <br/ ><br>10. Either Immunosuppressant or Immunocompromised status, as a result of an <br/ ><br>underlying illness or treatment with immunosuppressive or cytotoxic drugs, or <br/ ><br>use of anticancer chemotherapy or radiation therapy within the preceding 36 <br/ ><br>months. <br/ ><br>11. Long-term use ( > 2 weeks) of oral or parenteral steroids (glucocorticoids), or <br/ ><br>high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or <br/ ><br>equivalent) within the preceding 6 months (nasal and topical steroids are <br/ ><br>allowed). <br/ ><br>12. Any history of hereditary angioedema or idiopathic angioedema. <br/ ><br>13. History of any cancer. <br/ ><br>14. History of serious psychiatric conditions likely to affect participation in the <br/ ><br>study. <br/ ><br>15. A bleeding disorder (e.g. factor deficiency, coagulopathy, or platelet disorder), <br/ ><br>or prior history of significant bleeding following venipuncture. <br/ ><br>16. Any other serious chronic illness requiring hospital specialist supervision. <br/ ><br>17. Chronic respiratory diseases (SARS), including mild asthma <br/ ><br>18. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal <br/ ><br>disease, an endocrine disorder, and neurological illness <br/ ><br>19. Morbidly Obese (BMIâ?¥35 kg/m2) or underweight (BMI â?¤18 kg/m2). <br/ ><br>20. Living in the same household of any COVID-19 positive. <br/ ><br>21. New onset of fever or a cough or shortness of breath or anosmia/ageusia since <br/ ><br>May 2020. Should a reliable test become available, these exclusion criteria will <br/ ><br>be replaced with seropositivity for COVID-19 before enrolment. <br/ ><br>22. Any other condition that in the opinion of the investigator would jeopardize the <br/ ><br>safety or rights of a volunteer participating in the trial or would render th→ | | Intervention1: BBV152D: Dose :2 x 0.1 mL for arm 2 at day 0 and 14. Route of administration:Intradermal injection, Frequency:Two doses at Day 0 and Day 14<br>Intervention2: BBV152D: Whole Virion Inactivated SARS-CoV-2 vaccine (BBV152D) dose:0.1 ml route of administration:<br>intradermally , 1 x 0.1 mL for Arm 1 frequency:day 0 and 14.<br>→ | Phase 1 <br/ ><br>1. The occurrence of immediate adverse events within two hours of vaccination. <br/ ><br>2. The occurrence of adverse events within seven days . <br/ ><br>3. The occurrence of any adverse events throughout the study duration <br/ ><br> 4. The occurrence of serious adverse events (SAEs). <br/ ><br> <br/ ><br>Phase 2 <br/ ><br>1. To evaluate the immunogenicity in terms of four-fold seroconversion rate of SARSCoV- <br/ ><br>2 virus neutralizing antibodies across the two dosage strengths of BBV152D.Timepoint: Phase 1 <br/ ><br> <br/ ><br>1.Time Frame: 2 hours. <br/ ><br>2.Time Frame: 7 <br/ ><br>days <br/ ><br>3. Time Frame: throughout the study duration <br/ ><br>4.Time Frame: throughout the <br/ ><br>study duration. <br/ ><br> <br/ ><br>Phase 2 <br/ ><br>baseline to day 0, 14, 28, 42, 104 and 194.→ | | | | Yes | False | | |
| → | CTRI/2020/09/027684 | 27 January 2021 | Protective effect of re-vaccination with
BCG against COVID-19 in healthcare workers â?? A Pilot Study
| Protective effect of re-vaccination with
BCG against COVID-19 in healthcare workers â?? A Pilot Study
| | SGT University | 09-09-2020 | 20200909 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47179 | Recruiting | No | | | | 15-09-2020 | 400 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Dr Dharampal Singh Sudan→ | | Department Of Pulmonary Medicine
SGT Hospital Medical College and Research Institute
SGT University
Budhera
Gurugram
→ | hod.tbchest@sgtuniversity.org→ | 9888603012→ | SGT Hospital Medical College & Research Institute→ | Inclusion criteria: 1.Health care workers including doctors, nursing staff, para â?? medical staff and sanitation workers who shall be going for the COVID-19 isolation ward duty. <br/ ><br>2.Female healthcare workers who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 3 months post-revaccination with BCG. <br/ ><br>3.The participants must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form <br/ ><br>→ | Exclusion criteria: 1.Pregnant and / or lactating female healthcare workers. <br/ ><br>2.A family history of congenital or hereditary immunodeficiency. <br/ ><br>3.History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator. <br/ ><br>4.History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study.. <br/ ><br>5.Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patientâ??s health or is likely to result in nonconformance to the protocol or a patientâ??s ability to give written informed consent. <br/ ><br> <br/ ><br>→ | | Intervention1: BCG Vaccine: 0.1 ml reconstituted BCG vaccine administered intra-dermally single dose to be given one week prior to COVID-19 isolation ward duty<br>Control Intervention1: BCG Re-vaccination: Rate of infection of COVID-19 in healthcare workers given BCG revaccination as compared to controls<br>→ | 1.Rate of infection of COVID-19 in healthcare workers re- <br/ ><br>vaccinated with BCG as compared to controls <br/ ><br>2.Change in the CD4+ T- cell count and CD8+T- <br/ ><br>cell count â?? before vaccination and after 6 weeks. <br/ ><br>3.Severity of COVID-19 infection in Healthcare workers revaccinated with BCG as compared to controls. <br/ ><br> <br/ ><br>Timepoint: At 6 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/09/027680 | 27 January 2021 | Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID) | Phase 3 randomized, double-blind, placebo-controlled, multi-center study to assess the efficacy and safety of ruxolitinib in patients with COVID-19 associated cytokine storm (RUXCOVID) | | Novartis Healthcare Pvt Ltd | 09-09-2020 | 20200909 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46451 | Not Recruiting | No | | | | 20-09-2020 | 402 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 3 | Argentina;Brazil;Canada;Colombia;France;Germany;India;Italy;Mexico;Panama;Peru;Russian Federation;South Africa;Spain;Turkey;United Kingdom;United States of America→ | Murugananthan K→ | | Novartis Healthcare Pvt Ltd GDO Trial Monitoring, India 6 & 7 floor ,
Inspire BKC G Block, BKC Main Road Bandra Kurla Complex
Bandra (East) Mumbai
→ | murugananthan.k@novartis.com→ | | Novartis Healthcare PVT LTD→ | Inclusion criteria: 1-Patient or guardian/health proxy must provide informed consent (and assent if applicable) before any study assessment is performed. <br/ ><br>2-Male and female patients aged â?¥ 12 years (or â?¥ the lower age limit allowed by Health Authority and/or Ethics Committee/Institutional <br/ ><br> Review Board approvals). <br/ ><br>3-Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test from the respiratory tract prior to randomization. <br/ ><br>4-Patients currently hospitalized or will be hospitalized prior <br/ ><br> to randomization. <br/ ><br>5-Patients, who meet at least one of the below criteria: <br/ ><br>Pulmonary infiltrates (chest X ray or chest CT scan); Respiratory frequency â?¥ 30/min; Requiring supplemental oxygen; Oxygen saturation â?¤ 94% on room air;→ | Exclusion criteria: History of hypersensitivity to any drugs or metabolites of similar chemical classes as ruxolitinib.Presence of severely impaired renal function defined by serum creatinine > 2 mg/dL ( >176.8 μmol/L), or have estimated creatinine clearance < 30 ml/min measured <br/ ><br> or calculated by Cockroft Gault equation or calculated by the updated bedside Schwartz equation.Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).Currently intubated or intubated between screening and randomization. In <br/ ><br> intensive care unit (ICU) at time of randomization. Intubated or in ICU for COVID-19 disease prior to screening. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).Unable <br/ ><br> to ingest tablets at randomization. Pregnant or nursing (lactating) womenOther protocol-defined inclusion/exclusion criteria may apply.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Drug: Ruxolitinib: Ruxolitinib 5 mg tablets twice daily (b.i.d.) for 14 days with possible extension of treatment to 28 days<br>Intervention2: Drug: Placebo: Matching-image placebo<br>Control Intervention1: Placebo Comparator: Placebo: Matching-image placebo for 14 days with possible extension of treatment to 28 days<br>Control Intervention2: Placebo: Matching-image placebo<br>→ | Proportion of patients who die, develop respiratory failure [require mechanical <br/ ><br> ventilation] or require intensive care unit (ICU) care <br/ ><br>Efficacy is measured by a composite endpoint of proportion of patients who die, develop respiratory failure [require mechanical ventilation], or require intensive care unit [ICU] care for the treatment of COVID-19.Timepoint: Time Frame: 29 days→ | | | | Yes | False | | |
| → | CTRI/2020/09/027681 | 27 January 2021 | Determining The Best Time For Surgery After COVID-19 Infection | Global Surg-Covid Surg Week: Determining The Optimal Timing For Surgery Following SARS-CoV-2 Infection - CovidSurg Week | | University Of Birmingham | 09-09-2020 | 20200909 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46744 | Recruiting | No | | | | 01-10-2020 | 45000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Algeria;Argentina;Australia;Austria;Bahrain;Bangladesh;Belgium;Benin;Brazil;Bulgaria;Cameroon;Canada;Colombia;Denmark;Ecuador;Egypt;Estonia;Finland;Georgia;Germany;Ghana;Greece;Guatemala;Hungary;India;Indonesia;Iraq;Ireland;Italy;Japan;Jordan;Kenya;Kuwait;Malawi;Mali;Mexico;Montenegro;Morocco;Mozambique;Namibia;Nepal;New Zealand;Nicaragua;Nigeria;Norway;Oman;Pakistan;Panama;Paraguay;Peru;Philippines;Poland;Portugal;Qatar;Republic of Korea;Romania;Rwanda;Samoa;Saudi Arabia;Senegal;Singapore;Somalia;South Africa;Spain;Sweden;Turkey;United Arab Emirates;United Kingdom;United States of America;Uruguay;Venezuela (Bolivarian Republic of);Zambia→ | Pranay Pawar→ | | Department Of Surgery
Brown Road → | pranay.pawar@cmcludhiana.in→ | 9780300142→ | Christian Medical College→ | Inclusion criteria: Any operation (elective or emergency) done in an operating theatre by a surgeon, excluding minor procedures previously defined by Abbott TEF, Fowler AJ, Dobbs TD, Harrison EM, Gillies MA, Pearse RM. Frequency of surgical treatment and related hospital procedures in the UK: a national ecological study using hospital episode statistics. Br J Anaesth. 2017;119(2):249-257. <br/ ><br>All surgical specialties including: acute care surgery, breast surgery, cardiac surgery, colorectal surgery, general surgery, gynaecology, hepatobiliary surgery, neurosurgery, obstetrics, oesophagogastric surgery, ophthalmology, oral and maxillofacial surgery, orthopaedics, otolaryngology, paediatric surgery, plastic surgery, thoracic surgery, trauma surgery, urology, vascular surgery. <br/ ><br>Day case surgery and inpatient surgery included. <br/ ><br>Any SARS-CoV-2 status (positive at any time, negative, not tested). <br/ ><br>All ages including children and adults. <br/ ><br>→ | Exclusion criteria: All procedures not done in the operating room <br/ ><br>All Endovascular procedures <br/ ><br>All Interventional radiology procedures→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Pre-Operative Diagnosis of SARS-CoV-2: The intervention group includes patients with a diagnosis of SARS-CoV-2 at any time before surgery.<br>This includes patients diagnosed at any time before surgery (diagnosis could be days to months before surgery)<br>This includes patients who (1) were never symptomatic, (2) symptomatic at the time of diagnosis, but whose symptoms have now resolved (patient is not symptomatic on the day of surgery), (3) have ongoing symptoms of SARS-CoV-2 infection.<br>This group will be stratified by time since diagnosis (if known), severity of initial SARS-CoV-2 infection, and whether they are symptomatic at the time of surgery.<br><br>Intervention2: Nil: Observational Study<br>Control Intervention1: Postoperative SARS-CoV-2: Patients who were diagnosed with SARS-CoV-2 postoperatively within 30 days after surgery (this includes both patients who do and do not have symptoms).<br>Control Intervention2: Non-SARS-CoV-2: Patients who have not had a diagnosis of SARS-CoV-2 before surgery or within 30 days after surgery.<br>Control Intervention3: Nil: Observational Study<br>→ | 30 day post-operative mortalityTimepoint: 30 day post-operative mortality→ | | | | Yes | False | | |
| → | CTRI/2020/09/027687 | 27 January 2021 | Assessment of effect of steam inhalation, saline gargling and povidone Iodine gargling on reduction of symptoms and prevention of spread of COVID 19 | â??Impact of steam inhalation, saline gargling and povidone Iodine gargling on clinical outcome of COVID-19 patients under home isolation in Bengaluru, Karnataka â?? a Randomised Control Trialâ??â?? (SISPIG study) - SISPIG | | Dr Shobha | 09-09-2020 | 20200909 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47280 | Not Recruiting | No | | | | 16-09-2020 | 80 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Dr shobha→ | | Department of community medicine bengaluru → | shobha_bhushan@yahoo.co.in→ | 9449637523→ | Bangalore medical college and Research institute→ | Inclusion criteria: I. All patients with age more than 18 years who are asymptomatic,mild cases of COVID-19 who are under home isolation <br/ ><br>II. COVID-19 positive cases under home isolation who consents for the study <br/ ><br>III. Household contacts of home isolated COVID-19 patients who are able to understand and follow/perform the interventions. <br/ ><br>→ | Exclusion criteria: i. Patients with known history of immuno-suppressive disorders <br/ ><br>ii. Patients with known history of hyperthyroidism and other thyroid diseases and with symptoms suggestive of thyroid dysfunction like tremors, palpitation, heat/cold intolerance, lethargy, menstrual irregularities etc <br/ ><br>iii. Pregnant and lactating women <br/ ><br>iv. Patients with nasal polyps, recurrent nasal bleeding <br/ ><br>v. Patients with known allergy to iodine and its compounds and on Lithium therapy <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | Intervention1: Steam inhalation,saline gargling,povidine iodine gargling,one more is control group for whom no intervention is applied: 1. Saline gargling: Hypertonic saline solution is prepared by adding 3 grams of salt to 100ml of lukewarm water. Gargle with approximately 20 mL of hypertonic saline for about 15 seconds three times consecutively, and this has to be carried out at least three times a day everyday till patient gets released from home isolation. Gargle the salt water around the back of the throat. Rinse around the mouth, teeth, and gums. Spit out the solution.14<br>2. Povidone Iodine gargling: 9ml of 2% Povidone Iodine gargle solution will be mixed with 27 ml of lukewarm water (to get 0.5% w/v Povidone Iodine. Care will be taken to ensure that the solution is distributed throughout the oral cavity for 30 seconds and then gently gargled or held at the back of the throat for another 30 seconds before spitting out. This will be repeated three times a day everyday till patient gets released from home isolation.15<br>3. Steam inhalation Subjects will be instructed to fill water till the maximum level in the container of the electronic, automated steam inhalers provided and plug it into a power plug. The procedure for steam inhalation will be explained to the subjects as: â??Place your head just above the opening of the steam inhaler and cover your head with a towel in such a way that the sides are totally closed and you form a tent over the inhaler. Keep your eyes shut and breathe deeply through your nose. If you feel that the treatment is getting too much for you, raise the towel so that the fresh air is brought into the area and breathe through your mouth a couple of times and then resume your treatment. Continue the treatment for 3 to 5 minutes (effective exposur→ | 1) Reduction in severity of symptoms (VAS, temperature etc) in mild cases <br/ ><br>2) Early negativity of the RT PCR in nasopharyngeal swab among the intervention group when compared to the controls <br/ ><br>3) Reduction in transmission of infection among household members of COVID-19 patient <br/ ><br>Timepoint: 1) Baseline assessment and daily follow up of symptoms till 21 days <br/ ><br>2) Baseline swab test and swab test once every 3 days till two successive tests are negative <br/ ><br>3) Baseline symptomatic assessment of contacts and daily follow up of evolution of symptoms till 21 days and one swab test between 5th to 10th days of contact to assess transmission pattern. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/09/027683 | 27 January 2021 | Online survey on Dry eye symptoms in health care workers and children during COVID 19 pandemic | Online survey on Dry eye symptoms in health care workers and children in a pediatric tertiary care hospital during COVID 19 pandemic | | Dr Meenakshi wadhwani | 09-09-2020 | 20200909 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47026 | Not Recruiting | No | | | | 15-09-2020 | 330 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Meenakshi Wadhwani→ | | Room No 228, second floor,
Chacha Nehru Bal Chikitsalya, Geeta colony
New Delhi Room No 228, second floor,
Chacha Nehru Bal Chikitsalya, Geeta colony
New Delhi→ | mkgang08@gmail.com→ | 9211543453→ | MS ophthalmology→ | Inclusion criteria: All the health care workers Doctors nursing staff comma technician between 20- 60 years involved in laboratory duties OT technician after taking online consent in english <br/ ><br>Similarly parents aged 25-45 years of children between age group of 6-16 years attending regular school understanding English and having access to android phones computers comma labtops will be interviewed on questionnaires after taking online consent in EnglishThe children upto 12 years will be studied in CNBC and above 12 years will be sent this online google form through social media like whats app and emails <br/ ><br>→ | Exclusion criteria: → | | | Primary objective: To determine the incidence and percentage of health care workers and children developing dry eye symptoms like blurring of vision headache and watering due to increased screen time during lockdown period in COVID 19 pandemicTimepoint: July to september 2020→ | | | | Yes | False | | |
| → | CTRI/2020/09/027685 | 27 January 2021 | Clinical Study to Investigate Safety and Efficacy of ImmunoSEB and ProbioSEB | A Randomized, Open Label,2 Arm, Prospective Study to Investigate the Safety and Efficacy of the Health Supplements ImmunoSEB+ ProbioSEB CSC3 as Supplemental therapy in Confirmed Mild to Moderate COVID-19 Patients. | | Chirayu Medical College and Hospital | 09-09-2020 | 20200909 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47321 | Not Recruiting | No | | | | 16-09-2020 | 40 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Dr Rohit Parate→ | | Department of Medicine, Ground Floor, Chirayu Medical College and Hospital, Bhopal Indore Highway, near Bairagarh, Bhopal → | rohitparate963@gmail.com→ | 9630033342→ | Chirayu Medical College and Hospital→ | Inclusion criteria: 1.Patient who provides written informed consent <br/ ><br>2.Male or non-pregnant, non-lactating female aged 18 to 75 years (both inclusive) <br/ ><br>3.RT-PCR confirmed diagnosis of COVID-19 <br/ ><br>4.Able to take the drug orally and comply with study procedures <br/ ><br>5.Women of childbearing potential must have a negative urine pregnancy test prior to study entry→ | Exclusion criteria: 1. Severe Type <br/ ><br>Respiratory distress, RR >30 times/min <br/ ><br>Finger oxygen saturation <93% in rest state <br/ ><br>Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation FiO2 >300mmHg <br/ ><br>2. Critical type: meeting any of the following criteria <br/ ><br>Respiratory failure occurs and mechanical ventilation is required <br/ ><br>Patients go into shock <br/ ><br>ICU is needed for other organ failure. <br/ ><br>3.Patients who have received tumor immunotherapy such as <br/ ><br>PD-1/L1 CTLA4 etc. in the past 1 month, and inflammatory factor modulators such as Ulinastatin. <br/ ><br>4.other viral pneumonia <br/ ><br>5.patients who have received tumor immunotherapy in the past one <br/ ><br>month and inflammatory factor modulators such as Ulinastatin <br/ ><br>6. patients who have received organ transplantation or surgery <br/ ><br>planning in the past 6 months <br/ ><br>7. patients who cant take food or drugs due to coma or intestinal obstruction <br/ ><br>8.Patients who have severe underlying diseases that affects survival,including uncontrolled malignant tumor with multiple metastases that <br/ ><br>cannot be resected, blood diseases, dyscrasia, active bleeding,severe malnutrition, etc <br/ ><br>9.Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period <br/ ><br>10.Allergic to systemic enzyme supplements <br/ ><br>11.Patients whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper <br/ ><br>limit of normal, or patients with child-Pugh grade C cirrhosis <br/ ><br>12.ECLS (ECMO, ECCO2R, RRT) <br/ ><br>13.Imminent death in the opinion of the clinical team <br/ ><br>14.Patients who have participated in any other clinical study within 2 weeks prior to randomization <br/ ><br>15.The investigator concludes that the patient is not suitable for the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ImmunoSEB plus ProbioSEB<br>CSC3: ImmunoSEB Capsule / 500 mg<br>2 capsule bid and ProbioSEB<br>CSC3 Capsule / 5 billion CFUs<br>2 Capsule OD for 14 day.<br>Control Intervention1: Standard Care: standard care given as per<br>institutional practice.<br>→ | Proportion of patients showing clinical improvement.Timepoint: Proportion of patients showing clinical improvement at Day 14→ | | | | Yes | False | | |
| → | CTRI/2020/09/027686 | 27 January 2021 | To determine whether diabetes in COVID-19 patients is associated with more complications. | Outcome of Diabetes patients in COVID-19 | | GCS Hospital Medical College and Research Centre | 09-09-2020 | 20200909 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47332 | Not Recruiting | No | | | | 20-09-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Shams Kanuga→ | | Department of General Medicine, GCS Hospital, Medical College
and Research Centre, opposite DRM Office, near Chamunda Bridge,
Naroda Road, Ahmedabad → | shamskanuga293@gmail.com→ | 9429331221→ | | Inclusion criteria: COVID-19 positive patients and Newly detected or known case of diabetes. <br/ ><br>Non-diabetic patients will be taken as control group→ | Exclusion criteria: age less than 18 years. <br/ ><br>COVID-19 negative patients.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: E11- Type 2 diabetes mellitus
→ | | Outcome of COVID-19 patients with diabetes compared to non-diabetic patients in terms of mortality, complications and length of hospital stay.Timepoint: At baseline→ | | | | Yes | False | | |
| → | CTRI/2020/09/027689 | 27 January 2021 | Assessing the impact of COVID-19 pandemic on Cancer related care in a tertiary cancer hospital of Varanasi district. | Assessing the effect of COVID-19 Pandemic on Cancer-related care and the challenges faced by Cancer Patients in Treatment completion in a Tertiary Cancer Hospital of Varanasi district | | none | 09-09-2020 | 20200909 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47353 | Not Recruiting | No | | | | 18-09-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Divya Khanna→ | | Dept. of Preventive Oncology, OPD 23, OPD Building, DNT Block, Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC), TATA Memorial Cancer Centre, Varanasi 221005, India
Varanasi, UP,221005 → | dkhannakgmc@gmail.com→ | 8800261044→ | Mahamana Pandit Madan Mohan Malaviya Cancer Centre (MPMMCC), TATA MEMORIAL CANCER CENTRE→ | Inclusion criteria: All newly diagnosed cancer patients who got registered at Cancer hospitals namely Homi Bhabha Cancer Hospital (HBCH)and Mahamana Pandit Madan Mohan Malviya Cancer Centre(MPMMCC) in the defined time frame and came for follow up in the mentioned study time frame. All patients who provide telephonic consent will be enrolled in the study.→ | Exclusion criteria: Patients with unknown stage, carcinoma in situ, multiple cancers, cancer and missing/incorrect socio-demographic information and contact (mobile no.) details.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | | 1.Diagnosis-to-Treatment Interval (DTI) in duration. <br/ ><br>2.Stage of cancer at the time of recruitment and stage at the end of follow-up (f/u) period. <br/ ><br>3.Cancer status of the patient at the time of diagnosis and at the end of the follow-up period in terms of remission/no evidence of disease, present/stable and responding to the treatment, progressive disease. <br/ ><br>4.Cancer treatment status at the end of follow-up period. <br/ ><br>Timepoint: The eligible participants will be followed till 6 months from their date of registration at the hospital.→ | | | | Yes | False | | |
| → | CTRI/2020/09/027741 | 27 January 2021 | Role of heat killed Mycobacterium w (Sepsivac) in Corona virus disease 2019 (COVID-19) | A Randomized Double Blind Controlled study to assess the dose related effect of Mycobacterium w on clinical course of Corona Virus Disease 2019 (COVID-19)
| | Cadila Pharmaceuticals | 10-09-2020 | 20200910 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47197 | Recruiting | No | | | | 15-09-2020 | 50 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | Dr Dharampal Singh Sudan→ | | Department Of Pulmonary Medicine
SGT Hospital Medical College and Research Institute
Budhera
Gurugram → | hod.tbchest@sgtuniversity.org→ | 9888603012→ | SGT Hospital Medical College & Research Institute→ | Inclusion criteria: 1.Laboratory confirmed symptomatic COVID-19 patients with ordinal scale of 3& 4. <br/ ><br>2.Female patients who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least 3 months post-dosing. <br/ ><br>3.The patients must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form. <br/ ><br>→ | Exclusion criteria: 1.Patient with ordinal scale of â?¥5 at the time of hospital admission and randomization. <br/ ><br>2.Pregnant and / or lactating female patients. <br/ ><br>3.A family history of congenital or hereditary immunodeficiency. <br/ ><br>4.Any disease condition requiring ICU admission or which in the judgment of the Investigator would compromise the patientâ??s health. <br/ ><br>5.History of dialysis, silicosis, solid organ transplantation such as renal or cardiac transplants, and disorders of the heart, or nervous system, or other metabolic inflammatory conditions, psychiatric, occupational problems that make it unlikely that the patients will comply with the protocol as determined by the investigator. <br/ ><br>6.History of administration of any immunoglobulins, any immunotherapy (antineoplastic chemotherapy, radiation therapy, immunosuppressants to induce tolerance to transplants, and corticosteroids use) and/or any blood products within the 3 months preceding study dosing, or planned future administrations during the study period. <br/ ><br>7.History of allergic reactions or anaphylaxis to Mycobacterium w or its component. <br/ ><br>8.Patients with generalized septic skin conditions. <br/ ><br>9.Presence of any severe systemic/autoimmune disorders as determined by medical history and/or physical examination at the time of screening, which in the judgment of the Investigator would compromise the patientâ??s health or is likely to result in nonconformance to the protocol or a patientâ??s ability to give written informed consent. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Heat- killed Mycobacterium w: <br> Group 1-Heat killed Mycobacterium w suspension group:<br>0.3 ml of Mw daily (0.1 ml x3injections) intradermally at 3 different sites for 3 consecutive days along with standard therapy of COVID-19.<br>Treatment Group 2-Heat killed Mycobacterium w suspension + placebo group:<br>0.3 ml of Mw (0.1 ml x 3 injections) intradermally at 3 different sites for 1 day followed by 0.3 ml (0.1 ml x 3 injections) of placebo intradermally at 3 different sites for next 2 consecutive days along with standard therapy of COVID-19.<br>Treatment Group 3 Placebo group:<br>0.3 ml daily (0.1 ml x 3 injections) of placebo intradermally at 3 different sites for 3 consecutive days along with standard therapy of COVID-19.<br><br>Control Intervention1: Heat Killed Mycobacterium w: Group 1-Heat killed Mycobacterium w suspension group: 0.3 ml of Mw daily (0.1 ml x3injections) intradermally at 3 different sites for 3 consecutive days along with standard therapy of COVID-19. <br>Treatment Group 2-Heat killed Mycobacterium w suspension + placebo group: 0.3 ml of Mw (0.1 ml x 3 injections) intradermally at 3 different sites for 1 day followed by 0.3 ml (0.1 ml x 3 injections) of placebo intradermally at 3 different sites for next 2 consecutive days along with standard therapy of COVID-19. Treatment Group 3 Placebo group: 0.3 ml daily (0.1 ml x 3 injections) of placebo intradermally at 3 different sites for 3 consecutive days along with standard therapy of COVID-19.<br>→ | 1.To compare the symptoms relief over the time among the three treatment group. <br/ ><br>2.To compare the difference in proportion of patients with improved clinical outcome defined by ordinal scale over the time between the treatment groups. <br/ ><br>3.To compare the duration for conversion of Covid-19 positive status to negative between the treatment groups. <br/ ><br> <br/ ><br>Timepoint: 1. Daily assessment of the patient. <br/ ><br>2. At the end of 28 days or discharge of the patient- whichever is earlier.→ | | | | Yes | False | | |
| → | CTRI/2020/09/027719 | 27 January 2021 | Satisfaction of medical students with online learning | Are medical undergraduates satisfied with online learning during COVID-19 pandemic? | | Institute of Post Graduate Medical Education and Research | 10-09-2020 | 20200910 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47277 | Not Recruiting | No | | | | 20-09-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Saikat Kumar Dalui→ | | Department of Pharmacology Room number 1 Division: Pharmacology
244b AJC road → | drnyasmin.sona@gmail.com→ | 9830972292→ | Institute of Postgraduate Medical Education & Research, Kolkata→ | Inclusion criteria: medical undergraduate students→ | Exclusion criteria: → | | | To measure the level of students satisfaction on online learningTimepoint: Single point of recording at the time of enrolment→ | | | | Yes | False | | |
| → | CTRI/2020/09/027691 | 27 January 2021 | Improving real-time COVID-19 monitoring through smartphone voice analysis | A pilot study to determine whether respiratory-responsice vocal biomarkers (RRVB) either alone or in combination with symptom inventory can identify Covid-19 patients versus asymptomatic healthy controls. - SH2020.COV01 | | Sonde Health | 10-09-2020 | 20200910 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46833 | Not Recruiting | No | | | | 17-09-2020 | 350 | Observational | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ms Ulka Gaikwad→ | | Clinical Research Department, First Floor, Bungalow 105 Natraj Society Near Devesh Chitale Karvenagar → | questclinicalservices@gmail.com→ | 9890229919→ | Quest Clinical Services→ | Inclusion criteria: 1 Own an eligible smartphone (iOS or Android) that is able to download and run the Sonde Health app (access to smartphone provided by parent or legal guardian of participants under the age 18 is allowed) <br/ ><br>2 Willing to sign up for a Sonde app account <br/ ><br>3 Agreement with the subject consent information presented on the Sonde app. In case of adolescent subjects, agreement with subject consent information provided by a parent or legal guardian <br/ ><br>4 Stated willingness and ability to comply with all study procedures for the duration of the study <br/ ><br>5 Male or female, aged 12 or above (including adults) <br/ ><br>6 Able to read and speak English or Marathi (required to follow app instructions and provide correct voice elicitations) <br/ ><br>7 Pregnant women are allowed to participate <br/ ><br>Only for subjects in subgroups 1a and 1b (suspected COVID-19 patients): <br/ ><br>8 Confirmed or suspected COVID-19 infection with mild or severe illness severity at screening on Day 1 <br/ ><br>9 Suspected COVID-19 includes patients having at least one of the following symptoms that are present at most 10 days prior to enrollment: <br/ ><br>Cough <br/ ><br>Fever ( >37.5 oC/ 99.5 oF) <br/ ><br>Shortness of breath <br/ ><br>Sore throat <br/ ><br>Diarrhea <br/ ><br>Anosmia <br/ ><br>Loss of taste/ ageusia <br/ ><br>10 COVID-19 viral test ordered at the study site within at most 5 days prior to or on Day 1 <br/ ><br>Only for subjects in subgroup 2: <br/ ><br>11 Hospital staff or co-living family members, or co-living family member of a COVID-19 positive patient that is enrolled in this study <br/ ><br>12 Age 12 and above <br/ ><br> <br/ ><br> <br/ ><br>→ | Exclusion criteria: An individual who meets any of the following criteria will be excluded from participation in this study: <br/ ><br>1. Difficulties with speech production <br/ ><br>2. Difficulties reading or responding to instructions and questions on a smartphone screen <br/ ><br>3. Critical COVID-19 illness severity at screening on Day 1 <br/ ><br>4. Other critical health condition where study participation would place unreasonable burden or risk on the patient as determined by the study site principal investigator <br/ ><br>For subjects in subgroup 2: <br/ ><br>5. History of positive COVID-19 viral or serologic test result any time prior to enrollment <br/ ><br>6. Any hospital staff that is a member of the study team, and staff in the pulmonary and infectious disease departments of the participating institution, or any of their co-living family members→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | The primary outcome is the Sensitivity, Specificity and Diagnostic Odds Ratio of RRVB, either alone or in combination with a symptom inventory, to identify COVID-19 positive patients vs. asymptomatic healthy controls on Day 1Timepoint: Day 1 to 14, each day→ | | | | Yes | False | | |
| → | CTRI/2020/09/027775 | 27 January 2021 | Efficacy and safety clinical study of ES16001 as an adjunct in COVID positive patients. | A prospective, randomized, double blind, placebo-controlled clinical study to evaluate the efficacy and safety of ES16001 as an adjunct to standard of care treatment on mild to moderate COVID-19 positive subjects undergoing treatment for COVID-19 in Hospital Quarantine (Dedicated Covid Health Centre). | | GENECELL CO LTD | 11-09-2020 | 20200911 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47367 | Not Recruiting | No | | | | 19-09-2020 | 60 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | Subham Dutta→ | | 2nd Main Road, Building #06, 3rd Floor. Arekere, Sarvobhogam Nagar. Bangalore 560076. KA INDIA → | deankwak@syncorp.in→ | 8970888899→ | Syncorp Health Pvt. Ltd→ | Inclusion criteria: <br/ ><br>1. Male or self-reported non-pregnant female between 20 to 65 years (both inclusive) of age at the time of enrolment. <br/ ><br>2. Subject or LAR providing written informed consent and agrees to follow study procedure. <br/ ><br>3. Woman with child bearing potential confirming use of primary contraception. <br/ ><br>4. Mild to moderate freshly confirmed COVID-19 positive report in less than 24 hours not requiring emergency or ICU care at the time of enrolment.→ | Exclusion criteria: 1. Severe COVID-19 patients requiring ventilation or oxygen support when diagnosed. <br/ ><br>2. Females who are planning to conceive during the study duration or are pregnant already (self-reported) or are breastfeeding. <br/ ><br>3. Subjects having serious or unstable respiratory disorders (selfreported). <br/ ><br>4. Subject already on immune therapy (self-reported). 5. History of Immunodeficiency or organ transplant (self-reported). <br/ ><br>6. Presence of Autoimmune disease (self-reported). <br/ ><br>7. Current acute infection or exacerbation of a chronic illness (selfreported). <br/ ><br>8. Cancer within last 5 years (self-reported). <br/ ><br>9. Known infection with HIV, Hepatitis B & Hepatitis C (self-reported). <br/ ><br>10. Drug abuse/alcohol abuse (self-reported). <br/ ><br>11. Patients with severe cardiac pathologies or any chronic illness or comorbid illness (self-reported). 12. Patients on treatment for Diabetes Mellitus (self-reported). <br/ ><br>13. Patients with the history of neurological or psychiatric illness (selfreported). <br/ ><br>14. Receiving blood or immunoglobulins within 3 months (selfreported).→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ES16001: Elaeocarpus sylvestris var. ellipticus extract <br>Dosage Regimen: 480 mg per day orally for 10 days<br>Control Intervention1: Standard of care treatment plus placebo: Standard of care treatment as per the revised clinical management protocol for COVID-19 as issued by Govt of India, MoHFW for 10 days.<br>→ | 1. Faster Recovery: clinical symptoms and subjectâ??s critical state defined on 7-point ordinal scale. <br/ ><br>2. Stress: measured by DASS scale <br/ ><br>3. Mental Health: measured through a self-perception Hamilton Anxiety Scale <br/ ><br>4. General Well-being/Systemic Health: measured through a self perception WHO 5 wellbeing scale <br/ ><br>5. RTPCR <br/ ><br>6. Prostaglandin E2, TNF alpha, IL-6 <br/ ><br>Timepoint: Day 1, 5 and 10→ | | 06/12/2020 | | Yes | False | | |
| → | CTRI/2020/09/027769 | 27 January 2021 | Views regarding dental facilities and the manner in which patients wants to use dental facilities during COVID 19 in a hospital setting. | â??Perceptions and utilization of dental care among
patients during COVID 19 pandemicâ?? | | Centre for Dental Education and Research | 11-09-2020 | 20200911 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47390 | Not Recruiting | No | | | | 22-09-2020 | 375 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Harsh Priya→ | | 6th Floor, Centre for Dental Education and Research, AIIMS, New Delhi → | drharshpriya@gmail.com→ | | Centre for Dental Education and Research, AIIMS, New Delhi→ | Inclusion criteria: Patients willing to participate and intellectually and physically capable of responding to the questionnaire were included→ | Exclusion criteria: Patients who did not wish to cooperate with the study protocol were excluded from the present study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Assessment of the perceptions and utilization of dental care by patients during COVID 19 pandemicTimepoint: One month→ | | | | Yes | False | | |
| → | CTRI/2020/09/027786 | 27 January 2021 | Ayurvedic Management of Covid 19 patients | Ayurvedic Management of asymptomatic & mild symptomatic covid 19 patients - A clinical and laboratory assesment - AMC19 | | Principal Secretary Health and Family welfar Govt of Tamilnadu | 14-09-2020 | 20200914 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46950 | Not Recruiting | No | | | | 01-10-2020 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sunil Roy R→ | | Faculty Block,
Government Ayurveda Medical College and Hospital,
Kottar,
Nagercoil → | drrajumd@gmail.com→ | 9751497841→ | Government Ayurveda Medical College and Hospital,Kottar→ | Inclusion criteria: -COVID-19 positive as determined by RT-PCR or <br/ ><br> other approved commercial or public health <br/ ><br> assay <br/ ><br>-Informed consent for the study <br/ ><br>-Asymptomatic stage <br/ ><br>-mild stage (cough, fever) <br/ ><br>-Respiratory rate < 24 per minute and oxygen <br/ ><br> saturation > 94% <br/ ><br>→ | Exclusion criteria: -Participation in any other clinical trial of <br/ ><br> an experimental treatment for COVID-19 <br/ ><br>-Patients with severe COVID-19 disease defined <br/ ><br> as follows respiratory distress,oxygen <br/ ><br> saturation at rest â?¤94%,severe disease <br/ ><br> complications. <br/ ><br> Pregnant women or women who are breastfeeding <br/ ><br>-Immunocompromised patients taking (presently <br/ ><br> on immunosuppressant medication any time <br/ ><br> during last 90 days) <br/ ><br>-Diabetics with >9% HbA1c <br/ ><br>-Patients on antimicrobials, antibiotics, <br/ ><br> antifungals during last 30 days <br/ ><br>-Patients with active malignancy <br/ ><br>-patients with bleeding disorders <br/ ><br>-Pandu (Hb <7) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayurveda Intervension <br>Bharangyadi kashayam,Sudharshanavati,Guduchi paaneeyam,Thaleesadi choornam for 21 days: 1.Bharangyadi kashayam Dose- 50ml with warm water before food<br>2.Sudharshanavati Dose -2 tab twice daily after food with warm water<br>3.Guduchi paaneeyam Dose â?? Whole day in place of water whenever patient feels thirsty<br>4.Thaleesadi choornam Dose-5gms mixed with honey and taken frequently in case of mild symptoms.<br>For 21 days<br><br>Control Intervention1: Group B<br>Control Group: Standard of care therapies as per the latest guidelines released by ICMR<br>Control Intervention2: Control Group<br>Standard treatment as per ICMR guidelines: Standard of care therapies as per the latest guidelines released by ICMR and Tamilnadu government.<br>→ | To prevent covid19 postive cases in asymptomatic <br/ ><br> and mild stages progressing into moderate and <br/ ><br> severe stages assessed by clinical and laboratory <br/ ><br> parameters and to find the time taken to <br/ ><br> convert SARSâ??CoVâ??2 negative determined by RT-PCR.Timepoint: Participants will be provided with study medication orally for 21 days, with close follow-up on weekly basis. <br/ ><br>-Baseline <br/ ><br>-7th day <br/ ><br>-14th day <br/ ><br>-21st day→ | | | | Yes | False | | |
| → | CTRI/2020/09/027785 | 27 January 2021 | Case Control study to check the effect of Measles vaccine in prevention of COVID-19 | A Case Control Study to Assess Effectiveness of Measles Containing
Vaccine in Preventing Coronavirus Disease (COVID-19) - MV-CCS-01 | | Serum Institute of India Pvt Ltd | 14-09-2020 | 20200914 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47016 | Not Recruiting | No | | | | 21-09-2020 | 548 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Prasad Kulkarni→ | | Department of Clinical Research and Pharmacovigilance,
212/2, Off Soli Poonawalla Road,Hadapsar → | drpsk@seruminstitute.com→ | 020-26602384→ | Serum Institute of India Pvt Ltd→ | Inclusion criteria: 1.Participants â?¥1years of age and <18years of age with documented evidence indicating they have been tested for COVID-19 via RT-PCR during pandemic season of COVID-19 between 1 February 2020 till 31 July 2020 residing in PMC, Pune <br/ ><br>2. Participants with a known MCV status i.e. having history and documented evidence (MCH Card, School certificate of MR campaign, anganwadi/health center data) of having received a MCV. <br/ ><br>3. Parents/guardians of participants willing to verbal consent. <br/ ><br>4. Participants whose parents/guardians are willing to answer questions over telephone and share photos of the required documents.→ | Exclusion criteria: 1. Participants with an unknown MCV status. <br/ ><br>2. Participants who did not undergo COVID-19 testing in the defined periodi.e. between 1 February 2020 and 31 July 2020.→ | | Intervention1: Not applicable: Not applicable<br>→ | The proportion of vaccinated participants with a confirmed COVID-19 result (cases) and a negative COVID-19 result (control)Timepoint: Throughout the study period→ | | 20/11/2020 | | Yes | False | | |
| → | CTRI/2020/09/027787 | 27 January 2021 | Effect of wearing N 95 mask along with surgical mask in health care workers in covid era | Impact of prolonged use of N95 mask with overlay surgical mask on the inhaled microclimate andits physiological effects on health care professionals in Covid era | | Dr Ashish Kumar Kannaujia | 14-09-2020 | 20200914 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47329 | Not Recruiting | No | | | | 01-10-2020 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ashish Kumar Kannaujia→ | | Department of Anaesthesiology, A block, Old OPD building, SGPGIMS, Raebareli road, Lucknow → | ashishkannaujia77@gmail.com→ | 9786025292→ | Sgpgi, Lucknow→ | Inclusion criteria: OT/ICU health care workers having <br/ ><br>- Age between 20-55yrs of age group <br/ ><br> - male/female, <br/ ><br> - experienced N95 users ( have used N95 mask previously /Using mask for for last 1 month ) <br/ ><br>-Nonsmoker(defined as having never smoked or not smoked in the last 1 year) will be included in the study <br/ ><br>→ | Exclusion criteria: Any medical condition that could potentially put subjects at risk from prolonged N95 use, like <br/ ><br>-pregnancy, <br/ ><br>-cardiorespiratory diseases (arrhythmias, hypertension) <br/ ><br>-poorly controlled asthma, <br/ ><br>-history of panic attacks or claustrophobia, <br/ ><br>-seizure, <br/ ><br>-unable to fit test the N95 mask(Facial disfiguration,Beard) will be excluded from the study <br/ ><br>→ | | Intervention1: NIL: NIL<br>Intervention2: N95 mask with overlay surgical mask: To study the effect of wearing N 95 mask by the health care workers on the inhaled microclimate and its physiological and subjective effects<br>Intervention3: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | To determine the changes in inhaled gases( ETCO2 and FiCO2, and FiO2 ) during use of N95 mask through a sampling line pinched inside the N95 mask overlayed with surgical maskTimepoint: Baseline, 6hours→ | | | | Yes | False | | |
| → | CTRI/2020/09/027782 | 27 January 2021 | Dental practices in COVID-19 | Practices and protocols during COVID-19 pandemic in Clinical Dental Care- A Unicentric approach | | Dr Aalap Prajapati | 14-09-2020 | 20200914 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47085 | Not Recruiting | No | | | | 23-09-2020 | 1600 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Investigator Blinded | N/A | India→ | Dr Aalap S Prajapati→ | | 213, Department of Dentistry,
Shree Krishna Hospital,
Pramukh Swami Medical College,
Karamsad, Anand → | aalapsp@charutarhealth.org→ | 02692-228121→ | Pramukh Swami Medical College→ | Inclusion criteria: All patients requiring urgent and emergency dental treatment→ | Exclusion criteria: Nil→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: K029- Dental caries, unspecified
→ | | Protocol in Dentistry which will dictate the treatment method for both aerosol and non aerosol generating proceduresTimepoint: 4weeks→ | | | | Yes | False | | |
| → | CTRI/2020/09/027817 | 27 January 2021 | A Phase III Clinical Study to assess the Safety and Efficacy of Ayurvedic Tablets combined with the current available medicine and its impact on lab parameters in Subjects with Uncomplicated Moderate COVID-19 infection. | A Multi-center, Randomized, Double-Blind, Placebo-Controlled Phase III Clinical Study to assess the Safety and Efficacy of BV-4051 Tablets combined with the Current Standard of Care and its impact on Inflammatory Biomarkers in Subjects with Uncomplicated Moderate SARS-CoV-2 infections (COVID-19) | | Bioved Pharmaceuticals Pvt Ltd | 15-09-2020 | 20200915 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46041 | Recruiting | No | | | | 18-09-2020 | 180 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Double Blind Double Dummy | Phase 3 | India→ | Rajeev Singh→ | | KlinEra Global Services
801, Neelkanth Corporate Park
Near Vidhyavihar Station
Vidhyavihar West, Mumbai
KlinEra Global Services
801, Neelkanth Corporate Park
Near Vidhyavihar Station
Vidhyavihar West, Mumbai→ | sujay.patil@Klinera.com→ | 8291279069→ | KlinEra Global Services→ | Inclusion criteria: 1. Male, Female <br/ ><br>2. 18 to 65 years <br/ ><br>3. Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature â?¥ 38 â?? (100.4 °F); plus at least one respiratory symptom (nasal congestion, sore throat, cough, breathing difficulty {Respiratory Rate â?¥24 breaths per minute or Saturation of Oxygen (SpO2) <94% on room air}); and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats). If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed. <br/ ><br>4. Subjects with laboratory confirmed SARS-CoV-2 infection (COVID-19) as determined by the Reverse Transcription Polymerase Chain Reaction (RT-PCR) or other approved commercially available or public health assay prior to Visit 1. <br/ ><br>5. Onset of symptoms at least 48 hours before Visit 1 (Screening; study drug administration visit). The onset of symptoms is defined as either: <br/ ><br>1. Time of the first increase in body temperature to â?¥ 38 â?? (100.4 °F); or <br/ ><br>2. Time when the subject experiences at least one general or respiratory symptom. <br/ ><br> <br/ ><br>6. Subjects who are able to understand and willing to sign the informed consent form (ICF). <br/ ><br>7. Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures. <br/ ><br>8. All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation. <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Subjects with severe COVID-19 infection requiring intensive inpatient treatment. <br/ ><br>2. Subjects requiring mechanical ventilation or ECMO at the time of randomization on Day 1. <br/ ><br>3. 3. Subjects with severe symptoms such as respiratory rate > 30 breaths per minute or saturation of oxygen (SpO2) < 90% on room air. <br/ ><br>4. Subjects with other concurrent infections requiring systemic antimicrobial and/or antiviral therapy prior to screening. <br/ ><br>5. Administration of immunomodulators, interferon inducers, homeopathic, hormonal other than hormone replacement therapy, antiviral and antibacterial drugs during the previous 4 weeks before the first dose. Use of corticosteroids as part of the current standard of care is permitted. <br/ ><br>6. Subjects who have any of the following documented conditions: uncontrolled hypertension systolic blood pressure greater than 140 mm Hg or diastolic blood pressure greater than 90 mm Hg, diabetes, asthma any current or recent, not childhood if resolved, COPD any, cardiac, hepatic, renal including eGFRless than60 and hematopoietic disorders, bleeding tendency or hemorrhagic disease, neurological system disease, compromised immune system including patients receiving immunosuppressant therapy, or those with cancer within the past 5 years or human immunodeficiency virus HIV infection, endocrine disorders including thyroid disorders. <br/ ><br>7. Subjects with anatomical nasal obstruction or gross anatomical abnormalities. For example, nasal polyps or significant nasal septal deviation. <br/ ><br>8. Clinically obese subjects with BMI less than or equal to 40. <br/ ><br>9. Subjects with recent history within 6 months of alcoholism or substance abuse. <br/ ><br>10. Participation in other clinical trial within 1 month, or during the study. <br/ ><br>11. Pregnant or breast-feeding female subjects <br/ ><br>12. Allergy or known allergy to components of study medication. <br/ ><br>13. Previous history of difficulty swallowing capsules. <br/ ><br>14. Any other associated disease or condition which, in the opinion of the investigator, might restrict or impede participation in the study or affect the study results. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 680 mg of Active or Placebo ingredient: Each tablet contains 444 mg of herbal extracts and 231 mg starch and aerosil (excipients or fillers) to be taken 04 tablets twice orally for 14 days<br>Control Intervention1: 680 mg of Active or Placebo ingredient: Each tablet contains 444 mg of herbal extracts and 231 mg starch and aerosil (excipients or fillers)to be taken 04 tablets twice orally for 14 days<br>→ | To investigate clinical efficacy of BV-4051 tablets in alleviation of fever and other symptoms including breathing difficulty, nasal congestion, sore throat, cough, headache, body ache, fatigue, chills or sweats, diarrhea, vomiting, taste and smell disorders in subjects with uncomplicated moderate SARS-CoV-2 infections (COVID-19).Timepoint: Day 7 and Day 14→ | | | | Yes | False | | |
| → | CTRI/2020/09/027841 | 27 January 2021 | In this study IMMUACTIVE would be compared with an inert substance, as a supplement in treatment of COVID-19 patients. | A randomized, double-blind,placebo controlled,multicenter,two-arm,prospective study to assess the efficacy and safety of IMMUACTIVE as an adjunct therapy for COVID-19 patients; An efficacy evaluation trial. | | Sami Sabinsa Group Limited | 16-09-2020 | 20200916 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47174 | Recruiting | No | | | | 22-09-2020 | 100 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Kalpesh Shah→ | | 19/1 & 19/2.
I Main, II Phase,
Peenya Industrial Area,
Bangalore. → | kalpesh@clinworld.org→ | 08028397973→ | ClinWorld (P) Limited→ | Inclusion criteria: 1 Adult male and female between 18 to 50 years of age with BMI less than or equal 35 kg/m2. <br/ ><br>2 COVID-19 positive patients with or without co-morbid conditions (including comorbidity conditions viz diabetes mellitus, hypertension, if any) with ordinal scale score of less than or equal to 3 who requires hospitalization or admission to isolation ward. <br/ ><br>3 Confirmed COVID-19 (SARS-CoV-2) infection by nasopharyngeal swab RT-PCR test within 48hrs. <br/ ><br>4 Uncomplicated symptomatic COVID-19 patients in stable condition with peripheral capillary oxygen saturation (SpO2) >94% on room air at screening. <br/ ><br>5 Subject (both literates and illiterates) willing to give signed informed consent.→ | Exclusion criteria: 1 Asymptomatic COVID-19 positive patients. <br/ ><br>2 Patient with ordinal scale of â?¥4 <br/ ><br>3 On Tube feeding or parenteral nutrition. <br/ ><br>4 Admission to isolation ward or hospitalization >48hrs of confirmed COVID-19 positive test. <br/ ><br>5 Patients on ventilator support. <br/ ><br>6 Patients with uncontrolled, unstable comorbidities <br/ ><br>7 Pre-existing or diagnostic history with chronic lung disease, active malignancy, chronic kidney disease, chronic liver disease. <br/ ><br>8 History of allergic reactions or anaphylaxis to investigational product components. <br/ ><br>9 Patients participation in any another study including macro/micro/any other forms of dietary supplements/multivitamins or oral nutrition supplements. <br/ ><br>10 Patients who are Immunocompromised or those on immunosuppressants <br/ ><br>11 Pregnant and lactating females <br/ ><br>12 Any other condition which the principal investigator thinks may jeopardize the safety of subjects.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: IMMUACTIVE: One capsule daily after breakfast in the morning from Day1 to anytime during the study till 28Days.<br>Control Intervention1: Placebo - Microcrystalline cellulose: One capsule daily after breakfast in the morning from Day1 to anytime during the study till 28Days.<br>→ | 1 To compare the mean duration (days) for reduction in disease severity ordinal scale by 1 in patients supplemented with ImmuActive and placebo. <br/ ><br>2 To compare the mean number of patients with reduction in disease severity by 1 ordinal scale in ImmuActive and placebo.Timepoint: 1 To compare the mean duration (days) for reduction in disease severity ordinal scale by 1 in patients supplemented with ImmuActive and placebo (Day1 to anytime during the study till 28Days). <br/ ><br>2 To compare the mean number of patients with reduction in disease severity by 1 ordinal scale in ImmuActive and placebo (Day1 to anytime during the study till 28Days).→ | | | | Yes | False | | |
| → | CTRI/2020/09/027829 | 27 January 2021 | DARE-19 (Dapagliflozin in Respiratory failure in patients with COVID-19) | An International, Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Study Evaluating the Efficacy and Safety of Dapagliflozin in Respiratory Failure in Patients with COVID-19 - DARE-19 | | Saint Lukes Mid America Heart Institute | 16-09-2020 | 20200916 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45521 | Recruiting | No | | | | 20-09-2020 | 900 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Double Blind Double Dummy | Phase 3 | Argentina;Brazil;India;Mexico;United States of America→ | DR VIJAY KUMAR CHOPRA→ | | Max Super Speciality Hospital, No. 1, 2, Press Enclave Road, Mandir Marg, Saket Institutional Area, Saket
110017 New Delhi , DL
India Max Super Speciality Hospital, No. 1, 2, Press Enclave Road, Mandir Marg, Saket Institutional Area, Saket
110017 New Delh→ | Vijay.Chopra@maxhealthcare.com→ | 011126515050→ | Max Super Speciality Hospital→ | Inclusion criteria: Inclusion Criteria <br/ ><br>For inclusion in the study patients should fulfill the following criteria based on local regulations <br/ ><br>1 Provision of informed consent prior to any study-specific procedures <br/ ><br>2 Male or female patients aged 18 years on the day consent given <br/ ><br>3 Currently hospitalized <br/ ><br>4 Hospital admission no more than 4 days prior to screening <br/ ><br>5 Confirmed SARS-CoV-2 infection by laboratory testing within 10 days prior to screening, or strongly suspected SARS-CoV-2 infection on presentation <br/ ><br>6 Chest radiography or CT findings that, in the opinion of the investigator are consistent with COVID-19 <br/ ><br>7 Mild-moderate disease SpO2 94 with low-flow supplemental oxygen (5 liters or less) <br/ ><br>8 Medical history of at least one of the following <br/ ><br>(a) hypertension <br/ ><br>(b) T2DM <br/ ><br>(c) atherosclerotic cardiovascular disease <br/ ><br>(d) heart failure (with either reduced or preserved LVEF) <br/ ><br>(e) CKD stage 3 to 4 <br/ ><br>Note that the proportion of patients randomized without a confirmed SARS-CoV-2â??positive test will be closely monitored, and may be capped if it becomes greater than anticipated→ | Exclusion criteria: Exclusion Criteria <br/ ><br>Patients should not enter the study if any of the following exclusion criteria are fulfilled <br/ ><br>1 Severe COVID-19 requiring mechanical ventilation via endotracheal intubation, and/or non-invasive ventilation <br/ ><br>2 Expected need for mechanical ventilation with endotracheal intubation, non-invasive ventilation or continuous positive airway pressure (CPAP) within the next 24 hours <br/ ><br>3 Anticipated transfer to another hospital facility which is not another study site within 72 hours <br/ ><br>4 Expected survival of less than 24 hours at the time of presentation in the judgement of the Investigator <br/ ><br>5 eGFR 25 mL/min/1.73 m2 or receiving renal replacement therapy/dialysis <br/ ><br>6 Evidence of oliguria (urine output <500 mL in 24 hours or 0.5 mL/kg/hour) or serum creatinine 1.5x baseline pre-hospitalization value if available at the time of screening <br/ ><br>7 Systolic BP <95 mmHg and/or requirement for vasopressor treatment and/or inotropic or mechanical circulatory support at Screening <br/ ><br>8 History of type 1 diabetes mellitus <br/ ><br>9 Currently receiving or has received in the last 14 days experimental immune modulators and/or monoclonal antibody therapies for COVID-19 <br/ ><br>10 History of diabetic ketoacidosis <br/ ><br>11 Current treatment with any SGLT2i (eg, dapagliflozin canagliflozin empagliflozin ertugliflozin) or having received treatment with any SGLT2i within 4 weeks prior to screening <br/ ><br>12 History of hypersensitivity to dapagliflozin <br/ ><br>13 Any other condition that in the judgment of the investigator would jeopardize the patients participation in the study or that may interfere with the interpretation of study data or if the patient is considered unlikely to comply with study procedures, restrictions and requirements <br/ ><br>14 Women of childbearing potential Current or planned pregnancy or currently lactating <br/ ><br>a Women of childbearing potential are defined as any female who has experienced menarche and who is NOT permanently sterile or post-menopausal <br/ ><br>bPost-menopausal is defined as 12 consecutive months with no menses without an alternative medical cause <br/ ><br>c Women of childbearing potential, who are sexually active, must agree to use a medically-accepted method of birth control for the duration of the study. Acceptable birth control methods include: <br/ ><br>Surgical sterilization (such as a hysterectomy or bilateral tubal ligation) <br/ ><br>ii Progesterone hormonal contraceptives (birth control pills or implants) <br/ ><br>iii Barrier methods (such as a condom or diaphragm) used with a spermicide <br/ ><br>iv An intrauterine device <br/ ><br>15 Involvement in the planning and/or conduct of the study (applies to both Investigator staff and/or staff at the study site) <br/ ><br>16 Previous enrolment in the present study (Note the study design allows 2 attempts to meet the randomization criteria after enrolment) <br/ ><br>17 Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Dapagliflozin 10 mg: Patients will be randomized 1:1 to either dapagliflozin 10 mg or placebo once daily per oral use. Every attempt should be made to maintain patients on dapagliflozin 10 mg or matching placebo during the course of the study. The investigational product should be taken as soon as possible after randomization and then once daily in the morning, at approximately the same time every day, during the 30-day treatment period<br>Control Intervention1: Matching placebo: Patients will be randomized 1:1 to either dapagliflozin 10 mg or placebo once daily per oral use. Every attempt should be made to maintain patients on dapagliflozin 10 mg or matching placebo during the course of the study.<br>→ | To determine whether dapagliflozin 10 mg is superior to placebo in reducing disease progression, complications, and all-cause mortality in patients hospitalized with COVID-19Timepoint: Time to first occurrence of either death from any cause or new/worsened organ dysfunction through 30 days of follow up, defined as at least one of the following <br/ ><br>Respiratory decompensation requiring initiation of invasive or non-invasive mechanical ventilation or continuous positive airway pressure (CPAP) treatment, and/or initiation of veno-venous extracorporeal membrane oxygenation (ECMO) <br/ ><br>New or worsening congestive HFa during current hospitalization <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/09/027842 | 27 January 2021 | Effect of Teleyoga on health care workers involved in Covid 19 duty | Effect of tele yoga on burnout, mental health and immune markers of Health Care Workers involved in COVID-19 duty: a pilot randomized controlled trial | | All India Institute of Medical Sciences | 16-09-2020 | 20200916 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47591 | Not Recruiting | No | | | | 01-10-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | N/A | India→ | Dr Naveen K H→ | | Dept. of Community Medicine and Family Medicine, AIIMS, Basni phase 2 → | naveenkhdoc@gmail.com→ | 9980030138→ | All India Institute of Medical Sciences→ | Inclusion criteria: Consenting health care workers involved in Covid-19 duty at AIIMS Jodhpur and willing to practice yoga for 2 months→ | Exclusion criteria: a. Health care workers practicing any type of yoga <br/ ><br>b. Health care workers suffering from any known illness <br/ ><br>c. Health care workers on any long term medications <br/ ><br>d. Health care workers with any contraindication to the practice of the yoga module <br/ ><br>→ | | Intervention1: Tele yoga: Validated yoga protocol developed by SVYASA University will be delivered by trained and experienced yoga teachers through the online platform<br>Control Intervention1: Control group: Tele yoga intervention will not be provided to the control group during the trial period. However at the end of the trial the recorded yoga module will be shared with control group participants and any questions related to yoga practice will be addressed<br>→ | Burn out, sleep quality, mindfulness, depression, anxiety, stress and immune markersTimepoint: Baseline and after 2 months of intervention→ | | | | Yes | False | | |
| → | CTRI/2020/09/027833 | 27 January 2021 | Prolectin-M in COVID 19 Patients having mild to moderate symptoms not requiring oxygen support | Effect of Prolectin-M: a (1-6) alpha-D-Mannopyranose on SarsCoV2 Viral Copy Numbers: A proof of concept, Open label randomized controlled Trial | | MS Composite Interceptive Med Science Laboratories Pvt Ltd CIMED | 16-09-2020 | 20200916 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46839 | Not Recruiting | No | | | | 16-09-2020 | 10 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | N/A | India→ | VikneswaranG→ | | Department of Clinical Research, Narayana Health City,#258/A, Bommasandra Industrial area, Anekal Taluk, Bangalore Department of Clinical Research, Narayana Health→ | alben.sigamani.dr@narayanahealth.org→ | 888443144→ | Mazumdhar Shaw Medical Center→ | Inclusion criteria: 1. Symptomatic and laboratory-confirmed diagnosis of COVID-19. <br/ ><br>2. Age â?¥18 years and â?¤45 years, male and non-pregnant female <br/ ><br>3. Identified within 72 hours of testing positive on RT PCR. <br/ ><br>4. Able to give informed consent to stay in institutional care and undergo 3 times collection of throat and nasal swabs over 7-day period; Day 1, Day 3 and Day 5 since randomization <br/ ><br>→ | Exclusion criteria: 1.Oxygen saturation at admission â?¤96%. <br/ ><br>2.High temperature â?¥1000 F (â?¥37.50C) not controlled on oral doses of acetaminophen. <br/ ><br>3.Known history of diabetes on oral medications or insulin. <br/ ><br>4.IL-6 levels â?¥ 3times of laboratory reference range and / or significantly elevated levels of CRP, serum ferritin or d-dimer. <br/ ><br>5.Lymphocyte / monocyte ratio â?¤3 or neutrophil / lymphocyte ratio â?¥5 or platelet count â?¤150,000 cells per microliter <br/ ><br>6.On any chronic medications for more than 4 weeks before randomization or active malignancy or having any co-morbidity that increases risk of rapid disease progression. <br/ ><br>7.Previously tested positive and recovered for SarsCov2 <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Prolectin-M: a (1-6) alpha-D-Mannopyranose: Prolectin-M: a (1-6) alpha-D-Mannopyranose 1 tablet every hour orally for 8 hours for 5 days along with standard of care protocols followed for management of Covid 19 patients.<br>Each tablet contains 4 grams of Prolectin-M: a (1-6) alpha-D-Mannopyranose<br>Control Intervention1: Standard of care protocols followed for management of Covid 19 patients: Standard of care protocols followed for management of Covid 19 patients<br>→ | SarsCoV2 viral copy numberTimepoint: Change in viral copy numbers from baseline at day 7→ | | | | Yes | False | | |
| → | CTRI/2020/09/027882 | 27 January 2021 | A Clinical Trial to Evaluate the effect of an Ayurvedic Regimen administered in (COVID â?? 19) Patients | A Randomized, Double-blind, Placebo-controlled Study to Evaluate the effect of an Ayurvedic Regimen administered in nCoV-2 (COVID â?? 19) Patients | | Patanjali Research Institute | 17-09-2020 | 20200917 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47632 | Not Recruiting | No | | | | 28-09-2020 | 150 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Gaurav Kapil→ | | Subharti Medical College and Hospital, Subhartipuram, NH 58, Meerut bypass (Delhi Haridwar Road) → | shirobhisharma@yahoo.in→ | 9456206192→ | Subharti Medical College and Hospital→ | Inclusion criteria: Age 18- 60 years of both male and female gender. <br/ ><br>Laboratory confirmed COVID-19 patients determined through (RT-PCR). <br/ ><br>Patient consenting to participate in the study and follow instructions. <br/ ><br>Agree to attend hospital for follow up on predetermined schedule. <br/ ><br>→ | Exclusion criteria: Laboratory confirmed COVID-19 asymptomatic cases. <br/ ><br>Patients on parenteral nutrition. <br/ ><br>Pregnant and lactating mothers and those who have pregnancy plan. <br/ ><br>Person with serious critical illness like End stage liver or renal disease, Coronary artery disease, Stroke or Renal tubular acidosis. <br/ ><br>Participants with any immunosuppressive medication or in an immune compromised state or hematological disease.Patients on any kind of Ayurveda treatment or any other alternative and complementary medicinal systems such as Homeopathy, Unani, Siddha and in particular requiring oral therapy of any kind. <br/ ><br>→ | Health Condition 1: B338- Other specified viral diseases
→ | Intervention1: Ayurvedic Regimen: Divya Swasari Vati 2 tablets orally with luke-warm water, thrice a day, half an hour before the breakfast, lunch and dinner. <br>Divya Coronil Tablet2 tablets orally with luke-warm water, thrice a day, half an hour after the breakfast, lunch and dinner.<br>Divya Anu Taila (For Nasal Therapy) 4 drops of Anu Taila in both the nostrils, once per day, relatively 1 hour before breakfast. <br><br><br>Control Intervention1: Placebo Group: Placebo against Divya Swasari Vati <br>Placebo against Divya Coronil<br>Placebo Nasal drop aganist anu taila<br>→ | To render proportion of patient showing clinical improvement in mild, moderate and severe COVID-19 cases. <br/ ><br>Mean time (days) for clinical recovery. <br/ ><br>Timepoint: Details will be recorded on Day 0 i.e. the day of admission (baseline), Day 3, Day 7 ,Day 14 and on one follow up visit on Day 28. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/09/027881 | 27 January 2021 | An observational multi-center study on COVID 19 disease to study on HERD immunity | An observational multi-center study on COVID 19 disease to study on HERD immunity in the population based on random sampling through conducting at two time points to infer epidemic trajectory. - SARS-CoV2 infection Survey/2020 | | Public Health Department | 17-09-2020 | 20200917 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46661 | Not Recruiting | No | | | | 17-09-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Dhananjay Lad→ | | CROM Premises, Building no. 2, Opp. Caculo Mall, St. Inez, Panaji
North Goa
GOA
India → | laddhl@gmail.com→ | 9158592177→ | CROM Clinical Research & Medical Tourism Pvt. Ltd.→ | Inclusion criteria: 1.Apparently Healthy subjects will be recruited. <br/ ><br>2.Subjects of both sexes aged more than 10 years old. <br/ ><br>3.Willing and able to provide written informed consent <br/ ><br>4.Subjects who has not tested positive for COVID 19 infection in the past.→ | Exclusion criteria: 1.Subjects having less than 10 years of age <br/ ><br>2.Subjects already tested positive for the COVID19 infection in the past and cured. <br/ ><br>3.Critical co-morbidities. <br/ ><br>→ | | | Compared to the other infections, COVID infections are more asymptomatic and there is a chance to recover without any medications or standard of care for COVID-19 disease.Timepoint: 14 days→ | | 25/09/2020 | | Yes | False | | |
| → | CTRI/2020/09/027862 | 27 January 2021 | Study on placenta of women with coronavirus disease 2019 (COVID-19) | Study on placenta of women with coronavirus disease 2019 (COVID-19) and its correlation with pregnancy and neonatal outcomes | | NWMH | 17-09-2020 | 20200917 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47505 | Not Recruiting | No | | | | 28-09-2020 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ketki S Kulkarni→ | | Nowrosjee Wadia Maternity Hospital,
Department of Obstetrics and Gynaecology
Acharya Donde Marg Parel, Mumbai → | drketkiskulkarni@gmail.com→ | | Nowrosjee Wadia Maternity Hospital→ | Inclusion criteria: Inclusion criteria <br/ ><br>Cases: <br/ ><br>1.Pregnant women ( >18 years) with laboratory confirmed diagnosis (RT PCR of nasopharyngeal and throat swab) of COVID-19 <br/ ><br>2.Pregnant women who are willing to take part in study. <br/ ><br>Controls: <br/ ><br>Pregnant women ( >18 years) without any history of COVID-19 disease confirmed COVID -19 negative by laboratory diagnosis (RT PCR of nasopharyngeal and throat swab) within last 5 days. <br/ ><br> <br/ ><br> <br/ ><br>→ | Exclusion criteria: Women not willing to take part in the study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | This study will provide first-hand information on the clinical course of COVID-19 in pregnancy and give an understanding of its pathogenesis. It will also provide an information of the possibility of vertical transmission of the virus via the placenta.Timepoint: Pregnancy outcome is studied at delivery and neonatal outcome at the end of one week→ | | | | Yes | False | | |
| → | CTRI/2020/09/027908 | 27 January 2021 | STRESS AND COPING AMONG HEALTH WORKERS DURING COVID | PERCEIVED STRESS AND COPING AMONG ONCOLOGY HEALTH CARE WORKERS DURING COVID-19 PANDEMIC: A CROSS-SECTIONAL STUDY FRPM A TERTIARY CENTRE | | Malabar Cancer Centre | 18-09-2020 | 20200918 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47619 | Not Recruiting | No | | | | 28-09-2020 | 600 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Jisha Abraham→ | | Division of Psycho-oncology
Malabar Cancer centre, Moozhikkara, Thalassery → | jishasarah@gmail.com→ | 8086767706→ | Malabar Cancer Centre→ | Inclusion criteria: 1. All oncology health care workers, who are currently on duty and are willing to participate in the study. <br/ ><br>2. All permanent/contract/outsourced staff of the hospital. <br/ ><br>3. Able to read and write English or Malayalam. <br/ ><br>→ | Exclusion criteria: 1. Oncology health workers who are not willing for the study. <br/ ><br>2. Fellows, students, interns, observers, staffs on contract for less than 6 months. <br/ ><br>→ | | | Understand the stress among oncology health care workers during Covid 19 pandemic <br/ ><br>And the coping styles they use to cope with stressTimepoint: baseline→ | | | | Yes | False | | |
| → | CTRI/2020/09/027904 | 27 January 2021 | Autologous whole blood injection as treatment for Covid-19 infection | Autologous whole blood injection as treatment for Covid-19 infection | | Dr M Christopher | 18-09-2020 | 20200918 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47392 | Not Recruiting | No | | | | 02-10-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr M Christopher→ | | Shifa Hospitals,
Department of Anesthesiology,
82, Near Junction Flyover,
Kailashapuram Middle Street,
Tirunelveli Junction,
Tirunelveli → | dr.judith.chris@gmail.com→ | 9487410467→ | Shifa Hospitals→ | Inclusion criteria: 1) Patients in the age group of 14 years and above <br/ ><br>2) Both male and female patients <br/ ><br>3) Confirmed cases of COVID 19 admitted for treatment in Shifa hospital; COVID positive confirmed by RT-PCR <br/ ><br>4) Presence of IgM antibodies through rapid test kit <br/ ><br>5) Willing to give consent for the study and take part actively <br/ ><br>6) Patients willing to adhere to drugs protocol as per ICMR guidelines/ WHO guidelines <br/ ><br>7) In test arm, patients who are accepting to AWB therapy in addition to standard drugs→ | Exclusion criteria: 1) Children lesser than 14 years of age <br/ ><br>2) Presence of IgG antibodies through rapid test kit <br/ ><br>3) Patients hypersensitive to blood products or blood transfusion <br/ ><br>4) Any Co-morbid conditions <br/ ><br>5) Patients who are critically ill are excluded from the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Autologous whole blood injection: 2.5 ml of blood will be drawn from a vein in the cubital fossa with a 20G needle and a 5 ml syringe and the drawn blood will be<br>immediately (within 2 minutes) injected intramuscularly into the gluteal muscle of the same subject (once a day) from whom the blood was drawn on day on Day 1 and Day 3.<br>Control Intervention1: Standard therapy for Covid therapy: Treatment protocol for Covid 19 infection will be followed as per ICMR recommendations<br>→ | RT-PCR test turning negative is the end pointTimepoint: 14days→ | | | | Yes | False | | |
| → | CTRI/2020/09/027903 | 27 January 2021 | Testing the efficacy and safety of a blood product COVID-19 Hyper-Immuneglobulin (Human) Solution in Participants with Active COVID-19 | A Prospective, Open-Label, Two-Arm, Parallel-Group, Randomized, Controlled, Multi-Centric Trial for Evaluation of Efficacy and Safety of COVID-19 Hyper-Immuneglobulin (Human) Solution in Participants with Active COVID-19 | | Intas Pharmaceuticals Limited | 18-09-2020 | 20200918 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47147 | Not Recruiting | No | | | | 22-09-2020 | 60 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Mr Prashant Modi→ | | Lambda House, Department of Project Management & Regulatory
Affairs, Plot No. 38, Survey No. 388 Near Silver Oak Club, S. G.
Highway,Gota → | namanshah@lambda-cro.com→ | 07940202389→ | Lambda Therapeutic Research Ltd→ | Inclusion criteria: 1 <br/ ><br>Participant and/or legally acceptable representative must sign an ICF to participate in the study indicating that the participant understands the purpose of, and procedures required for the study as described in this protocol and is willing to and will be able to adhere to requirement of the protocol. <br/ ><br>2 <br/ ><br>Participant must be 18 to 65 years of age (both inclusive), at the time of signing the informed consent. <br/ ><br>3 <br/ ><br>Participants must have documented laboratory-confirmed SARS-CoV-2 infection as determined by reverse transcription- polymerase chain reaction (RT-PCR) in any specimen, within less than 72 hours prior to randomization; <br/ ><br>4 <br/ ><br>Participants with moderate or severe active COVID-19 (Clinical Management of COVID-19 Guidelines of MOHFW) at screening and baseline defined as <br/ ><br>a. Radiological evidence of pulmonary infiltrates or Clinical features such as dyspnea and/or hypoxia, fever, cough, AND <br/ ><br>b. SpO2 of less than 94 % on room air AND <br/ ><br>c. Respiratory rate of greater than or equal to 24 per minute <br/ ><br>5 <br/ ><br>A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: <br/ ><br>a. Is not a woman of childbearing potential (WOCBP) <br/ ><br>OR <br/ ><br>b. Is a WOCBP and using an acceptable contraceptive method as described in Appendix 10.4 during the intervention period and at a minimum 30 days until after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. <br/ ><br>c. A WOCBP must have a negative highly sensitive pregnancy test [serum] within 4 days before the first dose of study intervention. <br/ ><br>d. Additional requirements for pregnancy testing during and after study intervention are in Appendix 10.2 <br/ ><br>e. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy. <br/ ><br>6 <br/ ><br>Male participants are eligible to participate if they agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ ><br>a. Must agree not to donate sperm for the purpose of reproduction <br/ ><br>PLUS <br/ ><br>b. Must agree to use contraception /barrier as detailed below <br/ ><br>i. a male participant must wear a condom when engaging in any activity that allows for passage of ejaculate to another person <br/ ><br>ii. Should also be advised of the benefit for a female partner to use a highly effective method of contraception described in Appendix 10.4 as a condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant→ | Exclusion criteria: 1 <br/ ><br>Participant requiring invasive ventilation or having hemodynamic instability (MOHFW guideline) or multiple organ dysfunction/failure or evidence of bacterial superinfection (as defined by Procalcitonin level greater than or equal to 0.5 μg/L or other applicable diagnostic parameters as per standard medical care) as per the independent clinical judgment of the Investigator at screening and /or baseline. <br/ ><br>2 <br/ ><br>Documented medical history of known allergies, hypersensitivity, or intolerance to intravenous immunoglobulin or other injectable form of IgG or blood products. <br/ ><br>3 <br/ ><br>Documented medical history of known IgA deficiency. <br/ ><br>4 <br/ ><br>Participants with a lifetime history of at least one thrombotic event including deep vein thrombosis, cerebrovascular accident, pulmonary embolism, transient ischemic attacks, or myocardial infarction. <br/ ><br>5 <br/ ><br>Participants who have received any blood products within 30 days prior to randomization. <br/ ><br>6 <br/ ><br>Participant with more than 5 days of COVID-19 specific hospitalization prior to the first administration of treatment at baseline. <br/ ><br>7 <br/ ><br>Participants who have more than 10 days between the onset of symptoms and the day of first administration of treatment at baseline. <br/ ><br>8 <br/ ><br>Pregnant or breastfeeding female participants. <br/ ><br>9 <br/ ><br>Currently receiving renal replacement therapy/dialysis OR Creatinine clearance less than 50 mL/min using the Cockcroft-Gault formula. <br/ ><br>10 <br/ ><br>Documented medical history of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease, or tests positive for HBsAg or anti-HCV at Screening. <br/ ><br>11 <br/ ><br>Documented medical history of human immunodeficiency virus (HIV) antibody positive, or tests positive for HIV at Screening. <br/ ><br>12 <br/ ><br>Currently receiving or has received in the last 14 days, experimental immune modulators, and/or monoclonal antibody therapies <br/ ><br>13 <br/ ><br>Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline <br/ ><br>14 <br/ ><br>Participants who have received organ transplantation or major surgery in the past 6 months. <br/ ><br>15 <br/ ><br>Participants whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal. <br/ ><br>16 <br/ ><br>Co-morbid systemic illnesses (uncontrolled diabetes, uncontrolled hypertension, cardiac disease, chronic lung disease, chronic kidney disease, immune-suppression and cancer or other severe concurrent disease) which, in the judgment of the investigator, would make the participant inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed treatment. <br/ ><br>17 <br/ ><br>Current participation in another interventional clinical trial (with an investigational drug) that is not an observational registry and have received an investigational intervention 30 days or 5 half-lives (whichever is longer) before the signing the consent. <br/ ><br>18 <br/ ><br>Participation in any other clinical trial of an experimental treatment for COVID-19. <br/ ><br>19 <br/ ><br>Any other clinical/social/ psychiatric condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g. compromise the well-being) or that could prevent, limit, or confound the prot→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: COVID-19 Hyper-Immuneglobulin (Human) solution: Manufacturer- Intas Pharmaceuticals Limited;<br>Dosage Level(s)- 30 mL as an intravenous injection on day 1 & 2 at the rate of not more than 0.5mL/kg/h;<br>Route of Administration- Intravenous injection<br>Control Intervention1: Standard of care: Standard of care is the treatment algorithm/modalities to be given at discretion of the investigator as defined in the latest Guidelines on Clinical Management of COVID-19 issued by Ministry of Health and Family Welfare, Government of India<br>→ | To compare the efficacy of treatment with COVID-19 Hyper-Immuneglobulin (Human) plus standard of care versus only standard of care in participants with active COVID-19Timepoint: Mean change from Day 1 to Day 8 in clinical outcome of treatment with COVID-19 Hyper-Immuneglobulin (Human) as compared to the control arm as assessed by 8-point ordinal scale→ | | | | Yes | False | | |
| → | CTRI/2020/09/027910 | 27 January 2021 | Transcendental Meditation (TM) to reduce stress and improve immunity of health care providers during COVID-19 pandemic | Transcendental Meditation (TM) to redUce stRess and enhance iMmunity of hEalth care woRkers during COVID-19 pandemiC: A randomized trial - TURMERIC trial | | All India Institute of Medical Sciences | 18-09-2020 | 20200918 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45292 | Not Recruiting | No | | | | 15-10-2020 | 80 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Rini Vohra→ | | School of Science of Consciousness
Maharishi University of Information Technology (MUIT), Noida, UP - 201304 → | dr_hkb75@yahoo.com→ | 7838621462→ | All India Institute of Medical Sciences (AIIMS), New Delhi→ | Inclusion criteria: 1. Any healthcare provider including doctors, nurses, and other healthcare staff involved in COVID-19 patient care at All India Institute of Medical Sciences is eligible for the study. <br/ ><br>2. Agreement to attending the 5-day session for learning TM and dedicating 40 mins per day for practice TM at home/workplace <br/ ><br>→ | Exclusion criteria: 1. Healthcare provider with a history of autoimmune disorders/compromised immunity/trauma related issues/complicated diabetes/renal disorders/etc. <br/ ><br>2. Those with any form of recreational drug use within the past 15 days from learning TM, are not eligible to learn TM and thus will be excluded from this study or will be taught at a later time. <br/ ><br>3. Any individual who has learnt TM in the past. <br/ ><br>4. Any individual currently practicing any other form of meditation. <br/ ><br>→ | | Intervention1: Transcendental Meditation (TM): The participating Health Care providers including doctors, nurses, and other healthcare staff involved in COVID-19 patient care will be randomized into two groups: Intervention (TM) and Control (no TM). Control group will continue with their usual daily activities. The intervention group will practise TM besides their regular daily activities.<br>Control Intervention1: Stress and Immunity: Perceived stress will be measured using Perceived stress scale (PSS). Self-perceived immune status and Health related quality of life will be assessed by Short Form-36.<br>Biochemical stress level will be measure by Salivary cortisol, salivary amylase,Serum Cortisol and Beta-Endorphins levels <br>Expression of immune cells, B and T lymphocytes Plasma cells, natural killer (NK) cells, inflammatory Cytokines (Il-6,8,10, and tumor necrosis factor (TNF)-α will be measured.<br><br>→ | Perceived stress, measured using Perceived stress scale (PSS)Timepoint: Baseline and at one, two and three months post intervention→ | | | | Yes | False | | |
| → | CTRI/2020/09/027907 | 27 January 2021 | Stress of Doctors in Covid era | Stress of Doctors in Covid era | | NOT APPLICABLE | 18-09-2020 | 20200918 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47598 | Not Recruiting | No | | | | 01-10-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Jyotsna Maddury→ | | Department of Cardiology,2nd Floor, Specialty block,Nizams institute of Medical Sciences,Punjagutta Department of Cardiology,2nd Floor, Specialty block,Nizams institute of Medical Sciences,Punjagutta→ | janaswamyjyotsna@gmail.com→ | 09491073627→ | Nizams Institute Of Medical Sciences→ | Inclusion criteria: ALL POST MBBS DOCTORS WHETHER TREATING COVID PATIENTS OR NOT, WILLING TO ANSWER THE QUESTIONNAIRE→ | Exclusion criteria: 1.DOCTORS ALREADY SUFFERING WITH COVID <br/ ><br>2.DOCTORS NOT WILLING TO PARTICIPATE/ANSWER THE QUESTIONNAIRE→ | | | The aim of this observational study is to evaluate acute stress levels experienced by the Doctors working in this COVID era, factors of stress in COVID treating and non treating Doctors and the types of stressTimepoint: The aim of this observational study is to evaluate acute stress levels experienced by the Doctors working in this COVID era, factors of stress in COVID treating and non treating Doctors and the types of stress→ | | | | Yes | False | | |
| → | CTRI/2020/09/027914 | 27 January 2021 | Evaluation of efficacy of Fixed Ayurvedic Regimen of Giloy Ki Ghan Vati,Tulsi Tablets,Kalmegh Tablets and Dabur Chyawanprash in COVID-19 | A Prospective, Randomized, Open Label Blinded End Point (PROBE) Two arm Comparative Clinical Study to Evaluate the Efficacy and Safety of Fixed Ayurvedic Regimen (Giloy Ki Ghan Vati, Tulsi Tablets, Kalmegh Tablets and Dabur Chyawanprash) as an Add on to Conventional Treatment in the management of Mild and Moderate COVID-19 Patients - NIL | | Dabur India Limited | 19-09-2020 | 20200919 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47442 | Recruiting | No | | | | 22-09-2020 | 72 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Outcome Assessor Blinded | Phase 2/ Phase 3 | India→ | Dr Sanjay Tamoli→ | | A-Wing, 402/A-B-C, Jaswanti Allied Business Center Ramchandra Lane, Off Link Road,
Kachpada → | arun.gupta@dabur.com→ | 9910200255→ | Dabur India limited→ | Inclusion criteria: 1. Male and female subjects between the age groups of 18 and 60 years <br/ ><br>2. Clinical presentation with Laboratory (RT-PCR or Rapid antigen or any other test for COVID19 as per current guidelines) confirmed infection of COVID-19 <br/ ><br>3. Subjects having symptoms not more than 3 days <br/ ><br>4. Patients with mild to moderate symptoms [as per US-CDC classification of COVID-19 (Ref: www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidancemanagement-patients.html) (Mild symptoms up to mild pneumonia) <br/ ><br>5. Ready to provide written informed consent for participation in the study <br/ ><br>6. Willing to follow COVID-19 (prevention and containment) related guidelines issued from time to time by Govt./ local health authority throughout the study period.→ | Exclusion criteria: 1. Patients suffering from severe COVID-19 disease as judged by a physician and fulfilling at least two of the following three criteria - (i) Respiratory distress at room ambience (â?¥30 breaths per min) (ii) Oxygen saturation at rest is less than or equal to 93% (peripheral digital oxymeter) and requiring oxygen support for over one hour to normalize (iii) Any of the known COVID-19 complications and emergency procedures which may require shift/admission in intensive care unit such as respiratory failure, adult respiratory distress syndrome, requirement of oxygen support for over 1 hour, requirement of mechanical ventilation, septic shock, or severe non-respiratory organ dysfunction or failure. <br/ ><br>2. Patients with known history of Diabetes Mellitus or Chronic, Severe, Unstable, Uncontrolled co-existent medical illness like Hypertension, Cardiac, liver, kidney lung, immune compromised status or any other condition which in the opinion of the investigators, makes the patient unsuitable for enrolment or may put the patient at increased risk during the study or surgical condition that would require surgical intervention at the time of screening <br/ ><br>3. Patients having difficulty in swallowing oral medications. <br/ ><br>4. AYUSH system-based contraindications <br/ ><br>5. Patients who have participated in other clinical trials within last 1 month; <br/ ><br>6. Pregnant or Lactating <br/ ><br>7. Known hypersensitivity to Investigational Products (Ayurvedic Formulations) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tulsi tablets: 1 Tablet two times a day for 28 days<br>Intervention2: Giloy ki Ghanvati: 1 Tablet two times a day for 28 days<br>Intervention3: Kalmegh Tablets: 1 Tablet two times a day for 28 days<br>Intervention4: Dabur chyawanprash: 1 Teaspoonful (Approx 10-12 grams) two times a day for 28 days<br>Control Intervention1: Standard care: Conventional Treatment as advised / prescribed by concerned health authorities<br>→ | 1. Mean time (days) required for clinical recovery from COVID19 (Day of randomization to the day of clinical recovery and from the day of first noticed symptoms) (Criteria for clinical recovery as mentioned below) <br/ ><br>2. Proportion of patients showing clinical recovery between the two groupsTimepoint: Baseline /Screening, Evaluation during hospitalization, At Discharge Visit, Post Discharge at 14 and 28 day→ | | | | Yes | False | | |
| → | CTRI/2020/09/027917 | 27 January 2021 | Surveillance of Bala Vriddhikara Bhava (FACTORS RESPONSIBLE FOR HOST IMMUNITY) in COVID-19 subjects | observational study of Balavriddhikara Bhava(Factors responsible for host immunity) in Covid-19 subjects - BVB in covid | | All India Institute of Ayurveda | 21-09-2020 | 20200921 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47662 | Not Recruiting | No | | | | 30-09-2020 | 200 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Meera K Bhojani→ | | Room no. 302, 3rd Floor,Academic Block, All India Institute of Ayurveda,Gautampuri,Sarita Vihar,New Delhi ground floor Academic block, All India Institute of Ayurveda, sarita vihar, New Delhi→ | meera.samhita@aiia.gov.in→ | 9990247410→ | All India Institute Of Ayurveda→ | Inclusion criteria: Covid-19 Positive Subjects (with/without comorbidities) <br/ ><br>Asymptomatic and have tested positive for COVID-19 <br/ ><br>Sick with mild symptoms and have tested positive for COVID-19 <br/ ><br>Sick with moderate symptoms and have tested positive for COVID-19 <br/ ><br>Sick with severe symptoms and have tested positive for COVID-19 <br/ ><br>Recovered from COVID -19 (symptomatically and on Lab parameters) <br/ ><br>→ | Exclusion criteria: Participants unwilling to participate→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: not applicable: not applicable, its a observational study<br>→ | Knowledge of host responses are essential for formulating strategies for antiviral treatment and epidemiological control of COVID-19. The study would give us the knowledge/understanding of host Reponses to COVID 19 in terms of Prakriti, Vaya, Desha, Kala, Vyayama, Sharira, Satva, Satmya, Ahara habits of the individual.Timepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/09/027915 | 27 January 2021 | Tele-yoga for prevention and management of COVID-19 | Tele-yoga as an adjunct intervention for prevention and management of COVID-19: a non-randomized clinical trial | | AYUSH | 21-09-2020 | 20200921 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46754 | Not Recruiting | No | | | | 01-10-2020 | 136 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Manjunath NK→ | | Swami Vivekananda Yoga Anusandhana Samsthana SVYASA 19, Eknath Bhavan, Gavipuram Circle, Kepegowda Nagar, Bengaluru → | nkmsharma@svyasa.org→ | | SVYASA Yoga University→ | Inclusion criteria: Patients diagnosed with mild or moderate COVID-19 based on clinical symtoms of <br/ ><br>fever, respiratory and other symptoms, and /or the manifestation of pneumonia as <br/ ><br>confirmed by radiographic imaging. <br/ ><br> <br/ ><br>Severe patients who meet the definition of severe pneumonia (Shortness of <br/ ><br>breath,RRâ?¥30 bpm;In a resting state:SPO2â?¤93%;PaO2/FiO2â?¤300mmHg) <br/ ><br> <br/ ><br>Patients with comorbities of Type 2 Diabetes and/or hypertension <br/ ><br>Willing to participate in this study, willing to participate in regular follow-up <br/ ><br>during the study. <br/ ><br>→ | Exclusion criteria: Prior experience of yoga <br/ ><br> <br/ ><br>Breastfeeding and pregnant patients were excluded based on their declaration and pregnancy test results when required. <br/ ><br> <br/ ><br>Patients diagnosed with severe or critical COVID-19: respiratory failure, septic shock, and/or multiple organ dysfunction (MOD) or failure (MOF). <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J708- Respiratory conditions due to other specified external agents
→ | Intervention1: Tele-yoga: Integrated yoga intervention of 30 minutes with 10 minutes of pranayama, twice a day.<br>Control Intervention1: NIL: NIL<br>→ | Clinical improvement through odds ratio of 7 point ordinal scaleTimepoint: Time frame of 15 days followed by follow up of 1 month→ | | | | Yes | False | | |
| → | CTRI/2020/09/027941 | 27 January 2021 | Single arm study of Itolizumab in the treatment of COVID 19 complication. | A multicentre, single arm, phase IV clinical trial to evaluate the safety and efficacy of Itolizumab for the treatment of cytokine release syndrome (CRS) in moderate to severe acute respiratory distress syndrome (ARDS) patients due to COVID 19. - COVID 19 | | Biocon Biologics India Limited | 21-09-2020 | 20200921 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46023 | Not Recruiting | No | | | | 26-09-2020 | 300 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 4 | India→ | Sivakumar Vaidyanathan→ | | Biocon Biologic India Limited, Biocon House, Semicon Park Electronics City Phase 2→ | subramanian.l101@biocon.com→ | 08028085305→ | Biocon Biologic India Limited→ | Inclusion criteria: 1. Male or female adults above >18 years <br/ ><br>2. Informed consent for participation in the study <br/ ><br>3. Confirmed virological diagnosis of SARS-CoV2 infection (RT-PCR) <br/ ><br>4. Hospitalized with ARDS due to clinical worsening of COVID-19 infection <br/ ><br>5. Oxygen saturation at rest in ambient air â?¤94% <br/ ><br>6. Patients who are in moderate to severe ARDS as defined by PaO2/Fio2 ratio of â?¤ 200 <br/ ><br>7. Baseline serum ferritin level â?¥ 400 ng/mL and IL-6 levels greater than 3 times ULN, if known/available <br/ ><br> <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Known severe allergic reactions to monoclonal antibodies <br/ ><br>2. Active tuberculosis (TB) infection <br/ ><br>3. History of inadequately treated tuberculosis or latent tuberculosis <br/ ><br>4. In the opinion of the investigator, progression to death is highly probable, irrespective of the provision of treatments <br/ ><br>5. Patient on invasive mechanical ventilator support <br/ ><br>6. Patient receiving oral anti-rejection or immune-suppressive drugs regularly in the last 6 months <br/ ><br>7. Patient on treatment of anti-IL-6 as a part of supportive care <br/ ><br>8. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination <br/ ><br>9 Patients with known history of Hepatitis B, Hepatitis C or HIV→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Intervention: 1.6 mg/kg given as IV infusion as a starting dose. Additional dose of 0.8mg/Kg can be administered after 7 days based on the physicianâ??s discretion.<br>Control Intervention1: NA: NA<br>→ | <br/ ><br>Incidence, nature and severity of adverse events (severe acute infusion related reactions and higher) causally related to Itolizumab as assessed by Common Terminology Criteria for Adverse Event (CTCAE)Timepoint: Up to 1 month→ | | | | Yes | False | | |
| → | CTRI/2020/09/027938 | 27 January 2021 | Study of Particle Life Sciences Formulation in management of COVID-19 | A randomised double blind trial to evaluate the activity of formulation of Particle Life Sciences in the management of SARS-CoV-2 Infection. | | Particle Life Sciences | 21-09-2020 | 20200921 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47586 | Not Recruiting | No | | | | 25-09-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Dr Sagar Mandlik→ | | Department of Medicine, Raghukul Sankul, Behind Hotel Bandhuraj, Pathardi Phata, Nashik. → | sagar.vakratund@gmail.com→ | 9820753549→ | Vakratund Hospital→ | Inclusion criteria: Quarantine/non hospitalized or hospitalized and fulfils WHO case definition, including a positive RT-PCR confirmed COVID-19 illness. <br/ ><br>Age more than 18 & less than 65 years of either sex. <br/ ><br>Mild to Moderately COVID-19 disease (NEWS score less than or equal to 8). <br/ ><br>Patients with oxygen saturation (SpO2) less than 95%. <br/ ><br>Respiratory rate is more than 20/min. <br/ ><br>Pulse rate more than 90/min. <br/ ><br>Imaging evidence of lung infection in the form of Reticulonodular opacities, ground-glass opacities and consolidation.→ | Exclusion criteria: Pregnant women. <br/ ><br>Breastfeeding women. <br/ ><br>Requiring ICU admission at screening. <br/ ><br>Patients above 65 years of age and below 18 Years. <br/ ><br>Past History of MI, Epileptic episodes. <br/ ><br>Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which is at critical stage at screening. <br/ ><br>Asymptomatic patients. <br/ ><br>Patients unwilling for informed consent. <br/ ><br>Patients with prolonged QTc interval on ECG. <br/ ><br>In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision <br/ ><br>of treatments. <br/ ><br>Participant with any immunosuppressive condition or hematological disease. <br/ ><br>Participation in any other A.S.U and H protocol.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Particle Life Sciences Formulation Capsules: Each capsule to be consumed orally twice a day immediately after meals for 10<br>days<br>Control Intervention1: Standard Treatment protocol designed by MOHFW/ICMR: Tab. Hydroxychloroquine (400 mg) BD on 1st day followed by<br>200 mg BD for 4 days; Azithromycin 500 mg 1-0-0 for 3 days (if needed); and Vitamin support for 10 days<br>→ | Severity of disease in SARS-CoV-2. <br/ ><br>Change in clinical symptom presentation in Cough, breathlessness, persistent pain and pressure in the chest, bluish discoloration of lips/face. <br/ ><br>Serum levels of CRP, D-Dimer, Ferritin, IL-6 (At baseline and end of the study as per availability). <br/ ><br>Clinical status expressed in percentage of subjects based on Ordinal Scale for Clinical <br/ ><br>Improvement. <br/ ><br>Duration of symptoms in Patients of SARS-CoV-2 measured in days.Timepoint: Screening visit, Day 0, Day 4, Day 7 and Day 10 i.e. end of study→ | | | | Yes | False | | |
| → | CTRI/2020/09/027916 | 27 January 2021 | Covid19 Post Treatment Restorative Healthcare | Implementation of "AAROGYAM"-A Special Programme Of Tamilnadu Government with Ayurvedic Interventions in the Convalescence Period OF COVID19 Cases - ACC19 | | Principal Secretary Health and Family welfare Govt of Tamilnadu | 21-09-2020 | 20200921 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47333 | Not Recruiting | No | | | | 01-10-2020 | 150 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Senthiarasi TM→ | | Faculty Block
Govt Ayurveda Medical College and Hospital
Kottar
Nagercoil → | senthiarasi@yahoo.com→ | 7904542373→ | Government Ayurveda Medical College and Hospital,Kottar→ | Inclusion criteria: COVID-19 positive after treatment who turned negative as determined by RT-PCR or other approved commercial or public health assay. <br/ ><br>Informed consent for the study. <br/ ><br>→ | Exclusion criteria: Individuals with uncontrolled, unstable comorbidities. <br/ ><br>Pregnant and lactating females. <br/ ><br>AYUSH system-based contraindications. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: single arm,uncontrolled,pretest post test efficacy design: <br>Dasamoolakatutraya kashaya or Indhukantha kashaya or Vyagriyadhi kashaya Dose- 30 ml for children(6 -16 years),60ml for adults(17-60 years) twice daily. Duration- 15 days.<br>Followed by Agastya rasayana or Chyavanaprash or Kooshmanda rasayana Dose- 5gms for children,10 gms for adults, twice daily.Duration- 30 days.<br>Route of administration-Orally<br>Assessment of clinical symptoms,Assessment of Quality of Life on 30th day,45 th day and 60th day.<br>Blood investigations before and after intervention.<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | Relief from persistent symptoms if any assessed by clinical parameters and improvement in quality of life assessed by EuroQol visual analog scale.Laboratory assessment will be done at baseline and after Ayurveda intervention.Timepoint: Assessment on 30th day,45th day and 60th day.→ | | | | Yes | False | | |
| → | CTRI/2020/09/027974 | 27 January 2021 | Clinical Evaluation of Chyawanprash for the prevention of COVID-19 among Health Care Personnel . | Clinical Evaluation of Chyawanprash for the prevention of COVID-19 among Health Care Personnel â?? An open label, prospective Randomized controlled study | | Central Council for Research in Ayurvedic Sciences CCRAS | 22-09-2020 | 20200922 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47658 | Not Recruiting | No | | | | 15-10-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Dr Satyendra Kumar Sonkar→ | | Department of Medicine, KING GEORGES MEDICAL UNIVERSITY, Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003 → | satyendra.sonkar@gmail.com→ | 9307288648→ | KGMU ,Lucknow→ | Inclusion criteria: All healthcare professionals and staff of age group between 25 to 60 years willing to participate, negative for SARS- Cov-2 at screening,(tested by rt-PCR), at KGMU , without co-morbid condition with exposure/chance of exposure to COVID 19 positive cases. <br/ ><br> Who are willing to provide signed informed consent. <br/ ><br> High Risk Group- It includes doctors, nursing staff and other paramedical staff like attendant who are directly looking after and examining COVID patients. <br/ ><br>Low risk- other faculty members who are present in the institute but not visiting corona ward. <br/ ><br>→ | Exclusion criteria: Pregnant and lactating females. <br/ ><br>Immune compromised and co morbid condition cases. <br/ ><br>Laboratory confirmed COVID-19 with or without symptoms <br/ ><br>Known allergy to any of the medications used in this trial. <br/ ><br>Not willing to participate in the study. <br/ ><br>Subjects who are taking any other medicine as prophylaxis such as HCQ. <br/ ><br>→ | | Intervention1: Standard Preventive Regimen plus Ayurveda Rasayana (Chyawanprash): Standard Preventive Regimen for healthcare workers(Standard precaution, Hand hygiene, Personal protective equipment , Respiratory hygiene and cough etiquette.) and <br>Chyawanprash,<br>Dose, 12gm twice daily Ayurvedic Formulation will be assessed in separate drug trial studies with a randomized two arm parallel design as per protocol.<br><br><br>Control Intervention1: Standard care as per the Ministry of heath and family welfare guidelines for COVID19 and Updated: Standard Preventive Regimen for healthcare workers(Standard precaution, Hand hygiene, Personal protective equipment , Respiratory hygiene and cough etiquette.)<br><br><br><br><br>→ | Percentage of participants with SARS- Cov-2 positivity as estimated by RT-PCR of nasopharyngeal swab / Chemiluminiscence assay after 1 month of consuming Chyawanprash.Timepoint: Baseline, 7th day,15th day,and 30th day→ | | | | Yes | False | | |
| → | CTRI/2020/09/027944 | 27 January 2021 | An open label, prospective comparative study to evaluate the proposed therapy in adults with mild symptomatic COVID-19 patients receiving the standard treatment of COVID infection. | An open label, prospective comparative study to evaluate potential of the proposed therapy (Tablet Cefixime 200 mg/Tablet Ivermectin 12 mg/Tablet Montelukast 10mg/Syrup Ascoril LS 5 ml) in adults with mild symptomatic COVID-19 patients receiving the standard treatment (Tablet Cefixime 200 mg/Vitamin C, MVBC/Antacids) of COVID infection. - Add on therapy/COVID-19/2020 | | Public Health Department | 22-09-2020 | 20200922 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46392 | Not Recruiting | No | | | | 22-09-2020 | 30 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label | Phase 3 | India→ | Dr Dhananjay Lad→ | | CROM Premises Department, Building no. 2, Opp. Caculo Mall, St. Inez, Panaji → | laddhl@gmail.com→ | 9158592177→ | CROM Clinical Research & Medical Tourism Pvt. Ltd.→ | Inclusion criteria: 1.Patients of both Gender aged more than 18 years old. <br/ ><br>2.Willing and able to provide written informed consent. <br/ ><br>3.Patients with Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV2 / COVID) infection confirmed by RT Polymerase chain reaction (RT-PCR) test <br/ ><br>4.Currently hospitalized and requiring medical care for COVID-19 <br/ ><br>5.Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening <br/ ><br>→ | Exclusion criteria: 1.Subjects having less than 18 years of age <br/ ><br>2.Drug atopy subjects <br/ ><br>3.Private positive patients/ Truenaat positive/ Antigen positive <br/ ><br>4.Critical comorbities→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tab.Cefixime 200 mg<br>Tab.Ivermectin 12 mg<br>Tab.Montelukast 10 mg<br>Syp.Ascoril LS 5 ml: Tab.Cefixime 200 mg BD for 5 days<br>Tab.Ivermectin 12 mg OD for day 1<br>Tab.Montelukast 10 mg OD for 5 days<br>Syp.Ascoril LS 5 ml for 3 times a day for 5 days<br>Control Intervention1: Tablet Cefixime 200 mg<br>Vitamin C, MVBC, Antacids: Tablet Cefixime 200 mg BD for 5 days<br>Vitamin C, MVBC, Antacids (Pantoprazole 40 mg)<br>→ | Compared to standard of treatment receiving in COVID -19 infection, proposed regimen if consumed as an add on therapy prescribed by physician as per the clinical conditions and disease outcome will be efficacious in reducing medically attended lung infection caused by RT-PCR-confirmed COVID-19 virus in COVID Positive adults more than age 18 yrs .Timepoint: 14 Days→ | | | | Yes | False | | |
| → | CTRI/2020/09/027975 | 27 January 2021 | Utility of Medihope as an addon therapy for Covid 19 patients | Utility of Medihope as an addon therapy for Covid 19 patients: AnOpen labeled, Non-Randomized, Multicentric, Phase III Clinical. - NA | | HopeAyurvedic Medicine Pvt Ltd | 22-09-2020 | 20200922 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47748 | Not Recruiting | No | | | | 02-10-2020 | 880 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Double Blind Double Dummy | Phase 3 | India→ | Dr Rahul Kunkulol→ | | HOD Room Fifth Flor New RuralMedical College Building Loni Bk Tal Rahata→ | kalpesh.game@gmail.com→ | 9975716830→ | Rural Medical college Loni→ | Inclusion criteria: 1. Covid-19 patients diagnosed by RTPCR/ Rapid test, willing to participate and comply with all study procedures of the study. <br/ ><br>2. Patients with or without history of Diabetes and/or Hypertension. <br/ ><br>3. Patients willing to give written informed consent. <br/ ><br>4. Patients of age more than 18 years of either gender. <br/ ><br>5. Patients with mild (do not require oxygen, SpO2 100%) to moderate (require oxygen but do not require ventilatory support) symptoms of Covid-19 infection. <br/ ><br>→ | Exclusion criteria: 1. Patients with previous history of severe respiratory illness, viz Pneumonia, COPD. <br/ ><br>2. Patients requiring Ventilatory support. <br/ ><br>3. Pregnant and lactating women. <br/ ><br>4. Patients with any other acute or chronic illness, viz Crohns disease, Congestive cardiac failure, rheumatoid arthritis, AIDS. <br/ ><br>5. Patients receiving medication other than that for diabetes, hypertension. <br/ ><br>6. Patients receiving any medication of traditional medicine. <br/ ><br>7. Patients with history of allergy. <br/ ><br>8. Patients with any psychiatric illness or history of drug abuse. <br/ ><br>→ | Health Condition 1: J99- Respiratory disorders in diseasesclassified elsewhere
Health Condition 2: J99- Respiratory disorders in diseasesclassified elsewhere
→ | Intervention1: Medihope: Medihope is a patented Ayurvedic product whose individual components have been mentioned in Ayurvedic texts. None of the individual components belongs to the Schedule E (1) of the Drugs and Cosmetics Act, 1940<br>The above treatment as per Category of the patients with 1 scoop of medicine (6 grams) mixed in 1 glass of water twice in a day after Breakfast and after Dinner for 7 days in Mild Category patients and 15 days in Moderate Category patients.<br>Control Intervention1: NA An open labeled study: NA An open labeled study<br>→ | Primary:Chest radiograph, HRCT, SpO2 levels, Arterial Blood Gas and Status at discharge <br/ ><br>Secondary:temperature, respiratory symptoms and change in CBC, D-dimer, S. ferritin, IL-6, Vitamin D3, C-reactive protein, LDH, LFT, RFT & Duration of stay <br/ ><br>Timepoint: All the variables will be assessed at Day 1(baseline) and at Day 7 for the mild patients and day 15 for the moderate/severe patients <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/09/027993 | 27 January 2021 | Assessment of effect of COVID-19 on fatigue and exercise capacity in patients with Covid-19 treated at a government tertiary care hospital. | Impact of COVID-19 on fatigue and exercise capacity in patients treated at a municipal
tertiary care hospital dedicated to COVID-19 management | | Dr Chhaya Verma | 23-09-2020 | 20200923 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47645 | Not Recruiting | No | | | | 30-09-2020 | 75 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Anagha Mangaonkar→ | | Physiotherapy School and Centre, OPD no. 24, N Building, TNMC and BYLNCH, Dr. A. L. Nair Marg, Mumbai Central, Mumbai → | sayali.1009@gmail.com→ | 8983488293→ | Physiotherapy School and Centre, TNMC and BYLNCH, Mumbai→ | Inclusion criteria: 1)Adult Patients tested positive for COVID 19 on Reverse Transcriptase Polymerase Chain reaction (RT PCR) <br/ ><br>2)Stable Patients fulfilling the discharge criteria practiced by the hospital→ | Exclusion criteria: 1)Patients not willing to give consent <br/ ><br>2)Patients on immuno-compromising drugs <br/ ><br>3)Patients with cognitive impairment <br/ ><br>4)Patients with pre existing neuromuscular disorders→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Fatigue Assessment ScaleTimepoint: At baseline only→ | | | | Yes | False | | |
| → | CTRI/2020/09/027992 | 27 January 2021 | Investigator Initiated Study to Evaluate the Effectiveness and Safety of Thymosin α-1 (Tα1) in Moderate COVID-19 Patients | A Prospective, Single-Center,Two-Arm(Standard Control),Randomized Investigator Initiated Clinical Study to Evaluate the Effectiveness and Safety of Thymosin α-1 (Tα1) in Moderate COVID-19 Patients
| | Dr Om Shrivastava | 23-09-2020 | 20200923 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46389 | Not Recruiting | No | | | | 25-09-2020 | 20 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Dr Adarsh Shetty→ | | Gufic Biosciences Limited, Department of Regulatory Affairs, Subhash Road A Block Vile Parle East Mumbai MAHARASHTRA
India → | medicalaffairs@guficbio.com→ | 912267261000→ | Gufic Biosciences Limited→ | Inclusion criteria: 1.Male/females of â?¥ 18 years of age at the time of consent <br/ ><br>2.Patient who can and willing to provide written Informed Consent <br/ ><br>3 Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test /any other confirmatory tests <br/ ><br>4 Patient with pneumonia with no signs of severe disease <br/ ><br>5 If the patient presents any one of the following features: <br/ ><br>-Respiratory rate of â?¥â??24 breath/min <br/ ><br>-SpO2 (oxygen saturation) â?¤â??94% on room air <br/ ><br>6.Patient/ patientâ??s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements <br/ ><br>→ | Exclusion criteria: Male/females of â?¥ 18 years of age at the time of consent <br/ ><br>2 The patient who can and willing to provide written Informed Consent <br/ ><br> Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection <br/ ><br>confirmed by polymerase chain reaction (PCR) test /any other confirmatory tests <br/ ><br>4. Patient with pneumonia with no signs of severe disease <br/ ><br>5. If the patient presents any one of the following features: <br/ ><br>- Respiratory rate â?¥ 24 breath/min to < 30 breath/min <br/ ><br>- SpO2 (oxygen saturation) >90% to â?¤ 94% on room air <br/ ><br>6. Patient/ patientâ??s LAR understands and is willing to participate in the clinical <br/ ><br>study and can comply with clinical trial protocol requirements <br/ ><br>The patient who has participated in another trial with an investigational drug within 1 <br/ ><br>a month prior to this trial. <br/ ><br>Patients who, in the judgment of the investigator will be unlikely to comply with <br/ ><br>the requirements of this protocol→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Immunocin α 1.6 mg: Two subcutaneous injections of 1.6 mg Tα1 twice daily for seven consecutive days.<br>Control Intervention1: SOC alone <br><br>: 2 subcutaneous injections of 1.6 mg Tα1 twice daily along with SOC<br>→ | 1.Duration of ICU stay [from baseline to End of study (Day 7)] <br/ ><br>2.Ventilator duration [from baseline to End of study (Day 7)] <br/ ><br>3.Incidences of all-cause hospital mortality [ Time Frame: From date of Drug <br/ ><br>administered until the date of hospital discharge or date of death from any cause, <br/ ><br>whichever came first, assessed up to 28 days] <br/ ><br>4.Duration of hospitalization [ from baseline to hospital discharge]Timepoint: 1.Day 1 to Day 7 <br/ ><br>2.Day 1 to Day 7 <br/ ><br>3.Day 1 to Day 28 <br/ ><br>4.Day 1 to Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/09/028007 | 27 January 2021 | Prophylactic study of Ashwagandha and HCQ in health care providers | Ashwagandha for the Prophylaxis against SARS-COV-2 Infection: A Randomized Hydroxychloroquine Controlled Clinical Trial in Health Care Providers | | CSIR Ministry of Ayush | 23-09-2020 | 20200923 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47763 | Not Recruiting | No | | | | 03-10-2020 | 400 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Anand More→ | | All India Institute of Ayurveda Mathura Road Sarita Vihar Delhi-110076 Academic Block ,Department of Roga Nidana 3rd floor room no.-305 → | drmoreanand@gmail.com→ | 9422025732→ | All India Institute of Ayurveda→ | Inclusion criteria: 1)Participants of either sex,20 to 69 years of age <br/ ><br>2)Participants tested negative COVID-19 by nose throat swab using PCR technique <br/ ><br>3)Participants should be naive for HCQ <br/ ><br>4)Willing to come for regular follow-up visits <br/ ><br>5)Written informed consent→ | Exclusion criteria: 1)Individuals with known hypersensitivity or Intolerance and contraindications (psoriasis, porphyria and Glucose-6-Phosphate Dehydrogenase deficiency) <br/ ><br>2)Pregnant women, lactating women and women of child bearing potential. hypersensitivity orIntolerance to Hydroxychloroquine will not be assigned to HCQ intervention arms in Group A and Group B Contraindications to HCQ use such as psoriasis, porphyria, and Glucose-6-phosphate dehydrogenase (G6PD) deficiency <br/ ><br> <br/ ><br>3)Individuals with known allergy or contraindication to Ashwagandha <br/ ><br> <br/ ><br>4)Have any Chronic, Severe, Unstable, Uncontrolled medical disease such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the participant at increased risk during the study <br/ ><br>5)History of having received any investigational drug in the preceding one month. <br/ ><br> <br/ ><br>6)Prolonged concurrent intake of any drug that is known to prolong QT interval on the ECG as per physician discretion and these drugs include anti-arrhythmic drugs, quinidine, chlorpromazine, haloperidol, olanzapine, thioridazine, fluoxetine, antibiotics belonging to quinolone and macrolide family, antibiotics, fenfluramine and other appetite suppressants, Beta-2 agonists, terfenadine and other <br/ ><br>anti-hitaminic drugs, liquorice and potassium lowering drugs <br/ ><br>7)History of taking any kind of Ayurvedic formulation or any other form of CAM (Complimentary Alternative Medicine) therapy in the preceding 2 months <br/ ><br>8)Unwilling to come for regular follow-up for the entire duration of the study. <br/ ><br>9)Non â?? co-operative attitude of the participant <br/ ><br>10)Any condition that, in the opinion of the investigator, does not justify the <br/ ><br>participantâ??s inclusion in the study. <br/ ><br>→ | | Intervention1: Ashwagandha (Withania somnifera: Ashwagandha has immunomodulant and immune enhancing activity. It is anti oxidant and promotes health 250 mg, 2 tablets twice a day for 12 weeks<br>Control Intervention1: Hydroxychloroquine: HCQ is considered to be anti viral and anti inflammatory. 400 mg tablet. 400 mg tablet twice a day on Day 1, 400 mg once a week for 7 weeks<br>→ | (i)Proportion of SARS-CoV-2 infection free participants on completion of study (ii)Proportion of participants contracting COVID-19 during the study periodTimepoint: 1)Baseline <br/ ><br>2)4 Week <br/ ><br>3)8 Week <br/ ><br>4)12 Week→ | | | | Yes | False | | |
| → | CTRI/2020/09/028045 | 27 January 2021 | Online learning programme for providing cardiopulmonary resuscitation among Nurses | Pilot Testing of Enhancement Training Module on Cardiopulmonary Resuscitation in COVID 19 Patients for Nurses Working in AIIMS, New Delhi on an e-learning Platform | | Poonam Joshi | 24-09-2020 | 20200924 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44046 | Not Recruiting | No | | | | 28-09-2020 | 100 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | POONAM JOSHI→ | | ROOM NO 5, COLLEGE OF NURSING, AIIMS → | pjoshi495@gmail.com→ | 9818039744→ | ALL INDIA INSTITUTE OF MEDICAL SCIENCES→ | Inclusion criteria: Nurses who have undergone CPR training as per IRC guidelines <br/ ><br>Willing to participate in study <br/ ><br>scores more than 80% marks in the screening test→ | Exclusion criteria: Nurses not accessible/ contactable during the study period (on long leave, left the institute) <br/ ><br>→ | | Intervention1: Enhancement Training Module on CPR guidelines related to COVID 19: Online training will be provided to the nurses in which they will be updated with new CPR guidelines in context to COVID-19<br>Control Intervention1: Not applicable: Not applicable<br>→ | Knowledge ScoreTimepoint: baseline, one week→ | | | | Yes | False | | |
| → | CTRI/2020/09/028044 | 27 January 2021 | Phase IV study to evaluate the safety and efficacy of Artemisinin- a herbal supplement on COVID-19 subjects | A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19 | | Windlas Biotech Private Limited | 24-09-2020 | 20200924 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47432 | Recruiting | No | | | | 30-09-2020 | 120 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 4 | India→ | Mukesh Kumar→ | | Department of Regulatory Affairs, Khasra no. 141 to 143
and 145,Mohabewala, Industrial Area → | antaryami@abiogenesisclinpharm.com→ | 914038117077→ | Abiogenesis Clinpharm Private Limited→ | Inclusion criteria: 1.Male or female subjects of â?¥18 to 60 years of age both inclusive <br/ ><br>2.Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures <br/ ><br>3.Confirmed case of COVID-19 infection by RT-PCR and mild and moderate (without oxygen therapy or assisted ventilation) cases of COVID-19. Scores of 2-4 on the WHO Clinical Progression Scale <br/ ><br>4.Time interval between symptoms onset and randomization of no more than 7 days <br/ ><br>5.One or more of the following symptoms: <br/ ><br> Fever <br/ ><br> Cough <br/ ><br> Sore throat <br/ ><br> Headache <br/ ><br> Nasal congestion <br/ ><br> Malaise <br/ ><br> Diarrhea <br/ ><br> Loss of smell <br/ ><br> Loss of taste <br/ ><br>6.Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active. <br/ ><br>→ | Exclusion criteria: 1. Subjects with history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening <br/ ><br>2. Known or suspected hypersensitivity to Artemisinin <br/ ><br>3. Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study <br/ ><br>4. Men who are unwilling to use contraception while receiving investigational product <br/ ><br>5. Subjects with history of severe disease other than COVID-19 which is expected to prevent compliance with the present protocol <br/ ><br>6. Subjects with history of severe renal and hepatic impairment. (creatine â?¥2 mg/dl; liver enzymes and bilirubin 2.5 times ULN; alkaline phosphatase 1.5 times ULN) <br/ ><br>7. Recent treatment with Artemisinin or Artemisinin based antimalarials in the past 7 days <br/ ><br>8. Known history of failure to control systemic fungal, bacterial or viral infection <br/ ><br>9. Patients with the history of following co-morbidities: diabetes, hypertension with or without cardiac symptoms, morbid obesity with diabetes and/or hypertension or any other metabolic syndrome <br/ ><br>10. Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection <br/ ><br>11. Have a history of neurological or psychiatric disorders, including epilepsy or dementia <br/ ><br>12. Subjects for whom ventilator support is required at screening <br/ ><br>13. Patients not willing to stay in hospital for 5 days of isolation following diagnosis of Covid-19 <br/ ><br>14. Subjects not willing to give their informed consent to participate in the clinical trial <br/ ><br>15. According to the investigator judgment there are concomitant diseases with a serious safety hazard or affect the subject <br/ ><br>16. Using other experimental drugs or participating in other clinical trials in the prior one month→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Artemisinin 500mg capsule: Oral administration of Artemisinin 500 mg capsule/day for 5 days + SOC per cycle with the option to repeat as needed until disease is resolved or subject is discharged, up to a total of consecutive 3 cycles (â??5 days treatment, 5 days off" comprises a cycle).SOC is Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)<br>Intervention2: Artemisinin 500 mg capsule: The dose regimen will be in cycles. In a cycle a subject will receive Artemisinin 500 mg capsule once daily plus SOC on Day 1 to Day 5 followed by 5 days off (no dosing of Artemisinin) or SOC alone. A subject can have a total of consecutive 3 cycles maximum. Here SOC is Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)<br>Control Intervention1: SOC: Standard of Care as per CLINICAL MANAGEMENT PROTOCOL: COVID-19, Government of India Ministry of Health and Family Welfare Directorate General of Health Services (EMR Division)<br>→ | Safety Assessments <br/ ><br>- Adverse events (AEs) during the study <br/ ><br>- Serious adverse events (SAEs) during the studyTimepoint: Day 28→ | | | | Yes | False | | |
| → | CTRI/2020/09/028043 | 27 January 2021 | Clinical study to assess role of Vasa Ghana, Guduchi Ghana and Vasa-Guduchi
Ghana in therapeutic management of symptoms in Covid19 | A Prospective, Randomized, Open label Three Armed Clinical study to assess the role of
Vasa Ghana(whole Aqueous extract of Adhatoda vasica), Guduchi Ghana (whole Aqueous
extract of Tinospora cordifolia) and Vasa-Guduchi Ghana (whole Aqueous extract of
Adhatoda vasica &Tinospora cordifolia combined) in management of symptoms and
preventing the progression of severity of the disease in SARS-CoV2 tested positive
asymptomatic and mild COVID-19 cases | | Ministry of AYUSH Govt of India | 24-09-2020 | 20200924 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47443 | Not Recruiting | No | | | | 21-09-2020 | 50 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Open Label | Phase 4 | India→ | Dr Meera K Bhojani→ | | Room No. 302 , 3rd floor Academic block , All India Institute of Ayurveda , New Delhi → | bhavana.p@igib.res.in→ | 9899107338→ | CSIRâ??s Ayurgenomics Unit- IGIB→ | Inclusion criteria: People who have been tested positive to be infected with SARS-CoV2 virus and <br/ ><br>presenting with no symptoms or mild symptoms <br/ ><br> Voluntariness to participate in the trial <br/ ><br> Patients who are able to take the drug orally and comply with study procedures. <br/ ><br> Women of childbearing potential must have a negative urine pregnancy test prior to <br/ ><br>study entry. <br/ ><br> Age 19-65 years→ | Exclusion criteria: COVID patients with symptoms classified as moderate, severe or critical. Patients <br/ ><br>suffering from severe COVID-19 disease as judged by a physician and fulfilling <br/ ><br>at least two of the following three criteria: <br/ ><br> Respiratory distress at room ambience (â?¥30 breaths per min) <br/ ><br> SaO2/ SpO2 < 90% on room air and requiring oxygen support for more <br/ ><br>than one hour to normalize. <br/ ><br> PaO2/ FiO2 < 300 mmHg. <br/ ><br> Any of the known COVID-19 complications and emergency procedures <br/ ><br>which may require shift/admission in intensive care unit such as <br/ ><br>respiratory failure, adult respiratory distress syndrome, requirement of <br/ ><br>oxygen support for more than 1 hour, requirement of mechanical <br/ ><br>ventilation, septic shock, or severe non-respiratory organ dysfunction or <br/ ><br>failure. (Adapted and modified from the reference: Yang Liu et al. Lancet <br/ ><br>Infect Dis 2020, 2020 https://doi.org/10.1016/ S1473-3099(20)30232-2) <br/ ><br>Individuals with uncontrolled, unstable co-morbidities/ co-existent medical illness <br/ ><br>such as diabetes, hypertension, cardiac disorders, liver, kidney disorders and lung <br/ ><br>disorders or other disease of concern that may put the patient at increased risk <br/ ><br>during the study. <br/ ><br>Persons with serious complications of diseases such as cancer, heart disease, stroke, <br/ ><br>disabilities, mental illnesses, etc. and who are considered to be excluded from the <br/ ><br>study as evaluated by the investigators. <br/ ><br>Individuals with pre-existing respiratory conditions <br/ ><br>Immuno-compromised individuals or those on immune suppressants. History of <br/ ><br>immune suppression: solid organ or bone marrow transplant, use of immune <br/ ><br>suppressive anti-metabolic and biologic agents, intrinsic immune deficiencies, HIV <br/ ><br>infection. <br/ ><br>Patients on or requiring parenteral nutrition <br/ ><br>Patients with known sensitivity or contraindication to any of the study medication. <br/ ><br>Pregnant and lactating females <br/ ><br>Patients who are likely to worsen or planed ICU admission or ventilator support <br/ ><br>due to any reason. <br/ ><br>COVID-19 positive cases participating as subjects in the interventional arm of <br/ ><br>other COVID-19 clinical trials. <br/ ><br>Participation in a drug interventional clinical drug trial of any nature in the three <br/ ><br>month period preceding onset of COVID-19. <br/ ><br>Patients on any kind of Ayurveda treatment or any other alternative and <br/ ><br>complementary medicinal systems such as Homeopathy, Unani, Siddha and in <br/ ><br>particular requiring oral therapy of any kind. <br/ ><br>Physician decision that involvement in the study is not in the patient´s best interest. <br/ ><br>Patient with persistent vomiting more than three episodes of vomiting in 12 hours, <br/ ><br>preventing adequate oral hydration. <br/ ><br>Patient with known active hepatitis, and definite bacterial or fungal infections. <br/ ><br>Patient with altered mental state. <br/ ><br>Patient taking concomitant medication associated with QTc-interval prolongation, <br/ ><br>which cannot be withdrawn prior to study drug administration. <br/ ><br>Patient with history of evidence of chronic interstitial infiltration at imaging. <br/ ><br>Patient with history of serology tests positive for hepatitis B, hepatitis C, or human <br/ ><br>immune deficiency virus.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayurvedic: Vasa-Guduchi<br>Ghana (Aqueous extract of Adhatoda vasica Tinospora cordifolia combined)<br>Intervention2: Ayurvediic: Guduchi Ghana (Aqueous extract of Tinospora cordifolia)<br>Intervention3: Guduchi Ghana (Aqueous extract of Tinospora cordifolia): <br>The Asymptomatic OR/and Mild symptomatic COVID19 RT-PCR swab test<br>positive will be administered Guduchi Ghana (whole water soluble extract): 500mg BD<br>15 min. before meals for 14 days<br>Intervention4: Vasa Ghana (Aqueous extract of Adhatoda<br>vasica),: <br> The Asymptomatic OR/and Mild symptomatic COVID19 RT-PCR swab test<br>positive will be administered Vasa Ghana (whole water soluble extract): 500mg BD 15<br>min. before meals<br>for 14 days<br>Intervention5: Vasa- Guduchi Ghana (whole water soluble extract):<br>500mg (250 mg each of Vasa and Guduchi): The Asymptomatic OR/and Mild symptomatic COVID19 RT-PCR swab test<br>positive will be administered Vasa- Guduchi Ghana (whole water soluble extract):<br>500mg (250 mg each of Vasa and Guduchi) BD 15 min. before meals for 14 days<br>→ | Length of time to clinical improvement/disease progression <br/ ><br>Duration of fever and respiratory symptoms <br/ ><br>Incidence of respiratory failure <br/ ><br>Number of days of treatment and hospitalization <br/ ><br>Requirement of SOS medication- reason and no.of times <br/ ><br>Requirement of Rescue medication <br/ ><br>Percent mortality <br/ ><br>Adverse events <br/ ><br>Percent mortality <br/ ><br>Changes in all the Lab parametersTimepoint: Length of time to clinical improvement/disease progression <br/ ><br>Duration of fever and respiratory symptoms <br/ ><br>Incidence of respiratory failure <br/ ><br>Number of days of treatment and hospitalization <br/ ><br>Requirement of SOS medication- reason and no.of times <br/ ><br>Requirement of Rescue medication <br/ ><br>Percent mortality <br/ ><br>Adverse events <br/ ><br>Percent mortality <br/ ><br>Changes in all the Lab parameters→ | | | | Yes | False | | |
| → | CTRI/2020/09/028040 | 27 January 2021 | Seroprevalence of COVID 19 in children | Sero-prevalence and Clinical profile of SARS-CoV-2 infection in children - Covid 19 kids | | CTMRF KKCTH | 24-09-2020 | 20200924 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47809 | Not Recruiting | No | | | | 05-10-2020 | 400 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Aishwarya Venkataraman→ | | Department of Paediatrics
Kanchi Kamakoti CHILDS Trust Hospital (KKCTH)
12 A Nageswara Road, Nungambakkam
Chennai, Tamil Nadu, India 600034. DBT Ramalingaswami fellow
Department of HIV AIDSICMR - National Institute for Research in Tuberculosis (NIRT),
N→ | draishwaryav@gmail.com→ | | Kanchi Kamakoti CHILDS Trust Hospital (KKCTH)→ | Inclusion criteria: All children between 1 month and 18 years→ | Exclusion criteria: Caretakers and children unwilling to participate <br/ ><br>Children in whom blood draw is not justified eg anaemia→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. Proportion of children with seropositivity for SARS-CoV-2 infection <br/ ><br>2. Proportion of asymptomatic children with positive COVID 19 <br/ ><br>3. Proportion of children who show symptoms or signs of COVID-19 infection <br/ ><br>4. Proportion of children with PIMS-TSTimepoint: baseline→ | | | | Yes | False | | |
| → | CTRI/2020/09/028046 | 27 January 2021 | Homoeopathy management for covid 19 patients | Homoeopathy as an adjuvant to standard treatment protocol in management of corona virus infection- a randomised, placebo controlled, open label study. | | Central Council for Research in Homeopathy Ministry Ministry of Ayush | 24-09-2020 | 20200924 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45038 | Not Recruiting | No | | | | 05-10-2020 | 100 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label | N/A | India→ | Dr Sushma Bhtanagar→ | | Room 242, 2nd Floor, Dr. B.R.A. IRCH, All India Institute of Medical Sciences (AIIMS) Ansari Nagar Ansari Nagar, New Delhi-110029→ | sushmabhatnagar1@gmail.com→ | 01129575209→ | All India Institute of Medical Sciences (AIIMS)→ | Inclusion criteria: Patients with corona virus infection reporting at Hospital, with all the following shall be included: <br/ ><br>1. Laboratory confirmed cases of Corona virus infection. <br/ ><br>2. Age 18 years to 80 years and both gender <br/ ><br>3. Willing to give signed written informed consent <br/ ><br>→ | Exclusion criteria: 1. Patients on ventilatory support <br/ ><br>2. Immunocompromised patients <br/ ><br>3. Severe heart, lung, kidney, brain, blood diseases or other important systemic diseases <br/ ><br>4. Subjects considered to be unable to complete the study, or not suitable for the study by researchers. <br/ ><br>5. Women during pregnancy; <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J708- Respiratory conditions due to other specified external agents
→ | Intervention1: Homoeopathic medicines: Homoeopathic medicines in dilutions of centesimal potency (30C, 200C, and 1M) for the trial shall be procured from any of the approved Good Manufacturing Practices (GMP) firms.<br>Globules/pills of size 30 shall be used for medicating dilutions and dispensing alcohol shall be used for preparing placebo resembling the medicine. These globules shall be procured from same firms. One dose will constitute 4 globules moistened with the medicine or placebo. <br>Investigator/ pharmacist will dispense the homoeopathic medicine/placebo to the patients as per the randomization chart provided to him/her. <br><br>Control Intervention1: Globules PILLS: Globules/pills of size 30 shall be used for medicating dilutions and dispensing alcohol shall be used for preparing placebo resembling the medicine. These globules shall be procured from same firms. One dose will constitute 4 globules moistened with the medicine or placebo.<br>→ | To compare the effectiveness of homoeopathic treatments an adjuvant to the standard treatment protocol in corona virus infection.Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/09/028049 | 27 January 2021 | Evaluation of Atypical imaging features on HRCT CHEST. | Atypical imaging on HRCT CHEST in patients of a dedicated COVID HOSPITAL of ODISHA - A prospective study | | Rohit Arora | 25-09-2020 | 20200925 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46447 | Not Recruiting | No | | | | 20-10-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Investigator Blinded | N/A | India→ | Rohit Arora→ | | Department of Radiodiagnosis, KIMS, Kushabhadra Campus , KIIT Campus, 5, KIIT Road, Patia, Bhubaneswar, Odisha 751024 Department of Radiodiagnosis, KIMS,Kushabhadra Campus , KIIT Campus, 5, KIIT Road, Patia, Bhubaneswar, Odisha 751024→ | kamal.sen@kims.ac.in→ | 7064333377→ | Kalinga Institute of Medical Sciences→ | Inclusion criteria: COVID 19 positive patients with Atypical HRCT imaging features on admission/discharge. <br/ ><br> <br/ ><br>→ | Exclusion criteria: Clinically suspected COVID 19 cases which remained negative on RT-PCR testing. <br/ ><br> <br/ ><br>Those COVID positive patients, who have not undergone HRCT Chest or contrast studies if indicated. <br/ ><br> <br/ ><br>HRCT Chest with typical COVID features as per available classification. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Evaluate the prevalence of the atypical imaging features amongst our study groupTimepoint: 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/09/028050 | 27 January 2021 | Intubation and ventilatory support in COVID patients: observational study from a tertiary care ICU. | Intubation in COVID patients: a prospective observational study from a tertiary care ICU. | | AIIMSNew Delhi | 25-09-2020 | 20200925 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47764 | Not Recruiting | No | | | | 02-10-2020 | 40 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | N/A | India→ | Dr Nishant Patel→ | | Room No 5013,Department of anaesthesiology
fifth floor
Teaching block
AIIMS,New Delhi → | pateldrnishant@gmail.com→ | | AIIMS,New Delhi→ | Inclusion criteria: 1.All patients which undergo intubation in ICU will be included in this study→ | Exclusion criteria: 1.Intubated patients shifted to our centre from other hospitals/centre→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J129- Viral pneumonia, unspecified
→ | | The time taken from admission to tracheal intubation ( days)Timepoint: Baseline at the the time of admission,The day of tracheal intubation→ | | | | Yes | False | | |
| → | CTRI/2020/09/028084 | 27 January 2021 | Effects of Traditional Nasal Saline (Simply Saline) and a Novel Nasal Salt on Aerosol Cleansing | Nasal Calcium Salts for Clearing Exhaled Bioaerosols in healthy volunteers and in asymptomatic and midly symptomatic SARS COV 2 patients | | Bangalore Baptist Hospital | 28-09-2020 | 20200928 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47137 | Not Recruiting | No | | | | 05-10-2020 | 80 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant Blinded | N/A | India→ | Dr Carolin Elizabeth George→ | | Community Health Department
4th floor, Room No:01, Asha block, Bangalore Baptist Hospital
Bellary road, Hebbal, Bengaluru → | carolinelizabethj@gmail.com→ | 9972156838→ | Bangalore Baptist Hospital→ | Inclusion criteria: Phase1: <br/ ><br>. Health care workers or the general public <br/ ><br>. Willing for nasal spray treatment <br/ ><br> <br/ ><br>Phase2: <br/ ><br>Asymptomatic or mild COVID case with a Positive nasopharyngeal swab for SARS-Cov-2 (RT-PCR) not more than two weeks→ | Exclusion criteria: Phase1: <br/ ><br>Any symptoms suggestive of SARS-Cov-2 <br/ ><br> <br/ ><br> <br/ ><br>Phase2: <br/ ><br> <br/ ><br>. Nasal spray administered less than 12 hours <br/ ><br> before the study <br/ ><br>. active treatment with medications with a <br/ ><br> known side effect of dry mouth <br/ ><br>. current or prior mucosal head and neck <br/ ><br> cancer treatment, <br/ ><br>. acute or chronic upper aerodigestive tract <br/ ><br> infection, <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nasal mist calcium salts: 100 mg through Nasal administration once for 5 minutes<br>Control Intervention1: Normal Saline: 100 mg through Nasal administration once for 5 minutes<br>→ | Exhaled bioaerosol count (particles per liter of air)Timepoint: Exhaled bioaerosol count (particles per liter of air)@ 15,30,45 minutes and 1Hr→ | | | | Yes | False | | |
| → | CTRI/2020/09/028090 | 27 January 2021 | Social factors related to COVID 19 | Living conditions, social determinants and experiences of COVID-19 infection among employees at a tertiary-referral cancer centre â?? A mixed methods study | | Not applicable | 28-09-2020 | 20200928 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47924 | Not Recruiting | No | | | | 07-10-2020 | 800 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sandeep Tandon→ | | Department of Pulmonary Medicine, Room number 304,
Golden Jubilee Building
Tata Memorial Hospital
Parel, Mumbai, India → | sptandon@gmail.com→ | 24177000→ | Tata Memorial Hospital→ | Inclusion criteria: 1. Employee of Tata Memorial Hospital (permanent or contract) <br/ ><br>2. Who test positive for COVID-19 and recover from infection <br/ ><br>3. Who give consent to participate in the study <br/ ><br>4. Who can understand English, Hindi or Marathi <br/ ><br>→ | Exclusion criteria: Refusal of consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | Socio-economic factors associated with COVID-19Timepoint: 30 days before COVID-19 infection→ | | | | Yes | False | | |
| → | CTRI/2020/09/028069 | 27 January 2021 | Variation in biochemical parameters in COVID-19 infection | Role of biochemical markers in COVID-19 infection | | Sri Ramachandra Institute of Higher Education Research Institute SRIHERDU | 28-09-2020 | 20200928 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47703 | Not Recruiting | No | | | | 01-10-2020 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | S Sowmiya→ | | Department of Biochemistry
SRIHER
No: 1 Ramachandra Nagar Porur Chennai→ | ksowmya@sriramachandra.edu.in→ | | Sri Ramachandra institute of Higher Education & Research, SRIHER(DU)→ | Inclusion criteria: o Data of Individuals tested with Positive RT- PCR/ viral nucleic acid test for COVID-19 will be accessed <br/ ><br>o Patients Presenting with mild / No symptoms (Isolation ward participants data will be accessed) <br/ ><br>o Patients Presenting with moderate/ severe symptoms of COVID â?? 19 (ICU participants data will be accessed) <br/ ><br>→ | Exclusion criteria: Following Records of investigations will not be accessed: <br/ ><br>o Data of Individuals with Liver disease, Rheumatoid arthritis, Renal disease & cardiac disease will not be accessed. <br/ ><br>o Reports presenting with any other bacterial infections will not be accessed <br/ ><br>o Reports of Pregnant women and age below <18 yearâ??s will not be considered. <br/ ><br>o Data of Patients presenting with dengue, malaria infections will not be acquired. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To understand the biochemical alterations and prognosis of the COVID â?? 19 pandemic infectionTimepoint: 6 - 7 months→ | | | | Yes | False | | |
| → | CTRI/2020/09/028085 | 27 January 2021 | Coping methods of stress among frontline Healthcare workers
| Coping Strategies among Healthcare Providers directly involved in covid-19 care: A Cross-sectional study
| | no sponser | 28-09-2020 | 20200928 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47774 | Not Recruiting | No | | | | 05-10-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Yudhyavir Brahmachari→ | | Department of Anaesthesiology, Pain Medicine and Critical Care
Room 5011, %th floor
Teaching Block
AIIMS , Ansari Nagar East Room NO. 312, third floor
Jai Prakash Narayan Apex Trauma Centre
New delhi
→ | yudhyavir@gmail.com→ | 9811140057→ | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: 1) Healthcare workers involved in direct care of patients with covid 19 disease. <br/ ><br>2) Age >18 years and <60 years <br/ ><br>3) No h/o prior psychiatric illness <br/ ><br>→ | Exclusion criteria: 1) Healthcare workers not involved in direct care of patients with covid 19 disease. <br/ ><br>2) H/o prior psychiatric illness <br/ ><br>→ | | | The primary objective is to identify Frontline healthcare workers having difficulty coping with stress related to Covid 19 <br/ ><br> Timepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/09/028087 | 27 January 2021 | Evaluation of severity of chest CT findings in covid 19 patients with pre-existing illness | Evaluation of HRCT chest manifestation in COVID 19 patients with pre-existing comorbidity. | | KIMS Hospital | 28-09-2020 | 20200928 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47816 | Not Recruiting | No | | | | 20-10-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Swati Das→ | | Department of Radiology, KIMS Hospital,Patia, Bhubaneswar Department of Radiology, KIMS Hospital,Patia, Bhubaneswar→ | swati.das@kims.ac.in→ | 9205569267→ | KIMS Hospital→ | Inclusion criteria: All the COVID positive patients admitted to Odisha COVID hospital, KIMS. with positive HRCT chest features.→ | Exclusion criteria: Patients who have not undertaken RT-PCR and HRCT thorax.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To assess the degree of severity of HRCT chest manifestation in COVID patients with pre-existing comorbidity.Timepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/09/028086 | 27 January 2021 | Effect of 12-weeks of Online Sudarshan Kriya Yoga practice on Burnout and Health Parameters among COVID-19 Frontline Warriors. | Efficacy of Sudarshan Kriya Yoga (SKY) based 12 weeksâ?? Online Breath and Meditation Workshop on change in Burnout and Ballistocardiography (BCG) assessments among Medical Professionals at a Tertiary Care Hospital during COVID-19 Pandemic: A Single Arm Trial. | | All India Institute of Medical Sciences Rishikesh | 28-09-2020 | 20200928 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47819 | Not Recruiting | No | | | | 08-10-2020 | 43 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable | N/A | India→ | Dr Monika Pathania→ | | Dept. of General Medicine, AIIMS, Rishikesh → | anshupathania27@gmail.com→ | 8126021556→ | All India Institute of Medical Sciences Rishikesh→ | Inclusion criteria: Medical Professionals working at AIIMS Rishikesh for at least 6 months <br/ ><br>Within age group of 18 to 65 years <br/ ><br>Willing to commit to at least 75% of total intervention period <br/ ><br>Having a smartphone device to avail online intervention along with at home practice sessions <br/ ><br>→ | Exclusion criteria: Already practicing yoga/meditation/stress reduction technique for more than 1 month in the previous 6 months <br/ ><br>Unable to practice yoga due to: musculoskeletal disorders, severe cervical pain, severe back pain or arthritis <br/ ><br>Having medical conditions like epilepsy, migraine, or any psychiatric disorder <br/ ><br>Pregnant women <br/ ><br>Not willing to provide a written informed consent <br/ ><br>→ | | Intervention1: Sudarshan Kriya Yoga (SKY) based 12 weeksâ?? Online Breath and Meditation Workshop: The 12-week long intervention will be having 3 main components:<br>1. Online 4-day Sudarshan Kriya Yoga (SKY) based Breath and Meditation Workshop for initiation to SKY practice<br>2. Daily SKY practice at home using mobile application for 12 weeks<br>3. Weekly follow-up sessions for 12 weeks<br><br>The initial online Sudarshan Kriya Yoga (SKY) based Breath and Meditation Workshop will be led by an Art of Living Teacher/Instructor. It will last for 4 days with 2 hours spent per day and will consist of interactive sessions, knowledge sharing, and initiation to SKY with practical demonstration along with home going instructions for daily practice at home. Daily home SKY practice session will be of 30 minutes each and will be led by PI/Co-PI/research-staff using a smartphone app installed on the participantâ??s device. In the weekly long SKY follow up sessions, participants will undergo group SKY sessions of longer duration than daily practice and will get an opportunity to express their views regarding the practice and provide feedback about the course and experiences felt during the practice. During each weekly follow up session, regular practice of SKY will be reinforced and participantâ??s compliance to daily practice will be checked. Any doubts regarding the practice of SKY and/or using the mobile app will also be clarified during weekly sessions. Intervention will be provided in groups of 5 participants at a time. A minimum of 75% adherence to the intervention will be required from the participants to qualify for final assessment.<br>Control Intervention1: Not Applicable (single Arm Trial): Not Applicable<br>→ | Burnout Scores (using 22-item Maslach Burnout Inventory Human Services Survey for Medical Personnel) [MBI-HSS (MP)]Timepoint: Baseline (after participant enrollment) <br/ ><br>Endpoint (after 12 weeks of intervention)→ | | | | Yes | False | | |
| → | CTRI/2020/09/028088 | 27 January 2021 | Open Label Randomized trial of Colchicine, Aspirin and Montelukast in Covid-19 | Open Label Randomized trial of Colchicine, Aspirin and Montelukast for prevention of Adult Multisystem Inflammatory Syndrome in SARS-CoV-2 patients - CAM-Covid-19 | | Vivek Chauhan | 28-09-2020 | 20200928 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47829 | Not Recruiting | No | | | | 31-10-2020 | 34 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | N/A | India→ | Vivek Chauhan→ | | Unit 1, Department of Medicine, IGMC SHIMLA → | drvivekshimla@yahoo.com→ | 9418341202→ | IGMC Shimla→ | Inclusion criteria: Diagnosis of SARS-CoV-2 admitted in our tertiary care hospital in Shimla with an oxygen saturation of <90% on room air→ | Exclusion criteria: o Patients unwilling to provide consent for the drug regimen. <br/ ><br>o Patients who die within 48 hours of admission in our hospital. <br/ ><br>o Patients having GFR < 30 or Severe Asthma or Severe COPD <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | Intervention1: Colchicine, Aspirin and Montelukast: Intervention: The intervention arm will receive, in addition to the standard of care, the following drugs:<br> Colchicine - 0.6 mg per oral, 12 hourly till discharge<br> Aspirin - 325 mg per oral 6 hourly till discharge<br> Montelukast - 10 mg per oral once a day till discharge<br><br>Control Intervention1: Standard of Care: Standard of Care in Covid-19<br>→ | Primary Outcome: Change in the marker of Adult Multi-system Inflammatory Syndrome i.e. C-reactive Protein <br/ ><br>Secondary Outcomes: Change in other markers of AMIS (Ferritin, D-dimer), Need for Ventilation (invasive or non-invasive), Mortality, Duration of Hospital Stay, Change in CT severity score at 1 month. <br/ ><br>Timepoint: 4 month→ | | | | Yes | False | | |
| → | CTRI/2020/09/028089 | 27 January 2021 | Role of self sampling in COVID 19 patients | A prospective diagnostic study for detection of Covid 19 in Self samples of RTPCR Covid 19 positive patients and their close contacts. | | AIIMS Rishikesh | 28-09-2020 | 20200928 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47832 | Not Recruiting | No | | | | 05-10-2020 | 1350 | Observational | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | N/A | India→ | Dr Amit Kumar→ | | Department of Otorhinolaryngology
AIIMS Rishikesh → | dramit4111@gmail.com→ | 9501666365→ | AIIMS Rishikesh→ | Inclusion criteria: 1. Age >18 years <br/ ><br>2. Proven Covid 19 patient by RT PCR assay <br/ ><br>→ | Exclusion criteria: 1. Patients with suspected Covid 19 patient but negative report on RT-PCR testing. <br/ ><br>2. <18 years <br/ ><br>3. Pregnant or breastfeeding females <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | | Comparison of mid-turbinate swab/self-sample AND nasopharyngeal swab/healthcare worker sample in detecting Covid 19.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/09/028083 | 27 January 2021 | Effect of poor sleep hygiene and screen time usage on sleep | Impact of stress and screen time on sleep among Medical students in COVID era | | Sri Ramachandra Institute of Higher Education and Research Institute SRIHER DU | 28-09-2020 | 20200928 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47599 | Not Recruiting | No | | | | 01-10-2020 | 330 | Observational | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | VSudha Kumari→ | | 2D,Department of Physiology
Sri Ramachandra Medical College & Research Institute , SRIHER (DU)
No: 1 Ramachandra Nagar
Porur
Chennai 600 116 → | priscillajohnson@sriramachandra.edu.in→ | 9884348585→ | Sri Ramachandra Medical College & Research Institute , SRIHER (DU)→ | Inclusion criteria: Medical students between 18 and 25 years of age will be included in the study→ | Exclusion criteria: H/O epilepsy, psychiatric disorder,cerebrovascular accidents or those with any hormonal derailments like hypothyroidism <br/ ><br>Subjects who are on psychoactive medications or any other medications that may affect the neurocognitive and behavioural functions like acetylcholinesterase inhibitors→ | | | Sleep qualityTimepoint: 16 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/09/028131 | 27 January 2021 | A study of Cordyceps Capsules as an Add-On Therapy in patients with moderate COVID 19 Infection | A Randomized, Double Blind, Placebo Controlled Study to
Evaluate the Efficacy and Safety of Cordyceps Capsules (Food Supplement) as an Add-On Therapy in Patients with Moderate COVID 19 Infection. | | Ambrosia Food Farm Co | 29-09-2020 | 20200929 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46887 | Recruiting | No | | | | 02-10-2020 | 60 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Open Label | N/A | India→ | Dr Sagar Sinha→ | | Department of Emergency Medicine
MGM Medical College and Hospital Sector 1 Kamothe Navi Mumbai → | drsagarsinha@gmail.com→ | 9372277267→ | MGM Medical College and Hospital Navi Mumbai→ | Inclusion criteria: 1. Moderate Category COVID-19 patients as defined by the clinical management protocol issued by WHO and Government of India <br/ ><br>2. Male or female patients â?¥18 years of age. <br/ ><br>3. Patients with co-morbidities (stable diabetes or/and hypertension with medications). <br/ ><br>4. Voluntary willingness to give written informed consent prior to participation in trial. <br/ ><br>5. Male patients who is willing to follow contraceptive measures . <br/ ><br>6. Female should be of non-childbearing potential, either surgically sterile or postmenopausal. <br/ ><br>7. Female of childbearing potential should agree to use effective contraceptive measures <br/ ><br>8. Willingness and ability to comply with trial and follow-up procedures. <br/ ><br>→ | Exclusion criteria: 1. Patients who refuse to give consent for participation. <br/ ><br>2. Mild and severe COVID-19 infection <br/ ><br>3. Patient with asymptomatic infection. <br/ ><br>4. Patients who are allergic to Cordyceps Capsules. <br/ ><br>5. Patients already enrolled in another intervention trial. <br/ ><br>6. Patients who receive immunomodulant therapy like Tocilizumab or convalescent plasma or high-dose pulse steroid therapy. <br/ ><br>7. Autoimmune diseases such as multiple sclerosis (MS), systemic lupus erythematosus (SLE) rheumatoid arthritis (RA) other conditions. <br/ ><br>8. Patients with any bleeding disorder e.g. hemophilia and von Willebrand disease. <br/ ><br>9. Patients in whom the surgeries are planned during the study. <br/ ><br>10. Pregnant or breastfeeding. <br/ ><br>11. Concurrent condition that in the investigatorâ??s opinion would jeopardize compliance with the protocol. <br/ ><br>12. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J00-J99- Diseases of the respiratory system
→ | Intervention1: Cordyceps capsules 500 mg plus standard treatment: Cordyceps 500 mg capsule will be administered three times a day after food as an add-on to the standard therapy. Treatment will be given for 15 days<br>Control Intervention1: Placebo Plus Standard treatment: Placebo capsule will be administered three times a day after food as an add-on to the standard therapy. Treatment will be given for 15 days <br>Standard treatment protocol as per recent Clinical Management Protocol for Covid-19, given by Government of India.<br>→ | Number of patients showing improvement in clinical symptomsTimepoint: Within 30 days→ | | | | Yes | False | | |
| → | CTRI/2020/09/028122 | 27 January 2021 | Homoeopathy in the prevention of COVID-19 | Homoeopathic medicines in the prevention of COVID-19 among high risk individuals: A community based, double-blind randomized controlled trial | | Ministry of AYUSH Govt of India | 29-09-2020 | 20200929 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47851 | Not Recruiting | No | | | | 06-10-2020 | 15992 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3 | India→ | Shubhamoy Ghosh→ | | Department of Pathology &Microbiology, Ground floor, Mahesh Bhattacharyya Homoeopathic Medical College and Hospital,
Dr. Bholanath Chakraborty Sarani, Doomurjala, Howrah-711104, West Bengal, India → | shubhamoy67@gmail.com→ | 9831034229→ | Mahesh Bhattacharyya Homoeopathic Medical College and Hospital→ | Inclusion criteria: a)Persons residing in the ward no. 27 under Howrah Municipal Corporation. <br/ ><br>d)Person giving consent to participate (guardianâ??s consent in cases of minors) <br/ ><br>→ | Exclusion criteria: a)Diagnosed cases of COVID-19 or persons with related symptoms <br/ ><br>b)People who have already taken homoeopathic medicines in some forms within the last 15 days <br/ ><br>c)Cases with vital organ failure <br/ ><br>d)Immune compromised state <br/ ><br>→ | | Intervention1: Arsenicum album 30: Two doses of medicated globules (no. 10) will be given as single dose once in a week for two weeks. The cane sugar globules will be medicated with the medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach.; Route of administration: Oral; Duration of therapy: 2 weeks<br>Intervention2: Oscillococcinum® (Anas barbariae hepatis et cordis extractum 200K): Two doses of medicated globules (no. 10) will be given as single dose once in a week for two weeks. The medicine will be obtained as provided by the concerned manufacturer. Each dose to be taken orally on clean tongue with empty stomach.; Route of administration: Oral; Duration of therapy: 2 weeks<br>Intervention3: Influenzinum 30: Two doses of medicated globules (no. 10) will be given as single dose once in a week for two weeks. The cane sugar globules will be medicated with the medicine (preserved in 90% v/v ethanol) to be taken orally on clean tongue with empty stomach.; Route of administration: Oral; Duration of therapy: 2 weeks<br>Control Intervention1: Placebo: This arm, will receive placebo, indistinguishable from verum. Each dose shall consist of 4 globules (no.10) for children aged up to 12 years and 8 globules (no. 10) for person aged 13 years or above. The globules will be moistened with 90% v/v ethanol to be taken orally on clean tongue with empty stomach, once daily for subsequent 6 days. Duration of intervention will be 6 days, followed by follow up period of 24 days.<br>Control Intervention2: Placebo: This arm, will receive placebo, indistinguishable from verum. Dose and Frequency: Each dose shall consist of globules no. 10, moistened with 90% v/v ethanol. Each dose to be taken orally on clean tongue in empty stomach, once in a week for consecuti→ | Occurrence of newly diagnosed (laboratory confirmed) COVID-19 infection rates across the groupsTimepoint: After 30 days of first medicine intake or once the person reports the tests positive for the same.→ | | | | Yes | False | | |
| → | CTRI/2020/09/028132 | 27 January 2021 | A cross sectional study to assess the impact of COVID-19 on patints with non communicable disease at AYUSH LSD clinics | Impact and management of Covid-19 Pandemic on patients with Non-communicable disease: A cross sectional study at AYUSH LSD Clinics of Krishna and Darjeeling District | | Central Council for Research in Homoeopathy | 29-09-2020 | 20200929 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47860 | Not Recruiting | No | | | | 05-10-2020 | 450 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Praveen Oberai→ | | 61-65, Institutional area
opp D Block Janakpuri
New Delhi
Clinical Research
Room no. 406 → | drdnayak@gmail.com→ | 9873404012→ | Central Council for Research in Homoeopathy→ | Inclusion criteria: 1Patients under treatment for non communicable diseases at AYUSH LSD clinic at Krishna and Darjeeling district <br/ ><br>2Patient who give their verbal consent→ | Exclusion criteria: Patients who do not give verbal consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To estimate the impact of covid19 on patients suffering from non communicable diseasesTimepoint: one time→ | | | | Yes | False | | |
| → | CTRI/2020/09/028133 | 27 January 2021 | Oral VIRAHALT (Novel Immunomodulatory Herbal combination) Compared to standard of care in Subjects with Moderate to Severe COVID-19 | An Open-label, Prospective, Randomized, Clinical Trial to Compare the Efficacy and Safety of VIRAHALT® Plus Standard of Care with Standard of Care Alone for the Treatment of Moderate to Severe COVID-19 Infection - VIRA 1 | | LK Wellness | 29-09-2020 | 20200929 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47866 | Recruiting | No | | | | 05-10-2020 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Padmanaban KG→ | | LK Wellness
#75 3rd Cross Residency Road
Next to Ballal Residency, Bengaluru,
→ | pady72@rediffmail.com→ | 9008445984→ | LK Wellness→ | Inclusion criteria: 1. Patients with laboratory-confirmed (PCR) COVID-19 infection <br/ ><br>2. Patients with moderate to severe COVID-19 infection (Early warning score â?¥5) <br/ ><br>3. Hospitalized patients in clinical centres <br/ ><br>4. Patients with radiology-confirmed pneumonia within the clinical condition of COVID-19 infection including pulmonary opacity <br/ ><br>5. Patients with a clinical indication for pneumonia: increased body temperature (defined as a value above â?¥ 36.6â?°C axillary route, â?¥ 37.2°C oral route or â?¥ 37.8 °C rectal route), dyspnoea, cough and SpO2 <96% <br/ ><br>6. Patients aged â?¥18 years, both genders <br/ ><br>7. Patients or LAR able and willing to understand the study, adhere to all study procedures and sign a written Informed Consent Form (ICF) prior to entering the study or with the assistance of the witness <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Patients not COVID-19 PCR positive <br/ ><br>2. Patients with mild COVID-19 infection <br/ ><br>3. Patients who are study subjects in another clinical study for another investigational agent for COVID-19 <br/ ><br>4. Patients with malignant disease and who are treated for malignant diseases in the last 5 years <br/ ><br>5. Patients with severe liver and kidney insufficiency (Hepatic enzymes (AST, ALT, ALP): 6. More than three times normal at baseline will be excluded. Bilirubin: More than 2 at baseline will be excluded. GFR: Less than 60 at baseline will be excluded) <br/ ><br>7. Patients who are receiving therapy with another experimental immunomodulatory or immunosuppressive agent <br/ ><br>8. Patients aged < 18; female patients who are pregnant or breastfeeding <br/ ><br>9. Known allergy to study nutraceutical or any component thereof <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: VIRAHALT plus Standard of Care (SOC): Oral VIRAHALT (Immunomodulatory Herbal combination) plus SOC (Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Government of India, Version 4 Dated 27-06-2020)<br><br>Route of administration of VIRAHALT: Oral. <br>VIRAHALT Dose: One capsule TID. <br>Duration of VIRAHALT therapy: 21 days as per protocol. <br><br>In addition to VIRAHALT, Standard of care (SOC) will be provided as per the current COVID-19 guidelines mentioned above. <br>Standard of care to be continued as decided by the principal investigator. <br><br><br>Intervention2: Standard of Care: Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Government of India, Version 4 Dated 27-06-2020<br>Control Intervention1: Standard of Care (SOC): Standard of care (SOC) will be provided as per the current COVID-19 guidelines (Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Government of India, Version 4 Dated 27-06-2020).<br><br>Duration: Standard of care to be continued as decided by the principal investigator. <br><br><br>→ | Primary: <br/ ><br>Time to onset of change in the patients clinical condition <br/ ><br>Safety and tolerability evaluation <br/ ><br> <br/ ><br>Secondary: <br/ ><br>Length of in-hospital stay <br/ ><br>Survival rate <br/ ><br>All-Cause Mortality <br/ ><br>Intubation rate <br/ ><br>Proinflammatory markers levels <br/ ><br> <br/ ><br>Timepoint: Enrolment <br/ ><br>Day 3 <br/ ><br>Day 7 <br/ ><br>Day 14 <br/ ><br>Day 21→ | | | | Yes | False | | |
| → | CTRI/2020/09/028153 | 27 January 2021 | A survey is to study the prophylactic effect of Homoeopathic medicine namely Arsenicum album 30 against COVID 19 infection in Madurai tamilnadu | A Research Study Proposal On
A Survey On The Effectiveness Of Arsenicum Album As A Prophylactic Medicine For Covid 19 Among The Residents Of Tirumangalam, Madurai.
- SAAM | | National institute of Homoeopathy | 30-09-2020 | 20200930 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47878 | Not Recruiting | No | | | | 05-10-2020 | 10000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr karthikeyan→ | | Groung floor Government Homoeopathic medical college Thirumangalam Madurai → | drtajnih@gmail.com→ | 9007431779→ | National Institute of Homoeopathy→ | Inclusion criteria: 1. Those residents of Tirumangalam, Madurai who received Arsenicum Album 30c as a Prophylactic measure irrespective of age, sex, occupation, comorbidities etc <br/ ><br>2. Those who have not taken Arsenicum Album 30c as a Prophylactic measure <br/ ><br>→ | Exclusion criteria: 1. Those who have been tested positive for Covid 19 before taking Arsenicum Album 30c→ | | Intervention1: Not applicable: Not applicable<br>Control Intervention1: Not applicable: Not applicable<br>→ | To assess the efficacy of Arsenicum Album as a Prophylactic medicine against COVID 19Timepoint: 1 month→ | | | | Yes | False | | |
| → | CTRI/2020/09/028158 | 27 January 2021 | Ayurvedic Proprietary Medicine (VIRANORM) clinical trial on COVID-19 patients | A clinical study to evaluate the role of Herbal Immunomodulator (VIRANORM) as an add on treatment in Asymptomatic and mildly symptomatic covid-19 confirmed cases. - VIRA 2 | | LK Wellness | 30-09-2020 | 20200930 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47896 | Recruiting | No | | | | 05-10-2020 | 250 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | N/A | India→ | Dr Padmanaban KG→ | | LK Wellness #75 3rd Cross Residency Road Next to Ballal Residency, Bengaluru,
→ | pady72@rediffmail.com→ | 9008445984→ | LK Wellness→ | Inclusion criteria: 1. Must be â?¥18 years and â?¤70 years at the time of signing the informed consent <br/ ><br>2. Understand and voluntarily sign an informed consent document prior to any study-related assessments/procedures <br/ ><br>3. Able to adhere to the study visit schedule and other protocol requirements <br/ ><br>4. Asymptomatic or Mild Symptomatic PCR positive COVID-19 infection with outpatient/in-patient management as decided by the treating physician <br/ ><br>5. Early warning score for 2019-nCoV infected patients < 5 <br/ ><br>6. Females of childbearing potential must agree to utilize two reliable forms of contraception simultaneously or practice complete abstinence from heterosexual contact for at least 28 days before starting study drug while participating in the study (including dose interruptions), and for at least 28 days after study treatment discontinuation and must agree to regular pregnancy testing during this timeframe <br/ ><br>7. Members of the same household may participate in the study as long as the inclusion and exclusion criteria are met <br/ ><br>→ | Exclusion criteria: 1. Requirement for oxygen administration <br/ ><br>2. Shortness of breath in resting position <br/ ><br>3. Creatinine > 2.0 mg/dl <br/ ><br>4. Concomitant bacterial respiratory infection documented by respiratory culture. NOTE: Subjects on empirical antibiotic treatment for possible but unproven bacterial pneumonia, but who are positive for SARS-CoV-2, are allowed in the study (will be randomized to the same treatment to maintain blinding). <br/ ><br>5. Women during pregnancy and lactation <br/ ><br>6. Participation in other clinical trials or observation period of competing trials <br/ ><br>7. Use of adrenocorticosteroids (except topical or inhaled preparations or oral preparations equivalent to or less than 10 mg of oral prednisone) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ ><br>8. Serious chronic disease (e.g., human immunodeficiency virus [HIV], cancer requiring chemotherapy within the preceding 6 months, and/or moderate or severe hepatic insufficiency). <br/ ><br>9. Physician decision that involvement in the study is not in the patient´s best interest <br/ ><br>10. History of alcohol or drug abuse in the previous two years. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: VIRANORM plus Standard of Care (SOC): Oral VIRANORM (Ayurvedic Proprietary Medicine) plus SOC (Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Government of India, Version 4 Dated 27-06-2020) <br>Route of administration - Oral. <br>VIRANORM Dose - 1 Capsule every 6 hours.<br>Duration of VIRANORM treatment: 21 days. <br><br>The Standard of care (SOC) will be provided as per the current COVID-19 guidelines (Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Government of India, Version 4 Dated 27-06-2020). Duration: Standard of care to be continued as decided by the principal investigator.<br>Control Intervention1: Placebo plus Standard of Care (SOC): Placebo plus SOC (Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Government of India, Version 4 Dated 27-06-2020)<br>Duration of Placebo: 21 days. <br> <br>The Standard of care (SOC) will be provided as per the current COVID-19 guidelines (Clinical Management Protocol: COVID-19 Ministry of Health and Family Welfare. Government of India, Version 4 Dated 27-06-2020). <br>Duration: Standard of care to be continued as decided by the principal investigator.<br>→ | Difference in disease manifestation in asymptomatic patients <br/ ><br>Difference in time to resolution of clinical signs and symptoms of mild COVID-19 <br/ ><br>Proportion of patients with negative COVID-19 PCR test at day 21 in per protocol population <br/ ><br>Difference between VIRANORM - and placebo treated patients on an ordinal outcome scale until Day 21 (death, admission to intensive care, hospitalization, duration of hospitalization, continuing disease, recovered) <br/ ><br>Timepoint: Enrolment <br/ ><br>Day 3 <br/ ><br>Day 7 <br/ ><br>Day 14 <br/ ><br>Day 21 <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/09/028162 | 27 January 2021 | A prospective cohort study of the effects of COVID-19
in pregnancy and the neonatal period | A prospective cohort study of the effects of COVID-19
in pregnancy and the neonatal period - INTERCOVID | | Not Funded | 30-09-2020 | 20200930 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46374 | Not Recruiting | No | | | | 01-10-2020 | 1500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Argentina;Brazil;Egypt;France;Ghana;India;Indonesia;Italy;Japan;Macedonia;Mexico;Nigeria;Pakistan;Russian Federation;Spain;United Kingdom;United States of America→ | Dr Manjushri Waikar→ | | Department of Obstetrics and Gynecology, Government Medical College, Nagpur HANUMAN NAGAR→ | manjuw123@gmail.com→ | 9823099031→ | Department of Obstetrics and Gynecology, Government Medical College, Nagpurt→ | Inclusion criteria: â??Exposedâ?? cases are defined as pregnant women with either: a) laboratory confirmed COVID-19; b) radiological pulmonary findings suggestive of COVID-19; c) maternal symptoms compatible with COVID-19 according to a predefined list, or d) absence of symptoms, whilst in close interaction with a person(s) with confirmed COVID-19 (a proxy for asymptomatic cases, one of the main problems in controlling the pandemic). <br/ ><br>â??Exposedâ?? cases will be compared with two â??non-exposedâ?? pregnant women per case <br/ ><br>considered as representative of the pregnant population at each study site. The selection of <br/ ><br>the â??non-exposedâ?? women is a central point of the study to reduce selection bias. <br/ ><br>→ | Exclusion criteria: Non- Pregnant women→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NA: Two Pregnant/ Delievered women without COVID Infection consecutively following one COVID Positive Pregnant/ Delievered women.<br>→ | 1] maternal pregnancy-related morbidities 2] an unweighted â??maternal morbidity indexâ??. 3]neonatal outcomes: a) the â??severe neonatal morbidity indexâ?? <br/ ><br>b)the â??neonatal morbidity and mortality indexTimepoint: 7,14,21,28 days whilst the mother and /or child remain in the hospital. <br/ ><br>Stay in Neonatal Intensive Care Unit (NICU) for â?¥7 days, or severe neonatal complications.→ | | | | Yes | False | | |
| → | CTRI/2020/09/028157 | 27 January 2021 | Perspective of MBBS Students towards Teaching through Onscreen Classes | Evaluation of Knowledge, Attitude and Perception of MBBS Students towards Teaching through Onscreen Classes during Covid - 19 Pandemic | | PIMS | 30-09-2020 | 20200930 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47423 | Not Recruiting | No | | | | 10-10-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Nipunjot Grewal→ | | Department of Pharmacology, Room no. 3095 Punjab Institute of Medical Sciences, Jalandhar Pharmacology Punjab Institute of Medical Sciences
Jalandhar→ | baljitjassal@gmail.com→ | 9463887086→ | Punjab Institute of Medical Sciences→ | Inclusion criteria: Students of 1, 2, 3 MBBS Professional will be enrolled.→ | Exclusion criteria: Those who do not want to participate Voluntarily→ | | | To find the Knowledge and attitude of MBBS students towards teaching through onscreen classesTimepoint: 1 month→ | | | | Yes | False | | |
| → | CTRI/2020/09/028156 | 27 January 2021 | Comparative Study of Artificial Intelligence and Radiologists in Assessing Severity of COVID19 Patient Images | Clinical Validation of LungIQ for Severity Scoring for COVID19 using Chest Computed Tomography Imaging | | Predible Health Private Limited | 30-09-2020 | 20200930 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47790 | Not Recruiting | No | | | | 04-10-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Investigator Blinded | N/A | India→ | Dr Amit Kumar Sahu→ | | Department of Radiology,
Max Super Speciality Hospital, Saket,
1, Press Enclave Road, Saket New Delhi → | drsahuamit@gmail.com→ | | Max Healthcare→ | Inclusion criteria: 1. Confirmed diagnosis of COVID-19, confirmed by RT-PCR <br/ ><br>2. Non-contrast CT scan with slice thickness < 5mm <br/ ><br>3. Both lungs must be fully visible within the field of view→ | Exclusion criteria: 1. Individuals with CT scans that have motion artefacts and/or poor image quality <br/ ><br>2. Apices cannot be cropped→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: LungIQ: Artificial Intelligence Based Software Tool for COVID19 Severity Scoring from CT imaging<br>Control Intervention1: Manual Radiologists Report: Standard of care routine radiology reports without any software aid<br>→ | On 25 point Severity Score, Within 1 class accuracy of LungIQ with Radiologists Assessment more than 80%Timepoint: End of Study→ | | | | Yes | False | | |
| → | CTRI/2020/09/028165 | 27 January 2021 | A cross sectional study to identify the symptoms that are presenting by COVID-19 suffering people in Bangladesh | Symptoms presentation among the COVID-19 survivors in Bangladesh | | Mohammad Anwar Hossain | 30-09-2020 | 20200930 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47824 | | No | | | | 05-10-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Bangladesh→ | KM Amran Hossain→ | | Bangladesh Health Professions Institute (BHPI), CRP, Savar, Dhaka-1343 MPT program, Department of Physiotherapy, BHPI, CRP, Savar, Dhaka→ | anwar_physiobd@yahoo.com→ | 01753559949→ | Centre for the Rehabilitation of the Paralysed (CRP)→ | Inclusion criteria: 1.Patients who will be diagnosed COVID-19 positive by RT-PCR test. <br/ ><br>2.The age range will be above 18 years because usually affected COVID-19 in elderly age and younger age people will affect but not more susceptible <br/ ><br>3.Male and female will be same prioritized although more male is more at risk→ | Exclusion criteria: 1.Patients who will be the severe physical illness that they are unable to communicate with others. <br/ ><br>2. Patients who are below 18 years old <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | The primary outcome of this study will be the pain types and severity, muscle strength, cardio-respiratory functioning among the COVID-19 survivors in BangladeshTimepoint: Primary outcomes of this will be calculated after 3 months of data collection.→ | | | | Yes | False | | |
| → | CTRI/2020/09/028164 | 27 January 2021 | A clinical trail to know the efficacy of Homoeopathic medicine as an adjuvant therapy to Standard treatment in COVID-19 patients | A Proposal On
An Evaluation On Effectiveness Of Homoeopathic Intervention As An Add On Therapy In The Management Of Covid 19 Infection â?? An Open Label Prospective Single Arm Observational Clinical Trial
| | National institute of Homoeopathy | 30-09-2020 | 20200930 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47843 | Not Recruiting | No | | | | 04-10-2021 | 50 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Nithiyaselvi→ | | Room no 24 OPD Block ESI Hospital Ayanavaram chennai 23 → | drrajanih@gmail.com→ | | National Institute of Homoeopathy→ | Inclusion criteria: 1. Hospitalized patients with confirmed COVID-19 with a clinical categorization of mild and moderate <br/ ><br>2. Age between 18 years to 80 years of both gender <br/ ><br>→ | Exclusion criteria: 1. Patients with severe or critical COVID-19 infection. <br/ ><br>2. Persons with severe primary respiratory disease or other pneumonia <br/ ><br>3. Pregnant women <br/ ><br>4. Persons with severe medical conditions requiring intensive managements <br/ ><br>5. COVID-19 positive cases participating as subjects in the interventional arm of other COVID-19 clinical trials <br/ ><br>6. Patients who have received organ transplantation in the past 6 months or planning surgery. <br/ ><br>7. Patients with complications of Diabetes, Severe Heart, Liver, kidney, brain, blood disease. <br/ ><br>8. Patients with any active malignancy. <br/ ><br>9. Septicemia/Multi organ failure syndrome. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: B25-B34- Other viral diseases
→ | Intervention1: indicated Homoeopathic Medicine: Four Globules thrice daily in oral route until recovery of the patient<br>Control Intervention1: Not applicable: Not applicable<br>→ | Symptomatic Betterment,Sign betterment,NLR Ratio & X-Ray finding before and after treatment <br/ ><br>Timepoint: one month→ | | | | Yes | False | | |
| → | CTRI/2020/10/028195 | 27 January 2021 | The role of Yogic breathing techniques in progression and recovery from COVID-19. | The role of Yogic breathing techniques among quarantined HCWs, COVID-19 positive and COVID 19 convalescent patients: A randomized clinical trial
| | Ministry of AYUSH Government of India | 01-10-2020 | 20201001 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47893 | Recruiting | No | | | | 08-10-2020 | 72 | Interventional | Randomized, Crossover Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable | N/A | India→ | Dr Akshay Anand→ | | Room No. 3036, Research block B, Neuroscience Research Lab, Department of Neurology, Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh → | akshay2anand@gmail.com→ | 09815968102→ | PGIMER Chandigarh→ | Inclusion criteria: The Quarantined COVID-19 suspects, COVID-19 convalescent and COVID-19 positive patients will be enrolled in the study based on their quarantined venue, recovery or the admission to the hospital, as the case may be, after the initial screening as per the Institutes guidelines. Patients between the age group of 15 â?? 70 years will be considered for this study.→ | Exclusion criteria: Pediatric cases upto the age of 14 year will not be recruited in this study. Subjects will not be recruited if they are yoga practitioners. <br/ ><br>COVID-19 patients on a ventilator and those with epilepsy, brain tumor, brain aneurysm, and pregnancy or those not cleared by medical opinion for the breathing techniques. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Yogic breathing: Yoga:SHORT DURATION BREATHING TECHNIQUE(SDBT)<br><br>Time Interval : 3-5 minutes<br>Preparation: eyes closed, sit with cross legs<br>Process: Powerful inhalation/ exhalation (Bhastrika pranayama) 21 times with constrictions from the throat and no abdominal jerks. It is followed by sitting relaxed with fullness of breath for 30 sec - 1 min (Mouth closed, Eyes closed)<br><br><br>Yoga: LONGER DURATION BREATHING TECHNIQUE(LDBT)<br>Time interval: 12-18 minutes<br>Preparation: Crossed leg posture with straight spine, hands-on thighs with palms facing upwards, face slightly upwards, mild focus between the eyebrows<br>Process has 3 Stages (Yogic Breathing with A kaara chanting)<br>Stage 1: Inhale / Exhale while inhaling mentally saying, I am not the body and while exhaling mentally saying, I am not even the mind.,<br>Stage 2: Utter â??aaâ?? 7 times, producing the sound from the navel region with mouth wide open. <br>Not very loud but enough to feel the vibrations produced by the sound<br>Stage 3: Sit silent for 5-6 minutes with face slightly upwards with mild focus between the eyebrows.<br><br><br>Control Intervention1: Yogic breathing: SDBT: 15 day intervention on COVID-positive<br>Control Intervention2: No intervention: COVID-positive with usual care.<br>Control Intervention3: Yogic breathing : SDBT and LDBT: 15 day intervention on COVID recovered and health care worker.<br>Control Intervention4: No intervention: COVID recovered and health care worker with no intervention will act as control.<br>→ | Anxiety, stress, post traumatic stress, triguna, tridosha, Mental wellbeing, wellness and resilience <br/ ><br>Timepoint: baseline, after 15 days→ | | | | Yes | False | | |
| → | CTRI/2020/10/028196 | 27 January 2021 | Coping with COVID Pandemic | Coping with COVID-19 Pandemic: a Population Based Study in Bangladesh | | K M Amran Hossain | 01-10-2020 | 20201001 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47979 | | No | | | | 10-10-2020 | 3000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Bangladesh→ | Asma Islam→ | | Department of Physiotherapy, Bangladesh Health Professions Institute, Savar, Dhaka → | amranphysio@gmail.com→ | 8801735661492→ | Bangladesh Health Professions Institute→ | Inclusion criteria: Any person in living in Bangladesh who are coping with COVID-19 Pandemic→ | Exclusion criteria: The person who can not respond to the questions and who are not willing to participate→ | | Intervention1: N/A: N/A<br>Control Intervention1: N/A: N/A<br>→ | Coping with COVID-19 Pandemic by BRIEF COPETimepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/10/028202 | 27 January 2021 | Clinical profile of neonates with suspected or proven SARS-CoV-2 infection | Clinical profile of neonates born to mothers with SARS-CoV-2 infection | | Dr Deepak Chawla | 01-10-2020 | 20201001 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47798 | Not Recruiting | No | | | | 12-10-2020 | 30 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Deepak Chawla→ | | Department of Neonatology
Block D, Level 4, Government Medical College Hospital → | drdeepak@gmch.gov.in→ | 9646121559→ | Government Medical College Hospital→ | Inclusion criteria: Following neonates will be enrolled in the study <br/ ><br>1. Neonates born in the hospital with COVID-19 infection in pregnant mother within 2 weeks before birth <br/ ><br>2. Neonates presenting to the hospital with history of postnatal exposure to infected mother, other family member or healthcare <br/ ><br>provider. <br/ ><br>3. Neonates presenting with severe acute respiratory illness after 48-72 h of birth with illness which cannot be explained by other <br/ ><br>causes or perinatal events (irrespective of history of exposure) and test positive for COVID-19 infection→ | Exclusion criteria: There are no exclusion criteria apart from refusal of parents to participate in the study (prospective arm).→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Incidence of vertical transmission (positive RT-PCR in first sample)Timepoint: At birth and at 5-14 days of life→ | | | | Yes | False | | |
| → | CTRI/2020/10/028192 | 27 January 2021 | A survey to assess the effectiveness of Arsenicum Album 30C as a Prophylactic medicine against COVID 19 infection | A Research Study Proposal On
A Survey On The Effectiveness Of Arsenicum Album 30 As A Prophylactic Medicine For Covid 19 Among The Residents Of Dharawi, Mumbai.
- NIL | | National institute of Homoeopathy | 01-10-2020 | 20201001 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47846 | Not Recruiting | No | | | | 04-10-2020 | 15000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Selvan→ | | 306 vallabh CHS 90 Feet road
Dharavi Mumbai Maharastra → | drrajanih@gmail.com→ | 9163955737→ | National Institute of Homoeopathy→ | Inclusion criteria: 1. Those residents of Dharawi who received Arsenicum Album 30c as a Prophylactic measure irrespective of age, sex, occupation, comorbidities etc <br/ ><br>2. Those who have not taken Arsenicum Album 30c as a Prophylactic measure <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Those who have been tested positive for Covid 19 before taking Arsenicum Album 30c <br/ ><br> <br/ ><br>→ | | Intervention1: Not applicable: Not applicable<br>Control Intervention1: Not applicable: Not applicable<br>→ | Prophylaxic action of Arsenicum album 30 against COVID 19Timepoint: minimum 1 month→ | | | | Yes | False | | |
| → | CTRI/2020/10/028179 | 27 January 2021 | An experimental study to find out the impact of post COVID physiotherapy and rehabilitation in Bangladesh | Impact of Post COVID Physiotherapy and Rehabilitation in Bangladesh | | Mohammad Anwar Hossain | 01-10-2020 | 20201001 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47847 | | No | | | | 07-10-2020 | 300 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Outcome Assessor Blinded | N/A | Bangladesh→ | KM Amran Hossain→ | | Bangladesh Health Professions Institute (BHPI), CRP, Savar, Dhaka-1343 MPT program, Department of Physiotherapy→ | anwar_physiobd@yahoo.com→ | 01753559949→ | Centre for the Rehabilitation of the Paralysed (CRP)→ | Inclusion criteria: 1.Patients who will be diagnosed COVID-19 positive by RT-PCR test. <br/ ><br>2.The age range will be above 18 years because usually affected COVID-19 in elderly age and younger age people will affect but not more susceptible. <br/ ><br>3.Male and female will be same prioritized although more male is more at risk <br/ ><br>4.People who are willing to participate. <br/ ><br>→ | Exclusion criteria: 1.Patients who will be the severe physical illness that they are unable to communicate with others. <br/ ><br>2.Patients who are below 18 years old. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Physiotherapy & rehabilitation intervention protocol: Experimental group-Ice packs, hot packs, general mobilization, Isometric exercises, Strengthening exercise, active assisted, resisted exercise, Positioning, Interval training exercise, aerobic exercises, active cycle breathing techniques, Buteyko breathing techniques, respiratory strengthening training exercise, and relaxation techniques <br>Control group- General stretching exercise.<br>Educational booklet group- An educational booklet<br>Control Intervention1: Physiotherapy intervention, educational booklet: experimental group- a set of physiotherapy interventions once in week for 6 weeks. <br>Educational booklet group: An educational booklet containing home exercise protocol, patient education.<br>→ | The primary outcome of this study will be the pain types and severity, muscle strength, cardio-respiratory functioning between the (3) three groups. Pain types and severity will be measured by the Mcgill pain questionnaire and modified Orebro musculoskeletal index. Muscle strength of the upper limb and lower limb will be measured by hand dynamometer and modified hand dynamometer. The cardio-respiratory function will be measured by six minutes walk test, spirometry.Timepoint: baseline data pain types, severity, functional status, cardiorespiratory functional status will be collected at first. then after 4 session, post intervention data will be collected. It will take 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/10/028230 | 27 January 2021 | clinical trial of Pippali Rasayana and Nagaradi Kashaya Ghana Vati combination as an adjuvant treatment with ICMR guided medicines in Covid-19 positive mildly symptomatic cases | Randomized comparative clinical trial to assess the efficacy of Pippali Rasayana and Nagaradi Kashaya Ghana Vati combination as an adjuvant treatment with ICMR directed therapy in Covid-19 positive mildly symptomatic cases | | Government of India AYUSH EMR scheme | 05-10-2020 | 20201005 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47188 | Not Recruiting | No | | | | 12-10-2020 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | DrYogita Abhijit Jamdade→ | | PDEAs Ayurved Rugnalaya and Sterling Multispecialty Hospital Sector no 27 Kayachikitsa OPD No 117 Nigdi Pradhikaran Pune
PDEAs Ayurved Rugnalaya and Sterling Multispecialty Hospital Sector no 27 Kayachikitsa OPD No 117 Nigdi Pradhikaran Pune
→ | medhamaheshjoshi@gmail.com→ | 9881465798→ | PDEAs Ayurved Rugnalaya and Sterling Multispeciality Hospital Nigdi Pradhikaran Pune 44→ | Inclusion criteria: 1 Patients with Covid -19 test positive (Confirmed using RT-PCR test) <br/ ><br>2 Covid-19 positive patients willing to participate in the study. <br/ ><br>3 Patients of either sex having age above 20 yrs. below 70 yrs. <br/ ><br>4 Covid-19 positive mildly symptomatic <br/ ><br>→ | Exclusion criteria: 1. Covid-19 positive patients having moderate to severe symptoms <br/ ><br>2. Requiring immediate Intensive care. <br/ ><br>3. Patients having complications of major illness such as Liver/Kidney failure <br/ ><br> Encephalopathy, Epileptic attacks, Coagulopathies, Neuromuscular diseases, Cancer <br/ ><br>4. Uncontrolled DM(HbA1C > 7.5) and its complications <br/ ><br>5. Uncontrolled HTN and complications <br/ ><br>6. Tuberculosis, Pleural Effusion, collapse of any lobe of Lung Ca Lung, COPD patients with dyspnea SPO2 <90, Respiratory rate > 20, requiring Nebulization frequently <br/ ><br>7. Immunocompromised patients <br/ ><br>8. Anemic patients having Hb <7 g/dl <br/ ><br>9. BMI > 40 <br/ ><br>10. Pregnant and Lactating ladies <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Pippali Rasayana<br>Nagradi Kashaya Ghana Vati<br><br>and ICMR directed therapy <br>: Pippali Rasayana- 2gm O.D. orally Rasayana Kala With Honey- 3gm<br>Ghee- 5gm for 14 days<br>Nagaradi Kashaya Ghana Vati- 500mg B.D orally Vyanodana Kala for 14 days<br><br><br>Control Intervention1: ICMR directed treatment for Covid19 mildly symptomatic cases along with Pippali Rasayan and Nagaradi Kashay Ghana Vati: ICMR Directed therapy for covid 19 mildly symptomatic patients<br>along with Pippali Rasayana and Nagaradi Kashay Ghana Vati in one group and only ICMR directed therapy in another group<br>→ | Covid-19 positive mildly symptomatic patients will turn Covid negative after administration of combination of Pippali Rasayana +Nagaradi Kashaya Ghana Vati along with the ICMR guided treatment <br/ ><br>Recovery from the symptoms will be early and significant after administration of Pippali Rasayana +Nagaradi Kashaya Ghana Vati in mildly symptomatic Covid 19 positive patients <br/ ><br> <br/ ><br>Timepoint: Day 0 Day 14 <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/10/028233 | 27 January 2021 | Study on use of Homoeopathy Medicines in Treatment of Covid 19 cases | Homoeopathy Medicines as add-on Therapy in the Management of Covid-19 cases at Covid care centre in kanniyakumari District- A Clinical Trial
| | Ministry of Ayush | 05-10-2020 | 20201005 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47982 | Not Recruiting | No | | | | 10-10-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr SUGATHAN N V→ | | Dr.N.V.Sugathan
Principal & Professor
Department of Practice of medicine
Room No: 407
sarada krishna Homoeopathic medical college
Kulasekharam
Kanniyakumari District
Tamilnadu - 629161 → | college@skhmc.org→ | 9443558786→ | sarada krishna homoepathic medical college→ | Inclusion criteria: Covid positive cases who are willing to participate <br/ ><br>with asymptomatic and mild symptom presentation→ | Exclusion criteria: patients who are unwilling to participate <br/ ><br>Moderate to severe disease presentation <br/ ><br>immuno compromised <br/ ><br>uncontrolled chronic diseases <br/ ><br>malignancy→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Homoeopathy medicines Arsenicum Album, Bryonia alba, Rhus Toxicodendron, Belladonna Gelsemium and Eupatorium Perfoliatum: Based on individualization<br>Initial prescription starting with 30th potency 4 globules of 40 size 4th hourly for the treatment period i.e. till negativity.<br>Dose and potency may be modified as per the second prescription guidelines as demanded by the case<br>Control Intervention1: standard treatment along with Homoeopathy: Treatment strategy adopted in the covid care centre, along with selected Homoeopathy medicines based on individualization. <br>Initial prescription <br>Starting with 30th potency 4 globules of 40 size 4th hourly for the treatment period i.e. till negativity.<br>Dose and potency may be modified as per the second prescription guidelines as demanded by the case<br>→ | 1)Incidence of Patients progression from No/Mild symptoms to Moderate/Severe Symptoms <br/ ><br>2) Duration from Positive to Negative <br/ ><br>Timepoint: 1)from baseline until the duration of disease course <br/ ><br>2) whole positivity period <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/10/028231 | 27 January 2021 | Proof of Concept Study of Ketoji (Liquid) for its Effectiveness in Treatment and Management of COVID-19 Patients | An Investigator Initiated, Open Label, Multi Center, Proof of Concept Study of Ketoji (Liquid) for its Effectiveness in Treatment and Management of COVID-19 Patients | | Dr Kapil G Zirpe | 05-10-2020 | 20201005 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47237 | Not Recruiting | No | | | | 12-10-2020 | 15 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Ms Pranjal Ausekar→ | | Office No.304 Level-3
Gagan Kaptial Building Opposite to Kapila Hotel
Dhole Patil Road→ | kapilzirpe@gmail.com→ | 9822844212→ | Ruby Hall Clinic (Grant Medical Foundation, Pune)→ | Inclusion criteria: a. Patients of either sex, 18 to 75 years of age (both inclusive). <br/ ><br>b. Patients with diagnosis of coronavirus (SARS-CoV-2) infection conformed by polymerase chain reaction (PCR) test and sign of mild acute respiratory infection or with respiratory stress. <br/ ><br>c. Patients with body muscle pain/fatigue. <br/ ><br>d. Able to abide the dietary regime mentioned by the investigator. <br/ ><br>e. Willing to come for regular follow â??up visits. <br/ ><br>f. Able to give written informed consent.→ | Exclusion criteria: a. Known history of hypersensitivity to dietary supplements. <br/ ><br>b. Volunteers receiving any COVID-19 specific antiviral treatment. <br/ ><br>c. Concurrent respiratory diseases such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days) prior to COVID-19 diagnosis. <br/ ><br>d. Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I. <br/ ><br>e. Volunteers having systemic diseases like diabetes mellitus (Type I or Type II) and other debilitating metabolic diseases. <br/ ><br>f. Pregnant or lactating women <br/ ><br>g. Female subjects of childbearing potential not willing to use contraceptive methods <br/ ><br>h. Male subjects not willing to use contraceptive methods <br/ ><br>i. On-going treatment with herbals or any other immune boosting dietary supplements. <br/ ><br>j. History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing. <br/ ><br>k. Patients with ARDS of Cardiac origin <br/ ><br>l. Any condition that in the opinion of the investigator does not justify the patientâ??s inclusion for the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: KETOJI: Ketoji is liquid containing 25 gm of Beta-hydroxybuterate (BHB) i.e. 41.6% BHB esters and 57.39% solvent (Water) with no added salts or acids.<br>Control Intervention1: NA: NA<br>→ | Change from the baseline in <br/ ><br>1 Body Temperature and Pulmonary Function Tests (FVC, FEV1) by Spirometer. <br/ ><br>2 pO2, pCO2 (blood gas analysis) showing improvement P/ F ratio as 300 <br/ ><br>3 Subjectâ??s feedback on muscle fatigue and overall well-being, atleast 5 days from last visit (post COVID-19). <br/ ><br>4 Chest X Ray or CT shows improved pulmonary edema or bilateral, patchy alveolar opacities/ consolidations â??â??white lungâ??â?? appearance.Timepoint: From Baseline Day 0 to Day 5→ | | 01/12/2020 | | Yes | False | | |
| → | CTRI/2020/10/028234 | 27 January 2021 | Study to compare the effect of different antiviral medicines in COVID-19 infected sick children | Efficacy of antiviral agents in moderate to severe COVID-19 in pediatrics â?? a pilot RCT | | Dept of Pediatrics Medical College Kolkata | 05-10-2020 | 20201005 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47844 | Not Recruiting | No | | | | 12-10-2020 | 45 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 4 | India→ | Dr Sumantra Kumar Raut→ | | Dept of Pediatrics, SNM 1st floor, Medical College,
88, College Street, Kolkata, West Bengal → | drsuman.raut@gmail.com→ | 8240852469→ | Medical College, Kolkata→ | Inclusion criteria: 1) High initial clinical suspicion by physician as SARI based on signs and symptoms (fever, cough, myalgias, fatigue, shortness of breath) followed by positive RT-PCR/ True NAAT/ Antigen test in Nasopharyngeal/ oropharyngeal swab for confirmation of COVID-19 diagnosis <br/ ><br>OR <br/ ><br>Referred from other center as COVID-19 + by RT-PCR/ True NAAT/ Antigen in NPS/OPS <br/ ><br> <br/ ><br>2) Moderate to severe COVID-19 symptoms <br/ ><br>3) Willing to give informed written consent→ | Exclusion criteria: i. Unable to take enteral drug (orally or by NG tube) <br/ ><br>ii. Known hypersensitivity to HCQs or other 4-aminoquinoline compounds, or doxycycline <br/ ><br>iii. Already taking HCQs or chloroquine within 1 month due to any reason <br/ ><br>iv. Known G6-PD deficiency <br/ ><br>v. History of retinopathy <br/ ><br>vi. History of congenital cardiac diseases <br/ ><br>vii. QTc > 440 mS at admission, abnormal cardiac rhythm at screening <br/ ><br>viii. Suspected or proven scrub typhus <br/ ><br>ix. Suspected or proven malaria <br/ ><br>x. Patient terminally moribund and unlikely to survive beyond 24 hrs as per physicianâ??s discretion <br/ ><br>xi. Participation in any other clinical trial of an experimental agent treatment for COVID-19 <br/ ><br>xii. Concurrent treatment with other agents with direct acting antiviral activity against COVID-19 <br/ ><br>xiii. Requiring mechanical ventilation at screening <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: hydroxychloroquine (HCQ): HCQ 8 mg/kg/dose loading followed by 4 mg/kg/dose BD for 5 days per oral or NG tube along with standard conservative treatment (syr zinc 20 mg OD and multivitamine syr with vitamin A 2500 IU/ml OD)for 10 days per oral/NG tube<br>Control Intervention1: Intravenous Doxycycline: 4.5 mg/kg/day in 2 divided doses IV for 7 days along with standard conservative treatment (syr zinc 20 mg OD and multivitamine syr with vitamin A 2500 IU/ml OD)for 10 days per oral/NG tube<br>Control Intervention2: standard conservative treatment (syr zinc 20 mg and multivitamine syr with vitamin A 2500 IU/ml): syr zinc 20 mg OD and multivitamine syr with vitamin A 2500 IU/ml OD)for 10 days per oral/NG tube<br>→ | To determine the efficacy of HCQs vs doxycycline vs standard conservative treatment in respect to improvement of clinical status from day 1 to day 10 of hospitalization/ final outcome day as assessed by improvement in the 8-point ordinal scale score (defined below) ranging from death (category 1) to discharged (category 8) in patients 1-12 years of age with moderate to severe COVID-19 infectionTimepoint: from day 1 to day 10→ | | | | Yes | False | | |
| → | CTRI/2020/10/028232 | 27 January 2021 | Psychological effect of coronavirus disease 2019 on pregnant women | Psychological impact of coronavirus disease 2019 on pregnant women presenting to our dedicated COVID hospital: A cross sectional study | | AIIMS Patna | 05-10-2020 | 20201005 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48105 | Not Recruiting | No | | | | 14-10-2020 | 25 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Poonam Kumari→ | | Department of anaesthesia ,B block ,5th floor ,OT complex ,faculty lounge, AIIMS Patna → | drpoonam1981@gmail.com→ | 9473199126→ | AIIMS Patna→ | Inclusion criteria: consenting uncomplicated antenatal women in any the first to third trimester of pregnancy, with single fetus, confirmed by obstetrical examination and ultrasonography.→ | Exclusion criteria: multiple pregnancies, complications of pregnancy (severe medical-surgical or psychiatric illness), physical handicap, and who suffered a major stressful life event in 6 months before conceiving (e.g., death of spouse or a close family member, marital separation or divorce,Pregnant patients with psychiatric illness, inability to comprehend→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | determine the stress or anxiety faced by COVID positive pregnant patients in due to their diseaseTimepoint: 4 month→ | | | | Yes | False | | |
| → | CTRI/2020/10/028254 | 27 January 2021 | â??Retrospective Study of Pregnancy with COVID-19â?? | â??Retrospective Analysis of COVID-19 patients in Obstetrics - PregCOVID | | Shashikala Bhat | 06-10-2020 | 20201006 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47156 | Not Recruiting | No | | | | 08-10-2020 | 44 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shashikala Bhat→ | | Department of OBG, Dr. TMA Pai Hospital, Udupi, MMMC, MAHE Department of OBG, Dr. TMA pai Hospital, Udupi, MMMC, MAHE→ | shashidixith@gmail.com→ | 9611362119→ | Manipal Academy of Higher Education→ | Inclusion criteria: Pregnancy with COVID-19→ | Exclusion criteria: Non pregnant <br/ ><br>No COVID-19→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B998- Other infectious disease
→ | Control Intervention1: NIL: NIL<br>→ | Pregnancy outcome in COVID-19Timepoint: Pregnancy outcome in COVID-19 at 2weeks→ | | | | Yes | False | | |
| → | CTRI/2020/10/028253 | 27 January 2021 | A clinical trial to test the effectiveness of thalidomide in reducing immune dysfunction in covid-19 disease. | Use of thalidomide as a universally affordable immunomodulator in patients with moderate and moderate-to-severe COVID-19 disease | | Dr Abhijit R Lodha | 06-10-2020 | 20201006 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47986 | Not Recruiting | No | | | | 10-10-2020 | 20 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Abhijit R Lodha→ | | Department of General Medicine
Ruby Hall Clinic
Sassoon Road
Pune
→ | drabhijitlodha@gmail.com→ | 9503289647→ | Ruby Hall Clinic→ | Inclusion criteria: i. Adult patients between the ages of 18-65 diagnosed with swab-positive covid-19 pneumonia (with moderate and moderate to severe disease) <br/ ><br> <br/ ><br>ii. Radiographic evidence of pulmonary involvement <br/ ><br> <br/ ><br>iii. Requiring any external respiratory assistance (either supplementary oxygen or bipap) <br/ ><br> <br/ ><br>iv. PaO2/FiO2 ratio <300 but >100 <br/ ><br> <br/ ><br>v. Already on standard therapy including dexamethasone and remdesivir in standard doses as prescribed by ICMR <br/ ><br> <br/ ><br>vi. Patients with raised inflammatory mediators (including interleukin-6) who are considered candidates for routinely used immunomodulators such as tocilizumab but unable to afford it <br/ ><br>→ | Exclusion criteria: i. Pregnant women <br/ ><br> <br/ ><br>ii. Women of child-bearing age where pregnancy cannot be unequivocally excluded <br/ ><br> <br/ ><br>iii. Patients who have received colony stimulating factors, blood transfusions, or have other systemic conditions that could confound the measured inflammatory markers. <br/ ><br> <br/ ><br>iv. Patients with hepatic dysfunction <br/ ><br> <br/ ><br>v. Patients requiring invasive ventilatory support, irrespective of their PaO2/FiO2 ratio <br/ ><br> <br/ ><br>vi. Pre-existing uncontrolled comorbidities including, but not limited to, COPD, asthma, interstitial lung disease, pulmonary hypertension, cardiac failure, hepatorenal failure. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Thalidomide: Drug - Thalidomide<br>Dose - 100 mg, single tablet <br>Frequency - Once daily<br>Route of administration - Oral<br>Duration of therapy - 7 days<br>Control Intervention1: N/A: N/A<br>→ | Reduction in Interleukin-6 levelsTimepoint: Day 7→ | | 02/12/2020 | | Yes | False | | |
| → | CTRI/2020/10/028257 | 27 January 2021 | Psychological Impacts Of The COVID-19 Pandemic On Medical Students In India: A Web-Based Cross-Sectional Study | The Psychological Impact Of The COVID-19 Pandemic On Medical Students In India: A Web-Based Cross-Sectional Study | | NIL | 06-10-2020 | 20201006 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48025 | Not Recruiting | No | | | | 10-10-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr S Natarajan→ | | Department Of Psychiatry,
Room Number-11
Sri Ramachandra Institute Of Higher Education And Research
Porur Chennai 600116 → | natarajans@sriramachandra.edu.in→ | 9843730810→ | Sri Ramachandra Institute Of Higher Education And Research→ | Inclusion criteria: 1.Participants aged 18 years and above. <br/ ><br>2.Participants will be recruited from regions <br/ ><br> afflicted by the COVID-19 pandemic. <br/ ><br>3.Participants willing to participate in the <br/ ><br> study. <br/ ><br>4.Participants with the ability to read, write and understand English language. <br/ ><br>→ | Exclusion criteria: 1.Participants who are less than 18 years <br/ ><br> of age <br/ ><br>2.Participants who suffer from a known primary <br/ ><br> psychiatric disorder. <br/ ><br>3.Participants from regions not affected by with the COVID-19 pandemic. <br/ ><br>4.Participants who are unwilling to participate <br/ ><br> in the study. <br/ ><br>→ | | | Life Orientation Test- Revised and K-10 Scales and Questionnaire ScoresTimepoint: Baseline values→ | | | | Yes | False | | |
| → | CTRI/2020/10/028256 | 27 January 2021 | A study to know whether we can supervise cancer patients infected with COVID-19 from without admission in hospitals. We will test how much helpful is a software called Datos health along with pulse oximeter and thermometer in this supervision by doctors. | To test the feasibility of a novel machine-learned triage software, Datos in
conjunction with pulse oximeter and temperature device for remote screening, monitoring, and triage of oncology patients infected with COVID-19. | | Tata Memorial Hospital Research Administrative Council | 06-10-2020 | 20201006 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48118 | Not Recruiting | No | | | | 13-10-2020 | 30 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Manju Sengar→ | | Room No. 81,
Ground Floor
Adult Hematolymphoid Unit
Main Building
Dr. E. Borges Road
Parel, Mumbai → | manju.sengar@gmail.com→ | 02224177211→ | Tata Memorial Centre→ | Inclusion criteria: 1. Male or Female adults age greater than or equal to 18 years old. <br/ ><br>2. All Patients must have an oncologic diagnosis. <br/ ><br>3. Patients must be positive for COVID-19 and require outpatient monitoring. <br/ ><br>4. ECOG greater than or equal to 2. <br/ ><br>5. Able to sign informed consent and to comply with protocol. <br/ ><br>6. Patients must be comfortable with using the pulse oximeter and thermometer device as well as be able to follow basic instructions for the device in the opinion of the study team.→ | Exclusion criteria: 1. Clinical illness requiring hospitalization. <br/ ><br>2. Unable to consent, use and follow the study device instructions for the entire study period. <br/ ><br>3. Substance and/or alcohol abuse <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Datos Platform in conjunction with thermometer and pulse oximeter.: Datos platform is a phone application available in public domain. The platform will be utilized to integrate readings from pulse oximeter and thermometer device and will help clinicians to keep a constant eye on things from far.<br>Control Intervention1: None.: It is a single arm feasibility study. There will be no comparator agent.<br>→ | a) Proportion of patients recording data in a continuous manner using Datos Platform <br/ ><br>b) Patient experience using a validated Usefulness, Satisfaction, and Ease of use (USE) Questionnaire to assess compliance and user/patient experience.Timepoint: a) After 24 hour or at the end of completion of study (between 1 to 4 week).→ | | | | Yes | False | | |
| → | CTRI/2020/10/028250 | 27 January 2021 | A study to evaluate the effects of stem cells in patients with Acute Respiratory Distress syndrome caused by Pneumonia due to COVID-19 | A Randomized, Controlled, Open Label, Multicentre, Two Arm, Two Dosage, Phase II Study
Assessing the Efficacy and Safety of Intravenous Administration of Adult Human Bone Marrow
Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells in Patients with Acute
Respiratory Distress Syndrome Caused by Pneumonia due to COVID-19 | | ICMR | 06-10-2020 | 20201006 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48119 | Not Recruiting | No | | | | 14-10-2020 | 40 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2 | India→ | Dr Geeta Jotwani→ | | Indian Council of Medical Research Department of Health Research
Ministry of Health & Family Welfare(Govt. of India) Ansari Nagar,
New Delhi → | pawan.gupta@stempeutics.com→ | 8025028101→ | Stempeutics Research pvt. Ltd.→ | Inclusion criteria: Patients must satisfy all of the following criteria to be included in the <br/ ><br>study: <br/ ><br>1. Males or females of age 18 to 65 years of Indian origin and diagnosed with COVID-19 by reverse transcription polymerase chain <br/ ><br>reaction (RT-PCR) assay. <br/ ><br>2. Informed consent by the patient or his/her legal representative in case the patient is not capable of giving the consent. <br/ ><br>3. Patients diagnosed with COVID-19 pneumonia causing moderate and severe ARDS as per the Berlin ARDS definition. <br/ ><br>a. Respiratory failure within one week of a known insult or new and/or worsening respiratory symptoms <br/ ><br>b. Respiratory failure not fully explained by cardiac function or volume overload <br/ ><br>c. Moderate to severe hypoxemia must be present, defined as the <br/ ><br>ratio of PaO2/FiO2 on at least PEEP 5cmH2O: <br/ ><br>i Moderate ARDS: PaO2/FiO2 >100 mmHg and ?200 mmHg, on <br/ ><br>ventilator settings that include PEEP ?5 cm H2O OR <br/ ><br>ii Severe ARDS: PaO2/FiO2 ?100 mmHg on ventilator settings that include PEEP ?5 cm H2O <br/ ><br>d. Bilateral opacities in chest X-ray or CT scan. <br/ ><br>4. Patients requiring mechanical ventilatory support. <br/ ><br>5. Patients who can start receiving BMMSCs within 72 hours (3 days) after the diagnosis of ARDS.→ | Exclusion criteria: Patients may not be selected if any of the following criteria are <br/ ><br>present <br/ ><br>1. Any other cause of ARDS not attributable to SARS-CoV2. <br/ ><br>2. Patients whose life expectancy is < 6 months because of other causes other than the respiratory failure. <br/ ><br>3. Presence of any active <br/ ><br>malignancy. <br/ ><br>4. Any end stage organ disease as assessed by investigator which may possibly affects the safety of the study drug. <br/ ><br>5. Patient with history of any stem cell transplant in the past. <br/ ><br>6. Moderate to severe liver failure (Child â?? Pughâ??s score > 12). <br/ ><br>7. Patient with chronic respiratory disease or use of home oxygen therapy or use of ventilator at home. <br/ ><br>8. Patients for whom one week or longer has passed since the attachment of ventilator. <br/ ><br>9. Patient with pulmonary transplant or having history of lung lobectomy. <br/ ><br>10. Patient with clinically findings consistent with diffuse alveolar haemorrhage. <br/ ><br>11. Patients with mean arterial (blood)pressure 12. Patients who are appropriate to be treated with extracorporeal membrane oxygenation <br/ ><br>(ECMO) at screening or currently receiving ECMO. <br/ ><br>13. Patients who were resuscitated after cardio-respiratory arrest. <br/ ><br>14. Patients with uncontrolled co-morbidities like hypertension,diabetes mellitus etc., as per investigator discretion <br/ ><br>15. Patients who are under artificial dialysis at screening. <br/ ><br>16. Patient documented to have deep venous thrombosis or pulmonary embolism within last 3 months. <br/ ><br>17. Patients with a history of myocardial infarction within 6 months before screening. <br/ ><br>18. Women of childbearing age who are not using an adequate method of contraception. If the patient is menopausal, it must be documented. <br/ ><br>19. Pregnancy or breast feeding. <br/ ><br>20. Patient with HIV infection. <br/ ><br>21. Patient expected to have hypersensitivity for the study drug and/or excipients.→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Stempeucel®: Ex - vivo cultured allogeneic<br>Mesenchymal stromal cells at a<br>dose of 200 million cells at Day 0 and Day 3<br>Control Intervention1: Control Arm: Standard of Care<br>→ | The primary efficacy endpoints are: <br/ ><br>i. Mechanical ventilator free days 28 days after <br/ ><br>administration of BMMSCs <br/ ><br>ii. Percent mortality 28 days after administration <br/ ><br>of BMMSCsTimepoint: The primary efficacy endpoints are: <br/ ><br>i. Mechanical ventilator free days 28 days after <br/ ><br>administration of BMMSCs <br/ ><br>ii. Percent mortality 28 days after administration <br/ ><br>of BMMSCs→ | | | | Yes | False | | |
| → | CTRI/2020/10/028251 | 27 January 2021 | COVID-19 and Children with congenital heart disease | Impact of COVID-19 on the Care of Children with Heart Disease: A Multicentric study under Pediatric Cardiac Society of India | | Pediatric Cardiac Society of India | 06-10-2020 | 20201006 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47097 | Not Recruiting | No | | | | 15-10-2020 | 50 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr S Ramakrishnan→ | | Dept of Cardiology,
Seventh Floor,
C N Centre,
AIIMS, Ansari Nagar → | ramaaiims@gmail.com→ | 9818186179→ | AIIMS, New Delhi→ | Inclusion criteria: a) All Paediatric patients ( <18 years of age) with heart disease <br/ ><br>b) All grown-up adults with congenital heart disease (operated or unoperated) <br/ ><br>c) Admitted to the participating hospitals in the study period <br/ ><br>d) And tested positive for COVID-19 with any of the available tests in the preceding 28 days <br/ ><br>→ | Exclusion criteria: Complete medical records not retrievable→ | Health Condition 1: Q20- Congenital malformations of cardiac chambers and connections
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. To study the outcome of children hospitalized with heart disease and COVID-19 infection between 01 April 2020 and 31 Aug 2020Timepoint: Outcome data will be collected retrospectively, till the time of death/recovery/discharge from hospital→ | | | | Yes | False | | |
| → | CTRI/2020/10/028280 | 27 January 2021 | A Study to Evaluate Efficacy of Selected Homoeopathic Medicines in Prevention of COVID-19 | A Pragmatic, Placebo-controlled, Parallel Groups, Randomised Clinical Trial to Assess the Efficacy of Homoeopathic Medicine(s) in the Prevention of COVID-19 in a High Risk / Exposed Population | | Directorate of AYUSH Govt of NCT of Delhi | 07-10-2020 | 20201007 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48199 | Not Recruiting | No | | | | 15-10-2020 | 18000 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Meeta Gupta→ | | Directorate of AYUSH (Homoeopathic Wing), CSC-III, First Floor, B-Block, Preet Vihar, Delhi → | drmeetagupta@gmail.com→ | 9811727072→ | Directorate of AYUSH (Homoeopathic Wing), Govt. of NCT of Delhi→ | Inclusion criteria: Asymptomatic sybjects (no symptoms of fever, cough, breathlessness in the previous 7 days). <br/ ><br>Living in a containment zones and family/community/social clusters of positive cases. <br/ ><br>Subjects of 18 to 60 years of age. <br/ ><br>→ | Exclusion criteria: Has taken any of the medication Arsenic album 30, Camphora 1M, Bryonia alba 30 during last one month. <br/ ><br>Tested positive for COVID-19 with RT-PCR/Ag Test. <br/ ><br>Any member of household tested positive for COVID-19 with RT-PCR/Ag Test. <br/ ><br>Individuals with uncontrolled, unstable comorbidities. <br/ ><br>Malignant, HIV and Immunocompromised patients. <br/ ><br>Patients taking Corticosteroids or on chemotherapy. <br/ ><br>Pregnant Women and Lactating Mothers. <br/ ><br>Patients with Septicemia, UTI or any other infection.→ | | Intervention1: Homoeopathic Medicine: Subjects will receive either of the three medicines (Arsenic album 30, Camphora 1M, Bryonia alba 30) or placebo. Two doses each of 4 pills of size 30 to be administered daily for 7 days; thereafter two doses once a day every week for the entire study period.<br>Control Intervention1: Placebo: Subjects will receive either of the three medicines (Arsenic album 30, Camphora 1M, Bryonia alba 30) or placebo<br>→ | Proportion of individuals in each of the groupsâ?? that develop COVID-19, confirmed with the RT-PCR/Ag test. <br/ ><br>Average duration in which individuals turned positive/developed symptoms.Timepoint: Baseline; thereafter every seventh day→ | | | | Yes | False | | |
| → | CTRI/2020/10/028277 | 27 January 2021 | A study to assess the safety and effectiveness of Thymosin α-1 (Tα1) used for the treatment of Moderate to severe COVID 19 Patients.
| A Double Blind, Multi-Center, Two- Arm, Randomized, Placebo Controlled, Phase III Clinical Study to Evaluate the Effectiveness and Safety of Thymosin α-1 (Tα1) as an Add on Treatment to Existing Standard of Care Treatment
in Moderate to Severe COVID-19 Patients
| | Gufic Biosciences | 07-10-2020 | 20201007 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47691 | Not Recruiting | No | | | | 12-10-2020 | 120 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 3 | India→ | Mr Vairamuthu Ammaiyappan→ | | 4th Floor Ektha Serene located at 103 H G B and 104 HIG B Survey No 132 APHB Colony Gachibowli → | medicalaffairs@guficbio.com→ | 912267261000→ | Gufic Biosciences Limited→ | Inclusion criteria: 1. Male or female of more than or equal to 18 years of age at the time of consent <br/ ><br>2. Patient who can and willing to provide written Informed Consent <br/ ><br>3. Patient or patientâ??s LAR understands and is willing to participate in the clinical study and can comply with clinical trial protocol requirements <br/ ><br> <br/ ><br>Inclusion criteria for moderate COVID-19 patients <br/ ><br> <br/ ><br>4. Moderate Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or any other confirmatory tests <br/ ><br>5. Patient with pneumonia with no signs of severe disease <br/ ><br>6. If the patient presents any one of the following features: <br/ ><br>- Respiratory rate of more than or equal to â??24 breath per min <br/ ><br>- SpO2 (oxygen saturation) more than 90 percent to less than or equal to 94 percentage on room air <br/ ><br> <br/ ><br>Inclusion criteria for severe COVID-19 patients <br/ ><br> <br/ ><br>7. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase chain reaction (PCR) test or any other confirmatory tests <br/ ><br>8. If the patient presents any one of the following features: <br/ ><br>- respiratory distress with a respiratory rate of more than or equal toâ??30 breath per min <br/ ><br>- SpO2 (oxygen saturation) less than or equal toâ??90 percentage on room air <br/ ><br>- PaO2 (arterial blood oxygen partial pressure) or FiO2 (Fraction of Inspired Oxygen) less than or equal toâ??200 mmHg (1 mmHgâ??equal toâ??0.133 kPa) <br/ ><br>- Patient presents respiratory failure and requires mechanical ventilation support <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Patient who has participated in any other clinical trial of an experimental treatment for COVID-19 <br/ ><br>2. Patients with the presence of any pre-existing illness that, in the opinion of the investigator, would place the patient at an unreasonably increased risk through participation in this study. <br/ ><br>3. Patient who has participated in another trial with an investigational drug within 1 month prior to this trial. <br/ ><br>4. Female patient who is breast-feeding, pregnant, or intends to become pregnant during the study <br/ ><br>5. Patients who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Thymosin α-1-1.6 mg Injection <br> along with SOC: Each vial contains : Thymosin Alpha 1-1.6mg<br>Excipients...... q.s (Lyophilized)<br>Sterile water for Injections IP 1ml Ampoule<br>Manufactured by: Gufic Biosciences Ltd., India<br>Dose:Thymosin α-1-1.6 mg x 2 injections<br>Frequency: Twice daily(Moderate)and Thrice daily (Severe)<br>Route of administration: Subcutaneous <br>Total Duration 7 days<br><br><br>Control Intervention1: Placebo Injection along with SOC: Each vial contains : Excipients...... q.s (Lyophilized)<br>Sterile water for Injections IP 1Ml Ampoule<br>Manufactured by: Gufic Biosciences Ltd., India<br>Dose: Placebo x 2 injections<br>Frequency: Twice daily(Moderate)and Thrice daily (Severe)<br>Route of administration: Subcutaneous <br>Total Duration 7 days<br><br><br>→ | 1. Incidences of all-cause hospital mortality [Time Frame: From the date of Drug administered until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 28 days] <br/ ><br>2.Evaluation of Clinical progression/deterioration based on an 8-point ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID-2019) R&D) [time frame up to 7 days] on Day 1, Screening and End of treatment (Day 7) <br/ ><br>Timepoint: 1.Day 1 to Day 28 <br/ ><br>2.Day 1 to Day 7 <br/ ><br>3.From baseline to hospital <br/ ><br>discharge→ | | | | Yes | False | | |
| → | CTRI/2020/10/028278 | 27 January 2021 | The Knowledge, Attitude And Practices related to COVID-19 in Patients Presenting to Glaucoma Clinic and the Reasons for seeking Glaucoma care | The KNowledge, Attitude and Practices related to COVID-19 pandemic in patients presenting to glaucoma clinic and the reasons for seeking glaucoma care. | | kalluri satya srividya | 07-10-2020 | 20201007 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47232 | Not Recruiting | No | | | | 12-10-2020 | 246 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Kalluri Satya Srividya→ | | Department of Glaucoma, room no 20, 1st floor,Aravind Eye Hospital, Cuddalore Main Road, Thavalakuppam, Pondicherry → | venkatesh@aravind.org→ | 9443094321→ | Aravind Eye Hospital→ | Inclusion criteria: 1. Primary and Secondary Open and Closed Angle Glaucoma, Disc suspects, Ocular hypertension <br/ ><br>2. Age >18years→ | Exclusion criteria: 1.Patients cross referred from other ophthalmic specialties for secondary raised intra-ocular pressure <br/ ><br>2. Patients with positive COVID-19 symptoms→ | Health Condition 1: H40- Glaucoma
→ | | We would know the reasons for seeking care, and to assess knowledge, attitude and practices realted to COVID 19 pandemic.Timepoint: There is no followup of the patients, same day patient will be assessed and after completion of study period i.e 3months approximately results will be calculated.→ | | | | Yes | False | | |
| → | CTRI/2020/10/028279 | 27 January 2021 | Standard of care with homoeopathy as adjuvant in COVID19 | Homeopathy as adjuvant to standard treatment protocol in management of corona virus infection- a randomized, placebo controlled, open label study | | Central Council for Research in Homeopathy Ministry Ministry of Ayush | 07-10-2020 | 20201007 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48085 | Not Recruiting | No | | | | 12-10-2020 | 128 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label | N/A | India→ | Dr Sushma Bhatnagar→ | | Room No. 242, 2nd Floor, Dr. B.R.A. IRCH, All India Institute of Medical Science (AIIMS), Ansari Nagar → | sushmabhatnagar1@gmail.com→ | 01129575209→ | All India Institute of Medical Sciences (AIIMS)→ | Inclusion criteria: 1. Age > 18 years <br/ ><br>2. All sexes <br/ ><br>3. Case definitions for inclusion in the study will include moderate and severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVID19 issued by Ministry of Health and Family Welfare, Govt of India on 07 Apr 2020. <br/ ><br>a. Moderate: Pneumonia with no signs of severe disease (Respiratory Rate 15 to 30/minute, SpO2 90%-94%). <br/ ><br>b. Severe: Severe Pneumonia (with respiratory rate < 30/minute and/or SpO2 and requiring non-invasive ventilatory support <br/ ><br>4. Laboratory confirmed SARS CoV-2 infection within last 10 days or SARS <br/ ><br>5. CoV-2 test result pending with a high clinical suspicion as defined by: <br/ ><br>a. Cough of <10d duration <br/ ><br>b. Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air <br/ ><br>c. No alternative explanation for respiratory symptoms <br/ ><br>d. Scheduled for admission or enrolled within 48h of hospital admission <br/ ><br>→ | Exclusion criteria: 1. Children < 18 years <br/ ><br>2. Covid Positive patients with severe co-morbidities <br/ ><br>3. Pregnant and lactating women, infants and neonates <br/ ><br>4. Not willing to give consent for adjuvant treatment <br/ ><br>5. Inability to be contacted on D14 for clinical outcome assessment (unless died in hospital) <br/ ><br>6. In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ ><br>7. Symptoms of acute respiratory tract infection for > 10d before randomisation, and covid status unknown <br/ ><br>8. Death within 24 Hrs. of admission→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Homoeopathic medicines: A detailed history and examination will be gathered from the already available information of the patient in the admission records at hospital. The patients randomised into experimental group will be interrogated by the homoeopathic physician only for the additional information required from Homoeopathy perspective. <br>As per each case, individualized homoeopathic medicine will be prescribed. A COVID-app and guidelines of Ministry of AYUSH on Homoeopathic treatment of COVID-19 will be consulted for most appropriate prescription. A detailed therapeutic compendium of the medicines most likely to be indicated, as per the symptomatology of moderate and severe covid cases, has been developed by the Homoeopathy team, and will be referred to, after repertorisation of each case in the latest RADAR software ®. <br>Daily recording of the administered dose will be recorded and also captured in the Case Record Form (CRF) developed by the Homoeopathy team, which will be having content other than, and in addition to the standard form, which will be filled at the hospital. If there is any change in dosage / prescription of medications during the study period, that will be mentioned with reason in the prescription chart. If these medicines are stopped, that too would be recorded with reason.<br>Control Intervention1: Globules Pills: Placebo group patients will receive identical placebo (globules moistened with dispensing alcohol) as an add on to standard protocol treatment. Dose repetition will be a in similar pattern to medicine group.<br>→ | To compare duration required for change in disease status (from COVID positive to negative) in patients receiving adjuvant homoeopathic intervention with those receiving conventional treatment as institutional management protocol (IMP) in COVID-19 patients, categorized into moderate to severe stage of the diseaseTimepoint: To compare duration required for change in disease status (from COVID positive to negative) in patients receiving adjuvant homoeopathic intervention with those receiving conventional treatment as institutional management protocol (IMP) in COVID-19 patients, categorized into moderate to severe stage of the disease→ | | | | Yes | False | | |
| → | CTRI/2020/10/028295 | 27 January 2021 | Perception Of Dentists On Infection Control Measures During Novel Corona Virus (COVID-19) Pandemic | Assessment Of Knowledge, Attitude And Practices Among Dental Practitioners On Methods Of Infection Control While Carrying Dental Procedures During Novel Corona Virus (COVID-19) Pandemic | | Dr Neetha Shenoy | 08-10-2020 | 20201008 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48202 | Not Recruiting | No | | | | 25-10-2020 | 400 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Double Blind Double Dummy | N/A | India→ | Dr Neetha Shenoy→ | | Department of Conservative Dentistry and Endodontics,
Manipal College of Dental Sciences,
Manipal Academy of Higher Education, Manipal
Udupi , Karnataka-576104 ,India. → | neetha.gshenoy@manipal.edu→ | 9606728137→ | Manipal College of Dental Sciences, Manipal→ | Inclusion criteria: Dental practitioners practicing in India at all levels of healthcare settings and providing consent to take part in the survey. They must have registered and active members of Dental Council of India.→ | Exclusion criteria: Dental practitioners not currently in practice since last one year; Not providing consent for participation; and students dental practitioners. Practitioners who did not register and or an active members of Dental Council of India.→ | Health Condition 1: K117- Disturbances of salivary secretion
→ | | Assessment of the knowledge, attitude and practices among dental health professionals of India regarding methods of infection control while carrying out the dental procedures during COVID-19 pandemicTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/10/028296 | 27 January 2021 | Impact of the COVID-19 pandemic on graduating dental interns: A studentâ??s perspective | Impact of the COVID-19 pandemic on graduating dental interns: A studentâ??s perspective | | Dr Mathangi Kumar | 08-10-2020 | 20201008 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46970 | Not Recruiting | No | | | | 21-10-2020 | 400 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Mathangi Kumar→ | | Department of Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal, Manipal Academy of Higher Education → | mathangi.kumar@manipal.edu→ | | MCODS,Manipal→ | Inclusion criteria: 1. All students who are willing to participate in the Questionnaire based survey are included in the study. <br/ ><br>2. Students who have passed their IV BDS examinations and are undergoing 1-year compulsory rotatory Internship at various Institutions across India will be included in the study.→ | Exclusion criteria: 1. Students who are not willing to participate in the study <br/ ><br>2.Students who are awaiting results of the examinations <br/ ><br>3. Students who finished internship before the COVID pandemic <br/ ><br>4. Students pursuing dentistry in other countries <br/ ><br>5. Students who are yet to start internship→ | | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | This study will explore and highlight the graduating dental studentsâ?? confidence and preparedness to practice dentistry. It will also reveal the present state of the social and professional well-being of the graduates and how it has impacted their future. The results of the study may help us amend the curriculum to ensure quality dental education even <br/ ><br>in the face of constant disruptions from pandemic outbreaksTimepoint: This study will explore and highlight the graduating dental studentsâ?? confidence and preparedness to practice dentistry. It will also reveal the present state of the social and professional well-being of the graduates and how it has impacted their future. The results of the study may help us amend the curriculum to ensure quality dental education even <br/ ><br>in the face of constant disruptions from pandemic outbreaks→ | | | | Yes | False | | |
| → | CTRI/2020/10/028297 | 27 January 2021 | Cotrimoxazole in hospitalised patients with moderate to early-severe COVID-19 infection | Cotrimoxazole in hospitalised patients with moderate to early-severe COVID-19 infection compared to the standard of care â?? an investigator-initiated, randomised controlled trial (CoTroxCov Study) | | Dept of Health and Family Welfare Government of West Bengal | 08-10-2020 | 20201008 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48268 | Not Recruiting | No | | | | 26-10-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Santanu Kumar Tripathi→ | | Room No 19
Dept of Clinical and Experimental Pharmacology
School of Tropical Medicine
108, C R Avenue Room No 19
Dept of Clinical and Experimental Pharmacology
School of Tropical Medicine
108, C R Avenue→ | tripathi.santanu@gmail.com→ | 9230566771→ | School of Tropical Medicine→ | Inclusion criteria: a. Adult individuals, age >18 and <65 years <br/ ><br>b. COVID-19 infection documented by a positive RT-PCR test <br/ ><br>c. Hospitalised patients with moderate to early-severe COVID-19 infection, characterized by <br/ ><br>fever (at the time of screening or when admitted), oxygen saturation â?¤ 94% on air at rest and requiring supplemental oxygen through mask or nasal cannula/catheter <br/ ><br>d. Clinical/radiological evidence of interstitial pneumonia requiring admission (optional) <br/ ><br>e. Informed verbal consent under urgent conditions, documented in the electronically <br/ ><br>→ | Exclusion criteria: a. Patients who require invasive or non-invasive (including CPAP and high flow nasal cannula) ventilation at the time of inclusion. <br/ ><br>b. AST/ALT values >5 fold the ULN. <br/ ><br>c. Documented impairment of renal function <br/ ><br>d. Absolute neutrophil count below 500 cells/mm3 <br/ ><br>e. Absolute platelet count below 50,000 cells/mm3 <br/ ><br>f. Documented sepsis or high suspicion of superimposed severe bacterial or fungal infection <br/ ><br>g. Comorbidities or concomitant medications likely to be incompatible for cotrimoxazole use <br/ ><br>h. Pregnancy or lactation. <br/ ><br>i. History of cotrimoxazole hypersensitivity <br/ ><br>j. Patients participating in another clinical trial for SARS-CoV-2 infection <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: cotrimoxazole plus standard of care: Patients will receive oral cotrimoxazole 960 mg twice daily for 7 days<br>Control Intervention1: Routine Care: drugs or procedures in routine clinical practice according to the best standard of care as per local protocol.<br>→ | a. Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation compared to baseline <br/ ><br>b. Duration of hospitalisation: Days from the date of enrolment to the date of discharge <br/ ><br>c. Number of in-patient deaths <br/ ><br>Timepoint: Till Discharge→ | | | | Yes | False | | |
| → | CTRI/2020/10/028333 | 27 January 2021 | Prospective on evaluation of use of , â??AyurCoro3â?? as an add on medication for the treatment purpose in COVID-19 patients | Prospective , multi center ,single blind , randomized controlled study on evaluation of use of , â??AyurCoro3â?? as an adjuvant for the treatment purpose in mild to moderate COVID-19 patients at tertiary care center. - AyurCoro3 | | Shri Sarveshwar Seva Sahkari Samstha | 09-10-2020 | 20201009 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48137 | Not Recruiting | No | | | | 13-10-2020 | 500 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Investigator Blinded | Phase 3/ Phase 4 | India→ | Dr Vijaykumar Gawali→ | | Department of Research , 5th Floor, srishti sector 1 ,
Bhaktivedanta Swami Marg , Thane , Mira Road Department of Research , 5th Floor, srishti sector 1 ,
Bhaktivedanta Swami Marg , Thane , Mira Road→ | drvijaykumar@bhaktivedantahospital.com→ | 9320199122→ | Bhaktivedanta Hospital and Research Institute→ | Inclusion criteria: 1. Laboratory confirmed diagnosis of Mild to Moderate COVID-19 patients <br/ ><br>2. Agree to consent for the study. <br/ ><br>3. All Age groups above 18 Years <br/ ><br>4. All genders. <br/ ><br>→ | Exclusion criteria: 1. Patients on ventilator <br/ ><br>2. Critically ill patient <br/ ><br>3. Dyspnea, respiratory frequency â?¥ 30/min, <br/ ><br>4. Blood oxygen saturation (SpO2) â?¤ 90%, <br/ ><br>5. PaO2/FiO2 ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours <br/ ><br>6. Patients with altered mental state <br/ ><br>7. Patients with multiple organ failure requiring ICU monitoring and treatment. <br/ ><br>8. Patients with respiratory failure and requiring mechanical ventilation/ <br/ ><br>9. Patient who have participated in another investigational study within 3 months prior to enrollment in this study <br/ ><br>10. Investigators, study personnel and their first-degree relatives. <br/ ><br>11. Pregnant Patients <br/ ><br>12. Current or future involvement in the active treatment phase of other interventional research studies (excluding observational/non-interventional studies). <br/ ><br>13. Any other clinical reason which may preclude entry in the opinion of the investigator. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: AyurCov3: 10 Ml three times a day for 3 days . One day medication<br>Control Intervention1: Standard of care: As per routine clinical care<br>→ | Time (Days) to clinical improvement from study enrolmentTimepoint: At Baseline, Day three , Day five and Day seven→ | | 29/09/2020 | | Yes | False | | |
| → | CTRI/2020/10/028335 | 27 January 2021 | A clinical study to assess the efficacy and safety of Tinefcon in patients with moderate COVID-19 infection | A multi-centric, open-labeled, prospective, comparative study to evaluate the efficacy and safety of Tinefcon and standard of care versus standard of care alone in patients of moderate COVID-19 - TINEFCON | | Piramal Enterprises Limited | 09-10-2020 | 20201009 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45359 | Not Recruiting | No | | | | 12-10-2020 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | Phase 3 | India→ | Mridul Sharma→ | | Gopikrishna Memorial Hospital, Ganpatrao Kadam Marg, Lower Parel, Mumbai 400013 same→ | rajiv.salvi@piramal.com→ | 9920526213→ | Piramal Enterprises Limited→ | Inclusion criteria: 1. Subjects who are able to provide a written informed consent or have a legally accepted representative to provide the same. <br/ ><br>2. Subjects who are proven to be positive for SARS-CoV-2 infection, as confirmed by the RT-PCR test. <br/ ><br>3. Subjects who are admitted with moderate COVID-19 (MOFHW criteria) for treatment at the hospital having the following clinical criteria: pneumonia with no signs of severe disease; peripheral capillary oxygen saturation (SPO2) between 90 and 94% on room air and respiratory rate between 15 and 30 breaths per minute. <br/ ><br>4. Subjects with arterial partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2) between 200 and 300 mm/Hg. <br/ ><br>5. Female subjects with a negative urine pregnancy test at screening. <br/ ><br>6. Subjects who are able to take the study drug orally and comply with the study procedures→ | Exclusion criteria: 1. Subjects who are participating in any other clinical trial or experimental treatment for COVID-19. <br/ ><br>2. Subjects with persistent vomiting (more than three episodes of vomiting in 12 hours) and who cannot tolerate oral drugs. <br/ ><br>3. Subjects requiring concomitant use of invasive or non-invasive mechanical ventilation. <br/ ><br>4. Subjects requiring vasopressors or ionotropic medications. <br/ ><br>5. Subjects requiring anti-viral drugs like ritonavir, favipirir, lopinavir or monoclonal antibodies like tocilizumab at hospitalization, in the opinion of the Investigator. <br/ ><br>6. Female subjects who are pregnant or lactating. <br/ ><br>7. Subjects who are known to be HIV positive or positive for Hepatitis B or C. (The same may be noted based on history given by the subject or standards of care followed at the individual sites.) <br/ ><br>8. Subjects with history of retinopathy or macular degeneration. <br/ ><br>9. Subjects with prolonged QTc interval at screening ( >450 ms in males and >470 ms in females). <br/ ><br>10. Subjects with liver enzymes (namely alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST)) > 5x upper limit of normal. <br/ ><br>11. Subjects with creatinine clearance <50 ml/min (using Cockgroft-Gault formula). <br/ ><br>12. Subjects who are not deemed fit as per the investigator for any other medical reason→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tinefcon: 2.8g/day (four tablets of 700<br>mg/day) orally once a day for 10 days<br>Control Intervention1: Standard of Care: Tab. Ivermectin 12 mg single dose<br>Tab. Hydroxychloroquine 400 mg twice daily on Day 1, then 400 mg OD for 5 days<br>→ | Clinical response: Resolution of fever <br/ ><br>Clinical Improvement Scale <br/ ><br>Overall survival of the subjects <br/ ><br>Progression of COVID-19 associated pneumonitis <br/ ><br>Cytokine levelsTimepoint: Clinical response: Resolution of fever - measured daily for 10 days <br/ ><br>Clinical Improvement Scale:measured at baseline and days 3, 7 and 10 <br/ ><br>Overall survival of the subjects: at 14 days <br/ ><br>Progression of COVID-19 associated pneumonitis: measured daily for 10 days <br/ ><br>Cytokine levels at baseline and on days 7 and 10→ | | | | Yes | False | | |
| → | CTRI/2020/10/028324 | 27 January 2021 | Evaluation of use of , â??study medication â??for prophylaxis in frontline health care workers involved in treating COVID-19 patients | Prospective , multi center ,open label, pilot study on evaluation of use of , â??AyurCoro-3â?? for prophylaxis purpose in frontline health care workers involved in treating COVID-19 patients. - AyurCoro3 Prophylaxis | | Bhaktivedanta Hospital and Research Institute | 09-10-2020 | 20201009 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47697 | Not Recruiting | No | | | | 09-10-2020 | 120 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Vijaykumar Gawali→ | | Research Dept , 5th Floor ,srishti sector 1
Bhaktivedanta Swami Marg Mira Road ( East ) Thane 401107 Research Dept , 5th Floor ,srishti sector 1
Bhaktivedanta Swami Marg Mira Road ( East ) Thane 401107→ | drvijaykumar@bhaktivedantahospital.com→ | 9320199122→ | Bhaktivedanta Hospital and Research Institute→ | Inclusion criteria: Healthy frontline health care workers ,18 years and above , all genders who are involved in treating COVID-19 patients→ | Exclusion criteria: 1.COVID-19 serology tests positive tests (Institute conducted it recently on all employees) . <br/ ><br> <br/ ><br>2. Experiencing covid 19 symptoms at the time of admission . <br/ ><br> <br/ ><br>3. Already taking some kind of prophylaxis for covid-19 at the time of study enrollment or had taken it within one month of study enrollment . <br/ ><br> <br/ ><br>4. Working less than 3 days a week in the Hospital.→ | | Intervention1: AyurCoro-3: 10 Ml liquid , three times a day for 1 day , to be repeated every 15 days for 3 months<br>Control Intervention1: No Comparator Agent: Not applicable<br>→ | Confirmed cases of a COVID-19Timepoint: At 1 Month→ | | | | Yes | False | | |
| → | CTRI/2020/10/028326 | 27 January 2021 | Assessment of memory cells response to Mycobacterium Indicus Pranii vaccination | Assessment of innate memory NK cells in response to Mycobacterium Indicus Pranii vaccination as a part of a national clinical trial. | | Manashi Chakrabarti Foundation | 09-10-2020 | 20201009 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48214 | Not Recruiting | No | | | | 20-10-2020 | 40 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Open Label | N/A | India→ | Dr Jyoti Rastogi→ | | Dharamshila Narayana Superspeciality Hospital
Vasundhara Enclave, New Delhi-110096, India Dharamshila Narayana Superspeciality Hospital
Vasundhara Enclave, New Delhi-110096, India→ | bmt.dnsh@narayanahealth.org→ | 09811166314→ | Dharamshila Narayana Superspeciality Hospital→ | Inclusion criteria: 1. COVID positive (by RT-PCR method) patients who are critically ill (room air SPO2 < 94%, and RR >25), and health care workers and close contacts. <br/ ><br>2. Signed informed consent→ | Exclusion criteria: 1. Pregnancy <br/ ><br>2. Age-less than 20 years or greater than 80 years <br/ ><br>3. Those with HIV infection, chronic kidney disease, chronic liver disease, hematological malignancy, and those on immunosuppressive drugs <br/ ><br>4. Those who have received hydroxychloroquine for COVID-19→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Mycobacterium Indicus Pranii (MIP) Vaccine<br>: 0.3 ml intradermal on either deltoid for three days in critically ill subjects with COVID-19 disease<br>Intervention2: Mycobacterium Indicus Pranii (MIP) Vaccine: 0.1ml intradermal on both deltoids on day 1, followed by randomization to receive 0.1 ml on day 30, in 30 health care workers or close contacts of COVID-19 patients<br>Control Intervention1: Non-vaccinated health care workers: Till end of study<br>→ | To evaluate the innate memory NK cell in response to MIP vaccine.Timepoint: At day 0 and week 4→ | | | | Yes | False | | |
| → | CTRI/2020/10/028325 | 27 January 2021 | Comparison of Tocilizumab Vs Itolizumab in covid 19 patient. | Comparative study of Tocilizumab Vs Itolizumab in covid 19 Patient â??Randomized control trial | | AIIMS Patna | 09-10-2020 | 20201009 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48319 | Not Recruiting | No | | | | 19-10-2020 | 50 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | Dr Poonam kumari→ | | Department of Anaesthesiology,5th Floor, OT complex, Faculty Lounge, AIIMS Patna. Department of Anaesthesiology,5th Floor, OT complex, Faculty Lounge, AIIMS Patna.→ | drpoonam1981@gmail.com→ | 9473199126→ | AIIMS Patna→ | Inclusion criteria: 1. Age 18 to 60 years <br/ ><br>2. Virological diagnosis of SARS-CoV2 infection <br/ ><br> (PCR) <br/ ><br>3. Patients who are in moderate ARDS following <br/ ><br> COVID-19 infection, as defined by PaO2/FiO2 <br/ ><br> ratio of <200, or more than 25% <br/ ><br> deterioration from the immediate previous <br/ ><br> value within 24hrs in patient having <br/ ><br> po2/fio2 >200. <br/ ><br>4. Baseline serum ferritin level â?¥400ng/mL or <br/ ><br> IL-6 levels greater than 4 times the upper <br/ ><br> limit of normal (ULN) would be included. <br/ ><br>→ | Exclusion criteria: 1. Known case of severe allergic reactions to <br/ ><br> monoclonal antibodies <br/ ><br>2. Active tuberculosis (TB) infection <br/ ><br>3. History of inadequately treated tuberculosis <br/ ><br> or latent tuberculosis <br/ ><br>4. Have received oral anti-rejection or immune- <br/ ><br> suppressive drugs within the past 6 months <br/ ><br>5. Pregnant or breastfeeding, or positive <br/ ><br> pregnancy test in a pre-dose examination <br/ ><br>6. Patients with known history of Hepatitis <br/ ><br> B, Hepatitis C or HIV <br/ ><br>7. Absolute Neutrophils count (ANC) <1000 / mm3 <br/ ><br>8. Platelets <50,000 / mm3 <br/ ><br>9. Absolute Lymphocyte count (ALC): <500/mm3 <br/ ><br>10. Very severe ARDS Pao2/Fio2â?¤100 with PEEPâ?¥5 <br/ ><br>11. ARDS due to others secondary infection/ <br/ ><br> bacterial sepsis (High procalcitonin value) <br/ ><br>12. Those patient who will be recruited for <br/ ><br> another study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Patient will be given itolizumab 1.6mg/kg in a single dose: GROUP2:Patient will be given itolizumab 1.6mg/kg in a single dose<br>Intervention2: Patient will be given Tocilizumab 8mg/kg in a single dose: GROUP 1:Patient will be given Tocilizumab 8mg/kg in a single dose<br>Control Intervention1: Patient will be given Tocilizumab 8mg/kg in a single dose.: Group 1:Patient will be given Tocilizumab 8mg/kg in a single dose.<br>Control Intervention2: Patient will be given itolizumab 1.6mg/kg in a single dose: GROUP 2 :Patient will be given itolizumab 1.6mg/kg in a single dose<br>→ | P/F ratio [ baseline, during treatment before every dose after 12 hr post dose,] daily for one week,14th dayTimepoint: 3 month→ | | | | Yes | False | | |
| → | CTRI/2020/10/028339 | 27 January 2021 | To study the relationship between spirituality,hope, distress and ability to bounce back from stress among family members of recovered COVID-19 patients | Spirituality Hope Resilience and Psychological distress among family members of recovered COVID-19 patients - Nil | | Government Medical College and Hospital Chandigarh | 12-10-2020 | 20201012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47879 | Not Recruiting | No | | | | 01-11-2020 | 30 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ajeet Sidana→ | | Dept. of Psychiatry, level 5, Block-D, Government Medical College and Hospital, Chandigarh Nil→ | mkbajaj@gmail.com→ | 8558890803→ | Government Medical College and Hospital, Chandigarh→ | Inclusion criteria: 1. Above 18 years of age. <br/ ><br>2. Any Gender <br/ ><br>3. Participant should be the 1st degree relative of the patient. <br/ ><br>4. Participant should be currently living with the patient.→ | Exclusion criteria: 1. Participants suffering from major medical (tuberculosis, HIV & AIDS), surgical and neurological disorders (head injury, dementia, delirium or epilepsy) requiring admission or active intervention. <br/ ><br>2. Participants diagnosed and recovered from COVID-19.→ | | Control Intervention1: Nil: Nil<br>→ | There will be a significant correlation between Spirituality, Resilience, Hope and Psychological distress.Timepoint: At baseline→ | | | | Yes | False | | |
| → | CTRI/2020/10/028340 | 27 January 2021 | Clinical characteristics and laboratory parameters of COVID-19 patients on oxygen | Retrospective analysis of clinical characteristics and laboratory parameters of COVID-19 patients on oxygen therapy in tertiary care centre | | NCI Jhajjar | 12-10-2020 | 20201012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46861 | Not Recruiting | No | | | | 20-10-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Anuja Pandit→ | | Department of Onco anaesthesia and Palliative Medicine All India Institute of Medical Sciences New Delhi
→ | anujapandit@yahoo.co.in→ | 9710030457→ | National Cancer Institute, Jhajjar, All India Institute of Medical Sciences→ | Inclusion criteria: 1.Age 18 years or older <br/ ><br>2.Laboratory confirmation of COVID-19 by RT-PCR <br/ ><br>3.Patients on oxygen therapy (nasal prongs, face mask, non-rebreathing mask, high flow nasal cannula, non-invasive ventilation, invasive mechanical ventilation) during their course of admission→ | Exclusion criteria: 1.Missing data on clinical characteristics and laboratory parameters→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To assess the clinical characteristics and laboratory parameters of COVID-19 patients requiring oxygen therapyTimepoint: Time of admission→ | | | | Yes | False | | |
| → | CTRI/2020/10/028364 | 27 January 2021 | A clinical trial to evaluate the effectiveness and safety of Vedicinals-9-a Herbal Formulation in Mild to Moderate COVID-19
Patients. | Randomized, Open Label, Parallel efficacy, Active Control, Multi-Centre Exploratory Trial to
Evaluate Efficacy and Safety of Vedicinals-9, a Herbal Formulation as an Adjunct Treatment to
Standard of Care for the management of Mild to Moderate COVID-19 Patients. | | Vedicinals India Pvt Ltd | 12-10-2020 | 20201012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48152 | Not Recruiting | No | | | | 19-10-2020 | 124 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Open Label | Phase 2 | India→ | Yogendra Kumar Choudhary→ | | Department of Research and Development, Clinical Research Division, CCRP-315, Ambuja City Centre, Vidhan Sabha Road, Mowa
Raipur
→ | yogendrakumar.choudhary@gmail.com→ | 9039340075→ | Ethix Pharma→ | Inclusion criteria: 1. Individuals of either sex above 18 and below 60 years of age <br/ ><br>2. Individuals who have been tested positive to be infected with SARS-COV2 Virus and presenting with no symptoms or mild to moderate symptoms. <br/ ><br>3. Voluntariness to participate in the trial and give signed informed consent. <br/ ><br>→ | Exclusion criteria: 1. COVID-19 Patients with symptoms classified as severe or critical <br/ ><br>2. Individuals with uncontrolled, unstable comorbidities as evaluated by the investigators. <br/ ><br>3. Individuals with preexisting respiratory conditions, severe primary respiratory disease or pneumonia. <br/ ><br>4. Immuno-compromised Individuals or those on immunosuppressant <br/ ><br>5. Patients on or requiring parenteral nutrition/care. <br/ ><br>6. Pregnant/lactating women. <br/ ><br>7. COVID-19 positive individuals participating in the interventional arm of other COVID-19 clinical trial. <br/ ><br>8. Individuals with serious complications of diseases such as cancer, heart disease, infraction, stroke, arterial fibrillation, cardiac arrhythmia, disabilities, neurodegenerative disease. <br/ ><br>9. Subjects with alcohol and/or substance dependence. <br/ ><br>10. Subjects with known allergic reactions to any other herbal supplements. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Vedicinals-9 along with standard care: Vedicinals-9-Active (9 compounds) 5000 mg in Additive 50 ml suspension per day [100 mg/ml suspension] Loading dose on day 1 - 25 ml each at 1 hour before breakfast, lunch and dinner. Maintenance dose from day 2 to day 12 ± 2 days - 20 ml, 15 ml and 15 ml at 1 hour before breakfast, lunch and dinner, respectively. <br><br>Standard Care-as per the Ministry of Health and family welfare guidelines for COVID-19.<br>Control Intervention1: Standard Care: Standard Care as per the Ministry of Health and family welfare guidelines for COVID-19.<br>→ | a) Percentage of COVID-19 patients and time taken to get COVID-19 RT-PCR negative <br/ ><br>b) Time of convalescence and improvement in altered biomarkers post COVID-19 infectionTimepoint: a) Days from admission, days from first testing positive, days from first noticed symptoms <br/ ><br> <br/ ><br>b) At screening, day 5, day 12 and day 45→ | | | | Yes | False | | |
| → | CTRI/2020/10/028363 | 27 January 2021 | The barriers encountered by health-service providers while giving healthcare to patients admitted to COVID hospitals of Odisha | Perceived Barriers in Delivering Optimal Healthcare Services In COVID
Hospitals of Odisha : A Health-service providersâ?? Perspective | | Dr Nipa Singh | 12-10-2020 | 20201012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48039 | Not Recruiting | No | | | | 01-11-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Nipa Singh→ | | Department of Microbiology,
Kalinga Institute of Medical Sciences,
P.O. KIIT,
Bhubaneswar House no. 17,
Laxmi Vihar,
P.O.KIIT, Bhubaneswar→ | nipa.singh@kims.ac.in→ | | Kalinga Institute of Medical Sciences→ | Inclusion criteria: All the healthservice providers aged 18 years or above, working either on a full- or part time basis, able to understand English, and who have worked <br/ ><br>in COVID hospitals and give informed consent will be included in the study.→ | Exclusion criteria: Health service providers who cannot be contacted, who do not have an electronic device with which they can access the internet for completing the <br/ ><br>questionnaire will be excluded.→ | | | To understand the barriers in delivering optimal health care <br/ ><br>to COVID 19 patients.Timepoint: 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/10/028360 | 27 January 2021 | Psychiatric sequelae in COVID-19 infection recovered resident doctors and
interns of a tertiary health care hospital.
| To study the psychiatric sequelae in COVID-19 infection recovered resident doctors and
interns of a tertiary health care hospital.
| | Seth G S Medical College and KEM Hospital Mumbai | 12-10-2020 | 20201012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48352 | Not Recruiting | No | | | | 19-10-2020 | 60 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Neena S Sawant→ | | Department of Psychiatry, Seth GSMC and KEM Hospital, Parel, Mumbai. → | drneenas@yahoo.com→ | 9930583713→ | Seth GSMC and KEM Hospital, Mumbai→ | Inclusion criteria: (A) Resident doctors and Interns who are willing to participate in our study. <br/ ><br>(B) Have suffered from COVID-19 illness in the past 4 months and recovered from it.→ | Exclusion criteria: (A)Those resident doctors /interns who are suspected COVID 19. <br/ ><br>(B) Those who have not yet recovered from the illness and still admitted in hospital or <br/ ><br>are into home quarantine for the same. <br/ ><br>(C) Anyone not consenting to participate in the study. <br/ ><br>→ | | | To determine the psychiatric sequelae if any in the <br/ ><br>resident doctors and interns who have recovered from infectionTimepoint: 1 month→ | | 10/11/2020 | | Yes | False | | |
| → | CTRI/2020/10/028361 | 27 January 2021 | Endothelial Dysfunction in Severe COVID 19 disease | To Study Vascular Endothelial Dysfunction as a marker of severe COVID 19 Related disease | | All India Institute of Medical Science Rishikesh | 12-10-2020 | 20201012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48356 | Not Recruiting | No | | | | 19-10-2020 | 40 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rohit Walia→ | | Room number 25103, Department of Cardiology , All India Institute of Medical Science Rishikesh Pashulok , Virbhadra Road→ | rwalia7731@yahoo.in→ | 8800492549→ | All India Institute of Medical Science Rishikesh→ | Inclusion criteria: COVID 19 infected patients→ | Exclusion criteria: Any other infection except COVID 19 <br/ ><br>Renal failure (CrCl < 60 mL/min/1.73 m2) or need for hemodialysis <br/ ><br>Pregnancy <br/ ><br> Anemia <br/ ><br>Diabetes <br/ ><br>Coronary Artery Disease <br/ ><br> Dyslipidemia <br/ ><br> Smoking→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | Number of patients with endothelial dysfunction preceding severe COVID <br/ ><br>related diseaseTimepoint: 2 months from disease onset→ | | | | Yes | False | | |
| → | CTRI/2020/10/028362 | 27 January 2021 | Study to assess the efficacy of deep breathing Pranayama technique in addition to conventional allopathic treatment in management of COVID19 | â??Introduction of deep breathing Pranayama technique as â??add-onâ?? in management of confirmed cases with COVID 19: A Prospective Study with Retrospective Controlâ??â?? | | Dr Anuja Santosh Kulkarni | 12-10-2020 | 20201012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48109 | Not Recruiting | No | | | | 15-10-2020 | 278 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Anuja Santosh Kulkarni→ | | R.No.05,ENT department,
Jagjivan Ram railway Hospital,
Maratha Mandir Marg,Mumbai Central, Mumbai:400008
Jagjivan Ram railway Hospital,
Maratha Mandir Marg,Mumbai Central, Mumbai:400008
State:Maharashtra→ | dr.anujakulkarni@gmail.com→ | | Jagjivan Ram railway Hospital→ | Inclusion criteria: All adult patients confirmed cases of COVID 19 admitted to our hospital All adult patients Aged 18 years and above upto 99 yrs, irrespective of gender and co morbidities will be included in the study→ | Exclusion criteria: 1)Unconscious patients <br/ ><br>2)Mentally challenged patients <br/ ><br>3)Pregnant Women <br/ ><br>4)Children below age of 18 years <br/ ><br>5)Non compliant to add on technique <br/ ><br>6)Those requiring mechanical ventilator with room air oxygen saturation spo2 <80% and progressive de-saturation <br/ ><br>will be excluded from study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: Deep breathing Pranayama breathing technique(A type of chest physiotherapy), Conventional allopathic treatment: One cycle of Deep breathing Pranayama technique (a type of chest physiotherapy) of 20-22 breaths to be practiced three times a day<br>Preferably on empty stomach i.e. before breakfast, meal and dinner or 2-3 hours after meals<br><br>in addition to conventional allopathic treatment<br> <br><br>Control Intervention1: Conventional allopathic treatment only(Retrospective Control group): The outcomes will be compared to Retrospective control group treated in the same hospital prior to introduction of the add on intervention with 1:1 matching with regards to age, gender, comorbidity,symptoms,stage of illness<br>→ | 1)Length of time to clinical improvement Normalisation of respiratory rate, oxygen saturation, alleviation of cough <br/ ><br>2)Number of participants with normal oxygen saturation on day 11 15 and 21 <br/ ><br>3)Length of time of normalisation of oxygen saturation (Time frame upto 28 days) <br/ ><br>4)Duration of Supplemental Oxygen Time frame :Upto 28 daysTimepoint: Outcomes will be assessed <br/ ><br>at baseline,Day 3, Day 5, 1week(7days) ,2weeks(14 Days), 3weeks(21days) and at 4weeks(28days)→ | | | | Yes | False | | |
| → | CTRI/2020/10/028376 | 27 January 2021 | A Clinical Study to evaluate the safety and efficacy of CoviToneâ?¢ in Mild to moderate Covid patients | A randomized, multi center, open label, parallel-group, comparative, clinical study to evaluate safety and efficacy of CoviToneâ?¢ as an adjuvant to standard of care compared to standard of care alone in mild to moderate COVID-19 symptomatic adult patients. | | Arber Biosciences Pte Ltd | 13-10-2020 | 20201013 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48426 | Not Recruiting | No | | | | 22-10-2020 | 80 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Jestin V Thomas→ | | Department of Clinical Research, #9, 1st floor, Mythri Legacy, Chelekere main road, Kalyan nagar → | jestin.leadsclinbio@gmail.com→ | 9845125293→ | Leads Clinical Research and Bio Services Pvt. Ltd→ | Inclusion criteria: 1.Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab or patient who have tested positive within 5 days of the screening visit <br/ ><br>2. Patients clinically assigned as mild (Patients with uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache without evidence of breathlessness or hypoxia) <br/ ><br>3. Patients clinically assigned as moderate(Pneumonia with no signs of severe disease, respiratory rate â?¥24 breaths/minute, SpO2 <94% (90%-94%) on room air) <br/ ><br>4.Females should have a negative serum pregnancy test at baseline; female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment <br/ ><br>5. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator. <br/ ><br>6. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment <br/ ><br>7. Must be willing and able to give informed consent and comply with the study procedures→ | Exclusion criteria: 1. Patients clinically assigned as having severe COVID-19 disease (Severe Pneumonia (with respiratory rate â?¥30/minute and/or SpO2 < 90% in room air) or Acute Respiratory Distress Syndrome or Septic shock], critically ill patients and those currently requiring or anticipated to imminently require one or more forms of extracorporeal life support (eg mechanical ventilation, extracorporeal membrane oxygenation) in the judgement of the Investigator (on basis of COVID-19 disease severity, rate of progression, co-morbidities or complications) at the time of randomization or during the course of the study) <br/ ><br>2.Patients with history of or one or more known comorbidities at screening (Uncontrolled Hypertension (systolic blood pressure >180 mmHg diastolic blood pressure >100 mmHg), Ischemic Heart Disease, Cardiac Failure , Uncontrolled Diabetes Mellitus ,Chronic obstructive pulmonary disease (COPD), Asthma or Interstitial Lung Disease, Malignancy ,Kidney Disease (Serum creatinine > 1.5 times upper limit) ,Liver disease (e.g. Child Pugh score â?¥ B or AST (Aspartate Transaminase) >4 times upper limit) <br/ ><br>Cardiac conduction delay (QTc > 500 msec) ,Glucose-6-phosphate dehydrogenase (G6PD) deficiency Psoriasis or porphyria ,Other underlying severe diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ ><br>3.In case of patients with symptoms associated with COVID-19 at screening assessment (i.e., one or more of fever, cough, sore throat, breathlessness, rapid respiratory rate, low oxygen saturation in blood, body ache, chills, chills with shaking, fatigue, headache, loss of smell, loss of taste, diarrhoea, nasal congestion or any other symptom considered by the Investigator to be reasonably associated with COVID-19), the first onset of symptoms was > 5 days before screening (not applicable for re-treated/relapsed patients). <br/ ><br>4.History of recent blood donation , Immunodeficiency disease, Allergy, medication or supplement use that influences the immune system. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients , Inability to take oral medication, Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption, ,Concomitant medication/supplement which could affect the study ,Antiviral therapy prior to screening ,Any contraindication to blood sampling <br/ ><br>Patients allergic to herbal products or any component of the study product <br/ ><br>6. Female patients who are pregnant or lactating <br/ ><br>7. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment <br/ ><br>8. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (e.g. Methotrexate, Cyclosporine etc.) <br/ ><br>9. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study <br/ ><br>10. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the patient from completing the study. <br/ ><br> <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: CoviToneâ?¢: Oral administration of CoviToneâ?¢ two times in a day along with standard care of treatment for 5 days<br>Control Intervention1: Standard Care of Treatmenet: As prescribed by the Investigator<br>→ | Changes in Covid-19 symptoms and assessment scalesTimepoint: Screening, Day 1, Day 2, Day 3, Day 4, Day 5, Day 6→ | | | | Yes | False | | |
| → | CTRI/2020/10/028372 | 27 January 2021 | Evaluation of Respiratory profile and radiological changes in patients after recovery from COVID-19 | Evaluation of Respiratory profile and spectrum of radiological abnormalities in patients after recovery from COVID-19 infection | | Anant Mohan | 13-10-2020 | 20201013 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48321 | Not Recruiting | No | | | | 22-10-2020 | 500 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Anant Mohan→ | | Department of Pulmonary, Critical Care and Sleep Medicine, Room no. 5, Porta Cabin, Third floor, New private ward, AIIMS → | anantmohan@yahoo.com→ | 09968859414→ | AIIMS, Delhi→ | Inclusion criteria: 1. Has completed at least 4 weeks since hospital discharge/ RT-PCR negativity <br/ ><br>2. Able to be contacted telephonically and provides verbal consent for evaluation as per study protocol <br/ ><br>→ | Exclusion criteria: Patients not providing consent for participation in the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Nil<br>→ | Forced vital capacityTimepoint: At the time of enrollment <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/10/028373 | 27 January 2021 | "Experiences among nurses caring patients with COVID 19" | Experiences among nurses caring patients with COVID 19: A thematic analysis. | | Dr Leena Sequira | 13-10-2020 | 20201013 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48335 | Not Recruiting | No | | | | 30-10-2020 | 30 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Leena Sequira→ | | Manipal School of Nursing, MCON,Manipal Academy of Higher Education Shankerpura post.
Udupi Taluk and district.
574115→ | leena.sequ@manipal.edu→ | 9481971214→ | Manipal Academy of Higher Education→ | Inclusion criteria: 1. Nurses taking care of patients diagnosed with COVID 19 at least for one week. <br/ ><br>2. Willing to participate in the study. <br/ ><br>→ | Exclusion criteria: 1.Nurses taking care of patients diagnosed with COVID 19 less than one week. <br/ ><br>2.Not willing to participate in the study. <br/ ><br>→ | | | Experiences of giving care to a COVID 19 patientTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/10/028384 | 27 January 2021 | A population based survey on COVID-19 infection in Goa state among both urban and rural population. | Serological pilot study on SARS-CoV2 infection in urban and rural population of Goa state using stratified random sampling. | | CROM Clinical Research Medical Tourism Pvt Ltd | 13-10-2020 | 20201013 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48092 | Not Recruiting | No | | | | 16-10-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Dhananjay Lad→ | | CROM Premises, Building no. 2, Opp. Caculo Mall, St. Inez, Panaji → | clinicalresearchgoa@gmail.com→ | 7775026777→ | CROM Clinical Research & Medical Tourism Pvt. Ltd.→ | Inclusion criteria: 1.Apparently Healthy subjects will be recruited. <br/ ><br> <br/ ><br>2.Subjects of both sexes aged more than 15 years old. <br/ ><br> <br/ ><br>3.Willing and able to provide written informed consent prior to performing study procedures by the subject or legal guardian willing and able to provide written informed consent prior to performing study procedures.→ | Exclusion criteria: 1.Subjects having less than 15 years of age <br/ ><br>2.Critical co-morbidities. <br/ ><br>→ | | | 1. To know the prevalence of infection among urban and rural population.Timepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/10/028412 | 27 January 2021 | school teachers experience in online teaching during this COVID-19 situation | A cross sectional study on teacher experience, stress and coping in online teaching during the pandemic period. | | Manipal Academy of Higher Education Manipal | 14-10-2020 | 20201014 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48163 | Not Recruiting | No | | | | 30-10-2020 | 200 | Observational | Cluster Randomized Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | UMESH THONSE→ | | Department of Psychiatry
Kasturba Medical College, MAHE
Manipal Department of Psychiatry
Kasturba Medical College, MAHE
Manipal→ | umesh.tonse@gmail.com→ | 9743579781→ | Kasturba Medical College Manipal→ | Inclusion criteria: (1)Kannada Medium or English Medium Primary and high school teachers of <br/ ><br>selected schools of Udupi Taluk private or government schools (2) Minimum 1 year of regular <br/ ><br>teaching experience and adapted new methods of teaching (3)Teachers who give their consent <br/ ><br>for the study <br/ ><br>→ | Exclusion criteria: Teachers who do not give their consent for the study will be not taken into <br/ ><br>the study. <br/ ><br>→ | | | In this study outcome measures are teachers experience during online mode of teaching, their <br/ ><br>stress associated with this. Also this study will be assessing teachers coping mechanisms to <br/ ><br>overcome from this stress.Timepoint: only one time point→ | | | | Yes | False | | |
| → | CTRI/2020/10/028422 | 27 January 2021 | Effect of COVID 19 on lymphocyte and eosinophil count | CORRELATION OF ABSOLUTE EOSINOPHIL AND LYMPHOCYTE COUNTS IN SEVERITY OF COVID -19 PATIENTS: A PROSPECTIVE STUDY | | AIIMS Patna | 15-10-2020 | 20201015 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47424 | Not Recruiting | No | | | | 24-10-2020 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DR AMARJEET KUMAR→ | | 5th Floor, B-BLOCK, OT complex, ROOM NO.-503, AIIMS Patna.
BIHAR
801507
India 5th Floor, B-BLOCK, OT complex, ROOM NO.-503, AIIMS Patna.
BIHAR
801507
India→ | amarjeetdmch@gmail.com→ | 9570890646→ | AIIMS PATNA→ | Inclusion criteria: All adult (age group >18) COVID positive patients getting admitted in our hospital would be recruited for the study.→ | Exclusion criteria: Pregnant patients, blood malignancies, hereditary eosinophilic syndrome, or any other condition that can affect eosinophil/ lymphocyte count→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To evaluate the relationship between blood cells parameters (EOS, lymphocyte, Lymphocyte/neutrophil ratio) and disease severity.Timepoint: 4 month→ | | | | Yes | False | | |
| → | CTRI/2020/10/028414 | 27 January 2021 | Clinical study of an Ayurveda formulation containing Gold and Indian Gooseberry along with Tulasi juice as an add on therapy in standard care of COVID 19 patients | Study of Swarna Amalaki as an immunomodulator in Covid-19 Patients | | Ministry of AYUSH New Delhi | 15-10-2020 | 20201015 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48010 | Not Recruiting | No | | | | 02-11-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | Phase 2 | India→ | Jyothy K B→ | | Mahatma Gandhi Ayurved College, Hospital & Research Centre, Salod (H)
Constituent College of Datta Meghe Institute of Medical Sciences Deemed to be University, Wardha
→ | jyothy.kb@dmimsu.edu.in→ | 07776014076→ | Department of Kaumarabhritya→ | Inclusion criteria: 1. Diagnosed patients of COVID 19with positive RT-PCR test of either sex, between the age group of 20 -70 years <br/ ><br>2. Patients of COVID 19 receiving standard treatment protocol as prescribed by ICMR/MOHFW, Govt. of India <br/ ><br>3. Patients giving informed consent <br/ ><br>→ | Exclusion criteria: 1. COVID 19 patients requiring ventilator support <br/ ><br>2. Pregnant ladies and children <br/ ><br>3. COVID 19 patients with other severe, unstable, uncontrolled co-morbid medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other diseases of concern which may put the patient in risk during the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Swarna Amalaki as an adjuvant therapy: Swarna Amalaki as an adjuvant therapy to standard management of COVID-19 containing Swarna Bhasma- 30mg/day and Amalaki Churna â?? 3gms/day triturated along with fresh juice of Tulasi leaves in powder form will be administered along with honey and ghee once a day in the morning on empty stomach for a period of 28 days.<br>Control Intervention1: Standard management of COVID 19: Standard management as per the ICMR/ MOHFW, Govt. of India/Maharashtra guidelines<br>→ | Early recovery from clinical signs and symptoms such as cough, cold, fever and associated symptoms of COVID 19 without further complications <br/ ><br> <br/ ><br>Negative result for COVID 19 testTimepoint: Baseline,Day7,14,21and 28→ | | | | Yes | False | | |
| → | CTRI/2020/10/028423 | 27 January 2021 | A clinical study to see the effects and safety of PNB-001 in patients with moderate COVID-19 infection | A Randomized, Open label Clinical Study to Evaluate Efficacy and Safety of PNB-001 in Patients with moderate COVID-19 Infection. | | PNB Vesper Life Science Pvt Ltd | 15-10-2020 | 20201015 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47514 | Recruiting | No | | | | 28-10-2020 | 40 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2 | India→ | Dr Neeta Nargundkar→ | | Office No. 02, 03 & 04, Second Floor,
Highland Corporate Center,
Kapurbawdi Junction, Thane (W),Maharashtra, India
→ | drneeta@biospherecro.com→ | 91-22-41006794→ | Biosphere Clinical Research Pvt.Ltd.→ | Inclusion criteria: 1. Male or female patients aged between 18 and 65 years (both Inclusive). <br/ ><br>2. Patients with laboratory-confirmed SARS-CoV-2 infection as determined by PCR within 2 days of randomization. <br/ ><br>3. Patients havingPneumonia with no signs of severe disease with SpO2 â?¤94% (range 90-94%) on room air. <br/ ><br>4. Patients with any two of the following signs or symptoms suggestive of COVID-19. <br/ ><br> - Fever <br/ ><br> - Cough <br/ ><br> - dyspnoea or hypoxia <br/ ><br> - Respiratory rate more or equal to 24 per minute. <br/ ><br>5. Radiographic infiltrates as confirmed by imaging (chest xray). <br/ ><br>6. Patients who are willing to sign written informed consent for participation in the study and willing to adhere to all protocol procedures. <br/ ><br>7. Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment.→ | Exclusion criteria: 1. Patient requiring invasive mechanical ventilation. <br/ ><br>2. Known allergies, hypersensitivity, or intolerance to investigational product or its excipients. <br/ ><br>3. Patients with the following clinically significant laboratory abnormalities: SGOT, SGPT, Serum Bilirubin > 2.5 times the Upper Limit Normal (ULN)) at screening visit. <br/ ><br>4. Patients with abnormal Sr.Creatinine value of â?¥ 2 mg/dl at screening visit. <br/ ><br>5. Patients with Type 1 diabetes mellitus. <br/ ><br>6. Patients with uncontrolled Type 2 diabetes mellitus with random sugar â?¥ 200 mg/dL. <br/ ><br>7. Uncontrolled hypertension (systolic blood pressure > 160mmHg, or diastolic blood pressure >100mmHg); previous history of hypertension crisis or hypertensive encephalopathy. <br/ ><br>8. History or presence of clinically significant hepatic, renal,cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, diseases or metabolic disturbances or other relevant systemic diseases that would preclude the safe administration of the Investigational product. <br/ ><br>9. Any condition for which, in the opinion of the investigator,participation would not be in the best interest of the patient (eg, compromise the well-being) or that could prevent, limit,or confound the protocol-specified assessments. <br/ ><br>10. History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive, or other clinically active liver disease. <br/ ><br>11. History of human immunodeficiency virus (HIV) antibody positive. <br/ ><br>12. History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSMV) criteria within 1 years before Screening. <br/ ><br>13. History of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. <br/ ><br>14. Poorly controlled heart diseases, such as NYHA class II and above cardiac insufficiency, unstable angina pectoris,myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia need treatment or intervention. <br/ ><br>15. Patient received an investigational intervention (including investigational vaccines) or used an invasive investigational <br/ ><br>medical device within 30 days or 5 half-lives prior to Baseline, whichever is longer, before the signing the consent or is currently enrolled in an investigational study. <br/ ><br>16. Pregnant or breast-feeding at screening. <br/ ><br>17. Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: PNB-001 with Standard of care treatment as per the revised clinical management protocol for COVID-19 as issued by Govt of India, MoHFW: PNB-001 100 mg capsule three times a day with standard of care treatment for 14 days<br>Control Intervention1: Standard of care treatment as per the revised clinical management protocol for COVID-19 as issued by Govt of India, MoHFW: 14 days<br>Control Intervention2: Standard of care treatment as per the revised clinical management protocol for COVID-19 as issued by Govt of India, MoHFW: 14 Days<br>→ | 1.Mean change in the ordinal scale from baseline. <br/ ><br>2.Mortality Rate by Day 28Timepoint: 15 Days <br/ ><br>28 Days→ | | | | Yes | False | | |
| → | CTRI/2020/10/028424 | 27 January 2021 | Clinical study to evaluate the effect of Ayurveda intervention as a prophylaxis for COVID-19 in Healthcare workers | â??Pre-Exposure, Ayurveda Prophylaxis For COVID-19 In Healthcare Workers: A Pragmatic, Risk Stratified, Randomized Clinical Trialâ?? - PRASACT | | Ministry Of AYUSH Government of India | 15-10-2020 | 20201015 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48294 | Not Recruiting | No | | | | 30-10-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 3 | India→ | Dr Zankhana Buch→ | | #230, Amarjyoti Layout, Domlur Extn.
Intermediate Ring Road
Bangalore
→ | zankhana_buch@ayurvaid.com→ | | AyurVAID Hospitals→ | Inclusion criteria: 1.Consenting Healthcare Workers at Aster CMI Hospital <br/ ><br>2.HCWs with Active Asthma/ Bronchitis/ COPD but not on any internal medication. <br/ ><br>3.Willingness/Consent to participate in the Trial <br/ ><br>4.18 years and older <br/ ><br>→ | Exclusion criteria: 1.Active COVID-19 disease <br/ ><br>2.Prior COVID-19 disease <br/ ><br>3.Pregnant Women and Breast feeding Mother <br/ ><br>4.Children Below 1 year <br/ ><br>5.HIV <br/ ><br>6.Organ Donors <br/ ><br>7.Patients with Organ Transplant <br/ ><br>8.Participation in any other COVID-19/COPD Trial <br/ ><br>9.Patients with Active Malignancy <br/ ><br>10.Patients with Chronic Kidney with GFR <30 <br/ ><br>11.Patients with Bleeding Disorders <br/ ><br>12.Patients with Active Upper or Lower Respiratory Tract Infection Disorders on any Allopathy Internal Medication <br/ ><br>13.Health care workers who are on HCQ medication <br/ ><br>→ | | Intervention1: Classical Ayurveda Intervention (Ahara-Vihara-Aushadha): Sudarshana Ghana Vati (0-1-1) AF (after food),Dhanvantaram Gutika (0-1-1) AF (after food)<br>Chywanaprasha 1 tsp twice daily at 9 am and 5 pm, GuduchyAdi Kashayam Prakshepa 15 Ml + 45 Ml boiled and cooled water @ 6 am/6 pm,Amritotaram Kashayam Prakshepa, Dasamoola Katutrayam Kashayam,Haridrakhandam (1 tsp with hot water BD, Indukantam Kashayam Before Food), ElaKanAdi Ks, Vasaristam+Kanakasavam(10+10 ml, after meals) Nayopayam KS Prakshepa, VidAryAdi KS (15 ml with 45 ml hot water,KalyAnagulam (10 gm at bedtime<br>Control Intervention1: Ayurveda Diet and lifestyle prescription: diet+lifestyle<br>→ | % Of staff members who develop NCMP Stages, by stage, within 1month/2months/3months of enrolment into study. <br/ ><br>COVID-19-free survivalTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/10/028439 | 27 January 2021 | Secondary attack rate of COVID-19 and risk factors for transmission | Secondary attack rate of COVID-19 and risk factors for transmission | | Manisha Arthur | 16-10-2020 | 20201016 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44034 | Not Recruiting | No | | | | 16-10-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Manisha Arthur→ | | Department of General Medicine, SRIHER, Porur, Chennai → | manisha_arthur@yahoo.co.in→ | | Sri Ramachandra institute of higher education and research, Chennai→ | Inclusion criteria: All COVID positive patients→ | Exclusion criteria: Nil→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Not applicable: Not applicable<br>→ | Secondary attack rate of COVID 19Timepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/10/028437 | 27 January 2021 | Effect of Ayurvedic Treatment Regimen in COVID-19 Patients | A Clinical Evaluation of Efficacy of Ayurvedic treatment regimen as an Add-on therapy with Modern Medicine in COVID 19 - A Randomized, Multi-center, Single Blind, Prospective Clinical Study | | Ministry of AYUSH | 16-10-2020 | 20201016 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47956 | Not Recruiting | No | | | | 02-11-2020 | 380 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant Blinded | Phase 3 | India→ | Dr Milind B Nikumbh→ | | Department of Rachana Sharir,
Government Ayurved College
Gulabrao Deokar Engineering College Campus Shirsoli Road Jalgaon → | drnikumbh@gmail.com→ | | Government Ayurved College, Jalgaon→ | Inclusion criteria: 1. All hospitalized cases above 18 years of age, clinically diagnosed with corona virus disease 2019 and presenting with mild to moderate signs and symptoms of COVID-19, quarantined at identified hospital set up. <br/ ><br>2. Participants who can take medicines orally. <br/ ><br>3. Patients willing to provide signed informed consent.→ | Exclusion criteria: 1. Cases of severe vomiting which would affect oral administration of medicine difficult. <br/ ><br>2. Cases of respiratory failure and requiring mechanical ventilation. <br/ ><br>3. Combined organ failure requiring ICU monitoring. <br/ ><br>4. Pregnant and lactating women. <br/ ><br>5. Subjects having an active malignancy. <br/ ><br>6. Subjects giving history of significant cardiovascular event < 12 weeks prior to randomization. <br/ ><br>7. Subjects having a chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV. <br/ ><br>8. Subjects having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes. <br/ ><br>9. Any other condition, which as per the investigator would jeopardize the outcome of the trial.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 1. Bilwadi Yog <br>2. Kantakaryavaleha <br>3. Shadangodak: 1. Bilwadi Yog - 1 gm BID<br>2. Kantakaryavaleha - 3 gm BID<br>3. Shadangodak - 40 ml BID<br><br>Total Duration of the Therapy - 15 Days<br>Control Intervention1: Conventional Modern Medicine: Conventional Modern Medicine<br><br>Total Duration of the Therapy - 15 Days<br>→ | 1. Clinical cure rate: Time to negative conversion of severe acute respiratory syndrome corona-virus 2 (defined as viral load of respiratory specimen negative for two consecutive times when tested in an interval of two days)Timepoint: 3 Months→ | | | | Yes | False | | |
| → | CTRI/2020/10/028432 | 27 January 2021 | Mental health of COVID 19 patients during outbreak | STRESS AND PSYCHOLOGICAL IMPACT ON SARS COVID 19 PATIENTS DURING THE OUTBREAK | | All India Institute of Ayurveda | 16-10-2020 | 20201016 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48231 | Not Recruiting | No | | | | 16-10-2020 | 400 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Shivakumar Harti→ | | 6th Floor room no.622
Department of swasthvritta
All India Institute of Ayurveda
Mathura road Gautam puri awas Sarita Vihar New Delhi → | shivakumarsharti@gmail.com→ | 9611275434→ | All India Institute of Ayurveda Sarita Vihar New Delhi→ | Inclusion criteria: Patients tested positive for COVID 19 by RTPCR test with no comorbidities→ | Exclusion criteria: Participants unwilling to participate <br/ ><br>Vulnerable and high risk groups→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: nil: nil<br>Control Intervention1: nil: nil<br>→ | The study would give a level of depression, anxiety and stress in patients with SARS COVID 19Timepoint: At baseline→ | | | | Yes | False | | |
| → | CTRI/2020/10/028438 | 27 January 2021 | Perspective of cancer patient in COVID-19 pandemic | Perspective of cancer patient in COVID-19 pandemic: an obsevational study | | nil | 16-10-2020 | 20201016 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48532 | Not Recruiting | No | | | | 01-12-2020 | 1000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Shabnum Thakur→ | | room no.: 31, 3rd floor, TCC IGMC Shimla room no.: 31, 3rd floor, TCC IGMC Shimla→ | thakurshabnum7@gmail.com→ | 9459830966→ | IGMC Shimla→ | Inclusion criteria: Ability to read, write, or comprehend spoken language will be a prerequisite for entry into this study. The questionnaire will be filled out by either the patient or a family member if the patient is unable to read. <br/ ><br>→ | Exclusion criteria: Patients will be excluded if they are in severe physical distress because of cancer or therapy- related complications, in altered sensorium, are not receiving any active systemic therapy and oral targeted therapy, has no evidence of disease recurrence or progression, are planned only for best supportive care, and are being considered an inpatient admission for supportive care. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | The primary end point of study will be the proportion of patients who wish to continue or discontinue systemic therapy/ radiotherapy/ chemo-radiotherapy during the pandemic. <br/ ><br>Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/10/028436 | 27 January 2021 | This study is designed to look at certain blood parameters like biomarkers for predicting the outcome of COVID patients | Role of Biomarkers and itâ??s trend to predict the outcome of COVID patients, retrospective review | | Dr Amarja Havaldar | 16-10-2020 | 20201016 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47604 | Not Recruiting | No | | | | 25-10-2020 | 130 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Amarja Havaldar→ | | Department of Critical care medicine St Johns Hospital Bangalore
→ | amarjahavaldar@rediffmail.com→ | 9036082112→ | St Johns Medical college→ | Inclusion criteria: Patients with COVID 19 pneumonia admitted in ICU→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To study the trend of biomarkers and itâ??s effect on outcome (ICU mortality)in patients admitted with the diagnosis of COVID pneumonia.Timepoint: ICU mortality or at the end of 4 weeks <br/ ><br>Hospital mortality or at the end of 90 days→ | | | | Yes | False | | |
| → | CTRI/2020/10/028472 | 27 January 2021 | Study of Edaravone as adjunctive treatment in COVID | Adjunctive Edaravone for Covid Treatment: A Prospective Randomised Control Pilot Study - COVAED | | Sparsh Foundation | 19-10-2020 | 20201019 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47524 | Not Recruiting | No | | | | 29-10-2020 | 40 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr John Paul M→ | | number 4/1 tumkur road yeshwanthpur
Bangalore number 4/1 tumkur road yeshwanthpur
Bangalore 560022→ | drjohnpaulm@gmail.com→ | 08028392613→ | Sparsh Hospital→ | Inclusion criteria: Male and female above 18 years till 65 years with moderate COVID Disease→ | Exclusion criteria: Patients with pre-existing kidney and liver diseases. <br/ ><br>Pregnant and lactating women <br/ ><br>Patients with hyperreactive airway disease and obstructive airway disease. <br/ ><br>Patients with co-infections. <br/ ><br>Immunocompromised patients, either by disease condition(HIV-AIDS..etc) or by drugs( immunomodulators..etc) <br/ ><br>Patients who are declining to give consent <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Injection Edaravone 60mg: IV infusion over one hour<br>for seven days Along with Standard of care as per ICMR guidelines for COVID treatment<br><br>Control Intervention1: Standard of care Plus Placebo: Standard of care for COVID disease as per ICMR guidelines<br>And<br>Placebo will have Normal Saline IV infusion over one hour for seven days<br>→ | 1) Mortality <br/ ><br>2) Change in clinical progression of the disease recorded using the WHO approved 8 point ordinal scale <br/ ><br>3) Change in markers of inflammation.- IL-6,CRP,Ferritin, D-dimer AND LDHTimepoint: 1) Mortality at 28 days <br/ ><br>2) Change in clinical progression of the disease recorded using the WHO approved 8 point ordinal scale <br/ ><br>3) Change in markers of inflammation.- IL-6,CRP,Ferritin, D-dimer AND LDH on Day 4 Day 7 and Day 10.→ | | | | Yes | False | | |
| → | CTRI/2020/10/028470 | 27 January 2021 | Relation of lung disease and smoking with the severity of COVID-19 in a district hospital of Pune city, Maharashtra | Association of COPD and smoking history with the severity of COVID-19 in a tertiary care center of Pune city, Maharashtra | | NIL | 19-10-2020 | 20201019 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47547 | Not Recruiting | No | | | | 26-10-2020 | 489 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | MINAL HATNAPURE→ | | Department of Community Medicine BJGMC Pune Department of Community Medicine BJGMC Pune→ | drparandemalan@gmail.com→ | 9850131337→ | B. J. Govt. Medical College and Sassoon General Hospital, Pune→ | Inclusion criteria: All the laboratory confirmed Covid19 cases will be enrolled after taking informed consent and detailed history will be taken from the patient or the relatives of the patient.→ | Exclusion criteria: All Covid19 antibody positive and home isolated patients and patients below 18 years of age will be excluded from the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Severity of Covid 19 as an outcome in the form of discharge or deathTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/10/028471 | 27 January 2021 | Effect of the drug â??Immuneâ??- an Ayurveda medication in COVID-19 patients
| Immunological Effect of the drug â??Immuneâ??- an Ayurveda medication in COVID-19 patients
| | NGR Vishnu Sri | 19-10-2020 | 20201019 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48593 | Not Recruiting | No | | | | 02-11-2020 | 50 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Alternation Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Sailaja Vani→ | | Department- AYUSH
Division- Ayurveda
Room no-15, 5th floor, OPD Block, Esic medical college and hospital
7-1-634, survey no.121/1, National highway 65, Sanjeev reddy nagar , Sanathnagar, Hyderabad → | dr.sudhabala78@gmail.com→ | 7702031889→ | ESIC Medical college, Sanathnagar, Hyderabad→ | Inclusion criteria: Mild to Moderate COVID- 19 confirmed patients of age greater than 20 years and upto 58 years and willing to participate with consent <br/ ><br>→ | Exclusion criteria: Who are not willing to participate, with co-morbidities, pregnant and lactating women→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B999- Unspecified infectious disease
→ | Intervention1: Immune-combination of Devadaaru, Aswagandha, Yashthimadu and Jeevanthi which are already proven drugs: 6 drops in 50 ml of water every 4 hours <br>Administered for 15 days<br><br>Control Intervention1: placebo-distilled water: 6 drops in 50 ml of water every 4 hours <br>administered for 15 days<br><br>→ | To detect the rise in antibody titre with the drug intake and reduction in inflammatory markers with the drug intake.Timepoint: 2 months→ | | | | Yes | False | | |
| → | CTRI/2020/10/028486 | 27 January 2021 | Yoga for COVID-19 Patients with mild symptoms | EFFICACY OF INTEGRATED YOGA INTERVENTION ON PHYSIOLOGICAL AND PSYCHOLOGICAL OUTCOMES OF COVID-19 PATIENTS WITH MILD SYMPTOMS | | Pragya Jain Shrimal | 20-10-2020 | 20201020 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48223 | Not Recruiting | No | | | | 02-11-2020 | 50 | Interventional | Other<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Other Blinding and masking:Not Applicable | Phase 1 | India→ | Pragya Jain Shrimal→ | | Department of yoga and life science, Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Anekal, Jigani,Bangalore 220, Clerk Colony
Opp to Bhandari Hospital
Pardeshi Pura, Indore (Madhya Pradesha) - 452003→ | trisatyapriya77@gmail.com→ | 8618587448→ | Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Bangalore→ | Inclusion criteria: 1) Only COVID-19 positives confirmed by RT-PCR method to be recruited. <br/ ><br>2)Patients who are affected by the coronavirus (COVID-19) and are in hospital confinement. <br/ ><br>3) Patients with mild symptoms which may include: uncomplicated upper respiratory tract viral infection symptoms such as fever, fatigue, cough (with or without sputum production), anorexia, malaise, muscle pain, sore throat, dyspnoea, nasal congestion, or headache. <br/ ><br>4)Inclusion of symptomatic patients. <br/ ><br>→ | Exclusion criteria: 1) Unwilling for participation. <br/ ><br>2) Physical and mental disability. <br/ ><br>3) Medical restriction for physical movement. <br/ ><br>4) History of recent surgery. <br/ ><br>5) Patients with Pneumonia, Acute Respiratory Distress Syndrome (ARDS) & patients admitted in Intensive Care Units (ICU). <br/ ><br>6) Pregnant females. <br/ ><br>7) Patients with severe co-morbid conditions (Congestive Heart failure, Uncontrolled Diabetes, Renal failure on hemodialysis, Cancer patients).→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Yoga modules for management of coronavirus disease 2019 (Self-as-control): Patients will be given orientation of tele based yoga practice for a period of 4 days, for two sessions of 15 minutes each with the help of Television in their respective wards. In this, morning sessions of 15 minutes will be practice under the observation of medical staff and in the evening they will do self-practice for 15 minutes. After completing four days of familiarization of practices, on 5th day we will randomize the patients into two groups (Group A & Group B). On the 5th day Group A will be given 15 minutes of tele based yoga intervention and on 6th day Group B will be given 15 minutes tele based yoga intervention.<br>Intervention2: Study -2 : Yoga modules for management of coronavirus disease 2019: Study-2 : Tele Based Yoga protocol for 7 days, 30 minutes/days.<br>Control Intervention1: Control Group Participants - Routine care activity (Self-as-control): Patients will be given orientation of tele based yoga practice for a period of 4 days, for two sessions of 15 minutes each with the help of Television in their respective wards. In this, morning sessions of 15 minutes will be practice under the observation of medical staff and in the evening they will do self-practice for 15 minutes. After completing four days of familiarization of practices, on 5th day we will randomize the patients into two groups (Group A & Group B).On the 5th day Group B will do their routine activity of 15 minutes and on 6th day Group A will do their routine activity of 15 minutes.<br>Control Intervention2: Study -2 : Control Group participants - Routine activity<br>: Study-2 : Routine Care<br>→ | Oxygen Saturation, Heart Rate, Respiratory Rate and Blood pressure <br/ ><br>Timepoint: Day 5th and Day 6th <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/10/028489 | 27 January 2021 | To study the relationship of COVID-19 severity with blood vessels | To study the relationship of
COVID-19 Severity with Arterial Stiffness:
A Prospective Observational Study
- COSEVAST study | | AIIMS Patna | 20-10-2020 | 20201020 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48502 | Not Recruiting | No | | | | 26-10-2020 | 75 | Observational | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India→ | Neeraj Kumar→ | | Room no.503
5th Floor OT Complex
IPD,B-Block
AIIMS Patna Clinical coordinator-COVID-19
COVID-19 office
Left wing Admin Building
AIIMS Patna
Bihar→ | Neeraj.jlnmc@gmail.com→ | 8210104972→ | AIIMS Patna→ | Inclusion criteria: 1. RT PCR proved COVID-19 positive patients admitted in AIIMS Patna <br/ ><br>2. Age â?¥ 18 years <br/ ><br>3. Clinical Category of Patients <br/ ><br>4. Participants who are willing to provide informed consent and willing to undergo the PeriScope test <br/ ><br>→ | Exclusion criteria: 1. Patients with severe CAD, <br/ ><br>2. Congestive heart failure CHF <br/ ><br>3. Hypertension, <br/ ><br>4. Patients on insulin, diabetic neuropathy, <br/ ><br>5. Diabetic Keto acidosis <br/ ><br>6. Stroke and peripheral arterial disorder <br/ ><br>7. Pre-existing Cardiovascular disease <br/ ><br>8. Severe Hypertension <br/ ><br>9. Recent MI <br/ ><br>10. Cardiac transplant within the last 12 months <br/ ><br>11. Pregnancy <br/ ><br>12. Patient with peripheral Edema <br/ ><br>13. Patient with Cardiac Arrhythmia <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: To study if measurement of arterial stiffness using Pulse Wave velocity in mild group of COVID-19 Patients can stratify Cardiovascular risk.: To study if measurement of arterial stiffness using Pulse Wave velocity in mild group of COVID-19 Patients<br>Control Intervention1: We will measure arterial stiffness using Pulse Wave velocity in moderate and severe group of COVID-19 Patients can stratify Cardiovascular risk: We measure arterial stiffness using Pulse Wave velocity in moderate and severe group of COVID-19 Patients can stratify Cardiovascular risk based on various variables.<br>Control Intervention2: Nil: As it is a observational study.<br>Control Intervention3: Nil: As it is a observational study.<br>→ | To study if measurement of arterial stiffness using Pulse Wave velocity in mild.moderate and severe group of COVID-19 Patients can stratify Cardiovascular risk.Timepoint: 0 Day, 2nd Day, 4th Day, 6th Day, 8th Day and 10th Day or on the day of clinical deterioration (change in category to moderate/severe) which ever is earlier. <br/ ><br> <br/ ><br> <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/10/028488 | 27 January 2021 | Role of blood cellular mechanism in severity of COVID-19 | A case control study to evaluate the role of NETosis in severity of COVID-19 patients - NETSCOV TRIAL | | All India Institute of Medical Sciences Patna India | 20-10-2020 | 20201020 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48575 | Not Recruiting | No | | | | 26-10-2020 | 60 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Abhyuday Kumar→ | | Room No. 15, Dept. of Anaesthesiology, Phulwarisarif, AIIMS Patna → | drabhyu@gmail.com→ | 9013512403→ | All India Institute of Medical Sciences→ | Inclusion criteria: COVID positive patients→ | Exclusion criteria: Known autoimmune diseases or carcinoma <br/ ><br>Pregnancy <br/ ><br>History of severe systemic illness→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | | <br/ ><br>Relationship between markers of NETosis (Myeloperoxidase, Elastase, Citrullinated histones and severity of COVID-19 <br/ ><br>Timepoint: Change in the clinical category of patient according to the severity→ | | | | Yes | False | | |
| → | CTRI/2020/10/028485 | 27 January 2021 | Yoga for COVID-19 healthcare workers | EFFICACY OF INTEGRATED YOGA INTERVENTION ON PHYSIOLOGICAL AND PSYCHOLOGICAL OUTCOMES OF COVID-19 HEALTHCARE WORKERS | | Pragya Jain Shrimal | 20-10-2020 | 20201020 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48619 | Not Recruiting | No | | | | 02-11-2020 | 100 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Not Applicable | Phase 1 | India→ | Pragya Jain Shrimal→ | | Department of yoga and life science, Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Anekal, Jigani, Bangalore → | trisatyapriya77@gmail.com→ | 8618587448→ | Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Bangalore→ | Inclusion criteria: 1) Inclusion of population working in COVID-19 healthcare setup in MTH Hospital Indore. <br/ ><br>2) Including Doctors, Nursing staff and Nursing orderly.→ | Exclusion criteria: 1) Unwilling for participation. <br/ ><br>2) Medical restriction for physical movement. <br/ ><br>3) History of recent surgery. <br/ ><br>4) Severe Comorbid conditions (Uncontrolled Diabetes, Uncontrolled Hypertension and Cardiac diseases, COPD etc.) <br/ ><br>5) Pregnant women. <br/ ><br>→ | | Intervention1: Yoga modules for management of coronavirus disease 2019: Integrated yoga-based intervention - delivered for 1 month. Supervised classes will be conducted for 60 minutes every Sunday by Yoga therapist to teach the techniques of Yoga. Participants will be provided Flow charts, Diagrams & Audio-Visual aid for doing self-practice every day for a minimum of 20 minutes at least 3 days per week. Participants will be provided a Monthly chart & Pen to maintain record of their self-practice.<br>Control Intervention1: Control Group Participants - Routine care activity: Participants in the control group will follow their Routine care activity.<br>→ | Oxygen Saturation, Heart Rate, Respiratory Rate and Blood pressureTimepoint: Day 1 and Day 30→ | | | | Yes | False | | |
| → | CTRI/2020/10/028487 | 27 January 2021 | To Study the safety of Remdesivir in COVID-19 Patients. | Adverse Drug Reaction profile of Remdesivir in COVID-19 patients: A Cohort Event Monitoring Study. - CEMS | | AIIMS Patna | 20-10-2020 | 20201020 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48636 | Not Recruiting | No | | | | 30-10-2020 | 100 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Aakanksha Priya→ | | 2nd floor, Department of Pharmacology, Administrative Building, AIIMS, Patna, Bihar AIIMS Patna.→ | drshrutis@aiimspatna.org→ | 7739277734→ | AIIMS, Patna→ | Inclusion criteria: 2. Laboratory (RT-PCR) confirmed COVID-19. <br/ ><br>3. Lung involvement confirmed with chest imaging <br/ ><br>4. Hospitalized with a SaO2/SPO2â?¤94% on room air or Pa02/Fi02 ratio <300mgHg. <br/ ><br>5. Willingness of study participant to take part in this study. <br/ ><br>→ | Exclusion criteria: 3. Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: J128- Other viral pneumonia
→ | | 1. To assess the frequency and pattern of subjective ADRs. <br/ ><br>2. To analyse and interpret the objective ADRs through derangements in lab values. <br/ ><br>Timepoint: 3 months <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/10/028523 | 27 January 2021 | Hematological and biochemical abnormalities parameters in the severity of COVID-19 | The abnormalities in hematological and biochemical parameters and correlation evaluation between laboratory examinations and the severity of COVID-19. | | Parumkhswami Medicall College and Shree Krishna Hospital | 21-10-2020 | 20201021 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48500 | Not Recruiting | No | | | | 30-10-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:On-site computer system Blinding and masking:Investigator Blinded | N/A | India→ | Dr Abdulrahman Amer→ | | Biochemistry Department,Pramukhswami Medical College, Karamsad 388325 → | hiteshns@charutarhealth.org→ | 9825357205→ | Pramukhswami Medical College, Karamsad→ | Inclusion criteria: Patients with positive RT-PCR for COVID-19→ | Exclusion criteria: Patients with positive serology without conformed by RT-PCR for COVID-19.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B998- Other infectious disease
→ | | To investigate the ability of C-reactive protein (CRP), ferritin, interleukin-6 (IL-6), and procalcitonin (PCT) to predict mild and severe cases of COVID-19.Timepoint: Three month→ | | | | Yes | False | | |
| → | CTRI/2020/10/028525 | 27 January 2021 | A study of association of chest x ray with clinical severity in hospitalised covid19 patients | Chest x ray findings with clinical severity in hospitalized COVID19 patients | | Nandakrishna B | 21-10-2020 | 20201021 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48521 | Not Recruiting | No | | | | 31-10-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Nandakrishna B→ | | Department of Medicine
Kasturba Medical College
Manipal Academy of Higher Education, Manipal → | nandaksb@gmail.com→ | 9914201838→ | Kasturba Medical College, Manipal Academy of Higher Education→ | Inclusion criteria: Adults, age > 18 hospitalized with Covid 19→ | Exclusion criteria: Pregnant females <br/ ><br>Subjects already treated with steroids and anticoagulation prior to hospitalizatiNot consenting to the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Chest x ray findings will be classified as mild, moderate and severe and will be compared with clinical severity of ARDS in covid 19 patientsTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/10/028524 | 27 January 2021 | Impact of Covid-19 on mental health among health care workers.
| Impact of Covid-19 on mental health and secondary traumatization among health care workers.
| | nil | 21-10-2020 | 20201021 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48550 | Not Recruiting | No | | | | 01-12-2020 | 632 | Observational | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Shabnum Thakur→ | | Room no. 31, 3rd floor, tertiary care cancer center
IGMC Shimla → | thakurshabnum7@gmail.com→ | 9459830966→ | IGMC Shimla→ | Inclusion criteria: The health care worker (frontline health worker / back ground health worker) wish to participate and able to further share the survey links in social groups. Participant should know how to use social network groups (whatâ??s-app and email). <br/ ><br>→ | Exclusion criteria: The participants fail to submit their survey with in the set time duration of six months (December 2020 to May 2020). <br/ ><br>→ | | | 1. To study the differences in secondary traumas experienced by the frontline workers (doctors and nurses working with COVID-19 patients) and by the background health care professionals( doctors and nurses working with non â??COVID-19 patients). <br/ ><br>Our results aim to help in the early recognition and remedying of secondary trauma in health care professionals, as well as identifying the important risk factors for future research. <br/ ><br>Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/10/028520 | 27 January 2021 | Challenges faced by PG students in conducting research | Challenges faced by the researcher in conducting research during the COVID-19 pandemic at MAHE. | | Dr Divya Karanth | 21-10-2020 | 20201021 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48305 | Not Recruiting | No | | | | 26-10-2020 | 800 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Divya Karanth→ | | Romm no. 8, TMA pai building,Kasturba Medical College and Hospital, Manipal, Udupi- 576104 → | divya.karanth@manipal.edu→ | 08073728795→ | Kasturba Medical college and Hospital→ | Inclusion criteria: 1. All the Postgraduates in the departments of KMC who are involved in the research during the year 2020. <br/ ><br>2. IEC members who are involved in the review of the studies during the COVID-19 pandemic→ | Exclusion criteria: Other researchers who are not doing PG in the departments of KMC→ | | Intervention1: Nil: Nil (Observational study)<br>Control Intervention1: Nil: Nil (observational study)<br>→ | The outcomes studied included Challenges faced by the PG researcher and IEC members during COVID-19 and suggestions in improving the condition.Timepoint: 4-8 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/10/028547 | 27 January 2021 | IND02 for prevention against SARS-CoV-2 Infection: A Randomized controlled study in moderate to high risk population | Evaluation of intranasal application of IND02 for the prophylaxis against SARS-COV-2 infections in moderate to high risk population: A double blind placebo-controlled clinical study (IND02) | | Indus Biotech Private Limited | 22-10-2020 | 20201022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48708 | Not Recruiting | No | | | | 29-10-2020 | 258 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | Phase 2/ Phase 3 | India→ | Dr Manish Rajak→ | | B-7/1 Kothari Compound-27 Acres Nr Tiku-ji-ni wadi Resort Chitalsar Manapada→ | prasad@indusbiotech.com→ | 02026851239→ | Indus Biotech Private Limited→ | Inclusion criteria: 1. Subjects population will be healthcare personnel (physicians, nurses, laboratory staff, pharmacists, technicians, stretcher-bearer, ambulance driver, respiratory therapists, administrative staff) who work in healthcare facility or any other moderate to high-risk environment (public servants like policemen, municipal corporation workers) OR relative of a patient inclusive of those with direct/primary contact with positive COVID-19 infection <br/ ><br> <br/ ><br>2. Age 18-60 years <br/ ><br> <br/ ><br>3. Subject has not taken any prophylaxis medication for COVID-19 in last 30 days <br/ ><br> <br/ ><br>4.Subject agrees not to self-medicate with chloroquine, hydroxychloroquine, other potential antivirals or any other alternative medicines /supplements as a part of prevention of SARS-CoV-2 infection. <br/ ><br> <br/ ><br>5. Willing and able to provide written informed consent prior to performing study procedures <br/ ><br> <br/ ><br>6.Healthy at the time of enrolment without any symptoms suggestive of any viral infection <br/ ><br> <br/ ><br>7.Negative test for COVID-19 infection by RT-PCR using ICMR/WHO protocol <br/ ><br> <br/ ><br>8. Not previously diagnosed with COVID-19 <br/ ><br>9. Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use adequate contraceptive methods. <br/ ><br>→ | Exclusion criteria: 1. Subjects with a history of allergy or intolerance to Cinnamon <br/ ><br> <br/ ><br>2. Participation in any other clinical study for COVID-19 <br/ ><br> <br/ ><br>3. Laboratory confirmed COVID-19 with or without symptoms <br/ ><br> <br/ ><br>4. Pregnancy and Lactation mothers, and those who are planning for pregnancy <br/ ><br> <br/ ><br>5. Patients with serious, critical illness, or severe mental illness <br/ ><br> <br/ ><br>6. Any other condition, which the Principal Investigator thinks, may jeopardize the study. <br/ ><br>→ | | Intervention1: IND02 nasal spray: one shot, 100 micrograms of IND02/100 microliter in each nostril, thrice a day for 60 days<br>Control Intervention1: Placebo nasal spray: one shot, 0 microgram of IND02/100 microliter in each nostril, thrice a day for 60 days<br>→ | Proportion of COVID-19 infection free subjects on study completion in both the groupsTimepoint: Proportion of COVID-19 infection free subjects on study completion in both the groups→ | | | | Yes | False | | |
| → | CTRI/2020/10/028571 | 27 January 2021 | Treatment and followup outcomes of gynecological cancer patients treated with radiation therapy during lockdown phase of COVID pandemic | Outcomes of treatment and followup of patients treated with radiation therapy in
gynecological cancer during lockdown phase of COVID pandemic | | Tata Memorial Centre | 22-10-2020 | 20201022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47944 | Not Recruiting | No | | | | 30-10-2020 | 1500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Supriya Chopra→ | | Room no.L-05, Paymaster Shodhika,Sector 22, Utsav Chowk - CISF Road, Owe Camp, Kharghar, Navi Mumbai → | supriyasastri@gmail.com→ | 9930958309→ | Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)→ | Inclusion criteria: 1. Patients treated in Gynecology unit of radiation therapy in TMH, referred out, and/or followed up from 01.03.2020 to 31.07.2020 <br/ ><br>2. All age groups will be included in the study. <br/ ><br>→ | Exclusion criteria: None→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C51-C58- Malignant neoplasms of female genital organs
→ | | Audit of treatment characteristics of patients treated during COVID- 19 lockdown period.Timepoint: 01.03.2020 to 31.07.2020→ | | | | Yes | False | | |
| → | CTRI/2020/10/028569 | 27 January 2021 | Challenges for healthcare workers with infection control practices during COVID-19 pandemic | To survey healthcare workers
(HCW) on awareness and
challenges with the infection
prevention and control (IPC)
practices during COVID â?? 19
pandemic. | | None | 22-10-2020 | 20201022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47444 | Not Recruiting | No | | | | 26-10-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Anuradha Sharma→ | | C-128, Department of Microbiology, All India Institute of Medical Sciences Jodhpur → | asharma3170@gmail.com→ | 08003996896→ | All India Institute of Medical Sciences Jodhpur→ | Inclusion criteria: Healthcare workers→ | Exclusion criteria: Not willing to participate→ | | | IPC practices in relation to COVID-19 awareness among HCWsTimepoint: Collect data in one month→ | | 07/12/2020 | | Yes | False | | |
| → | CTRI/2020/10/028568 | 27 January 2021 | Evaluate Safety
and Efficacy of RV Forte Capsule as an immunomodulator in adult
Covid 19 positive patients | Phase II, open label, randomized controlled trial to evaluate Safety
and Efficacy of RV Forte Capsule as an immunomodulator in adult
Covid 19 positive patients - NIL | | RV New Vision Healthcare Pvt Ltd | 22-10-2020 | 20201022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45761 | Not Recruiting | No | | | | 26-10-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Gayatri Gnau→ | | 3 floor, room no. 3, Lokmanya Medical Research Centre & Lokmanya Hospital
Chinchwad
Pune → | vgvaidya178@gmail.com→ | | Lokmanya Medical Research Centre & Lokmanya Hospital→ | Inclusion criteria: Patients admitted with RT-PCR confirmed COVID-19 illness <br/ ><br>Age > 18 & < 65 years of either sex <br/ ><br>Mild to Moderately Covid 19 disease (NEWS score â?¤ 8) <br/ ><br>Signed informed consent must be obtained and documented according to AYUSH GCP, and <br/ ><br>national/local regulations.→ | Exclusion criteria: Pregnant women <br/ ><br>Breastfeeding women <br/ ><br>Requiring ICU admission at screening <br/ ><br>Patients above 65 years of age and below 18 Years <br/ ><br>Past History of MI, Epileptic episodes <br/ ><br>Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which <br/ ><br>is at critical stage at screening <br/ ><br>Any other condition by which subject proves unfit from investigator perspective <br/ ><br>Not giving consent.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: RV Forte Capsule along with standard treatment for 10 days: RV Forte 1 cap BD twice a day along with standard of care for 10 days<br>Control Intervention1: Standard treatment for 10 days: Standard treatment as per ICMR protocol for 10 days<br>→ | No. of days required for negative PCR confirmatory test <br/ ><br>Change in clinical symptom presentation <br/ ><br>Clinical status expressed in percentage of subjects reporting each severity rating <br/ ><br>Changes in X ray <br/ ><br>Changes in inflammatory mediators like CRP, LDH and ferritinTimepoint: 10 days or negative PCR test for Covid 19 whichever is earlier→ | | 14/12/2020 | | Yes | False | | |
| → | CTRI/2020/10/028566 | 27 January 2021 | Yoga for COVID-19 asymptomatic patients | EFFICACY OF INTEGRATED YOGA INTERVENTION ON PHYSIOLOGICAL AND PSYCHOLOGICAL OUTCOMES OF COVID-19 ASYMPTOMATIC PATIENTS | | Pragya Jain Shrimal | 22-10-2020 | 20201022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48585 | Not Recruiting | No | | | | 02-11-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Other Blinding and masking:Not Applicable | Phase 1 | India→ | Pragya Jain Shrimal→ | | Department of yoga and life science, Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Anekal, Jigani, Bangalore
→ | trisatyapriya77@gmail.com→ | 8618587448→ | Swami Vivekananda Anusadhan Samsthan (S-VYASA) Deemed to be University, Bangalore→ | Inclusion criteria: 1) Only COVID-19 positives confirmed by RT-PCR method to be recruited. <br/ ><br>2) Inclusion of COVID-19 asymptomatic patients as per WHO guidelines. <br/ ><br>3) Inclusive of people under Quarantine under Government setup. <br/ ><br>4) Inclusion of asymptomatic patients. <br/ ><br>→ | Exclusion criteria: 1) Unwilling for participation. <br/ ><br>2) Physical and mental disability. <br/ ><br>3) Medical restriction for physical movement. <br/ ><br>4) History of recent surgery. <br/ ><br>5) Pregnant females. <br/ ><br>6) Severe Comorbid conditions (uncontrolled Diabetes, Uncontrolled Hypertension and Cardiac diseases, COPD etc.).→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Yoga modules for management of coronavirus disease 2019: Integrated tele based yoga intervention will consist of Breathing practices, Pranayama and Meditation. Tele based yoga intervention will be given for a period of 7 days, 30 minutes/day in which 15 minutes in everyday it will be practice under the observation of medical staff and 15 minutes they will do self-practice in the evening with the help of Television in their respective wards.<br>Control Intervention1: Control Group Participants - Routine care activity: All participants in control group will follow Routine care activity .<br>→ | Oxygen Saturation, Heart Rate, Respiratory Rate and Blood pressureTimepoint: Day 1 and Day 7→ | | | | Yes | False | | |
| → | CTRI/2020/10/028537 | 27 January 2021 | Clinical trial of Ayurvedic Medicines in Patients with Asymptomatic and/or Mild Symptoms of COVID-19 | Evaluation of Immuno-Modulatory Potential of Ayurvedic Medicines in Patients with Mild Symptoms of COVID-19: Single Blinded, Randomized and Controlled Study - NIL | | Shree Baidyanath Ayurved Bhawan Pvt Ltd | 22-10-2020 | 20201022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48342 | Not Recruiting | No | | | | 22-10-2020 | 90 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Participant Blinded | Phase 2 | India→ | Dr Anurag Gupta→ | | B6/5 Local Shopping Center,
Near HDFC Bank,
Safdarjung Enclave, New Delhi,110029
Same as above→ | vaidya@baidyanath.co.in→ | 9971009222→ | Shree Baidyanath Ayurved Bhawan Pvt. Ltd.→ | Inclusion criteria: Age more than 18 or less than 75 years at time of signing Informed Consent Form. <br/ ><br>COVID positive by RTPCR <br/ ><br>Cases that have been assigned as mild or very mild or asymptomatic cases of COVID. <br/ ><br>Cases presenting with fever and/or upper respiratory tract illness (Influenza like illness, ILI). <br/ ><br>No difficulty in swallowing oral medications. <br/ ><br>Must agree not to enroll in another study of an investigational agent prior to completion of study. <br/ ><br>→ | Exclusion criteria: Allergies, known to be allergic to research drugs or drug excipients; <br/ ><br>Subject weight is less than 40 kg <br/ ><br>Pneumonia with/without signs of severe disease. <br/ ><br>COVID Cases with ARDS or Septic shock. <br/ ><br>Patients who have participated in other clinical trials within 1 month. <br/ ><br>Known patients with impaired renal function (estimated creatinine clearance <60 mL / min <br/ ><br>During the screening or within 24 hours before screening, patients were found to have any of the following laboratory parameter abnormalities (based on local laboratory reference range):-ALT or AST level 5 times the upper limit of normal range (ULN) or-ALT or AST more than 3 times ULN and total bilirubin levels more than 2 times ULN. <br/ ><br>Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Chyawanprash (Sugar Free) Along with Standard medicine as per ICMR protocol for 21 days and post treatment follow up till 28th day: Dose: 12-24 gm (1-2 teaspoons) morning and evening, Anupan: Milk, Water, Mode of administration: Oral (AFI Part I, 3:11). The dose shall be prepared and given to the randomly selected patients <br><br><br>Intervention2: Immuncoction Along with Standard medicine as per ICMR protocol for 21 days and post treatment follow up till 28th day : Dose: 30 - 40 ml, with warm water.<br>Duration/Frequency: Twice/Thrice a day<br>Time: ½ Hr. before or after meal<br><br><br>Control Intervention1: Standard Medicine: Standard medicine as per ICMR protocol and follow up on 28th day<br>→ | Serum levels of Immunological panel CD4, CD8, NK cell panel CD16/CD56 <br/ ><br>Serum CRP levels <br/ ><br>Inflammatory mediators like IL-6 and TNF alpha <br/ ><br>Change in clinical symptom presentation in Fever, Cough, breathlessness, fatigue and myalgia, loss of taste and smell on 5 point ordinal <br/ ><br>Timepoint: From Baseline to End of the Study <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/10/028570 | 27 January 2021 | To study the effect of Vyaghradi Kashay tablet on COVID-19 patients | An interventional, single arm study to observe and assess the effectiveness of â??Vyaghradi Kashaya Tabâ?? in preventing the progression of severity in asymptomatic, mild to moderate COVID-19 cases. | | Ministry of AYUSH Govt of India | 22-10-2020 | 20201022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48600 | Not Recruiting | No | | | | 05-11-2020 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Dr Nitin Jindal→ | | Department of Panchakarma
A and U Tibbia College and Hospital
Karol Bagh → | manoj_1873@yahoo.co.in→ | | A and U Tibbia College and Hospital Govt of NCT of Delhi→ | Inclusion criteria: People who have been tested positive to be infected with SARS-CoV2 virus and presenting with no symptoms or with mild to moderate symptoms. <br/ ><br>All the patients of age group 18-65 yrs <br/ ><br>All those who are willing to give written consent for participation in the study <br/ ><br>→ | Exclusion criteria: COVID patients with symptoms classified as severe or critical. <br/ ><br>Persons with severe primary respiratory disease or other pneumonia <br/ ><br>Pregnant and lactating women <br/ ><br>Persons with serious complications of diseases such as cancer, heart disease, stroke, disabilities, mental illnesses, etc., and who are considered to be excluded from the study as evaluated by the investigators <br/ ><br>COVID-19 positive cases participating as subjects in the interventional arm of other COVID-19 clinical trials. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Vyaghradi Kashay Tablet: Drug- Vyaghradi Kashay Tablet <br>Dose : One tab(500mg)three times a day with luke warm water<br>Route -Oral<br>Duration - 7 days (Initially). If RTPCR Not negative in 7 days it will continue up to 14 days<br>Control Intervention1: Not applicable: Not applicable<br>→ | Time taken to be tested negative for SARS-CoV2 in RT-PCR. <br/ ><br>To Assess the effect of drug in preventing the progression of severity of symptoms.Timepoint: a)RT PCR 7th and 14th Day <br/ ><br>b)Assessment of clinical recovery at baseline, Daily 7-14 days <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/10/028567 | 27 January 2021 | Red cell antibody profile in Covid-19 | A study of red cell antibody profile in patients of Covid-19 in a tertiary care center | | Seth GS Medical College and KEM Hospital | 22-10-2020 | 20201022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46310 | Not Recruiting | No | | | | 01-11-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Swarupa Nikhil Bhagwat→ | | Dept of Transfusion Medicine, Seth GS Medical College and KEM Hospital, Parel, Mumbai, maharashtra,40012 → | swarupabhagwat@kem.edu→ | 9969044986→ | Seth GS Medical College and KEM Hospital, Mumbai→ | Inclusion criteria: 1) Blood sample must be of covid-19 positive patient. This is mentioned on the requisition form and the RT PCR status will be doubly reconfirmed by calling up the ward. <br/ ><br>And <br/ ><br>2) At least one of the following: <br/ ><br>i) Sample showing blood group discrepancy (Extra serum reactivity) causing difficulty in interpretation of blood groups <br/ ><br>ii) Sample showing incompatible crossmatch with at least one donor unit in saline and /or antiglobulin phase <br/ ><br>iii) Sample showing positive direct and /or indirect antiglobulin test (any of the grades weak ,1+, 2+, 3+ ,4+) <br/ ><br> <br/ ><br>Blood grouping discrepancy is defined as the situation when the results of forward and reverse blood group do not match , thus giving rise to difficulty in the interpretation of blood group. <br/ ><br>→ | Exclusion criteria: 1) Sample that was found hemolysed after completion of all the prescribed tests on the sample. This will be assessed by visual inspection as per the existing SOP <br/ ><br>2) Inadequate left over sample ( less than 1ml) <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | There is no intervention in the study. <br/ ><br>The expected results: samples are likely to show positive Direct antiglobulin test and presence of cold antibodiesTimepoint: At day 0: Antiglobulin test results and red cell antibody screening will be performed. They are expected to show positive results <br/ ><br> <br/ ><br>At day 4: Type of antibody (warm or cold) and identification of antibody will be performed on the same sample. <br/ ><br> <br/ ><br>At 2 months: Patients clinical profile will be assessed and will be correlated with antibody profile. <br/ ><br> <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/10/028539 | 27 January 2021 | High-flow nasal cannula oxygen in adult patients of COVID-19 admitted to intensive care units. | A retrospective study on experience of high-flow nasal cannula oxygen in adult patients of COVID-19 admitted to intensive care unitsâ??. | | Maulana Azad Medical College and associated Lok Nayak Hospital | 22-10-2020 | 20201022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48627 | Not Recruiting | No | | | | 28-10-2020 | 70 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | sukhyanti kerai→ | | Department of Anaesthesiology & Intensive Care, Room no 413, B.L. Taneja block, Maulana Azad Medical College, New Delhi → | drsukhi25@gmail.com→ | 09968527122→ | Maulana Azad Medical College→ | Inclusion criteria: COVID-19 adult patients (â?¥ 18 years old) with an estimated Pao2/Fio2 of less than 300 or those with failure to maintain SpO2 of â?¥90% with conventional oxygen delivery devices, who received HFNC for respiratory support between April 2020 to September 2020.→ | Exclusion criteria: The patients younger than 18 years of age, those with hypercapneic respiratory failure (pH 45 mmHg),→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | outcome of HFNC treatmentTimepoint: outcome of HFNC treatment during ICU stay at baseline→ | | | | Yes | False | | |
| → | CTRI/2020/10/028597 | 27 January 2021 | Low dose lung X-ray therapy for COVID-19 | Whole lung Irradiation as a Novel treatment for COVID-19 - WIN COVID-19 | | Harshamitra Superspecialty Cancer Centre and Research Institute | 23-10-2020 | 20201023 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48730 | Not Recruiting | No | | | | 06-11-2020 | 61 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 2 | India→ | Vivek Sundaram→ | | No.17, Room no.2, Ground floor, Department of internal medicine, COVID block, E.V.R. Road, Puthur, Trichy, Tamilnadu -
620017
→ | drsasipriyahmitra@gmail.com→ | 7373642777→ | Harshamitra Oncology Private Limited→ | Inclusion criteria: 1. Adult patients with RT-PCR proven COVID-19 with moderate to severe pneumonia with fewer than 14 days of symptom onset that warranted hospitalization and currently receiving standard medication for COVID-19 at appropriate doses which would include, among others, antivirals, corticosteroids, or anti-IL-6 tocilizumab. <br/ ><br>and <br/ ><br>2. moderate to severe dyspnoea, respiratory frequency equal to or greater than 30/min, oxygen saturation without supplemental O2 supply SpO2 94% or less, PaO2/FiO2 ratio or PaFiO2 ratio between 200 to 300 or SpO2/FiO2 ratio 315 or less if PaO2 is not available <br/ ><br>and/or <br/ ><br>3. laboratory abnormalities such as C-reactive protein >100 mg/L or D-dimer >1000 ng/ml or IL-6 >50 IU or suspected cytokine release syndrome <br/ ><br> <br/ ><br>(Criteria 1 and 2 are mandatory and 3 is optional)→ | Exclusion criteria: 1. Patients on ventilators (invasive/non-invasive) <br/ ><br>2. Prior lobectomy or pneumonectomy <br/ ><br>3. Prior thoracic radiotherapy resulting in a maximum lung dose of 100 cGy or higher within 14 days of enrollment <br/ ><br>4. Prior chemotherapy or other systemic therapy with potential for pulmonary toxicity or radio sensitization within 14 days or 5 half-lives, whichever is greater, of enrollment, e.g., bleomycin, gemcitabine <br/ ><br>5. Prior cancer immunotherapy with an immune checkpoint inhibitor within 60 days of enrollment <br/ ><br>6. Severe pre-existing heart disease, e.g., New York Heart Association (NYHA) functional class 3 (or higher) congestive heart failure <br/ ><br>7. History of bone marrow or solid organ transplantation <br/ ><br>8. Known history of autoimmune collagen vascular disease, e.g., scleroderma <br/ ><br>9. Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia <br/ ><br>10. Pregnancy <br/ ><br>11. Inability to be positioned supine and flat for radiation planning and delivery <br/ ><br>12. Inability to provide informed consent or lack of an authorized representative who can provide informed consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Low Dose Radiation therapy in addition to standard pharmacological therapy: Low dose radiotherapy using a Linear accelerator to bilateral whole lungs as a single fraction treatment with a dose of 0.5 Gy in addition to pharmacological therapy based on guidelines devised by Ministry of Health and Family welfare, India<br>Dexamethasone 6mg IV Once daily for 10 days, (Alternative: Methylprednisolone 80mg IV BD for 10 days)<br>Enoxiparin 60mg s/c Once Daily for 5 days (dose adjusted based on D-dimer levels), <br>Remdesvir 200mg IV Once daily on day 1 followed by 100mg IV Once daily for next 4 days, further continuance based on clinical response, <br>Convalescent plasma One or two units (approximately 200-250ml per unit), <br>Tocilizumab 400mg IV as a single dose (repeat dose in 12 to 24 hours if patientâ??s condition has not<br>improved), Vitamin D 60,000U /week, <br>Vitamin C 1500 mg/day,<br>Zinc,<br>Paracetamol, Anti-tussives, Antibiotics,<br>Oxygen supplementation. <br>Adjunctive therapies : IV thiamine,IV vitamin C, N acetyl cysteine, Ulinastatin, Sepsivac (mycobacterium w), high dose statins. <br>Salvage therapies : Pulse therapy of steroids, Cytosorb-hemoperfusion, Pirfenidone,Alteplase.<br>The pharmacologic therapy is individualized on a case by case basis.<br>Control Intervention1: Standard Pharmacological Therapy only: Pharmacological therapy based on guidelines devised by Ministry of Health and Family welfare, India.<br>Dexamethasone 6mg IV Once daily for 10 days (Alternative: Methylprednisolone 80mg IV BD for 10 days), Enoxiparin 60mg s/c Once Daily for 5 days (dose adjusted based on D-dimer levels), Remdesvir 200mg IV Once daily on day 1 followed by 100mg IV Once daily for next 4 days, further continuance based on clinical response, Convalescent plasma One or two units (approximately 200-→ | The primary end-point will be to evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PaO2-FiO2 by 20% measured 48-72h after treatment with respect to baseline pre-irradiation measurementTimepoint: 6 hours,day 1, day 2, day 3, day 4, day 7→ | | | | Yes | False | | |
| → | CTRI/2020/10/028598 | 27 January 2021 | Assessment of SARS CoV-2 seroprevalence and clinical profiling of COVID Unsuspected patients attending Otorhinolaryngology Department at AIIMS Jodhpur. | Clinical profiling and assessment of SARS CoV 2 seroprevalence in clinically unsuspected patients attending Otorhinolaryngology Department | | All India Institute of Medical Sciences Jodhpur | 23-10-2020 | 20201023 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47989 | Not Recruiting | No | | | | 02-11-2020 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Nitika Goyal→ | | Department of Otorhinolaryngology,AIIMS Jodhpur → | meetugoyal@yahoo.com→ | 8003996881→ | AIIMS Jodhpur→ | Inclusion criteria: Patients presented to Otorhinolaryngology Department who have been screened for COVID-19 using ICMR screening criteria and labelled negative.→ | Exclusion criteria: Patient already diagnosed as COVID 19 positive through RT PCR <br/ ><br>Patients who were quarantined/isolated in past for COVID-19 <br/ ><br>Patients with immunocompromised state <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Seroprevalence detection using IgM/IgG antibody testingTimepoint: 1 year→ | | | | Yes | False | | |
| → | CTRI/2020/10/028602 | 27 January 2021 | Phase II Study of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients | A Multicentre, Phase 2, Randomised Study to Assess the Efficacy and Safety of Bemcentinib for the Treatment of COVID-19 in Hospitalised Patients | | BerGenBio ASA | 23-10-2020 | 20201023 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48797 | Not Recruiting | No | | | | 03-11-2020 | 120 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | Phase 2 | India;South Africa→ | Suneela Thatte→ | | IQVIA RDS (India) Private Limited Natraj by Rustomjee 6th Floor 194 MV Road Near Western Express Highway Metro Station Andheri East Mumbai 400 069 Mumbai
Mumbai
MAHARASHTRA
400 069
India → | suneela.thatte@iqvia.com→ | 912266774242→ | IQVIA RDS (India) Private Limited→ | Inclusion criteria: 1.Adults (â?¥18 years) with SARS-CoV-2 infection confirmed by laboratory tests and/or point of care tests (which may include results from a test that was performed prior to hospital admission if, in the opinion of theInvestigator, it is relevant to ongoing COVID 19). <br/ ><br>2.Patients with symptoms and/or signs consistent with COVID-19, requiring treatment. <br/ ><br>3.A score of Grade 3 to 5 on the 9-point ordinal scale.In India; only patients with a score of Grade 4 or 5 will be enrolled. <br/ ><br>4. a) Male patients: <br/ ><br>â?¢A male patient must agree to use contraception as detailed in Appendix 5 during the treatment period and for at least 120 days after the last dose of study treatment and refrain from donating sperm during this period. <br/ ><br>b) Female patients: <br/ ><br>â?¢A female patient is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions applies: <br/ ><br>i Not a woman of childbearing potential <br/ ><br>OR <br/ ><br>iiA woman of childbearing potential who agrees to follow the contraceptive guidance in Appendix 5 during the treatment period and for at least 120 days after the last dose of study treatment. <br/ ><br>5.Women who are lactating who agree not to breastfeed their child during the study and for at least 120 days after termination of study therapy (they may continue to express milk away from the child during this period, but this milk must be discarded). <br/ ><br>6.Ability to provide informed consent signed by the study patient or legally authorised representative. <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1.Patients who have previously had a score of 6 or 7 on the 9-point ordinal scale. <br/ ><br>2.Inability to swallow capsules (administration via nasogastric tube is permitted in patients who become unable to swallow after starting the study drug) <br/ ><br>3.History of the following cardiac conditions: <br/ ><br>a)Myocardial infarction within 3 months prior to the first dose <br/ ><br>b)Unstable angina <br/ ><br>c)History of clinically significant dysrhythmias (long QT features on ECG, sustained bradycardia [â?¤55 bpm]), left bundle branch block, or ventricular arrhythmia) or history of familial long QT.Patients with an implantable cardioverter defibrillator device in place, will be allowed to enrol. Atrial fibrillation will not be a reason for exclusion. <br/ ><br>4.Screening 12-lead ECG with a measurable QT interval according to Fridericia correction (QTcF) >470 msec. In the presence of a cardiac pacemaker, QTcF will need to be calculated from an ECG which has been recorded during a period where ventricular (QRS) complexes without pacing are present. If no unpaced ventricular complexes are present to allow calculation of QTcF, the patient should not be enrolled in this protocol <br/ ><br>5.Clinically significant hypokalaemia: Individuals who do not meet this criterion may be rescreened once, after correction of 6.Therapeutic anticoagulation with vitamin K antagonists. Note: Patients receiving low doses prescribed to maintain the patency of venous access devices may be included. <br/ ><br>7.Previous bowel resection that would interfere with drug absorption. <br/ ><br>8.Any patient whose interests are not best served by study participation, as determined by a senior attending clinician. <br/ ><br>9.Alanine aminotransferase/aspartate aminotransferase >5 Ã? the upper limit of normal electrolyte abnormality. <br/ ><br>10.Current treatment (or planned initiation of treatment during the first 15 days of the study) for human immunodeficiency virus (HIV) or tuberculosis (TB). <br/ ><br>11.Positive serologic assay at screening for hepatitis B virus (Hep B surface antigen) or hepatitis C virus (hepatitis C PCR or hepatitis C core antigen) at local laboratory. <br/ ><br>12.Stage 4 severe chronic kidney disease. <br/ ><br>13.Anticipated transfer to another hospital that is not a study centre within 72 hours. <br/ ><br>14.Allergy to any study treatment. <br/ ><br>15.Experimental off-label usage of medicinal products as treatments for COVID-19 (except where the product has either been given a positive opinion under the Early Access to Medicines Scheme [EAMS] or is a SARS-CoV-2 vaccine) at the time of enrolment. <br/ ><br>16.Patients participating in another clinical study of an investigational medicinal product. <br/ ><br>17.Current or planned treatment for tuberculosis. <br/ ><br>→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Bemcentinib (BGB324) 100mg Oral: 1)400mg of will be given on Day 1 through Day 3 <br>2)200mg of will be given on Day 4 through Day 15<br><br>Control Intervention1: Study Drug: Bemcentinib (BGB324) 100mg Oral: â?¢400mg of will be given on Day 1 through Day 3 <br>â?¢200mg of will be given on Day 4 through Day 15<br><br>Control Intervention2: Not Applicable: Not Applicable<br>→ | To evaluate the efficacy of bemcentinib as add-on therapy to standard of care (SoC) in patients hospitalised with coronavirus disease 2019 (COVID-19)Timepoint: Time to sustained clinical improvement of at least 2 points (from randomisation) on a 9-point category ordinal scale, live discharge from the hospital, or considered fit for discharge (a score of 0, 1, or 2 on the ordinal scale), whichever comes first, by Day 29 (this will also define the â??responderâ?? for the response rate analyses).→ | | | | Yes | False | | |
| → | CTRI/2020/10/028600 | 27 January 2021 | Knowledge Attitude and Practice of Hand hygiene among Nursing Assistants and Trolley workers in a COVID-19 care units | Knowledge Attitude and Practice (KAP) of Hand hygiene among Nursing Assistants and Trolley workers in a Corona Virus Disease 2019 (COVID-19) care units at a Tertiary care Hospital in North Kerala | | Govt Medical College Kannur | 23-10-2020 | 20201023 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46239 | Not Recruiting | No | | | | 05-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Venugopalan A K→ | | Dept of Community Medicine
Govt Medical College Kannur
Po Pariyaram Medical College
Dist Kannur Kerala State
670503
Govt Medical College Kannur
Po Pariyaram Medical College
Dist Kannur
Kerala 670503→ | kalarivenu@gmail.com→ | 9446168325→ | Govt Medical college Kannur→ | Inclusion criteria: All Nursing Assistants and Trolley workers working at Govt Medical College Kannur who are willing to participate in the study→ | Exclusion criteria: Not willing to participate→ | | | To assess the Knowledge attitude and practice of hand hygiene among Nursing Assistants and Trolley workersTimepoint: 1 (baseline)→ | | | | Yes | False | | |
| → | CTRI/2020/10/028581 | 27 January 2021 | Clinical trial to study the effect of Budesonide taken through inhalation in mild COVID cases | Inhalation Budesonide in the treatment of patients with mild Covid-19 | | Dr Tushar Patel | 23-10-2020 | 20201023 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47042 | Not Recruiting | No | | | | 23-10-2020 | 1000 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Tushar Patel→ | | SPARSH Chest Disease Centre, 100B Swastik Society, Opposite Samved Hospital, Navrangpura, Ahmedabad Respiratory Medicine Department, GCS Hospital, Near Chamunda Bridge, Naroda road, Ahmedabad 380025→ | drtusharpatel@yahoo.com→ | 985082672→ | GCS Medical College, Ahmedabad→ | Inclusion criteria: 1.Patient with RT-PCR OR Rapid Antigen confirmed diagnosis of Covid-19. <br/ ><br>asymptomatic Patent with mild symptoms of less than 5 days duration. <br/ ><br>3.Spo2 >94% at room air. <br/ ><br>4.No Radiological evidence of Pneumonia. <br/ ><br>5 Patient aged >18years to 99Years.→ | Exclusion criteria: 1. Patient requiring hospitaisation. <br/ ><br>2. Patient unable to take the drug as drirected and comply with study procedure. <br/ ><br>3.Vulnerable population(Pregnant women,Lactating women,Prisoners,Unable to consent). <br/ ><br>4 Patients on Systemic/Inhalational Steroids.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Budesonide, Local standard of care: Budesonide Rotacaps 200 mcg BD for 10 - 14 days depending on onset of symptoms given in addition to the local standard of care<br>Intervention2: BUDESONIDE ROTACAP DRY POWDER INHELAR: BUDESONDE ROTACAP DPI TAKEN TROUGH ROTAHELAR TWICE DAY<br>Control Intervention1: Local standard of care: Local standard of care for mild COVID-19 cases as provided by the centre<br>→ | HospitalizationTimepoint: 10 - 14 days depending on the onset of symptoms→ | | | | Yes | False | | |
| → | CTRI/2020/10/028580 | 27 January 2021 | Effectiveness of an online training module with lectures and videos regarding maternal and newborn care during COVID 19 pandemic on the knowledge and acceptability among nursing students | A study to assess the effect of an integrated E - educational package on maternal and neonatal care during Covid 19 pandemic on knowledge and acceptability among nursing students at college of Nursing, AIIMS, New Delhi. | | NIL | 23-10-2020 | 20201023 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48581 | Not Recruiting | No | | | | 26-10-2020 | 50 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Levis Murry→ | | F 16, Ansari Nagar west College of Nursing AIIMS, New Delhi→ | levis.murry@gmail.com→ | 7838990810→ | AIIMS→ | Inclusion criteria: All first year post-basic BSc nursing students <br/ ><br>1. Available at the time of study. <br/ ><br>2. Willing to participate in the study. <br/ ><br>→ | Exclusion criteria: NIL→ | | Intervention1: E - Educational Package: An online package consisting of e - learning modules on neonatal resuscitation, maternal and newborn care during Covid pandemic. The package will include webinars embedded with videos scheduled for an hour everyday for 14 days which can be accessed by students.<br>Control Intervention1: NIL: NIL<br>→ | 1. To develop an integrated e-educational learning package on package on maternal and neonatal care during COVID-19 pandemic <br/ ><br>2. To assess the effect of an integrated e- learning package on package on maternal and neonatal care during Covid 19 pandemic on knowledge of students.Timepoint: Zero and two weeks→ | | | | Yes | False | | |
| → | CTRI/2020/10/028637 | 27 January 2021 | Best Larnyngoscopes for tracheal intubation in covid patient with intubation box | Comparison Between C-MAC and King Vision Video laryngoscope (Channeled blade) for Tracheal intubation in Manikin with Aerosol Prevention Intubation Box For COVID-19 patients. | | AIIMS new Delhi | 26-10-2020 | 20201026 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44357 | Not Recruiting | No | | | | 04-11-2020 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Outcome Assessor Blinded | Phase 3/ Phase 4 | India→ | Dr Balbir Kumar→ | | Building no-17, flat -D1, Anupum enclave saidulajab Saket 110030 → | drbalbir10@gmail.com→ | 7006582855→ | AIIMS New Delhi→ | Inclusion criteria: Senio and junior doctors <br/ ><br>should have done at least 20 normal intubation with both devices <br/ ><br>ready to give consent→ | Exclusion criteria: unable to perform intubation <br/ ><br>not given consent <br/ ><br>→ | | Intervention1: CMAC VIDEO LARYNGOSCOPE: Intubate the trachea of manikin with help of CMAC video laryngoscope under intubation box.<br>Control Intervention1: King vision Vediolaryngoscope(Channelled blad): Vedio laryngoscope different from CMAC in the way that it help in negotiating the endotracheal intubation without help of stylet.Tracheal intubation of manikin will be done under intubation box by creating condition of COVID-19 patient<br>→ | comparison of time taken for successful intubation using CMACvs King vision laryngoscopeTimepoint: immediately pre and post intubation.→ | | | | Yes | False | | |
| → | CTRI/2020/10/028635 | 27 January 2021 | use of VIRUNIL an Ayurvedic medicie as a supportive treatment in management of COVID-19. | Clinical evaluation of Virunil a standardized ayurvedic herbal compound as an adjuvant in management of COVID-19 | | NRI ACADEMY OF SCIENCES | 26-10-2020 | 20201026 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48783 | Not Recruiting | No | | | | 02-11-2020 | 150 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Alternation Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr V Siva Prabodh→ | | VICE PRINCIPAL ACADEMIC SECTION , ROOM NO-3.
NRI Medical College & GH,
CHINNA KAKANI, GUNTUR DISTRICT. → | srivatsa.sivakrishna@gmail.com→ | 7075096010→ | N R I MEDICAL COLLEGE AND GENERAL HOSPITAL→ | Inclusion criteria: Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures. <br/ ><br>Patient who are present in the stages of 1 and 2 of the COVID-19 disease.→ | Exclusion criteria: 1. Patients with Auto Immune Disorders. <br/ ><br>2. Patients with Co morbid conditions such as Diabetes Mellitus and Hypertension. <br/ ><br>3. Patients Under any kind of Anti-Cancer medication, Immunosuppressants. <br/ ><br>4. Patients who are under anti-platelet medication. <br/ ><br>5. Patients with history of Organ Transplantation. <br/ ><br>6. Patients with compromised pulmonary function. <br/ ><br>7. Patients receiving antiviral drugs. <br/ ><br>8. Pregnant and lactating mothers are also excluded from the study. <br/ ><br>9. Any other condition, where investigators jeopardize the outcomes of the trials <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J99- Respiratory disorders in diseasesclassified elsewhere
→ | Intervention1: Virunil 500mg Capsules: 1500mg per day in divided doses (3doses per day) with water.<br>for up to maximum of 10 days. Mode of Administration: Oral<br><br>Control Intervention1: Standard Supportive Care: These patients will be managed by standard supportive care.<br>→ | The drug may reduce the hospital stay & inflammatory condition of COVID19 patientsTimepoint: At base line, 7th day and 10th day→ | | | | Yes | False | | |
| → | CTRI/2020/10/028634 | 27 January 2021 | Impact of high flow oxygen therapy on outcomes of COVID-19 patients | High Flow Nasal Oxygen Therapy in COVID-19 critically ill patients with acute hypoxemic respiratory failure: An observational study | | Rajendra Institute of Medical Sciences | 26-10-2020 | 20201026 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48823 | Not Recruiting | No | | | | 02-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Mohd Saif Khan→ | | Room Number 505 New Trauma Centre RIMS, Bariatu
Bariatu
→ | drsaif2k2@gmail.com→ | 8870561682→ | Rajendra Institute of Medical Sciences→ | Inclusion criteria: Confirm COVID- 19 positive patients. <br/ ><br>Acute Hypoxemic respiratory failure (P/F ratio <300) or O2 saturation <90% with respiratory rate >25 breaths per minute with respiratory distress <br/ ><br> <br/ ><br>→ | Exclusion criteria: Intubation prior to HFNOT <br/ ><br>Shock (MAP <65 mm of Hg, SBP <90 mm of Hg) <br/ ><br>Requirement of vasopressor infusion <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Change in PaO2/FiO2 ratioTimepoint: at 1 hour, 6 hour, 7 days and 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/10/028639 | 27 January 2021 | Trends of Symptoms in Patients Under Institutional Isolation in COVID-19 Pandemic in India-An Observational studyâ??
| Trends of Symptoms in Patients Under Institutional Isolation in COVID-19 Pandemic in India-An Observational study
| | intramural funding from AIIMS new delhi | 26-10-2020 | 20201026 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44503 | Not Recruiting | No | | | | 26-10-2020 | 1000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 4 | India→ | Dr Balbir Kumar→ | | Room no 19,First Floor Academic Block
NCI Jhajjar,AIIMS New Delhi → | drbalbir10@gmail.com→ | 7006582855→ | AIIMS New delhi→ | Inclusion criteria: 1) Positive cases of COVID-19 admitted in NCI, isolation facility <br/ ><br>2) Patients who give informed consent <br/ ><br>→ | Exclusion criteria: Patients who do not understand Hindi or English. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | evaluate the symptoms trends of symptoms in COVID-19 patients in India.Timepoint: 3months→ | | | | Yes | False | | |
| → | CTRI/2020/10/028636 | 27 January 2021 | Covid 19 infection during pregnancy and its effect on the mother and baby | Obstetrical and Perinatal Outcome of pregnancies in suspected and confirmed cases of Covid-19 | | Christian medical College and hospital | 26-10-2020 | 20201026 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48380 | Not Recruiting | No | | | | 01-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Kavita Mandrelle→ | | Department of Obstetrics and Gynaecology Christian Medical College and Hospital→ | kavitamandrelle@gmail.com→ | 09646669700→ | Christian Medical College and Hospital→ | Inclusion criteria: All pregnant women with suspected or covid 19 infection→ | Exclusion criteria: Patient not consenting to participate in the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Obstetrical outcome during pregnancyTimepoint: from admission to discharge→ | | | | Yes | False | | |
| → | CTRI/2020/10/028648 | 27 January 2021 | To assess the overall effect of COVID-19 on intent of treatment and staging of cancer | A comparative analysis between annual audits to study the impact of COVID 19 on cancer diagnosis, stage of presentation and intent of treatment. | | Dr Aditi Chaturvedi | 27-10-2020 | 20201027 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46401 | Not Recruiting | No | | | | 02-11-2020 | 350 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Aditi Chaturvedi→ | | Service Floor,Oncology Department,East Block,Max Super Speciality Hospital(A Unit of Devki Devi Foundation),2,Press Enclave Road,Saket,New Delhi → | aditi.chaturvedi28@gmail.com→ | 9869845680→ | Max Super Speciality Hospital,A Unit of Devki Devi Foundation→ | Inclusion criteria: All patients should have undergone staging procedures using established clinical radiological or surgical methods <br/ ><br> <br/ ><br>All patients newly registered at the participating centre between 1.1.2019 to 31.12.2020 with a confirmed histopathological diagnosis of any malignancy <br/ ><br>→ | Exclusion criteria: Patients who are registered before 1.1.2019 with a confirmed histopathological diagnosis of any malignancy. <br/ ><br>Patients registered at different centres. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To study the impact of the COVID 19 pandemic on the number of solid cancer patients presenting at a tertiary centre, the stage of presentation and the intent of treatment <br/ ><br>Timepoint: 12 months→ | | | | Yes | False | | |
| → | CTRI/2020/10/028649 | 27 January 2021 | Surgery complications rates in pre and post COVID era | Comparative analysis of perioperative morbidity at a tertiary cancer care center in the pre and post COVID era â?? has the tide changed? | | Not applicable | 27-10-2020 | 20201027 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48029 | Not Recruiting | No | | | | 31-10-2020 | 888 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Deep Kumar Jain→ | | Homi Bhabha Cancer Hospital
Dept of Surgical Oncology
Ghanti Mill Road, Lahartara
Old Loco Colony,Shivpurwa
Varanasi (U.P) → | deepjain12@gmail.com→ | 7204438439→ | Homi Bhabha Cancer Hospital and Mahamana Pandit Madan Mohan Malviya Cancer Centre, Varanasi→ | Inclusion criteria: All patient that underwent any surgical intervention under regional or general anaesthesia during the period from 1st January to 30th July 2020. <br/ ><br>→ | Exclusion criteria: Patients that underwent surgical procedures with palliative intent. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C50-C50- Malignant neoplasms of breast
Health Condition 3: C15-C26- Malignant neoplasms of digestive organs
Health Condition 4: C51-C58- Malignant neoplasms of female genital organs
Health Condition 5: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
Health Condition 6: C60-C63- Malignant neoplasms of male genital organs
Health Condition 7: C45-C49- Malignant neoplasms of mesothelial and soft tissue
Health Condition 8: C30-C39- Malignant neoplasms of respiratory and intrathoracic organs
Health Condition 9: C64-C68- Malignant neoplasms of urinary tract
→ | | Peri-operative Morbidity based on Clavien dindo gradesTimepoint: Within 30days from date of surgery→ | | | | Yes | False | | |
| → | CTRI/2020/10/028657 | 27 January 2021 | Remdesivir effect in the treatment of corona | Effect of Remdesivir in the treatment of Covid-19 patients- An Observational Retrospective study | | Department of pharmacology | 27-10-2020 | 20201027 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47817 | Not Recruiting | No | | | | 30-10-2020 | 275 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Mitul Upadhyay→ | | Department of pharmacology, Government medical college bhavnagar, behind ST bus stand, Bhavnagar 364001. → | drmitulupadhyay@gmail.com→ | 9409386446→ | Government medical college Bhavnagar→ | Inclusion criteria: Covid rapid test positive or Rt-PCR test positive <br/ ><br> <br/ ><br>SpO2 level less than 94% or Xray suggestive of pneumonia. <br/ ><br>→ | Exclusion criteria: Patients file with incomplete details→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: Group A: Patients who have received remdesivir in addition to standard treatment<br>Group B:Patients who have received only standard care( No remdesivir): Group A: Remdesivir + Standard treatment<br>Group B: Only Standard treatment<br>→ | Reduction in SpO2 level and severity score <br/ ><br>Reduction in hospital stay and ICU stay <br/ ><br>Reduction in mortality <br/ ><br>Safety profile of remdesivirTimepoint: Reduction in SpO2 level and severity score at day 1,3,5,7,10,14,21,28 <br/ ><br>Reduction in hospital stay and ICU stay at day 28 <br/ ><br>Reduction in mortality at final outcome(death or discharge of patient) <br/ ><br>Safety profile of remdesivir (till discharge or death of patients)→ | | | | Yes | False | | |
| → | CTRI/2020/10/028672 | 27 January 2021 | A survey to know effect of Corona pandemic on medical postgraduate studentâ??s mental stress and their attitude to choose anaesthesiology as a career. | Effect of COVID 19 on postgraduate residentâ??s stress level and their attitude toward anaesthesiology as a career option in India: A Cross Sectional Study | | All India Institute of Medical Sciences Rishikesh | 27-10-2020 | 20201027 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48895 | Not Recruiting | No | | | | 30-11-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ashutosh Kaushal→ | | Department of Anaesthesiology,AIIMS,RISHIKESH AIIMS, rishikesh→ | drashutosh.kaushal@gmail.com→ | 09599156154→ | AIIMS Rishikesh→ | Inclusion criteria: 1. Post graduate residents of Anaesthesiology (1st ,2nd and 3rd year) of different medical institutes of India. <br/ ><br>2. Senior Residents (1st ,2nd and 3rd year) of Anaesthesiology of different medical institutes of India. <br/ ><br>→ | Exclusion criteria: 1. The participation is purely voluntary basis, any student unwilling to participate in the study will be excluded. <br/ ><br>2. Questionnaires which are returned incomplete will be excluded from the study. <br/ ><br>→ | | | Conduct survey to know the effect of COVID 19 on postgraduate residentâ??s stress level and their attitude toward anaesthesiology as a career option.Timepoint: It is Survey.→ | | | | Yes | False | | |
| → | CTRI/2020/10/028696 | 27 January 2021 | online survey among anaesthesiologists about method of assessing breathing tube before administering anaesthesia duirng Covid 19 pandemic | â??Practice of Pre operative airway assessment by anaesthesiologists in patients for
elective procedures during COVID-19 pandemicâ?? -a prospective cross sectional web based survey - SAFE PAC Survey | | DrGirijanandan D Menon | 28-10-2020 | 20201028 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48669 | Not Recruiting | No | | | | 29-10-2020 | 392 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrGirijananadan D Menon→ | | Department of Anaesthesiology,
Malankara Orthodox Syrian Church Medical College,
Kolenchery, Kochi, Ernakulam district, Kerala, India → | drdgmenon@gmail.com→ | 9447610900→ | Malankara Orthodox Syrian Church Medical College→ | Inclusion criteria: Anaesthesiologists who can understand questionnaire survey in English language→ | Exclusion criteria: → | | | Compare practice of airway examination by anaesthesiologists in the pandemic period with pre pandemic period and thereby assess if safety of the doctor/ patient is compromised <br/ ><br>Timepoint: Pandemic period and pre pandemic period <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/10/028688 | 27 January 2021 | A clinical trial of NanoAgCide hand sanitizer on Coronavirus patients. | A prospective open label clinical trial to evaluate the topical viral load reduction potential of Colloidal
Silver (NanoAgCideTM) based hand sanitizer on SARS-CoV-2 infected subjects.
| | WeInnovate Biosolutions Pvt Ltd | 28-10-2020 | 20201028 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48254 | Recruiting | No | | | | 31-10-2020 | 20 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Subham Dutta→ | | 2nd Main Road, Building #06, 3rd Floor.
Arekere, Sarvobhogam Nagar.
Bangalore . KA INDIA → | wibcto@gmail.com→ | 9890999625→ | WeInnovate Biosolutions Pvt. Ltd→ | Inclusion criteria: 1. Male or Female aged 18 to 80 years (both inclusive) of age tested SARS-CoV-2 positive within last <br/ ><br>8 days of study enrolment. <br/ ><br>2. Patients willing to sign written informed consent and are ready to comply to study procedure. <br/ ><br>3. SARS-CoV-2 positive asymptomatic or symptomatic patients who are under institutional <br/ ><br>quarantine. <br/ ><br>→ | Exclusion criteria: 1. Patients requiring emergency treatment during enrolment. <br/ ><br>2. Patients on ventilator support. <br/ ><br>3. Pregnant or lactating woman. <br/ ><br>4. Subjects with history of sun burn on hands. <br/ ><br>5. Subjects with history of skin disorders or on medication for the same: Eczema, Urticaria, Psoriasis, <br/ ><br>Herpes, skin cancer, Lupus, Vitiligo, Fungal infection, Candidiasis. <br/ ><br>6. Subjects on treatment of any degree burns. <br/ ><br>7. Any kind of psychiatric disorder or a condition in the opinion of the investigator may hinder <br/ ><br>communication with the research team. <br/ ><br>8. Inability of the subject to cooperate or communicate with the research team. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Colloidal Silver (NanoAgCideTM): Active Ingredient: Colloidal Silver (B.P.) 50 ppm <br>12 sprays on each hand -wait for 60 sec, rub hands for 30 seconds,<br>Control Intervention1: NA: NA<br>→ | Clinically significant Quantitative Reduction of 80% Virus load from baseline to EOT. <br/ ><br>Timepoint: 90 secs <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/10/028695 | 27 January 2021 | Can Vitamin C reduces COVID-19 symptoms | Role of Oral Vitamin C in Reducing the Duration and Severity of symptoms in COVID-19 Positive Patients: Prospective Randomized Controlled Trial | | Nil | 28-10-2020 | 20201028 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43749 | Not Recruiting | No | | | | 05-11-2020 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 4 | India→ | DR BALBIR KUMAR→ | | Room no 19,First floor,Academic block NCI,Jhajjar
AIIMS New Delhi NCI Jhajjar,AIIMS New Delhi→ | drbalbir10@gmail.com→ | 7087432124→ | AIIMS New Delhi→ | Inclusion criteria: Age more than 18years , <br/ ><br>COVID-19 positive(RT-PCR) <br/ ><br>either sex <br/ ><br>Symptomatic patient(fever, cough and breathing difficulty)→ | Exclusion criteria: 1. History of allergy to vitamin C <br/ ><br>2. Pregnant females or breastfeeding mothers <br/ ><br>3. Critical ill patient who are intubation and on mechanical ventilation <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: oral vitamin C tablets: oral tablet vitamin C tablet 500mg (b.d)twice a day along with other sympto9matic treatment and then asses for reduce in severity and duration of symptom<br>Intervention2: Intervention Group: Oral tablet vitamin C tablet 500mg (B.D)twice a day along with other symptomatic treatment till the symptoms relived or maximum 14 days,which ever earlier.<br>Control Intervention1: <br>control group: No vitamin C has been given to control group only symptomatic treatment will be given<br>Control Intervention2: control group: No vitamin C has been given to control group.Only symptomatic treatment will be given<br>→ | Improvement in illness can be assessed reduction in the grading (mild,moderate sever) of symptoms after l administration of vitamin C (5oomg, twice a day) in COVID19 patients. <br/ ><br>Timepoint: maximum time is 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/10/028774 | 27 January 2021 | Clinical evaluation of STANDARD Q COVID-19 Ag Test | Minimal risk, single-visit, cross-sectional study of STANDARD Q COVID-
19 Ag test compared to RT-PCR | | SD Biosensor | 29-10-2020 | 20201029 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48412 | Not Recruiting | No | | | | 30-10-2020 | 500 | Observational | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Niraj Kothari→ | | Gujarat Pathology Laboratory & Diagnostic Center,101-102, Span Trade
Center, Opp. Kochrab Ashram, Paldi Cross Road, Ahmedabad
→ | drniraj_patho09@yahoo.in→ | 079-26586480→ | Gujarat Pathology Laboratory & Diagnostic Center→ | Inclusion criteria: Samples are found SARS- CoV-2 negative with reference assay. <br/ ><br>- The subject is enrolled when â??Essential information for the specimenâ?? is permitted and <br/ ><br>[SDBCIP_ QCAG1-1] Rev.00 Page 6 / 8 <br/ ><br>provided consent for enrollment in the study→ | Exclusion criteria: Obstruction of 1 or more nares <br/ ><br>- Any condition that in the judgment of the investigator precludes participation because it could <br/ ><br>adversely affect subject safety or data integrity. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Interpretation of test results of STANDARD Q COVID-19 Ag TestTimepoint: days 0-3 more than 40 <br/ ><br>days 4-7 more than 40 <br/ ><br>days 7 more than 20→ | | | | Yes | False | | |
| → | CTRI/2020/10/028731 | 27 January 2021 | Higher vs. Lower Doses of Steroids in Patients with COVID-19 | Higher vs. Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia
- COVID STEROID 2 trial | | Professor Anders Perner | 29-10-2020 | 20201029 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46442 | Not Recruiting | No | | | | 01-11-2020 | 1500 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 3 | Denmark;India→ | Dr Vivekanand Jha→ | | George Institute for Global Health, India 311-312, Third Floor, Elegance Tower Plot No. 8, Jasola District Centre → | vjha@georgeinstitute.org.in→ | 911141588091→ | George Institute for Global Health→ | Inclusion criteria: All the following criteria must be fulfilled: <br/ ><br>Aged 18 years or above AND <br/ ><br>Confirmed SARS-CoV-2(COVID-19) requiring hospitalisation AND <br/ ><br>Use of one of the following: <br/ ><br>Invasive mechanical ventilation OR <br/ ><br>â?¢ Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR <br/ ><br>Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system <br/ ><br>→ | Exclusion criteria: Use of systemic corticosteroids for other indications than COVID-19 in doses higher than 6 mg dexamethasone equivalents <br/ ><br>Use of systemic corticosteroids for COVID-19 for 5 consecutive days or more <br/ ><br>Invasive fungal infection <br/ ><br>ctive tuberculosis <br/ ><br>Fertile woman ( <60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG <br/ ><br>Known hypersensitivity to dexamethasone <br/ ><br>Previously randomised into the COVID STEROID 2 trial <br/ ><br>Informed consent not obtainable <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Dexamethasone 12mg: Intervention period is up to 10 days from randomisation or until hospital discharge or death, whichever comes first.<br>Route: IV; Frequency: Once Daily<br>Control Intervention1: Dexamethasone 6mg: Intervention period is up to 10 days from randomisation or until hospital discharge or death, whichever comes first<br>Route: IV; Frequency: Once Daily<br>→ | Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisationTimepoint: Day 28→ | | | | Yes | False | | |
| → | CTRI/2020/10/028744 | 27 January 2021 | effect of COVID-19on physical activity, screen time and emotional wellbeing on medical students | Impact of COVID -19 Pandemic on Physical Activity, Screen Time And Emotional Well-Being of Medical Students of SMS Medical College,Jaipur (Raj) | | Anuradha Yadav | 29-10-2020 | 20201029 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48499 | Not Recruiting | No | | | | 20-11-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Anuradha Yadav→ | | SMS MEDICAL COLLEGE
DEPARTMENT OF PHYSIOLOGY → | dr.anuradhayadav@yahoo.co.in→ | 9414638469→ | SMS MEDICAL COLLEGE→ | Inclusion criteria: MBBS Students <br/ ><br>Both geneder <br/ ><br>Given consent→ | Exclusion criteria: Incomplete form→ | | | physical activity (light, moderate, vigorous), emotional wellbeing (positive and negative affect) scoring and total screen timeTimepoint: 4 week→ | | | | Yes | False | | |
| → | CTRI/2020/11/028799 | 27 January 2021 | The study of psychological interventions either individually or in groups and comparing its effect in reduction of psychological distress in covid-19 positive patients. | A Comparative study of Effectiveness of psychological interventions in COVID-19 positive patients. | | not funded | 02-11-2020 | 20201102 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45864 | Not Recruiting | No | | | | 02-11-2020 | 55 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India→ | Dr Tejaswini Miskin→ | | Department of psychiatry,opd no 33,
J.J.Hospital
Byculla
Mumbai → | tmiskin4@gmail.com→ | | Senior Resident, GGMC and Sir J.J. Hospital→ | Inclusion criteria: 18 t0 70 years both male and female with covid-19 infection→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | Intervention1: Comparative study of effectiveness of psychological interventions in COVID-19 positive patients: Not applicable<br>→ | DASS-21 questionnaire <br/ ><br>and mean scores of subscaleTimepoint: 1 week→ | | | | Yes | False | | |
| → | CTRI/2020/11/028813 | 27 January 2021 | Evaluation of antibody and cytokine detection in tears of COVID-19 patients | SARS-CoV-2 in ocular secretions: Role of inflammatory mediators in tears of COVID-19 patients to detect biomarkers of disease severity and prognosis | | PGIMER | 02-11-2020 | 20201102 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48182 | Not Recruiting | No | | | | 10-11-2020 | 120 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Reema Bansal→ | | Advanced Eye Centre,
Department of Ophthalmology,
PGIMER, Sector 12
Chandigarh → | drreemab@rediffmail.com→ | 09878011253→ | PGIMER→ | Inclusion criteria: COVID-19 positive patients will be recruited, including both adults and children. <br/ ><br>A total of 90 COVID patients [mild disease (30 patients), moderate (30 patients) and severe (30 patients)] will be enrolled, as per the ICMR criteria, along with 30 healthy controls.→ | Exclusion criteria: Patients not willing to give consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | Control Intervention1: NIL: NIL<br>→ | Detection of cytokines and anti COVID antibodies in tear and blood samples of COVID-19 patientsTimepoint: 6-8 months→ | | | | Yes | False | | |
| → | CTRI/2020/11/028811 | 27 January 2021 | Role of Physiotherapist in enhancing functional aerobic capacity in pulmonary rehabilitation in Covid-19 Patients. | Role of Physiotherapist in enhancing functional aerobic capacity in pulmonary rehabilitation in Covid-19 Patients. | | Apollo Hospitals Educational and Research Foundation AHERF | 02-11-2020 | 20201102 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48960 | Not Recruiting | No | | | | 07-11-2020 | 50 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | Seema Grover→ | | Indraprastha Apollo Hospital, Mathura Rd, New Delhi, 110076 Indraprastha Apollo Hospital, Mathura Rd, New Delhi, 110076→ | seema_g@apollohospitals.com→ | 9958819222→ | Indraprastha Apollo Hospitals→ | Inclusion criteria: 1.Age -20-60 <br/ ><br>2.Haemoglobin > 9 mmHg <br/ ><br>3.Covid positive patientâ??s mild, asymptomatic, moderate symptomatic with mild pneumonia. <br/ ><br>4.Respiratory rate less than 30 breaths/min. <br/ ><br>5.Spo2 more than 90%. <br/ ><br>6.No amputations or prostheses in lower extremities <br/ ><br>7.Able to ambulate and ability to complete all study protocol tests <br/ ><br>8.Likelihood of good compliance to the protocol. <br/ ><br>9.Approval by referring Physician. <br/ ><br>→ | Exclusion criteria: 1.Patient has immediate plans to transfer to outside hospital <br/ ><br>2.Patient requires significant doses of vasopressors for hemodynamic stability (maintain mean arterial pressure > 60 mm Hg) <br/ ><br>3.Patient is mechanically ventilated and requires Fio2â?¯ > 0.8 and/or positive end-expiratory pressure > 12 mm Hg, or has acutely worsening respiratory failure <br/ ><br>4.Patient is maintained on neuromuscular paralytic agents <br/ ><br>5.Patient has an acute neurologic event (e.g., cerebrovascular accident, subarachnoid haemorrhage, or intracranial haemorrhage) with reassessment for mobility every 24 hours <br/ ><br>6.Patient is unresponsive to verbal stimuli <br/ ><br>7.Patient has an unstable spine or extremity fracture <br/ ><br>8.Patient has a grave prognosis and is transferring to comfort care <br/ ><br>9.Patient has an open abdomen with a risk for dehiscence <br/ ><br>10.Severe pneumonia and on oxygen therapy. <br/ ><br>11.Breathing rate more than 30 breaths / min, spo2 less than 90. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Role of Physiotherapist in enhancing functional aerobic capacity in Pulmonary Rehabilitation in COVID 19 patients- A Pilot Study.: 1. Introduction to patient about study 2. Benefits of study to be explained to subjects 3. Informed consent 4. Pre-exercise assessment (detailed history &vitals to be checked) 5. Six minute walk test, WHOQOL-BREF,NODIC, rate of perceived exertion 6. Subject to be made comfortable, relaxed and followed by intervention. 7. Pulmonary Rehabilitation program 7.1 Warm up phase:diaphragmatic breathing 7.2. Main Phase 7.2.1 Aerobic Cycling 7.2.2 Range of motion exercises ( depending on patientâ??s condition as per physician clearance) 7.3 Cool-Down Phase Diaphragmatic Breathing 8. Post - exercise assessment (vitals ) 9. Intervention continues for 7 days(virtual/in person)10. All the assessment to be noted as pre intervention and post intervention at the given time points. 11. comparison and analysis to be done.<br>Intervention2: Role of Physiotherapist in enhancing functional aerobic capacity in Pulmonary Rehabilitation in COVID 19 patients-A pilot study.: 1. Introduction to patient about study 2. Benefits of study to be explained to subjects 3. Informed consent 4. Pre-exercise assessment (detailed history &vitals to be checked) 5. Six minute walk test, WHOQOL-BREF,NODIC, rate of perceived exertion 6. Subject to be made comfortable, relaxed and followed by intervention. 7. Pulmonary Rehabilitation program 7.1 Warm up phase:diaphragmatic breathing 7.2. Main Phase 7.2.1 Aerobic Cycling 7.2.2 Range of motion exercises ( depending on patientâ??s condition as per physician clearance) 7.3 Cool-Down Phase Diaphragmatic Breathing 8. Post - exercise assessment (vitals ) 9. Intervention continues for 7 days(virtual/in person)10. All the assessment→ | 1.VO2max.2.Rate of perceived exertion 3.WHOQOL-BREF 4. NODIC-Musculoskeletal questionnaireTimepoint: 7 days→ | | | | Yes | False | | |
| → | CTRI/2020/11/028800 | 27 January 2021 | Side effects of drugs used in ICU | "Pattern of adverse drug reaction in Covid-19 patients admitted in medical intensive care unit of a Covid-19 hospital" | | Government Institute of Medical Science | 02-11-2020 | 20201102 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49028 | Not Recruiting | No | | | | 13-11-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Nazia Nazir→ | | Department of Anesthesia and critical care, Main COVID ICU, → | nazunazir@gmail.com→ | 9560102957→ | Government Institute of Medical Science→ | Inclusion criteria: All Patients diagnosed with COVID 19 disease admitted in the COVID ICU will be included in the study.→ | Exclusion criteria: NIL→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J100- Influenza due to other identifiedinfluenza virus with pneumonia
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Adverse Drug reactionTimepoint: baseline, day 1, 2 , 3, 4, 5, 6, 7,8, 9, 10, 11,12, 13, 14,→ | | | | Yes | False | | |
| → | CTRI/2020/11/028779 | 27 January 2021 | Effect of SARS-CoV-2 Equine Antiserum Immunoglobulin (Purified F(ab)2 fragment) in hospitalised COVID-19 patients with moderate disease. | A phase I, open label, parallel, randomised trial to assess the safety and efficacy of SARS-CoV-2 Equine Antiserum Immunoglobulin (Purified F(ab)2 fragment) in hospitalised COVID-19 patients with moderate disease in addition to standard of care. - None | | Biological ELimited | 02-11-2020 | 20201102 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48578 | Not Recruiting | No | | | | 05-11-2020 | 72 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 1 | India→ | Dr Kishore TSA→ | | Pharmacovigilance Dept, 2nd floor, Road No.35, Jubilee Hills → | kishore.turaga@biologicale.com→ | 04071216247→ | Biological E.Limited→ | Inclusion criteria: 1. Both male and female patients aged between 18-55 years who signed the informed consent. <br/ ><br>2. Patients screened for Covid-19 by RT-PCR method â?¤72 hours from the date <br/ ><br>of RT-PCR confirmation and/or 7 days from the start of symptoms. <br/ ><br>3. Respiratory Rate > 24 breaths/min and SpO2 â?¤93% on room air <br/ ><br>4. Patients screened for intradermal sensitivity testing prior to initiation of infusion.→ | Exclusion criteria: 1.Pregnant women <br/ ><br>2. Breastfeeding women <br/ ><br>3. Known hypersensitivity to blood products and reactive to intradermal <br/ ><br>sensitivity test prior to infusion <br/ ><br>4. Receipt of pooled immunoglobulin in last 30 days <br/ ><br>5. Critically ill patients: <br/ ><br> a. Severe ARDS cases <br/ ><br> b. Shock (Requiring Vasopressor to maintain a <br/ ><br> MAP â?¥ 65mmHg or MAP below 65) <br/ ><br>6. Participating in any other clinical trial <br/ ><br>7. Clinical status precluding infusion of blood <br/ ><br> products <br/ ><br>8. Patients are not suitable for transfusion <br/ ><br> therapy; <br/ ><br>9. Patients with severe pneumonia defined as: RR <br/ ><br> â?¥30 times/min or oxygen saturation â?¤ 90% in <br/ ><br> resting state or PaO2/FiO2 â?¤ 100 mmHg or <br/ ><br> respiratory failure and mechanical ventilation <br/ ><br> are required or shock occurs or ICU <br/ ><br> monitoring with presence of other organ <br/ ><br> failure; <br/ ><br>10. Acute life-threatening organ dysfunction <br/ ><br> caused by a dys-regulated host response to <br/ ><br> suspected or proven infection. (Signs of organ <br/ ><br> dysfunction include: altered mental status, <br/ ><br> difficult or fast breathing, low oxygen <br/ ><br> saturation, reduced urine output, fast heart <br/ ><br> rate, weak pulse, cold extremities <br/ ><br> or low blood pressure, skin mottling, or <br/ ><br> laboratory evidence of coagulopathy, <br/ ><br> thrombocytopenia, acidosis, high lactate or <br/ ><br> hyperbilirubinemia). <br/ ><br>11. Patients on any other immunoglobulin or <br/ ><br> immunomodulatory treatment; <br/ ><br>12. Patients with known history of allergy to <br/ ><br> horse proteins or severe allergic reactions <br/ ><br> to any component of the Equine antiserum;→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: SARS-CoV-2 (COVID-19) Antiserum<br>Immunoglobulins (Purified F(ab)2 fragment along with standard of<br>care: Patients in this group will receive two 4mL<br>doses (at day 0 and Day 1) of BioEâ??s SARS-CoV-2 (COVID-19) Antiserum Immunoglobulins<br>(Purified F(ab)2 fragment) intravenously along with standard of care.<br>Control Intervention1: Standard care for Covid-19 patients: Patients in this group will receive only standard of care for Covid-19<br>patients.<br>→ | Proportion of patients with treatment-emergent adverse events including infusion related reactionsTimepoint: Day 0 Through Day 28→ | | | | Yes | False | | |
| → | CTRI/2020/11/028836 | 27 January 2021 | Correlating the Clinical and CT Severity of COVID-19 patients with the Inflammatory markers and Co-morbidities | Correlating the Clinical and CT Severity of COVID-19 patients with the Inflammatory markers and Co-morbidities | | Aparna | 03-11-2020 | 20201103 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48390 | Not Recruiting | No | | | | 15-11-2020 | 200 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Aparna Ganesh→ | | Department of General Medicine,
G Block, Sri Ramachandra Institute of Higher Education and Research,
No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu → | preetam_arthur@yahoo.co.in→ | | Sri Ramachandra University→ | Inclusion criteria: Patients > 18 years who have tested positive for COVID-19 either by RT-PCR or CB-NAAT→ | Exclusion criteria: Patients < 18 years. <br/ ><br>Patients with consolidation/pneumonia due to other organisms than the SARS CoV-2 virus. <br/ ><br>Patients with coexisting infections apart from COVID-19. <br/ ><br>Patients with chronically elevated inflammatory markers due to other inflammatory conditions, like Autoimmune conditions. <br/ ><br>Pregnant patients→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Obtaining correlation between the inflammatory markers, comorbidities and the CT and Clinical severity of COVID-19 patients.Timepoint: At Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/11/028846 | 27 January 2021 | A study on knowledge, attitude and behavior of healthcare workers on practices required to prevent COVID - 19 | Knowledge, Attitude and behavior on infection prevention and control
practices of employee of a tertiary care teaching hospital in COVID- 19 Pandemic | | NONE | 03-11-2020 | 20201103 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48947 | Not Recruiting | No | | | | 11-11-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Chirag Modi→ | | Department of Microbiology
Pramukhswami Medical College
Gokalnagar
Karamsad → | chiragmm@charutarhealth.org→ | 9727739203→ | Pramukhswami Medical College→ | Inclusion criteria: All employees involved in patient care shall be included in the study.→ | Exclusion criteria: None→ | | | Level of knowledge, attitude and behavior on infection control practicesTimepoint: 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/11/028827 | 27 January 2021 | Yoga program on COVID 19 patients | Effect of an integrated Yoga program on stress, mood states, sleep quality, symptom severity, quality of life and clinical outcomes in Covid19 positive patients undergoing conventional treatment : a Multicentric trial | | Central Council for Research in Yoga and Naturopathy Ministry of AYUSH | 03-11-2020 | 20201103 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46946 | Not Recruiting | No | | | | 04-11-2020 | 86 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | N/A | India→ | Dr Raghavendra Rao M→ | | Department of Research, Division of Yoga, Room No 107, Central Council for Research in Yoga and Naturopathy CCRYN, Ministry of AYUSH, 61 65, Institutional Area, Opp D Block, Janakpuri, New Delhi → | ccryn.director@gmail.com→ | 9916488864→ | Central Council for Research in Yoga & Naturopathy (CCRYN)→ | Inclusion criteria: 1.Covid 19 positive case diagnosed using RT PCR in authorized Covid19 testing facility <br/ ><br>2.Mild clinical presentation (identified at the time of admission to ward by National Early Warning Score NEWS-2; mild 0-4; severe 5-6) <br/ ><br>3.Presenting with or without flu symptoms <br/ ><br>4.Aged 18-60 years <br/ ><br>5.High school education <br/ ><br>6.Written consent to participate in any arm of the study <br/ ><br>7.Those having a smart phone mobile device with android or IOS operating system. <br/ ><br>→ | Exclusion criteria: 1.Severe infection News-3-4 requiring admission to ICU. <br/ ><br>2.Unable to take oral medication, <br/ ><br>3.Immunocompromised, <br/ ><br>4.Creatinine clearance (CCL) < 30 ml/min, <br/ ><br>5.Aspartate transaminase (AST) or alanine transaminase (ALT) > 5 times Upper limit of normal (ULN), <br/ ><br>6.d-dimer > 2microgram per liter, or <br/ ><br>7.Uncontrolled diabetes, Hypertension, Existing Heart disease and heart failure, any cancer, autoimmune disease, stroke, neurodegenerative diseases etc.. <br/ ><br>8.Clinical condition that reduces survival to less than six months. <br/ ><br>9.Pregnancy and lactating mothers <br/ ><br>10.Clinical signs suggestive of septicemia and multi organ dysfunction. <br/ ><br>11. Score of less than 24 points on the Folstein Mini-Mental State Examination(43). <br/ ><br>12.Score of more than 14 points on the 9-item Patient Health Questionnaire (PHQ-9) depression screen (44). <br/ ><br>13.BMI less than 18 <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Test Group: Integrated biofeedback based yoga program<br>Covid 19 patients take part in a 2 week Integrated biofeedback based yoga program following admission to a tertiary Covid 19 screening and treatment center<br>: <br>Patients are asked to practice 3-4 times a day over a 14-day period with each session lasting over 20 minutes.<br>Control Intervention1: Covid 19 patients take part in control group receive standard care following admission to a tertiary Covid 19 screening and treatment center.: They will also receive counselling to allay their anxiety in addition to their routine treatment<br>→ | The primary outcome will be defined as area-under-the curve global severity for all ARI illness days throughout observation, from consent to study exitTimepoint: Day 0 to study exit→ | | | | Yes | False | | |
| → | CTRI/2020/11/028843 | 27 January 2021 | Outcomes of Nutrition scores on serious COVID patients | The Outcomes of NUTRIC and mNUTRIC scores on Critically ill COVID patients- A Prospective Observational Cohort study | | Safdarjung Hospital | 03-11-2020 | 20201103 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49036 | Not Recruiting | No | | | | 09-11-2020 | 78 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Saurav Mitra Mustafi→ | | Department of Anaesthesia
VMMC Safdarjung Hospital → | saurav82in@yahoo.co.in→ | 09899124943→ | VMMC Safdarjung Hospital New Delhi→ | Inclusion criteria: All except exclusion criteria→ | Exclusion criteria: Patients less than 18 years of age <br/ ><br>Pregnant <br/ ><br>Peptic ulcer as in pre existing GI conditions Those having mortality within 48 hours would be excluded from the study. <br/ ><br>Patients who would be admitted to the hospital for some cause other than COVID and subsequently developed COVID would also be eliminated from the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. To investigate the outcome of poor nutritional status validated by NUTRIC score in critically ill COVID patients. <br/ ><br>2. To investigate the outcome of poor nutritional status validated by mNUTRIC score in critically ill COVID patients. <br/ ><br>Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/11/028848 | 27 January 2021 | Lifestyle and psychological changes during COVID 19 lockdown among undergraduate students in Chennai | Lifestyle and psychological changes during COVID 19 lockdown: online survey among undergraduate students of a teaching and research institute in Chennai | | nil | 03-11-2020 | 20201103 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49115 | Not Recruiting | No | | | | 16-11-2020 | 526 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Akila GV→ | | 2141, tower 2a, prestige bella vista
kattupakam No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116→ | aki_ravi24@yahoo.co.in→ | 9902308147→ | Sri Ramachandra Institute of Higher Education and Research→ | Inclusion criteria: 1.Students from final year of MBBS, BDS, BPT, BPharm <br/ ><br>2.All those who give informed consent <br/ ><br>→ | Exclusion criteria: 1.Unwilling participants <br/ ><br>2.Students doing their internship <br/ ><br>→ | | | Difference in physical activity, dietary pattern, screen time usage, and sleep before and during lockdown.Timepoint: at the end of 3 months after start of study→ | | | | Yes | False | | |
| → | CTRI/2020/11/028859 | 27 January 2021 | Cancer Services during COVID-19 Pandemic â?? Importance of a symptoms based screening strategy | Continuation of Cancer Services in a prospective cohort during COVID-19 Pandemic â?? Policy implications of a symptoms based screening strategy | | All India Institute of Medical Sciences | 03-11-2020 | 20201103 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49144 | Not Recruiting | No | | | | 11-11-2020 | 400 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Akash Kumar→ | | 2nd Floor, Dept of Medical Oncology, BRAIRCH, AIIMS→ | akashja08@yahoo.com→ | 91-9910850134→ | All India Institute of Medical Sciences→ | Inclusion criteria: a) All COVID -19 seronegative cancer patients who are planned for active chemotherapy and or radiotherapy during the next 60 days at Department of Medical Oncology IRCH / NCI and/or Department of Radiotherapy at NCI.→ | Exclusion criteria: a) Patients who are seropositive at baseline or have a history of COVID-19 related symptoms over last 14 days of date of recruitment. <br/ ><br>b) Patients who have a history of recovery from documented COVID-19 infection in past. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Proportion of asymptomatic patients with successful completion of cancer directed therapy during the study periodTimepoint: 6 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/11/028905 | 27 January 2021 | An academic trial to study the prophylactic activity of Vishasura Kudineer(VSK)in healthcare workers exposed/non-exposed to COVID-19 patients. | Clinical evaluation for the prophylactic role of traditional Siddha formulation Vishasura
Kudineer enlisted in Advisory of Ministry of AYUSH for COVID-19 - VSK | | Ministry of AYUSH | 04-11-2020 | 20201104 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48668 | Not Recruiting | No | | | | 12-11-2020 | 120 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 1/ Phase 2 | India→ | Dr R Shailaja→ | | Siddhar Research Institute, 3/10, Nammalvar street, Jagadambigai nagar, Padi, Chennai → | livshiva@gmail.com→ | 8925744196→ | Narayana Medical College→ | Inclusion criteria: Based on their personal and medical history; as well post clinical examination that includes biochemical, hematological and urinary parameters and also vital parameters such as - BP (100 â?? 139 mmHg systolic and 60â??89 mmHg diastolic); pulse rate in the range of 60â??100/min. Body <br/ ><br>temperature between 97.8 Ì? F and 99.0 Ì? F. Respiratory rate should be within the range of 14-18/min; will be included in this study. These volunteers should also be non-tobacco smoking or smokes <5 cigarettes/day and willing to give informed consent and comply with study <br/ ><br>requirements will be recruited.→ | Exclusion criteria: History of any major surgical procedure in the past 3 months or with ailments such as <br/ ><br>diabetes mellitus, tuberculosis, dysphagia and systemic hypertension. <br/ ><br> <br/ ><br>History suggestive of cardiac, gastrointestinal, respiratory, hepatic, renal, endocrine, <br/ ><br>neurological, metabolic, psychiatric or hematological systems, judged to be clinically <br/ ><br>significant; and any other medical disorder that is of significance in the investigatorâ??s opinion→ | | Intervention1: VSK decoction: 60 mL b.i.d for 1 month<br>Intervention2: Vishasura Kudineer (VSK), a Siddha Formulation: The herbs used in VSK - 1.Azadirachta indica; 2. Indigofera tinctorial; 3. Zingiber officinale; 4. Hemidesmus indicus; 5. Aristolochia bracteolate; 6. Vetiveria zizanioides; 7. Glycyrrhiza glabra; 8. Elettaria cardamomum; 9. Santalum album<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | Chemical composition of VSK is expected to function as exogenous antioxidant and <br/ ><br>reduce the reactive oxygen species and enhance the endogenous antioxidants of the body; <br/ ><br>further it could prevent the cytokine storm and boost the immunity of the health care <br/ ><br>workers and thereby prevent the morbidity and mortality.Timepoint: one Month→ | | | | Yes | False | | |
| → | CTRI/2020/11/028903 | 27 January 2021 | Telephonic intervention for people tested positive for Covid | Psychosocial Intervention for people who are tested positive for Covid19 | | Dr Jeyaram | 04-11-2020 | 20201104 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48964 | Not Recruiting | No | | | | 09-11-2020 | 0 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Jeyaram→ | | Department of Psychiatry,
Yenepoya Medical College Hospital,
Deralakatte → | jayaramsrinivasan@yenepoya.edu.in→ | 08242206000→ | Yenepoya Medical College Hospital→ | Inclusion criteria: Individuals aged 18 years and above <br/ ><br>Individuals undergoing inpatient care at YMCH <br/ ><br>→ | Exclusion criteria: Individuals who refuse to participate <br/ ><br>People who are severely mentally disturbed, which includes people who expresses suicidal intent would be dropped from the study (referral to psychiatrist support would be made) <br/ ><br>Persons who initially expresses willingness and later withdraws to participate in the study would be excluded from the study <br/ ><br>Individuals who are moved to intensive care unit would be excluded due to deterioration in their health condition. <br/ ><br>Discontinuation criteria: <br/ ><br>Participants refusal to continue with the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Interventional research design with pre and post test without control.: Each of the study participant would be receiving a phone call in their given mobile number. They would be explained about the study and an oral consent to participate would be taken over phone and the same would be recorded. The participant would be explained and assured that refusal to participate in the study would not affect standard of care. The researchers would elicit socio demographic data and assess mental health issues of the individual who are quarantined and a point of contact will be established here. The questionnaires Self Reporting Questionnaire (SRQ), Impact of event scale â?? revised (IES-R), and Perceived Stress Scale â?? 14 (PSS) would be administered over telephone and responses would be noted down by the researchers. The researcher would contact the participants on alternate days. until the day of discharge from hospital. Each tele counselling session may last upto 15 minutes.<br><br>Tele counselling would incorporate umbrella of care services as necessitated by WHO on covid19 pandemic, such as informational help on novel coronavirus, supportive psychosocial care, working out a routine while under quarantine and any other legal, medical and paralegal services and referrals as appropriate would be made.<br><br>Effectiveness of the tele counselling would be tested against the application of Self Reporting Questionnaire (SRQ), Impact of Event Scale (IES) - Revised and Perceived Stress Scale (PSS) â?? 14 during the initial contact. The same three scales would be used again at the time of discharge from the hospital, which would help track the effectiveness of tele counselling. <br><br><br><br><br>Control Intervention1: Not Applicable: Not Applicable<br>→ | Tele counselling will improve the mental health of the individualsTimepoint: Baseline and at the time of discharge which is likely to be 2 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/11/028897 | 27 January 2021 | To Evaluate the Efficacy and Safety of ANT-V Syrup to show antiviral action of upper respiratory
tract like common cold and act as an immune booster to fight against infection, flu, fever, sore
throat, nasal and chest congestion Breathlessness in COVID-19 patients. | A Prospective, Interventional, Randomized, Double blind, placebo Controlled, Clinical Study to Evaluate the Efficacy and Safety of ANT-V Syrup of Bhargava Phytolab Pvt. Ltd., to show antiviral action against Covid-19 (Asymptomatic and mild cases) and act as immune booster to fight against infection, flu, fever, sore throat, nasal and chest congestion and breathlessness | | Bhargava Phytolab Pvt Ltd | 04-11-2020 | 20201104 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48480 | Not Recruiting | No | | | | 16-11-2020 | 60 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Pragya Singh→ | | Bhargava Phytolab Pvt Ltd
B-92 Sector 2 Noida
B-92 Sector 2 Noida
→ | research@nimsuniversity.org→ | 9911167389→ | The National Institute of Medical Sciences & Research,→ | Inclusion criteria: -Male or Female having the age of 18 to 55 years. <br/ ><br>-Presented symptoms of recent onset, for more than 6 hours and <br/ ><br>less than 72 hours, characterizing one of the following conditions: <br/ ><br>The viral infection on upper respiratory tract like common cold, which <br/ ><br>consists of at least 2 symptoms among the 10 following- sneezing, <br/ ><br>rhinorrhea, nasal congestion, headache, muscle pain, discomfort in <br/ ><br>the throat, sore throat, dysphonia/congestion of chest, cough, fever, <br/ ><br>fatigue, the latter being of moderate to severe intensity through a <br/ ><br>symptom severity scale of 4 points (0 none, 1 mild, 2 moderate, 3 <br/ ><br>severe) <br/ ><br>-The flu syndrome, which consists of fever of at least 101. F and <br/ ><br>headache of moderate or severe intensity or myalgia / arthralgia <br/ ><br>moderate or severe using a scale of severity of symptoms of 4 points <br/ ><br>(0 none, 1 mild, 2 moderate, 3 severe) <br/ ><br>-Willing to provide written informed consent for participation in the <br/ ><br>study and adhere to the protocol requirements.→ | Exclusion criteria: -Patients who are not willing to give written informed consent. <br/ ><br>-Any known hypersensitivity to the study products. <br/ ><br>-Pregnant and lactating women. <br/ ><br>-Patients who have taken treatment for the presenting symptom <br/ ><br>within 7 days of screening. <br/ ><br>-Any history of drug abuse /chronic alcoholism <br/ ><br>-Patients who received influenza vaccine within 7 days of screening. <br/ ><br>-Patients who in the opinion of attending physician may require <br/ ><br>antibiotic treatment. <br/ ><br>-Participation in any clinical trials prior to 12 months. <br/ ><br>-Severely immune compromised patients and who is on <br/ ><br>immunosuppressant and anti-viral medication. <br/ ><br>-Patients with positive serology laboratory values. <br/ ><br>-Use of any investigational drug currently or within 30 days prior to <br/ ><br>study entry. <br/ ><br>-Subjects on any prescription medication that might interfere with <br/ ><br>study outcomes. <br/ ><br>-Patients with severe hepatic, renal insufficiency. <br/ ><br>-History of alcohol or drug abuse. <br/ ><br>-Patient with any underlying disease like diabetes, asthma, heart <br/ ><br>disease, cancer, HIV or any other. <br/ ><br>-Recent Heart surgery, on medication post-surgery. <br/ ><br>-Allergic to a similar drug or ingredients in the drug.→ | Health Condition 1: J00- Acute nasopharyngitis [common cold]
Health Condition 2: B342- Coronavirus infection, unspecified
Health Condition 3: J108- Influenza due to other identifiedinfluenza virus with other manifestations
Health Condition 4: R070- Pain in throat
→ | Intervention1: ANT-V Syrup: Patients will be administered 10ml of ANT-V Syrup Formulation thrice a day (TID) for 7 days.<br>Each 100 ml of ANT-V Syrup contains<br>-- Ocimum<br>sanctum Q -- 1ml Tinospora<br>cordifolia Q -- 1ml Glycyrrhiza<br>glabra Q -- 0.5 ml Echinacea<br>angustifolia Q -- 1ml Justicia<br>adhatoda 3x -- 0.5ml Bryonia<br>album 3x --0.5ml Rhus<br>toxicodendron 3x --0.5ml<br>Arsenic album 30 -- 0.5ml<br>Withania somnifera Q â?? 1ml<br>Belladona 3X. -- 0.5ml In syrup<br>base -- q.s<br>Control Intervention1: NIL: NIL<br>→ | Assess the symptomatic relief of viral infection <br/ ><br>like common cold, flu, fever, sore throat, nasal <br/ ><br>and chest congestion etc. <br/ ><br>â?¢To evaluate the pro-inflammatory cytokine (i.e. <br/ ><br>IL-6) in the response of immunity. (Time frame:- <br/ ><br>Baseline to EOT)Timepoint: Baseline (Day 0) <br/ ><br>Day 7 (EOT Visit) <br/ ><br>Day 14 (Follow up Visit)→ | | | | Yes | False | | |
| → | CTRI/2020/11/028885 | 27 January 2021 | Frailty assessment for COVID-19 severity | Frailty as a predictor of clinical severity in geriatric COVID-19 patients: A prospective observational study.
| | AIIMS Hospital | 04-11-2020 | 20201104 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47990 | Not Recruiting | No | | | | 09-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Yudhyavir Singh→ | | Room No- 322A, JPNATC,AIIMS → | yudhyavir@gmail.com→ | 09811140057→ | AIIMS→ | Inclusion criteria: 65 years and above→ | Exclusion criteria: 1. Not giving consent <br/ ><br>2. Trauma patients <br/ ><br>3. Non-responsive patients <br/ ><br>4. Intubated patients <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Nil<br>→ | 1. Admission frailty Scores <br/ ><br>2. Mortality <br/ ><br>Timepoint: At 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/11/028938 | 27 January 2021 | Ultrasonography in Covid19 patients with a focus on possible clinical diagnosis and management decisions | Focused ultrasonography in Covid19 patients-a pragmatic approach - FUSIC | | Manju Mathew | 05-11-2020 | 20201105 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48595 | Not Recruiting | No | | | | 19-11-2020 | 44 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Manju Mathew→ | | Department of critical care, ground floor, Pushpagiri medical college hospital,Thiruvalla Pathanmthitta Kerala → | dr.tresamaria@gmail.com→ | 9188805215→ | Department of critical care, Pushpagiri medical college hospital,Thiruvalla→ | Inclusion criteria: 1 Patients admitted in the COVID ICU who undergo ultrasound by the intensivists for hypoxemia (SpO2 <94) and hypotension (Systolic BP <90mmHg) <br/ ><br>2 Above 18 years of age <br/ ><br>3 COVID19 RT PCR test positive <br/ ><br>→ | Exclusion criteria: Covid19 RT PCR positive patients admitted in COVID ICU who does not have an indication for ultrasonography→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: nil: nil<br>→ | To find the ageement between ultrasound diagnosis and final clinical diagnosisTimepoint: Single→ | | | | Yes | False | | |
| → | CTRI/2020/11/028967 | 27 January 2021 | Seroprevalence of COVID-19 antibodies | Seroprevalence of COVID-19 antibodies in patients on disease modifying anti-rheumatic drugs â?? Multicentric study | | Kalinga Institute of Medical Sciences KIMS Regional Medical Research Center ICMR Bhubaneswar | 06-11-2020 | 20201106 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47399 | Not Recruiting | No | | | | 15-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ramnath Misra→ | | Room 139,
Superspeciality block
Campus 5
Department of Rheumatology,
KIMS hospital, KIIT University KIIT Road, Bhubaneswar, 751024,
Odisha→ | ramnath.misra@kims.ac.in→ | 9415006688→ | Kalinga Institute of Medical sciences, KIIT University→ | Inclusion criteria: 1. Relative of patient being included in the study, preferably staying the same household. <br/ ><br>2. No known rheumatic diseases <br/ ><br>→ | Exclusion criteria: 1. Acquired immunodeficiency syndrome <br/ ><br>2. Any active infection as indicated by patient being on systemic antibiotics, anti-fungals or anti-mycobacterial chemotherapy <br/ ><br>3. Pregnancy , chronic renal failure , chronic liver disease, diabetes mellitus <br/ ><br>4. Any known malignancy or has received chemotherapy in the last six months <br/ ><br>5. Patients who have received plasma therapy (for COVID-19) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: Nil: Nil<br>→ | Comparison of antibody levelTimepoint: 4 months (2 months sample collection, 1 month lab analysis, 1 month manuscript preparation)→ | | | | Yes | False | | |
| → | CTRI/2020/11/028954 | 27 January 2021 | Psychological burden in COVID19 | Psychological burden and coping in hospitalized COVID19 patients | | All India Institute of Medical Sciences AIIMS | 06-11-2020 | 20201106 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48686 | Not Recruiting | No | | | | 10-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | N/A | India→ | Bichitra Nanda Patra→ | | Department of Psychiatry
All India Institute of Medical Sciences (AIIMS)
Ansari Nagar
New Delhi. India → | patrab.aiims@gmail.com→ | 9717880196→ | All India Institute of Medical Sciences (AIIMS)→ | Inclusion criteria: -Patients who are admitted in the COVID ward of AIIMS, JPNA trauma center <br/ ><br>-Recorded SARS-CoV-2 test result positive (RT-PCR of nasopharyngeal/ oropharyngeal swab) <br/ ><br>-Patients not requiring oxygen support and maintaining on room air <br/ ><br>-Age 18-60 years→ | Exclusion criteria: -Any patient having difficulty to participate in interview (e.g. severe illness, very sick, on oxygen or ventilator, delirium etc.) <br/ ><br>-Patients having psychosis or difficulty in comprehending the questions <br/ ><br>→ | Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: F32- Major depressive disorder, singleepisode
→ | | Depression, Anxiety and coping strategies used by COVID19 patientsTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/11/028968 | 27 January 2021 | A study to observe the trend of SARS-CoV-2, Dengue and Chikungunya infection transmission in the general population. | Establish serial sero-surveillance to monitor the trend of SARS-CoV-2, Dengue and Chikungunya infection transmission in the general population. - Sero-survey | | National Biopharma Mission NBM Biotechnology Industry Research Assistance Council BIRAC | 06-11-2020 | 20201106 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49216 | Not Recruiting | No | | | | 18-11-2020 | 5000 | Observational | Other<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrYuvarajJayaraman→ | | ICMR-NIE,2nd Main Road, Ayapakkam, Chennai → | j_yuvan@yahoo.com→ | 9843323166→ | Indian Council of Medical Research-National Institute of Epidemiology→ | Inclusion criteria: Survey will be carried out in individuals above 2 years of age and all individuals currently residing and likely to stay till the end of study (1 year) in the study area will be considered eligible for inclusion.→ | Exclusion criteria: Consent refusal→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: A90- Dengue fever [classical dengue]
Health Condition 3: B978- Other viral agents as the cause ofdiseases classified elsewhere
→ | Intervention1: NA: NA<br>→ | 1.Determining the burden of COVID 19 infection at the community level and monitor the trends in transmission of SARS-CoV-2 infection. <br/ ><br>2.Risk factors for infection can be identified which might inform future control strategies.Timepoint: Outcome 1: 12 months <br/ ><br>Outcome 2: 12 months→ | | | | Yes | False | | |
| → | CTRI/2020/11/028969 | 27 January 2021 | Effect Of COVID-19 on breast cancer treatment and its outcome | Impact of COVID-19 pandemic on breast cancer management in a Tertiary Cancer Care Centre: A case control study | | NA | 06-11-2020 | 20201106 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49266 | Not Recruiting | No | | | | 16-11-2020 | 900 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Jince Mary Mathew→ | | Room no-602, Tata PG Hostel,
Anushakti Nagar. → | drrajivsarin@gmail.com→ | 9820313789→ | Tata Memorial hospital→ | Inclusion criteria: INCLUSION CRITERIA COVID Case Cohort <br/ ><br>1. Histologically confirmed breast cancer <br/ ><br>2. Age more than 18years, female or male <br/ ><br>3. Registered at TMC during the COVID-19 Mumbai lockdown starting from 25th March 2020 <br/ ><br>Or <br/ ><br>Registered in TMC after 1st May 2019 and still receiving or expected to be receiving active treatment (except oral hormone therapy) during the lockdown in Mumbai <br/ ><br>INCLUSION CRITERIA Control Cohort: <br/ ><br>1. Histologically confirmed primary breast cancer <br/ ><br>2. Age more than 18years, female or male <br/ ><br>3. Registered at TMC during the period 1st February to 30th April 2019 <br/ ><br>→ | Exclusion criteria: EXCLUSION CRITERIA CASES <br/ ><br>1. Registered in TMC after partial or full treatment outside (except incision/excision biopsy) <br/ ><br>2. Not willing and providing consent for telephonic interview <br/ ><br>EXCLUSION CRITERIA CONTROLS <br/ ><br>1. Registered in TMC after partial or full treatment outside (except incision/excision biopsy) <br/ ><br>2. Not willing and providing consent for telephonic interview <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C509- Malignant neoplasm of breast of unspecified site
→ | | To determine the proportion of breast cancer patients who could not receive the TMC Standard of Care (SOC) multimodality treatment in the COVID and Pre-COVID cohortsTimepoint: 6 months - initial analysis and then 2 and 5 years→ | | | | Yes | False | | |
| → | CTRI/2020/11/028959 | 27 January 2021 | Effect of recombinant erythropoietin in covid-19 patients. | Comparison of outcome in Coronavirus disease 2019 (COVID-19) pneumonia patients with or without recombinant erythropoietin (r-EPO) â?? a prospective randomized controlled study. | | All India Institute Of Medical Sciences New Delhi | 06-11-2020 | 20201106 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48272 | Not Recruiting | No | | | | 06-11-2020 | 40 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable | N/A | India→ | ashutosh kumar singh→ | | Department of Anaesthesia, Pain medicine and Critical care.
JPNATC, AIIMS NEW DELHI → | anjantrikha@gmail.com→ | 9810977901→ | AIIMS NEW DELHI→ | Inclusion criteria: sars-cov-2 positive patients. <br/ ><br>moderate to severe disease who require non-invasive or invasive ventilation.→ | Exclusion criteria: patients relative refusal. <br/ ><br>terminal end-organ failure (renal, liver, cardiac, cns) <br/ ><br>thrombocytosis. <br/ ><br>concomitant potential serious infections.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J22- Unspecified acute lower respiratory infection
→ | Intervention1: recombinant erythropoietin (r-EPO)in addition to standard care.: In 20 moderate to severely diseased patients who require ventilatory support(NIV/IV), 4000IU of r-EPO in addition to standard care would be administered subcutaneously on day 1, 2, 4 and 7th days.<br>Control Intervention1: only standard care.: In 20 number of moderate to severely diseased patients only standard care treatment protocol will be followed.<br>→ | Deescalation from mechanical ventilation and mortality benefit.Timepoint: 02 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/11/028976 | 27 January 2021 | A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Immunogenicity,and Lot-to-Lot consistency of BBV152, a Whole virion Inactivated Vaccine in Adults greater than or equal to 18 Years of Age. | An Event-Driven,Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy, Safety, Immunogenicity,and Lot-to-Lot consistency of BBV152, a Whole virion Inactivated SARS-CoV-2 Vaccine in Adults greater than or equal to 18 Years of Age. - COVID Phase 3 Study | | Bharat Biotech International Ltd | 09-11-2020 | 20201109 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48057 | Not Recruiting | No | | | | 11-11-2020 | 25800 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 3 | India→ | Dr Shashikanth Muni→ | | Medical Affairs Department, Bharat Biotech International Ltd,
Genome valley, Shameerpet → | kmohan@bharatbiotech.com→ | 914023480567→ | Bharat Biotech International limited→ | Inclusion criteria: 1. Ability to provide written informed consent and availability to fulfill the study requirements. 2. Participants of either gender of aged 18 years and above. 3. Participants with good general health as determined by the discretion of the investigator, or participants with stable medical conditions. A stable medical condition is defined as a disease not requiring significant change in therapy or hospitalization or worsening disease during the 3 months before enrolment. 4. For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least eight weeks after the last vaccination. 5. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner and to refrain from sperm donation from first vaccination until at least 3 months after the last vaccination. 6. Agrees not to participate in another clinical trial at any time during the study period. 7. Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study. 8. Agrees to remain in the study area for the entire duration of the study. 9. Willing to allow storage and future use of biological samples for future research.→ | Exclusion criteria: 1. History of any other COVID-19 investigational or licensed vaccination. 2. Known history of SARS-CoV-2 infection, as declared by the subject. 3. For women, positive urine pregnancy test before the first dose of vaccination, or any time during the study period. 4. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. 5. Resident of COVID-19 infection in same household. <br/ ><br>6. Known case of HIV, hepatitis B, or hepatitis C infection. 7. Receipt of any licensed/experimental vaccine within four weeks before enrolment in this study. 8. Receipt of immunoglobulin or other blood products within the three months before vaccination in this study. 9. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. 10. Immunoglobulins, anti-cytokine antibodies and blood products within 6 months prior to study vaccination, during and 21 days following last dose of vaccination. 11. Pregnancy, lactation, or willingness/intention to become pregnant during the first 6 months after enrolment. 12. Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder,, and neurological illness (mild/moderate well-controlled comorbidities are allowed) <br/ ><br>Re-Vaccination Exclusion Criteria 13. Pregnancy. 14. History of virologically (RT-PCR) confirmed SARS-CoV-2 infection 15. Anaphylactic reaction following administration of the investigational vaccine.→ | | Intervention1: BBV152B: 6 µg antigen with Algel-IMDG: Whole-Virion Inactivated SARS-CoV-2 vaccine (BBV152) will be administered as a two dose intramuscular injection 28 days apart.<br>Control Intervention1: Placebo<br>(Phosphate buffered saline with Algel): Phosphate buffered saline with Alum (without antigen) will be used as the control.will be administered as a two dose intramuscular injection 28 days apart.<br>→ | To evaluate the efficacy of BBV152B to prevent symptomatic COVID-19(Virologically confirmed-(RT-PCR positive) which include any participant who meets the Case Definitions for Symptomatic Endpoint and Severe Symptomatic COVID-19Timepoint: Day 42 to Month 12→ | | | | Yes | False | | |
| → | CTRI/2020/11/029025 | 27 January 2021 | An open label observational study on post covid complications and radiological pattern changes on those patients treated with ZingiVir H . | AN OPEN LABEL SINGLE CENTRE PROSPECTIVE OBSERVATIONAL STUDY TO EVALUATE THE RADIOLOGICAL PATTERNS:POST COVID 19 COMPLICATIONS AND CLINICAL OUTCOME RESOLUTIONS OF LUNGS AND BRAIN IN COVID 19 CONFIRMED PATIENTS TREATED WITH AN ANTIVIRAL DRUG ZingiVir-H. | | Pankajakasthuri herbal research foundation | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49174 | Recruiting | No | | | | 15-11-2020 | 60 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr J Hareendran Nair→ | | Pankajakasthuri Herbal Research Foundation,
Kattakkada,Thiruvanathapuram Kattakkada,Thiruvanathapuram→ | drshan@pkhil.com→ | 9188325339→ | Pankajakasthuri Herbal Research Foundation→ | Inclusion criteria: Patients of both sexes aged 18 years and older. <br/ ><br>Willing and able to provide written informed consent prior to performing study <br/ ><br>procedures by the subject or legal guardian willing and able to provide written informed <br/ ><br>consent prior to performing study procedures Patients with Severe Acute Respiratory Syndrome Coronavirus SARS-CoV2 COVID19 <br/ ><br>infection confirmed by RT Polymerase chain reaction RT-PCR test <br/ ><br>PCR positive in sample collected lesser than 96 hours prior to enrollment; <br/ ><br>Currently hospitalized and requiring medical care for COVID-19 atleast ONE of the <br/ ><br>following co-morbid risk factor <br/ ><br>Age above 60 years <br/ ><br>Documented history of coronary artery disease <br/ ><br>Heart failure New York Heart Association Class 3 or 4 <br/ ><br>Hypertension, requiring at least 1 prescription medicine for management. <br/ ><br>Dyslipidemia, requiring at least 1 prescription medicine for management. <br/ ><br>Chronic lung disease eg, asthma or chronic obstructive pulmonary disease requiring <br/ ><br>treatment <br/ ><br>Documented history of stroke <br/ ><br>Diabetes mellitus, requiring at least 1 prescription medicine for management <br/ ><br>Documented chronic kidney disease with an estimated glomerular filtration rate lesser than 30 <br/ ><br>mL/min, not on dialysis <br/ ><br>Obesity Class 2 or 3 body mass index greater than 34.9 kg per m2) <br/ ><br>History of Chronic Kidney disease <br/ ><br>Oxygen saturation between 90 and 95% with or without supplemental oxygen <br/ ><br>Willing to cooperate with investigation team on study procedures including Radiographic <br/ ><br>assessments during the study period.→ | Exclusion criteria: Any of the following would exclude the subject from participation in the study: <br/ ><br>Subject or Authorized Representative is unable to provide informed consent <br/ ><br>Subject is pregnant or breastfeeding ladies <br/ ><br>Subject is of childbearing potential and has a positive pregnancy test since admission to <br/ ><br>the hospital <br/ ><br>Acute Respiratory Distress illness which is defined as the presence of critical signs and <br/ ><br>symptoms related with the COVID infection as per WHO criteria on severity at the time <br/ ><br>of enrollment <br/ ><br>History of receipt of blood transfusion or immunoglobulin products or expected receipt <br/ ><br>through the duration of the study <br/ ><br>Severe hepatic dysfunction like liver cirrhosis <br/ ><br>Clinically significant congenital anomaly of the respiratory tract <br/ ><br>Inability to take oral medication <br/ ><br>Prolonged QTc-interval in baseline ECG ( >500 ms) <br/ ><br>Severe renal failure characterized by chronic or acute need of hemodialysis, <br/ ><br>hemofiltration or peritoneal dialysis <br/ ><br>Participation in another research study involving an investigational agent within 30 days <br/ ><br>prior to consent <br/ ><br>Any condition that, in the opinion of the investigator, would interfere with evaluation of <br/ ><br>the investigational product or interpretation of subject safety or study results.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: ZingiVir H: An ayurvedic herbo mineral antiviral patented and proprietary drug. The antiviral dose is 6 tabs per day ( 500 mg tablets ) in divided doses - 6AM-9Am -12PM-3Pm-6PM-9PM. for a period of 10 to 15 days .<br>→ | Radiographic changes in lungs evaluated by Chest computed tomography scan <br/ ><br>Radiographic changes in brain evaluated by Brain computed tomography scanTimepoint: 0,15,30 days→ | | | | Yes | False | | |
| → | CTRI/2020/11/029035 | 27 January 2021 | Compare oxygen saturation from pulse oximetry and ABG in COVID-19 patients in ICU/HDU | An observational study of simultaneous pulse oximetry and arterial oxygen saturation readings in intensive care unit / high dependency unit in COVID -19 patients
| | Nadia Rose | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48696 | Recruiting | No | | | | 15-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ramya B Sriram→ | | Junior Resident
Dept.Of Anaesthesia
Rajarajeshwari Medical college and Hospital
Kambipura-560074 → | dr.nadia.rose@gmail.com→ | 9513454567→ | Rajarajeshwari Medical college and hospital→ | Inclusion criteria: Covid- 19 positive patients of age more than or equal to 18yrs and less than or equal to 80 years admitted to ICU/HDU→ | Exclusion criteria: Age less than 18yrs and more than 80yrs <br/ ><br>Diagnosis of methemoglobinemia <br/ ><br>Painted nails(nail polish) <br/ ><br>History of smoking <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | To examine the relationship between SpO2 (oxygen saturation as measured by pulse oximeter) and SaO2 (oxygen saturation measured by arterial blood gas analysis) measurements in COVID19 patients admitted to ICU/HDU. <br/ ><br>Timepoint: During ICU/HDU admission→ | | | | Yes | False | | |
| → | CTRI/2020/11/029004 | 27 January 2021 | RADIOLOGICAL AND LABORATORY TESTS CORELATION WITH CLINCIAL SEVERITY OF COVID19 | A STUDY TO CORRELATE RADIOLOGICAL FINDINGS AND LABORATORY MARKERS WITH CLINICAL SEVERITY IN COVID19 ILLNESS | | NA | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48969 | Not Recruiting | No | | | | 16-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Janakkumar R Khambholja→ | | Department of Medicine
First Floor, Sardar Vallabhbhai Patel Institute of Medical Science and Research (SVPIMSR)
Ellis Bridge
Ahmedabad Ellis Bridge
Ahmedabad→ | juhi1995patel@gmail.com→ | 8758390998→ | Smt NHL Municipal Medical College→ | Inclusion criteria: HOSPITALISED COVID-19 POSITIVE PATIENTS <br/ ><br>PATIENTE WITH AGE >18 YEARS→ | Exclusion criteria: PATIENTS NOT WILLING TO GIVE CONSENT→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Clinical DeteriorationTimepoint: At Baseline, Every 3rd Day till Discharge/Death→ | | | | Yes | False | | |
| → | CTRI/2020/11/029026 | 27 January 2021 | Long term lung problem of children who were affected by corona virus. | Assessment of long term respiratory sequelae in children who had infection with COVID 19 virus. - Nil | | FLUID RESEARCH GRANT | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49243 | Not Recruiting | No | | | | 16-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr P Madhan Kumar→ | | Child health unit 3
Christian Medical College
Vellore Ida scudder road
Vellore→ | dr_madhankumar@yahoo.com→ | 9600441010→ | Christian Medical College→ | Inclusion criteria: 1.All children between age group 4 â?? 15 years with COVID 19 positive getting admitted in CMC will be eligible to participate in the study.→ | Exclusion criteria: unwillingness to participate→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. To assess the respiratory sequelae of COVID 19 infection in children, by clinical examination and laboratory investigations during 1 year follow up period.Timepoint: 2 years→ | | | | Yes | False | | |
| → | CTRI/2020/11/029006 | 27 January 2021 | Survey of Knowledge, Attitudes and Practices towards Covid-19 Pandemic | Knowledge, Attitudes and Practices (KAP) towards Covid-19 Pandemic in Gynecologic oncology OPD: a cross-sectional survey - KAP | | NA | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49299 | Not Recruiting | No | | | | 20-11-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Pabashi Poddar→ | | Room No. 53, Gynecologic Oncology Service,Homi Bhabha Block, Tata Memorial Hospital,Parel, Mumbai → | pabashi@gmail.com→ | 0222417000→ | Tata Memorial Hospital→ | Inclusion criteria: 1.All patients and their relatives(maximum of two relatives per patient)aged 18 years and above who are attending GYN-DMG OPD at TMC and are willing to give consent to participate in this survey. <br/ ><br> <br/ ><br>2.The participants should be literate and be able to read, understand and answer in either â??Hindiâ?? or â??Englishâ?? or â??Marathiâ??→ | Exclusion criteria: 1.Patients or relatives not willing to participate in the survey <br/ ><br> <br/ ><br>2.Patients or relatives not attending GYN-DMG OPD at TMC <br/ ><br>→ | Health Condition 1: C51-C58- Malignant neoplasms of female genital organs
→ | Intervention1: Not Applicable: Not Applicable<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | To assess the Knowledge, Attitudes and Practices (KAP) regarding the Coronavirus Disease 2019 (COVID-19) pandemic among visitors to Gynecologic oncology-DMG (GYN-DMG) OPD (outpatient department) at Tata Memorial Centre.Timepoint: 2 months→ | | | | Yes | False | | |
| → | CTRI/2020/11/029029 | 27 January 2021 | A pilot study to determine health concerns developed during COVID-19 pandemic in childhood cancer survivors and siblings of Tata Memorial Hospital, who are now grown up adults. | Health Concerns in Adult Survivors of Childhood Cancer during COVID pandemic : A Pilot Survey | | Dr Maya Prasad | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48282 | Not Recruiting | No | | | | 12-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Maya Prasad→ | | Department of Medical Oncology-Pediatrics, Room no. 1101, Homi Bhabha Block, Tata Memorial Hospital, Dr. Ernst Borges Road. Parel, Mumbai- 400012 → | maya.prasad@gmail.com→ | 9819379113→ | Tata Memorial Hospital→ | Inclusion criteria: Inclusion Criteria for survivors: <br/ ><br>1. Adult (more than 18 years) survivors of childhood cancer registered in After Completion of Treatment Clinic <br/ ><br>2. Age more than 18 years at diagnosis, 5 years in remission <br/ ><br>3. Familiarity with English to be able to understand and respond to the survey <br/ ><br>4. Access to internet <br/ ><br> <br/ ><br>Inclusion criteria for Siblings : <br/ ><br>1. Sibling closest in age ( >18 years), and preferably same gender as the survivor <br/ ><br>2. Aware of the past history of survivor and current health and psycho-social issues <br/ ><br>3. Access to internet <br/ ><br>4. Familiarity with English to be able to understand and respond to the survey <br/ ><br> <br/ ><br>→ | Exclusion criteria: Exclusion criteria for Survivors: <br/ ><br>1. Neuro-cognitive problems or blindness <br/ ><br> <br/ ><br>Exclusion criteria for Siblings : <br/ ><br>1. Neurocognitive problems or blindness <br/ ><br>2. History of cancer diagnosis or treatment <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | To document the various health problems faced by adolescent and adult survivors of childhood cancer during the COVID pandemic.Timepoint: The survey will be administered once after establishing contact with the survivor/their sibling who has finished their treatment→ | | | | Yes | False | | |
| → | CTRI/2020/11/029008 | 27 January 2021 | To study the overall impact of consumption of non-alcoholic beverages on working from home adults, pre and during COVID times | Association between consumption of non-alcoholic beverages (pre and
during COVID times) and nutritional status, stress levels and work performance of working from
home adults 25-45 years | | Dr Meenakshi Garg | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49069 | Not Recruiting | No | | | | 20-11-2020 | 295 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dalia V R→ | | Department of Dietetics and Applied Nutrition,
Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal → | meenakshi.garg@manipal.edu→ | 9343163237→ | Welcomgroup Graduate School of Hotel Administration,MAHE→ | Inclusion criteria: Working from home adults willing to participate→ | Exclusion criteria: 1.Adults with chronic disorders/medical condition/co-morbidities such as diabetes, <br/ ><br>high blood pressure and heart related conditions. <br/ ><br>2.Adults with compromised immune system and critical medical conditions.→ | | | To study the association between the consumption of non-alcoholic beverages and nutritional status, stress levels and work performance from home working adults(25-45 yearsTimepoint: December 2020→ | | | | Yes | False | | |
| → | CTRI/2020/11/029007 | 27 January 2021 | Signs and symptoms and outcome of babies less than 28 days age admitted during pandemic in a only COVID-19 hospital in north India | Clinical Profile and Outcome of Neonates Admitted in a Dedicated Tertiary COVID -19 Facility in North India: A Retrospective and Prospective Observational Study | | Maulana Azad Medical College | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49326 | Not Recruiting | No | | | | 17-11-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ashish Jain→ | | Department of Neonatology Bahadur Shah Zafar Marg→ | ajayneonatology@gmail.com→ | 9968604310→ | Maulana Azad Medical College Delhi→ | Inclusion criteria: Neonates born to COVID-19 suspected or confirmed mothers and admitted in neonatal unit of the hospital.→ | Exclusion criteria: 1.Pregnancies with antenatal detected major foetal malformations. <br/ ><br>2.Concomitant viral infection-HIV, TORCH, hepatitis B in mother <br/ ><br>→ | Health Condition 1: P398- Other specified infections specific to the perinatal period
→ | | 1.Proportion of cesarean deliveries <br/ ><br>2.To determine the proportion of adverse perinatal outcomes among neonates cared at the dedicated COVID-19 Facility. <br/ ><br>3.To study the proportion of vertical transmission of SARS-COV2 defined by very early (within 24 hrs) RT PCR positivity or at birth among the neonates born to SARS-COV2 positive Mothers <br/ ><br>Timepoint: 28 days of age.→ | | | | Yes | False | | |
| → | CTRI/2020/11/029009 | 27 January 2021 | An online survey to compare the diet and physical activity management before and during COVID and how it is affected by education, occupation and income in people with diabetes belonging to middle and upper socioeconomic classes | Comparison of Management and Determinants of Type 2 Diabetes Mellitus before and during COVID-19 across middle and upper socio-economic strata- an online survey | | Dr Meenakshi Garg | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49077 | Not Recruiting | No | | | | 20-11-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Susan Maria→ | | Department of Dietetics and Applied Nutrition,
Welcomgroup Graduate School of Hotel Administration,MAHE, Manipal, Udupi,Karnataka 576104
→ | meenakshi.garg@manipal.edu→ | 9343163237→ | Welcomgroup Graduate School of Hotel Administration MAHE Manipal→ | Inclusion criteria: Adults with middle and upper socio-economic status willing to be part of the study. <br/ ><br>→ | Exclusion criteria: Patients with co morbid conditions such as Renal Disorders, Hepatitis, except Diabetes and Hypertension. <br/ ><br>Adults who are immunocompromised. <br/ ><br>Adults who are terminally ill. <br/ ><br>People who are below or above the age group of 20- 55 years. <br/ ><br>Adults who are illiterate <br/ ><br>→ | Health Condition 1: E119- Type 2 diabetes mellitus without complications
→ | | Difference in the dietary and lifestyle management of Type 2 DM across middle and upper wealth categories before and during COVID-19Timepoint: 5 Weeks and 6 days→ | | | | Yes | False | | |
| → | CTRI/2020/11/029012 | 27 January 2021 | To assess the impact of COVID-19 on the Diet, lifestyle and physical activity of IT employees (20-30 years) | Assessment and comparison of diet and lifestyle practices of IT professionals pre
and during COVID
| | Dr Meenakshi Garg | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49084 | Not Recruiting | No | | | | 20-11-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Koilakonda Sreebhavya→ | | Department of Dietetics and Applied Nutrition, Welcomgroup
Graduate School of Hotel Administration, MAHE. Madhav Nagar, Manipal.→ | meenakshi.garg@manipal.edu→ | 9343163237→ | Welcomgroup Graduate School of Hotel Administration, MAHE.→ | Inclusion criteria: People working as professionals in IT companies are included. <br/ ><br>Both males and females are included. <br/ ><br>Employees who are 20-30 years of age are included in the study.→ | Exclusion criteria: Employees above 30 years are excluded in the study. <br/ ><br>→ | | | To assess and compare diet pattern of IT professionals pre and during Covid-19.Timepoint: December 2020→ | | | | Yes | False | | |
| → | CTRI/2020/11/029032 | 27 January 2021 | Biological Eâ??s novel Covid-19 vaccine of SARS-CoV-2 for protection against Covid-19 disease. | A prospective open label randomised phase-I seamlessly followed by phase-II
study to assess the safety, reactogenicity and immunogenicity of Biological Eâ??s
novel Covid-19 vaccine containing Receptor Binding Domain of SARS-CoV-2 for
protection against Covid-19 disease when administered intramuscularly in a two
dose schedule (0, 28D) to healthy volunteers.
- None | | Biological ELimited | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48329 | Not Recruiting | No | | | | 16-11-2020 | 360 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 1/ Phase 2 | India→ | DrTSA Kishore→ | | Clinical affairs & Pharmacovigilance Dept, 2nd floor, Road No.35, Jubilee Hills
→ | subhash.thuluva@biologicale.com→ | 04071216248→ | Biological E.Limited→ | Inclusion criteria: 1.Ability and willingness to provide written or thumb printed informed consent prior to performing any study specific procedure. <br/ ><br>2.Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol. <br/ ><br>3.Participants of either gender between â?¥18 to â?¤55 years of age at phase-I and â?¥18 to â?¤65 years of age at phase-II at the time of 1st vaccination. <br/ ><br>4.Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR and anti-SARS-CoV-2 antibody prior to enrolment. <br/ ><br>5.Participants seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ ><br>6.Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital signs as defined in the protocol. [Normal vital signs defined as pulse rate of â?¥60 to â?¤100 bpm; blood pressure systolic of â?¥90 mm Hg and <140 mm Hg; diastolic â?¥ 60 mm Hg and <90 mm Hg; body temperature <100.4ºF prior to enrolment]. <br/ ><br>7.Female participants of child bearing potential negative to urine pregnancy test and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination; <br/ ><br>8.Agrees not to participate in another clinical trial at any time during the total study period. <br/ ><br>9.Agrees to refrain from blood donation during the course of the study. <br/ ><br>10.Agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ ><br>11.Willing to allow storage and future use of collected biological samples for future research in an anonymised form. <br/ ><br>→ | Exclusion criteria: 1.History of vaccination with any investigational vaccine against COVID-19 disease; <br/ ><br>2.Seropositive to IgG antibodies against SARS CoV-2 <br/ ><br>3.Living in the same household of any COVID-19 positive person; <br/ ><br>4.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during clinical trials; <br/ ><br>5.Seriously overweight (BMI â?¥ 40 Kg/m2); <br/ ><br>6.Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment; <br/ ><br>7.History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines); <br/ ><br>8.Current or planned participation in prophylactic drug trials for the duration of the study. <br/ ><br>9.Any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator; <br/ ><br>10.Body temperature of â?¥100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination; <br/ ><br>11.History of severe psychiatric conditions likely to affect participation in the study; <br/ ><br>12.History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder); <br/ ><br>13.History of allergic disease or reactions likely to be exacerbated by any component of the Biological Eâ??s four COVID-19 vaccine formulations; <br/ ><br>14.Chronic respiratory diseases, including asthma; <br/ ><br>15.Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness; <br/ ><br>16.Any other serious chronic illness requiring hospital specialist supervision; <br/ ><br>17.Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week for at least one year; <br/ ><br>18.Chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. For corticosteroids, this will mean prednisone â?¥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed; <br/ ><br>19.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required); <br/ ><br>20.Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ ><br>21.Individuals who are part of the study team or close family members of individuals conducting the study. <br/ ><br>→ | | Intervention1: Biological Eâ??s novel Covid-19 vaccine containing Receptor Binding Domain of SARS-CoV-2: With four formulations, BECOV2D, BECOV2C,BECOV2B and BECOV2A. Dose: 0.5ml, Route of administration:Intramuscular injection, Frequency: Two doses at Day 0 and Day 28.<br>Control Intervention1: None: None<br>→ | Phase-I <br/ ><br>1.any adverse reactions <br/ ><br>2.any solicited symptoms <br/ ><br>3.any unsolicited adverse events <br/ ><br>4.Serious and other medically attended adverse events <br/ ><br>Phase-II <br/ ><br>1.Virus neutralizing antibody (NAb) assay against SARS-CoV-2 virus <br/ ><br>2.Seroconversion rates in terms of proportion of subjects with â?¥4-fold increase in neutralizing antibodies <br/ ><br>3.Geometric mean titres and Geometric mean fold rise in neutralizing antibodies <br/ ><br>Timepoint: Phase-I <br/ ><br>1.within 2 hours of immediate post vaccination period; <br/ ><br>2.within 7 consecutive days after each dose captured through subject diary; <br/ ><br>3.at 6 months and 12 months post 2nd dose. <br/ ><br>4.at 6 months and 12 months post 2nd dose <br/ ><br> <br/ ><br>Phase-II <br/ ><br>1.at baseline, 28, 42, 56 days and again at 6 months and 12 months post 2nd dose. <br/ ><br>2.from baseline <br/ ><br>3.from baseline <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/11/029030 | 27 January 2021 | Multicentric observational study on Pediatric Multisystem Inflammatory Syndrome (PMIS) related to Covid-19 | Covid-19 associated Pediatric Multisystem Inflammatory syndrome (PMIS): A multicentric observational clinical study from Delhi | | Dr Dhiren Gupta | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48102 | Not Recruiting | No | | | | 19-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Bharat Mehra→ | | Department of Pediatrics, Max super-speciality hospital, FC 50, C and D Block, Shalimar Place Site, Shalimar Bagh, New Delhi, Delhi → | bharatmehra909@gmail.com→ | 9999538720→ | Max super-speciality hospital, Shalimar Bagh→ | Inclusion criteria: 1. Fever > 38â??C for â?¥24 hours in last 7 days <br/ ><br>2. Evidence of clinically severe hospitalized illness among children aged <18 years with multisystem (â?¥2) organ involvement <br/ ><br>(cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic or neurological) see table for definitions used for organ involvement. <br/ ><br>3. Elevated markers of inflammation (eg, neutrophilia; lymphopenia; hypoalbuminemia; and elevated levels of C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fibrinogen, procalcitonin, d-dimer, ferritin, lactic acid dehydrogenase (LDH), or interleukin 6 (IL-6)] <br/ ><br>4. No other obvious microbial cause of inflammation, including bacterial sepsis and staphylococcal/streptococcal toxic shock syndromes <br/ ><br>5. Evidence of SARS-CoV-2 infection (Any of the following): <br/ ><br>5.1. Positive SARS-CoV-2 RT-PCR <br/ ><br>5.2. Positive serology <br/ ><br>5.3. Positive antigen test <br/ ><br>5.4. Negative for SARS-CoV-2 RT-PCR and antibody tests but with identified COVID-19 exposure within the four weeks prior to the onset of symptoms→ | Exclusion criteria: 1. Hospital stay < 24 hours <br/ ><br>2. Presence of other obvious microbiological cause of inflammation/ clinical condition <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | MortalityTimepoint: At the time of discharge from hospital→ | | | | Yes | False | | |
| → | CTRI/2020/11/029036 | 27 January 2021 | A study to identify the rehabilitation need in post-discharge COVID-19 survivors | A cross-sectional observational study to identify the rehabilitation need in post-discharge COVID-19 survivors - ReCOVer study | | Raktim Swarnakar | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46058 | Not Recruiting | No | | | | 16-11-2020 | 384 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Raktim Swarnakar→ | | Department of Physical Medicine and Rehabilitation (PMR), All India Institute of Medical Sciences (AIIMS), New Delhi → | slyaiims@yahoo.co.in→ | 9560678577→ | Department of Physical Medicine and Rehabilitation (PMR), AIIMS, New Delhi→ | Inclusion criteria: 1.Age: age group ( more than or equal to 18 years) <br/ ><br>2.Either gender. <br/ ><br>3.Post-discharge (minimum 1 week) of any confirmed COVID-19 cases those who required hospitalization (required oxygenation, ICU monitoring or management, etc. for COVID-19).→ | Exclusion criteria: 1.No access to or unavailability of minimum phone-calling facility. <br/ ><br>2.Not willing to participate in the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. ICF core data set <br/ ><br>Timepoint: post-discharge (after minimum one week)→ | | | | Yes | False | | |
| → | CTRI/2020/11/029037 | 27 January 2021 | The performance of a novel ultra-rapid diagnostic test in the detection of COVID 19, an observational and case controlled study. | A Pivotal Study of ASU CV19
In COVID-19 Positive Patients and Healthy Subjects
| | Canary Health Technologies | 10-11-2020 | 20201110 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48368 | Not Recruiting | No | | | | 18-11-2020 | 750 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Prof Ashok Rattan→ | | A298/13th floor Okhla Phase 1 Industrial area New Delhi 110020 → | drashokrattan@gmail.com→ | 9560272576→ | Divoc Laboratories→ | Inclusion criteria: Participant is willing and able to give informed consent for participation in the study. <br/ ><br>Male or Female, Adult over the age of 18 <br/ ><br>No smoking, eating or alcohol for 4 hours prior to test <br/ ><br>Either COVID-19 Positive or COVID-19 Negative <br/ ><br>No perfume/cologne or heavy scent <br/ ><br>Subject who is able to comply with the study requirements, as defined in the present protocol, at the Investigatorâ??s discretion <br/ ><br>Able (in the Investigators opinion) and willing to comply with all study requirements. <br/ ><br>Diagnosed with required disease/severity/symptoms, or, if healthy volunteer study: beingood health <br/ ><br>→ | Exclusion criteria: Age <14 <br/ ><br>Any serious injury or illness likely to preclude completion of the trial. <br/ ><br>Frequent alcohol or recreational drug use. <br/ ><br>Hospitalized. <br/ ><br>Undergoing active chemotherapy. <br/ ><br>Fever in uninfected controls. <br/ ><br>Hypoxia, defined as pulse oximetry lower than 92% (90% in smokers and those with <br/ ><br>chronic lung disease). <br/ ><br>Respiratory disease such as COPD and Asthma. <br/ ><br>Currently taking any corticosteroid treatment including but not limited to oral and inhaled <br/ ><br>corticosteroid (within 4 weeks of trial). <br/ ><br>Inability to give informed consent and/or has no guardian. <br/ ><br>Flu shot within 6-8 weeks of test. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ASU Device: Patient breathes into device by<br>themselves after instruction by research assistant with regular respirations over a minimum 3-5<br>minutes providing approximately 60-100 respirations across the sensor array depending on health<br>status.<br>→ | To collect breath sample from uninfected subjects and those diagnosed with COVID 19 and compare the VOC pattern in each group to develop an algorithm for analysisTimepoint: At the end of the Study→ | | | | Yes | False | | |
| → | CTRI/2020/11/029060 | 27 January 2021 | High chloride level, anaemia and severity of COVID-19 | Incidence of hyperchloremia and its association with anaemia and inflammatory markers in non-bleeding COVID-19 patients in intensive care unit- a cross-sectional prospective observational study. | | Vedaghosh Amara | 11-11-2020 | 20201111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49411 | Not Recruiting | No | | | | 21-12-2020 | 60 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Vedaghosh Amara→ | | Department of Critical Care Medicine
Kasturba Medical College and Hospital
Madhav Nagar, Manipal, Karnataka
→ | vedaghosh@gmail.com→ | 0829-2922033→ | Kasturba Medical College and Hospital.→ | Inclusion criteria: Patients aged 18-80 years admitted to critical care unit and on oxygen support with either invasive ventilation/Non- invasive ventilation ( NIV) / high flow nasal cannula (HFNC) /non rebreathing mask (NRBM) /venturi devices as deemed suitable by ICU consultant→ | Exclusion criteria: No evidence of bleeding in any <br/ ><br>Patients with preexisting disorders causing hyperchloraemia like severe diarrhea <br/ ><br>Chronic or acute kidney disease (GFR <15mL/min) <br/ ><br>Any patient on dialysis. <br/ ><br>Extremely high ingestion of salt water and high ingestion of dietary salt. <br/ ><br>Use of drugs like carbonic anhydrase inhibitors <br/ ><br>Confounding factors of raised CRP like burns, trauma, tuberculosis, myocardial infarction, chronic inflammatory disorders like lupus, vasculitis or rheumatoid arthritis, inflammatory bowel disease and certain cancers. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | | Chloride level,CRP,Ferritin ,Haemoglobin.Timepoint: Day 3 of ICU admission.→ | | | | Yes | False | | |
| → | CTRI/2020/11/029059 | 27 January 2021 | Blood Glucose Management in Diabetic COVID19 Patients | TO STUDY ASSOCIATION OF BLOOD GLUCOSE CONTROL AND OUTCOME OF COVID 19 ILLNESS IN DIABETIC PATIENTS | | NA | 11-11-2020 | 20201111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48971 | Not Recruiting | No | | | | 20-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Janakkumar R Khambholja→ | | Department of Medicine
First Floor
Sardar Vallabhbhai Patel Institute of Medical Science and Research (SVPIMSR) Ellis Bridge
Ahmedabad→ | patelsuhag9090@gmail.com→ | 7621886071→ | Smt NHL Municipal Medical College→ | Inclusion criteria: 1. Inpatients in General Medicine with diagnosis of COVID 19 infection (Laboratory confirmed) <br/ ><br>2. Patients with pre existing diabetes or New onset diabetic patients. <br/ ><br>→ | Exclusion criteria: 1. AGE Less than 18 YEARS <br/ ><br>2. Acute Myocardial infarction <br/ ><br>3. Acute cerebral vascular stroke <br/ ><br>4. Pregnant Female <br/ ><br>5. Impaired glucose tolerance→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Clinical Deterioration and Control of Blood GlucoseTimepoint: At Baseline, Every 3rd Day till Discharge/Death→ | | | | Yes | False | | |
| → | CTRI/2020/11/029040 | 27 January 2021 | Effect of corona virus disease on the mental state of anesthesiologists in India | Impact of Covid-19 pandemic on the mental health of anesthesiologist in India | | Government Medical college and hospital | 11-11-2020 | 20201111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44640 | Not Recruiting | No | | | | 15-11-2020 | 383 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | N/A | India→ | Dr Sanjeev Palta→ | | 5th floor , Block D
Department of Anaesthesia and Intensive Care, Government Medical College and Hospital,Sector - 32, Chandigarh
Chandigarh
→ | kompaljain3.kj@icloud.com→ | 08289037336→ | Government Medical College and Hospital, Chandigarh→ | Inclusion criteria: All the anesthesiologist who will give informed consent by filling the <br/ ><br>form completely will be included in the study.→ | Exclusion criteria: The anesthesiologist who will not give informed consent and will not <br/ ><br>respond back with completely filled forms within 20 days of distribution will be excluded from the study.→ | | | Prevalence of mental health issues among anesthesiologists due to impact of Covid-19 pandemic using an online surveyTimepoint: 4 months of covid pandemic→ | | | | Yes | False | | |
| → | CTRI/2020/11/029038 | 27 January 2021 | Can combination of Haldi, Pomegranate and Zinger extract tablets help in reducing duration of hospital stay of mild to moderate COVID-19 patients. | Role of Dantabija, Haridra and Zingiber officinale in halting progression and reducing duration of mild to moderate COVID-19 disease | | Alchem Phytoceuticals | 11-11-2020 | 20201111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48233 | Not Recruiting | No | | | | 19-10-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Yogesh Kumar→ | | Department of Physiology
All India Institute of Medical Sciences Patna, Phulwarisharif, Patna → | dryogeshk@aiimspatna.org→ | 7759835573→ | AIIMS Patna→ | Inclusion criteria: a)COVID-19 RT-PCR test/ COVID-19 antigen test/COVID-19 TRUNAT test Positive <br/ ><br>b) All Males and Females between 5 to 70 years. <br/ ><br>c) Having history of dry cough/fever/malaise/rhinorrhea/New loss of taste and smell/Gastrointestinal upset. <br/ ><br>d) Patients who can take medicines orally. <br/ ><br>e) No Oxygen requirement/ Oxygen requirement of less than 5L/minute.→ | Exclusion criteria: a) Oxygen requirement of more than 5L/minute. <br/ ><br>b) Patients who are on Ventilatory support. <br/ ><br>c) Who cannot take medicines by oral route? <br/ ><br>d) Patients who are on dialysis. <br/ ><br>e) Age less than five years and more than 70 years. <br/ ><br>f) Patients taking any other Ayurvedic supplement.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Dantabija, Haridra and Zingiber officinale Lozenges: Intervention group will recieve standard treatment plus chewable tablets containing ginger, turmeric and pomegranate extracts (Dantabija 20mg + Haridra 50mg + Zingiber officinale 5mg) in a dose of 3 tablets/day for 10 days.<br>This drug is already available in market.<br>Control Intervention1: Paracetamol, Zinc and Vitamin C, Azithromycin, Low molecular weight heparin, Hydroxychloquine, Methyl Prednisolone: For mild cases:-<br>Antipyretic (Paracetamol) for fever and pain if complain of fever.<br>Adequate nutrition and appropriate rehydration. <br>Supplements like zinc and vitamin C, and <br>Tab Azithromycin 500mg OD, if there is symptoms of upper respiratory tract infection. <br>For moderate disease:- All above and<br>Oxygen Support: <br>All patients should have daily 12-lead ECG <br>Follow CRP, & Ferritin every 48-72 hourly, CBC with differential count, Absolute Lymphocyte count, KFT/LFT daily <br>Tab. Hydroxychloroquine (400mg) BD on 1st day followed by 200mg 1 BD for 4 days. (after ECG Assessment) <br>IV methylprednisolone 0.5 to 1 mg/kg for 3 days (preferably within 48 hours of admission or if oxygen requirement is increasing and if inflammatory markers are increased) <br>Anticoagulation <br>Prophylactic dose of UFH or LMWH (e.g., enoxaparin 40 mg per day SC)<br>→ | To Evaluate efficacy of combination of Dantabija 20mg, Haridra 50mg and Zingiber officinale 5mg in controlling COVID-19 Disease <br/ ><br>We will measure following parameters <br/ ><br>1)COVID-19 RT PCR test <br/ ><br>2) Complete Blood Count <br/ ><br>3)C reactive protein and serum Ferritin <br/ ><br>4)IL-2 and IL-6. <br/ ><br>Timepoint: 5th Day and 10th day from start of Intervention→ | | | | Yes | False | | |
| → | CTRI/2020/11/029041 | 27 January 2021 | A study to assess the overall dietary practices among young and middle-aged adults pre and during COVID times | Use of Food Consumption Score and Dietary Diversity Score as indicators to compare the nutritional status, dietary diversity, and potential risk of micro-nutrient deficiencies among young and middle-aged adults, pre and during COVID times | | Dr Meenakshi Garg | 11-11-2020 | 20201111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49076 | Not Recruiting | No | | | | 20-11-2020 | 317 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Kritthika Gonella→ | | Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal, Udupi, Karnataka
576104 → | meenakshi.garg@manipal.edu→ | 9343163237→ | Welcomgroup Graduate School of Hotel Administration→ | Inclusion criteria: Young and middle aged adults→ | Exclusion criteria: 1. Adults who are bedridden and/or are undergoing hospital treatment for any severe comorbidities <br/ ><br>2. Pregnant and lactating women→ | | | Impact of COVID-19 pandemic on the Dietary Diversity Scores and household food security among young and middle-aged adultsTimepoint: December 2020→ | | | | Yes | False | | |
| → | CTRI/2020/11/029042 | 27 January 2021 | Measurement of nutritional and health status of Beedi workers before and during COVID times. | Assessment of nutritional and health status of Beedi workers pre and during COVID times
| | Dr Meenakshi Garg | 11-11-2020 | 20201111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49098 | Not Recruiting | No | | | | 20-11-2020 | 160 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Nithin→ | | Department of Dietetics and Applied Nutrition Welcomgroup Graduate School of Hotel Administration,Madhav nagar, MAHE, Manipal,Udupi, Karnataka 576104
→ | Meenakshi.garg@manipal.edu→ | 9343163237→ | Welcomgroup Graduate School of Hotel Administration MAHE Manipal→ | Inclusion criteria: Beedi workers of Udupi district who are willing to be a part of study <br/ ><br>Adult Men and Women whose age is between 18 to 65 years→ | Exclusion criteria: Pregnant and lactating females <br/ ><br>Children below 18 years <br/ ><br>Men and women whose age is more than 65 years.→ | | | Impact of COVID-19 on the health and nutritional status of Beedi workers pre and during COVID timesTimepoint: December 2020→ | | | | Yes | False | | |
| → | CTRI/2020/11/029061 | 27 January 2021 | Multisystemic inflammatory syndrome in children (MIS-C) in COVID pandemic | Clinical profile and outcome of Multisystemic inflammatory syndrome in children (MIS-C) in COVID pandemic â?? An observational study from a paediatric tertiary care centre - MIS-C | | ICH HC Madras Medical College Chennai | 11-11-2020 | 20201111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49371 | Recruiting | No | | | | 29-11-2020 | 200 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr V Poovazhagi→ | | Institute of Child health,
Madras Medical College,
Chennai Bhanumati, Rina Mandal Rd, Egmore, Chennai, Tamil Nadu 600008→ | elil.raghu@gmail.com→ | | Institute of Child health,→ | Inclusion criteria: Children admitted to PICU with MIS-C→ | Exclusion criteria: Non MIS-C Children→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To identify the different phenotypes of MIS-C. spectrum <br/ ><br> Time forn ormalisation of clinical symptoms of fever and rash <br/ ><br> Time for normalization of lab abnormalities of inflammatory markers ESR CRP <br/ ><br>Timepoint: 3, 6, 9 ,12 months→ | | | | Yes | False | | |
| → | CTRI/2020/11/029058 | 27 January 2021 | Study to assess the impact of COVID 19 infection on pulmonary function tests in children | Cross sectional study to assess the impact of COVID 19 infection on pulmonary function tests in children | | Not applicable | 11-11-2020 | 20201111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49392 | Not Recruiting | No | | | | 20-11-2020 | 100 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Romit Saxena→ | | Department of Pediatrics, Maulana Azad Medical college and associated Lok Nayak Hospital , Bahadur Shah Zafar Marg, New Delhi Maulana Azad Medical college and associated Lok Nayak Hospital , Bahadur Shah Zafar Marg, New Delhi→ | drromit@gmail.com→ | | Maulana Azad Medical college→ | Inclusion criteria: 1. Any patient who was admitted as an in-patient in Department of Pediatrics between March , 2020 â?? September 2020 <br/ ><br>2. At least 15 days from the date of discharge. <br/ ><br>3. Admitted with confirmed diagnosis of COVID 19 <br/ ><br>4. Resides in Delhi state and agrees to commute to get spirometry on telephonic conversation <br/ ><br>5. Consent for spirometry and taking part in the study <br/ ><br>6. 8-18 years of age so that can undertake spirometry.→ | Exclusion criteria: 1. No underlying lung disease. <br/ ><br>2. No pre-existing diagnosis of asthma. <br/ ><br>3. No congenital lung abnormalities→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Pulmonary function testing: Spirometry will be done as per protocol, to ascertain pulmonary function tests of the child, meeting inclusion and exclusion criterion.<br>Control Intervention1: Not applicable: Not applicable<br>→ | To analyze the residual impact of COVID 19 disease on pulmonary function tests in pediatric patients(8-18 years of age) as assessed by pulmonary function tests.Timepoint: Cross sectional study , for pediatric patients admitted between , March , 2020 â?? September 2020. Patients, will be called once, for pulmonary function testing , as per appointments available and assessed for impairment of lung function (if any ) . The study is proposed to be held between November, 2020 -January , 2021→ | | | | Yes | False | | |
| → | CTRI/2020/11/029063 | 27 January 2021 | To study the effect of povidone iodine gargle and nasal drops on disease transmissibility in SARS-CoV-2 infected patients | Effect of 0.5% Povidone Iodine on the Oropharyngeal/Nasopharyngeal Samples Of COVID-19 Patients: A Double-Blind Placebo-Controlled Randomized Controlled Trial. | | Uttar Pradesh University Of Medical Sciences | 12-11-2020 | 20201112 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48939 | Not Recruiting | No | | | | 12-11-2020 | 32 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Dr Pranav Sharma→ | | Room No. 113, Department of Orthopaedics, Trauma Centre, Uttar Pradesh University Of Medical Sciences, Saifai, Etawah → | nareshpalsingh@gmail.com→ | 9458641119→ | Uttar Pradesh University of Medical Sciences→ | Inclusion criteria: 1. Patients infected with SARS-CoV-2 on the day one of admission before administration of any routine treatment. <br/ ><br> <br/ ><br>2. Patientsâ?? age should be 18 years and above at the time of enrollment, considering he/she can provide informed legal consent. <br/ ><br> <br/ ><br>3. Patients presented with mild to moderate COVID-19 illness. <br/ ><br> <br/ ><br>4. Patients presented to the hospital within 10 days of symptom onset.→ | Exclusion criteria: 1. Patients infected with SARS-CoV-2 admitted in the hospital for more than one day and on routine treatment for COVID-19. <br/ ><br> <br/ ><br>2. Any patient who has severe illness debilitating the patient to provide consent as well as adopt the study procedure. <br/ ><br> <br/ ><br>3. Patients less than 18 years of age at the time of enrollment. <br/ ><br> <br/ ><br>4. Patients already using oral/intra-nasal antiseptic. <br/ ><br> <br/ ><br>5. Any patient with known thyroid disorders. <br/ ><br> <br/ ><br>6. Pregnant and lactating women. <br/ ><br> <br/ ><br>7. Patients who disagree to consent. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Povidone - Iodine (PVP-I) solution: 0.5% Povidone â?? Iodine (PVP-I) solution freshly prepared by dilution of commercially available 5% PVP-I solution, in the form of nasal drops and gargles.The subjects in interventional arm of this RCT will receive freshly diluted 0.5% PVP-I solution in the form of 2-3 self-administered nasal drops in each nostril followed by 20 ml 0.5% PVP-I solution for gargling for a duration of 30 seconds.<br>Control Intervention1: Normal Saline (Placebo): The subjects in control arm of this RCT will receive commercially available 0.9 % solution of sodium chloride (normal saline) in the form of 2-3 self-administered nasal drops in each nostril followed by 20 ml normal saline solution for gargling for a duration of 30 seconds.<br>→ | To estimate the change in the viral load and Ct value in the oropharyngeal/nasopharyngeal samples of the patients infected with SARS-CoV-2.Timepoint: 5 minutes, 3 hours and 6 hours of administration of interventional agents→ | | | | Yes | False | | |
| → | CTRI/2020/11/029067 | 27 January 2021 | A study to look out outcomes of treated COVID-19 patients admitted to a private hospital in Bangalore | A retrospective study of presentation, treatment and outcome of COVID-19 patients admitted to a private hospital in Bangalore | | ColumbiaAsia Hospital | 12-11-2020 | 20201112 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47660 | Not Recruiting | No | | | | 15-11-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Girish Namagondlu→ | | Room No.12
Department of Nephrology
Kirloskar Business Park
Bellary Road, Hebbal
Bangalore → | girishnamagondlu@gmail.com→ | 9880825431→ | ColumbiaAsia Hospital, Hebbal→ | Inclusion criteria: COVID positive patients admitted from June 2020 to sep2020→ | Exclusion criteria: age <18yrs <br/ ><br>covid positive outpatiens→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B998- Other infectious disease
→ | | The Recovery and fatality rates of treated COVID admissions at our centre <br/ ><br>Timepoint: Baseline and at 4 weeks <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/11/029068 | 27 January 2021 | study of heart injury by laboratory investigation in corona positive patients. | Co-relation of biochemical cardiac markers of cardiac injury with clinical outcome of COVID 19 patients with or without preexisting cardiac illness. | | Dr Vijaysinh Parmar | 12-11-2020 | 20201112 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48973 | Not Recruiting | No | | | | 17-11-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Vijaysinh Parmar→ | | Department of biochemistry smt NHL Municipal Medical College Ellisbridge Ahmedabad 380006 → | drvijaysinhparmar@gmail.com→ | 9909429619→ | smt NHL Municipal Medical College→ | Inclusion criteria: Patients admitted in SVP Hospital <br/ ><br>Positive realâ??time polymerase chain reaction (RTâ??PCR) assay from nasoâ??pharyngeal and oral swab specimens <br/ ><br>Patients having complete clinical data <br/ ><br>→ | Exclusion criteria: Incomplete clinical data <br/ ><br>Clotted samples <br/ ><br>Lipemic samples <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | To check myocardial injury by analysis of cardiac biomarker level in covid 19 patientsTimepoint: At baseline and 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/11/029070 | 27 January 2021 | To study the Influence of Food habits, Physical activity and knowledge of pregnant mothers on the problems faced in pregnancy, type of delivery and Birth weight of newborn during COVID-19 times. | â??Impact of Maternal Nutrition, Lifestyle and Knowledge on Discomforts/Complications during Pregnancy and Birth Outcomes during COVID-19 Pandemic.â?? | | Dr Meenakshi Garg | 12-11-2020 | 20201112 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49261 | Not Recruiting | No | | | | 20-11-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rasmiya→ | | Department of Dietetics and Applied Nutrition,
Welcomgroup Graduate School of Hotel Administration, Madhav Nagar, Manipal. → | meenakshi.garg@manipal.edu→ | 9343163237→ | Welcomgroup Graduate School of Hotel Administration, MAHE→ | Inclusion criteria: Pregnant women who are in their 2nd or 3rd trimester and who have delivered in the last one month prior to the date of commencement of data collection will be selected for the study. Pregnant women who are willing to be a part of the study. <br/ ><br>Pregnant women from any socio-economic background will be selected. <br/ ><br>Those who are literates will be considered in the study. <br/ ><br>→ | Exclusion criteria: Women who have serious health complications in pregnancy will not be selected in the study. <br/ ><br>Pregnant women who are mentally disabled or those who have fetal abnormalities will not be selected. <br/ ><br>Women who are below 18 years with unplanned pregnancy will not be encouraged to involve in the study. <br/ ><br>Women who finds difficulty in reading and writing will be excluded from this study <br/ ><br>→ | Health Condition 1: O94- Sequelae of complication of pregnancy, childbirth, and the puerperium
→ | | To study the association between maternal nutrition, lifestyle on discomforts/complications of pregnant women during COVID-19 Pandemic.Timepoint: December 2020→ | | | | Yes | False | | |
| → | CTRI/2020/11/029084 | 27 January 2021 | Covid-19 risk factors among health care workers | Risk factors for COVID-19 among health care workers | | Dr Cynthia Amrutha Sukumar | 12-11-2020 | 20201112 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49352 | Not Recruiting | No | | | | 21-11-2020 | 172 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Cynthia Amrutha Sukumar→ | | Dept. of Medicine, Kasturba Medical College → | cynthiaamrutha@gmail.com→ | 7259415415→ | Manipal academy of higher education→ | Inclusion criteria: health care workers with direct exposure to patients having confirmed covid-19 infection→ | Exclusion criteria: Refusal to give consent→ | | Control Intervention1: Covid infection: Details of health care worker with exposure to covid<br>→ | To assess risk factors for covid among health care workersTimepoint: November to December 2020→ | | | | Yes | False | | |
| → | CTRI/2020/11/029124 | 27 January 2021 | Effect of COVID-19 on exercise pattern, diet pattern and weight change in athletes | Impact of COVID-19 on exercise regimen , diet regimen and weight change in athletes | | Rachana | 13-11-2020 | 20201113 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49435 | Not Recruiting | No | | | | 21-11-2020 | 336 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Swathi Acharya→ | | Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal → | swathi.acharya@manipal.edu→ | 9535071393→ | Welcomgroup Graduate School of Hotel Administration, MAHE, Manipal→ | Inclusion criteria: Athletes who practices minimum one hour of sports every day and athletes with minimum one year of being in to sports activity. And athletes between the age group of 18 to 30 in spite of any gender.→ | Exclusion criteria: Athletes below and above the age of 18 and 30 respectively and athletes with health issues such as Diabetes Mellitus and the participants who are not willing to participate in the study are excluded from the study.→ | | | assess the change that has happened in the exercise or practice regimen of the athletes due to covid-19.Timepoint: Single interaction→ | | | | Yes | False | | |
| → | CTRI/2020/11/029130 | 27 January 2021 | The lying in prone position effect on oxygen saturation in patients in early stage and not intubated having mild to moderate Lung Disease with COVID-19 | The effect on oxygen saturation in Early self-proning in awake, non-intubated patients with mild to moderate ARDS COVID-19 | | AIIMS Patna | 16-11-2020 | 20201116 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49155 | Not Recruiting | No | | | | 16-11-2020 | 48 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shagufta Naaz→ | | Associate professor, department of Anaesthesiology, AIIMS Patna, Phulwarisharif Patna 801507 → | drshaguftanaaz@gmail.com→ | 07765937919→ | AIIMS Patna→ | Inclusion criteria: 1. COVID-19 induced mild to moderate ARDS <br/ ><br>2. Onset within one week of COVID-19 <br/ ><br>3. SpO2/FiO2 140-315 <br/ ><br>4. PF Ratio 100-300 mmHg <br/ ><br>5. Bilateral changes on chest imaging <br/ ><br>6. Not fully explained by cardiac failure <br/ ><br>7. Patients between the ages of 18-75 years <br/ ><br>8. Male and female <br/ ><br>9. BMI 18-30kg/m2 <br/ ><br>10. Oxyhemoglobin saturation (SpO2) â?¤94% while receiving supplemental oxygen 6 L/min via nasal cannula and 15 L/min via non-rebreather facemask or with FiO2 0.3-0.6 (If HFNC or NIV) <br/ ><br>→ | Exclusion criteria: 1 Need for immediate intubation <br/ ><br>2 RR >40 <br/ ><br>3 PaO2/FiO2 <100 <br/ ><br>4 SpO2/FiO2 <140 <br/ ><br>5 Obvious accessory muscle use <br/ ><br>6 HR >100 <br/ ><br>7 Systolic BP <100 mm Hg <br/ ><br>8 Unable/unwilling to participate to trial <br/ ><br>9 Unreliable SpO2 Trace <br/ ><br>10 Pregnancy >20/40 gestation <br/ ><br>11 Altered mental status with inability to turn in bed without assistance <br/ ><br>12 Multi-organ failure <br/ ><br>13 Contraindication to PP (e.g. vomiting, abdominal wound, unstable pelvic/spinal lesions, severe brain injury). <br/ ><br>14 Unable to maintain prone position <br/ ><br>→ | Health Condition 1: J80- Acute respiratory distress syndrome
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Prone positionioning: Patient will be asked to lie in prone position for a minimum of three hours in a day and maximum as much as and as many time as he can the patient can tolerate. Those who are not able to do so will be excluded.<br>→ | Primary outcome will be the change in oxygenation (arterial partial pressure of oxygen [PaO2]/FiO2 ratio) ratio as an index of pulmonary recruitment 1 hour after initiation of the prone position.Timepoint: Primary outcome will be the change in oxygenation (arterial partial pressure of oxygen [PaO2]/FiO2 ratio) ratio as an index of pulmonary recruitment 1 hour after initiation of the prone position.→ | | | | Yes | False | | |
| → | CTRI/2020/11/029143 | 27 January 2021 | Impact of COVID 19 on Guillain-Barré Syndrome in India | Impact of COVID 19 on the frequency, spectrum and outcomes of Guillain-Barré Syndrome in India: A Multicenter ambispective cohort study | | AIIMS New delhi | 16-11-2020 | 20201116 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47626 | Not Recruiting | No | | | | 01-12-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Vishnu VY→ | | RN 704
Seventh floor
CN Centre
AIIMS New Delhi → | vishnuvy16@yahoo.com→ | 9855480361→ | AIIMS New Delhi→ | Inclusion criteria: 1. Diagnosis of GBS confirmed by diagnostic criteria for GBS of the National Institute of Neurological Disorders and Stroke (NINDS) or one of the variants of GBS, including the MFS and overlap syndromes <br/ ><br>2. Hospital admission within 4 - weeks of the onset of weakness (or other symptoms attributed to GBS. <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Subacute Inflammatory demyelinating neuropathy (SIDP) <br/ ><br>2. Toxic neuropathies <br/ ><br>3. Vasculitic neuropathies <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: G610- Guillain-Barre syndrome
→ | | Proportion of patients with GBS admitted during COVID pandemic compared to similar period in the previous yearTimepoint: 7 months→ | | | | Yes | False | | |
| → | CTRI/2020/11/029142 | 27 January 2021 | Effect of COVID19 work from home on musculoskeletal disorders. | Effect of COVID19 lockdown/ compulsive work from home (WFH) situation on musculoskeletal disorders. | | Manipal Academy of Higher Education | 16-11-2020 | 20201116 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49439 | Not Recruiting | No | | | | 01-12-2020 | 498 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Garima Gupta→ | | Department of Physiotherapy Center for Diabetic Foot care and Research
MCHP
MAHE
MANIPAL
→ | arun.maiya@manipal.edu→ | | Manipal College of Health Profession→ | Inclusion criteria: Working/employed/ self-employed challenged/ forced to work from home due to COVID19 pandemic. <br/ ><br>Workplace India <br/ ><br>Able to read and understand English <br/ ><br>→ | Exclusion criteria: Diagnosed case of cardiovascular or neurological disorder <br/ ><br>Aged below 18 or above 60 years <br/ ><br>→ | | Intervention1: NOT APPLICABLE: NO INTERVENTION WILL BE GIVEN<br>Control Intervention1: NOT APPLICABLE: NO COMPARISON WILL BE DONE<br>→ | Musculoskeletal discomfort/ pain at 12 different body regionsTimepoint: One time point→ | | | | Yes | False | | |
| → | CTRI/2020/11/029141 | 27 January 2021 | Sero-surveillance for Dengue, Chikungunya and COVID | Establish serial sero-surveillance to monitor the trend of SARS-CoV-2, Dengue and Chikungunya infection transmission in the general population, India | | Shikha Dixit | 16-11-2020 | 20201116 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49486 | Not Recruiting | No | | | | 01-12-2020 | 5000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Divya Nair→ | | THE INCLEN TRUST INTERNATIONAL, F-1/5, SECOND FLOOR, OKHLA INDUSTRIAL AREA PHASE 1. → | divya.nair@inclentrust.org→ | 8056748342→ | The INCLEN Trust International→ | Inclusion criteria: Survey will be carried out in individuals above 2 years of age (no upper limit on age) and all individuals currently residing and likely to stay till the end of study (1 year) in the study area will be considered eligible for inclusion.→ | Exclusion criteria: Individuals who are unlikely to stay in the study area for the next 1 year→ | | | Primary objectives <br/ ><br>I. Estimate the sero-prevalence of SARS-CoV-2 infection in the general population <br/ ><br>II. Estimate the 4 monthly incidence of SARS-CoV-2 infection based on serial sero-surveys <br/ ><br>III. Estimate cumulative sero-conversion of SARS-CoV-2 infection over one year period <br/ ><br>IV. Estimate the sero-prevalence and annual sero conversion of Dengue and Chikungunya in a sub sample of the studyTimepoint: Sero-prevalence of COVID will be assessed at baseline, 4 months, 8 months and 12 months→ | | | | Yes | False | | |
| → | CTRI/2020/11/029144 | 27 January 2021 | Effect of work from home on stress level and nutritional status of IT professionals during COVID-19 pandemic | Work from Home and its impact on Stress level and Nutritional Status of IT professionals during COVID-19 pandemic | | Bhargavi Bhaskar Hegde and Sakshi Srivastava and Sunanda Banerjee | 16-11-2020 | 20201116 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49306 | Not Recruiting | No | | | | 20-11-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Swathi Acharya K→ | | Department of Dietetics and Applied Nutrition
Welcomgroup Graduate School of Hotel Administration
Manipal Academy of Higher Education
Manipal → | swathi.acharya@manipal.edu→ | 9535071393→ | Welcomegroup Graduate School of Hotel Administration, Manipal→ | Inclusion criteria: 1. Male & female of age group 23-50years <br/ ><br>2. Subjects who are doing work from home for IT companies <br/ ><br>→ | Exclusion criteria: 1. Male & female of age group below 23years and above 50years <br/ ><br>2. Who are not doing work from home for IT companies <br/ ><br>3. Who are not willing to participate in the study <br/ ><br>→ | | | How the work from home is affecting Stress level and itâ??s association with nutritional status of the IT professionals during COVID-19 pandemicTimepoint: 5 weeks and 5 days <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/11/029146 | 27 January 2021 | Use of a new breathing device for covid 19 patients | Usage of Novel Non-Invasive Ventilation among
Covid-19 patients: A prospective two arm open labelled randomized controlled trial | | JFD Limited | 16-11-2020 | 20201116 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48879 | Not Recruiting | No | | | | 23-11-2020 | 240 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | N/A | India→ | Dr Alben Sigamani→ | | #258/A, Bommasandra Industrial area, Anekal taluk, Bangalore → | vimal.bhardwaj.dr@narayanahealth.org→ | 919686124830→ | Mazumdar Shaw Medical Center→ | Inclusion criteria: 1. Patient may be diagnosed with COVID-19 pneumonia based on clinical history consistent with COVID 19 without PCR proof <br/ ><br>2.Acute lung injury as evidenced by P/F ratio <300 <br/ ><br>3. Clinician deems failure of therapy with conventional low flow oxygen→ | Exclusion criteria: 1.Need for direct admission to the intensive care unit for invasive ventilation <br/ ><br>2.Unconscious or patient with drowsiness. <br/ ><br>3. Pneumothorax.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Novel Non-Invasive Ventilation<br>Device [InVictoâ?¢]: We will connect the patients in the intervention group to InVictoâ?¢ device. The pressure, flow and FiO2 will be set by the intensivists as per the clinical condition of the patient<br>Control Intervention1: Hospital standard treating protocol: Patients in the control group will be prescribed the non-invasive breathing support using HFNC system as defined by existing hospital protocol, or nasal CPAP where local clinicians prefer. The Flow and FiO2 will be set by the intensivists as per the clinical condition of the patient<br>→ | The co-primary efficacy outcome for this trial is a <br/ ><br>composite of invasive ventilation or death at 30 days after randomization. <br/ ><br>The co-primary safety outcome for this trial is any incident cases of hypopnea that results from a failure of the device at 30 days after randomizationTimepoint: 30 days after randomization→ | | | | Yes | False | | |
| → | CTRI/2020/11/029170 | 27 January 2021 | Lignocaine nebulisation in covid pneumonia | Lignocaine nebulisation for patients with Covid -19 Respiratory infection:An Exploratory randomised double blinded controlled trial | | AIIMS Rishikesh | 17-11-2020 | 20201117 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49412 | Not Recruiting | No | | | | 20-11-2020 | 60 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | N/A | India→ | Dr Praveen Talawar→ | | 6th floor
Medical college building
AIIMS Rishikesh Department of Anaesthesiology
6th floor
Medical college building
AIIMS
Rishikesh→ | praveenrt64@gmail.com→ | 9654162941→ | AIIMS Rishikesh→ | Inclusion criteria: Patients with PCR documented Covid -19 infection with respiratory distress(presence of hypoxia with Spo2 <93% or radiographic evidence of pneumonia,any single organ failure,sepsis)requiring supplemental oxygenation or non-invasive mechanical ventilation.→ | Exclusion criteria: 1.Refusal to participate in the study <br/ ><br>2.Known allergy to lignocaine <br/ ><br>3.Patient requiring invasive mechanical ventilation/Septic shock→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: Nebulisation<br>: Study solution in 4ml of volume, nebulized over 15 min, every 6th hourly<br>Control Intervention1: 2% lignocaine 4ml nebulization: Nebulization over 15 min every 6h hourly till the duration of study<br>Control Intervention2: Distill water (4ml) nebulization: Distill water (4ml) nebulization over 15 min, every 6th hourly till the duration of study<br>→ | 1.Oxygenation improvement as measured by Spo2 and ABG <br/ ><br>2.Duration of supplemental oxygen requirement <br/ ><br>3.Decrease in the need for invasive mechanical ventilation.Timepoint: Patient is improved or getting worse to receive mechanical ventilation or death. <br/ ><br>Monitored on daily basis while on receiving study intervention <br/ ><br>till the study period <br/ ><br> <br/ ><br>the study ends after patient improvement or worsens to mechanical ventilation→ | | | | Yes | False | | |
| → | CTRI/2020/11/029148 | 27 January 2021 | Difficulties encountered with respiration while providing analgesia for surgeries to patients who had recovered from Covid-19 infection | Perioperative pulmonary complications in Covid-19 recovered patients during elective surgeries under General Anesthesia- An observational Prospective study | | SRM Medical College Hospital and Research Centre | 17-11-2020 | 20201117 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49160 | Not Recruiting | No | | | | 20-11-2020 | 50 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr CR Saravanan→ | | Room No 201
Department of Anesthesiology
SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE
SRMIST
Potheri
Kancheepuram
Tamilnadu Department of Anesthesiology
SRM MEDICAL COLLEGE HOSPITAL→ | daredoparam@gmail.com→ | 9994613023→ | SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE→ | Inclusion criteria: Patient who has become negative of COVID infection 28 days before surgery <br/ ><br>Patients with history of COVID-19 infection <br/ ><br>→ | Exclusion criteria: Age >60 <br/ ><br>ASA 3-4 <br/ ><br>Patients with other respiratory illness like Bronchial asthma, COPD, Tuberculosis <br/ ><br>Difficult airway <br/ ><br>Patients posted for CTVS surgeries <br/ ><br>→ | Health Condition 1: J128- Other viral pneumonia
→ | | To assess the incidence of post-operative pulmonary complication in post COVID patientTimepoint: From the onset of surgery till 24 hours postoperative period→ | | | | Yes | False | | |
| → | CTRI/2020/11/029188 | 27 January 2021 | Quality of life in post covid affected patients | Assessment of quality of life in patients who have recovered from SARS -COV 2 infection | | Sri Ramachandra University | 17-11-2020 | 20201117 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47149 | Not Recruiting | No | | | | 17-11-2020 | 500 | Observational | Cluster Randomized Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Suja Lakshmanan→ | | DEPARTMENT OF GENERAL MEDICINE,
SRI RAMACHANDRA UNIVERSITY PORUR
CHENNAI
Thiruvallur
TAMIL NADU
600116
India
→ | suja.lakshmanan@gmail.com→ | | Sri Ramachandra Institute of Higher Education And Research→ | Inclusion criteria: 1. All confirmed cases of SARS- Cov-2 infections admitted in ward, HDU and Critical care ICU. <br/ ><br>2. All confirmed cases of SARS- Cov-2 infections with age group of 18 years and above. <br/ ><br>3. All patients who have a standard positive COVID RT -PCR test <br/ ><br>→ | Exclusion criteria: All confirmed cases of SARS- Cov-2 infections with age group of less than 18 years and below. <br/ ><br>2. Patients who have RTPCR for SARS COV2 infection negative but serology test positive. <br/ ><br>3. Patients discharged without fulfilling the discharge criteria which includes AMA <br/ ><br>4. Patients who are declared. <br/ ><br>→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: Persistent symptoms and quality of life post SARS COV 2 infection: Comparison of quality of life in patients post SARS COV 2 between mild, moderate and severe covid category<br>Control Intervention2: nil: nil<br>→ | 1.To assess persistent symptoms in patients who were discharged from hospital after recovery from SARS COV 2 infection. <br/ ><br>2. To assess the quality of life in patients who were discharged from hospital after recovery from SARS COV 2 infection . <br/ ><br>Timepoint: 3 months <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/11/029174 | 27 January 2021 | Impact of COVID 19 on domestic responsibilities in physicians | Impact of COVID-19 Pandemic on domestic responsibility among physicians | | Tata memorial Hospital | 17-11-2020 | 20201117 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48433 | Not Recruiting | No | | | | 30-11-2020 | 2000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sabita Jiwnani→ | | Department of surgical Oncology
Thoracic Surgery Division
Homi Bhabha Building, Room number 301
Dr. E Borges Road, parel, mumbai → | sabitajiwnani@gmail.com→ | 9820542843→ | Tata memorial hospital→ | Inclusion criteria: COVID-19 has brought about the most unprecedented public health and socio-economic crisis in our lifetime. It affects us all, especially the physicians. This is an electronic questionnaire-based survey study to find out the impact of the pandemic and subsequent lockdown on the domestic responsibilities amongst physicians. <br/ ><br>This questionnaire is voluntary and anonymous. No identifiable information will be collected and filling out the survey will mean implied consent. <br/ ><br>The questionnaire does not include any information about patients. The questions included pertain to the absence or limited availability of domestic help and childcare facilities and the subsequent difficulties faced by physicians at home and the workplace. <br/ ><br>→ | Exclusion criteria: Nil→ | | | Differences in increased domestic responsibilities due to genderTimepoint: one month after sending questionnaire <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/11/029159 | 27 January 2021 | Study to evaluate the knowledge, attitude and mental health of in-hospital front-line warriors of operation theatre | Knowledge, Attitude and Mental State of Healthcare Workers during Covid-19 Pandemic | | Government Medical College and Hospital Chandigarh | 17-11-2020 | 20201117 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44643 | Not Recruiting | No | | | | 20-11-2020 | 200 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | N/A | India→ | Sukanya Mitra→ | | 5th floor, Block D
Department of Anaesthesiology and Intensive Care, Government Medical College and Hospital, Chandigarh → | drsmitra12@yahoo.com→ | 9646121521→ | Government Medical College and Hospital→ | Inclusion criteria: All the healthcare workers of GMCH working in GMCH who will provide informed consent will be included in the study. The healthcare workers will include faculty members, junior and senior residents of anaesthesia, surgery, gynecology and orthopedic departments. We will also include anaesthesia technicians, nursing staff, attendants and sweepers working in intensive care units and operation theaters.→ | Exclusion criteria: The healthcare worker who will not provide informed consent will be excluded from the study→ | | Intervention1: Depression, Anxiety and Stress Scale-21 (DASS 21): The questionnaire consists of 4 sections â?? section 1, 2 ,3 and 4.<br>Section 1 includes demographic and other baseline data (age, gender, profession, work-experience, COVID training and work services).<br>Section 2 includes questions to evaluate the knowledge of healthcare workers regarding covid operation theater.<br>Section 3consists of 15 attitudes questions regarding different policies on COVID -19. It includes items like: All patients including non COVID patients should be operated using level 3 Personal Protective Equipment (PPE), COVID negative patients may be posted for elective surgeries, Hospital shall provide quarantine facilities for the healthcare workers working in COVID areas. All the attitudes questions are in four options format â?? â??yesâ??, â??noâ?? , â??not sure/canâ??t sayâ?? and â??not applicableâ??.<br>Section 4 includes 21 self-reported items which measure the emotional states of depression, anxiety and stress with 7 items each.(DASS - 21)<br>→ | To evaluate the knowledge and attitude related to the coronavirus disease 2019(COVID-19) pandemic and mental status of healthcare workers working in Government Medical College and Hospital (GMCH) ChandigarhTimepoint: At the time of Covid-19 pandemic with increasing trajectory→ | | | | Yes | False | | |
| → | CTRI/2020/11/029173 | 27 January 2021 | What does Covid 19 do to patients with long standing Kidney disease and the impact of treatment on their course in hospital - a tertiary care hospital study | Clinical profile of Chronic Kidney disease (CKD)patients with COVID-19
- A Study in a Tertiary Care Centre. | | Kasturba Medical College Manipal | 17-11-2020 | 20201117 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49522 | Not Recruiting | No | | | | 01-12-2020 | 62 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr B A SHASTRY→ | | Department of General Medicine Kasturba Medical College, Manipal,
Udupi
KARNATAKA
576104
India → | ba.shastry@manipal.edu→ | 9845702450→ | Kasturba Medical College, Manipal→ | Inclusion criteria: 1. All Adult patients above 18 yrs of age admitted with COVID and Kidney disease between <br/ ><br>30/03/2020 to 30/09/2020. <br/ ><br> <br/ ><br>2. CKD (all Stages with eGFR <60 ml/min/1.73 m2 according to the CKD-EPI Equation) <br/ ><br>Newly diagnosed with COVID-19 by RT-PCR or Rapid antigen Test (RAT). <br/ ><br> <br/ ><br>Classification is based on the Kidney Disease Improving Global Outcome <br/ ><br>(KDIGO) classification of chronic kidney disease (CKD).→ | Exclusion criteria: Patients less than 18 years of age→ | Health Condition 1: N189- Chronic kidney disease, unspecified
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. Initial presentation and symptomatology <br/ ><br> <br/ ><br>2. Initial laboratory parameters and radiographic findings <br/ ><br> <br/ ><br>3. Course in the hospital from the day of admission.Timepoint: day 1,3,5,7,10, 14, etc., till discharge, DAMA, death→ | | | | Yes | False | | |
| → | CTRI/2020/11/029172 | 27 January 2021 | Effect of the globally spread Covid-19 on the diet and lifestyle of adults (25-60 years) | Effect of the Covid-19 pandemic on the diet and lifestyle of adults (25-60 years) | | Jasmine Tamak | 17-11-2020 | 20201117 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49271 | Not Recruiting | No | | | | 23-11-2020 | 200 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Deeksha Lobo→ | | Room #204
Department of Dietetics and
Applied Nutrition
Welcomgroup Graduate School of Hotel Administration
Manipal Academy of Higher Education
Manipal → | pallavi.wgsha@manipal.edu→ | 9591273054→ | Welcomgroup Graduate School of Hotel Administration→ | Inclusion criteria: Those who can read and understand English. <br/ ><br>Must be physically and mentally stable. <br/ ><br>→ | Exclusion criteria: People outside the selected age group. <br/ ><br>Vulnerable groups (pregnant & lactating mothers, people with chronic conditions). <br/ ><br>Those who cannot read and understand English. <br/ ><br>→ | | | Dietary pattern and eating habitsTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/11/029175 | 27 January 2021 | Role of Heparin inhalation in reducing the duration the patient is breathing with the help of a ventilator | Role of Heparin Nebulization in Reducing Time of Mechanical ventilation in patients with SARS-CoV-2 | | AIIMS Patna | 17-11-2020 | 20201117 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49022 | Not Recruiting | No | | | | 01-12-2020 | 58 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded | N/A | India→ | Shagufta Naaz→ | | Associate professor, department of Anaesthesiology, AIIMS Patna, Phulwarisharif Patna 801507 → | drshaguftanaaz@gmail.com→ | 07765937919→ | AIIMS Patna→ | Inclusion criteria: Confirmed COVID-19, Endotracheal tube in place, Intubated the day before or same day, PaO2 to FIO2 ratio less than or equal to 300 while intubated, Acute opacities not fully explained by effusions, lobar/lung collapse and nodules, affecting at least one lung quadrant on chest X-ray or CT, Currently in the ICU or scheduled for transfer to the ICU. <br/ ><br>→ | Exclusion criteria: Enrolled in another clinical trial that is unapproved for co-enrolment, Heparin allergy or HIT, APTT > 120 seconds and this is not due to anticoagulant therapy, Platelet count < 20 x 109 per L, Pulmonary bleeding, which is frank bleeding in the trachea, bronchi or lungs with, Repeated haemoptysis or requiring repeated suctioning, Uncontrolled bleeding, Pregnant or might be pregnant, Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain-Barre syndrome, Usually receives home oxygen, Death is imminent or inevitable within 24 hours <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J22- Unspecified acute lower respiratory infection
→ | Intervention1: Heparin Nebulization plus Standard care: Each participant will be assigned to nebulised heparin sodium 25,000 Units in 5 mL or an equivalent unfractionated heparin, the frequency being 6-hourly till extubation or upto 10 days whichever is earlier.<br>Control Intervention1: Standard Care: Each participant will be assigned to standard care. They will not be nebulized with heparin.<br>→ | The primary outcome is the time to separation from mechanical ventilation (duration of mechanical ventilation) upto day 28Timepoint: The primary outcome is the time to separation from mechanical ventilation (duration of mechanical ventilation) upto day 28→ | | | | Yes | False | | |
| → | CTRI/2020/11/029166 | 27 January 2021 | Curaneum 20 for Covid 19 | Efficacy of Curaneum 20 as a therapy against SARS-CoV-2 (COVID 19) | | Dr Sant Prabhudasji | 17-11-2020 | 20201117 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46785 | Not Recruiting | No | | | | 01-12-2020 | 200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Double Blind Double Dummy | Phase 3 | India→ | Arunaloke Chakrabarti→ | | Department of Medical Microbiology
PGIMER, Chandigarh → | arunaloke@hotmail.com→ | 01722755155→ | Department of Medical Microbiology, PGIMER, Chandigarh→ | Inclusion criteria: · Age >18 years <br/ ><br>· Laboratory confirmed infection with SARS-Cov-2 <br/ ><br>· In patient admission to SARS-Cov-2 therapy <br/ ><br>· Signed informed consent <br/ ><br>→ | Exclusion criteria: · Patients <18 years <br/ ><br>· Pregnant or breast-feeding <br/ ><br>· Participating in other clinical trial <br/ ><br>· Not signing informed consent <br/ ><br>→ | Health Condition 1: A00-B99- Certain infectious and parasitic diseases
→ | Intervention1: Curaneum 20: In the intervention arm one drop of Curaneum 20 will be provided in patientsâ?? mouth twice daily for five days.<br>Control Intervention1: Placebo: In the Comparator group of patients one drop of sterile distilled water will provided in the mouth twice daily for five days. Both drug and placebo will be in dispensed in similar containers marking as â??Aâ?? and â??Bâ?? to keep the drug prescriber blind of product. There will be no interfer-ence in standard management of Covid 19 patients. The trial drug or placebo will be provided in addition of standard therapy.<br>→ | Discharge after cure or deathTimepoint: till the patient is discharged or died→ | | | | Yes | False | | |
| → | CTRI/2020/11/029171 | 27 January 2021 | Mothers view on the impact of increased screen time on the overall health of school going children during COVID-19 | A survey from mothers perspective on the impact of increased screen timing on the overall health status of school-going children during COVID-19 | | Alfa F Rodrigues Krithika Rai | 17-11-2020 | 20201117 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49097 | Not Recruiting | No | | | | 22-11-2020 | 261 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Mrs Swathi Acharya K→ | | Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education → | swathi.acharya@manipal.edu→ | 9535071393→ | Welcomgroup Graduate School of Hotel Administration→ | Inclusion criteria: Mothers having children aged between 5-13 years, mothers of children attending online classes, <br/ ><br>mothers who can do the questionnaire independently→ | Exclusion criteria: Mothers of children below 5 and above 13 years of age. Mothers of specially <br/ ><br>challenged children and children who are not attending online classes. Mothers <br/ ><br>who cannot do the questionnaire independently. <br/ ><br>→ | | | The impact of increased screen timing on the overall health status of school- going children during COVID-19Timepoint: Single time point→ | | | | Yes | False | | |
| → | CTRI/2020/11/029200 | 27 January 2021 | Psychological effect of COVID 19 on Positive female patient | Psychological impact of COVID 19 on positive female patient presenting to our dedicated COVID hospital: A cross sectional study
| | Department of anaesthesiology | 18-11-2020 | 20201118 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49556 | Not Recruiting | No | | | | 25-11-2020 | 25 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Dr Poonam Kumari→ | | Department of anaesthesia ,B block ,5th floor ,OT complex ,faculty lounge, AIIMS Patna
→ | drpoonam1981@gmail.com→ | 9473199126→ | Aiims Patna→ | Inclusion criteria: female patients,understand Hindi language→ | Exclusion criteria: unwilling and not provide informed consent, severe medical-surgical or psychiatric illness, physical handicap, marital separation or divorce→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | This questionnaire will be helped us to determine the stress or anxiety faced by COVID positive female patients in due to their disease.Timepoint: one month→ | | | | Yes | False | | |
| → | CTRI/2020/11/029203 | 27 January 2021 | To determine the impact of latent tuberculosis on severity and outcomes in patients with suspected SARS-COV-19 infection | To determine the impact of latent tuberculosis on severity and outcomes in patients with suspected SARS-COV-19 infection - LATTICE | | AIIMS Research Section | 18-11-2020 | 20201118 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46554 | Not Recruiting | No | | | | 30-11-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Pavan Tiwari→ | | Room no 10,
DEPT OF PULMONARY Critical Care and Sleep Medicine
Third Floor Porta Cabin
New Private Ward
All India INstitute of Medical Sciences, Ansari Nagar East
New Delhi → | pavan14281@gmail.com→ | 9968846678→ | AIIMS→ | Inclusion criteria: Consecutively admitted COVID positive patients→ | Exclusion criteria: Refusal of consent <br/ ><br>Active tuberculosis <br/ ><br>HIV <br/ ><br>Post 72 hours of admission or more than 7 days of symptom onset <br/ ><br>Any known immunodeficiency <br/ ><br>Pregnancy <br/ ><br>Malignancy <br/ ><br>Any other known systemic infection or disease altering T cell pathway <br/ ><br>→ | Health Condition 1: A00-B99- Certain infectious and parasitic diseases
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Mantoux test and Interferon gamma release assay: Outcome evaluation in patients tested positive for latent tuberculosis<br>Control Intervention1: Mantoux test and Interferon gamma release essay: Outcome evaluation in patients tested negative for latent tuberculosis<br>→ | To determine prevalence of latent tuberculosis with respect to severity of illness amongst suspected SARS-COV-19 patientsTimepoint: At enrollment→ | | | | Yes | False | | |
| → | CTRI/2020/11/029233 | 27 January 2021 | An observation and comparison of the efficacy and relative satisfaction of Health Care Workers while being monitored by the standard BUDDY technique versus the Remote Audio Visual Doffing Surveillance (RADS) of the doffing process during the COVID 19 Pandemic | Comparison of the efficacy and relative satisfaction of Remote Audio-visual Doffing Surveillance (RADS) technique versus the standard buddy technique for monitoring the doffing process of health care workers during COVID 19 pandemic : an observational study | | Naveen Naik B | 19-11-2020 | 20201119 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49177 | Not Recruiting | No | | | | 15-12-2020 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Naveen Naik B→ | | Department of Anaesthesia and Intensive Care, Fourth Floor, Nehru Hospital, Post Graduate Institute of Medical Education and Research, Chandigarh - 160012 → | navin.amc123@gmail.com→ | 8872377925→ | Post Graduate Institute Of Medical Education And Research→ | Inclusion criteria: 1. Should have undergone training in the donning and doffing process at least once or twice. <br/ ><br>2. A member of the staff working at the COVID unit in PGIMER. <br/ ><br>→ | Exclusion criteria: 1. The HCW who will be doffing for the first time. <br/ ><br>2. The HCW doffing due to an emergency (health issue of the HCW, or due to an observed damage in the PPE). <br/ ><br>3. Pregnant, breast feeding, history of joint replacements or other prosthetic devices, inflammatory skin conditions or having open wounds. <br/ ><br>4. Refuses to participate in the study. <br/ ><br>5. HCW who is performing this study. <br/ ><br>→ | | Intervention1: Remote Audio visual surveillance technique of monitoring the doffing process: The doffing process of the Health Care Workers will be observed from a console room via a camera installed in the doffing area. A person blinded to the purpose of the study will be monitoring the doffing process. The step at which the breech in the protocol occurs, or where the health worker commits an error and / or is corrected by the monitoring staff will be noted by another silent observer.<br>→ | To study and compare the incidence of error with regard to the standard CDC doffing guidelines during the doffing process of health care workers while they are being monitored by a buddy and also when they are being monitored using Remote Audio-visual Doffing Surveillance (RADS) monitoring system.Timepoint: Comparison will be done after completion of all the case observations i.e at the end of the study→ | | | | Yes | False | | |
| → | CTRI/2020/11/029221 | 27 January 2021 | Measurement of Quality of food intake, mental health status, and safety measures followed by the hospital support staff during COVID-19. | Assessment of Diet quality, mental health status, and safety measures
followed by the hospital support staff during COVID-19. | | P Vaishnavi Yadav | 19-11-2020 | 20201119 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49250 | Not Recruiting | No | | | | 24-11-2020 | 354 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Apoorva Jain→ | | Room no 204 First floor Department of Dietetics and Applied Nutrition
Welcomgroup Graduate School of Hotel administration Manipal Academy of Higher Education
Manipal Karnataka → | pallavi.wgsha@manipal.edu→ | 9591273054→ | Welcomgroup Graduate School of Hotel Administration→ | Inclusion criteria: All the housekeeping staff working in Kasturba Hospital, Manipal. <br/ ><br>Participants who are willing to participate in the study <br/ ><br>→ | Exclusion criteria: Housekeeping staff who work in any other hospital other than Kasturba hospital, Manipal. <br/ ><br>Housekeeping staff who are not on a regular rotation of shift in Kasturba Hospital, Manipal. <br/ ><br>Participants who are not willing to participate in the study.→ | | | Assess the quality of the diet affected by the pandemic among the housekeeping staffTimepoint: Once at baseline→ | | | | Yes | False | | |
| → | CTRI/2020/11/029235 | 27 January 2021 | Impact of COVID-19 on screen time, physical activity, sleep pattern and food intake among students of 18-23 years. | Implications of COVID-19 on screen time, physical activity, sleep pattern and dietary intake among students (18-23 years). | | Reshma Mariam Santhosh | 19-11-2020 | 20201119 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49267 | Not Recruiting | No | | | | 23-11-2020 | 478 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Reshma Mariam Santhosh→ | | Room number 204, First floor, Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Manipal Academy of Higher Education, Manipal Room number 204, First floor, Manipal Academy of Higher Education, Manipal, Karn→ | pallavi.wgsha@manipal.edu→ | 9591273054→ | Welcomgroup Graduate School of Hotel Administration→ | Inclusion criteria: 1. Students of Manipal Academy of Higher Education, aged 18-23 years, both years inclusive <br/ ><br>2. Willingness to participate in the study <br/ ><br>→ | Exclusion criteria: 1. Students who are pregnant or lactating <br/ ><br>2. Not willing to participate in the study <br/ ><br>→ | | | Implications of COVID-19 on screen time, physical activity, sleep pattern and dietary intake among students aged 18-23 years will be found out.Timepoint: Once at baseline→ | | | | Yes | False | | |
| → | CTRI/2020/11/029232 | 27 January 2021 | Role Of Montelukast In Management Of COVID 19 | Efficacy Of Montelukast In the Management Of COVID 19 - A Double Blind Randomized Placebo Controlled Trial - EMMC | | NIL | 19-11-2020 | 20201119 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49293 | Not Recruiting | No | | | | 25-11-2020 | 90 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | DR VIJAY KUMAR→ | | ASSOCIATE PROFESSOR, DEPT OF GENERAL MEDICINE
AIIMS, PHULWARISHARIF
PATNA ASSOCIATE PROFESSOR, DEPT OF GENERAL MEDICINE
AIIMS, PHULWARISHARIF
PATNA→ | vijaykr@aiimspatna.org→ | 9431414308→ | AIIMS PATNA→ | Inclusion criteria: All patients above the age of 14 years both males and females, admitted with a <br/ ><br>diagnosis of mild or moderate COVID -19 (on the basis of a positive RT-PCR report) at our facility <br/ ><br>during the study period (01/09/2020-31/12/2020)→ | Exclusion criteria: 1. Patients with a known allergy to or adverse drug reaction with Montelukast. <br/ ><br>2. Patients unable to provide consent or unwilling to participate in the study. <br/ ><br>3. Patients included in any other ongoing trial will be excluded from the study. <br/ ><br>4. Patients below the age of 14 years will be excluded from the study. <br/ ><br>5. Pregnant and Lactating Females will be excluded from the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Montelukast: 10 mg Montelukast tablet daily at bed time for 10 days<br>Control Intervention1: Placebo: Similar looking palcebo tablet at bed time for 10 days.<br>→ | 1. Progression of the disease to severe grade. <br/ ><br>2. Admission to ICU . <br/ ><br> <br/ ><br>3. Need for mechanical ventilation. <br/ ><br>4. In-hospital mortalityTimepoint: At every week→ | | | | Yes | False | | |
| → | CTRI/2020/11/029230 | 27 January 2021 | ROLE OF VITAMIN C IN MANAGEMENT OF COVID 19 | EVALUATION OF THE EFFICACY OF INTRAVENOUS VITAMIN C IN THE MANAGEMENT OF COVID 19 -A Prospective Randomized Controlled Trial - VCMC | | NIL | 19-11-2020 | 20201119 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49295 | Not Recruiting | No | | | | 20-11-2020 | 80 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | DR VIJAY KUMAR→ | | AIIMS, PHULAWARISHARIF, PATNA, BIHAR AIIMS, PHULAWARISHARIF, PATNA, BIHAR→ | vijaykr@aiimspatna.org→ | 9431414308→ | AIIMS PATNA→ | Inclusion criteria: All patients above the age of 18 years both males and females, admitted with a diagnosis of <br/ ><br>Moderate & Severe COVID -19 (on the basis of a positive RT-PCR report) at our facility during the <br/ ><br>study period (16/08/2020-15/12/2020)→ | Exclusion criteria: 1. Patients with a known allergy to or adverse drug reaction with vitamin C. <br/ ><br>2. Patients unable to provide consent or unwilling to participate in the study. <br/ ><br>3. Patients participating in any other ongoing clinical trial will be excluded from the study. <br/ ><br>4. Patients below the age of 18 years will be excluded from the study. <br/ ><br>5. Pregnant or Breastfeeding Females will be excluded from the study. <br/ ><br>6.Patients previously complicated with End-stage Lung Disease, End stage Malignancy, Glucose-6- <br/ ><br>Phosphate dehydrogenase deficiency, Diabetes Mellitus & Diabetic Ketoacidosis , Nephrolithiasis, <br/ ><br>Chronic Kidney Disease, Cardiogenic Pulmonary Edema will be Excluded from the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: INTRAVENOUS VITAMIN C: 1 GRAM INTRAVENOUS VITAMIN C IV 8 HOURLY FOR 4 DAYS.<br>Control Intervention1: Placebo: SIMILAR LOOKING PLACEBO VIALS CONTAINING NS OR WATER FOR INJECTION IV 8 HOURLY FOR 4 DAYS<br>→ | 1. Clinical Recovery From the disease . <br/ ><br>2. In Hospital Mortality .Timepoint: AT WEEKLY INTERVAL→ | | | | Yes | False | | |
| → | CTRI/2020/11/029236 | 27 January 2021 | Patient satisfaction with psychiatry services during the pandemic | A survey on patient satisfaction with psychiatry services during Covid 19 pandemic. | | Bhabha Atomic Research Centre Hospital | 19-11-2020 | 20201119 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48376 | Recruiting | No | | | | 01-12-2020 | 347 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 4 | India→ | Dr Saumitra Nemlekar→ | | 176B, Room No. 1, Psychiatry Unit
BARC Hospital
Anushakti Nagar
Mumbai → | ssnemlekar@barc.gov.in→ | 02225598113→ | BARC Hospital Mumbai→ | Inclusion criteria: 1. Psychiatric out-patients and caregivers who had previously consulted at Psychiatry OPD <br/ ><br>2. Age > 18 years <br/ ><br>3. New patients who perceived the need to seek psychiatric care during the Covid-19 pandemic and sought care either during or after the lockdown period. <br/ ><br>→ | Exclusion criteria: 1. Non-consent to participate <br/ ><br>2. New patients attending the Psychiatric services. These patients did not perceive any need for psychiatric help during the lockdown or prior. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Survey of satisfaction with psychiatry services. We will also note their grievances and suggestions to improve servicesTimepoint: 1 day→ | | | | Yes | False | | |
| → | CTRI/2020/11/029263 | 27 January 2021 | A clinical study on Favipiravir in mild to moderate COVID-19 patients | Prospective, Open label, Multicentre, Single Arm, Post Marketing study for evaluation of safety and efficacy of Favipiravir in Adult Indian Patients with Mild to Moderate COVID-19 disease | | Glenmark Pharmaceuticals Ltd | 20-11-2020 | 20201120 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46353 | Recruiting | No | | | | 30-11-2020 | 1200 | PMS | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Post Marketing Surveillance | India→ | Rajesh Gaikwad→ | | Glenmark Research Centre, A-607, MIDC Mahape, Navi Mumbai
→ | Saiprasad.Patil@glenmarkpharma.com→ | | Glenmark Pharmaceuticals Ltd.→ | Inclusion criteria: 1. Adult patients aged 18 years and above with mild to moderate COVID-19. <br/ ><br>2. Patients who receive a prescription of favipiravir according to the indication stated in the approved prescribing information in India <br/ ><br>3. Pyrexia (defined as axillary temperature more than or equal to 99 F or oral temperature more than or equal to 100 F) AND at least one of the following: Cough, fatigue, dyspnoea, expectoration, myalgia, rhinorrhoea, sore throat, diarrhoea, new loss of taste or smell, myalgia, headache or fatigue on admission. <br/ ><br>4. Respiratory rate less than or equal to 30/min. <br/ ><br>5. SpO2 more than or equal to 90% on room air. <br/ ><br>6. Agree to follow effective contraceptive methods during and for 7 days after the end of the treatment with favipiravir for male and female patients in the reproductive age group. <br/ ><br>7. For female patients of child-bearing age: evidence of negative pre-treatment urine pregnancy test <br/ ><br>8. Voluntarily participating in the study; fully understanding and being fully informed of the study and having signed written Informed Consent Form (ICF). Also if a pregnancy is reported, consent should be given for follow up of pregnancy until outcome.→ | Exclusion criteria: 1. Refusal to participation expressed by patient or legally authorized representative. <br/ ><br>2. Requiring NIV, Mechanical Ventilation or ECMO at baseline. <br/ ><br>3. Severe hepatic or renal impairment <br/ ><br>4. Pregnant or lactating women. <br/ ><br>5. History of known hypersensitivity to Favipiravir. <br/ ><br>6. Requires ICU care for management of ongoing clinical status (respiratory failure, septic shock, and/or multiple organ dysfunction or failure) <br/ ><br>7. Patients who have participated in any clinical trial within 30 days prior to enrolment and would not be participating in clinical study during the period of study participation. <br/ ><br>8. Any other COVID-19 antiviral treatment.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Favipiravir 200 mg / 400 mg: 3600 mg (1800 mg orally twice daily) on 1st day followed by 800 mg orally twice daily, up to maximum of 14 days<br>Control Intervention1: NA: NA<br>→ | To evaluate the safety of favipiravir prescribed in treatment of patients with mild to moderate COVID-19 disease in India. <br/ ><br>1. Number of AEs <br/ ><br>2. Number of SAEs <br/ ><br>3. Number of treatment related AEs and SAEs as assessed by the treating physician <br/ ><br>4. Number of AEs leading to dose modification/ discontinuation of treatmentTimepoint: Upto 28 days→ | | | | Yes | False | | |
| → | CTRI/2020/11/029265 | 27 January 2021 | Preventive trial of Homoeopathic medicines in COVID-19 | Prophylactic effects of homoeopathic medicines in Kolkata during COVID-19 pandemic: A community-based, randomized trial | | Ministry of AYUSH Govt of India | 20-11-2020 | 20201120 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48401 | Not Recruiting | No | | | | 30-11-2020 | 20000 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3 | India→ | Prof Dr Satadal Das→ | | Dept. of Pathology and Microbiology, 12, Gobinda Khatick Road, Tangra → | ganguly.subhasish@rediffmail.com→ | 8017272982→ | D N De Homoeopathic Medical College and Hospital, Govt. of West Bengal→ | Inclusion criteria: a) Persons residing in the Tangra area of Kolkata <br/ ><br>b) Age between 1 yr and 75 yrs <br/ ><br>c) Participants of either sex <br/ ><br>d) Written consent to participate (guardianâ??s consent in cases of minors)→ | Exclusion criteria: a) Diagnosed or suspected cases of COVID-19 <br/ ><br>b) Currently suffering from flu-like illnesses <br/ ><br>c) People who have already taken homoeoprophylaxis in some forms within last 30 days <br/ ><br>d) Cases with vital organ failure <br/ ><br>e) Immune compromised state→ | | Intervention1: Bryonia alba 30CH; 6 doses once daily for 6 days (for adults) or 3 doses for 3 days (for infants/children); plus ascorbic acid tablets of 500 mg per day for 6 days for participants aged 5-75 years: Bryonia alba 30CH (preserved in 90% v/v ethanol); 3 (for children) or 6 (for adults) doses once daily in morning for 3 or 6 days. Each dose shall consist of either 2 (for infants/children) or 4 (for adults) medicated globules (no. 30) of cane sugar, to be taken orally on clean tongue with empty stomach. Participants will be advised to refrain from handling the globules or from eating, drinking, smoking or brushing teeth within 30 minutes of taking the globules and will be asked to suck the globules rather than simply swallowing those. All medicines and sundry items have been procured from Hahnemann Publishing Company - a Good Manufacturing Practice (GMP)-certified firm. Along with this, ascorbic acid tablets of 500 mg (Dusap Pharmaceuticals) per day for 6 days for participants aged 5-75 years will be advised once per day for 6 days. A minimum of one hour interval should be kept between the intake of homoeopathic medicine and ascorbic acid tablets. Along with that, general hygienic measures like hand washing, maintaining social distancing, proper use of mask, gloves etc. and healthy dietary advices will be given to all participants. Route of administration: Oral. Duration of therapy: 3 (for children) or 6 (for adults) days.<br>Intervention2: Gelsemium sempervirens 30CH; 6 doses once daily for 6 days (for adults) or 3 doses for 3 days (for infants/children); plus ascorbic acid tablets of 500 mg per day for 6 days for participants aged 5-75 years: Gelsemium sempervirens 30CH (preserved in 90% v/v ethanol); 3 (for children) or 6 (for adults) doses once daily in mornin→ | Occurrence of newly diagnosed (laboratory confirmed by PCR) COVID-19 infection rates across the groupsTimepoint: Up to 30 days after completing the recommended dosage or once the person reports COVID-19 positive by PCR tests, whichever is earlier→ | | 19/01/2021 | | Yes | False | | |
| → | CTRI/2020/11/029264 | 27 January 2021 | To study the long term ill effects of covid 19 infection in old age people | Persisting symptoms with long term physical, functional, social and mental morbidity in elderly who have recovered from covid 19 infection. A cross sectional survey | | Sri Ramachandra Institute of higher education and research | 20-11-2020 | 20201120 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47176 | Not Recruiting | No | | | | 01-12-2020 | 400 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sathyamurthy→ | | Department of general medicine,
Sri Ramachandra Institue of higher education and research,
no 1 , Sri ramachandra nagar
porur,chennai → | drsams30@sriramachandra.edu.in→ | 9840514232→ | sriramachandra university of higher education and research→ | Inclusion criteria: Elderly people more than or equal to 60 yrs of age who have recovered from covid 19 infection→ | Exclusion criteria: 1. Patients who are less than 60 yrs of age <br/ ><br> <br/ ><br>2. Elderly who have died due to covid 19 infection→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | New knowledge about persisting symptoms and long term complications with morbidity in elderly people who have recovered from covid 19 infectionTimepoint: 3 months following recovery→ | | | | Yes | False | | |
| → | CTRI/2020/11/029266 | 27 January 2021 | Response of patients and chest x-ray improvement after Remdesivir | Assessment of novel inflammatory, clinical and radiological
response (â??Brixiaâ?? chest X ray score) to remdesivir in moderate and severe COVID-19
patients : a retrospective study | | Vishal Shanbhag | 20-11-2020 | 20201120 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49576 | Not Recruiting | No | | | | 04-12-2020 | 126 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Vishal Shanbhag→ | | Department of Critical Care Medicine, Kasturba Medical College, Madhav Nagar, Manipal,Karnataka
Pin - 576104 → | vishal.shanbhag@manipal.edu→ | | Kasturba medical College, Manipal→ | Inclusion criteria: Patients aged 18-90 years were included <br/ ><br>Patients who have been proven COVID-19 positive by reverse transcriptase polymerase chain reaction (RT-PCR),and the rapid antigen test. <br/ ><br>COVID -19 patients admitted between June 2020 and September 2020 <br/ ><br>Patients above 18 years admitted to hospital or critical care unit and on oxygen therapy, non-invasive ventilation (NIV) or invasive mechanical ventilation (IMV)→ | Exclusion criteria: Patients with pre-existing liver disorders. <br/ ><br>2. Patients with any prior hypoalbuminemic state. <br/ ><br>3. Patients with hematological malignancies, immunocompromised states. <br/ ><br>4. Patients with fluid resuscitations where the serum albumin level couldbe altered. <br/ ><br>5. patients with trauma,extensive bowel resection,burns <br/ ><br>6. Patients with AKI or CKD with possible albumin loss in urine→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Correlation of CAR, NAR, CXR score after administration of remdesivir. SpO2, PaO2, FiO2, Pao2/Fio2 will be evaluated.Timepoint: Correlation of CAR, NAR, CXR score,at baseline and after 48hrs,72hrs,5days post administration of remdesivir. SpO2, PaO2, FiO2, Pao2/Fio2 will be evaluated at baseline and 48hrs,72hrs,5 days post administration of remdesivir→ | | | | Yes | False | | |
| → | CTRI/2020/11/029289 | 27 January 2021 | A clinical trial of Siddha drugs M V kashayam (Internally) for the management and treatment of COVID 19 | A prospective non randomized single arm, single center clinical study to evaluate the effectiveness of Siddha medicine M V Kashayam in the management and treatment of COVID 19 patients | | Arul Anandar College | 23-11-2020 | 20201123 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48077 | Not Recruiting | No | | | | 25-11-2020 | 130 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:An Open list of random numbers Blinding and masking:Outcome Assessor Blinded | Phase 2/ Phase 3 | India→ | Dr P Dharumarajan→ | | Government Hospital
Aruppukottai 626101 11, Telephone Road,
Aruppukottai 626101→ | harsanasiddhamm@gmail.com→ | 9442355686→ | Government Hospital→ | Inclusion criteria: Inclusion criteria <br/ ><br>1. Patients with positive RT- PCR test <br/ ><br>2. The age group of 15 yrs to 60 yrs. <br/ ><br>3. Patients with mild and moderate symptoms of COVID 19. <br/ ><br>4. Patients of both sex and willing to accept the treatment method. <br/ ><br> <br/ ><br>Withdrawal Criteria <br/ ><br>i) Intolerance to the drug and development of any serious adverse effect during a drug trial. <br/ ><br>ii) Poor patient compliance & defaulters <br/ ><br>iii) Patient is unwilling to continue the course of clinical Study. <br/ ><br>iv) The occurrence of any other systemic illness. <br/ ><br>→ | Exclusion criteria: i.RT- PCR negative patients <br/ ><br>ii.Patients of less than 15 yrs and above 60 yrs of age. <br/ ><br>iii.Pregnant and breastfeeding women. <br/ ><br>iv.Patients with severe COVID 19 symptoms. <br/ ><br>v.Allopathic Antiviral treatment patients. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: MV kashayam: The kashayam has prepared with multi herbs combination and study its efficacy in curing the COVID 19 patients at the dose rate of 150 ml for every six hours interval for 6 days<br>Control Intervention1: M V kashayam vs conventional medicine: The drug conventional Siddha medicine comprising of multiple herbs, 50 g of herbal boiled in 600 ml of water and reduced to 150 ml and at the dosage of 150ml per patient at 6hours intervals for the period of 5 days.<br>Control Intervention2: MV kashayam: Multi herbal combination<br>Control Intervention3: Vitamin C and Zinc sulphate: Vitamin C at the dose rate of 100mg and Zine tab at the dose rate of 200 mg per day per patient<br>→ | The medicine for Prophylactic and treatment of COVID 19 based on RT-PCR negative, CRPTimepoint: 12 weeks (3 months)→ | | | | Yes | False | | |
| → | CTRI/2020/11/029297 | 27 January 2021 | Changing Trends in Presentation of Trauma Patients during Nationwide lockdown for COVID 19 | Changing Trends in Presentation of Trauma Patients during Nationwide lockdown for COVID 19 in a Tertiary Care Hospital in Mumbai. | | None | 23-11-2020 | 20201123 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47331 | Not Recruiting | No | | | | 01-12-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Vipul Versi Nandu→ | | Department of General Surgery,
HBT Medical College and Dr. R. N. Cooper Hospital, Juhu, Vile-Parle, Mumbai. Department of General Surgery,
HBT Medical College and Dr. R. N. Cooper Hospital, Juhu, Vile-Parle, Mumbai.→ | dr.vipulnandu@gmail.com→ | | HBT Medical College and Dr. R.N. Cooper Hospital→ | Inclusion criteria: 1.Hospitalized trauma patients with injuries <br/ ><br>2.Patients of all age groups <br/ ><br>→ | Exclusion criteria: 1.Patient who had to be transferred to other hospitals for further management <br/ ><br>2.Patient who were dead on arrival were also excluded from the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: T07- Unspecified multiple injuries
→ | | Data on Trauma PresentationsTimepoint: At the time of admission, after 24 hours, and at the time of discharge→ | | | | Yes | False | | |
| → | CTRI/2020/11/029305 | 27 January 2021 | Clarithromycin in Post Covid 19 parenchymal organizing pneumonia | Clarithromycin in post Covid parenchymal organizing pneumonia - an open labelled randomized control trial - PCOVID | | SELF DrIrfan Ismail Ayub | 24-11-2020 | 20201124 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48195 | Not Recruiting | No | | | | 25-11-2020 | 120 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Irfan Ismail Ayub→ | | Department of Pulmonary Medicine, Sri Ramachandra Institute of Higher Education and Research, No 1 Ramachandra Nagar, Porur, Chennai → | irfanismailayub@gmail.com→ | 9884282400→ | Sri Ramachandra Institute of Higher Education and Research→ | Inclusion criteria: 1. All patients diagnosed with COVID 19 based on positive result on SARS-CoV2 RT-PCR or CBNAAT from nasopharyngeal or oropharyngeal swab or secretions. <br/ ><br>2. More than two weeks, but less than six weeks have lapsed after the above diagnostic positive result. <br/ ><br>3. A repeat nasopharyngeal or oropharyngeal swab test (either SARS-CoV2 RT-PCR or CBNAAT) performed at two weeks or later, after earlier positive result, is now negative. <br/ ><br>4. CT scan of thorax performed after two weeks and less than six weeks after the first positive result, shows features of organizing pneumonia. <br/ ><br> <br/ ><br>Organizing pneumonia on CT scan of thorax is diagnosed when, one or more of the following features are identified on the CT scan images of thorax: <br/ ><br>1.Unilateral or bilateral basal subpleural lobar, segmental or perilobular consolidation <br/ ><br>2.Halo sign <br/ ><br>3.Reverse halo sign or atoll sign <br/ ><br>4.Target sign or bulls-eye sign or double halo sign <br/ ><br>→ | Exclusion criteria: 1.Patient is unwilling to provide consent <br/ ><br>2.Patients with preexisting parenchymal or interstitial lung disease <br/ ><br>→ | Health Condition 1: J840- Alveolar and parieto-alveolar conditions
Health Condition 2: J128- Other viral pneumonia
→ | Intervention1: Oral Clarithromycin 500 mg PO one tablet BiD for three months: Oral Clarithromycin 500 mg PO one tablet BiD for three months<br>Intervention2: Oral Clarithromycin 250 mg PO one tablet BiD for three months: Oral Clarithromycin 250 mg PO one tablet BiD for three months<br>Control Intervention1: No intervention: No intervention<br>→ | Percentage of patients with complete resolution of lung findings at third month of follow up.Timepoint: Three months of follow up→ | | | | Yes | False | | |
| → | CTRI/2020/11/029328 | 27 January 2021 | A phase II study to evaluate safety and effectiveness of IND02 Capsules in patients who are hospitalized SARS-CoV2 positive patients with mild to moderate COVID-19 at COVID management centres offering Ayurvedic care. | A prospective, interventional, randomized, double-blind, placebo-controlled
study to evaluate the safety and effectiveness of IND02 capsules (Cinamuneâ?¢) in hospitalized SARS-CoV2 positive patients with mild to moderate COVID-19, managed as per the Government of India COVID-19 management guidelines, at COVID-19 management centres offering integrated Ayurvedic care.
| | Indus Biotech Private Limited | 24-11-2020 | 20201124 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49552 | Not Recruiting | No | | | | 30-11-2020 | 118 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 2 | India→ | Suneela Thatte→ | | Natraj by Rustomjee 6th Floor, 194 MV Road, Near Western Express Highway Metro Station
Andheri East, Mumbai → | suneela.thatte@iqvia.com→ | 912266774242→ | IQVIA RDS (India) Private Limited→ | Inclusion criteria: 1. Male or Female with â?¥ 18 years and < 60 years of age, willing and able to provide written informed consent for participation in the study and ready to comply with the study procedures and schedule. <br/ ><br>2. Patient with confirmed diagnosis for COVID-19, and who has tested positive for infection with SARS-CoV2 virus. <br/ ><br>Note: COVID-19 infection confirmed by RT-PCR following ICMR/WHO protocol in â?¤ 5 days prior to randomization in the study. <br/ ><br>3. Patient is requiring hospitalisation for COVID-19 at the time of randomization in the study. <br/ ><br>4. Patient with WHO Clinical Progression Scale score of 3 to 5 <br/ ><br>→ | Exclusion criteria: 1. Patients with a known history of allergy or intolerance to Cinnamon. <br/ ><br>2. Participation in another concurrent clinical trial for COVID-19 or in any other trial within the 6 months prior to this study enrolment. <br/ ><br>3. Patients classified as severe or critical COVID-19 patients as per AYUSH guidelines. <br/ ><br>4. Patients with pre-existing respiratory conditions, or with severe primary respiratory disease or other pneumonia, who may not be eligible for enrolment in the study as per the Investigatorâ??s opinion. <br/ ><br>5. Patients with other serious diseases such as cancer, heart disease, stroke, disabilities, mental illnesses, etc., who may not be eligible for enrolment in the study as per the Investigatorâ??s opinion. <br/ ><br>6. Patients requiring mechanical ventilation at screening. <br/ ><br>7. Patients with uncontrolled and unstable comorbid conditions. <br/ ><br>8. Immunocompromised individuals or patients who are already receiving immunosuppressant therapies. <br/ ><br>9. Patients who are currently on or may require parenteral nutrition during the course of the study. <br/ ><br>10. Female patients who are breastfeeding or pregnant at the time of enrolment in the study. <br/ ><br>11. Female patients of childbearing potential who, within 4 weeks prior to study enrolment, did not use a highly effective method of contraception or do not agree to use a highly effective method of contraception throughout the study period. <br/ ><br>12. Any medical or other condition that in the opinion of the Investigator would preclude the patientâ??s participation in the study. <br/ ><br>13. Current abuse of alcohol; and current or past (last 12 months) abuse of drugs. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Study Drug: IND02 [Cinamuneâ?¢] capsules 500 mg <br><br>Placebo: Placebo capsules 500 mg (containing all excipients except active ingredient) to be provided by Indus Biotech Pvt. Ltd., India.<br>: Patients with receive either the Test or the Placebo product as per the dosing regimen below (along with SoC treatment):<br>â?¢ Loading dose: 3 g/day [2 capsules of 500 mg X 3 times] for initial 3<br>â?¢ days<br>â?¢ Maintenance dose: 1.5 g/day [ 1 capsule of 500 mg X 3 times] fornext 12 days<br><br>Intervention2: IND02 [Cinamuneâ?¢] capsules 500 mg <br><br>: Patients with receive either the Test or the Placebo product as per the dosing regimen below (along with SoC treatment): - Loading dose: 3 g/day [2 capsules of 500 mg X 3 times] for initial 3 - days - Maintenance dose: 1.5 g/day [ 1 capsule of 500 mg X 3 times] fornext 12 days<br>Control Intervention1: Placebo capsules 500 mg (containing all excipients except active ingredient) to be provided by Indus Biotech Pvt. Ltd., India.: Patients with receive either the Test or the Placebo product as per the dosing regimen below (along with SoC treatment):<br>- Loading dose: 3 g/day [2 capsules of 500 mg X 3 times] for initial 3<br>- days<br>- Maintenance dose: 1.5 g/day [ 1 capsule of 500 mg X 3 times] fornext 12 days<br><br>→ | - Median time to recovery using WHO Clinical Progression Scale between the test and placebo groupsTimepoint: From date of randomization until 15 days of treatment and <br/ ><br>additional 7 days of follow-u <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/11/029335 | 27 January 2021 | Apprehensions and Challenges faced by dentists during Covid 19 pandemic | Apprehensions and Challenges faced by dentists during Covid 19 pandemic - Questionnaire based study | | Muskaan Chichra | 24-11-2020 | 20201124 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49555 | Not Recruiting | No | | | | 02-12-2020 | 189 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Muskaan Chichra→ | | Department of Oral Pathology and Microbiology
Manipal College of Dental Sciences, Manipal Manipal College of Dental Sciences
Madhav Nagar, Eshwar Nagar, Manipal, Karnataka
576104→ | sunitha.carnelio@manipal.edu→ | 9449257614→ | Manipal College of Dental Sciences, Manipal→ | Inclusion criteria: Subjects voluntarily taking part in the study <br/ ><br>Subjects who are certified to perform dental procedures <br/ ><br>Subjects who have resumed with their dental practice→ | Exclusion criteria: Subjects who refuse to take part in the study <br/ ><br>Subjects who are not certified to perform dental procedures→ | | | Apprehensions and challenges faced by dentists during Covid 19 pandemic based on questionnaireTimepoint: cross sectional→ | | | | Yes | False | | |
| → | CTRI/2020/11/029356 | 27 January 2021 | A clinical study to compare high flow nasal oxygen and non invasive ventilation in patients with covid-19. | COMPARISON USE OF HIGH-FLOW NASAL CANNULA AND NON INVASIVE VENTILATION IN PATIENTS WITH COVID-19: A RANDOMIZED COMPARATIVE STUDY | | BLDEDU | 25-11-2020 | 20201125 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49432 | Not Recruiting | No | | | | 25-11-2020 | 82 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Pratibha S D→ | | SHRI B M PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTER, BLDEDU, DEPARTMENT OF ANAESTHESIA
BANGARAMMA SAJJAN CAMPUS, BLDE, VIJAYAPURA, KARNATAKA SHRI B M PATIL MEDICAL COLLEGE, HOSPITAL AND RESEARCH CENTER,
BANGARAMMA SAJJAN CAMPUS, BLDE, VIJAYAPURA,→ | pratibhakaradi@gmail.com→ | 9036110082→ | BLDEU bijapur→ | Inclusion criteria: Patients with COVID-19 rtPCR positive who requires HFNO and NIV as first line therapy. <br/ ><br>Patients aged between 20-60years and weighing 40-80kg. <br/ ><br>→ | Exclusion criteria: Patients with <br/ ><br>pH < 7.20 <br/ ><br>Children <br/ ><br>Comorbidities like renal, cardiac and liver failure and morbid obesity. <br/ ><br>→ | Health Condition 1: J09X- Influenza due to identified novelinfluenza A virus
Health Condition 2: J09X- Influenza due to identified novelinfluenza A virus
Health Condition 3: J22- Unspecified acute lower respiratory infection
→ | Intervention1: HFNC AND NIV: HIGH FLOW NASAL CANNULA AND NON INVASIVE VENTILATION IN PATIENTS WITH COVID-19 AND HEMODYNAMIC STABILITY<br>Control Intervention1: HFNC AND NIV: TO COMPARE HFNC AND NIV AS FIRST LINE OF TREATMENT IN RESPIRATORY DISTRESS IN COVID -19 PATIENTS<br>→ | Reduction in respiratory distress signs like decrease in respiratory rate and increase in saturation SpO2 90%. <br/ ><br> Improvement in hemodynamic stability such as Heart rate, respiratory rate and blood pressure. <br/ ><br>Timepoint: ON ADMISSION <br/ ><br>6 HOURS <br/ ><br>12 HOURS <br/ ><br>24 HOURS <br/ ><br>2ND DAY <br/ ><br>4TH to 6TH DAY <br/ ><br>1ST WEEK→ | | | | Yes | False | | |
| → | CTRI/2020/11/029346 | 27 January 2021 | Spectrum of eye infections in COVID-19 affected individuals | Spectrum of posterior uveitis and endophthalmitis in patients with COVID-19. | | LV PRASAD EYE INSTITUTE | 25-11-2020 | 20201125 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48444 | Not Recruiting | No | | | | 26-11-2020 | 20 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrSameera Nayak→ | | Clinical Research department, , Ground floor near waiting hall 1 ,L.V Prasad Eye Institute ,Kode Venkatadri Chowdary campus ,Tadigadapa,Vijayawada -521137,Andhra Pradesh. → | sameera@lvpei.org→ | 9390513748→ | L.V Prasad eye institute→ | Inclusion criteria: All patients with COVID-19 RT PCR positive for nasal swab, presenting with clinical features of posterior uveitis or endophthalmitis will be included in this study.→ | Exclusion criteria: Those who are COVID RT-PCR negative in their nasal swab are excluded from the study. Those who are positive for rapid antigen test but negative for COVID RT-PCR in their nasal swab are also excluded from the study. <br/ ><br>→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: O- Medical and Surgical
Health Condition 4: H438- Other disorders of vitreous body
→ | Intervention1: Pars plana vitrectomy with intraocular antibiotic injection: All patients with COVID-19 RT-PCR positive for their nasal swab and having inflammation in vitreous body/retina or uvea will be included. At presentation a detail eye examination will be done which will include visual acuity measurement, intra-ocular pressure measurement, cornea, lens, vitreous, retina examination, peri-ocular tissue examination. Photographic documentation of eye examination will be done whenever appropriate. After a detail eye examination diagnosis of the inflammation in the form of endophthalmitis/panophthalmitis/uveitis will be done depending on the extend of inflammation. Systemic broad spectrum antibiotic, NSAID(Non steroidal anti inflammatory drugs) will be advised. Topical broad spectrum antibiotic, steroid, cycloplegic will be instilled. A vitreous biopsy will be done and the sample will be sent for detail microbiological assay which includes smear and culture of the specimen. Additional surgical intervention like attaching the retina with silicone oil, clearing exudation from vitreous cavity, drainage of abscess from peri-ocular tissue will be done as per the eye condition. Empirical intra-vitreal antibiotic will be injected inside the vitreous cavity after taking biopsy sample. After confirming the organism as per the sensitivity report, systemic, topical and intra-vitreal antibiotic will be changed. A comprehensive eye examination will be done in each visit to know and document the response of the treatment. If infection is profuse and eye ball is not salvageable then ocular contents will be removed by evisceration technique.<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | The primary outcome of this study will be type of organism found in the vitreous sampleTimepoint: To achieve the primary end point 2 weeks period will be required from the date of presentation.→ | | | | Yes | False | | |
| → | CTRI/2020/11/029345 | 27 January 2021 | To determine efficacy, safety and optimal dosing of anticoagulant strategies to prevent adverse outcomes in hospitalized COVID-19 patients.
| A Phase IV Prospective Multi-Center, Open Label, Randomized Controlled Comparative Study to evaluate the safety and effectiveness of enoxaparin and apixaban in patients hospitalized (but not yet intubated) with confirmed COVID-19. | | Icahn School of Medicine at Mount Sinai | 25-11-2020 | 20201125 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48213 | Not Recruiting | No | | | | 25-11-2020 | 3600 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Other Blinding and masking:Open Label | Phase 4 | Brazil;India;Mexico;United States of America→ | Dr Viral Shah→ | | 401, 4th Floor Kshamalaya Building, 37 New Marine Lines.
Mumbai
MAHARASHTRA
400020
India
→ | vshah@spectrumcr.com→ | 02240645101→ | Spectrum Clinical Research Pvt Ltd→ | Inclusion criteria: 1. Hospitalization within the prior 24 hours for either confirmed <br/ ><br>(based on PCR or antigen positive test for SARS-CoV-2) or <br/ ><br>suspected COVID-19 based on 3 criteria (all 3 must be <br/ ><br>present for suspected cases): <br/ ><br>a. Fever >38 degrees Celsius <br/ ><br>b. O2 saturation â?¤94 <br/ ><br>c. Abnormal laboratory marker (at least 1) <br/ ><br>i. d-dimer â?¥1.0 μg /mL <br/ ><br>ii. CRP >2 mg/L <br/ ><br>iii. Ferritin >300 μg /L <br/ ><br>iv. Lymphopenia <1500 cells /m3 <br/ ><br>2. Patient or legal guardian provides written informed consent→ | Exclusion criteria: 1. Age <18 years <br/ ><br>2. Mechanical ventilation on admission or high likelihood for the <br/ ><br>need for invasive mechanical ventilation within 24 hours of <br/ ><br>admission <br/ ><br>3. Anticipated duration of hospital stay <72 hours <br/ ><br>4. Treatment with therapeutic dose UFH or LMWH, vitamin K <br/ ><br>antagonists, or NOACs within seven days <br/ ><br>5. Active bleeding <br/ ><br>6. Risk factors for bleeding <br/ ><br>a. intracranial surgery or stroke within 3 months <br/ ><br>b. history of intracerebral arteriovenous malformation <br/ ><br>c. cerebral aneurysm or mass lesions of the central <br/ ><br>nervous system <br/ ><br>d. intracranial malignancy <br/ ><br>e. history of intracranial bleeding <br/ ><br>f. history of bleeding diatheses (e.g., hemophilia) <br/ ><br>g. history of gastrointestinal bleeding within previous 3 <br/ ><br>months <br/ ><br>h. thrombolysis within the previous 7 days <br/ ><br>i. presence of an epidural or spinal catheter <br/ ><br>j. recent major surgery <14 days <br/ ><br>k. uncontrolled hypertension (sBP > 200 mmHg or dBP > <br/ ><br>120 mmHg) <br/ ><br>l. other physician-perceived contraindications to <br/ ><br>anticoagulation <br/ ><br>m. Platelet count <50 x109/L, INR >2.0, or baseline aPTT <br/ ><br> >50 seconds <br/ ><br>n. Hemoglobin <80 g/L (to minimize the likelihood of <br/ ><br>requiring red blood cell transfusion if potential bleeding <br/ ><br>were to occur) <br/ ><br>o. current treatment with antithrombotics or antiplatelet <br/ ><br>agents <br/ ><br>7. Acute or subacute bacterial endocarditis <br/ ><br>8. History of heparin induced thrombocytopenia (HIT) or other <br/ ><br>heparin allergy including hypersensitivity <br/ ><br>9. Patients with non-COVID-19 related clinical condition for <br/ ><br>which life expectancy is <6 months <br/ ><br>10. Pregnancy (women of childbearing potential are required to <br/ ><br>have a negative pregnancy test prior to enrollment) <br/ ><br>11. Active enrollment in other trials related to anticoagulation <br/ ><br>12. Patients has end stage kidney disease (ESKD) on chronic <br/ ><br>dialysis <br/ ><br>13. Patient is a member of a vulnerable population: In the <br/ ><br>judgment of the investigator the patient is unable to give <br/ ><br>Informed Consent for reasons of incapacity, immaturity, <br/ ><br>adverse personal circumstances or lack of autonomy. This <br/ ><br>may include: Individuals with mental disability, persons in <br/ ><br>nursing homes, children, impoverished persons, persons in <br/ ><br>emergency situations, homeless persons, nomads, refugees, <br/ ><br>and those incapable of giving informed consent. Vulnerable <br/ ><br>populations also may include members of a group with a <br/ ><br>hierarchical structure such as university students, subordinate <br/ ><br>hospital and laboratory personnel, employees of the Sponsor, <br/ ><br>members of the armed forces, and persons kept in detention.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: Prophylactic enoxaparin: 40 mg SC QD; 30 mg SC QD for<br>CrCl 30 mL /min<br><br>Control Intervention2: Full dose enoxaparin: 1 mg/kg SC Q12h; 1 mg/kg SC QD for CrCl 30 mL /min<br>Control Intervention3: Apixaban: 5 mg Q12h; 2.5 mg Q12h for patients with at least<br>two of three of age â?¥80 years, weight â?¤60 kg or s. creatinine<br>â?¥1.5 mg/dL<br>→ | â?? Effectiveness â?? The primary effectiveness outcome endpoint <br/ ><br>is the time to first event rate within 30 days of randomization of <br/ ><br>the composite of all-cause mortality, intubation requiring <br/ ><br>mechanical ventilation, systemic thromboembolism (including <br/ ><br>pulmonary emboli) confirmed by imaging or requiring surgical <br/ ><br>intervention OR ischemic stroke confirmed by imaging <br/ ><br>â?? Safety â?? The primary safety outcome endpoint is the in-hospital <br/ ><br>rate of BARC 3 or 5 bleeding (binary)Timepoint: within 30 days of randomization→ | | | | Yes | False | | |
| → | CTRI/2020/11/029350 | 27 January 2021 | Assessing the knowledge and precautions taken by dentists and dental auxiliaries(operating, non-operating) in dental office during the pandemic of Corona virus (COVID-19) | Assessing the awareness and precautions taken by dentists and dental auxiliaries in dental office during the pandemic of COVID-19 | | NIL | 25-11-2020 | 20201125 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49535 | Not Recruiting | No | | | | 01-12-2020 | 108 | Observational | Single Arm Trial<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | Phase 2/ Phase 3 | India→ | Dr Deepak Kumar Singhal→ | | Department of Public Health Dentistry, Manipal College of Dental Sciences, Manipal. Room number:08 → | dk.singhal@manipal.edu→ | 9379060983→ | Manipal College of Dental Sciences, MAHE, Manipal→ | Inclusion criteria: 1. All the dentists and dental auxiliaries working <br/ ><br> in clinical branches only <br/ ><br>2. Consent given by eligible participants <br/ ><br>3. Those who can read and write English <br/ ><br>→ | Exclusion criteria: 1. Dental staff who are infected or quarantined <br/ ><br>2. The staff who are not willing to participate <br/ ><br>→ | | | Evaluation of the awareness and precautions taken by dentists and dental auxiliariesTimepoint: 1 year→ | | | | Yes | False | | |
| → | CTRI/2020/11/029396 | 27 January 2021 | Safety of an aerosol having as its active ingredient 8.4 % sodium bicarbonate and xylitol 5% when administered to the nasopharynx and oropharynx | A prospective, open label, single arm consumer research to study the safety and tolerability of an aerosol having as its active ingredient 8.4 % sodium bicarbonate, when administered to the nasopharynx and oropharynx; and to assess the preventive strength of the aerosol against the development of Influenza Like Illness (ILI) including the Covid-19 infection in the general as well as high risk population. | | Myself Health Check Ltd | 26-11-2020 | 20201126 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49442 | Not Recruiting | No | | | | 01-12-2020 | 325 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Vidhi Hingu→ | | Welcare Hospital,
Near Mercedes Showroom,
Atladara-Vadsar Ring Road,
Atladara, Vadodara → | drkshitijmody@welcarehospital.co.in→ | 0265-2337172→ | Welcare Hospital→ | Inclusion criteria: 1) Age: For adult 18 years and above at the time of consent. <br/ ><br>2) Sex: For adult, Healthy male and Non-pregnant/non-lactating females, <br/ ><br>3) Females of childbearing potential and menarche children both must have a negative urine pregnancy test performed on screening visit. <br/ ><br>4) Use effective contraception (see below) for the duration of the trial period (females only) <br/ ><br>5) Subjects are in good general health as determined by the Investigator on the basis of medical history reported by subjects, including absence of any symptoms/signs of covid-19 infection or any other ILI. <br/ ><br>6) Subjects must be able to understand and provide written informed consent to participate in the study. <br/ ><br>7) Chest radiograph normal <br/ ><br>8) No relevant findings in medical history or on physical examination <br/ ><br>9) Able and willing to comply with all the trial requirements→ | Exclusion criteria: 1) Pregnant or lactating female subjects should be excluded as these conditions impact the condition of the skin. <br/ ><br>2) Clinically significant history of skin disorder, allergy, atopy, immunodeficiency (including HIV), cancer (except BCC or CIS), cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, neurological illness, psychiatric disorder, drug or alcohol abuse. <br/ ><br>3) Subjects who have a clinically significant active Oral Cavity and Nasal disease. <br/ ><br>4) Subjects who have a history of recent Oral or Nasal Surgery or ongoing treatment. <br/ ><br>5) Subjects who have a condition or are taking medication(s) which, in the judgment of the Investigator or Designate, makes the subject ineligible or places the subject at undue risk. <br/ ><br>6) Subjects who have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months. <br/ ><br>7) Subjects who have history of an autoimmune or immune deficiency disease (e.g. lupus, myositis, Crohns disease, autoimmune thyroid diseases, autoimmune hepatitis, etc.). <br/ ><br>8) Subjects who are currently taking any immunosuppressant medication. <br/ ><br>9) Subjects who have history of insulin-dependent diabetes. <br/ ><br>10) Subjects who have history of asthma or any other chronic respiratory condition requiring daily therapy. <br/ ><br>11) Subjects who are currently taking/using any antihistamines or systemic/topical anti-inflammatory medications (e.g. ibuprofen, corticosteroid, etc.) on a routine or frequent basis. <br/ ><br>12) Subjects who are currently receiving allergy injections, expects to start injections before the conclusion of the study or has had the final injection within a week of the study start. <br/ ><br>13) Subjects who are currently participating in any another study related to Oral and Nasal applications. <br/ ><br>14) Subjects who are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study. <br/ ><br>15) Subjects who have a known sensitivity or allergy relating to the substance(s) being evaluated. <br/ ><br>16) Pregnancy, lactation or intention to become pregnant during trial period Any respiratory disease, including asthma <br/ ><br>17) Any nasal, pharyngeal, or laryngeal finding which precludes bronchoscopy <br/ ><br>18) Past treatment for TB disease <br/ ><br>19) Subjects who are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study.→ | | Intervention1: A solution containing 8.4% Sodium Bicarbonate & 5% Xylitol along with other excipients: NASAL SPRAY -<br><br>Sodium Bicarbonate 8.4 %<br>Glycerine 8.0%<br>Propylene glycol 5.0%<br>Xylitol 5.0%<br>Benzalkonium chloride 0.01%<br>Strawberry Flavour 0.01%<br>Neotam Sweetener QS<br>Water <br><br><br><br>ORAL SPRAY -<br><br>Sodium Bicarbonate 8.4 %<br>Glycerine 20.0%<br>Propylene glycol 5.0%<br>Xylitol 5.0%<br>Benzalkonium chloride 0.01%<br>Polo mint Flavour 0.04%<br>Neotam Sweetener QS<br>Brilliant blue QS<br>Water<br>.<br>.<br>.<br>Duration of therapy - 28 days...<br>Frequency of therapy - 4 times Daily<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | To assess the preventive strength of the aerosol containing as its active ingredient 8.4 % sodium bicarbonate when administered to the nasopharynx and oropharynx against the development of Influenza Like Illness (ILI) including Covid-19 infection in the general as well as high risk population as assessed by the proportion of subjects not getting ILI symptoms at the end of the study using the FLU-Pro Plus Patient Reported Outcome Measure (PROM).Timepoint: 28 days→ | | | | Yes | False | | |
| → | CTRI/2020/11/029399 | 27 January 2021 | Develop homeopathic Nosodes for Immunity Against COVID 19. | Development of homeopathic nosode from Covid-19, itâ??s evaluation and efficacy against Covid-19 infections in humans | | CENTRAL COUNCIL FOR RESEARCH IN HOMEOPATHY Ministry of AYUSH | 26-11-2020 | 20201126 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49714 | Not Recruiting | No | | | | 10-12-2020 | 20 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 1 | India→ | Dr Naval Kumar Verma→ | | J-13/34, Patel Market, Rajouri Garden → | anil23101961@gmail.com→ | 9911127619→ | Central Council for Research in Homoeopathy (CCRH)→ | Inclusion criteria: Hospitalized patients with confirmed COVID-19 infection <br/ ><br>Age between 18 years to 80 years of both gender <br/ ><br>Willing to give signed written informed consent <br/ ><br>→ | Exclusion criteria: Patients on ventilator support <br/ ><br>Immuno-compromised patients <br/ ><br>Severe heart, lung, kidney, brain, blood diseases or other important systemic diseases <br/ ><br>Subjects considered to be unable to complete the study, or not suitable for the study by researchers. <br/ ><br>Women during pregnancy <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NOSODE: Nosode in current methodology<br>to develop a protective medicine<br>to help patient infected with<br>newly emerged virusCovid-19.<br>In Homeopathy method, using<br>various plants, metals or salts<br>are extracted (Tincture) and<br>further potentized by specific<br>method of shaking in alcohol<br>and not simple dilution, to the<br>level of 6C-106, 30 C-1030, 200<br>C-10200 and further<br>Control Intervention1: Standard care for covid 19<br>patients: The standard care treatment<br>that will be given to the patients<br>in hospital<br>→ | To study the safety, effects and feasibility of the prepared Nosodes and â??Control Nosodeâ?? with different potency (6, 30, 200 etc) in treatment of Covid-19 in animal model. <br/ ><br>To study and determine safe dose in healthy individuals in Phase.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/11/029393 | 27 January 2021 | Eye Diseases associated with COVID-19 | Screening for Retinopathy in Patients with COVID-19 - NIL | | Lilavati Hospital | 26-11-2020 | 20201126 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48183 | Not Recruiting | No | | | | 30-11-2020 | 30 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Salil Mehta→ | | A791
Bandra Reclamation
Bandra
Mumbai A791
Bandra Reclamation
Bandra
Mumbai→ | drsalilmehta@gmail.com→ | 022-26568229→ | Lilavati Hospital and Research Center→ | Inclusion criteria: 1. All patients admitted with a RT-PCR proven COVID-19 infection <br/ ><br>2. Discharged recovered patients→ | Exclusion criteria: NIL→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: H308- Other chorioretinal inflammations
Health Condition 4: H309- Unspecified chorioretinal inflammation
→ | Intervention1: NIL: NIL<br>→ | 1. Detection of retinal/choroidal lesions using fundus photography/Optical coherence tomography <br/ ><br>Timepoint: 1. At any time during admission or immediate post-discharge <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/11/029398 | 27 January 2021 | Palliative Care in COVID-19 | Retrospective audit of outcomes of palliative care referral in patients with serious COVID-19 illness | | Kasturba Medical College and Hospital | 26-11-2020 | 20201126 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49741 | Not Recruiting | No | | | | 07-12-2020 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Seema Rajesh Rao→ | | Department of Palliative Medicine and Supportive Care,
Tiger Circle Road, Madhav Nagar → | uskpsy69@gmail.com→ | 09892336650→ | Kasturba Medical College and Hospital, Manipal→ | Inclusion criteria: Patients with serious COVID-19 illness referred to palliative care up to October 31, 2020→ | Exclusion criteria: Patients with serious COVID-19 illness below 18 years of age→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B998- Other infectious disease
→ | | a. Evaluate the outcomes of palliative care referral in patients with serious COVID-19 illnessTimepoint: On admission→ | | | | Yes | False | | |
| → | CTRI/2020/11/029377 | 27 January 2021 | Formative research for management of serious infections in infants less than 2 months of age during COVID pandemic | Formative Research for
Management of Possible Serious Bacterial Infection (PSBI) during COVID pandemic
- PSBI FR | | Centre for Health Research and Development Society for Applied Studies | 26-11-2020 | 20201126 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49498 | Recruiting | No | | | | 15-12-2020 | 70 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sarmila Mazumder→ | | 45 Kalu Sarai, New Delhi
→ | sarmila.mazumder@sas.org.in→ | 011-46043751-55→ | Centre for Health Research and Development, Society For Applied Studies→ | Inclusion criteria: Program managers, health care providers, community health workers, caregivers of the young infants, community informants.→ | Exclusion criteria: Only those who do not give consent.→ | | | Identify the barriers and enablers for management of PSBI in young infants since pre-covid, period till the current times and identify possible mitigation strategies to improve treatment of PSBI.Timepoint: End study at 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/11/029414 | 27 January 2021 | COVID WITH AKI | STUDY OF HOSPITALIZED COVID-19 PATEINTS WITH SPECIAL REFERENCE TO ACUTE KIDNEY INJURY | | NA | 26-11-2020 | 20201126 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49245 | Not Recruiting | No | | | | 14-12-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DR NEHAL M SHAH→ | | GENERAL MEDICINE DEPARTMENT , FIRST FLOOR, SARDAR VALLABHBHAI PATEL INSTITUTE OF MEDICAL SCIENCE AND RESEARCH SMT.NHL MUNICIPAL MEDICAL COLLEGE , ELLISBRIDGE ,
→ | desaiishan99@gmail.com→ | 9978148241→ | SMT. NHL MUNICIPAL MEDICAL COLLEGE→ | Inclusion criteria: INPATIENTS IN GENERAL MEDICINE WITH A NEWLY DIAGNOSED CASE OF COVID 19 WITH AKI AS PER KDIGO CRITERIA <br/ ><br> <br/ ><br>PATIENTS/THEIR RELATIVES WHO ARE WILLING TO GIVE THEIR INFORMED CONSENT→ | Exclusion criteria: PRE EXISTING CASE OF CKD <br/ ><br>PATIENTS ALREADY ON MAINTENANCE HEMODIALYSIS OTHER CAUSES OF AKI SUCH AS : POST RENAL CAUSES OF AKI→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | DEATH <br/ ><br>DISCHARGETimepoint: At baseline, every 3rd day till Discharge/ Death→ | | | | Yes | False | | |
| → | CTRI/2020/11/029388 | 27 January 2021 | Pirdal Nasal Spray in preventing symptomatic manifestation of disease in Covid-19 proven cases | A Randomized, Multicentrique, Single-Blind, Observational Pilot Study To Evaluate Efficacy And Safety Of Pirdal Nasal Spray In Preventing Symptomatic Manifestation Of Disease In Covid-19 Proven Cases. | | VITROBIO SAS | 26-11-2020 | 20201126 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49529 | Not Recruiting | No | | | | 27-11-2020 | 200 | Interventional | Cluster Randomized Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant Blinded | N/A | India→ | Dr S Sadgune→ | | Plot No 80, Sector 8, Koparkhairane Navi Mumbai,
India → | dr.sayalitarte@gmail.com→ | | Mudra Clincare→ | Inclusion criteria: 1 Male or Female patients detected positive for Covid 19 by RT-PCR test and who have no or slight nasal /respiratory clinical signs at the time of recruitment. <br/ ><br>2 The patients aged between 18-70 at the time of screening. <br/ ><br>3 Patients who agreed not to self- medicate with other potential preventive ARI-antivirals. ï?· Not currently symptomatic with an acute respiratory illness <br/ ><br>4 Patients with Cooperative and understanding skills. <br/ ><br>5 Patient willing to provide written informed consent. <br/ ><br>6 Patient able to have internet access each day of the study to complete the online questionnaire <br/ ><br>7 Patients ready to abstain from using any drug other than Investigational Product for the treatment of the studied condition, except in emergencies, in which case the responsible party must be immediately notified. Patients with moderate hypertension or diabetes may be included in the study.→ | Exclusion criteria: Patients, who will meet any of the exclusion criteria, will not be included in the study. <br/ ><br>1 Hypersensitivity/History of allergy to any of the investigational products componants <br/ ><br>2 Any recent nasal surgery <br/ ><br>3 Abnormal structural narrowing of sinus passages such as Deviated Nasal Septum or other kind of anatomical obstruction <br/ ><br>4 Any unstable, serious co-existing medical condition including, but not limited to, myocardial infarction, coronary bypass surgery, unstable angina, cardiac arrhythmias, clinically evident congestive heart failure, or cerebrovascular accident within 6 months prior to the Screening visit <br/ ><br>5 Clinical evidence of immunosuppression <br/ ><br>6 Patient under treatment of viral disease <br/ ><br>7 Patient with severe respiratory signs <br/ ><br>8 Patients +ve for serum antibodies <br/ ><br>9 Patients who have participated in other clinical studies less than 1 year prior to screening.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: PIRDAL Commercial name: â??COVISPRAY®: Indication: protecting and cleaning osmotic liquid nasal bandage to prevent respiratory distress.<br>(approx. 140 sprays).<br>Dose: 140 sprays<br>frequency route of administration: 2-3 sprays in each nostril<br>duration of therapy is 14 days.<br><br>→ | 1 To assess the change in the intensity of clinical symptoms (Nasal, general, coughing and respiratory) as per the Daily Questionnaire filled directly by the patients according to their randomization number <br/ ><br>2 The following symptoms will be scored for each patient: <br/ ><br>General: Fever, change in smell, taste appreciation, headache loss of taste, Nasal, Respiratory, Digestive <br/ ><br>3 To assess the number of patients in each group developing minor or severe clinical signsTimepoint: From baseline to post randomization visit on days 7 and 14.→ | | | | Yes | False | | |
| → | CTRI/2020/11/029394 | 27 January 2021 | Precautionary measure during surgical process during COVID-19 pandemic around the globe | Protection of health care workers from exhaled air of patients operated under local, regional, spinal or epidural anaesthesia during COVID 19 pandemic | | Dr Pradipkumar R Atodaria | 26-11-2020 | 20201126 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48280 | Not Recruiting | No | | | | 01-12-2020 | 30 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Pradipkumar Raghuvirsinh Atodaria→ | | Harsiddhi Cosmetic and Plastic Surgery Hospital, 306, Indraprastha, Sagrampura, sub jail cross road, Ring road, Surat,
Gujarat, India-395002
Unique Hospital-multispeciality and research institute, 102, Dept of Plastic surgery, Opp Kiran motor, Nr canal → | dratodaria@gmail.com→ | | Visiting plastic surgeon, Unique Hospital-multispeciality and research institute→ | Inclusion criteria: There is no any stringent criteria to select the patients. Acoording to plant surgery the patients were checked. Our study is just to observe the comfortness and effectiveness after implementing the strategy→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: Innovation technique, to prevent the (asymptomatic COVID-19)patientâ??s exhaled air from leaking into the OR, the invention describe the sealing the mask by taping it to the patientâ??s face.: The patients will be delivered oxygen through nasal prongs, covered with a sealed N-95/FFP-2 mask to the face for preventing escape of the exhaled air. A suction cannula can also inserted underneath the mask to provide suction of exhaled air. The opposite end of the suction tubing is passed through two sequential suction jars contain-ing hypochlorite solution and finally let outside the operation room. This theoretically helps to reduce the potential dispersal of virus from the exhaled air in the OR, thereby improving safety for surgical staff and at the same time provide oxygen by nasal prongs into the N-95/FFP-2 mask protect the patient from the (asymptomatic COVID-19)HCWs.<br>→ | The primary out to check the efficient of adopted technique. The above-described technique was made to divert the exhaled air from the patient to out-side the OR to avoid potential infection transmission from asymptomatic patients to health care workers (HCWs).Timepoint: Assessment carry out after 1 week; <br/ ><br>The above-described technique was made to divert the exhaled air from the patient to out-side the OR to avoid potential infection transmission from asymptomatic patients to health care workers (HCWs).→ | | | | Yes | False | | |
| → | CTRI/2020/11/029390 | 27 January 2021 | A study of clinical profile of children with COVID 19 INFECTION admitted at tertiary care hospital | A study of epidemiological and clinical features in children with COVID 19 INFECTION admitted at tertiary care hospital | | Smt NHL Municipal Medical College | 26-11-2020 | 20201126 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49606 | Not Recruiting | No | | | | 28-11-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DR Sweety Patel→ | | Department of Pediatrics
1st floor, C1 block
SVP Hospital Smt NHL Municipal Medical College
Ellis bridge, 380006→ | drashishbhojak@yahoo.in→ | 9426360234→ | Smt NHL Municipal Medical College→ | Inclusion criteria: Confirmed cases of COVID 19 INFECTION (BY RTPCR OR RAPID ANTIGEN TESTING) admitted at tertiary care hospital→ | Exclusion criteria: CHILDREN AGED LESS THAN 1 MONTH AND MORE THAN 12 YEARS→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Epidemiological and clinical featuresTimepoint: 28 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/11/029444 | 27 January 2021 | A clinical trial to study effect of Madhav Rasayan tablets in COVID 19 patients | An open label, randomized, parallel group, controlled, interventional clinical study to evaluate the efficacy and safety of â??Madhav Rasayanâ?? tablet as an adjuvant to Standard treatment in mild to moderate COVID-19 subjects - NIL | | Shri Vishwavati Ayurved Chikitsalaya and Research Centre | 27-11-2020 | 20201127 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49712 | Not Recruiting | No | | | | 03-12-2020 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Dr Tushar Saundankar→ | | Shri Vishwavati Ayurved Chikitsalaya and Research Centre run by Shri Vishwanath Maharaj Rukadikar Trust Vishwavati 697 B Shri Sadguru Rukadikar Maharaj Marg→ | research@shreevishwavati.com→ | 9867689658→ | Shree Vishwavati Ayurvedic Chikitsalaya & Research Centre→ | Inclusion criteria: 1. Gender: Either male or non-pregnant, non-lactating female aged > 18-60 < years (both inclusive). <br/ ><br>2. Subjects with RT-PCR confirmed diagnosis of COVID-19 <br/ ><br>3. Subjects with mild to moderate COVID-19 infection having Respiratory rate â?¥ 24/min and SpO2 > 90% on room air <br/ ><br>4. Subjects willing to give written informed consent <br/ ><br>5. Subjects able to take the drug orally and comply with the study protocol <br/ ><br>6. Women of child bearing potential must have a negative urine pregnancy test prior to study entry→ | Exclusion criteria: 1 Subjects with persistent vomiting <br/ ><br>2 Critically ill subjects <br/ ><br>3 Patient with Shock <br/ ><br>4 Subjects with known active hepatitis, tuberculosis <br/ ><br>5 Subjects with altered mental state if on medication <br/ ><br>6 Subjects with multiple organ failure requiring ICU monitoring and treatment <br/ ><br>7 Subjects with respiratory failure and requiring mechanical ventilation <br/ ><br>8 Subjects with any concurrent medical condition or uncontrolled, clinically significant systemic disease (e.g. heart failure, hypertension, liver disease, diabetes, anemia etc.) that, in the opinion of investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results. <br/ ><br>9 Subjects with known history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus. <br/ ><br>10 Patient who have participated in another investigational study within 3 months prior to enrolment in this study <br/ ><br>11 Investigators, study personnel, sponsorâ??s representatives and their first-degree relatives. <br/ ><br>12 Pregnant and or lactating subjects <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Madhav Rasayan tablet with Standard treatment for COVID - 19: Madhav Rasayan, 1 Tablet (250 mg) thrice a day for first 5 days and then onwards 1 tablet Madhav Rasayan (250 mg) once a day for next 5 days + Standard treatment for COVID - 19 as per hospital protocol<br>Control Intervention1: Standard treatment for COVID â?? 19 as per hospital protocol: Standard treatment for COVID â?? 19 as per hospital protocol<br>→ | Time (Days) to clinical improvement from study enrolmentTimepoint: Baseline, Day of Discharge→ | | | | Yes | False | | |
| → | CTRI/2020/11/029437 | 27 January 2021 | A study to evaluate post COVID-19 lung damage.
| A retrospective study to evaluate clinical and radiological course in COVID 19 interstitial pneumonia.
| | Medanta Institute of Education and Research | 27-11-2020 | 20201127 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49744 | Not Recruiting | No | | | | 15-12-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Bornali Datta→ | | Department of Respiratory and Sleep Medicine, Medanta The Medicity, Sector 38 Gurgaon Haryana 122 001 India → | bornalidatta@googlemail.com→ | 9818462626→ | Medanta The Medicity Gurugram Haryana India→ | Inclusion criteria: 1. Patients confirmed with COVID-19, admitted to Medanta-The Medicity, Gurgaon, India. <br/ ><br>2. Patients with moderate or severe COVID 19 pneumonia, admitted to ward or ICU.→ | Exclusion criteria: 1. Age <18 years <br/ ><br>2. Patients with mild COVID 19 <br/ ><br>3. Pregnant female <br/ ><br>4. Patients with history of COVID-19 Interstitial Pneumonia treatment→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | High-resolution computed tomography (HRCT) features of COVID 19 at presentation and 12 weeks later <br/ ><br>Timepoint: High-resolution computed tomography (HRCT) features of COVID 19 at presentation and 12 weeks later <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/11/029438 | 27 January 2021 | Reinfection with SARS-COV-2 and associated factors | Risk of COVID-19 re-infection and its predictors | | Christian Medical College Vellore | 27-11-2020 | 20201127 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49809 | Not Recruiting | No | | | | 04-01-2021 | 600 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Jacob John→ | | Department of Community Health Christian Medical College→ | jebu@cmcvellore.ac.in→ | 9442631628→ | Christian Medical College Vellore→ | Inclusion criteria: Residents of the study area→ | Exclusion criteria: Acute febrile illness compatible with COVID19 at recruitment→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | PCR confirmed SARS-COV-2 infectionTimepoint: 104 weekly samples for asymptomatic infection and adhoc samples when presenting with clinical illness compatible with COVID-19→ | | | | Yes | False | | |
| → | CTRI/2020/12/029475 | 27 January 2021 | A clinical study to determine the effect of CL20189 and CL20193 in mild to moderate COVID-19 patients | A randomized, double-blind, clinical study to evaluate the effect of CL20189 and CL20193 in mild to moderate COVID-19 subjects | | CLS Pvt Ltd | 01-12-2020 | 20201201 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49723 | Not Recruiting | No | | | | 07-12-2020 | 66 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | N/A | India→ | Mr Ajjarapu Srinivasu→ | | Room No-101,Ground Floor, Sales Department, Aswaraopet → | krishnachaitanya.k@lailanutra.in→ | | CLS Pvt Ltd→ | Inclusion criteria: Male and female subjects (from OPD/ Hospital Isolation /Quarantine ward) aged between 20-60 years with body mass index (BMI) of 22-29.9 kg/m2. Subjects confirmed as positive for Laboratory (RT-PCR) SARS-CoV-2. <br/ ><br>Subjects with symptoms of mild illness with COVID-19 that include any of the following symptoms: fever, sore throat, cough, malaise, headache, muscle pain, gastrointestinal symptoms. <br/ ><br>Subjects with symptoms of moderate illness with COVID-19 that include mild illness or shortness of breath with exertion or any of the following clinical signs; <br/ ><br>Heart rate/Pulse rate: â?¥ 90 beats/min <br/ ><br>Respiratory rate â?¥ 20 breaths/min <br/ ><br>Saturation of oxygen (SpO2) > 93% on room air <br/ ><br>Subjects willing to refrain from special diets, probiotics, taking nutritional supplements or medications known to affect immune function or absorption of nutrients during the study period. <br/ ><br>Female subjects have a negative pregnancy test at the screening visit. <br/ ><br>Ability to understand the risks/benefits of the protocol and willing to sign the informed e-consent. <br/ ><br>→ | Exclusion criteria: Subjects with severe or critical COVID-19 condition as per chest CT scan. <br/ ><br>Subjects allergic to any of the study supplement ingredients. <br/ ><br>Subjects with uncontrolled diabetes (RBS >140mg/dL), hypertension (Systolic >145 and Diastolic >90 mmHg). <br/ ><br>Subjects underwent treatment for COVID-19 will be excluded. <br/ ><br>Subjects using Immune modifying medications for last one month, Steroids- for last 03 months). <br/ ><br>Subjects with any history of immune system disorder or auto-immune disorders. <br/ ><br>Subjects with Pneumonia, COPD, asthma, any respiratory or breathing related disorders. <br/ ><br>Subjects who consume alcohol ( >5 drinks per week), habit of smoking, chewing tobacco, use of recreational drugs (such as cocaine, methamphetamine, marijuana etc.). <br/ ><br>Evidence or history of hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases, malignancies. <br/ ><br>Subjects with HIV Positive. <br/ ><br>Female subjects, who are pregnant, breast feeding or planning to become pregnant during the study. <br/ ><br>Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. <br/ ><br>Any other condition that, in the opinion of the investigator, would adversely affect the subjectâ??s ability to complete the study or its measures. <br/ ><br>Subjects who have participated or currently participating in another clinical trial within 30 days prior to screening. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Arm 1: Subjects will receive the Standard therapy along with the CL20189 (CL20189 500 mg - One capsule daily in the morning orally for 30 days)<br>Intervention2: Arm 2: Subjects will receive the Standard therapy along with the CL20193 (CL20193 500 mg - One capsule daily in the morning orally for 30 days)<br>Control Intervention1: Arm 3: Subjects administered with Standard therapy along with the placebo (Placebo - One capsule daily in the morning orally)<br>Control Intervention2: Arm 3: Subjects will receive the Standard therapy along with the placebo (Placebo - One capsule daily in the morning orally for 30 days)<br>→ | Change in time to clinical recovery including RT-PCRTimepoint: Baseline to End of the study→ | | | | Yes | False | | |
| → | CTRI/2020/12/029476 | 27 January 2021 | A clinical trial to study the effect of herbal medicine on enhancing immune function in COVID recovery patients | Effect of purified standard extract of Withania somnifera, Phyllanthus emblica and Shilajeet in SARS-CoV-2 recovery patients | | NATREON INC | 01-12-2020 | 20201201 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48455 | Not Recruiting | No | | | | 15-12-2020 | 120 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Double Blind Double Dummy | Phase 2 | India→ | Dr Srikanta Pandit→ | | Department of Kayachikitsha
J.B. Roy State Ayurvedic Medical College and Hospital
170-172 Raja Dinendra Street Kolkata West Bengal India
PIN-700004
→ | srikantapandit@gmail.com→ | 9831723650→ | Department of Kayachikitsha J.B. Roy State Ayurvedic Medical College and Hospital→ | Inclusion criteria: Age 18-60 years <br/ ><br>Presently SARS-CoV-2 RT-PCR test negative <br/ ><br>Who have recovered from SARS-CoV-2 <br/ ><br>Mild to moderate SARS-CoV-2 infection in the past <br/ ><br>Having a hospital discharge report of SARS-CoV-2 <br/ ><br>Residence within the catchment area of the hospital <br/ ><br>Provision of signed informed consent <br/ ><br>→ | Exclusion criteria: Age below 18 years and above 60 years <br/ ><br>Signs& symptoms of SARS COV-2 <br/ ><br>Past history of serious cardiac problem <br/ ><br>Past history of severe diabetes <br/ ><br>Past history of serious renal failure <br/ ><br>Past history of serious respiratory diseases <br/ ><br>Past history of serious liver disorders <br/ ><br>Past history of serious mental disorders <br/ ><br>Presently pregnant or lactating women or expecting to become pregnant during the study period <br/ ><br>Unwilling to give written consent <br/ ><br>Use of any medications or supplements which, in the opinion of the investigators, may influence the results of the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Capsule containing standardized extract of Aswagandha, Amla & Shilajeet: 125 mg, single daily for 12 weeks<br>125 mg, twice daily for 12 weeks<br>250 mg, twice daily for 2 weeks<br><br>Control Intervention1: Placebo (Vitamin Capsule): Vitamin capsule twice daily for 12 weeks<br>→ | The role of purified standardized extract of Aswagandha, Amla & Shilajeet on body immune functions of post SARS-CoV-2 recovered patients (not more than 6 months) as measured by means of molecular immune markers like, CRP, IgG, IgM, CD4+, CD8+, IL1b, IL6, IL10, TNFα, Interferon γ suspected to viral infections during COVID-19Timepoint: 18 months→ | | | | Yes | False | | |
| → | CTRI/2020/12/029452 | 27 January 2021 | Covid outcomes among patients with comorbidities | Hospitalization outcomes of SARS-CoV-2 infection among patients with pre-existing chronic medical illness | | Dr Swathy Moorthy | 01-12-2020 | 20201201 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49272 | Not Recruiting | No | | | | 15-12-2020 | 1000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Swathy Moorthy→ | | Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai, Tamilnadu → | drswathymoorthy@sriramachandra.edu.in→ | 9444016401→ | Sri Ramachandra University→ | Inclusion criteria: 1. Age: above 18 years; both genders <br/ ><br>2. All cases were diagnosed with COVID 19 infection based on the clinical manifestations <br/ ><br>3. Confirmed by RT-PCR or CBNAAT: 2019 novel coronavirus in nasal and pharyngeal swab specimens. <br/ ><br>4. Individuals with lung disorders like Bronchial asthma, ILD, COPD, cardiovascular disorders, cerebrovascular accidents, psychiatric disorders, diabetes, hypertension, obesity, endocrine disorders, rheumatoid arthritis, SLE, other connective tissue disorders, vasculitis and hematological disorders, renal disorders, malignancies, immune deficiency disorders or infections like HIV, Tuberculosis etc as co morbid conditions are included <br/ ><br>→ | Exclusion criteria: 1. Patients with Common bacteria or viruses associated with community-acquired pneumonia. <br/ ><br>2. Patients under the age of 18 years with or without COVID-19 infection <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: nil: nil<br>Control Intervention1: nil: nil<br>→ | hospitalisation outcome of covid 19 among patients with comorbiditiesTimepoint: at baseline,4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/12/029478 | 27 January 2021 | study of Covid 19 infection in hemodialysis and post renal transplant patients | Study of clinical course and outcome of covid 19 infection in hemodialysis and renal transplant patients. | | DrMaulin Shah | 01-12-2020 | 20201201 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49796 | Not Recruiting | No | | | | 11-12-2020 | 80 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Investigator Blinded | N/A | India→ | DrMaulin Shah→ | | Privilege centre, The Healing Tree, Shree Krishna Hospital,H M Patel centre for medical care and education,Karamsad, Anand Dialysis centre,privilege economy ward,Shree Krishna hospital,Karamsad,Anand→ | mauls39@gmail.com→ | 9904163277→ | Pramukhswami medical college,H M Patel centre for medical care and education→ | Inclusion criteria: All covid positive (Rapid antigen test or RT PCR) end stage renal disease and renal transplant patients admitted in shree Krishna hospital for further management <br/ ><br>All covid positive end stage renal disease and renal transplant patients who visited flu opd and advised for home quarantine and dialysis in covid ICU on day car basis <br/ ><br>→ | Exclusion criteria: Those Covid positive end stage renal disease patients will be excluded from study whose complete data not available in hospital record→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: N186- End stage renal disease
Health Condition 3: Z940- Kidney transplant status
→ | | This study will give us robust data regarding impact of covid 19 on survival of end stage renal disease and post renal transplant patientsTimepoint: 4 months→ | | | | Yes | False | | |
| → | CTRI/2020/12/029454 | 27 January 2021 | Severity of COVID among type 2 diabetes patients | Study on characteristics and prognosis of diabetes and non diabetes patients with COVID 19 among southern Indian population | | India Diabetes Research Foundation | 01-12-2020 | 20201201 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49574 | Not Recruiting | No | | | | 26-11-2020 | 1050 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ambady Ramachandran→ | | Department of Diabetology
Research Division
Room No: 1
India Diabetes Research Foundation
No:3 & 4, Montieth Road, Egmore → | research@ardiabetes.org→ | | India Diabetes Research Foundation→ | Inclusion criteria: >18 yrs male or female <br/ ><br> <br/ ><br>COVID-19 positive <br/ ><br>→ | Exclusion criteria: COVID 19 Negative <br/ ><br> <br/ ><br>New-onset Diabetes with covid-19 infection <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: E118- Type 2 diabetes mellitus with unspecified complications
→ | | To identify the disease severity and outcome among people with and without diabetes hospitalized for COVID 19 virus infectionTimepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/12/029463 | 27 January 2021 | Types of drugs used and their side effects in Covid-19 patients | Drug Utilization Pattern and Adverse Drug Reaction Monitoring of COVID 19 patients of Lok Nayak Hospital | | Maulana azad medical college | 01-12-2020 | 20201201 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49849 | Not Recruiting | No | | | | 07-12-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Bhupinder Singh Kalra→ | | Dept of Pharmacology
Maulana azad medical college
Delhi → | drbskalra@gmail.com→ | 9968604487→ | Maulana Azad Medical College→ | Inclusion criteria: 1. Patients with confirmed diagnosis of COVID 19 with RT-PCR <br/ ><br>2. Patients willing to give Informed consent <br/ ><br>3. All patients irrespective of gender and age group. <br/ ><br>→ | Exclusion criteria: 1. All suspect cases of COVID 19 infection <br/ ><br>2. Patients not willing to give consent for the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | | Number and types of drugs prescribedTimepoint: At baseline and on discharge→ | | | | Yes | False | | |
| → | CTRI/2020/12/029456 | 27 January 2021 | How COVID 19 affected MAHE students diet and lifestyle practices | Assessment and comparison of diet and lifestyle practices of MAHE students from multi-disciplinary professional courses, pre and during COVID -19.
| | Mr Aswindev J | 01-12-2020 | 20201201 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49340 | Not Recruiting | No | | | | 03-12-2020 | 294 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Asha Moideen→ | | Department of Dietetics and Applied Nutrition, Welcomgroup Graduate School of Hotel Administration, Madhav nagar, Manipal Manipal Academy of Higher Education, Manipal
→ | meenakshi.garg@manipal.edu→ | 9343163237→ | Welcomgroup Graduate School of Hotel Administration,Manipal→ | Inclusion criteria: Students under the MAHE constitution pursuing medicine, dental, pharmacology, allied health sciences, architecture, and management, willing to participate in the study.→ | Exclusion criteria: Male and female students who are on long term medications <br/ ><br> <br/ ><br>Immunocompromised Students <br/ ><br>→ | | | To compare the dietary and lifestyle practices of students before and during COVID-19Timepoint: December, 2020→ | | | | Yes | False | | |
| → | CTRI/2020/12/029515 | 27 January 2021 | Impact of COVID-19 pandemic on post graduate medical trainees in India | To study impact of COVID-19 pandemic on post graduate medical trainees in India | | Dr Jyoti Khanna Principal Investigator | 02-12-2020 | 20201202 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49857 | Not Recruiting | No | | | | 06-12-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Jyoti Khanna→ | | Department of Pharmacology,Pandit B.D.Sharma, PGIMS, Rohtak Department of Pharmacology,Pandit B.D.Sharma, PGIMS, Rohtak→ | jk.jyotikhanna1@gmail.com→ | 09813161766→ | Assistant Professor, Department of Pharmacology, Pandit B.D.Sharma, PGIMS, Rohtak→ | Inclusion criteria: a)Consent/Voluntary participation by the postgraduate trainees enrolled at various MCI accredited medical institutions in India. <br/ ><br>b) Individuals of all gender identities and any age group.→ | Exclusion criteria: None→ | | | Demographics <br/ ><br>Traineeâ??s emotional and mental wellbeing during COVID Pandemic <br/ ><br>PPE and risk for exposure <br/ ><br>Clinical training and residency educationTimepoint: 1 month→ | | | | Yes | False | | |
| → | CTRI/2020/12/029564 | 27 January 2021 | : Serial sero-epidemiological surveillance study to monitor the trend of SARS-CoV-2, Dengue and Chikungunya infection transmission in the Vellore Demographic Health Surveillance System (HDSS) | A Cohort Study to study SARS-CoV-2(Severe Acute Respiratory Syndrome Corona Virus), Dengue, Chikungunya in India | | Dr Winsley Rose | 04-12-2020 | 20201204 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48916 | Not Recruiting | No | | | | 10-12-2020 | 5000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Winsley Rose→ | | Department of Pediatrics (Unit-3),
Christian Medical College,
Vellore-632004 → | winsleyrose@gmail.com→ | 04162283343→ | Christian Medical College, Vellore→ | Inclusion criteria: all individuals currently residing and likely to stay in the area till the end of study (1 year) in the study area will be considered eligible for inclusion.→ | Exclusion criteria: none→ | | | I. Estimate the sero-prevalence of SARS-CoV-2 infection in the general population <br/ ><br>II. Estimate the 4 monthly incidence of SARS-CoV-2 infection based on serial sero-surveys <br/ ><br>III. Estimate cumulative sero-conversion of SARS-CoV-2 infection over one year period <br/ ><br>IV. Estimate the sero-prevalence and annual sero conversion of Dengue and Chikungunya in a sub sample of the study <br/ ><br>Timepoint: serosurvey will be done once in 3 months for a period of one year→ | | | | Yes | False | | |
| → | CTRI/2020/12/029575 | 27 January 2021 | Effectiveness of Unani add-on therapy in preventing the disease severity of COVID-19 infection | A study to assess the safety and efficacy of add-on Unani regimen in preventing the progression of severity of the disease in mild to moderate symptomatic COVID-19 RT-PCR positive cases | | Central Council for Research in Unani Medicine | 04-12-2020 | 20201204 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49430 | Not Recruiting | No | | | | 04-12-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 3 | India→ | Dr Tamanna Nazli→ | | Unani Medical Center
Vardhman Mahavir Medical College & Safdarjung Hospital
New Delhi → | dr.rohitkumar@mail.com→ | 9911218081→ | Vardhman Mahavir Medical College & Safdarjung Hospital→ | Inclusion criteria: 1. On the day of admission patients who have been tested positive with SARS-CoV2 virus through RT PCR <br/ ><br>2. Patients with mild symptoms <br/ ><br> or <br/ ><br>Patients with moderate symptoms with respiratory rate < 30 per minute and oxygen saturation > 90% <br/ ><br>→ | Exclusion criteria: 1. COVID-19 patients with symptoms classified as severe or critical. <br/ ><br>2. Suspected COVID-19, not tested positive for COVID-19 by RT-PCR <br/ ><br>3. Persons with severe primary respiratory disease or pneumonia <br/ ><br>4. Pregnant and lactating women <br/ ><br>5. Persons with severe illness such as Cancer, Heart Disease, Stroke, Mental disorder, etc., and who are considered to be excluded from the study as evaluated by the Investigators <br/ ><br>6. COVID-19 positive cases simultaneously participating as subjects in the interventional arm of other COVID-19 clinical trials <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J09- Influenza due to certain identified influenza viruses
→ | Intervention1: Unani Decoction/ Joshanda<br>add-on with Conventional Allopathic treatment: Unani Decoction twice daily orally <br>Ingredients of Unani Decoction:<br>1. Behidana (Cydonia oblonga) 3 g,<br>2. Unnab (Zizyphus jujube) 5 in number,<br>3. Sapistan (Cordia myxa) 9 in numbers,<br>Decoction prepared by boiling all ingredients in 250 ml of water and Used lukewarm once daily.<br><br>Intervention2: Tiryaq-e-Arba along with the Conventional Allopathic treatment: 5g twice daily Orally for 14 days <br>Ingredients of Tiryaq-e-Arba:<br>1. Juntiyana (Gentiana lutea L.) <br>2. Zarawand Taweel (Aristolochia longa L.)<br>3. Mur Makki (Commiphora myrrha (Nees) Engl.)<br>4. Habb-ul-Ghar (Laurus nobilis L.)<br>5. Honey or Sugar<br><br><br>Control Intervention1: Conventional Allopathic treatment: Tab HCQ<br>Tab Azithromycin <br>Tab Vitamic-C<br>Tab Zinc<br><br>Control Intervention2: Conventional Allopathic treatment: Tab HCQ<br>Tab Azithromycin <br>Tab Vitamic-C<br>Tab Zinc<br>→ | - Duration of subsidence of fever, respiratory and other COVID-19 symptomsTimepoint: Day 0 to Day 14→ | | | | Yes | False | | |
| → | CTRI/2020/12/029581 | 27 January 2021 | A study of kidney Problems with covid 19 in admitted patients at a teritiary care hospital. | A study of renal manifestations and its outcome in hospitalised patients with Covid 19 at a tertiary care hospital in Dakshina Kannada ,Karnatak - ROCD | | nil | 04-12-2020 | 20201204 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49709 | Not Recruiting | No | | | | 21-12-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Santhosh pai→ | | Department of Nephrology
Yenepoya Medical College,
Mangalore.
Maurshka palace apartment, Kadri, Mangalore.→ | drbhspai22@yahoo.co.in→ | 9449471243→ | Yenepoya Medical College→ | Inclusion criteria: All patients diagnosed with covid 19 including children either by RT-PCR or rapid antigen test admitted in our hospital.→ | Exclusion criteria: Case files where urinary analysis and kidney function evaluation reports are not present.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: B338- Other specified viral diseases
→ | | . Newly developed cases of renal impairment and their outcome with respect to mortality, severity of the diseaseTimepoint: . till the time of discharge (1 hour to 4weeks.→ | | | | Yes | False | | |
| +++ | CTRI/2020/12/029582 | 27 January 2021 | Baricitinib in Patients with COVID-19 Infection | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Study of Baricitinib in Patients with COVID-19 Infection | | Eli Lilly and Company India Pvt Ltd | 04-12-2020 | 20201204 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48958 | Recruiting | No | | | | 18-12-2020 | 1000 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Double Blind Double Dummy | Phase 3 | | | | | | | | | | | | | | | | Yes | False | | |
| → | CTRI/2020/12/029586 | 27 January 2021 | Various Blood Parameters Affecting outcome in ICU Patients
| Assessment of predictors of severity in
COVID 19 patients admitted to intensive care unit of a tertiary care hospital
| | jss medical college | 04-12-2020 | 20201204 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49982 | Not Recruiting | No | | | | 15-12-2020 | 150 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | DR Rajalakshmi R→ | | DEPARTMENT OF PHYSIOLOGY
JSSMC
MYSORE shivarathreshwaranagar
bannimantap mysore→ | rajalakshmir@jssuni.edu.in→ | 8971415623→ | jss medicical college→ | Inclusion criteria: Patients with COVID 19 infection admitted in ICU→ | Exclusion criteria: Patients not willing to give consent for the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To assess the predictors of severity in COVID 19 patients admitted in Intensive care unit by analyzing the haematological and biochemical parameters.Timepoint: on admission and every second day→ | | | | Yes | False | | |
| → | CTRI/2020/12/029563 | 27 January 2021 | â??AN OBSERVATIONAL STUDY OF HIGH FLOW NASAL OXYGEN THERAPY IN COVID 19 PATIENTS ADMITTED IN INTENSIVE CARE UNITâ?? | An observational study of High Flow Nasal Oxygen Therapy in COVID-19 patients admitted in intensive care unit | | Not applicable | 04-12-2020 | 20201204 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49001 | Not Recruiting | No | | | | 10-12-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ashwin sonkamble→ | | Associate professor, department of Anaesthesiology, ggmc, JJ hospital campus.byculla Associate professor, Department of Anaesthesiology,
6th floor, main building, GGMC, JJ hospital campus, byculla 08→ | seeashwin@rediffmail.com→ | | Grant government medical college→ | Inclusion criteria: 1.Patients between age 18-60years <br/ ><br>2.Both males and females <br/ ><br>3.Patients with type 1 respiratory failure <br/ ><br>4.Patients with SpO2 less than or equal to 92% on room air <br/ ><br>5.Patients with or without co morbidities→ | Exclusion criteria: 1.Patientâ??s refusal for HFNO <br/ ><br>2.Patients below 18years and above 60years <br/ ><br>3. Patients with tracheostomy <br/ ><br>4. Patients with Claustrophobia <br/ ><br>5.Patients with urgent need for endotracheal intubation <br/ ><br>6.Patients with GCS less than 8 or raised intracranial tension <br/ ><br>7.Patients with upper airway obstruction <br/ ><br>8. Pregnant patients→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Whether high flow nasal oxygen therapy can treat hypoxia in COVID 19 patientsTimepoint: During ICU stay→ | | | | Yes | False | | |
| → | CTRI/2020/12/029584 | 27 January 2021 | Effects of PPE among Healthcare Workers | A study of physical and emotional effects of PPE among healthcare workers handling COVID 19 patients | | Dr Swathy Moorthy | 04-12-2020 | 20201204 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49269 | Not Recruiting | No | | | | 15-12-2020 | 150 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Swathy Moorthy→ | | Department of General Medicine, Sri Ramachandra Medical College, SRIHER, Porur, Chennai, Tamilnadu → | drswathymoorthy@sriramachandra.edu.in→ | 9444016401→ | Sri Ramachandra University→ | Inclusion criteria: doctors and nurses who handle COVID 19 patients and wear PPE for more than 2 hours duration→ | Exclusion criteria: healthcare workers who don the PPE for less than 2 hours duration→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: nil: nil<br>Control Intervention1: nil: nil<br>→ | knowledge of the physical and emotional effects of PPE among the healthcare workersTimepoint: at baseline→ | | | | Yes | False | | |
| → | CTRI/2020/12/029587 | 27 January 2021 | To compare the effect of lying in face down position along with oxygen therapy given through high flow nasal cannula device versus lying face down with oxygen given by non-rebreathing face mask in COVID-19 patients. | Efficacy of awake prone positioning with high flow nasal cannula versus prone positioning with non-rebreathing mask in COVID-19 patients. A prospective comparative study.
| | All India Institute Of Medical Sciences Patna | 04-12-2020 | 20201204 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49803 | Not Recruiting | No | | | | 15-12-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Rajnish Kumar→ | | Department of Anaesthesiology,
All India Institute of Medical Sciences Patna, Phulwari sharif, Patna → | drraj76pmch@gmail.com→ | 7783865337→ | All India Institute Of Medical Sciences Patna→ | Inclusion criteria: 1. Adult Confirmed COIVD19 positive patients admitted to ICU for acute hypoxemic respiratory failure. <br/ ><br>2. Acute hypoxemic respiratory failure defined by respiratory rate â?¥25 breaths/min, and PaO2/FiO2 â?¤300 mm Hg while spontaneously breathing under standard oxygen therapy. <br/ ><br>→ | Exclusion criteria: 1. BMI more than 40 <br/ ><br>2. Immediate need of intubation <br/ ><br>3. Sign of respiratory failure (RR > 40/min, PaCO2 > 50 mmHg/pH < 7.30, and obvious accessory respiratory muscle use) <br/ ><br>4. Unstable hemodynamic status <br/ ><br>5. Impending cardiopulmonary arrest, <br/ ><br>6. Glasgow coma scale score lower than 8. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Awake prone position with high flow nasal cannula: Oxygen will be given through high flow nasal oxygen at flows of 60 L/min and FiO2 adjusted to obtain oxygenation (SpO2 â?¥92%). Patients will be encouraged for awake proning as per sequence. A minimum of 8 hours of prone positioning per day shall be encouraged.<br>Control Intervention1: Awake prone positioning with non-rebreathing mask: Patient will receive high flow oxygen@10 to 15 litre/min with non rebreathing mask to maintain adequate oxygenation ((SpO2 â?¥92%). All patients shall be encouraged prone positioning in this group also<br>→ | To compare the rates of intubation between the two groupsTimepoint: 28 days→ | | | | Yes | False | | |
| → | CTRI/2020/12/029585 | 27 January 2021 | A clinical trial to compare the effect of non-invasive ventilation with high-flow nasal oxygen therapy versus only high flow nasal oxygen therapy in COVID 19 patients with respiratory failure. | Effect of non-invasive ventilation with high-flow nasal oxygen therapy in COVID 19 patients. - NIVHOC | | All India Institute Of Medical Sciences Patna | 04-12-2020 | 20201204 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49854 | Not Recruiting | No | | | | 12-12-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Kunal Singh→ | | Department of Anaesthesiology,
All India Institute Of Medical Sciences Patna, Phulwari Sharif, Patna → | drkunals@aiimspatna.org→ | 9411514945→ | All India Institute Of Medical Sciences Patna→ | Inclusion criteria: 1 Adult (Age >18years) <br/ ><br>2 Confirmed COVID 19 patients tested positive for SARS-CoV-2 via nasopharyngeal swab by RT-PCR test and admitted to intensive care unit. <br/ ><br>3 Acute hypoxemic respiratory failure defined by respiratory rate â?¥25 breaths/min, and PaO2/FiO2 â?¤300 mm Hg while spontaneously breathing under standard oxygen therapy. <br/ ><br>→ | Exclusion criteria: Patients will be excluded if PaCO2 above 50 mm Hg, underlying chronic lung disease, cardiogenic pulmonary edema, severe shock, impending cardiopulmonary arrest, Glasgow coma scale score lower than 8 & absence of airway protective gag reflex.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Noninvasive ventilation with high flow nasal oxygen therapy: Patient will received noninvasive ventilation through face mask via an ICU ventilator. Pressure support mode to be used to target tidal volume of 6-8ml/kg predicted bodyweight. HFNO will be used intermittently when NIV is removed.<br>Control Intervention1: High flow nasal oxygen therapy: Oxygen will be delivered through large bore nasal cannula at high flow with humidified gases. Oxygen flow rate & inspired fraction of oxygen (FiO2) will be titrated according to patient requirement.<br>→ | To compare the rates of endotracheal intubation between the two strategies.Timepoint: 28 days→ | | | | Yes | False | | |
| → | CTRI/2020/12/029614 | 27 January 2021 | Liberal use of oxygen in early stage of COVID-19 patients. | Early Liberal Oxygen Therapy in COVID-19: An open-labeled randomized control trial - OXYCOVID | | All India Institute of Medical Sciences Jodhpur | 07-12-2020 | 20201207 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49680 | Not Recruiting | No | | | | 16-12-2020 | 80 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Mahendra Kumar Garg→ | | Department of Medicine,
AIIMS Jodhpur,
Basni Second Phase
Jodhpur
→ | mkgargs@gmail.com→ | 9089081353→ | ALL INDIA INSTITUTE OF MEDICAL SCIENCES JODHPUR→ | Inclusion criteria: Part I: Patients >18 years of age diagnosed as COVID-19 positive by reverse transcriptase Polymerase Chain Reaction (RT PCR) and are having mild COVID-19 with cough or dyspnea or both with room air saturation is within normal limits ( > 94%). <br/ ><br>Part II: Patients >18 years of age diagnosed as COVID-19 positive by reverse transcriptase Polymerase Chain Reaction (RT PCR) and PaO2/FiO2 of 200-350 as assessed by arterial blood gas (ABG) analysis. <br/ ><br>→ | Exclusion criteria: 1.Any patient requiring immediate intubation and ventilatory care <br/ ><br>2.Hemodynamic instability BP < 90/60 mm Hg or on inotropic support <br/ ><br>3.Elevated intracranial pressure <br/ ><br>4.Altered sensorium or history of seizures <br/ ><br>5.Any psychiatric comorbidity <br/ ><br>6.Pregnancy <br/ ><br>7.Patients at high risk of requiring CPR or defibrillation (known arrhythmias) <br/ ><br>8.Known chronic cardiopulmonary diseases like Bronchial asthma (with history of wheeze or bronchodilator use), chronic obstructive pulmonary disease, interstitial lung disease (aassessed by Computed Tomography (CT) Chest), congestive heart failure (clinical assessment), and obstructive sleep apnea (assessed with Epworth Sleepiness scale). <br/ ><br>9.Any recent acute condition like pulmonary embolism, acute coronary syndrome, deep vein thrombosis, intestinal obstruction or cerebrovascular accident. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Early liberal oxygen therapy - PART I: Part I: Patients will be randomized to liberal oxygen supplementation where patient will be supplemented with oxygen with nasal prongs at a rate of 0.5L/min and assessed continually for vital signs and every 4 hours for symptoms. If not symptomatically improved, oxygen will be increased at a rate of 0.5L/min per 4 hours to a maximum of 2L/min. Patient will be monitored continuously for next 5 days and watched for clinical deterioration or symptomatic relief which will be marked as an event. If during study period, any patient has increasing symptoms with desaturation (94%) or develops new symptoms discomfort due to oxygen flow or tinnitus, blurring of vision, study will be stopped for that particular patient and marked as an event and will be offered usual care as per the discretion of the treating physician.<br>Intervention2: Early liberal target -PART II: Part II: Patients will be randomized to liberal oxygen supplementation with a PaO2 target of 90-105 mmHg (approximately oxygen saturation of â?¥96%) versus usual target of 60-75 mmHg (approximately oxygen saturation of 90-94%) after enrollment and informed consent. Randomization will be done using random number generation using standard software. The resident doctor on duty will call the designated person (one of the PIs) for allocation over phone. Allocation will be concealed from the nursing staff/resident doctor and the patient prior to that time. This will be an open-labeled study. Baseline parameters related to demographic data, clinical features, laboratory investigations and previous comorbidities/treatment will be collected. <br>Intervention: Patients in liberal oxygen supplementation group will be supplemented with nasal oxygen using prongs/cannula or face-mask→ | Primary outcome â?? I: Time to becoming symptom free (cough, breathlessness. <br/ ><br>Primary outcome â?? II: Change in PaO2/FiO2 ratio in both groups will be compared. <br/ ><br>Timepoint: Primary outcome â?? I: Time to becoming symptom free (cough, breathlessness, assessed at 6th day. <br/ ><br>Primary outcome â?? II: Change in PaO2/FiO2 ratio in both groups will be compared at end of 6th day. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/12/029615 | 27 January 2021 | Remdesivir plus Tocilizumab efficacy trial in moderate to severe COVID-19 patients | Efficacy of Remdesivir versus Remdesivir plus Tocilizumab in moderate to severe COVID-19 patients, admitted in the CCU of a tertiary care hospital in West Bengal | | Dr Swati Datta | 07-12-2020 | 20201207 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49731 | Not Recruiting | No | | | | 15-12-2020 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Dr Swati Datta→ | | Tutor Room No. 1
Department of Anaesthesiology
Green Building, 2nd floor
Medical College, Kolkata
88, College St, College Square,
Kolkata-700073 88, College St, College Square,
Kolkata-700073→ | drslahiri11@gmail.com→ | 9836979351→ | Medical College, Kolkata→ | Inclusion criteria: Patients with moderate to severe COVID-19 disease with following criteria : <br/ ><br>1. Age >18 years <br/ ><br>2. Laboratory confirmed COVID-19 patients <br/ ><br>3. SpO2 94% <br/ ><br>4. Patients on different modalities of oxygen therapy <br/ ><br>5. Patients with radiologically confirmed pneumonia <br/ ><br>6. ARDS / Acute Respiratory Failure <br/ ><br>Presence of raised inflammatory markers e.g. CRP, ferritin, IL-6 <br/ ><br>→ | Exclusion criteria: Patients with moderate to severe COVID-19 disease with following criteria : <br/ ><br>1. Pregnancy or breast feeding <br/ ><br>2. Serum alanine aminotransferase(ALT) or aspartate aminotransferase (AST) >5 times the upper limit of normal (ULN) <br/ ><br>3. Known severe renal impairment (eGFR ï?¼30 ml/min/1.73 m2 or on continuous RRT (hemodialysis, peritoneal dialysis) <br/ ><br>4. Known severe allergic reactions to tocilizumab or other monoclonal antibodies <br/ ><br>5. Known hypersensitivity to remdesivir <br/ ><br>6. Treatment with immunosuppressive or immunomodulatory therapy (including tocilizumab) within the past 3 months <br/ ><br>7. Absolute neutrophil count (ANC) < 1000/uL at screening <br/ ><br>8. Clinical evidence of active tuberculosis or blood culture proven active secondary infections <br/ ><br>9. Participating in other drug clinical trials <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Remdesivir plus Tocilizumab group: Remdesivir, 200 mg IV on day-1 f/b 100 mg IV on day-2-5. PLUS<br> Tocilizumab 400 mg slow IV, may be repeated after 12 hours.<br>Control Intervention1: Remdesivir group: Remdesivir, 200 mg IV on day-1 f/b 100 mg IV on day-2-5<br>→ | Proportion of moderate to severe COVID-19 patients achieving clinical improvement defined as a 2 point reduction in patientsâ?? admission status six-point ordinal scale or live discharge from the hospital, which ever come first.Timepoint: 28 days from the point of randomization.→ | | | | Yes | False | | |
| → | CTRI/2020/12/029613 | 27 January 2021 | Drug to prevent lung injury secondary to COVID 19 | Nebulised Heparin to Reduce COVID-19 Induced Acute Lung Injury | | Department of anaesthesiology AIIMS Rishikesh | 07-12-2020 | 20201207 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50026 | Not Recruiting | No | | | | 14-12-2020 | 30 | Interventional | Non-randomized, Placebo Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Bhavna Gupta→ | | Level 6, Academic block,
department of anaesthesiology, All India Institute of Medical sciences, hospital, Vir bhadra marg, Rishikesh, Uttarakhand → | bhavna.kakkar@gmail.com→ | 8527686660→ | AIIMS hospital, Rishikesh→ | Inclusion criteria: Age 18 years or older, with Endotracheal tube or Noninvasive ventilation in place, intubated/put on NIV yesterday or today with PaO2 to FIO2 ratio less than or equal to 300 <br/ ><br>→ | Exclusion criteria: 1. Heparin allergy or heparin-induced thrombocytopaenia <br/ ><br>2. APTT > 120 seconds and this is not due to anticoagulant therapy <br/ ><br>3. Platelet count < 20 x 109 per L <br/ ><br>4.Pulmonary bleeding, which is frank bleeding in the trachea, bronchi or lungs with repeated haemoptysis or requiring repeated suctioning <br/ ><br>5. Uncontrolled bleeding <br/ ><br>6. Pregnant or suspected pregnancy (Urine or serum HCG will be recorded) <br/ ><br>7. Receiving or about to commence ECMO or HFOV <br/ ><br>8. Death is imminent or inevitable within 24 hours <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: nil: Heparin 5000U/ml intravenous formulation will be diluted with 3 ml of 0.9% normal saline, and all critical patients meeting inclusion and exclusion criteria will be nebulised every 8 hours for a period of 7 days.<br>→ | Primary Outcome Measures: <br/ ><br>1. D-dimer profile [ Time Frame: Up to day 10 days. ] <br/ ><br>2. NLR ratio [Time frame up to 10 days] <br/ ><br>3. Mean daily PaO2 to FiO2 ratio [ Time Frame: 10 days ] <br/ ><br>Timepoint: Primary Outcome Measures: <br/ ><br>1. D-dimer profile [ Time Frame: Up to day 10 days. ] <br/ ><br>2. NLR ratio [Time frame up to 10 days] <br/ ><br>3. Mean daily PaO2 to FiO2 ratio [ Time Frame: 10 days ] <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/12/029671 | 27 January 2021 | Blood changes in COVID 19 and itâ??s influence | HEMATOLOGIC AND URINARY PROFILE IN SARS COV 2 COVID 19 | | Dr JAYALAKSHMI B | 09-12-2020 | 20201209 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48689 | Not Recruiting | No | | | | 15-12-2020 | 800 | Observational | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr JAYALAKSHMI B→ | | Department of pathology,
Sri Ramachandra medical College and Research Institute.
Sri Ramachandra Medical Centre
No.1 Ramachandra Nagar, Porur
Chennai, Tamil Nadu,
India 600 116 → | febemd@gmail.com→ | 9994081470→ | SRI RAMACHANDRA MEDICAL COLLEGE AND RESEARCH CENTRE→ | Inclusion criteria: All patients tested for SARS COV 2 COVID 19→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Laboratory parameters associated with mortality and morbidityTimepoint: 9 months→ | | | | Yes | False | | |
| → | CTRI/2020/12/029668 | 27 January 2021 | Add-on homoeopathic treatment of COVID-19 patients | Randomised Controlled Trial to compare efficacy of standard of care alone and in combination
with homoeopathic treatment of COVID-19 Placebo
- HOM_COVID19 | | Central Council for Research in Homoeopathy | 09-12-2020 | 20201209 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45821 | Not Recruiting | No | | | | 01-01-2021 | 128 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Participant Blinded | Phase 2 | India→ | Dr Naval Kumar Verma→ | | President Office, Rejoice Health Foundation, Ground Floor, J-13/34, near Indian Bank, Rajouri Garden, New Delhi-110027, India → | anil23101961@gmail.com→ | | Central Council for Research in Homoeopathy (CCRH)→ | Inclusion criteria: â?¢Age > 18 years <br/ ><br>â?¢All sexes <br/ ><br>â?¢Case definitions for inclusion in the study will include moderate and severe cases as defined in the Guidance on appropriate treatment of suspect/confirmed case of COVID19 issued by Ministry of Health and Family Welfare, Govt of India on 13 June 2020 . <br/ ><br>o Moderate: Pneumonia with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, Respiratory Rate more or equal to 24 per minute. <br/ ><br>o Severe: <br/ ><br>ï?§ Adolescent or adult with clinical signs of Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air. <br/ ><br>ï?§ Acute Respiratory Distress Syndrome Onset: <br/ ><br>ï?§ New or worsening respiratory symptoms within one week of known clinical insult. <br/ ><br>ï?§ Chest imaging (Chest X ray and portable bed side lung ultrasound): bilateral opacities, not fully explained by effusions, lobar or lung collapse, or nodules. Origin of Pulmonary infiltrates: respiratory failure not fully explained by cardiac failure or fluid overload. Need objective assessment (e.g. echocardiography) to exclude hydrostatic cause of infiltrates/ oedema if no risk factor present. <br/ ><br>ï?§ Oxygenation impairment in adults: <br/ ><br>â?¢ Mild ARDS: 200 mmHg < PaO2/FiO2 â?¤ 300 mmHg (with PEEP or CPAP â?¥5 cm H2O) <br/ ><br>â?¢ Moderate ARDS: 100 mmHg < PaO2/FiO2 â?¤200 mmHg with PEEP â?¥5 cm H2O) <br/ ><br>â?¢ Laboratory confirmed SARS CoV-2 infection within last 10 days or SARS <br/ ><br>â?¢ CoV-2 test result pending with a high clinical suspicion as defined by: <br/ ><br>o Cough of <10d duration <br/ ><br>o Bilateral pulmonary infiltrates on chest X Ray / CT scan or new hypoxaemia defined as SpO2 <94% on room air <br/ ><br>o No alternative explanation for respiratory symptoms <br/ ><br>â?¢ Scheduled for admission or enrolled within 48h of hospital admission <br/ ><br>→ | Exclusion criteria: â?¢Pregnant and lactating women, infants and neonates <br/ ><br>â?¢Not willing to give consent for adjuvant treatment <br/ ><br>â?¢In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ ><br>â?¢Symptoms of acute respiratory tract infection for > 10d before randomisation <br/ ><br>â?¢Death within 24 Hrs. of admission→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Homoeopathic medicines: Routinely used homoeopathic medicines for various kinds of flu will be repurposed for COVID 19 treatment. Dose: Orally, 3 times a day, or more frequently, depending on severity; Dispensing form: 4-5 pills at a time, or 1-2 drops in 1 tbsp. of drinking water. Duration: 28 days, or discharge from hospital, whichever is earlier<br>Control Intervention1: Standard of care: Routinely followed standard of COVID care as per IMP.<br>→ | Time taken to get COVID-19 RT-PCR test negative and in improvement of other assessmment parametersTimepoint: Every 5 days for RTPCR, and daily for Oxygen requirement.→ | | | | Yes | False | | |
| → | CTRI/2020/12/029669 | 27 January 2021 | Assessment of pulmonary function test in patients recovered from COVID 19 infection | Assessment of pulmonary function test in patients recovered from COVID 19 infection | | Dr Richa Udhwani | 09-12-2020 | 20201209 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50175 | Not Recruiting | No | | | | 21-12-2020 | 50 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Anand Patel→ | | GMERS Medical College and Hospital
Department of Pulmonary Medicine
206,TB and Chest OPD
Old TB Hospital campus,
Gotri Road,
Gotri, Vadodara → | dranandkpatel@gmail.com→ | 9879771079→ | GMERS Medical College and Hospital Gotri Vadodara→ | Inclusion criteria: Age more than 18 years <br/ ><br>Previously confirmed COVID positive by rapid antigen or RTPCR swab test <br/ ><br>Completed one month after positive test <br/ ><br>Willing to participate and give consent→ | Exclusion criteria: Unstable patients <br/ ><br>Non-compliant patients <br/ ><br>Patients in moribund condition <br/ ><br>Patients with active viral infection <br/ ><br>Patients having old pulmonary tuberculosis, Asthma, COPD, ILD and other chronic <br/ ><br>respiratory diseases <br/ ><br>Patients having chronic diseases like HIV, malignancy etc→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Pulmonary Function Test: Spirometry<br>DLCO<br>MIP<br>MEP<br>MVV<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | To assess pattern of pulmonary functions in patients infected with Covid-19 <br/ ><br>To assess respiratory muscle strength in patients after Covid-19 infection based on MIP, MEP and MVV.Timepoint: 1 month after covid negative report date→ | | | | Yes | False | | |
| → | CTRI/2020/12/029712 | 27 January 2021 | Impact of sugars on patients diagnosed with COVID | Impact of glycemic variability on the outcome of patients diagnosed with SARS-COV 2 virus | | Shravanthi Naidu S Woodayagiri | 10-12-2020 | 20201210 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49971 | Not Recruiting | No | | | | 01-01-2021 | 1000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shravanthi Naidu S Woodayagiri→ | | Department of General Medicine
No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu- 600116 → | swathy.murali@gmail.com→ | 9444016401→ | Sri Ramachandra Institute of Higher Education and Research→ | Inclusion criteria: Patients >18 years who have been diagnosed with SARS COV-2 infection by RTPCR analysis of the nasal swab specimen taken <br/ ><br> <br/ ><br>Type2 diabetes and are on treatment <br/ ><br> <br/ ><br>Patients with impaired glucose tolerance <br/ ><br>FBS >100mg/dl but <126mg/dl <br/ ><br>PPBS >140mg/dl but <200mg/dl <br/ ><br> <br/ ><br>Stress induced hyperglycemia <br/ ><br> <br/ ><br>Patients with no history of impaired glucose tolerance but have â?? <br/ ><br> <br/ ><br>Newly diagnosed diabetic patients (as per WHO guidelines) <br/ ><br> <br/ ><br>→ | Exclusion criteria: Patients <18 years of age with SARS COV-2 infection <br/ ><br> <br/ ><br>GDM <br/ ><br> <br/ ><br>Patients with chronic illness such as <br/ ><br> <br/ ><br>Malignancies <br/ ><br> <br/ ><br>Autoimmune disease <br/ ><br> <br/ ><br>Chronic disease requiring steroids <br/ ><br> <br/ ><br>Smokers <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Not applicable: Not applicable<br>Control Intervention1: NIL: NIL<br>→ | Clinical recovery of the patientTimepoint: At baseline at 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/12/029724 | 27 January 2021 | Has COVID 19 pandemic been affecting scientific trials to be done by students of anaesthesia department? | Impact of COVID 19 pandemic on thesis by anaesthesia trainees in a tertiary care institute of north India | | Post Graduate Institute of Medical Education and Research | 10-12-2020 | 20201210 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50076 | Not Recruiting | No | | | | 20-12-2020 | 91 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Gandhi Komal Anil→ | | Department of Anaesthesia and Intensive Care, 4th Floor, Main OT complex, Nehru Hospital, Post- Graduate Institute of Medical Education and Research, Chandigarh → | dr.komalgandhi@yahoo.com→ | 7087003376→ | Post- Graduate Institute of Medical Education and Research→ | Inclusion criteria: Anaesthesia trainees (M.D. Anaesthesia course as well as D.M super-specialty courses of Anaesthesia) from Department of Anaesthesia and Intensive Care at PGIMER, Chandigarh→ | Exclusion criteria: not applicable→ | | | To assess number of thesis/dissertations by anaesthesia trainees affected by ongoing COVID 19 pandemic.Timepoint: Single time point, cross-sectional study→ | | | | Yes | False | | |
| → | CTRI/2020/12/029713 | 27 January 2021 | A STUDY TO ASSESS THE EFFECTIVENESS OF IMMUNRICH IN COVID 19 POSITIVE PATIENTS | A CLINICAL STUDY TO ASSESS THE EFFICACY OF CAP IMMURICH IN COVID19 POSITIVE PATIENTS - COVID19 IMMURICH | | RPS BIOTECH PVTLTD | 10-12-2020 | 20201210 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46813 | Recruiting | No | | | | 15-12-2020 | 100 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | DR MANOJ RUNGHE→ | | KASHIBA AYURVED HOSPITAL K J
INSTITUTE OF AYURVED AND RESEARCH SAVLI
OPPOSITE ITI SAVLI
JAVLA VADODARA K J INSTITUTE OF AYURVED AND RESEARCH SAVLI
OPPOSITE ITI SAVLI
JAVLA VADODARA→ | principal.kjiar@kjit.org→ | 9687748944→ | K J INSTITUTE OF AYURVED AND RESEARCH AFFILATED TO KASHIBA AYURVED HOSPITAL SAVLI SAVLI VADODARA→ | Inclusion criteria: 2. RT-PCR Based Corona positive patient and <br/ ><br> rapid antigen test <br/ ><br>3. Consent to participate in the trial <br/ ><br>→ | Exclusion criteria: 1. Individual with uncontrolled unstable comorbidities <br/ ><br>2. Individual with pre- existing respiratory conditions <br/ ><br>3. Immunocompromised individuals or those on immunosuppressants <br/ ><br>4. Patients on or requiring parenteral nutrition <br/ ><br>5. Pregnant and lactating female <br/ ><br>→ | Health Condition 1: J988- Other specified respiratory disorders
→ | Intervention1: CAP IMMURICH <br>: 2 BID <br>BEFORE MEAL WITH LUKEWARM WATER<br>DURATION 28 DAYS<br>Control Intervention1: NOT APPICABLE: NOT APPICABLE<br>→ | 1. Improvement in Bala of an individual <br/ ><br>2. Immuno- stimulation leading to non-development of Covid-19 in risk population exposed to infected individual <br/ ><br>Timepoint: <br/ ><br>assessment after 1 week <br/ ><br>1. Improvement in Bala of an individual <br/ ><br>2. Immuno- stimulation leading to non-development of Covid-19 in risk population exposed to infected individual <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/12/029714 | 27 January 2021 | A STUDY TO ASSESS THE EFFECTIVENESS OF CAP ASMO IN COVID 19 POSITIVE CASES | A CLINICAL STUDY TO ASSESS THE EFFICACY OF CAP ASMO IN COVID 19 POSITIVE CASES AN OPEN LABELLED SINGLE ARM STUDY | | RPS BIOTECH PVT LTD | 10-12-2020 | 20201210 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46814 | Recruiting | No | | | | 15-12-2020 | 100 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | DR MANOJ RUNGHE→ | | KASHIBA AYURVED HOSPITAL OPD NO 3 K J INSTITUTE OF AYURVED AND RESEARCH SAVLI VADODARA K J INSTITUTE OF AYURVED AND RESEARCH SAVLI OPPOSITE
ITI SAVLI JAVLA VADODARA K J INSTITUTE OF AYURVED AND
RESEARCH SAVLI OPPOSITE ITI SAVLI JAVLA VADODARA
Vadodara
GUJ→ | principal.kjiar@kjit.org→ | 9687748944→ | K J INSTITUTE OF AYURVED AND RESEARCH AFFILATED TO KASHIBA AYURVED HOSPITAL SAVLI SAVLI VADODARA→ | Inclusion criteria: 1. RT-PCR Based Corona positive patient OR RAPID ANTIGEN TEST <br/ ><br>2. Consent to participate in the trial→ | Exclusion criteria: 1. Individual with uncontrolled unstable comorbidities <br/ ><br>2. Individual with pre- existing respiratory conditions <br/ ><br>3. Immunocompromised individuals or those on <br/ ><br>immunosuppressants <br/ ><br>4. Patients on or requiring parenteral nutrition <br/ ><br>5. Pregnant and lactating female→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: CAP ASMO: 2 CAP BID BEFORE MEAL WITH LUKE WARM WATER <br>DURATION 4 WEEKS<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | 1. Improvement in Bala of an individual <br/ ><br>2. Immuno- stimulation leading to <br/ ><br>non-development of Covid-19 in risk population <br/ ><br>exposed to infected individual <br/ ><br>Timepoint: ASSESSMENT AFTER 1 WEEK <br/ ><br>1. Improvement in Bala of an individual <br/ ><br>2. Immuno- stimulation leading to <br/ ><br>non-development of Covid-19 in risk population <br/ ><br>exposed to infected individual <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/12/029755 | 27 January 2021 | To assess symptoms and quality of life in post covid patients | Assessment and characterisation of symptoms and quality of life in post covid patients | | Khushboo Chahwala | 11-12-2020 | 20201211 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50254 | Not Recruiting | No | | | | 25-12-2020 | 50 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Anand k patel→ | | 206-TB Chest OPD,Department of Pulmonary Medicine,GMERS Medical college and hospital,Gotri,Vadodara 206-TB Chest OPD,Department of Pulmonary Medicine,GMERS Medical college and hospital,Gotri,Vadodara→ | dranandkpatel@gmail.com→ | 9879771079→ | GMERS Medical college and hospital, gotri→ | Inclusion criteria: Previously confirmed COVID positive by rapid antigen test or rtpcr swab test. <br/ ><br>Completed 1 month after positive test. <br/ ><br>Willing to participate and give consent.→ | Exclusion criteria: Patients having malignancy and other chronic conditions. <br/ ><br>Patients living with HIV aids.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To assess characteristics and clinical features in patients recovered from covid-19 patientsTimepoint: 7 months→ | | | | Yes | False | | |
| → | CTRI/2020/12/029743 | 27 January 2021 | Analysing effect of COVID 19 on mental health of frontline healthcare workers | Impact of COVID 19 on mental health of frontline healthcare workers in India | | Max Smart Super Speciality Hospital | 11-12-2020 | 20201211 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48997 | Not Recruiting | No | | | | 21-12-2020 | 246 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Nandani Gulati→ | | OPD A2, Department of Pulmonary and Sleep Medicine, Ground Floor, Max Smart Super Speciality Hospital, Press Enclave Marg, Saket → | nandanigulati@gmail.com→ | 9158987170→ | Max Smart Super Speciality Hospital→ | Inclusion criteria: 1. Healthcare workers (Doctors and Nurses) in hospitals taking care of COVID 19 patients <br/ ><br>2. Able and willing to provide informed consent. <br/ ><br>→ | Exclusion criteria: Participants who meet any of the following criteria: <br/ ><br>Previously diagnosed case of any mental health disorders <br/ ><br> <br/ ><br>→ | | Intervention1: Not applicable: Not applicable<br>→ | 9-item Patient Health Questionnaire Score <br/ ><br>7-item Generalized Anxiety Disorder Score <br/ ><br>7-item Insomnia Severity Index <br/ ><br>Perceived Stress Scale Score <br/ ><br>Timepoint: At Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/12/029733 | 27 January 2021 | To Assess CT Chest finding of Post-covid Pneumonia Patient
| To Assess CT Chest finding of Post-covid Pneumonia Patient
| | Dr Nil Patel | 11-12-2020 | 20201211 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50279 | Not Recruiting | No | | | | 25-12-2020 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Anand Patel→ | | 206-TB Chest OPD,Department Of Pulmonary Medicine,Gmers Medical College And Hospital,OLD TB Hospital Campus,Gotri,Vadodara → | dranandkpatel@gmail.com→ | 9879771079→ | Gmers Medical College And Hospital,Gotri,Vadodara→ | Inclusion criteria: Age > 18 years <br/ ><br>Willing to participate and give consent <br/ ><br>Confirm Covid Positive by RTPCR or Rapid Antigen Test <br/ ><br>All Patients Recovered from Covid 19 Positive Pneumonia after 1 months <br/ ><br>→ | Exclusion criteria: Age < 18 years <br/ ><br>HIV/AIDS <br/ ><br>Active and Old Pulmonary kochâ??s <br/ ><br>Malignancy <br/ ><br>Bronchiectasis <br/ ><br>ILD and other Chronic Respiratory Condition <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Not Applicable: Not Applicable<br>Intervention2: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | To Assess CT Chest finding of Post-covid Pneumonia PatientTimepoint: 6 Months→ | | | | Yes | False | | |
| → | CTRI/2020/12/029735 | 27 January 2021 | A Study to Assess the Safety and Efficacy of CoroQuil-Zn 750 in Comparison to the Standard of Care for the Treatment of Mild to Moderate COVID-19. | An Open-Label, Two-Arm, Parallel Design, Prospective, Single-Center, Phase 3 study to assess the safety and efficacy of CoroQuil-Zn in comparison to the standard of care for the treatment of mild to moderate COVID-19 | | Remedium Therapeutics Private Limited | 11-12-2020 | 20201211 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48763 | Recruiting | No | | | | 15-12-2020 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | Disha Shetty→ | | #1278, 25th main road, 40th Cross Road,
9th Block, Jayanagar, Bengaluru → | sri@samahitha.com→ | 9742797117→ | Samahitha Research Solutions→ | Inclusion criteria: 1. Written signed and dated informed consent (patient or LAR). <br/ ><br>2. Both genders, aged â?¥18 to â?¤75 years, <br/ ><br>3. Patients with RT-qPCR confirmed COVID-19 patients <br/ ><br>4. SpO2â?¥90% and respiratory rate â?¤30/minute <br/ ><br>5. Healthy adult patients with ASA I to II <br/ ><br>6. A score of between 3 to 5 on the Modified WHO Ordinal Scale for Clinical Improvement (refer protocol appendix 23.1) <br/ ><br>7. Patients who agree to abide by the study requirements <br/ ><br>→ | Exclusion criteria: 1. Pregnant and lactating women <br/ ><br>2. Children <18 yrs. of age; elderly >75 years <br/ ><br>3. SpO2 <90% for adults and respiratory rate >30/minute <br/ ><br>4. Patients having persistent nausea/vomiting <br/ ><br>5. Need for direct admission to the intensive care unit for mechanical ventilation <br/ ><br>6. Underlying chronic obstructive pulmonary disease stage III-IV <br/ ><br>7. Patients simultaneously participating in another clinical study. <br/ ><br>8. History of stroke with significant neurologic deficit. <br/ ><br>9. Patients with any concurrent pre-existing severe/uncontrolled, clinically significant systemic disease [e.g. heart failure (NYHA 2 or above)], cancer, liver disease, kidney disease or anaemia etc.) that, in the opinion of investigator precludes the subjectâ??s participation in the study or interferes with the interpretation of the study results. <br/ ><br>10. Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus. <br/ ><br>11. Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study <br/ ><br>12. A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: CoroQuil-Zn 750mg: 750mg x 2, administered orally three times a day for 14 days<br>Control Intervention1: COVID Standard Care: As per the sites COVID SOP<br>→ | Negative result for qRT-PCR testing for COVIDTimepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2020/12/029754 | 27 January 2021 | study of clinical and radiological presentation among covid-19 hospitalised patients based on covid swab tests | A study of clinical and radiological correlation with RTPCR and CBNAAT (Catridge based nucleic acid amplification tests) tests among hospitalised COVID-19 patients | | Dr Swathy Moorthy | 11-12-2020 | 20201211 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50080 | Not Recruiting | No | | | | 28-12-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Swathy Moorthy→ | | Department of General Medicine, Sri Ramachandra Medical COllege, SRIHER, Porur, Chennai → | drswathymoorthy@sriramachandra.edu.in→ | 9444016401→ | Sri Ramachandra University→ | Inclusion criteria: 1. All cases were diagnosed with COVID 19 infection based on the clinical manifestations <br/ ><br>2. Confirmed by RT-PCR or CBNAAT: 2019 novel coronavirus in nasal and pharyngeal swab specimens. <br/ ><br>3. individuals who are swab negative but radiologically have a strong suspicion of covid-19 <br/ ><br>4. Individuals with lung disorders, cardiovascular disorder, stroke, diabetes, hypertension, obesity, endocrine disorders as co morbid conditions are included <br/ ><br>→ | Exclusion criteria: 1. Patients with Common bacteria or viruses associated with community-acquired pneumonia. <br/ ><br>2. Patients under the age of 18 years with or without COVID-19 infection <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: nil: nil<br>Control Intervention1: nil: nil<br>→ | Clinical and Radiological severity assessment of swab positive and negative covid-19 patientsTimepoint: at baseline→ | | | | Yes | False | | |
| → | CTRI/2020/12/029744 | 27 January 2021 | Analysing impact of pre-existing comorbidities on serious adverse outcomes in hospitalised COVID19 patients | Comparison of the risk of serious adverse outcomes and clinical, laboratory and radiological characteristics in stable patients hospitalized with COVID 19 divided by co morbidity status | | Max Smart Super Speciality Hospital | 11-12-2020 | 20201211 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49072 | Not Recruiting | No | | | | 21-12-2020 | 128 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Nandani Gulati→ | | OPD A2, Department of Pulmonary and Sleep Medicine, Ground Floor, Max Smart Super Speciality hospital, Press Enclave Marg, Saket, Delhi → | nandanigulati@gmail.com→ | 9158987170→ | Max Smart Super Speciality Hospital→ | Inclusion criteria: Patients testing positive for SARSCoV2 by rRTpcr on a nasopharyngeal or oro pharyngeal swab <br/ ><br>Hemodynamically stable patients getting admitted to ward <br/ ><br>Able and willing to provide informed consent <br/ ><br>→ | Exclusion criteria: Patients who meet any of the following criteria: <br/ ><br> <br/ ><br>1. Critically ill patients defined as those <br/ ><br>a. Requiring ICU admission <br/ ><br>b. Requiring mech ventilation <br/ ><br>c. Radiographic imaging with severe bilateral ground glass opacities or consol-idation <br/ ><br>d. ARDS with PaO2/FiO2 300mm Hg or less <br/ ><br>e. Septic Shock requiring vasopressors <br/ ><br>f. Altered consciousness <br/ ><br>g. Multi organ failure as evidenced by CrCL <30 ml/min or receiving HD, CVVH or ALT > 5x upper limit of normal <br/ ><br> <br/ ><br>2. Patients not giving informed consent. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | Shifted to ICU <br/ ><br>Invasive mechanical ventilation <br/ ><br>Death <br/ ><br>Timepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2020/12/029745 | 27 January 2021 | Efficacy of Homoeopathic prophylaxis Arsenicum Album against COVID-19 | Efficacy of Homoeopathic prophylaxis Arsenicum Album against COVID-19 (EPAC): A Cluster randomized controlled trial. - EPAC | | School of Public Health SRMIST | 11-12-2020 | 20201211 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49613 | Not Recruiting | No | | | | 12-12-2020 | 15000 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Other Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | N/A | India→ | Prof Padma Venkat→ | | The Dean
School of Public Health,
3rd Floor Medical College Building, SRM Nagar, SRM Institute of Science and Technology(SRM University), Kattankulathur → | alexj@srmist.edu.in→ | | School of Public Health SRMIST→ | Inclusion criteria: Participants who are capable of giving signed informed consent. <br/ ><br>6 months and older individuals in the study area, <br/ ><br>The participant is in good health in the opinion of the investigator as determined by a medical and psychiatric history. <br/ ><br>The participant must be willing and able to comply with study restrictions, to remain <br/ ><br>at the study area for the required duration during the study period and be available for <br/ ><br>the follow-up evaluations, as specified in this protocol. <br/ ><br> <br/ ><br>→ | Exclusion criteria: COVID-19 positive as determined by RT-PCR, or other approved commercial or public health assay. Children less than 6 months <br/ ><br>Severe chronic kidney disease or cardiovascular diseases, cancer, AIDS or other life-threatening diseases. <br/ ><br>Immunocompromised patients taking (presently or anytime during last 90 days) immunosuppressant medication <br/ ><br>The person has participated in a clinical study of a new chemical entity or a prescription medicine within 3 months before administration of the first dose of the IMP <br/ ><br>The patient cannot participate or successfully complete the study, in the opinion of their healthcare provider or the investigator for any of the following reasons <br/ ><br>mentally or legally incapacitated or unable to give consent for any reason o unable to be contacted in case of emergency <br/ ><br>The patient is an employee of the sponsorparticipating study center who is directly involved in the study or is the relative of such an employee <br/ ><br>The patient has a history of alcohol and/or drug abuse that in the investigatorâ??s opinion could interfere with the study evaluations or the patientâ??s safety has any other condition, which, in the opinion of the investigator makes the patient inappropriate for inclusion in the study <br/ ><br> <br/ ><br>→ | | Intervention1: Arsenicum Album: Dose - 30 C potency <br>Frequency -3 pill in the morning in a day. <br>Route of administration - Oral Duration of therapy - 3 days <br><br>Dose - 200 C potency <br>Frequency -3 pill in the morning in a day. <br>Route of administration - Oral Duration of therapy - 3 days<br>Control Intervention1: Placebo: Dose - Blank Pills<br>Frequency -3 pill in the morning in a day. <br>Route of administration - Oral Duration of therapy - 3 days<br>→ | The primary outcome <br/ ><br>A reduction in attack rate of Covid19 in the intervention arm were prophylaxis <br/ ><br>Arsenicum Album is administered compared to control arm.Timepoint: The recruitment will start from 12-12-2020 and the it will end on 12-01-2021. <br/ ><br> <br/ ><br>The surveillance will start from 20-12-2020 and end by 20-01-2021→ | | | | Yes | False | | |
| → | CTRI/2020/12/029761 | 27 January 2021 | what happens when a patient having connective tissue disease develops covid 19 infection. | Covid-19 outcome in patients with Connective Tissue Disease with or without Interstitial Lung Disease. | | PRATIMA SINGH | 11-12-2020 | 20201211 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49404 | Not Recruiting | No | | | | 12-12-2020 | 30 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Pratima Singh→ | | DEPT. OF RESPIRATORY MEDICINE, KIMS, CAMPUS-5, KIIT UNIVERSITY, PATIA, BHUBANESWAR. KIMS STAFF QRS, KIIT UNIVERSITY→ | drppratima@gmail.com→ | 8895613285→ | KALINGA INSTITUTE OF MEDICAL SCIENCES→ | Inclusion criteria: -All cases of Connective Tissue Disease with interstitial lung disease associated with Covid19 infection <br/ ><br>-All cases of Connective Tissue Disease without interstitial lung disease associated with Covid19 infection→ | Exclusion criteria: 1. Co-morbidity like Chronic Kidney Disease,Chronic Liver Disesase. <br/ ><br> <br/ ><br>2. Patient who does not give consent for study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | CT THORAX SEVERITY SCORETimepoint: 0 AND 12WEEKS→ | | | | Yes | False | | |
| → | CTRI/2020/12/029780 | 27 January 2021 | Mental health impact of COVID-19 pandemic on PMNS cohort | Explaining Resilience and Vulnerability to the impact on mental health of the Covid-19 pandemic in the Pune Maternal Nutrition Study birth cohort | | Diabetes Unit | 14-12-2020 | 20201214 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49510 | Not Recruiting | No | | | | 26-12-2020 | 370 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rishikesh V Behere→ | | 6th floor, Banoo Coyaji bldg, KEM Hospital Research Center
489, Rastapeth, Sardar Moodliar Road
Pune → | rvbehere@gmail.com→ | | Diabetes Unit→ | Inclusion criteria: Participants of the PMNS cohort, who have undergone pre-pandemic psychological and mental health evaluation→ | Exclusion criteria: Only those subjects who have the capacity to be interviewed will be included in the study.→ | | | Assessing the COVID-19 pandemic experience of the participants of the cohort and the current level and nature of distress and mental health problems.Timepoint: single time point→ | | | | Yes | False | | |
| → | CTRI/2020/12/029773 | 27 January 2021 | Establishment of a Indo-US Molecular Biomarker Knowledge Network for COVID-19 | Establishment of a Indo-US Molecular Biomarker Knowledge Network for COVID-19 | | IndoUS Science and Technology Forum IUSSTF | 14-12-2020 | 20201214 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50309 | Not Recruiting | No | | | | 23-12-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Shantikumar V Nair→ | | Amrita Institute of Medical Sciences and Research Centre, AIMS, Ponekkara P O, Kochi → | shantinair@aims.amrita.edu→ | 9895558597→ | Amrita Centre for Nanosciences and Molecular Medicine, Amrita Institute of Medical Sciences→ | Inclusion criteria: In the inclusion criteria, both asymptomatic and symptomatic patients (mild, moderate, severe and critical) will be evaluated for identification of biomarkers→ | Exclusion criteria: Patients who comes below 15 years and above 70 years will be excluded from the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Establishing the relationship between the host response severity and bio-molecular factors (exposome, proteome, immunity factors) in patients infected with SARS-Cov2. This will help in the identification of a set of biomarkers which are found in the symptomatic and asymptomatic subjects for the prognostication of different stages of the diseaseTimepoint: October 2021→ | | | | Yes | False | | |
| → | CTRI/2020/12/029772 | 27 January 2021 | Effect of malaria or dengue in COVID-19 patients. | Clinical Presentations and treatment outcomes in COVID-19 patients with Co-infection of Vector Borne Diseases (Malaria or Dengue) in TNMC and BYL Nair Charitable Hospital | | DrNiraj Mahajan | 14-12-2020 | 20201214 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50363 | Not Recruiting | No | | | | 21-12-2020 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrNiraj Mahajan→ | | Department of Obstetrics and Gynaecology, Fourth floor, college building
Mumbai
Maharashtra → | nirajdr@hotmail.com→ | 09004696920→ | TNMC and BYL Nair hospital→ | Inclusion criteria: Medical case records of patients with Co-infection of malaria and dengue with COVID-19 admitted at Nair hospital from 1st March till 30th October 2020.→ | Exclusion criteria: Pregnant females will be excluded.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: A90- Dengue fever [classical dengue]
Health Condition 4: B50- Plasmodium falciparum malaria
Health Condition 5: B51- Plasmodium vivax malaria
→ | Control Intervention1: Nil: Nil<br>→ | 1. Socio-demographic, epidemiological and clinical characteristics of patients with co-infection of malaria or dengue with COVID-19. 2.Viral clearance of SARS-CoV-2 infection. 3.Outcomes in patients. 4.Response to treatment. 5. Reinfection or readmission will be analysed.Timepoint: 8 months→ | | | | Yes | False | | |
| → | CTRI/2020/12/029783 | 27 January 2021 | nintedanib therapy will improve management in covid 19 fibrosis if given early or not. | Therapy with nintedanib â??Does it improve outcome in patients of Covid-19 pneumonia if given early?
| | PRATIMA SINGH | 14-12-2020 | 20201214 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49405 | Not Recruiting | No | | | | 14-12-2020 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Pratima Singh→ | | DEPT.OF RESPIRATORY MEDICINE,KIMS,CAMPUS-5,KIIT UNIVERSITY,PATIA, BHUBANESWAR. → | drppratima@gmail.com→ | 8895613285→ | KALINGA INSTITUTE OF MEDICAL SCIENCES→ | Inclusion criteria: All cases of covid 19 pneumonia detected as COVID positive within â?¤ 30 days or with history and CT suggestive of covid 19 . <br/ ><br>CT-severity score â?¥15 and CORADS-4/5/6 <br/ ><br>→ | Exclusion criteria: -Patients having other interstitial lung diseases. <br/ ><br>- Patient having CKD or creatinine clearance <30 and CLD with deranged LFT will be excluded. <br/ ><br>-Not fulfilling the criteria for study <br/ ><br>-Not giving consent for study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NINTEDANIB 150 MG CAPSULE: NINTEDANIB 150 MG CAPSULE TO BE GIVEN BD FOR 12 WEEKS MAXIMUM.<br>Control Intervention1: NA: NA<br>→ | Improvement in CT thorax findings(CT severity score).Timepoint: 6WEEKS 12WEEKS.→ | | | | Yes | False | | |
| → | CTRI/2020/12/029805 | 27 January 2021 | Evaluating efficacy and safety of goggles with or without inbuilt fan in health care workers inside COVID ICU | Comparing efficacy and safety of indigenous goggles with fan versus standard goggles in health care workers in COVID ICU: A pilot study - GOFOG | | All India Institute of Medical Sciences Ansari Nagar New Delhi | 15-12-2020 | 20201215 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50445 | Not Recruiting | No | | | | 24-12-2020 | 30 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Navdeep Sokhal→ | | 710,
Department of Neuroanaesthesiology and Critical Care,
CN Center,
AIIMS, New Delhi → | drnavdeep_kumar@yahoo.com→ | 01126593474→ | AIIMS, New Delhi→ | Inclusion criteria: Health care workers in designated COVID Area→ | Exclusion criteria: 1.Past history of COVID infection (RT-PCR positive) <br/ ><br>2.Symptomatic health care worker with suspected COVID infection <br/ ><br>→ | | Intervention1: Indigenous goggles with fan: Healthcare workers going to designated COVID ICU will be wearing indigenous goggles with fan and efficacy and safety of these goggles will be recorded.<br>Control Intervention1: Standard goggles: Healthcare workers going to designated COVID ICU will be wearing standard goggles and efficacy and safety of these goggles will be recorded.<br>→ | To compare vision of health care worker while working in designated COVID area wearing fan powered goggles versus standard goggles <br/ ><br>a. Near Vision-ability to read patient file and notes <br/ ><br>b. Far vision- ability to read vital parameters on stationed patient monitors <br/ ><br>Timepoint: After shift duty for the day→ | | | | Yes | False | | |
| → | CTRI/2020/12/029812 | 27 January 2021 | Assessment of psychological outcomes in cancer patients during COVID-19 pandemic | Assessment of depression, anxiety, and stress in cancer patients during the COVID-19 pandemic in a comprehensive cancer centre in India | | Dr Jai Prakash Agarwal | 15-12-2020 | 20201215 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50458 | Not Recruiting | No | | | | 22-12-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr J P Agarwal→ | | Tata Memorial Center, Room no 1127, Homi Bhabha Block, Department of Radiation Oncology, Parel (east) → | agarwaljp@tmc.gov.in→ | 02224177000→ | Tata Memorial Center, Mumbai→ | Inclusion criteria: All patients registered at TMC, who are either being planned for or presently on active oncological treatment under any of the Clinical Disease Management Groups (DMGs) at Tata Memorial centre (TMH + ACTREC) <br/ ><br> <br/ ><br>1.COVID-non suspect group: From the target population, patients who have not been clinically suspected to have COVID-19 infection due to lack of symptoms, normal temperature record and no history of contact with COVID-19 positive case. <br/ ><br> <br/ ><br>2.COVID-suspect group: From the target population, patients who have been suspected to have COVID-19 infection and have been subsequently referred to the designated fever OPD for evaluation and swab testing for COVID-19→ | Exclusion criteria: 1.Patients not willing for participation and giving consent <br/ ><br> <br/ ><br>2.Patients unable to read/write in English, Hindi, Marathi or Bengali <br/ ><br> <br/ ><br>3.Patients who are on routine follow-up without any active anti-cancer treatment <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: D499- Neoplasm of unspecified behavior of unspecified site
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | To assess the emotional states of depression, anxiety and stress among cancer patients seeking treatment at TMCTimepoint: 1 year→ | | | | Yes | False | | |
| → | CTRI/2020/12/029803 | 27 January 2021 | Oxygen therapy in covid positive patients | A randomised controlled trial of high flow nasal oxygen versus non rebreathing oxygen face mask therapy in acute hypoxemic respiratory failure. | | Sri venkateswara institute of medical sciences | 15-12-2020 | 20201215 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49947 | Not Recruiting | No | | | | 25-12-2020 | 122 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Aloka Samantaray→ | | Flat No.03
SVIMS old Quarters
Sri venkateswara institute of medical sciences
Tirupati Department of Anaesthesiology
Sri venkateswara institute of medical sciences
Tirupati→ | aloksvims@gmail.com→ | 9493547653→ | Sri Venkateswara Institute of Medical Sciences→ | Inclusion criteria: All adult patients aged 18 years and above diagnosed as acute hypoxemic respiratory failure with covid positive status→ | Exclusion criteria: facial abnormalities <br/ ><br>non cardiogenic pulmonary oedema <br/ ><br>patients who do not give consent→ | Health Condition 1: J960- Acute respiratory failure
Health Condition 2: J128- Other viral pneumonia
→ | Intervention1: High flow nasal oxygen cannula and non rebreathing oxygen face mask: High flow nasal oxygen delivers Fio2 100% at flow rate of 60LPM Non rebreathing oxygen face mask delivers Fio2 100% at 15 LPM<br>Control Intervention1: High flow nasal oxygen cannula and non rebreathing oxygen face mask: High flow nasal oxygen delivers Fio2 100% at flow rate of 60LPM<br>Non rebreathing oxygen face mask delivers Fio2 100% at 15 LPM.<br>→ | patients with treatment failure (those who need NIV support)Timepoint: Any point of time during course of treatment in ICU stay.→ | | | | Yes | False | | |
| → | CTRI/2020/12/029814 | 27 January 2021 | comparison of two drugs for better treatment of covid-19 related lung problems | Nintedanib Vs Pirfenidone in management of Covid19 related lung abnormality | | PRATIMA SINGH | 15-12-2020 | 20201215 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49778 | Not Recruiting | No | | | | 16-12-2020 | 30 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Deepak Sahoo→ | | CIRS, BILIPADA, PS-PIPILI, DIST-PURI. CIRS, PLOT NUMBER F-10, BJB NAGAR, BHUBANESWAR , 751014.→ | drppratima@gmail.com→ | 8895613285→ | KALINGA INSTITUTE OF MEDICAL SCIENCES→ | Inclusion criteria: All cases of covid 19 pneumonia who were diagnosed as COVID positive â?¥15 days back or antibody positive and continue to be breathless symptomatically, have SPo2 â?¤96%, CT-severity score â?¥10 and CORADS-4/5/6→ | Exclusion criteria: -Patients having other interstitial lung diseases. <br/ ><br>- Patient having CKD or creatinine clearance <30 and CLD with deranged LFT will be excluded. <br/ ><br>-Not fulfilling the criteria for study <br/ ><br>-Not giving consent for study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NINTEDANIB: 150 MG CAPSULE TO BE GIVEN BD FOR A DURATION OF 12 WEEKS MAXIMUM.<br>Control Intervention1: tab pirfenidone 600 mg tid: 600 MG TAB TO BE GIVEN TID FOR A DURATION OF 12 WEEKS MAXIMUM. <br>→ | Improvement in CT-severity score <br/ ><br>Improvement in Arterial Blood Gas. <br/ ><br>Timepoint: 0, 6weeks, 12weeks→ | | | | Yes | False | | |
| → | CTRI/2020/12/029815 | 27 January 2021 | Ventilatory strategies in severe SARS coV 2 and their outcome | Ventilatory strategies in severe SARS coV 2 and their outcome | | K S Hegde medical Academy | 15-12-2020 | 20201215 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48761 | Not Recruiting | No | | | | 16-12-2020 | 60 | Observational | Other<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | Dr Siri Kandavar→ | | Department of Anaesthesiology
k S Hegde Medical Academy
Nitte Deemed to be university
Deralakatte ,
Mangalore → | sirikandavar16@gmail.com→ | 0824-2204471→ | K S Hegde medical Academy→ | Inclusion criteria: all the patients admitted in ICU with covid Positive reuiring oxygen support→ | Exclusion criteria: all non covid patients→ | Health Condition 1: -
Health Condition 2: A00-B99- Certain infectious and parasitic diseases
→ | | outcome of different ventilatory strategiesTimepoint: outcome of different ventilatory strategies→ | | | | Yes | False | | |
| → | CTRI/2020/12/029793 | 27 January 2021 | The use of tocilizumab in patients with severe COVID 19 pneumonia - a trial to know its efficacy in those on steroids | Efficacy and safety of tocilizumab in patients with severe COVID-19 pneumonia on steroid therapy: A prospective, randomized, double blind placebo-controlled trial | | Naveen Naik B | 15-12-2020 | 20201215 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50303 | Not Recruiting | No | | | | 31-12-2020 | 54 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 3 | India→ | Naveen Naik B→ | | Department Of Anaesthesia and Intensive Care, Fourth floor, Nehru Hospital, PGIMER, Chandigarh. → | navin_amc@yahoo.com→ | 8872377925→ | Post Graduate Institute of Medical Education and Research→ | Inclusion criteria: 1. Patients 18 years or older <br/ ><br>2. Diagnosis of SARS-CoV-2 infection by RT-PCR <br/ ><br>3. Pulmonary infiltrates on CXR/ CECT Chest <br/ ><br>4. On COVID specific steroid therapy with IV methyl prednisolone 1 mg/kg/day or dexamethasone 6 mg per day <br/ ><br>5. Severe respiratory failure with PaO2 / FiO2 less than 150 mmHg and IL-6 > 50 pg/mL with CRP > 50 mg/L <br/ ><br>6. Signature of informed consent by the patient, family member or legal representative <br/ ><br>→ | Exclusion criteria: 1.Less than 24 hrs of initiation of steroid therapy <br/ ><br>2. Liver injury or failure (AST/ALT â?¥ 5x Upper limit of normal) <br/ ><br>3. Leukocytes < 2 Ã? 103/μl <br/ ><br>4. Thrombocytes < 50 Ã? 103/μl <br/ ><br>5. Severe bacterial infection (Procalcitonin > 3ng/ml) <br/ ><br>6. Acute or chronic diverticulitis <br/ ><br>7. Immunosuppressive therapy (e.g. mycophenolate, azathioprine, methotrexate and biologicals) <br/ ><br>8. Known active or chronic tuberculosis <br/ ><br>9. Known active or chronic viral hepatitis <br/ ><br>10. Known allergic reactions to tocilizumab or its ingredients <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tocilizumab: Administration of 8mg/kg body weight (BW) Tocilizumab i.v. immediately after<br>randomisation (total dose should not exceed 800mg) (single dose will be administered after randomisation) AND<br>â?¢ Conventional treatment (until discharge from the ICU)<br><br><br>Control Intervention1: Normal Saline: Normal Saline will be used as placebo.Placebo i.v. immediately after randomisations (single dose) AND<br>â?¢ Conventional treatment (until discharge from the ICU)<br><br>→ | Ventilator free days (VFD) in the first 28 days, after randomisationTimepoint: 28 days after randomisation→ | | | | Yes | False | | |
| → | CTRI/2020/12/029841 | 27 January 2021 | Comparison of a techniques named goal directed therapy with clinician guided regime for fluid management in COVID -19 critical care unit | Goal directed therapy guided by pulse pressure variation vs standard care for fluid management in COVID-19 critical care unit: a pilot randomised controlled trial | | Department of OncoAnaesthesia and Palliative Medicine | 16-12-2020 | 20201216 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48427 | Not Recruiting | No | | | | 18-12-2020 | 20 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded | N/A | India→ | Dr Sushma Bhatnagar→ | | Room No. 242, Second floor,
Dr BRAIRCH, Department of
Onco-Anaesthesia and Palliative Medicine, All India Institute of
Medical Sciences, Ansari Nagar, New Delhi
India → | khushboo0411@gmail.com→ | 9888530182→ | All India Institute of Medical Sciences, Ansari Nagar, New Delhi→ | Inclusion criteria: Laboratory confirmed cases of COVID-19 with severe hypoxemia, requiring invasive mechanical ventilation→ | Exclusion criteria: a) age <18 years <br/ ><br>b) k/c/o CAD/ cardiac rhythm disorder <br/ ><br>c) BMI > 40 kg/m2 <br/ ><br>d) pregnant patients <br/ ><br>e) patients with coagulopathy/ bleeding disorder <br/ ><br>f) patients with motor/ neuromuscular disorder <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Group II (Goal directed therapy group) : fluid therapy will be guided by dynamic parameters i.e. maintaining pulse pressure variation (PPV) less than 10%.: Group II (Goal directed therapy group) Fluid therapy will be guided by dynamic parameters i.e. maintaining Pulse Pressure Variation (PPV) less than 10%. PPV will be measured through the cardiac monitor attached to the arterial catheter.<br>Control Intervention1: Group 1 (Standard care group)- intravenous fluids will be administered as per the treating physicianâ??s clinical judgement.: Group 1 (Standard Care Group)- intravenous fluids will be administered as per the treating physicianâ??s clinical judgement, 1-2 ml/kg/hour with monitoring of clinical signs for euvolemia, adequate urine output and skin turgor.<br>→ | To evaluate the effect of two strategies for fluid therapy (goal directed therapy vs standard care) on tissue perfusion as measured by serum lactate in mechanically ventilated COVID-19 patients <br/ ><br>Timepoint: 48 hours→ | | | | Yes | False | | |
| → | CTRI/2020/12/029847 | 27 January 2021 | A study to see the result of planned cancer surgery in COVID-19 survivors | Outcomes of elective cancer surgery in COVID-19 survivors: An observational study | | Tata Memorial Hospital | 16-12-2020 | 20201216 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50526 | Not Recruiting | No | | | | 01-01-2021 | 600 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Priya Ranganathan→ | | Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai → | jdivatia@yahoo.com→ | 9869077435→ | Tata Memorial Centre→ | Inclusion criteria: 1. patients with a confirmed diagnosis of cancer <br/ ><br>2. and a confirmed COVID diagnosis (by RT PCR) <br/ ><br>3. who were planned to undergo surgery as part of their cancer treatment plan→ | Exclusion criteria: Patients with clinical or radiological suspicion of COVID without a positive RT PCR test will be excluded→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | In COVID-recovered cancer patients who underwent surgery <br/ ><br>1. 30 day all-cause mortality <br/ ><br>2. 30-day morbidity (as per Clavien Dindo classification) <br/ ><br>3. Correlation of mortality and morbidity with severity of COVIDTimepoint: 30 days post surgery→ | | | | Yes | False | | |
| → | CTRI/2020/12/029855 | 27 January 2021 | Phase III, Randomized, Controlled, Open-Label Study of
Pegylated Interferon Alfa-2b With SARS-CoV-2 | A Phase III, Randomized, Controlled, Open-Label Study
to Evaluate the Efficacy and Safety of Pegylated
Interferon Alfa-2b In the Treatment of Adult Patients
Diagnosed With SARS-CoV-2 (COVID-19). | | Zydus Research Center Cadila Healthcare Limited | 16-12-2020 | 20201216 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49858 | Recruiting | No | | | | 28-12-2020 | 250 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | Dr Balaji More→ | | Zydus Research Center,
Survey No. 396/403,
Sarkhej-Bavla National Highway No.8A Moraiya,
Ahmedabad - 382213 → | kevinkumarkansagra@zyduscadila.com→ | | Cadila Healthcare Limited→ | Inclusion criteria: 1. Ability to comprehend and willingness to sign a written ICF for the study. <br/ ><br>2. Male or non-pregnant females, â?¥18 years of age at the time of enrolment. <br/ ><br>3. Understands and agrees to comply with planned study procedures. <br/ ><br>4. Agrees to the collection of pharyngeal swabs and blood sample as per protocol. <br/ ><br>5. Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR within 5 days of <br/ ><br>enrollment. <br/ ><br>6. Patients with pneumonia with no signs of severe disease, respiratory rate â?¥24breaths/minute, <br/ ><br>SpO2 90%- 94%. <br/ ><br>7. Illness of any duration, and at least one of the following: <br/ ><br>a. Radiographic infiltrates by imaging (chest x-ray/CT scan) <br/ ><br>b. Clinical assessment (evidence of rales/crackles or other clinical symptoms related to COVID-19 on examination). <br/ ><br>8. Women of childbearing potential must agree to use at least one primary form of contraception <br/ ><br>for the entire duration of the study (acceptable methods will be determined by the site).→ | Exclusion criteria: 1. ALT/AST >5 times the upper limit of normal. <br/ ><br>2. Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR <30). <br/ ><br>3. Pregnant or breast feeding. <br/ ><br>4. Allergy to any study medication. <br/ ><br>5. Severe co-morbidity (e.g. uncontrolled hypertension and uncontrolled DM, systemic disease which affect the vital organs severity, immunocompromised patients etc.) as per investigatorâ??s assessment. <br/ ><br>6. Comorbid condition like myocardial infarction or heart failure within 90 days of recruitment. <br/ ><br>7. Prolong QT interval ( >450 ms).→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Pegylated IFN-α2b and Standard of care: Single dose of Pegylated IFN-<br>α2b (1 mcg/kg) along with the<br>recommended standard of care<br>at the time of conduct of trial.<br>Control Intervention1: Standard of care: recommended standard of<br>care at the time of conduct of<br>trial.<br>→ | Evaluation of the clinical efficacy of Pegylated interferon alfa-2b on the basis of change in ordinal <br/ ><br>scale at Day 11 ± 1.Timepoint: baseline to Day 11→ | | | | Yes | False | | |
| → | CTRI/2020/12/029869 | 27 January 2021 | Effectiveness of Siddha Medicines on COVID-19 patients | Effectiveness of Siddha Herbal Formulations
(Notchi Kudineer and Chitrarathai Kudineer) on
SARS-CoV-2 infection among
asymptomatic infected patients
- COSID | | MINISTRY OF AYUSH GOVERNMENT OF INDIA | 16-12-2020 | 20201216 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50422 | Not Recruiting | No | | | | 04-01-2021 | 90 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | N KABILAN→ | | Professor and Head
Department of Siddha
Fourth Floor
Main Building
The Tamil Nadu Dr.M.G.R. Medical University
69 Anna Salai
Guindy
Chennai Professor and Head
Department of Siddha
Fourth Floor
Main Building
The Tamil Nadu Dr.M.G.R. Medical University
69 A→ | kabilan.n@tnmgrmu.ac.in→ | 9444018139→ | The Tamil Nadu Dr.M.G.R. Medical University→ | Inclusion criteria: A person diagnosed with COVID-19 in the past 48 hours and undergoing treatment at Government Chengalpattu Medical College, Tamilnadu→ | Exclusion criteria: Chronic lung disease with chronic hypoxia <br/ ><br>ï?· Sleep apnea requiring BIPAP / continuous positive airway pressure <br/ ><br>ï?· Other conditions which are considered not suitable for herbal drug trial as allergic to herbal medicine etc <br/ ><br>ï?· Pregnancy <br/ ><br>ï?· People who are part of other COVID-19 trials→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B998- Other infectious disease
→ | Intervention1: Notchi Kudineer<br>Arathai Kudineer: Decoction to be given 60 ml dose, thrice a day, for 14 days<br>Intervention2: Notchi Kudineer<br>Standard of care: Siddha Herbal Decoction<br>60 ml thrice a day for 14 days<br>Standard of care by conventional modern medicine in a government medical college<br>Intervention3: Arathai kudineer<br>Standard of care: Siddha Herbal Decoction<br>60 ml thrice a day for 14 days<br>Standard of care by conventional modern medicine in a government medical college<br>Control Intervention1: Standard of care: Standard of care by conventional modern medicine in a government medical college<br>→ | Reduction in severity of symptoms <br/ ><br>ï?· Status of infection â?? Positive /Negative - through (SARS-CoV-2 / COVID-19) N-Protein IgM / IgG antibodies in human serum, whole blood, or finger prick samples <br/ ><br>Timepoint: 5 days→ | | | | Yes | False | | |
| → | CTRI/2020/12/029873 | 27 January 2021 | Professional quality of life in health care workers of ICUs during COVID-19 pandemic | Assessment of professional quality of life during COVID-19 pandemic in health care workers working in intensive care units | | Maulana Azad Medical College and associated Lok Nayak Hospital | 17-12-2020 | 20201217 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50567 | Not Recruiting | No | | | | 24-12-2020 | 323 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sukhyanti kerai→ | | Rom no 413, 4th floor, BL Taneja block, MAMC Campus, Bahadur Shah Zafar Marg → | drsukhi25@gmail.com→ | 09968527122→ | Maulana Azad Medical College→ | Inclusion criteria: Doctors and nursing staffs involved in direct care of critically ill COVID-19 patients→ | Exclusion criteria: HCWs providing indirect care (administrative management, indirect services such as housekeeping, laboratory services) to patients and those who have been posted in ICUs a total duration of less than 30 days will be excluded→ | | | prevalance of burnout, compassion satisfaction and secondary traumatic experiences in ICU health workersTimepoint: Cross sectional study on 7 days after enrollment of participants→ | | | | Yes | False | | |
| → | CTRI/2020/12/029887 | 27 January 2021 | Comparison of anaesthesia management and procedures during COVID 19 time and one year before | Quantitative analysis of loss of anaesthesia management opportunities & procedural skills due to COVID19 pandemic lockdown: An experience of six months from a single onco-surgical teaching Institute | | Dept of Anaesthesia Critical Care and Pain | 17-12-2020 | 20201217 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50575 | Not Recruiting | No | | | | 01-01-2021 | 600 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sagar Pargunde→ | | Dept. of Anaesthesia, Critical Care and Pain, Second floor, Main Building, Tata Memorial Hospital → | anjanawajekar@gmail.com→ | 9930104106→ | Tata Memorial Centre→ | Inclusion criteria: Data from all the elective surgical procedures requiring anaesthesia services, conducted from 23 march 2019 to 22 septemer 2019 and 23 mar 2020 to 22 september 2020,in TATA memorial centre & ACTREC <br/ ><br>Both adult and pediatric patients ( <12 years) will be included. All surgeries & procedures requiring general anesthesia (GA), Regional anesthesia (RA) and monitored anesthesia(MAC) care will be included <br/ ><br>→ | Exclusion criteria: All emergency surgeries and surgeries performed under local anesthesia→ | Health Condition 1: O- Medical and Surgical
Health Condition 2: C00-D49- Neoplasms
→ | Intervention1: NA: NA<br>Control Intervention1: NA: NA<br>→ | To assess the deficit in the total number of elective surgeries requiring anesthesia management in the said durationTimepoint: Post 6 months analysis→ | | | | Yes | False | | |
| → | CTRI/2020/12/029884 | 27 January 2021 | response to an upcoming COVID 19 vaccine about how an individual looks towards it. | Survey Study For Accessing The Willingness, Enthusiasm And Readiness Of Population For COVID-19 Vaccine
| | Dr Prashant Kumar Gupta | 17-12-2020 | 20201217 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50596 | Not Recruiting | No | | | | 26-12-2020 | 1500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr prashant Kumar Gupta→ | | Room No -07,
Division - Department of kaumarbhritya,
Shri NPA Govt Ayurveda College,
Raipur, Chhattisgarh G E Road, Raipur→ | prashantgupta27@gmail.com→ | 09990988860→ | Shri NPA Govt Ayurveda College→ | Inclusion criteria: willing to be respondent→ | Exclusion criteria: not willing to be respondent→ | | Control Intervention1: NIL: NIL<br>→ | recognizing variables for Covid vaccine preparedness, enthusiasm and readinessTimepoint: December-january→ | | | | Yes | False | | |
| → | CTRI/2020/12/029885 | 27 January 2021 | Comparison of transport media s for detecting COVID-19 positivity. | Comparison of viral transport media(VTM) versus molecular transport media(MTM) for detecting COVID-19 positivity (VTMT Study). - VTMT Study | | Tata Memorial Centre | 17-12-2020 | 20201217 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50606 | Not Recruiting | No | | | | 28-12-2020 | 394 | Interventional | Randomized, Crossover Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Amit Joshi→ | | Room No 210, Medical Oncology OPD, Paymaster Shodhika (PS), ACTREC Tata memorial Centre, Sector -22, Kharghar, Navi Mumbai, 410210 Tata Memorial Hospital, Parel→ | dramitjoshi74@gmail.com→ | 022-2740500→ | Tata Memorial Hospital→ | Inclusion criteria: 1. Age â?¥ 18 years. <br/ ><br>2. Asymptomatic patient planned for cancer surgery or any other procedure requiring general anaesthesia (DL Scopy/ cystoscopy/ PTBD/ PCN insertion). <br/ ><br>3. Asymptomatic patient planned for in patient multiday chemotherapy in ward. <br/ ><br>4. Symptomatic patient planned for COVID-19 swabbing by their treating physician. <br/ ><br>5. Symptomatic staff planned for COVID-19 swabbing by the staff physician. <br/ ><br>→ | Exclusion criteria: 1. Participant not willing to participate in the study. <br/ ><br>2. Participant on anticoagulation therapy or antiplatelet therapy for other ailments. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: VTM (Viral transport media): Viral transport media<br>Control Intervention1: MTM (Molecular Transport Media): Molecular Transport Media<br>→ | The difference between RT PCR COVID-19 positivity in samples transported in MTM and VTM media.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/12/029882 | 27 January 2021 | Socio demographic profile and clinical outcome in COVID 19 in a tertiary care hospital -A Retrospective study | Socio-Demographic profile and clinical outcomes in COVID 19 in a tertiary care hospital -A Retrospective study | | SRM Institutues for Medical Science | 17-12-2020 | 20201217 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50155 | Not Recruiting | No | | | | 21-12-2020 | 1500 | Observational | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr PunithaVC→ | | Department of Clinical Research, Room No 5, B Block,
No 1 Jawaharlal Nehru Salai
Vadapalani → | drpunitha77@yahoo.co.in→ | 9884052066→ | SRM Institutes for Medical Science→ | Inclusion criteria: Patients testing positive for COVID 19→ | Exclusion criteria: Less than 18 years→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL:<br>→ | Social Demographic Profile and Clinical Outcome in COVID patientsTimepoint: June 29th to Oct 31st 2020→ | | | | Yes | False | | |
| → | CTRI/2020/12/029894 | 27 January 2021 | A study to compare the effectiveness of two drugs, Dexamethasone versus Methylprednisolone in the treatment of moderate Covid 19 patients | Comparing the effectiveness of Dexamethasone versus Methylprednisolone in patients with moderate Covid 19 - A Randomised controlled trial - DMC | | SRM Medical College Hospital and Research Centre | 18-12-2020 | 20201218 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49273 | Not Recruiting | No | | | | 20-12-2020 | 50 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | DR R Nivetha→ | | Department of General Medicine
1st floor
SRM Medical College Hospital and Research centre
SRM University
Potheri
Kattankulathur Department of General Medicine
1st floor
SRM Medical College Hospital and Research centre
SRM University
Potheri
Kattankulathur→ | tavidya@gmail.com→ | 9790911898→ | SRM Medical College Hospital and Research Centre→ | Inclusion criteria: Hospitalized patients with moderate SARS-COV-2 infection laboratory confirmed by RT-PCR <br/ ><br>(Moderate COVID 19- SPO2 <94% Under room air and requiring supplemental oxygen for hypoxemia <br/ ><br>Respiratory rate 24-30/min <br/ ><br>NLR >5 <br/ ><br>CRP 50-100 mg/l <br/ ><br>Serum ferritin 600-1500 ng/ml <br/ ><br>Serum LDH 300-500 IU/l <br/ ><br>D Dimer 0.5-1.0 mic/ml <br/ ><br>IL-6 20-100 pg/ml <br/ ><br>CT chest showing 25-75% infiltrates) <br/ ><br>→ | Exclusion criteria: 1.Patients with mild and severe covid pneumonia <br/ ><br>2.Patients who are already on steroid treatment for any underlying condition <br/ ><br>3.Patients already started on antivirals <br/ ><br>4.Pregnant or lactating women <br/ ><br>5.Any known contraindication to short term corticosteroid like severe immunosuppression, HIV infection or any other immunosuppressant usage <br/ ><br>Â <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Dexamethasone: Inj Dexamethasone 6mg/8mg IV OD X 7 Days<br>Control Intervention1: Methylprednisolone: Inj Methylprednisolone 32mg/60mg IV OD X 6Days<br>→ | Mortality during hospital stayTimepoint: Day 1 - Day 7→ | | | | Yes | False | | |
| → | CTRI/2020/12/029896 | 27 January 2021 | To study Covid disease pattern in health care personnel working in a dedicated Covid Hospital | Clinical Presentation and course of SARS Cov-2 infection in health care personal working in dedicated Covid hospital. | | AIIMS New Delhi | 18-12-2020 | 20201218 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45178 | Not Recruiting | No | | | | 25-12-2020 | 75 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ashish Bindra→ | | Room No. 118,
JPNA Trauma Centre,
All India Institute of Medical Sciences Room No. 710, CN Centre,All India Institute of Medical Sciences, New Delhi→ | dr_ashi2208@yahoo.com→ | 8826417127→ | All India Institute of Medical Sciences, New Delhi, India→ | Inclusion criteria: Health Care Personnel working directly or indirectly in covid areas who were tested covid positive by semi quantitative real-time reverse transcriptaseâ?? polymerase chain reaction or CBNAAT/ TrueNAT platforms on oropharyngeal samples.→ | Exclusion criteria: 1. Non consenting people <br/ ><br>2. Lost to follow up→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B97- Viral agents as the cause of diseases classified elsewhere
→ | | Symptoms and natural course of SARS-CoV-2 Infection in HCPs involved directly and indirectly in patient care in a dedicated covid care center.Timepoint: Baseline <br/ ><br>4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/12/029926 | 27 January 2021 | Cost Burden of Covid-19 in a Tertiary care hospital | Cost of illness and Economic Burden of Covid-19 in a Tertiary care hospital | | Manipal Academy of Higher Education | 18-12-2020 | 20201218 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50574 | Not Recruiting | No | | | | 15-01-2021 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Chaitanyamayee Kalakota→ | | Room no 232, Department of Pharmacy Practice, Manipal college of Pharmaceutical Sciences, Manipal → | mahadev.rao@manipal.edu→ | 8105706060→ | Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education→ | Inclusion criteria: Patients diagnosed with COVID-19 and admitted to respective wards <br/ ><br>Patients above 18 years of Age→ | Exclusion criteria: Medico legal cases <br/ ><br>Incomplete Case Records <br/ ><br>Mortality Cases <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | Economic Burden of Covid-19Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/12/029898 | 27 January 2021 | Self-prone positioning to reduce need of ventilatory support in COVID-19 patients | Self-prone positioning to reduce the need for ventilatory support in COVID-19 patients- a randomized controlled trial | | Dr Upendra Hansda | 18-12-2020 | 20201218 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48811 | Not Recruiting | No | | | | 27-12-2020 | 190 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Upendra Hansda→ | | Room No-4, 5th floor, Hospoital Block, AIIMS Bhubaneswar,
Sijua, Patrapada. Faculty Room, Emergency Department, Dept. of Trauma and Emergency, AIIMS Bhubaneswar→ | uhansdah@gmail.com→ | 9437365720→ | AIIMS Bhubaneswar→ | Inclusion criteria: Suspected (presenting with dyspnea, fever, cough) or confirmed COVID-19 positive having SpO2 â?¥90% with FiO2 â?¤0.6.→ | Exclusion criteria: Patients who are suspected or confirmed COVID-19 and <br/ ><br>a. Not able to follow commands and prone by self <br/ ><br>b. Intestinal obstruction/perforation <br/ ><br>c. Recent abdominal or thoracic surgery <br/ ><br>d. Hemodynamically unstable (SBP <90, HR >120) <br/ ><br>e. Physical habitus not permitting prone position <br/ ><br>f. Pregnancy ( >20 weeks) <br/ ><br>g. Unstable spine or unstable fracture <br/ ><br>h. Respiratory distress with use of accessory respiratory muscles <br/ ><br>i. SpO2 <90% with FiO2 of â?¥0.6 ( <90% with non-rebreather mask and respiratory rate >30) <br/ ><br>j. Patients on ventilator support <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Prone position: All the COVID-19 patients will be treated as per guidelines. The intervention group (group P) will be instructed to lie prone for a session of at least two hours and a total duration of 12 hours in a day. In group NP, the patients will receive only the conventional treatment for COVID-19 (they will be allowed to lie as per their comfort).<br>Control Intervention1: Conventional treatment for COVID-19.: The control group participants will receive the conventional treatment for COVID-19.<br>→ | Requirement of ventilatory supportTimepoint: Day 1, Day 2, Day 3, Day 4, Day 5, Day 6, Day 7, Day 8, Day 9, Day 10.→ | | | | Yes | False | | |
| → | CTRI/2020/12/029902 | 27 January 2021 | A clinical trial of a new product to understand the effectiveness and safety to manage the symptoms of covid positive adult patients.
| A Double Blind, Single Centric, Randomized, Placebo controlled study to demonstrate the efficacy and safety of Omshree Savier/ Omshreeraj (test products) compared to placebo to manage mild to moderate to severe symptoms of covid infections in subjects who are diagnosed as covid positive.
| | Omshree Sidha Hospital | 18-12-2020 | 20201218 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49842 | Not Recruiting | No | | | | 15-01-2021 | 80 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Deepa Subramanian→ | | Syncretic Clinical Research Services Pvt. Ltd.
CEO, 1st Floor,
No. 4, 5th Cross, 11th Main, Vasanthnagar, Bangalore → | info@omshreeayur.com→ | | Omshree Sidha Hospital→ | Inclusion criteria: 1. Adult patients between 18 years and 65 years old, both men or women. <br/ ><br>2. Subject with confirmed mild to moderate to severe COVID-19 in less than 5 days, preferably who has a history of Asthma, Pneumonia, Heart disease or Diabetic and who meets any of the following criteria: <br/ ><br>a. Respiratory distress, RR â?¥ 30 times/min <br/ ><br>b. In resting state, finger oxygen saturation (SpO2) â?¤93% <br/ ><br>c. X-ray of chest showing evidence of pulmonary infiltrates. <br/ ><br>3. The informed consent signed. <br/ ><br>4. Subjects willing to comply with the study Protocol.→ | Exclusion criteria: 1. Creatinine level is less than 1.10. <br/ ><br>2. History of severe liver or kidney diseases. <br/ ><br>3. History of any malignancies. <br/ ><br>4. Subjects who are hypersensitive to herbal medications. <br/ ><br>5. Subjects who are participating in any other trial within 30 days prior to consent. <br/ ><br>6. Pregnant or lactating women. <br/ ><br>7. Any other circumstances that the investigator considers inappropriate for the participation in this study. <br/ ><br>8. Subjects who are unwilling to follow the study plan. <br/ ><br>9. Any condition which subject may have which can cause increase risk of bleeding.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: OMSHREE SAVIER / OMSHREERAJ<br>: 2 capsules 2 times a day and 1 teaspoon granules 4 times a day. <br><br><br>Control Intervention1: Placebo: 2 capsules 2 times a day and 1 teaspoon granules 4 times a day.<br>→ | 1.Time taken to reach Covid-19 negative <br/ ><br>2. Improvement of body temperature from baseline. <br/ ><br>3. Time taken to reach the change in RR from baseline to Day 4 and Day 8. <br/ ><br>4. Change in SpO2 from baseline to Day 4 and Day 8. <br/ ><br>5. Change in chest X-ray from baseline to Day 4 and Day 8. <br/ ><br>6. Time taken for nasal/chest symptoms to become normal from baseline. <br/ ><br>7. Duration of oxygen therapy <br/ ><br>8. Duration of hospitalization <br/ ><br>Timepoint: Screening, Day 0, 4 8 and 21 (in severe cases) <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/12/029900 | 27 January 2021 | A study on stress during work and tiredness in health care workers working in covid units of the university teaching hospital of south India | A survey on work-related stress and burnout in health care providers working in covid units of a university teaching hospital of south India | | Mr Manjuesh U Nayak | 18-12-2020 | 20201218 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50369 | Not Recruiting | No | | | | 01-01-2021 | 147 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ms Pratibha todur→ | | Manipal college of health profession, Department of Respiratory therapy, room no -414, MAHE, Manipal Manipal college of health profession, Department of Respiratory therapy, room no -414, MAHE, Manipal→ | pratibha.todur@manipal.edu→ | 8095103671→ | Manipal college of health profession, MAHE→ | Inclusion criteria: Working in covid units for at-least 6hours/ week within 45 days of time frame→ | Exclusion criteria: Previously diagnosed with psychological issues <br/ ><br>Declined to participate in the study <br/ ><br>Not working the covid units→ | | | Work-related stress and burnout in health care providers <br/ ><br>Timepoint: At 8 week→ | | | | Yes | False | | |
| → | CTRI/2020/12/029901 | 27 January 2021 | Experiences of the Patients and Pharmacists with respect to medicine supply during COVID-19 Pandemic | Impact Of COVID-19 On Medicine Supply Chain: Consumersâ?? And Pharmacistsâ?? Perspective. | | Not Applicable | 18-12-2020 | 20201218 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50383 | Not Recruiting | No | | | | 14-01-2021 | 30 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Manasvini R→ | | Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education, Manipal → | girish.thunga@manipal.edu→ | 9880151127→ | Manipal College of Pharmaceutical Sciences,MAHE,Manipal→ | Inclusion criteria: Inclusion criteria for Pharmacists: Registered pharmacist with appropriate D Pharm or B Pharm degree. <br/ ><br> <br/ ><br>Inclusion criteria for patients: Age above 18 years, both genders, patients with chronic health conditions like diabetes, hypertension and cardiac disorders. <br/ ><br>→ | Exclusion criteria: Exclusion criteria for Pharmacists: Non-qualified personnel working in the pharmacy. <br/ ><br> <br/ ><br>Exclusion criteria for patients: Age below 18 years, those not who are unwilling to provide the consent and with mental illness.→ | Health Condition 1: Z753- Unavailability and inaccessibilityof health-care facilities
→ | | Identification of barriers to the medicine chain supply during COVID-19 from pharmacistsâ?? and consumersâ?? perspective. Themes will be developed which may be useful for coming up with effective strategies to improve the medicine supply chain for such future crises.Timepoint: Interview will be conducted through telephone at single time point.→ | | | | Yes | False | | |
| → | CTRI/2020/12/029897 | 27 January 2021 | Hematological and biochemical markers as poor outcome predictors in COVID-19 | Retrospective study of various hematological and biochemical markers as predictors of outcome in COVID-19 | | Pramukh Swami Medical College | 18-12-2020 | 20201218 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50388 | Not Recruiting | No | | | | 25-12-2020 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India→ | Nirav Thakar→ | | Pramukh Swami Medical College,
Karamsad 388325 Karamsad 388325→ | labanigmg@gmail.com→ | 0269222130→ | Pramukh Swami Medical college→ | Inclusion criteria: All patients admitted in our hospital from March 2020 till date and positive for RAT and RTPCR for COVID-19 will be included irrespective of the outcome→ | Exclusion criteria: Patients less than 18 years of age will be excluded→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B999- Unspecified infectious disease
→ | | This study will help us in understanding the physio-pathology of the disease in a better way. There may <br/ ><br>be a chance that a better triage of patients with bad predictive markers will help us treat and manage them in <br/ ><br>a different way. It will make counseling the patientâ??s relatives regarding the late complications of <br/ ><br>COVID . We may be able to introduce newer dimensions to our <br/ ><br>existing SOPs. In the long run, this will help the institution save lots of money and time.Timepoint: The data will be assessed after every 100 subjects are taken and then once 1000 sample size is reached. probably after 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/12/029957 | 27 January 2021 | To study the effectiveness of pulmonary rehabilitation program in people who have recovered from covid 19 pneumonia and Acute Respiratory Distress | Assessment of Rehabilitation outcome in post acute COVID 19 survivors-A Prospective cohort study | | Department of PMR | 21-12-2020 | 20201221 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48186 | Not Recruiting | No | | | | 22-12-2020 | 217 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Padma Rani S→ | | Outpatient Department number 34,Department of PMR,Government Kilpauk medical college,kilpauk,chennai → | t_arasu2000@hotmail.com→ | 9444367919→ | Government Kilpauk Medical college and Hospital→ | Inclusion criteria: With definitive radio logical evidence of covid pneumonia <br/ ><br>with proved covid 19 positive swab,completed 10 days of admission in isolation ward <br/ ><br>Willing to participate in rehabilitation <br/ ><br>Hemodynamically stable <br/ ><br>Mini-mental state examination (MMSE) score > 21 <br/ ><br>Age between 18 and 80 years→ | Exclusion criteria: 5) Resting Respiratory rate >30/min <br/ ><br>4) SpO2 at rest in room air <85% <br/ ><br>2) Fever, temperature >100â??F <br/ ><br>6) Moderate or severe heart disease (Grade III or IV, NYHA) <br/ ><br>1) Patients who are in acute respiratory distress phase/critical phase , requiring invasive or non invasive ventilation, in covid /suspect ICU/SARI ward→ | Health Condition 1: F- Physical Rehabilitation and Diagnostic Audiology
→ | Intervention1: post acute covid pulmonary rehabilitation: cohort (who underwent categorisation and pulmonary rehabilitation) vs historical control group(who didnt undergo pulmonary rehabilitation) along with respiratory and endurance outcome variables compared at baseline and at 6 weeks post intervention â?¢ Standard operating procedures of Pulmonary rehabilitation based on the classification of the patients into various categories from 0 to 4 based on the factors like Oxygen saturation measured by finger pulse oximetry , respiratory and endurance parameters .For each category defined, the activities to improve the pulmonary status, mobility and ADL as well as an adjuvant to the psychological management isconsidered.<br>â?¢ The scheme of rehabilitation consists of initial Physiatric consultation and evaluation by PMR medical consultant with categorization and description ofexercise,demonstration of exercise by physiotherapist with prior to therapy and post therapy recording of parameters.<br>PMR CONSULTATION<br>â?¢ History taking with respect to present complaints, relevant past history and comorbids, details regarding covid19 swab status, radiological signs of covid pneumonia, date of admission in code word.Assessment of vitals, respiratory parameters- single breath count, breath holding time ,respiratory rate ,Borg scale of dyspnoea at rest and after exertion, Dyspnoeic index ,endurance assessment like 6 minutes walk test / one minute walk test, sit to stand.<br><br>→ | Single breath count <br/ ><br>Breath holding Time, <br/ ><br>Respiratory rate , <br/ ><br>Modified Borg scale of dyspnoea at rest and after exertion, <br/ ><br> Dyspnoeic index <br/ ><br>Timepoint: baseline,1 week,2 weeks,3 weeks post rehabilitation→ | | | | Yes | False | | |
| → | CTRI/2020/12/029956 | 27 January 2021 | Web Based Survey to assess the mental health status of health sciences students during COVID 19 | Mental Health Among Health Sciences Students In India During COVID-19: Web-Based Survey | | NA | 21-12-2020 | 20201221 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50542 | Not Recruiting | No | | | | 14-01-2021 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Siddheesh Rajpurohit→ | | Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE → | kanav.khera@manipal.edu→ | 07889271828→ | Manipal College of Pharmaceutical Sciences, MAHE→ | Inclusion criteria: Open to all Health sciences students pursuing UG, PG or higher degree (AYUSH, Pharmacy, Nursing, Dental, Physiotherapy, MBBS, Life sciences, Lab technicians etc.) <br/ ><br> <br/ ><br>Age range between 19 to 40 years, irrespective of there gender <br/ ><br>→ | Exclusion criteria: General population and Non-health sciences students <br/ ><br>Anyone not willing to participate due to any reason <br/ ><br>→ | | Control Intervention1: NIL: NIL<br>→ | To assess depression, anxiety and stress among health sciences students during COVID-19.Timepoint: 24 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/12/029955 | 27 January 2021 | Effect of the COVID-19 on services offered to pregnant women and their mental health in urban areas of Hyderabad- A study | Effect of the pandemic on maternal health services and mental health of pregnant women in urban areas of Hyderabad- A cross sectional study. | | Prasanna School of Public Health MAHE | 21-12-2020 | 20201221 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48528 | Not Recruiting | No | | | | 01-01-2021 | 300 | Observational | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sudhamshi Beeram→ | | Room number 62, First floor, Prasanna School of Public Health, Madhav Nagar, Manipal, Karnataka, 576104. → | arathi.anil@manipal.edu→ | 08202923111→ | Prasanna School of Pubic Health→ | Inclusion criteria: Women who have been diagnosed as pregnant on or before August 1st, 2020.→ | Exclusion criteria: Postpartum women and women who underwent an abortion are excluded from the study.→ | Health Condition 1: O00-O9A- Pregnancy, childbirth and the puerperium
→ | Intervention1: NIL: NIL<br>→ | To study the effect of the pandemic on maternal health services and mental health of pregnant women.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/12/029954 | 27 January 2021 | Use of soapy nasal irrigation in covid 19 positive cases to reduce viral load in nasopharynx and oropharynx | Use of surfactant- Saline nasal douches in covid 19 positive cases to reduce viable viral load in the nasopharynx and oropharynx,GMERS Medical College and General Hospital,Gotri,Vadodara - SSND | | Dr Nimisha Nimkar Investigator Investigated study | 21-12-2020 | 20201221 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50385 | Not Recruiting | No | | | | 28-12-2020 | 100 | Interventional | Other<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Nimisha Nimkar→ | | GMERS Gotri,Vadodara ENT Department,
GMERS medical college Gotri,
Vadodara
Gujarat→ | urmil4004@yahoo.co.in→ | 9898388061→ | GMERS Medical college,Gotri,Vadodara→ | Inclusion criteria: Pts tested positive for Covid19 and enrolled within 24hrs. <br/ ><br>Pts willing to give consent to participate in study.→ | Exclusion criteria: Pts with k/h/o hypersensitivity to a surfactant. <br/ ><br>Lactating or pregnant mother. <br/ ><br>Pts requiring ICU care as per guidelines and invasive ventilation.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nasal Douching: Surfactant Saline Nasal Douching to be done 3 times in a day for 2 days<br>Control Intervention1: NA: NA<br>→ | Rapid antigen status of Oropharyngeal and Nasopharyngeal swabs on Day 3 in each group.Timepoint: Rapid antigen status of Oropharyngeal and Nasopharyngeal swabs on Day 3 in each group.→ | | | | Yes | False | | |
| → | CTRI/2020/12/029970 | 27 January 2021 | Analysis of COVID 19 features in HRCT Chest of patients who have no evidence of Tuberculosis infection and comparison between COVID and Tuberculosis imaging features in COVID patients. | Analysis of COVID 19 with HRCT Chest in IGRA negative patients- A study in a COVID Hospital of Odisha | | KIMS Hospital | 22-12-2020 | 20201222 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46461 | Not Recruiting | No | | | | 01-01-2021 | 50 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sudhansu Sekhar Mohanty→ | | Department of Radiodiagnosis, kalinga institute of Medical Sciences, Patia, Bhubaneswar → | sudhansumohanty2009@gmail.com→ | 9994663960→ | Kalinga institute of medical sciences→ | Inclusion criteria: 1.COVID 19 positive patients with imaging features suggestive of exposure to M. Tuberculosis. <br/ ><br>2.Those COVID positive patients who have undergone both HRCT and IGRA. <br/ ><br>→ | Exclusion criteria: COVID 19 negative patients <br/ ><br>Absence of any evidence of TB on imaging <br/ ><br>Those who have not undergone IGRA <br/ ><br>Those who have refused IV contrast study when indicated.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | The cases were evaluated by a panel of skilled radiologists for identifying the imaging characteristics to develop a generalised protocol to differentiate COVID-19 from TB in Indian populationTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2020/12/029982 | 27 January 2021 | â??Experiences and readiness of the volunteers during the COVID-19 in Bengaluruâ?? | â??Experiences and preparedness of the volunteers during the COVID-19 Pandemic in Bengaluru- A Qualitative study.â?? | | Prasanna School of Public Health MAHE | 23-12-2020 | 20201223 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50712 | Not Recruiting | No | | | | 12-01-2021 | 30 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Zeenath Roohi→ | | Room number 62, First floor, Prasanna School of Public Health, Madhav Nagar, Manipal, Karnataka, 576104. → | kumar.sumit@manipal.edu→ | 9964331671→ | Prasanna School of Pubic Health→ | Inclusion criteria: Should have volunteered during the COVID-19 Pandemic <br/ ><br> <br/ ><br>Should have volunteered for a minimum period of 2 weeks <br/ ><br> <br/ ><br>Specific to those who volunteered with mercy mission in any of their project verticals during the COVID-19 Pandemic <br/ ><br>→ | Exclusion criteria: A salaried employee of the organization→ | | Intervention1: NIL: NIL<br>→ | Understanding the experience of volunteers which will provide evidence-based information for further Standard operative procedures (SOP) in future for the organization.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2020/12/029983 | 27 January 2021 | This study will help us in understanding how this disease progresses and why some became sicker. This study may also help in the development of novel therapy. | Characterization of the proteolytic processes in the serum of patients with Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) pneumonia- a pilot study
| | National Institute of malaria Research New Delhi | 23-12-2020 | 20201223 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49190 | Not Recruiting | No | | | | 24-12-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Sajal De→ | | Room No 104
Dept of Pulmonary Medicine
All India Institute of Medical Sciences
G E Road
Tatibandh
Raipur AIIMS, Raipur→ | sajalde@yahoo.com→ | 09406573825→ | AIIMS, Raipur→ | Inclusion criteria: Adult of both sexes sufferings or recovered from covid 19 pneumonia will be recruited→ | Exclusion criteria: Patients with pre-existing respiratory diseases i.e. active pulmonary tuberculosis, bronchial asthma, and chronic obstructive pulmonary disease will be excluded from the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: None: None<br>→ | â?¢ Differential protease expression in patients with SARS-CoV-2 infection who required supplemental oxygen/invasive/non-invasive ventilation vs healthy individuals and mild COVID patients who didnâ??t require supplemental oxygen. <br/ ><br> <br/ ><br>â?¢ Identification of unusual proteases and their inhibitors. <br/ ><br> <br/ ><br>â?¢ Identification and database preparation of target proteins involved in the pathogenesis of SARS-CoV-2 disease. <br/ ><br> <br/ ><br>Timepoint: At base line→ | | | | Yes | False | | |
| → | CTRI/2020/12/029985 | 27 January 2021 | An Open labeled study in efficacy of add-on Ayurveda intervention in comparison with standard in Covid-19 patients with moderate severity and with type 2 diabetes followed by 60 day follwo-up | An Open-labeled study to investigate efficacy of add-on personalized Ayurveda intervention in Covid-19 Patients with moderate diseases severity with type 2 diabetes followed by 60 day follow-up of post-viral syndrome post Covid-19 in comparison to standalone treatment based on ICMR guidelines - AAIC | | AVP Research Foundation | 23-12-2020 | 20201223 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50354 | Not Recruiting | No | | | | 28-12-2020 | 100 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Sujith Eranezhath→ | | 136/137, Head, Basic & Translational Research, AVP Research Foundation, Ramanathapuram PO → | cso@avpresearch.org→ | | AVP Research Foundation→ | Inclusion criteria: (i) Confirmed case of COVID with RT-PCR method not requiring ventilator or Intensive Care Unit support at the time of induction (ii) Aged above 18 years and less than equal to 70 years willing to give informed consent. (iii) Patients with Diabetes Mellitus Type II as co-morbidity (v) Arterial SpO2 in Room air less than or equal to 95 % or more than or equal to 90% at baseline (vi) NLR more than or equal to 3 (vii) IL6 not less than 25 (viii) CT score not less than 25% and not more than 50% of Lung consolidation (CORAD Score equivalent to the same) (ix) Patients on both Remdisivir and steroids→ | Exclusion criteria: Co-morbidities like acute and advanced stage of chronic obstructive pulmonary disease, malignancy, chronic liver diseases, recent history of cardiovascular events, renal diseases, HIV patients, Pregnant and Lactating women, acute inflammatory complications of diabetes like non-healing ulcers /severe neuropathy, Patient requiring ventilator support as decided by medical team, Type I Diabetes Mellitus, History of CVA or Stroke. Covid-19 induced hyperglycemia, any subject having any affiliation to the participating institutions will be excluded.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Add-on personalised Ayurveda intervention to ICMR Guideline on Covid-19: Internal Medication: <br>Panchathikthakam Kashayam - (Ref: Bhaishajya Ratnavali Jwara adhikara 113 sloka).<br>Ashtanga Lehyam- .(Ref: Chakra datta jwara chikitsa 162 -163 ) <br>Nasyam â?? Matulunga (Citrus medica), Ardraka (Zingiber officinale) Swarasa + Tri Lavana â?? (Ref: Chakradatta sannipattika jwara chikitsa sloka 157-158) <br>Indukantham Kashayam - (Ref: Sahasrayogam/Ghritaprakaranam).<br>Drakshadi Kashayam - (Ref: Ashtangahridyam, Chikitsa Sthana, Jwara chikitsa 55-58 shloka).<br>Guduchyadi Kashayam - (Ref: Ashtangahridyam, Sutrasthana, Shodhanadiganasangraha 16 shloka).<br>Vilwadi Gulika - (Ref: Ashtangahrudayam, Uttarasthana Sarpavishapratishedha 84-85 shloka).<br>Patolkadurohinyadi Kashyam â?? (Ref: Ashtanga Hridayam Sutra Sthana, Shodanadigana sangraha 15 shloka).<br>Brihat Bharangyadi kashyam- (Ref: Sahasrayoga Kashaya prakarana).<br>Pravala bhasmam mixed along with Honey or Betel leaf juice or Tulasi juice<br>Swasanandam pill - Ref: Ashtangahridayam<br>Gorochanadi pill - (Ref: Vaidyaraj Rathnavali)<br>Suvarnamuktadi pillâ?? (Ref:Ashtangahridayam)<br>Brahma Rasayana - (Ref: Ashtangahridayam Uttar Asthana Rasayanavidhi 15-23 shloka.<br>Agasthya rasayanam - Ref: Ashtangahridayam Chikitsasthana Kasachikitsa 127-132 shloka. <br>Dhanwantharam Ghrita - Ref: Ashtangahridayam <br>Indukantham Ghritham - Ref: Ashtangahridayam Sutrsthanam Shodhanadigana sangaraha 9-10 shloka)<br>Baladi Ghritham â?? (Ref: Bhaisajya ratnavali Rajayakshma page 254, sloka 133-136)<br><br>Control Intervention1: Treatment based on ICMR Guideline on Covid-19 without any add on.: ICMR Guidelines for Covid-19 would adhered to for the treatment<br>→ | 1. Improve the response of the patient through integrative therapy <br/ ><br>2. Changes in inflammatory markers IL6, CRP <br/ ><br>3. Modulation of NLR ratio. <br/ ><br>4. Long term effect of Integrative therapy on lung, cardiac, liver and renal functions and neuropsychological symptoms. <br/ ><br> <br/ ><br>Timepoint: Timeline <br/ ><br>Day 0 <br/ ><br>Day 7 <br/ ><br>Day 11 <br/ ><br>Day 14 <br/ ><br>Day 28 <br/ ><br>Day 60 <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/12/029984 | 27 January 2021 | STUDY OF CORRELATION BETWEEN MARKERS OF COAGULATION AND CLINICAL SEVERITY IN COVID 19 | A STUDY OF COAGULATION MARKERS AND THEIR CORRELATION WITH CLINICAL SEVERITY IN COVID 19 ILNESS | | Smt NHL Municipal Medical College | 23-12-2020 | 20201223 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49872 | Not Recruiting | No | | | | 28-12-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DR PALTIAL PALAT→ | | Department of medicine, first floor, Sardar Vallabhbhai Patel Institute
of Medical Science and Research (SVPIMSR), Ellisbridge,
Ahmedabad,
Gujarat-380006 → | akash.jani@gmail.com→ | 8460706921→ | Smt NHL Municipal Medical College→ | Inclusion criteria: Inpatients in General Medicine with a established diagnosis of COVID 19 infection( Laboratory confirmed ) <br/ ><br>Patients with abnormal coagulation markers Patients of age >18 years <br/ ><br>→ | Exclusion criteria: Patients with proven others causes of coagulopathy - VTE, DVT, Recent Surgery/Trauma, Pregnancy, Cancer <br/ ><br>Patients already on anticoagulant therapy <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | In-hospital stay (Duration and Type of stay: ICU or Ward) <br/ ><br>Timepoint: At Baseline, Every 3rd Day till Discharge/Death→ | | | | Yes | False | | |
| → | CTRI/2020/12/029981 | 27 January 2021 | Study to look for cardiovascular manifestations of COVID | To study cardiovascular involvement in COVID 19 patients | | Rohit Walia | 23-12-2020 | 20201223 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50659 | Not Recruiting | No | | | | 28-12-2020 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rohit Walia→ | | Room No. 25103 , Department of cardiology , All India Institute of Medical Science , Virbhadra Road , Pashulok , Rishikesh . → | rwalia7731@yahoo.in→ | 8800492549→ | All India Institute of Medical Science Rishikesh→ | Inclusion criteria: Patients with COVID 19 disease confirmed by RTPCR <br/ ><br>Age greater than 18 years→ | Exclusion criteria: Not giving informed consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | Incidence of acute myocardial events in COVID-19 population at baseline <br/ ><br>and during hospital stayTimepoint: Incidence of acute myocardial events in COVID-19 population at baseline <br/ ><br>and during hospital stay→ | | | | Yes | False | | |
| → | CTRI/2020/12/030015 | 27 January 2021 | High Flow Nasal Oxygen Therapy in COVID-19 patients | High Flow Nasal Oxygen Therapy in COVID-19 patients : A cross-sectional study | | All India Institute of Medical Sciences Jodhpur | 24-12-2020 | 20201224 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50436 | Not Recruiting | No | | | | 28-12-2020 | 108 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Samarth Agarwal→ | | Department of Anaesthesiology and Critical Care, AIIMS Hospital, Basni Phase 2, Jodhpur, Rajasthan → | samarthx@gmail.com→ | 8932938707→ | All India Institute of Medical Sciences, Jodhpur→ | Inclusion criteria: - Patients tested COVID-19 positive by Reverse Transcriptase Polymerase Chain Reaction (rt-PCR) test and admitted in Corona Critical Care wards at AIIMS, Jodhpur till January 31, 2021 <br/ ><br>- Requiring the use of High FLow Nasal Oxygen Therapy→ | Exclusion criteria: - Patients who / whose proxies refuse to consent to use of their data for research <br/ ><br>- Patients who were on non-invasive / invasive mechanical ventilation before the use of HFNC (High Flow Nasal Cannula)→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | The number of patients who did not require intubation and invasive mechanical ventilation by using HFNC as a rescue modality to manage hypoxemia in rt-PCR confirmed Covid-19 patients admitted to the critical care settingTimepoint: At the time of initiating HFNC and daily at 24hrs intervals after till a positive / negative outcome is reached→ | | | | Yes | False | | |
| → | CTRI/2020/12/030014 | 27 January 2021 | Study of mental status(anxiety and depression) in pregnant women during COVID-19 pandemic | Screening of prenatal depression and anxiety among pregnant women during COVID-19 pandemic | | Ayesha Siddiqua | 24-12-2020 | 20201224 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50457 | Not Recruiting | No | | | | 25-12-2020 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India→ | Ayesha Siddiqua→ | | Department of OBG, KMC Manipal, Udupi, Karnataka → | vidyashree.g@manipal.edu→ | 9901731619→ | Kasturba Medical College, Manipal→ | Inclusion criteria: Women with singleton pregnancies of all trimesters of any age are included→ | Exclusion criteria: Women with non viable pregnancy, fetal anomaly, suspected or confirmed covid-19→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: O993- Mental disorders and diseases of the nervous system complicating pregnancy, childbirth and the puerperium
Health Condition 3: O998- Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium
→ | Intervention1: nil: nil<br>Control Intervention1: nil: nil<br>→ | 1)Proportion of prenatal depression and their severity among pregnant women in each trimester. <br/ ><br>2)Proportion of prenatal anxiety and their severity among pregnant women in each trimester <br/ ><br>3)Severity of psychological impact of covid-19 pandemic on antenatal womenTimepoint: 1 week→ | | | | Yes | False | | |
| → | CTRI/2020/12/030013 | 27 January 2021 | A clinical study to evaluate the efficacy and safety of Sofosbuvir/Daclatasvir (tablet) with or without Nitazoxanide when given with the standard of care in Moderate COVID-19 Patients. | Phase IIb Study to Evaluate the Efficacy and Safety of Sofosbuvir/Daclatasvir (Sof/Dcv) With or Without Nitazoxanide In Combination with Standard of Care in Adult Patients with Moderate Covid-19 | | Mylan Laboratories Limited | 24-12-2020 | 20201224 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50222 | Not Recruiting | No | | | | 25-12-2020 | 366 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Shariq Anwar→ | | Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4 ,
Sector 27 D, Delhi Mathura Road, Near Sarai Khwaja Metro Station, Faridabad -121003, Haryana, India → | sonika.newar@jssresearch.com→ | 08698065660→ | JSS Medical Research India Pvt. Ltd.→ | Inclusion criteria: 1.Male or female, age â?¥ 18 to â?¤ 65 years <br/ ><br>2.Subject (or legally authorized representative) provides informed consent prior to initiation and comply with planned study procedures. <br/ ><br>3.Has laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) <br/ ><br>4.Illness of Moderate severity <br/ ><br>→ | Exclusion criteria: 1.Patients with clinical signs of pneumonia plus signs of severe Covid. <br/ ><br>2.Requiring mechanical ventilation or ECMO at screening <br/ ><br>3.Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving hemodialysis or hemofiltration). <br/ ><br>4.Cardiac failure NYHA Class III, IV and V. <br/ ><br>5.Pregnancy or breast feeding. <br/ ><br>6.Evidence of multiorgan failure <br/ ><br>7.Any malignancy or cerebro-vascular complications <br/ ><br>8.Any other condition as per the physicianâ??s discretion which would make the patient unsuitable for enrollment in the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Daclatasvir and Sofosbuvir Film Coated Tablets 60/400mg Fixed Dose Combination: Arm 1- MyHep DVIRTM; (Daclatasvir and Sofosbuvir Film Coated Tablets 60/400mg Fixed Dose Combination) once daily for 14 days + SOC. <br><br><br>Intervention2: Daclatasvir and Sofosbuvir Film Coated Tablets 60/400mg Fixed Dose Combination: Arm 2 - MyHep DVIRTM; (Daclatasvir and Sofosbuvir Film Coated Tablets 60/400mg Fixed Dose Combination)+ 500 mg of Nitazoxanide twice daily for 14 days in addition to SOC<br><br>Intervention3: Daclatasvir and Sofosbuvir Film Coated Tablets 60/400mg Fixed Dose Combination: Arm 3- Standard of Care (SOC)<br>Intervention4: Daclatasvir and Sofosbuvir Film Coated Tablets 60/400mg Fixed Dose Combination: Arm 3- Standard of Care (SOC)<br>→ | 1.SARS CoV-2 Viral Negativity Rate <br/ ><br>2.Time to Clinical ImprovementTimepoint: 1.At day 7 <br/ ><br>2.At day 15→ | | | | Yes | False | | |
| → | CTRI/2020/12/030046 | 27 January 2021 | safety of remdesivir use in patients with impaired kidney function and covid 19 infection | safety of Remdesivir use in patients with acute or chronic kidney disease and covid 19 infection | | DrMaulin Shah | 28-12-2020 | 20201228 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50693 | Not Recruiting | No | | | | 31-12-2020 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Investigator Blinded | N/A | India→ | DrMaulin Shah→ | | Privilege center,The Healing Tree,Shree Krishna Hospital,H M Patel centre for medical care and education,Karamsad,Anand Dialysis centre,Privilege economy ward,Shree krishna hospital,H M Patel centre for medical care and education,Karamsad,Anand→ | mauls39@gmail.com→ | 9904163277→ | Pramukhswami medical college,H M Patel centre for medical care and education→ | Inclusion criteria: All covid positive (Rapid antigen test or RT PCR) patients admitted in shree Krishna hospital from March 2020 whose presenting creatinine is more than 1.4 mg/dl in Male or 1.2 mg/dl in Female or who are having oliguria /anuria (urine output less than 0.5 ml/kg/hour in first 24 hours -as per Standard KDIGO criteria) and who also received Remdesivir short or prolonged course during hospital stay will be included.→ | Exclusion criteria: Those Covid positive patients with renal dysfunction will be excluded from study if they do not complete the course of remdesevir suggested by clinician. <br/ ><br>However, those patients who expired during treatment of remdesivir will be included in study and they will be analyzed separately. <br/ ><br>→ | Health Condition 1: N179- Acute kidney failure, unspecified
Health Condition 2: N189- Chronic kidney disease, unspecified
Health Condition 3: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Remdesevir is safe in patients with acute or chronic kidney injury and covid 19 infectionTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/12/030049 | 27 January 2021 | A RETROSPECTIVE OBSERVATIONAL STUDY IN COVID-19 PATIENTS ADMITTED TO THE ICU TO SEE WHETHER DERANGEMENT OF VARIOUS BIOMARKERS IN PATIENT BLOOD TESTS CORRELATE WITH THE OUTCOME OF THEIR ILLNESS. | CORRELATION OF PATIENTS PROFILE AND BIOMARKERS WITH
OUTCOMES IN COVID-19 ICU PATIENTS: A RETROSPECTIVE ANALYSIS | | Maulana Azad Medical college | 28-12-2020 | 20201228 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50718 | Not Recruiting | No | | | | 02-01-2021 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Karthik K Raman→ | | C/O Dr. Amit Kohli, Department of Anesthesiology and Intensive care, 3rd floor, BL Taneja Block, Maulana Azad Medical college, Bahadur Shah Zafar Marg, New Delhi
→ | dramitkohli@yahoo.com→ | 9818073402→ | Maulana Azad Medical college→ | Inclusion criteria: ALL PATIENTS WITH LABORATORY CONFIRMED COVID19 ADMITTED TO THE INTENSIVE CARE UNIT UNDER OUR OBSERVATION DURING THE STUDY PERIOD→ | Exclusion criteria: THERE ARE NO EXCLUSION CRITERIA FOR THIS OBSERVATIONAL STUDY→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | SURVIVAL OF PATIENTSTimepoint: BASELINE DATA COLLECTED AT TIME OF ADMISSION TO THE ICU <br/ ><br> <br/ ><br>COURSE OF ILLNESS AND OUTCOME NOTED AT THE TIME OF DISCHARGE FROM THE ICU (RECOVERY) OR DEATH→ | | | | Yes | False | | |
| → | CTRI/2020/12/030050 | 27 January 2021 | An observational study to observe the effect of SARS COVID 19 infection on mother and fetus. | Maternal and perinatal outcome of pregnant women with SARS COVID 19 infection | | Lady Hardinge Medical College New Delhi Smt Sucheta Kriplani Hospital | 28-12-2020 | 20201228 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50778 | Not Recruiting | No | | | | 04-01-2021 | 220 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Kiran Aggarwal→ | | L-12 Prasad Nagar
Karol Bagh
New Delhi Department of Obstetrics and Gynaecology
Lady Hardinge Medical College New Delhi 110001→ | dr_kiranaggarwal@hotmail.com→ | 9312277346→ | Lady Hardinge Medical College→ | Inclusion criteria: â?¢ All patients admitted to the hospital as COVID 19 infection suspects with pregnancy admitted to the department of Obstetrics and Gynaecology of Smt Sucheta Kriplani Hospital, New Delhi will be included in the study.→ | Exclusion criteria: → | Health Condition 1: B338- Other specified viral diseases
Health Condition 2: O099- Supervision of high risk pregnancy, unspecified
→ | | In COVID positive pregnant women <br/ ><br>Maternal near miss rate and maternal mortality rate <br/ ><br>Timepoint: In COVID positive pregnant women <br/ ><br>Maternal near miss rate and maternal mortality rate <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/12/030044 | 27 January 2021 | Questionnaire survey for analyzing the students concept on online learning during the COVID 19 pandemic | Survey on allied health students perception on synchronous online training during COVID 19 pandemic | | NIL | 28-12-2020 | 20201228 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50524 | Not Recruiting | No | | | | 28-12-2020 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Mr TOMIN J THACHIL→ | | DEPARTMENT OF RESPIRATORY THERAPY
FOURTH FLOOR
MANIPAL COLLEGE OF HEALTH PROFESSIONS (MCHP)
MAHE
MANIPAL
UDUPI
576104
KARNATAKA → | pratibha.todur@manipal.edu→ | 8095103671→ | MANIPAL COLLEGE OF HEALTH PROFESSIONS→ | Inclusion criteria: Health care students undergoing synchronize academic training via online platforms.→ | Exclusion criteria: 1. Postgraduate students <br/ ><br>2. Students from the department study are being conducted â?? To avoid allocation bias.→ | | Intervention1: Online Survey: Questionnaire will be distributed among students through Email and Whatsapp.<br>The study will be done in two months and about 300 students will be given the questionnaire.<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | 1. Ease and comfort of online learning among health care students obtained in percentage. <br/ ><br>2. Suitability of environment associated with online learning obtained in percentage. <br/ ><br>3. Internet connectivity with online learning obtained in percentage. <br/ ><br>4. Future preferences of online learning among health care students obtained in percentage.Timepoint: 8 MONTHS→ | | | | Yes | False | | |
| → | CTRI/2020/12/030072 | 27 January 2021 | Investigator Initiated Study To Evaluate Leflunomide for the Treatment of Corona Virus Disease 2019 (COVID-19) | Targeting de novo Pyrimidine Biosynthesis by leflunomide as a Novel Concept for the Treatment of Corona Virus Disease 2019 (COVID-19) - DEFEAT-COVID | | Research and Development Department RD | 28-12-2020 | 20201228 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50013 | Not Recruiting | No | | | | 30-12-2020 | 178 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | United Kingdom;India→ | Dr Deven Juneja→ | | Department Of Critical Care
Press Enclave Marg
Saket District Centre
Saket
New Delhi
Delhi → | devenjuneja@gmail.com→ | | Max Smart super specialty Hospital→ | Inclusion criteria: Age â?¥18 years <br/ ><br>2. Patients with onset of symptoms ï?£15 days <br/ ><br>3. Laboratory (RT-PCR) confirmed infection with 2019-nCoV.→ | Exclusion criteria: Exclusion criteria: <br/ ><br>1. Pregnant or breast feeding; <br/ ><br>2. On specific monoclonal antibodies, or other drug trial treatment for COVID-19 within one week prior to study enrolment; <br/ ><br>3. Liver function tests >2 fold of upper limits of normal (ULN) reference levels of the respective testing assay. <br/ ><br>4. Patients with known hypersensitive to leflunomide <br/ ><br>5. Patients with severe immunodeficiency syndrome and hypoalbuminaemia.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Leflunomide tablet and Standard Of Care: loading dose of oral Leflunomide 100mg daily for 3 days, followed by leflunomide 10-20mg daily, to maintain a total course of 10 days.<br>Control Intervention1: Standard Of Care: to be given for 10 days as per hospital policies<br>→ | 1.Time to Clinical Improvement (TTCI, censored at Day 28; time frame: up to 28 days) <br/ ><br>TTCI is defined as the time (in days) from initiation of study treatment (active or placebo) until a decline of two categories from status at randomisation on a 7 category ordinal scale of clinical status which ranges <br/ ><br>from 1 (discharged) to 7 (death) as per WHO R&D Blueprint expert group. The 7-category ordinal scale <br/ ><br>Timepoint: Day 1- Day 28→ | | | | Yes | False | | |
| → | CTRI/2020/12/030048 | 27 January 2021 | Role of imaging in the diagnosis of extrapulmonary manifestations of COVID 19 | Role of imaging in the diagnosis of extrapulmonary manifestations of COVID 19 | | Lokesh M | 28-12-2020 | 20201228 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50284 | Not Recruiting | No | | | | 01-01-2021 | 50 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Lokesh M→ | | Department of Radiology
Sri Ramachandra institute of higher education and research
No 1 Ramachandra Nagar
Porur Chennai 600116
Tamilnadu → | rrajeswaran2000@gmail.com→ | 9841311552→ | Sri Ramachandra Institute of higher education and research→ | Inclusion criteria: (i) Positive nasopharyngeal or lower respiratory tract reverse transcriptase-polymerase chain reaction assays; <br/ ><br>(ii) Neurologic/ abdominal/ vascular manifestations <br/ ><br>(iii) Abnormal CT/ MRI brain, USG/CT abdomen, USG doppler / CT Angiogram / venogram. <br/ ><br>→ | Exclusion criteria: (i) Negative test for COVID <br/ ><br>(ii) Chronic lesions not related to COVID <br/ ><br>(iii) Ischemic lesions/ infarcts not attributable to COVID <br/ ><br>(iv) Where follow up could not be done <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | Clinical recovery of the patientTimepoint: At baseline at 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/12/030053 | 27 January 2021 | Blood Investigations in Covid 19 patients | Utility of routine clinical laboratory tests for diagnosis and management of COVID 19 - CLTCOVID | | Bhabha Atomic research Centre Hospital | 28-12-2020 | 20201228 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50813 | Not Recruiting | No | | | | 23-01-2021 | 5000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Prachi R Gaddam→ | | Room No 3, First Floor, Department of pathology, Bhabha Atomic research Centre Hospital, Anushaktinagar, Mumbai → | doctina77@gmail.com→ | 022-25598353→ | Bhabha Atomic Research Centre Hospital→ | Inclusion criteria: COVID 19 suspect patients who presented to Fever clinic at BARCH hospital and were tested for routine blood parameters at department of Pathology, BARC Hospital.→ | Exclusion criteria: Incomplete records <br/ ><br>Patients who were ordered swab test for COVID 19 but not routine investigations→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | a. To analyze routine clinical laboratory tests in COVID19 suspect patients and compare the values among RT-PCR positive and negative groups. <br/ ><br>c. To determine the correlation between clinical laboratory data and the outcome of COVIDâ??19 in adult patients.Timepoint: COVID 19 suspect patients registered under CHSS (Contributory health service scheme) who presented to Fever clinic at BARCH hospital and were tested for RT-PCR and/ or RAT from April 2020 till November 2020→ | | | | Yes | False | | |
| → | CTRI/2020/12/030070 | 27 January 2021 | Inflammatory markers and other biochemical parameters in COVID -19 and their association with mortality outcome in Diabetes verses Non Diabetes patients of coastal karnataka tertiary care hospital. | A Comparative study of Inflammatory markers and biochemical parameters among Diabetic and Non Diabetic patients with COVID â?? 19 and their influence on the disease outcome in tertiary care hospital of coastal Karnataka | | Dr Shaheen B shaikh | 28-12-2020 | 20201228 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50147 | Not Recruiting | No | | | | 01-02-2021 | 2000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Shaheen B Shaikh→ | | Department of Biochemistry Yenepoya Medical college University Road Deralakatte Mangalore 575018 karnataka India → | drshaheenshaikh@yenepoya.edu.in→ | 9663165942→ | Yenepoya Medical College→ | Inclusion criteria: All the Covid 19 diagnosed (18 -70 years ) and admitted patients at yenepoya Medical college hospital. All patients were diagnosed based on the WHO recommendations for cases who have a positive RT - PCR test for SARS-CoV-2. The diabetic group included all patients with Diabetes on insulin and/or oral hypoglycemic agents . The non-diabetic group included all the other patients with no history of taking antidiabetic medication and who had normal random blood glucose and HbA1c on admission <br/ ><br> <br/ ><br>→ | Exclusion criteria: Patients who had no laboratory investigations will be excluded pregnant females were excluded from the study <br/ ><br> <br/ ><br>→ | Health Condition 1: J069- Acute upper respiratory infection,unspecified
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | 1. Evaluate and compare the Inflammatory markers in Diabetic and Non Diabetic patients with COVID â?? 19 in tertiary hospital of coastal Karnataka.Timepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/12/030052 | 27 January 2021 | RESEARCH STUDY ON COVID19 ANTIBODIES IN HEALTH CARE WORKERS AT TERTIARY CARE HOSPITAL | COVID19 SEROLOGY IN HEALTH CARE WORKERS AT TERTIARY CARE CENTRE | | SRM | 28-12-2020 | 20201228 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50149 | Not Recruiting | No | | | | 20-01-2021 | 120 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Bhuvanamha Devi Ramamurthy→ | | Department of Pathology
SRM MCH and RC
SRM institute of Science and Technology
Kattankulathur → | drrbdevipath@gmail.com→ | 8148840658→ | SRM institute of Science and Technology→ | Inclusion criteria: All Health care workers working in SRM MCH & RC, Potheri <br/ ><br>In Covid 19 â?? ICU Wards and OP clinic <br/ ><br>In non-COVID 19 ICU Wards and OP Clinics <br/ ><br>Without daily patient contact <br/ ><br>Healthy individuals as Controls <br/ ><br>→ | Exclusion criteria: Individuals with typical symptoms of COVID 19 <br/ ><br>Individuals not giving Consent for the study <br/ ><br>→ | | | To evaluate the sero-prevalence of IgG Sar-CoV2 in Health care workers who are exposed to COVID-19 patients, in SRM MCH&RC, Tertiary care Hospital.Timepoint: 4 to 8weeks→ | | | | Yes | False | | |
| → | CTRI/2020/12/030051 | 27 January 2021 | ImmunoModulatory Efficacy of Nichi Glucan in Covid19 Patients. | An Open Label, Prospective, Randomised, Comparative, Two Arm Clinical Study to Evaluate the Immunomodulatory Efficacy of Nichi Glucan in comparison with Conventional Therapeutic Regimen in Adult Subjects with Covid 19 caused by SARS-CoV2 (B-CoV). | | Medi Nippon Health Care Private Limited | 28-12-2020 | 20201228 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48880 | Not Recruiting | No | | | | 05-01-2021 | 48 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Dr R Senthilkumar→ | | No.6, Zakariah Colony III St., Choolaimedu Chennai 600 094 → | mail@medinippon.jp→ | 9444083550→ | Medi Nippon Health Care Private Limited→ | Inclusion criteria: 1. Adult subjects between 18 and 65 years (both ages and sexes inclusive) who are confirmed to be positive for SARS-CoV2 by way of RT-PCR in a laboratory approved by MoH-FW and the State Government. <br/ ><br>2. Subjects with co-morbidities can be included. To be analysed as cohort. <br/ ><br>3. Subjects who are found to be Covid19 positive requiring hospitalization. (symptomatic or asymptomatic) <br/ ><br>4. Subject and LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period. <br/ ><br>5. Subjects who are willing not to participate in any other clinical trial during participation in the current trial. <br/ ><br>→ | Exclusion criteria: 1. Subjects who have previously been infected with SARS-CoV2 (symptomatic or asymptomatic) and recovered. <br/ ><br>2. Subjects who are known to be HIV, HBV, HCV positive. <br/ ><br>3. Subjects who have clinically abnormal renal or hepatic function values that are 3x times normal upper limit or in the opinion of the Investigator would impact the objectives of the study. <br/ ><br>4. Subjects with complete cancer remission less than 3 years prior to the date of screening. <br/ ><br>5. Subjects who have undergone major surgical procedure 4 weeks prior to randomisation. <br/ ><br>6. Subjects who are on anti-depressants, anti-psychotics. <br/ ><br>7. Subjects with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; except those that are considered etiology of said indication. <br/ ><br>8. Females who are pregnant or nursing or planning to become pregnant during the study period. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nichi Glucan: Nichi Glucan is provided along with Conventional Therapy<br> <br>Dose : 0.5 g x 6 sachets per day â?? 3 gm; 2 sachets to be taken 30 minutes after a meal thrice daily<br><br>Duration : 30 Days<br><br>Route of Administration : Oral<br>Control Intervention1: None. Only Conventional Therapy to be provided.: None. Only Conventional Therapy to be provided.<br>→ | 1. Covid19 Clinical Symptoms: Time taken for improvement, complete recovery, recurrence in typical symptoms not limited to pyrexia, respiratory distress, cephalgia, malaise from baseline. <br/ ><br>2. RT PCR: Time taken for negative RT PCR Result from baseline. <br/ ><br>3. RT PCR : Reduction of titer/severity level from baseline.Timepoint: Covid19 Clinical Symptoms: Day 1, Day 15, Day 30 <br/ ><br>RT PCR: Day 1, Day 15, Day 30→ | | | | Yes | False | | |
| → | CTRI/2020/12/030083 | 27 January 2021 | To Study the Role of Vitamin D in the Treatment of Confirmed COVID-19 Infection | To Study the Role of Vitamin D in the Treatment of Confirmed COVID-19 Infections | | Pulse Pharmaceuticals Pvt Ltd | 29-12-2020 | 20201229 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46899 | Not Recruiting | No | | | | 31-12-2020 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Dr Shyam Sundar Varaprasad Raju→ | | Gandhi Medical College and Hospital Musheerabad Padmarao Nagar Secunderabad
→ | drgsgmbbs@gmail.com→ | 9848152349→ | Gandhi Medical College & Gandhi Hospital→ | Inclusion criteria: 1. Patients aged above 18 years either gender with positive RT-PCR for novel Corona Virus causing Covid-19 pandemic. <br/ ><br>2.Only patients categorized as suffering from uncomplicated illness (category 1), mild pneumonia (category 2) and severe pneumonia (category 3) as defined by ICMR dt. 31-03-2020, will be selected to participate in the study. <br/ ><br>3.Women of childbearing potential must agree to use contraception for the duration of the study. <br/ ><br>4.Patients or their legally acceptable representative willing to sign the informed Consent form.→ | Exclusion criteria: 1. Patients less than 18 years of age. <br/ ><br>2. Patience who have taken high dose vitamin D (i.e.60,000 IU of Vitamin D) In the last 3months either daily, Weekly or monthly or whose 25 (OH) D level is above 30 ng/ml. <br/ ><br>3. Refusal to participate expressed by patient or legally authorised representative if they are present. Refusal to sign the informed Consent form. <br/ ><br>4. Patients of category 4, 5, 6 ( ARDS, Sepsis, Septic Shock) Respectively as a defined by ICMR. <br/ ><br>5. Patients suffering from active malignancy. <br/ ><br>6. Severe chronic kidney disease or requiring dialysis ( i.e. eGFR <30 mL/min). <br/ ><br>7. Pregnancy and breast-feeding. <br/ ><br>8. Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ ><br>9. Contraindication to any study medication including allergy. <br/ ><br>10. Human immunodeficiency virus infection under highly active antiretroviral therapy ( HAART). <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: O- Medical and Surgical
Health Condition 3: B338- Other specified viral diseases
→ | Intervention1: DEKSEL Nano Syrup: 1. Uncomplicated illness-3,60,000-6,00,000IU 6-10days Once a day<br>2. Mild Pneumonia-<br>3,60,000-6,00,000IU 6-10days Once a day<br>3. Severe Pneumonia-<br>3,60,000-6,00,000IU 3-5days Twice a day<br><br>Control Intervention1: Standard treatment: Standard treatment according to physicianâ??s decision, based on the current recommendations.<br>→ | 1. Difference in two study groups with respect to the duration and severity of signs and symptoms. <br/ ><br>2. Time taken for Double negative RT-PCR between the two study groups <br/ ><br>3. Duration of hospital stay. <br/ ><br>4. Difference in the blood parameters and comparable symptoms between the two groups after the intervention.Timepoint: 24 weeks→ | | | | Yes | False | | |
| → | CTRI/2020/12/030085 | 27 January 2021 | Efficacy of Mycobacterium w in preventing COVID-19 among peri-urban population of Haryana | Efficacy of Mycobacterium w in preventing COVID-19 among peri-urban population of Haryana | | SGT University | 29-12-2020 | 20201229 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50812 | Not Recruiting | No | | | | 04-01-2021 | 300 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant Blinded | Phase 3 | India→ | Narinder Pal Singh→ | | Room no 26 C block 1st floor
SGT University
→ | NANUSINGH58@GMAIL.COM→ | 9868446621→ | SGTUniversity→ | Inclusion criteria: 1.Healthy subjects of either gender, age â?¥ 18 years. <br/ ><br>2.Female subject who are currently using reliable methods of contraception (barrier methods and intrauterine contraceptive device), with a negative urine pregnancy test during screening and agree to informed compliance of contraceptive method until at least months post-dosing. <br/ ><br>3.The subject must be able and willing to comply with the study protocol, available and willing to complete all the study assessments and must have signed an Informed Consent Form. <br/ ><br>→ | Exclusion criteria: 1. Any febrile illness with oral temperature > 100°F within 3 days prior to randomization. <br/ ><br>2. Subject with past history of COVID-19 infection. <br/ ><br>3. Pregnant and / or lactating female subjects. <br/ ><br>4. Presence of any illness requiring hospital referral. <br/ ><br>5. Any confirmed or suspected immune-deficient condition based on medical history and <br/ ><br>physical examination and a family history of congenital or hereditary immunodeficiency <br/ ><br>or Individuals on immunosuppressant's as Azathioprine, Cyclosporine, Mycophenolate <br/ ><br>etc. <br/ ><br>6. History of allergic reactions or anaphylaxis to Mw or its component.→ | | Intervention1: Mw Injection: 0.1 ml would be given to healthy Subjects on Day 1 AND IF required Day 16<br>Control Intervention1: Distilled water: 0.1 ml would be given on day 1 and 16<br>→ | To evaluate the incidence of RT-PCR proved COVID-19 in Mw treated group in comparison to control group.Timepoint: 6 month→ | | | | Yes | False | | |
| → | CTRI/2020/12/030094 | 27 January 2021 | To understand and study the experiences of patients and doctors at the COVID-19 isolation wards | Experiences of patients and healthcare professionals during hospital-based source isolation for COVID-19. | | Viola Dsouza | 29-12-2020 | 20201229 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49616 | Not Recruiting | No | | | | 05-01-2021 | 20 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Lena Ashok→ | | Room No 39, Department of Global Health, Prasanna School of Public Health (PSPH), Manipal Academy of Higher Education, Opp Tiger Circle, Manipal → | lena.ashok@manipal.edu→ | 8310422623→ | Prasanna School of Public Health (PSPH)→ | Inclusion criteria: Symptomatic COVID-19 positive patients who were enrolled in an isolation ward for over 5 <br/ ><br>daysâ?? stay and those who are above 18 years of age irrespective of gender, socioeconomic status, <br/ ><br>comorbidities will be included. COVID -19 patients admitted in isolation wards will be included. Doctors working in COVID-19 isolation ward from the department of medicine will be included in the study. <br/ ><br>→ | Exclusion criteria: Asymptomatic patients, below 18 years and above 75 years will be excluded.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | We will learn about the experience of COVID-19 patients during their stay in isolation wards.Timepoint: At the baseline (while administering the questionnaire)→ | | | | Yes | False | | |
| → | CTRI/2020/12/030082 | 27 January 2021 | CYTOKINES(INFLAMMATORY MARKERS) IN SEVERE AND MODERATE COVID 19 PATIENTS AND ITS RELATION WITH THE OUTCOMES | IL-6,TNF ALPHA,INF GAMMA AND IL-1 BETA LEVELS IN SEVERE AND MODERATE COVID 19 PATIENTS AND ITS RELATION WITH OUTCOMES | | PAVULURI KRISHNA SWATHI | 29-12-2020 | 20201229 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50171 | Not Recruiting | No | | | | 30-12-2020 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | PAVULURI KRISHNA SWATHI→ | | GENERAL MEDICINE DEPARTMENT,BLOCK 5,ROOM 226 → | senthilresearch2020@gmail.com→ | 9381049376→ | SRIHER→ | Inclusion criteria: PATIENTS MORE THAN 18YEARS OF AGE AND WHO ARE RT PCR FOR SARS COV 2 PROVEN ADMITTED TO THE COVID WARD AND WHO ARE RADIOLOGICALLY MODERATE AND SEVERE COVID 19.→ | Exclusion criteria: AUTOIMMUNE DISORDERS <br/ ><br>PATIENTS ON BIOLOGIC DMARDS <br/ ><br>PREGNANCY <br/ ><br>OTHER BACTERIAL AND VIRAL INFECTIONS→ | Health Condition 1: B998- Other infectious disease
→ | | 4 CYTOKINES(IL-6,TNF ALFA,INF GAMMA AND IL-1 B) ON DAY 1 AND DAY 10,MORTALITY OR MORBIDITY.Timepoint: DAY 1 AND DAY 10 <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/12/030113 | 27 January 2021 | Analysis of Antibody (IgM & IgG) responses among symptomatic adult COVID-19 Positive patients, getting admitted to Odisha COVID Hospital, KIMS, BBSR
| Analysis of Antibody (Ig M & Ig G)Titer responses among COVID-19 infected patients in KIMS, BBSR | | NIL | 30-12-2020 | 20201230 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50776 | Not Recruiting | No | | | | 05-01-2021 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Kumudini bPanigrahi→ | | Dept. of Microbiology
KIMS, Bhubaneswar → | kumudini.panigarahi@kims.ac.in→ | | Kalinga Institute of Medical sciences, KIIT University→ | Inclusion criteria: Patients confirmed to be positive for COVID -19 infection by RT-PCR test, willing toparticipate in the study.Symptomatic, Adults of age > 18 yrs and both sexes, adult females without pregnancy.→ | Exclusion criteria: COVID- negative, not willing to participate, <18 yrs of age, Pregnant females→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | In future serological testing can be useful for screening and to know the severity of disease among COVID19 positive patients.Timepoint: At the time of admission, after one week of admission <br/ ><br>and at the time of discharge or worsening of symptoms (if before one week)→ | | | | Yes | False | | |
| → | CTRI/2020/12/030127 | 27 January 2021 | Trends of maternal mortality during COVID -19 pandemic at our tertiary care institute. | Direct and Indirect Impact of COVID-19 pandemic on maternal mortality. | | Not required | 30-12-2020 | 20201230 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49841 | Not Recruiting | No | | | | 01-01-2021 | 40 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrSunita Dubey→ | | 4th Floor
D-Block
Office of Deptt of Obstetrics & Gynecology
GMCH-32B Chandigarh → | sunitas504@gmail.com→ | 9646323268→ | Government Medical College & Hospital,Sector-32,Chandigarh→ | Inclusion criteria: All Maternal deaths that occurred at our institute during pregnancy or within 42 days of pregnancy termination as a result of pregnancy, childbirth, and the puerperium related complications and in-transit deaths in ambulance/any recognized patient transport system with reliable history & documentation of pregnancy related complications in the referral slip and confirmed at our institute after assessment of deceased will also be included.→ | Exclusion criteria: All accidental deaths like Suicide, poisoning, Snake bite, hanging, burns and road side accident will be excluded from the study. <br/ ><br>Maternal mortality due to COVID -19 infection will also be excluded. <br/ ><br>→ | Health Condition 1: O94- Sequelae of complication of pregnancy, childbirth, and the puerperium
Health Condition 2: O94- Sequelae of complication of pregnancy, childbirth, and the puerperium
→ | | To analyze trends of maternal deaths during COVID -19 pandemic and to compare it with those occurred before COVID - 19 pandemic at our tertiary care institute. Any changes in Demographic parameters of both the groups .Timepoint: Maternal mortality that occurred within 6 month before COVID-19 pandemic will be compared with (Group B) maternal mortality that happened within 6 month after declaration of lockdown in India. Maternal mortality data of year 2019 will also be analyzed to know maternal mortality ratio at our institute before COVID-19 pandemic.→ | | | | Yes | False | | |
| → | CTRI/2020/12/030165 | 27 January 2021 | To assess the body resistance improvement and to evaluate the clinical use and well-being of DailyTabâ?¢Gold immuno booster and DailyTabâ?¢Gold immuno booster (For cardiac, diabetic and neuro conditions) along with standard of care in novel corona virus (COVID-19) patients. | A double blind, placebo controlled, three arm, randomized clinical trial to evaluate the immuno boosting activity and to assess the efficacy and safety of the test products DailyTabâ?¢Gold Immuno Booster and DailyTabâ?¢Gold Immuno Booster (cardiac, diabetic and neuro conditions) Mfd. By LIFECARE NEURO PRODUCTS LTD, Himachal Pradesh (India) along with standard of care in novel corona virus (COVID-19) patients. | | LIFECARE NEURO PRODUCTS LTD | 31-12-2020 | 20201231 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50753 | Recruiting | No | | | | 08-01-2021 | 45 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Vijender Singh Beniwal→ | | 70/1, Dharampur, Sai Road,
Phase-II, Baddi.
Himachal Pradesh (INDIA). → | info@pharexcelconsulting.com→ | 9878551428→ | Pharexcel Consulting→ | Inclusion criteria: 1. Either male or female of age range 18-65 years <br/ ><br>2. Patients with mild to moderate COVID-19 infection and RT-PCR confirmed diagnosis of COVID-19. <br/ ><br>3. Subjects willing to give written informed consent and come for a regular follow up. <br/ ><br>4. Subjects willing to abide by and comply with the study protocol.→ | Exclusion criteria: 1. Patients presenting severe multisystemic symptoms compatible with advanced Covid-19 and intercurrent acute or severe chronic diseases (i.e. active cancer). <br/ ><br>2. Presence of acute hypoxic respiratory failure <br/ ><br>3. Requires Intensive care unit (ICU) care for management of ongoing clinical status <br/ ><br>4. Severe infection, defined as need for invasive or non-invasive ventilator support <br/ ><br>5. Inability to intake or tolerate oral medication <br/ ><br>6. Category 6 or 5 based on modified 7-category ordinal scale of clinical status <br/ ><br>7. Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission <br/ ><br>8. Pregnant or lactating subjects <br/ ><br>9. With any secondary complication such as diabetes, cancer, HIV or hypertension.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: DailyTabâ?¢Gold immuno booster along with standard of care: DailyTabâ?¢Gold immuno booster, Oral, One tablet daily after break-fast or lunch for 28 days.<br>Standard of care as per hospital protocol for Covid-19.<br>Intervention2: DailyTabâ?¢Gold Immuno Booster (For cardiac, diabetic and neuro conditions) along with standard of care: DailyTabâ?¢Gold Immuno Booster (For cardiac, diabetic and neuro conditions)<br>Oral, One tablet daily after break-fast or lunch for 28 days. Standard of care as per hospital protocol for Covid-19.<br>Control Intervention1: Placebo along with Standard of care: Placebo, Oral, One tablet daily after breakfast or lunch for 28 days. Standard of care as per hospital protocol for Covid-19.<br>→ | Changes in clinical cure based on clinicianâ??s global assessment of symptomsTimepoint: Day 1, Day 7, Day 14 and Day 28→ | | | | Yes | False | | |
| → | CTRI/2020/12/030164 | 27 January 2021 | National Registry for COVID in Pregnant women | National Registry on COVID-19 infection among
pregnant women and their neonates - NRCIP | | Indian Council of Medical Research | 31-12-2020 | 20201231 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50578 | Not Recruiting | No | | | | 05-01-2021 | 4650 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | N/A | India→ | Dr Reeta Rasaily→ | | Indian Council of Medical Research Ansari Nagar New Delhi → | reeta.rasaily@gmail.com→ | 01126589493→ | Indian Council of Medical Research→ | Inclusion criteria: 1.Pregnant or post natal women above 18 years of age <br/ ><br>2. Admitted in antenatal period/ labour/ postpartum period <br/ ><br>3. Positive RT-PCR for SARS-CoV-2 infection using throat or nasal swab specimens from the upper respiratory tract using ICMRâ??s standard testing protocol. <br/ ><br>4. Willing to participate in the study <br/ ><br>5. Neonates (upto 28 days) who test positive for SARS-CoV-2 infection and whose parents/ LAR give consent <br/ ><br>→ | Exclusion criteria: Those cases who are not willing to give consent will be excluded→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. Severity of disease during pregnancy <br/ ><br>2. Outcome of pregnancy in relation to severity of disease <br/ ><br>3. Outcome of fetus <br/ ><br>4. Perinatal outcome <br/ ><br>5. Neonatal outcome <br/ ><br>6. Treatment pattern <br/ ><br>Timepoint: At enrollment <br/ ><br>At delivery <br/ ><br>28 days <br/ ><br>42 days <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2020/12/030143 | 27 January 2021 | comparison of different steroid regimes in critically ill adult patients of COVID-19 | Evaluation of different steroid regimes in critically ill adult patients of COVID-19 admitted to intensive care units | | Maulana Azad Medical College and associated Lok Nayak Hospital | 31-12-2020 | 20201231 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50886 | Not Recruiting | No | | | | 07-01-2021 | 500 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable | N/A | India→ | Dr Sukhyanti Kerai→ | | Room no 413 BL Taneja block
Maulana Azad Medical College
New Delhi Maulana Azad Medical College New Delhi
Department of Anaesthesiology & Intensive Care→ | drsukhi25@gmail.com→ | 09968527122→ | Maulana Azad Medical College→ | Inclusion criteria: 1.Confirmed COVID-19 infection with pulmonary involvement <br/ ><br>2.Admitted to ICU within 14 days of onset of symptoms <br/ ><br>3.Receiving Invasive or non -invasive positive pressure ventilation or respiratory support through HFNC→ | Exclusion criteria: Septicemia <br/ ><br>2. Active malignancy or patient on immunosuppressive therapy within last 3 months <br/ ><br>2.Uncontrolled hyperglycaemia <br/ ><br>3.Clinically important gastrointestinal bleed <br/ ><br>4.Pregnancy <br/ ><br>5.History of hypersensitivity to steroid preparations <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Methylpredinesolone: Drug-Methylprednisolone<br>Dose-1 to 2 mg/kg body weight<br>Route- IV <br>Frequency- daily infusion over 24 hours<br>Duration-10 days<br>Control Intervention1: Dexamethasone <br>: Drug-Dexamethasone<br> Dose- 6 mg<br> Route- IV<br> Frequency- once<br> Duration-10 days<br><br> <br><br>→ | 28 day Mortality of patientsTimepoint: 28 days→ | | | | Yes | False | | |
| → | CTRI/2020/12/030156 | 27 January 2021 | Orientation of time, stress, and well-being of Middle-aged Employees during the Covid-19 Pandemic | Time Perspective, Perceived Stress, and Mental Well-being of Middle-aged Employees under the Covid-19 Pandemic Conditions | | Anuradha Mukherjee | 31-12-2020 | 20201231 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50914 | Not Recruiting | No | | | | 13-01-2021 | 130 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Anuradha Mukherjee→ | | Department of Psychology, Manipal College of Health Professions, Manipal Dr, Madhav Nagar, Manipal, Karnataka 576104 → | indu.toby@manipal.edu→ | 9482784595→ | Manipal College of Health Professions→ | Inclusion criteria: Employees of Manipal Academy of Higher Education in the age group of 40-55 years→ | Exclusion criteria: Presence of physical impairment. Those who self-identify as having undergone psychiatric/ psychological intervention within the past 6 months.→ | | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | 5 scores will be obtained from the Zimbardo Time Perspective Inventory (ZTPI), 1 likert score from the Warwick-Edinburgh Mental Well-being Scale (WEMWBS), and 1 score from the COVID Stress Scale to be comparedTimepoint: Test ratings recorded at the time of providing test responses i.e. baseline ratings→ | | | | Yes | False | | |
| → | CTRI/2021/01/030169 | 27 January 2021 | Study to evaluate the effect of two herbal drugs NIFAy.C-19(CONTAZAP)and AYUSH 64 in corona patients. | Clinical study to evaluate the efficacy of NIFAy.C-19 (CONTAZAP) in mild to moderate COVID-19 positive patients: A randomized open label parallel group study. | | National Innovation FoundationIndia | 01-01-2021 | 20210101 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50842 | Not Recruiting | No | | | | 04-01-2021 | 120 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Dr N R Singh→ | | Room No. G31, Office of Additional Director(Academics) Ch. Brahm Prakash Ayurved Charak Sansthan Khera Dabar, Post Office-Ujva District-South West, New Delhi → | naimishraj@yahoo.com→ | 9560659728→ | Ch. Brahm Prakash Ayurved Charak Sansthan→ | Inclusion criteria: 1.Patients tested positive for SARS-CoV2 virus infection <br/ ><br>2.Patients having one or more symptoms of mild to moderate category of COVID-19 infection. <br/ ><br>3 Patients of either sex. <br/ ><br>4.Age: 18 years to 80 years. <br/ ><br>5.Patients who can take oral medicines <br/ ><br>6.Patients who are ready to give consent to participate in the study. <br/ ><br>→ | Exclusion criteria: 1.Patients having severe symptoms of COVID-19 infection. <br/ ><br>2.Age below 18 years and more than 80 years. <br/ ><br>3.Patients requiring intubation or mechanical ventilators. <br/ ><br>4.Pregnant and lactating women. <br/ ><br>5.Oncological disease and other systematic un-controlled condition <br/ ><br>6.RFT â?¥ 2.5 times of the upper limit. <br/ ><br>7.Patients participating in other trial <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Cap.NIFAy.C19(CONTAZAP)-640 mg a polyherbal formulation: The composition of NIFAy.C-19 (CONTAZAP) includes aqueous extract of Kalmegh (Andrographis panniculata Nees), Revand Chini (Rheum emodi Wall.ex.Meisn) and Amalaki (Embelica officinalis) in the ratio of 2:1:5 Dose: 2Cap.twice daily Time of administration:After meal.Dosage form : Capsule Anupana: Lukewarm water Route of Drug Administration-Oral Route<br>Duration of therapy: 7 days/14 days as per requirement<br>Control Intervention1: Tab. AYUSH-64, a polyherbal formulation.: The composition of AYUSH 64 includes aqueous extract of Saptaparna (Alstoniascholaris R. Br.) Katuki (Picrorhizakurroa<br>Royle ex. Benth), Kiratatikta(SwertiaChirataPexbex. Karst)<br>and powder of Kuberaksha(Caesalpinia crista Linn.) in the<br>ratio of 1:1:1:2 Dose: 2 tablets twice daily.Dosage form: Tablets, Time of drug administration- After meal Route of Drug Administration- Oral Route<br>Anupana- Lukewarm water<br>Duration of Therapy- 7 days /14 days as per requirement <br><br>→ | a) Mean time (days) for clinical recovery as per clinical recovery criteria. <br/ ><br>b) Number of patients showing â??clinical <br/ ><br>recoveryâ?? <br/ ><br>Timepoint: a) at baseline, 8th day, 14th day, 21st day (if required) showing â??clinical <br/ ><br>recoveryâ?? <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/01/030186 | 27 January 2021 | Periodic Change in Antibody titers against SARS-CoV-2 among COVID-19 positive patients: A Observational Cohort Study | Periodic change in antibody titers against SARS-CoV-2 among COVID-19 positive patients: A observational cohort study | | Indian Council of Medical Research New Delhi | 01-01-2021 | 20210101 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49335 | Not Recruiting | No | | | | 11-01-2021 | 84 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Debdutta Bhattacharya→ | | Chandrasekharpur, Bhubaneswar
Odisha - 751023 Chandrasekharpur, Bhubaneswar
Odisha - 751023→ | drdebdutta.bhattacharya@yahoo.co.in→ | | ICMR - Regional Medical Research Centre, Bhubaneswar→ | Inclusion criteria: The patients must be COVID-19 confirmed positive and having antibody developed after 21 days of detection. All patient will be tested for Antibody against SARS-CoV-2 before enrolment and those who have antibody will be enrolled.→ | Exclusion criteria: The patients who havenâ??t developed antibody even after 21 days of detection will not to be enrolled for follow up in this study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | Anti SARS-CoV-2 IgG Antibodies are gradually waning with time among all the recovered COVID-19 positive patients.Timepoint: 16 weeks with a frequency of every fortnight.→ | | | | Yes | False | | |
| → | CTRI/2021/01/030231 | 27 January 2021 | A randomized, two treatment group clinical study to evaluate the effectiveness and safety of study drug 2-Deoxy-D-Glucose with SOC compared to SOC alone in treatment of moderate to severe COVID-19 patients | A Randomized, Open Label 2-Treatment Group Clinical Trial Evaluating the Efficacy and Safety of 2-Deoxy-D-Glucose as an adjunctive therapy to standard of care, in comparison to standard of care alone, in the Acute Treatment of moderate to severe COVID-19 patients - NA | | Institute of Nuclear Medicine and Allied Sciences INMAS | 04-01-2021 | 20210104 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50985 | Not Recruiting | No | | | | 12-01-2021 | 220 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | Phase 3 | India→ | Dr D Mallikarjuna Rao→ | | Dr Reddys Laboratories Limited IPDO, Innovation Plaza Bachupally Hyderabad → | anant@inmas.drdo.in→ | | Division of Radiation Biosciences Institute of Nuclear Medicine→ | Inclusion criteria: 1. Male, female and transgender patients aged â?¥ 18 years <br/ ><br>2. Patients testing positive for SARS-CoV-2 by rRT-PCR on a nasopharyngeal or oropharyngeal swab <br/ ><br>Note: A re-treated/ relapsed patient may be enrolled if he/she meets <br/ ><br>all of the following criteria: <br/ ><br>a. Documented re-conversion on nasopharyngeal or oropharyngeal swab from negative to positive for SARSCoV <br/ ><br>2 OR nasopharyngeal or oropharyngeal swab continues to be positive for SARSCoV-2 after previous treatment <br/ ><br>AND <br/ ><br>b. Clinical symptoms associated with COVID-19 (fever, cough, fatigue, shortness of breath, expectoration, myalgia, rhinorrhea, sore throat, diarrhea, anosmia, ageusia) have either re-appeared after previous treatment <br/ ><br>OR continued to be present without improvement OR are aggravated <br/ ><br>c. Patient meet the below-mentioned criterion number 3 for moderate or severe COVID-19 disease severity <br/ ><br>3. Patients clinically assigned as moderate [Presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% range 90-94% on room air, Respiratory Rate more or equal to 24 per minute] or severe (Clinical signs of Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air) but not critically ill (acute respiratory distress syndrome [ARDS], multi organ failure or septic shock) <br/ ><br>4. Patients with a score of â?¥ 5 (â??hospitalized, on oxygenâ??) on the 10- point ordinal scale of clinical status used by WHO in the SOLIDARITY trial at baseline assessment. <br/ ><br>5. Females should have a negative serum pregnancy test at baseline; female patients of child bearing potential should either be abstinent or comply with one or more contraception methods (with low user dependency and failure rate of <1%) for the entire duration of the treatment period and until 90 days after receiving the last dose of study treatment <br/ ><br>6. Able and willing to provide informed consent <br/ ><br>7. Able to understand the trial requirements and comply with trial medications and assessments in the opinion of the Investigator <br/ ><br>8. Agrees not to participate in other clinical studies within 30 days after the last administration of the study treatment <br/ ><br>→ | Exclusion criteria: Patients who meet any of the following criteria will be disqualified from <br/ ><br>entering the study: <br/ ><br>1. Critically ill patients, defined as those who are candidates for endotracheal intubation and invasive mechanical ventilation and those with ARDS, septic shock or multi-organ failure at baseline <br/ ><br>2. Patients in whom the first onset of symptoms/signs suggestive of COVID-19 illness was observed >10 days earlier to the baseline assessment and randomization <br/ ><br>3. Patients with previous history of hypersensitivity or a contraindication <br/ ><br>to the IMP 2-deoxy-D-glucose or the imaging marker Fluorodeoxyglucose (FDG) <br/ ><br>4. Patients with history of one or more known comorbidities at <br/ ><br>baseline: <br/ ><br>a. Cardiac Failure <br/ ><br>b. Prior or concurrent ischemic coronary artery disease (CAD): angina pectoris, history of myocardial infarction or documented silent ischemia or coronary artery vasospasm, including Prinzmetalâ??s angina <br/ ><br>c. Cardiac conduction delay (QTc > 500 msec) or taking any medications known to prolong QT interval <br/ ><br> d. Wolff-Parkinson-White syndrome or arrhythmias associated with other cardiac accessory conduction pathway disorders <br/ ><br>e. Uncontrolled Diabetes Mellitus or any condition predisposing to hypoglycaemia <br/ ><br>f. Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) <br/ ><br>g. Asthma or Interstitial Lung Disease <br/ ><br>h. Malignancy <br/ ><br>i. Chronic Kidney Disease <br/ ><br>j. Other severe underlying diseases (e.g., active bleeding, blood dyscrasias, severe malnutrition) <br/ ><br>k. Presence of any contra-indication to the chosen Standard of Care treatment <br/ ><br>5. Patients who are receiving drugs known to prolong the QT interval of heart including hydroxychloroquine or azithromycin OR are expected to require treatment with the same during the treatment period in the study (as of baseline assessment). <br/ ><br>6. Received interferon alpha or experimental biological therapies ( eg. ACE-2 decoy or monoclonal antibodies against SARS-CoV-2) in the 90 days prior to baseline visit. <br/ ><br>Note: Convalescent plasma therapy and drugs/ biological therapies that have received approval for â??emergency useâ?? for the treatment of COVID-19 from the Drug Regulatory Authority are permitted as part of Standard of care or as â??rescueâ?? treatments in the trial. <br/ ><br>7. Any other therapy which may confound the interpretation of efficacy outcomes or increase safety risks to patients. This includes patients receiving other investigational therapies for COVID-19. <br/ ><br>8. Inability to take oral medication. <br/ ><br>9. Patients with malabsorption or gastrointestinal abnormalities which may affect drug absorption <br/ ><br>10. Body Weight < 45 kg or >130 kg <br/ ><br>11. Female patients who are pregnant or lactating <br/ ><br>12. Patients who have received organ transplantation in the last 6 months or currently on immunosuppressive therapy (eg. Methotrexate, Cyclosporine, etc.) <br/ ><br>13. Patients who are contemplating surgery/ female patients contemplating a pregnancy within 90 days after scheduled end of study treatment <br/ ><br>14. Patients who are not suitable to participate in the study based on the Investigatorâ??s judgement <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 90 mg/kg body weight/ day 2-Deoxy-D-Gluclose and SOC: 2-Deoxy-D-Gluclose 45 mg/kg body weight AM plus 45 mg/kg body weight PM for 10 days or until discharge, whichever earlier <br><br>SOC as required<br>Control Intervention1: Standard of Care Only: for 10 days or until discharge<br>→ | 1. To evaluate the efficacy of 2-Deoxy-D-Glucose (2-DG) as an adjunctive therapy to standard of care (SoC), in comparison to SoC alone, in the acute treatment of moderate to severe COVID-19 patients <br/ ><br>2. To evaluate the safety of 2-DG as an adjunctive therapy to standard of care (SoC), in comparison to SoC alone, in the acute treatment of moderate to severe COVID-19 patients <br/ ><br>Timepoint: entire duration of Trial→ | | | | Yes | False | | |
| → | CTRI/2021/01/030202 | 27 January 2021 | Challenges encountered by person with disability during COVID-19 | Perception of the impact of COVID-19 pandemic and nation-wide lockdown on individuals with disabilities: exploring Indian blogs and forum | | Dr Girish N | 04-01-2021 | 20210104 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51001 | Not Recruiting | No | | | | 17-01-2021 | 30 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sidhiprada Mohapatra→ | | Department of Physiotherapy, 2nd Floor, Manipal College of Health Professions, MAHE, Manipal → | girish.n@manipal.edu→ | 9886782114→ | Manipal College of Health Professions, MAHE→ | Inclusion criteria: Any age group, <br/ ><br>Either genders, blogs published by Indian authors which are related to any disabilities, blogs from 25.03.2020 to 19.10.2020 will be included.→ | Exclusion criteria: → | Health Condition 1: Q00-Q99- Congenital malformations, deformations and chromosomal abnormalities
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: M00-M99- Diseases of the musculoskeletal system and connective tissue
Health Condition 4: G00-G99- Diseases of the nervous system
Health Condition 5: F01-F99- Mental, Behavioral and Neurodevelopmental disorders
Health Condition 6: G57- Mononeuropathies of lower limb
→ | Intervention1: NA: NA<br>→ | HDM-DCP ModelTimepoint: 31.01.2021 <br/ ><br>6 months→ | | | | Yes | False | | |
| → | CTRI/2021/01/030212 | 27 January 2021 | Managing problems of any food or bone or object impaction in food tract during Covid pandemic | Management of complications of esophageal foreign body in adults during COVID-19 pandemic in a tertiary care hospital in Chengalpat district, Tamil nadu | | Karpaga Vinayaga Institute of Medical Sciences | 04-01-2021 | 20210104 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51005 | Not Recruiting | No | | | | 11-01-2021 | 10 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr G N Nikisha→ | | Department of ENT, Karpaga Vinayaga Institute of Medical Sciences → | sheetal86k@gmail.com→ | | Karpaga Vinayaga Institute of Medical Sciences→ | Inclusion criteria: o Patients who had undergone rigid esophagoscopy for foreign body esophagus during COVID-19 pandemic→ | Exclusion criteria: o Foreign body larynx <br/ ><br>o Foreign body trachea <br/ ><br>→ | Health Condition 1: T181- Foreign body in esophagus
→ | Intervention1: nil: nil<br>Control Intervention1: Nil: Nil<br>→ | To study the factors responsible for various complications of esophageal foreign body in adults during COVID-19Timepoint: 0, 1, 7, 30 days→ | | | | Yes | False | | |
| → | CTRI/2021/01/030197 | 27 January 2021 | CORRELATION OF HRCT CHEST IMAGING FINDINGS WITH DISEASE STATUS IN
COVID-19 PATIENTS | CLINICO-RADIOLOGICAL EVALUATION AND CORRELATION OF
HRCT CHEST IMAGING FINDINGS WITH DISEASE STATUS IN
COVID-19 PATIENTS | | Kalinga Institute of Medical Science | 04-01-2021 | 20210104 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49519 | Not Recruiting | No | | | | 10-01-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Sreedhar Mohan Menon→ | | Deparment of Radio-Diagnosis, Kalinga Institute of Medical Sciences, KIIT Campus 5, KIIT Road, Patia, Bhubaneswar, Odisha 751024 → | kamal.sen@kims.ac.in→ | 9539593892→ | Kalinga institute of Medical Sciences→ | Inclusion criteria: All COVID 19 positive patients who have undergone HRCT Chest on admission and repeat scan.→ | Exclusion criteria: 1. Clinically suspected COVID cases who are negative on RT-PCR testing. <br/ ><br>2. COVID positive patients, who have not undergone HRCT chest.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. To identify the imaging features of COVID19 on HRCT Chest. <br/ ><br>2. To correlate the HRCT Chest findings with clinical severity of the disease. <br/ ><br>3. To analyse the temporal changes in imaging findings on HRCT Chest over the course of the disease. <br/ ><br>Timepoint: 6 WEEKS→ | | | | Yes | False | | |
| → | CTRI/2021/01/030213 | 27 January 2021 | Assessment of Risks of corona virus Infection in Health Care Workers at a Tertiary Cancer Care Centre With COVID Care Facility | Assessment of Risk of SARS COV 2 Infection amongst Health Care Workers at a Tertiary Cancer Care Centre With COVID Care Facility | | Tata Memorial Hospital | 04-01-2021 | 20210104 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50861 | Not Recruiting | No | | | | 11-01-2021 | 2000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sandeep Tandon→ | | Department of Pulmonary Medicine, Chest OPD Room No 401, 4th Floor Annex Building Complex, → | sptandon@gmail.com→ | 02224174637→ | Tata Memorial Hospital→ | Inclusion criteria: 1.Staff who tested positive for SARS Cov-2 <br/ ><br>2.Pre-Op patients tested for SARS Cov-2→ | Exclusion criteria: Not Any→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Comparison between Risk of SARS CoV-2 to HCWs working in Dedicated Covid Care Area and those working in Routine Cancer Care AreaTimepoint: <br/ ><br>after completion of data entry→ | | | | Yes | False | | |
| → | CTRI/2021/01/030241 | 27 January 2021 | Pattern of COVID 19 infection in different age groups | Comparative study of COVID 19 infection in young, middle aged and old patients | | Pramukhswami Medical College | 05-01-2021 | 20210105 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50515 | Not Recruiting | No | | | | 11-01-2021 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Umang Patel→ | | Department of Medicine, Pramukhswami Medical College,
Karamsad Pramukhswami Medical College,
Karamsad→ | bhalendusv@charutarhealth.org→ | 02692228171→ | Pramukhswami Medical College, Karamsad→ | Inclusion criteria: All patients who are COVID-19 positive by RT-PCR/ Rapid Antigen Test and admitted at COVID isolation areas of Shree Krishna Hospital, Karamsad will be included in this study.→ | Exclusion criteria: Any patient admitted as suspect-Covid in isolation area, but found to be RT-PCR negative.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J101- Influenza due to other identifiedinfluenza virus with other respiratory manifestations
→ | | To determine and compare clinical, biochemical and radiological profile of young ( 18-35 years), middle aged(36-64 years)and old ( 64 years) admitted patients of COVID 19, their correlation with various comorbidities, and their outcome.Timepoint: Baseline.→ | | | | Yes | False | | |
| → | CTRI/2021/01/030242 | 27 January 2021 | Covid 19 among healthcare professionals | Multifactorial analysis of COVID 19 infection among healthcare professionals | | Instituton Pramukhswami Medical College Karamsad | 05-01-2021 | 20210105 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51037 | Not Recruiting | No | | | | 11-01-2021 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr BhoomiKUmar Patel→ | | Department of Medicine, Pramukhswami Medical College,
Shree Krishna Hospital,
Karamsad → | bhalendusv@charutarhealth.org→ | 02692228171→ | Pramukhswami Medical College, Karamsad→ | Inclusion criteria: Inclusion: All healthcare professionals admitted at Shree Krishna Hospital who have had suffered from COVID 19 (RT-PCR positive) during the period of 1st March 2020 to 31st December, 2020.→ | Exclusion criteria: Exclusion criteria: All healthcare professionals who have taken treatment on outdoor basis.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J22- Unspecified acute lower respiratory infection
→ | Control Intervention1: NIL: Not Applicable<br>→ | Clinical profile of COVID among healthcare professionalsTimepoint: at baseline, during course of illness, at the time of discharge from the hospital→ | | | | Yes | False | | |
| → | CTRI/2021/01/030236 | 27 January 2021 | Effectiveness of Hypertonic saline nasal irrigation and gargling in COVID-19 | Effectiveness of Hypertonic saline nasal irrigation and gargling in COVID-19 patients - A randomised controlled trial. | | V M Hemlata Katiyar | 05-01-2021 | 20210105 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50290 | Not Recruiting | No | | | | 18-01-2021 | 96 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Alternation Blinding and masking:Open Label | N/A | India→ | Dr V M Hemlata Katiyar→ | | Department of ENT,
Govt medical college,
East Yakkara
Palakkad rashmi, ML colony, Kunnathurmedu
Palakkad→ | hemayush@gmail.com→ | 9444124853→ | Govt Medical college (IIMS), Palakkad→ | Inclusion criteria: 1. Adults (â?¥18 years) <br/ ><br>2.Those presenting with any of the following: <br/ ><br>a. Clinical symptoms suggestive of COVID-19 (i.e. those who have at least one of the following symptoms: <br/ ><br> recent onset of <br/ ><br> i) new continuous cough and/or <br/ ><br> ii) high temperature) and/or <br/ ><br> iii) loss of, or change in, sense of smell or taste (anosmia) and /or <br/ ><br>b. Those with virologically confirmed SARS-CoV-2 infection and are admitted at the CFLTC or DH, Palakkad. <br/ ><br>3. Provision of informed consent <br/ ><br>→ | Exclusion criteria: 1. People â?¤17 years <br/ ><br>2. Inability to consent <br/ ><br>3. Pregnancy <br/ ><br>4. Immunosuppression <br/ ><br>5. Inability to perform HSNIG <br/ ><br>6. Those taking part in another interventional medical trial <br/ ><br>7. Those without access to a supply of salt <br/ ><br>8. Those who have had a negative COVID-19 swab result for the present symptoms <br/ ><br>9. Those who opt for home isolation after testing Covid positive. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 1.5% to 3% Saline nasal irrigation and gargling: saline nasal irrigation and gargling minimum of 3 times to maximum of 10 times daily for 7 days or till asymptomatic whichever is earlier<br>Control Intervention1: standard of care as per Covid protocol: Symptomatic treatment e.g. Paracetamol for fever, provided to admitted patients for 7 days<br>→ | Self-reported time to resolution as assessed by completion of the validated self-reported, modified, short form of the Wisconsin Upper Respiratory Symptom Survey (WURSS-24), which will be used to collect daily symptom data.Timepoint: end of illness or 07 days→ | | | | Yes | False | | |
| → | CTRI/2021/01/030235 | 27 January 2021 | Lung Function Test in Post Covid patients: An Observational Study. | Lung Function Indices Measured by Forced Oscillation Test in Post Covid patients: An Observational Study. | | Dr Nagesh Dhadge | 05-01-2021 | 20210105 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51076 | Recruiting | No | | | | 12-01-2021 | 50 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Nagesh Dhadge→ | | CGHS Wellness Center No. 5 Room No 3 Armament Colony Campus, Ganeshkhind Road Pune Central Government Health Scheme(CGHS) Swasthya Sadan, Mukund Nagar
Pune
MAHARASHTRA
411007
India→ | ndhadge@hotmail.com→ | 9822327445→ | Central Health Services, Pune.India→ | Inclusion criteria: 1. Participant who is willing to provide written informed consent. <br/ ><br> <br/ ><br>2. Male and female patients (age- 5 years to 80 years ) who have had tested positive for COVID19 on polymer chain reaction test (PCR) or rapid antigen test and recovered <br/ ><br>→ | Exclusion criteria: 1. Pregnant women. <br/ ><br> <br/ ><br>2. Participant unwilling to sign an informed consent form <br/ ><br> <br/ ><br>3. Patients with purulent sputum, oxygen saturation less than 90, patients on supplemental oxygen. <br/ ><br> <br/ ><br>4. Those having signs of active lower respiratory tract infection on clinical examination. <br/ ><br> <br/ ><br>5. Those who cannot perform lung function test, patients having active chest pain. <br/ ><br> <br/ ><br>6. Haemoptysis of unknown origin, pneumothorax, unstable angina pectoris, myocardial infarction, thoracic aneurysms, abdominal aneurysms, cerebral aneurysms, recent eye surgery (within 2 weeks due to increased intra ocular pressure during forced expiration), abdominal or thoracic surgical procedures within past 1 month, and patients with a history of syncope associated with forced exhalation. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J841- Other interstitial pulmonary diseases with fibrosis
→ | | What are the characteristics of resistance and reactance measured by FOT in post COVID-19 period after discharge and on further follow up after one month?Timepoint: 0 and 1 month→ | | | | Yes | False | | |
| → | CTRI/2021/01/030244 | 27 January 2021 | Clinico-Demographic Profile And Morbidity Of Percutaneous Nephrolithotomy | Clinico-Demographic Profile & Morbidity Of Percutaneous Nephrolithotomy(Pcnl) â?? An Observational Analytical Study | | University College of Medical Sciences University of Delhi | 05-01-2021 | 20210105 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51152 | Not Recruiting | No | | | | 18-01-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | N/A | India→ | Divya GS→ | | Department of Surgery University College of Medical Sciences University of Delhi and GTB Hospital Delhi 110095 Department of Surgery University College of Medical Sciences University of Delhi and GTB Hospital Delhi 110095→ | divyagsk5513@gmail.com→ | 9964653032→ | University College of Medical Sciences University of Delhi & GTB Hospital→ | Inclusion criteria: 1. Patients aged 18-80 years who underwent PCNL in our institution during 30/10/2009 to 30/10/2019. <br/ ><br>2. All consenting scheduled/elective patients with renal stones admitted and planned for PCNL upto year 2022 in our institution. <br/ ><br>→ | Exclusion criteria: 1. Patients with incomplete medical records For retrospective cases <br/ ><br>2. For prospective cases : Patients with prior untreated urinary tract infections, Patients with history of uncorrected coagulopathy. <br/ ><br>→ | Health Condition 1: N200- Calculus of kidney
→ | Intervention1: Nil: Nil<br>Intervention2: PCNL: All cases subjected to PCNL Retrospective ± Prospective Study (subject to conversion of hospital to Non-COVID facility<br>→ | Prevalence of clinico-demographic profile of morbidity, intra and peri-operative complications shall be assessed by: <br/ ><br>(1) Modified Clavien Dindo classification <br/ ><br>(2) Other ergonomic parameters like <br/ ><br>(i) Mean duration of hospital / ICU stay <br/ ><br>(ii) Mean rate of sepsis/SIRS <br/ ><br>(iii) Intra-operative parameters <br/ ><br>(iv) Stone free status <br/ ><br>(v) Auxiliary treatment rate <br/ ><br>(vi) Incidence of re-admission within 30 days <br/ ><br>Timepoint: 1. Time till Discharge <br/ ><br>2. 30 Days after Discharge (Readmission) <br/ ><br>3. 6 weeks post discharge→ | | | | Yes | False | | |
| → | CTRI/2021/01/030297 | 27 January 2021 | Prevalence of depression, anxiety, and stress among physiotherapy students and interns | Prevalence of depression, anxiety, stress among physiotherapy students in Bangladesh: A cross-sectional study during COVID-19 pandemic - DASS-PT Student | | Uttara Adhunik Medical College and Hospital | 06-01-2021 | 20210106 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51101 | | No | | | | 13-01-2021 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Bangladesh→ | Dr Mohammad Ali→ | | Department of Physiotherapy and Rehabilitation.
Room no 01
House 34
Road 04
Uttara
Dhaka
Bangladesh → | alibup2018@gmail.com→ | 88-01715043533→ | Uttara Adhunik Medical College and Hospital→ | Inclusion criteria: Students of BSc in Physiotherapy in Bangladesh→ | Exclusion criteria: Completed Internship <br/ ><br>Do not give informed consent→ | | | Depression, anxiety, stress and suicidalityTimepoint: At the time of study→ | | | | Yes | False | | |
| → | CTRI/2021/01/030316 | 27 January 2021 | Symptoms of COVID and its relation with severity | Sequence of symptomatology of SARS-CoV infection and its correlation with disease severity and progression | | SRIHER | 07-01-2021 | 20210107 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47274 | Not Recruiting | No | | | | 18-01-2021 | 320 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Krishnan Vasanthan→ | | Sri Ramachandra university No:1 , Ramachandra nagar ,porur , chennai Sri Ramachandra university No:1 , Ramachandra nagar ,porur , chennai→ | drvasanthan2007@gmail.com→ | 9940269132→ | SRIHER→ | Inclusion criteria: 1. All confirmed cases of SARS- Cov-2 â?¥ 18 years of age <br/ ><br>2. Patients should possess acceptable level of hearing <br/ ><br>3. Willingness to share their symptoms at onset and during follow up <br/ ><br>4. Patient should know Tamil or English <br/ ><br>5. Have to possess a personal mobile phone <br/ ><br>→ | Exclusion criteria: 1. Patients with prior cognitive dysfunction which affects memory <br/ ><br>2. Patients with end stage disease- ESRD, CCF, cirrhosis, advanced malignancy <br/ ><br>3. Prior history of psychiatry illness or symptoms suggestive of depression. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | correlation between symptom sequence and severity of illnessTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/01/030319 | 27 January 2021 | A study on knowledge,attitude and behavior of undergraduate students of medical field on practices which are useful and required to prevent COVID 19 Pandemic | Knowledge, attitude and behavior on infection prevention and control practices of undergraduate medical and paramedical students | | NONE | 07-01-2021 | 20210107 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50887 | Not Recruiting | No | | | | 01-02-2021 | 600 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Chirag Modi→ | | Department of Microbiology Pramukhswami Medical College Gokalnagar Karamsad → | chiragmm@charutarhealth.org→ | 9727739203→ | Pramukhsami Medical College→ | Inclusion criteria: Shree Krishna Hospital is affiliated with medical college, Physiotherapy College, Nursing <br/ ><br>College and Medical Laboratory Technology College.All Medical and Paramedical students.→ | Exclusion criteria: NONE→ | | | Level of Knowledge, attitude and behavior on infection prevention and control practices of undergraduate medical and paramedical studentsTimepoint: 2 Month→ | | | | Yes | False | | |
| → | CTRI/2021/01/030333 | 27 January 2021 | An eKnee School for patients suffering from knee osteoarthritis | Establishing eknee School for knee osteoarthritis patients during COVID19- A quasi experimental study
| | PGIMER | 08-01-2021 | 20210108 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50964 | Not Recruiting | No | | | | 10-01-2021 | 126 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Prof Amarjeet Singh→ | | Head of the Department
Department of Community Medicine and SPH
PGIMER
Chandigarh → | drdhillon@gmail.com→ | | PGIMER→ | Inclusion criteria: Agree to alter their lifestyle and willing to follow up. <br/ ><br> Are aged 40 - 65 years of either gender. <br/ ><br> Kellgren/Lawrence [K/L] (grade â?¥1). <br/ ><br> Patients having knee pain, the presence of osteophytes in the patellofemoral joint on 30° flexion lateral radiographs. <br/ ><br> IT savvy - patient or caregiver <br/ ><br>→ | Exclusion criteria: The study will exclude patients awaiting surgery, those with deformity or intra-articular pathology, and those who have undergone hip or unilateral knee replacement, significant cardiac co-morbidity, body mass index [BMI] >40 or any comorbidity not allowing proper exercise protocol.→ | Health Condition 1: M179- Osteoarthritis of knee, unspecified
Health Condition 2: M179- Osteoarthritis of knee, unspecified
→ | Intervention1: set of exercises, Dos & Donâ??t, Yoga, meditation, dietary management & lifestyle modifications: Links of the sessions will be provided to the patients (set of exercises, Dos & Donâ??t, Yoga, meditation, dietary management & lifestyle modifications) after the recruitment. All the enrolled patients will be provided with e-link of patient education booklets containing the details of various components e.g., descriptions and pictures of the set of exercises. Customization of the exercises in consultation with orthopaedic surgeon, a physiotherapist, and patients/caregivers will be done. Online supervised group sessions will be held by physiotherapists, Orthopaedists, and other experts for six months.<br>Control Intervention1: Routine OPD care: Routine OPD care<br>→ | EQ5DL <br/ ><br>WOMAC <br/ ><br>VAS <br/ ><br>ICERTimepoint: Baseline and Endline(6 months) <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/01/030341 | 27 January 2021 | The outcome of Remdesivir and Tocilizumab in COVID 19. | To study the outcome of COVID 19 positive patients who have received Remdesivir or Tocilizumab or their combination during their treatment in a tertiary care hospital. | | Seth G S Medical College and KEM Hospital Mumbai | 08-01-2021 | 20210108 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51287 | Not Recruiting | No | | | | 17-01-2021 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sushrut Ingawale→ | | Department of General Medicine
Seth G S Medical college and KEM hospital, Mumbai 1177 Krishna Clinic, Phulewadi
Kolhapur, Maharashtra→ | drvagupta@gmail.com→ | | Seth GSMC and KEM Hospital, Mumbai→ | Inclusion criteria: 1.Laboratory confirmed COVID 19 adults (Age > 18 years) admitted in KEM Hospital. <br/ ><br>2.Patients in ICMR group 2B and onwards. <br/ ><br>3.Received any of the following drugs alone or in combination: Remdesivir, Tocilizumab.→ | Exclusion criteria: 1. Suspected COVID 19 patients. <br/ ><br>2. Positive patients in category 1A to 2A <br/ ><br>3. Pregnant/Lactating patients. <br/ ><br>4. Mortality within 24 hours of admission.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1)To assess the outcome of COVID 19 positive patients who have received Remdesivir or Tocilizumab or their combination. <br/ ><br>2)To observe the clinical factors affecting the outcome. <br/ ><br> <br/ ><br>Timepoint: 1)1 month. <br/ ><br>2)1 month.→ | | | | Yes | False | | |
| → | CTRI/2021/01/030344 | 27 January 2021 | A study of blood group in COVID-19 patients admitted at tertiary care hospital, Ahmedabad | A study of blood group in COVID-19 patients â?? An institutional study | | Arpit Prajapati | 08-01-2021 | 20210108 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50637 | Not Recruiting | No | | | | 28-01-2021 | 600 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Arpit C Prajapati→ | | Room no. 05 Community Medicine Department, Third Floor, College Building, Opp. DRM Office, NAroda Road Ahmedabad 380025 Room no. 05 Community Medicine Department, Third Floor, College Building, Opp. DRM Office, NAroda Road Ahmedabad 380025→ | doc.arpitprajapati@gmail.com→ | 09978537231→ | GCS Medical College, Ahmedabad→ | Inclusion criteria: All COVID-19 patients admitted at GCS Medical College, Hospital & Research Centre during one month period <br/ ><br>→ | Exclusion criteria: Those patients whose blood group wads not done→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To find association between ABO and Rh blood group and COVID-19 (Mechanical Ventilation, and death). <br/ ><br>Timepoint: To find association between ABO and Rh blood group and COVID-19 (Mechanical Ventilation, and death) within 1 month. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/01/030363 | 27 January 2021 | Serological response to COVID-19 and association with MR containing vaccine | Assessment of serological response to COVID-19 and its association with exposure to MR-containing vaccine: A pilot study | | University College of Medical Sciences | 11-01-2021 | 20210111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50953 | Not Recruiting | No | | | | 15-01-2021 | 60 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Jahnavi Shrivastava→ | | Department of Pediatrics, University College of Medical Sciences → | manish_2710@yahoo.com→ | 9811036569→ | University College of medical sciences & Guru Tegh Bahadur Hospital→ | Inclusion criteria: Group 1: COVID-19 positive children who have received MR-containing vaccine atleast 6 weeks before date of enrolment <br/ ><br>Group 2: COVID 19 positive children who have not received MR containing vaccine→ | Exclusion criteria: Children with past infection due to measles or rubella, immunodeficiency states (both primary and secondary), chronic diseases (congenital heart disease, respiratory diseases that cause pulmonary function impairment, hypothyroidism, IDDM), history of blood transfusion within last 3 months, severe malnutrition (wt-for-ht <-3SD, MUAC <11.5cm, or bilateral pedal edema of nutritional origin), malignancy <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Comparison of COVID-19 antibody titres between vaccinated and unvaccinated childrenTimepoint: At 2, 6 and 12 weeks from date of positive test→ | | | | Yes | False | | |
| → | CTRI/2021/01/030364 | 27 January 2021 | EVALUATING THE CT PATTERNS ASSOCIATED WITH COVID-19 FROM CHEST CT BY USING ARTIFICIAL INTELLIGENCE | EVALUATION OF AUTOMATED QUANTIFICATION OF CT PATTERNS ASSOCIATED WITH COVID-19 FROM CHEST CT | | KALINGA INSTITUTE OF MEDICAL SCIENCES | 11-01-2021 | 20210111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49740 | Not Recruiting | No | | | | 01-02-2021 | 500 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Participant and Investigator Blinded | N/A | India→ | YALAMANCHI RAJESH→ | | DEAPARTMENT OF RADIO DIAGNOSIS,CAMPUS-5,KIMS,KIIT ROAD,PATIA,BHUBANESWAR → | kamal.sen@kims.ac.in→ | 9491757599→ | KALINGA INSTITUTE OF MEDICAL SCIENCES→ | Inclusion criteria: 1. RT-PCR positive HRCT chest scans having <br/ ><br> positive imaging findings. <br/ ><br>2. Scans analyzed by AI algorithm. <br/ ><br>→ | Exclusion criteria: 1. HRCT chest scans without any positive <br/ ><br> imaging findings <br/ ><br>2. Scans of suboptimal quality. <br/ ><br>3. Scans not analyzed by AI algorithm.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To find out the accuracy of the Automated quantification of HRCT patterns that are associated with COVID-19 as compared with the manual analysis of the same.Timepoint: 6 WEEKS→ | | | | Yes | False | | |
| → | CTRI/2021/01/030373 | 27 January 2021 | ETHIC trial: Early LMWH in symptomatic COVID-19 positive patients | Early thromboprophylaxis in COVID-19 (ETHIC trial): an open label, randomized phase IIIb trial of community-based prophylactic low-molecular-weight heparin (LMWH) versus standard of care (no enoxaparin) in COVID-19 positive patients - ETHIC | | Thrombosis Research Institute | 11-01-2021 | 20210111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50288 | Not Recruiting | No | | | | 11-01-2021 | 1370 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3/ Phase 4 | United Kingdom;Spain;South Africa;Russian Federation;Brazil;Belgium;Austria;Australia;India→ | Deepak Kumar→ | | Tech Observer India Pvt Ltd,
1391, 34A, Pandit Vishnu Dutt Marg,
RC Basti,Block WZ,
Nangal Raya, Janakpuri,
New Delhi - 110046
→ | deepak.kumar@tech-observer.com→ | 91-11-45150926→ | Tech Observer India→ | Inclusion criteria: Male or female, age equal or greater than 55 years but no upper age limit <br/ ><br>At least two of the following additional risk factors: <br/ ><br>Age equal or greater than 70 years <br/ ><br>Body mass index > 25 kg/m2 <br/ ><br>Chronic obstructive pulmonary disease (COPD) <br/ ><br>Diabetes <br/ ><br>Cardiovascular disease <br/ ><br>Corticosteroid use <br/ ><br> <br/ ><br>→ | Exclusion criteria: â?¢ Contraindications to unfractionated heparin or LMWH <br/ ><br>â?¢ Recent ( <48 hours) or planned spinal or epidural anesthesia or puncture, PCI or thrombolytic therapy within the preceding 24 hours <br/ ><br>â?¢ Increased risk for bleeding complications (liver disease, recent haemorrhagic stroke, prior major bleeding or predisposition to bleeding, alcohol use) <br/ ><br>â?¢ Pregnant women <br/ ><br>â?¢ Severe renal impairment (GFR < 30 mL/min) <br/ ><br>â?¢ Receiving any antiplatelet therapy (with the exception of low dose (â?¤100mg) aspirin) or anticoagulant therapy (e.g. VKA, DOAC) <br/ ><br>â?¢ Patients participating in an interventional study that is outside the purview of TRI sponsored studies. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Enoxaparin 40mg in pre-filled syringe: Enoxaparin is intended for use as a single-dose subcutaneous injection and participants will either receive enoxaparin 40mg once daily or twice daily (weight dependant, 40 mg once per day if less than 100 kg and<br>40 mg twice per day if equal to or greater than 100 kg). Treatment is for 21 days.<br>Control Intervention1: Standard of care treatment (no enoxaparin): In India, according to â??Clinical Management Protocol: COVID-19 â?? Version 5â?? dated 03.07.20<br>Published by the Government of India, for those in the community (i.e. not hospitalised), standard of care may include symptomatic treatment such as antipyretic (paracetamol) for fever and pain, anti-tussives for cough, adequate nutrition and appropriate hydration. Hydroxychloroquine may also be considered in patients with high risk features. <br><br>→ | â?¢ Death <br/ ><br>All-cause <br/ ><br>Cardiovascular <br/ ><br>Non-Cardiovascular <br/ ><br>Specific causes <br/ ><br>Fatal bleed <br/ ><br>Hospital admission <br/ ><br>Pneumonia <br/ ><br>Acute Respiratory distress syndrome <br/ ><br>Acute medical care or admission to intensive care unit (ICU) <br/ ><br>Mechanical ventilation/ Extracorporeal membrane oxygenation (ECMO) <br/ ><br>Non-invasive ventilation/high flow oxygen <br/ ><br>Hospitalized on supplemental oxygen <br/ ><br>Hospitalized not requiring supplemental oxygen <br/ ><br>Hospitalized not requiring ongoing medical care <br/ ><br>Timepoint: 21 days→ | | | | Yes | False | | |
| → | CTRI/2021/01/030385 | 27 January 2021 | To study whether Remdesivir (an antiviral, used for the treatment of COVID - 19) is effective in COVID 19 patients with respect to complications of the disease or death. | To Study the impact of Remdesivir on complications and mortality of COVID 19 patients admitted in tertiary care hospital | | Kasturba Medical College Manipal | 11-01-2021 | 20210111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51172 | Not Recruiting | No | | | | 20-01-2021 | 1066 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sneha S→ | | Department of Medicine, Kasturba Medical College, MAHE, Manipal, Udupi district - 576104 → | sneha.s@manipal.edu→ | 9741970110→ | Kasturba Medical College, MAHE, Manipal→ | Inclusion criteria: 1. All patient admitted in Kasturba Hospital, Manipal with COVID-19 positive by RTPCR / RAT between April 2020 and October 2020 <br/ ><br>2. All patient categorized as moderate or severe COVID as per standard guidelines.→ | Exclusion criteria: 1. Patients who have sepsis from other sources <br/ ><br>2. Patients with underlying lung disease like COPD, ILD, destroyed lung which may contribute to their hypoxia . <br/ ><br>3. Patients with malignancy and other causes of immune suppression. <br/ ><br>4. Patients who are pregnant.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | The impact of remdesivir on outcomes in these patients will be analyzedTimepoint: On admission, during the hospital stay till discharge of the patient→ | | | | Yes | False | | |
| → | CTRI/2021/01/030384 | 27 January 2021 | COVID -19 death predictors | Mortality predictors in patients with COVID -19 in a tertiary care hospital in south India | | Dr ADARSHA G K | 11-01-2021 | 20210111 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50170 | Not Recruiting | No | | | | 20-01-2021 | 1071 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr ADARSHA G K→ | | Department of Medicine , Kasturba Medical College
Manipal Department of Medicine
Kasturba Medical College , Manipal-576104→ | adarsha.gk@manipal.edu→ | 9591706468→ | Kasturba Medical College, Manipal→ | Inclusion criteria: Both male and female subjects aged 18 years and above who were tested positive for COVID -19 by RT-PCR or Rapid antigen test and admitted to KMC Manipal between period of 01/07/2020 to 30/09/2020 for treatment will be included in the study→ | Exclusion criteria: Patient aged less than 18 years are excluded→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Survival following COVID-19 infection against Non survivalTimepoint: At baseline ( at the time of admission to hospital )→ | | | | Yes | False | | |
| → | CTRI/2021/01/030416 | 27 January 2021 | Novel Corona Virus-2019-nCov vaccine by intradermal route in
healthy subjects. | A phase III, randomized, multi-centre, double blind, placebo
controlled, study to evaluate efficacy, safety and immunogenicity
of Novel Corona Virus -2019-nCov vaccine candidate of M/s
Cadila Healthcare Limited. - ZyCoV-D | | Cadila Healthcare Ltd | 12-01-2021 | 20210112 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51254 | Recruiting | No | | | | 20-01-2021 | 28216 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3 | India→ | Dr Ravindra Mittal→ | | Zydus Corporate Park, Scheme No. 63, Survey No. 536, Nr. Vaishnodevi Circle, S.G. Highway. → | kevinkumarkansagra@zyduscadila.com→ | 02717665555→ | Cadila Healthcare Limited→ | Inclusion criteria: 1.Healthy subject of either gender â?¥12 years of age. <br/ ><br>2. Agrees not to take any COVID-19 licensed vaccination for the entire duration of the study. <br/ ><br>3. Ability to provide informed consent from the adult subjects or from the parents of paediatric <br/ ><br>subjects. Additionally, assent from paediatric subjects (Audio video recording in case of <br/ ><br>vulnerable subject). <br/ ><br>4. Adult subjects or parents of paediatric subjects literate enough to fill the diary card. <br/ ><br>5. Subjects with good health or with stable medical condition for chronic disease. (Stable <br/ ><br>condition is defined as there is no change in the medication or dose of medication or severity <br/ ><br>of disease from last 3 months before enrolment.) <br/ ><br>6. Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical <br/ ><br>sterilization), from screening until completion of the follow-up visit and males will agree to <br/ ><br>use contraception. <br/ ><br>7. Willing to allow storage and future use of biological samples for future research. <br/ ><br>→ | Exclusion criteria: 1.Febrile illness (temperature â?¥ 38°C or 100.4°F) or any acute illness or infection within 4 <br/ ><br>weeks of enrolment. <br/ ><br>2. Laboratory confirmed SARS-CoV-2 positive. <br/ ><br>3. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days. <br/ ><br>4. History of SARS/ MERS infection. <br/ ><br>5. Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine. <br/ ><br>6. Past history of hypersensitivity reaction or any serious adverse event after any vaccination. <br/ ><br>7. Past history of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation <br/ ><br>therapy. <br/ ><br>8. Subjects with confirmed immunosuppressive or immunodeficiency disorder; or subjects on <br/ ><br>any immunosuppressive or immunostimulant therapy. <br/ ><br>9. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, <br/ ><br>gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological <br/ ><br>disorder. <br/ ><br>10. Subjects administered blood, blood containing products or immunoglobulins within the last <br/ ><br>3 months or planned administration during the study. <br/ ><br>11. Any other vaccine administration within the last 30 days or planned to be administered <br/ ><br>during the study period. <br/ ><br>12. Pregnant and lactating women. <br/ ><br>13. Participation in another clinical trial in the past 3 months. <br/ ><br>14. History of drug / alcohol abuse.→ | | Intervention1: Novel Corona Virus-2019-nCov Vaccine: (1)Dose:-0.2 ml (0.1ml in eacharms) with Pharmacjet <br>(2)Site of administration:- Upper Arm<br>(3)Frequency:-single time at day 0 day 28 and day 56.<br>(4)Route:-Intradermal<br>Control Intervention1: Placebo: 1)Dose:-0.2 ml (0.1ml in eacharms) with Pharmacjet (2)Site of administration:- Upper Arm (3)Frequency:-single time at day 0 day 28 and day 56. (4)Route:-Intradermal<br>→ | To demonstrate the efficacy of ZyCoV-D in the prevention of virologically confirmed symptomatic COVID-19 cases as compared to placebo.Timepoint: Day 70 to Day 364→ | | | | Yes | False | | |
| → | CTRI/2021/01/030414 | 27 January 2021 | Healthcare workers reflections on COVID 19 pandemic | Reflections of COVID-19 Health Care Workers: a qualitative study | | Pramukhswami Medical College | 12-01-2021 | 20210112 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51377 | Not Recruiting | No | | | | 21-01-2021 | 30 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Bhalendu Vaishnav→ | | Department of Medicine
Pramukhswami Medical College, Shree Krishna Hospital
Karamsad → | bhalendusv@charutarhealth.org→ | 9825717481→ | Pramukhswami Medical College→ | Inclusion criteria: Healthcare workers (residents and faculty members) who have completed at least one posting COVID wards and willing to give consent→ | Exclusion criteria: None→ | | | Allow recording and analysis of reflections of healthcare workers engaged in care of COVID patientsTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/01/030433 | 27 January 2021 | A retrospective analysis to study the Effectiveness and Safety profile of Remdesivir therapy in patients who diagnosed with COVID-19 | Efficacy and Safety of Remdesivir in COVID-19: A retrospective analysis | | Dr Vishal Shanbhag | 13-01-2021 | 20210113 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49676 | Not Recruiting | No | | | | 18-01-2021 | 1050 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Girish Thunga→ | | Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, Manipal Academy of Higher Education → | vishal.shanbhag@manipal.edu→ | 9901960496→ | Kasturba Medical College→ | Inclusion criteria: All adults patients diagnosed with laboratory-confirmed SARS-CoV-2 infection from March 2020 to September 2020 in Kasturba Hospital Manipal irrespective of gender will be included→ | Exclusion criteria: Pediatric population→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Mortality rate/death, Reversal of COVID-19/recovery, Duration of ICU or ventilation and/or Hospital stay, Negative RT-PCR, Improvement in Chest CT, Radiological parameters by CXR Brixia Score, and Lung Zone wise Brixia Score distributionTimepoint: The outcomes will be measured at baseline, at 24 hours, 48 hours, 72 hours, and 5days post administration of remdesivir→ | | | | Yes | False | | |
| → | CTRI/2021/01/030432 | 27 January 2021 | Importance of blood investigations in assessing severity and recovery in Covid 19 patients | Laboratory variables and outcome measures of Covid 19 in patients: A data based retrospective study from Udupi district | | Manipal Academy of Higher Education | 13-01-2021 | 20210113 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51518 | Not Recruiting | No | | | | 15-02-2021 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Vijetha Shenoy Belle→ | | Department of BiochemistryKasturba Medical College Madhav Nagar → | vijetha.shenoy@manipal.edu→ | 09844667820→ | Kasturba Medical College Manipal→ | Inclusion criteria: All adult patients with confirmed Covid 19 infection admitted (30/05/2020 to 30/08/2020) to Kasturba Hospital, Manipal, Manipal Academy of Higher Education, Manipal can be enrolled in the study→ | Exclusion criteria: Any patient without confirmed Covid 19 or any patient with non Covid SARI→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | 1) Duration of hospital stay/ time to discharge <br/ ><br>2) Mortality <br/ ><br>3) Development of secondary severe complications like pulmonary embolism, MI, cardiac arrest etc <br/ ><br> <br/ ><br>Timepoint: At admission and discharge of each patient→ | | | | Yes | False | | |
| → | CTRI/2021/01/030430 | 27 January 2021 | Questionnaire based study to assess physical and mental health status of health care workers who have recovered from COVID-19 | Battle after the initial victory â?? A questionnaire-based study to assess health, social and psychological status among health care workers after recovery from COVID-19 and the change in demeanor. | | Shwethapriya Rao | 13-01-2021 | 20210113 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51547 | Not Recruiting | No | | | | 25-01-2021 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shwethapriya Rao→ | | Department of Critical Care
Kasturba Medical College, Manipal → | shwethapriya.rao@manipal.edu→ | | Kasturba Medical College→ | Inclusion criteria: All health care workers who have recovered from COVID-19 will be included in the study, and who are willing to participate in the questionnaire study→ | Exclusion criteria: Any health care worker who has recovered from COVID-19 but not willing to participate in the study.→ | | | It is a questionnaire study with closed ended multiple options. So the outcomes will be as per answers in the questionnaire study.Timepoint: 31.03.2021; that is 3 months after IEC approval→ | | | | Yes | False | | |
| → | CTRI/2021/01/030431 | 27 January 2021 | Relation of Oxygen saturation, respiratory rate ratios with failure of high flow oxygen therapy in Corona patients | Relationship of ROX and Modified ROX index with High Flow Nasal Cannula oxygen therapy in COVID 19 patients: An observational pilot study | | All India Institute of Medical Sciences Raipur | 13-01-2021 | 20210113 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51381 | Not Recruiting | No | | | | 29-01-2021 | 30 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Habib Md Reazaul Karim→ | | Faculty Room A001, Block A, AIIMS Hospital Complex, Tatibandh → | drhabibkarim@gmail.com→ | 9612372585→ | All India Institute of Medical Sciences, Raipur→ | Inclusion criteria: 1. On HFNO therapy <br/ ><br>2. admitted to ICU / HDU with continuous SpO2 and RR monitoring <br/ ><br>→ | Exclusion criteria: 1. Pre-existing respiratory disease: COPD, Bronchial Asthma, idiopathic pulmonary fibrosis→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | Failure of HFNO (if any)Timepoint: baseline, 12h, 24h, 36h, 48h, 60h, 72h, 84h, 96h, 108h, 120h, or at failure point→ | | | | Yes | False | | |
| → | CTRI/2021/01/030454 | 27 January 2021 | Clinical study on Zandu Chyavanprash as a preventive remedy in pandemic of Covid-19. | Clinical evaluation of Zandu Chyavanprash as an immunity booster for its preventive effect on infections in pandemic of COVID-19 â?? An open label, Multi centric, Randomized, Comparative, Prospective, Interventional Community based Clinical Study on Healthy individuals - NIL | | Emami Ltd | 14-01-2021 | 20210114 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51491 | Not Recruiting | No | | | | 22-01-2021 | 300 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Sanjay Tamoli→ | | Target Institute of Medical Education and Research
Department of Medical Services, 4th Floor, A wing, 402-A,B,C, Jaswanti Allied business center Kachpada, Malad west, Mumbai → | targetinstitute@yahoo.com→ | 9322522252→ | Target Institute of Medical Education and Research→ | Inclusion criteria: 1. Healthy individuals will be considered as those who do not have any acute medical condition or chronic medical or surgical condition that requires either immediate or continuous medical monitoring or treatment. <br/ ><br>2. Subjects tested Negative for total antibodies for COVID-19 <br/ ><br>3. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study. <br/ ><br>→ | Exclusion criteria: 1.Pregnant and Lactating females <br/ ><br>2. Subjects who have been confirmed of having COVID-19 and have been isolated for its treatment. Subjects having recently suffered and recovered of COVID-19 will also be excluded from the study <br/ ><br>3. Known cases of Diabetes <br/ ><br>4. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>4. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. <br/ ><br>5. Subjects taking steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Subjects participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study. <br/ ><br>7. Subjects having a past history of allergy to Chyawanprash like products <br/ ><br>8. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol <br/ ><br>→ | | Intervention1: Zandu Chyavanprash and Milk: Zandu Chyavanprash contains Bilva, Agnimantha, Syonaka, Patala, Gambhari, Shalaprani, Prishniparni , Brihati, Kantakari, Gokshura, Bala, Mudgaparni, Mashaparni, Karkatshringi, Tamalaki, Draksha , Jivanti, Pushkara Haritaki ,Guduchi, Vidari, Musta , Rakta Punarnava, Vasa, Kakanasika, Pippali, Sukshmaila, Riddhi &Vriddh, Meda & Mahamedha, Jivaka & Rishabhak, Kakoli & Kshir kakoli. Powder of the Following: Pippali , Vanshalochana, Tvak, Tvakpatra, Sukshmaila, Nagakesara , Amalaki, Til tail, Ghrita, Guda, Honey along with preservatives and excipients<br><br>Dosage and Treatment Duration:Subjects will be given Zandu Chyavanprash in a dose of one teaspoonful approx.12 gm) twice daily followed by a cup of milk (Approx. 200 ml).<br><br>Control Intervention1: Milk: Milk<br><br><br>Dosage and Treatment Duration: <br>Subjects will be asked to take a cup of milk twice daily (Approx. 200 ml) and will not be given any intervention<br><br>→ | 1. Change in incidence of COVID-19 [by RT- PCR and or total antibody fo r[COVID-19] in subjects taking Zandu Chyavanprash and those not taking it <br/ ><br>2. Change in incidence of other non COVID-19 infections in subjects taking Zandu Chyavanprash and those not taking itTimepoint: Screening visit (day -5), baseline visit (day 0), day 15, day 30, day 45, day 60, day 75 and day 90.→ | | | | Yes | False | | |
| → | CTRI/2021/01/030451 | 27 January 2021 | A study done to find out anxiety in patients admitted in icu requiring Non invasive ventilation | Correlation between Anxiety Scoring and Compliance to Non invasive ventilation in Patients requiring Non invasive Ventilation admitted in COVID ICU | | SRM Institute of science and technology | 14-01-2021 | 20210114 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49457 | Not Recruiting | No | | | | 23-01-2021 | 39 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Participant Blinded | N/A | India→ | B Gayathri→ | | ROOM NO.209,SECOND FLOOR
Department of Anaesthesia
SRM Medical College Hospital
Potheri → | keerthivasanm94@gmail.com→ | 9444304482→ | SRM Medical College Hospital→ | Inclusion criteria: Patient diagnosed covid19 positive <br/ ><br>Patients requiring Non invasive ventilation admitted in COVID ICU→ | Exclusion criteria: Patients tested negative for COVID RTPCR <br/ ><br>Patients who are intubated <br/ ><br>Patients not on Non invasive ventilation <br/ ><br>→ | Health Condition 1: J960- Acute respiratory failure
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: nil: nil<br>→ | Patients with higher anxiety will be having reduced compliance to NIV mask ventilationTimepoint: DAY 0,DAY 4,Day 7,Day 10→ | | | | Yes | False | | |
| → | CTRI/2021/01/030477 | 27 January 2021 | Study to find out whether immunosuppressant Mycophenolate Sodium is effective in the treatment of Covid 19 infection. | Study to Evaluate the Efficacy of Mycophenolate Sodium in Covid 19 Infection. | | Shri Janai Research Foundation | 14-01-2021 | 20210114 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48197 | Not Recruiting | No | | | | 19-01-2021 | 100 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Atul Sajgure→ | | Room no 120,
Department of Medicine,
Sahyadri Speciality Hospital
Plot 30 C, Karve Road,
Erandwane, Pune 411004 → | atulsajgure@yahoo.com→ | 9890676278→ | Sahyadri Speciality Hospital→ | Inclusion criteria: 1. Subjects with active COVID â?? 19 infection. <br/ ><br>2. Age more than 18 years. <br/ ><br>3. Actual or estimated weight more than 50kg. <br/ ><br>4. Mild to moderate infection. <br/ ><br>5. Subjects willing to give consent for participation in the study. <br/ ><br>6. No clinical contraindications for Mycophenolate administration. <br/ ><br>→ | Exclusion criteria: 1. Age less than 18 years. <br/ ><br>2. Subjects not willing to give consent for participation in the study. <br/ ><br>3. Subjects having pancytopenia. <br/ ><br>4. Subjects with secondary bacterial sepsis. <br/ ><br>5. Subjects already taking immunosuppressive medications for other conditions. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: R688- Other general symptoms and signs
→ | Intervention1: MYCOPHENOLATE SODIUM: Subjects with Covid 19 infection participating in the study will receive Mycophenolate Sodium for a period of 1 month from the diagnosis in addition to the standard of care.<br>Intervention2: MYCOPHENOLATE SODIUM: Subjects with Covid 19 infection participating in the study will receive Mycophenolate Sodium for a period of 1 month from the diagnosis in addition to the standard of care.<br>Intervention3: MYCOPHENOLATE SODIUM: Formulation: 360mg capsule.<br>Dose: one capsule everyday.<br>Route of administration: oral.<br>Duration: 1 month<br><br>Control Intervention1: NIL: NIL<br>→ | To assess the effect of Mycophenolate on mortality due to COVID-19 infection.Timepoint: 30 days→ | | | | Yes | False | | |
| → | CTRI/2021/01/030455 | 27 January 2021 | Prevalence of COVID19 antibodies among blood donors. | Seroprevalence of SARS-CoV2 Specific IgG Antibodies Among Blood Donors | | Nivetha M | 14-01-2021 | 20210114 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51086 | Not Recruiting | No | | | | 01-02-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Nivetha M→ | | Department Of Immunohematology And Blood Transfusion,
Sri Ramachandra Institute Of Higher Education And Research(Deemed to be University),
Porur,
Chennai.
→ | rrkm05@gmail.com→ | 9840417591→ | Sri Ramachandra institute of higher education and research.→ | Inclusion criteria: All healthy eligible blood donors who are willing to Participate in the study→ | Exclusion criteria: Blood Donors who are not willing to participate in the study.→ | | Control Intervention1: NIL: NIL<br>→ | Estimating the prevalence of asymptomatic Covid 19 infections among blood donorsTimepoint: 1 year→ | | | | Yes | False | | |
| → | CTRI/2021/01/030456 | 27 January 2021 | Exploring experiences of ethics committee members during COVID-19 pandemic | A survey on the strategies adopted by ethics committee in India during the COVID-19 period in order to review, regulate and approve projects | | Department of Physiotherapy MCHP MAHE Manipal | 14-01-2021 | 20210114 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51410 | Not Recruiting | No | | | | 01-02-2021 | 383 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Rajeshkrishna Bhandary P→ | | Department of Psychiatry, KMC, Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka, India. → | rajesh.kbp@manipal.edu→ | 9844542567→ | Katurba Medical College→ | Inclusion criteria: The members must be serving in an ethics committee in India→ | Exclusion criteria: None→ | | Intervention1: NA: NA<br>→ | A validated survey questionnaire will be usedTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2021/01/030485 | 27 January 2021 | THE EFFECT OF THE COVID-19 PANDEMIC ON HOSPITAL VISITS OF PATIENTS PRESENTING WITH CHEST PAIN TO THE EMERGENCY DEPARTMENT | THE IMPACT OF THE COVID-19 PANDEMIC ON HOSPITAL VISITS OF PATIENTS PRESENTING WITH CHEST PAIN: AN EMERGENCY DEPARTMENT PERSPECTIVE | | JSS Academy of Higher Education and Research | 15-01-2021 | 20210115 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51385 | Not Recruiting | No | | | | 30-01-2021 | 1000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Madhu Srinivasarangan→ | | Department of Emergency Medicine
JSS Hospital
M.G. Road,
Agrahara → | madhu@jssuni.edu.in→ | 9449813976→ | JSS Academy of Higher Education and Research→ | Inclusion criteria: All patients presenting to emergency medicine department with <br/ ><br>1.Age >18 years <br/ ><br>2.Patients with the chief complaint of chest pain. <br/ ><br>→ | Exclusion criteria: Exclusion criteria: <br/ ><br>1.History of Trauma immediately preceding the onset of chest pain. <br/ ><br>2.Patients unwilling to participate in the study <br/ ><br>→ | Health Condition 1: I22- Subsequent ST elevation (STEMI) and non-ST elevation (NSTEMI) myocardial infarction
→ | | To assess the change in the number and profile of patients presenting to the Emergency Department with chest pain compared to the numbers prior to the COVID-19 pandemicTimepoint: January 1st 2018 to December 31st 2020→ | | | | Yes | False | | |
| → | CTRI/2021/01/030488 | 27 January 2021 | Healthcare access and quality of life of persons with disabilities during COVID-19 | Healthcare access and Quality of Life (QOL) during COVID-19 among persons with disabilities (PwDs) â?? An exploratory sequential mixed methods study in Udupi district, Karnataka | | Varalakshmi Chandra Sekaran | 15-01-2021 | 20210115 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51403 | Not Recruiting | No | | | | 25-01-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Varalakshmi Chandra Sekaran→ | | Department of Community Medicine
Melaka Manipal Medical College (Manipal Campus)
MAHE, Manipal
Karnataka → | varalakshmi.cs@manipal.edu→ | 9535810325→ | Melaka Manipal Medical College (Manipal Campus)→ | Inclusion criteria: Male and female PwDs (RPwDs Act 2016) aged 18 years and above with blindness, low vision, leprosy cured persons, locomotor disability, dwarfism, specific learning disabilities, speech and language disability, acid attack victims, thalassemia, hemophilia and sickle cell disease who consent to participate will be included in the study.→ | Exclusion criteria: PwDs with hearing impairment, intellectual disability, mental illness, ASD, cerebral palsy, muscular dystrophy, chronic neurologic conditions, multiple sclerosis, multiple disabilities including deaf-blindness, Parkinsonâ??s disease and those who may not be able to provide telephonic interviews will be excluded from the study.→ | | Intervention1: Nil: Nil<br>→ | Challenges to accessing healthcare among PwDs with various disabilities and their specific needs will be identified.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/01/030522 | 27 January 2021 | COVID and dental treatment | Knowledge and apprehension of Dental Patients receiving dental treatment about COVID 19: A questionnaire study. | | anand deep shukla | 18-01-2021 | 20210118 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51566 | Not Recruiting | No | | | | 28-02-2021 | 400 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Anand deep Shukla→ | | Department of Oral Surgery ,
MCODS , Manipal Manipal college of dental sciences , Manipal
576104→ | drandymanipal@gmail.com→ | 9742354052→ | MCODS, Manipal→ | Inclusion criteria: 1) Patients visiting dental OPD for dental procedures <br/ ><br>2) Patients above 18 years of age <br/ ><br>3) Patients who are able to read and write English or kannada <br/ ><br>→ | Exclusion criteria: 1) Patients below 18 years of age <br/ ><br>2) Patients who are unable to read English or Kannada <br/ ><br>→ | Health Condition 1: K088- Other specified disorders of teethand supporting structures
→ | | To assess the knowledge about COVID 19 amongst dental patients . <br/ ><br> 2) To assess what apprehensions patients have when they visit a dental clinic during these times . <br/ ><br>Timepoint: 6 months : After the study is complete the data would be analysed statistically <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/01/030529 | 27 January 2021 | â?? Ayurvedic intervention in the management of COVID-19 positive childrenâ?? | â??A clinical trial to establish effectiveness of Ayurvedic intervention in the management of COVID-19 positive children - A single arm studyâ?? | | Ch Brahm Prakash Ayurved Charak Sansthan | 18-01-2021 | 20210118 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51315 | Not Recruiting | No | | | | 18-01-2021 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Jitesh Verma→ | | Ch. Brahm Prakash Ayurved Charak Sansthan, Khera dabar, Najafgarh, New Delhi-73 → | bharatbhoyar@gmail.com→ | 9891954426→ | Ch. Brahm Prakash Ayurved Charak Sansthan→ | Inclusion criteria: 1. Willingness to participate in the study and provide the informed consent. <br/ ><br>2. Cases tested positive for SARS-CoV2 virus that are either asymptomatic or with mild to moderate category symptoms; hospitalized in CHC, CBPACS, New Delhi / self-isolated. <br/ ><br>3. Cases between age group 5 year to 16 years of either gender. <br/ ><br>→ | Exclusion criteria: 1. Cases presenting with severe symptoms of COVID-19. <br/ ><br>2. COVID-19 positive cases participating as subjects in the interventional arm of other COVID-19 clinical trials. <br/ ><br>3. Any other condition, which as per the investigator would jeopardize the outcome of the trial. <br/ ><br>→ | Health Condition 1: B342- Coronavirus infection, unspecified
Health Condition 2: B342- Coronavirus infection, unspecified
Health Condition 3: R070- Pain in throat
Health Condition 4: R070- Pain in throat
→ | Intervention1: 1. Balchaturbhadrika Churna<br>2. Laghu Malini Basant Rasa: 1.Balchaturbhadrika Churna- orally twice daily after meals with honey in a dose according to age ( 5-8 yrs:625 mg, 8-12 yrs:875mg, more than 12 yrs: 1 gm)<br>2. Laghu Malini Basant Rasa- orally twice daily after meals with honey in a dose according to age ( 5-8 yrs:62.5 mg, 8-12 yrs:125 mg, more than 12 yrs: 250 mg)<br>Control Intervention1: Not applicable: Not applicable<br>→ | 1. Time taken to convert from symptomatic to asymptomatic condition <br/ ><br>2. Time taken to negative conversion of rtPCR <br/ ><br>Timepoint: 1.Baseline <br/ ><br>2.10th day <br/ ><br>3.15th day if rtPCR positive on 10th day <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/01/030520 | 27 January 2021 | Monitoring the trend of SARS-CoV-2, Dengue and Chikungunya infection transmission in the general population, India | Establish serial sero-surveillance to monitor the trend of SARS-CoV-2, Dengue and Chikungunya infection transmission in the general population, India | | Dr Guru Rajesh Jammy | 18-01-2021 | 20210118 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49067 | Not Recruiting | No | | | | 01-02-2021 | 25000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Guru Rajesh Jammy→ | | Department of Public Health,
Epidemiology Division,
Room No.3
SHARE INDIA
MediCiti Institute of Medical Sciences Campus,
Medchal-Malkajgiri(Dist),
Medchal(Mandal)
Telangana, Hyderabad. INDIA.
SHARE INDIA
MediCiti Institute of Medical Sciences Campus,→ | jammyrajesh@sharefoundations.org→ | 9989924783→ | SHARE INDIA (Society for Health Allied Research and Education,INDIA)→ | Inclusion criteria: Survey will be carried out in individuals above 2 years of age and all individuals currently residing and likely to stay till the end of study (1 year) in the study area will be considered eligible for inclusion.→ | Exclusion criteria: Not Applicable→ | | | I.Estimate the sero-prevalence of SARS-CoV-2 infection in the general population <br/ ><br>II. Estimate the 4 monthly incidence of SARS-CoV-2 infection based on serial sero-surveys <br/ ><br>III. Estimate cumulative sero-conversion of SARS-CoV-2 infection over one year period <br/ ><br>IV. Estimate the sero-prevalence and annual sero conversion of Dengue and Chikungunya in a sub sample of the study <br/ ><br>Timepoint: I.At the end of One year <br/ ><br>II.At four months interval for one year <br/ ><br>III. At the end of one year <br/ ><br>IV.At the end of one year→ | | | | Yes | False | | |
| → | CTRI/2021/01/030534 | 27 January 2021 | Study of ENT Manifestations of COVID-19 | ENT Manifestations oF COVID-19 In a dedicated COVID Hospital: An Observational Study | | Dr Anuja Santosh Kulkarni | 18-01-2021 | 20210118 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51122 | Not Recruiting | No | | | | 30-01-2021 | 273 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Merlin Babu→ | | ENT Department, Jagjivan Ram Railway Hospital, Mumbai central, Mumbai → | dr.anujakulkarni@gmail.com→ | 9819464115→ | Jagjivan Ram Railway Hospital→ | Inclusion criteria: Laboratory confirmed COVID-19 positive patients admitted in Jagjivan Ram Hospital, aged >(more than) 18 years and â?¤(less than or equal to) 99 years irrespective of gender and comorbidities→ | Exclusion criteria: 1)Children <(less than) 18 years old <br/ ><br> <br/ ><br>2)Pregnant women <br/ ><br> <br/ ><br>3)Those who are not able to communicate and intubated patients <br/ ><br> <br/ ><br>4)Unconscious patients, mentally challenged patients. <br/ ><br> <br/ ><br>5)Previous History of chronic ENT problems and recent head injury. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1)Length of time for alleviation of symptoms pertaining to ENT manifestations <br/ ><br>2)Length of time to Normalisation of respiratory rate, oxygen saturation, alleviation of cough <br/ ><br>3)Duration of hospitalisation <br/ ><br>4)Length of time of normalisation of oxygen saturationTimepoint: at Time points: on day 1, 3, 7 and optionally on day 14, 21 and 28 if the patient remains hospitalized and if symptoms persist after one week, wherever feasible and applicable→ | | | | Yes | False | | |
| → | CTRI/2021/01/030533 | 27 January 2021 | Sildenafil Use in Covid-19 Patients - A Pilot Study | Sildenafil Use in Covid-19 Patients - A Pilot Study | | Sardar Vallabh Bhai Patel Covid Hospital | 18-01-2021 | 20210118 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51393 | Not Recruiting | No | | | | 25-01-2021 | 25 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Saajan Joshi→ | | Department of Anesthesiology and Critical Care,
Command Hospital Eastern Command,
Alipore Road,
Kolkata → | joe21sf@gmail.com→ | 9599699348→ | Sardar Vallabh Bhai Patel Covid Hospital, Ulan Bater Road, Delhi Cantt, New Delhi→ | Inclusion criteria: 1. Established case of Covid-19 (RTPCR +ve) <br/ ><br>2. Moderate Covid-19 patients (SpO2 90 â?? 94% on room air, RR 24 â?? 30/min) with visible radiographic features of pneumonia <br/ ><br>3. Severe Covid-19 patients (SpO2 < 90% on room air, RR >30/min) with visible radiographic features of pneumonia <br/ ><br>→ | Exclusion criteria: 1. Pregnant and lactating women <br/ ><br>2. Patients on Nitrate medications in any form <br/ ><br>3. Patients with any malignant tumor <br/ ><br>4. Patients with heart ailments including Myocardial Infarction (in < 6 months) or heart failure. <br/ ><br>5. Patients with mental illness or stroke ( < 6months) <br/ ><br>6. Advanced liver or kidney ailment <br/ ><br>7. Patients with known history of severe systemic hypertension especially if uncontrolled <br/ ><br>8. Patients with systemic hypotension because of any reason. <br/ ><br>9. Patients allergic to Sildenafil <br/ ><br>10. Patients already on mechanical ventilation <br/ ><br>11. Patients with inability to take drug orally or inability to place Ryleâ??s tube. <br/ ><br> <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ENTERAL SILDENAFIL: Tablet Sildenafil will be administered orally or through nasogastric tube, thrice a day, in moderate and severe Covid-19 patients<br>Intervention2: Tablet Sildenafil: Tablet Sildenafil will be administered orally or through nasogastric tube, thrice a day in the maximum dose of 0.1 grams/day. It will be commenced in the dose of 20 mg BD and would be gradually increased to 30 mg tds in 3-4 days, keeping in view hemodynamic stability.<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | To observe Sildenafil effect on Covid-19 progression including clinical findings, oxygenation and radiological findingsTimepoint: Three weeks or hospital discharge or death whichever is first→ | | | | Yes | False | | |
| → | CTRI/2021/01/030546 | 27 January 2021 | Acceptance of COVID-19 vaccine among Bangladeshi general population | COVID-19 Vaccination Hesitancy in Bangladesh: A Rapid National Assessment | | Uttara Adhuni Medical College and Hospital | 18-01-2021 | 20210118 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51674 | | No | | | | 26-01-2021 | 10000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Bangladesh→ | Mohammad Ali→ | | Department of Physitherapy and Rehabilitation, Room no-01, House-34, Road-04, Sector-09, Uttara, Dhaka, Bangladesh. → | m180002@student.bup.edu.bd→ | 88-01715043533→ | Uttara Adhunik Medical College and Hospital→ | Inclusion criteria: Bangladeshi citizen currently live in Bangladesh and Age 18 years and above→ | Exclusion criteria: Not currently live in Bangladesh→ | | | Agreement or disagreement regarding COVID-19 vaccinationTimepoint: At baseline→ | | | | Yes | False | | |
| → | CTRI/2021/01/030573 | 27 January 2021 | A study to understand post COVID quality of life | Post Hospital Discharge follow-up of Health-Related Quality of Life (HRQOL) of COVID-19 infected patients. (COVID QOL India) - MIER/COVID/QOL/India/001 | | Medanta Institute of Education and Research | 19-01-2021 | 20210119 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51269 | Not Recruiting | No | | | | 22-01-2021 | 5000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Pooja Sharma→ | | 10th Floor Department Medanta Institute of Education and Research Division Clinical Research Medanta The Medicity Sector 38 Near Baktawar Chowk Gurgaon Haryana→ | vikas.deswal@medanta.org→ | 9992837902→ | Medanta The Medicity Gurugram Haryana India→ | Inclusion criteria: Discharged from Medanta-The Medicity hospital after hospitalization for COVID-19 infection <br/ ><br> <br/ ><br>Given consent for subsequent use of his/her personal health data for research purpose→ | Exclusion criteria: Contact details not available or incorrect <br/ ><br> <br/ ><br>Readmission due to COVID infection→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | To determine the post recovery complications in COVID-19 Patients <br/ ><br> <br/ ><br>To determine the clinically significant drop in Quality-of-Life post recovery from COVID-19 infection <br/ ><br> <br/ ><br>To compare the QOL compared by the severity of the initial diseaseTimepoint: 2 months for taking follow up <br/ ><br> <br/ ><br>1 month for statistical analysis and writing manuscript for publication→ | | | | Yes | False | | |
| → | CTRI/2021/01/030582 | 27 January 2021 | A Real World Evaluation of safety, immunogenicity and efficacy of COVID-19 Vaccines among health care workers | A real world study to evaluate the safety, immunogenicity and efficacy of COVID 19 vaccines during the national vaccination roll out among health care workers in a tertiary care hospital | | Medanta Institute of Education and Research | 19-01-2021 | 20210119 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51278 | Not Recruiting | No | | | | 23-01-2021 | 5000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Pooja Sharma→ | | Medanta The Medicity Department Clinical Research Medanta Institute of Education and Research Division Clinical Research Sector 38 Gurgaon Haryana→ | vikasdeswal1986@gmail.com→ | 0124-4141414→ | Medanta The Medicity→ | Inclusion criteria: All adults above 18 years of age who are working at Medanta The Medicity Gurgaon and are listed in the first COVID 19 vaccination list shared by Medanta HR Team with the GOI Officials will be considered for participation <br/ ><br>→ | Exclusion criteria: Participation in COVID-19 prophylactic drug trials before or during the duration study <br/ ><br> <br/ ><br>Receipt of any vaccine (licensed or investigational) other than the study intervention within 14 days before and after each study vaccination <br/ ><br> <br/ ><br>History of allergic disease or reactions likely to be exacerbated by any component of <br/ ><br>COVISHIELD <br/ ><br> <br/ ><br>Active ongoing laboratory confirmed COVID 19 <br/ ><br> <br/ ><br>Administration of immunoglobulins and/or convalescent plasma within the three months <br/ ><br>preceding the planned administration of the vaccine→ | | Intervention1: Nil: Nil<br>→ | To assess the safety of the vaccines by actively reported AE/SAE in the first week of vaccination after each dose of the vaccine (Adverse Event Following Immunization) <br/ ><br> <br/ ><br>To assess the safety of the vaccines by passively reported Adverse Vaccine reactions, Vaccine <br/ ><br>associated Adverse Events of Special Interest (AESI) ,such as Vaccine Associated Enhanced Respiratory Disease (ERD)Timepoint: 06 months→ | | | | Yes | False | | |
| → | CTRI/2021/01/030603 | 27 January 2021 | Explore the problems encountered by Physiotherapists during COVID-19 pandemic | A survey on the challenges encountered and resilience strategies adopted by Physiotherapy professionals in India during the COVID-19 pandemic | | Kavitha Vishal | 20-01-2021 | 20210120 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51728 | Not Recruiting | No | | | | 31-01-2021 | 372 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sidhiprada Mohapatra→ | | Manipal Academy of Higher Education, Madhav Nagar, Manipal, Udupi, Karnataka, India → | kavitha.vishal@manipal.edu→ | 9986526077→ | Manipal College of Health Professions, Manipal Academy of Higher Education→ | Inclusion criteria: Physiotherapists involved in care delivery services in India→ | Exclusion criteria: Physiotherapists who are involved in administration, academics and research without involvement in clinical services during the COVID 19 pandemic in India will be excluded.→ | | Intervention1: NA: NA<br>→ | A validated survey questionnaireTimepoint: Baseline: The survey will be a one time administration of a content validated questionnaire→ | | | | Yes | False | | |
| → | CTRI/2021/01/030601 | 27 January 2021 | Cardamom Extract Clinical trial on Covid patients | A Prospective, Open Label, Randomized, Controlled, Pilot Clinical Study To Evaluate The Safety And Efficacy Of Cardamom Extract In Mild To Modrate Covid-19 Adult Patients
| | Zum Heilen Diagnostic Therapeutics ZH DT | 20-01-2021 | 20210120 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50754 | Not Recruiting | No | | | | 20-01-2021 | 30 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | Dr Prashanth→ | | Zum Heilen Diagnostic and Therapeutics , No 143, Bethel Lane Thrissur → | drpvarkey@gmail.com→ | 9249584682→ | Zum Heilen Diagnostic and Therapeutics→ | Inclusion criteria: 1. Subjects aged 18-65 years of age and of either sex <br/ ><br>2. Subjects who are willing to give consent to the study <br/ ><br>3. COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test (RT-PCR). <br/ ><br>4. Mild to Moderate disease (NEWS score Less than/equal to 8) <br/ ><br>5. Can take oral medicines <br/ ><br>6. Subject willing to abide by and comply with the study protocol. <br/ ><br>→ | Exclusion criteria: 1. Age less than 18 years and more than 65 years <br/ ><br>2. Pregnancy and lactation <br/ ><br>3. Severe or complicated course of COVID-19 disease <br/ ><br>4. Presence of acute hypoxic respiratory failure/ need for Intensive care unit (ICU) stay/ Patients who need mechanical ventilation. <br/ ><br>5. Any uncontrolled systemic disease, infection <br/ ><br>6. Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease or any other disorder. <br/ ><br>7. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Cardamom extract: Dose:200 mg <br>Dosage form: Capsule<br>Duration: Day 0 to Day 7 <br>Frequency : 3 times daily orally after meal<br>Control Intervention1: NIL<br>standard of care recommended by GOVt of India: As per the the principal investigator recommendations<br>Control Intervention2: NIL<br>standard of care recommended by GOVt of India: As per the the principal investigator recommendations<br>→ | â?¢ Change in Chest CT severity score (CO-RADS) from baseline to day 7 <br/ ><br>â?¢ Change in Viral load from baseline to day 7 <br/ ><br>â?¢ Change in immune markers (IL-6, LDH, TNF, TLC, ALC, FERRITIN, CRP and D-DIMER) from baseline to day 7 <br/ ><br>Timepoint: Day 0 and Day 7→ | | | | Yes | False | | |
| → | CTRI/2021/01/030630 | 27 January 2021 | A study to identify SARS-CoV-2 in Red Blood Cells in infected patients. | A study to identify SARS-CoV-2 in erythrocytes of patients suffering from COVID-19 at an Apex tertiary care institute in Andhra Pradesh, South India. - 19CoVRBC | | All India Institute of Medical Sciences | 20-01-2021 | 20210120 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47720 | Not Recruiting | No | | | | 02-02-2021 | 10 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Centralized Blinding and masking:Not Applicable | N/A | India→ | Dr I S Chaitanya Kumar→ | | Department of Transfusion Medicine and Hemotherapy, All India Institute of Medical Sciences, Mangalagiri, Guntur District → | ischaitanyakumar@gmail.com→ | 9440106689→ | Faculty at AIIMS, Mangalagiri→ | Inclusion criteria: COVID-19 Positive by RT-PCR→ | Exclusion criteria: 1.Negative for COVID-19 illness <br/ ><br>2.Not willing to participate in the study <br/ ><br>3.Age <18 years or >55 years <br/ ><br>4.Prisoners <br/ ><br>5.Pregnant women <br/ ><br>6.Severely ill patients→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Detection of COVID-19 RNA in RBC/Blood samples during active infectionTimepoint: immediately at enrolment considered Day1→ | | | | Yes | False | | |
| → | CTRI/2021/01/030604 | 27 January 2021 | To understand cardiac and pulmonary function in patients with covid-19 in India | CardiOvaScular and Pulmonary Mechanisms In Covid-19 in India:
A multimodality imaging study
- COSMIC-INDIA study | | Dr Anoop Shah | 20-01-2021 | 20210120 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49046 | Not Recruiting | No | | | | 01-02-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr C Narasimhan→ | | # 136, Plot no 2/3/4/5 Mind space road Gachibowli, Hyderabad
Department of Cardiology and Electrophysiology 1st floor, Cluster-C Room No:3 → | calambur1@gmail.com→ | 9848052409→ | AIG Hospital→ | Inclusion criteria: COVID-19 positive patients <br/ ><br>1-COVID-19 positive <br/ ><br>2-Ideally 2 weeks withina positive test (but can be extended to 4 weeks) <br/ ><br>3-Symptoms suggestive of an acute respiratory viral illness <br/ ><br> <br/ ><br>Positive controls <br/ ><br>1-COVID-19 negative (PCR andserology) <br/ ><br>2-Symptoms suggestive of an acute respiratory viral illness <br/ ><br> <br/ ><br>Negative controls <br/ ><br>1-COVID-19 negative (PCR andserology) <br/ ><br>2-Absence of symptoms of acute respiratory viral illness <br/ ><br>→ | Exclusion criteria: 1-Prior diagnosis of myocardial infarction <br/ ><br>2-Prior diagnosis of a non-ischaemic cardiomyopathy <br/ ><br>3-Patients requiring invasive or non-invasive ventilation <br/ ><br>4-Previous coronary revascularisation or cardiac surgery <br/ ><br>5-Patient inability to undergo CT or CMR scanning, due to severe renal failure (estimated glomerular filtration rate <30 mL/min) or major allergy to iodinated contrast media /gadolinium <br/ ><br>6-Pregnancy or breast feeding <br/ ><br>7-Inability to give informed consent <br/ ><br>8-Contraindication to imaging, example metal fragments in the eye <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | A. Identify the proportion of patients with biochemical evidence of myocardial injury or strain <br/ ><br>i.Presence of elevated cardiac troponin or NTproBNP concentrations <br/ ><br>B. Identify the presence of atherosclerotic disease CTCA <br/ ><br>i.Presence of obstructive coronary artery disease on CTCA 70% <br/ ><br>C.Identify myocardial disease <br/ ><br>D.Identify vascular inflammation PET scan <br/ ><br>E. Describe and quantify degree of pulmonary fibrosis <br/ ><br>F. Describe the change across cases and positive controlsTimepoint: 6 Months <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/01/030605 | 27 January 2021 | Immune profile of PIMS-TS | Role of neutralizing antibodies and inflammatory biomarkers in children with Paediatric Inflammatory Multisystem Syndrome - Temporally Associated with SARS-CoV-2 (PIMS-TS) - PIMS-TS Study | | NIHNIRTICER | 20-01-2021 | 20210120 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49363 | Not Recruiting | No | | | | 25-01-2021 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Aishwarya Venkataraman→ | | Department of HIV/AIDS
National Institute for Research in Tuberculosis,
No 1, Mayor Sathyamoorthy Road, Chetpet,
Chennai → | draishwaryav@gmail.com→ | | National Institute for Research in Tuberculosis→ | Inclusion criteria: Stored serum or plasma samples from a previous approved study at KKCTH→ | Exclusion criteria: Caretakers and children who have not consented <br/ ><br>Children admitted to PICU for conditions other than PIMS-TS <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: nil: nil<br>Intervention2: nil: nil<br>Control Intervention1: analysis of neutralising antibodies, various cytokines, gene polymorphism and complement factor: analysis of neutralising antibodies, various cytokines, gene polymorphism and complement factor<br>Control Intervention2: nil: nil<br>→ | a. To identify the different immune phenotypes of PIMS-TS spectrum <br/ ><br>b. Better understanding of immunology of children with PIMS-TS <br/ ><br>c. One year serological follow up for PIMS-TS children <br/ ><br>Timepoint: 3, 6 and 12 months <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/01/030652 | 27 January 2021 | Influence of COVID-19 on the Occurrence of Cleanliness associated Diseases and Antibiotic Use | Impact of COVID-19 on the Incidence of Hygiene-related Diseases and Associated Antimicrobial Use | | Not Applicable | 21-01-2021 | 20210121 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51761 | Not Recruiting | No | | | | 01-02-2021 | 691 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Nishi Mariam Biju→ | | Room number 2
Department of Pharmacy Practice
Manipal College of Pharmaceutical Sciences
Manipal Academy of Higher Education
Manipal
576104 → | sonal.sekhar@manipal.edu→ | 7411338846→ | Manipal College of Pharmaceutical Sciences→ | Inclusion criteria: Patients who came to IP units, in medicine, pediatrics, and infectious diseases departments with typhoid, cholera, influenza, and diarrhea→ | Exclusion criteria: Patients whose diagnosis is not confirmed. <br/ ><br>Immunocompromised patients <br/ ><br>Pregnant and lactating women <br/ ><br>Patients tested positive for COVID-19→ | Health Condition 1: A009- Cholera, unspecified
Health Condition 2: A09- Infectious gastroenteritis and colitis, unspecified
Health Condition 3: J09X- Influenza due to identified novelinfluenza A virus
Health Condition 4: J108- Influenza due to other identifiedinfluenza virus with other manifestations
Health Condition 5: J101- Influenza due to other identifiedinfluenza virus with other respiratory manifestations
Health Condition 6: J100- Influenza due to other identifiedinfluenza virus with pneumonia
Health Condition 7: J111- Influenza due to unidentified influenza virus with other respiratory manifestations
Health Condition 8: J110- Influenza due to unidentified influenza virus with pneumonia
Health Condition 9: A011- Paratyphoid fever A
Health Condition 10: A014- Paratyphoid fever, unspecified
Health Condition 11: A010- Typhoid fever
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Incidence of hygiene related diseases (cholera, typhoid etc. Except coronavirus disease)Timepoint: Pre COVID time point: March 2019 to February 2020 (1 year). COVID time point : March 2020 to November 2021 (21 months).→ | | | | Yes | False | | |
| → | CTRI/2021/01/030647 | 27 January 2021 | Assesement of the risk perception and readiness of current dental students in treating patients during the COVID-19 pandemic
Aimed at identifying the hesitancies and concerns which can then be addressed by dental colleges throughout the country | Risk perception and readiness of dental students to treat patients in view of COVID-19 pandemic. | | Manipal College of Dental Sciences | 21-01-2021 | 20210121 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51078 | Not Recruiting | No | | | | 01-02-2021 | 384 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Arhana De→ | | Manipal College of Dental Sciences, Manipal, Udupi district and TQ → | arhanade@gmail.com→ | 9167870017→ | Manipal College of Dental Sciences, Manipal→ | Inclusion criteria: Participants involved in clinical work as per the course curriculum (3rd years, 4th years, and interns) and willing to answer the questionnaire with informed consent→ | Exclusion criteria: Candidates whose work is mainly limited to pre-clinical section (i.e., 1st years and 2nd years students), candidates who do not respond to the questionnaire→ | | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Response of candidates to risk perception questionsTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2021/01/030651 | 27 January 2021 | Knowledge, Attitude and Practices regarding COVID care in ICU | Questionnaire of best practices in COVID ICU | | SRM Medical College Hospital | 21-01-2021 | 20210121 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49805 | Not Recruiting | No | | | | 31-01-2021 | 200 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Pushparani→ | | Room no.209, Second Floor, B Block, Department of Anaesthesiology, SRM Medical College and Research Centre → | gayathrii.r@gmail.com→ | 9500092905→ | SRM University→ | Inclusion criteria: Post Graduates working in COVID ICU→ | Exclusion criteria: NIL→ | | Intervention1: Questionnaire: Questionnaire circulated among the pg students to access their knowledge and Attitude towards Covid ICU.<br>→ | To assess the <br/ ><br>Best practices <br/ ><br>Knowledge <br/ ><br>Attitude <br/ ><br>Perception of Post graduates posted in covid icuTimepoint: One week after circulating the questionnaire→ | | | | Yes | False | | |
| → | CTRI/2021/01/030661 | 27 January 2021 | Study to prove the use of Svasth Viral detection scanner using Near Infrared technology for Covid-19 detection and Viral load without taking Nasal or mouth swab or even blood sample.Comparing the results with RT-PCR results which is the current gold standard in Covid-19 detection. | Pilot study of Svasth Viral Detection Device in detecting Covid-19 patients and viral load in patients in comparison with RT-PCR. - SVASTH viral scan | | Miisky Technovation Pvt Ltd | 21-01-2021 | 20210121 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48292 | Not Recruiting | No | | | | 25-01-2021 | 250 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | G Jagannathan→ | | #211 A, Temple Street, 9th Main, BEML 3rd Stage, Rajarajeshwarinagar #211 A, Temple Street, 9th Main, BEML 3rd Stage, Rajarajeshwarinagar→ | drmanju26@gmail.com→ | 9986093019→ | Mandya Institute of Medical Sciences→ | Inclusion criteria: 1 Age 25-80 years (both inclusive) at the time of signing ICF <br/ ><br>2 Patients who have tested positive for RT-PCR testing & are undergoing treatment as inpatients <br/ ><br>3 Voluntarily participating in the clinical study fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures <br/ ><br>4 Patients who have tested negative for RT-PCR testing either for initial detection or post Covi-19 treatment <br/ ><br>→ | Exclusion criteria: 1 Participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely <br/ ><br>2 Cross reactive viral positive for HIV, HbsAg, NL-63, CoV1. <br/ ><br>3 Pregnant & Lactating women. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J988- Other specified respiratory disorders
Health Condition 3: J988- Other specified respiratory disorders
Health Condition 4: B999- Unspecified infectious disease
→ | Intervention1: nil: nil<br>→ | 1 Calibration of Svasth Viral Detection device with RT-PCR-CT values for positive & Negative Covid-19 patients <br/ ><br> <br/ ><br>2 Predict Viral Load based on the MLR algorithm of the Near Infra Red sensors combination <br/ ><br> <br/ ><br>3 Improvise the prediction and algorithm and continue prediction on of Covid-19 positive and negative patients <br/ ><br>Timepoint: Outcome 1 3 WEEKS <br/ ><br>Outcome 2 6 WEEKS <br/ ><br>Outcome 3 12 weeks <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/01/030679 | 27 January 2021 | Infections of lungs in a COVID patients with symptoms and detection of its antibiotic sensitivity . | Lower Respiratory Tract Coinfections in Symptomatic COVID-19 Patients to Determine Etiological Agent and its Antibiotic Sensitivity Pattern: A Cross Sectional Descriptive Pilot Study | | AIIMS Rishikesh | 22-01-2021 | 20210122 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50788 | Not Recruiting | No | | | | 31-03-2021 | 30 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Biswajeet Sahoo→ | | Department of Microbiology, AIIMS Rishikesh All India Institute of Medical Sciences, Vidharbha Road, Uttarkhand- 249203→ | biswajeet.micro@aiimsrishikesh.edu.in→ | 9402733188→ | AIIMS Rishikesh→ | Inclusion criteria: Moderate to severe admitted COVID patients→ | Exclusion criteria: Refusal of consent by the patient→ | Health Condition 1: J22- Unspecified acute lower respiratory infection
Health Condition 2: J22- Unspecified acute lower respiratory infection
Health Condition 3: J22- Unspecified acute lower respiratory infection
Health Condition 4: J22- Unspecified acute lower respiratory infection
→ | | 1. To identify coinfections in COVID symptomatic patients. <br/ ><br>2. To formulate antibiotic stewardship policy of the hospital for moderate and severe COVID patients. <br/ ><br>Timepoint: one year <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/01/030680 | 27 January 2021 | A study to find out the stress among the dental students before and during the Covid-19 situation | A study to assess the stress among dental students before and during the covid -19 pandemic | | Prasanna school of Public Health | 22-01-2021 | 20210122 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51368 | Not Recruiting | No | | | | 27-01-2021 | 77 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Dr Arathi Rao→ | | Room no. 60, First floor, Prasanna School of Public Health, Mahadev Nagar, Manipal, Karantaka, 576104 Udupi
Karnataka
576104
India
→ | arathi.anil@manipal.edu→ | 08202923111→ | Prasanna School Of Public Health→ | Inclusion criteria: Students doing internship (dental) at Kalinga Institute of Dental Sciences, Bhubaneswar→ | Exclusion criteria: → | | | To examine the stress during clinical postings among dental students before and during the ongoing pandemic.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/01/030722 | 27 January 2021 | Study of clinical, radiological presentation and outcomeof Covid 19 positive patients | Study of clinical, radiological presentation and outcomeof Covid 19 positive patients admitted at Tertiary care centre. | | Dr Krutesh Tripathi | 22-01-2021 | 20210122 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51390 | Not Recruiting | No | | | | 25-01-2021 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Krutesh Tripathi→ | | Department of Respiratory Medicine,GCS Medical College and Research Centre,Opp. DRM Office, Near Chamunda Bridge, Naroda Road,Ahmedabad Opp. DRM Office, Near Chamunda Bridge, Naroda Road,Ahmedabad-380025→ | krutesh96@gmail.com→ | 9408500257→ | GCS Medical College and Research Centre→ | Inclusion criteria: RT-PCR /Rapid antigen positive patient (diagnosed as per ICMR guidelines) <br/ ><br>Patient admitted at GCS hospital <br/ ><br>Patient willing to give consent to join study <br/ ><br>→ | Exclusion criteria: RT-PCR /Rapid antigen negative patient <br/ ><br>Patient not willing to get admitted at GCS hospital <br/ ><br>Pregnant woman <br/ ><br>Patient not willing to give consent to join study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To evaluate symptoms, signs , co-morbidities in patients who are COVID 19 positive by Rapid antigen/RT PCR testing. <br/ ><br>To evaluate chest x ray finding/ HRCT thorax findings ( if available) <br/ ><br>To evaluate outcome at the time of discharge (cured, deterioration, persistence or recurrence of clinical /radiological signs and impact of clinical presentation, death), co-morbidities and severities of radiological lesion on outcome <br/ ><br>Timepoint: at the time of Discharge <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/01/030733 | 27 January 2021 | Clinical study on Zandu Chyawanprash, Zandu Pure Honey, Trishun Tablets and Immuzan Tablets as an add to treatment of Covid 19 | A Prospective, Randomized, Open Label, two arm, comparative clinical study to evaluate the efficacy and safety of Fixed Ayurvedic Regimen (Zandu Chyawanprash plus Zandu Pure Honey plus Trishun Tablets plus Immuzan Tablets) as an add on to Conventional treatment in the management of Mild & Moderate COVID 19 patients for period of 8 weeks - NIL | | Emami Ltd | 25-01-2021 | 20210125 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51715 | Not Recruiting | No | | | | 01-02-2021 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Outcome Assessor Blinded | Phase 2/ Phase 3 | India→ | Dr Sanjay Tamoli→ | | Target Institute of Medical Education and Research, Department of Medical Services, 4th Floor,
A 402-A,B,C, Jaswanti Allied center, Ramchandra lane extn, Kachpada, Malad W, Mumbai → | targetinstitute@yahoo.com→ | 9322522252→ | Target Institute of Medical Education and Research→ | Inclusion criteria: 1. Patients with mild to moderate symptoms [as per US-CDC classification of COVID-19 <br/ ><br>2. Clinical presentation with Laboratory (RT-PCR or Rapid antigen or any other test for COVID19 as per current guidelines) confirmed infection of COVID-19 <br/ ><br>3. Subjects having symptoms not more than 3 days <br/ ><br>4. Ready to provide written informed consent for participation in the study <br/ ><br>5. Willing to follow COVID-19 (prevention and containment) related guidelines issued from time to time by Govt/ local health authority throughout the study period. <br/ ><br>→ | Exclusion criteria: 1. Patients with known history of Diabetes Mellitus <br/ ><br>2. Patients having difficulty in swallowing oral medications. <br/ ><br>3. AYUSH system-based contraindications <br/ ><br>4. Patients suffering from severe COVID-19 disease as judged by a physician and fulfilling at least two of the following three criteria <br/ ><br>(i) Respiratory distress at room ambience (Greater than or equal to 30 breaths per min) <br/ ><br> (ii) Oxygen saturation at rest less than or equal to 93 percent (peripheral digital oxymeter) and requiring oxygen support for over one hour to normalize <br/ ><br>(iii) Any of the known COVID-19 complications and emergency procedures which may require shift/admission in intensive care unit such as respiratory failure, adult respiratory distress syndrome, requirement of oxygen support for over 1 hour, requirement of mechanical ventilation, septic shock, or severe non-respiratory organ dysfunction or failure. <br/ ><br>5. Patients who have participated in other clinical trials within last 1 month; <br/ ><br>6. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study <br/ ><br>7. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment. <br/ ><br>8. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>9. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. <br/ ><br>10. Subjects taking steroid treatment and or any kind of immunosuppressive therapy prior to participation in the study <br/ ><br>11. Allergies, known to be allergic to Investigational Products (Ayurvedic Formulations) <br/ ><br>12. Other conditions, which in the opinion of the investigators, makes the patient unsuitable for enrolment or could interfere with his participation in, and completion of the protocol <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Zandu Chyavanprash: Zandu Chyavanprash include Bilva, Agnimantha, Syonaka, Patala, Gambhari, Shalaprani, Prishniparni , Brihati, Kantakari, Gokshura, Bala, Mudgaparni, Mashaparni, Karkatshringi, Tamalaki, Draksha , Jivanti, Pushkara Haritaki ,Guduchi, Vidari, Musta , Rakta Punarnava, Vasa, Kakanasika, Pippali, Sukshmaila, Riddhi &Vriddh, Meda & Mahamedha, Jivaka & Rishabhak, Kakoli & Kshir kakoli. Powder of the Following: Pippali , Vanshalochana, Tvak, Tvakpatra, Sukshmaila, Nagakesara , Amalaki, Til tail, Ghrita, Guda, Honey along with preservatives and excipients<br><br>Dosage and Treatment Duration: Subjects will be given Zandu Chyavanprash in a dose of 10-12 gm twice daily for 8 weeks<br><br>Intervention2: Zandu Immuzan Tablet: Contains extract of Tulasi (Ocimum sanctum Linn.) Wh. Pl., Asvagandha (Withania somnifera Dunal.) Rt., Vasa (Adhatoda vasica Nees) Lf., Sati (Hedychium spicatum Ham. ex Smith) Rz. , Guduci (Tinospora cordifolia (Willd.) Miers.) St., Haridra (Curcuma longa Linn.) Rz. , Kantakari (Solanum surattense Burm. f.) Wh.Pl., Pippali (Piper longum Linn.) Fr., Amalaki (Emblica officinalis Gaertn.) Fr. 6 gm each<br><br><br>Dosage and Treatment Duration: Subjects will be given Zandu Immuzan Tablet in a dose of 2 tablets twice daily for 8 weeks <br><br>Intervention3: Zandu Trishun Tablet: Contains Sudarshan Churna â?? 600mg and Tribhuvankirtirasa â?? 130 mg <br><br>Dosage and Treatment Duration: Subjects will be given Zandu Trishun Tablet in a dose of 1 tablet twice daily for 2 weeks <br><br>Intervention4: Zandu Pure Honey: Contains honey<br><br>Dosage and Treatment Duration: Subjects will be given Zandu Honey in a dose of 1 tsf twice daily for 8 weeks <br><br>Intervention5: Standard care: Conventional Treatment as advised / prescribed by<br>concerned health authorities<br><br>Control Interventio→ | 1. Mean time (days) required for clinical recovery from COVID-19 (Day of randomization to the day of clinical recovery and from the day of first noticed symptoms) <br/ ><br>2. Comparative assessment of post-clinical recovery (signs, symptoms, lab parameters) over a period of 8 weeks between the two groups. <br/ ><br>Timepoint: Screening Visit (Day -3 to day 0) Baseline Visit (Day 0), Evaluation during hospitalization, Day 7, Discharge visit, Day 14, Day 28, Day 42 and Day 56→ | | | | Yes | False | | |
| → | CTRI/2021/01/030743 | 27 January 2021 | The occurence of kidney disease in patients admitted with COVID-19 in a higher treatment centre | Incidence of acute kidney injury in hospitalized patients with Covid-19 from a tertiary care hospital | | Dr Yudhyavir Singh | 25-01-2021 | 20210125 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48798 | Not Recruiting | No | | | | 25-01-2021 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Karthiga R→ | | Dept. of Anaesthesiology, Pain medicine and Critical Care, AIIMS, New Delhi → | yudhyavir@gmail.com→ | 9811140057→ | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: 1. Patients tested COVID-19 positive by RT-PCR or CB-NAAT or Rapid Antigen Test <br/ ><br>2. Age group > 18years <br/ ><br>→ | Exclusion criteria: 1. Patients with Chronic Kidney Disease (CKD) <br/ ><br>2. Patients on Maintenance Hemodialysis <br/ ><br>3. Patients post Kidney transplant <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | Incidence of AKI in patients with Covid-19.Timepoint: 4 months→ | | | | Yes | False | | |
| → | CTRI/2021/01/030729 | 27 January 2021 | Effect of Crocodile breathing versus Prone positioning on heart rate,respiratory rate and oxygen saturation and pulmonary Function test in patients affected by COVID-19: A Pilot Study. | Effect of Crocodile breathing versus Prone positioning on physiological parameters and pulmonary function tests in patients affected by COVID-19: A Pilot Study. | | nil | 25-01-2021 | 20210125 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51654 | Not Recruiting | No | | | | 30-01-2021 | 30 | Interventional | Randomized, Crossover Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Participant Blinded | N/A | India→ | Dr Gayatri Shrinivas Jere→ | | P.T School and Centre,
T.N.M.C and B.Y.L Nair Charitable Hospital,
Mumbai Central, Mumbai. Maharashtra → | drrajvisheth@gmail.com→ | 9821266195→ | P.T School and Centre, Topiwala National Medical College and BYLNCH→ | Inclusion criteria: Patients tested positive on Rt-PCR and are admitted. <br/ ><br>- In the age group of 20-60 years. <br/ ><br>- On Nasal Cannula or room air.→ | Exclusion criteria: Those who are unwilling to participate in the study. <br/ ><br>- Pregnant women. <br/ ><br>- Patients who are intubated, on BiPAP or Bag and Mask as lying face down is not comfortable <br/ ><br>with the tubes attached for oxygenation. <br/ ><br>- Recent Surgical intervention <br/ ><br>-Cognitive impairment or Neurological conditions like Stroke, <br/ ><br>-Haemodynamically unstable. <br/ ><br>- Obese patients (BMI > 30 kg/m2) as lying face down is uncomfortable due to abdominal <br/ ><br>bulk.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Crocodile Breathing: Patient lies comfortably on the abdomen side with head in midline resting on both the arms.<br>Inhalation and exhalation are through the nose.<br>-Nasal inhalation should be slowly and for 3 seconds followed by a brief pause.<br>-Nasal exhalation should be slowly and for 4-6 seconds. This is followed by a longer pause.<br>-Then the next breathing cycle is begun.<br>-The air should expand in 360-degree fashion filling the â??cylinderâ?? of the abdomen.<br>-In this anterior chest wall and abdomen is stabilized, upper limbs are stabilised in abduction,<br>because of this during inspiration more pressure is places on the posterior and lateral chest wall<br>and pelvis reducing accessory muscle use.<br>Control Intervention1: Prone position: Patient lies down on the abdomen side with head on one side. Legs are relaxed and the toes can<br>face outwards.<br>Both the arms are by the side of the waist or one arm can be bend with elbow in flexion.<br>→ | 1. To find the effects of Crocodile breathing on physiological parameters <br/ ><br>(PR, RR, SpO2, RPE) and Pulmonary Function test (Single Breath Count test and Chest <br/ ><br>Expansion) in COVID-19 patients. <br/ ><br>2. To find the effects of prone positioning on physiological parameters and Pulmonary Function tests in COVID-19 <br/ ><br>patients. <br/ ><br>3. To compare the effects of Crocodile breathing and prone positioning on physiological <br/ ><br>parameters and Pulmonary Function test in COVID-19 patients.Timepoint: At baseline and immediately post the maneuver.→ | | | | Yes | False | | |
| → | CTRI/2021/01/030734 | 27 January 2021 | Lung Problems in Covid Recovered Patients | Assessment of Pulmonary Complications in Post Covid Patients - NA | | KIMS HOSPITAL | 25-01-2021 | 20210125 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50936 | Not Recruiting | No | | | | 01-02-2021 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Debasis Behera→ | | Department of Pulmonary Medicine
Kalinga Institute of Medical Science,Bhubaneswar Beleswar
Nayabazar
Cuttack
753004→ | debasis.behera3@kims.ac.in→ | 09971852101→ | Kalinga Institute of Medical Science, Bhubaneswar→ | Inclusion criteria: COVID 19 patients 3 months (10-12 weeks) after their hospital discharge <br/ ><br>Age > 18yrs <br/ ><br>Written informed consent available→ | Exclusion criteria: Patients with previous history of asthma/COPD/ILD <br/ ><br>Patients with features of active respiratory tract infection <br/ ><br>Conditions which are contraindications to spirometry <br/ ><br>Pregnant women <br/ ><br>Musculoskeletal disorders that interfere with walking <br/ ><br>Presence of previous cardiovascular disease→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To assess Residual CT Thorax findings, pulmonary function test and <br/ ><br>exercise capacity of recovered covid 19 patients. <br/ ><br>To find the corelation between residual changes with that of the <br/ ><br>severity of the disease and various laboratory parameters.Timepoint: 3-12 MONTHS→ | | | | Yes | False | | |
| NCT04292730 | 1 February 2021 | Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate Coronavirus Disease (COVID-19) Compared to Standard of Care Treatment | A Phase 3 Randomized Study to Evaluate the Safety and Antiviral Activity of Remdesivir (GS-5734™) in Participants With Moderate COVID-19 Compared to Standard of Care Treatment | | Gilead Sciences | 28/02/2020 | 20200228 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04292730 | Not recruiting | Yes | 12 Years | N/A | All | March 15, 2020 | 1113 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | Spain;Sweden;Switzerland;Taiwan;Singapore;Netherlands;Korea, Republic of;Japan;Italy;Hong Kong;Germany;France;China;United Kingdom;Taiwan;Switzerland;Sweden;Spain;Singapore;Netherlands;Korea, Republic of;Japan;Italy;Hong Kong;Germany;France;China;United States;United Kingdom;United States;Iran, Islamic Republic of | | Gilead Study Director | | | | Gilead Sciences |
<br> Key Inclusion Criteria:
<br>
<br> - Willing and able to provide written informed consent prior to performing study
<br> procedures (participants = 18 years of age) or assent (participants = 12 and < 18
<br> years of age) prior to performing study procedures. For participants = 12 and < 18
<br> years of age, a parent or legal guardian willing and able to provide written informed
<br> consent prior to performing study procedures
<br>
<br> - Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by
<br> polymerase chain reaction (PCR) test = 4 days before randomization
<br>
<br> - Currently hospitalized and requiring medical care for COVID-19
<br>
<br> - Peripheral capillary oxygen saturation (SpO2) > 94% on room air at screening
<br>
<br> - Radiographic evidence of pulmonary infiltrates
<br>
<br> Key Exclusion Criteria:
<br>
<br> - Participation in any other clinical trial of an experimental treatment for COVID-19
<br>
<br> - Concurrent treatment or planned concurrent treatment with other agents with actual or
<br> possible direct acting antiviral activity against SARS-CoV-2
<br>
<br> - Requiring mechanical ventilation at screening
<br>
<br> - Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit
<br> of normal (ULN)
<br>
<br> - Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants =
<br> 18 years of age {Cockcroft 1976} and Schwartz Formula for participants < 18 years of
<br> age
<br>
<br> Note: Other protocol defined Inclusion/Exclusion criteria may apply.
<br> | | COVID-19 | Drug: Remdesivir;Drug: Standard of Care | Part A: Percentage of Participants in Each Clinical Status Category as Assessed by a 7-Point Ordinal Scale on Day 11 | 26/01/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04292730 | Yes | True | parent | Yes |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04391686 | 8 February 2021 | Resting Energy Expenditure of the COronaVirus (COVID19) Patient in Reanimation Context | Resting Energy Expenditure of the COronaVirus (COVID19) Patient in Reanimation Context | RECOVERY | Centre Hospitalier Arras | 15/05/2020 | 20200515 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04391686 | Recruiting | No | 18 Years | N/A | All | July 3, 2020 | 90 | Observational [Patient Registry] | | | France | | Kathleen Jacquez, MSc | | kathleen.jacquez@gh-artoisternois.fr | 03.21.21.13.19 / Poste 41319 | |
<br> Inclusion Criteria:
<br>
<br> For the Ambulatory Obese Control Group, the inclusion criteria are:
<br>
<br> - Age = 18 years;
<br>
<br> - Patient followed in the nutrition service;
<br>
<br> - Patient who benefited from an indirect calorimetry whatever the indication between
<br> 01/01/20 and 31/12/2020;
<br>
<br> - BMI> 30.
<br>
<br> For the COVID Group and the Resuscitation Control Group, the inclusion criteria are:
<br>
<br> - Age = 18 years;
<br>
<br> - Patient having undergone a resuscitation stay
<br>
<br> - Patient on mechanical ventilation (intubated or tracheotomized) during their stay in
<br> intensive care;
<br>
<br> - Patient having benefited from an indirect calorimetry upon arrival in intensive care;
<br>
<br> Only for the COVID Group:
<br>
<br> - Patient hospitalized in intensive care for COVID 19 infection diagnosed by a positive
<br> PCR via nasopharyngeal sampling or endotracheal aspiration.
<br>
<br> - Patient who has not yet carried out his post-resuscitation visit;
<br>
<br> Only for the Resuscitation Control Group:
<br>
<br> - Patient hospitalized in intensive care for an indication other than an infectious cause.
<br>
<br> Exclusion Criteria:
<br>
<br> Non-inclusion criteria for the Ambulatory Obese Control Group:
<br>
<br> - Person deprived of liberty;
<br>
<br> - Person subject to legal protection measures;
<br>
<br> - Patient's opposition to participate in research.
<br>
<br> The non-inclusion criteria for the COVID Group and the Resuscitation Control Group:
<br>
<br> - For patients intubated during the resuscitation stay Fi02> 70% which does not allow a
<br> correct interpretation of the calorimetry;
<br>
<br> - Pregnancy ;
<br>
<br> - Person deprived of liberty;
<br>
<br> - Person subject to legal protection measures;
<br>
<br> - Opposition of the patient or the person of trust to participate in the research.
<br>
<br> Only for the COVID Group:
<br>
<br> - Contraindication to indirect calorimetry (claustrophobia for post-resuscitation
<br> patients where calorimetry is performed with a mask);
<br>
<br> - Contraindication to bioimpedancemetry (electronic implants, limb amputation, weight
<br> <30kg or> 300kg);
<br> | | COVID-19;Obesity | Diagnostic Test: indirect calorimetry | The resting energy expenditure (in Kcal / 24h) measured by indirect calorimetry during the stay in intensive care. | | | | Yes | False | | |
| → | NCT04403100 | 8 February 2021 | Hydroxychloroquine and Lopinavir/ Ritonavir to Improve the Health of People With COVID-19: "The Hope Coalition - 1" | Hydroxychloroquine and Lopinavir/ Ritonavir for Hospitalization and Mortality Reduction in Patients With COVID-19 and Mild Disease Symptoms: "The Hope Coalition" | | Cardresearch | 23/05/2020 | 20200523 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04403100 | Recruiting | No | 18 Years | N/A | All | June 3, 2020 | 1968 | Interventional | Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | Brazil | ; | Gilmar Reis, MD, PhD;Gilmar Reis, MD, PhD | | ;greisbh@uol.com.br | ;+5531332416574 | Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA; |
<br> Inclusion Criteria:
<br>
<br> Patients with RT-PCR diagnosis of COVID-19 or a clinical condition compatible with COVID-19
<br> and respiratory symptoms, presenting:
<br>
<br> A. Persistent dry cough associated with axillary temperature > 37.7 Celsius;
<br>
<br> OR
<br>
<br> B. Recent onset of Flu-like Respiratory Symptoms associated with dry cough
<br>
<br> OR
<br>
<br> C. Tomographic image compatible with COVID 19 infection;
<br>
<br> 2. Men and women aged > 50 years OR: Patients over 18 years of age with at least one of the
<br> following criteria
<br>
<br> - Diabetes requiring oral medication or insulin.
<br>
<br> - Arterial hypertension requiring at least 01 oral medication for treatment
<br>
<br> - Known cardiovascular diseases (CHF of any etiology, documented Coronary Artery
<br> Disease, Clinically overt heart disease)
<br>
<br> - Symptomatic chronic lung disease and/ or medically controlled
<br>
<br> - Patients with a history of transplantation
<br>
<br> - Patient with stage IV chronic kidney disease or on dialysis.
<br>
<br> - Patients on current Immunosuppression and/or using corticosteroid therapy (equivalent
<br> to at least 10 mg of oral prednisone per day)
<br>
<br> - Willingness to comply with study related procedures
<br>
<br> 3. Ability to provide informed consent before any protocol-related procedures.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. RT-PCR exam for COVID-19 negative during the screening visit.
<br>
<br> 2. Patients with an acute respiratory condition compatible with COVID-19 being
<br> hospitalized;
<br>
<br> 3. Patients with an acute respiratory condition and with moderate to high probability of
<br> not being a COVID infection 19;
<br>
<br> 4. Dyspnea secondary to other acute and chronic respiratory causes or infections (eg,
<br> decompensated Chronic Obstructive Pulmonary Disease, acute bronchitis, pneumonia,
<br> primary pulmonary arterial hypertension);
<br>
<br> 5. Severe respiratory clinical condition, presenting at least ONE of the criteria below:
<br>
<br> 1. Respiratory Rate> 28 / min;
<br>
<br> 2. Arterial Oxygen Saturation < 92% with nasal oxygen therapy at 10 l/ min;
<br>
<br> 3. PaO2 / FIO2 <300 mmHg
<br>
<br> 4. History of Cardiac Arrhythmia or Long QT Syndrome; 5. Use of Medications that are known
<br> to prolong QTc: Citalopram, Venlafaxine, Bupropion and with no possibility of suspension
<br> during the period of investigational medical product administration. 6. Inability to take
<br> oral medications; 7. Patients on continuous use of Amiodarone and / or PGE5 Inhibitors (Ex
<br> .: Sildenafil and similar). 8. Use of Digoxin, Cyclosporine, Cimetidine, Tamoxifen. 9. Use
<br> of anticonvulsants, antifungals, immunosuppressants other than corticotherapy. 10. Use of
<br> Hydroxychloroquine for other indications 11. Use of chemoprophylaxis for malaria. 12.
<br> Psoriasis in a form other than cutaneous 13. Porphyria 14. Use of protease inhibitors,
<br> ritonavir or Cobicistat 15. Clinical history of Liver Cirrhosis or Child-Pugh C
<br> classification; 16. Patients with a history of degenerative retinal diseases (patients with
<br> retinal diseases due to diabetes and hypertension can participate in the research); 17.
<br> Patient with a clinically relevant history of hearing loss; 18. Patients with known severe
<br> degenerative neurological diseases and / or severe mental illness; 19. Inability of the
<br> patient or representative to give consent or adhere to the procedures proposed in the
<br> protocol; 20. Known hypersensitivity and / or intolerance to Hydroxychloroquine. 21.
<br> Hypersensitivity and / or intolerance Lopinavir / Ritonavir
<br>
<br> -
<br> | | COVID-19;Coronavirus Infection;Virus Disease;Acute Respiratory Infection;SARS-CoV Infection | Drug: Hydroxychloroquine Sulfate Tablets;Drug: Lopinavir/ Ritonavir Oral Tablet;Drug: Hydroxychloroquine Sulfate Tablets plus Lopinavir/ Ritonavir Oral Tablets;Drug: Placebo | Proportion of participants who were hospitalized for progression of COVID-19 disease;Proportion of participants who died due to COVID-19 progression and/ or complications→Proportion of participants who died due to COVID-19 progression and/ or complications;Proportion of participants who were hospitalized for progression of COVID-19 disease | | | | Yes | False | | |
| NCT04403932 | 8 February 2021 | Increased Risk of Severe Coronavirus Disease 2019 in Patients With Vitamin D Deficiency | Cohort Study to Determine the Association Between Vitamin D Deficiency and Severity of the Disease in Patients With Coronarvirus Disease 2019 (COVID-19) | COVIT-D | Hospital San Carlos, Madrid | 24/05/2020 | 20200524 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04403932 | Not recruiting | No | 18 Years | N/A | All | April 17, 2020 | 300 | Observational | | | Spain | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - >18 years old
<br>
<br> - symptoms suggestive of COVID-19
<br>
<br> - positive reverse-transcriptase polymerase chain reaction or antibodies for SARS-CoV-2
<br>
<br> Exclusion Criteria:
<br>
<br> - Bacterial community acquired pneumonia
<br> | | Coronavirus Disease 2019 (COVID-19) | | severe COVID-19 | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04682912 | 8 February 2021 | Blood Types in Children With COVID-19 | ABO-Rh Blood Types and COVID-19 Infection in Children: Is There a Link? | | Mersin Training and Research Hospital | 22/12/2020 | 20201222 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04682912 | Recruiting | No | 1 Month | 18 Years | All | January 30, 2021 | 2000 | Observational | | | Turkey | ; ; ; | Ali? Özdemi?r, MD;Ali? Özdemi?r;Ali? Özdemi?r, MD;Ali? Özdemi?r, MD | | ;;aliozdemir@hotmail.com;aliozdemir@hotmail.com | ;;03242251000;03242251000 | Mersi?n Sehi?r Egi?ti?m Ve Arasti?rma Hastanesi?;Mersi?n Sehi?r Egi?ti?m Ve Arasti?rma Hastanesi?; |
<br> Inclusion Criteria:
<br>
<br> - The study period consisted between March 2020 and December 2020
<br>
<br> - Children with a documented positive COVID-19 nasal smear real-time
<br> reverse-transcriptase polymerase chain reaction (PCR) assay were included.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who had a past medical history of any chronic illness (related to
<br> respiratory, cardiology, immunology, neurology, metabolic, etc) were excluded.
<br> | | COVID-19 Infection | | Patient medical files | | | | Yes | False | | |
| → | NCT04691180 | 8 February 2021 | A Phase 1 Study of Human Monoclonal Antibodies, BRII-196 and BRII-198 | A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibodies, Brii-196 and BRII-198, Administered Intravenously to Healthy Adult Volunteers | | Brii Biosciences Limited | 17/12/2020 | 20201217 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04691180 | Recruiting | No | 18 Years | 49 Years | All | January 5, 2021 | 24 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). | Phase 1 | China | ; | Yao Zhang;Lili Chen | | ;lili.chen@briibio.com | ;+86 10 6299 8808 | TSB Therapeutics (Beijing) CO.LTD; |
<br> Inclusion Criteria:
<br>
<br> 1. Subject must be 18 to 49 years of age inclusive
<br>
<br> 2. Body weight =100 kg and body mass index (BMI) within the range of 19.0-26.0kg/m2
<br> (inclusive).
<br>
<br> 3. Male or female
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Any clinically significant chronic or acute medical condition that makes the volunteer
<br> unsuitable for participation.
<br>
<br> 2. A history of significant hypersensitivity, intolerance, or allergy to any drug
<br> compound
<br>
<br> 3. History of alcohol or other substance abuse
<br> | | COVID-19 | Drug: BRII-196 and BRII-198;Drug: Placebo | Incidence of adverse events (AEs) by CTCAE v5.0;Proportion of subjects with SAEs→Proportion of subjects with SAEs;Incidence of adverse events (AEs) by CTCAE v5.0 | | | | Yes | False | | |
| NCT04692129 | 8 February 2021 | Prone Positioning Short-term Effects on Tissue Oxygen Saturation in Critical COVID-19 Patients | Short-term Effects of Prone Positioning on Tissue Oxygen Saturation, Measured by Near-infrared Spectroscopy, in COVID-19 Patients With Acute Respiratory Distress Syndrome | PRONECOVID19 | Corporacion Parc Tauli | 30/12/2020 | 20201230 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04692129 | Recruiting | No | 18 Years | N/A | All | May 29, 2020 | 100 | Observational | | | Spain;Mexico;Brazil;Spain;Mexico;Brazil | ; | Jaume Mesquida;Jaume Mesquida, MD, PhD | | ;jmesquida@tauli.cat | ;+34 937231010 | Parc Taulí Hospital Universitari; |
<br> Inclusion Criteria:
<br>
<br> - COVID-19 patients admitted in the ICU receiving invasive mechanical ventilation and
<br> requiring prone positioning for severe hypoxemia management, as decided by the medical
<br> team
<br>
<br> Exclusion Criteria:
<br>
<br> - Severe peripheral vasculopathy
<br>
<br> - Raynaud's syndrome
<br>
<br> - Skin lesions/trauma in upper limbs interfering the placement of the NIRS probe and/or
<br> the occlusion tourniquet
<br>
<br> - Deep venous thrombosis in the upper limbs
<br> | | Covid19;ARDS, Human | | Change in tissue oxygenation (StO2);Change in local hemoglobin content (THC) | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04726865 | 8 February 2021 | COVID-19 Pandemic and Medical Students | Effects of COVID-19 Pandemic on Medical Students in Jordanian Universities: A Multi-center Cross-sectional Study | | University of Jordan | 25/01/2021 | 20210125 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04726865 | Not recruiting | No | 18 Years | 24 Years | All | October 1, 2020 | 415 | Observational | | | Jordan | | Naser U Al-Husban | | | | the University Of Jordan |
<br> Inclusion Criteria:
<br>
<br> - Medical students in the basic and clinical years
<br>
<br> Exclusion Criteria:
<br>
<br> - Inability to complete the questionnaire
<br> | | the Effect of COVID-19 Pandemic | Other: Naser Al-Husban | psychological stress and academic results | | | | No | False | | |
| → | NCT04728880 | 8 February 2021 | Remdesivir in Adults With Covid-19: Mansoura University Hospital Experience | Remdesivir in Adults With Covid-19: Mansoura University Hospital Experience | | Mansoura University | 26/01/2021 | 20210126 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04728880 | Recruiting | No | 18 Years | N/A | All | January 26, 2021 | 300 | Observational | | | Egypt | | El Sharawy Kamal, Professor | | muh@mans.edu.eg | 002 050 2202876 | |
<br> Inclusion Criteria:
<br>
<br> 1. Adult = 18 years old.
<br>
<br> 2. SARS-CoV-2 infection confirmed.
<br>
<br> 3. Patients having classical radiological lesions of COVID-19 on X-ray chest or HRCT
<br> chest.
<br>
<br> 4. Hospitalized patients who received at least one administration of Remdesivir therapy
<br> (Dose: 200mg day one then 100mg daily for up to 10 days).
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Presences of chronic renal failure > 4 stage, GFR < 30ml/min.
<br>
<br> 2. ALT/AST > 5 times than normal values.
<br>
<br> 3. Pregnant women.
<br> | | Pneumonia, Viral | Drug: Remdesivir | Change from baseline in The Sequential Organ Failure Assessment score (SOFA score);Change from baseline in cardiac troponin;Change from baseline in creatinine kinase;Change from baseline in liver enzyme ALT;Change from baseline in serum creatinine;Change from baseline in prothrombin time;Change from baseline in Serum ferretin;Change from baseline in Interleukin-6;Change from baseline in procalcitonin;Change from baseline in D-dimer;Change from baseline in arterial blood gas analyses;Change from baseline in blood pressure;Change from baseline in body core temperature;Change from baseline in respiratory rate;Change from baseline in Pulse rate;Change from baseline in lactate dehydrogenase;Change from baseline in lymphocyte count;Change from baseline in White blood cell count;Change from baseline in Spo2 / FIO2 ratio→Change from baseline in The Sequential Organ Failure Assessment score (SOFA score);Change from baseline in cardiac troponin;Change from baseline in creatinine kinase;Change from baseline in liver enzyme ALT;Change from baseline in serum creatinine;Change from baseline in prothrombin time;Change from baseline in Serum ferretin;Change from baseline in Interleukin-6;Change from baseline in procalcitonin;Change from baseline in D-dimer;Change from baseline in lactate dehydrogenase;Change from baseline in lymphocyte count;Change from baseline in White blood cell count;Change from baseline in Spo2 / FIO2 ratio;Change from baseline in arterial blood gas analyses;Change from baseline in blood pressure;Change from baseline in body core temperature;Change from baseline in respiratory rate;Change from baseline in Pulse rate | | | | Yes | False | | |
| NCT04728906 | 8 February 2021 | Heart Patch for Myocardial Infarction COVID-19 | Targeted-cell Therapy Using Epithelial Stem Cells and Patients' Cardiomyocytes Loaded in Amnion Bilayer to Regenerate Myocardial Infarction Post COVID-19 Complication | | Rumah Sakit Pusat Angkatan Darat Gatot Soebroto | 26/01/2021 | 20210126 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04728906 | Not recruiting | No | 40 Years | 60 Years | All | March 5, 2021 | 10 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | | | Normalina Sandora, MD, PhD | | normalinasandora@gmail.com | +62 812-9896-3425 | |
<br> Inclusion Criteria:
<br>
<br> - Aged 40 - 60 years old
<br>
<br> - Scanning of Technetium-99 shows ischemic burden >10% and ischemic gradients red-violet
<br>
<br> - Ischemic area is not feasible to be grafted (bypass) due to other conditions such as
<br> diffusion and deep intramuscular vascularization
<br>
<br> - Ejection fraction >30-35%
<br>
<br> - Euro score <8
<br>
<br> Exclusion Criteria:
<br>
<br> - Scanning of Technetium-99 showed black colored ischemic area
<br>
<br> - Patients undergoing other procedures other than bypass such as valve repair
<br>
<br> - Chronic kidney failure
<br>
<br> - Patients have went through several bypass surgeries prior
<br>
<br> - Patients are still COVID-19 positive
<br>
<br> - Immunocompromised patients
<br> | | Myocardial Infarction;Heart Diseases | Device: Heart patch seeded with autologous cardiomyocytes and amnion epithelial stem cells | Change of the ischemic burden (%);Change in the regional heart wall motion abnormality | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04374513 | 16 February 2021 | Community Pharmacists Behaviour During Covid-19 | SURVEY of RETAIL PHARMACISTS KNOWLEDGE, ROLE & BEHAVIOR DURING COVID-19 VIRUS OUTBREAK | | Damanhour University | 02/05/2020 | 20200502 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04374513 | Not recruiting | No | N/A | N/A | All | April 2, 2020 | 318 | Observational | | | Egypt | | Asser Ghoneim, phD | | | | Professor in Pharmacology, Faculty of pharmacy, Damanhour University |
<br> Inclusion Criteria:
<br>
<br> - Post graduated pharmacist. Community pharmacists.
<br>
<br> Exclusion Criteria:
<br>
<br> - under graduated students. not pharmacist.
<br> | | Covid19 | | community pharmacists facing covid-19 | | | | Yes | False | | |
| → | NCT04382625 | 16 February 2021 | Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial | Hydroxychloroquine in SARS-CoV-2 (COVID-19) Pneumonia Trial | | Kootenai Health | 14/04/2020 | 20200414 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04382625 | Not recruiting | No | 18 Years | N/A | All | October 2020 | 0 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 4 | United States | ; ; ; | Sean Cook, D.O.;Jeanette Berg, MD, PhD;Sterling McPherson, PhD;John Roll, PhD | | ;;; | ;;; | Kootenai Health;Kootenai Health;Washington State University;Washington State University |
<br> Inclusion Criteria:
<br>
<br> 1. Age > 18 years of age
<br>
<br> 2. SARS-CoV-2 positive per FDA approved RT-PCR (reverse transcription-polymerase chain
<br> reaction)
<br>
<br> 3. Acute hypoxia (O2 sat < 90 % or paO2 < 60 on room air), or above baseline chronic O2
<br> requirement
<br>
<br> 4. Inpatient admission
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Requires supplemental O2 >10 litres per minute or mechanical ventilation on admission
<br>
<br> 2. Pregnancy
<br>
<br> 3. AST/ALT > 5 times the upper limit normal
<br>
<br> 4. Baseline prolonged QT
<br>
<br> 5. Child-Pugh Score B or greater
<br>
<br> 6. ESRD(end-stage renal disease) requiring dialysis
<br>
<br> 7. Known allergy to medication component,
<br>
<br> 8. History of severe G6PD (glucose-6-phosphate dehydrogenase)
<br>
<br> 9. Myasthenia gravis
<br>
<br> 10. Porphyria
<br>
<br> 11. Ongoing treatment for epilepsy
<br>
<br> 12. Life expectancy < 6 months,
<br>
<br> 13. Patient lacks capacity to provide consent and does not have a surrogate decision
<br> maker.
<br>
<br> 14. Retinal Disease
<br> | | SARS-CoV-2 Pneumonia;COVID-19 | Drug: Hydroxychloroquine | Change from Baseline Oxygenation on Day 1 to Day 5;Change from Baseline Oxygenation at Day 5→Change from Baseline Oxygenation at Day 5;Change from Baseline Oxygenation on Day 1 to Day 5 | | | | Yes | False | | |
| NCT04384731 | 16 February 2021 | Curosurf® in Adult Acute Respiratory Distress Syndrome Due to COVID-19 | Randomized Controlled Phase II Trial of Poractant Alfa (Curosurf®) by Fiberoptic Bronchoscopy-directed Endobronchial Administration in Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 Viral Pneumonia | Caards-1 | Dr Christophe LENCLUD | 07/05/2020 | 20200507 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04384731 | Recruiting | No | 18 Years | 100 Years | All | May 29, 2020 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). | Phase 2 | France | ; ; | Christophe LENCLUD, MD;Sandrine ROUX;Christophe LENCLUD, MD | | ;sroux@ch-versailles.fr; | ;+33139239777; | Hospital of Mantes-la-Jolie, France; |
<br> Inclusion Criteria:
<br>
<br> - At least 18 years
<br>
<br> - Intensive care unit admission.
<br>
<br> - Intubation and mechanical ventilation since less than 72h.
<br>
<br> - Positive end-expiratory pressure = 5 cmH2O.
<br>
<br> - Acute respiratory distress syndrome following Berlin definition.
<br>
<br> - COVID-19
<br>
<br> - PaO2/FiO2 ratio < 150 mmHg during at least 3 hours despite PEP trial.
<br>
<br> - Compliance of the respiratory system < 50 mL/cmH2O
<br>
<br> Exclusion Criteria:
<br>
<br> - Contraindication to prone position.
<br>
<br> - Pregnancy.
<br>
<br> - Weight < 40 kg
<br>
<br> - height < 140 cm or height > 190 cm.
<br>
<br> - Profuse bronchorrhea (at least 1 succion per hour during 3 hours).
<br>
<br> - Other significant cause than ARDS to the respiratory failure.
<br>
<br> - Decision to limit active therapies.
<br>
<br> - No arterial line in place.
<br>
<br> - Obesity with weight / height ratio > 1 kg / cm.
<br>
<br> - Impossible to give neuromuscular blockers (e.g. drug unavailable owing to global
<br> pandemia).
<br>
<br> - Severe chronic respiratory failure with oxygen at home.
<br>
<br> - Other severe acute or chronic organ faillure (eg severe liver cirrhosis, severe
<br> chronic cardiac failure).
<br>
<br> - History of pneumonectomy or pulmonary lobectomy.
<br>
<br> - Patient scheduled for extracorporeal membrane oxygenation.
<br>
<br> - Known hypersensibility to Curosurf.
<br>
<br> - Contraindication to bronchial fibroscopy.
<br>
<br> - Person under legal protection.
<br> | | COVID-19;ARDS, Human | Drug: poractant alfa | Evolution of the PaO2 / FiO2 ratio between the measurements taken before (t0) and one hour after the end of the invasive procedure (H1). | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04669912 | 16 February 2021 | COVID-19 Pandemic Lockdown Effect in Adolescents and Young Adults With Type 1 Diabetes: Positive Results of an Unpreceded Challenge for Telemedicine and Patient Self-management | Observational Study of Glycemic Control and Self-management of Young People (Aged 13 to 25 Years ) With Type 1 Diabetes During COVID-19 Lockdown. | COVIDIABADO | Centre Hospitalier Sud Francilien | 07/12/2020 | 20201207 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04669912 | Not recruiting | No | 13 Years | 25 Years | All | January 15, 2021 | 77 | Observational | | | France | | Alfred PENFORNIS, MD PhD | | | | Centre Hospitalier Sud Francilien |
<br> Inclusion Criteria:
<br>
<br> - Type 1 diabetes
<br>
<br> - Age between 13 and 25 years
<br>
<br> - use of a flash glucose monitoring related to the LibreView cloud platform
<br>
<br> - patients follow-up by the diabetes department of Hopital Sud Francilien or the
<br> diabetes department of Hôpital Bicêtre.
<br>
<br> - patient informed of the study and not having objected to it.
<br>
<br> Exclusion Criteria:
<br>
<br> - patients out of France during lockdown
<br>
<br> - other type of diabetes
<br>
<br> - Duration of diabetes of less than one year
<br>
<br> - patient aged under 13 years or above 26 years old
<br> | | Type 1 Diabetes | Other: glucose control and sensor usage | Changes in percentage of time spent in range 70-180 mg/dL after lockdown compared to before lockdown;Changes in percentage of time spent in range 70-180 mg/dL during first month of lockdown compared to before lockdown;Changes in percentage of time spent in range 70-180 mg/dL during second month of lockdown compared to before lockdown | | | | Yes | False | | |
| → | NCT04672395 | 16 February 2021 | A Controlled Phase 2/3 Study of Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Vaccine (SCB-2019) for the Prevention of COVID-19 | A Double-Blind, Randomized, Controlled, Phase 2/3 Study to Evaluate the Efficacy, Immunogenicity, and Safety of SCB 2019, a Recombinant SARS-CoV-2 Trimeric S Protein Subunit Vaccine for the Prevention of COVID-19 in Participants Aged 18 Years and Older | SCB-2019 | Clover Biopharmaceuticals AUS Pty Ltd | 16/12/2020 | 20201216 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04672395 | Not recruiting | No | 18 Years | N/A | All | March 2021 | 22000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | South Africa;Poland;Philippines;South Africa;Poland;Philippines;Panama;Nepal;Germany;Dominican Republic;Colombia;Brazil;Belgium;Panama;Nepal;Germany;Dominican Republic;Colombia;Brazil;Belgium→South Africa;Poland;Philippines;Panama;Nepal;Germany;Dominican Republic;Colombia;Brazil;Belgium;South Africa;Poland;Philippines;Panama;Nepal;Germany;Dominican Republic;Colombia;Brazil;Belgium | ; | Igor Smolenov, MD, PhD;Vincent Mwangi, MD | | ;Vincent.mwangi@cloverbiopharma.com | ;+1 847-691-8580 | Clover Biopharmaceuticals AUS Pty Ltd; |
<br> Inclusion Criteria:
<br>
<br> 1. Male or females =18 years of age, inclusive.
<br>
<br> 2. Participants who are willing and able to comply with study requirements, including all
<br> scheduled visits, vaccinations, laboratory tests, the electronic completion of the
<br> COVID-19 ePRO and other study procedures.
<br>
<br> 3. Healthy adults or adults with pre-existing medical conditions who are in stable
<br> condition.
<br>
<br> A stable medical condition is defined as disease not requiring significant change in
<br> therapy or hospitalization for worsening disease during the 3 months before enrolment
<br>
<br> 4. Female subjects are eligible to participate in the study if not pregnant, not
<br> breastfeeding, and at least 1 of the following criteria apply:
<br>
<br> • Women of childbearing potential (WOCBP) must have a negative urine pregnancy test
<br> prior to each vaccination. A confirmatory serum pregnancy test may be conducted at the
<br> Investigator's discretion. They must be using a highly effective licensed method of
<br> birth control for 30 days prior to the first vaccination and must agree to continue
<br> such precautions during the study until 90 days after the second vaccination.
<br>
<br> 5. Individuals (or their legally acceptable representative based on local regulations)
<br> willing and able to give an informed consent, prior to screening
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Individuals with laboratory-confirmed SARS-CoV-2 infection (e.g., a positive result
<br> for the Rapid COVID-19 antigen test) or a known history of SARS-CoV-2 infection.
<br>
<br> 2. Individuals with behavioral or cognitive impairment (including drug and alcohol abuse)
<br> in the opinion of the Investigator.
<br>
<br> 3. Individuals with any progressive or severe neurologic disorder, seizure disorder, or
<br> history of Guillian-Barré syndrome.
<br>
<br> 4. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic
<br> agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or
<br> planned receipt during the study period.
<br>
<br> 5. Individuals who are pregnant, or breastfeeding, or planning to become pregnant during
<br> the study period.
<br>
<br> 6. Individuals who have a history of severe adverse reaction associated with a vaccine or
<br> severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccine
<br>
<br> 7. Individuals who have a history of malignancy within 1 year before screening
<br>
<br> 8. Individuals who have received any other investigational product within 30 days prior
<br> to Day 1 or intent to participate in another clinical study at any time during the
<br> conduct of this study.
<br>
<br> 9. Individuals who have received previous vaccination with any coronavirus vaccine.
<br>
<br> 10. Individuals who have received any other licensed vaccines within 28 days prior to
<br> enrollment in this study or who are planning to receive any vaccine up to 14 days
<br> after the second vaccination.
<br>
<br> 11. Individuals with known bleeding disorder that would, in the opinion of the
<br> investigator, contraindicate intramuscular injection.
<br>
<br> 12. Individuals who received any blood/plasma products or immunoglobulins within 60 days
<br> prior to Day 1 or plan to receive it during the study period.
<br>
<br> 13. Individuals with any condition that, in the opinion of the Investigator, may increase
<br> the risk of study participation or interfere with the assessment of the primary study
<br> objectives
<br>
<br> 14. Individuals with fever >37.8°C (=100.04°F; irrespective of method), or any acute
<br> illness at baseline (Day 1) or within 3 days of randomization.
<br> | | COVID-19 | Biological: CpG 1018/Alum-adjuvanted SCB-2019 vaccine;Biological: Placebo; 0.9% saline | Number of Participants with Serious Adverse Events (SAEs), or Medically Attended AEs (MAAEs), or AEs Leading to Early Termination, or Adverse Events of Special Interest (AESIs);Number of Participants with Unsolicited AEs;Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs);Number of Participants with a First Occurrence of COVID-19 of Any Severity Starting 14 Days after Second Dose of SCB-2019 | | | | Yes | False | | |
| NCT04678687 | 16 February 2021 | COVID-19 and Tissue Damage in Vital Organs | Evaluation of Postmortem Biopsy Specimens of COVID-19 Cases | | Dokuz Eylul University | 02/12/2020 | 20201202 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04678687 | Not recruiting | No | 18 Years | N/A | All | January 1, 2021 | 10 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | Turkey | ; ; ; ; ; ; ; ; ; | Ali N Gökmen, MD, PhD;Mehmet N Yakar, MD, PhD;Safiye Aktas, MD, PhD;Bilgin Cömert, MD, PhD;Begüm Ergan, MD, PhD;Bisar Ergün, MD, PhD;Firat Bayraktar, MD, PhD;Eyüp S Uçan, MD, PhD;Aylin Erol;Özde E Gökbayrak | | ;;;;;;;;; | ;;;;;;;;; | Dokuz Eylul University, Department of Anaesthesiology and Reanimation, Division of Intensive Care;Dokuz Eylul University, Department of Anaesthesiology and Reanimation, Division of Intensive Care;Dokuz Eylul University, Oncology Institute, Department of Basic Oncology;Dokuz Eylul University, Department of Internal Medicine, Division of Intensive Care;Dokuz Eylul University, Department of Chest Disease, Division of Intensive Care;Dokuz Eylul University, Department of Internal Medicine, Division of Intensive Care;Dokuz Eylul University, Department of Internal Medicine, Division of Endocrinology and Metabolism;Dokuz Eylul University, Department of Chest Disease;Dokuz Eylul University, Oncology Institute;Dokuz Eylul University, Oncology Institute |
<br> Inclusion Criteria:
<br>
<br> - Cases 18 years and older than 18 years.
<br>
<br> - Cases diagnosed with COVID-19 confirmed by PCR test.
<br>
<br> - Cases whose treatment resulted in death.
<br>
<br> - Cases that was allowed the participation in the study by signing the informed consent
<br> form by their first degree relatives.
<br>
<br> Exclusion Criteria:
<br>
<br> - Cases less than 18 years old.
<br>
<br> - Cases for which the diagnosis of COVID-19 could not be confirmed.
<br>
<br> - Cases for which informed consent could not be obtained.
<br>
<br> - Cases whose treatment continues or results in healing.
<br> | | Covid19;Postmortem Changes | Procedure: Liver, lung, heart and kidney biopsy | The level of histopathological changes | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04581863 | 22 February 2021 | COVID-19 Watch + COVID-19 Pulse | Randomized Trial of Adding Pulse Oximetry to an Automated Text-messaging Program for Remotely Monitoring Patients at Home With COVID-19 | | University of Pennsylvania | 07/10/2020 | 20201007 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04581863 | Not recruiting | No | 18 Years | N/A | All | November 30, 2020 | 850 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - patients with suspected or confirmed COVID-19 started on COVID Watch as routine care
<br> via (1) outpatient COVID-19 testing or (2) who were tested for COVID-19 and discharged
<br> from the ED.
<br>
<br> Exclusion Criteria:
<br>
<br> - less than 18 years of age
<br>
<br> - were provided a pulse oximeter upon discharge from the ED (available for distribution
<br> as usual care for patients with suspected COVID-19 being discharged from the ED with
<br> an ED pulse ox less than 95%, who have an infiltrate on chest x-ray, are greater than
<br> 60 years of age, or who are deemed by the ED clinician to have significant comorbid
<br> conditions).
<br> | | Covid19 | Device: pulse oximeter;Other: COVID Watch | Difference in Days Alive and Out of Hospital | | | | Yes | False | | |
| → | NCT04584697 | 22 February 2021 | Study to Evaluate the Safety, Pharmacokinetics and Efficacy of STI-2020 (COVI-AMG™) in Outpatients With COVID-19 | A Randomized, Placebo-controlled Study to Evaluate the Safety, Pharmacokinetics and Efficacy of a Single Dose of STI-2020 (COVI-AMG™) in Outpatients With COVID-19 Who Are Asymptomatic or Have Mild Symptoms | | Sorrento Therapeutics, Inc. | 07/10/2020 | 20201007 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04584697 | Not recruiting | No | 18 Years | N/A | All | December 2020 | 0 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | | | Mike Royal, MD | | | | Sorrento Therapeutics |
<br> Inclusion Criteria:
<br>
<br> - Must be COVID-19 positive by RT-PCR or an equivalent test, using an appropriate sample
<br> such as nasopharyngeal [NP], nasal, oropharyngeal [OP], or salivary) = 72 hours prior
<br> to randomization. A historical record of positive result from test conducted = 72
<br> hours prior to randomization is acceptable if it can be documented.
<br>
<br> - Must be asymptomatic OR have mild symptoms but not requiring imminent (within 24h)
<br> hospitalization.
<br>
<br> - Must be willing and able to comply with all planned study procedures and be available
<br> for all study visits and follow-up as required by this protocol.
<br>
<br> - Subject or family member/caregiver must have provided written informed consent which
<br> includes signing the institutional review board approved consent form prior to
<br> participating in any study related activity.
<br>
<br> Exclusion Criteria:
<br>
<br> - Have a documented infection other than COVID-19 that requires systemic treatment or in
<br> the investigator's opinion could interfere with the participant's safety or interfere
<br> with the assessments if enrolled in the study.
<br>
<br> - Have any medical condition that, in the Investigator's opinion, could adversely impact
<br> safety.
<br>
<br> - Be pregnant or lactating and breast feeding
<br>
<br> - Has participated, or is participating, in a clinical research study evaluating
<br> COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or
<br> intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the
<br> investigational product (whichever is longer) prior to the screening visit. Note:
<br> subjects who have been prescribed hydroxychloroquine or chloroquine with or without
<br> azithromycin or other approved products for the off-label treatment of COVID-19 prior
<br> to study enrollment may be included and may continue to receive these agents so long
<br> as the dose remains stable. Additionally, any approved or authorized treatment (e.g.,
<br> remdesivir, dexamethasone or treatments approved under an Emergency Use Authorization)
<br> is allowed.
<br> | | Covid19 | Biological: COVI-AMG;Drug: Placebo | Cytokine levels post-treatment;Presence and levels of anti-drug antibodies directed to COVI-AMG;Time from onset of COVID-19 symptoms to treatment (Day 1);Viral load as assessed using plasma and salivary samples at various timepoints;Incidence of clinically meaningful laboratory abnormalities (safety);Incidence of dose-limiting toxicities (safety);Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety);Incidence of adverse events by type, frequency, severity, and causality (safety);Incidence of serious adverse events by type, frequency, severity, and causality (safety)→Cytokine levels post-treatment;Presence and levels of anti-drug antibodies directed to COVI-AMG;Time from onset of COVID-19 symptoms to treatment (Day 1);Viral load as assessed using plasma and salivary samples at various timepoints;Incidence of clinically meaningful laboratory abnormalities (safety);Incidence of dose-limiting toxicities (safety);Incidence of serious adverse events by type, frequency, severity, and causality (safety);Incidence of treatment-emergent adverse events by type, frequency, severity, and causality (safety);Incidence of adverse events by type, frequency, severity, and causality (safety) | | | | Yes | False | | |
| NCT04621461 | 22 February 2021 | Placebo Controlled Trial to Evaluate Zinc for the Treatment of COVID-19 in the Outpatient Setting | A Randomized, Placebo-Controlled Study Evaluating the Efficacy of Zinc for the Treatment of COVID-19 in the Outpatient Setting | | St. Francis Hospital, New York | 06/11/2020 | 20201106 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04621461 | Not recruiting | No | 30 Years | N/A | All | December 20, 2020 | 3 | Interventional | Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 4 | United States | | Avni Thakore, MD | | | | St. Francis Hospital - The Heart Center |
<br> Inclusion Criteria:
<br>
<br> - Able to read and understand informed consent.
<br>
<br> - High initial clinical suspicion by physician based on signs and symptoms (fever,
<br> cough, myalgias, fatigue, shortness of breath) followed by confirmation of COVID-19
<br> diagnosis
<br>
<br> - Any gender
<br>
<br> - Age 60 years and older
<br>
<br> - Age 30-59 years with one or more of the following:
<br>
<br> - abnormal lung exam
<br>
<br> - abnormal oxygen saturation <95%
<br>
<br> - abnormal Chest X-ray or chest CT
<br>
<br> - persistent fever >100.4 degrees Fahrenheit
<br>
<br> - one of the following co-morbidities: hypertension, diabetes mellitus, history of
<br> coronary artery disease, chronic kidney disease (CKD), asthma, COPD, current or
<br> former smoker, or morbid obesity (Body Mass Index =35)
<br>
<br> Exclusion Criteria:
<br>
<br> - Severe COVID-19 requiring admission for inpatient treatment
<br>
<br> - Need for any oxygen supplementation
<br>
<br> - Need for mechanical ventilatory support
<br>
<br> - History of oxygen supplementation dependency
<br>
<br> - History of cancer with ongoing chemotherapy or radiation therapy
<br>
<br> - Known hypersensitivity to zinc
<br>
<br> - Severe renal disease: Glomerular Filtration Rate <30ml/min
<br> | | Corona Virus Infection | Dietary Supplement: Zinc Sulfate 220 MG;Drug: Placebo | Number of participants on a ventilator;Number of participants admitted to the Intensive care unit (ICU);Number of participants hospitalized and/or requiring repeat emergency room visits | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04652596 | 22 February 2021 | Reducing Food Insecurity During COVID-19 | Comparative Effectiveness of Two Interventions to Reduce Food Insecurity During the COVID-19 Pandemic | | Boston Medical Center | 30/11/2020 | 20201130 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04652596 | Recruiting | No | 18 Years | N/A | All | February 8, 2021 | 250 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). | N/A | United States | | Michael Silverstein, MD MPH | | | | Boston Medical Center Department of Pediatrics |
<br> Inclusion Criteria:
<br>
<br> - Parent of a child 0-18 months of age
<br>
<br> - Child receives care at Boston Medical Center
<br>
<br> Exclusion Criteria:
<br>
<br> - Planning to move residence outside of Boston within 12 months
<br> | | Food Insecurity | Other: Produce prescription program;Other: Grocery store gift cards | Change in Food Security | | | | Yes | False | | |
| → | NCT04659239 | 22 February 2021 | The Efficacy, Safety and Immunogenicity Study of Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19 | A Randomized, Double-Blinded, Placebo Controlled Phase III Clinical Trial of SARS-CoV-2 Vaccine, Inactivated (Vero Cell) in Adults Aged 18 Years and Above | | Chinese Academy of Medical Sciences | 05/12/2020 | 20201205 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04659239 | Recruiting | No | 18 Years | N/A | All | January 28, 2021 | 34020 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | Malaysia;Brazil;Malaysia;Brazil | ; | Yasmin binti Mohamed Gani, PhD;Adilson JW Cavalcante, PhD | | ; | ; | Hospital Sungai Buloh;CEMEC Pesquisa Clinica |
<br> Inclusion Criteria:
<br>
<br> 1. Adults aged 18 years and above (including boundary values), both female and male.
<br>
<br> 2. Legal identification of the participants shall be provided.
<br>
<br> 3. Participants shall understand the content in the Informed Consent Form (ICF) and the
<br> vaccine for administration, sign the ICF voluntarily and are capable of using
<br> thermometers and rulers, and filling in diary cards and contact cards as per the
<br> requirements.
<br>
<br> 4. Subject shall be able to communicate well with investigators, understand and comply
<br> with the requirements of this study.
<br>
<br> 5. Participants with oral temperature = 37.9 ?.
<br>
<br> 6. Female participants of childbearing potential (defined as any female who has
<br> experienced menarche and who is NOT surgically sterile [i.e., hysterectomy, bilateral
<br> tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at
<br> least 12 consecutive months]) must agree to be heterosexually inactive OR consistently
<br> use any of the following methods of contraception:
<br>
<br> 1. Condoms (male or female)
<br>
<br> 2. Diaphragm with spermicide
<br>
<br> 3. Cervical cap with spermicide
<br>
<br> 4. Intrauterine device
<br>
<br> 5. Oral or patch contraceptives
<br>
<br> 6. Any country regulatory-approved contraceptive method that is designed to protect
<br> against pregnancy
<br>
<br> 7. Abstinence, as a form of contraception, is acceptable if in line with the
<br> participant's lifestyle (other approaches to abstinence are not acceptable).
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Contraindications to commonly used vaccines;
<br>
<br> 2. History of allergy to any vaccines or drug;
<br>
<br> 3. Received any vaccine within 1 month before the first dose of vaccination;
<br>
<br> 4. Serious diseases required to be excluded, including but not limited to history of
<br> diseases in nervous system, cardiovascular system, blood and lymphatic system, immune
<br> system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones
<br> and other systems, and a history of malignant tumors;
<br>
<br> 5. Before immunizing the first dose of investigational vaccine, those who developed acute
<br> disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection
<br> within 7 days;
<br>
<br> 6. Those who have a hereditary bleeding tendency or blood coagulation dysfunction, or a
<br> history of thrombosis or hemorrhagic disease;
<br>
<br> 7. Surgical removal of whole or part of spleen for any reason;
<br>
<br> 8. Those who have undergone surgery within 3 months before signing the ICF or those who
<br> plan to undergo surgery during or within 3 months after completion of the trial
<br> (including plastic surgery, dental and oral surgery);
<br>
<br> 9. Those who donated or lost blood (=400 mL) in the past 3 months, who received blood
<br> transfusion or use of blood products, or who plan blood donation during the trial;
<br>
<br> 10. Those who received other investigational or unregistered products (drugs, vaccines,
<br> biological product or devices) in the past 3 months before signing the ICF, or plan to
<br> use them during the study.
<br>
<br> 11. Those who received immunosuppressant therapy within 6 months before signing the ICF,
<br> such as long-term systemic glucocorticoid treatment (with systemic glucocorticoid
<br> therapy for more than 2 consecutive weeks within 6 months, such as prednisone or
<br> similar drugs), but local administration is permitted (such as ointment, eye drops,
<br> inhalants, or nasal spray). The local administration should not exceed the recommended
<br> dose in the package insert or have any signs of systemic exposure;
<br>
<br> 12. Participants cannot meet the criteria through the comprehensive physical examination,
<br> mainly including:
<br>
<br> - Abnormal vital signs with clinical significance (awakening heart rate <55
<br> beats/min or >100 beats/min, systolic blood pressure =140mmHg or diastolic blood
<br> pressure =90mmHg);
<br>
<br> - Those who tested positive for type 1 or type 2 human immunodeficiency virus
<br> (HIV-1/2) antibody, or SARS-CoV-2 nucleic acid;
<br>
<br> 13. History of COVID-19;
<br>
<br> 14. Participants who have a positive pregnancy test, or are breastfeeding, or planning
<br> pregnancy, or plan to donate sperm or eggs within 12 months from the screening period
<br> to the whole-course immunization;
<br>
<br> 15. Participants who are considered as inappropriate for the trial by investigators.
<br>
<br> 16. Suspected or known current alcohol or drug dependency.
<br>
<br> 17. Investigator site personnel directly related to this study and/or their immediate
<br> families; immediate family is defined as a spouse, parent, child, or sibling, whether
<br> biological or legally adopted.
<br> | | COVID-19 | Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell);Biological: Placebo | The incidence of COVID-19 cases after two-doses of vaccination;The incidence of solicited AEs.→The incidence of solicited AEs.;The incidence of COVID-19 cases after two-doses of vaccination | | | | Yes | False | | |
| NCT04662671 | 22 February 2021 | Phase I/II Randomized, Dose Escalation Study to Evaluate the Safety and Antiviral Activity of the RD-X19 Device in SARS-CoV-2 Infected Individuals With Uncomplicated COVID-19 | Phase I/II Randomized, Dose Escalation Study to Evaluate the Safety and Antiviral Activity of the RD-X19 Device in SARS-CoV-2 Infected Individuals With Uncomplicated COVID-19 | | EmitBio Inc. | 09/12/2020 | 20201209 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04662671 | Not recruiting | No | 18 Years | 65 Years | All | November 18, 2020 | 31 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Positive for SARS-CoV-2 antigen via nasal swab at or within the past 24 hours of the
<br> screening visit detected using an FDA authorized SARS-CoV-2 antigen test.
<br>
<br> 2. Onset of signs and symptoms consistent with COVID-19* no longer than within the past 3
<br> days* and have either a) a fever of at least 100 °F or b) at least two moderate or
<br> severe symptoms (cough, sore throat, nasal congestion, headache, chills/sweats, muscle
<br> or joint pain, fatigue, and nausea) at the time of screening.
<br>
<br> 3. Provides written informed consent prior to initiation of any study procedures.
<br>
<br> 4. Be able to understand and agrees to comply with planned study procedures and be
<br> available for all study visits.
<br>
<br> 5. Agrees to the collection of nasopharyngeal swabs, oropharyngeal swabs, oral saliva
<br> specimen collection and venous blood specimens per protocol.
<br>
<br> 6. Agrees to refrain from using oral antiseptics (e.g. hydrogen peroxide rinse,
<br> Listerine) or mouthwashes of any kind during the study.
<br>
<br> 7. Male or non-pregnant female, 18 to 65 years of age, inclusive, at time of enrollment.
<br>
<br> 8. No uncontrolled disease process (chronic or acute), other than COVID-19 signs and
<br> symptoms*.
<br>
<br> 9. No physical or mental conditions or attributes at the time of screening, which in the
<br> opinion of the PI, will prevent full adherence to, and completion of, the protocol.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Positive urine pregnancy test at screening.
<br>
<br> 2. Any medical disease or condition that, in the opinion of the site Principal
<br> Investigator (PI) or appropriate sub-investigator, precludes study participation.
<br>
<br> 3. Presence of self-reported or medically documented uncontrolled significant medical or
<br> psychiatric condition(s) other than COVID-19.
<br>
<br> 4. Reports a recent positive test result (within the past 6 months) for hepatitis B
<br> surface antigen, hepatitis C virus antibody, or HIV-1 antibodies at screening.
<br>
<br> 5. Has a history of alcohol abuse or other recreational drug (excluding cannabis) use
<br> within 1 month of Study Day 1.
<br>
<br> 6. COVID-19 signs associated with acute respiratory distress or imminent serious medical
<br> outcomes. ^^
<br>
<br> 7. BMI =36
<br>
<br> 8. Subjects living (e.g., siblings, spouses, relatives, roommates) in the same household
<br> cannot be enrolled.
<br>
<br> 9. Has participated in another investigational study involving any intervention for
<br> SARS-CoV-2/COVID- 19 within the past 6 months or any clinical trial with
<br> interventional investigational product within 30 days of screening.
<br>
<br> 10. Currently enrolled in or plans to participate in another clinical trial with an
<br> interventional investigational agent that will be received during the studyperiod.
<br>
<br> 11. History of hospitalization within the past 60 days.
<br>
<br> 12. History of systemic antiviral therapies within the past 30 days.
<br>
<br> 13. History of oral corticoid steroid use within the past 14 days or steroid injection
<br> within the past 6 months. Active use of nasal or inhalable steroids is also
<br> exclusionary. Topical steroids are not exclusionary.
<br>
<br> 14. Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis,
<br> generalized urticaria, angioedema, other significant reaction) to nitrites, nitrates,
<br> or sun exposure.
<br>
<br> 15. Has any oral abnormality (e.g. ulcer, oral mucositis, gingivitis) that in the opinion
<br> of the investigator would interfere with device use, or intra-oral metal body
<br> piercings that cannot be removed for the duration of the study. Metal orthodontia is
<br> permitted as braces will be covered by the device mouthpiece.
<br> | | COVID19 | Device: RD-X19 | Primary Safety Measure;Primary Efficacy Measure | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04743388 | 22 February 2021 | Study of the Kinetics of Antibodies Against COVID-19 (SARS-CoV-2) and of Cellular Subpopulations of the Immune System | Study of the Kinetics of Antibodies Against SARS-CoV-2 and of Cellular Subpopulations of the Immune System in Volunteers Receiving the BNT162b2 Vaccine or Other Approved Vaccine Against SARS-CoV-2 | | National and Kapodistrian University of Athens | 03/02/2021 | 20210203 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04743388 | Recruiting | No | 18 Years | N/A | All | January 4, 2021 | 600 | Observational [Patient Registry] | | | Greece | ; ; | Evangelos Terpos;Ioanna Charitaki;Evangelos Terpos, MD | | ;j.charitaki@gmail.com; | ;+30 6976156403; | National and Kapodistrian University of Athens; |
<br> Inclusion Criteria:
<br>
<br> - Healthy volunteers and all individuals who, according to the instructions of the Greek
<br> State are considered eligible to receive the BNT162b2 vaccine
<br>
<br> - Age = 18 years old
<br>
<br> Exclusion Criteria:
<br>
<br> - Serious allergy problems i.e. hospitalization due to a serious allergic reaction
<br> (anaphylaxis)
<br> | | COVID-19;Healthy Volunteers;Chronic Disease;Hematological Malignancies;Solid Tumor | Biological: BNT162b2;Biological: Other vaccine against SARS-Cov-2 | Neutralizing antibodies against SARS-CoV-2 | | | | Yes | False | | |
| → | NCT04745377 | 22 February 2021 | Responses to COVID-19 Vaccination in Patients With Cancer | Mapping the Responses to COVID-19 Vaccination in Patients With Cancer - the ReCOVer Study | ReCOVer | Hellenic Cooperative Oncology Group | 15/01/2021 | 20210115 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04745377 | Recruiting | No | 18 Years | N/A | All | January 12, 2021 | 300 | Observational | | | Greece | ; | Helena Linardou, MD PhD;Helena Linardou, MD PhD | | elinardou@otenet.gr;elinardou@metropolitan-hospital.gr | +302104809339;+302104809339 | |
<br> Inclusion Criteria:
<br>
<br> - Patients with solid tumours and potentially immunocompromised, ie. currently with
<br> active disease and/or undergoing active antineoplastic therapy of any type
<br> (chemotherapy, immunotherapy, biologic therapy, targeted therapy) that will be
<br> vaccinated for covid-19 within the National Program of Vaccination
<br>
<br> - patients must sign informed consent for their data monitoring and also for serum
<br> antibody titers to covid-19 vaccination measured in three timepoints, prior to 1st
<br> dose and 1 and 3 months post completion of two doses
<br>
<br> Exclusion Criteria:
<br>
<br> - patients with haematological malignancies are excluded
<br>
<br> - patients with prior diagnosis of cancer and now on follow-up without active disease
<br> are excluded
<br>
<br> - patients on adjuvant hormonal therapy are excluded
<br> | | Cancer | Diagnostic Test: IgG neutralising antibody titers to S1 and S2 proteins of SARS-COV-2 virus | Serological outcome post vaccination, immune response to vaccination against COVID-19 (measured as antibody titre 3 months after completion of vaccination;Serological outcome post vaccination, immune response to vaccination against COVID-19 (measured as antibody titre 1 month after completion of vaccination;Clinical outcome post vaccination→Clinical outcome post vaccination;Serological outcome post vaccination, immune response to vaccination against COVID-19 (measured as antibody titre 1 month after completion of vaccination;Serological outcome post vaccination, immune response to vaccination against COVID-19 (measured as antibody titre 3 months after completion of vaccination | | | | Yes | False | | |
| NCT04745416 | 22 February 2021 | Clinical Characteristics of Patients With Leukemia and COVID-19 | Clinical Characteristics of Patients With Hematological Cancer Diagnosed and Severe Acute Respiratory Syndrome Coronavirus 2 Infection at the Hospital de Alta Especialidad de Ixtapaluca and the Hospital General de México "Dr. Eduardo Liceaga" | | Hospital General de Mexico | 29/01/2021 | 20210129 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04745416 | Not recruiting | No | 18 Years | N/A | All | January 1, 2020 | 30 | Observational | | | Mexico | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Patients with diagnosis of acute lymphoblastic leukemia according to the criteria of
<br> the World Health Organization.
<br>
<br> Exclusion Criteria:
<br>
<br> - Age less than 18 years
<br>
<br> - Incomplete medical records
<br> | | Leukemia, Acute;Covid19;Leukemia, Lymphoblastic | | Overall survival;Number of relapses;Complete Remission;COVID-19 confirmed;Progression free survival | | | | No | False | | |
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| IRCT20191125045496N3 | 22 February 2021 | Evaluation of the Effect of Pulmonary Rehabilitation in COVID-19 Patients | The Effect of Pulmonary Rehabilitation on Depression, Anxiety, Fatigue and Quality of Life in COVID-19 Patients with one-month Follow-up | | Mazandaran University of Medical Sciences | 2021-01-25 | 20210125 | IRCT | http://en.irct.ir/trial/51644 | Not Recruiting | No | 35 years | 75 years | Both | 2020-04-20 | 40 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Health service research, Randomization description: Randomization method was performed based on random permutation blocks with 4 samples in each block and a random list of data was obtained using Random Allocation software. | N/A | Iran (Islamic Republic of) | Seyed Hamzeh Hosseini | | Imam Khomeini Hospital., Amir Mazandaran St., Sari Town | hosseinish20@gmail.com | +98 11 3310 9231 | Mazandaran University of Medical Sciences | Inclusion criteria: COVID-19 Patients aged 35 to 75 years old<br>No history of chronic diseases such as heart, orthopedic and motor disorders, diabetes, multiple sclerosis and cancer that interfere with the rehabilitation program <br>The ability to use the technology or caregiver that made it possible for him to be quarantined | Exclusion criteria: Asthma and any underlying lung disease are neuromuscular diseases that affect lung function.<br>Lack of patient cooperation and lack of motivation<br>Taking antidepressants and anti-anxiety drugs two months before the intervention | COVID-19. <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: Pulmonary Rehabilitation Group:For this group, 3 training sessions and each session for 60 minutes of pulmonary rehabilitation program will be given face to face and individually. At the end of the third session, an educational illustrated booklet containing the educational content will be provided to patients and the patient After discharge from the hospital, they will be required to perform 3 sessions per week, each session lasting 60 minutes (warm-up, aerobic exercise, strength training, balance training, and cooling) for 6 weeks. Intervention 2: Control group: This group will perform their usual treatments according to the doctor's instructions. Pulmonary rehabilitation will not be performed in these people for 6 weeks. | Fatigue scale. Timepoint: At baseline (before intervention) and 6 weeks after intervention. Method of measurement: Osmens Multidimensional Fatigue Inventory Questionnaire.;Anxiety and Depression scale. Timepoint: At baseline (before intervention) and 6 weeks after intervention. Method of measurement: Hospital Anxiety Depression scale (HADS).;Quality of Life. Timepoint: At baseline (before intervention) and 6 weeks after intervention. Method of measurement: Short Form Quality of Life Questionnaire (SF-36). | | | | No | False | | |
| → | IRCT20201024049134N1 | 22 February 2021 | Efficacy of Arbidol in treatment of COVID-19 | Efficacy of standard and Arbidol treatments in COVID-19 outpatients | | Babol University of Medical Sciences | 2020-11-02 | 20201102 | IRCT | http://en.irct.ir/trial/51847 | Recruiting | No | 65 years | no limit | Both | 2021-01-20 | 80 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Unit randomization is done by block method with a block size of 4. For each of the 6 possible cases for the quadruple block, the numbers are assigned as follows
AABB (1), ABAB (2), ABBA (3), BBAA (4), BABA (5), BAAB (6)
With the help of a table of random numbers, the numbers between 1 and 6 are selected and the treatment allocation list is determined according to each number.
To execute the generated random sequence, the method of hiding coded boxes or cans is used. In this method, the cans are numbered in a random sequence and inside the boxes, the desired intervention (drug) or a sheet on which the random allocation is written, is provided to the executor with the condition that the boxes are completely sealed and The researcher assigns patients to the standard intervention and treatment group based on the order of patients' admission.
Too | 2-3 | Iran (Islamic Republic of) | Mohammad Barary | | No.88, Khosravan 10 ave., Moallem 12 st., Shariaty blvd. | m1377b@gmail.com | +98 11 3236 0124 | Babol University of Medical Sciences | Inclusion criteria: People over the age of 65 who are in high-risk groups (with a history of high blood pressure, diabetes, BMI> 30, COPD, cancer, and etc.)<br>Confirmation of the diagnosis of COVID-19 by chest CT scan and/or rt-PCR<br>Signing an informed consent form | Exclusion criteria: History of allergies to these drugs<br>Use arbidol before hospitalization<br>Pregnant women<br>Respiratory failure and need for mechanical ventilation<br>Renal and/or hepatic failure<br>Anemia and thrombocytopenia<br>Coagulopathy<br>Autoimmune or immune deficiency disorders | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). <br>COVID-19, virus identified;U07.1 | Intervention 1: Control group: standard approved treatment regimen for COVID-19, including famotidine, cetirizine, N-acetylcysteine, bromhexine, naproxen, and fluticasone inhaler for 7 days. Intervention 2: Intervention group: standard approved treatment regimen for COVID-19, including famotidine, cetirizine, N-acetylcysteine, bromhexine, naproxen, and fluticasone inhaler plus arbidol (manufactured by Pharmstandard, Russia) at the dose of two 40 mg capsules every 8 hours for 7 days. | Death. Timepoint: Up to 1 month after the end of the study. Method of measurement: Examination of the patients by infectious disease specialists in an outpatient clinic.;Life-threatening conditions. Timepoint: Up to 1 month after the end of the study. Method of measurement: Examination of the patients by infectious disease specialists in an outpatient clinic.;Hospitalization required. Timepoint: Up to 1 month after the end of the study. Method of measurement: Examination of the patients by infectious disease specialists in an outpatient clinic.;Time of the removal of the symptoms. Timepoint: Up to 1 month after the end of the study. Method of measurement: Examination of the patients by infectious disease specialists in an outpatient clinic.→Time of the removal of the symptoms. Timepoint: Up to 1 month after the end of the study. Method of measurement: Examination of the patients by infectious disease specialists in an outpatient clinic.;Hospitalization required. Timepoint: Up to 1 month after the end of the study. Method of measurement: Examination of the patients by infectious disease specialists in an outpatient clinic.;Life-threatening conditions. Timepoint: Up to 1 month after the end of the study. Method of measurement: Examination of the patients by infectious disease specialists in an outpatient clinic.;Death. Timepoint: Up to 1 month after the end of the study. Method of measurement: Examination of the patients by infectious disease specialists in an outpatient clinic. | | | | Yes | False | | |
| → | IRCT20111121008146N34 | 22 February 2021 | Investigating the effectiveness of laser acupuncture in controlling COVID-19 compared to common medical treatments | Investigating the effectiveness of laser acupuncture in controlling Coronavirus disease 2019 (COVID-19) compared to common medical treatments | | Shahid Beheshti University of Medical Sciences | 2021-01-24 | 20210124 | IRCT | http://en.irct.ir/trial/51948 | Recruiting | No | 30 years | 70 years | Both | 2020-09-22 | 60 | interventional | Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be assigned to treatment groups using random numbers generated by excel software, Blinding description: The data collector and the data analyst are unaware of the group allocations and the treatments. | N/A | Iran (Islamic Republic of) | Arista shojaeddin | | Shohadaye Tajrish Hospital, Tajrish, Tehran | laser.cntr@yahoo.com | +98 21 2274 9221 | Shahid Beheshti University of Medical Sciences | Inclusion criteria: COVID-19 patients with severe acute pneumonia hospitalized in the ward before requiring ICU admission<br>Positive PCR test result<br>Respiratory rate =30 per minute<br>Oxygen saturation = 93%<br>Fraction of inspired oxygen (FIO2) = 300 mmHg<br>Progression of lung lesions by more than 50% within 24-48 hours in the chest CT-scans<br>30 to 70-year-old men and women | Exclusion criteria: A history of cancer<br>A history of benign tumors<br>Pregnancy<br>A history of photosensitivity | COVID-19 (Coronavirus Disease 2019). <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: Current standard treatments for COVID-19 and laser acupuncture. 5-10 sessions of daily laser acupuncture using GaAlAs laser (810 nm). 5 points of the Kid-LI-SJ-Ren-Lung-Spleen-ST-BL-LIV meridians and the ear acupoints (Lung – Shenmen) will be irradiated with the following parameters respectively: 1) power: 400 mW, dose: 8 J at each acupuncture point, 2) power: 200 mW, dose: 2 J at each ear acupoint. Intervention 2: Current standard treatments for COVID-19. | IL-6 serum levels. Timepoint: Before the intervention and after the last session of laser acupuncture treatment. Method of measurement: IL-6 ELISA kit.;Percentage of lung involvement on CT-scan or chest x-ray. Timepoint: Before the intervention and after the last session of laser acupuncture treatment. Method of measurement: CT-scanner and portable x-ray unit.→Percentage of lung involvement on CT-scan or chest x-ray. Timepoint: Before the intervention and after the last session of laser acupuncture treatment. Method of measurement: CT-scanner and portable x-ray unit.;IL-6 serum levels. Timepoint: Before the intervention and after the last session of laser acupuncture treatment. Method of measurement: IL-6 ELISA kit. | | | | No | False | | |
| IRCT20201111049348N1 | 22 February 2021 | The Effect of Licorice Root Extract on the Treatment of Patients with Covid-19 | Comparison of the Effect of Alcoholic Extract of Licorice Root and Placebo Capsule on Alpha Tumor Necrosis Factor (TNF-a) Inflammatory Factor Interleukin-6 (IL-6) and Inflammatory Factor 1-Beta (IL-1ß) in Patients with Covid-19 | | Shahid Beheshti University of Medical Sciences | 2021-01-03 | 20210103 | IRCT | http://en.irct.ir/trial/52276 | Not Recruiting | No | 15 years | no limit | Both | 2021-01-29 | 120 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this research, the law of random allocation has been used. Thus, in the above study, with a sample size of 120 people, 60 balls for the intervention group (consumers of capsules containing licorice extract) with the title A and 60 balls for the control group (users of placebo capsules) with the title B were placed in a lottery container. And then randomly for each patient the balls are taken out of the container without replacement and the sequence created for each patient is recorded, Blinding description: Because the capsule containing licorice extract and the placebo are exactly the same color and size, patients and the research team are unaware of its contents, and only the treating physician knows which patient has taken which capsule. | 3 | Iran (Islamic Republic of) | Mrs Shokofe Noori | | Shahid Beheshti University of Medical Sciences , Koodkiar Street, Student Boulevard, Velenjak | shnoori85@yahoo.com | +98 21 2387 2570 | Shahid Beheshti University of Medical Sciences | Inclusion criteria: Includes people with laboratory confirmation of Quid 19 virus regardless of clinical signs and close association<br>Age over 15 years | Exclusion criteria: Patient request to leave the study for any reason<br>Request the treating physician to exclude the patient from the study for any reason<br>History of drug allergies<br>History of allergies<br>Patients with immunodeficiency<br>Patients with hypertension<br>Group of patients with underlying disease | People with COVID 19 whose disease has been confirmed by Real Time PCR. <br>U07.1 | Intervention 1: Consumption of capsules containing licorice extract in the intervention group.Alcoholic extract of licorice root will be purchased from Shirin Daroo Company and will be received in sterile packages. Prior to purchase, the manufacturer will receive a Certificate of Sale and Good Manufacturing Practice. The received sample will be sent to Zarband Pharmaceutical Company before the final order for glycyrrhizin content analysis and microbial test and the result of the analysis will be received. Alcoholic extract of licorice will be obtained from Shirin Daroo company along with COA product analysis sheet.Then, the sample will be sent to Zardband Pharmaceutical Company for confirmation of the mentioned parameters and final approval according to the standards mentioned in international pharmacopoeias. The extract will be added and mixed thoroughly. The powder obtained in the pharmaceutical factory (Osweh, Iran) will be packaged in an orange gelatin capsule (400 mg) and in a brown opaque can. Capsules containing licorice extract will be taken for one month in the amount of one capsule the day after lunch with a glass of water. Intervention 2: Control group: Placebo in capsules with the same color and size as the drug in cans similar to capsules containing licorice. Microcrystalline cellulose composition under the brand name AVICEL (particle diameter: less than 50 micrometers) as a placebo from the pharmaceutical company (Elixir , Iran) will be purchased. Placebo capsules will be taken for one month in the amount of one capsule per day after lunch with a glass of water. | Alpha tumor necrosis factor(TNF-a). Timepoint: Major measurements of variables are performed on the first day before the intervention and on the 10th day after the intervention. Method of measurement: Using the kit.;Interleukin One Beta( IL-1ß). Timepoint: Major measurements of variables are performed on the first day before the intervention and on the 10th day after the intervention. Method of measurement: Using the kit.;Interleukin 6( IL-6). Timepoint: Major measurements of variables are performed on the first day before the intervention and on the 10th day after the intervention. Method of measurement: Using the kit. | | | | Yes | False | | |
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| IRCT20210109049978N1 | 22 February 2021 | Effect of Internet- Based Psychoeducational Support on Perceived Stress and Caring Burden in Caregivers of Patients with COVID-19 | Effect of Internet- Based Psychoeducational Support on Perceived Stress and Caring Burden in Caregivers of Patients with COVID-19 | | Mashhad University of Medical Sciences | 2021-01-13 | 20210113 | IRCT | http://en.irct.ir/trial/53594 | Recruiting | No | 18 years | 60 years | Both | 2021-01-18 | 70 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Samples will be divided into intervention and control groups by random block allocation using quadruple blocks created by SPSS software version 24. According to the sample size of 70 in the present study, 18 quadruple blocks will be considered. Each caregiver will be randomly assigned to Group A (intervention) or B (control group) in the order determined by the software, and the sampling process will be performed sequentially until sampling is completed. Individuals are assigned to the target group in order of their entry into the study and randomly through randomized blocks. | N/A | Iran (Islamic Republic of) | Saeed Vaghee | | School of Nursing and Midwifery, Ibn Sina St.University St. | vaghees@mums.ac.ir | +98 51 3859 1511 | Mashhad University of Medical Sciences | Inclusion criteria: Caregiver age between 18-60.<br>No psychological disorders in the caregiver.<br>No drug addiction in the caregiver.<br>No hearing or vision impairment in the caregiver.<br>The caregiver should have the most contact with the patient in the post-discharge period.<br>Ability to access the Internet and online mass communication software.<br>Have the minimum ability to use smartphones and social networks.<br>Non-participation in other supportive interventions in the case of Covid-19.<br>The caregiver should not be a member of the health care system (such as doctors, nurses, midwives, etc.).<br>The caregiver is a family member of the patient. | Exclusion criteria: Do not participate in the post-test.<br>Absence from more than two sessions in support sessions.<br>The reluctance of caregiver in participate in the sessions. | COVID-19. <br>COVID-19, virus not identified;U07.1 | Intervention 1: Intervention group: For the intervention group, 6 sessions of 35 to 45 minutes per day will be held in the form of group video call (webinar) which will be held in the form of lectures, group discussions, questions and answers, slide shows and clips. Supportive content in the field of education: (Introduction of Covid-19, personal protective equipment, providing care for patient with COVID-19 at home after discharge, nutrition management during COVID-19 crisis, providing care for the elderly, children during the COVID-19 crisis, principles of infection control and Disinfection, warning signs of the disease in those around and the patient in the recovery period, the patient taking medications) and in the psychological field of stress management program according to the theoretical model of stress management Lazarus and Folkman (1- Stress education and its effective factors 2- Supporting caregivers in identifying Stressful dysfunctional thoughts 3- Providing coping strategies (problem-oriented and emotion-oriented) to deal with stress 4- Providing support in applying the support provided in daily life and patient care). Data collection tools included demographic information form, Cohen Standard Perceived Stress Questionnaire (PSS-14) and Zarit Burden Inventory Questionnaire (ZBI) which on the first day after discharge, before the first session in the intervention group by all caregivers ( Intervention and Control Group) will be completed online. After 14 days of completing the questionnaires, the mentioned questionnaires will be completed to measure the effectiveness of the intervention on the web. Intervention 2: Control group: They use the routine education of the medical center. Supporting contents will be provided to the control group after the interve | Caring Burden. Timepoint: At the beginning of the study (before the intervention) and 14 days later. Method of measurement: Zarit Burden Questionnaire.;Perceived Stress. Timepoint: At the beginning of the study (before the intervention) and 14 days later. Method of measurement: Cohen Perceived Stress Scale. | | | | Yes | False | | |
| → | IRCT20110425006280N11 | 22 February 2021 | The effect of pentoxifylline in the treatment of Covid-19 disease | Evaluation of pentoxifylline effect in treatment of patients with COVID-19, hospitalized in an intensive care unit, A randomized clinical trial | | Vice President of Research Guilan university of medical sciences | 2021-01-27 | 20210127 | IRCT | http://en.irct.ir/trial/53644 | Recruiting | No | 18 years | 75 years | Both | 2021-01-19 | 20 | interventional | Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients will be randomly admitted to each of the two treatment groups using the randomization method with a ratio of 1:1.
20 patients with Covid-19 disease will be divided into 2 groups of 10 intervention and control. The intervention group will be named A and the control group will be named B. Random blocking will be such that the patients will be assigned numbers 1 to 20, respectively. Then a table will be considered with 6 rows called blocks and each block with 4 parts and each part will be named A and B. In the next step, the numbers will be placed in each cell in order. After all the numbers are placed in the blocks, the people who had the number in house A will receive the intervention medicine and the people who had the number in house B will be considered as the control group.
The website https://www.sealedenvelope.com | 2 | Iran (Islamic Republic of) | Mohammad Haghighi | | Razi Hospital, Sardar Jangal Street, Rasht | manesthesist@gmail.com | +98 13 1322 3970 | Guilan University of Medical Sciences | Inclusion criteria: Patients with a clinical diagnosis of respiratory distress and dyspnea with SPAO2 less than 93% or positive PCR and radiographic test on CT SCANNING or Chest X-Ray admitted to the intensive care unit | Exclusion criteria: pregnant patients<br>patients who get under therapy for less than 3 days | The effect of pentoxifylline in the treatment of covid-19 disease. <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: This study is performed in critically ill patients with COVID-19 admitted to Razi Hospital after obtaining informed consent from the patient or their companions.The 10 eligible patients randomly selected will receive the national standard COVID-19 treatment regimen with pentoxifylline. The current standard treatment includes antiviral drug Remdesivir, a dose of 200 milligrams on the first day and then 100 milligrams for 5 days, which can be extended to 10 days depending on the clinical condition. The next drug is ReciGen, which is an interferon beta-1 drug. It is given to the patient at a dose of 44 micrograms subcutaneously for 5 days (every other day). The next drug is dexamethasone, which is a glucocorticoid and is given to the patient at a dose of 8 milligrams per day for 10 days. Heparin at a dose of 5000 units subcutaneous 3 times a day, pantoprazole at a dose of 40 milligrams once a day and vitamin C one gram twice a day will be considered for patients.The dose of pentoxifylline is 400 milligrams, which is determined based on creatinine clearance of the patient as follows: Creatinine clearance above 50 milliliters per minute: three times a day, creatinine clearance 10 to 50 milliliters per minute: twice a day, Creatinine clearance less than 10 milliliters per minute: once daily. The treatment period for patients is 14 days. For 14 days, they will be monitored daily for vital signs, electrolytes, blood sugar, liver tests, kidney tests, blood cells, coagulation factors, LDH, inflammatory factors, chest radiographs, and possible gastrointestinal complications. Finally, the two groups will be compared in terms of treatment effectiveness and possible side effects of treatment. Intervention 2: Control group: 10 patients receive the s | Percentage of oxygen saturation. Timepoint: Daily in the morning visit for 14 days. Method of measurement: Based on measurements with pulse oximetery.;Clinical signs of COVID-19 disease. Timepoint: Daily in the morning visit for 14 days. Method of measurement: Observe, measure and record fever, cough, shortness of breath, olfactory and taste disorders, headache, gastrointestinal symptoms, chills and .→Clinical signs of COVID-19 disease. Timepoint: Daily in the morning visit for 14 days. Method of measurement: Observe, measure and record fever, cough, shortness of breath, olfactory and taste disorders, headache, gastrointestinal symptoms, chills and .;Percentage of oxygen saturation. Timepoint: Daily in the morning visit for 14 days. Method of measurement: Based on measurements with pulse oximetery. | | | | No | False | | |
| IRCT20210111050011N1 | 22 February 2021 | The Effect of Tele-Nursing on Caregiver Burden in Family Caregivers and Self-Efficacy in Patients With Covid-19 | The Effect of Tele-Nursing on Caregiver Burden in Family Caregivers and Self-Efficacy in Patients With Covid-19 After Discharge From Hospitals | | Sabzevar University of Medical Sciences | 2021-02-16 | 20210216 | IRCT | http://en.irct.ir/trial/53741 | Recruiting | No | 30 years | 60 years | Both | 2021-02-19 | 60 | interventional | Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Samples will be selected by available methods and will be randomly assigned to intervention and control groups using random allocation blocks. R Software will be used to get the blocks. The blocks are made up of 4 English letters (A,B,C,D). A , and B will be considered for the intervention group, and other two letters (C, and D) will be considered for the control group. The blocks will be randomly selected in blindfolded manner. Each block will determine the order of entry in the intervention and control groups. Assuming choosing the DABC block means from left hand, first, and fourth, respectively, will be located in the control group, and the second, and third of participants will be located in the intervention group, respectively. Thus, fifteen blocks will be selected to complete the sampling, Blinding description: The study is sin | N/A | Iran (Islamic Republic of) | Ahmad Rajab Dizavandi | | School of Nursing and Midwifery, Campus of the University of Medical Sciences, above the Memorial of the Unknown Martyrs, Blvd of Nuclear Martyrs | ahmad.r.dizavandi@gmail.com | +98 51 3212 7476 | Sabzevar University of Medical Sciences | Inclusion criteria: Having informed consent to participate in the study<br>Age Over 30 Years and Maximum 60 Years<br>No Hearing Or Vision Disorders (Deaf And Dumb)<br>Lack of Clear Mental and Cognitive Impairment and Severe Mood-Emotional Disorder That Prevents Effective Communication<br>No Event Or a Stressful Event in The Last 6 Months for the Patient<br>Speak Persian or Understand Persian (Or Have a Companion Who Dominate in Persian)<br>Be Able To Read or Write (Or Have a Companion Him Literacy For Reading and Writing)<br>Patients living with Family<br>Patients in Live in House Quarantine<br>Failure To Participate in The Empowerment Program<br>Have a Diagnosis of Covid-19 (positive PCR test)<br>Having a Home Phone or Cell Phone<br>Be Careful<br>Have Experienced the Same Conditions for Covid-19 Disease. | Exclusion criteria: The Patient's Unwillingness To Participate in The Study | Coronavirus Disease (COVID-19). <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: In the Intervention Group, a 2-3 Hour Training Session is Held Under The Title of one-day Training Workshop Through Multimedia Software (Audio, Video, Image) and Related Platforms Including WhatsApp, Imo and Telegram, for Patients and Caregivers of the Same Patients. And training on the disease and ways to prevent its transmission, attention to quarantine time, location (features of the quarantine room, disinfection of the quarantine room, patient areas such as bathrooms and toilets), social communication, diet and medication In quarantine, psychological issues (psychological strategies for stress management), having a healthy lifestyle, sleeping and resting in quarantine, management of outpatient care (weakness and lethargy, fever and body aches, loss of sense of smell, nausea and vomiting, diarrhea, Ventilation, adequate nutrition, adequate fluids, providing minimum facilities for psychosocial support) are provided to the patient and caregiver. After That, in the Intervention group, Telephone Follow-up Will Be Done Daily for one Month in the First Two Weeks and Two Days in the Second Two Weeks. An Agreement is Reached Regarding Follow-up Times and Calls, and The Contact Number of The Researcher and WhatsApp, Imo, Telegram and SMS Media are Provided to the Participants so that They can Communicate and Ask their Questions Whenever Necessary. Depending on the Condition of the Caregiver and the Patient, and Depending on Which Stage of The Disease the Patient is in, There is Training and Related Care Appropriate to that Stage of the Disease, and If Necessary, the Patient is Referred to an Infectious Disease Specialist. Remote Nursing Recommendations are also Given to Prevent Infection Transmission, Patient Recovery, and Outpatient Proble | Self-Efficacy of Patients With Covid-19. Timepoint: Before and After one Month of Intervention. Method of measurement: Prevention, Recognition and Home-Management Self-Efficacy Scale (COVID-19-SES).;Caregiver Burden in Family Caregivers'. Timepoint: Before and After one Month of Intervention. Method of measurement: Novak and Guest Caregiver Burden Questionnaire (1989). | | | | Yes | False | | |
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| JPRN-UMIN000043256 | 22 February 2021 | Retrospective observational study to assess the impact of COVID 19 on emergency care in Niigata city | Retrospective observational study to assess the impact of COVID 19 on emergency care in Niigata city - Impact of COVID 19 on emergency care | | Niigata university | 05/02/2021 | 20210205 | JPRN | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049370 | Not Recruiting | No | Not applicable | Not applicable | Male and Female | 2021/02/15 | 18000 | Observational | Not selected Not selected | Not selected | Japan | Shinya | Fujiki | 1-757 Asahimachidori, Chuo-ku, Niigata | sfujiki@med.niigata-u.ac.jp | 025-227-2185 | Niigata University Graduate School of Medical and Dental Sciences Department of Cardiovascular Biology and Medicine | Inclusion criteria: | Exclusion criteria: None | Patients who received emergency medical care at participating medical institutions | | Number of patients at Niigata City Emergency Medical Center | | 31/03/2025 | | Yes | False | | |
| → | CTRI/2021/01/030789 | 23 February 2021 | Evaluation of different complete blood count(CBC) parameters in prognosis of COVID -19 patients | Evaluation of Hematological parameters as prognostic indicators in COVID -19 patients | | KIMS Hospital | 27-01-2021 | 20210127 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50967 | Not Recruiting | No | | | | 29-01-2021 | 100 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sarojini Raman→ | | Department Of Pathology,
KIMS,Campus-5
KIIT University
BBSR → | sarojini.raman@kims.ac.in→ | 7077288117→ | Kalinga Institute of Medical Sciences,Bhubaneswar→ | Inclusion criteria: 1)ALL RT-PCR POSITIVE COVID-19 PATIENTS→ | Exclusion criteria: 1)All COVID unrelated cases . <br/ ><br>2)Patients in which proper clinical details missing→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | These parameters are expected to act as indicators of immune status of patient, hyperinflammatory and cytokine storm status, indicators of superinfection , disease severity and extent of systemic inflammationTimepoint: The parameters will be assessed at the time of admission and at the time of discharge in case of general ward patients and at 1 week interval in case of ICU patients→ | | | | Yes | False | | |
| → | CTRI/2021/01/030782 | 23 February 2021 | COVID-19 Vaccine effectiveness and hesitancy study in Healthcare Workers of Max Group of Hospitals | â??A prospective, longitudinal, observational, postlicensure vaccine evaluation study to assess the effectiveness of COVID-19 vaccine among the Healthcare workers of Max group of hospitalsâ?? | | CSIRInstitute of Genomics and Integrative Biology | 27-01-2021 | 20210127 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52014 | Not Recruiting | No | | | | 05-02-2021 | 1000 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sujeet Jha→ | | Institute of Endocrinology, Diabetes, and Metabolism, Max Super Speciality Hospital, 2, Press Enclave Road, Saket → | sujeet.jha@maxhealthcare.com→ | 9910609000→ | Max Healthcare→ | Inclusion criteria: â?¢ HCWs of Max group of hospitals, irrespective of age and gender <br/ ><br>â?¢ HCWs who are being offered Govt. of India approved COVID-19 vaccines Covishield or COVAXIN <br/ ><br>→ | Exclusion criteria: Refusal to give informed consent, or contraindication to venipuncture.→ | | Intervention1: Not applicable: Not applicable<br>→ | Seropositivity in participants after vaccinationTimepoint: 7, 14, 28, 45, 90 days after vaccination, may be extended further→ | | | | Yes | False | | |
| → | CTRI/2021/01/030752 | 23 February 2021 | Effect of Online Yoga for 12-weeks in comparison to no-treatment on change in Burnout and Professional Quality of Life among COVID-19 Frontline Warriors. | Efficacy of mHealth aided 12-week Rhythmic-Yoga-
Breathing Intervention on change in Burnout and Professional Quality of Life among Health Care Providers at a Tertiary Care Hospital during COVID-19 pandemic: A Randomized Waitlist-Controlled Trial. | | Department of Science and Technology DST SATYAM Science And Technology of Yoga And Meditationy | 27-01-2021 | 20210127 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51380 | Not Recruiting | No | | | | 30-01-2021 | 90 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable | N/A | India→ | Dr Monika Pathania→ | | Associate Professor, Dept. of General Medicine, Level-6, Medical College Block-A, All India Institute of Medical Sciences, Near Barrage, Pashulok, Rishikesh - 249203. → | anshupathania27@gmail.com→ | 8126021556→ | All India Institute of Medical Sciences, Rishikesh→ | Inclusion criteria: Inclusion Criteria: <br/ ><br>1. Health care providers at AIIMS Rishikesh (working for at least 6 months) <br/ ><br>2. Within age group of 18 to 65 years <br/ ><br>3. Willing to commit to at least 75% of total intervention period <br/ ><br>4. Having a Smartphone device to avail mHealth aided intervention and home practice sessions <br/ ><br>5. Willing to be wait-listed if allocated to the control arm.→ | Exclusion criteria: Exclusion Criteria: <br/ ><br>1. Already practicing some form of yoga/meditation for more than 1 month in the previous 6 months <br/ ><br>2. Unable to practice yoga due to: musculoskeletal disorders, severe cervical pain, severe back pain or arthritis <br/ ><br>3. Having medical conditions like epilepsy, migraine, or any psychiatric disorder <br/ ><br>4. Pregnant women <br/ ><br>5. Not willing to provide a written informed consent→ | | Intervention1: mHealth aided rhythmic-yoga-breathing intervention for 12-weeks: The 12-weeks long mHealth aided rhythmic-yoga-breathing intervention will have 3 main Components:<br><br><br>1. Online 4-day orientation program: The initial 4-day orientation program will be led online by research staff cum yoga Instructor using a Smartphone based video conferencing app, with 2 hours spent per day, consisting of interactive sessions, knowledge sharing, and initiation to the rhythmic-yoga-breathing with practical demonstration along with home going instructions for daily home practice on the last day.<br><br><br>2. Daily short rhythmic-yogic-breathing practice at home: Daily home practice session will last 30-40 minutes each and will be assisted by a mobile app installed on the participantâ??s Smartphone device. Compliance to daily practice will also be checked using the daily practice log provided in the same app.<br><br><br>3. Weekly online follow-up sessions: In the weekly follow up sessions, participants will undergo group sessions of rhythmic-yoga-breathing with longer duration than daily practice and will get an opportunity to express their views and provide feedback about the course and experiences felt during the practice. During each weekly follow up session, the yoga Instructor will reinforce regular practice of rhythmic-yoga-breathing and also check participantâ??s compliance to daily practice along with clarifying any doubts regarding the practice or using the mobile application.<br><br>A minimum of 75% adherence to the Rhythmic-Yoga-Breathing intervention will be required from the participants to qualify for final assessment.<br>Control Intervention1: Wait-List Control: No specific Intervention will be given to control arm. Participants in this arm will be asked to continue with their daily routin→ | Primary Outcome Variables: <br/ ><br>1. Maslach Burnout Inventory scores- evaluated on three dimensions: <br/ ><br>a.Emotional Exhaustion <br/ ><br>b.Depersonalisation <br/ ><br>c.Personal Accomplishment <br/ ><br> <br/ ><br>2. Professional Quality of Life (Pro QOL) scores- evaluated on two dimensions: <br/ ><br>a.Compassion Satisfaction <br/ ><br>b.Compassion Fatigue: Burnout & Secondary Traumatic StressTimepoint: Baseline (after participant enrollment) <br/ ><br>Endpoint (after 12 weeks of intervention)→ | | | | Yes | False | | |
| → | CTRI/2021/01/030788 | 23 February 2021 | Prevalence of arrhythmia in COVID 19 patients | Prevalence of arrhythmia among COVID 19 patients with mild/moderate and severe illness - PARIC-19 | | Vardhman mahavir medical college and safdarjung hospital | 27-01-2021 | 20210127 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50911 | Not Recruiting | No | | | | 01-02-2021 | 124 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | PRAVEEN GUPTA→ | | Department of Cardiology, Vardhman Mahavir Medical College and safdarjung hospital Ansari Nagar East near to AIIMS Metro Station New Delhi Delhi 110029 → | praveenkumargupta2002@gmail.com→ | 8072561057→ | Vardhman Mahavir Medical College & safdarjung hospital→ | Inclusion criteria: COVID 19 patients who are admitted to the hospital→ | Exclusion criteria: 1) Age less than 12 years, <br/ ><br>2) COVID 19 patients whose severity changes during hospital admission <br/ ><br>3) Patient who are pacemaker dependent with fully paced rhythm <br/ ><br>4) Patients on hydroxychloroquine <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | The prevalence of arrhythmia in COVID 19 patients who are admitted to the hospitalTimepoint: Baseline and at 4 week→ | | | | Yes | False | | |
| → | CTRI/2021/01/030796 | 23 February 2021 | A simple test for COVID-19 immunity | Evaluation of Cellular Immunity in SARS-CoV-2 recovered subjects as an alternative to IgG testing - NIL | | Atrimed Biotech LLP | 28-01-2021 | 20210128 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51818 | Not Recruiting | No | | | | 01-02-2021 | 60 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Hrishikesh Damle→ | | EFF5, Bangalore Bioinnovation Centre
Helix Biotech Park
Electronic City phase 1
Bangalore → | shiv_shankar@hotmail.com→ | 9632469944→ | Indoor Biotechnologies India Pvt. Ltd.→ | Inclusion criteria: 1) Both male and female adult populations aged from 18 to 60 years with background comorbidities such as Type II Diabetes mellitus(DM), hypertension(HTN), Bronchial asthma, Ischemic heart disease(IHD), cerebrovascular accidents(CVA), Thyroid disorders will be included in the study. <br/ ><br>2) Convalescent, RTPCR negative for SARS-CoV2 ( 2 weeks), IgG positive for SARS CoV2 , asymptomatic patients as determined by the principal investigator/ physician. <br/ ><br>3) SARS CoV2 frontline workers are included as test subjects. <br/ ><br>4) Non health care workers are included as control subjects. 5) Volunteer is willing and able to comply with all the trial requirements. 5) All volunteers obtained written informed consent form in English as well as native language, Kannada→ | Exclusion criteria: 1) Patients with active COVID-19 infection( PCR positive, IgM positive). <br/ ><br>2) Known patients of HIV, Hepatitis-B/C , H1N1. <br/ ><br>3) Pregnant and lactating women. <br/ ><br>4) Patients with known autoimmune diseases on immuno-suppressants and steroids. <br/ ><br>5) Patients who have participated in another clinical trial within the previous 30 days. <br/ ><br>6) Patient not willing to give informed consent form→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | COVID-19 T-cell immunity positive or negativeTimepoint: within 1 week of COVID-19 negative PCR test or 3 weeks after COVID-19 active infection→ | | | | Yes | False | | |
| → | CTRI/2021/01/030795 | 23 February 2021 | Clinical study to evaluate the safety and efficacy of ATRICOV 452 for the treatment of COVID-19 along with the standard of care. | A Single blind, randomized, placebo-controlled, exploratory clinical study to evaluate the safety and efficacy of ATRICOV 452 for the treatment of COVID-19 along with the standard of care. | | Atrimed Pharmaceutical Pvt Ltd | 28-01-2021 | 20210128 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51391 | Recruiting | No | | | | 01-02-2021 | 100 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Investigator Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Investigator Blinded | Phase 2 | India→ | Dr Harish S→ | | #16 & 18 ICBio Tower
Yelahanka Main Road
Chikkabettahalli
Vidyaranyapura
→ | harish@icbiocro.com→ | 9900111997→ | ICBio Clinical Research Pvt. Ltd.→ | Inclusion criteria: 1.Both male and female adult populations aged from 18 to 60 years will be included in the study. <br/ ><br>2.Confirmed RT-PCR positive for SARS CoV-2 and IgG â??ve symptomatic patients as determined by the principal investigator/ Physician. <br/ ><br>3.Controlled Diabetes (Type 2 DM (Hb1Ac < 7) and Hypertension (Systolic BP <140 mm Hg or diastolic BP <90 mm Hg). <br/ ><br>4.Patient with BMI from â?¥18 to â?¤ 30 are included. <br/ ><br>5.Patient is willing and able to comply with all trial requirements. <br/ ><br> All the patients obtained written informed <br/ ><br> consent form in English as well as native <br/ ><br> language, according to national regulations. <br/ ><br>→ | Exclusion criteria: 1.If the physician finds vulnerability based on the history, nutritional status, physical appearance, or any other reason. <br/ ><br>2.Judgment of the physician on likely need of ICU admission. <br/ ><br>3.Known hepatic & kidney disease. <br/ ><br>4.Known hypersensitivity to usual standard of care drug. <br/ ><br>5.Known patient of cardiovascular disease, including congenital and ischemic heart disease, congestive cardiac failure. <br/ ><br>6.Uncontrolled Type 2 DM (Hb1Ac >7), Insulin dependent DM & Uncontrolled HTN (systolic BPâ?¥140 mm Hg or diastolic BPâ?¥90 mm Hg. <br/ ><br>7.Patients with BMI <18 and > 30 (Obese) are not included in the study. <br/ ><br>8.Hemoglobin < 8 gm/dl are excluded. <br/ ><br>9.Known patient of HIV or on any other anti-viral medication for a disease other than Covid-19. <br/ ><br>10.Pregnant and lactating women. <br/ ><br>11.Presence of debilitating diseases like Tuberculosis, Rheumatoid arthritis, Carcinoma, Known case of inflammatory autoimmune diseases of any kind, neurodemyelinating diseases like Multiple sclerosis, Transverse myelitis, Thyroid, adrenal, pituitary endocrine disorders, Renal failure, Inflammatory bowel disease. <br/ ><br>12.Patients who had participated in another clinical trial with in the previous 30 days. <br/ ><br>13.Patients under immune suppressants and steroid (steroid for any other disease than Covid-19). <br/ ><br>14.Signs and symptoms, haematological, imaging investigations show signs of severe COVID will be excluded. <br/ ><br>15.Any other medical conditions that is considered as unsuitable for the study by investigator. <br/ ><br>16.Patient is not willing to give inform consent form. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ATRICOV 452: ATRICOV 452 (500mg) 2 capsules TID for 14 days + standard of care<br>Control Intervention1: Placebo of ATRICOV 452: Placebo of ATRICOV 452 (500mg) 2 capsules TID for 14 days + standard of care<br>→ | 1.Time taken for clinical resolution of signs and symptom <br/ ><br>2.Time taken for the conversion of COVID +ve to COVID -ve of throat swabs <br/ ><br>3. Change in Disease progress markersTimepoint: From screening to 14 days→ | | | | Yes | False | | |
| → | CTRI/2021/01/030794 | 23 February 2021 | Is there a difference in outcome of patients undergoing surgery after recovery from COVID 19. A multicentre study in India.
| A national multi-centre observational case control study on the 30-day morbidity and mortality of abdominal surgical procedures in patients recovered from SARS CoV-2 infection: IAGES Collaborative Study
- COVIDIAGES | | IAGES Indian Association of GastroEndoscopic Surgeons | 28-01-2021 | 20210128 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50368 | Not Recruiting | No | | | | 01-02-2021 | 442 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | pankaj bansal→ | | SIDSS Office , III floor , IPD building , Santokba Durlabhji Memorial Hospital , Jaipur Bhawani Singh Marg→ | bhojwani@docsindia.in→ | 9829176755→ | Santokba DurlabhJi Memorial Hospital→ | Inclusion criteria: Abdominal surgical procedures including colorectal surgery, general surgery, hepatobiliary surgery, oesophagogastric surgery, transplant surgery, trauma surgery and abdominal vascular surgery. <br/ ><br>Day care surgery and inpatient surgery are included. <br/ ><br>All consecutive patients, more than or equal to 18 years , operated from the date of study initiation need to included regardless of emergency or elective status, major or minor status , minimal invasive or open status , day care or indoor admission status , and, irrespective of the seniority of the operating surgeon. <br/ ><br>All the patients have to mandatorily have the immediate pre-op (within 72 hours) RT PCR Swab test for SARS CoV-2 infection. <br/ ><br>All patients undergoing abdominal surgery in an operation theatre regardless of the mode of anaesthesia â?? General, Spinal, Epidural, Regional, or Local. <br/ ><br>→ | Exclusion criteria: EXCLUSION CRITERIA FOR PATIENTS: <br/ ><br>All patients < 18 years of age. <br/ ><br>Patients undergoing gynaecological or urological procedures. <br/ ><br>Patients undergoing procedures outside of an operation theatre setting. <br/ ><br>Patients undergoing an emergency operation with undetermined SARS CoV-2 infection exposure status preoperatively, but test results determined post operatively establish the infected status (postoperative RT PCR swab test positive). <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Control Intervention1: NIL: NIL<br>→ | To determine the 30-day morbidity and mortality of in those patients who were previously exposed to SARS CoV-2 infection and nare now undergoing major abdominal surgery in India. <br/ ><br>Timepoint: 30 days→ | | | | Yes | False | | |
| → | CTRI/2021/01/030793 | 23 February 2021 | A clinical trial of Intravenous Glutathione along with standard treatment in Moderate COVID-19 Pneumonia Patients. | A Multi-centric, Comparative, Randomized, Double-blind, Placebo-controlled, Proof of concept trial to evaluate the Efficacy and Safety of Intravenous Glutathione, as an add-on to the â??Standard of Careâ?? in Moderate COVID-19 Pneumonia Patients. | | Zuventus Healthcare Limited | 28-01-2021 | 20210128 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48850 | Recruiting | No | | | | 30-01-2021 | 240 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Dr Bhupesh Dewan→ | | Department of Medical Services, 3101, C Wing, Oberoi Garden Estate, Chandivali, Andheri (E) → | Bhupesh.Dewan@zuventus.com→ | 022-30610000→ | Zuventus Healthcare Limited→ | Inclusion criteria: 1. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR. <br/ ><br>2. Patients with moderate COVID-19 (According to Clinical Management Protocol: COVID 19, Govt. of India). <br/ ><br>-Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air <br/ ><br>-Respiratory Rate â?¥24 per minute <br/ ><br>-Pneumonia with no signs of severe disease <br/ ><br>3. Symptomatic adult male or non-pregnant female (â?¥18 years) <br/ ><br>4. Voluntarily participating in the clinical study and patients or legal representative willing to sign informed consent.→ | Exclusion criteria: 1. Asymptomatic COVID-19 patients. <br/ ><br>2. Patients with known hypersensitivity to glutathione or related drugs. <br/ ><br>3. Patients enrolled in any other investigational drug studies in COVID-19. <br/ ><br>4. Severe infection and need for invasive or non-invasive ventilator support. <br/ ><br>5. Pregnant or lactating women→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Glutathione 600 mg with Standard of Care: Patients will receive 2400 mg of intervention product as a loading dose and then 1200mg every 12 hourly for 7 days as an intravenous injection. Standard of Care will be as per individual Hospital protocol. It will be kept as close to the government treatment protocol as possible.<br>Control Intervention1: Placebo with Standard of Care: Placebo will be used as the control and will be administered every 12 hours for 7 days as an intravenous injection. Standard of Care will be as per individual Hospital protocol. It will be kept as close to the government treatment protocol as possible.<br>→ | Proportion of patients showing clinical improvement on the WHO 7-point ordinal scale.Timepoint: Day 1, 2, 3, 4, 5, 6 and 7→ | | | | Yes | False | | |
| → | CTRI/2021/01/030816 | 23 February 2021 | EAR,NOSE AND THROAT SYMPTOMS PERSISTING AFTER PATIENTS RECOVERED FROM COVID-19 OR LONG TERM CONSEQUENCES OF THE DISEASE | Post COVID-19 ENT manifestations-An institutional based prospective study. | | DrDebasis Jena | 28-01-2021 | 20210128 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51937 | Not Recruiting | No | | | | 05-02-2021 | 250 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrDebasis Jena→ | | Department of ENT, Kalinga Institute of Medical Sciences KIIT University Patia Bhubaneswar → | drdebasisent@gmail.com→ | 9439874783→ | Kalinga Institute of Medical Sciences Patia Bhubaneswar→ | Inclusion criteria: Patients tested positive for Covid-19 three weeks before and recovered→ | Exclusion criteria: Patient who are not willing to participate in the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To detect, analyze and discuss the different ear nose throat (ENT) manifestations in COVID-19 recovered patients.Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/01/030826 | 23 February 2021 | Clinical virtual simulation is effective in nursing education | Virtual simulation in Nursing Education: A Randomised Controlled trial during Covid-19 crisis period | | AIIMS intramural grant | 29-01-2021 | 20210129 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47638 | Not Recruiting | No | | | | 01-04-2021 | 52 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shashi Mawar→ | | Room No 2, Porta Cabin, College Of Nursing, AIIMS, Ansari Nagar → | drshashimawar@gmail.com→ | 8800228317→ | AIIMS, Delhi→ | Inclusion criteria: Nursing students enrolled for PG program at AIIMS college of Nursing.→ | Exclusion criteria: Students not consenting for study→ | | Intervention1: Virtual clinical simulation: Its a type of touch screen physiological algorithm for various clinical situations which students will operate based on their clinical reasoning. The virtual patient will respond as per the students decisions. The student will either be able to successfully manage the patient or will not and then provide feedback as per the performance.<br><br>Control Intervention1: Low technology simulation: Control group will be provided similar clinical scenarios in lab settings and will be performing the management based on their understanding. Inputs will be provided only if asked.<br>→ | Knowledge based clinical reasoningTimepoint: Baseline, Post intervention Day 1 and 3 months later.→ | | | | Yes | False | | |
| → | CTRI/2021/01/030829 | 23 February 2021 | Effectiveness of HFNC Vs non rebreathing mask for oxygen therapy in COVID 19 pneumonia | Randomized Controlled Trial to evaluate the effectiveness of HFNC and standard non-rebreathing mask for oxygen therapy in moderate category COVID 19 pneumonia | | Government Institute of Medical Sciences | 29-01-2021 | 20210129 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51297 | Not Recruiting | No | | | | 05-02-2021 | 30 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Dr Nazia Nazir→ | | Department of Anaesthesia and Critical Care, COVID ICU, GIMS GIMS, Kasna, Greater Noida→ | nazunazir@gmail.com→ | | Government Institute of Medical sciences→ | Inclusion criteria: Pneumonia with no signs of severe disease with <br/ ><br>Clinical features of dyspnoea, hypoxia, fever, cough <br/ ><br>Spo2-â?¤94% (range 90-94%) on room air & RR of 24-30/ min <br/ ><br>→ | Exclusion criteria: Patients in severe category of COVID 19→ | Health Condition 1: J962- Acute and chronic respiratory failure
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: High Flow Nasal Cannula (HFNC) group: Group 1 will comprise of patients treated with High flow Nasal cannula. <br>HFNC set at 40-60 L/mt , FiO2- 0.8-1adjusted to maintain SpO2 SpO2 â?¥ 96- 99 %. Duration of therapy- till the patient improves or goes into severe category of COVID<br>Control Intervention1: standard non-rebreathing mask (NRBM)group: Group 2 will comprise patients treated with standard non-rebreathing mask. NRBM will be used at a flow rate of 12-15 L/mt FiO2- 0.8-1, adjusted to maintain SpO2 â?¥ 96- 99%.<br>Duration of therapy- till the patient improves or goes into severe category of COVID<br>→ | Primary outcomes noted will be number of patients and time to progression to severe disease.Timepoint: 0,1,2 to 14 days→ | | | | Yes | False | | |
| → | CTRI/2021/01/030830 | 23 February 2021 | Therapeutics for Inpatients with COVID-19 (TICO) | A Multicenter, Adaptive, Randomized, Blinded Controlled Trial
of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients with COVID-19 - Therapeutics for Inpatients with COVID-19 (TICO) | | National Institute of Allergy and Infectious Diseases NIAID National Institutes of Health NIH | 29-01-2021 | 20210129 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52067 | Not Recruiting | No | | | | 08-02-2021 | 1000 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Participant and Investigator Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Participant and Investigator Blinded | Phase 3 | Argentina;Australia;Brazil;Chile;Denmark;France;Georgia;Germany;Greece;India;Israel;Japan;Mexico;Nigeria;Peru;Poland;Portugal;Singapore;Spain;Sweden;Switzerland;Thailand;United Kingdom;United States of America→ | DrNKumarasamy→ | | VHS-Infectious Diseases Medical Centre Department, Chennai Antiviral Research and Treatment(CART)CRS,Voluntary Health Services Hospital, Rajiv Gandhi Salai, Taramani, Chennai- 600113 → | kumarasamy@cartcrs.org→ | 9176912007→ | VHS-Infectious Diseases Medical Centre→ | Inclusion criteria: 1. Age more than or equal to 18 years <br/ ><br>2. Informed consent by the patient or the patientâ??s legally-authorized representative <br/ ><br>(LAR) <br/ ><br>3. SARS-CoV-2 infection, documented by a nucleic acid test (NAT) or equivalent testing <br/ ><br>within 3 days prior to randomization OR documented by NAT or equivalent testing more <br/ ><br>than 3 days prior to randomization AND progressive disease suggestive of ongoing <br/ ><br>SARS-CoV-2 infection per the responsible investigator (For non-NAT tests, only those <br/ ><br>deemed with equivalent specificity to NAT by the protocol team will be allowed. A <br/ ><br>central list of allowed non-NAT tests will be maintained.)→ | Exclusion criteria: 1. Prior receipt of Any SARS-CoV-2 hIVIG, convalescent plasma from a person who recovered from <br/ ><br>COVID-19 or SARS-CoV-2 nMAb at any time prior to hospitalization; <br/ ><br>2. Not willing to abstain from participation in other COVID-19 treatment trials until after Day <br/ ><br>5 (with the approval of study leadership, enrollment before or on Day 5 is permitted for <br/ ><br>trials comparing different approaches for implementing SOC interventions <br/ ><br>3. In the opinion of the responsible investigator, any condition for which, participation <br/ ><br>would not be in the best interest of the participant or that could limit protocol specified <br/ ><br>assessments; <br/ ><br>4. Expected inability to participate in study procedures; <br/ ><br>5. Women of child-bearing potential who are not already pregnant at study entry and who <br/ ><br>are unwilling to acknowledge the strong advice to abstain from sexual intercourse with <br/ ><br>men or practice appropriate contraception through 18 months of the study. <br/ ><br>6. Men who are unwilling to acknowledge the strong advice to abstain from sexual <br/ ><br>intercourse with women of child-bearing potential or to use barrier contraception through <br/ ><br>18 months of the study. <br/ ><br>Prior to the initial futility assessment for an investigational agent, the following two <br/ ><br>additional exclusions (7 and 8) which define disease severity stratum 2 apply: <br/ ><br>7. Presence at enrollment of any of the following: <br/ ><br>a. stroke <br/ ><br>b. meningitis <br/ ><br>c. encephalitis <br/ ><br>d. myelitis <br/ ><br>e. myocardial infarction <br/ ><br>f. myocarditis <br/ ><br>g. pericarditis <br/ ><br>h. symptomatic CHF (NYHA class III-IV) <br/ ><br>i. arterial or deep venous thrombosis or pulmonary embolism <br/ ><br>8. Current requirement for any of the following: <br/ ><br>a. invasive mechanical ventilation <br/ ><br>b. ECMO <br/ ><br>c. mechanical circulatory support <br/ ><br>d. vasopressor therapy <br/ ><br>e. commencement of renal replacement therapy at this admission (i.e. not patients <br/ ><br>on chronic renal replacement therapy).→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: BRII-196 and BRII-198: 1000 mg Intravenous Infusion single dose only<br><br>Treatment Duration is SINGLE DOSE ONLY<br>Intervention2: VIR-7831: 500 mg Intravenous Infusion single dose only <br>Treatment Duration is SINGLE DOSE ONLY<br>Control Intervention1: Standard of care treatament and Remdesivir: Standard of care treatment and Inj. Remdesivir 200mg IV once daily on Day1 and 100mg IV once daily from Day2-10.<br>Treatment Duration is 10 Days<br>→ | Is time from randomization to sustained recovery, defined as <br/ ><br>being discharged from the index hospitalization, followed by being alive and home for 14 <br/ ><br>consecutive days prior to Day 90.Timepoint: Day 0,1,2,3,4,5,6,7,14,28, 42,60,75 and 90. Month 6,12 and 18→ | | | | Yes | False | | |
| → | CTRI/2021/01/030825 | 23 February 2021 | Role of Unani drugs (Tiryaqe Wabai, Arque-e-Ajeeb, Habb-e- Loban) in the treatment of COVID-19 patients. | Adjuvant role of Unani formulations (Tiryaqe Wabai, Arque-e-Ajeeb, Habb-e- Loban) in the management of COVID-19 patients | | Ministry of AYUSH | 29-01-2021 | 20210129 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51863 | Not Recruiting | No | | | | 01-02-2021 | 46 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3 | India→ | Dr Ansul Kumar→ | | ROOM NO 19,
SUPER SPECIALITY BUILDING,
RIMS,BARIATU
RANCHI → | docansul@gmail.com→ | 9650965875→ | Department of Cardiothoracic Surgery, RIMS→ | Inclusion criteria: American Society of Anesthesiologists (ASA) class I &II. <br/ ><br>Confirmed COVID-19 case (RT-PCR for SARS-CoV-2 positive). <br/ ><br>→ | Exclusion criteria: Patient not consenting. <br/ ><br>Suspected COVID patient. <br/ ><br>American Society of Anesthesiologists (ASA) class III, IV & V. <br/ ><br>Pregnant and lactating women. <br/ ><br>History of Hypersensitivity/non-responsive to the study drug or any of its ingredients.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Treatment with Tiryaqe Wabai, <br>Arque-e Ajeeb and<br>Habb-e- Loban<br>: All the patients will receive treatment according to the standard treatment protocol of COVID-19 based on Ministry of Health and Family Welfare (MoHFW), Government of India guidelines, which include Antipyretics (Tab Paracetamol 500 mg PO SOS), Tab Doxycycline 200 mg BD, Tab Ivermectin 12 mg OD, Tab Vitamin C 500 mg TDS, Vitamin D Sachet (60k) weekly, Tab Zinc 50 mg OD, Tab Multivitamin OD. Apart from that patient will receive Tiryaqe Wabai 2g OD, Arque-e Ajeeb 2 nasal drops 4 times per day and <br>Habb-e- Loban 125 mg BD. Total duration of trial therapy will be 45 days.<br>Intervention2: Tiryaq Wabai: Treatment according to the standard treatment protocol of COVID-19 based on Ministry of Health and Family Welfare (MoHFW), Government of India plus Tiryaqe Wabai, a Unani formulation consists of three ingredients Sibr (Aloe barbadensis), Zaafran (Crocus sativus) and Mur (Commiphora myrrh). Dosage is orally 2g OD for 45 days.<br>Intervention3: Arque-e Ajeeb: Treatment according to the standard treatment protocol of COVID-19 based on Ministry of Health and Family Welfare (MoHFW), Government of India plus Arque-e-Ajeeb, a Unani formulation consists of Sat. Ajwain, Sat. Podina and Sat Kafoor (NFUM vol-I, page 211). Dosage is 2 nasal drops 4 times per day and duration is up to discharge from hospital.<br>Intervention4: Habb-e-Loban: Treatment according to the standard treatment protocol of COVID-19 based on Ministry of Health and Family Welfare (MoHFW), Government of India plus Habb-e-Loban, a Unani formulation made with the ingredients - Kundur (Boswellia serrata Roxb.ex Colebr), Aarad Baqla (Vicia faba L.), Maghz-e-Behidana (Cydonia oblonga Mill.), Rubb-us-Soos (Glycyrrhiza glabra L.), Kateera (Cochlospermum→ | Proportion of patients with 50% increase in mean ALC on day 14Timepoint: Day 15→ | | | | Yes | False | | |
| → | CTRI/2021/01/030824 | 23 February 2021 | Efficacy and Safety Study of COVID-19 Hyperimmunoglobulin in patients with COVID-19 | An Open-Label, Randomized, Controlled, Multicenter Study to evaluate the Efficacy and Safety of COVID-19 Hyperimmunoglobulin in Patients with COVID-19 | | Virchow Biotech Private Limited | 29-01-2021 | 20210129 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50900 | Recruiting | No | | | | 29-01-2021 | 66 | Interventional | Randomized, Parallel Group, Multiple Arm Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable→Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Hemanth Nandigala→ | | Virchow Biotech Private Limited Room Number 1, East Avenue Buliding, plot number 319 and
320,AyyappaSociety Madhapur
Hyderabad
TELANGANA→ | hnandigala@gmail.com→ | 04023119481→ | Virchow Biotech Private Limited→ | Inclusion criteria: 1.Male and female patients â?¥18 and â?¤65 years with active COVID-19 confirmed by RT-PCR, within less than 72 hours prior to randomization; <br/ ><br>2.Participants with moderate to severe active COVID-19 (Clinical Management of COVID-19 Guidelines of MOHFW) at screening and baseline defined as: <br/ ><br>a)Radiological evidence of pulmonary infiltrates or Clinical features such as dyspnea and/or hypoxia, fever, cough, AND <br/ ><br>b)SpO2 of <93 % on room air AND <br/ ><br>c)Respiratory rate of â?¥24 per minute <br/ ><br>3.Women of childbearing potential agreeing to use of adequate contraception till study completion at a minimum 30 days until after the last dose of study intervention <br/ ><br>4.Male participants are eligible if they agree to use contraception /barrier during sexual activities or donation of sperm for the purpose of reproduction PLUS, during the study and till 90 days completion of the study. <br/ ><br>5.Participants who are willing to give the consent to particate in the trial. <br/ ><br>→ | Exclusion criteria: 1.Participants either with asymptomatic or who are high risk with COVID-19 as per latest (MOHFW guideline) and as per assertion of investigator own decision at screening and at baseline. <br/ ><br>2.Participants are not suitable for immunoglobulin therapy and history of known IgA deficiency. <br/ ><br>3.Participants with known major illness/organ transplantation/major surgeries during six months before the day of screening. <br/ ><br>4.Participants with more than five days of COVID-19 specific hospitalization prior to treatment at baseline <br/ ><br>5.Confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline. <br/ ><br>6.Participants whose ALT/AST levels are 5 times higher than the normal upper limit and total bilirubin is 3 times higher than the upper limit of normal and Creatinine clearance less than 50 mL/min using the Cockcroft-Gault formula. <br/ ><br>7.Participation in other studies and have received investigational intervention 30 days or 5 half-lives (whichever is longer) before the signing the consent. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Hyperimmunoglobulin 50 mg/kg: Participants will receive a dose of50 mg/kg body weight of COVID-19 hyperimmunoglobulin by intravenous route at the rate of not more than 0.5mL/kg/h on Day 1. This dose will be administered through a separate IV line.In addition to hyperimmunoglobulin patients will receive Standard of Care<br>Intervention2: Hyperimmunoglobulin 75 mg/kg: Participants will receive a dose of 75 mg/kg body weight of COVID-19 hyperimmunoglobulin by intravenous route at the rate of not more than 0.5mL/kg/h on Day 1. This dose will be administered through a separate IV line.In addition to hyperimmunoglobulin patients will receive Standard of Care<br>Control Intervention1: Standard of Care: Standard of care is the treatment algorithm/modalities to be given at discretion of the investigator as defined in the latest Guidelines on Clinical Management of COVID-19 issued by Ministry of Health and Family Welfare, Government of India, as on date<br>→ | Mean change in 8 point ordinal scale in clinical improvement from baseline to day 8Timepoint: Day 8→ | | | | Yes | False | | |
| → | CTRI/2021/01/030843 | 23 February 2021 | Daily life Experiences as such distress, violence and coping of Wives of persons with Alcohol dependence during COVID-19 Pandemic | Lived Experiences of Wives of persons with Alcohol Dependence Syndrome during COVID-19 Pandemic | | Department of Psychiatry Government Medical College and Hospital Chandigarh | 29-01-2021 | 20210129 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46808 | Not Recruiting | No | | | | 15-02-2021 | 50 | Observational | Single Arm Trial
Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ajeet Sidana→ | | Department of Psychiatry,Room No. 530,Block D,level 5, Government Medical Collage and Hospital, sector 32 Chandigarh → | withkamlesh@gmail.com→ | 9038751120→ | Government Medical Collage and Hospital, sector 32, ChandigarhGMCH 32 Chandigarh→ | Inclusion criteria: Women whose husband has been diagnosed with alcohol dependence syndrome and taking treatment from GMCH. <br/ ><br> Age between 18-60 years. <br/ ><br> Can comprehend and speak well- Punjabi/ Hindi/English. <br/ ><br> Living with her husband in the same household for at least last six months. <br/ ><br> Who will give consent to participate in the study <br/ ><br>→ | Exclusion criteria: Wife should not be dependent on any substance (except nicotine and caffeine)→ | | Intervention1: NIL: NIL<br>→ | Types of domestic violence,psychological distress and coping style of wivesTimepoint: 6 Months→ | | | | Yes | False | | |
| → | CTRI/2021/02/030887 | 23 February 2021 | A safety and efficacy study of Eflornithine (NSRT2020â?¢) against the standard of care in adult hospitalized patients showing signs and symptoms of moderate COVID-19 infection. | A Phase II, open label, randomized, two arm, parallel group, multi-center, comparative clinical trial to evaluate the safety and efficacy of oral Eflornithine (NSRT2020â?¢) against the standard of care in adult hospitalized patients showing signs and symptoms of moderate COVID-19 infection. - BREATHEAZYâ?¢ Trial 1.1 | | Navin Saxena Research and Technology NSRTPvt Ltd | 01-02-2021 | 20210201 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48386 | Recruiting | No | | | | 10-02-2021 | 208 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2 | India→ | Divya C→ | | #2/5, 3rd Floor Dahlia Building, 80ft Road, RMV 2nd Stage, → | pm@bioagiletherapeutics.com→ | 08043754520→ | Bioagile Therapeutics Pvt. Ltd.→ | Inclusion criteria: 1. Is a Confirmed Case of Moderate COVID-19 infection. <br/ ><br> <br/ ><br>2.The patient must exhibit the following criteria: <br/ ><br> a)SpO2: <94% (range 90-94%) on room air. <br/ ><br> b)Respiratory Rate: â?¥ 24/ minute (range â?¥ 24 - 30); <br/ ><br> <br/ ><br>3.The patient may show any one or more of the below clinical symptoms: <br/ ><br> a)Fever <br/ ><br> b)Cough <br/ ><br> c)Dyspnoea and/or hypoxia <br/ ><br> <br/ ><br>4.Male or non-pregnant female adult requiring hospitalization, with or without comorbidities between the age group of 18-65 years of age at time of screening. <br/ ><br> <br/ ><br>5.Women of childbearing potential must agree to either abstain or use at least one primary form of contraception not including hormonal contraception from the time of screening to the end of study (Day 28 or live hospital discharge, whichever is earlier). <br/ ><br> <br/ ><br>6.Agrees not to participate in another clinical trial for the treatment of COVID-19 until the end of study (Day 28 or live hospital discharge, whichever is earlier). <br/ ><br> <br/ ><br>7.Subject (or legally authorized representative) provides written informed consent prior to initiation of any study procedures. <br/ ><br> <br/ ><br>8.Patients ability in the investigators opinion to comply with the protocol procedures. <br/ ><br>→ | Exclusion criteria: 1.Is a Confirmed Case of Mild COVID-19 infection (defined as per ICMR guidelines) without evidence of breathlessness or Hypoxia (normal saturation). <br/ ><br>2.Is a Confirmed Case of Severe COVID-19 infection (defined as per ICMR guidelines) exhibiting the following signs & symptoms: <br/ ><br> a)SpO2: <90% (on room air). <br/ ><br> b)Respiratory Rate: > 30/ minute; <br/ ><br> c)Chest imaging shows (Chest X ray and portable bed side lung ultrasound): <br/ ><br> bilateral opacities, not fully explained by effusions, lobar or lung <br/ ><br> collapse, or nodules. <br/ ><br>3.Testing positive for HIV, HbsAg and HCV infection. <br/ ><br>4.Females who are currently pregnant or breastfeeding. <br/ ><br>5.Has a known allergy or other contraindication to Eflornithine. <br/ ><br>6.Has received Eflornithine within the last 10 days. <br/ ><br>7.Has received anti-viral or anti-malarial or anti-bacterial within the last 14 days. <br/ ><br>8.Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN). <br/ ><br>9.QTc interval â?¥ 500ms. <br/ ><br>10.Recent Myocardial Infarction (within last 6 months). <br/ ><br>11.Known case of (K/C/O) Congestive heart failure. <br/ ><br>12.K/C/O Chronic Kidney Disease. <br/ ><br>13.K/C/O of epilepsy. <br/ ><br>14.K/C/O active Tuberculosis. <br/ ><br>15.In the opinion of the clinical team, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ ><br>16.The patient has participated in other clinical trials in the last three months. <br/ ><br>17.Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Eflornithine and SoC: Eflornithine Granules (2.5 g/dose) (Orange Flavour; Sugar Free) (NSRT2020â?¢) for oral solution administered every 6 hours (10.0 g/day) plus Standard of Care for 14days<br>Intervention2: Treatment Arm-2: Eflornithine (NSRT2020â?¢) for oral solution administered every 6 hours (20.0 g/day) + SoC excluding antimalarials, antivirals and corticosteroids.<br>Control Intervention1: Standard of care: Standard of Care for 14days<br>→ | Ordinal Scale Improvement (OSI): To evaluate the number and percentage of patients in the treatment arms showing an improvement of at least two or more points on a seven-point ordinal scale.Timepoint: Day 1 to Day 14→ | | | | Yes | False | | |
| → | CTRI/2021/02/030892 | 23 February 2021 | A clinical study to understand the effect of Inosine Pranobex in Covid-19 patients when used along with the defined standard of Care in Covid patients | A Phase 3, Double-Blind, Placebo-Controlled, Prospective, Randomized, Comparative, Parallel Group, Multi-Centre, Study to Assess the Efficacy and Safety of Inosine Pranobex Added to a Defined Standard of Care in Covid-19 Patients. | | Themis Medicare Ltd | 01-02-2021 | 20210201 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49972 | Recruiting | No | | | | 01-02-2021 | 416 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Mr Sangameshwar Iyer→ | | Floor 11/12, Udyog Nagar,S. V. Road, Goregaon (W), Mumbai → | ashok.swain@themismedicare.com→ | 9160255553→ | Themis Medicare Ltd→ | Inclusion criteria: 1. Written signed and dated informed consent (patient or LAR). <br/ ><br>2. Either gender, in the age group between 18 to 75 years <br/ ><br>3. Patients of laboratory confirmed COVID-19 [nasopharyngeal (preferred) or oropharyngeal swab RT-PCR positive] presenting with WHO listed symptoms of COVID-19 c/o fever, headache, myalgia, cough, throat pain or shortness of breath <br/ ><br>4. A score of between 3 to 5 on the Modified WHO Ordinal Scale for Clinical Improvement (refer protocol appendix 23.1) <br/ ><br>5. SpO2 â?¥90% for adults and respiratory rate â?¤ 30/minute <br/ ><br>6. Patients who provide a agree to abide by the study requirements <br/ ><br>→ | Exclusion criteria: 1. Known hypersensitivity to any of the ingredients of the study drug <br/ ><br>2. Pregnant and lactating women <br/ ><br>3. Children <18 yrs. of age; elderly >75 years <br/ ><br>4. SpO2 <90% for adults and respiratory rate >30/minute <br/ ><br>5. Known history of gout or hyperuricemia (serum uric acid level >6 mg/dl), urolithiasis, nephrolithiasis or any degree of renal dysfunction <br/ ><br>6. Patients with history of diagnosed primary congenital immunodeficiency, or acquired immunodeficiency like HIV, OR any Genetic or developmental anomaly like Cerebral Palsy, coeliac disease, lactose intolerant, cancer in nor remission stage. <br/ ><br>7. Patient who are undergoing treatment with xanthine oxidase inhibitors, uricosuric agents, diuretics, immunosuppressive agents or zidovudine. <br/ ><br>8. Patients with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases. <br/ ><br>9. Patients simultaneously participating in another clinical study. <br/ ><br>10. Medical or psychological conditions deemed by the investigators to interfere with successful participation in the study <br/ ><br>11. A subject who is judged by the investigator as inappropriate to participate in the study for any reason other than those mentioned above.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tab. Inosine Pranobex 500 mg: 50mg/kg/day (max 4 gm/day), 4 times in a day, Oral Administration for 10 days.<br>Control Intervention1: Placebo: 50mg/kg/day (max 4 gm/day), 4 times in a day, Oral Administration for 10 days.<br>→ | Percentage of patients with 2 points improvement or becoming asymptomatic (Grade 2 or less) on the modified ordinal scale for clinical improvement at Day 11 for two treatment armsTimepoint: Clinical Response on Day 11→ | | | | Yes | False | | |
| → | CTRI/2021/02/030878 | 23 February 2021 | A pilot study to assess the various dermatoses associated with usage of facial mask in COVID-19 Pandemic | A pilot study to assess the various dermatoses associated with usage of facial mask in COVID-19 Pandemic | | Nishi Nagaria | 01-02-2021 | 20210201 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51853 | Not Recruiting | No | | | | 01-02-2021 | 364 | Observational | Other
Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label→Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label | N/A | India→ | Nishi Nagaria→ | | Room no. 26, Department of Dermatology, Sri Devaraj Urs Medical College, RL Jalappa Hospital, Tamaka → | nishinagaria@yahoo.com→ | 08390883986→ | Sri Devaraj Urs AcademyofHigherEducation→ | Inclusion criteria: patients of either gender wearing masks→ | Exclusion criteria: people less than 1 month, unspecified gender, people not consenting to participate in the study→ | | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | The coronavirus disease pandemic has forged exponential use of masks of various kinds, not just by health workers but also by general population as a PPE <br/ ><br>Although contact dermatitis due to PPE is well reported, mask induced dermatitis is a relatively unexplored phenomenon. Which is why this study was conducted, to report a preliminary data of individuals experiencing various facial dermatoses due to face masks.Timepoint: The results will be assessed after 1 month of the study.→ | | 30/11/2020 | | Yes | False | | |
| → | CTRI/2021/02/030880 | 23 February 2021 | A Study to explore the challenges and adaptations in government schools in Tezpur in the context of the COVID-19 pandemic | Exploring the challenges and adaptations in the government schools in Tezpur in the context of COVID-19 pandemic | | Barsha Boruah | 01-02-2021 | 20210201 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45246 | Not Recruiting | No | | | | 05-02-2021 | 10 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Barsha Boruah→ | | Department of Clinical Psychology, Tezpur, Assam → | priyasaxena175@gmail.com→ | 9101473412→ | Lokopriya Gopinath Bordoloi Institute of Mental Health→ | Inclusion criteria: For Headmaster/ Principal <br/ ><br>1.Headmasters who have minimum 5 years of work experience in the post being held <br/ ><br>2.Headmasters who have been working in that particular school for more than 1 year <br/ ><br>3.Both male and female Heads of Schools <br/ ><br>For Teachers <br/ ><br>1.Teachers with minimum 2 years of experience <br/ ><br>2.Both male and female teachers <br/ ><br>3.Teachers who have been class teacher of any class from 6th -12th standard. <br/ ><br> <br/ ><br> <br/ ><br>→ | Exclusion criteria: FOR HEADMASTER/ PRINCIPAL <br/ ><br>1.Headmasters who had handed over charge to their subordinate during the covid-19 pandemic, due to their health condition. <br/ ><br>FOR TEACHERS <br/ ><br>1.Teachers who were asked not to provide active service during Covid-19 pandemic, due to their health condition <br/ ><br>2.Teachers who were on leave in the past 6 months due to other reasons <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Capturing the experience of headmasters and teachers in adapting to the challenges in the context of Covid 19, will be helpful in informing future course of action to facilitate better teaching-learning as well as teacher-student relationship. This, in turn, would facilitate healthy adaptations by students as well.Timepoint: single→ | | | | Yes | False | | |
| → | CTRI/2021/02/030897 | 23 February 2021 | Covid yoga practice among health care professionals having stress anxiety and depression | A pilot project to evaluate efficacy of yoga intervention for stress, anxiety and depression among healthcare professionals working in a frontline COVID-19 tertiary care hospital of New Delhi - CYP-HCP-SAD | | Department of Science and Technology | 01-02-2021 | 20210201 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52184 | Not Recruiting | No | | | | 11-02-2021 | 50 | Interventional | Non-randomized, Active Controlled Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr R P Beniwal→ | | Room No. 5 Department of Psychiatry, Centre of Excellence in Mental Health, ABVIMS & Dr Ram Manohar Lohia Hospital, New Delhi. Baba Kharag Singh Marg New Delhi→ | drrpbeniwal@gmail.com→ | 09811841351→ | Atal Bihari Vajpayee Institute of Medical Sciences-Dr Ram Manohar Lohia Hospital→ | Inclusion criteria: 1. Ability to provide written informed consent <br/ ><br>2. Age between 21-60 years <br/ ><br>3. Both genders <br/ ><br>4. Healthcare Professionals (HP) {nursing officers, junior and senior doctors, paramedical personnel} <br/ ><br>→ | Exclusion criteria: 1. Major mental illness <br/ ><br>2. Those who are already on psychiatry treatment for stress, anxiety and depression <br/ ><br>3. Active suicidality <br/ ><br>4. Substance Dependence except social use of alcohol and nicotine <br/ ><br>5. Pregnancy <br/ ><br>6. Unwilling or inability to attend three weeks (at least 4 days a wk.) of yoga <br/ ><br>7. Who have already participated in any other yoga studies or yoga training within last six months and/or those who do yoga regularly. <br/ ><br>→ | Health Condition 1: F439- Reaction to severe stress, unspecified
Health Condition 2: F439- Reaction to severe stress, unspecified
→ | Intervention1: Yoga Intervention: Yoga Training (YT): Participants will be imparted YT for twenty-one days, daily for one hour using a manualized protocol (Bhatia et al. 2012). On basis of this manualized protocol we designed this YT module for proposed project which includes postures or Asanas (exercises) and Pranayam (Breathing protocols). The yoga training will start with yogic prayer then shatkarma kriya like kapalbhati and trataka. We practice yogic sukshma and sthula vyayama for warm up the body and for proper joint movements. The asanas comprise of different postures; standing (Kati chakrasan, urdhva hastottanasana, vrikshasana, Trikonasan); supine (Setubandhasana, Naukasana, Urthsarvangasna, Savasana); prone (Makarasan, Bhujangasan, Shalabhasan, Dhanurasan); and sitting postures (Pashimottanasan, Gomukhasan, Vakrasana, Simhasana). <br>We planned this protocol for our participants and plan to include all forms of asanas (balancing postures, forward and backward bending, meditative and relaxation postures) in our training protocol. After asanas we will practice mudra and bandha followed by pranayam-ujjayi and bhramari. At the end of the session we will train our participants to practice dhyana (meditation). Our yoga protocol designed to include asanas in all positions- sitting, supine and prone position to provide maximum relaxation to participants which is essential for relieving COVID-19 related anxiety. The session will conclude with shanti patha (for wellness of all beings). <br><br>Control Intervention1: Not Applicable: Not Applicable<br>→ | The project will advance ancient Indian therapies for decreasing stress and improving anxiety, depressive symptoms, quality of sleep. It would help to assess level of recent perceived stress, quality of sleep, level of anxiety and depression among healthcare professionals during covid-19 outbreak and to evaluate the effect of a protocolized yoga-meditation intervention in improving quality of sleep and treating stress, anxiety and depression among participants.Timepoint: One year→ | | | | Yes | False | | |
| → | CTRI/2021/02/030946 | 23 February 2021 | Correlation of Vitamin B12 with blood clotting in COVID-19 patients | A study of correlation between Vitamin B12 levels and D-dimer levels - in COVID-19 positive patients at our hospital | | GCS Medical College Hospital and Research Centre | 02-02-2021 | 20210202 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52174 | Not Recruiting | No | | | | 17-02-2021 | 100 | Observational | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Karmay H Shah→ | | OPD 28, GCS Medical College, Hospital and Research Centre, Opposite DRM Office, Naroda Road, Ahmedabad → | Rrpatel9@gmail.com→ | 07966048028→ | GCS Medical College, Hospital and Research Centre→ | Inclusion criteria: 1.All patients who are COVID-19 positive by either COVID-19 RTPCR test or COVID-19 rapid antigen test or HRCT chest suggestive of active COVID-19 infection (CORADS III AND ABOVE) <br/ ><br>2.All genders <br/ ><br>3.Age above 18 years <br/ ><br>4.Patients willing to give consent for this study <br/ ><br>→ | Exclusion criteria: 1.Patients who are COVID-19 negative <br/ ><br>2.Patients who have taken Vitamin B12 supplements <br/ ><br>3.Patients who might have raised D-Dimer due to other known causes; e.g. heart disease, prolonged bed rest, post surgical, etc <br/ ><br>4.Pregnant and lactating women <br/ ><br>5.Age <18 years <br/ ><br>6.Patients not willing to give consent for this study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: nil: nil<br>→ | 1.To measure baseline Vitamin B12 levels in COVID19 positive patients <br/ ><br>2.To measure baseline D Dimer levels in these patients <br/ ><br>3.To measure maximum D Dimer levels in these patients through the course of hospital stay <br/ ><br>4.To analyse following in the study population: <br/ ><br> <br/ ><br>Duration of hospital stay <br/ ><br>Need for oxygen support <br/ ><br>Need for anticoagulation <br/ ><br>Clinical outcome(recovered/expired) <br/ ><br>Timepoint: 2 months→ | | | | Yes | False | | |
| → | CTRI/2021/02/030947 | 23 February 2021 | CT chest as a diagnostic tool for COVID 19 | Accuracy of Computed Tomography (CT) Chest as a diagnostic tool for COVID-19 patients in emergency department | | Department of Emergency Medicine | 02-02-2021 | 20210202 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52200 | Not Recruiting | No | | | | 08-02-2021 | 365 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Zara Javed Shah→ | | Department of Emergency Medicine, Max Super Specialty Hospital, 108 - A, I.P.Extension, Patparganj → | zarajshah@gmail.com→ | 8491849593→ | Max Super Specialty Hospital→ | Inclusion criteria: Patients > 18years of age. <br/ ><br> <br/ ><br>All the patients with SARI/ILI symptoms who have undergone chest CT and RT-PCR. <br/ ><br> <br/ ><br>Severe Acute Respiratory Infections (SARI):An acute respiratory infection with a history of fever or measured fever of > 38 degree Celsius and cough with onset within the last 7 days and requires overnight hospitalization. <br/ ><br> <br/ ><br>Influenza like Illness(ILI):Acute onset within the last ten days following respiratory symptoms,measured fever of 38 degree Celsius and cough. <br/ ><br>→ | Exclusion criteria: None→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: Nil: Nil<br>→ | RT-PCR positivity <br/ ><br>Timepoint: Baseline <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/02/030957 | 23 February 2021 | A clinical study to determine whether an alkaline barrier created in the oropharynx by use of spray containing 8.4% sodium bicarbonate can mitigate development of Influenza Like Illness (ILI) and Covid-19 infection. | A prospective, double arm, placebo control, single blinded, investigator led research to study the barrier strength of the aerosol against the development of Influenza Like Illness (ILI) including Covid-19 infection in the general as well as high risk population and to assess the safety and tolerability of an aerosol having as its active ingredient 8.4% sodium bicarbonate when administered to the oropharynx. | | Myself Health Check Ltd | 03-02-2021 | 20210203 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52251 | Not Recruiting | No | | | | 15-02-2021 | 325 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded | N/A | India→ | Kshitij Mody→ | | Orthopaedics Department,
Welcare Hospital
Near Mercedes Show Room, Atladara-Vadsar ring road, Atladara, Vadodara → | drkshitijmody@welcarehospital.co.in→ | | Welcare Hospital→ | Inclusion criteria: Subjects who meet all of the following criteria will be included in the study: <br/ ><br> <br/ ><br>1) Age: Adult 18 years inclusive and above at the time of consent. <br/ ><br>2) Sex: Adult, healthy males and non-pregnant/non-lactating females. <br/ ><br>3) Subjects are in good general health as determined by the Investigator on the basis of medical history reported by subjects including absence of symptom or signs of Covid-19 infection or any other ILI. <br/ ><br>4) Subjects must be able to understand and provide written informed consent to participate in the study. <br/ ><br>5) Subjects with no relevant findings in medical history or on physical examination which would suggest to the P.I. that the subject is unsuitable for inclusion in the study. <br/ ><br>6) Subjects who are willing to allow the Investigator to register volunteer details with a confidential database (The - Over-Volunteering Protection Service) to prevent concurrent entry into clinical studies/trials. <br/ ><br>7) Subjects who are able and willing to comply with all the trial requirements.→ | Exclusion criteria: Subjects who meet any of the following criteria will be excluded from the study: <br/ ><br> <br/ ><br>1) Subjects who have a clinically significant active Oral Cavity disease. <br/ ><br>2) Subjects who have a history of recent Oral ongoing treatment. <br/ ><br>3) Subjects who have a condition or are taking medication(s) which, in the judgment of the Investigator or Designate, makes the subject ineligible or places the subject at undue risk. <br/ ><br>4) Subjects who have received treatment (chemotherapy, radiation, immune suppressant medications) for any type of cancer within the last 6 months. <br/ ><br>5) Subjects who are currently participating in any another study related to Oral applications. <br/ ><br>6) Subjects who are currently participating in any clinical study, which in the judgment of the Investigator, could potentially affect responses in either study or have participated in a clinical study in the recent past up to three months. <br/ ><br>7) Subjects who have a known sensitivity or allergy relating to the substance(s) being evaluated. <br/ ><br>8) Subjects who are Pregnant, lactating or have the intention to become pregnant during trial period as determined by questioning the subject. <br/ ><br>9) Subjects with any pharyngeal, or laryngeal finding which precludes bronchoscopy.→ | | Intervention1: 8.4% Sodium Bicarbonate Oral Spray: ORAL SPRAY (Test A)<br>Sr. No. Material Name Label Claim Suggested Limit<br>01 Sodium Bicarbonate 8.4% 4.2 â?? 8.4<br>02 Glycerine 8.0% 4.0 â?? 12.0<br>03 Propylene glycol 5.0% 3.0 â?? 8.0 <br>04 Xylitol 5.0% 3.0 â?? 8.0<br>05 Benzalkonium chloride 0.01% 0.01 â?? 0.04<br>06 Polo Mint Flavour 0.01% 0.01 â?? 0.04<br>07 Neotam Sweetener QS <br>08 Brilliant Blue QS <br>09 Water<br><br><br>ORAL SPRAY (Placebo B)<br>Sr. No. Material Name Label Claim Suggested Limit<br>01 Glycerine 8.0% 4.0 â?? 12.0<br>02 Propylene glycol 5.0% 3.0 â?? 8.0 <br>03 Xylitol 5.0% 3.0 â?? 8.0<br>04 Benzalkonium chloride 0.01% 0.01 â?? 0.04<br>05 Polo Mint Flavour 0.01% 0.01 â?? 0.04<br>06 Neotam Sweetener QS<br>07 Brilliant Blue QS<br>08 Water<br>Test A will be an active ingredient and Placebo B will be a placebo.<br>Control Intervention1: N/A: N/A<br>→ | The proportion of subjects not getting ILI symptoms at the end of the study using the Flu-Pro Plus Patient Reported Outcome Measure (PROM).Timepoint: 28 days→ | | | | Yes | False | | |
| → | CTRI/2021/02/030950 | 23 February 2021 | A new test to diagnose COVID-19 | Validation of the TataMD CHECK CRISPR SARS-CoV-2 test 1.0 for the diagnosis of COVID-19 | | Tata Medical and Diagnostics Limited | 03-02-2021 | 20210203 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52209 | Not Recruiting | No | | | | 08-02-2021 | 150 | Observational | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Omshree Shetty→ | | Department of Molecular Pathology
Tata Memorial Hospital
Room Number 723
7th Floor
Annexe Building
Tata Memorial Hospital
Ernest Borges Road
Parel, Mumbai
→ | omshreens@gmail.com→ | 91-22-24177000→ | Tata Memorial Hospital→ | Inclusion criteria: RNA extracted from stored viral transport media (VTM) containing nasopharyngeal and/or oropharyngeal swabs submitted for testing for SARS CoV-2→ | Exclusion criteria: Nil→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | Sensitivity of TataMD CHECK CRISPR SARS-CoV-2 test 1.0 compared to real time RT-PCRTimepoint: 0 hours→ | | | | Yes | False | | |
| → | CTRI/2021/02/030986 | 23 February 2021 | A trial of sodium-copper-chlorophyllin given along with treatment of physicianâ??s choice versus treatment of physicianâ??s choice in asymptomatic or mildly symptomatic patients with Covid-19 | A phase-II, multi-centre, randomized, open label, two arm, controlled trial of sodium-copper-chlorophyllin given along with treatment of physicianâ??s choice versus treatment of physicianâ??s choice in asymptomatic or mildly symptomatic patients with SARS-CoV-2 Infection (Covid-19). | | IDRS Labs Private Limited | 04-02-2021 | 20210204 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51800 | Not Recruiting | No | | | | 05-02-2021 | 60 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Dr Ravi Alamchandani→ | | Veeda Clinical Research Pvt. Ltd Shivalik Plaza, Near I.I.M.
Ambawadi Ahmedabad, Gujarat 380 015 India Ahmadabad
GUJARAT 380015 India
Ahmadabad
GUJARAT
380015
India → | Ravi.A1950@veedacr.com→ | 7930013000→ | Veeda Clinical Research Pvt, Ltd.→ | Inclusion criteria: Male and non-pregnant female patients more than or equal to 18 years of age will be eligible if they meet all of the following criteria: <br/ ><br>1. Have positive reverse-transcriptase-polymerase chain reaction (RT-PCR) test for COVID-19 in a diagnostic specimen. <br/ ><br>2. Are either asymptomatic or have only mild symptoms (cough and/or fever and/or sore throat and/or other upper respiratory symptoms and/or malaise, headache, muscle pain) at the time of study inclusion. <br/ ><br>3. Have absolute lymphocyte count (ALC) less than 1000 cells/mm3, at the time of screening. <br/ ><br>4. Have an oxygen saturation of >94% while breathing ambient air. <br/ ><br>5. Have either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. High blood sugar or HbA1c of any degree will not be a criterion for exclusion. <br/ ><br>6. Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy [including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner] during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician.→ | Exclusion criteria: Patients will not be eligible for this study if any of the following in present at the time of study inclusion: <br/ ><br>1. Have pneumonia confirmed by chest imaging. <br/ ><br>2. Patients receiving mechanical ventilation or ECMO or who have multiorgan failure. <br/ ><br>3. Pregnant or lactating females. <br/ ><br>4. Therapy with an investigational agent within the past 30 days from screening. <br/ ><br>5. Treatment with any drug having anti-SARS-CoV-2 activity prior to screening including hydroxychloroquine and other antiviral agents. <br/ ><br>6. Any other conditions, including moderate to severe illness, which would make the patient, in the opinion of the Investigator, unsuitable for the study. <br/ ><br>→ | Health Condition 1: J00-J06- Acute upper respiratory infections
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: sodium-copper-chlorophyllin: Tablet sodium-copper-chlorophyllin(750 mg) one tablet will be administered orally for 10 days<br>Control Intervention1: Treatment of physicianâ??s choice: Physicians choice treatment<br>→ | 1. Proportion of patients who either continue to be COVID positive by RT-PCR at Day 5. <br/ ><br>OR <br/ ><br>2. Suffer clinical deterioration by Day 10 from the date of randomization (excluding the date of randomization) in test arm as compared to control arm. <br/ ><br>Timepoint: RT-PCR will be performed on day 5 after the 5th dose and the RT-PCR negative patients will be discharged on Day 6→ | | | | Yes | False | | |
| → | CTRI/2021/02/031011 | 23 February 2021 | Post Covid 19 disability scale translation to Kannada language | Covid â?? 19 Functional Status Scale (PCFS): Translation, Adaptation and Validation to Kannada Language | | Department of Psychiatry | 04-02-2021 | 20210204 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52142 | Not Recruiting | No | | | | 10-02-2021 | 80 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ravindra Munoli→ | | Department of Psychiatry
Kasturba Medical College, Manipal
Tq/Dt-Udupi → | ravindra.nm@hotmail.com→ | | Kasturba Medical College, Manipal→ | Inclusion criteria: -Patients above the age of 18 years who were diagnosed with Covid 19 and had come for evaluation/follow up <br/ ><br>-Consenting patients who are able to read and write Kannada <br/ ><br>→ | Exclusion criteria: Non consenting patients→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | Translation and Validity of Kannada version of Post Covid 19 functional Status Scale.Timepoint: It is a cross sectional study. Patients will rate their status retrospectively for 4th, 8th, 12th week etc in addition to current status.→ | | | | Yes | False | | |
| → | CTRI/2021/02/031012 | 23 February 2021 | Cotrimoxazole in hospitalised patients with severe COVID-19 infection | Cotrimoxazole in hospitalised patients with severe COVID-19 infection compared to the standard of care â?? an investigator-initiated, randomised controlled trial (CoTroxCov Study) | | Dept of Health and Family Welfare Government of West Bengal | 04-02-2021 | 20210204 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51954 | Recruiting | Yes | | | | 15-02-2021 | 200 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Bibhuti Saha→ | | Room No 20
Department of Tropical Medicine
School of Tropical Medicine
108, C R Avenue → | bibhuti.saha@gmail.com→ | 9831296071→ | School of Tropical Medicine→ | Inclusion criteria: a. Adult individuals, age >18 and <65 years <br/ ><br>b. COVID-19 infection documented by a positive RT-PCR test <br/ ><br>c. Hospitalised patients with severe COVID-19 infection, characterized by <br/ ><br>fever (at the time of screening or when admitted) and requiring supplemental oxygen through non- re-breath mask between 10L-15L/ min. <br/ ><br>d. Clinical/radiological evidence of interstitial pneumonia requiring admission (optional) <br/ ><br>e. Informed verbal consent under urgent conditions, documented in the electronically <br/ ><br>→ | Exclusion criteria: a. Patients who require invasive or non-invasive (including CPAP and high flow nasal cannula) ventilation at the time of inclusion. <br/ ><br>b. AST/ALT values >5 fold the ULN. <br/ ><br>c. Documented impairment of renal function <br/ ><br>d. Absolute neutrophil count below 500 cells/mm3 <br/ ><br>e. Absolute platelet count below 50,000 cells/mm3 <br/ ><br>f. Documented sepsis or high suspicion of superimposed severe bacterial or fungal infection <br/ ><br>g. Comorbidities or concomitant medications likely to be incompatible for cotrimoxazole use <br/ ><br>h. Pregnancy or lactation. <br/ ><br>i. History of cotrimoxazole hypersensitivity <br/ ><br>j. Patients participating in another clinical trial for SARS-CoV-2 infection <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Add-on oral cotrimoxazole: oral cotrimoxazole 960 mg three times daily for 7 days along with standard of care<br>Control Intervention1: Standard of Care: Standard of Care<br>→ | Mean change in clinical status assessment using the 7-point ordinal scale at day 7 after randomisation compared to baseline (Score ranges 1-7)Timepoint: Baseline <br/ ><br>Day 7→ | | | | Yes | True | parent | |
| → | CTRI/2021/02/031036 | 23 February 2021 | Effect of Gayatri Mantra and Pranayama on covid-19 patients. | A pilot study to see effect of gayatri mantra and pranayama in terms of inflammatory markers in hospitalized covid-19 patients. | | Department of Science Technology DST | 05-02-2021 | 20210205 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51219 | Not Recruiting | No | | | | 10-02-2021 | 20 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | N/A | India→ | DrRuchi Dua→ | | Level-6,Dept-Pulmonary Medicine, AIIMS RISHIKESH AIIMS RISHIKESH→ | ruchi.pulm@aiimsrishikesh.edu.in→ | 7895973469→ | AIIMS RISHIKESH→ | Inclusion criteria: Consenting <br/ ><br>18-70 years, either sex <br/ ><br>Diagnosed case of Covid-19 based on RT PCR, hospitalized at AIIMS Rishikesh covid centre in moderate symptom category as per ICMR guidelines (dyspnea/hypoxia with saturation <94% on room air/Respiratory rate >24breaths/minute)8 <br/ ><br>Having a smartphone and internet facility and able to use it <br/ ><br>Serum procalcitonin <0.5 ng/ml→ | Exclusion criteria: Non-consenting/critical category as per <br/ ><br>ICMR guidelines1 <br/ ><br> <br/ ><br>Patients in ICU or on mechanical <br/ ><br>ventilation/continuous NIV or Fio2 >.40 <br/ ><br> <br/ ><br>Patients unable to perform Pranakarshan <br/ ><br>Pranayama/Gayatri Mantra <br/ ><br> <br/ ><br>Patients with known psychiatric or <br/ ><br>COPD/CLD/CRF/BA/diabetics(HbA1c >7),se <br/ ><br>vere HT, malignancy,IBD,CAD. <br/ ><br> <br/ ><br>Pregnant/lactating females→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | Intervention1: Gayatri Mantra chanting and pranayama along with usual treatment: Intervention will be given by a certified Yoga instructor and usual treatment by qualified doctors <br>Gayatri mantra chanting and pranayama instruction will be given by video-conferencing /Google meet.<br>Patients will perform Regular 1-hour gayatri mantra chant and pranayama in the morning and in the evening in the hospitalized room or at home after discharge up to 14 days. <br>Intervention Video and pictures based on how to do Gayatri mantra and pranayama will be shared with covid-19 patients.<br>We will check haematological investigations/CXR at baseline and time of discharge/14th day<br>Questionnaires for Quality of Life (SGRQ)8, Depression/Anxiety (PHQ-99 & GAD-7)10 & Fatigue Scale will be administered at baseline and at 14th day telephonically.<br>Time for symptom abatement /cure by RT PCR will be recorded along with final outcomes & Total Duration of hospital stay by a questionnaire along with demographic data.<br>Google diary/ google meet to check adherence in intervention arm will be used.<br>Control Intervention1: usual treatment: ï?©Control group will be given usual treatment by qualified doctors for 14 days.<br>ï?©We will check haematological investigations/CXR at baseline and time of discharge/14th day<br>ï?©QLF, depression/anxiety & Fatigue Scale will be administered at 14th day telephonically<br>ï?©Time for symptom abatement /cure by RT PCR will be recorded along with final outcomes & Total Duration of hospital stay by a questionnaire along with demographic data.<br>→ | hs C-Reactive protein (highly sensitive CRP)Timepoint: baseline,at time of discharge/14 days→ | | | | Yes | False | | |
| → | CTRI/2021/02/031052 | 23 February 2021 | comparison of ease and duration of intubation with Macintosh versus King vision video-laryngoscope using COVID-19 barrier box on manikins, so that we can use one of them (according to study outcome showing ease of intubation) for intubation of COVID patients | Comparison of endotracheal intubation with Macintosh versus King vision video-laryngoscope using COVID-19 barrier box on manikins: A randomised crossover study | | NIL | 05-02-2021 | 20210205 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46372 | Not Recruiting | No | | | | 20-02-2021 | 32 | Interventional | Randomized, Crossover Trial
Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:→Randomized, Crossover Trial<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Satyabrata Guru→ | | Department of Trauma and Emergency, AIIMS Bhubaneswar, Odisha Same as address 1→ | satyabrataguru25@gmail.com→ | 9438641011→ | AIIMS, Bhubaneswar→ | Inclusion criteria: Faculty members and residents of Anaesthesia and Emergency medicine having intubation experience more than 1 year→ | Exclusion criteria: Faculty members and residents of Anaesthesia and Emergency medicine having intubation experience more than 1 year not willing to take part in the study→ | | Intervention1: COVID Barrier box: We intend to see ease and duration of intubation in Macintosh vs KVVL laryngoscope by using COVID barrier box on Manikin<br>→ | Time required for successful intubation (IT) in seconds measured by an observerTimepoint: The outcome ( IT) in seconds will be assessed from base line i.e. 0 seconds to time required for successful intubation→ | | | | Yes | False | | |
| → | CTRI/2021/02/031096 | 23 February 2021 | Role of CD4 cell counts in predicting disease outcome in covid positive patients | CD4 cell counts as a prognostic bio marker in Covid 19 infection in hospitalised patients - CD4 counts in Covid 19 | | Government Medical College | 08-02-2021 | 20210208 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51462 | Not Recruiting | No | | | | 08-02-2021 | 116 | Observational | Non-randomized, Multiple Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Gita Nataraj→ | | 7th floor MSB, KEM Hospital
Acharya Donde Marg Parel Mumbai → | gitanataraj@gmail.com→ | 9820067349→ | Seth G S Medical College and KEM Hospital→ | Inclusion criteria: Patient diagnosed as covid 19 infected either by RTPCR or Rapid antigen test. <br/ ><br>Patients diagnosed as Covid 19 positive will be divided into Group A and Group B as per Revised Guidelines on Clinical Management of COVID â?? 19. Ministry of Health & Family Welfare Directorate General of Health Services (EMR Division) Government of India. (12) <br/ ><br>Group A â?? RT PCR or RAT positive <br/ ><br>Severe pneumonia, acute respiratory distress syndrome, sepsis and septic shock will be considered as severe Covid infection <br/ ><br>Group B - RT PCR or RAT positive <br/ ><br>Uncomplicated illness and mild pneumonia will be considered as non-severe (mild/moderate) Covid infection <br/ ><br>→ | Exclusion criteria: HIV infected patients <br/ ><br>Patients on immunosuppressive therapy or any disease or therapy known to affect the CD4 counts e.g. autoimmune disease, tuberculosis, patients on chronic steroids, etc <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To determine the proportion of severe and mild covid patients with low CD4 countsTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2021/02/031079 | 23 February 2021 | Survey of challenges faced by Ethics Committees while reviewing protocols during COVID-19 pandemic | An International Survey of Ethics Committees (ECs)/ Institutional Board Review (IRBs)- Challenges and Practices Arising During Public Health Emergencies (PHEs) | | The study is Internationally coordinated by Good Clinical Practice Alliance Europe GCPA | 08-02-2021 | 20210208 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52326 | Not Recruiting | No | | | | 01-03-2021 | 1500 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Chile;India;Iran (Islamic Republic of);Liberia;Malaysia;Nigeria;Turkey→ | Dr Roli Mathur→ | | II Floor of Nirmal Bhawan,
ICMR Complex,
Poojanhalli Road, Off NH- 7,
Kannamangala Post → | mathurr@ncdirindia.org→ | 91-80-22176301→ | ICMR Bioethics Unit, ICMR- National Centre for Disease Informatics and Research (NCDIR)→ | Inclusion criteria: Members of Ethics Committees registered with DHR→ | Exclusion criteria: Ethics Committee members not involved in reviewing protocols related to vaccine trials during public health emergencies. <br/ ><br> <br/ ><br>Those who do not give Informed Consent.→ | | Intervention1: Not Applicable: Not Applicable<br>→ | The expected outcome of the survey is to have identified the specific ethical values, issues, procedures and practices that ethics committees have encountered in their ethical review of COVID-19 research or other previous Public Health Emergency research particularly with respect to vaccine clinical trials.Timepoint: upto 31st May 2021→ | | | | Yes | False | | |
| → | CTRI/2021/02/031123 | 23 February 2021 | Antibodies to COVID vaccine | Antibody response to coronavirus disease 2019 (COVID-19) vaccine in healthcare workers of a multi-specialty hospital - ARC | | Kolkata Gastroenterologists association | 09-02-2021 | 20210209 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51974 | Not Recruiting | No | | | | 11-02-2021 | 1000 | Observational | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Shivaraj Afzalpurkar→ | | Day care building, fourth floor
Institute of Gastrosciences and Liver, Apollo Gleneagles Hospital
EM Bypass road
58 canal circular road
Kolkata-54 Day care building, fourth floor
Institute of Gastrosciences and Liver, Apollo Gleneagles Hospital
EM Bypass → | drshivaraj62@gmail.com→ | 07038578275→ | Apollo Gleneagles hospital→ | Inclusion criteria: All the healthcare workers who are getting vaccinated with COVID19 Vaccine (COVISHIELD)→ | Exclusion criteria: Pregnant and lactating mothers→ | | Intervention1: Antibody measurement: Measurement of antibody levels in those who are getting vaccinated with COVID vaccine at a dose of 0.5 ml, Intramuscular on deltoid<br>Intervention2: Not applicable: It is an observational study<br>Control Intervention1: NIL: NIL<br>→ | Geometrical mean antibody levels measured at day 0, day 30 and day 60 of COVID-19 vaccinationTimepoint: Day 0, 30, 60→ | | | | Yes | False | | |
| → | CTRI/2021/02/031115 | 23 February 2021 | Clinical profile and outcome in COVID-19 positive cases in rural population. | Clinical profile and outcome in COVID-19 confirmed positive cases in Odisha rural population. | | No | 09-02-2021 | 20210209 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52268 | Not Recruiting | No | | | | 12-02-2021 | 200 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rabinarayan Rout→ | | Department of Medicine, Kalinga Institute of Medical Sciences, KIIT university, Patia, Khorda district, Bhubaneswar, Odisha, 751024 → | rabinarayan.rout@kims.ac.in→ | 8908808915→ | Kalinga Institute of Medical Sciences→ | Inclusion criteria: All the COVID 19 confirmed positive patients presenting to Balangir covid hospital in the duration of 3 months will be considered as study subjects.→ | Exclusion criteria: No→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | By knowing the clinical characteristics and factors influencing the outcome of COVID-19 confirmed cases, we can better manage the outbreak of pandemic in resource-limited settings.Timepoint: At baseline, at 5 days, at 10 days and after 2 weeks.→ | | | | Yes | False | | |
| → | CTRI/2021/02/031139 | 23 February 2021 | Impact of COVID - 19 pandemic on the outpatient dental visits. | Changing trends in the outpatient dental visits during COVID â?? 19 pandemic | | Dr Medhini Madi | 09-02-2021 | 20210209 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49499 | Not Recruiting | No | | | | 01-03-2021 | 3821 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | N/A | India→ | Dr Mathangi Kumar→ | | Department of Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal Department of Oral Medicine and Radiology, Manipal College of Dental Sciences, Manipal→ | mathangi.kumar@manipal.edu→ | 9620299924→ | Manipal College of Dental Sciences, Manipal→ | Inclusion criteria: The data of the patients who reported to the Department of Oral Medicine and Radiology MCODS, Manipal from the time period 24/09/2019 to 24/09/2020 will be included in the study.→ | Exclusion criteria: Patients with incomplete data will be excluded from the study. <br/ ><br>Patients who have directly visited the emergency triage or trauma triage and have not subsequently visited the dental outpatient department will be excluded from the study. <br/ ><br>Patients referred from private clinics outside MCODS, Manipal for radiographic investigations will be excluded from the study. <br/ ><br>→ | Health Condition 1: K122- Cellulitis and abscess of mouth
→ | Intervention1: Not applicable: Not applicable<br>→ | This study will explore and highlight the striking changes in the trends of the outpatient dental visits during the pandemic. This study will also reveal the several possible causes that could have led to the changing trends in the visits of patients for dental treatment. The results of this study may give us an insight into the difficulties faced by the patients as well as the health professionals in an unprecedented pandemic situation.Timepoint: 12 months→ | | 17/12/2021 | | Yes | False | | |
| → | CTRI/2021/02/031138 | 23 February 2021 | Observational study of severity and outcomes of artificially respiring COVID-19 positive patients with COVID-19 Complication causing respiratory distress. | Severity and Outcomes of Mechanically Ventilated COVID-19 patients - A Retrospective Study | | Monica Patricia Lobo | 09-02-2021 | 20210209 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52439 | Not Recruiting | No | | | | 15-02-2021 | 50 | Observational | Other
Method of generating randomization sequence:Other Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India→ | Dr Glenn Austin Fernandez→ | | Assistant Professor, Department of General Medicine, Father Muller Medical College, Father Muller Road, Kankanady, Mangalore-575002 → | glennindia@fathermuller.in→ | 8884875845→ | Father Muller Medical College→ | Inclusion criteria: Patients tested positive for COVID-19 by RT-PCR <br/ ><br>Patients requiring mechanical ventilation in the COVID-19 ICU of a tertiary care medical college hospital for Acute Respiratory Distress Syndrome→ | Exclusion criteria: Patients tested Positive for COVID-19 by RT-PCR, requiring mechanical ventilation in the COVID-19 ICU of a tertiary care medical college hospital for reasons other than Acute Respiratory Distress Syndrome. <br/ ><br>Patients whose age is less than 18 years. <br/ ><br>Pregnant patients who are tested positive. <br/ ><br>→ | Health Condition 1: A00-B99- Certain infectious and parasitic diseases
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Severity and outcomes of mechanically ventilated patients will be measured by various parameters on a pre-designed proforma and assessed.Timepoint: It is a retrospective observational study, Hence there are no time points.→ | | | | Yes | False | | |
| → | CTRI/2021/02/031176 | 23 February 2021 | Effectiveness of Phase I Cardiac Rehabilitation among Patients Undergoing CABG Surgery - A Randomized Controlled Trial | Effectiveness of phase I cardiac Rehabilitation on postoperative outcome among patients undergoing coronary artery Bypass grafting surgery in a tertiary care center Thiruvananthapuram, RCT | | Remya JM | 10-02-2021 | 20210210 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52050 | Not Recruiting | No | | | | 14-02-2021 | 70 | Interventional | Other
Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded→Other<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded | N/A | India→ | Remya J M→ | | Nandanam
Market Junction
Vellanad
Thiruvananthapuram MSc II Year
Govt College of Nursing
Thiruvananthapuram→ | preethynair79@rediffmail.com→ | 8139005157→ | College of Nursing, Thiruvananthapuram→ | Inclusion criteria: 1. Patients admitted for routine coronary artery bypass grafting surgery for the first time at a tertiary care centre. <br/ ><br>2. Patients who are willing to participate in the study. <br/ ><br>3. Patients who are able to read and write Malayalam. <br/ ><br>→ | Exclusion criteria: 1. Patients having severe LV dysfunction. <br/ ><br>2. Coronary artery bypass grafting surgery on emergency basis. <br/ ><br>3. Patients having psychological disturbances who cannot able to follow instructions. <br/ ><br>→ | Health Condition 1: I00-I99- Diseases of the circulatory system
→ | Intervention1: Phase I Cardiac Rehabilitation: Formal permission for data collection will be obtained from institutional research committee, ethics committee, Medical College Hospital, Thiruvananthapuram and from head of the department of cardiothoracic and vascular surgery. The samples who met the inclusion criteria will be selected. Those who meet eligibility criteria and who are willing to participate in the study will be identified. Objectives of the study will be explained and informed consent will be taken by ensuring COVID 19 basic protocol. Those who consented for the study will be allocated. Those who are willing to participate allocated randomly to experimental and control group using block randomization with a fixed block size 4 .Allocation concealment will be done by using an opaque sealed envelope. Both the experimental and control group get routine hospital care which include pre-operative counselling regarding admission process, hospital stay and routine checkup (Dental, E.N.T and Anesthesia checkup)and post operatively they are trained for incentive spirometry exercises and post discharge advices are given about home care management. Patients in the experimental group will be given preoperative care along with routine care on stress management and exercises and counselling before surgery on the outpatient department 2 weeks prior to surgery. The counselling session includes preoperative, postoperative and post-discharge counselling. On the day of admission, they are again counselled with demonstration and return demonstration of preoperative and post-operative care and motivated on adherence to preoperative and postoperative care. After surgery patientsâ?? performance on the postoperative care instructed is reinforced and they are followed up to assess t→ | the investigator assume that there is change in cardiac function respiratory function <br/ ><br>wound infection, and anxiety level of CABG patients experimental group than in control group Timepoint: The primary outcome is assessed within 45 days. The assessment will be done preoperatively, postoperatively (3rd day), before discharge and first follow-up→ | | | | Yes | False | | |
| → | CTRI/2021/02/031197 | 23 February 2021 | Association of tuberculosis with Covid-19 infection in children | Association of COVID-19 infection with tuberculosis in children: retrospective case-control study | | Nil | 10-02-2021 | 20210210 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51049 | Not Recruiting | No | | | | 18-02-2021 | 40 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rahul Jain→ | | Department of Pediatrics
Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi → | drrahuljain1980@gmail.com→ | | Maulana Azad Medical College→ | Inclusion criteria: Patients admitted with laboratory confirmed diagnosis of COVID-19 infection in the Pediatrics department <br/ ><br>Patients with current diagnosis of tuberculosis or previous diagnosis in last 7 months, concomitantly with COVID-19. <br/ ><br>Patients admitted between 15th March 20 and 31st October 20→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Association between Pediatric COVID-19 and tuberculosisTimepoint: At discharge from Paediatric unit.→ | | | | Yes | False | | |
| → | CTRI/2021/02/031165 | 23 February 2021 | Level of IgG Antibodies against Covid19 in people of Ahmedabad as on February 2021 | Fourth Population Based Serosurveillance for SARS-COV2 using IgG Antibodies in Ahmedabad | | Ahmedabad Municipal Corporation | 10-02-2021 | 20210210 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52169 | Not Recruiting | No | | | | 11-02-2021 | 10000 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Om Prakash→ | | 2nd Floor, Office of Deputy Municipal Commissioner (Health)
Sardar Patel Bhavan, Danapith
Ahmedabad Mahanagar Seva Sadan, Sardar Patel Bhavan, Danapith, Ahmedabad→ | dromprakash2006@gmail.com→ | 9099012740→ | Ahmedabad Municipal Corporation→ | Inclusion criteria: Those who give written informed consent→ | Exclusion criteria: any bleeding disorder, contraindication to venipuncture & hospitalized patients→ | | | Seroprevalence of IgG Antibodies against SARS-CoV-2 in general population of AhmedabadTimepoint: 1 (since this is a cross sectional study (A serosurveillance using Covid-Kavach - IgG antibody for SARS-CoV2) there is only 1 time-point)→ | | | | Yes | False | | |
| → | CTRI/2021/02/031232 | 23 February 2021 | Perceived stress and potential correlates among the frontline nurses during the COVID -19 pandemic. | Psychological effects of COVID-19 pandemic among frontline nurses | | Nil | 11-02-2021 | 20210211 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52011 | Not Recruiting | No | | | | 02-03-2021 | 140 | Interventional | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Suba Sooria→ | | Department of Nursing Services
Ground floor, OPD Block
Kasturba Hospital, Madhavnagar Manipal - 576104 Same as above→ | suba.sooria@manipal.edu→ | 9745388223→ | Kasturba Hospital, MAHE, Manipal→ | Inclusion criteria: Frontline nurses working in COVID ICUâ??s of Kasturba Hospital, Manipal, Karnataka, who are <br/ ><br>willing to participate in the study and willing to undergo the targeted intervention <br/ ><br>programme <br/ ><br>→ | Exclusion criteria: Frontline nurses working in COVID ICUâ??s of Kasturba Hospital, Manipal, Karnataka, who <br/ ><br>are not willing to participate in the study <br/ ><br>â?¢ Frontline nurses who are not available during the time of study. <br/ ><br>→ | | Intervention1: Professional counselling: This study explores perceived stress level of frontline nurses, specifically examines the demographic variables that determine perceived stress and interventions to maintain their psychological well-being. Appropriate counselling and explanation will be provided if required.<br>Total duration of intervention is 4 weeks<br>Control Intervention1: Comparator agent Not applicable: Not applicable<br>→ | to assess the level of perceived stress level of fatigue and potential correlates among the frontline nurses during the COVID -19 pandemicTimepoint: The outcome will be assessed/estimated i.e. at baseline, 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/02/031212 | 23 February 2021 | Blood sugars and COVID | Newly detected hyperglycemia in patients admitted with COVID -19 : is there an association of glycemic status with C- peptide levels, risk factors for diabetes and clinical outcomes | | Father Muller Research centre | 11-02-2021 | 20210211 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48458 | Not Recruiting | No | | | | 28-02-2021 | 30 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Smitha Bhat→ | | Department of Medicine
Father Muller Medical College
Mangalore → | doctorsmithabhat@gmail.com→ | 09845162167→ | Father Muller Medical College→ | Inclusion criteria: Adult patients between the ages of 18 and 85, admitted with COVID. <br/ ><br>1. Mild COVID 19 admitted to hospital â?? RT-PCR or CB NAT positive â?? Respiratory rate < 24, Oxygen saturation on room air > 94% and blood sugar on admission > 180 mg% <br/ ><br>2. Moderate COVID 19 admitted to hospital â?? RT-PCR or CB NAT positive - Respiratory rate between 24 and 30 , Oxygen saturation on room air between 90 and 94% and blood sugar on admission > 180 mg% <br/ ><br>3. Severe COVID admitted to hospital â?? RT-PCR or CB NAT positive - Respiratory rate more than 30 , Oxygen saturation on room air less than 90% and blood sugar on admission > 140 mg% ( Stricter glycemic control cut off in patients who are critically ill) (12) <br/ ><br>→ | Exclusion criteria: 1. Subjects with IFG/IGT on treatment or known cases of diabetes <br/ ><br>2. HbA1C > 6.5 <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | Days of ICU stay <br/ ><br>DeathTimepoint: At admission <br/ ><br>3 days after admission <br/ ><br>1 week after admission <br/ ><br>2 weeks after admission <br/ ><br>At discharge→ | | | | Yes | False | | |
| → | CTRI/2021/02/031230 | 23 February 2021 | Estimation of vitamin D levels in covid 19 positive patients. | A correlational study between vitamin D levels in covid 19 positive patients in GCS hospital. | | Gcs medical hospital | 11-02-2021 | 20210211 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52097 | Not Recruiting | No | | | | 15-02-2021 | 100 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Shraddha Tewari→ | | Opd no 28, Respiratory medicine department,GCS hospital,opp DRM office ,near chamunda bridge, Ahmedabad. → | rrpatel9@gmail.com→ | 07966048028→ | Gcs Medical College and research centre→ | Inclusion criteria: Patients who are covid 19 positive either by covid19 rtpcr or rapid antigen or hrct positive. <br/ ><br>Patients who are willing to give consent. <br/ ><br>Above 18 years of age.→ | Exclusion criteria: Patients who are covid 19 negative. <br/ ><br>Patients not willing to give consent. <br/ ><br>Patients below 18 years of age. <br/ ><br>Pregnant and lactating women. <br/ ><br>Patients who have taken vitamin d supplements.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | Vitamin D levels affecting morbidity and mortality in covid 19 positive patientsTimepoint: 1 month→ | | | | Yes | False | | |
| → | CTRI/2021/02/031246 | 23 February 2021 | Assessing the effectiveness of Breathing Exercises in Sars-Cov-2 Positive patients enrolled under Home Isolation | Assessing the effectiveness of Breathing Exercises in Sars-CoV-2 Positive Patients Under Home Isolation | | NOT APPLICABLE | 12-02-2021 | 20210212 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52232 | Not Recruiting | No | | | | 15-02-2021 | 50 | Interventional | Other
Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | MANGALASELVI R→ | | Division of Respiratory Care, Department of Respiratory Medicine, OPD NO. 4, G-Block, Sri Ramachandra Hospital, Porur chennai - 116 College of Allied Health Sciences, Division of Respiratory Care, SRI HER, SRMC, Chennai→ | koushikmuthuraja.m@sriramachandra.edu.in→ | 9884965848→ | Sri Ramachandra University, SRI HER→ | Inclusion criteria: Patients with positive RT PCR Test (Reverse Transcriptase polymerase chain reaction -(PCR)) test <br/ ><br>Showing only mild symptom, not requiring hospital stay & enrolled under Home Isolation Care of SRI HER, SRMC→ | Exclusion criteria: 1. Age less than 18 years <br/ ><br> <br/ ><br>2. Covid positive Patients classified as moderate/severe cases requiring hospital admission with RR >30bpm Spo2 <92% HR >125bpm <br/ ><br>Severe dyspnea (minimal effort or rest) <br/ ><br>Signs of respiratory compromise (cyanosis, use of accessory muscles) <br/ ><br>Altered alertness (lethargy, acute confusion, disorientation) <br/ ><br> <br/ ><br>3. Patients not willing to participate in the study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B978- Other viral agents as the cause ofdiseases classified elsewhere
→ | Intervention1: Breathing exercises: The patients will be instructed to do the recommended breathing exercises for 15 minutes/time with each exercise lasting 5 minutes for 3 times a day for a period of 14-days<br>→ | Anxiety levels at baseline and at 14 daysTimepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2021/02/031256 | 23 February 2021 | Madhav Rasayan Plus in subjects of COVID 19. | Clinical validation of safety & efficacy of Madhav Rasayan Plus in subjects of COVID 19. - Nil | | Shree Vishwavati Ayurvedic Chikitsalaya and Research Centre | 12-02-2021 | 20210212 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52613 | Not Recruiting | No | | | | 19-02-2021 | 40 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Tushar Saundalgikar→ | | OPD 2, First Floor, Shree Vishwavati Ayurvedic Chikitsalay and Research Centre,
Mangalwar Peth, Kolhapur. → | prasadpandkar9@gmail.com→ | | Shree Vishwavati Ayurvedic Chikitsalay and Research Centre→ | Inclusion criteria: Age -18- 60 years (Both sex) <br/ ><br>Confirmed COVID 19 patient with positive RT-PCR <br/ ><br>Moderate to severe symptomatic patients having no signs of ARDS (NEWS score â?¤8) <br/ ><br>Subject willing to provide consent and follow up for study duration <br/ ><br>→ | Exclusion criteria: Patients with autoimmune disease or self-reports HIV or syphilis infection <br/ ><br>Proves to be unfit for the study as per the investigatorâ??s discretion <br/ ><br>Pregnant or lactating women <br/ ><br>Requiring ICU admission at screening <br/ ><br>Any other comorbidity which is critical stage at screening which in investigator discretion finds subject not suitable for the trial participation→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Madhav Rasayan Plus: Madhav Rasayan Plus capsule 250 mg BD orally along with standard of care for 15 days<br>Control Intervention1: Standard of care: Standard of care as per ICMR protocol for 15 days<br>→ | Improvement of clinical symptoms including cough, breathlessness, gastric disturbance, anosmia, fatigue and myalgia on 10 point VAS scale 0- no symptom and 10-severe symptom <br/ ><br>Reduction in elevated levels of inflammatory markers such as CRP, LDH and Ferritin <br/ ><br>Reduction in levels of tissue level markers like Creatinine Phosphokinase and NT-Pro BNPTimepoint: Baseline to end of study ie 15 days→ | | | | Yes | False | | |
| → | CTRI/2021/02/031295 | 23 February 2021 | Intranasal Adenoviral vector COVID-19 vaccine (BBV154) Phase 1 study | A Phase 1, Randomized, Double-blinded, Multicenter Study to Evaluate the Reactogenicity, Safety, and Immunogenicity of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers. - BBIL/BBV154/2020 | | Bharat Biotech International Ltd | 15-02-2021 | 20210215 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51327 | Not Recruiting | No | | | | 20-02-2021 | 175 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 1 | India→ | Dr Shashi Kanth Muni→ | | Medical Affairs, Bharat Biotech International Limited, Genome valley, Shameerpet,
Hyderabad, Telangana → | shashikanth4257@bharatbiotech.com→ | 914027784583→ | Bharat Biotech international Limited→ | Inclusion criteria: <br/ ><br>1. Ability to provide written informed consent. <br/ ><br>2. Participants of either gender of age between â?¥18 to â?¤60 years. <br/ ><br>3. Good general health as determined by the discretion of investigator (vital signs (heart rate â?¥60 toâ?¤100 bpm; blood pressure systolic â?¥90 mm Hg and <140 mm Hg; diastolic â?¥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination). <br/ ><br>4. Expressed interest and availability to fulfil the study requirements. <br/ ><br>5. For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination. <br/ ><br>6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination. <br/ ><br>7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination. <br/ ><br>8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination. <br/ ><br>9. Agrees not to participate in another clinical trial at any time during the study. <br/ ><br>10. Agrees to remain in the study area for the entire duration of the study. <br/ ><br>11. Willing to allow storage and future use of biological samples for future research. <br/ ><br>→ | Exclusion criteria: 1. History of any other COVID-19 investigational/or licensed vaccination. <br/ ><br>2. Unacceptable laboratory abnormality at screening (prior to first vaccination) or safety testing, as listed below <br/ ><br>3. [Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen] (Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary care provider for follow up of these abnormal laboratory tests). <br/ ><br>4. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA or CLIA method. <br/ ><br>5. Any history of facial nerve paralysis <br/ ><br>6. History of cold, sneezing, nasal obstruction in the past 3 days. <br/ ><br>7. Prescribed usage of any nasal spray/or nasal drop medication. <br/ ><br>8. Any significant abnormality altering the anatomy of the nose in a substantial way or nasopharynx that may interfere with the aims of the study and in particular any of the nasal assessments or viral challenge (historical nasal polyps can be included, but large nasal polyps causing current and significant symptoms and/or requiring regular treatments in the last month are excluded) <br/ ><br>9. For women of child bearing potential, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine). <br/ ><br>10. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ ><br>11. Medical problems as a result of alcohol or illicit drug use during the past 12 months. <br/ ><br>12. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrolment or expects to receive an investigational agent during the study period. <br/ ><br>13. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ ><br>14. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ ><br>15. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ ><br>16. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. <br/ ><br>17. Long-term use ( > 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed). <br/ ><br>18. Any history of hereditary angioedema or idiopathic angioedema. <br/ ><br>19. Any history of anaphylaxis in relation to vaccination. <br/ ><br>20. Any history of albumin-intolerance. <br/ ><br>21. Pregnancy, lactation, or willingness/intention to become pregnant during the study. <br/ ><br>22. History of any cancer. <br/ ><br>23. History of severe psychiatric severe conditions likely to affect participation in the study. <br/ ><br>24. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. <br/ ><br>25. Any other serio→ | | Intervention1: Adenoviral vector vaccine(BBV154): The vaccine(BBV154) is Administered intranasal, in single or two doses, on Day 0 and Day 28<br>Control Intervention1: Placebo: Administered intranasal, in single or two doses, on Day 0 and Day 28<br>→ | 1.To evaluate the reactogenicity and safety of BBV154 (Adenoviral vectored based SARS-CoV-2 virus) vaccine administered via the intranasal route. <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Baseline, Day 28 [Time Frame: within 2 hours post each vaccination] <br/ ><br>[Time Frame: 7 days]. <br/ ><br>The occurrence of serious adverse events (SAEs) [Time Frame: throughout the study duration]. <br/ ><br>The occurrence of any unsolicited adverse events up to day 35 from 1st dose vaccination. [Time Frame: up to day 35 from 1st dose vaccination].→ | | | | Yes | False | | |
| → | CTRI/2021/02/031286 | 23 February 2021 | Internet based self-guided intervention for COVID-19 related dysfunctional worry | A brief internet based self-guided intervention for dysfunctional worry related to COVID 19 in India: A randomized controlled trial
| | Department of Clinical Psychology National Institute of Mental health and NeurosciencesNIMHANS | 15-02-2021 | 20210215 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52451 | Not Recruiting | No | | | | 27-04-2021 | 290 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable | N/A | India→ | Paulomi M Sudhir→ | | Department of Clinical Psychology, NIMHANS, Hosur Road → | paulomi@nimhans.ac.in→ | 8026995184→ | Clinical Psychology, NIMHANS→ | Inclusion criteria: The following 2 criteria for worry must be met: <br/ ><br>Worrying about COVID-19 and its possible consequences (e.g. risk of getting ill, fear of death, economy, family, etc.) every day, often several times a day <br/ ><br>The worry about COVID-19 is perceived as difficult to control <br/ ><br> In addition, at least one of the following negative consequences of worrying: <br/ ><br>The worry about COVID-19 takes so much time and energy that it is difficult to concentrate on anything else (work, family, hobbies, etc.) <br/ ><br>Trouble sleeping due to COVID-19 worries <br/ ><br>Constantly checking the news and social media to follow developments about COVID-19 <br/ ><br>Marked loss of work productivity due to worries about COVID-19 <br/ ><br>Difficulties finding joy in everyday situations because of worry about COVID19 <br/ ><br>Aged 18 years and above <br/ ><br>Having access to a computer or a similar device (smart phone)- with regular internet access <br/ ><br>Ability to read, write and comprehend English <br/ ><br>→ | Exclusion criteria: Severe depression, defined as >28 points on the MADRS-S <br/ ><br> Suicidal risk defined as 5 points or above on item 9 on the MADRS-S <br/ ><br> <br/ ><br>→ | | Intervention1: Psychological intervention internet based: It is a brief self-guided internet based intervention- <br>The intervention has psychological components to manage worry and for problem solving<br>Control Intervention1: Wait list control: wait list control, with option of cross over after 3 weeks<br>→ | GAD-7 worry and anxiety scoreTimepoint: baseline, 1 week, 3 weeks and 52 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/02/031322 | 23 February 2021 | Study of Effectiveness of Telemedicine Based Pulmonary Rehabilitation in Recovered patients of Covid 19 Lung Infection | STUDY OF EFFECTIVENESS OF TELEMEDICINE BASED PULMONARY REHABILITATION IN RECOVERED PATIENTS OF COVID -19 PNEUMONITIS | | Vardhman Mahavir Medical College and Safdarjung Hospital | 16-02-2021 | 20210216 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52024 | Not Recruiting | No | | | | 16-03-2021 | 50 | Interventional | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr R K Wadhwa→ | | Room No-33 Ground floor,PMR department, OPD building, Safdarjung Hospital,New Delhi → | rkwadhwa79@gmail.com→ | 01126164887→ | VMMC AND SAFDARJUNG HOSPITAL→ | Inclusion criteria: a. COVID-19 recovered patients (age 18-80 years) with clinical and/ radiological evidence of pneumonitis with follow up within 15 days post discharge from hospital. <br/ ><br>b. Patient with basic smartphone and internet availability→ | Exclusion criteria: a. Pneumonitis due to other cause and clinical evidence of existing lung diseases like COPD, Interstitial lung disease <br/ ><br>b. Uncontrolled diabetes and hypertension <br/ ><br>c. Any major symptomatic illness like ischemic heart disease, chronic kidney disease <br/ ><br>d. Dementia/ Cognitive impairment or symptomatic psychiatric illness <br/ ><br>e. An impaired hearing and / or vision disability which means that the instructions are not understood→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: six weeks pulmonary rehabilitation exercise programme.: The initial assessment shall be done in the physical presence of the patient and the remaining 6-weeks pulmonary rehab program shall be advised and monitored through telemedicine (Video consultation/40-minute session) thrice in a week.<br>Depending upon assessment individualized PR program shall be prescribed. The patient shall be counselled about the effect of COVID-19 on the lungs and the importance of PR program. The video call-based PR monitoring and supervised program shall be conducted thrice a week for 6 weeks. Each session shall last for 45 to 60 minutes. Each session includes breathing exercises, incentive spirometry, cough removal techniques, stretching exercises; home-based aerobic conditioning exercise, and strengthening exercises of upper and lower limbs.<br>Intervention2: NOT APPLICABALE: NOT APPLICABALE<br>Control Intervention1: NOT APPLICABALE: NOT APPLICABALE<br>→ | 1.reduction of dyspnea according to Modified Medical Research Council Scale <br/ ><br>2. reduced morbidity (physical and mental function) according to 6MWT and 30 seconds sit-to-stand test <br/ ><br>3.improvement in the quality of life in recovered patients of COVID-19 Pneumonitis according to WHO Quality of life scaleTimepoint: 0 weeks and 6 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/02/031353 | 23 February 2021 | Ayurveda clinical trial on mildly symptomatic COVID- 19 patientsâ?? | A Prospective, Open Label, Three Arm, Controlled Study to Assess The Immune-Boosting Activity of Jeevaneeyam Tablets Plus Ojovardhini Capsule (Test Formulation A), Amrutha Sanjeevini Tablets plus Ojovardhini capsule (Test Formulation B) in mildly symptomatic COVID- 19 patients | | Sri Sharada Ayurveda Pharmacy and RD Centre | 17-02-2021 | 20210217 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52810 | Not Recruiting | No | | | | 24-02-2021 | 60 | Interventional | Non-randomized, Active Controlled Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | T N Gurupradad→ | | #13, Ground floor Room no 2 Department of administrative block Pampa Mahakavi Rd, Chikkanna Garden, Shankarapura, Bengaluru, Karnataka 560004 → | rptlprasad@gmail.com→ | 7847840073→ | Sri Sharada Ayurveda Pharmacy and R&D center→ | Inclusion criteria: 1.Subjects age group 18 - 70 years both gender <br/ ><br>2.Patients diagnosed with COVID-19 positive mild symptomatic patients (Confirmed by RTPCR) <br/ ><br>3.Patients with uncomplicated upper respiratory infection <br/ ><br>a. Spo2 >94% in room air <br/ ><br>b. Respiratory rate <24 per min <br/ ><br>c. No evidence of hypoxaemia or breathlessness <br/ ><br>4.Subjects willing to give a written informed consent and come for a regular follow up <br/ ><br>5.Subject willing to abide by and comply with the study protocol <br/ ><br>→ | Exclusion criteria: 1.Subjects below 18 and above 70 years of age <br/ ><br>2.Presence of acute hypoxic respiratory failure. <br/ ><br>3.Requiring Intensive care unit (ICU) stay. <br/ ><br>4.Patients who need mechanical ventilation. <br/ ><br>5.Category 6 or 5 based on modified 7-category ordinal scale of clinical status <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Jeevaneeyam Tablets Plus Ojovardhini Capsule <br>(Test Formulation A): Dosage form: Tablet and capsule <br>Frequency : 14 days Twice a day morning and evening after meal<br>Intervention2: Amrutha Sanjeevini Tablets plus Ojovardhini capsule <br>(Test Formulation B): Dosage form: Tablet and capsule Frequency : 14 days Twice a day morning and evening after meal<br>Control Intervention1: Standard of Care (Treatment C)<br>Recommended by ICMR, Government of India , guidelines: Recommended by ICMR, Government of India , guidelines<br>→ | 1 Improvement in Clinical symptoms on 5 point ordinal scale from baseline to end study i.e. 14 days <br/ ><br>â?¢ Change in LDH, TLC, CRP and D-DIMER from baseline to end of the study i.e. 14 days. <br/ ><br>Timepoint: Day 0 and Day 14→ | | | | Yes | False | | |
| → | CTRI/2021/02/031357 | 23 February 2021 | Breath analysis for Post COVID condition using E-nose | Study on Post COVID condition by breath analysis using E-nose. | | Department of Atomic and Molecular Physics Manipal Academy of Higher Education Manipal | 17-02-2021 | 20210217 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52837 | Not Recruiting | No | | | | 24-02-2021 | 200 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Santhosh Chidangil→ | | Department of Atomic and Molecular Physics,
Academic Block 5
MIT, Manipal
Udupi-576104 Department of Atomic and Molecular Physics,
Academic Block 5
MIT, Manipal
Udupi-576104→ | santhosh.cls@manipal.edu→ | 9880092297→ | Manipal Academy of Higher Education Manipal→ | Inclusion criteria: Healthy volunteers from 18 to 45 years are included. <br/ ><br>In Diseased volunteers who all suffer from post COVID are included.→ | Exclusion criteria: Patients with infectious diseases are excluded.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1.Minimal risk after collecting breathe. <br/ ><br>2.Minor increase over minimal risk or low riskTimepoint: Outcome will be assessed in 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/02/031370 | 23 February 2021 | Impact of COVID 19 on mental and respiratory functions of ventilated patients at six months post discharge | Neurocognitive and pulmonary outcomes of ventilated COVID patients in intensive care unit at 6 months post discharge A follow up study | | Kasturba Medical college | 17-02-2021 | 20210217 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52587 | Not Recruiting | No | | | | 28-02-2021 | 56 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sunil R→ | | Department of critical care medicine, ICU1, ICU complex, first floor, Accident and trauma block, Madhav Nagar, Manipal → | sunil.r@manipal.edu→ | 08095800142→ | Kasturba Medical college Manipal Academy of Higher education Manipal→ | Inclusion criteria: Ventilated patients more than 18 years of age discharged after recovering from COVID pneumonia→ | Exclusion criteria: Unwilling to participate in the study. <br/ ><br>Patients with background of psychiatric illness <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To study the sequel of COVID-19 on patients who was discharged from the hospital after getting treated for COVID pneumonia. Sequel will be assessed in terms of effects on long term neurocognitive symptoms, pulmonary, renal and endocrine morbidity in post intensive care COVID survivors.Timepoint: six months→ | | | | Yes | False | | |
| → | CTRI/2021/02/031375 | 23 February 2021 | Non Invasive Ventilation by Helmet mask vs. Facemask in Covid pneumonia patients. | Comparison of Effect of Non invasive ventilation delivered by Helmet Vs Face mask in patients with covid -19 infection | | Government Institute of Medical Sciences | 17-02-2021 | 20210217 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52608 | Not Recruiting | No | | | | 08-03-2021 | 30 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:→Randomized, Parallel Group Trial<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | DRANUPRIYA SAXENA→ | | DEPARTMENT OF ANAESTHESIA
GOVERNMENT INSTITUTE OF MEDICAL SCIENCE. GIMS GREATER NOIDA→ | anupriya.pmch@gmail.com→ | 9953090044→ | Government Institute of Medical Sciences→ | Inclusion criteria: 1 .Age > 18 years <br/ ><br>2 Patient requiring NIV for management of ARDS during covid 19 infection. <br/ ><br>ARDS defined by Berlin criteria. <br/ ><br>→ | Exclusion criteria: 1.Impending cardiopulmonary arrest. <br/ ><br>2.GCS <8 <br/ ><br>3.Absence of airway protective gag reflex. <br/ ><br>4.Elevated intracranial pressure. <br/ ><br>5.Tracheostomized patient. <br/ ><br>6.upper airway obstruction. <br/ ><br>7.Pregnancy. <br/ ><br>8.Denied consent. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Non invasive ventilation delivered by Helmet CPAP mask: Helmet CPAP mask will be used for delivering NIV to COVID 19 patients.<br>Duration- till patient is weaned off from ventilator<br>Control Intervention1: Non invasive ventilation Face mask: Facemask will be used for delivering NIV to COVID 19 patients.<br> Duration- till patient is weaned off from ventilator<br>→ | Proportion of patients getting intubated in both the groups.Timepoint: baseline, ihr, 4 hr, 24 hr, 48 hr→ | | | | Yes | False | | |
| → | CTRI/2021/02/031394 | 23 February 2021 | Demographic and Health parameters of patients with CIVID 19 positive status who required advanced level of respiratory assistance (need of ventilatory support) in Intensive Care Unit. | Clinical characteristics of patients with COVID 19
requiring advanced respiratory assistance (Invasive and Non Invasive Ventilation (NIV) : A Single Centre Retrospective Study in a Tertiary Care Hospital in North Eastern India. | | Dr Manas Pratim Borthakur | 18-02-2021 | 20210218 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51833 | Not Recruiting | No | | | | 24-02-2021 | 250 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Habib Md Reazaul Karim→ | | Room No A 001, Department of Anaesthesiology Critical Care and Pain Medicine All India Institute of Medical Sciences Raipur GE Road Tatibandh Chhattisgarh Department of Anaesthesiology Critical Care and Pain Medicine All India Institute of Medical Science→ | drhabibkarim@aiimsraipur.edu.in→ | | All India Institute of Medical Sciences Raipur→ | Inclusion criteria: All Patients admitted to our dedicated COVID hospitals and needed respiratory assistance in the form of Invasive or non invasive ventilation (NIV) in the intensive care unit(ICU).→ | Exclusion criteria: Patients Below 18 years and above 70 years. Patients who expired within 6 hours of Intensive Care Unit (ICU) admission.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | In hospital and ICU MortalityTimepoint: 2,7,10,28 days→ | | | | Yes | False | | |
| → | CTRI/2021/02/031424 | 23 February 2021 | A observational study to check the results of patients with COVID-19 infection treated with using high flow nasal cannula(using heat and
humified delivered oxygen through nasal cannula) | A retrospective observational study to determine the outcomes of patients with COVID-19 treated with using HFNC(high flow nasal cannula) | | Maharashtra medical research society | 19-02-2021 | 20210219 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51886 | Not Recruiting | No | | | | 01-03-2021 | 50 | Observational | Other
Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Dr Narendra Javadekar→ | | Ratna Memorial Hospital
968,senapati bapat road,pune 53 Ratna Memorial Hospital
968,senapati bapat road,pune 53→ | narenjavdekar@yahoo.co.in→ | 02025676861→ | Ratna Memorial Hospital ,968,Senapati bapat road Pune 53→ | Inclusion criteria: Covid 19 positive adult patients treated with HFNC→ | Exclusion criteria: Covid 19 negative patients.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J00-J99- Diseases of the respiratory system
→ | | The results of this study are expected to help understand the clinical and lab profile of patients with Covid-19 who were treated using HFNO and their outcomes interms of recovery ,requirement of invasive ventilation and mortalityTimepoint: It is a retrospective study.Approximately 4 days→ | | | | Yes | False | | |
| → | CTRI/2021/02/031420 | 23 February 2021 | Effectivenes of Siddha Supplement MAM Granules in the Management of Pre Symptomatic COVID 19 patients | An Open labelled RCT to Evaluate the
Efficacy and Safety of Siddha Supplement (MAM Granules) along with Standard Allopathy Treatment in the management of RT PCR Positive Pre Symptomatic COVID 19 patients
- MAMSRCT | | Central Council for Research in Siddha | 19-02-2021 | 20210219 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52957 | Not Recruiting | No | | | | 27-02-2021 | 60 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 2 | India→ | Dr Anurag Srivastava→ | | Department of Community Medicine,
Room.No 4088,Main Block,
Government Institute of Medical Sciences GIMS,Gautham Buddha Nagar,
Uttar Pradesh. Department of Community Medicine,
Room.No 4088,Main Block,
Government Institute of Medical Sciences GIMS,Gautham → | dranurag23@gmail.com→ | 7303884221→ | Government Institute of Medical Sciences GIMS→ | Inclusion criteria: 1. Laboratory Confirmed COVID â?? 19 with Asymptomatic Patient (as per ICMR Guidelines) 30 Patients in each group <br/ ><br>2. Aged 18-65 years <br/ ><br>3. Consenting to participate in the study and sign the informed consent <br/ ><br>→ | Exclusion criteria: 1. Patients with severe primary respiratory disease or other pathogenic microbial pneumonia <br/ ><br>2. Patient with Uncontrolled DM (â?¥ 350 mgs Fasting Sugar) Severe HT (180/120 mmHg as per JNC 8 Guidelines), Chronic BA (â?¥ 5 years Based on Clinical History), Renal Dysfunction (Known CKD â?¥ 5 years eGFR Stage â?¥ 3 as per NKA guidelines) <br/ ><br>3. Pregnant and Lactating mothers <br/ ><br>4. People who have history of allergic to Siddha medicine or intolerant to taking medication <br/ ><br>5. Patients participating in other COVID-19 clinical trials <br/ ><br>6. Patients already went under COVID 19 vaccination <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Siddha MAM Granules: 2gms with milk morning and night after food for 14 dayswith Standard Allopathy Care (Vit C & Zinc)<br>Control Intervention1: Standard Allopathy Care (Vit C & Zinc): milk morning and night after food for 14 days<br>→ | Reduction in incidence of clinical symptoms like fever, cough and breathlessness <br/ ><br>Negative conversion of SARS CoV - 2 by 14 days <br/ ><br>Reduction in Viral load of SARS CoV â?? 2 at the end of treatment <br/ ><br>Effect of drugs inflammatory markers (IL6) and other Immunity Markers at the end of treatment. <br/ ><br>Timepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2021/02/031409 | 23 February 2021 | A multicentre observational study to look into the practise of using non invasive ventilation in COVID-19 patients requiring ICU admission for respiratory support and their outcome in terms of their failure rate as well as exploiting the HACOR scale to predict NiV failure. | A multicentre observational study on the practise of non invasive ventilation in COVID-19 patients with De novo acute hypoxemic respiratory failure and utilising HACOR scale to predict failure - MONICA | | DR Saurav Sutradhar | 19-02-2021 | 20210219 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50943 | Not Recruiting | No | | | | 01-03-2021 | 500 | Observational | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Saurav Sutradhar→ | | Department of Critical Care Medicine, 5th Floor Central ICU,
KIMS, KIIT University Campus-5,Patia, Bhubaneswar → | drsauravindia@gmail.com→ | 8130241372→ | Kalinga Institute of Medical Sciences (KIMS)→ | Inclusion criteria: All the patients 18 years & above of age, suspected or tested positive for SARS-COV2 (RtPCR/RAT) being admitted to the <br/ ><br>Intensive care with de novo acute hypoxemic respiratory failure defined as recent onset respiratory failure as evidenced by a P/F <br/ ><br>ratio of less than equal to 300 mmHg, signs of respiratory distress along with the <br/ ><br>presence of pulmonary infiltrates on chest images, in the absence <br/ ><br>of chronic cardio-respiratory diseases, including extubation failure with hypoxemia and, in whom NiV was initiated and administered <br/ ><br>for at least 30 minutes. The underlying condition deemed to have caused DNAHRF and the reason for NiV initiation was adjudged <br/ ><br>by the treating Critical care physician and documented. ARDS will be diagnosed as per the BERLIN criteria.→ | Exclusion criteria: All patients with history of chronic cardio-respiratory illness as well as those who are home O2/Niv user. <br/ ><br>Patients who have failed extubation as well as those refusing NiV due to intolerance or with do not intubate orders.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. NiV failure rate <br/ ><br>2. Patient Outcome in terms of death or discharge from ICU among <br/ ><br> patients with Early and Late groups of NiV failure. <br/ ><br>Timepoint: Patients parameters will be assessed at baseline before Non invasive ventilation (NiV) initiation, thereafter at 1 hour, 24 hours and at 48 hours post NiV usage. <br/ ><br>The patient will be followed for a maximum period of 28 days in the ICU. <br/ ><br>→ | | | | Yes | False | | |
| NCT04331366 | 1 March 2021 | Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19 | GO2 PEEP Study: The Use of a Bidirectional Oxygenation Valve in the Management of Pulmonary Complications of COVID-19 | GO2 PEEP | Emory University | 31/03/2020 | 20200331 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04331366 | Not recruiting | No | 18 Years | N/A | All | April 8, 2020 | 2 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | United States | | Jeffrey Miller, MD | | | | Emory University |
<br> Inclusion Criteria:
<br>
<br> - COVID-19 positive
<br>
<br> - Oxygen saturation <92%
<br>
<br> - Able to provide informed consent
<br>
<br> - Receiving oxygen by non-rebreather mask
<br>
<br> - Not currently requiring intubation
<br>
<br> Exclusion Criteria:
<br>
<br> - Unable or unwilling to provide informed consent
<br>
<br> - Cognitive impairment
<br>
<br> - Rapidly decompensating status requiring urgent or emergent higher level of care
<br> | | COVID-19 | Device: GO2 PEEP MOUTHPIECE | Oxygen Saturation by Pulse Oximetry | 10/02/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04331366 | Yes | False | | Yes |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04715854 | 1 March 2021 | Effect on paO2 of Adding an Aerosol Mask Above the Nasal Canulas | Comparison of the Addition of an Aerosol Mask Above Nasal Canula on Oxygenation in Hypoxemic Failure | | Laboratory of Movement, Condorcet, Tournai, Belgium | 03/01/2021 | 20210103 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04715854 | Not recruiting | No | 18 Years | N/A | All | February 19, 2021 | 15 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor). | N/A | Belgium | | | | | | |
<br> Inclusion Criteria:
<br>
<br> Hypoxemia
<br>
<br> Exclusion Criteria:
<br>
<br> Hypercapnia
<br>
<br> Confusion
<br> | | Hypoxemic Respiratory Failure;Emergencies;Covid19 | Device: Mask | Change in PaO2 and PaCO2 | | | | Yes | False | | |
| → | NCT04741061 | 1 March 2021 | Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light | A Phase III, Randomized, Double-blind, Placebo-controlled International Multicenter Study to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik-Light Vector Vaccine in the Parallel Assignment of the Subjects in Prophylactic Treatment for SARS-?oV-2 Infection | SPUTNIK-LIGHT | Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation | 02/02/2021 | 20210202 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04741061 | Recruiting | No | 18 Years | 111 Years | All | February 19, 2021 | 6000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 3 | Russian Federation | | Elena Merkulova | | eam@ipharma.ru | +7 (495) 276 11 43 | |
<br> Inclusion Criteria:
<br>
<br> 1. Agree to sign the study informed consent form (ICF) before performing any study
<br> specific procedure
<br>
<br> 2. Adults = 18 years old
<br>
<br> 3. Negative COVID-19 PCR test result at the screening visit and negative
<br> immunochromatographic SARS-CoV-2 antigen rapid-test result at the enrolment
<br>
<br> 4. Consent for using effective methods of contraception during the study
<br>
<br> 5. No evidence of vaccine-induced reactions or complications after receiving
<br> immunobiological products in medical history
<br>
<br> 6. No acute infectious and/or respiratory diseases within at least 14 days before the
<br> enrolment
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Any previous vaccination/immunization (within 30 days before the enrollment) and any
<br> planned vaccination within 30 days after enrollment
<br>
<br> 2. Any previous or planning COVID-19 vaccination with any other Regulatory approved
<br> vaccine
<br>
<br> 3. Positive SARS-CoV-2 screening result obtained by PCR (at screening)
<br>
<br> 4. Administration of steroids (except hormonal contraceptives) and/or immunoglobulins or
<br> other blood products therapy not finished 30 days before the enrollment
<br>
<br> 5. Pregnancy or lactation
<br>
<br> 6. Acute coronary syndrome or stroke suffered less than one year before study enrollment
<br>
<br> 7. Tuberculosis, chronic systemic infections associated with Immunocompromised subjects
<br> in medical history
<br>
<br> 8. History of severe allergic reaction to drug or vaccine (anaphylactic shock, Quincke's
<br> edema, and other life-threatening allergic reactions), acute exacerbation of allergic
<br> diseases on screening and vaccination day
<br>
<br> 9. Chronic autoimmune disease and system collagenases in medical history
<br>
<br> 10. Organ transplantation and immunosuppressive therapy
<br>
<br> 11. Immunosuppressive therapy and corticosteroid system therapy within 3 months before the
<br> enrollment
<br>
<br> 12. Subjects with malignant neoplasms within 5 years before the enrollment
<br>
<br> 13. Splenectomy in the past medical history
<br>
<br> 14. Neutropenia (absolute neutrophil count <1,000 mm3 agranulocytosis, significant blood
<br> loss, severe anemia (hemoglobin <80 g/L), immunodeficient disease in the medical
<br> history within 6 months before the enrollment
<br>
<br> 15. The active form of a disease caused by the human immunodeficiency virus, syphilis,
<br> hepatitis B, or C
<br>
<br> 16. Acute Kidney injury or dialysis
<br>
<br> 17. Anorexia or dysnutrition
<br>
<br> 18. Tattoos at the injection site (deltoid muscle area), which in the medical opinion of
<br> the investigator does not allow assessing the local response to the vaccine/placebo
<br>
<br> 19. Alcohol or Drug abuse in medical history
<br>
<br> 20. Participation in other interventional clinical trial within the previous 90 days prior
<br> to vaccination and over duration of the trial
<br>
<br> 21. Any other condition that the investigator considers as a barrier to the trial
<br> completion as per the protocol
<br> | | COVID-19 Prevention | Biological: Sputnik Light;Other: Placebo | Incidence and severity of adverse events in study subjects;Percentage of study subjects with COVID-19 cases developed after vaccination→Percentage of study subjects with COVID-19 cases developed after vaccination;Incidence and severity of adverse events in study subjects | | | | Yes | False | | |
| NCT04756323 | 1 March 2021 | A Study to Evaluate Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above(COVID-19) | Evaluation of the Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (Vero Cells) in Healthy Population Aged 18 Years and Above: a Randomized, Double-blind, Placebo Parallel-controlled Phase II Clinical Trial | | Beijing Minhai Biotechnology Co., Ltd | 09/02/2021 | 20210209 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04756323 | Not recruiting | No | 18 Years | N/A | All | October 27, 2020 | 1000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | China | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Healthy permanent residents aged 18 years and above;
<br>
<br> 2. Subjects agree to sign the informed consent forms voluntarily;
<br>
<br> 3. Subjects are able to comply with the requirements of the clinical trial protocol;
<br>
<br> 4. Armpit temperature <= 37.0 degrees C;
<br>
<br> 5. Female subjects of childbearing age were not pregnant at the time of enrollment, were
<br> not breastfeeding, and had no birth plan within the first 3 months after enrollment;
<br> effective contraceptive measures had been taken within 2 weeks before enrollment.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Within 14 days before vaccination, subjects have been abroad and to
<br> villages/communities experienced COVID-19 epidemics, and in contact with COVID-19
<br> cases or suspected cases. Subjects are under isolation observation, or living in the
<br> villages/communities with COVID-19 cases or suspected cases;
<br>
<br> 2. Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to
<br> Information System of China Disease Prevention and Control);
<br>
<br> 3. Subjects with history of SARS virus infection by self-reported;
<br>
<br> 4. Positive in throat swab through RT-PCR;
<br>
<br> 5. Positive in SARS-CoV-2 antibody test;
<br>
<br> 6. Subjects with history of severe allergic reactions (such as acute anaphylaxis,
<br> urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to
<br> known composition of inactivated SARS-CoV-2 vaccine;
<br>
<br> 7. Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or
<br> family history;
<br>
<br> 8. Subjects with congenital malformations or developmental disorders, genetic defects,
<br> severe malnutrition, etc.;
<br>
<br> 9. Subjects with known or suspected diseases include: severe respiratory diseases, severe
<br> cardiovascular diseases, severe liver and kidney diseases, uncontrollable hypertension
<br> (systolic pressure >=140 mmHg, diastolic pressure >= 90 mmHg; subjects aged >= 60
<br> years with systolic pressure >=150 mmHg, diastolic pressure >=100 mmHg), diabetic
<br> complications, malignant tumors, various acute diseases or acute onset of chronic
<br> diseases;
<br>
<br> 10. Subjects diagnosed with congenital or acquired immune deficiency, HIV infection,
<br> lymphoma, leukemia or other autoimmune diseases;
<br>
<br> 11. Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency,
<br> coagulation disease);
<br>
<br> 12. Subjects receiving anti-TB treatment;
<br>
<br> 13. Subjects receiving other research drugs within 6 months before vaccination;
<br>
<br> 14. Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently
<br> oral or infusion for more than 14 days);
<br>
<br> 15. Subjects receiving blood products within 3 months before administration;
<br>
<br> 16. Subjects vaccinated with live attenuated vaccine within 14 days before vaccination;
<br>
<br> 17. Subjects vaccinated with other vaccine within 7 days before vaccination;
<br>
<br> 18. The researchers shall judge the other conditions which might be not in compliance with
<br> the requirements of this clinical trial.
<br> | | COVID-19 | Biological: medium dosage inactivated SARS-CoV-2 vaccine;Biological: high dosage inactivated SARS-CoV-2 vaccine;Biological: Placebo | The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA);The seropositive level of SARS-CoV-2 neutralizing antibody;The seropositive rates of SARS-CoV-2 neutralizing antibody | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04756869 | 1 March 2021 | Monitoring Health Care Workers at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology | Monitoring Health Care Workers at Risk for COVID-19 Using Wearable Sensors and Smartphone Technology | | University of Michigan | 15/02/2021 | 20210215 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04756869 | Not recruiting | No | 18 Years | N/A | All | April 28, 2020 | 226 | Observational | | | United States | | Sung Choi, MD, MS | | | | University of Michigan |
<br> Inclusion Criteria:
<br>
<br> - Adult Michigan Medicine health care workers age 18 years and older.
<br>
<br> - Health care workers who are involved in direct (in-person) face-to-face patient care
<br> or health care workers who are not involved in direct (in-person) face-to-face patient
<br> care but work on units where COVID-19 patients are/will likely be treated.
<br>
<br> - Possession of a smartphone (Apple or Android).
<br>
<br> - Ability to understand and demonstrate willingness to remotely sign a written informed
<br> consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Unwilling or unable to comply with the study procedures or to allow the study team
<br> access to health data.
<br> | | Covid19 | Other: COVID-19 Monitoring Using Wearable Sensors and Smartphone Technology | Feasibility of Wearing TempTraq Patch;Feasibility of Wearing Fitbit Watch | | | | No | False | | |
| → | NCT04757285 | 1 March 2021 | Copeptin and Psychological Stress of Medic During COVID-19 Pandemic | Evaluation of Serum Copeptin and Psychological Stress Level Among Healthcare Providers During COVID-19 Pandemic | COVID-19 | Alexandria University | 06/02/2021 | 20210206 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04757285 | Not recruiting | No | 24 Years | 37 Years | All | May 10, 2020 | 90 | Observational [Patient Registry] | | | Egypt | | | | | | |
<br> Inclusion Criteria:
<br>
<br> physicians and nurses under age of 37 years in good health
<br>
<br> Exclusion Criteria:
<br>
<br> - body mass index above 30
<br>
<br> - hypertension
<br>
<br> - Diabetes mellitus
<br>
<br> - females receiving contraceptive pills
<br> | | Psychological Stress;Hemostatic Disorder | | evaluation of psychological stress;determine stress hormones in serum cortisol and copeptin→determine stress hormones in serum cortisol and copeptin;evaluation of psychological stress | | | | No | False | | |
| NCT04757298 | 1 March 2021 | COVID-19 Treatment Cascade Optimization Study | Optimization of a New Adaptive Intervention to Increase COVID-19 Testing Among People at High Risk in an Urban Community | | University of Illinois at Urbana-Champaign | 15/02/2021 | 20210215 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04757298 | Recruiting | No | 18 Years | N/A | All | February 12, 2021 | 670 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | United States | ; ; | Liliane Windsor, PhD;Ellen Benoit, PhD;Ellen Benoit, PhD | | ;e.benoit@njcri.org;e.benoit@njcri.org | ;973 483-3444;973-483-3444 | University of Illinois Urbana Champaign; |
<br> Inclusion Criteria:
<br>
<br> - over 18 years of age
<br>
<br> - having high risk to contract COVID or develop related complications
<br>
<br> - able to speak English
<br>
<br> - able and willing to provide informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - under 18 years of age
<br>
<br> - not at high risk to contract COVID or develop related complications
<br>
<br> - unable to speak English
<br>
<br> - unable and unwilling to provide informed consent
<br> | | COVID-19 Testing | Behavioral: Navigation Services;Behavioral: Critical Dialogue;Behavioral: Brief Counseling;Behavioral: Referral and Digital Brochure | Completion of COVID-19 test | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT03256773 | 8 March 2021 | High Resolution Micro OCT Imaging | Imaging of Human Epithelial Airway Using a High Resolution Micro OCT Catheter (Functional Anatomic Imaging of CF Patients With Early Lung Disease Using Micro OCT) | | University of Alabama at Birmingham | 18/08/2017 | 20170818 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT03256773 | Recruiting | No | 14 Years | N/A | All | April 15, 2016 | 60 | Observational | | | United States | ; ; | Steven M Rowe;Heather Hathorne, PhD;Heather Hathorne, PhD | | ;hhathorne@peds.uab.edu;hhathorne@peds.uab.edu | ;205-638-9568;205-638-9568 | University of Alabama at Birmingham; |
<br> THE INCLUSION CRITERIA:
<br>
<br> - Patients diagnosed with CF or healthy normal controls with no respiratory disease
<br>
<br> - Patients must be over the age of 14
<br>
<br> - Patient must be able to give informed consent
<br>
<br> THE EXCLUSION CRITERIA:
<br>
<br> - Patients with recent respiratory infection requiring antibiotics or corticosteroids in
<br> the last 4 weeks (excluding routine perioperative antibiotics)
<br>
<br> - Patients with major sinus surgery that will alter the nasal anatomy and preclude
<br> imaging of the nares
<br>
<br> - Any condition that in the opinion of the investigator will alter the safety of pilot
<br> testing in the operating room
<br>
<br> - Female subjects who are pregnant
<br> | | Cystic Fibrosis;COPD;PCD - Primary Ciliary Dyskinesia;Covid19;Sinusitis | | feasibility of uOCT probe | | | | No | False | | |
| → | NCT04311697 | 8 March 2021 | Intravenous Aviptadil for Critical COVID-19 With Respiratory Failure | ZYESAMI (Aviptadil) for the Treatment of Critical COVID-19 With Respiratory Failure | COVID-AIV | NeuroRx, Inc. | 14/03/2020 | 20200314 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04311697 | Not recruiting | No | 18 Years | 100 Years | All | May 15, 2020 | 196 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States;Israel→Israel;United States | | Jonathan C Javitt, MD, MPH | | | | NeuroRx, Inc. |
<br> Inclusion Criteria:
<br>
<br> - Critical COVID-19 with respiratory failure
<br>
<br> - Physician determination that patient is on maximal conventional medical therapy
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnancy (pregnant women may apply for open label treatment under compassionate care
<br> IND
<br>
<br> 2. Age <18 years
<br>
<br> 3. Mechanical ventilation for more than 7 days in primary cohort. Mechanical
<br> ventilation>21 days in the exploratory cohort
<br>
<br> 4. Mean Arterial Pressure < 65 mm Hg with use of pressor per ICU protocol
<br>
<br> 5. Irreversible condition (other than COVID-19) with projected fatal course
<br>
<br> 6. ECMO
<br>
<br> 7. Current or recent (within 30 d) enrollment in another investigational trial of
<br> anti-IL6 drug;
<br>
<br> 8. Active diagnosis of Acquired immune deficiency syndrome;
<br>
<br> 9. Transplant patients currently immunosuppressed;
<br>
<br> 10. Chemotherapy-induced neutropenia (granulocyte count <1000/mm3);
<br>
<br> 11. Cardiogenic shock; congestive heart failure - NYHA Class 3 or 4;
<br>
<br> 12. Recent myocardial infarction - within last 6 months and troponin > 0.5
<br>
<br> 13. Anuria (urine output < 50 ml/d) or other signs of multi-organ failure
<br>
<br> 14. Severe liver disease with portal hypertension;
<br>
<br> 15. Recent stroke or head trauma within last 12 months
<br>
<br> 16. Increased intracranial pressure, or other serious neurologic disorder;
<br>
<br> 17. Liquid Diarrhea more than 3x/day; defined as more than 3 non-bloody watery stools
<br> within a 24-hour period, requiring additional fluid and electrolyte supplementation
<br> | | Critical COVID-19 With Respiratory Failure;Acute Respiratory Distress Syndrome (ARDS);Corona Virus Infection;Acute Lung Injury | Drug: Aviptadil by intravenous infusion + standard of care;Drug: Normal Saline Infusion + standard of care | Resolution of Respiratory Failure (Composite Endpoint) | | | | Yes | False | | |
| NCT04324736 | 8 March 2021 | "COVID-19 and Diabetes Outcomes" | "Coronavirus SARS-CoV2 and Diabetes Outcomes" : CORONADO | CORONADO | Nantes University Hospital | 25/03/2020 | 20200325 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04324736 | Not recruiting | No | N/A | N/A | All | March 10, 2020 | 5309 | Observational | | | France | | | | | | |
<br> Inclusion criteria
<br>
<br> - Patients admitted in a hospital center since 10th march 2020
<br>
<br> - Patients with COVID19 with biological proof (specific PCR) or with clinical and
<br> radiological diagnosis.
<br>
<br> - Patient with diabetes known before the admission
<br>
<br> - New onset diabetes discovered at admission (HbA1c value strictly greater than 6.5%)
<br>
<br> exclusion criteria
<br>
<br> - subjects opposed to the use of their data
<br>
<br> - minors, adults under guardianship, protected persons
<br>
<br> - subject having already been included in the CORONADO study (subject readmitted after
<br> discharge following the initial stay). Only the data of the first stay will be
<br> maintained.
<br> | | Coronavirus;Diabetes | Other: no interventional study | Assess the prevalence of severe forms among hospitalized patients with diabètes and COVID-19 | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04351724 | 8 March 2021 | Austrian CoronaVirus Adaptive Clinical Trial (COVID-19) | A Multicenter, Randomized, Active Controlled, Open Label, Platform Trial on the Efficacy and Safety of Experimental Therapeutics for Patients With COVID-19 (Caused by Infection With Severe Acute Respiratory Syndrome Coronavirus-2) | ACOVACT | Medical University of Vienna | 10/04/2020 | 20200410 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04351724 | Recruiting | No | 18 Years | 99 Years | All | April 16, 2020 | 500 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2/Phase 3 | Austria | ; | Bernd Jilma, MD;Bernd Jilma, MD | | ;klin-pharmakologie@meduniwien.ac.at | ;+4314040029810 | Medical University of Vienna; |
<br> Inclusion Criteria
<br>
<br> Laboratory confirmed (i.e. PCR-based assay) infection with SARS-CoV-2 (ideally but not
<br> necessarily
<br>
<br> =72 hours before randomization for "antiviral" treatments) OR radiological signs of
<br> COVID-19 in chest X-ray or computed tomography
<br>
<br> - Hospitalisation due to SARS-CoV-2 infection, except for sub-study B, which may also
<br> include outpatients with COVID-19
<br>
<br> - Requirement of oxygen support (due to oxygen saturation <94% on ambient air or >3%
<br> drop in case of chronic obstructive lung disease)
<br>
<br> - Informed Consent obtained, the patient understands and agrees to comply with the
<br> planned study procedures, except for sub-study C: obtaining informed consent may be
<br> impossible due to the severe condition of the patient and may be waived
<br>
<br> - =18 years of age
<br>
<br> - Sub-study A: not on chronic anticoagulation Sub-study B: Sub-study B: blood pressure
<br> =130/85mmHg in 2 consecutive measurements OR patients with established and treated
<br> hypertension
<br>
<br> - Sub-study B: Control group 1: Patients with suspicion of but negative tests for
<br> COVID-19. This group may consist of hospitalized and non-hospitalized patients.
<br>
<br> - Sub-study B: healthy volunteers
<br>
<br> - Sub-study C: Signs of respiratory deterioration and progressing inflammation: need for
<br> oxygen supplementation, non-invasive ventilation, high-flow oxygen devices or
<br> mechanical ventilation AND CRP levels >5mg/dL (for Pentaglobin only) and ICU admission
<br> (for Pentaglobin only)
<br>
<br> - For female patients with childbearing potential: willingness to perform effective
<br> measures of contraception during the study
<br>
<br> Exclusion Criteria
<br>
<br> - Moribund, or estimated life expectancy <1 month (e.g. terminal cancer, etc.)
<br>
<br> - Patient does not qualify for intensive care, based on local triage criteria
<br>
<br> - Pregnancy or breastfeeding
<br>
<br> - Severe liver dysfunction (e.g. ALT/AST > 5 times upper limit of normal)
<br>
<br> - Stage 4 chronic kidney disease or requiring dialysis for direct anticoagulant
<br> treatment
<br>
<br> - Allergy or intolerances to experimental substance (ineligibility for treatment arm),
<br> for Asunercept known hereditary fructose intolerance
<br>
<br> - Anticipated discharge from hospital within 48 hours (for any given reason)
<br>
<br> - Contraindications for treatment arm 2 (lopinavir/ritonavir): severe hepatic
<br> impairment, CYP3A4/5 metabolized drugs, as deemed relevant by treating physicians
<br>
<br> - Contraindications for treatment arm 3 (remdesivir): <40kg bodyweight
<br>
<br> - Known active HIV or viral hepatitis
<br>
<br> - Substudy A contraindications for rivaroxaban: active bleeding or bleeding diathesis,
<br> lesion or condition considered as major risk factor for bleeding, recent brain or
<br> spinal injury, recent brain or spinal or ophthalmic surgery, recent intracranial
<br> hemorrhage, known or suspected esophageal varices, arteriovenous malformations,
<br> vascular aneurysms, major intraspinal or intracerebral vascular abnormalities, ongoing
<br> therapeutic anticoagulation, which will be continued, according to clinical practice
<br>
<br> - Sub-study B contraindications for nitrendipine: chronic heart failure, allergies,
<br> hypersensitivities and intolerances, severe hepatic impairment and/or cholestasis,
<br> concomitant therapy with aliskirencontaining medications (for patients with diabetes
<br> mellitus or a GFR<60ml/min/1.73m2), known significant bilateral renal artery stenosis
<br> or renal artery stenosis of a solitary kidney
<br>
<br> - Sub-study C contraindications for IL-6 blockade: Contraindications: allergies and
<br> intolerances, active untreated diverticulitis, inflammatory bowel disease, any
<br> treatment with an IL-6 or IL-6R blocking drug (e.g. tocilizumab, sarilumab,
<br> siltuximab) <30 days before study inclusion.
<br>
<br> - Sub-study C: Known active tuberculosis.
<br>
<br> - Asunercept: females of childbearing potential
<br>
<br> - Sub-study C with Pentaglobin: Contraindications to Pentaglobin
<br> | | COVID-19 | Drug: Chloroquine or Hydroxychloroquine;Drug: Lopinavir/Ritonavir;Other: Best standard of care;Drug: Rivaroxaban;Drug: Thromboprophylaxis;Drug: Candesartan;Drug: non-RAS blocking antihypertensives;Drug: Remdesivir;Drug: Asunercept 400mg;Drug: Asunercept 100mg;Drug: Asunercept 25mg;Drug: Pentaglobin | sustained improvement (>48h) of one point on the WHO Scale | | | | Yes | False | | |
| → | NCT04353596 | 8 March 2021 | Stopping ACE-inhibitors in COVID-19 | Stopping ACE-inhibitors in COVID-19: A Randomized Controlled Trial | ACEI-COVID | Medical University Innsbruck | 14/04/2020 | 20200414 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04353596 | Not recruiting | No | 18 Years | N/A | All | April 20, 2020 | 216 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | Phase 4 | Germany;Austria;Germany;Austria→Austria;Germany;Austria;Germany | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Female and male patients competent to make a decision
<br>
<br> - Proven and symptomatic SARS-CoV2 infection = 5 days
<br>
<br> - Patient age = 18 years
<br>
<br> - Provided written informed consent
<br>
<br> - Chronic (= 1 month) ACEI/ARB therapy for treatment of arterial hypertension, diabetes
<br> mellitus, heart failure or coronary artery disease
<br>
<br> - Stable hemodynamic conditions allowing to stop or continue treatment with ACEI/ARB
<br> (systolic blood pressure =180mmHg)
<br>
<br> Exclusion Criteria:
<br>
<br> - Women capable of bearing children as well as pregnant and breastfeeding women
<br>
<br> - Participant in another interventional trail
<br>
<br> - At screening visit, no oral medication intake possible
<br>
<br> - Advanced heart failure NYHA Stage III-IV
<br>
<br> - Left ventricular ejection fraction <30% or NTproBNP =600pg/mL in case of clinical
<br> signs of heart failure
<br>
<br> - Acute coronary syndrome = 3 months
<br>
<br> - Severe arterial hypertension (concomitant use of more than 4 different
<br> antihypertensive drug classes)
<br>
<br> - Acute respiratory distress syndrome with need for mechanical ventilation
<br>
<br> - Patients who at not capable of home blood pressure monitoring
<br>
<br> - Patients who cannot be switched to an alternative medication
<br> | | SARS-CoV-2;COVID-19 | Drug: ACE inhibitor, angiotensin receptor blocker | Combination of maximum Sequential Organ Failure Assessment (SOFA) Score and death;Composite of admission to an intensive care unit (ICU), the use of mechanical ventilation, or all-cause death | | | | Yes | False | | |
| NCT04354272 | 8 March 2021 | Evaluation of Dental Emergency Treatments During COVID19 Crisis | Evaluation of the Management of Dental Emergencies During COVID 19 Crisis | URGDENTCOVID | Assistance Publique - Hôpitaux de Paris | 10/04/2020 | 20200410 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04354272 | Not recruiting | No | 18 Years | N/A | All | April 21, 2020 | 503 | Observational | | | France | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Age = 18 years
<br>
<br> - Patient reachable by telephone during the week following his / her care in the service
<br>
<br> - Collection of the consent of the patient for his participation in research
<br>
<br> - Good understanding of the French language
<br>
<br> Exclusion Criteria:
<br>
<br> -Patient with communication difficulties or difficulties in understanding the French
<br> language"
<br> | | Orofacial Pain;Orofacial Edema;Dental Trauma;Oral Infection | Other: Questionnaire | Pain score evolution measured by a 0-10 numeric scale (NS) where 0 is no pain and 10 the worst pain imaginable | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04701710 | 8 March 2021 | Prophylaxis Covid-19 in Healthcare Agents by Intensive Treatment With Ivermectin and Iota-carrageenan | A Randomized Trial - Intensive Treatment Based in Ivermectin and Iota-carrageenan as Prophylaxis for Covid-19 In Healthcare Agents | Ivercar-Tuc | Maria de los Angeles Peral de Bruno | 07/01/2021 | 20210107 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04701710 | Not recruiting | No | 18 Years | 60 Years | All | October 15, 2020 | 300 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1/Phase 2 | Argentina | | Rossana E Chahla, MD, Ph.D. | | | | Ministry of Health, Tucuman, Argentina |
<br> Inclusion Criteria:
<br>
<br> - Personnel who perform patient care and administrative tasks:
<br>
<br> - medical personnel,
<br>
<br> - nurses,
<br>
<br> - kinesiologists,
<br>
<br> - orderlies,
<br>
<br> - administrative,
<br>
<br> - cleaning personnel.
<br>
<br> Exclusion Criteria:
<br>
<br> - People under 18 years of age,
<br>
<br> - Pregnant or actively breastfeeding women,
<br>
<br> - Presenting symptoms related to COVID-19 disease,
<br>
<br> - Concurrent autoimmune or chronic disease,
<br>
<br> - Immunosuppression,
<br>
<br> - Active infectious diseases,
<br>
<br> - History of previous SARSCoV-2 infection confirmed by RT-PCR or rapid test.
<br> | | Covid19;SARS (Severe Acute Respiratory Syndrome) | Drug: Ivermectin / Iota-Carrageenan | Pearson's Chi-square and proportion test. | | | | No | False | | |
| → | NCT04706156 | 8 March 2021 | Oral Side Effects of COVID-19 Vaccine | Oral Side Effects of COVID-19 Vaccine: A Multicenter Cross-sectional Study | | Masaryk University | 11/01/2021 | 20210111 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04706156 | Recruiting | No | 18 Years | N/A | All | January 27, 2021 | 1540 | Observational | | | Czechia;Germany;Slovakia;Czechia;Germany;Slovakia→Slovakia;Germany;Czechia;Slovakia;Germany;Czechia | ; | Abanoub Riad, DDS;Abanoub Riad, DDS | | ;abanoub.riad@med.muni.cz | ;+420721046024 | Masaryk University; |
<br> Inclusion Criteria:
<br>
<br> - Healthcare workers who received COVID-19 vaccine during the last 30 days.
<br>
<br> - Participating subjects should be at least 18-year-old and able to give their informed
<br> consent independently.
<br>
<br> Exclusion Criteria:
<br>
<br> - The healthcare workers who did not receive the COVID-19 vaccine recently.
<br>
<br> - Non-healthcare workers who received the COVID-19 vaccine recently.
<br> | | Oral Manifestations;Covid19;Vaccine Adverse Reaction | Biological: COVID-19 Vaccine | Oral Side Effects | | | | Yes | False | | |
| NCT04713176 | 8 March 2021 | Efficacy and Safety of DWJ1248 With Remdesivir in Severe COVID-19 Patients | A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase III Study to Evaluate the Efficacy and Safety of DW1248 With Remdesivir in Severe COVID-19 Patients | | Daewoong Pharmaceutical Co. LTD. | 14/01/2021 | 20210114 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04713176 | Recruiting | No | 19 Years | N/A | All | February 2, 2021 | 1022 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 3 | Korea, Republic of | | Jae-Hyun Jeon | | mdjjh@nmc.or.kr | | |
<br> Inclusion Criteria:
<br>
<br> - Adults over the age of 19 as of the signed date in written consent
<br>
<br> - Subjects with COVID-19 according to RT-PCR test(within 10 days)
<br>
<br> - Subjects who need to be hospitalized and injected Remdesivir
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects who cannot orally administer the investigational products
<br>
<br> - Subjects who requiring mechanical ventilation or ECMO
<br>
<br> - Acute Respiratory Distress Syndrome(ARDS), shock, multiple organ dysfunction syndrome
<br>
<br> - Subjects who need administration of immunosuppressants
<br>
<br> - Subjects who are allergic or sensitive to investigational products or its ingredients
<br>
<br> - Crcl < 30 mL/min or eGFR < 30 mL/min/1.73m^2
<br>
<br> - AST or ALT >= 5xULN
<br>
<br> - Subjects who have been identified with uncontrolled concomitant diseases or
<br> conditions, including significant mental illness and social conditions, that may
<br> affect compliance with clinical trial procedures according to the determination of the
<br> investigators
<br> | | Severe COVID-19 | Drug: DWJ1248 with Remdesivir;Drug: Placebo with Remdesivir | Rate of mortality or ECMO patients | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04359901 | 16 March 2021 | Sarilumab for Patients With Moderate COVID-19 Disease | Sarilumab for Patients With Moderate COVID-19 Disease: A Randomized Controlled Trial With a Play-The-Winner Design | | Westyn Branch-Elliman | 20/04/2020 | 20200420 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04359901 | Not recruiting | No | 18 Years | N/A | All | April 10, 2020 | 50 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | | Westyn Branch-Elliman, MD | | | | VA Boston Healthcare System |
<br> Study subjects will be inpatients with confirmed SARS-CoV-2 testing. Testing is performed
<br> at the discretion of the treating physician. Only Veterans will be enrolled.
<br>
<br> Inclusion Criteria:
<br>
<br> 1. Positive testing for novel coronavirus SARS-CoV-2019
<br>
<br> 2. Patients with moderate COVID-19 disease as defined clinically:
<br>
<br> 1. Score of 1-3 (out of 3) on a modified Brescia COVID respiratory severity score
<br> (BCRSS), elements of which include wheezing or inability to speak complete
<br> sentences without effort, respiratory rate =22, O2 saturation = 94% with or
<br> without supplemental oxygen, or requiring =2L supplemental oxygen to maintain O2
<br> Sat >94% in patients without previously documented hypoxia or baseline
<br> oxygenation requirement; either is equal to one point on the score) all within a
<br> 24-hour period prior to enrollment, and/or any worsening of chest X-ray (CXR)
<br> findings after COVID-19 diagnosis
<br>
<br> 2. Worsening of baseline oxygenation by at least 3%, or increase in oxygen
<br> requirement by at least 2L, in patients with pre-existing hypoxemia or receiving
<br> supplemental oxygen chronically.
<br>
<br> 3. The BCRSS risk calculation score is available at:
<br> https://www.mdcalc.com/brescia-covid-respiratory-severity-scale-bcrss-algorithm
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Critical disease, defined by need for mechanical ventilation
<br>
<br> 2. Expected death within 48 hours
<br>
<br> 3. Patients taking any of the following for chronic inflammatory diseases:
<br> glucocorticoids equivalent to prednisone > 10 mg/day (methylprednisolone > 8 mg/day,
<br> dexamethasone > 2 mg/day), a JAK inhibitor (tofacitinib, baricitinib, upadacitinib),
<br> or a biologic
<br>
<br> 1. Use of chronic inhaled steroids is NOT an exclusion
<br>
<br> 2. Current or recent short-term use of glucocorticoids for chronic conditions such
<br> as COPD or gout is NOT an exclusion.
<br>
<br> 3. Current use of glucocorticoids for COVID-19 is NOT an exclusion
<br>
<br> 4. Use of biologics for non-inflammatory diseases is NOT an exclusion
<br>
<br> 4. Receipt of any IL-6 inhibitor within 3 months prior to enrollment in the trial
<br>
<br> 5. Pregnancy, due to lack of fetal monitoring capabilities
<br>
<br> 6. Patients enrolled in other interventional clinical trials, including for COVID-19.
<br> Patients enrolled in non-interventional studies or receiving non-FDA-approved drugs
<br> for compassionate use are not excluded.
<br>
<br> 7. Patients whose goal of care is comfort measures only
<br>
<br> 8. Inability to provide informed consent, or absence of a legally authorized
<br> representative to provide informed consent.
<br>
<br> 9. Severe psychiatric disease that prevents compliance with typical medical care.
<br>
<br> 10. Initial positive test for active infection with novel coronavirus SARS-CoV-2019 was >4
<br> weeks prior to current admission.
<br> | | COVID | Biological: SARILUMAB | Intubation or death | | | | Yes | False | | |
| → | NCT04363463 | 16 March 2021 | Impact of Prone Position in Patients Under Spontaneous Breathing on Intubation or Non-invasive Ventilation or Death Incidence During COVID-19 Acute Respiratory Distress | Impact of Prone Position in Patients Under Spontaneous Breathing on Intubation or Non-invasive Ventilation or Death Incidence During COVID-19 Acute Respiratory Distress | PROVID-19 | Centre Hospitalier Régional d'Orléans | 22/04/2020 | 20200422 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04363463 | Recruiting | No | 18 Years | 85 Years | All | August 28, 2020 | 400 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | France;Monaco;France;Monaco→Monaco;France;Monaco;France | ; | Mai-Anh NAY, Dr;Aurélie DESPUJOLS | | ;aurelie.despujols@chr-orleans.fr | ;+33238744071 | CHR Orléans; |
<br> Inclusion Criteria:
<br>
<br> - Patients aged from 18 to 85 years old
<br>
<br> - With COVID-19 documentation
<br>
<br> - Undergoing oxygen therapy (nasal cannula, medium or high concentration mask or high
<br> flow nasal oxygen therapy)
<br>
<br> - Able to move to PP by him/herself or with minimal assistance
<br>
<br> - Written consent
<br>
<br> - Hospitalized in COVID medical department for less than 72 hours
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnant (positive pregnancy test during screening) or breastfeeding women
<br>
<br> - Patient on long-term oxygen therapy or Continuous Positive Airway Pressure (CPAP) or
<br> Non-Invasive Ventilation (NIV) at home
<br>
<br> - Chronic Obstructive Pulmonary Disease (COPD) Patient stage 3 or 4
<br>
<br> - Patient with known chronic diffuse interstitial lung disease
<br>
<br> - Patient with neuromuscular pathology
<br>
<br> - Contraindication to the PP (recent thoracic trauma, pneumothorax, orthopaedic fracture
<br> preventing mobilization, ...)
<br>
<br> - Deep vein thrombosis of the lower limbs or pulmonary embolism with effective
<br> anticoagulation for less than 48 hours
<br>
<br> - Hemodynamic instability (MAP < 65 mm Hg) persisting for more than 1 hour
<br>
<br> - Respiratory rate greater than 40 cycles per minute
<br>
<br> - Excessive use of accessory respiratory muscles (as judged by the clinician)
<br>
<br> - Indication for curative NIV (acute pulmonary edema or acute hypercapnic respiratory
<br> failure)
<br>
<br> - Intestinal Occlusive Syndrome
<br>
<br> - Patient unable to protect upper airway
<br>
<br> - Inability to understand French or to follow instructions for the prone position.
<br>
<br> - Person under guardianship
<br>
<br> - Protected Majors
<br>
<br> - Not affiliated to French social security
<br>
<br> - Decision not to forgo life sustaining therapy
<br>
<br> - Patient discharged from an intensive care unit and has been treated by invasive or
<br> non-invasive mechanical ventilation at 2 pressure levels during the resuscitation
<br> stay.
<br> | | COVID19;Oxygen Therapy;Prone Position;Spontaneous Ventilation;Respiratory Distress Syndrome | Other: prone position | Percent age of patients who will have endotracheal intubation or non-invasive ventilation at two pressure levels and/or die, in each of the 2 randomization groups. | | | | Yes | False | | |
| NCT04371848 | 16 March 2021 | Impact of the COVID-19 Pandemic on Diet Quality and Food Insecurity: a NutriQuébec Sub-study | Impact of the COVID-19 Pandemic on Diet Quality and Food Insecurity Among Adults From the Province of Québec in Canada: a NutriQuébec Sub-study | | Laval University | 22/04/2020 | 20200422 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04371848 | Not recruiting | No | 18 Years | N/A | All | April 16, 2020 | 2465 | Observational | | | Canada | | Benoît Lamarche | | | | University Laval |
<br> Inclusion Criteria:
<br>
<br> - Adults aged 18 and over with a residential address in Québec (Canada)
<br>
<br> - Be able to read and understand French or English
<br>
<br> - Have access to Internet (with a computer, electronic tablet or cell phone)
<br>
<br> - Have an active email address
<br>
<br> Exclusion Criteria:
<br>
<br> - None
<br> | | Eating Habits | | Change in food insecurity;Change in diet quality | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04463823 | 16 March 2021 | "NORPLASMA" Covid-19 Convalescent Plasma Treatment Monitoring Study | Covid-19 Convalescent Plasma Used for Treatment of Patients in Norway - a Monitoring Study | MONITOR | Oslo University Hospital | 03/07/2020 | 20200703 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04463823 | Recruiting | No | 18 Years | N/A | All | July 6, 2020 | 500 | Observational | | | Norway | ; | Lise Sofie Haug Nissen-Meyer, Ph.D.;Lise Sofie Haug Nissen-Meyer, Ph.D | | ;lisoha@ous-hf.no | ;+47 22117828 | Oslo University Hospital; |
<br> Inclusion Criteria:
<br>
<br> - patients treated with covid-19 convalescent plasma
<br>
<br> - patients who has provided informed consent or where nearest relative has given consent
<br>
<br> Exclusion Criteria:
<br>
<br> - patients included in other clinical studies of covid-19 treatment
<br>
<br> - consent not given
<br>
<br> All eligible patients should be invited.
<br> | | COVID | | observation | | | | Yes | False | | |
| → | NCT04465604 | 16 March 2021 | Hypertonic Saline for COVID-19 Symptoms | HYPERTONIC SALINE COATED FACE MASK FOR REDUCING RESPIRATORY SYMPTOM SEVERITY IN PATIENTS WITH COVID-19 | | King Faisal Specialist Hospital & Research Center | 02/07/2020 | 20200702 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04465604 | Recruiting | No | 18 Years | N/A | All | February 1, 2021 | 50 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Saudi Arabia | ; ; | Ali Alshanqeeti, MD;Ali Alshanqeeti, MD;Ali Alshanqeeti, MD | | ;ashanqeeti@kfshrc.edu.sa;ashanqeeti@kfshrc.edu.sa | ;+966114427094;+966114427094 | King Faisal Specialsit Hospital and Research Center; |
<br> Inclusion Criteria:
<br>
<br> - Age 18 years and older
<br>
<br> - confirmed diagnosis of COVID-19 by PCR and
<br>
<br> - Any of the following
<br>
<br> - cough
<br>
<br> - shortness of breath
<br>
<br> - Respiratory rate more than 20 per minute or
<br>
<br> - oxygen saturation 90% or less on room air
<br>
<br> Exclusion Criteria:
<br>
<br> - Age younger than 18 years
<br>
<br> - Pregnancy
<br>
<br> - Participation in other COVID-19 intervention trial
<br> | | COVID-19 | Other: Wearing surgical face mask sprayed with hypertonic saline | Improvement of respiratory symptoms;Improvement of respiratory signs→Improvement of respiratory signs;Improvement of respiratory symptoms | | | | Yes | False | | |
| NCT04469491 | 16 March 2021 | Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study | Treatment of COVID-19 by Nebulization of Inteferon Beta 1b Efficiency and Safety Study | COV-NI | Centre Hospitalier Universitaire, Amiens | 13/07/2020 | 20200713 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04469491 | Recruiting | No | 18 Years | N/A | All | September 20, 2020 | 146 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). | Phase 2 | France | ; | Jean-Philippe Lanoix, MD;Jean-Philippe Lanoix, MD | | ;lanoix.jean-philippe@chu-amiens.fr | ;(33)322668813 | CHU Amiens; |
<br> Inclusion Criteria:
<br>
<br> - Age = 18 years old
<br>
<br> - Patient with laboratory-confirmed SARS-CoV-2 infection as determined by PCR < 96 h (at
<br> initial diagnosis or persistent carriage <96 h)
<br>
<br> - Hospitalized patient with COVID-19 requiring oxygen therapy
<br>
<br> And targeting in phase B :
<br>
<br> - Patients under oxygen therapy such as nasal cannula/mask or non-invasive ventilation
<br> with paO2/FiO2 > 200 mmHg.
<br>
<br> - Patients hospitalized for less than 7 days.
<br>
<br> - Patients with symptoms for less than 10 days or RT-PCR (<96h) with Cycle Treshold <
<br> 25.
<br>
<br> - Social security coverage
<br>
<br> - signed informed consent (by patient or their legally authorized representative)
<br>
<br> Exclusion Criteria:
<br>
<br> - Hypersensitivity to natural or recombinant interferon-ß
<br>
<br> - Hypersensitivity to human albumin or mannitol
<br>
<br> - Recent suicide attempt
<br>
<br> - Decompensation of liver failure
<br>
<br> - age < 18 years
<br>
<br> - Pregnant or nursing.
<br>
<br> - Patients managed on an outpatient basis (i.e. not initially hospitalized).
<br>
<br> - Parenteral IFN treatment. In periode B, addition of new exclusion criteria
<br>
<br> - Patients with kidney transplant
<br>
<br> - Immunocompromised patients
<br>
<br> - Patients with severe systemic disease constantly threatening their vital prognosis
<br> (ASA = IV: e.g. severe ARF, advanced cancer pathology, recent myocardial IDM, severe
<br> valvular dysfunction, dependence on parenteral nutrition on central line, shock,
<br> sepsis, trauma, ...).
<br>
<br> - Patients in septic shock.
<br>
<br> - Patients with documented fungal infection.
<br>
<br> - Patients on mechanical ventilation.
<br>
<br> - Patients hospitalized for COVID-19 for more than 7 days.
<br> | | COVID-19;INTERFERON;NEBULIZATION | Drug: inhaled type I interferon;Drug: WFI water nebulization | Variation oxygen requirement score between day 0 and day15;oxygen requirement score at day 15;oxygen requirement score at day 0 | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04569786 | 16 March 2021 | Dose Ranging Trial to Assess Safety and Immunogenicity of V590 (COVID-19 Vaccine) in Healthy Adults (V590-001) | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Safety and Immunogenicity of V590 in Healthy Adults | | Merck Sharp & Dohme Corp. | 24/09/2020 | 20200924 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04569786 | Not recruiting | No | 18 Years | N/A | All | October 29, 2020 | 232 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 1 | United States | | Medical Director | | | | Merck Sharp & Dohme Corp. |
<br> Inclusion Criteria:
<br>
<br> - Is in overall good health based on medical history, physical examination, and vital
<br> sign (VS) measurements performed prior to randomization, as assessed by the
<br> investigator.
<br>
<br> - Is in overall good health based on laboratory safety tests obtained at the screening
<br> visit.
<br>
<br> - Has a body mass index (BMI) =30 kg/m2 inclusive (after rounding to the nearest whole
<br> number).
<br>
<br> - Parts 1 and 2 (Panels A-H) only: Has negative testing for severe acute respiratory
<br> syndrome coronavirus 2 (SARS-CoV-2) based on both antibody and reverse transcription
<br> polymerase chain reaction (RT-PCR), at screening and upon start of domiciling.
<br>
<br> - Part 3 (Panel I) only: Has positive serology (antibody) testing for SARS-CoV-2, also
<br> with negative SARS CoV-2 RT-PCR testing at screening and upon start of domiciling, and
<br> without symptoms of respiratory infection for at minimum 3 weeks preceding screening.
<br>
<br> - Has been practicing social distancing for at least two weeks prior to planned start of
<br> domiciling and has had no close contacts with known active SARS-CoV-2 infection in
<br> that time period.
<br>
<br> - Is male or female, from 18 years to 54 years of age inclusive (Parts 1 and 3 [Panels
<br> A-D, I]) or = 55 years of age (Part 2 [Panels E-H]) at the time of signing the
<br> informed consent.
<br>
<br> - Male participants are eligible to participate if they agree to the following during
<br> the intervention period and for at least 2 months after administration of study
<br> intervention: be abstinent from heterosexual intercourse as their preferred and usual
<br> lifestyle and agree to remain abstinent OR agree to use contraception unless confirmed
<br> to be azoospermic (vasectomized or secondary to medical cause).
<br>
<br> - A female participant is eligible to participate if she is not pregnant or
<br> breastfeeding, and at least one of the following conditions applies: is not a woman of
<br> childbearing potential (WOCBP), or is a WOCBP and using an acceptable contraceptive
<br> method, or is abstinent from heterosexual intercourse as their preferred and usual
<br> lifestyle. A WOCBP must have a negative highly sensitive pregnancy test before the
<br> first dose of study intervention. If a urine test cannot be confirmed as negative, a
<br> serum pregnancy test is required.
<br>
<br> Exclusion Criteria:
<br>
<br> - Has a known hypersensitivity to any component of V590 or placebo.
<br>
<br> - Has any known or suspected active clinically significant autoimmune disease or
<br> immunosuppressive condition, acquired or congenital, as determined by medical history
<br> and/or physical examination.
<br>
<br> - Has thrombocytopenia or other coagulation disorder contraindicating intramuscular
<br> vaccination or repeated venipuncture.
<br>
<br> - Has history or current evidence of any condition, therapy, laboratory abnormality, or
<br> other circumstance that might expose the participant to risk by participating in the
<br> study, confound the results of the study or interfere with the participant's
<br> participation for the full duration of the study.
<br>
<br> - Has a history of ongoing liver disease or, at the time of screening, has any one of
<br> the following: Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >
<br> 1.5 × Upper Limit of Normal (ULN), alkaline phosphatase and direct bilirubin > ULN
<br> (total bilirubin may be up to 2 × ULN as long as direct bilirubin is equal to or below
<br> the ULN), or prothrombin time (PT) international normalized ratio (INR) > 1.25.
<br>
<br> - Has a history of asthma or allergic asthma that required systemic corticosteroids in
<br> the previous year.
<br>
<br> - Has a history of Guillain-Barré syndrome.
<br>
<br> - Has a history of diabetes mellitus, requiring medication at the time of assessment, OR
<br> has a hemoglobin A1c = 6.5.
<br>
<br> - Has a history of any medical condition that would put the participant at risk for
<br> severe SARS-CoV-2 disease as judged by the investigator.
<br>
<br> - Has any ongoing, symptomatic, acute or chronic illness requiring medical or surgical
<br> care or any condition that is immunosuppressive.
<br>
<br> - Is mentally or legally incapacitated, has significant emotional problems at the time
<br> of screening visit or expected during the conduct of the study or has a history of
<br> clinically significant psychiatric disorder of the last 5 years.
<br>
<br> - Has a history of cancer (malignancy).
<br>
<br> - Participant has an estimated glomerular filtration rate (eGFR) =60 mL/min/1.73 m^2.
<br>
<br> - Has a history of significant multiple and/or severe allergies or has had an
<br> anaphylactic reaction or significant intolerability to a vaccine or prescription or
<br> non prescription drugs or food as judged by the investigator.
<br>
<br> - Is positive for hepatitis B surface antigen, hepatitis C antibodies or human
<br> immunodeficiency virus (HIV)-1 or 2 antibodies. Individuals with antibodies to
<br> hepatitis C may be enrolled if hepatitis C viral load is negative and there is no
<br> evidence of or history of liver disease.
<br>
<br> - Had major surgery, donated or lost 1 unit of blood (approximately 500 mL) within 4
<br> weeks prior to the pre-study (screening) visit.
<br>
<br> - A WOCBP who has a positive urine or serum pregnancy test before vaccination.
<br>
<br> - A WOCBP who is breastfeeding.
<br>
<br> - Has any unstable chronic medical condition, including one that has resulted in change
<br> in therapy (medication or other) in the 30 days prior to randomization or
<br> hospitalization in the previous year or might be predicted to result in
<br> hospitalization in the year after enrollment.
<br>
<br> - Has received or is expected to receive any SARS-CoV-2 vaccine or other coronavirus
<br> vaccine during the study (except V590), is using investigational agents for
<br> prophylaxis of SARS-CoV-2 or is taking any systemic antiviral medications.
<br>
<br> - Has received any intra-articular steroid injections within the 3 months prior to study
<br> vaccination or is expected to require intra-articular steroid injection during the
<br> study.
<br>
<br> - Is receiving immunosuppressive therapy or has received immunosuppressive therapy
<br> within 6 months of enrollment.
<br>
<br> - Has received a blood transfusion or blood products, including immunoglobulin, in the 3
<br> months before anticipated study vaccination.
<br>
<br> - Is expected to be receiving or is currently receiving antipyretic or analgesic
<br> medication on a daily or every other day basis from randomization through Day 7
<br>
<br> - Has ever participated in an investigational study of a SARS-CoV-2 vaccine, a
<br> coronavirus vaccine, or an antiviral or other biologic product intended for the
<br> treatment of COVID-19.
<br>
<br> - Has participated in another vaccine study with | | Coronavirus Disease (COVID-19) | Biological: V590;Other: Placebo | Geometric Mean Titers for Serum Neutralizing Antibodies as Measured by Plaque Reduction Neutralization Test (Panels A - H);Percentage of Participants with at Least 1 Serious Adverse Event;Percentage of Participants with at Least 1 Medically Attended Adverse Event;Percentage of Participants with at Least 1 Unsolicited Adverse Event;Percentage of Participants with at Least 1 Solicited Systemic Adverse Event;Percentage of Participants with at Least 1 Solicited Injection Site Adverse Event | | | | Yes | False | | |
| → | NCT04576351 | 16 March 2021 | The Norwegian Study of Nervous System Manifestations and Sequelae After COVID-19 | The Norwegian Study of Nervous System Manifestations and Sequelae After COVID-19 | NeuroCovid | Oslo University Hospital | 10/09/2020 | 20200910 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04576351 | Recruiting | No | 18 Years | N/A | All | September 1, 2020 | 150 | Observational | | | Norway | ; ; | Anne Hege Aamodt, MD, PhD;Hanne F Harbo, MD,PhD,Prof;Anne Hege Aamodt, MD, PhD | | ;;a.h.aamodt@medisin.uio.no | ;;95867270 | Oslo University Hospital;Oslo University Hospital; |
<br> Sub cohort 1:
<br>
<br> Inclusion Criteria:
<br>
<br> - Consenting adults (age =18 years) hospitalized with definite COVID-19 included in the
<br> WHO: The NOR Solidarity multicenter trial on the efficacy of different anti-viral
<br> drugs in SARS CoV-2 infected patients and willingness to participate in the NeuroCOVID
<br> study.
<br>
<br> Exclusion Criteria:
<br>
<br> - If still alive, no willingness and ability to participate in all follow-up
<br> examinations.
<br>
<br> Sub cohort 2:
<br>
<br> Inclusion Criteria:
<br>
<br> - Consenting adults (age =18 years) with COVID-19 and new neurological,
<br> neuropsychological or neuropsychiatric symptoms and/or signs or participants from
<br> other COVID-19 studies than the NOR Solidary Study.
<br>
<br> Exclusion Criteria:
<br>
<br> - If still alive, no willingness and ability to participate in all follow-up
<br> examinations.
<br>
<br> All participants in both sub cohorts will after the visit by neurologists be assessed by
<br> neuropsychologists and psychiatrist at 6- and 12-month follow-up if the following criteria
<br> are fulfilled:
<br>
<br> 1. Sufficient Norwegian or English speaking in order to fulfill the tests.
<br>
<br> 2. MoCA score > 18.
<br>
<br> 3. Hospital has C-L psychiatrist/neuropsychologists that participate in the study or
<br> collaborate with C-L psychiatrist/psychiatrist/clinical psychologists at nearby
<br> hospitals.
<br> | | Covid19 | Other: Observation | Rate of peripheral and central nervous affection;Rate of peripheral and central nervous affection;Rate of psychiatric disorders at 6-months follow-up;Rate of psychiatric disorders at 12-months follow-up;Neuropsychological function at 6-months follow up;Neuropsychological function at 12-months follow up and change in function from 6 to 12 months.→Neuropsychological function at 12-months follow up and change in function from 6 to 12 months.;Neuropsychological function at 6-months follow up;Rate of psychiatric disorders at 12-months follow-up;Rate of psychiatric disorders at 6-months follow-up;Rate of peripheral and central nervous affection;Rate of peripheral and central nervous affection | | | | Yes | False | | |
| NCT04590430 | 16 March 2021 | Study to Assess the Safety, Tolerability, and Pharmacokinetics of HFB30132A Against COVID-19 in Healthy Adults | A Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose First-in-Human Study Investigating the Safety, Tolerability, and Pharmacokinetics of Intravenously Administered HFB30132A, a Monoclonal Antibody Directed Against SARS-CoV-2, in Healthy Adult Subjects | | HiFiBiO Therapeutics | 08/10/2020 | 20201008 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04590430 | Not recruiting | No | 18 Years | 60 Years | All | October 20, 2020 | 24 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 1 | United States | | Leela Vrishabhendra, MD | | | | Medpace, Inc. |
<br> Inclusion Criteria:
<br>
<br> - Subject is a healthy male or female subject, aged between 18 to 60 years (both
<br> inclusive). Health is defined as no clinically relevant abnormalities identified by
<br> Investigator's decision based on a detailed medical history, full physical
<br> examination, including blood pressure, heart rate, respiratory rate, and body
<br> temperature measurement, electrocardiogram (ECG) and clinical laboratory tests prior
<br> to the study drug administration.
<br>
<br> - Subject is confirmed as negative by SARS-CoV-2 RT-PCR testing on screening and prior
<br> to admission to the unit.
<br>
<br> - Subject voluntarily agrees to participate in this study and has given written informed
<br> consent prior to undergoing any of the screening procedures.
<br>
<br> - Willing and able to comply with all scheduled visits, treatment plan, clinical
<br> laboratory tests, lifestyle guidelines, methods of contraception, including COVID-19
<br> social distancing guidelines as described in Section 5.7.2 (under "Hygiene") from
<br> signing of informed consent through end of study on Day 180.
<br>
<br> - Female subjects of childbearing potential must not be planning a pregnancy or be
<br> pregnant or lactating. All female subjects must have a negative result for the
<br> pregnancy tests performed at screening and admission.
<br>
<br> - Female subjects of childbearing potential (including perimenopausal females who have
<br> had a menstrual period within 1 year prior to screening) must agree to use a reliable
<br> method of contraception until study completion and for at least 4 weeks following
<br> their final study visit on Day 180. Reliable contraception is defined as a method
<br> which results in a low failure rate, i.e., less than 1% per year when used
<br> consistently and correctly, such as hormonal contraception (oral, implant, injection,
<br> ring, or patch) and intrauterine contraceptive devices (IUDs) at least 3 months prior
<br> to Screening or a vasectomized partner. Note: Complete abstinence from sexual
<br> intercourse is acceptable.
<br>
<br> - Female subject is of non-childbearing potential defined as surgically sterile (i.e.
<br> documented bilateral tubal ligation, bilateral oophorectomy, or complete hysterectomy)
<br> or at least 12 months postmenopausal (defined with no menses without an alternative
<br> medical cause and follicle stimulating hormone test in the post-menopausal range at
<br> the screening visit.
<br>
<br> - Male subjects with partners of childbearing potential must have had surgical
<br> sterilization (vasectomy) at least 26 weeks prior to screening or use a male barrier
<br> method of contraception (i.e. male condom with spermicide) during any sexual
<br> intercourse, from Study Day -1 (beginning of confinement) until 3 months after the
<br> final Follow-up Visit on Day 270. Note: complete abstinence from sexual intercourse is
<br> acceptable.
<br>
<br> - Male subjects must agree to abstain from sperm donation from initial study drug
<br> administration through 3 months after the last Follow-up Visit on Day 180.
<br>
<br> Exclusion Criteria:
<br>
<br> - History of any illness or history or presence of clinically significant pathology
<br> that, in the opinion of the investigator, might confound the results of the study or
<br> pose an additional risk in administering study drug(s) to the subject or collecting
<br> samples for analysis. This includes, but is not limited to, a history of relevant drug
<br> or food allergies; history of clinically significant cardiovascular, pulmonary,
<br> autoimmune, psychiatric or central nervous system disease, or of cancer with systemic
<br> spread in remission for less than 5 years.
<br>
<br> - Use of any medications started within 14 days (or 5 half-lives, whichever is longer)
<br> prior to study drug administration including, prescription medications, nutritional
<br> supplements, and over-the-counter medications except for vitamin supplements, hormonal
<br> contraception, and recommended doses of acetaminophen, aspirin or ibuprofen
<br>
<br> - Hospitalization for any reason within 60 days prior to the screening visit
<br>
<br> - History of or positive human immunodeficiency virus (HIV) screen result, or positive
<br> blood test for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody
<br> (HBcAb). Subjects with positive hepatitis C virus (HCV) antibody at the screening
<br> visit are only eligible if they have previously completed treatment for HCV and have
<br> confirmatory negative test for HCV RNA.
<br>
<br> - History of drug or alcohol abuse within 1 year prior to screening, or positive test
<br> for drugs of potential abuse at screening and admission, where alcohol abuse is
<br> defined as regular consumption exceeding 7 drinks/ week for women, and 14 drinks/ week
<br> for men.
<br>
<br> - Participation (defined as receipt of dose of investigational agent) in any clinical
<br> research study evaluating another investigational drug or therapy within 30 days or at
<br> least 5 half-lives (whichever is longer), of the investigational drug prior to the
<br> screening visit
<br>
<br> - Blood donation of approximately 1 pint (500 mL) within 60 days prior to dosing, or
<br> donation of more than 1 unit of plasma within 30 days prior to the start of study drug
<br> dosing
<br>
<br> - Receipt of any transfused blood products within 60 days of the screening visit.
<br>
<br> - Any history of receiving treatment or vaccination against SARS-CoV-2
<br>
<br> - Febrile illness within 28 days prior to the first dose of study drug, or other signs
<br> or symptoms consistent with SARS-CoV-2 infection in the judgement of the Investigator
<br> in the 14 days prior to the first dose of study drug.
<br> | | Healthy | Drug: HFB30132A;Other: Placebo | Number of participants with treatment emergent serious adverse events (TESAEs);Number of participants with treatment emergent adverse events (TEAE) of special interest;Number of participants with treatment-emergent adverse events (TEAE);Maximum observed serum concentration (Cmax);Steady-state volume of distribution (Vss);Systemic clearance (CL);Terminal half-life (T1/2);Area under the concentration vs. time curve (AUC0-last), AUC0-8);Time of maximum serum concentration (Tmax);Minimum observed serum concentration (Cmin) | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04780594 | 16 March 2021 | Impact of the COVID-19 Pandemic on the Surgical Activity of Bellvitge University Hospital | Impact of the SARS-CoV-2 (COVID-19) Pandemic on the Morbidity and Mortality of Patients Undergoing Surgery at Bellvitge University Hospital | | Hospital Universitari de Bellvitge | 01/03/2021 | 20210301 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04780594 | Not recruiting | No | 18 Years | N/A | All | February 13, 2020 | 2530 | Observational | | | Spain | | Maria Jose MJ Colomina, PhD | | | | Head of the Department |
<br> Inclusion Criteria:
<br>
<br> - All surgical patients operated, both elective scheduled and emergent cases
<br>
<br> Exclusion Criteria:
<br>
<br> - Minor-intermediate surgery that involves discharge from the hospital on the same day
<br> of the surgery from the Pre-pandemic period.
<br>
<br> - Procedures related to medical treatment or complications of COVID-19 patients, such as
<br> chest tubes, extracorporeal oxygenation or tracheostomy.
<br>
<br> - Those scheduled elective surgery patients in the Covid period that resulted RT-PCR
<br> positive, surgery was posponed, were not considered eligible for the analysis.
<br> | | Covid19;Surgery--Complications;Nosocomial Infection | Procedure: The study evaluates all surgical patients operated, both elective scheduled and emergent cases | Register the post-surgical complications | | | | No | False | | |
| → | NCT04781400 | 16 March 2021 | Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People | Bidirectional, Upbeat Communication and Differentiated, Distanced Care for Young People | BUDDY | Desmond Tutu HIV Foundation | 22/02/2021 | 20210222 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04781400 | Recruiting | No | 13 Years | 24 Years | All | February 8, 2021 | 600 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: None (Open Label). | N/A | South Africa | ; ; | Linda-Gail Bekker;Dr Itzikowitz;Gina Itzikowitz | | ;gina.itzikowitz@hiv-research.org;gina.itzikowitz@hiv-research.org | ;+27836014632;0836014632 | Desmond Tutu HIV Foundation; |
<br> Inclusion Criteria:
<br>
<br> Young people living with HIV who meet all of the following criteria will be eligible for
<br> inclusion into this study:
<br>
<br> 1. Speak isiXhosa and or English, residing in the Khayelitsha /Mitchell's Plain area
<br>
<br> 2. 13-24 years (inclusive)
<br>
<br> 3. Willing and able to provide informed telephonic or in person consent
<br>
<br> 4. Initiated ART at one of two health facilities and are currently in HIV care (i.e.
<br> received ART and had a viral load measurement in the past six months)
<br>
<br> 5. Regular access to a mobile phone with SMS or WhatsApp capacity (can include the phone
<br> of a parent/caregiver if the participant is <18 years or does not have their own
<br> phone)
<br>
<br> Young people living without HIV from the same communities who meet all of the following
<br> criteria will be eligible for inclusion into this study:
<br>
<br> 1. Speak isiXhosa and or English, residing in the Khayelitsha / Mitchell's Plain area
<br>
<br> 2. 13-24 years (inclusive)
<br>
<br> 3. Willing and able to provide informed telephonic or in person consent
<br>
<br> 4. Has not previously tested positive for HIV and self-reports being HIV negative (i.e.,
<br> not known to be living with HIV).
<br>
<br> 5. Regular access to a mobile phone (can include the phone of a parent/caregiver if the
<br> participant is <18 years or does not have their own phone)
<br>
<br> Exclusion Criteria:
<br>
<br> Young people living with HIV who meet any of the following criteria will be excluded from
<br> this study:
<br>
<br> 1. Not 13-24 years (inclusive)
<br>
<br> 2. Unwilling or unable to provide informed telephonic or in person consent
<br>
<br> 3. Not currently receiving ART care at a Desmond Tutu Health Foundation health facility
<br>
<br> 4. No regular access to a mobile phone with SMS or WhatsApp capacity
<br>
<br> 5. Planning to relocate in the next 6 months
<br>
<br> Young people living without HIV from the same communities who meet any of the following
<br> criteria will be excluded this study:
<br>
<br> 1. Not 13-24 years (inclusive)
<br>
<br> 2. Unwilling or unable to provide informed telephonic or in person consent
<br>
<br> 3. Previously tested positive for HIV or is known to be living with HIV
<br>
<br> 4. No regular access to a mobile phone
<br>
<br> 5. Planning to relocate in the next 6 months
<br> | | HIV Infections;Covid19;Health Care Utilization;Gender-based Violence | Behavioral: Mobile phone support;Behavioral: Remote service delivery model | Acceptability of a remote service delivery and mobile support intervention assessed by the number of participants opting in to receive courier delivery of ART.;Engagement in HIV care assessed by serial measurements of HIV Viral load.;Changes in Gender Based Violence (GBV) incidence as a result of COVID lock-down measures as assessed by self reported surveys.→Changes in Gender Based Violence (GBV) incidence as a result of COVID lock-down measures as assessed by self reported surveys.;Engagement in HIV care assessed by serial measurements of HIV Viral load.;Acceptability of a remote service delivery and mobile support intervention assessed by the number of participants opting in to receive courier delivery of ART. | | | | Yes | False | | |
| NCT04782336 | 16 March 2021 | Sample Collection Study to Aid Evaluation of an Influenza A/B, Respiratory Syncytial Virus & COVID-19 Virus POC Test | Sample Collection to Facilitate the Performance Evaluation of the LumiraDx Point of Care Device for the Detection of Influenza A/B, Respiratory Syncytial Virus (RSV) & COVID-19 (SARS-COV-2 Virus) | INFORM | LumiraDx UK Limited | 17/02/2021 | 20210217 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04782336 | Recruiting | No | N/A | N/A | All | December 12, 2020 | 3500 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | United Kingdom | ; | Samer Elkhodair;Jayne Ellis | | ;inform@lumiradx.com | ;01786 430411 | University College London Hospitals; |
<br> Inclusion Criteria:
<br>
<br> - Preliminary assessment of the patient by the Investigator/Designee should be
<br> suggestive of Influenza and/or COVID-19 and/or RSV at the time of the study visit.
<br> This may include referral to a testing facility.
<br>
<br> - The patient will be completing or has completed a Standard of Care (SOC) Influenza
<br> A/B, COVID-19 and/or an RSV test on the day of study. This SOC sampling can be
<br> conducted prior or post the patient consenting to this study.
<br>
<br> - Written Informed Consent must be obtained prior to study enrolment:
<br>
<br> - A participant who is 16 years or older must be willing to give written informed
<br> consent and must agree to comply with study procedures.
<br>
<br> - The Legal Guardian or Legal Authorised Representative of a participant who is
<br> under the age of 16 must give written informed consent and agree to comply with
<br> study procedures. Active written assent should be obtained from children of
<br> appropriate intellectual age (as determined by the consent taker in accordance
<br> with GCP).
<br>
<br> N.B. Inclusions 1 & 2 are not applicable to Group B sites.
<br>
<br> Exclusion Criteria:
<br>
<br> - The patient underwent a nasal wash/aspirate as part of standard of care testing during
<br> their current visit.
<br>
<br> - The patient is undergoing treatment currently and/or within the past 14 days of the
<br> study visit with an inhaled influenza vaccine (FluMist®) or anti-viral medication,
<br> which may include but is not limited to Amantadine (Symmetrel®), Rimantadine
<br> (Flumadine®), Zanamivir (Relenza®), Oseltamivir (Tamiflu®), or Baloxavir Marboxil
<br> (Xofluza™).
<br>
<br> - The patient is undergoing treatment currently or had undergone within the past 14 days
<br> of the study visit with RSV-related medication which may include but is not limited to
<br> Ribavirin (Virazole), RSV-IGIV (RespiGam) or palivizumab (Synagis).
<br>
<br> - The patient is currently receiving or has received within the past thirty (30) days of
<br> the study visit an experimental biologic, drug, or device including either treatment
<br> or therapy.
<br>
<br> - The patient does not have the capacity to consent as determined by the Research Team.
<br>
<br> - The patient is deemed to be unsuitable for research at the Research Team's discretion.
<br>
<br> N.B. Paediatric participants may only enrol at Group A sites, in which enrolment is limited
<br> to once/week.
<br> | | Covid19;RSV Infection;Influenza Type A;Influenza Type B | Other: Group A (Sample Collection);Other: Group B (Sample Collection);Diagnostic Test: On-Site Testing (LumiraDx) | Collection of Nasal Swabs, Throat Swabs and Saliva Samples across a range of demographics. | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04786353 | 16 March 2021 | Long COVID Kids DK - Investigating Long-term Covid-19 | Long COVID Kids DK - Investigating Long-term Hospitalizations, GP Visits, Co-morbidities, Drug Prescriptions and Symptoms in Danish Children With Covid-19 | | Rigshospitalet, Denmark | 01/03/2021 | 20210301 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04786353 | Not recruiting | No | N/A | N/A | All | April 2021 | 300000 | Observational [Patient Registry] | | | | ; | Selina K Berg, PhD;Selina K Berg, PhD | | ;Selina.Kikkenborg.Berg.01@regionh.dk | ;35459526 | 29190623; |
<br> Inclusion Criteria:
<br>
<br> - must be included in the covid-19 monitoring database
<br>
<br> Exclusion Criteria:
<br>
<br> -
<br> | | Covid-19 | Other: LongCOVIDkidsDK | Prescribed drugs;Diagnoses;Hospitalizations;Contacts to the general practitioner | | | | Yes | False | | |
| → | NCT04786483 | 16 March 2021 | The Effect of Laughter Therapy on Students in the COVID-19 Pandemic | The Effect of Laughter Therapy on Students' Anxiety, Life Satisfaction and Psychological Well-being in the Covid-19 Pandemic | | Zonguldak Bulent Ecevit University | 24/02/2021 | 20210224 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04786483 | Not recruiting | No | N/A | N/A | All | November 1, 2020 | 80 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Double (Participant, Care Provider). | N/A | Turkey | | Sule Ecevit Alpar, Doctorate | | | | Üniversite |
<br> Inclusion Criteria:
<br>
<br> - A student of the Faculty of Health Sciences, Department of Nursing and enrolled in the
<br> fall semester,
<br>
<br> - Who has not studied laughter yoga before or did not do laughter yoga,
<br>
<br> - It will create students who agree to participate in the research.
<br>
<br> Exclusion Criteria:
<br>
<br> - Being a foreign national,
<br>
<br> - Having a situation where laughter yoga is not recommended (having surgery in the
<br> abdominal region in the last three months, uncontrolled hypertension, chronic cough,
<br> incontinence, acute back pain, acute mental disorders, consumption of antipsychotic
<br> drugs, glaucoma, hernia, epilepsy),
<br>
<br> - Students with simultaneous participation in any complementary treatment methods will
<br> be excluded.
<br> | | Laughter Yoga;Anxiety;Life Satisfaction;Psychological Well-being;COVID-19 | Other: Laughter Theraphy | psychological well-being;life satisfaction;Psychological Well-being→Psychological Well-being;life satisfaction;psychological well-being | | | | No | False | | |
| NCT04787536 | 16 March 2021 | Perioperative Cognitive Trajectories in Deferred Surgery (CoTELE-SURGE) | Preoperative and Postoperative Cognitive TrajEctories in oLdEr Patients With Deferred SURGEry Due to the COVID-19 Emergency: a Prospective Cohort Study | CoTELE-SURGE | McMaster University | 03/03/2021 | 20210303 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04787536 | Recruiting | No | 65 Years | N/A | All | June 10, 2020 | 300 | Observational | | | Canada | ; ; | Maura Marcucci, MD;Maura Marcucci, MD;Maura Marcucci, MD | | ;marcum2@mcmaster.ca;marcum2@mcmaster.ca | ;9055274322;9055274322 | McMaster Univesity; |
<br> Inclusion Criteria:
<br>
<br> 1. age 65 years or greater;
<br>
<br> 2. patient scheduled to perform noncardiac elective surgery expected to require at least
<br> an overnight stay in hospital after surgery;
<br>
<br> 3. surgery deferred, with a known or probable surgery date in =6 weeks;
<br>
<br> 4. informed consent provided.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. patient undergoing cardiac surgery or cranial neurosurgery;
<br>
<br> 2. known history of dementia;
<br>
<br> 3. unavailability of tablet or computer with an internet connection for remote
<br> assessment; 4. patient unable to interact with a tablet or computer due to language,
<br> visual, or hearing impairment, or any severely limited mobility of the upper limb
<br> joints;
<br>
<br> 5. patient unable to understand spoken or written English; 6. surgery delayed for an
<br> intercurrent clinical event
<br> | | Postoperative Cognitive Dysfunction;Depressive Symptoms;Postoperative Pain | Procedure: Non-cardiac surgery | Change in perioperative cognitive trajectories assessed using the Cogstate Brief Battery (CBB) | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-001224-33-DE | 17 March 2021 | Systematic study of the medicine hydroxychloroquine against placebo for the treatment of adult patients with acute coronavirus disease 2019 – COVID-19 | Randomized controlled trial of hydroxychloroquine versus placebo for the treatment of adult patients with acute coronavirus disease 2019 – COVID-19 | | Universitätsklinikum Tübingen | 24/03/2020 | 20200324 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001224-33 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 25/03/2020 | 220 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany | Project management,Diane Egger-Adam | | Wilhelmstr. 27 | diane.egger-adam@uni-tuebingen.de | +4970712982191 | Universitätsklinikum Tübingen | Inclusion criteria: <br>• Written informed consent<br>• Age above 18 years<br>• Women of childbearing age only: Must agree to practice continuous effective contraception for the duration of the study (a method which results in a failure rate less than 1% per year)<br>• Disease severe enough to require hospitalisation<br>• QTc interval lower than 450 msec<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 195<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 25<br> | Exclusion criteria: <br>• Respiratory rate >24/min<br>• Pregnancy or lactation<br>• Weight <50 kg<br>• Hemodynamic/rhythm instability<br>• Acute myocardial infarction Type 1<br>• Use of concomitant medications that prolong the QT/QTc interval.<br>• Any regular concomitant medication which is contraindicated in the use together with HCQ<br>• Hypersensitivity to Hydroxychloroquine, Chloroquine or other 4-Aminoquinolines<br>• Pre-existing retinopathy or maculopathy <br>• Known Glucose-6-phosphate dehydrogenase deficiency (haemolytic anaemia, Favism)<br>• Haematopoietic systems diseases<br>• Myasthenia gravis<br>• Any other significant disease, disorder or finding which, in the opinion of the investigator, may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data<br><br> | Acute coronavirus disease 2019 <br>MedDRA version: 20.1
Level: PT
Classification code 10053983
Term: Corona virus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Quensyl<br>Pharmaceutical Form: Capsule<br>Pharmaceutical form of the placebo: Capsule<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: One interim analysis for evaluating the primary efficacy endpoint is planned for this study. The interim analysis will be done when 40% of events have accrued. In case the interim analysis shows a HR > 1.93 (nominal p < 0.0018), efficacy is shown and the trial may be stopped. Final analysis upon completion of the trial and final database lock.;Primary end point(s): Primary efficacy endpoint: Viral clearance defined as time to sustained SARS-CoV-2-specific RNA copy number =100, measured by real time reverse-transcription polymerase chain reaction in throat swabs<br><br><br>;Secondary Objective: Exploratory objectives are to assess the effect of infection and HCQ treatment on clinical outcome, cardiac function, mucosal, humoral and cellular immune response including single cell phenotype and RNA expression, effect on anti-viral defense, assessment of chronic symptoms and quality of life. ;Main Objective: Primary objective: Effect of HCQ on in vivo viral clearance. | | | | Yes | True | parent | |
| → | EUCTR2020-001420-34-DK | 17 March 2021 | Senicapoc treatment of COVID-19 positive patients in intensive care | Senicapoc in COVID-19 Patients with Severe Respiratory Insufficiency
– A Randomized, Open-Label, Phase II Trial - COVIPOC | | Aarhus University | 01/04/2020 | 20200401 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001420-34 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 14/04/2020 | 46 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Standard treatment<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Denmark | www.Clinicaltrials.gov | | Ole Worms Allé 4 | us@biomed.au.dk | +4560202613 | Aarhus University | Inclusion criteria: <br>1) COVID-19<br>2) Age =18 years<br>3) Respiratory insufficiency<br>4) ICU admission<br><br>COVID-19 will be defined as a positive polymerase chain reaction (PCR)<br>test for SARS-CoV-2, either from a nasal or throat swab or from tracheal<br>suctioning, within the last 14 days prior to ICU admission. Respiratory<br>insufficiency will be defined as a need for supplemental oxygen of at<br>least 10 L/min in patients without a need for mechanical ventilation or<br>invasive or non-invasive mechanical ventilation with a FiO2 = 40%. An<br>ICU will be defined per local practices.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 23<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 23<br> | Exclusion criteria: <br>1) Severe heart failure (ejection fraction < 30%)<br>2) Severe renal insufficiency (eGFR < 30 mL/min/1.73m2)<br>3) Severe hemodynamic instability (noradrenalin dose > 0.3 µg/kg/min)<br>4) Prior enrollment in the trial<br>5) Pregnancy<br>6) Allergy to senicapoc<br>7) Inability to take enteral medication<br>8) More than 24 hours since ICU admission<br>9) Limitations of care<br>10) Anticipated death within 24 hours<br>Severe heart failure will pragmatically be defined solely on the basis of<br>the latest measured or estimated ejection fraction obtained via<br>echocardiography (or other image modalities). If no ejection fraction is<br>available, it will be assumed that the patient does not have severe heart<br>failure. Renal insufficiency will be defined based on the latest estimated<br>glomerular filtration rate (eGFR). If a patient is receiving renal<br>replacement therapy, this will likewise be considered severe renal<br>insufficiency. Hemodynamic instability will be defined based on a need<br>for high-dose continuous vasopressor therapy specifically a noradrenalin<br>dose > 0.3 µg/kg/min. If the patient is receiving other vasopressors<br>instead of or in addition to noradrenalin, a noradrenaline-equivalent<br>dose will be estimated based on prior formulas.39 In fertile women (age<br>< 50 years) a negative urine-hCG or plasma-hCG must be present before<br>enrolment. In order to optimize the chances of patients surviving to 72<br>hours (the time of the primary outcome), patients with limitations of<br>care (including limitations related to mechanical ventilation and renal<br>replacement therapy but not cardiopulmonary resuscitation) and<br>patients with anticipated death within 24 hours, as judged by the<br>treating clinician, will be excluded.<br><br> | Infection with COVID19 <br>MedDRA version: 21.1
Level: PT
Classification code 10001052
Term: Acute respiratory distress syndrome
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Senicapoc<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: senicapoc<br>CAS Number: 289656-45-7<br>Other descriptive name: SENICAPOC<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 10-<br><br> | Secondary Objective: Not applicable;Main Objective: To treat respiratory insufficiency due to COVID19;Timepoint(s) of evaluation of this end point: The primary measure of the PaO2/FIO2 ratio will be done 72-hours after<br>randomization. This time point was chosen to allow adequate time for<br>the interventions to work while avoiding missing data due to deaths.;Primary end point(s): The primary outcome will be the PaO2/FiO2 ratio 72 hours after<br>randomization. The PaO2/FiO2 ratio will be calculated based on the<br>arterial gas closest to the time-point of 72 hours after randomization. If<br>no clinically-indicated arterial gas is performed or planned within ± 2<br>hours of the time-point, an arterial gas will be performed. The ratio will<br>be calculated based on the PaO2 from the arterial gas and the FiO2 at<br>the same time point. If the patient is receiving mechanical ventilation<br>(invasive or non-invasive) or is receiving oxygen through a high-flow<br>nasal cannula, the FiO2 will be obtained directly from the ventilator. If<br>the patient is receiving oxygen through a regular nasal cannula, the FiO2<br>will be calculated based on the following: FiO2 = 21% + 4%/(l/min) x<br>O2 flow in l/min. For face masks, with or without reservoir, the FiO2 will<br>be estimated based on the approach used in EPIC2.40,41 Patients who<br>dies prior to the 72-hour time point will be handled as described in<br>Section 6.2.3.<br><br>The PaO2/FiO2 ratio is a commonly used measure of illness severity in<br>patients with acute lung injury and ARDS and is used to define these two<br>conditions.17 Furthermore, the PaO2/FiO2 ratio is associated with<br>mortality17,20 making it a potential useful surrogate outcome for phase<br>II trials. Although data is sparse, a lower PaO2/FiO2 ratio has also been<br>associated with worse outcomes in patients with COVID-19.10,42<br>Furthermore, animal studies in mice have shown that Senicapoc<br>improves the PaO2/FiO2 ratio in experimentally induced ARDS (Section<br>1.3.2). Based on these considerations, and the fact that hypoxemic<br>respiratory failure is the hallmark of severe COVID-19 infection, the<br>PaO2/FiO2 ratio is a reasonable primary outcome for a phase II trial.<br>The primary measure of the PaO2/FiO2 ratio will be done 72-hours after<br>randomization. This time-point was chosen to allow adequate time for<br>the intervention to work while avoiding missing data due to deaths.→Secondary Objective: Not applicable;Main Objective: To treat respiratory insufficiency due to COVID19;Primary end point(s): The primary outcome will be the PaO2/FiO2 ratio 72 hours after<br>randomization. The PaO2/FiO2 ratio will be calculated based on the<br>arterial gas closest to the time-point of 72 hours after randomization. If<br>no clinically-indicated arterial gas is performed or planned within ± 2<br>hours of the time-point, an arterial gas will be performed. The ratio will<br>be calculated based on the PaO2 from the arterial gas and the FiO2 at<br>the same time point. If the patient is receiving mechanical ventilation<br>(invasive or non-invasive) or is receiving oxygen through a high-flow<br>nasal cannula, the FiO2 will be obtained directly from the ventilator. If<br>the patient is receiving oxygen through a regular nasal cannula, the FiO2<br>will be calculated based on the following: FiO2 = 21% + 4%/(l/min) x<br>O2 flow in l/min. For face masks, with or without reservoir, the FiO2 will<br>be estimated based on the approach used in EPIC2.40,41 Patients who<br>dies prior to the 72-hour time point will be handled as described in<br>Section 6.2.3.<br><br>The PaO2/FiO2 ratio is a commonly used measure of illness severity in<br>patients with acute lung injury and ARDS and is used to define these two<br>conditions.17 Furthermore, the PaO2/FiO2 ratio is associated with<br>mortality17,20 making it a potential useful surrogate outcome for phase<br>II trials. Although data is sparse, a lower PaO2/FiO2 ratio has also been<br>associated with worse outcomes in patients with COVID-19.10,42<br>Furthermore, animal studies in mice have shown that Senicapoc<br>improves the PaO2/FiO2 ratio in experimentally induced ARDS (Section<br>1.3.2). Based on these considerations, and the fact that hypoxemic<br>respiratory failure is the hallmark of severe COVID-19 infection, the<br>PaO2/FiO2 ratio is a reasonable primary outcome for a phase II trial.<br>The primary measure of the PaO2/FiO2 ratio will be done 72-hours after<br>randomization. This time-point was chosen to allow adequate time for<br>the intervention to work while avoiding missing data due to deaths.;Timepoint(s) of evaluation of this end point: The primary measure of the PaO2/FIO2 ratio will be done 72-hours after<br>randomization. This time point was chosen to allow adequate time for<br>the interventions to work while avoiding missing data due to deaths. | | | | Yes | True | parent | |
| → | EUCTR2020-003904-15-DK | 17 March 2021 | BCG vaccine for seniors to prevent infections during the COVID-19 pandemic. | Using BCG vaccine to enhance non-specific protection of senior citizens during the COVID-19 pandemic. A randomized clinical trial. - BCG-DENMARK-SENIOR | | University of Southern Denmark | 11/08/2020 | 20200811 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-003904-15 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 27/08/2020 | 1900 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: yes<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Denmark | Dep. of Clinical Research, OPEN | | J. B. Winsloews Vej 9 | open.adm@rsyd.dk | | University of Southern Denmark | Inclusion criteria: <br>In order to be eligible to participate in this study, a subject must meet the following criteria: =65 years old.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) no<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 1900<br> | Exclusion criteria: <br>A potential subject who meets any of the following criteria will be excluded from participation in this study:<br>• Known allergy to (components of) the BCG vaccine or serious adverse events in relation to prior BCG administration<br>• Previous Mycobacterium tuberculosis (M. tuberculosis) infection or known active or latent infection with M. tuberculosis or other mycobacterial species<br>• Previous confirmed COVID-19 infection<br>• Fever (>38 C) within the past 24 hours or suspicion of active viral or bacterial infection<br>• Vaccination with other live attenuated vaccine within the last 4 weeks<br>• Subjects who do not have access to e-Boks<br>• Severely immunocompromised subjects. This exclusion category comprises:<br>• Subjects with known infection with human immunodeficiency virus (HIV)<br>• Subjects with solid organ transplantation or bone marrow transplantation<br>• Subjects under chemotherapy<br>• Subjects with primary immunodeficiency<br>• Treatment with any anti-cytokine therapy within the last year<br>• Treatment with oral or intravenous steroids defined as daily doses of 10 mg prednisone or equivalent for longer than 3 months<br>• Active solid or non-solid malignancy or lymphoma within the prior two years<br> | Healthy volunteers, senior citizens of 65 years or older.
Immune system activation after BCG vaccination. Acute infections, COVID-19 and self-reported respiratory illness will be monitored. <br>MedDRA version: 23.0
Level: LLT
Classification code 10084382
Term: Coronavirus disease 2019
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: BCG Vaccine 'AJ Vaccines'<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Bacillus Calmette-Guerin<br>Other descriptive name: BACILLUS CALMETTE-GUERIN VACCINE<br>Concentration unit: CFU/ml colony forming unit(s)/millilitre<br>Concentration type: range<br>Concentration number: 2 x 10_5 -8 x 10_5<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intradermal use<br><br> | Main Objective: Primary objective: To reduce senior citizens’ risk of acute infection during the COVID-19 pandemic. ;Timepoint(s) of evaluation of this end point: End of trial.;Primary end point(s): The primary outcome is acute infection identified either by a doctor, antibiotics use, hospitalization or death due to infection. <br>;Secondary Objective: Secondary objectives: To reduce senior citizens’ risk of SARS-CoV-2 infection during the COVID-19 pandemic. To reduce senior citizens’ risk of self-reported respiratory illness during the COVID-19 pandemic.→Timepoint(s) of evaluation of this end point: End of trial.;Primary end point(s): The primary outcome is acute infection identified either by a doctor, antibiotics use, hospitalization or death due to infection. <br>;Secondary Objective: Secondary objectives: To reduce senior citizens’ risk of SARS-CoV-2 infection during the COVID-19 pandemic. To reduce senior citizens’ risk of self-reported respiratory illness during the COVID-19 pandemic.;Main Objective: Primary objective: To reduce senior citizens’ risk of acute infection during the COVID-19 pandemic. | | | | Yes | False | | |
| EUCTR2021-001279-18-Outside-EU/EEA | 17 March 2021 | Embedded RCT Short Title: Smartphone app-based mental health and wellbeing intervention for healthcare workers during Covid-19. | Overall Study Name: NHS CHECK - Health & Experiences of staff working at NHS Trusts and Nightingale Hospitals.
Embedded RCT Full Title: Effectiveness of a smartphone app-based intervention in improving stress, resilience, wellbeing and mental health outcomes in a high-risk healthcare worker population during Covid-19: a randomised controlled parallel group trial. | | King’s College London | 09/03/2021 | 20210309 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-001279-18 | Not Available | No | | | <br>Female: yes<br>Male: yes<br> | | | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: yes<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Treatment as usual<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| United Kingdom | Research and Development | | James Clerk Maxwell Building, 57 Waterloo Road | Thomas.foulkes@kcl.ac.uk | +4402071886206 | King’s College London | Inclusion criteria: <br>1. Be aged 18 and over.<br>2. Be an NHS-affiliated member of staff, working at, or with, the participating eighteen NHS CHECK sites.<br>3. Completed baseline survey with NHS CHECK Cohort study and have consented to be contacted for further research as part of study. <br>4. Be able to give informed consent to take part in research.<br>5. Be able to understand and communicate in English.<br>6. Have access to the internet to complete the surveys.<br>7. Have access to an email address to facilitate application registration and receive survey links.<br>8. Own a smartphone with access to the Apple and Google Application Stores.<br><br>The following 18 NHS Trusts have been selected to include a mixture of urban and rural settings:<br><br>Avon and Wiltshire Mental Health Mental Health Partnership Trust <br>Cambridge University Hospitals NHS Foundation Trust<br>Cambridgeshire and Peterborough NHS Foundation Trust<br>Cornwall Partnership NHS Foundation Trust<br>Devon Partnership NHS Foundation Trust <br>East Suffolk and North Essex NHS Foundation Trust<br>Gloucestershire Hospitals NHS Foundation Trust<br>Guys and St Thomas' NHS Foundation Trust<br>King's College Hospital NHS Foundation Trust <br>Lancashire and South Cumbria NHS Foundation Trust <br>Norfolk and Norwich University Hospitals Foundation Trust<br>Nottinghamshire Healthcare NHS Foundation Trust<br>Royal Papworth Hospital NHS Foundation Trust <br>Sheffield Health and Social Care NHS Foundation Trust<br>South London and Maudsley NHS Foundation Trust <br>Tees Esk and Wear Valleys NHS Foundation Trust <br>University Hospitals of Derby and Burton NHS Foundation Trust<br>University Hospitals of Leicester NHS Foundation Trust <br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 650<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 50<br> | Exclusion criteria: <br>1. Plans to start new interventions after randomisation during eight week trial period (e.g. apps, psychological therapies and pharmacological therapies).<br> | Mental Health and Wellbeing of Healthcare Staff;Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03] | <br>Trade Name: Foundations App - Koa Health<br>Product Name: Foundations App<br>Product Code: N/A<br>Pharmaceutical Form: <br><br> | Timepoint(s) of evaluation of this end point: 4 and 8 weeks (alongside baseline);Primary end point(s): 1. The GHQ-12 is a 12-item scale which screens for general (non-psychotic) psychiatric morbidity, (Goldberg et al., 1992).;Secondary Objective: Not Applicable;Main Objective: To evaluate whether the use of Foundations mobile application impacts stress, wellbeing, anxiety, depression, functioning, resilience and sleep in a real-world, high-risk healthcare worker cohort. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04427566 | 22 March 2021 | Low Dose Whole Lung Radiation Therapy for Patients With COVID-19 and Respiratory Compromise | Vented COVID: A Phase II Study Of The Use Of Ultra Low-Dose Bilateral Whole Lung Radiation Therapy in the Treatment Of Critically Ill Patients With COVID-19 Respiratory Compromise | VENTED | Ohio State University Comprehensive Cancer Center | 05/06/2020 | 20200605 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04427566 | Recruiting | No | 18 Years | N/A | All | July 23, 2020 | 24 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | ; ; | Arnab Chakravarti;Arnab Chakravarti;Arnab Chakravarti, MD | | ;Arnab.Chakravarti@osumc.edu;Arnab.Chakravarti@osumc.edu | ;614-293-0672;614-293-8415 | James Cancer Hospital, Department of Radiation Oncology; |
<br> Inclusion Criteria:
<br>
<br> - Laboratory Diagnosis of COVID-19 based within 14 days of enrollment.
<br>
<br> - CT or radiographic findings typical of COVID-19 pneumonia within 5 days of enrollment
<br>
<br> - Receiving ICU-based mechanical ventilation
<br>
<br> - Life expectancy = 24 hours, as judged by investigator
<br>
<br> - Hypoxemia defined as a Pa/FIO2 ratio < 300 or SpO2/FiO2 < 315
<br>
<br> - Signed informed consent by patient or his or her legal/authorized representative
<br>
<br> Exclusion Criteria:
<br>
<br> - Moribund with survival expected < 24 hours, as judged by investigator and treating
<br> team
<br>
<br> - Expected survival < 30 days, as judged by investigator and treating team, due to
<br> chronic illness present prior to COVID infection
<br>
<br> - Patient or legal representative not committed to full disease specific therapy, i.e.
<br> comfort care (DNRCCA is allowed)
<br>
<br> - Treatment with immune suppressing medications in the last 30 days (steroids for acute
<br> respiratory distress syndrome or septic shock allowed)
<br>
<br> - Presumed COVID-associated illness greater than 14-days
<br>
<br> - Inpatient admission greater than 14-days
<br>
<br> - Patient deemed unsafe for travel for radiation therapy
<br>
<br> - Chronic hypoxemia requiring supplemental oxygen at baseline
<br>
<br> - Documented active connective tissue disease (scleroderma) or idiopathic pulmonary
<br> fibrosis
<br>
<br> - History of prior radiation therapy resulting in =grade 2 radiation pneumonitis within
<br> 365 days of enrollment
<br>
<br> - Active or history of prior radiation to the thorax completed within 180 days of
<br> enrollment (skin or surface only skin treatments are acceptable)
<br>
<br> - Known active uncontrolled bacterial or fungal infections of the lung.
<br>
<br> - Active cytotoxic chemotherapy
<br>
<br> - Females who are pregnant or have a positive pregnancy test
<br>
<br> - Breast feeding
<br>
<br> - Note: concurrent administration of convalescent immune plasma therapy either on
<br> clinical trial or as a standard therapy not an exclusion criterion, but will be noted
<br> | | COVID-19 | Radiation: Radiation therapy | Mortality rate of subjects treated with whole lung low-dose radiation | | | | Yes | False | | |
| → | NCT04432324 | 22 March 2021 | Study to Evaluate the Safety and Efficacy of High Dose IVIG in Hospitalized Participants With Coronavirus Disease (COVID-19) | A Multicenter, Randomized, Open-label Parallel Group Pilot Study to Evaluate Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Hospitalized Subjects With COVID-19 | | Instituto Grifols, S.A. | 12/06/2020 | 20200612 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04432324 | Not recruiting | No | 18 Years | N/A | All | June 2, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | Spain | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Hospitalized male or female subject = 18 years of age at time of Screening who is
<br> being treated for COVID-19.
<br>
<br> 2. Has laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by
<br> qualitative Polymerase Chain Reaction (PCR) (reverse transcriptase [RT]-PCR), or other
<br> commercial or public health assay (of any type) in any specimen during the current
<br> hospital admission prior to randomization.
<br>
<br> 3. COVID-19 illness (symptoms) of any duration with radiographic infiltrates by imaging
<br> (Chest X-Ray, Computed tomography (CT) scan, etc.).
<br>
<br> 4. PaO2/FIO2 ratio > 300 to = 450 mmHg (i.e., arterial oxygen in mmHg divided by fraction
<br> inspired oxygen concentration [e.g., 0.21 for room air])
<br>
<br> 5. Any one of the following related to COVID-19: i. Ferritin > 400 nanogram per
<br> milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) > 300 units per liter U/L, iii.
<br> D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 milligram per liter
<br> (mg/L).
<br>
<br> 6. Subject (or a legal representative or a nearest relative or a relative by marriage, as
<br> appropriate) provides oral informed consent prior to initiation of any study
<br> procedures.
<br>
<br> Exclusion criteria:
<br>
<br> 1. Subject requires invasive mechanical ventilation or ICU admission.
<br>
<br> 2. Clinical evidence of any significant acute or chronic disease that, in the opinion of
<br> the investigator may place the subject at undue medical risk.
<br>
<br> 3. The subject has had a known (documented) serious anaphylactic reaction to blood, any
<br> blood-derived or plasma product or commercial immunoglobulin.
<br>
<br> 4. Subject has known (documented) hereditary fructose intolerance (HFI).
<br>
<br> 5. A medical condition in which the infusion of additional fluid is contraindicated.
<br>
<br> 6. Shock that is unresponsive to fluid challenge and/or multiple vasopressors and
<br> accompanied by multiorgan failure considered by the Principal Investigator not able to
<br> be reversed.
<br>
<br> 7. Subject with known (documented) thrombotic complications to polyclonal IVIG therapy in
<br> the past.
<br>
<br> 8. Subject with current or prior (within the past 1 month) myocardial infarction, stroke,
<br> deep vein thrombosis, or thromboembolic event.
<br>
<br> 9. Subject with limitations of therapeutic effort (eg, 'do not resuscitate' status).
<br>
<br> 10. Female subject who are pregnant or of child-bearing potential with a positive test for
<br> pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at
<br> Screening/Baseline.
<br>
<br> 11. Subject participating in another interventional clinical trial with investigational
<br> medical product or device.
<br> | | COVID-19 | Biological: Intravenous Immune Globulin;Drug: Standard Medical Treatment | Percentage of Participants Who are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation;Percentage of Participants Dying or Requiring ICU Admission→Percentage of Participants Dying or Requiring ICU Admission;Percentage of Participants Who are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation | | | | Yes | False | | |
| NCT04432350 | 22 March 2021 | Assessment of Mortality Rates in COVID-19 Infected Populations Treated With Repurposed Medications | Assessment of Mortality Rates in SARS-CoV-2 Infected Populations Treated With Repurposed Medications | | Tabula Rasa HealthCare | 12/06/2020 | 20200612 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04432350 | Not recruiting | No | N/A | N/A | All | June 15, 2020 | 50000 | Observational | | | United States | | Veronique Michaud | | | | Tabula Rasa HealthCare |
<br> Inclusion Criteria:
<br>
<br> - Patients receiving services at a PrescribeWellness pharmacy;
<br>
<br> - Patients who received a COVID-19 positive test at a PrescribeWellness Pharmacy or
<br> other certified COVID-19 test centers since February 1, 2020;
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who received a COVID-19 negative test at a PrescribeWellness Pharmacy or
<br> other certified COVID-19 test centers since February 1, 2020;
<br>
<br> - Patients who received COVID-19 repurposed drugs without laboratory-confirmed test for
<br> COVID-19 disease;
<br>
<br> - Patients who were receiving COVID-19 repurposed drugs prior to February 1, 2020.
<br> | | COVID;Drug Effect;Drug Interaction;Risk Reduction | | The rate of mortality in patients with a confirmed (positive test result) COVID-19 infection observed by PrescribeWellness pharmacies will be determined.;The relationship between high-risk cardio-pulmonary and vascular comorbidities (e.g., hypertension, dyslipidemia, diabetes, and chronic lung diseases) and mortality with use of repurposed medications for the treatment of COVID-19 will be investigated.;The MRS™ will be calculated using drug claim data from confirmed COVID-19 patients and explore the predictive value of MRS™ for ADE, LQTS and all-cause of death. | | | | Yes | False | | |
| → | NCT04439825 | 22 March 2021 | Impact of Botox Treatment Into the Upper One Third of the Face an Area on Mood and Self -Appearance Satisfaction | Randomized Controlled Single Blind Cross Over Trial Evaluating the Impact of Botox Treatment Into the Upper One Third of the Face an Area on Mood and Self -Appearance Satisfaction in a Post Covid Period. | | DeNova Research | 18/06/2020 | 20200618 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04439825 | Not recruiting | No | 10 Years | 75 Years | All | July 20, 2020 | 45 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Participant). | Phase 1 | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Males and females between the ages of 18-75
<br>
<br> - Subjects will be non-naive Botox users with a glabellar wrinkle severity score of 2 or
<br> 3 who are at least 20 weeks from their last BOTOX Cosmetic treatment
<br>
<br> - Subjects that understand the purpose and aspects of the study, freely sign the consent
<br> and complete the required treatment and follow up visits.
<br>
<br> Exclusion Criteria:
<br>
<br> - Males and females below the age of 18
<br>
<br> - Subjects that received neuromodulator injections to the glabella region in the last 20
<br> weeks
<br>
<br> - Subjects who do not meet a 2-3 wrinkle severity score in the glabellar region
<br>
<br> - Subjects who have received other invasive or semi invasive cosmetic forehead or
<br> glabellar treatments
<br>
<br> - Subjects who have had a change in antidepressant or anti- anxiety medication in last 6
<br> weeks
<br>
<br> - Subjects with severe depression, bipolar disorder, pregnant,
<br>
<br> - Subjects who are pregnant, attempting to get pregnant, or breast feeding
<br>
<br> - Subjects with a known allergy or sensitivity to any component of the study
<br> ingredients.
<br>
<br> - Subjects that do not understand the purpose and aspects of the study, do not sign the
<br> consent and do not complete the required treatment and follow up visit will also be
<br> excluded.
<br> | | Mood | Drug: Botulinum Neurotoxin;Drug: Placebo | Happiness levels before treatment and after achieving an optimal cosmetic result as determined by the PI.;Self- perception of mood before treatment and after achieving an optimal cosmetic result as determined by the PI.→Self- perception of mood before treatment and after achieving an optimal cosmetic result as determined by the PI.;Happiness levels before treatment and after achieving an optimal cosmetic result as determined by the PI. | | | | Yes | False | | |
| NCT04453371 | 22 March 2021 | Impact of Tissue Plasminogen Activator (tPA) Treatment for an Atypical Acute Respiratory Distress Syndrome (COVID-19) | Tissue Plasminogen Activator (tPA) Treatment for an Atypical Acute Respiratory Distress Syndrome (Microvascular COVID-19 Lung Vessels Obstructive Thromboinflammatory Syndrome (MicroCLOTS): A Multicentral Randomized Trial (AtTAC-trial) | AtTAC | Negovsky Reanimatology Research Institute | 26/06/2020 | 20200626 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04453371 | Not recruiting | No | 18 Years | N/A | All | October 15, 2020 | 0 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider). | Phase 3 | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Severe pulmonary coronavirus disease 19 (COVID 19) with suspect for MicroCLOTS
<br> (microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome)
<br>
<br> 2. P/F ratio <200 mmHg> 70 mmHg
<br>
<br> 3. a.) Contrast CT scan positive for pulmonary thrombosis, OR b.) Contrast CT scan
<br> negative for pulmonary thrombosis:
<br>
<br> - D-Dimer > 10 mcg/mL, OR
<br>
<br> - 5 < D-dimer < 10 mcg/mL and C Reactive Protein (CRP) > 100 mg/dL
<br>
<br> Exclusion Criteria:
<br>
<br> - Age < 18
<br>
<br> - Pregnancy or breastfeeding
<br>
<br> - Known allergy to iodinated contrast dye
<br>
<br> - Severe vasoplegic shock: norepinephrine > 300 ng/kg*min
<br>
<br> - Glomerular Filtration rate < 30 ml/min
<br>
<br> - Active bleeding or absolute contraindication to anticoagulant therapy (Stroke
<br> (intracranial hemorrhage, hemorrhagic stroke), including a history of the last 6
<br> months.; cancer of the Central nervous system and other localities with an increased
<br> risk of bleeding, vascular aneurysm, traumatic open heart massage, obstetric delivery,
<br> General operations, severe uncontrolled hypertension, gastric ulcer and 12-duodenal
<br> ulcer (for 3 months. from the moment of exacerbation), arterial or venous
<br> malformations, liver failure, liver cirrhosis, portal hypertension, esophageal
<br> varicose veins, active hepatitis).
<br> | | Acute Respiratory Distress Syndrome | Drug: Tissue plasminogen activator;Drug: Ringer solution | P/F (PaO2/FiO2) change during the first 72hrs after the end of the procedure in adult patients with severe atypical ARDS caused by SARS-2-CoV. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04686721 | 22 March 2021 | Observational Study for the Evaluation of Tracheal Stenosis in COVID-19 Patients | A Retrospective and Prospective Observational, Multicentric, Case-control Clinical Study for the Evaluation of Tracheal Stenosis Among Patients With COVID-19 and Prolonged Intubation or Tracheostomy. | TS1 | Istituto Clinico Humanitas | 21/12/2020 | 20201221 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04686721 | Recruiting | No | 18 Years | N/A | All | December 20, 2020 | 200 | Observational [Patient Registry] | | | Italy | ; | Umberto Cariboni, MD;Cariboni | | umberto.cariboni@humanitas.it; | +393385700988; | |
<br> Inclusion Criteria:
<br>
<br> - prolonged intubation, defined as the permanence of naso or oro- tracheal tube for more
<br> than 7 days
<br>
<br> - tracheostomy, whether surgical or percutaneous
<br>
<br> - minimum of 2 months follow-up from hospital discharge
<br>
<br> - Positivity to SARS-CoV-2 infection confirmed using PCR on either nasal swab or
<br> bronchoalveolar lavage will be not an inclusion criterion; patients tested negative
<br> will be used as a control group
<br>
<br> Exclusion Criteria:
<br>
<br> - Pediatric patients (< 18 years of age)
<br>
<br> - Patients without a minimum of 2 months follow-up from hospital discharge
<br> | | Tracheal Stenosis | Diagnostic Test: Chest CT scan + baseline spirometry | Outcome of tracheal stenosis;Clinical course of tracheal stenosis;Clinical presentation of tracheal stenosis;Incidence of tracheal stenosis following either prolonged intubation or tracheostomy in COVID-19 patients | | | | Yes | False | | |
| → | NCT04710303 | 22 March 2021 | COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults | Phase 1b Open-Label Study of the Safety, Reactogenicity, and Immunogenicity of a Prophylactic COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral Platform in Healthy South African Adults (ProVIVA-SA-1) | | ImmunityBio, Inc. | 13/01/2021 | 20210113 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04710303 | Recruiting | No | 18 Years | 50 Years | All | March 2, 2021 | 35 | Interventional | Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | South Africa | ; | Amy Ward, MD;Amy Ward, MD | | amyward41@gmail.com;amyward41@gmail.com | 27829403456;+27 021 650 5252 | |
<br> Inclusion Criteria
<br>
<br> 1. Adults, age 18 - 50 years, inclusive, at time of first study vaccination.
<br>
<br> 2. Able to understand and provide a signed informed consent that fulfils the relevant
<br> Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
<br>
<br> 3. Agrees to the collection of biospecimens (e.g. nasopharyngeal [NP] swabs) and venous
<br> blood per protocol.
<br>
<br> 4. Ability to attend required study visits and return for adequate follow-up, as required
<br> by this protocol.
<br>
<br> 5. Body mass index (BMI) < 30.00 kg/m2
<br>
<br> 6. Temperature < 38.0°C on day of first study vaccination.
<br>
<br> 7. Good general health as shown by medical history, physical exam, and screening
<br> laboratory tests
<br>
<br> 8. Screen negative for Tuberculosis per local screening guidelines
<br>
<br> 9. Male participants should all be at low risk of HIV acquisition based on pre-specified,
<br> validated criteria(Laher 2014) i.e. answering YES to any of the following questions:
<br>
<br> 1. Are you sexually abstinent? 2. Are you in a mutually monogamous relationship with a
<br> known HIV-uninfected partner? 3. Have you had only one partner in the preceding 12 months
<br> who is believed to be HIV-uninfected and with whom condoms were used regularly?
<br>
<br> Laboratory Inclusion Values/ Results:
<br>
<br> 10. Alanine aminotransferase (ALT) <1.1 times the upper limit of normal 11. Serum
<br> Creatinine <80 umol/L in females and <106 umol/L in males 12. Haemoglobin >12.0g/dL in
<br> females and >13.5g/dL in males 13. Platelets >150 x 109/L in all participants 14. No
<br> serological evidence of chronic infection with Hepatitis B (hepatitis B surface antigen
<br> (HepBSAg) negative by a locally approved assay) done during the screening period 15. No
<br> serological evidence of chronic infection with Hepatitis C (hepatitis C antibody(anti-HCV)
<br> negative by a locally approved assay) done during the screening period 16. Negative for
<br> SARS-CoV-2 (qPCR test) on NP swab(or other appropriate respiratory specimen) within 3 days
<br> prior to the first study vaccination 17. No serological evidence of prior infection with
<br> SARS-CoV-2 (by a locally approved assay) done during the screening period 18. A negative
<br> serum or urine pregnancy test during screening and on the day of and prior to each dose
<br> must be documented before the vaccine is administered to a female participant.
<br>
<br> 19. Negative for HIV-1 and -2 on blood test(by either 2 rapid tests or an ELISA, both must
<br> be locally approved assays) done during the screening period.
<br>
<br> Reproductive Status:
<br>
<br> 20. Female participants of childbearing potential must agree to use effective contraception
<br> for sexual activity that may lead to pregnancy while on study until at least 30 days after
<br> the last dose of the study vaccine. Effective contraception for female participants
<br> includes:
<br>
<br> - Intrauterine device (IUD), or
<br>
<br> - Hormonal contraception (oral/ injectable/ implant/ transdermal etc.) Or; 21.
<br> Non-sterile male participants must agree to use a condom while on study until at least
<br> 30 days after the last dose of the study vaccine.
<br>
<br> Or; 22. Participant must not be of reproductive potential or sterile(as verified by medical
<br> records), such as:
<br>
<br> - Having been diagnosed with menopause(with no menses for 1 year)
<br>
<br> - Having undergone hysterectomy, bilateral oophorectomy or orchidectomy
<br>
<br> - Having undergone surgical sterilization (e.g., vasectomy, tubal ligation)
<br>
<br> Exclusion Criteria:
<br>
<br> 1. A history of illness compatible with COVID-19 disease since March 2020.
<br>
<br> 2. Serious adverse reaction to any vaccine, any unrelated medication or any component of
<br> the investigational vaccine, including a history of anaphylaxis and symptoms of a
<br> severe allergic reaction and history of allergies in the past.
<br>
<br> 3. Pregnant or breastfeeding women.
<br>
<br> 4. Live in a nursing home or long-term care facility.
<br>
<br> 5. Chronic lung disease or moderate to severe asthma.
<br>
<br> 6. Bone marrow or organ transplantation recipients.
<br>
<br> 7. Diabetes.
<br>
<br> 8. Chronic kidney disease undergoing dialysis.
<br>
<br> 9. Liver disease.
<br>
<br> 10. Any disease associated with acute fever, or any infection.
<br>
<br> 11. Self-reported history of severe acute respiratory syndrome (SARS).
<br>
<br> 12. Chronic hepatitis B or hepatitis C infection.
<br>
<br> 13. HIV positive or other acquired or hereditary immunodeficiency.
<br>
<br> 14. Serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial
<br> infarction, severe hypertension without controllable drugs, etc.
<br>
<br> 15. History of hereditary, idiopathic or acquired angioedema.
<br>
<br> 16. Urticaria in the last 12 months prior to screening.
<br>
<br> 17. No spleen or functional asplenia.
<br>
<br> 18. Platelet disorder or other bleeding disorder that may cause injection
<br> contraindication.
<br>
<br> 19. Chronic use (more than 14 continuous days) of any medications that may be associated
<br> with impaired immune responsiveness. (Including, but not limited to, systemic
<br> corticosteroids exceeding 10 mg/day of prednisone equivalent, allergy injections,
<br> immunoglobulin, interferon, immunomodulators. The use of low dose topical, ophthalmic,
<br> inhaled and intranasal steroid preparations will be permitted.)
<br>
<br> 20. Prior administration of blood products within 120 days before first study vaccination.
<br>
<br> 21. Prior administration of other research medicines or investigational product within 30
<br> days before first study vaccination.
<br>
<br> 22. Prior administration of attenuated vaccine within 30 days before first study
<br> vaccination..
<br>
<br> 23. Prior administration of inactivated vaccine within 14 days before first study
<br> vaccination.
<br>
<br> 24. Current treatment with investigational agents for prophylaxis of COVID-19.
<br>
<br> 25. Have a household contact that has been diagnosed with COVID-19 within 14 days before
<br> fist study vaccine.
<br>
<br> 26. Current anti-tuberculosis prophylaxis or therapy.
<br>
<br> 27. Currently receiving treatment for cancer or history of cancer in the last five years
<br> (except basal cell carcinoma of the skin and cervical carcinoma in situ).
<br>
<br> 28. According to the judgement of investigator any medical, psychiatric, psychological,
<br> social, occupational or other conditions that could affect the participants ability to
<br> sign informed consent, provide safety assessment data or comply with the requirements
<br> of the study protocol.
<br>
<br> 29. Assessed by the Investigator to be unable or unwilling to comply with the requirements
<br> of the protocol.
<br> | | Covid19 | Biological: hAd5-S-Fusion+N-ETSD vaccine | Incidence and severity of unsolicited AEs;Seroconversion rate of neutralizing antibody;GMT of neutralizing antibody;GMFR in neutralizing antibody;Percentage of participants who seroconverted;GMT of S-specific, RBD-specific, and N-specific antibodies;GMFR in IgG titer;Vital Sign - Respiratory Rate;Vital Sign - Blood Pressure;Vital Sign - Heart rate;Vital Sign - Temperature;Incidence of changes of laboratory safety examinations;Incidence of MAAEs and SAEs;Incidence and severity of unsolicited AEs;Incidence and severity of solicited systemic reactogenicity AEs;Incidence and severity of solicited local reactogenicity AEs;Incidence of MAAEs and SAEs→Incidence of changes of laboratory safety examinations;Vital Sign - Temperature;Vital Sign - Heart rate;Vital Sign - Blood Pressure;Vital Sign - Respiratory Rate;GMFR in IgG titer;GMT of S-specific, RBD-specific, and N-specific antibodies;Percentage of participants who seroconverted;GMFR in neutralizing antibody;GMT of neutralizing antibody;Seroconversion rate of neutralizing antibody;Incidence and severity of unsolicited AEs;Incidence of MAAEs and SAEs;Incidence and severity of unsolicited AEs;Incidence and severity of solicited systemic reactogenicity AEs;Incidence and severity of solicited local reactogenicity AEs;Incidence of MAAEs and SAEs | | | | Yes | False | | |
| NCT04713111 | 22 March 2021 | Stress and Recovery in Frontline COVID-19 Workers | Stress and Recovery in Frontline Healthcare COVID-19 Workers: A Feasibility Study Using Wearable and Smartphone Devices | | 4YouandMe | 08/01/2021 | 20210108 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04713111 | Not recruiting | No | 18 Years | N/A | All | May 4, 2020 | 383 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Screening. Masking: None (Open Label). | N/A | United States | | Stephen Friend, PhD, MD | | | | 4YouandMe |
<br> Inclusion Criteria:
<br>
<br> - Healthcare workers working directly with COVID-19 patients, or whose work routines
<br> have been shifted from COVID-19
<br>
<br> - Age over 18 years
<br>
<br> - Able to speak, write and read English, given the app will be available only in English
<br>
<br> - Able to provide informed consent
<br>
<br> - Have a personal IOS mobile phone (OS11 and above).
<br>
<br> - Own a personal wearable device including a Fitbit, Garmin, or Oura ring (BYOD arm
<br> only)
<br>
<br> Exclusion Criteria:
<br>
<br> - Prior COVID-19 infection
<br> | | Covid19;Stress;Wearables | Behavioral: Lifestyle (Meditation);Behavioral: Lifestyle (Exercise) | Garmin adherence;Oura adherence;Daily survey/task adherence;Study Retention | | | | No | False | | |
| → | NCT04732663 | 22 March 2021 | Understanding Exertional Dyspnea and Exercise Intolerance in COVID-19 | Understanding Exertional Dyspnea and Exercise Intolerance in COVID-19 | | University of Alberta | 28/01/2021 | 20210128 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04732663 | Recruiting | No | 18 Years | 70 Years | All | March 4, 2021 | 225 | Observational | | | Canada | ; ; | Michael K Stickland, Ph.D.;Michael K Stickland, Ph.D.;Desi Fuhr | | ;michael.stickland@ualberta.ca;fuhr@ualberta.ca | ;780-492-3995;780-492-1121 | University of Alberta; |
<br> Inclusion Criteria:
<br>
<br> - Covid-19/Symptom status as defined under each group.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Previous diagnosis of pulmonary hypertension
<br>
<br> 2. Obesity (body mass index >30 kg/m2)
<br>
<br> 3. Absolute contraindication to exercise testing or an orthopedic limitation that may
<br> interfere with cardiopulmonary exercise testing
<br> | | Covid19;Dyspnea | Other: No Intervention | Pulmonary Capillary Blood Volume (Vc);Peak Cardiac Output (Qpeak);Peak Oxygen Uptake (VO2peak)→Peak Oxygen Uptake (VO2peak);Peak Cardiac Output (Qpeak);Pulmonary Capillary Blood Volume (Vc) | | | | Yes | False | | |
| NCT04750720 | 22 March 2021 | Study of the Kinetics of COVID-19 Antibodies for 24 Months in Patients With Confirmed SARS-CoV-2 Infection | Study of the Kinetics of COVID-19 Antibodies for 24 Months in Patients With Confirmed SARS-CoV-2 Infection According to the Clinical Severity of the Infection. | ABCOVID | Centre Hospitalier Régional d'Orléans | 09/02/2021 | 20210209 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04750720 | Recruiting | No | 18 Years | N/A | All | August 27, 2020 | 300 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label). | N/A | France | ; ; | Thierry PRAZUCK, MD;Aurélie DESPUJOLS;Thierry PRAZUCK, MD | | ;aurelie.despujols@chr-orleans.fr;thierry.prazuck@chr-orleans.fr | ;+33238744071; | CHR ORLEANS; |
<br> Inclusion Criteria:
<br>
<br> - Age > 18
<br>
<br> - Having had a confirmed infection with CoV-2-SARS by RT-PCR and/or serology (IgM and/or
<br> IgG specific as significant)
<br>
<br> - Being vaccinated against anti-SARS-CoV-2 (vaccine sub-study)
<br>
<br> - Benefiting from a Social Security system
<br>
<br> - Having consented to participate in the study
<br>
<br> - Accepting regular follow-up for 24 months
<br>
<br> Exclusion Criteria:
<br>
<br> - Protected person (under guardianship or trusteeship)
<br>
<br> - Person under the protection of justice
<br>
<br> - Person unable to express consent
<br> | | Covid19;SARS-CoV-2 | Other: Sampling by venipuncture (and eventually by nasopharyngeal swab) | Presence of specific anti-SARS-CoV-2 antibodies;Presence of specific anti-SARS-CoV-2 antibodies;Presence of specific anti-SARS-CoV-2 antibodies;Presence of specific anti-SARS-CoV-2 antibodies;Presence of specific anti-SARS-CoV-2 antibodies;Presence of specific anti-SARS-CoV-2 antibodies;Presence of specific anti-SARS-CoV-2 antibodies;Presence of specific anti-SARS-CoV-2 antibodies | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04794374 | 22 March 2021 | Effects of Telerehabilitation After Discharge in COVID-19 Survivors | Effects of Telerehabilitation After Discharge on Quality of Life, Psychosocial Status, Physical Activity, Daily Activities of Living, and Sleep Quality in Patients Treated as Inpatients With the Diagnosis of COVID-19 | | Hacettepe University | 09/03/2021 | 20210309 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04794374 | Recruiting | No | 18 Years | 90 Years | All | November 16, 2020 | 30 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Turkey | ; ; ; ; ; ; ; ; ; ; ; | Lale Ozisik, Assoc.Prof.;Nursel Calik Basaran, Asst.Prof;Oguz Abdullah Uyaroglu, Asst.Prof;Deniz Inal-Ince, Prof.;Naciye Vardar-Yagli, Assoc.Prof.;Melda Saglam, Assoc.Prof.;Ebru Calik-Kutukcu, Assoc.Prof.;Esra Kinaci, MSc, PT.;Gulay Sain Guven, Prof.;Aslihan Cakmak, MSc, PT.;Aslihan Cakmak, MSc, PT;Aslihan Cakmak, MSc | | ;;;;;;;;;;aslihancakmak90@gmail.com;aslihancakmak90@gmail.com | ;;;;;;;;;;903123051576; | Hacettepe University;Hacettepe University;Hacettepe University;Hacettepe University;Hacettepe University;Hacettepe University;Hacettepe University;Hacettepe University;Hacettepe University;Hacettepe University; |
<br> Inclusion Criteria:
<br>
<br> - Being clinically stable,
<br>
<br> - Being 18 years old or older
<br>
<br> - Being a volunteer for the study and providing their consent,
<br>
<br> - Able to read and write
<br>
<br> - Having a smart phone and being able to use it
<br>
<br> Exclusion Criteria:
<br>
<br> - Having unstable clinical condition
<br>
<br> - Having severe neuromuscular and musculoskeletal problems,
<br>
<br> - Being unable to cooperate and respond to the questionnaires and scales
<br>
<br> - Not being a volunteer to participate
<br> | | Covid19 | Other: Telerehabilitation | Physical activity level;Psychosocial status;Sleep quality;Health related quality of life;Activities of daily living | | | | No | False | | |
| → | NCT04794803 | 22 March 2021 | Reparixin in COVID-19 Pneumonia - Efficacy and Safety | Study on the Efficacy and Safety of Reparixin in the Treatment of Hospitalized Patients With COVID-19 Pneumonia | | Dompé Farmaceutici S.p.A | 08/03/2021 | 20210308 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04794803 | Not recruiting | No | 18 Years | 90 Years | All | May 5, 2020 | 55 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2/Phase 3 | Brazil;Italy;Brazil;Italy→Italy;Brazil;Italy;Brazil | ; | Lorenzo Piemonti, MD PhD;Alberto Zangrillo, MD PhD | | ; | ; | Ospedale San Raffaele;Ospedale San Raffaele |
<br> Inclusion Criteria:
<br>
<br> - Phase 2 Inclusion Criteria:
<br>
<br> 1. Age 18 to 90.
<br>
<br> 2. Confirmed COVID-19 diagnosis
<br>
<br> 3. At least one of the following: # Respiratory distress, RR = 30 breaths/min
<br> without oxygen; # Partial arterial oxygen pressure (PaO2) / Fraction of
<br> inspiration O2 (FiO2) >100 <300mmHg
<br>
<br> (1mmHg = 0.133kPa). 4. Chest imaging confirms lung involvement and inflammation. 5.
<br> Inflammatory status as documented by at least one of the following: Lactate
<br> dehydrogenase (LDH) > normal range, C-reactive protein (CRP) = 100mg/L or IL-6 =
<br> 40pg/mL, serum ferritin = 900ng/mL, XDP >20mcg/mL.
<br>
<br> - Phase 3 Inclusion Criteria: Same as above; other criteria TBD based on Phase 2
<br> outcomes.
<br>
<br> Exclusion Criteria:
<br>
<br> • Phase 2/3 Exclusion Criteria:
<br>
<br> 1. Cannot obtain informed consent.
<br>
<br> 2. Severe hepatic dysfunction (Child Pugh score = C, or AST> 5 times the upper limit);
<br> Severe renal dysfunction (estimated glomerular filtration rate = 30mL / min / 1.73 m2)
<br> or receive continuous renal replacement therapy, hemodialysis, or peritoneal dialysis.
<br>
<br> 3. Patients with hypersensitivity to ibuprofen or to more than one non steroidal
<br> anti-inflammatory drug or to more than one medication belonging to the class of
<br> sulfonamides (e.g. sulfamethazine, sulfamethoxazole, sulfasalazine, nimesulide or
<br> celecoxib; hypersensitivity to sulphanilamide antibiotics alone, e.g.
<br> sulfamethoxazole, does not qualify for exclusion)
<br>
<br> 4. Severe, active bleeding such as hemoptysis, gastrointestinal bleeding, central nervous
<br> system bleeding, and nosebleeds within 1 month before enrollment.
<br>
<br> 5. Pregnant and lactating women and those planning to get pregnant.
<br>
<br> 6. Participated in other interventional clinical trials with investigational medicinal
<br> products, not considered suitable for this study by the researchers.
<br>
<br> 7. At the time of enrollment, patients not in a clinical condition compatible with the
<br> oral administration of the study drug.
<br> | | Severe Pneumonia | Drug: Reparixin;Drug: Standard of care | Phase 3 Primary Endpoint: Composite endpoint of death and of severe clinical events;Phase 3 Primary Endpoint: Composite endpoint of death and of severe clinical events;Phase 3 Primary Endpoint: Composite endpoint of death and of severe clinical events;Phase 3 Primary Endpoint: Composite endpoint of death and of severe clinical events;Phase 3 Primary Endpoint: Composite endpoint of death and of severe clinical events;Phase 3 Primary Endpoint: Composite endpoint of death and of severe clinical events;Phase 2 primary endpoint - Composite endpoint of clinical events;Phase 2 primary endpoint - Composite endpoint of clinical events;Phase 2 primary endpoint - Composite endpoint of clinical events;Phase 2 primary endpoint - Composite endpoint of clinical events;Phase 2 primary endpoint - Composite endpoint of clinical events;Phase 2 primary endpoint - Composite endpoint of clinical events | | | | No | False | | |
| NCT04796064 | 22 March 2021 | Low Versus High-Intensity Aerobic Training in Community-dwelling Older Men With Post-COVID 19 (SARS-CoV-2) Sarcopenia | Comparative Effectiveness Study of Low Versus High-Intensity Aerobic Training in Community-dwelling Older Men With Post-COVID 19 Sarcopenia | | Cairo University | 10/03/2021 | 20210310 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04796064 | Not recruiting | No | 60 Years | 80 Years | Male | March 30, 2020 | 76 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | N/A | Egypt | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Age range of 60 - 80 years with
<br>
<br> - A positive diagnosis of post-COVID-19 sarcopenia
<br>
<br> Exclusion Criteria:
<br>
<br> - Under medication
<br>
<br> - History of lower limb surgeries, fractures
<br>
<br> - Cardiac problems
<br>
<br> - Respiratory problems
<br>
<br> - Neurological problems
<br>
<br> - Systemic problems and any other contraindications for aerobic training
<br> | | Sarcopenia | Other: low-intensity aerobic training | Handgrip strength | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04799132 | 22 March 2021 | Association Between Body Mass Index and HFNC Therapy Success | Association Between Body Mass Index and High-flow Cannula Therapy Success in Patients With Severe Covid 19 Related Pneumonia. Retrospective Study. | | Clínica del country | 09/03/2021 | 20210309 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04799132 | Not recruiting | No | 18 Years | N/A | All | March 11, 2020 | 303 | Observational | | | Colombia | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Patients over 18 years of age.
<br>
<br> 2. Diagnosis of severe pneumonia secondary to COVID-19 infection and acute respiratory
<br> distress syndrome, defined by upper and lower respiratory symptoms plus positive
<br> C-reactive protein test for COVID-19.
<br>
<br> 3. Patient admission to the Clinical del Country and Clinica de la Colina intermediate
<br> care units.
<br>
<br> 4. Oxygen therapy by high-flow system (high-flow cannula) requirement.
<br>
<br> 5. Anthropometric data availability upon admission to our facilities.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients with a survival expectancy of less than 12 months according to the Charlson
<br> scale categorization or patients with oncological pathology.
<br>
<br> 2. Patients under 18 years of age.
<br>
<br> 3. Pregnant women.
<br>
<br> 4. Patients with cardiogenic pulmonary edema.
<br>
<br> 5. History of chronic liver disease or cirrhosis Child - Pugh C.
<br>
<br> 6. Patients with contraindications to high-flow cannula therapy initiation.
<br>
<br> 7. Patients with respiratory, hemodynamic and neurological indications that
<br> contraindicate HFNC initiation.
<br> | | Covid19;Obesity;Overweight;Pneumonia, Viral | | Primary outcome | | | | No | False | | |
| → | NCT04799444 | 22 March 2021 | LATE-COVID/LATE-COVID-Kids - Observational Study in Children and Adults | Complications Post COVID-19 - Observational Study in Children and Adults | LATE-COVID | Polish Mother Memorial Hospital Research Institute | 14/03/2021 | 20210314 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04799444 | Recruiting | No | N/A | N/A | All | October 1, 2020 | 500 | Observational [Patient Registry] | | | Poland | | Maciej Banach, MD,PhD,FNLA,FAHA,FESC,FASA | | maciej.banach@icloud.com | +48 42 2711124 | |
<br> Inclusion Criteria:
<br>
<br> - consecutive COVID-19 convalescents (the infection of coronavirus was confirmed with
<br> real-time polymerase chain reaction test or positive result of autoantibodies)
<br> admitted to the Departments of Polish Mother Memorial Research Institute (PMMHRI) in
<br> Lodz, Poland, for complications
<br>
<br> Exclusion Criteria:
<br>
<br> - no history of COVID-19 infection,
<br>
<br> - lack of complications post COVID-19,
<br>
<br> - severe course of Sars-COV-2 infection,
<br>
<br> - lack pf patient's agreement to be included in the study
<br> | | Covid19 | | Number of participants with severe post-COVID-19 complications;Factors related to the severity of post-COVID-19 complications→Factors related to the severity of post-COVID-19 complications;Number of participants with severe post-COVID-19 complications | | | | No | False | | |
| NCT04799704 | 22 March 2021 | Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic Patients. | Tear Film SARS-nCoV-2 Detection in Symptomatic and Pauci-symptomatic | Eye-Covid | Universitaire Ziekenhuizen Leuven | 11/03/2021 | 20210311 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04799704 | Not recruiting | No | 18 Years | N/A | All | September 11, 2020 | 30 | Observational | | | Belgium | | Delbeke Heleen, MD | | | | UZ Leuven |
<br> Inclusion Criteria:
<br>
<br> - Subject needs to be above 18 years old.
<br>
<br> - The subject is willing to undergo sampling of the conjunctiva.
<br>
<br> - The subject is willing to fill in a questionnaire.
<br>
<br> - The subject is fluent in written and verbal Dutch.
<br>
<br> - The subject is capable of giving informed consent.
<br>
<br> - Applicable for part 1 only: the subject test positive for SARS-nCoV-2 on a
<br> nasopharyngeal swab. The time window between a positive nasopharyngeal swab and the
<br> first conjunctival swab may be no more than 3 days.
<br>
<br> Exclusion Criteria:
<br>
<br> - Allergy to Oxybuprocainehydrochloride
<br>
<br> - Pregnancy or lactation
<br> | | Covid19;Eye Diseases | Diagnostic Test: swabbing of conjunctiva | Correlations between SARS-nCoV-2 in the tear film;The presence of SARS-nCoV-2 in the tear film of symptomatic and pauci-symptomatic SARS-nCoV-2 positive patients. | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-005961-16-DK | 22 March 2021 | Coenzym Q10 til behandling af senfølger efter COVID-19 (QVID studiet) | Coenzyme Q10 as treatment for Long Term COVID-19
(The QVID study)
- QVID study | | Lars Jørgen Østergaard | 15/12/2020 | 20201215 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005961-16 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 05/02/2021 | 120 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: yes<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Denmark | Department of Infectious Diseases | | Palle Juul-Jensens Boulevard 99 | KRTHAS@rm.dk | 004578452800 | Aarhus University Hospital | Inclusion criteria: <br>1. Age above 18 years.<br>2. Able to give informed consent.<br>3. History of documented SARS-CoV-2 infection either by RT-PCR or antibody test.<br>4. Symptoms related to LTC, defined as being investigated, diagnosed and followed by specialized infectious diseases physicians in the Long Term COVID-19 Outpatient Clinic, Central Region of Denmark, Aarhus University Hospital. This clinic covers all LTC patients referred from general practitioners and regional hospitals in Region Midtjylland.<br>5. Symptoms not attributable to other co-morbidity/condition. <br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 110<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 10<br> | Exclusion criteria: <br>1. Symptoms of acute COVID-19, as defined by The Danish Health Authorities/Sundhedsstyrelsen.<br>2. Pregnant or breast-feeding women.<br>3. Known allergy to soy or peanuts.<br>4. Individuals with reduced kidney or liver-function.<br>5. Patients in anticoagulant therapy with warfarin or similar vitamin K antagonists.<br>6. Any condition that, in the Investigator's opinion, will prevent adequate compliance with study therapy.<br><br><br> | Long Term COVID-19 illness <br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Body processes [G] - Cell Physiological Phenomena [G04] | <br>Trade Name: Myoquinon 100 mg<br>Pharmaceutical Form: Capsule, soft<br>INN or Proposed INN: UBIDECARENONE<br>CAS Number: 303-98-0<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 100-<br>Pharmaceutical form of the placebo: Capsule, soft<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: Evaluation of primary endpoint after 6 weeks treatment, 4 weeks washout and 6 weeks placebo (order of intervention determined by allocation by randomization);Primary end point(s): Number and severity of self-reported symptoms of LTC, measured by self-reporting in questionnaires before and after 6 weeks of CoQ10, measured by symptoms score.;Secondary Objective: Secondary objectives:<br>-To assess a potential persistent effect of CoQ10 after 6 weeks dosing and 4 weeks of follow-up on the number and severity of self-reported symptoms in LTC patients.<br>-To assess the safety and tolerability of the IMP<br><br>Potential exploratory objectives:<br>-To investigate occurrence of auto-reactive antibodies at baseline compared to healthy controls (biobank samples).<br>-To assess CoQ10 levels in plasma before and after CoQ10 treatment <br>-To investigate if certain host genetic factors predict LTC<br>-To perform quantitative proteomics of PBMCs by high mass accuracy nanoLC-MS/MS. <br>-To assess cellular metabolic activities by Seahorse analyses of PBMCs samples<br>-To assess oxidative stress in plasma through the marker 8-isoprostane (ELISA).<br>-To assess a panel of cytokines in plasma through antibody based multiplexed analyses.<br>-To assess metabolites of kynurenic pathway in plasma by UPLC-MS/MS.<br>;Main Objective: To assess the effect of 6 weeks of CoQ10 treatment on the number and severity of self-reported symptoms in LTC patients | | | | Yes | False | | |
| → | EUCTR2021-000710-42-NL | 22 March 2021 | Research into the effect of the COVID-vaccine in patients who are treated with rituximab (RTX-COVAC study) | The RTX-COVAC study: humoral response to COVID-19 vaccination after rituximab, and relation with dose and vaccination timing. A prospective cohort study. - RTX-COVAC | | Sint Maartenskliniek | 08/03/2021 | 20210308 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000710-42 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 15/03/2021 | 270 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Netherlands | Principal Investigator | | Hengstdal 3 | d.tencate@maartenskliniek.nl | | Sint Maartenskliniek | Inclusion criteria: <br>• Rheumatoid arthritis: either 2010 EULAR/ACR RA and/or 1987 ACR RA criteria and/or clinical diagnosis of the treating rheumatologist;<br>• Treatment with at least one dose of rituximab (most of the times 200 mg, 500 mg or 1000 mg one or two times, but all dosages are included) in the year prior to the COVID-19 vaccine;<br>• Expected to receive a registered COVID-19 vaccine or have received a registered COVID-19 vaccine in the last 6 months;<br>• =16 years old and mentally competent;<br>• Ability to read and communicate in Dutch.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 170<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 100<br> | Exclusion criteria: <br>• Not eligible (for example allergic to one of vaccine ingredients) or not willing to receive the COVID-19 vaccine;<br> | Rheumatoid arthritis <br>MedDRA version: 23.1
Level: PT
Classification code 10039073
Term: Rheumatoid arthritis
System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05] | <br>Trade Name: Comirnaty<br>Pharmaceutical Form: Concentrate for solution for injection<br><br>Trade Name: COVID-19 Vaccine Moderna<br>Product Name: COVID-19 Vaccine Moderna<br>Pharmaceutical Form: Dispersion for injection<br><br>Trade Name: COVID-19 Vaccine AstraZeneca<br>Product Name: COVID-19 Vaccine AstraZeneca<br>Pharmaceutical Form: Suspension for injection<br><br> | Timepoint(s) of evaluation of this end point: 2-4 weeks after last vaccine dose;Primary end point(s): Total immunoglobulin (IgT) titre against COVID-19;Secondary Objective: To perform a sensitivity analysis on the primary objective, using the antibody index number as continuous outcome measure; <br>To analyse the independent effect of various demographics, disease characteristics and comedication on the primary objective and on the humoral immunogenicity itself. <br>To investigate the humoral response over a longer period of time (2 weeks – 6 months) in patients with RA treated with RTX.;Main Objective: To investigate, in RA patients, the role of RTX dose and timing of the vaccination related to RTX administration on the humoral immunogenicity against COVID-19 vaccines, with response/non response against the vaccine as a dichotomous outcome measure.→Main Objective: To investigate, in RA patients, the role of RTX dose and timing of the vaccination related to RTX administration on the humoral immunogenicity against COVID-19 vaccines, with response/non response against the vaccine as a dichotomous outcome measure.;Secondary Objective: To perform a sensitivity analysis on the primary objective, using the antibody index number as continuous outcome measure; <br>To analyse the independent effect of various demographics, disease characteristics and comedication on the primary objective and on the humoral immunogenicity itself. <br>To investigate the humoral response over a longer period of time (2 weeks – 6 months) in patients with RA treated with RTX.;Primary end point(s): Total immunoglobulin (IgT) titre against COVID-19;Timepoint(s) of evaluation of this end point: 2-4 weeks after last vaccine dose | | | | Yes | False | | |
| EUCTR2021-000842-16-SE | 22 March 2021 | The effects of Perfluoroalkyl substances on SARS-CoV-2 vaccination. | Does PFAS-exposure modify the risk of COVID-19 infection or the immunological response after vaccination against SARS-CoV-2? | | Kristina Jakobsson | 18/02/2021 | 20210218 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000842-16 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 18/03/2021 | 500 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: <br>Double blind: <br>Parallel group: <br>Cross over: <br>Other: <br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Sweden | Kristina Jakobsson | | Medicinaregatan 16A | Kristina.jakobsson@amm.gu.se | +46031786 6256 | University of Gothenburg | Inclusion criteria: <br>Men and women, 20 to 60 years old, who participated in PFAS-studies 2014-2016 with measured serum PFAS-levels, planning to be vaccinated against SARS-CoV-2.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 500<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>Previous vaccination against SARS-CoV-2<br> | An observational study in healthy, differently PFAS-exposed subjects to check if PFAS modifies the immunological response to SARS-CoV-2 vaccination. The immunological response is quantified as SARS-CoV-2-specific IgG antibody production and T-cell activity. <br>MedDRA version: 23.0
Level: LLT
Classification code 10084462
Term: SARS-CoV-2 vaccination
System Organ Class: 100000004865
<br>MedDRA version: 23.1
Level: LLT
Classification code 10084465
Term: COVID-19 vaccination
System Organ Class: 100000004865
;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Pharmaceutical Form: Injection<br><br> | Timepoint(s) of evaluation of this end point: 1, 6 and 24 months after full vaccination.;Primary end point(s): IgG-antibodies against S-protein from SARS-CoV-2;Secondary Objective: Secondary research question: Does PFAS-exposure affects the cellular immune response after SARS-CoV-2-vaccination?<br><br>This question will be answered through analyses of SARS-CoV-2 specific T-cell response. Exposure to PFAS is quantified as the molar sum of the 16 PFAS-substances in serum, and stratified into low and high.<br>;Main Objective: The overarching aim is to gather knowledge about how Perfluoroalkyl substances (PFAS) affects the immune system. This aim is studied through immunological response after SARS-CoV-2-vaccination in adults. <br><br>Primary research question: Does PFAS-exposure modify IgG-antibody production after SARS-CoV-2-vaccination?<br><br>The question will be answered through quantification of IgG-antibodies against SARS-CoV-2 S-protein. Exposure to PFAS is quantified as the molar sum of the 16 PFAS-substances in serum, and stratified into low and high. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04348461 | 29 March 2021 | BAttLe Against COVID-19 Using MesenchYmal Stromal Cells | Two-treatment,Randomized, Controlled, Multicenter Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Expanded Allogeneic Adipose Tissue Adult Mesenchymal Stromal Cells in Critically Ill Patients COVID-19 | | Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz | 10/04/2020 | 20200410 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04348461 | Not recruiting | No | 18 Years | N/A | All | May 6, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | Spain | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Patients of both sexes.
<br>
<br> - Over 18 years.
<br>
<br> - Confirmation of SARS-COV-2 infection by RT-PCR in respiratory sample.
<br>
<br> - Respiratory failure requiring intubation and connection to mechanical ventilation,
<br> secondary to SARS-CoV-2 infection.
<br>
<br> - Criteria for acute respiratory distress: acute bilateral alveolar-interstitial
<br> infiltrate not compatible with left ventricular failure (demonstrated with ultrasound
<br> or hemodynamic parameters), sudden onset, and blood gas compromise with a PaO2 / FiO2
<br> ratio <200 mm-Hg.
<br>
<br> - Women of childbearing potential should have a negative urine pregnancy test performed
<br> at the time of study enrollment.
<br>
<br> - Written or verbal informed consent from the patient, family member or legal
<br> representative.
<br>
<br> Exclusion Criteria:
<br>
<br> - Any other cause of acute respiratory distress not attributable to SARS-Cov-2.
<br>
<br> - RT-PCR of SARS-Cov-2 negative.
<br>
<br> - Multi-organ failure (more than three organs)
<br>
<br> - Severe respiratory failure requiring extracorporeal support (ECMO) Grave Moderate
<br> severe COPD requiring chronic home oxygen therapy, need for prior home oxygen therapy
<br> for any reason.
<br>
<br> - Pregnancy, lactation and women of childbearing age but who do not take effective
<br> contraceptive measures.
<br>
<br> - Active tumor disease.
<br>
<br> - Previous immunosuppressive treatment.
<br>
<br> - Allergy or hypersensitivity to the administered products.
<br>
<br> - History of deep vein thrombosis or pulmonary embolism in the last 3 years.
<br>
<br> - Participation in other clinical trials during the 3 months prior to the initial visit.
<br> | | COVID;Respiratory Distress Syndrome | Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells | Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate;Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate) | | | | Yes | False | | |
| → | NCT04351711 | 29 March 2021 | Immunological Profiling of Patients With COVID-19 in Respiratory Distress | Immunological Profiling of Patients With COVID-19 in Respiratory Distress | ACTICOV-2 | Centre Hospitalier Universitaire de Nimes | 10/04/2020 | 20200410 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04351711 | Recruiting | No | 18 Years | N/A | All | April 9, 2020 | 130 | Observational | | | France | ; ; | Pierre Corbeau;Pierre Corbeau;Anissa Megzari | | ;pierre.corbeau@chu-nimes.fr;drc@chu-nimes.fr | ;06.07.23.16.35;04.66.68.42.36 | CHU Nimes; |
<br> Inclusion Criteria:
<br>
<br> - The patient must be a member or beneficiary of a health insurance plan
<br>
<br> - Patient hospitalized in respiratory resuscitation or in the service of Infectious and
<br> Tropical Diseases of the CHU de Nîmes with infection by SARS-CoV-2, confirmed by
<br> RT-PCR.
<br>
<br> Exclusion Criteria:
<br>
<br> - The subject is in a period of exclusion determined by a previous study
<br>
<br> - The patient is under safeguard of justice
<br>
<br> - Patient already under ventilation transferred from another center
<br> | | SARS-CoV-2;Covid-19 | Other: Immunological profiling;Other: Immunological profiling | Rate of circulating Granulocyte Macrophage Colony-Stimulating Factor compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating InterCellular Adhesion Molecule-1 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interferon alpha compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interferon beta compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interferon gamma compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-1 alpha compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-1 beta compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-4 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-6 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-8 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-10 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-12p70 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-13 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-17A compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating E-selectin (cluster of differentiation 62E) compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Soluble tumor necrosis factor alpha receptor type I compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Ultrasensitive C-Reactive Protein compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Soluble cluster of differentiation 163 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Soluble cluster of differentiation 14 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Immunoglobulin M compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Immunoglobulin G compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Immunoglobulin A compared to normal values (based on 150 healthy volunteers previously sampled);Number of regulatory T cells (CD4+CD25hiCD127loFoxP3+).;Membrane expression of cluster of differentiation 16 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 14 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 57 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 56 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 69 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of Human Leukocyte Antigen -DR isotype on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 28 on T CD4+ and T CD8+ cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 27 on T CD4+ and T CD8+ cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of CD57 on T CD4+ and T CD8+ cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 27 (naïve/central memory/effector memory) compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 45RA compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of Programmed cell death 1 protein compared to normal values (based on 150 healthy volunteers previously sampled);Percentage of regulatory T cells (CD4+CD25hiCD127loFoxP3+).;Membrane expression of cluster of differentiation 38 compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of Human Leukocyte Antigen -DR isotype compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Induced Protein 10 (C-X-C motif chemokine 10) compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Monocyte Chemoattractant Protein-1 (C-C Motif Chemokine Ligand 2) compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Macrophage inflammatory protein-1 alpha (C-C Motif Chemokine Ligand 3) compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Macrophage inflammatory protein-1 beta (C-C Motif Chemokine Ligand 4) compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating P-selectin compared to normal values (based on 150 healthy volunteers previously sampled);Rate of tumor necrosis factor alpha compared to normal values (based on 150 healthy volunteers previously sampled);Rate of tissue plasminogen activator compared to normal values (based on 150 healthy volunteers previously sampled);Rate of soluble form of endothelial protein C receptor compared to normal values (based on 150 healthy volunteers previously sampled);Rate of D-Dimers compared to normal values (based on 150 healthy volunteers previously sampled)→Rate of circulating Granulocyte Macrophage Colony-Stimulating Factor compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating InterCellular Adhesion Molecule-1 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interferon alpha compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interferon beta compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interferon gamma compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-1 alpha compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-1 beta compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-4 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-6 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-8 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-10 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-12p70 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-13 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Interleukin-17A compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating E-selectin (cluster of differentiation 62E) compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Soluble tumor necrosis factor alpha receptor type I compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Ultrasensitive C-Reactive Protein compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Soluble cluster of differentiation 163 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Soluble cluster of differentiation 14 compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Immunoglobulin M compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Immunoglobulin G compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Immunoglobulin A compared to normal values (based on 150 healthy volunteers previously sampled);Number of regulatory T cells (CD4+CD25hiCD127loFoxP3+).;Membrane expression of cluster of differentiation 16 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 14 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 57 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 56 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 69 on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of Human Leukocyte Antigen -DR isotype on Naturel Killer cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 28 on T CD4+ and T CD8+ cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 27 on T CD4+ and T CD8+ cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of CD57 on T CD4+ and T CD8+ cells compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 27 (naïve/central memory/effector memory) compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 45RA compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of Programmed cell death 1 protein compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of cluster of differentiation 38 compared to normal values (based on 150 healthy volunteers previously sampled);Membrane expression of Human Leukocyte Antigen -DR isotype compared to normal values (based on 150 healthy volunteers previously sampled);Percentage of regulatory T cells (CD4+CD25hiCD127loFoxP3+).;Rate of circulating Induced Protein 10 (C-X-C motif chemokine 10) compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Monocyte Chemoattractant Protein-1 (C-C Motif Chemokine Ligand 2) compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Macrophage inflammatory protein-1 alpha (C-C Motif Chemokine Ligand 3) compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating Macrophage inflammatory protein-1 beta (C-C Motif Chemokine Ligand 4) compared to normal values (based on 150 healthy volunteers previously sampled);Rate of circulating P-selectin compared to normal values (based on 150 healthy volunteers previously sampled);Rate of tumor necrosis factor alpha compared to normal values (based on 150 healthy volunteers previously sampled);Rate of tissue plasminogen activator compared to normal values (based on 150 healthy volunteers previously sampled);Rate of soluble form of endothelial protein C receptor compared to normal values (based on 150 healthy volunteers previously sampled);Rate of D-Dimers compared to normal values (based on 150 healthy volunteers previously sampled) | | | | Yes | False | | |
| NCT04363489 | 29 March 2021 | The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers) | The CEDiD Study (COVID-19 Early Diagnosis in Doctors and Healthcare Workers) | CEDiD | King's College London | 23/04/2020 | 20200423 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04363489 | Recruiting | No | 18 Years | N/A | All | August 20, 2020 | 60 | Observational | | | United Kingdom | ; ; ; ; ; ; | Alexander Zargaran, MBBS;Anne Greenough;Dina Radenkovic, MBBS;Rocio Martinez-Nunez, PhD;Kariem El-Boghdadly;Kariem El-Boghdadly, FRCA;Kariem El-Boghdadly | | ;;;;;kariem.elboghdadly@gstt.nhs.uk;kariem.elboghdadly@gstt.nhs.uk | ;;;;;020 7188 7188; | King's College London / Guy's and St Thomas' NHS Foundation Trust;King's College London;King's College London / Guy's and St Thomas' NHS Foundation Trust;King's College London;Guy's and St Thomas' NHS Foundation Trust; |
<br> Inclusion Criteria
<br>
<br> - Healthy healthcare professionals of any age
<br>
<br> Exclusion Criteria
<br>
<br> - Previous PCR/Antibody positive test for COVID-19
<br>
<br> - Not working in high-risk COVID-19 area (ICU, A&E, COVID positive wards)
<br>
<br> - Involved in COVID-19 Vaccine Trial
<br> | | Covid19 | Device: Wearable Medical Device (Empatica E4);Diagnostic Test: COVID-19 PCR Swab;Diagnostic Test: Pulse Oximeter | COVID-19 Infection | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-001498-63-BE | 5 April 2021 | Testing the Efficacy and Safety of BIO101, for the Prevention of Respiratory Deterioration, in Patients with COVID-19 Pneumonia (COVA study) | Adaptive design phase 2 to 3, randomized, double- blind, multicenter, to evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of BIO101 in the prevention of the respiratory deterioration in hospitalized patients with COVID-19 pneumonia (severe stage) | | Biophytis S.A. | 03/05/2020 | 20200503 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001498-63 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 18/05/2020 | 465 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>Other trial design description: placebo-controlled, group sequential and adaptive<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United Kingdom;Belgium;Brazil;United States;France | Mounia Chabane De Saint Aubin | | 14 Avenue de l' Opéra | mounia.chabane@biophytis.com | +33(0)144 27 23 87 | Biophytis S.A. | Inclusion criteria: <br>1. Age: 45 and older.
<br>2. Modified per Amendment 10:
<br>2.1 A confirmed diagnosis of COVID-19 infection, within the last 28 days, prior to randomization, as determined by PCR or other approved commercial or public health assay, in a specimen as specified by the test used.
<br>3. Hospitalized, in observation or planned to be hospitalized due to COVID-19 infection symptoms with anticipated hospitalization duration >=3 days
<br>a. Patients can be included even if treated with: oxygen
<br>supplementation, High-flow oxygen (HFO2), BiPAP and CPAP
<br>4. Modified per Amendment 10:
<br>4.1 With evidence of pneumonia based on all of the following:
<br>a. Clinical findings on a physical examination
<br>b. Respiratory symptoms developed within the past 14 days
<br>5. Modified per Amendment 10:
<br>5.1 With evidence of respiratory decompensation that started not more than 7 days before start of study medication and present at screening, meeting one of the following criteria, as assessed by healthcare staff:
<br>a. Tachypnea: =25 breaths per minute
<br>b. Arterial oxygen saturation =92%
<br>c. A special note should be made if there is suspicion of COVID-19-related myocarditis or pericarditis, as the presence of these is a stratification criterion
<br>6. Without a significant deterioration in liver function tests:
<br>a. ALT and AST = 5x upper limit of normal (ULN)
<br>b. Gamma-glutamyl transferase (GGT) = 5x ULN
<br>c. Total bilirubin = 5×ULN
<br>7. Willing to participate and able to sign an informed consent form (ICF).Or, when relevant, a legally authorized representative (LAR) might sign the ICF on behalf of the study participant
<br>8. Female participants should be:
<br>at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence of an alternative medical cause) or surgically sterile;
<br>OR
<br>a. Have a negative urine pregnancy test at screening
<br>b. Be willing to use a contraceptive method as outlined in inclusion criterion 9 from screening to 30 days after last dose.
<br>9. Male participants who are sexually active with a female partner must agree to the use of an effective method of birth control throughout the study and until 3 months after the last administration of investigational product;
<br>Note: medically acceptable methods of contraception that may be used by the participant and/or partner include combined oral contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine device, etonogestrel implant, each supplemented with a condom, as well as sterilization and vasectomy.
<br>10. Female participant who are lactating must agree not to breastfeed during the study and up to 14 days after the intervention.
<br>11. Male participants must agree not to donate sperm for the purpose of reproduction throughout the study and until 3 months after the last administration of investigational product;
<br>12. Inclusion criterion 12 removed per Amendment 10.
<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 100<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 100<br> | Exclusion criteria: <br>1. Not needing or not willing to remain in a healthcare facility during the entire study medication (i.e. while receiving study medication)
<br>2. Moribund condition (death likely in days) or not expected to survive for >7 days – due to other and non-COVID-19 related conditions
<br>3. Participant on invasive mechanical ventilation via an endotracheal tube, or extracorporeal membrane oxygenation (ECMO)
<br>4. Participant not able to take medications by mouth (as capsules or as a powder, mixed in water).
<br>5. Disallowed concomitant medication:
<br>a. Consumption of any herbal products containing 20 hydroxyecdysone and derived from Leuzea carthamoides; Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g. performance enhancing agents)
<br>6. Any known hypersensitivity to any of the ingredients, or excipients of the study medication, BIO101
<br>7. Exclusion criterion 7 removed per Amendment 10
<br>8. Exclusion Criterion 8 removed per Amendment 10<br> | Confirmed infection with SARS-CoV-2 (COVID-19) <br>MedDRA version: 20.0
Level: HLT
Classification code 10047465
Term: Viral infections NEC
System Organ Class: 10021881 - Infections and infestations
<br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: BIO101<br>Product Code: BIO101<br>Pharmaceutical Form: Capsule<br>INN or Proposed INN: NA<br>CAS Number: 5289-74-7<br>Current Sponsor code: BIO101<br>Other descriptive name: 20-hydroxyecdysone<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 175-<br>Pharmaceutical form of the placebo: Capsule<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: For end-of-part-1 interim analysis:<br>For safety analysis intended to facilitate recruitment for part 2, time frame – up to 28 days:<br><br>For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:<br><br>For part-2 sample size interim analysis:<br>For sample size re-assessment for part 2, time frame – up to 28 days:<br><br>For the final analysis:<br>Primary, time frame – up to 28 days: <br>;Primary end point(s): For end-of-part-1 interim analysis:<br><br>For safety analysis intended to facilitate recruitment for part 2, time frame – up to 28 days:<br><br>Safety and tolerability to BIO101:<br><br>• SUSARs, SAEs, AESIs, AEs<br>• Vital signs<br>• Safety labs (including testicular biomarkers)<br>• ECGs<br><br>For interim analysis intended to obtain indication of activity of BIO101, time frame – up to 28 days:<br><br>Primary:<br><br>• Proportion of participants with ‘negative’ events, of either of the following: <br>o All-cause mortality<br>o Respiratory failure, defined as any of the following:<br>- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)<br>- Requiring ECMO<br><br><br>Secondary:<br><br>• SpO2/FiO2<br>• Inflammatory markers including:<br>o IL 6<br>o TNFa <br>o D-dimer <br>• RAS / MAS biomarkers:<br>o Angiotensin 2<br>o Angiotensin 1-7 (Ang (1-7)<br>o Angiotensin 1-5 (Ang 1-5)<br>o Angiotensin 1<br>o Angiotensin-converting enzyme 2(ACE2) levels and activity<br><br>For part-2 sample size interim analysis:<br><br>For sample size re-assessment for part 2, time frame – up to 28 days:<br><br>• Proportion of participants with ‘negative’ events, of either of the following:<br>o All-cause mortality<br>o Respiratory failure, defined as any of the following: <br>- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)<br>- Requiring ECMO<br><br>For the final analysis:<br><br>Primary, time frame – up to 28 days: <br><br>• Proportion of participants with ‘negative’ events, of either of the following:<br>o All-cause mortality <br>o Respiratory failure, defined as any of the following: <br>- Requiring mechanical ventilation (including cases that will not be intubated due to resource restrictions and triage)<br>- Requiring ECMO<br>;Secondary Objective: Not applicable;Main Objective: Part 1<br>• Ascertain the safety and tolerability of BIO101, in order to facilitate recruitment to part 2<br>• Obtain preliminary indication of activity of BIO101, in preventing respiratory deterioration in the target population<br><br>Part 2<br>• Re-assess the sample size that is needed for the confirmatory part of the study<br>• Provide confirmation on the benefit of BIO101 in the target population<br>• Identify and assess potential biomarkers for further understanding of the effect of BIO101 in the target population<br> | | | | Yes | True | parent | |
| → | EUCTR2020-002772-12-FR | 5 April 2021 | Mesenchymal Stem Cell Therapy for SARS-CoV-2-related Acute Respiratory Distress Syndrome | Efficacy of infusions of mesenchymal stem cells from Wharton jelly in the moderate to severe SARS-Cov-2 related acute respiratory distress syndrome (COVID-19):
A Phase IIa double-blind randomized controlled trial - MSC-COVID19 | | CHRU NANCY | 03/06/2020 | 20200603 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002772-12 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 17/07/2020 | 30 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| France | Chef de projet | | CHRU de Nancy - Hôpitaux de Brabois - Rue du Morvan | dripromoteur@chru-nancy.fr | 003338315579 | Direction de la Recherche et de l'Innovation | Inclusion criteria: <br>1) Man or woman 18 years of age or older
<br>2) Patient with a biologically confirmed SARS-CoV-2 infection (by positive RT-PCR on a nasopharyngeal sample or any other sample)
<br>3) Patient with moderate to severe ARDS according to the BERLIN definition defined by a PaO2 / FiO2 ratio <200 and with endotracheal intubation and under invasive mechanical ventilation
<br>4) Patient hospitalized in the intensive care unit
<br>5) Provision of a written informed consent to participate to the study or for whom the consent of a family member or support person has been obtained (if the patient is unable to give consent) or inclusion in an immediate vital emergency if applicable
<br>6) Any woman of childbearing age with a negative Beta HCG test
<br>7) Personne affiliée à un régime de Sécurité Sociale ou bénéficiaire d’un tel régime<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 10<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 20<br> | Exclusion criteria: <br>1) Patient under invasive mechanical ventilation for more than 48 hours
<br>2)Patient with a chronic respiratory disease under oxygen therapy
<br>3) Patients with a history of Class III or IV pulmonary arterial hypertension (WHO classification)
<br>4) Patients under ECMO
<br>5) Immunosuppressive therapy (including corticosteroid therapy> 20 mg prednisolone)
<br>6) Active solid tumor or in remission for less than 2 years, malignant hematological disease, asplenia
<br>7) Patient who has received a hematopoietic stem transplantation or an organ transplant
<br>8) Therapeutic limitations like progression to expected death within 24 hours (according to the opinion of the medical team)
<br>9) Hypersensitivity to albumin or to any of the excipients (caprylic acid or sodium caprylate)
<br>10) Patient included in another ongoing interventional therapeutic trial with medicament
<br>11) Pregnant woman, parturient, nursing mother
<br>12) Minor (not emancipated)
<br>13) Person without liberty by judiciary or administrative decision
<br>14) Person undergoing psychiatric care under Articles L. 3212-1 and L. 3213-1 which do not fall under the provisions of Article L. 1121-8 (hospitalization without consent).
<br>15) Adult over 18 who are under a legal protection measure<br> | Moderate to severe SARS-Cov-2 related acute respiratory distress syndrome <br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01] | <br>Product Name: Mesenchymal Stem Cells (MSCs) from wharton jelly<br>Product Code: MSC-GW<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: X VIVO EXPANDED WHARTON'S JELLY DERIVED MESENCHYMAL STEM CELLS<br>Other descriptive name: EX VIVO EXPANDED WHARTON'S JELLY DERIVED MESENCHYMAL STEM CELLS<br>Concentration unit: Other<br>Concentration type: equal<br>Concentration number: 2000000-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intravenous use<br><br>Trade Name: VIALEBEX 40 mg/ml<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: ALBUMIN<br>CAS Number: 70024-90-7<br>Current Sponsor code: ALBUMIN<br>Other descriptive name: ALBUMIN<br>Concentration unit: g/l gram(s)/litre<br>Concentration type: equal<br>Concentration number: 40-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intravenous use<br><br>Trade Name: Chlorure de Sodium 0.9 %, solution pour perfusion<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: SODIUM CHLORIDE SOLUTION 0.9%<br>Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%<br>Concentration unit: % percent<br>Concentration type: equal<br>Concentration number: 0.9-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intravenous use<br><br>Trade Name: ACD formule A<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: CITRIC ACID MONOHYDRATE<br>Other descriptive name: CITRIC ACID MONOHYDRATE<br>Concentration unit: g/l gram(s)/litre<br>Concentration type: equal<br>Concentration number: 8-<br>INN or Proposed INN: TRISODIUM CITRATE DIHYDRATE<br>Other descriptive name: TRISODIUM CITRATE DIHYDRATE<br>Concentration unit: g/l gram(s)/litre<br>Concentration type: equal<br>Concentration number: 22-<br>INN or Proposed INN: GLUCOSE MONOHYDRATE<br>Other de | Main Objective: To investigate efficacy of WJ-MSCs, compared to a placebo, on respiratory function in patients with SARS-CoV-2 related moderate to severe ARDS.;Secondary Objective: 1) To assess the effect of WJ-MSC, compared to placebo, in patients with SARS-CoV-2 related moderate to severe ARDS, on duration of invasive mechanical ventilation during the hospital stay and maximum for 28 days<br>2) To assess the effect of WJ-MSC, compared to placebo, in patients with SARS-CoV-2 related moderate to severe ARDS, on the evolution of organ failures during the hospital stay and maximum for 28 days<br>3) o assess the effect of WJ-MSC, compared to placebo, in patients with SARS-CoV-2 related moderate to severe ARDS, on the duration of stay in intensive care unit, and the mortality during intensive care unit, during hospitalization, on D28 and D90.;Primary end point(s): The respiratory function is evaluated by the PaO2 / FiO2 ratio every day between D0 or D1 (before initiation of treatment with WJ-MSC or placebo) and D14.;Timepoint(s) of evaluation of this end point: D14→Timepoint(s) of evaluation of this end point: D14;Primary end point(s): The respiratory function is evaluated by the PaO2 / FiO2 ratio every day between D0 or D1 (before initiation of treatment with WJ-MSC or placebo) and D14.;Secondary Objective: 1) To assess the effect of WJ-MSC, compared to placebo, in patients with SARS-CoV-2 related moderate to severe ARDS, on duration of invasive mechanical ventilation during the hospital stay and maximum for 28 days<br>2) To assess the effect of WJ-MSC, compared to placebo, in patients with SARS-CoV-2 related moderate to severe ARDS, on the evolution of organ failures during the hospital stay and maximum for 28 days<br>3) o assess the effect of WJ-MSC, compared to placebo, in patients with SARS-CoV-2 related moderate to severe ARDS, on the duration of stay in intensive care unit, and the mortality during intensive care unit, during hospitalization, on D28 and D90.;Main Objective: To investigate efficacy of WJ-MSCs, compared to a placebo, on respiratory function in patients with SARS-CoV-2 related moderate to severe ARDS. | | | | Yes | True | parent | |
| EUCTR2020-001749-38-IT | 5 April 2021 | Visualization of inflammation in COVID-19 patients | PET/CT with 68Ga-IL2 for imaging IL2R+ cells in COVID-19+ patients
- 68Ga-IL2 imaging in COVID-19 | | Azienda Ospedaliero-Universitaria S. Andrea | 01/07/2020 | 20200701 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001749-38 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 02/10/2020 | 4 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>Other trial design description: There is no treatment. Is a diagnostic scan with a radiopharmaceutical to investigate lymphopenia<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Italy | Alberto Signore | | Via di grottarossa 1035 | alberto.signore@uniroma1.it | 00390633775538 | Azienda Ospedaliero-Universitaria S. Andrea | Inclusion criteria: <br>Age =18 years.<br>• Diagnosis of COVID-19 obtained by means of a swab performed at the University Hospital of Sant'Andrea.<br>• Interstitial pneumonia (unilateral / bilateral, moderate / severe) diagnosed by CT scan<br>• Laboratory exams at registration:<br>or WBC <4x103 / ul<br>o Lymphocytes <1500 / mm3<br>• Respiratory parameters:<br>o Respiratory acts =30 breaths / min<br>o SpO2= 93%<br>o PaO2 / FIO2 ratio =300<br>• Signature of informed consent.<br>• For women of childbearing age, negative pregnancy test before registration.<br>• Willingness to undergo studio imaging and blood sampling.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 2<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 2<br> | Exclusion criteria: <br>Age less than 18 years, pregnant women, absence of interstitial pneumonia<br> | Evaluation of the inflammatory infiltrate in patients with COVID-19 in order to map the "trafficking" of T-activated lymphocytes and clarify the causes of lymphopenia;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Radiolabelled interleukin 2<br>Product Code: 68Ga-IL2<br>Pharmaceutical Form: Solution for solution for injection<br><br> | Timepoint(s) of evaluation of this end point: 3 hour (one day examination);Primary end point(s): Evaluation of the inflammatory infiltrate in patients with COVID-19 in order to map the "trafficking" of T-activated lymphocytes and clarify the causes of lymphopenia;Secondary Objective: To verify if PET / CT with 68Ga-IL2 can be used to predict the prognosis of these patients and to select, more early and in a non-invasive way, those subjects candidates to receive invasive and targeted treatments.<br>Correlate the uptake of 68Ga-IL2 with the different subpopulations of T-activated lymphocytes;Main Objective: Evaluation of the inflammatory infiltrate in patients with COVID-19 in order to map the "trafficking" of T-activated lymphocytes and clarify the causes of lymphopenia | | | | Yes | False | | |
| EUCTR2020-001577-70-IT | 5 April 2021 | Clinical study on mesenchymal Cell Therapy for SARS-CoV-2 Pneumonia | Allogeneic Mesenchymal Stromal Cell (MSC) Therapy for SARS-CoV-2 Pneumonia: A Prospective Randomized Multicentre Phase I/IIa Open Label Study - RESCAT | | AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA | 21/10/2020 | 20201021 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001577-70 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 28/12/2020 | 60 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Standard of care<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Italy | Prof. Massimo Dominici | | Via del Pozzo, 71 | mdominici@unimore.it | 0594222858 | Azienda Ospedaliero-Universitaria Policlinico di Modena | Inclusion criteria: <br>Adult patients suffering from SARS-CoV-2 induced severe pneumonia admitted to semi-intensive or intensive COVID Units because of the need of ventilation support. <br>• Sign of the informed consent, <br>• Patients of either sex, aged 18-80 years (inclusive), <br>• Patient with a confirmed virological diagnosis of SARS-CoV2 infection by means of real-time Polymerase Chain Reaction, <br>• Hospitalization due to clinical and radiological diagnosis of pneumonia, <br>• PaO2/FiO2 value between 150-300 with impending necessity of noninvasive positive pressure respiratory support (nCPAP) or ventilator support through nasal pressure support ventilation (nPSV),<br>• Systolic artery pressure >90 mmHg without amine support, <br>• Modified Early Warning Score (MEWS) score <3, <br>• Absence of known active malignancy.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 20<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 40<br> | Exclusion criteria: <br>• Deny to informed consent, <br>• Known history of alcohol or drug abuse in the 12 months prior to inclusion, <br>• Presence of significant comorbidities, such as uncontrolled hypertension, invalidating psychiatric or neurological disorders, organ failure (renal impairment defined by creatinine clearance below 50 ml/min or by serum creatinine =2.0 mg/dl; hepatic impairment defined by total bilirubin =2.0 mg/dl and AST + ALT = 2.5 x upper normal value; cardiac failure with an output fraction =40%), or any other clinically significant condition, as determined by the Principal Investigator, <br>• Presence of chronic advanced cardio-pulmonary diseases, such as ILDs (obstructive pneumonia, severe pulmonary interstitial fibrosis, alveolar proteinosis, allergic alveolitis), <br>• Patient has a clinically relevant abnormality on electrocardiogram, as determined by the Principal Investigator, <br>• History of previous embolism, <br>• Known active malignancy, <br>• Patient with a history of severe allergic reactions (e.g., swelling of the mouth and throat, difficulty breathing, hypotension, or shock) requiring medical intervention, <br>• Patient with a positive test for human immunodeficiency virus or active hepatitis B or C disease or tuberculosis or further viral infections (influenza virus, adenovirus and other respiratory viruses), <br>• Patient is known to be pregnant, has a positive pregnancy test or is nursing, <br>• Patient has had major surgery, either open or laparoscopic, within the 3 months prior to screening, <br>• Previous haematopoietic stem cell or organ transplantation, <br>• Patient under immunosuppressive agents, <br>• Patients currently receiving, or having received within 2 months prior to enrolment into this clinical study, any other investigational drug.<br> | SARS-CoV-2 pneumonia <br>MedDRA version: 22.1
Level: LLT
Classification code 10061229
Term: Lung infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: cellule adipose perivascolari stromali mesenchimali<br>Product Code: [RR002]<br>Pharmaceutical Form: Suspension for injection<br>Current Sponsor code: RR002<br>Concentration unit: Other<br>Concentration type: range<br>Concentration number: 1000000-1500000<br><br>Product Name: cellule stromali mesenchimali da midollo osseo<br>Product Code: [CFM-1-BM-MSC]<br>Pharmaceutical Form: Suspension for injection<br>Current Sponsor code: CFM-1-BM-MSC<br>Concentration unit: Other<br>Concentration type: range<br>Concentration number: 1000000-1500000<br><br>Product Name: cellule stromali mesenchimali da sangue di cordone ombelicale<br>Product Code: [CF-CB-MSC]<br>Pharmaceutical Form: Suspension for injection<br>Current Sponsor code: CF-CB-MSC<br>Concentration unit: Other<br>Concentration type: range<br>Concentration number: 1000000-1500000<br><br>Product Name: cellule stromali mesenchimali da midollo osseo<br>Product Code: [PTC-MSC-TP]<br>Pharmaceutical Form: Suspension for injection<br>Current Sponsor code: PTC-MSC-TP<br>Concentration unit: Other<br>Concentration type: range<br>Concentration number: 1000000-1500000<br><br>Product Name: cellule stromali mesenchimali da cordone ombelicale<br>Product Code: [UC-MSC]<br>Pharmaceutical Form: Suspension for injection<br>Current Sponsor code: UC-MSC<br>Concentration unit: Other<br>Concentration type: range<br>Concentration number: 1000000-1500000<br><br> | Timepoint(s) of evaluation of this end point: End points will be assessed at 4 hours, 48 ¿¿hours, 7, 14, 28 and 180 days from the end of treatment or enrollment, as appropriate;Primary end point(s): The feasibility will be assessed through the evaluation of the production capacity of each Cell Factory participating in the study in terms of an adequate amount of cellular product lots sufficient to treat 100% of the patients recruited. In addition, the process of transfer of the cellular product to the Clinical Unit will be validated, so that all the quality, safety and therapeutic properties will be guaranteed, with particular reference to its viability. Finally, a protocol for the bedside preparation of the final suspension for administration will be implemented according to the Good Clinical Practice. <br>The safety will be assessed by recording all adverse events as coded by the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, based on their duration, intensity, and possible association with the treatment under study. More in depth, the absolute number/percentage of Suspected Unexpected Sever Adverse Reactions (SUSARs) and Severe Adverse Reactions (SARs) recorded after 2 and 4 weeks from the MSC treatment that will not exceed 10% will be considered the cutoff to be met.;Secondary Objective: Evaluation of the efficacy of MSC in terms of:<br>mortality rate <br>trend of the daily PaO2/FiO2 ratio<br>evaluation of the days to intubation<br>date of independence from non-invasive mechanical ventilation<br>date of independence from oxygen therapy<br>hospitalization lenght<br>radiological pattern response<br><br>Evaluation of: neutrophil, lymphocyte and platelet counts, platelet mean volume, C-reactive protein, ferritin, procalcitonin, LDH, fibrinogen, and D-dimer. <br><br>Comparative immunological study of the cytokine pattern and the immunophenotyphic cell profile of bronchoalveolar lavage fluid and peripheral blood samples will be carried out in order to establish the pathogenic mechanisms of COVID-19 tissue injury and the mechanism of action of MSC in this specific clinical setting.<br><br>Establish which IMP used, as stratified according to the tissue origin, is associated with the best result in terms of safety and efficacy.;Main Objective: Evaluation of the feasibility and safety of the use of allogeneic Mesenchymal stromal cells (MSC) to treat SARS-CoV-2 related severe pneumonia through the capability to treat all enrolled patients and monitoring the rate of adverse events | | | | Yes | False | | |
| → | EUCTR2020-003614-13-IT | 5 April 2021 | Study with hzVSF-v13 in patients with COVID-19 pneumonia: a phase II, proof of concept, multicentre, randomized, parallel-group, double-blind, placebo-controlled study | Efficacy and safety of intravenously administered hzVSF-v13 in patients with COVID-19 pneumonia: a phase II, proof of concept, multicentre, randomized, parallel-group, double-blind, placebo-controlled study - - | | ImmuneMed Inc. | 23/11/2020 | 20201123 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-003614-13 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 18/12/2020 | 105 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 3<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Italy;Russian Federation | Dipartimento Medico | | Palazzo Aliprandi - Via Matteotti, 10 | info.studiclinici@opis.it | 0362633633 | OPIS s.r.l. | Inclusion criteria: <br>1. Signed written informed consent from any patient capable of giving consent, or, when the patient is incapable of doing so, by his or her legal/authorized representative. Note: In accordance with the European Medicines Agency (EMA) “Guidance on the management of clinical trials during the covid-19 (coronavirus) pandemic version 3 28/04/2020”, if written consent by the trial participant is not possible (for example because of physical isolation due to COVID-19 infection), consent may be given orally by the trial participant in the presence of an impartial witness.<br>2. Age 18 years or older.<br>3. Patient is currently hospitalized.<br>4. Diagnosis of COVID-19 pneumonia including a positive RT-PCR test for SARS-CoV-2 of any specimen and lung involvement confirmed with chest imaging (X-ray or computed tomography [CT] scan).<br>5. Able to comply with the study protocol.<br>6. Female patients must be postmenopausal (24 months of amenorrhea), surgically sterile or must agree to use an effective method of contraception throughout the study and for up to 120 days after stopping treatment. Effective contraception includes an established hormonal therapy or intrauterine device for females, and the use of a barrier contraceptive (i.e. diaphragm or condoms) with spermicide.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 11<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 23<br> | Exclusion criteria: <br>1. Patients with known or suspected hypersensitivity to hzVSF-v13 or to any of its excipients.<br>2. Active tuberculosis or suspected active bacterial, fungal, viral, or other infection (besides COVID-19).<br>3. Anti-rejection or immunomodulatory drugs within the past 3 months.<br>4. Absolute neutrophil count (ANC) < 1000/µL at screening.<br>5. Platelet count < 50,000/ µL at screening.<br>6. ALT or AST > 5 x upper limit of normal (ULN) within 24 hours at screening.<br>7. Serum creatinine > 2 mg/dL (> 176.8 µmol/L) or estimated creatinine clearance < 30 ml/min measured or calculated by Cockroft Gault equation.<br>8. Pregnancy or breastfeeding.<br>9. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (approved/investigational COVID-19 antivirals and other off-label drugs recommended by local health authorities are permitted).<br>10. Patients who in the opinion of the treating physician should not participate in this program (ex: severe acute respiratory distress syndrome [ARDS], septicaemia).<br> | Moderate-to-severe COVID-19 pneumonia <br>MedDRA version: 23.0
Level: LLT
Classification code 10053983
Term: Corona virus infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: hzVSF-v13<br>Product Code: [hzVSF-v13]<br>Pharmaceutical Form: Solution for infusion<br>Current Sponsor code: hzVSF-v13<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br> | Timepoint(s) of evaluation of this end point: Safety endpoints<br>- Up to day 30 after the final dose of the treatment; after this period, only serious adverse events suspected of being related to study treatment are to be reported<br>- Vital signs up to day 60; laboratory parameters up to day 28.<br>Efficacy endpoints<br>- Day 28<br>- Up to day 60<br>- Up to day 60<br>- Day 28 and day 60<br>- Day 7, 14, 21, 28 and 60<br>- Up to day 60<br>Pharmacodynamic endpoint<br>- Up to day 28;Secondary Objective: -;Main Objective: - To preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia.<br>- To characterize the pharmacodynamic effects of the hzVSF-v13 doses.;Primary end point(s): Safety endpoints<br>- Incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.<br>- Change from baseline in vital signs and clinical laboratory test results.<br>Efficacy endpoints<br>- Clinical failure at Day 28, defined as any of:<br>• Death<br>• Respiratory failure (patient is intubated)<br>• Patient is in ICU<br>- Clinical Improvement, defined as a decrease of at least 2 points on the WHO ordinal scale:<br>0. Uninfected: no clinical or virologic evidence of infection<br>1. Ambulatory: no limitation of activities<br>2. Ambulatory: limitation of activities<br>3. Hospitalized with mild disease: no oxygen therapy<br>4. Hospitalized with mild disease: oxygen by mask or nasal prongs<br>5. Hospitalized with severe disease: non-invasive ventilation or high-flow oxygen<br>6. Hospitalized with severe disease: intubation and mechanical ventilation<br>7. Hospitalized with severe disease: ventilation + additional organ support: vasopressors, renal replacement therapy, extracorporeal membrane oxygenation<br>8. Death<br>- Time to clinical improvement, defined as the time from randomization to clinical improvement as described above.<br>- Rate of overall survival at Day 28 and Day 60.<br>- Cumulative mortality rate at Days 7, 14, 21, 28, and 60.<br>- Time to hospital discharge or “ready for discharge” (i.e. normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or = 2L supplemental oxygen).<br>Pharmacodynamic endpoint<br>Serum tumour necrosis factor (TNF)-a, interleukin (IL)-1ß, IL-6 and C-reactive protein (CRP) levels at baseline and at specified times after initiation of study drug. If available, the same assessments are to be performed in BAL samples.→Timepoint(s) of evaluation of this end point: Safety endpoints<br>- Up to day 30 after the final dose of the treatment; after this period, only serious adverse events suspected of being related to study treatment are to be reported<br>- Vital signs up to day 60; laboratory parameters up to day 28.<br>Efficacy endpoints<br>- Day 28<br>- Up to day 60<br>- Up to day 60<br>- Day 28 and day 60<br>- Day 7, 14, 21, 28 and 60<br>- Up to day 60<br>Pharmacodynamic endpoint<br>- Up to day 28;Primary end point(s): Safety endpoints<br>- Incidence and severity of adverse events according to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v5.0.<br>- Change from baseline in vital signs and clinical laboratory test results.<br>Efficacy endpoints<br>- Clinical failure at Day 28, defined as any of:<br>• Death<br>• Respiratory failure (patient is intubated)<br>• Patient is in ICU<br>- Clinical Improvement, defined as a decrease of at least 2 points on the WHO ordinal scale:<br>0. Uninfected: no clinical or virologic evidence of infection<br>1. Ambulatory: no limitation of activities<br>2. Ambulatory: limitation of activities<br>3. Hospitalized with mild disease: no oxygen therapy<br>4. Hospitalized with mild disease: oxygen by mask or nasal prongs<br>5. Hospitalized with severe disease: non-invasive ventilation or high-flow oxygen<br>6. Hospitalized with severe disease: intubation and mechanical ventilation<br>7. Hospitalized with severe disease: ventilation + additional organ support: vasopressors, renal replacement therapy, extracorporeal membrane oxygenation<br>8. Death<br>- Time to clinical improvement, defined as the time from randomization to clinical improvement as described above.<br>- Rate of overall survival at Day 28 and Day 60.<br>- Cumulative mortality rate at Days 7, 14, 21, 28, and 60.<br>- Time to hospital discharge or “ready for discharge” (i.e. normal body temperature and respiratory rate, and stable oxygen saturation on ambient air or = 2L supplemental oxygen).<br>Pharmacodynamic endpoint<br>Serum tumour necrosis factor (TNF)-a, interleukin (IL)-1ß, IL-6 and C-reactive protein (CRP) levels at baseline and at specified times after initiation of study drug. If available, the same assessments are to be performed in BAL samples.;Secondary Objective: -;Main Objective: - To preliminarily investigate the safety and efficacy of two doses of hzVSF-v13 + SOC vs. placebo + SOC for the treatment of COVID-19 pneumonia.<br>- To characterize the pharmacodynamic effects of the hzVSF-v13 doses. | | | | Yes | False | | |
| EUCTR2020-001325-31-NL | 5 April 2021 | RDG-PET/CT imaging in COVID-19 patients. | [68Ga]Ga-DOTA-(RGD)2 PET/CT imaging of activated endothelium in lung parenchyma of COVID-19 patients. - RDG-PET/CT imaging in COVID-19 patients. | | Radboud University Medical Center | 07/04/2020 | 20200407 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001325-31 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 20/05/2020 | 10 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Netherlands | Nuclear Medicine Research Office | | Geert Grooteplein zuid 10 | Michel.deGroot@radboudumc.nl | +3124367243 | Radboud University Medical Center | Inclusion criteria: <br>• A microbiologically proven SARS-CoV-19 infection;
<br>• Pulmonary involvement as demonstrated on recent (<1 week) chest CT;
<br>• Enrolled in the BioMarCo-19 study (CMO2020-6344);
<br>• More than or equal to 18 years of age;
<br>• Ability to provide written informed consent.
<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 3<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 7<br> | Exclusion criteria: <br>• Contra-indication for PET:
<br> o Pregnancy;
<br> o Breast-feeding;
<br> o Severe claustrophobia.
<br>• Contra-indication for administration of iodine-containing contrast agents;
<br>• Other serious illness, e.g. history of malignancies
<br>;• Estimated creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula (or local institutional standard method).<br> | Maximum 10 patients from the Infectious Diseases ward with proven COVID-19 infection and pulmonary abnormalities on contrast-enhanced CT undergo static PET scans after injection of 70 µg (200 MBq) [68Ga]Ga-DOTA-(RGD)2. <br>MedDRA version: 20.1
Level: HLT
Classification code 10047468
Term: Viral lower respiratory tract infections
System Organ Class: 100000004855
<br>MedDRA version: 20.1
Level: HLT
Classification code 10047483
Term: Viral upper respiratory tract infections
System Organ Class: 100000004855
<br>MedDRA version: 21.1
Level: LLT
Classification code 10038701
Term: Respiratory insufficiency
System Organ Class: 100000004855
;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] | <br>Product Name: [68Ga]Ga-DOTA-E-(cRGDfK)2<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: INN not yet been requested to the WHO<br>Other descriptive name: [68Ga]Ga-DOTA-(RGD)2<br>Concentration unit: MBq megabecquerel(s)<br>Concentration type: range<br>Concentration number: 100-1000<br><br> | Timepoint(s) of evaluation of this end point: LVLS.;Primary end point(s): The main study parameter is the uptake of [68Ga]Ga-DOTA-(RGD)2 in the lesions as quantified by PET/CT (SUVmean ±SD, SUVmax ±SD and SUVpeak ±SD).;Secondary Objective: 1) To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and abnormal findings on contrast-enhanced CT scan of the chest<br>2) To assess the spatial correlation between [68Ga]Ga-DOTA-(RGD)2 and subtraction CT of the chest<br>3) To assess the correlation between [68Ga]Ga-DOTA-(RGD)2 and blood-based biomarkers (BioMarCo-19 study, CMO 2020-6344)<br>4) To explore the correlation between [68Ga]Ga-DOTA-(RGD)2 uptake and clinical course of disease<br>;Main Objective: The primary objective of this study is to demonstrate and quantitate aberrant activation of the endothelium in the lung vasculature using [68Ga]Ga-DOTA-(RGD)2 PET/CT. | | | | Yes | True | parent | |
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| EUCTR2020-001038-36-DE | 5 April 2021 | Study to investigate the safety and effects of vaccines in adults. | A multi-site, Phase I/II, 2-part, dose escalation trial investigating the safety and immunogenicity of four prophylactic SARS-CoV-2 RNA vaccines against COVID-19 using different dosing regimens in healthy and immunocompromised adults - Phase I/II Trial Investigating the Safety and Effects of Four BNT162 Vaccines Against COVID-19 | | BioNTech SE | 14/04/2020 | 20200414 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001038-36 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 20/04/2020 | 618 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: <br>Double blind: <br>Parallel group: <br>Cross over: <br>Other: yes<br>Other trial design description: Part A: dose-escalation design and Part B: parallel cohorts <br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 4<br> | Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany | Clinical Study Management | | An der Goldgrube 12 | Ruben.Rizzi@BioNTech.de | 0049613190847593 | BioNTech SE | Inclusion criteria: <br>1. Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.<br><br>2. They must be willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (e.g., to practice social distancing and to follow good practices to reduce their chances of being infected or spreading COVID-19), and other requirements of the trial.<br><br>3. They must be able to understand and follow trial-related instructions.<br><br>4. For younger subject cohorts, volunteers must be aged 18 to 55 years, have a BMI over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0.<br><br>OR<br><br>For older adult cohorts, volunteers must be aged 56 to 85 years, have a BMI over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0.<br><br>OR<br><br>For the immunocompromised adult cohort (Cohort 13), volunteers must be aged 18 to 85 years, have a BMI over 19 kg/m2 and under 30 kg/m2, and weigh at least 50 kg at Visit 0.<br><br>5. They must be healthy, in the clinical judgment of the investigator, based on medical history, physical examination, 12-lead ECG, vital signs (systolic/diastolic blood pressure, pulse rate, body temperature, respiratory rate), and clinical laboratory tests (blood chemistry, hematology, and urine chemistry) at Visit 0.<br><br>Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 wks before enrollment, can be included.<br><br>OR<br><br>For the immunocompromised cohort (Cohort 13); volunteers who have previously received solid organ transplant, or peripheral blood stem cell transplantation =6 months after transplantation, or individuals with HIV infection with a CD4+ T-cell count of =200 x 106 /L at Visit 0. Individuals with lower T-cell counts will be excluded from the trial on the basis that this represents a significant medical complication. In the clinical judgment of the investigator, volunteers must be immunocompromised but otherwise healthy. After consultation with the Medical Monitor, this may include individuals receiving immunosuppressant therapy due to another confounding disease at least 2 wks prior to enrollment and/or at least 6 wks following immunization with BNT162b2, and/or individuals with immunosuppressive treatment of an autoimmune disease if the disease is stable.<br><br>6. WOCBP must have a negative beta-human chorionic gonadotropin urine test at Visit 0 and Visit 1. Women that are postmenopausal or permanently sterilized will be considered as not having reproductive potential.<br><br>7. WOCBP must agree to practice a highly effective form of contraception during the trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization. WOCBP must agree to require their male partners to use condoms during sexual contact (unless male partners are sterilized or infertile).<br><br>8. WOCBP must confirm that they practiced at least one highly effective form of contraception for the 14 d prior to Visit 0.<br><br>9. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during trial, starting after Visit 0 and continuously until 60 d after receiving the last immunization.<br><br>10. Men who are sexually active with a WOCBP and have not had a vasectomy must agree to practice a highly effective form of contraception with their female partner of childbearing potential during the trial, starting after Visit 0 and continuous | Exclusion criteria: <br>Volunteers are excluded from the trial if they meet or present any of the following criteria:<br><br>1. Have had any acute illness, as determined by the investigator, with or without fever, within 72 h prior to the first immunization. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the investigator, the residual symptoms will not compromise their wellbeing if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.<br><br>2. Are breastfeeding on the day of Visit 0 or who plan to breastfeed during the trial, starting after Visit 0 and continuously until at least 90 d after receiving the last immunization.<br><br>3. Have a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP.<br><br>4. Had any medical condition or any major surgery (e.g., requiring general anesthesia) within the past 5 years which, in the opinion of the investigator, could compromise their wellbeing if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments. See the inclusion criteria 5 for non-excluded medical conditions for Cohort 13.<br><br>5. Have any surgery planned during the trial, starting after Visit 0 and continuously until at least 90 d after receiving the last immunization.<br><br>6. Had any chronic use (more than 21 continuous days) of any systemic medications, including immunosuppressants or other immune-modifying drugs (except for Cohort 13), within the 6 months prior to Visit 0 unless in the opinion of the investigator, the medication would not prevent, limit, or confound the protocol-specified assessments or could compromise subject safety. Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 wks before enrollment, can be included.<br><br>7. Received any vaccination within the 28 d prior to Visit 0.<br><br>8. Had administration of any immunoglobulins and/or any blood products within the 3 months prior to Visit 0.<br><br>9. Had administration of another investigational medicinal product including vaccines within 60 d or 5 half-lives (whichever is longer), prior to Visit 0.<br><br>10. Have a known history or a positive test for any of Hepatitis B, or Hepatitis C, or HIV 1 or 2 (except for Cohort 13) within the 30 d prior to Visit 0.<br><br>11. Have a positive PCR-based test for SARS-CoV-2 within the 30 d prior to Visit 1.<br><br>12. Have a positive drugs of abuse (for amphetamines, benzodiazepines, barbiturates, cocaine, cannabinoids, opiates, methadone, methamphetamines, phencyclidine, and tricyclic antidepressants) result at Visit 0 or Visit 1.<br><br>13. Have a positive breath alcohol test at Visit 0 or Visit 1.<br><br>14. Previously participated in an investigational trial involving lipid nanoparticles.<br><br>15. Are subject to exclusion periods from other investigational trials or simultaneous participation in another clinical trial. When entering the follow-up phase, i.e., after completing the EoT visit, subjects are allowed to participate in other clinical trials not investigating COVID-19 vaccines or treatments.<br><br>16. Have any affiliation with the trial site (e.g., are close relative of the investigator or dependent person, such as an employee or student of the trial site).<br><br>17. Have a history (within the past 5 years) of substance abuse or known medical, ps | Protection against COVID-19 <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: BNT162a1<br>Product Code: RBL063.3<br>Pharmaceutical Form: Concentrate for solution for injection<br><br>Product Name: BNT162b1<br>Product Code: RBP020.3<br>Pharmaceutical Form: Concentrate for solution for injection<br><br>Product Name: BNT162b2<br>Product Code: RBP020.2<br>Pharmaceutical Form: Concentrate for solution for injection<br><br>Product Name: BNT162c2<br>Product Code: RBS004.2<br>Pharmaceutical Form: Concentrate for solution for injection<br><br> | Timepoint(s) of evaluation of this end point: see Clinical Trial Protocol, Section 9.4.2 Primary endpoints;Secondary Objective: To describe the immune response in healthy adults after SD or P/B immunization measured by a functional antibody titer, e.g., virus neutralization test or an equivalent assay available by the time of trial conduct.;Main Objective: To describe the safety and tolerability profiles of prophylactic BNT162 vaccines in healthy adults after single dose (SD; prime only) or prime/boost (P/B) immunization;Primary end point(s): * Solicited local reactions at the injection site (pain, tenderness, erythema/redness, induration/swelling) recorded up to 7 d after each immunization (trial days 8 and 29). <br>* Solicited systemic reactions (nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) recorded up to 7 d after each immunization (trial days 8 and 29). <br>* The proportion of subjects with at least 1 unsolicited treatment-emergent adverse event (TEAE): <br>- For BNT162a1, BNT162b1, BNT162b2, and BNT162c2 (P/B): occurring up to 21 d after the prime immunization (trial day 22) and 28 d after the boost immunization (trial day 50). <br>- For BNT162c2 (SD): The proportion of subjects with at least 1 unsolicited TEAE occurring up to 28 d after the immunization (trial day 29). | | | | Yes | True | parent | |
| → | EUCTR2018-003377-97-SE | 5 April 2021 | Long term effect on immune response after pneumococcal vaccination in patients with chronic lymphocytic leukemia and evaluation of the effect of revaccination. | Long term effect on immune response after pneumococcal vaccination in patients with chronic lymphocytic leukemia and evaluation of the effect of revaccination. | | Swedish CLL-group | 05/11/2018 | 20181105 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2018-003377-97 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 18/12/2018 | 126 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): yes
| Sweden | Dept of Medicine, Hematology | | Örebro University Hospital | bertil.uggla@regionorebrolan.se | +46196027665 | Region Örebro län | Inclusion criteria: <br>CLL patients<br>CLL patients earlier included in the Pneumococcal vaccination study 0887x1-20003 (EudraCT No: 2009-012642-22), who have received either PCV13 or PPSV23 are eligible for evaluation of the long-term immune response. The median age of the patient group was at inclusion 70 years (range 46-87) with an equal number men and women (65/63). The same patients are eligible for revaccination if they do not meet any exclusion criteria. Ongoing or recent CLL specific treatment is not an exclusion criteria. <br><br>Controls<br>A control group (n=40) of immunocompetent subjects will be recruited in Region Örebro County. The control group will be matched to the CLL group by age and gender. For inclusion they should have been vaccinated with either PCV13 (n=20) or PPSV23 (n=20) approximately 3-5 years ago and not meet any exclusion criteria. They will subsequently be eligible for long-term immune response and revaccination according to the study protocol. <br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 41<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 105<br> | Exclusion criteria: <br>CLL patients<br>1. Patients receiving high dose corticosteroids ( =20 mg Prednisolone) or other immunosuppressive drugs that is not part of active CLL treatment<br>2. Patients who have had an allergic reaction to any vaccination in the past<br>3. Patients with a positive DAT (Direct Antiglobulin Test) or known present or previous hemolysis, ITP and Guillain-Barre<br>4. Patients failing to give informed consent<br>5. Patients with ongoing immunoglobulin therapy<br>6. Patients with known HIV infection<br>7. Patients who have received a pneumococcal vaccine outside the study protocol within the last 12 months<br>8. Active febrile infection<br>9. Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection <br><br>Controls<br>1. Serious chronic disorder including chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen treatment, end-stage renal disease, clinically unstable cardiac disease or any other disorder that, in the investigator’s opinion, excludes the subject from participating in the study;<br>2. Known or suspected immunodeficiency or other conditions associated with immunosuppression including immunoglobulin class/subclass deficiencies with or without substitution treatment, splenectomy in the medical history, generalized malignancy, human immunodeficiency virus (HIV) infection, haematological malignancies, bone marrow or organ transplant in the medical history;<br>3. Subjects receiving treatment with high dose corticosteroids (=20 mg Prednisolone) or other immunosuppressive drugs, or planned to receive through study participation;<br>4. Subjects who have had an allergic reaction to any component of PCV13 in the past;<br>5. Subjects with known present or previous hemolysis, ITP and Guillain-Barre;<br>6. Subjects failing to give informed consent;<br>7. Subjects who have received a pneumococcal vaccine after the primary vaccination aproximately 3-5 years ago;<br>8. Active febrile infection;<br>1.9. Increased bleeding risk due to severe thrombocytopenia or other coagulopathies that would, in the opinion of the investigator, contraindicate intramuscular injection (for treatment with oral anticoagulation therapy, see section 7.3).<br><br><br> | The aim of the study is to evaluate pneumococcal vaccination strategy with PPSV23 and PCV13 in patients with chronic lymphocytic leukemia (CLL) initially randomized in a clinical study.;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | <br>Trade Name: Pneumovax<br>Product Name: Pneumovax<br>Pharmaceutical Form: Solution for injection in pre-filled syringe<br><br>Trade Name: Prevenar<br>Product Name: Prevenar<br>Pharmaceutical Form: Suspension for injection in pre-filled syringe<br><br>Trade Name: Covid-19 vaccine, all vaccines with marketing authorisation in Sweden are allowed.<br>Product Name: Covid-19 vaccine<br>Product Code: N/A<br>Pharmaceutical Form: Concentrate for solution for injection<br><br> | Main Objective: 1) To determine and compare the sustained immune response 3-5 years after vaccination with a single dose of 13-valent pneumococcal conjugated vaccine (PCV13, Prevenar13®) or conventional 23-valent capsular polysaccharide vaccine (PPSV23, Pneumovax®) in the cohort from our previous randomized phase III trial. <br><br>2) To study the effect of revaccination with PCV13 in both vaccination groups and to investigate if there is an additive effect of another dose of PCV13 in patients with CLL. For the group that did not receive PPSV23 in the randomized trial, this vaccine will be given to broaden the serotype response and determine the additive effect after PCV13 vaccination. <br>;Secondary Objective: 1) To determine the prevalence of pneumococcal colonization in nasopharynx. <br>2) To determine the incidence of invasive pneumococcal disease in the study cohort.<br>3) To study the effect of pneumococcal revaccination on immune cells and cytokine levels. <br>4) To compare the sustained immune response between CLL patients and immunocompetent controls, 3-5 years after vaccination with PCV13 and PPSV23. <br>5) To compare the immune response between CLL patients and immunocompetent controls, after revaccination with one dose of PCV13.<br>6) To compare the prevalence of pneumococcal colonization and incidence of invasive pneumococcal disease between CLL patients and immunocompetent controls after vaccination and revaccination.<br>7) To compare the effect of pneumococcal revaccination on immune cells and cytokine levels between CLL patients and immunocompetent controls.<br>8) To compare the immune response after SARS-CoV-2 vaccination to the immune response after pneumococcal revaccination.<br>;Primary end point(s): 1) To study the long-term immune response between the two groups 3-5 years after vaccination with PCV13 or PPSV23, measured as the proportion of subjects with a positive vaccination response in each of the two groups.<br><br>2) To study the short-term immune response 8 weeks and 16 weeks after revaccination of the initial PCV 13 Group A with PCV13/PPSV23 and of the initial PPSV23 Group B with PCV13/PCV13, measured as the proportion of subjects with a positive vaccination response pre- and post- revaccination.<br><br><br><br><br><br>;Timepoint(s) of evaluation of this end point: 8 and 16 weeks after revaccination.→Timepoint(s) of evaluation of this end point: 8 and 16 weeks after revaccination.;Primary end point(s): 1) To study the long-term immune response between the two groups 3-5 years after vaccination with PCV13 or PPSV23, measured as the proportion of subjects with a positive vaccination response in each of the two groups.<br><br>2) To study the short-term immune response 8 weeks and 16 weeks after revaccination of the initial PCV 13 Group A with PCV13/PPSV23 and of the initial PPSV23 Group B with PCV13/PCV13, measured as the proportion of subjects with a positive vaccination response pre- and post- revaccination.<br><br><br><br><br><br>;Secondary Objective: 1) To determine the prevalence of pneumococcal colonization in nasopharynx. <br>2) To determine the incidence of invasive pneumococcal disease in the study cohort.<br>3) To study the effect of pneumococcal revaccination on immune cells and cytokine levels. <br>4) To compare the sustained immune response between CLL patients and immunocompetent controls, 3-5 years after vaccination with PCV13 and PPSV23. <br>5) To compare the immune response between CLL patients and immunocompetent controls, after revaccination with one dose of PCV13.<br>6) To compare the prevalence of pneumococcal colonization and incidence of invasive pneumococcal disease between CLL patients and immunocompetent controls after vaccination and revaccination.<br>7) To compare the effect of pneumococcal revaccination on immune cells and cytokine levels between CLL patients and immunocompetent controls.<br>8) To compare the immune response after SARS-CoV-2 vaccination to the immune response after pneumococcal revaccination.<br>;Main Objective: 1) To determine and compare the sustained immune response 3-5 years after vaccination with a single dose of 13-valent pneumococcal conjugated vaccine (PCV13, Prevenar13®) or conventional 23-valent capsular polysaccharide vaccine (PPSV23, Pneumovax®) in the cohort from our previous randomized phase III trial. <br><br>2) To study the effect of revaccination with PCV13 in both vaccination groups and to investigate if there is an additive effect of another dose of PCV13 in patients with CLL. For the group that did not receive PPSV23 in the randomized trial, this vaccine will be given to broaden the serotype response and determine the additive effect after PCV13 vaccination. <br> | | | | Yes | False | | |
| → | EUCTR2020-003349-12-IE | 5 April 2021 | This is a proof of principle / feasibility study aiming to evaluate the effect of nebulised unfractionated heparin on procoagulant markers related to acute respiratory distress syndrome in patients invasively ventilated for Covid 19 lung disease. | Can Nebulised HepArin Reduce acuTE lung injury in Patients with SARS-CoV-2 Requiring Mechanical Ventilation in Ireland - Charter Trial | | NUIG | 14/08/2020 | 20200814 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-003349-12 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 09/10/2020 | 40 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Standard of care<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Ireland | Prof John Laffey | | University Road | john.laffey@nuigalway.ie | 35391524411 | National University of Ireland Galway | Inclusion criteria: <br>To be eligible, a patient must satisfy all these inclusion criteria:<br>1. Confirmed or suspected COVID-19. Note, if ‘suspected’, results must be pending or testing intended<br>2. Ability to obtain informed consent/assent to participate in study<br>3. Age 18 years or older<br>4. Requiring high flow nasal oxygen or positive pressure ventilator support or invasive mechanical ventilation for a time period of no greater than 48 hours<br>5. D-dimers > 200 ng/ml<br>6. PaO2 to FIO2 ratio less than or equal to 300<br>7. Acute opacities on chest imaging affecting at least one lung quadrant. Note ‘Acute opacities’ do not include effusions, lobar/lung collapse or nodules<br>8. Currently in a higher level of care area designated for inpatient care of patients where therapies including non-positive pressure ventilatory support can be provided.<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 40<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 40<br> | Exclusion criteria: <br>To be eligible, a patient must have none of these exclusion criteria:<br>1. Enrolled in another clinical trial that is unapproved for co-enrolment <br>2. Heparin allergy or heparin-induced thrombocytopaenia<br>3. APTT > 100 seconds <br>4. Platelet count < 50 x 109 per L<br>5. Pulmonary bleeding, which is frank bleeding in the trachea, bronchi or lungs with repeated haemoptysis or requiring repeated suctioning<br>6. Uncontrolled bleeding<br>7. Pregnant or suspected pregnancy (Urine or serum HCG will be recorded)<br>8. Receiving or about to commence ECMO or HFOV<br>9. Myopathy, spinal cord injury, or nerve injury or disease with a likely prolonged incapacity to breathe independently e.g. Guillain-Barre syndrome <br>10. Usually receives home oxygen<br>11. Dependent on others for personal care due to physical or cognitive decline (pre-morbid status) <br>12. Death is imminent or inevitable within 24 hours<br>13. The clinical team would not be able to set up the study nebuliser and ventilator circuit as required including with active humidification <br>14. Clinician objection.<br>15. The use or anticipated use of nebulised tobramycin during this clinical episode<br>16. Any other specific contraindication to anticoagulation including prophylactic anticoagulation not otherwise listed here<br>17. Relapse in clinical condition in patient that had weaned from advanced respiratory support<br><br> | This trial will be carried out in invasively ventilated ICU patients with suspected or confirmed COVID-19 infection;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Heparin Sodium <br>Product Name: Heparin Sodium<br>Product Code: PL 29831/0111<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: HEPARIN SODIUM<br>CAS Number: 9041-08-1<br>Other descriptive name: Heparin<br>Concentration unit: IU/ml international unit(s)/millilitre<br>Concentration type: equal<br>Concentration number: 5000-<br><br> | Timepoint(s) of evaluation of this end point: Nebulised heparin is administered 6-hourly from enrolment to day 10 post enrolment, provided the patient is receiving invasive mechanical ventilation. Data collection will be completed at day 60. ;Primary end point(s): Nebulised heparin is administered 6-hourly from enrolment to day 10 post enrolment, provided the patient is receiving invasive mechanical ventilation. Data collection will be completed at day 60. ;Main Objective: Effect of nebulised heparin on d-dimer profile, assessed via d-dimer AUC and via a mixed effects model, with data collected on days 1, 3, 5 and 10.<br>Safety of nebulised heparin delivered by Aerogun vibrating-mesh nebuliser in patients with COVID-19 induced severe respiratory failure, as measured by the incidence of severe adverse events.<br> <br>;Secondary Objective: -Determine the impact nebulised heparin (NH)on indices of oxygenation measured 6 hourly<br>-Determine the effect of NH on ventilatory ratio measured every 6 hours.<br>-Determine the effect of NH on pulmonary compliance measured on days 1,3,5 and 10.<br>-Effect of NH on other inflammatory and soluble TNF receptor 1 and coagulation indices will be assessed. <br>-In this study, ‘day 0’ describes the period from randomisation to midnight on the day of enrolment, ‘day 1’ the first calendar day after the day of enrolment, ‘day 2’ the second calendar day after the day of enrolment, and so forth.<br>-Number tracheotomised to day 28 <br>-Time to separation from the ICU to day 28, where non-survivors to day 28 are treated as though not separated from intensive care<br>-Survival to day 28; Survival to day 60; to hospital discharge, censored at day 60- <br>→Timepoint(s) of evaluation of this end point: Nebulised heparin is administered 6-hourly from enrolment to day 10 post enrolment, provided the patient is receiving invasive mechanical ventilation. Data collection will be completed at day 60. ;Primary end point(s): Nebulised heparin is administered 6-hourly from enrolment to day 10 post enrolment, provided the patient is receiving invasive mechanical ventilation. Data collection will be completed at day 60. ;Secondary Objective: -Determine the impact nebulised heparin (NH)on indices of oxygenation measured 6 hourly<br>-Determine the effect of NH on ventilatory ratio measured every 6 hours.<br>-Determine the effect of NH on pulmonary compliance measured on days 1,3,5 and 10.<br>-Effect of NH on other inflammatory and soluble TNF receptor 1 and coagulation indices will be assessed. <br>-In this study, ‘day 0’ describes the period from randomisation to midnight on the day of enrolment, ‘day 1’ the first calendar day after the day of enrolment, ‘day 2’ the second calendar day after the day of enrolment, and so forth.<br>-Number tracheotomised to day 28 <br>-Time to separation from the ICU to day 28, where non-survivors to day 28 are treated as though not separated from intensive care<br>-Survival to day 28; Survival to day 60; to hospital discharge, censored at day 60- <br>;Main Objective: Effect of nebulised heparin on d-dimer profile, assessed via d-dimer AUC and via a mixed effects model, with data collected on days 1, 3, 5 and 10.<br>Safety of nebulised heparin delivered by Aerogun vibrating-mesh nebuliser in patients with COVID-19 induced severe respiratory failure, as measured by the incidence of severe adverse events.<br> <br> | | | | Yes | False | | |
| EUCTR2020-003363-25-DK | 5 April 2021 | Higher vs. Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Oxygen Deficiency: the COVID STEROID 2 trial | Higher vs. Lower Doses of Dexamethasone in Patients with COVID-19 and Severe Hypoxia: the COVID STEROID 2 trial
- COVID STEROID 2 | | Department of Intensive Care, Rigshospitalet | 17/07/2020 | 20200717 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-003363-25 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 18/08/2020 | 1000 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Lower dose (6 mg) of the same medical product as used in intervention group (dexamethasone)<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| India;Sweden;Denmark | Clinical Trials Information | | Blegdamsvej 9 | covid-steroid@cric.nu | +4535457237 | Department of Intensive Care, Rigshospitalet | Inclusion criteria: <br>All the following criteria must be fulfilled: <br>- Aged 18 years or above AND<br>- Confirmed SARS-CoV-2 (COVID-19) requiring hospitalisation AND<br>- Use of one of the following:<br>• Invasive mechanical ventilation OR<br>• Non-invasive ventilation or continuous use of continuous positive airway pressure (CPAP) for hypoxia OR<br>• Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 400<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 600<br> | Exclusion criteria: <br>We will exclude patients who fulfil any of the following criteria: <br>- Use of systemic corticosteroids in doses higher than 6 mg dexamethasone equivalents for other indications than COVID-19 <br>- Use of systemic corticosteroids for COVID-19 for 5 days or more <br>- Invasive fungal infection<br>- Active tuberculosis<br>- Fertile woman (< 60 years of age) with positive urine human gonadotropin (hCG) or plasma-hCG<br>- Known hypersensitivity to dexamethasone<br>- Previously randomised into the COVID STEROID 2 trial <br>- Informed consent not obtainable<br><br> | Adult patients with COVID-19 and severe hypoxia. <br>MedDRA version: 23.1
Level: LLT
Classification code 10084401
Term: COVID-19 respiratory infection
System Organ Class: 100000004862
<br>MedDRA version: 21.1
Level: PT
Classification code 10021143
Term: Hypoxia
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Dexavit<br>Product Name: Dexavit<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Dexamethasone<br>CAS Number: 312-93-6<br>Other descriptive name: DEXAMETHASONE PHOSPHATE<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 4-<br><br>Trade Name: Dexavit<br>Product Name: Dexavit<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Dexamethasone<br>CAS Number: 312-93-6<br>Other descriptive name: DEXAMETHASONE PHOSPHATE<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 4-<br><br>Trade Name: Isotonic Sodium Chloride (0.9%)<br>Product Name: Sodium Chloride<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Sodium Chloride<br>Other descriptive name: SODIUM CHLORIDE SOLUTION 0.9%<br>Concentration unit: % (W/V) percent weight/volume<br>Concentration type: equal<br>Concentration number: 0.9-<br><br> | Timepoint(s) of evaluation of this end point: Day 28;Primary end point(s): Days alive without life support (i.e. invasive mechanical ventilation, circulatory support or renal replacement therapy) from randomisation to day 28.;Secondary Objective: Not applicable;Main Objective: To assess the effects of higher (12 mg) vs lower doses (6 mg) of intravenous dexamethasone on the number of days alive without life-support in adult patients with COVID-19 and severe hypoxia. | | | | Yes | True | parent | |
| → | EUCTR2020-001644-25-FR | 5 April 2021 | A Phase 2 Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19 | A Phase 2 Randomized Study of the Efficacy and Safety of Acalabrutinib with Best Supportive Care Versus Best Supportive Care in Subjects Hospitalized with COVID-19 - CALAVI | | Acerta Pharma B.V. | 11/04/2020 | 20200411 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001644-25 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 06/05/2020 | 428 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Best supportive care<br>Number of treatment arms in the trial: 3<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Sweden;Italy;Germany;Spain;France;United States | Clinical Trial Call Center | | 121 Oyster Point Blvd | acertamc@dlss.com | +1888 2929613 | Acerta Pharma B.V. | Inclusion criteria: <br>For Part 1 (Randomized cohort):
<br>1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)
<br>2. Men and women =18 years of age at the time of signing the informed consent form
<br>3. Confirmed COVID-19 infection confirmed per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other bodily fluid] within 3 weeks of study entry) with suspected pneumonia requiring hospitalization and oxygen saturation <94% on room air or requires 2-5 L/min of oxygen with at least one of the follow laboratory values:
<br>(a) Ferritin > 300 ng/mL for men and > 150 ng/mL for women
<br>(b) C-reactive protein (CRP) = 10 mg/L
<br>(c) D-dimer > 1 mg/L
<br>(d) Absolute lymphocyte count < 1000 cells/µL
<br>4. Able to swallow capsules or receive delivery of emptied capsule via a nasogastric (NG) or an enteral feeding tube
<br>5. Willing to follow contraception guidelines
<br>
<br>For Part 2 Intensive Care Unit (ICU Cohort):
<br>1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations)
<br>2. Men and women =18 years of age at the time of signing the informed consent form
<br>3. Confirmed COVID-19 infection requiring ICU admission and requiring = 6 L/min of oxygen or PaO2/FiO2 =300 mm Hg)
<br>4. Able to swallow capsules or receive delivery of emptied capsule via a nasogastric (NG) or an enteral feeding tube
<br>5. Willing to follow contraception guidelines
<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 300<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 128<br> | Exclusion criteria: <br>For Part 1 and Part 2 (All Subjects):
<br>1. Pregnant or breast feeding
<br>2. Are not committed to aggressive management. For example, the subject’s family or primary physician are unwilling to place the subject on mechanical ventilation or an advanced directive to withhold life support, with the exception of cardiopulmonary resuscitation, is present.
<br>3. Suspected, uncontrolled active bacterial, fungal, viral, or other infection (besides COVID 19)
<br>4. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
<br>5. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, congestive heart failure (New York Heart Association [NYHA] Grade 3 or 4), or require home oxygen for a chronic lung disorder. Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll on study.
<br>6. Use of active systemic or inhaled corticosteroids. Subjects who stop active systemic or inhaled corticosteroids before the first dose of acalabrutinib will not be excluded.
<br>7. Concomitant use of JAK, PI3K, or Btk (other than acalabrutinib) inhibitors with acalabrutinib. Subjects who stop JAK or PI3K inhibitors before the first dose of acalabrutinib will not be excluded. Use of other Btk inhibitors must be stopped 30 days before the first dose of acalabrutinib.
<br>For Part 1:
<br>1. In ICU or on invasive mechanical ventilation or ECMO machine before randomization.
<br>2. Known medical resuscitation within 14 days of randomization
<br>
<br>For Part 2:
<br>1. Randomization to Part 1<br> | Subjects with life-threatening COVID-19 symptoms <br>MedDRA version: 20.0
Level: LLT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: acalabrutinib<br>Product Code: ACP-196<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: ACALABRUTINIB<br>CAS Number: 1420477-60-6<br>Current Sponsor code: ACP-196<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br> | Main Objective: The overall objective of the study is to evaluate the efficacy of adding acalabrutinib to BSC for the treatment of COVID-19;Primary end point(s): The primary endpoint is treatment failure rate, where treatment failure is defined as use of assisted ventilation or death. For the purpose of this study assisted ventilation is defined as noninvasive ventilation (eg, continuous positive airway pressure [CPAP] ventilation), invasive mechanical ventilation, or ECMO machine;Timepoint(s) of evaluation of this end point: Approximately 30 days;Secondary Objective: To assess pharmacokinetics of acalabrutinib and its active metabolite in subjects with COVID-19 when administered with BSC<br>→Primary end point(s): The primary endpoint is treatment failure rate, where treatment failure is defined as use of assisted ventilation or death. For the purpose of this study assisted ventilation is defined as noninvasive ventilation (eg, continuous positive airway pressure [CPAP] ventilation), invasive mechanical ventilation, or ECMO machine;Timepoint(s) of evaluation of this end point: Approximately 30 days;Secondary Objective: To assess pharmacokinetics of acalabrutinib and its active metabolite in subjects with COVID-19 when administered with BSC<br>;Main Objective: The overall objective of the study is to evaluate the efficacy of adding acalabrutinib to BSC for the treatment of COVID-19 | | | | Yes | True | parent | |
| EUCTR2020-001659-42-ES | 5 April 2021 | Study of antithrombin as prophylaxis of acute respiratory disease in patients with COVID-19 | Pilot study of antithrombin as prophylaxis of acute respiratory distress syndrome in patients with COVID-19 | | Fundación para la Investigación Biomédica de Córdoba | 20/04/2020 | 20200420 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001659-42 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 18/04/2020 | 46 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Best available treatment at site<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | Antonio Luque | | Edificio IMIBIC. Avenida Menéndez Pidal s/n | uicec@imibic.org | 0034671596070 | Fundación para la Investigación Biomédica de Córdoba | Inclusion criteria: <br>1. Age = 18 and <85 years<br>2. Diagnosis confirmed by COVID-19 PCR<br>3. Radiological image compatible with COVID-19<br>4. Present any of the following clinical-functional criteria considered RISK:<br>4.a. Respiratory distress: Tachypnea> 26 breaths / minute<br>4. b. PaO2 / FiO2 oxygenation index = 300<br>4.c. Alteration of one or more of the following parameters:<br>4.c.i. DD> 1,000 µg / L<br>4.c.ii. Ferritin> 800 ng / mL<br>4.c.iii. Lymphocytes <800 cells / µL<br>4.c.iv. PCR> 100 mg / L<br>4.c.v. LDH> 500 U / L<br>4.c.vi. IL-6> 15 pg / mL<br>5. Direct or delegated verbal informed consent<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 10<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 36<br> | Exclusion criteria: <br>1. Signs of active bleeding<br>2. Immunosuppression by cancer or transplant<br>3. Intolerance or allergy to AT or its components<br>4. Pregnancy<br> | Confirmed SARS-CoV-2 respiratory infection with poor prognostic factors <br>MedDRA version: 20.0
Level: LLT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
<br>MedDRA version: 20.1
Level: PT
Classification code 10061982
Term: Severe acute respiratory syndrome
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Anbinex<br>Product Name: HUMAN ANTITHROMBIN<br>Pharmaceutical Form: Powder and solvent for solution for injection<br>INN or Proposed INN: Antithrombin III<br>Other descriptive name: HUMAN ANTITHROMBIN<br>Concentration unit: IU international unit(s)<br>Concentration type: equal<br>Concentration number: 1000-<br><br> | Main Objective: Decrease the risk of developing ARDS and death in high-risk COVID-19 patients;Secondary Objective: - To evaluate the improvement in oxygenation at 12, 24, 48, 72 and 96 hours.<br>- To evaluate the improvement in analytical risk parameters for ARDS at 24, 48 and 72 hours.<br>- To evaluate the radiological improvement.<br>- To evaluate the rate of need for non-invasive and invasive mechanical ventilation.<br>- To evaluate the time of use of mechanical ventilation.<br>- To evaluate the mortality rate in hospital and one month after the pharmacological intervention.<br>- To reviews the safety profile of the established treatment.<br>- To Deepen in the anti-inflammatory mechanisms of AT.;Primary end point(s): Combined variable: mortality or worsening rate with need for non-invasive mechanical ventilation or with need for invasive mechanical ventilation.;Timepoint(s) of evaluation of this end point: Daily. | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2021-000868-30-NL | 5 April 2021 | The efficacy and safety of COVID-19 vaccination in patients with a kidney disease | The immune-response and safety of COVID-19 vaccination in patients with chronic kidney disease, on dialysis, or living with a kidney transplant - The RECOVAC IR study | | RECOVAC consortium | 17/02/2021 | 20210217 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000868-30 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 17/02/2021 | 850 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Netherlands | study coordinator | | Hanzeplein 1 | a.l.messchendorp@umcg.nl | 00310503616161 | RECOVAC consortium | Inclusion criteria: <br>1. All patients should be eligible for COVID-19 vaccination as described by the instructions of the manufacturer.<br>2. Age of 18 years or older<br>3. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)<br>4. Either<br>- CKD4/5, with an eGFR <30 ml/min*1.73m2 by CKD-EPI<br>- Hemodialysis, or peritoneal dialysis<br>- Kidney transplant recipient at least 6 weeks after transplantation<br>- Partner, sibling, or other family member of participating patient with eGFR > 45 ml/min * 1,73 m2<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 570<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 280<br> | Exclusion criteria: <br>-History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) toany component of the study intervention(s).<br>-Multi-organ recipients<br>-Previous or active COVID-19 disease<br>-Active (haematological) malignancy<br>-Inherited immune deficiency<br>-Infection with Human Immunodeficency Virus (HIV)<br>-Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.<br> | COVID-19 is associated with increased morbidity and mortality in kidney transplant recipients (KTR) and patients with chronic kidneydisease (CKD). Therefore, potential efficacious SARS-CoV-2 vaccination would be of great clinical importance in these patients.However, SARS-CoV-2 vaccination studies have excluded KTR and patients with CKD so-far. This will be the subject of this trial. <br>MedDRA version: 20.0
Level: LLT
Classification code 10023438
Term: Kidney transplant
System Organ Class: 10042613 - Surgical and medical procedures
<br>MedDRA version: 20.0
Level: PT
Classification code 10061105
Term: Dialysis
System Organ Class: 10042613 - Surgical and medical procedures
<br>MedDRA version: 23.1
Level: PT
Classification code 10064848
Term: Chronic kidney disease
System Organ Class: 10038359 - Renal and urinary disorders
<br>MedDRA version: 23.1
Level: LLT
Classification code 10084465
Term: COVID-19 vaccination
System Organ Class: 10042613 - Surgical and medical procedures
<br>MedDRA version: 23.1
Level: LLT
Classification code 10084401
Term: COVID-19 respiratory infection
System Organ Class: 100000004862
<br>MedDRA version: 23.1
Level: LLT
Classification code 10084464
Term: COVID-19 immunization
System Organ Class: 10042613 - Surgical and medical procedures
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084272
Term: SARS-CoV-2 infection
System Organ Class: 100000004862
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084462
Term: SARS-CoV-2 vaccination
System Organ Class: 10042613 - Surgical and medical procedures
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084463
Term: SARS-CoV-2 immunisation
System Organ Class: 10042613 - Surgical and medical procedures
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Pharmaceutical Form: Solution for injection/infusion<br><br> | Timepoint(s) of evaluation of this end point: 28 days after complete vaccination;Primary end point(s): To assess the antibody response after SARS-CoV-2 vaccination in patients with CKD stages 4/5, on dialysis or alive with a kidney transplant as compared to controls.;Secondary Objective: Secondary endpoints include longevity of the immune response at 6 and 12 months and levels of SARS-CoV-2 specific T and B cell responses. Safety is a secondary endpoint which will be reported in terms of percentage of solicited local and systemic adverse events (AEs) graded according to severity.;Main Objective: To assess the efficacy and safety of vaccination against COVID-19 in patients with CKD4/5, patients on dialysis, and kidneytransplant recipients as compared to controls.<br><br>The primary endpoint is the antibody based immune response on day 28 after the second vaccination. Participants will be classified as<br>responders or non-responders. The percentage of responders of each patient cohort will be compared with the percentage responders in the control group.<br><br> | | | | Yes | False | | |
| → | EUCTR2020-001760-29-ES | 5 April 2021 | Phase III clinical trial to evaluate the efficacy and safety of inhaled ethanol in the treatment of early-stage COVID-19. | Phase II clinical trial to evaluate the efficacy and safety of inhaled ethanol in the treatment of early-stage COVID-19. - ALCOVID-19 | | Sociedad Española de Farmacia Hospitalaria | 19/11/2020 | 20201119 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001760-29 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 09/09/2020 | 156 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | Alejandro Guerra Hidalgo | | Calle Editor José Manuel Lara, número 28, piso 1, puerta B | secretaria@delosclinical.com | +34630157890 | C.R.O. Delos Clinical | Inclusion criteria: <br>1. Institutionalized men or women aged 65 or over at the time of signing the informed consent.<br>2. Patients capable of understanding the trial procedures and accepting their participation.<br><br>3. Diagnosis of COVID-19 confirmed by RT-PCR.<br><br>4. Initial stage of the disease diagnosed by:<br>- Less than 7 days from the appearance of the first symptoms.<br>- Absence of dyspnea<br>- Absence of pneumonia<br>- SO2> 93% or pO2> 70<br>- FR <25 rpm<br><br>5. Signature and date of informed consent before any study-related activity, including evaluations necessary for selection.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) no<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 156<br> | Exclusion criteria: <br>1. Impaired kidney function (creatinine> 2.5 times the normal limit), need for haemofiltration or impaired liver function (ALT or AST> 3 times the normal limits) or diagnosis of severe kidney failure.<br><br>2. Hypersensitivity, allergy or contraindications to the study treatments.<br><br>3. Inability to administer oxygen therapy using Ventimask®.<br><br>4. Diagnosis of any other pathology that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the study's objectives.<br><br>5. Consumption of any other drug that could disable him in the judgment of the investigator to participate in the study.<br><br>6. Other circumstances or difficulties that, in the investigator's opinion, may increase the subject's risk or reduce the possibilities of obtaining satisfactory data to achieve the objectives of the study.<br><br>7. Participation in another clinical study where they received an investigational drug in the 24 weeks prior to signing the informed consent.<br><br>8. Patients diagnosed with chronic bronchopneumopathy.<br><br>9. Patients with a history of epilepsy.<br><br>10. Patients with a history of alcoholism.<br><br>11. Treatment with anticonvulsant drugs used for the treatment of epilepsy and with a higher degree of interaction with ethanol: topiramate, carbamazepine, perampanel and stiripentol<br><br>12. Treatment with drugs that administered concomitantly with ethanol can cause the so-called “disulfiran-like effect”: disulfiran, metronidazole, tinidazole, chloramphenicol, levamisole, nitrofurantoin, isoniazid and griseofulvin.<br> | COVID-19;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Fórmula magistral de etanol 65º<br>Pharmaceutical Form: Nebulisation solution<br>INN or Proposed INN: Ethanol<br>CAS Number: 64-17-5<br>Current Sponsor code: Ethanol<br>Other descriptive name: ETHANOL<br>Concentration unit: % (V/V) percent volume/volume<br>Concentration type: equal<br>Concentration number: 65-<br>Pharmaceutical form of the placebo: Nebuliser solution<br>Route of administration of the placebo: Inhalation use<br><br> | Secondary Objective: 1. Evaluate the evolution of hypoxemia using the SaO2 / FiO2 index with respect to the nadir at 1, 2 and 4 weeks.<br><br>2. To evaluate the evolution of the viral load of the patients in the nasopharyngeal sample during the treatment period and subsequent follow-up.<br><br>3. Evaluate the number of patients who normalize body temperature, defined as axillary temperature <37.5 °, without antipyretic treatment for at least 48 hours on the 5th day of treatment.<br><br>4. Evaluate the safety of administering the experimental treatment.;Timepoint(s) of evaluation of this end point: Days 0, +13 and +27;Primary end point(s): Progression data: date and symptoms of progression;Main Objective: To assess the progression to more serious stages defined by pneumonia, respiratory distress, sepsis, septic shock or death at 14 days and 28 days of follow-up (according to the Spanish Ministry of Health classification of disease severity)→Main Objective: To assess the progression to more serious stages defined by pneumonia, respiratory distress, sepsis, septic shock or death at 14 days and 28 days of follow-up (according to the Spanish Ministry of Health classification of disease severity);Primary end point(s): Progression data: date and symptoms of progression;Timepoint(s) of evaluation of this end point: Days 0, +13 and +27;Secondary Objective: 1. Evaluate the evolution of hypoxemia using the SaO2 / FiO2 index with respect to the nadir at 1, 2 and 4 weeks.<br><br>2. To evaluate the evolution of the viral load of the patients in the nasopharyngeal sample during the treatment period and subsequent follow-up.<br><br>3. Evaluate the number of patients who normalize body temperature, defined as axillary temperature <37.5 °, without antipyretic treatment for at least 48 hours on the 5th day of treatment.<br><br>4. Evaluate the safety of administering the experimental treatment. | | | | No | False | | |
| EUCTR2020-006042-39-HU | 5 April 2021 | Safety and efficacy of Favipiravir | A randomized, double-blind, placebo-controlled study to assess the efficacy and safety of Favipiravir-HU compared to placebo as add-on therapy to standard of care in asymptomatic to mild severity COVID-19 patients - Favipiravir Clinical Trial | | Hungarian Ministry of Innovation and Technology - Representative: Hecrin Consortium | 12/01/2021 | 20210112 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-006042-39 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 19/02/2021 | 120 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Hungary | CRO | | Völgy street 41. | krisztina.hracs@adwareresearch.com | | AdWare Research Ltd. | Inclusion criteria: <br> Male or female patients between the ages of 18 and 65 years<br> Patients with PCR confirmed SARS-CoV-2 infection <br> Asymptomatic or have mild only symptoms<br> Signed Informed Consent Form and Patient Information Leaflet<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 120<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br> Pregnant or possibly pregnant patients or lactating females<br> Patients have moderate to severe or immediately life-threatening COVID-19<br> Major risk factor onset (Obesity, Diabetes, COPD, Hypertension) <br> Patients with SpO2 less than 95% without oxygen therapy<br> Patients with severe hepatic impairment equivalent to Grade C on Child-Pugh classification<br> Patients with renal impairment requiring dialysis<br> Patients with disturbed consciousness such as disturbed orientation<br>Female patients who are woman of childbearing potential and unable to consent to use of dual contraception from the start of favipiravir administration to 30 days after the end of favipiravir administration. Dual contraception is a combination of two of the following: Barrier method of contraception: condoms (male or female) with orwithout a spermicidal agent, diaphragm or cervical cap with spermicide; IUD; Hormone-based contraceptive; Tubal ligation<br> Male patients whose are unable to consent to use of barrier method of contraception (condom) the start of favipiravir administration to 90 days after the end of favipiravir administration. Male patients who are planning to donate sperm in 90 days after the start of favipiravir administration. <br>Patients with hereditary xanthinuria<br>Patient with severe uncontrolled hyperuricaemia<br>Patients receiving immunosuppressant<br>Patients who received interferon-alpha or drugs with reported antiviral activity against SARS-CoV-2 (hydroxychloroquine sulfate, chloroquine phosphate, lopinavir-ritonavir combination, ciclesonide, nafamostat mesylate, camostat mesylate, remdesivir, etc.) within 72 hours or Patients who receive forbidden concomitant medication<br>Any medical condition that the examining physician deems unsuitable for the patient to participate in the study<br><br><br> | Patients with PCR confirmed SARS-CoV-2 infection who are
asymptomatic or have mild symptoms will be enrolled <br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Favipiravir HU 200 mg hard capsules<br>Product Name: Favipiravir HU 200 mg hard capsules<br>Pharmaceutical Form: Capsule, hard<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: Day6 of the study ;Primary end point(s): <PRIM1> The primary endpoint of the study is the percentage of virus copy number at Day6 compared to baseline.<br><br>;Secondary Objective: Key secondary objectives<br>• To assess the study treatment’s effect on reduction of the time required for virus elimination. <br>• To assess the study treatment’s risk reduction effect. <br>• To assess the recovery time in patients who have developed symptoms, using clinical and radiological diagnostics<br>• To evaluate the safety and tolerability of the investigational product.<br>Secondary objectives<br>• To assess the study treatment’s risk reduction effect on overall mortality.<br>• To assess the study treatment’s risk reduction effect on achieving development of respiratory failure.<br>• To assess the study treatment’s risk reduction effect on need for intensive care unit.<br>• To assess the study treatment’s risk reduction effect on need for non-invasive respiratory support.<br>• To assess the study treatment’s risk reduction effect on need for invasive respiratory support.<br>• To assess the study treatment’s risk reduction effect on Acute Respiratory Distress Syndrome.<br>;Main Objective: The primary objective is to assess the efficacy of Favipiravir-HU compared to placebo as add-on treatment on reducing SARS-CoV-2 virus copy number as measured by quantitative PCR by nasopharyngeal sampling. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-001870-32-HU | 5 April 2021 | Study to assess efficacy and safety of DFV890 in patients with COVID-19 pneumonia and impaired respiratory function
| Phase 2, randomized, controlled, open label multi-center study to assess efficacy and safety of DFV890 for the treatment of SARS-CoV-2 infected patients with COVID-19 pneumonia and impaired respiratory function
| | Novartis Pharma AG | 05/05/2020 | 20200505 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001870-32 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 14/05/2020 | 120 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Standard of care<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany;Netherlands;Denmark;Spain;Hungary | Public Information Desk | | Bartók Béla út 43-47. | infoph.hungary@novartis.com | 00 36 1 457-6500 | Novartis Hungary Kft. | Inclusion criteria: <br>• Clinically diagnosed with the SARS-CoV-2 virus
<br>• Hospitalized with COVID-19-induced pneumonia
<br>• Impaired respiratory function, defined as peripheral oxygen saturation (SpO2) =93% on room air or partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) <300 millimeter of mercury (mmHg)
<br>• APACHE II score of =10 at time of randomization
<br>• C-reactive protein (CRP) =20 mg/L and/or ferritin level =600 µg/L
<br>• Body weight mass index of =18 to <40kg/m2
<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 60<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 60<br> | Exclusion criteria: <br>• Suspected active or chronic bacterial (including Mycobacterium tuberculosis), fungal, viral, or other infection (besides SARS-CoV-2)
<br>• In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
<br>• Intubated prior to randomization
<br>• Have received either oral anti-rejection, or immunomodulatory drugs within the past 2 weeks, or immunomodulatory therapeutic antibodies within the 5 half-lives or 30 days from randomization (whichever is longer), with the exception of hydroxychloroquine, chloroquine or corticosteroids at doses up to and including prednisolone 10mg daily or equivalent
<br>• Treatment with a prohibited drug within 5 half-lives or 30 days (whichever is longer) of randomization or during the course of the study
<br>•Serum alanine transaminase (ALT) or aspartate transaminase (AST) >5 times upper limit of normal detected within 24 hours at screening or at baseline or other evidence of severe hepatic impairment (Child-Pugh Class C)
<br>• Absolute peripheral blood neutrophil count of =1000/mm3
<br>• Estimated glomerular filtration rate (eGFR) =30 mL/min/1.73m2
<br><br> | COVID-19 pneumonia and impaired respiratory function <br>MedDRA version: 20.0
Level: LLT
Classification code 10061986
Term: SARS
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: DFV890<br>Product Code: DFV890<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Not yet established<br>Current Sponsor code: DFV890<br>Other descriptive name: IFM-2427<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 25-<br><br> | Timepoint(s) of evaluation of this end point: Day 15 or on day of discharge (whichever is earlier);Primary end point(s): Evaluate the effect of DFV890 in addition to SoC, compared with SoC alone on the Acute Physiology and Chronic Health Evaluation II (APACHE II) score;Secondary Objective: • To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on inflammatory status<br>• To evaluate the effect of DFV890 in addition to SoC, compared with SoC alone, on clinical status <br>• To evaluate the safety of DFV890 in addition to SoC, compared with SoC alone <br><br>;Main Objective: Evaluate the effect of DFV890 in addition to SoC, compared with SoC alone on the Acute Physiology and Chronic Health Evaluation II (APACHE II) score | | | | Yes | True | child | |
| → | EUCTR2020-003654-71-GR | 5 April 2021 | Study Assessing the Efficacy and Safety of Anti-Spike SARS CoV-2 Monoclonal Antibodies for Prevention of SARS CoV-2 Infection Asymptomatic in Healthy Adults and Adolescents Who Are Household Contacts to an Individual With a Positive SARS-CoV-2 RT-PCR Assay | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Assessing the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies in Preventing SARS-Cov-2 Infection in Household Contacts of Individuals Infected with SARS-CoV-2 | | Regeneron Pharmaceuticals, Inc. | 26/11/2020 | 20201126 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-003654-71 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 04/12/2020 | 2000 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Moldova, Republic of;Chile;Israel;Romania;Brazil;Greece;Mexico;United States | Clinical Trials information | | 777 Old Saw Mill River Road | clinicaltrials@regeneron.com | | Regeneron Pharmaceuticals, Inc. | Inclusion criteria: <br>1. Adult subjects 18 years of age (irrespective of weight) and above at the signing of informed consent or adolescent subjects =12 to <18 years of age (weight =40 kg) at the signing of the assent (parents sign the informed consent)<br>2. Asymptomatic household contact with exposure to an individual with a diagnosis of SARS-CoV-2 infection (index case). To be included in the study, subjects must be randomized within 96 hours of collection of the index cases’ positive SARS-COV-2 diagnostic test sample <br>3. Subject anticipates living in the same household with the index case until study day 29 <br>4. Is judged by the investigator to be in good health based on medical history and physical examination at screening/baseline, including subjects who are healthy or have a chronic, stable medical condition <br>5. Willing and able to comply with study visits and study-related procedures/assessments. <br>6. Provide informed consent signed by study subject or legally acceptable representative.<br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: 200<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 1400<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 400<br> | Exclusion criteria: <br>1. History of prior positive SARS-CoV-2 RT-PCR test or positive SARS-CoV-2 serology test at any time before the screening<br>2. Subject has lived with individuals who have had previous SARS-CoV-2 infection<br>3. Active respiratory or non-respiratory symptoms consistent with COVID-19<br>4. History of respiratory illness with sign/symptoms of SARS-CoV-2 infection, in the opinion<br>of the investigator within the prior month to screening<br>5. Nursing home resident<br>6. Any physical examination findings, and/or history of any illness, concomitant medications or recent live vaccines that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the subject by their participation in the study<br> | Coronavirus disease 2019 (COVID-19) <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Code: REGN10933<br>Pharmaceutical Form: Solution for injection/infusion<br>INN or Proposed INN: REGN10933<br>Current Sponsor code: REGN10933<br>Other descriptive name: REGN10933<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 120-<br>Pharmaceutical form of the placebo: Solution for injection/infusion<br>Route of administration of the placebo: Subcutaneous use<br><br>Product Code: REGN10987<br>Pharmaceutical Form: Solution for injection/infusion<br>INN or Proposed INN: REGN10987<br>Current Sponsor code: REGN10987<br>Other descriptive name: REGN10987<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 120-<br>Pharmaceutical form of the placebo: Solution for injection/infusion<br>Route of administration of the placebo: Subcutaneous use<br><br> | Main Objective: Primary Objective:<br>Cohort A (A): SARS-CoV-2 RT-qPCR Negative at Baseline: Objectives for Cohort A are for subjects who are seronegative at baseline (by central lab test) unless stated otherwise. <br>• To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (strict-term) confirmed by RT-qPCR<br><br>• To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing asymptomatic or symptomatic SARS-CoV-2 infection confirmed by RT-qPCR<br><br>• To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo<br><br>Cohort B (B): SARS-CoV-2 RT-qPCR Positive at Baseline: objectives for Cohort B are for all subjects irrespective of their serology status (positive or negative) at baseline (by central lab test): no primary objectives;Timepoint(s) of evaluation of this end point: 1. Up to 1 month <br>2. Up to 1 month <br>3. Up to 8 months;Primary end point(s): Cohort A (SARS-CoV-2 RT-qPCR Negative at Baseline); the endpoints are for subjects who are seronegative at baseline (based on central lab test) unless stated otherwise:<br>1.Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR (based on central lab test) and signs and symptoms (strict-term) of SARS-CoV-2 infection during the EAP <br>2.Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection (either asymptomatic or symptomatic) during the EAP<br>3.Proportion of subjects with TEAEs and severity of TEAEs.<br><br>Cohort B SARS-CoV-2 RT-qPCR Positive at Baseline; the endpoints are for all subjects irrespective of baseline serology status (based on central lab test): no primary endpoints;Secondary Objective: -Efficacy of REGN10933+REGN10987 vs placebo in preventing (broad-term/strict-term) symptomatic SARS-CoV2 (Cohort A,B)<br>-Efficacy of REGN10933+REGN10987 vs placebo in preventing asymptomatic SARS-CoV2 (Cohort A)<br>-Impact of REGN10933+REGN10987 vs placebo on duration of signs/symptoms in symptomatic SARS-CoV2 (Cohort A,B)<br>-Impact of REGN10933+REGN10987 vs placebo on SARS-CoV2 test results (Cohort A,B)<br>-Impact of REGN10933+REGN10987 vs placebo on SARS-CoV2 on health care utilization, absenteeism (Cohort A,B)<br>-Drug concentration-time profiles of REGN10933 and REGN10987 (Cohort A,B)<br>-Immunogenicity of REGN10933 and REGN10987 (Cohort A,B)<br>-Safety/tolerability of REGN10933+REGN10987 in sero+ subjects (Cohort A)<br>-Safety/tolerability of REGN10933+REGN10987 (Cohort B)<br>-Incidence/severity of symptomatic SARS-CoV2 over time in REGN10933+REGN10987-treated subjects: <br> -sero-/sero+ subjects vs placebo-treated (Cohort A)<br> -subjects vs placebo-treated subjects (Cohort B)→Timepoint(s) of evaluation of this end point: 1. Up to 1 month <br>2. Up to 1 month <br>3. Up to 8 months;Primary end point(s): Cohort A (SARS-CoV-2 RT-qPCR Negative at Baseline); the endpoints are for subjects who are seronegative at baseline (based on central lab test) unless stated otherwise:<br>1.Proportion of subjects who have a positive SARS-CoV-2 RT-qPCR (based on central lab test) and signs and symptoms (strict-term) of SARS-CoV-2 infection during the EAP <br>2.Proportion of subjects who have a RT-qPCR confirmed SARS-CoV-2 infection (either asymptomatic or symptomatic) during the EAP<br>3.Proportion of subjects with TEAEs and severity of TEAEs.<br><br>Cohort B SARS-CoV-2 RT-qPCR Positive at Baseline; the endpoints are for all subjects irrespective of baseline serology status (based on central lab test): no primary endpoints;Secondary Objective: -Efficacy of REGN10933+REGN10987 vs placebo in preventing (broad-term/strict-term) symptomatic SARS-CoV2 (Cohort A,B)<br>-Efficacy of REGN10933+REGN10987 vs placebo in preventing asymptomatic SARS-CoV2 (Cohort A)<br>-Impact of REGN10933+REGN10987 vs placebo on duration of signs/symptoms in symptomatic SARS-CoV2 (Cohort A,B)<br>-Impact of REGN10933+REGN10987 vs placebo on SARS-CoV2 test results (Cohort A,B)<br>-Impact of REGN10933+REGN10987 vs placebo on SARS-CoV2 on health care utilization, absenteeism (Cohort A,B)<br>-Drug concentration-time profiles of REGN10933 and REGN10987 (Cohort A,B)<br>-Immunogenicity of REGN10933 and REGN10987 (Cohort A,B)<br>-Safety/tolerability of REGN10933+REGN10987 in sero+ subjects (Cohort A)<br>-Safety/tolerability of REGN10933+REGN10987 (Cohort B)<br>-Incidence/severity of symptomatic SARS-CoV2 over time in REGN10933+REGN10987-treated subjects: <br> -sero-/sero+ subjects vs placebo-treated (Cohort A)<br> -subjects vs placebo-treated subjects (Cohort B);Main Objective: Primary Objective:<br>Cohort A (A): SARS-CoV-2 RT-qPCR Negative at Baseline: Objectives for Cohort A are for subjects who are seronegative at baseline (by central lab test) unless stated otherwise. <br>• To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing symptomatic SARS-CoV-2 infection (strict-term) confirmed by RT-qPCR<br><br>• To evaluate the efficacy of REGN10933+REGN10987 compared to placebo in preventing asymptomatic or symptomatic SARS-CoV-2 infection confirmed by RT-qPCR<br><br>• To evaluate the safety and tolerability of REGN10933+REGN10987 following subcutaneous (SC) administration compared to placebo<br><br>Cohort B (B): SARS-CoV-2 RT-qPCR Positive at Baseline: objectives for Cohort B are for all subjects irrespective of their serology status (positive or negative) at baseline (by central lab test): no primary objectives | | | | Yes | False | | |
| EUCTR2020-002913-16-BE | 5 April 2021 | The TRISTARDS trial - ThRombolysIS Therapy for ARDS A study to test whether different doses of alteplase help people with severe breathing problems because of COVID 19. | The TRISTARDS trial - ThRombolysIS Therapy for ARDS
A Phase IIb/III operationally seamless, open-label, randomised, sequential, parallel-group adaptive study to evaluate the efficacy and safety of daily intravenous alteplase treatment given up to 5 days on top of standard of care (SOC) compared with SOC alone, in patients with acute respiratory distress syndrome (ARDS) triggered by COVID-19. | | SCS Boehringer Ingelheim Comm. V | 05/11/2020 | 20201105 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002913-16 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 26/11/2020 | 270 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: standard of care<br>Number of treatment arms in the trial: 3<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Sweden;China;Netherlands;Germany;Denmark;Brazil;Belgium;France;Italy;United Kingdom;Russian Federation;Austria;Spain;Portugal | CT Disclosure & Data Transparency | | Binger Strasse 173 | clintriage.rdg@boehringer-ingelheim.com | 498002430127 | Boehringer Ingelheim Pharma GmbH & Co. KG | Inclusion criteria: <br>1. Age = 18 years (or above legal age, e.g. UK =16 years)<br>2. ARDS with PaO2*/FiO2 ratio >100 and =300 , either on non-invasive ventilator support, OR on mechanical ventilation (<48 hours since intubation), <br>• with bilateral opacities in chest X-ray or CT scan (not fully explained by effusions, lobar/lung collapse, or nodules)<br>• with respiratory failure (not fully explained by cardiac failure/fluid overload)<br>*or estimation of PaO2/FiO2 from pulse oximetry (SpO2/FiO2)<br>3. SARS-CoV-2 positive (laboratory-confirmed RT-PCR test) <br>4. Fibrinogen level = upper limit of normal <br>5. D-Dimer = 3-fold of upper limit of normal (ULN) according to local laboratory<br>6. Signed and dated written informed consent in accordance with ICH Good Clinical Practice (GCP) and local legislation prior to admission to the trial.<br><br><br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: 10<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 90<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 178<br> | Exclusion criteria: <br>1. Massive confirmed pulmonary embolism (PE) with haemodynamic instability at trial entry <br>2. Patients on mechanical ventilation for longer than 48 hours<br>3. Chronic pulmonary disease i.e. with known forced expiratory volume in 1 second (FEV1) <50% requiring home oxygen, or oral steroid therapy or hospitalisation for exacerbation within 12 months, or significant chronic pulmonary disease in the Investigator’s opinion, or primary pulmonary arterial hypertension<br>4. Has a Do-Not-Intubate (DNI) or Do-Not-Resuscitate (DNR) order<br>5. In the opinion of the investigator, is not expected to survive for <br>> 48 hours after admission<br>6. Patients with known hypersensitivity to the active substance alteplase, gentamicin (a trace residue from the manufacturing process) or to any of the excipients<br>7. Significant bleeding disorder at present or within the past 3 months, known haemorrhagic diathesis<br>8. Patients receiving effective oral anticoagulant treatment, e.g. vitamin K antagonists with INR >1.3, or any direct oral anticoagulant within the past 48 hours<br>9. Any history of central nervous system damage (i.e. neoplasm, aneurysm, intracranial or spinal surgery)<br>10. History or evidence or suspicion of intracranial haemorrhage including sub-arachnoid haemorrhage<br>11. Severe uncontrolled arterial hypertension (according to the investigator`s judgement)<br>12. Major surgery or significant trauma in the past 10 days, recent trauma to head or cranium<br>13. Cardiac arrest and/or cardiopulmonary resuscitation during the current hospital stay<br>14. Obstetrical delivery within the past 10 days<br>15. Severe hepatic dysfunction, including biopsy confirmed hepatic cirrhosis, portal hypertension, hepatic encephalopathy, or active hepatitis<br>16. Bacterial endocarditis, pericarditis<br>17. Acute pancreatitis<br>18. Documented ulcerative gastro-intestinal disease during the last 3 months<br>19. Severe heart failure (New York Heart Association Class IV)<br>20. Arterial aneurysms, arterial/venous malformations<br>21. Malignancy (Stage IV)<br>22. Haemorrhagic stroke or stroke of unknown origin at any time<br>23. Ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 months<br><br>Further criteria apply.<br><br> | Acute respiratory distress syndrome caused by Covid-19 <br>MedDRA version: 21.1
Level: PT
Classification code 10001052
Term: Acute respiratory distress syndrome
System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Alteplase Powder and Solvent for Solution for Injection/Infusion (TPA-05, 50 mg/vial)<br>Pharmaceutical Form: Powder and solvent for solution for injection/infusion<br>INN or Proposed INN: ALTEPLASE<br>CAS Number: 105857-23-6<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 1-<br><br> | Timepoint(s) of evaluation of this end point: 1) up to day 28;Primary end point(s): 1) Time to clinical improvement or hospital discharge up to Day 28, defined as the time from randomization to either an improvement of two points on the 11-point WHO Clinical Progression Scale or discharge from the hospital, whichever comes first. ;Secondary Objective: Not applicable;Main Objective: To evaluate the efficacy and safety of intravenous alteplase in ARDS triggered by COVID-19. | | | | Yes | True | parent | |
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| NCT04666233 | 12 April 2021 | Personal Protective Equipment for the Prevention of SARS-Cov-2 During Neonatal Resuscitation | Does Personal Protective Equipment for the Prevention of SARS-Cov-2 Infection Impact the Timing of Ventilation in Neonates Needing Resuscitation at Birth? A Crossover Randomized Controlled Trial | | University Hospital Padova | 11/12/2020 | 20201211 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04666233 | Not recruiting | No | N/A | N/A | All | March 16, 2021 | 48 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Italy | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Level III neonatal intensive care unit consultants, pediatric residents, and nurses.
<br> Participants will be divided into teams including a consultant and a nurse or a
<br> resident and a nurse during the simulation.
<br>
<br> Exclusion Criteria:
<br>
<br> - There are no exclusion criteria for this study.
<br> | | Neonates Needing Resuscitation at Birth | Procedure: Neonatal resuscitation with PPE for the prevention of SARS-Cov-2 infection;Procedure: Neonatal resuscitation without PPE for the prevention of SARS-Cov-2 infection | Initiation of positive pressure ventilation | | | | Yes | False | | |
| → | NCT04668339 | 12 April 2021 | A Trial Evaluating the Safety and Effects of an RNA Vaccine ARCT-021 in Healthy Adults | A Phase 2 Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety, Reactogenicity, and Immunogenicity of the SARS CoV-2 Vaccine ARCT-021 in Healthy Adult Participants | | Arcturus Therapeutics, Inc. | 25/11/2020 | 20201125 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04668339 | Not recruiting | No | 18 Years | N/A | All | January 7, 2021 | 600 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | United States;Singapore;United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> Individuals who:
<br>
<br> 1. are able to provide consent
<br>
<br> 2. agree to comply with all study visits and procedures
<br>
<br> 3. are willing and able to adhere to study restrictions
<br>
<br> 4. are sexually active and willing to adhere to contraceptive requirements
<br>
<br> 5. are male or female =18 or (in Singapore) =21 years of age
<br>
<br> 6. are medically stable
<br>
<br> Exclusion Criteria:
<br>
<br> Individuals who:
<br>
<br> 1. have had SARS-CoV-2 infection or COVID-19 disease.
<br>
<br> 2. have had cancer except for cancers that were treated and that have low risk of
<br> returning
<br>
<br> 3. have chronic kidney disease
<br>
<br> 4. have some chronic lung diseases
<br>
<br> 5. have some heart conditions
<br>
<br> 6. have compromised immune systems
<br>
<br> 7. are obese
<br>
<br> 8. have sickle cell disease or some other blood disorders
<br>
<br> 9. are current smokers and/or use illegal drugs
<br>
<br> 10. have Type 2 diabetics
<br>
<br> 11. are immunocompromised, immunodeficient or have had a transplant
<br>
<br> 12. have autoimmune disease
<br>
<br> 13. have other severe or uncontrolled diseases or disease that may interfere with the
<br> interpretation of the study
<br>
<br> 14. have a positive test for hepatitis B or C or human immunodeficiency virus
<br>
<br> 15. have had a severe reaction to previous investigational vaccines
<br>
<br> 16. have a fever or are feeling sick close to the time of the first vaccination of the
<br> study
<br>
<br> 17. have positive drug test at screening
<br>
<br> 18. are pregnant
<br>
<br> 19. are breastfeeding
<br>
<br> 20. have a bleeding disorder
<br>
<br> 21. have previously received an investigational coronavirus vaccine (SARS-CoV(1) or MERS)
<br> or who plan to be in other COVID-19 studies
<br>
<br> 22. have recently been vaccinated with other vaccines
<br>
<br> 23. have recently received blood products
<br>
<br> 24. who work at one of the clinic sites participating in this study, work at Arcturus, who
<br> work at other companies that monitor the study or close family members to the sites,
<br> Arcturus, or partners involved in study monitoring
<br>
<br> 25. other restrictions may apply
<br> | | Covid19;SARS-CoV Infection;Corona Virus Infection | Biological: ARCT-021 single dose priming;Biological: ARCT-021 two lower dose priming;Biological: ARCT-021 two higher dose priming;Biological: Placebo (two doses), priming;Biological: Randomized booster;Biological: Placebo booster | Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 serum neutralizing antibody levels;Changes in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point, expressed as GMFRs;SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs;Percentages of participants with abnormal chemistry and hematology values;Percentages of participants reporting new onset of chronic disease;Percentages of participants reporting medically attended adverse events;Percentages of participants reporting serious adverse events;Percentages of participants reporting adverse events;Percentages of participants reporting solicited systemic adverse events;Percentages of participants reporting solicited local adverse events→Percentages of participants reporting serious adverse events;Percentages of participants reporting medically attended adverse events;Percentages of participants reporting new onset of chronic disease;Percentages of participants with abnormal chemistry and hematology values;SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs;Changes in SARS-CoV-2 serum neutralizing titers from before vaccination to each subsequent time point, expressed as GMFRs;Percentages of participants achieving greater than or equal to 2-fold and 4-fold rises from before vaccination in SARS-CoV-2 serum neutralizing antibody levels;Percentages of participants reporting adverse events;Percentages of participants reporting solicited systemic adverse events;Percentages of participants reporting solicited local adverse events | | | | Yes | False | | |
| NCT04678739 | 12 April 2021 | Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial | Efficacy and Safety of Remdesivir and Tociluzumab for the Management of Severe COVID-19: A Randomized Controlled Trial | | M Abdur Rahim Medical College and Hospital | 19/12/2020 | 20201219 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04678739 | Not recruiting | No | 16 Years | 80 Years | All | August 15, 2020 | 205 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | Bangladesh | ; | Abu Taiub Mohammed Mohiuddin Chowdhury, MBBS, MD;Akter Kamal, MD, PhD | | ; | ; | First Affiliated Hospital Xi'an Jiaotong University;M Abdur Rahim Medical College Hospital |
<br> Inclusion Criteria:
<br>
<br> Severe COVID-19 patients require hospitalization under HDU/ICU. The SARS-CoV-2 infection
<br> will be confirmed by RT PCR / CT Chest in every case.
<br>
<br> Exclusion Criteria:
<br>
<br> - Participants with uncontrolled clinical status who were hospitalized from the before.
<br>
<br> - Contraindication / possible drug interaction.
<br>
<br> - Participants who have any severe and/or uncontrolled medical conditions like, Severe
<br> ischemic heart disease, epilepsy, malignancy, Pulmonary/renal/hepatic disease, AIDS,
<br> Pulmonary TB, pregnancy, Corpulmonale, and etc.
<br> | | Covid19;Covid-19 ARDS | Drug: Remdesivir;Drug: Tocilizumab | Time to Clinical Improvement (TTCI) | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04812184 | 12 April 2021 | Adhesive Tape Placement on Patients' Masks in the ED Increases Compliance of Proper Face Mask Use | Adhesive Tape Placement on Patients' Masks in the ED Increases Compliance of Proper Face Mask Use | | Indiana University | 17/03/2021 | 20210317 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04812184 | Not recruiting | No | 18 Years | N/A | All | April 1, 2020 | 123 | Interventional | Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - presenting to the emergency department during the covid-19 pandemic
<br>
<br> - older than 18 years of age
<br>
<br> Exclusion Criteria:
<br>
<br> - pregnant
<br>
<br> - prisoner
<br>
<br> - not english speaking
<br>
<br> - not intoxicated or decompensated psychiatric illness
<br>
<br> - not critically ill
<br>
<br> - not allergic to standard tape and/or tegaderm
<br> | | Covid19 | Device: Tape Face Mask | Proper face mask use up to 60 minutes | | | | No | False | | |
| → | NCT04812496 | 12 April 2021 | Tenofovir-DF Versus Hydroxychloroquine in the Treatment of Hospitalized Patients With COVID-19 (TEDHICOV) | Tenofovir-DF Versus Hydroxychloroquine in the Treatment of Hospitalized Patients With COVID-19: An Observational Study (TEDHICOV) | TEDHICOV | Hospital Nacional Carlos Alberto Seguin Escobedo - EsSalud | 19/03/2021 | 20210319 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04812496 | Not recruiting | No | 18 Years | N/A | All | March 1, 2020 | 100 | Observational | | | Peru | | Mario Cornejo-Giraldo, M.D. | | | | Head of the Infectious Diseases Unit |
<br> Inclusion Criteria:
<br>
<br> - Hospitalized adults over 18 years of age
<br>
<br> - Positive molecular test for SARS-CoV-2
<br>
<br> - Computed tomography (TC scan) compatible with "COVID pneumonia" and / or in need of
<br> supplemental oxygen
<br>
<br> - Therapy with Tenofovir-DF (TDF) or Hydroxychloroquine (HCQ) at least 3 days
<br>
<br> - Signed informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Negative molecular test for SARS-CoV-2
<br>
<br> - No need for hospitalization
<br>
<br> - Negative CT scan for "COVID pneumonia" and / or no supplemental oxygen requirement for
<br> COVID-19
<br>
<br> - Had not received either HCQ or TDF, or both drugs at the same time, or had received
<br> HCQ or TDF for two days or less
<br>
<br> - No signed informed consent
<br> | | Covid19;SARS-CoV Infection;Tenofovir | | Hospital stay;Mechanical Ventilation;Mortality within 30 days of hospital admission→Mortality within 30 days of hospital admission;Mechanical Ventilation;Hospital stay | | | | No | False | | |
| NCT04813471 | 12 April 2021 | Managing Endothelial Dysfunction in Critically Ill COVID-19 Patients at LAUMCRH | Managing Endothelial Dysfunction in Critically Ill COVID-19 Patients at the Lebanese American University Medical Center- Rizk Hospital | | Lebanese American University Medical Center | 22/03/2021 | 20210322 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04813471 | Recruiting | No | 18 Years | 99 Years | All | January 20, 2021 | 70 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | Lebanon | ; | Kamal Matli, MD;Georges Ghanem, MD | | matlikamal@gmail.com;georges.ghanem@laumcrh.com | +9613439675;9611200800 | |
<br> Inclusion Criteria:
<br>
<br> - Participants must be 18 years of age or older
<br>
<br> - Participants must have a PCR confirming COVID 19 status
<br>
<br> - Participants must be classified as critical as per the FDA evidence of critical
<br> illness, which is defined as respiratory failure requiring at least one of the
<br> following: Endotracheal intubation and mechanical ventilation, oxygen delivered by
<br> high- flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal
<br> cannula at flow rates > 20 L/min with fraction of delivered oxygen = 0.5), noninvasive
<br> positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure
<br> (i.e., clinical need for one of the preceding therapies, but preceding therapies not
<br> able to be administered in setting of resource limitation)
<br>
<br> - Eligible for or already taking Statin
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who are already on statins or Nicorandil.
<br>
<br> - Patients labeled as having mild, moderate or severe COVID-19 infection as per the FDA
<br> definitions.
<br>
<br> - Patients with shock as defined by SBP<90 for more than 30 minutes not responding to IV
<br> fluids with evidence of end organ damage.
<br>
<br> - Severe hepatic impairment (Child-Pugh class C) or active liver disease are absolute
<br> reasons not to be included especially those with unexplained persistent elevations of
<br> serum transaminases.
<br>
<br> - Pregnancy or breastfeeding
<br>
<br> - Hypersensitivity to any of the above-mentioned medications
<br>
<br> - On Levodopa.
<br>
<br> - Patients on PDE5 inhibitors, Riociguat
<br>
<br> - Acute pulmonary edema
<br>
<br> - Hypovolemia
<br>
<br> - Leber's disease
<br> | | Covid19;Endothelial Dysfunction | Drug: Endothelial Protocol | Clinical Improvement | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04816630 | 12 April 2021 | Feasibility Study of Hematology Parameters in COVID-19 Disease | Feasibility Study to Evaluate Performance of MDW and Other Hematology Parameters for Identification of COVID-19 Disease and Clinical Progression in Adult Hospitalized Patients - Washington University | | Beckman Coulter, Inc. | 15/03/2021 | 20210315 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04816630 | Recruiting | No | 18 Years | 89 Years | All | December 21, 2020 | 500 | Observational | | | United States | ; ; | Tiffany Osborn, MD;Diana B Careaga, MT;Kelly Bochicchio, MS, RN | | ;diana.careaga@beckman.com;kbochicchio@wustl.edu | ;305-803-1301;314-286-2965 | Washington University School of Medicine; |
<br> Inclusion Criteria:
<br>
<br> - Adult patients [18-89 years of age]
<br>
<br> - Present to the Emergency Department
<br>
<br> - With symptoms suggestive of COVID-19 or respiratory infection
<br>
<br> - Whose assessment includes CBC-Diff and RT-PCR testing
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnancy
<br>
<br> - Prisoners
<br>
<br> - <18 years of age
<br>
<br> - >89 years of age
<br>
<br> - Previously evaluated in this study
<br>
<br> - No RT-PCR testing
<br>
<br> - Sample age >2 hours from time of draw
<br>
<br> - Instrument flags, including vote outs and review flags for the MDW parameter
<br>
<br> - Samples stored in refrigerated temperatures
<br> | | Covid19;Sepsis;Adults;Emergency Department | Device: CBC-Diff Monocyte Volume Width Distribution | COVID-19 diseased patients | | | | No | False | | |
| → | NCT04816656 | 12 April 2021 | An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic | An Integrated Digital PROM-platform for Cancer Patients During the COVID-19 Pandemic | COVID-ONCO | Jessa Hospital | 24/03/2021 | 20210324 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04816656 | Not recruiting | No | 18 Years | N/A | All | August 3, 2020 | 43 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | Belgium | | Jeroen Mebis, MD, PhD | | | | Jessa Hospital |
<br> Inclusion Criteria:
<br>
<br> - Diagnosed with any type of cancer (except breast cancer)
<br>
<br> - Undergoing or starting chemotherapy with or without surgery
<br>
<br> - Age = 18 years
<br>
<br> - Access to the online application via computer or smartphone
<br>
<br> - Able to comply with the study protocol
<br>
<br> - Able to sign written informed consent in the digital AWELL platform
<br>
<br> - Provide a signed informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Diagnosed with breast cancer and undergoing chemotherapy (patients are already
<br> included in the healthcare path breast at Jessa Hospital)
<br>
<br> - Undergoing other therapies (e.g. immunotherapy, radiotherapy, targeted therapy,
<br> hormonal therapy)
<br>
<br> - Insufficient understanding of the Dutch language
<br>
<br> - Severe cognitive impairment
<br> | | Covid19;Oncology;PROMs;Chemotherapeutic Toxicity | Other: ePROMs assessment | Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);5-level EQ-5D version (EQ5D5L);5-level EQ-5D version (EQ5D5L);5-level EQ-5D version (EQ5D5L);5-level EQ-5D version (EQ5D5L);5-level EQ-5D version (EQ5D5L);5-level EQ-5D version (EQ5D5L);5-level EQ-5D version (EQ5D5L);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;5-level EQ-5D version (EQ5D5L);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Covid-19 triage questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);Patient satisfaction;Patient satisfaction;Patient satisfaction;Patient satisfaction;Patient satisfaction;Patient satisfaction;Patient satisfaction;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire→Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);5-level EQ-5D version (EQ5D5L);5-level EQ-5D version (EQ5D5L);5-level EQ-5D version (EQ5D5L);5-level EQ-5D version (EQ5D5L);5-level EQ-5D version (EQ5D5L);5-level EQ-5D version (EQ5D5L);5-level EQ-5D version (EQ5D5L);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Patient-Reported Outcomes-Common Terminology Criteria for Adverse Events (PRO-CTCAE);Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;5-level EQ-5D version (EQ5D5L);Covid-19 triage questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);COVID-19 Peritraumatic Distress Index (CPDI);Patient satisfaction;Patient satisfaction;Patient satisfaction;Patient satisfaction;Patient satisfaction;Patient satisfaction;Patient satisfaction;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;COVID-19 questionnaire;Covid-19 triage questionnaire;Covid-19 triage questionnaire | | | | No | False | | |
| NCT04816760 | 12 April 2021 | Immune Cells Phenotypes During COVID-19 | Alterations of Innate and Adaptive Immune Cells During the Course of SARS CoV-2 Pneumonia | IMMUNO-COVID | Institut Hospitalo-Universitaire Méditerranée Infection | 12/02/2021 | 20210212 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04816760 | Recruiting | No | 18 Years | N/A | All | March 25, 2020 | 100 | Observational | | | France | ; | Jean-Louis MEGE, MD, PhD;Line MEDDEB | | ;line.meddeb@ap-hm.fr | ;0413732347 | Institut Hospitalo-Universitaire Méditérranée Infection; |
<br> Inclusion Criteria:
<br>
<br> - Age > 18 y
<br>
<br> - Laboratory confirmed SARS CoV-2 infection (positive RT-PCR).
<br>
<br> - Ground-glass opacity on chest computed-tomography
<br>
<br> - Time from hospital admission to inclusion < or equal to 72 h
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnant
<br>
<br> - Under legal restriction
<br> | | Sars-CoV2;Innate Immunity;Immunization; Infection;Alveolar Lung Disease;Endothelial Dysfunction | Biological: Peripheral blood samples | Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.;Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.;Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.;Platelet activation and circulating microparticles assessment during SARS CoV-2 infection.;Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.;Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.;Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.;Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.;Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.;Serum IgA, IgM and IgG antibodies during SARS CoV-2 infection.;Functional state of innate and adaptive immune cells during SARS CoV-2 infection.;Functional state of innate and adaptive immune cells during SARS CoV-2 infection.;Functional state of innate and adaptive immune cells during SARS CoV-2 infection.;Functional state of innate and adaptive immune cells during SARS CoV-2 infection.;Functional state of innate and adaptive immune cells during SARS CoV-2 infection.;Functional state of innate and adaptive immune cells during SARS CoV-2 infection.;Profiling of innate and adaptive immune cells during SARS CoV-2 infection.;Profiling of innate and adaptive immune cells during SARS CoV-2 infection.;Profiling of innate and adaptive immune cells during SARS CoV-2 infection.;Profiling of innate and adaptive immune cells during SARS CoV-2 infection.;Profiling of innate and adaptive immune cells during SARS CoV-2 infection.;Profiling of innate and adaptive immune cells during SARS CoV-2 infection. | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04817657 | 12 April 2021 | Pre-approval Access for Janssen's COVID Vaccine VAC31518 for Treating Physician Use | COVID Vaccine VAC31518 Pre-approval Access Study | | Janssen Research & Development, LLC | 24/03/2021 | 20210324 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04817657 | Not recruiting | No | | | | April 7, 2021 | | Expanded Access | | | | | Janssen Research & Development, LLC Clinical Trial | | | | Janssen Research & Development, LLC | | | Healthy | Biological: Ad26.COV2.S | | | | | Yes | False | | |
| → | NCT04818697 | 12 April 2021 | Effect of Social Isolation on Physical Activity Level, and Kinesophobia in Heart Rhythm Disorders During Pandemic | Effect of Social Isolation on Physical Activity Level, Health Literacy and Kinesophobia in Heart Rhythm Disorders During the COVID-19 Pandemic | | Hacettepe University | 24/03/2021 | 20210324 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04818697 | Not recruiting | No | 18 Years | N/A | All | June 24, 2020 | 105 | Observational | | | Turkey | ; ; ; | Naciye Vardar-Yagli, PhD;Hikmet Yorgun, PhD MD;Ahmet Hakan Ates, PhD MD;Dilara Saklica, MsC | | ;;; | ;;; | Hacettepe University;Hacettepe University;Hacettepe University;Hacettepe University |
<br> Inclusion Criteria:
<br>
<br> - Having been diagnosed with heart rhythm disorders
<br>
<br> - Being clinically stable
<br>
<br> - To comply with social isolation rules
<br>
<br> - Volunteering to participate in the research
<br>
<br> Exclusion Criteria:
<br>
<br> - Having a cognitive problem
<br>
<br> - Not being literate
<br> | | Heart Rhythm Disorder;Covid19;Social Isolation | | Fear of Movement;Physical Activity Level→Physical Activity Level;Fear of Movement | | | | No | False | | |
| NCT04819165 | 12 April 2021 | Healthcare-associated Infections in Severe COVID-19 During 2020 | Healthcare-associated Infections in Severe COVID-19 Patients Whit Mechanical Ventilation During 2020 | COVIACS | Sanatorio Anchorena San Martin | 25/03/2021 | 20210325 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04819165 | Not recruiting | No | 18 Years | N/A | All | March 1, 2020 | 252 | Observational | | | Argentina | | matias accoce | | | | SAnchorena San Martin |
<br> Inclusion Criteria:
<br>
<br> - All patients older than 18 years admitted to the intensive care unit of the Anchorena
<br> San Martín Clinic who required invasive mechanical ventilation for more than 24 hours
<br> in a period between March 2020 and December 2020 were included in the analysis.
<br>
<br> Exclusion Criteria:
<br>
<br> - All patients who presented incomplete data in the follow-up sheets were excluded.
<br> | | Respiration, Artificial;COVID-19;Health Care Associated Infection | Other: COVID-19 | Incidence of health care associated infections in each group. | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04827160 | 12 April 2021 | Prediction of Thrombosis Using D-dimer Trends in COVID-19 | Predictive Value of D-dimers Trends and Levels for Thrombosis in Patients With COVID-19 | TRENDS | Central Hospital, Nancy, France | 30/03/2021 | 20210330 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04827160 | Not recruiting | No | 18 Years | N/A | All | March 2, 2020 | 280 | Observational | | | France | | | | | | |
<br> Inclusion Criteria: Positive SARS-CoV-2 PCR and at least one D-dimer result
<br>
<br> Non inclusion Criteria: Below 18 yo
<br> | | Covid19 | | D-dimer trends | | | | No | False | | |
| → | NCT04828148 | 12 April 2021 | Incidence of Infection and Mortality by COVID-19 in Specialists | Incidence of Infection and Mortality by COVID-19 in Specialists in Mexico: A Cross-sectional Study | | Instituto Mexicano del Seguro Social | 30/03/2021 | 20210330 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04828148 | Recruiting | No | 18 Years | N/A | All | March 1, 2021 | 400 | Observational | | | Mexico | | Alejandro González Ojeda, PhD | | avygail5@gmail.com | 3336683000 | |
<br> Inclusion Criteria:
<br>
<br> - Active physicians and medical students who have had contact with patients infected by
<br> COVID-19
<br>
<br> - Active physicians and medical students who have been infected by COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> - Members of the general population
<br>
<br> - Inactive physicians or medical students
<br>
<br> - Incomplete surveys
<br> | | Covid19;Health Care Associated Infection;Infection, Coronavirus;Death | Behavioral: Survey | Incidence of infection in physicians due to COVID-19;Incidence of mortality in physicians due to COVID-19→Incidence of mortality in physicians due to COVID-19;Incidence of infection in physicians due to COVID-19 | | | | Yes | False | | |
| NCT04828564 | 12 April 2021 | Efficacy and Safety of Favipiravir and Ribavirin Formulation for Treatment of COVID-19 | An Open-Label, Multicenter, Parallel-Group, Randomized, Phase II/III Study to Evaluate the Efficacy and Safety of Favipiravir and Ribavirin Formulation for Treatment of COVID-19 | COVID-19 | The Scientific and Technological Research Council of Turkey | 01/04/2021 | 20210401 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04828564 | Not recruiting | No | 18 Years | N/A | All | April 2021 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2/Phase 3 | Turkey | | Alpay Azap, MD, Prof | | azap@medicine.ankara.edu.tr | +90 312 508 2681 | |
<br> Inclusion Criteria:
<br>
<br> - Female or male patients aged 18 years and older infected with the SARS-CoV-2 virus.
<br>
<br> - Patients that have COVID-19 symptoms within 72 hours and have a positive PCR test
<br> result.
<br>
<br> - Patients in a stable clinical condition and referred as outpatient for COVID-19
<br> infection.
<br>
<br> - Patients who sign the informed consent before the any study procedures.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who have required hospitalization.
<br>
<br> - Patients who have required intensive care.
<br>
<br> - Patients who do not sign the informed consent.
<br>
<br> - Any condition that in the investigator's judgement might interfere with study
<br> procedures or the ability of the patient to adhere to and complete the study.
<br>
<br> - Patients who have been participating in any other clinical trial.
<br>
<br> - Severe liver failure (Child Pugh score = C, transaminase>5 times the upper limit of
<br> normal (ULN).
<br>
<br> - Severe renal failure (GFR =30 mL/min/1.73 m2) or continuous dialysis (hemodialysis,
<br> peritoneal dialysis) or continuous renal replacement therapy.
<br>
<br> - Severe cardiac disease.
<br>
<br> - History of hypersensitivity to either ribavirin/favipiravir.
<br>
<br> - Pregnant or breast-feeding.
<br>
<br> - Patients who cannot use appropriate contraceptive method during and after the study.
<br>
<br> - Patients who are treated with any other treatment agent for COVID-19 in the last 90
<br> days.
<br>
<br> - Patients who had COVID-19 vaccination.
<br>
<br> - Patients who had ribavirin/favipiravir for any reason in the past 72 hours.
<br> | | SARS-CoV2;COVID-19 | Drug: Ribavirin Capsules;Drug: Favipiravir | Hospitalized patient rates | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| ISRCTN17846723 | 12 April 2021 | A web-based referral service to facilitate rapid and direct access to mental health care for youth | A web-based referral service to facilitate rapid and direct access to mental health care: Protocol for a mixed-methods, multiple-case, feasibility study of PRISM-AOM (Pathway for Rapid, Internet-based Self-referral to Mental Health Services for Youth - ACCESS Open Minds) | | Centre Hospitalier de l’Université de Montréal | 16/03/2021 | 20210316 | ISRCTN | http://isrctn.com/ISRCTN17846723 | Recruiting | No | | | Both | 16/03/2021 | 180 | Interventional | Mixed-methods convergent QUAN-QUAL multiple-case study methodology, including exploratory analyses based on a quasi-experimental interrupted time-series design (Other) | Not Applicable | Canada | | | | | | | Inclusion criteria: <br> 1. The referral form can be completed by any young person between the ages of 11 to 25 years; and, any individual that is 16 years of age and older can refer a young person in the role of third-party referrer (e.g., community worker, family member). The referral management system can be used by a service provider, service coordinator or clinical lead, or clinical-administrative staff at the implementation site.<br> 2. The stakeholder participants of focus groups, individual interviews, and document reviews can be any individual that participates in the development or implementation of the web-based referral service and is 18 years of age and above.<br> | Exclusion criteria: <br> 1. Youth aged under 11 years and adults aged over 25 years for the self-referral form users<br> 2. Youth aged under 16 years for the third-party referral form users<br> 3. Stakeholder participants involved in the development or implementation of the service will be excluded from focus groups and individual interviews if they are aged under 18 years or research staff or researchers<br> | Web-based referral to mental health services for youth <br>Mental and Behavioural Disorders | <br> The web-based referral service consists of three integrated technical components: 1) a landing page/website, 2) a dynamic online referral form, and 3) a referral management system, through which referrals can be received, manually created, triaged, sent, and tracked.<br><br> The first component of the web-based referral service is the landing page and related social marketing tools, which are designed to raise awareness about the existence and purpose of the referral service, and to provide a central location to host the links to the referral form.<br><br> The second component of the referral service is a referral form, which is designed to: empower a young person to refer themselves directly to a youth mental health team in their community at a time that is convenient for them, using their phone, computer, or tablet. The referral form also includes an option that allows a third-party referrer (e.g., family member, community worker, physician, school counsellor or nurse) to refer a young person to mental health services. In this project, youth and third-party referrers are referred to as ‘users of the referral form.’<br><br> The third component of the referral service is the referral management system, which is designed to support site teams (service providers, coordinators, site leads, clinical-administrative staff) in triaging and tracking referrals, which can be especially helpful within the context of higher demands for mental health services (e.g., COVID-19, physical distancing). Members of the site teams are referred to as ‘users of the referral management system.’<br> | <br> Demand, assessed by:<br> 1. Total number of referrals, organized by referral method, referral source, referral time, and sociodemographic information, at both sites on a monthly basis before (i.e., 24 months) and after implementation of the web-based referral service (i.e., during the study period, 12 to 15 months). Data will be extracted from the referral management system, clinical-research reports, or site level administrative and medical records<br> 2. The use of the referral management system by each of the site teams (e.g., number of logins per user) on a monthly basis during the study period (i.e., 12 to 15 months)<br> | | 31/03/2023 | | Yes | False | | |
| → | ISRCTN78284710 | 12 April 2021 | Clinical characteristics and outcomes of patients with COVID-19 on mechanical ventilation in Argentina | Clinical characteristics and outcomes of patients with COVID-19 on mechanical ventilation in Argentina: a prospective, multicenter cohort study | | Sociedad Argentina de Terapia Intensiva (SATI) | 03/03/2021 | 20210303 | ISRCTN | http://isrctn.com/ISRCTN78284710 | Not Recruiting | No | | | Both | 30/03/2020 | 1300 | Observational | Prospective cohort study (Treatment) | Not Applicable | Argentina | Elisa;Fernando→Fernando;Elisa | Estenssoro;Rios | Street 42 number 577;Marcos paz 684 | estenssoro.elisa@gmail.com;fernandrios@gmail.com | +54 (0)22196073261;+54 (0)1133796777 | ; | Inclusion criteria: Consecutive adult patients admitted to participating ICUs who require mechanical ventilation and present confirmed COVID-19 | Exclusion criteria: Patients with severe respiratory infections/pneumonia due to another proven etiology | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | Epidemiological data, comorbidities, previous signs or symptoms of COVID-19 are collected. On admission, severity of disease scores, laboratory management data, blood gases and acid-base chemistry, respiratory and mechanical ventilation management, and complications (development of ARDS, septic shock, acute kidney injury, thromboembolic events, infections and septic shock) will be recorded. If patients die, the cause of death will be recorded. Treatments administered by attending physicians will be registered. Dates of hospital and ICU admission, of death and/or discharge will be recorded. No intervention will be administered. Follow-up will continue until death or ICU/hospital discharge. | Hospital mortality: death of a patient (categorical binary data, 1 = nonsurvivor; and 0 = survivor) occurring at any time and in any site during hospitalization | | 10/01/2021 | | No | False | | |
| ISRCTN17354061 | 12 April 2021 | A pan-pandemic respiratory infection surveillance study | Avon Community-Acquired Pneumonia (AvonCAP) study: a pan-pandemic acute lower respiratory tract disease surveillance study | | University of Bristol | 03/03/2021 | 20210303 | ISRCTN | http://isrctn.com/ISRCTN17354061 | Recruiting | No | | | Both | 01/08/2020 | 60000 | Observational | Observational epidemiological study (Screening) | Not Applicable | United Kingdom | Jennifer | Oliver |
Population Health Sciences
Bristol Medical School
University of Bristol
Level 6
UH Bristol Education and Research Centre
Upper Maudlin | jennifer.oliver@bristol.ac.uk | +44 (0)1173310127 | | Inclusion criteria: <br> 1. Aged =18 years of age<br> 2. Patients with illness with the following two characteristics:<br> 2.1. Acute illness (i.e., present for 28 days or less) AND<br> 2.2. Evidence of acute LRTD:<br> 2.2.1. Patients with current or suspected COVID-19 or previous proven COVID-19 within last 28 days OR<br> 2.2.2. Clinical or radiologic diagnosis of pneumonia or an acute LRTI OR<br> 2.2.3. New onset or worsening of =2 of the following eight LRTD symptoms or clinical findings:<br> 2.2.3.1. Fever (>38.0°C) or hypothermia (<35.5°C) before or within 24 hours of enrolment<br> 2.2.3.2. Pleuritic chest pain<br> 2.2.3.3. Cough (including nocturnal only)<br> 2.2.3.4. Sputum production or purulence<br> 2.2.3.5. Dyspnea (shortness of breath) including orthopnea or on exertion only<br> 2.2.3.6. Tachypnea (respiratory rate =20/min) documented by healthcare professional<br> 2.2.3.7. Abnormal auscultatory findings suggestive of LRTD (e.g., crepitations/rales or evidence of pulmonary consolidation including dullness on percussion, bronchial breath sounds, wheezing, or egophony)<br> 2.2.3.8. Radiologic finding that is consistent with LRTD, including pneumonia, and/or acute congestive heart failure (e.g., pleural effusion, increased pulmonary density due to infection, the presence of alveolar infiltrates [multilobar, lobar or segmental] containing air bronchograms, or interstitial oedema)<br> | Exclusion criteria: <br> Patients meeting any of the following criteria will not be included in the study:<br> 1. Any patient who develops signs and symptoms of LRTD after being hospitalized for =48 hours (either at current hospital, another transferring hospital, or a combination of these), unless admitted with current, previous proven, or suspected COVID-19 infection.<br> 2. Previously enrolled participants readmitted =7 days after discharge for their study qualifying admission, unless admitted with current, previous proven, or suspected COVID-19 infection<br> 3. At the time of enrolment, an LRTD-related diagnosis has been excluded or another diagnosis confirmed (for example, patient was found to have fever and tachypnoea due to an intraabdominal process such as cholecystitis)<br> | Acute lower respiratory tract disease (LRTD) - which encompasses pneumonia, lower respiratory tract infection (LRTI), acute bronchitis, exacerbation of underlying respiratory disease including asthma and chronic obstructive pulmonary disease (COPD), as well as COVID-19 (SARS-CoV-2 infection) <br>Respiratory <br>Pneumonia, organism unspecified, Unspecified acute lower respiratory infection, Acute bronchitis, Asthma, Chronic obstructive pulmonary disease, unspecified | Adults with LRTD will be screened using population-level surveillance at study hospitals, and the collection of standard-of-care data will be performed on all LRTD events. Patients presenting during the recruitment period of the study, with documented or suspected COVID-19 will fulfil study eligibility criteria, and therefore all references to LRTD also encompass documented or suspected COVID-19 cases who may not otherwise qualify as LRTD. LRTD patients will be offered participation in the enhanced diagnostic testing portion of this study with informed consent, which will involve the collection of urine, respiratory, and in some cases blood samples, for additional testing, if necessary, for COVID-19, pneumococcus, and RSV as well as administration of a short patient questionnaire on COVID-related risk behaviours. The pneumococcal testing will include serotype to allow estimation of the proportion of the burden that is potentially vaccine-preventable – either by the currently available PCV13 or the anticipated PCV20, which is currently in the final phases of clinical development. Information about the additional pneumococcal, SARS-CoV-2 and RSV infection testing will be integrated with the population-level surveillance data to allow for more accurate population-based estimates of vaccine-preventable pneumococcal and COVID-19 and RSV-related LRTD incidence. The epidemiologic data generated from the study may serve as the baseline for future vaccine effectiveness studies | The population-based incidence of community-acquired LRTI hospitalizations during and following the COVID-19 pandemic, overall and for community-acquired pneumonia, obtained from the medical admission records within participating hospitals and analysed yearly for 3 years, with interim analyses carried out as required | | 31/10/2023 | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04405986 | 19 April 2021 | Exploring Brain Damages After COVID-19 Infection | Exploring Brain Damages After COVID-19 Infection | BRAINCOV | University Hospital, Bordeaux | 08/05/2020 | 20200508 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04405986 | Not recruiting | No | 18 Years | N/A | All | May 19, 2020 | 38 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label). | N/A | France | | Bertrand Glize | | | | bertrand.glize@chu-bordeaux.fr |
<br> Inclusion Criteria :
<br>
<br> - Age = 18 years.
<br>
<br> - Hospitalized patient suffering from a positive COVID 19 diagnosed by Reverse
<br> transcription polymerase chain reaction (RT-PCR) or chest computed tomography scan
<br> (CTscan) with specific lesions
<br>
<br> Exclusion Criteria :
<br>
<br> - History of neurological damage interfering with auditory evoked potentials (PEA) and
<br> Electromyography (EMG) reflexes of the brainstem (stroke of the brainstem, acoustic
<br> neuroma, amyotrophic lateral sclerosis, facial diplegia, damage to nerves V or VII,
<br> etc.)
<br>
<br> - Impaired alertness
<br>
<br> - Sedative treatments or treatments that disturb nerve conduction.
<br>
<br> - Pregnancy or breastfeeding
<br>
<br> - Individuals under legal protection or unable to express personally their consent
<br> | | SARS-CoV 2 | Procedure: Auditory Evoked Potentials (AEP);Procedure: Blink and Masseter Inhibitory Reflex | Inhibition rate;Duration of silent period;Delay of silent period;Delay of Muscle contraction;Latency of electrophysiological response | | | | Yes | False | | |
| → | NCT04415060 | 19 April 2021 | SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival | SedAting With Volatile Anesthetics Critically Ill COVID-19 Patients in ICU: Effects On Ventilatory Parameters And Survival. Multicentre Open-label, Pragmatic, Randomized Controlled Trial and a Parallel Prospective (Non-randomized) Cohort Study | SAVE-ICU | Sunnybrook Health Sciences Centre | 02/06/2020 | 20200602 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04415060 | Recruiting | No | 18 Years | N/A | All | June 15, 2020 | 752 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | Canada | | Angela Jerath, MD | | angela.jerath@sunnybrook.ca | 416.480.6100 | |
<br> Inclusion Criteria:
<br>
<br> 1. = 18 years of age;
<br>
<br> 2. Mechanically ventilated and expected to remain mechanically ventilated at the end of
<br> the next day;
<br>
<br> 3. Receiving IV sedation by infusion or bolus for =72 hours to facilitate mechanical
<br> ventilation. Transferred patients with escalating ventilation needs are eligible for
<br> recruitment within =72 hours of sedation commenced within the participating trial site
<br> that they were transferred to. Note: Intravenous sedation required to support
<br> mechanical ventilation includes use of one or more of the following agents:
<br> benzodiazepines, propofol, ketamine, barbiturates, alpha-2 agonist, opioids. Patients
<br> receiving intravenous opioids only i.e., fentanyl = 50mcg/hour, hydromorphone =
<br> 0.4mg/hour (or bolus q1h) for analgesia and sedation or agitation to assist mechanical
<br> ventilation are eligible for inclusion.
<br>
<br> 4. a) Proven or suspected (under investigation) COVID-19, or b) COVID-19 negative
<br> patients who have a PaO2FiO2 ratio =300 measured with arterial blood gas at least once
<br> during the 12 hours prior to enrollment.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Contraindications to sedatives, such as propofol infusion syndrome or malignant
<br> hyperthermia;
<br>
<br> 2. Known allergy to any of the ingredients or components of the investigational products;
<br> sevoflurane or isoflurane;
<br>
<br> 3. Suspect or evidence of high intracranial pressure;
<br>
<br> 4. Severe brain injury that is likely to lead to sustained very low conscious levels or
<br> vegetative state;
<br>
<br> 5. Severe neuromuscular disorder for example amyotrophic lateral sclerosis, Gullian Barre
<br> Syndrome that are the primary cause of needing ICU admission and mechanical
<br> ventilation;
<br>
<br> 6. One-lung ventilation or pneumonectomy;
<br>
<br> 7. Ideal estimated tidal volume too low for delivery of inhaled agents. Target (6ml/kg) <
<br> 200ml;
<br>
<br> 8. Use of inhaled prostacyclin which is contraindicated in the presence of a miniature
<br> vaporizer (i.e., Anesthesia Conserving Device). This agent has a high viscosity that
<br> leads to poor vaporization of the volatile agent. Note: Other inhaled pulmonary
<br> vasodilators such as nitric oxide can be safely administered in the presence of
<br> miniature vaporizers. Use of prostacyclin is permissible with an anesthesia machine
<br> and MADM;
<br>
<br> 9. Known pregnancy
<br>
<br> 10. Moribund patient not expected to survive >12 hours
<br> | | Covid19;Hypoxic Respiratory Failure | Drug: Isoflurane Inhalant Product;Drug: Sevoflurane inhalant product | Participant Quality of Life at 3 and 12 months after discharge;ICU-Free Days;Ventilator-Free Days;Hospital Mortality→Hospital Mortality;Ventilator-Free Days;ICU-Free Days;Participant Quality of Life at 3 and 12 months after discharge | | | | Yes | False | | |
| NCT04428021 | 19 April 2021 | Standard or Convalescent Plasma in Patients With Recent Onset of COVID-19 Respiratory Failure | Effectiveness of Adding Standard Plasma or COVID-19 Convalescent Plasma to Standard Treatment, Versus Standard Treatment Alone, in Patients With Recent Onset of COVID-19 Respiratory Failure. A Randomized, Three-arms, Phase 2 Trial | PLACO-COVID | Azienda Ospedaliera Città della Salute e della Scienza di Torino | 07/06/2020 | 20200607 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04428021 | Not recruiting | No | 18 Years | N/A | All | June 15, 2020 | 180 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor). | Phase 2 | Italy | | Paola Maria Manzini, MD | | | | AO Città della salute e della scienza di Torino |
<br> Inclusion Criteria:
<br>
<br> - Confirmed SARS-Cov-2 diagnosis by RT-PCR on nasopharyngeal swab or on bronchoalveolar
<br> lavage
<br>
<br> - Respiratory failure onset or progression within 5 days
<br>
<br> - Signed Informed Consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnancy
<br>
<br> - Previous severe reactions to plasma transfusion
<br>
<br> - Unavailability of blood group compatible COVID-19 convalescent plasma
<br> | | COVID-19 | Drug: Standard Therapy Protocol (STP);Other: STP + Standard Plasma (SP);Other: STP + COVID-19 Convalescent Plasma (CP) | 30-days survival | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04479644 | 19 April 2021 | Safety, Tolerability, and Pharmacokinetics Study of Human Monoclonal Antibody BRII-198 | A Phase 1 Randomized, Single-blind, Placebo-controlled, Single Ascending Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Human Monoclonal Antibody, BRII-198 Administered Intravenously to Healthy Adult Volunteers | | Brii Biosciences Limited | 14/07/2020 | 20200714 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04479644 | Not recruiting | No | 18 Years | 49 Years | All | July 13, 2020 | 17 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). | Phase 1 | China | | Yao Zhang | | | | TSB Therapeutics (Beijing) CO.LTD |
<br> Inclusion Criteria:
<br>
<br> - Subject must be 18 to 49 years of age inclusive;
<br>
<br> - Body weight =100 kg and body mass index (BMI) within the range of 19.0-24.0kg/m2
<br> (inclusive);
<br>
<br> - Male or female;
<br>
<br> Exclusion Criteria:
<br>
<br> - Any clinically significant chronic or acute medical condition that makes the volunteer
<br> unsuitable for participation;
<br>
<br> - A history of significant hypersensitivity, intolerance, or allergy to any drug
<br> compound;
<br>
<br> - History of alcohol or other substance abuse;
<br> | | COVID-19 | Drug: BRII-198;Drug: Placebo | Incidence of adverse events (AEs) by CTCAE v5.0;Proportion of subjects with SAEs;Proportion of subjects with infusion-related reactions;Proportion of subjects with hypersensitivity reactions | | | | Yes | False | | |
| → | NCT04488796 | 19 April 2021 | STAND UP to SARS-CoV-2 (COVID-19): Using Behavioural Economics to Reduce Sedentary Behaviour in At-home Office Workers | STAND UP to SARS-CoV-2 (COVID-19): Using Behavioural Economics to Reduce Sedentary Behaviour in At-home Office Workers, a Pilot Randomized Controlled Trial | | Western University, Canada | 22/07/2020 | 20200722 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04488796 | Not recruiting | No | 18 Years | N/A | All | September 7, 2020 | 148 | Interventional | Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | Canada | | Marc Mitchell, PhD | | | | Western University |
<br> Inclusion Criteria:
<br>
<br> - 18 years or older
<br>
<br> - Self-declare working 5 days per week (Monday to Friday)
<br>
<br> - Full-time worker/employee (i.e. employed = 30 hours/week)
<br>
<br> - Desk-based office worker currently only working from home
<br>
<br> - Have access to a computer with Internet and email
<br>
<br> - Able to read and write in English
<br>
<br> Exclusion Criteria:
<br>
<br> - Self-declared medical condition or physical limitation that prevents them from being
<br> physically active
<br>
<br> - Planning on leaving the current employer or taking a leave of absence for more than 3
<br> consecutive workdays for the duration of the study
<br> | | Health Behaviour Change | Behavioral: Assigned Strategies: Opt-in;Behavioral: Assigned Strategies: Active Choice;Behavioral: Assigned Strategies: Enhanced Active Choice;Behavioral: Choice of Assignment: Opt-in;Behavioral: Choice of Assignment: Active Choice;Behavioral: Choice of Assignment: Enhanced Active Choice | Change in sedentary behaviour break frequency;Change in sedentary behaviour break duration→Change in sedentary behaviour break duration;Change in sedentary behaviour break frequency | | | | Yes | False | | |
| NCT04494893 | 19 April 2021 | ImmuneRACE - Immune Response Action to COVID-19 Events | ImmuneRACE - Immune Response Action to COVID-19 Events | | Adaptive Biotechnologies | 29/07/2020 | 20200729 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04494893 | Not recruiting | No | 18 Years | 89 Years | All | April 24, 2020 | 808 | Observational | | | United States | | | | | | |
<br> Cohort 1. Exposed to coronavirus disease
<br>
<br> Inclusion criteria
<br>
<br> Participants must satisfy the following criteria to be enrolled in the study:
<br>
<br> Individuals exposed to someone with a confirmed diagnosis of coronavirus disease within 2
<br> weeks of exposure (or at the discretion of the investigator) Male and female participants
<br> of any race and ethnicity between 18 to 89 years of age (inclusive) at the time of
<br> enrolling in the study Must be able to communicate with the investigator, understand and
<br> comply with the requirements of the study
<br>
<br> Exclusion Criteria
<br>
<br> The presence of any of the following will exclude a participant from enrollment:
<br>
<br> Individuals who have not been exposed to a person with a confirmed diagnosis of coronavirus
<br> disease within 2 weeks of exposure (or at the discretion of the investigator) Protected
<br> populations including minors, pregnant women, prisoners, mentally disabled persons, and
<br> wards-of-the state Any significant condition, laboratory abnormality, or psychiatric
<br> illness that would prevent the participant from safely participating in the study Donated
<br> more than 500cc or 1 pint of blood in the past 60 days prior to the blood draw (at the
<br> discretion of the investigator)
<br>
<br> Cohort 2. Active coronavirus disease Inclusion criteria
<br>
<br> Participants must satisfy the following criteria to be enrolled in the study:
<br>
<br> Individuals with a diagnosis of coronavirus disease:
<br>
<br> Either by clinical diagnosis made by a medical professional, or By positive laboratory
<br> test, including but not limited to naso- or oropharyngeal swab (or at the discretion of the
<br> investigator) Male and female participants of any race and ethnicity between 18 to 89 years
<br> of age (inclusive) at the time of enrolling in the study Must be able to communicate with
<br> the investigator, understand and comply with the requirements of the study
<br>
<br> Exclusion Criteria
<br>
<br> The presence of any of the following will exclude a participant from enrollment:
<br>
<br> Individuals without a diagnosis of coronavirus disease Protected populations including
<br> minors, pregnant women, prisoners, mentally disabled persons, and wards-of-the state Any
<br> significant condition, laboratory abnormality, or psychiatric illness that would prevent
<br> the participant from safely participating in the study Donated more than 500cc or 1 pint of
<br> blood in the past 60 days prior to the blood draw (at the discretion of the investigator)
<br>
<br> Cohort 3. Recovered from coronavirus disease Inclusion criteria
<br>
<br> Participants must satisfy the following criteria to be enrolled in the study:
<br>
<br> Individuals previously diagnosed with coronavirus disease and cleared from active infection
<br> by:
<br>
<br> Testing negative on two consecutive naso- or oropharyngeal swab tests following initial
<br> diagnosis, or Cleared by a healthcare professional or public health authority, or
<br> Resolution of symptoms related to COVID-19 (or at the discretion of the investigator) Male
<br> and female participants of any race and ethnicity between 18 to 89 years of age (inclusive)
<br> at the time of enrolling in the study Must be able to communicate with the investigator,
<br> understand and comply with the requirements of the study
<br>
<br> Exclusion Criteria
<br>
<br> The presence of any of the following will exclude a participant from enrollment:
<br>
<br> Individuals without a previous diagnosis of coronavirus disease at the discretion of the
<br> investigator Protected populations including minors, pregnant women, prisoners, mentally
<br> disabled persons, and wards-of-the state Any significant condition, laboratory abnormality,
<br> or psychiatric illness that would prevent the participant from safely participating in the
<br> study Donated more than 500cc or 1 pint of blood in the past 60 days prior to the blood
<br> draw (at the discretion of the investigator)
<br> | | Covid19 | | Determine whether an immune signature can be detected in individuals exposed to SARS-CoV-2 earlier than currently available tests;Risk Stratification based on an individual's immune signature;Identify the immunodominant antigens that elicit a T-cell response to COVID-19;Comparison of disease-specific TCR signatures in patients and controls | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04556513 | 19 April 2021 | Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status | Functional Recovery From Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19: Influence of Socio-Economic Status | RECOVIDS | Centre Hospitalier Universitaire Dijon | 16/09/2020 | 20200916 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04556513 | Recruiting | No | 18 Years | N/A | All | September 18, 2020 | 500 | Observational | | | France | ; | Jean-Pierre QUENOT;Jean-Pierre QUENOT | | jean-pierre.quenot@chu-dijon.fr;jean-pierre.quenot@chu-dijon.fr | 0380293685;0380293685 | |
<br> Inclusion Criteria:
<br>
<br> - Inpatient in ICU for PCR-proven SARS-VOC-2 infection regardless of specimen type
<br>
<br> - Patient who received a chest CT scan in the initial phase of management (either just
<br> before or during hospitalization in the intensive care unit)
<br>
<br> - Patient who has received invasive or non-invasive ventilatory support, or humidified
<br> and heated high-flow oxygen (HFO).
<br>
<br> - ARDS meeting the criteria of the 2012 Berlin definition. For patients who have
<br> received only HFO, a flow rate at least equal to 50L/minute with a FiO2 strictly
<br> greater than 50% with a PaO2/FiO2 ratio less than or equal to 200 will be required for
<br> inclusion.
<br>
<br> - Patient who gave oral consent after being informed about the conduct of this study.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient with limited autonomy prior to hospitalization in limited intensive care unit:
<br> walking distance of less than 50 meters, WHO classification status 3 and 4.
<br>
<br> - Patient with a history of chronic respiratory failure as defined by the use of
<br> long-term oxygen therapy or non-invasive home ventilation, excluding patients with SAS
<br> and/or hypoventilation obesity syndrome.
<br>
<br> - Patient with a history of central or peripheral neurological conditions limiting the
<br> patient's motor autonomy and the performance on gait tests or Pulmonary function Tests
<br>
<br> - Patient refusing to participate
<br>
<br> - Patient < 18 years of age
<br>
<br> - Patient not affiliated or not benefiting from national health insurance
<br>
<br> - Patient under guardianship, curatorship or protected adult
<br>
<br> - Patient unable to understand and consent to the research protocol
<br>
<br> SECONDARY EXCLUSION CRITERIA
<br>
<br> - Patient not showing up for visit at M6
<br>
<br> - Patients who have not had all the examinations necessary to evaluate the main endpoint
<br> (Spirometry, DLCO, TM6 and CT)
<br> | | Covid19;ARDS;Functional Recovery | Other: Paraclinical examination;Other: Clinical Examination;Other: Semi-directive interview;Other: quality of life questionnaires | Respiratory sequelae 6 months after resuscitation. | | | | Yes | False | | |
| → | NCT04563702 | 19 April 2021 | Safety and Immunogenicity Trial of an Oral SARS-CoV-2 Vaccine (VXA-CoV2-1) for Prevention of COVID-19 in Healthy Adults | A Phase 1 Open-Label, Dose-Ranging Trial to Determine the Safety and Immunogenicity of an Adenoviral-Vector Based Vaccine (VXA-CoV2-1) Expressing a SARS-CoV-2 Antigen and dsRNA Adjuvant Administered Orally to Healthy Adult Volunteers | | Vaxart | 21/09/2020 | 20200921 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04563702 | Not recruiting | No | 18 Years | 54 Years | All | September 21, 2020 | 35 | Interventional | Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1 | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female between the ages of 18 to 54 years, inclusive.
<br>
<br> 2. Negative for SARS-CoV-2 infection at the time of screening
<br>
<br> 3. In generally good health, without significant medical illness
<br>
<br> 4. Demonstrates comprehension of the protocol procedures and is able to provide written
<br> informed consent.
<br>
<br> 5. Available for all planned visits and willing to complete all protocol defined
<br> procedures and assessments
<br>
<br> 6. Body mass index between 17 and 30 kg/m2 at screening.
<br>
<br> 7. Female subjects must have a negative pregnancy test at screening and before each
<br> vaccination and fulfill an acceptable method of birth control (per protocol)
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Known previous exposure to SARS-CoV-2 or receipt of an investigational product for the
<br> prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or
<br> severe acute respiratory syndrome (SARS).
<br>
<br> 2. Is in a current occupation with high risk of exposure to SARS-CoV-2
<br>
<br> 3. Individuals with the following underlying medical conditions who are at higher risk
<br> (or might be at higher risk) of severe illness from COVID-19 per the CDC's guidance
<br>
<br> 4. Donation or use of blood or blood products within 4 weeks prior to vaccination or
<br> planned donation during the study period.
<br>
<br> 5. Diagnosed bleeding disorder or significant bruising or bleeding difficulties that
<br> could make blood draws problematic.
<br>
<br> 6. Any condition that resulted in the absence or removal of the spleen.
<br>
<br> 7. Positive HIV, HBsAg or HCV tests at the screening visit.
<br>
<br> 8. Stool sample with occult blood at screening.
<br>
<br> 9. Use of antiviral medications, including anti-retrovirals, or any prescriptive
<br> medications for the prevention of COVID-19 within 7 days before vaccination
<br>
<br> 10. Use of antibiotics, proton pump inhibitors, H2 blockers or antacids or medications
<br> known to affect the immune function within 7 to 14 days before vaccination
<br>
<br> 11. Regular use of nonsteroidal anti-inflammatory drugs, sulfonylureas, and angiotensin II
<br> blockers within 7 days before vaccination
<br>
<br> 12. Acute disease within 72 hours prior to vaccination defined as the presence of a
<br> moderate or severe illness
<br>
<br> 13. History of drug, alcohol or chemical abuse within 1 year of screening or positive
<br> urine drug screen for drugs of abuse at screening
<br>
<br> 14. History of hypersensitivity or allergic reaction to any component of the
<br> investigational vaccine
<br>
<br> 15. Administration of any investigational vaccine, drug or device within 8 weeks preceding
<br> vaccination
<br>
<br> 16. Any other condition that in the clinical judgment of the investigator would jeopardize
<br> the safety or rights of a subject participating in the trial, would render the subject
<br> unable to comply with the protocol or would interfere with the evaluation of the study
<br> endpoints.
<br> | | Covid19 | Biological: VXA-CoV2-1 | Frequency of medically-attended adverse events (MAAEs);Frequency of serious adverse events (SAEs);Grade of unsolicited adverse events;Frequency of unsolicited adverse events;Grade of solicited symptoms of reactogenicity;Frequency of solicited symptoms of reactogenicity→Frequency of solicited symptoms of reactogenicity;Grade of solicited symptoms of reactogenicity;Frequency of unsolicited adverse events;Grade of unsolicited adverse events;Frequency of serious adverse events (SAEs);Frequency of medically-attended adverse events (MAAEs) | | | | Yes | False | | |
| NCT04573764 | 19 April 2021 | Acute Effects of Oral Ketone Ester on Cardiac Function in Patients With COVID-19 | Acute Effects of Oral Ketone Ester on Cardiac Function in Patients With COVID-19 | KetoCOVID | Steno Diabetes Center Copenhagen | 01/10/2020 | 20201001 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04573764 | Recruiting | No | 18 Years | N/A | All | February 1, 2021 | 12 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | N/A | Denmark | ; ; | Tor Biering-Sørensen, MD;Jens Christian Laursen, MD;Jens C Laursen, MD | | ;jens.christian.laursen.01@regionh.dk;jens.christian.laursen.01@reigonh.dk | ;30913252;004530913252 | University of Copenhagen; |
<br> Inclusion Criteria:
<br>
<br> - Patients previously hospitalized at hospitals of greater Copenhagen and the Zealand
<br> region with a laboratory confirmed diagnosis of COVID-19 > 18 years of age.
<br>
<br> Exclusion Criteria:
<br>
<br> - Persons not able to cooperate
<br>
<br> - Persons unable to understand and sign "informed consent"
<br>
<br> - Diagnosis with chronic obstructive pulmonary disease
<br>
<br> - Diagnosis with asthma
<br>
<br> - Active treatment with sodium-glucose transporter 2 inhibitors
<br>
<br> - eGFR < 15 ml/min/1.73m2
<br>
<br> - insulin-dependent diabetes
<br> | | COVID-19 | Dietary Supplement: D-beta-hydroxybutyrate-(R)-1,3 butanediol monoester;Dietary Supplement: Placebo | Left Ventricular ejection fraction | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04716907 | 26 April 2021 | Thymic Function in Patients With COVID-19 | Thymic Function in Patients With COVID-19 | COVITHYM | CMC Ambroise Paré | 16/01/2021 | 20210116 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04716907 | Recruiting | No | 18 Years | N/A | All | March 19, 2021 | 100 | Observational | | | France | ; | Rémi Cheynier, PhD;Pierre Squara, MD | | remi.cheynier@inserm.fr;pierre.squara@clinique-a-pare.fr | 0140516541;0146415079 | |
<br> Inclusion Criteria:
<br>
<br> Cases :
<br>
<br> - Patients with confirmed COVID-19 infection
<br>
<br> - Hospitalized for COVID-19 infection
<br>
<br> - Having signed a written informed consent form
<br>
<br> - Affiliation to the social security system
<br>
<br> Controls :
<br>
<br> - Non-COVID-19 patients
<br>
<br> - Hospitalized for other reasons
<br>
<br> - Age and sex-matched controls
<br>
<br> - Having signed a written informed consent form,
<br>
<br> - Affiliation to the social security system
<br>
<br> Exclusion Criteria:
<br>
<br> - Autoimmune disease
<br>
<br> - HIV, Hepatitis B or Hepatitis C
<br>
<br> - Pregnant or breastfeeding women
<br>
<br> - A mental or linguistic inability to understand the study
<br>
<br> - Patient under protection of the adults (guardianship, curators or safeguard of
<br> justice)
<br> | | Covid19 | Genetic: Single-Nucleotide Polymorphisms (SNP) within the TCRA/D region;Biological: Blood sample;Diagnostic Test: CT Scan;Biological: Bronchial fibroscopy | Genetic Predisposition to severe forms of COVID-19 | | | | Yes | False | | |
| → | NCT04737161 | 26 April 2021 | Safety of T Regulatory Cell Therapy in Subjects With COVID-19 Induced Acute Respiratory Distress Syndrome | A Phase 1 Study to Assess the Safety of Living Related Donor Derived T Regulatory Cell Therapy in Subjects With COVID 19 Induced Acute Respiratory Distress Syndrome (ARDS) | | Stanford University | 01/02/2021 | 20210201 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04737161 | Not recruiting | No | 18 Years | 75 Years | All | March 2021 | 0 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | United States | | Joe L Hsu, MD | | | | Stanford University |
<br> Inclusion Criteria:
<br>
<br> - Age 18 years to 75 years
<br>
<br> - All patients at entry are required to be at high risk for the development of ARDS or
<br> receiving mechanical ventilatory support
<br>
<br> - Provision of signed written informed consent from the patient or patients legally
<br> authorized representative
<br>
<br> - Only patients who are committed to full life support (Do not resuscitate (DNR)
<br> allowed)
<br>
<br> - Initiation of study drug within 120 hours of the diagnosis of acute lung injury
<br> (ALI)/ARDS
<br>
<br> - COVID positive by PCR testing
<br>
<br> Exclusion Criteria:
<br>
<br> - Concurrent illness that shortens life expectancy to less than 6 months
<br>
<br> - Inability to obtain adequate study follow-up
<br>
<br> - Greater than 90 hours since first meeting ARDS criteria per the Berlin definition
<br> | | Acute Respiratory Distress Syndrome;Covid19 | Biological: T regulatory cells | The number of patients who receive the target dose for one or more intravenous infusions;The number of patients that experience treatment emergent AEs;The number of participants that experience the occurrence of infusion associated adverse events (AEs)→The number of participants that experience the occurrence of infusion associated adverse events (AEs);The number of patients that experience treatment emergent AEs;The number of patients who receive the target dose for one or more intravenous infusions | | | | Yes | False | | |
| NCT04751474 | 26 April 2021 | The Effect of Motivational Messages on Optimism, Hopelessness and Life Satisfaction | The Effect of Motivational Messages on Optimism, Hopelessness and Life Satisfaction of Intensive Care Nurses During the COVID-19 Pandemic : A Randomized Controlled Study | | Saglik Bilimleri Universitesi | 08/02/2021 | 20210208 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04751474 | Not recruiting | No | 18 Years | N/A | All | February 1, 2021 | 93 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: None (Open Label). | N/A | Turkey | | Elif Gezginci, RN, PhD | | | | Saglik Bilimleri Universitesi |
<br> Inclusion Criteria:
<br>
<br> - agreeing to participate in the study
<br>
<br> - being a nurse
<br>
<br> - working in intensive care during the COVID-19 pandemic
<br>
<br> Exclusion Criteria:
<br>
<br> - underfilling or not fill out forms and scales
<br> | | Motivation;Optimism;Hopelessness;Life Satisfaction | Other: Motivational messages | Life satisfaction assessed by the Satisfaction with Life Scale;Hopelessness level assessed by the Beck Hopelessness Scale;Optimistic level assessed by the Life Orientation Test | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2021-000365-33-NL | 26 April 2021 | Viral clearance, PK and tolerability of ensovibep in COVID-19 patients | A Phase 2a open label, non-comparative, single dose escalation study to evaluate the dynamics of viral clearance, pharmacokinetics and tolerability of ensovibep in patients with symptomatic COVID-19 disease | | Molecular Partners AG | 02/03/2021 | 20210302 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000365-33 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 17/03/2021 | 40 | Interventional clinical trial of medicinal product | Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Netherlands | Principal Investigator | | Zernikedreef 8 | clintrials@chdr.nl | +31715246400 | Centre for Human Drug Research | Inclusion criteria: <br>1. Men or non-pregnant women, between 18 and 70 years on the day of inclusion.<br>2. Presence of one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat, malaise, fatigue, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion.<br>3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test).<br>4. Female subjects must agree to use highly effective contraception as described in section 4.5.1 or must be of non-childbearing potential. A woman is considered to be of non-childbearing potential if she meets one of the following criteria:<br>a. be post-menopausal (spontaneous amenorrhea for at least 12 months,); or<br>b. has no uterus, ovaries or fallopian tubes.<br>5. Agree to follow the contraception requirements of the trial as described in section 4.5.1.<br>6. Understand and agree to comply with planned study procedures, including nasopharyngeal swabs and venous blood samples.<br>7. Able to communicate well with the investigator in the Dutch language and has provided signed informed consent.<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 39<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 1<br> | Exclusion criteria: <br>1. Requiring hospitalization at time of screening, or at time of study drug administration.<br>2. Oxygen saturation (SpO2) = 93 percent (%) on room air at sea level, respiratory rate = 30 per minute, or heart rate =125 per minute.<br>3. Known allergies to any of the components used in the i.v. formulation of ensovibep.<br>4. Any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study.<br>5. Any co-morbidity requiring hospitalization or surgery within <7 days, or that is considered life-threatening within 29 days.<br>6. A patient reported history (prior to the current episode) of a positive SARS-CoV-2 serology test or a history of PCR confirmed SARS-CoV-2 infection.<br>7. Prior or concurrent use of SARS-CoV-2 antiviral medication, including convalescent serum or anti-viral antibodies.<br>8. Concurrent enrollment in any other type of medical research for improving COVID-19 outcomes or that is judged by the investigator not to be scientifically or medically compatible with this study.<br>9. Women that are currently breast feeding, pregnant, or plan to get pregnant during the duration of the trial.<br>10. Severe immunocompromised status (primary immunodeficiency, supraphysiological dose of systemic corticosteroids, transplant patients, known untreated HIV and CD4 T-cells <200/microliter) or use of any immunosuppressants that, in the opinion of the investigator, should preclude participation in this study.<br>11. Subjects at high risk for of COVID-19 related complications or mortality, defined as:<br>a. Age 50 to 70 years and at least one of the following other risk factors: <br>i. BMI >35 kg/m2<br>ii. Chronic Cardiac or pulmonary disease (e.g. atrial fibrillation, CAD, heart failure, COPD, asthma), that might pose additional risks in study participation, as per investigator decision<br>iii. Ongoing clinically significant neurological disease (e.g. stroke or any other chronic debilitating neurological disease)<br>iv. Chronic kidney disease with GFR <60 ml/min, as per medical history<br>v. Rheumatic disease (e.g. rheumatoid arthritis, Systemic lupus erythematosus, psoriatic arthritis) <br>vi. Cancer not in complete remission for >1 year (excluding baso -or spinocellular skin cancers) <br>vii. Chronic liver disease (liver cirrhosis Child Pugh A/B/C or other disease leading to liver dysfunction) as per medical history<br>b. Age < 50 years with 3 or more of the above-mentioned risk factors.<br><br> | SARS-CoV-2 infection (COVID-19) <br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Ensovibep<br>Product Code: MP0420<br>Pharmaceutical Form: Solution for infusion<br>INN or Proposed INN: Ensovibep<br>Current Sponsor code: MP0420<br>Other descriptive name: DARPin targeting three different epitopes of SARS-CoV-2 receptor-binding domain<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 15-<br><br>Product Name: Ensovibep<br>Product Code: MP0420<br>Pharmaceutical Form: Solution for infusion<br>INN or Proposed INN: Ensovibep<br>Current Sponsor code: MP0420<br>Other descriptive name: DARPin targeting three different epitopes of SARS-CoV-2 receptor-binding domain<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 15-<br><br> | Timepoint(s) of evaluation of this end point: Day 1 - FFU;Primary end point(s): • Changes from baseline to each time point of measurement in viral load (quantitative PCR) and viral cultures, as per assessment schedule <br>• Duration in days to PCR negativity<br>• Measurement of ensovibep in serum and assess PK paramenters (including Cmax, T1/2, Tmax, AUCinf, AUClast, CL, Vss)<br>;Secondary Objective: • To observe the evolution of clinical symptoms for COVID-19 following ensovibep administration<br>• To characterize the tolerability of two single i.v. flat dose levels of ensovibep in patients with symptomatic COVID-19 disease<br>;Main Objective: • To characterize the dynamics of viral clearance (incl. viral cultures, qPCR) following ensovibep administration <br>• To evaluate the serum pharmacokinetics of single, i.v. doses of ensovibep in patients with symptomatic COVID-19 disease<br> | | | | Yes | True | parent | |
| → | EUCTR2020-006075-15-NL | 26 April 2021 | An infusion of antibodies to COVID-19 for patients with B cell disorder, a randomized (randomized) study (COVID Compromise study). | Convalescent Antibody-Mediated Treatment of COVID-19 Infections in Patients with B-cell dysfunction, a Randomized Trial.
- COVID-Compromise Study | | Amsterdam UMC | 19/03/2021 | 20210319 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-006075-15 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 25/03/2021 | 86 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: no
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Netherlands | dr. J. Heijmans | | Meibergdreef 9 | j.heijmans@amsterdamumc.nl | | Amsterdam UMC | Inclusion criteria: <br>• Patient is = 18 years of age, diagnosed with COVID-19 based on a positive PCR or antigen test. <br>• Hospitalized.<br>AND one of immunocompromised conditions/treatments below<br> B-cell inhibition related ICP<br>• Use of anti-CD19 or -CD20 directed antibody therapy in 6 months prior to inclusion.<br>• Previous or current treatment with drugs that significantly impair B cell function (e.g. ibrutinib, venetoclax, acalabrutinib, idelalisib etc) within 6 months prior to inclusion<br>Other immunosuppression/treatment related ICP<br>• Patients treated with bendamustine, purine analogues or anti-thymocyte globulin within 6 months prior to inclusion. <br>• Solid organ transplant patients that are taking systemic immunosuppressive drugs from at least three pharmacological classes. <br>Cellular therapy related ICP<br>• Allogeneic hematopoietic stem cell transplant (HSCT) in 12 months prior to inclusion.<br>• HSCT for which systemic therapy against graft-versus-host-disease is used.<br>• Recipient of CAR-T cells < 2 years prior to inclusion.<br>Disease related ICP<br>• Chronic B-cell leukemia´s: CLL, HCL, PLL, multiple myeloma, Waldenströms macroglobulinemia<br>Congenital ICP<br>• Congenital disorder resulting in severe B-cell dysfunction or depletion requiring immunoglobulin suppletion (e.g. agammaglobulinemia). <br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 43<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 43<br> | Exclusion criteria: <br>• Has previously participated in this study.<br>• Has previously received convalescent plasma with high level neutralizing anti-SARS-CoV-2 antibodies (either in other study or in compassionate use program). <br>• Known hypersensitivity to treatment with immunoglobulins (WHO grade 3-4). <br>• Patient who has reached endpoint already at admission (direct adjunctive oxygen therapy in the form of high-flow nasal oxygen (HFNO), mechanical ventilation or ICU admission for other reason). <br><br> | COVID-19 disease due to an infection with SARS-CoV2-virus;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Nanogam<br>Product Name: Nanogam <br>Pharmaceutical Form: Solution for infusion<br><br>Trade Name: Nanogam<br>Product Name: Nanogam<br>Pharmaceutical Form: Solution for infusion<br><br> | Timepoint(s) of evaluation of this end point: Day 1, 2, 3, 7, 10, 21, 28 and month 3, 6, 12;Main Objective: To generate proof that convalescent antibody-mediated treatment of ICPs, who suffer from COVID-19 disease can protect ICPs from a more severe course of disease.;Primary end point(s): • Start of adjunctive ventilator support (HFNO, mechanical ventilation) or an indication to do so but due to due to previously agreed treatment restrictions HFNO or mechanical ventilation is not initiated.<br>• Admission to an intensive care unit for progression of respiratory insufficiency.<br>• No clinical improvement on day 7 after randomization or any day thereafter after first day of treatment (based on oxygen use in patients that require oxygen and based on clinical disease burden (including fever) in patients that require no oxygen). <br>• Readmission for COVID-19. <br>;Secondary Objective: • To evaluate the impact of convalescent antibody-mediated treatment on duration of hospitalization in the ICP population.<br>• To evaluate the impact of convalescent antibody-mediated treatment on mortality in the ICP population. <br>• To evaluate the impact of convalescent antibody-mediated treatment on ICU admission in the ICP population. <br>• To evaluate the impact of convalescent antibody-mediated treatment on symptom duration in the ICP population. <br>• To evaluate the impact of convalescent antibody-mediated treatment on viral clearance in the ICP population.<br>→Timepoint(s) of evaluation of this end point: Day 1, 2, 3, 7, 10, 21, 28 and month 3, 6, 12;Primary end point(s): • Start of adjunctive ventilator support (HFNO, mechanical ventilation) or an indication to do so but due to due to previously agreed treatment restrictions HFNO or mechanical ventilation is not initiated.<br>• Admission to an intensive care unit for progression of respiratory insufficiency.<br>• No clinical improvement on day 7 after randomization or any day thereafter after first day of treatment (based on oxygen use in patients that require oxygen and based on clinical disease burden (including fever) in patients that require no oxygen). <br>• Readmission for COVID-19. <br>;Secondary Objective: • To evaluate the impact of convalescent antibody-mediated treatment on duration of hospitalization in the ICP population.<br>• To evaluate the impact of convalescent antibody-mediated treatment on mortality in the ICP population. <br>• To evaluate the impact of convalescent antibody-mediated treatment on ICU admission in the ICP population. <br>• To evaluate the impact of convalescent antibody-mediated treatment on symptom duration in the ICP population. <br>• To evaluate the impact of convalescent antibody-mediated treatment on viral clearance in the ICP population.<br>;Main Objective: To generate proof that convalescent antibody-mediated treatment of ICPs, who suffer from COVID-19 disease can protect ICPs from a more severe course of disease. | | | | Yes | False | | |
| EUCTR2021-000701-24-NL | 26 April 2021 | Switching of COVID-19 Vaccines: a solution for the problems? | Switching of COVID-19 Vaccines: a solution for the problems? - SWITCH | | Erasmus MC | 22/03/2021 | 20210322 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000701-24 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 31/03/2021 | 600 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: The comparator receive two identical vaccinations according to the label
Number of treatment arms in the trial: 3
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Netherlands | Hugo van der Kuy | | dr. Molewaterplein 40 | h.vanderkuy@erasmusmc.nl | 0031628586702 | Erasmus MC | Inclusion criteria: <br>All HCW who work in the health care facility with at least one confirmed SARS CoV-2 infected patient receiving care and who have symptoms associated with SARS CoV-2. <br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 600<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range 0<br> | Exclusion criteria: <br>1. HCW younger than 18<br>2. HCW that are pregnant or have a wish to become pregnant within 6 months<br>3. All regular contra-indications of the vaccines will be applied<br><br> | Health Care Workers of the Erasmus Medical Centre will be vaccinated with Covid-19 vaccinations. They will either receive two the same vaccines or two different after which immune response will be measured;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Trade Name: Comirnaty concentraat voor dispersie voor injectie<br>Pharmaceutical Form: Dispersion for injection<br><br>Trade Name: COVID-19 vaccine Moderna, dispersie voor injectie<br>Pharmaceutical Form: Dispersion for injection<br><br>Trade Name: COVID-19 Vaccine AstraZeneca, suspensie voor injectie<br>Pharmaceutical Form: Suspension for injection<br><br> | Main Objective: to measure the immune response against SARS-CoV-2 after two different vaccinations in Health Care Workers (HCW) (intervention group). This will be compared with HCW that will receive two boosts from the same vaccines (control group).;Timepoint(s) of evaluation of this end point: At baseline and after SARS-CoV-2 vaccination, which will be performed according to standard of care, blood will be drawn at in 5 different time points, i.e. baseline (before 1st vaccination), at day of 2nd vaccination, and 28 days, and 6 and 12 months after 2nd vaccination.;Primary end point(s): Detection of immunity against SARS-CoV-2;Secondary Objective: 1. To assess adverse events after SARS-CoV-2 vaccination. <br>2. To evaluate development of antibody and cellular response after 1st vaccination<br>3. To assess durability of the antibody response<br>4. To analyze the SARS-CoV-2-specific T and B cell response after vaccination<br> | | | | Yes | False | | |
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| EUCTR2021-000440-22-BE | 26 April 2021 | Vaccination against COVID-19 in Pregnant and Lactating Women in Belgium | Vaccination against COVID-19 in Pregnant and Lactating Women in Belgium - PREGCOVAC.BE | | Universiteit Antwerpen | 25/02/2021 | 20210225 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000440-22 | Authorised | No | | | <br>Female: yes<br>Male: no<br> | 25/03/2021 | 420 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: no intervention
Number of treatment arms in the trial: 3
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Belgium | Investigator | | Universiteitsplein 1 | kirsten.maertens@uantwerpen.be | 003232652862 | Universiteit Antwerpen | Inclusion criteria: <br>• Female population older than 18 years.<br>• Ability to provide informed consent.<br>• Being vaccinated with a COVID-19 vaccine.<br>• Intend to be available for follow-up visits through one year<br>postvaccination.<br>• Influenza and pertussis vaccination during pregnancy (as per Belgian<br>recommendations) is allowed.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 420<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>Serious underlying immunological condition (e.g. immunosuppressive<br>disease or therapy, human immunodeficiency virus (HIV) infection…).<br>• Systemic treatment with immune suppressive medication, including<br>chronic steroid use of > 10 mg prednisone or equivalent.<br>• Anything in the opinion of the investigator that would prevent<br>volunteers from completing the study or put the volunteer at risk.<br> | Vaccine responses to COVID19 vaccines administered in pregnant and
lactating women;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Comirnaty<br>Product Name: Comirnaty<br>Product Code: J07BX03<br>Pharmaceutical Form: Injection<br><br>Trade Name: Covid-19 Vaccine Moderna<br>Product Name: Covid19 Vaccine Moderna<br>Product Code: J07BX03<br>Pharmaceutical Form: Injection<br><br>Trade Name: COVID19 Vaccine Astrazeneca<br>Product Name: Covid 19 Vaccine AstraZeneca<br>Product Code: J07BX03<br>Pharmaceutical Form: Injection<br><br> | Main Objective: The one central question is whether pregnant and lactating women can<br>develop similar protective immunity against COVID-19 upon vaccination,<br>without safety issues. This question needs to be answered urgently and<br>would help the health care workers and in a later stage the general<br>population to decide whether immunization in pregnancy or in the<br>postpartum period during lactation is safe and effective.;Secondary Objective: In this project we will compare vaccination in pregnant women with age<br>matched non-pregnant women (from the PICOVAC study, see appendix)<br>and women vaccinated in the postpartum period during lactation. The<br>primary objectives are to assess the immune response and safety after<br>administration of COVID-19 mRNA Vaccine BNT162b2<br>(Comirnaty®;Pfizer-BioNTech), or other vaccines against COVID19<br>whenever available for administration in our region, in a population of<br>pregnant women (N=120), age-matched non-pregnant women (120) and postpartum lactating women<br>(N=100+ 120), also controlled with an existing prospective study group.;Primary end point(s): To investigate the antibody based immune response (ELISA RBD<br>antibodies (IgG) ) on day 28 after the second vaccination in pregnant<br>women, age matched control non-pregnant women and postpartum<br>lactating women. The definition of response will be based on a<br>serological correlate of protection for COVID-19 based on SARS-CoV-2<br>spike(S)-protein specific serum IgG antibody levels (in IU/mL or<br>seroconversion (a=4-fold increase of the geometric mean concentration<br>(GMC) of anti-S protein IgG antibodies over baseline)). For those with a<br>previous COVID infection, the in house multiplex assay from Sciensano<br>will be performed to discriminate between previous infection and<br>vaccination;Timepoint(s) of evaluation of this end point: 28 days | | | | Yes | False | | |
| → | EUCTR2021-001665-20-HU | 26 April 2021 | Efficacy of nebulized 4.2% sodium-bicarbonate in COVID-19 pneumonia | Prospective, randomized, controlled, double-blinded study on the efficacy of nebulized 4.2% sodium-bicarbonate in COVID-19 pneumonia | | Semmelweis University Department of Oralbiology | 26/03/2021 | 20210326 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-001665-20 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 20/04/2021 | 200 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Hungary | Department of Oralbiology | | Nagyvárad tér 4. | zsembery.akos@dent.semmelweis-univ.hu | | Semmelweis University | Inclusion criteria: <br>- antigen or PCR test verified COVID-19 pneumonia <br>- age: 18-64 yrs<br>- informed consent <br>- CT-verified bilateral GGO > 50% (CORADS 6)<br>- invasive ventillation within 48hrs <br>- PaO2/FiO2 <200 (at PEEP > 5 H2O cm)<br>- serum prokalcitonin < 0.5 ng/ml <br>- serum ferritin > 500 ng/ml<br>- 20 < BMI <45<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 200<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>- hypernatremia<br>- metabolic alkalosis<br>- relevant concomitant disease (excluding well-controlled hypertension)<br>- renal failure: se creatinin > 200 µM (on adequate volume tehrapy) <br>- liver failure (se bilirubin > 34 µM) <br>- hematologic disease<br>- chronic immune and/or hemopoetic disease<br>- bacterial infection (evaluated as serum prokalcitonin szint > 0.5 ng/ml, purulent sputum, unilateral pulmonary consolidation)<br><br> | severe COVID-19 pneumonia requires invasive ventillatory support <br>MedDRA version: 23.1
Level: LLT
Classification code 10084564
Term: SARS-CoV-2 pneumonia
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Natrium-hydrogen-carbonicum Pharmamagist 42 mg/ml oldatos injekció<br>Pharmaceutical Form: Solution for injection/infusion<br>Pharmaceutical form of the placebo: Inhalation solution<br>Route of administration of the placebo: Inhalation use<br><br> | Timepoint(s) of evaluation of this end point: the change in PaO2/FiO2 (Horowitz index): at day 7<br>the number of Ventillator Free Days (VFD): at day 28<br>;Primary end point(s): - the change in PaO2/FiO2 (Horowitz index) <br>- the number of Ventillator Free Days (VFD) in an interval of 28 days<br>;Secondary Objective: To assess the effect of nebulized 4.2% sodium bicarbonate on the clinical and inflammatory status of ventillated patients with COVID-19 pneumonia<br>To assess the safety of nebulized 4.2% sodium bicarbonate in ventillated patients with COVID-19 pneumonia;Main Objective: To assess the effect of nebulized 4.2% sodium bicarbonate on the oxygenization of ventillated patients with COVID-19 pneumonia→Main Objective: To assess the effect of nebulized 4.2% sodium bicarbonate on the oxygenization of ventillated patients with COVID-19 pneumonia;Secondary Objective: To assess the effect of nebulized 4.2% sodium bicarbonate on the clinical and inflammatory status of ventillated patients with COVID-19 pneumonia<br>To assess the safety of nebulized 4.2% sodium bicarbonate in ventillated patients with COVID-19 pneumonia;Timepoint(s) of evaluation of this end point: the change in PaO2/FiO2 (Horowitz index): at day 7<br>the number of Ventillator Free Days (VFD): at day 28<br>;Primary end point(s): - the change in PaO2/FiO2 (Horowitz index) <br>- the number of Ventillator Free Days (VFD) in an interval of 28 days<br> | | | | Yes | False | | |
| EUCTR2020-004272-17-BE | 26 April 2021 | A controlled Phase 2/3 study of adjuvanted recombinant SARS-CoV-2 trimeric S-protein vaccine (SCB-2019) for the prevention of COVID-19 | A Double-Blind, Randomized, Controlled, Phase 2/3 Study to Evaluate the Efficacy, Immunogenicity, and Safety of CpG 1018/Alum-Adjuvanted Recombinant SARS-CoV-2 Trimeric S-protein Subunit Vaccine (SCB-2019) for the Prevention of SARS-CoV-2-mediated COVID-19 in Participants Aged 18 years and Older - SPECTRA | | Clover Biopharmaceuticals AUS Pty Ltd | 18/11/2020 | 20201118 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004272-17 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 25/03/2021 | 22000 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Nepal;Colombia;Germany;South Africa;Dominican Republic;Guatemala;Belgium;Brazil;Poland;Philippines;Panama | Htay Htay Han | | Level 17, HWT Tower, 40 City Road | htayhtay.han@cloverbiopharma.com | | Clover Biopharmaceuticals AUS Pty Ltd | Inclusion criteria: <br>1. Male or females =18 years of age, inclusive.<br>2. Participants who are willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests, the electronic completion of the COVID-19 ePRO and other study procedures.<br>3. Healthy adults or adults with pre-existing medical conditions who are in stable condition.<br>A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment.<br>Note: The first 200 individuals enrolled in the Phase 2 part of the study should be healthy subjects 18 to 64 years or age without comorbidities associated with a high risk of severe COVID-19.<br>4. Female subjects are eligible to participate in the study if not pregnant, not breastfeeding, and at least 1 of the following criteria apply:<br>• Women of childbearing potential (WOCBP) must have a negative urine pregnancy test prior to each vaccination. A confirmatory serum pregnancy test may be conducted at the Investigator’s discretion. They must be using a highly effective licensed method of birth control for 30 days prior to the first vaccination and must agree to continue such precautions during the study until 90 days after the second vaccination.<br>5. Male subjects must agree to employ acceptable contraception from the day of first dose of the study vaccine/placebo until 6 months after the last dose of the study vaccine/placebo and also refrain from donating sperm during this period.<br>6. Individuals (or their legally acceptable representative based on local regulations) willing and able to give an informed consent, prior to screening.<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 16500<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 5500<br> | Exclusion criteria: <br>1. Individuals with laboratory-confirmed SARS-CoV-2 infection (e.g., a positive RT-PCR or Rapid COVID-19 antigen test).<br>2. Individuals with behavioral or cognitive impairment (including drug and alcohol abuse) in the opinion of the Investigator.<br>3. Individuals with any progressive or severe neurologic disorder, seizure disorder, or history of Guillian-Barré syndrome.<br>4. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, e.g., for cancer or an autoimmune disease, or planned receipt during the study period. If a short-term course of systemic corticosteroids have been administered for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 30 days before the first study vaccination. A unique dose of systemic steroids on a single day would be allowed, as well as inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.<br>5. Individuals who are pregnant, or breastfeeding, or planning to become pregnant during the study period.<br>6. Individuals who have a history of severe adverse reaction associated with a vaccine or severe allergic reaction (e.g., anaphylaxis) to any component of the study vaccine (SCB-2019, CpG 1018 Adjuvant and Aluminum hydroxide/SCB-2019 components as outlined in the latest IB).<br>7. Individuals who have a history of malignancy within 1 year before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix which have been cured, or other malignancies with minimal risk of recurrence).<br>8. Individuals who have received any other investigational product within 30 days prior to Day 1 or intent to participate in another clinical study at any time during the conduct of this study.<br>9. Individuals who have received previous vaccination with any coronavirus vaccine.<br>10. Individuals who have received any other licensed vaccines within 14 days prior to enrollment in this study or who are planning to receive any vaccine up to 14 days after the second vaccination.<br>11. Individuals with known bleeding disorder that would, in the opinion of the investigator, contraindicate intramuscular injection.<br>12. Individuals who received any blood/plasma products or immunoglobulins within 60 days prior to Day 1 or plan to receive it during the study period.<br>13. Individuals with any condition that, in the opinion of the Investigator, may increase the risk of study participation or interfere with the assessment of the primary study objectives<br>14. Individuals with fever >37.8°C (=100.04°F; irrespective of method), or any acute illness at baseline (Day 1) or within 3 days of randomization. Participants meeting this criterion may be rescheduled within the relevant window. Afebrile participants with minor illnesses can be enrolled at the discretion of the investigator.<br> | SARS-CoV-2-mediated COVID-19 <br>MedDRA version: 23.1
Level: LLT
Classification code 10084465
Term: COVID-19 vaccination
System Organ Class: 100000004865
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: SCB-2019 (CpG 1018/Alum-djuvanted SCB-2019)<br>Product Code: SCB-2019<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Not available<br>Current Sponsor code: SCB-2019<br>Other descriptive name: SARS-CoV-2 spike trimer fusion protein, recombinant<br>Concentration unit: µg/ml microgram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 720-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intramuscular use<br><br> | Timepoint(s) of evaluation of this end point: For efficacy endpoint: First occurrence of any RT-PCR-confirmed COVID-19 with onset at least 14 days after the second study vaccination<br><br>For safety and reactogenecity endpoints: For SAEs, AEs leading to early termination from the study: during the entire study period;Primary end point(s): First occurrence of any RT-PCR-confirmed COVID-19 of any severity with onset at least 14 days after the second study vaccination in subjects without evidence of prior SARS-CoV-2 infection.<br>Local and systemic solicited AEs reported within 7 days after each study vaccination (in Phase 2 subjects)<br>Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 43 (in Phase 2 subjects)<br>SAEs, AEs leading to early termination from the study, MAAEs, and AESIs during the entire study period (in all subjects).;Secondary Objective: Secondary Efficacy Objectives:<br>- Vaccine Efficacy Against Any RT-PCR Confirmed Moderate-to-Severe COVID-19<br>- Vaccine Efficacy Against Any Laboratory-Confirmed SARS-CoV-2 Infection<br>- Vaccine Efficacy Against Any RT-PCR-Confirmed Severe COVID-19<br>- Vaccine Efficacy Against Any Laboratory-Confirmed Asymptomatic SARS-CoV-2 Infection<br>- Vaccine Efficacy Against Burden of Disease (BOD)<br>- Vaccine Efficacy Against Any RT-PCR-Confirmed COVID-19 of Any Severity, Associated with Hospitalization<br>- Vaccine Efficacy by Evidence of Prior SARS-CoV-2 Infection and Risk of Severe COVID-19<br>- Vaccine Efficacy After the First Dose<br><br>Secondary Immunogenicity Objectives: To assess the immunogenicity of CpG 1018/Alum-adjuvanted SCB 2019 vaccine in Phase 2 subjects<br>To assess the immune response against Trimer Tag domain of SCB 2019 in Phase 2 subjects<br><br>Secondary Safety Objective: To assess the immune response against Trimer Tag domain of SCB 2019 in Phase 2 subjects<br><br><br><br>;Main Objective: 1. Primary Efficacy Objective: Vaccine Efficacy Against RT-PCR-Confirmed COVID-19 of Any Severity: To demonstrate the efficacy of CpG 1018/Alum-adjuvanted SCB-2019 vaccine for the prevention of any RT-PCR-confirmed COVID-19 of any severity in subjects without evidence of prior SARS-CoV-2 infection.<br>2. Primary Safety and Reactogenicity Objective: To assess the safety and reactogenicity of CpG 1018/Alum-adjuvanted SCB-2019 vaccine compared to placebo.<br> | | | | Yes | False | | |
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| EUCTR2020-001857-31-BG | 26 April 2021 | A clinical study to test if a drug called PLX-PAD is both safe and can help in the treatment of COVID-19 patients | A Randomized, Controlled, Multicenter, Parallel-Group Phase IIa Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of severe COVID-19 | | Pluristem Ltd. | 13/11/2020 | 20201113 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001857-31 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 04/03/2021 | 40 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: Standard of care
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany;Bulgaria;Israel | Clinical Trial Information | | Matam Park, Building 05 | Lirans@pluristem.com | +972747107116 | Pluristem Ltd. | Inclusion criteria: <br>Subjects must meet all of the inclusion criteria listed below to be eligible for the study:<br>1. Willing and able to provide written informed consent, or with a legal representative (as defined by local regulation) who can provide informed consent.<br>2. Male or non-pregnant female 18 to 85 years of age at time of randomization.<br>3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen within up to 28 days prior to randomization.<br>4. Meets definition of ARDS according to Berlin criteria with oxygenation of PaO2/FIO2 = 200mm Hg (graded as Moderate or Severe).<br>5. By the time of expected treatment initiation on invasive mechanical ventilation for less than 72 hours.<br>6. Women of childbearing potential must have a negative serum pregnancy test at primary screening and must be willing to use at least one highly effective birth control method<br>throughout the study.<br>Any female subject who is surgically sterile, or with bilateral tubal occlusion, or whose partner is vasectomized, or who reliably applies sexual abstinence or who is postmenopausal (one year<br>without menses) will be considered not of childbearing potential.<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 20<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 20<br> | Exclusion criteria: <br>Subjects with any one of the exclusion criteria listed below will not be eligible for the study (based on medical record at current admission): <br>1. Mild ARDS as defined by Berlin criteria (200 mm Hg < PaO2/FIO2 = 300mmHg)<br>2. Body weight under 55 kg (121 lbs)<br>3. Stage 4 and above chronic kidney disease (clearly defined in patient’s medical history, eGFR <30 mL/min/1.73m2 [based on MDRD equation]) or patients that require renal replacement<br>therapy for any reason at time of primary screening.<br>4. Serum creatinine level of over 3 mg/dL at last test before randomization.<br>5. Total Bilirubin =3 mg/dL at last test before randomization.<br>6. Continuous administration of vasoactive agents required due to shock at time of randomization (either one): dopamine >15 (mcg/kg/min), vasopressin >0.04 (units/min), phenylephrine >1<br>(mcg/kg/min), epinephrine =0.3 (mcg/kg/min), or norepinephrine =0.3 (mcg/kg/min).<br>7. Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin.<br>8. Stroke or acute myocardial infarction within 3 months before current hospital.<br>9. Congestive heart failure (New York Heart Association [NYHA] class III-IV) at primary screening (stated in medical history) or investigator discretion as to presence of moderate to severe baseline congestive heart failure.<br>10. Chronic Obstructive Pulmonary disease GOLD stage above III (Stated in medical history or investigator discretion of severe COPD.<br>11. Other chronic pulmonary disease under chronic oxygen treatment.<br>12. Known medical history of Acquired immunodeficiency syndrome (AIDS) or HIV under chronic treatment.<br>13. Known medical history of Active acute or chronic HBV or HCV .<br>14. Known medical history of active tuberculosis or active tuberculosis including under treatment at time of primary screening .<br>15. Pre-existing significant coagulopathies that put the patient at an increased risk of major bleeding according to the Investigator’s judgment.<br>16. History of thromboembolism or known chronic hypercoagulopathic syndrome\state.<br>17. Subjects under acute or chronic anticoagulant therapy (warfarin with international normalized ratio (INR) >2 or Direct Oral Anticoagulants, or full dose subcutaneous or intravenous<br>treatment for atrial fibrillation and\or prosthetic heart valves, and or suspicion or proven thromboembolic events), unless this therapy is required and can be safely modified , according<br>to local clinical routines (e.g. PTT monitoring, timing of low molecular heparin injections), around the time of PLX-PAD injections based on the study Investigator’s/ treating physician’s discretion and patient’s risk of bleeding.<br>18. Subject is currently enrolled in another controlled clinical trial(s) with investigational drug, unless in long-term follow-up phase (in which there is no IP administration).<br>19. Exposure to allogeneic cell-based therapy in the past or exposure to autologous cell therapy in the last 12 months before screening.<br>20. History of solid organ transplantation.<br>21. Active malignancy or history of malignancy within 3 years prior to screening except for successfully resected skin basal cell carcinoma or skin squamous cell carcinoma.<br>22. Treatment with extracorporeal membrane oxygenation (ECMO) support (at time of randomization).<br>23. In the opinion of the Investigator, the subject is unsuitable for participating in the study.<br> | Pneumonia or Acute Respiratory Distress Syndrome (ARDS) caused by severe COVID-19 disease <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: PLX-PAD<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: emiplacel<br>Other descriptive name: PLX-PAD<br>Concentration unit: Munit million units<br>Concentration type: up to<br>Concentration number: 300-<br><br> | Timepoint(s) of evaluation of this end point: day 28;Primary end point(s): Number of ventilator free days (time-frame of 28 days from Day 1 through Day 28 of the study, inclusive);Secondary Objective: Not applicable;Main Objective: To evaluate the efficacy and safety of intramuscular (IM) administration of PLX-PAD for the treatment of severe COVID-19 | | | | Yes | False | | |
| → | EUCTR2020-003998-22-DE | 26 April 2021 | Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older | COVID-19: A Phase 2b/3, Randomized, Observer-Blinded, Placebo Controlled, Multicenter Clinical Study Evaluating the Efficacy and Safety of Investigational SARS-CoV-2 mRNA Vaccine CVnCoV in Adults 18 Years of Age and Older - HERALD | | CureVac AG | 19/11/2020 | 20201119 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-003998-22 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 11/12/2020 | 36500 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: Observer-blinded
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Germany;Colombia;Netherlands;Peru;Dominican Republic;Belgium;Spain;Argentina;Mexico;Panama→Spain;Belgium;Dominican Republic;Peru;Netherlands;Colombia;Germany;Argentina;Mexico;Panama | Clinical Trial Information | | Schumannstr. 27 | clinicaltrials@curevac.com | 00496976805870 | CureVac AG | Inclusion criteria: <br>1. Male or female subjects 18 years of age or older.<br>2. Be willing and able to provide written informed consent prior to initiation of any trial procedures.<br>3. Expected compliance with protocol procedures and availability for clinical follow-up through the last planned visit.<br>4. Females of non-childbearing potential defined as follows: surgically sterile (history of bilateral tubal ligation/occlusion, bilateral oophorectomy or hysterectomy) or postmenopausal {defined as amenorrhea for = 12 consecutive months prior to screening (Day 1)} without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the Investigator to confirm postmenopausal status. <br>5. Females of childbearing potential: negative pregnancy test {human chorionic gonadotropin (hCG)} within 24 hours prior to each trial vaccination on Day 1 and Day 29. <br><br>Full list of inclusion criteria is provided in the protocol.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 30000<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 6500<br> | Exclusion criteria: <br>1. History of virologically-confirmed COVID-19 illness. <br>2. For females: pregnancy or lactation. <br>3. Use of any investigational or non-registered product (vaccine or drug) within 28 days preceding the administration of the first trial vaccine or planned use during the trial.<br>4. Receipt of licensed vaccines within 28 days (for live vaccines) or 14 days (for inactivated or any other vaccines) prior to the administration of the first trial vaccine.<br>5. Prior administration of any investigational SARS-CoV-2 vaccine or another coronavirus (SARS-CoV, MERS-CoV) vaccine or planned use during the trial.<br><br>Full list of exclusion criteria is provided in the protocol.<br> | Vaccination for prophylaxis of COVID-19 (healthy adults) <br>MedDRA version: 23.1
Level: LLT
Classification code 10084464
Term: COVID-19 immunization
System Organ Class: 100000004865
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: CVnCoV<br>Product Code: CV07050101<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Zorecimeran<br>Current Sponsor code: R9515<br>Concentration unit: g/l gram(s)/litre<br>Concentration type: equal<br>Concentration number: 1-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intramuscular use<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intramuscular use<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intramuscular use<br><br> | Timepoint(s) of evaluation of this end point: as specified in the endpoints;Primary end point(s): Primary Efficacy Endpoints<br>• Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 of any severity meeting the case definition for the primary efficacy analysis. <br><br>Primary Safety Endpoints <br>All safety endpoints will be analyzed in all subjects, in subjects seronegative at baseline, and in subjects seropositive at baseline.<br>• Occurrence, intensity and relationship of medically-attended AEs collected through 6 months after the second trial vaccination in all subjects.<br>• Occurrence, intensity and relationship of SAEs and AESIs collected through 1 year after the second trial vaccination in all subjects.<br>• Occurrence of fatal SAEs through 1 year after the second trial vaccination in all subjects. <br>• Occurrence, intensity and duration of each solicited local AE within 7 days after each trial vaccination in Phase 2b subjects. <br>• Occurrence, intensity, duration of each solicited systemic AE within 7 days after each trial vaccination in Phase 2b subjects.<br>• Occurrence, intensity and relationship of unsolicited AEs occurring within 28 days after each trial vaccination in Phase 2b subjects.<br>• Occurrence of AEs leading to vaccine withdrawal or trial discontinuation through 1 year after the second trial vaccination in all subjects.;Secondary Objective: Key Secondary Efficacy Objectives<br>• To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed moderate to severe cases of COVID-19 in SARS-CoV-2 naïve subjects.<br>• To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed severe cases of COVID-19 in SARS-CoV-2 naïve subjects. <br>• To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity caused by “wild type” (i.e., WT/D614G lineages A.1 / B.1 without the variant of concern [VOC] B.1.1.7, B.1.351, B.1.429) and “UK” (B.1.1.7) SARS CoV 2 strains in SARS CoV 2 naïve subjects.<br><br>Full list of secondary objectives is provided in the protocol.;Main Objective: Primary Efficacy Objectives<br>• To demonstrate the efficacy of a 2-dose schedule of CVnCoV in the prevention of first episodes of virologically-confirmed cases of COVID-19 of any severity in SARS-CoV-2 naïve subjects. <br><br>Primary Safety Objectives<br>• To evaluate the safety of CVnCoV administered as a 2-dose schedule to subjects 18 years of age and older. <br>• To evaluate the reactogenicity of CVnCoV administered as a 2-dose schedule to subjects 18 years of age and older participating in Phase 2b of the trial. | | | | Yes | True | parent | |
| IRCT20190810044500N5 | 26 April 2021 | Effect of colchicine in treatment of COVID-19 | Investigation of the efficacy and safety of colchicine In combination with standard treatment on covid-19 patients: A clinical trial | | Yazd University of Medical Sciences | 2020-05-18 | 20200518 | IRCT | http://en.irct.ir/trial/46867 | Not Recruiting | No | 18 years | 70 years | Both | 2020-04-04 | 200 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: At the beginning of the study, patients will be assigned to one of the two divided groups with a random number table, Blinding description: All stages will be covered by the patient, the treating physician and the evaluators. In this way, the first executor of the sequence plan specifies the allocation of people according to the order of admission of sick people to the study and pours the drugs into one-packets for consumption for two weeks and identifies them with A or B codes. Then, the drugs suitable for each person are identified according to the above explanations and placed in special envelopes and delivered to patients. One group is given a placebo and standard treatment and the other group is given a colchicine and standard treatment. | 3 | Iran (Islamic Republic of);Iran (Islamic Republic of) | Nadia Soltani Gerdefaramarzi | | Unit 701,Floor7,Negar complex, Negaran alley, Jomhouri Blvd | nadia.slt75@gmail.com | +98 35 3521 5048 | Yazd University of Medical Sciences | Inclusion criteria: - Age 18 to 70 years<br>- Detection of COVID-19 in the last 24 to 48 hours<br>- Candidate for hospitalization (o2sat <93% or RR> 24 or Pao2 / Fio2 <300)<br>- COVID-19 patients hospitalized with hospital indications according to the guideline of the country that has pulmonary infiltration in CT scan<br>-Not being pregnant and not becoming pregnant until 30 days after the end of the study<br>- No consumption of colchicine during the last week ( due to the half-life of 20-40 hours of the drug)<br>- Outpatients with pulmonary infiltration on CT scan | Exclusion criteria: Patients with a history of Crohn or Ulcerative colitis, diarrhea, or chronic malabsorption<br>Neuromuscular diseases<br>GFR less than 30 ml per minute<br>History of cirrhosis, hepatitis and severe liver disease<br>Patients receiving chemotherapy for cancer<br>Patients currently taking colchicine for other uses, such as gout or Mediterranean fever<br>Patients with a history of allergic reactions or allergies to colchicine<br>Pregnancy and lactation | COVID-19. <br>COVID-19,virus identified;U07.1 | Intervention 1: Intervention group: Receive 0.5 mg of colchicine until the third day and 12 days later one mg plus standard treatment including 200 mg hydroxychloroquine daily. Intervention 2: Control group: From the first to the third day, two tablets of placebo and for the next 12 days, one daily dose in addition to the standard treatment (200 mg hydroxychloroquine daily). | Laboratory symptoms (ESR, CRP, NLR, LDH, ferritin, D-dimer, CBC diff). Timepoint: Hospitalization time and discharge time. Method of measurement: Blood test.;O2sat at the time of hospitalization and discharge. Timepoint: The first, third, seventh, fourteenth and 6-8 days after entering the study. Method of measurement: Pulse Oximeter.;Pulmonary infiltration findings on CT scan. Timepoint: Two weeks later and 6-8 weeks later. Method of measurement: CT-scan.;-Clinical symptoms including fever, cough, shortness of breath. Timepoint: The first, third, seventh, fourteenth and 6-8 days after entering the study. Method of measurement: questionnaire. | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| IRCT20200707048047N1 | 26 April 2021 | colchicine effect on persistent dyspnea in COVID19 | Effects of colchicine on persistent dyspnea and pulmonary fibrosis of COVID-19 patients after hospital discharge | | Islamic Azad University | 2021-03-27 | 20210327 | IRCT | http://en.irct.ir/trial/49766 | Recruiting | No | 18 years | no limit | Both | 2020-07-22 | 40 | interventional | Randomization: Not randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Blinding description: in this study both control and treatment group receive supportive treatment. drug and placebo are packed in packages and are blindly distributed between patients.principle investigators and health care providers were blinded in this study. | 2 | Iran (Islamic Republic of) | masoumeh moallem | | Dastgerdi | masoumehmoallem@gmail.com | +98 21 2222 3567 | Islamic Azad University | Inclusion criteria: history of covid19 infection confirmed with lung lesion in CT scan and/or positive PCR | Exclusion criteria: history of taking colchicine..history of ipf.non consent<br>pregnancy<br>history of allergic reaction to colchicine<br>immunosuppressive drug consumption<br>history of chronic dyspnea or dyspnea on exertion due to underlying diseases<br>non consent in any stage of study | COVID19. <br>U07.1;U07.1 | Intervention group: patients with history of Covid19 infection with persistent dyspnea and pulmonary fibrosis receive colchicine 0.5mg BID for 3 days and then 0.5 mg daily for 1 month. | ???? ???? ??? ?? ???? ???? ???? UCSD. Timepoint: Before intervention,1and6months after intervention. Method of measurement: UCSD questionnaire. | | | | No | False | | |
| → | IRCT20150815023620N9 | 26 April 2021 | Evaluation of the effect of herbal food product in patients with COVID 19 | Evaluation of the effect of herbal food product (Shad syrup) in patients with COVID 19 | | Shahid Beheshti University of Medical Sciences | 2021-03-13 | 20210313 | IRCT | http://en.irct.ir/trial/52045 | Not Recruiting | No | 30 years | 60 years | Both | 2020-04-01 | 150 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: With simple randomization and using a random number table and individual randomization unit. To randomize, we use a table consisting of random digits 0 to 9. Each digit of this table is repeated the same on average. There is no pattern of recognizable numbers. In this method, each number is assigned to a treatment group. We start from the first line of the table and move down line by line. For the two treatments, we put the numbers 0 to 4 for treatment A and the numbers 5 to 9 for treatment B. The numbers in the first line of the table are as follows: 0,5,2,7,8,4,3,7,4,1,6,8,3,8,5,1,5,6,9,6, ...
Now for people based on the above numbers, we have the following allocation:
A, B, A, B, B,...
We will continue the above process until the two groups are completed. | 3 | Iran (Islamic Republic of) | Dr Mohammadreza Moshari | | Taleghani Educational Hospital, Shahid Aarabi Ave, Yaman St, Chamran High Way | Rmoshari@sbmu.ac.ir | +98 21 2243 2595 | Shahid Beheshti University of Medical Sciences | Inclusion criteria: confirmed COVID-19 infection with Lab tests not considering sign and symptoms<br>suspected COVID-19 infection based on national protocol include the patients who has respiratory signs and pulmonary unilateral or bilateral multilobar infiltration in CT scan or chest radiography<br>suspected patient to pneumonia with uncommon rapid deterioration and fast worsening of clinical status and not responding to proper treatments<br>age 30 to 65 | Exclusion criteria: late visit more than 5 days of onset of symptoms<br>pregnancy and breastfeeding<br>alergy history<br>complicated bacterial infection<br>severe and critical patients ( ARDS and MODS )<br>patient in recovery phase | COVID-19. <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: Shad syrup. The dosage of the syrup is 5 cc with 10 cc of water every 4 hours for the first two days and 5 cc every 6 hours for the next two days, which is given to the patient by the ward nurse and its consumption is monitored. Intervention 2: Control group: placebo. The dose is equivalent to non-drug syrup for the first two days every 4 hours 5 cc with 10 cc of water and the next two days every 6 hours 5 cc which is given to the patient by the ward nurse and its consumption is monitored. | Cr. Timepoint: Daily. Method of measurement: Biochemical testing.;BUN. Timepoint: Daily. Method of measurement: Biochemical testing.;SGOT. Timepoint: Daily. Method of measurement: Biochemical testing.;SGPT. Timepoint: Daily. Method of measurement: Biochemical testing.;LDH. Timepoint: Daily. Method of measurement: Biochemical testing.;ESR. Timepoint: Daily. Method of measurement: ESR Reader.;CRP. Timepoint: Daily. Method of measurement: Biochemical testing.;SPO2. Timepoint: Daily. Method of measurement: Pulse oximetry.;Fever (temperature ). Timepoint: Daily. Method of measurement: Thermometer.;Death. Timepoint: daily. Method of measurement: Patient record.→Death. Timepoint: daily. Method of measurement: Patient record.;Fever (temperature ). Timepoint: Daily. Method of measurement: Thermometer.;SPO2. Timepoint: Daily. Method of measurement: Pulse oximetry.;CRP. Timepoint: Daily. Method of measurement: Biochemical testing.;ESR. Timepoint: Daily. Method of measurement: ESR Reader.;LDH. Timepoint: Daily. Method of measurement: Biochemical testing.;SGPT. Timepoint: Daily. Method of measurement: Biochemical testing.;SGOT. Timepoint: Daily. Method of measurement: Biochemical testing.;BUN. Timepoint: Daily. Method of measurement: Biochemical testing.;Cr. Timepoint: Daily. Method of measurement: Biochemical testing. | | | | No | False | | |
| IRCT20130812014333N164 | 26 April 2021 | Investigation of the effects of the exosomes on patients with COVID-19 | Investigation of the effects of the exosomes derived from placental mesenchymal stem cells on the oxygen saturation and biological markers of patients with COVID-19 | | Kermanshah University of Medical Sciences | 2021-04-01 | 20210401 | IRCT | http://en.irct.ir/trial/52416 | Not Recruiting | No | no limit | no limit | Both | 2020-12-05 | 8 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Using the random number table, patients are divided into two groups of at least 4. Each patient is assigned a 4-digit code based on the random number table, Based on the right number of patients code, the patients are divided into two groups. Patients whose last digit is 2, 4, 6, 8 will be assigned to the intervention group and patients whose last digit is 1,3,5, 7 will be assigned to the control group, Blinding description: In this double-blinded study, the researcher and the patient are unaware of who is receiving the new drug. Initially, a code is considered by the nurse for the intervention group and the placebo group. The code of the intervention group is A and the code of the placebo group is B.The new drug and placebo are injected into the serum, which is the same shape and size for both groups. | 2-3 | Iran (Islamic Republic of) | Dr. Kamran Mansouri | | Emam Reza Hospital, Parastar Boulevard | kamranmansouri@gmail.com | +98 83 3427 6306 | Kermanshah University of Medical Sciences | Inclusion criteria: Infected patients with Corona virus based on CRISPR test (PCR)<br>Diagnosis of acute respiratory syndrome according to Berlin criteria<br>Requires oxygenation or confirmed pneumonia by radiologically or CT<br>Oxygen uptake concentration<br>Progression of of pulmonary edema more than 50% within 24-48 hours<br>Mild to moderate pneumonia caused by a new coronavirus | Exclusion criteria: Serious underlying illness or psychosis<br>Co-infection with HIV, tuberculosis, influenza virus, adenovirus and other viral respiratory infections<br>Liver or kidney SOFA score more than 3 | COVID-19. <br>COVID-19;U07.1 | Intervention 1: The intervention group in addition to the usual treatment will receive single-dose exosomes (one billion exosomes per kilogram) twice on two consecutive days by injection. Regarding the pharmaceutical company, it has not a pharmaceutical company, separation and processing are done in the cell culture laboratory of the Biological Research Center of Kermanshah University of Medical Sciences. Intervention 2: The control group, in addition to the placebo(50cc dextrose saline), will receive the usual medicine (Recigen; 12000000 unit every other day till 5 dosages, Kaletra, sevodak: daily for 5 days, high dose dexamethasone for 7 days with tapering). | Ferritin. Timepoint: 2 to 3 days after injection,daily for two weeks. Method of measurement: Using a blood test and Chemiluminescence immunoassay method.;Neutrophil to lymphocyte ratio. Timepoint: 2 to 3 days after injection,daily for two weeks. Method of measurement: Using a blood test (To determine the percentage of neutrophils and lymphocytes, the optical method or light microscope and Giemsa staining is used).;Oxygen saturation. Timepoint: 2 to 3 days after injection,daily for two weeks. Method of measurement: Using a pulse oximeter. | | | | No | False | | |
| IRCT20200927048849N3 | 26 April 2021 | Effect of hyperimmune bovine milk & colostrum in the healing process of COVID-19 patients | Comparison of the Effectiveness of COVID-19 specific antibody in hyper-immune bovine milk & colostrum with ordinary bovine milk & colostrum on reducing the need for hospitalization and improving clinical symptoms of patients with COVID-19 that are taken care of in home. | | Isfahan university | 2021-03-17 | 20210317 | IRCT | http://en.irct.ir/trial/52429 | Recruiting | No | 18 years | no limit | Both | 2021-03-20 | 600 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients list with positive PCR is received through health center daily and numbered. Participants of the study are divided in two groups Using a simple randomization method using a table of random numbers and according to the entry and exit criteria. Such that the patients with even number are given hyperimmune milk and patients with odd number are given ordinary milk, Blinding description: Referral patients to clinic with COVID-19 diagnosis by positive PCR from Nazopharynx are divided in two groups using a simple randomization method using a table of random numbers. Milks have two types hyperimmune and ordinary that are named as A and B on the top but their packaging are quite the same. One group is given milk A (ordinary or placebo) and the other group is given milk B or hyperimmune milk. The doctor, patient and distributor are not informed of | 3 | Iran (Islamic Republic of) | Hassan Niliahmadabadi | | No. 5 apartment unit, Parmisa building, alley No. 5, Mehrabad avenue, Mehrabad neighbourhood | nili@shirazu.ac.ir | +98 31 3261 6334 | Virus research center of Isfahan university | Inclusion criteria: Infected patients of COVID-19 based on positive Polymerase Chain Reaction test<br>Lack of hospitalization indication based on country protocol<br>O2 Saturation more than 93% on the first visit<br>Respiratory rate more than 24 on the first visit<br>Age more than 18 years old<br>Filling and signing of consent form<br>A maximum of 10 days have elapsed since the onset of disease symptoms | Exclusion criteria: Patients with immunodeficiency based on biography<br>Lactose intolerance based on biography<br>Uncontrollable vomiting<br>Using antiviral drugs<br>Pregnancy<br>Failure to fill out the consent form<br>Receiving immunosuppressive drugs | Covid-19 viral pneumonia. <br>Pneumonia due to SARS-associated coronavirus;J12.81 | Intervention 1: Intervention group: Referred COVID-19 patients to clinic of Alzahra hospital after explaining the study and obtaining consent the will be given twice a day, morning and evening 150 cc of vaccined cow's milk by COVID-19 virus antigen (hyperimmune milk). Intervention 2: Control group: Referred Covid-19 patients to clinic of Alzahra hospital in Isfahan after explaining the study and obtaining consent form will be given twice a day, morning and evening 150 cc of ordinary bovine milk (placebo milk). | Need of Hospitalization during the next 14 days. Timepoint: 14 days after using the milk. Method of measurement: By phone call.;Need to go to the emergency room during 14 days. Timepoint: 14 days after using the milk. Method of measurement: By phone call.;No fever and appearance of it. Timepoint: In days of 3, 5, 7, 10 and 14 after beginning the treatment. Method of measurement: By phone call.;No cough and appearance of it. Timepoint: In days of 3, 5, 7, 10 and 14 after beginning the treatment. Method of measurement: By phone call.;No shortness of breath and appearance of it. Timepoint: In days of 3, 5, 7, 10, 14 after beginning the treatment. Method of measurement: By phone call.;No muscular pain and appearance of it. Timepoint: In days of 3, 5, 7, 10, 14 after beginning the treatment. Method of measurement: By phone call.;Mortality rate during 28 days after beginning of the disease. Timepoint: 28 days after beginning of disease. Method of measurement: By phone call.;ICU need during 28 days after beginning the disease. Timepoint: 28 days after beginning of disease. Method of measurement: By phone call. | | | | Yes | False | | |
| → | IRCT20200823048495N1 | 26 April 2021 | COVID-19 Cure Using Integrative Treatment | The Effectiveness of Integrative Treatment Interventions on Covid-19 Patients: A Single Group, Pretest-Posttest clinical Trial | | Knowledge Research and Innovation Center, Pakistan (KRIC) | 2020-12-12 | 20201212 | IRCT | http://en.irct.ir/trial/52742 | Not Recruiting | No | 18 years | 75 years | Both | 2020-01-17 | 39 | interventional | Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. | 1 | Pakistan | Umber Nawaz | | 9 Noon Avenue, Block C, Muslim Town, Canal Road, Lahore, Punjab, Pakistan | umber@kric.edu.pk | +92 42 35440889 | Knowledge Research and Innovation Center, Pakistan (KRIC) | Inclusion criteria: Both genders<br>Aged between 18-80 years<br>Mild, moderate or severe infection<br>COVID-19 positive on the basis of symptoms, physical test and lab test | Exclusion criteria: Any tumor or malignancy<br>Recent surgery<br>Patient on invasive / non-invasive ventilator (critical)<br>Taking any other medicine parallel to PAK-20, Oniater and Hing for treatment of COVID-19.<br>Taking any immunosuppressant | SARS-COV-2. <br>SARS-associated coronavirus as the cause of diseases classified elsewhere;B97.21 | Single intervention group. Methods: 34 COVID-19 patients (males and females) with mild to severe symptoms were given the Intervention. Baseline treatment; 1gm of PAK-20 in 250ml of Combo 1 (soup/meat stock) twice a day for a max of 12 days, 50 ml of Oniater (onion water) once a day for 3 days. Hing (Asafoetida) tempering added to daily food diet to address blood clotting, or coagulation. Supplementary treatment; Combo 2 (herbal tea), 250ml of twice a day for a maximum of 12 days. Datseed (date filled with black seeds, once a day for a maximum of 12 days. Use of protein heavy diets, fruits, milk shakes and fresh juices given even beyond 12 days. Use of 70gm of Talbina once per day, which served as high potency oral multivitamins energy diet.. | Muscle Pain. Timepoint: Before intervention and (1,3,5,7,9,11) odd days after intervention. Method of measurement: Numeric pain rating Scale.;Shortness of Breath. Timepoint: Before intervention and (1,3,5,7,9,11) odd days after intervention. Method of measurement: Borg Scale of Short of Breath.;Sore Throat. Timepoint: Before intervention and (1,3,5,7,9,11) odd days after intervention. Method of measurement: Sore Throat Scale.;Cough. Timepoint: Before intervention and (1,3,5,7,9,11) odd days after intervention. Method of measurement: Cough Scale.;Fever. Timepoint: Before intervention and (1,3,5) odd days after intervention. Method of measurement: Thermometer.→Fever. Timepoint: Before intervention and (1,3,5) odd days after intervention. Method of measurement: Thermometer.;Cough. Timepoint: Before intervention and (1,3,5,7,9,11) odd days after intervention. Method of measurement: Cough Scale.;Sore Throat. Timepoint: Before intervention and (1,3,5,7,9,11) odd days after intervention. Method of measurement: Sore Throat Scale.;Shortness of Breath. Timepoint: Before intervention and (1,3,5,7,9,11) odd days after intervention. Method of measurement: Borg Scale of Short of Breath.;Muscle Pain. Timepoint: Before intervention and (1,3,5,7,9,11) odd days after intervention. Method of measurement: Numeric pain rating Scale. | | | | No | False | | |
| IRCT20110423006257N3 | 26 April 2021 | Thalidomide effects in COVID-19 | A clinical trial to evaluate the therapeutic effects of thalidomide in patients with COVID-19 infection | | Arak University of Medical Sciences | 2021-04-03 | 20210403 | IRCT | http://en.irct.ir/trial/53279 | Recruiting | No | 18 years | 80 years | Both | 2021-04-09 | 66 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Balanced block randomization is used as a randomization method. Patients are divided into two groups using the above method. Therefore, six four-part combinations of intervention groups A and B are as follows : AABB, ABAB, ABBA, BBAA, BABA, BAAB.
Then we assign them from the number one to six and with the table of random numbers from the right side of the selected number, move in order and select each of the numbers 1 to 6 of the above combination that appears, and the people who agree to participate in Study, fall into study groups. The allocation concealment will also be maintained in this method and the order of the quadruple compounds will also be completely hidden, Blinding description: In this study, the patients are randomly assigned to different groups and physicians. The physicians, patients , nurses, primary investigators, and also rese | 3 | Iran (Islamic Republic of) | Dr. Abdollatif Moini | | Iran Internal Medicin Department of Amir-al-momenin Haspital | dr.moini@arakmu.ac.ir | +98 86 1222 5202 | Arak University of Medical Sciences | Inclusion criteria: Duration of the symptoms less than 10 days<br>Lymphocyte count less than 1000 per microliter<br>Quantitative CRP more than 1.5 times normal<br>Positive pcr test of covid 19<br>O2 sat less than 93%<br>Respiratory rate less than 24<br>Chest CT scan findings compatible with COVID-19 Pneumonia | Exclusion criteria: History of chronic disease<br>Pregnant women, lactating women , sexually active premenopausal women<br>Loss of consciousness<br>Liver enzymes more than 5 times normal | Covid 19. <br>Covid 19 | Intervention 1: Intervention group: In this group, in addition to the standard drugs recommended in the protocol of the Ministry of Health and supportive measures for patients, thalidomide (Lipomed-Swiss), in a dose of 100 mg, will be administered orally for 14 days (every night). Intervention 2: Control group: In this group, standard and recommended drugs are prescribed for patients in the protocol of the Ministry of Health and supportive measures, and they receive placebo drug, both in color and shape with the main drug, for 14 days (every night). | Blood oxygen saturation. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Pulseoxymeter.;Length of hospitalization. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: observation.;Death rate. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: observation.;Radiological changes of the lung. Timepoint: Before the intervention and two weeks after the intervention. Method of measurement: Pulmonary computed topography scan. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| IRCT20111224008507N5 | 26 April 2021 | Evaluation of the effect of Ivermectin in treatment of patients admitted with COVID-19 | Double-blind placebo-controlled clinical trial of evaluating the effectiveness of Ivermectin in treatment of patients admitted with COVID-19 in 2021 | | Mazandaran University of Medical Sciences | 2021-02-22 | 20210222 | IRCT | http://en.irct.ir/trial/54402 | Recruiting | No | 5 years | no limit | Both | 2021-02-19 | 1000 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: First, using the Random number generation plugin in excel software, a table of random numbers from 1 to 1000 is prepared in a non-sequential and scattered manner, and the numbers are assigned to two intervention and control groups of 500 cases. The randomization process is performed by the methodology consultant and clinical researchers are not aware of the randomization process and will only be provided with random codes from 1 to 1000, Blinding description: After selecting the samples, none of the participants will be aware of randomization and allocation to groups. Physicians will be given a table of pre-coded numbered numbers and patients will be entered into the study in order of table numbers. Therefore, the present study will be double-blind. Ivermectin and placebo tablets will be in the same shape, color and size and will be delivered to | 3 | Iran (Islamic Republic of) | Dr Mohammad Sadegh Rezai | | Boali Hospital, Pasdaran Blv., Sari | drmsrezaii@yahoo.com | +98 11 3334 2334 | Mazandaran University of Medical Sciences | Inclusion criteria: Patients with positive coronavirus rapid test or RT-PCR<br>Age>5 years<br>Weight >15 kg<br>No treatment with antiviral drugs before and during the study<br>Informed consent for participation | Exclusion criteria: Underlying liver and kidney disease<br>Patients with acquired immunodeficiency<br>Pregnancy and lactation | COVID-19 infection. <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: The intervention group will use Iranian standard treatment protocol for COVID-19 in addition to Ivermectin 3 mg oral tablet at a dose of 0.4 mg/kg manufactured by Alborz Daru of Iran for 3 days as follows: weight 15-24, 6 mg; Weight 35-25, 12 mg; Weight 50-36, 18 mg; Weight 80-5, 24 mg and weight over 80, 0.4 mg/kg. Intervention 2: Control group: In the control group, placebo tablets made by Alborz Daru of Iran with the same shape, color and weight based dose of ivermectin will be used for three days. | Reduction in persistent cough. Timepoint: Daily until improvement. Method of measurement: Question from the patient.;Negative RT-PCR result. Timepoint: 6 days after the intervention. Method of measurement: RT-PCR.;The main complaints recovery time. Timepoint: Daily until symptoms resolve. Method of measurement: Checklist containing patient complaints.;Mortality. Timepoint: Daily. Method of measurement: Record in checklist.;Drug side effect (Wheezing, itching, skin rash, edema, and hypotension). Timepoint: Daily. Method of measurement: Question from the patient.;Reduction in tachypnea. Timepoint: Daily. Method of measurement: Medical record.;Oxigen saturation >94%. Timepoint: Daily. Method of measurement: Medical record. | | | | No | False | | |
| → | IRCT20180728040617N3 | 26 April 2021 | Effect of Stress Management Program on Psychological Distress of Cancer Patients and Caring Burden and Quality of Life of Their Caregivers during the COVID-19 Epidemic | Effect of Stress Management Program on Psychological Distress of Cancer Patients and Caring Burden and Quality of Life of Their Caregivers during the COVID-19 Epidemic | | Shahroud University of Medical Sciences | 2021-03-14 | 20210314 | IRCT | http://en.irct.ir/trial/54613 | Recruiting | No | 15 years | no limit | Both | 2021-03-10 | 60 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Caregivers will be divided into intervention and control groups by random block allocation using quadruple blocks created by SPSS software version 22. According to the sample size of 60 in the present study, 15 quadruple blocks will be considered. Each caregiver will be randomly assigned to Group A (intervention) or B (control group) in the order determined by the software, and the sampling process will be performed sequentially until sampling is completed. Individuals are assigned to the target group in order of their entry into the study and randomly through randomized blocks. | N/A | Iran (Islamic Republic of) | Seyedmohammad Mirhosseini | | 7th Sq, Shahroud University of Medical Sciences, Shahroud, Iran. | mirhoseinim@shmu.ac.ir | +98 23 3239 3811 | Shahroud University of Medical Sciences | Inclusion criteria: Caregiver and patient age at least 15 years.<br>No psychological disorders in the caregiver.<br>No drug addiction in the caregiver.<br>No hearing or vision impairment in the caregiver.<br>The caregiver should have the most contact with the patient.<br>Ability to access the Internet and online mass communication software.<br>Have the minimum ability to use smartphones and social networks.<br>Non-participation in other supportive interventions.<br>The caregiver should not be a member of the health care system.<br>The caregiver is a family member of the patient.<br>The definitive diagnosis of cancer has been made by a doctor.<br>The stage of the disease of each patient is known<br>Patients undergo chemotherapy. | Exclusion criteria: Do not participate in the post-test.<br>Absence from more than two sessions in support sessions.<br>The reluctance of the caregiver to participate in the sessions.<br>Patient death during the study<br>Transfer the patient to other medical centers<br>Occurrence of stressful events (except for the usual treatment process) for the patient or caregiver | Cancer. <br>Malignant neoplasms;C00-C97 | Intervention 1: Intervention group: For the intervention group, 4 weekly sessions of 60 minutes are held in the form of participation in a group video call (webinar) in the form of lectures, group discussions, questions and answers, slide shows and clips. Outline of the session: (1- Stress and its effect on health, stress signs/symptoms 2- Relaxation exercises and their benefits 3- Social skills training, verbal/non-verbal communication techniques, different communication styles (aggressive, passive and assertive) 4 - Teaching coping strategies with stress (emotion-oriented and problem-oriented). Data collection tools included demographic information form, SF-36 quality of life questionnaire, Novak & Guest caring burden and Lovibond stress, anxiety and depression scale (DASS-21) which were administered by all caregivers and their patients before the intervention before the first session. (Intervention and Control Group), will be completed online. After 7 days from the end of the intervention sessions, the mentioned questionnaires will be completed to assess the effect of the intervention. Intervention 2: Control group: They will receive routine support from the treatment centre. Supporting contents will be provided to the control group after the intervention. | Caregivers Caring burden. Timepoint: At the beginning of the study (before the intervention) and 7 days after intervention. Method of measurement: Novak & Guest Caring Burden Questionnaire.;Caregivers Quality of Life. Timepoint: At the beginning of the study (before the intervention) and 7 days after intervention. Method of measurement: Quality of Life Questionnaire SF-36.→Caregivers Quality of Life. Timepoint: At the beginning of the study (before the intervention) and 7 days after intervention. Method of measurement: Quality of Life Questionnaire SF-36.;Caregivers Caring burden. Timepoint: At the beginning of the study (before the intervention) and 7 days after intervention. Method of measurement: Novak & Guest Caring Burden Questionnaire. | | | | No | False | | |
| IRCT20200405046958N2 | 26 April 2021 | Evaluation of the effect of plasmapheresis in the treatment of Covid 19 | Evaluation of the effect of therapeutic plasma exchange in patients with acute respiratory distress syndrome caused by Covid 19 disease | | Mashhad University of Medical Sciences | 2021-04-14 | 20210414 | IRCT | http://en.irct.ir/trial/54653 | Recruiting | No | 15 years | no limit | Both | 2021-03-10 | 42 | interventional | Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment, Other design features: In this study,the control group will be retrospective and the previous data will be used, matching is done based on propensity score matching and this index is used in regression models to adjust for potential confounders. | 2-3 | Iran (Islamic Republic of) | Mohammad Moeini nodeh | | internal medicine department., Ghaem hospital., ahmadabad St | MoeiniNM@mums.ac.ir | +98 51 3801 2742 | Mashhad University of Medical Sciences | Inclusion criteria: The patient must be definitive case of Covid-19 based on positive PCR test.<br>The patient must have clinical and paraclinical criteria for acute respiratory distress syndrome (ARDS)<br>The patient age must be over 15 years<br>There must be the informed consent of the patient or his/her legal guardian | Exclusion criteria: The patient has unstable hemodynamics<br>The patient has a history of previous acute cardiac infarction in the last 3 months<br>The patient has a history of allergies to blood products | Covid 19 induced acute respiratory distress syndrome. <br>Covid 19 virus identified;U07.1 | Intervention 1: Intervention group: Patients who underwent plasmapheresis for 3 days in addition to routine treatment (Includes ventilation supportive care, serum therapy, treatment with heparin or enoxaparin, famotidine or pantoprazole, low-dose dexamethasone, remdesivir, atorvastatin, and antibiotics if needed). Intervention 2: Control group: Patients who receive only the usual treatments listed. | Death. Timepoint: first 30 days of hospital admission. Method of measurement: examination of vital signs. | | | | No | False | | |
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| ChiCTR2100042374 | 26 April 2021 | Phase IIb clinical trial of recombinant novel coronavirus pneumonia (COVID-19) vaccine (Sf9 cells) | A single-center, randomized, double-blind, placebo-controlled phase IIb clinical trial of recombinant novel coronavirus pneumonia vaccine (Sf9 cells) in subjects aged 18-85 | | Jiangsu Provincial Center for Disease Control and Prevention | 2021-01-21 | 20210121 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=120494 | Recruiting | No | 18 | 85 | Both | 2021-01-28 | Adult group: Vaccine versus placebo group:2000;Elder group: Vaccine versus placebo:2000;Immunogenic subgroup group: Vaccine versus placebo:800; | Interventional study | Parallel | 2 | China | Yuquan Wei | | 17 Third Section, Renmin Road South, Chengdu, Sichuan, China | yqwei@vip.sina.com | +86 13808014326 | West China Hospital, Sichuan University | Inclusion criteria: 1. Aged 18-85 years;
<br>2. Obtain the informed consent of the subjects and sign the informed consent form;
<br>3. Subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up for approximately 14 months. -Axillary body temperature <= 37.0 degree C. | Exclusion criteria: 1. The 2019 novel coronavirus antibody (IgG and IgM) screening is positive.
<br>2. The 2019 novel coronavirus nucleic acid test is positive.
<br>3. 2019 new coronavirus infection history and 2019 new coronavirus vaccination history.
<br>4. Known history of HIV infection.
<br>5. Those with medical or family history of convulsions, epilepsy, encephalopathy, and mental illness.
<br>6. Those who are allergic to any ingredient in the research vaccine, have a history of severe vaccine allergic reactions and allergies in the past.
<br>7. Women who have a positive urine pregnancy test, are pregnant, breastfeeding, or have a pregnancy plan during the study period (within 14 months).
<br>8. Patients with acute febrile diseases and infectious diseases.
<br>9. Those who self-report a history of SARS. Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable medication, etc.
<br>10. Suffer from severe chronic diseases or the disease is in the advanced stage and cannot be controlled smoothly, such as asthma, diabetes, thyroid disease, etc.
<br>11. Malignant tumors, active tumors or tumors that have been treated without clear cure, or may recur during the study period. -Congenital or acquired angioedema/neuroedema.
<br>12. Had urticaria 1 year before receiving the trial vaccine;
<br>13. Aspleen or functional aspleen;
<br>14. Suffer from thrombocytopenia or other coagulation disorders (may cause contraindication to intramuscular injection);
<br>15. Fainted needles;
<br>16. Have received immunosuppressant therapy, anti-allergic therapy, cytotoxic therapy, and inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis);
<br>17. Received blood products within 4 months before receiving the test vaccine;
<br>18. Received other study drugs within 1 month before receiving the test vaccine;
<br>19. Received a live attenuated vaccine within 1 month before receiving the test vaccine;
<br>20. Received subunit or inactivated vaccine within 14 days before receiving the test vaccine;
<br>21. The onset of various acute or chronic diseases in the past 7 days, such as being receiving anti-tuberculosis treatment and a history of asthma;
<br>22. According to the investigator's judgment, due to various medical, psychological, social or other conditions, it is contrary to the trial protocol or affects the subjects to sign informed consent. | COVID-19 | Adult group: Vaccine versus placebo group:0, 21, 42 days immunity;Elder group: Vaccine versus placebo:0, 21, 42 days immunity;Immunogenic subgroup group: Vaccine versus placebo:0, 21, 42 days immunity; | The incidence of adverse reactions (AR) 0-7 days after each immunization;The incidence of Adverse Events of Special Concern (AESI) from the first to 60 days after the last immunization; | | | | Yes | False | | |
| → | CTRI/2021/02/031451 | 23 March 2021 |
Immunogenicity Assessment Extension Study of nCoV-2019
novel coronavirus vaccine developed by Cadila Healthcare Ltd in
Phase I part of Protocol NCOV 1002.
|
Immunogenicity Assessment Extension Study OF Phase 1 Part
Of Protocol NCOV 1002
| | Cadila Healthcare Ltd | 22-02-2021 | 20210222 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52576 | Recruiting | No | | | | 22-02-2021 | 20 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | Phase 1 | India→ | Dr Ravindra Mittal→ | |
Zydus Corporate Park, Scheme No.
63, Survey No. 536, Nr. Vaishnodevi Circle, S.G. Highway,
Ahmedabad- 382481,Gujarat, India
→ | kevinkumarkansagra@zyduscadila.com→ | 02717665555→ | Cadila Healthcare Limited→ | Inclusion criteria: <br> 1.Subjects has completed the Phase 1 study (NCOV 1002) in treatment arms 3 & 4 (i.e. 2 <br/ ><br> mg vaccine) <br/ ><br> 2. Willing to participate and provide informed consent for the study<br> → | Exclusion criteria: <br> 1. Subjects who received another COVID vaccine after administration of last dose of <br/ ><br> vaccine in NCOV 1002. <br/ ><br> 2. Subjects having history of positive documented COVID-19 infection after completion <br/ ><br> of study in Phase I part of NCOV 1002<br> → | | <br> Intervention1: NOT APPLICABLE: NOT APPLICABLE<br> Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | <br> 1)Persistence of IgG antibodies titer in subjects after three months in treatment arms 3 & 4 (Arm3:2mg needle and Arm4:2mg Pharmajet) respectively and their comparison with the baseline within arms as well as between arms. <br/ ><br> <br/ ><br> 2)The proportion of subjects with detectable IgG antibodies titers persisted after three months in treatment arms 3 & 4 (Arm3:2mg needle and Arm4:2mg Pharmajet) respectively and their comparison with the baseline IgG antibodies titers.Timepoint: Week 22<br> → | | | | Yes | False | | |
| → | CTRI/2021/02/031430 | 23 March 2021 | Remdesevir and Hydroxychloroquine in moderate to severe Covid 19 patient. | Efficacy of Remdesevir and Hydroxychloroquine in moderate to severe COVID-19 patients admitted in the CCU of a tertiary care hospital in WestBengal,India. | | NIL | 22-02-2021 | 20210222 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47292 | Not Recruiting | No | | | | 24-02-2021 | 50 | Interventional |
Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded
→<br> Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded<br> | N/A | India→ | ASIM KUMAR KUNDU→ | |
Department of Anesthesiology
Green Building
3rd floor 88, COLLEGE STREET
KOLKATA
700073
→ | drslahiri11@gmail.com→ | 9830217131→ | MEDICAL COLLEGE KOLKATA→ | Inclusion criteria: <br> COVID RTPCR POSITIVE CASES <br/ ><br> PNEUNONITIS AS EFIDENT FROM CXR, HRCT THORAX <br/ ><br> REQUIRING OXYGEN VIA NRBM OR HIGHER SUPPORT LIKE HFNO,NIV OR INVASIVE VENTILATION<br> → | Exclusion criteria: <br> H/O DRUG ALLERGY TO ANY OF THE STUDY DRUGS <br/ ><br> H/O ADVERSE DRUG REACTION TO ANY OF THE STUDY DRUGS <br/ ><br> ELEVATED LIVER ENZYMES <br/ ><br> H/O OCCULAR DISEASE <br/ ><br> H/O CARDIO VASCULAR CONDUCTION DISEASE<br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: Remdesevir: One group will receive Remdesevir 200 mg iv day 1 followed by 100 mg iv day 2-5<br> Intervention2: Hydroxychloroquine: Another group will receive Hydroxychloroquine 400 mg orally twice daily on day 1 followed by 200 mg orally once daily day 2-5<br>→ | <br> AFEBRILE FOR 3 DAYS OR MORE <br/ ><br> RR 24/MIN OR LESS <br/ ><br> SPO2 94% OR MORE IN ROOM AIR <br/ ><br> NO RESPIRATORY DISTRESS, COUGH ETCTimepoint: 4 weeks<br> → | | | | Yes | False | | |
| → | CTRI/2021/02/031479 | 23 March 2021 | Effects of online Mindfulness program on Stress | Effect of an Online Mindfulness program on Stress in Indian Adults during COVID19 pandemic: A randomized controlled preliminary study to search for an alternative therapy | | HARMONY Meditation Center | 23-02-2021 | 20210223 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48898 | Not Recruiting | No | | | | 26-02-2021 | 90 | Interventional |
Randomized, Parallel Group Trial
Method of generating randomization sequence:Stratified randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
→<br> Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label<br> | N/A | India→ | anirban pal→ | |
43/6/5 jheel road 48/1F Leela Roy Sarani
Kolkata 700019
→ | pal.anirban1@gmail.com→ | | Apollo Gleneagles Medical centre→ | Inclusion criteria: access to electronic devices→ | Exclusion criteria: Previous experience of Mindfulness meditation→ | | <br> Intervention1: mindfulness: online meditation for 4 weeks with daily practice<br> Control Intervention1: wait listed: waiting<br>→ | perceived stress scoreTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/02/031484 | 23 March 2021 | Effectiveness of Holistic Traditional Complementary Alternative Medicine (HTCAM) on immuno, metabolic, clinical and psychosocial outcomes in suspected isolated cases of SARS CoV-2 : a Pilot Randomized Control Trial | Efficacy of customized protocols of Holistic Traditional Complementary Alternative Medicine (HTCAM) to implement for assessment and improvements of immuno, metabolic, clinical and psychosocial outcomes in suspected isolated cases of SARS CoV-2 for COVID-19 infection: a Pilot Randomized Control Trial | | Dst Satyam | 23-02-2021 | 20210223 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52585 | Not Recruiting | No | | | | 28-02-2021 | 100 | Interventional |
Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
→<br> Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label<br> | N/A | India→ | Dr Anissa Atif Mirza→ | | Department of biochemistry, Medical College Building, AIIMS Veerbhadra Marg, Pashulok, Rishikesh→ | anisabio@gmail.com→ | 8410116951→ | All India Institute of Medical Sciences→ | Inclusion criteria: <br> Suspected, Isolated admitted subjects for SARS COV-2 infection, clinically assigned score 4-8 as stable moderate dedicated to COVID Health Centre <br/ ><br> Age â?¥ 18 <br/ ><br> The patient who will be cooperative and want to participate in the study <br/ ><br> Not intake of any medications, herbs, or other complementary therapy in recent 8 weeks<br> → | Exclusion criteria: <br> Allergic or sensitive to any food item included in this study design <br/ ><br> Critical patients with comorbidities of metabolic, psychiatric, neurological illness, or autoimmune disorders <br/ ><br> Secondary malignancy <br/ ><br> On steroid therapy <br/ ><br> Patients very weak and unstable <br/ ><br> Pregnant women<br> → |
Health Condition 1: -
Health Condition 2: J069- Acute upper respiratory infection,unspecified
Health Condition 3: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 4: B975- Reovirus as the cause of diseasesclassified elsewhere
→ | <br> Intervention1: Under Behavioural therapy:: Hand Hygiene with soap and water 4 times per day,<br><br> Social or Physical Distancing should be maintained at least 2 metres,<br><br> Sleep: at least 8 hours of sound sleep.<br><br> Gargle with warm water, turmeric, and common salt 3 times per day,<br><br> All these procedures to be followed for 15 days<br> Intervention2: Under Physical therapy:: Yogasanas, Pranayama, Dhyna and Prayers should be performed every morning around 5 am for about 2 hours and in the evening at 7pm for about one and half hour. Total duration of the therapy is for 15 days.<br> Intervention3: Under Food additives category:: Hot Drinking water (250ml/ glass) at least 8 glass per day for 15 days.<br><br> Turmeric milk (Curcuma longa) 250 ml night time before sleep for 15 days.<br><br> Boiled Black seeds water (Kalonji; Nigella sativa L.)<br> 250 ml per day as oral intake for 15 days.<br><br> Almonds (Prunus dulcis) 8-10 per day orally for 15 days.<br><br> Jackfruit (Artocarpus heterophyllus)25 gm per day orally for 15 days.<br><br><br><br> Flax seeds (Linum usitatissimum) 5 gm per day orally for 15 days.<br><br> Jaggery/Guda, unrefined product of Saccharum officinarum 5 gm per day orally for 15 days.<br><br> Herbal tea contains Honey, Cloves (Syzygium aromaticum), Cinnamon bark<br> (Cinnamon zeylanicum) or<br> (Cinnamon cassia), Cardamom<br> (Amomum subulatun), Pepper<br> Black and White<br> (Piper nigrum L), Ginger<br> (Zingiber officinale Roscoe) 150 ml 2 times per day orally for 15 days.<br><br> Herbal paste contains Zeera<br> → | To implement holistic traditional natural complementary alternative medicine (HTNCAM) protocols based on hygiene, nutrition and mind-body-soul relaxation and assess immune, metabolic, clinical and psychosocial outcomes of pre and post interventions in Covid -19 suspects and isolated.Timepoint: until patient is discharged→ | | | | Yes | False | | |
| → | CTRI/2021/02/031472 | 23 March 2021 | A study to compare HRCT chest and RT PCR in identification of coronavirus disease 2019(COVID 19) | COMPARATIVE ANALYSIS OF HRCT CHEST AND RT PCR IN DETECTING CORONAVIRUS DISEASE 2019(COVID 19) | | Abhilash kusumba | 23-02-2021 | 20210223 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50600 | Not Recruiting | No | | | | 23-02-2021 | 180 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Abhilash kusumba→ | |
Columbia Asia referral hospital yeshwanthpur
26/4 brigade gateway beside metro malleshwaram Bengaluru Karnataka 560055
26/4 brigade gateway beside metro malleshwaram Bengaluru Karnataka 560055
→ | madhukumar.s@columbiaindiahospitals.com→ | 9739012131→ | Columbia Asia referral hospital yeshwanthpur→ | Inclusion criteria: <br> All patients with clinical symptoms and suspicion of covid-19 that are referred for chest CT to the radiology department at Columbia Asia referral hospital yeshwanthpur in Bangalore with positive RT PCR <br/ ><br> <br/ ><br> → | Exclusion criteria: <br> Patients with known interstitial lung diseases <br/ ><br> Pediatric population <br/ ><br> Uncooperative patients <br/ ><br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: HRCT CHEST:<br> This study is a cross-sectional study for comparative analysis of HRCT CT and RT PCR in detecting coronavirus disease 2019 (COVID-19) The primary outcome will be to study the validity of chest CT scan in diagnosing COVID-19 that is the sensitivity of diagnosing covid-19 with HRCT chest<br><br> Intervention2: NIL: NIL<br> Control Intervention1: RT PCR:<br> This study is a cross-sectional study for comparative analysis of HRCT CT and RT PCR in detecting coronavirus disease 2019 (COVID-19) The primary outcome will be to study the validity of chest CT scan in diagnosing COVID-19 that is the sensitivity of diagnosing covid-19 with HRCT chest<br><br> Control Intervention2: NIL: NIL<br>→ | From the reference literature review study ai et al (2020) has observed that the sensitivity of diagnosing covid-19 with HRCT chest was 97% In the present study expecting similar result with 95% confidence interval and 3% relative precision the study requires 180 subjectsTimepoint: 28th December 2020 till 30TH April 2022→ | | | | Yes | False | | |
| → | CTRI/2021/02/031520 | 23 March 2021 | A clinical study to see the effect of ArtemiC in patients with COVID-19 | A Phase II, Open label controlled clinical study designed to evaluate the effect of ArtemiC in patients diagnosed with COVID-19. | | MGC Pharmaceuticals Ltd | 24-02-2021 | 20210224 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52515 | Recruiting | No | | | | 25-02-2021 | 20 | Interventional |
Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable
→<br> Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable<br> | Phase 2 | India→ | Dr Neeta Nargundkar→ | |
Office No. 02, 03 & 04, Second Floor,
Highland Corporate Center,
Kapurbawdi Junction, Thane West
→ | pranjekar@gmail.com→ | 91-9823437353→ | Oz Innovative Solutions Pty Ltd→ | Inclusion criteria: <br> 1. Confirmed SARS-CoV-2 infection. <br/ ><br> 2. Age: 18 years old and above. <br/ ><br> 3. Subjects must be under observation or admitted to a controlled facility or hospital (home quarantine is not sufficient). <br/ ><br> 4. Ability to receive treatment by spray into the nasal cavity <br/ ><br> <br/ ><br> Cohort 1: <br/ ><br> 1.10 Patients clinically assigned as moderate [Presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 < 92% range 90-92% on room air, Respiratory Rate more or equal to 24 per minute] <br/ ><br> 2.Patients with a score of 4 (oxygen by mask or nasal prongs) on the 8- point ordinal scale of clinical status used by WHO at baseline assessment <br/ ><br> <br/ ><br> Cohort 2: <br/ ><br> 1.10 patients clinically assigned as severe (Clinical signs of Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 < 90% on room air) but not critically ill (acute respiratory distress syndrome [ARDS], multi organ failure or septic shock). <br/ ><br> <br/ ><br> 2.Patients with a score of 5 (Non-invasive ventilation or high flow oxygen) on the 8- point ordinal scale of clinical status used by WHO at baseline assessment. <br/ ><br> → | Exclusion criteria: <br> 1. Tube feeding or parenteral nutrition. <br/ ><br> 2. Critically ill patients, defined as those who are candidates for endotracheal intubation and invasive mechanical ventilation and those with ARDS, septic shock or multi-organ failure at baseline. <br/ ><br> 3. Uncontrolled diabetes type 2. <br/ ><br> 4. Autoimmune disease. <br/ ><br> 5. Pregnant or lactating women. <br/ ><br> 6. Any condition which, in the opinion of the Principal Investigator, would prevent full participation in this trial or would interfere with the evaluation of the trial endpoints. <br/ ><br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: ArtemiC medical spray with standard of care treatment: ArtemiC is a medical nasal spray combined of Artemisinin (6 mg/ml), Curcumin (20 mg/ml), Frankincense (15 mg/ml) and vitamin C (60 mg/ml) in spray administration. Patients will receive up to 12 mg Artemisinin, 40 mg Curcumin, 30 mg Frankincense and 120 mg vitamin C as a maximum dose per 24 hours, given as add-on therapy, 2 times a day, on Days 1 and 2.<br> Control Intervention1: Standard of care treatment: Standard of care treatment as per the clinical management protocol for COVID-19 followed by the Hospital<br>→ | <br> 1.Time to clinical improvement, defined as a national Early Warning Score 2 (NEWS2) of â?¤ 2 Maintained for 24 Hours in comparison to routine treatment. <br/ ><br> 2.Percentage of participants with definite or probable drug related adverse eventsTimepoint: 15 Days<br> → | | | | Yes | False | | |
| → | CTRI/2021/02/031523 | 23 March 2021 | Serum Creatinine and BUN in Covid 19 Hospitalised patients.â?? | â??Correlating the Serum Creatinine and BUN with the progression and fatality in Covid 19 Hospitalised patients: A Retrospective Study.â?? | | Self | 24-02-2021 | 20210224 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52370 | Not Recruiting | No | | | | 01-03-2022 | 100 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Dr Manjula K S→ | |
Department of Biochemistry
RRMCH
Bangalore
→ | manjunmurthy@gmail.com→ | 9743484774→ | Rajarajeswari medical college and hospital→ | Inclusion criteria: Covid-19 Positive patients confirmed by RT-PCR, admitted in RajaRajeswari Medical College and Hospital, Bengaluru.→ | Exclusion criteria: Any known case of Kidney disease→ |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: N178- Other acute kidney failure
→ | | Early and timely detection and proper management of these problems will help in reducing the morbidity and also prevents further complications.Timepoint: six months→ | | | | Yes | False | | |
| → | CTRI/2021/02/031521 | 23 March 2021 | Effect of COVID-19 pandemic on dental expenses of patients | The effect of COVID-19 pandemic on treatment costs incurred by the dental patients: A comparative study between two time periods | | Dr Deeksha Karkada | 24-02-2021 | 20210224 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50379 | Not Recruiting | No | | | | 28-02-2021 | 4000 | Observational |
Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable
→<br> Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable<br> | N/A | India→ | Dr Deeksha karkada→ | |
Room Number 8
Department of Public Health Dentistry
Manipal College of Dental Sciences, Manipal
→ | sh.acharya@manipal.edu→ | 9448127031→ | Manipal College of Dental Sciences→ | Inclusion criteria: The dental outpatient records for the months of February 2020 and October 2020→ | Exclusion criteria: Patients receiving treatment on an in-patient basis→ |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Total expenses in two time periodsTimepoint: Baseline, 8 months→ | | | | Yes | False | | |
| → | CTRI/2021/02/031570 | 23 March 2021 | Mindfulness for children | Online Mindfulness based intervention influences the Health-related Quality of life of Indian Children and Adolescent during COVID19 pandemic: A Randomized controlled Study | | ANIRBAN PAL | 25-02-2021 | 20210225 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53018 | Not Recruiting | No | | | | 28-02-2021 | 50 | Interventional |
Randomized, Parallel Group Trial
Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Investigator Blinded
→<br> Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Investigator Blinded<br> | N/A | India→ | ANIRBAN PAL→ | |
Apollo Gleneagles Medical Center, Department of Anaesthesia and Pain medicine
48/1F Leela Roy Sarani, Kolkata 19 Gariahat
→ | pal.anirban1@gmail.com→ | | Apollo Gleneagles Medical centre→ | Inclusion criteria: 8 to 14 years→ | Exclusion criteria: unable to understand English→ | | <br> Intervention1: mindfulness meditation: 8 week online mindfulness meditation program, conducted weekly<br> Control Intervention1: wait listed controls: wait listed participants, before and after 8 weeks<br>→ | 8 week health related quality of lifeTimepoint: 8 week→ | | | | Yes | False | | |
| → | CTRI/2021/02/031541 | 23 March 2021 | A study to evaluate the usefulness and side effects of injection Remdesivir in moderate to severe covid 19 lung affected patients in a multispeciality hospital in Kolkata. |
A study on the efficacy and adverse effects of Injection Remdesivir in moderate to severe SARS CoV-2 pneumonia in a tertiary care hospital in Kolkata.
| | nil | 25-02-2021 | 20210225 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52099 | Not Recruiting | No | | | | 27-02-2021 | 63 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | ANJAN CHATTOPADHYAY→ | | SAnaesthesiology dept Medical College Hospital Kolkata Anaesthesiology dept Medical College Hospital Kolkata→ | anjan.chat@gmail.com→ | 9831257338→ | Medical College Hospital Kolkata→ | Inclusion criteria: <br> 1. Age â?¥18 years at time of signing Informed Consent Form <br/ ><br> 2. Laboratory (RT-PCR) confirmed COVID-19. <br/ ><br> 3. Lung involvement confirmed with chest imaging <br/ ><br> 4. Hospitalized with a SaO2/SPO2â?¤94% on room air or Pa02/Fi02 ratio <300mgHg <br/ ><br> 5. â?¤12 days since illness onset <br/ ><br> 6. Have given consent to participate in the study. <br/ ><br> → | Exclusion criteria: <br> 1. Severe liver disease (e.g. Child Pugh score â?¥ C, AST >5 times upper limit) <br/ ><br> 2. Pregnant or breastfeeding, or positive pregnancy test in a pre dose examination <br/ ><br> 3. Patients with known severe renal impairment (estimated glomerular filtration rate â?¤30 mL/min/1.73 m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis <br/ ><br> 4. Receipt of any experimental treatment for COVID-19 within the 30 days prior to the time of the screening evaluation. <br/ ><br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: B338- Other specified viral diseases
Health Condition 4: J168- Pneumonia due to other specified infectious organisms
→ | | <br> 1. Time to Clinical Improvement (TTCI) [Censored at Day 28] [ Time Frame: up to 28 days ] <br/ ><br> Defined as the time (in days) from starting of study treatment (Remdesivir) along with the standard of care until a decline of two categories on a Six category ordinal scale of clinical status (1 ê?? discharged; 6 ê?? death) or live discharge from hospital. <br/ ><br> <br/ ><br> Timepoint: 1. Time to Clinical Improvement (TTCI) [Censored at Day 28] [ Time Frame: up to 28 days ] <br/ ><br> Defined as the time (in days) from starting of study treatment (Remdesivir) along with the standard of care until a decline of two categories on a Six category ordinal scale of clinical status (1 ê?? discharged; 6 ê?? death) or live discharge from hospital. <br/ ><br> <br/ ><br> → | | | | Yes | False | | |
| → | CTRI/2021/02/031566 | 23 March 2021 | Evaluation of Equine antibody treatment in patient with COVID 19 infection | A Prospective, Randomized, Multi-center, Open label, Phase 1/2 study to Evaluate the Safety and Efficacy of Equine COVID-19 Antiserum [F(ab)2] (BSVEQAb) plus Standard of Care in Comparison to Standard of Care alone in COVID-19 RT-PCR positive Patients (PROTECT) - PROTECT | | Bharat Serums and Vaccines ltd | 25-02-2021 | 20210225 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51849 | Not Recruiting | No | | | | 15-03-2021 | 160 | Interventional |
Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable
→<br> Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable<br> | Phase 1/ Phase 2 | India→ | Anirban Roy Chowdhury→ | |
Address 3rd floor, Liberty tower, Behind Reliable Plaza, Airoli, Navi mumbai
→ | anirban.roychowdhury@bharatserums.com→ | 022-45043456→ | Bharat serums and Vaccines LTd→ | Inclusion criteria: <br> 1. Age <br/ ><br> Phase 1: â?¥ 18 years to â?¤ 55 years <br/ ><br> Phase 2: â?¥ 18 years to â?¤ 65 years <br/ ><br> 2. Are male or non-pregnant females who agree to contraceptive requirements. <br/ ><br> 3. Patients with RT-PCR confirmed COVID-19 in â?¤ 72 hours prior to randomization [Ct â?¥ 24]. <br/ ><br> 4. Have SpO2 <94% (range 90-93%) on room air. <br/ ><br> 5. Have one or more of the following- dyspnea, fever, cough, respiratory rate â?¥ 24 per minute and heart rate up to 120 per minute. <br/ ><br> 6. Patients who agree to participate in the study and follow all study related procedures<br> → | Exclusion criteria: <br> 1. Require mechanical ventilation <br/ ><br> 2. Have oxygen saturation less than or equal to 89 percent <br/ ><br> 3. Patients re-infected with SARS-CoV-2 <br/ ><br> 4. Suspected or proven serious active bacterial fungal viral or other infection <br/ ><br> 5.Patients with positive skin test with IP <br/ ><br> 6. Patients with known equine allergies or past medical history of serum sickness <br/ ><br> 7. Patient who are HIV, HCV, HbsAg positive or immunocompromised <br/ ><br> 8. Patients with significant co-morbidities at screening <br/ ><br> 9. Moribund state <br/ ><br> 10. Pregnant or nursing women <br/ ><br> 11. Participating in other clinical trial<br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: Equine COVID-19 Antiserum [F(ab)2] (BSVEQAb)<br> Along with Standard of care.: Dose of BSVEQAb - 5 mg/kg or 10 mg/kg body weight.<br> It is administered as a single dose intravenously after diluting in 100 -150 ml saline. The infusion will be done over 1 to 2 hours.<br> Standard of care for treatment of COVID-19 positive patients<br> Control Intervention1: Standard of Care: Treatment as per current treatment guidelines and institutes practice for COVID-19 positive patients will be administered<br>→ | <br> Phase 1 <br/ ><br> Number of patients with one or more unexpected serious adverse event(s) (SAEs) considered by the investigator to be related to study drug administration <br/ ><br> <br/ ><br> Phase 2 <br/ ><br> Proportion (percent) of patients turning COVID-19 negative Day 5 and Day 7Timepoint: Phase 1 <br/ ><br> Baseline through Day 28 <br/ ><br> <br/ ><br> Phase 2 <br/ ><br> Day 5 and Day 7<br> → | | | | Yes | False | | |
| → | CTRI/2021/02/031547 | 23 March 2021 | A clinical trial to induce immunity and herd immunity against viruses including covid 19 |
Broad Spectrum Antiviral Prophylactic Unani Medicine to Induce Immunity and Herd immunity based on empirical evidence of unani system of medicine
- BSAPUM | | Dr Hashmis Unani Medcine Observation Research Foundation | 25-02-2021 | 20210225 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43929 | Recruiting | No | | | | 25-02-2021 | 50 | Interventional |
Other
Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Participant Blinded
→<br> Other<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Participant Blinded<br> | Phase 2 | India→ | Dr Syed Mujtaba Ali Hashmi→ | | H.No.19-4-346/2 Konda Reddy Guda Kishan Bagh Hyderabad H.No.19-4-346/2 Konda Reddy Guda Kishan Bagh Hyderabad→ | dr_s_mujtabaali@yahoo.com→ | 9885828079→ | Dr. Hashmis Unani Medicine Observation & Research Foundation→ | Inclusion criteria: age group 9 to 80 years male and female with normal vitals and blood sugar→ | Exclusion criteria: below 9 years, between mensuration in females and pregnancy in females→ | | <br> Intervention1: Aleo secondry metabolites like,Anthraqunones,Anthrones,Furan derivatives,Chromones,Cumatins,Flavonids,Phytosterols,Pyrans and pyrones,Organic and Inorganic constituents of Myrrah resin,Volatile and ninvolatile compounds of Saffron.: Aloe Vera --------------2mg.<br> Commiphora Myrrah-------1mg.<br> Saffron-----------------1mg.<br> 4mg. tablets<br> aquas extract of Rosa Damascena<br> Dose<br> 9yars to 14 years 2mg.with 5ml rose water once a day<br> 15years to 20years 4mg with 10ml rose water once a day<br> 20 years to 80 years 4mg morning and evening with 30ml rose water<br><br> Intervention2: extracts of<br> Aloe vera --------------2mg<br> Commiphora myrrah-------img<br> Saffron-----------------1mg<br> aquas extract of<br> Rosa Damascena--------20ml: 9Yrs to 14Yrs---2mg tab once a day with 5ml rose water for 60 days<br> 15Yrs to 20Yrs---4mg onca day with 10ml rose water for 60 days<br> 21Yrs to 90Yrs---4mg two time a day with<br> 20ml rose water for 60 days<br> Intervention3: extracts of Aloe vera --------------2mg Commiphora myrrah-------img Saffron-----------------1mg aquas extract of Rosa Damascena--------20ml : 9Yrs to 14Yrs---2mg tab once a day with 5ml rose water for 60 days 15Yrs to 20Yrs---4mg onca day with 10ml rose water for 60 days 21Yrs to 90Yrs---4mg two time a day with 20ml rose water for 60 days<br> Control Intervention1: not applicable: not applicaple<br>→ | stress levels willbe reduced, frequency of cold effects will be reduced, tummy troubles (constipation and indigestion issues) will be reduced and feeling of triedness will be reducedTimepoint: 0 to 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/02/031543 | 23 March 2021 | COVID-19 Pandemic- Impact of online yoga on mental health and quality of life in adolescents | COVID-19 Pandemic- Impact of tele yoga on mental health and quality of life in adolescents | | Arun Thulasi | 25-02-2021 | 20210225 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52892 | Not Recruiting | No | | | | 11-03-2021 | 500 | Interventional |
Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Vikas Rawat→ | |
Division of Yoga & Humanities,
SVYASA Yoga University,
Swami Vivekananda Road, Kalluballu Post,
Anekal, Jigani,
Karnataka
→ | vikasrawat.svyasa@gmail.com→ | 6362805583→ | Swami Vivekananda Yoga Anusandhana Samsthana→ | Inclusion criteria: <br> 1. School children between the age group of 12-18 years <br/ ><br> 2. Children fluent in English or Malayalam languages <br/ ><br> 3. Both males and females <br/ ><br> 4. Children & parents consenting to participate in the study <br/ ><br> 5. Children having access to a smartphone or electronic device with internet connectivity <br/ ><br> → | Exclusion criteria: <br> 1.Children with ongoing acute illness or those with a history of chronic illness in the preceding six months <br/ ><br> 2.Children with visual, hearing & speech disabilities <br/ ><br> 3.Children practicing yoga or any other similar practices while staying at home during the last 3 months <br/ ><br> → | | <br> Intervention1: Tele Yoga: Online yoga would be taught to school children in the intervention group that would consist of practices like loosening practices, Surya Namaskara, Asanas, Pranayama and relaxation.<br> Control Intervention1: Online Physical Exercises: Standard physical exercises will be provided to the control group comprising of routine exercises and games that can be done at home.<br>→ | <br> 1.To conduct a survey to assess the mental health and Health related Quality Of Life (HRQOL) in school children and its implications on parents in Kerala due to the current COVID-19 home confinement <br/ ><br> 2.To assess the efficacy of tele yoga for mental health and Health Related Quality Of Life (HRQOL) in school children during home confinementTimepoint: Strengths and Difficulties Questionnaire Time-point: 8 and 12 weeks <br/ ><br> WHOQOL-BREF Time-point: 8 and 12 weeks<br> → | | | | Yes | False | | |
| → | CTRI/2021/02/031554 | 23 March 2021 | The study to check the safety and immune response of (Covid-19 vaccine) COVOVAX in adults |
A phase 2/3, observer-blind, randomized, controlled study to determine the safety and immunogenicity of COVOVAX [SARS-CoV-2 recombinant
spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1â?¢ adjuvant] in Indian adults
- ICMR/SII-COVOVAX | | Serum Institute of India Private Limited Pune | 25-02-2021 | 20210225 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49327 | Not Recruiting | No | | | | 26-02-2021 | 1600 | Interventional |
Other
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
→<br> Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded<br> | Phase 2/ Phase 3 | India→ | Dr Prasad Kulkarni→ | |
Serum Institute of India Private Limited
212/2, Hadapsar, Pune â?? 411 028, India
→ | drpsk@seruminstitute.com→ | 00912026602949→ | Serum Institute of India Private Limited→ | Inclusion criteria: <br> 1. Adults aged more than or equal to 18 years of either sex <br/ ><br> 2. Written informed consent by participants <br/ ><br> 3. The participant is resident of the study area and is willing to comply with study protocol requirements <br/ ><br> 4. Healthy, as determined by medical history and physical examination <br/ ><br> 5. Sexually active female participants of childbearing potential must have practiced adequate contraception for 28 days prior to study vaccine administration and agree to continue adequate contraception until completion of their Day 36 visit <br/ ><br> 6. Female participants of childbearing potential must have a negative <br/ ><br> urine pregnancy test within 24 hours prior to study vaccine<br> → | Exclusion criteria: <br> 1. Acute illness including COVID-19 with or without fever at the time of study vaccine administration <br/ ><br> 2. History of laboratory confirmed (by PCR or serology to SARSCoV-2) COVID-19 disease. <br/ ><br> 3. History of severe allergic reactions after previous vaccinations or hypersensitivity to any component of study vaccines <br/ ><br> 4. Prior receipt of an investigational or licensed vaccine likely to <br/ ><br> impact interpretation of the trial data <br/ ><br> 5. Current or planned participation in prophylactic drug trials for the <br/ ><br> duration of the study <br/ ><br> 6. Prior receipt of an investigational or licensed vaccine likely to impact interpretation of the trial data <br/ ><br> 7. Prior receipt of a COVID-19 vaccine or planning to receive a COVID-19 vaccine during the course of the study. <br/ ><br> 8. Pregnant or breast-feeding <br/ ><br> 9. Individuals who are part of study team or close family members of individuals conducting this study<br> → | | <br> Intervention1: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1â?¢ adjuvant]: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle<br> vaccine (SARS-CoV-2 rS) with Matrix-M1â?¢ adjuvant] is available as a<br> ready to use liquid formulation in a vial containing 5 mcg antigen and 50 mcg<br> Matrix-M1 adjuvant.<br> Each dose of 0.5 ml (5 mcg antigen and 50 mcg<br> Matrix-M1 adjuvant) will be given intramuscularly on deltoid on Day 1 and Day 22 as per randomization.<br> Manufacturer: Serum Institute of India Pvt. Ltd. (SIIPL).<br> Control Intervention1: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine<br> (SARS-CoV-2 rS) with Matrix-M1â?¢ Adjuvant: Novavax-SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine<br> (SARS-CoV-2 rS) with Matrix-M1â?¢ Adjuvant is available as a ready to<br> use liquid formulation in a vial containing 5 mcg antigen and 50 mcg Matrix-<br> M1 adjuvant.<br> Each dose of 0.5 ml (5 mcg antigen and 50 mcg Matrix-M1 adjuvant) will be given intramuscularly on deltoid on Day 1 and Day 22 as per randomization.<br> Manufacturer: Novavax, USA<br> Control Intervention2: Placebo: Placebo: 0.9%<br> Normal saline (Sodium chloride) for injection. Each dose of 0.5 ml will be given intramuscularly on deltoid on Day 1 and Day 22 as per randomization.<br>→ | <br> Occurrence of causally related serious <br/ ><br> adverse events (SAEs) throughout the study duration following vaccinationTimepoint: Day 36, 85, 180<br> → | | | | Yes | False | | |
| → | CTRI/2021/02/031545 | 23 March 2021 | This is a comparison study between perceived comfort, acceptability and efficiency between low cost loose fitting PAPR and PPE ( full body PPE, along with N95 mask, goggles, and also a face shield in the front) | Usability study on the Powered Air Purifying Respirator (PAPR) with AIMS medical staff | | Amrita Vishwa Vidyapeetham | 25-02-2021 | 20210225 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52734 | Not Recruiting | No | | | | 01-03-2021 | 20 | Observational |
Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Ayyappan A→ | | AMMACHI Labs (Amrita Multi Modal Applications and Human Computer Interaction), Amrita Vishwa Vidyapeetham ,Amritapuri, Clappana, OACHIRA, KERALA, 690525, India → | ayyappan.ajan@ammachilabs.org→ | 9188370785→ | AMMACHI Labs→ | Inclusion criteria: Full time health worker (Nurse/ doctor)→ | Exclusion criteria: Other than nurses/doctors→ | | <br> Intervention1: PAPR: AMMACHI Labs attached to Amrita Vishwa Vidyapeetham has developed a low cost<br> Powered Air Purifying Respirator (PAPR), costing less than Rs. 30,000 which can be safely used by frontline health workers attending COVID wards.<br> Intervention2: Nil: Nil<br> Control Intervention1: PPE(N-95 mask)along with full body suit: PPE(N-95 mask) along with full body suit during the daily routines nurse/doctor<br> Control Intervention2: Nil: Nil<br>→ | Differences in perceived comfort, acceptability and efficiency between Low cost loose fitting PAPR and PPE ( full body PPE, along with N95 mask, goggles, and also a face shield in the front)Timepoint: Task assigned for 3 hours per day for the nurse/doctor while wearing PAPR/PPE→ | | | | Yes | False | | |
| → | CTRI/2021/03/031616 | 23 March 2021 | Concordance Between Buccal Cavity Swab and Nasopharyngeal Swab for SARS-CoV-2 (COVID-19) Detection by RT-PCR and ELISA | Evaluating the Use of Flavour-Stimulated Oral Fluids Collection for Severe Acute Respiratory Syndrome Coronavirus 2 Detection by Reverse Transcriptase Polymerase Chain Reaction and Enzyme Linked Immunosorbent Assay - a Concordance Study. | | Datar Cancer Genetics | 01-03-2021 | 20210301 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52784 | Not Recruiting | No | | | | 05-03-2021 | 300 | Observational |
Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Dr Vineet Datta MD FRCP→ | |
Department of Research and Innovations,
Suite 29,
F-8, D Road,
MIDC Ambad,
Nasik
→ | drvineetdatta@datarpgx.com→ | 00919911110457→ | Datar Cancer Genetics→ | Inclusion criteria: <br> 1. Known COVID-19 positive by RTPCR (with active infection) <br/ ><br> OR <br/ ><br> Known COVID-19 negative by RTPCR (tested within 7 days) <br/ ><br> 2. Provision of Informed Consent <br/ ><br> 3. Willing to provide Nasopharyngeal Swab as well as Buccal Cavity Swab<br> → | Exclusion criteria: <br> 1. Pediatric patients. <br/ ><br> 2. Inability to provide Informed Consent. <br/ ><br> 3. Inability to provide Nasopharyngeal Swab and / or Buccal Cavity Swab. <br/ ><br> 4. Other conditions: allergic to latex. <br/ ><br> 5. Diagnosed with psychological conditions that restrict ability to comply with study procedures; <br/ ><br> 6. Prisoners and pregnant women <br/ ><br> 7. Subjects with pathologies relating to dental, oral and salivary conditions. <br/ ><br> 8. Subjects with allergies related to the components used in the kit. <br/ ><br> 9. Any other condition as judged by the PI which will restrict the ability to participate in the study and / or comply with study procedures.<br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Concordance between COVID19 status as determined by buccal cavity swab and contemporary nasal swab, respectively.Timepoint: Baseline (Day 0)→ | | | | Yes | False | | |
| → | CTRI/2021/03/031615 | 23 March 2021 | Knowledge, Attitude and Practice (KAP) in regard to COVID-19 patients | Assessment of Knowledge, Attitude and Practice (KAP) in regard to COVID-19 in patients with chronic conditions | | KBIPER | 01-03-2021 | 20210301 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53060 | Recruiting | No | | | | 02-03-2021 | 400 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Roshni Patel→ | |
KBIPER K B Institute of Pharmaceutical Education and Research
Sector 23, Gandhinagar
→ | shrikalp@gmail.com→ | 09427774447→ | KBIPER→ | Inclusion criteria: <br> Age >65 years. <br/ ><br> Gender: both (Male and female). <br/ ><br> Patient with chronic conditions. <br/ ><br> Patient willing to give consent to the study. <br/ ><br> → | Exclusion criteria: <br> â?¢Patients with COVID-19. <br/ ><br> â?¢Patient with dementia or psychiatric disorder. <br/ ><br> → |
Health Condition 1: G- Mental Health
Health Condition 2: E70-E88- Metabolic disorders
→ | <br> Intervention1: Observational Study: NIL<br>→ | Knowledge, Attitude and practice towards COVID-19Timepoint: Baseline Only→ | | | | Yes | False | | |
| → | CTRI/2021/03/031614 | 23 March 2021 | Comparative study of two types of steroids for severe COVID disease | A retrospective comparative study of methylprednisolone versus dexamethasone in patients with severe COVID disease admitted to intensive care unit | | VMMC AND Safdarjung HospitalDelhi | 01-03-2021 | 20210301 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52090 | Not Recruiting | No | | | | 01-03-2021 | 200 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Anjali Kochhar→ | | Department of anaesthesia,VMMC and Safdarjung Hospital,Delhi → | kochharanjali0@gmail.com→ | 01126198462→ | VMMC and Safdarjung Hospital,Delhi→ | Inclusion criteria: <br> All RT-PCR confirmed COVID 19 positive patients severe COVID-19 disease, <br/ ><br> who have received steroid therapy (methylprednisolone or dexamethasone)<br> → | Exclusion criteria: <br> 1. Patients on chronic steroid therapy <br/ ><br> 2. Patients having Cushing syndrome <br/ ><br> 3. Patients on chemotherapy or immunosuppressive drugs <br/ ><br> 4. Post-operative patients <br/ ><br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | <br> 1. Oxygenation ratio (PaO2/FiO2 ratio) <br/ ><br> 2. Level of biomarkers(IL-1,IL-6,ferritin,TNF-a ) <br/ ><br> 3. Need for mechanical ventilation <br/ ><br> 4. duration of ICU stay <br/ ><br> 5. 30 day mortality <br/ ><br> Timepoint: 30 days<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031617 | 23 March 2021 | â??Study of sequential antibody estimation post COVID-19 vaccination amongst health care workersâ?? | â??Study of sequential antibody estimation post COVID-19 vaccination amongst health care workersâ?? | | Janakpuri Super Speciality Hospital Society | 01-03-2021 | 20210301 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53164 | Not Recruiting | No | | | | 05-03-2021 | 70 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Priyanka Banerjee→ | |
Janakpuri Super Speciality Hospital Society.
Department of Microbiology
1st Floor Room no. 125
C2B Janakpuri
New Delhi 110058 Janakpuri Super Speciality → | banerjepriyanka@gmail.com→ | 09958671066→ | Janakpuri Super Speciality Hospital Society→ | Inclusion criteria: HCWs of JSSHS, irrespective of age and gender who has received COVID-19 vaccination.→ | Exclusion criteria: â?¢ Any contradiction to venipuncture→ | | | <br> Expected outcome: <br/ ><br> 1. Effectivity of vaccine estimated by post vaccination seropositivity rate. <br/ ><br> 2. The duration of persistance of antibodies post vaccination will be aasessed during the stipulated study period. <br/ ><br> 3. Will be able to compare antibody detection in people previously infected and non infected with SARS-CoV2Timepoint: 1. Post vaccination seropositivity rate more than 70% <br/ ><br> 2. Duration of persistence of antibodies more than 3 months<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031663 | 23 March 2021 | Complete Blood Count as screening tool for COVID-19 | White Blood Cell Scattergrams in COVID-19 patients â?? a rapid screening tool? | | Pramukhswami Medical College | 02-03-2021 | 20210302 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53270 | Not Recruiting | No | | | | 08-03-2021 | 1000 | Observational |
Randomized, Parallel Group Trial
Method of generating randomization sequence:Other Method of allocation concealment:Case Record Numbers Blinding and masking:Investigator Blinded
→<br> Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Case Record Numbers Blinding and masking:Investigator Blinded<br> | N/A | India→ | Dr Mustafa Ranapurwala→ | | 112,Hematology and Clinical Pathology section, Central Diagnositc Centre, First Floor, Main Building, Shree Krishna Hospital,→ | dr.mustafa.r@gmail.com→ | 09898982709→ | Pramukhswami Medical College, Bhaikaka University, Karamsad, GUJ,IN.→ | Inclusion criteria: RAT and/or RT-PCR positive COVID â?? 19 patients in whom haemogram was ordered.→ | Exclusion criteria: <br> Suspected COVID â?? 19 patients, who tested negative with either RAT or RT- PCR. <br/ ><br> <br/ ><br> COVID â?? 19 patients in whom haemogram was not ordered. <br/ ><br> → |
Health Condition 1: J100- Influenza due to other identifiedinfluenza virus with pneumonia
→ | <br> Intervention1: NIL: NIL<br> Control Intervention1: NIL: NIL<br>→ | Specific pattern of sandglass pattern in COVID-19 patientsTimepoint: at baseline→ | | | | Yes | False | | |
| → | CTRI/2021/03/031665 | 23 March 2021 | Ivermectin prophylaxis for Covid-19 Infection in Health care Personnel | Efficacy and Safety of Ivermectin prophylaxis for Covid-19 Infection in Health care Personnel: A Randomized Controlled Clinical Trial | | AIIMS Rishikesh | 02-03-2021 | 20210302 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53325 | Not Recruiting | No | | | | 15-03-2021 | 50 | Interventional |
Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded
→<br> Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded<br> | Phase 4 | India→ | Dr Manisha Bisht→ | |
Dept of Pharmacology
AIIMS Rishikesh
→ | manishabisht@yahoo.co.in→ | 8475000263→ | AIIMS Rishikesh→ | Inclusion criteria: <br> 1. Health care personnel (HCP) >18 years age <br/ ><br> 2. HCP identified as primary contact and have High Risk defined as per ICMR guidelines for contracting COVID-19 infection <br/ ><br> 3. HCP who have not presented with general symptoms such as general discomfort, fever, cough, dyspnoea or muscle pain in the last week. <br/ ><br> 4. HCP who are willing to give written informed consent <br/ ><br> → | Exclusion criteria: <br> 1. Already infected with SARS-cov-2/ previous COVID-19 within the last 6 months <br/ ><br> 2. HCW who have taken any medication as possible prophylaxis for COVID-19 <br/ ><br> 3. Pregnancy <br/ ><br> 4. Prior enrolment into this or other COVID-19 prevention or treatment trials. <br/ ><br> 5. HCW with known allergy to ivermectin <br/ ><br> → | | <br> Intervention1: Ivermectin Tablets<br> : Ivermetin-200 mcg / kg two doses - 72 hours apart<br> [ 40-60 kg : 12 mg; 60 -80 kg :18 mg; 80 kg : 24 mg]<br> Control Intervention1: Vit C: Vitamin C 1000mg Once daily for 14 days<br>→ | RT- Polymerase chain reaction (PCR) confirmed SARS-CoV-2 infection [ Day 10]- As per State covid management guidelinesTimepoint: Day 10→ | | | | Yes | False | | |
| → | CTRI/2021/03/031668 | 23 March 2021 | Adi five layered designer cotton face mask with filter | Use of five layered Adiâ??s cotton face mask with a filter and its commercial application during and after Covid-19 | | Dr Aditya K Agrawal | 02-03-2021 | 20210302 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52317 | Not Recruiting | No | | | | 17-02-2021 | 10 | Observational |
Randomized, Parallel Group, Multiple Arm Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Investigator Blinded
→<br> Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Investigator Blinded<br> | Phase 3 | India→ | Aditya Agrawal→ | |
Department of Orthopaedics
Shrimati Bhikiben Kanjibhai Shah Medical Institute and Research Centre
Sumandeep Vidyapeeth An Institution to be Deemed Piparia Waghodia Vadodara
→ | adityagrawal83@gmail.com→ | | Shrimati Bhikiben Kanjibhai Shah Medical Institute and Research Centre→ | Inclusion criteria: Participants of age 18-40 years with no co-morbidities→ | Exclusion criteria: participants who were not willing for the study or anyone having cough, cold or fever→ | | <br> Intervention1: Adis 5 layered cotton face mask with filter: The Adiâ??s five layered cotton face mask is made primarily by four folds of a gentâ??s large size 15â?? x 6â?? handkerchief. The four straps on the sides of the rectangular face mask are also made of cotton fabric. There are two layers in the front and one layer in the back stitched in all sides except one on the right side. In between, we can put a double layered folded tissue paper, HEPA filter or poly-microurathene sponge material between the second and third layer of the mask.<br> Control Intervention1: N95 mask: was used as one of the comparator<br> Control Intervention2: surgical mask: on of the comparator<br> Control Intervention3: no mask: control<br>→ | Adis face mask is equivalent to N-95 face maskTimepoint: 48hrs→ | | | | Yes | False | | |
| → | CTRI/2021/03/031664 | 23 March 2021 | Open Label Study to Evaluate the Safety and Efficacy of SwasVimochan, SwasanRakshak, Swasamrit, Immune Energy Tablets with Mild to Moderate COVID-19 Patients | A randomized, Open Label, Standard controlled,2-Arm,prospective study to investigate the safety and efficacy of the SwasVimochan,SwasanRakshak,Swasamrit,Immune Energy Tablets in Mild to Moderate COVID-19 patients. | | Someshwar Cosmic Energy Research Center | 02-03-2021 | 20210302 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52574 | Not Recruiting | No | | | | 08-03-2021 | 60 | Interventional |
Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
→<br> Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label<br> | N/A | India→ | Mukul Maurya→ | | ProClin Research Private Limited. Second Floor,IT Tower Plot No 29,Sector 142 Noida→ | rohitparate963@gmail.com→ | 9630033342→ | Chirayu Medical College and Hospital→ | Inclusion criteria: <br> Subject will be included in the study if they meet all of the following criteria: <br/ ><br> 1. Provides written informed consent. <br/ ><br> 2. Male or non-pregnant, non-lactating female aged > 18 and < 75 years (both inclusive) <br/ ><br> 3. RT-PCR confirmed diagnosis of COVID-19. <br/ ><br> 4. Finger Oxygen saturation 88 to 92% in rest state. <br/ ><br> 5.Able to take the drug orally and comply with study procedures. <br/ ><br> 6. Women of childbearing potential must have a negative urine pregnancy test prior to study entry.<br> → | Exclusion criteria: <br> Patient with severe to critical type of health condition as stratified below: <br/ ><br> Clinical stratification: <br/ ><br> Severe type : meeting any of the following criteria: <br/ ><br> Respiratory distress, RR >30 times/min; <br/ ><br> Critical type:meeting any of the following criteria: <br/ ><br> a) Respiratory failure occurs and mechanical ventilator is required. <br/ ><br> b) Patients go into shock. <br/ ><br> c) ICU is needed for other organ failure. <br/ ><br> Other viral pneumonia. <br/ ><br> 1.Patients on anticoagulant (such as aspirin, Wasfarin , heparine etc.) ( Note : patient who need anticoagulant added to their SOC regimen as per the discreation of the treating physician will be withdrawn from the study) <br/ ><br> 2.Patient who have recived tumor immunotherapy ( such as PD-1/L1,CTLA4, etc.) in the past 1 month, and inflammation factor modulator such as Ulinastatin. <br/ ><br> 3.patient who have received organ transplantation or surgery planning in the past 6 month. <br/ ><br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: SwasVimochan,SwasanRakshak,Swasamrite,ImmuneEnergyTablets: SwasVimochan(BD),SwasanRakshak(BD),Swasamrite(BD),ImmuneEnergy(TID) for 07 days<br> Control Intervention1: Standard of care: Standard of care as per institutional practice<br>→ | <br> 1) Proportion of patients showing clinical improvement. <br/ ><br> 2)Improvement in Weakness. <br/ ><br> 3)Improvement in SpO2 Levels. <br/ ><br> 4)Time to first negative SARS-CoV-2 RT-PCR. <br/ ><br> 5)Duration of hospitalization. <br/ ><br> 6) Duration of supplemental oxygen therapy. <br/ ><br> 7) Time to Normalization of Symptoms.Timepoint: 1) Proportion of patients showing clinical improvement Clinical improvement.Day 5, 9 and Upto Day 21. <br/ ><br> 2)Improvement in Weakness.Up to 3 Weeks (21 Days). <br/ ><br> 3)Improvement in SpO2 Levels. Up to 3 Weeks (21 Days). <br/ ><br> 4)Time to first negative SARS-CoV-2 RT-PCR.Day 5, 9 and Upto 21 Days. <br/ ><br> 5)Duration of hospitalization. Upto 3 Weeks. <br/ ><br> 6) Duration of supplemental oxygen therapy, Upto 3 Weeks. <br/ ><br> 7) Time to Normalization of Symptoms, Upto 3 Weeks.<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031667 | 23 March 2021 | Effect of Chatushashti Prahari Pippali in the management of Post COVID syndrome | Prospective double arm placebo controlled clinical study to evaluate the efficacy of â??Chatushashti Prahari Pippaliâ?? in the management of Post COVID syndrome as Rasayana therapy | | Institute of Teaching and Research in Ayurveda | 02-03-2021 | 20210302 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53117 | Not Recruiting | No | | | | 25-03-2021 | 80 | Interventional |
Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
→<br> Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label<br> | Phase 3 | India→ | Dr Mandip Goyal→ | | Department of Kayachikitsa, Institute of Teaching and Research in Ayurveda, Jamnagar → | mandipgoyal22@gmail.com→ | 9427572306→ | Institute of Teaching and Research in Ayurveda, Jamnagar→ | Inclusion criteria: <br> 1. Patients willing to comply with all study procedures and availability for the duration of the study <br/ ><br> 2. Documented prior COVID-19 infection as evidenced by: <br/ ><br> a. Detection of SARS-CoV-2 RNA or antigen in nasopharyngeal swab, sputum, or other sample source or <br/ ><br> b. A positive antibody test using an assay that has received emergency use authorization and a history of clinical manifestation compatible with COVID-19. <br/ ><br> 3. Patients having two negative tests after previous COVID infection but having lingering symptoms of the disease <br/ ><br> → | Exclusion criteria: <br> 1. Positive SARS-CoV-2 PCR at the screening visit <br/ ><br> 2. Patients having severe symptoms of Post COVID 19 syndrome with co-morbidities requiring hospitalization <br/ ><br> 3. History of any of the following in the past 14 days: fever > 38.2 degrees Celsius; new or worsening respiratory symptoms (e.g. cough, dyspnea) <br/ ><br> 4. Patients having uncontrolled cardiac, renal, hepatic disease, malignancy, AIDS <br/ ><br> 5. Pregnant and lactating women <br/ ><br> 6. Patients taking phenytoin, propranolol, theophylline (as Pippali has moderate interaction with the absorption of these drugs) <br/ ><br> 7. Patients having or progressive towards serious sequelaesuch as thromboembolic complications <br/ ><br> 8. COVID-19 patients whose acute illness required intensive care <br/ ><br> 9. SpO2 < 92 <br/ ><br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B998- Other infectious disease
→ | <br> Intervention1: Chatushashti Prahari Pippali along with Rehabilitation program by WHO: In group A patients will be treated with capsules of Chatushashti Prahari Pippali 500 mg BD along with Rehabilitation program by WHO for the duration of two months<br> Control Intervention1: Placebo capsules along with Rehabilitation program by WHO: In group B patients will be treated with the capsules of placebo 500 mg BD along with Rehabilitation program by WHO for the duration of two months<br>→ | Improvement in the symptoms of Post COVID syndromeTimepoint: 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/03/031669 | 23 March 2021 | Impact of coronavirus on acute appendicitis and its clinicopathological factors in children | Impact of SARS CoV-2 Virus on Acute appendicitis in children - A retrospective study | | Debashri Shankarraman | 02-03-2021 | 20210302 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52126 | Not Recruiting | No | | | | 06-03-2021 | 60 | Observational |
Other
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
→<br> Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label<br> | N/A | India→ | Debashri Shankarraman→ | | Department of General Surgery,No. 1, Ramachandra Nagar, Porur, Chennai - 600116 → | debashri.shankar@hotmail.com→ | 9003286527→ | Sri Ramachandra Institute of Higher Education and Research, Chennai→ | Inclusion criteria: All those who presented with acute appendicitis between October 2020 to December 2020 as well as those with acute appendicitis between October 2019 to December 2019→ | Exclusion criteria: <br> All those above age of 18 years <br/ ><br> Any other acute abdominal pathology mimicking acute appendicitis<br> → |
Health Condition 1: K35- Acute appendicitis
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Control Intervention1: NIL: NIL<br>→ | To assess the impact of SARS CoV-2 virus on the clinical presentation, management, complications of acute appendicitisTimepoint: Assessment of parameters at baseline - on admission→ | | | | Yes | False | | |
| → | CTRI/2021/03/031666 | 23 March 2021 | Post-operative complications and mortality in patients with COVID 19 undergoing surgery under anaesthesia- A single centre retrospective case control study | Post-operative morbidity and mortality in patients with RT-PCR confirmed COVID19 undergoing surgery under regional or general anaesthesia- A single centre retrospective case control study. | | Dr Saloni Paranjape | 02-03-2021 | 20210302 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52917 | Not Recruiting | No | | | | 15-03-2021 | 30 | Observational |
Non-randomized, Multiple Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Dr Saloni Paranjape→ | | Dept Of Anaesthesia, second floor- OT complex, Pusa Road, Rajendra place, New Delhi Pusa Road, Rajendra place, New Delhi→ | drsaloni@gmail.com→ | 9958074656→ | BLK Superspeciality Hospital→ | Inclusion criteria: All COVID RTPCR positive patients undergoing surgery under general or regional anaesthesia→ | Exclusion criteria: <br> 1) Patients testing negative for COVID RTPCR prior to surgery <br/ ><br> 2) Patients testing positive for COVID RTPCR after surgery but were negative before surgery <br/ ><br> 3) Patients undergoing cardiac or neurosurgery<br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Control Intervention1: No intervention: Patients with COVID RTPCR positive undergoing emergency surgery will be compared with age and sex matched COVID RTPCR negative patients undergoing emergency surgery<br>→ | <br> To identify the outcomes of COVID 19 positive patients undergoing surgery in terms of post operative complications and mortalityTimepoint: 1) at discharge from hospital <br/ ><br> 2) 30 day mortality (from date of surgery)<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031662 | 23 March 2021 | Measure of Depression and Anxiety level in Home Isolated Covid positive patients | Evaluation of Depression and Anxiety in home quarantined Covid positive patients | | Smt NHL Municipal Medical College | 02-03-2021 | 20210302 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51935 | Not Recruiting | No | | | | 10-03-2021 | 200 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Dr Heena Jariwala→ | |
SVPIMSR, ELLISBRIDGE, AHMEDABAD, GUJARAT Department of Psychiatry,
NHLMMC
→ | itisnilima@gmail.com→ | 9328670900→ | SVPIMSR, Smt. NHL MMC→ | Inclusion criteria: <br> All consenting home quarantined COVID positive patients . <br/ ><br> → | Exclusion criteria: <br> Patients who are not willing to participate in the study. <br/ ><br> Patients already having Past H/O psychiatric illness. <br/ ><br> → |
Health Condition 1: A00-B99- Certain infectious and parasitic diseases
→ | | Level of Depression and Anxiety in home quarantined positive patientsTimepoint: Within 14 days of home quarantine period after patient is diagnosed as Covid positive→ | | | | Yes | False | | |
| → | CTRI/2021/03/031684 | 23 March 2021 | clinical study of Vardhamana Pippli Rasayana and WHO rehabilitation guidelines in the management of post Covid syndrome | Efficacy of Vardhamana Pippli Rasayana and WHO rehabilitation guidelines in the management of Post COVID 19 Syndrome - A Double arm Randomized Clinical Trial | | Institute of Teaching and Research in Ayurveda Institute of National Importance Ministry of Ayush | 03-03-2021 | 20210303 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52741 | Not Recruiting | No | | | | 10-03-2021 | 80 | Interventional |
Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
→<br> Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label<br> | Phase 3 | India→ | Dr Mandip Goyal→ | |
ITRA, OPD no 13, opp city B divison police station, PN marg, jamnagarITRA, jamnagar
ITRA, OPD no 13, opp city B divison police station, PN marg, jamnagar
→ | mandipgoyal22@gmail.com→ | 9427572306→ | ITRA, jamnagar→ | Inclusion criteria: Patients having lingering symptoms of COVID 19 after testing negative for the disease and extending beyond three weeks from the onset of a first symptom (Acute COVID 19).→ | Exclusion criteria: <br> 1. Positive SARS-CoV-2 PCR at the screening visit <br/ ><br> 2. Patients having severe symptoms of Post COVID 19 syndrome with co-morbidities requiring hospitalization <br/ ><br> 3. History of any of the following in the past 14 days: fever > 38.2 degrees Celsius; new or worsening respiratory symptoms (e.g. cough, dyspnea) <br/ ><br> 4. Patients having uncontrolled cardiac, renal, hepatic disease, malignancy, AIDS, diabetes <br/ ><br> 5. Pregnant and lactating women <br/ ><br> 6. Patients taking phenytoin, propranolol, theophylline (as Pippali has moderate interaction with the absorption of these drugs) <br/ ><br> 7. Patients having or progressive towards serious sequelae such as thromboembolic complications <br/ ><br> 8. COVID-19 patients whose acute illness required intensive care <br/ ><br> 9. SpO2 < 92 <br/ ><br> 10. Age below 18 years & above 60 years <br/ ><br> → |
Health Condition 1: A00-B99- Certain infectious and parasitic diseases
Health Condition 2: B342- Coronavirus infection, unspecified
Health Condition 3: O- Medical and Surgical
→ | <br> Intervention1: Vardhmana Pippali: In group A, Pippali powder will be given ingradually in increasing and tapering dose for 30 days with Mrudwika Sharkara<br><br> Control Intervention1: Rehabilitation programme by WHO: in group B, WHO rehabilitation guidelines in the management of Post COVID 19 Syndrome along with placebo capsule filled with rosted Suji powder 250 mg each BD after meal for 30days.<br>→ | It is expected that the trial drugs will have immunomodulatory effect and thus will effective in the management Post COVID 19 SyndromeTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/03/031687 | 23 March 2021 | Audit of Indian Clinical trials on COVID-19 | An audit of studies registered for COVID-19 infection with the Clinical Trials Registry of India - Indian COVID trials | | NIL | 03-03-2021 | 20210303 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53075 | Not Recruiting | No | | | | 30-03-2021 | 1000 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Vijaya Laxman Chaudhari→ | | 201 First Floor New MS building Seth GS Medical College and KEM Hospital, Acharya Donde Marg, Parel→ | vijugmc@yahoo.co.in→ | 02224133767→ | GSMC and KEM Hospital→ | Inclusion criteria: all studies registered under CTRI for COVID-19 infections in the year 2020 and 2021→ | Exclusion criteria: Studies not related to COVID-19→ |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | <br> 1. Total number of trials/studies registered for COVID-19 <br/ ><br> 2. Phase, (Phase Iâ??IV) <br/ ><br> 3. Nature (interventional or observational) <br/ ><br> 4. Source of funding (Pharmaceutical Industry/Government of India/Institute Funded) <br/ ><br> 5. Status of DCGI approval <br/ ><br> 6. Status of Ethics committee approval <br/ ><br> 7. National/International <br/ ><br> 8. Health type <br/ ><br> 9. Severity of the condition <br/ ><br> 10. Randomization type <br/ ><br> 11. Blinding <br/ ><br> 12. Primary and secondary end points <br/ ><br> 13. Sample size <br/ ><br> 14. Duration <br/ ><br> Timepoint: At the end of the study<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031685 | 23 March 2021 | â??COVID-19 vaccination: The dilemma faced by a Health care worker. | â??COVID-19 vaccination: The continuing dilemma of a health care workerâ?? | | Janakpuri Super Speciality Hospital Society | 03-03-2021 | 20210303 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53173 | Not Recruiting | No | | | | 05-03-2021 | 70 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Pragyan S Panda→ | |
Janakpuri Super Speciality Hospital Society.
Department of Microbiology
1st floor
C2B Janakpuri
New Delhi 110058 C2B Janakpuri
New Del→ | pragyanpanda2006@gmail.com→ | 9013072955→ | Janakpuri Super Speciality Hospital Society→ | Inclusion criteria: HCWs of Janakpuri Super Speciality Hospital Society, who has not undergone COVID-19 vaccination.→ | Exclusion criteria: None→ | | | <br> 1. Will be able to evaluate the reasons amongst HCWs for not availing their turn to undergo COVID-19 vaccination.Timepoint: Cross- sectional study <br/ ><br> for Qualitative evaluation of reasons amongst HCWs for not availing their turn undergo COVID-19 vaccination<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031686 | 23 March 2021 | Clinical Trial on Post Covid 19 through Ayurvedic intervention Agastya Haritaki amd Ashwagandha along with Yoga | A Randomized control trial to evaluate the efficacy of Ayurvedic interventions (Agastya Haritaki and Ashwagandha) and Yoga in long term effects of COVID-19 - POST COVID | | CCRAS Ministry Of AYUSH Govt of India | 03-03-2021 | 20210303 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53215 | Not Recruiting | No | | | | 10-03-2021 | 110 | Interventional |
Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
→<br> Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label<br> | Phase 3 | India→ | Govind Reddy→ | |
Regional Ayurveda Research Institute
NIT Complex, Gharkul Parisar, Near Vyankatesh Nagram, Nagpur Regional Ayurveda Research Institute
NIT Complex, Gharkul Parisar, Near Vyankatesh Nagram, Nagpu→ | drrgreddy68@gmail.com→ | 9820284671→ | Regional Ayurveda Research Institute→ | Inclusion criteria: <br> Patients with history of RT-PCR or IgM antibodies for SARS CoV-2 positivity before, not more than 4 weeks but having negative RT-PCR for SARS CoV-2 at the time of screening. <br/ ><br> Patients of either sex between 18 to 60 years <br/ ><br> Patients ambulatory and willing to provide informed written consent. <br/ ><br> → | Exclusion criteria: <br> Pregnant, Lactating women, patients with CKD (Chronic Kidney Disease). <br/ ><br> Not willing to participate in the study.<br> → |
Health Condition 1: -
→ | <br> Intervention1: A Randomized control trial to evaluate the efficacy of Ayurvedic interventions (Agastya Haritaki and Ashwagandha) and Yoga in long term effects of COVID-19-[POST COVID]: i.Agastya Haritaki<br> Dose: 6 g BD daily<br> Dosage form: Avaleha<br> Route of Administration : Oral<br> Time of Administration : Twice a day- after meals<br> Anupana : Warm water<br> Duration of therapy: 60 days<br> ii.AYUSH SR<br> (Ashwagandha Hydroalcoholic extract)<br> Dose: 500 mg BD daily<br> Dosage form: Tablet<br> Route of Administration : Oral<br> Time of Administration : Twice in a day- after meals<br> Anupana : Water<br> Duration of therapy: 60 days<br> iii.Yoga - As per National Clinical Management Protocol based on Ayurveda and Yoga for Management of COVID-19, Ministry of AYUSH<br> Control Intervention1: A Randomized control trial to evaluate the efficacy of Ayurvedic interventions (Agastya Haritaki and Ashwagandha) and Yoga in long term effects of COVID-19-[POST COVID]: WHO Rehabilitation Self-Management after COVID-19- Related Illness<br>→ | Change in respiratory function San Diego Shortness of Breath Questionnaire SOBQ 6min walk test and PFTTimepoint: One Month→ | | | | Yes | False | | |
| → | CTRI/2021/03/031721 | 23 March 2021 | Spironolactone on COVID-19 patients. | To evaluate the efficacy of combination of Dexamethasone and Spironolactone on the time to clinical recovery and freedom from supplemental oxygen dependence in COVID-19 patients. | | None | 04-03-2021 | 20210304 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53532 | Not Recruiting | No | | | | 16-03-2021 | 120 | Interventional |
Other
Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Other Blinding and masking:Participant and Investigator Blinded
→<br> Other<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Other Blinding and masking:Participant and Investigator Blinded<br> | N/A | India→ | Dr Bharti Wadhwa→ | |
Department Of Anesthesia
Maulana Azad Medical College
→ | drbhartitaneja@gmail.com→ | 9968604221→ | Maulana Azad Medical College→ | Inclusion criteria: <br> Confirmed COVID-19 by RT PCR test <br/ ><br> Hospitalized Non ventilated patients with oxygen by mask or nasal prongs (WHO <br/ ><br> Ordinal Scale 4: Appendix 1) <br/ ><br> SpO2 < 94% on room air but maintaining SpO2 of >94% on VenturiMask / Non <br/ ><br> rebreathing mask <br/ ><br> → | Exclusion criteria: <br> Participation in another clinical trial of an investigational medicinal product <br/ ><br> Known hypersensitivity to the IMP <br/ ><br> Significant electrolyte disturbance (Hyperkalemia: K+ >5.0 mmol/L) <br/ ><br> Patient currently receiving potassium sparing diuretics that cannot be reasonably <br/ ><br> withheld <br/ ><br> â?¢ Acute renal insufficiency <br/ ><br> â?¢ In the Investigatorâ??s opinion, patient is unwilling or unable to comply with drug <br/ ><br> administration plan, laboratory tests or other study procedures. <br/ ><br> â?¢ Pregnant or lactating patient <br/ ><br> â?¢ Patients on the following drugs : ACE inhibitors, Amiloride, Hydrocortisone, <br/ ><br> Prednisolone, Methylprednisolone, Triamterene<br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: Spironolactone: Spironolactone 50mg on day 1 followed by 25mg till day 21<br> Route Oral<br> Frequency OD<br><br> Control Intervention1: Dexamethasone and Standard of care.: Dexamethasone, Spironolactone and standard of care.<br> Control Intervention2: Dexamethasone: Dexamethasone and Standard of Care<br> Control Intervention3: Dexamethasone and Spironolactone: Dexamethasone, Spironolactone and Standard of care<br> Control Intervention4: Dexamethasone: Dexamethasone 6mg only for ten days<br> Route Oral<br> Frequency 3mg BD<br>→ | <br> 1.The time to recover, defined as the first day, during the 28 days after enrollment, on which a patient met the criteria for category 1,2, 0r 3 WHO ordinal scale. <br/ ><br> 2.To determine the effect of the medication on Von Willebrand Factor, Angiotensin II, aldosterone and D-Dimer Levels.Timepoint: Baseline <br/ ><br> Day 1 <br/ ><br> Day 4 <br/ ><br> Day 7<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031720 | 23 March 2021 | The study to explore the effect of Bacillus calusii and Bacillus Coagulans (the Probiotics) on Covid-19 disease progression in addition to routine Covid-19 treatment. | Safety and Efficacy of Bacillus clausii and Bacillus coagulans Spores as Add on to Standard Therapy to Study the Progress of SARS-CoV-2 Infection in Patients with Moderate Symptoms of COVID-19 - A Randomized, Double Blind, Placebo Control, Three Arm Parallel Group Study. | | Dr Mehdi Ali Mirza | 04-03-2021 | 20210304 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53161 | Not Recruiting | No | | | | 15-03-2021 | 90 | Interventional |
Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Participant and Investigator Blinded
→<br> Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Participant and Investigator Blinded<br> | N/A | India→ | Dr Mehdi Ali Mirza→ | |
Department of Pharmacology,
4th floor, Academic and Administration Block, Sanathnagar, Hyderabad.
→ | drrajivb85@gmail.com→ | 9885633040→ | ESIC Medical College and Hospital→ | Inclusion criteria: <br> 1. Patients of either gender, diagnosed to <br/ ><br> be COVID-19 positive through RTPCR <br/ ><br> method. <br/ ><br> 2. Patients presenting with moderate <br/ ><br> symptoms. <br/ ><br> 3. Patients of age more than 18 years. <br/ ><br> 4. Willing to comply with study related <br/ ><br> procedures. <br/ ><br> → | Exclusion criteria: <br> 1. Known history of hypersensitivity or <br/ ><br> allergy to probiotics <br/ ><br> 2. Pregnant or lactating woman <br/ ><br> 3. Patients with mild and severe infections, <br/ ><br> critically ill patients. <br/ ><br> 4. HIV or HBsAg positive <br/ ><br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: Bacillus clausii 2 billion Spores: orally administered, after food, morning and evening 2 times a day, for 14 days.<br> Intervention2: Bacillus coagulans 2 billion spores: orally administered, after food, 2 times a day, for 14 days.<br> Control Intervention1: Placebo: Orally administered, after food, 2 times a day, for 14 days.<br>→ | <br> 1. Time to Clinical <br/ ><br> recovery after <br/ ><br> hospitalization <br/ ><br> 2. Improvement in <br/ ><br> inflammatory, immune <br/ ><br> and clinical <br/ ><br> parameters <br/ ><br> 3. Proportion of <br/ ><br> patients recovering <br/ ><br> in each group <br/ ><br> Timepoint: Clinical parameter- day1 to day 14 <br/ ><br> laboratory parameters- day 1,3,7,14 respectively.<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031756 | 23 March 2021 | A study to investigate the performance of the rapid antigen test kit for detecting the SARs-CoV2 coronavirus. |
AN OPEN LABEL, SINGLE CENTRE STUDY TO EVALUATE THE PERFOMANCE OF THE
RAPID ANTIGEN TEST KIT USING NASO-PHARYNGEAL / OROPHARYNGEAL SWAB IN
COVID-19 (SARS-CoV2)
| | Cipla Ltd | 08-03-2021 | 20210308 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53298 | Not Recruiting | No | | | | 08-03-2021 | 100 | Observational |
Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
→<br> Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label<br> | N/A | India→ | Mr Abhijit Vaidya→ | | 289 Bellasis Road Mumbai Central → | Sandesh.Sawant3@Cipla.com→ | 02223025188→ | Cipla Ltd→ | Inclusion criteria: <br> 1. A voluntarily given data sharing consent from subjects and/or from legally acceptable representative (in case subject is not <br/ ><br> conscious and oriented). <br/ ><br> 2. Subjects of 18 years and above with suspected COVID 19 symptoms. <br/ ><br> 3. No previous or experimental treatment for pneumonia associated with a novel coronavirus infection.<br> → | Exclusion criteria: <br> 1. Subjects with history of diseases that need to be distinguished from new coronavirus infection pneumonia, such as tuberculosis, bacterial or viral pneumonia other than new coronavirus pneumonia, hospital-acquired pneumonia, and other pathogenic pneumonia. <br/ ><br> 2. Subjects with blood in their sputum or saliva. <br/ ><br> 3. The investigator determines that the subject is not appropriate to participate in the clinical study.<br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: Nil: Not applicable as the study is for validation of diagnostic kit performance<br> Control Intervention1: NIL: Not applicable as the study is for validation of diagnostic kit performance<br>→ | Sensitivity and specificity of rapid antigen detection kitTimepoint: Once→ | | | | Yes | False | | |
| → | CTRI/2021/03/031790 | 23 March 2021 | Ketoji a nutritional therapy in management of symptoms of Covid-19 patients. | An Investigator initiated single blind, single centre, proof of concept study of Ketoji (liquid) for its effectiveness in the management of covid-19 patients. | | Department of Pharmaceutical Sciences Guru Nanak Dev University Amritsar | 08-03-2021 | 20210308 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53090 | Not Recruiting | No | | | | 15-03-2021 | 60 | Interventional |
Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Participant Blinded
→<br> Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Participant Blinded<br> | Phase 2 | India→ | Navid Reza Shahtaghi→ | | Department of Pharmaceutical Sciences, Guru Nanak Dev University, Amritsar. → | subheetjain.pharma@gndu.ac.in→ | | Guru Nanak Dev University, Amritsar.→ | Inclusion criteria: <br> a. Patients of either sex, 18 to 75 years of age (both inclusive). <br/ ><br> b. Patients with diagnosis of coronavirus (SARS-CoV-2) infection conformed by polymerase chain reaction (PCR) test and sign of mild acute respiratory infection or with respiratory stress. <br/ ><br> c. Patients with body muscle pain/fatigue. <br/ ><br> d. Able to abide the dietary regime mentioned by the investigator. <br/ ><br> e. Willing to come for regular follow â??up visits. <br/ ><br> f. Able to give written informed consent. <br/ ><br> → | Exclusion criteria: <br> a. Known history of hypersensitivity to dietary supplements. <br/ ><br> b. Volunteers receiving any COVID-19 specific antiviral treatment. <br/ ><br> c. Concurrent respiratory diseases such as COPD (chronic obstructive pulmonary disease), IPF and/or intermittent, persistent or more severe asthma requiring daily therapy or any subjects that have had an asthma flare requiring corticosteroids in the 4 weeks (28 days) prior to COVID-19 diagnosis. <br/ ><br> d. Malignancy within the past 3 years with the exception of in situ removal of basal cell carcinoma and cervical intraepithelial neoplasia grade I. <br/ ><br> e. Volunteers having systemic diseases like diabetes mellitus (Type I or Type II) and other debilitating metabolic diseases. <br/ ><br> f. Pregnant or lactating women <br/ ><br> g. Female subjects of childbearing potential not willing to use contraceptive methods <br/ ><br> h. Male subjects not willing to use contraceptive methods <br/ ><br> i. On-going treatment with herbals or any other immune boosting dietary supplements. <br/ ><br> j. History of having received any investigational drug or participated in any other clinical trial which ended in the preceding three months or currently ongoing. <br/ ><br> k. Patients with ARDS of Cardiac origin <br/ ><br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J988- Other specified respiratory disorders
→ | <br> Intervention1: Ketoji: Ketoji is the most â??potentâ?? exogenous or oral source of therapeutic ketone supplement as Ketone ester (D-Ã?hydroxybutyrate ester)<br> Dosing will be done on day 0, 3, and 5<br> Control Intervention1: Normal Routine Therapy for Covid-19 Patients: Comparison will be done against the group receiving normal routine therapy that is already being used in management of Covid-19 patients. Daily therapy<br>→ | <br> a. Body Temperature. <br/ ><br> b. pO2, pCO2 (blood gas analysis, daily until the patient is wean off the ventilator). <br/ ><br> c. Showing improvement P/ F ratio <br/ ><br> d. Subjectâ??s feedback on muscle fatigue and overall well-being, atleast 5 days from last visit (post COVID-19). <br/ ><br> e. Chest X Ray or CT shows improved pulmonary edema or bilateral, patchy alveolar opacities/ consolidations â??â??white lungâ??â?? appearance. <br/ ><br> Timepoint: 0, 3 and 5 day<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031774 | 23 March 2021 | â??Clinical profile and outcomes of COVID-19 patients admitted to an intensive care unit in a tertiary care hospitalâ??. | â??Clinical profile and outcomes of COVID-19 patients admitted to an intensive care unit in a tertiary care hospitalâ??. | | Sri Ramachandra University | 08-03-2021 | 20210308 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53613 | Not Recruiting | No | | | | 15-03-2021 | 250 | Observational |
Other
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Investigator Blinded
→<br> Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Investigator Blinded<br> | N/A | India→ | RENUKA M K→ | |
Critical Care Medicine Dept , Sri Ramachandra Hospital,
Ist floor link Room no 123,Sri Ramachandra University , Porur, Chennai
→ | renuramanujam@gmail.com→ | 8056126336→ | Sri Ramachandra University→ | Inclusion criteria: Patients who are admitted with COVID positive status and requiring intensive monitoring and intervention→ | Exclusion criteria: age below 17 yrs and non COVID status→ |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | | mortalityTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/03/031757 | 23 March 2021 | COVID 19 Infected ST-Elevation Myocardial Infarction in INDIA (COSTA INDIA) - A Cardiological Society of India Study |
COVID 19 Infected ST-Elevation Myocardial lnfarction in INDIA (COSTA INDIA)
| | Cardiological Society of India | 08-03-2021 | 20210308 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53151 | Not Recruiting | No | | | | 10-03-2021 | 1000 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Dr Jabir Abdullakutty→ | | Lisie Heart Institute, Lisie Hospital, Kacheripady PO, Ernakulam → | costaindia2020@gmail.com→ | 9447011773→ | Director of Academic Affairs and Clinical Research→ | Inclusion criteria: All consecutive patients above the age of 18 years with STEMI or with new LBBB on 12 lead ECG and diagnosed as acute myocardial infarction (MI) as per the fourth universal definition of MI and COVID-19 positive. The cases could be STEMI patients shown to be COVID-19 positive during routine screening after admission or referred from elsewhere as COVID positive or STEMI developing in the hospital after admission for treatment of COVID 19 infection. COVID-19 infection should be confirmed with RTPCR / Truenat / CBnat / rapid antigen test. Age and sex-matched STEMI patients who are COVID negative will be enrolled as the control group for comparison in a 2:1 ratio.→ | Exclusion criteria: <br> patients below the age of 18 years <br/ ><br> Patients with STEMI who are COVID-19 negative <br/ ><br> → |
Health Condition 1: I229- Subsequent ST elevation (STEMI) myocardial infarction of unspecified site
→ | <br> Intervention1: NIL: NIL<br>→ | <br> 1.To find out differences in the composite of in-hospital mortality, heart failure, shock, stroke and systemic embolizations in COVID-19 infected STEMI patients compared to age and sex-matched non-infected STEMI patients treated during the same period. <br/ ><br> 2. To find out changes in the management strategies of COVID-infected STEMI patients compared to non-infected age and sex-matched STEMI controls treated during the same period. <br/ ><br> Timepoint: This nationwide retrospective observational study on the clinical presentation, clinical course, and in-hospital outcomes of COVID-infected STEMI patients admitted during the period May 1st, 2020 to December 31 st, 2020.<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031813 | 23 March 2021 | Concerns and trust that form the basis for general public living in an Indian city, to accept or not to accept COVID-19 vaccine - a qualitative study | Ethics and dilemma regarding acceptance of COVID-19 vaccine among people living in Mumbai, a metropolitan city in India â?? a qualitative study | | Seth GS Medical College KEM Hospital | 09-03-2021 | 20210309 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51555 | Recruiting | No | | | | 10-03-2021 | 15 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Dr Jeffrey Pradeep Raj→ | |
Dept. of Clinical Pharmacology,
Seth GS Medical College, Acharye Donde Marg, Parel, Mumbai.
→ | jpraj.m07@gmail.com→ | 7904286189→ | Seth GS Medical College & KEM Hospital→ | Inclusion criteria: <br> Adult participants (18 years and above) of any gender <br/ ><br> Willing to provide written informed consent <br/ ><br> Able to speak in English <br/ ><br> → | Exclusion criteria: <br> Health care workers / Those involved in clinical research <br/ ><br> Those who have participated in clinical trials of COVID-19 vaccine <br/ ><br> → | | <br> Intervention1: In-depth interview: An in-depth interview will be conducted to understand the concerns and dilemmas that would translate into someone accepting or not accepting the COVID-19 vaccine<br> Control Intervention1: Not applicable: Not applicable<br>→ | Perceived ethical aspects and dilemma that factor in with regards to the acceptance of COVID-19 vaccineTimepoint: At Baseline→ | | | | Yes | False | | |
| → | CTRI/2021/03/031841 | 23 March 2021 | Non-contact kiosk for screening COVID19 | Validation of non-contact health screening kiosk for COVID19 patients visiting Kasturba hospital, Manipal | | Manipal Academy of Higher Education Manipal | 09-03-2021 | 20210309 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51148 | Not Recruiting | No | | | | 20-03-2021 | 6800 | Observational |
Single Arm Trial
Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable
→<br> Single Arm Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable<br> | N/A | India→ | Dr Muralidhar Varma→ | |
Department of Infectious Diseases
KMC Manipal
Manipal
→ | muralidhar.varma@manipal.edu→ | | KMC Manipal, MAHE→ | Inclusion criteria: <br> 1) All the clients (patients and patient caretakers) of Kasturba Hospital who are waiting for their <br/ ><br> entry into the hospital premises. <br/ ><br> 2) Both the genders of the age group between 5 years to 80 years who can sit in the wheel chair and <br/ ><br> can walk independently and the care takers of the primary patient.<br> → | Exclusion criteria: <br> 1) Patients visiting the emergency triage <br/ ><br> 2) Unconscious, mentally challenged, non-comprehending patients and patients who are confined <br/ ><br> to stretchers. <br/ ><br> 3) Pregnancy , infants and children of age below 5 years<br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Control Intervention1: NIL: NIL<br>→ | <br> 1) The proposed non-contact health screening kiosk technology will be able to effectively identify <br/ ><br> COVID19 patients with more accuracy compared to simple IR thermometer, which merely <br/ ><br> measures the skin shell temperature.Timepoint: its only a single time point study<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031815 | 23 March 2021 | An Anti-Viral Ayurvedic formulation for the treatment of COVID-19 Patients | A clinical study to evaluate the effect of livance-c, an anti-viral ayurvedic formulation for the treatment of covid-19 patients | | Avance Phytotherapies Pvt Ltd | 09-03-2021 | 20210309 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52987 | Not Recruiting | No | | | | 15-03-2021 | 100 | Interventional |
Randomized, Parallel Group Trial
Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label
→<br> Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label<br> | Phase 3 | India→ | Dr R G Viveki→ | | Dept. Institutional Ethics Committee Belgaum Institute of Medical sciences, Belgaum 590 010,India → | drgiridharay@gmail.com→ | 919731028625→ | Shri B. M. Kankanawadi Ayurved Mahavidyalaya→ | Inclusion criteria: <br> Freshly detected and confirmed positive (by means of RT-PCR) COVID-19 patients requiring admission. <br/ ><br> Patients on whom no other (specifically targeted to treat COVID-19) treatment has been initiated. (Patients on supportive care can be considered for inclusion). <br/ ><br> Patients who have consented (written informed consent) to be treated <br/ ><br> with the trial drug as the primary treatment. <br/ ><br> Patient is in the age group between 18-65years. <br/ ><br> Patient has persistent fever â?¥99.50 F and is currently maintained on <br/ ><br> antipyretics. <br/ ><br> Patient is unable to take a deep breath and/ or not able to hold for â?¥ 20 <br/ ><br> seconds. <br/ ><br> Patient has a history of cough since â?¥ 3 days. <br/ ><br> Patient has a history of body aches or tiredness or unusual fatigue lately <br/ ><br> (â?¥ 7 days). <br/ ><br> Patients ability in the investigators opinion to comply with the protocol <br/ ><br> procedures.<br> → | Exclusion criteria: <br> â?¢Suspected patients with COVID19, but not confirmed by RT-PCR test. <br/ ><br> â?¢Confirmed positive Patient on whom already alternative medical treatment has been initiated. <br/ ><br> â?¢History of tuberculosis. <br/ ><br> â?¢History / evidence of allergy or hypersensitivity to Hydroxychloroquine sulfate or of herbal drugs or to any of the inactive ingredients of the formulation or to any other drug. <br/ ><br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: Livance C Capsule: Livance C 400mg Capsule Twice daily for 15 days<br> Control Intervention1: Mono-Therapy: hydroxycholroquine 400 mg Twice a daily for 10 days<br>→ | Assessment of the time taken from initiation of the study treatment to the day of discharge. Discharge criteria is defined as a negative RT-PCR test for respiratory tract samples (nasopharynx and throat swabs) and re-confirmed after at least 24 hoursTimepoint: Day -01→ | | | | Yes | False | | |
| → | CTRI/2021/03/031898 | 23 March 2021 | Willingness to Accept COVID 19 vaccine In India: A Web Based Survey | Potential Acceptance of COVID 19 Vaccine in India: A Web Based Survey | | NA | 10-03-2021 | 20210310 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53719 | Not Recruiting | No | | | | 21-03-2021 | 1000 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Amal Ameer→ | | Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences, MAHE → | rajesh.r@manipal.edu→ | 9448374166→ | Manipal Academy of Higher Education→ | Inclusion criteria: Open to all Indian Population→ | Exclusion criteria: Anyone not willing to participate due to any reason→ | | <br> Intervention1: NIL: NIL<br> Control Intervention1: NIL: NIL<br>→ | <br> To know how many people are willing to take COVID 19 vaccine <br/ ><br> <br/ ><br> To know if the occupation is one of the reason to take vaccine <br/ ><br> <br/ ><br> To know which brand do people prefer <br/ ><br> <br/ ><br> To know if the cost is one of the reason of people taking or not taking the vaccineTimepoint: 24 weeks<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031933 | 23 March 2021 | SARS CoV 2 antibody status of health care workers in a covid tertiary care hospital in Bangalore, Karnataka. | SARS CoV 2- specific Serological status of health care workers in a covid tertiary care hospital in Bangalore, Karnataka. | | Rajarajeswari medical college and hospital | 11-03-2021 | 20210311 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53812 | Not Recruiting | No | | | | 19-03-2021 | 250 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Sadaf Idris→ | |
Department of biochemistry
Room no A103
202 Kambipura Mysore road, Bengaluru, 560074
→ | isshaidris@gmail.com→ | 9916772063→ | RajaRajeswari Medical College & Hospital→ | Inclusion criteria: employees of RRMCH (list obtained from the human resource department) who were posted for covid duty (direct patient contact)→ | Exclusion criteria: who had active symptoms of Covid 19 and history of a positive rtPCR of less than 14days history at the time of testing.→ | | | Seroprevalence Data of SARS CoV 2 antibody status of health care workers in a tertiary care hospitalTimepoint: Baseline, before vaccination→ | | | | Yes | False | | |
| → | CTRI/2021/03/031907 | 23 March 2021 | Assessment of physical activity and perception about health among adults during COVID-19 pandemic in India | A study to assess the physical activity and perceived health status among adults during COVID-19 pandemic in India | | Jevita D Souza | 11-03-2021 | 20210311 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50741 | Not Recruiting | No | | | | 13-03-2021 | 800 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Jevita D Souza→ | |
Room No 402
Department of Medical Surgical Nursing
Manipal College of Nursing, Manipal Manipal Academy of Higher Education Manipal Room No 402
Department of Medical Surgical → | latha.tbhat@manipal.edu→ | 9886398574→ | Manipal College of Nursing Manipal→ | Inclusion criteria: <br> Adults above 18 years <br/ ><br> Adults who use internet based modes of communication <br/ ><br> Adults living in COVID-19 pandemic rural, semi-urban and urban areas of India<br> → | Exclusion criteria: → | | <br> Intervention1: Nil: Nil<br>→ | Assessing the physical activity and perceived health status among adultsTimepoint: 10-12-2020 to 17-11-2021→ | | | | Yes | False | | |
| → | CTRI/2021/03/031945 | 23 March 2021 | This is a study to describe the various poisonings and injuries that occurred during the COVID-19 pandemic lockdown in Bangalore, India | A DESCRIPTIVE STUDY OF INJURIES AND DRUG OVERDOSAGE/POISONING DURING LOCKDOWN PERIOD FOR COVID -19 PANDEMIC AT AN URBAN TERTIARY CARE HOSPITAL IN INDIA | | DEPARTMENT OF EMERGENCY MEDICINE ST JOHNS MEDICAL COLLEGE AND HOSPITAL | 12-03-2021 | 20210312 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53809 | Recruiting | No | | | | 01-04-2021 | 650 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | MANASA S SESHADRI→ | |
DEPARTMENT OF EMERGENCY MEDICINE
ST.JOHNS MEDICAL COLLEGE AND HOSPITAL
BANGALORE ST. JOHNS MEDICAL COLLEGE AND HOSPITAL
SARJAPUR ROAD
BANGALORE - 560034
→ | drmanasa.seshadri@gmail.com→ | 9886898951→ | ST. JOHNS MEDICAL COLLEGE AND HOSPITAL→ | Inclusion criteria: ALL INJURIES (INTENTIONAL AND UNINTENTIONAL) AND DRUG OVERDOSE / POISOINING DURING THE LOCKDOWN PERIOD (MARCH 25 2020 - JUNE 8 2020)→ | Exclusion criteria: <br> PATIENTS WITH AGE BELOW 18 YEARS <br/ ><br> PATIENTS WITH BITES AND STINGS<br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: S00-T88- Injury, poisoning and certain other consequences of external causes
→ | | Injury or PoisoningTimepoint: At admission or 30 days→ | | | | Yes | False | | |
| → | CTRI/2021/03/031939 | 23 March 2021 | Immediate effect of positioning on oxygen level in patients with COVID 19. | Immediate effect of prone and side lying position on oxygen saturation in patients with COVID 19- A Randomised Controlled Trial | | MGM Medical Hospital Aurangabad | 12-03-2021 | 20210312 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49214 | Not Recruiting | No | | | | 15-03-2021 | 45 | Interventional |
Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Alternation Blinding and masking:Participant Blinded
→<br> Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Alternation Blinding and masking:Participant Blinded<br> | N/A | India→ | Payal vasant dhawale→ | | N-11, plot no -1 HUDCO , Aurangabad MGM Institute of Physiotherapy,N-6 , CIDCO, Aurangabad→ | payaldhawale62@gmail.com→ | 7276155645→ | MGM Institute of Physiotherapy→ | Inclusion criteria: <br> Both male& female patients with covid 19. <br/ ><br> Patients who are willing to participate in the study. <br/ ><br> Patients with definite diagnosis of COVID-19 <br/ ><br> Patients who required additional oxygen supplementation (HFNC) <br/ ><br> Age group of >30 years both male and female<br> → | Exclusion criteria: <br> Patients on mechanical ventilator <br/ ><br> COPD or any other respiratory disease <br/ ><br> Moderate or severe heart disease (grade 3 or 4, New York Heart Association) <br/ ><br> Severe ischemic or hemorrhagic stroke or any neurodegenerative disease. <br/ ><br> Unwillingness to participate in the study<br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: Prone position after doing Diaphragmatic breathing exercises, thoracic expansion exercise<br><br> Lateral Position after doing Diaphragmatic breathing exercises, thoracic expansion exercise: All the groups will receive breathing exercises (Diaphragmatic breathing exercises, thoracic expansion exercises) and patients will adopt the position (supine) after breathing exercises for 1 hour. oxygen saturation were charted at 0, 30 and 60 min from the start of session.<br> Frequency - 1 session per day<br> The patientâ??s face could be placed on either side and patients were allowed to adjust their position for comfort.<br> Control Intervention1: Supine Position after doing Diaphragmatic breathing exercises, thoracic expansion exercise: All the groups will receive breathing exercises (Diaphragmatic breathing exercises, thoracic expansion exercises) and patients will adopt the position (supine) after breathing exercises for 1 hour.<br> Frequency - 1 session per day<br>→ | Spo2Timepoint: 1 hour→ | | | | Yes | False | | |
| → | CTRI/2021/03/031940 | 23 March 2021 | Clinical trial for TADIOS as supplemental therapy in mild to moderate COVID-19 | Multicenter, double-blind, placebo-controlled, maximum 10 days administration study to evaluate the efficacy and safety of TADIOS as an adjuvant therapy in patients diagnosed with mild to moderate COVID-19 | | Helixmith Co Ltd | 12-03-2021 | 20210312 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53172 | Not Recruiting | No | | | | 16-03-2021 | 100 | Interventional |
Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant and Investigator Blinded
→<br> Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant and Investigator Blinded<br> | N/A | India→ | Deepak Gowda→ | | Building # 06, 3rd floor, 2nd Main Rd, opposite to British Biologicals, Sarvobhogam Nagar, Arekere → | deepak.gowda@syncorphealth.com→ | 9972434444→ | Syncorp Health Private Limited→ | Inclusion criteria: <br> 1. Male or Female, aged between 18 to 65 years (both inclusive) <br/ ><br> 2. Confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) first infection by a reverse transcription polymerase chain reaction (RT-PCR) assay in nasal swab or oropharyngeal swab samples. <br/ ><br> 3. Patients who are hospitalized into designated hospital for COVID 19 treatment <br/ ><br> 4. Patients who can be treated within 24 hours after confirmed diagnosis with COVID-19 <br/ ><br> 5. Patients with mild COVID-19 or moderate COVID-19 according to clinical management guideline of Government of India. <br/ ><br> a) Mild Illness: Patients with uncomplicated upper respiratory tract viral infection, may have non-specific symptoms such as fever, cough, sore throat, nasal congestion, malaise, and headache. The elderly may present with atypical symptoms. These patients do not have any signs of dehydration, sepsis or shortness of breath. <br/ ><br> b) Moderate Illness: Patient with pneumonia and no signs of severe pneumonia (Chest X-ray will be performed to rule out pneumonia in the suspected subjects). <br/ ><br> 6. Patients who have signed the written informed consent form approved by Ethics Committee to participate after understanding explanations regarding the study <br/ ><br> 7. Those who can comply with the requirements and processes in the clinical study <br/ ><br> 8. Women of childbearing age must be negative to urine pregnancy test during screening <br/ ><br> → | Exclusion criteria: <br> 1. Patients with severe COVID-19 <br/ ><br> 2. Self-reported history of meaningful circulatory, renal, gastrointestinal, liver, endocrinal, hematological, or mental disease, or other serious diseases or alcohol or drug addiction that may cause safety issues or confusion in the interpretation of clinical research results by the principal investigatorâ??s judgment <br/ ><br> 3. Female patients who are pregnant (confirmed through urine pregnancy test) or breastfeeding <br/ ><br> 4. Patients with disease as follows: <br/ ><br> I. Cardiovascular disease <br/ ><br> a) Troponin I â?¥1.5 times of upper normal limit (UNL) <br/ ><br> II. Chronic liver disease with <br/ ><br> a) total bilirubin â?¥2 x UNL <br/ ><br> b) Aspartate transaminase (AST) and alanine transaminase (ALT) â?¥3 times of UNL <br/ ><br> III. Self-reported patients Cancer <br/ ><br> IV. Chronic kidney disease with <br/ ><br> a) Serum creatinine â?¥2 mg/dL or <br/ ><br> b) Dialysis due to chronic renal failure <br/ ><br> 5. Self-reported patients being a recipient of immunosuppressive therapy <br/ ><br> 6. Self-reported patients who are allergic to this dietary supplements <br/ ><br> 7. Patients taking a health functional food or medicine that may affect the bodyâ??s antioxidant, anti-inflammatory activity, and lungs within 6 weeks of the first visit <br/ ><br> a) Chlorella, spirulina, green tea extract, propolis, coenzyme Q10, squalene, zinc, selenium, ginseng, L-carnitine, omega-3, fatty acids/fish oil, carotenoids, lycopene, lutein, zeaxanthin, polyphenols, flavonoids, pycnogenol, silymarin, and L-arginine <br/ ><br> b) Bronchodilators (β2 adrenergic agonists, theophylline, anticholinergic drugs or parasympatholytic drugs, etc), antitussive/expectorant drugs, adrenal cortical hormone drugs, antibiotics, immunosuppressants, vasodilators (nitroglycerin, etc), N-acetylcysteine, betaine, L-acetyl carnitine, lipoic acid, glutathione, inositol, myo-inositol (inositol), thioredoxin, glutaredoxin, melatonin, pentoxifylline, and S-adenosyl-methionine <br/ ><br> 8. Patients who participated in another clinical trial within 1 month before screening <br/ ><br> 9. Patients have any condition that in the judgement of investigator make the subject inappropriate for entry into this study <br/ ><br> 10. Patients consuming any herbal medicine <br/ ><br> 11. Self-reported patients with cases of surgical menopause (hysterectomy, oophorectomy of both ovaries) or sterilization procedures (tubal ligation or tubectomy of both fallopian tubes). Menopause refers to 1 year of no menstruation. <br/ ><br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: Tadios along with standard of care treatment: Test Product: TADIOS<br> Dose: 2400 mg/day (4 tablets of 300 mg active ingredient twice a day) for maximum 10 days along with standard of care treatment.<br> Route of administration: Orally with water<br><br> Control Intervention1: Standard of care treatment plus placebo: Placebo Dose: 2400 mg/day (4 tablets of 300 mg placebo twice a day) for maximum 10 days along with standard of care treatment.<br> Route of administration: Orally with water<br><br>→ | <br> (1) Antioxidative and inflammatory biomarkers: TNF-α, CRP, IL-6, IL-1ra, Hb, and Ferritin <br/ ><br> (2) Clinical measurements- <br/ ><br> a) 8-point ordinal scale for clinical improvement <br/ ><br> b) Time to clinical recovery in clinical symptom scale <br/ ><br> c) Proportion of clinical improvement in clinical in symptom scale <br/ ><br> (3) Quality of life <br/ ><br> a) WHOQOL-WHO 5 wellbeing scale <br/ ><br> b) Fatigueness assessment through fatigue severity scale <br/ ><br> (4) Hospitalization <br/ ><br> a) Duration of hospitalization <br/ ><br> b) Time to discharge <br/ ><br> Timepoint: Day 0, Day 10 or discharge or early termination, and Day 14. <br/ ><br> clinical symptom scale daily till discharge<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031998 | 23 March 2021 | To determine the safety and antibody performance in Indian adults after taking COVID-19 vaccine. | Safety and antibody kinetics of the ChAdOx1 nCoV-19 vaccine in Indian adults. - COVID Study | | Advanced Cancer for Treatment Research and Education in cancer and Tata Memorial Centre | 15-03-2021 | 20210315 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53828 | Not Recruiting | No | | | | 21-03-2021 | 6000 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Dr Vikram Gota→ | | Department of Clinical Pharmacology, Advanced Centre for Treatment, Research and Education in Cancer (ACTREC), Tata Memorial Centre, Sector 22, Kharghar, Navi Mumbai → | vikramgota@gmail.com→ | 02227405493→ | Advanced Centre for Treatment, Research and Education in Cancer (ACTREC)→ | Inclusion criteria: <br> 1) Adults â?¥ 18 years. <br/ ><br> 2) TMC staff who received at least one dose of the ChAdOx1 nCoV-19 vaccine at the KEM vaccination centre. <br/ ><br> 3) All individuals who got vaccinated at ACTREC vaccination centre.<br> → | Exclusion criteria: <br> None. <br/ ><br> Anyone fulfilling the inclusion criteria will be eligible for the study<br> → | | <br> Intervention1: None: Not Applicable<br> Intervention2: NIL: NIL<br> Control Intervention1: NIL: NIL<br>→ | <br> To evaluate safety for the vaccine in participants receiving at least 1 dose of the vaccine.Timepoint: 1) Local reactions for up to 7 days following each dose. <br/ ><br> <br/ ><br> 2)Systemic events for up to 7 days following each dose. <br/ ><br> <br/ ><br> 3) Adverse events (AEs) from Dose 1 to 1 month after the last dose. <br/ ><br> <br/ ><br> 4) Serious AEs (SAEs) from Dose 1 to 6 months after the last dose.<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031969 | 23 March 2021 | Reducing systemic inflammation in cancer patients with COVID-19 using Topotecan with Dexamethasone and Remdesivir | Phase I-II study of Topotecan combined with Dexamethasone and Remdesivir to reduce systemic inflammation in cancer patients with COVID-19 - TopVid1 | | National University Cancer Institute of Singapore NCIS National University Hospital Singapore | 15-03-2021 | 20210315 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52816 | Not Recruiting | No | | | | 15-03-2021 | 18 | Interventional |
Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | Phase 1/ Phase 2 | India→ | Dr Ajoy Oommen John→ | |
Department of Medical Oncology,
Christian Medical College,
Ida Scudder Road, Vellore- 632004, Tamil Nadu, India
→ | ajoyoommenjohn@gmail.com→ | | Christian Medical College, Vellore→ | Inclusion criteria: <br> 1) with current or past history of cancer <br/ ><br> 2) SARS-CoV-2 infection confirmed by at least 1 positive PCR test <br/ ><br> 3) Admission to hospital for monitoring and/or supportive care <br/ ><br> 4) Absolute neutrophil count (ANC) â?¥ 1.5 x 109/L. Platelets â?¥ 75 x 109/L, Haemoglobin â?¥ 9x 109/L. <br/ ><br> 5) Bilirubin < 1.5 times upper limit of normal (ULN). ALT and AST < 2.5 times ULN. <br/ ><br> 6) Calculated creatinine clearance of â?¥ 30ml/min calculated using the formula of Cockcroft and Gault: (140-age) x mass (kg)/)72x creatinine mg/dl); multiple by 0.85 if female. <br/ ><br> 7) Able to comply with study related procedures and able to provide informed consent <br/ ><br> → | Exclusion criteria: <br> 1) Severe COVID; as defined by the requirement for ICU care. <br/ ><br> 2) Any immunosuppressive medication (excluding steroids) administered concurrently or within last 15 days. <br/ ><br> 3) Pregnancy or Breastfeeding. <br/ ><br> 4) Known allergy to Topotecan. Unconjugated hyperbilirubinemia on a fasting LFT, which can indicate Gilberts Syndrome. <br/ ><br> 5) Suspected active bacterial, fungal, or other infection in addition to COVID-19. <br/ ><br> 6) Any condition that would, in the opinion of the Investigator, increase the risk of the participant by participating in the study. <br/ ><br> 7) Inability to provide consent or unable to comply with study procedures <br/ ><br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | <br> Intervention1: Topotecan<br> Dexamethasone<br> Remdesivir: Tab. Topotecan 0.25mg single dose on D2 of admission given orally.<br> Tab. Dexamethasone 6mg OD D1-10 of admission, given orally.<br> Tab. Remdesivir 100mg/day D1-5 of admission, given orally.<br> If primary outcome of elevated serum Topotecan levels and neutropenia is not achieved after 3 patients, another 3 patients will be recruited at the same dose level. If outcome is not achieved, then the dose of topotecan will be escalated to 0.5mg and the protocol repeated for another 6 patients. If still unachieved, then the final dose escalation to Topotecan 0.75mg will be done. Maximum of 18 patients will be recruited to the study.<br> Control Intervention1: Dexamethasone<br> Remdesivir: Tab. Dexamethasone 6mg OD D1-10 of admission, given orally.<br> Tab. Remdesivir 100mg/day D1-5 of admission, given orally.<br>→ | <br> 1. Topotecan AUC of less than 15000nM-min (or CMax of 100nM) 2. neutropeniaTimepoint: 1. Topotecan levels at pre-treatment 1 hour and 24 hours. <br/ ><br> 2.blood counts - 2x/ week (D3, D7, D10 and D14) <br/ ><br> → | | | | Yes | False | | |
| → | CTRI/2021/03/031970 | 23 March 2021 | LDH and Ferritin levels in Diabetes Mellitus. | A Comparative Study of Inflammatory Markers among Covid Positive Controlled & Uncontrolled Diabetic Patients Retrospective Study. | | Self | 15-03-2021 | 20210315 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52372 | Not Recruiting | No | | | | 29-03-2021 | 100 | Observational |
Other
Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:
→<br> Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:<br> | N/A | India→ | Dr Sumantara N S→ | |
RajaRajeswari Medical College and Hospital
Department of Biochemistry
Bangalore Mysore linking Road
Kambipura Gate
560074
→ | sumantara90@gmail.com→ | 8553653468→ | Rajarajeswari medical college and hospital→ | Inclusion criteria: Confirmed Covid-19 Positive patients diagnosed by RT PCR with pre-existing Diabetes mellitus.→ | Exclusion criteria: Patients with history of other co-morbidities like renal diseases, Liver diseases, Hypertension, malignancy, Heart diseases, Arthritis→ |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: E086- Diabetes mellitus due to underlying condition with other specified complications
→ | | Higher serum LDH, ferritin and lower albumin levels are the crucial factors in diabetes mellitus to assess the severity of COVID 19 infection and as inflammatory markers especially in uncontrolled diabetic patients.Timepoint: Six months→ | | | | Yes | False | | |
| → | CTRI/2021/03/032037 | 23 March 2021 | An Online Survey of Knowledge, Attitude and Perception of COVID-19 Vaccine in Non-vaccinated Individuals from the age group of 18-25 years of age. | Knowledge, Attitude and Perception of COVID-19 Vaccine Among Non-vaccinated Young Adults- An Online Survey. | | Researcher Self Funded | 16-03-2021 | 20210316 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53771 | Not Recruiting | No | | | | 22-03-2021 | 500 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Mr Kaustubh J Augustine→ | |
Physiotherapy School and Centre, Topiwala National Medical College & B. Y. L. Nair Charitable Hospital,
Dr. A. L. Nair Road,
Mumbai.
→ | cvverma100@gmail.com→ | 02223027515→ | Topiwala National Medical College & B. Y. L. Nair Charitable Hospital.→ | Inclusion criteria: <br> Non-Vaccinated for COVID-19 <br/ ><br> <br/ ><br> → | Exclusion criteria: Volunteers not willing to participate→ | | | Responses of the candidates to assess knowledge, attitude and perception towards COVID-19 VaccineTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/03/032028 | 23 March 2021 | An initial study to determine the T lymphocyte response in seriously ill COVID-19 patients: An observational study in Pune, India | A pilot study to determine the T cell immune response in seriously ill COVID-19 subjects: A Pilot observational study in Pune, India - IRCO-19 Study | | Dr D Y Patil Vidyapeeth Pune | 16-03-2021 | 20210316 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53836 | Not Recruiting | No | | | | 01-04-2021 | 40 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Srikanth Tripathy→ | |
Dr. D Y Patil Medical College, Hospital and Research Centre,
Sant Tukaramnagar
Pimpri
Pune-411018
→ | director.medicalresearch@dpu.edu.in→ | 9500779797→ | Dr. D Y Patil Medical College, Hospital and Research Centre→ | Inclusion criteria: <br> Both male and female participants age of 18 years or greater from Pune region, and only who are laboratory confirmed by diagnostic Real-time RT-PCR test with the following features: <br/ ><br> (1) hospitalized requiring supplemental oxygen. <br/ ><br> (2) hospitalized requiring non-invasive ventilation or the use of high-flow oxygen devices. <br/ ><br> (3) hospitalized receiving invasive mechanical ventilation or extracorporeal membrane oxygenation.<br> → | Exclusion criteria: Study participants with other respiratory infections and with underlying infections will be excluded.→ |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | | T cell immune response in severely ill COVID-19 patients at 0 month, 1 month and 6 month time pointsTimepoint: At 0 month, 1 month and 6 month time points→ | | | | Yes | False | | |
| → | CTRI/2021/03/032051 | 23 March 2021 | Trial to evaluate 3mg dose of Covid Vaccine of Cadila healthcare Limited | A prospective, randomized, phase I/II clinical study to evaluate the safety and immunogenicity of 3mg dose of Novel Corona Virus -2019-nCov vaccine candidate of M/s Cadila Healthcare Limited by intradermal route in healthy subjects | | Cadila Healthcare Limited | 16-03-2021 | 20210316 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53226 | Not Recruiting | No | | | | 19-03-2021 | 150 | Interventional |
Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded
→<br> Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded<br> | Phase 1/ Phase 2 | India→ | Dr Jayesh Sanmukhani→ | |
Zydus Corporate Park,
Scheme No. 63, Survey No. 536,
Khoraj (Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad
→ | jayeshsanmukhani@zyduscadila.com→ | 7600012192→ | Cadila Healthcare Ltd.→ | Inclusion criteria: <br> 1. Healthy subject of either gender 18 to 60 years of age <br/ ><br> 2. Informed consent from the subjects (Audio video recording in case of vulnerable subject) <br/ ><br> 3. Adult subjects literate enough to fill the diary card <br/ ><br> 4. Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization), from screening until completion of the follow-up visit and males who agree to use contraception <br/ ><br> → | Exclusion criteria: <br> 1. Febrile illness (temperature â?¥ 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ ><br> 2. History or laboratory evidence of confirmed SARS-CoV-2 positive <br/ ><br> 3. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ ><br> 4. Subjects positive for antibodies against SARS-CoV-2 on antibody detection test / RTPCR positive at the time of screening <br/ ><br> 5. History of SARS/ MERS infection <br/ ><br> 6. Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ ><br> 7. Past history of hypersensitivity reaction or any serious adverse event after any vaccination <br/ ><br> 8. Subjects with thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy <br/ ><br> 9. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy <br/ ><br> 10. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder <br/ ><br> 11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study <br/ ><br> 12. Any other vaccine administration within the last 30 days or planned to be administered during the study period <br/ ><br> 13. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) <br/ ><br> 14. Participation in another clinical trial in the past 3 months <br/ ><br> 15. History of drug / alcohol abuse <br/ ><br> → | | <br> Intervention1: Novel Corona Virus-2019-nCov vaccine of M/s. Cadila Healthcare Limited (ZyCoVD): 3 mg dose (0.1ml dose at three sites) to be given twice at day 0 and 28<br> Control Intervention1: Placebo: 0.1ml dose at three sites to be given twice at day 0 and 28<br>→ | <br> Adverse events (solicited, unsolicited and SAEs) reported during the study in the two groups <br/ ><br> <br/ ><br> Seroconversion rate based on IgG antibodies against S1 antigen (by ELISA) at Day 56. <br/ ><br> Timepoint: Day 56<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/032072 | 23 March 2021 | A study to assess Efficacy and safety of Ayurvedic Kadha in health and immunity related parameters in mild COVID-19 patients. | A Prospective, Single center, single arm study to Evaluate Efficacy and safety of Ayurvedic Kadha in health and immunity related parameters in mild COVID-19 patients. - Kadha | | MARC Laboratories Ltd | 17-03-2021 | 20210317 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53003 | Not Recruiting | No | | | | 19-03-2021 | 50 | Interventional |
Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label
→<br> Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label<br> | Phase 3/ Phase 4 | India→ | Dr Devesh Kumar→ | | Basement Office 1, Building D13, Sector 3 Noida → | devesh.kumar@innovate-research.com→ | 9971169602→ | IR Innovate Research Pvt. Ltd.→ | Inclusion criteria: <br> 1. Age > 18 years <br/ ><br> 2. Written Informed consent is documented <br/ ><br> 3. COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test (RT PCR). <br/ ><br> 4. Can take oral medicines. <br/ ><br> 5. Mild-moderate grade of the disease. <br/ ><br> → | Exclusion criteria: <br> 1. Known sensitivity to any of the ingredients <br/ ><br> 2. Bleeding haemorrhoids <br/ ><br> 3. Serious stages of the illnesses <br/ ><br> 4. ICU admitted patients <br/ ><br> 5. Pre-existing GI symptoms like nausea or vomiting<br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: Ayurvedic Kadha: 2 Drops into 150 ml of water to be taken twice a day for 7 days<br> Control Intervention1: NIL: NIL<br>→ | Clinical status as assessed with the seven-category ordinal scale on days 7 and 14Timepoint: Day1, Day 7 and Day14→ | | | | Yes | False | | |
| → | CTRI/2021/03/032066 | 23 March 2021 | Identifying heart damage in Covid 19 patients - Earlier the better. | Importance of detecting myocardial injury in Covid 19 cases A cross sectional study | | Rajshree Badami | 17-03-2021 | 20210317 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53263 | Not Recruiting | No | | | | 01-04-2021 | 80 | Observational |
Other
Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:
→<br> Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:<br> | N/A | India→ | Rajshree Badami→ | | Department of Biochemistry Rajarajeswari Medical College and Hospital Kambipura Mysore road Bangalore → | drrajshreeb@gmail.com→ | 9164699284→ | Rajarajeswari Medical College and Hospitalita;→ | Inclusion criteria: patients who test positive for Covid-19 by RT-PCR and are admitted to Rajarajeshwari Medical College and Hospital for management.→ | Exclusion criteria: Admitted patients who are newly diagnosed or those having a history of Ischaemic heart disease→ |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Covid 19 Patients with serum CKMB elevation above the upper limit of reference range have poorer prognosisTimepoint: Six months→ | | | | Yes | False | | |
| → | CTRI/2021/03/032067 | 23 March 2021 |
Clinical and biochemical profile of AKI in patients with COVID 19. A single center experience.
|
Correlation of clinical and biochemical profile of AKI in patients with COVID 19. A single center experience.
- COVIDAKI | | Departmental Funds Depaartment of Medicine SMCW Lavale Pune | 17-03-2021 | 20210317 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52536 | Not Recruiting | No | | | | 09-04-2021 | 800 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label<br> | N/A | India→ | Dr Girish Vasudeo Kumthekar→ | | Department of Nephrology, Ext No 1123, Symbiosis Medical College for Women and symbiosis University Hospital and Research Center, Lavale, Pune, Maharashtra, INDIA. Department of Nephrology, Ext No 1123, Symbiosis Medical College for Women and symbiosis Un→ | girish.kumthekar@suhrc.siu.edu.in→ | 7032295272→ | Symbiosis Medical College for Women and symbiosis University Hospital and Research Center→ | Inclusion criteria: <br> a. All adult patients (age more than 18 years) <br/ ><br> b. Diagnosed patients with COVID 19 RT-PCR positivity hospitalized in SUHRC and SMCW, Lavale, Pune. <br/ ><br> <br/ ><br> → | Exclusion criteria: a. Pediatric age group (age less than 18 years)→ |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | <br> a. Occurrence of AKI and related complications in patients admitted with COVID 19. <br/ ><br> b. Occurrence of AKI in COVID 19 patients with rise or fall of other parameters of disease activity like, serum ferritin, CRP, LDH, IL 6.Timepoint: a. At base line <br/ ><br> b. At 48 hours <br/ ><br> c. At 7 days <br/ ><br> d. At 15 days<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/032063 | 23 March 2021 | Understanding of tiredness, level of function and quality of life amongst Post-Covid patients who were admitted in hospitals and asked to be home quarantined | Perception of fatigue, functional status and health related quality of life amongst Post-COVID hospitalized and home quarantined patients | | Researcher Self Funded | 17-03-2021 | 20210317 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53868 | Not Recruiting | No | | | | 22-03-2021 | 30 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Kevin Thakkar→ | | OPD No. 24 N Building Physiotherapy School and Centre Topiwala National Medical College and B Y L Nair Charitable Hospital Dr A L Nair Road Mumbai → | cvverma100@gmail.com→ | 02223027515→ | Topiwala National Medical College and B Y L Nair Charitable Hospital→ | Inclusion criteria: Post-COVID patients who have tested negative in RT-PCR Test more than 3 months and less than 6 months ago→ | Exclusion criteria: Patients not willing to participate in the study, Patients not able to apprehend the questionnaire, Patients having co-morbidities→ |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Fatigue assessment Scale (FAS) to measure Fatigue, Post-COVID functional Status Scale (PCFS) to measure Functional Status and EQ-5D-5L to measure health-related quality of lifeTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/03/032059 | 23 March 2021 | Investigator initiated study to evaluate the effect of Marketed Colchicine 0.5mg given along marketed Asprin 75mg with SOC and Marketed aspirin 75mg with SOC on COVID 19 patients | Investigator initiated, open label, Two Arm Clinical Study (Arm A: Marketed Colchicine 0.5mg given along marketed Asprin 75mg in addition to existing standard of care; Arm B: Marketed aspirin 75mg in addition to existing standard of care) to evaluate the effect on the cardiac & inflammatory biomarkers and clinical prognosis of moderate COVID 19 patients | | SRV Hospital | 17-03-2021 | 20210317 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53115 | Not Recruiting | No | | | | 22-03-2021 | 62 | Interventional |
Other
Method of generating randomization sequence:Other Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
→<br> Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label<br> | N/A | India→ | Dr Vispute Abhay Shantaram→ | |
SRV Hospital, DrMandakiniParihar Marg Opposite LokmanyaTilak
Terminus, Tilak Nagar, Chembur, Mumbai, Maharashtra
→ | surgician@gmail.com→ | 9819428656→ | SRV Hospital→ | Inclusion criteria: <br> 40-80 years old <br/ ><br> Both male and female subjects will be included <br/ ><br> Positive oropharyngeal/nasal swab RT-PCR for Sars-Co-V2. <br/ ><br> Diagnosed not more than 2 days ago diagnosis ?2days. <br/ ><br> Patients with moderate symptoms (moderate symptoms cough, <br/ ><br> weakness fatigue,sore throat,fever >38.50?,clinical signs of <br/ ><br> pneumonia as per PI and features of dyspnea/hypoxia including <br/ ><br> respiratory rate ?24 /min,resting SpO265 <br/ ><br> b Type 2 Diabetes Mellitus <br/ ><br> c Obesity BMI?30 <br/ ><br> d Moderate to severe asthma Appendix I <br/ ><br> e Smoking current or former <br/ ><br> f Cancer active history <br/ ><br> g COPD <br/ ><br> h Chronic heart disease CHF,CAD, cardiomyopathy, pulmonary <br/ ><br> hypertension<br> → | Exclusion criteria: <br> Less than 40 years and older than 80 years <br/ ><br> With severe COVID-19 symptomsrequiring immediate hospitalization <br/ ><br> (Severe COVID-19: pneumonia with respiratory rate >30 <br/ ><br> breaths/min, severe respiratory distress, SpO2 2 days ago <br/ ><br> usingoropharyngeal/nasal swab RT-PCR for Sars-Co-V2 <br/ ><br> History of cardiopulmonary resuscitation <br/ ><br> Patient with a known history of DVT, PE, stroke, atrial <br/ ><br> fibrillation,mechanical heart valve, recent stent placement or any <br/ ><br> other cardiovascular event or any other condition for which the <br/ ><br> patient is takingsystemic anticoagulation/antiplatelet therapy (LMWH, <br/ ><br> coumadin, clopidogrel and/or other similar classes of therapy)prior to <br/ ><br> study enrollment. <br/ ><br> Patients on corticosteroids <br/ ><br> Subjects having history of organ failure or conditions requiring ICU <br/ ><br> monitoring and treatment, such as severe liver disease, severe renal <br/ ><br> dysfunction, upper gastrointestinal hemorrhage, disseminated <br/ ><br> intravascular coagulation or any other condition that in the PIâ??s <br/ ><br> opinion makes the subject unfit to participate <br/ ><br> Respiratory failure, ARDS or need of immediate mechanical <br/ ><br> ventilation upon presentation <br/ ><br> History of acute exacerbation of comorbidity like heart failure, <br/ ><br> diabetic ketoacidosis, myocardial infection, major cardiac rhythm <br/ ><br> disorder or any other condition that in the PIâ??s opinion makes the <br/ ><br> subject unfit to participate <br/ ><br> History of or current hepatic failure or severely compromised liver <br/ ><br> function, or renal failure or having chronic kidney disease or acute <br/ ><br> renal failure <br/ ><br> History of or currently receiving treatment for an endocrine disorder <br/ ><br> like hypothyroidism, hyperthyroidism that is likely to affect the basal <br/ ><br> heart rate. <br/ ><br> HIV, HBsAg, HCV positive <br/ ><br> Any condition causing immunodeficiency <br/ ><br> Systemic connective tissue disease or any autoimmune disease that <br/ ><br> is likely to affect HS-CRP levels <br/ ><br> History of epilepsy/epileptic fit/convulsions in last 6 months or <br/ ><br> currently on treatment for it <br/ ><br> History of or currently having malignancy and being treated for <br/ ><br> it.exception histologically confirmed and cured carcinoma in situ <br/ ><br> Hypersensitivity reaction to Study drug/active control <br/ ><br> Any psychiatric issue for which the subject is currently undergoing <br/ ><br> treatment <br/ ><br> Any history of drug/alcohol dependence within 30 days of screening <br/ ><br> or current drug/alcohol dependence <br/ ><br> Inability to understand the requirements of the Research Protocol <br/ ><br> and follow the research procedures. <br/ ><br> Pregnant or lactating <br/ ><br> Not willing to use adequate contraception during stu→ |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: Marketed Colchicine 0.5mg given along marketed Asprin 75mg with SOC: Marketed Colchicine 0.5mg given along marketed Asprin 75mg with SOC twice daily and SOC<br> Control Intervention1: Marketed aspirin 75mg with SOC: Marketed aspirin 75mg with twice daily and<br> plus SOC.<br>→ | <br> 1 To evaluate the efficacy of marketed colchicine 0.5 mg plus marketed Aspirin 75 mg given twice daily at the same time in the management <br/ ><br> of inflammation and thrombotic condition of <br/ ><br> moderate COVID-19 disease through the <br/ ><br> specific biomarkers <br/ ><br> 2. To evaluate the symptomatic improvement <br/ ><br> through the NEWS score and 8-point ordinal <br/ ><br> scoreTimepoint: First Treatment day up to 15 days<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/032065 | 23 March 2021 | A study to assess patient satisfaction and experience at a tertiary care hospital during the Covid-19 pandemic | Impact of COVID-19 pandemic on patient satisfaction and experience | | Amritha Sreeshma R | 17-03-2021 | 20210317 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53939 | Not Recruiting | No | | | | 29-03-2021 | 300 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Amritha Sreeshma R→ | |
Amritha Sreeshma R
Department of Hospital Administration.
Prasanna School of Public Health, MAHE, Manipal, Karnataka, India Tiger Circle Road,
Madhav Nagar, Manipal, Karnatak→ | somu.g@manipal.edu→ | 9448463186→ | Manipal Academy of Higher Education→ | Inclusion criteria: In patients and Out patients who are fully awake and follow up patients are included→ | Exclusion criteria: Patients who are not willing to participate, suspected/positive COVID-19 patients and below 18 years old are excluded.→ |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Patient satisfaction level during Covid-19 pandemicTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/03/032086 | 23 March 2021 | To study the mental health status, job satisfaction and quality of sleep among nursing staff during COVID 19 pandemic | To study the level of perceived stress, Job satisfaction, quality of sleep among nursing staff and compare with various cadre of nursing staff. | | Dr Santosh Ramdurg | 17-03-2021 | 20210317 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52929 | Not Recruiting | No | | | | 20-03-2021 | 400 | Observational |
Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label
→<br> Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label<br> | N/A | India→ | DR SANTOSH RAMDURG→ | |
DEPT OF OBG
OPD NO 2
BLDE HOSPITAL AND RESEARCH CENTRE,
VIJAYAPURA DEPT OF PSYCHIATRY
BLDE HOSPITAL AND RESEARCH CENTRE,
VIJAYAPURA
→ | santoshramdurg@gmail.com→ | 9611281386→ | BLDE HOSPITAL AND RESEARCH HOSPITAL→ | Inclusion criteria: All the nursing staff working within the institute and those who are working in private set-up around Vijayapura and surrounding places→ | Exclusion criteria: no specific criteria→ |
Health Condition 1: Z208- Contact with and (suspected) exposure to other communicable diseases
→ | | to study the metal state of the nursing staff under the conditions of Covid -19Timepoint: o weeks , 4 weeks , 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/03/032060 | 23 March 2021 |
Investigator initiated study to evaluate the effect of Marketed Colchicine 0.5mg given along
marketed Asprin 75mg with SOC and Marketed aspirin 75mg with SOC on COVID 19 patients
|
Investigator initiated, open label, Two Arm Clinical Study (Arm A: Marketed Colchicine 0.5mg given
along marketed Asprin 75mg in addition to existing standard of care; Arm B: Marketed aspirin 75mg
in addition to existing standard of care) to evaluate the effect on the cardiac & inflammatory
biomarkers and clinical prognosis of moderate COVID 19 patients
| | Govt Medical College Govt General Hospital | 17-03-2021 | 20210317 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53231 | Not Recruiting | No | | | | 22-03-2021 | 62 | Interventional |
Other
Method of generating randomization sequence:Other Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label
→<br> Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label<br> | N/A | India→ | Dr K Sunil Naik→ | |
Research wing, Second
floor beside FM ward
Govt. Medical College
& Govt. General
Hospital (Old
RIMSGGH),
Srikakula→ | drsunilnaikggh@gmail.com→ | 9912320517→ | Govt. Medical College & Govt. General Hospital→ | Inclusion criteria: <br> 40-80 years old Both male and female subjects will be included Positive oropharyngeal/nasal swab RT-PCR for Sars-Co-V2.Diagnosed not more than 2 days ago diagnosis <br/ ><br> >2days.Patients with moderate symptoms (moderate symptoms cough,weakness fatigue,sore throat,fever <br/ ><br> >38.50C,clinical signs ofpneumonia as per PI and features of <br/ ><br> dyspnea/hypoxia including, respiratory rate greater than equal to 24 /min,resting <br/ ><br> SpO265, Type 2 Diabetes Mellitus Obesity <br/ ><br> BMI >30 <br/ ><br> Moderate to severe asthma Appendix I <br/ ><br> Smoking current or former Cancer active history <br/ ><br> COPD, Chronic heart disease CHF,CAD, cardiomyopathy, <br/ ><br> pulmonary hypertension<br> → | Exclusion criteria: <br> Less than 40 years and older than 80 years <br/ ><br> With severe COVID-19 symptomsrequiring immediate hospitalization <br/ ><br> (Severe COVID-19: pneumonia with respiratory rate >30 <br/ ><br> breaths/min, severe respiratory distress, SpO2 2 days ago <br/ ><br> usingoropharyngeal/nasal swab RT-PCR for Sars-Co-V2 <br/ ><br> History of cardiopulmonary resuscitation <br/ ><br> Patient with a known history of DVT, PE, stroke, atrial <br/ ><br> fibrillation,mechanical heart valve, recent stent placement or any <br/ ><br> other cardiovascular event or any other condition for which the <br/ ><br> patient is takingsystemic anticoagulation/antiplatelet therapy (LMWH, <br/ ><br> coumadin, clopidogrel and/or other similar classes of therapy)prior to <br/ ><br> study enrollment. <br/ ><br> Patients on corticosteroids <br/ ><br> Subjects having history of organ failure or conditions requiring ICU <br/ ><br> monitoring and treatment, such as severe liver disease, severe renal <br/ ><br> dysfunction, upper gastrointestinal hemorrhage, disseminated <br/ ><br> intravascular coagulation or any other condition that in the PIâ??s <br/ ><br> opinion makes the subject unfit to participate <br/ ><br> Respiratory failure, ARDS or need of immediate mechanical <br/ ><br> ventilation upon presentation <br/ ><br> History of acute exacerbation of comorbidity like heart failure, <br/ ><br> diabetic ketoacidosis, myocardial infection, major cardiac rhythm <br/ ><br> disorder or any other condition that in the PIâ??s opinion makes the <br/ ><br> subject unfit to participate <br/ ><br> History of or current hepatic failure or severely compromised liver <br/ ><br> function, or renal failure or having chronic kidney disease or acute <br/ ><br> renal failure <br/ ><br> History of or currently receiving treatment for an endocrine disorder <br/ ><br> like hypothyroidism, hyperthyroidism that is likely to affect the basal <br/ ><br> heart rate. <br/ ><br> HIV, HBsAg, HCV positive <br/ ><br> Any condition causing immunodeficiency <br/ ><br> Systemic connective tissue disease or any autoimmune disease that <br/ ><br> is likely to affect HS-CRP levels <br/ ><br> History of epilepsy/epileptic fit/convulsions in last 6 months or <br/ ><br> currently on treatment for it <br/ ><br> History of or currently having malignancy and being treated for <br/ ><br> it.exception histologically confirmed and cured carcinoma in situ <br/ ><br> Hypersensitivity reaction to Study drug/active control <br/ ><br> Any psychiatric issue for which the subject is currently undergoing <br/ ><br> treatment <br/ ><br> Any history of drug/alcohol dependence within 30 days of screening <br/ ><br> or current drug/alcohol dependence <br/ ><br> Inability to understand the requirements of the Research Protocol <br/ ><br> and follow the research procedures. <br/ ><br> Pregnant or lactating <br/ ><br> Not willing to use adequate contraception during stu→ |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | <br> Intervention1: Marketed Colchicine 0.5mg<br> given along marketed Asprin<br> 75mg with SOC: Marketed Colchicine 0.5mg<br> given along marketed Asprin<br> 75mg with SOC twice daily and<br> SOC<br> Control Intervention1: Marketed aspirin 75mg with<br> SOC: Marketed aspirin 75mg with<br> twice daily and plus SOC.<br>→ | <br> 1 To evaluate the efficacy of marketed colchicine <br/ ><br> 0.5 mg plus marketed Aspirin 75 mg given twice <br/ ><br> daily at the same time in the management <br/ ><br> of inflammation and thrombotic condition of <br/ ><br> moderate COVID-19 disease through the <br/ ><br> specific biomarkers <br/ ><br> 2. To evaluate the symptomatic improvement <br/ ><br> through the NEWS score and 8-point ordinal <br/ ><br> scoreTimepoint: First Treatment day day 1 and 15 days<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/032135 | 23 March 2021 | Effectiveness of spirometry and neurophysiological facilitation technique to reduce the level of dyspnea in post covid-19 patient-A randomized controlled trial | Efeect of spirometry and neurophysiological facilitation technique to reduce the level of dyspnea in post covid-19 patient - a randomized controlled trial - NIL | | Patel Preet Sureshbhai | 18-03-2021 | 20210318 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51532 | Not Recruiting | No | | | | 25-03-2021 | 45 | Interventional |
Randomized, Parallel Group Trial
Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Participant Blinded
→<br> Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Not Applicable Blinding and masking:Participant Blinded<br> | N/A | India→ | Dr Priyanka Chaudhary→ | |
OPD-6 Cardio-Respiratory Department
OPD-6 Cardio-Respiratory Department
Nootan College Of Physiotherapy
→ | priyankkachaudhary@gmail.com→ | 8469956731→ | Nootan College of Physiotherapy Sankalchand Patel University→ | Inclusion criteria: <br> Patients who recovered from COVID-19 <br/ ><br> According to modified borg scale patient with score greater than or equal 2 to 10 <br/ ><br> Between period of 8-12 week after recovering from COVID-19<br> → | Exclusion criteria: <br> Geriatric age group <br/ ><br> According to modified borg dyspnea scale patients with score 0 to 1 <br/ ><br> Patients with other disorder and diseases<br> → |
Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B968- Other specified bacterial agents as the cause of diseases classified elsewhere
Health Condition 3: J988- Other specified respiratory disorders
Health Condition 4: F- Physical Rehabilitation and Diagnostic Audiology
→ | <br> Intervention1: 6 Minute walk Test<br> Modified Borg Scale<br> Spirometry<br> 3 weeks: 6 Minute walk Test to check physical endurance<br><br> Modified Borg Scale to asses the dyspnes level<br><br> Spirometry<br> to check and increase the vital capacity<br><br> Control Intervention1: 6 Minute Walk Test<br> Modified Borg Scale<br> 3 weeks<br> : 6 Minute Walk Test<br> to check physical endurance<br> Modified Borg Scale<br> to assess the dyspnea level<br>→ | <br> Modified Borg Scale <br/ ><br> 6-Minutes walk testTimepoint: 3 Weeks<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/032159 | 23 March 2021 | Mental health of pregnant women during the covid 19 pandemic | Mental health of pregnant women during covid 19 pandemic | | Dr S R Mudanur | 19-03-2021 | 20210319 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52882 | Not Recruiting | No | | | | 01-04-2021 | 200 | Observational |
Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Dr S R Mudanur→ | |
OBG Department
Shri BM Patil Medical College and Research Center
Solapur Rd, Bangaramma Sajjan Campus OBG Department
Shri BM Patil Medical College and Research Center
→ | drmudanurs@gmail.com→ | | Shri BM Patil Medical College→ | Inclusion criteria: All pregnant women attending OPD for ANC checkup within private sector/govt setting in Vijayapura→ | Exclusion criteria: → |
Health Condition 1: F59- Unspecified behavioral syndromes associated with physiological disturbances and physical factors
→ | | <br> Socio-demographic scale <br/ ><br> Depression Anxiety stress scale <br/ ><br> IES-R25Timepoint: 12 weeks<br> → | | | | Yes | False | | |
| → | CTRI/2021/03/032158 | 23 March 2021 | Effects of Covieshield vaccine on Liver cirrhosis patients | Safety and Efficacy of a Non-replicating ChAdOx1 Vector Vaccine AZD1222 (COVISHIELD), for Prevention of COVID-19 in Patients With Liver Cirrhosis - An Interventional Study | | Institute of Liver and Biliary Sciences | 19-03-2021 | 20210319 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54015 | Recruiting | No | | | | 24-03-2021 | 2200 | Interventional |
Non-randomized, Active Controlled Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable
→<br> Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable<br> | N/A | India→ | Dr Shantan Venishetty→ | | Room No 3330, Department of Hepatology, Phase II, 3rd Floor, Institute of Liver and Biliary Sciences, D-1, Vasant Kunj New Delhi-110070 → | venishantan@gmail.com→ | 01146300000→ | Institute of Liver and Biliary Sciences→ | Inclusion criteria: <br> The following patients will be enrolled in the study under Group 1: <br/ ><br> <br/ ><br> <br/ ><br> 1) Evidence of liver cirrhosis established during the clinical investigations and/or hospital stay, as evidenced by clinical, endoscopic, radiological and/or histological criteria. <br/ ><br> 2) Baseline Negative SARS-COV19 IgG neutralizing antibodies. <br/ ><br> <br/ ><br> The following patients (healthy controls) will be enrolled in the study: <br/ ><br> <br/ ><br> 1) Baseline Negative SARS-COV19 IgG neutralizing antibodies <br/ ><br> 2) No previous COVID-19 infection <br/ ><br> 3) No major respiratory, cardiac comorbid illnesses or malignancy or immunosuppressed state<br> → | Exclusion criteria: <br> 1. Planned receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination with the exception of the licensed seasonal influenza vaccination and the licensed pneumococcal vaccine. Participants will be encouraged to receive this vaccination at least 7 days before or after their study vaccine. <br/ ><br> 2. Prior or concomitant vaccine therapy for COVID-19 <br/ ><br> 3. ICU patients <br/ ><br> 4. Hemodynamically unstable patients, shock <br/ ><br> 5. Significant encephalopathy, acute kidney injury <br/ ><br> 6. Documented or suspected sepsis including chest infection <br/ ><br> 7. ACLF (Acute on Chronic Liver Failure) <br/ ><br> 8. Significant cardiac or respiratory co-morbidities <br/ ><br> 9. Known allergy to vaccination <br/ ><br> 10. Prior receipt of an investigational or licensed vaccine likely to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus vaccines). <br/ ><br> 11. History of allergic disease or reactions likely to be exacerbated by any component of the AZD1222 (Covishield) vaccine. <br/ ><br> 12. Any history of angioedema. <br/ ><br> 13. Any history of anaphylaxis. <br/ ><br> 14. Pregnancy, lactation or willingness/intention to become pregnant during the study. <br/ ><br> 15. Any other serious chronic illness requiring hospital specialist supervision. <br/ ><br> 16. Currently or in last 3 weeks have: fever/cough/sorethroat/rhinorrhea/hemoptysis/breathlessness/chest pain/myalgia/nausea/vomiting/diarrhea/abdominal pain/loss of taste.<br> → |
Health Condition 1: K746- Other and unspecified cirrhosis ofliver
→ | <br> Intervention1: Covieshield in Liver Cirrhosis: 2 IM doses (0.5 mL) of AZD1222(Covishield) at Day 0 and Day 28<br> Control Intervention1: Covieshield in Healthy Subjects: 2 IM doses (0.5 mL) of AZD1222(Covishield) at Day 0 and Day 28<br>→ | <br> To evaluate the efficacy, safety and tolerability of AZD1222(Covishield) (2 doses) in patients with liver cirrhosis. <br/ ><br> Efficacy of the the vaccine is defined as proportion of patients with presence of antibodies titres compared with the control group.Timepoint: 6 months<br> → | | | | Yes | False | | |
| NCT04325906 | 3 May 2021 | Early PP With HFNC Versus HFNC in COVID-19 Induced Moderate to Severe ARDS | Early Prone Positioning Combined With High-Flow Nasal Cannula Versus High-Flow Nasal Cannula in COVID-19 Induced Moderate to Severe ARDS | | Rush University Medical Center | 26/03/2020 | 20200326 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04325906 | Not recruiting | No | 18 Years | N/A | All | April 2, 2020 | 222 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United States | | Jie Li, PhD | | | | Rush University Medical Center |
<br> Inclusion Criteria:
<br>
<br> - COVID-19 induced adult ARDS patients admitted to the medical ICU
<br>
<br> - PaO2/FiO2 is less than 200mmHg or FIO2 = 0.4 is required to maintain SpO2 at 88-93% on
<br> HFNC treatment
<br>
<br> Exclusion Criteria:
<br>
<br> 1. If the patients have a consistent SpO2<80% when on evaluation with a FiO2 of 0.6, or
<br> signs of respiratory fatigue (RR > 40/min, PaCO2> 50mmHg / pH<7.30, and obvious
<br> accessory respiratory muscle use);
<br>
<br> 2. Immediate need for intubation (PaO2/FiO2< 50mmHg or SpO2/FiO2 <90, unable to protect
<br> airway or mental status change);
<br>
<br> 3. unstable hemodynamic status(SBP<90mmHg, MBP below 65 mmHg or requirement for
<br> vasopressor);
<br>
<br> 4. unable to collaborate with HFNC/PP with agitation or refuse HFNC/PP.
<br>
<br> 5. chest trauma or any contraindication for PP
<br>
<br> 6. pneumothorax
<br>
<br> 7. age < 18 years
<br> | | Prone Positioning;High Flow Nasal Cannula;Acute Respiratory Distress Syndrome;Corona Virus Infection | Device: high flow nasal cannula (HFNC);Procedure: Prone positioning (PP) | mortality;Intubation rate;Treatment failure (intubation or death) | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2021-000930-32-BE | 3 May 2021 | COVID-19: Determination of effect of COVID vaccination on immunity of hemodialysis patients | COVID-19: Documentation of humoral and cellular immune response of hemodialysis patients after vaccination against SARS-CoV-2 - COVID-19: immune response after COVID-vaccination in hemodialysis patients | | AZ Sint-Jan Brugge-Oostende AV | 04/03/2021 | 20210304 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000930-32 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 27/04/2021 | 580 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>Other trial design description: the trial follows the routine practice of COVID-vaccination, except for additional blood sampling<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: other pathology - hemodialysis vs comorbidity vs healthy controls<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Belgium | CTC | | Ruddershove 10 | ctc@azsintjan.be | 003250453289 | clinical trial center | Inclusion criteria: <br>1. Consecutive series of hemodialysis patients receiving Covid-19 RNA<br>vaccine. A target of at least 100 patients is envisioned. Minimum age for<br>inclusion is 18 years.<br>2. at least thirty healthy volunteers receiving Covid-19 RNA vaccine.<br>Minimum age for inclusion is 18 years. Individuals with immune<br>disorders cannot participate.<br>3. at least thirty patients older than 50 years with at least 1<br>comorbidity (such as heart failure, diabetes, COPD, liver cirrhosis,....),<br>but no chronic renal insufficiency. Minimum age for inclusion is 18 years.<br>Only patients who receive vaccine on a voluntary basis will be included.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 550<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 30<br> | Exclusion criteria: <br>- patients younger than 18 years old<br>- patients who do not voluntarily ask for a COVID-vaccination<br>- patients not eligible according to abovementioned inclusion criteria<br> | hemodialysis patients
hemodialysis patients with comorbidities;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Trade Name: Comirnaty concentrate for dispersion for injection<br>COVID-19 mRNA Vaccine (nucleoside modified)<br>Pharmaceutical Form: Concentrate and solvent for solution for injection<br>INN or Proposed INN: NAP<br>CAS Number: 2417899-77-3<br>Current Sponsor code: BNT162b2<br>Other descriptive name: Tozinameran<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 0.01-<br><br>Trade Name: COVID-19 Vaccine Moderna dispersion for injection<br>COVID-19 mRNA Vaccine (nucleoside modified)<br>Pharmaceutical Form: Concentrate and solvent for solution for injection<br>INN or Proposed INN: CX-024414<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 0.2-<br><br> | Main Objective: In this trial we aim to measure the humoral and immune response after<br>vaccination with one of 2 types of COVID-19 vaccines, recently approved<br>by the EMA for use in the European Union: the BNT162b2 mRNA COVID-<br>19 vaccine from BioNTec/Pfizer and the SARS-CoV-2 mRNA-1273 vaccine<br>from Moderna. This in hemodialysis patients of 18 years and older, in<br>comparison with patients with comorbidities and healthy volunteers.<br>Blood sampling will be performed during dialysis via catheter or AV<br>fistula. In the healthy volunteers and patients with comorbidities, blood<br>will be drawn. Exact timing of blood draws will be point zero (day of<br>vaccination to 1 week before vaccine administration), and 4 weeks (+/-3<br>days), 8 weeks (+/-3 days) and 24 weeks (+/-3 days) after vaccine<br>administration.<br>Patients will be recruited in Belgium in the following hospitals: AZ Sint-<br>Jan Brugge-Oostende AV (coordinating site), Zuid-Oost Limburg, AZ<br>Groeninge, OLV Aalst, and curando vzw.;Secondary Objective: analysis of predictive factors (clinical and immunological) for the<br>immune response in hemodialysis patients;Primary end point(s): 1. Measurement of anti-S and anti-N antibodies.<br>SARS-CoV-2 IgG against the S and N protein will be quantitatively<br>measured by chemiluminescent microparticle immunoassay (Architect-I<br>System by Abbott, Sligo, Ireland).<br>2. Measurement of interferon gamma production.<br>Interferon production by SARS-CoV specific T cells will be measured<br>using the QuantiFERON Sars-CoV-2 kit (Qiagen).<br>3. Baseline immune status (only in hemodialysis patients).<br>Before vaccination the following parameters are determined: number of<br>lymphocytes, number of CD4 positive lymphocytes, number of CD8<br>positive lymphocytes, number of CD19 positive lymphocytes, B and T cell<br>memory subsets, protein electrophoresis, C3, C4, total IgG, IgA and IgM.;Timepoint(s) of evaluation of this end point: Time of blood sampling is point zero (day of vaccination to 1 week<br>before vaccine administration), and 4 weeks (+/-3 days), 8 weeks (+/-3<br>days) and 24 weeks (+/-3 days) after vaccine administration. | | | | Yes | False | | |
| → | EUCTR2020-005580-32-AT | 3 May 2021 | Pilot study on silibinin as a possible therapeutic agent for mildly ill COVID-19 patients | Pilot study on silibinin as a possible therapeutic agent for mildly ill COVID-19 patients | | Medical University of Vienna | 15/04/2021 | 20210415 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005580-32 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 26/04/2021 | 30 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: no<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Austria | Peter Ferenci | | Währinger Gürtel 18-20 | peter.ferenci@meduniwien.ac.at | 0043140400 47440 | Medical University of Vienna | Inclusion criteria: <br>Patients with mild COVID-19 disease without the need for assisted ventilation<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 15<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 15<br> | Exclusion criteria: <br>Need for assisted ventilation<br> | antiviral effect of silibinin against SARS-CoV2;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Legalon SIL<br>Product Name: Legalon SIL<br>Pharmaceutical Form: Lyophilisate for solution for infusion<br>INN or Proposed INN: Silibinin-C-2’, 3-bis (hydrogensuccinat)<br>Other descriptive name: Silibinin dihemisuccinate disodium<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 350-<br><br> | Timepoint(s) of evaluation of this end point: day10;Primary end point(s): Viral decay on day 10 or undetectable virus by PCR at any time before day 10;Secondary Objective: Not applicable;Main Objective: antiviral treatment of mild COVID-19 disease with silibinin by examining viral elimination kinetics→Main Objective: antiviral treatment of mild COVID-19 disease with silibinin by examining viral elimination kinetics;Secondary Objective: Not applicable;Primary end point(s): Viral decay on day 10 or undetectable virus by PCR at any time before day 10;Timepoint(s) of evaluation of this end point: day10 | | | | Yes | False | | |
| EUCTR2021-000492-36-BE | 3 May 2021 | Home and?Outpatients?Precocious?Eradication of?COVID-19 | Home and?Outpatients?Precocious?Eradication of?COVID-19 - HOPE COVID-19 | | UCLouvain | 21/04/2021 | 20210421 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000492-36 | Not Available | No | | | <br>Female: yes<br>Male: yes<br> | | 104 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Belgium | | | | | | Centre académique de médecine générale | Inclusion criteria: <br>- Provided informed consent following an exhaustive and fully-understood information
<br>- Aged =16 years and =65 years
<br>- Does not present any criteria of redirection towards the Emergency Room or towards a direct hospitalization
<br>- Time from symptom onset (TFSO) =48 hours AND tested positive at the Rapid Antigenic Test
<br><br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: 10<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 94<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>- Pregnancy, breastfeeding, or any woman of child-bearing potential that does not benefit from any proper contraception and whose Last Menstrual Period occurred 20 days ago or more (= 20 days).
<br>- Immunosuppression, whatever the type, including drug-induced cases.
<br>- COVID-19 requiring hospitalization or redirection towards the Emergency Room.
<br>- Anti-COVID-19 vaccination, whatever the vaccine, as soon as first dose has been administered.
<br>- Former COVID-19 infection diagnosed upon positive SARS-CoV-2 RT-PCR test results.
<br>
<br><br> | COVID-19 <br>MedDRA version: 23.0
Level: LLT
Classification code 10084382
Term: Coronavirus disease 2019
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Siroxyl sans sucre pour adultes 750 mg/15ml solution buvable<br>Pharmaceutical Form: Oral solution<br>INN or Proposed INN: carbocysteine<br>CAS Number: 638-23-3<br>Current Sponsor code: HOPE-01-V<br>Other descriptive name: CARBOCISTEINE LYSINE<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 750-<br>Pharmaceutical form of the placebo: Syrup<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: after full treatment completion;Primary end point(s): Rate, in percent, of subjects in each investigation arm displaying a SARS-CoV-2 RT-PCR Ct count above 34 (>34 cycles) performed on a saliva sample collected at Day 6 of experiment;Secondary Objective: 1)Clinical evolution based on the daily filling of the FLU-PRO self-questionnaire (daily comparison of the distribution and mean of FLU-PRO score in each investigation arm)<br>2)Rate of subjects in each investigation arm displaying a negative viral culture of a nasopharyngeal swab sample collected at Day 3 of experiment<br>3)Median time, in days, of viral shedding in the subjects in each investigation arm (time of viral shedding=nb of days in experiment of a saliva sample which RT-PCR Ct count is >34)<br>4)Evolution of the daily distribution and mean RT-PCR Ct count compared between the two investigation arms, performed on saliva samples collected daily in all the subjects, from Day 1 to Day 6<br>5)Rate of subjects in each investigation arm having reported any kind of adverse events and reactions including specific comparison according to :<br>- the organic system they affect, be it encompassed by the table in Appendix 2 or not ;<br>- their quality and severity class : AE, SAE, SUSAR<br>;Main Objective: Rate, in percent, of subjects in each investigation arm displaying a SARS-CoV-2 RT-PCR Ct count above 34 (>34 cycles) performed on a saliva sample collected at Day 6 of experiment, after full treatment completion. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04746430 | 17 May 2021 | COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study | COVID-19 Primary Care Platform for Early Treatment and Recovery (COPPER) Study: an Open-label Randomized Controlled Trial | COPPER | General Practitioners Research Institute | 08/02/2021 | 20210208 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04746430 | Not recruiting | No | 18 Years | N/A | All | February 16, 2021 | 17 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 4 | Netherlands | | Janwillem Kocks, Prof | | | | General Practitioners Research Institute |
<br> Inclusion Criteria:
<br>
<br> - Age =18 years
<br>
<br> - A positive test for SARS-CoV-2
<br>
<br> - A GP consultation for deteriorating COVID-19 symptoms
<br>
<br> Additional inclusion criteria in order to be eligible for randomization to the trial:
<br>
<br> - Exercise-induced desaturation, defined as SpO2<92% (<90% for COPD patients) and/or an
<br> absolute drop of =4% in SpO2 after a 1-minute sit-to-stand test
<br>
<br> OR
<br>
<br> - SpO2<92% (<90% for COPD patients) in rest with GP's and patient's shared decision to keep
<br> patient at home despite this in itself being an indication for referral to hospital
<br>
<br> Exclusion Criteria:
<br>
<br> - Inability to understand and sign the written consent form
<br>
<br> - Inability to perform saturation measurements or sit-to-stand test
<br>
<br> - Not willing to be admitted to hospital
<br>
<br> - On the discretion of the recruiting clinician if he or she deems a patient not
<br> eligible
<br>
<br> The following criterion will be used to exclude patients from randomization to the trial:
<br>
<br> - Contra-indication for dexamethasone
<br> | | Covid19;Corona Virus Infection | Drug: Dexamethasone | Hospitalization/death | | | | Yes | False | | |
| → | NCT04753645 | 17 May 2021 | BRAC Institute of Governance and Development-Hygiene Behavioural Change and Coalition | The Effect of Public Handwashing Stations on Health Behaviour and Outcomes During COVID-19 | (BIGD-HBCC) | BRAC University | 11/02/2021 | 20210211 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04753645 | Not recruiting | No | 10 Years | N/A | All | September 19, 2020 | 3840 | Interventional | Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | Bangladesh | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Must live in the villages where BRAC is implementing the interventions
<br>
<br> Exclusion Criteria:
<br>
<br> -
<br> | | Hygiene Practices and Knowledge | Behavioral: Handwashing stations at the public places and no soap;Behavioral: No activities of the HBCC project and also no soap (Pure Control);Behavioral: Soap distributed but no activities of the HBCC project;Behavioral: HBCC project and Soap | Prevalence of transmissible diseases in the past 15 days;Likelihood of using soap when handwashing;Daily handwashing frequency→Daily handwashing frequency;Likelihood of using soap when handwashing;Prevalence of transmissible diseases in the past 15 days | | | | No | False | | |
| NCT04757207 | 17 May 2021 | Pandemia And Exercise in Turkey in University Students of Turkey | The Effect of Pandemia on Making Exercise In University Students of Turkey | | GULIN FINDIKOGLU | 13/02/2021 | 20210213 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04757207 | Not recruiting | No | 17 Years | 40 Years | All | February 22, 2021 | 5474 | Observational | | | Turkey | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Being a university student
<br>
<br> - Having sufficient device infrastructure (cell phone or computer) to access the
<br> electronic survey
<br>
<br> Exclusion Criteria:
<br>
<br> - Entering incorrect numbers for answers
<br>
<br> - Those who have a disease / disability that prevents them from walking and exercising
<br> | | Sedentary Behavior;Covid19 | Other: survey | International Physical Activity Score (short form) MEt-min/week | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04866589 | 17 May 2021 | COVID-19: The Effectiveness of Free Face Mask Distribution | The Effectiveness of Distributing Free Face Masks to Increase Use of Face Masks During the COVID-19 Pandemic. A Randomised Experiment in Stovner District, Oslo, Norway | | Norwegian Institute of Public Health | 15/04/2021 | 20210415 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04866589 | Not recruiting | No | 12 Years | N/A | All | May 3, 2021 | 10 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | | ; | Atle Fretheim, PhD;Atle Fretheim, PhD | | ;atle.fretheim@fhi.no | ;+4791649828 | Norwegian Institute of Public Health; |
<br> All grocery stores in the Stovner district are eligible as long as they have not, or only
<br> sporadically, had free distribution of face masks previously.
<br>
<br> At the customer level, we will only include those 12 years or older (age based on the
<br> outcome assessor's judgement).
<br> | | Covid19 | Behavioral: Distribution of free face masks | Face mask use | | | | Yes | False | | |
| → | NCT04869592 | 17 May 2021 | A Clinical Trial to Evaluate the Recombinant SARS-CoV-2 Vaccine (CHO Cell) for COVID-19 | Phase I/II Clinical Trial to Evaluate the Safety, Tolerability and Immunogenicity of Recombinant SARS-CoV-2 Vaccine (CHO Cell) in Healthy People Aged 3 Years and Older | | National Vaccine and Serum Institute, China | 24/04/2021 | 20210424 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04869592 | Recruiting | No | 3 Years | N/A | All | April 25, 2021 | 3580 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 1/Phase 2 | China | ; | shengli Xia, bachelor;ling Lv | | 1792865518@qq.com;nlghk@163.com | (+86)13592610137;(+86)15993409079 | |
<br> Inclusion Criteria:
<br>
<br> - Age range: healthy people aged 3 years and and older who can provide legal
<br> identification;
<br>
<br> - The subject and/or his legal guardian and/or his entrusted person can understand the
<br> study procedures and informed consent, voluntarily sign informed consent form, and be
<br> able to comply with the requirements of the clinical study protocol;
<br>
<br> - Inquired about medical history and physical examination, the investigator judged that
<br> the health condition is good;
<br>
<br> - No history of SARS-CoV-2 vaccination before enrollment;
<br>
<br> - Females of childbearing age (menarche to menopause) are not pregnant at the time of
<br> enrollment (negative urine pregnancy test), not breastfeeding, and have no birth plan
<br> within 12 months after enrollment; effective contraception will be taken within 2
<br> weeks before enrollment;
<br>
<br> - During the entire study follow-up period, be able and willing to complete the entire
<br> prescribed study plan.
<br>
<br> Exclusion Criteria:
<br>
<br> First Dose Exclusion Criteria:
<br>
<br> - Confirmed cases of SARS-CoV-2 infection, suspected cases, asymptomatic infections, or
<br> close contacts with the above population (check "China Disease Prevention and Control
<br> Information System");
<br>
<br> - Axillary body temperature is not less than 37.3? (older than 14 years) before
<br> vaccination, and axillary body temperature is not less than 37.5? (14 years or
<br> younger) before vaccination;
<br>
<br> - Positive in SARS-CoV-2 IgG and IgM antibody screening;
<br>
<br> - Have a history of SARS virus infection (self-report, on-site inquiry);
<br>
<br> - Fever (axillary temperature is not less than 37.3?), dry cough, fatigue, nasal,
<br> congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, or
<br> dyspnea within 14 days before vaccination;
<br>
<br> - Before vaccination, the results of blood biochemistry, blood routine, urine routine,
<br> and coagulation function related indexes are abnormal, which exceed the reference
<br> value range, and have clinical significance abnormalities (only refers to phase I);
<br>
<br> - Previous severe allergic reaction to vaccination (such as acute allergic reaction,
<br> urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain);
<br>
<br> - Allergic to any component of the study vaccine (such as aluminum, histidine, etc.);
<br>
<br> - Have a history of convulsions, epilepsy, encephalopathy, long-term alcoholism and drug
<br> abuse, thyroidectomy, infectious diseases, mental illness or family history;
<br>
<br> - Congenital malformations or developmental disorders, genetic defects, severe
<br> malnutrition, etc;
<br>
<br> - Known or suspected diseases include: severe respiratory disease, severe liver and
<br> kidney disease, severe cardiovascular disease, drug-uncontrollable hypertension
<br> (systolic blood pressure is not less than 140mmHg, diastolic blood pressure is not
<br> less than 90mmHg), high blood glucose, diabetic complications , Malignant tumors,
<br> various acute diseases or acute attacks of chronic diseases;
<br>
<br> - Have been diagnosed with congenital or acquired immunodeficiency, HIV infection,
<br> lymphoma, leukemia or other autoimmune diseases;
<br>
<br> - Have a history of abnormal coagulation function (such as coagulation factor
<br> deficiency, coagulopathy);
<br>
<br> - Asthenia or splenectomy, functional asthenia caused by any situation;
<br>
<br> - Are receiving anti-TB (tuberculosis) treatment;
<br>
<br> - Have received immune enhancement or inhibitor therapy within 3 months (continuous oral
<br> or instillation for more than 14 days);
<br>
<br> - Have received a live attenuated vaccine within 28 days before vaccination, or received
<br> other vaccines within 14 days before vaccination;
<br>
<br> - Have received blood products within 3 months before vaccination;
<br>
<br> - Have received other study drugs within 6 months before vaccination;
<br>
<br> - Plan to move before the end of the study or leave the local area for a long time
<br> during the scheduled study visit;
<br>
<br> - Other conditions considered by the investigator to be inappropriate for participation
<br> in the study.
<br>
<br> Exclusion criteria for the second and third doses of vaccination
<br>
<br> - Positive urine pregnancy test;
<br>
<br> - Have a high fever (axillary temperature is not less than 39.0?) for three days and
<br> severe allergic reaction after the previous dose of vaccination;
<br>
<br> - Severe adverse reactions that are causally related to the previous dose of
<br> vaccination;
<br>
<br> - For those newly discovered or newly identified after the previous dose of vaccine that
<br> does not meet the first dose selection criteria or meets the first dose exclusion
<br> criteria, the investigator will determine whether to continue participating in the
<br> study;
<br>
<br> - Other exclusion reasons considered by the investigator.
<br> | | COVID-19 | Biological: low-dose Recombinant SARS-CoV-2 Vaccine (CHO cell);Biological: high-dose Recombinant SARS-CoV-2 Vaccine (CHO cell);Biological: placebo | Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody (wild Strains) on the 15th day after the full course of vaccination;the incidence of AESI from the the first dose of vaccination to 12 months after the full course of vaccination;the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination;the incidence and severity of adverse events leading to withdrawal within 60 days after each dose of vaccination;the incidence and severity of adverse events leading to withdrawal within 40 days after each dose of vaccination;the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination;the incidence and severity of non-collective adverse reactions/events within 60 days after each dose of vaccination;the incidence and severity of non-collective adverse reactions/events within 40 days after each dose of vaccination;the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination;the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination;the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination;Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody(wild Strains) on the 15th day after the full course of vaccination;the incidence of AESI from the first dose of vaccination to 12 months after the full course of vaccination;the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination;the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination;the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination;the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination;the incidence of abnormal blood biochemistry, blood routine, blood coagulation function and urine routine on the 4th day after each dose of vaccination;the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination→the incidence of abnormal blood biochemistry, blood routine, blood coagulation function and urine routine on the 4th day after each dose of vaccination;Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody (wild Strains) on the 15th day after the full course of vaccination;the incidence of AESI from the the first dose of vaccination to 12 months after the full course of vaccination;the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination;the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination;the incidence and severity of adverse events leading to withdrawal within 60 days after each dose of vaccination;the incidence and severity of adverse events leading to withdrawal within 40 days after each dose of vaccination;the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination;the incidence and severity of non-collective adverse reactions/events within 60 days after each dose of vaccination;the incidence and severity of non-collective adverse reactions/events within 40 days after each dose of vaccination;the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination;the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination;the incidence and severity of any adverse reactions/events within 30 minutes after each dose of vaccination;Geometric mean Titer of SARS-CoV-2 specific neutralizing antibody(wild Strains) on the 15th day after the full course of vaccination;the incidence of AESI from the first dose of vaccination to 12 months after the full course of vaccination;the incidence of SAE from the first dose of vaccination to 12 months after the full course of vaccination;the incidence and severity of adverse events leading to withdrawal within 30 days after each dose of vaccination;the incidence and severity of non-collective adverse reactions/events within 30 days after each dose of vaccination;the incidence and severity of adverse reactions/events within 0-7 days after each dose of vaccination | | | | Yes | False | | |
| NCT04871672 | 17 May 2021 | Effects of Pilates Exercises on Core Stability After Recovery From COVID -19 | Effects of Pilates Exercises on Core Stability After Recovery From COVID -19 | | University of Jazan | 24/04/2021 | 20210424 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04871672 | Not recruiting | No | 19 Years | 26 Years | Female | May 23, 2021 | 30 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Persons who had mild to moderate covid- 19 illness.
<br>
<br> 2. Asymptomatic period of at least seven days (without chest pain, breathlessness).
<br>
<br> 3. No musculoskeletal damage.
<br>
<br> 4. No pregnancy.
<br>
<br> 5. No visually identified asymmetries in the spinal trunk and lower limbs.
<br>
<br> 6. None of the subjects has a history of balance training
<br>
<br> 7. Subjects will not have any diseases of the central nervous system.
<br>
<br> 8. Subjects with body mass index (BMI)<25 kg/m2.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Persons who had more severe covid 19 illnesses and were hospitalized.
<br>
<br> 2. Persons who had during their illness chest pain breathlessness, palpitation, symptoms,
<br> and signs of heart failure.
<br>
<br> 9. Subjects with cardiopulmonary disorders. 3. A history of previous back or abdominal
<br> surgery/injury 4. Evidence of a systemic or musculoskeletal disease within the past six
<br> months
<br>
<br> -
<br> | | Covid19;Pilates, Core Stability | Other: Pilates Exercises;Other: Home Exercise program | Evaluation of core stability: Endurance capacity of lateral core muscles particularly the quadrates lumborum;Evaluation of core stability: Prone Plank test;Evaluation of core stability: assesses the functioning of trunk extensor muscles;Evaluation of core stability: endurance capacity of anterior deep trunk muscles | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04874818 | 17 May 2021 | CD8+ T-cell PET/CT Imaging in COVID-19 Patients | [89Zr]Df-IAB22M2C Anti-CD8 Minibody PET/CT Imaging to Assess the in Vivo Distribution of CD8+ T-cells in COVID-19 Patients | Tangelo | Radboud University | 28/04/2021 | 20210428 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04874818 | Not recruiting | No | 50 Years | N/A | All | May 2021 | 20 | Observational | | | | | Erik Aarntzen, PhD, MD | | erik.aarntzen@radboudumc.nl | +31(0)243614840 | |
<br> Inclusion Criteria:
<br>
<br> - a microbiologically proven SARS-CoV2 infection
<br>
<br> - More than 50 years of age;
<br>
<br> - Ability to provide written informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Contra-indication for PET: Pregnancy, Breast-feeding, Severe claustrophobia.
<br>
<br> - Contra-indication for administration of iodine-containing contrast agents
<br>
<br> - Other serious illness, e.g. history of malignancies or auto-immune disorders
<br>
<br> - Known pre-existing lymphopenia from an unrelated other medical condition
<br>
<br> - Estimated creatinine clearance = 30 mL/min according to the Cockcroft-Gault formula
<br> (or local institutional standard method) OR oligo-uric patients (<400 mL/24hr)
<br> | | Lymphopenia Due to COVID-19;T-cell;PET Imaging | Diagnostic Test: [89Zr]Df-IAB22M2C PET/CT scan | The primary objective of this study is to assess differences in the in vivo distribution of CD8+ T-cells in patients with proven SARS-CoV-2 presenting with lymphopenia or with normal lymphocyte counts. | | | | Yes | False | | |
| → | NCT04876417 | 17 May 2021 | tDCS for Post COVID-19 Fatigue | Transcranial Direct Current Stimulation (tDCS) for the Treatment of Fatigue in Post-COVID-19 Patients | | Thorsten Rudroff | 15/03/2021 | 20210315 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04876417 | Recruiting | No | 18 Years | 80 Years | All | February 1, 2021 | 50 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | N/A | United States | ; | Thorsten Rudroff, PHD;Thorsten Rudroff, PhD | | thorsten-rudroff@uiowa.edu; | 3194670363; | |
<br> Only those that are discharged from the UIHC COVID-19 inpatient clinic and/or that meet the
<br> CDC guidelines for discontinuing home isolation (i.e., fever free for at least 24 hours,
<br> all symptoms improved after 10 days) will initially be considered as long as they meet the
<br> rest of the following criteria:
<br>
<br> Inclusion criteria
<br>
<br> 1. 18-80 yrs.
<br>
<br> 2. Meet CDC guidelines
<br> (https://www.cdc.gov/coronavirus/2019-ncov/hcp/duration-isolation.html) for
<br> discontinuation of home isolation
<br>
<br> 3. Meet the criteria for fatigue, based on the Chalder Fatigue Scale CFQ-11 case
<br> definition of fatigue
<br>
<br> 4. Healthy enough to complete the protocol based, on information obtained from a clinical
<br> exam and past medical history, such as cardiovascular disease.
<br>
<br> 5. Comprehension of the protocol, as indicated by an ability to respond to questions
<br> about the study after reading the consent form.
<br>
<br> 6. Able to use and be contacted by telephone
<br>
<br> 7. Able to speak, read, and understand English, and complete questionnaires in English
<br>
<br> Exclusion criteria
<br>
<br> 1. Medical diagnosis or condition that is considered to be an absolute or relative
<br> contraindication to participating in exercise training, such as major renal,
<br> pulmonary, hepatic, cardiac, gastrointestinal, HIV, cancer (other than treated basal
<br> cell cancer), or neurological disorders
<br>
<br> 2. History/presence of secondary conditions such as seizure disorders (or on medications
<br> known to lower seizure threshold), hydrocephalus, diabetes mellitus, or claustrophobia
<br>
<br> 3. Alcohol dependence or abuse (>2 drinks/day), or present history of drug abuse (last
<br> six months)
<br>
<br> 4. History of significant traumatic brain injury or hydrocephalus
<br>
<br> 5. Pregnancy
<br> | | Post Covid-19 Patients | Device: Transcranial Direct Current Stimulation;Device: Transcranial Direct Current Stimulation | 6-minute walk test;Fatigue testing of the knee muscles of both legs;Fatigue Severity Scale (FSS);Fatigue Assessment Scale (FAS)→Fatigue Assessment Scale (FAS);Fatigue Severity Scale (FSS);Fatigue testing of the knee muscles of both legs;6-minute walk test | | | | Yes | False | | |
| NCT04876443 | 17 May 2021 | Impact of COVID-19 Outbreak on the Alcohol Consumption in Patients With Alcohol-related Liver Disease (ICoLD) | Impact of COVID-19 Outbreak on the Alcohol Consumption in Patients With Alcohol-related Liver Disease | | King's College Hospital NHS Trust | 05/05/2021 | 20210505 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04876443 | Recruiting | No | 18 Years | N/A | All | October 8, 2020 | 200 | Observational | | | United Kingdom | ; | Naina Shah, MBBS, MRCP (GIM), MRCP;Naina Shah, MBBS, MRCP (GIM), MRCP | | naina.shah1@nhs.net;naina.shah1@nhs.net | 02032999000;02032999000 | |
<br> Inclusion Criteria:
<br>
<br> - Age >18 years.
<br>
<br> - People with alcohol related Liver disease
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient lacks capacity to consent to the study, e.g. due to hepatic encephalopathy,
<br> alcohol-related brain damage, or pre-existing learning disability
<br>
<br> - Aged <18 years old
<br>
<br> - Patients unable to understand English
<br>
<br> - Patients being considered for liver transplant
<br> | | Alcohol-related Liver Disease;Alcohol Dependence;Alcohol Withdrawal;Addiction, Alcohol | Diagnostic Test: Study questionnaire | Episodes of Hepatic decompensation | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2021-001031-72-DK | 17 May 2021 | Metabolic MRI of patients with long-term symptoms after COVID19-infection | Metabolic MRI with hyperpolarized pyruvate in long-term COVID19 patients | | Aarhus University, The MR Research Center | 04/03/2021 | 20210304 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-001031-72 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 08/04/2021 | 10 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Denmark | The MR Research Center | | Palle Juul-Jensens Boulevard 99 | cl@clin.au.dk | | Aarhus University | Inclusion criteria: <br>• Aged 18 – 85 years.<br>• Previous COVID-19 confirmed with PCR or antibody test. <br>• Persistent, post COVID-19 symptoms<br>o From the brain (fatigue, headache, sensory disturbances or cognitive difficulties) OR<br>o From the heart (chest pain, dyspnea or tachycardia)<br>o Symptoms not explained by other diseases after the extensive work-up at long-term COVID19 clinic. <br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 8<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 2<br> | Exclusion criteria: <br>• Contraindications for MRI with contrast:<br>- Chronic kidney disease (eGFR = 30 mL/min/1.73m2)<br>- Heart failure with reduced ejection fraction<br>- Significant obstructive lung disease or severe asthma<br>- Pacemaker, neurostimulator or cholera implant<br>- Metal foreign bodies such as fragments and irremovable piercings<br>- Unsafe medical implants (safety of heart valves, hips and the like must be confirmed)<br>- Intracranial clips or coils <br>- Cardiac pacemakers<br>- Claustrophobia <br>- Largest circumference including arms > 160 cm<br>• Competing neurological, psychiatric, cardiac, liver or systemic diseases including diabetes (except prior TIA, unspecific brain MRI findings, hypertension, atherosclerosis and hyperlipidemia/cholesterolemia which are allowed)<br>• Allergy to pyruvate<br> | Long-term COVID19 symptoms <br>MedDRA version: 23.0
Level: LLT
Classification code 10084382
Term: Coronavirus disease 2019
System Organ Class: 100000004862
;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Investigative Techniques [E05] | <br>Product Name: Hyperpolarized [1-13C]pyruvate<br>Pharmaceutical Form: Concentrate and solvent for solution for infusion<br>INN or Proposed INN: SODIUM PYRUVATE<br>Other descriptive name: SODIUM PYRUVATE<br>Concentration unit: mmol/l millimole(s)/litre<br>Concentration type: equal<br>Concentration number: 250-<br><br> | Timepoint(s) of evaluation of this end point: After the scan. ;Primary end point(s): Brain or heart metabolism as assessed with 13C label exchange from hyperpolarized pyruvate to bicarbonate and lactate.;Secondary Objective: Not applicable;Main Objective: This project seeks to probe the potential of using hyperpolarized pyruvate MRI for detecting metabolic changes in the heart or brain of patients with long-term COVID19 symptoms. | | | | Yes | False | | |
| → | EUCTR2021-002014-14-CZ | 17 May 2021 | Monitoring of antibody response 28 days after the first dose of COVID19 vaccine in clinically stable subjects with functional kidney transplantation. | Antibody and cellular response 28 days after the first dose of COVID-19 vaccine (Moderna) in clinically stable patients with functional kidney transplantation. | | Fakultní nemocnice Hradec Králové | 16/04/2021 | 20210416 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-002014-14 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 20/04/2021 | 60 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Czech Republic | Oddelení klinických hodnocení | | Sokolská 581 | karolina.mullerova@fnhk.cz | 00420727833725 | Fakultní nemocnice Hradec Králové | Inclusion criteria: <br>1. age 20 = 75 years<br>2. the ability to understand the nature and course of the study and to agree in writing to the study by signing Informed Consent<br>3. Day 28 after dosing Moderna<br>4. with a functional kidney transplant<br>5. with stable function of the transplanted kidney (graft)<br>6. 3 months after kidney transplantation<br>7. no change in immunosuppressive therapy and / or no infection since the Moderna dose was given<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 30<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 30<br> | Exclusion criteria: <br>1. insufficient venous system in the upper limbs with the risk of having repeated intravenous injections to obtain a blood sample<br>2. past COVID-19 disease<br>3. concurrent participation in another clinical trial<br>4. pregnancy, breastfeeding<br> | Antibody and cellular response 28 days after the first dose of COVID-19 vaccine (Moderna) in clinically stable patients with functional kidney transplantation.;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Pharmaceutical Form: <br><br>Pharmaceutical Form: <br><br> | Secondary Objective: At the same time interval, ie 28 days after the first dose of Moderna, characterize the basic cellular immune response and evaluate the results in relation to the measured antibody values and to other routinely monitored clinical data (available from routine regular medical examinations).;Timepoint(s) of evaluation of this end point: After all blood samples collections.;Primary end point(s): Describe the antibody response in clinically stable patients after successful kidney transplantation 28 days after the first dose of a registered mRNA-vaccine against COVID-19 disease (Moderna vaccine).;Main Objective: Describe the antibody response in clinically stable patients after successful kidney transplantation 28 days after the first dose of a registered mRNA-vaccine against COVID-19 disease (Moderna vaccine).→Secondary Objective: At the same time interval, ie 28 days after the first dose of Moderna, characterize the basic cellular immune response and evaluate the results in relation to the measured antibody values and to other routinely monitored clinical data (available from routine regular medical examinations).;Primary end point(s): Describe the antibody response in clinically stable patients after successful kidney transplantation 28 days after the first dose of a registered mRNA-vaccine against COVID-19 disease (Moderna vaccine).;Timepoint(s) of evaluation of this end point: After all blood samples collections.;Main Objective: Describe the antibody response in clinically stable patients after successful kidney transplantation 28 days after the first dose of a registered mRNA-vaccine against COVID-19 disease (Moderna vaccine). | | | | Yes | False | | |
| EUCTR2020-001302-30-AT | 17 May 2021 | A multicenter, randomized, active controlled, open label, platform trial on the efficacy and safety of experimental therapeutics for patients with a lung disease caused by coronavirus infection
ACOVACT (Austrian CoronaVirus Adaptive Clinical Trial) | A multicenter, randomized, active controlled, open label, platform trial on the efficacy and safety of experimental therapeutics for patients with COVID-19 (caused by infection with severe acute respiratory syndrome coronavirus-2)
ACOVACT (Austrian CoronaVirus Adaptive Clinical Trial) | | Medical University of Vienna | 09/04/2020 | 20200409 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001302-30 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 15/04/2020 | 500 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 4<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Austria | Sponsor | | Währinger Gürtel 18-20 | klin-pharmakologie@meduniwien.ac.at | | Medical University of Vienna, Department of Clinical Pharmacology | Inclusion criteria: <br>• Laboratory confirmed (i.e. PCR-based assay) infection with SARS-CoV-2 (ideally but not necessarily =72 hours before randomization for “antiviral” treatments) OR radiological signs of COVID-19 in chest X-ray or computed tomography*<br>• Hospitalisation due to SARS-CoV-2 infection (for anti-viral treatment arms)<br>• Requirement of oxygen support (due to oxygen saturation <94% on ambient air or >3% drop in case of chronic obstructive lung disease) <br>• Informed Consent obtained, the patient understands and agrees to comply with the planned study procedures, except for sub-study C: obtaining informed consent may be impossible due to the severe condition of the patient and may be waived<br>• =18 years of age<br>• For female patients with childbearing potential: willingness to perform effective measures of contraception during the study. <br>• For treatment arm 4 (Convalescent plasma) only immunocompromised patients (e.g. after having received chemotherapy, with inherited or acquired immunodeficiency syndromes) are eligible<br>• Sub-study A: eGFR of >20 mL/min<br>• Sub-study B: outpatients with COVID-19 may be included<br>• Sub-study B: blood pressure =130/85mmHg in 2 consecutive measurements OR patients with established and treated hypertension<br>• Sub-study B: Control group 1: Patients with suspicion of but negative tests for COVID-19. This group may consist of hospitalized and non-hospitalized patients.<br>• Sub-study B: control group 2: healthy volunteers<br>• Sub-study C: Signs of respiratory deterioration and progressing inflammation: need for oxygen supplementation, non-invasive ventilation, high-flow oxygen devices or mechanical ventilation AND CRP levels >5mg/dL (for Pentaglobin only), and admission to an ICU (for Pentaglobin only). <br>• Qualitative Study: all participants who are fluent in German or English will be asked about participation in this study part – which is however, optional<br>If for any given reason a patient does not qualify to participate in the main study, this will not preclude participation in sub-study C. <br>*In case of negative PCR but clear radiological signs of COVID-19 patients have to be retested with serial nasopharyngeal swabs and PCR and, if possible antibody based assays. In any case, a laboratory based proof of COVID-19 is required or else the subject may be excluded from the per protocol analysis.<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 250<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 250<br> | Exclusion criteria: <br>• Moribund or estimated life expectancy <1 month (e.g. terminal cancer, etc.) <br>• Patient does not qualify for intensive care, based on local triage criteria<br>• Pregnancy or breastfeeding<br>• Severe liver dysfunction (e.g. ALT/AST > 5 times upper limit of normal)<br>• Stage 4 chronic kidney disease or requiring dialysis for direct anticoagulant treatment<br>• Allergy or intolerances to any of the experimental substances -> exclusion for the respective treatment arm; for asunercept known hereditary fructose intolerance<br>• Anticipated discharge of hospital within 48 hours (for anti-viral treatment arms)<br>• Contraindications treatment arm 2 (lopinavir/ritonavir): severe hepatic impairment, CYP3A4/5 metabolized drugs as deemed relevant by treating physicians, HIV positive<br>• Contraindication treatment arm 3 (remdesivir): Bodyweight <40kg, <br>• Contraindications treatment arm 5 (convalescent plasma): IgA deficiency<br>• Sub-study A Contraindications: active bleeding or bleeding diathesis, lesion or condition considered as major risk factor for bleeding, recent brain or spinal injury, recent brain or spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms, major intraspinal or intracerebral vascular abnormalities.<br>• Sub-study A: ongoing therapeutic anticoagulation, which will continue, according to clinical practice <br>• Sub-study B Contraindications chronic heart failure, allergies, hypersensitivities and intolerances, severe hepatic impairment and/or cholestasis, concomitant therapy with aliskiren-containing medications (for patients with diabetes mellitus or a GFR<60ml/min/1.73m2), known significant bilateral renal artery stenosis or renal artery stenosis of a solitary kidney<br>• Sub-study B: Control group 1: with or without RAS blockers, Control group 2: Healthy volunteers: concomitant medication with RAS-blockers<br>• Sub-study C: known active HIV or viral hepatitis<br>• Asunercept: females of childbearing potential <br>• Sub-Study C: Known active tuberculosis. <br><br> | Infection with SARS-COV-2 (=COVID-19) <br>MedDRA version: 21.1
Level: PT
Classification code 10035737
Term: Pneumonia viral
System Organ Class: 10021881 - Infections and infestations
<br>MedDRA version: 21.1
Level: LLT
Classification code 10003083
Term: ARDS
System Organ Class: 100000004855
<br>MedDRA version: 20.0
Level: LLT
Classification code 10038700
Term: Respiratory infection
System Organ Class: 10021881 - Infections and infestations
<br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Trade Name: Kaletra<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: LOPINAVIR<br>CAS Number: 192725-17-0<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br>INN or Proposed INN: RITONAVIR<br>CAS Number: 155213-67-5<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 50-<br><br>Trade Name: Xarelto<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: RIVAROXABAN<br>CAS Number: 366789-02-8<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 10-<br><br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Candesartan<br>Other descriptive name: CANDESARTAN CILEXETIL<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 4-<br><br>Product Name: Asunercept<br>Product Code: APG101<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: ASUNERCEPT<br>Current Sponsor code: APG101<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 20-<br><br>Trade Name: Veklury<br>Pharmaceutical Form: Solution for infusion<br>INN or Proposed INN: REMDESIVIR<br>Other descriptive name: REMDESIVIR<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 5-<br><br>Trade Name: Pentaglobin<br>Product Name: Pentaglobin<br>Pharmaceutical Form: Solution for infusion<br>INN or Proposed INN: Immunglobulin<br>Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 50-<br><br> | Timepoint(s) of evaluation of this end point: measured daily until day 29 ;Primary end point(s): Time to sustained improvement of one category from admission in the 7-point clinical performance scale;Secondary Objective: • Time to discharge or to a NEWS of =2 and maintained for 24 hours, whichever occurs first<br>• Change from baseline<br>• Oxygenation free days until day 29<br>• Incidence and duration of new oxygen use during trial <br>• Ventilator free days until day 29<br>• Incidence and duration of new mechanical ventilation use<br>• Viral load/viral clearance change at baseline and 3x/w<br>? Duration of hospitalization, ICU treatments & admissions<br>• 15-, 29- & 60-day mortality<br>• Qualitative Study: semi-structured interviews<br>• Renin-Angiotensin System (RAS)-fingerprint at baseline and at least once weekly<br>• Within all patients, the impact of obesity and associated disesaes on mortality will be investigated<br>• Cumulative incidence of serious adverse events<br>• iscontinuation or temporary suspension of therapy<br>• Changes in WBC,hemoglobin,platelets,creatinine,glucose,total bilirubin,ALT,AST<br>• Within all patients, the impact of obesity and associated diseases on mortality;Main Objective: To investigate the efficacy of various experimental therapeutics for patients with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2); for efficacy assessment an ordinal scale for clinical severity assessment as proposed by the World Health Organization will be used:<br><br>• Time to sustained improvement of one category from admission | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| ChiCTR2000038160 | 24 May 2021 | The efficacy and safety of ambroxol hydrochloride in the treatment of novel coronavirus pneumonia (COVID-19): a retrospective medical based study | The efficacy and safety of ambroxol hydrochloride in the treatment of novel coronavirus pneumonia (COVID-19): a retrospective study | | Zhongnan Hospital of Wuhan University | 2020-09-11 | 20200911 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=61045 | Recruiting | No | 18 | | Both | 2020-09-11 | 1:600;2:600; | Observational study | Factorial | Retrospective study | China | Hong Cheng | | 169 Donghu Road, Wuchang District, Wuhan, Hubei, China | chenghong@znhospital.cn | +86 13387660579 | Zhongnan Hospital of Wuhan University | Inclusion criteria: 1. patients with novel coronavirus infection have been diagnosed;
<br>2. aged >=18 years. | Exclusion criteria: (1) cases who had been transfered to other hospitals for further treatment;
<br>(2) Cases whose data are incomplete and cannot be accurately dialectical. | novel coronavirus pneumonia (COVID-19) | 1:ambroxol hydrochloride treatment;2:without ambroxol hydrochloride treatment; | the number of patients with aggravation of disease; | | | | Yes | False | | |
| → | CTRI/2021/03/032202 | 24 May 2021 | Quality of life and mental health of people who have recovered after COVID 19 infection: A survey | Exposure to COVID-19 and influence on quality of life and mental
health among COVID-19 survivorâ??s: A survey | | Dr Vaishali K | 22-03-2021 | 20210322 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53825 | Not Recruiting | No | | | | 22-03-2021 | 384 | Observational | Other
Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:→Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Vaishali K→ | | Department of Physiotherapy
Manipal College of Health Professions
Madhav Nagar Manipal College of Health Professions→ | vaishali.kh@manipal.edu→ | 918296011839→ | Manipal Academy of Higher Education→ | Inclusion criteria: : COVID 19 survivors within 6 months of COVID-19 infection, those able to communicate via a telephone→ | Exclusion criteria: impaired mobility due to musculoskeletal and neurological impairments <br/ ><br>before the pandemic (information would be retrieved from medical records and telephone <br/ ><br>calls), those unable to comprehend English, unwilling to participate in the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | EQ 5D, DASS 21, mMRC, FACIT-F, IADL, PCFS scaleTimepoint: At baseline and after 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/03/032199 | 24 May 2021 | Pirfenidone for COVID-19 related lung fibrosis | Pirfenidone for coronavirus disease 2019 (COVID-19) related pulmonary fibrosis: A placebo-controlled randomized controlled trial | | Anant Mohan | 22-03-2021 | 20210322 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49593 | Not Recruiting | No | | | | 31-03-2021 | 60 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 3 | India→ | Anant Mohan→ | | Dept of Pulmonary, Critical Care and sleep medicine, Room no. 9, Porta Cabin, Third floor, New pvt ward, AIIMS, Ansari Nagar, Delhi-110029 → | anantmohan@yahoo.com→ | | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: 1. History of COVID-19 illness diagnosed by RT-PCR/Rapid antigen/ Truenaat of throat or nasopharyngeal swab at least 8 weeks prior <br/ ><br>2. Having persistent respiratory symptoms (cough and breathlessness) or persistent hypoxemia (SpO2 <94% on room air) or oxygen desaturation on exercise <br/ ><br>AND <br/ ><br>Has evidence of pulmonary fibrosis on HRCT thorax (at least 15% involvement by visual semi-quantitative assessment) performed at least 8 weeks after COVID-19 diagnosis <br/ ><br>3. Provides written informed consent for evaluation and treatment as per study protocol <br/ ><br>→ | Exclusion criteria: 1. Patients not providing consent for participation in the study <br/ ><br>2. FEV1/FVC ratio < 0.80 <br/ ><br>3. Active smokers <br/ ><br>4. Any active malignancy/ malignancy within past 2 years <br/ ><br>5. Severe hepatic impairment <br/ ><br>6. Use of immunosuppressant drugs (except corticosteroids and tocilizumab) within last 6 weeks <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Pirfenidone tablet 800 mg three times a day: For 6 months<br>Control Intervention1: Matched Placebo 800 mg for three times per day: For 6 months<br>→ | The change in Forced Vital Capacity (FVC) (% predicted) at 6 months following treatment initiation with oral Pirfenidone versus placebo in patients with COVID-19 associated pulmonary fibrosisTimepoint: at 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/03/032226 | 24 May 2021 | Body Mass Index relation with COVID 19 patients | Correlation between BMI and outcome of COVID19 pneumonia patients: a retrospective observational study | | Government institute of medical sciences Greater Noida | 23-03-2021 | 20210323 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54283 | Not Recruiting | No | | | | 30-03-2021 | 433 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Savita Gupta→ | | Department of Anaesthesia
Government Institute of Medical Sciences Kasna Greater Noida 201310
Kasna Greater Noida 201310→ | dr.gsavita@gmail.com→ | 8750657382→ | Government Institute of Medical Sciences→ | Inclusion criteria: The inclusion criteria were 18 Years and older adult patients with a confirmed diagnosis of COVID-19 by rt PCR assay and inpatient admission.→ | Exclusion criteria: The main exclusion criteria were age under 18 or no weight or height measurement available in the medical files.→ | Health Condition 1: O- Medical and Surgical
→ | | The primary outcome - death within 14 days of ICU admission. Patients who are discharged alive from the hospital before 14 days are considered to be alive at 14 daysTimepoint: The primary outcome - death within 14 days of ICU admission. Patients who are discharged alive from the hospital before 14 days are considered to be alive at 14 days→ | | | | Yes | False | | |
| → | CTRI/2021/03/032225 | 24 May 2021 | Homoeopathic treatment of respiratory sequelae of post- covid cases: an open label prospective study | Homoeopathic treatment of respiratory sequelae of post- covid cases: an open label prospective interventional pilot study | | Dr Anil Khurana | 23-03-2021 | 20210323 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50734 | Not Recruiting | No | | | | 30-03-2021 | 50 | Interventional | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Anant Mohan→ | | Department of PCCSM, Room no.9, Porta Cabin, Third floor, New Private Ward, AIIMS → | anantmohan@yahoo.com→ | | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: 1. Age 18-80 years <br/ ><br>2. Previously positive COVID cases (ICD code: U07.1) <br/ ><br>3. Patient who tested to be COVID-19 negative, 4 weeks after discharge from COVID Care Centre. <br/ ><br>4. Patient presenting with any of the respiratory symptoms such as - shortness of breath, cough, expectoration, chest pain and other respiratory complaints (ICD code: B97.29) <br/ ><br>5. HRCT confirmed cases of COVID Lung Damage like ground glass opacities and fibrosis <br/ ><br>6. PFT with features of restriction evidenced by FVC < 80% and FeV1 < 80% of the predicted value ( ATS-ERS recommendation/ guideline) <br/ ><br>7. Willing to give consent in writing <br/ ><br>→ | Exclusion criteria: 1. Patients who are tested to be COVID-19 positive, at the time of enrollment in the study. <br/ ><br>2. Patient with previous history of COPD, Asthma, Bronchiectesis and Chronic Cardiac ailments <br/ ><br>3. Pregnant and lactating women <br/ ><br>4. Patients who are not willing to volunteer for the study. <br/ ><br>5. Patients developing serious complications, Immuno-compromisedpatients <br/ ><br>6. Idiosyncratic reactions, severe medicinal aggravation and requiring ventilator support or emergency surgical intervention. <br/ ><br>→ | | Intervention1: Homoeopathic medications based upon symptom analysis (Dose and timing will vary from patient to patient): Homoeopathic medications based upon symptom analysis (Dose and timing will vary from patient to patient) will be given for 3 months<br>Control Intervention1: Not applicable: Not applicable<br>→ | To study the role of homoeopathic treatment in Respiratory sequelae of Post COVID cases.Timepoint: at 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/03/032204 | 24 May 2021 | Association of chest x ray findings with clinical severity of covid 19 patients admittedto hospital | Chest x ray findings with clinical severity in hospitalised covid19 patients | | Nandakrishna B | 23-03-2021 | 20210323 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53623 | Not Recruiting | No | | | | 25-03-2021 | 500 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Nandakrishna B→ | | Department of Medicine
Kasturba Medical College
Manipal
Udupi Manipal→ | nandaksb@gmail.com→ | 9914201838→ | Kasturba Medical College→ | Inclusion criteria: Diagnosed with covid 19 and hospitalized→ | Exclusion criteria: Pregnancy <br/ ><br>interstitial lung disease <br/ ><br>bronchiectasis→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To compare clinical severity with chest x ray scoringTimepoint: One time at admission/baseline only→ | | | | Yes | False | | |
| → | CTRI/2021/03/032223 | 24 May 2021 | SOCIAL AND PYSCHOLOGICAL CHANGES IN POSTPARTUM WOMEN DURING COVID-19 PANDEMIC | MENTAL HEALTH OF POSTPARTUM WOMEN DURING COVID-19 PANDEMIC | | DR S R Mudanur | 23-03-2021 | 20210323 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52880 | Not Recruiting | No | | | | 31-03-2021 | 100 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr K Latha Varma→ | | SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND
RESEARCH CENTRE VIJAYAPURA KARNATAKA
SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND
RESEARCH CENTRE VIJAYAPURA KARNATAKA
→ | drmudanurs@gmail.com→ | 8106725928→ | BLDE DEEMED TO BE UNIVERSITY SHRI B M PATIL MEDICAL COLLEGE AND RESEARCH HOSPITAL→ | Inclusion criteria: all postpartum women who have delivered within 7 days postpartum→ | Exclusion criteria: women with known pyschiatric conditions <br/ ><br>women who delivered postpartum psychosis <br/ ><br>women enable to respond due to any acute medical conditions→ | Health Condition 1: O268- Other specified pregnancy relatedconditions
→ | Control Intervention1: nil: nil<br>→ | to study the mental health of post partum women during covid-19 pandemicTimepoint: ON IMMEDIATE POSTPARTUM DAY AND AGAIN AFTER 2 WEEKS POSTPARTUM→ | | | | Yes | False | | |
| → | CTRI/2021/03/032224 | 24 May 2021 | Televisits with in- person visits during pregnancy during COVID-19 pandemic and its revival phase - how will that affect your pregnancy | Impact of telemedicine on obstetric outcome and level of patient satisfaction COVID-19 pandemic and its revival | | PGIMER Chandigarh | 23-03-2021 | 20210323 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50863 | Not Recruiting | No | | | | 28-03-2021 | 200 | Observational | Other
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label→Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Shalini Lohan→ | | Department of Obstetrics and Gynaecology
Post Graduate Institute of medical education and research PGIMER Chandigarh → | minurohilla@yahoo.com→ | 9914209354→ | PGIMER Chandigarh→ | Inclusion criteria: low risk pregnant woman till 20 weeks of pregnancy, educated upto minimum 10th class→ | Exclusion criteria: high risk pregnancy→ | | | maternal outcome and neonatal outcomeTimepoint: maternal and neonatal outcome at the time of delivery and post partum period→ | | | | Yes | False | | |
| → | CTRI/2021/03/032227 | 24 May 2021 | KAP study on COVID 19 | Knowledge, Attitude, Practice of biomedical waste management
during COVID 19 pandemic: A single centered study - KAP COVID | | Dr Meenu Self | 23-03-2021 | 20210323 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54263 | Not Recruiting | No | | | | 30-03-2021 | 200 | Observational | Other
Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant Blinded→Other<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant Blinded | N/A | India→ | Dr Meenu PS→ | | Department of hospital administration
PSPH
MAHE Manipal → | somu.g@manipal.edu→ | 9448463186→ | PSPH→ | Inclusion criteria: Healthcare workers→ | Exclusion criteria: Not willing to participate→ | | | to understand the awareness on COVID protocols by healthcare personnel so that training can be initiatedTimepoint: 2-3 MONTHS→ | | | | Yes | False | | |
| → | CTRI/2021/03/032279 | 24 May 2021 | Impact of COVID 19 pandemic on Ayurveda students | Impact of COVID 19 pandemic on Undergraduate Ayurveda studentsâ?? education- A cross-sectional survey - ICPAS | | nil | 24-03-2021 | 20210324 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54146 | Not Recruiting | No | | | | 30-03-2021 | 300 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Reena Kulkarni→ | | Department of Kaumarabhritya
SDM Institute of Ayurveda and Hospital Anchepalya
Bengaluru
75 Vadiraja 6th cross 1st stage BEML Layout Basaveshwaraya nagara 5600709→ | drreenakulkarni@gmail.com→ | 9480478639→ | SDM Institute of Ayurveda and Hospital, Anchepalya, Bengaluru→ | Inclusion criteria: Ayurvedic undergraduates students→ | Exclusion criteria: Nil→ | | Intervention1: NIL: NIL<br>→ | Impact of COVID 19 pandemic on Ayurveda academicsTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/03/032276 | 24 May 2021 | Comorbidities in death due to COVID 19 infection | Evaluation of comorbidities associated in patients who died due to COVID 19 infection in a tertiary care centre in Dakshina Kannada | | Yenepoya Medical College Hospital | 24-03-2021 | 20210324 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53439 | Not Recruiting | No | | | | 01-04-2021 | 125 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Karumuri Subba Rithwik→ | | University Road, Deralakatte, Mangaluru,575018 University Road, Deralakatte, Mangaluru,575018→ | karumuri.rithwik@gmail.com→ | 9440613442→ | Yenepoya Medical College→ | Inclusion criteria: COVID-19 positive patients who died in Yenepoya Medical College Hospital→ | Exclusion criteria: COVID-19 positive patients who died but age less than 18 years→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Comorbidities for death in COVID-19Timepoint: 1 March 2020 to 31 January 2021→ | | | | Yes | False | | |
| → | CTRI/2021/03/032293 | 24 May 2021 | Associated lung condition in viral infection | Randomised, Embedded, Multifactorial, Adaptive, Platform Trial for Community-Acquired Pneumonia (REMAP-CAP) â?? Therapeutic anticoagulation in COVID-19 - REMAP-CAP | | Monash University | 25-03-2021 | 20210325 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45649 | Not Recruiting | No | | | | 20-04-2021 | 200 | Interventional | Randomized Factorial Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label→Randomized Factorial Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3 | India→ | Dr Devachandran Jayakumar→ | | Critical Care Unit
Vanagaram, Chennai → | deva@icuconsultants.com→ | | Apollo Speciality Hospitals→ | Inclusion criteria: 1. Adult patient admitted to an ICU for acute severe CAP within 48 hours of hospital admission with <br/ ><br> a. symptoms or signs or both that are <br/ ><br> consistent with lower respiratory tract <br/ ><br> infection (for example, acute onset of <br/ ><br> dyspnea, cough, pleuritic chest pain) AND <br/ ><br> b. Radiological evidence of new onset <br/ ><br> infiltrate of infective origin (in patients <br/ ><br> with preexisting radiological changes, <br/ ><br> evidence of new infiltrate) <br/ ><br>2. Up to 48 hours after ICU admission, receiving organ support with one or more of: <br/ ><br> a. Non-invasive or invasive ventilatory <br/ ><br> support <br/ ><br> b. Receiving infusion of vasopressor or <br/ ><br> inotropes or both→ | Exclusion criteria: 1. Healthcare-associated pneumonia: <br/ ><br> a. Prior to this illness, is known to have <br/ ><br> been an inpatient in any healthcare <br/ ><br> facility within the last 30 days <br/ ><br> b. Resident of a nursing home or long-term <br/ ><br> care facility. <br/ ><br>2. Death is deemed to be imminent and inevitable during the next 24 hours AND one or more of the patient, substitute decision maker or attending physician are not committed to full active treatment. <br/ ><br>3. Previous participation in this REMAP within the last 90 days <br/ ><br>4. Clinical or laboratory bleeding risk or both that is sufficient to contraindicate therapeutic anticoagulation, including intention to continue or commence dual anti-platelet therapy <br/ ><br>5. Therapeutic anticoagulation is already present due to prior administration of any anticoagulant agent that is known or likely to still be active or a clinical decision has been made to commence therapeutic anticoagulation <br/ ><br>6. Enrolment in a trial evaluating anticoagulation for proven or suspected COVID19 infection, where the protocol of that trial requires continuation of the treatment assignment specified in that trial <br/ ><br>7. Known or suspected previous adverse reaction to UFH or LMWH including heparin induced thrombocytopenia (HIT).→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J188- Other pneumonia, unspecified organism
→ | Intervention1: Enoxaparin 40mg: Enoxaparin 40mg SC OD or equivalent dose of unfractionated heparin<br>Intervention2: Enoxaparin 1mg/kg: Enoxaparin 1mg/kg SC twice daily or unfractionated heparin infusion to maintain an aPTT 1.5 to 2.5<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | all cause mortality at 90 daysTimepoint: 90 days→ | | | | Yes | False | | |
| → | CTRI/2021/03/032292 | 24 May 2021 | Spectrum of CT findings in chest in COVID 19 infection and their progression. | Spectrum of Computed Tomography findings in chest in COVID-2019 infection and their temporal evolution. | | Max Superspeciality Hospital | 25-03-2021 | 20210325 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51793 | Not Recruiting | No | | | | 26-03-2021 | 264 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Anandamoyee Dhar→ | | Department of radiodiagnosis,ground floor,west block,Max Superspeciality Hospital,1,press enclave road ,saket, New delhi- 110017 → | drsahuamit@gmail.com→ | 8669457675→ | Max superspeciality hospital→ | Inclusion criteria: Patients positive for COVID 19 pneumonia Rapid antigen test and / or RT-PCR test.→ | Exclusion criteria: Patients negative for COVID 19 pneumonia Rapid antigen test and / or RT-PCR test. <br/ ><br>Patients not willing to participate in the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. To determine the spectrum of CT findings in COVID 19 pneumonia on different variables. <br/ ><br>Timepoint: Over the period of 1 year.→ | | | | Yes | False | | |
| → | CTRI/2021/03/032312 | 24 May 2021 | COVID 19 in the critically ill | Clinical profile and outcomes of patients admitted to the medical intensive care unit (MICU) with SARS-CoV-2 infection | | Fluid Research Grant Christian Medical College Vellore | 25-03-2021 | 20210325 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54355 | Not Recruiting | No | | | | 01-04-2021 | 700 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Binila Chacko→ | | Medical Intensive Care Unit,
Christian Medical College, Vellore
Phone: 2693, Mobile: 9600272412;
→ | binilachacko@gmail.com→ | 9600272412→ | Christian Medical College, Vellore→ | Inclusion criteria: All the patients admitted to the MICU who test positive for the COVID- 19 RT-PCR test over the duration of study and meet the inclusion criteria will be enrolled in the study→ | Exclusion criteria: Anyone who does not give consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | Duration of ICU and hospital stay <br/ ><br>Mortality-ICU and hospital <br/ ><br>Nosocomial infection <br/ ><br>Need for ventilation and duration of ventilation <br/ ><br>Need and duration of muscle relaxants <br/ ><br>Tracheostomy <br/ ><br>Need and duration of renal replacement therapy <br/ ><br>Duration of renal replacement therapy <br/ ><br>Organ dysfunction through SOFA (Sequential Organ Failure Assessment) score <br/ ><br>Complications â?? Seizures, myocarditis, bleed, pulmonary embolism <br/ ><br>Timepoint: Baseline <br/ ><br>ICU discharge <br/ ><br>Hospital discharge <br/ ><br>1 month follow up→ | | | | Yes | False | | |
| → | CTRI/2021/03/032357 | 24 May 2021 | Surface sampling for SARS-CoV-2 around hospital patients | Environmental surface sampling for SARS-CoV-2 around hospitalized patients with COVID19 in a tertiary care hospital | | Government Institute of Medical Sciences | 26-03-2021 | 20210326 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54371 | Not Recruiting | No | | | | 02-04-2021 | 355 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Varun Goel→ | | Department of Microbiology
Government Institute of Medical Sciences Kasna Greater Noida 201310
Government Institute of Medical Sciences Kasna Greater Noida 201310→ | drvarun21@gmail.com→ | 9650430879→ | Government Institute of Medical Sciences→ | Inclusion criteria: COVID -19 positive patient wards and ICU <br/ ><br>→ | Exclusion criteria: None <br/ ><br>→ | Health Condition 1: O- Medical and Surgical
→ | | To investigate environmental contamination caused by COVID-19 patients in a variety of hospital settingsTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2021/03/032356 | 24 May 2021 | Follow up of COVID19 patients after discharge from ICU. | Post discharge outcomes of COVID-19 patients following admission to Intensive Care Unit.A prospective Cohort study | | All India Institute of Medical Sciences New Delhi | 26-03-2021 | 20210326 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54399 | Not Recruiting | No | | | | 15-04-2021 | 500 | Observational | Other
Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:→Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Kapil Dev Soni→ | | Room 323, JPN Apex Trauma Center, All India Institute of Medical Sciences, New Delhi → | kdsoni111@gmail.com→ | 9718661658→ | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: All patients above the age of 18, which is the legal age for consent in in India who are admitted <br/ ><br>in Covid ICU of Aiims Covid Center, following positive confirmation test and discharged alive <br/ ><br>will be included in the study.→ | Exclusion criteria: Exclusion -Pregnant patients→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | long-term survival of COVID- <br/ ><br>19 patients post Intensive Care Unit stay. <br/ ><br>Quality of lifeTimepoint: 12 months→ | | | | Yes | False | | |
| → | CTRI/2021/03/032361 | 24 May 2021 | Health careâ??associated infection in intensive care unit in COVID-19 patients | Device-associated health careâ??associated infection in an intensive care unit in COVID-19 patients | | Government Institute of Medical Sciences | 26-03-2021 | 20210326 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54426 | Not Recruiting | No | | | | 05-05-2021 | 100 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Varun Goel→ | | Department of Microbiology
Government Institute of Medical Sciences Kasna Greater Noida 201310 → | drvarun21@gmail.com→ | 9650430879→ | Government Institute of Medical Sciences→ | Inclusion criteria: Patients admitted to the ICU and hospitalized for more than 48 h <br/ ><br>→ | Exclusion criteria: Patients admitted in wards <br/ ><br>→ | Health Condition 1: O- Medical and Surgical
→ | | To identify the rates of device-associated HAIs (Ventilator associated events (VAE), central lineâ??associated bloodstream infection [CLABSI], and catheter-associated urinary tract infection [CAUTI]) and to identify the pathogens associated with these DA-HAIs. <br/ ><br>Timepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2021/03/032325 | 24 May 2021 | Digestive symptoms in patients with severe COVID-19 -study of frequency and effect on illness. | Digestive symptoms in patients with COVID-19 with critical illness:
Incidence, progression and effect on Outcome: A prospective inceptional cohort
study. | | AIIMS Bhopal | 26-03-2021 | 20210326 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53663 | Not Recruiting | No | | | | 01-04-2021 | 200 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Outcome Assessor Blinded→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Sunaina Tejpal Karna→ | | Dept of Anesthesiology, AIIMS Bhopal, Madhya Pradesh, India. Department of Anesthesiology and Critical Care, AIIMS Bhopal, Saket Nagar, Bhopal, India- 462020→ | drtejpal@gmail.com→ | 9540946869→ | AIIMS, Bhopal→ | Inclusion criteria: All patients with cover-19 admitted to our COVID Intensive care ICU will be enrolled prospectively with following inclusion criteria- <br/ ><br>Patients infected with COVID-19 (confirmed) <br/ ><br>Critically ill patients needing ICU care→ | Exclusion criteria: â?¢ Patient less than 18 years of age <br/ ><br>â?¢ Loss on follow up <br/ ><br>→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: Nil: Observational study<br>→ | To find incidence and clinical spectrum of digestive symptoms in patients with Severe and Critical COVID-19 who need intensive care.Timepoint: at Baseline on intensive care admission.→ | | 30/11/2020 | | Yes | False | | |
| → | CTRI/2021/03/032348 | 24 May 2021 | Assessment of Knowledge, Attitude and Practice towards COVID-19 |
Knowledge, Attitude and Practice towards COVID-19 in patients visiting Gastroenterology and Hepatology OPD
| | Shailesh | 26-03-2021 | 20210326 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54210 | Not Recruiting | No | | | | 29-03-2021 | 924 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:On-site computer system Blinding and masking:Participant and Investigator Blinded→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:On-site computer system Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Shailesh→ | | Dept. of Gastroenterology and Hepatology, Kasturba Medical College, Manipal 576104 → | shiran.shetty@manipal.edu→ | 8861920517→ | Kasturba Medical College→ | Inclusion criteria: Aged 18 and above <br/ ><br>Able to read and understand the content of the questionnaire (English or Kannada)→ | Exclusion criteria: Not willing to give the consent / Unwilling to participate in the research. <br/ ><br>Patients who do not read and understand Kannada or English. <br/ ><br>Unable to fill in the questionnaire due to illness or other reasons. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: K20-K31- Diseases of esophagus, stomach and duodenum
Health Condition 3: K70-K77- Diseases of liver
Health Condition 4: K65-K68- Diseases of peritoneum and retroperitoneum
Health Condition 5: K80-K87- Disorders of gallbladder, biliary tract and pancreas
Health Condition 6: K50-K52- Noninfective enteritis and colitis
Health Condition 7: K55-K64- Other diseases of intestines
Health Condition 8: K90-K95- Other diseases of the digestive system
→ | | assess the knowledge about COVID-19 using the self-administered questionnaire (36 questions)Timepoint: Baseline only. No Follow-up→ | | | | Yes | False | | |
| → | CTRI/2021/03/032322 | 24 May 2021 | Kidney involvement in COVID 19 infection | Spectrum of renal involvement in COVID 19 infection - KIDCOV | | CHAGANTI SINDHU | 26-03-2021 | 20210326 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51948 | Not Recruiting | No | | | | 01-04-2021 | 2600 | Observational | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr M JayaKumar→ | | F2 OPD,Udayar block, Sri Ramachandra Institute of Higher education and Research,
Chennai CHENNAI→ | jayakumar.m@sriramachandra.edu.in→ | 9841046401→ | Sri Ramachandra Institute of higher education and research→ | Inclusion criteria: COVID 19 Positive Admitted at Sri Ramachandra Institute of higher education and research between May 2020 TO September 2020 <br/ ><br>Renal involvement in the form of acute kidney injury, urinary abnormalities.→ | Exclusion criteria: AGE LESS THAN 18 YEARS <br/ ><br>COVID 19 NEGATIVE INDIVIDUALS→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | Spectrum of kidney involvement in COVID 19 infectionTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2021/03/032410 | 24 May 2021 | Effect of â??Kriya Yogaâ?? on brain activity and perceived stress in health care providers, during COVID-19 Pandemic | Effect of â??Kriya Yogaâ?? on brain oscillations and perceived stress in health care providers, during COVID-19 Pandemic: A Pilot Study | | Department of Science and Technology | 30-03-2021 | 20210330 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54078 | Not Recruiting | No | | | | 15-05-2021 | 100 | Interventional | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Pooja Ojha→ | | Department of Physiology, All India Institute of Medical Sciences, Jodhpur 342005, Rajasthan → | drpojha@gmail.com→ | | All India Institute of Medical Sciences, Jodhpur 342005, Rajasthan→ | Inclusion criteria: All healthcare professionals in the age group of 20-45 years will be considered. Informed consent will be obtained from all participants at the beginning.→ | Exclusion criteria: o Chronic medical condition <br/ ><br>o Subjects already doing regular yoga <br/ ><br>o Psychiatric disorders or substance use disorders <br/ ><br>→ | | Intervention1: Kriya yoga: Kriya yoga will comprise in that order<br>1.Breath awareness (Ana pana)<br>2.Complete breath<br>3.Anulom Vilom (Alternate nostril breathing)<br>4.Om chanting: â??Oâ?? for three second & â??Mâ?? reaming breath with descending sound (Three rounds)<br>5.Gayatri Mantra <br>6.Shavasan (Deep Relaxation)<br>Kriya yoga should be practiced once a day for six weeks. <br><br>Control Intervention1: None: None<br>→ | Expected outcome: <br/ ><br>1.Improvement in DASS-21 Scores <br/ ><br>2.Improvement in PSS scores <br/ ><br>3.Meditative changes in absolute and relative power for different EEG frequency bands. <br/ ><br>4.Improvement in Autonomic function test parameters <br/ ><br>5.Subjective feeling of calmness and wellbeing. <br/ ><br>Timepoint: Baseline, three weeks from start of intervention, six weeks from start of intervention, one month after completion of intervention→ | | | | Yes | False | | |
| → | CTRI/2021/03/032369 | 24 May 2021 | Tele-Yoga programme for work-from-home employees due to Covid-19 pandemic | Effectiveness of Tele Yoga Based Psychosocial Programme on IT/ITeS Professionals Working from Home due to Covid-19 Pandemic | | Vani K V | 30-03-2021 | 20210330 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52318 | Not Recruiting | No | | | | 01-04-2021 | 150 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Vani K V→ | | SVYASA University, Dept. of Research, "Anveshana", 2nd Floor, Prashanti Kutiram, Swami Vivekananda Road, Kalluballu Post, Jigani, Anekal Taluk, Bengaluru â?? 560105, Karnataka. India. → | vijaya.majumdar@svyasa.edu.in→ | 9036800821→ | SVYASA Deemed University→ | Inclusion criteria: Employees working as IT/ITeS professionals in Inida <br/ ><br>Employees working on Day shift <br/ ><br>Employees who can speak Kannada and/or English <br/ ><br>Those who are able to practice yoga and willing to undergo the Tele Yoga program <br/ ><br>→ | Exclusion criteria: Those who have been regularly practicing yoga for the past 3 months <br/ ><br>Chronic psychiatric or health disorder which prevent the yoga practice. <br/ ><br>Participants will be screening through 20-item Self Reporting Questionnaire (cutoff - 8), a tool for screening for nonspecific psychological distress <br/ ><br>→ | | Intervention1: Self-Management of Excessive Tension (SMET) programme through Tele Yoga and also Psychosocial programme: Intervention Group: Tele Yoga with Psychosocial programme. <br><br>Duration : <br>Tele-Yoga, 40 minutes, 3 days a week, 3 months; <br> Psychosocial programme: 30 minutes, fortnightly, 3 months. <br><br>Total Duration: 480 minutes yoga + 180 minutes of Psychosocial programme.<br>Intervention2: Psychosocial programme: Group 1: Tele Yoga<br><br>Psychosocial Programme.<br> <br>Duration: 30 minutes, fortnightly, 3 months.<br><br>Total Duration: 3 hours.<br>Control Intervention1: Psychosocial programme: Psychosocial programme total duration of 3 hours spread in 3 months (six sessions of 30 mins duration each for 3 months)<br>Control Intervention2: Psychosocial Programme: Control Group: Psychosocial programme <br>Duration: 30 minutes, fortnightly, 3 months. Total Duration: 180 minutes.<br>→ | To Observe the changes in Perceived Stress of IT/ITes professionals working from home due to covid pandemicTimepoint: Three time points. <br/ ><br>Before thee intervention. <br/ ><br>After 3 months of interventions(12th week) <br/ ><br>Follow-up (24th week)→ | | | | Yes | False | | |
| → | CTRI/2021/03/032368 | 24 May 2021 | Comparison of baseline SOFA score and CURB 65 score in predicting patient severity and outcome in COVID-19 patients of ICU. | Comparative evaluation of baseline SOFA score and CURB-65 score in predicting patient severity and outcome in COVID-19 patients admitted to Intensive Care Unit. | | Department of Anaesthesia and Critical care | 30-03-2021 | 20210330 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52589 | Not Recruiting | No | | | | 01-04-2021 | 100 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Anvita Vineet→ | | Department of Anaesthesia and critical care
Vardhman Mahavir Medical College and Safdarjung Hospital Near AIIMS hospital
Ansari Nagar
New Delhi→ | doctorgusha@hotmail.com→ | 8447795934→ | VMMC and SAFDARJUNG HOSPITAL→ | Inclusion criteria: 1. Adult patients >18 years of age, of both genders <br/ ><br>2. Diagnosed COVID-19 positive by RT-PCR or Rapid Antigen Test <br/ ><br>→ | Exclusion criteria: 1. Inconclusive testing on RT-PCR <br/ ><br>2. Recovered COVID patients (post 14 days of first COVID-19 positive report) <br/ ><br>3. Pregnant females <br/ ><br>→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. To evaluate the baseline SOFA score and CURB-65 score individually for predicting severity of disease and final outcome in COVID-19 patients admitted to the Intensive care unit.Timepoint: 1. Admission <br/ ><br>2. Discharge or death→ | | | | Yes | False | | |
| → | CTRI/2021/03/032385 | 24 May 2021 | Use of three different drugs for reduction in severity of COVID-19 disease using Arterial Stiffness as a clinical marker
| Comparing efficacies of Combinations of Vitamin D3 and Magnesium,Cilnidipine and Telmisartan therapies for reduction in severity of COVID-19 disease using Arterial Stiffness as a clinical marker:A Randomized, Parallel group Comparative Study. - ASCOTH Study | | AIIMS Patna | 30-03-2021 | 20210330 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54420 | Not Recruiting | No | | | | 05-04-2021 | 160 | Interventional | Randomized, Parallel Group, Multiple Arm Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Investigator Blinded→Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Investigator Blinded | N/A | India→ | DrNeeraj Kumar→ | | Department of Trauma and Emergency
Clinical coordinator COVID-19
Room No:505,5th Floor OT Complex
B-Block
AIIMS Patna → | drneerajk@aiimspatna.org→ | 8210104972→ | AIIMS Patna→ | Inclusion criteria: RT PCR proved COVID-19 positive patients admitted in AIIMS Patna <br/ ><br>Age â?¥ 18 years < 70 years <br/ ><br>→ | Exclusion criteria: 1. Patients with severe CAD <br/ ><br>2. Congestive heart failure(CHF) <br/ ><br>3. Stage II hypertension <br/ ><br>4. Hypotension <br/ ><br>5. Patients on insulin, Diabetic Neuropathy, <br/ ><br>6. Diabetic Keto acidosis <br/ ><br>7. Stroke and peripheral arterial disorder <br/ ><br>8. Pre-existing Cardiovascular disease <br/ ><br>9. Recent MI <br/ ><br>10. Cardiac transplant within the last 12 months <br/ ><br>11. Pregnancy <br/ ><br>12. Patient with peripheral Edema <br/ ><br>13. Patient with Cardiac Arrhythmia <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Vitamin D Group with age normalized increase in Pulse wave velocity between 364-580 cm/sec (Arterial stiffness level: 20 Severe non ventilated patients in this group will receive vitamin D only with standard COVID-19 treatment as per institute COVID-19 therapy guidelines<br><br>Intervention2: Vitamin D Group with age normalized increase in Pulse wave velocity between 364-580 cm/sec ( Arterial stiffness level ): 20 Severe non ventilated patients in this Vitamin D Group will receive standard COVID-19 treatment, and in addition :<br>Day 1,2 & 3: Vitamin D3 60,000 IU BLD along with Magnesium Glycinate 250mg BD. <br>Day 4: Vitamin D3 60,000 IU BD along with Magnesium Glycinate 250mg BD. <br>Day 5,6,7 : Vitamin D3 60,000 IU B along with Magnesium Glycinate 250mg B.<br><br>Intervention3: CCB and ARB Active Therapy group with age normalized increase in Pulse wave velocity between 364-580 cm/sec <br>(Arterial stiffness level)<br>: 20 Severe non ventilated patients in this CCB and ARB Active Therapy group will receive standard COVID-19 treatment and in addition :<br>Day 1,2: Cilnidipine 10mg + Telmisartan 40 mg BD<br>Day 3,4,5,6 &7: Cilnidipine 10mg + Telmisartan 40 mg B<br><br>Intervention4: Vitamin D with CCB and ARB Active Therapy group â?? with age normalized increase in Pulse wave velocity between 364-580 cm/sec ( Arterial stiffness level ): 20 Severe non ventilated patients in this Vitamin D with CCB and ARB Active Therapy group will receive standard COVID-19 treatment and in addition :<br>Day 1,2: Cilnidipine 10mg + Telmisartan 40 mg B. <br>Vitamin D3 30,000 IU BLD alongwith Magnesium Glycinate 125mg BD.<br>Day 3: Cilnidipine 5mg + Telmisartan 20 mg B<br>Vitamin D3 30,000 IU BLD alongwith Magnesium Glycinate 125mg BD.<br>Day 4: Cilnidipine 5mg + Telmisartan 20 mg B<br>Vitamin D3 30,000 I→ | To study and compare efficacy of: <br/ ><br>1.Vitamin D3 with Magnesium Glycinate therapy. <br/ ><br>2.Cilnidipine + Telmisartan therapy. <br/ ><br>3.Vitamin D3 + Magnesium Glycinate + Cilnidipine + Telmisartan therapy. <br/ ><br>for reduction in severity of COVID-19 disease using non-invasive measurement of Arterial Stiffness as a clinical marker <br/ ><br>Timepoint: The Pulse wave velocity in both groups will be evaluated on Day 1, 3, 5 and at discharge or day 7 or on the day of clinical deterioration whichever is earlier.→ | | | | Yes | False | | |
| → | CTRI/2021/03/032367 | 24 May 2021 | THE OUTCOME OF HEMODIALYSIS IN COVID PATIENTS WITH CKD-RETROSPECTIVE COHORT STUDY | TOSTUDY THE PREDICTORS OF OUTCOME IN COVID PATIENTS WITH CKD ON DIALYSIS-RETROSPECTIVE STUDY IN KGMCH | | Self | 30-03-2021 | 20210330 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50375 | Not Recruiting | No | | | | 30-03-2021 | 66 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DR EDWARD JOHNSON→ | | KANYAKUMARI GOVERNMENT MEDICAL COLLEGE ASARIPALLAM NAGERCOIL
KANYAKUMARI
TAMILNADU KANYAKUMARI GOVERNMENT MEDICAL COLLEGE ASARIPALLAM NAGERCOIL
KANYAKUMARI
TAMILNADU→ | edwardjohnson2310@gmail.com→ | 9443392974→ | KANYAKUMARI GOVERNMENT MEDICAL COLLEGE→ | Inclusion criteria: RT PCR POSITIVE PATIENTS WITH CKD ON HEMODIALYSIS→ | Exclusion criteria: RT PCR POSITIVE PATIENTS WITHOUT CKD→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: CKD: OUTCOME OF COVID PATIENTS WITH CKD ON HEMODIALYSIS<br>→ | RT PCR POSITIVE PATIENTS WITH CKD ON HEMODIALYSIS HAS HIGH MORTALITY RATETimepoint: 8weeks→ | | | | Yes | False | | |
| → | CTRI/2021/03/032453 | 24 May 2021 | Severity of covid-19 disease in diabetes mellitus patients | Correlation between covid-19 disease severity and its outcome in diabetes mellitus patients | | Maulana Azad Medical College | 31-03-2021 | 20210331 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54590 | Not Recruiting | No | | | | 16-04-2021 | 60 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sanjit Kumar→ | | Department Of Medicine
Maulana Azad Medical College
Bahadur Shah Zafar Marg
New Delhi → | drsandeepgargmamc@gmail.com→ | 9968604280→ | Maulana Azad Medical College→ | Inclusion criteria: 1. Patients with covid-19 positive by RT-PCR with diabetes mellitus. <br/ ><br>2. Age of 18-65 years, of either sex.→ | Exclusion criteria: 1. Patients with obesity (BMI >30). <br/ ><br>2. Patients with renal, hepatic or other systemic <br/ ><br> disease. <br/ ><br>3. Patients with diagnosed coronary artery <br/ ><br> disease. <br/ ><br>4. Patients with other acute medical or surgical <br/ ><br> condition. <br/ ><br>5. Covid-19 positive patients admitted in <br/ ><br> intensive care units. <br/ ><br>6. Covid-19 positive patients with shock, ARDS, <br/ ><br> MODS. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To study the correlation between covid-19 disease severity and its outcome in diabetes mellitus patients.Timepoint: Less than or equal to nine months→ | | | | Yes | False | | |
| → | CTRI/2021/03/032444 | 24 May 2021 | A clinical trial of Yoga On Immunity In Doctors During COVID 19 Pandemic- A Pilot Study | Effect Of Yoga On Immunity In Doctors During COVID 19 Pandemic- A Pilot Study | | DST SATYAM | 31-03-2021 | 20210331 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54405 | Not Recruiting | No | | | | 03-04-2021 | 40 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Shazia Hasan→ | | Level 4, Department of Pharmacology, Aiims, Rishikesh → | saherzara@gmail.com→ | 9821425949→ | AIIMS, Rishikesh→ | Inclusion criteria: Doctors working during Covid 19 pandemic in AIIMS, Rishikesh→ | Exclusion criteria: 1. Not willing to participate <br/ ><br>2. Autoimmune disorders <br/ ><br>3. Immunodeficiency <br/ ><br>4. Doing yoga or any exercise for 3 months <br/ ><br>5. COVID positive <br/ ><br>6. Any structural deformity or not fit to perform Asan→ | | Intervention1: YOGA: Participants will receive yoga intervention for 12 weeks. Group will undergo training sessions online for at least 6 days, in the first week followed by practicing yoga once a day at home for next 12 weeks. Participants will be monitored digitally daily for compliance and addressing any difficulty in performing Yoga.<br>Control Intervention1: NIL: NIL<br>→ | Changes in levels of immunity markersTimepoint: 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/03/032471 | 24 May 2021 | Data Analysis of THINQURE 20 in COVID 19 Patients | A Non-Interventional, Retrospective, Observational Study to Analyze Safety, Efficacy and Tolerability of THINQURE 20 in COVID-19 Patients. | | Thinq Pharma CRO Limited | 31-03-2021 | 20210331 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54671 | Not Recruiting | No | | | | 12-04-2021 | 25 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Milind Gharpure→ | | A30 Rd Number 10 Wagle Estate MIDC Thane West Thane Maharashtra 400604 → | ravindra.mote@mediclincr.com→ | 8888884024→ | Mediclin Clinical Research→ | Inclusion criteria: We will consider the following criteria for retrospective analysis. <br/ ><br> <br/ ><br>1. Male or Female subjects of age 18 to 75 years (both inclusive). <br/ ><br>2. Subjects diagnosed with COVID-19 by RT-PCR. <br/ ><br>3. Patients provided oral & nasal swabs for test <br/ ><br>4. Females of child-bearing potential (i.e., who were not chemically or surgically sterilized or who were not post-menopause) must have had a negative urine pregnancy test. <br/ ><br>5. Females of child-bearing potential who have used a medically accepted method of contraception that was considered reliable in the judgment of the investigator. <br/ ><br>6. Subjects who have taken Thinqure 20 as prescribed by Investigator. <br/ ><br>→ | Exclusion criteria: Subjects were excluded on the following basis: <br/ ><br> <br/ ><br>1. Patients with a history of intracranial bleeding <br/ ><br>2. Patients without a completed medical history <br/ ><br>3. Patients, who were suffering from any haemoglobinopathies such as thalassemia that could interfere with oxygen carriage in the blood. <br/ ><br>4. Patients, who were smokers or consumed alcohol. <br/ ><br>5. Patients, who were suffering from active malignancy along with squamous cell or basal cell skin cancer. <br/ ><br>6. Female subjects who were pregnant or lactating or planning to become pregnant during the study period. <br/ ><br>7. Females who were not ready to use acceptable contraceptive methods during the course of study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Reduction in viral load from baseline to end of study visit.Timepoint: Day 1 to Day 5→ | | | | Yes | False | | |
| → | CTRI/2021/03/032451 | 24 May 2021 | Diagnostic performance of respiratory specimens in critically ill intubated COVID19 patients. | Diagnostic yield of respiratory tract samples in invasively ventilated critically ill patients with SARSâ??CoV2 infection- an observational study. | | Christian Medical College | 31-03-2021 | 20210331 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44442 | Not Recruiting | No | | | | 12-04-2021 | 100 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Lovely Thomas→ | | Division of Critical care
Christian Medical College and hospital
Ida Scudder road
Vellore
→ | drlovely82@yahoo.com→ | 04162282693→ | Christian Medical College and Hospital→ | Inclusion criteria: Age > 14 Years <br/ ><br>Clinical syndrome of suspected COVID19 case - fever, lower respiratory symptoms and respiratory failure <br/ ><br>Needing Invasive ventilation <br/ ><br>No CONTROL subjects <br/ ><br>→ | Exclusion criteria: not fulfilling the inclusion criteria→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Diagnostic yield in COVID 19 positive patient from NP+OP swab <br/ ><br>Diagnostic yield in COVID 19 positive patient from ETA <br/ ><br>Timepoint: baseline→ | | | | Yes | False | | |
| → | CTRI/2021/04/032473 | 24 May 2021 | A study to know about the clinical symptoms with which children with SARS CoVID2 infection present to hospital | A RETRO-PROSPECTIVE STUDY ON THE CLINICAL SPECTRUM OF SARS COV-2 INFECTION IN CHILDREN
| | Department of Pediatrics Maulana Azad Medical College | 01-04-2021 | 20210401 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53763 | Not Recruiting | No | | | | 05-04-2021 | 250 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DR URMILA JHAMB→ | | DEPARTMENT OF PAEDIATRICS, MAULANA AZAD MEDICAL COLLEGE, NEW DELHI → | ujhamb@hotmail.com→ | 9968604309→ | MAULANA AZAD MEDICAL COLLEGE→ | Inclusion criteria: All laboratory confirmed SARS-CoV2 cases with mild, moderate or severe symptoms→ | Exclusion criteria: All laboratory confirmed SARS-CoV2 cases who are asymptomatic at presentation and remain asymptomatic throughout their course of hospital stay. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | â?¢Severity of disease. <br/ ><br>â?¢Spectrum of clinical signs and symptoms. <br/ ><br>â?¢Association with underlying comorbidities. <br/ ><br>â?¢Outcome as discharge/mortality <br/ ><br>Timepoint: TIME OF DISCHARGE OR DEATH <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/04/032501 | 24 May 2021 | Comparison of effect of High Flow Nasal Cannula with Continuous Positive Airway Pressure in reducing incidence of invasive mechanical ventilation in severe COVID 19 patients. | Comparison of efficacy of HighFlow Nasal Cannula with Continuous Positive Airway Pressure in prevention of Invasive mechanical ventilation in COVID 19 patients with Acute Respiratory Distress Syndrome in Critical Care Unit- A Randomized Control Study - COVID HFNC | | SRM Medical College and Research Centre | 01-04-2021 | 20210401 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54364 | Not Recruiting | No | | | | 15-04-2021 | 60 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable | N/A | India→ | Gunasri K→ | | Room No 209,Second Floor,B Block, Department Of Anaesthesiology,SRM Nagar, Potheri, Kattankulathur. → | dranand@outlook.com→ | 9865282288→ | SRM Medical College→ | Inclusion criteria: All COVID -19 positive patients ( by RT-PCR) with paO2/Fio2 (P/F) â?? 150 to 250, with good sensorium, stable hemodynamics and pH > 7.2 <br/ ><br>Absence of nasal pathology <br/ ><br>→ | Exclusion criteria: Hemodynamically unstable patients <br/ ><br>Patients in shock/ severe acidosis <br/ ><br>Epistaxis, basal skull fracture <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J96- Respiratory failure, not elsewhereclassified
→ | Intervention1: High flow nasal cannula HFNC: High Flow Nasal Cannula (HFNC) therapy is an alternative method of oxygen supplementation in critical care unit with COVID 19 patients. HFNC has been recommended in management of COVID 19 patients with mild and moderate Adult Respiratory Distress Syndrome. It administers humidified oxygen with controlled fraction of inspired oxygen (FiO2 21-100%) at a maximal flow rate of 60L/min via nasal cannula. HFNC improves oxygenation by delivering increased fraction of inspired oxygen (FiO2), washing out and reducing dead space, generating PEEP and enabling patients to lie in awake prone position<br>Control Intervention1: CPAP NIV - Continuous Positive Airway Pressure Non Invasive Ventilation: CPAP NIV is a mode of ventilation used to treat mild to moderate ARDS<br>→ | To compare the efficacy of High Flow Nasal Cannula and Non Invasive Ventilation -Continuous Positive Airway Pressure in reducing need for invasive mechanical ventilation in patients with ARDS in COVID-19.Timepoint: 24 hours→ | | | | Yes | False | | |
| → | CTRI/2021/04/032541 | 24 May 2021 | Clinical trial of Madhav Rasayan in subjects of COVID 19. | Randomized controlled clinical trial to evaluate safety & efficacy of Madhav Rasayan in subjects of COVID 19. - Nil | | Shree Vishwavati Ayurvedic Chikitsalaya and Research Centre | 05-04-2021 | 20210405 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54622 | Recruiting | No | | | | 10-04-2024 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Tushar Saundankar→ | | OPD 2, First Floor, Shree Vishwavati Ayurvedic Chikitsalay and
Research Centre, Mangalwar Peth, Kolhapur. → | prasadpandkar9@gmail.com→ | 9881907552→ | Shree Vishwavati Ayurvedic Chikitsalay and Research Centre→ | Inclusion criteria: Confirmed COVID 19 patient with positive RT-PCR <br/ ><br>Moderate to severe symptomatic patients having no signs of ARDS (NEWS score less than or equal to 8) <br/ ><br>Subject willing to provide consent and follow up for study duration <br/ ><br>→ | Exclusion criteria: Patients with autoimmune disease or self-reports HIV or syphilis infection <br/ ><br>Proves to be unfit for the study as per the investigatorâ??s discretion <br/ ><br>Pregnant or lactating women <br/ ><br>Requiring ICU admission and mechanical ventilation at the screening <br/ ><br>Subjects with signs of ARDS <br/ ><br>Any other comorbidity which is the critical stage at screening which in investigator discretion finds subject not suitable for the trial participation→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Madhav Rasayan Tablets: Madhav rasayan tablets would be administered in 250 mg twice a day dosage for 10 days<br>Control Intervention1: Standard of care: Standard of care as per ICMR<br>protocol for 15 days<br>→ | Improvement of clinical symptoms including cough, breathlessness, gastric disturbance, anosmia, fatigue and myalgia on 10 point VAS scale 0- no symptom and 10-severe symptom <br/ ><br>Reduction in elevated levels of inflammatory markers such as CRP, LDH and Ferritin <br/ ><br>Subject population with negative RT-PCR for Covid 19Timepoint: From baseline, day 5 and day 10 ie end of study→ | | | | Yes | False | | |
| → | CTRI/2021/04/032531 | 24 May 2021 | Clinical trial to Compare effects and safety of Etanercept in Patients with Moderate COVID-19 | A Phase II, Multi-Centre, Double Blind, Randomized, Comparative Study to Evaluate Efficacy and Safety of Etanercept in Patients with Moderate COVID-19 (COVETA) - COVETA | | Lupin Limited | 05-04-2021 | 20210405 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53930 | Recruiting | No | | | | 12-04-2021 | 50 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | Dr Neelakant Krishnan→ | | 1st Floor, A Wing Green Bldg, NDDD Dept. Survey No. 46 A / 47 A, Village Nande, Taluka Mulshi, Pune, Maharashtra, India Pune → | chiragshah@lupin.com→ | 020-66749068→ | Lupin Limited→ | Inclusion criteria: 1. Male or female patients 18-65 years of age or older <br/ ><br>2. Willing and able to provide written informed consent prior to performing study procedures <br/ ><br>3. Confirmed SARS-CoV-2 infection within 10 days as determined by RT-PCR with presence of clinical features such as dyspnea and or hypoxia, fever, cough, SpO2 <94% (range 90-94%) on room air <br/ ><br>4. Have indicators of risk of progression: at least 1 inflammatory marker (e.g. D-dimer, IL6, CRP, ferritin, TNF) â?¥2 Ã? upper limit of normal (ULN) <br/ ><br>5. Females of childbearing potential must have a negative serum pregnancy test at screening/baseline. Women of childbearing potential must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for 3 months following last dose of study drug→ | Exclusion criteria: 1. Require invasive mechanical ventilation <br/ ><br>2. Presence of any of the following abnormal laboratory values at screening: o Absolute neutrophil count <1000 mm3 o Platelets <50,000 per mm3 o Hemoglobin <10 g/dL o Aspartate aminotransferase and alanine aminotransferase >5 Ã? ULN o Creatinine >1.5 Ã? ULN <br/ ><br>3. Patients with confirmed diagnosis of bacterial pneumonia or other active/uncontrolled fungal or viral infections at screening/baseline. <br/ ><br>4. Known active tuberculosis (TB), history of incompletely treated TB or suspected TB (with clinical features like coughing for longer than 3 weeks, hemoptysis, chest pain) or known extrapulmonary TB <br/ ><br>5. Known case of hepatitis B, hepatitis C or HIV infection. <br/ ><br>6. Known hypersensitivity to etanercept or any component of the formulation <br/ ><br>7. Patients having received Remdesivir prior to screening <br/ ><br>8. Patients receiving cytotoxic/immunosuppressant or biologic treatments (such as tumor necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], T-cell or B-cell targeted therapies (rituximab), interferon, or Janus kinase (JAK) inhibitors for any indication at study entry <br/ ><br>9. Participation in any other clinical trial of an experimental treatment for COVID-19 <br/ ><br>10. Any condition that, in the opinion of the investigator, is likely to interfere with the safety and efficacy of the study treatment or puts the patient at unacceptably high risk from the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Lupin Etanercept: Etanercept 50mg PFS dose subcutaneously on day 1 and Etanercept 25mg PFS subcutaneously on day 4<br>Control Intervention1: Placebo: Placebo 50mg PFS dose subcutaneously on day 1 and Placebo PFS dose 25mg subcutaneously on day 4<br>→ | Proportion of patients with clinical improvement (defined as â?¥2 points reduction on WHO Ordinal Scale)Timepoint: Day 14→ | | | | Yes | False | | |
| → | CTRI/2021/04/032535 | 24 May 2021 | Managing Health workforce during a pandemic | Workforce strategies in Healthcare to mitigate risk during COVID- 19 | | Dr Somu Self | 05-04-2021 | 20210405 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54519 | Not Recruiting | No | | | | 07-04-2021 | 50 | Observational | Other
Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Other Blinding and masking:Participant Blinded→Other<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Other Blinding and masking:Participant Blinded | N/A | India→ | SomuG→ | | Department of Hospital Administration
KMC Manipal MAHE
Madhavanagar Manipal → | somu.g@manipal.edu→ | 9448463186→ | KMC Manipal→ | Inclusion criteria: volunteers and covid warriors (healthcare personnel), understand and speak english→ | Exclusion criteria: Non volunteers and above the age of 55 years those who do not understand and speak english→ | | | outcome from the study is that it will help the stakeholderâ??s in preparing a protocol and have preparedness for the organization in case of similar situations in future. It can also benefit by framing health workforce policy for the benefit of the societyTimepoint: after 2 years→ | | | | Yes | False | | |
| → | CTRI/2021/04/032572 | 24 May 2021 | Can vaccination produce protective antibodies in people who fail to develop protective antibodies after recovery from COVID-19 infection | Humoral response to SARS-CoV-2 vaccination after failure to develop adequate humoral immunity post natural exposure to the virus | | Rajiv Gandhi Cancer Institute and Research Centre | 06-04-2021 | 20210406 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54034 | Not Recruiting | No | | | | 13-04-2021 | 35 | Observational | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shagun Bhatia Shah→ | | Department of Anaesthesiology
Major Operation Theatre
Ninth Floor; New Building
Rajiv Gandhi Cancer Institute and Research Centre
Sector-5
Rohini; Delhi-110085 Department of Anaesthesiology
Major Operation Theatre
Ninth Floor; New Building
Rajiv Gandhi Ca→ | drshagun_2010@rediffmail.com→ | 9891769779→ | Rajiv Gandhi Cancer Institute and Research Centre→ | Inclusion criteria: HCW <br/ ><br>Employed at RGCI <br/ ><br>Either sex <br/ ><br>18-70 years <br/ ><br>History of positive RT-PCR test for SARS-CoV-2 <br/ ><br>Either undetectable ( <1AU) or very low ( < 4.62 AU) IgG antibody titre <br/ ><br>Vaccinated <br/ ><br>→ | Exclusion criteria: Non Health Care Worker <br/ ><br>Not an employee of Rajiv Gandhi Cancer Institute <br/ ><br>Not vaccinated against COVID-19 <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | IgG antibody titreTimepoint: 7-14 days post first dose of vaccination <br/ ><br>28 days post second dose of vaccination→ | | | | Yes | False | | |
| → | CTRI/2021/04/032555 | 24 May 2021 | A Clinical Trial to Assess the Efficacy, Safety and tolerability of Colchicine for Covid-19 Disease Treatment in Indian Patients. | A prospective, pilot, clinical trial to evaluate the efficacy and safety of Colchicine for improvement of clinical outcomes during Coronavirus (COVID-19) disease treatment in high-risk Indian patients. - COLCOVIN | | Laxai Life Sciences Pvt Ltd | 06-04-2021 | 20210406 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54560 | Not Recruiting | No | | | | 07-04-2021 | 84 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Not Applicable→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Not Applicable | Phase 2 | India→ | Dr R M Chhabra→ | | Insignia Clinical Services Pvt. Ltd. Room # 512,Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North West, DELHI 110034, India → | Chhabradrrm@gmail.com→ | 011-49049115→ | Insignia Clinical Services Pvt. Ltd.→ | Inclusion criteria: Subjects meeting all the following criteria will be included in the study: <br/ ><br> <br/ ><br>1.Male & Female patients with age ranging from 40 to 65 years (both inclusive)& female (non-pregnant, non-lactating, post-menopausal, surgically sterilized or practicing a reliable method of birth control during the duration of study) <br/ ><br> <br/ ><br>2.Clinically stable condition for at least 6 months before enrollment. <br/ ><br> <br/ ><br>3.Confirmed diagnosis of at least moderate COVID-19 symptoms demonstrated by: <br/ ><br>a.Positivity in RT-PCR 2019-nCov test on respiratory tract (nasopharyngeal / oropharyngeal) specimens. <br/ ><br>b.Presence of clinical features of dyspnea and/or hypoxia, fever, cough, including SpO2 < 94% (range 90-94%) on room air, Respiratory Rate > 24 and < 30 breaths per minute. <br/ ><br> <br/ ><br>4.Significant COVID-19 symptoms, and judged by the treating doctor to be at high risk of progression to severe category due to presence of any of the following: <br/ ><br>a.Having at least one of the high-risk criteria, i.e, obesity (BMI â?¥ 30 kg/m2), diabetes mellitus, uncontrolled hypertension (diastolic blood pressure > 90 mm Hg systolic blood pressure â?¥150 mm Hg), known respiratory disease (including asthma or chronic obstructive pulmonary disease), known heart failure, known coronary disease; <br/ ><br>b.Demonstrating signs of cardiac injury due to Elevated troponin level, <br/ ><br> <br/ ><br>5.Patients who require hospitalization for control of disease at the time of study entry. <br/ ><br> <br/ ><br>6.Within 7 days from symptom onset or within 48 hours of laboratory diagnosis of SARS- CoV2. <br/ ><br> <br/ ><br>7.Able to take oral tablets and agreeing not to participate in any other study for duration of participation in this study. <br/ ><br> <br/ ><br>8.Willing to sign voluntary informed consent for participation in the study and willing to adhere to all protocol procedures. In case the subject is unable to provide informed consent than the same should be obtained from legally acceptable representative (LAR). <br/ ><br>→ | Exclusion criteria: 1.History of present illness (will be based on treating physicianâ??s opinion) <br/ ><br> <br/ ><br>a.Neurological and neurodevelopmental disorders. <br/ ><br>b.Congenital heart disease <br/ ><br>c.Severe heart disease or a history of clinically significant arrhythmias which may affect participants safety (According to the ECG or medical history). Corrected QT interval of 450 milliseconds or higher (according to the Bazett formula) on a 12 lead surface ECG / Abnormal ECG (to eliminate concerns that a potential interaction between colchicine and hydroxychloroquine could lead to excess QT prolongation) <br/ ><br> <br/ ><br>2.Requirement of oxygen supplementation greater than 8L nasal cannula at the time of enrollment. <br/ ><br> <br/ ><br>3.Treating physician clinical judgement that the patient will require mechanical respiratory support within 24 hours. <br/ ><br> <br/ ><br>4. Patient currently in Septic shock or with hemodynamic instability requiring vasopressors. <br/ ><br> <br/ ><br>5.History of cirrhosis. <br/ ><br> <br/ ><br>6.A subject undergoing hemodialysis. <br/ ><br> <br/ ><br>7.Severe gastrointestinal failure, severe gastrointestinal disorders, or stomach ulcer. <br/ ><br> <br/ ><br>8.Patient is currently taking colchicine for other indications (gout or Familial Mediterranean Fever). <br/ ><br> <br/ ><br>9.Patient with inflammatory bowel disease (Crohns disease or ulcerative colitis), chronic diarrhea or malabsorption <br/ ><br> <br/ ><br>10.Severe Hepatic Insufficiency (ALT or AST greater than 5 times ULN) or Renal Failure (eGFR using the MDRD equation for all subjects less than 30 mL per min). <br/ ><br> <br/ ><br>11.Patient received Remdesivir, Sarilumab, Tocilizumab, Lopinavir, Ritonavir or other immunomodulator given for COVID-19 treatment prior to study entry. <br/ ><br> <br/ ><br>12.Patient is on (and cannot discontinue) a strong CYP3A4 inhibitor (e.g. clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, atazanavir), a moderate CYP3A4 inhibitor (e.g. diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a Pgp Inhibitor (e.g. cyclosporine, ranolazine). <br/ ><br> <br/ ><br>13.Patients who may require IL 6 inhibitors as per clinical judgment of the investigator for management of inflammation at the time of study entry. <br/ ><br> <br/ ><br>14. Pregnant or lactating women women of a childbearing age with a positive pregnancy test <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J988- Other specified respiratory disorders
→ | Intervention1: Colchicine 0.5mg tablets plus Standard of Care: Colchicine 0.5mg tablets plus Standard of Care Dose 0.5 mg, Frequency BID, Route of Administration Oral, Duration of Therapy 28 Days<br>Control Intervention1: Standard of Care: Standard of Care<br>→ | Time to clinical improvement of 2-points on WHO 8-point ordinal scale <br/ ><br> <br/ ><br>Timepoint: 28 days (4 weeks) <br/ ><br> <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/04/032619 | 24 May 2021 | Comparison of the serum ferritin level with diabetic and non-diabetic Covid-19 patients. | FERRITIN - THE KEY MODEL INFLAMMATORY MARKER IN DIABETIC AND NONDIABETIC COVID
19 PATIENTS A RETOSPECTIVE STUDY | | Mukesh Kumar | 07-04-2021 | 20210407 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50992 | Not Recruiting | No | | | | 12-04-2021 | 400 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Mukesh Kumar→ | | DEPARTMENT OF BIOCHEMISTRY
RRMCH
BANGALORE → | sehrajmsmile2007@gmail.com→ | 7259215100→ | Rajarajeswari medical college and research center→ | Inclusion criteria: All type II Diabetic patients based on ADA criteria.→ | Exclusion criteria: 1) Type 1 diabetes mellitus <br/ ><br>2) Conditions that altered serum ferritin levels like: Hemochromatosis, Chronic alcoholics, chronic inflammatory conditions like SLE/ rheumatoid arthritis, Hepatitis, History of repeated blood transfusions, Iron deficiency anemia, Hypothyroidism, Chronic kidney disease. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | The Diabetic faces high probability to extreme serious complication from Covid -19 than non-diabetics. This study will help in the correlation between elevated serum ferritin with blood glucose level in Covid-19 diabetic patients during the treatment and also to rule out whether decreasing serum ferritin and controlling blood glucose helps in the betterment of Covid-19 patients.Timepoint: six months→ | | 28/02/2021 | | Yes | False | | |
| → | CTRI/2021/04/032613 | 24 May 2021 | A study on Immunity boosters for COVID-19 | Knowledge, attitude, and practices relating to Immunity boosters for COVID-19 among health sciences and Non-Health Science professionals. | | D Sreedhar | 07-04-2021 | 20210407 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54677 | Not Recruiting | No | | | | 12-04-2021 | 500 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Participant Blinded→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Participant Blinded | N/A | India→ | D Sreedhar→ | | Department of Pharmacy Management, Manipal College of Pharmaceutical Sciences, MAHE, Manipal → | d.sreedhar@manipal.edu→ | | Manipal College of Pharmaceutical Sciences→ | Inclusion criteria: Health science and Non-health science professionals→ | Exclusion criteria: Pediatric and Geriatric Population→ | | | The outcomes to be measured include preference of health science and non-health science professionals in immunity booster before and after the outbreak of COVID-19, perceived level of protection after taking the immunity boosters, awareness about the mechanism, side effects and medically advised dose of the supplements and role of immunity boosters in treatment and prevention of COVID-19Timepoint: 4 WEEKS→ | | | | Yes | False | | |
| → | CTRI/2021/04/032627 | 24 May 2021 | what happens to cardiac patients after covid pneumonia | Covid sequelae in patients with LV dysfunction | | UN Mehta institute of cardiology | 07-04-2021 | 20210407 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54680 | | No | | | | 23-04-2021 | 200 | Observational | Non-randomized, Multiple Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Senthilraj Thangasami→ | | Department of Caediology,UN Mehta institute of cardiology meghani nagar,ahmedabad→ | sencon85@yahoo.co.in→ | 9176258279→ | UN Mehta institute of cardiology→ | Inclusion criteria: Patients â?¥ 18 years of age with severe COVID-19 pneumonia documented by positive Reverse transcription polymerase chain reaction (RT-PCR) nasopharyngeal swab or with a CT-chest showing evidence of ground glass opacity with reduced ejection fraction less than 50% were considered eligible for the study.→ | Exclusion criteria: patients with covid pneumonia and normal left ventricular function <br/ ><br>patients with pneumonia other than covid→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | mortality <br/ ><br>recurrent hospital admission <br/ ><br>worsening heart failureTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/04/032615 | 24 May 2021 | Survey to Assess Potential Acceptance of COVID 19 Vaccine in Pregnant and Lactating Women | Potential Acceptance of COVID 19 Vaccine in Pregnant and Lactating Women | | NA | 07-04-2021 | 20210407 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54741 | Not Recruiting | No | | | | 12-04-2021 | 300 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ms Hafsa Shaikh→ | | Department of Pharmacy Practice, Manipal College of Pharmaceutical Sciences → | kanavworld@gmail.com→ | 7889271828→ | Manipal College of Pharmaceutical Sciences, MAHE→ | Inclusion criteria: Pregnant and Lactating Women→ | Exclusion criteria: Women who are surrogates are not eligible for the study <br/ ><br> <br/ ><br>Women who are not willing to participate due to any reason→ | | Intervention1: NA: NA<br>Control Intervention1: NA: NA<br>→ | at the end of the survey we will be able to determine prevalence and acceptance of COVID 19 vaccine in pregnant and lactating populationTimepoint: 24 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/04/032593 | 24 May 2021 | Vitamin D and Zinc for COVID-19 patients | A Randomized trial to determine the effect of vitamin D and zinc
supplementation for improving treatment outcomes among COVID-19
patients in India - CoVEDZ | | University Health Network | 07-04-2021 | 20210407 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54510 | Recruiting | No | | | | 15-04-2021 | 700 | Interventional | Randomized Factorial Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded→Randomized Factorial Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | N/A | India→ | Dr Yatin Dholakia→ | | Dr. Kantilal J Sheth Memorial Building, 84-A, Dr RG Thadani Marg, Siddharth Nagar, Worli, Mumbai, → | fmr@fmrindia.org→ | 02224934989→ | The Foundation for Medical Research→ | Inclusion criteria: Men or women aged more than or equals to 18 years old, RTPCR confirmed infection with SARS-COV2,oxygen saturation level of 90 or above, and provide informed consent→ | Exclusion criteria: Pregnancy, participants enrolled in other clinical trials, and daily use of multivitamins for the past 1 month→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: Placebo: Placebo for 60 days<br>Intervention2: Vitamin D: Daily Vitamin D3 :2000 IU for 60 days,Dose: 1 tablet/day,<br><br>Bolus Vitamin D3: 180000 IU, Oral Dose 3 tablets(each tablet contains 60,000 IU of D3) at the time of enrolment<br>Intervention3: Zinc: Daily Zinc Gluconate: 40 mg for 60 days,<br>Oral Dose: 1 tablet/day<br><br>Bolus Placebo: oral dose 3 tablets at enrolment<br>Intervention4: Vitamin D and Zinc: Daily vitamin D3 (2000 IU) and Zinc Gluconate (40 mg) for 60 days,Oral dose: 1 tablet/day,<br>Bolus Vitamin D3: 180000 IU,oral dose 3 tablets(each tablet contains 60,000 IU of D3) at the time of enrolment <br><br>Control Intervention1: Placebo: Placebo maintenance dose for 60 days,Oral Dose: 1 tablet/day,<br>Bolus Placebo: Oral dose 3 tablets at enrolment <br><br>→ | To determine the effect of vitamin D supplementation versus placebo on time to recovery among patients hospitalized with COVID-19; and to determine the effect of zinc supplementation versus placebo on time to recovery among patients hospitalized with COVID-19.Timepoint: Time point: Up to 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/04/032670 | 24 May 2021 | COVID-19 Related Lockdown and impact on Persons with Disabilities and their Caregivers. | Psychosocial Consequences of COVID-19 Related Lockdown on Persons with Disabilities and their Caregivers. | | ICSSR | 08-04-2021 | 20210408 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54909 | Not Recruiting | No | | | | 20-04-2021 | 160 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sobhana Hariharasubramanian→ | | Department of Psychiatric Social Work, LGBRIMH Tezpur → | sobhana@gmail.com→ | 9435183606→ | LOKOPRIYO GOPINATH BORDOLOI REGIONAL INSTITUTE OF MENTAL HEALTH→ | Inclusion criteria: â?¢ Adults with disability and who are listed in the data base for Deen Dayal Divyangjan Pension Scheme 2020-21 <br/ ><br>â?¢ Adult Family member or caregiver who is the member of the family who has been involved in the care of the PWD and has lived with the PWD for at least 12 months/ or during the time /or COVID -19 pandemic. <br/ ><br>→ | Exclusion criteria: â?¢ Caregivers reporting psychiatric or physical disorder which might interfere with the care of patients and his/her co-operation during interview <br/ ><br>â?¢ PWD listed in the data base without telephone contact number <br/ ><br>→ | | | Understanding the impact of Covid-19 related lockdown on on the persons with disability and their caregivers <br/ ><br>Timepoint: 8 months→ | | | | Yes | False | | |
| → | CTRI/2021/04/032647 | 24 May 2021 | To see the effect of Unani formulation as an add-on therapy along with Allopathic treatment in the Covid-19 patients | Clinical Evaluation of a Unani formulation as adjunct therapy/add-on therapy simultaneously with the Allopathic treatment (regimen specific) in the Covid-19 patients | | Ministry of AYUSH | 08-04-2021 | 20210408 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53666 | Not Recruiting | No | | | | 12-04-2021 | 80 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2 | India→ | Prof Dr Suhail Fatima→ | | Department of Amraze Niswa wa Qabala, School of Unani Medical education and research, Jamia Hamdard, Hamdard Nagar → | sfatima@jamiahamdard.ac.in→ | 9891306067→ | Jamia Hmadard→ | Inclusion criteria: RT-PCR confirmed diagnosis of COVID-19 <br/ ><br>Provides written informed consent <br/ ><br>Male or non-pregnant, non-lactating female aged more than 18 years upto 60 years <br/ ><br>Participants with clinical syndrome associated with COVID -19 infection, presenting with either: Uncomplicated upper respiratory tract viral infection, with non-specific symptoms such as fever, cough, sore throat, nasal congestion, sneezing/running nose, loss of taste and smell, shortness of breath <br/ ><br> OR <br/ ><br>Mild pneumonia with no signs of severe pneumonia or need of supplemental oxygen therapy <br/ ><br>Able to take the drug orally and comply with study procedures <br/ ><br>→ | Exclusion criteria: Participants with severe COVID-19 symptoms with respiratory rate > 30 breaths / min and severe respiratory distress or SpO2 < 90 % on room air at the time of admission <br/ ><br>Participants with altered mental state <br/ ><br>Laboratory abnormalities at Screening, including any of the following: <br/ ><br>(a)AST or ALT > 2.5 times ULN (upper limit of normal) <br/ ><br>(b) Absolute neutrophil count < 1500/μL <br/ ><br>(c) Serum Creatinine > ULN <br/ ><br>(d) Total bilirubin > ULN <br/ ><br>Participants with active hepatitis, tuberculosis and definite bacterial or fungal infections <br/ ><br>Participants with multiple organ failure requiring ICU monitoring and treatment <br/ ><br>Participants of respiratory failure and requiring mechanical ventilation <br/ ><br>Participants with persistent vomiting <br/ ><br>Participants with shock <br/ ><br>Patient who have participated in another investigational study within 3 months prior to enrolment in this study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 1. Habbe Zehrmohra<br>2. Habbe Tabasheer: 1. Habbe Zehrmohra one tablet of 250 mg twice daily orally for 14 days<br>2. Habbe Tabasheer two tablet of 250 mg each twice daily orally for14 days<br>Control Intervention1: Standard care: Need based may Include Azithromycin 500mg tablet one daily orally, Zinc and vitamin C, Oxygen Therapy for 14 days<br>→ | 1.RT-PCR for Covid-19 <br/ ><br>2. IL-6 and TNF-alfa <br/ ><br>3. IGg and IGm <br/ ><br>4. CRPTimepoint: Day Zero, 7th day and day15→ | | | | Yes | False | | |
| → | CTRI/2021/04/032688 | 24 May 2021 | Safety and immunogenicity study of mRNA based vaccine (HGCO19) against COVID-19 in healthy adult participants. | Randomized, Phase I/II, Placebo-controlled, Dose-Ranging, study to evaluate the Safety, Tolerability and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy adult subjects. | | Gennova Biopharmaceuticals Limited | 08-04-2021 | 20210408 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54697 | Recruiting | No | | | | 19-04-2021 | 620 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 1/ Phase 2 | India→ | Dr Amit Saraf→ | | Gennova Vaccine Formulation Centre and Research Laboratory,
BTS-2 Building, Chrysalis Enclave, Block-2,
Plot-2, International Biotech Park, Phase II, MIDC Hinjawadi, → | amit.saraf@gennova.co.in→ | 02039166300→ | Gennova Biopharmaceuticals Limited→ | Inclusion criteria: Applicable for both phases of study: 1. Male and female subjects aged between 18 to 70 years (Phase I) / 18 to 75 years (Phase II) (both inclusive) at randomization. 2. Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator. 3. Subject should be capable and willing to give voluntary written informed consent prior to inclusion in the study. 4. Able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. 5. Negative / Non-reactive for antibodies against SARS-CoV-2. 6. Negative / Non-reactive RT-PCR screening of nasopharyngeal swabs/suitable sample for SARS CoV-2 within 72 hours prior vaccination. 7. Male subjects who are sexually active or married and female subjects who are sexually active or married and are of child bearing potential should be willing to follow effective birth control methods for duration of the study. Note: Birth control methods include vasectomised subject/partner; or any 2 of the following methods: intrauterine device; oral, transdermal, injected, or implanted contraceptive; condoms; occlusive cap (diaphragm or cervical vault caps); spermicidal foam/gel/cream, etc. OR Exception to the above are male subjects who are infertile (post vasectomy with documented azoospermia or bilateral orchidectomy) and female subjects who are of non-childbearing potential [who are surgically sterile (hysterectomy, bilateral tubal ligation or bilateral salpingo-oophorectomy) or postmenopausal subjects with amenorrhea for at least 2 years]→ | Exclusion criteria: Exclusion Criteria for Phase I: <br/ ><br>1. Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection. <br/ ><br>2. Subjects with a BMI > 30 kg/m2 <br/ ><br>3. Protocol defined laboratory assessments outside the range/limit defined in Appendix 2. Any other laboratory value if â?¥ Grade 2 as per DAIDs criteria. <br/ ><br>Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, corrected version 2.1, July 2017, of the US National Institutes of Health <br/ ><br>4. Any illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, haematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. <br/ ><br>5. Individuals currently working in occupations with high risk of exposure to SARS-CoV-2 (e.g. healthcare worker in direct care of COVID-19 patients, front line workers in COVID 19 hotspots / outbreak areas). <br/ ><br>6. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine. <br/ ><br>7. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature â?¥38°C or â?¥100.4 °F) within 48 hours prior to vaccination. <br/ ><br>8. History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease. <br/ ><br>9. Subject has uncontrolled chronic disease including asthma, diabetes (HbA1c of >9%), hypertension (Systolic Blood pressure of >160 mm of Hg and/ or Diastolic Blood Pressure of >100 mm of Hg), thyroid disorder as assessed by the Investigator. <br/ ><br>10. Subjects who are pregnant or breast feeding or willingness/intention to become pregnant during the study. <br/ ><br>11. Prior major surgery or any radiation therapy within 4 weeks of Screening visit. <br/ ><br>12. Positive serologic test for HIV 1 and 2, HBsAg or HCV. <br/ ><br>13. Current (within 14 days prior to Screening visit) or anticipated concomitant immune modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day). <br/ ><br>14. Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination. <br/ ><br>15. Eczema or other significant skin lesion or infection at the site of vaccination. <br/ ><br>16. Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit. <br/ ><br>17. Bleeding diathesis or condition associated with prolonged bleeding. <br/ ><br>18. Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate. <br/ ><br>19. Any other condition which in the opinion of the Investigator may affect subjectâ??s safety or participation. <br/ ><br> <br/ ><br>Exclusion Criteria for Phase II: <br/ ><br>1. Subject with a medical history of COVID-19 infection or who has received vaccine to prevent COVID-19 infection. <br/ ><br>2. Any clinically significant laboratory values or illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiov→ | | Intervention1: HGCO19 (COVID-19 vaccine): Novel mRNA-based candidate vaccine candidate, using Spike (S)-protein of the virus as antigen.<br>HGCO19 will be administered IM at day 1 and day 29.<br>Control Intervention1: Placebo: Two doses of 0.5 ml of placebo (buffer), administered Intramuscularly at 4-weeks apart.<br><br><br>→ | 1. Occurrence and severity of local reactogenicity AEs for 7 days following each dose of vaccination. <br/ ><br>2. Occurrence, severity and relationship of systemic reactogenicity AEs for 7 days following each dose of vaccination. <br/ ><br>3. Occurrence, severity and relationship of unsolicited AEs up to 28 days following each dose of vaccination. <br/ ><br>4. Occurrence of SAE at any time during study participation. <br/ ><br>5. Changes in safety assessments including laboratory parameters and vital signs from baseline.Timepoint: Occurrence of solicited AEs within 7 days post each dose of vaccine. Occurrence of Unsolicited AEs upto 28 days post each dose of vaccine (day 29 and day 57). SAEs thorough out the duration of the study.→ | | | | Yes | False | | |
| → | CTRI/2021/04/032648 | 24 May 2021 | study to access effectiveness of new drug therapy (aspirin,atorvastatin and nicorandil) in covid-19 | To evaluate the efficacy and
safety of triple therapy with nicorandil, aspirin and atorvastatin
in patients with SARS-CoV -2 infection: randomized controlled
trial (NAAC trial)â?? - NAAC | | Dr Ambudhar Sharma | 08-04-2021 | 20210408 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51131 | Recruiting | No | | | | 10-05-2021 | 300 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3 | India→ | Ambudhar sharma→ | | Dr Ambudhar Sharma
Assistant professor cardiology
room no 107 1st floor superspeciality block
Dr RPGMC Tanda Dr Ambudhar Sharma
Assistant professor cardiology
room no 107 1st floor superspeciality block
Dr RPGMC Tanda→ | ambudhar1984@gmail.com→ | 09418048268→ | Dr. RPGMCTanda→ | Inclusion criteria: Age >18years <br/ ><br>A person with laboratory confirmation of covid -19, irrespective of signs and symptoms, <br/ ><br>Patients with moderate clinical severity(pneumonia with no signs of severe disease) and severe (severe pneumonia and mild ARDS) requiring hospital admission , Consenting to participate for the trial <br/ ><br>→ | Exclusion criteria: Documented significant liver disease / dysfunction (AST/ALT > 240), Myopathy and Rhabdomyolysis (CPK > 5x normal) , Allergy or intolerance to statins , Allergy or intolerance to aspirin , Patients taking the following medications: cyclosporine, HIV protease inhibitors, hepatitis C protease inhibitor, telaprevir, fibric acid derivatives (gemfibrozil), niacin, azole antifungals (itraconazole, ketoconazole) clarithromycin and colchicine , Prior statin use (within 30 days), Prior aspirin use (within 30 days) , History of active GI bleeding in past three months <br/ ><br>,Coagulopathy , Thrombocytopenia (Platelet count < 100000/ dl), Pregnancy, active breast-feeding , Patient unable to take oral or nasogastric medications <br/ ><br>,Moderate and severe ARDS, renal dysfunction, altered mental status, shock, thrombotic manifestation ,sepsis at presentation→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: ASPIRIN, ATORVASTATIN, NICORANDIL: all drugs will be given orally<br>ASPIRIN 325 mg stat f/b 75 mg od <br>atorvastatin 80 mg stat f/b 40 mg od hs <br>nicorandil 10 mg stat f/b 5 mg bd for 10 days or till hospital discharge whichever is later<br>Control Intervention1: standard therapy as per guidelines of ministry of health and family welfare new delhi india: HCQS 400 mg bd onday 1 f/b 400 mg od for 4 days<br>i/v methylprednisolone 0.5 -1 mg /kg for 3 days<br>LMWH/UFH prophylactic dose<br>→ | Primary <br/ ><br>Progression to any of following <br/ ><br> <br/ ><br>In-hospital mortality , moderate and severe ARDS , shock ,Occurrence of thrombotic events(VTE, ACS, ischemic stroke),Cardiac injury (acute heart failure,dysrythmia),Acute kidney injury,Impaired counciousness,Length of hospital stay <br/ ><br>,Length of mechanical ventilation (invasive plus noninvasive) <br/ ><br>Timepoint: 10 days or till hospital discharge whichever is later→ | | | | Yes | False | | |
| → | CTRI/2021/04/032707 | 24 May 2021 | Job Insecurity and Coping Strategies during the COVID-19 Pandemic in Mumbai, India | Relationship between Job Insecurity and Coping Strategies during the COVID-19 Pandemic in Mumbai, India | | Nikhil Lalla | 09-04-2021 | 20210409 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52020 | Not Recruiting | No | | | | 20-04-2021 | 134 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ms Anagha Deshmukh→ | | Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Udupi, Karnataka 576104 → | anagha.deshmukh@manipal.edu→ | 7259619947→ | Manipal College of Health Professions→ | Inclusion criteria: 1) Adults who know are employed. For a minimum of 1 year prior to the lockdown <br/ ><br>2) Individuals working in a private sector bank <br/ ><br>→ | Exclusion criteria: 1) Adults who are unemployed→ | | | the relationship between job insecurity and coping strategies among employed banking sector individuals during COVID-19 pandemicTimepoint: Single time point→ | | | | Yes | False | | |
| → | CTRI/2021/04/032705 | 24 May 2021 | To understand the teaching faculties perspectives and attitudes towards their listening health and their engagement in behaviours of noise reduction. | Perspective and attitudes of teaching facultiesâ?? towards their listening health in covid-19 pandemic situation â?? an online survey | | NIL | 09-04-2021 | 20210409 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54965 | Not Recruiting | No | | | | 18-04-2021 | 200 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | MsBhargavi PG→ | | Department of Speech and hearing
Manipal College of Health Professions
Madhav Nagar
Manipal
Karnataka
→ | g.kanaka@manipal.edu→ | 9845384136→ | Manipal College of Health Professions→ | Inclusion criteria: Faculties of all academicâ??s specialties at MCHP <br/ ><br>Faculties with work experience of minimum one year and have taken classes during COVID 19 pandemic situation <br/ ><br>→ | Exclusion criteria: Faculties spending less than one academic year at the time of the study. <br/ ><br>Temporary or visiting faculties. <br/ ><br>Faculties with non-teaching activities <br/ ><br>Faculties with hearing loss <br/ ><br>→ | | Intervention1: NIL: NIL<br>→ | As the questionnaire easy to administer and less time consuming, it can serve as a quick tool to gather information on hearing health. <br/ ><br>This information helps for better understanding regarding the safety and prevention messages that can be better tailored, wellbeing and their involvement in noise reduction behaviours. <br/ ><br>Results obtained to survey can be used to establish unique services for hearing protection targeted to college students and other young adults <br/ ><br>Timepoint: 2 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/04/032729 | 24 May 2021 | Immunity after vaccination in people who have suffered from COVID-infection and people who have never been infected with corona | SARS-CoV-2: Comparison of active immunity acquired by natural exposure versus inoculation of HCW | | Rajiv Gandhi Cancer Institute and Research Centre | 12-04-2021 | 20210412 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54807 | Not Recruiting | No | | | | 16-04-2021 | 64 | Observational | Non-randomized, Active Controlled Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Shagun Bhatia Shah→ | | Department of Anaesthesiology Major Operation Theatre Ninth Floor; New Building Rajiv Gandhi Cancer Institute and Research Centre Sector-5 Rohini; Delhi-110085
→ | drshagun_2010@rediffmail.com→ | 9891769779→ | Rajiv Gandhi Cancer Institute and Research Centre→ | Inclusion criteria: Health Care Worker <br/ ><br>Employed at Rajiv Gandhi Cancer Institute <br/ ><br>History of positive RT-PCR test for SARS-CoV-2 <br/ ><br>Either moderate (4.62-18 AU) or high ( >18 AU) IgG antibody titre <br/ ><br>Vaccinated against COVID-19→ | Exclusion criteria: Non-Health Care Worker <br/ ><br>Not employed at Rajiv Gandhi Cancer Institute <br/ ><br>Not vaccinated against COVID-19→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | IgG antibody titreTimepoint: 7-14 days post first dose of vaccination <br/ ><br>28 days post second dose of vaccination→ | | | | Yes | False | | |
| → | CTRI/2021/04/032747 | 24 May 2021 | COVID 19 and Plastic surgery | Plastic surgery related problems in a designated COVID hospital | | Dr vijay bhatia | 12-04-2021 | 20210412 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54580 | Not Recruiting | No | | | | 14-04-2021 | 42 | Observational | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sruja Narola→ | | Department of plastic surgery
First floor ,
S.V.P Hospital
B2 wing, opd room number 1 Department of plastic surgery
First floor ,
S.V.P Hospital
B2 wing, opd room number 1→ | bhatia101@gmail.com→ | 9825073828→ | Smt N.H.L Municipal medical college→ | Inclusion criteria: All plastic surgery related problems due to treatment and nursing care→ | Exclusion criteria: Pre-existing plastic surgery problems are excluded→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J00-J99- Diseases of the respiratory system
→ | Control Intervention1: NIL: NIL<br>→ | To study the possible surgical complications which may arise requiring plastic surgery interventionTimepoint: at baseline→ | | | | Yes | False | | |
| → | CTRI/2021/04/032755 | 24 May 2021 | Ayurveda medicines role in Treatment of COVID-19 | A clinical Study to evaluate the effect of Ayurveda medicines in the management of COVID-19 | | Sree Ramachandra Health services Pvt Ltd | 12-04-2021 | 20210412 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54896 | Not Recruiting | No | | | | 18-04-2021 | 200 | Interventional | Other
Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 4 | India→ | DrMRavi Kumar Reddy→ | | 21st KM Udayapura Kanakapura Main Road → | ramheart@gmail.com→ | | Sree Ramachandra Health Services Pvt Ltd→ | Inclusion criteria: 1. Confirmed case of COVID-19 infection by laboratory tests and suffering from clinical signs and symptoms fever, cough, sore throat, nasal congestion, malaise and headache associated with or without difficulty in breathing <br/ ><br>2. Age limit â?? 20 to 60 years, both Male & Female <br/ ><br>3. Patients whom ventilator support is not required <br/ ><br>4. Patients willing to give their consent to participate in the clinical trial <br/ ><br>→ | Exclusion criteria: 1. COVID-19 positive patients above 60 years of age & below 20 years <br/ ><br>2. Patients with acute renal failure or Stage 4 CKD or Liver Failure (AST/ALT >5 times elevated) <br/ ><br>3. Patients on Immuno-suppression therapy <br/ ><br>4. Pregnant Women or lactating mothers <br/ ><br>→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Kabasura kudineer: Kabasura kudineer 2 tablets taken thrice a day before food<br>Control Intervention1: Standard control group: only ongoing allopathic medicines Total duration of the therapy: 7 days or until discharge followed by Out-Patient medications.<br>→ | 1. Proportion of Out-Patients not hospitalised <br/ ><br>2. Early recovery in the signs and symptoms of COVID-19 by adding Ayurvedic medicines which are effective in fever, symptoms of respiratory tract and by enhancing immunity of body by adding Rasayana drugs <br/ ><br>Timepoint: Baseline , 4 th day , 7 th day, 14 th day→ | | | | Yes | False | | |
| → | CTRI/2021/04/032757 | 24 May 2021 | An online survey to study the Perspectives and attitude of college students towards their listening health in Covid-19 pandemic situation | Perspectives and attitude of college students towards their listening health in Covid-19 pandemic situation - An online survey | | Aiswarya Maria Mathew self | 12-04-2021 | 20210412 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54915 | Not Recruiting | No | | | | 18-04-2021 | 1300 | Observational | Other
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant Blinded→Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant Blinded | N/A | India→ | Bhargavi P G→ | | Department of Speech and Hearing
Manipal College of Health Professions
MAHE → | g.kanaka@manipal.edu→ | | Manipal College of Health Professions→ | Inclusion criteria: UG and PG college students→ | Exclusion criteria: history of congenital hearing loss→ | | Intervention1: NIL: NIL<br>→ | perspectives and attitudes of college studentsTimepoint: 2 Weeks→ | | | | Yes | False | | |
| → | CTRI/2021/04/032743 | 24 May 2021 | Immunity status of staff of AIIA against Covid-19 | To study the prevalence of serum IgG antibodies against SARS Cov-2 in scholars and employees of AIIA | | All India institute of Ayurveda | 12-04-2021 | 20210412 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55001 | Not Recruiting | No | | | | 20-04-2021 | 300 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Shalini Rai→ | | Room no 307 C block Rog nidan department All India institute of Ayurveda → | vd.raishalini@gmail.com→ | 9389423843→ | All India institute of Ayurveda→ | Inclusion criteria: Scholars and employees of AIIA <br/ ><br>Willing to participate in study→ | Exclusion criteria: Not willing to participate in study→ | | | To find prevalence of IgG antibodies against SARS Cov-2 infectionTimepoint: 1 year→ | | | | Yes | False | | |
| → | CTRI/2021/04/032766 | 24 May 2021 | To Compare and Evaluate the Effect of Corona affected Patients Undergoing Current Treatment Along with Food Supplements | An Open Label, Prospective, Randomized, Comparative, Multiple Arm Clinical Study to Evaluate the Immunomodulatory Efficacy of Nichi Glucan in Comparison with Conventional Therapeutic Regimen in Adult Subjects with Covid 19 caused by SARS-CoV2(B-CoV) | | NichiIn Biosciences Pvt Ltd | 13-04-2021 | 20210413 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54786 | Not Recruiting | No | | | | 15-04-2021 | 24 | Interventional | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr S R Tiruvalavan→ | | 24
Saradha College Road,
Clinical Research Department,
Room No. 102 → | drvaiyali@gmail.com→ | 9489225295→ | Shanmuga Hospital Pvt Ltd→ | Inclusion criteria: 1. Adult subjects between 18 and 65 years (both ages and sexes(inclusive) who are confirmed to be positive for SARS-CoV2 by way of RT-PCR in a laboratory approved by MoH-FW and the State Government. <br/ ><br>2. Patients with co-morbidities can be included. <br/ ><br>3. Patients who are found to be Covid19 positive requiring hospitalization. (Symptomatic or asymptomatic) <br/ ><br>4. Patients and LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period. <br/ ><br>5. Patients who are willing not to participate in any other clinical trial during participation in the current trial. <br/ ><br>→ | Exclusion criteria: 1. Patients who have previously been infected with SARS-CoV2 (symptomatic or <br/ ><br>Asymptomatic ) and recovered. <br/ ><br>2. Patients who are known to be HIV, HBV, HCV positive. <br/ ><br>3. Patients who have clinically abnormal renal or hepatic function values that are 3x times normal upper limit or in the opinion of the Investigator would impact the objectives of the study. <br/ ><br>4. Patients with complete cancer remission less than 3 years prior to the date of screening. <br/ ><br>5. Patients who have undergone major surgical procedure 4 weeks prior to randomization. <br/ ><br>6. Patients who are on anti-depressants, anti-psychotics. <br/ ><br>7. Patients with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; expect those that are considered etiology of said indication <br/ ><br>8. Females who are pregnant or nursing or planning to become pregnant during the study period. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: N-163 and AFO-202: AFO-202- 3 gm per day (1 gm per each meal)<br><br>N-163- 1 sachet per day<br>Control Intervention1: Standard Treatment and N-163 and AFO-202: Inj. Remdesivir 200 mg (Day 1)<br>Inj. Remdesivir 100 mg (Day 2 to Day 5)<br>Inj. Solumedrol 80mg IV BD<br>Inj. Clexane 40mg OD<br>Broad Spectrum antibiotics<br>Bronchodilators<br>Spirometry<br>Supportive measures<br>→ | 1. Covid19 Clinical Symptoms: Time taken for improvement, complete recovery, recurrence in typical symptoms not limited to pyrexia, respiratory distress, cephalic, malaise from baseline.Timepoint: 7th day or 14th day→ | | | | Yes | False | | |
| → | CTRI/2021/04/032804 | 24 May 2021 | Effect of AEV01 (Kutki) for Mild COVID19 Elderly patients | A Randomized, Placebo controlled, double blinded, parallel group clinical study to evaluate the efficacy and safety of AEV01 (Kutki) for Mild COVID19 in Elderly patients at risk of complications. | | PM Medical Centre | 13-04-2021 | 20210413 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54539 | Not Recruiting | No | | | | 18-04-2021 | 70 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Dr Ramesh Kannan→ | | Room no:2, Medicine OPD, Dept. of General medicine, PM Medical Centre, Wallajapet,
Ranipet, Tamil Nadu. → | drvmkmd@gmail.com→ | 9176677750→ | Sri Sai Ram Ayurveda Medical College→ | Inclusion criteria: 1. Willing and able to provide written informed consent prior to performing study procedures. <br/ ><br>2. Adult patients aged more than 50 years with SARS-CoV-2 infection and mild disease. <br/ ><br>Patients with Mild (uncomplicated) Illness is defined as â?? <br/ ><br>a.Diagnosed with COVID-19 by a standardized RT-PCR assay AND <br/ ><br>b.Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise, headache, muscle pain, or malaise, but with no shortness of breath AND <br/ ><br>c.No signs of a more serious lower airway disease AND <br/ ><br>d.RR <20, HR <90, oxygen saturation (pulse oximetry) > 94% on room air <br/ ><br>→ | Exclusion criteria: 1. Participants with moderate and severe illness of COVID19. <br/ ><br>2. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit of normal (ULN) <br/ ><br>3.Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30) <br/ ><br>4.Immuno-compromised patients on medications. <br/ ><br>5.Participation in any other clinical trial of an experimental treatment for COVID-19 <br/ ><br>6. Consideration by the investigator, for any reason, that the participant is not an eligible candidate to receive study treatment <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Capsule. AEV01 100 mg: AEV01 is a root extract of Kutki (Picrorhizakurroa 100 mg) <br>Given thrice daily orally after food for 30 days<br><br>Control Intervention1: Placebo capsule: Placebo capsule given thrice daily orally after food for 30 days.<br>→ | Time for clinical improvement , which is defined as; <br/ ><br>1. Normalization of pyrexia and body pain <br/ ><br>2. Respiratory rate less than 24/minute <br/ ><br>3.Spo2 rate greater than 94% <br/ ><br>4. Relief from cough and maintenance of above for more than 72 hours. <br/ ><br>Timepoint: Day 1 to Day 30→ | | | | Yes | False | | |
| → | CTRI/2021/04/032767 | 24 May 2021 | Safety measures taken to reduce the risk of COVID 19 infection among healthcare workers in a quality tertiary care hospital | Safety measures taken to reduce the risk of COVID 19 infection among healthcare workers in a quality tertiary care hospital | | Lona self | 13-04-2021 | 20210413 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53787 | Not Recruiting | No | | | | 19-04-2021 | 200 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Lona Lorain Fernandes→ | | department of hospital administration , PSPH, MAHE, Manipal → | lonalorain@gmail.com→ | 9901980345→ | Prasanna School of Public health→ | Inclusion criteria: doctors nurses administration staff who are able to understand English questionnaire→ | Exclusion criteria: those who are not willing to participate in the study→ | | Control Intervention1: Not applicable: Not applicable<br>→ | Sensitisation of the healthcare workers on COVID precautions and to ensure adequate infrastructure where neededTimepoint: 4 months→ | | | | Yes | False | | |
| → | CTRI/2021/04/032791 | 24 May 2021 | Study to Assess Efficacy and Safety of Inhaled Interferon-Beta Therapy for COVID-19 | A randomized, double-blind, placebo-controlled, Phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalized due to moderate COVID-19 - SPRINTER | | Synairgen Research Ltd | 13-04-2021 | 20210413 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53300 | Not Recruiting | No | | | | 04-06-2021 | 610 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 3 | Argentina;Belgium;Brazil;Colombia;France;Germany;India;Israel;Italy;Mexico;Netherlands;Portugal;Romania;Serbia ;Spain;United Kingdom;United States of America→ | Dr Annappa Kamath→ | | CRS Solution Consultants Department CoWrks, Coworking Spaces Pvt. Ltd. â?? RMZ Eco World, Ground Floor, Bay Area â?? Adjacent to Building 6A, Outer Ring Road, Devarabeesanahalli Village→ | Annappa.Kamath@PAREXEL.com→ | 918067169360→ | PAREXEL International Clinical Research Private Limited→ | Inclusion criteria: 1) Admitted to hospital due to the severity of their COVID-19 <br/ ><br> <br/ ><br>2) Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test was performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection <br/ ><br> <br/ ><br>3) Require oxygen therapy via nasal prongs or mask (OSCI score of 4) <br/ ><br> <br/ ><br>4) Provided informed consent <br/ ><br> <br/ ><br>5) Female patients must be greater than or equals to 1 year post-menopausal, surgically sterile, or using a protocol defined highly effective method of contraception <br/ ><br> <br/ ><br>6) Women should have been stable on their chosen method of birth control for a minimum of 3 months before entering the trial and should continue with birth control for 1 month after the last dose of inhaled interferon-beta (IFN-beta 1a)/matching placebo. In addition to the highly effective method of contraception (except for the practice of total sexual abstinence), a condom (in United Kingdom with spermicides) should be used by the male partner for sexual intercourse from randomisation (Visit 2) and for 1 month after the last dose of inhaled IFN-beta1a/matching placebo to prevent pregnancy <br/ ><br> <br/ ><br>7) Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered post-menopausal if they have been amenorrhoeic for 12 months prior to the planned date of randomisation without an alternative medical cause. The following age specific requirements apply: women less than 50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and if follicle stimulating hormone (FSH) levels are in the postmenopausal range; women greater than or equals to 50 years old will be considered post-menopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment. If, in the setting of the pandemic, the use of an acceptable birth control method is not possible, the decision to enroll a woman of childbearing potential should be based on the benefit-risk for the patient, which should be discussed with the patient at the time of the informed consent→ | Exclusion criteria: 1) Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay <br/ ><br> <br/ ><br>2) Non-invasive ventilation or high-flow oxygen (OSCI score of 5) <br/ ><br> <br/ ><br>3) Mechanical ventilation (continuous or intermittent continuous positive airway pressure or intubation) or admission to intensive care (OSCI score of â?¥ 6) <br/ ><br> <br/ ><br>4) Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay <br/ ><br> <br/ ><br>5) Any condition, including findings in the patients medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation <br/ ><br> <br/ ><br>6) Participation in previous clinical trials of SNG001 <br/ ><br> <br/ ><br>7) Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study <br/ ><br> <br/ ><br>8) Inability to use a nebuliser with a mouthpiece <br/ ><br> <br/ ><br>9) Inability to comply with the requirements for storage conditions of study medication in the home setting <br/ ><br> <br/ ><br>10) History of hypersensitivity to natural or recombinant IFN-β or to any of the excipients in the drug preparation <br/ ><br> <br/ ><br>11) Females who are breast-feeding, lactating, pregnant or intending to become pregnant <br/ ><br> <br/ ><br>12) Previous SARS-CoV-2 vaccination→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: SNG001: SNG001 nebuliser solution, 2 syringes each containing 0.65 mL. Patients will inhale study medication once a day for 14 days<br>Control Intervention1: Placebo: Placebo nebuliser solution, 2 syringes each containing 0.65 mL solution containing excipients of the SNG001 solution. Patients will inhale study medication once a day for 14 days<br>→ | Time to hospital discharge <br/ ><br>Time to recoveryTimepoint: Day 1 until Day 28 <br/ ><br>Day 1 until Day 28→ | | | | Yes | False | | |
| → | CTRI/2021/04/032768 | 24 May 2021 | to find out whether the use of
untubated oxygen therapy versus intubated mechanical ventilation(MV) post ICU discharge in COVID patients contributed to any changes in respiratory parameters | To compare the respiratory, physiological endurance and health related quality of life parameters in COVID 19 patients receiving non-invasive oxygen therapy (NIV) versus mechanical ventilation(MV) post ICU discharge
| | PGIMER | 13-04-2021 | 20210413 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54913 | Not Recruiting | No | | | | 01-05-2021 | 50 | Observational | Non-randomized, Active Controlled Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Amarjyoti Hazarika→ | | Dept of anaesthesia and intensive care
4th floor,Nehru hospital
PGIMER,Sector 12
→ | amarjyoti28@rediffmail.com→ | 01722756500→ | PGIMER→ | Inclusion criteria: All COVID-19 patients of age 18yrs and above having PaO2/FiO2(P/F) ratio less then 200mmHg at admission in ICU ( severe COVID ARDS) and were discharged from it.→ | Exclusion criteria: Exclusion criteria: <br/ ><br>1.Patient died in COVID ICU <br/ ><br>2.Patient age less then 18yrs of age <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | Control Intervention1: nil: nil<br>Control Intervention2: nil: nil<br>→ | To compare respiratory parameters between patients receiving NIV versus MV at 3 months post ICU discharge.Timepoint: To compare respiratory parameters between patients receiving NIV versus MV at 3 months follow up post ICU discharge.→ | | | | Yes | False | | |
| → | CTRI/2021/04/032795 | 24 May 2021 | Use of high flow nasal cannula in Covid 19 patients with respiratory failure | Role of High Flow Nasal Cannula (HFNC) as a treatment modality in patients with hypoxemic respiratory failure due to COVID - 19 | | Government Medical College Vadodara | 13-04-2021 | 20210413 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53163 | Not Recruiting | No | | | | 21-04-2021 | 60 | Observational | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 4 | India→ | Dr Devyani Desai→ | | Department of Anaesthesiology, Government Medical College Vadodara
→ | devyani.dr@gmail.com→ | 9909983168→ | Maharaja sayajirao University of Baroda→ | Inclusion criteria: COVID â?? 19 pneumonia (Diagnosed with polymerase chain reaction) <br/ ><br>Age more than 18 years of either gender <br/ ><br>Acute Hypoxemic Respiratory Failure <br/ ><br>Admission to intensive care unit <br/ ><br>Supported by high flow nasal cannulae <br/ ><br>→ | Exclusion criteria: Intubation prior to HFNC therapy <br/ ><br>Uncooperative and neurologically (Glasgow coma scale less than equal to 12) unstable patients <br/ ><br>Patients with haemodynamic instability <br/ ><br>Patients with primary pulmonary disease, respiratory acidosis in the first blood gases (pH < 7.2,pCO2 â?¥ 50) <br/ ><br>In all conditions where PEEP is contraindicated like in presence of pneumothorax, large bullae in lungs or haemodynamic instability. <br/ ><br>Patient not accepting nasal cannula due to irritation or discomfort <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: High flow nasal cannula: A high flow nasal cannula (HFNC) system needs to have two important components in addition to providing oxygen. As it involves very high flow, it should:<br>1. Be able to warm the delivered air; cold air will be irritating to the airway and significant heat loss can occur from the patientâ??s body. <br>2. It should be able to humidify the air; dry air is an irritant to the airways and dries up secretions and mucous membranes.<br>The HFNC is thus, not a simple oxygen delivery cannula with high flows, but has some additional engineering modifications.<br><br>Intervention2: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | To describe the use of HFNC in COVID â?? 19 patients with acute hypoxemic respiratory failure and evaluation of ROX index over time in patients treated with HFNC.Timepoint: 6 months or cessation of COVID 19 pandemic whichever is earlier→ | | | | Yes | False | | |
| → | CTRI/2021/04/032793 | 24 May 2021 | Exploring the role of blood clotting pathway in patients with severe COVID-19 infection. | Exploring the role of hemostatic pathway in patients with severe SARS CoV-2 infection â?? A prospective proof of concept study | | Christian Medical College Vellore | 13-04-2021 | 20210413 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54760 | Not Recruiting | No | | | | 19-04-2021 | 100 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Manoj Job S B→ | | Department of Medical Intensive Care
Christian Medical College, Vellore → | drmanojjob@gmail.com→ | 9489663692→ | Christian Medical College→ | Inclusion criteria: Evidence of SARS CoV 2 infection diagnosed by a RT-PCR. <br/ ><br>Fulfill WHO classification of severity of infection. <br/ ><br>→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Determine the presence of a hypercoagulable state in SARS CoV2 infection. <br/ ><br> <br/ ><br>Timepoint: Baseline, 5 days→ | | | | Yes | False | | |
| → | CTRI/2021/04/032788 | 24 May 2021 | Effect of Telerehabilitation based Physiotherapeutic exercises on Physical Function and Quality of life. in patients with COVID 19. | Effect of Telerehabilitation based physiotherapy programme on Quality of life and functional capacity in patients with COVID-19: A Feasibility Study | | nil | 13-04-2021 | 20210413 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55016 | Not Recruiting | No | | | | 27-04-2021 | 20 | Interventional | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Vijay Pratap Singh→ | | Kasturba Medical College, Department of Physiotherapy, Bejai, Mangalore → | vijaypratap.singh@manipal.edu→ | 8967035789→ | Kasturba Medical College, Mangalore, MAHE.→ | Inclusion criteria: In-patient as well as post-discharge COVID-19 patients with a definitive PCR reported diagnosis of COVID-19. <br/ ><br>Age 18-75 years. <br/ ><br>Patients with MOCA score more than 26. <br/ ><br>Independent ambulation. <br/ ><br>Patients with minimum one smartphone in house with good internet connectivity. <br/ ><br>→ | Exclusion criteria: Any other respiratory condition. <br/ ><br>Any Cardiac condition (moderate to severe). <br/ ><br>Other neuromuscular condition affecting respiratory or physical function. <br/ ><br>Visual impairments causing difficulty in operating the smartphone. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Telerehabilitation: Breathing exercises, Strength training, Aerobic exercises.<br>Control Intervention1: nil: nil<br>→ | 6 Minute Walk Test, SF-36 Scores.Timepoint: 6 Minute Walk Test, SF-36 Scores.→ | | | | Yes | False | | |
| → | CTRI/2021/04/032845 | 24 May 2021 | Yoga interventions for the management of COVID 19 in asymptomatic patients | Yoga interventions for the management of COVID 19 in asymptomatic patients: A mixed method study | | R ARCHANA | 15-04-2021 | 20210415 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52521 | Not Recruiting | No | | | | 08-05-2021 | 60 | Interventional | Other
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | R ARCHANA→ | | DEPARTMENT OF PHYSIOLOGY, SAVEETHA MEDICAL COLLEGE AND HOSPITAL THANDALAM → | dr.rarchana@gmail.com→ | 09840608149→ | SAVEETHA MEDICAL COLLEGE AND HOSPITAL→ | Inclusion criteria: All willing Male and Female adult patients â?¥18 years and â?¤60 years of age at the time of recruitment→ | Exclusion criteria: Explicit non-willingness to be a part of the research study <br/ ><br>Patients with Severe Acute respiratory Distress syndrome and who were already practicing yoga or meditation <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: yoga: 1. Simple pranayama â?? Sheetali & Bhramari Pranayama (10 minutes)<br>2. Yoga nidra (10 minutes)<br><br>Control Intervention1: NIL: NIL<br>→ | Information on whether Yoga intervention have any impact of COVID 19 patients in terms of reduction of symptoms, and reduction in mental stress, anxiety or depression <br/ ><br>Timepoint: 3 months <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/04/032816 | 24 May 2021 | Fetomaternal Outcome In COVID-19 Positive Pregnant Women - A Cohort Study | Fetomaternal Outcome In COVID-19 Positive Pregnant Women - A Cohort Study | | NA | 15-04-2021 | 20210415 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53584 | Not Recruiting | No | | | | 15-04-2021 | 78 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Mahak Dabas→ | | Room No. 16, Vishram Sadan, Department Of Obstetrics And Gynecology, Bhagat Phool Singh Government Medical College For Women, Khanpur Kalan, Sonepat → | siwachsunita@ymail.com→ | 9812266400→ | BPS GMC (W), KHANPUR KALAN→ | Inclusion criteria: pregnant women with COVID-19 positive by RT- PCR→ | Exclusion criteria: pregnant women with COVID-19 negative by RT-PCR→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Demographic profile and laboratory finding. Incidence of symptoms pertaining to COVID-19 <br/ ><br>Timepoint: Demographic profile and laboratory findings. <br/ ><br>Incidence of symptoms pertaining to COVID-19 on getting covid positive on day0. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/04/032823 | 24 May 2021 | Adverse events following COVID-19 vaccination | Adverse events following COVID-19 vaccination in a tertiary care hospital | | Dr Chandralekha N | 15-04-2021 | 20210415 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54865 | Not Recruiting | No | | | | 17-04-2021 | 500 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Chandralekha N→ | | Department of pharmacology
Father Muller Medical College, Mangalore Department of Pharmacology
Father Muller Medical College
Mangalore→ | smilekha25@fathermuller.in→ | 9743701662→ | Father Muller Medical College, Mangalore→ | Inclusion criteria: All health care workers both males and females of age more than 18 years including doctors, nurses, allied health science staff, paramedicals, students, clerical staff, support staff of FMCI who have voluntarily received 1st and 2nd dose of Covid-19 vaccination and who consent to give information about Covid -19 vaccine adverse events→ | Exclusion criteria: Covid-19 vaccinated health care worker not willing to provide any adverse event information following Covid-19 vaccination→ | | Control Intervention1: NIL: NIL<br>→ | We are looking for ADRs like fever, head ache, myalgia, nausea, vomiting, diarrhea, pain abdomen, sore throat, cough, dizziness, injection site pain etcTimepoint: 0-12 months -data collection <br/ ><br>13-18 months- data analysis <br/ ><br>18-24 months - publication <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/04/032825 | 24 May 2021 | Link between the levels of antioxidants like Glutathione peroxidase, Superoxide Dismutase and Catalase with that of the levels of related micronutrients like Selenium, Zinc, Copper and Iron in the outcome of patients with COVID19 | Significance of Micronutrients and Antioxidants in the Outcome of Patients with COVID19 | | Post Graduate Research Grant | 15-04-2021 | 20210415 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55151 | Not Recruiting | No | | | | 01-05-2021 | 200 | Observational | Single Arm Trial
Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:→Single Arm Trial<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Ravindra Maradi→ | | Associate Professor
Department of Biochemistry,
Kasturba Medical College,
Manipal - 576104 → | ravi.maradi@manipal.edu→ | 9448767663→ | Kasturba Medical College, Manipal→ | Inclusion criteria: For this study, I will be recruiting symptomatic COVID19 patients between the age of 18 and 80.→ | Exclusion criteria: Pregnant women, Patients with pre-existing liver or kidney complications, patients with hypothyroidism, patients with Biliary Tract Obstruction, Gastrectomy patients→ | Health Condition 1: B342- Coronavirus infection, unspecified
→ | | For COVID19 patients, the level of Zinc is expected to be less thaan 0.7 microgram/ml, copper between 80 and 160 mg/dl, Iron between 60 and 160 microgram/dl Selenium <br/ ><br>to be below 70 ng/ml along with low antioxidant levelsTimepoint: 5 months→ | | | | Yes | False | | |
| → | CTRI/2021/04/032865 | 24 May 2021 | COVID-19 and blood cancer registry | COVID-19 with Hematological Cancers Registry of India - CHCRI registry | | Tata Memorial Hospital Mumbai | 16-04-2021 | 20210416 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54950 | Not Recruiting | No | | | | 21-04-2021 | 50 | Observational | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Lingaraj Nayak→ | | Room number 81
Main Building
Tata Memorial Hospital
Mumbai → | lingarajnayak86@gmail.com→ | 9167294976→ | Tata Memorial Hospital, Mumbai→ | Inclusion criteria: 1)Patients of ages above 18 years who have a current or previously diagnosed hematologic cancer within the past five years. <br/ ><br>2)Diagnosed to have concomitant COVID-19 infection after 1stMarch 2020 through RT-PCR COVID-19 or antigen-based testing. <br/ ><br>→ | Exclusion criteria: 1)Patients who are not on any treatment for hematologic cancer and are in remission formore than five years <br/ ><br>2)Patients/family members unwilling to giving informed consent <br/ ><br>3)Definitive diagnosis of hematologic cancer not made ante-mortem or post mortem <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | | COVID-19 infection related mortality in patients with hematological malignanciesTimepoint: At Day 30 and 3 month.→ | | | | Yes | False | | |
| → | CTRI/2021/04/032876 | 24 May 2021 | The influence of self-compassion ability (to be compassionate towards oneself) and resilience ability (the ability to bounce back adverse life events) on perceived stress and coronaphobia (fear of getting affected by corona virus)among nurses during the Covid-19 pandemic in India | Relationships of self-compassion and resilience on perceived stress and coronaphobia among nurses during the Covid-19 pandemic in India | | Mariya Justin | 16-04-2021 | 20210416 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55211 | Not Recruiting | No | | | | 25-04-2021 | 130 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Mariya Justin→ | | Room no.5, Department of Clinical Psychology, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal → | anagha.deshmukh@manipal.edu→ | 7259619947→ | Manipal College of Health Professions→ | Inclusion criteria: -Nurses who have bachelor degree or diploma in Nursing. <br/ ><br>-Nurses who have worked for minimum two months during the months of March to August during the COVID pandemic. <br/ ><br>-Nurses working in COVID and Non-COVID hospitals in India.→ | Exclusion criteria: -Nurses working in other countries.→ | | | Relationships of self-compassion and resilience on perceived stress and coronaphobia among nurses during the Covid-19 pandemic in India.Timepoint: December2020 - May 2021→ | | | | Yes | False | | |
| → | CTRI/2021/04/032864 | 24 May 2021 | Impact of COVID-19 on Heart Failure Hospitalization and Outcome in India â?? A Cardiological Society of India Study | Impact of COVID-19 on Heart Failure Hospitalization and Outcome in India â?? A Cardiological Society of India Study (CSI-HF in COVID 19 Times Study â?? â??The COVID C-HF Studyâ??) | | Cardiological Society of India | 16-04-2021 | 20210416 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54968 | Recruiting | No | | | | 19-04-2021 | 40000 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Jayagopal P B→ | | Lakshmi Hospital, Chittur Road, Palakkad → | csichfcovidstudy@gmail.com→ | 9847023777→ | Director and Senior Interventional Cardiologist→ | Inclusion criteria: In this multicentric, retrospective, cross-sectional registry, we plan to retrospectively include consecutive patients presenting with acute HF at various participating hospitals across the Indian states/ union territories during a 6-months period in 2020 (1st of July to 31st December 2020). All cases of acute HF admitted during the corresponding period in the year 2019 will serve as historical controls.The parameters to be studied include type of HF, new-onset or worsening of pre-existing heart failure, clinical characteristics on index admission, risk factors, etiology for heart failure, history previous myocardial infarction, history of previous hospital admissions, treatment received during hospital admission, diagnostic coronary angiography, percutaneous coronary interventions, and coronary artery bypass graft surgery rates.→ | Exclusion criteria: Patients with a first acute myocardial infarction in the 2 weeks preceding clinical presentation will be excluded. Patients with alternative diagnoses clearly causative of symptoms will also be excluded.→ | Health Condition 1: I504- Combined systolic (congestive) anddiastolic (congestive) heart failure
→ | Intervention1: NIL: NIL<br>→ | 1.To study the change in the number of acute HF admissions in various hospitals in India during the period from 1st of July to 31st December 2020 (COVID-19 era) compared to corresponding period in 2019. <br/ ><br>2.To study in-hospital mortality rates of ADHF admitted to the various hospitals during the COVID-19 era compared to corresponding period in 2019. <br/ ><br>3.To study care of patients with LVAD and Heart transplant during COVID-19 times <br/ ><br>4.To study the benefits of prophylaxis with HCQ/others <br/ ><br>Timepoint: The period from 1st of July to 31st December 2020 (COVID-19 era) compared to corresponding period in 2019→ | | | | Yes | False | | |
| → | CTRI/2021/04/032904 | 24 May 2021 | To see if Remdesivir, an antiviral drug helped in reducing the hospital stay and helped patients with COVID 19infection recover faster? | To study the clinical outcomes in hospitalized patients, receiving Remdesivir for moderate/severe COVID 19 infection, during August 2020 to October 2020 in a designated COVID hospital.
| | Dr Punam Bhende | 19-04-2021 | 20210419 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54297 | Not Recruiting | No | | | | 20-04-2021 | 150 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Punam Bhende→ | | 15 Shashwath Florence
Opposite Shree Krishna Hospital
Karamsad Anand Gokal Nagar Karamsad 388325→ | punamvb@charutarhealth.org→ | 9480703214→ | H M Centre for Medical Care and Research→ | Inclusion criteria: .→ | Exclusion criteria: Not Applicable→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | | Death, Discharge, Length of stay in hospital, duration of O2therapyTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/04/032942 | 24 May 2021 | Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) in Healthy Volunteers | An Adaptive, Seamless Phase 1, Followed by Phase 2 Randomized, Double-blind, Multicenter Study to Evaluate the Safety, Reactogenicity, Tolerability and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (BBV152) in Healthy Volunteers. - BBV152 | | Bharat Biotech International Limited | 19-04-2021 | 20210419 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55080 | Recruiting | No | | | | 26-04-2021 | 190 | Interventional | Other
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Double Blind Double Dummy→Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Double Blind Double Dummy | Phase 2 | India→ | Dr V Krishna Mohan→ | | Bharat Biotech International Limited
Genome Valley
Shmaeerpet Bharat Biotech International Limited
Genome Valley
Shmaeerpet→ | kmohan@bharatbiotech.com→ | 04023480567→ | Bharat Biotech International Limited→ | Inclusion criteria: Phase 1 (Completed) <br/ ><br>1. Ability to provide written informed consent (Audio video consent for vulnerable <br/ ><br>subjects). <br/ ><br>2. Participants of either gender of age between â?¥18 to â?¤55 years. <br/ ><br>3. Good general health as determined by the discretion of investigator (vital signs (heart rate â?¥60 toâ?¤100 bpm; blood pressure systolic â?¥90 mm Hg and <140 mm <br/ ><br>Hg; diastolic â?¥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical <br/ ><br>history, and physical examination). <br/ ><br>4. Expressed interest and availability to fulfill the study requirements. <br/ ><br>5. For a female participant of child-bearing potential, planning to avoid becoming <br/ ><br>pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination <br/ ><br>6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ ><br>7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ ><br>8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination <br/ ><br>9. Agrees not to participate in another clinical trial at any time during the study period. <br/ ><br>10. Agrees to remain in the study area for the entire duration of the study. <br/ ><br>11. Willing to allow storage and future use of biological samples for future research. <br/ ><br> <br/ ><br>Phase 2: <br/ ><br>1. Ability to provide written informed consent (Audio video consent for vulnerable subjects). <br/ ><br>2. Participants of either gender of age between â?¥12 to â?¤ 65 years. <br/ ><br>3. Good general health as determined by the discretion of investigator (vital signs (heart rate â?¥60 toâ?¤100 bpm; blood pressure systolic â?¥90 mm Hg and <140 mm <br/ ><br>Hg; diastolic â?¥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination). <br/ ><br>4. Expressed interest and availability to fulfill the study requirements. <br/ ><br>5. For a female participant of child-bearing potential, avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study <br/ ><br>enrolment until at least four weeks after the last vaccination and agrees not to participate in another clinical trial at any time during the study period. <br/ ><br>6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ ><br>7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination <br/ ><br>8. Participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination. <br/ ><br>9. Agrees to remain in the study area for the entire duration of the study. <br/ ><br>10. Willing to allow storage and future use of biological samples for future research. <br/ ><br>Phase 2 Extension: <br/ ><br>The participants enrolled in Phase 2 part of the study and received two doses of the <br/ ><br>BBV152 (6μg) vaccine are eligible. <br/ ><br>→ | Exclusion criteria: Phase 1: <br/ ><br>1. History of any other COVID-19 investigational vaccination. <br/ ><br>2. Unacceptable laboratory abnormality from screening (prior to first vaccination) <br/ ><br>or safety testing, as listed below [Abnormal Complete Blood Count (CBC), Random blood sugar level, Renal function test (serum urea and Creatinine), liver function tests, urine analysis report, Positive serology for hepatitis C or HIV antibody or hepatitis B surface antigen]. <br/ ><br>(Subjects will be informed if their results are positive for hepatitis C, HIV 1 & 2 antibody or hepatitis B surface antigen (HBsAg) and will be referred to a primary <br/ ><br>care provider for follow up of these abnormal laboratory tests.) <br/ ><br>3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and/or ELISA method. <br/ ><br>4. Health care workers. <br/ ><br>5. For women, a positive serum pregnancy test (during screening within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of administering each dose of vaccine). <br/ ><br>6. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness <br/ ><br>such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ ><br>7. Medical problems as a result of alcohol or illicit drug use during the past 12 months. <br/ ><br>8. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period. <br/ ><br>9. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ ><br>10. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ ><br>11. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ ><br>12. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. <br/ ><br>13. Long-term use ( > 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed). <br/ ><br>14. Any history of hereditary angioedema or idiopathic angioedema. <br/ ><br>15. Any history of anaphylaxis in relation to vaccination. <br/ ><br>16. Any history of albumin-intolerance. <br/ ><br>17. Pregnancy, lactation, or willingness/intention to become pregnant during the study. <br/ ><br>18. History of any cancer. <br/ ><br>19. History of psychiatric severe conditions likely to affect participation in the study. <br/ ><br>20. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. <br/ ><br>21. Any other serious chronic illness requiring hospital specialist supervision. <br/ ><br>22. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild asthma. <br/ ><br>23. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness <br/ ><br>24. Morbidly obese (BMIâ?¥35 kg/m2) or underweight (BMI â?¤18 kg/m2). <br/ ><br>25. Living in the same household of any COVID-19 positive person. <br/ ><br>26. Any other condition that in the opinion of the investigator would jeopardize the safety or rights → | | Intervention1: BBV152B: Whole-Virion Inactivated SARS-CoV-2 vaccine (BBV152B) Dose: 0.5ml, Route of administration:Intramuscular injection<br>Control Intervention1: Placebo: Placebo will be used as a control. Dose: 0.5ml Route of administration:Intramuscular injection<br>→ | To evaluate the immunogenicity in terms of GMT and four fold seroconversion rate of neutralizing antibodies NAbs across the two groups Vaccine and PlaceboTimepoint: baseline, 28 days 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/04/032943 | 24 May 2021 | Study of physiological parameters in COVID-19 Disease | Retrospective Cohort Study of physiological parameters in COVID-19 Disease | | Dr Pallavi Yuvaraj Badhe | 19-04-2021 | 20210419 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54906 | Not Recruiting | No | | | | 02-06-2021 | 400 | Observational | Cluster Randomized Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Cluster Randomized Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Krishnakant Balasaheb Patil→ | | Dept of Physiology Symbiosis Medical College for Women, Lavale, Hill Base, Symbiosis International Deemed University Pune → | drkrishnakant_patil@rediffmail.com→ | 9689304497→ | Symbiosis Medical College for Women Lavale Pune→ | Inclusion criteria: Male and female COVID swab positive patients having age â?¥ 18 year→ | Exclusion criteria: Exclusion Criteria: <br/ ><br>Patients on drug affecting cardiac function( altering ECG waves) :Antiarrhythmic drugs: Disopyramide, Propafenone and flecainide, Amiodarone, Beta blockers, Digitalis, HCQ, Quinidine, Anthracycline Antibiotics- doxorubicin and daunorubicin <br/ ><br> <br/ ><br>Diagnosed chronic heart diseases: like Chronic ischemic changes, valvular disorder, cardiac hypertrophies, COPD, Congenital heart disease→ | Health Condition 1: A00-B99- Certain infectious and parasitic diseases
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Weather ECG within 1 day of hospital admission can be used as prognostic marker or not will be clear. There might be significant changes in physiological variables in COVID- 19 patients and when these changes will be analyzed statistically, we might get significant results, which may be helpful to clinicians to treat reversible cardiovascular complications.Timepoint: Data Collection 1 month <br/ ><br>Data Entry & Compilation 15 days <br/ ><br>Data Analysis 15 days <br/ ><br>Manuscript Preparation 1 month→ | | | | Yes | False | | |
| → | CTRI/2021/04/032952 | 24 May 2021 | Role of Kabasura Kudineer in managing Covid patients | Effectiveness of Kabasura Kudineer in Management of Asymptomatic, Mild to Moderate cases of COVID -19 : An Open Label, Single Blind, Pilot Randomized Controlled Trial | | Sri Sri tatva advanced research institute | 20-04-2021 | 20210420 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55118 | Not Recruiting | No | | | | 25-04-2021 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Outcome Assessor Blinded→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Outcome Assessor Blinded | Phase 3/ Phase 4 | India→ | Dr Meenakshi Khapre→ | | Department of Community and Family Medicine, Veerbhadra road , Rishikesh , Uttarakahnd → | drmeenaxi15@ymail.com→ | | AIIMS Rishikesh→ | Inclusion criteria: Age between 18 to 55 years, both male & female <br/ ><br>Asymptomatic, mild to moderate confirmed cases of covid19 infection as per GOI definition <br/ ><br>Reported to OPD within 3 days of onset of symptoms <br/ ><br>Willing to take ayush treatment→ | Exclusion criteria: patients not willing to give consent or participate in the clinical trial <br/ ><br>patients with co-morbidities like known case of hypertension , diabetes, heart diseases thyroid disorders,liver or renal diseases,moderate to severe anemia, blood related disorders etc <br/ ><br>Patients with associated co-morbidities like known case of hypertension, type 2 or type 1 diabetes or chronic or acute renal failure, thyroid disorder, respiratory diseases (asthama, copd ) renal diseases. <br/ ><br>Baseline investigation CBC, LFT, KFT, RBS shows abnormalities <br/ ><br>patients on immuno-suppressive therapy <br/ ><br>pregnant women or lactating mothers <br/ ><br>undergone major surgery in recent 6 months or hospitalized for more than 3 days for any condition.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Kabasura Kudineer: asymptomatic and mild cases: 2 tablet a day orally for period of 15 days as standalone <br>moderate case : 2 tablet a day orally for period of 15 days with standard therapy i.e comparator agent<br>Control Intervention1: paracetamol , vitamin C, methylprednisolone, remedesivir, enoxaparin and supportive treatment: Mild : PCM 500 mg sos and vitamin C od for 15 days , cough syrup tds for 5 days<br>Moderate : along with sympotomatic treatment, inj methylprednisolone 1-2 mg/kg in 2 divided dose for 5-110 days, inj remedesivir 200 mg IV on day 1 f/b 100 mg IV daily for 5 -10 days <br>low dose prophylactic enoxaparin 0.5 mg/kg per day SC<br>→ | a.Time needed for improvement and relief in sign and symptoms individually and term of Pandemic Respiratory Infection Emergency System Triage (PRIEST) score <br/ ><br>b.Variation in immunity markers ( IL6, CRP) <br/ ><br>c.Time needed for sero-conversion <br/ ><br>d.Duration and events during hospital / home stay <br/ ><br>e.Time for clinical recovery in terms of rtpcr and viral clearanceTimepoint: at baseline, 5 days, 10 days and 15 days , 21-28 days→ | | | | Yes | False | | |
| → | CTRI/2021/04/032976 | 24 May 2021 | HIV Selftesting Implementation Study
| Accelerating Access And Uptake Of HIV Self-Testing (HIVST) In India-
An Implementation Study
- HIVST DEMO_STUDY | | Population Services International | 20-04-2021 | 20210420 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50046 | Not Recruiting | No | | | | 01-06-2021 | 118440 | Interventional | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Alpana Dange→ | | 3rd Floor Manthan Plaza Near Vakola Masjid Nehru Road, Vakola, Santacruz (East) Mumbai Maharashtra Same as address 1→ | ahegde@path.org→ | 9821884134→ | PATH→ | Inclusion criteria: At risk population /regular sex/Injecting partners of at-risk population contacted through different service delivery models who are willing for HIVST, persons completed 18 years of age and Consenting to share their HIVST results→ | Exclusion criteria: Individuals who know their status as HIV positive will not be eligible for HIVST. <br/ ><br>→ | | Intervention1: Accelerating Access and Uptake of HIV Self-Testing in INDIA -An Implementation Study<br>: National AIDS Control Organization (NACO) has included HIV Self-Testing (HIVST) as a priority area for exploration in the National Strategic Plan 2017-2024 and has also formed a Technical Advisory Group (TAG) in 2017 to guide the launch of HIVST in India.<br><br>The overarching goal of the proposed implementation research is to demonstrate different HIVST service delivery models and generating evidence for HIVST policy in India. HIVST ensures covering the last mile for HIV testing services and reaching all. <br><br>This study aligns with one of the recommendations made by the third National HIVST TAG meeting in May 2019, which is to plan and conduct operational research/pilots on HIV self-screening. <br><br>The implementation research proposes different HIVST service delivery models to the â??at-riskâ?? population including key population and their sexual/injecting partners. It is proposed to utilize around 1.88 lakhs HIVST kits across the population and models. The saliva and blood based HIVST kits will be utilized in the implementation models and the participants will be provided an option to select the kit based on their willingness. <br><br>The duration of this implementation research is 12 months starting from the date of IRB approval. The study sites will be selected from Andhra Pradesh, Maharashtra, Tamil Nadu, Telangana, Delhi, Uttar Pradesh, Haryana, Punjab, West Bengal, Gujarat, Karnataka, Bihar, Rajasthan, Madhya Pradesh and Goa. The study implementation period is dependent on the Covid-19 lockdown related circumstances in India.<br><br>Intervention2: ACCELERATING ACCESS AND UPTAKE OF HIV SELF-TESTING (HIVST) IN INDIA -AN IMPLEMENTATION STUDY<br>: National AIDS Control Organization (NACO) ha→ | 1. Enabling to reach the unreached for HIV testing services. <br/ ><br>2. Standard operating procedures (SOP) for different HIVST service delivery models will be developed based on implementation experiences. <br/ ><br>Timepoint: During the project period→ | | | | Yes | False | | |
| → | CTRI/2021/04/032964 | 24 May 2021 | The impact of COVID-19 pandemic on cancer children
| The impact of COVID-19 pandemic on the care of children with cancer in a tertiary care
centre
| | Dr Latha MS | 20-04-2021 | 20210420 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54185 | Not Recruiting | No | | | | 03-05-2021 | 500 | Observational | Other
Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:→Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Latha M S→ | | Division of Pediatric Hematology and Oncology
Department of Pediatrics,
Sri Ramachandra Institute of Higher Education and Research
No.1, Ramachandra Nagar
Porur
Chennai
→ | drmslatha@yahoo.com→ | 09952579525→ | Sri Ramachandra Institute of Higher Education and Research→ | Inclusion criteria: all children with oncological diagnosis admitted during study period→ | Exclusion criteria: children admitted with non oncological diagnosis→ | Health Condition 1: C910- Acute lymphoblastic leukemia [ALL]
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | impact of covid pandemic on management of children with cancerTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/04/032965 | 24 May 2021 | Prevalence of asymptomatic COVID positivity in the pre-operative patient | Incidence of SARS-CoV2 infection among ASymptomaticpatients undergoing PrE-operative COVID Testing prior to cancer surgery - ASPECT study | | Tata Memorial Hospital | 20-04-2021 | 20210420 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55271 | Not Recruiting | No | | | | 30-04-2021 | 2200 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shraddha Patkar→ | | Department of Surgical oncology 3rd floor room number 328 homibhabha block tata memorial hopsital dr ernest borges marg parel mumbai → | drshraddhapatkar@gmail.com→ | 9820074818→ | Tata Memorial Centre→ | Inclusion criteria: All patients who underwent preoperative SARS-C0V-2 testing prior to cancer surgery (elective and emergency) <br/ ><br>→ | Exclusion criteria: symptomatic patients who planned to underwent preoperative SARS-C0V-2 testing prior to cancer surgery→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Percentage of asymptomatic infection among those patients undergoing routine preoperative testing before cancer surgery using RT-PCR of nasopharyngeal and oropharyngeal swabsTimepoint: 7 months→ | | | | Yes | False | | |
| → | CTRI/2021/04/033000 | 24 May 2021 | Correlation between RT-PCR Cycle Time(Ct values) and quantitative estimate of antibodies formed after COVID-19 infection in COVID-19 patients | Correlation between RT-PCR Cycle time(Ct values) and COVID serology titres in COVID-19 patients | | NIL | 22-04-2021 | 20210422 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55380 | Not Recruiting | No | | | | 30-04-2021 | 60 | Observational | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Rajat Gupta→ | | WD27, NMB, LNJP HOSPITAL, CENTRAL DELHI 110002 → | drsandeepgargmamc@gmail.com→ | 9958311466→ | Maulana Azad Medical College→ | Inclusion criteria: COVID POSITIVE PATIENTS→ | Exclusion criteria: NIL→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: NIL: NIL<br>→ | RT-PCR Ct values <br/ ><br>COVID Antibody titresTimepoint: RT-PCR Ct values at the day of admission <br/ ><br>COVID Antibody titres at the day of admission, day of discharge, 1 , 2 and 4 months after symptom onset→ | | | | Yes | False | | |
| → | CTRI/2021/04/033004 | 24 May 2021 | survey on regional anesthesia practice among anaesthesiologists | A prospective questionnaire-based survey to ascertain the effect of COVID-19 pandemic on regional anaesthesia practices amongst anaesthesiologists of India | | No funding needed | 22-04-2021 | 20210422 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55269 | Not Recruiting | No | | | | 26-04-2021 | 300 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Anju Gupta→ | | Department of Anesthesiology, Pain Medicine and Critical Care → | dranjugupta2009@rediffmail.com→ | 9911573371→ | Department of Anesthesiology, Pain Medicine and Critical Care, AIIMS, Delhi→ | Inclusion criteria: 1.Anaesthesiologists of any experience working in government, private, autonomous institution or as freelancer. <br/ ><br>2.Willing to participate in the study. <br/ ><br>→ | Exclusion criteria: participant refusal→ | | | Affect of COVID-19 on regional anaesthesia practice of anaesthesiologistsTimepoint: This is a survey and the opinion of the participants will be recorded at a single time point→ | | | | Yes | False | | |
| → | CTRI/2021/04/032989 | 24 May 2021 | A study to assess the safety and efficacy of "pHoxvedic", an ayurvedic nasal spray in prevention COVID-19 infection in healthy high-risk healthcare professionals
| A double blind, randomized, placebo-controlled study to assess the
efficacy and safety of an Ayurvedic nasal spray â?? pHoxvedicâ?? in the
prevention of SARS CoV-2 infection in high-risk healthcare
professionals. | | RAPHAEL LABS LTD | 22-04-2021 | 20210422 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55273 | Recruiting | No | | | | 27-04-2021 | 648 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Meena Dalal→ | | Room No: 1, 3rd floor, 467, 1st Main Rd, Royal County, 8th Phase, Gottigere, Bengaluru, Karnataka 560083 → | archana.kamath@trialguna.com→ | 9964666634→ | Trial Guna→ | Inclusion criteria: 1. Healthcare professionals at high risk of SARS-CoV-2 exposure. <br/ ><br>2. Normal or clinically insignificant findings during screening, medical <br/ ><br>history, medical examination, laboratory evaluations. <br/ ><br>3. Subjects agree to refrain from taking over the counter products <br/ ><br>intended to prevent, intervene in, or treat colds/flu, starting at study <br/ ><br>entry and continuing through out study. <br/ ><br>4. Able to give voluntary informed consent for participation in the study.→ | Exclusion criteria: 1. Laboratory confirmed SARS-CoV-2 positive. <br/ ><br>2. Laboratory confirmed IgG positive for SARS-CoV-2 <br/ ><br>3. Proven history of SARS-CoV-2 infection (laboratory confirmation by PCR <br/ ><br>testing). <br/ ><br>4. Previous participation in any clinical trial of a SARS-CoV-2 candidate <br/ ><br>vaccine. <br/ ><br>5. Subjects, who have been partially or fully vaccinated against SARS-CoV2 with any approved vaccine. <br/ ><br>6. History of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy. <br/ ><br>7. Subjects with confirmed immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy. <br/ ><br>8. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, hematological, psychiatric, or immunological disorder or any other <br/ ><br>symptoms or disorder that may interfere with study objectives as per Principal Investigator discretion. <br/ ><br>9. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration <br/ ><br>during the study. <br/ ><br>10. SARS-CoV-2 vaccine planned to be administered during the study <br/ ><br>period <br/ ><br>11. Pregnant and lactating women. <br/ ><br>12. Participation in another clinical trial in the past 3 months. <br/ ><br>13. History of drug / alcohol abuse. <br/ ><br>14. Unable to complete the daily symptom tracker. <br/ ><br>15. Unable/unwilling to follow local standard SARS-CoV-2 infection prevention measures e.g., PPE, face shield, masks etc. <br/ ><br>16. Any nasal/sinus anatomy that will make use of the nasal spray difficult <br/ ><br>or is symptomatic to the point where it will interfere with the study. <br/ ><br>→ | | Intervention1: Ayurvedic Nasal Spray- â??pHoxvedicâ??: Ayurvedic Nasal Spray refers as â??pHoxvedicâ?? is unique combination of rationally selected 6 salts and 4 <br>essential oils. pHoxvedic should be taken TID 140 ul/nostril for 45 days, with a gap of 6-8 hours <br>between doses.<br>Control Intervention1: Placebo: Ayurvedic Nasal Spray equivalent Placebo is composed of Sodium Chloride, Polyethylene glycol 400, Basil Delight 2010 and Sterile water. Placebo should be taken TID 140 ul/nostril for 45 days, with a gap of 6-8 hours <br>between doses.<br>→ | Percentage of subjects who test positive on rt-PCR for SARS-CoV-2Timepoint: Over 45 days of the study→ | | | | Yes | False | | |
| → | CTRI/2021/04/033047 | 24 May 2021 | Impact of markers like D-Dimer and Coagulation parameters in predicting outcome in COVID-19 patients | Prognostic role of D-Dimer and Coagulation parameters in hospitalized COVID-19 patients | | Kowshik V | 23-04-2021 | 20210423 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53102 | Not Recruiting | No | | | | 03-05-2021 | 400 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Kowshik V→ | | Department of General Medicine, Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra nagar, Porur, Chennai, Tamil Nadu - 600116 → | drebhaskar@gmail.com→ | 9840717971→ | Sri Ramachandra Institute of Higher Education and Research→ | Inclusion criteria: RT-PCR of nasopharyngeal or oropharyngeal swab confirmed COVID-19 patients more than or equal to 18 years of age and either gender hospitalized for the illness→ | Exclusion criteria: COVID-19 positive patients less than 18 years of age <br/ ><br> <br/ ><br>Patients on pre-hospitalization anti-coagulation <br/ ><br> <br/ ><br>Patients with cancer and prior thrombocytopenia or coagulopathy <br/ ><br> <br/ ><br>Patients having hospital stay less than 3 days→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Not applicable: Not applicable<br>Control Intervention1: Nil: Nil<br>→ | Clinical recovery of the patientTimepoint: At baseline at 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/04/033038 | 24 May 2021 | General publicâ??s perception of CoVid-19:Anxiety levels and
preventive measures | Assessment of general publicâ??s perception of CoVid-19:Anxiety levels and
preventive measures | | Central Research Facility SRIHER | 23-04-2021 | 20210423 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52346 | Not Recruiting | No | | | | 26-04-2021 | 384 | Observational | Other
Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shreya Thakur→ | | Sri Ramachandra Medical College and Research Institute
SRIHER (DU)
No 1, Ramachandra Nagar
Porur Chennai - 116 → | drsheelaravinder@sriramachandra.edu.in→ | 9884314437→ | Dept of Physiology, Sri Ramachandra Medical College RI→ | Inclusion criteria: Adult healthy volunteers willing to participate in the study→ | Exclusion criteria: Those who do not have internet connection <br/ ><br>Those who are unable to read / write→ | | | Monitor public perceptions and misconceptionsTimepoint: 1 month→ | | | | Yes | False | | |
| → | CTRI/2021/04/033068 | 24 May 2021 | Observational study to see how long the SARS CoV-2 virus remains alive in the nose and throat of cancer patients on chemotherapy | A Prospective observational study to establish the duration of persistence of replication-competent SARS-CoV-2 in oncology patients with COVID-19 on chemotherapy | | Tata Memorial Hospital | 23-04-2021 | 20210423 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55435 | Recruiting | No | | | | 01-05-2021 | 50 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Chetan Dhamne→ | | R. no. 1111, 11th floor, Homi Bhabha Block, Department of Medical Oncology-Pediatrics, Tata Memorial Hospital. Dr. Ernest Borges Road. Parel. Mumbai → | chetandhamne@gmail.com→ | | Tata Memorial Hospital→ | Inclusion criteria: 1. Oncology patients admitted with RT-PCR confirmed COVID-19 illness <br/ ><br>2. Age 1 to 80 years <br/ ><br>3. Patients willing to consent for additional blood and nasopharyngeal swabs. <br/ ><br>→ | Exclusion criteria: 1. ICU patients unable to give nasopharyngeal swab or blood sample for study proposes <br/ ><br>2. Patients with other inter-current bacterial viral respiratory infections. <br/ ><br>3. Patients in palliative therapy <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | Intervention1: Not applicable: Not applicable<br>Control Intervention1: Not applicable: Not applicable<br>→ | Determine the duration of persistence of replication-competent/infectious virus in oncology patients.Timepoint: At the baseline and at the time repeat nasopharyngeal swab if required as per standard reassessment→ | | | | Yes | False | | |
| → | CTRI/2021/04/033058 | 24 May 2021 | Effect of early mobility in patients with severe COVID-19 admitted in ICU | Effect of early mobility on functional status in patients with severe COVID-19, admitted to ICU | | Saravankumar J | 23-04-2021 | 20210423 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46761 | Recruiting | No | | | | 01-05-2021 | 140 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Outcome Assessor Blinded→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Saravankumar J→ | | 5th Floor,B5-cardiopulmonary physiotherapy dept,
Saveetha college of Physiotherapy,SIMATS,
Chennai 5th Floor,B5-cardiopulmonary physiotherapy dept,
Saveetha college of Physiotherapy,SIMATS,
Chennai→ | saravankumar.scpt@saveetha.com→ | 9962181542→ | Saveetha Institute of Medical & Technical Sciences→ | Inclusion criteria: accord with the clinical diagnosis and/ or etiological diagnosis diagnostic criteria of Novel coronavirus pneumonia (COVID-19) and admitted to ICU <br/ ><br>→ | Exclusion criteria: acute stroke, status epilepticus ,Coagulation disorders, Psychiatric disorders or severe agitation, Cardiorespiratory instability, Need for significant vasopressive support, rapidly developing neuromuscular disease, cardiopulmonary arrest, irreversible disorders with 6-month mortality estimated at more than 50%, raised intracranial pressure, absent limbs. <br/ ><br>Pre morbid functional status <14 in FSS-ICU <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Early Mobility: Structured protocol which includes bed mobiity, edge of bed sitting, transfer, out of bed sitting and ambulation<br>Control Intervention1: Usual care: Chest Physiotherapy includes deep breathing exercise, Chest percussion(if needed) and positioning.<br>→ | Functional status score ICUTimepoint: at ICU discharge→ | | | | Yes | False | | |
| → | CTRI/2021/04/033073 | 24 May 2021 | Using Homeopathic Combinations for the Treatment of Fever due to COVID19 and addressing the associated Respiratory distress. | Evaluating the Efficacy of Homeopathic Combinations for the Treatment of Fever due to COVID19 and its effect on addressing the associated Respiratory distress. | | Cancer Aid Society | 23-04-2021 | 20210423 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55218 | Not Recruiting | No | | | | 24-04-2021 | 50 | Interventional | Non-randomized, Active Controlled Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Piyush Gupta→ | | 4th Floor Sunshine Court 2,
66C Prag Narain Road, Lucknow 4th Floor Sunshine Court 2,
66C Prag Narain Road, Lucknow→ | dranurag11@gmail.com→ | 7388970385→ | Ram Manohar Lohia Institute of Medical Sciences→ | Inclusion criteria: COVID +VE PATIENTS <br/ ><br>Patients having Fever or Respiratory Distress or Both being treated at Ram Manohar Lohia Institute of Medical Sciences→ | Exclusion criteria: COVID -VE PATIENTS <br/ ><br>Patients with Comorbidities <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Using Homeopathic Combinations for the Treatment of Fever due to COVID19 and associated Respiratory distress, comparator not available: Arsenicum Album, Allium Cepa, Aconitum Napellus, Influenzinum, Gelsmium Sempervirens, Eupatorium Perfoliatum, Echinecia, Thuja Occidentalis, Senega, Aspidosperma quebracho, Arnica Montana, Crataegus oxyacantha, Chelidonium majus<br><br>Homeopathic Combinations X & Y with the beginning dose of 3 pills to be taken sublingually six times every 10 minutes, then six times every hour and finally six hourly for a week.<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | Treatment of fever and respiratory distress patients suffering from COVID19 infection.Timepoint: 1 Week→ | | | | Yes | False | | |
| → | CTRI/2021/04/033078 | 24 May 2021 | Does covid-19 infection lead to hearing loss? | Audiological assessment of post covid health care workers in a tertiary health care centre of Delhi | | CNBC | 24-04-2021 | 20210424 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53377 | Not Recruiting | No | | | | 24-04-2021 | 75 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrEkta Narang→ | | ENT OPD
Room No 134
CNBC
New Delhi ENT OPD
Room No 134
CNBC
New Delhi→ | chhabra.ekta@gmail.com→ | 8595919342→ | Chacha Nehru Bal Chikitsalya→ | Inclusion criteria: Health care workers tested positive for covid-19.→ | Exclusion criteria: Acute URI <br/ ><br>Patients with previous ear disease <br/ ><br>Patients who give history of previous hearing loss <br/ ><br>Any chronic illness (any disease which has lasted more than 3 months) <br/ ><br>→ | | Intervention1: not applicable: not applicable<br>→ | The number of patients who have hearing loss on pure tone audiometry testingTimepoint: baseline→ | | | | Yes | False | | |
| → | CTRI/2021/04/033108 | 24 May 2021 | Investigation about the problem in seeing area due to wearing of face mask during COVID-19 | To study the influence of face masks on visual field amid COVID-19 pandemic | | Manipal College of Health Professions | 26-04-2021 | 20210426 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54531 | Not Recruiting | No | | | | 20-05-2021 | 50 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Shonraj Ballae Ganeshrao→ | | Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education (MAHE), Manipal Udupi
→ | shonraj.bg@manipal.edu→ | 8886738267→ | Manipal Academy of Higher Education→ | Inclusion criteria: Normal Participant: <br/ ><br>Diagnosed healthy eyes <br/ ><br>Best Corrected Visual Acuity (BCVA) of 0.1 log MAR or better <br/ ><br>Refractive error between ±6.00 DS equivalent and cylindrical correction within ± 3.00 DC <br/ ><br> <br/ ><br>Diseased Participant: <br/ ><br>Diagnosed to have visual field defect <br/ ><br>Best Corrected Visual Acuity (BCVA) of 0.1 log MAR or better <br/ ><br>Refractive error between ±6.00 DS equivalent and cylindrical correction within ± 3.00 DC→ | Exclusion criteria: Normal Participant: <br/ ><br>Diagnosed healthy eyes <br/ ><br>Best Corrected Visual Acuity (BCVA) of 0.1 log MAR or better <br/ ><br>Refractive error between ±6.00 DS equivalent and cylindrical correction within ± 3.00 DC <br/ ><br> <br/ ><br> <br/ ><br>Diseased Participant: <br/ ><br>Nil→ | Health Condition 1: H409- Unspecified glaucoma
Health Condition 2: H534- Visual field defects
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | Difference in the measurement of the inferior visual field with and without maskTimepoint: At the end of the study→ | | | | Yes | False | | |
| → | CTRI/2021/04/033118 | 24 May 2021 | A clinical trial of Intravenous Aviptadil along with standard treatment in severe COVID-19 Patients with respiratory failure. | A multi-centric, comparative, randomized, double-blind, placebo-controlled, Phase 3 trial to evaluate the efficacy and safety of Intravenous Aviptadil, as an add-on to the â??Standard of Careâ?? in severe COVID-19 patients with respiratory failure. | | Zuventus Healthcare Limited | 26-04-2021 | 20210426 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53211 | Recruiting | No | | | | 30-04-2021 | 150 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Dr Bhupesh Dewan→ | | Department of Medical Services, 3101, C Wing, Oberoi Garden Estate, Chandivali, Andheri (E)
Mumbai → | Bhupesh.Dewan@zuventus.com→ | 022-30610000→ | Zuventus Healthcare Limited→ | Inclusion criteria: 1. Severe COVID-19 with respiratory failure <br/ ><br>2. Physician determination that patient is on maximal conventional medical therapy <br/ ><br>3. Without Mechanical ventilation or with mechanical ventilation < 7 days→ | Exclusion criteria: 1. Age <18 years <br/ ><br>2. Mechanical ventilation for more than 7 days. <br/ ><br>3. Mean Arterial Pressure < 65 mm Hg with use of pressor per ICU protocol <br/ ><br>4. Irreversible condition (other than COVID-19) with projected fatal course <br/ ><br>5. Requirement of Extracorporeal membrane oxygenation (ECMO) <br/ ><br>6. Current or recent (within 30 d) enrolment in another investigational trial of anti-IL6 drug; <br/ ><br>7. Active diagnosis of Acquired immune deficiency syndrome; <br/ ><br>8. Transplant patients currently immunosuppressed; <br/ ><br>9. Chemotherapy-induced neutropenia (granulocyte count <1000/mm3); <br/ ><br>10. Cardiogenic shock; congestive heart failure - NYHA Class 3 or 4; <br/ ><br>11. Recent myocardial infarction - within last 6 months and troponin > 0.5 <br/ ><br>12. Anuria (urine output < 50 ml/d) or other signs of multi-organ failure <br/ ><br>13. Severe liver disease with portal hypertension; <br/ ><br>14. Recent stroke or head trauma within last 12 months <br/ ><br>15. Increased intracranial pressure, or other serious neurologic disorder; <br/ ><br>16. Liquid diarrhea more than 3/day; defined as more than 3 non-bloody watery stools within a 24-hour period, requiring additional fluid and electrolyte supplementation <br/ ><br>17. Pregnant or lactating women→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Aviptadil 150mcg with<br>Standard of Care: Patients will be treated with 12-hour infusions of Aviptadil at ascending doses on 3 successive days. Patients will receive 0.166 mcg/kg/hr on Day 1, 0.332 mcg/kg/hr on Day 2 and 0.498 mcg/kg/hr on Day 3. The Standard of Care will be as per individual<br>Hospital protocol. It will be kept<br>as close to the government<br>treatment protocol as possible.<br>Control Intervention1: Placebo with Standard of Care: Placebo will be used as the control and will be administered 12-hour infusion 3 successive days. The Standard of Care will be as per individual Hospital protocol. It will be kept as close to the government treatment protocol as possible.<br>→ | Resolution of Respiratory FailureTimepoint: Day 0 through Day 28→ | | | | Yes | False | | |
| → | CTRI/2021/04/033175 | 24 May 2021 | PROVE Trial - Positive pRessure therapy in COVid-19 infEction
| A randomised controlled trial of oxygen delivery through nasal cannula or
NIP masks in patients with confirmed COVID 19 infection: The PROVE Trial - PROVE | | George Institute for Global Health India | 27-04-2021 | 20210427 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=44604 | Recruiting | No | | | | 30-04-2021 | 1800 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3 | India→ | Professor Vivekanand Jha→ | | 311-312, Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre→ | vjha@georgeinstitute.org.in→ | 911141588091→ | George Institute for Global Health→ | Inclusion criteria: 1. Age â?¥ 18 years <br/ ><br>2. Laboratory confirmed COVID-19 positive infection <br/ ><br>3. Requiring more than 40% oxygen (FiO2 > 0.4) â?? (requiring 6L or more of oxygen by Hudson mask <br/ ><br>or nasal cannula) to maintain SpO2 >93%→ | Exclusion criteria: 1. Obtunded <br/ ><br>2. The attending clinician is not committed to patient receiving mechanical ventilatory support <br/ ><br>3. In the opinion of the treating clinician the patient is in respiratory distress and is eminently <br/ ><br>requiring escalation of treatment including intubation and mechanical ventilation <br/ ><br>4. Currently receiving either CPAP, BiPAP, high flow nasal prongs or mechanical ventilation <br/ ><br>5. Participants usually on home ventilation (either CPAP or BiPAP) <br/ ><br>6. Previous participation in PROVE trial <br/ ><br>7. Known or suspected pregnancy <br/ ><br>8. Enrolment in the study is not in the best interest of the patient as deemed by the treating clinician→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Oxygen delivery via Materialise Passive Non-Invasive PEEP device mask<br>: Oxygen will be delivered via the Materialise Passive Non-Invasive PEEP device mask continuously through out the day or as tolerated by the patient. Oxygen should be delivered via the Materialise Passive NonInvasive PEEP device mask for a cumulative total of at least 2 hours per day.<br>Control Intervention1: Standard care oxygen delivery: Standard care oxygen delivery is defined as the delivery of oxygen via either nasal cannula (also referred to as nasal prongs) or simple face mask (such as Hudson mask). Oxygen delivery amounts will be titrated to a target SpO2 of 93% or greater.<br>→ | Need for escalation of respiratory support, defined as, need for CPAP, BIPAP, or <br/ ><br>invasive mechanical ventilationTimepoint: Upto 14 days following randomization→ | | | | Yes | False | | |
| → | CTRI/2021/04/033158 | 24 May 2021 | Low dose X-ray therapy for COVID-19 | Low Dose Radiotherapy using a portable X-ray unit for COVID-19 pneumonia- A Prospective Multicentric trial - COVID-X trial | | Harshamitra Superspecialty Cancer Centre and Research Institute | 27-04-2021 | 20210427 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55418 | Not Recruiting | No | | | | 17-05-2021 | 61 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 2 | India→ | Sasipriya P→ | | Harshamitra Oncology Private Limited, Room no.3, Level minus 1, Department of Radiation Oncology, Oncology Division, 101/4A, East Part, Mathur Road, Nagamangalam, Trichy-madurai highway, Trichy → | drsasipriyahmitra@gmail.com→ | 7373642777→ | Harshamitra Oncology Private Limited→ | Inclusion criteria: 1. Adult patients with RT-PCR proven COVID-19 with moderate to severe pneumonia with fewer than 14 days of symptom onset that warranted hospitalization and currently receiving standard medication for COVID-19 at appropriate doses which would include, among others, antivirals, corticosteroids, or anti-IL-6 tocilizumab and 2. moderate to severe dyspnoea, respiratory frequency equal to or greater than 30/min, oxygen saturation without supplemental O2 supply SpO2 94% or less, PaO2/FiO2 ratio or PaFiO2 ratio between 200 to 300 or SpO2/FiO2 ratio 315 or less if PaO2 is not available and/or 3. laboratory abnormalities such as C-reactive protein > 100 mg/L or D-dimer > 1000 ng/ml or IL-6 > 50 IU or suspected cytokine release syndrome (Criteria 1 and 2 are mandatory and 3 is optional)→ | Exclusion criteria: 1. Patients on ventilators (invasive/non-invasive) <br/ ><br>2. Prior lobectomy or pneumonectomy <br/ ><br>3. Prior thoracic radiotherapy resulting in a maximum lung dose of 100 cGy or higher within 14 days of enrollment <br/ ><br>4. Prior chemotherapy or other systemic therapy with potential for pulmonary toxicity or radio sensitization within 14 days or 5 half-lives, whichever is greater, of enrollment, e.g., bleomycin, gemcitabine <br/ ><br>5. Prior cancer immunotherapy with an immune checkpoint inhibitor within 60 days of enrollment <br/ ><br>6. Severe pre-existing heart disease, e.g., New York Heart Association (NYHA) functional class 3 (or higher) congestive heart failure <br/ ><br>7. History of bone marrow or solid organ transplantation <br/ ><br>8. Known history of autoimmune collagen vascular disease, e.g., scleroderma <br/ ><br>9. Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia <br/ ><br>10. Pregnancy <br/ ><br>11. Inability to be positioned supine and flat for radiation planning and delivery <br/ ><br>12. Inability to provide informed consent or lack of an authorized representative who can provide informed consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Low Dose Radiation therapy in addition to standard pharmacological therapy: Low dose radiotherapy using a portable X-ray machine to bilateral whole lungs as a single fraction treatment with a dose of 0.5 Gy in addition to pharmacological therapy based on guidelines devised by Ministry of Health and Family welfare, India Dexamethasone 6mg IV Once daily for 10 days, (Alternative: Methylprednisolone 80mg IV BD for 10 days) Enoxiparin 60mg s/c Once Daily for 5 days (dose adjusted based on D-dimer levels), Remdesvir 200mg IV Once daily on day 1 followed by 100mg IV Once daily for next 4 days, further continuance based on clinical response, Convalescent plasma One or two units (approximately 200-250ml per unit), Tocilizumab 400mg IV as a single dose (repeat dose in 12 to 24 hours if patientâ??s condition has not improved), Vitamin D 60,000U /week, Vitamin C 1500 mg/day, Zinc, Paracetamol, Anti-tussives, Antibiotics, Oxygen supplementation. Adjunctive therapies : IV thiamine,IV vitamin C, N acetyl cysteine, Ulinastatin, Sepsivac (mycobacterium w), high dose statins. Salvage therapies : Pulse therapy of steroids, Cytosorb-hemoperfusion, Pirfenidone,Alteplase. The pharmacologic therapy is individualized on a case by case basis<br>Control Intervention1: Standard Pharmacological Therapy only: Pharmacological therapy based on guidelines devised by Ministry of Health and Family welfare, India. Dexamethasone 6mg IV Once daily for 10 days (Alternative: Methylprednisolone 80mg IV BD for 10 days), Enoxiparin 60mg s/c Once Daily for 5 days (dose adjusted based on D-dimer levels), Remdesvir 200mg IV Once daily on day 1 followed by 100mg IV Once daily for next 4 days, further continuance based on clinical response, Convalescent plasma One or two units (approximately 200-250ml p→ | The primary end-point will be to evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in patients with COVID-19 by improving the PaO2-FiO2 by 20% measured 48-72h after treatment with respect to baseline pre-irradiation measurementTimepoint: 6 hours,day 1, day 2, day 3, day 4, day 7→ | | | | Yes | False | | |
| → | CTRI/2021/04/033143 | 24 May 2021 | Clinical trial on Covid 19 patients | A Multicenter Prospective, Open Label, Randomized, Clinical Study To Evaluate The Safety And Efficacy Of Cardamom-based capsules and sachets In Mild to Moderate Covid-19 Adult Patients | | Zum Heilen Diagnostic Therapeutics ZH DT | 27-04-2021 | 20210427 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55493 | Not Recruiting | No | | | | 03-05-2021 | 80 | Interventional | Non-randomized, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label→Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Dr Prashanth Varkey→ | | Zum Heilen Diagnostic and Therapeutics , No 143, Bethel LaneThrissur → | drpvarkey@gmail.com→ | 9249584682→ | Zum Heilen Diagnostic and Therapeutics→ | Inclusion criteria: 1. Subjects aged 18-75 years of age and of either sex <br/ ><br>2. Subjects who are willing to give consent to the study <br/ ><br>3. COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test (RT-PCR). <br/ ><br>4. Mild to Moderate disease (NEWS score Less than/equal to 8) <br/ ><br>5. Can take oral medicines <br/ ><br>6. Subject willing to abide by and comply with the study protocol <br/ ><br>→ | Exclusion criteria: 1. Age less than 18 years and more than 75 years <br/ ><br>2. Pregnancy and lactation <br/ ><br>3. Severe or complicated course of COVID-19 disease <br/ ><br>4. Presence of acute hypoxic respiratory failure/ need for Intensive care unit (ICU) stay/ Patients who need mechanical ventilation. <br/ ><br>5. Any uncontrolled systemic disease, infection <br/ ><br>6. Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or Renal disease or any other disorder. <br/ ><br>7. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Cardamom-based capsules containing Cardamom extract 200mg, Rosemary extract 200mg Pepper extract 10mg and total cineol content 97 mg: Dose : 500 mg <br>Dosage form : Capsules <br>Route of administration: Orally along with SOC<br>frequency: 3 times daily <br>Duration : 10 days<br>Intervention2: â?¢ Cardamom-based sachet contains Cardamom extract 200mg, Rosemary extract 200mg Pepper extract 10mg and total cineol content 97 mg: Dose : 500 mg Dosage form : Capsules Route of administration: Orally along with SOC frequency: 3 times daily<br>Duration : 10 days<br>Control Intervention1: standard of care released by government of India: As per the principal investigator advice <br>Duration : considering 10 days of the treatment<br>→ | 1. To assess the basal level inflammatory marker expression (IL-6, TNF-α, IL-10) by RT-PCR in SARS-CoV -19 patients prior to treatment administration. <br/ ><br>2.To asses the IL6,crp,D-DIMER and LDH <br/ ><br>3. To evaluate the effectiveness of cardamom-based capsules and sachets in treating SARS CoV-2 patients <br/ ><br>Timepoint: Day 0,Day 5 and Day 10→ | | | | Yes | False | | |
| → | CTRI/2021/04/033142 | 24 May 2021 | To see how Methylene blue drug which is used to increase O2 saturation levels, is helpful in treating Covid 19 patients. | An Observational pilot study to determine the effectiveness of Methylene Blue treatment in Covid 19 patients | | DR SMITHA K S | 27-04-2021 | 20210427 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55513 | Not Recruiting | No | | | | 03-05-2021 | 10 | Interventional | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | DR SMITHA K S→ | | Department of Anesthesia Bangalore Medical College and Research Institute Fort K R Road Bangalore → | smi9685@gmail.com→ | 9886935506→ | Bangalore Medical College and Research Institute.→ | Inclusion criteria: 1) Confirmed case of Covid 19 (RT-PCR) <br/ ><br>2) Admission to Intensive care unit <br/ ><br>3) Sex-Males and Females <br/ ><br>4) Age- 18 to 90 years old. <br/ ><br>5) Need for Oxygen support ( HFNC, NIV) <br/ ><br>6) Respiratory rate (RR) between 20 to 30 <br/ ><br>7) SpO2 between â?¤90 to 94 on room air. <br/ ><br>8) PaO2/FiO2 <200-300 <br/ ><br>9) Written informed consent→ | Exclusion criteria: Pregnancy and breastfeeding <br/ ><br>2) History of G6PD deficiency <br/ ><br>3) Severe renal insufficiency (GFR <30ml/min/1.73m2) <br/ ><br>4) Medical records of Cirrhosis <br/ ><br>5) Active or Chronic Hepatitis <br/ ><br>6) History of allergy to Methylene blue <br/ ><br>7) Patients on immunosuppressive agents. <br/ ><br>8) Patients exposed to aniline dyes and Dapsone→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Methylene blue injection: 1 mg/kg of Methylene blue injection given to covid 19 patients to treat Methemoglobinemia.<br>→ | To observe the effects of Methylene blue treatment in Covid 19 patients.Timepoint: 7 days→ | | | | Yes | False | | |
| → | CTRI/2021/04/033188 | 24 May 2021 | Clinical trial on Covid 19 patients | A Prospective, Open Label, Randomized, controlled Clinical Study to Evaluate the Safety and Efficacy Of Cardamom-based capsules and sachets In Mild to Moderate Covid-19 Adult Patients | | Zum Heilen Diagnostic and Therapeutics Pvt Ltd | 28-04-2021 | 20210428 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55568 | Not Recruiting | No | | | | 05-05-2021 | 120 | Interventional | Randomized, Parallel Group, Multiple Arm Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label→Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 3/ Phase 4 | India→ | Dr Prashanth Varkey→ | | Zum Heilen Diagnostic and Therapeutics Pvt. Ltd , No 143, Bethel
LaneThrissur
Thrissur
KERALA → | drpvarkey@gmail.com→ | 9249584682→ | Zum Heilen Diagnostic and Therapeutics Pvt. Ltd→ | Inclusion criteria: 1. Subjects aged 18-65 years of age and of either sex <br/ ><br>2. Subjects who are willing to give consent to the study <br/ ><br>3. COVID-19 positive clinical symptoms and (subsequently) confirmed by the <br/ ><br>current recommended confirmatory test (RT-PCR). <br/ ><br>4. Mild to Moderate disease (NEWS score Less than/equal to 8) <br/ ><br>5. Can take oral medicines <br/ ><br>6. Subject willing to abide by and comply with the study protocol→ | Exclusion criteria: Age less than 18 years and more than 65 years <br/ ><br>2. Pregnancy and lactation <br/ ><br>3. Severe or complicated course of COVID-19 disease <br/ ><br>4. Presence of acute hypoxic respiratory failure <br/ ><br>Any uncontrolled systemic disease, infection <br/ ><br>6. Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or <br/ ><br>Renal disease or any other disorder. <br/ ><br>7. Other conditions, which in the opinion of the investigators makes the patient <br/ ><br>unsuitable for enrolment or could interfere in adherence to of the study protocol <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Group 1: ICU patients <br>Cardamom-based Sachet containing Cardamom extract 200mg, Rosemary extract 200mg Pepper extract 10mg and total cineol content 97 mg: Dose : 500 mg Dosage form :<br>Capsules Route of<br>administration: Orally along with<br>SOC frequency: 4 times daily<br>Duration: 10 days<br>Intervention2: Group 2 : ICU patient Cardamom-based Sachet<br>containing Cardamom extract<br>200mg, Rosemary extract<br>200mg Pepper extract 10mg<br>and total cineol content 97 mg: Dose : 500 mg Dosage form :<br>sachet Route of<br>administration: Orally along with<br>SOC frequency: 4 times daily<br>Duration 10 days<br>Intervention3: Group 3 : Non ICU patients <br>Cardamom-based Sachet containing Cardamom extract 200mg, Rosemary extract 200mg Pepper extract 10mg and total cineol content 97 mg: Dose : 500 mg Dosage form : Sachet Route of administration: Orally along with SOC frequency: 3 times daily Duration: 10 days<br>Intervention4: Group 4 : Non ICU patients Cardamom-based Capsule containing Cardamom extract 200mg, Rosemary extract 200mg Pepper extract 10mg and total cineol content 97 mg: 500 mg Dosage form : Capsules Route of administration: Orally along with SOC frequency: 3 times daily Duration: 10 days<br>Control Intervention1: Group 5: ICU patients -Standard of care: As per Standard of care <br>recommended by principal investigator<br>Control Intervention2: Group 6: Non-ICU patients -Standard of care: As per Standard of care recommended by principal investigator<br>→ | 1. To assess the basal level inflammatory marker expression (CRP,D-Dimer,IL-6, TNF-α, IL-10) by RT-PCR <br/ ><br>in SARS-CoV -19 patients prior to treatment administration. <br/ ><br>2. To evaluate the effectiveness of cardamom-based capsules and sachets in treating SARS <br/ ><br>CoV-2 patientsTimepoint: Day 0,Day 5 and Day 10→ | | | | Yes | False | | |
| → | CTRI/2021/04/033201 | 24 May 2021 | Gayathri mantra chanting for the Stress and Quality Of Life in COVID 19 patients | Gayathri mantra chanting for the Alleviation Of Stress, Depression, Anxiety And Quality Of Life in COVID 19 patients: A Quasi experimental study | | R ARCHANA | 28-04-2021 | 20210428 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52520 | Not Recruiting | No | | | | 05-05-2021 | 60 | Interventional | Other
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | R ARCHANA→ | | DEPARTMENT OF PHYSIOLOGY, SAVEETHA MEDICAL COLLEGE AND HOSPITAL THANDALAM DEPARTMENT OF PHYSIOLOGY, SAVEETHA MEDICAL COLLEGE AND HOSPITAL THANDALAM→ | dr.rarchana@gmail.com→ | 09840608149→ | SAVEETHA MEDICAL COLLEGE AND HOSPITAL→ | Inclusion criteria: All willing Male and Female adult patients â?¥18 years and â?¤60 years of age at the time of recruitment→ | Exclusion criteria: Explicit non-willingness to be a part of the research study <br/ ><br>Patients with Severe Acute respiratory Distress syndrome and who were already practicing yoga or meditation <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: OM chanting: OM chanting repeatedly for 20 min along with the video recording of OM chanting twice a day (morning 6.00-8.00am and evening 4.00-6.00pm on empty stomach). The subject should inhale deeply through nose and while exhaling chant Ommm. Feel the vibration of â??mmmâ??. The mmmm part of Om should be long. During chanting, the eyes will be closed and to follow the traditional procedure of chanting it loudly for its best effect to invoke the innate power of intellect and relaxation.<br>Control Intervention1: NIL: NIL<br>→ | Data on whether GM intervention have any impact on reduction of symptoms, and reduction in mental stress, anxiety or depression in COVID 19 patients <br/ ><br>2. Preliminary results from this exploratory study may provide evidence for future confirmatory research studies. <br/ ><br>Timepoint: 3 months <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/04/033191 | 24 May 2021 | Study of COVID 19 in adults belonging to vulnerable age group | Spectrum of COVID 19 in non elderly adults | | Aparajit Ravikumar | 28-04-2021 | 20210428 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51618 | Not Recruiting | No | | | | 03-05-2021 | 1000 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Aparajit Ravikumar→ | | Department of General Medicine, No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116 → | drebhaskar@gmail.com→ | 9445954709→ | Sri Ramachandra Institute of Higher Education and Research→ | Inclusion criteria: RT PCR of Nasopharyngeal or Oropharyngeal swab confirmed COVID 19 patients aged between 18 - 59 years→ | Exclusion criteria: COVID 19 positive patients <18 years and >60 years, Suspected COVID 19 cases based on CT Thorax and Negative RT PCR result, Patients who get discharged at <48 hours of hospital stay, Patients who get discharged against medical advice→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Clinical recovery of the patientTimepoint: At baseline and 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/04/033193 | 24 May 2021 | Histopathological changes in placenta in COVID 19 mothers. | Study of placental histopathology in COVID 19 mothers at dedicated COVID 19 hospital in India. | | Dr Shilpa K lad | 28-04-2021 | 20210428 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55279 | Not Recruiting | No | | | | 10-05-2021 | 100 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Shilpa Kapil Lad→ | | Department of Pathology,
3rd floor,College Building ,
T N medical College and B Y L Nair ch Hospiatl ,Mumbai Central → | drshilpaklad@yahoo.com→ | 9820827567→ | T N Medical Colleg and B Y L Nair Ch hospital→ | Inclusion criteria: Placentas delivered of all Pregnant women with SARS COV2 infection (Positive on RT-PCR) will be included. All abortions and still births will be included <br/ ><br>→ | Exclusion criteria: Anemryogenic pregnancies will be excluded from the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: O43- Placental disorders
Health Condition 3: O00-O9A- Pregnancy, childbirth and the puerperium
→ | Control Intervention1: nil: nil<br>→ | Generate a comprehensive overview of SARS-CoV-2 infection, COVID 19 complications and changes seen in placenta.Timepoint: Data will be analysed at 3 monthly intervals→ | | | | Yes | False | | |
| → | CTRI/2021/04/033257 | 24 May 2021 | Effect of yoga on immunity in COVID positive patients | Evidence Based Validation of a Tele-Yoga Intervention in Positive Cases of COVID-19: A Controlled Pilot Study on Inflammatory Markers, T-cell Functions and Psychological States | | Department of Science and technology SATYAM division Government of India | 29-04-2021 | 20210429 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55549 | Not Recruiting | No | | | | 14-05-2021 | 60 | Interventional | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Lakshmi Nishitha J→ | | Department of Integrative Medicine, NIMHANS, Hosur Mainroad, Bengaluru → | nishitha.jasti910@gmail.com→ | | National Institute of Mental Health and Neurosciences→ | Inclusion criteria: 1. COVID 19 positive case diagnosed using PCR in authorized Covid19 testing facility <br/ ><br>2. Subjects who are asymptomatic or mild to moderately symptomatic [(cases presenting with fever or upper respiratory tract infection or pneumonia with - respiratory rate equal to or below 30 min; SpO2 equal to or above 90%) as per the clinical guidelines issued by Ministry of Health and Family Welfare] <br/ ><br>3. Aged 18-60 years <br/ ><br>4. Both genders <br/ ><br>5. Individuals with or without Diabetes and Hypertension (under control) <br/ ><br>6. High school education <br/ ><br>7. Willing to give a written consent to participate in the study <br/ ><br>→ | Exclusion criteria: 1.Severe infection requiring admission to ICU and other severe cases of COVID-19[(cases presenting with severe pneumonia with respiratory rate >30/min; SpO2 <90% or Acute Respiratory Distress Syndrome or septic shock as per the clinical guidelines issued by Ministry of Health and Family Welfare]. <br/ ><br>2.Any other comorbidity that prevents practice of Tele-Yoga program <br/ ><br>3.Clinical signs suggestive of multi-organ dysfunction. <br/ ><br>4.Score of less than 24 points on the Hindi Mental State Examination. <br/ ><br>5.Individuals with suicidal tendencies and psychosis <br/ ><br>6.Existing immunodeficiency or malignant disease <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tele yoga program for COVID-19: Tele-yoga program consists of physical postures and breath techniques that have been found beneficial in improving lung functions, immunity and reducing fatigue. Tele yoga program is 60-minute program that will be given for 5 days/week for 6 weeks<br>Control Intervention1: Treatment as usual: Treatment as usual prescribed by Ministry of health and family welfare to treat COVID-19 patients will be followed<br>→ | To test the validity and feasibility of developed Tele-Yoga intervention in COVID-19 positive patients. <br/ ><br>2.To examine the effects of the validated Tele-Yoga Program (TYP) on inflammatory markers (IL-6, TNF-α, and IFN-γ Inducible Protein-10) in individuals tested positive for COVID-19 <br/ ><br>Timepoint: baseline and 6 weeks after intervention→ | | | | Yes | False | | |
| → | CTRI/2021/04/033263 | 24 May 2021 | A comparison of high dose steroid and tocilizumab in COVID ARDS | Efficacy of High dose Dexamethasone Versus Tocilizumab in Patients With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: A prospective, randomized controlled trial | | Post Graduate Institute of Medical Education and Research | 30-04-2021 | 20210430 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55585 | Not Recruiting | No | | | | 06-05-2021 | 42 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Naveen Naik B→ | | Department of Anaesthesia and Intensive Care, fourth floor, Nehru Hospital, PGIMER, Chandigarh → | navin.amc123@gmail.com→ | 8872377925→ | Post Graduate Institute Of Medical Education And Research→ | Inclusion criteria: 1. Patients aged 18 years or above of either gender <br/ ><br>2. Confirmed SARS-CoV-2 (COVID-19) infection by RT-PCR with PaO2:FIO2 ratio of less than 200 on admission <br/ ><br>3. Use of one of the following for hypoxia: <br/ ><br>a. Oxygen supplementation with an oxygen flow of at least 10 L/min independent of delivery system <br/ ><br>b. Non-invasive ventilation or HFNC OR <br/ ><br>c. Invasive mechanical ventilation <br/ ><br>4. Within 48 hrs of initiation of standard therapy if <br/ ><br>a. PaO2:FIO2 ratio worsens by more than 50 from baseline value and <br/ ><br>b. Oxygenation or ventilation device is upgraded and <br/ ><br>c. Increasing or static CRP <br/ ><br>5. Imaging with chest X-ray/CT-Chest suggestive of COVID 19 related lung opacities. <br/ ><br>6. Signature of informed consent by the patient, family member or legal representative <br/ ><br>→ | Exclusion criteria: 1. known history of dexamethasone or Tocilizumab allergy <br/ ><br>2. Prior history of immunosuppression and use of immunosuppressive drugs <br/ ><br>3. Use of corticosteroids for indications other than COVID-19 <br/ ><br>4. Invasive fungal infection <br/ ><br>5. Active tuberculosis <br/ ><br>6. Liver injury or failure (AST/ALT â?¥ 5x Upper limit of normal) <br/ ><br>7. Leukocytes < 2 Ã? 103/μl <br/ ><br>8. Thrombocytes < 50 Ã? 103/μl <br/ ><br>9. Severe bacterial infection (Procalcitonin > 3ng/ml) <br/ ><br>10. Acute or chronic diverticulitis <br/ ><br>11. unwilling or unable to participate or complete the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: INTRAVENOUS HIGH DOSE DEXAMETHASONE (20MG): Following admission in the COVID ICU, standard treatment according to the COVID management institutional protocol will be done. If there is deterioration or worsening of the patient status, block randomisation will be done and accordingly high dose dexamethasone (20mg) will be administered for 3 days. This will be followed by the regular institutional protocol of 6mg dexamethasone once a day.<br>Intervention2: Tocilizumab 400mg: Following admission in the COVID ICU, standard treatment according to the COVID management institutional protocol will be done. If there is deterioration or worsening of the patient status, block randomisation will be done and accordingly injection tociliziumab (6mg/kg) maximum of 480mg will be administered.A single repeat dose may be considered if there is no improvement or clinical worsening in next 24 hours. This will be in addition to the regular 6mg dexamethasone as per institutional protocol.<br>Control Intervention1: Not applicable: Not applicable<br>→ | Ventilator free days (VFD) Timepoint: 0-28days following admission → | | | | Yes | False | | |
| → | CTRI/2021/04/033264 | 24 May 2021 | Effect of OM chanting on management Of Stress and Quality Of Life in COVID 19 Patients | Effect of OM chanting on management Of Stress, Depression, Anxiety And Quality Of Life in COVID 19 Patients â?? A Qualitative study | | R ARCHANA | 30-04-2021 | 20210430 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51322 | Not Recruiting | No | | | | 28-05-2021 | 60 | Interventional | Other
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | R Archana→ | | Department of Physiology, Saveetha Medical College and Hospital, Thandalam
602105
Department of Physiology, Saveetha Medical College and Hospital, Thandalam
602105
→ | dr.rarchana@gmail.com→ | 09840608149→ | Saveetha Medical College and Hospital→ | Inclusion criteria: All willing Male and Female adult patients â?¥19 years and â?¤60 years of age at the time of recruitment→ | Exclusion criteria: Explicit non-willingness to be a part of the research study <br/ ><br>Patients with Severe Acute respiratory Distress syndrome and not able to follow the OM chant <br/ ><br>Patients who were already practicing yoga or meditation <br/ ><br>→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: OM chanting: The Continuous AUM chanting for 20mins along with the video recording, twice a day between 6.00-8.00am in the morning and between 4.00-6.00pm in the evening on empty stomach for 14 days. <br><br>Control Intervention1: Not applicable: Not applicable<br>→ | Practice of OM chanting will be effective in reducing stress, anxiety, depression and improving the quality of life and quality of sleep in asymptomatic COVID 19 patients in the home care system.Timepoint: 16 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/04/033260 | 24 May 2021 | Pranayama and meditation to decrease COVID-19 related anxiety | Effect of Pranayama and Meditation on anxiety level of frontline health care workers dealing with COVID-19 patients | | Nil | 30-04-2021 | 20210430 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54998 | Not Recruiting | No | | | | 30-04-2021 | 45 | Interventional | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Viral Trivedi→ | | Room No 424
IKDRC-ITS
Civil hospital campus asarva
Ahmedabad → | vrltri@gmail.com→ | | IKDRC-ITS→ | Inclusion criteria: Anesthesia resident doctors who are working in the COVID 19 division of the hospital included in the study.→ | Exclusion criteria: Participants who were practicing pranayama and meditation or any form of relaxation yogic technique were excluded from the study.→ | | Intervention1: Pranayama and Meditation: & days online training of 4 techniques of pranayama and meditation<br>Duration 30 mins per day for 7 days<br>Control Intervention1: Pranayama and Meditation: 7 days online training of 4 techniques of pranayama and meditation<br>→ | Reduction in anxiety and stress level of health care professionalsTimepoint: with 7 days intervention based practice of pranayama and meditation <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/05/033327 | 24 May 2021 | A study to predict which parameters of patients with COVID19 admitted in ICU determine the prognosis | Developing a scoring system to predict the outcome of patients with COVID19 admitted in COVID ICU | | SRM Medical College Hospital | 03-05-2021 | 20210503 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47913 | Not Recruiting | No | | | | 27-05-2021 | 50 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Gayathri→ | | Department of Anaesthesiology 2nd floor, room No 209
Srm Medical College Hospital
Potheri
chengalpattu
TAMIL NADU
603203
India Department of Anaesthesiology 2nd floor, room No 209
Srm Medical College Hospital
Potheri
chengalpattu
TAMIL NADU
603203
India→ | gayathrii.r@gmail.com→ | 9500092905→ | srm Medical College Hospital and Research Centre→ | Inclusion criteria: Patients with covid pneumonia with spo2 <94% on oxygen support admitted in ICU. <br/ ><br>→ | Exclusion criteria: Age below 18years <br/ ><br>pregnant and breast feeding females→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | to predict the parameters which determine the outcome of seriously ill covid patients in terms of mortalityTimepoint: 1 month→ | | | | Yes | False | | |
| → | CTRI/2021/05/033301 | 24 May 2021 | Study to evaluate â??AyurCoro3 ( Ayurvedic Preparation )â?? in covid-19 treatment. | Prospective, multi center, observational, study on evaluation of use of, â??AyurCoro3â?? as an adjuvant for the treatment purpose in mild to moderate COVID-19 patients at tertiary care center. - Ayurcoro-3 Extension | | Shri Sarveshwar Seva Sahkari Samstha | 03-05-2021 | 20210503 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55614 | Not Recruiting | No | | | | 07-05-2021 | 184 | Observational | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Outcome Assessor Blinded→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | Dr Vijaykumar Gawali→ | | Medical Research Dept, Bhaktivedanta Hospital and Research Institute, srishti sector 1 ,
Bhaktivedanta Swami Marg, Mira Road ) East ) ,Thane → | drvijaykumar@bhaktivedantahospital.com→ | 9320199122→ | Consultant at Bhaktivedanta Hospital and Research Institute→ | Inclusion criteria: 1. Laboratory confirmed diagnosis of Mild to Moderate COVID-19 patients <br/ ><br>2. Patients in whom Ayurcoro-3 (as a adjuvant to the standard of care for mild to moderate covid-19) is prescribed by treating doctor. <br/ ><br>3. All Age groups above 18 Years <br/ ><br>4. All genders. <br/ ><br>→ | Exclusion criteria: 1. Patients on ventilator <br/ ><br>2. Critically ill patient <br/ ><br>3. Severe covid-19 patients (Dyspnea, respiratory frequency â?¥ 30/min, Blood oxygen saturation (SpO2) â?¤ 90%, PaO2/FiO2 ratio < 300, and/or lung infiltrates > 50% within 24 to 48 hours) <br/ ><br>4. Patients not willing to consent for the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Time (Days) to clinical improvementTimepoint: At Discharge→ | | | | Yes | False | | |
| → | CTRI/2021/05/033303 | 24 May 2021 | A study to assess the impact of guided meditation on anxiety, coping strategy and sleep quality among COVID-19 patients admitted in AIIMS, New Delhi. | A randomized controlled trial to assess the impact of guided meditation on anxiety, coping strategy and sleep quality among COVID-19 patients admitted in AIIMS, New Delhi. | | Nil | 03-05-2021 | 20210503 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48255 | Not Recruiting | No | | | | 05-05-2021 | 60 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable | N/A | India→ | Ms Suman→ | | Ms. Suman
Tutor
Room No-4,College of Nursing
AIIMS, New Delhi
→ | devanshi.chowdhary95@gmail.com→ | 8219409501→ | AIIMS, New Delhi→ | Inclusion criteria: 1. Hemodynamically stable. <br/ ><br>2. Willing to participate. <br/ ><br>3. Able to use cell phone. <br/ ><br>4. Having hospitalization for minimum 5 days <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Already diagnosed with psychiatric disease.→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: guided meditation: Intervention will be given in the form of audio guided meditation by using ear phone and mobile phone to the experimental group.<br><br> Guided meditation will be given twice/day for consecutive 5 days.<br><br><br>Intervention2: Experimental group: Intervention will be given in the form of audio guided meditation by using ear phone and mobile phone to the experimental group. Guided meditation will be given twice/day for consecutive 5 days.<br>Control Intervention1: control group: control group will get the standard routine care in the ward<br>Control Intervention2: Control group: <br><br>Control group will receive standard routine care in the ward after hospitalization in ward.<br>Control Intervention3: Control group: Control group will receive standard routine care in the ward after hospitalization in ward.<br>→ | 1. Anxiety, depression, coping strategy and sleep qualityTimepoint: Before and after intervention. Intervention was provided for 5 days. After 5 day post test was be taken.→ | | 10/04/2021 | | Yes | False | | |
| → | CTRI/2021/05/033339 | 24 May 2021 | To evaluate the efficacy of BIOWIN/BIOWN in asymptomatic mild Covid-19 patients. | A randomized, single centric, single arm, open label study to evaluate the efficacy and safety combination of BIOWIN and BIOWN in Covid-19 patients. | | Biogreen Remedies Private Limited | 04-05-2021 | 20210504 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55649 | Not Recruiting | No | | | | 09-05-2021 | 50 | Interventional | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | Phase 3 | India→ | Dr K Naresh Chandra→ | | Apeejay Business Center, Tresorie, Suite No-10, The Park, 22 Rajbhavan Road, Somajiguda, Hyderabad
→ | vveda14@gmail.com→ | 9704872737→ | Biogreen Remedies Private Limited→ | Inclusion criteria: 1. Ability to provide written and or e-consent (signed informed consent / consent given through Text message,WhatsApp or e-Mail are accepted (ICMR Guideline). <br/ ><br>2. Participants of either gender of age between â?¥18 to â?¤60 years <br/ ><br>3. Subjects able to communicate effectively <br/ ><br>4. Documented COVID-19 infection observed by positive RTPCR for SARS-CoV-2 on the day of screening <br/ ><br>5. Adults having an asymptomatic mild form of COVID-19 infection. <br/ ><br>6. Expressed interest and availability to fulfill the study requirements. <br/ ><br>7. Good general health as determined by the discretion of investigator (vital signs (heart rate â?¥60 toâ?¤100 bpm; blood pressure systolic â?¥80 mm Hg and â?¤180 mm Hg; diastolic â?¥ 50 mm Hg and â?¤100 mm Hg), medical history,and physical examination). <br/ ><br>8. For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until the end of study. <br/ ><br>9. Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner till the end of study. <br/ ><br>10. Ability to schedule and attend visits for the duration of the study. <br/ ><br>11. In the judgment of the Principal Investigator, able to comply with protocol requirements.→ | Exclusion criteria: 1. Contraindications or Hypersensitivity to study product. <br/ ><br>2. History or presence of any medical condition or disease according to the discretion of the Investigator. <br/ ><br>3. Subjects having history of asthma. <br/ ><br>4. Subjects having history of cardiovascular diseases. <br/ ><br>5. Subjects having history of diabetes (Type I or Type II) except other than the subject having the pre-diabetes condition with the fasting blood glucose between 100 to 125 mg/dl or random blood glucose > 140-199 mg/dl. <br/ ><br>6. Subjects having BP above 180/100 or below 80/50 mmHg <br/ ><br>7. Subjects having hyperthyroid/ hypothyroid disease. <br/ ><br>8. Subjects with HIV Positive. <br/ ><br>9. Subjects having history of high alcohol intake (2 standard drinks per day). <br/ ><br>10. Subjects having history of psychiatric disorder that may impair the ability of subjects to provide written informed consent. <br/ ><br>11. Any other condition that, in the opinion of the investigator, would adversely affect the subjectâ??s ability to complete the study or its measures. <br/ ><br>12. Subjects participated in any clinical study within thirty (30) days prior to screening. <br/ ><br>13. Patients suffering from ARDS in Covid 19 disease.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Intervention2: Biowin Capsules and Biown oral liquid solution: The daily dose of BIOWIN is 3 capsules per day for 7 days and BIOWN 8 ml of liquid is given once daily for 7 days<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>Control Intervention2: Standard of Care: Patients on Standard of care medicines who do not agree to take the Biowin and Biown.<br>→ | 1. Treatment satisfaction score <br/ ><br>2. Treatment Preference <br/ ><br>3. Quality of life scores <br/ ><br>4. Clinical and biochemical markers of RTPCR in covid testsTimepoint: 7 - 14 days→ | | | | Yes | False | | |
| → | CTRI/2021/05/033373 | 24 May 2021 | Study of correlation between the clinical, immunological and radiological features in mild and moderate COVID-19 patients | Assessment of clinico-immunological and radiological profile of mild and moderate COVID-19 patients | | Maulana Azad Medical College | 04-05-2021 | 20210504 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55705 | Not Recruiting | No | | | | 10-05-2021 | 50 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sricharan V→ | | Department of Medicine, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi → | drsandeepgargmamc@gmail.com→ | 9968604280→ | Maulana Azad Medical College→ | Inclusion criteria: COVID-19 positive patients with oxygen saturation (SpO2) > 90% on room air→ | Exclusion criteria: 1. COVID-19 positive patients admitted in ICUs. <br/ ><br>2. COVID-19 positive patients with shock/ARDS/MODS→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To assess the clinical, immunological and radiological profile of mild and moderate COVID-19 patientsTimepoint: Less than or equal to 9 months→ | | | | Yes | False | | |
| → | CTRI/2021/05/033338 | 24 May 2021 | A new device to detect COVID-19 in 2 minutes | A Pivotal Multicentric Single Blinded Case-Control Study to Evaluate clinical sensitivity and specificity of PELICAN COVID-19 ULTRA-RAPID MOBILE TEST in COVID-19 Positive Patients and Healthy Subjects using Saliva samples
| | Canary Global Inc | 04-05-2021 | 20210504 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54722 | Not Recruiting | No | | | | 24-05-2021 | 250 | Observational | Non-randomized, Multiple Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Outcome Assessor Blinded→Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Dr Hashmi Farogh→ | | Pragathi Mahalakshmi Building,
Clinical Research Division
4th Floor No. 62, Industrial Sabar, Yeshwantpur 2nd stage. → | sheth10687@gmail.com→ | | BreathX Technologies Pvt. Ltd., a Canary Global Inc. Company.→ | Inclusion criteria: 1 Male or female more than 2 years of age at Visit 1 or at the time of first sample collection for test in pre-screening or screening <br/ ><br>2 Participant is willing and able to give informed consent for participation in the study <br/ ><br>3 Subject who is able to comply with the study requirements, as defined in the present protocol, at the Investigatorâ??s discretion <br/ ><br>4 Is able to mentally and physically perform self collection of saliva using the provided collection device <br/ ><br>5 Written and well documented informed choice consent (and assent when applicable) obtained from subject and or subjectâ??s legal representative→ | Exclusion criteria: 1Male or female â?¤ 2 years of age at Visit 1 or at the time of first sample collection before enrolment. <br/ ><br>2Subject who has administered COVID-19 vaccines in last 12 months. <br/ ><br>3Flu shot within 6-8 weeks of test. <br/ ><br>4Any serious injury or illness likely to preclude completion of the trial. <br/ ><br>5Frequent alcohol or recreational drug use. <br/ ><br>6Undergoing active chemotherapy. <br/ ><br>7Inability to give informed consent and/or has no guardian. <br/ ><br>8Subjects with salivary gland dysfunction including subjects with Sjogren syndrome. <br/ ><br>9Subjects with oral cancers or any oral infections. <br/ ><br>10Subjects chewing tobacco, gutka, pan-masala, pan etc. <br/ ><br>11Subjects with mouth ulcer or any oral / dental infection which can impact the quality of saliva sample. <br/ ><br>12Subjects currently undergoing any dental surgery or procedure.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | The primary objective is to evaluate the performance, accuracy, clinical sensitivity and specificity of Pelican COVID-19 Ultra-Rapid Mobile test device to detect the SARS-CoV-2 infection of both symptomatic and asymptomatic COVID-19 infected and healthy subjects by collecting saliva samples.Timepoint: Screening up to 2 days, test procedure upto 6 days and follow up 10-14 days→ | | | | Yes | False | | |
| → | CTRI/2021/05/033374 | 24 May 2021 | Yoga based stress reduction program for health care professionals | Development and Validation of an Integrated Yoga Based Stress Reduction Program (IYBSR) for Health Care Professionals working in the context of COVID-19 - IYBSR | | Science and Technology for Yoga and Meditation SATYAM | 04-05-2021 | 20210504 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55771 | Not Recruiting | No | | | | 25-05-2021 | 188 | Interventional | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Manjula M→ | | Department of Clinical Psychology, NIMHANS, Bangalore - 29 → | drmanjula71@gmail.com→ | 09632603597→ | National Institute of Mental Health and Neuro Sciences (NIMHANS)→ | Inclusion criteria: Inclusion criteria for the health care professional: <br/ ><br>â?¢ Health care professionals involved in providing care for COVID-19 patients (screening, treatment and quarantine) <br/ ><br>â?¢ Adults in the age range of 18-60 years <br/ ><br>â?¢ Knowledge of English and the local language Kannada <br/ ><br>â?¢ Both genders <br/ ><br>Inclusion for experts: <br/ ><br>â?¢ Mental health professionals with experience of working in the mental health set up of more than 10 years <br/ ><br>â?¢ Yoga practitioners with experience of a minimum of 5 years of working in health care settings as consultants/faculty <br/ ><br>â?¢ Both genders <br/ ><br>â?¢ Age range of 35-65 years <br/ ><br>Inclusion for the control group: <br/ ><br>â?¢ Health care professionals not involved in caring in CVOID-19 <br/ ><br>â?¢ Screened below the cut off on K10 (psychological distress) <br/ ><br> <br/ ><br>→ | Exclusion criteria: Exclusion of health care professionals for the feasibility study <br/ ><br>1. Professionals who have major medical conditions/psychiatric conditions which will interfere with the practice of therapeutic techniques <br/ ><br>→ | | Intervention1: Integrated yoga based stress reduction program: The intervention to be developed will have components such as psychoeducation on stress and factors contributing to stress, a brief yoga module, self-care methods, managing stress (managing emotions, thoughts, healthy coping methods), seeking and enhancing social support etc. <br>Intervention will be carried out over 4-5 sessions on a tele-mental health mode over 4-5 weeks. <br>The intervention components will be developed and finalised based on the findings of first phase of the study.<br>Control Intervention1: NIL: NIL<br>→ | 1. A checklist/questionnaire to assess stress and felt needs of health professionals <br/ ><br>2. An idntegrated yoga-based stress reduction intervention (IYBSR) for future use with HCPs <br/ ><br>3. A user manual on IYBSR and a self-help mobile app of the intervention (the app would require further validation). <br/ ><br>Timepoint: 1 year→ | | | | Yes | False | | |
| → | CTRI/2021/05/033402 | 24 May 2021 | Surviving Covid 19 and Beyond | Surviving Covid 19 and Beyond | | Nil | 05-05-2021 | 20210505 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55460 | Not Recruiting | No | | | | 16-05-2021 | 20 | Interventional | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Swati Paranjape→ | | 402 Physiotherapy Department, Dhurmal Bajaj Orthopaedic Center, Opposite Tata Hospital E Borges Road, Parel, Mumbai 400012 402 Physiotherapy Department, Dhurmal Bajaj Orthopaedic Center, Opposite Tata Hospital E Borges Road, Parel, Mumbai 400012→ | swati.paranjape@kem.edu→ | 02224107000→ | Physiotherapy Department, Seth G S Medical College→ | Inclusion criteria: 1.Patients admitted at the tertiary care hospital with positive RT-PCR report. having mild to moderate clinical spectrum of SARS-CoV-2.Patients having mild clinical spectrum of SARS-CoV-2. (Patients having symptoms of covid-19 such as fever, cough, sore throat, malaise, headache, diarrhoea, loss of smell but not shortness of breath) <br/ ><br>3. Patients having moderate clinical spectrum of SARS-CoV-2. (Patients having symptoms of covid-19 who have SpO2 more than or equal to 94% on room air) <br/ ><br>→ | Exclusion criteria: 1.Patients having severe clinical spectrum of SARS-CoV-2. (Patients having symptoms of covid-19 who have SpO2 less than 94% on room air, ratio of PaO2/FiO2 <300mmHg) <br/ ><br>2.Patients having critical clinical spectrum of SARS-CoV-2. (Patients with respiratory failure, septic shock/ multiple organ dysfunction) <br/ ><br>3.Patients who are unable to respond to oral commands <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: WHO QOL BREF Questionnaire and Interview: Patients diagnosed with Covid 19 with mild to moderate condition and admitted at study site will be asked to fill the WHO QOL questionnaire. Post discharge after 2 months they will be asked to fill the questionnaire again and will be telephonically interviewed about their perceptions and own mental process about surviving Covid<br>Control Intervention1: Not applicable: Not Applicable<br>→ | 1.Quantitative Variable- WHO Quality Of Life BREF Questionnaire <br/ ><br>2.Qualitative Construct- Telephonic Interviews <br/ ><br>Timepoint: 1. Baseline (at the time of hospital admission) <br/ ><br>2. Two Months post discharge→ | | | | Yes | False | | |
| → | CTRI/2021/05/033409 | 24 May 2021 | A CLINICAL STUDY ON OUTCOME OFTRACHEOSTOMIES IN COVID 19 PATIENTS | TRACHEOSTOMIES IN COVID 19 era- experience at a tertiary care center in south India | | Dr Kavitha chendhilkumar | 06-05-2021 | 20210506 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54271 | Not Recruiting | No | | | | 07-05-2021 | 30 | Observational | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Kavithachendhilkumar→ | | C4 ICU,Sri Ramachandra Medical college and Research Institute.
No 1 Ramachandra Nagar
porur.Chennai
Chennai → | kavithachendhilkumar@sriramachandra.edu.in→ | 9962156015→ | Sri Ramachandra Medical College And Rresearch Institute→ | Inclusion criteria: a. Hemodynamically stable patients with positive expected survival outcome <br/ ><br>after discussion with the intensivist /treating physician. <br/ ><br>b. Stable ventilatory status <br/ ><br>c. Tube block, reintubation, <br/ ><br>d. Multiple failed extubation /reintubation attempts <br/ ><br>e. Failed reintubation are various issues associated with prolonged intubation <br/ ><br>and makes management with endotracheal tube by the ICU team difficult <br/ ><br>which warrants the need for tracheostomy <br/ ><br>f. 14 days from symptom onset/ 10 days post intubation <br/ ><br>g. Prone positioning - avoided <br/ ><br>h. Positive survival outcome <br/ ><br>i. Preferably COVID-19 negative status at time of tracheostomy→ | Exclusion criteria: Patients not satisfying the above criteria were all excluded→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | outcome of early tracheostomies in covid 19 patientsTimepoint: 2 week, 4 week, 6 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/05/033446 | 24 May 2021 | Study to estimate the risk factors associated with deaths due to COVID-19 infection | Mortality in patients with Covid-19 in a tertiary center in North Kerala : clinical , demographic and laboratory parameters | | Dr Manu Mathews | 07-05-2021 | 20210507 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55837 | Not Recruiting | No | | | | 20-05-2021 | 450 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Manu Mathews→ | | Dhanya House
Makuni Road
Pallikkunnu
Kannur District 4 th floor
Room 406
Department of Medicine
Government medical College kannur
Pin 670503→ | manumathews123@gmail.com→ | 08156991383→ | Government Medical College Kannur,kerala→ | Inclusion criteria: All patients aged more than 18 yrs with documented covid-19 infection and expired during their hospital stay in the study period→ | Exclusion criteria: Patients with documented covid -19 infection but expired due to causes definitely other than covid -19 like suicides , accidents etc→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To evaluate the demographic, clinical and laboratory parameters of patient expired due to covid-19 <br/ ><br>To study the comorbidities and complications of patients expired due to the covid-19 infectionTimepoint: Retrospective study with study period April 1,2020 to March 31, 2021 (1 year )→ | | | | Yes | False | | |
| → | CTRI/2021/05/033472 | 24 May 2021 | Clinical trial of CIM-Meg19 to combat the severity of disorders in COVID-19 and post COVID-19 patients | A study to assess efficacy and safety of proprietary Ayurvedic formulation [CIM-MEG19] as immune booster as well as alternate standard care in COVID-19 positive and post- COVID-19 patients to combat the severity/recovery of symptoms/disorders - CSIR-CIMAP [CIM-Meg19] | | Ms Meghdoot Gramodyog Sewa Sansthan | 07-05-2021 | 20210507 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55846 | Not Recruiting | No | | | | 17-05-2021 | 80 | Interventional | Non-randomized, Active Controlled Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Karuna Shanker→ | | Phytochemistry Division
CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknow → | du.bawankule@cimap.res.in→ | 9415329719→ | CSIR-CIMAP, Lucknow→ | Inclusion criteria: a) Age- 35-90 years <br/ ><br>b) Gender- Male or non-pregnant, non-lactating female patient aged â?¥35andâ?¤90 years (both inclusive) <br/ ><br>c) Mild to moderate cases of COVID-19 <br/ ><br>d) Capable of taking oral drugs <br/ ><br>e) SpO2 > 93% in room air <br/ ><br>f) PaO2 /FiO2 : 200-300 <br/ ><br>g) RR < 24 /min <br/ ><br>h) No evidence of hypoxemia or breathlessness <br/ ><br>i) Subject may be discontinued from the study if confirmatory test results are available subsequently and are negative for COVID 19 infection. <br/ ><br> <br/ ><br>→ | Exclusion criteria: a) Patients who are unwilling to participate in the study. <br/ ><br>b) Patients with known sensitivity to any of the ingredients of the trial drug. <br/ ><br>c) Presence of acute hypoxic respiratory failure. <br/ ><br>d) Patients who require ICU stay. <br/ ><br>e) Patients requiring mechanical ventilation. <br/ ><br>f) Category 5 or 6 based on modified 7- category ordinal scale of clinical status. <br/ ><br>g) Any pre-existing GI symptoms like nausea or vomiting. <br/ ><br>h) Patients suffering from bleeding hemorrhoids. <br/ ><br>→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: CIM-Meg19: Dosage Form: 02 Tablets<br>Duration : Day 1 to Day 21<br>Route: Orally twice daily after meal.<br>Control Intervention1: Standard of care: 1. Patients on Standard care medicines who are not willing to take the drug [CIM-MEG19].<br>2. Cases of COVID 19 shall be treated with standard treatment as per hospital protocol for COVID-19 until the recovery from Day 1 to Day 21<br><br>→ | In subjective QOL, using WHO QOLTimepoint: Day 0, 7, 14,21→ | | | | Yes | False | | |
| → | CTRI/2021/05/033471 | 24 May 2021 | lung changes in patient recovered with covid and coming for a surgery | Intraoperative lung protective strategies and postoperative pulmonary complications in covid recovered patients - PPCC | | St Johns Medical College Hospital | 07-05-2021 | 20210507 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54655 | Not Recruiting | No | | | | 31-05-2021 | 36 | Observational | Other
Method of generating randomization sequence: Method of allocation concealment: Blinding and masking:→Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | DrRoshni Benedicta→ | | Dept Of Anesthesia
St Johns Medical College Hospital
Bangalore
→ | drmanjula95@yahoo.com→ | 9449059395→ | St Johns Medical College Hospital→ | Inclusion criteria: Patients with previous H /O covid infection undergoing surgery under General anesthesia <br/ ><br>Age 18-59 years of either sex <br/ ><br> <br/ ><br>→ | Exclusion criteria: Body mass index (BMI) > 30 <br/ ><br>H/o obstructive sleep apneoa <br/ ><br>Previous h/o COPD, Interstitial lung disease <br/ ><br>Patients with tracheostomy for covid ventilation <br/ ><br>→ | Health Condition 1: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified
Health Condition 2: J958- Other intraoperative and postprocedural complications and disorders of respiratory system, not elsewhere classified
→ | | To estimate the incidence of postoperative pulmonary complications (PPC) in patients recovered from covid infection and scheduled for surgeryTimepoint: postoperative day 1 to day 28→ | | | | Yes | False | | |
| → | CTRI/2021/05/033518 | 24 May 2021 | Lung function in post covid | Assessment of Respiratory Morbidities and Lung Function in COVID 19 survivors: An Observational Study | | All India Institute of Medical Sciences | 10-05-2021 | 20210510 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54053 | Not Recruiting | No | | | | 20-05-2021 | 60 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rahul Khera→ | | Department of Pulmonary Medicine
All India Institute of Medical Sciences
Tatibandh GE Road
→ | sajalde@yahoo.com→ | 9406573825→ | All India Institute of Medical Sciences Raipur→ | Inclusion criteria: Participants 18 years of age or older who had a confirmed positive COVID 19 infection.→ | Exclusion criteria: 1. Refusal to give consent for the study. <br/ ><br>2. Participants age less than 18 years. <br/ ><br>3. Participants with pre-existing lung diseases like asthma, chronic obstructive pulmonary disease, interstitial lung disease etc. <br/ ><br>4. Participants with contraindications for lung function studies.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | To assess the prevalence and severity of respiratory morbidities in COVID 19 survivors.Timepoint: at baseline and 3 months of follow up→ | | | | Yes | False | | |
| → | CTRI/2021/05/033523 | 24 May 2021 | A comparative study of High dose corticosteroids pulse versus standard of care in severe COVID19 pneumonia | High dose corticosteroids pulse versus standard of care in severe COVID19 pneumonia: A randomized, open label, multicentre, controlled trial. | | Post Graduate Institute of Medical Sciences PGIMS Rohtak | 10-05-2021 | 20210510 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55876 | Not Recruiting | No | | | | 17-05-2021 | 200 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dhruva Chaudhry→ | | Department of Pulmonary and Critical Care Medicine, PGIMS Rohtak → | dhruvachaudhry@yahoo.co.in→ | 9416051616→ | Pt. B.D. Sharma PGIMS, Rohtak→ | Inclusion criteria: COVID19 confirmed case (with nasal or oral swab RT-PCR or rapid antigen positive). <br/ ><br>Chest radiograph suggestive of pneumonia. <br/ ><br>Severity scale according to WHO ordinal scale score of either 4 or 5 or 6 (oxygen requirement or HFNC requirement or NIV requirement or invasive mechanical ventilation). <br/ ><br>Able to and willing to provide informed consent. <br/ ><br>→ | Exclusion criteria: Patients belonging to category 7 (requiring ECMO or vasopressor support). <br/ ><br>Pregnant subjects. <br/ ><br>Patients participating in other clinical trials. <br/ ><br>Known case of any psychiatric illness. <br/ ><br>Treating physician assessed high likelihood of mortality in 72 hours of randomization. <br/ ><br>Subjects who have received steroids dose of over 0.4 mg/kg/day of dexamethasone or 2mg/kg/day of methylprednisolone for over 2 day in past 14 days. <br/ ><br>Co-existing condition mandating the use of high dose steroids. <br/ ><br>Life threatening comorbidities like <br/ ><br>a. CKD requiring dialysis. <br/ ><br>b. Life threatening new onset arrythmia. <br/ ><br>c. Hypotension. <br/ ><br>d. Evidence or suspicion of active bacterial infection. <br/ ><br>e. Evidence or suspicion of acute onset renal or liver failure <br/ ><br>f. Child C category of chronic liver disease. <br/ ><br>g. Co-existing autoimmune disease requiring immunosuppressive drugs. <br/ ><br>h. Concurrent use of tocilizumab/baricitinib/itolizumab. <br/ ><br>→ | Health Condition 1: B342- Coronavirus infection, unspecified
→ | Intervention1: pulse steroid arm: Drug - Methylprednisolone, <br>Dose - 250 mg, <br>Route - Intravenously,<br>Frequency - once a day, <br>Duration - for 3 days after randomization<br>Control Intervention1: standard of care: patients will be managed according to the clinical management protocol for COVID19 by MoHFW version5 (dated 03.07.2020)<br>→ | Primary efficacy end point will be time to recovery where recovery is defined as fall of 2 points in WHO 8-point ordinal scale or liberation from oxygen therapy.Timepoint: 0, 3rd, 7th, 14th, 28th day→ | | | | Yes | False | | |
| → | CTRI/2021/05/033499 | 24 May 2021 | Efficacy of Karpoor and Ajwain inhalation in COVID-19 patients | Effects of add on Cinnamomum Camphora and Ajwain inhalation to the standard treatment
on oxygen saturation in patients with COVID-19: A prospective studyathing pacer" in patients
with COPD | | D Y Patil University School of Medicine | 10-05-2021 | 20210510 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55679 | Recruiting | No | | | | 14-05-2021 | 100 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Bharati Kulkarni→ | | Surgery OPD, First floor,
DY Patil Hospital DY Patil deemed to be University School of Medicine, Plot NO. 2, Sector 5, Nerul, Navi Mumbai→ | bharati.kulkarni@dypatil.edu→ | 9820554431→ | D Y Patil University School of Medicine→ | Inclusion criteria: 1. Adult ( >18 years) COVID-19 positive patients of either gender <br/ ><br>2. Patients hospitalized in COVID-19 wards <br/ ><br>3. Patients having SpO2 saturation of â?¥90% on room air at enrolment <br/ ><br>→ | Exclusion criteria: 1. Patients on mechanical ventilation <br/ ><br>2. Patients requiring nasal oxygen >6 litres/minutes <br/ ><br>3. Patients with respiratory disorders, bronchial asthma, or COPD <br/ ><br>4. Existing pulmonary tuberculosis <br/ ><br>5. Patients admitted in ICU <br/ ><br>6. Pregnant women <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Study Inhaler: Inhaler containing Cinnamomum Camphora (1 gm) and Trachyspermum ammi (1 gm)<br>Dose: Deep inhalation (3-4 puffs) at least every two hours during awake period, OR as frequently as possible<br>Control Intervention1: Placebo Inhaler: Inhaler containing cotton (Placebo)<br>Administratione: Deep inhalation (3-4 puffs) at least every two hours during awake period, OR as frequently as possible<br>→ | Time to recovery (defined as the satisfaction of criteriaâ??s 1, 2 or 3 of the 8-category ordinal scale for clinical improvement)Timepoint: End of study (up to 28 days)→ | | | | Yes | False | | |
| → | CTRI/2021/05/033526 | 24 May 2021 | Fatigue and Quality of life in post COVID-19 patients | Fatigue and Quality of life in post COVID-19 patients | | indian spinal injuries centre | 10-05-2021 | 20210510 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55487 | Not Recruiting | No | | | | 21-05-2021 | 60 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Lipika Malik→ | | Indian spinal injuries centre, opp. Vasant Valley School, IAA Colony, Sector C, Vasant Kunj, New Delhi. → | ashishjha2712@gmail.com→ | | Indian Spinal Injuries Centre→ | Inclusion criteria: 6 weeks must have passed after last symptom/ negative report→ | Exclusion criteria: chronic depression, cognitive disability, serious co-morbidity→ | | Intervention1: NIL: NIL<br>→ | Chalder fatigue scaleTimepoint: one time→ | | | | Yes | False | | |
| → | CTRI/2021/05/033545 | 24 May 2021 | Depression in Pregnant women due to COVID-19 pandemic in India | To assess the impact of COVID-19 pandemic on depression among pregnant women-A cross-sectional study | | JSS college of Pharmacy Ooty | 11-05-2021 | 20210511 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55823 | Not Recruiting | No | | | | 24-05-2021 | 120 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | SHONITHA S→ | | Department of Pharmacy Practice
ROCKLANDS→ | roopabs@jssuni.edu.in→ | 9047155003→ | JSS COLLEGE OF PHARMACY,OOTY→ | Inclusion criteria: Maternal age of 18 years or greater at the time of consent. <br/ ><br>Gestational week: 32 to 40 weeks (Third trimester) <br/ ><br>The ability to provide written informed consent. <br/ ><br>→ | Exclusion criteria: Pregnant women with the gestational week under six (Early first trimester) <br/ ><br>Pregnant women with chronic disease like chronic hypertension, kidney and liver disease, pre-pregnancy diabetes mellitus <br/ ><br>Patient with reported depression in the past <br/ ><br>History of use of anti-depressants and other drugs which cause depression. <br/ ><br>History of high-risk pregnancy including abruption placenta, placenta previa, gestational diabetes, coagulation disorders, thrombocytopenia or history of drug abuse. <br/ ><br>History of autoimmune diseases <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Whether COVID-19 pandemic is a possible risk factor for the development of depression among the pregnant and non-pregnant women.Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/05/033537 | 24 May 2021 | Will treatment with a drug named colchicine be useful in treating Corona virus infection in kidney failure patients who are on regular dialysis? | Colchicine for treating SARS-CoV-2 infection in maintenance hemodialysis patients: a prospective, open label, randomized controlled trial - NIL | | CMC Fluid research Funding | 11-05-2021 | 20210511 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55323 | Not Recruiting | No | | | | 24-05-2021 | 80 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Utkarash Mishra→ | | Department of Nephrology
Christian Medical College
Vellore → | santosh.vellore@gmail.com→ | 9442380267→ | Christian Medical College, Vellore→ | Inclusion criteria: Patients with end stage kidney disease who are on maintenance hemodialysis in our institute, who develop SARS-CoV-2 infection and who do not meet exclusion criteria, after written informed consent.→ | Exclusion criteria: 1.Age < 18 years <br/ ><br>2.Not willing to enter the study <br/ ><br>3.Known hypersensitivity to colchicine. <br/ ><br>4.Inflammatory bowel disease, chronic diarrhea or malabsorption <br/ ><br>5.Previous neuromuscular disease <br/ ><br>6.Cirrhosis, active chronic hepatitis or severe hepatic disease defined by SGOT or SGPT levels three times above the normal upper limit <br/ ><br>7.Treatment with immunosuppressive agents, corticosteroids or interleukine-1 antagonists for 6 months before inclusion <br/ ><br>8.Pregnant or breastfeeding females <br/ ><br>9.Patient currently taking colchicine for indications other than SARS-CoV-2 infection prophylaxis <br/ ><br>10.History of prolongation of the QT interval (eg. History of torsades de pointes, congenital long QT syndrome, bradyarrhthmia) <br/ ><br>11.Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Colchicine and Standard of care for the treatment of SARS-CoV-2 infection: All patients will be receiving loading dose of 1mg and thereafter once daily oral colchicine <br>0.5mg for a period of at least 3 weeks or till clinical improvement.<br><br>Control Intervention1: The standard of care treatment of SARS-CoV-2 infection: The Standard of care for COVID infection as per institution protocol are:<br>1.To give prophylactic anti-coagulation with unfractionated heparin- if D-dimer more than 500, presence of risk factors for thrombotic disease, in all patients with moderate to severe COVID infections.<br>2.To give therapeutic anticoagulation with unfractionated heparin if there is evidence of thromboembolism or high suspicion of thromboembolism. <br>3.If the patient is requiring oxygen to give Dexamethasone injection 6mg intravenously once daily for minimum duration of 10 days. <br>4.If significant respiratory support requirement, to consider prone ventilation, non-invasive or invasive ventilatory support and ICU care as needed.<br>Other symptomatic and supportive measures<br><br>→ | Time to deterioration by 2 points on the WHO clinical progression scale, ranging from asymptomatic viral RNA detection to deathTimepoint: Day0 <br/ ><br>Day7 <br/ ><br>Day21 <br/ ><br>Day30→ | | | | Yes | False | | |
| → | CTRI/2021/05/033543 | 24 May 2021 | Clinical trial of CIM-Meg19 in COVID-19 patients | A study to assess efficacy and safety of Ayurvedic formulation [CIM-MEG19] as an add-on therapy to the standard care in mild to moderate COVID 19 positive to combat the severity / recovery of symptoms / disorders - CSIR-CIMAP-CIM-MEG19 | | Ms Meghdoot Gramodyog Sewa Sansthan | 11-05-2021 | 20210511 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55879 | Not Recruiting | No | | | | 17-05-2021 | 80 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Not Applicable→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Karuna Shanker→ | | Phytochemistry Division, CSIR-Central Institute of Medicinal and Aromatic Plants, Lucknowd, Pune → | asmita.wele@gmail.com→ | 09923356085→ | College of Ayurved, Bharati Vidyapeeth→ | Inclusion criteria: COVID-19 RT-PCR positive patients <br/ ><br>Male or Female of age 18-70 years <br/ ><br>Subject is ready to give written Informed consent <br/ ><br>Can take oral medicines <br/ ><br>Mild to moderate grade of the disease. Mild- Upper respiratory tract symptoms of fever with or without shortness of breath or hypoxia. Moderate- Any one of- 1. Respiratory rate more than 24/min, breathlessness 2. SpO2: 90-93% on room air. 3. PaO2 /FiO2 : 200-300/g) as per AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring Group recommendations <br/ ><br>Not participating in any other interventional drug study g) Agree to follow all study procedures <br/ ><br>→ | Exclusion criteria: Known sensitivity to the ingredients of IP <br/ ><br>Bleeding haemorrhoids <br/ ><br>Pre-existing GI symptoms like nausea or vomiting <br/ ><br>Presence of acute hypoxic respiratory failure <br/ ><br>Intensive care unit (ICU) stay- <br/ ><br>Patients who need mechanical ventilation <br/ ><br>Category 6 or 5 based on modified 7-category ordinal scale of clinical status <br/ ><br>Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely Severe infection <br/ ><br>Pregnant or lactating women <br/ ><br>For Arm A: subjects receiving any antiviral treatment for Covid (like Favipiravir, Remdesivir) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: CIM-Meg19: 02 tablets two times a day after meal to be administered orally.<br>Control Intervention1: Standard care treatment: Standard care treatment as per siteâ??s routine practice / physicianâ??s opinion or as per current guidelines.<br>→ | A. To assess time to 2 point improvement (from time of enrolment) on the WHO ordinal scaleTimepoint: Days- 0, 4, 8 and 21→ | | | | Yes | False | | |
| → | CTRI/2021/05/033544 | 24 May 2021 | Comparison of efficacy of Indomethacin vs Paracetamol along with standard care of treatment in mild and moderate Covid-19 patients | A Prospective, randomized, open-labelled, active comparator trial of Indomethacin versus Paracetamol among hospitalized patients with confirmed Covid-19. | | IIT Madras | 11-05-2021 | 20210511 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55941 | Not Recruiting | No | | | | 20-05-2021 | 100 | Interventional | Other
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label→Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2 | India→ | Ramarathnam Krishna Kumar→ | | Department of Engineering Design, Frist floor, 212,
Indian Institute of Technology Madras, Chennai, India. → | ravidoc55@yahoo.co.in→ | 9840375892→ | MIOT International→ | Inclusion criteria: Age between 20 to 90 years <br/ ><br> <br/ ><br>RT â?? PCR Positive <br/ ><br> <br/ ><br>Hospitalised patients <br/ ><br> <br/ ><br>The case criteria for the study â?? Renal Function Test and Liver Functional Test should be normal at the screening; Oxygen saturation should be 95% or more <br/ ><br>→ | Exclusion criteria: Hypersensitivity/Allergy to Drug <br/ ><br>Gastritis <br/ ><br>Recent Heart attack <br/ ><br>Severe Asthma <br/ ><br>Acute Kidney Injury. <br/ ><br>Patients on immune suppressants <br/ ><br>â?¢ To Exclude pregnant and lactating mothers <br/ ><br>â?¢ Specify NSAID/Indomethacin allergy <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J99- Respiratory disorders in diseasesclassified elsewhere
→ | Intervention1: Indomethacin: Drug dose - Capsule (C) - 75 mg sustained release formulation once daily for 5 days for subjects with BMI less than 30;<br>C. 75 mg twice daily for 5 days for subjects with BMI more than 30 will be administered orally, <br>along with standard care of treatment that includes the following <br><br>C. Doxycycline â?? 100 mg bd; Tablet (T). Ivermectin â?? 12 mg once daily (OD); T. vitamin C 500 mg and D3 60k IU weekly once; T. Zinc 50 mg OD; Cough syrup SOS; T. Cetrizine 10 mg OD /T. Ketotifen 1mg bd SOS; T. Pantoperazole 40 mg bd<br>Control Intervention1: Paracetamol: Tablet - paracetamol 650 mg 4 times daily for 5 days along with same standard care of treatment mentioned for the intervention drug will be administered orally.<br>→ | Reduction in Covid-19 symptoms and the intervention is expected to be beneficial in reducing the Covid 19 symptoms than the comparatorTimepoint: Day 0 screening <br/ ><br>Day 1 to 5 drug administration <br/ ><br>Day 7 end of study→ | | | | Yes | False | | |
| → | CTRI/2021/05/033546 | 24 May 2021 | COVID-19 viral disease | Multi-Arm Therapeutic Study in Pre-ICU Patients Admitted With Covid-19 â?? Experimental Drugs and Mechanisms - TACTIC-E | | Cambridge University Hospitals NHS Foundation Trust | 11-05-2021 | 20210511 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48547 | Not Recruiting | No | | | | 31-05-2021 | 1407 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India;Mexico;United Kingdom→ | Dr V Ramasubramanian→ | | Department of Infectious disease
21 Greams Lane
Off Greams Road
Chennai → | idisdoc@gmail.com→ | | Apollo Hospitals→ | Inclusion criteria: Have clinical picture strongly suggestive of COVID-19-related disease (with/without positive COVID-19 test) AND <br/ ><br> - Risk count (as defined above) >3 <br/ ><br> OR <br/ ><br> - Risk count ï?³3 if it includes â??Radiographic severity score >3â?? <br/ ><br>Be considered an appropriate subject for intervention with immunomodulatory or other disease modifying agents in the opinion of the investigator <br/ ><br>Is able to swallow capsules/tablets <br/ ><br> <br/ ><br>Risk count (score 1 point for each of the following): <br/ ><br>Radiographic severity score >3 <br/ ><br>Male gender <br/ ><br>Non-white ethnicity <br/ ><br>Diabetes <br/ ><br>Hypertension <br/ ><br>Neutrophils >8.0 x109/L <br/ ><br>Age >40 years <br/ ><br>CRP >40 mgl/L→ | Exclusion criteria: General exclusion criteria <br/ ><br>The presence of any of the following will preclude participant inclusion: <br/ ><br>Inability to supply direct informed consent from patient or from Next of Kin or Independent Healthcare Provider on behalf of patient <br/ ><br>Invasive mechanical ventilation at time of screening <br/ ><br>Contraindications to study drugs, including hypersensitivity to the active substances or any of the excipients <br/ ><br>Currently on any of the study investigational medicinal products <br/ ><br>Concurrent participation in an interventional clinical trial (observational studies allowed) <br/ ><br>Patient moribund at presentation or screening <br/ ><br>Pregnancy at screening <br/ ><br>Unwilling to stop breastfeeding during treatment period <br/ ><br>Known severe hepatic impairment (with or without cirrhosis) <br/ ><br>Stage 4 severe chronic kidney disease or requiring dialysis (i.e. Cockcroft Gault estimated creatinine clearance < 30 ml /min) <br/ ><br>Inability to swallow at screening visit <br/ ><br>Any medical history or clinically relevant abnormality that is deemed by the principal investigator and/or medical monitor to make the patient ineligible for inclusion because of a safety concern. <br/ ><br>Drug specific exclusion criteria <br/ ><br>EDP1815 Specific Exclusions <br/ ><br>Patient is taking a systemic immunosuppressive agent such as, but not limited to, oral steroids, methotrexate, azathioprine, ciclosporin or tacrolimus, unless these are given as part of COVID standard of care treatment. <br/ ><br>Dapagliflozin and Ambrisentan Specific Exclusions <br/ ><br>Type 1 diabetes <br/ ><br>Known idiopathic pulmonary fibrosis <br/ ><br>Previous hospital admission with ketoacidosis <br/ ><br>History of symptomatic heart failure within 3 months of admission <br/ ><br>Sustained blood pressure below 90/60 mmHg at admission <br/ ><br>Metabolic acidosis defined as venous pH < 7.3 (or venous bicarbonate <15 mmol/l) AND ketones > 3.0 mmol/L <br/ ><br>Alanine transaminase and/or aspartate transaminase (ALT and/or AST) > 3 times the upper limit of normal (only one needs to be measured)→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B998- Other infectious disease
→ | Intervention1: EDP1815: 2 capsules twice daily for 14 days<br>Control Intervention1: Ambrisentan: 5mg OD for 14 days<br>Control Intervention2: Dapagliflozin: 10 mg OD for 14 days<br>→ | Death <br/ ><br>Invasive mechanical ventilation <br/ ><br>ECMO <br/ ><br>Cardiovascular organ support <br/ ><br>Renal failureTimepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2021/05/033588 | 24 May 2021 | Study of outcome of newborn babies born to mothers who are COVID-19 positive at a tertiary hospital in Gujarat | Study of outcome of neonates born to COVID-19 positive mothers at a tertiary care centre in Gujarat, India | | GCS Medical College and Research Centre Ahmedabad | 12-05-2021 | 20210512 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54860 | Not Recruiting | No | | | | 01-06-2021 | 75 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sheena Sivanandan→ | | Department of Pediatrics
4th floor
GCS Medical College
Near Chamunda Bridge
Naroda Road
Ahmedabad → | sheena_sivanandan@yahoo.co.in→ | 079-66048000→ | GCS Medical College and Research Centre→ | Inclusion criteria: All neonates born to mothers admitted with positive COVID â?? 19 [diagnosed by a positive real-time reverse transcriptaseâ??polymerase chain reaction (rT â??PCR) test]→ | Exclusion criteria: Neonates who have been discharged against medical advice or transferred to other centres <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | Clinical profile of neonates born to COVID positive mothers <br/ ><br>Timepoint: 18 months→ | | | | Yes | False | | |
| → | CTRI/2021/05/033576 | 24 May 2021 | Study to investigate the safety and efficacy of the health supplements ImmunoSEB and ProbioSEB CSC3 on patients suffering from COVID-19 Induced Fatigue/Post Viral Fatigue Syndrome.
| A randomized multicentric Double Blind placebo controlled 2-Arm prospective study to investigate the safety and efficacy of the health supplements ImmunoSEB ProbioSEB CSC3 on patients suffering from COVID-19 Induced Fatigue Post Viral Fatigue Syndrome
| | Advanced Enzyme Technologies Ltd | 12-05-2021 | 20210512 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54949 | Not Recruiting | No | | | | 22-05-2021 | 200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded→Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | Mukul Maurya→ | | ProClin Research Private Limited.
Second Floor, IT Tower Plot No.29,Sector 142 Noida Gautam Buddha Nagar Uttar Pradesh → | rohitparate963@gmail.com→ | 9630033342→ | Chirayu Medical College and Hospital→ | Inclusion criteria: Inclusion Criteria: <br/ ><br> Subjects will be included in the study if they meet all of the following criteria: <br/ ><br>1.Provides written informed consent <br/ ><br>2.Male or non-pregnant, non-lactating female aged â?¥ 18 and â?¤ 75 years (both inclusive) <br/ ><br>3.RT-PCR confirmed diagnosis of Covid-19 at any time followed by an RT-PCR negative test <br/ ><br>4.Patients who are experiencing fatigue and muscle weakness <br/ ><br>5.Able to take the drug orally and comply with study procedures <br/ ><br>6.Women of childbearing potential must have a negative urine pregnancy test prior to study entry→ | Exclusion criteria: EXCLUSION CRITERIA <br/ ><br>Patient will be deemed ineligible to participate in the study if he/she fulfils any of the following criteria: <br/ ><br>1.Patients with severe to critical type of health condition as stratified below: <br/ ><br>2.Clinical stratification: <br/ ><br>3.Severe type: meeting any of the following criteria: <br/ ><br>(a)Respiratory distress, RRâ?¥30 times/min <br/ ><br>(b)Finger oxygen saturation â?¤90% in resting state <br/ ><br>(c)Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation (FiO2)â?¤300mmHg. <br/ ><br>4.Critical type: meeting any of the following criteria: <br/ ><br>(a)Respiratory failure occurs and mechanical ventilation is required; <br/ ><br>(b)Patients go into shock; <br/ ><br>(c) ICU is needed for other organ failure. <br/ ><br>5.Other viral pneumonia Patients who can not take food or drugs due to coma or intestinal obstruction <br/ ><br>6.Consumption of other oral probiotic supplements during the trial <br/ ><br>7.Patients who have severe underlying diseases that affects survival, including uncontrolled malignant tumor with multiple metastases that cannot be resected, blood diseases, dyscrasia, active bleeding, severe malnutrition, etc. <br/ ><br>8.Women subjects that are pregnant or lactating, or subjects (including male subjects) having a pregnancy plan (including plans for sperm donation or egg donation) during the study period <br/ ><br>9.Allergic to systemic enzyme supplements. <br/ ><br>10.Imminent death in the opinion of the clinical team <br/ ><br>11.Patients with Hb less than 8 mg/dl <br/ ><br>13.Patients who have participated in any other clinical study within 2 weeks prior to randomization; <br/ ><br>14.The investigator concludes that the patient is not suitable for the study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ImmunoSEB ProbioSEB CSC3: ImmunoSEB + ProbioSEB CSC3: 2 capsules ImmunoSEB bid (500 mgs) + 2 capsules ProbioSEB CSC3 (5 billion CFUs) od for 14 days<br>Control Intervention1: Placebo: Maltodextrin<br>→ | 1.Proportion of patients showing improvement on Chalder Fatigue Scale. <br/ ><br>2. Proportion of patients showing Improvement in mental Fatigue on CFQ.Timepoint: 1.Proportion of patients showing improvement in physical Fatigue on CFQ [Time Frame: Day 14] <br/ ><br>2.Proportion of patients showing Improvement in mental Fatigue on CFQ [Time Frame: Day 14] <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/05/033592 | 24 May 2021 | Perception of public about COVID-19 Vaccination | Perception of public about COVID-19 Vaccination: An Exploratory Survey | | Shalini G Nayak | 12-05-2021 | 20210512 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55994 | Not Recruiting | No | | | | 25-05-2021 | 1094 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shalini Nayak→ | | Room No. 403, Department of medical Surgical Nursing. Manipal College of Nursing
Manipal Academy of Higher Education, Manipal → | anil.raj@manipal.edu→ | | Manipal College of Nursing→ | Inclusion criteria: All above 18 years of age and willing to participate, able to read English and residing in India will be included.→ | Exclusion criteria: Nil→ | | Control Intervention1: Not interventional study: No Intervention in this study<br>→ | Perception of public towards COVID-19 vaccinationTimepoint: only at base line→ | | | | Yes | False | | |
| → | CTRI/2021/05/033605 | 24 May 2021 | Will colchicine be useful as an agent to prevent SARS-CoV-2 infection in kidney failure patients who are on maintenance hemodialysis? | Colchicine for prophylaxis against SARS-CoV-2 infection in maintenance hemodialysis patients: a prospective, open label, randomized controlled trial - NIL | | CMC Fluid research Funding | 13-05-2021 | 20210513 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55324 | Not Recruiting | No | | | | 20-05-2021 | 200 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Utkarash Mishra→ | | Dept of Nephrology
Christian medical College, Vellore → | santosh.vellore@gmail.com→ | 9442380267→ | Christian Medical College, Vellore→ | Inclusion criteria: Patients with end stage kidney disease who are on maintenance hemodialysis in our institute, not meeting exclusion criteria, after written informed consent.→ | Exclusion criteria: 1.Age < 18 years <br/ ><br>2.Not willing to enter the study <br/ ><br>3.Known hypersensitivity to colchicine <br/ ><br>4.Inflammatory bowel disease, chronic diarrhea or malabsorption <br/ ><br>5.Previous neuromuscular disease <br/ ><br>6.Cirrhosis, active chronic hepatitis or severe hepatic disease defined by SGOT or SGPT levels three times above the normal upper limit <br/ ><br>7.Treatment with immunosuppressive agents, corticosteroids or interleukin-1 antagonists for 6 months before inclusion <br/ ><br>8.Pregnant or breastfeeding females <br/ ><br>9.Patient currently taking colchicine for other indications <br/ ><br>10.Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Colchicine prophylaxis and the standard of care preventive measures for SARS-CoV-2 infection: In the intervention arm, all patients will be receiving tablet colchicine 0.5mg per-orally thrice weekly as SARS-CoV-2 infection <br>prophylaxis in addition to the standard of care preventive measures for a period of 24 months<br><br>Control Intervention1: The Standard of care preventive measures for SARS-CoV-2 infection: The Standard of care preventive measures for SARS CoV2 infection such as use of face masks, frequent hand washing, social distancing etcâ?¦<br>→ | To estimate the incidence of SARS-CoV-2 infection during a follow up period of 24 months in both the groupsTimepoint: To estimate the incidence of SARS-CoV-2 infection during a follow up period of 24 months in both the groups→ | | | | Yes | False | | |
| → | CTRI/2021/05/033599 | 24 May 2021 | Effect of Online Classroom in Infection Prevention
and Control Training of Undergraduate Students during COVID-l9 Pandemic | Effect of Flipped Classroom in Infection Prevention
and Control Training of Undergraduate Students during COVID-l9 Pandemic | | AIIMS Rishikesh | 13-05-2021 | 20210513 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55286 | Not Recruiting | No | | | | 25-05-2021 | 300 | Interventional | Randomized, Parallel Group, Multiple Arm Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Investigator Blinded→Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Investigator Blinded | N/A | India→ | Dr Amber Prasad→ | | Department of Microbiology
AIIMS Rishikesh
Rishikesh → | dramberpd@gmail.com→ | | AIIMS Rishikesh→ | Inclusion criteria: All the students pursuing M.B.B.S. course, including interns, in the institute who give consent to participate in the study.→ | Exclusion criteria: Exclusion criteria: Those students not willing to participate in the study will be excluded→ | | Intervention1: Group 1: Flipped class: Pre- Training Assessment: All the participants will be sent a Google based questionnaire to assess their pre training knowledge. The students will be encouraged to complete their pre training assessment before attending the training session.<br>Group 1 will be considered as experiment group wherein students will be trained via Flipped classroom training methodology. Study material including video lectures pertinent to standard and additional precautions, with an emphasis over specific precautions to be taken with respect to COVID-19, will be shared to the Group 1 students. After the sharing the study material, the students will be given time of 1-2 day to go through the study material.<br>The students will be requested to enlist all their queries and mail them to the study coordinators. One hour discussion session will be scheduled after 1-2 day of pre-assessment. Apart from discussing over the important aspects of infection control and the training topics, all the queries of the students would be taken up and explained in detail.<br>Control Intervention1: Group 2 : Live class: Group 2 will be considered as control group and live teaching methodology on virtual platform or in class, would be used for training. The students will not be given any study material prior to training and all lectures will be conducted live followed by discussion session. <br>Post Training Assessment: All the participants of both the groups will be sent post training assessment at same time and they would also be assessed practically for hand hygiene.<br>→ | Knowledge Acquisition [ Time Frame: Baseline (Before class), immediately after completing the class, 3 months after class ] <br/ ><br>Participants will be assessed a total of three times for each course: once prior to starting the class (pre-test), once immediately after completing the class (post-test), and once three months later. All assessments consist of Google form based questionnaire which has been validated by 7 experts.Timepoint: 30 minutes to complete each test.→ | | | | Yes | False | | |
| → | CTRI/2021/05/033622 | 24 May 2021 | Plasma therapy (IgG) in moderate to severe COVID-19 patients | A Randomized, Open-label Parallel Group Study to Evaluate Efficacy and Safety of Intravenous Immunoglobulin (IVIG) in Hospitalized patients with COVID-19 - IVIG | | Lok Nayak Hospital | 14-05-2021 | 20210514 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56002 | Not Recruiting | No | | | | 21-05-2021 | 60 | Interventional | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Govind Mawari→ | | 129, B.L Taneja Block, Department of Medicine, Maulana Azad Medical College → | drmraduldaga@gmail.com→ | 9968604273→ | Maulana Azad Medical College→ | Inclusion criteria: Male or female subjects in between 18 years to 65 years <br/ ><br>1. Moderate Illness: Adolescent or adult with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 â?¤94% (range: 90-94%) on room air, Respiratory rate more or equal to 24 breaths per minutes. (As per MoHFW) <br/ ><br>2. Severe Illness: Adolescent or adult with clinical signs of severe Pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90% on room air. (As per MoHFW) <br/ ><br>→ | Exclusion criteria: Known hypersensitivity to immunoglobulin. <br/ ><br>History or presence of any disorder that increases the safety risk of the patient as per investigator discretion. <br/ ><br>History of DVT, PE, thromboembolic stroke or other thrombotic events. <br/ ><br>Active participant in another research treatment study. <br/ ><br>Pregnancy. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Intravenous Immunoglobulin (IVIG)<br>: 400mg /kg b.w. per day for 5 days<br>Control Intervention1: not applicable: not applicable<br>→ | Clinical improvement measured by improvement in National Early Warning Score 2 (NEWS2) Score at the end of treatmentTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/05/033623 | 24 May 2021 | Recording of the effects of select AYUSH drugs, Ayush-64 and Kabasura Kudineer in Covid-19 patients in home isolation. | Documentation of efficacy of select AYUSH Interventions Ayush-64 and Kabasura Kudineer in asymptomatic & mild to moderate Covid-19 patients in home isolation. - NA | | Ministry of AYUSH Govt of India | 16-05-2021 | 20210516 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56044 | Not Recruiting | No | | | | 22-05-2021 | 500000 | Interventional | Single Arm Trial
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 4 | India→ | Dr Narayanam Srikanth→ | | CCRAS,JLN Bhartiya Chikitsa evam Homoepathy Anusandhan Bhawan, 61-65, Institutional Area, Opp. D Block, Janakpuri,(Ministry of AYUSH, Government of India) → | srikanthccras@gmail.com→ | | Central Council for Research in Ayurvedic Sciences, Ministry of AYUSH, Govt.of India→ | Inclusion criteria: â?¢ Individuals of any gender within the age group 18-60 years <br/ ><br>â?¢ Individuals diagnosed as COVID 19 and categorized as asymptomatic, mild or moderate disease <br/ ><br>â?¢ within < One week of confirmation of COVID 19 disease <br/ ><br>â?¢ Patients in home isolation under standard care as per the government guidelines <br/ ><br>â?¢ Patients providing informed consent and willing to participate in the clinical study <br/ ><br>→ | Exclusion criteria: â?¢ Patients not willing to use the Ayush interventions(AYUSH-64 &KabasuraKudineer) <br/ ><br>â?¢ Pregnant, lactating women and other vulnerable population <br/ ><br>â?¢ Use of immunosuppressive doses of corticosteroids prior to the enrollment in the study and planned use of immunosuppressive doses of corticoids <br/ ><br>â?¢ Any other condition that, in the opinion of the principal investigator or his/her representative physician, could put the safety of potential participants at risk or prevent them from complying with this protocol. <br/ ><br>â?¢ Patients who were diagnosed as having severe disease or receiving oxygen support. <br/ ><br>â?¢ People who are unable to take oral medication <br/ ><br>â?¢ People whose SpO2 levels are fluctuating within the range of 90-94. <br/ ><br>→ | Health Condition 1: B338- Other specified viral diseases
→ | Intervention1: AYSUH 64/Kabasura Kudineer: AYUSH 64- <br>Asymptomatic -2-0-2 for 20 days<br>Mild/moderate 2-2-2 for 20 days<br>Kabasura Kudineer<br>60 ml twice daily for 20 days<br>Control Intervention1: NA: NA<br>→ | â?¢ Demographic profiling of COVID 19 patients in home isolation, who received Ayush interventions(AYUSH 64 / Kabasurakudineer) as adjunct to standard care for asymptomatic, mild, and moderate COVID 19 in terms of geographic location, age, gender, education status, and domicile, based on the data reported through the Ayush Sanjivani appTimepoint: Day 1, Day 20→ | | | | Yes | False | | |
| → | CTRI/2021/05/033626 | 24 May 2021 | A study of Ayurvedic medicine â??CoReachâ?? in COVID-19 positive patients. | A prospective case control interventional study to assess safety and efficacy of proprietary Ayurvedic medicine Tab. â??CoReachâ?? in non-critical and antiviral naïve COVID-19 positive patients | | Questt Clinicals and Ayurceuricals Pvt Ltd | 17-05-2021 | 20210517 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54292 | Recruiting | No | | | | 18-05-2021 | 32 | Interventional | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Hrishikesh Rangnekar→ | | D 204, Second floor, Wing - D
Room no 204
Sun Planet,
Anand Nagar, Pune → | dr.rangnekar@gmail.com→ | 9890901109→ | Questt Clinicals and Ayurceuticals Pvt Ltd→ | Inclusion criteria: I. Patients with laboratory confirmation of infection with SARS CoV-2 by positive RT-PCR or Rapid Antigen Test with mild to moderate symptoms (Mild: Upper respiratory tract symptoms (& or fever) WITHOUT shortness of breath or hypoxia <br/ ><br>Moderate: Any one of: 1. Respiratory rate > 24/min, breathlessness 2. SpO2: 90% to < 93% on room air <br/ ><br>Ref: AIIMS ICMR-COVID-19 National Task Force) <br/ ><br>Patients progressing from moderate to severe grade during treatment will be withdrawn from the study <br/ ><br> <br/ ><br>II. Age >18 and < 75 years at the time of signing ICF <br/ ><br>III. Voluntarily participation in the clinical trial and agreeing to follow study procedures <br/ ><br>IV. Not participating in any other interventional drug clinical studies before completion of the present study <br/ ><br>V. Ready to give medical data for assessments <br/ ><br>→ | Exclusion criteria: I. Critical infection, defined as need for invasive ventilator support <br/ ><br>II. Inability to intake or tolerate oral medications. <br/ ><br>III. Known pregnant or lactating women <br/ ><br>IV. Persons with severe primary respiratory disease or other pneumonia <br/ ><br>V. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tab. CoReach: Tab. CoReach is a mixture of herbs which can be useful in treating Covid 19. Standard of care will be given in addition to the IP.<br>Control Intervention1: Standard of care: Standard of care as deemed fit by the treating physician. It might contain drugs like Tab. Favipiravir, Tab. Ivermectin and antibiotics like Tab. Azithromycin; and NSAIDs like Tab. Paracetamol. Dose: Standard adult dose of corresponding drugs. Route: Oral. Duration: 10 days.<br>→ | To assess percentage of patients with 2 points improvement or becoming asymptomatic (Grade 2 or less) on the modified ordinal scale for clinical improvementTimepoint: Day 4→ | | | | Yes | False | | |
| → | CTRI/2021/05/033651 | 24 May 2021 | A clinical study on Ayurveda intervention along with Standard Care Treatment in mild to moderate patients of COVID-19
| A randomised controlled clinical study on Ayurveda intervention (Ayush 64, Sanshamani Vati and Vatashleshma Jwarhar Kwatha) along with Standard Care Treatment in mild to moderate patients of COVID-19
| | Dr SR Rajasthan Ayurved University Jodhpur | 17-05-2021 | 20210517 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55951 | Not Recruiting | No | | | | 25-05-2021 | 30 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DR SANJAY SRIVASTAVA→ | | Department of Shalya Tantra, University College of Ayurveda, Room
Number 162, Dr. S.R. Rajasthan Ayurved University, Jodhpur,
Nagaur Road, Kadwad, Jodhpur
Jodhpur
RAJASTHAN
342037 → | vc.dsrrau@gmail.com→ | 8800543828→ | Dr. S.R. Rajasthan Ayurved University, Jodhpur→ | Inclusion criteria: 1. All hospitalized cases 18-60 years of age, clinically diagnosed with corona virus disease 2019 (Covid19) and who are symptomatic and having Mild to moderate symptoms. <br/ ><br>2. Participants who can take medicines orally. <br/ ><br>3. Patients taking standard care treatment <br/ ><br>4. Patients willing to provide signed informed consent. <br/ ><br>→ | Exclusion criteria: 1. Cases of severe vomiting which would affect oral administration of medicine difficult. <br/ ><br>2. Cases of respiratory failure and requiring mechanical ventilation. <br/ ><br>3. Patients having Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper range of normal limits. <br/ ><br>4. Patients with COVID-19 in critical condition or ARDS or NIAD 8 â??point ordinal score-2 (Hospitalized, on invasive mechanical Ventilation or extra corporeal membrane oxygenation <br/ ><br>5. Combined organ failure requiring ICU monitoring. <br/ ><br>6. Patients with uncontrolled Diabetes Mellitus, (HbA1c more than 8.0), Malignant Hypertension (systolic BP more than 180 and diastolic 110), Chronic Renal Failure and those on immunosuppressive medication. <br/ ><br>7. Patients with history of malignancy, IHD, CAD, triple vessel disease, history of CABG, Stroke, etc. <br/ ><br>8. Any other condition, which as per the investigator would jeopardize the outcome of the trial. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayush 64 capsule <br><br>Sanshamani Vati <br><br>Vatashleshma Jwarhar Kwatha: Ayush 64 capsule 2 Capsule thrice in a day<br><br>Sanshamani Vati 2 Tablet thrice in a day <br><br>Vatashleshma Jwarhar Kwatha, 20 ML Twice in a day<br>Control Intervention1: Allopathic Medicine: Standard Treatment<br>→ | 1. Clinical cure rate: Time to get a negative status of Covid-19. (defined as viral load of respiratory specimen negative for two consecutive times when tested in an interval of two days) [Time frame 1 month] <br/ ><br>2. Duration of fever and each of the respiratory symptoms [Time frame 1 month]. <br/ ><br>Timepoint: 4weeks <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/05/033665 | 24 May 2021 | A Clinical Study to Test the Side Effects and Antibody Levels after Hetero-COVID Vaccine in Healthy Adults | A Prospective, Randomized, Interventional, Parallel, Multi-Center, Comparative Clinical Trial to Evaluate the Safety and Immunogenicity of COVID-Vac Combined Vector Vaccine (Manufactured by Hetero) in Healthy Adult Human Subjects. | | Hetero Biopharma Limited | 18-05-2021 | 20210518 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56122 | Not Recruiting | No | | | | 24-05-2021 | 228 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3 | India→ | Dr Shubhadeep Sinha→ | | 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar → | sreenivasa.chary@heterodrugs.com→ | 04023704923→ | Hetero Labs Limited→ | Inclusion criteria: 1. Adult male or female volunteers aged 18-65 years (inclusive of both) who are not vaccinated for COVID-19/Influenza and willing to give written, signed and dated informed consent to participate in the study <br/ ><br>2. Negative immunoglobulin M (IgM) SARS-CoV-2 antibodies through enzyme immunoassay test result <br/ ><br>3. Negative COVID-19 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit <br/ ><br>4. No acute infections and/or respiratory diseases within 14 days before enrollment <br/ ><br>5. Negative human immunodeficiency virus (HIV 1 & 2), Syphilis, Hepatitis B and C test results→ | Exclusion criteria: 1. Any vaccination/immunization within 30 days before the enrollment <br/ ><br>2. Usage of Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products within 30 days before the enrollment <br/ ><br>3. Immunosuppressive therapy within 3 months before the enrollment <br/ ><br>4. Donated blood or plasma within 3 months before enrollment <br/ ><br>5. Neutropenia (absolute neutrophil count <1,000/mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin <80 g/L), immunodeficiency in the past 6 months before enrollment <br/ ><br>6. Participation in any other interventional clinical trial within 3 months <br/ ><br>7. Volunteer is pregnant or breast-feeding <br/ ><br>8. History or evidence of Tuberculosis or chronic systemic infections→ | | Intervention1: COVID-Vac Combined Vector Vaccine (manufactured by Hetero)<br>: Component I: Recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) Ñ? 10 power 11 particles per dose of 0.5 mL||<br>Component II: Recombinant adenovirus serotype 5 particles containing SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) Ñ? 10 power 11 particles per dose of 0.5 mL||<br>Component I and Component II will be given with a gap of 21 Days<br>Control Intervention1: Gam-COVID-Vac (Sputnik V â?? Manufactured for RDIF, Russia): Component I: Recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) Ñ? 10 power 11 particles per dose of 0.5 mL|| Component II: Recombinant adenovirus serotype 5 particles containing SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) Ñ? 10 power 11 particles per dose of 0.5 mL|| Component I and Component II will be given with a gap of 21 Days<br>→ | Geometric Mean Titre (GMT) Ratio of SARS-CoV-2 glycoprotein-specific antibodiesTimepoint: Day 28 and Day 42→ | | | | Yes | False | | |
| → | CTRI/2021/05/033703 | 24 May 2021 | A Clinical Study to Test the Effectiveness and Side Effects of Hetero-Tocilizumab in Severe COVID-19 Patients | A Phase-III, Multicenter, Prospective, Double Blind, Randomized, Parallel, Clinical Study Evaluating the Efficacy, Safety and Tolerability of Hetero-Tocilizumab in Cytokine Storm of Severe Coronavirus Disease (Covid-19) Pneumonia (TOCICOVID Study) | | Hetero Biopharma Limited | 20-05-2021 | 20210520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56095 | Not Recruiting | No | | | | 23-05-2021 | 188 | Interventional | Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded→Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3 | India→ | Dr Shubhadeep Sinha→ | | 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar → | sreenivasa.chary@heterodrugs.com→ | 04023704923→ | Hetero Labs Limited→ | Inclusion criteria: 1. Adult male and female (18-65 years age both inclusive) patients and willing to provide written informed consent. <br/ ><br>2. Hospitalized with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other commercial or public health assay in any specimen <br/ ><br>3. Patients with the severe COVID-19 defined as patients with clinical signs of pneumonia plus one of the following: respiratory rate >30 breaths/min and severe respiratory distress or SpO2 <90% on room air. <br/ ><br>4. Patients with elevated IL-6 ( >40 pg/ml), D-dimer >1.5 μgFEU /ml, Elevated CRP ( >75mg/L) and ferritin 5X ULN→ | Exclusion criteria: 1. Patients contraindicated or with history/ evidence of hypersensitivity to Tocilizumab or any of the components of formulation. <br/ ><br>2. Patients requiring intubation and mechanical ventilation <br/ ><br>3. Patients with ALT/AST â?¥ 5 x upper limit of normal (ULN) <br/ ><br>4. Patients with platelet counts <1,00,000/cmm or absolute neutrophil counts <2000/cmm <br/ ><br>5. Patients received oral anti-rejection or immunomodulatory drugs (including tocilizumab) within the past 3 months <br/ ><br>6. Patients of immunocompromised status or on immunosuppressive therapy (except for steroids for COVID only), advanced cancer <br/ ><br>7. Evidence of multiorgan failure <br/ ><br>8. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization <br/ ><br>9. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Hetero-Tocilizumab: Hetero-Tocilizumab 8mg/kg (maximum 800mg) once on Day 1. This is a single dose administration intravenously over 60 min infusion<br>Control Intervention1: RMP-Tocilizumab: RMP-Tocilizumab 8mg/kg (maximum 800mg) once on Day 1. This is a single dose administration intravenously over 60 min infusion<br>→ | Cumulative proportion of patients requiring mechanical ventilationTimepoint: Day 14→ | | | | Yes | False | | |
| → | CTRI/2021/05/033712 | 24 May 2021 | Challenges faced by hemodialysis patients in times of COVID- 19 Pandemic | Challenges Faced by Patients Undergoing Hemodialysis during COVID- 19 Pandemic: A Qualitative Study | | Kasturba Medical College Manipal | 20-05-2021 | 20210520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55864 | Not Recruiting | No | | | | 15-06-2021 | 10 | Observational | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ravindra Prabhu A→ | | Room Number 15, Department of Nephrology, Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal → | ravindra.prabhu@manipal.edu→ | 9448107771→ | Kasturba Medical College, Manipal Academy of Higher Education, Madhav Nagar, Manipal→ | Inclusion criteria: Patients undergoing in-center hemodialysis→ | Exclusion criteria: Subjects undergoing peritoneal dialysis <br/ ><br>Critically ill patients <br/ ><br>Pregnant Women <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: N186- End stage renal disease
→ | | Qualitative evaluation of hemodialysis patients experiences during COVID 19 pandemic. The outcomes will be presented as overall themes and subthemesTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/05/033693 | 24 May 2021 | A multi-center, Phase- III clinical trial of Molnupiravir capsules. | A prospective, randomized, parallel, multicentric, phase-III clinical trial of Molnupiravir 800 mg capsules and standard of care (SOC) compared to standard of care only in confirmed RT-PCR positive patients with mild COVID-19. - NOCOV | | NATCO Pharma Limited | 20-05-2021 | 20210520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55936 | Not Recruiting | No | | | | 24-05-2021 | 1218 | Interventional | Randomized, Parallel Group Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label→Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 3 | India→ | Dr Sandeep Singh→ | | Clinical Operations Department, Room Number 2, East Wing, Second Floor Skoda House Opposite L J Campus S G Highway Sarkhej Ahmedabad â?? 382210, Ahmadabad, GUJARAT-382210, India
→ | sandeep.singh@cbccusa.com→ | 9637555304→ | CBCC Global Research LLP→ | Inclusion criteria: 1. Patients willing and able to provide voluntary written informed consent and to <br/ ><br>follow the protocol requirements <br/ ><br> <br/ ><br>2. Male or female patients between 18 and 60 years of age (both inclusive) <br/ ><br> <br/ ><br>3. Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal and/or <br/ ><br>oropharyngeal swabs (sample collected â?¤5 days prior to randomization) <br/ ><br>Note: If rapid antigen test has been performed and patient found positive then <br/ ><br>RT-PCR will be performed prior to randomization <br/ ><br> <br/ ><br>4. Patients with mild COVID-19 and have following symptoms and signs prior <br/ ><br>to randomization <br/ ><br>Upper respiratory tract symptoms (&/or fever) without shortness of breath or <br/ ><br>hypoxia <br/ ><br> <br/ ><br>5. Patients who are able to consume oral medications <br/ ><br> <br/ ><br>6. Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ ><br>Refrain from donating sperm; and either abstain from sexual intercourse as <br/ ><br>their preferred and usual lifestyle (abstinent on a long term and persistent <br/ ><br>basis) and agree to remain abstinent; or must agree to use contraception <br/ ><br> <br/ ><br>7. Females who are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier <br/ ><br>method), or be abstinent from sexual intercourse as their preferred and usual <br/ ><br>lifestyle (abstinent on a long-term and persistent basis) for 28 days from the <br/ ><br>start of study intervention; a WOCBP must have a negative highly sensitive <br/ ><br>pregnancy test (urine or serum test is required) within 24 hours before the first <br/ ><br>dose of study intervention→ | Exclusion criteria: 1. Known hypersensitivity or contraindications to any of the components of the study interventions or to any other similar class of drugs as determined by the investigator <br/ ><br> <br/ ><br>2. Uncontrolled comorbid medical conditions <br/ ><br> <br/ ><br>3. SpO2 â?¤ 93% on room air and respiratory rate â?¥ 24/min and breathlessness <br/ ><br> <br/ ><br>4. Patient is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization <br/ ><br> <br/ ><br>5. Patient is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) <br/ ><br>equation <br/ ><br> <br/ ><br>6. If patient has any of the following conditions: human immunodeficiency virus (HIV); chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm3; autologous or allogeneic hematopoietic stem cell transplant recipient <br/ ><br> <br/ ><br>7. If patient has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening <br/ ><br> <br/ ><br>8. If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization <br/ ><br> <br/ ><br>9. Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis <br/ ><br> <br/ ><br>10. Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, Oseltamivir, Remdesivir or any other anti-viral treatments) during study participation as per investigatorâ??s discretion <br/ ><br> <br/ ><br>11. A baseline heart rate of < 60 beats per minute at rest <br/ ><br> <br/ ><br>12. If patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Molnupiravir 200mg capsules, (4 x 200mg), twice a day for 5 days before food intake.: Standard of care<br>Control Intervention1: Standard of Care: Ivermectin 12mg, oral tablet, once daily for 5 days after food intake. Symptomatic medication including anti-pyretic,<br>anti-tussive and multivitamins, Empiric antimicrobials<br>→ | To evaluate the efficacy of Molnupiravir compared to standard of care in confirmed RT-PCR positive patients with mild COVID-19.Timepoint: Rate of hospitalization from randomization up to Day 14.→ | | | | Yes | False | | |
| → | CTRI/2021/05/033696 | 24 May 2021 | Emergency management of low oxygen level using ayurved formulation with special referemce to SPO2 | Efficacy of Ayurved Formulation in the emergency management of COVID19 positive patients with special reference to SPO2 level-Prospective open label multicentric clinical study | | Dr Abhijit Ahire | 20-05-2021 | 20210520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56026 | Not Recruiting | No | | | | 25-05-2021 | 30 | Interventional | Other
Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label→Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Open Label | Phase 3 | India→ | Dr Abhijit Ahire→ | | Vazirabad,Nanded Vazirabad,Nanded→ | kulk.prasad1@gmail.com→ | | Govt Ayurved College ,Nanded→ | Inclusion criteria: Age- 16 to 70 years <br/ ><br>2. SpO2 less than 85 % or having continues O2 supply greater than 8 lit/min <br/ ><br>3. HRCT score â?¥ 10 or above→ | Exclusion criteria: 1) Subjects having critical illness. <br/ ><br>2) subjects having SPo2 above 85 % or having continuous 02 supply less than 8 lit/min.. <br/ ><br>3) Subjects not willing for trial. <br/ ><br>4) Pregnant females and lactating mothers→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Hemgarbhapottali Ras: dose-125mg half hourly for 3 to 6 hrs for one day by oral route<br>Control Intervention1: Nil: nil<br>→ | SPo2 level increases with intervention of Ayurved formulation as per the dose scheduleTimepoint: half hour to 6 hours→ | | | | Yes | False | | |
| → | CTRI/2021/05/033695 | 24 May 2021 | Role of Kankasav in the management of spo2 level of covid 19 patients | ROLE OF KANAKASAV IN THE MANAGEMENT OF COVID-19 PATIENT WITH SPECIAL REFERENCE TO ARTERIAL BLOOD OXYGEN LEVEL (SpO2)-PROSPECTIVE OPEN LABELLED MULTICENTRIC CLINICAL STUDY | | DrPrasad Kulkarni | 20-05-2021 | 20210520 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56031 | Not Recruiting | No | | | | 25-05-2021 | 30 | Interventional | Other
Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Open Label→Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Open Label | Phase 3 | India→ | DrAbhijit Ahire→ | | Room no 12,Dept of panchakarma ,Govt Ayurved College ,Nanded → | abhijitahire@gmail.com→ | 7774048512→ | Govt Ayurved Hospital Nanded→ | Inclusion criteria: Subjects with positive rapid antigen test OR RT-PCR â?? reverse transcription polymerase chain reaction with blood oxygen saturation (SpO2) â?¥ 85 up to 94 HRCT score â?¥7 or above <br/ ><br> <br/ ><br>Subjects having at least any one of the diagnostic criteria. <br/ ><br>Patient between age group 20-70 years of age. <br/ ><br> Patients of any gender, and willing for trial. <br/ ><br> Irrespective of socioeconomic condition of patient. <br/ ><br>→ | Exclusion criteria: 1) Subjects having critical illness. <br/ ><br>2) subjects having SPo2 below 85. <br/ ><br>3) Subjects not willing for trial. <br/ ><br>4) Pregnant females and lactating mothers. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Kankasav: This is ayurvedic formulation given 15 ml thrice a day for 5 days<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | SPo2 level of patients are increased and dyspnoea reducedTimepoint: 2 to 3 weeks→ | | | | Yes | False | | |
| KCT0006152 | 24 May 2021 | Feasibility of detection of COVID-19 in Self-Obtained Oral Sample. | Feasibility of detection of COVID-19 in Self-Obtained Oral Sample. | | Korea Cancer Center Hospital | 2021-05-20 | 20210520 | CRIS | https://cris.nih.go.kr/cris/search/detailSearchEn.do?seq=19307 | Not Recruiting | No | 20?(Year) | No Limit | Both | 2021-05-03 | 34 | Interventional Study | Primary Purpose : Diagnosis, Intervention Model : Single Group, Blinding/Masking : Open, Allocation : Not Applicable | Not applicable | Korea, Republic of | Dong Ryung | Shin | 75 Nowon-ro, Nowonb-gu, Seoul, Korea | shindongryung@kirams.re.kr | +82-2-970-1651 | Korea Cancer Center Hospital | Inclusion criteria: 34 patients who are already diagnosed as having COVID-19 and admitted for close observation | Exclusion criteria: 1. those who have physical handicap to take self oral sample
<br>2. those who have severe disease and uncoscious using respriatory assist in intensive care unit
<br>3. those who are determined by physician not able to perform self-sampling | ;Diseases of th respiratory system | Medical Device : Difference of COVID-19 virus between self-obtained oral sample using self sampling device, G+, and physician obtained sample | Difference of detection of SARS-Cov-2 between self-obtained oral sample and physician obtained sample | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| IRCT20180612040068N1 | 26 May 2021 | To study the effect of Metronidazole and Ivermectin in hospitalized patients with COVID-19. | To study the effect of Metronidazole and Ivermectin in the recovery of the infected patients with COVID-19 compared with protocol treatment: triple-blind randomized clinical trial | | Shiraz University of Medical Sciences | 2021-04-19 | 20210419 | IRCT | http://en.irct.ir/trial/54625 | Not Recruiting | No | 18 years | no limit | Both | 2021-03-05 | 135 | interventional | Randomization: Randomized, Blinding: Triple blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Permuted block random allocation
Three therapies and six houses blocks
In each step when a new block is selected, we select one of the 6 blocks by rolling the dice, Blinding description: Both Ivermectin and Metronidazole, and the control group's drug are labeled as A, B and C, and are unknown to the patient and therapist (Allocation Concealment). Prescription of the medicine to the patients in each group will be ordered by a third person, preferably an epidemiologist. | 3 | Iran (Islamic Republic of) | Hassan Joulaei | | School of Medicine, Zand Blvd., Health policy Research Center | joulaei_h@yahoo.com | +98 71 3230 5410 | Shiraz University of Medical Sciences | Inclusion criteria: Hospitalized patient with positive corona test | Exclusion criteria: Allergic history to Metronidazole or Ivermectin or hypersensitivity reaction to them during trial.<br>pregnant patients<br>COPD<br>Patients suspected to ILD<br>long history of diabetes<br>cirrhotic patients<br>Epileptic patients<br>patients with sever renal failure ang GFR below 20<br>participating in another RCT | Coronavirus infection. <br>Coronavirus infection, unspecified;B34.2 | Intervention 1: The first intervention group is the patients that will intake 0.2 mg / kg body weight daily Ivermectin orally (3 mg tablets) as a single dose. Intervention 2: Control group will receive only standard treatment. ( protocol-based drugs) Medication does not interfere with meals. Intervention 3: The second intervention group is the patients that will intake 8 mg/kg body weight of metronidazole up to a maximum of 500 mg every 12 hours for 7 days. | The main consequences of this trial including; the time of disappearance of shortness of breath, the need for oxygen, the reduction of CRP, the normalization of lymphopenia that will be measured by specialists. Also, the effectiveness of each treatment method will be measured based on the length of hospital stay, the likelihood of hospitalization in the ICU, and the likelihood of mortality. Timepoint: Before starting treatment and at the time of discharge, which should not be less than 5 days. Method of measurement: Blood factors with laboratory methods. Temperature with digital thermometer. Blood pressure with mercury sphygmomanometer or digital pulse oximeter. Other cases with direct observation. | | | | No | False | | |
| → | IRCT20180103038199N4 | 26 May 2021 | Effect of Basil on outpatients with COVID-19 | Evaluation of the effectiveness of complementary therapy with Basil (Ocimum basilicum) capsule on the clinical symptoms of outpatients with COVID-19 | | Mashhad University of Medical Sciences | 2021-04-24 | 20210424 | IRCT | http://en.irct.ir/trial/54965 | Recruiting | No | 18 years | 60 years | Both | 2021-04-30 | 140 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The volume of each block will be 4. Then write a list of blocks and assign numbers to them, for example (AABB (1) - BBAA (2) - BABA (3) - BAAB (4)) which according to the sample size of 140 people, we have 35 blocks. Then, random numbers between one and 35 are selected according to the Randomaize.com randomization site, and finally, the treatment allocation list is determined based on random numbers, Blinding description: Due to the use of a placebo similar to interventional therapy, the physician associated with the participants and participants will not be informed of the assigned treatment and also the analyst will be unaware of the treatment assigned to the two groups. Finally, after analyzing the data, the researcher who prepared the packages reveals codes A and B. | 2-3 | Iran (Islamic Republic of) | Dr Vahid Reza Askari | | Faculty of Medicine, Azadi sq, Mashhad | askariv@mums.ac.ir | +98 915 371 9688 | Mashhad University of Medical Sciences | Inclusion criteria: Outpatients with COVID-19<br>Confirmed with RT-PCR<br>SPO2 more than 90%<br>Age between 18 to 60 years old | Exclusion criteria: Pregnant women<br>Breastfeeding women | COVID-19 disease. <br>COVID-19;U07.1 | Intervention 1: Control group: Receive common treatments based on the ministry of health protocol + placebo capsules (Avicell) made in Mashhad school of Persian and complementary medicine twice a day for 10 days. Intervention 2: Intervention group: Receive common treatments based on the ministry of health protocol + capsules containing 300 mg of basil extract made in Mashhad school of Persian and complementary medicine 2 times a day for 10 days. | Normalization of CRP and lymphopenia. Timepoint: before the intervention and 14 days after The beginning the intervention. Method of measurement: laboratory.;Time to recover from illness based on questionnaire. Timepoint: before intervention and 3, 7 and 14 days after beginning the intervention. Method of measurement: questionnaire.→Time to recover from illness based on questionnaire. Timepoint: before intervention and 3, 7 and 14 days after beginning the intervention. Method of measurement: questionnaire.;Normalization of CRP and lymphopenia. Timepoint: before the intervention and 14 days after The beginning the intervention. Method of measurement: laboratory. | | | | Yes | False | | |
| IRCT20200611047727N4 | 26 May 2021 | Evaluation of the effect of high flow oxygen delivery under different temperatures in COVID-19 patients | The effectiveness of oxygen delivery through high flow nasal cannula (HFNC) with different temperatures in improving the clinical symptoms of COVID-19 patients | | Shahid Beheshti University of Medical Sciences | 2021-04-28 | 20210428 | IRCT | http://en.irct.ir/trial/55024 | Recruiting | No | 18 years | no limit | Both | 2021-04-19 | 30 | interventional | Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: With simple randomization and using random number table and individual randomization unit. For randomization, we use a table consisting of random digits 1 to 9. Each digit of this table is repeated the same on average. There is no pattern of recognizable numbers. In this method, each figure is assigned to a treatment group. We start from the first row of the table and move from row to row. For the three treatments, we put the numbers 1 to 3 for treatment A, the numbers 4 to 6 for treatment B, and the numbers 7 to 9 for treatment C. We will continue the above process until the two groups are completed, Blinding description: To prevent any possible complications, the doctor and clinical caregiver are fully aware of the specificity of the treatment groups. Patients in the study were also not blinded to the type of treatment they were receiving. | 2 | Iran (Islamic Republic of) | Maryam Sadat Mirenayat | | Masih Daneshvari Hospital, Darabad | mirenayat_m@yahoo.com | +98 21 2610 5050 | Shahid Beheshti University of Medical Sciences | Inclusion criteria: New coronavirus detection (clinical or paraclinical)<br>Oxygen saturation less than 90%<br>Written consent to participate in the study<br>Age over 18 years<br>Moderate to severe Covid-19 disease is hospitalized and requires respiratory support | Exclusion criteria: PaCO2>65<br>PH<7.28<br>Cardiovascular disorders that prevent pulmonary rehabilitation | COVID-19. <br>COVID-19;U07.01 | Intervention 1: First intervention group: In this group, patients undergo oxygen therapy with a high-flow device for "24 hours". This device transmits hot and humid air with high flow (up to 60 l / min) through the nasal cannula to patients. Temperature and flow are adjustable. In this group of patients, the temperature of the air transferred to the patient is set at 31 ° C. Intervention 2: Second intervention group: In this group, patients undergo oxygen therapy with a high-flow device for "24 hours". This device transmits hot and humid air with high flow (up to 60 l / min) through the nasal cannula to patients. Temperature and flow are adjustable. In this group of patients, the temperature of the air transferred to the patient is set at 34 ° C. Intervention 3: Third intervention group: In this group, patients undergo oxygen therapy with a high-flow device for "24 hours". This device transmits hot and humid air with high flow (up to 60 l / min) through the nasal cannula to patients. Temperature and flow are adjustable. In this group of patients, the temperature of the air transferred to the patient is set at 37 ° C. | Oxygen saturation. Timepoint: Before starting oxygen therapy, 24 hours later. Method of measurement: Pulse oxymetry.;Partial pressure of carbon dioxide. Timepoint: Before starting oxygen therapy, 24 hours later, 7 days later. Method of measurement: VBG analysis.;Interleukin 6. Timepoint: Before starting oxygen therapy, 24 hours later, 7 days later. Method of measurement: Laboratory tests.;C-Reactive Protein. Timepoint: Before starting oxygen therapy, 24 hours later, 7 days later. Method of measurement: Laboratory tests.;Erythrocyte Sedimentation Rate. Timepoint: Before starting oxygen therapy, 24 hours later, 7 days later. Method of measurement: Laboratory tests.;Ferritin. Timepoint: Before starting oxygen therapy, 24 hours later, 7 days later. Method of measurement: Laboratory tests. | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04340557 | 7 June 2021 | Do Angiotensin Receptor Blockers Mitigate Progression to Acute Respiratory Distress Syndrome With SARS-CoV-2 Infection | Randomized Open Label Study of Standard of Care Plus an Angiotensin II Receptor Blocker Compared to Standard of Care Alone to Minimize the Progression to Respiratory Failure in SARS-CoV-2 Infection | | Sharp HealthCare | 06/04/2020 | 20200406 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04340557 | Not recruiting | No | 18 Years | N/A | All | March 27, 2020 | 31 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 4 | United States | | Matthew Geriak, PharmD | | | | Sharp HealthCare |
<br> Inclusion Criteria:
<br>
<br> - Confirmed COVID-19 positive test result
<br>
<br> - Mild to moderate respiratory symptoms of COVID-19.
<br>
<br> - Systolic blood pressure = 105 mmHg.
<br>
<br> - Screen within 3 days of a positive COVID-19 test.
<br>
<br> - Age =18 years old.
<br>
<br> - Access to a phone in the hospital room or an electronic device that is capable of
<br> receiving phone or video calls.
<br>
<br> - Able to read/write/speak English or Spanish fluently.
<br>
<br> - Subjects must have the capacity to provide consent or an appropriate LAR to provide
<br> informed consent.
<br>
<br> - Negative pregnancy test for women of childbearing potential and subject is randomized
<br> to the study arm.
<br>
<br> Exclusion Criteria:
<br>
<br> - Severe allergy to any ARB or ACE-inhibitor, including angioedema
<br>
<br> - In the intensive care unit at screening.
<br>
<br> - Home meds include any kind of ACE inhibitor or ARB
<br>
<br> - Acute Kidney Injury (50% reduction in GFR from baseline at admission to any time
<br> during treatment in the study treatment arm)
<br>
<br> - Hyperkalemia >5.0 mmol/L at baseline or any time during treatment in the study
<br> treatment arm
<br>
<br> - Creatinine Clearance < 30 ml/min at baseline or any time during treatment in the study
<br> treatment arm
<br> | | SARS-CoV Infection | Drug: Losartan | Mechanical Ventilation | 26/05/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04340557 | Yes | False | | Yes |
| → | NCT04342884 | 7 June 2021 | COVID-19 Community Research Partnership | A Multicenter, Prospective Study of COVID-19 Using Real-Time Syndromic Surveillance, Scheduled At-home Serologic Testing, and Electronic Health Records | | Wake Forest University Health Sciences | 08/04/2020 | 20200408 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04342884 | Recruiting | No | N/A | N/A | All | April 8, 2020 | 150000 | Observational | | | United States | ; | John W Sanders, MD, MPH&TM;Wake Forest Baptist Medical Center | | ;jwsander@wakehealth.edu | ;336-70-COVID | Wake Forest University Health Sciences; |
<br> Inclusion Criteria:
<br>
<br> - All clients and health care worker of WFBH are eligible for enrollment.
<br>
<br> Exclusion Criteria:
<br>
<br> - Health care workers who do not receive medical services through WFBH will not be
<br> enrolled.
<br> | | Coronavirus;COVID | | Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina;Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina→Seroprevalence of SARS-CoV-2 infection among health care workers of North Carolina;Seroprevalence of SARS-CoV-2 infection in the general population of North Carolina | | | | Yes | False | | |
| NCT04352556 | 7 June 2021 | COVID19-hematological Malignancies: the Italian Hematology Alliance | SARS-CoV-2 Infection in Patients With Hematological Malignancies: the Italian Hematology Alliance | | Ospedale di Circolo - Fondazione Macchi | 09/04/2020 | 20200409 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04352556 | Recruiting | No | 18 Years | N/A | All | April 7, 2020 | 250 | Observational | | | Italy | ; | Francesco Passamonti, MD;Francesco Passamonti, MD | | ;francesco.passamonti@asst-settelaghi.it | ;+39-0332-393648 | Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi, Varese, Italy; |
<br> Inclusion Criteria:
<br>
<br> - Age equal to or greater than 18 years of age.
<br>
<br> - History of hematological malignancies (acute leukemias, myelodysplastic syndromes,
<br> myeloproliferative neoplasms, lymphomas, myeloma).
<br>
<br> - Active hematological malignancies (acute leukemias, myelodysplastic syndromes,
<br> myeloproliferative neoplasms, lymphomas, myeloma) at any stage/status.
<br>
<br> - SARS-CoV-2 positive test (nasopharyngeal, BAL, fecal), documented by Real-Time Reverse
<br> Transcriptase (RT)-PCR Diagnostic Panels.
<br>
<br> Exclusion Criteria:
<br>
<br> - Hematological diseases, other than hematological malignancies.
<br>
<br> - SARS-CoV-2 negative test.
<br> | | SARS-CoV-2 Infection;Hematological Malignancies | | To evaluate COVID severity as predictive parameter of mortality.;To evaluate potential predictive HM-related parameters of mortality.;To evaluate potential predictive biochemical parameters of mortality.;To evaluate mortality. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04416893 | 7 June 2021 | Part 2 on the Study Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children (COVILLE2) (WHO) | Prevalence of SARS -Cov2 Carriage in Asymptomatic and Mildly-symptomatic Children, a Cross-sectional, Prospective, Multicentre, Observational Study in Primary Care-Part 2 After the Lifting of the Lockdown | COVILLE2 | Centre Hospitalier Intercommunal Creteil | 02/06/2020 | 20200602 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04416893 | Not recruiting | No | N/A | 15 Years | All | November 2020 | 0 | Observational | | | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Birth to 15 years old
<br>
<br> - taking over the community (kindergarten, school, college, holiday centre, etc.) for at
<br> least 1 week
<br>
<br> Exclusion Criteria:
<br>
<br> - refusal to participate
<br> | | COVID19 | Diagnostic Test: RT-PCR SARS-Cov2;Diagnostic Test: Sars-Cov2 serology | Proportion of asymptomatic children or children with mild respiratory symptoms | | | | Yes | False | | |
| → | NCT04419025 | 7 June 2021 | Efficacy of N-Acetylcysteine (NAC) in Preventing COVID-19 From Progressing to Severe Disease | Determination of Efficacy of N-Acetylcysteine in Preventing Those With Mild or Moderate COVID-19 From Progressing to Severe Disease | | Cambridge Health Alliance | 03/06/2020 | 20200603 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04419025 | Not recruiting | No | 18 Years | N/A | All | September 23, 2020 | 165 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - known or suspect COVID-19 disease AND one or more of the following influenza-like
<br> symptoms, including: diarrhea vomiting fever (subjective or measured) chills myalgias
<br> fatigue sore throat headache cough nasal/sinus congestion or rhinorrhea shortness of
<br> breath chest pain
<br>
<br> Exclusion Criteria:
<br>
<br> - Minors, pregnant women and people unable to provide informed consent are excluded from
<br> this study
<br> | | COVID;Sars-CoV2;SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere;Oxidative Stress | Drug: N-acetylcysteine | Recovery disposition;Need for hospitalization;Length of time intubated;Need for mechanical ventilation;Hospital length of stay (LOS);Decrease in Respiratory Rate→Decrease in Respiratory Rate;Hospital length of stay (LOS);Need for mechanical ventilation;Length of time intubated;Need for hospitalization;Recovery disposition | | | | Yes | False | | |
| NCT04419610 | 7 June 2021 | RAS and Coagulopathy in COVID19 | Investigating the Relationship Between the Renin Angiotensin System and the Coagulopathy Associated With COVID-19 | | Imperial College London | 16/04/2020 | 20200416 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04419610 | Not recruiting | No | 18 Years | N/A | All | October 9, 2020 | 30 | Interventional | Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: Double (Participant, Investigator). | Early Phase 1 | United Kingdom | ; | DAVID OWEN;Katrina Pollock | | ; | ; | National Health Service, United Kingdom;National Health Service, United Kingdom |
<br> INCLUSION CRITERIA
<br>
<br> A subject will be eligible for inclusion in this study only if all of the following
<br> criteria apply at the time of screening:
<br>
<br> 1. Hospitalised with confirmed COVID-19 infection.
<br>
<br> 2. Screened within 96hrs of SARS-COV-2 positive PCR.
<br>
<br> 3. Age 18 or over
<br>
<br> 4. Capable of giving written informed consent, which includes compliance with the
<br> requirements and restrictions listed in the consent form.
<br>
<br> 5. Systolic blood pressure between 100 and 180
<br>
<br> EXCLUSION CRITERIA
<br>
<br> A subject will not be eligible for inclusion in this study if any of the following criteria
<br> apply at the time of screening:
<br>
<br> 1. Any unrelated clinical condition, which, in the opinion of the investigator, may
<br> affect D-dimer during the course of the study, independent of COVID-19 infection, e.g.
<br> subsets of cancers and coagulopathies.
<br>
<br> 2. Concomitant medication which inhibit the action of TRV027 (ARB's).
<br>
<br> 3. Any clinically significant medical conditions that in the opinion of the investigator
<br> would compromise subjects' safety or compliance with study procedures.
<br>
<br> 4. Any clinical condition which in the opinion of the principal investigator would
<br> compromise the scientific integrity of the study
<br>
<br> 5. Unwillingness or inability to follow the procedures outlined in the protocol.
<br>
<br> 6. Subject is pregnant or breastfeeding
<br> | | COVID | Biological: TRV027;Other: sodium chloride 0.9% | Coagulopathy associated with COVID-19 | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04750330 | 7 June 2021 | Mitochondrial DNA and Nuclear SNPs to Predict Severity of COVID-19 Infection | Mitochondrial DNA and Nuclear SNPs to Predict Severity of COVID-19 Infection | mtDNA-COVID | Maastricht University | 26/01/2021 | 20210126 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04750330 | Recruiting | No | 18 Years | N/A | All | April 1, 2021 | 600 | Observational | | | Italy;Greece;Belgium;Italy;Greece;Belgium | ; | Philippe Lambin, Prof. Dr.;Cary Oberije, Dr. | | ;c.oberije@maastrichtuniversity.nl | ;+31433883549 | Head of Department of Precision Medicine, Maastricht University; |
<br> Inclusion Criteria:
<br>
<br> - Confirmed COVID-19 disease
<br>
<br> - Age at least 18 years
<br>
<br> - Willing and able to provide a saliva sample
<br>
<br> - Able to understand the patient study information
<br>
<br> - Signed informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> Exclusion criteria for hospitalized patients
<br>
<br> - Severe illness other than COVID-19 at hospital admission Exclusion criteria for
<br> non-hospitalized patients
<br>
<br> - Severe COVID-19 illness leading to death or requiring active treatment without
<br> hospital admission
<br> | | Covid19 | | COVID-19 Severity | | | | Yes | False | | |
| → | NCT04753476 | 7 June 2021 | Treatment of Severe COVID-19 Patients Using Secretome of Hypoxia-Mesenchymal Stem Cells in Indonesia | The Effect of Secretome of Hypoxia-Mesenchymal Stem Cells in Improving Survival of Severe Covid-19 Patients | | Stem Cell and Cancer Research Indonesia | 11/02/2021 | 20210211 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04753476 | Recruiting | No | N/A | N/A | All | June 8, 2020 | 48 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | Indonesia | ; | Agung Putra, Assoc.Prof;Agung Putra, Assoc.Prof | | ;dr.agungptr@gmail.com | ;+628164251646 | Stem Cell and Cancer Research Indonesia; |
<br> Inclusion Criteria:
<br>
<br> 1. Patients whose clinical and laboratory test results have a positive diagnosis of
<br> Covid-19.
<br>
<br> 2. Patients who are willing to participate as subjects in the study by signing the
<br> informed content.
<br>
<br> 3. Criteria for Berlin to enter ARDS (moderate and severe) with or without a ventilator:
<br>
<br> - PaO2 / FiO2: moderate 100-200
<br>
<br> - PaO2 / FiO2: severe <100
<br>
<br> 4. One or more comorbid history
<br>
<br> 5. SOFA score
<br>
<br> Exclusion Criteria:
<br>
<br> 1. The Covid19 patient has fibrosis (based on the results of the chest X-ray or CT chest)
<br>
<br> 2. ECOG 4 performance status, decreased irreversible consciousness, brain stem death.
<br>
<br> 3. Severe NYHA III / IV heart failure
<br>
<br> 4. Pregnant women
<br> | | Covid-19;Cytokine Storm | Biological: Injection of Secretome-MSCs;Drug: Standard treatment of Covid-19 | Photo thorax;Blood Gas Analisis (BGA);D-dimer;CRP;Routine blood profile;Length of stay;Duration of using a ventilator;Need for a ventilator;Change in patients clinical manifestation→Blood Gas Analisis (BGA);Photo thorax;D-dimer;CRP;Routine blood profile;Length of stay;Duration of using a ventilator;Need for a ventilator;Change in patients clinical manifestation | | | | No | False | | |
| NCT04758299 | 7 June 2021 | Understanding Communications Included With COVID-19 (Corona Virus Disease of 2019) Home Testing Kits | At Home Self-testing Kits for SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) : A Randomized Trial Assessing How Consumers Interpret and Act on Test Results | | Barry Dewitt | 12/02/2021 | 20210212 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04758299 | Not recruiting | No | 18 Years | N/A | All | March 13, 2021 | 360 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Investigator). | N/A | United States | ; ; ; | Barry Dewitt;Steven Woloshin, MD;Tamar Krishnamurti, PhD;Baruch Fischhoff, PhD | | ;;; | ;;; | Carnegie Mellon University;Dartmouth College;University of Pittsburgh;Carnegie Mellon University |
<br> Inclusion Criteria:
<br>
<br> - Participants must be >18 years old, communicate in English, reside in the United
<br> States.
<br>
<br> Exclusion Criteria:
<br>
<br> - Respondents who complete the survey in under a minute.
<br> | | COVID-19 Testing;Decision Making | Other: decision science-based design | choice of action to take with negative test | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| ACTRN12621000538842 | 7 June 2021 | COVID-19 Vaccine Efficacy in patients with Blood Cancer | COVID-19 Vaccine Efficacy in patients with Haematological Malignancy | | Royal Brisbane and Women's Hospital | 06/05/2021 | 20210506 | ANZCTR | https://anzctr.org.au/ACTRN12621000538842.aspx | Recruiting | No | 18 Years | No limit | Both males and females | 06/04/2021 | 50 | Observational | Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective; | Not Applicable | Australia | | | | | | | Inclusion criteria: 1. Greater than or equal to 18 years of age
<br>2. Able to provide voluntary informed consent
<br>3. Planned receipt of a COVID19 vaccine of any variety; e.g. Pfizer-BioNTech BNT162b2, AstraZeneca Oxford ChAdOx1 nCoV-19 (AZD1222), Novavax NVX-CoV2373 or ModernaTX mRNA-1273 vaccine.
<br>- Patients who have any haematological malignancy and received treatment with a B-cell targeted therapy or who have received a bone marrow transplant may be recruited to Cohort A.
<br>- Patients who do not have a diagnosis of a haematological malignancy or any other active cancer, and who have not received treatment with B cell depleting antibodies will be recruited to Cohort B. 50 patients will be recruited in total, 30 to Cohort A and 20 to Cohort B. | Exclusion criteria: 1. Current diagnosis of and/or treatment for a non-haematological malignancy.
<br>2. Receipt of B cell targeted therapies for Rheumatological or other non-haematological malignancy indication
<br>3. Unable to provide voluntary informed consent | Haematological Malignancy
;Bone Marrow Transplant;COVID-19; <br>Haematological Malignancy<br> <br>Bone Marrow Transplant <br>COVID-19;Cancer - Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma;Cancer - Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma;Cancer - Myeloma;Cancer - Hodgkin's;Cancer - Leukaemia - Acute leukaemia;Cancer - Leukaemia - Chronic leukaemia | Immune responses to COVID-19 vaccination.<br>Five blood samples will be collected from one week prior to first vaccination until six months after the second vaccination dose. Specifically the samples are collected at the following timepoints;<br>1) Prior to 1st COVID-19 vaccination dose (up to 1 week prior and until immediately before the first dose) <br>2) 72 hours prior to or after 2ndCOVID-19 vaccination dose<br>3) 14-18 days (+/- 2 days) after 2ndCOVID-19 vaccination dose<br>4) 4-6 weeks (+/- 1 week) after 2ndCOVID-19 vaccination dose<br>5) 6 months (+/- 2 weeks) after 2ndCOVID-19 vaccination dose <br>Medical information regarding diagnosis and treatment will also be collected, and will include inquiring about any subsequent COVID-19 infection for 12 months after the second vaccination.<br>30 patients who have received treatment with B cell depleting therapies or bone marrow transplantation will be recruited from within cancer care populations and a control group of 20 patients without a cancer diagnosis or treatment will also be recruited. | To characterise cellular responses to SARS-CoV-2 vaccination in patients who have received treatments for haematological malignancies targeting specific immune cells, B Cells, and those who have undergone bone marrow transplantation. A group of healthy controls will also be included for comparison.[Final blood sample collection occurs 6 months after final COVID-19 vaccination.<br>The collection schedule for all samples is as follows;<br>1) Prior to 1st COVID-19 vaccination dose (up to 1 week prior and until immediately before the first dose) <br>2) 72 hours prior to or after 2nd COVID-19 vaccination dose<br>3) 14-18 days (+\- 2 days) after 2nd COVID-19 vaccination dose<br>4) 4-6 weeks (+\- 1 week) after 2nd COVID-19 vaccination dose<br>5) 6 months (+\- 2 weeks) after 2nd COVID-19 vaccination dose];To characterise humoral responses to SARS-CoV-2 vaccination in patients with blood cancers treated with B cell targeted therapies and bone marrow transplantation. <br>[Final blood sample collection occurs 6 months after final COVID-19 vaccination.<br>The collection schedule for all samples is as follows;<br>1) Prior to 1st COVID-19 vaccination dose (up to 1 week prior and until immediately before the first dose) <br>2) 72 hours prior to or after 2nd COVID-19 vaccination dose<br>3) 14-18 days (+\- 2 days) after 2nd COVID-19 vaccination dose<br>4) 4-6 weeks (+\- 1 week) after 2nd COVID-19 vaccination dose<br>5) 6 months (+\- 2 weeks) after 2nd COVID-19 vaccination dose] | | | | No | False | | |
| → | ACTRN12621000532808 | 7 June 2021 | Vaccination of kidney transplant and dialysis patients and their close household contacts against COVID-19 | Immunogenicity of the ChAdOx1 nCoV-19 (Oxford-AstraZeneca) and the BNT162b2 (Pfizer) COVID-19 Vaccines in a South Australian Cohort of Immunocompromised Patients and their Close Household Contacts | | Central Adelaide Local Health Network | 06/05/2021 | 20210506 | ANZCTR | https://anzctr.org.au/ACTRN12621000532808.aspx | Recruiting | No | 18 Years | No limit | Both males and females | 01/04/2021 | 200 | Interventional | Purpose: Prevention; Allocation: Non-randomised trial; | Not Applicable | Australia | | | | | | | Inclusion criteria: For patient group:
<br>Have a current kidney transplant >3 months or currently on dialysis.
<br>Have a close household contact able to participate. | Exclusion criteria: For patient group:
<br>Prior exposure to SARS-CoV-2 (positive serology).
<br>Have previously received a COVID-19 vaccination.
<br>Due to receive a transplant within the ensuing 6 months.
<br>
<br>Control/comparison group:
<br>Prior exposure to SARS-CoV-2 (positive serology).
<br>Have previously received a COVID-19 vaccination. | Kidney Transplant;Dialysis; <br>Kidney Transplant <br>Dialysis;Renal and Urogenital - Other renal and urogenital disorders | Immune responses in kidney transplant and dialysis patients are compared in each case with that of a close household contact (usually a spouse) over the age of 18.<br><br>This study is interventional in so much as close household contacts of transplant and dialysis patients will, in some instances, receive their vaccinations earlier than they otherwise would.<br><br>Both patients and cohabitants will be asked to provide up to four blood samples starting prior to-, and then up to 6 months post-, receipt of the initial ChAdOx1 nCoV-19 (Oxford-AstraZeneca) or BNT162b2 (Pfizer-BioNTech) COVID-19 vaccine. Blood samples will be collected at the Royal Adelaide Hospital by trained staff. Samples for some participants will be collected at the Queen Elizabeth Hospital or at SA Pathology collection centres as dictated by convenience. <br><br>Number and timing of vaccine doses received will not differ from that of the rest of the population i.e. an initial and booster dose, 21 days apart in the case of Pfizer-BioNTech and 12 weeks apart in the case of Oxford-AstraZeneca.<br><br>Participants will also be asked to provide a one-off stool sample prior to vaccination using a provided at-home collection kit. In conjunction with this, participants will be asked to complete a four-day food diary.<br><br>Participation in this study will amount to four appointments for blood collection, and two visits to vaccination clinics. | Capacity of serum to neutralise SARS-CoV-2 spike protein-expressing pseudovirus will be assessed by a pseudovirus neutralisation assay.[Prior to initial vaccine dose, 20 days post initial vaccine dose, 20 days post vaccine booster dose (primary timepoint), 26 weeks post vaccine booster dose.];Detectable seroconversion of IgG against SARS-CoV-2 spike protein and receptor-binding domain will be assessed by enzyme-linked immunosorbent assay. [Prior to initial vaccine dose, 20 days post initial vaccine dose, 20 days post vaccine booster dose (primary timepoint), 26 weeks post vaccine booster dose.];SARS-CoV-2 spike protein-specific T cell response will be assessed by IFN-gamma ELISpot. [Prior to initial vaccine dose, 20 days post initial vaccine dose, 20 days post vaccine booster dose (primary timepoint), 26 weeks post vaccine booster dose.]→SARS-CoV-2 spike protein-specific T cell response will be assessed by IFN-gamma ELISpot. [Prior to initial vaccine dose, 20 days post initial vaccine dose, 20 days post vaccine booster dose (primary timepoint), 26 weeks post vaccine booster dose.];Detectable seroconversion of IgG against SARS-CoV-2 spike protein and receptor-binding domain will be assessed by enzyme-linked immunosorbent assay. [Prior to initial vaccine dose, 20 days post initial vaccine dose, 20 days post vaccine booster dose (primary timepoint), 26 weeks post vaccine booster dose.];Capacity of serum to neutralise SARS-CoV-2 spike protein-expressing pseudovirus will be assessed by a pseudovirus neutralisation assay.[Prior to initial vaccine dose, 20 days post initial vaccine dose, 20 days post vaccine booster dose (primary timepoint), 26 weeks post vaccine booster dose.] | | | | No | False | | |
| ISRCTN14624773 | 7 June 2021 | Diabetes, high blood pressure and COVID-19 exposure screening in a dental setting | Diabetes, hypertension and COVID-19 exposure screening in a tertiary care dental setting (DIHSCO) | | University College London | 25/05/2021 | 20210525 | ISRCTN | http://isrctn.com/ISRCTN14624773 | Recruiting | No | | | Both | 24/05/2021 | 1056 | Observational | Observational; Design type: Cross-sectional (Screening) | Not Applicable | United Kingdom | | | | | | | Inclusion criteria: <br> 1. At least 18 years of age and in good general health<br> 2. A minimum of 20 teeth (not including dental implants)<br> 3. Must voluntarily agree to sign the consent form<br> | Exclusion criteria: <br> 1. Uncontrolled or currently undergoing treatment for systemic medical conditions (excluding diabetes and hypertension) including, but not limited to hepatic disease, renal disease, transmittable diseases, cancer, or HIV<br> 2. On chronic treatment (defined as 2 weeks or more) of antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline assessment<br> 3. Self-reported pregnancy or lactation (due to possible oral tissue changes related to pregnancy and breastfeeding which can affect the interpretation of study results)<br> 4. Concurrently participating in other clinical studies<br> | Diabetes, hypertension, COVID-19 (SARS-CoV-2 infection) <br>Not Applicable <br>Diabetes mellitus, hypertensive diseases | <br> This is a single-centre, observational prospective study with two groups for secondary outcome analysis: participants with an intact periodontium and those with periodontitis.<br><br> Clinical assessments and sample collections will be performed at the same time points for all participants. The study participants will be recruited from those individuals attending the Eastman Dental Hospital and/or Institute presenting with periodontitis to the postgraduate Periodontology clinic and those with a healthy periodontium on other postgraduate clinics.<br><br> Following the baseline visit with clinical assessment, qualifying participants will be consented and scheduled for a second visit for sample collection (If time permits, visit 1 and visit 2 can be performed on the same date). Participants identified as having a high HbA1c level (>42 mmol/mol), high blood pressure (>130/85 mmHg) and/or COVID-19 positive antibody or antigen test will be given a written letter addressed to their general medical practitioner (GP) stating the findings. This letter will request for their GP to follow up the patient, carry out further investigation and manage as they see necessary for definitive diagnosis. No further follow-up will be required.<br><br> The study will recruit 1056 participants, based upon a sample size calculation.<br><br> Prior to Visit 1:<br> All patients scheduled to attend the Restorative new patient clinic will be mailed a participant information sheet and presented with the details of the study prior to attending the new patient clinic. This information will be mailed attached to their clinical appointment letter and medical history questionnaire. The mailing will be organised by the Eastman Central Registry | <br> 1. Prevalence of elevated HbA1c in the study population, measured using a point of care test (POCT) Quo-Test Analyser at baseline<br> 2. Prevalence of elevated blood pressure in the study population, measured using an automated blood pressure machine at baseline<br> 3. Prevalence of positive tests results for COVID-19 antigen and antibody tests in the study sample, measured with a BioCredit COVID-19 AG antigen test and a COVID-19 antibody test at baseline<br> | | 24/05/2024 | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2021-001769-19-SE | 7 June 2021 | Immune response to SARS-CoV-2 in health care workers, previously infected subjects, and immunocompromised subjects, before and after Covid-19 vaccination: a phase IV trial | Immune response to SARS-CoV-2 in health care workers, previously infected subjects, and immunocompromised subjects, before and after Covid-19 vaccination: a phase IV trial | | GUVAX (Gothenburg University Vaccine Research Institute) | 29/03/2021 | 20210329 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-001769-19 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 15/04/2021 | 1200 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Sweden | Clinical Trials Information | | Box 435 | anna.lundgren@microbio.gu.se | | GUVAX | Inclusion criteria: <br>Provided written informed consent<br>Vaccinated against SARS-CoV-2<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 900<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 300<br> | Exclusion criteria: <br>None<br> | SARS-COV-2 infection <br>MedDRA version: 23.0
Level: LLT
Classification code 10084272
Term: SARS-CoV-2 infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Comirnaty<br>Pharmaceutical Form: Injection<br><br>Trade Name: COVID-19 Vaccine Moderna<br>Pharmaceutical Form: Injection<br><br>Trade Name: COVID-19 Vaccine AstraZeneca<br>Pharmaceutical Form: Injection<br><br>Trade Name: COVID-19 Vaccine Janssen<br>Pharmaceutical Form: Injection<br><br> | Timepoint(s) of evaluation of this end point: 1 month, 6 months, 12 months and 24 months post primary vaccination;Primary end point(s): SARS-CoV-2-specific serum antibodies;Secondary Objective: Not applicable;Main Objective: Does the humoral immune response after vaccination against Covid-19 differ between immune competent subjects and patients with primary or secondary immune deficiency? | | | | Yes | False | | |
| → | EUCTR2020-005979-12-BG | 7 June 2021 | Efficacy and safety of XAV-19 for the treatment of moderate to severe COVID-19 | An international, placebo-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of 150 mg XAV-19 infusion, in patients with moderate to severe COVID-19: the EUROXAV study - EUROXAV Study | | XENOTHERA | 12/04/2021 | 20210412 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005979-12 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 17/05/2021 | 722 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Bulgaria;Turkey;Romania;Spain;Greece | Chief Operating Officer | | 1 rue Vauban | bernard.vanhove@xenothera.com | 33255101173 | XENOTHERA | Inclusion criteria: <br>I1) Male or female patient aged 18 years or over, weighing >50 Kg and <120 Kg, at the time of signing the informed consent,<br>I2) Patient presenting in a specialized or an emergency unit <br>I3) Patient presenting signs of pneumonia evidenced by at least 1 of the following: auscultation, chest X-Ray, CT scan OR presenting COVID-19 related symptoms having started less than 10 days prior to screening visit, including at least 2 of the following: fever, cough, sore throat or nasal discharge, dyspnea (shortness of breath), thoracic pain, headache or fatigue, myalgia, anosmia, dysgeusia, diarrhea, nausea <br>I4) Patient with SpO2 > 90% (at ambient air) <br>I5) Patient with a first positive SARS-CoV-2 test (RT-PCR, RT-qPCR or antigen test) in the last 10 days or at screening<br>I6) Women of childbearing potential (WOCBP) must have a negative urine pregnancy test at screening and use a highly effective1 birth control until 90 days after the administration of study drug<br>I7) Non-vasectomized male patients having a female partner of childbearing potential must agree to use a highly effective method of contraception until 90 days after the administration of study drug,<br>I8) Patient capable of giving signed informed consent.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 288<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 434<br> | Exclusion criteria: <br>E1) Patient with a positive SARS CoV-2 test (RT-PCR, RT-qPCR or antigen test) of more than 10 days before the screening visit<br>E2) Patient with multiorgan failure<br>E3) Patient requiring immediate Intensive Care Unit (ICU) hospitalization<br>E4) Patient participating in another clinical trial with an investigative agent<br>E5) Pregnancy or breastfeeding<br><br><br> | Moderate to severe COVID-19 <br>MedDRA version: 23.1
Level: PT
Classification code 10084460
Term: COVID-19 treatment
System Organ Class: 10042613 - Surgical and medical procedures
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: XAV-19 <br>Product Code: XAV-19 <br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Anti-viral immunoglobulins<br>Current Sponsor code: XAV-19<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 5-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intravenous use<br><br> | Main Objective: The primary objective is to compare the clinical efficacy of XAV-19 to that of placebo in patients with COVID-19.;Secondary Objective: The secondary objectives are:<br>- to compare the change in clinical parameters (fever, respiratory rate, shortness of breath, thoracic pain, SpO2, supplemental O2) in patients treated with XAV-19 to that in patients treated with Placebo,<br>- to compare the length of hospital stay of patients treated with XAV-19 to that of patients treated with Placebo,<br>- to compare the viral status of patients treated with XAV-19 to that of patients treated with Placebo, <br>- to compare the safety profile in patients with COVID-19 treated with XAV-19 to that in patients treated with Placebo<br>;Timepoint(s) of evaluation of this end point: Within 8 days after treatment.;Primary end point(s): The primary endpoint is the proportion of patients with an aggravation of COVID-19 within 8 days after treatment. The aggravation is defined as a worsening of the score of at least 1 point on the WHO 7-point ordinal scale compared to the score on the WHO-7 ordinal scale at randomization.→Timepoint(s) of evaluation of this end point: Within 8 days after treatment.;Secondary Objective: The secondary objectives are:<br>- to compare the change in clinical parameters (fever, respiratory rate, shortness of breath, thoracic pain, SpO2, supplemental O2) in patients treated with XAV-19 to that in patients treated with Placebo,<br>- to compare the length of hospital stay of patients treated with XAV-19 to that of patients treated with Placebo,<br>- to compare the viral status of patients treated with XAV-19 to that of patients treated with Placebo, <br>- to compare the safety profile in patients with COVID-19 treated with XAV-19 to that in patients treated with Placebo<br>;Main Objective: The primary objective is to compare the clinical efficacy of XAV-19 to that of placebo in patients with COVID-19.;Primary end point(s): The primary endpoint is the proportion of patients with an aggravation of COVID-19 within 8 days after treatment. The aggravation is defined as a worsening of the score of at least 1 point on the WHO 7-point ordinal scale compared to the score on the WHO-7 ordinal scale at randomization. | | | | Yes | False | | |
| EUCTR2020-005366-34-ES | 7 June 2021 | A Study to Evaluate the Antiviral Activity, Safety, Pharmacokinetics, and Efficacy of RO7496998 (AT-527) in Non-Hospitalized Adult Patients with Mild or Moderate COVID-19 | A PHASE II RANDOMIZED, DOUBLE-BLIND,
PLACEBO-CONTROLLED STUDY TO EVALUATE
THE ANTIVIRAL ACTIVITY, SAFETY,
PHARMACOKINETICS, AND EFFICACY OF
RO7496998 (AT-527) IN
NON-HOSPITALIZED ADULT PATIENTS WITH
MILD OR MODERATE COVID-19 - Phase II virology covid study | | F. Hoffmann La Roche Ltd. | 20/04/2021 | 20210420 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005366-34 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 02/06/2021 | 220 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United Kingdom;Bulgaria;Ireland;Spain;Poland;Greece | Trial Information Support Line-TISL | | Grenzacherstrasse 124 | spain.start_up_unit@roche.com | | F.Hoffmann-La Roche, Ltd. | Inclusion criteria: <br>Age>=18 years at time of signing Informed Consent Form<br>• Positive SARS-CoV-2 diagnostic test (RT-PCR or rapid antigen test) at screening<br>• Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset <=5 days prior to randomization<br>• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception, during the treatment period and for 30 days after the final dose of AT-527.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 198<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 22<br> | Exclusion criteria: <br>Clinical signs indicative of COVID-19 illness requiring hospitalization, defined as any of the following: shortness of breath at rest, respiratory rate >= 30, heart rate >= 125, peripheral capillary oxygen saturation (SpO2) <= 93% on room air<br>• Treatment with a therapeutic agent against SARS-CoV-2 including, but not limited to, other direct-acting antivirals, convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 drug-elimination half-lives (whichever is longer) prior to screening<br>• Requirement, in the opinion of the investigator, for any of the prohibited medications during the study<br>• Use of hydroxychloroquine or amiodarone within 7 days of screening<br>• Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of AT-527. Women of childbearing potential must have a negative serum pregnancy test result at screening<br>Abnormal laboratory test results at screening<br>• Clinically significant abnormal ECG, as determined by the Investigator, at screening<br>• Planned procedure or surgery during the study<br>• Known allergy or hypersensitivity to study drug or drug product excipients<br>• Substance abuse, as determined by the investigator, within 12 months prior to screening<br>• Poor peripheral venous access<br>• Malabsorption syndrome or other condition that would interfere with enteral absorption<br>Any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalized due to epistaxis of any previous occasion <br>• History of anaphylaxis<br>• Any uncontrolled serious medical condition or other clinically significant abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study<br> | Coronavirus disease 2019 (COVID-19) <br>MedDRA version: 23.1
Level: LLT
Classification code 10084401
Term: COVID-19 respiratory infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: AT-527<br>Product Code: RO7496998<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Not available yet<br>CAS Number: 2241337-84-6<br>Current Sponsor code: RO7496998 (AT-527)<br>Other descriptive name: AT-511 HEMI-SULFATE SALT<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 550-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br>Product Name: AT-527<br>Product Code: RO7496998/F10-02<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Not available yet<br>CAS Number: 2241337-84-6<br>Current Sponsor code: RO7496998(AT-527)<br>Other descriptive name: AT-511 HEMI-SULFATE SALT<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 275-<br><br> | Timepoint(s) of evaluation of this end point: 1. Baseline (Day 1) to Day 7;Primary end point(s): Change from baseline in amount of SARS-CoV-2 virus RNA as measured by RT-PCR at specified timepoints;Secondary Objective: • To evaluate the antiviral activity of AT 527 compared with placebo based on time to cessation of SARS-CoV-2 viral shedding, time to sustained non-detectable SARS-CoV-2 virus RNA, proportion of patients positive for SARS-CoV-2 virus RNA, and area under the curve in the amount of SARS-CoV-2 virus RNA<br>• To evaluate the safety of AT 527 compared with placebo<br>• To characterize the PK profile of AT-511 (free base form of AT 527) and its major metabolites<br>• To evaluate the relationship between drug exposure and antiviral activity of AT-527<br>• To evaluate the efficacy of AT 527 compared with placebo;Main Objective: • To evaluate the antiviral activity of AT-527 compared with placebo based on change from baseline in amount of SARS-CoV-2 virus RNA | | | | Yes | True | parent | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04854798 | 14 June 2021 | UNITE Study (UMN-SW) for COVID-19 | Ultrasound Neural and Immunomodulation Treatment Evaluation Study (UMN-SW) for COVID-19 With Wearable Ultrasound Device | | University of Minnesota | 20/04/2021 | 20210420 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04854798 | Recruiting | No | 18 Years | N/A | All | April 29, 2021 | 58 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United States | ; | Erik Peterson, M.D.;Andrew Olson, M.D. | | ; | ; | University of Minnesota;University of Minnesota |
<br> Inclusion Criteria:
<br>
<br> - Age 18 and above
<br>
<br> - Positive for SARS-CoV-2 (via PCR)
<br>
<br> - Decreased blood oxygen saturation: Room air SaO2 < 94% and/or requiring supplemental
<br> oxygen at a flow rate of 2 L/min or greater
<br>
<br> - Admission to the hospital
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnant women
<br>
<br> - Asplenia
<br>
<br> - Ascites
<br>
<br> - Open wound/sores near the stimulation site
<br>
<br> - Recent abdominal surgery
<br>
<br> - Splenomegaly
<br>
<br> - Mechanically ventilated (if patient goes onto mechanical ventilation while
<br> participating in the study, they can continue ultrasound treatment if recommended by
<br> SOC clinician and investigators of this study)
<br>
<br> - Comfort care status
<br>
<br> - Any other clinical reasons deemed by the investigators of the study in which the
<br> patient would not be an appropriate candidate for the study
<br> | | Covid19;Cytokine Storm;Inflammation | Device: Splenic Ultrasound | IL-1ß levels;IL-6 levels | | | | Yes | False | | |
| → | NCT04860869 | 14 June 2021 | Endocrine, Metabolic and Microbiome Influence on the Post COVID-19 Syndrome | Endocrine, Metabolic and Microbiome Influence on the Post-COVID Syndrome | | The University of Texas Medical Branch, Galveston | 03/03/2021 | 20210303 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04860869 | Recruiting | No | 30 Years | 60 Years | All | May 12, 2021 | 32 | Observational | | | United States | ; ; | Randall Urban, MD;Kate Randolph, BS;Christopher Danesi, MS | | ;kmrandol@utmb.edu;cpdanesi@utmb.edu | ;409-223-7891;409-772-8126 | University of Texas; |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female with a history of COVID with diagnosis confirmed by PCR test.
<br>
<br> 2. Has been seen at UTMB Post COVID clinic.
<br>
<br> 3. Minimum of 6 months since diagnosis of COVID by PCR test.
<br>
<br> 4. Ages 30 to 60 years.
<br>
<br> 5. Score of 3 or higher on any question 1-3 of the Brief Fatigue Inventory (BFI)
<br> questionnaire.
<br>
<br> 6. Participant is willing and able to give informed consent for participation in the
<br> study.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Current COVID infection.
<br>
<br> 2. Unable to walk unassisted.
<br>
<br> 3. Significant heart, liver, kidney, blood or respiratory disease.
<br>
<br> 4. Uncontrolled diabetes mellitus.
<br>
<br> 5. Any history of a recently (12 months) diagnosed cancer other than a skin cancer
<br> (excluding melanoma).
<br>
<br> 6. Current alcohol or drug abuse.
<br>
<br> 7. History of psychosis.
<br>
<br> 8. Pregnancy or become pregnant during the trial.
<br>
<br> 9. Subjects who are being managed with narcotics will be excluded as the effects of
<br> central nervous system depressants may interfere with study test results.
<br>
<br> 10. Other medical condition or medication administration deemed exclusionary by the study
<br> investigators.
<br> | | Covid19 | | Cortisol as measured by the adrenocorticotropic hormone stimulation test (ACTH) 30 minutes after cortrosyn administration;Cortisol as measured by the adrenocorticotropic hormone stimulation test (ACTH) 60 minutes after cortrosyn administration;Cognitive Function as measured by Montreal Cognitive Assessment;Walking as measured by 6 minute walk test;Fatigue as measured by the Multidimensional Fatigue Symptom Inventory;Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults;Depression measured by the Beck Depression Inventory-II;Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale;Cortisol as measured by the adrenocorticotropic hormone stimulation test (ACTH) before cortrosyn administration;Basal Metabolic rate as measured by Resting Energy Expenditure;Growth hormone as measured by Glucagon Stimulation Test 180 minutes after glucagon administration;Growth hormone as measured by Glucagon Stimulation Test 150 minutes after glucagon administration;Growth hormone as measured by Glucagon Stimulation Test 120 minutes after glucagon administration;Growth hormone as measured by Glucagon Stimulation Test 90 minutes after glucagon administration;Growth hormone as measured by Glucagon Stimulation Test before glucagon administration;Strength as measured by using hand grip dynamometry;Sleep Quality as measured by Pittsburgh Sleep Quality Index;Independence measured by Instrumental Activities of Daily Living;Functional Status as measured by Activities of Daily Living;Distress is measured by the Impact of Event Scale;Depression as measured by the Hospital Anxiety and Depression Scale;Anxiety as measured by the Hospital Anxiety and Depression Scale;Qualify of life as measured by Medical Outcome Study - Short Form 36;Depression/Anxiety as measured by the EuroQOL-5 Dimensions;Discomfort as measured by the EuroQOL-5 Dimensions;Usual Activity as measured by the EuroQOL-5 Dimensions;Self-care as measured by the EuroQOL-5 Dimensions;Mobility as measured by the EuroQOL-5 Dimensions;Characterization of nasal microbiome using molecular methods;Characterization of oral microbiome using molecular methods;Characterization of fecal microbiome using molecular methods;Insulin-Like Growth Factor-1 (IGF1);Follicle Stimulating Hormone (FSH);Sex Hormone Binding Globulin (SHBG);Total Testosterone;Free Testosterone;Prolactin;Thyroid Stimulating Hormone (TSH);C Reactive Protein (CRP);Vitamin B12;Vitamin D;Glucose tolerance as measured by the Oral Glucose Tolerance Test (OGTT) before glucose consumption;Glucose tolerance as measured by the Oral Glucose Tolerance Test (OGTT) 120 minutes after glucose consumption;Insulin as measured by the Oral Glucose Tolerance Test (OGTT) before glucose consumption;Insulin as measured by the Oral Glucose Tolerance Test (OGTT) 120 minutes after glucose consumption;Glucose derived CO2 as measured by breath during the Oral Glucose Tolerance Test (OGTT) before glucose consumption;Glucose derived CO2 as measured by breath during the Oral Glucose Tolerance Test (OGTT) 120 minutes after glucose consumption→Cortisol as measured by the adrenocorticotropic hormone stimulation test (ACTH) 30 minutes after cortrosyn administration;Cortisol as measured by the adrenocorticotropic hormone stimulation test (ACTH) 60 minutes after cortrosyn administration;Cognitive Function as measured by Montreal Cognitive Assessment;Walking as measured by 6 minute walk test;Fatigue as measured by the Multidimensional Fatigue Symptom Inventory;Symptoms of Growth Hormone Deficiency measured by the questionnaire Quality of Life - Assessment of Growth Hormone Deficiency in Adults;Depression measured by the Beck Depression Inventory-II;Gastrointestinal Health measured by the Gastrointestinal Symptom Rating Scale;Cortisol as measured by the adrenocorticotropic hormone stimulation test (ACTH) before cortrosyn administration;Basal Metabolic rate as measured by Resting Energy Expenditure;Growth hormone as measured by Glucagon Stimulation Test 180 minutes after glucagon administration;Growth hormone as measured by Glucagon Stimulation Test 150 minutes after glucagon administration;Growth hormone as measured by Glucagon Stimulation Test 120 minutes after glucagon administration;Growth hormone as measured by Glucagon Stimulation Test 90 minutes after glucagon administration;Growth hormone as measured by Glucagon Stimulation Test before glucagon administration;Strength as measured by using hand grip dynamometry;Sleep Quality as measured by Pittsburgh Sleep Quality Index;Independence measured by Instrumental Activities of Daily Living;Functional Status as measured by Activities of Daily Living;Distress is measured by the Impact of Event Scale;Depression as measured by the Hospital Anxiety and Depression Scale;Anxiety as measured by the Hospital Anxiety and Depression Scale;Qualify of life as measured by Medical Outcome Study - Short Form 36;Depression/Anxiety as measured by the EuroQOL-5 Dimensions;Discomfort as measured by the EuroQOL-5 Dimensions;Usual Activity as measured by the EuroQOL-5 Dimensions;Self-care as measured by the EuroQOL-5 Dimensions;Mobility as measured by the EuroQOL-5 Dimensions;Glucose derived CO2 as measured by breath during the Oral Glucose Tolerance Test (OGTT) 120 minutes after glucose consumption;Characterization of nasal microbiome using molecular methods;Characterization of oral microbiome using molecular methods;Characterization of fecal microbiome using molecular methods;Insulin-Like Growth Factor-1 (IGF1);Follicle Stimulating Hormone (FSH);Sex Hormone Binding Globulin (SHBG);Total Testosterone;Free Testosterone;Prolactin;Thyroid Stimulating Hormone (TSH);C Reactive Protein (CRP);Vitamin B12;Vitamin D;Glucose tolerance as measured by the Oral Glucose Tolerance Test (OGTT) before glucose consumption;Glucose tolerance as measured by the Oral Glucose Tolerance Test (OGTT) 120 minutes after glucose consumption;Insulin as measured by the Oral Glucose Tolerance Test (OGTT) before glucose consumption;Insulin as measured by the Oral Glucose Tolerance Test (OGTT) 120 minutes after glucose consumption;Glucose derived CO2 as measured by breath during the Oral Glucose Tolerance Test (OGTT) before glucose consumption | | | | Yes | False | | |
| NCT04867265 | 14 June 2021 | Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic | Mouth-to-mouth Ventilation Efficiency Through Breathable Self-sterilizing Respirator During BLS in COVID-19 Pandemic: a Crossover Simulation-based Study | MOVERESP | Brno University Hospital | 26/04/2021 | 20210426 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04867265 | Not recruiting | No | 18 Years | 100 Years | All | May 3, 2021 | 104 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: None (Open Label). | N/A | Czechia | ; | Martina Kosinova, assoc. prof. MD., Ph.D.;Petr Štourac, prof.MD.Ph.D. | | ; | ; | Faculty of medicince Masaryk University and University Hospital Brno;Faculty of medicince Masaryk University and University Hospital Brno |
<br> Inclusion Criteria:
<br>
<br> - medical students trained in BLS as BLS trainers
<br>
<br> - medical students trained in BLS
<br>
<br> Exclusion Criteria:
<br>
<br> - refusing to participate
<br>
<br> - non-medical students
<br> | | Ventilation During Resuscitation | Procedure: Mout-to-mouth ventilation;Procedure: Mout-to-mouth ventilation with quantitative analysis | Mouth-to-mouth ventilation effectivity | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2021-000291-11-AT | 14 June 2021 | Immuneresponse and clinical efficacy after SARS-CoV-2 Vaccination in immunodefficient patients or those undergoing immunosuppresive therapy (COVID-19) | Characterization of immune responsiveness after SARS-CoV-2 Vaccination in patients with Immunodeficiency or immunosuppressive therapy (COVID-19) - Immune response after SARS-CoV-2 vaccination (COVID-19) | | Medical University of Vienna | 11/05/2021 | 20210511 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000291-11 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 30/05/2021 | 3000 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Vaccination response of immunocompromised Patients will be compared to non immunocompromised control<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Austria | Selma Tobudic | | Waehringer Guertel 18-20 | selma.tobudic@meduniwien.ac.at | 004314040044400 | Medical University of Vienna | Inclusion criteria: <br>Male and female subjects will be eligible for participation in this study if they:<br>• Are =18 years on the day of screening<br>• Have a disease that is associated with a well characterized immunodeficiency (study population)<br>• Treated with an immunosuppressive therapy (study population)<br>• Have an immune-mediated disease without an immunosuppressive therapy, e.g. IBD patients solely with 5-ASA treatment (study population)<br>• Are clinically healthy and not vaccinated with a SARS-CoV-2 vaccine (control group, age and sex-matched)<br>• Have an understanding of the study, agree to its provisions, and give written informed consent prior to study entry<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 2000<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 1000<br> | Exclusion criteria: <br>Are not willing to get SARS-CoV-2 Vaccination<br> | Vaccination against SARS-CoV-2 in immunocompromised patients <br>MedDRA version: 23.0
Level: LLT
Classification code 10084462
Term: SARS-CoV-2 vaccination
System Organ Class: 100000004865
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Cominranty concentrate for dispersion for injection<br>Product Name: Corminaty<br>Product Code: BNT162B2<br>Pharmaceutical Form: Injection<br>INN or Proposed INN: Tozinameran<br>Other descriptive name: Self-amplifying RNA encoding SARS-CoV-2 stabilised spike protein<br>Concentration unit: µg microgram(s)<br>Concentration type: not less then<br>Concentration number: 30-<br><br>Trade Name: COVID-19 Vaccine Moderna dispersion for injection<br>Product Name: COVID-19 Vaccine Moderna dispersion for injection<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: mRNA-1273<br>Other descriptive name: Self-amplifying RNA encoding SARS-CoV-2 stabilised spike protein<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br> | Timepoint(s) of evaluation of this end point: 28 days after second dose;Primary end point(s): To assess the humoral immunogenicity of the SARS-Cov-2 vaccination, the outcome of ELISA test and neutralization test will be analyzed one month after the second vaccination. Therefore, the number of subjects with positive seroconversion rate against SARS-CoV-2 will be evaluated.;Secondary Objective: Besides various biomedical analyzes, cellular immunogenicity of the SARS-Cov-2 vaccination in immunosuppressed patients, T cell proliferation will be assessed and T-cell cytokine expression will be measured using flow-cytometry after in vitro stimulation with peripheral blood mononuclear cells with SARS-Cov-2 antigen. Difference in humoral immunogenicity depending upon previous exposure to SARS-CoV-2 will be analyzed.;Main Objective: The aim of the study is to estimate the humoral and cellular immune responses after mRNA vaccine against SARS-Cov-2 in adult patients with immunodeficiencies or treated with immunosuppressive/modulating therapy. <br>Primary objective:<br>To assess the humoral immunogenicity to a SARS-CoV-2 vaccine in immunosuppressed patients compared to healthy volunteers, the quantitative antibody levels will be measured by enzyme-linked immunosorbent assay test (ELISA) and in addition using neutralization test (NT)<br>The null hypothesis has to be rejected that there is no difference in the seroconversion rate between the immunosuppressed patients and the healthy volunteers after SARS-CoV-2 vaccination<br> | | | | Yes | False | | |
| → | EUCTR2020-006082-11-GR | 14 June 2021 | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants with Mild or Moderate COVID-19 (STAMP) | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants with Mild or Moderate COVID-19 (STAMP) | | Adagio Therapeutics Inc. | 21/05/2021 | 20210521 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-006082-11 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 02/06/2021 | 1084 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Greece;Ukraine;Germany;Bulgaria;South Africa;Peru;Poland;Brazil;Argentina;Mexico;Hungary;Chile;Turkey→Germany;Bulgaria;South Africa;Peru;Poland;Brazil;Argentina;Mexico;Hungary;Ukraine;Greece;Chile;Turkey | Clinical Trial Information Desk | | 303 Wyman Street, Suite 300 | clinicaltrials@adagiotx.com | +1781819 0080 | Adagio Therapeutics Inc. | Inclusion criteria: <br>1. Age:<br>a. Ph 2: Is an adult aged 18 years and above<br>b. Ph 3: Is an adult aged 18 years and above or is an adolescent aged 12-17 years (inclusive) and weighing =40 kg at the time of screening <br>2. Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular diagnostic assay obtained within 5 days prior to randomization<br>3. Has had initial onset of one or more of the following self-reported COVID-19-related signs or symptoms within 5 days prior to randomization: <br>(temperature =38°C, subjective fever, chills, cough, sore throat, congestion, shortness of breath or difficulty breathing with exertion worse than usual, muscle or body aches, fatigue, headache, loss of taste or smell, nausea or vomiting, diarrhea)<br>4. Has one or more of the following COVID-19-related signs or symptoms on the day of randomization<br>(temperature =38°C, subjective fever, chills, cough, sore throat, congestion, shortness of breath or difficulty breathing with exertion worse than usual, muscle or body aches, fatigue, headache, loss of taste or smell, nausea or vomiting, diarrhea)<br>5. Is at high risk of disease progression defined as:<br>a. Age >55 years<br>b. Age 18 to =55 years with one or more stable preexisting medical conditions as follows <br>i. Obesity [BMI = 30 kg/m2]<br>ii. Diabetes (Type 1 or Type 2)<br>iii. Chronic kidney disease<br>iv. Chronic lung disease <br>v. Cardiac disease<br>vi. Sickle cell disease or thalassemia <br>vii. Solid organ or blood stem cell transplant recipients<br>viii. Other immunodeficiency due to underlying illness or immunosuppressant medication<br>ix. Down Syndrome<br>x. Stroke or cerebrovascular disease, which affects blood flow to the brain<br>xi. Substance use disorder<br>xii. Pregnant (Phase 3 only; after review Ph2 data by iDMC)<br>c. Age 12 to 17 years (inclusive) with one or more preexisting medical conditions as follows<br>i. BMI >85th percentile for age and gender based on CDC growth charts<br>ii. Diabetes (Type 1 or 2)<br>iii. Chronic kidney disease<br>iv. Sickle cell disease or thalassemia<br>v. Congenital or acquired heart disease<br>vi. Neurodevelopmental disorders<br>vii. A medically related technological dependence<br>viii. Asthma, reactive airway or other chronic respiratory disease that requires daily medication for control<br>ix. Solid organ or blood stem cell transplant recipients<br>x. Other immunodeficiency due to underlying illness or immunosuppressant medication<br>xi. Substance use disorder<br>xii Pregnant (Ph 3 only: enrollment only after Ph2 data reviewed by iDMC)<br>6. Has been assigned female sex at birth and is of nonchildbearing potential. A female participant who is not of reproductive potential is eligible without requiring the use of contraception and pregnancy testing is not required. This includes female participants who have not undergone menarche or who are documented to be surgically sterile or postmenopausal. Follicle stimulating hormone is not required in postmenopausal females with amenorrhea for >2 years.<br>7. Has been assigned female sex at birth and is of childbearing potential and fulfills all the following criteria: <br>a. Has a negative urine or serum pregnancy test at Screening<br>b. Has practiced adequate contraception for or has abstained from all activities that could result in pregnancy for at least 28 days prior to the first dose (Day 1)<br>c. Has agreed to continue adequate contraception for sexual activity that could lead to pregnancy through 6 months following study drug administration<br>d. Is not currently breastfeeding<br>Adequate contraception for particip | Exclusion criteria: <br>1. Is currently hospitalized or in the opinion of the investigator requires urgent medical attention or is anticipated to require hospitalization within 48 hours of randomization<br>2. Has oxygen saturation (SpO2) =93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of mercury) to fractional inspired oxygen (FiO2) <300 mmHg, respiratory rate =30 per minute, or heart rate =125 per minute.<br>3. Is on supplemental oxygen therapy at the time of randomization for any reason or in the opinion of the investigator anticipated impending need for mechanical ventilation.<br>4. Has a history of a positive SARS CoV 2 antibody serology test. Note: serology testing is not required for study eligibility, exclusion criterion is based on known history only. <br>5. Has participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed.<br>6. Has known allergy/sensitivity or hypersensitivity to study drug, including excipients.<br>7. Has received a SARS CoV 2 vaccine, monoclonal antibody, or plasma from a person who recovered from COVID 19 any time prior to participation in the study. <br>8. Has a known active co infection (eg, influenza, urinary tract infection, etc).<br>9. Has any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the participant by their participation in the study including but not limited to any co-morbidity requiring surgery or conditions considered life-threatening within 29 days.<br>10. Has a clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venipuncture.<br>11. Is or has an immediate family member (eg, spouse, sibling, child, guardian/LAR, parent) who is an investigator or site or sponsor staff (or designee) directly involved with the study.<br><br> | COVID-19 <br>MedDRA version: 23.0
Level: LLT
Classification code 10084382
Term: Coronavirus disease 2019
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Code: ADG20<br>Pharmaceutical Form: Solution for injection<br>CAS Number: 2516243-50-0<br>Current Sponsor code: ADG20<br>Other descriptive name: ADG20<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 100-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intramuscular use<br><br> | Timepoint(s) of evaluation of this end point: - day 29<br>- day 4 and day 29;Primary end point(s): - COVID-19 related hospitalization or all-cause death through Day 29<br>- Assessment of safety through Day 29 based on:<br>o The incidence of TEAEs<br>o Incidence of solicited injection site reactions through Day 4<br>o Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation) <br>o Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure)<br>;Secondary Objective: - To evaluate the effect of ADG20 on the following clinical parameters in participants with mild or moderate COVID 19 and high risk of disease progression<br>o Severity of COVID-19<br>o COVID-19 related emergency room visits, COVID-19 related hospitalizations, or all cause death<br>o COVID-19 related medically attended visits<br>o Time to sustained recovery of COVID-19 symptoms<br>o All cause mortality<br>- To evaluate the effect of ADG20 on SARS-CoV-2 viral load and clearance in participants with mild or moderate COVID-19 and high risk of disease progression<br>- To evaluate the safety and tolerability of ADG20 compared to placebo through Month 14 in participants with mild or moderate COVID-19 and high risk of disease progression<br>- To evaluate the PK of ADG20 following IM administration <br>- To evaluate the immunogenicity (ADAs) to ADG20<br>- To evaluate the emergence of resistance to ADG20<br>;Main Objective: - To evaluate the efficacy of ADG20 compared to placebo in the treatment of mild or moderate COVID 19 in participants at high risk of disease progression<br>- To evaluate the safety and tolerability of ADG20 compared to placebo through Day 29 in participants with mild and moderate COVID-19 and high risk of disease progression→Timepoint(s) of evaluation of this end point: - day 29<br>- day 4 and day 29;Secondary Objective: - To evaluate the effect of ADG20 on the following clinical parameters in participants with mild or moderate COVID 19 and high risk of disease progression<br>o Severity of COVID-19<br>o COVID-19 related emergency room visits, COVID-19 related hospitalizations, or all cause death<br>o COVID-19 related medically attended visits<br>o Time to sustained recovery of COVID-19 symptoms<br>o All cause mortality<br>- To evaluate the effect of ADG20 on SARS-CoV-2 viral load and clearance in participants with mild or moderate COVID-19 and high risk of disease progression<br>- To evaluate the safety and tolerability of ADG20 compared to placebo through Month 14 in participants with mild or moderate COVID-19 and high risk of disease progression<br>- To evaluate the PK of ADG20 following IM administration <br>- To evaluate the immunogenicity (ADAs) to ADG20<br>- To evaluate the emergence of resistance to ADG20<br>;Main Objective: - To evaluate the efficacy of ADG20 compared to placebo in the treatment of mild or moderate COVID 19 in participants at high risk of disease progression<br>- To evaluate the safety and tolerability of ADG20 compared to placebo through Day 29 in participants with mild and moderate COVID-19 and high risk of disease progression;Primary end point(s): - COVID-19 related hospitalization or all-cause death through Day 29<br>- Assessment of safety through Day 29 based on:<br>o The incidence of TEAEs<br>o Incidence of solicited injection site reactions through Day 4<br>o Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation) <br>o Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure)<br> | | | | Yes | False | | |
| EUCTR2021-001735-10-BE | 14 June 2021 | COVID-19: A study to learn about the safety, local and systemic reactions, and the immune responses to the SARS-CoV-2 mRNA Vaccine (CVnCoV) when given to participants 45 years or older who have either a solid tumor or blood cancer and are already taking or about to start systemic anticancer therapy
| COVID-19: A Phase 3, open-label, parallel group, multicenter clinical study to evaluate the safety, reactogenicity, and immunogenicity of the investigational SARS-CoV-2 mRNA vaccine CVnCoV in participants 45 years or older with either a solid tumor or hematologic malignant disease who are receiving or scheduled to receive systemic anticancer therapy (independent of intent) | | Bayer AG | 04/06/2021 | 20210604 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-001735-10 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 28/05/2021 | 620 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: <br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Spain;Belgium;Austria;Germany | Bayer Clinical Trial Contacts | | Not applicable | clinical-trials-contact@bayer.com | 4930300139003 | Bayer AG | Inclusion criteria: <br>1.Participant of 45 years of age or older, at the time of signing the informed consent.
<br>2.For participants:
<br>For participants with malignancies (Path A, B or C):
<br>a.Path A: Participants with a solid tumor (i.e., NSCLC, CRC, breast cancer, prostate cancer) who have not received prior systemic anticancer therapy and are scheduled for treatment with either chemotherapy alone or chemotherapy in combination with another drug class (independent of intent).
<br>b.Path B: Participants with either a solid tumor (i.e., NSCLC, CRC, breast cancer, prostate cancer, RCC, melanoma) or hematologic malignant disease (lymphoma) who are scheduled to receive systemic anticancer therapy (independent of intent). NOTE: Participants who have received prior lines of systemic anticancer therapy are eligible provided exclusion criterion #5 is not violated.
<br>c.Path C: Participants with NSCLC on ongoing chemotherapy containing regimen.
<br>For healthy participants (Path D):
<br>d.Path D: participants who are generally healthy and have not had any malignant disease that required active treatment in the past 5 years.
<br>Note: healthy participant is defined as an individual who is in good general health. Participants with co-morbidities which are well controlled and clinically stable (on ongoing treatment) can be enrolled.
<br>For all participants:
<br>3.Participants with estimated life expectancy > 13 months as per the judgement of the investigator.
<br>4.Participants with ECOG performance status of 0 or 1 (See Section 10.5).
<br>5.Participants who have adequate bone marrow and organ function as assessed by the following laboratory tests:
<br>a.Hemoglobin = 9 g/dL
<br>b.Absolute neutrophil count (ANC) > 1000/mm3
<br>c.Platelet count > 100000/µl
<br>d.Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x upper limit of normal (ULN) (= 5 x ULN in case of liver metastases)
<br>e.Total bilirubin = 1.5 x ULN
<br>f.Estimated GFR = 30 ml/min/1.73m2 (according to local laboratory standards)
<br>6.Participants expected to be compliant with protocol procedures and available for clinical follow-up to the last planned visit.
<br>Sex and Contraceptive/Barrier Requirements
<br>7.Male or female.
<br>Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
<br>a.Male participants: no contraceptive requirement.
<br>b.Female participants: females of childbearing potential can only be included in the study if a pregnancy test is negative at the screening visit and if they agree to use highly effective methods of contraception from the screening visit until 3 months following the last administration of study vaccine (see Section 10.4 for details).
<br>Informed Consent
<br>8.Capable of giving signed informed consent as described in Section 10.1.3 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 310<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 310<br> | Exclusion criteria: <br>Participants are excluded from the study if any of the following criteria apply:
<br>Prior/Concomitant Therapy
<br>1.Use of any investigational or non-registered product (vaccine or drug other than anticancer therapy) within 28 days or 5 times half-life of the investigational product preceding the administration of the study vaccine, or planned use during the study period.
<br>2.Receipt of any other approved vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or planned receipt of any vaccine within 28 days of study vaccine administration.
<br>3.Receipt of any investigational, authorized or licensed, SARS-CoV-2 or other coronavirus vaccine prior to the administration of the CVnCoV study vaccine or planned receipt during the study.
<br>4.Receipt of any investigational or licensed lipid nanoparticles (LNP)-formulated mRNA vaccine prior to the administration of the study vaccine.
<br>5.Prior systemic anticancer therapy (applicable to Path A and Path B only)
<br>a.Path A: Any prior systemic anticancer therapy
<br>b.Path B: Systemic anticancer therapy within the last 30 days (4 months for immune check point inhibitors and 6 months for anti B cell antibodies)
<br>6.Planned start of investigational anticancer therapy during the vaccination period or within 28 days after the second dose of the study vaccine.
<br>7.Systemic corticosteroid therapy at doses exceeding 0.5 mg/kg/day prednisone equivalent for 14 consecutive days or more within the last 30 days before the scheduled start of study vaccine.
<br>8.Receipt of biologics - most importantly but not limited to recombinant proteins/anti-inflammatory monoclonal antibodies (e.g. anti-TNF, anti-IL6, anti-17 monoclonal antibodies) - within the last 6 months before the scheduled start of study vaccine, with the exception of biologics to treat the underlying cancer or cancer related conditions.
<br>9.Administration of immunoglobulins (Igs) within 3 months preceding the administration of any dose of the study vaccine.
<br>Medical Conditions
<br>10.Prior transplantation of human cells, tissues and major organs (e.g. liver transplant) or candidates for any type of transplantation.
<br>11.Participants not recovered from any surgery related acute toxicities.
<br>12.History of immune-deficiency disorders.
<br>13.History of angioedema (known C1 inhibitor deficiency).
<br>14.History of any anaphylactic reactions.
<br>15.Any known hypersensitivity reaction to any component of CVnCoV or aminoglycoside antibiotics.
<br>16.Acute or currently active and serologically confirmed SARS-CoV-2 infection.
<br>17.History of confirmed SARS, MERS or COVID-19 disease or known exposure to an individual with confirmed COVID-19 disease or SARS-CoV-2 infection within 2 weeks prior to enrollment.
<br>18.Evidence or history of any bleeding diathesis, irrespective of severity.
<br>19.Participants with a significant acute or chronic medical or psychiatric illness (other than the underlying cancer for participants in Path A, B and C) that, in the opinion of the investigator, precludes study participation (e.g., participation poses a major health risk for the participant, renders the participant unable to meet the logistic requirements of the study, or may interfere with the reliability of the participant’s study results). These conditions may include severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, respiratory disease, endocrine disorder, and neurological or psychiatric illn | Vaccination for prophylaxis of coronavirus disease 2019 (COVID-19) <br>MedDRA version: 23.1
Level: LLT
Classification code 10084464
Term: COVID-19 immunization
System Organ Class: 100000004865
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: CVnCoV<br>Product Code: CV07050101<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Zorecimeran<br>Current Sponsor code: R9515<br>Concentration unit: g/l gram(s)/litre<br>Concentration type: equal<br>Concentration number: 1-<br><br> | Timepoint(s) of evaluation of this end point: 1-2: On each vaccination day and the following 7 days <br>3: On each vaccination day and the following 28 days <br>4-7: From first injection up to 28 days after the second injection;Primary end point(s): For the primary objective (safety):<br>•The occurrence of solicited local AEs on each vaccination day and the following 7 days<br>•The occurrence of solicited systemic AEs on each vaccination day and the following 7 days<br>•The occurrence of unsolicited AEs on each vaccination day and the following 28 days<br>•The occurrence of SAEs from first injection up to 28 days after the second injection<br>•The occurrence of SAEs related to study vaccine from first injection up to 28 days after the second injection<br>•The occurrence of AESIs from first injection up to 28 days after the second injection<br>•The occurrence of AESIs related to study vaccine from first injection up to 28 days after the second injection<br>;Secondary Objective: Secondary immunogenicity<br>To evaluate the humoral immune response to the CVnCoV vaccine throughout the observation period<br><br>Secondary safety<br>To further evaluate the safety profile of the 2-dose administration of CVnCoV vaccine<br>;Main Objective: To evaluate the safety and reactogenicity<br>profile of the 2-dose administration of<br>CVnCoV vaccine | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| JPRN-jRCT1021210009 | 14 June 2021 | The safety and efficacy of COVID-19 vaccines among lung transplant recipients | The safety and efficacy of COVID-19 vaccines among lung transplant recipients: Non-randomised controlled cohort study - The safety and efficacy of COVID-19 vaccines among lung transplant recipients | | Okada Yoshinori | 04/06/2021 | 20210604 | JPRN | https://jrct.niph.go.jp/latest-detail/jRCT1021210009 | Recruiting | No | >= 20age old | Not applicable | Both | 04/06/2021 | 80 | Observational | | 4 | Japan | Takashi | Hirama | 1-1 Seiryomachi, Aoba Ward, Sendai, Miyagi 980-8574 | takashi.hirama.b5@tohoku.ac.jp | +81-22-717-7000 | Tohoku University Hospital | Inclusion criteria: Lung transplant recipients followed at Tohoku University Hospital who fullfilled the following criteria 1-4:<br>(1) 6 months after lung transplant<br>(2) no history of COVID-19 infection and COVID-19 vaccinatiaon<br>(3) 20 years old or above<br>(4) written informed consent obtained<br> <br>Controll followed at Tohoku University Hospital or Tohoku Kosai Hospital who fullfilled the following criteria 1-4:<br>(1) no history of transplantation and immunosuppresive therapy<br>(2) no history of COVID-19 infection and COVID-19 vaccinatiaon<br>(3) 20 years old or above<br>(4) written informed consent obtained | Exclusion criteria: (1) informed consent unobtained<br>(2) aged 19 years old or below | lung transplant recipients <br>lung transplant, solid organ transplant, COVID-19 | no interventions | The efficacy of COVID-19 vaccine | | | | Yes | False | | |
| → | JPRN-jRCT2031200443 | 14 June 2021 | REMAP-CAP:Randomized,Embedded,Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia Immune Modulation-2 Domain | REMAP-CAP:Randomized,Embedded,Multifactorial Adaptive Platform trial for Community-Acquired Pneumonia Immune Modulation-2 Domain - REMAP-CAP:IM-2 | | Fujitani Shigeki | 25/03/2021 | 20210325 | JPRN | https://jrct.niph.go.jp/latest-detail/jRCT2031200443 | Not Recruiting | No | >= 20age old | Not applicable | Both | 19/03/2021 | 136 | Interventional | randomized controlled trial, double blind, placebo control, parallel assignment, treatment purpose | 3 | United States of America;Japan→Japan;United States of America | Naho | Shimodaira | 2-33-5 Nihonbashi Hamacho, Chuo-ku, Tokyo, Japan | shimodaira@clinical-s.jp | +81-3-6667-0250 | Clinical Service Inc. | Inclusion criteria: SARS-CoV-2 infection is confirmed by local microbiological testing.<br>(1) Adult patients(>=20 years old) who have acute illness due to confirmed COVID infection in the moderate State, and admitted to hospital<br>(2) Given written informed consent to participate in the study from the patient (or legal representative) | Exclusion criteria: 1) Death is deemed to be imminent and inevitable during the next 24 hours AND the patient and/or a treating team is not committed to full active treatment.<br>2) Expected to be discharged from hospital today or tomorrow<br>3) >=14 days while admitted to hospital with symptoms of COVID-19<br>4) Previous participation in this REMAP within the last 90 days<br>5) Has already received any dose of one or more of any form of immune modulators during this hospitalization<br>6) Is on long-term therapy or has been randomized in a trial evaluating an immune modulation agent for confirmed COVID-19 infection<br>7) The treating clinician believes that participation in the domain would not be in the best interests of the patient<br>8) Known active current or history of mycobacterial disease<br>9) Receiving a mean dose of >0.5 mg/kg prednisone or equivalent dose of another agent in the 7 days prior to eligibility assessment, except if used as a treatment for septic shock or severe COVID-19 disease<br>10) Known pregnancy or pregnancy status unknown in female of child-bearing age<br>11) Known immunosuppressive therapy<br>12) Ongoing breastfeeding or plan to breastfeed<br>13) Known hypersensitivity to active ingredient or any of the excipients<br>14) Chemotherapy or other cancer treatment for >= 3 months<br>15) Neutrophil count < 1000/mm^3 unless believed due to COVID-19<br>16) HIV-positive patients with CD4 count <= 50/mm^3 within 4 weeks of enrollment, or end-stage processes<br>17) EF < 35%<br>18) Known severe liver disease (Child C)<br>19) Ongoing or planned use of polymyxin B, hemofiltration, endotoxin removal devices,plasma exchange, in the absence of renal impairment<br>20) Known or estimated weight greater than 150 kg | Patients with proven COVID-19 admitted to hospital, as moderate state | E5564 group : Intravenous administration is initiated with a first 26.24 mg loading dose (6.56 mg/h x 4 hours), followed by a second 13.12 mg loading dose (6.56 mg/h x 2 hours) at 12 hours, and twenty-six 6.56 mg maintenance doses (3.28 mg/h x 2 hours) one every 12 hours thereafter (total of 14 days).<br><br>Placebo group : Placebo Eritoran (D5W only) should follow the same timing (total of 14 days). | Ordinal scale that is a composite end-point that comprises mortality during the acute hospital admission and the number of whole and part study days for which the patient is alive and not requiring organ failure support(Organ failure free days) | | | | No | False | | |
| JPRN-jRCT2041210013 | 14 June 2021 | Safety and Immunogenicity of EXG-5003. | Safety and Immunogenicity of COVID-19 Vaccine EXG-5003 in Healty Japanese Adults. | | Doi Yohei | 23/04/2021 | 20210423 | JPRN | https://jrct.niph.go.jp/latest-detail/jRCT2041210013 | Not Recruiting | No | >= 20age old | <= 55age old | Both | 13/05/2021 | 60 | Interventional | randomized controlled trial, double blind, placebo control, parallel assignment, prevention purpose | 1-2 | Japan | Takenao | Koseki | 1-98 Dengakugakubo, Kutsukake, Toyoake, Aichi | aca-rspf@fujita-hu.ac.jp | +81-562-93-9407 | Fujita Health University | Inclusion criteria: -Has provided written consent for participation<br>-Age between 20 and 55<br>-Has a negative nucleic acid-based test result for SARS-CoV-2<br>-Has a negative antibody test result for SARS-CoV-2 | Exclusion criteria: -Presence of uncontrolled cardiovascular, hemetologic, respiratory, hepatic, renal, gastrointestinal, or neuropsychiatric disease<br>-Presence of diabetes mellitus<br>-Presence of active autoimmune disease<br>-Positive for HBc, HCV or HIV antibody<br>-History of anaphylactic shock<br>-History of epilepsy<br>-Presence of active malignancy<br>-Presence of lung disase (e.g., COPD, asthma)<br>-Positive urine pregnancy test within 24 hours<br>-Pregnant or lactatingPlanned pregnancy of self (if female) or partner (if male) within 90 days after administration of the trial drug<br>-If female and premenopausal, not agreeable to contraception for 90 days after second administration of the trial drug<br>-If male, not agreeable to contraception for 90 days after second administration of the trial drug<br>-Prsence of clinically relevant electrocardiogram or vital sign abnormality at screening<br>-Participated in a clinical trial of a drug or a medical device within 30 days or a biologic within 90 days<br>-Rreceived any SARS-CoV-2 vaccine<br>-Received within 90 days, or is planning to receive during the study period, an immunoglobulin or blood product<br>-Received within 180 days, or is planning to receive during the study period, a biologic product with immunosuppressive properties<br>-Received for 14 days or more within 180 days, or is planning to receive during the study period, a corticosteroid<br>-Deemed ineligible for the study as determined by the principal investigator or a co-investigator | Prevention for SARS-CoV-2 infection disease | Injection of EXG-5003 or placebo | Humoral immune response<br> -Anti-RBD antibody titers<br> -Neutralizing antibody titers methods<br>Cellular immune response<br> -FluoroSpot Assay<br> - Intracellular cytokine staining assay | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04367857 | 21 June 2021 | ARMOR Study: COVID-19 Seroprevalence Among Healthcare Workers | SARS-CoV-2 Seroprevalence Among Healthcare Workers: ARMOR Study Demonstration Project | | Columbia University | 28/04/2020 | 20200428 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04367857 | Recruiting | No | 18 Years | N/A | All | April 18, 2020 | 1000 | Observational [Patient Registry] | | | United States | ; ; | Magdalena Sobieszczyk, MD, MPH;Brett Gray;Brett Gray | | ;bg2168@cumc.columbia.edu; | ;212-305-1570; | Columbia University; |
<br> Inclusion Criteria:
<br>
<br> - 18 years of age or older
<br>
<br> - NewYork-Presbyterian (NYP) healthcare personnel employee or affiliate
<br>
<br> - Understands and reads English
<br>
<br> Exclusion Criteria:
<br>
<br> - Younger than 18 years of age
<br>
<br> - Mentally and/or physically unable to complete study requirements
<br> | | Covid-19;Coronavirus Infection;Coronavirus | Other: COVID-19 Serology;Behavioral: Health Care Worker Survey | Proportion seropositive | | | | Yes | False | | |
| → | NCT04369742 | 21 June 2021 | Treating COVID-19 With Hydroxychloroquine (TEACH) | Treating COVID-19 With Hydroxychloroquine: A Multicenter Randomized, Double-blind, Placebo-controlled Clinical Trial in Hospitalized Adults | | NYU Langone Health | 25/04/2020 | 20200425 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04369742 | Not recruiting | No | 18 Years | N/A | All | April 15, 2020 | 131 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider). | Phase 2 | United States | | Mark Mulligan, MD, FIDSA | | | | NYU Langone Health |
<br> Inclusion Criteria:
<br>
<br> In order to be eligible to participate in this study, an individual must meet all of the
<br> following criteria:
<br>
<br> 1. Hospitalized adult (=18 years old) with symptoms consistent with COVID-19 including
<br> but not limited to any of the following: fever (documented or subjective), cough,
<br> dyspnea, diarrhea, nausea, diffuse myalgias, and/or anosmia
<br>
<br> 2. Informed consent signed by patient
<br>
<br> 3. Positive SARS-CoV-2 RT-PCR testing (nasopharyngeal, oropharyngeal, sputum and/or
<br> bronchoalveolar lavage) o The testing may:
<br>
<br> - Occur up to =72h prior to informed consent of participation in the study
<br>
<br> - Be undertaken either on-site or in an external laboratory certified by New York
<br> State to run testing for SARS-CoV-2
<br>
<br> Exclusion Criteria
<br>
<br> An individual who meets any of the following criteria will be excluded from participation
<br> in this study:
<br>
<br> 1. Presence of the primary endpoint (ICU admission, mechanical ventilation, ECMO, and/or
<br> vasopressor requirement) at time of randomization.
<br>
<br> 2. Treatment with CQ or HCQ within the 30 days prior to the start of the study drug
<br> treatment.
<br>
<br> 3. Participation in a clinical trial to investigate a non-FDA approved drug with the
<br> intent to treat SARS-CoV-2 within the 30 days prior to the start of the study drug
<br> treatment.
<br>
<br> 4. Unable to take oral medications.
<br>
<br> 5. History of allergic reaction or intolerance to CQ or HCQ.
<br>
<br> 6. Baseline corrected qT interval >470 milliseconds (male) or >480 milliseconds (female),
<br> history of congenital qT prolongation, and/or history of cardiac arrest.
<br>
<br> 7. Concomitant therapy with flecainide, amiodarone, digoxin, procainamide, propafenone,
<br> thioridazine, or pimozide
<br>
<br> 8. History of retinal disease including a documented history of diabetic retinopathy.
<br>
<br> 9. Known history of G6PD deficiency.
<br> | | COVID-19 | Drug: Hydroxychloroquine (HCQ);Other: Pacebo: Calcium citrate | Cumulative incidence of SAEs through day 30;Cumulative incidence of grade 3 or 4 AEs through day 30;Severe disease progression composite outcome;Incidence of discontinuation of therapy (for any reason)→Cumulative incidence of SAEs through day 30;Cumulative incidence of grade 3 or 4 AEs through day 30;Incidence of discontinuation of therapy (for any reason);Severe disease progression composite outcome | | | | Yes | False | | |
| NCT04373733 | 21 June 2021 | Early Intervention in COVID-19: Favipiravir Verses Standard Care | A Randomised Controlled Trial of Early Intervention in Patients HospItalised With COVID-19: Favipiravir and StaNdard Care vErsEs Standard CaRe | PIONEER | Chelsea and Westminster NHS Foundation Trust | 01/05/2020 | 20200501 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04373733 | Not recruiting | No | 18 Years | N/A | All | May 1, 2020 | 502 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | United Kingdom;Mexico;Brazil;United Kingdom;Mexico;Brazil | | Pallav Shah | | | | Chelsea and Westminster NHS Foundation Trust |
<br> Inclusion Criteria:
<br>
<br> 1. Adult participants: Signed informed consent
<br>
<br> 2. New admission to hospital for period expected to last = 1 night
<br>
<br> 3. Suspected or confirmed COVID-19 infection
<br>
<br> Patients are suspected of COVID-19 infection if they have the following:
<br>
<br> · Influenza like illness (fever =37.8°C and at least one of the following respiratory
<br> symptoms, which must be of acute onset: persistent cough, hoarseness, nasal discharge
<br> or congestion, shortness of breath, sore throat, wheezing or sneezing).
<br>
<br> And
<br>
<br> · Finding from either a chest x-ray or CT suggestive of Covid-19 infection
<br>
<br> And
<br>
<br> · Alternative causes are considered unlikely
<br>
<br> 4. For women to be eligible to enter and participate in the study they should be: of
<br> non-child-bearing
<br>
<br> - potential defined as either post-menopausal (12 months of spontaneous amenorrhea
<br> and = 45 years of age) or physically incapable of becoming pregnant with
<br> documented tubal ligation, hysterectomy or bilateral oophorectomy or,
<br>
<br> - or of child-bearing potential have a negative pregnancy test at screening and
<br> agrees to remain sexually abstinent or use a method of contraception with a
<br> failure rate of < 1% per year as indicated in Appendix B during the treatment and
<br> for a period of 7 days after the last dose. Hormonal contraceptive methods must
<br> be supplemented by a barrier method.
<br>
<br> 5. Men who are sexually active must use an adequate method of contraception as listed in
<br> Appendix B, for a period of at least 7 days after the last dose
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnant or breast feeding, due to potential teratogenicity
<br>
<br> 2. Hepatic impairment - (AST or ALT > 3.5 x upper limit of normal)
<br>
<br> 3. Presently enrolled in an interventional drug study
<br>
<br> 4. Unable to take medication via the oral or nasogastric route
<br>
<br> 5. Known sensitivity Favipiravir
<br> | | Coronavirus Infection | Drug: Favipiravir;Other: Standard of care management | Time from randomisation to a sustained clinical improvement (maintained for 24 hours) by two points on a seven-category ordinal scale or to discharge, whichever occurs first | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04426305 | 21 June 2021 | Community Health Workers Against COVID19 | Community Health Workers Against COVID19 Tackling Psychosocial Suffering Due to Physical Distancing | | University Ghent | 03/06/2020 | 20200603 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04426305 | Not recruiting | No | 18 Years | N/A | All | May 21, 2020 | 140 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Care Provider). | N/A | Belgium | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - patients recruited by family practitioners based on anticipated psychosocial impact of
<br> physical distancing measures
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients with severe psychiatric diseases (psychosis, severe depression)
<br> | | Covid 19;Social Isolation;Mental Health Impairment | Other: community health worker support;Other: care as usual | Change in patient-reported anxiety (based on the PROMIS® anxiety instrument);Change in patient-reported Ability to participate in social roles and activities (based on the PROMIS® ability to participate in social roles and activities instrument);Change in patient-reported Social Isolation (based on the PROMIS® Emotional Support instrument);Change in patient-reported Emotional Support (based on the PROMIS® Emotional Support instrument) | | | | Yes | False | | |
| → | NCT04470427 | 21 June 2021 | A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19 | A Phase 3, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Immunogenicity of mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18 Years and Older | | ModernaTX, Inc. | 11/07/2020 | 20200711 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04470427 | Not recruiting | No | 18 Years | N/A | All | July 27, 2020 | 30420 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Participants who are at high risk of SARS-CoV-2 infection, defined as adults whose
<br> locations or circumstances put them at appreciable risk of exposure to SARS-CoV-2 and
<br> COVID-19.
<br>
<br> - Understands and agrees to comply with the study procedures and provides written
<br> informed consent.
<br>
<br> - Able to comply with study procedures based on the assessment of the Investigator.
<br>
<br> - Female participants of non-childbearing potential may be enrolled in the study.
<br> Non-childbearing potential is defined as surgically sterile (history of bilateral
<br> tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as
<br> amenorrhea for =12 consecutive months prior to Screening without an alternative
<br> medical cause). A follicle-stimulating hormone (FSH) level may be measured at the
<br> discretion of the Investigator to confirm postmenopausal status.
<br>
<br> - Female participants of childbearing potential may be enrolled in the study if the
<br> participant fulfills all the following criteria:
<br>
<br> - Has a negative pregnancy test at Screening and on the day of the first dose (Day
<br> 1).
<br>
<br> - Has practiced adequate contraception or has abstained from all activities that
<br> could result in pregnancy for at least 28 days prior to the first dose (Day 1).
<br>
<br> - Has agreed to continue adequate contraception through 3 months following the
<br> second dose on Day 29.
<br>
<br> - Is not currently breastfeeding.
<br>
<br> - Healthy adults or adults with pre-existing medical conditions who are in stable
<br> condition. A stable medical condition is defined as disease not requiring significant
<br> change in therapy or hospitalization for worsening disease during the 3 months before
<br> enrollment.
<br>
<br> Additional Inclusion Criteria for Part B:
<br>
<br> Participants who were previously enrolled in the mRNA-1273-P301 study and chose to be
<br> unblinded.
<br>
<br> Exclusion Criteria:
<br>
<br> - Is acutely ill or febrile 72 hours prior to or at Screening. Fever is defined as a
<br> body temperature =38.0°Celsius/100.4°Fahrenheit. Participants meeting this criterion
<br> may be rescheduled within the relevant window periods. Afebrile participants with
<br> minor illnesses can be enrolled at the discretion of the Investigator.
<br>
<br> - Is pregnant or breastfeeding.
<br>
<br> - (Part A Only) Known history of SARS-CoV-2 infection.
<br>
<br> - Prior administration of an investigational coronavirus (SARS-CoV, Middle East
<br> Respiratory Syndrome [MERS]-CoV) vaccine or current/planned simultaneous participation
<br> in another interventional study to prevent or treat COVID-19.
<br>
<br> - (Part A Only) Demonstrated inability to comply with the study procedures.
<br>
<br> - (Part A Only) An immediate family member or household member of this study's
<br> personnel.
<br>
<br> - Known or suspected allergy or history of anaphylaxis, urticaria, or other significant
<br> adverse reaction to the vaccine or its excipients.
<br>
<br> - Bleeding disorder considered a contraindication to intramuscular injection or
<br> phlebotomy.
<br>
<br> - Has received or plans to receive a vaccine within 28 days prior to the first dose (Day
<br> 1) or plans to receive a non-study vaccine within 28 days prior to or after any dose
<br> of investigational product (except for seasonal influenza vaccine).
<br>
<br> - Has participated in an interventional clinical study within 28 days prior to the day
<br> of enrollment.
<br>
<br> - Immunosuppressive or immunodeficient state, including human immunodeficiency virus
<br> (HIV) infection, asplenia, and recurrent severe infections.
<br>
<br> - Has received systemic immunosuppressants or immune-modifying drugs for >14 days in
<br> total within 6 months prior to Screening (for corticosteroids =20 milligram (mg)/day
<br> of prednisone equivalent).
<br>
<br> - Has received systemic immunoglobulins or blood products within 3 months prior to the
<br> day of Screening.
<br>
<br> - Has donated =450 milliliters (mL) of blood products within 28 days prior to Screening.
<br> | | SARS-CoV-2 | Biological: mRNA-1273;Biological: Placebo | Safety: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs);Safety: Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal;Efficacy: Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of mRNA-1273;Safety: Number of Participants with Serious AEs (SAEs);Safety: Number of Participants with Unsolicited AEs→Safety: Number of Participants with Serious AEs (SAEs);Safety: Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs);Safety: Number of Participants with Adverse Events (AEs) or Medically Attended AEs (MAAEs) Leading to Withdrawal;Efficacy: Number of Participants with a First Occurrence of COVID-19 Starting 14 Days after Second Dose of mRNA-1273;Safety: Number of Participants with Unsolicited AEs | | | | Yes | False | | |
| NCT04471051 | 21 June 2021 | An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients | An Observational Cohort Trial of Outcomes and Antibody Responses Following Treatment With COVID19 Convalescent Plasma in Hospitalized COVID-19 Patients | | University of Colorado, Denver | 13/07/2020 | 20200713 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04471051 | Not recruiting | No | 18 Years | N/A | All | April 30, 2020 | 255 | Observational | | | United States | | John D Beckham, MD | | | | University of Colorado, Denver |
<br> Inclusion Criteria:
<br>
<br> - Age 18 years or older
<br>
<br> - Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19
<br> SARS-CoV-2 RT-PCR testing.
<br>
<br> - Patient treated with COVID19 convalescent plasma.
<br>
<br> - Patient or surrogate designated decision maker is willing and able to provide written
<br> informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Receipt of pooled immunoglobulin in past 30 days
<br>
<br> - Contraindication to transfusion or history of prior reactions to transfusion blood
<br> products
<br> | | Covid19 | | Inpatient Mortality;Requirement for mechanical ventilation;Transfer to ICU;ICU Mortality;ICU Length of Stay (LOS);Hospital Mortality;Hospital Length of Stay (LOS) | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04842292 | 21 June 2021 | Nebulized Heparin for COVID19-associated Acute Respiratory Failure | Utilization of Nebulized Heparin for Patients Receiving Mechanical Ventilation for COVID19-associated Acute Respiratory Failure | | Brittany Bissell | 08/04/2021 | 20210408 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04842292 | Recruiting | No | 18 Years | 80 Years | All | May 20, 2021 | 40 | Interventional | Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | ; ; | Brittany D Bissell;Brittany D Bissell;Brittany Bissell | | ;brittany.bissell@uky.edu;brittany.bissell@uky.edu | ;8593239308; | University of Kentucky; |
<br> Inclusion Criteria:
<br>
<br> Patients admitted with confirmed COVID-19 receiving mechanical ventilation for ARDS
<br> (paO2/FiO2 ratio =300) within 48 hours
<br>
<br> Exclusion Criteria:
<br>
<br> - Allergy to heparin
<br>
<br> - Any history of heparin-induced thrombocytopenia
<br>
<br> - High risk of bleeding (platelet count < 50,000/µL or international normalized ratio >
<br> 1.5)
<br>
<br> - Patients with known bleeding disorders (i.e. hemophilia or von Willebrand Disease)
<br>
<br> - Active bleeding
<br>
<br> - Pulmonary bleeding during this hospital admission (Pulmonary bleeding is frank
<br> bleeding in the lungs, trachea or bronchi with repeated hemoptysis, or requiring
<br> repeated suctioning, and temporally associated with acute deterioration in respiratory
<br> status)
<br>
<br> - Neurosurgical procedures during this hospital admission or such procedures are planned
<br>
<br> - Epidural catheter in place
<br>
<br> - Any history of intracranial, spinal or epidural hemorrhage
<br>
<br> - Tracheostomy in place
<br>
<br> - Cervical spinal cord injury associated with reduced long-term ability to breathe
<br> independently
<br>
<br> - Spinal or peripheral nerve disease with a likely prolonged reduction in the ability to
<br> breathe independently
<br>
<br> - Receiving extra-corporeal membrane oxygenation or continuous renal replacement therapy
<br>
<br> - Usually treated with hemodialysis or peritoneal dialysis for end-stage renal failure
<br>
<br> - Death is deemed imminent or inevitable or there is an underlying disease with a life
<br> expectancy of fewer than 90 days
<br>
<br> - Pregnant or might be pregnant.
<br>
<br> - Objection from the treating clinician
<br>
<br> - Consent refused by the patient or substitute decision maker.
<br>
<br> - History of thrombosis (VTE or cardiovascular event)
<br> | | Covid19 | Drug: Heparin;Drug: Placebo | Mean PaO2/FiO2 ratio | | | | Yes | False | | |
| → | NCT04843722 | 21 June 2021 | COVID-19 Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines | Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of a Supplemental Spike & Nucleocapsid-targeted COVID-19 Vaccine to Enhance T Cell Based Immunogenicity in Participants Who Have Already Received Prime + Boost Vaccines Authorized For Emergency Use | | ImmunityBio, Inc. | 09/04/2021 | 20210409 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04843722 | Not recruiting | No | 18 Years | 80 Years | All | June 2021 | 540 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 1/Phase 2 | United States | ; | Lennie Sender, MD;Julian Blake | | lennie.sender@immunitybio.com;Julian.Blake@cssifm.org | 714-615-2350;213-266-5639 | |
<br> Inclusion Criteria:
<br>
<br> 1. Healthy adults, age = 18 years, inclusive, at time of enrollment, that have previously
<br> received an FDA-authorized COVID-19 vaccine (both prime and boost) =14 days and
<br>
<br> = 6 months before enrollment.
<br>
<br> 2. Able to understand and provide a signed informed consent that fulfills the relevant
<br> Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
<br>
<br> 3. Agrees to the collection of biospecimens (eg, NP swabs and/or saliva sample) and
<br> venous blood per protocol.
<br>
<br> 4. Ability to attend required study visits and return for adequate follow-up, as required
<br> by this protocol.
<br>
<br> 5. Ability to swallow a capsule.
<br>
<br> 6. Temperature < 38°C.
<br>
<br> 7. Agreement to practice effective contraception for female subjects of childbearing
<br> potential and non-sterile males. Female subjects of childbearing potential must agree
<br> to use effective contraception while on study until at least 1 month after the last
<br> dose of vaccine. Non-sterile male subjects must agree to use a condom while on study
<br> until at least 1 month after the last dose of vaccine. Effective contraception
<br> includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier
<br> methods (eg, condom, diaphragm) used with spermicide, IUDs, oral contraceptives, and
<br> abstinence.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Persistent grade = 2 AEs related to previous COVID-19 vaccination at the time of
<br> enrollment.
<br>
<br> 2. Allergy to any component of the investigational vaccine, or a more severe allergic
<br> reaction and history of allergies in the past.
<br>
<br> 3. Pregnant and nursing women. A negative serum or urine pregnancy test during screening
<br> and on the day of and prior to each dose must be documented before the vaccine is
<br> administered to a female subject of childbearing potential.
<br>
<br> 4. Chronic lung disease including chronic obstructive pulmonary disease (COPD) or
<br> moderate to severe asthma.
<br>
<br> 5. Pulmonary fibrosis.
<br>
<br> 6. Bone marrow or organ transplantation.
<br>
<br> 7. Extreme obesity (defined as BMI of 35 kg/m2 or higher).
<br>
<br> 8. Diabetes.
<br>
<br> 9. Chronic kidney disease.
<br>
<br> 10. Liver disease.
<br>
<br> 11. Sickle cell disease.
<br>
<br> 12. Thalassemia.
<br>
<br> 13. Any disease associated with acute fever, or any infection.
<br>
<br> 14. Self-reported history of SARS.
<br>
<br> 15. History of hepatitis B or hepatitis C.
<br>
<br> 16. HIV or other acquired or hereditary immunodeficiency.
<br>
<br> 17. Serious cardiovascular diseases, such as heart failure, coronary artery disease,
<br> cardiomyopathies, arrhythmia, conduction block, myocardial infarction, pulmonary
<br> hypertension, severe hypertension without controllable drugs, etc.
<br>
<br> 18. Cerebrovascular disease.
<br>
<br> 19. Cystic fibrosis.
<br>
<br> 20. Neurologic conditions, such as dementia.
<br>
<br> 21. Hereditary or acquired angioneurotic edema.
<br>
<br> 22. No spleen or functional asplenia.
<br>
<br> 23. Platelet disorder or other bleeding disorder that may cause injection
<br> contraindication.
<br>
<br> 24. Chronic use (more than 14 continuous days) of any medications that may be associated
<br> with impaired immune responsiveness within 3 months before administration of study
<br> vaccine. (Including, but not limited to, systemic corticosteroids exceeding 10 mg/day
<br> of prednisone equivalent, allergy injections, immunoglobulin, interferon,
<br> immunomodulators. The use of low dose topical, ophthalmic, inhaled and intranasal
<br> steroid preparations will be permitted.)
<br>
<br> 25. Prior administration of blood products in last 4 months.
<br>
<br> 26. Currently receiving treatment for cancer or history of cancer in the last five years
<br> (except basal cell carcinoma of the skin and cervical carcinoma in situ).
<br>
<br> 27. According to the judgement of investigator, various medical, psychological, social or
<br> other conditions that could affect the subjects ability to sign informed consent.
<br>
<br> 28. Assessed by the Investigator to be unable or unwilling to comply with the requirements
<br> of the protocol.
<br> | | Covid19 | Biological: hAd5-S-Fusion+N-ETSD vaccine | Phase 1 Safety: Incidence of MAAEs and SAEs;Phase 1 Safety: Incidence and severity of solicited local reactogenicity AEs;Phase 1 Safety: Incidence and severity of solicited systemic reactogenicity AEs;Phase 1 Safety: Incidence and severity of unsolicited AEs;Phase 1 Safety: Incidence of MAAEs and SAEs;Phase 1 Safety: Incidence and severity of unsolicited AEs;Phase 1 Safety: Incidence of changes of laboratory safety examinations;Phase 1 Safety: Vital Sign - Temperature;Phase 1 Safety: Vital Sign - Heart Rate;Phase 1 Safety: Vital Sign - Blood Pressure;Phase 1 Safety: Vital Sign - Respiratory Rate;Phase 2 Efficacy: Percent of subjects that show an increase in N-reactive T cells→Phase 1 Safety: Incidence of MAAEs and SAEs;Phase 1 Safety: Incidence and severity of solicited local reactogenicity AEs;Phase 1 Safety: Incidence and severity of solicited systemic reactogenicity AEs;Phase 1 Safety: Incidence of MAAEs and SAEs;Phase 1 Safety: Incidence and severity of unsolicited AEs;Phase 1 Safety: Incidence of changes of laboratory safety examinations;Phase 1 Safety: Vital Sign - Temperature;Phase 1 Safety: Vital Sign - Heart Rate;Phase 1 Safety: Vital Sign - Blood Pressure;Phase 1 Safety: Vital Sign - Respiratory Rate;Phase 2 Efficacy: Percent of subjects that show an increase in N-reactive T cells;Phase 1 Safety: Incidence and severity of unsolicited AEs | | | | Yes | False | | |
| NCT04845191 | 21 June 2021 | COVID-19 Subcutaneously and Orally Administered Supplemental Vaccine Boost to Enhance T Cell Protection in Those Who Have Already Received EUA S-Based Vaccines | Phase 1/2 Study of the Safety, Reactogenicity, and Immunogenicity of a Subcutaneously- and Orally- Administered Supplemental Spike & Nucleocapsid-targeted COVID-19 Vaccine to Enhance T Cell Based Immunogenicity in Participants Who Have Already Received Prime + Boost Vaccines Authorized For Emergency Use | | ImmunityBio, Inc. | 09/04/2021 | 20210409 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04845191 | Not recruiting | No | 18 Years | 80 Years | All | June 2021 | 540 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 1/Phase 2 | United States | ; | Lennie Sender, MD;Julian Blake | | lennie.sender@immunitybio.com;Julian.Blake@cssifm.org | 714-615-2350;213-266-5639 | |
<br> Inclusion Criteria:
<br>
<br> 1. Healthy adults, age = 18 years, inclusive, at time of enrollment, that have previously
<br> received an FDA-authorized COVID-19 vaccine (both prime and boost) =14 days and
<br>
<br> = 6 months before enrollment.
<br>
<br> 2. Able to understand and provide a signed informed consent that fulfills the relevant
<br> Institutional Review Board (IRB) or Independent Ethics Committee (IEC) guidelines.
<br>
<br> 3. Agrees to the collection of biospecimens (eg, NP swabs and/or saliva sample) and
<br> venous blood per protocol.
<br>
<br> 4. Ability to attend required study visits and return for adequate follow-up, as required
<br> by this protocol.
<br>
<br> 5. Ability to swallow a capsule.
<br>
<br> 6. Temperature < 38°C.
<br>
<br> 7. Agreement to practice effective contraception for female subjects of childbearing
<br> potential and non-sterile males. Female subjects of childbearing potential must agree
<br> to use effective contraception while on study until at least 1 month after the last
<br> dose of vaccine. Non-sterile male subjects must agree to use a condom while on study
<br> until at least 1 month after the last dose of vaccine. Effective contraception
<br> includes surgical sterilization (eg, vasectomy, tubal ligation), two forms of barrier
<br> methods (eg, condom, diaphragm) used with spermicide, IUDs, oral contraceptives, and
<br> abstinence.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Persistent grade = 2 AEs related to previous COVID-19 vaccination at the time of
<br> enrollment.
<br>
<br> 2. Allergy to any component of the investigational vaccine, or a more severe allergic
<br> reaction and history of allergies in the past.
<br>
<br> 3. Pregnant and nursing women. A negative serum or urine pregnancy test during screening
<br> and on the day of and prior to each dose must be documented before the vaccine is
<br> administered to a female subject of childbearing potential.
<br>
<br> 4. Chronic lung disease including chronic obstructive pulmonary disease (COPD) or
<br> moderate to severe asthma.
<br>
<br> 5. Pulmonary fibrosis.
<br>
<br> 6. Bone marrow or organ transplantation.
<br>
<br> 7. Extreme obesity (defined as BMI of 35 kg/m2 or higher).
<br>
<br> 8. Diabetes.
<br>
<br> 9. Chronic kidney disease.
<br>
<br> 10. Liver disease.
<br>
<br> 11. Sickle cell disease.
<br>
<br> 12. Thalassemia.
<br>
<br> 13. Any disease associated with acute fever, or any infection.
<br>
<br> 14. Self-reported history of SARS.
<br>
<br> 15. History of hepatitis B or hepatitis C.
<br>
<br> 16. HIV or other acquired or hereditary immunodeficiency.
<br>
<br> 17. Serious cardiovascular diseases, such as heart failure, coronary artery disease,
<br> cardiomyopathies, arrhythmia, conduction block, myocardial infarction, pulmonary
<br> hypertension, severe hypertension without controllable drugs, etc.
<br>
<br> 18. Cerebrovascular disease.
<br>
<br> 19. Cystic fibrosis.
<br>
<br> 20. Neurologic conditions, such as dementia.
<br>
<br> 21. Hereditary or acquired angioneurotic edema.
<br>
<br> 22. No spleen or functional asplenia.
<br>
<br> 23. Platelet disorder or other bleeding disorder that may cause injection
<br> contraindication.
<br>
<br> 24. Chronic use (more than 14 continuous days) of any medications that may be associated
<br> with impaired immune responsiveness within 3 months before administration of study
<br> vaccine. (Including, but not limited to, systemic corticosteroids exceeding 10 mg/day
<br> of prednisone equivalent, allergy injections, immunoglobulin, interferon,
<br> immunomodulators. The use of low dose topical, ophthalmic, inhaled and intranasal
<br> steroid preparations will be permitted.)
<br>
<br> 25. Prior administration of blood products in last 4 months.
<br>
<br> 26. Currently receiving treatment for cancer or history of cancer in the last five years
<br> (except basal cell carcinoma of the skin and cervical carcinoma in situ).
<br>
<br> 27. According to the judgement of investigator, various medical, psychological, social or
<br> other conditions that could affect the subjects ability to sign informed consent.
<br>
<br> 28. Assessed by the Investigator to be unable or unwilling to comply with the requirements
<br> of the protocol.
<br> | | Covid19 | Biological: hAd5-S-Fusion+N-ETSD vaccine | Phase 2 Efficacy: Percent of subjects that show an increase in N-reactive T cells;Phase 1 Safety: Vital Sign - Respiratory Rate;Phase 1 Safety: Vital Sign - Blood Pressure;Phase 1 Safety: Vital Sign - Heart Rate;Phase 1 Safety: Vital Sign - Temperature;Phase 1 Safety: Incidence of changes of laboratory safety examinations;Phase 1 Safety: Incidence and severity of unsolicited AEs;Phase 1 Safety: Incidence of MAAEs and SAEs;Phase 1 Safety: Incidence of MAAEs and SAEs;Phase 1 Safety: Incidence and severity of unsolicited AEs;Phase 1 Safety: Incidence and severity of solicited systemic reactogenicity AEs;Phase 1 Safety: Incidence and severity of solicited local reactogenicity AEs;Phase 1 Safety: Incidence of MAAEs and SAEs | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04921241 | 21 June 2021 | In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life | In Utero Exposure to SARS-CoV-2 (COVID-19) and Cardiovascular and Metabolic Endpoints in Early Life | PROSPER | Massachusetts General Hospital | 07/06/2021 | 20210607 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04921241 | Recruiting | No | 9 Months | N/A | All | June 8, 2021 | 240 | Observational | | | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Mother with or without prenatal COVID-19 who was enrolled in the MGH COVID-19
<br> Perinatal Biorepository and her child (9-24 months old)
<br>
<br> Exclusion Criteria:
<br>
<br> - Child with any history of documented COVID-19
<br>
<br> - Mother who received the COVID-19 vaccine during pregnancy with her child
<br>
<br> - Significant chronic illness in mother or child judged by the investigator to represent
<br> a contraindication to study participation
<br> | | In Utero SARS-CoV-2 Exposure | | Aortic pulse-wave velocity | | | | Yes | False | | |
| → | NCT04922788 | 21 June 2021 | Study to Evaluate the Safety, Immunogenicity, and Efficacy of Nanocovax Vaccine Against COVID-19 | a Phase 3, Adaptive, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Immunogenicity, and Efficacy of the Nanocovax Vaccine Against COVID-19 in Volunteer Subjects 18 Years of Age and Older. | | Nanogen Pharmaceutical Biotechnology Joint Stock Company | 08/06/2021 | 20210608 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04922788 | Recruiting | No | 18 Years | N/A | All | June 7, 2021 | 13000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | Vietnam | ; ; | Thuy Nguyen, MD;Nhan Ho, PhD;Men Chu, PhD | | ;clinicaltrial@nanogenpharma.com; | ;(+84) 28 7108 9688;(+84) 388 959 096 | Medical Affairs Department; |
<br> Inclusion Criteria:
<br>
<br> - Be a male or female 18 years of age or older.
<br>
<br> - For females: Be of non-childbearing potential or willing to use appropriate
<br> contraceptive measures for 30 days prior to vaccination through 6 months after
<br> completion of the vaccine series.
<br>
<br> - Willingness to provide a signed, printed, and dated informed consent form.
<br>
<br> - Able and willing to participate in all activities in the clinical trial.
<br>
<br> - Participants with HIV, HBV, HCV should have a health record, determined to be stable
<br> for 6 months prior to the screening.
<br>
<br> Exclusion Criteria:
<br>
<br> - Participants with unstable pre-existing medical conditions over the three months
<br> before enrollment (condition that has worsened to require hospitalization or
<br> significant changes in therapy).
<br>
<br> - Planned administration/administration of a vaccine not foreseen by the study protocol
<br> from within 45 days before the first dose of study vaccine.
<br>
<br> - Previous vaccination with any Covid-19 vaccine.
<br>
<br> - History of COVID-19 disease.
<br>
<br> - History of allergic reactions or anaphylaxis to previous immunizations or allergies to
<br> any components of the vaccine.
<br>
<br> - Planning to become pregnant or planning to discontinue contraceptive precautions
<br> during the vaccination phase through 6 months after the second immunization.
<br>
<br> - History of bleeding disorders/hemostasis or use of anticoagulants.
<br>
<br> - Currently having cancer or undergoing cancer treatment.
<br>
<br> - Chronic administration (defined as more than 14 days) of immunosuppressants or other
<br> immune-modifying drugs within 3 months prior to the first vaccine dose (inhaled and
<br> topical steroids are allowed).
<br>
<br> - Women who are pregnant or breastfeeding.
<br> | | SARS-CoV-2 Infection;COVID-19 | Biological: Nanocovax;Biological: Placebo | Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity;Percentage of participants reporting Serious adverse events or medically attended adverse events;Geometric mean of Anti-S IgG concentrations at each time point in a subset of participants;Geometric mean of SARS-CoV-2 serum neutralizing titers by Plaque reduction neutralization test (PRNT) at each time point in a subset of participants→Geometric mean of SARS-CoV-2 serum neutralizing titers by Plaque reduction neutralization test (PRNT) at each time point in a subset of participants;Geometric mean of Anti-S IgG concentrations at each time point in a subset of participants;Percentage of participants reporting Serious adverse events or medically attended adverse events;Number of participants who experience a first episode of virologically-confirmed {reverse transcription polymerase chain reaction (RT-PCR) positive} case of COVID-19 of any severity | | | | Yes | False | | |
| NCT04922814 | 21 June 2021 | Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19 | Comparison for the Effect of Neuromuscular Blocking Agents Versus Sedation Alone on Severe ARDS Patients Due to COVID-19 | | Assiut University | 08/06/2021 | 20210608 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04922814 | Not recruiting | No | 18 Years | 75 Years | All | August 1, 2021 | 40 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | | | Ayman Abdel Khalek Abou Glala, MD | | Aymanglala24@gmail.com | 0102 567 5901 | |
<br> Inclusion Criteria:
<br>
<br> - Severe ARDS: PaO2/FiO2 <200, resistant hypoxemia and tachypnoea (RR > 40
<br> breath/minute)
<br>
<br> - Not relieved by high frequency nasal canula or CPAP.
<br>
<br> - Need for invasive mechanical ventilation (uncooperative)
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient relatives' refusal
<br>
<br> - Not mechanically ventilated.
<br>
<br> - Combination of female, corticosteroids administration and vecuronium muscle relaxant.
<br>
<br> - Neuromuscular diseases (especially demyelinating diseases).
<br> | | COVID-19 Acute Respiratory Distress Syndrome;Sedation Complication;ICU Acquired Weakness | Drug: muscle relaxation | PaO2/FiO2 | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| ISRCTN11466448 | 21 June 2021 | A randomized trial to assess the effects of physical and mental health rehabilitation for people recovering from COVID-19 | Rehabilitation Exercise and psycholoGical support After covid-19 InfectioN (REGAIN): a multi-centre randomized controlled trial | | University Hospitals Coventry and Warwickshire NHS Trust | 23/11/2020 | 20201123 | ISRCTN | http://isrctn.com/ISRCTN11466448 | Recruiting | No | | | Both | 30/11/2020 | 535 | Interventional | Randomized; Interventional; Design type: Treatment, Education or Self-Management, Psychological & Behavioural, Complex Intervention, Physical, Rehabilitation (Treatment) | Not Applicable | United Kingdom | | | | | | | Inclusion criteria: <br> Current inclusion criteria as of 19/03/2021:<br> 1. UK resident<br> 2. Aged =18 years<br> 3. = 3 months after any UK hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support<br> 4. Substantial, as defined by the participant, COVID-19 related physical and/or mental health problems<br> 5. Access to, and ability/support to use, email, text message, internet video, including webcam and audio<br> 6. Ability to provide informed consent<br> 7. Able to understand spoken and written English or Bengali, Gujarati, Urdu, Punjabi, Mandarin themselves or with support from family/friends<br><br> Previous inclusion criteria:<br> 1. Aged =18 years<br> 2. =3 months after any hospital discharge related to COVID-19 infection, regardless of need for critical care or ventilatory support<br> 3. Substantial, as defined by the participant, COVID-19 related physical and/or mental health problems<br> 4. Access to, and ability/support to use email, text message, internet video, including webcam and audio<br> 5. Ability to provide informed consent<br> 6. Able to understand spoken and written English or Bengali, Gujarati, Urdu, Punjabi, Mandarin themselves or with support from family/friends<br> | Exclusion criteria: <br> 1. Exercise contraindicated<br> 2. Severe mental health problems preventing engagement<br> 3. Previous randomisation in the present trial<br> 4. Patient already engaging in, or planning to engage in a conflicting NHS delivered rehabilitation programme in the next 12 weeks<br> 5. A member of the same household has previously been randomised in the present trial<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> Current interventions as of 19/03/2021:<br> A multi-centre RCT testing the clinical and cost-effectiveness of an intensive, online, supervised, group, home-based rehabilitation programme that supports long-term physical and mental health recovery (REGAIN) vs. best-practice usual care for people discharged from hospital (>3/12) after COVID-19 infection.<br><br> Patients will be identified via two routes:<br><br> 1. Participant Identification Centres<br> Clinical care teams at UHCW NHS Trust and each PIC site (NHS hospital trust) will screen hospital discharge data and identify potential participants for contact by mail. The sites will send potential participants an infographic flyer and invitation letter which will direct potential participants to the study website to find out more information and to register their interest.<br><br> 2. Self Referral<br> A REC-approved infographic invitation flyer will be used to promote the study. These infographic invitation flyers will be provided to relevant primary and secondary care NHS COVID clinics for staff to hand out to potential participants. The flyers will also be displayed and available at GP practices and pharmacies. The study will be promoted through local/national media/social media, relevant charities and on the study website. People suffering from ongoing COVID-19-related symptoms following hospital discharge will be able to self-refer and to register their interest via the study website.<br><br> Further to baseline assessment, a total of 535 participants will be randomised to the REGAIN intervention or best practice usual care.<br><br> The REGAIN Intervention: Eight-week, online, supervised, home-based, exercise rehabilit | Health-related quality of life (HRQoL) measured using the PROMIS® 29+2 Profile v2.1 (PROPr) at 3 months post-randomisation | | 31/08/2022 | | Yes | False | | |
| → | ISRCTN34160010 | 21 June 2021 | A low-intervention study of pre-exposure prophylaxis (PrEP) in healthy volunteers at high risk of coronavirus (SARS-CoV-2) infection. | A low-intervention study to determine whether pre-exposure prophylaxis with low dose aerosol combination medication (ACM) can reduce SARS-CoV-2 incidence in healthcare workers exposed to routing COVID-19 positive contacts (LOWACM) | | North-Western State Medical University named after I.I. Mechnikov | 14/09/2020 | 20200914 | ISRCTN | http://isrctn.com/ISRCTN34160010 | Not Recruiting | No | | | Both | 01/06/2020 | 100 | Interventional | Low-intervention prospective open-label single-centre investigator-initiated study (Prevention) | Not Applicable | Russian Federation | Nataliya;Veronika→Veronika;Nataliya | Shvetc;Gomonova |
North-Western State Medical University named after I.I. Mechnikov (NWSMU)
41 Kirochnaya street
;
North-Western State Medical University named after I.I. Mechnikov (NWSMU)
41 Kirochnaya street
| rectorat@szgmu.ru;rectorat@szgmu.ru | +7 8123035000;+7 8123035000 | ; | Inclusion criteria: <br> 1. Willing and able to provide informed consent<br> 2. Aged 18-80 years<br> 3. Healthy volunteer<br> 4. Healthcare workers (HCWs) exposed to routine COVID-19 positive contacts<br> 5. Agrees to cooperate adequately to all aspects of the study, can understand the information provided about the study, and is willing to comply with the requirements of the study protocol<br> | Exclusion criteria: <br> 1. Detection of SARS-CoV-2 virus RNA by polymerase chain reaction (PCR) in biomaterial samples and/or positive enzyme-linked immunosorbent assay ELISA IgM and ELISA IgG to the virus<br> 2. Hypersensitivity or individual intolerance to the components of the combination therapy according to medical history<br> 4. Criteria related to the concomitant pathology<br> 5. Obviously or likely unable to understand and evaluate the information regarding this study within the process of signing the informed consent form, in particular regarding the expected risks and possible discomfort<br> 6. The inability or unwillingness to follow the rules for carrying out the study and participating in the study<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection), coronavirus Infection, coronavirus | <br> Among the full staff of HCWs at a designated COVID-19 hospital, 100 HCWs will be randomly invited to participate in the study by members of a study team in accordance with the protocol. The data from the control group will be collected retrospectively as aggregate data in accordance with local routine Covid-19 surveillance reports.<br><br> The aerosolized combination of medications is 3% inosine-glutamyl-cysteinyl-glycine disodium (inosine-glutathione) and 4% potassium chloride. The medication for each 5 min inhalation session is prepared ex tempore by mixing solutions of 1.0 ml inosine-glutathione and 0.25 ml potassium chloride. The medication is self-administered as an aerosol using a personal handheld nebulizer driven by compressed air at 0.25 ml min-1. Eligible participants receive the treatment for 14 days; four inhalation sessions per day with 4 h in between sessions.<br><br> Data on treatment adherence and adverse events are collected on day 7 and day 14, with additional follow-up information collected at day 28.<br> | <br> 1. New cases of SARS-CoV 2 infection in the treated group and untreated equal population of HCWs measured by study visits, weekly questionnaires, routine genetic tests and IgM/IgG seroconversion at 7,14, and 28 days. Statistical analyses include the assumption that up 11% of HCWs at risk will become infected if no prophylactic treatment is provided. Therefore it is expected that the investigated pre-exposure prophylaxis eliminates SARS-CoV-2 positive cases detected by genetic or immunological tests to 3% or less within 28 days study period; with alpha error rate of 0.05, beta error 0.85, and a sample size of ~100 participants in the study group.<br> 2. Occurrence of adverse events collected at 7 and 14 days<br> | | 02/09/2020 | | No | False | | |
| → | EUCTR2020-002039-31-FI | 21 June 2021 | Use of Tocilizumab in the inflammatory phase of COVID-19 / new coronavirus disease | COVIDSTORM - study protocol
COVID-19: Slavage TOcilizumab as a Rescue Measure - COVIDSTORM | | Turku University Hospitla | 28/04/2020 | 20200428 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002039-31 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 17/06/2020 | 90 | Interventional clinical trial of medicinal product | Controlled: no
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Finland | | | | | | | Inclusion criteria: <br>age > 18 years / hospitalized with COVID-19 / SpO2 </= 93%<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 45<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 45<br> | Exclusion criteria: <br>allergy to monoclonals / active tbc or obvious bact infection / long-term anti-rejection or immunomodul drugs / pregnant or lactating woman / participating in other drug clinical trials<br> | COVID-19 / new coronavirus disease <br>MedDRA version: 23.0
Level: LLT
Classification code 10084382
Term: Coronavirus disease 2019
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: RoActemra<br>Product Name: RoActemra<br>Pharmaceutical Form: Infusion<br><br> | Timepoint(s) of evaluation of this end point: day 28;Primary end point(s): clinical status at day 28;Secondary Objective: shorten ICU stay / clinical improvement / time to hospital discharge;Main Objective: avoid / shorten ICU admission→Main Objective: avoid / shorten ICU admission;Secondary Objective: shorten ICU stay / clinical improvement / time to hospital discharge;Primary end point(s): clinical status at day 28;Timepoint(s) of evaluation of this end point: day 28 | | | | Yes | True | parent | |
| EUCTR2020-001431-27-DE | 21 June 2021 | Is there a benefit in treating novel corona virus (Sars-CoV2) infections with the established antihypertensive valsartan? | Treatment of Sars-CoV2 infections (Covid-19) in patients without or with chronic kidney disease (CKD) with valsartan vs placebo, a three-armed randomized, partly blinded trial | | Klinikum St. Georg gGmbH | 07/04/2020 | 20200407 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001431-27 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 05/06/2020 | 300 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: yes
Other trial design description: partly blinded
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
Number of treatment arms in the trial: 3
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany | Geschäftsführung | | Delitzscher Str. 141 | | 004903419090 | Klinikum St. Georg gGmbH | Inclusion criteria: <br>- Patients aged over 18 years with given consent, first positive Sars-Cov2 detection within the last three days<br>- Patients with pre-existing chronic renal insufficiency in any degree of severity<br>- Patients of both gender<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 200<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 100<br> | Exclusion criteria: <br>- intolerance to RAS-I and ARB<br>- Contraindications against ACE/ARB according to current clinical standard<br>- History of falls (more than 2 falls in the last 8 weeks)<br>- Symptomatic hypotension (i.e. blood pressure < 100 mmHg systolic and/or 50 mmHg diastolic together with hypotensive symptoms)<br>- Acute renal failure from stage 2<br>- pregnancy<br> | Sars-Cov2 infection;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: VALSARTAN<br>CAS Number: 137862-53-4<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 80-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br>Pharmaceutical Form: Tablet<br><br>Trade Name: P- Tabletten Weiß 10mm Lichtenstein Tabletten <br>Pharmaceutical Form: <br><br> | Timepoint(s) of evaluation of this end point: daily;Primary end point(s): combined clinical improvement (7-category ordinal scale of clinical Status or Hospital discharge);Secondary Objective: By characterizing virus binding epitopes with relevance to a clinically relevant immune response, patient-side protein structures (Ig epitopes) can be identified, which are important for new fast and inexpensive testing possibilities and vaccination development.;Main Objective: Since there is currently no high level evidence that allows a clear evaluation of advantages or disadvantages of a RAS-system inhibiting therapy (ACE-I, ARB) the influence of RAS-influencing drugs on COVID-19 will be investigated. The randomized switch from ACE-I to ARB against retention of ACE-I will be compared. The new setting with ARB (valsartan) will be compared against the administration of placebo. | | | | Yes | True | parent | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| IRCT20200404046937N3 | 21 June 2021 | Evaluating the effect of Phyllanthus Emblica, Rosa Damascene, Marshmallow and Honey on COVID 19 | The study of the effect of herbal drug Phyllanthus Emblica, Rosa Damascene, Althaea Officinalis and Honey in patient with covid 19 referring to Ahvaz Jundishapur university of Medical Science hospitals. | | Ahvaz University of Medical Sciences | 2020-06-25 | 20200625 | IRCT | http://en.irct.ir/trial/49029 | Not Recruiting | No | 18 years | no limit | Both | 2020-06-27 | 60 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two Therapeutic groups by random method and used 6 blocks method. Individuals are the randomization unit and randomization tools are statistical soft ware, make a random sequence is by using statistical soft ware allocation concealment is by assigning unique codes, Blinding description: Double blind: Supervisor and the participants are blind to the prescription drug of the target group and the control group The drugs of both groups are distinguished in the same form. phyllanthus Emblica, Rosa damascene, Honey and Marshmallow have no significant smell and placebo will be the same color as the medicine by using allowed color. Also there is no significant difference between drug and placebo taste. The package are separated by mentioning the number. The list of numbers will be provided to the statistical consultant and then | 3 | Iran (Islamic Republic of);Iran (Islamic Republic of);Iran (Islamic Republic of) | Mehran Varnaseri Ghandali | | Razi hospital, Felestin Ave, Amanieh Ave | drvarnasseri.m@gmail.com | +98 61 3333 7446 | Ahvaz University of Medical Sciences | Inclusion criteria: Age =18 years<br>Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19<br>Lung involvement confirmed with chest imaging<br>Hospitalized with: Fever or Respiratory rate >24/min Or Cough<br>Less than 8 days since illness onset<br>Willingness of study participant to accept randomization to any assigned treatment arm<br>Acceptance of non-participation in another study before the 28th day of the study | Exclusion criteria: Receipt of any experimental treatment for COVID 19 within the 30 days prior to the time of the screening evaluation<br>Severe liver disease<br>Known allergic reaction to drugs<br>Severe renal disease<br>Pregnant or breastfeeding women<br>Transfer to another hospital within the next 72 hours | COVID 19. <br>Corona virus infection, unspecified;U07.1 | Intervention 1: Intervention group: Patients in the target group will receive the target group drug after treatment with routine medications. To prepare the target drug, 1000 g of Amla fruit is soaked in rose water and then ground, then combined with 500 g of rose petal powder, 500 g of marshmallow powder and 5 kg of honey, and the ingredients are carefully mixed together. Stir slowly to form a homogeneous composition and the final product is an oral concoction that is packaged in suitable 150 g storage cans and patients will want 5 g of this drug every 6 hours. Intervention 2: Control group: Patients will be treated with placebo after treatment with routine medications. To prepare a placebo, 3500 g of starch powder with 3500 g of sugar syrup are mixed well and with natural and authorized color, it is completely similar to the main medicine and then it is packed in 150 g packages and patients should take 5 g of medicine every 6 hours. | Viral diagnostic test. Timepoint: The first day of the study and the end of the study. Method of measurement: Polymerase chain reaction. | | | | Yes | False | | |
| → | IRCT20200509047364N1 | 21 June 2021 | Effect of erythropoietin on COVID-19 | Evaluation of the efficacy and safety of recombinant erythropoietin on the improvement of hospitalised COVID-19 patients | | Bandare-abbas University of Medical Sciences | 2020-08-09 | 20200809 | IRCT | http://en.irct.ir/trial/49282 | Recruiting | No | no limit | 65 years | Both | 2020-06-21 | 20 | interventional | Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before assigning groups to individuals eligible to participate in the study, informed consent is completed for grouping individuals.
the person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools (https://www.sealedenvelope.com/) and by permuted block randomization method.
Individualized random allocation is done in blocks with sizes 2 and 4, and with stratification based on gender.
eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or placebo group. Patient codes are then matched to randomly generated sequence information for interventions.
(randomization concealment is done by the treatment team without informing th | 2 | Iran (Islamic Republic of) | Dariush Hooshyar | | Faculty of Medicine, Pardis unit of Hormozgan University of Medical Sciences, End of Imam Hossein Blvd., Bandar Abbas, Iran | dariush.hooshyar@gmail.com | +98 990 038 7226 | Bandare-abbas University of Medical Sciences | Inclusion criteria: All definitively positive COVID-19 patients with Hb=9.<br>Having at least one of the severe symptoms of COVID-19, including tachypnea (breathing rate> 30 beats per minute), hypoxemia (O2 =93 saturation, the partial pressure ratio of arterial oxygen <300), Lung infiltration (> 50% of lung field within 24 to 48 hours), progressive lymphopenia, LDH>245 U/I, CRP>100 | Exclusion criteria: Patients with a history of coagulopathy<br>Patients with a history of thrombosis<br>Patients with a history of deep vein thrombosis<br>Patients with a history of chronic lung disease<br>Patients with a history of diabetes mellitus<br>Patients with weakened immune systems<br>Patients with a history of end stage renal disease<br>Patients with liver disease<br>Patients with a history of taking oral contraceptive pills (OCPs)<br>Patients with systolic blood pressure greater than 160 mmHg<br>Patients with diastolic blood pressure greater than 90 mmHg<br>Patients over 65 years of age<br>Patients with erythropoietin above 500<br>Patients with a history of myocardial infarction or unstable angina<br>Patients with a history of malignancy | Laboratory confirmed COVID-19. <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: Group A.: The standard drug treatment is based on the treatment protocols of the National Committee of COVID-19 and erythropoietin recombinant (EPREX Manufactured by Johnson and Johnson Pharmaceutical Company) 300 units / Kg or 4000IU as subcutaneous injection five times a day for 5 days and simultaneously Enoxaparin 1mg / kg SQ daily is also taken to prevent thrombosis. Patients' blood pressure, along with other vital signs, is checked regularly and at regular intervals. Standard drug treatment according to the treatment protocols of the National Committee for COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate:• Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician:• Caltrate tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days• Tablets (Atazanavir / Ritonavir) 300/100 One tablet daily with food or Atazanavir 400 mg daily for at least 7 days and up to 14 days. Intervention 2: Control group: Group B: The standard drug treatment is based on the treatment protocols of the National Committee for COVID-19 and the placebo(distilled water) is given as a subcutaneous injection five times a day for 5 days. Standard drug treatment according to the treatment protocols of the National Committee for COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate:• Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours | Respiratory rate. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: Pulse oximeter.;Oxygen saturation state and arterial oxygen partial pressure ratio. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: Pulse oximeter.;Patients' blood pressure. Timepoint: At the beginning of the study (before the intervention), during the intervention (5-day erythropoietin administration). Method of measurement: Sphygmomanometer.;Endogenous erythropoietin level's. Timepoint: Beginning of study (before intervention). Method of measurement: Pathobiology laboratory.;Lymphocyte count. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: pathobiology laboratory.;CRP level's. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: pathobiology laboratory.;LDH level's. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: pathobiology laboratory.;Lung infiltration status. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: chest x-ray.→Respiratory rate. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: Pulse oximeter.;Oxygen saturation state and arterial oxygen partial pressure ratio. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: Pulse oximeter.;Lung infiltration status. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: chest x-ray.;Patients' blood pressure. Timepoint: At the beginning of the study (before the intervention), during the intervention (5-day erythropoietin administration). Method of measurement: Sphygmomanometer.;Endogenous erythropoietin level's. Timepoint: Beginning of study (before intervention). Method of measurement: Pathobiology laboratory.;Lymphocyte count. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: pathobiology laboratory.;CRP level's. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: pathobiology laboratory.;LDH level's. Timepoint: At the beginning of the study (before the intervention) and day 5 after the intervention. Method of measurement: pathobiology laboratory. | | | | No | False | | |
| IRCT20200404046937N4 | 21 June 2021 | Evaluating the effect of Ivermectin on covid 19 patients | Evaluating the efficacy and safety of Ivermectin in the treatment of COVID-19 patients: A double-blind randomized controlled trial, phase II | | Ahvaz University of Medical Sciences | 2020-08-06 | 20200806 | IRCT | http://en.irct.ir/trial/49935 | Not Recruiting | No | 18 years | no limit | Both | 2020-07-30 | 60 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are divided into two Therapeutic groups by random method and used 6 blocks method. Individuals are the randomization unit and randomization tools are statistical software, make a random sequence is by using statistical software allocation concealment is by assigning unique codes, Blinding description: Double blind: Supervisor and the participants are blind to the prescription drug of the target group and the control group.The drug in both groups is exactly the same in pill form and is in exactly the same packages. The packages are distinguished only by mentioning the number and the list of numbers will be at the disposal of the statistical consultant and then the data will be analyzed. | 2 | Iran (Islamic Republic of);Iran (Islamic Republic of) | Mehran Varnasseri | | Razi hospital, Felestin Ave, Amanieh Ave | drvarnasei.m@gmail.com | +98 61 3333 7446 | Ahvaz University of Medical Sciences | Inclusion criteria: Age =18 years<br>Laboratory polymerase chain reaction (PCR) confirmed infection with COVID19<br>Hospitalized<br>Satisfaction to participate in the study<br>Acceptance of non-participation in another study before the 28th day of the study | Exclusion criteria: Patients with a history of allergic reaction to Ivermectin<br>Renal dysfunction<br>Liver dysfunction<br>Pregnancy or deciding to get pregnant or breastfeeding | COVID 19. <br>Corona virus infection, unspecified;U07.1 | Intervention 1: Intervention group: Patients in the itervetion group will receive the drug of this study after treatment with routine medications of the disease, which is 14 mg ivermectin tablet, so that the patient will receive one ivermectin tablet every 12 hours for 3 days and then at the time of discharge, Patient symptoms and laboratory data and CT scans will be reviewed. Intervention 2: Control group: Patients in the control group will receive placebo after treatment with routine medications, which is quite similar to ivermectin, in that the patient will receive one placebo pill every 12 hours for 3 days, and then at the time of discharge, Patient symptoms and laboratory data and CT scans will be reviewed.d. | Duration of hospitalization. Timepoint: Time of dyscharge. Method of measurement: Patient file.;Viral diagnostic test. Timepoint: The first day of the study. Method of measurement: Polymerase chain reaction. | | | | No | False | | |
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| IRCT20200818048444N3 | 21 June 2021 | Ivermectine effect in treatment and prophylaxis of patients and exposed idividuals with COVID-19 | Ivermectine effect in treatment of patients with COVID-19 disease | | Ministry of Health | 2021-06-20 | 20210620 | IRCT | http://en.irct.ir/trial/52565 | Not Recruiting | No | no limit | no limit | Both | 2020-12-02 | 25 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment, Randomization description: After determining the eligibility criteria and obtaining informed consent from patients, they will be assigned into the study groups using the Balanced Block Randomization method generated by the designer of the study. The size of the blocks and random sequence generation process will not be clarified for the principal investigator and other researchers so that the allocation concealment will be fully established. In addition, randomization efficacy will be tested at the end of the study and those confounding variables with imbalanced distribution across the study groups will be adjusted through the multivariable models. | 1 | Iran (Islamic Republic of) | Dr. Khalil Ansarin | | Tuberculosis and Lung Diseases Research Center, Pashmineh Building, University St. | dr.ansarin@gmail.com | +98 41 3337 8093 | Tabriz University of Medical Sciences | Inclusion criteria: Patients with diagnosis of COVID-19 disease | Exclusion criteria: History of allergy to ivermectin, and evidence for current helminthic disease<br>Advanced renal failure with GFR<30<br>Advanced liver failure<br>Advanced malignancy<br>Severe heart failure or active cardiac arrhythmia | Covid-19 Disease. <br>Covid-19 Disease;U07.1 | Intervention 1: Intervention group: 3 doses of oral ivermectin 200 µg / kg once daily for 3 doses. Intervention 2: Control group: The patients in the control group will receive the standard treatment recommended by ministry of health for this disease. | Patient mortality. Timepoint: Within 28 days after the onset of the disease. Method of measurement: Physician report.;Transfer to ICU. Timepoint: Within 28 days after the onset of the disease. Method of measurement: Physician report.;Intubation or mechanical ventilation. Timepoint: Within 28 days after the onset of the disease. Method of measurement: Physician report. | | | | No | False | | |
| → | IRCT20201220049771N1 | 21 June 2021 | study of the effectiveness of "SALIRAVIRA" as a natural product on the treatment of COVID-19 patients | Study of the effectiveness of "SALIRAVIRA" as a natural product containing Licorice, Cone flower, Ginseng, Hyssop, Rhubarb and Rosemary extracts on the recovery of COVID-19 patients | | Shahid Beheshti University of Medical Sciences | 2020-12-31 | 20201231 | IRCT | http://en.irct.ir/trial/53131 | Not Recruiting | No | 12 years | 80 years | Both | 2020-12-21 | 120 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The participants will be assigned to two groups by block randomization method. In order to minimize the probability of sequence prediction, blocks with variable (4 and 6) size will be used. The randomization ratio will be 1:1. Randomization will be done using Random allocation software. Allocation concealment will be done by assigning unique codes. | N/A | Iran (Islamic Republic of);Iran (Islamic Republic of) | Saleh Ramezani Khorshiddoust | | No. 04, 4th alley, Ghanbarzadeh St. Shahid Beheshti St., Tehran, Iran | Saleh.rkh@gmail.com | +98 21 9662 1410 | MimDaroo Pharmaceutical Co. | Inclusion criteria: Clinical confirmation of coronavirus infection<br>COVID-19 positive test reporting by RT-PCR<br>Cases with contact history with a COVID-19 patients in last 10 days<br>Lung involvement below 20% - Using CT-Scan | Exclusion criteria: Pregnancy and Lactation cases<br>Cases with malignant tumors and other acute systemic diseases or special indication<br>Patients suffering from autoimmune diseases like Psoriasis, ALS and MS<br>Patients with comorbidity of respiratory life-threatening problems<br>Addiction to drugs and alcohol<br>Participation to another clinical trial for COVID-19 | COVID-19. <br>COVID-19 virus identified;U07.1 | Intervention 1: Intervention group: Patients who receiving "SALIRAVIRA" containing mentioned extracts orally and respiratory spray at the same time in addition to standard treatments of COVID-19: 1- Oral; SALIRAVIRA tablet 750 mg; containing 500 mg of plant extracts mentioned before; 4 times daily, Once every 6 hours (tablets are packed in blisters contain 10 tablet and will be provided to each case for the duration of treatment, ie 32 tablet) All process of extraction, production and packaging done under GMP conditions in Mimdaroo pharmaceutical company. 2 - SALIRAVIRA respiratory spray (20ml), which contains plant extracts mentioned before will be used 4 times daily, once every 6 hours, spay will be used nasal or throat along with tablets. SALIRAVIRA spray contains 100mcl of plant extract per puff and its daily dose is 400 mcl based on references. All stages of production and packaging of SALIRAVIRA spray have been done under GMP conditions and in Mimdaroo Pharmaceutical company. The duration of treatment will be 8 days. Intervention 2: Control group: Patients receiving standard treatments for COVID-19 disease for 8 days. Standard treatment is determined according to the protocols and guidelines of the Ministry of Health and is performed in all centers. | Viral Clearance. Timepoint: At the beginning of the study and and 4, 8 days after intake. Method of measurement: Polymerase chain reaction (PCR).;Fever and symptoms. Timepoint: At the beginning of the study and daily during treatment after intake. Method of measurement: Using a thermometer and clinical diagnosis.;Shortness of breath. Timepoint: At the beginning of the study and daily during treatment after intake. Method of measurement: Medical diagnosis.→Shortness of breath. Timepoint: At the beginning of the study and daily during treatment after intake. Method of measurement: Medical diagnosis.;Fever and symptoms. Timepoint: At the beginning of the study and daily during treatment after intake. Method of measurement: Using a thermometer and clinical diagnosis.;Viral Clearance. Timepoint: At the beginning of the study and and 4, 8 days after intake. Method of measurement: Polymerase chain reaction (PCR). | | | | No | False | | |
| IRCT20210216050373N1 | 21 June 2021 | The effect of Spirulina platensis supplement in the treatment of coronavirus | The effect of microalga Spirulina platensis supplement on the recovery of patients with coronavirus hospitalized in the coronavirus ward and reduction of mortality due to the disease. | | Tehran University of Medical Sciences | 2021-05-28 | 20210528 | IRCT | http://en.irct.ir/trial/54375 | Recruiting | No | 18 years | 65 years | Both | 2021-03-03 | 60 | interventional | Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: At the beginning of the patient's hospitalization before the start of the study, demographic information from patients is recorded, information related to the history of specific diseases and related to anthropometrics and current disease conditions. Patients who are eligible for inclusion based on the inclusion criteria, randomly with the block randomization method that will maintain balance in the two groups are placed in two groups of intervention and placebo. Using a random block table for patients makes the randomization action equal in the two groups in total. Also, using a random block table causes patients to be equally assigned to both groups at each stage of the study. These small blocks maintain a balance between the two groups and make the number of people in each group similar. In our study, considering that there are two groups, 4 | 3 | Iran (Islamic Republic of);Iran (Islamic Republic of) | MohamadAli ZaheriBirgani | | Imam Khomeini Hospital Complex, Tohid Square, Tehran, Iran | Amzb11@protonmail.com | +98 21 6658 1583 | Pasture Institute of Iran | Inclusion criteria: Male and female patients more than 18 and less than 65.<br>The patient is stable in condition and does not need resuscitation.<br>Signed informed consent form.<br>Definitive/clinical diagnosis of coronavirus.<br>Body mass: 18.5 - 30.<br>The same treatment protocol (coronavirus) in both groups.<br>Moderate severity of the disease. | Exclusion criteria: Pregnancy or lactation.<br>Any history of drug allergy.<br>Active, clinically significant chronic illness or human immunodeficiency virus disease.<br>Significant organ dysfunctions such as renal failure, liver dysfunction, CHF, or serious and unstable cardiac condition.<br>Underlying conditions that can affect patients' ability to provide adequate data.<br>Inability or refusal to sign the informed consent.<br>Any concurrent diseases or conditions which delay wound healing (cancer, vasculitis, immunosuppressive disorders, etc.)<br>Treatment with corticosteroids, Treatment with blood thinners, immunosuppressants, radiotherapy, or chemotherapy.<br>Receiving any investigational drug within 30 days prior to screening.<br>Abnormal liver enzymes and total bilirubin > 1.5 times of normal upper limit.<br>Specific and rare diseases such as people with HIV who are not receiving antiretroviral treatment, multiple sclerosis, SLE, rheumatoid arthritis, and PKU.<br>Observation of clinical signs not previously seen in patients with coronavirus and unusual complaints from patients.<br>Severe nausea after taking medication that does not improve with routine supportive treatment is considered as an exclusion criterion. | COVID-19. <br>COVID disease;U07.02 | Intervention 1: Intervention group: Patients taking spirulina platensis supplementation. Intervention 2: Control group: Patients taking placebo. | Disease severity. Timepoint: The first day, the third day, the fifth day are the time periods for measuring the variables of our study. Method of measurement: Disease severity is measured by the relevant variables, which are: Computed Tomography scan, Lymphocyte count, Alanine transaminase, Aspartate transaminase, White Blood Cells, Erythrocyte sedimentation rate, C-Reactive Protein, Hemoglobin, Creatinine, Arterial blood gas test, Platelet, Lactate Dehydrogenase, Prothrombin Time, Patient body temperature. | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04446429 | 28 June 2021 | Anti-Androgen Treatment for COVID-19 | Anti-Androgen Treatment for COVID-19 | | Applied Biology, Inc. | 22/06/2020 | 20200622 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04446429 | Not recruiting | No | 18 Years | N/A | Male | September 15, 2020 | 268 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | N/A | Brazil | ; | Flavio A Cadegiani, MD;Andy Goren, MD | | ; | ; | Corpometria Institute;Applied Biology, Inc. |
<br> Inclusion Criteria:
<br>
<br> 1. Male age =18 years old
<br>
<br> 2. Laboratory confirmed positive SARS-CoV-2 rtPCR test within 7 days prior to
<br> randomization
<br>
<br> 3. Clinical status on the COVID-19 8-point Ordinal Scale of 1 or 2
<br>
<br> 4. Coagulation: INR = 1.5×ULN, and APTT = 1.5×ULN
<br>
<br> 5. Subject (or legally authorized representative) gives written informed consent prior to
<br> any study screening procedures
<br>
<br> 6. Subject (or legally authorized representative) agree that subject will not participate
<br> in another COVID-19 trial while participating in this study
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subject enrolled in a study to investigate a treatment for COVID-19
<br>
<br> 2. Subject taking an anti-androgen of any type including: androgen depravation therapy,
<br> 5-alpha reductase inhibitors, etc…
<br>
<br> 3. Patients who are allergic to the investigational product or similar drugs (or any
<br> excipients);
<br>
<br> 4. Subjects who have malignant tumors in the past 5 years, with the exception of
<br> completed resected basal cell and squamous cell skin cancer and completely resected
<br> carcinoma in situ of any type
<br>
<br> 5. Subjects with known serious cardiovascular diseases, congenital long QT syndrome,
<br> torsade de pointes, myocardial infarction in the past 6 months, or arterial
<br> thrombosis, or unstable angina pectoris, or congestive heart failure which is
<br> classified as New York Heart Association (NYHA) class 3 or higher, or left ventricular
<br> ejection fraction (LVEF) < 50%, QTcF > 450 ms
<br>
<br> 6. Subjects with uncontrolled medical conditions that could compromise participation in
<br> the study(e.g. uncontrolled hypertension, hypothyroidism, diabetes mellitus)
<br>
<br> 7. Known diagnosis of human immunodeficiency virus(HIV) , hepatitis C, active hepatitis
<br> B, treponema pallidum (testing is not mandatory)
<br>
<br> 8. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit
<br> of normal.
<br>
<br> 9. Estimated glomerular filtration rate (eGFR) < 30 ml/min
<br>
<br> 10. Severe kidney disease requiring dialysis
<br>
<br> 11. Subject unlikely to return for day 15 site visit for reasons other then remission
<br>
<br> 12. Subject (or legally authorized representative) not willing or unable to provide
<br> informed consent
<br> | | COVID-19;SARS-CoV2;Androgenetic Alopecia;Prostate Cancer;Benign Prostatic Hyperplasia;SARS (Severe Acute Respiratory Syndrome) | Drug: Proxalutamide;Other: Standard of Care | COVID-19 Hospitalization | 03/02/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04446429 | Yes | False | | Yes |
| → | NCT04472559 | 28 June 2021 | Acupressure for COVID-19 Related Quality of Life and Stress | Randomized Controlled Trial of Acupressure for Health-Related Quality of Life and Perception of Stress Among Health Care Providers During the COVID-19 Pandemic | | University of California, Los Angeles | 13/07/2020 | 20200713 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04472559 | Recruiting | No | 18 Years | N/A | All | June 16, 2021 | 200 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United States | ; ; | Ka-Kit Hui, MD;Ryan Abbott, MD, PhD;Ryan B Abbott, MD, PhD | | ;rabbott@mednet.ucla.edu; | ;310-794-0712; | University of California, Los Angeles; |
<br> Inclusion Criteria:
<br>
<br> - All adult patients (18 years of age and over) who are health care providers according
<br> to self-report will be eligible for participation with the exception of subjects
<br> meeting exclusion criteria as below.
<br>
<br> Exclusion Criteria:
<br>
<br> - Exclusion criteria includes subjects who are physically unable to participate (e.g.,
<br> from severe arthritis) or cognitively unable to participate (e.g., from dementia) will
<br> be excluded. Patients unable to provide their own informed consent will be excluded.
<br> Patients under the age of 18 years will be excluded. Pregnant women will be excluded.
<br> Patients who have previous training in acupressure will be excluded.
<br> | | Quality of Life;Stress | Behavioral: Self-acupressure | Perception of stress;Health Related Quality of Life→Health Related Quality of Life;Perception of stress | | | | Yes | False | | |
| NCT04476914 | 28 June 2021 | Stress Related Disorders in Family Members of COVID-19 Patients Admitted to the ICU | Psychological Distress Symptoms in Family Members of Patients With COVID-19 Respiratory Failure in Intensive Care Units | | University of Colorado, Denver | 09/07/2020 | 20200709 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04476914 | Not recruiting | No | 18 Years | N/A | All | June 29, 2020 | 330 | Observational | | | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Family members of COVID-19 positive patients admitted to the Intensive Care Unit with
<br> respiratory failure
<br>
<br> Exclusion Criteria:
<br>
<br> - Family members will be excluded if they: are under 18 or unable to complete the
<br> survey's due to language barriers
<br> | | Respiratory Failure;SARS-CoV 2;Corona Virus Infection;Post Intensive Care Unit Syndrome;Family Members;Post Traumatic Stress Disorder;Anxiety;Depression | | Symptoms of Post-Traumatic Stress Disorder (PTSD) | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04826588 | 28 June 2021 | Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY) | Randomised Evaluation of COVID-19 Therapy (RECOVERY) in Children With PIMS-TS in Switzerland (SWISSPED-RECOVERY) | | University Children's Hospital Basel | 31/03/2021 | 20210331 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04826588 | Recruiting | No | 44 Weeks | 18 Years | All | May 21, 2021 | 75 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | Switzerland | ; | Julia Bielicki, Dr. med.;Julia Bielicki, Dr. med. | | ;julia.bielicki@ukbb.ch | ;+41 61 7041212 | Paediatric Infectious Diseases and Vaccinology, Universität-Kinderspital beider Basel (UKBB); |
<br> Inclusion Criteria:
<br>
<br> - Hospitalised children (aged <18 years old)
<br>
<br> - SARS-CoV-2 infection associated disease (clinically suspected or laboratory confirmed)
<br> with evidence of single or multi-organ dysfunction (called Pediatric Multisystem
<br> Inflammatory Syndrome temporally associated with COVID-19 [PIMS-TS]).
<br>
<br> - No medical history that might, in the opinion of the attending clinician, put the
<br> patient at significant risk if he/she were to participate in the trial
<br>
<br> Exclusion Criteria:
<br>
<br> - Neonates/infants with a corrected gestational age of <= 44 weeks
<br>
<br> - If the attending clinician believes that there is a specific contra-indication to one
<br> of the active drug treatment arms or that the patient should definitely be receiving
<br> one of the active drug treatment arms, then that arm will not be available for
<br> randomisation for that patient.
<br> | | Paediatric Inflammatory Multisystem Syndrome-Temporally Associated With SARS-CoV-2 (PIMS-TS) | Drug: Methylprednisolone sodium succinate;Biological: Human normal immunoglobulin (IVIg) | Hospital length of stay | | | | Yes | False | | |
| → | NCT04832932 | 28 June 2021 | The COVID-19 Back-to-Normal Study | A Phenotypic Study of Safety, Tolerability, Reactogenicity, Immunogenicity, and Virus Shedding Potential of Emergency-Use-Authorized Vaccines Against COVID-19 | | Mebo Research, Inc. | 02/04/2021 | 20210402 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04832932 | Recruiting | No | 16 Years | N/A | All | June 15, 2021 | 1000 | Observational | | | United States;Kenya;United Kingdom;Kenya;United Kingdom;United States→United States;United Kingdom;Kenya;United Kingdom;Kenya;United States | ; | Irene Gabashvili, PhD;Maria de la Torre | | ;maria.delatorre@meboresearch.org | ;(786) 228-6880 | Mebo Research, Inc.; |
<br> Inclusion Criteria:
<br>
<br> - Individuals 16 or older at the time of consent
<br>
<br> - Intention to vaccinate and of being available for entire study period
<br>
<br> Exclusion Criteria:
<br>
<br> - Any illness or condition that in the opinion of the investigator may affect the safety
<br> of the participant or the evaluation of any study endpoint.
<br> | | COVID-19 Vaccines | Biological: COVID-19 vaccine | Adverse reactions/events | | | | Yes | False | | |
| NCT04844489 | 28 June 2021 | Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellular Response After Vaccination Against COVID-19 in Immunocompromised People | Study of the Humoral Response to SARS-CoV-2 Variants and of the Cellular Response After Vaccination Against COVID-19 in Immunocompromised People | COVIVAC-ID | Assistance Publique - Hôpitaux de Paris | 02/04/2021 | 20210402 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04844489 | Recruiting | No | 18 Years | N/A | All | April 16, 2021 | 485 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). | N/A | France | ; | Anne-Geneviève MARCELIN, MD, PhD;Olivier BENVENISTE, MD,PhD | | anne-genevieve.marcelin@aphp.fr;olivier.benveniste@aphp.fr | +33142177401;0142161088 | |
<br> Inclusion Criteria:
<br>
<br> - Age greater than or equal to 18 years
<br>
<br> - Patients eligible for BNT162b2 vaccination
<br>
<br> - Immunocompromised patients according to one of the following criteria:
<br>
<br> 1. Patients with autoimmune or autoinflammatory diseases treated
<br>
<br> 1. For at least three months
<br>
<br> 2. Having received at least 0.1 mg / kg / day of prednisone (or equivalent) for
<br> at least three months
<br>
<br> 3. Currently receiving at least 5 mg / day of prednisone in combination with an
<br> immunosuppressant (methotrexate, cyclosporine, mycophenolate mofetil,
<br> rapamycin, azathioprine, cyclophosphamide) or biotherapy (anti-B cells
<br> (rituximab and others) anti-TNF, IL- 1, IL-6R, IL-12/23, IL-17, or B7
<br> (CTLA4-Ig)) or a kinase inhibitor (Janus, Tyrosine))
<br>
<br> 2. HIV-infected patients with a CD4 count <500 / mm3 and a viral load <50 copies /
<br> ml on stable antiretroviral therapy for at least 3 months
<br>
<br> 3. Patients with multiple sclerosis treated with a disease-modifying drug for at
<br> least 3 months at a stable dose (teriflunomide, dimethyl-fumarate, fingolimod,
<br> ocrelizumab, rituximab, natalizumab)
<br>
<br> 4. Patients with solid tumors or cancers:
<br>
<br> 1. Patients who have received active cancer treatment other than chemotherapy
<br> (targeted therapy, radiotherapy, surgery, hormone therapy) in the previous
<br> month
<br>
<br> 2. Patients who have received active cancer treatment with chemotherapy (alone
<br> or in combination with immunotherapy, radiotherapy or targeted therapy) in
<br> the previous month
<br>
<br> 3. Patients who have received active oncology treatment with one or more
<br> immunotherapy (s) in combination with anti-PD1, anti-PD-L1, anti-CTLA4
<br> antibodies without chemotherapy in the previous month.
<br>
<br> 5. Solid organ transplant patients for more than 3 months who have not received a
<br> depleting T agent in the induction protocol, and for> 6 months otherwise
<br>
<br> - Life expectancy of more than 3 months
<br>
<br> - Having been informed about the study and having given their written and informed
<br> consent
<br>
<br> - Beneficiaries or beneficiaries of a social security scheme
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who may be included in more than one of the sub-cohorts
<br>
<br> - Other vaccination received in the 15 days preceding recruitment or planned in the
<br> month following the second vaccine injection
<br>
<br> - Known or suspected allergy to one of the components of the vaccine
<br>
<br> - Severe reaction after previous administration of any influenza vaccine (multiple
<br> sclerosis, Guillain-Barré syndrome)
<br>
<br> - Contact subjects of a patient with an undetected documented SARS-CoV-2 infection
<br>
<br> - Evocative signs of COVID-19
<br>
<br> - History of documented SARS-CoV-2 infection of less than 3 months (RT-PCR, Lamp PCR,
<br> antigen test)
<br>
<br> - Last outbreak of the disease less than 3 months old for patients with Multiple
<br> Sclerosis; less than a month old for patients with autoimmune or autoinflammatory
<br> diseases
<br>
<br> - For patients with HIV, transient viremia (blip) less than 3 months old
<br>
<br> - Intercurrent infection
<br>
<br> - For organ transplants, episode of cellular or humoral rejection during the 3 months
<br> preceding inclusion
<br>
<br> - Healthy volunteers
<br>
<br> - Pregnancy less than 13 weeks old according to the declaration of pregnancy
<br>
<br> - Refusal of participation by the patient
<br>
<br> - Patients subject to legal protection measures
<br> | | Autoimmune or Autoinflammatory Diseases;HIV;Multiple Sclerosis;Solid Tumors or Cancers;Solid Organ Transplant | Other: Blood samples for the study of the humoral response to SARS-CoV-2 variants and of the cellular response after vaccination against COVID-19 | Proportion of patients with a neutralizing antibody titer greater than 1/10 towards the wild strain and the English VOC 202012/01, South African 501Y.V2 variants and any other variants that may emerge | | | | Yes | False | | |
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| ISRCTN38734433 | 28 June 2021 | Better Outcomes for Everybody: a study to evaluate whether a new service delivered by community pharmacists in collaboration with physicians to asthma and COPD patients, improves disease control and is value for money, compared with usual care, during and after COVID-19 | Better Outcomes For Everybody (BOFE) evaluates the effectiveness and cost-effectiveness of a pharmacist-led intervention, delivered by community pharmacists in collaboration with physicians, in improving disease control, compared with usual care, in asthma and COPD patients during and after COVID-19: study protocol for a pragmatic, parallel randomised controlled trial | | SOFAD srl | 15/06/2021 | 20210615 | ISRCTN | http://isrctn.com/ISRCTN38734433 | Recruiting | No | | | Both | 07/01/2022 | 1000 | Interventional | Single-centre pragmatic parallel randomized controlled trial (Treatment) | Not Applicable | Italy | | | | | | | Inclusion criteria: <br> Pharmacies must have:<br> 1. A private area for private consultation with patients<br> 2. And/or telephone, smartphone, tablet or other devices allowing remote consultation with their patients if required due to COVID-19 restrictions<br> 3. An internet connection<br><br> Pharmacists must:<br> 1. Be qualified and registered with the Italian Pharmacy Board practising in Italy<br> 2. Have experiences in providing advice to patients<br> 3. Have already provided one or more services, such as blood pressure monitoring, smoking cessation, cholesterol monitoring, signposting, food intolerance testing (this will be verified during the recruitment process asking for a self-declaration)<br> 4. Be able to attend the full training session(s)<br><br> Patients must:<br> 1. Be at least 18 years of age<br> 2. Have been diagnosed with either asthma or COPD, for at least 6 months before enrolment to the study<br> 3. Have a prescription(s) for asthma/COPD medications with R03 as ATC code (Anatomical, Therapeutic Chemical Classification), or drugs for obstructive airways disease<br> | Exclusion criteria: <br> Pharmacies must be excluded if they:<br> 1. Have no internet access<br> 2. No consultation room or no telephone, smartphone, tablet or other devices allowing remote consultation with their patients if required due to COVID-19 restrictions<br> 3. Are currently involved in any other clinical pharmacy research project<br><br> Patients must be excluded if they:<br> 1. Have a terminal illness (defined as an advanced stage of a disease with an unfavourable prognosis and no known cure) as identified by the pharmacists through the prescription coding<br> 2. Are currently enrolled in another clinical trial<br> 3. Do not self-administer their medications (e.g. inhaler)<br> 4. Are not able to communicate well in Italian, both written and spoken<br> | Asthma and Chronic Obstructive Pulmonary Disease (COPD) <br>Respiratory <br>Asthma, Chronic obstructive pulmonary disease, unspecified | <br> The duration of the trial is 24 months with a 12-month follow-up. Pharmacists will encounter their patients five times, at baseline and every 3 months.<br><br> Power calculation<br> The power calculation was conducted using the z-test family, calculating the proportion of the difference between two independent groups with two-tails (48) using the dichotomised scores of ACT and CCQ: controlled (ACT =20; CCQ <2) versus non-controlled (ACT <20; CCQ =2). A 2:1 randomisation and sample size of 887 patients (591 in the IG and 296 in the CG) will be enough to detect a difference of 15% between the intervention and control group using a dichotomised score (controlled versus non-controlled) of the ACT/CCQ with a 99% power and 5% significant level. The 15% difference represents the difference between the percentage of controlled (65%) versus non-controlled (50%) patients at the end of the study. The power calculation was conducted using G*Power version 3.1.9.4; the results were assessed and confirmed by a senior statistician working at UCLan’s Clinical Trial Unit (CTU).<br><br> Pharmacist patient ratio<br> The researchers decided to round up the number for simplicity; therefore, they aim to recruit 100 pharmacists and 900 consecutive patients (asthma = 450; COPD = 450), with a pharmacist-patient ratio of 1:9, meaning that each pharmacist will recruit and follow-up nine patients.<br><br> Randomisation, allocation and sequence generation<br> The patient is the unit of randomisation and intervention.<br><br> Block size<br> The blocks equal to nine were adopted since large blocks reduce predictability but will not restrict the randomisation as closely as small blocks.<br><br> | Asthma and COPD control assessed using the Asthma Control Test (ACT score) and the Clinical COPD Questionnaire (CCQ) score at baseline and 12 months (according to the patients' disease) at 3-month intervals | | 30/06/2023 | | Yes | False | | |
| → | ISRCTN12272130 | 28 June 2021 | The comprehensive anaemia programme and personalized therapies (CAPPT) trial testing the effect of home visits, tailored iron therapy and women’s groups to reduce anaemia in pregnant women in southern Nepal | Comprehensive Anaemia Programme and Personalized Therapies (CAPPT): a non-blinded cluster-randomised controlled trial testing the effect upon haemoglobin in pregnancy of participatory learning and action women’s groups with home-counselling and tailored iron supplementation compared with standard care in southern Nepal. | | Health Research and Social Development forum (HERD) | 22/04/2021 | 20210422 | ISRCTN | http://isrctn.com/ISRCTN12272130 | Not Recruiting | No | | | Female | 13/06/2021 | 842 | Interventional | Non-blinded parallel group two-arm cluster-randomized controlled trial (Prevention) | Not Applicable | Netherlands;Nepal | Sushil;Sanju→Sanju;Sushil | Baral;Bhattarai |
HERD International
Prasuti Marg
Thapathali
;
HERD Internationa
Prasuti Marg
Thapathali
| sushil@herdint.com;sanju.bhattarai@herdint.com | +977-1-4238045;+977-9851055424 | ; | Inclusion criteria: <br> Cluster inclusion criteria:<br> 1. Cluster does not adjoin the main East-West which crosses the country Prithivi highway<br> 2. Located in the southern part of Kapilbastu district (closer to the Indian border) where there is low population heterogeneity and low forest coverage<br> 3. Rural area with no major market<br> 4. Populated by predominantly Madhesi (plains ethnicity) population since the burden of anaemia is higher in this group<br> 5. Projected population was =1100 and <3200 (although actual populations were found to be higher when the pre-trial census was conducted)<br> 6. Surrounded by a buffer zone of non-study clusters<br><br> Menstrual monitoring:<br> 1. Married woman<br> 2. Aged between 13 to 49 years<br> 3. Able to respond to questions<br> 4. Resident of study cluster (whether husband’s or parental home)<br> 5. Husband and women have not had permanent family planning (tubal ligation or vasectomy)<br> 6. Intact uterus (not had hysterectomy)<br> 7. Non-menopausal<br> 8. Has not been told by a doctor that they are infertile<br> 9. Consenting to being asked about menstrual status (to detect pregnancy) once every 4 weeks for up to 7 months<br><br> For trial enrolment and follow up<br> 1. Same inclusion criteria as for menstrual monitoring (above)<br> 2. Tested positive for pregnancy<br> 3. Less than 20 weeks’ gestation estimated from recall of last menstrual period or uterus not clearly visible above the level of the umbilicus if LMP is not recalled/not available<br> 4. Plans to live in the cluster most of pregnancy or is able to return for counselling and/or data collection<br> 5. Consents to participate in interventions (in intervention arm) and data collection<br> | Exclusion criteria: <br> 1. Woman is unable to become pregnant (is infertile, has had a hysterectomy, post-menopausal, tubal ligation or husband has had a vasectomy) or does not have a positive pregnancy test<br> 2. Aged <=12 years or >=50 years<br> 3. Not-consenting<br> 4. Unable to respond to questions<br> 5. =20 weeks’ gestation as estimated from LMP (or uterus clearly visible above the level of the umbilicus if LMP is not recalled/not available)<br> 6. Not planning to reside in the study cluster for most of her pregnancy<br> | Prevention and treatment of anaemia in pregnant women <br>Pregnancy and Childbirth | <br> Fifty-four clusters (mean population 2582; range 1299 to 4865) meeting cluster eligibility criteria, each surrounded by a buffer zone, have been allocated into two study arms of 27 clusters. Restricted randomization was applied to maximize similarity with respect to cluster size (number of eligible women), caste, religion and travel time to a public health facility. In the control arm pregnant women receive routine antenatal care as per government protocols. In the intervention arm pregnant women receive a combination of two home counselling visits plus they and their families are invited to join participatory learning and action women’s groups in their community (PLA). Home visits and PLA are delivered by six female Nutrition Assistants (NAs) who are certified auxiliary nurse midwives or staff nurses hired by the Nepal implementing organisation HERD International.<br><br> Home visiting intervention:<br> Home visits are designed to work synergistically to encourage PLA group attendance, to reach women who cannot / do not leave their homes, and to engage family members in addressing anaemia. Each home visit comprises dialogical counselling, home-based anaemia screening, and tailored IFA. The NA visits each pregnant woman twice at home, first at 12 to 21 weeks and second at 18 to 25 weeks. Ideally the gap between visits is 4 to 6 weeks, unless logistical constraints imposed by the COVID 19 pandemic disrupt activities.<br><br> Home-based tailored dialogical counselling:<br> A dialogical approach is used to engage pregnant women and their families to think critically about the causes of anaemia in pregnancy in their household and community. The NA engages pregnant women and their families in a cycle of action and r | Blood haemoglobin level is measured using a portable battery-operated electronic Haemoglobin Photometer (HemoCue Hb 301+, Angelhom, Sweden) between 28 and 32 weeks’ gestation. Note that if logistical constraints imposed by the COVID-19 pandemic disrupt follow-up haemoglobin may be measured any time from 28 weeks to delivery | | 31/10/2022 | | Yes | False | | |
| ISRCTN68832164 | 28 June 2021 | Immune response to COVID-19 vaccination in patients with autoimmune disorders on various types of immunosuppressive treatments | Humoral and cellular immune REsponse to SARS-CoV-2 vaccination in adult Patients with stable inflammatOry bowel disease or autoimmuNe hepatitis treated with different immunoSuppressive regimens: observational, prospectivE, controlled, single-center study | | Charles University | 18/03/2021 | 20210318 | ISRCTN | http://isrctn.com/ISRCTN68832164 | Recruiting | No | | | Both | 22/03/2021 | 230 | Observational | Prospective observational single-center controlled study (Prevention) | Not Applicable | Czech Republic | | | | | | | Inclusion criteria: <br> Group A: Patients with inflammatory bowel disease without immunosuppressant in maintenance therapy (50 patients)<br> Group B: Patients with inflammatory bowel disease on maintenance therapy with azathioprine (50 patients)<br> Group C: Patients with inflammatory bowel disease on biologic therapy (50 patients) (combination with azathioprine possible)<br> Group D: Patients with autoimmune hepatitis on low-dose corticosteroid maintenance therapy with or without azathioprine (50 patients)<br> Group E: Healthy volunteers (30)<br><br> Inclusion criteria common in all groups:<br> 1. Interest in SARS-CoV-2 vaccination conducted by the national vaccination program (vaccination is not part of the study)<br> 2. Signed informed consent<br> 3. Age 18 years and above<br> 4. No symptoms or positive test for SARS-CoV-2 infection in the last 2 months<br><br> Group-specific inclusion criteria:<br> Group A: Diagnosis of inflammatory bowel disease, no immunosuppressant in maintenance therapy<br> Group B: Diagnosis of inflammatory bowel disease, immunosuppressive therapy with azathioprine<br> Group C: Diagnosis of inflammatory bowel disease, biologic therapy with anti-TNF alpha (infliximab, adalimumab) with or without concomitant azathioprine<br> Group D: Diagnosis of autoimmune hepatitis, maintenance therapy with low-dose corticosteroid with or without azathioprine<br> Group E: No history of major chronic diseases, no chronic medication<br> | Exclusion criteria: <br> 1. Contraindication to SARS-CoV-2 vaccination<br> 2. Serious comorbidities (e.g. active oncological disease, terminal organ failure, severely limited life expectancy)<br> 3. Any other immunosuppressive or immunomodulatory treatment of comorbidities<br> 4. Moderate or severe activity of IBD or autoimmune hepatitis/exacerbation of disease (Crohn's disease - Harvey-Bradshaw index > 5, ulcerative colitis - partial Mayo score > 4, autoimmune hepatitis – ALT activity > 1.5 x ULN)<br> | Immune response to COVID-19 (SARS-CoV-2 infection) vaccination in patients on immunosuppressive therapy <br>Infections and Infestations | <br> This study involves no intervention. The study team does not provide SARS-CoV-2 vaccination. The researchers only observe the immune response to SARS-CoV-2 vaccination. The vaccination itself is carried out through the national vaccination program. The SARS-CoV-2 vaccination is not performed at the study site. The researchers expect that the majority of patients will be vaccinated by their general practitioners. They bear no responsibility for the administration of the vaccine and any associated complications. Throughout the study, all necessary data concerning the SARS-CoV-2 vaccination are obtained from a survey.<br><br> The study consists of a total of three visits in which the patients will fill out a questionnaire and a blood sample is collected for detection of antibodies against SARS-CoV-2, total immunoglobulin G levels, and various other immunological parameters. The initial blood sample also includes an examination of complete blood count and basic biochemistry to determine the activity of IBD or AIH, and an examination of the level of 25-hydroxyvitamin D, which plays an important role in immune functions. The initial visit and inclusion in the study must take place within 1 month before the start of SARS-CoV-2 vaccination, the second visit is scheduled 1 month after the end of vaccination and the third and last visit is scheduled 6 months after the end of vaccination.<br> | <br> 1. Demographic parameters measured using a questionnaire:<br> 1.1. Age (Visit 1)<br> 1.2. Sex (Visit 1)<br> 1.3. BMI (Visit 1, 2, 3)<br> 2. Evaluation of IBD (not in healthy controls):<br> 2.2. Cohn’s disease - disease form and location derived from medical record, disease activity assessed by Harvey Bradshaw index (Visit 1, 2, 3)<br> 2.3. Ulcerative colitis – extent derived from medical record, disease activity assessed by Partial Mayo score (Visit 1, 2, 3)<br> 2.3. Autoimmune hepatitis - activity derived from ALT level (remission defined as ALT no higher than 1.5 x ULN) (Visit 1, 2, 3)<br> 3. Treatment of disease (Visit 1, 2, 3):<br> 3.1 IBD groups A-C:<br> 3.1.1. Mesalazine dose (g/d) derived from medical record<br> 3.1.2. Azathioprine dose (mg/d) derived from medical record<br> 3.1.3. Infliximab dose 5 mg/kg or 10 mg/kg, dosing interval, BT/vaccine interval for the first and second dose of the vaccine, derived from medical record<br> 3.1.4. Adalimumab dose 40 mg/2 w or 80 mg/2 w, dosing interval, BT/vaccine interval for the first and second dose of the vaccine, derived from medical record<br> 3.2. AIH group D (Visit 1, 2, 3):<br> 3.2.1. Corticosteroid dose (mg/d) derived from medical record<br> 3.2.2. Azathioprine dose (mg/d) derived from medical record<br> 4. Laboratory parameters (group A-E):<br> 4.1. Initial blood collection up to 1 month before the start of vaccination (Visit 1):<br> 4.1.1. Complete blood count incl. white blood cell differential, assessed by standard hematologic measurement<br> 4.1.2. Biochemistry: total bilirubin, AST, ALT, GGT, ALP, albumin, CRP, Fe; assessed by standard biochemistry measurement<br> 4.1.3. Immunology and special tests: total IgG measured by nephelometry; SARS-CoV-2 IgG antibodies measured by ELISA; CD45, CD4, CD3, interferon-gamma, CD8, CD107, TNF-alpha, CD69, CD3, Ki67, CD137, CD27, CD45RO measured by flow cytometry<br> 4.2. Blood collection 1 month after the second vaccination dose (Visit 2):<br> 4.2.1. Total IgG measured by nephelometry; SARS-CoV-2 IgG antibodies measured by ELISA; CD45, CD4, CD3, interferon-gamma, CD8, CD107, TNF-alpha, CD69, CD3, Ki67, CD137, CD27, CD45RO measured by flow cytometry<br> 4.2.2. ALT in Group D assessed by standard biochemistry measurement<br> 4.3. Blood collection 6 months after the second vaccination dose (Visit 3):<br> 4.3.1. Total IgG, SARS-CoV-2 IgG antibodies measured by ELISA<br> 4.3.2. ALT in Group D assessed by standard biochemistry measurement<br> 5. SARS-CoV-2 vaccination data:<br> 5.1. History of SARS-CoV-2 infection before, during or up to 6 months after the vaccination (Visit 1, 2, 3) derived from questionnaires 2 and 3 respectively<br> 5.1.1. Date of SARS-CoV-2 infection, severity of symptoms measured by scale in questionnaire at Visit 2<br> 5.2. Adverse reaction to vaccination derived from questionnaire 2 and measured by scale in questionnaire at Visit 2<br> | | 01/04/2022 | | Yes | False | | |
| → | ISRCTN58667920 | 28 June 2021 | COVID-19 effects on the heart | Demographic, multi-morbidity and genetic impact on myocardial involvement and its recovery from COVID-19: the COVID-HEART study | | University of Leeds | 04/08/2020 | 20200804 | ISRCTN | http://isrctn.com/ISRCTN58667920 | Recruiting | No | | | Both | 01/08/2020 | 370 | Observational | Multi-centre observational cohort study (Diagnostic) | Not Applicable | United Kingdom | Kathryn;Laura→Laura;Kathryn | Somers;Jones |
Department of Cardiology
Former Ward 39
Gilbert Scott Building
Leeds General Infirmary
Great George Street
;
Leeds Institute of Cardiovascular and Metabolic Medicine
University of Leeds
| kathryn.somers@nhs.net;l.m.jones@leeds.ac.uk | +44 (0)113 3922358;+44 (0)7921121815 | ; | Inclusion criteria: <br> 1. Aged = 18 years<br> 2. Diagnosed with SARS-CoV-2 infection with a raised cardiac biomarker (Troponin)<br> | Exclusion criteria: <br> 1. Unable/unwilling to consent<br> 2. Significant renal impairment (eGFR<30ml/min/m²)<br> 3. Female participants who are pregnant, lactating or planning pregnancy during the course of the study<br> 4. Contraindications to MRI (pacemaker, intra-orbital debris, intra-orbital debris, intra-auricular implants, intracranial clips, severe claustrophobia<br> 5. Known hypersensitivity to gadolinium-based contrast agents<br> | Assessment of heart muscle damage secondary to coronavirus disease (COVID-19) in a hospitalised-recovering patient population (or those recently discharged) with raised cardiac biomarkers (troponin) <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> Current interventions, as of 10/05/2021:<br><br> Firstly, we will establish a de-identified national image repository for all heart MRI scans already performed clinically in patients with COVID-19 infection (work package 1, WP1). We will seek consent from patients in multiple NHS hospitals with moderate to severe laboratory confirmed COVID-19 infection (defined as those requiring hospital admission for >2 days or needing ventilatory assistance) to use their images in the repository. Patients will also be invited to participate in the rest of the study (WP2).<br><br> For WP2 we will enroll patients with COVID-19 infection who have had an electrocardiogram (ECG ) for clinical reasons and/or a blood test that has indicated heart muscle injury (and any participant sites from WP1 that choose to participate in the main research rest of the study). Participants will have an MRI scan (if they haven't already), complete a quality of life questionnaire and have a six-minute walk test. Patients will be required to give written consent for their original ECG data to be used for the study and to participate in this work package. This<br> will enable us to investigate how often, and in what way, the heart becomes damaged. Patients will also be asked to provide (with additional consent) an optional blood sample for genetic and immunological testing. Assuming the mean prevalence of heart muscle injury is 12 % (from previous studies) with a precision of 3.5 %, 95 % confidence level and a 10 % drop out rate, 370 patients would be required for this work package.<br><br> All participants for WP2 will be invited for a follow up visit 6 months later and will undergo a repeat ECG, heart MRI scan, an assessment of validated quality of li | <br> Effect of COVID-19 on the heart at baseline and 6 months:<br> 1. Heart abnormalities assessed using MRI<br> 2. Heart rhythm and electrical activity assessed using ECG<br> 3. Walking ability assessed using 6-min walking test<br> 4. Patient-reported health status assessed using SF-36<br> 5. Health-related quality of life assessed using EQ-5D<br> | | 31/07/2022 | | No | False | | |
| ISRCTN69546370 | 28 June 2021 | Best available treatment study for inflammatory conditions associated with COVID-19 | Best available treatment study for inflammatory syndromes associated with SARS-CoV-2 | | Imperial College London | 02/06/2020 | 20200602 | ISRCTN | http://isrctn.com/ISRCTN69546370 | Recruiting | No | | | Both | 08/06/2020 | 1800 | Observational | Observational cohort study (Treatment) | Not Applicable | United Kingdom | | | | | | | Inclusion criteria: <br> 1. Any suspected case of inflammatory condition associated with SARS-CoV-2 in all ages<br> 2. Data entry can be prospective or retrospective<br> | Exclusion criteria: There are no exclusion criteria | A spectrum of new inflammatory syndromes associated with COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> The researchers will study routinely collected non-identifiable data from patients presenting to hospitals worldwide with clearly defined clinical phenotypes.<br><br> Study size:<br> The researchers anticipate recruitment of at least 1800 in total (150 cases from the UK, 50 from the host site). In the last month, since the establishment of a case definition in the UK (RCPCH 1 May 2020), over 100 cases have been reported across the UK and numbers are continuing to rise.<br><br> Recruitment process:<br> Study information including clear guidance on which patients to enrol on the database and how to use the database will be disseminated across UK NHS hospital and internationally, through existing consortia and collaborations as well as international societies. If a centre wants to take part in the study, they will nominate a lead for their institution, who will be provided with user log-in details and a user guide for entering data onto the REDCap database. Paediatric doctors caring for children in emergency departments, wards or intensive care units will identify patients meeting the study criteria. The relevant patients can then be enrolled onto the REDCap database and data entered retrospectively.<br><br> Collection of clinical data:<br> Data will be collected systematically on any patients meeting the study criteria using an online case report form. Patients will be anonymised and identified only by the clinician reporting the case. The severity of each patient’s clinical findings, inflammatory markers and organ dysfunction will be recorded on a daily basis before and after initiation of immunomodulating agents, or during observation (if no specific treatment given). Outcomes including, tim | <br> Current primary outcome measures as of 08/04/2021:<br> 1. Composite: Inotropic support or ventilation (invasive or non-invasive) at any time from the second day post-treatment or death at any time<br> 2. Improvement on ordinal clinical severity scale at day 2 relative to day 0, comprising<br> 2.1. Discharge on or before day 2 for any patient<br> 2.2. Step down from ventilation/inotropic support/oxygen<br> 2.3. Fall in CRP from >/= 50 to < 50 mg/l<br><br> Previous primary outcome measures:<br> 1. Comparative effectiveness of different anti-inflammatory and immunomodulatory drugs in treating the inflammatory syndrome as measured by:<br> 1.1. Fall in blood inflammatory markers (CRP, pro-calcitonin, ferritin)<br> 1.2. Prevention of cardiac dysfunction (left ventricular function on echocardiogram) and coronary artery aneurysms (z-scores of coronary arteries on echocardiogram)<br> 1.3. Other long-term complications (any long-term disability not present on admission)<br><br> Data collected using an online case report form. Clinical data entered onto the online database will span the duration of each patient's hospital stay for that episode of illness.<br> | | 31/05/2022 | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04299152 | 5 July 2021 | Stem Cell Educator Therapy Treat the Viral Inflammation in COVID-19 | Clinical Application of Stem Cell Educator Therapy for the Treatment of Viral Inflammation Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) | | Throne Biotechnologies Inc. | 28/02/2020 | 20200228 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04299152 | Not recruiting | No | 18 Years | 60 Years | All | November 10, 2021 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Care Provider). | Phase 2 | | ; | Heng Li, MD,PhD;Laura Zhao | | ;connect@ThroneBio.com | ;2019880290 | Throne Biotechnologies Inc.; |
<br> Inclusion Criteria:
<br>
<br> 1. Adult patients (18 years)
<br>
<br> 2. Must have a clinical diagnosis of SARS-CoV-2, with at least one of clinical symptoms
<br> (e.g., fever =38°C, fatigue, cough) and a positive result by the reverse-transcription
<br> polymerase chain reaction (RT-PCR) testing
<br>
<br> 3. Patients must not have received any antiviral treatments known to affect SARS-CoV-2
<br>
<br> 4. Patients must agree that they are not permitted to use any other treatment to affect
<br> SARS-CoV-2 during a period of 6 months after undergoing SCE therapy
<br>
<br> 5. Adequate venous access for apheresis
<br>
<br> 6. Ability to provide informed consent
<br>
<br> 7. For female patients only, willingness to use FDA-recommended birth control
<br> (http://www.fda.gov/downloads/ForConsumers/ByAudience/ForWomen/FreePublications/UCM356
<br> 451.pdf) until 6 months post treatment.
<br>
<br> 8. Must agree to comply with all study requirements and be willing to complete all study
<br> visits
<br>
<br> Exclusion Criteria:
<br>
<br> 1. AST or ALT 2 > x upper limit of normal.
<br>
<br> 2. Abnormal bilirubin (total bilirubin > 1.2 mg/dL, direct bilirubin > 0.4 mg/dL)
<br>
<br> 3. Creatinine > 2.0 mg/dl.
<br>
<br> 4. Known coronary artery disease or EKG suggestive of coronary artery disease unless
<br> cardiac clearance for apheresis is obtained from a cardiologist.
<br>
<br> 5. Known active infection such as Hepatitis B, Hepatitis C, or Human Immunodeficiency
<br> Virus (HIV)
<br>
<br> 6. Pregnancy assessed by a positive serum pregnancy test or breastfeeding mothers
<br>
<br> 7. Use of immunosuppressive medication within one month of enrollment including but not
<br> limited to cyclosporine, tacrolimus, sirolimus, and chemotherapy.
<br>
<br> 8. Anticoagulation other than ASA.
<br>
<br> 9. Hemoglobin < 10 g/dl or platelets < 100 k/ml
<br>
<br> 10. Is unable or unwilling to provide informed consent
<br>
<br> 11. Presence of any other physical or psychological medical condition that, in the opinion
<br> of the investigator, would preclude participation
<br> | | Severe Acute Respiratory Syndrome (SARS) Pneumonia | Combination Product: Stem Cell Educator-Treated Mononuclear Cells Apheresis | Determine the number of Covid-19 patients who were unable to complete SCE Therapy | | | | Yes | False | | |
| → | NCT04327206 | 5 July 2021 | BCG Vaccination to Protect Healthcare Workers Against COVID-19 | BCG Vaccination to Reduce the Impact of COVID-19 in Healthcare Workers (BRACE) Trial | BRACE | Murdoch Childrens Research Institute | 25/03/2020 | 20200325 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04327206 | Not recruiting | Yes | 18 Years | N/A | All | March 30, 2020 | 10078 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor). | Phase 3 | United Kingdom;Spain;Netherlands;Brazil;Australia;United Kingdom;Spain;Netherlands;Brazil;Australia→Australia;Brazil;Netherlands;Spain;United Kingdom;Australia;Brazil;Netherlands;Spain;United Kingdom | | Prof Nigel Curtis | | | | Murdoch Children's Research Institute |
<br> Inclusion Criteria:
<br>
<br> - Over 18 years of age
<br>
<br> - Healthcare worker
<br>
<br> - This is defined as anyone who works in a healthcare setting or has face to face
<br> contact with patients.
<br>
<br> - Provide a signed and dated informed consent form
<br>
<br> - Australian sites only: If annual influenza vaccination is available, receiving the flu
<br> vaccine is an eligibility requirement. The flu vaccine will be required a minimum of 3
<br> days in advance of randomisation in the BRACE trial.
<br>
<br> - Pre-randomisation blood collected
<br>
<br> Exclusion Criteria:
<br>
<br> - Has any BCG vaccine contraindication
<br>
<br> - Fever or generalised skin infection (where feasible, randomisation can be delayed
<br> until cleared)
<br>
<br> - Weakened resistance toward infections due to a disease in/of the immune system
<br>
<br> - Receiving medical treatment that affects the immune response or other
<br> immunosuppressive therapy in the last year.
<br>
<br> - These therapies include systemic corticosteroids (=20 mg for =2 weeks),
<br> non-biological immunosuppressant (also known as 'DMARDS'), biological agents
<br> (such as monoclonal antibodies against tumour necrosis factor (TNF)-alpha).
<br>
<br> - People with congenital cellular immunodeficiencies, including specific
<br> deficiencies of the interferon-gamma pathway
<br>
<br> - People with malignancies involving bone marrow or lymphoid systems
<br>
<br> - People with any serious underlying illness (such as malignancy)
<br>
<br> - NB: People with cardiovascular disease, hypertension, diabetes, and/or
<br> chronic respiratory disease are eligible if not immunocompromised, and if
<br> they meet other eligibility criteria
<br>
<br> - Known or suspected HIV infection,even if they are asymptomatic or have normal
<br> immune function.
<br>
<br> - This is because of the risk of disseminated BCG infection
<br>
<br> - People with active skin disease such as eczema, dermatitis or psoriasis at or
<br> near the site of vaccination
<br>
<br> - A different adjacent site on the upper arm can be chosen if necessary
<br>
<br> - Pregnant
<br>
<br> - Although there is no evidence that BCG vaccination is harmful during
<br> pregnancy, it is a contra-indication to BCG vaccination. Therefore, we will
<br> exclude women who think they could be pregnant or are planning to become
<br> pregnant within the next month.
<br>
<br> - UK specific: Although there is no evidence that BCG vaccination is harmful
<br> during pregnancy, it is a contra-indication to BCG vaccination. Therefore,
<br> we will exclude women of childbearing potential (WOCBP) who think they could
<br> be pregnant.
<br>
<br> - Spain specific: If the patient is female, and of childbearing potential, she
<br> must have a negative pregnancy test at the time of inclusion and practice a
<br> reliable method of birth control for 30 days after receiving the BCG
<br> vaccination.
<br>
<br> - Another live vaccine administered in the month prior to randomisation
<br>
<br> - Require another live vaccine to be administered within the month following BCG
<br> randomisation
<br>
<br> - If the other live vaccine can be given on the same day, this exclusion
<br> criteria does not apply
<br>
<br> - Known anaphylactic reaction to any of the ingredients present in the BCG vaccine
<br>
<br> - Previous active TB disease
<br>
<br> - Currently receiving long term (more than 1 month) treatment with isoniazid,
<br> rifampicin or quinolone as these antibiotics have activity against Mycobacterium
<br> bovis
<br>
<br> - Previous adverse reaction to BCG vaccine (significant local reaction (abscess) or
<br> suppurative lymphadenitis)
<br>
<br> - BCG vaccine given within the last year
<br>
<br> - Have previously had a SARS-CoV-2 positive test result (positive PCR on a respiratory
<br> sample or a positive SARS-CoV-2 diagnostic antigen test approved by the local
<br> jurisdiction's public health policy)
<br>
<br> - Already part of this trial, recruited at a different site/hospital.
<br>
<br> - Participation in another COVID-19 prevention trial
<br>
<br> - Have previously received a COVID-19-specific vaccine
<br> | | Coronavirus Disease 2019 (COVID-19);Respiratory Illness;Corona Virus Infection;COVID-19 | Drug: BCG Vaccine;Drug: 0.9%NaCl | Severe COVID-19 disease incidence;COVID-19 disease incidence | | | | Yes | True | parent | |
| NCT04340349 | 5 July 2021 | Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals | Low-dose Hydroxychloroquine and Bromhexine: a Novel Regimen for COVID-19 Prophylaxis in Healthcare Professionals (ELEVATE Trial) | ELEVATE | Instituto Nacional de Rehabilitacion | 02/04/2020 | 20200402 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04340349 | Recruiting | No | 18 Years | 59 Years | All | February 1, 2021 | 214 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). | Early Phase 1 | Mexico | | Julio Granados-Montiel, MD, PhD | | | | National Institute of Rehabilitation, Mexico |
<br> Inclusion criteria
<br>
<br> - Health personnel working at INR LGII or INCMNSZ who wish to participate in the study
<br> and sign the informed consent.
<br>
<br> - Over 18 and under 60 years of age, both genders.
<br>
<br> - Contacting with suspected or confirmed SARS-CoV-2 infection.
<br>
<br> - Normal electrocardiogram.
<br>
<br> Exclusion criteria
<br>
<br> - Positive quantitative reverse transcriptase-polymerase chain reaction (qRT-PCR) test
<br> for SARS-CoV-2 at the time of inclusion.
<br>
<br> - Panel of IgG or IgM antibodies positive for SARS-CoV-2 at the time of inclusion.
<br>
<br> - Development of respiratory symptoms suspicious of SARS-CoV-2 infection during the
<br> first 7 days after treatment is initiated, confirmed by qRT-PCR and IgG or IgM
<br> antibodies postiver for SARS-CoV-2.
<br>
<br> - History of allergies to any hydroxychloroquine or bromhexine related compound or
<br> medication.
<br>
<br> - Use of immunosuppressors for any reason.
<br>
<br> - History of bone marrow transplant.
<br>
<br> - Known glucose-6-phosphate dehydrogenase deficiency.
<br>
<br> - Chronic kidney disease or glomerular filtration <20ml/min.
<br>
<br> - Use of other drugs with reported pharmacological interactions (i.e., digitalis,
<br> flecainide, amiodarone, procainamide, or propafenone).
<br>
<br> - History of long QT syndrome.
<br>
<br> - Electrocardiogram with QTc>500 msec.
<br>
<br> - Pregnant or breastfeeding personnel.
<br>
<br> - Epilepsy.
<br>
<br> - Known liver disease.
<br>
<br> - Personnel who have received the Covid-19 vaccine
<br>
<br> Elimination criteria
<br>
<br> - Personnel who decide to leave the study for any reason not related to adverse events.
<br>
<br> - Personnel with incomplete information on the primary outcome (qRT-PCR for SARS-CoV-2).
<br>
<br> - Personnel who are relocated to work in another institution.
<br>
<br> - Personnel who do not wish to participate in the study
<br> | | Hydroxychloroquine;Antimalarials;Enzyme Inhibitors;Antirheumatic Agents | Drug: Hydroxychloroquine Sulfate;Drug: Bromhexine 8 MG | Quantification of the expression of mRNA SARS-CoV-2 and presence or absence of antibodies anti-SARS-CoV-2 | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04477902 | 5 July 2021 | Long-Term Experience and Health Effects of COVID-19 | A Longitudinal, Long-Term, Observational Study of COVID-19 Experience and Health Effects | | Altura | 16/07/2020 | 20200716 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04477902 | Not recruiting | No | 18 Years | 100 Years | All | July 1, 2020 | 64 | Observational | | | United States | | Pete Fronte, MBA | | | | Altura |
<br> Inclusion Criteria:
<br>
<br> - 18 years of age or older
<br>
<br> - Any gender specification
<br>
<br> - Has consented to proceed with survey
<br>
<br> - Is able to complete the survey via email on a regular basis
<br>
<br> Exclusion Criteria:
<br>
<br> - none
<br> | | Covid19;Corona Virus Infection;Quality of Life;Risk Reduction | Other: none - observational | Longitudinal survey | | | | Yes | False | | |
| → | NCT04481516 | 5 July 2021 | Yoga in NHS Health Care Workers With COVID-19 Related Stress | Effect of Breathing-based Meditation (Sudarshan Kriya Yoga) in NHS Health Care Workers With Possible COVID-19 Related Stress and Anxiety Disorder | | Doncaster And Bassetlaw Hospitals NHS Foundation Trust | 01/07/2020 | 20200701 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04481516 | Recruiting | No | 18 Years | N/A | All | July 1, 2020 | 30 | Observational | | | United Kingdom | ; ; | Venkata D Nagarajan;Venkata D Nagarajan;Emma Adams | | ;v.nagarajan@nhs.net;dbth.clinicalresearch@nhs.net | ;00441032366666;01302 644069 | Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust; |
<br> Inclusion Criteria:
<br>
<br> - Male / Female aged over 18 years
<br>
<br> - Member of DBHFT
<br>
<br> - Score of = 5 on generalized anxiety disorder (GAD-7) questionnaire
<br>
<br> - Fully able to understand the nature of the study with sufficient chance to read PIL
<br> and commitment to participate in the online Yoga schedule
<br>
<br> - Willingness to enter data regularly by answering online questionnaire
<br>
<br> Exclusion Criteria:
<br>
<br> - Under 18 years of age
<br>
<br> - Significant other co-morbid conditions that would preclude regular Yoga practice
<br>
<br> - Chronic medical conditions necessitating hospital admission in the last 6 months or
<br> history of significant bipolar disorder
<br>
<br> - Patients taking part in other research studies during the study period
<br>
<br> - Inability to understand study requirements
<br>
<br> - Patients who have been on any form of regular Yoga schedule in the previous 6 months
<br> | | Stress | Other: Yoga | Alleviated stress 1 - short term;Alleviated stress 2 - short term;Alleviated stress 3 - short term→Alleviated stress 3 - short term;Alleviated stress 2 - short term;Alleviated stress 1 - short term | | | | Yes | False | | |
| NCT04481685 | 5 July 2021 | A Trial of Aclaris Therapeutics, Inc. (ATI)-450 in Patients With Moderate-severe Novel Coronavirus Disease 2019 (COVID-19) | A Double-blind, Randomized, Controlled Trial of ATI-450 in Patients With Moderate-severe COVID-19 | | University of Kansas Medical Center | 15/07/2020 | 20200715 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04481685 | Not recruiting | No | 18 Years | N/A | All | July 20, 2020 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider). | Phase 2 | United States | ; | Gregory Gan, MD, PhD;Deepika Polineni, MD, PhD | | ; | ; | The University of Kansas;The University of Kansas |
<br> Inclusion Criteria:
<br>
<br> - Able to comprehend and be willing to sign the Institutional Review Board
<br> (IRB)-approved subject informed consent form (ICF) prior to administration of any
<br> study-related procedures, or consent from surrogate decision maker when the above
<br> criteria cannot be met
<br>
<br> - Male or non-pregnant female adult =18 years of age at time of enrollment; female
<br> patients must have a negative serum pregnancy test at study enrollment
<br>
<br> - Has laboratory-confirmed COVID-19 coronavirus infection as determined by polymerase
<br> chain reaction (PCR), or other commercial or public health assay in oropharyngeal or
<br> nasopharyngeal testing within 14 days of hospitalization. An additional 24-hour
<br> COVID-19 PCR test will be performed at KUMC. Patients outside of KUMC will have their
<br> samples sent to KUMC as a Central Lab for test processing
<br>
<br> - Hospitalized as a result of symptoms and signs related to COVID-19 infection, and =14
<br> days since positive test
<br>
<br> - Evidence of hypoxic respiratory failure: SpO2=93% on room air, or SpO2 >93% requiring
<br> = 2 Liters (L) O2, or Pa02/Fi02 ratio <300 Millimeter of Mercury (mmHg), or tachypnea
<br> (respiratory rate > 30 breaths/min)
<br>
<br> - Evidence of pulmonary involvement by: chest imaging or pulmonary exam
<br>
<br> - Previous use of hydroxychloroquine or chloroquine is allowed in this study
<br>
<br> - Adequate organ function per laboratory tests
<br>
<br> - Females of child-bearing potential and males with partners of child-bearing potential
<br> must agree to practice sexual abstinence or to use the forms of contraception listed
<br> in Child-Bearing Potential/Pregnancy section for the duration of study participation
<br> and for 30 Days for females and 90 days for males following completion of therapy
<br>
<br> Exclusion Criteria:
<br>
<br> - Known hypersensitivity to ATI-450
<br>
<br> - History or evidence of active or latent tuberculosis or recent exposure (within last
<br> 30d) to a person with active Tb
<br>
<br> - Evidence of active, untreated bacterial infection. Patients who are treated with
<br> antibiotics for at least 72 hours, will become eligible for rescreening for trial
<br> enrollment
<br>
<br> - Active use of immunosuppressant medication(s) (i.e. anti-rejection ,immunomodulators
<br> or immunosuppressant drugs, including but not limited to IL-6 inhibitors, TNF
<br> inhibitors, anti-IL-1 agents and Janus kinase (JAK) inhibitors within 5 half-lives or
<br> 30 days (whichever is longer) prior to randomization. (Use of
<br> hydroxychloroquine/chloroquine should be discontinued)
<br>
<br> - Oncology patients who are on active chemotherapy or immunotherapy. However, oncology
<br> patients who come off active therapy prior to enrollment and have absolute neutrophil
<br> count (ANC) =1500/mmc are eligible for enrollment
<br>
<br> - Active participation in a concurrent COVID-19 clinical trial with investigative
<br> medical drug therapies. However, co-enrollment for non-investigative drug therapies
<br> will be allowed; use or re-purposing of FDA approved treatments will be considered at
<br> the discretion of the medical monitor
<br>
<br> - In the opinion of the investigator, unlikely to survive for at least 48 hours from
<br> screening or anticipate mechanical ventilation within 48 hours
<br>
<br> - Pregnancy or breast feeding
<br>
<br> - Prisoner
<br>
<br> - Intubation and ventilation at time of enrollment
<br>
<br> - Known history for HIV, hepatitis B or C infection. Patients with serologic evidence of
<br> hepatitis B vaccination (hepatitis B surface antibody without the presence of
<br> hepatitis B surface antigen) will be allowed to participate
<br>
<br> - History of a past or current medical condition that in the opinion of the treating
<br> physician would compromise patient safety (e.g. uncontrolled HIV) by participation in
<br> the study
<br> | | Covid19 | Drug: ATI-450;Drug: Placebo | Respiratory failure-free survival in participants with moderate-severe COVID-19 who are treated with ATI-450 | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04570462 | 5 July 2021 | Mild Hypothermia for COVID-19 ARDS | Application of Mild Hypothermia for COVID-19 Acute Respiratory Distress | | Northwell Health | 21/07/2020 | 20200721 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04570462 | Not recruiting | No | 18 Years | 100 Years | All | May 18, 2020 | 0 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Provision of signed and dated informed consent form from Legally Authorized
<br> Representative.
<br>
<br> 2. Stated willingness to comply with all study procedures and availability for the
<br> duration of the study
<br>
<br> 3. Male or female, aged 18 years or above
<br>
<br> 4. COVID positive
<br>
<br> 5. On mechanical ventilation with either: refractory respiratory acidosis (ph = 7.20),
<br> hypercarbia (pCO2 = 55 mmHg), refractory hypoxia (pO2/FIO2 <150), or plateau pressures
<br> >30
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Bleeding (active bleeding, platelets less than 50,000)
<br>
<br> 2. Uncontrolled cardiac arrhythmia
<br>
<br> 3. History of cryoglobulinemia, major trauma, pregnancy
<br>
<br> 4. Active non-COVID-19 infection that is not controlled with antibiotic or antifungal
<br> regimen
<br> | | COVID19 ARDS | Other: Hypothermia Via Cooling Machine- Arctic Sun 5000 | Changes in metabolic requirement during and after hypothermia | | | | Yes | False | | |
| → | NCT04572360 | 5 July 2021 | Cardiorespiratory Exercise & Chinese Medicine for Rehabilitation of Discharged Coronavirus Disease (COVID-19) Patients | Would Cardiorespiratory Exercise and Chinese Herbal Medicine Facilitate Rehabilitation Among Post-discharge Patients With COVID-19? Clinical Efficacy and Mechanisms | Covid19Reh | Hong Kong Baptist University | 27/09/2020 | 20200927 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04572360 | Recruiting | No | 18 Years | N/A | All | October 1, 2020 | 172 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). | N/A | Hong Kong | ; ; | Julien Baker, Ph.D, D.Sc;Linda Zhong;Linda Zhong, MD,PhD | | ;ldzhong0305@gmail.com;ldzhong0305@gmail.com | ;852-34116523;34116523 | Department of Sport, Physical Education and Health, Hong Kong Baptist University; |
<br> Inclusion Criteria:
<br>
<br> 1. aged 18 years and above;
<br>
<br> 2. a percentage of predicted forced vital capacity (FVC) <90%, and/or a percentage of
<br> predicted carbon monoxide diffusing capacity < 90% (King 2014);
<br>
<br> 3. able to communicate in Cantonese.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. having acute exacerbations in the 12-week preceding recruitment patients;
<br>
<br> 2. having any contraindications for exercise (e.g., physical disability, uncontrolled
<br> mental disorders, unstable heart disease, unable to perform muscle strength tests)
<br>
<br> 3. Female - Pregnant or plan to become pregnant in the next 1 year
<br>
<br> 4. Unable to communicate in Cantonese or Mandarin
<br>
<br> 5. Currently participating in other similar rehabilitation programs or research
<br> | | Coronavirus Disease (COVID-19) | Other: Cardiorespiratory Exercise;Other: Modified Bai He Gu Jin Tang | Six-Minute Walk Test (6MWT) in Cardiorespiratory Fitness Test;Blood Pressure;Heart Rate;Peripheral oxygen saturation (SpO2);Borg Dyspnea Scale;Body composition - Segmental Muscle Mass;Body composition - Body Mass Index (BMI);Body composition - Anatomical Circumferences;FVC (L) in Lung function Test using Spirometry;FEV1 (L) in Lung function Test using Spirometry;MVV (L/min) in Lung function Test using Spirometry;Fractional exhaled Nitric Oxide (FeNO);Diffusing capacity of the lungs for carbon monoxide (DLCO);Cardiopulmonary Exercise Test (CPET) - Work Rate(WR);Cardiopulmonary Exercise Test (CPET) - Breath by Breath Measurements of Minute ventilation (VE);Cardiopulmonary Exercise Test (CPET) - CO2 output (VCO2);Cardiopulmonary Exercise Test (CPET) - O2 uptake (VO2);Change in Chinese Medicine (CM) Diagnostic Pattern & Clinical Characteristics using CM Syndrome Differentiation Assessment;Change in Body Constitution Scores using Body Constitution Questionnaires Assessment→Six-Minute Walk Test (6MWT) in Cardiorespiratory Fitness Test;Blood Pressure;Heart Rate;Peripheral oxygen saturation (SpO2);Borg Dyspnea Scale;Body composition - Segmental Muscle Mass;Body composition - Body Mass Index (BMI);Body composition - Anatomical Circumferences;FVC (L) in Lung function Test using Spirometry;Change in Body Constitution Scores using Body Constitution Questionnaires Assessment;Change in Chinese Medicine (CM) Diagnostic Pattern & Clinical Characteristics using CM Syndrome Differentiation Assessment;Cardiopulmonary Exercise Test (CPET) - O2 uptake (VO2);Cardiopulmonary Exercise Test (CPET) - CO2 output (VCO2);Cardiopulmonary Exercise Test (CPET) - Breath by Breath Measurements of Minute ventilation (VE);Cardiopulmonary Exercise Test (CPET) - Work Rate(WR);Diffusing capacity of the lungs for carbon monoxide (DLCO);Fractional exhaled Nitric Oxide (FeNO);MVV (L/min) in Lung function Test using Spirometry;FEV1 (L) in Lung function Test using Spirometry | | | | Yes | False | | |
| NCT04598594 | 5 July 2021 | Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Intensive Care Unit Patients | Evaluation of the Efficacy of Nicotine Patches in SARS-CoV2 (COVID-19) Infection in Intensive Care Unit Patients | NICOVID-REA | Assistance Publique - Hôpitaux de Paris | 15/10/2020 | 20201015 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04598594 | Not recruiting | No | 18 Years | N/A | All | November 6, 2020 | 220 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 3 | France | | Alain COMBES, MD | | | | Assistance Publique - Hôpitaux de Paris |
<br> Inclusion Criteria:
<br>
<br> 1. Patient = 18 years
<br>
<br> 2. Documented diagnosis of COVID 19 (according to the tests referenced on the list
<br> published on the website : https://covid-19.sante.gouv.fr.tests)
<br>
<br> 3. Hospitalized in intensive care unit, intubated and mechanically ventilated for less
<br> than 48 hours
<br>
<br> 4. Non-smoker and non-vaping or abstinent patient for at least 12 months
<br>
<br> 5. Obtain written informed consent from a relative / relative / support person. In the
<br> absence of a close/relative/trusted person, the patient may be included according to
<br> the emergency procedure by the investigating doctor.
<br>
<br> 6. Affiliated to a social security scheme or beneficiary of such a scheme (AME excluded)
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Chronic respiratory failure defined by PaCO2> 60 mmHg in ambulatory patients
<br> (respiratory parameters at baseline).
<br>
<br> 2. Mechanical ventilation at home (non-invasive mechanical ventilation or via a
<br> tracheostomy) with the exception of CPAP / BIPAP used only for sleep apnea syndromes
<br>
<br> 3. Predictable mechanical ventilation duration <48 hours
<br>
<br> 4. Moribund patient or death expected on the day of randomization, or with a SAPS II
<br> score> 90
<br>
<br> 5. Cerebral deficiency with dilated areactive pupils or irreversible neurological
<br> pathology.
<br>
<br> 6. Other concomitant severe pathology with an estimated life expectancy of less than 1
<br> year
<br>
<br> 7. Treatment with nicotine replacement therapy or varenicline or bupropion ongoing
<br>
<br> 8. Contraindication for nicotine patches:
<br>
<br> - Pregnant or breastfeeding women
<br>
<br> - Allergy to nicotine or to one of the excipients of the transdermal patch
<br>
<br> - Generalized skin pathologies
<br>
<br> - Cerebrovascular accident or acute coronary syndrome for less than 3 months
<br>
<br> - Pheochromocytoma
<br>
<br> - Unstable or worsening angor
<br>
<br> - Severe cardiac arrhythmia (Defined by wearing an automatic implantable
<br> defibrillator)
<br>
<br> - Known severe heart failure (Defined, for this study, by systolic LV dysfunction
<br> with an LV ejection fraction (LVEF) of less than 30%)
<br>
<br> - Severe renal failure (Defined by KDIGO stage 3)
<br>
<br> - Severe hepatic impairment (Defined by a factor V <30%)
<br>
<br> - Arteriopathy obliterating of the lower limbs stage III and IV
<br>
<br> - Uncontrolled hyperthyroidism
<br>
<br> - Gastroduodenal esophagitis or ulcer undergoing treatment or active
<br>
<br> 9. Patient under guardianship or curatorship
<br>
<br> 10. Patient deprived of liberty by judicial or administrative decision
<br>
<br> 11. Patient included in another interventional trial evaluating a health product
<br> | | Covid19;SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere | Drug: Patch, Nicotine;Drug: Patch, Placebo | Mortality | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04939155 | 5 July 2021 | Methylation Effects of COV-19 Infection and Vaccinations | Measuring the DNA Methylation Effects From COVID-19 Infection and COVID-vaccinations | | TruDiagnostic | 14/06/2021 | 20210614 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04939155 | Not recruiting | No | 18 Years | N/A | All | March 10, 2021 | 60 | Observational | | | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Subjects that are healthy individuals and of any sex, ethnicity, and anyone above the
<br> age of 18 years old.
<br> | | Covid19 | Biological: SARS-CoV-2 mRNA vaccine | Methylation age clock testing;Methylation age clock testing | | | | Yes | False | | |
| → | NCT04939402 | 5 July 2021 | SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the UZ Brussel Following COVID-19 Vaccination Using an Adenoviral Vector | SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel Following COVID-19 Vaccination Using an Adenoviral Vector | | Universitair Ziekenhuis Brussel | 22/04/2021 | 20210422 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04939402 | Recruiting | No | 18 Years | N/A | All | May 5, 2021 | 200 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | Belgium | ; | Sabine Allard, phd, md;Sabine Allard, PHD, MD | | sabine.allard@uzbrussel.be;sabine.allard@uzbrussel.be | +32 2 477;3389 | |
<br> Inclusion Criteria:
<br>
<br> - Any adult employee of the UZ Brussel at T1 who has been vaccinated at the UZ Brussel
<br> with ChAdOx1 nCoV-19 vaccine between the 2nd of March and the 9th of March 2021 after
<br> participating to phase 4 of the COVEMUZ study between the 25th of January and the 12th
<br> of February and has provided a signed informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - UZ Brussel employees not active during the inclusion period (T1).
<br> | | SARS-CoV-2;Covid19 | Diagnostic Test: Serological testing | Seroconversion;Seroprevalence→Seroprevalence;Seroconversion | | | | Yes | False | | |
| NCT04939506 | 5 July 2021 | COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in SE Louisiana | COVID-19 Vaccine Education at the Point of Testing to Increase Vaccine Uptake in Vulnerable Communities in Southeastern Louisiana | | Xavier University of Louisiana. | 22/06/2021 | 20210622 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04939506 | Not recruiting | No | 18 Years | 99 Years | All | January 2022 | 375 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | United States | ; ; | Sara Al-Dahir, PharmD;Sara Al-Dahir, PharmD;Sara Al-Dahir, PharmD | | ;saaldah@xula.edu;saaldah@xula.edu | ;5045205766;504-520-5766 | Xavier University of Louisiana.; |
<br> Inclusion Criteria:
<br>
<br> - Unvaccinated adult participants, 18-99 years of age, able to provide informed consent,
<br> and to communicate in English, Spanish or Vietnamese.
<br>
<br> Exclusion Criteria:
<br>
<br> - Persons fully or partially vaccinated for COVID-19, persons with any documented
<br> allergies to components of the COVID-19 vaccines, or contraindications to receiving a
<br> COVID-19 vaccine.
<br> | | Covid19;Vaccine Refusal;Vaccine Hesitancy | Behavioral: COVID-19 Vaccine Education at the Point of COVID-19 Testing | COVID-19 Vaccine Completion | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04716998 | 12 July 2021 | Safety and the Efficacy of MesenCure for the Treatment of Pulmonary Manifestations of COVID-19 | A Controlled Study to Evaluate the Safety and Efficacy of Allogeneic MesenCure for the Treatment of Pulmonary Manifestations in Patients With COVID19 | | BonusBio Group Ltd | 17/01/2021 | 20210117 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04716998 | Recruiting | No | 18 Years | 80 Years | All | January 14, 2021 | 35 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1/Phase 2 | Israel | ; ; | Shadi Hamoud, MD;Vered Kivity, PhD, MBA;Shadi Hamoud, MD | | ;veredki@bonus-bio.com;s_hamoud@rmc.gov.il | ;972-73-2067154;972-4-7773097 | Rambam Health Care Campus; |
<br> Inclusion Criteria:
<br>
<br> 1. Patients are able and agree to sign informed consent form before any study-specific
<br> procedure.
<br>
<br> 2. Males or females, age range 18-80.
<br>
<br> 3. Female subjects are eligible only if of non-child bearing potential.
<br>
<br> 4. Documented COVID19
<br>
<br> 5. O2 Saturation of =93%
<br>
<br> 6. Stable hemodynamic condition (blood pressure of systolic <180mm Hg and diastolic
<br> <110mm Hg)
<br>
<br> 7. Evidence of COVID19-related pulmonary infiltrates on chest X-ray/thoracic tomography.
<br>
<br> Exclusion Criteria:
<br>
<br> General:
<br>
<br> 1. Pregnant or breast-feeding females.
<br>
<br> 2. History of drug abuse.
<br>
<br> 3. Heavy smokers (above 2 packages a day).
<br>
<br> 4. Subjects incapable of giving consent.
<br>
<br> Background medical conditions:
<br>
<br> 1. Known history of any significant medical disorder, which in the investigator's
<br> judgment contraindicates the subject's participation.
<br>
<br> 2. History of significant heart diseases, renal failure (estimated GFR of <30 ml/min/1.73
<br> m2 at screening), or hepatic disease (hepatic insufficiency classified as Child-Pugh B
<br> or C).
<br>
<br> 3. Known autoimmune diseases.
<br>
<br> 4. Received any investigational drug within 30 days prior to screening day (Visit 1)
<br> (Remdesivir is not considered investigational, and is not an exclusion criteria).
<br>
<br> 5. Immunocompromised condition from any reason, at screening.
<br>
<br> 6. Abnormal clinically significant laboratory test findings, as per the investigator's
<br> judgment.
<br>
<br> 7. Poorly controlled diabetic subjects (HbA1c > 9%).
<br>
<br> 8. Known active lung malignancy.
<br>
<br> Concomitant treatment:
<br>
<br> 1. Currently treated with Immunosuppressive agents other than corticosteroids used for
<br> treating COVID19.
<br>
<br> 2. Treatment for cancer (i.e. chemotherapy or radiotherapy treatment) within the last 12
<br> months.
<br>
<br> Hypersensitivity:
<br>
<br> 1. Known history of hypersensitivity to Dextran-40 (HypoThermosol®).
<br>
<br> 2. Known history of hypersensitivity to Human Serum Albumin.
<br> | | Covid19 | Biological: MesenCure | Safety of Mesencure | | | | Yes | False | | |
| → | NCT04724538 | 12 July 2021 | Inhalation Low Dose Radionuclide Therapy in Treatment COVID-19 | Inhalation Low Dose Radionuclide Therapy in Comprehensive Treatment of COVID-19 Viral Pneumonia | | National Medical Research Radiological Centre of the Ministry of Health of Russia | 29/12/2020 | 20201229 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04724538 | Not recruiting | No | 18 Years | N/A | All | October 15, 2020 | 25 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1/Phase 2 | Russian Federation | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Positive SARS-Cov-2 polymerase chain reaction (PCR)
<br>
<br> 2. CT confirmed pneumonia
<br>
<br> 3. Men and non-pregnant women = 18 y/o with early laboratory signs of cytokine storm
<br>
<br> 4. Men and non-pregnant women <65 y/o and/or with early laboratory signs of cytokine
<br> storm
<br>
<br> 5. Informed consent obtained for participation
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Age = 18
<br>
<br> 2. Severe course of COVID-19
<br>
<br> 3. Pregnant or breast-feeding females
<br>
<br> 4. Severe concomitant pathology
<br>
<br> 5. Previous and/or present treatment of oncology disease (e.g. immunotherapy)
<br>
<br> 6. Autoimmune diseases, severe cardiac disease, bone marrow and/or visceral
<br> transplantation
<br>
<br> 7. Surgical treatment and/or radiotherapy of chest pathology
<br>
<br> 8. Treatment with specific antiviral and anticytokine agents a day before inhalation
<br> procedure
<br>
<br> 9. Absence of informed consent obtained for participation
<br> | | Covid19;Pneumonia, Viral | Radiation: 99mTc-pertechnetate aerosol;Drug: 99mTc-pertechnetate aerosol | Count of White Blood Cells (WBC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Count of Red Blood Cells (RBC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Hemoglobin Count (Hb) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Percentage of Neutrophils (N) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Absolute Neutrophil Count (ANC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Absolute Lymphocyte Count (ALC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Level of D-dimer in Blood After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Level of Lactate in the Blood After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.→Level of D-dimer in Blood After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Level of Lactate in the Blood After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Absolute Lymphocyte Count (ALC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Absolute Neutrophil Count (ANC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Percentage of Neutrophils (N) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Hemoglobin Count (Hb) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Count of Red Blood Cells (RBC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia.;Count of White Blood Cells (WBC) After 99mTc-pertechnetate Aerosol Inhalation for Adverse Events Monitoring as Evaluation Safety of This Procedure in Patients With COVID-19 Viral Pneumonia. | 07/07/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04724538 | Yes | False | | Yes |
| NCT04731051 | 12 July 2021 | The Potential Use of Inhaled Hydroxychloroquine for the Treatment of COVID-19 in Cancer Patients | A Pilot, Randomized, Open-label Trial to Determine the Feasibility, Safety, Efficacy, and Pharmacokinetics of Nebulized HCQ01 for the Treatment of Patients With COVID-19 and Cancer | | King Hussein Cancer Center | 28/01/2021 | 20210128 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04731051 | Not recruiting | No | 18 Years | N/A | All | July 2021 | 28 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1/Phase 2 | Jordan | ; ; | Feras Hawari, MD;Feras Hawari, MD;Feras Hawari, MD | | ;fhawari@khcc.jo;fhawari@khcc.jo | ;00962796699092;+962796699092 | King Hussein Cancer Center; |
<br> Inclusion criteria:
<br>
<br> 1. Documented informed consent of the patient and/or legally authorized representative.
<br> Assent, when appropriate, will be obtained per institutional guidelines.
<br>
<br> 2. Male or female =18 years of age at time of enrolment.
<br>
<br> 3. History of/ or active histologically or cytologically confirmed diagnosis of
<br> hematological or solid tumor (any type, any stage and any localization).
<br>
<br> 4. Eastern Cooperative Oncology Group (ECOG) Status < or = 3 (Appendix I).
<br>
<br> 5. Patients must have an active cancer treatment or have completed therapy within 12
<br> months of initiation of protocol specified therapy. This includes:
<br>
<br> - Patients with a new cancer diagnosis who have not yet initiated cancer therapy.
<br>
<br> - Patients on active or have recently completed cancer-directed therapy including
<br> chemotherapy, targeted therapy, radiation therapy, immunotherapy or hormonal
<br> therapy amongst others which would not increase the risk of having an adverse
<br> outcome from participating in this study.
<br>
<br> 6. Currently hospitalized with laboratory-confirmed SARS-CoV-2 infection as determined by
<br> polymerase chain reaction (PCR) collected within one week prior to randomization.
<br>
<br> 7. Initial COVID-19 severity status on the WHO 11-point Ordinal Scale for Clinical
<br> Improvement = 4 ("Hospitalized; no oxygen therapy "), = 5 ("Hospitalized; oxygen by
<br> mask or nasal prongs "), or 6 ("Hospitalized; oxygen by NIV or high flow ") (Appendix
<br> II).
<br>
<br> 8. COVID-19-induced pneumonia evidenced by chest X-ray, computed tomography scan (CT
<br> scan) or magnetic resonance scan (MR scan).
<br>
<br> 9. Estimated life expectancy of at least 6 months at hospital admission for COVID-19.
<br>
<br> 10. Patients must be receiving standard of care for SARS-CoV-2.
<br>
<br> 11. Patients must have an assessment of adequate organ function within 28 days prior to
<br> enrolment, evidenced by:
<br>
<br> - Hemoglobin = 9.0 g / dL.
<br>
<br> - Leukometry> 2,000 / mm3 (> 2 10E3/ ul).
<br>
<br> - Absolute neutrophil count = 1,500 / mm3 (=1.5 10E3/ul).
<br>
<br> - Platelet count = 100,000 / mm3 (=100 10E3/ul).
<br>
<br> - Creatinine clearance = 30 mL / min. Creatinine clearance (CrCl) should be
<br> calculated according to the Cockcroft-Gault formula.
<br>
<br> - Total bilirubin <3 x the upper limit of normal (ULN), except for patients with
<br> known Gilbert's syndrome.
<br>
<br> - Aspartate aminotransaminase (AST) <3.0 x LSN.
<br>
<br> - Alanine aminotransaminase (ALT) <3.0 x ULN.
<br>
<br> Exclusion criteria:
<br>
<br> 1. Pregnant (positive ß-human chorionic gonadotropin test, ß-HCG) or lactating female at
<br> screening.
<br>
<br> 2. Patients with a history of retinopathy, sickle cell disease or trait, psoriasis,
<br> porphyria, history of splenectomy, mental illness or uncontrolled seizures disorder,
<br> known active tuberculosis or history of incompletely treated tuberculosis, patients on
<br> chronic immunosuppression for other medical conditions such as rheumatological
<br> disorders, inflammatory bowel disease, or in patients with organ transplants.
<br>
<br> 3. Patients admitted in ICU.
<br>
<br> 4. Taking medications which may lead to interactions with hydroxychloroquine, including
<br> penicillamine, telbivudine, botulinum toxin, fluconazole, digoxin, propafenone ,
<br> cimetidine, statins, warfarin, and cyclosporine within 2 weeks of dosing start, and
<br> during the duration of the study.
<br>
<br> 5. History of Glucose-6-phosphate dehydrogenase deficiency.
<br>
<br> 6. Pre-treatment corrected QT interval (QTc) =450 milliseconds.
<br>
<br> 7. Acute or chronic kidney disease (stage-4 or -5 renal impairment; eGFR<30 mL/min/1.73
<br> m2 or hemodialysis).
<br>
<br> 8. Liver Child-Pugh grade C.
<br>
<br> 9. Patients with Hypokalemia (<3.6 mg/dl), Hypocalcemia (<8.8 mg/dl), Hypomagnesemia
<br> (<1.7 mg/dl). Will be included after correction.
<br>
<br> 10. Need for mechanical ventilation.
<br>
<br> 11. History of hypersensitivity to hydroxychloroquine.
<br>
<br> 12. History of Chronic Hepatitis B or hepatitis C infections.
<br>
<br> 13. History of Human Immunodeficiency Virus (HIV) infection.
<br>
<br> 14. Concurrent serious illness including, but not limited to, any of the following:
<br>
<br> - Clinically significant cardiovascular disease (e.g., uncontrolled hypertension,
<br> myocardial infarction, or unstable angina).
<br>
<br> - New York Heart Association class II-IV congestive heart failure.
<br>
<br> - Serious cardiac arrhythmia requiring medication.
<br>
<br> - Peripheral vascular disease = grade 2 within the past year.
<br>
<br> - Psychiatric illness/social situation that would limit compliance with study
<br> requirements.
<br>
<br> - COPD, Lung cancer, and moderate to severe asthma.
<br>
<br> 15. Any other significant finding based on the judgment of the PI would increase the risk
<br> of having an adverse outcome from participating in this study.
<br>
<br> 16. Any other concomitant treatment based on the judgment of the PI would increase the
<br> risk of having an adverse outcome from participating in this study.
<br>
<br> 17. Is currently participating in or has participated in an interventional clinical trial
<br> with an investigational compound or device within 80 days of signing the informed
<br> consent/assent for this current trial.
<br> | | 2019 Novel Coronavirus | Drug: HCQ01;Drug: standard of care (SOC) for COVID-19 | Proportion of participants who improve by at least one level lower on the 11-point World Health Organization Ordinal Scale for Clinical Improvement (WHO-OSCI), where patients are scored on a scale of 0-10 with 0 being uninfected and 10 being dead . | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04815109 | 12 July 2021 | Prospective Electroencephalography Evaluation of Sedation in COVID-19 | Prospective Evaluation of Aggravated Sedation in COVID-19 ARDS Patients Using Electroencephalography | | Goethe University | 23/03/2021 | 20210323 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04815109 | Recruiting | No | 18 Years | 80 Years | All | April 1, 2021 | 50 | Observational | | | Germany | ; ; | Armin N Flinspach, M.D.;Armin N Flinspach, M.D.;Armin N Flinspach, MD | | ;arminflinspach@kgu.de; | ;0049-69/6301-5868; | Goethe-University Frankfurt; |
<br> Inclusion Criteria:
<br>
<br> Intubated ventilated patients with SARS-CoV-2 associated acute respiratory distress
<br> syndrome and sedation difficulty.
<br>
<br> Exclusion Criteria:
<br>
<br> Pre-existing severe cerebral brain damage and dysfunction. For example: previous medial
<br> infarction, cerebral hemorrhage, structural epilepsy.
<br> | | Conscious Sedation;Pathologic Processes;Electroencephalogram;Acute Respiratory Distress Syndrome;Corona Virus Infection | Other: Encephalography measurement | Processed encephalography measurement;Raw data encephalography measurement | | | | Yes | False | | |
| → | NCT04820803 | 12 July 2021 | Assessment of the Impact of Oral Intervention With Cetylpyridinium Chloride to Decrease SARS-CoV-2 Viral Load in Patients With COVID-19 | PILOT CLINICAL TRIAL TO ASSESS THE IMPACT OF ORAL INTERVENTION WITH CETIL PYRIDINIUM CHLORIDE TO REDUCE THE VIRAL LOAD OF SARS-CoV-2 | | Rosa Tarrago | 23/03/2021 | 20210323 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04820803 | Not recruiting | No | 18 Years | 80 Years | All | February 3, 2021 | 80 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | N/A | Spain | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Outpatients older than 18 years and younger than 80 years.
<br>
<br> - Patients with a medical indication for a diagnostic test for active infection to
<br> SARS-CoV-2
<br>
<br> - Patients who present mild symptoms typical of COVID-19 and who have less than three
<br> days of evolution
<br>
<br> - Patients who have cognitive and motor skills to perform mouthwash correctly.
<br>
<br> - Patients who understand and speak Spanish
<br>
<br> - Patients who freely give their consent to participate in the study, after a correct
<br> understanding of its objectives and procedures.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients with hospitalization criteria (moderate or severe symptoms)
<br>
<br> - Vulnerable populations such as pregnant, lactating,
<br>
<br> - Patients with recent medical diagnosis (= 1 month) of pneumonia
<br>
<br> - Patients with hyposialia
<br>
<br> - Patients with consumption of oral antiseptics (in the form of mouthwash containing
<br> CPC, povidone iodine rinses, alcohol mouthwash and essential oils) and toothpastes
<br> with CPC during the last month.
<br>
<br> - Patients with cognitive impairment
<br> | | COVID-19;SARS-CoV-2 Infection | Other: ORAL INTERVENTION WITH CETYLPYRIDINIUM CHLORIDE;Other: PLACEBO | SARS-CoV-2 Nucleocapsid protein in saliva by ELISA;Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples→Threshold cycle value of SARS-CoV-2 by Polymerase Chain Reaction (PCR) in saliva samples;SARS-CoV-2 Nucleocapsid protein in saliva by ELISA | | | | Yes | False | | |
| NCT04834908 | 12 July 2021 | Evaluation of Equine Antibody Treatment in Patients With COVID 19 Infection | A Prospective Randomized Multi-center Open Label Phase 1/2 Study to Evaluate the Safety and Efficacy of Equine COVID-19 Antiserum [F(ab')2](BSVEQAb) Plus Standard of Care in Comparison to Standard of Care Alone in COVID-19 RT-PCR Positive Patients | PROTECT | Bharat Serums and Vaccines Limited | 23/03/2021 | 20210323 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04834908 | Recruiting | No | 18 Years | 65 Years | All | June 2021 | 160 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1/Phase 2 | India | ; ; | Ramesh Jagannathan;Anirban Roy Chowdhury VP CR & PV Bharat serums and vaccines ltd;DrPiyush Chaudhari, DNB Internal medicine | | ;CR@bharatserums.com; | ;91-022-45043456; | Bharat Serums and Vaccines Ltd; |
<br> Inclusion Criteria:
<br>
<br> 1. Age Phase 1: = 18 years to = 55 years Phase 2: = 18 years to = 65 years
<br>
<br> 2. Are male or non-pregnant females who agree to contraceptive requirements.
<br>
<br> 3. Patients with RT-PCR confirmed COVID-19 in = 72 hours prior to randomization [Ct =
<br> 24].
<br>
<br> 4. Have SpO2<94% (range 90-93%) on room air.
<br>
<br> 5. Have one or more of the following- dyspnea, fever, cough, respiratory rate = 24 per
<br> minute and heart rate up to 120 per minute.
<br>
<br> 6. Patients who agree to participate in the study and follow all study related procedures
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Require mechanical ventilation
<br>
<br> 2. Have oxygen saturation less than or equal to 89 percent
<br>
<br> 3. Patients re-infected with SARS-CoV-2
<br>
<br> 4. Suspected or proven serious active bacterial fungal viral or other infection
<br>
<br> 5. Patients with positive skin test with IP
<br>
<br> 6. Patients with known equine allergies or past medical history of serum sickness
<br>
<br> 7. Patient who are HIV, HCV, HbsAg positive or immunocompromised
<br>
<br> 8. Patients with significant co-morbidities at screening
<br>
<br> 9. Moribund state
<br>
<br> 10. Pregnant or nursing women
<br>
<br> 11. Participating in other clinical trial
<br> | | SARS-CoV-2 Infection | Biological: Equine COVID-19 Antiserum;Drug: Standard of care | Phase 2 Patients turning COVID-19 negative (RT-PCR Negative);Phase 2 Patients turning COVID-19 negative (RT-PCR negative);Phase 1 Unexpected serious adverse events | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04951349 | 12 July 2021 | Safety and Efficacy of Intranasal Application of GX-03 as a Treatment and Prevention for COVID-19. | Phase 2b Clinical Trial to Evaluate the Tolerability and Efficacy in Reducing the Nasal Viral Load of SARS-CoV-2 of Benzalkonium Chloride 0.0065% (GX-03), in the Form of Nasal Ointment, in Patients Infected With COVID -19, and Evaluation of Its Tolerability in Health Care Providers, as a Preventive of Nasal Colonization, Complementary to Personal Protective Equipment | | Turn Therapeutics | 30/06/2021 | 20210630 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04951349 | Not recruiting | No | 18 Years | 65 Years | All | January 21, 2021 | 85 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | Panama | | Julio Sandoval, MD | | | | Medical Corps of Punta Pacifica Hospital |
<br> Inclusion Criteria:
<br>
<br> - 1. Patients aged 18-65 hospitalized with SARS-CoV-2, diagnosed by a positive nasal or
<br> nasopharyngeal swab
<br>
<br> 2. Men or women who are not pregnant, not breastfeeding, postmenopausal, naturally or
<br> surgically sterile, or who agree to use effective contraception during the course of
<br> the study. A postmenopausal patient is defined as at least 12 12 months of natural
<br> spontaneous amenorrhea or at least 6 weeks after surgical menopause (bilateral
<br> oophorectomy).
<br>
<br> 3. Women of childbearing age who use one of the following acceptable contraceptive
<br> methods can be included in the study:
<br>
<br> Surgical sterilization (hysterectomy and/or bilateral oophorectomy);
<br>
<br> Surgical sterilization (surgical bilateral tubal ligation at least 6 weeks prior to
<br> screening); Intrauterine device (IUD) placed at least 3 months prior to detection;
<br> Abstinence (not having heterosexual sex);
<br>
<br> Barrier method (condom or diaphragm) with spermicide for at least 14 days before selection
<br> and until completion of the study;
<br>
<br> Stable hormonal contraceptive for at least 3 months prior to selection and until completion
<br> of the study
<br>
<br> 4. Patients capable of understanding and providing signed informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. SARS-CoV-2 positive patients on a ventilator.
<br>
<br> 2. Patients with any open wounds, injuries, inflammation, erythema, or infection (other
<br> than COVID-19) affecting the nasal passages, nose, upper lip, and the area of skin
<br> around the nose, including herpes simplex lesions.
<br>
<br> 3. Patients with a history of abnormal bleeding, bruising, frequent nosebleeds, or those
<br> diagnosed with von Willebrand disease.
<br>
<br> 4. Patients with nasal polyps or significant anatomical nasal abnormalities.
<br>
<br> 5. Patients with a history of nasal surgery, including cauterization, in the last 6
<br> months.
<br>
<br> 6. Patients who currently have or have ever had a nose or septum piercing
<br>
<br> 7. Patients treated with antiviral medications in the past 7 days
<br>
<br> 8. Known allergy or history of significant adverse reactions to benzalkonium chloride or
<br> related compounds, or to any of the excipients.
<br>
<br> 9. Known or suspected pregnancy, pregnancy planned during the study period, or
<br> breastfeeding.
<br>
<br> 10. Clinically significant mental illness (to be determined by the investigator)
<br>
<br> 11. Recent history of (last 12 months) or strong potential for alcohol or substance abuse.
<br> Alcohol abuse will be defined as >14 drinks per week (1 drink = 12 oz of beer, 5.0 oz
<br> of wine, or 1.5 oz of distilled spirits)
<br>
<br> 12. Exposure to any agents being researched within 30 days prior to admission to the
<br> study.
<br>
<br> 13. Prior enrollment in this study
<br>
<br> 14. If the patient has a condition that the investigator believes would interfere with
<br> their ability to give informed consent or comply with study instructions, or that
<br> could confuse the interpretation of study results or put the patient at undue risk.
<br> | | Covid19 | Drug: GX-03;Drug: Petrolatum ointment | Reduction of 60% in viral load from baseline;Primary Safety analysis | | | | Yes | False | | |
| → | NCT04952337 | 12 July 2021 | Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19 (PROVID) - (PROVID-CAPNETZ) | Clinical, Molecular and Functional Biomarkers for PROgnosis, Pathomechanisms and Treatment Strategies of COVID-19 (PROVID) - (PROVID-CAPNETZ) | PROVID-CAPNETZ | Hannover Medical School | 27/10/2020 | 20201027 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04952337 | Recruiting | No | 18 Years | N/A | All | October 1, 2020 | 400 | Observational | | | Germany | ; ; | Grit Barten-Neiner;Grit Barten-Neiner;Bernhard Schaaf, PD Dr. | | ;office@capnetz.de;bernhard.schaaf@klinikumdo.de | ;+49-(0)511-532-4434;+49 (0)231 953-18100 | CAPNETZ Stiftung; |
<br> Inclusion Criteria:
<br>
<br> - Age = 18
<br>
<br> - Radiological proof of infiltrate (primarily chest x-ray or CT) with positive detection
<br> of SARS-CoV-2-virus or with no proven infiltrate with positive detection of
<br> SARS-CoV-2-virus
<br>
<br> - Informed consent signed
<br>
<br> Exclusion Criteria:
<br>
<br> - Newly diagnosed, active pulmonary tuberculosis within the last 2 months
<br>
<br> - Simultaneous participation in PROVID-PROGRESS or PROVID-CAPSyS cohort
<br>
<br> - Participation of the patient in PROVID-PROGRESS or PROVID-CAPSyS cohort at an earlier
<br> point in time
<br> | | COVID-19;Viral Pneumonia;Pneumonia Due to Streptococcus Pneumoniae;Bacterial Pneumonia;Pneumonia Due to H. Influenzae;Pneumonia, Organism Unspecified;Pneumonia in Diseases Classified Elsewhere;Pneumonia Due to Other Specified Infectious Organisms | | Determination of the severity of COVID-19;Determination of the course of COVID-19;Determination of the host- and virusdependent mechanisms associated with the clinical appearence of COVID-19→Determination of the host- and virusdependent mechanisms associated with the clinical appearence of COVID-19;Determination of the course of COVID-19;Determination of the severity of COVID-19 | | | | Yes | False | | |
| NCT04952519 | 12 July 2021 | Efficacy of Amantadine Treatment in COVID-19 Patients | Efficacy of Amantadine Treatment in COVID-19 Patients | TITAN | Noblewell | 28/06/2021 | 20210628 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04952519 | Recruiting | No | 18 Years | N/A | All | March 30, 2021 | 500 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | Poland | ; | Adam Barczyk, Prof.;Ewa Bachta | | ;ebachta@gcm.pl | ;+48323598918 | Leszek Giec Upper-Silesian Medical Centre of the Silesian Medical University in Katowice; |
<br> Inclusion Criteria:
<br>
<br> 1. Age of respondents - 18 years and older.
<br>
<br> 2. Confirmation of SARS-CoV-2 infection by PCR
<br>
<br> 3. Hospitalized patient with COVID-19, defined according to the following criteria (all
<br> of the following criteria must be present):
<br>
<br> 1. radiological (X-ray of klp or TK klp) features of pneumonia,
<br>
<br> 2. blood saturation (SaO2) measured at rest in the absence of oxygen <95%,
<br>
<br> 3. it is not necessary to apply on the day of patient enrollment: high-flow oxygen
<br> therapy or mechanical ventilation (non-invasive or invasive).
<br>
<br> 4. Time up to 7 days from the onset of COVID-19 symptoms. The onset of COVID-19 symptoms
<br> is the first day on which the first symptom typical for SARS-CoV-2 or COVID-19
<br> infection (in the opinion of the attending physician at the center) occurred, such as:
<br> fever, cough, shortness of breath, changes in taste or smell , muscle pain, chest
<br> pain, diarrhea, nausea, vomiting, sore throat, nasal congestion.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnancy or lactation
<br>
<br> 2. Presence of medical contraindications for inclusion in the examination in the opinion
<br> of the attending physician, in particular:
<br>
<br> a) comorbidities: i) clinically significant hepatic or renal insufficiency; ii)
<br> epilepsy or seizures (current or history of); iii) psychiatric or somatic diseases
<br> (present or in a history of agitation or confusion, delirium syndromes or exogenous
<br> psychoses); iv) cardiovascular diseases such as: severe congestive heart failure,
<br> cardiomyopathy, myocarditis, grade II-IV AV block, bradycardia, QT prolongation,
<br> perceived U waves or family history of congenital long QT syndrome, severe ventricular
<br> arrhythmias a history of heart (including torsade de pointes); v) diseases or
<br> conditions that significantly reduce the immunity of a patient (e.g. solid organ
<br> transplant, bone marrow transplantation (BMT), AIDS, immune biologics and / or
<br> high-dose steroids (> 20 mg prednisone daily).
<br>
<br> b) hypersensitivity to any component of the preparation, c) parallel use of drugs that
<br> prolong the QT interval, d) hypokalemia or hypomagnesaemia, e) untreated angle-closure
<br> glaucoma, f) use of amantadine currently or in the last 3 months prior to study
<br> inclusion; g) participation in another clinical program
<br> | | Patients With Moderate or Severe COVID-19 | Drug: Amantadine | Time to recovery | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| ACTRN12621000876897 | 12 July 2021 | The effect of enhanced messaging on COVID-19 testing intentions and behaviour. | Does a narrative-based animation or a fact-based animation increase COVID-19 testing intentions and behaviour in Australian citizens, compared to the current government information? | | Marie Bashir Institute at the University of Sydney | 07/07/2021 | 20210707 | ANZCTR | https://anzctr.org.au/ACTRN12621000876897.aspx | Not Recruiting | No | 18 Years | 39 Years | Both males and females | 20/08/2021 | 1500 | Interventional | Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel; | Not Applicable | Australia | | | | | | | Inclusion criteria: Live in Australia, aged 18-39, not University educated | Exclusion criteria: None | COVID-19; <br>COVID-19;Public Health - Health promotion/education;Infection - Other infectious diseases;Respiratory - Other respiratory disorders / diseases;Mental Health - Studies of normal psychology, cognitive function and behaviour | This study is a survey which will be conducted online through the Qualtrics platform. Participants will be recruited on social media (Facebook on Instagram) with an advertisement with the message ‘Over 18? We want to hear from you! Complete a short survey about COVID-19 and be in with the chance to win a $20 gift card’. If they click on the advert, participants will be directed to the landing page where they can read the PIS and Consent Form before accessing the survey.<br>The survey itself will be hosted on the survey platform Qualtrics, where it is possible to track adherence to the intervention, such that we can see at what point participants left the survey, if they did not complete it.<br>Participants will answer demographic questions and then will be randomised to receive one of two interventions or a control. This will take about 5 minutes to complete. Immediately following this, they will be asked our outcome questions, which will also take about 5 minutes to complete. Therefore the complete survey will take about 10 minutes in total.<br><br>Participants are told in the PIS that the results of the study will be posted on our website (https://sydneyhealthliteracylab.org.au).<br><br>INTERVENTIONS:<br>In a nationally representative survey our team ran in November 2020, we identified the most frequently identified reasons people had not to get a COVID-19 test, even if they had symptoms. Participants will be shown one of two animations which address the top barriers that were identified (I know what symptoms I have and don't believe they are COVID-19 ones e.g. hayfever/normal cold; I'm not sure my symptoms are bad enough; It is unlikely I have COVID-19 because there aren't many cases in my area; I’m not sure this symptom needs testing). In order to look at the bes | Intention to get tested for COVID-19:<br>Over the next 4 weeks, I plan to get tested if I have COVID-19 symptoms<br>[7 point scale from Strongly disagree to Strongly agree]<br>[Immediately post-intervention];Intention to get tested for COVID-19 as a hypothetical:<br>Imagine you woke up with a sore throat tomorrow. Would you get tested straight away?<br>[7 point scale from Strongly disagree to Strongly agree]<br>[Immediately post-intervention];Perceived intention for someone else to get tested for COVID-19:<br>Most people my age would get tested after seeing this information/video.<br>[7 point scale from Strongly disagree to Strongly agree]<br>[Immediately post-intervention] | | | | Yes | False | | |
| → | ISRCTN15351917 | 12 July 2021 | Effect of COVID-19 on diabetes in Black Asian and Minority Ethnic (BAME) patients | Impact of COVID-19 on staff and patients from the Black Asian and Minority Ethnic (BAME) community with diabetes | | Darent Valley Hospital | 01/07/2021 | 20210701 | ISRCTN | https://www.isrctn.com/ISRCTN15351917 | Recruiting | No | | | Both | 31/05/2021 | 100 | Observational | Single-centre longitudinal observational study (Other) | Not Applicable | United Kingdom | Rajdeep;Rajiv→Rajiv;Rajdeep | Heire;Singh |
Darent Valley Hospital
Darenth Wood Road
;
Darent Valley Hospital
Darenth Wood Road
| rajdeep.heire@nhs.net;rajiv.singh5@nhs.net | +44 (0)7947752111;+44 (0)7402592979 | ; | Inclusion criteria: <br> 1. 18 years and above<br> 2. Identifies as Black, Asian or Minority Ethnic (BAME)<br> 3. Diagnosed COVID-19 with viral PCR nasal swab in hospital or community<br> 4. Diagnosed type 1 or type 2 diabetes mellitus (T1DM or T2DM, according to WHO criteria) prior to or after COVID-19 diagnosis<br> 5. Able to provide informed consent and willing to participate in the study and follow the instructions<br> | Exclusion criteria: <br> 1. From any other demographic not in the BAME group<br> 2. Not confirmed COVID-19 with viral PCR nasal swab in hospital or community<br> 3. Not confirmed T1DM or T2DM according to WHO criteria<br> 4. Unwilling/unable to participate or comply with the protocol<br> | Impact of COVID-19 (SARS-CoV-2 infection) on diabetes in the BAME population <br>Nutritional, Metabolic, Endocrine <br>Diabetes mellitus | <br> Patients will be identified from the researchers' database (from Business Intelligence and Occupational Health) by applying inclusion and exclusion criteria. They will be invited to participate in the study via letter and will be mailed the Participant Information Sheet and Consent Form. If they consent they will be mailed a psychosocial questionnaire.<br><br> If they consent to participate, they will be invited for a Health Screening Assessment Visit. Participants will be instructed to attend Darent Valley Hospital Diabetes Centre, their GP surgery or a virtual telephone appointment if recent health records with pertinent data are available.<br> The screening visit will start with receiving informed consent from the participants, followed by:<br> 1. Physical parameters: height, weight and blood pressure measurements<br> 2. Blood tests: HbA1c, lipid profile, renal function<br> 3. Urine sample: urinary albumin creatinine ratio<br> 4. Patients can hand in their completed psychosocial questionnaire or complete the questionnaire<br> | Glycated haemoglobin (HbA1c) measured using blood test pre and post COVID-19 infection within 12 months | | 16/11/2021 | | No | False | | |
| ChiCTR2100048665 | 12 July 2021 | The impact of the third dose of inactivated vaccine against SARS-CoV-2 on immune response | The impact of the third dose of inactivated vaccine against SARS-CoV-2 on immune response | | First Affiliated Hospital, Sun Yat-sen University | 2021-07-12 | 20210712 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=129132 | Not Recruiting | No | 18 | 59 | Both | 2021-07-12 | morning group:33;afternoon group:30; | Interventional study | Non randomized control | 0 | China | Sui Peng | | 58 Second Zhongshan Road, Guangzhou, Guangdong, China | pengsui@vip.163.com | +86 13660652577 | the First Affiliated Hospital, Sun Yat-sen University | Inclusion criteria: 1. participants aged 18-59 years old;
<br>2. participants who had finished two dose of inactivated vaccine against SARS-CoV-2 ((BBIBP-CorV). | Exclusion criteria: 1. Those who are allergic to any component of the vaccine, and those who have history of severe allergic reactions to the vaccine, such as acute allergic reactions, urticaria, skin eczema, dyspnea, angioedema or abdominal pain;
<br>2. Those with fever or those who suffer from acute diseases or severe chronic diseases in the acute stage of onset;
<br>3. Pregnant women, lactating women, or having a pregnancy plan within 3 months;
<br>4. Patients with a history or family history of convulsions, epilepsy, encephalopathy or mental illness; Patients with uncontrolled epilepsy and other progressive neurological diseases; Patients with a history of Guillain-Barré syndrome;
<br>5. Those who have been diagnosed with congenital or acquired immunodeficiency HIV infected lymphoma leukemia or other autoimmune diseases;
<br>6. Those who have severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases and malignant tumors;
<br>7. A history of COVID-19 infection;
<br>8. Patients who take medicine affecting the immune function, such as immunosuppressant agents or immunopotentiators or glucocorticoids (>=10mg prednisone or other equivalent glucocorticoids) within one month before enrollment;
<br>9. Those who are considered unsuitable for vaccination by clinicians. | Coronavirus disease 2019 (COVID-19) | morning group:Vaccinated the third dose of COVID-19 inactivated vaccine in the morning;afternoon group:Vaccinated the third dose of COVID-19 inactivated vaccine in the afternoon; | SARS-CoV-2 RBD antibodies; | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-004206-59-ES | 12 July 2021 | Clinical trial, conducted at multiple trial sites, to test the safety and effectiveness of ATR-002 in hospitalized patients diagnosed with the lung disease COVID-19. | RESPIRE - A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19 - Safety and Efficacy of ATR-002 for Hospitalized Patients with COVID-19 | | Atriva Therapeutics GmbH | 05/07/2021 | 20210705 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004206-59 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 23/06/2021 | 220 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| India;Germany;Netherlands;South Africa;Bulgaria;Ukraine;Spain;Belgium | Clinical Development Solutions | | Eisenbahnstr. 1 | Team.CDS@atriva-therapeutics.com | +4970718597673 | Atriva Therapeutics GmbH | Inclusion criteria: <br>1. Capable of giving signed informed consent as described in Section 10.1.3 of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.<br>2. Study participant must be at least 18 years of age at the time of signing the ICF.<br>3. Study participants with a laboratory confirmed diagnosis of SARS-CoV-2 infection presenting as moderate -to-severe COVID-19 requiring hospitalization for COVID-19 (Clinical Severity Status [3] or [4]) and for medical reasons (see Section 8 of the protocol). Patients presenting to the hospital without a laboratory confirmed SARS-CoV-2 infection will be tested locally for SARS-CoV-2 during the screening period. <br>For sites in the EU: A CE certified SARS-CoV-2 PCR test kit is required to confirm infection. <br>For sites outside the EU: SARS-CoV-2 PCR test kits certified according to local regulations are required to confirm infection.<br>4. Body weight at least 50 kg and have a body mass index (BMI) = 18.0 kg/m2 and < 40.0 kg/m2.<br>5. Male or female.<br>6. A female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:<br>a. She is not a WOCBP as defined in Section 10.3.1 of the protocol.<br>b. Is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.3.2 of the protocol during the IMP period and for at least 4 weeks after the last dose of IMP. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of IMP.<br>7. A WOCBP must have a negative urine pregnancy test within 24 hours before the first dose of IMP, see Section 8.3.5 of the protocol.<br>a. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. In such cases, the participant must not be randomized if the serum pregnancy result is positive.<br>b. If a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. In such cases, the participant must not be randomized if the serum pregnancy result is positive.<br>c. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy.<br>8. A male study participant is eligible to participate if:<br>a. He is azoospermic<br>b. The partner is not a WOCBP as defined in Section 1.1.1 of the protocol.<br>c. The partner is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.3.2 of the protocol during the IMP period and for at least 90 days after the last dose of IMP. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of IMP.<br>d. He acknowledges that sperm donation is prohibited from the first dose of IMP until at least 90 days after the last dose of IMP.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 120<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 100<br> | Exclusion criteria: <br>1. Patient’s clinical condition is worsening rapidly.<br>2. Requiring ICU admission or ventilator support at screening or at randomization.<br>3. Suspected bacterial, fungal, viral, or other infection (besides COVID-19).<br>4. History of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. The medical monitor should be contacted by the investigator.<br>5. History of hypertension should have hypertension adequately controlled (BP < 140/90 mmHg) with appropriate anti-hypertensive treatment.<br>6. Clinically significant cardiac conduction abnormalities, including QTc prolongation of > 450 milliseconds.<br>7. Family history of Long QT Syndrome.<br>8. Heart failure class 3, or 4, as defined by the New York Heart Association (NYHA).<br>9. History of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening.<br>10. Patients with implanted defibrillators or permanent pacemakers.<br>11. Poorly controlled diabetes mellitus with an HbA1c > 7.5 %.<br>12. Renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome, or renal tubular acidosis.<br>13. Renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (eGFR, CKD-EPI) < 45 ml/min/1.73m2.<br>14. Chronic Obstructive Pulmonary Disease (COPD) GOLD C, or D, or hospitalization for exacerbation of COPD within 24 weeks prior to screening.<br>15. Other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure.<br>16. Asthma with a symptom control level of "uncontrolled", according to current GINA guidelines.<br>17. Currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation.<br>18. Known Hepatitis B or C infection.<br>19. Any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient.<br>20. Alanine transaminase (ALT) or aspartate transaminase (AST) >3.0 x ULN.<br>21. Total bilirubin >1.0 x ULN (=1.5 x ULN total bilirubin if known Gilbert’s syndrome).<br>22. Taking concomitant medication metabolized by CYP2C8 and/ or CYP2C9 and listed as “prohibited” in Section 10.5 of the protocol.<br>23. Taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for COVID-19. Any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. Inclusion needs to be approved by the investigator and medical monitor.<br>24. Taking medication that may seriously affect the immune system, e.g. chemotherapy, unless considered and documented as standard of care (e.g. corticosteroids) to treat COVID-19.<br>25. Currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization.<br>26. Known allergy or hypersensitivity to the IMP (including e | Adult hospitalized patients suffering from COVID-19. <br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: ATR-002<br>Product Code: ATR-002<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: ATR-002<br>CAS Number: 303175-44-2<br>Current Sponsor code: ATR-002<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: • Fulfillment of In-/exclusion criteria on day 1<br>• Target variable on day 15;Primary end point(s): • Population: All study participants fulfilling the inclusion and exclusion criteria<br>• Target variable: Clinical severity status on a 7-point ordinal scale at Day 15<br>• Estimator: Odds ratio of ATR-002 in addition to standard of care versus placebo in addition to standard of care with 95% confidence interval;Secondary Objective: • To show that ATR-002 in addition to standard of care shortens the time to clinically relevant improvement of COVID-19 for a hierarchically ordered sequence of time-to-event endpoints<br>• To show that the primary endpoint extended as AUC has a more favorable level under ATR-002 compared to placebo in addition to standard of care over the initial trial period of 30 days in adult hospitalized patients with COVID-19<br>• To explore whether survival time will be prolonged under ATR-002 compared to placebo in addition to standard of care during the initial 30 days of the trial period in adult hospitalized patients with COVID-19;Main Objective: • To demonstrate the efficacy of ATR-002 versus placebo in addition to standard of care based on the clinical severity status in adult hospitalized patients with COVID-19 | | | | No | False | | |
| → | EUCTR2021-000412-28-BE | 12 July 2021 | Sars-Cov2 vaccination in kidney transplant patient: a phase IV study of the immunogenicity and its determinants | COVID-19: Sars-Cov2 vaccination in kidney transplant patient: a phase IV study of the immunogenicity and its determinants - NEPHRO-VAC transplantation | | Hopital Erasme, Université Libre de Bruxelles | 04/02/2021 | 20210204 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000412-28 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 17/02/2021 | 80 | Interventional clinical trial of medicinal product | Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Belgium | data manager | | Route de Lennik 808 | delphine.kemlin@erasme.ulb.ac.be | Belgi025553334 | Hopital Erasme, Université Libre de Bruxelles | Inclusion criteria: <br>- Age of 18 years old or older<br>- Patients should met one of the cohort criteria<br>- life expectancy > 12 months<br>- Ability to provide informed consent<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 40<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 40<br> | Exclusion criteria: <br>- women who are pregnant or breastfeeding.<br><br> To reflect the real-world population of kidney transplant patients, the NEPHRO-VAC transplantation project is designed as inclusive as possible. Exclusion criteria are minimal and serve to exclude patients who are not evaluable, or in whom vaccination is considered not safe or not effective. Since baseline blood samples before vaccination will provide an individual reference level of antibody measures, potential bias can be anticipated for. As such, we can still evaluate the immune response induced by the vaccination only. Moreover, At baseline (ie before vaccination) blood samples will be taken. The existence of SARS-Cov-2 antibodies will be examined in the samples in retrospect. As such, based on the baseline antibody levels, we can divide the study population in a COVID+ and COVID- subgroup and perform subgroup analysis to evaluate the effect of this variable. We feel it is not feasible and necessary to exclude patients for the trial based on prevaccination SARS-CoV-2 antibody positivity. First of all the procedures in the study reflect the real life situation. Secondly, analyzing the study results the revaccination antibody levels will be a variable used in the analysis.<br><br><br> | Kidney transplant patients;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Trade Name: Comirnaty<br>Product Name: COMIRNATY<br>Pharmaceutical Form: Dispersion for injection<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br> | Main Objective: In the year 2020, the COVID19 pandemic caused by the Sars-Cov2 virus was responsible for a high mortality rate particularly in solid organ transplant recipients, and especially in kidney transplant patients who are the most frequent among organ solid transplant patients. The recent availability of anti-Sars-Cov2 vaccines could protect them from severe disease. However, it is widely accepted that vaccine responses are much weaker in this populations compared to healthy controls. <br>The primary objective is to assess the immune response to SARS-Cov2 vaccination (vaccine BNT162b2 Comirnaty®; Pfizer- BioNTech) in 80 kidney transplant recipients. ;Secondary Objective: - to assess the safety of immunization by the vaccine BNT162b2 (Comirnaty®; Pfizer- BioNTech)<br>- to study the duration of the immune response using serology assays performed on day 28 after the second dose as well as at 6 months after the first dose<br>- to assess in depth the humoral and cellular responses to the vaccine BNT162b2 (Comirnaty®; Pfizer- BioNTech), by measuring the Sars-Cov2 specific T and B cell responses and its evolution and longevity by sampling blood at different time point<br>- To compare the immunogenicity and safety of vaccination in patients previously infected or not by SARS-Cov2<br>- To assess the safety and efficacy of a third dose of vaccination by BNT162b2 (Comirnaty; Pfizer) in COVID19-free patients;Primary end point(s): ELISA RBD antibodies (IgG) 28 days after booster dose. For those with a previous COVID infection, the in house multiplex assay from Sciensano will be performed to discriminate between previous infection and vaccination;Timepoint(s) of evaluation of this end point: day 28 after the second vaccination→Timepoint(s) of evaluation of this end point: day 28 after the second vaccination;Primary end point(s): ELISA RBD antibodies (IgG) 28 days after booster dose. For those with a previous COVID infection, the in house multiplex assay from Sciensano will be performed to discriminate between previous infection and vaccination;Secondary Objective: - to assess the safety of immunization by the vaccine BNT162b2 (Comirnaty®; Pfizer- BioNTech)<br>- to study the duration of the immune response using serology assays performed on day 28 after the second dose as well as at 6 months after the first dose<br>- to assess in depth the humoral and cellular responses to the vaccine BNT162b2 (Comirnaty®; Pfizer- BioNTech), by measuring the Sars-Cov2 specific T and B cell responses and its evolution and longevity by sampling blood at different time point<br>- To compare the immunogenicity and safety of vaccination in patients previously infected or not by SARS-Cov2<br>- To assess the safety and efficacy of a third dose of vaccination by BNT162b2 (Comirnaty; Pfizer) in COVID19-free patients;Main Objective: In the year 2020, the COVID19 pandemic caused by the Sars-Cov2 virus was responsible for a high mortality rate particularly in solid organ transplant recipients, and especially in kidney transplant patients who are the most frequent among organ solid transplant patients. The recent availability of anti-Sars-Cov2 vaccines could protect them from severe disease. However, it is widely accepted that vaccine responses are much weaker in this populations compared to healthy controls. <br>The primary objective is to assess the immune response to SARS-Cov2 vaccination (vaccine BNT162b2 Comirnaty®; Pfizer- BioNTech) in 80 kidney transplant recipients. | | | | Yes | False | | |
| EUCTR2021-000461-33-BE | 12 July 2021 | Covid-19: Sars-Cov2 vaccination in hemodialysis patient: a phase IV study of the immunogenicity and its determinants | Covid-19: Sars-Cov2 vaccination in hemodialysis patient: a phase IV study of the immunogenicity and its determinants - NEPHRO-VAC hemodialysis | | Hopital Erasme, Université Libre de Bruxelles | 04/02/2021 | 20210204 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000461-33 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 17/02/2021 | 120 | Interventional clinical trial of medicinal product | Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Belgium | data manager | | Route de Lennik 808 | delphine.kemlin@erasme.ulb.ac.be | Belgi025553334 | Hopital Erasme, Université Libre de Bruxelles | Inclusion criteria: <br>- Age of 18 years old or older <br>- Patients should met one of the cohort criteria <br>- life expectancy > 12 months <br>- Ability to provide informed consent <br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 60<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 60<br> | Exclusion criteria: <br>- women who are pregnant or breastfeeding <br> <br>To reflect the real-world population of hemodialysis patients, the NEPHRO-VAChemodialysis project is designed as inclusive as possible. Exclusion criteria are minimal and serve to exclude patients who are not evaluable, or in whom vaccination is considered not safe or not effective. <br>Since baseline blood samples before vaccination will provide an individual reference level of antibody measures, potential bias can be anticipated for. As such, we can still evaluate the immune response induced by the vaccination only. Moreover, At baseline (ie before vaccination) blood samples will be taken. The existence of SARS-Cov-2 antibodies will be examined in the samples in retrospect. As such, based on the baseline antibody levels, we can divide the study population in a COVID+ and COVID- subgroup and perform subgroup analysis to evaluate the effect of this variable. We feel it is not feasible and necessary to exclude patients for the trial based on prevaccination SARS-CoV-2 antibody positivity. First of all the procedures in the study reflect the real life situation. Secondly, analyzing the study results the revaccination antibody levels will be a variable used in the analysis.<br><br> | Chronic hemodialysis patients;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Trade Name: Comirnaty<br>Product Name: COMIRNATY<br>Pharmaceutical Form: Dispersion for injection<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br> | Timepoint(s) of evaluation of this end point: day 28 after second vaccination;Primary end point(s): ELISA RBD antibodies (IgG) 28 days after booster dose. For those with a previous COVID infection, the in house multiplex assay from Sciensano will be performed to discriminate between previous infection and vaccination;Secondary Objective: - to assess the safety of immunization by the vaccine BNT162b2 (Comirnaty®; Pfizer- BioNTech)<br>- to study the duration of the immune response using serology assays performed on day 28 after the second dose and up to one year after the first dose<br>- to assess in depth the humoral and cellular responses to the vaccine BNT162b2 (Comirnaty®; Pfizer- BioNTech), by measuring the Sars-Cov2 specific T and B cell responses and its evolution and longevity by sampling blood at different time point <br>- To compare the immunogenicity and safety of vaccination in patients previously infected or not by SARS-Cov2<br>- To assess the safety and the efficacy of a third dose of vaccination in COVID19-free patients;Main Objective: In the year 2020, the COVID19 pandemic caused by the Sars-Cov2 virus was responsible for a high mortality rate particularly in hemodialysis patients. The recent availability of anti-Sars-Cov2 vaccines could protect them from severe disease. However, it is widely accepted that vaccine responses are much weaker in this populations compared to healthy controls. The primary objective is to assess the immune response to SARS-Cov2 vaccination (vaccine BNT162b2 Comirnaty®; Pfizer- BioNTech) in 120 hemodialysis patients. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04556318 | 21 July 2021 | Identification of Differences in Breath Components Detected With IMS in Patients Tested on SARS-CoV-2 (COVID-19) | Study to Identify Differences of Exhaled Breath Components Using Ion Mobility Spectrometry (IMS) in Patients Tested Positive or Negative on SARS-CoV-2 | | B. Braun Melsungen AG | 18/09/2020 | 20200918 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04556318 | Not recruiting | No | 18 Years | N/A | All | September 23, 2020 | 396 | Observational | | | Germany | | Christoph Spinner, PD Dr. | | | | Technical University of Munich, Klinikum rechts der Isar |
<br> Inclusion Criteria:
<br>
<br> - SARS-CoV-2-Polymerase chain reaction (PCR) test result is available
<br>
<br> - Signs or symptoms of any respiratory system infection or Signs or symptoms indicating
<br> SARS-CoV-2 infection or Radiological findings suggesting viral lung infection
<br>
<br> - Breath test (Study intervention) must be performed within a 2 day time period after
<br> latest SARS-CoV-2 PCR
<br>
<br> Exclusion Criteria:
<br>
<br> - History of SARS-CoV-2 outside the current respiratory episode (known from medical
<br> history)
<br>
<br> - Participation in another clinical study prior to breath analysis which could influence
<br> the result of the breath analysis
<br> | | Covid19 | Device: Ion Mobility Spectrometry (IMS) | SARS-CoV-2 related volatile organic compounds (VOC) | | | | Yes | False | | |
| → | NCT04559542 | 21 July 2021 | Body Weight Regulation, Disordered Eating Behaviour, and Experiences of Sexual Harassment in Female Martial Art Athletes | Management of Body Weight Regulation, Symptoms of Low Energy Availability, Body Acceptance, Eating Disorders, and Sexual Harassment Among Female Martial Art Athletes, and Impact of COVID-19 on Training and Sport Participation | FMAB | Norwegian School of Sport Sciences | 25/08/2020 | 20200825 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04559542 | Not recruiting | No | 16 Years | 40 Years | Female | September 10, 2020 | 33 | Observational | | | Norway | | Jorunn Sundgot-Borgen, PhD | | | | Norwegian School of Sport Sciences |
<br> Inclusion Criteria:
<br>
<br> - martial art athlete
<br>
<br> - living and training in Oslo-area (main capital) in Norway
<br>
<br> Exclusion Criteria:
<br>
<br> - not matching sex, age or sport criteria
<br> | | Body Weight Changes;Eating Disorder Symptom;Sexual Harassment;Covid19;RED S | | Body appreciation scale (BAS-2);Body Weight regulation strategies, selfreported;Eating disorder examination questionnaire (EDE-q);Low energy availability for females questionnaire (LEAF-Q)→Low energy availability for females questionnaire (LEAF-Q);Eating disorder examination questionnaire (EDE-q);Body Weight regulation strategies, selfreported;Body appreciation scale (BAS-2) | | | | Yes | False | | |
| NCT04563065 | 21 July 2021 | Active Pregnancy Against COVID-19 | Active Pregnancy, Prevention Against the Effects of COVID-19 | ACPREGCOV | Universidad Politecnica de Madrid | 19/09/2020 | 20200919 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04563065 | Recruiting | No | 18 Years | 50 Years | Female | August 1, 2020 | 280 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). | N/A | Spain | ; | Rubén Barakat, Dr;Cristina Silva-Jose, Msc | | ;cristina.silva.jose@upm.es | ;+34662556019 | Universidad Politécnica de Madrid (UPM); |
<br> Inclusion Criteria:
<br>
<br> - Pregnant women fulfilling the following criteria: >18 years old, singleton pregnancies
<br> and planning management and delivery at the research hospitals and also do not
<br> participate in any other program of supervised physical exercise.
<br>
<br> Exclusion Criteria:
<br>
<br> - Women with absolute contraindications. Women with relative contraindications need
<br> permission from obstetric care provider prior to participation(1,2):
<br>
<br> Absolute contraindications to exercise:
<br>
<br> - Ruptured membranes.
<br>
<br> - Premature labour.
<br>
<br> - Unexplained persistent vaginal bleeding.
<br>
<br> - Placenta praevia after 28 weeks' gestation.
<br>
<br> - Pre-eclampsia.
<br>
<br> - Incompetent cervix.
<br>
<br> - Intrauterine growth restriction.
<br>
<br> - High-order multiple pregnancy (eg, triplets).
<br>
<br> - Uncontrolled type I diabetes.
<br>
<br> - Uncontrolled hypertension.
<br>
<br> - Uncontrolled thyroid disease.
<br>
<br> - Other serious cardiovascular, respiratory or systemic disorder.
<br>
<br> Relative contraindications to exercise:
<br>
<br> - Recurrent pregnancy loss.
<br>
<br> - Gestational hypertension.
<br>
<br> - A history of spontaneous preterm birth.
<br>
<br> - Mild/moderate cardiovascular or respiratory disease.
<br>
<br> - Symptomatic anaemia.
<br>
<br> - Malnutrition.
<br>
<br> - Eating disorder.
<br>
<br> - Twin pregnancy after the 28th week.
<br>
<br> - Other significant medical conditions.
<br>
<br> References:
<br>
<br> 1. Mottola, M. F., Davenport, M. H., Ruchat, S. M., Davies, G. A., Poitras, V. J., Gray,
<br> C. E., … Zehr, L. 2019 Canadian guideline for physical activity throughout pregnancy.
<br> British Journal of Sports Medicine, 2018; 52(21), 1339-1346.
<br> https://doi.org/10.1136/bjsports-2018-100056.
<br>
<br> 2. Barakat R, Díaz-Blanco A, Franco E, Rollán-Malmierca A, Brik M, Vargas M, et al. Guías
<br> clínicas para el ejercicio físico durante el embarazo/Clinical guidelines for physical
<br> exercise during pregnancy. Prog Obstet Ginecol 2019;62(5):464-471. DOI:
<br> 10.20960/j.pog.00231.
<br> | | Pregnancy Complications;Pregnancy, High Risk;Pregnancy Induced Hypertension;Newborn Morbidity;Fetal Growth Retardation;Fetus Disorder;Weight Gain, Maternal;Maternal-Fetal Relations | Other: Exercise program;Other: Healthy lifestyle advise | psychomotor behavior of the child;mental assessment of the child (depression questionnaire adapted to childhood);child's height;child's weight;birthweight;duration of labor;type of delivery (Vaginal, instrumental or cesarean);gestational age;Behavior of Fetal Heart Rate;depression scale (CES-D);State-Trait Anxiety Inventory (STAI);Urinary Incontinence Questionnaire (ICIQ-SF);OGTT-O'Sullivan test;blood pressure;Maternal weight gain | | | | Yes | False | | |
| NCT04579393 | 21 July 2021 | Fostamatinib for Hospitalized Adults With COVID-19 | A Phase II Study Evaluating Fostamatinib for Hospitalized Adults With COVID-19 | | National Heart, Lung, and Blood Institute (NHLBI) | 06/10/2020 | 20201006 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04579393 | Not recruiting | No | 18 Years | N/A | All | October 8, 2020 | 62 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | United States | | Jeffrey R Strich, M.D. | | | | National Institutes of Health Clinical Center (CC) |
<br> - INCLUSION CRITERIA:
<br>
<br> 1. Patient must be hospitalized, or had their inpatient stay extended, for COVID-19.
<br>
<br> 2. Age >=18 years
<br>
<br> 3. Subject (or legally authorized representative) provides informed consent prior to
<br> initiation of any study procedures.
<br>
<br> 4. Subject (or legally authorized representative) understands and agrees to comply
<br> with planned study procedures.
<br>
<br> 5. Females of childbearing potential must agree to be abstinent or use a medical
<br> acceptable form of contraception from the time of enrollment through 30 days
<br> after last day of study drug
<br>
<br> 6. Laboratory confirmed SARS-CoV-2 RT-PCR test within 7 days of enrollment
<br>
<br> 7. Illness of any duration with SpO2 of less than 94% on room air requiring
<br> supplemental oxygen via nasal canula or non-invasive mechanical ventilation, or
<br> mechanical ventilation or ECMO (5 to 7 on the 8-point scale)
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> 1. ALT or AST > 5 times the upper limit of normal (ULN) or ALT or AST >= 3 x ULN and
<br> total bilirubin > 2 x ULN.
<br>
<br> 2. Estimated glomerular filtration rate (eGFR) <30ml/min
<br>
<br> 3. Pregnancy or breast feeding
<br>
<br> 4. Anticipated discharge in the next 72 hours
<br>
<br> 5. Allergy to study medication
<br>
<br> 6. Uncontrolled hypertension (systolic blood pressure >160mmHg or diastolic blood
<br> pressure >100mmHg)
<br>
<br> 7. Shock or hypotension at the time of enrollment
<br>
<br> 8. Neutrophil count <1000/microliter
<br>
<br> 9. Concern for bacterial or fungal sepsis
<br>
<br> 10. Received immunomodulatory treatment within 30 days prior to enrollment e.g., Bruton's
<br> tyrosine kinase/phosphoinositide 3 kinase/Janus kinase inhibitor or cytokine-targeting
<br> biologic therapy (anti-TNF, IL-6)
<br>
<br> 11. Received a live vaccine the last 4 weeks
<br>
<br> 12. Those who were cognitively impaired or mentally disabled prior to COVID diagnosis
<br>
<br> 13. Participation in another clinical trial for the treatment of COVID-19.
<br> | | Coronavirus Disease 2019 | Drug: Placebo;Drug: fostamatinib | Cumulative Incidence of SAEs | | | | Yes | False | | |
| → | NCT04582903 | 21 July 2021 | Send-In Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence | Send-in Sample Collection for Comprehensive Analyses of Innate and Adaptive Immune Responses During Acute COVID-19 and Convalescence | | National Institute of Allergy and Infectious Diseases (NIAID) | 09/10/2020 | 20201009 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04582903 | Recruiting | No | N/A | 99 Years | All | October 13, 2020 | 500 | Observational | | | United States | ; ; | Helen C Su, M.D.;Margaret A Abaandou;Helen Su, M.D. Ph. D | | ;margaret.abaandou@nih.gov;hsu@niaid.nih.gov | ;(301) 761-7627;301-451-8783 | National Institute of Allergy and Infectious Diseases (NIAID); |
<br> - INCLUSION CRITERIA:
<br>
<br> Participants enrolled onto this protocol must meet all of the following criteria:
<br>
<br> 1. Aged 0-99 years (including viable neonates).
<br>
<br> 2. Meets one of the following criteria:
<br>
<br> 1. Patient with a known or suspected diagnosis of SARS-CoV-2 infection (past or
<br> current), typically but not always supported by a positive PCR test for viral
<br> RNA;
<br>
<br> 2. Individual who has remained uninfected with negative SARS-CoV-2 serologies
<br> despite heavy or extensive COVID-19 exposure in the workplace or home
<br> environment; or
<br>
<br> 3. Biological relative of a participant being studied under this protocol. Relatives
<br> may be biological mother, father, siblings, children, grandparents, aunts,
<br> uncles, or first cousins.
<br>
<br> 3. For individuals considered for enrollment as uninfected individuals and biological
<br> relatives, able to provide informed consent.
<br>
<br> 4. Willing to allow genetic testing.
<br>
<br> 5. Willing to allow storage of samples and data for future research.
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> Individuals meeting any of the following criteria will be excluded from study
<br> participation:
<br>
<br> 1. Any condition that, in the opinion of the investigator, contraindicates participation in
<br> this study.
<br>
<br> Since patients can be concurrently infected with multiple respiratory viruses, positive
<br> testing for other viruses such as rhinovirus, influenza virus, etc., does not exclude an
<br> individual from study participation where there remains a high clinical suspicion of
<br> COVID-19 infection despite negative testing for SARS-CoV-2.
<br>
<br> Co-enrollment guidelines: Participants may be co-enrolled in other studies; however, study
<br> staff should be notified of co-enrollment.
<br> | | COVID-19 Infection | | Characterization of the dynamic changes of innate and adaptive immune responses during SARS CoV 2 infection and convalescence.;Identification of genetic variants that are associated with either severe/lethal COVID-19 or resistance to SARS CoV 2 infection.;Measurement of proinflammatory/anti inflammatory cytokines produced during SARS CoV 2 infection and convalescence, including the IFN signature response.;Survey of other potential blood proteomic biomarkers of disease.;Characterization of serological responses against SARS CoV 2, other viruses or microbiota, and host antigens.;Characterization of intrapatient SARS-CoV-2 genetic variation andevolution during infection and convalescence.→Characterization of intrapatient SARS-CoV-2 genetic variation andevolution during infection and convalescence.;Characterization of serological responses against SARS CoV 2, other viruses or microbiota, and host antigens.;Survey of other potential blood proteomic biomarkers of disease.;Measurement of proinflammatory/anti inflammatory cytokines produced during SARS CoV 2 infection and convalescence, including the IFN signature response.;Identification of genetic variants that are associated with either severe/lethal COVID-19 or resistance to SARS CoV 2 infection.;Characterization of the dynamic changes of innate and adaptive immune responses during SARS CoV 2 infection and convalescence. | | | | Yes | False | | |
| NCT04640610 | 21 July 2021 | Angiotensin-converting Enzyme 2 (ACE2) Expression in Tonsils and Adenoids | Study of the Expression of Angiotensin-converting Enzyme 2 (ACE2), a Cell Membrane Receptor for SARS-CoV-2 and the TMPRSS2 Serine Protease in Tonsils and Adenoids of Children and Adults | ACE2-AVG | Assistance Publique - Hôpitaux de Paris | 19/11/2020 | 20201119 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04640610 | Not recruiting | No | N/A | N/A | All | June 30, 2021 | 0 | Observational | | | France | ; | Romain Luscan, MD;Pierre-Louis Tharaux, MD, PhD | | ; | ; | Assistance Publique - Hôpitaux de Paris;Institut National de la Santé Et de la Recherche Médicale, France |
<br> Inclusion Criteria:
<br>
<br> - Children and adults, without SARS-CoV-2 infection, in whom an adenoidectomy and/or
<br> tonsillectomy is performed for their care in the hospitals of Assistance
<br> Publique-Hôpitaux de Paris participating in the study.
<br>
<br> - Holders of parental authority of minor patients and adult patients not opposed to
<br> participation in the study.
<br>
<br> Exclusion Criteria:
<br>
<br> - N/A
<br> | | Adenoidectomy;Tonsillectomy | Other: Storage of operating waste | Expression of ACE 2 receptor and TMPRSS2 serine protease | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04756830 | 21 July 2021 | A Study to Assess the Safety and Immunogenicity of the Coronavac Vaccine Against COVID-19 | An Open-label Uncontrolled Study to Assess the Safety and Immunogenicity of the Inactivated Adsorbed Vaccine Against COVID-19 (Coronavac) in Individuals Over 18 Years of Age During 24 Months of Follow-up | | D'Or Institute for Research and Education | 15/02/2021 | 20210215 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04756830 | Not recruiting | No | 18 Years | N/A | All | February 19, 2021 | 1200 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 4 | Brazil | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Adults 18 years of age or older;
<br>
<br> - Agree with study procedures after reading and signing the Informed Consent Form
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnancy (confirmed by positive ß-hCG test), breastfeeding and / or expressing
<br> intention to have sexual practices with reproductive potential without using
<br> contraceptive methods in the three months following vaccination
<br>
<br> - Evidence of uncontrolled neurological, cardiac, pulmonary, hepatic or renal disease,
<br> according to anamnesis or physical examination. Significant changes in treatment or
<br> hospitalizations due to worsening of the condition in the last three months are
<br> indicators of uncontrolled disease;
<br>
<br> - Diseases with impaired immune system including: neoplasms (except basal cell
<br> carcinoma), congenital or acquired immunodeficiencies and autoimmune diseases not
<br> controlled according to anamnesis or physical examination. Significant changes in
<br> treatment or hospitalizations due to worsening of the condition in the last three
<br> months are indicators of uncontrolled disease;
<br>
<br> - Behavioral, cognitive or psychiatric illness that, in the opinion of the principal
<br> investigator or his medical representative, affects the participant's ability to
<br> understand and collaborate with the requirements of the study protocol
<br>
<br> - Any alcohol or drug abuse in the last 12 months prior to inclusion in the study that
<br> has caused medical, professional or family problems, as indicated by clinical history;
<br>
<br> - History of severe allergic reaction or anaphylaxis to the vaccine or components of the
<br> study vaccine;
<br>
<br> - History of asplenia;
<br>
<br> - Participation in another clinical trial with product administration under
<br> investigation during the six months prior to its inclusion in the study or scheduled
<br> participation in another clinical trial in the two years following inclusion;
<br>
<br> - Previous participation in a COVID-19 vaccine evaluation study or previous exposure to
<br> a COVID-19 vaccine;
<br>
<br> - Use of immunosuppressive therapies six months prior to inclusion in the study or its
<br> scheduled use within two years of inclusion. Immunosuppressive therapies will be
<br> considered: antineoplastic chemotherapy, radiation therapy, immunosuppressants to
<br> induce tolerance to transplants, among others.
<br>
<br> - Have received an immunosuppressive dose of corticosteroids in the last three months
<br> prior to inclusion in the study or scheduled administration of an immunosuppressive
<br> dose of corticosteroids for the three months following inclusion in the study. The
<br> dose of corticosteroids considered immunosuppressive is equivalent to prednisone at a
<br> dose of 20 mg / day for adults, for more than a week. The continuous use of topical or
<br> nasal corticosteroids is not considered immunosuppressive;
<br>
<br> - Have received blood products (transfusions or immunoglobulins) in the last three
<br> months before inclusion in the study, or scheduled administration of blood products or
<br> immunoglobulin in the two years following inclusion in the study;
<br>
<br> - Suspected or confirmed fever within 72 hours prior to vaccination or axillary
<br> temperature greater than 37.8 ° C * on the day of vaccination (inclusion may be
<br> postponed until the participant completes 72 hours without fever);
<br>
<br> - Possible or confirmed case of COVID-19 on the day of vaccination (vaccination can be
<br> postponed until the participant completes 72 hours without symptoms or the diagnosis
<br> is ruled out);
<br>
<br> - Have received vaccine with live attenuated virus in the last 28 days or inactivated
<br> vaccine in the last 14 days prior to their inclusion in the study, or have
<br> immunization scheduled for the first 28 days after their inclusion in the study;
<br>
<br> - History of bleeding disorders (for example, deficiency of clotting factors,
<br> coagulopathy, platelet dysfunction), or previous history of bleeding or significant
<br> bruising after IM injection or venipuncture.
<br>
<br> - Any other condition that, in the opinion of the principal investigator or his medical
<br> representative, could jeopardize the safety or rights of a potential participant or
<br> that would prevent him from complying with this protocol.
<br> | | COVID-19 | Biological: Adsorbed COVID-19 (inactivated) Vaccine | Seroconversion rates;Frequency of local and systemic adverse reactions in the first 7 days after immunization | | | | Yes | False | | |
| → | NCT04760418 | 21 July 2021 | Trauma and Trauma-Focused Therapy in the University of Kentucky SMART Clinic | Evaluating the Impact of Trauma, Trauma-Focused Therapy Services, and COVID-19 Among Patients in the University of Kentucky SMART Clinic | | Christal L Badour | 10/02/2021 | 20210210 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04760418 | Recruiting | No | 18 Years | N/A | All | May 26, 2021 | 6 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United States | ; ; | Christal Badour, PhD;Christal L Badour, PhD;Christal Badour, PhD | | ;Christal.badour@uky.edu;christal.badour@uky.edu | ;859-323-3817;859-323-3817 | University of Kentucky; |
<br> Inclusion Criteria:
<br>
<br> - Currently a patient in the University of Kentucky Department of Psychiatry Supportive
<br> Medication and Recovery Treatment (SMART) Program for at least 4 weeks
<br>
<br> - Current diagnosis PTSD
<br>
<br> Exclusion Criteria:
<br>
<br> - History of schizophrenia or other psychotic disorder
<br>
<br> - Current mania
<br> | | PTSD;Opioid-use Disorder;Substance Use Disorders | Behavioral: Concurrent Treatment of PTSD and Substance Use Disorders Using Prolonged Exposure (COPE) | Recovery Update Form;PTSD Checklist for DSM-5 (PCL-5)→PTSD Checklist for DSM-5 (PCL-5);Recovery Update Form | | | | Yes | False | | |
| NCT04762173 | 21 July 2021 | Self-Help for Stress Related to COVID-19 | Self-Help for Stress Related to COVID-19 | | Penn State University | 15/02/2021 | 20210215 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04762173 | Not recruiting | No | 18 Years | N/A | All | November 6, 2020 | 585 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United States | | Gavin N Rackoff, MS | | | | The Pennsylvania State University |
<br> Inclusion Criteria:
<br>
<br> - Moderate or higher stress as assessed using Stress subscale of the Depression Anxiety
<br> Stress Scales-Short Form
<br>
<br> - Current student at a college or university in the United States
<br>
<br> - Able to provide consent
<br>
<br> - Proficient in English
<br>
<br> Exclusion Criteria:
<br>
<br> - Below age 18
<br>
<br> - Failure to meet any of above inclusion criteria
<br>
<br> - Current participant in separate randomized controlled trial being conducted by this
<br> research group examining efficacy of SilverCloud Health interventions
<br> | | Stress | Device: Online self-help intervention | Change in stress | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04959760 | 26 July 2021 | BinaxNow COVID-19 IgG Rapid Test Device and Antibody Self Test | Clinical Evaluation of the BinaxNOW™ COVID-19 IgG Rapid Test Device and the BinaxNOW™ COVID-19 Antibody Self Test Clinical Study Protocol | | Abbott Rapid Diagnostics Jena GmbH | 01/07/2021 | 20210701 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04959760 | Recruiting | No | 18 Years | N/A | All | June 3, 2021 | 185 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | United States | ; | Simon Kordowich;Simon Kordowich | | ;simon.kordowich@abbott.com | ;+49 162-136-8985 | Abbott; |
<br> Inclusion Criteria:
<br>
<br> 1. Participant is 18 years of age or older.
<br>
<br> 2. Evaluable individuals with a prior confirmed SARS-CoV-2 infection with prior COVID-19
<br> symptoms with symptoms onset > 14 days prior to the study, or symptoms onset 8-14 days
<br> prior to the study, or symptoms onset 0-7 days prior to study.OR
<br>
<br> Evaluable individuals confirmed negative by SARS-CoV-2 RT-PCR using a sample obtained
<br> within 7 days prior to or on the day of the study.
<br>
<br> 3. Participant agrees to complete all aspects of the study.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Participant has already participated in this study on a previous occasion.
<br>
<br> 2. Participant is enrolled in a study to evaluate a new drug.
<br>
<br> 3. Participant has a visual impairment that cannot be restored using glasses or contact
<br> lenses.
<br>
<br> 4. Participant is unable or unwilling to provide informed consent.
<br>
<br> 5. Participant is a vulnerable person as deemed unfit for the study by the Principal
<br> Investigator.
<br>
<br> 6. Participant has a condition deemed unfit to safely perform the test by the
<br> investigator.
<br>
<br> 7. Participant is a practising health-care professional or laboratory scientist /
<br> technician.
<br> | | COVID-19 Respiratory Infection | Diagnostic Test: The BinaxNOW™ Antibody Tests measure IgG antibodies against SARS-CoV-2. | Clinical performance of the BinaxNOW™ COVID-19 IgG Rapid Test;Clinical performance of the BinaxNOW™ COVID-19 Antibody Self-Test | | | | Yes | False | | |
| → | NCT04961333 | 26 July 2021 | Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome | Internet-based Multidisciplinary Rehabilitation for Longterm COVID-19 Syndrome | COVID-19 | Danderyd Hospital | 07/05/2021 | 20210507 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04961333 | Recruiting | No | 18 Years | 67 Years | All | April 23, 2021 | 200 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Participant). | N/A | Sweden | ; | Indre Bileviciute-Ljungar, Associated professor;Indre Bileviciute-Ljungar, Associated professor | | indre.ljungar@ki.se;indre.ljungar@ki.se | +46858703158;+46858703158 | |
<br> Inclusion Criteria:
<br>
<br> - confirmed COVID-19 infection
<br>
<br> - post-infection symptoms lasting longer than 3-6 months
<br>
<br> - clinically stable persons regarding symtoms or other co-morbidities
<br>
<br> - ability to participate in internet-based rehabilitation in group in Swedish.
<br>
<br> Exclusion Criteria:
<br>
<br> - uncertainty regarding covid-19 infection or co-morbidities started or exacerbated
<br> during the same time
<br>
<br> - alcohol and drug abuse
<br>
<br> - untreated psychiatric and somatic co-morbidities
<br>
<br> - undergoing medical or psychotherapeutic treatment or rehabilitation which can interact
<br> with rehabilitation outcomes.
<br> | | Long COVID-19 | Behavioral: Multidisciplinary Rehabilitation | Changes in heart rate variability during physical tests;Change in health-related quality of life measured by Short Form-36→Change in health-related quality of life measured by Short Form-36;Changes in heart rate variability during physical tests | | | | Yes | False | | |
| NCT04961385 | 26 July 2021 | Immunogenicity of the ChAdox1 n CoV-19 Vaccine With 12-dose Vial | Immunogenicity of the ChAdox1 n CoV-19 Vaccine Against SARS-CoV-2 With 12-dose Vials: an Interim Analysis | | Bangkok Metropolitan Administration Medical College and Vajira Hospital | 25/06/2021 | 20210625 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04961385 | Not recruiting | No | 18 Years | N/A | All | April 1, 2021 | 60 | Observational | | | Thailand | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Participants were eligible if they were more than 18 years old.
<br>
<br> Exclusion Criteria:
<br>
<br> - Allergic to components of vaccine
<br>
<br> - Risk of COVID-19 infection in the previous 14 days before enrollment i.e close contact
<br> with index cases or history of fever with upper respiratory tract infection.
<br> | | Covid19;Vaccine;Immunogenicity | Biological: Immunogenicity after first dose of participants who received first dose of ChAdox-1 n COV-19 vaccine | Antispike RBD IgG level;Antispike RBD IgG level;Antispike RBD IgG level;Neutralizing antibody;Neutralizing antibody;Neutralizing antibody | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-004206-59-NL | 26 July 2021 | Clinical trial, conducted at multiple trial sites, to test the safety and effectiveness of ATR-002 in hospitalized patients diagnosed with the lung disease COVID-19. | RESPIRE - A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19 - Safety and Efficacy of ATR-002 for Hospitalized Patients with COVID-19 | | Atriva Therapeutics GmbH | 24/03/2021 | 20210324 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004206-59 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 28/05/2021 | 220 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| India;Netherlands;Germany;South Africa;Belgium;Spain | Clinical Development Solutions | | Eisenbahnstr. 1 | Team.CDS@atriva-therapeutics.com | +4970718597673 | Atriva Therapeutics GmbH | Inclusion criteria: <br>1. Capable of giving signed informed consent as described in Section 10.1.3 of the protocol, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.<br>2. Study participant must be at least 18 years of age at the time of signing the ICF.<br>3. Study participants with a laboratory confirmed diagnosis of SARS-CoV-2 infection presenting as moderate -to-severe COVID-19 requiring hospitalization for COVID-19 (Clinical Severity Status [3] or [4]) and for medical reasons (see Section 8 of the protocol). Patients presenting to the hospital without a laboratory confirmed SARS-CoV-2 infection will be tested locally for SARS-CoV-2 during the screening period. <br>For sites in the EU: A CE certified SARS-CoV-2 PCR test kit is required to confirm infection. <br>For sites outside the EU: SARS-CoV-2 PCR test kits certified according to local regulations are required to confirm infection.<br>4. Body weight at least 50 kg and have a body mass index (BMI) = 18.0 kg/m2 and < 40.0 kg/m2.<br>5. Male or female.<br>6. A female study participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:<br>a. She is not a WOCBP as defined in Section 10.3.1 of the protocol.<br>b. Is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.3.2 of the protocol during the IMP period and for at least 4 weeks after the last dose of IMP. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of IMP.<br>7. A WOCBP must have a negative urine pregnancy test within 24 hours before the first dose of IMP, see Section 8.3.5 of the protocol.<br>a. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required locally. In such cases, the participant must not be randomized if the serum pregnancy result is positive.<br>b. If a serum pregnancy test is required as per local regulations, a serum pregnancy test is required locally. In such cases, the participant must not be randomized if the serum pregnancy result is positive.<br>c. The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetectable pregnancy.<br>8. A male study participant is eligible to participate if:<br>a. He is azoospermic<br>b. The partner is not a WOCBP as defined in Section 1.1.1 of the protocol.<br>c. The partner is a WOCBP and is using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.3.2 of the protocol during the IMP period and for at least 90 days after the last dose of IMP. The investigator should evaluate the potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of IMP.<br>d. He acknowledges that sperm donation is prohibited from the first dose of IMP until at least 90 days after the last dose of IMP.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 120<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 100<br> | Exclusion criteria: <br>1. Patient’s clinical condition is worsening rapidly.<br>2. Requiring ICU admission or ventilator support at screening or at randomization.<br>3. Suspected bacterial, fungal, viral, or other infection (besides COVID-19).<br>4. History of any of the following: malignant disease, autoimmune disease, or severe liver, kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the investigator. The medical monitor should be contacted by the investigator.<br>5. History of hypertension should have hypertension adequately controlled (BP < 140/90 mmHg) with appropriate anti-hypertensive treatment.<br>6. Clinically significant cardiac conduction abnormalities, including QTc prolongation of > 450 milliseconds.<br>7. Family history of Long QT Syndrome.<br>8. Heart failure class 3, or 4, as defined by the New York Heart Association (NYHA).<br>9. History of acute coronary syndrome (including myocardial infarction), coronary angioplasty, or stenting within 24 weeks prior to screening.<br>10. Patients with implanted defibrillators or permanent pacemakers.<br>11. Poorly controlled diabetes mellitus with an HbA1c > 7.5 %.<br>12. Renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome, or renal tubular acidosis.<br>13. Renal failure requiring renal replacement therapy or moderate renal impairment as defined by having an estimated glomerular filtration rate (eGFR, CKD-EPI) < 45 ml/min/1.73m2.<br>14. Chronic Obstructive Pulmonary Disease (COPD) GOLD C, or D, or hospitalization for exacerbation of COPD within 24 weeks prior to screening.<br>15. Other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to chronic respiratory failure.<br>16. Asthma with a symptom control level of "uncontrolled", according to current GINA guidelines.<br>17. Currently suffering from diseases that seriously affect the immune system, such as: human immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, or organ/ stem cell transplantation.<br>18. Known Hepatitis B or C infection.<br>19. Any medical condition, physical examination finding or laboratory abnormality that, in the opinion of the investigator, might confound the results of the study or pose an additional risk to the patient.<br>20. Alanine transaminase (ALT) or aspartate transaminase (AST) >3.0 x ULN.<br>21. Total bilirubin >1.0 x ULN (=1.5 x ULN total bilirubin if known Gilbert’s syndrome).<br>22. Taking concomitant medication metabolized by CYP2C8 and/ or CYP2C9 and listed as “prohibited” in Section 10.5 of the protocol.<br>23. Taking concomitant medication of any experimental treatment or use of marketed medications including off-label use, that are intended as specific treatment for COVID-19. Any such treatments must be washed out for 30 days or at least 5 half-lives prior to randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. Inclusion needs to be approved by the investigator and medical monitor.<br>24. Taking medication that may seriously affect the immune system, e.g. chemotherapy, unless considered and documented as standard of care (e.g. corticosteroids) to treat COVID-19.<br>25. Currently participating in other clinical trials or previous treatment with an investigational medicinal product within 5 half-lives or 30 days (whichever is longer) prior to randomization.<br>26. Known allergy or hypersensitivity to the IMP (including e | Adult hospitalized patients suffering from COVID-19. <br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: ATR-002<br>Product Code: ATR-002<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: ATR-002<br>CAS Number: 303175-44-2<br>Current Sponsor code: ATR-002<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: • Fulfillment of In-/exclusion criteria on day 1<br>• Target variable on day 15;Primary end point(s): • Population: All study participants fulfilling the inclusion and exclusion criteria<br>• Target variable: Clinical severity status on a 7-point ordinal scale at Day 15<br>• Estimator: Odds ratio of ATR-002 in addition to standard of care versus placebo in addition to standard of care with 95% confidence interval <br>;Secondary Objective: • To show that ATR-002 in addition to standard of care shortens the time to clinically relevant improvement of COVID-19 for a hierarchically ordered sequence of time-to-event endpoints<br>• To show that the primary endpoint extended as AUC has a more favorable level under ATR-002 compared to placebo in addition to standard of care over the initial trial period of 30 days in adult hospitalized patients with COVID-19<br>• To explore whether survival time will be prolonged under ATR-002 compared to placebo in addition to standard of care during the initial 30 days of the trial period in adult hospitalized patients with COVID-19;Main Objective: • To demonstrate the efficacy of ATR-002 versus placebo in addition to standard of care based on the clinical severity status in adult hospitalized patients with COVID-19 | | | | Yes | True | parent | |
| → | EUCTR2020-005576-35-HU | 26 July 2021 | COVID-19 Vaccine in Adults 18 Years of Age or Older | A Randomized, Observer-Blind, Placebo-Controlled, Phase 2/3 Study to Assess the Safety, Efficacy, and Immunogenicity of a Recombinant Coronavirus-Like Particle COVID-19 Vaccine in Adults 18 Years of Age or Older
| | Medicago R&D Inc. | 07/04/2021 | 20210407 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005576-35 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 06/05/2021 | 30000 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: yes<br>Other: yes<br>Other trial design description: observer blind<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| United Kingdom;Colombia;Peru;Brazil;Poland;Spain;Argentina;Canada;Mexico;Hungary;United States | Medicago Trial Inquiries | | 1020 route de l’Église, bureau 600 | clinicalTrialInquiries@medicago.com | 581700-19771111 | Medicago R&D Inc. | Inclusion criteria: <br>Subjects must meet all of the following inclusion criteria at the Screening (Visit 1) and/or Vaccination (Visit 2) visits to be eligible for participation in this study; no protocol waivers are allowed. All Investigator assessment-based judgements must be carefully and fully documented in the source documents:<br>1. Subjects must have read, understood, and signed the informed consent form (ICF) prior to participating in the study; subjects must also complete study-related procedures and the subjects must communicate with the study staff at visits and by phone during the study;<br>2. At the Screening visit (Visit 1), male and female subjects must be:<br>• Study Populations #1: 18 to 64 (has not yet had his/her 65th birthday) years of age, inclusive;<br>• Study Population #2: 65 years of age or older;<br>• Study Population #3: 18 years of age or older;<br>3. At Screening (Visit 1) and Vaccination (Visit 2), study populations #1 and #2 must have a body mass index (BMI) of = 18.5 and < 30 kg/m2 for the Phase 2 portion of the study and a BMI of = 18.5 and < 35 kg/m2 for the Phase 3 portion of the study;<br>4. Subjects are considered by the Investigator to be reliable and likely to cooperate with the assessment procedures and be available for the duration of the study;<br>5. Study Populations #1: Subjects must be in good general health prior to study participation, with no clinically relevant abnormalities that could jeopardize subject safety or interfere with study assessments, as determined by medical history, physical examination, and vital signs. Investigator discretion will be permitted with this inclusion criterion;<br>6. Study Populations #1 and #3: Female subjects of childbearing potential must have a negative serum pregnancy test result at Screening (Visit 1 for the Phase 2 portion) and/or a negative urine pregnancy test result at Vaccination (Visit 2 for the Phase 2 portion; Visit 1 for the Phase 3 portion):<br>Non-childbearing females are defined as:<br>• Surgically-sterile (defined as bilateral tubal ligation, hysterectomy or bilateral oophorectomy performed more than one month prior to the first study vaccination); or<br>• Post-menopausal (absence of menses for 12 consecutive months and age consistent with natural cessation of ovulation);<br>7. Study Populations #1 and #3: Female subjects of childbearing potential must use an effective method of contraception for one month prior to vaccination (Visit 2) and agree to continue employing highly effective birth control measures for at least one month after the last study vaccination (or in the case of early termination, she must not plan to become pregnant for at least one month after her last study vaccination).<br>The following relationship or methods of contraception are considered to be highly effective:<br>• Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal;<br>• Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable;<br>• Intra-uterine device with or without hormonal release;<br>• Credible self-reported history of heterosexual vaginal intercourse abstinence prior to and for at least one month after the last study vaccination. Abstinent subjects who are ovulating should be asked what method(s) they would use should their circumstances change, and subjects without a well-defined plan should be excluded;<br>• Female partner;<br>• All regions except the US: Vasectomised partner, provided that | Exclusion criteria: <br>Subjects who meet any of the following criteria at the Screening (Visit 1) and/or Vaccination (Visit 2) visits will not be eligible for participation in this study; no protocol waivers are allowed.<br>All Investigator assessment-based judgements must be thoroughly documented in the source documents:<br>1. Study Populations #1 and #2: According to the Investigator’s opinion, significant acute or chronic, uncontrolled medical or neuropsychiatric illness. Acute disease is defined as presence of any moderate or severe acute illness with or without a fever within 48 hours prior to the Screening (Visit 1) and/or Vaccination visit (Visit 2).<br>‘Uncontrolled’ is defined as:<br>• Requiring a new medical or surgical treatment during the three months prior to study vaccine administration;<br>Requiring any significant change in a chronic medication (i.e. drug, dose, frequency) during the three months prior to study vaccine administration due to uncontrolled symptoms or drug toxicity unless the innocuous nature of the medication change meets the criteria outlined in inclusion criterion no. 5(Study Population #1) or no. 8 (Study Population #2) and is appropriately justified and documented by the Investigator.<br>Investigator discretion is permitted with this exclusion criterion and must be carefully and fully documented in the source documents;<br>2. Study Populations #1 and #2: Any chronic medical condition associated with elevated risk of severe outcomes of COVID-19, including obesity, diabetes (type I/II), significant cardiovascular or respiratory disease including asthma, chronic renal failure, disorders of bleeding/coagulation, chronic inflammatory or autoimmune conditions, immunosuppressive conditions (including HIV), and hypertension; <br>3. Study Populations #1 and #2: Any confirmed or suspected current immunosuppressive condition or immunodeficiency, including cancer, human immunodeficiency virus (HIV), hepatitis B or C infection (subjects with a history of cured hepatitis B or C infection without any signs of immunodeficiency at present time are allowed). Investigator discretion is permitted with this exclusion criterion;<br>4. Study Populations #1 and #2: Current autoimmune disease (such as rheumatoid arthritis, systemic lupus erythematosus,<br>multiple sclerosis or narcolepsy). Investigator discretion is permitted with this exclusion criterion, and subjects may be eligible to participate with appropriate written justification in the source document(i.e. subjects with a history of autoimmune disease who are diseasefree without treatment for three years or more, or on stable thyroid replacement therapy, mild psoriasis [i.e. a small number of minor plaques requiring no systemic treatment], etc.);<br>5. Study Populations #1 and #2: Administration of any medication or treatment that may alter the vaccine immune responses, such as:<br>• Systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per day for more than seven consecutive days or for 10 or more days in total, within one month prior to the Vaccination visit (Visit 2). Inhaled, nasal, ophthalmic, dermatological, and other topical glucocorticoids are permitted;<br>• Cytotoxic, antineoplastic, or immunosuppressant drugs - within 36 months prior to Vaccination (Visit 2);<br>• Any immunoglobulin preparations or blood products, blood transfusion – within 6 months prior to Vaccination (Visit 2);<br>6. Study Population #3: Acute disease defined as presence of any moderate or severe acute illness with or without | Covid-19 <br>MedDRA version: 23.1
Level: LLT
Classification code 10084465
Term: COVID-19 vaccination
System Organ Class: 100000004865
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Coronavirus-Like Particle COVID-19 Vaccine<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: SARS-COV-2, VIRUS-LIKE-PARTICLES<br>Current Sponsor code: CoVLP<br>Other descriptive name: SARS-CoV-2, virus-like-particles<br>Concentration unit: µg/ml microgram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 15-<br>Pharmaceutical form of the placebo: Suspension for injection<br>Route of administration of the placebo: Intramuscular use<br><br> | Timepoint(s) of evaluation of this end point: As defined in endpoints;Primary end point(s): Phase 2 portion<br>In the Phase 2 portion, the primary endpoints are:<br>Safety:<br>• Occurrence, intensity, and relationship to vaccination of immediate AEs (30 minutes after each vaccination);<br>• Occurrence and intensity of solicited local and systemic AEs (for seven days following each vaccine administration);<br>• Occurrence, intensity, and relationship of unsolicited AEs for 21 days following each vaccine administration;<br>• Number and percentage of subjects with normal and abnormal clinically significant urine, haematological and biochemical values prior to and three days following each vaccination;<br>• Occurrences of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths up to 21 days following each vaccine administration;<br>Immunogenicity:<br>• Nab response induced in each Study Population against the SARS-CoV-2 virus on Days 0, 21, and 42 will be analyzed using the following parameter: geometric mean titers (GMT), seroconversion (SC) rate, and geometric mean fold rise (GMFR);<br>• Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus on Days 0, 21, and 42, as measured by IFN-? ELISpot.<br>Phase 3 portion<br>In the Phase 3 portion, the primary endpoint is:<br>Efficacy:<br>• First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection (= 7 days post-second vaccination) in Period 1 and prior to cross-over.;Secondary Objective: Phase 3 portion<br>The secondary objectives of the Phase 3 portion of the study are:<br>Efficacy:<br>• To evaluate the efficacy of the CoVLP formulation, compared to placebo, in the prevention of laboratory confirmed asymptomatic SARS-CoV-2 infection (serologic method) starting 7 days after the second vaccination in Period 1 and prior to the cross-over;<br>• To evaluate the efficacy of the CoVLP formulation, compared to placebo, in the prevention of severe COVID-19 disease starting 7 days after the second vaccination in Period 1 and prior to the cross-over; <br>Please refer the protocol for further details. <br>Immunogenicity:<br>• To assess the immunogenicity of the CoVLP formulation, compared to placebo, in a subset of subjects, as determined by the protocol<br>Safety:<br>• To assess the safety and tolerability of the CoVLP formulation, compared to placebo, up to the end of the study.;Main Objective: Phase 3 portion<br>The primary objective of the Phase 3 portion of the study is:<br>Efficacy:<br>• To evaluate the efficacy of the CoVLP formulation, compared to placebo, in the prevention of laboratory confirmed symptomatic SARS-CoV-2 infection (virologic method) starting 7 days after the second vaccination in Period 1 and prior to the cross-over.→Primary end point(s): Phase 2 portion<br>In the Phase 2 portion, the primary endpoints are:<br>Safety:<br>• Occurrence, intensity, and relationship to vaccination of immediate AEs (30 minutes after each vaccination);<br>• Occurrence and intensity of solicited local and systemic AEs (for seven days following each vaccine administration);<br>• Occurrence, intensity, and relationship of unsolicited AEs for 21 days following each vaccine administration;<br>• Number and percentage of subjects with normal and abnormal clinically significant urine, haematological and biochemical values prior to and three days following each vaccination;<br>• Occurrences of SAEs, MAAEs, AEs leading to withdrawal, AESIs (including VED), and deaths up to 21 days following each vaccine administration;<br>Immunogenicity:<br>• Nab response induced in each Study Population against the SARS-CoV-2 virus on Days 0, 21, and 42 will be analyzed using the following parameter: geometric mean titers (GMT), seroconversion (SC) rate, and geometric mean fold rise (GMFR);<br>• Specific Th1 CMI response induced in each Study Population against the SARS-CoV-2 virus on Days 0, 21, and 42, as measured by IFN-? ELISpot.<br>Phase 3 portion<br>In the Phase 3 portion, the primary endpoint is:<br>Efficacy:<br>• First occurrence, in a subject, of laboratory-confirmed (virologic method) symptomatic SARS-CoV-2 infection (= 7 days post-second vaccination) in Period 1 and prior to cross-over.;Timepoint(s) of evaluation of this end point: As defined in endpoints;Secondary Objective: Phase 3 portion<br>The secondary objectives of the Phase 3 portion of the study are:<br>Efficacy:<br>• To evaluate the efficacy of the CoVLP formulation, compared to placebo, in the prevention of laboratory confirmed asymptomatic SARS-CoV-2 infection (serologic method) starting 7 days after the second vaccination in Period 1 and prior to the cross-over;<br>• To evaluate the efficacy of the CoVLP formulation, compared to placebo, in the prevention of severe COVID-19 disease starting 7 days after the second vaccination in Period 1 and prior to the cross-over; <br>Please refer the protocol for further details. <br>Immunogenicity:<br>• To assess the immunogenicity of the CoVLP formulation, compared to placebo, in a subset of subjects, as determined by the protocol<br>Safety:<br>• To assess the safety and tolerability of the CoVLP formulation, compared to placebo, up to the end of the study.;Main Objective: Phase 3 portion<br>The primary objective of the Phase 3 portion of the study is:<br>Efficacy:<br>• To evaluate the efficacy of the CoVLP formulation, compared to placebo, in the prevention of laboratory confirmed symptomatic SARS-CoV-2 infection (virologic method) starting 7 days after the second vaccination in Period 1 and prior to the cross-over. | | | | Yes | False | | |
| EUCTR2020-005890-29-IT | 26 July 2021 | Multi-arm randomized trial, comparing the efficacy of therapeutic strategies for at home early treatment of mild or moderate COVID-19 (SARS-CoV-2 infection) patients on the reduction of the risk of disease worsening | Comparative efficacy of therapeutic strategies for at home early treatment of mild or moderate COVID-19 patients on the reduction of the risk of disease worsening:
A multi-stage multi-arm adaptive randomized cluster trial - Early Treatment of COVID-19 infection – The ETC study | | FONDAZIONE RICERCA TRASLAZIONALE (FORT) | 22/03/2021 | 20210322 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005890-29 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 12/05/2021 | 810 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: yes<br>Other trial design description: Adaptive, multi-arm, multi-stage, cluster randomised<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Paracetamol alone, not in combination with other IMPs<br>Number of treatment arms in the trial: 3<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Italy | Clinical Operations | | Via San Leonardo trav. Migliaro | etcstudy@cr-technology.com | 0897724155 | Clinical Research Technology | Inclusion criteria: <br>1. Age from 35 to 80 years<br>2. Confirmed SARS-CoV-2 infection, (evidence of infection obtained by COVID-19 swab test prior to consent signing is accepted)<br>3. Patients with mild / moderate symptoms with at least fever and / or painful manifestations such as headache, muscle aches, sore throat, and in addition vomiting and/or diarrhea.<br>4. Signing informed consent<br>5. For female patients: statement of menopausal status or absence of pregnancy<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 570<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 240<br> | Exclusion criteria: <br>1. Age less than 35 years old<br>2. 80 years old in the year of enrollment<br>3. Clinical condition requiring steroid therapy<br>4. Mechanical ventilation needed <br>5. Pregnancy and breastfeeding<br>6. Severe electrolyte imbalances<br>7. History of ventricular cardiac arrhythmias<br>8. Known renal insufficiency (CcCl <30 mL / min or patient on CCRT, haemodialysis or peritoneal dialysis)<br>9. Oncological, haemato-oncological, haematological and / or hepatic disease<br>10. Retinal disease, or hearing loss<br>11. Mental illness<br>12. Skin disorders (including skin rash, dermatitis, psoriasis)<br>13. Patients already on anticoagulant treatment with high / low molecular weight heparins or other parenteral anticoagulants<br>14. Patients at high venous thromboembolic risk according to the Padua score already on prophylaxis with low molecular weight heparin or unfractionated heparin<br>15. Patients with indications for treatment with oral anticoagulants<br>16. Patients on chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs)<br>17. Patients being treated with antivirals<br>18. Patients treated with monoclonal antibodies with direct action on cytokines<br>19. Patients being treated with chloroquine / hydroxychloroquine<br>20. Intolerance to study drugs<br>21. Immunosuppressive therapy in progress or in the last month.<br>22. Patients with severe hepatocellular insufficiency<br>23. Patients with ulcerative colitis or Crohn's disease<br>24. Patients with increased bleeding risk:<br> • Congenital and acquired haemorrhagic diseases<br> • Thrombocytopenia (<25,000 / mm3)<br> • Bleeding in progress<br> • Previous heparin thrombocytopenia<br>25. Women of childbearing age who do not use contraceptives<br>26. Participation in other interventional or observational clinical trials<br> | Mild or moderate COVID-19 (Coronavirus Disease 19), not requiring hospitalization <br>MedDRA version: 23.0
Level: LLT
Classification code 10053983
Term: Corona virus infection
System Organ Class: 100000004862
<br>MedDRA version: 20.0
Level: PT
Classification code 10070255
Term: Coronavirus test positive
System Organ Class: 10022891 - Investigations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Paracetamolo<br>Product Code: [Paracetamolo]<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: PARACETAMOLO<br>Current Sponsor code: Paracetamolo<br>Other descriptive name: Paracetamol<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1000-<br><br>Product Name: Celecoxib<br>Product Code: [Celecoxib]<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: CELECOXIB<br>Current Sponsor code: Celecoxib<br>Other descriptive name: Celecoxib<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 200-<br><br>Product Name: Paracetamolo<br>Product Code: [Paracetamolo]<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: PARACETAMOLO<br>Current Sponsor code: Paracetamolo<br>Other descriptive name: Paracetamol<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 1000-<br><br>Product Name: Enoxaparina<br>Product Code: [Enoxaparina]<br>Pharmaceutical Form: Solution for injection in pre-filled syringe<br>INN or Proposed INN: ENOXAPARINA SODICA<br>Current Sponsor code: Enoxaparina<br>Other descriptive name: Enoxaparin<br>Concentration unit: anti-Xa IU anti-Xa activity International Unit(s)<br>Concentration type: equal<br>Concentration number: 4000-<br><br>Product Name: Enoxaparina<br>Product Code: [Enoxaparina]<br>Pharmaceutical Form: Solution for injection in pre-filled syringe<br>INN or Proposed INN: ENOXAPARINA SODICA<br>Current Sponsor code: Enoxaparina<br>Concentration unit: anti-Xa IU anti-Xa activity International Unit(s)<br>Concentration type: equal<br>Concentration number: 6000-<br><br> | Timepoint(s) of evaluation of this end point: 5 and 10 (±2) days;Primary end point(s): Percentage of patients with worsening of disease symptoms and signs 5-10 (±2) days after initiation of therapy (baseline), i.e. transition from mild to moderate or severe or critical disease, or from moderate to severe disease criticism.;Secondary Objective: • Assess the frequency of hospitalizations in the 3 treatment arms<br>• Evaluate the frequency of nasopharyngeal swab positive patients at the end of the experimental treatment in the 3 treatment arms<br>• Compare safety and tolerability associated with therapeutic regimens proposed in paucisymptomatic patients with SARS-CoV-2 infection treated at home; for patients on treatment with heparins, evaluate the onset of vascular disorders;Main Objective: Identify the most suitable therapeutic scheme to reduce the risk of disease progression towards respiratory failure in paucisymptomatic patients affected by SARS-CoV-2 infection treated at home | | | | Yes | False | | |
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| NCT04423770 | 2 August 2021 | COVID-19 Related Health and Infection Control Practices Among Dentists | COVID-19 Related Health and Infection Control Practices Among Dentists | | American Dental Association | 08/06/2020 | 20200608 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04423770 | Not recruiting | No | 18 Years | N/A | All | June 8, 2020 | 2196 | Observational | | | United States | | Cameron G Estrich, MPH, PhD | | | | American Dental Association Science and Research Institute |
<br> Inclusion Criteria:
<br>
<br> - Primary dental practice is in United States
<br>
<br> - 18 years of age or older
<br>
<br> - Dentist
<br>
<br> Exclusion Criteria:
<br>
<br> •Answered "no" to ADA survey sent May 2020 that read "As part of ongoing efforts to monitor
<br> the effect of COVID-19 on the dental team, the ADA is interested in collecting data related
<br> to infection rates. Would you also be willing to participate in a separate, longitudinal
<br> study that would require you to report whether you or your staff have exhibited symptoms of
<br> COVID-19, and whether you have been tested or diagnosed? The study would be anonymous and
<br> under IRB protocols."
<br> | | Severe Acute Respiratory Syndrome Coronavirus 2 | Other: No intervention | COVID-19 probable or confirmed case | | | | Yes | False | | |
| → | NCT04428801 | 2 August 2021 | Autologous Adipose-derived Stem Cells (AdMSCs) for COVID-19 | Clinical Study for the Prophylactic Efficacy of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells (AdMSCs) Against Coronavirus 2019 (COVID-19) | | Celltex Therapeutics Corporation | 08/04/2020 | 20200408 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04428801 | Not recruiting | No | 18 Years | N/A | All | September 2021 | 200 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). | Phase 2 | | ; | Derek W Guillory, MD.;Sally McGahee | | ;smcgahee@celltexbank.com | ;7135546847 | Root Causes Medicine; |
<br> Inclusion Criteria:
<br>
<br> - Age above 18 years.
<br>
<br> - Male or female
<br>
<br> - Subjects should have banked AdMSCs in Celltex (already passed communicable disease
<br> screen tests for HIV, syphilis, Hepatitis B and C during banking stage)
<br>
<br> - Must understand and voluntarily sign an Informed Consent for study participation
<br> obtained prior to undergoing any study-specific procedures
<br>
<br> - Highly susceptible to SARS-Cov-2 infections, such as obesity (BMI = 40), early to
<br> middle stage of hypertension (systolic pressure ranging above 140 Hg or a diastolic
<br> pressure ranging from 90 mm Hg), diabetic mellitus hemoglobin A1c >8%), chronic heart
<br> disease (one or more conditions including previously diagnosed as coronary artery
<br> disease, chronic heart arrhythmia, cardiomyopathy…) chronic pulmonary disease (COPD,
<br> fibrosis), chronic liver disease (Hepatic impairment, defined as any of ALT, AST, LDH
<br> or bilirubin > 2 x the upper limit of normal (ULN) range according to local laboratory
<br> standards) and kidney diseases (serum creatinine > 133 mmol/L (1.5 mg/dL). No terminal
<br> stages of the above medical conditions.
<br>
<br> - No previous COVID-19 history
<br>
<br> - SARS-CoV-2 RT-PCR or equivalent tests negative in respiratory tract specimen
<br>
<br> - Blood test for SARS-Cov-2 IgM and IgG negative
<br>
<br> Exclusion Criteria:
<br>
<br> - Participation in another clinical study (with use of another Investigational Medical
<br> Product) within 3 months prior to study treatment start
<br>
<br> - Unwillingness or inability to comply with study procedures
<br>
<br> - Blood test for SARS-Cov-2 antibodies IgM and IgG positive
<br>
<br> - Patients with serious basic diseases that affect survival, including blood diseases,
<br> cachexia, active bleeding, severe malnutrition, etc.
<br>
<br> - Clinically active malignant disease
<br>
<br> - Previous thrombotic disorder
<br>
<br> - History of known pulmonary embolism or known secondary anti-phospholipid syndrome
<br>
<br> - Known or suspected hypersensitivity to any components used to culture the AdMSCs, e.g.
<br> BSA and sulfur-containing products (e.g., DMSO)
<br>
<br> - Major trauma or surgery within 14 days of study treatment start
<br>
<br> - Mental condition rendering the subject (or the subject's legally acceptable
<br> representative[s]) unable to understand the nature, scope and possible consequences of
<br> the study
<br>
<br> - Alcohol, drug, or medication abuse within one year prior to study treatment start
<br>
<br> - Any condition in the Investigator's opinion that is likely to interfere with
<br> evaluation of the AdMSC therapy or satisfactory conduct of the study
<br>
<br> - Irreversible severe end-organ failures, such as heart failure/attack, stroke, liver
<br> and renal failure due to other disease conditions
<br>
<br> - Patients or family history with hypercoagulable states, such as protein C/protein S
<br> deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.
<br>
<br> - History of long-term use of immunosuppressive agents
<br>
<br> - Organ transplant in the past 6 months
<br>
<br> - Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth
<br> control during participation in the study duration, unless surgically sterilized or
<br> postmenopausal during the study
<br>
<br> - Patients with severe pulmonary obstructive pneumonia, severe pulmonary interstitial
<br> fibrosis, alveolar proteinosis, allergic alveolitis, and other known viral pneumonia
<br> or bacterial pneumonia. This includes patients with pulmonary imaging that reveals
<br> interstitial lung damage before contracting COVID-19.
<br>
<br> - QT interval shows greater than 450 ms in males and 470 ms in females in the medical
<br> histories or during screen EKG test.
<br> | | COVID-19 | Biological: autologous adipose-derived stem cells | COVID-19 incidence rates in both the study and control groups;The overall proportion of subjects who develop any AEs/SAEs related and non-related with the AdMSC infusions as compared to the control group;Tolerability and acute safety of AdMSC infusion by assessment of the total number of AEs/SAEs related and non-related with the medication→Tolerability and acute safety of AdMSC infusion by assessment of the total number of AEs/SAEs related and non-related with the medication;The overall proportion of subjects who develop any AEs/SAEs related and non-related with the AdMSC infusions as compared to the control group;COVID-19 incidence rates in both the study and control groups | | | | Yes | False | | |
| NCT04432961 | 2 August 2021 | Natural Language Processing (NLP) Analysis of Free Text Notes to Investigate Coronavirus (COVID-19) | A Database and Analytics Study of Free Text Clinical Notes and Structured Data to Investigate Phenotype Associations With Outcomes in Patients With COVID-19 | | Cambridge University Hospitals NHS Foundation Trust | 15/06/2020 | 20200615 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04432961 | Not recruiting | No | 18 Years | 100 Years | All | July 1, 2020 | 200 | Observational | | | United Kingdom | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Male and female
<br>
<br> - Age range: 18 to 100 years
<br>
<br> - Patients admitted to Cambridge University Hospitals with confirmed COVID-19 on lab
<br> testing
<br>
<br> Exclusion Criteria:
<br>
<br> Children and patients with a negative COVID test.
<br> | | COVID-19 | | research database of EHR records from COVID-19 patients processed using NLP tools for named entity recognition and linking adapted to CUH EMR data to identify variables of interest | | | | Yes | False | | |
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| NCT04497194 | 2 August 2021 | Registry of COVID-19 Patients at AOUI Verona | Registry of Biological Samples, Clinical Information and Epidemiological Data of COVID-19 Patients Admitted at the University Hospital of Verona (AOUI Verona) | | Azienda Ospedaliera Universitaria Integrata Verona | 18/05/2020 | 20200518 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04497194 | Not recruiting | No | N/A | N/A | All | March 1, 2020 | 430 | Observational [Patient Registry] | | | Italy | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - PCR for SARS-CoV 2 positive on NPS swab or high suspicion of SARS-CoV 2 with ongoing
<br> swab;
<br>
<br> - All ages;
<br>
<br> - All genders;
<br>
<br> - Informed consent obtained.
<br>
<br> Exclusion Criteria:
<br>
<br> - Failure to obtain the informed consent.
<br> | | Coronavirus Disease 2019 | Other: not applicable (observational study) | Arterial blood gas anaysis HCO3 (mmol/l) in COVID-19 patients admitted to University Hospital of Verona;Arterial blood gas anaysis SpO2 (%) in COVID-19 patients admitted to University Hospital of Verona;Host-related factors associated with the pathogenesis of COVID-19;Virological factors associated with the pathogenesis of COVID-19;Arterial blood gas anaysis pCO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona;Arterial blood gas anaysis pO2 (mmHg) in COVID-19 patients admitted to University Hospital of Verona;Arterial blood gas anaysis pH in COVID-19 patients admitted to University Hospital of Verona;Creatinine (mg/dl) in COVID-19 patients admitted to University Hospital of Verona;ALT (U/L) in COVID-19 patients admitted to University Hospital of Verona;AST (U/L) in COVID-19 patients admitted to University Hospital of Verona;ferritin (mcg/L) in COVID-19 patients admitted to University Hospital of Verona;fibrinogen (g/L) in COVID-19 patients admitted to University Hospital of Verona;D-dimer (µg/L) in COVID-19 patients admitted to University Hospital of Verona;Creatine kinase (CK, U/L) in COVID-19 patients admitted to University Hospital of Verona;L-lattato deidrogenasi (LDH, mU/ml) in COVID-19 patients admitted to University Hospital of Verona;Platelets (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona;Lymphocytes (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona;Neutrophils (cell/mm3) in COVID-19 patients admitted to University Hospital of Verona;White Blood Count (WBC, cell/mm3) in COVID-19 patients admitted to University Hospital of Verona;Procalcitonin (PCT, ng/mL) in COVID-19 patients admitted to University Hospital of Verona;C reactive protein (CRP, m/gL) in COVID-19 patients admitted to University Hospital of Verona;Peripheral oxygen saturation (%) on admission in COVID-19 patients admitted to University Hospital of Verona;Respiratory rate (breaths per minute) on admission in COVID-19 patients admitted to University Hospital of Verona;Pulse rate (beats per minute) on admission in COVID-19 patients admitted to University Hospital of Verona;Blood pressure (mmHg) on admission in COVID-19 patients admitted to University Hospital of Verona;Body temperature (°C) on admission in COVID-19 patients admitted to University Hospital of Verona;Clinical predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona;Epidemiological predictors of poor outcomes in COVID-19 patients admitted to University Hospital of Verona | | | | Yes | False | | |
| → | NCT04502056 | 2 August 2021 | Covid-19 Messaging to Underserved Communities - 2nd Experiment | Covid-19 Messaging to Underserved Communities - 2nd Experiment | | National Bureau of Economic Research, Inc. | 02/08/2020 | 20200802 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04502056 | Not recruiting | No | 18 Years | N/A | All | August 7, 2020 | 20460 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - adults who self-identify as African American or white.
<br>
<br> - an oversample of individuals with less than a college education
<br>
<br> Exclusion Criteria:
<br> | | Covid19 | Behavioral: Acknowledgement Racial Injustice AMA;Behavioral: African American Sender Acknowledgement;Behavioral: African American Sender in Informational Videos.;Behavioral: Racial Inequality Highlighted;Behavioral: AMA Acknowledgement Drug Pricing;Behavioral: White Sender in Acknowledgement;Behavioral: White Sender in Informational Videos;Behavioral: No Racial Inequality Highlighting;Behavioral: Placebo videos | Incidence Rate for Knowledge Gaps: Control vs. Any Intervention;Incidence Rate for Knowledge Gaps: Control vs. Any Intervention - Follow up;Incidence Rate for Information-seeking Behavior: Control vs. Any Intervention;Incidence Rate - Safety Gap Score: Control vs. Any Intervention;Willingness to Pay (WTP) for Masks: Control vs. Any Intervention;Incidence Rate Ratio (IRR) - Knowledge Gap;Incidence Rate Ratio (IRR) - Knowledge Gap - Follow up;Incidence Rate Ratio (IRR) - Information-seeking Behavior;Incidence Rate Ratio (IRR) - Safety Gap Score;OLS Regression Coefficients - Willingness to Pay (WTP) for Masks→OLS Regression Coefficients - Willingness to Pay (WTP) for Masks;Incidence Rate Ratio (IRR) - Safety Gap Score;Incidence Rate Ratio (IRR) - Information-seeking Behavior;Incidence Rate Ratio (IRR) - Knowledge Gap - Follow up;Incidence Rate Ratio (IRR) - Knowledge Gap;Willingness to Pay (WTP) for Masks: Control vs. Any Intervention;Incidence Rate - Safety Gap Score: Control vs. Any Intervention;Incidence Rate for Information-seeking Behavior: Control vs. Any Intervention;Incidence Rate for Knowledge Gaps: Control vs. Any Intervention - Follow up;Incidence Rate for Knowledge Gaps: Control vs. Any Intervention | 27/07/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04502056 | Yes | False | | Yes |
| NCT04506528 | 2 August 2021 | The C3I COVID-19 Project | Investigating the Association Between Smoking Status and COVID-19 Outcomes: Collecting Data From Health Systems Affiliated With the National Cancer Institute's Cancer Center Cessation Initiative (C3I) | | University of Wisconsin, Madison | 07/08/2020 | 20200807 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04506528 | Recruiting | No | N/A | N/A | All | August 10, 2020 | 1000000 | Observational [Patient Registry] | | | United States | ; ; ; ; | Betsy Rolland, PhD, MLIS, MPH;Michael C Fiore, MD, MPH, MBA;Rob Adsit, MEd;Stevens S Smith, PhD;Amy Conlon, MPH | | ;;;sss@ctri.wisc.edu;aconlon@ctri.wisc.edu | ;;;6082627563;608-265-4563 | University of Wisconsin, Madison;University of Wisconsin Center for Tobacco Research and Intervention;University of Wisconsin Center for Tobacco Research and Intervention; |
<br> Inclusion Criteria:
<br>
<br> - COVID-19 positive PCR test
<br>
<br> - a COVID-19 ICD-10-CM diagnosis code during a healthcare visit, or a COVID-19 positive
<br> antibody test
<br>
<br> - Must be a patient in one of the 21 participating healthcare systems
<br>
<br> Exclusion Criteria:
<br>
<br> - N/A
<br> | | Covid19;Cancer;Nicotine Dependence;Pulmonary Disease;Cardiovascular Diseases;Immunosuppression Disorders | | COVID-19 Severity;Mortality due to COVID-19 | | | | Yes | False | | |
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| EUCTR2020-001732-10-DE | 2 August 2021 | Ruxolitinib for treatment of Covid-19 Patienten with acute respiratory
distress syndrome | Ruxolitinib for treatment of Covid-19 induced lung injury ARDS (RuXoCoil)
A single-arm, open-label, proof of concept study
| | Philipps-Universität Marburg | 27/04/2020 | 20200427 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001732-10 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 28/05/2020 | 15 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany | KKS Marburg | | Karl-von-Frisch-Str. 4 | yasmin.moran@kks.uni-marburg.de | +4964212826618 | Koordinierungszentrum für Klinische Studien (KKS) | Inclusion criteria: <br>In order to be eligible to participate in this study, a patient must meet all of the following criteria:<br>1. Male or non-pregnant female adult =18 years of age at time of enrollment.<br>2. has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial or public health assay (result of the PCR is not necessary for inclusion, but has to approved latest within 48-72 hours after registration)<br>3. Willingness of men and women of childbearing potential to use highly effective contraceptive methods by abstinence or by using at least two contraceptive methods from the date of consent to the end of the study<br>4. severe lung disease as defined by following:<br>a. Recent intubation<br>b. Requirement of invasive ventilation moderate to severe pulmonary oxygen exchange disturbance as defined by (PaO2/FiO2) = 200 mmHg at a PEEP = 5mm H2O<br>c. Serum LDH > 283 U/l<br>d. Ferritin above normal value<br>e. CT-scan: pulmonary infiltration compatible with Covid-19 disease<br>5. Patient or patient´s representative must provide written informed consent (and assent if applicable) before any study assessment is performed.<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 5<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 10<br> | Exclusion criteria: <br>An individual who meets any of the following criteria will be excluded from participation in this study:<br>1. Uncontrolled HIV infection<br>2. Active tuberculosis (result of positive tuberculosis infection is not necessary for exclusion, but has to approved later on during patient´s intervention)<br>3. Chronic kidney disease requiring dialysis<br>4. ALT/AST > 5 times the upper limit of normal.<br>5. Pregnancy or breast feeding.<br>6. Allergy to study medication<br>7. Simultaneous participation in another clinical trial with an experimental treatment<br><br><br> | SARS-CoV-2 induced ARDS;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Trade Name: JAKAVI<br>Product Name: Ruxolitinib<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Ruxolitinib<br>CAS Number: 1092939-17-7<br>Current Sponsor code: KKS-278<br>Other descriptive name: RUXOLITINIB PHOSPHATE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 5-<br><br> | Timepoint(s) of evaluation of this end point: 28 days after registration ;Primary end point(s): Overall survival ;Secondary Objective: - Overall survival after 90 days after registration into this trial<br>- Assessment of the duration of ventilation support<br>- Assessment of the extent of cytokine storm reduction (IL-6, CRP, ferritin)<br>- To assess time on ICU<br>- To assess toxicity and safety of ruxolitinib treatment<br>- To assess seroconversion under ruxolitinib (SARS-Co-19- IgG)<br>- If possible to assess pulmonary function (time point discharge from hospital)<br>;Main Objective: Overall survival after 28 days after registration into this trial | | | | Yes | False | | |
| → | EUCTR2020-005979-12-ES | 2 August 2021 | Efficacy and safety of XAV-19 for the treatment of moderate to severe COVID-19 | An international, placebo-controlled, double-blind, randomized clinical trial to evaluate the efficacy and safety of 150 mg XAV-19 infusion, in patients with moderate to severe COVID-19: the EUROXAV study - EUROXAV Study | | XENOTHERA | 01/02/2021 | 20210201 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005979-12 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 26/07/2021 | 722 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Bulgaria;Turkey;Romania;Spain;Greece | Chief Operating Officer | | 1 rue Vauban | bernard.vanhove@xenothera.com | 33255101173 | XENOTHERA | Inclusion criteria: <br>I1) Male or female patient aged 18 years or over, weighing >50 Kg and <120 Kg, at the time of signing the informed consent,<br>I2) Patient presenting in a specialized or an emergency unit <br>I3) Patient presenting signs of pneumonia evidenced by at least 1 of the following: auscultation, chest X-Ray, CT scan OR presenting COVID-19 related symptoms having started less than 10 days prior to screening visit, including at least 2 of the following: fever, cough, sore throat or nasal discharge, dyspnea (shortness of breath), thoracic pain, headache or fatigue, myalgia, anosmia, dysgeusia, diarrhea, nausea <br>I4) Patient with SpO2 > 90% (at ambient air) <br>I5) Patient with a first positive SARS-CoV-2 test (RT-PCR or RT-qPCR) in the last 10 days or at screening<br>I6) WOCBP must have a negative urine pregnancy test at screening and use a highly effective birth control until 90 days after the administration of study drug,<br>I7) Non-vasectomized male patients having a female partner of childbearing potential must agree to use a highly effective method of contraception until 90 days after the administration of study drug,<br>I8) Patient capable of giving signed informed consent.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 288<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 434<br> | Exclusion criteria: <br>E1) Patient with a positive SARS CoV-2 test (RT-PCR or RT-qPCR) of more than 10 days before the screening visit<br>E2) Patient with multiorgan failure<br>E3) Patient requiring immediate Intensive Care Unit (ICU) hospitalization<br>E4) Patient participating in another clinical trial with an investigative agent<br>E5) Pregnancy or breastfeeding<br> | Moderate to severe COVID-19 <br>MedDRA version: 23.1
Level: PT
Classification code 10084460
Term: COVID-19 treatment
System Organ Class: 10042613 - Surgical and medical procedures
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: XAV-19<br>Product Code: XAV-19<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Anti-viral immunoglobulins<br>Current Sponsor code: XAV-19<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 5-<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intravenous use<br><br> | Timepoint(s) of evaluation of this end point: Within 8 days after treatment.;Primary end point(s): The primary endpoint is the proportion of patients with an aggravation of COVID-19 within 8 days after treatment. The aggravation is defined as a worsening of the score of at least 1 point on the WHO 7-point ordinal scale compared to the score on the WHO-7 ordinal scale at randomization.;Main Objective: The primary objective is to compare the clinical efficacy of XAV-19 to that of placebo in patients with COVID-19.;Secondary Objective: The secondary objectives are:<br>- to compare the change in clinical parameters (fever, respiratory rate, shortness of breath, thoracic pain, SpO2, supplemental O2) in patients treated with XAV-19 to that in patients treated with Placebo,<br>- to compare the length of hospital stay of patients treated with XAV-19 to that of patients treated with Placebo,<br>- to compare the viral status of patients treated with XAV-19 to that of patients treated with Placebo, <br>- to compare the safety profile in patients with COVID-19 treated with XAV-19 to that in patients treated with Placebo→Secondary Objective: The secondary objectives are:<br>- to compare the change in clinical parameters (fever, respiratory rate, shortness of breath, thoracic pain, SpO2, supplemental O2) in patients treated with XAV-19 to that in patients treated with Placebo,<br>- to compare the length of hospital stay of patients treated with XAV-19 to that of patients treated with Placebo,<br>- to compare the viral status of patients treated with XAV-19 to that of patients treated with Placebo, <br>- to compare the safety profile in patients with COVID-19 treated with XAV-19 to that in patients treated with Placebo;Timepoint(s) of evaluation of this end point: Within 8 days after treatment.;Primary end point(s): The primary endpoint is the proportion of patients with an aggravation of COVID-19 within 8 days after treatment. The aggravation is defined as a worsening of the score of at least 1 point on the WHO 7-point ordinal scale compared to the score on the WHO-7 ordinal scale at randomization.;Main Objective: The primary objective is to compare the clinical efficacy of XAV-19 to that of placebo in patients with COVID-19. | | | | Yes | True | parent | |
| → | EUCTR2020-002542-16-GR | 2 August 2021 | Treatment of patients with coronavirus infection with immunoglobulin | An International Multicenter, Adaptive, Randomized Double-Blind, Placebo-Controlled Trial of the Safety, Tolerability and
Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Hospitalized
Patients at Onset of Clinical Progression of COVID-19 - Inpatient Treatment with Anti-Coronavirus Immunoglobulin | | Regents of the University of Minnesota | 29/09/2020 | 20200929 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002542-16 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 16/10/2020 | 600 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: yes<br>Other trial design description: adaptive<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Portugal;United States;Nigeria;Greece;Spain;Thailand;Israel;United Kingdom;France;Mexico;Argentina;Belgium;Poland;Peru;Japan;Germany;Denmark→Japan;Germany;Denmark;Peru;Poland;Belgium;Argentina;Mexico;France;United Kingdom;Israel;Thailand;Spain;Greece;Nigeria;United States;Portugal | UCL | | 90 High Holborn str | s.pett@ucl.ac.uk | +442076704700 | MRC CTU | Inclusion criteria: <br>In order to be eligible to participate in this study, a participant must meet all of the following criteria:<br>1. SARS-CoV-2 infection, documented by PCR or other nucleic acid test (NAT) within 3 days prior to randomization OR<br>documented by NAT more than 3 days prior to randomization AND progressive disease suggestive of ongoing SARSCoV-<br>2 infection.<br>2. Symptomatic COVID-19 disease<br>3. Duration of symptoms attributable to COVID-19 = 12 days<br>4. Requiring inpatient hospital medical care for clinical manifestations of COVID-19 (admission for public health or<br>quarantine only is not included)<br>5. Age = 18 years<br>6. Willingness to abstain from participation in other COVID-19 treatment trials until after study day 7<br>7. Provision of informed consent by participant or legally authorized representative<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 80<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 80<br> | Exclusion criteria: <br>1. Prior receipt of SARS-CoV-2 hIVIG or convalescent plasma from a person who recovered from COVID-19 at any time<br>2. Prior receipt of standard IVIG (not hyperimmune to SARS-CoV-2) within 45 days<br>3. Current or predicted imminent (within 24 hours) requirement for any of the following:<br>• Invasive ventilation<br>• Non-invasive ventilation<br>• Extracorporeal membrane oxygenation<br>• Mechanical circulatory support<br> Prior receipt of any SARS-CoV-2 monoclonal antibody treatments at any time<br><br>• Continuous vasopressor therapy<br>4. History of allergy to IVIG or plasma products<br>5. History of selective IgA deficiency with documented presence of anti-IgA antibodies<br>6. Any medical conditions for which receipt of the required volume of intravenous fluid may be dangerous to the patient<br>• Includes New York Heart Association Class III or IV stage heart failure<br>7. Any of the following thrombotic or procoagulant disorders:<br>• Acute coronary syndromes, cerebrovascular syndromes and pulmonary or deep venous thrombosis within 28 days of<br>randomizationHistory of prothrombin gene mutation 20210, homozygous Factor V Leiden mutations, antithrombin III deficiency,<br>protein C deficiency, protein S deficiency or antiphospholipid syndrome<br>8. Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the<br>participant or that could prevent, limit, or confound the protocol-specified assessments<br> | COVID-19 (SARS-CoV-2) infection;Therapeutic area: Health Care [N] - Environment and Public Health [N06] | <br>Product Name: Anti-COVID-19 Hyperimmune Globulin (Human) - Grifols Therapeutics LLC<br>Pharmaceutical Form: Infusion<br>INN or Proposed INN: Anti-COVID-19 hyperimmune globulin(human)<br>Other descriptive name: Anti-SARS-CoV-2 polyclonal hyperimmune globulin<br>Concentration unit: mg/kg milligram(s)/kilogram<br>Concentration type: equal<br>Concentration number: 100-<br>Pharmaceutical form of the placebo: Solution for solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br>Trade Name: Anti-COVID-19 hyperimmune globulin (human) - Takeda Pharmaceuticals<br>Product Name: Anti-COVID-19 hyperimmune globulin (human) - Takeda Pharmaceuticals<br>Pharmaceutical Form: Infusion<br>INN or Proposed INN: Anti-COVID-19 hyperimmune globulin(human)<br>Other descriptive name: Anti-SARS-CoV-2 polyclonal hyperimmune globulin<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 100-<br>Pharmaceutical form of the placebo: Solution for solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br>Product Name: Anti-COVID-19 hyperimmune globulin(human)-Emergent Biosolutions <br>Pharmaceutical Form: Infusion<br>INN or Proposed INN: Anti-COVID-19 hyperimmuneglobulin(human)-Emergent Biosolutions<br>Other descriptive name: Anti-SARS-CoV-2 polyclonal hyperimmune globulin<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 100-<br>Pharmaceutical form of the placebo: Solution for solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br>Product Name: Anti-COVID-19 hyperimmune globulin (human) CSL Behring AG<br>Pharmaceutical Form: Infusion<br>INN or Proposed INN: Anti-COVID-19 hyperimmune globulin(human)-CSL Behring AG<br>Other descriptive name: Anti-SARS-CoV-2 polyclonal hyperimmune globulin<br>Concentration u | Timepoint(s) of evaluation of this end point: Clinical status on Day 7;Primary end point(s): The primary endpoint of this trial in hospitalized patients is an ordinal outcome based on the patient’s clinical status<br>on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated<br>with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications. Categories are:<br>7. Death<br>6. End-organ failure<br>5. Life-threatening end-organ dysfunction<br>4. Serious end-organ dysfunction<br>3. Moderate end-organ dysfunction<br>2. Limiting symptoms due to COVID-19<br>1. No limiting symptoms due to COVID-19;Secondary Objective: 1. All-cause mortality through Day 28.<br>2. The primary ordinal outcome on Days 3, 5, 14 and 28.<br>3. Change in National Early Warning Score (NEWS) from baseline at Day 3. <br>4. Time to the 3 least favourable categories of the primary outcome measure<br>5. Time to the 2 most favourable categories of the primary outcome measure.<br>6. Hospitalization status (alive and discharged from the hospital to home or rehabilitation, versus dead or hospitalized)<br>at Days 7, 14 and 28.<br>7. Time to discharge.<br>8. Days alive outside of a hospital through Day 28.<br><br><br><br>;Main Objective: The primary endpoint of this trial in hospitalized patients is an ordinal outcome based on the patient’s clinical status<br>on Day 7. It includes 7 mutually exclusive categories capturing the range of organ dysfunction that may be associated<br>with progression of COVID-19, such as respiratory dysfunction and coagulation-related complications:7. Death<br>6. End-organ failure<br>5. Life-threatening end-organ dysfunction<br>4. Serious end-organ dysfunction<br>3. Moderate end-organ dysfunction<br>2. Limiting symptoms due to COVID-19<br>1. No limiting symptoms due to COVID-19 | | | | Yes | True | parent | |
| EUCTR2020-005544-34-DE | 2 August 2021 | Double-blind placebo-controlled proof-of-concept trial to demonstrate the anti-viral efficacy of different doses of azelastine in COVID-19 positive patients. | Double-blind placebo-controlled proof-of-concept trial to demonstrate the anti-viral efficacy of different doses of azelastine in COVID-19 positive patients. | | URSAPHARM Arzneimittel GmbH | 28/12/2020 | 20201228 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005544-34 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 04/02/2021 | 90 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 3<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany | Contract Research Organization | | Genter Straße 7 | info@clincompetence.de | +4922171613322 | ClinCompetence Cologne GmbH | Inclusion criteria: <br>Patients must meet all of the following inclusion criteria in order to participate in this study:
<br>
<br>- Legally competent patients who are personally capable of giving informed consent and to date the Consort Form prior to any trial related activity
<br>- Patients aged from 18 - 60 years
<br>- Having the diagnosis of SARS-CoV-2 infection documented by a positive PCR test (patients do not need to suffer from COVID-19 symptoms)
<br>- Enrolment only permitted on the day of availability of positive COVID-19 PCR test result, and on the subsequent day, however, not longer than 48 hours after the swab was taken
<br>- For females: non-pregnant, non-lactating with adequate contraception until D16, or females unable to bear children (i.e., tubal ligation, hysterectomy, or post-menopausal (defined as a minimum of one year since the last menstrual period).
<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 90<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>Patients must not meet any of the following non-inclusion criteria in order to participate in this study:
<br>
<br>- Patients requiring hospitalization,
<br>- Simultaneous participation in other clinical trials or previous participation within 30 days before inclusion,
<br>- No enrolment permitted if COVID-19 testing was performed more than 48 hours ago
<br>- Being in any relationship or dependence with the Sponsor, CRO and/or Investigator,
<br>- Patients being on risk for a serious course of the disease (e.g., insulin-dependent diabetic patients, patients treated with antihypertensive drugs),
<br>- Inability to understand instructions/study documents,
<br>- Inability to administer the nasal spray
<br>- Specific vulnerable patients: subjects who are detained or commited to institutions by law court or by legal authorities, such as psyhiatric wards, prisons or other state institutions
<br>- Any concurrent anti-histamine therapy (systemic as well)
<br>- Any concurrent nasal spray
<br>- Females who are pregnant, lactating, or of child-bearing potential and not using an adequate contraceptive method until D16,
<br>- Having any contraindication for the use of azelastine (incl. hypersensitivity to the active substance or other ingredients).
<br><br> | Diagnosis of SARS-CoV-2 infection documented by a positive PCR test (patients do not need to suffer from COVID-19 symptoms) <br>MedDRA version: 23.1
Level: PT
Classification code 10084460
Term: COVID-19 treatment
System Organ Class: 10042613 - Surgical and medical procedures
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Pollival® 1 mg/ml Nasenspray, Lösung<br>Pharmaceutical Form: Nasal spray, solution<br>INN or Proposed INN: Azelastinhydrochlorid<br>Other descriptive name: AZELASTINE HYDROCHLORIDE<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 1-<br>Pharmaceutical form of the placebo: Nasal spray, solution<br>Route of administration of the placebo: Nasal use<br><br>Product Name: Azelastin 0.02 % nasal spray, solution<br>Pharmaceutical Form: Nasal spray, solution<br>INN or Proposed INN: Azelastinhydrochlorid<br>Other descriptive name: AZELASTINE HYDROCHLORIDE<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 0.2-<br>Pharmaceutical form of the placebo: Nasal spray, solution<br>Route of administration of the placebo: Nasal use<br><br> | Timepoint(s) of evaluation of this end point: Any of the six timepoints (day 2, day 3, day 4, day 5, day 8 and day 11) after baseline (day 1);Primary end point(s): Primary Endpoint<br>First data on efficacy of the treatment with azelastine nasal spray will be assessed by the decrease in median virus load of SARS-CoV-2 between the treatment groups via regular quantitative PCR measurements from nasopharyngeal swabs.<br><br>Primary endpoint of the efficacy of azelastine nasal spray in COVID-positive patients is the baseline adjusted course of the median of virus load in nasopharyngeal swabs of the three treatment groups at any of the six timepoints (day 2, day 3, day 4, day 5, day 8 and day 11) after baseline (day 1). Comparisons will be made via regularly performed quantitative PCR measurements from nasopharyngeal swabs. ;Secondary Objective: Secondary objectives of the trial are: <br>- To assess the clinical impact of the treatment with azelastine nasal spray with regards to the SARS CoV-2 virus shedding. <br>- To assess the clinical impact of the treatment with azelastine nasal spray with regard to symptoms via a patient diary.<br>- To assess the clinical improvement of the patient state<br>- To assess the clinical impact of the treatment with azelastine nasal spray with regards to Quality of Life <br><br>;Main Objective: The primary objective of this study is to assess the first data on efficacy of azelastine nasal spray in SARS-CoV-2 infected patients with regards to virus load in nasopharyngeal swabs. | | | | Yes | True | parent | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04477668 | 10 August 2021 | Helmet Non-Invasive Ventilation for COVID-19 Patients | Helmet Non-Invasive Ventilation for COVID-19 Patients | Helmet-COVID | King Abdullah International Medical Research Center | 09/07/2020 | 20200709 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04477668 | Recruiting | No | 14 Years | N/A | All | February 8, 2021 | 320 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Saudi Arabia | ; ; | Yaseen Arabi, MD;Yaseen Arabi, MD;Yaseen M Arabi, MD | | ;yaseenarabi@yahoo.com;yaseenarabi@yahoo.com | ;011-8011111;+966(1)252-0088 | King Abdulaziz Medical City - Riyadh; |
<br> Inclusion Criteria:
<br>
<br> - Suspected or confirmed COVID-19
<br>
<br> - Aged =14 years old at the participating ICU. ICUs that use other age cut-off for adult
<br> patients will adhere to their local standard (16 or 18 years)
<br>
<br> - Acute hypoxemic respiratory failure based on PaO2/FiO2 ratio <200 despite supplemental
<br> oxygen with a partial or non-rebreathing mask at a flow rate >10 L/min or above
<br>
<br> - Intact airway protective gag reflex
<br>
<br> - Able to follow instructions (e.g. squeeze hand on command, eye contact with care
<br> provider, stick out tongue on command, etc.)
<br>
<br> Exclusion Criteria:
<br>
<br> - Prior intubation during this hospital admission
<br>
<br> - Cardiopulmonary arrest
<br>
<br> - Glasgow coma scale <12
<br>
<br> - Tracheostomy
<br>
<br> - Upper airway obstruction
<br>
<br> - Active epistaxis
<br>
<br> - Requirement for more than one vasopressor to maintain mean arterial pressure > 65 mm
<br> Hg
<br>
<br> - Pregnancy
<br>
<br> - Imminent intubation
<br>
<br> - Patients with do not intubate orders or equivalent
<br>
<br> - Enrolled in another trial for which co-enrolment is not approved including trials on
<br> mechanical ventilation
<br>
<br> - Patients already treated with helmet
<br>
<br> - Patients with chronic carbon dioxide retention (PaCO2 >45)
<br>
<br> - Previous enrolment in this trial
<br>
<br> - The primary cause of respiratory failure is not heart failure as judged by the
<br> treating team
<br> | | COVID-19;Acute Hypoxemic Respiratory Failure | Device: Helmet non-invasive ventilation | 28-day all-cause mortality | | | | Yes | False | | |
| → | NCT04490837 | 10 August 2021 | Rapid Diagnostic Test for COVID-19 Based on Antibody Detection (YCOVID) | Rapid Diagnostic Test for COVID-19 Based on Antibody Detection | YCOVID | Corporacion Parc Tauli | 15/05/2020 | 20200515 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04490837 | Not recruiting | No | 18 Years | N/A | All | June 22, 2020 | 3500 | Observational [Patient Registry] | | | Spain | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Professional from Parc Taulí University Hospital
<br>
<br> - Patients with clinical, radiological and/or PCR COVID-19 positive
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients or professionals who do not sign informed consent
<br> | | Covid-19 | Diagnostic Test: ELISA and Rapid test to detect antibodies against COVID-19 | IgG anti-COVID-19;IgM anti-COVID-19;IgA anti-COVID-19→IgA anti-COVID-19;IgM anti-COVID-19;IgG anti-COVID-19 | | | | Yes | False | | |
| NCT04495842 | 10 August 2021 | The Effect of Aromatherapy on COVID-19-induced Anxiety | The Effect of Aromatherapy on COVID-19-induced Anxiety | | Franklin School of Integrative Health Sciences | 30/07/2020 | 20200730 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04495842 | Recruiting | No | 18 Years | 65 Years | All | October 1, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Participant). | N/A | United States | ; ; | Jessie Hawkins, PhD;PI;Jessie Hawkins, PhD | | ;info@franklinhealth.org;j.hawkins@franklinhealth.org | ;6152613116;615-642-1919 | Franklin School of Integrative Health Sciences; |
<br> Inclusion Criteria:
<br>
<br> - Otherwise healthy
<br>
<br> - Documented COVID-19 exposure, suspected infection, or diagnosed infection
<br>
<br> - Has been tested for or diagnosed with COVID-19
<br>
<br> - adults age 18-65 living in the US
<br>
<br> - understands and agrees to comply with study procedures
<br>
<br> - provides informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Smoker in household
<br>
<br> - Pregnant or may become pregnant
<br>
<br> - Difficulty breathing
<br>
<br> - Pain or pressure in the chest
<br>
<br> - Confusion
<br>
<br> - Hospitalization
<br>
<br> - Asthma, COPD, or other respiratory condition
<br>
<br> - demonstrated inability to comply with study procedures
<br>
<br> - has participated in an interventional clinical study within 31 days prior to
<br> enrollment
<br> | | Stress;Covid19;Anxiety | Other: Essential Oil Blend;Other: Control Blend | Change from baseline in mood state on the Abbreviated Profile of Mood States (POMS);Change from baseline in state anxiety on the State portion of the State Trait Anxiety Scale (STAI-S) at 15 minutes | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04623047 | 10 August 2021 | Using Smart Watches to Detect and Monitor COVID-19 | Using Smart Watches to Detect and Monitor COVID-19 | CovIdentify | Duke University | 09/11/2020 | 20201109 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04623047 | Not recruiting | No | 18 Years | N/A | All | November 1, 2021 | 100000 | Observational | | | United States | ; ; ; ; | Chris Woods;Jessilyn Dunn;Ryan Shaw;Jessilyn Dunn;Jessilyn Dunn | | ;;;covidentify@duke.edu;covidentify@duke.edu | ;;;919-668-9798; | Duke University;Duke University;Duke University; |
<br> Inclusion Criteria:
<br>
<br> - 18 years of age and older
<br>
<br> Exclusion Criteria:
<br>
<br> - Less than 18 years of age
<br> | | Covid19 | | Accuracy of predictive model using smart watch data to predict Covid-19 symptoms as measured by self-reports of symptom questionnaire.;Accuracy of predictive model using smart watch data to predict Covid-19 symptoms as measured by COVID-19 and influenza test result.;Accuracy of predictive model using smart watch data to predict Covid-19 symptoms as measured by hospital admission questionnaire. | | | | Yes | False | | |
| → | NCT04626050 | 10 August 2021 | General Psychological Distress, PTSD, and Co-Morbidities in Healthcare Workers Consequent to COVID-19 | A Brief Phased Two-Step Intervention for Treating General Psychological Distress, PTSD and Co-Morbidities in Healthcare Workers Consequent to the COVID-19 Pandemic | | Weill Medical College of Cornell University | 10/11/2020 | 20201110 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04626050 | Not recruiting | No | 18 Years | N/A | All | September 2021 | 120 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | N/A | United States | ; ; | JoAnn Difede, PhD;Olivia Baryluk, BS;Olivia Baryluk, BS | | ;olb4002@med.cornell.edu; | ;212-821-0783; | Weill Medical College of Cornell University; |
<br> Inclusion Criteria:
<br>
<br> - Any healthcare worker providing medical care or support for COVID-19 patients
<br>
<br> - English-speaking
<br>
<br> - Age >18
<br>
<br> - Medically stable
<br>
<br> - Able to provide informed consent and function at an intellectual level sufficient to
<br> allow accurate completion of all assessment instruments
<br>
<br> - If on psychotropic medication stable for prior 60 days
<br>
<br> For phase II additional inclusion criteria:
<br>
<br> - Current diagnosis of PTSD
<br>
<br> Exclusion Criteria:
<br>
<br> - Current significant unstable medical illness precluding regular session attendance or
<br> assessment completion
<br>
<br> - Participants who in the investigator's judgment pose a current homicidal, suicidal, or
<br> other risk
<br>
<br> - Lifetime or current diagnosis of schizophrenia or other psychotic disorder
<br>
<br> - Participation in a clinical trial or concurrent evidence-based treatment for
<br> psychiatric conditions or PTSD during the previous 3 months.
<br> | | Post-traumatic Stress Disorder;Moral Injury | Behavioral: Medical Music;Behavioral: Narrative Writing;Behavioral: Prolonged Exposure Therapy;Behavioral: Interpersonal Psychotherapy | Feasibility Indicator: Recruitment (Phase I);Feasibility Indicator: Recruitment (Phase II);Feasibility Indicator: Enrollment (Phase I);Feasibility Indicator: Enrollment (Phase II);Feasibility Indicator: Retention (Phase I);Feasibility Indicator: Retention (Phase II);Acceptability Indicator: Satisfaction (Phase I);Acceptability Indicator: Satisfaction (Phase II);Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I);Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II)→Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase II);Preliminary Efficacy as Measured by Change in Clinician-Administered PTSD Scale Score (Phase I);Acceptability Indicator: Satisfaction (Phase II);Acceptability Indicator: Satisfaction (Phase I);Feasibility Indicator: Retention (Phase II);Feasibility Indicator: Retention (Phase I);Feasibility Indicator: Enrollment (Phase II);Feasibility Indicator: Enrollment (Phase I);Feasibility Indicator: Recruitment (Phase II);Feasibility Indicator: Recruitment (Phase I) | | | | Yes | False | | |
| NCT04635241 | 10 August 2021 | Inhaled Heparin for Hospitalised COVID-19 Patients | INHALEd Unfractionated HEParin for the Treatment of Hospitalised Patients With COVID-19 Meta-trial | INHALE-HEP | Australian National University | 14/11/2020 | 20201114 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04635241 | Recruiting | No | 18 Years | N/A | All | June 1, 2020 | 712 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor). | Phase 2/Phase 3 | Egypt;Argentina;Egypt;Argentina | ; | Frank MP van Haren, MD, PhD;Frank MP van Haren, MD, PhD | | ;frank.vanharen@anu.edu.au | ;+61467051809 | Australian National University; |
<br> Inclusion Criteria:
<br>
<br> - Patients admitted to hospital with COVID-19
<br>
<br> - No immediate requirement for mechanical ventilation (points 3-5 on the WHO ordinal
<br> scale)
<br>
<br> - Age equal to or greater than 18
<br>
<br> - Able to provide informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnant women
<br>
<br> - Known allergy to Heparin
<br>
<br> - Participant in another clinical trial that is not approved for joint enrollment.
<br>
<br> - APTT> 120 seconds, not due to anticoagulant therapy.
<br>
<br> - Platelet count <20 x 109 per L
<br>
<br> - Lung bleeding.
<br>
<br> - Uncontrolled bleeding
<br>
<br> - Advanced neurological impairment
<br>
<br> - Advanced oncological disease
<br> | | Covid19 | Drug: Unfractionated heparin | Intubation rate | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2020-001254-22-BE | 10 August 2021 | Sargramostim in patients with acute hypoxic respiratory failure due to COVID-19 | A prospective, randomized, open-label, interventional study to investigate the efficacy of sargramostim (Leukine®) in improving oxygenation and short- and long-term outcome of COVID-19 patients with acute hypoxic respiratory failure. - SARPAC | | University Hospital Ghent | 24/03/2020 | 20200324 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001254-22 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 24/03/2020 | 80 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: standard of care<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Belgium | HIRUZ CTU | | C. Heymanslaan 10 | hiruz.ctu@uzgent.be | +3293320500 | University Hospital Ghent | Inclusion criteria: <br>
<br>- Recent (=2weeks prior to randomization) confident diagnosis of COVID-19 confirmed by antigen detection and/or PCR, and/or seroconversion or any other emerging and validated diagnostic test.
<br>- In some patients, it may be impossible to get a confident laboratory confirmation of COVID-19 diagnosis after 24h of hospital admission because viral load is low and/or problems with diagnostic sensitivity. In those cases, in absence of an alternative diagnosis, and with highly suspect bilateral ground glass opacities on recent (<24h) chest-CT scan (confirmed by a radiologist and pulmonary physician as probable COVID-19), a patient can be enrolled as probable COVID-19 infected. In all cases, this needs confirmation by later seroconversion.
<br>- Presence of acute hypoxic respiratory failure defined as (either or both)
<br>• saturation below 93% on minimal 2 l/min O2
<br>• PaO2/FiO2 below 350
<br>- Admitted to specialized COVID-19 ward
<br>- Age 18-80
<br>- Male or Female
<br>- Willing to provide informed consent
<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 40<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 40<br> | Exclusion criteria: <br>- Patients with known history of serious allergic reactions, including anaphylaxis, to human granulocyte-macrophage colony stimulating factor such as sargramostim, yeast-derived products, or any component of the product.
<br>- mechanical ventilation before start of study
<br>- patients with peripheral white blood cell count above 25.000 per microliter and/or active myeloid malignancy
<br>-patients on high dose systemic steroids (> 20 mg methylprednisolone or equivalent)
<br>-patients on lithium carbonate therapy
<br>- Patients enrolled in another investigational drug study
<br>- Pregnant or breastfeeding females (all female subjects regardless of childbearing potential status must have negative pregnancy test at screening)
<br>- Patients with serum ferritin >2000 mcg/ml (which will exclude ongoing HLH)
<br><br> | Acute hypoxic respiratory failure of COVID-19 patients <br>MedDRA version: 21.1
Level: LLT
Classification code 10074615
Term: Hypoxic respiratory failure
System Organ Class: 100000004855
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Leukine<br>Product Name: Leukine<br>Pharmaceutical Form: Powder for nebuliser solution<br>INN or Proposed INN: SARGRAMOSTIM<br>CAS Number: 123774-72-1<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 250-<br><br>Trade Name: Leukine<br>Product Name: Leukine<br>Pharmaceutical Form: Powder for solution for infusion<br>INN or Proposed INN: SARGRAMOSTIM<br>CAS Number: 123774-72-1<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 250-<br><br> | Timepoint(s) of evaluation of this end point: day 5;Primary end point(s): To measure the effectiveness of sargramostim on restoring lung homeostasis, the primary endpoint of this intervention is measuring oxygenation after 5 DAYS of inhaled (and intravenous) treatment through assessment of pretreatment (day 0) and post-treatment (day 5) ratio of PaO2/FiO2 and through measurement of the P(A-a)O2 gradient, which can easily be performed in the setting of clinical observation of patients admitted to the COVID -19 ward or ICU COVID-19 unit. Preferentially, this measurement should be done in the upright position, while breathing room air for a minimum of 3 minutes.. If this is impossible due to need for supplemental oxygen, FiO2 and oxygen supplementation method should be recorded in patient record, so that A-a gradient can be normalized for age expected normal A-a gradient while on supplemental oxygen use.<br>During the 5 day treatment period, we will perform daily measurements of oxygen saturation (pulse oximetry) in relation to FiO2, and the slope of alterations in this parameters could also be an indicator that our hypothesis is correct.<br>If the patient leaves hospital prior to the day 6 analysis point, oxygenation at day of discharge will be used as value for measuring primary endpoint.<br>;Secondary Objective: - to study if early intervention with sargramostim is safe (number of AEs/SAEs)<br>- to study if early intervention with inhaled sargramostim affects clinical outcome defined by<br>duration of hospital stay, 6-point ordinal scale, clinical sign score, SOFA score, NEWS2 score<br>- to study if early intervention with sargramostim affects the rate of nosocomial infection<br>- to study if early intervention with inhaled sargramostim affects progression to mechanical ventilation and/or ARDS<br>- to study if treatment with sargramostim affects all-cause mortality rate at 4 and 20 weeks post inclusion<br>-to study if treatment with sargramostim affects features of secondary haemophagocytic lymphohistiocytosis, defined by HS score<br>- to study if treatment with sargramostim has a favourable effect on long term 10-20 week follow up<br>;Main Objective: The primary objective is to investigate whether the administration of inhaled sargramostim (Leukine®) at a dose of 250 mcg daily during 5 days improves oxygenation in COVID-19 patients with acute hypoxic respiratory failure . | | | | Yes | False | | |
| → | EUCTR2020-004802-70-FR | 10 August 2021 | Impact of post-Acute respiratory distress syndrome COVID sedation on late neuroinflammation | Impact of post-ARDS COVID sedation on late neuroinflammation - PET-DEXDO COVID | | Assistance Publique – Hôpitaux de Paris | 29/03/2021 | 20210329 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004802-70 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 03/08/2021 | 62 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>Other trial design description: last visit of the last patient<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: <br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| France | Pôle promotion | | DRCI, 1 avenue Claude Vellefaux | marthe.dembele@aphp.fr | +33144841780 | Assistance Publique – Hôpitaux de Paris | Inclusion criteria: <br>• Adult patient (age = 18 years at the time of inclusion) under 75 years old<br>• COVID-19 infection documented by nasopharyngeal pCR test.<br>• High affinity homozygous TPSO genotyping for the radiotracer or heterozygous intermediate affinity for the radiotracer<br>• Patient who was hospitalized in intensive care for an ARDS following the COVID infection requiring mechanical ventilation and deep sedation for at least 48 hours.<br>• Patient alive 12 months (+/- 3 months) after discharge from intensive care<br>• Signature of free and informed consent<br>• Patient affiliated to a social security scheme, excluding AME (state medical aid)<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 31<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 31<br> | Exclusion criteria: <br>• Protected adult (under legal protection, under guardianship or curatorship)<br>• Pregnancy or breast-feeding<br>• Allergy to dexmedetomidine<br>• Contraindication to a PET or MRI examination<br>• Severe renal failure<br>(creatinine clearance <30 ml / min)<br>• Serious neurological history on admission to intensive care:<br>o Stroke<br>o Severe head trauma<br>o Insane state with loss of autonomy<br> | All patients who have developed and survived ARDS linked to COVID-19 infection, admitted to intensive care units, meeting the study's inclusion criteria may be included in this research.;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: dexmedetomidine, all available commercial specialties may have been used (originator or generic)<br>Product Name: dexmedetomidine <br>Product Code: dexmedetomidine <br>Pharmaceutical Form: Concentrate for dispersion for infusion<br><br> | Timepoint(s) of evaluation of this end point: PET-MRI at 12 months (+/- 3 months);Secondary Objective: To assess the association between the biological data, both immunological, transcriptomic and epigenomic, likely to promote or protect the persistence of a neuroinflammatory state at a distance from a severe infection with COVID-19 at 12 months (+/- 3 months) from the intensive care unit<br>Identify the clinical and pharmacological risk factors (in particular the sedative treatments used for ventilatory weaning) for the occurrence of late neuroinflammation defined by an increase in APD on PET-MRI in the frontal lobes and in other regions of interest at 12 months (+/- 3 months) of discharge from intensive care;Main Objective: To assess whether treatment with dexmedetomidine upon removal of sedation to prevent or treat delirium in post-COVID-19 ARDS decreases persistent neuroinflammation measured by an increase in the radiotracer APD in the frontal lobes and detected at 'using PET-MRI performed 12 months (+/- 3 months) after discharge from intensive care.;Primary end point(s): Persistent neuroinflammation is measured by the intensity of the [18F] -DPA-714 signal obtained by PET-MRI imaging at 12 months (+/- 3 months) after leaving the intensive care unit on the 2 frontal lobes (freesurfer segmentation, the intensity of the signal being the ratio of the measurement carried out in the frontal lobes to that carried out in the cerebellar lobes The standard fixation will be expressed as a value indexed with respect to the control value.<br><br>The intensity of the [18F] -DPA-714 signal is the SUV (standard uptake value) or quantity of radioactivity fixed in the tissue which will be measured in each region of interest (frontal lobes and cerebellar lobes = reference) and related to the amount of radioactivity injected for examination.<br>This signal will be corrected by taking into account the weight, the amount of radioactivity injected for the examination as well as the SNPrs6971 genotype (low, medium or high affinity of the radiotracer for its ligand).<br>The ratio of SUV in frontal lobes versus SUV in cerebellar lobes will give us the ratio of radioligand uptake for the area of ??interest.→Timepoint(s) of evaluation of this end point: PET-MRI at 12 months (+/- 3 months);Primary end point(s): Persistent neuroinflammation is measured by the intensity of the [18F] -DPA-714 signal obtained by PET-MRI imaging at 12 months (+/- 3 months) after leaving the intensive care unit on the 2 frontal lobes (freesurfer segmentation, the intensity of the signal being the ratio of the measurement carried out in the frontal lobes to that carried out in the cerebellar lobes The standard fixation will be expressed as a value indexed with respect to the control value.<br><br>The intensity of the [18F] -DPA-714 signal is the SUV (standard uptake value) or quantity of radioactivity fixed in the tissue which will be measured in each region of interest (frontal lobes and cerebellar lobes = reference) and related to the amount of radioactivity injected for examination.<br>This signal will be corrected by taking into account the weight, the amount of radioactivity injected for the examination as well as the SNPrs6971 genotype (low, medium or high affinity of the radiotracer for its ligand).<br>The ratio of SUV in frontal lobes versus SUV in cerebellar lobes will give us the ratio of radioligand uptake for the area of ??interest.;Secondary Objective: To assess the association between the biological data, both immunological, transcriptomic and epigenomic, likely to promote or protect the persistence of a neuroinflammatory state at a distance from a severe infection with COVID-19 at 12 months (+/- 3 months) from the intensive care unit<br>Identify the clinical and pharmacological risk factors (in particular the sedative treatments used for ventilatory weaning) for the occurrence of late neuroinflammation defined by an increase in APD on PET-MRI in the frontal lobes and in other regions of interest at 12 months (+/- 3 months) of discharge from intensive care;Main Objective: To assess whether treatment with dexmedetomidine upon removal of sedation to prevent or treat delirium in post-COVID-19 ARDS decreases persistent neuroinflammation measured by an increase in the radiotracer APD in the frontal lobes and detected at 'using PET-MRI performed 12 months (+/- 3 months) after discharge from intensive care. | | | | Yes | False | | |
| EUCTR2021-000724-35-DE | 10 August 2021 | A Multicenter, Randomized, Double-Blind, Parallel Group Study to Evaluate the Safety, Tolerability and Pharmacokinetics of VIR-7831 in Non-Hospitalized Participants with Mild to Moderate Coronavirus Disease 2019 (COVID-19) | A Multicenter, Randomized, Double-Blind, Parallel Group Phase II Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a Second Generation VIR-7831 Material in Non-Hospitalized Participants with Mild to Moderate Coronavirus Disease 2019 (COVID-19) | | Vir Biotechnology, Inc. | 31/03/2021 | 20210331 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000724-35 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 11/05/2021 | 220 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Part A for PR1 & PR2, Part B for PR2 & PR3<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Korea, Republic of;Germany;Canada;United States | GSK Clinical Trials Help Desk | | 980 Great West Road | GSKClinicalSupportHD@gsk.com | +44 208 990 9733 | GlaxoSmithKline Research & Development Ltd | Inclusion criteria: <br>Participants are eligible to be included in the study only if all of the following criteria apply:
<br>Age
<br> Part A: Participant must be aged 18 years or older at the time of obtaining informed consent.
<br>Part B: Participant must be aged =18 years to <70 years at the time of obtaining informed consent. The additional age restriction of <70 years for Part B is for logistical purposes such that this study and the COMET-TAIL study,(a study administering VIR-7831 via IM injection for which planning is currently ongoing), which are enrolling similar populations (non-hospitalized patients with mild to moderate COVID-19), can utilize many of the same sites for participant enrollment. The
<br>COMET-TAIL study, which requires that a participant is at high risk for progression to severe disease and/or =55 years of age, will be enriching enrollment for participants =70 years of age or older.
<br>Type of Participant and Disease Characteristics
<br>2.Participants who have a positive SARS-CoV-2 test result (by any validated test e.g. RT-PCR on any respiratory type)= 7 days prior to enrollment
<br>AND
<br>Oxygen saturation =94% on room air
<br>AND
<br>Have COVID-19 defined by one or more of the following symptoms: fever, chills, cough, sore throat, malaise, headache, joint or muscle pain, change in smell or taste, vomiting, diarrhea, shortness of breath on exertion
<br>AND
<br>=7 days from onset of symptoms
<br>Sex and Contraceptive/Barrier Requirements
<br>3.No gender restrictions
<br>4.Female participants must meet and agree to abide by the following contraceptive criteria. Contraception use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
<br>A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:
<br>a.Is a woman of non-childbearing potential (WONCBP) as defined in Section 10.4 of protocol
<br>OR
<br>b.Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, as described in Section 10.4 of the protocol during the study intervention period and for up to 24 weeks after the last dose of study intervention. The investigator should evaluate potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.
<br>A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention. See Section 8.4.7 Pregnancy Testing of the protocol.
<br>-If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.
<br>-Additional requirements for pregnancy testing during and after study intervention are located in Section 1.3 of the protocol.
<br>The investigator is responsible for review of medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnancy.
<br>Informed Consent
<br>5.Capable of giving signed informed consent as described in Section 10.1.3 of protocol which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
<br>OR
<br>If participants are not capable of giving written informed consent, alternative consent procedures will be followed as described in Section 10.1 | Exclusion criteria: <br>Participants are excluded from the study if any of the following criteria apply:
<br>Medical Conditions
<br>1.Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours.
<br>2.Symptoms consistent with severe COVID-19 as defined by shortness of breath at rest or respiratory distress or requiring supplemental oxygen.
<br>3.Participants who, in the judgement of the investigator are likely to die in the next 7 days.
<br>4.Severely immunocompromised participants including but not limited to cancer patients receiving immunosuppressive chemotherapy or immunotherapy, those with a solid organ transplant or allogeneic stem cell transplant within the last 3 months, any history of heart or lung transplant or high dose long-term systemic corticosteroids (equivalent to =20 mg a day of prednisone or the systemic equivalent for over 2 weeks).
<br>5.Known hypersensitivity to any constituent present in the investigational product.
<br>6.Previous anaphylaxis or hypersensitivity to a monoclonal antibody.
<br>7.For Part B of the study – Participant has any condition that would prohibit receipt of intramuscular injections in the investigator’s opinion, such as coagulation disorder, bleeding diathesis, or thrombocytopenia
<br>Prior/ Concurrent Clinical Study Experience
<br>8.Enrollment in any investigational vaccine study within the last 180 days or any other investigational drug study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer.
<br>9.Enrollment in any trial of an investigational vaccine for SARS-CoV-2.
<br>Other Exclusions
<br>10.Receipt of any vaccine within 48 hours prior to enrollment. Vaccination will not be allowed for 90 days after dosing.
<br>11.Receipt of convalescent plasma from a recovered COVID-19 patient or anti SARS-CoV-2 mAb within the last 3 months.
<br>12.Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol through Day 29.
<br>13. Participants of legal age who are incapable of comprehending the nature, significance and implications of the clinical trial according to §41 paragraph 3 no. 3, according to German Medicinal Products Act (AMG).
<br>14. Participants who have been committed to an institution by virtue of an order issued either by the judicial or the administrative authorities, according to
<br>§40 paragraph 1 sentence 3 no. 4, German Medicinal Products Act (AMG).
<br>15. Participants must not be in a dependent relationship with the site, investigator or sponsor, according to §40 paragraph 1 sentence 3 no. 3 letter b) and c), German Medicinal Products Act (AMG).<br> | Non-Hospitalized Participants with Mild to Moderate Coronavirus Disease 2019 (COVID-19) <br>MedDRA version: 23.1
Level: LLT
Classification code 10084401
Term: COVID-19 respiratory infection
System Organ Class: 10021881 - Infections and infestations
<br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: VIR-7831, GSK4182136 (Gen 1) IV<br>Product Code: VIR-7831, GSK4182136<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: Sotrovimab (Proposed INN)<br>CAS Number: 2423014-07-5<br>Current Sponsor code: GSK4182136<br>Other descriptive name: VIR-7831<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 25-<br><br>Product Name: VIR-7831, GSK4182136 (Gen 2) IV<br>Product Code: VIR-7831, GSK4182136<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: Sotrovimab (Proposed INN)<br>CAS Number: 2423014-07-5<br>Current Sponsor code: GSK4182136<br>Other descriptive name: VIR-7831<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 62.5-<br><br>Product Name: VIR-7831, GSK4182136 (Gen 2) IM<br>Product Code: VIR-7831, GSK4182136<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Sotrovimab (Proposed INN)<br>CAS Number: 2423014-07-5<br>Current Sponsor code: GSK4182136<br>Other descriptive name: VIR-7831<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 62.5-<br><br> | Primary end point(s): •Occurrence of adverse events (AEs) through Day 29<br>•Occurrence of serious adverse events (SAEs) through Day 29<br>•Occurrence of adverse events of special interest (AESIs) through Day 29<br>•Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) readings through Day 29<br>•Occurrence of disease progression events (not classified as AEs) through Day 29<br>•Mean area under the curve (AUC) of SARS-CoV-2 viral load as measured by quantitative reverse transcriptase polymerase chain reaction (qRT-PCR) from Day 1 to Day 8 (AUCD1-8) in nasopharyngeal swab samples;Secondary Objective: Safety (Part A)-To evaluate the safety and tolerability profile of IV VIR-7831 Gen2 and IV Gen1<br>Safety (Part B)-To evaluate the safety and tolerability profile of VIR-7831 Gen2 administered via IV infusion and IM injection, through Day 29<br>Virology (Part B)-To characterize the effect of VIR-7831 Gen2 IV and IM on viral load clearance in the upper respiratory tract<br>Pharmacokinetics (Part A and Part B)-To assess the pharmacokinetics (PK) of VIR-7831 Gen2 IV and IM and Gen1 IV in serum<br>Safety (Part B)-To evaluate the safety and tolerability profile of VIR-7831 Gen2 administered via IV infusion and IM injection, through End of Study (EOS)<br>Virology (Part A)-To characterize the effect of VIR-7831 Gen2 IV and Gen1 IV on the viral shedding profile in the upper respiratory tract<br>Virology (Part B)-To characterize the effect of VIR-7831 Gen2 IV and Gen2 IM on the viral shedding profile in the upper respiratory tract<br>Refer Protocol, for other Secondary Objective.;Timepoint(s) of evaluation of this end point: Refer E.5.1 for Timepoints;Main Objective: Safety (Part A)<br>To evaluate the safety and tolerability profile of intravenous (IV) VIR-7831 Gen2 and IV Gen1<br><br>Pharmacodynamics (Part B)<br>To evaluate the virological response of VIR-7831 Gen2 administered IV and via intramuscular (IM) injection in the upper respiratory tract<br> | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2021-003331-28-ES | 10 August 2021 | The aim of the study is to analyze whether the administration of a vaccine against COVID19 infection can reduce the symptoms of long COVID. | Randomized, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of the COMIRNATY vaccine (COVID-19 mRNA vaccine, Pfizer-BioNTech) in people with long COVID | | Felix Gutierrez Rodero | 21/06/2021 | 20210621 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-003331-28 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 29/07/2021 | 776 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Spain | Área de Ensayos Clínicos | | Avda de Cataluña, n 21 | rodenas_van@gva.es | | FISABIO | Inclusion criteria: <br>Adults (=18 years) admitted for COVID-19 who continue with moderate or severe symptoms collected in the “COVID-19 Symptom Questionnaire” three months after hospital discharge and who sign the informed consent<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 776<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>-Patients who have received any dose of any of the COVID-19 vaccines.<br>-Contraindication for the COMIRNATY vaccine according to the technical data sheet.<br>-Women who are pregnant or intend to become pregnant during the next three months after the administration of the vaccine.<br> | Unlike what happens with other respiratory viruses, in a significant proportion of patients who have suffered from the disease, general and multi-organ symptoms may persist for months, which has been called long COVID;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Comirnaty<br>Pharmaceutical Form: Concentrate for solution for injection<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intramuscular use<br><br> | Timepoint(s) of evaluation of this end point: The primary end point will be analyzed 12 weeks after the administration of the second dose of the vaccine that is administered 21 (+/- 2) days after the first one.;Primary end point(s): Change in the global score of the “COVID-19 Symptom Questionnaire” at week 12 after the administration of the second dose of COMIRNATY vaccine;Secondary Objective: -To evaluate the effect of the COMIRNATY vaccine on the frequency and intensity of the different general and organic symptoms that persist three months after the acute phase of COVID.<br>-To evaluate the effect of the COMIRNATY vaccine on the quality of life of people with long COVID.<br>-To evaluate the safety of the COMIRNATY vaccine in people with long COVID.;Main Objective: To evaluate the effect of the COMIRNATY vaccine on the frequency and intensity of symptoms that persist three months after the acute phase of COVID. | | | | Yes | False | | |
| → | EUCTR2021-002927-39-AT | 10 August 2021 | Study to test if vaccination with Ad26COVS1 or ChAdOx1-S results in a better immune response compared to a third dose of BNT162b2 or mRNA-1273 in kidney transplant recipients who did not develop an immune response following previous vaccination against COVID-19 | Single blinded randomized controlled trial on BNT162b2 or mRNA-1273 (mRNA) vs Ad26COVS1 or ChAdOx1-S (viral vector) in kidney transplant recipients without SARS-CoV-2 spike protein antibodies following full vaccination against COVID-19 (BOOST-TX) | | Medical University of Vienna | 31/05/2021 | 20210531 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-002927-39 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 13/06/2021 | 200 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: yes<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Austria | Roman Reindl-Schwaighofer | | Spitalgasse 23 | roman.reindl-schwaighofer@meduniwien.ac.at | | Medical University of Vienna | Inclusion criteria: <br>• patient has received a kidney transplantation<br>• full SARS-CoV-2 vaccination with mRNA vaccine (two doses) at least 4 weeks before screening<br>• > 18 years of age<br>• no SARS-CoV-2 spike protein antibodies at least 4 weeks after the second dose of an mRNA vaccine<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 150<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 50<br> | Exclusion criteria: <br>• acute illness with fever<br>• Prior documented infection with SARS-CoV-2<br>• triple anticoagulation therapy<br>• Subject is currently enrolled in or has not yet completed at least 30 days since ending other investigational device or drug trial(s), or subject is receiving other investigational agent(s)<br>• Subject has known sensitivity or intolerance to any of the products to be administered for the purpose of this study<br>• Subject has any kind of disorder that compromises the ability of the subject to give written informed consent and/or to comply with the study procedures<br>• Subject is pregnant or breast feeding<br><br> | Patients following kidney transplant recipients who do not have an adequate immune response against SARS-CoV-2 following complete vaccination;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | <br>Trade Name: COVID-19 Vaccine Janssen<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: Adenovirus type 26 encoding the SARS-CoV-2 spike glycoprotein (Ad26.COV2-S)<br>Other descriptive name: COVID-19 Vaccine Janssen (Ad26.COV2.S)<br>Concentration unit: IU international unit(s)<br>Concentration type: not less then<br>Concentration number: 8.92 log(10)-<br><br>Trade Name: Comirnaty<br>Pharmaceutical Form: Concentrate for dispersion for injection<br>INN or Proposed INN: Single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the v<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br>Trade Name: COVID-19 Vaccine Moderna<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: Single-stranded, 5’-capped messenger RNA (mRNA) produced using a cell-free in vitro transcription from the corresponding DNA templates, encoding the v<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br>Trade Name: Vaxzevria<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: Chimpanzee Adenovirus encoding the SARS-CoV-2 Spike glycoprotein (ChAdOx1-S)<br>Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)<br>Concentration type: not less then<br>Concentration number: 2.5x10^8-<br><br> | Timepoint(s) of evaluation of this end point: Visit 3 at 4 weeks after vaccination for primary endpoint;Primary end point(s): Number of patients presenting a positive humoral immune response (antibody) at 4 weeks after vaccination;Secondary Objective: To evaluate the cellular immune response against SARS-CoV-2 following vaccination;Main Objective: To evaluate if a switch to a vector-based vaccine improves immunological response (ie. development of antibodies) against SARS-CoV-2 in kidney transplant recipients compared to a third dose of the previously applied mRNA vaccine→Main Objective: To evaluate if a switch to a vector-based vaccine improves immunological response (ie. development of antibodies) against SARS-CoV-2 in kidney transplant recipients compared to a third dose of the previously applied mRNA vaccine;Secondary Objective: To evaluate the cellular immune response against SARS-CoV-2 following vaccination;Primary end point(s): Number of patients presenting a positive humoral immune response (antibody) at 4 weeks after vaccination;Timepoint(s) of evaluation of this end point: Visit 3 at 4 weeks after vaccination for primary endpoint | | | | Yes | False | | |
| ISRCTN77100098 | 10 August 2021 | Testing a different centring point for pelvic x-rays | STandardisation Of suPine Pelvic rAdioGraph tEchnique (STOPPAGE). Validating a different centring point for pelvic radiographs in a supine position | | Anglo-European College of Chiropractic | 28/07/2021 | 20210728 | ISRCTN | https://www.isrctn.com/ISRCTN77100098 | Recruiting | No | | | Both | 01/08/2021 | 314 | Interventional | Non-randomized; Both; Design type: Process of Care, Imaging, Cross-sectional (Diagnostic) | Not Applicable | United Kingdom | | | | | | | Inclusion criteria: All patients referred for a pelvic radiograph from outpatient (OP) clinics and general practitioners (GPs) | Exclusion criteria: <br> 1. Patients referred for one or both hip radiographs (XHIPB) as the resultant images do not include the same anatomy as a true pelvis radiograph<br> 2. Anyone with a hip prosthesis as the anatomical measures will not be valid<br> 3. Immobile patients who may need additional adjustments to techniques<br> 4. Patients <18 years old or pregnant<br> 5. Those unable to read the participant information leaflet (PIS) or unable to provide informed written consent due to a lack of capacity (Mental Capacity Act)<br> 6. Patients who are prisoners or in police custody to minimise examination times, reduce anxiety and overall risk<br> | Pelvic radiograph <br>Not Applicable | <br> This study will test the different centring point for reliability and acceptability. Two NHS clinical sites in England will be used with one undertaking pelvis radiography according to the different technique (intervention site) and the other continuing with standard practice (active control site).<br><br> Retrospective audit:<br> Pelvic radiographs from both sites obtained for the same time period (June to October 2019, to reflect practice not affected by COVID) to identify any recurrent issues with quality (rotation, included anatomy, and image quality). Differences and similarities between the two cohorts will be assessed.<br><br> Prospective data collection:<br> All radiographers at the interventional site will undertake training on the different centring point, consisting of a video presentation and online Q&A session to embed the different technique. The training will be based on the literature, retrospective audit, and the findings of a recent unpublished evaluation that demonstrated high variability of centring points within pelvic radiographs and supported the proposal for a different centring point. The control group will also have a refresher update on pelvic positioning based on the retrospective audit. They will then continue with their usual practice.<br> During the data collection period radiographers at both sites will complete the CRF to determine their ease of locating the bony landmarks and be asked to rate their resultant radiograph. They will also be asked to provide any free text comments regarding the positioning technique they used. (Acceptability of the positioning technique for patients will not be assessed as all their data will be anonymised at source and unless they have | The reliability of the evidence-based centring point in the different technique versus usual care for sagittal, axial and coronal rotation, image quality and included anatomy, assessed by image review of radiographs at a single timepoint | | 31/12/2021 | | Yes | False | | |
| → | ISRCTN15354495 | 10 August 2021 | Randomised trial optimising COVID-19 vaccination in patients with chronic health conditions and a poor response to standard vaccination | A Phase III, multicentre, randomised trial comparing SARS-CoV-2 re-boost vaccine strategies in immunocompromised patients | | University of Birmingham | 26/07/2021 | 20210726 | ISRCTN | https://www.isrctn.com/ISRCTN15354495 | Recruiting | No | | | Both | 26/07/2021 | 1200 | Interventional | Phase III multi-centre multi-disease open-label randomized trial (Prevention) | Phase III | United Kingdom | Ana;Iain→Iain;Ana | Hughes;McInnes |
Cancer Research UK Clinical Trials Unit
Institute of Cancer & Genomic Sciences
University of Birmingham
Edgbaston
;
University of Glasgow
Wolfson Medical School Building
University Avenue
| octave-duo@trials.bham.ac.uk;Iain.McInnes@glasgow.ac.uk | +44 (0)121 4143100;+44 (0)141 332378 | ; | Inclusion criteria: <br> 1. Aged =18 years<br> 2. Have an inadequate response to two doses of SARS-CoV-2 vaccine measured at least 14 days after receipt of the second vaccine, defined by SARS-CoV-2 spike antibody response. An inadequate response is defined as:<br> 2.1. Antibody non-response: SARS-CoV-2 anti-spike antibodies below the level of detection using the PHE Roche platform [or equivalent] =8 AU/ml, or<br> 2.2. Antibody low-response: SARS-CoV-2 anti-spike antibodies >8 and <400 AU/mL using the Roche platform [or equivalent])<br> 2.3. There is no agreed international/WHO cut off for titres of AU following vaccination and serologic assessment. As such, the low responder status for OCTAVE-DUO eligibility is by definition arbitrary. We have examined the serology levels obtained in the OCTAVE study, compared with PITCH (health care workers without vulnerable conditions) and elected to choose a titre that equates to approximately 30% of the OCTAVE population – this equates to approx. 400 AU hence this selection for this part of the eligibility criteria. Since in practice all vulnerable groups will receive a re-boost in due course, by choosing the lowest tertile for evaluation of enhancement of response, we are maximising the pragmatic value of the study in terms of policy advice, and determination of the magnitude of the immune response, representing our primary outcome. Moreover, we are thereby ensuring rapid and representative recruitment from the variety of vulnerable patient groups in the study protocol.<br> 3. Anticipated life expectancy of 6 months or greater.<br> 4. Fall into one (or more) of the following patient cohorts who will meet disease-relevant classification, disease state, and staging according to established international standards:<br> 4.1. Diagnosed with any of the following solid cancers:<br> 4.1.1. Breast<br> 4.1.2. Lung<br> 4.2. Diagnosed with any of the following lymphoid malignancy categories:<br> 4.2.1. Aggressive B-NHL<br> 4.2.2 Chronic lymphocytic leukemia (CLL)<br> 4.2.3. Hodgkin Lymphoma<br> 4.2.4. Indolent B NHL (except CLL and small lymphocytic lymphoma [SLL])<br> 4.2.5. Myeloma<br> 4.3. Diagnosed with the following rheumatic/inflammatory conditions:<br> 4.3.1. Rheumatoid arthritis<br> 4.3.2. Psoriatic arthritis<br> 4.3.3. Seronegative arthritis<br> 4.3.4. Spondyloarthritis<br> 4.3.5. ANCA-associated vasculitis<br> 4.3.6. Systemic lupus erythematosus (SLE)<br> 4.3.7. Psoriasis<br> 4.3.8. Crohn’s disease/ulcerative colitis<br> 4.3.9. Autoimmune hepatitis<br> 4.4. Diagnosed with the following chronic renal conditions:<br> 4.4.1. End-stage kidney disease secondary to any cause<br> 4.4.2. Renal transplant following end-stage kidney disease<br> 4.5. Diagnosed with the following chronic liver conditions:<br> 4.5.1. Liver cirrhosis<br> 4.5.2. Liver transplantation<br> 4.6. Chronic liver disease (of any stage) on immune suppressive therapy<br> 4.6.1. Diagnosed with gastrointestinal disease and on immune suppressive therapy<br> 4.7. Diagnosed with primary antibody deficiency: defined as any patient who is on immuno | Exclusion criteria: <br> 1. Receipt of any vaccine within 30 days before trial entry, with the exception of a SARS-CoV2 vaccine which is allowed =14 days prior, or a flu vaccination which is allowed =7 days prior<br> 2. For aggressive B-NHL or Hodgkin lymphoma only, participants on active systemic treatment or within 4 weeks of completion of systemic treatment<br> 3. Any known contraindications as specified in the applicable product information (see Section 7.1) including but not limited to:<br> 3.1. Known allergy or hypersensitivity to any of the trial IMPs or any of the trial drug excipients<br> 3.2. History of anaphylaxis<br> 4. In the judgement of the Investigator the patient is unsuitable to participate in the trial or is unlikely to comply with trial procedures<br> 5. For the randomised sub-study only, patients who are pregnant at trial entry or planning to become pregnant within 3 months after re-vaccination<br> | Patients with 1) solid cancer; 2) lymphoid malignancies; 3) immune-mediated rheumatic diseases; 4) end stage kidney disease; 5) liver disease; 6) inflammatory bowel disease on immune suppressive therapy; 7) haematopoietic stem cell transplant; and 8) primary immunodeficiency who have received two doses of SARS-CoV-2 vaccine but have proven inadequate response to the SARS-CoV-2 vaccine <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> For the main study randomised comparison, patients will randomised using a minimisation program (developed by the CRCTU) in a 1:1 ratio. Patients will be randomised to receive:<br> Arm 1: Pfizer SARS-CoV2 Vaccine<br> Arm 2: Moderna SARS-CoV2 Vaccine<br><br> For the sub-study randomised comparison, patients will be randomised using a minimisation program in a 1:1:1 ratio. Patients will be randomised to receive:<br> Arm 1: Pfizer SARS-CoV2 Vaccine<br> Arm 2: Moderna SARS-CoV2 Vaccine<br> Arm 3: Novavax SARS-CoV2 Vaccine<br><br> The dose of Pfizer vaccine is 30 µg contained in 0.3 ml of the diluted vaccine given intramuscularly.<br> The dose of Moderna vaccine is 0.5 ml, containing 100 micrograms of messenger RNA (mRNA), given intramuscularly.<br> The dose of Novovax vaccine is 5 µg recombinant spike protein with 50 µg Matrix-M1 adjuvant (0.5 ml). A dose of 5 µg recombinant spike protein with 50 µg Matrix-M1 adjuvant (0.5 ml) will be given intramuscularly.<br><br> Where possible participants will be followed up in accordance with standard clinical practice for the relevant disease cohort and data will be collected retrospectively from clinic records 3 months after re-boost vaccination. Where participants do not attend for a routine clinic visit, data may be collected following an additional telephone follow-up call.<br> | <br> 1. Anti-spike SARS-CoV-2 antibody and T cell responses to SARS-CoV-2 peptides following Pfizer and Moderna re-boost vaccinations will be measured before the re-boost vaccination was given and will be compared with those achieved at day 21 post dose:<br> 1.1. Anti-spike SARS-CoV-2 antibodies following re-boost vaccination will be measured using the Roche platforms by the Public Health England (PHE) Laboratories at Porton Down. The Roche assays will measure the presence and amount of serum antibodies to both the spike (S) and the nucleocapsid (N) antigens of SARS-CoV-2. This assay will enable the discrimination of antibody responses to SARS-CoV-2 that results from vaccination and/or SARS-CoV-2 infection.<br> 1.2. T cell responses to SARS-CoV-2 peptides following re-boost vaccination will be measured using the Oxford Immunotec modified T-spot discovery SARS-CoV-2 assay. This IFN? ELISpot assay will provide insights into the participants’ reactivity to SARS-CoV-2 s1, s2, nucleocapsid and membrane peptides.<br> | | 18/04/2023 | | Yes | False | | |
| ISRCTN13857593 | 10 August 2021 | Study on the performance and safety of Sentinox in COVID-19 patients | Post-market, confirmatory, interventional, randomized and controlled clinical study to assess the efficacy and safety of Sentinox in COVID-19 patients | | Applied Pharma Research (Switzerland) | 12/05/2021 | 20210512 | ISRCTN | https://www.isrctn.com/ISRCTN13857593 | Recruiting | No | | | Both | 20/05/2021 | 57 | Interventional | Single-centre open-label randomized controlled interventional study (Treatment) | Not Applicable | Italy | | | | | | | Inclusion criteria: <br> Current inclusion criteria as of 29/07/2021:<br> 1. Patient informed consent form (ICF) signed<br> 2. Aged =18 and =64 years at the time of the signature of ICF<br> 3. Subjects who are willing to comply with the requirements of the study protocol, attend scheduled visits and calls for the duration of the study by telephone contact<br> 4. Mild Symptomatic Individuals with COVID-19 confirmed by polymerase chain reaction (PCR) based on WHO guideline (version as of 27/05/2020). In the study will be enrolled COVID-19 patient with RT-PCR Ct value =30 for =2 genes out of 4, at the first swab. The enrollment of COVID-19 vaccinated patients will be allowed if they will present a “clinical vaccination failure”, defined according to the indications reported in the “Global Manual on Surveillance of AE Following Immunization” (WHO guidelines)<br> 5. Onset of symptoms from not more than 2/3 days<br><br> Previous inclusion criteria:<br> 1. Patient informed consent form (ICF) signed<br> 2. Aged =18 and <64 years at the time of the signature of ICF<br> 3. Subjects who are willing to comply with the requirements of the study protocol, attend scheduled visits and calls for the duration of the study by telephone contact<br> 4. Mild Symptomatic Individuals with COVID-19 confirmed by polymerase chain reaction (PCR) based on WHO guideline (version as of 27/05/2020). In the study will be enrolled COVID-19 patient with RT-PCR Ct value <30 for =2 genes out of 4, at the first swab.<br> 5. Onset of symptoms from not more than 2/3 days<br> | Exclusion criteria: <br> Current exclusion criteria as of 29/07/2021:<br> 1. Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases)<br> 2. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values<br> 3. Immune system illnesses<br> 4. Known drug and/or alcohol abuse<br> 5. Individuals who are cognitively impaired and/or who are unable to give informed consent<br> 6. Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19<br> 7. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day<br> 8. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 h<br> 9. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV)<br> 10. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity<br> 11. Prior hospitalization for COVID-19<br> 12. Positive pregnancy test or breastfeeding woman<br> 13. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient<br> 14. History of severe drug and/or food allergies and/or known allergies to the trial product or its components<br> 15. Any condition that, in the opinion of the Investigator, would complicate or compromise the study or well-being of the patient<br><br> Previous exclusion criteria:<br> 1. Other clinically significant and uncontrolled pathologies that may interfere with study results (e.g. rheumatic diseases)<br> 2. Presence of any relevant organic, systemic or metabolic disease (particularly significant history of cardiac, renal, neurological, psychiatric, oncology, endocrinology, metabolic or hepatic disease), or abnormal laboratory values that will be deemed clinically significant based on predefined values<br> 3. Immune system illnesses<br> 4. Known drug and/or alcohol abuse<br> 5. Individuals who are cognitively impaired and/or who are unable to give informed consent<br> 6. Ongoing or prior participation in any other clinical trial of an experimental treatment for COVID-19 (including COVID-19 vaccine)<br> 7. Vaccination with COVID-19 vaccine<br> 8. Ongoing or prior participation in any other clinical trial of an experimental treatment within 30 days from enrollment day<br> 9. Intubated or prior intubation (during present hospitalization) or anticipated intubation within the subsequent 2 h<br> 10. Using high-flow nasal cannula (HFNC) or non-invasive ventilation (NIV)<br> 11. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity<br> 12. Prior hospitalization for COVID-19<br> 13. Positive pregnancy test or breastfeeding woman<br> 14. Known hypersensitivity to the study treatment, its metabolites, or formulation excipient<br> 15. History of severe dr | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> This is a single-center, randomized, controlled, open-label, pilot study to assess the safety and the performance of Sentinox medical device in the treatment of mild COVID-19 patients.<br><br> The study will consist of 9 visits.<br> At the screening visit, according to the investigational site procedures, patients with a positive COVID-19 nasopharyngeal swab (quantitative swab test with RT-PCR Ct value =30 for at least 2 genes out of 4) performed at the investigational site on the same day will be summoned. Patients will be enrolled after having signed the informed consent form prior to any other study procedure and after inclusion/exclusion criteria check. According to the investigator's judgment, the patient’s clinical outcomes, and the investigational site guidelines, the enrolled patients should be hospitalized or redirected to other structures (e.g. “COVID-19 hotel”, patient’s home).<br><br> At Visit 0 (day 0), the patient will be randomized with a 1:1:1 ratio in one of 3 trial groups:<br> 1. Group A: Sentinox treatment performed 3 times/day for 5 days (as add-on to the standard therapy);<br> 2. Group B: Sentinox treatment performed 5 times/day for 5 days (as add-on to the standard therapy);<br> 3. Group C: no Sentinox treatment; only the standard therapy will be performed.<br><br> The allocation of the patient in one of the three study arms will be performed sequentially by the principal investigator or delegates in the order in which the subjects are enrolled and will be reported in a randomization list, including the identification code of the patient and the treatment arm (A, B or C) assigned. The randomization list, retained in the investigation site, is limited to the | 1. Viral load in COVID-19 patients measured using quantitative swab test with RT-PCR at baseline, 1, 2, 3, 4, 5, 6, 10, and 21 days (three swabs daily on day 1 and 2, and one swab daily on other days) | | 31/12/2021 | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04445259 | 17 August 2021 | Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury | Study of the Treatment and Outcomes in Critically Ill Patients With COVID-19 and High Risk of Acute Kidney Injury | | Guy's and St Thomas' NHS Foundation Trust | 27/05/2020 | 20200527 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04445259 | Recruiting | No | 18 Years | N/A | All | June 20, 2020 | 300 | Observational | | | United Kingdom | ; ; | Nuttha Lumlertgul, MD, PhD;Marlies Ostermann, MD, PhD;Marlies Ostermann, MD, PhD | | ;Marlies.Ostermann@gstt.nhs.uk;Marlies.Ostermann@gstt.nhs.uk | ;0044 207 188 3038;020 71883038 | Guy's & St Thomas' Hospital; |
<br> Inclusion Criteria:
<br>
<br> 1. Adults (aged =18 years)
<br>
<br> 2. Confirmed diagnosis of COVID-19
<br>
<br> 3. Hospitalized in the ICU for illness related to COVID-19
<br>
<br> 4. Any of the following:
<br>
<br> - Current in-patient in ICU
<br>
<br> - Previous in-patient in ICU and died in ICU or hospital
<br>
<br> - Previous in-patient in ICU and discharged from ICU alive
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Younger than 18 years old
<br>
<br> 2. On chronic dialysis within the last year or on dialysis at ICU admission
<br>
<br> 3. Functioning kidney transplant
<br>
<br> 4. No creatinine within 48 hours of ICU admission
<br> | | COVID;Acute Kidney Injury;Critical Illness | | Incidence of any stage of acute kidney injury | | | | Yes | False | | |
| → | NCT04452669 | 17 August 2021 | VentaProst in Subjects With COVID-19 Requiring Mechanical Ventilation | Double-blind, Placebo Controlled Study to Assess the Efficacy and Safety of VentaProst (Inhaled Epoprostenol Delivered Via Dedicated Delivery System) in Subjects With COVID-19 Requiring Mechanical Ventilation | VPCOVID | Aerogen Pharma Limited | 29/06/2020 | 20200629 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04452669 | Not recruiting | No | 18 Years | N/A | All | September 15, 2020 | 11 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | United States | | Veronica Franco, MD | | | | Ohio State University |
<br> Inclusion Criteria:
<br>
<br> - Confirmed COVID-19 positive by RT-PCR test
<br>
<br> - Patients who require invasive mechanical ventilation.
<br>
<br> - Consent or professional consent obtained
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients on ECMO support.
<br>
<br> - Patients receiving another inhalation research medication or inhaled nitric oxide.
<br>
<br> - Not expected to survive for 48 hours.
<br>
<br> - Allergy to Epoprostenol and its diluent
<br> | | COVID-19 | Drug: VentaProst (inhaled epoprostenol delivered via a dedicated delivery system) | Reduction in Cardiac/Circulatory Failure;Reduction in Respiratory Failure→Reduction in Respiratory Failure;Reduction in Cardiac/Circulatory Failure | | | | Yes | False | | |
| NCT04459351 | 17 August 2021 | PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs | PHenotyping patiENts Admitted to Hospital With cOvid-19 Infection and idenTifYing Prognostic markErs | PHENOTYPE | Chelsea and Westminster NHS Foundation Trust | 18/06/2020 | 20200618 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04459351 | Recruiting | No | 18 Years | N/A | All | June 19, 2020 | 500 | Observational | | | United Kingdom | ; ; | Pallav Shah, MBBS, MD;Research Delivery Operations Manager;Research Delivery Operations Manager | | ;research.development@chewest.nhs.uk;research.development@chelwest.nhs.uk | ;020 3315 6825;020 3315 6825 | Chelsea and Westminster Hospital NHS Foundation Trust; |
<br> Inclusion Criteria
<br>
<br> - Aged 18 years or older
<br>
<br> - Confirmed COVID-19 infection (as per national guidelines)
<br>
<br> - Attending follow-up outpatient visit post hospital attendance with COVID-19 infection
<br>
<br> Exclusion Criteria
<br>
<br> There are no specific exclusion criteria
<br> | | Coronavirus;Corona Virus Infection;COVID-19;2019nCoV;2019 Novel Coronavirus Infection | | Genomic analysis of blood samples to look for genetic susceptibility to severe disease presentations;Identification of blood biomarkers which correlate with disease severity;Identification of baseline characteristics which correlate with disease severity | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04674566 | 17 August 2021 | Evaluation of Safety and Tolerability of COR-101 in Hospitalized Patients With Moderate to Severe COVID-19 | Randomized, Double-blind, Placebo Controlled, Parallel Group, Multi-centre, First-in-human, Phase Ib/II Study to Assess Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of COR-101 in Hospitalized Patients | | Corat Therapeutics Gmbh | 17/12/2020 | 20201217 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04674566 | Recruiting | No | 18 Years | N/A | All | April 21, 2021 | 45 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 1/Phase 2 | Germany | ; ; | Helmut Salih;Marie-Ann Dhaen;Helmut Salih | | ;m.dhaen@corat-therapeutics.com; | ;+4981313563724; | University Hospital Tübingen; |
<br> Key Inclusion Criteria:
<br>
<br> - Hospitalized for COVID-19 illness for =72 hours
<br>
<br> - Positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test
<br>
<br> - Presence of moderate to severe clinical signs indicative of moderate or severe illness
<br> with COVID19 prior to study treatment
<br>
<br> Key Exclusion Criteria:
<br>
<br> - Diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19
<br>
<br> - In the opinion of the investigator, is not likely to survive for >48 hours beyond Day
<br> 1
<br>
<br> - New onset stroke or seizure disorder during hospitalization and prior to Day 1
<br>
<br> - History of relevant CNS pathology or current relevant CNS pathology
<br> | | Covid19 | Drug: COR-101;Drug: Placebo | Proportion of patients with Adverse Events of Special Interest (AESI);Proportion of patients with Serious Adverse Events (SAEs);Proportion of patients with Treatment-Emergent Adverse Events (TEAEs) | | | | Yes | False | | |
| → | NCT04708457 | 17 August 2021 | The REDEEM Pilot Study: A Feasibility RCT of Early ECMO in Severe Acute Respiratory Infection, Including COVID-19, WHO | A Pilot Feasibility RCT of Early ECMO to DE-sedate, Extubate, and Mobilise in Severe Acute Respiratory Infection | REDEEM | Australian and New Zealand Intensive Care Research Centre | 04/12/2020 | 20201204 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04708457 | Not recruiting | No | 18 Years | 70 Years | All | February 1, 2022 | 12 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor). | N/A | Germany;Australia;Germany;Australia→Australia;Germany;Australia;Germany | ; | Aidan Burrell, MBBS;Anne Mather | | ;anne.mather@monash.edu | ;99030151 | The Alfred; |
<br> Inclusion Criteria:
<br>
<br> 1. Laboratory confirmed severe acute respiratory infection (SARI) pneumonitis such as
<br> Coronavirus disease of 2019 (COVID-19) or influenza, AND
<br>
<br> 2. =5 days of mechanical ventilation, AND
<br>
<br> 3. Moderate to severe respiratory failure as shown by either the ratio of partial
<br> pressure of oxygen and the fracture of inspired oxygen (PaO2:FiO2 Rati)o <150 for >6
<br> hours OR the potential of hydrogen (pH) <7.30 with carbon dioxide (CO2) >50mmHg for 6
<br> hours, AND
<br>
<br> 4. Are unable to pass a spontaneous breathing trial.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Age =70 year old
<br>
<br> 2. Extubation likely in next 24-48 hours
<br>
<br> 3. Duration of mechanical ventilation =7days
<br>
<br> 4. =2 non-pulmonary organ failures (as scored by the sequential oxygen failure assessment
<br> (SOFA) score)
<br>
<br> 5. Need for immediate VV ECMO (as per EOLIA (research study) criteria*)
<br>
<br> 6. Requirement for VA ECMO
<br>
<br> 7. Clinical frailty or =2 major comorbidities
<br>
<br> 8. The physician deems the study is not in the patient's interest
<br>
<br> - EOLIA criteria (P:F <50 for 3 hours, P:F<80 for 6 hours, pH<7.25 with carbon
<br> dioxide partial pressure (PCO2) >60 for >6 hours
<br> | | Mechanical Ventilation Complication;Severe Acute Respiratory Infection;Covid19 | Other: VV-ECMO | Number of participants who have SARI and have been mechanically ventilated for at least 5 days. | | | | Yes | False | | |
| NCT04713553 | 17 August 2021 | A Phase 3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Production Lots and Dose Levels of BNT162b2 RNA-Based COVID-19 Vaccines Against COVID-19 in Healthy Participants | A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE PRODUCTION LOTS AND DOSE LEVELS OF THE VACCINE CANDIDATE BNT162b2 AGAINST COVID-19 IN HEALTHY PARTICIPANTS 12 THROUGH 50 YEARS OF AGE AND THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF BNT162b2 RNA-BASED COVID-19 VACCINE CANDIDATES AS A BOOSTER DOSE IN HEALTHY PARTICIPANTS 18 THROUGH 50 YEARS OF AGE | | BioNTech SE | 15/01/2021 | 20210115 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04713553 | Not recruiting | No | 12 Years | 50 Years | All | February 15, 2021 | 1530 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | United States | | Pfizer CT.gov Call Center | | | | Pfizer |
<br> Inclusion Criteria:
<br>
<br> - Primary study: Male or female participants between the ages of 12 and 50 years,
<br> inclusive, at randomization.
<br>
<br> - Booster study: Male or female participants between the ages of 18 and 50 years,
<br> inclusive, at rerandomization.
<br>
<br> - Participants who are willing and able to comply with all scheduled visits, treatment
<br> plan, laboratory tests, lifestyle considerations, and other study procedures.
<br>
<br> - Healthy participants who are determined by medical history, physical examination (if
<br> required), and clinical judgment of the investigator to be eligible for inclusion in
<br> the study.
<br>
<br> - Capable of giving personal signed informed consent/have parent(s)/legal guardian
<br> capable of giving signed informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Other medical or psychiatric condition including recent (within the past year) or
<br> active suicidal ideation/behavior or laboratory abnormality that may increase the risk
<br> of study participation or, in the investigator's judgment, make the participant
<br> inappropriate for the study.
<br>
<br> - Known infection with HIV, HCV, or HBV.
<br>
<br> - History of severe adverse reaction associated with a vaccine and/or severe allergic
<br> reaction (eg, anaphylaxis) to any component of the study intervention.
<br>
<br> - Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result
<br> was not available) or microbiological (based on COVID-19 symptoms/signs and a positive
<br> SARS-CoV-2 NAAT result) diagnosis of COVID 19.
<br>
<br> . Immunocompromised individuals with known or suspected immunodeficiency, as
<br> determined by history and/or laboratory/physical examination.
<br>
<br> - Bleeding diathesis or condition associated with prolonged bleeding that would, in the
<br> opinion of the investigator, contraindicate intramuscular injection.
<br>
<br> - Women who are pregnant or breastfeeding.
<br>
<br> - Primary study: Previous vaccination with any coronavirus vaccine.
<br>
<br> - Booster study: Previous vaccination with any coronavirus vaccine outside of this
<br> study.
<br>
<br> - Receipt of medications intended to prevent COVID-19.
<br>
<br> - Individuals who receive treatment with radiotherapy or immunosuppressive therapy,
<br> including cytotoxic agents or systemic corticosteroids, eg, for cancer or an
<br> autoimmune disease, or planned receipt throughout the study.
<br>
<br> - Receipt of blood/plasma products or immunoglobulin, from 60 days before study
<br> intervention administration or planned receipt throughout the study.
<br>
<br> - Participation in other studies involving study intervention within 28 days prior to
<br> study entry and/or during study participation.
<br>
<br> - Previous participation in other studies involving study intervention containing lipid
<br> nanoparticles.
<br>
<br> - Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct
<br> of the study, site staff otherwise supervised by the investigator, and their
<br> respective family members.
<br>
<br> Additional Exclusion Criteria for the Booster study:
<br>
<br> - Current febrile illness (body temperature =100.4°F [=38.0°C]) or other acute illness
<br> within 48 hours before study intervention administration.
<br>
<br> - Receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other
<br> nonstudy vaccine within 28 days, before or after study intervention administration.
<br>
<br> - Receipt of short-term (<14 days) systemic corticosteroids. Inhaled/nebulized,
<br> intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
<br> | | SARS-CoV-2 Infection;COVID-19 | Biological: BNT162b2;Biological: BNT162b2.B.1.351 | Percentages of participants with seroresponse (based on neutralizing titers) to the B.1.351 strain.;Percentages of participants with seroresponse (based on neutralizing titers) to the reference strain.;Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 full-length S-binding antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351).;Geometric Mean Fold Rise (GMFR) of SARS-CoV-2 reference strain and B.1.351 strain neutralizing antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351).;Geometric Mean IgG Concentrations (GMC) of SARS-CoV-2 full-length S-binding antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351).;Geometric Mean Titers (GMT) of SARS-CoV-2 reference strain and B.1.351 strain neutralizing antibody levels for Booster Arm 1 (BNT162b2) and Booster Arm 2 (BNT162b2.B.1.351).;Percentage of participants reporting serious adverse events;Percentage of participants reporting adverse events;Percentage of participants reporting systemic events;Percentage of participants reporting local reactions;GMR of SARS-CoV-2 neutralizing antibody levels between the 20-microgram dose group (Arm 5) and the corresponding 30-microgram dose group (Arm 1, 2, or 3) in participants without evidence of SARS-C0V-2 infection during the study.;GMR of SARS-CoV-2 full-length S-binding antibody levels between the EU lot (Arm 4) and pooled US lots (Arms 1, 2, and 3) in participants without evidence of infection during the study;Geometric Mean Ratio (GMR) of SARS-CoV-2 full-length S-binding antibody levels between US lots (Arms 1, 2 and 3) in participants without evidence of infection during the study | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2021-002612-31-IT | 17 August 2021 | Adaptive, randomized, placebo-controlled trial to evaluate the efficacy of monoclonal antibodies in outpatients with mild or moderate COVID-19 (MANTICO) | Adaptive, randomized, placebo-controlled trial to evaluate the efficacy of monoclonal antibodies in outpatients with mild or moderate COVID-19 (MANTICO) - Efficacy of monoclonal antibodies in outpatients with mild or moderate COVID-19 (MANTICO Trial) | | AZIENDA OSPEDALIERA UNIVERSITARIA INTEGRATA VERONA | 27/05/2021 | 20210527 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-002612-31 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 25/05/2021 | 1260 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: yes<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 3<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Italy | UOC Malattie Infettive | | P.le Ludovico Scuro, 10 | evelina.tacconelli@univr.it | 0458128245 | Azienda Ospedaliera Universitaria Integrata Verona | Inclusion criteria: <br>Participants are eligible to be included in the study only if all of the following general inclusion (GI) criteria apply:<br>• Age = 50 years<br>• Informed consent by the subject or legally authorized representative<br>• Laboratory-confirmed SARS-CoV-2 infection, as determined by PCR or other commercial or public health assay in any specimen, no more than 4 days prior to the study drug administration <br>• Peripheral oxygen saturation = 94% on room air and not requiring supplemental oxygen<br>• Onset of symptom is no more than 4 days prior to the study drug administration. Onset time of symptom is defined as the time when the patient experienced the presence of at least one of the following (but not limited to) SARS-CoV-2 infection-associated symptom (FDA, September 2020):<br>o Nasal obstruction or congestion<br>o Cough <br>o Fever >37.3 °C<br>o Sore throat<br>o Body pain or muscle pain <br>o Headache <br>o Loss of taste or smell <br>o Nausea or vomiting <br>o Diarrhoea<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 460<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 800<br> | Exclusion criteria: <br>• AIFA (Italian Medicine Agency) criteria for the use of monoclonal antibodies (the definitions of the criteria may change before the start of the study on the basis of new communications from AIFA for the definition of these criteria)<br>o Body Mass Index (BMI) =35<br>o Chronic kidney disease<br>o Uncontrolled diabetes<br>o Primary immunodeficiencies<br>o Secondary immunodeficiencies<br>o Cardio-cerebrovascular disease in the patient at least 55 years of age<br>o COPD and / or other chronic respiratory diseases in the patient at least 55 years of age<br>• Previously or currently hospitalized or requiring hospitalization <br>• Respiratory distress with respiratory rate = 25 breaths/min<br>• Heart rate = 125 beats per minute<br>• Peripheral oxygen saturation = 93% on room air at sea level<br>• Known allergies to any of the components used in the formulation of the interventions<br>• Hemodynamic instability requiring use of pressors within 24 hours of randomization<br>• Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that could potentially lead to hospitalization in within 30 days<br>• Any co-morbidity requiring surgery within 7 days or that is considered life-threatening within 90 days<br>• History of a positive SARS-CoV-2 serology test<br>• History of a positive SARS-CoV-2 test prior to the one serving as eligibility for this study<br>• Other investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing<br>• Previous treatment with a SARS-CoV-2 specific monoclonal antibody <br>• History of convalescent COVID-19 plasma treatment <br>• Previous SARS-CoV-2 vaccination<br>• Participation, within the last 30 days, in a clinical study involving an investigational intervention<br>• Pregnancy or breast feeding<br>• Investigator site personnel directly affiliated with this study<br>• Sexually active women of childbearing potential or sexually active men who are unwilling to practice effective contraception prior to the initial dose/start of the first treatment, during the study, and for at least 6 months after the last dose<br>• Inability to participate to the study follow-up.<br> | COVID-19 <br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: .<br>Product Name: Bamlanivimab<br>Product Code: [Bamlanivimab]<br>Pharmaceutical Form: Concentrate for solution for injection/infusion<br>INN or Proposed INN: Bamlanivimab<br>CAS Number: 2423943-37-5<br>Current Sponsor code: Bamlanivimab<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 700-<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br>Trade Name: .<br>Product Name: CASIRIVIMAB/IMDEVIMAB<br>Product Code: [CASIRIVIMAB/IMDEVIMAB]<br>Pharmaceutical Form: Concentrate for solution for injection/infusion<br>INN or Proposed INN: Casirivimab e imdevimab<br>Current Sponsor code: Casirivimab/imdevimab<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 120-<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br>Trade Name: .<br>Product Name: ETESEVIMAB<br>Product Code: [ETESEVIMAB]<br>Pharmaceutical Form: Concentrate for solution for injection/infusion<br>INN or Proposed INN: Etesevimab<br>CAS Number: 2423948-94-9<br>Current Sponsor code: Etesevimab<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 700-<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br> | Timepoint(s) of evaluation of this end point: Within 14 days of randomization;Primary end point(s): COVID-19 disease progression, defined as (1) hospitalization or (2) need for supplemental oxygen therapy at home or (3) death, within 14 days of randomization;Secondary Objective: Secondary objetives of the study are the following:<br>- To compare the efficacy of experimental treatments versus placebo with respect to other relevant clinical endpoints.<br>- To compare the effectiveness of experimental treatments compared to placebo with regard to laboratory endpoints.<br>- To compare the efficacy of experimental treatments versus placebo with regard to negative result of the nasopharyngeal swab for the detection of SARS-CoV-2.<br>- To compare the efficacy of experimental treatments versus placebo with respect to patient-reported endpoints.;Main Objective: This study is a phase 3, multicentre, randomized, adaptive trial to investigate the efficacy of bamlanivimab / etesevimab (700 mg / 1400 mg) and casirivimab / imdevimab (1200 mg / 1200 mg) given at an early stage. (within 4 days of onset of symptoms) of COVID-19 (symptomatic stage without the need for oxygen supplementation or hospitalization) in preventing disease progression (need for oxygen therapy supplementation and / or hospitalization and / or death) in patients over 50 years of age not included in the administration criteria indicated by AIFA. | | | | No | False | | |
| → | EUCTR2021-000344-21-ES | 17 August 2021 | MP1032 Treatment in Patients with Moderate to Severe COVID-19 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, PROOF-OF-CONCEPT, PHASE IIA STUDY OF MP1032 PLUS STANDARD OF CARE VS STANDARD OF CARE IN THE TREATMENT OF HOSPITALIZED PATIENTS WITH MODERATE TO SEVERE COVID-19. - MP1032 Treatment in Patients with Moderate to Severe COVID-19 | | MetrioPharm AG | 11/06/2021 | 20210611 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000344-21 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 10/08/2021 | 120 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>Other trial design description: Proof of concept<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Italy;Bulgaria;Romania;Spain;Belgium;Poland;Mexico;Hungary;Czechia;United States;France | Clinical Department | | Am Borsigturm 100 | clinicaltrials@metriopharm.com | +4930 338439502 | MetrioPharm Deutschland GmbH | Inclusion criteria: <br>1. The patient must be willing and able to give informed consent to participate in the study and to adhere to the procedures stated in the protocol or, for adults incapable of consenting due to their medical condition (eg, too weak or debilitated, severe shortness of breath) or due to literacy issues, the patient’s legally authorized representative must be willing and able to give informed consent on behalf of the patient to participate in the study as permitted by local regulatory authorities, institutional review boards (IRBs)/independent ethics committees (IECs), or local laws;<br>2. The patient is male or female adult aged =18 years (as per local laws) at the time of giving informed consent;<br>3. The patient is admitted to a hospital and has a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test. Please note: If the patient has a previous confirmation of SARS-CoV-2 (within 7 days of Day 1), the SARS-CoV-2 test at screening is not required;<br>4. The patient has the presence of any symptom(s) suggestive of moderate or severe systemic illness with COVID-19 on Day 1, such as presence of fever (=38.0°C [=100.4°F] by any route), loss of smell or taste, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, shortness of breath upon exertion and/or at rest, or respiratory distress;<br>5. The patient has the presence of moderate to severe clinical signs indicative of moderate or severe illness with COVID-19 on Day 1:<br>a) Moderate:<br>i. Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate =20 breaths per minute, SpO2 >93% (on room air at sea level, if possible), heart rate =90 beats per minute<br>ii. No clinical signs indicative of severe or critical COVID-19<br>b) Severe:<br>i. Clinical signs suggestive of severe systemic illness with COVID-19, such as respiratory rate =30 breaths per minute, heart rate =125 beats per minute, SpO2 =93% (on room air at sea level, if possible), partial pressure of oxygen/FiO2 <300, or diagnosed with acute respiratory distress syndrome (according to the Berlin definition)<br>ii. No criteria met for critical COVID-19<br>6. The patient does not require hemodialysis (chronic) or any renal replacement therapies at screening or Day 1;<br>7. The patient is able to swallow the study drug (hard gelatin capsules);<br>8. The patient agrees to minimize strong sun exposure (sunbathing) and strong ultraviolet exposure during the course of the study. Additionally, during the study, patients must agree to use sunscreen when spending an extended period outdoors;<br>9. Men whose sexual partners are women of childbearing potential (WOCBP) must agree to comply with 1 of the following contraception requirements from the time of first dose of study medication (Day 1) until at least 30 days after the last dose of study medication:<br>a) Vasectomy with documentation of azoospermia.<br>b) Sexual abstinence (defined as refraining from heterosexual intercourse from the time of first dose of study medication until at least 30 days after the last dose of study medication)<br>c) Male condom plus partner use of 1 of the contraceptive options below: contraceptive subdermal implant; intrauterine device or intrauterine system; oral contraceptive, either combined or progestogen alone; injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches.<br>10. WOCBP must agree to comply with 1 of the following contraception requirements from the time of first dose of study medication (Day 1) until at l | Exclusion criteria: <br>1. The patient, in the opinion of the investigator, is not likely to survive for =48 hours beyond Day 1.<br>2. The patient has a diagnosis of asymptomatic COVID-19, mild COVID-19, or critical COVID-19 on Day 1.<br>a) Asymptomatic COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test but not experiencing symptoms.<br>b) Mild COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing symptoms of mild illness but no clinical signs indicative of moderate, severe, or critical COVID-19.<br>c) Critical COVID-19 is defined as a patient with a positive SARS-CoV-2 test by standard RT-PCR assay or equivalent test and experiencing at least 1 of the following: shock defined by systolic blood pressure <90 mm Hg or diastolic blood pressure <60 mm Hg, or requiring vasopressors; respiratory failure requiring endotracheal intubation and invasive mechanical ventilation, oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered via reinforced nasal cannula at flow rates >20 L/min with fraction of delivered oxygen =0.5), non-invasive positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (ie, clinical need for 1 of the preceding therapies, but preceding therapies not able to be administered in setting of resource limitation), and/or multi-organ dysfunction/failure.<br>3. The patient has a Child Pugh score = C.<br>4. The patient has a documented medical history of infection with hepatitis A, B, or C at screening or Day 1.<br>5. The patient has a documented medical history of infection with human immunodeficiency virus and has a detectable viral load and CD4 count <500 cells/µL.<br>6. The patient has a documented active infection with tuberculosis at screening or Day 1.<br>7. The patient has clinically significant electrocardiogram abnormalities at screening.<br>8. A female patient who is pregnant, planning to become pregnant during the study, breastfeeding, or has a positive pregnancy test at screening (by serum) and before dosing on Day 1 (by urine) as determined by human chorionic gonadotrophin tests.<br>9. The patient is planning to donate or bank ova or sperm from Day 1 until 30 days after the last dose of study drug.<br>10. The patient has a known history of drug or alcohol abuse within 6 months of study start that would interfere with the patient’s participation in the study.<br>11. The patient has a history of sensitivity to any of the study medications, components thereof (eg, mannitol or gelatin), or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, would contraindicate their participation.<br>12. The patient has participated in and/or plans to participate in another clinical study using an investigational product within the following period before the first dosing day in the current study: 30 days, 5 half-lives, or twice the duration of the biological effect of the investigational product (whichever is longer).<br>13. The patient will be transferred to another hospital that is not a study site within 72 hours. Please note: If the investigator has admitting privileges to the transfer hospital, the patient may be considered for randomization.<br>14. The patient is employed by MetrioPharm, the contract research organization or clinical site involved in the clinical study.<br>15. The investigator makes a decision that study involvement is not in patient’s best interest, or the patient h | Moderate to severe coronavirus disease 2019 (COVID 19) <br>MedDRA version: 23.1
Level: LLT
Classification code 10084401
Term: COVID-19 respiratory infection
System Organ Class: 100000004862
<br>MedDRA version: 23.1
Level: PT
Classification code 10084460
Term: COVID-19 treatment
System Organ Class: 10042613 - Surgical and medical procedures
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084382
Term: Coronavirus disease 2019
System Organ Class: 100000004862
<br>MedDRA version: 23.1
Level: LLT
Classification code 10084529
Term: 2019 novel coronavirus infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: MP1032 hard gelatin capsules 50 mg<br>Product Code: MP1032<br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: N/A<br>CAS Number: 20666-12-0<br>Current Sponsor code: MP1032<br>Other descriptive name: MP 1032<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 50-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br> | Main Objective: The primary objective of this study is to measure the effect of MP1032 plus standard of care (SoC) versus placebo plus SoC on Day 14 on disease progression in patients with moderate to severe coronavirus disease 2019 (COVID-19);Timepoint(s) of evaluation of this end point: Day 14;Primary end point(s): The primary efficacy endpoint of this study is the proportion of patients with disease progression on Day 14. Disease progression is defined as the proportion of patients who are not alive or who have respiratory failure. Respiratory failure is defined as patients who have a score of 2, 3, or 4 on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale.;Secondary Objective: The secondary objectives of this study are:<br><br>• To measure the effect of MP1032 plus SoC versus placebo plus SoC on Day 28 on disease progression in patients with moderate to severe COVID-19;<br>• To measure the effect of MP1032 plus SoC versus placebo plus SoC on disease resolution on Day 14 and Day 28;<br>• To measure the effect of MP1032 plus SoC versus placebo plus SoC on the mortality rate and other specific COVID-19 related characteristics;<br>• To assess the safety of MP1032 (eg, adverse events [AEs] and laboratory abnormalities);<br>• To assess the pharmacokinetics (PK) of MP1032 on Day 1 (single dose) and Day 7 (steady state) in a PK subset of patients. <br><br>The exploratory objectives of this study are:<br><br>• To measure the effect of MP1032 plus SoC versus placebo plus SoC on some additional COVID-19 related characteristics;<br>• To evaluate the health-related quality of life (HRQoL) of patients treated MP1032 plus SoC compared with placebo plus SoC;<br>• To evaluate biomarker levels.→Primary end point(s): The primary efficacy endpoint of this study is the proportion of patients with disease progression on Day 14. Disease progression is defined as the proportion of patients who are not alive or who have respiratory failure. Respiratory failure is defined as patients who have a score of 2, 3, or 4 on the National Institute of Allergy and Infectious Diseases (NIAID) 8-point ordinal scale.;Secondary Objective: The secondary objectives of this study are:<br><br>• To measure the effect of MP1032 plus SoC versus placebo plus SoC on Day 28 on disease progression in patients with moderate to severe COVID-19;<br>• To measure the effect of MP1032 plus SoC versus placebo plus SoC on disease resolution on Day 14 and Day 28;<br>• To measure the effect of MP1032 plus SoC versus placebo plus SoC on the mortality rate and other specific COVID-19 related characteristics;<br>• To assess the safety of MP1032 (eg, adverse events [AEs] and laboratory abnormalities);<br>• To assess the pharmacokinetics (PK) of MP1032 on Day 1 (single dose) and Day 7 (steady state) in a PK subset of patients. <br><br>The exploratory objectives of this study are:<br><br>• To measure the effect of MP1032 plus SoC versus placebo plus SoC on some additional COVID-19 related characteristics;<br>• To evaluate the health-related quality of life (HRQoL) of patients treated MP1032 plus SoC compared with placebo plus SoC;<br>• To evaluate biomarker levels.;Timepoint(s) of evaluation of this end point: Day 14;Main Objective: The primary objective of this study is to measure the effect of MP1032 plus standard of care (SoC) versus placebo plus SoC on Day 14 on disease progression in patients with moderate to severe coronavirus disease 2019 (COVID-19) | | | | Yes | True | parent | |
| → | EUCTR2021-001411-82-ES | 17 August 2021 | A phase I study to evaluate safety and immunogenicity of recombinant protein candidate vaccine against SARS-CoV-2 in healthy volunteers. | A phase I/IIa study to evaluate safety and immunogenicity of recombinant protein RBD fusion dimer candidate vaccine against SARS-CoV-2 in adult healthy volunteers. | | LABORATORIOS HIPRA, S.A. | 22/06/2021 | 20210622 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-001411-82 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 11/08/2021 | 30 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: yes<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Spain | R&D and Regulatory Affairs Director | | Avda La Selva, 135 | elia.torroella@hipra.com | +34972430660 | LABORATORIOS HIPRA, S.A. | Inclusion criteria: <br>1. Adults males or females between 18-39 years of age at the day of screening.<br>2. Willing and able to comply with scheduled visits, laboratory test, complete diaries and other study procedures.<br>3. Body Mass Index 18 to 40 Kg/m2 at screening.<br>4. COVID19 negative PCR test and negative serum IgG binding antibody response to the SARS-CoV-2 S glycoprotein at screening or prior the first vaccination.<br>5. Willing to avoid all other vaccines within 4 weeks before and after each injection. Seasonal influenza vaccination is allowed if it is received at least 14 days before or after the vaccination.<br>6. Women of childbearing potential must have a negative pregnancy test in urine before the inclusion of the study and prior to each vaccination.<br>7. If female of childbearing potential, willing to use highly effective contraceptive methods or have practiced sexual abstinence from the screening visit until 8 weeks after the last injection. Highly effective contraceptive methods will include: oral, intravaginal or transdermal combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, injectable or implantable progestogen-only hormonal contraception associated with inhibition of ovulation; intrauterine device; intrauterine hormone-releasing system; bilateral tubal occlusion; vasectomized partner and sexual abstinence.<br>8. If male and not sterilized, willing to avoid impregnating female partners from screening until 18 weeks after last injection.<br>9. Willing and able to provide written informed consent prior the initiation of any study procedures.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 30<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>1. Pregnant or lactating or intending to become pregnant or plans to breastfeed during the study.<br>2. Positive pregnancy test at screening or prior to each vaccination.<br>3. Any medical disease (acute, subacute, intermittent or chronic) or condition that in the opinion of the investigator compromise the volunteer's safety, preclude vaccination or compromise interpretation of the results.<br>4. History of serious psychiatric condition likely to affect participation in the study (e-g- ongoing severe depression, history of admission to an in-patient psychiatric facility, recent suicidal ideation, history of suicide attempt, bipolar disorder, personality disorder, alcohol and drug dependency, severe eating disorder, psychosis, use of mood stabilisers or antipsychotic medication).<br>5. History of respiratory disease (e.g., chronic obstructive pulmonary disease (COPD) and asthma) requiring any daily medications currently or any treatment of respiratory disease exacerbations (e.g., asthma exacerbation) in the last 5 years.<br>6. History of significant cardiovascular disease including hypertension (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis as an adult.<br>7. History of neurological or neurodevelopmental conditions (e.g., migraines, epilepsy, stroke, seizures in the last 3 years, encephalopathy, focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis).<br>8. Ongoing malignancy or recent diagnosis of malignancy in the last five years excluding basal cell and squamous cell carcinoma of the skin, which are allowed.<br>9. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections.<br>10. Any autoimmune or immunodeficiency disease/condition (iatrogenic or congenital).<br>NOTE: Mild psoriasis, well controlled autoimmune thyroid disease, vitiligo, stable coeliac disease not requiring immunosuppressive or immunomodulatory therapy and any stable endocrine disorders that have a confirmed autoimmune aetiology (e.g., thyroid, pancreatic), including stable diet-controlled diabetes will be permitted at the discretion of the investigator.<br>11. Acute illness within 72 hours prior each vaccination that in the opinion of the investigator may interfere the evaluation of safety parameters.<br>12. Usage of any investigational drug = 90 days prior to study entry or plan to participate in another research involving an investigational product (drug/biologic/device) within 12 months after the first study vaccination.<br>13. History of hypersensitivity or severe allergic reaction including anaphylaxis, generalized urticarial, angioedema and other significant reactions related to food, drugs, vaccines or pharmaceutical agents.<br>14. History of allergic disease or reactions likely to be exacerbated by any component of the COVID-19 vaccine HIPRA (including the oil in water adjuvant equivalent to MF59).<br>15. Use of any immunosuppressant, glucocorticoids, or other immune-modifying drugs within 2 months prior to first study vaccination; or anticipation of the need for immunosuppressive treatment within 6 months after last vaccination.<br>NOTE: The use of topical, inhaled, and nasal routes are not permitted.<br>16. Received immunoglobulin, blood-derived products, or other immunosuppressant drugs within 90 days prior to first study vaccination.<br>17. Known disturbance of coagulation (iatrogenic or congenital) or blood dyscrasias.<br>18. Known | SARS-CoV-2 <br>MedDRA version: 23.0
Level: LLT
Classification code 10084272
Term: SARS-CoV-2 infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: PHH-1V<br>Pharmaceutical Form: Emulsion for injection<br>INN or Proposed INN: PHH-1V<br>Other descriptive name: PHH-1V<br>Concentration unit: µg microgram(s)<br>Concentration type: range<br>Concentration number: 10-40<br><br>Trade Name: Comirnaty<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: BNT162b2SA<br>Other descriptive name: BNT162b2SA<br>Concentration unit: ml millilitre(s)<br>Concentration type: equal<br>Concentration number: 0.3-<br><br> | Timepoint(s) of evaluation of this end point: 7 and 28 days;Primary end point(s): 1.1 Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination.<br>1.2 Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination.<br>Local solicited reactions will be collected as pain, tenderness, erythema/redness, and induration/swelling.<br>Systemic solicited events will be collected as fever, nausea/vomiting, diarrhoea, headache, fatigue and myalgia;Secondary Objective: 1.Overall safety of COVID-19 HIPRA vaccine.<br>2.Immunogenicity measured by wild-type and pseudovirus neutralization at baseline and 3-weeks after the first dose and 2-weeks after the second dose of vaccine.<br>3.Immunogenicity measured by wild-type and pseudovirus neutralization at long-term, i.e. 24 and 48 weeks after the second dose of vaccine.<br>4.Immunogenicity measured by enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 spike glycoprotein at baseline and 3-weeks after the first dose and 2-weeks after the second dose of vaccine.<br>5.Immunogenicity measured by enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 spike glycoprotein at long-term, i.e. 24 and 48 weeks after the second dose of vaccine.<br>6.T-cell mediated responses against the SARS-CoV-2 S glycoprotein at baseline and 2-weeks after the second dose of vaccine.<br>7.Th-1/Th-2 T-cell mediated responses against the SARS-CoV-2 S glycoprotein at baseline and 2-weeks after the second dose of vaccine.;Main Objective: To assess safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers. Safety will be measured by solicited and unsolicited reactions (local and systemic) following each dose vaccination.→Timepoint(s) of evaluation of this end point: 7 and 28 days;Primary end point(s): 1.1 Number and percentage of solicited local and systemic reactogenicity adverse events for 7 days following each vaccination.<br>1.2 Number and percentage of unsolicited local and systemic reactogenicity adverse events for 28 days following each vaccination.<br>Local solicited reactions will be collected as pain, tenderness, erythema/redness, and induration/swelling.<br>Systemic solicited events will be collected as fever, nausea/vomiting, diarrhoea, headache, fatigue and myalgia;Main Objective: To assess safety and tolerability of COVID-19 HIPRA vaccine in healthy adult volunteers. Safety will be measured by solicited and unsolicited reactions (local and systemic) following each dose vaccination.;Secondary Objective: 1.Overall safety of COVID-19 HIPRA vaccine.<br>2.Immunogenicity measured by wild-type and pseudovirus neutralization at baseline and 3-weeks after the first dose and 2-weeks after the second dose of vaccine.<br>3.Immunogenicity measured by wild-type and pseudovirus neutralization at long-term, i.e. 24 and 48 weeks after the second dose of vaccine.<br>4.Immunogenicity measured by enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 spike glycoprotein at baseline and 3-weeks after the first dose and 2-weeks after the second dose of vaccine.<br>5.Immunogenicity measured by enzyme-linked immunosorbent assay (ELISA) to the SARS-CoV-2 spike glycoprotein at long-term, i.e. 24 and 48 weeks after the second dose of vaccine.<br>6.T-cell mediated responses against the SARS-CoV-2 S glycoprotein at baseline and 2-weeks after the second dose of vaccine.<br>7.Th-1/Th-2 T-cell mediated responses against the SARS-CoV-2 S glycoprotein at baseline and 2-weeks after the second dose of vaccine. | | | | Yes | False | | |
| EUCTR2021-001357-31-NL | 17 August 2021 | Study of the immune response after corona vaccination | Immune Responses Induced by Vaccination Against COVID-19 in Dutch healthy subjects - IIVAC | | National Institute of Health and the Environment | 20/04/2021 | 20210420 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-001357-31 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 03/05/2021 | 2100 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>Other trial design description: the trial follows the different SARS-CoV-2 immunizations given by the Government.<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 4<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Netherlands | IIVAC studyteam | | Antonie van Leeuwenhoeklaan 9 | IIVAC@rivm.nl | | National Institute of Health and the Environment | Inclusion criteria: <br>• Be 0 – 60 years at the time of inclusion<br>• Be capacitated mentally and physically<br>• Be willing to receive SARS-CoV-2 vaccine <br>• Having signed the Informed Consent<br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: 300<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 1800<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>•Participation in a phase I/II/III vaccination trial where the subject will be vaccinated with a pre-registration (COVID-19) vaccine<br>•Participation in a phase I/II/III medicine (pre-registration) trial <br>•Belonging to a risk group for COVID-19 that is studied in one of the ZonMw-funded risk group vaccination studies (details of risk group studies provided in protocol ref. [9,10,11]) that this study provides a comparison for:<br>oPrimary (inherited) immune deficiency (VACOPID study)<br>oSeverely decreased kidney function (defined as Chronic Kidney Disease stage 4 or 5 (eGFR<30)), treatment by dialysis or recipient of a kidney transplant (RECOVAC study)<br>oPulmonary disease for which the patient will receive or has received a lung transplant (COVALENT study)<br>oAutoimmune disease (e.g. MS, rheumatoid arthritis, IBD, SLE etc) (Target to B! (sub)study)<br>oDown syndrome (PRIDE study)<br>o(Known) infection with Human Immunodeficiency Virus (HIV) (COVIH study)<br>oCancer patients and patients with active cancer treatment (including hormone therapy), receipt of chemotherapy in the last 3 years and/or any history of cancer immune therapy (VOICE study) <br>oHaematological patients, such as haematological malignancies (leukemia and lymphomas), myelodysplastic and -proliferative syndromes, hemoglobinopathies (sickle cell disease and thalassemia), receipt of stem cell transplantation or cell therapy such as CAR T-cell therapy (COBRA-KAI study)<br>•Any other immune deficiency through disease<br>•Active or past immunosuppressive or immune modulating medication. <br>However, for steroid treatment the exclusion criteria are: receipt of any high-dose (= 20 mg of prednisone daily or equivalent) steroid treatment; daily corticosteroids (locally, incl. inhaled steroids, are acceptable) within 2 weeks of study entry; or repeated use of any high dose of corticosteroids (a dose of > 30 mg of prednisone or equivalent per day for multiple days) in the recent past.<br>•Women who are pregnant or breastfeeding<br>•Having a (functional) asplenia<br>•Receipt of blood products or immunoglobulin, within 3 months of study entry<br>•Receipt of an organ transplant not mentioned above <br>•For the subgroup: Known or suspected coagulation disorder, also by treatment, that would contraindicate undergoing frequent blood sampling<br> | Immune Responses Induced by Vaccination Against COVID-19 in Dutch healthy subjects;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Pharmaceutical Form: Suspension for injection<br><br> | Timepoint(s) of evaluation of this end point: day 28 after completion of vaccination(s);Primary end point(s): COVID-19 vaccine (e.g. Spike protein)-specific serum IgG (GMC) in Dutch healthy subjects, at day 28 after completion of COVID-19 vaccination, by bead-based multiplex immune assay (MIA). ;Main Objective: Monitoring & evaluation of immune responses induced by COVID-19 vaccines in the general population in the Netherlands, specifically vaccine (e.g. Spike protein)-specific serum IgG GMC at day 28 after completion of COVID-19 vaccination by multiplex immune assay (MIA).;Secondary Objective: a. Measuring humoral, cellular and innate COVID-19 vaccine-induced immune responses <br>b. Measuring virus neutralizing capacity of antibodies induced by COVID-19 vaccination <br>c. Measuring Fc functionality of antibodies (e.g. complement deposition) and antibody glycosylation status induced by COVID-19 vaccination <br>d. Measuring COVID-19 vaccine-induced antibodies in nasal mucosal lining fluid <br>e. Measuring reactogenicity self-reported in questionnaires shortly after vaccination | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04632602 | 24 August 2021 | Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure | Awake Prone Position to Reduce Ventilation Inhomogeneity in COVID-19 Acute Respiratory Failure: a Randomized Cross Over Electrical Impedance Tomography Study | ProneSpontCov | Assistance Publique Hopitaux De Marseille | 16/11/2020 | 20201116 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04632602 | Not recruiting | No | 18 Years | N/A | All | April 14, 2020 | 20 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Single (Participant). | N/A | France | | Jean-Olivier ARNAUD | | | | ASSISTANCE PUBLIQUE HÔPITAUX DE MARSEILLE |
<br> Inclusion Criteria:
<br>
<br> - more than 18 Years (Adult, Older Adult)
<br>
<br> - Confirmed COVID-19 (positive SARS-CoV-2 RT-PCR at nasopharyngeal swab)
<br>
<br> - Acute respiratory failure with 100 < PaO2:FiO2< 300 mmhg
<br>
<br> - Spontaneous ventilation with standard oxygen supply or high flow humidified oxygen
<br>
<br> - Written informed consent of the patient
<br>
<br> Exclusion Criteria:
<br>
<br> - Contra-indication to prone position including pregnancy
<br>
<br> - Presence of pacemaker
<br>
<br> - Severe hypoxemia with PaO2/FiO2 < 100 mmHg
<br>
<br> - Evidence of clinical signs of respiratory distress with high probability of intubation
<br> in the next two hours
<br> | | Respiratory Failure | Other: physiological effects of awake prone position in COVID 19 patients | Global Inhomogeneity Index variations (expressed in percentage) between baseline, supine and prone position periods. | | | | Yes | False | | |
| → | NCT04641806 | 24 August 2021 | Clinical and Immunological Evolution of Covid-19 Occurring in a Context of Non-Hodgkin Lymphoma | Clinical and Immunological Evolution of Covid-19 Occurring in a Context of Non-Hodgkin Lymphoma | LYMPHO-Cov-2 | Versailles Hospital | 20/11/2020 | 20201120 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04641806 | Not recruiting | No | 18 Years | N/A | All | November 1, 2020 | 0 | Observational | | | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - adults aged at least 18 years
<br>
<br> - Covid-19 confirmed by PCR
<br>
<br> - between February and May 2020
<br>
<br> - affiliated with a social security
<br>
<br> - consenting to the study
<br>
<br> Case specific inclusion criteria :
<br>
<br> - being or having been affected by B-NHL
<br>
<br> - being currently in remission, active surveillance or during first-line or second-line
<br> treatment
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects less than 18 years old
<br>
<br> - Subject with protective measure (curatorship, guardianship, safeguard of justice)
<br> -Subjects unable to give consent
<br>
<br> - Pregnant or breastfeeding women
<br>
<br> - Subject refusing to participate
<br>
<br> - Case-specific non-inclusion criteria :
<br>
<br> - Patient with a life expectancy linked to NHLof less than 6 months or with a History of
<br> hematopoietic allogeneic stem cell transplant
<br> | | B-cell Lymphoma;Covid19 | | Clinical evolution after Covid-19 diagnosis;Immunological response to SARS Cov2→Immunological response to SARS Cov2;Clinical evolution after Covid-19 diagnosis | | | | Yes | False | | |
| NCT04646603 | 24 August 2021 | MRG-001 as an Immunoregulatory and Regenerative Therapy for COVID-19 Patients | A Combined Phase I Double-blind Randomized Placebo-controlled Study in Healthy Subjects/Phase II, Randomized, Double-blind, Placebo-Controlled, Multi-center Study in Hospitalized Patients Infected With Severe and Critical SARS-CoV-2 to Assess the Safety, Pharmacokinetics, Pharmacodynamics and Efficacy of MRG-001 (Plerixafor Plus Low-dose Tacrolimus) | | MedRegen LLC | 24/11/2020 | 20201124 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04646603 | Not recruiting | No | 18 Years | 45 Years | All | January 28, 2021 | 18 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 1/Phase 2 | United States | | George Atiee, MD | | | | ICON plc |
<br> Inclusion Criteria:
<br>
<br> 1. Subject voluntarily agrees to participate in this study and signs an Institutional
<br> Review Board (IRB)-approved informed consent prior to performing any of the Screening
<br> Visit procedures.
<br>
<br> 2. Males and females between 18 to 45 years of age, inclusive, at the time of signing the
<br> ICF.
<br>
<br> 3. Subjects who test negative for SARS-CoV-2 by real time transcription polymerase chain
<br> reaction in the respiratory tract (nasopharyngeal [NP] swab) within the previous 96
<br> hours.
<br>
<br> 4. Nonsmokers (or other nicotine use) as determined by history (no nicotine use over the
<br> past 6 months) and by urine cotinine concentration (< 500 ng/mL) at the Screening
<br> Visit and admission.
<br>
<br> 5. Generally, in good health with no clinically significant abnormalities as determined
<br> by medical history, physical examination, 12-lead ECG and clinical laboratory tests.
<br>
<br> 6. The following applies to female subjects:
<br>
<br> •Non-pregnant, non-lactating females of childbearing potential who agree to use
<br> medically acceptable forms of birth control (hormonal contraception, abstinence,
<br> diaphragm with spermicide, condom with spermicide or intrauterine device) from the
<br> Screening Visit until the End-of-study Visit.
<br>
<br> 7. Body mass index (BMI) between 18.8 and 29.9 kg/m2, inclusive, at the Screening Visit.
<br>
<br> 8. A fasting blood glucose level =125 mg/dL (6.9 mmol/L), at the Screening Visit.
<br>
<br> Exclusion Criteria (Part A):
<br>
<br> 1. Participation in any other clinical trial of an experimental treatment for COVID-19
<br> (remdesivir and convalescent plasma use is permitted).
<br>
<br> 2. Subject has clinically significant history or evidence of cardiovascular, respiratory,
<br> hepatic, renal, gastrointestinal, endocrine, neurological, immunological or
<br> psychiatric disorder(s) as determined by the PI or designee.
<br>
<br> 3. Concurrent treatment with other agents with actual or possible direct acting
<br> immunomodulatory activity against ARDS in COVID-19 is prohibited <72 hours prior to
<br> study drug dosing [IL-6 inhibitors such as sarilumab and tocilizumab; IL-1ß blocker;
<br> and the JAK1/JAK2 inhibitor ruxolitinib, barcitinib and tofacitinib; complement
<br> inhibitor ravulizumab-cwvz; Bruton's tyrosine kinase inhibitor acalabrutinib, and
<br> macrophage migration inhibitor ibudilast].
<br>
<br> 4. History of splenomegaly (spleen weighing >750 g).
<br>
<br> 5. History of cancer or thrombocytopenia (platelet count <100,000/µL) or thrombocythemia
<br> (platelet count >500,000/µL).
<br>
<br> 6. Known family history of long QT syndrome (Torsades de Pointes) or currently taking
<br> medication that prolongs QT interval.
<br>
<br> 7. Currently taking immunomodulating biologics (e.g, interferons, interleukin).
<br>
<br> 8. Female subjects who are pregnant or breastfeeding or planning to breastfeed at any
<br> time through 90 days after last dose of study drug.
<br>
<br> 9. Any disorder that would interfere with the absorption, distribution, metabolism or
<br> excretion of drugs.
<br>
<br> 10. Received a vaccination (including influenza) administered 30 days or less prior to
<br> first treatment/randomization or has any planned vaccinations during the treatment
<br> period.
<br>
<br> 11. Creatinine clearance <50 mL/min using the Cockcroft-Gault formula.
<br>
<br> 12. Has the following liver function levels:
<br>
<br> Serum ALP or BIL >1.5 ULN or ALT or AST >ULN (Part A); Serum ALP or BIL >3.0 ULN or
<br> ALT or AST >5.0x ULN (Part B); at either screening or admission. Only 1 repeat
<br> assessment is allowed on each occasion.
<br>
<br> 13. History of alcohol and/or illicit drug abuse within 2 years of entry.
<br>
<br> 14. Positive test for Hepatitis B surface antigen (HBsAg), Hepatitis C antibody, or HIV
<br> antibody.
<br>
<br> 15. Has a positive blood test for ethanol at the Screening Visit or admission.
<br>
<br> 16. Has a positive urine drug test (e.g., cocaine, amphetamines, barbiturates, opiates,
<br> benzodiazepines, cannabinoids) at the Screening Visit or admission.
<br>
<br> 17. Has donated blood (>500 mL) or blood products within 2 months (56 days) prior to
<br> admission.
<br>
<br> 18. Has used an investigational drug within 30 days prior to Screening.
<br>
<br> 19. History of hypersensitivity to MRG-001 (plerixafor [AMD3100, 24 mg/mL]) and tacrolimus
<br> [FK506, 0.5 mg/mL]) or any of the excipients or to medicinal products with similar
<br> chemical structures.
<br>
<br> 20. Unable to understand the protocol requirements, instructions and study related
<br> restrictions, the nature, scope and possible consequences of the clinical study.
<br>
<br> 21. Unlikely to comply with the protocol requirements, instructions and study related
<br> restrictions; e.g., uncooperative attitude, inability to return for follow-up visits
<br> and improbability of completing the clinical study.
<br>
<br> 22. Previously been enrolled in this clinical study.
<br>
<br> 23. Vulnerable subjects defined as individuals whose willingness to volunteer in a
<br> clinical study may be unduly influenced by the expectation, whether justified or not,
<br> of benefits associated with participation, or of a retaliatory response from senior
<br> members of a hierarchy in case of refusal to participate (e.g., persons in detention,
<br> minors and those incapable of giving consent).
<br>
<br> 24. Laboratory-confirmation of SARS-CoV-2 by real time polymerase chain reaction in the
<br> respiratory tract (NP swab, tracheal aspirate, BAL) =96 hours prior to randomization.
<br>
<br> 25. Is unwilling to avoid use of alcohol or alcohol-containing foods, medications or
<br> beverages, within 48 hours prior to screening until discharge from the clinical site.
<br>
<br> 26. Is unable to abstain from smoking (or other nicotine use) from screening until
<br> discharge from the clinical site.
<br>
<br> 27. Has any concurrent disease or condition that, in the opinion of the PI, would make the
<br> subject unsuitable for participation in the clinical study such as:
<br>
<br> 1. Skin condition or disease (e.g., Stevens-Johnson syndrome).
<br>
<br> 2. Hypertension defined as >140 mmHg systolic blood pressure and >95 mmHg diastolic
<br> blood pressure.
<br>
<br> 3. High blood potassium (hyperkalemia) defined baseline serum potassium >5.0 to 5.5
<br> mEq/L (milliequivalent).
<br>
<br> 4. Torsades de Pointes or currently taking medication that prolongs QT interval.
<br>
<br> 5. Hematologic disorder (e.g. anemia or leukemia).
<br>
<br> 6. Type I or Type 2 diabetes mellitus defined as a fasting blood glucose level >126
<br> mg/dL (7.0 mmol/L).
<br>
<br> Inclusion Criteria (Part B)
<br>
<br> 1. Subject voluntarily agrees to participate in this study and is able to provide written
<br> informed consent, or has a legal representative who can provide informed consent or is
<br> enrolled unde | | COVID-19 | Drug: MRG-001;Drug: Placebo | Phase IIa;Phase I | | | | Yes | False | | |
| NCT04664075 | 24 August 2021 | Predicting Severity and Disease Progression in Influenza-like Illness (Including COVID-19) | Predicting Severity and Disease Progression in Influenza-like Illness | PREDICT-ILI | Imperial College London | 01/12/2020 | 20201201 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04664075 | Not recruiting | No | 18 Years | N/A | All | January 25, 2021 | 100 | Observational | | | United Kingdom | | Christopher Chiu, PhD | | | | Imperial College London |
<br> Inclusion Criteria:
<br>
<br> - Healthy persons aged = 18, and able to give informed consent
<br>
<br> - Patient is admitted to hospital
<br>
<br> - Primary reason for hospital admission is clinical suspicion of a new episode of ARI
<br>
<br> - Onset of the following symptoms within the last 7 days: i. Sudden onset of
<br> self-reported fever OR temperature of = 38°C at presentation AND ii. At least one
<br> respiratory symptom (cough, sore throat, runny or congested nose, dyspnoea) AND iii.
<br> At least one systemic symptom (headache, muscle ache, sweats or chills or tiredness).
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient lacks capacity to provide informed consent
<br>
<br> - Patient has been transferred from another hospital
<br>
<br> - Patient has been previously enrolled in the study
<br> | | Influenza;SARS (Severe Acute Respiratory Syndrome);Respiratory Viral Infection;Respiratory Tract Infections;Infection, Bacterial;Infection Viral;Covid19;RNA Virus Infections | Biological: Respiratory infections | Describe the clinical outcomes of influenza-like illness in hospitalised adults;Describe the aetiology of influenza-like illness in hospitalised adults | | | | Yes | False | | |
| → | NCT04673214 | 24 August 2021 | Evaluation of Prognostic Modification in COVID-19 Patients in Early Intervention Treatment | Prognostic Modification in Patients With COVID-19 Under Early Intervention Treatment at U.M.F 13 and U.M.F 20 | | Gilberto Cruz Arteaga | 16/12/2020 | 20201216 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04673214 | Not recruiting | No | 18 Years | N/A | All | December 16, 2020 | 114 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). | Phase 3 | Mexico | | GILBERTO CR ARTEAGA, specialist | | | | MEXICAN SOCIAL SECURITY INSTITUTE |
<br> Inclusion Criteria:
<br>
<br> - Patients Eligible for Family Medicine Unit No.20 and Family Medicine Unit No.13
<br> belonging to the North DF of the IMSS.
<br>
<br> - Male and female patients
<br>
<br> - Patients over 18 years of age.
<br>
<br> - Patients with compliance with the operational definition COVID-19 and confirmatory
<br> test of P.C.R. positive within the first days of the illness (that are evaluated in
<br> first level of medical attention).
<br>
<br> - Patients with comorbidities such as Type 2 Diabetes Mellitus, Systemic Arterial
<br> Hypertension, Overweight or Obesity.
<br>
<br> - That they agree to sign an informed consent
<br>
<br> - Related to Video Call:
<br>
<br> - That the Family Medicine Unit No.20 and the Family Medicine Unit No.13 belonging to
<br> the North DF of the IMSS have the Installation of Electronic Equipment for Internet
<br> use
<br>
<br> Exclusion Criteria:
<br>
<br> - Severe COVID-19 patients (Ameriten sent immediately to second level of care, hospital)
<br> Patients with any Personal Pathological History of Hematological Diseases. • Patients
<br> allergic to macrolides (Azithromycin) and Ivermectin.
<br> | | Covid19 | Drug: Azithromycin / Ivermectin / Ribaroxaban / Paracetamol;Drug: Azithromycin / Ribaroxaban / Paracetamol | Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS.;Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS→Crosstabulated Outcome in Modification of the Evolution Clinical vs Fails Therapeutic by Type of Treatment in Patients With COVID-19 UMF 13 and UMF 20 of the IMSS;Average Days in COVID-19 Symptoms by Type of Therapy in the UMF 20 and UMF 13 of the IMSS. | 16/08/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04673214 | Yes | False | | Yes |
| NCT04694638 | 24 August 2021 | Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation to Prevent Intubation in COVID-19 Infection | The Use of Combined Prone Positioning and High-Flow Nasal Cannula, and Non-invasive Positive Pressure Ventilation to Prevent Intubation in Acute Hypoxemic and/or Hypercapnic Respiratory Failure Secondary to COVID-19 Infection: A Feasibility, Safety Phase One, Open Label Study | | Mayo Clinic | 14/07/2020 | 20200714 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04694638 | Recruiting | No | 18 Years | 110 Years | All | May 21, 2020 | 24 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | United States | ; | Gustavo Cortes Puentes, MD;Gustavo A Cortes Puentes, MD | | ;CortesPuentes.Gustavo@mayo.edu | ;507-284-3104 | Mayo Clinic |
<br> Inclusion Criteria:
<br>
<br> - Patients with confirmed COVID19 infection or suspected COVID19 infection.
<br>
<br> - Patients requiring HFNC or NIPPV
<br>
<br> - Patients who are clinically stable and able to tolerate the changes in position that
<br> are routinely conducted as part of the standard of care in the medical ICU.
<br>
<br> - Patient should be able to provide informed consent to the study. Any participant
<br> speaking any language will be offered participation.
<br>
<br> - Able to actively participate in Assisted Manual Pronation Therapy per nursing
<br> assessment.
<br>
<br> Exclusion Criteria:
<br>
<br> Contraindication for prone positioning:
<br>
<br> - Intracranial pressure >30 mm Hg or cerebral perfusion pressure <60 mmHg
<br>
<br> - Massive hemoptysis requiring an immediate surgical or interventional radiology
<br> procedure
<br>
<br> - Tracheal surgery or sternotomy during the previous 15 days
<br>
<br> - Serious facial trauma or facial surgery during the previous 15 days
<br>
<br> - Deep venous thrombosis treated for less than 2 days
<br>
<br> - Cardiac pacemaker inserted in the last 2 days
<br>
<br> - Unstable spine, femur, or pelvic fractures
<br>
<br> - Hemodynamic instability or severe cardiac arrhythmia (chronic AFib is not a
<br> contraindication). Mean arterial pressure lower than 60 mm Hg, >1 vasopressor agent or
<br> Norepinephrine equivalent dose >0.06 mcg/kg/min
<br>
<br> - Pregnant women
<br>
<br> - Single anterior chest tube with air leaks
<br>
<br> - Burns on more than 20 % of the body surface
<br>
<br> - Delirium or altered mental status increasing fall risk while in prone position.
<br>
<br> - End-of-life decision before inclusion
<br>
<br> - Subject deprived of freedom, minor, subject under a legal protective measure
<br>
<br> - Unable to actively participate in Assisted Manual Pronation Therapy per nursing
<br> assessment
<br>
<br> - Lacking capacity to provide informed consent.
<br>
<br> - Individuals with mechanical or vascular disease precluding safe displacement of the
<br> head, for example: cervical spinal fusion, limited range of motion, or severe vascular
<br> occlusive disease of the head and neck.
<br>
<br> - Body mass index (BMI) greater than 70 kg/m2, or unable to actively participate in
<br> Assisted Manual Pronation Therapy per nursing assessment at any BMI value.
<br> | | Prone Positioning;Covid19;Hypoxemic Respiratory Failure;ARDS;Non Invasive Ventilation;High Flow Nasal Cannulla | Other: Body position change | Rate of intubation | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05008523 | 24 August 2021 | Opioids and Police Safety Study | Evaluation of an Experimental Educational Module on Opioid-related Occupational Safety to Minimize Barriers toOverdose Response Among Police Officers | OPS | New York University | 21/06/2021 | 20210621 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05008523 | Recruiting | No | 18 Years | N/A | All | January 22, 2021 | 300 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant). | N/A | United States | ; ; | Janie Simmons, EdD;E;Commander | | ;;christopher.ragland@pittsburghpa.gov | ;;412-323-7837 | New York University, School of Global Public Health; |
<br> Inclusion Criteria:
<br>
<br> - Active duty Police Officer
<br>
<br> Exclusion Criteria:
<br>
<br> - Desk only- not active duty
<br> | | Opioid Overdose | Behavioral: Opioids and Police Safety Occupational Risk Reduction Training (OPS);Behavioral: Opioids and Police Safety Occupational Risk Reduction Training (COVID) | Change in Naloxone Behavioral Outcomes in Policing Procedure;Change in Naloxone Behavioral Outcomes in Policing Procedure;Change in Naloxone Behavioral Outcomes in Policing Procedure;Change in Referral Behavioral Outcomes in Policing Procedure;Change in Confiscation Behavioral Outcomes in Policing Procedure;Change in Confiscation Behavioral Outcomes in Policing Procedure | | | | Yes | False | | |
| → | NCT05009134 | 24 August 2021 | Influences of Allergic Rhinitis and Allergen Immunotherapy on SARS-CoV-2 Vaccination | Influences of Allergic Rhinitis and Allergen Immunotherapy on Human Antibody Responses to SARS-CoV-2 Vaccination | | Huazhong University of Science and Technology | 10/08/2021 | 20210810 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05009134 | Recruiting | No | 18 Years | 55 Years | All | June 4, 2021 | 120 | Observational | | | China | ; ; | Zheng Liu, Doctor;Zheng Liu, Doctor;Zheng Liu, Doctor | | ;zhengliuent@hotmail.com;zhengliuent@hotmail.com | ;86 027 83663807;86 027 83663807 | Tongji Hospital; |
<br> Inclusion Criteria:
<br>
<br> 18-55 years; healthy subjects, patients with AR without AIT, or patients with AR with AIT
<br> for more than 1 year
<br>
<br> Exclusion Criteria:
<br>
<br> 1. who infected with COVID-19 previously
<br>
<br> 2. Cannot finish the follow up
<br>
<br> 3. Previous allergic to other vaccines
<br>
<br> 4. who have had severe immunologic, cardiac, liver or metabolic disease, tumors, allergic
<br> diseases, or chronic infection,
<br>
<br> 5. pregnancy or breastfeeding
<br>
<br> 6. Suffered from airway infection or severe infectious diseases in the past 3 months,
<br> prior to this study.
<br> | | Allergic Rhinitis;Allergen Immunotherapy;SARS-CoV-2 | Biological: There is no intervention in this study. | Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay;Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood;Levels of antigen-specific IgE and IgG4, IFN-?, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA→Levels of antigen-specific IgE and IgG4, IFN-?, IL-4, IL-5, IL-10, IL-17A, and IL-21 in serum detected by ELISA;Frequencies and numbers of circulating T cell subsets, B cell subsets, dendritic cells, NK cells in peripheral blood;Virus-specific antibodies levels in serum and humoral immune response as measured by ELISA or HAI assay | | | | Yes | False | | |
| NCT05009186 | 24 August 2021 | Changing of Prostate Specific Antigen Value in Patients With Covid-19 | Changing of PSA With Covid-19 | | Saglik Bilimleri Universitesi | 15/08/2021 | 20210815 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05009186 | Recruiting | No | 45 Years | 70 Years | Male | April 1, 2020 | 100 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | Turkey | ; ; | Omer G Doluoglu, Associate Professor;Omer G Doluoglu, Associate Professor;Omer G Doluoglu | | ;drdoluoglu@yahoo.com.tr;drdoluoglu@yahoo.com.tr | ;+905332157809;+905332157809 | Ankara Training and Research Hospital; |
<br> Inclusion Criteria:
<br>
<br> - Male patients (>45 and <70 years of age) positive PCR test results were included in
<br> the study
<br>
<br> Exclusion Criteria:
<br>
<br> - The patients <45 and >70 years of age who described lower urinary tract symptoms who
<br> had urinary tract infection who a history of prostate biopsy and previous high level
<br> of PSA who history of prostatitis were excluded.
<br> | | Covid19;Prostate Specific Antigen | Other: PSA value | PSA value | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| ISRCTN27613785 | 30 August 2021 | Influence of geographic altitude on the evolution of severe cases of COVID-19 in Ecuador | Influence of geographic altitude on the evolution of COVID-19 patients admitted to the intensive care units (ICUs) in Ecuador | | Hospital de Especialidades Eugenio Espejo | 16/08/2021 | 20210816 | ISRCTN | https://www.isrctn.com/ISRCTN27613785 | Not Recruiting | No | | | Both | 12/02/2021 | 817 | Observational | Multicentre longitudinal case-control observational study (Other) | Not Applicable | Ecuador | Manuel | Jibaja | Av. Gran Colombia & Yaguachi | edison.jibaja@hee.gob.ec | +593 (0)999668588 | | Inclusion criteria: <br> 1. Patients (men and women) 18 years old or older<br> 2. Diagnosed with COVID-19 by RT-PCR<br> 3. Admitted to ICUs in Ecuador located in cities with geographic altitude of 2500 ms above sea level and at sea level<br> 4. Need for mechanical ventilation as part of their management<br> | Exclusion criteria: <br> 1. Patients younger than 18 years of age<br> 2. Patients admitted to ICU for a diagnosis other than COVID-19 and also required mechanical ventilation<br> 3. Foreign patients<br> | Severe cases of COVID-19 (SARS-CoV-2 infection) requiring ICU and mechanical ventilation <br>Infections and Infestations | Retrospective data collection from the cohort of patients diagnosed with severe COVID-19 between the months of March to July 2021, admitted to Intensive Care Units of hospitals located in Ecuadorian cities with a geographical altitude of 2500 m above sea level and at sea level. Information on demographic variables, comorbidities, symptoms, and signs prior to admission to the ICU, severity indexes, and initial management in the ICU will be collected. Laboratory data, hemodynamic variables, and respiratory variables on mechanical ventilation will also be collected, the latter at admission and after 24 h. Data on withdrawal of mechanical ventilation, specific treatments, complications, and prognosis are collected. | Mortality (%) of patients diagnosed with severe COVID-19 between the months of March to July 2021 measured from retrospectively collected hospital data at a single time point | | 01/07/2021 | | No | False | | |
| → | ISRCTN86534580 | 30 August 2021 | PRINCIPLE: A clinical trial evaluating treatments for suspected and confirmed COVID-19 for recovery at home | Platform Randomised trial of Treatments in the Community for Epidemic and Pandemic Illnesses (PRINCIPLE) | | University of Oxford | 22/03/2020 | 20200322 | ISRCTN | https://www.isrctn.com/ISRCTN86534580 | Recruiting | Yes | | | Both | 25/03/2020 | 6000 | Interventional | Pragmatic platform randomized controlled trial of interventions for COVID-19 in primary care (Treatment) | Phase III | United Kingdom | Emma;Julie→Julie;Emma | Ogburn;Allen |
Nuffield Department of Primary Care Health Sciences, University of Oxford
Radcliffe Observatory Quarter, Woodstock Road
;
Nuffield Department of Primary Care Health Sciences, University of Oxford
Radcliffe Observatory Quarter, Woodstock Road
| principle@phc.ox.ac.uk;principle@phc.ox.ac.uk | +44 (0)800 138 0880;+44 (0)800 138 0880 | ; | Inclusion criteria: <br> Current participant inclusion criteria as of 26/04/2021:<br> 1. Participant is willing and able to give informed consent for participation in the study<br> 2. Participant is willing to comply with all trial procedures<br> 3. Suspected COVID-19 using the NHS syndromic definition, or symptoms consistent with COVID-19 (including, but are not limited to, shortness of breath, general feeling of being unwell, muscle pain, diarrhoea and vomiting) and with a positive test for SARS-CoV-2 infection within the past 14 days<br> 4. Aged 65 years or over, aged 18-64 and is experiencing shortness of breath as part of COVID-19 illnesses, or aged 18-64 and has any of the following underlying health conditions:<br> 4.1. Known weakened immune system due to a serious illness or medication (e.g. chemotherapy);<br> 4.2. Known heart disease and/or a diagnosis of high blood pressure<br> 4.3. Known chronic lung disease (e.g. asthma)<br> 4.4. Known diabetes<br> 4.5. Known mild hepatic impairment;<br> 4.6. Known stroke or neurological problem;<br> 4.7. Self-report obesity or body mass index =35 kg/m²<br><br><br> Previous participant inclusion criteria as of 08/06/2020:<br><br> 1. Participant is willing and able to give informed consent for participation in the study<br> 2. Participant is willing to comply with all trial procedures<br> 3. Onset of symptoms of possible COVID-19 in the community (continuous cough and/or high temperature) should be within 14 days of inclusion OR a positive test for SARS-Co-V2 infection which was taken fewer than 15 days ago, AND the participant is unwell with symptoms of COVID-19. These symptoms may include, but are not limited to, shortness of breath, general feeling of being unwell, muscle pain, diarrhoea, vomiting,fever and cough, and they must have had them for fewer than 15 days.<br> 4. Patients aged =50-64 years with any of the following listed comorbidities OR patients aged =65 years with or without comorbidity:<br> 4.1. Known weakened immune system due to serious illness or medication (e.g. chemotherapy)<br> 4.2. Known heart disease and/or hypertension<br> 4.3. Known asthma or lung disease<br> 4.4. Known diabetes not treated with insulin<br> 4.5. Known mild hepatic impairment<br> 4.6. Known stroke or neurological problem<br><br> _____<br><br> Previous inclusion criteria:<br><br> 1. Participant is willing and able to give informed consent for participation in the study<br> 2. Participant is willing to comply with all trial procedures<br> 3. Onset of symptoms of possible COVID-19 in the community (continuous cough and/or high temperature) should be within 7 days of inclusion<br> 4. Patients aged =65 with or without comorbidity, and patients aged =50 years with the following listed comorbidities:<br> 4.1. Known weakened immune system due to serious illness or infection (e.g. chemotherapy)<br> 4.2. Known heart disease<br> 4.3. Known asthma or lung disease<br> 4.4. Known diabetes not treated with insulin<br> 4.5. Known mild hepatic impairment<br> 4.6. Known stroke or neurological problem<br> | Exclusion criteria: <br> Current participant exclusion criteria as of 26/04/2021:<br> 1. Patient currently admitted in hospital<br> 2. Almost recovered (generally much improved and symptoms now mild or almost absent)<br> 3. Judgement of the recruiting clinician deems ineligible<br> 4. Previous randomisation to an arm of the PRINCIPLE trial<br><br> Additional exclusion criteria specific to each intervention arm are listed in the Protocol. For participation, participants must be eligible to be randomised to at least one intervention arm as well as the Usual Care arm.<br><br><br> Previous participant exclusion criteria as of 16/06/2020:<br><br> 1. Patient currently admitted in hospital<br> 2. Almost recovered (generally much improved and symptoms now mild or almost absent)<br> 3. Judgement of the recruiting clinician deems ineligible<br> 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides<br><br> 5. Exclusion criteria related to azithromycin:<br> 5.1. Pregnancy<br> 5.2. Breastfeeding<br> 5.3. Known severe hepatic impairment<br> 5.4. Known severe renal impairment<br> 5.5. Known myasthenia gravis<br> 5.6. Previous adverse reaction to, or currently taking, azithromycin or other macrolides or ketolides<br> 5.7. Patients taking the following drugs: hydroxychloroquine or chloroquine, sotalol, amiodarone, ciclosporin, digoxin, bromocriptine, cabergoline, ergotamine, ergometrine, methysergide or any ergot derivatives<br> 5.8. Already taking antibiotics for an acute condition Known congenital or documented QT prolongation<br> 5.9. Known allergy to soya or peanut due to the risk of hypersensitivity reactions<br><br> _____<br><br> Previous exclusion criteria as of 08/06/2020:<br><br> 1. Patient currently admitted in hospital<br> 2. Almost recovered (generally much improved and symptoms now mild or almost absent)<br> 3. Judgement of the recruiting clinician deems ineligible<br> 4. Patient already taking an intervention arm medication (hydroxychloroquine or azithromycin) or other macrolides or ketolides<br><br> Additional exclusions specific to each intervention arm are listed below. Participants can take part in the study if they are eligible to be randomised to at least one intervention arm as well as the control arm.<br><br> 5. Exclusion criteria related to hydroxychloroquine:<br> 5.1. Pregnancy<br> 5.2. Breastfeeding<br> 5.3. Known severe hepatic impairment<br> 5.4. Known severe renal impairment<br> 5.5. Known porphyria<br> 5.5. Type 1 diabetes or insulin dependent type 2 diabetes mellitus<br> 5.6. Known G6PD deficiency<br> 5.7. Known myasthenia gravis<br> 5.8. Known severe psoriasis<br> 5.9. Known severe neurological disorders (especially those with a history of epilepsy—may lower seizure threshold)<br> 5.10. Previous adverse reaction to, or currently taking, hydroxychloroquine or chloroquine<br> 5.11. Patients currently taking the following drugs: penicillamine, amiodarone, ciclosporin, digoxin, azithromycin or other macrolides or ketolid | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations <br>Coronavirus infection, unspecified site | <br> Current interventions as of 12/05/2021:<br> The study treatment of Favipiravir is 9 x 200mg tablets (1800mg) to be taken twice a day on day 1 (loading dose) and then 4 x tablets (800mg) twice daily for four days (maintenance dose) - a total of 50 tablets, over 5 days. The study treatment of Colchicine is 500mg tablet once daily for<br> 14 days. The study treatment of Ivermectin will be 3mg tablets once daily (300µg/kg body weight) for 3 days.<br><br> _____<br><br> Previous interventions as of 26/04/2021:<br> The PRINCIPLE trial platform is currently evaluating usual care alone vs usual care plus Colchicine vs usual care plus Favipiravir.<br><br> A platform trial, in contrast to say a traditional two-arm design, allows multiple arms to be considered simultaneously, and interventions can be dropped and replaced as evidence emerges for effectiveness or lack of it. The intent is to establish an on-going trial infrastructure within a master protocol that uses all the data already accumulated for the assessment of current and subsequently introduced interventions. New interventions will only be added after submission to the appropriate approval bodies.<br><br> The evaluation of any new interventions will be governed by the master protocol, including adaptive and decision criteria. In addition, the inclusion of any new interventions will require supplementary appendices to the protocol and SAP.<br><br> The study treatment of Favipiravir is 9 200mg tablets (1800mg) to be taken twice a day on day 1 (loading dose) and then 4 tablets (800mg) twice daily for four days (maintenance dose). A total of 50 tablets, over 5 days. The study treatment of Colchicine is 500mg once daily (tablet) | <br> Current primary outcome measure as of 18/01/2021:<br><br> The main objective of the trial is to assess the effectiveness of the interventions in reducing time to recovery and in reducing the incidence of hospitalisation and/or death.The trial has co-primary endpoints:<br> 1. Time taken to self-reported recovery, defined as the first instance that a participant reports feeling recovered from possible COVID-19<br> 2. Hospitalisation and/or death<br><br> Both collected within 28 days of randomisation from patient report, study partner report, medical records, daily online symptom scores .<br> _____<br><br> Previous primary outcome measure as of 10/06/2020:<br><br> Hospital admission or mortality related to suspected COVID-19 infection assessed using reports of patients’ medical records, from enrolment up to 28 days after completing treatment<br><br> _____<br><br> Previous primary outcome measure as of 08/06/2020:<br><br> Hospital admission or mortality related to suspected COVID-19 infection.<br><br> _____<br><br> Previous primary outcome measure:<br><br> Hospital admission or death, for patients aged =50 years with comorbidity, and aged =65 years with or without comorbidity and suspected COVID-19 infection during time of prevalent COVID-19 infections, measured by hospital admission or mortality related to suspected COVID-19 within 28 days<br> | | 24/09/2022 | | Yes | True | parent | |
| ISRCTN55218215 | 30 August 2021 | Trial of financial incentives for preventing postpartum return to smoking | Three-arm randomised controlled trial of Financial Incentives for Preventing Postpartum return to Smoking: the FIPPS trial | | University of Stirling | 05/07/2019 | 20190705 | ISRCTN | https://www.isrctn.com/ISRCTN55218215 | Recruiting | No | | | Female | 01/02/2019 | 900 | Interventional | Randomised controlled trial (Prevention) | Not Applicable | United Kingdom | | | | | | | Inclusion criteria: <br> Current inclusion criteria as of 20/11/2020:<br><br> 1. Confirms having not smoked a single puff of a cigarette for at least four weeks<br> 2. Is between 34 weeks gestation and two weeks postpartum<br> 3. Expired carbon monoxide (CO) reading<br> 4. Aged at least 16 years<br> 5. Intends remaining abstinent from smoking after the birth<br> 6. Able to speak and read English<br> 7. If participant needs to use a single-person, self-administered carbon monoxide (iCO) monitor, she needs to have a device (e.g., phone) that is compatible with the monitor app<br> 8. Willing and able to give written informed consent for participation in the study<br><br> _____<br><br> Previous inclusion criteria as of 15/10/2020:<br><br> 1. At a time between 34 weeks gestation and 2 weeks postpartum, reports having not smoked a single puff of a cigarette since their last quit attempt in pregnancy<br> 2. Reports having not smoked a single puff of a cigarette for at least four weeks<br> 3. If the woman needs to use a Bedfont single-person, self-administered iCO monitor (e.g., during COVID-19 restrictions on face-to-face contact), has a device (e.g. phone) that is compatible with using the iCO monitor app<br> 4. Expired carbon monoxide (CO) reading < 4 parts per million (ppm)<br> 5. Aged at least 16 years<br> 6. Intends remaining abstinent from smoking after the birth<br> 7. Able to speak and read English<br> 8. Willing and able to give informed consent for participation in the study<br><br> _____<br><br> Previous inclusion criteria:<br><br> 1. At 36 weeks gestation reports having not smoked a single puff of a cigarette since beginning a quit attempt during pregnancy<br> 2. Expired carbon monoxide (CO) reading < 4 parts per million (ppm)<br> 3. Aged at least 16 years<br> 4. Intends remaining abstinent from smoking after the birth<br> 5. Able to speak and read English<br> 6. Willing and able to give informed consent for participation in the study<br> | Exclusion criteria: <br> Current exclusion criteria as of 20/11/2020:<br><br> 1. Reports having smoked even a single puff of a cigarette within the last four weeks<br> 2. Is less than 34 weeks gestation or more than two weeks postpartum<br> 3. Expired CO reading >3ppm<br> 4. Does not intend to remain abstinent from smoking after giving birth<br> 5. Insufficient understanding of spoken and written English<br> 6. Needs to use single-person, self-administered iCO monitor and does not have a device (e.g., phone) that is compatible with using the iCO monitor app<br> 7. Unwilling and or unable to give written informed consent for participation in the study<br><br> _____<br><br> Previous exclusion criteria as of 15/10/2020:<br><br> 1. At a time between 34 weeks gestation and 2 weeks postpartum woman reports having smoked even a single puff of a cigarette since her last quit attempt in pregnancy<br> 2. Reports smoking even a single puff of a cigarette in the last four weeks<br> 3. Does not have a device (e.g. phone) that is compatible with using the iCO monitor app<br> 4. Expired CO reading > 3 ppm<br> 5. Does not intend to remain abstinent from smoking after giving birth<br> 6. <16 years old<br> 7. Insufficient understanding of spoken and written English<br><br> _____<br><br> Previous exclusion criteria:<br><br> 1. At 36 weeks gestation reports having smoked even a puff of a cigarette since commencing a pregnancy quit attempt<br> 2. Expired CO reading > 3 ppm<br> 3. Does not intend to remain abstinent from smoking after giving birth<br> 4. <16 years old<br> 5. Insufficient understanding of spoken and written English<br> | Prevention of smoking relapse in women following the birth of a child <br>Not Applicable | <br> The three groups are:<br> 1. No incentives – postpartum care will proceed as usual.<br><br> 2. Incentives will be offered up to three months postpartum. There will be three incentive payments of a £20 voucher. Each voucher payment will be based on self-report of not smoking a single puff of a cigarette since the birth and on expired CO validated confirmation of smoking abstinence (<8 ppm) at 1, 2 and 3 months postpartum.<br> Significant Other Supporter payments: Participating women will also be given the option to identify and recruit a ‘Significant Other Supporter’ (SOS) (a member of their community who agrees to support the woman to remain smoke-free, including attending smoking cessation validation visits). The women’s SOS will be offered an incentive of £60 if the woman achieves CO validated abstinence (<8 ppm) at 3 months postpartum and the SOS is also confirmed as abstinent (CO <8 ppm). The total value of incentives offered to group 2, including those offered to the participant and the SOS is £120.<br><br> 3. Incentives will be offered up to 12 months postpartum. In addition to the incentives received by group 2, those in this group can receive a £60 voucher at 6, 9 and 12 months postpartum. Again, voucher payments will be dependent on CO confirmation of self-reported abstinence. The total value of incentives offered to group 3, including those offered to the participant and SOS is £300.<br><br> (added 15/10/2020)<br> In instances where it is not possible to conduct CO validation, due to COVID-19 restrictions, smoking abstinence will be by self-report alone.<br> | <br> Current primary outcome measure as of 15/10/2020:<br><br> Smoking status at 12 months postpartum. Self-reports of having not smoked a single puff of a cigarette since the woman’s last quit date in pregnancy will be confirmed by an expired CO reading of <8 ppm, and also by saliva cotinine (only among those reporting not currently using e-cigarettes or NRT) at 12 months postpartum.<br><br> _____<br><br> Previous primary outcome measure:<br><br> Smoking status at 12 months postpartum. Self-reports of having not smoked a single puff of a cigarette since the birth of the baby will be confirmed by an expired CO reading of <8 ppm, and also by saliva cotinine (only among those reporting not currently using e-cigarettes or NRT) at 12 months postpartum.<br> | | 30/11/2022 | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| IRCT20200117046160N2 | 30 August 2021 | "Effects of multimodal rehabilitation on recovery of ICU Acquired weakness following COVID-19" | Evaluation effects of multimodal rehabilitation on recovery of ICU Acquired weakness following coronavirus infection(COVID-19) | | Mazandaran University of Medical Sciences | 2021-08-05 | 20210805 | IRCT | http://en.irct.ir/trial/52484 | Recruiting | No | no limit | no limit | Both | 2020-03-20 | 15 | interventional | Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. | N/A | Iran (Islamic Republic of);Iran (Islamic Republic of) | Hanie Adib | | No 6, 3th Ave, Razi St, Mostafavian Clinic , Sports Medicine Clinic | hanieadib@gmail.com | +98 11 3336 6552 | Mazandaran University of Medical Sciences | Inclusion criteria: Definitive diagnosis of Coronavirus based on Polymerase Chain Reaction (PCR) or lung CT Scan and expert opinion<br>Intensive Care Unit Acquired Weakness (ICUAW) diagnosis based on the following criteria: - Total muscle strength points of 6 muscle groups bilaterally(Forearm flexion, wrist extension, Hip flexion, knee extension, Ankle dorsiflexion ,Arm abduction) in manual examination according to Medical Research Council(MRC) criteria is less than 48 (out of 60 total points) - Normal consciousness based on Glasgow Coma Scale(GCS) (score 15 out of 15) - Opinion of an Anesthesiologist or Intensive Care Fellowship - History of hospitalization in ICU for more than 48 hours (with and without the need for Mechanical ventilation) | Exclusion criteria: Loss of consciousness<br>Uncontrolled hypertension means: resting systolic blood pressure> 180 mmHg and / or resting diastolic blood pressure> 110 mmHg<br>Chest pain<br>Uncontrolled sinus tachycardia (> 120 beats / min) or Sinus bradycardia (HR <60)<br>Concurrent heart disease such as: Decompensated heart failure and evidence of Ischemic heart disease, Symptomatic arrhythmia<br>Hypoxia at rest (Oxygen saturation (SPO2)< 88%)<br>Pulmonary artery hypertension (Pulmonary Artery Pressure(PAP) > 30mmHg)<br>Fever or Acute systemic disease<br>Uncontrolled Diabetes Mellitus( DM)<br>Severe Orthopedic or Neurological problems that prevent exercise<br>Other metabolic conditions such as: Acute thyroiditis, Hyperkalemia, Hypokalemia and Hypovolemia (Until adequate treatment)<br>Severe Psychological disorders<br>Poor compliance<br>Problem transporting the patient to the Rehabilitation Center<br>Absence of the patient from rehabilitation sessions (More than 2 sessions) | Condition 1: Novel Coronavirus(COVID-19). Condition 2: Intensive Care Unit Acquired Weakness. <br>Clinically-epidemiologically diagnosed COVID-19 <br>Critical illness myopathy;U07.1;G72.81 | Intervention group: Patients return to the rehabilitation center three weeks after discharge from the hospital, and the rehabilitation program will be designed twice a week for two months (16 sessions in total) and the duration of each session will be approximately 40 minutes for each patient. Exercises for each session include: warm up and cool down, strength exercises for the upper and lower limbs, and Inspiratory muscle training (IMT) with the KH5 digital Power Breath (start with a resistance of 30% of maximal inspiratory pressure) . Aerobic exercise with a stationary bike and treadmill also starts according to the patient's ability and gradually increases its duration and intensity. Gradually increase the intensity of the exercises during the sessions ( in Aerobic , strength and breathing exercises) in proportion to the individual's progress. All sessions will be performed under supervision. Vital signs and oxygen saturation(SPO2) will be checked at the beginning of each session. After the rehabilitation sessions, the initial examinations (includes: peripheral and inspiratory muscle strength, 6-minute walk test, dyspnea scale, anxiety and depression scale, quality of life, body mass analysis)will be repeated.. | Peripheral muscle force. Timepoint: Before the intervention and after the intervention (after 16th session). Method of measurement: Medical Research Council grading system.;Quality of life. Timepoint: Before the intervention and after the intervention (after 16th session). Method of measurement: World Health Organization Questionnaire. | | | | No | False | | |
| → | IRCT20201227049854N1 | 30 August 2021 | Evaluation of the effect of silymarin on hepatotoxicity induced by Remdesivir | Evaluation of the effect of Silymarin on hepatotoxicity induced by Remdesivir in patients with COVID-19 admitted to Shahrekord hospitals | | Shahre-kord University of Medical Sciences | 2021-07-11 | 20210711 | IRCT | http://en.irct.ir/trial/53327 | Not Recruiting | No | 18 years | no limit | Both | 2021-02-19 | 70 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are randomly divided into one of three groups: A (patient 1 to 35), group B (36 to 70), and group C (71 to 105), Blinding description: In this study, residents, patients, and statistical counselors are kept blind. | 3 | Iran (Islamic Republic of) | Zahra Habibi | | Hajar Hospital, Parastar Street | Hajar-Hospital@skums.ac.ir | +98 38 3222 0016 | Shahre-kord University of Medical Sciences | Inclusion criteria: Patients with positive covid19 PCR test who have been treated with Remdesivir<br>Spo2<93%<br>Patient with lung infiltration<br>Absence of underlying liver disease<br>Liver enzymes less than 5 times normal | Exclusion criteria: Increased liver enzymes more than 5 times normal<br>Patient dissatisfaction<br>Pregnant or lactating patients<br>Patients with glomerular filtration less than 50 mg / min | COVID-19. <br>COVID-19, virus identified;U07.1 | Intervention 1: Intervention group: Remdesivir + Livergel 140 mg 3 times a day for 1 week. Intervention 2: Control group: Remdesivir + placebo 3 times a day for 1 week. | Direct Billirubin. Timepoint: Measurement of liver enzymes on the first and seventh days of the study. Method of measurement: Measurement of liver enzymes by BT 3500 device.;Total Billirubin. Timepoint: Measurement of liver enzymes on the first and seventh days of the study. Method of measurement: Measurement of liver enzymes by BT 3500 device.;Aspartate Aminotransferase. Timepoint: Measurement of liver enzymes on the first and seventh days of the study. Method of measurement: Measurement of liver enzymes by BT 3500 device.;Alanine Aminotransferase. Timepoint: Measurement of liver enzymes on the first and seventh days of the study. Method of measurement: Measurement of liver enzymes by BT 3500 device.;Alkaline Phosphatase. Timepoint: Measurement of liver enzymes on the first and seventh days of the study. Method of measurement: Measurement of liver enzymes by BT 3500 device.→Alkaline Phosphatase. Timepoint: Measurement of liver enzymes on the first and seventh days of the study. Method of measurement: Measurement of liver enzymes by BT 3500 device.;Alanine Aminotransferase. Timepoint: Measurement of liver enzymes on the first and seventh days of the study. Method of measurement: Measurement of liver enzymes by BT 3500 device.;Aspartate Aminotransferase. Timepoint: Measurement of liver enzymes on the first and seventh days of the study. Method of measurement: Measurement of liver enzymes by BT 3500 device.;Total Billirubin. Timepoint: Measurement of liver enzymes on the first and seventh days of the study. Method of measurement: Measurement of liver enzymes by BT 3500 device.;Direct Billirubin. Timepoint: Measurement of liver enzymes on the first and seventh days of the study. Method of measurement: Measurement of liver enzymes by BT 3500 device. | | | | No | False | | |
| IRCT20180205038619N2 | 30 August 2021 | Evaluation of the effectiveness of TDCS (Transcranial Direct Current Stimulation) in the treatment of prolonged decreased of sense of smell in patients with Covid-19 | Evaluation of the effectiveness of TDCS (Transcranial Direct Current Stimulation) in the treatment of hyposmia in patients with Covid-19 | | Iran University of Medical Sciences | 2021-08-30 | 20210830 | IRCT | http://en.irct.ir/trial/53545 | Not Recruiting | No | 18 years | 60 years | Both | 2021-09-10 | 10 | interventional | Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. | N/A | Iran (Islamic Republic of) | Katayoun Moradi | | Department of Physical Medicine and Rehabilitation, Firuzgar Hospital, Valiasr Square, Tehran | katayounmoradi69@gmail.com | +98 21 8214 1229 | Iran University of Medical Sciences | Inclusion criteria: Age between 18 and 60 years<br>Loss of sense of smell after Covid-19 (anosmia that has not improved for more than a month after the onset of symptoms and with routine treatment)<br>Decreased of sense of smell after Covid-19 (anosmia that has not improved for more than a month after the onset of symptoms and with routine treatment) | Exclusion criteria: Pregnancy<br>Seizures or family history of seizures<br>Implanted metal devices such as pacemakers, metal plate and wire<br>History of brain surgery | covid-19. <br>Coronavirus infection, unspecified;B34.2 | The intervention group will receive a direct current of 2 mA for 20 minutes. In all patients, the anode electrode is located on the left DLPFC region and the cathode electrode is located on the right DLPFC region. The excitation current will be generated by a direct current generator with a maximum current of 4 mA (NeuroStim2 dual channel device). To transmit current, a 35 cm square electrode covered with 0.9% saline-impregnated sponge will be used.. | Olfactory sensitivity. Timepoint: Patients are assessed before the intervention and one week after 4 sessions of TDCS. Method of measurement: Participants' olfactory sensitivity will be measured by the Smell Identification Test (SIT) . In this method, 24 Iranianized odor such as rose, caffeine, saffron, etc. will be used and a score of 24 will be given, with a score of 19 to 24 being considered the normal range. A score of 14 to 18 is mild microsmia, a score of 10 to 13 is severe microsmia, and a score of 0 to 9 is anosmia. | | | | Yes | False | | |
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| EUCTR2021-002387-50-DE | 30 August 2021 | A trial testing the safety and effects of two vaccines in healthy adults | A Phase II, open-label, rollover trial to evaluate the safety and immunogenicity of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 in
BNT162-01 trial subjects, or two boosting doses of Comirnaty in BNT162-04 trial subjects - A trial investigating the safety and effects of one or two additional doses of Comirnaty™ or one dos | | BioNTech SE | 11/06/2021 | 20210611 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-002387-50 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 22/07/2021 | 549 | Interventional clinical trial of medicinal product | Controlled: no
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
Number of treatment arms in the trial: 2
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany | Clinical Operations | | An der Goldgrube 12 | christian.hucke@external.biontech.de | 0049613190848084 | BioNTech SE | Inclusion criteria: <br>1. Have given informed consent by signing the informed consent form (ICF) before initiation of any trial-specific procedures.<br>2. Willing and able to comply with scheduled visits, treatment schedule, laboratory tests, lifestyle restrictions (including those requested by the German and federal Governments, e.g., to follow good practices to reduce chances of spreading COVID 19), and other requirements of the trial.<br>3. Have received BNT162 vaccine candidates in the BNT162-01 or BNT162-04 trials.<br>4. Remain overall healthy (i.e., has not medically deteriorated significantly since participation in the parent trial, is not anticipated to die in the next 26 weeks, and is able to provide blood as specified by the trial without anticipated, deleterious medical consequences) in the clinical judgment of the investigator based on medical history and physical examination. Screening clinical laboratory tests are to assess the subjects “new baseline” unless required for eligibility (e.g., platelets).<br>5. Agree not to enroll in another trial of an IMP, starting after Visit 0 and continuously until Visit 5 (Day 50).<br>6. Less than 18 months have passed since their last IMP injection in their parent trial.<br>7. If they received 30 µg Comirnaty twice in the BNT162-01 trial, Visit 1 in this trial is =24 weeks after their last IMP injection, unless the subject is a Cohort 13 transplant subject of the BNT162-01 trial.<br>8. If they received any other BNT162 vaccine candidate than Comirnaty in the BNT162-01 or BNT162-04 trial or are a Cohort 13 transplant subject, Visit 1 in this trial is =12 weeks after their last IMP injection.<br>9. Have not been diagnosed with SARS-CoV-2 infection in the 12 weeks prior to Day 1 (baseline). Subjects who screen-fail on this criterion may be rescreened.<br>10. Platelets = 125,000 to 550,000/mm3.<br>11. Chemistry panel: the following apply: alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST) are <3.0 times the upper limit of normal, and/or glomerular filtration rate (GFR) is = 40 mL/min/1.73 m2.<br>12. Immunocompromised subjects may be included if their clinical laboratory values are stable in the context of their disease, and if there is no acute deterioration present with the expected need to change their therapy within the 2 weeks after the anticipated trial vaccination.<br>13. Women of childbearing potential (WOCBP) must test negative in a urine beta-human chorionic gonadotropin (ß-HCG) test at Visits 0 and 1. Women that are post-menopausal or permanently sterilized will be considered as not having reproductive potential.<br>14. WOCBP must agree to practice a highly effective form of contraception during the trial, starting at screening and continuously until Visit 5 (Day 50). <br>15. WOCBP must confirm that they practiced one highly effective form of contraception for the 14 d prior to screening.<br>16. WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted reproduction during the trial, starting after Visit 0 and continuously until Visit 5 (Day 50).<br>17. Men who are sexually active with a WOCBP and have not had a vasectomy must agree to use a highly effective form of contraception with their female partner of childbearing potential during the trial, starting after Visit 0 and continuously until Visit 5 (Day 50).<br>18. Men must be willing to refrain from sperm donation, starting after Visit 0 and continuously until Visit 5 (Day 50).<br><br><br>Are the trial subjects under 18? no<br>Number of subjects fo | Exclusion criteria: <br>1. Have received any SARS-CoV-2 vaccine outside of the BNT162-01 or BNT162-04 trials.<br>2. Have a known allergy, hypersensitivity, or intolerance to the planned IMP including any excipients of the IMP.<br>3. Have a current febrile illness (body temperature =38.0°C) or other acute illness within 48 h prior to Day 1/IMP injection in this trial. Subjects who screen-fail on this criterion may be rescreened.<br>4. Have received a live or live attenuated vaccine within 30 d prior to Day 1/IMP injection, or any other vaccination within 14 d prior to Day 1/IMP injection. Subjects who screen-fail on this criterion may be rescreened.<br>5. Have an ongoing AE assessed as related to any BNT162-01 or BNT162-04 trial vaccine.<br><br> | Protection against COVID-19 <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: BNT162b2s01<br>Pharmaceutical Form: Concentrate for solution for injection<br><br>Trade Name: COMIRNATY<br>Product Name: COMIRNATY (COVID-19 mRNA vaccine (nucleoside-modified)<br>Pharmaceutical Form: Concentrate for dispersion for injection<br><br> | Timepoint(s) of evaluation of this end point: Timepoints are given in the description. See also section 9.4.2 of the study protocol.;Primary end point(s): For all Group A and Group B subjects:<br>• The proportion of subjects in each treatment group with at least one SAE or the proportion of AESIs occurring up to 26 weeks after the first IMP injection.<br>For Group A and a selected subset of Group B subjects:<br>• The frequency of solicited local reactions (pain, tenderness, erythema/redness, induration/swelling) at the injection site recorded up to 7 d after each IMP injection.<br>• The frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue/tiredness, fever, chills, nausea, new or worsened muscle pain, new or worsening joint pain) recorded up to 7 d after each IMP injection.<br>For Group A subjects only:<br>• The proportion of subjects with at least one unsolicited TEAE or at least one AE related to IMP occurring up to 28 d after IMP injection in each treatment group.;Secondary Objective: To describe changes in SARS-CoV-2 neutralizing antibody titers from baseline to reference and SARS-CoV-2 SA variant (B.1.351);Main Objective: To determine the safety and tolerability of one or two boosting doses of Comirnaty or one dose of BNT162b2s01 in BNT162-01 trial subjects, or two boosting doses of Comirnaty in BNT162-04 trial subjects. | | | | Yes | True | parent | |
| → | EUCTR2021-002613-34-NL | 30 August 2021 | Effectivity of COVID-19 vaccination in people with Down syndrome | Prospective monitoring of antibody response following COVID-19 vaccination in patients with Down Syndrome - PRIDE study | | University Medical Center Utrecht | 11/06/2021 | 20210611 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-002613-34 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 30/06/2021 | 640 | Interventional clinical trial of medicinal product | Controlled: no
Randomised: no
Open: no
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Netherlands | PRIDE study | | Heidelberglaan 100 | pride-onderzoek@umcutrecht.nl | 0031650177982 | University Medical Center Utrecht | Inclusion criteria: <br>Subjects are eligible for the study if all of the following apply: <br>• Willing to receive routine COVID-19 vaccination with Pfizer, Moderna or AstraZeneca vaccine.<br>• Age: =16 years or <16 years once vaccine is recommended for routine use in this age group<br>• Either Down syndrome or household contacts without Down syndrome of participant with Down syndrome<br><br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: 260<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 340<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range 40<br> | Exclusion criteria: <br>A potential subject who meets any of the following criteria will be excluded from participation in this study:<br>Down syndrome cohort<br>• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).<br>• Organ transplant recipients<br>• Active malignancy or completion of treatment for malignancy in previous 3 months<br>• Infection with Human Immunodeficiency Virus (HIV)<br>• Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.<br><br>Healthy control cohort<br>• As in Down Syndrome cohort<br>Plus<br>• Active medical care for inherited or acquired immune deficiency<br>• Any severe comorbidity for which regular medical care is needed (e.g. heart failure, COPD, diabetes)<br><br> | Persons with Down syndrome;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Trade Name: Comirnaty<br>COVID-19 mRNA Vaccine (nucleoside modified)<br>Pharmaceutical Form: Concentrate for dispersion for injection<br><br>Trade Name: COVID-19 Vaccine Moderna<br>Pharmaceutical Form: Dispersion for injection<br><br>Trade Name: Vaxzevria <br>Pharmaceutical Form: Suspension for injection<br><br> | Main Objective: To assess the antibody response after mRNA (Pfizer/Biontech, Moderna) and viral vector-based (AstraZeneca) SARS-CoV-2 vaccination in people =16 years and children with Down syndrome;Secondary Objective: To assess in adults and children with DS after SARS-CoV 2 vaccination:<br>- durability of the antibody response<br>- SARS-CoV-2-specific T and B cell response<br>- adverse events<br>-Mucosal antibody response and correlation with the antibody response in serum<br>;Primary end point(s): The primary study parameter is the antibody based immune response to vaccination against COVID-19 28 days after the second vaccination as compared to controls. ;Timepoint(s) of evaluation of this end point: 28 days after second vaccination with a COVID-19 vaccine→Timepoint(s) of evaluation of this end point: 28 days after second vaccination with a COVID-19 vaccine;Primary end point(s): The primary study parameter is the antibody based immune response to vaccination against COVID-19 28 days after the second vaccination as compared to controls. ;Secondary Objective: To assess in adults and children with DS after SARS-CoV 2 vaccination:<br>- durability of the antibody response<br>- SARS-CoV-2-specific T and B cell response<br>- adverse events<br>-Mucosal antibody response and correlation with the antibody response in serum<br>;Main Objective: To assess the antibody response after mRNA (Pfizer/Biontech, Moderna) and viral vector-based (AstraZeneca) SARS-CoV-2 vaccination in people =16 years and children with Down syndrome | | | | Yes | False | | |
| EUCTR2021-004035-88-IT | 30 August 2021 | Phase III clinical trial with monoclonal antibodies versus standard of care for the treatment of early-stage COVID-19 | A randomized, open-label, active controlled, parallel group, multicenter phase 3 study to evaluate the efficacy and tolerability of Bamlanivimab and Etesevimab, Casirivimab and Imdevimab, and Sotrovimab versus Standard of Care in patients with mild to moderate COVID-19 disease (AntiCov) - AntiCov | | FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS UNIVERSITA' CATTOLICA DEL SACRO CUORE | 26/08/2021 | 20210826 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-004035-88 | Not Available | No | | | <br>Female: yes<br>Male: yes<br> | | 400 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: yes
Other specify the comparator: SOC (standard of care) as Paracetamol or FANS for home management of COVID-19
Number of treatment arms in the trial: 4
| Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Italy | U.O.C PNEUMOLOGIA | | VIA LARGO FRANCESCO VITO 1 | luca.richeldi@policlinicogemelli.it | +390630155701 | FONDAZIONE POLICLINICO UNIOVERSITARIO AGOSTINO GEMELLI UNIVERSITA CATTOLICA DEL SACRO CUORE | Inclusion criteria: <br>1.Signed Informed Consent Form<br>2. Men or non-pregnant women =12 years of age at the time of randomization<br>3. Agree to the collection of nasopharyngeal swabs<br>4. Patients currently not hospitalized<br>5. Have one or more mild or moderate COVID-19 symptoms such as fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath<br>6. Must have sample collection for first positive SARS-CoV-2 viral infection<br>7. High risk for severe COVID-19 disease defined as the presence of one or more of the following conditions: age=65 years, BMI=30 kg/m2, chronic kidney disease, chronic lung diseases, including COPD (chronic obstructive pulmonary disease), asthma (moderate-to-severe), interstitial lung disease, cystic fibrosis, and pulmonary hypertension, diabetes, heart conditions (such as heart failure, coronary artery disease, cardiomyopathies or hypertension), immunocompromised state, liver disease, stroke or cerebrovascular disease.<br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 400<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 400<br> | Exclusion criteria: <br>1. Have SpO2 =92% on room air at sea level or PaO2/FiO2 <300<br>2. Respiratory rate =30 per minute<br>3. Heart rate =125 per minute<br>4. Hospitalized for COVID-19 disease<br>5. Respiratory failure secondary to COVID-19 disease<br>6. Have known allergies to any of the components used in the formulation of the interventions<br>7. Have hemodynamic instability<br>8. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking intervention<br>9. Have any comorbidity requiring surgery within 7 days, or that is considered life-threatening within 29 days<br>10. Have any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study<br>11. Have a history of a positive SARS-CoV-2 serology test<br>12. Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30 days before dosing (Anti-COVID-19 vaccines are allowed)<br>13. Have received treatment with a SARS-CoV-2 specific monoclonal antibody<br>14. Have a history of convalescent COVID-19 plasma treatment<br>15. Have participated, within the last 30 days, in a clinical study involving an investigational intervention. If the previous investigational intervention has a long half-life, 5 half-lives or 30 days, whichever is longer, should have passed<br>16. Are concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study<br>17. Are pregnant or breast feeding.<br> | Patients with mild to moderate SARS-COV-2 infection. <br>MedDRA version: 20.0
Level: SOC
Classification code 10021881
Term: Infections and infestations
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: SOTROVIMAB<br>Product Name: SOTROVIMAB<br>Product Code: [SOTROVIMAB]<br>Pharmaceutical Form: Solution for infusion<br>Current Sponsor code: SOTROVIMAB<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 62-<br><br>Product Name: BAMLANIVIMAB<br>Product Code: [BAMLANIVIMAB]<br>Pharmaceutical Form: Solution for infusion<br>Current Sponsor code: Bamlanivimab<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 35-<br><br>Product Name: imdevimab<br>Product Code: [imdevimab]<br>Pharmaceutical Form: Solution for infusion<br>Current Sponsor code: imdevimab<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 120-<br><br>Product Name: Etesevimab<br>Product Code: [Etesevimab]<br>Pharmaceutical Form: Concentrate for solution for infusion<br>Current Sponsor code: Etesevimab<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 35-<br><br>Product Name: casirivimab<br>Product Code: [casirivimab]<br>Pharmaceutical Form: Solution for infusion<br>Current Sponsor code: Casirivimab<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 120-<br><br> | Main Objective: The primary objective of the study is:<br>- To assess the efficacy of monoclonal antibodies (Bamlanivimab/Etesevimab, Casirivimab/Imdevimab, Sotrovimab) in patients with COVID-19 by looking at disease progression in terms of hospitalization in intensive care unit, oxygen desaturation =4% and peripheral oxygen saturation =92% during the follow-up period (30 days).;Secondary Objective: The secondary objectives of the study are:<br>- To assess the impact of experimental drugs on safety and tolerability during the 30-day follow-up period,<br>- To assess the impact of experimental drugs on survival during the 30-day follow-up period.;Primary end point(s): The primary endpoint of the study is:<br>- Disease progression defined as: hospitalization in intensive care unit, oxygen desaturation =4% and peripheral oxygen saturation =92% during the follow-up period (30 days).;Timepoint(s) of evaluation of this end point: Timepoint are reported within the endpoint list | | | | Yes | False | | |
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| NCT04479540 | 7 September 2021 | Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With COVID-19 Lung Disease | Assessment of the Risk of Pulmonary Embolism and Coagulation Profile in Patients With SARS Coronavirus (COV-2) Lung Disease | COVIDEP | Hopital Foch | 06/07/2020 | 20200706 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04479540 | Recruiting | No | 18 Years | N/A | All | May 26, 2020 | 220 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | France | ; ; | Colas TCHERAKIAN, MD;Elisabeth HULIER AMMAR, PhD;Colas Tcherakian, MD | | ;drci-promotion@hopital-foch.com; | ;+33146251175; | Foch HOSPITAL; |
<br> Inclusion Criteria:
<br>
<br> - = 18 years
<br>
<br> - Any patient who consults in the emergency room, COVID+ with hospitalization criteria
<br> (dyspnea or desaturation = 95% or chest pain or hemoptysis), including those who have
<br> already performed a CT angiogram upon arrival at the hospital.
<br>
<br> - Positive polymerase chain reaction (PCR) of coronavirus disease or compatible clinical
<br> signs associated with suggestive radiological criteria
<br>
<br> - Fever
<br>
<br> - Cough
<br>
<br> - Myalgia
<br>
<br> - Asthenia
<br>
<br> - Loss of taste/ Anosmia
<br>
<br> - signed informed consent before any study procedure
<br>
<br> - patients affiliated to an appropriate health insurance system
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnancy in progress
<br>
<br> - Patient not having a microbiological diagnosis of SARS Coronavirus (COV-2) infection
<br> or whose symptoms are not suggestive
<br>
<br> - < 18 years
<br>
<br> - Be deprived of liberty or under guardianship
<br>
<br> - Patient with contra-indication to thoracic angiography scanner:
<br>
<br> - State of shock
<br>
<br> - Creatinine clearance < 30 mL/mn in Chronic Kidney Disease (CKD)
<br>
<br> - history of anaphylactic shock or angioedema with iodinated contrast media
<br>
<br> - uncontrolled cardiac decompensation
<br>
<br> - Patient with contra-indication to contrast media (Iomeron350®, Visipaque®):
<br>
<br> - History of immediate major or delayed skin reaction to the injection of a
<br> contrast medium
<br>
<br> - Hypersensitivity to the active substance or to any of the excipients
<br>
<br> - overt thyrotoxicosis
<br>
<br> Patients with renal insufficiency and / or patients with allergy to iodinated contrast
<br> products may be included if they can perform a scintigraphy (the pulmonary scintigraphy
<br> being the alternative diagnostic to the CT angiography for renal insufficiency and / or
<br> allergy to iodinated contrast products).
<br> | | Pneumonia, Viral | Radiation: Angiography scanner | Rate of patients with pulmonary embolism | | | | Yes | False | | |
| → | NCT04480112 | 7 September 2021 | Impact of Covid-19 on Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults | Impact of Frequent Social Interaction Through Communication Technologies in the Cognitive Status of Socially-isolated Older Adults With and Without Cognitive Impairment | | Boston University | 19/07/2020 | 20200719 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04480112 | Not recruiting | No | N/A | N/A | All | June 2, 2020 | 196 | Interventional | Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor). | N/A | United States | | Andrew E Busdon, MD | | | | Professor of Neurology at BU School of Medicine |
<br> Inclusion Criteria:
<br>
<br> - Recent diagnosis from the Boston University Alzheimer's Disease Center of mild AD
<br> (with a recent Mini Mental State Examination score greater than 20)
<br>
<br> - Meet criteria for social isolation- a state in which an individual has a minimal
<br> number of social contacts and lacks engagement with others either physically or
<br> remotely through communication technology.
<br>
<br> - English as their primary language
<br>
<br> - Have access to either a computer, smart device, or telephone
<br>
<br> Exclusion Criteria:
<br>
<br> - Clinically significant depression
<br>
<br> - Alcohol or drug use
<br>
<br> - Cerebrovascular disease, traumatic brain damage, other degenerative disease (e.g.,
<br> Parkinson's disease)
<br>
<br> - Do not have corrected vision of 20/30 or better
<br>
<br> - perform below 80% correct on the speech discrimination test from the Boston Diagnostic
<br> Aphasia Examination
<br>
<br> - Score below 27 on the Mini-Mental State Examination (MMSE)
<br>
<br> - Score below two standard deviations on any element of the Consortium to Establish a
<br> Registry for Alzheimer's Disease (CERAD) Word List Memory test
<br> | | Memory Disorders;Alzheimer Disease;Mild Cognitive Impairment | Behavioral: Technology based social interactions;Other: No research related technology based social interactions | Change in phonemic fluency;Change in cognition;Change in memory performance→Change in memory performance;Change in cognition;Change in phonemic fluency | | | | Yes | False | | |
| NCT04490850 | 7 September 2021 | COVID-19 Seroprevalence Study in French Guiana | COVID-19 Seroprevalence Study in French Guiana | EPI-COVID-POP | Institut Pasteur | 28/07/2020 | 20200728 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04490850 | Recruiting | No | N/A | N/A | All | July 15, 2020 | 1500 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | French Guiana | ; | Claude Flamand, PhD;Claude Flamand, PhD | | ;cflamand@pasteur-cayenne.fr | ;+33 5 94 29 26 15 | Institut Pasteur de la Guyane, Head of Epidemiology Unit; |
<br> Inclusion Criteria:
<br>
<br> - Person going to a prevention and care center or medical biology analysis laboratory as
<br> part of the care, regardless age, regardless of an acute or previous infection with
<br> COVID-19;
<br>
<br> - State of health compatible with a blood sample as defined in the protocol
<br>
<br> Exclusion Criteria:
<br>
<br> - Inability to consent
<br>
<br> - Person under guardianship or curatorship
<br>
<br> - Known pathology or a health problem contraindicated with the collect of blood sample.
<br> | | Coronavirus Infection;Severe Acute Respiratory Syndrome;SARS-CoV Infection;Covid19 | Procedure: Blood sample | Measure of the COVID-19 immunity of the population | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04979871 | 7 September 2021 | SARS-CoV-2 Antibodies and Virus Neutralisation in a Cohort Vaccinted Against COVID-19 | Kinetics and Stability of Anti-SARS-CoV-2 Antibodies and Virus Neutralization After COVID-19 Vaccination in a Swiss Cohort | DER-CoV2-001 | University of Zurich | 25/07/2021 | 20210725 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04979871 | Not recruiting | No | N/A | N/A | All | July 22, 2021 | 50 | Observational [Patient Registry] | | | Switzerland | | Pål Johansen, Prof | | | | University of Zurich, Dept. Dermatology |
<br> Inclusion Criteria:
<br>
<br> - Employed at the USZ Department of Dermatology
<br>
<br> - Vaccinated against Covid-19 at USZ
<br>
<br> - Male and female persons of any age
<br>
<br> - Serum samples collected in 2020 or until June 11th 2021
<br>
<br> - The subject was informed and gave his/her consent to the research project (non-coded
<br> samples and data) and to publish data obtained from analysis of own biological samples
<br>
<br> Exclusion Criteria:
<br>
<br> - Known clinical relevant disease, e.g. immune suppressed by drugs or disease
<br>
<br> - Documented objection of subsequent use and publication of biological samples and
<br> personal health data
<br> | | Vaccine Reaction | Procedure: Venous bleeding | Immunity to Covid-19 vaccines | | | | Yes | False | | |
| → | NCT04982757 | 7 September 2021 | Accelerated TMS for Depression and OCD | COVID-19 Compatible Accelerated TMS Therapy | | Weill Medical College of Cornell University | 17/07/2021 | 20210717 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04982757 | Recruiting | No | 18 Years | 70 Years | All | August 18, 2021 | 300 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United States | ; ; | Conor Liston, MD, PhD;Danielle I Wolk;Danielle Wolk | | ;diw4003@med.cornell.edu;diw4003@med.cornell.edu | ;646-289-5204;646-289-5204 | Weill Medical College of Cornell University; |
<br> Inclusion Criteria:
<br>
<br> - Diagnosis of major depressive disorder OR obsessive-compulsive disorder (DSM-V
<br> criteria)
<br>
<br> - Hamilton Depression Rating Scale score greater than or equal to 18 OR Yale-Brown
<br> Obsessive-Compulsive Scale score greater than or equal to 16
<br>
<br> - Failure to respond in the current episode to at least one antidepressant or other
<br> pharmacotherapy at an adequate dose and duration as measured by a modified
<br> antidepressant treatment history
<br>
<br> - Off antidepressants OR on a stable dose of antidepressants for greater than or equal
<br> to four weeks with plans to remain on this stable dose during the study
<br>
<br> - Capacity to consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Imminent risk of suicide (based on the CSSRS)
<br>
<br> - Current depressive episode duration greater than or equal to 2 years
<br>
<br> - Presence of primary psychiatric diagnoses other than OCD, MDD and/or co-morbid GAD
<br> (ex. PTSD, MDD with psychotic features, primary psychotic illness, Bipolar I or II)
<br>
<br> - Evidence of cognitive impairment (MMSE score falling 1 SD below mean score for his/her
<br> age and education)
<br>
<br> - Evidence of psychotic symptoms on diagnostic interview (interfering with capacity to
<br> consent)
<br>
<br> - Have met criteria for any significant substance use disorder within the past 6 months
<br>
<br> - Recent onset (within 8 weeks of screening) of psychotherapy
<br>
<br> - Prior exposure to any form of TMS during the current depressive episode
<br>
<br> - Participated in any clinical trial with an investigational drug or device within the
<br> past 6 weeks prior to screening
<br>
<br> - Evidence or history of significant neurological disorder including moderate-severe
<br> head trauma, stroke, Parkinson's disease or other movement disorder (except benign
<br> essential tremor), epilepsy
<br>
<br> - History of seizures (except juvenile febrile seizures) or any condition/concurrent
<br> medication that could notably lower seizure threshold
<br>
<br> - Presence of foreign metal bodies/implanted intracranial devices (MRI contraindication)
<br>
<br> - Current pregnancy or planning to conceive during the study
<br>
<br> - Abnormal bloodwork for electrolytes, thyroid or liver function
<br> | | Depression;OCD | Device: MagVenture MagPro System with Brainsight neuronavigation device | Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores for participants with treatment resistant depression;Percent Change in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores for participants with OCD→Percent Change in Yale-Brown Obsessive Compulsive Scale (YBOCS) scores for participants with OCD;Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores for participants with treatment resistant depression | | | | Yes | False | | |
| NCT05000333 | 7 September 2021 | Consequences of Covid-19 on the Psychological and Physical Health of the Nursing Staff and on Their Professional Activity. | The Consequences of Covid-19 on the Psychological and Physical Health of the Nursing Staff of the Hospital of Villeneuve Saint Georges and on Their Professional Activity. (SST-Covid Impact) | | Centre Hospitalier Intercommunal Creteil | 10/08/2021 | 20210810 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05000333 | Not recruiting | No | 18 Years | N/A | All | September 15, 2021 | 282 | Observational [Patient Registry] | | | | | JUNG Camille, MD | | camille.jung@chicreteil.fr | 0157022268 | |
<br> Inclusion Criteria:
<br>
<br> 1. Major patient
<br>
<br> 2. Part of the medical and paramedical staff working at the CHIV,
<br>
<br> 3. Having been reached by Covid-19 during the first wave, between February 1st and June
<br> 30th 2020.
<br>
<br> 4. Patient affiliated to a social security system
<br>
<br> Exclusion Criteria:
<br>
<br> - None
<br> | | Work-related Illness | Other: Self-questionnaire | Physical and psychological health | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| ISRCTN13450549 | 7 September 2021 | Investigating the inflammatory process of COVID-19 | Levels of free IL-18, IL-18 binding protein and granzyme B according to disease severity of COVID-19 | | Surrey and Sussex Healthcare NHS Trust | 12/01/2021 | 20210112 | ISRCTN | https://www.isrctn.com/ISRCTN13450549 | Not Recruiting | No | | | Both | 08/11/2020 | 200 | Observational | Observational trial comprising cross-sectional case-control and longitudinal cohort arms (Screening) | Not Applicable | United Kingdom;England | Syed Muhammad Tahir | Nasser |
East Surrey Hospital
Canada Avenue
| syed.nasser1@nhs.net | +44 (0)7875603852 | | Inclusion criteria: <br> Criteria for Case/Control portion of study:<br> 1. Above 18 years of age<br> 2. Tested for COVID-19, positive or negative<br><br> Criteria for Cohort portions of study:<br> 1. Above 18 years of age<br> 2. COVID-19 positive swab test<br> | Exclusion criteria: <br> Case-Control and Cohort:<br> 1. Does not meet inclusion criteria<br><br> Cohort study only:<br> 1. Not admitted to hospital after presentation to A&E (discharged without admission)<br> | Investigation of inflammatory process in patients with COVID-19 <br>Infections and Infestations | <br> Current interventions as of 24/08/2021:<br><br> The approach is of a case-control and a cohort study, to accumulate data on Total IL-18, IL-18BP, IL-18/BP-Complex levels and Granzyme B levels (as a marker for NK cell and CD8 T-lymphocyte cytotoxicity) in a variety of different patients with and without COVID-19.<br><br> Case-Control: By comparing COVID19 positive patients to healthy controls, we get information about how COVID-19 infection affects IL-18 related parameters generally as compared to those without COVID-19.<br><br> Cohort Analyses: By comparing IL-18 related parameters between COVID-19 positive patients and correlating it to primary (Pa02/Fi02 ratio) and secondary (mortality, oxygenation parameters /clinical features/disease course/biochemical parameters, neutrophil to lymphocyte ratio (NLR) outcomes) we can see how Free-IL-18 levels correlate with disease severity at different time points throughout the disease course. High free IL-18 levels are seen in a condition known as<br> macrophage activation syndrome (MAS), a condition with similarities to severe COVID-19, partly due to failure of release of IL-18BP. IL-18BP release is dependent on a pathway related to IFNgamma release from Natural Killer cells (innate immune system cells). So as to investigate why IL18BP may have impaired release in COVID-19, resulting in a high Free IL-18, the role of IFNgamma and Granzyme B (as a marker of NK cell function) will also be investigated.<br><br> The questions the study is asking, are as follows:<br> Q1: Is there an association between Free IL-18 and COVID-19 disease at time of presentation to hospital? (Case-Control)<br> Q2A: What is the relationship between free IL-18 levels an | <br> Current primary outcome measure as of 24/08/2021:<br><br> Case-Control:<br> High free IL-18 measured at baseline (admission), obtainable through blood sampling analysis<br><br> Cohort Study 1:<br> Lowest Pa02/Fi02 ratio (PFR) obtainable through blood sampling analysis<br><br> Cohort Study 2:<br> PFR measured from baseline to the lowest level during the inpatient stay using patient records<br><br> Cohort Study 3:<br> Granzyme B and IFN-gamma levels measured by blood sampling throughout inpatient stay<br><br><br> _____<br><br> Previous primary outcome measure:<br><br> Case-Control:<br> High free IL-18 measured at baseline (admission), obtainable through blood sampling analysis<br><br> Cohort Study 1<br> Lowest lymphopaenia level during attendance at hospital, obtainable through blood sampling analysis<br><br> Cohort Study 2:<br> Lymphopaenia percentage measured from baseline to the lowest level during the inpatient stay using patient records<br><br> Cohort Study 3:<br> Granzyme B levels measured by blood sampling when attending tertiary care centre for routine appointments<br> | | 14/01/2021 | | No | False | | |
| → | ISRCTN14447421 | 7 September 2021 | COVID-19 in care homes (VIVALDI) | Understanding SARS-CoV-2 infection, immunity and its duration in care home staff and residents in the UK (VIVALDI) | | University College London | 05/06/2020 | 20200605 | ISRCTN | https://www.isrctn.com/ISRCTN14447421 | Recruiting | No | | | Both | 03/06/2020 | 11000 | Observational | Non-randomized observational cohort study (Screening) | Not Applicable | United Kingdom;England→England;United Kingdom | Maria | Krutikov |
Institute of Health Informatics
University College London
222 Euston Rd
| m.krutikov@ucl.ac.uk | - | | Inclusion criteria: <br> 1. Staff and residents aged >65 years from participating Four Seasons Health Care (FSHC) Homes in England<br> 2. Can speak and understand English<br> | Exclusion criteria: None | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> Current interventions as of 10/02/2021:<br> This study will enrol >5000 care home residents and >6500 care home staff from approximately 350 care homes in England between June 2020 and April 2022. Eligible care homes will be identified using registers held by care home providers and through the clinical research network (CRN) and their ENRICH network and will be contacted by study investigators to confirm willingness to participate. Information sheets and consent forms will be distributed by care home managers amongst all staff and residents and will be sent to all documented next of kin of residents. Senior care home members or CRN nurses will be responsible for obtaining informed consent using capacity assessment procedures already in place in the care homes. In cases where participants are unable to provide informed consent, the next of kin will be asked to be a personal consultee and provide written consent on their behalf. If a personal consultee is not available then a member of care home staff will be able to act as a nominated consultee and provide written consent on behalf of the resident as outlined in the consent section of this document.<br><br> 1. Baseline assessment and antibody testing<br> Baseline nasal/throat swabs (Swab 1) will be taken for PCR testing to test for current infection as part of the national roll-out of testing. This will be accompanied by a symptom questionnaire for those sampled. A baseline blood sample (Blood 1) will be taken from all study participants that will be sent for serology testing to look for evidence of past infection. Data will be extracted from the care home electronic systems to capture demographic data on staff and residents including date of entry and exit to the care h | 1. Proportion of care home staff and residents who have been infected with SARS-CoV-2 measured using antibody testing at baseline | | 31/10/2022 | | No | False | | |
| → | CTRI/2021/05/033717 | 7 September 2021 | Vascular surgery outcomes during COVID Pandemic | The Vascular Surgery COVID-19 Collaborative (VASCC) - VASCC | | Christian medical college Vellore | 21-05-2021 | 20210521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45734 | Not Recruiting | No | | | | 31-05-2021 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3/ Phase 4 | United Kingdom;United States of America;United Arab Emirates;Switzerland;Sweden;Sri Lanka;Spain;Russian Federation;New Zealand;Netherlands;Malaysia;Italy;Ireland;India;Hong Kong;Greece;Ghana;Germany;France;Finland;Egypt;Denmark;Brazil;Bahrain;Austria;Australia→ | Albert Abhinay Kota→ | | Department of Vascular Surgery
Christian medical college
Vellore → | albertkota@cmcvellore.ac.in→ | 9789360870→ | Christian medical college Vellore→ | Inclusion criteria: All patients scheduled to undergo vascular surgery during this pandemic→ | Exclusion criteria: Vulnerable population including age <18 years, >80years, pregnant women→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: I739- Peripheral vascular disease, unspecified
Health Condition 3: I838- Varicose veins of lower extremities with other complications
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | Complications in vascular disease, arterial and venous thrombosisTimepoint: 5 years→ | | | | Yes | False | | |
| → | CTRI/2021/05/033721 | 7 September 2021 | Self-Collected Nasal swab, Throat swab, and Finger Prick Blood for detection of COVID-19 infection | Self-Sample Collection and Transportation for detection of SARS-CoV-2 presence using RT-PCR and Antibody Testing Mechanism | | ACES ECOSPHERE LLP | 21-05-2021 | 20210521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56040 | Not Recruiting | No | | | | 26-05-2021 | 240 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Sitanshu Shastri→ | | 16, Narmada Layout, Yogendra Nagar, Nagpur → | drswatimbhise@gmail.com→ | | Government Medical College and Hospital→ | Inclusion criteria: Participant older than 18 with symptoms or recently been in contact with COVID-19 positive patient (High-Risk Individual) and present for COVID-19 testing in OPD, and able to understand and follow instructions for self-collection. OR Participant recently infected with COVID-19 and quarantined in the institutional quarantine center with individual room and home-like atmosphere. <br/ ><br>Participant able to understand the instructions i.e. read, write and speak in any one language i.e. English, Hindi, and Marathi <br/ ><br>Participant for unsupervised self-sample collection should have own fridge for freezing ice gel packs→ | Exclusion criteria: Unable or unwilling to provide informed consent and /or reliable contact information. <br/ ><br>Participant unable to read and write in English, Hindi, or Marathi <br/ ><br>Younger than 16 and older than 65 are not eligible for this study. <br/ ><br>No fridge or active internet connection for at-home sample collection. <br/ ><br>→ | | | To investigate the reliability and evaluate the performance of self-sample collection and transportation, healthcare workers will also extract the sample of subjects and the results will be compared to understand the quality of at-home unsupervised self-collected sample. The methods will be further compared with end result outcomes i.e. +ve or -ve. The match on the end result will provide an inference that the self-sample collection and transportation is feasible testing mechanism.Timepoint: 2 to 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/05/033723 | 7 September 2021 | A study to assess the level of satisfaction in environmental factors
among clinical and non-clinical hospital staff admitted in COVID center | A study to assess the level of satisfaction in environmental factors
among clinical and non clinical hospial staff admitted in COVID center. | | Sharon Manakkandathil Shaji | 21-05-2021 | 20210521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54557 | Not Recruiting | No | | | | 28-05-2021 | 200 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | SHARON MANAKKANDATHIL SHAJI→ | | Prasanna School of Public Health,
Department of Hospital Administration
MAHE, MANIPAL, KARNATAKA, 576104
INDIA → | brayal.dsouza@manipal.edu→ | 9900405393→ | MAHE→ | Inclusion criteria: 1. All clinical and non-clinical hospital staffs admitted at COVID center <br/ ><br>2. those staff willing to participate in the study→ | Exclusion criteria: 1. Patients not willing to participate <br/ ><br>2. Patients who opted for home quarantine during the stay in COVID center.→ | Health Condition 1: A00-B99- Certain infectious and parasitic diseases
→ | | To identify the lower satisfaction levels within the COVID center and to <br/ ><br>obtain a post discharge follow up to ensure the suggestions are taken into consideration and to <br/ ><br>provide counseling as per the need arise.Timepoint: 3 MONTHS→ | | | | Yes | False | | |
| → | CTRI/2021/05/033736 | 7 September 2021 | A Clinical Study to Test the Use of Capsule Molnupiravir in Adult Patients with COVID 19 with Lung Involvement | A Phase III, Multicentric, Prospective, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Molnupiravir in Adult Indian Patients with Moderate COVID 19 | | Hetero Labs Limited | 21-05-2021 | 20210521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56019 | Not Recruiting | No | | | | 25-05-2021 | 1282 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Shubhadeep Sinha→ | | 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India. → | sreenivasa.chary@heterodrugs.com→ | 04023704923→ | Hetero Labs Limited→ | Inclusion criteria: 1. Patients aged â?¥18 and â?¤60 years and voluntarily willing to provide signed and dated informed consent. <br/ ><br>2. Patients with laboratory confirmed COVID-19 by SARS CoV2 positive RT-PCR test (within 48 hours prior to enrollment) <br/ ><br>3. Patients with moderate COVID-19 disease i.e., pneumonia with no signs of severe disease <br/ ><br>4. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his/her partner during the study period and for at least 28 days following the last study treatment.→ | Exclusion criteria: 1. Patients contraindicated or with history/evidence of hypersensitivity to Molnupiravir administration or any of the components of formulation. <br/ ><br>2. Patients with severe disease <br/ ><br>3. Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN <br/ ><br>4. Patients currently taking nucleos(t)ide analogues/ immunosuppressive treatments within 30 days <br/ ><br>5. Patients with a history of acute pancreatitis within 3 months <br/ ><br>6. Severe renal impairment [creatinine clearance (CrCl) <30 mL/min] <br/ ><br>7. Having used Molnupiravir or participated in any other interventional clinical study within 30 days→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Molnupiravir: Molnupiravir 800 mg (4 capsules of 200 mg) administered orally every 12 hours for 5 days (10 doses total) plus Standard of Care<br>Control Intervention1: Standard of Care: Standard of care as per the Clinical Guidance for Management of Adult COVID-19 by ICMR<br>→ | Proportion of patients with clinical improvementTimepoint: Day 14→ | | | | Yes | False | | |
| → | CTRI/2021/05/033739 | 7 September 2021 | A Clinical Study to Test the Use of Capsule Molnupiravir in COVID-19 Patients with Mild Symptoms and without Lung Involvement | A Phase III, Multicentric, Prospective, Randomized, Parallel Study to Evaluate the Efficacy and Safety of Molnupiravir in Adult Indian Patients with Mild COVID-19 | | Hetero Labs Limited | 21-05-2021 | 20210521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55993 | Not Recruiting | No | | | | 24-05-2021 | 1218 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 3 | India→ | Dr Shubhadeep Sinha→ | | 7-2-A2, Hetero Corporate, Industrial Estates, Sanath Nagar, Hyderabad, Telangana, India. → | sreenivasa.chary@heterodrugs.com→ | 04023704923→ | Hetero Labs Limited→ | Inclusion criteria: 1. Patients aged â?¥18 and â?¤60 years and voluntarily willing to provide signed and dated informed consent. <br/ ><br>2. Patients with laboratory confirmed COVID-19 by SARS CoV2 positive RT-PCR test (within 48 hours prior to enrollment) <br/ ><br>3. Patients with mild COVID-19 disease without any evidence of breathlessness. <br/ ><br>4. 4. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his/her partner during the study period and for at least 28 days following the last study treatment.→ | Exclusion criteria: 1. Patients contraindicated or with history/evidence of hypersensitivity to Molnupiravir administration or any of the components of formulation. <br/ ><br>2. Patients with moderate disease or severe disease <br/ ><br>3. Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN <br/ ><br>4. Patients currently taking nucleos(t)ide analogues/ immunosuppressive treatments within 30 days <br/ ><br>5. Patients with a history of acute pancreatitis within 3 months <br/ ><br>6. Severe renal impairment [creatinine clearance (CrCl) <30 mL/min]→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Molnupiravir and Standard of Care: Molnupiravir 800 mg (4 capsules of 200 mg) administered orally every 12 hours for 5 days<br>AND<br>Standard of Care<br>Control Intervention1: Standard of Care: Standard of Care as per the ICMR Clinical Management Protocol<br>→ | Rate of hospitalizationTimepoint: Up to Day 14→ | | | | Yes | False | | |
| → | CTRI/2021/05/033740 | 7 September 2021 | A study in non-hospitalized COVID-19 patients to assess safety and effectiveness of study drug. | Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID) - Adapt Out COVID | | National Institute of Allergy and Infectious Diseases | 21-05-2021 | 20210521 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=52905 | Not Recruiting | No | | | | 22-05-2021 | 842 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3 | Argentina;Australia;Botswana;Brazil;Canada;Chile;Colombia;Costa Rica;Denmark;Dominica;Ecuador;Guatemala;Haiti;India;Kenya;Malawi;Mexico;Peru;Philippines;Portugal;South Africa;Zimbabwe;Zambia;United States of America;Ukraine;Uganda→ | Rashmi Chitgupi→ | | PPD Pharmaceuticals Development India Private Limited 101, A Wing, Fulcrum, Hiranandani Business Park Sahar Road, Andheri East
→ | rashmi.chitgupi@ppdi.com→ | 91-02266022900→ | PPD Pharmaceuticals Development India Private Limited→ | Inclusion criteria: Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures. <br/ ><br>Individuals â?¥18 years of age. <br/ ><br>Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test(antigen or nucleic acid) from any respiratory tract specimen (e.g., oropharyngeal, NP, or nasal swab, or saliva) collected â?¤168 hours prior to study entry and conducted at any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent or any non-US DAIDS-approved laboratory. <br/ ><br> <br/ ><br>Participants must be expected to begin study treatment no more than 10 days from self-reported onset of COVID-19 related symptoms or measured fever, defined as the self-reported date of first reported sign/symptom from the following list: <br/ ><br>subjective fever or feeling feverish <br/ ><br>cough <br/ ><br>shortness of breath or difficulty breathing at rest or with activity <br/ ><br>sore throat <br/ ><br>body pain or muscle pain/aches <br/ ><br>fatigue <br/ ><br>headache <br/ ><br>chills <br/ ><br>nasal obstruction or congestion <br/ ><br>nasal discharge <br/ ><br>loss of taste or smell <br/ ><br>nausea or vomiting <br/ ><br>diarrhea <br/ ><br>documented temperature >37.8°C <br/ ><br>One or more of the following signs/symptoms present within 48 hours prior to study entry: <br/ ><br>subjecive fever or feeling feverish <br/ ><br>cough <br/ ><br>shortness of breath or difficulty breathing at rest or with activity <br/ ><br>sore throat <br/ ><br>body pain or muscle pain/aches <br/ ><br>fatigue <br/ ><br>headache <br/ ><br>chills <br/ ><br>nasal obstruction or congestion <br/ ><br>nasal discharge <br/ ><br>nausea or vomiting <br/ ><br>diarrhea <br/ ><br>documented temperature >37.8°C <br/ ><br> <br/ ><br>Oxygenation saturation of â?¥92% obtained at rest by study staff within 48 hours prior to study entry, unless the potential participant regularly receives chronic supplementary oxygen for an underlying lung condition. <br/ ><br> <br/ ><br>Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days post-entry, whichever is earliest. â?¢Additional inclusion criteria as appropriate for the investigational agent (see relevant appendix/appendices). <br/ ><br> <br/ ><br>For participants who are of reproductive potential, negative serum or urine pregnancy test at within 48 hours prior to study entry by any clinic or laboratory that has a CLIA certification or its equivalent, or by a point of care (POC)/CLIA-waived test. <br/ ><br>If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use two forms of effective contraception, where at least one form is highly effective (less than 1% failure rate), for the entirety of the study and for 90 days after investigational agent is administered. <br/ ><br>Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male or female condoms with spermicide as well as one additional form of effective contraception with non-pregnant sexual partners of reproductive potential, for the entirety of the study and for 90 days after investigational agent is administered . <br/ ><br>as well as the appropriate inclusion for the investigational agent included below; <br/ ><br>A. Meet the protocol definition of being at → | Exclusion criteria: History of or current hospitalization for COVID-19. <br/ ><br> <br/ ><br>Current need for hospitalization or immediate medical attention in the clinical opinion of the site investigator. <br/ ><br> <br/ ><br>Use of any prohibited medication listed in section 5.4.1 within 30 days prior to study entry. <br/ ><br> <br/ ><br>Receipt of convalescent COVID-19 plasma treatment at any time prior to study entry. <br/ ><br> <br/ ><br>Receipt of a SARS-CoV-2 vaccine at any time prior to study entry. <br/ ><br> <br/ ><br>Receipt of other available investigational treatments for SARS-CoV-2 at any time prior to study entry. This does not include drugs approved for other uses and taken for those uses. <br/ ><br> <br/ ><br>Receipt of systemic steroids (e.g., prednisone, dexamethasone) or inhaled steroids within 30 days prior to study entry unless a stable dose used for a chronic condition. <br/ ><br> <br/ ><br> <br/ ><br>Known allergy/sensitivity or any hypersensitivity to components of the investigational agent or placebo. See relevant appendix. <br/ ><br> <br/ ><br>Any co-morbidity requiring surgery within 7 days prior to study entry, or that is considered life threatening in the opinion of the site investigator within 30 days prior to study entry. <br/ ><br> <br/ ><br>Additional exclusion criteria as appropriate for the investigational agent (see relevant appendix/appendices). <br/ ><br> <br/ ><br>Currently pregnant <br/ ><br> <br/ ><br>Currently breastfeeding <br/ ><br> <br/ ><br>Profile of probands: age, sex, race, health status, co-medication <br/ ><br>Male and female individuals â?¥18 years of age as detailed above. <br/ ><br> <br/ ><br>Participants must meet above inclusion and exclusion criteria from the master protocol. <br/ ><br>exclusion criteria for the investigational <br/ ><br>agent included below: . Currently pregnant or breastfeeding <br/ ><br> <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: BRII-196 and BRII-198: 1000 mg (BRII-196)/1000 mg (BRII-198) combination therapy. Administered by consecutive IV infusions as single dose<br>BRII-196 is to be administered as an intravenous infusion over no less than 25 minutes, followed by BRII-198 administered as an intravenous infusion over no less than 25 minutes.<br>Control Intervention1: Placebo in addition Standard of care<br>: Placebo for BRII-196 followed by Placebo for BRII-198: 0.9% Sodium Chloride Injection, USP to be administered as two separate infusions as a one-time dose.<br>Placebo is to be administered as an intravenous infusion over no less than 25 minutes.<br>→ | Death from any cause or hospitalization during the 28-day period from and including the day of the first dose of investigational agent or placebo. Hospitalization is defined as equal or grater than 24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19 during the COVID-19 pandemic.Timepoint: New Grade 3 or higher AE through 28 days→ | | | | Yes | False | | |
| → | CTRI/2021/05/033742 | 7 September 2021 | Study to know the efficacy of REMDESIVIR, an antiviral drug in treating Moderate and severe Covid â?? 19 Pneumonia (Lung Infection) due to CORONA virus in adult patients. | A Retrospective study of Comparing outcomes of Moderate and severe COVID-19 Pneumonia in patients treated with guideline based remdesivir regimen and non-remdesivir regimenâ?? RESCUER study - RESCUER | | Government of Tamilnadu | 24-05-2021 | 20210524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49110 | Recruiting | No | | | | 27-05-2021 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | N/A | India→ | Duraisamy Kathirvel→ | | OP no 307,
Department of Cardiology,
Government Villupuram Medical College and Hospital,
Mundiyampakkam.
Villupuram. 19/3, VDM main road,
Mangalampet,
Cuddalore district
606104→ | maestrokathir@yahoo.com→ | 9943375533→ | Government Villupuram Medical College and Hospital→ | Inclusion criteria: Age â?¥12 years with Confirmed COVID-19. (Laboratory (RT-PCR) â?? Positive) <br/ ><br>Moderate COVID pneumonia: <br/ ><br>Moderate Pneumonia (frequent fever, cough) with no obvious hypoxemia, chest CT with lesions. <br/ ><br>Severe COVID pneumonia: <br/ ><br>Severe Pneumonia with hypoxemia (SpO2 < 92%). <br/ ><br>Patients received Remdesivir (Case) and also not received it (Control group). <br/ ><br> <br/ ><br>→ | Exclusion criteria: Mild infection (without CT lesions) <br/ ><br>Critical pneumonias (CT involvement > 75%). <br/ ><br>Patients with moderate and Severe pneumonia but died within 3 days of hospital admission. <br/ ><br>Patient who received Tocilizumab (critical pts) <br/ ><br>Severe liver disease (AST > 5 times upper limit) <br/ ><br>Patients with severe renal impairment (estimated GFR â?¤30 mL/min/1.73 m2) or receiving continuous Dialysis <br/ ><br>Pregnant or breastfeeding mothers. <br/ ><br>Patient transferred to another hospital within 72 hours. <br/ ><br>Cases with inadequate datas. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Control Intervention1: REMDESIVIR: Remdesivir, usullay administered as injection at a loading dose of 200mg intravenously on Day 1 over 30 - 120 min, followed by 100mg for another 4 days for covid -19 pneumonia patients.<br><br>→ | 1. Time to clinical recovery <br/ ><br>2. All cause mortality <br/ ><br> <br/ ><br>Timepoint: one month→ | | | | Yes | False | | |
| → | CTRI/2021/05/033743 | 7 September 2021 | Study to calculate the risk of developing blood clots due to corona virus | Prospective validation of a probability calculation for venous thrombosis in patients with COVID-19 infection - VASC VTE-IU | | Christian medical college Vellore | 24-05-2021 | 20210524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45819 | Not Recruiting | No | | | | 31-05-2021 | 210 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 3/ Phase 4 | United States of America;India→ | Albert Abhinay Kota→ | | Department of Vascular Surgery, Christian medical college, Vellore → | albertkota@cmcvellore.ac.in→ | 9789360870→ | Christian medical college Vellore→ | Inclusion criteria: COVID infected patients with symptoms of limb swelling→ | Exclusion criteria: Vulnerable population including age <18 years and >8o years, pregnant women→ | Health Condition 1: I824- Acute embolism and thrombosis of deep veins of lower extremity
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | Presence of deep vein thrombosisTimepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2021/05/033744 | 7 September 2021 | Study of Remdesivir metabolism in patients with COVID-19 and kidney disease. | Pharmacokinetics of sulfobutylether-β-cyclodextrin (SBECD) and Remdesivir in patients
with severe COVID19 and kidney disease. | | Department of nephrology | 24-05-2021 | 20210524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51830 | Not Recruiting | No | | | | 01-06-2021 | 36 | PMS | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Divya Bajpai→ | | Department of Nephrology Seth G S Medical
College and KEM Hospital Mumbai 400012 → | divyaa24@gmail.com→ | 8454024014→ | Department of Nephrology→ | Inclusion criteria: 1. Patients with severe COVID19 and kidney disease [any one of the following â?? end stage kidney <br/ ><br>disease OR acute kidney injury OR kidney transplant recipients with acute graft dysfuntion. <br/ ><br>2. Patients in whom the treating physician decides to start Remdesivir as a part of standard care. <br/ ><br>3. Willing to give written, informed consent. <br/ ><br>4. Participants of either gender <br/ ><br>5. Age >18 years→ | Exclusion criteria: 1. Patients with presumed or suspected diagnosis of COVID19 <br/ ><br>2. Patients with pregnancy <br/ ><br>3. Patients with underlying liver disease [AST/ALT elevations > 5 times the upper limit of normal] <br/ ><br>4. Patients with any known allergy of reaction to Remdesivir. <br/ ><br>5. Patients requiring daily or more frequent dialysis sessions. <br/ ><br>6. Patients in the AKI or transplant catergory who require dialysis.→ | Health Condition 1: N17- Acute kidney failure
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: N186- End stage renal disease
→ | Intervention1: remdesivir: We will be checking pharmacokinetics of remdesivir. there is no comparator agent.<br>The dose is 200 mg on Day 1, followed by 100 mg for next 4 days.<br>The mode of administration is Intravenous<br>→ | To evaluate the pharmacokinetics of SBECD in adult patients with severe covid19 and kidney <br/ ><br>disease.Timepoint: 1 YEAR→ | | | | Yes | False | | |
| → | CTRI/2021/05/033750 | 7 September 2021 | Study of Favipiravir DPI in SARS-CoV-2 Infection. | Proof of concept study to evaluate the safety and effectiveness of Favipiravir DPI as an intervention in subjects with SARS-CoV-2 Infection. - Nil | | SAVA Healthcare Ltd | 24-05-2021 | 20210524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56108 | Recruiting | No | | | | 29-05-2021 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | N/A | India→ | Mr Avinaash Mandale→ | | SAVA Healthcare Ltd Research Center Block No D1 plot No 17 MIDC Chinchwad Pune India → | sriram.p@savaglobal.com→ | 7507003688→ | SAVA Healthcare Ltd→ | Inclusion criteria: 1.Age -18- 60 years (Both sex) <br/ ><br>2.Confirmed COVID 19 patient with positive RT-PCR <br/ ><br>3.Mild symptomatic or asymptomatic patients having no signs of severe disease (NEWS score â?¤6) and no comorbidity at screening <br/ ><br>4.Subject willing to provide consent and follow up for study duration <br/ ><br>→ | Exclusion criteria: 1.Patients with compromised immunity, autoimmune disease or self-reports HIV or syphilis infection <br/ ><br>2.Proves to be unfit for the study as per the investigatorâ??s discretion <br/ ><br>3.Pregnant or lactating women <br/ ><br>4.Requiring supplemental oxygen and ICU admission at screening <br/ ><br>5.Comorbidity at screening and which in investigator discretion finds subject not suitable for the trial participation <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Favipiravir DPI: Favipiravir DPI in 20 mg/ day dosage for 10 days<br>Intervention2: Favipiravir DPI: Favipiravir DPI in 10 mg/ day dosage for 10 days<br>Control Intervention1: Favipiravir oral: Favipiravir oral in prescribed dosage as per ICMR protocol for 10 days<br>→ | RT-PCR test for COVID 19- Day 5 and 10 <br/ ><br>Improvement of clinical symptoms including duration of respiratory distress, cough, sneezing and diarrhea <br/ ><br>Requirements of supplemental oxygen and SpO2 levels <br/ ><br>Reduction in elevated levels CRP, LDH, D-Dimer, Interleukin 6 and Ferritin <br/ ><br>Daily SpO2 levels from baseline to end of studyTimepoint: From baseline to day 10→ | | | | Yes | False | | |
| → | CTRI/2021/05/033752 | 7 September 2021 | COVAXIN® in paediatric study | A Phase II/III, Open Label, Multicenter Study to Evaluate the Safety, Reactogenicity and Immunogenicity of the Whole-Virion Inactivated SARS-CoV-2 Vaccine (COVAXIN®) in Healthy Volunteers ages â?¤18 to â?¥ 2 Years - COVAXIN | | Bharat Biotech International Limited | 24-05-2021 | 20210524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56105 | Recruiting | No | | | | 26-05-2021 | 525 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr V Krishna Mohan→ | | Bharat Biotech International Limited
Genome valley Shameerpet Hyderabad → | kmohan@bharatbiotech.com→ | 914023480567→ | Bharat Biotech International Limited→ | Inclusion criteria: 1. Ability to provide written informed consent (by the parents or legally acceptable/authorized representative (LAR) and assent by the children (verbal/oral assent for the children of age between 7-12 years, and written assent for the children of age between >12 to 18 years), and Audio video consent for all participants. <br/ ><br>2. Participants of either gender of age between â?¥2 to â?¤18years (Participant should be â?¤18 years at the time of Screening of the study). <br/ ><br>3. Good general health as determined by the discretion of investigator. <br/ ><br>4. Expressed interest and availability to fulfill the study requirements. <br/ ><br>5. Agrees not to participate in another clinical trial at any time during the study period. <br/ ><br>6. Agrees to remain in the study area for the entire duration of the study. <br/ ><br>7. Willing to allow storage and future use of biological samples for future research <br/ ><br>→ | Exclusion criteria: 1. History of any other COVID-19 investigational vaccination. <br/ ><br>2. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method. <br/ ><br>3. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ ><br>4. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrollment or expects to receive an investigational agent during the study period. <br/ ><br>5. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ ><br>6. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ ><br>7. Receipt of immunoglobulin or other blood products within the three months prior to vaccination in this study. <br/ ><br>8. Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. <br/ ><br>9. Long-term use ( >2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed). <br/ ><br>10. Any history of hereditary angioedema or idiopathic angioedema. <br/ ><br>11. Any history of anaphylaxis in relation to vaccination. <br/ ><br>12. History of congenital diseases. <br/ ><br>13. Any history of albumin-intolerance. <br/ ><br>14. History of any cancer. <br/ ><br>15. History of psychiatric severe conditions likely to affect participation in the study. <br/ ><br>16. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venepuncture. <br/ ><br>17. Any other serious chronic illness requiring hospital specialist supervision. <br/ ><br>18. Respiratory diseases like severe acute respiratory syndrome (SARS), including mild- moderate asthma. <br/ ><br>19. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder, and neurological illness. <br/ ><br>20. History of SARS-CoV-2 infection or known close contact with anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior to vaccine administration. <br/ ><br>21. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. <br/ ><br>Re-Vaccination Exclusion Criteria <br/ ><br>22. Anaphylactic reaction following administration of the investigational vaccine. <br/ ><br>23. Virologically confirmed cases of COVID-19 through nucleic acid tests <br/ ><br>→ | | Intervention1: BBV152: 0.5 ml administered intramuscular at day 0 and day 28<br>Control Intervention1: NA: NA<br>→ | 1 Occurrence of immediate adverse events within two hours of vaccination <br/ ><br>2 Occurrence of solicited local and systemic adverse events within 7 days after vaccination and unsolicited adverse events within 28 days after vaccination. <br/ ><br>3 Occurrence of Serious Adverse Events throughout the study duration. <br/ ><br>4 Occurrence of Adverse Events of Special Interest (AESI) throughout the study duration <br/ ><br>5 To evaluate the GMTs and seroconversion of COVAXIN®Timepoint: Day 28±2, 56±7, 118±7 and 208±7→ | | | | Yes | False | | |
| → | CTRI/2021/05/033771 | 7 September 2021 | Usefulness of Pulsed Inhaled Nitric OXide (iNO) in adults with asymptomatic or mildly symptomatic COVID patients without pre-existing illness. | Efficacy of Pulsed Inhaled Nitric OXide (iNO) in adults with asymptomatic or mildly symptomatic COVID patients without co-morbidities (EPINOX study). A single centre, academic, prospective, case control, non-randomized, open labelled, interventional, comparative study - EPINOX | | Sir h n Reliance Foundation hospital and research centre | 24-05-2021 | 20210524 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56263 | Recruiting | No | | | | 30-05-2021 | 250 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Niranjan Waje→ | | Department of Anesthesia
Sir H N Reliance Foundation Hospital,
Raja Ram Mohan Roy Road, Prarthana Samaj. Girgaum
Mumbai
Raja Ram Mohan Roy Road, Prarthana Samaj. Girgaum
Mumbai 400004
→ | rfh.academics@rfhospital.org→ | 26135326→ | Sir H N Reliance Foundation Hospital and Research Centre→ | Inclusion criteria: Adults, 18 â?? 50 years(account for 60% of cases in India as on May 6, 2021), with positive rtPCR and consenting to the study within 48 hours of diagnosis, already admitted or willing to get admitted to the COVID facility at SevenHills Hospital, managed by Sir H N Reliance Foundation Hospital, with asymptomatic or mildly symptomatic symptoms.→ | Exclusion criteria: A.Comorbid factors: <br/ ><br>1. Smoker <br/ ><br>2. Hypertension or hypotension <br/ ><br>3. Diabetes Mellitus <br/ ><br>4. Renal injury or failure <br/ ><br>5. Known abnormal Haemoglobinopathies <br/ ><br>6. Known clinically significant Pulmonary Arterial Hypertension <br/ ><br>7. Known congenital heart disease operated or otherwise <br/ ><br>8. Heart Failure (LVF <40%) <br/ ><br>B.Other factors: <br/ ><br>1. Additional treatment with Steroids, Tocilizumab, Plasma therapy. <br/ ><br>2. Requiring supplemental oxygen to maintain saturations > 93% <br/ ><br>3. Needing intubation and mechanical ventilation <br/ ><br>4. Past history of documented COVID-19 infection <br/ ><br>5. Completed COVID vaccination. <br/ ><br>6. Pregnant women, confirmed or suspected <br/ ><br>7. Mentally or neurologically disabled patients who are considered not fit to <br/ ><br> consent to their participation in the study <br/ ><br>8. Current smoker - Current smokerâ?? is someone who has smoked greater than 100 <br/ ><br> cigarettes in their lifetime and has smoked in the last 28 days. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: pulsed inhaled nitric oxide: Administer pulsed inhaled nitric oxide at 160 ppm for 30 mins once a day for 5 days<br>Control Intervention1: Room air: Subjects who shall not be administered inhaled nitric oxide with same set of inclusion and exclusion criteria<br>→ | 1. Number of days to negative rtPCR or decrease viral load reflected in the ct values 35 <br/ ><br>2. Number of patients in room air progressing to O2 supplementation, or further advanced <br/ ><br> medications or ventilation in first 10 days. <br/ ><br>3. Reduction in number of hospital days <br/ ><br>4. Reduction in Morbidity and mortality. <br/ ><br>Timepoint: 3 months trial and data collection <br/ ><br>3 months data analysis→ | | | | Yes | False | | |
| → | CTRI/2021/05/033787 | 7 September 2021 | TO STUDY THE TYPE OF DELIVERY AND ILLNESSES IN COVID POSITIVE MOTHERS | TO STUDY THE MODE OF DELIVERY AND MATERNAL MORBIDITY IN TERM COVID POSITIVE PATIENTS. | | GCS Medical College Hospital and Research center | 25-05-2021 | 20210525 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56103 | Not Recruiting | No | | | | 31-05-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dholakiya Saksha Nareshbhai→ | | Department of Obstetrics and Gynaecology, GCS Medical College Hospital and Research Center , Asarwa , Ahmedabad Department of Obstetrics and Gynaecology→ | drpsomesh03@yahoo.co.in→ | 7984366414→ | GCS Medical College Hospital and Research Center→ | Inclusion criteria: All pregnant women.→ | Exclusion criteria: Non-pregnant women.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: nil: nil<br>→ | Cesarean DeliveriesTimepoint: 18 months→ | | | | Yes | False | | |
| → | CTRI/2021/05/033790 | 7 September 2021 | Efficacy of Ayush medicine NOQ19 in treatment of Covid-19 patients | A randomized, double blind, placebo controlled, multi-centric, trial to determine the therapeutic efficacy of Ayush medicine NOQ19 in treatment of symptomatic COVID-19 patients along with standard allopathic treatment | | Sriveda Sattva Private Limited Sri Sri Tattva | 25-05-2021 | 20210525 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56306 | Not Recruiting | No | | | | 31-05-2021 | 360 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | Dr Naveen K H→ | | Dept. of Community Medicine and Family Medicine, AIIMS → | pankajbhardwajdr@gmail.com→ | 8003996903→ | AIIMS→ | Inclusion criteria: Symptomatic COVID 19 infection with or without comorbidities <br/ ><br>Willingness to participate in the study <br/ ><br>Indian nationals <br/ ><br>→ | Exclusion criteria: Age less than 18 years or more than 65 years <br/ ><br>Pregnancy and Lactation <br/ ><br>Patient not willing to participate in the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayurveda Medicine NOQ 19: 500 mg , 2tabs thrice daily orally with water in morning, Noon and Night.<br>Duration of therapy: 7 days<br>Control Intervention1: Placebo: 500 mg , 2tabs thrice daily orally with water in morning, Noon and Night. <br>Duration of placebo: 7 days<br>→ | To evaluate the effect of NOQ19 in COVID 19 patients in time to become SARS COV2 RT-PCR negative, reducing the symptoms and duration of hospital stayTimepoint: 7 days for each participant→ | | | | Yes | False | | |
| → | CTRI/2021/05/033791 | 7 September 2021 | A Clinical Trial Evaluating Niclosamide for the Treatment of Covid-19 Disease. | A Multicentric Phase II Randomized Open Label Clinical Study to Evaluate Efficacy Safety and Tolerability of Niclosamide for the Treatment of Hospitalized Corona Virus Disease (COVID-19) Patients - NICOVID | | Laxai Life Sciences Pvt Ltd | 25-05-2021 | 20210525 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55471 | Recruiting | No | | | | 01-06-2021 | 96 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Open Label | Phase 2 | India→ | Dr R M Chhabra→ | | Insignia Clinical Services Pvt. Ltd. Room # 512, Clinical Trial Division, Clinical Operations Department, Best Sky Tower, Netaji Subhash Place, Pitampura North West Delhi, India Not Applicable→ | Chhabradrrm@gmail.com→ | 011-49049115→ | Insignia Clinical Services Pvt. Ltd.→ | Inclusion criteria: Male & female (non-pregnant, non-lactating, post-menopausal, surgically sterilized, or practicing a reliable <br/ ><br>method of birth control during the duration of the study) patients with ages ranging from 18 to 65 years (both inclusive). <br/ ><br> <br/ ><br>Clinically stable condition for at least 6 months before enrollment. <br/ ><br> <br/ ><br>Confirmed diagnosis of moderate COVID-19 symptoms demonstrated by: <br/ ><br> <br/ ><br>Positivity in RT-PCR 2019-nCov test on respiratory tract (nasopharyngeal / oropharyngeal) specimens. <br/ ><br> <br/ ><br>Presence of dyspnea and/or hypoxia, fever, cough, including SpO2 < 93% (range 90-93%) on room air, Respiratory Rate > 24 and < 30 breaths per minute. Patients with SpO2 < 90% to be excluded from the study. <br/ ><br> <br/ ><br>Signs of pneumonia (lung injury/lung involvement) confirmed by Chest X-Ray at the time of study entry. <br/ ><br> <br/ ><br>Disease severity score between Grade 4 to 5 on the WHO 9-point ordinal scale & patient requires <br/ ><br>hospitalization for management of the disease. <br/ ><br> <br/ ><br>Within 7 days from symptom onset or within 72 hours of laboratory diagnosis of SARS-CoV2 via RT-PCR test. <br/ ><br> <br/ ><br>Able to take oral tablets at the time of study entry and agree not to participate in any other study for <br/ ><br>duration of participation in this study. <br/ ><br> <br/ ><br>Willing to sign voluntary informed consent for participation in the study and willing to adhere to all protocol procedures. In case the subject is unable to provide informed consent then the same should be obtained from a legally acceptable representative (LAR). <br/ ><br>→ | Exclusion criteria: Subjects will be excluded from the study for any of the following reasons: <br/ ><br> <br/ ><br>Subjects with known allergy or hypersensitivity to Niclosamide or any of its components. <br/ ><br> <br/ ><br>Patients who have previously had a disease severity score of 6 or 7 on the WHO 9-point ordinal scale. <br/ ><br> <br/ ><br>Evidence of severe or critical illness, defined by at least 1 of the following: <br/ ><br> <br/ ><br>Respiratory failure requiring at least 1 of the following: <br/ ><br> <br/ ><br>Endotracheal intubation and mechanical ventilation, oxygen delivered by high flow nasal cannula <br/ ><br> <br/ ><br>Extracorporeal membrane oxygenation (ECMO) or clinical diagnosis of respiratory failure <br/ ><br> <br/ ><br>Shock (defined by systolic blood pressure (BP) <100 mm Hg, or diastolic blood pressure (BP) <60 mm Hg or requiring vasopressors), <br/ ><br> <br/ ><br>OR <br/ ><br> <br/ ><br>Multi-organ dysfunction/failure <br/ ><br> <br/ ><br>Subjects with Chronic liver disease (Child-Pugh class B or C) and chronic renal disease (GFR <30ml/min). <br/ ><br> <br/ ><br>Renal dysfunction [Serum Creatinine > 2.5 times of ULN or calculated creatinine clearance < 30ml/min], Liver Dysfunction [Total Bilirubin > 3times ULN & AST/ALT >5times ULN]. <br/ ><br> <br/ ><br>Subjects with oxygen saturation (SpO2) â?¤90%. <br/ ><br> <br/ ><br>Respiration Rate â?¥30 breaths per minute at the time of enrolment. <br/ ><br> <br/ ><br>History of refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug, or having undergone extensive bowel resection which may affect adequate absorption of study medications. <br/ ><br> <br/ ><br>Inability to swallow tablets (administration via nasogastric tube is permitted in patients who become unable to swallow after starting the study drug). <br/ ><br> <br/ ><br>Patients who require IL-6 inhibitors for management of inflammation at the time of study entry. <br/ ><br> <br/ ><br>Female subjects who are pregnant or involved in breastfeeding. <br/ ><br> <br/ ><br>Subject was using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists, or interleukin receptor blockers) within one week prior to study entry. <br/ ><br> <br/ ><br>Subject has a serious chronic disease (e.g., human immunodeficiency virus (HIV), hepatitis B virus or hepatitis C virus, cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days. <br/ ><br> <br/ ><br>Has a history of alcohol or drug abuse in the previous 6 months. <br/ ><br> <br/ ><br>Subject has a psychiatric disease that is not well controlled where controlled is defined as stable on a regimen for more than one year. <br/ ><br> <br/ ><br>Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ ><br> <br/ ><br>Hospital discharge is anticipated in â?¤24 hours. <br/ ><br> <br/ ><br>Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ ><br> <br/ ><br>Participated in any other clinical trial or taken an investigational drug within 1 month. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J988- Other specified respiratory disorders
→ | Intervention1: Niclosamide 2000 mg orally Plus Standard of Care: Niclosamide 2000 mg orally Plus Standard of Care<br>Treatment Duration for 07 Days<br>Control Intervention1: Standard Of Care: Standard Of Care<br>→ | Time to Clinical Improvement of 2-points on WHO 8-Point Ordinal Scale <br/ ><br>Timepoint: Baseline, Day 03, Day 05, Day 07, Day 14, Day 21→ | | | | Yes | False | | |
| → | CTRI/2021/05/033793 | 7 September 2021 | Online Yoga for Managing Covid-19 Induced Psychological Problems | Online Yoga Intervention as Tertiary Prevention of Psychological Comorbidities of Covid-19 Survivors - OYITPPCCOVID | | Patnajli Ayurved Hospital | 25-05-2021 | 20210525 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56160 | Not Recruiting | No | | | | 01-07-2021 | 66 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Dr Velan→ | | University of Patanjali,
Department of Yoga Science
Room No: 421, Patanjali Ayurved College
Patanjali Yogpeeth
Phase-1, Haridwar University of Patanjali,
Department of Yoga Science
Room No: 421, Patanjali Ayurved College
Patanjali Yogpeeth
Phas-1, Harid→ | rbap@uop.edu.in→ | 9634510540→ | University of Patanjali→ | Inclusion criteria: 1)An email address, an internet-connected computer with camera and sound system/ tablet or 4G and/or Wi-Fi enabled Smartphone (running Google chrome). <br/ ><br> <br/ ><br>2)Symptomatic medical history of at least 2 month back and BDI Scoreâ?¥10 or Hamilton Anxiety Scale Score greater than or equal to 17. <br/ ><br> <br/ ><br>3)Faith on mind body practices and Ayurveda, no involvement in other exercises and interest for voluntary participation in the study. <br/ ><br>→ | Exclusion criteria: Participants with medical health issues as under before the onset of clinical symptoms of Covid-19 infection: <br/ ><br>Neurological, hypertension, diabetes mellitus, Cardiovascular disease, renal complications, liver disorders, locomotors disabilities, glaucoma, hernia, ulcers of the stomach or intestine, recent abdominal or spinal surgery, pregnancy/lactating phase, addictive behaviors (smoking, alcoholism, tobacco chewing) and age below 15 and above 60 years.→ | Health Condition 1: F063- Mood disorder due to known physiological condition
→ | Intervention1: Online Yoga Intervention: 22 participants are expected to go through one-month online yoga classes (5 classes/week) by covering the yogic practices as mentioned in yoga protocol.<br>Asanas<br><br>Loosening and Energing Series (LES):Toes stretch, ankle stretch, ankle rotation, knee stretches, knee rotation, half butterfly, hip joint stretch and rotation, semi spinal twists with extended legs, fingers stretches from middle and distal phalangeal joints, palm stretches, wrist stretches and rotations, shoulder stretches and rotations, neck movements: up-down, sidewise- tilts and twists, rotation, chest opening, spinal stretch, hands rotation from shoulders, facial movements- protraction, retraction, clinching, grinding teeth <br>Pranamasana(Prayers pose)<br>Tadasana (Palm Tree Pose)<br>Padhastasana (Head to Toe Pose), Ustrasana (Camal Pose)<br>Utkatasana (Chair pose)<br>Yogmudrasana(Rabbit pose with hands extended back with interlocked fingers)<br>Ardhatadasana(Semi Palm Tree Pose)<br>Bhujangasana (Cobra pose)<br>Shalabhasana (Locust pose)<br>Vakrasana(Seated Semi Spinal Twist)<br>Vajrasana (Thunderbolt pose)<br>Makarasana (Crocodile Pose)<br><br>Note: Practice of the aforesaid poses will be synchronized with breathing patterns and mental awareness by caring patients comfort limits. <br><br><br>Breathing practices<br><br>Uni-nostril Breathing (UNB)<br>Alternate Nostril Breathing (ANB)<br>Kapalbhati<br>Bhastrika<br>Kapol Shakti Vikasak(KSV) (Crown Breathing)<br>Ujjayai.<br>Bhramari<br><br>Mudras: Gyan, Sanmukhi, Prana, and Apana.<br><br>Bandhas: Mool, Jalandhar, and Uddiyan<br><br>Note: Breathing practices will be synchronized with specified Mudras and Bandhas.<br><br>Savita Dhyan (meditation of rising sun).<br><br>Attmabodha and Tattwabodh. <br><br>Nadyog- Durga Rag and Prayer<br><br><br><br>Intervention2: Yoga cum Herbal Concoction: 22 Participants are expected to go through online yog→ | 1)Proposed OYI with and without herbal concoction is expected to improve the PTSD, Anxiety, Depression and Quality of Life of COVID-19 survivors in Experimental groups as compared to the controls. <br/ ><br> <br/ ><br>2)If this OYI protocol proves to be effective, then it may be a good option for over millions global COVID-19 survivors to overcome comorbidities, boost immunity and restore health. <br/ ><br>Timepoint: Staff Recruitment & training: 01-15 July 2021 <br/ ><br>Recruitment of Participants, Randomization: 15 July- 15 August 2021 <br/ ><br>Baseline scoring of instruments: 15-30 August 2021 (4 weeks) <br/ ><br>Final scoring of instruments after intervention: 01-05 September 2021 (one week) <br/ ><br>Data Entry and Analysis: 15-30 September 2021 <br/ ><br>Compilation of annual report: October-November 2021 <br/ ><br> <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/05/033799 | 7 September 2021 | To study the effect of steroid use during treatment of severe Covid 19 on steroid axis function during 6 month post covid period. | Study to evaluate Hypothalamo Pituitary Adrenal axis during 6 months post Covid period - HPA PC | | Prof Dr Jayanthy Ramesh | 25-05-2021 | 20210525 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56059 | Not Recruiting | No | | | | 31-05-2021 | 60 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shyam Sundar C M→ | | Department of Endocrinology,
Superspeciality Block, KGH Campus, Maharanipeta → | drjayanthyramesh@gmail.com→ | 7674025445→ | Andhra Medical College→ | Inclusion criteria: diagnosed moderate or severe Covid 19 by RTPCR or Rapid Antigen Test(RAT) or HRCT thorax, admitted, treated and discharged from CSR Block, King George Hospital. <br/ ><br>Those patients who were hospitalised and have received steroid treatment for less than 14days. <br/ ><br>Those who give consent to participate in the study <br/ ><br>→ | Exclusion criteria: Pregnant individuals <br/ ><br>Patients receiving glucocorticoids for any indication prior to hospital admission <br/ ><br>K/c/o primary/secondary adrenal insufficiency/ cortisol excess states <br/ ><br>Patients with Chronic kidney disease, Chronic liver disease, Coronary artery disease , Cerebrovascular accident <br/ ><br>Smokers/ Chronic alcoholism <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Hypothalamo pituitary axis suppression, demonstrated by <br/ ><br> ACTH stimulated cortisol less than 18 mcg/dlTimepoint: 3 months and 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/05/033816 | 7 September 2021 | Yoga & naturopathy-based telemedicine as an adjuvant therapy in improving quality of life and alleviating anxiety and depression in mild to moderate COVID-19 positive patients | Yoga & naturopathy-based telemedicine as an adjuvant therapy in improving quality of life and alleviating anxiety and depression in mild to moderate COVID-19 patients who are in home quarantine. A non-randomized control trial - YONAC-19 | | Dr Pradeep MK Nair | 27-05-2021 | 20210527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56233 | Not Recruiting | No | | | | 29-05-2021 | 100 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Pradeep MK Nair→ | | Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for women
Department of Research
Room no 9
Yoga and Naturopathy Division
Sant Hirdaram Nagar
Bhopal 462030 → | director@iaswar.com→ | 9823262179→ | Sant Hirdaram Medical College of Naturopathy and Yogic Sciences for women→ | Inclusion criteria: All positive mild and moderate COVID-19 cases who are receiving standard care and are in home quarantine. <br/ ><br>Patients willing to consent to participate in the study→ | Exclusion criteria: All positive mild and moderate COVID-19 cases who are in hospital care <br/ ><br>Patients who require supplemental oxygen therapy <br/ ><br>Pregnant and lactating mothers <br/ ><br>Patients who are under 18 years of age→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Yoga and naturopathy Home remedies: Yogasanas:<br>1. Hand in and out breathing 5 rounds â?? 1 minute<br>2. Hand stretch breathing â?? 10 rounds 2 mins<br>3. Skanda chalasana ( shoulder rotation) â?? 5 rounds â?? 3 minutes<br>4. Gomukhasana â?? 1 round 1 minute<br>5. Makarasana â?? 1 minute 1 round. (note: if there is any difficulty in breathing, change to a comfortable posture immediately)<br><br>Pranayama: <br><br>1. Vibhagiya pranayama- 5 rounds â?? 3minutes<br>2. Nadishuddhi â?? 10 -15 rounds (internal breath retention for 5 seconds)<br>3. Bhramari pranayama â?? 10 -15 rounds ( Note: U can do it according to your capacity. DO NOT STRAIN, but repeat it after sometime)<br>4. Guided meditation or deep relaxation technique (YouTube link will be sent). Do it in a comfortable posture.<br><br>Naturopathy Diet: <br><br>1. Easily digestible food. (vegetable soups, khichdi, jowar/ bajra/ red rice/ single polished rice with boiled vegetable with added mild spices â?? jeera,dhania powder, hing, ginger, garlic ( crushed 1 pod), chat masala, black pepper (1 pinch), jaljeera with luke warm water after food.<br>2. Saunf - less than ¼ tsp after food ( 3times a day)<br>3. Ajwain ka kadha - 150ml of water + 1/4 tsp of ajwain + jaggery 1/4 tsp - boil it on low flame for 10mins. Consume it 100ml 1/2 an hour before food. ( 3 times a day)<br>4. Steam inhalation â?? 2 drops of eucalyptus oil and ajwain 1 pinch â?? 2 â?? 3 times per day<br>5. Apply eucalyptus oil on the back and chest region before going to bed. And inhale the same fragrance for 5 minutes.<br>6. Acupressure<br>In addition to this the patients will be continuing with their standard of care interventions as per ICMR protocols. The total duration of yoga therapy will be for 45 mins daily for 14 days. Other dietary advises will be given one time at the baseline as a part of da→ | Reduction in Anxiety and depression assessed by DASS 21 scale, improvement in QOL assessed by WHO-Bref, Improvement in symptomsTimepoint: At baseline Baseline <br/ ><br>Anxiety and depression assessed by DASS 21 scale, Quality of Life assessed by WHO-BREF <br/ ><br>At 14th Day from baseline <br/ ><br>Anxiety and depression assessed by DASS 21 scale, Quality of Life assessed by WHO-BREF→ | | | | Yes | False | | |
| → | CTRI/2021/05/033817 | 7 September 2021 | Use of Steroid inhalers in COVID. | â??Treating COVID-19 infection with inhaled corticosteroids - STOIC 2 | | YOU BREATHE WE CARE | 27-05-2021 | 20210527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48544 | Not Recruiting | No | | | | 30-05-2021 | 820 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Raja Dhar→ | | CK Birla Hospitals
Pulmonology speciality clinic,
Level 1,
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road,Kolkata → | pulmoresearch@gmail.com→ | | | Inclusion criteria: 1.Participant is willing and able to give informed consent <br/ ><br>2.Male or Female aged 18 years or above <br/ ><br>3.New onset of symptoms suggestive of COVID19 like new onset cough fever, loss of smell or taste within 7 or fewer days of participant being seen at visit 1 <br/ ><br>4.Able and willing to comply with all trial requirements as per Investigator→ | Exclusion criteria: 1.A known allergy to IMP <br/ ><br>2. Any known contraindication to IMP <br/ ><br>3. Patient currently prescribed inhaled or systemic corticosteroids <br/ ><br>4.Recent use, within the previous 7 days of inhaled or systemic corticosteroids <br/ ><br>5. Patient needs hospitalisation at time of study consent <br/ ><br>6. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participantâ??s ability to participate in the trial. <br/ ><br>7. Participants who have participated in another research trial involving an investigational product in the past 12 weeks→ | Health Condition 1: B338- Other specified viral diseases
→ | Intervention1: Budesonide dry powder inhaler: 400 mcg budesonide inhaler. Two puffs twice a day up to twenty eight days<br>Control Intervention1: Usual care: Care of COVID-19 as per local guidelines<br>→ | Hospitalisation or emergency department attendance related to COVIDTimepoint: Day zero to day twenty eight→ | | | | Yes | False | | |
| → | CTRI/2021/05/033818 | 7 September 2021 | Adverse skin reactions to face-masks during COVID-19 pandemic | Adverse skin reactions to face-masks during COVID-19 pandemic | | Priya Dsouza | 27-05-2021 | 20210527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50387 | Not Recruiting | No | | | | 01-06-2021 | 50 | Observational | Cluster Randomized Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Priya Dsouza→ | | Department of dematology,venereology and leprosy,6th floor
Father muller medical college, father muller road, kankanady, mangalore → | jacimartis18@gmail.com→ | 9845148112→ | Father muller medical college→ | Inclusion criteria: Patients willing for the study, Healthy participants using a face mask with no history of skin diseases <br/ ><br>→ | Exclusion criteria: Patients less than 18years of age <br/ ><br>Patients who are not willing for the study. <br/ ><br>Patients with preexisting skin conditions <br/ ><br>Patients on topical treatment with steroids, immunomodulators during one month before inclusion and during the study and on phototherapy <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: L00-L99- Diseases of the skin and subcutaneous tissue
→ | Intervention1: NIL: NIL<br>→ | cutaenous findings related to face maskTimepoint: single visit→ | | | | Yes | False | | |
| → | CTRI/2021/05/033828 | 7 September 2021 | Outcomes of Gynecological cancer surgery in patients recovered from COVID -19 infection | Gynecological cancer surgery following recovery from COVID-19 infection: An Observational study(COSGO) - COSGO | | None | 27-05-2021 | 20210527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56282 | Not Recruiting | No | | | | 01-06-2021 | 30 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Biswajit Dash→ | | Room No. 53, Ground Floor (Gynaec OPD), Homi Bhabha Building, Tata Memorial Hospital, Mumbai-400012 → | drbiswajitdash123@gmail.com→ | 91-8895331662→ | Tata Memorial Centre→ | Inclusion criteria: The following patients will be included: <br/ ><br>-The patients who have recovered from a COVID 19 infection and undergoing elective or emergency gynaecological cancer surgery excluding minor OT procedures done at TMH and ACTREC, Mumbai will be included. <br/ ><br>-The previous diagnosis of COVID 19 would be based on positive COVID-19 lab test. <br/ ><br>-Definition of COVID 19 positive: test positive [either the test undergone at Tata Memorial Hospital (TMH) or any centre outside TMH with reports] <br/ ><br>-Definition of COVID 19 negative : â??Test negativeâ?? at TMH/ACTREC. <br/ ><br> <br/ ><br>-Duration from COVID test: When the patient is COVID 19 negative and fit for surgery as per hospital protocol (generally patients undergo surgery 2 to 4 wks when COVID 19 test is negative). <br/ ><br> <br/ ><br>-The test is as per recommendations by National task force (ICMR) on COVID 19 during that period. As per the current ICMR advisory on strategy for COVID â?? 19 testing in India (Version VI, dated 04/09/2020), the current recommended tests are RT-PCR or TrueNat or CBNAAT, Rapid Antigen Test (RAT). <br/ ><br>-Definition of recovery: COVID 19 test negative and considered fit to undergo surgery. <br/ ><br> <br/ ><br>The study group would consist of recovered COVID 19 positive patients fit for surgery (Test negative at present, and fit for surgery).They had a past history of COVID 19 positivity ( Test positive at TMH / non-TMH) but currently, they are tested negative at TMH and fit for surgery. <br/ ><br>The control group would consist of COVID 19 Negative patients( Test negative at TMH/ACTREC) fit for surgery and without any past history of COVID 19 positivity. <br/ ><br> <br/ ><br>Consent will be obtained from both the study group and Control group patients included in the study. <br/ ><br> <br/ ><br>→ | Exclusion criteria: The COVID 19 Positive patients undergoing /undergone surgery(those who were Test positive at the time of surgery) will be excluded from the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C579- Malignant neoplasm of female genital organ, unspecified
→ | Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br>→ | 30 and 90-day mortality/morbidity(DindoClavein grade I-V)Timepoint: 30 and 90-days after surgery→ | | | | Yes | False | | |
| → | CTRI/2021/05/033833 | 7 September 2021 | An observational Study To Assess The Impact of COVID-19 Lockdown On Mental Health Of Children aged 9-12 years in School Of Scholars ,Hingna, Nagpur | A Cross Sectional Study To Assess The Impact of COVID-19 Lockdown On Mental Health Of Children aged 9-12 years in School Of Scholars ,Hingna, Nagpur | | Datta meghe Ayurved Medical College Hospital And Research Centre | 27-05-2021 | 20210527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54389 | Not Recruiting | No | | | | 05-06-2021 | 600 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Yogita Shrivas→ | | Datta Meghe Ayurvedic Medical College Hospital and Research Centre,Wanadongri, Hingna, Nagpur,
MS Datta Meghe Ayurvedic Medical College Hospital and Research Centre,Wanadongri, Hingna, Nagpur,
MS→ | yogitashrivas@yahoo.co.in→ | 7588747496→ | Datta Meghe Ayurvedic Medical College Hospital and Research Centre, Nagpur→ | Inclusion criteria: Children studying in fouth,fifth and sixth standards during the conduct of study→ | Exclusion criteria: Children below 9 years of age and above 12 years of age→ | | | The expected outcome is that the lockdown had an impact on mental health of childrenTimepoint: baseline→ | | | | Yes | False | | |
| → | CTRI/2021/05/033834 | 7 September 2021 | A Preventive Clinical trial against COVID-19 in Healthy Individuals | A Phase 2/3, Prospective, Randomized, Stratified, Observer-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Homeopathic SARS-CoV-2 Nosode (BioSimCovex) against COVID-19 In Healthy Individuals. | | Biosimilia Pvt Ltd | 27-05-2021 | 20210527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55789 | Recruiting | No | | | | 07-06-2021 | 3000 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 2/ Phase 3 | India→ | Pravinkumar Pal→ | | Office No. 103, First Floor, Raheja Arcade, Plot No 61, Sector 11, CBD Belapur, Navi Mumbai → | drajay.m@clinicaresearch.com→ | 02249705627→ | CLINICA Research Solutions LLP→ | Inclusion criteria: 1. A written signed and dated informed consent from subjects and/or legally acceptable representative. <br/ ><br>2. Either gender of age between 18 and 65 years (both inclusive) <br/ ><br>3. Subject not tested positive for SARSCoV2 virus infection (Individuals not detected with COVID 19 antibodies (Both IgG and IgM) at screening and negative with RT-PCR test as well) <br/ ><br>4. Able to comply with study procedures based on the assessment of the Investigator. <br/ ><br>5. Asymptomatic subjects (no symptoms of fever, cough, breathlessness in the previous 7 days). <br/ ><br>6. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. <br/ ><br>7. Healthy adults or adults with pre-existing medical conditions who are in stable condition. <br/ ><br>A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. <br/ ><br>8. Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for â?¥ 12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status. <br/ ><br>9. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: <br/ ><br>a. Has a negative pregnancy test at Screening and on the day of randomization (Day 1). <br/ ><br>b. Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior randomization (Day 1). <br/ ><br>c. Has agreed to continue adequate contraception through 3 months following the last dose. <br/ ><br>d. Adequate female contraception is defined as consistent and correct use of a Food and Drug Administration (FDA) approved contraceptive method in accordance with the product label. For example: <br/ ><br>e. Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction with spermicide <br/ ><br>f. Intrauterine device <br/ ><br>g. Prescription hormonal contraceptive taken or administered via oral (pill), transdermal (patch), subdermal, or IM route <br/ ><br>h. Sterilization of a female participantâ??s monogamous male partner prior to entry into the study <br/ ><br> <br/ ><br>Note: Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. <br/ ><br>i. Is not currently breast feeding. <br/ ><br>→ | Exclusion criteria: Approximately 3000 heathy participants will be enrolled in two parts; first part will have a set of 200 subjects in phase 2 and the second part will be a continuation of the study for completion of total 3000 subjects in phase 3 (200 in Phase 2+ 2800 in Phase 3). All consenting adults, irrespective of gender and who have not been tested positive for SARS- CoV2 virus infection may be enrolled in the study, considering the specifications of the inclusion and exclusion criteria. <br/ ><br> <br/ ><br>Those who are tested positive for SARS-CoV2 virus infections before enrollment shall not be subjects in this study. Any subject in the study, tested positive for SARS-CoV2 virus infection within 7 days of enrolment in the study, shall cease to be considered as a subject of the study. However, a person developing flu and cold like symptoms will continue to participate in the study if not tested positive for COVID-19. <br/ ><br> <br/ ><br>Eligibility of subject for inclusion in the study will be as per the Inclusion and Exclusion Criteria mentioned in Section 9.2.1 and Section 9.2.2. Demographic characteristics, complete medical and surgical history, vital signs, physical examination. <br/ ><br> <br/ ><br>Inclusion criteria: <br/ ><br>1. A written signed and dated data sharing informed consent from subjects and/or legally acceptable representative. <br/ ><br>2. Either gender of age between 18 and 65 years (both inclusive) <br/ ><br>3. Subject not tested positive for SARSCoV2 virus infection (Individuals not detected with COVID 19 antibodies (Both IgG and IgM) at screening and negative with RT-PCR test as well) <br/ ><br>4. Able to comply with study procedures based on the assessment of the Investigator. <br/ ><br>5. Asymptomatic subjects (no symptoms of fever, cough, breathlessness in the previous 7 days). <br/ ><br>6. Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. <br/ ><br>7. Healthy adults or adults with pre-existing medical conditions who are in stable condition. <br/ ><br>A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. <br/ ><br>8. Female participants of nonchildbearing potential may be enrolled in the study. Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea for â?¥ 12 consecutive months prior to Screening without an alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured at the discretion of the investigator to confirm postmenopausal status. <br/ ><br>9. Female participants of childbearing potential may be enrolled in the study if the participant fulfills all the following criteria: <br/ ><br>â?¢ Has a negative pregnancy test at Screening and on the day of randomization (Day 1). <br/ ><br>â?¢ Has practiced adequate contraception or has abstained from all activities that could result in pregnancy for at least 28 days prior randomization (Day 1). <br/ ><br>â?¢ Has agreed to continue adequate contraception through 3 months following the last dose. <br/ ><br>â?¢ Adequate female contraception is defined as consistent and correct use of a Food and Drug Administration (FDA) approved contraceptive method in accordance with the product label. For example: <br/ ><br>â?¢ Barrier method (such as con→ | | Intervention1: BioSimCovex Nosode: Six pills two times daily for 3 consecutive days by oral (sub-lingual). <br> <br>Repeat dose in biomarker cohort of subset of 45: Six pills two times daily for 3 consecutive days by oral (sub-lingual).<br>Control Intervention1: Placebo Oral Pills. Each Pill shall consist of globules size 30, moistened with 90% v/v ethanol: Six pills two times daily for 3 consecutive days by oral (sub-lingual). Repeat dose in biomarker cohort of subset of 45: Six pills two times daily for 3 consecutive days by oral (sub-lingual).<br>→ | 1.Efficacy of BioSimCovex to prevent the first occurrence of COVID-19 starting 14 days after the last dose of investigational product (IMP) <br/ ><br>2.Safety: <br/ ><br>a.Solicited ARS, Unsolicited AEs and SAEs throughout the entire study period. <br/ ><br>b.Medically attended adverse events (MAAEs) or AEs leading to withdrawal through the entire study period. <br/ ><br>Timepoint: Starting 14 days after the last IMP dose→ | | | | Yes | False | | |
| → | CTRI/2021/05/033835 | 7 September 2021 | Low dose Radiation (LDRT) to Lungs to treat COVID- 19 patients | Role of one time Low dose Radiation (LDRT) to whole Lung in the
Treatment of COVID 19 Disease. - LDRT AS AN ADJUNCTIVE IN COVID-19 | | ViswaBharathi Medical College and General Hospital | 27-05-2021 | 20210527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56339 | Not Recruiting | No | | | | 08-06-2021 | 218 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 2 | India→ | Dr S Muneeruddin Ahmed→ | | Viswabharathi medical college and General Hospital Penchikalapadu Kurnool Andhra Pradesh Office of the Principal
Viswabharathi Medical College
R T Nagar Penchikalapadu Kurnool AP→ | vmcknl@gmail.com→ | 09848076186→ | Viswabharathi medical college→ | Inclusion criteria: Adult patients with RT-PCR proven COVID 19 disease with moderate to severe pneumonia with fewer than 14 days of symptom onset on standard medications for Covid-19 which included anti-viral drugs, steroids, anticoagulant drugs, and other supportive therapy drugs according to the ICMR and WHO guidelines. <br/ ><br> <br/ ><br>Moderate to severe dyspnoea, Respiratory rate equal to or >24/min, Oxygen saturation 93% or less, PaO2/FiO2 ratio between 100-200. <br/ ><br> <br/ ><br>CRP >100mg/l or D-Dimer >1000ng/ml or suspected cytokine release syndrome. <br/ ><br> <br/ ><br>Criteria 1 and 2 are mandatory; 3 are optional. <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1. Patients on ventilators (invasive/non invasive). <br/ ><br>2. Patients with previous lobectomy or Pneumonectomy. <br/ ><br>3. Patients who have undergone previous Radio Therapy. <br/ ><br>4. Patients who have undergone previous chemotherapy; drug installation (gemci/bleomycin) or radio sensitization within 14days or 5 half lives. <br/ ><br>5. Patients with prior cancer immunotherapy within 60 days of enrolment. <br/ ><br>6. Patients with Severe pre existing heart disease- NYHA Class 3/ >; CHF. <br/ ><br>7. Patients with History of bone marrow or solid organ transplant. <br/ ><br>8. Patients with Known history of autoimmune collagen vascular disease (e.g. scleroderma) <br/ ><br>9. Patients with Known hereditary syndrome with increased sensitivity to ionizing radiation .e.g. ataxia telangectasia or fanconi anaemia. <br/ ><br>10. Patients with pregnancy <br/ ><br>11. Patients with Inability to lie in supine posture for radiation treatment. <br/ ><br>12. Patients with Inability to provide informed consent or lack of an authorized representative who can provide informed consent. <br/ ><br>→ | Health Condition 1: B342- Coronavirus infection, unspecified
Health Condition 2: J128- Other viral pneumonia
→ | Intervention1: Role of one time Low dose radiation(LDRT) to whole lung in the treatment of COVID19 disease.: Low dose radiation using a linear accelerator to bilateral whole lungs as a single fraction treatment with a dose of 0.5Gy in addition to other pharmacological treatment based on guidelines devised by ministry Of Health And Family Welfare,India-Dexamethasone 6mg IV once daily (Methyprednisolone 80mg IV BD),Remedesvir 200mg IV once daily on Day 1 followed by 100mg IV once daily for next 4days.Vitamin D 60,000u/Week,Vitamin c 1500mg/day,Zinc,Paracetamol,Anti tussives,Antibiotics,Oxygen supplementation,Adjunctive therapies:IV thiamine,IV Vitamin C, N acetyl cysteine,High dose statins.The pharmacological therapies are individualised on a case by case basis.<br>Intervention2: Low dose Radiation in addition to standard pharmacological therapy.: Low dose radiation using linear accelerator to bilateral whole lungs as a single fraction treatment with a dose of 0.5Gy in addition to Pharmacological therapy based on guidelines devised by Ministry of health and family welfare,India-Inj Methylprednisolone 0.5-1mg/kg in 2divided doses(or equivalent dose of dexa) for 5-10days; Prophylactic UFH or LMWH(enoxaparin 0.5mg/kg per day SC).<br>Remedesvir 200mg IV day 1 f/b 100mg IV OD for next 4days and Tocilizumab 4-6mg/kg (individualised based on disease severity).<br>Adjunctive therapies:Paracetamol,Anti tussives,Antibiotics,Oxygen supplementation.<br><br>Control Intervention1: Standard pharmacological treatment: Pharmacological therapy based on guidelines devised by Ministry of health and family welfare,India-Inj Methylprednisolone 0.5-1mg/kg in 2 divided doses(or equivalent dose of dexamethasone) for 5-10days; Prophylactic UFH or LMWH(enoxaparin 0.5mg/kg per day SC).<br>Remedesvir 200mg IV day 1 → | The primary end point will be to evaluate the efficacy of low dose pulmonary radiation as an adjunctive treatment in viral Pneumonitis of COVID 19 patients in terms of improvement in the PaO2-FiO2 at least by 20% measured 72 hrs after radiation treatment till 7 days.Timepoint: 6th hourly follow up to 72 hours followed by daily assessment for 7 days.→ | | | | Yes | False | | |
| → | CTRI/2021/05/033836 | 7 September 2021 | Safety and Efficacy of ATR-002 for Hospitalized Patients with COVID-19 | RESPIRE - A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19 - ATR-002-202 | | Atriva Therapeutics GmbH | 27-05-2021 | 20210527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55147 | Not Recruiting | No | | | | 10-06-2021 | 220 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 2 | Germany;India;Netherlands;South Africa;Spain→ | Dr Deepa Arora→ | | Unit 206 The Corporate Park Sector-18 Vashi Navi Mumbai→ | deepaarora@clinexel.com→ | 9820648395→ | Clinexel Life Sciences Private Limited→ | Inclusion criteria: Informed Consent <br/ ><br>1. Capable of giving signed informed consent as described in Section 10.1.3, which includes <br/ ><br>compliance with the requirements and restrictions listed in the informed consent form (ICF) <br/ ><br>and in this protocol. <br/ ><br>Age <br/ ><br>2. Study participant must be at least 18 years of age at the time of signing the ICF. <br/ ><br>Type of Participant and Disease Characteristics <br/ ><br>3.1 Study participants in India with a laboratory confirmed diagnosis of SARS-CoV-2 infection <br/ ><br>presenting as moderate COVID-19 requiring hospitalization for COVID-19 and for medical <br/ ><br>reasons (see Section 8 and CLINICAL MANAGEMENT PROTOCOL: COVID-19, <br/ ><br>Government of India, Version 5, 03.07.20). <br/ ><br>3.2 At least one of the following clinical features need to be present: <br/ ><br>Dyspnea <br/ ><br>Hypoxia <br/ ><br>Fever <br/ ><br>Cough <br/ ><br>AND <br/ ><br>3.3 SpO2 between 90% and 93% on room air <br/ ><br>AND <br/ ><br>3.4 Respiratory Rate more or equal to 24 and less than 30 breaths per minute <br/ ><br>Patients presenting to the hospital without a laboratory confirmed SARS-CoV-2 infection will be <br/ ><br>tested locally for SARS-CoV-2 during the screening period. <br/ ><br>For sites in the EU: A CE certified SARS-CoV-2 PCR test kit is required to confirm infection. <br/ ><br>For sites outside the EU: SARS-CoV-2 PCR test kits certified according to local regulations are <br/ ><br>required to confirm infection. <br/ ><br>Weight <br/ ><br>4. Body weight at least 50 kg and have a body mass index (BMI) â?¥ 18.0 kg/m2 and < 40.0 kg/m2. <br/ ><br>5. Male or female. <br/ ><br>Pregnancy and Contraception <br/ ><br>Contraceptive use by women and men should be consistent with local regulations regarding the <br/ ><br>methods of contraception for those participating in clinical studies. <br/ ><br>6. A female study participant is eligible to participate if she is not pregnant or breastfeeding, <br/ ><br>and one of the following conditions applies: <br/ ><br>a. She is not a WOCBP as defined in Section 10.3.1. <br/ ><br>b. Is a WOCBP and is using a contraceptive method that is highly effective, with a <br/ ><br>failure rate of <1%, as described in Section 10.3.2 during the IMP period and for at <br/ ><br>least 4 weeks after the last dose of IMP. The investigator should evaluate the <br/ ><br>potential for contraceptive method failure (e.g., noncompliance, recently initiated) in <br/ ><br>relationship to the first dose of IMP. <br/ ><br>7. A WOCBP must have a negative urine pregnancy test within 24 hours before the first dose of <br/ ><br>IMP, see Section 8.3.5. <br/ ><br>a. If a urine pregnancy test cannot be confirmed as negative (e.g., an ambiguous result), <br/ ><br>a serum pregnancy test is required locally. In such cases, the participant must not be <br/ ><br>randomized if the serum pregnancy result is positive. <br/ ><br>b. If a serum pregnancy test is required as per local regulations, a serum pregnancy test <br/ ><br>is required locally. In such cases, the participant must not be randomized if the serum <br/ ><br>pregnancy result is positive. <br/ ><br>c. The investigator is responsible for review of medical history, menstrual history, and <br/ ><br>recent sexual activity to decrease the risk for inclusion of a woman with an early <br/ ><br>undetectable pregnancy. <br/ ><br>8. A male study participant is eligible to participate if: <br/ ><br>a. He is azoospermic <br/ ><br>b. The partner is not a WOCBP as defined in Section 10.3.1. <br/ ><br>c. The partner is a WOCBP and is using a contraceptive method that is highly effective, <br/ ><br>wit→ | Exclusion criteria: 1. Patientâ??s clinical condition is worsening rapidly. <br/ ><br>2. Requiring ICU admission or ventilator support at screening or at randomization. <br/ ><br>Suspected bacterial, fungal, viral, or other infection (besides COVID-19). <br/ ><br>4. History of any of the following: malignant disease, autoimmune disease, or severe liver, <br/ ><br>kidney, blood, cardiac, pulmonary, neurological, or endocrine disease as judged by the <br/ ><br>investigator. The medical monitor should be contacted by the investigator. <br/ ><br>5.1 Patients with uncontrolled hypertension (BP â?¥ 140/90 mmHg). <br/ ><br>6. Clinically significant cardiac conduction abnormalities, including QTc prolongation of > <br/ ><br>450 milliseconds. <br/ ><br>7. Family history of Long QT Syndrome. <br/ ><br>8. Heart failure class 3, or 4, as defined by the New York Heart Association (NYHA). <br/ ><br>9.1 History of acute coronary syndrome (including myocardial infarction), coronary angioplasty, <br/ ><br>stenting, or thromboembolic event within 24 weeks prior to screening. <br/ ><br>10. Patients with implanted defibrillators or permanent pacemakers. <br/ ><br>11. Poorly controlled diabetes mellitus with an HbA1c > 7.5 %. <br/ ><br>12. Renal disease including glomerulonephritis, nephritic syndrome, Fanconi Syndrome, or <br/ ><br>renal tubular acidosis. <br/ ><br>13. Renal failure requiring renal replacement therapy or moderate renal impairment as defined <br/ ><br>by having an estimated glomerular filtration rate (eGFR, CKD-EPI) < 45 ml/min/1.73m2. <br/ ><br>14. Chronic Obstructive Pulmonary Disease (COPD) GOLD C, or D, or hospitalization for <br/ ><br>exacerbation of COPD within 24 weeks prior to screening. <br/ ><br>15. Other chronic lung diseases including cystic fibrosis, neuromuscular diseases, severe chest <br/ ><br>wall deformities, interstitial lung diseases, outpatient chronic non-invasive ventilation due to <br/ ><br>chronic respiratory failure. <br/ ><br>16. Asthma with a symptom control level of "uncontrolled", according to current GINA <br/ ><br>guidelines. <br/ ><br>17. Currently suffering from diseases that seriously affect the immune system, such as: human <br/ ><br>immunodeficiency virus (HIV) infection, or the blood system, or splenectomy, or organ/ <br/ ><br>stem cell transplantation. <br/ ><br>18. Known Hepatitis B or C infection. <br/ ><br>19. Any medical condition, physical examination finding or laboratory abnormality that, in the <br/ ><br>opinion of the investigator, might confound the results of the study or pose an additional risk <br/ ><br>to the patient. <br/ ><br>20. Alanine transaminase (ALT) or aspartate transaminase (AST) >3.0 x ULN. <br/ ><br>21. Total bilirubin >1.0 x ULN (â?¥1.5 x ULN total bilirubin if known Gilbertâ??s syndrome). <br/ ><br>Prior/Concomitant Therapy <br/ ><br>22. Taking concomitant medication metabolized by CYP2C8 and/ or CYP2C9 and listed as <br/ ><br>â??prohibitedâ?? in Section 10.5. <br/ ><br>23. Taking concomitant medication of any experimental treatment or use of marketed <br/ ><br>medications including off-label use, that are intended as specific treatment for COVID19. <br/ ><br>Any such treatments must be washed out for 30 days or at least 5 half-lives prior to <br/ ><br>randomization, whichever is longer, unless a formal written standard of care policy document requires otherwise. Inclusion needs to be approved by the investigator and <br/ ><br>medical monitor. <br/ ><br>Taking medication that may seriously affect the immune system, e.g., chemotherapy, unless <br/ ><br>considered and documented as standard of care (e.g., corticosteroids→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ATR-002: 900 mg (6 tablets) once daily on Day 1<br>600 mg (4 tablets) once daily on Days 2 to 6<br>Intervention2: Placebo: 6 matching placebo tablets<br>on Day 1<br>4 matching placebo tablets<br>on Days 2 to 6<br>Control Intervention1: Matching Placebo: 6 tablets once daily on Day 1 and 4 tablets once daily on Days 2 to 6<br>→ | Clinical severity status on a 7 point ordinal scale at Day 15 <br/ ><br>Time from randomization to discharge from hospital <br/ ><br>Time to discharge from hospital or to score of â?¤2 maintained for 24 hours in NEWS2 whichever occurs first <br/ ><br>Time to resolution of fever defined as â?¤36.6°C (axilla) â?¤37.2°C (oral) or â?¤37.8°C (rectal or tympanic) for at least 24 hours without antipyretics for 24 hours. <br/ ><br>Time to SpO2 94% on room air maintained for 24 hours <br/ ><br>Timepoint: Day 15→ | | | | Yes | False | | |
| → | CTRI/2021/05/033837 | 7 September 2021 | A study on association of multiple intrinsic and extrinsic factors and severity of COVID -19 Disease | Investigating the putative association between multiple intrinsic and extrinsic factors associated with the host and the severity of COVID-19 disease presentation in Yenepoya Medical College, Mangalore, Karnataka, India | | Yenepoya Deemed to be University | 27-05-2021 | 20210527 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56150 | Not Recruiting | No | | | | 02-08-2021 | 4000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ranajit Das→ | | Yenepoya Research Centre,
3rd Floor, Academic block
Yenepoya Deemed to be University
Deralakatte → | das.ranajit@gmail.com→ | 08582802871→ | Yenepoya (Deemed to be University)→ | Inclusion criteria: Patients with a confirmed diagnosis of COVID-19→ | Exclusion criteria: NA→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | association between extrinsic factors and the severity of COVID 19Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/05/033845 | 7 September 2021 | Fifth population based covid19 Antibody study in Ahmedabad. | Fifth population based serosurveillance for SARS-CoV2 using IgG antibodies in Ahmedabad - AB5 | | Ahmedabad Municipal Corporation | 28-05-2021 | 20210528 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55938 | Not Recruiting | No | | | | 29-05-2021 | 4500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Om Prakash→ | | Office of Deputy Municipal Commissioner (Health), 2nd Floor, Sardar Patel Bhavan, Danapith, Ahmedabad → | dromprakash2006@gmail.com→ | 9099012740→ | Ahmedabad Municipal Corporation→ | Inclusion criteria: Those who give informed written consent→ | Exclusion criteria: any bleeding disorder, contraindication to venipuncture & hospitalized patients→ | | | Seroprevalence of IgG Antibodies against SARS-CoV-2 in general population of AhmedabadTimepoint: 1. Since this is a cross sectional study, there is only one time point→ | | | | Yes | False | | |
| → | CTRI/2021/05/033846 | 7 September 2021 | An Open Label, Multicentre, Multi-Dose, Single Arm Treatment Clinical Trial in Human Adult, Patients With Mild COVID-19. | An open label, multicentre, multi-dose, single arm treatment clinical trial to determine the safety and efficacy of earth tea manufactured by martin Sinclair b4b corp, 40 remsen ave, Brooklyn, NY 11212, United states in human adult, patients with mild COVID-19. - EART-001-21 | | Martin Sinclair BB Corp | 28-05-2021 | 20210528 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56398 | Not Recruiting | No | | | | 04-06-2021 | 15 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Reenee Rajan→ | | Door No.6, Kamarajar Salai,
Clinical department, Room No.1, Ground Floor Selaiyur, East Tambaram→ | reenee@microtheraps.com→ | 919940502533→ | KMS Hospital→ | Inclusion criteria: 1. Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures. <br/ ><br>2. Age 18-75 years (both inclusive) at the time of signing ICF. <br/ ><br>3. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization). <br/ ><br>4. Patients with uncomplicated respiratory tract viral infection <br/ ><br>5. For female patients: evidence of post-menopause or for Pre-menopause patients, negative pretreatment serum or urine pregnancy test. <br/ ><br>6. Eligible patients of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment. <br/ ><br>7. Not participating in any other interventional drug clinical studies before completion of the present study <br/ ><br>8. Controlled diabetic patients with HbA1C limit < 7.0 <br/ ><br>9. Hypertension Patients up till Hypertension Stage 2 shall be included in the study (Systolic blood pressure at least 140mm Hg and Diastolic blood pressure at least 90 mm Hg) <br/ ><br>10. Time interval between symptoms onset and randomization to no more than 7 days. <br/ ><br>11. Pyrexia (axillary > 98.6°F or frontal >99.5°F); or/and any of the following symptoms: <br/ ><br>â?¢ Cough <br/ ><br>â?¢ Sore throat <br/ ><br>â?¢ Headache <br/ ><br>â?¢ Nasal congestion <br/ ><br>â?¢ Body aches and pains <br/ ><br>â?¢ Fatigue <br/ ><br>12. Patients with Loss of smell and Taste. <br/ ><br>→ | Exclusion criteria: COVID - 19 patients with history or significant presence of the following will be excluded from participation/enrollment in the study trial: <br/ ><br>1. Severe infection, defined as oxygen saturation (SPO2) â?¤93 % or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) â?¤300 mmH or need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ ><br>2. Requires ICU care for management of ongoing clinical status. <br/ ><br>3. Participation in this study will not be in the best interest of the patient, or any other circumstances that prevent the patient from participating in the study safely. <br/ ><br>4. Inability to intake or tolerate oral medications like refractory nausea, vomiting, or gastrointestinal disorders, or having undergone extensive bowel resection which may affect adequate absorption of the drug. <br/ ><br>5. Known severe renal impairment [creatinine clearance (CrCl) <30 mL/min] or having received continuous renal replacement therapy, hemodialysis or peritoneal dialysis; CrCl is to be calculated by the following Cockcroft-Gault formula only when the serum creatinine is >1.5Ã?ULN. <br/ ><br>6. patient has a serious chronic disease (e.g., human immunodeficiency virus (HIV), cancer requiring chemotherapy within the preceding 6 months, unstable cardiac, pulmonary (Asthma, chronic obstructive lung disease), neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days. <br/ ><br>7. Psychiatric disease that is not well controlled (controlled defined as stable on a regimen for more than one year). <br/ ><br>8. Known severely reduced LV function (Ejection fraction <30%) <br/ ><br>9. Severe liver disease: underlying liver cirrhosis or Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 5 times the ULN. <br/ ><br>10. Gout/history of gout or hyperuricemia (above the ULN). <br/ ><br>11. Pregnant or lactating women. <br/ ><br>12. Having participated in any other interventional drug clinical study within 30 days prior to first dose of study drug. <br/ ><br>13. Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of admission. <br/ ><br>14. Patients with diabetes having HbA1C limit > 7.0 <br/ ><br>15. Patients with Hypertensive crisis. <br/ ><br>→ | | | Proportion of patients with Microbiological cure at Day 02. <br/ ><br>Timepoint: Study enrolment visit (Day 00) <br/ ><br>On Therapy visit (Day 01) <br/ ><br>Evaluation visit (Day 02) <br/ ><br>→ | | 14/07/2021 | | Yes | False | | |
| → | CTRI/2021/05/033856 | 7 September 2021 | To study the employee engagement activities adopted by the organisation during the covid 19 pandemic | Employee engagement during covid 19 | | Shradha Radhakrishnan | 28-05-2021 | 20210528 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56181 | Not Recruiting | No | | | | 28-05-2021 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shradha Radhakrishnan→ | | Thayamba house
Kavumbagam
Ummenchira(po)
Telicherry
Kannur → | somu.g@manipal.edu→ | 9448463186→ | Manipal Academy Of Higher Education→ | Inclusion criteria: Non teaching staffs→ | Exclusion criteria: Others excluded other than non teaching staff→ | | | Employee engagement level during covid 19Timepoint: 3months→ | | | | Yes | False | | |
| → | CTRI/2021/05/033857 | 7 September 2021 | Antibody response after Covid-19 vaccine alongwith Kabasura Kudineer | A prospective, double blind, randomized clinical study to evaluate the antibody response after Covid-19 vaccine when provided along with Kabasura Kudineer, a siddha medicine | | Sri Sri Institute of Advance Research | 28-05-2021 | 20210528 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56037 | Recruiting | No | | | | 01-06-2021 | 500 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | N/A | India→ | ANJU DHAWAN→ | | DEPARTMENT OF PSYCHIATRY AND NDDTC, ALL INDIA INSTITUTE OF MEDICAL SCIENCES → | DRANJUDHAWAN@GMAIL.COM→ | 9818329539→ | AIIMS→ | Inclusion criteria: Inclusion criteria <br/ ><br>-Persons without a history of SARS-CoV-2 infection <br/ ><br>-Participants yet to receive Covid-19 vaccine. <br/ ><br>-Residence within a 10-kilometre radius of AIIMS hospital <br/ ><br>→ | Exclusion criteria: -Patients with associated comorbidities like hypertension, type 2 or type 1 diabetes or chronic or acute renal failure or any major systemic illness <br/ ><br>-Patients on Immuno-suppression therapy <br/ ><br>-Pregnant Women or lactating mothers <br/ ><br>→ | | Intervention1: Kabasura Kudineer tablet: 2 tablets will be taken orally, twice a day- Morning and Night after food for 12 weeks <br>Initiated on the day of the first dose of the vaccine<br><br>→ | Change from baseline in antibodies count following 4 weeks after first dose of vaccine, 4 weeks after second dose of vaccine and at 6-8 weeks after 2nd dose.Timepoint: Baseline, 4 weeks after first dose of vaccine, 4 weeks after second dose of vaccine and 6-8 weeks after 2nd dose of vaccine.→ | | | | Yes | False | | |
| → | CTRI/2021/05/033864 | 7 September 2021 | Clinical Trial to Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Moderate Coronavirus Disease (COVID-19) | A Prospective, Randomized, Parallell, Multi-centric, Open label, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Moderate Coronavirus Disease (COVID-19) | | MSN Laboratories Private Limited | 28-05-2021 | 20210528 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56323 | Recruiting | No | | | | 07-06-2021 | 1282 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 3 | India→ | K Ravinder Reddy→ | | MSN Group of Companies,
MSN House, Plot No: C-24,
Industrial Estate, Sanathnagar,
Hyderabad
→ | antaryami@abiogenesisclinpharm.com→ | 7702186021→ | Abiogenesis Clinpharm PVT LTD→ | Inclusion criteria: 1.Male or female subjects of 18 years to 60 years age (both inclusive) <br/ ><br>2.Subject and/or his/her legally accepted representative willing to give written informed consent. <br/ ><br>3.Subjects with laboratory confirmation of infection with SARS-CoV-2 by positive RT-PCR (within 48 hours prior to randomization). <br/ ><br>4.Subjects having moderate COVID-19 as per MoH & FW guidelines on â??Clinical Management Protocol: COVID-19â?? as updated from time to time. <br/ ><br>o Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 â?¤93% (range 90-93%) on room air, respiratory rate more or equal to 24 per minute. (Time for symptom onset and baseline should be no more than 10 days). <br/ ><br>→ | Exclusion criteria: 1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient. <br/ ><br>2.Subjects with severe COVID-19: severe pneumonia. with clinical signs of pneumonia plus one of the following; respiratory rate >30 breaths/min, severe respiratory distress, SpO2 <90%. <br/ ><br>3.Subjects with history of chronic liver disease (Child Pugh class B or C), severe liver disease like underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 3 times the ULN and chronic renal disease (creatinine clearance (CrCl) <30ml/min). <br/ ><br>4.Subjects with oxygen saturation (SPO2) below 90% or arterial oxygen partial pressure (PaO2)/ fraction of inspired O2 (FiO2) â?¤300 mmHg. <br/ ><br>5.Refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug or having undergone extensive bowel resection which may affect adequate absorption of Molnupiravir. <br/ ><br>6.Pregnant or breast-feeding subjects will be excluded. <br/ ><br>7.Subject currently using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ ><br>8.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening. <br/ ><br>9.Subject has history of any serious chronic disease (e.g., human immunodeficiency virus (HIV); cancer requiring chemotherapy within the preceding 6 months; unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days. <br/ ><br>10.Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ ><br>11.Subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. <br/ ><br>12.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ ><br>13.Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ ><br>14.Participated in any other clinical trial or taken investigational drug within 1 month. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Molnupiravir and Standard of Care: Molnupiravir 800 mg (4 capsules of 200 mg) administered orally every 12 hours for 5 days AND Standard of Care<br>Control Intervention1: Standard of Care: Standard of care as per the Clinical Guidance for Management of Adult COVID-19 by ICMR<br>→ | Proportion of patients with clinical improvement at Day fourteen <br/ ><br>Timepoint: Proportion of patients with clinical improvement at Day fourteen <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/05/033867 | 7 September 2021 | Oral Doxycycline for COVID-19 patients | A randomised controlled trial to assess the ability of doxycycline to reduce the need for ICU admission in patients with proven COVID-19 infection (DOXPREVENT.ICU)
- DOXPREVENT.ICU | | You Breathe We Care | 31-05-2021 | 20210531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48841 | Not Recruiting | No | | | | 31-05-2021 | 250 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | N/A | India→ | Dr Raja Dhar→ | | Department of Pulmonology,
Level-1, Speciality clinics
CK Birla Hospitals
The Calcutta Medical Research Institute
7/2 Diamond Harbour Road,Kolkata P-171/1 CIT Scheme VII-M
Kolkata-700054→ | pulmoresearch@gmail.com→ | | YOU BREATHE WE CARE→ | Inclusion criteria: Able to give informed consent â?¢ Male or female, age 40to 90 years â?¢ Typical symptoms of COVUD-19 infection: new onset of or exacerbation of cough due to chronic respiratory illness, dyspnea, Increased body temperature (forehead T° >37.6°C; oral T° >38°C; axillary >37.5°C) â?¢ SARS-CoV-2 infection demonstrated by PCR â?¢ Admission to hospital within 10 days of onset of symptoms→ | Exclusion criteria: Hypersensitivity to doxycycline; myasthenia gravis; pregnancy; hepatic failure (CHILD-Pugh score C); unable to give informed consent→ | Health Condition 1: B342- Coronavirus infection, unspecified
Health Condition 2: B342- Coronavirus infection, unspecified
Health Condition 3: B338- Other specified viral diseases
→ | Intervention1: Doxycycline: Intention to treat with 200 mg oral doxycycline tablet qd for fourteen days on top of the standard of care (SOC).<br>Control Intervention1: Usual care: Standard care of COVID-19 as per local guidelines<br>→ | Admission to ICUTimepoint: Day zero to Day 14→ | | | | Yes | False | | |
| → | CTRI/2021/05/033868 | 7 September 2021 | Radiotherapy to lungs for COVID-19 pneumonia | Low dose radiotherapy to bilateral lungs for COVID-19 pneumonia - A Prospective Single Centre Study | | Kolhapur Cancer Centre | 31-05-2021 | 20210531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56406 | Not Recruiting | No | | | | 05-06-2021 | 50 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Reshma Pawar→ | | Kolhapur Cancer Centre
R.S. No. 238, Opposite Mayur Petrol Pump, Gokul Shirgaon, Near Shahu Naka, Kolhapur, Maharashtra, India → | prasad0297@gmail.com→ | 9167975011→ | Kolhapur Cancer Centre→ | Inclusion criteria: Patients with RT-PCR proven COVID-19 infection with moderate to severe pneumonia with National Early Warning Score [NEWS] 5 or more.→ | Exclusion criteria: 1.Patients requiring mechanical ventilation <br/ ><br>2.Prior lobectomy or pneumonectomy <br/ ><br>3.Prior thoracic radiotherapy <br/ ><br>4.Prior chemotherapy or other systemic therapy with potential for pulmonary toxicity <br/ ><br>5.Prior radio-sensatization <br/ ><br>6.Severe pre-existing heart disease e.g. New York Heart Association [NYHA] functional class 3 or higher, congestive cardiac failure <br/ ><br>7.History of Bone marrow or solid organ transplant <br/ ><br>8.Known history of autoimmune collagen vascular disease <br/ ><br>9.Known hereditory syndrome with increased sensitivity to ionizing radiation e.g. ataxia-telengiectasia or Fanconi anemia <br/ ><br>10.Pregnancy <br/ ><br>11.Inability to lie down supine and flat for radiotherapy <br/ ><br>12.Inability to provide informed consent or lack of authorized representative who can provide informed consent.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Low dose radiotherapy to bilateral lungs for COVID-19 pneumonia - A Prospective Single Centre Study: Low dose radiotherapy using linear accelerator to bilateral whole lungs to a dose of 70cGy in single fraction in addition to standard pharmacological therapy based on the guidelines devised by Ministry of Health and Family Welfare, India.<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | To evaluate the clinical response of low dose radiotherapy to bilateral lungs in patients with COVID-19 pneumonia.Timepoint: Day 0,1,2,3,5,8,15 and 28→ | | | | Yes | False | | |
| → | CTRI/2021/05/033869 | 7 September 2021 | Can the benefit of prone position benefit in reducing oxygen requirements in oxygen dependent COVID-19 patients | Can awake prone positioning strategies spark a revolution in management of oxygen dependent Covid-19 patients | | Sapthagiri institute of medical sciences and research centre | 31-05-2021 | 20210531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55290 | Recruiting | No | | | | 09-06-2021 | 40 | Interventional | Other<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | Renuka R→ | | Department of Anaesthesiology SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
15 Chikkasandra Hesaraghatta main road Bangalore Department of Anaesthesiology SAPTHAGIRI INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE
15 Chikkasandra Hesara→ | drmadhumitha9@rediffmail.com→ | 8105196837→ | sapthagiri institute of medical sciences and research centre→ | Inclusion criteria: 1)Onset within 1 week of covid 19 <br/ ><br>2)new onset or worsening respiratory symptoms <br/ ><br>3)hypoxia ( Spo2 < 94% on RA ) <br/ ><br>4)Diagnosed covid with RTPCR nasal / nasopharyngeal / oropharyngeal swab <br/ ><br>→ | Exclusion criteria: Chronic kidney disease <br/ ><br>Malignancy <br/ ><br>Diabetes <br/ ><br>cvs , respiratory and liver diseases <br/ ><br>Obesity <br/ ><br>Uncooperative / drowsy patients <br/ ><br>Ophthalmic diseases â?? glaucoma <br/ ><br>Cervical spondylosis / unstable spine <br/ ><br>Abdominal pathologies including pregnancy <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: awake prone positioning: awake prone positioning method employed in oxygen dependent COVID-19 patients for a maximum of 3 hrs in the morning and 3 hrs maximum in the evening , if the patient is not comfortable for aduration of 3 hrs then as much time as possible and comfortable to the patient will be suggested and recorded accordingly<br>Control Intervention1: not applicable: not applicable as it is a single arm trial, those patients who are not willing for prone positioning will be considered in this .Hence , they are not subjected to any intervention or positioning<br>→ | Duration of weaning from oxygen support <br/ ><br>Timepoint: patient will be asessed at the point of entry to trial as baseline , every 24 hrs , till recovery / intubation→ | | | | Yes | False | | |
| → | CTRI/2021/05/033870 | 7 September 2021 | Qualitative Study of Health-seeking and Healthcare Availability in COVID patients | Factors influencing health-seeking behavior of and healthcare availability to COVID-19 patients in a tertiary care hospital: A Qualitative Study | | Yuvaraj B Chavan | 31-05-2021 | 20210531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56347 | Not Recruiting | No | | | | 30-06-2021 | 6 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Yuvaraj B Chavan→ | | Community Medicine Dept.
3rd Floor, Library Building,
KEM Hospital,
Parel, Mumbai → | yuvarajbc@yahoo.co.in→ | | KEM Hospital→ | Inclusion criteria: 1.Patients admitted to the COVID-19 ward of our tertiary care hospital for the treatment of COVID-19. <br/ ><br>2.Patients who are conscious, co-operative, and oriented to time, place, and person and capable of engaging in the in-depth interview.→ | Exclusion criteria: 1.Patients who are not mentally stable. <br/ ><br>2.Patients not willing to participate.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | This study will help identify the potential factors influencing health-seeking behavior and outcomes of COVID-19 patients and pinpoint any possible weak links in ensuring good health-seeking behavior, treatment, and outcome of COVID patients, in order to generate research questions for future studies and identify future measures to improve upon these domains. <br/ ><br>Due to the qualitative nature of the study, no definite outcome measures.Timepoint: The single time point at which the qualitative data will be analysed will be 4 weeks from the start of the study.→ | | | | Yes | False | | |
| → | CTRI/2021/05/033871 | 7 September 2021 | Oral blood thinners versus injectable blood thinners in preventing clotting disorders associated with COVID 19 infection | Oral versus Parenteral anticoagulation in the prophylaxis and therapeutic management of thromboembolic disease in hospitalised patients with confirmed COVID-19 disease | | Dhiraj Kumar | 31-05-2021 | 20210531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55087 | Not Recruiting | No | | | | 01-08-2021 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Alternation Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Kaimaparambil→ | | SevenHills Dedicated COVID Hospital → | vaishnavikm94@gmail.com→ | 09892075408→ | SevenHills Dedicated COVID Hospital→ | Inclusion criteria: 1. Participants were enrolled after RT PCR-evidence of COVID-19 infection or radiological evidence of COVID-19 associated mild or moderate infection requiring hospitalisation. <br/ ><br>2. Ages 25 to 75 years. <br/ ><br>3. If mild infection (uncomplicated URTI without evidence of breathlessness or hypoxia [SpO2 >94% as defined by local guidelines), to be included if CHADSVASc2 score is â?¥2 if female, â?¥1 if male; D-dimer levels >500 ng/mL or have previous history of malignancy, deep vein thrombosis (DVT), systemic embolism or ischaemic events. <br/ ><br>4. All patients with moderate infection (features of pneumonia with dyspnoea, hypoxia [SpO2 90-94%], respiratory rate >23/minute as defined by local guidelines) to be included regardless of CHADSVASC score and D-D-dimer levels. <br/ ><br>5. Documented informed consent→ | Exclusion criteria: Exclusion criteria: <br/ ><br> Severe disease (pneumonia with SpO2 <90% or respiratory rate >30/minute or severe respiratory distress) or critical illness (signs of shock, sepsis, multi-organ failure. <br/ ><br>Chronic liver disease ((e.g., acute hepatitis, chronic active hepatitis, cirrhosis) or ALAT > 3 x ULN. <br/ ><br>Chronic kidney disease (eGFR <30 mL/min/1.73m2). <br/ ><br>History of intracranial bleeding in the last 3 months. <br/ ><br>Bleeding diathesis, active peptic ulcer disease. <br/ ><br>Pregnancy or first postpartum week. <br/ ><br>Refractory hypertension (SBP >180 mmHg). <br/ ><br>Any other contraindication listed in the local labelling of enoxaparin and rivaroxaban→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Rivaroxaban: 10mg or 15mg per oral, once daily; duration of hospital stay or 15days, whichever is longer<br>Control Intervention1: Enoxaparin: 40mg or 60mg subcutaneous, once daily; duration of hospital stay or 15days, whichever is longer<br>→ | Composite of all major haemorrhagic and thrombotic eventsTimepoint: Duration of hospital stay; time to event→ | | 01/06/2021 | | Yes | False | | |
| → | CTRI/2021/05/033873 | 7 September 2021 | Pre-emptive steroids to alter the disease course in COVID-19 patients | AN OPEN-LABEL, ADAPTIVE, RANDOMISED COMPARATIVE TRIAL OF PRE-EMPTIVE GLUCOCORTICOIDS VERSUS STANDARD OF CARE PROTOCOL FOR HOME ISOLATED MILD CATEGORY COVID-19 PATIENTS: PRESTECOV TRIALâ??. - PRESTECOV | | JK Hospital and LN Medical College | 31-05-2021 | 20210531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55708 | Not Recruiting | No | | | | 02-05-2022 | 500 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:Alternation Blinding and masking:Open Label | N/A | India→ | Prakhar Gupta→ | | Department of Medicine, third floor
JK Hospital and LN Medical college → | itsme.prakhar@gmail.com→ | | JK Hospital and LN Medical College→ | Inclusion criteria: 1.Male or non-pregnant female adult â?¥â??18â??years of age at the time of enrolment <br/ ><br> <br/ ><br>2.Confirmed diagnosis of SARS-CoV-2 infection, defined as either: <br/ ><br> <br/ ><br>a. <br/ ><br>SARS-CoV-2 PCR positive within 72â??h before randomization <br/ ><br> <br/ ><br>or <br/ ><br> <br/ ><br>b. <br/ ><br>In patients without PCR-confirmed diagnosis at inclusion, all efforts will be made to confirm definite SARS-CoV-2 infection (e.g., PCR on bronchial aspirate, PCR on BAL fluid or serologic testing). Participants whoâ??despite all effortsâ??do not have a confirmed diagnosis of COVID-19 will be excluded from the analysis. <br/ ><br> <br/ ><br>3. Patients eligible for home isolation.→ | Exclusion criteria: 1. Moderate to Severe type of disease, with at least one of the following criteria: <br/ ><br>o Frequency of breath > 24 per minute, which does not decrease after the body temperature drops to normal or subfebrile values; <br/ ><br>o Blood oxygen saturation (SpO2) < 94% at rest; <br/ ><br>o Chest involvement on HRCT <br/ ><br>o Partial pressure of oxygen in arterial blood (PaO2) < 60 mm Hg; <br/ ><br>o Oxygenation index (RaO2/FiO2) â?¤ 200 mm Hg; <br/ ><br>o Partial pressure of CO2 in arterial blood (PaCO2) < 60 mm Hg; <br/ ><br>o Septic shock. <br/ ><br>2. Patients treated with lopinavir/ritonavir, ribavirin, arbidol, chloroquine, hydroxychloroquine, mefloquine, favipiravir within 7 days prior to screening. <br/ ><br>3. Severe cardiovascular diseases currently or 6 months prior to trial. <br/ ><br>uncontrolled arterial hypertension with systolic blood pressure > 180 mm Hg and diastolic blood pressure > 110 mm Hg, pulmonary embolism or deep vein thrombosis. <br/ ><br>4. Severe chronic renal impairment (GFR < 30 ml / min) or continuous renal replacement therapy, hemodialysis or peritoneal dialysis. <br/ ><br>5. A history of cirrhosis or an increase in alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST) > 5 times Ã? upper limit of normal (ULN). <br/ ><br>7. Significant uncontrolled concomitant disease, e.g. neurological, renal, hepatic, endocrinological or gastrointestinal disorder which according to the Investigator, could prevent the patient from participating in the study <br/ ><br>8. Malignancies that require chemotherapy within 6 months prior to screening. <br/ ><br>9. Known HIV infection. <br/ ><br>10. Uncontrolled Diabetes Mellitus. <br/ ><br>11. Participation in other clinical studies or taking other study drugs within 28 days prior to screening. <br/ ><br>12. Pregnant or lactating women. <br/ ><br>13. Patients not giving consent.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Methylprednesolone cohort: Systemic steroids given pre-emptively at Day 5 in addition to the standard care:<br>Methylprednisolone administered for 14 Days: 2 phases- prevention phase for 1 week followed by maintenance and tapering phase for 1 week<br><br>Category 1:4- 8 mg Per Day If Minimal Initial Symptoms<br>(Fever 100.5f, Bodyache, Headache, Sore Throat, HRCT 5%) Upgrade to Cat 2 If Symptoms Persist Beyond 3 Days or Increasing<br><br>Category 2: 12-32 mg Per Day If Moderate Symptoms<br>(Fever 100.5F â?? 103F, Loss of Smell/ Taste, Lethargy, Cough)<br><br>Control Intervention1: Standard of care cohort: Protocol for mild cases of COVID-19 patients as delineated by AIIMS/ ICMR-COVID-19 National Task Force/Joint<br>Monitoring Group.<br>→ | Number of patients requiring hospitalisation, supplemental oxygen and/or ICU care as compared to Standard of care protocol. <br/ ><br> <br/ ><br>Timepoint: Baseline, 7 days, 14 days and if applicable-ICU Status/ hospitalisation time→ | | | | Yes | False | | |
| → | CTRI/2021/05/033883 | 7 September 2021 | Low dose Radiotherapy for COVID-19 using Linear accelerator | Bilateral Whole lung Irradiation as a Novel treatment for COVID-19 induced acute respiratory distress syndrome(ARDS) | | Surya Global Multi Speciality Hospital | 31-05-2021 | 20210531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56315 | Not Recruiting | No | | | | 03-06-2021 | 50 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Sk khadari→ | | Surya Global Multi Speciality Hospital
Madhavapatnam, Kakinada, Andhra Pradesh Surya Global Multi Speciality Hospital
Administrative Department
Third floor,Room No 4000
Madhavapatnam, Kakinada, Andhra Pradesh
533005→ | drsuryaveerraju@gmail.com→ | 9848124080→ | Surya Global Multi Speciality Hospital→ | Inclusion criteria: 1. Adult patients with RT-PCR proven COVID-19 with moderate to severe pneumonia with fewer than 14 days of symptom onset that <br/ ><br>warranted hospitalization and currently receiving standard medication for COVID-19 at appropriate doses which would include,among others, antivirals, corticosteroids, or anti-IL-6 tocilizumab.and <br/ ><br>2. moderate to severe dyspnoea, respiratory frequency equal to or greater than 30/min, oxygen saturation without supplemental O2 <br/ ><br>supply SpO2 94% or less, PaO2/FiO2 ratio or PaFiO2 ratio between 200 to 300 or SpO2/FiO2 ratio 315 or less if PaO2 is not available <br/ ><br>and/or <br/ ><br>3. laboratory abnormalities such as C-reactive protein >100 mg/L or D-dimer >1000 ng/ml or IL-6 >50 IU or suspected cytokine release <br/ ><br>syndrome→ | Exclusion criteria: 1. Patients on ventilators (invasive/non invasive) <br/ ><br>2. Prior lobectomy or pneumonectomy <br/ ><br>3. Prior thoracic radiotherapy resulting in a maximum lung dose of 100 cGy or higher within 14 days of enrollment <br/ ><br>4. Prior chemotherapy or other systemic therapy with potential for pulmonary toxicity or radio sensitization within 14 days or 5 half-lives, <br/ ><br>whichever is greater, of enrollment, e.g., bleomycin, gemcitabine <br/ ><br>5. Prior cancer immunotherapy with an immune checkpoint inhibitor within 60 days of enrollment <br/ ><br>6. Severe pre-existing heart disease, e.g., New York Heart Association (NYHA) functional class 3 (or higher) congestive heart failure <br/ ><br>7. History of bone marrow or solid organ transplantation <br/ ><br>8. Known history of autoimmune collagen vascular disease, e.g.,scleroderma <br/ ><br>9. Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia <br/ ><br>10. Pregnancy <br/ ><br>11. Inability to be positioned supine and flat for radiation planning and delivery <br/ ><br>12. Inability to provide informed consent or lack of an authorized representative who can provide informed consent→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Low Dose External Beam Radiation therapy in<br>addition to standard<br>pharmacological therapy: Low dose radiotherapy using a Linear accelerator to bilateral whole lungs as a single fraction treatment with a dose of 0.5 Gy<br>in addition to pharmacological therapy based on guidelines<br>devised by Ministry of Health and Family welfare, India<br>Dexamethasone 6mg IV Once<br>daily for 10 days (Alternative:<br>Methylprednisolone 80mg IV BD<br>for 10 days) Enoxiparin 60mgs/c Once Daily for 5 days (dose adjusted based on D-dimer levels), Remdesvir 200mg IV Once daily on day 1 followed by 100mg IV Once daily for next 4 days, further continuance based<br>on clinical response,<br>Convalescent plasma One or<br>two units (approximately<br>200-250ml per unit),<br>Tocilizumab 400mg IV as a<br>single dose (repeat dose in 12 to 24 hours if patientâ??s<br>condition has not improved),<br>Vitamin D 60,000U /week,<br>Vitamin C 1500 mg/day, Zinc,<br>Paracetamol, Anti-tussives,<br>Antibiotics, Oxygen<br>supplementation. Adjunctive<br>therapies : IV thiamine,IV<br>vitamin C, N acetyl cysteine Ulinastatin, Sepsivac<br>(mycobacterium w), high dose<br>statins. Salvage therapies :<br>Pulse therapy of steroids,<br>Cytosorb-hemoperfusion,<br>Pirfenidone,Alteplase. The<br>pharmacologic therapy is<br>individualized on a case by case basis<br>Control Intervention1: not applicable: not applicable<br>→ | The primary end-point will be to evaluate the efficacy of low-dose pulmonary irradiation as an adjunctive treatment in interstitial pneumonia in <br/ ><br>patients with COVID-19 by improving the Spo2 levels 48-72h after treatment with respect to baseline pre-irradiation measurementTimepoint: 6 hours,day 1,2,3,4,7→ | | | | Yes | False | | |
| → | CTRI/2021/05/033899 | 7 September 2021 | Evaluation of Adjuvant Effect of Ayurvedic Medicine in Oxygen Dependant COVID 19 Patients | Evaluation of Adjuvant Effect of Ayurvedic Herbo-mineral Medicine in Oxygen Dependant COVID 19 Pneumonia Patients - A Double Blind Placebo Controlled Study. | | Parul Institute of Ayurved | 31-05-2021 | 20210531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56230 | Not Recruiting | No | | | | 08-06-2021 | 48 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 2/ Phase 3 | India→ | Dr Harish Daga→ | | OPD No. 106, Parul Ayurved Hospital, Parul University, P.O. Limda, Tal. Waghodia,
Vadodara → | dr.shaileshd@gmail.com→ | 9763104451→ | Parul Institute of Ayurveda→ | Inclusion criteria: 1.Confirmed cases of COVID 19 pneumonia who require oxygen support. <br/ ><br>2.Subjects willing to sign informed consent.→ | Exclusion criteria: 1. Subjects who are known cases of immune-compromised or autoimmune condition such as HIV. <br/ ><br>2. Pregnant and lactating women. <br/ ><br>3. Patients needing intensive care or ventilator support. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ayurvedic Herbo-mineral capsule with standard modern treatment: Sahasra Puti Abhraka Bhasma 22 mg, Hrudayarnava Rasa 42 mg, Swarna Vasanta Malati 42 mg and Trikatu Churna 396 mg orally thrice daily after food with water for seven days<br>Control Intervention1: Cap placebo with standard modern treatment: Roasted wheat powder 500 mg orally thrice daily after food with water for seven days<br>→ | effect of Ayurvedic herbo-mineral combination on SpO2 levels in oxygen dependent COVID 19 pneumonia patients in comparison with placebo.Timepoint: From baseline till the end of seven days→ | | | | Yes | False | | |
| → | CTRI/2021/05/033900 | 7 September 2021 | Knowledge Perception and willingness towards covid vaccination amongst health care student population in a south indian town | Knowledge Attitude and Practices towards Covid vaccination amongst health sciences students in a south indian town | | Raahat Kapur | 31-05-2021 | 20210531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56267 | Not Recruiting | No | | | | 08-06-2021 | 480 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India→ | Raahat Kapur→ | | Community Medicine department,
Kasturba Medical College
Manipal Academy of Higher education
Manipal → | eshwari.k@manipal.edu→ | | Kasturba Medical college, Manipal Academy of Higher education, Manipal, 576104→ | Inclusion criteria: Any health science student who is in Kasturba Medical College or Manipal College of Dental Sciences who is willing to take part in this questionnaire can take part in this study→ | Exclusion criteria: Students from non-health sciences institutes of Manipal Academy of Higher Education.→ | | | To understand the knowledge of health sciences students towards Covid 19 vaccination within a south Indian townTimepoint: June 2021 to December 2021→ | | | | Yes | False | | |
| → | CTRI/2021/05/033904 | 7 September 2021 | To Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Mild Corona virus Disease (COVID-19) | A Prospective, Randomized, Parallel, Multi-centric, Open label, Phase III Clinical Trial to Evaluate the Efficacy and Safety of Molnupiravir Capsule in Treatment of Subjects with Mild Corona virus Disease (COVID-19) | | Ms MSN Laboratories Private Limited | 31-05-2021 | 20210531 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56239 | Recruiting | No | | | | 05-06-2021 | 1218 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | Mr C Devanpally→ | | Ardent Clincal Research Services
Office 304, Level 3, Gagan Kapital Biulding, Above Anna Idli restraunt, Opposite Hotel Kapila, Dhole Patil Road Pune -411001, Maharashtra India.
→ | krreddy@msnlabs.com→ | 914030438712→ | MSN Laboratories Pvt. Ltd→ | Inclusion criteria: 1. Male or female subjects of 18 years to 60 years both inclusive <br/ ><br>2. Subject and/or his/her legally accepted representative willing to give written informed <br/ ><br>consent. <br/ ><br>3. Subjects with laboratory confirmation of infection with SARS-CoV-2 by positive RTPCR <br/ ><br>(within 48 hours prior to randomization). <br/ ><br>4 Subjects having mild grade of COVID-19 as per MoH & FW guidelines on â??Clinical <br/ ><br>Management Protocol: COVID-19â?? as updated from time to time. <br/ ><br>a. Mild COVID-19: Patients with uncomplicated upper respiratory tract infection, <br/ ><br>may have mild symptoms such as fever, cough, sore throat, nasal congestion, <br/ ><br>malaise, headache, without evidence of breathlessness or hypoxia (normal <br/ ><br>saturation). (Time for symptom onset and baseline should be no more than 7 <br/ ><br>days).→ | Exclusion criteria: 1.Subject with history of hypersensitivity to Molnupiravir or to any of the excipient. <br/ ><br>2.Subjects with Moderate COVID-19: Pneumonia with no signs of severe disease, with presence of clinical features of dyspnoea and or hypoxia, fever, cough, including SpO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute <br/ ><br> <br/ ><br>3.Subjects with history of chronic liver disease (Child Pugh class B or C), severe liver disease like underlying liver cirrhosis or alanine aminotransferase (ALT)/aspartate aminotransferase (AST) elevated over 3 times the ULN and chronic renal disease (creatinine clearance (CrCl) <30ml/min). <br/ ><br>4.Refractory nausea, vomiting, or chronic gastrointestinal disorders, inability to swallow the study drug or having undergone extensive bowel resection which may affect adequate absorption of Molnupiravir. <br/ ><br> <br/ ><br>5.Pregnant or breast-feeding subjects will be excluded. <br/ ><br>6.Subject currently using adrenocorticosteroids (except topical or inhaled preparations) or immunosuppressive or immunomodulatory drugs (e.g., immunosuppressants, anticancer drugs, interleukins, interleukin antagonists or interleukin receptor blockers). <br/ ><br>7.Subjects on other antiviral or hydroxychloroquine within 4 weeks from screening. <br/ ><br>8.Subject has history of any serious chronic disease (e.g., human immunodeficiency virus (HIV); cancer requiring chemotherapy within the preceding 6 months; unstable cardiac, pulmonary, neurologic, vascular, or endocrinologic disease states requiring medication dose adjustments within the last 30 days. <br/ ><br>9.Subject has a history of alcohol or drug abuse in the previous 6 months. <br/ ><br>10.Subject has a psychiatric disease that is not well controlled where controlled is defined as: stable on a regimen for more than one year. <br/ ><br>11.Subject already treated with another COVID 19 therapy but has relapsed with a positive diagnosis. <br/ ><br>12.Anticipated transfer to another hospital which is not a study site within 72 hours. <br/ ><br>13.Participated in any other clinical trial or taken investigational drug within 1 month. <br/ ><br>14.Any serious medical condition or evidence of multi organ failure or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the subjectâ??s safe participation in and completion of the study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Molnupiravir 200 mg: 4 capsules of Molnupiravir 200 mg Twice daily for 5 days will be administered in the IP arm to 609 Covid 19 mild patients.<br>Control Intervention1: Standard of Care for Covid 19 Management: Standard of Care treatment shall be based on the Clinical Guidance for Management of<br>Adult COVID-19 Patients, dated 22 Apr 2021. AIIMS/ ICMR-COVID-19 National Task<br>Force/Joint Monitoring Group (Dte. GHS) and recommendations of Ministry of Health and<br>Family Welfare, Government of India.<br>→ | To evaluate the efficacy of Molnupiravir Capsule compared to standard of care in confirmed RT-PCR positive patients with mild Coronavirus Disease of 2019 (COVID-19).Timepoint: -Rate of hospitalization from randomization up to Day 14→ | | | | Yes | False | | |
| → | CTRI/2021/06/033911 | 7 September 2021 | Low Dose Radiotherapy for COVID-19 Pneumonia using a Linear accelerator | Low Dose Radiotherapy for COVID-19 Pneumonia using a Linear accelerator: Proposal for a prospective trial | | Guru Hospitals | 01-06-2021 | 20210601 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56430 | Not Recruiting | No | | | | 05-06-2021 | 106 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 2 | India→ | Murugesh linga perumal→ | | Department of Radiation Oncology,
4 /120-F, Pandikovilring Road, Airport â?? Mattuthavani Ring Rd, Madurai → | murugeshlp@yahoo.co.in→ | 9790987623→ | Guru Hospital→ | Inclusion criteria: 1.Patients with confirmed diagnosis of SARS-Cov2 infection by RT-PCR on nasopharyngeal swab and / or bronchoalveolar lavage (BAL) <br/ ><br>2.moderate to severe dyspnoea, respiratory frequency â?¥ 30/min, oxygen saturation with supplemental O2 supply (SpO2) < 92%, PaO2/FiO2 ratio or PaFiO2 ratio between 200 to 300 or SpO2/FiO2 ratio < 315 if PaO2 is not available <br/ ><br>3.laboratory abnormalities such as C-reactive protein (CRP) >100 mg/L, D-dimer >1000 ng/ml, IL-6 >40 IU or suspected cytokine release syndrome. <br/ ><br>4.first and second criteria are mandatory and third is optional <br/ ><br>→ | Exclusion criteria: 1.Prior lobectomy or pneumonectomy <br/ ><br>2.contraindication to radiation (Example: Known hereditary syndrome with increased sensitivity to ionizing radiation, e.g., ataxia-telangiectasia or Fanconi anemia) <br/ ><br>3.previous history of radiation to thoracic organs <br/ ><br>4.Prior chemotherapy or other systemic therapy with potential for pulmonary toxicity or radio sensitization within 14 days or 5 half-lives, whichever is greater, of enrollment, e.g., bleomycin, gemcitabine <br/ ><br>5.Severe pre-existing heart disease, e.g., New York Heart Association (NYHA) functional class â?¥ 3 congestive heart failure <br/ ><br>6.Pregnancy.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Low Dose Radiation therapy in<br>addition to standard<br>of care: The patients will be made to lie on a flat couch in comfortable position. A check portal image will be taken prior to treatment for checking the treatment field. <br>The patientâ??s vertical separation will be taken. The target volume of treatment is bilateral lungs. <br>All patients will receive a single dose of 0.5 Gy and in the case of non-efficacy and at the discretion of the researcher another 0.5 Gy dose will be repeated 48-72 hours later. <br>This low dose radiation treatment is an additional treatment apart from the routine pharmacological treatment for COVID19.<br><br>Control Intervention1: Standard of Care: Pharmacological therapy based<br>on guidelines issued by competent authorities.<br>→ | The primary end-point will be to evaluate the efficacy of low-dose pulmonary irradiation using a Linear accelerator as an adjunctive treatment for patients with COVID-19 pneumonia by improving the PaO2-FiO2 by 20% measured 48-72h after treatment with respect to baseline pre-irradiation measurement.Timepoint: 48-72h after treatment→ | | | | Yes | False | | |
| → | CTRI/2021/06/033912 | 7 September 2021 | A clinical trial to study the impact of low dose radiation to the lungs in patients with moderate COVID Pneumonia. | Study of Impact of adding Low Dose Pulmonary Radiotherapy to Moderate COVID-19 pneumonia patients. - IMpaCt-RT | | All India Institute of Medical Sciences Patna | 01-06-2021 | 20210601 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56424 | Not Recruiting | No | | | | 07-06-2021 | 22 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Pritanjali singh→ | | Department of Radiotherapy, LGB , OPD Block, All India Institute of Medical Sciences ,Patna. 13/14, Vandana Apartment , Rajendra Nagar Patna 800016→ | drpritanjalis@aiimspatna.org→ | 09334931395→ | All India Institute of Medical Sciences Patna.→ | Inclusion criteria: 1) Age â?¥ 18 years <br/ ><br>2) Patients with confirmed diagnosis of SARS-Cov2 infection by RT-PCR on nasopharyngeal swab and / or bronchoalveolar lavage (BAL) <br/ ><br>3) Patients having MOHFW Moderate disease with SpO2 < 94% on Room Air and Respiratory rate > 20 Breaths per minute on Room Air with fewer than 8 days of symptom onset and currently receiving standard medication for COVID-19 at appropriate doses. Covid-19 classification criteria led down by MOHFW, Govt. Of India (Appendix 1) <br/ ><br>4) Suggestive picture finding for interstitial pneumonia on chest X-ray and / or chest CT (optional) <br/ ><br>5) Ability to understand and sign informed consent. <br/ ><br>6) Ability to acquire and maintain the set-up necessary for the delivery of radiotherapy treatment <br/ ><br>→ | Exclusion criteria: 1) Patients with MOHFW defined severe disease. <br/ ><br>2) Patients undergoing invasive mechanical ventilation. <br/ ><br>3) Patients with active autoimmune systemic diseases. <br/ ><br>4) Hemodynamically unstable patients. <br/ ><br>5) Patients with a positive pregnancy test. <br/ ><br>6) Impossibility to maintain the set-up necessary for radiotherapy treatment. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: D- Radiation Therapy
→ | Intervention1: Low dose Radiation.: Arm A will receive 0.7 Gy single fraction radiation to bilateral lungs along with institutional protocol.<br><br>Control Intervention1: No Radiation will be given only institutional protocol.: Arm B will be control arm where only institutional protocol will be followed.<br>→ | Primary objective: To evaluate change from moderate to severe grade of disease in both the group with NEWS-2 <br/ ><br> <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: Time Frame Day 1, Day 3, Day 7, Day 14 <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/06/033938 | 7 September 2021 | This study is to evaluate benefit of adding Molnupiravir over standard treatments in mild COVID-19 subjects | A Prospective, Randomized, Multicenter, Open Label, Parallel Group Study To Evaluate Safety And Efficacy Of Oral Molnupiravir As Add On To Standard Of Care For Treatment Of Mild Patients With Covid-19 Disease | | Dr Reddys Laboratories Limited | 01-06-2021 | 20210601 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56374 | Recruiting | No | | | | 11-06-2021 | 1218 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3 | India→ | Dr Shariq Anwar→ | | Tower 2, 1st Floor, South wing
L & T Business Park,
Plot no. 12/4 Sector 27 D
Delhi Mathura Road,Near Saraj Khwaja Metro Station
→ | sonika.newar@jssresearch.com→ | 918800799887→ | JSS Medical Research Asia Pacific Private Limited→ | Inclusion criteria: 1. Subjects will be enrolled in the study if they meet all the following criteria: <br/ ><br> <br/ ><br>2. Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements <br/ ><br> <br/ ><br>3. Male or female patients between 18 and 60 years of age (both inclusive) <br/ ><br> <br/ ><br>4. Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected â?¤5 days prior to randomization) <br/ ><br> <br/ ><br>5. Note: If rapid antigen test has been performed and patient found positive then RT-PCR will be performed prior to randomization. <br/ ><br> <br/ ><br>6. Patients with mild COVID-19 and have following symptoms and signs prior to randomization â?¤5 days prior to randomization <br/ ><br> <br/ ><br>7. Upper respiratory tract symptoms (&/or fever) without shortness of breath or hypoxia. <br/ ><br> <br/ ><br>8. As defined by AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring Group (Directorate General Of Health Services) Ministry of Health & Family Welfare, Government of India- clinical guidance for management of adult COVID-19 patients, dated 22-Apr-2021. <br/ ><br> <br/ ><br>9. Is willing and able to take oral medication <br/ ><br> <br/ ><br>10. Willingness to comply with study instructions for its duration as indicated by written informed consent from the patient <br/ ><br> <br/ ><br>→ | Exclusion criteria: Subjects will be entered into the study only if they meet none of the following criteria <br/ ><br> <br/ ><br>1. Is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization <br/ ><br> <br/ ><br>2. Pregnancy or lactation <br/ ><br> <br/ ><br>3. History of allergy or hypersensitivity to Molnupiravir or any other treatment component based on investigators assessment <br/ ><br> <br/ ><br>4. Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation <br/ ><br> <br/ ><br>5. Tested positive for Human immunodeficiency virus (HIV), <br/ ><br> Hepatitis B virus (HBV) or Hepatitis C virus (HCV) infection <br/ ><br> <br/ ><br>6. Abnormal laboratory findings at screening <br/ ><br>Aspartate aminotransferase (AST) >3X upper limit of normal <br/ ><br>Alanine aminotransferase (ALT) >3X upper limit of normal <br/ ><br>Absolute neutrophil count <500/mm3 or per microliter <br/ ><br>Platelet count <100,000 per microliter or /mm3 <br/ ><br>Patients who received a platelet transfusion in the 5 days prior to randomization <br/ ><br> <br/ ><br>7. Has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: <br/ ><br> <br/ ><br>8. Participants who are not expected to survive longer than 48 hours at the time of randomization, or <br/ ><br>Participants with a recent history of mechanical ventilation, or <br/ ><br>Participants with conditions that could limit gastrointestinal absorption of capsule contents <br/ ><br> <br/ ><br>9. Receipt of following medication/treatment: <br/ ><br>Ongoing Remdesivir, Favipiravir or any other anti-viral drug, for COVID-19 treatment <br/ ><br>Biological therapy (especially, monoclonal antibody, interferon alpha) or convalescent plasma (for COVID-19 treatment) in the 90 days (prior to baseline visit) <br/ ><br> <br/ ><br>10. Participation in any clinical study with an investigational drug, biologic, or device within 1 month prior or within 5 half-lives (of the drug/ biologic) prior to the randomization (whichever is longer) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Molnupiravir Tablets 200mg: Molnupiravir Tablets 200mg (4 x 200mg), twice a day for 5 days before food intake<br>Control Intervention1: Standard of care: Standard of Care<br>→ | Rate of hospitalizationTimepoint: Randomization up to Day 14→ | | | | Yes | False | | |
| → | CTRI/2021/06/033943 | 7 September 2021 | Hearing evaluation in COVID 19 recovered patients | Audiological status in post COVID 19 recovered patients - nil | | Yenepoya Medical College | 02-06-2021 | 20210602 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53032 | Not Recruiting | No | | | | 16-06-2021 | 96 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DR HARSH A SURI→ | | Senior Resident in Otorhinolaryngology
Yenepoya Medical College Mangalore
Senior Resident in Otorhinolaryngology
Yenepoya Medical College Mangalore→ | harshsuri92@gmail.com→ | 9886273009→ | Yenepoya Medical College→ | Inclusion criteria: Subjects in the age group 18years to 50years who have recovered from COVID 19 infection who have either been treated or not with hydroxychloroquine→ | Exclusion criteria: Age above 50 years <br/ ><br>Middle ear disease <br/ ><br>Individual who have past history of hearing loss <br/ ><br>Diabetes mellitus <br/ ><br>Genetic disorders of hearing <br/ ><br>Congenital ear abnormalities→ | | Control Intervention1: NIL: NIL<br>→ | Percentage of COVID 19 survivors with hearing loss. <br/ ><br>Degree of hearing loss in COVID 19 survivors with use of hydroxychloroquine or without use of hydroxychloroquine.Timepoint: 18 months→ | | | | Yes | False | | |
| → | CTRI/2021/06/033948 | 7 September 2021 | The Non-interventional, retrospective, review to know effect of C21 on lung pathology. | (VP-C21-007) Non-interventional, retrospective, multi-center, follow-up study evaluating the effect of C21 on lung pathology in subjects previously hospitalised with COVID-19 and enrolled in the VP-C21-006 trial | | Vicore Pharma AB | 02-06-2021 | 20210602 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56514 | Recruiting | No | | | | 15-06-2021 | 30 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Mr Gajendra Chanchu→ | | Office number B-209, Westgate Besides YMCA Club S. G. Highway→ | yraghuvanshi@orphan-reach.com→ | 9619579849→ | QED Clinical Services India Private Limited→ | Inclusion criteria: 1) Written informed consent <br/ ><br>2) Previously included in the VP-C21-006 trial and received at least one dose of IMP <br/ ><br>3) Available record of at least one HRCT performed within 24 weeks after completion of VP-C21-006.→ | Exclusion criteria: 1) Participation in another interventional trial during the historical period covered by this study that could interfere with the study objectives or evaluation→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Averaged total lung score for both lungs (%) measured by per lung % scores based on ground glass opacity, reticulation, band opacity, fibrosis and consolidation, on HRCT performed up to 24 weeks after completion of VP-C21-006Timepoint: Baseline <br/ ><br>24 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/06/033949 | 7 September 2021 | COVID SECOND WAVE | Ocular sequelae of second wave of COVID-19 - COVID SEQUELAE | | NIL | 02-06-2021 | 20210602 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56535 | Not Recruiting | No | | | | 15-06-2021 | 116 | Observational | Single Arm Trial<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Ritu Arora→ | | Room no 215,Guru Nanak Eye Center
Maulana Azad Medical College
Department of Ophtha;mology
Bahadur Shah Zafar Marg
New Delhi → | dr_rituarora@yahoo.com→ | 9968604331→ | Maulana Azad Medical College→ | Inclusion criteria: Severe COVID-19 recovered patients (https://www.mohfw.gov.in/pdf/UpdatedClinicalManagementProtocolforCOVID19dated03072020.pdf) patients <br/ ><br>Treated at LN hospital, New Delhi <br/ ><br>At least 2 weeks after discharge <br/ ><br>Naso-pharyngeal swab RT-PCR negative <br/ ><br>ï?· 18 years→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Presence of Ocular finding related to COVID-19Timepoint: 2 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/06/033967 | 7 September 2021 | COVID - antibody surveillance among Healthcare workers | Immune Response following COVID 19 vaccination among healthcare workers in a tertiary care center in South India â?? A Cross sectional study | | Institution MOSC Medical College Hospital Kolenchery Ernakulam | 03-06-2021 | 20210603 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55260 | Not Recruiting | No | | | | 15-06-2021 | 32 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | N/A | India→ | Dr Ajith Venugopalan→ | | MOSC Medical College Hospital, Kolenchery, Ernakulam, Kerala 682311
KERALA
India Nedumpilly Bunglow, Ponekkara, AIMS Ponekkara P.O., Cochin 682041
Ernakulam
KERALA
682041
India→ | ajith.v123@gmail.com→ | 9496339347→ | MOSC Medical College Hospital, Kolenchery→ | Inclusion criteria: 1. All persons who have taken Anti-SARS-CoV-2 IgG level prior to the complete dose (2nd dose) of COVID 19 vaccination. <br/ ><br>2. Vaccine shall be COVISHIELD <br/ ><br>→ | Exclusion criteria: 1. Those not completed the 2 dose of vaccination→ | | Control Intervention1: Nil: Nil<br>→ | Antibody response post 2nd dose of covid vaccinationTimepoint: After 4 weeks <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/06/033979 | 7 September 2021 | The role of NIV in COVID 19 patinets | The Outcomes Of Using Non Invasive Ventilation (NIV) In COVID 19 Patients On Mechanical Ventilation â??
A Descriptive Cross Sectional Study
| | Government medical College Baroda | 03-06-2021 | 20210603 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54456 | Not Recruiting | No | | | | 09-06-2021 | 50 | Observational | Single Arm Trial<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | Phase 2/ Phase 3 | India→ | Dr Swati Bhatt→ | | Department of anesthesiology
Government medical College Baroda → | drswatibhatt2015@yahoo.com→ | | Government medical College Baroda→ | Inclusion criteria: 1. Age more than 18 years <br/ ><br>2. Both Gender <br/ ><br>3. Following Symptoms and signs: <br/ ><br>a) breathlessness at rest; <br/ ><br>b) RR > 30 /min, use of accessory respiratory muscles, paradoxical <br/ ><br>breathing. <br/ ><br>c) SpO2 <90% <br/ ><br>4. ABG Analysis : a) pH < 7.35; PaO2 <80mm Hg PaCO2 > 45 mm Hg. Art., <br/ ><br>b) PaO2/FiO2 <300→ | Exclusion criteria: 1. Signs of altered consciousness <br/ ><br>2. Unstable hemodynamics <br/ ><br>3. Inability to protect the respiratory tract. (absence/diminished <br/ ><br>protective airway reflexes) <br/ ><br>4. Excessive bronchial secretion. <br/ ><br>5. Uncooperative patients. <br/ ><br>6.Facial trauma, burns, anatomical disorders that prevent masking <br/ ><br>7.Patients with uncontrolled DM and/or HTN→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J00-J99- Diseases of the respiratory system
→ | | To determine the outcome after using NIV in COVID 19 patients <br/ ><br>Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/06/033980 | 7 September 2021 | NOQ19 trial for treatment of COVID 19 | A study of efficacy of NOQ19 with standard of care in adults with COVID-19 infection: A randomized, double-blind placebo-controlled clinical trial | | Ved Vignan Maha Vidya Peeth Sri Sri Institute of Advanced Research | 03-06-2021 | 20210603 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56586 | Not Recruiting | No | | | | 11-06-2021 | 3240 | Interventional | Other<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3/ Phase 4 | India→ | Dr Archana Patel→ | | Lata Medical Research Foundation, 9/1, Vasant Nagar, Nagpur 440022, M.S → | dr_apatel@yahoo.com→ | 09823350019→ | Lata Medical Research Foundation→ | Inclusion criteria: Screened participants with â??Yesâ?? answer to all the following questions will be eligible to take part in the study: <br/ ><br>a) Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR positive test in sample collected <72 hours prior to randomization. RT-PCR Positive in sample collected > 72 hours prior to randomization with inability to obtain repeat sample and progressive disease suggestive of ongoing SARS-CoV-2 infection. <br/ ><br>(b) Illness of any duration and considered as SARS-CoV-2 infection by physician on HRCT scan or clinically on SpO2levels requiring supplemental oxygen or ventilation or Rapid Antigen test <br/ ><br>(c) Male or non-pregnant female adult â?¥18 years of age at time of enrollment <br/ ><br>(d) Subject (or legally authorized representative)provides informed consent prior to initiation of any study procedures <br/ ><br>(e) Subject (or legally authorized representative)understands and agrees to comply with planned study procedures <br/ ><br>(f) No contraindications to NOQ19 â?? Ayurvedic Proprietary Medicine, such as allergy. <br/ ><br> <br/ ><br>Close contact eligibility: All possible eligible contacts willing to participate in the study and provide written consent to follow the study protocol will be tested using RT-PCR for the contact sub-study. If a close contact is positive then they will be screened for eligibility in the main study (Figure 1). If the close contacts are negative then they will be eligible for the contact sub-study, provided they have no contraindications for herbal medications, history of gastritis or peptic ulcer. <br/ ><br>→ | Exclusion criteria: Screened patients with â??Yesâ?? answer to any of the following questions will not be eligible to participate in the study: <br/ ><br>(a) Treating physician considers the patient unfit to administer the intervention (eg. Severe cases with Intubation, on ventilator, multi-organ failure) <br/ ><br>(b) History of recent gastritis, peptic ulcer or hematemesis <br/ ><br>(c) Enrolled in another trial <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J988- Other specified respiratory disorders
→ | Intervention1: NOQ19 â?? Ayurvedic Proprietary Medicine: Dosage: 1gm (2 tablets of 500 mg) thrice a day with lukewarm water given half hour after meals for minimum of 14 days (Intervention Arm)<br>Control Intervention1: Placebo: Dosage: two tablets thrice a day administered with lukewarm water given half hour after meals for minimum of 14 days (Control Arm)<br>→ | To test the efficacy (Time to Recovery) of NOQ19 with SoC compared to placebo with SoC in adult COVID-19 positive patients - evaluated separately for symptomatic and asymptomatic cases.Timepoint: Upto Day 28→ | | | | Yes | False | | |
| → | CTRI/2021/06/033992 | 7 September 2021 | A clinical study to estimate the efficacy and safety of formulation of Molnupiravir in patients with Mild COVID-19 infection. | A prospective, randomized, parallel, multicentric, phase III clinical trial to assess the efficacy and safety of Molnupiravir 800 mg capsules and standard of care (soc) compared to standard of care (soc) only in patients with polymerase chain reaction (RT-PCR) confirmed Mild Covid-19 infection. | | Optimus Pharma Pvt Ltd | 04-06-2021 | 20210604 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56393 | Not Recruiting | No | | | | 05-06-2021 | 1218 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Saurabh Bhatia→ | | Tower 2, 1st Floor, South Wing,
L&T Business Park,
Plot no 12/4, Sector 27 D,
Delhi Mathura Road, Near Sarai Khawja Metro Station→ | shariq.anwar@jssresearch.com→ | 9810979215→ | JSS Medical Research Asia Pacific Private Limited→ | Inclusion criteria: 1. Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements. <br/ ><br> <br/ ><br>2. Male or female patients between 18 and 60 years of age (both inclusive). <br/ ><br> <br/ ><br>3. Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected â?¤5 days prior to randomization) Note: If rapid antigen test has been performed and patient found positive then RT-PCR will be performed prior to randomization. <br/ ><br> <br/ ><br>4. Patients with mild COVID-19 and have following symptoms and signs prior to randomization. <br/ ><br>Mild: Upper respiratory tract symptoms (&/or fever) without shortness of breath or hypoxia. <br/ ><br> <br/ ><br>5. Patients who are able to consume oral medications. <br/ ><br> <br/ ><br>6. Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ ><br>Refrain from donating sperm; and either abstain from sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception. <br/ ><br> <br/ ><br>7. Females who are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention. <br/ ><br>→ | Exclusion criteria: 1. Known hypersensitivity or contraindications to any of the components of <br/ ><br>the study interventions or to any other similar class of drugs as determined by the investigator. <br/ ><br> <br/ ><br>2. Uncontrolled comorbid medical conditions. <br/ ><br> <br/ ><br>3. Patient is currently hospitalized or is expected to need hospitalization <br/ ><br> for COVID-19 within 48 hours of randomization. <br/ ><br> <br/ ><br>4. Patient is on dialysis or has reduced estimated glomerular filtration rate (73m2eGFR) <30 mL/min/1 by the Modification of Diet in Renal Disease (MDRD) equation. <br/ ><br> <br/ ><br>5. If patient has any of the following conditions: human immunodeficiency virus (HIV); chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm3; autologous or allogeneic hematopoietic stem cell transplant recipient. <br/ ><br> <br/ ><br>6. If patient has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening. <br/ ><br> <br/ ><br>7. If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. <br/ ><br> <br/ ><br>8. Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. <br/ ><br> <br/ ><br>9. Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, Oseltamivir, Remdesivir or any other anti-viral treatments) during study participation as per investigatorâ??s discretion. <br/ ><br> <br/ ><br>10. A baseline heart rate of < 60 beats per minute at rest. <br/ ><br> <br/ ><br>11. If patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Molnupiravir 800 mg (4x200 mg or 2x400 mg) capsules twice a day (BID) for 5 days plus standard of care (SOC): Patients will be instructed to to take Molnupiravir 800 mg capsules twice a day (morning and evening) orally one hour before food intake with a glass of water for 5 days<br>Control Intervention1: Standard of Care (SOC) only: Standard of Care (SOC) only<br>→ | To evaluate the efficacy of Molnupiravir to standard of care in confirmed RT-PCR positive patients with Mild COVID-19Timepoint: Day 1 to Day 5 <br/ ><br> <br/ ><br>RT-PCR will be evaluated on screening, end of treatment day (plus 1) or at the time of early discontinuation. <br/ ><br> <br/ ><br>Note: If RT-PCR test is found to be positive for Day 5 (plus 1) sample, the test may be repeated on Day 10 and on Day 14, if it was positive on Day 10 <br/ ><br> <br/ ><br>Post treatment follow-up Day 10, Day 14(plus 1 Day), 28 Day ( plus 1 Day) <br/ ><br> <br/ ><br>Rate of hospitalization from randomization up to day 14→ | | | | Yes | False | | |
| → | CTRI/2021/06/033993 | 7 September 2021 | Adverse Events following COVID 19 Vaccination | Adverse Events following COVID 19 Vaccination among healthcare workers in a tertiary care center in South India â?? A Cross sectional study | | Institution MOSC Medical College Hospital Kolenchery Ernakulam | 04-06-2021 | 20210604 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54923 | Not Recruiting | No | | | | 20-06-2021 | 468 | Observational | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | N/A | India→ | Dr Ajith Venugopalan→ | | MOSC Medical College Hospital, Kolenchery, Ernakulam, Kerala 682311 Nedumpilly Bunglow, Ponekkara, AIMS Ponekkara P.O., Cochin 682041→ | ajith.v123@gmail.com→ | 9496339347→ | MOSC Medical College Hospital, Kolenchery→ | Inclusion criteria: (1) All COVID 19 vaccinated above the age of 18 years <br/ ><br>(2) Vaccine shall be COVISHIELD <br/ ><br>→ | Exclusion criteria: (1) Adverse events following COVID 19 vaccination occurring after 7 days of vaccination→ | | Control Intervention1: Nil: Nil<br>→ | Adverse Events following COVID 19 VaccinationTimepoint: within 7 days→ | | | | Yes | False | | |
| → | CTRI/2021/06/034001 | 7 September 2021 | A clinical trial to prove the benefit of low dose X-rays to lungs in treating COVID-19 disease | Efficacy of low dose lung radiotherapy in the management of Covid-19 patients | | Sri Venkateswara Institute of Medical Sciences | 04-06-2021 | 20210604 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56672 | Not Recruiting | No | | | | 12-06-2021 | 66 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 2 | India→ | Dinakar Kootala→ | | Department of Radiotherapy, Sri Venkateswara Institute of Medical Sciences (SVIMS), Alipiri road, Tirupati Department of Radiotherapy, Sri Venkateswara Institute of Medical Sciences (SVIMS), Alipiri road, Tirupati 517501→ | dinakarkmc1@gmail.com→ | 8897444722→ | Sri Venkateswara Institute of Medical Sciences (SVIMS)→ | Inclusion criteria: 1.Age 40 years or more and 2. Patients confirmed to have COVID-19 based on a positive RT_PCR for SARS CoV-2 and have been admitted to the hospital and 3. patients with any of a. PaO2/FiO2 between 100mmHg and 300mmHg or b. Respiratory rate >24per min or more, breathlessness or c. SpO2 <94% on room air and 4. Lung parenchymal involvement at baseline CT scan→ | Exclusion criteria: 1.Pregnancy and lactating mother <br/ ><br>2.Prior thoracic radiation or chemotherapy with potential for pulmonary toxicity <br/ ><br>3.Prior or planned treatment with interleukin inhibitors or TNF-α inhibitors <br/ ><br>4.History of collagen vascular disease <br/ ><br>5.Chronic lung diseases (Chronic obstructive lung disease, bronchial asthma), history of pulmonary tuberculosis <br/ ><br>6.Inability to lie in supine on a flat couch with oxygen supplementation for radiation planning and delivery <br/ ><br>7.Patients with PaO2/FiO2 <100 (severe ARDS) and/or on mechanical ventilation <br/ ><br>8.Patients who are not willing to participate in the study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Low Dose Radiation therapy in addition to standard of care as per ICMR guidelines: Low dose radiation to a dose of 0.5Gy in single fraction with AP-PA fields using CT based planning on a Linear Accelerator in addition to pharmacological therapy as per ICMR guidelines;India . Dexamethasone 6mg IV Once daily for 10 days (Alternative: Methylprednisolone 80mg IV BD for 10 days) Enoxiparin 60mgs/c Once Daily for 5 days (dose adjusted based on D-dimer levels), Remdesvir 200mg IV Once daily on day 1 followed by 100mg IV Once daily for next 4 days, further continuance based on clinical response,Vitamin D 60,000U /week, Vitamin C 1500 mg/day, Zinc, Paracetamol, Anti-tussives, Antibiotics, Oxygen supplementation. Adjunctive therapies : IV thiamine,IV vitamin C, N acetyl cysteine, Ulinastatin, Sepsivac (mycobacterium w), high dose statins. Salvage therapies : Pulse therapy of steroids, Cytosorb-hemoperfusion, Pirfenidone, Alteplase. The pharmacologic therapy is individualized on a case by case basis<br>Control Intervention1: Standard of care as per ICMR guidelines: Pharmacological therapy as per ICMR guidelines;India. Dexamethasone 6mg IV Once daily for 10 days (Alternative: Methylprednisolone 80mg IV BD for 10 days) Enoxiparin 60mgs/c Once Daily for 5 days (dose adjusted based on D-dimer levels), Remdesvir 200mg IV Once daily on day 1 followed by 100mg IV Once daily for next 4 days, further continuance based on clinical response,Vitamin D 60,000U /week, Vitamin C 1500 mg/day, Zinc, Paracetamol, Anti-tussives, Antibiotics, Oxygen supplementation. Adjunctive therapies : IV thiamine,IV vitamin C, N acetyl cysteine, Ulinastatin, Sepsivac (mycobacterium w), high dose statins. Salvage therapies : Pulse therapy of steroids, Cytosorb-hemoperfusion, Pirfenidone,Alteplase. Th→ | The primary outcome of the study will be a composite of progression to severe disease (PaO2/FiO2 ratio less than 100mmHg) any time within 28 days of enrolment or all cause mortality at 28 days. If progression to severe disease or all cause mortality could be prevented in the 28 days post-enrolment, the primary outcome will be considered as â??goodâ?? and if not it will be considered â??poorâ??.Timepoint: The primary outcome of the study will be a composite of progression to severe disease (PaO2/FiO2 ratio less than 100mmHg) any time within 28 days of enrolment or all cause mortality at 28 days. If progression to severe disease or all cause mortality could be prevented in the 28 days post-enrolment, the primary outcome will be considered as â??goodâ?? and if not it will be considered â??poorâ??.→ | | | | Yes | False | | |
| → | CTRI/2021/06/034014 | 7 September 2021 | Biological Eâ??s CORBEVAX vaccine clinical study for protection against Covid-19 disease. | A Prospective, multicentre, Phase II Seamlessly Followed by Phase III Clinical Study to Evaluate the Immunogenicity and Safety of Biological Eâ??s CORBEVAX Vaccine for Protection Against COVID-19 Disease When Administered to COVID-19-Negative Adult Subjects. - None | | Biological ELimited | 04-06-2021 | 20210604 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56379 | Recruiting | No | | | | 07-06-2021 | 1268 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr TSA Kishore→ | | Clinical Development Dept, 2nd floor, Road No.35, Jubilee Hills → | subhash.thuluva@biologicale.com→ | 04071216248→ | Biological E.Limited→ | Inclusion criteria: Inclusion Criteria ONLY for Phase II: <br/ ><br>1.Male or female (non-pregnant) subject between â?¥ 18 to 55 years of age. <br/ ><br>2.Subject seronegative to anti-SARS-CoV-2 antibody prior to enrolment. <br/ ><br>Inclusion Criteria ONLY for Phase III: <br/ ><br>1.Male or female subject between â?¥ 18 to 80 years of age. <br/ ><br>Inclusion Criteria for Phase II and Phase III: <br/ ><br>1.Subject or their legally acceptable representative (LAR) is willing to provide a written informed consent for voluntary participation in the study. <br/ ><br>2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol. <br/ ><br>3.Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment. <br/ ><br>4.Subject is seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ ><br>5.Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination. <br/ ><br>6.Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination in the study. <br/ ><br>7.Male subject, who is sexually active, must agree to use double-barrier contraception (e.g. condom with spermicide) with his female partner during the study period. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration. <br/ ><br>8.Subject agrees not to participate in another clinical trial at any time during the total study period. <br/ ><br>9.Subject agrees to refrain from blood donation during the course of the study. <br/ ><br>10.Subject agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ ><br> <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1.History of vaccination with any investigational or approved vaccine against COVID-19 disease. <br/ ><br>2.Subject living in the same household as that of any active COVID-19 positive individual at the time of enrolment. <br/ ><br>3.History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines); <br/ ><br>4.Subjects with any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator. <br/ ><br>5.Subjects with Body temperature of â?¥100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination. <br/ ><br>6.Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during the study. <br/ ><br>7.Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study: <br/ ><br>i.severe psychiatric conditions; <br/ ><br>ii.any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder); <br/ ><br>iii.allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE CORBEVAX vaccine); <br/ ><br>iv.neurological illness, and any other serious chronic illness requiring hospital specialist supervision. <br/ ><br>8.Subjects requiring chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. <br/ ><br>i.For corticosteroids, this will mean prednisone â?¥0.5 mg/kg/day, or equivalent. <br/ ><br>ii.Inhaled and topical steroids are allowed. <br/ ><br>iii.Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data. <br/ ><br>9.Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). <br/ ><br>10.Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ ><br>11.Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment. <br/ ><br>12.Current or planned participation in prophylactic drug trials for the duration of the study. <br/ ><br>13.Individuals who are part of the study team or close family members of individuals conducting the study. <br/ ><br>→ | | Intervention1: Biological Eâ??s SARS-CoV-2 (COVID-19)Vaccine- CORBEVAX: Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses at Day 0 and Day 28.<br>Control Intervention1: None: None<br>→ | 1.Proportion of subjects with solicited adverse reactions/symptoms <br/ ><br>2.Proportion of subjects with unsolicited adverse events (AEs) <br/ ><br>3.SAEs & MAAE in all subjects. <br/ ><br>1.Anti-RBD IgG antibodies in terms of ratio of IgG1 to IgG4 anti-RBD titres. <br/ ><br>2.Neutralizing antibody titre <br/ ><br>3.Immunogenicity in terms of GMC/T <br/ ><br>4.Proportion of subjects seroconverted in terms of â?¥2-fold & â?¥4-fold rise <br/ ><br>5.Cell mediated immunity assessment in terms of cytokine expression from stimulated PBMCs (INF-γ, IL-4) <br/ ><br>Timepoint: 1.during first 60 minutes of post vaccination and subsequent 7 days. <br/ ><br>2.28-day follow-up period after each dose. <br/ ><br>3.At 6 and 12months post 2nd dose. <br/ ><br>1.at day 42 vs baseline. <br/ ><br>2.at baseline and again at day 42. <br/ ><br>3.at baseline and again at day 42. <br/ ><br>4.in baseline seronegative subjects and â?¥2-fold rise in baseline seropositive subjects along with their GMFR at day 42 <br/ ><br>5.at baseline and at day 42→ | | | | Yes | False | | |
| → | CTRI/2021/06/034015 | 7 September 2021 | A Clinical Study with Molnupiravir Capsules 800mg in COVID-19 Patients with Mild symptoms. | A Multi-Centre, Prospective, Open Label, Parallel, Randomized, Clinical Trial to
Assess the Efficacy And Safety Of Molnupiravir 800 Mg Capsules And Standard of Care
(SoC) Compared To Standard of Care (SoC) Only In Mild Patients With Polymerase Chain Reaction (PCR)
Confirmed COVID-19.
| | Strides Pharma Science Limited | 05-06-2021 | 20210605 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56699 | Recruiting | No | | | | 13-06-2021 | 1220 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | Dr Vimla Dsouza→ | | 19/2, SKR Towers, 15th Cross Rd, Dollar Layout, 4th Phase, J. P. Nagar,
Bengaluru
→ | Vimla.Dsouza@arcolab.com→ | 9844224041→ | Arcolab Pvt Ltd→ | Inclusion criteria: Patients willing and able to provide voluntary written informed consent and to follow the protocol requirements. <br/ ><br>Male or female patients between 18 and 60 years of age (both inclusive). <br/ ><br>Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or oropharyngeal swabs (sample collected â?¤5 days prior to randomization) <br/ ><br>Patients with mild COVID-19 (non-hospitalized) and have following symptoms and signs within 3 to 5 days prior to randomization. <br/ ><br>Patients having mild COVID-19 with a score of 2 or 3 on the 10-point ordinal scale of clinical status <br/ ><br>Patients who are able to consume oral medications. <br/ ><br>Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ ><br>Females who are not pregnant or breastfeeding <br/ ><br>→ | Exclusion criteria: Known hypersensitivity or contraindications to any of the components of the study interventions or to any other similar class of drugs as determined by the investigator. <br/ ><br>Uncontrolled comorbid medical conditions. <br/ ><br>Patient is currently hospitalized or is expected to need hospitalization for COVID-19 within 48 hours of randomization <br/ ><br>Patient is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation. <br/ ><br>If patient has any of the following conditions: human immunodeficiency virus (HIV); chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm3; autologous or allogeneic hematopoietic stem cell transplant recipient. <br/ ><br>If patient has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening. <br/ ><br>If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. <br/ ><br>Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. <br/ ><br>Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, oseltamivir or any other anti-viral treatments) during study participation as per investigatorâ??s discretion. <br/ ><br>A baseline heart rate of < 60 beats per minute at rest <br/ ><br>If patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could limit gastrointestinal absorption of capsule contents. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Molnupiravir 800 mg capsules: Molnupiravir 800 mg (4 capsules of 200 mg or 2 capsules of 400 mg) (BID) + Standard of care.<br>Patients will be instructed to take Molnupiravir 800 mg (4 x 200 mg or 2 x 400 mg) capsules every 12 hours, for 5 days-10 doses total) orally one hour before food intake with a glass of water.<br>Control Intervention1: Standard of Care: The standard of care will be as per physician recommendation or prescription in line to -Revised Guidelines on Clinical Management of COVID-19 by Government of India, Ministry of Health & Family Welfare Directorate General of Health Services, (EMR Division), Version 05, 03rd July 2020..<br>Treatment may include Oral medications like Ivermectin 12mg, once daily, anti-pyretic, anti-tussive multivitamins, and antibiotics<br>→ | Rate of hospitalization from randomization up to day 14.Timepoint: Rate of hospitalization from randomization up to day 14.→ | | | | Yes | False | | |
| → | CTRI/2021/06/034019 | 7 September 2021 | Post vaccination covid-19 infection rate in healthcare workers. | Post vaccination covid-19 infection rate in healthcare workers. - Post vaccination covid infection in hospital employees | | MPSRNU | 07-06-2021 | 20210607 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56469 | Not Recruiting | No | | | | 08-06-2021 | 500 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | RAVINDRA SABNIS→ | | A2/3, Muljibhai Patel Urological Hospital staff quarters, Civil hospital Road, Nadiad Urology Department, Main Building, second floor, Civil hospital road, Nadiad→ | rbsabnis@gmail.com→ | 09426422002→ | Muljibhai Patel Urological hospital→ | Inclusion criteria: All hospital employees were included in study which was voluntary & only after obtaining written consent to participate in project.→ | Exclusion criteria: Exclusion criteria â?? Those who did not take vaccine.→ | | | to find out post vaccination infection rate among healthcare workers.Timepoint: Outcome will be assessed at the time of taking the survey - minimum one week after vaccination.→ | | | | Yes | False | | |
| → | CTRI/2021/06/034055 | 7 September 2021 | Nutritional and inflammatory biomarkers in COVID-19 positive chronic kidney disease patients | Association between nutritional and inflammatory biomarkers in COVID-19 patients with chronic kidney disease | | Maulana Azad Medical College | 07-06-2021 | 20210607 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56609 | Not Recruiting | No | | | | 12-06-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Vatsala Khurana→ | | Room no. 205, Department of Biochemistry, Pathology Block, Maulana Azad Medical College,Bahadur Shah Zafar Marg, New Delhi → | smitakaushik77@yahoo.com→ | 9968604230→ | Maulana Azad Medical College, New Delhi→ | Inclusion criteria: All known cases of Chronic Kidney Disease more than 18 years of age, who have recently been diagnosed as COVID-19 positive by rRT-PCR→ | Exclusion criteria: COVID-19 negative by rRT-PCR cases of Chronic Kidney Disease→ | Health Condition 1: N184- Chronic kidney disease, stage 4 (severe)
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Association between nutritional and inflammatory biomarkers in COVID-19 patients with Chronic Kidney DiseaseTimepoint: baseline i.e. on day of admission→ | | | | Yes | False | | |
| → | CTRI/2021/06/034056 | 7 September 2021 | Acceptance and hesitation of the COVID-19 vaccine in South Indian districts: a mixed method study. | COVID-19 vaccine acceptance and hesitancy: A mixed method analysis of population in districts of South India. | | Priyobrat Rajkhowa | 07-06-2021 | 20210607 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56506 | Not Recruiting | No | | | | 15-06-2021 | 855 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Priyobrat Rajkhowa→ | | Prasanna School of Public Health(PSPH), MAHE, Manipal. Ground floor, Room number: 72
Department of Health Policy Prasanna School of Public Health, MAHE, Manipal, Udupi, 576104→ | asha.kamath@manipal.edu→ | 9606456067→ | Prasanna School of Public Health, MAHE→ | Inclusion criteria: a. Quantitative study: <br/ ><br>Inclusion <br/ ><br>â?¢ Age â?¥18 <br/ ><br>â?¢ Able to read or respond to questionnaires in English or Kannada <br/ ><br> <br/ ><br> <br/ ><br>b. Qualitative study: <br/ ><br>â?¢ Pre vaccine <br/ ><br>1. Age â?¥18 <br/ ><br>2. patients visiting medicine OPD from December 2020- January 2021. <br/ ><br>â?¢ Post vaccine <br/ ><br>1. Age â?¥18 <br/ ><br>2. Individuals who received COVID-19 vaccines from Kasturba Hospital, Manipal <br/ ><br> <br/ ><br>b) Biological materials required (type - blood, tissue, etc and quantity): NA <br/ ><br>→ | Exclusion criteria: Exclusion Quantitative study <br/ ><br> <br/ ><br>â?¢ Individuals who donâ??t have access to at least one of the communication devices such as telephone, mobile with social media and email→ | | | To identify the felt needs of community with regards to COVID-19 vaccinationTimepoint: At the baseline( while administering the questionnaires)→ | | | | Yes | False | | |
| → | CTRI/2021/06/034057 | 7 September 2021 | Study of antibodies in Babies born to mothers who are recovered from COVID 19 | A prospective Observation study to see the trends of SARS COVID 19 antibodies in newborns of seropositive mothers | | Sparsh Hospital Foundation | 07-06-2021 | 20210607 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56690 | Not Recruiting | No | | | | 30-06-2021 | 50 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | John Paul→ | | Number 606 ,15th Main MEI layout Hessaraghatta Main road Nagasandra Post bangalore Dept of infectious diseases ground floor room number 30 number 4/1 tumkur road yeshwanthpur bangalore 560022→ | drjohnpaulm@gmail.com→ | 8197290730→ | Sparsh super speciality Hospital→ | Inclusion criteria: All pregnant women who are infected with COVID 19 during the gestation period→ | Exclusion criteria: NA→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: O989- Unspecified maternal infectious and parasitic disease complicating pregnancy, childbirth and the puerperium
→ | | 1. To study the rate of transmission of maternal COVID Ig G antibodies to the neonate. <br/ ><br>2. To study the trend of maternally transmitted COVID Ig G antibodies in the neonate over the first seventy five days of life. <br/ ><br>Timepoint: first 75 days after the birth in a newborn. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/06/034061 | 7 September 2021 | Protective Effect of Nasal Drops in COVID Infection | Protective Efficacy of Anu Taila Nasya in Healthcare Professionals against SARS-CoV-2 (COVID-19) Infection:
A Double Blind Placebo Controlled Clinical Trial - NASALSHIELD | | All India Institute of Ayurveda | 07-06-2021 | 20210607 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56623 | Not Recruiting | No | | | | 15-06-2021 | 400 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Investigator Blinded | Phase 1 | India→ | Anandaraman Sharma PV→ | | Room No 704
Block-C
Mathura Road
Sarita Vihar → | namita@artemishospitals.com→ | 9716822224→ | Artemis Hospitals→ | Inclusion criteria: 1. Individuals 20-60 years of age. <br/ ><br>2. Healthy <br/ ><br>3. The participant must have normal hemogram, <br/ ><br>4. No systemic disease, <br/ ><br>5. Agree not to self-medicate with other potential antivirals during the course of the study. <br/ ><br>6. The participant must have the ability to use the product as directed <br/ ><br>7. Participant must have the willingness <br/ ><br>8. Participant must have ability to understand the nature of trial and the follow-up procedures.→ | Exclusion criteria: 1. History of COVID-19 infection within 90 days <br/ ><br>2. History of helminthic infection, <br/ ><br>3. History of diabetes or any other systemic disease <br/ ><br>4. Individuals who are symptomatic or convalescent. <br/ ><br>5. Individuals who are on other prophylactic/s <br/ ><br>6. Individuals who do not have the ability and willingness to use the product.→ | | Intervention1: Anu Taila: Application of TWO Drops of the medicated oil in each nostril twice a day for 28 days<br>Control Intervention1: Tila Taila: Application of TWO Drops of the oil in each nostril twice a day for 28 days<br>→ | Decrease in Viral LoadTimepoint: 28 days→ | | | | Yes | False | | |
| → | CTRI/2021/06/034064 | 7 September 2021 | Clinical Trial to assess benefit of adding Chlorpromazine to the current Standard of Care in treating patients who are moderately infected with COVID-19. Â
| A Phase II B III, Multi Centre Open label Randomized Controlled trial to assess Clinical Benefits of Chlorpromazine and Standard of Care Versus Standard of Care alone in the management of moderate SARS COV 2 infection - Nil | | CSIRIICT | 08-06-2021 | 20210608 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56459 | Recruiting | No | | | | 10-06-2021 | 176 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Centralized Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Mr Shriram Vedapuri→ | | ClinSync Clinical Research Pvt. Ltd. Clinical Trial Management Department, Third Floor, Room No. 301 JSR Mall,Plot no.7to18,Survery no.225,Opp, Mythri Nagar, Madeenaguda, Telangana ClinSync Clinical Research Pvt. Ltd. Clinical Trial Management Department,→ | attili@clinsynccro.com→ | 9246243034→ | ClinSync Clinical Research Pvt. Ltd.→ | Inclusion criteria: Documented COVID-19 infection as observed by positive RT-PCR for SARS-CoV-2 on the day of screening. <br/ ><br>Adult having moderate form of infection defined as presence of clinical features of dyspnea, and or hypoxia, fever, cough including spO2 <94% (range 90-94%) on room air, respiratory rate more or equal to 24 per minute <br/ ><br>→ | Exclusion criteria: Patients suffering from severe Covid-19 disease as per the physicianâ??s discretion. <br/ ><br> <br/ ><br>History of Chronic illness will be obtained and those with a history of active, ongoing disease will be excluded.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Chlorpromazine tablet oral: Chlorpromazine 25mg BD Oral for 10 days,50mg BD Oral for 10 days,100mg BD Oral for 10 days<br>Control Intervention1: Not applicable: Not Applicable<br>→ | Time To Response TTR measured as the number of days since randomization in which there is reduction of at least one severity level of the disease measured using a World Health Organization 8 Point Ordinal Scale for Clinical Improvement WHO OSCI.Timepoint: Baseline and 3 weeks (21 days)→ | | | | Yes | False | | |
| → | CTRI/2021/06/034065 | 7 September 2021 | Cardiovascular disease manifestations in COVID-19 patients | Cardiovascular disease manifestations with special emphasis on myocarditis-in moderate to severe COVID-19 patients undergoing treatment in the ccu of a tertiary care hospital in West Bengal India | | Dr Swati Datta | 08-06-2021 | 20210608 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56169 | Not Recruiting | No | | | | 09-06-2021 | 382 | Observational | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Not Applicable | N/A | India→ | Dr Swati Datta→ | | Department - Anaesthesiology
Division - Green Building
Room - 2nd floor, Tutor room no. 1 88 College Street
Kolkata - 700073
West Bengal, India→ | drsiahiri11@gmail.com→ | 9836979351→ | Medical College, Kolkata→ | Inclusion criteria: Case <br/ ><br>1. Age more than 18 years <br/ ><br>2. Laboratory confirmed COVID-19 patients <br/ ><br>3. SpO2 less than 94% <br/ ><br>4. Patients on different modalities of oxygen therapy <br/ ><br>5. Patients with radiologically confirmed pneumonia <br/ ><br>6. ARDS or Acute Respiratory Failure <br/ ><br>Control <br/ ><br>1. Age more than 18 years <br/ ><br>2. COVID-19 RTPCR negative <br/ ><br>3. SpO2 less than 94% <br/ ><br>4. Patients on different modalities of oxygen therapy <br/ ><br>5. Patients with radiologically confirmed pneumonia <br/ ><br>6. ARDS or Acute Respiratory Failure <br/ ><br>Control→ | Exclusion criteria: 1. Moribund patient with septicemia with or without multiorgan dysfunction <br/ ><br>2. Patient unwilling to participate in the study→ | Health Condition 1: B99-B99- Other infectious diseases
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | 1. Need for mechanical ventilation <br/ ><br>2. Length of CCU stay <br/ ><br>3. Length of hospitalization <br/ ><br>4. Incidence of arrhythmia, cardiac arrest during CCU stay <br/ ><br>5. Final outcome-discharge or deathTimepoint: Within 28 days from CCU admission→ | | | | Yes | False | | |
| → | CTRI/2021/06/034103 | 7 September 2021 | Siddha method of urine test to diagnose COVID-19 patients | DOCUMENTATION, CLINICAL VALIDATION AND EXPLORING THE EFFICACY OF â??NEERKURI AND NEIKURI" - URINE ANALYSIS OF COVID 19 CASES | | Ministry of AYUSH | 09-06-2021 | 20210609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=43199 | Recruiting | No | | | | 18-07-2021 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:Case Record Numbers Blinding and masking:Participant Blinded | N/A | India→ | Dr J JEYA VENKATESH→ | | 27, Jaihindpuram First street,
Madurai 625011
Tamilnadu
India Kunnanampatti Village,
Karadikkal Post,
Thirumangalam Taluk
Madurai 625706
jeyavenkateshdrs@gmail.com
www.herbalsiddha.com→ | jeyavenkateshdrs@gmail.com→ | | KOKILA SIDDHA HOSPITAL AND RESEARCH CENTRE→ | Inclusion criteria: All COVID-19 positive patients admitted in quarantine and isolation wards, Healthy volunteers coming to Kokila Siddha Hospitals and Research Centre OPD without the history and symptoms of COVID or COVID -19 negative patients,→ | Exclusion criteria: Female patients on menstrual days during the study, Urinary catheter insitu, ventilator and other life support fixed patients, childres below 3 years and elders above 70, women patients with DUB, patients not willing to test their urine→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: COVID 19 POSITIVE CASES ADMITTED IN COVID 19 WARDS: KNOWN POSITIVE UNDER STANDARD CARE<br>Control Intervention1: HEALTHY PERSONS: HEALTHY PERSONS WITH KNOWN HISTORY OF NON COVID-19 INFECTION PAST AND PRESENT VISITED TO KOKILA SIDDHA HOSPITAL RESEARCH CENTRE OPD DURING STUDY. THIS IS A PLACEBO CONTROLLED OBSERVATIONAL TRIAL. ONE ARM HAS COVID POSITIVE CASES AND ANOTHER ARM HAS NON COVID PATIENTS. THE TWO DIFFERENT SUBSETS OF PARTICIPANTS COVID 19 POSITIVE AND COVID 19 NEGATIVE ARE TAKEN AND URINE ANALYIS IS DONE BY AN OBSERVATIONAL STUDY<br>→ | Change of urine pattern and physical property of urine in each stage <br/ ><br>Change of urine pattern and physical property after COVID 19 negativeTimepoint: 3 DAYS→ | | | | Yes | False | | |
| → | CTRI/2021/06/034114 | 7 September 2021 | Ayurveda Intervention in moderate and severe Covid-19 | A study of Gorochanadi Vati as an add on efficacy in moderate and severe Covid - 19 Positive subjects with reduced oxygen saturation - Covid-19 | | Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital Hassan | 09-06-2021 | 20210609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56772 | Not Recruiting | No | | | | 15-06-2021 | 60 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | Dr Suhas Kumar Shetty→ | |
B M Road Thannirhalla Hassan Dr Suhas Kumar Shetty
B M Road Thannirhalla→ | profpnrao@gmail.com→ | 09448064277→ | Sri Dharmasthala Manjunatheshwara College of Ayurveda and Hospital→ | Inclusion criteria: 1. Typical or atypical clinical presentation of acute onset febrile illness with sore throat and dry cough with or without shortness of breath and a RT_PCR based laboratory confirmation test for COVID-19 <br/ ><br>2. Patients with either gender, 21 to 70 years age <br/ ><br>3. Patients with moderate and severe Covid â?? 19 disease with SPO2 less than 94% <br/ ><br>4. Patients willing to participate and sign an informed consent Understands and agrees to comply with planned study procedures. <br/ ><br>→ | Exclusion criteria: 1. Patients suffering from COVID-19 Disease with SpO2 level below 80% as judged by a physician <br/ ><br>2. Severe, Unstable, Uncontrolled co-existent medical illness such as Diabetes, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study <br/ ><br>3. Active cancer diagnosis, on palliative treatment or requiring current therapy with antimetabolic agents, immunotherapy or radiotherapy. <br/ ><br>4. Patients on complete parenteral nutrition <br/ ><br>5. Patients who are likely to worsen or ventilator support due to any reason <br/ ><br>6. Pregnancy and lactation <br/ ><br>7. Physician decision that involvement in the study is not in the patient´s best interest <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J09- Influenza due to certain identified influenza viruses
→ | Intervention1: Standard Care for moderate and severe Covid-19 subjects plus Tab Gorochanadi Vati 125 mg, 3 tab 3 times a day after food for 3 days: Standard Care for moderate and severe Covid-19 subjects plus Tab Gorochanadi Vati 125 mg, 3 tab 3 times a day after food for 3 days<br>Control Intervention1: Standard care for moderate and severe Covid-19 patients for 3 days: Standard care for moderate and severe Covid-19 patients as per ICMR guidelines for 3 days<br>→ | Clinical symptoms and SpO2 saturation and oxygen requirementTimepoint: Baseline, Day 1, Day 2, Bay 3→ | | | | Yes | False | | |
| → | CTRI/2021/06/034115 | 7 September 2021 | Low Dose Whole Lung Radiation Therapy for COVID-19 Pneumonia | Single Institutional Pilot Study Of Low Dose Whole Lung Radiation Therapy In Moderate To Severe COVID-19 Pneumonia Patients. | | Not yet applied | 09-06-2021 | 20210609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56727 | Not Recruiting | No | | | | 17-06-2021 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 1/ Phase 2 | India→ | Poornachandra Tejaswi→ | | Department of Radiation Oncology, Institutional Research Division, Room NO-7, Karnataka Cancer Therapy And Research Institute, Navanagar, Hubballi-Dharwad. → | pct.teju@gmail.com→ | 8105137717→ | Karnataka Cancer Therapy And Research Institute→ | Inclusion criteria: 1. Patient with informed consent <br/ ><br>2. Age >18 yrs and <90 yrs <br/ ><br>3. COVID-19 RT-PCR positive <br/ ><br>4. RT-PCR done less than 7days <br/ ><br>5. Moderate to severe case (NEWS 2 score- more than or equal to 5) <br/ ><br>6. SPO2- <90%, RR- >24 per minute in Room air <br/ ><br>7. KPS >60 <br/ ><br>8. HRCT suggestive of Interstitial pneumonia with CORADS 4-6 and CT severity score of moderate to severe. <br/ ><br>9. Patient able to lie supine for Radiation therapy <br/ ><br>→ | Exclusion criteria: 1. Patient on mechanical ventilator support <br/ ><br>2. Hemodynamically unstable patient <br/ ><br>3. Pregnancy and lactating mothers <br/ ><br>4. Known prior systemic use of the following drugs: Bleomycin, Carmustine, Methotrexate, Busulfan,Cyclophosphamide, or Amiodarone <br/ ><br>5. History of lung lobectomy or pneumonectomy. <br/ ><br>6. History of receiving immunotherapy within the past 6 months. <br/ ><br>7. History of Chronic obstructive pulmonary disease, Severe Left Ventricular Dysfunction and patients on beta blockers. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Low Dose Whole Lung Radiation Therapy: Low Dose Whole Lung Radiation Thearapy, Dose 60cGy in 1Fraction.<br>Control Intervention1: NIL: NIL<br>→ | To evaluate the effect of Low dose radiation therapy (LDRT) on oxygen dependence in moderate to severe COVID 19 pneumonia with National Early Warning Score(NEWS-2).Timepoint: National Early Warning Score(NEWS-2) on Day 3, Day 7 and Day 14 compared with baseline(Day 0).→ | | | | Yes | False | | |
| → | CTRI/2021/06/034116 | 7 September 2021 | Chronic pain management during COVID 19 Pandemic | An analysis of pain management of patients with chronic pain amid COVID 19 pandemic: a cross-sectional observational trial | | Government Medical College and hospital | 09-06-2021 | 20210609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56779 | Not Recruiting | No | | | | 21-06-2021 | 400 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Vanita Ahuja→ | | Room number 521
D block, level 5
Anaesthesia and Intensive care
Government Medical College and Hospital
Sector 32 → | vanitaanupam@yahoo.co.in→ | 9646121649→ | Government Medical College and Hospital→ | Inclusion criteria: Patients who were earlier visiting but now not visiting GMCH during pandemic for chronic pain management <br/ ><br>Non cancer chronic pain more than three months <br/ ><br>→ | Exclusion criteria: Not willing to participate in online survey→ | Health Condition 1: Z538- Procedure and treatment not carried out for other reasons
→ | | To evaluate pain scores of patients with chronic pain amid COVID 19 pandemicTimepoint: At one point time only i.e. when the patients will be filling online questionnaire→ | | | | Yes | False | | |
| → | CTRI/2021/06/034117 | 7 September 2021 | Clinical Progress of Covid 19 disease in Pregnancy | A retrospective longitudinal case control Study to evaluate progression of Covid 19 disease in pregnancy | | Kaliga Institute of Medical Sciences | 09-06-2021 | 20210609 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56828 | Not Recruiting | No | | | | 21-06-2021 | 1500 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sudhanshu Kumar Rath→ | | Dept of Obs Gyn
KIMS KIIT University
Bhubaneswar → | sudhanshu.rath@kims.ac.in→ | 9168479686→ | Kalinga Institute of Medical Sciences→ | Inclusion criteria: All female patient admitted to Odisha KIMS Covid Hospital from March 2020 to May 2021 <br/ ><br> <br/ ><br>→ | Exclusion criteria: Any preexisting medical disorder like diabetes, hypertension, heart disease or respiratory disease→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Change of disease status mild /moderate /severe. <br/ ><br>Oxygen supplementation <br/ ><br>ICU Admission <br/ ><br>Puerperal Sepsis <br/ ><br>surgical site InfectionTimepoint: At Base Line,3 days,7 days and 10 days→ | | | | Yes | False | | |
| → | CTRI/2021/06/034130 | 7 September 2021 | A Phase III Clinical Trial to understand the efficacy and safety of Molnupiravir 800mg in the treatment of patients diagnosed with mild COVID-19 | A Multi-Centric,Prospective, open label , Randomized, Parallel-group, Comparative, Phase III Clinical Trial to evaluate the efficacy and safety of Molnupiravir 800mg in the treatment of patients diagnosed with mild COVID-19 | | BDR Pharmaceuticals Internationals Pvt Ltd | 10-06-2021 | 20210610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56281 | Recruiting | No | | | | 15-06-2021 | 1218 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 3 | India→ | Mukesh Kumar→ | | Department of Clinical operations A-19,1st Floor,Street No.-3, Gurunanak Pura, Laxmi nagar New Delhi,India → | mukesh@rahelife.com→ | 9873038019→ | RAHE LIFE SCIENCE→ | Inclusion criteria: 1.Male or non-pregnant female adult â?¥ 18 years and â?¤ 60 Years of age at time of enrolment. <br/ ><br>2.Patients diagnosed with mild COVID-19 (quarantine ward/home isolation). <br/ ><br>3.Had initial onset of signs/symptoms attributable to COVID-19 for â?¤5 days prior to the day of randomization and at least 1 of the following sign/symptoms attributable to COVID-19 on the day of randomization. <br/ ><br>uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache without any evidence of breathlessness <br/ ><br>4.Patients with confirmed RT PCR positive reports <br/ ><br>5.Female participants of childbearing potential must meet the following criteria to be enrolled: <br/ ><br>i.Have a negative pregnancy test prior to randomization. <br/ ><br>ii.Must agree to undergo a follow-up pregnancy test on study day 28. <br/ ><br>Note that female not of childbearing potential is defined as either:Surgically sterile: Females who are permanently sterile via hysterectomy, bilateral salpingectomy, and/or bilateral oophorectomy by reported medical history and/or medical records. Surgical sterilization to have occurred a minimum of 6 weeks, or at â?¢ For female subjects: evidence of post-menopause, or for pre- menopause subjects, negative pre-treatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his /her partner during the study period and for at least 28 days following the last study treatment <br/ ><br>6.Male participants with female partners must have either Surgical sterilization (vasectomy â?¥1 month before screening) OR <br/ ><br>Female partner must be of not be of childbearing potential OR <br/ ><br>Agree to take effective contraceptive measures (barrier methods or abstinence) with his /her partner during the study period and for at least 28 days following the last study treatment <br/ ><br>7.Subjects who are ready to provide written informed consent and who are <br/ ><br>ready to willingly participate and follow the IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures <br/ ><br> <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1.Subjects who are not able to or not willing to sign an IRB/IEC approved consent form or refusal to participate by legally authorized representative, if present. <br/ ><br>2.Hospitalization or need for immediate medical attention in the clinical opinion of the study investigator. <br/ ><br>3.Haemoglobin <10 g/dL in men and <9 g/dL in women. <br/ ><br> <br/ ><br>4.Platelet count <125,000/L. <br/ ><br> <br/ ><br>5.Estimated Glomerular Filtration Rate (eGFR) <60 mL/min/1.73m2 <br/ ><br> <br/ ><br>6.Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) elevated over 5 times the ULN. <br/ ><br>7.Patient is Pregnant or lactating women <br/ ><br> <br/ ><br>8.Recipient of SARS-CoV-2 vaccine. <br/ ><br> <br/ ><br>9.Known allergy/sensitivity or any hypersensitivity to components of test drug, or its formulation. <br/ ><br> <br/ ><br>10.Use of therapeutic interventions with possible anti-SARS-CoV-2 activity within 30 days prior to study entry, e.g., remdesivir, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine, hydroxychloroquine, convalescent plasma, or participation in a clinical trial involving any of these drugs whether for treatment or prophylaxis. <br/ ><br>11.Patients currently taking nucleos(t)ide analogues/ immunosuppressive treatments within 30 days of study enrolment or systemic corticosteroids. <br/ ><br>12.Presence of a condition, that in the opinion of the investigator, would place the subject at increased risk from study participation. <br/ ><br>13.Patients having chronic bronchitis and/or emphysema, psychiatric, musculoskeletal, or cardiovascular diseases. <br/ ><br>14.Patients suffering from concurrent systemic diseases, with cardiopulmonary tuberculosis, pulmonary eosinophilia, bronchiectasis, cancer, congestive heart failure, hepatic dysfunction, and neurological disorders. <br/ ><br>15.Patients with severe disease, defined as pneumonia plus one of the following: respiratory rate â?¥30 per minute, breathlessness, SpO2 â?¤ 92 on room air. <br/ ><br>16.Use of systemic corticosteroid therapy (this may affect peripheral muscle function). <br/ ><br>17.Subjects who are known cases of immune-compromised or autoimmune condition such as HIV, Hepatitis. <br/ ><br>18.ICU Patient and having severe COVID19 symptoms, known chronic kidney disease stage 4 or 5 or receiving dialysis. <br/ ><br>19.Inability to take or tolerate oral medications.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Molnupiravir: 2 capsules of 200mg each will be given twice a day at interval of 12 hours<br>Control Intervention1: Standard of Care: Ivermectin, symptomatic medication including oral hydration, anti-pyretic,<br>anti-tussive and multivitamins, Empiric antimicrobials<br><br>→ | To evaluate the efficacy of Molnupiravir compared to standard of care in confirmed RT-PCR positive patients with mild COVID-19Timepoint: Rate of hospitalization from randomization up to Day 14→ | | | | Yes | False | | |
| → | CTRI/2021/06/034131 | 7 September 2021 | Clinical trial of ShatPlus Advance in COVID 19 disease | A Double blind, randomized, placebo controlled clinical trial to evaluate safety and efficacy of ShatPlus Advance in mild to moderate patients with COVID 19 disease. - Nil | | BVG Life Sciences Ltd BVG Group | 10-06-2021 | 20210610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56367 | Recruiting | No | | | | 18-06-2021 | 60 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Double Blind Double Dummy | Phase 2 | India→ | Dr Pawan Kumar Singh→ | | Sagar Complex Opposite Kasarwadi Railway Station Old Pune-Mumbai Road Chinchwad Pune - 411034,
Pune 411034
→ | pawan.singh@bvglife.com→ | 9409616256→ | BVG Life Sciences Ltd→ | Inclusion criteria: 1.Age :18- 60 years (Both sex) <br/ ><br>2.Confirmed COVID 19 diseases patient with positive RT-PCR <br/ ><br>3.Mild to moderate disease (NEWS score <7) with or without comorbidity <br/ ><br>4.Patients willing to provide consent and follow up for study duration <br/ ><br>→ | Exclusion criteria: 1.Patients with compromised immunity, autoimmune disease or self-reports HIV or syphilis infection <br/ ><br>2.Proves to be unfit for the study as per the investigatorâ??s discretion <br/ ><br>3.Pregnant or lactating women <br/ ><br>4.Requiring supplemental oxygen and ICU admission at screening <br/ ><br>5.Known case of comorbidity which is uncontrolled and which in investigator discretion finds patients not suitable for the trial participation <br/ ><br>6.Any other medical condition like History of MI, Epileptic episodes finding patients not fit for trial participation <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ShatPlus Advance along with standard treatment: 10 ml thrice a day ShatPlus Advance orally<br>along with standard treatment for 10 days<br>Control Intervention1: Placebo treatment along with standard treatment: 10 ml thrice a day Placebo orally along with standard treatment for 10 days<br>→ | 1.Percent population with negative RT PCR on <br/ ><br>day 4, 7 and 10. <br/ ><br>2.Improvement of clinical symptoms- cough, <br/ ><br>breathlessness, fatigue, myalgia, headache, <br/ ><br>abdominal discomfort, persistent chest pain <br/ ><br>3.Daily SpO2 levels <br/ ><br>4.Requirements of supplemental oxygen <br/ ><br>5.Reduction in elevated levels of inflammatory <br/ ><br>markers such as CRP, LDH, Ferritin, D-dimer <br/ ><br>and Interleukin 6 <br/ ><br>6.Changes in levels of Covid specific IgG <br/ ><br>antibodiesTimepoint: From baseline to end of study ie 10 days <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/06/034132 | 7 September 2021 | Clinical trial of ShatPlus in SARS-CoV-2 Infection. | A Double blind, randomized, placebo controlled clinical trial to evaluate safety and efficacy of ShatPlus as an intervention in subjects with SARS-CoV-2 Infection. - Nil | | BVG Life Sciences Ltd BVG Group | 10-06-2021 | 20210610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56377 | Recruiting | No | | | | 18-06-2021 | 40 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Double Blind Double Dummy | Phase 2 | India→ | Dr Pawan Kumar Singh→ | | Sagar Complex, Opposite Kasarwadi Railway Station, Old Pune-Mumbai Road,Chinchwad, Pune - 411034,
India
Pune
MAHARASHTRA
411034
India → | pawan.singh@bvglife.com→ | 9409616256→ | BVG Life Sciences Ltd.→ | Inclusion criteria: 1.Age :18- 60 years (Both sex) <br/ ><br>2.Confirmed COVID 19 Subject with positive RT-PCR <br/ ><br>3.Mild to moderate disease (NEWS score <7) with or without comorbidity <br/ ><br>4.Subject willing to provide consent and follow up for study duration <br/ ><br>→ | Exclusion criteria: 1.Subjects with compromised immunity, autoimmune disease or self-reports HIV or syphilis infection <br/ ><br>2.Proves to be unfit for the study as per the investigatorâ??s discretion <br/ ><br>3.Pregnant or lactating women <br/ ><br>4.Requiring supplemental oxygen and ICU admission at screening <br/ ><br>5.Known case of comorbidity which is uncontrolled and which in investigator discretion finds subject not suitable for the trial participation <br/ ><br>6.Any other medical condition like History of MI, Epileptic episodes finding subject not fit for trial participation <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ShatPlus along with standard<br>treatment<br>: 10 ml thrice a day ShatPlus orally along with standard treatment for 10 days<br>Control Intervention1: Placebo along with standard<br>treatment<br>: 10 ml thrice a day placebo orally along with standard treatment for 10 days<br>→ | 1.Percent population with negative RT PCR on day 4, 7 and 10. <br/ ><br>2.Improvement of clinical symptoms- cough, breathlessness, fatigue, myalgia, headache, abdominal discomfort, persistent chest pain <br/ ><br>3.Daily SpO2 levels <br/ ><br>4.Requirements of supplemental oxygen <br/ ><br>5.Reduction in elevated levels of inflammatory markers such as CRP, LDH, Ferritin, D-dimer and Interleukin 6 <br/ ><br>6.Changes in levels of Covid specific IgG antibodiesTimepoint: From baseline to end of study ie 10 days→ | | | | Yes | False | | |
| → | CTRI/2021/06/034144 | 7 September 2021 | Immediate effect of steam inhalation on Oxygen Saturation - A Randomized Controlled Clinical Trial | Effect of Steam Inhalation on oxygen saturation in patients with Covid-19 - A Randomized Controlled Clinical Trial | | Government Yoga and Naturopathy Medical College and Hospital | 10-06-2021 | 20210610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56428 | Not Recruiting | No | | | | 16-06-2021 | 75 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Prof Dr Manavalan Narayanaswamy→ | | Government Yoga and Naturopathy Medical College and Hospital
Department of Naturopathy
Arignar Anna Indian Medicine Campus
Arumbakkam
Chennai → | gynmcchennai@gmail.com→ | 7010436261→ | Government Yoga and Naturopathy Medical College and Hospital→ | Inclusion criteria: 1. Patients with COVID-19 with moderate or severe category with oxygen saturation â?¥70% <br/ ><br>2. Willing to participate→ | Exclusion criteria: 1) Patients with severe COVID 19 infection & oxygen saturation <70% <br/ ><br>2) Patient unable to consent <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Steam inhalation for 15 minutes: The steam will be generated through a standing type steam generator and the steam nozzle will be kept at a distance of 15-30 cms from the patient. The patient will be made to sit in upright position and asked to take deep inhalations of steams through nose and mouth. The patient will be asked to inhale steam for a maximum of 15 minutes and the duration, they take the steam will be recorded. <br>The study is an immediate effect study and total duration of intervention will be only 15 minutes<br>Intervention2: Steam inhalation for 15 minutes followed by 30 seconds of cold compress: The steam will be generated through a standing type steam generator and the steam nozzle will be kept at a distance of 15-30 cms from the patient. The patient will be made to sit in upright position and asked to take deep inhalations of steams through nose and mouth. The patient will be asked to inhale steam for a maximum of 15 minutes and the duration, they take the steam will be recorded.<br>At the end of steam, a cold compress will be applied on the face for 30 seconds.<br>The study is an immediate effect study and total duration of intervention will be only 15 minutes<br>Control Intervention1: Rest in supine/slanting position: The patient in the control group will be asked to rest for 15 minutes. Patients will be asked to do normal breathing.<br>→ | Oxygen saturation (Spo2)Timepoint: During intervention <br/ ><br>At 5 minutes <br/ ><br>At 10 minutes <br/ ><br>After intervention <br/ ><br>At 15 minutes <br/ ><br>Post effects <br/ ><br>At 25 minutes <br/ ><br>At 35 minutes <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/06/034145 | 7 September 2021 | Siddha Covid-19 Treatment | Documentation, Clinical Validation, Safety Assessment and Efficacy of Siddha treatment in COVID-19/SARS-CoV-2: A case series | | Kokila Siddha Hospital and Research Centre | 10-06-2021 | 20210610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56859 | Recruiting | No | | | | 18-06-2021 | 20 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | N/A | India→ | Mr S Senthilnathan→ | | Kokila Siddha Hospital and Research Centre,
27, jaihindpuram I Street,
Madurai 625011 Kokila Siddha Hospital and Research Centre,
Kunnanampatti Village
Karadikkal,
Thirumangalam,
Madurai 625706→ | jeyavenkateshdrs@gmail.com→ | 9842167567→ | Kokila Siddha Hospital and Research Centre→ | Inclusion criteria: All asymptomatic, symptomatic, mild and mild to moderate patients either rtpcr positive or ct chest covid viral pneumonia confirmed or both→ | Exclusion criteria: Moderate and severe covid 19 cases <br/ ><br>Transgender <br/ ><br>Spo2 below 80 <br/ ><br>Bp below 80/60 <br/ ><br>Bp above 160/100 <br/ ><br>Rr above 40 <br/ ><br>Pregnancy <br/ ><br>Lactation <br/ ><br>IDDM <br/ ><br>Known cardiac patients <br/ ><br>Underwent capg <br/ ><br>Mucormycosis→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | Increase or maintenance of spo2 <br/ ><br>Normalizing of respiratory rate <br/ ><br>Normalizing of temperature <br/ ><br>Normalizing of taste <br/ ><br>Easy breathing <br/ ><br>Timepoint: 5th Day→ | | | | Yes | False | | |
| → | CTRI/2021/06/034149 | 7 September 2021 | COVID-19 Siddha Treatment | Documentation, validation and exploring the efficacy of Envagai Thervu (Eight Diagnostic Methods) COVID 19 cases â?? Observational study | | Dr J Jeyavenkatesh | 10-06-2021 | 20210610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56860 | Recruiting | No | | | | 18-06-2021 | 20 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | N/A | India→ | Mr S Senthilnathan→ | | Kokila Siddha Hospital and Research Centre,
27, Jaihindpuram I Street,
Madurai 625011
Kokila Siddha Hospital and Research Centre
Kunnanampatti Village
Karadikkal Post
Thirumangalam Taluk
Madurai 625706
→ | jeyyavenkateshdrs@gmail.com→ | 914522675674→ | Kokila Siddha Hospital and Research Centre→ | Inclusion criteria: All Covid Positve Patients Either RTPCR Positive Or CT Chest Confirmed Or Both.→ | Exclusion criteria: Pregnancy <br/ ><br>Lactation <br/ ><br>Spo2 Below 80 <br/ ><br>RR Above 40 <br/ ><br>PR Above 60 But Below 120 <br/ ><br>Non-Urinary Catheterized <br/ ><br>Transgender <br/ ><br>Known Cardiac Patients <br/ ><br>IDDM <br/ ><br>Hba1c Above 10 <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nil: Nil<br>→ | Observation of Tongue, Colour, Speech, Eyes, Skin, Stools, Urine and Pulse DiagnosisTimepoint: 3 and 5th day→ | | | | Yes | False | | |
| → | CTRI/2021/06/034162 | 7 September 2021 | Evaluation of use and right time identification to initiate Tofacitinib use in the treatment of moderate- severe COVID-19 infection | TOF-RI-TIME: Evaluating efficacy and identifying the right time to initiate Tofacitinib use in the treatment protocol for Moderate - Severe COVID 19 infection : a 2 arm, open label randomised, controlled trial | | St Johns Medical College Hospital | 10-06-2021 | 20210610 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56057 | Not Recruiting | No | | | | 20-06-2021 | 409 | Interventional | Other<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Deepak Kamath→ | | St Johns Medical College Hospital Hosur Road Bangalore 560034 → | vineeta.s@stjohns.in→ | 9845021146→ | St Johns Medical College Hospital→ | Inclusion criteria: 1. Signs and symptoms consistent with COVID-19 <br/ ><br>infection confirmed with rapid antigen test (RAT) <br/ ><br>or RT- PCR. <br/ ><br>2. Hospitalised with moderate or severe COVID-19 <br/ ><br>illness→ | Exclusion criteria: 1. COVID-19 like illness, not confirmed by RAT/ RTPCR. <br/ ><br>2. Prior treatment with any of Jakinibs for any <br/ ><br>indication. <br/ ><br>3. Past treatment with any of the following biologics - <br/ ><br>TNF(i), tocilizumab(in the last 3 months). <br/ ><br>4. e-GFR < 30 ml/hr at screening. <br/ ><br>5. Pre-existing lung disease requiring home oxygen <br/ ><br>therapy. <br/ ><br>6. Malignancies on conventional chemotherapeutic <br/ ><br>regimens or targeted treatments. <br/ ><br>7. Post- transplant with ongoing immunosuppressive <br/ ><br>therapy, <br/ ><br>8. HIV/AIDS <br/ ><br>9. Pregnancy <br/ ><br>10. Critically ill patients in ICU <br/ ><br>11. Coexisting septic shock, and/or multiple organ <br/ ><br>dysfunction <br/ ><br>12. Anticipated death within next 24 hours as per→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tablet Tofacitinib 10 mg BID: Tablet Tofacitinib 10 mg BID on top of Standard Care for 10 days. <br> Comparator is Standard Care alone, no placebo Intervention â?? Tablet. Tofacitinib 10 mg BD for 10 days (over currently recommended standard of care as per AIIMS and Government of Karnatakaâ??s protocol); <br>Control â?? Current standard of care as per AIIMS and Government of Karnatakaâ??s protocol. <br><br>Control Intervention1: Not Applicable: Not Applicable<br>→ | All-cause mortality up to 28 days of follow-up in the intervention versus control <br/ ><br>group.Timepoint: 28 days from randomization→ | | | | Yes | False | | |
| → | CTRI/2021/06/034167 | 7 September 2021 | High flow nasal oxygenation as assiteds device for intubation in COVID Patients | Role of high flow nasal oxygenation during video Laryngoscopy assisted intubation in COVID-positive patients: A randomized control trial | | Institute of medical sciences | 11-06-2021 | 20210611 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49227 | Not Recruiting | No | | | | 15-06-2021 | 30 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Investigator Blinded | N/A | India→ | dr rajesh kumar meena→ | | DEPARTMENT OF ANESTHESIA IMS BHU department of anesthesia ims BHU→ | drrajaiims86@gmail.com→ | 9643975465→ | Institute Of Medical Sciences→ | Inclusion criteria: 1. Patients requiring intubation in ICU <br/ ><br>2. Sex M/F <br/ ><br>3. Age: 18years or older <br/ ><br>4. Weight: 40-100 kg <br/ ><br>→ | Exclusion criteria: 1. Intubation without RSI(in case of cardiac arrest) <br/ ><br>2. Asphyxia requiring immediate intubation <br/ ><br>3. Any nasopharyngeal anatomical obstacle <br/ ><br>4. Grade 4 glottis exposure on the Cormackâ??Lehane scale documented in the medical history <br/ ><br>5. pregnancy <br/ ><br>6. Lack of consent <br/ ><br>7. patients who had already undergone intubation in the ICU (i.e., extubation failure) or who were already participating in an interventional study on pre-oxygenation <br/ ><br>→ | Health Condition 1: J069- Acute upper respiratory infection,unspecified
→ | Intervention1: HFNC: APPLYING HFNC FOR PREOXYGENATION<br>Control Intervention1: STANDARD MASK OXYGENATION: STANDARD MASK OXYGENATION AS PREOXYGENATION<br>→ | median lowest sp02 during intubationTimepoint: baseline, 1 Mins, 2 Mins→ | | | | Yes | False | | |
| → | CTRI/2021/06/034182 | 7 September 2021 | Does raising the head of the bed improve ventilation in COVID-19 patients on ventilators? | Effect of head of bed elevation on respiratory mechanics in mechanically ventilated COVID-19 patients. | | Postgraduate Institute of Medical Education and Research | 11-06-2021 | 20210611 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55948 | Not Recruiting | No | | | | 15-06-2021 | 20 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ananya Ray→ | | Department of Anaesthesia,
Postgraduate Institute of Medical Education and Research → | ananyaray1812@hotmail.com→ | 7087009532→ | Postgraduate Institute of Medical Education and Research→ | Inclusion criteria: Adults with ARDS (by Berlin criteria) <br/ ><br>Intubated and on mechanical ventilation <br/ ><br>COVID-19 positive <br/ ><br>Hemodynamically stable (nil or low-dose inotropes) <br/ ><br>→ | Exclusion criteria: â?¢ Clinical evidence of secondary lower respiratory tract infection <br/ ><br>â?¢ Pre-existing pulmonary disease or pulmonary surgery <br/ ><br>â?¢ Rib fractures <br/ ><br>â?¢ Connective tissue diseases <br/ ><br>â?¢ Kyphosis/scoliosis <br/ ><br>â?¢ High intra-abdominal pressure <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Head of bed elevation: The head-end of the bed will be elevated by 10, 20, 30 degrees for 2 minutes each. A goniometer will be used for accuracy of degree.<br>Control Intervention1: Supine posture.: Values will be measured in 0 degrees supine posture maintained for 2 minutes.<br>→ | To assess the respiratory mechanics with different degrees of Trendelenburg and reverse Trendelenburg positions in patients with COVID ARDS.Timepoint: 1 minute after intervention.→ | | | | Yes | False | | |
| → | CTRI/2021/06/034183 | 7 September 2021 | To determine whether the change in blood pressure during head down position and transiently increasing breath volume can predict the response to fluid therapy in seriously ill patients on mechanical ventilator receiving low breath volume and in prone position during COVID pandemic | To determine whether the change in pulse pressure variation during Trendelenburg manoeuvre and â??Tidal volume challengeâ?? can predict fluid responsiveness in critically ill patients ventilated using low tidal volume and in prone position during COVID pandemic | | Natesh Prabu R | 11-06-2021 | 20210611 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56756 | Not Recruiting | No | | | | 14-06-2021 | 40 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Natesh Prabu R→ | | Department of Critical Care Medicine,
New Silver jubilee block,
St Johns Medical College Hospital,
Sarjapura road → | drnateshrprabu@gmail.com→ | 08022065334→ | St Johns Medical college hospital→ | Inclusion criteria: Adult patients (Age > 18 yrs ) <br/ ><br>Acute circulatory failure <br/ ><br>Receiving protective lung ventilation â?¤ 6ml/kg IBW using Volume Assist Control mode, without any spontaneous activity <br/ ><br>Need of prone ventilation as decided by treating physician. <br/ ><br>→ | Exclusion criteria: Cardiac arrhythmias, Acute myocardial infarction <br/ ><br>Previously known significant valvular disease or intracardiac shunt <br/ ><br>Air leakage through chest drains <br/ ><br>Right heart failure <br/ ><br>An urgently required fluid challenge. <br/ ><br>Abdominal compartment syndrome, and pregnancy <br/ ><br>Raised intracranial hypertension <br/ ><br>→ | Health Condition 1: J80- Acute respiratory distress syndrome
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: I959- Hypotension, unspecified
Health Condition 4: R098- Other specified symptoms and signsinvolving the circulatory and respiratory systems
Health Condition 5: J189- Pneumonia, unspecified organism
Health Condition 6: J969- Respiratory failure, unspecified
→ | Intervention1: Trendelenburg test and tidal volume challenge test: The trendelenburg test is performed by moving the bed from 15 degree up position to near 15 degree down position. The change in pulse pressure variation is noted<br>The tidal volume is increased from 6mL/kg Predicted body weight to 8mL/kg PBW and the change in pulse pressure variation is noted<br>Control Intervention1: Nil<br>: The groups will be divided as fluid responders and fluid non responders. The change in pulse pressure variation after trendelenburg test and tidal volume test is compared.<br>→ | To determine whether the change in Pulse Pressure Variation during Trendelenburg manoeuvre in prone ventilation and â??tidal volume challengeâ?? can reliably predict fluid responsiveness in patients ventilated in prone position.Timepoint: baseline→ | | | | Yes | False | | |
| → | CTRI/2021/06/034190 | 7 September 2021 | Blood tests to predict severity of Covid | The role of NLR and other circulating biomarkers in predicting the prognosis of COVID-19 | | Dr Surag MK | 11-06-2021 | 20210611 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56969 | Not Recruiting | No | | | | 27-06-2021 | 200 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Surag MK→ | | Department of General Medicine
Government Medical College,Kannur
Pariyaram → | suragsreedhar@gmail.com→ | 9400480660→ | Government Medical College,Kannur,Pariyaram→ | Inclusion criteria: RT-pcr positive Covid19 cases are included in the study→ | Exclusion criteria: Covid positive patients with a primary diagnosis other than Covid pneumonia→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | deathTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/06/034208 | 7 September 2021 | Adverse effects of COVID VACCINES | â??Assessment and correlation of adverse drug reactions following COVID vaccination with blood group and dietary style -A pilot study.â?? | | YENEPOYA MEDICAL COLLEGE | 14-06-2021 | 20210614 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54815 | Not Recruiting | No | | | | 15-06-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr PRABHAKAR ADAKE→ | | Yenepoya Medical College, Deralakatte
MANGALORE-575018 Associate Professor of Pharmacology
Yenepoya Medical College, Deralakatte
MANGALORE-575018→ | dradake82@gmail.com→ | 09886554800→ | YENEPOYA MEDICAL COLLEGE→ | Inclusion criteria: Medical/dental/Allied health undergraduates & postgraduate student and health care professionals of Various colleges affiliated to Yenepoya (Deemed to be University), Mangalore who are vaccinated and willing to give their consent for this study will be included.→ | Exclusion criteria: Individuals who are not vaccinated and do not give consent for the study→ | | Control Intervention1: NIL: NIL<br>→ | different types of adverse drug reactions following COVID vaccination and to correlate with blood groups and dietary styleTimepoint: DAY1 TO DAY 4→ | | | | Yes | False | | |
| → | CTRI/2021/06/034220 | 7 September 2021 | A Phase II/III Clinical Trial to understand the efficacy and safety of Molnupiravir 800mg in the treatment of patients diagnosed with moderate COVID-19 | A Multi-Centric,Prospective, open label, Randomized, Parallel-group, Comparative, Phase II/III Clinical Trial to evaluate the efficacy and safety of Molnupiravir 800mg in the treatment of patients diagnosed with moderate COVID-19. | | BDR Pharmaceuticals Internationals PvtLtd | 14-06-2021 | 20210614 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56466 | Recruiting | No | | | | 15-06-2021 | 1282 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Mukesh Kumar→ | | Department of Clinical operations A-19,1st Floor,Street No.-3, Gurunanak Pura, Laxmi nagar New Delhi,India → | mukesh@rahelife.com→ | 9873038019→ | RAHE LIFE SCIENCE→ | Inclusion criteria: 1.Male or female patients between 18 and 60 years of age (both inclusive). <br/ ><br>2.Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal and/or oropharyngeal swabs (sample collected â?¤5 days prior to randomization) <br/ ><br>3.Patients with moderate COVID-19 and have any one of the following symptoms and signs prior to randomization. <br/ ><br>Respiratory rate â?¥24/min, breathlessness <br/ ><br>SpO2: 90% to â?¤93% on room air <br/ ><br>4.Patients who are able to consume oral medications. <br/ ><br>5.Males agree to the following during the intervention period and for at least 90 days after the last dose of study intervention: <br/ ><br>6.Refrain from donating sperm; and either abstain from sexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception <br/ ><br>7.Females who are not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP and using a contraceptive method that is highly effective (a low user dependency method OR a user dependent method in combination with barrier method), or be abstinent from sexual intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) for 28 days from the start of study intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or serum test is required) within 24 hours before the first dose of study intervention <br/ ><br>8.Female participants of childbearing potential must meet the following criteria to be enrolled:Have a negative pregnancy test prior to randomization. <br/ ><br>9.For female subjects: evidence of post-menopause, or for pre-menopause subjects, negative pre-treatment serum or urine pregnancy test and agree to take effective contraceptive measures (barrier methods or abstinence) with his /her partner during the study period and for at least 28 days following the last study treatment <br/ ><br>10.Male participants with female partners must have either Surgical sterilization (vasectomy â?¥1 month before screening) OR <br/ ><br>11.Female partner must be of not be of childbearing potential OR Agree to take effective contraceptive measures (barrier methods or abstinence) with his <br/ ><br>/her partner during the study period and for at least 28 days following the last study treatment. <br/ ><br>12.Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the IEC/IRB approved Informed Consent Form (ICF) prior to initiation of any study procedures→ | Exclusion criteria: Known hypersensitivity or contraindications to any of the components of the study interventions or to any other similar class of drugs as determined by the investigator. <br/ ><br>Uncontrolled comorbid medical conditions <br/ ><br>Patient is currently admitted to Intensive Care Unit (ICU) and has any one of the following symptoms. <br/ ><br>Respiratory rate >30/min, breathlessness <br/ ><br>SpO2 < 90% on room air <br/ ><br>Patient is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m2 by the Modification of Diet in Renal Disease (MDRD) equation. <br/ ><br>If patient has any of the following conditions: human immunodeficiency virus (HIV); chemotherapy required within 6 weeks before randomization; a neutrophilic granulocyte absolute count <500/mm3; autologous or allogeneic hematopoietic stem cell transplant recipient. <br/ ><br>If patient has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening. <br/ ><br>If patient has a platelet count <100,000/μL or received a platelet transfusion in the 5 days prior to randomization. <br/ ><br>Patient has a history of acute pancreatitis within 3 months prior to randomization or a history of chronic pancreatitis. <br/ ><br>Patient is currently receiving or anticipated to require any prohibited medications/ therapies (e.g. Favipiravir, Oseltamivir, Remdesivir or any other anti-viral treatments) during study participation as per investigatorâ??s discretion. <br/ ><br>A baseline heart rate of < 60 beats per minute at rest <br/ ><br>If patient has any condition for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments including but not limited to: participants who are not expected to survive longer than 48 hours after randomization, participants who are expected to require mechanical ventilation within 48 hours after randomization, or participants with a recent history of mechanical ventilation, or participants with conditions that could <br/ ><br>Limit gastrointestinal absorption based on previous medical records of the <br/ ><br>patient→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Molnupiravir 200mg capsules, (4 x 200mg), twice a day: 2 capsules of 200mg each will be given twice a day at interval of 12 hours<br>Control Intervention1: Standard care of therapy: Oxygen therapy through non-rebreathing face mask<br>Anti-inflammatory or immunomodulatory therapy: Inj. Methylprednisolone<br>0.5 to 1 mg/kg in 2 divided doses (or an equivalent dose of dexamethasone) usually for a duration of 5 to 10 days. Patients may be initiated or switched to oral route if stable and/or improving<br>Anticoagulation: Conventional dose prophylactic unfractionated heparin or Low Molecular Weight Heparin (weight based e.g., enoxaparin 0.5mg/kg per day SC)<br>Symptomatic management (oral hydration, anti-pyretics, antitussive, multivitamins) ,Empiric antimicrobials for co-infections<br><br>→ | to evaluate the efficacy of Molnupiravir 800mg in the treatment of patients diagnosed with moderate COVID- 19.Timepoint: Proportion of patients with clinical improvement at Day 14→ | | | | Yes | False | | |
| → | CTRI/2021/06/034236 | 7 September 2021 | The Study Of Maternal Mortality in Covid 19 Positive Pregnant Women - A Prospective Observational study | The Study Of Maternal Mortality in Covid 19 Positive Pregnant Women - A Prospective Observational study | | ShriBMPatil Medical college | 15-06-2021 | 20210615 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56633 | Not Recruiting | No | | | | 19-06-2021 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Jayasree→ | | Shri.B.M.Patil Medical college,BLDE(DU) University,Bijapur. Shri.B.M.Patil Medical college,BLDE(DU) University,Bijapur.→ | dr.jayasreereddy.j@gmail.com→ | 9642356083→ | | Inclusion criteria: All Covid Positive pregnant women getting admitted to Labour Room at BLDE (DU) Shri BM Patil medical college→ | Exclusion criteria: Patients with pre-existing diabetes mellitus and renal disease are excluded from the study→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: R99- Ill-defined and unknown cause of mortality
→ | | to see the effect of covid 19 second wave in pregnancyTimepoint: At The Baseline Level→ | | | | Yes | False | | |
| → | CTRI/2021/06/034254 | 7 September 2021 | Clinical trial of APMV2020 in Covid 19 subjects | Randomized controlled clinical trial to assess the efficacy and safety of APMV2020 in mild symptomatic subjects of COVID 19 - Nil | | Meyer Organics Pvt Ltd | 15-06-2021 | 20210615 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56647 | Recruiting | No | | | | 15-06-2021 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Mr Taasin Ahmed Shah→ | | A-303, Road No. 32, Wagle Estate, Thane → | tdcruz@meyer.co.in→ | 912225817126→ | Meyer Organics Pvt. Ltd.→ | Inclusion criteria: 1.Age -18- 60 years (Both sex) <br/ ><br>2.Confirmed COVID 19 patient with positive RT-PCR <br/ ><br>3.Mild symptomatic patients having no signs of severe disease (NEWS score â?¤6) <br/ ><br>4.Home/ institutional quarantined subjects with no necessity of dedicated hospital admission at the time of screening <br/ ><br>5.Subject willing to provide consent and follow up for study duration <br/ ><br>→ | Exclusion criteria: 1.Patients with autoimmune disease or self-reports HIV or syphilis infection <br/ ><br>2.Subject suffering from disorders where Aspirin is contraindicated and/or as per the discretion of investigator <br/ ><br>3.Proves to be unfit for the study as per the investigatorâ??s discretion <br/ ><br>4.Pregnant or lactating women <br/ ><br>5.Requiring hospital admission at screening <br/ ><br>6.Any other comorbidity which is critical stage at screening which in investigator discretion finds subject not suitable for the trial participation <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Component A (AP): Tablet containing Aspirin and Promethazine Hydrochloride<br>Component B (MV) Multivitamin and multimineral tablet<br>Along with standard of care as per MoHFW guidelines: Component A and B one tablet each orally twice a day for 10 days<br>Control Intervention1: Standard of care as per MoHFW guidelines: Standard of care as per MoHFW guidelines for 10 days<br>→ | 1.Improvement of clinical symptoms including fever, headache, diarrhea, breathlessness, cough, anosmia, fatigue and myalgia on 10 point VAS scale 0- no symptom and 10-severe symptom. <br/ ><br>2.Reduction in elevated levels of inflammatory markers such as CRP, LDH Ferritin and D-Dimer. <br/ ><br>3.Changes in blood oxygen level SPO2Timepoint: Screening day3 day5 and day10→ | | | | Yes | False | | |
| → | CTRI/2021/06/034255 | 7 September 2021 | ICMR â?? RUMC COVID-19 Sequelae Study among Health Care Workers | ICMR â?? RUMC COVID-19 Sequelae Study among Health Care Workers | | ICMR | 15-06-2021 | 20210615 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53972 | Not Recruiting | No | | | | 01-07-2021 | 557 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Shubham Atal→ | | Department of Pharmacology, AIIMS, Bhopal, M.P. → | shubham.pharm@aiimsbhopal.edu.in→ | | Department of Pharmacology, AIIMS, Bhopal, M.P.→ | Inclusion criteria: All consenting HCWs with laboratory confirmation of COVID-19 infection including asymptomatic cases, working in ICMR RUMC institutions who have recovered (been declared â??dischargedâ??) as per MoHFW guidelines 12 to 52 weeks ago.→ | Exclusion criteria: 1. Any serious co-morbid medical or mental health condition that would make the subject unable to participate in the study. <br/ ><br> <br/ ><br>2. Pregnancy <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. Estimation of prevalence of persistent symptoms in recovered COVID-19 HCWs. <br/ ><br> <br/ ><br>2. Estimation of the associated with the medical sequelae in recovered COVID-19 HCWs.Timepoint: In this study, data collection from HCWs who had recovered (â??dischargedâ??) from COVID-19 12 to 52 weeks ago.→ | | | | Yes | False | | |
| → | CTRI/2021/06/034256 | 7 September 2021 | Clinical trial of nutritional supplement with Covid 19 Vaccine | Clinical validation of effectiveness of Immunace forte and Ultra D3 to improve the Safety Tolerability Immunogenicity of SARS CoV 2 Vaccine Against COVID 19 in Healthy Individuals - Nil | | Meyer Organics Pvt Ltd | 15-06-2021 | 20210615 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56652 | Recruiting | No | | | | 16-06-2021 | 200 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Ms Tania Dcruz→ | | Medical services department, A-303, Road No. 32, Wagle Estate, Thane → | tshah@meyer.co.in→ | | Meyer Organics Pvt. Ltd.→ | Inclusion criteria: 1.Provides written informed consent prior to initiation of any study procedures. <br/ ><br>2.Be able to understand and agrees to comply with planned study procedures and be available for all study visits. <br/ ><br>3.Agrees to the collection of venous blood per protocol. <br/ ><br>4.Male or non-pregnant female, > 18 years of age at time of enrollment. <br/ ><br>5.Body Mass Index (BMI) 18.0-35.0 kg/m2 at screening. <br/ ><br>6.Women of childbearing potential must agree to use acceptable primary form of contraception <br/ ><br>7.In good health and with stable prescription for comorbidities if any.→ | Exclusion criteria: 1.Confirmed pregnancy test either at screening or just prior to each vaccine administration. <br/ ><br>2.Female subject who is breastfeeding. <br/ ><br>3.Has any medical disease or condition that, in the opinion of the participating site principal investigator (PI) or appropriate sub-investigator, precludes study participation. <br/ ><br>4.Presence of self-reported or medically documented significant medical or psychiatric condition(s). <br/ ><br>5.Currently enrolled in or plans to participate in another clinical trial with an investigational agent or receiving similar medication that of investigational product for prophylaxis of COVID-19. <br/ ><br>6.Uncontrolled comorbidity. <br/ ><br>7.Chronic use (more than 14 continuous days) of any medications that may be associated with impaired immune responsiveness. <br/ ><br>8.Received immunoglobulin and/or any blood or blood products within the 4 months before the first vaccine administration or at any time during the study. <br/ ><br>9.Has any significant hematological disorder of coagulation. <br/ ><br>10.Has any chronic liver disease, including fatty liver. <br/ ><br>11.Has a history of alcohol or drugs abuse. <br/ ><br>12.History of documented infection of COVID-19.→ | | Intervention1: Immunace forte & Ultra D3 tablets: Immunace forte one tablet orally after main meal & Ultra D3 tablets one tablet orally after main meal for for 15 to 19 weeks<br>Control Intervention1: Nil: Nil<br>→ | 1.SARS-CoV-2 serum neutralizing antibody levels. <br/ ><br>2.Percentage of subjects turning RT-PCR positive for Covid-19 after vaccinationTimepoint: Baseline within 1 week of first dose of vaccine, At second dose of vaccine ie Weeks 12-16 after First dose of vaccine and 3 weeks after second dose of vaccine→ | | | | Yes | False | | |
| → | CTRI/2021/06/034269 | 7 September 2021 | Presentation of Second Wave of Covid-19 Patients in Vaccinated People | Clinical, Laboratory and Radiological Profile of Second Wave of Covid-19 Patients with Special Reference to Vaccination Status - NA | | KIMS HOSPITAL | 16-06-2021 | 20210616 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56902 | Not Recruiting | No | | | | 21-06-2021 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Debasis Behera→ | | Department of Pulmonary Medicine Kalinga Institute of Medical Science, Bhubaneswar
Beleswar, Nayabazar, Cuttack, 753004→ | drdebasis8@gmail.com→ | 09971852101→ | Kalinga Institute of Medical Science, Bhubaneswar→ | Inclusion criteria: All patients admitted with age > 18 years to COVID hospital, KIMS, Bhubaneswar. <br/ ><br>Written informed consent available. <br/ ><br>→ | Exclusion criteria: Pregnant women <br/ ><br>Presence of end stage lung, renal, hepatic and cardiovascular disease <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. To determine the clinical, laboratory and radiological manifestation of COVID-19 patients affected in second wave. <br/ ><br>2. To compare the clinical presentation, laboratory and radiological manifestations between vaccinated and unvaccinated groups. <br/ ><br>Timepoint: 1-6 months→ | | | | Yes | False | | |
| → | CTRI/2021/06/034284 | 7 September 2021 | A clinical trial study to evaluate the safety and efficacy of low dose radiation therapy for the treatment of Covid-19 disease | A Prospective, Open-Label, Parallel Group Clinical Trial To Evaluate Safety And
Efficacy Of Low Dose Radiation Therapy For Covid-19 Pneumonia: As Add On
To Standard Of Care For Treatment Of Moderate To Severe Patients With Covid-19 Disease. - ECC-LDRT-001 | | DrRSURESHKUMAR MBBSMDRT | 17-06-2021 | 20210617 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56762 | Not Recruiting | No | | | | 01-07-2021 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | DrKVelavan→ | | Erode Cancer Centre Private Limited
Department of Clinical Research,
Ground Floor Room .No: 5,
No:1/393, Velavan Nagar,
Thindal, Erode â?? 638012,
India Erode Cancer Centre Private Limited
Department of Clinical Research,
Ground Floor Room .No: 5,
No:1→ | kvels@rediffmail.com→ | | Erode Cancer Centre Private Limited→ | Inclusion criteria: 1.Male or female with above 45 years of age, at the time of providing informed <br/ ><br>consent. <br/ ><br>2. Agreement to take effective contraception measures (including hormonal <br/ ><br>contraception, barrier methods or abstinence) with his/her partner during the study <br/ ><br>3. Patients with positive RT-PCR test for SARS-CoV-2 in nasopharyngeal or <br/ ><br>oropharyngeal swabs (sample collected â?¤5 days prior to randomization) or CT <br/ ><br>score CORADS III. <br/ ><br>Note: If rapid antigen test has been performed and patient found positive then RT PCR will be performed prior to enrollment. <br/ ><br>4. Has moderate to severe COVID-19 infection as defined as (with any one of the <br/ ><br>following signs) <br/ ><br>a. Respiratory rate â?¥ 24 and Ë?30/min, breathlessness <br/ ><br>b. Oxygen saturation <93% without O2 support or patients requiring > <br/ ><br>4L/Min of O2 <br/ ><br>As defined by AIIMS/ ICMR-COVID-19 National Task Force/Joint Monitoring <br/ ><br>Group (Directorate General of Health Services) Ministry of Health & Family <br/ ><br>Welfare, Government of India- clinical guidance for management of adult <br/ ><br>COVID-19 patients, dated 22nd Apr 2021 <br/ ><br>5. Is willing and able to take Radiation Therapy. <br/ ><br>6. Raised CRP at the time of admission <br/ ><br>7. Symptom onset less than 10 days or fewer. <br/ ><br>8. CT Chest finding suggestive of pneumonic changes. <br/ ><br>9. CT Severity index more than 8/25 (Moderate) <br/ ><br>10. Willingness to comply with study instructions for its duration as indicated by <br/ ><br>written informed consent from the patient/ LAR (in case LAR provides consent <br/ ><br>initially, consent from patient to be obtained again as and when his/ her condition <br/ ><br>stabilizes adequately). <br/ ><br>11. Negative urine pregnancy test prior to beginning the therapy for female patients of <br/ ><br>child-bearing potential only <br/ ><br>→ | Exclusion criteria: 1. Pregnancy or lactation <br/ ><br>2. History of allergy or hypersensitivity to any other treatment component based on <br/ ><br>investigators assessment <br/ ><br>3. Patients on dialysis or having reduced glomerular filtration rate (eGFR) <30 <br/ ><br>mL/min/1.73m2 <br/ ><br>by the Modification of Diet in Renal Disease (MDRD) equation <br/ ><br>4. Tested positive for Human immunodeficiency virus (HIV), Hepatitis B virus <br/ ><br>(HBV) or Hepatitis C virus (HCV) infection <br/ ><br>5. Abnormal laboratory findings at screening <br/ ><br>ï?· Aspartate aminotransferase (AST) >3X upper limit of normal <br/ ><br>ï?· Alanine aminotransferase (ALT) >3X upper limit of normal <br/ ><br>ï?· Absolute neutrophil count <500/mm3 <br/ ><br>or permicroliter <br/ ><br>ï?· Platelet count <100,000 per microliter or /mm3 <br/ ><br>6. Patients who received a platelet transfusion in the 5 days prior to enroll. <br/ ><br>7. Has any condition for which, in the opinion of the investigator, participation <br/ ><br>would not be in the best interest of the participant or that could prevent, limit, or <br/ ><br>confound the protocol-specified assessments including but not limited to: <br/ ><br>ï?· Participants who are not expected to survive longer than 48 hours at the time <br/ ><br>of randomization, or <br/ ><br>ï?· with patient on ventilator <br/ ><br>ï?· Previous history of Thoracic RT. <br/ ><br>ï?· History of hemodynamic intolerability <br/ ><br>ï?· CT finding with fibrotic changes <br/ ><br>ï?· Female patients with family history of breast cancer.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Test product- LDRT (Administered as 50 â?? 100 cGy): The study will be conducted with 100 patients. These 100 patients will be assessed for <br>safety and efficacy outcomes till Day 28 post the first dose of treatment administration.<br>Radiation Safety and efficacy data will be submitted to the regulatory authorities. <br>LDRT + Standard of Care or Standard of Care only for 5 days. The study includes up <br>to -4 to Day 1 of screening period and day 1 of treatment period and follow up of 28<br>days.<br>The total duration of study participation will be of 28 (±2) days from the study.<br>Control Intervention1: Standard of Care: The study will be conducted with 100 patients. These 100 patients will be assessed for <br>safety and efficacy outcomes till Day 28 post the first dose of treatment administration.<br>Radiation Safety and efficacy data will be submitted to the regulatory authorities. <br>LDRT + Standard of Care or Standard of Care only for 5 days. The study includes up <br>to -4 to Day 1 of screening period and day 1 of treatment period and follow up of 28<br>days.<br>The total duration of study participation will be of 28 (±2) days from the study.<br>→ | 1.Change from baseline oxygen saturation after 48 hours post irradiation, Day 3 and Day 7 post RT <br/ ><br>2.Time interval taken to reduce Oxygen demand upto 50% from baseline if on O2 support. <br/ ><br>3.Overall mortality rate at 28 days post radiation. <br/ ><br>4. CT severity score change from baseline on Day 7 to one week of post RT. <br/ ><br>5. Number of hospital stay days: <br/ ><br> Total number of days admitted in hospital after Radiotherapy <br/ ><br>6. Number of intubation events: <br/ ><br> Total number of intubation events after RadiotherapyTimepoint: 28 (±2)→ | | | | Yes | False | | |
| → | CTRI/2021/06/034293 | 7 September 2021 | The study of COVID infection in doctors, nursing staff,
lab technician,ward boys and aya
in the hospital | The study of COVID infection and
outcome in frontline workers at tertiary care centre -A prospective observational study | | ShriBMPatil Medical College | 18-06-2021 | 20210618 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56851 | Not Recruiting | No | | | | 19-06-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | S R Mudanur→ | | Department of OBG,BLDE(DU) University, Shri.B.M.Patil Medical College, BIJAPUR. Department of OBG,BLDE(DU) University, Shri.B.M.Patil Medical College, BIJAPUR.→ | drmudanurs@gmail.com→ | 9448820961→ | BLDE(DU) Research center→ | Inclusion criteria: all frontline warriors at tertiary care centre→ | Exclusion criteria: nil→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: Z758- Other problems related to medicalfacilities and other health care
→ | Intervention1: nil: nil<br>→ | effect covid 19 infection and outcome of frontline workers at tertiarty health care centreTimepoint: AT the base line level→ | | | | Yes | False | | |
| → | CTRI/2021/06/034301 | 7 September 2021 | To study the characteristics and outcomes of cancer patients with coronavirus (Covid 19) admitted to the intensive care unit in a Cancer Centre | To evaluate the characteristics and outcomes of cancer patients with coronavirus (Covid 19) admitted to the intensive care unit in a Tertiary Cancer Centre and identify risk factors that predict outcomes | | Tata Memorial Hospital | 18-06-2021 | 20210618 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57132 | Not Recruiting | No | | | | 28-06-2021 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr J V Divatia→ | | Dept. of Anaesthesia, Critical Care and Pain, Second Floor, Main Building, Tata Memorial Hospital Parel, Mumbai → | jdivatia@yahoo.com→ | 02224177041→ | Tata Memorial Centre→ | Inclusion criteria: All adult patients >18 years diagnosed with Covid-19 admitted to the Intensive Care unit in TMH→ | Exclusion criteria: Post Bone Marrow transplant→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | Intervention1: NA: NA<br>Control Intervention1: NA: NA<br>→ | Mortality in the ICU for cancer patients with covid-19Timepoint: At 30 day→ | | | | Yes | False | | |
| → | CTRI/2021/06/034302 | 7 September 2021 | Obstacles and Facilitators for physical activity in women with Polycystic Ovarian Syndrome(PCOS) during COVID-19 crisis | Barriers and Facilitators for physical activity in women with Polycystic Ovarian Syndrome(PCOS) during COVID-19 pandemic | | Visarapu Taraka Sai Bhavani | 18-06-2021 | 20210618 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56900 | Not Recruiting | No | | | | 15-07-2021 | 246 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Preetha R→ | | Department of Physiotherapy, Manipal Health College Professions, Manipal Academy of Higher Education → | preetha.r@manipal.edu→ | 9945670669→ | Manipal Academy of Higher Education→ | Inclusion criteria: women diagnosed to have Polycystic Ovarian syndrome <br/ ><br>women who have access to an internet enabled device→ | Exclusion criteria: Any neuromusculoskeletal conditions which prevent them from performing physical activity→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: E282- Polycystic ovarian syndrome
→ | | content validated barriers and facilitators for physical activity questionnaireTimepoint: Data will be collected in a single time point as it is a cross sectional study→ | | | | Yes | False | | |
| → | CTRI/2021/06/034303 | 7 September 2021 | Alternations of blood parameters corona positive patients. | Variations in the biochemical parameters of Covid-19 patients admitted in a tertiary care hospital of Dakshina Kannada : A retrospective study | | Dr Mahalaxmi S Petimani | 18-06-2021 | 20210618 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48824 | Recruiting | No | | | | 20-06-2021 | 147 | Observational | Other<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Mahalaxmi S Petimani→ | | Yenepoya Medical College
Deralakatte
Mangalore → | mahalaxmi.petimani@gmail.com→ | 09036560538→ | Yenepoya Medical College→ | Inclusion criteria: Covid-19 patients who are admitted in YMCH during 22nd June 2020 to 22nd September 2020 of any age and gender having all the required details like laboratory parameters in their case file and central laboratory data base.→ | Exclusion criteria: → | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | Variations in biochemical parameters in mild, moderate and severe covid patientsTimepoint: base line & 3 days→ | | | | Yes | False | | |
| → | CTRI/2021/06/034304 | 7 September 2021 | Effect of heartfulness meditation on perceived stress, sleep quality, and stress related biochemical parameters in recovered patients of novel COVID 19 | Effect of four-week heartfulness meditation on stress scores, sleep quality, oxidative and inflammatory biochemical markers in recovered patients of novel COVID 19 | | DST SATYAM | 18-06-2021 | 20210618 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56764 | Not Recruiting | No | | | | 21-06-2021 | 50 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Senthil Kumar S→ | | Department of Physiology First floor Medical College Building All India Institute of Medical Sciences Mangalagiri Andhra Pradesh Room no: 132, Department of Physiology First floor Out Patient Department Building All India Institute of Medical Sciences Man→ | senthil.kumar@aiimsmangalagiri.edu.in→ | 9962267560→ | AIIMS Mangalgiri→ | Inclusion criteria: Covid-19 positive patients got treated and cured as guidelines belong to age group of 18-50 years→ | Exclusion criteria: Patients with comorbid condition such as diabetes, hypertension or major organic disorders or not on any other treatments. <br/ ><br> <br/ ><br>Patients with any psychiatric illness.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Heartfullness meditation: online based heartfulness meditation. 40 minutes daily for 30 days. Two days online supervised every week. Remaining days self practice. Self record of meditation sessions in diary<br>Control Intervention1: Simple placebo relaxation: online based relaxation. 40 minutes daily for 30 days. self record of meditation sessions in diary<br>→ | sleep quality, perceived stress, oxidative stress, antioxidant stress, inflammatory biomarkers, complete blood countTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/06/034310 | 7 September 2021 | Employee satisfaction during covid 19 pandemic in tertiary hospital | Employee satisfaction during covid 19 pandemic | | Bristo Tomy | 18-06-2021 | 20210618 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56213 | Not Recruiting | No | | | | 23-06-2021 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Bristo Tomy→ | | Bristo Tomy
Department of Hospital Administration
Prasanna school of public health
MAHE → | somu.g@manipal.edu→ | 9448463186→ | Manipal academy of higher education→ | Inclusion criteria: Non teaching staffs <br/ ><br>Should know English <br/ ><br>Nurses,Housekeeping staffs,Clerks (part of the organisation )→ | Exclusion criteria: Only non teaching staffs other are excluded <br/ ><br>Patient <br/ ><br>Employees part of the organisation→ | | | Employee satisfaction level during covid 19 pandemicTimepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/06/034327 | 7 September 2021 | Viral Infection Study | Effect of short term inhaled Budesonide in children with mild COVID 19 infection an open labeled randomized controlled trial - NA | | Apollo Hospitals | 21-06-2021 | 20210621 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56875 | Not Recruiting | No | | | | 30-06-2021 | 150 | PMS | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Post Marketing Surveillance | India→ | Dr Ayesha Mariam→ | | Department of Paediatrics
Apollo Childrenâ??s Hospital
No. 15, Shafi Mohammed Road, Thousand Lights, Chennai → | ayesha.mariam@yahoo.com→ | | Apollo Childrenâ??s Hospital→ | Inclusion criteria: Confirmed diagnosis of COVID 19 infection(COVID RT-PCR positive or HRCT suggestive of CORADS 4/5/6) <br/ ><br>Mild disease presenting within the first 7 days of illness→ | Exclusion criteria: Children with moderate or severe COVID 19 infection at presentation. <br/ ><br>Children with comorbidities on immunosuppressants or on steroids. <br/ ><br>Parents or guardian not consenting to be part of the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Budesonide 400 mcg: twice daily for 7 days<br>Control Intervention1: Standard of Care: Vitamin C and zinc supplements<br>once daily for 14 days<br>→ | Effect on disease progression in children affected with COVID 19Timepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2021/06/034334 | 7 September 2021 | This study is to evaluate safety, efficacy and tolerability of Equine Anti Covid Antibody Fragments on Covid-19 hospitalized patients with moderate severity. | A prospective, randomized, multicentric, comparative Phase I/ Phase II clinical trial to evaluate the clinical safety, efficacy and tolerability of Equine Anti Covid Antibody Fragments F(abâ??)2 as an add on therapy to Standard of Care (SOC) in comparison to SOC alone in hospitalized adult subjects with COVID-19 infection, with moderate severity. | | VINS BioProducts Limited | 22-06-2021 | 20210622 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57079 | Not Recruiting | No | | | | 24-06-2021 | 212 | Interventional | Other<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 1/ Phase 2 | India→ | Dr Jayashri Krishnan→ | | Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4, Sector 27 D, Delhi Mathura Road, Near Sarai Khawja Metro Station,
Faridabad -121003, Haryana, India.
→ | sanjana.dawra@jssresearch.com→ | 8800831503→ | JSS Medical Research Asia Pacific Private Limited→ | Inclusion criteria: 1.Male or Female subjects of age 18-65 years (both inclusive) <br/ ><br>2.Subjects with documented laboratory confirmed COVID-19 infection with positive qualitative reverse transcriptaseâ??polymerase chain reaction (RT-PCR) <br/ ><br>3.Criteria for diagnosis of moderate COVID disease - Pneumonia with presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <93% (range 90-93%) on room air, Respiratory Rate more or equal to 24-30 per minute OR on low flow oxygen (up to 6 litres per minute to maintain saturation above 93%) <br/ ><br>4.For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative serum pregnancy test <br/ ><br>5.Eligible subjects of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the trial period and for at least 30 days following the last day of trial treatment administered. <br/ ><br>6.Not participating in any other interventional drug clinical studies before completion of the present trial <br/ ><br>7.Subjects with ability to understand and provide written informed consent form, which must have been obtained prior to screening. <br/ ><br>8.Subjects willing to comply with the protocol requirements. <br/ ><br>→ | Exclusion criteria: 1.Subjects with known hypersensitivity to any of the components of the formulation and/ or with prior allergic reaction due to contact or exposure to horses <br/ ><br>2.Subjects of COVID-19 disease, less than 18 years old <br/ ><br>3.History of anaphylaxis <br/ ><br>4.History of prior administration of equine serum (for example, anti-tetanus serum or anti-ophidic serum or anti-arachnid toxin serum) <br/ ><br>5.Subjects who have received or require treatment with convalescent plasma. <br/ ><br>6.Severe COVID-19 disease, defined as need for invasive or non-invasive ventilator support, ECMO or shock requiring vasopressor support. <br/ ><br>7.Other disease conditions: <br/ ><br>i.Medical history of Oncological Conditions since last 2 years <br/ ><br>ii.Known severe renal impairment, known case of asthma or chronic obstructive lung disease. <br/ ><br>iii.Severe liver disease: underlying liver cirrhosis or alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) elevated over 5 times the Upper Limit of Normal (ULN) <br/ ><br>8.Clinical prognostic non-survival, palliative care, and have no response to supportive treatment within three hours of hospital admission. <br/ ><br>9.Medical conditions that would limit subjectâ??s participation in the study as per Investigatorâ??s judgement. <br/ ><br>10.Females - Pregnant or lactating and/ or planning to conceive during the trial period. <br/ ><br>11.Subjects with autoimmune disease in the past, tested positive for human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C. <br/ ><br>12.Receipt of pooled immunoglobulin in last 90 days→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Equine Anti Covid Antibody Fragments F(abâ??)2 in addition to SOC: 3ml vial will be supplied for each patient that need to be diluted in 100ml NS and will be given at rate of 1ml/min<br>Control Intervention1: Standard of Care (SOC): SOC will be as per site MOHFW guidelines<br>→ | Phase I <br/ ><br>Primary Endpoint(s) - Safety <br/ ><br>Incidence of Serious Adverse Events <br/ ><br>Incidence of Treatment Emergent Adverse Events <br/ ><br>Incidence of related Serious Adverse Events <br/ ><br>Incidence of Grade 3 or 4 (severe) Adverse events <br/ ><br> <br/ ><br>Phase II <br/ ><br>Primary Endpoint(s) - Efficacy <br/ ><br>Time to Clinical recovery (TTCR) [Day 1 through Day 14] for which Day of recovery is defined as the first day on which the subject shows 2 point improvement in the ordinal scale. <br/ ><br> <br/ ><br>Timepoint: 30 days <br/ ><br> <br/ ><br>14 days→ | | | | Yes | False | | |
| → | CTRI/2021/06/034336 | 7 September 2021 | Surveying the Asian and African Research Ethics Committee Response to the Covid-19 Pandemic | Surveying the Asian and African Research Ethics Committee Response to the Covid-19 Pandemic - SAARECC19 | | FECAP | 22-06-2021 | 20210622 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56925 | Not Recruiting | No | | | | 15-07-2021 | 250 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Yashashri Shetty→ | | Dept of Pharmacology and Therapeutics, 1st floor, College building, Seth GS Medical College and KEM Hospital → | yashashrirajit@gmail.com→ | 9920069601→ | Seth GS Medical College and KEM Hospital→ | Inclusion criteria: Either gender adults→ | Exclusion criteria: → | | | To describe the operational readiness of RECs to conduct review during the Covid outbreakTimepoint: Data will be assessed at a single time point after the survey responses are received.→ | | | | Yes | False | | |
| → | CTRI/2021/06/034337 | 7 September 2021 | Covid 19 associated black fungus of nose and eyes | Covid associated Rhino-orbital mucormycosis | | Maulana Azad Medical College | 22-06-2021 | 20210622 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57086 | Not Recruiting | No | | | | 28-06-2021 | 70 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment: Blinding and masking: | N/A | India→ | Ravi Meher→ | | Department of ENT, B L Taneja Block, Maulana Azad Medical College, BSZ Marg, New Delhi Maulana Azad Medical College, BSZ Marg, New Delhi→ | ravimeher@gmail.com→ | 9968604237→ | Maulana Azad Medical College→ | Inclusion criteria: Any patient above 18 years of age with following complaints <br/ ><br>Nasal blockade or congestion, nasal discharge (bloody or brown/black), local pain <br/ ><br>Pain, numbness or swelling of facial skin <br/ ><br>Headache or blurred or double vision withpainin <br/ ><br> <br/ ><br>Toothache, loosening of maxillary teeth, jaw involvement <br/ ><br> 2. COVID -19 positive on nasopharyngeal RT-PCR or Chest CT suggestive of COVID- 19 less than 2 months old with mucormycosis confirmed on histopathology. <br/ ><br>Both criteria 1 and 2 must be met for inclusion in the study. <br/ ><br>→ | Exclusion criteria: Mucormycosis cases without a confirmed bout of preceding COVID-19→ | Health Condition 1: B461- Rhinocerebral mucormycosis
→ | Intervention1: nil: nil<br>→ | To identify the risk factors in causation of mucormycosis in COVID -19 patients.Timepoint: at baseline→ | | | | Yes | False | | |
| → | CTRI/2021/06/034340 | 7 September 2021 | Impact of reinforced awake proning on outcomes of COVID-19 pnemonia | : A cluster randomized trial of a behaviour change intervention to better implement awake PROning manoeuvRE in COVID-19 patiEnts: ( PRO- RECOVER RCT) - PRO- RECOVER RCT | | NONE | 22-06-2021 | 20210622 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57135 | Not Recruiting | No | | | | 30-06-2021 | 302 | Interventional | Cluster Randomized Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Soumya Umesh→ | | DEPARTMENT OF MEDICINE,
SJMCH,SARJAPUR ROAD,BANGALORE DEPARTMENT OF MEDICINE,
SJMCH,SARJAPUR ROAD,BANGALORE→ | drsoumya239@gmail.com→ | 08022065834→ | ST JOHNS MEDICAL COLLEGE AND HOSITAL→ | Inclusion criteria: CONSENTING COVID 19 PATIENTS HOSPITALISED FOR MILD,MODERATE,SEVERE DISEASE→ | Exclusion criteria: 1. Inability to prone due to mechanical reasons <br/ ><br>2. Heart failure NYHA Class 3/4 <br/ ><br>3. Decompensated Chronic Liver Disease with ascites <br/ ><br>4. Presence of Pneumothorax or Pneumomediastinum <br/ ><br>5. Critically Ill patients <br/ ><br>6. Intubated patients <br/ ><br>7. Morbid obesity <br/ ><br>8. Pregnancy <br/ ><br>9. Unstable Fractures <br/ ><br>10. Acute Hypercapnic respiratory failure <br/ ><br>11. Deep Vein Thrombosis (untreated <48hrs) <br/ ><br>12. Other contraindications to Prone position documented in the Case record by the treating physician. <br/ ><br>13. Intervention delayed beyond 48 hours of admission. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | Intervention1: MULTI-COMPONENT,EDUCATIONAL INTERVENTION TO INDUCE BEHAVIOUR CHANGE: EDUCATIONAL VIDEO, and leaflets that emphasise the importance of proning and ,TRACKERS TO RECORD TIME SPENT IN PRONE POSITION will be recorded daily for 7 days after recruitment or till discharge or occurrence of primary outcome which ever is earlier.Meanwhile all other treatment will be continued as per treating team which is as per institutional protocol.<br>Control Intervention1: non interventional arm will receive standard of care as per institutional protocol.: The treating team will continue the treatment as per <br> institutional protocol. They will be told to prone. However they will not receive the leaflet, video or tracker. Time spent in proning will be recorded on a daily basisFor 7 days. then they will be followed up till outcomes.<br>→ | Need for invasive or non invasive ventilation or the occurence of death.Timepoint: At baseline, then daily till 7 days in both arms. After this all patients will be followed up till discharge or death. Final outcome will be recorded at that time.→ | | | | Yes | False | | |
| → | CTRI/2021/06/034344 | 7 September 2021 | Is Tab Ivermectin and Cap Doxycycline taken before Inj Remdesivir helping in reducing mortality in severe Covid 19 patients? | Comparison of efficacy of Ivermectin and Doxycycline with Remdesivir versus Remdesivir in severe covid 19 cases â?? A Retrospective analysis | | Rajarajeshwari Medical College and Hospital | 23-06-2021 | 20210623 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57094 | Not Recruiting | No | | | | 24-06-2021 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Jyoti Petkar→ | | Department of Anaesthesiology, Rajarajeshwari Medical College and Hospital, #202, Kambipura, Mysore Road, Bengaluru → | jokiran2009@gmail.com→ | 07726899533→ | Rajarajeshwari Medical College and Hospital, Bangalore, state- Karnataka→ | Inclusion criteria: 1.Patients aged > 18 years <br/ ><br>2.Either Sex <br/ ><br>3.Confirmed cases of Covid-19 by RT-PCR <br/ ><br>4.Patients able to take oral drug. <br/ ><br>5.Patients requiring NIV or NRBM for maintaining saturation <br/ ><br>6. Patients who have started with Tab Ivermectin and Cap Doxycycline before admission to ICU <br/ ><br>7. Patients who have completed the Tab Ivermectin 12mg OD for 3 days and Cap Doxycycline 100mg BD for 5 days before admission in ICU <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1.Patients < 18 years <br/ ><br>2. Patients with drowsy on admission to ICU <br/ ><br>3. Patients who are drowsy and not able to take orally <br/ ><br>4.Patients who did not complete the Tab Ivermectin and Cap Doxycycline as per protocol <br/ ><br>5.Patients with Liver diseases. <br/ ><br>6.Patients with ischaemic heart disease. <br/ ><br>7.Pregnant or lactating women. <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To determine whether Tab Ivermectin and Tab Doxycycline started before Inj Remdesivir was associated with lower mortality rate in patients hospitalized with COVID-19 compared to patients treated with Inj Remdesivir only along with other standard treatment regimen.Timepoint: Followup at 14 days after discharge from ICU→ | | | | Yes | False | | |
| → | CTRI/2021/06/034345 | 7 September 2021 | Assessment of Psychosocial health status of adults due to COVID-19 pandemic in Mehrauli area of Delhi | Assessment of Psychosocial health of adults (18-60 yrs) during COVID-19 pandemic in Mehrauli area of Delhi | | Lady Hardinge Medical College | 23-06-2021 | 20210623 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50237 | Not Recruiting | No | | | | 25-06-2021 | 330 | Observational | Other<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | N/A | India→ | Alisha Raj→ | | Seminar 1,
Department of Community Medicine,
Lady Hardinge Medical College,
Cannaught Place-110001 → | prasuna.josyula@gmail.com→ | 9810481904→ | Delhi University→ | Inclusion criteria: All adults 18-60 yrs, both males and females in Mehrauli area of Delhi atleast for last 1 yr. <br/ ><br>→ | Exclusion criteria: Known or diagnosed cases of mental illness.→ | | Intervention1: NIL: NIL<br>→ | Proportion of adults having psychosocial health problems due to COVID-19 pandemicTimepoint: 1 year→ | | | | Yes | False | | |
| → | CTRI/2021/06/034352 | 7 September 2021 | Study of investigation tools in COVID 19 patients anx how it affects on patients outcome | Study of correlation of biomarkers in COVID 19 patients with patients outcome | | GCS medical college and hospital centre | 23-06-2021 | 20210623 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55512 | Not Recruiting | No | | | | 26-06-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Naman Dharmeshbhai Patel→ | | A/802 suryoday tower near sattadhar char rasta → | rrpatel9@gmail.com→ | 9825029273→ | Gcs medical college, hospital and research centre→ | Inclusion criteria: all age group, both sexes,including covid 19 rtpcr or hrct positive patients those who give consent for participation→ | Exclusion criteria: including all covid 19 patients those who refuse to give consent and who took dama as their outcomes are not favorable.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | correlation of the diagnostic and prognostic value of the serum biomarkers related to pandemic covid 19and assess the severity of its outcome s in current populationTimepoint: At the end of 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/06/034354 | 7 September 2021 | A survey of Clinical Research among the population of India in COVID times. | A Survey to Assess the Importance of Clinical Research Among population of India in Covid Era (Scientific Survey)
| | Medanta The Medicity | 23-06-2021 | 20210623 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57184 | Not Recruiting | No | | | | 26-06-2021 | 2000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Joby V George→ | | 10th Floor,Sector-38,Medanta The Medicity → | yatinmehta@hotmail.com→ | 0124-4141414→ | Institute of Critical Care and Anesthesia→ | Inclusion criteria: All general population of India→ | Exclusion criteria: Not Interested in participation→ | Health Condition 1: Z759- Unspecified problem related to medical facilities and other health care
→ | | Level of knowledge about Clinical ResearchTimepoint: 2 months→ | | | | Yes | False | | |
| → | CTRI/2021/06/034357 | 7 September 2021 | Mucormycosis and Anaesthesia | Anaesthetic implications of post-COVID mucormycosis in a tertiary care hospital, West Bengal, India - Mucor, Anaesthesia | | Dr Swati Datta | 23-06-2021 | 20210623 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57335 | Not Recruiting | No | | | | 01-07-2021 | 30 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Swati Datta→ | | Department - Anaesthesiology
Division - Green Building
Room - 2nd floor Tutor room No. 1
88 College Street
Kolkata - 700073
West Bengal India→ | drslahiri11@gmail.com→ | 9836979351→ | Medical College, Kolkata→ | Inclusion criteria: 1. Patients with RTPCR confirmed recent (with in last one & a half months) infection with SARS-COV-2 and current RTPCR negative status <br/ ><br>2. Presence of more than 1 of following clinical features: <br/ ><br>i) Frontal headache <br/ ><br>ii) Blurring of vision <br/ ><br>iii) Numbness of chick <br/ ><br>iv) Facial swelling <br/ ><br>v) Features suggestive of cranial nerve involvement <br/ ><br>vi) Nasal or sinus congestion <br/ ><br>vii) Black lesion on nasal bridge or upper inside of mouth (palatal region) <br/ ><br>3. Undergoing surgical resection of rhino-orbito-cerebral mucormycoses→ | Exclusion criteria: 1. COVID-19 RTPCR positive mucormycosis <br/ ><br>2. Patients with incomplete medical records <br/ ><br>3. Post COVID mucormycosis patients who are critically ill, not undergoing surgical treatment→ | Health Condition 1: B465- Mucormycosis, unspecified
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | 1. Sociodemographic profile of the post-COVID mucormycosis patients undergoing surgical intervention <br/ ><br>2. Etiology of increased frequency of mucormycosis in the post-COVID period <br/ ><br>3. Different anaesthetic challenges and ways to overcome them in post-COVID mucormycosis. <br/ ><br>4. Association, if any, of zinc supplementation with post-COVID mucormycosisTimepoint: One and half months→ | | | | Yes | False | | |
| → | CTRI/2021/06/034359 | 7 September 2021 | Evaluation of Equine antibody treatment in patient with COVID 19 infection | A Phase I, Randomized, Controlled, Open Label Study to Assess the Safety and Efficacy of COVID-19 Antiserum in Adult Patients with SARS-CoV-2/COVID-19 Disease. - SII-COVID19-EqS/IN-01 | | Serum Institute of India Pvt Ltd | 24-06-2021 | 20210624 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55706 | Not Recruiting | No | | | | 24-06-2021 | 40 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 1 | India→ | Dr M V Khadilkar→ | | Serum Institute of India Pvt. Ltd.
212/2, Off Soli Poonawalla Road, Hadapsar, Pune → | drhjs@seruminstitute.com→ | 91-20-26602451→ | Serum Institute of India Pvt. Ltd.→ | Inclusion criteria: 1.Adult Male or Female patients aged 18 to 45 years (both Inclusive) <br/ ><br> <br/ ><br>2. Patients with COVID-19 disease confirmed by RT-PCR at screening. The latest RT-PCR test result should be within 3 days prior to randomization/ first dose of investigational product <br/ ><br>3. Patients with a COVID-19 disease whose first symptom onset is â?¤ 7 days from first dose of investigational product <br/ ><br>4.Patients requiring hospitalization for treatment of COVID-19 infection and who fulfil a score of either 4 or 5 on the WHO 10-point Progression Scale at randomization/prior to administration of first dose of IP <br/ ><br>5.Oxygen saturation (SPO2) between 90% to 93% (both inclusive) on room air at randomization/ prior to administration of first dose of IP <br/ ><br>6.Capable and willing to provide written informed consent prior to the performance of any study- specific procedures.→ | Exclusion criteria: 1.Patients with known allergies to equine serum or to any component of Equine antiserum <br/ ><br>2.Patients with past medical history of Serum Sickness <br/ ><br>3.Patients with history of anaphylaxis or severe allergic reactions to a vaccine, food, drug, toxin or other exposure <br/ ><br>4.Patients who have received convalescent plasma or immunoglobulin for COVID-19 disease <br/ ><br>5.Patients who have received convalescent plasma or immunoglobulin for conditions other than COVID-19 disease within 3 months prior to first dose of investigational product <br/ ><br>6.Patients who are admitted in the Intensive Care Unit (ICU) or under invasive mechanical ventilation and/or extracorporeal membrane oxygenation at randomization/prior to first dose of investigational product <br/ ><br>7.Patients with severe COVID-19 disease including those with severe pneumonia, moderate to severe Acute Respiratory Distress Syndrome, Sepsis and/or Organ failure <br/ ><br>8.Patients who are expected to be referred to another institution within 72 hours of enrolment, which prevents proper follow-up of that patient <br/ ><br>9.Patients whose progression to death due to COVID-19 disease is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment as assessed by the Investigator <br/ ><br>10.Pregnant or breastfeeding women <br/ ><br>11.Known history of human immunodeficiency virus (Types 1 or 2) antibody, hepatitis B surface antigen, or hepatitis C virus antibody. <br/ ><br>12.Participating in any other study and have received any other investigational medication or device within 30 days prior to randomization or are taking part in a non-medication study which, in the opinion of the Investigator, would interfere with the interpretation of the assessments in this study. <br/ ><br>13.Any other medical condition which in the opinion of the Investigator may affect the patientsâ?? safety or study participation and conduct <br/ ><br>14.Presence of any other severe/uncontrolled concurrent medical condition other than COVID-19 disease which precludes the patient from study participation in the interest of patient safety, as judged by the Investigator. <br/ ><br>15.Receipt of ant COVID-19 vaccine (Licensed/EUL/under trial) <br/ ><br>16.Patients re-infected with SARS-CoV-2/COVID-19 disease. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Equine COVID-19 Antiserum [F(ab)2] Along with Standard of care.: The Dose of the IP is 1ml diluted in 100ml NS will be administered as an IV infusion. Total 3 doses with an interval of 24 hours between two doses, along with standard of care for treatment of COVID-19 positive patients.<br>Control Intervention1: Standard of Care: Treatment as per current treatment guidelines and institutes practice for COVID-19 positive patients will be administered<br>→ | â?¢ To assess the safety of COVID-19 Antiserum when administered as three doses, 24 hours apart, in adult patients aged 18-45 years with SARS-COV-2/COVID- 19 disease.Timepoint: Through Day 28/EOS→ | | | | Yes | False | | |
| → | CTRI/2021/06/034373 | 7 September 2021 | A clinical trial of Intravenous Aviptadil along with standard treatment in Subjects Hospitalized with Respiratory failure/acute respiratory distress syndrome associated
with severe Coronavirus Disease (COVID-19). | A Randomized, Double blind, Placebo controlled Multi-centric, Phase
III Clinical Trial to Evaluate the Efficacy and Safety of Aviptadil for
Injection 500 mcg/vial in Treatment of Subjects Hospitalized with
Respiratory failure/acute respiratory distress syndrome associated
with severe Coronavirus Disease (COVID-19) | | MSN Laboratories Private Limited | 24-06-2021 | 20210624 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57078 | Recruiting | No | | | | 25-06-2021 | 152 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | K Ravinder Reddy→ | | Plot No C-24, MSN House, Industrial Estate, Sanath Nagar, Hyderabad → | aditi.datta@biositeindia.com→ | 08040560670→ | Biosite Research Private Limited→ | Inclusion criteria: 1. Male or female subjects having age 18 years to 60 years. <br/ ><br>2. Subject and/or his/her legally accepted representative willing to give written informed consent. <br/ ><br>3. Subjects having Critical COVID-19 with ARDS/respiratory failure requiring either mechanical ventilation, non-invasive <br/ ><br>ventilation, or high flow rate nasal cannula at minimum 20L flow and 50% FIO2. <br/ ><br>(Severe cases of COVID-19 as per MoH & FW guidelines on â??Clinical Management Protocol: COVID-19â?? as updated from <br/ ><br>time to time. Case of severe COVID-19 defined as presence of clinical features of pneumonia (fever, cough, dyspnea and/ or hypoxia) with any of the following: <br/ ><br>ï?· SpO2 <90% on room air <br/ ><br>ï?· Severe respiratory distress <br/ ><br>ï?· Respiratory rate more than 30 per minute→ | Exclusion criteria: 1. Subject with history of hypersensitivity to Aviptadil or to any of the excipient. <br/ ><br>2. Subjects on Mechanical ventilation for more than 7 days. <br/ ><br>3. Transplant subjects currently immunosuppressed; <br/ ><br>4. Subjects with Chemotherapy-induced neutropenia <br/ ><br>(granulocyte count <1000/mm3); <br/ ><br>5. Subjects with Cardiogenic shock; congestive heart failure â?? NYHA Class 3 or 4; <br/ ><br>6. Subjects with Recent myocardial infarction â?? within last 6 months and troponin > 0.5. <br/ ><br>7. Subjects with anuria (urine output < 50 ml/d) or other signs of multi-organ failure; <br/ ><br>8. Irreversible condition (other than COVID-19) with projected fatal course. <br/ ><br>9. Requirement of Extracorporeal membrane oxygenation (ECMO) <br/ ><br>10. Severe liver disease with portal hypertension; <br/ ><br>11. Recent stroke or head trauma within last 12 months <br/ ><br>12. Increased intracranial pressure, or other serious neurologic disorder; <br/ ><br>13. Liquid Diarrhea more than 3x/day; defined as more than 3 non-bloody watery stools within a 24-hour period, requiring additional fluid and electrolyte supplementation. <br/ ><br>14. Hypotension (i.e. Mean Arterial Pressure <65mmHg) that cannot be managed with pressors <br/ ><br>15. Female subjects who are pregnant or lactating or planning to become pregnant during the study period. <br/ ><br>16. Concurrent participation in another clinical trial or any investigational therapy within 90 days prior to signing informed consent. <br/ ><br>17. Subjects with history of HIV and or Hepatitis B and or Hepatitis C. <br/ ><br>18. Suspected inability or unwillingness to comply with the study procedures. <br/ ><br>19. Subjects with clinically significant disorder that, in the opinion of the investigator, would result in jeopardizing patientâ??s safety and efficacy of the drug. <br/ ><br>20. Participation in any clinical study during last three months.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Aviptadil for Injection 500 mcg/vial and standard of care (SOC): Subjects will be treated with investigational product Aviptadil by IV<br>infusion over 12 hours in escalating doses from 50/100/150 pmol/kg/hr on three consecutive days with Standard of Care.The Standard of Care will be as per individual Hospital protocol. It will be kept as close to the government treatment protocol as possible.<br>Control Intervention1: Placebo and standard of care (SOC).: Placebo by IV infusion over 12 hours in escalating doses from 50/100/150 pmol/kg/hr on three consecutive days. The Standard of Care will be as per individual Hospital protocol. It will be kept as close to the government treatment protocol as possible.<br>Control Intervention2: Placebo and standard of care (SOC).: Placebo by IV infusion over 12 hours in escalating doses from 50/100/150 pmol/kg/hr on three consecutive days. The Standard of Care will be as per individual Hospital protocol. It will be kept as close to the government treatment protocol as possible.<br>Control Intervention3: Placebo and standard of care (SOC).: Placebo by IV infusion over 12 hours in escalating doses from 50/100/150 pmol/kg/hr on three consecutive days. The Standard of Care will be as per individual Hospital protocol. It will be kept as close to the government treatment protocol as possible.<br>Control Intervention4: Placebo and standard of care (SOC).: Placebo by IV infusion over 12 hours in escalating doses from 50/100/150 pmol/kg/hr on three consecutive days. The Standard of Care will be as per individual Hospital protocol. It will be kept as close to the government treatment protocol as possible.<br>→ | Recovery from Respiratory failure or ARDS by day 28 <br/ ><br>(Recovery is defined as being able to maintain a physiologic <br/ ><br>oxygen saturation (SaO2) without the need for mechanical ventilation, non-invasive ventilation, or high-flow Nasal Oxygen above 20L/min)Timepoint: Recovery from Respiratory failure or ARDS by day 28 <br/ ><br>(Recovery is defined as being able to maintain a physiologic <br/ ><br>oxygen saturation (SaO2) without the need for mechanical ventilation, non-invasive ventilation, or high-flow Nasal Oxygen above 20L/min)→ | | | | Yes | False | | |
| → | CTRI/2021/06/034375 | 7 September 2021 | An Observational study to check safety and effectiveness of CASIRIVIMAB/ IMDEVIMAB treatment of mild/moderate covid 19 patients in India | Non-Interventional Observational Study Assessing Safety And Efficacy Of Neutralizing Monoclonal Antibody (Casirivimab/ Imdevimab) Treatment In A Real-World-Setting Of Mild/Moderate Covid-19 Patients In India | | Roche Products India Pvt Ltd | 24-06-2021 | 20210624 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56192 | Recruiting | No | | | | 05-07-2021 | 200 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Post Marketing Surveillance | India→ | Priyanka Bhattacharya→ | | 146-B, 166 A, Unit No. 7, 8, 9
8th Floor, R City Office, R City Mall, Lal Bahadur Shastri Marg
Ghatkopar, Mumbai → | sneha.singh.ss1@roche.com→ | | Roche Products India Private Limited→ | Inclusion criteria: 1. confirmed covid-19 infection <br/ ><br>2. Does not require oxygen <br/ ><br>3. Symptoms are mil/moderate <br/ ><br>4 At high risk for sever Covid 19 infection→ | Exclusion criteria: 1. hospitalized due to COVID-19 <br/ ><br>2. Require oxygen therapy due to Covid-19 <br/ ><br>3. Require an increase in baseline oxygen flow rate due to Covid-19 <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | The purpose of this study is to assess the real-world safety and efficacy of neutralizing monoclonal antibody (casirivimab/imdevimab) treatment in mild/moderate COVID-19 patients in India, who are at high risk of severe COVID-19 and do not require oxygenTimepoint: The neutralizing antibody will be administered at the baseline visit (Day 0). Visits 1, 2, 3 and 4 will be conducted by phone, at days 7, 14, 28 and 90. Data Collected during Observational Period.→ | | | | Yes | False | | |
| → | CTRI/2021/06/034381 | 7 September 2021 | Effect of pranayama on mental health of nurses taking care of COVID-19 patients | Effect of pranayama on mental health of nurses caring COVID-19 patients: A randomized waitlist controlled trial | | Dr Monali D Mathad | 25-06-2021 | 20210625 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57142 | Not Recruiting | No | | | | 01-07-2021 | 160 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Dr Monali D Mathad→ | | Department- Nursing Foundation,
Division- Nursing,
Kempegowda College of Nursing,
K R Road, V V Puram, Bangalore → | mathad.kwr@gmail.com→ | 09620266523→ | Kempegowda College of Nursing→ | Inclusion criteria: Nurses taking care of COVID-19 patients <br/ ><br>Willing to participate in the study→ | Exclusion criteria: Regular yoga practitioner, <br/ ><br>Diagnosed and on treatment for neurological especially epilepsy or psychiatric condition, <br/ ><br>Diagnosed and on treatment for Diabetes, Hypertension, Renal disorder or Cancer, <br/ ><br>Recent major abdominal or thoracic surgery, <br/ ><br>COVID-19 positive <br/ ><br>→ | | Intervention1: Experimental group<br>Pranayama Practice: Daily practice for 30 minutes upto 8 weeks,<br>Pranayama practices include<br>Deep Abdominal Breathing<br>Anulom Vilom Pranayama<br>Bhramari Pranayama<br><br>Control Intervention1: Waitlist Controlled group<br><br>: Pranayama will be taught after completion of 8 weeks<br>→ | Burnout <br/ ><br>Compassion Fatigue <br/ ><br>Compassion Satisfaction <br/ ><br>Self-CompassionTimepoint: 0, 4, 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/06/034392 | 7 September 2021 | To study the clinical profile and outcome in chronic kidney disease stage 5 patients with COVID-19 infection on dialysis | Clinical Profile and Outcomes In Chronic Kidney Disease Stage 5 Patients On Dialysis Hospitalised With COVID-19 Infection | | Dr RS Ahlawat Maulana Azad Medical College | 25-06-2021 | 20210625 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49816 | Recruiting | No | | | | 20-07-2021 | 30 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | DR RS Ahlawat→ | | Maulana Azad Medical College And Associated Lok
Nayak, G.I.P.M.E.R. AND G.N.E.C. Hospitals, Bahadur
Shah Zafar Marg, New Delhi → | ahlawat.ravi@gmail.com→ | 9873417136→ | Maulana Azad Medical College And Associated Lok Nayak, G.I.P.M.E.R. AND G.N.E.C. Hospitals→ | Inclusion criteria: Chronic kidney disease stage 5 patients on dialysis→ | Exclusion criteria: Patients on immunosuppressive chemotherapy Patients living with HIV-AIDS (PLWHA) Patients with known malignancy→ | Health Condition 1: N185- Chronic kidney disease, stage 5
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To study clinical profile and outcomes in chronic kidney disease stage 5 patients on dialysis hospitalized with COVID-19 infection.Timepoint: less than or equal to 1 year→ | | | | Yes | False | | |
| → | CTRI/2021/06/034400 | 7 September 2021 | To assess immunity level after giving vaccine to health care workers | Study on detection of COVID-I9 post vaccination antibody levels and immune cells in health care workers | | Dr Mangyarkarasi V | 25-06-2021 | 20210625 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55927 | Recruiting | No | | | | 18-07-2021 | 250 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Vivekanand Kattimani→ | | Ground Floor, Room No-3, Department of Oral and Maxillofacial Surgery, SIBAR Institute of Dental Sciences, Guntur Post- Takkellapdu, Mandalam- Pedakakani
→ | mangai.micro@aiimsmangalagiri.edu.in→ | 9840410566→ | All India Institute of Medical Sciences, Mangalagiri→ | Inclusion criteria: Adult health care workers aged between 18 - 50 years attending for COVID-I9 vaccination camp at AIIMS Mangalagiri and Sibar Institute of Dental Sciences Guntur→ | Exclusion criteria: Patients on steroids, severe comorbid illness, children and pregnant women→ | | | Antibody LevelTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/06/034404 | 7 September 2021 | safety and efficacy of homoeopathic remedy EpiphaniQ in adult patients with mild to moderate COVID-19: | A Phase 2 evaluation of the safety and efficacy of homoeopathic remedy EpiphaniQ in adult patients with mild to moderate COVID-19: Randomized, open label, controlled, multicenter trial | | EpiphaniQ LLP | 25-06-2021 | 20210625 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56666 | Recruiting | No | | | | 28-06-2021 | 200 | Interventional | Other<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2 | India→ | MrPathik Divate→ | | First floor Jehangir Hospital Premises 32 Sassoon Road → | drpiyushchaudhari85@gmail.com→ | 9341313022→ | Jehangir Clinical Development Centre.Pvt.Ltd→ | Inclusion criteria: Hospitalized patient with laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or Rapid Antigen Test as documented by either of the following: PCR positive in sample collected < 72 hours prior to randomization; OR PCR positive in sample collected â?¥ 72 hours prior to randomization with documented inability to obtain a repeat sample (e.g. due to lack of testing supplies, limited testing capacity, results taking >24 hours, etc.) <br/ ><br>2. Subject (or legally acceptable representative) understands and agrees to comply with planned study procedures and provides informed consent prior to initiation of study procedures. <br/ ><br>3. Male or non-pregnant female adult â?¥18 years of age at time of enrolment. <br/ ><br>4. For mild cases subjects without evidence of breathlessness or Hypoxia (normal saturation) <br/ ><br>5. For moderate cases Illness with â?¤12 days duration, and at least one of the following: i. Radiographic infiltrates by imaging captured during the period between date of admission to date of enrolment (chest x-ray, CT scan, lung ultrasound, and etc.), OR ii. Presence of clinical features of dyspnea and or hypoxia, fever cough including Respiratory rate > 24 breaths/min OR SpO2 90 to â?¤ 93% on room air, OR iii. Requiring supplemental oxygen. <br/ ><br>6. Women of childbearing potential must agree either to abstinence or to use at least one primary form of contraception not including hormonal contraception from the time of screening till end of the study. <br/ ><br>7. Subject (or legally acceptable representative) agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 till end of this study. <br/ ><br>8. Subject (or legally acceptable representative) is willing to be a study participant and to accept randomization to any assigned treatment arm. <br/ ><br>→ | Exclusion criteria: A subject will not be eligible for inclusion in this study if ANY of the following criteria apply: <br/ ><br>1. Physician makes a decision that trial involvement is not in patientâ??s best interest, or there is any condition that does not allow the protocol to be followed safely. <br/ ><br>2. Patient already in, or has already been in, another clinical trial of an experimental treatment for COVID-19 <br/ ><br>3. Patient has a PaO2/FiO2 ratio < 200 or is requiring IMV/ECMO at baseline. <br/ ><br>4. Known medical history of allergy to Zn <br/ ><br>5. Severe hepatic impairment defined as Child C liver disease. <br/ ><br>6. eGFR â?¤ 30 mL/min/1.73 m2 (defined using CKD-EPI SCr formula) <br/ ><br>7. History of any organ transplant which requires active immunosuppressive treatment which can interfere with kidney function <br/ ><br>8. If a patient required cardiopulmonary resuscitation (CPR) within 14 days <br/ ><br>9. Already receiving dialysis (either acute or chronic) or imminent need of dialysis at the time of enrolment <br/ ><br>10. Patients with a known or suspected history of oxalate nephropathy or hyperoxaluria, scurvy, chronic iron overload, G-6PD deficiency <br/ ><br>11. Patients with known or suspected history of cardiovascular disease and LVEF below 30% <br/ ><br>12. Patient not ready to discontinue the use of multivitamin and Zinc formulations which in the opinion of investigator may interfere with the study. <br/ ><br>13. Any patient which in the opinion of the principal investigator may worsen in next 72 hours. <br/ ><br>→ | Health Condition 1: B342- Coronavirus infection, unspecified
→ | Intervention1: EpiphaniQ : Therapeutic formulation with Zinc Iodide. EpiphaniQ is an FDA registered homeopathic OTC drug to treat respiratory difficulties, cough and pertussis that can be orally administered.a 10 ml of EpiphaniQ liquid will be mixed<br>with 150 ml-200ml of water or juice and administered orally within 2-3 hours of meal three times<br>in a day for 14 consecutive days. Total duration for which EpiphaniQ is administered will be 14<br>days.<br>Control Intervention1: nil: nil<br>→ | Frequency of treatment emergent adverse events (TEAEs)Timepoint: From Baseline to End of study (EOS) or Day 28, as applicable→ | | | | Yes | False | | |
| → | CTRI/2021/06/034414 | 7 September 2021 | Online Classes and neck Pain in Undergraduate & Postgraduate Medical Students: A Study of Prevalence and Associated Factors | The Effect of Online Classes during COVID-19 pandemic on Cervical Axial Pain in Undergraduate and postgraduate Medical Students: A cross sectional study of prevalence and associated factors. | | AIIMS | 28-06-2021 | 20210628 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57141 | Not Recruiting | No | | | | 05-07-2021 | 400 | Observational | Single Arm Trial<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Reni Benny→ | | Department of PMR
AIIMS
New Delhi → | wadhwadr@gmail.com→ | 9811854584→ | AIIMS, New Delhi→ | Inclusion criteria: 1. All undergraduate & postgraduate medical students in AIIMS, New Delhi <br/ ><br>2. Age â?¥ 18 years <br/ ><br>→ | Exclusion criteria: 1. Known structural deformity of the spine <br/ ><br>2. Known inflammatory joint diseases <br/ ><br>3. History of radicular pain in the upper limb <br/ ><br>4. History of violent trauma to the neck <br/ ><br>5. History of previous spinal surgeries <br/ ><br>6. History of neurological deficits <br/ ><br>7. Refusal to participate in the study <br/ ><br>→ | Health Condition 1: M542- Cervicalgia
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. To estimate the prevalence of cervical axial pain in undergraduate & postgraduate medical students after starting of the online classesTimepoint: base line→ | | | | Yes | False | | |
| → | CTRI/2021/06/034428 | 7 September 2021 | Correlation between serum ferritin and COVID-19 severity | The association between serum ferritin and clinical outcomes in novel coronavirus 19 infections | | Kasturba Medical College and Hospital MAHE Manipal | 28-06-2021 | 20210628 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54880 | Not Recruiting | No | | | | 30-06-2021 | 500 | Observational | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Shubhada→ | | Department of Medicine,
KMC, Manipal Academy of Higher Education, Manipal → | shubhada_u@yahoo.co.in→ | 9844465447→ | Kasturba Medical College, Manipal→ | Inclusion criteria: Inclusion criteria: All patients with diagnosed COVID 19 infection (swab RT PCR positivity) who are admitted and treated in our facility as in→ | Exclusion criteria: 1. Age <18years <br/ ><br>2. Anemias like iron deficiency anemia, anemia of chronic disease etc <br/ ><br>3. Acute inflammatory conditions at the time of diagnosis of COVID 19 like acute pancreatitis, acute myocardial infarction <br/ ><br>4. Pregnant women→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | 1.Need for ventilation, ICU stay <br/ ><br>Timepoint: 1.Need for ventilation, ICU stay <br/ ><br>2. Death→ | | | | Yes | False | | |
| → | CTRI/2021/06/034433 | 7 September 2021 | Clinical study on IMMUNODAATâ?¢ Botanical Ingredient, in Post Covid-19 recovery | A Prospective, Randomized, Open Label, Two arm, Comparative Clinical Study to Evaluate the effect of IMMUNODAATâ?¢ Botanical Ingredient, in Post Covid-19 recovery - NIL | | LODAAT PHARMA | 29-06-2021 | 20210629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57154 | Recruiting | No | | | | 30-06-2021 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Sanjay Tamoli→ | | Target Institute of Medical Education and Research
Department of
Medical Services, 4th Floor, A 402-A,B,C, Jaswanti Allied center,
Ramchandra lane extn, Kachpada, Malad W, Mumbai → | targetinstitute@yahoo.com→ | 9322522252→ | Target Institute of Medical Education and Research→ | Inclusion criteria: 1. Patients who had mild to moderate symptoms [as per US-CDC classification) of COVID-19 (Ref: www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-guidance-management-patients.html) (Mild symptoms up to mild pneumonia) and is recovered clinically. <br/ ><br>2. Patients will be recruited from the day of clinical recovery till next 15 days and having Post Covid Symptoms as per https://www.cdc.gov/coronavirus/2019-ncov/long-term-effects <br/ ><br>3. Ready to provide written informed consent for participation in the study <br/ ><br>4. Willing to follow COVID-19 (prevention and containment) related guidelines issued from time to time by Govt. / local health authority throughout the study period. <br/ ><br>→ | Exclusion criteria: 1. Subjects who had severe COVID-19 (moderate to severe pneumonia) <br/ ><br>2. Subjects with post COVID 19 complications (those who had gone into severe type of COVID-19) <br/ ><br>3. Chronic, Severe, Unstable, Uncontrolled co-existent medical illness such as, Hypertension, Cardiac disorders, liver, kidney disorders and lung disorders or other disease of concern which may put the patient at increased risk during the study <br/ ><br>4. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment. <br/ ><br>5. Subjects having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening <br/ ><br>6. Subjects having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc. <br/ ><br>7. Subjects taking steroid treatment and or any kind of immunosuppressive therapy prior to participation in the study <br/ ><br>8. Allergies, known to be allergic to IMMUNODAATâ?¢ Botanical Ingredient <br/ ><br>9. Any other conditions which in the opinion of investigator will place the subject at risk or will influence the conduct of study or interpretation of results <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: IMMUNODAATâ?¢ Botanical Ingredient: IMMUNODAATâ?¢ Botanical Ingredient Contains 250 mg elderberry extracts (Sambucus nigra L.) <br><br>Dosage and Treatment Duration: Subjects will be advised to take<br>IMMUNODAATâ?¢ Botanical Ingredient in a dose of 1 capsule twice daily orally for 30 days + Conventional management (Standard of Care) as prescribed / advised by concerned health authorities for 30 days<br><br>Control Intervention1: Conventional management (Standard of Care): Conventional management (Standard of Care)<br><br>Dosage and Treatment Duration: Subjects will be advised to take<br>Conventional management (Standard of Care) as prescribed / advised by concerned health authorities for 30 days<br><br>→ | 1. Comparative changes in post-clinical recovery from COVID-19 (signs/symptoms/lab parameters) <br/ ><br>2. Comparative assessment on blood related parameters like hematology, ESR and CRP from baseline to 30 days. <br/ ><br>Timepoint: Day -3, Day 0, Day 15, Day 30→ | | | | Yes | False | | |
| → | CTRI/2021/06/034434 | 7 September 2021 | comparision of Bains circuit with Non-Rebreathing mask as oxygenation device | THE effectiveness of Bains circuit in improving Oxygenation and reducing the total Oxygen consumption in patients with Severe COVID 19 disease - bains vs nrbm | | Mahatma Gandhi Institute of Medical Sciences | 29-06-2021 | 20210629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56931 | Recruiting | No | | | | 30-06-2021 | 72 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | NISHA JHA→ | | Dept. Of Anesthesiology,
MGIMS, Sewagram → | nishajha1811@gmail.com→ | 9309152562→ | MGIMS, Sewagram→ | Inclusion criteria: 1.Confirmed cases of COVID 19 disease (RT â?? PCR positive) <br/ ><br>2.Cases of Severe COVID 19 disease with high Oxygen requirement i.e. not maintaining saturation above 92% with 12 l Oxygen flow via NRB masks <br/ ><br>→ | Exclusion criteria: 1.patient not willing to be a part of the study <br/ ><br>2.patients having severe cough <br/ ><br>3.pregnant patients and children below 12 years of age <br/ ><br>4.patients not maintaining saturation >90% with maximum FGF (15 l) with either Bains or NRBM at 15 minutes of starting of Oxygen therapy for whom mechanical ventilation could be arranged <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Bains Circuit as Oxygen Therapy Device: if oxygen requirement increases more than 8 l NRBM , patients will be randomized.<br> patients in group B will be oxygenated using Bains circuit <br>end point- as long as oxygen requirement greater than 8 l<br>spo2 more than 90<br>RR less than 40<br><br><br>Control Intervention1: Non Rebreathing Masks: NRB masks are conventionally used to OXygenate patients of moderate to severe COVID disease .<br>→ | 1.Improved Oxygenation in terms of spO2 levels, and pA O2 levels <br/ ><br>2.Decreased Total Oxygen requirement <br/ ><br>Timepoint: till the patient is oxygenated using any of the study devices→ | | | | Yes | False | | |
| → | CTRI/2021/06/034435 | 7 September 2021 | Secondary infection happened in Covid -19 patients at tertiary care center of vadodara. | Prevelance of secondary infection in Covid-19 patients at tertiary care center of vadodara | | Viramgami karan hiteshkumar | 29-06-2021 | 20210629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56977 | Not Recruiting | No | | | | 30-06-2021 | 50 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Viramgami karan hiteshkumar→ | | 206 No, 2nd Floor, Gmers medical collage and hospital gotri,
Near Natubhai circle,
Vadodara. 206 No, 2nd Floor, Gmers medical collage and hospital gotri,
Near Natubhai circle,
Vadodara.→ | dranandkpatel@gmail.com→ | 9879771079→ | GMERS MEDICAL COLLEGE AND HOSPITAL GOTRI→ | Inclusion criteria: (1)Age more than 18 years <br/ ><br>(2)RTPCR/RAT for covid 19 positive patients→ | Exclusion criteria: NIL→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | Bacteria or fungi causes secondary infection in Covid 19 patients will be identified.Timepoint: In 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/06/034442 | 7 September 2021 | Safety and efficacy of Monovalent and Bivalent Recombinant Protein Vaccines against COVID-19 in Adults 18 Years of Age and Older | A parallel-group, Phase III, multi-stage, modified double-blind, multi-armed study to assess the efficacy, safety, and immunogenicity of two SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (monovalent and bivalent) for prevention against COVID-19 in adults 18 years of age and older | | Sanofi Healthcare India Private Limited | 29-06-2021 | 20210629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56682 | Recruiting | No | | | | 06-07-2021 | 37430 | Interventional | Other<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 3 | Colombia;Dominican Republic;Ghana;Honduras;India;Japan;Kenya;Mexico;Nigeria;Pakistan;Sri Lanka;Uganda;United States of America→ | Dr Somnath Mangarule→ | | 4th Floor Vasantha Chambers Fateh Maidan Road
Basheer Bagh Hyderabad
→ | Somnath.Mangarule@sanofi.com→ | 04066301502→ | Sanofi Healthcare India Private Limited→ | Inclusion criteria: 1. Aged 18 years or older on the day of inclusion. <br/ ><br>2. For persons living with HIV, stable HIV infection determined by participant currently on antiretroviral with CD4 count more than 200/mm3. <br/ ><br>3. SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect presence of SARS-CoV-2 antibodies. <br/ ><br>4. Does not intend to receive an authorized/approved COVID-19 vaccine despite encouragement by the Investigator. <br/ ><br>5. A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: <br/ ><br>â?¢Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be post-menopausal for at least 1 year or surgically sterile. <br/ ><br>OR <br/ ><br>â?¢Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the first study intervention administration until at least 12 weeks after the second study intervention administration. <br/ ><br>A participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours before any dose of study intervention. <br/ ><br>6. Informed consent form has been signed and dated. <br/ ><br>7. Able to attend all visits and to comply with all study procedures. <br/ ><br>8. Covered by health insurance, only if required by local, regional or national regulations→ | Exclusion criteria: 1. Known systemic hypersensitivity to any of the vaccine components, or history of a life- threatening reaction to a vaccine containing any of the same substances. <br/ ><br>2. Dementia or any other cognitive condition at a stage that could interfere with following the study procedures based on Investigatorâ??s judgment. <br/ ><br>3. Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based on Investigatorâ??s judgment. <br/ ><br>4. Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding inclusion, contraindicating IM vaccination based on Investigatorâ??s judgment. <br/ ><br>5. Unstable acute or chronic illness that in the opinion of the Investigator or designee poses additional risk as a result of participation or that could interfere with the study procedures. <br/ ><br>6. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (temperature more than equal to 38.0°C [more than equal to 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided. <br/ ><br>7. Receipt of any vaccine in the 30 days preceding or on the day of the first study vaccination or planned receipt of any vaccine between the first study vaccination and in the 30 days following the second study vaccination except for influenza vaccination, which may be received at any time in relation to study intervention. <br/ ><br>8. Prior administration of a coronavirus vaccine (severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2], SARS-CoV, Middle East Respiratory Syndrome [MERS-CoV]). <br/ ><br>9. Receipt of solid-organ or bone marrow transplants in the past 180 days. <br/ ><br>10. Receipt of anti-cancer chemotherapy in the last 90 days. <br/ ><br>11. Participation at the time of study enrollment (or in the 30 days preceding the first study vaccination) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure. <br/ ><br>12. Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily. <br/ ><br>13. Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study.→ | | Intervention1: Monovalent vaccine: Recombinant adjuvanted COVID-19 monovalent vaccine [CoV2 PreS dTM ASO3 monovalent vaccine (D614)] will be administered as two dose series at D01 and D22 in STAGE 1 Participants, by IM route<br>Intervention2: Bivalent Vaccine: Recombinant adjuvanted COVID-19 bivalent vaccine [CoV2 PreS dTM ASO3 bivalent vaccine (D614 +B.1.351)] will be administered as two dose series at D01 and D22 in STAGE 2 Participants, by IM route<br>Control Intervention1: Placebo: 0.9% normal saline placebo will be administered as two dose series at D01 and D22 in STAGE 1 and 2 Participants, by IM route<br>→ | Efficacy: Occurrences of symptomatic COVID-19 <br/ ><br> <br/ ><br>Safety: To assess the safety of the CoV2 preS dTM-AS03 vaccines compared to placeboTimepoint: More than equals to 14 days after the second injection→ | | | | Yes | False | | |
| → | CTRI/2021/06/034449 | 7 September 2021 | CLINICAL OUTCOMES OF COVID-19 INDIAN PATIENTS AFTER
SEQUENTIAL OXYGEN THERAPY IN TERTIARY MEDICAL COLLEGE | OUR EXPERIENCE ON CLINICAL OUTCOMES OF COVID-19 INDIAN PATIENTS AFTER
SEQUENTIAL OXYGEN THERAPY IN TERTIARY MEDICAL COLLEGE | | DR DY PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE | 29-06-2021 | 20210629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57412 | Not Recruiting | No | | | | 05-07-2021 | 90 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | N/A | India→ | DR DIPANJALI MAHANTA→ | | Department of anesthesiology. DR. D.Y.PATIL MEDICAL COLLEGE HOSPITAL RESEARCH CENTRE
SANT TUKARAM NAGAR PIMPRI Department of Anesthesiology DR. D.Y.PATIL MEDICAL COLLEGE HOSPITAL RESEARCH CENTRE
SANT TUKARAM NAGAR PIMPRI→ | hhnarkhede@gmail.com→ | 9820120440→ | Dr. D.Y Patil Medical College, Hospital And Research Centre, Pune→ | Inclusion criteria: 1. Patients diagnosed with COVID-19 <br/ ><br>2. Including Diabetes mellitus, Hypertension <br/ ><br>3. Willing to sign consent form voluntarily.→ | Exclusion criteria: 1)Pregnant,Cognitive and Mental disorder <br/ ><br>2)Any known lung pathology like active tuberculosis,Bronchial asthma, <br/ ><br>Bronchiectasis, Pulmonary embolism, Chronic respiratory failure and other <br/ ><br>serious respiratory disorder <br/ ><br>3)Cigarette smokers <br/ ><br>4)Obese patients.(BMIâ?¥30) <br/ ><br>5)Cardiovascular,Cerebrovascular and hepato-renal disease. <br/ ><br>6)Elderly, Immunocompromised and Carcinoma patients.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: HFNO (High flow nasal<br>oxygenation) device: Covid 19 pneumonia cases with SpO2 80-90% and respiratory rate 30-40/min on admission will be started on oxygen therapy using HFNO device<br>Control Intervention1: Non-rebreather reservoir bag mask: Covid 19 <br>pneumonia cases with SpO2â?¥90% and respiratory rate30/min on admission<br>will be started on oxygen therapy using non-rebreather reservoir bag mask.<br><br>Control Intervention2: Non Invasive Ventilation (NIV): Covid 19 pneumonia cases with SpO2 80% and respiratory rate 40/min on admission will be started on oxygen therapy using NIV mask<br>→ | Escalation of oxygen requirement on 5th,10th and 15th day in each oxygen therapyTimepoint: Escalation of oxygen requirement after 1 week and 2 weeks of treatment in each oxygen therapy→ | | | | Yes | False | | |
| → | CTRI/2021/06/034452 | 7 September 2021 | Taking care of health care workers during the COVID-19 pandemic | Taking care of health care workers during the COVID-19 pandemic:
feedback from COVID warriors | | PGIMER Chandigarh | 29-06-2021 | 20210629 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57277 | Not Recruiting | No | | | | 05-07-2021 | 609 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Usha Dutta→ | | Department of gastroenterology,
PGIMER, Chandigarh Sector 12, Chandigarh
pin - 160012→ | ushadutta@gmail.com→ | 8198877022→ | PGIMER, Chandigarh→ | Inclusion criteria: All working hospital staff willing to fill the data form.→ | Exclusion criteria: All hospital staff not willing to fill the form.→ | | Intervention1: Not applicable: Not applicable<br>→ | Feedback of health care workersTimepoint: once at time of filling survey form→ | | | | Yes | False | | |
| → | CTRI/2021/06/034469 | 7 September 2021 | Cardiac Effects In Moderate To
Severe COVID-19 Patients Receiving Treatment In
Critical Care Unit Of A Tertiary Care Hospital,
West Bengal | Cardiovascular Manifestation In Moderate To
Severe COVID-19 Patients Undergoing Treatment In
Critical Care Unit Of A Tertiary Care Hospital,
West Bengal And Role Of Portable, Point Of Care
Cardiac Biomarker Autoanalyzer In Their Early
Diagnosis. | | MEDICAL COLLEGE KOLKATA | 30-06-2021 | 20210630 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56489 | Not Recruiting | No | | | | 01-07-2021 | 150 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | ASIM KUMAR KUNDU→ | | Medical College Hospitals
Green Building
3rd Floor 88 College Street
Kolkata
700073→ | drkunduasim@gmail.com→ | 8910112128→ | Medical College Kolkata→ | Inclusion criteria: Laboratory confirmed COVID-19 patients <br/ ><br>SpO2 <94% <br/ ><br>Patients on different modalities of oxygen therapy <br/ ><br>Patients with radiologically confirmed pneumonia <br/ ><br>Suffering from ARDS / Acute Respiratory Failure→ | Exclusion criteria: Patients unwilling to participate in the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Discharge from CCU <br/ ><br>All cause mortalityTimepoint: 28 days→ | | | | Yes | False | | |
| → | CTRI/2021/06/034470 | 7 September 2021 | Medical device clinical trial on Covid 19 patients. | An Open Label, Proof of Concept, Single Center, Comparative Study of a Non-Invasive Breath Sampling Device for providing samples useful in the diagnosis of COVID-19. | | StanwixForbes LLC | 30-06-2021 | 20210630 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57468 | Recruiting | No | | | | 07-07-2021 | 40 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 2 | India→ | Andrew Ganesh→ | | No 71 Balaji Nagar
S N R College Road Opp sriram Complex Avarampalyam Coiambatore
→ | AndrewG@stanwixforbes.com→ | | StanwixForbes LLC→ | Inclusion criteria: 1. Patients of either sex, 18 to 75 years of age (both inclusive). <br/ ><br>2. Patients with clinical symptoms of SARS-CoV-2. <br/ ><br>3. Willing to come for follow â??up visit. <br/ ><br>4. Able to give written informed consent <br/ ><br>→ | Exclusion criteria: 1. Volunteers who are in ICU or unconscious or unable to give breath samples. <br/ ><br>2. History of having received or participated in any other similar clinical trial in the last 24 hrs or currently ongoing. <br/ ><br>3. Any condition that in the opinion of the investigator does not justify the patientâ??s inclusion for the study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Not Applicable: Not Applicable<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | 1. % difference in the positivity or negativity of the COVID-19 results between invasive and non-invasive sample testing/ diagnosis. <br/ ><br>2. % difference in the viral load of the COVID-19 samples between invasive and non-invasive breath sample testing/ diagnosis using RT-PCR method. <br/ ><br>Timepoint: Day 0 and Day 7 or <br/ ><br>Date of discharge→ | | | | Yes | False | | |
| → | CTRI/2021/06/034471 | 7 September 2021 | Patient satisfaction at Siddha COVID care centres | Patient satisfaction survey at Siddha COVID-19 Care Centers in Tamil Nadu, India, 2021- A cross sectional study | | Central Council for Research in Siddha | 30-06-2021 | 20210630 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57500 | Not Recruiting | No | | | | 06-07-2021 | 480 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | S Natarajan→ | | Siddha Central Research Institute
Central Council for Research in Siddha
Arumbakkam → | drnatarajan78@gmail.com→ | | Siddha Central Research Institute→ | Inclusion criteria: laboratory-confirmed COVID-19 patients admitted and managed in Siddha CCC, Tamil Nadu, from May-July, 2021.→ | Exclusion criteria: 1.Those who were admitted in SCCC and discharged/referred out/discharged AMA before 24 hours from the time of admission <br/ ><br>2.Those who are hospitalized at the time of interview and not able to respond <br/ ><br>3.Those who are not in a position to converse and respond <br/ ><br>4.Those who does not know to speak Tamil/ English <br/ ><br>5.Those who are not willing to participate <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | understand the status of facility and the service of Siddha CCCTimepoint: 2 months→ | | | | Yes | False | | |
| → | CTRI/2021/06/034472 | 7 September 2021 | To study the clinical and echocardiographic profile of late cardiac sequel of covid -19: | Spectrum of late cardiac sequel of covid -19: a 3 month clinical and echocardiographic follow up study | | Dr Ambudhar Sharma | 30-06-2021 | 20210630 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55817 | Recruiting | No | | | | 09-07-2021 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ambudhar Sharma→ | | Room NO 107 1st Floor Superspeciality Block DR. RPGMC Tanda Kangra Dr RPGMC Tanda Kangra→ | ambudhar414@gmail.com→ | 9418048268→ | DR. RPGMC TANDA KANGRA→ | Inclusion criteria: Age more than 18 year of age <br/ ><br>Covid 19 patients discharged at least 3 month back <br/ ><br>→ | Exclusion criteria: Failure to give consent <br/ ><br>Inability to produce discharge slip <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | to determine the late effects on ventricular systolic and diastolic function of covid 19Timepoint: 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/06/034493 | 7 September 2021 | Retrospective and prospective observational on Indian population recieved Covid 19 vaccination in India | A Retrospective and Prospective Observational, Non-interventional Longitudinal study to Evaluate the Long-term Safety and Effectiveness of all available vaccines which are approved by Indian Regulatory against Covid-19 in India. | | Invotree Foundation | 30-06-2021 | 20210630 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57514 | Recruiting | No | | | | 12-07-2021 | 30000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | D Kavita Pingale→ | | B-7/1,Kothari Compound-27 Acres,Nr Tiku-ji-ni wadi Resort ,Chitalsar,Manapada B-7/1,Kothari Compound-27 Acres,Nr Tiku-ji-ni wadi Resort , Chitalsar,Manapada→ | kavita.pingale@innvoceptsolutions.com→ | 7680074619→ | Innvocept Global Solutions Pvt Limited→ | Inclusion criteria: 1. Healthy participants or participants with co-morbidities or subjects recovered covid infection and who have completed at least one dose of vaccination from available vaccines in India and complete final dose of vaccination by December 2021. from <br/ ><br>2. Study participants willing to sign data sharing consent. <br/ ><br>3. Study participants willing to provide data for minimum or at least six months from previous dose of vaccination <br/ ><br>→ | Exclusion criteria: 1. Subjects who are not vaccinated. <br/ ><br>2. Subjects who are vaccinated but not willing to consent for data sharing <br/ ><br>→ | | Intervention1: Nil: Nil<br>→ | 1. Number of Adverse events / TEAEs (Treatment emergent adverse events) post vaccinationï? Timepoint: Every Month from Previous dose of vaccine untill 12 months→ | | | | Yes | False | | |
| → | CTRI/2021/06/034496 | 7 September 2021 | Enhancing protective action of COVID-19 vaccine by using Ashwagandha | A study of Ashwagandha co-administration with COVID-19 vaccine (COVISHIELDTM) on safety, immunogenicity, and protection: A randomized, double blind, placebo controlled, multi-centric clinical trial - AYUSH-AG-VAC-01 | | CCRAS Ministry Of Ayush | 30-06-2021 | 20210630 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57187 | Not Recruiting | No | | | | 02-07-2021 | 1200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Dr N Srikanth→ | | CCRAS New Delhi→ | bpatwardhan@gmail.com→ | 09689766399→ | Savitribai Phule Pune University→ | Inclusion criteria: 1. Apparently healthy adults of either sex aged 18-45 years <br/ ><br>2. SARS-COV-2 RT-PCR negative volunteers, eligible for vaccination as determined by medical history and physical examination <br/ ><br>3. Written informed consent by participants <br/ ><br>4. The participant willing to comply with study protocol requirements <br/ ><br>5. Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration. or should be classified as non-childbearing potential (defined as surgically sterile or post-menopausal). Women in the child bearing potential shall continue adequate contraception (Barrier or hormonal) through the duration of the study. <br/ ><br>→ | Exclusion criteria: 1. Any known co-morbidity or acute illness with or without symptoms at the time of study vaccine administration <br/ ><br>2. Participants who had a history of COVID -19 any time in the past or currently positive for SARS-CoV-2 by RT-PCR <br/ ><br>3. History of any known hypersensitivity to any vaccine or any component of study material (Vaccine or Ashwagandha). <br/ ><br>4. Any confirmed or suspected condition with impaired/altered function of immune system or possible risk suggested by investigations (e.g. increased levels of D-dimer) <br/ ><br>5. Women who are breast-feeding and pregnant <br/ ><br>6. Individuals who are using any intervention (AYUSH or other interventions) for prophylaxis or for immune boosting or that may influence immune system e.g. steroids, methotrexate, anti-rheumatoid agents, drugs from AYUSH systems within 30 days prior to screening <br/ ><br>7. Individuals who have received systemic immunoglobulins or blood products within 3 months prior to screening <br/ ><br>8. Any contraindication of COVISHIELDTM vaccine <br/ ><br>→ | | Intervention1: Ashwagandha and COVISHIELD Vaccine: Ashwagandha Tablet 500mg (aqueous extract equivalent to 4 grams Ashwagandha root powder) twice daily For 24 Weeks<br>COVISHIELDTM will be administered as per the 2- dose schedule on Day 1 and at the end of 12 weeks as 0.5 ml dose intramuscularly as per the national guideline<br>Control Intervention1: Placebo and COVISHIELD Vaccine: Placebo tablet [containing Starch (35%), Calcium carbonate (35%), and Microcrystalline<br>cellulose Powder (30%)] 500 mg twice daily for 24 weeks<br><br>→ | Immunogenicity as measured by SARS-CoV-2 spike (S1) and RBD-specific IgG antibody titresTimepoint: Baseline (Day1),4 weeks, 8 weeks, 12 weeks,16 weeks, 24 weeks and 28 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/07/034506 | 7 September 2021 | Siddha COVID care centre facility survey | Situation analysis of Siddha COVID-19 care centres, Tamil Nadu, India, 2021 | | Directorate of Indian Medicine and Homeopathy | 01-07-2021 | 20210701 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57503 | Not Recruiting | No | | | | 05-07-2021 | 54 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | C Anbarasi→ | | Anna Hospital Campus
Arumbakkam → | dranbu1208@gmail.com→ | | Central Council for Research in Siddha→ | Inclusion criteria: patients and Health workers in Siddha Covid care centre→ | Exclusion criteria: not willing to participate in the survey→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | to document the status of functioning of Siddha Covid Care Centres in terms of best practices and its implementationTimepoint: 2 months→ | | | | Yes | False | | |
| → | CTRI/2021/07/034520 | 7 September 2021 | Clinical Evaluation of Tab. AOIM â?? Z in managing after-effects of COVID â?? 19 infection | Evaluation of Clinical Efficacy of Tab. AOIM â?? Z in managing after-effects of COVID â?? 19 infection â?? An Open Labelled, Single Arm, Prospective, Exploratory Clinical Study | | Shree Dhootapapeshwar Limited | 02-07-2021 | 20210702 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57644 | Not Recruiting | No | | | | 10-07-2021 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Mahesh Kumar Harit→ | | Dept of Basic Principles, D. Y. Patil Deemed to be University School
of Ayurveda, Nerul, Navi Mumbai → | drvedvati@gmail.com→ | 9594830100→ | D. Y. Patil deemed to be University School of Ayurveda, Nerul, Navi Mumbai→ | Inclusion criteria: Male or Female participants between the age group of 18 to 60 years (both inclusive), Participants with history of positive RT-PCR (Not less than 2 weeks to rule out active infection),Participants who are ready to provide written informed consent and who are ready to voluntarily participate and abide to the protocol requirements→ | Exclusion criteria: Pregnant and Lactating females, Participants hospitalized or in institutional quarantine, Participants having any medical or surgical condition that would require immediate medical or surgical intervention at the time of screening, Participants having immune compromised status like HIV, Hepatitis, Tuberculosis and Cancer etc., Participants taking steroid treatment and or any kind of immunosuppressive therapy, Participants participating in any other clinical study or having participated in any other study 3 months prior to screening in the present study, Other conditions, which in the opinion of the investigators makes the subject unsuitable for enrolment or could interfere in adherence to of the study protocol→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Tab. AOIM-Z: one tablet orally twice a day followed by Water (lukewarm water if possible) - for 90 days<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | a) Improvement in symptoms of Post COVID-19- such as Cough, Fatigue, Shortness of breath, Chest pain, Anxiety and olfactory and gustatory dysfunction <br/ ><br>b) Improvement in Respiratory Function (FVC & FEV1) <br/ ><br>c) Improvement in CRP levels <br/ ><br>d) Improvement in SpO2 (sitting & after 6-min walk test) <br/ ><br>e) Improvement in distance covered in 6-min walk testTimepoint: Day 0, Day 45, Day 90→ | | | | Yes | False | | |
| → | CTRI/2021/07/034521 | 7 September 2021 | to study impact of yog nidra and music therapy on sleep quality, mental health and global well being of recently recovered hospitalised covid-19 patients | To study the impact of Yog nidra and music therapy on the sleep quality, mental health and global well being of the population recently recovered from COVID-19: A Randomised controlled trial | | AIIMS RISHIKESH | 02-07-2021 | 20210702 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57516 | Not Recruiting | No | | | | 25-07-2021 | 90 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Investigator Blinded | N/A | India→ | MONIKA PATHANIA→ | | DEPARTMENT OF GENERAL MEDICINE, LEVEL 6 AIIMS RISHIKESH, UTTARAKHAND → | anshupathania27@gmail.com→ | 8126021556→ | AIIMS RISHIKESH→ | Inclusion criteria: â?? 40 years to 60 years of age both genders <br/ ><br>â?? History of being covid positive who have been recovered and discharged from Aiims Rishikesh with more than 5 days of hospitalisation within 6 months duration. <br/ ><br>â?? Patient with PSQI more than 5, who wellbeing index less than 40. <br/ ><br>â?? Participants who are having smartphone, internet connection and zoom application. <br/ ><br>â?? Willing to commit to regular yog nidra and music therapy sessions at home <br/ ><br>→ | Exclusion criteria: â?? Pregnant women <br/ ><br>â?? Patients unable to understand instructions. <br/ ><br>â?? Patients not willing to attend more than 75 percent of sessions <br/ ><br>→ | Health Condition 1: B338- Other specified viral diseases
→ | Intervention1: To compare the effect of yog nidra and music therapy on the sleep quality, mental health and global wellbeing of the patients recovered from covid-19.: Participant recruitment will be done using consecutive sampling method, at the respective OPD aiims, Rishikesh. Eligible participants will be allocated to three arms (ratio 1:1:1) with the help of computer generated randomized sequence. The random allocation sequence will be generated by a third person with no clinical involvement ensuring unpredictable allocation sequence. All the participants will be randomised and the allocated group will be given in a concealed fashion sequentially numbered opaque sealed envelopes (snose). Envelopes will contain a small sheet of aluminium foil in order to make them impermeable to intense/immense light. Envelopes will be opened sequentially and only after writing participantâ??s name and other details in order to remove any chance of selection bias. <br>All the participants will be divided in 3 groups. All subjects in first group will receive yog nidra, in the second group will receive music therapy(mt) sessions and third group will get placebo only. <br> yog nidra- the online version of yog nidra will be delivered by at least one certified volunteer of SSIAR, with at least one back up teacher at all times. The online version of yog nidra for all the participants has a total duration of 30 minutes every day for 30 days total. These sessions will be given via zoom application. There will not be any funds involved in this.<br> music therapy (mt)- online music therapy sessions will be provided by a certified volunteer from SSIAR. Participants will be given 30 min of music therapy session daily for a period of 30 days total. There will not be any funds involved in this. All→ | Primary outcome for this study will be compare the impact on mental health, sleep quality and global wellbeing between all 3 groupsTimepoint: 30 days→ | | | | Yes | False | | |
| → | CTRI/2021/07/034522 | 7 September 2021 | A clinical trial to study the effects of DWRX2003 (Niclosamide IM Depot Injection) in COVID-19 patients | An Open label, Multi-center, Single arm, Phase I Study to Evaluate the Safety, Tolerability, Pharmacodynamics (PD) and Efficacy of DWRX2003 (Niclosamide IM Depot Injection) following Intramuscular Administration in COVID-19 Patients | | Daewoong Pharmaceutical India Pvt Ltd | 02-07-2021 | 20210702 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57038 | Not Recruiting | No | | | | 30-07-2021 | 16 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 1 | India→ | Lakshmikanth Maddela→ | | Plot No.5A, APIIC, IE, Prashanth Nagar, Kukatpally → | lakshmikanthm@daewoong.co.kr→ | 04044668800→ | Daewoong Pharmaceutical (India) Pvt. Ltd.→ | Inclusion criteria: 1.Over 18 years of age, inclusive, at time of signing the Informed Consent Form (ICF) <br/ ><br>2.Patients who confirm COVID-19 positive by Reverse Transcriptase Polymerase Chain Reaction (RT-PCR) assay a week prior to randomization. <br/ ><br>3. Clinical signs of pneumonia (fever, cough, dyspnea, fast breathing) or Imaging diagnosis of pneumonia plus one of the following: <br/ ><br>- Respiratory rate â?¥24 breaths/min, or; <br/ ><br>- Respiratory distress, or; <br/ ><br>- SpO2 < 94% on room air <br/ ><br>4. Patients who agree to give written informed consent and are willing to participate in the study. <br/ ><br>5. Patients who are hospitalized or admitted to the hospital or who are planned to be. <br/ ><br>6. Patients who will be available for the entire study period and is capable of understanding and communicating with the investigators and clinical study facility staff. <br/ ><br>7. Female patients who are having negative results in serum pregnancy test during screening, and urine pregnancy test at randomization <br/ ><br>8. Female patients of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 60 days after their dose of study treatment (Preferably two methods). <br/ ><br>9. Male patient and/or Female patientâ??s partner must agree to use condoms or should have undergone vasectomy or spermicide in addition to female contraception for additional protection against conception for 60 days after their dose of study treatment (Preferably two methods). <br/ ><br>→ | Exclusion criteria: 1. Patients with critical medical conditions such as: <br/ ><br>A. Acute Respiratory Distress Syndrome (ARDS) <br/ ><br>B. Patient who is currently in an urgent crisis where invasive mechanical ventilation and/or extracorporeal membrane oxygenation (ECMO) is needed. <br/ ><br>C. Evidence of sepsis, septic shock or multiple organ dysfunction/failure. <br/ ><br>2. Patients receiving systemic corticosteroids within 15 days prior to screening <br/ ><br>3. Patient who is positive or reactive for antibodies to HIV 1 and 2, hepatitis B & C, and Rapid Plasma Reagin (RPR) <br/ ><br>4. Patient who is suspected to be positive for any respiratory tract viral/bacterial infection, or active tuberculosis within 14 days prior to screening. <br/ ><br>5. Patient who was vaccinated (COVID-19 vaccine) prior to screening <br/ ><br>6. Patients receiving or who have received antiviral therapy and anti- retroviral therapy within 28 days prior to screening visit, except patients who had stopped antiviral therapy for enough wash out period <br/ ><br>7. Patient with uncontrolled respiratory disease other than COVID-19 pneumonia (i.e. Chronic Obstructive Pulmonary Disease, asthma, cystic fibrosis, etc.) <br/ ><br>8. Patients with a history of uncontrolled congestive heart failure (New York Heart Association Classification of 3rd, and 4th grade), angina, myocardial infarction, cerebrovascular events, Coronary artery bypass graft (CABG), transient ischemic attack, or pulmonary embolism within 3 months to the administration of the investigational product. <br/ ><br>9. Hypersensitivity to the investigational product and/or its component or emergency drugs for hypersensitivity (e.g. epinephrine). <br/ ><br>10. Patient being treated for malignancy <br/ ><br>11. Patient who has participated in any other clinical trial within 30 days prior to screening. <br/ ><br>12. Patient who continuously requires immunosuppressants (i.e. Anti-TNFα inhibitors, interleukin inhibitors, any other immunosuppressants warranted after organ transplantation) <br/ ><br>13. Patient who have blood clot disorders or bleeding tendency. <br/ ><br>14. At screening, Creatinine clearance < 30 mL/min, or Estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73ã?¡ (by Cockcroft-Gault equation) <br/ ><br>15. At screening, Aspartate transferase (AST) or Alanine transferase (ALT) > 5x upper limit of normal <br/ ><br> <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: DWRX2003: Dose and dosage frequency: 960 mg divided into two consecutive doses on Day 1 (480 mg, intramuscular left deltoid) and Day 2 (480 mg, right deltoid)<br>Route of administration: Intramuscular (IM injection)<br>Formulation: 240 mg/ 1 ml<br>Duration of the treatment: 31 days (including window period, 28 days excluding window period)<br>Control Intervention1: NIL: NIL<br>→ | The primary objective of this study is to assess the safety, tolerability, pharmacodynamics (PD), and efficacy of Niclosamide injectable (DWRX2003) following multiple doses of DWRX2003 in moderate to severe COVID-19 patients.Timepoint: From Baseline to End of treatment→ | | | | Yes | False | | |
| → | CTRI/2021/07/034525 | 7 September 2021 | Anaesthesia management of post covid patients during surgery who are affected with mucormycosis involving nose, eyes and brain | Perioperative management of patients with post Covid rhino-orbito-cerebral mucormycosis â?? Prospective observational Study | | Government Medical College Vadodara | 02-07-2021 | 20210702 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57429 | Not Recruiting | No | | | | 12-07-2021 | 150 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Devyani Desai→ | | Department of Anaesthesiology,
Ssg Hospital,
Vadodara. → | devyani.dr@gmail.com→ | 9909983168→ | Government medical college, Vadodara.→ | Inclusion criteria: 1) Age Group â?? 18 to 70 years of age <br/ ><br>2) Either Gender. <br/ ><br>3) ASA â?? I/II/III/IV <br/ ><br>4) Previous h/o Covid (confirmed case by either +ve RTPCR test or by CT scan) <br/ ><br>5) Patients with confirmed diagnosis of rhino-orbito-cerebral mucormycosis on biopsy, and requiring surgical intervention→ | Exclusion criteria: Nil→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: nil: nil<br>→ | To observe the post anaesthesia recovery status of the patients.Timepoint: From time of extubation till 24 hours.→ | | | | Yes | False | | |
| → | CTRI/2021/07/034543 | 7 September 2021 | Study of application of amphotericin into the nose for prevention of fungal infection in COVID positive patients | Topical amphotericin via intranasal route in covid positive patients at risk for invasive fungal sinusitis | | Department of ENT | 02-07-2021 | 20210702 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57060 | Not Recruiting | No | | | | 15-07-2021 | 246 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Investigator Blinded | Phase 4 | India→ | Dr Pratibha C B→ | | Department of ENT, St Johnâ??s Medical College and Hospital
Koramangala, Bangalore-34, Karnataka. India
→ | cb.pratibha@gmail.com→ | 9986075682→ | St Johns Medical College Hospital→ | Inclusion criteria: - pre-existing diabetes mellitus at the time of admission <br/ ><br>- in those without diagnosed diabetes at baseline, a fasting or random blood glucose level > 200 mg/ dl at any time point during admission <br/ ><br>- patients who have received â?¥6 mg/day of Dexamethasone or â?¥30mg/day of methylprednisolone <br/ ><br>- patients receiving immunomodulators for at least 24 hours <br/ ><br>- patients receiving systemic anti-bacterial drugs <br/ ><br>- patients with hematologic malignancies <br/ ><br>- receiving bone marrow transplant/ systemic chemotherapy/ HIV-AIDS/ immunosuppressive therapy after organ transplant <br/ ><br>→ | Exclusion criteria: 1. COVID 19 patients with evidence of mucor mycosis at screening or randomization <br/ ><br>2. COVID 19patients with features of invasive fungal sinusitis at screening or randomization <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: standard care and amphotericin B: Standard of care+ Intervention- Intranasal amphotericin B preparation, Patient advised to instil dilute amphotericin nasal drops into both nostrils 3 times/ day for 14 days from day of randomization. Standard of care: All patients affected with COVID-19 illness are classified and treated according to hospital protocol derived from NIH guidelines, CDC guidelines, NICE guidelines, American Society of Haematology guidelines. The co morbidities especially hyperglycaemia is treated according to hospital guidelines given by department of General Medicine.<br>Control Intervention1: standard of care and placebo: placebo- Saline nasal drops, Patient will be advised to instil saline nasal drops into both nostrils three times a day for 14 days from the day of randomization<br>→ | Proportion of COVID positive patients at risk for invasive fungal sinusitis developing mucor mycosisTimepoint: 14 days→ | | | | Yes | False | | |
| → | CTRI/2021/07/034549 | 7 September 2021 | Comparison in change of oxygen saturation and cardiovascular parameters in recently diagnosed COVID-19 patients undergoing master two step exercise stress test and six minute walk test | Comparison of master two step exercise stress test versus six minute walk test in patients tested positive for SARS-CoV-2 and coming to the PGIMER emergency unit for medical consultation. | | Amol N Patil | 02-07-2021 | 20210702 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57473 | Not Recruiting | No | | | | 05-07-2021 | 80 | Interventional | Randomized, Crossover Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ankit Kumar→ | | DM RESIDENT Department of Pharmacology PGIMER Sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012 India DM RESIDENT Department of Pharmacology PGIMER Sector 12 Chandigarh
Chandigarh
CHANDIGARH
160012 India→ | seeamol83@gmail.com→ | 9990245973→ | PGIMER Chandigarh→ | Inclusion criteria: Inclusion criteria: <br/ ><br>1. SpO2 > 93% <br/ ><br>2. Respiratory Rate < 24/min <br/ ><br>3. RT-PCR Covid Positivity within four days of study enrolment <br/ ><br>→ | Exclusion criteria: Exclusion criteria: <br/ ><br>1.SpO2 < 92% <br/ ><br>2.Respiratory Rate >24/min <br/ ><br>1.Age > 60 years <br/ ><br>2.Cardiovascular disease, Hypertension and CAD <br/ ><br>3.Chronic lung/kidney/liver disease <br/ ><br>4.Cerebrovascular disease <br/ ><br>5.Obesity with BMI > 30 <br/ ><br>6.Locomotor disability <br/ ><br>7.Visual disability <6/60 in better eye with correcting lenses <br/ ><br>8.Cognitive disability or Altered sensorium <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Master 2 step test: After assuring half an hour rest on a sitting chair, the subject is asked to stand in front of wooden block of two steps on either side for one minute. Two 9-inch steps are used. The number of trips are calculated as per the patientâ??s physical capacity. These trips are to be completed in 1½ minutes.Patient is evaluated before and after for hear tate, respiratory rate, oxygen saturation, leg fatigue, dyspnoea.<br>Control Intervention1: 6 minute walk test: 1.The primary outcome to be reported is 6MWD (distance covered in 6 minutes). <br>2.The number of laps and any additional distance covered (the number of metres or feet in the final partial lap) should be recorded. <br>3.The total distance walked is calculated, rounding to the nearest metre or foot.<br>4.If the patient stopped during the test, the total time stopped, the number of stops and the average walking speed over the 6 min are also reported [111]. <br>5.In patients who cannot walk for 6 min, this may provide alternative metrics for detecting change over time [111] and may facilitate exercise prescription [112]. <br>6.It is optional to report the 6MWD as a percentage of predicted. <br>7.If the % predicted 6MWD is reported, the reference equations used should be stated.<br>8.Continuous Sp02, Lowest SpO2, end-test HR and symptom scores obtained before and after the test should also be reported. <br>9.Change in SpO2 is a prognostic marker and is more variable in people with lung disease.<br><br>→ | 1. To compare the accuracy of the master two step test against the six minute walk test (6MWT) in detecting exercise-induced oxygen desaturation in newly diagnosed RT-PCR positive COVID patients.Timepoint: baseline, within 1 hour (immediate after the test)→ | | | | Yes | False | | |
| → | CTRI/2021/07/034587 | 7 September 2021 | Admission of patients to intensive care unit after vaccination for covid or noncovid illenss and to study their clinical charactristics | : To study the demographics and clinical characteristics of patients requiring Intensive care admission post COVID vaccination for COVID or Non Covid illnesses and their outcome, A Multicentre study,(PostCoVac Study) Retrospective Design - PostCOVac Study | | Dr Amarja Ashok Havaldar | 05-07-2021 | 20210705 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55230 | Recruiting | No | | | | 10-07-2021 | 770 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Amarja Ashok Havaldar→ | | Department of Critical Care medicine St Johns Hospital Bangalore
KARNATAKA → | amarjahavaldar@rediffmail.com→ | 9036082112→ | St Johns Medical college→ | Inclusion criteria: 1.Patientâ??s admitted in ICU post vaccination either after first or second dose of vaccine will be included.→ | Exclusion criteria: Patients who have not taken the vaccine will be excluded.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: I00-I99- Diseases of the circulatory system
→ | | Broadly dividing patients into two groups. COVID or nonCovid illness. <br/ ><br>1. Covid illness To evaluate the severity of Covid infection of patients admitted post vaccination and the effect on ICU mortality. <br/ ><br>2. Noncovid illness â?? To identify what type of nonCovid illnesses patients developed post vaccination requiring Intensive care admission.and also to look for any thromboembolic phenomenon. And its effect on ICU mortality. <br/ ><br> <br/ ><br>Timepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/07/034588 | 7 September 2021 | Study to evaluate the efficacy and safety of Molnupiravir capsules when administered along with Standard of Care compared to Standard of Care alone in Indian patients with mild COVID-19 disease | A Phase 3 Prospective Open Label, Randomized Multicenter Parallel Study to evaluate the efficacy and safety of Molnupiravir capsules when administered along with Standard of Care compared to Standard of Care alone in Indian patients with mild COVID-19 disease | | Aurobindo Pharma Limited | 05-07-2021 | 20210705 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57387 | Not Recruiting | No | | | | 10-07-2021 | 1220 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 3 | India→ | Dr Subhra Lahiri→ | | AXIS Clinicals Ltd
1-121/1 Miyapu
AXIS Clinicals Ltd
1-121/1 Miyapur Hyderabad500049
Telangana INDIA
→ | Subhra.L@axisclinicals.com→ | 8886221089→ | AXIS Clinicals Ltd→ | Inclusion criteria: 1.Male and/or female patients aged â?¥ 18 and â?¤ 60 years of age (both inclusive). <br/ ><br>2.Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent. <br/ ><br>3.Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization. <br/ ><br>4.Patients with uncomplicated upper respiratory tract symptoms may have one of the symptoms of fever, cough, sore throat, nasal congestion, malaise, headache or any other signs and COVID-19 symptoms without any evidence of breathlessness or hypoxia (normal saturation) within 5 days prior to the randomization. <br/ ><br>5.Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on). <br/ ><br>6.Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit. <br/ ><br>7.Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization. <br/ ><br>Medically acceptable forms of contraceptive include: <br/ ><br>a.Hormonal contraceptives (at least 1 month before screening visit) <br/ ><br>b.Double barrier methods (e.g., diaphragm with spermicide; or condoms with spermicide) <br/ ><br>c.Intrauterine device (IUD) <br/ ><br>→ | Exclusion criteria: 1.Patients with known hypersensitivity to any of the excipients of the study medication or to any other similar class of drugs. <br/ ><br>2.Patients who participated in any other clinical trial of an experimental treatment for COVID-19 within 90 days prior to randomization. <br/ ><br>3.Patients infected post vaccination of either 1st or 2nd dose. <br/ ><br>4.Patients with one of the following symptoms at the time of screening. <br/ ><br>a. Respiratory rate â?¥ 24/min, breathlessness <br/ ><br>b. SpO2: â?¤ 93% on room air <br/ ><br>5.Patients with pulse rate < 50 beats per minute at rest at the time of screening and randomization <br/ ><br>6.Patients are currently hospitalized or expected to need hospitalization for COVID-19 within 48 hours of randomization. <br/ ><br>7.Patients have hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3X upper limit of normal at screening. <br/ ><br>8.Patients with platelet count <100,000/μL or received a platelet transfusion within 5 days prior to randomization. <br/ ><br>9.Patients with AIDS-defining illness in the past 6 months. <br/ ><br>10.Patients with uncontrolled co-morbid conditions such as hypertension, diabetes, cardiovascular disease, chronic lung/ liver/ kidney disease, cerebro-vascular disease as per the investigatorâ??s discretion. <br/ ><br>11.Patients currently administering or anticipated to require Favipiravir, Oseltamivir or any other anti-viral treatments during study participation. <br/ ><br>12. Patients with Absolute Neutrophil Count (ANC) < 500 mm3. <br/ ><br>13.Patients currently administering immunosuppressive treatments within 30 days of prior to randomization or systemic corticosteroids. <br/ ><br>14.Female patients who are pregnant and/ or breast feeding. <br/ ><br>15.Patients who have any medical condition(s) or has any medical condition(s) which would likely interfere with the conduct or interpretation of the study as per the investigatorâ??s discretion <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Molnupiravir: Molnupiravir pluse standard of care and standard of care alone As per ICMR.<br>Duration of Treatment : 5 days oral twice daily (800mg)<br>Control Intervention1: Standard of care therapy: standard of care therapy will be given to the subjects as per the institution practice<br><br>Duration of Treatment : 5days<br>→ | Rate of hospitalization of patients from randomization up to Day 14. <br/ ><br>Hospitalization is defined as hospital admission for more than 24 hours with respiratory rate â?¥ 24/ minute and SpO2â?¤93% in room air requiring oxygen supplementation.Timepoint: Rate of hospitalization of patients from randomization up to Day 14. <br/ ><br>Hospitalization is defined as hospital admission for more than 24 hours with respiratory rate â?¥ 24/ minute and SpO2â?¤93% in room air requiring oxygen supplementation.→ | | | | Yes | False | | |
| → | CTRI/2021/07/034589 | 7 September 2021 | Mucormycosis(fungal infection) patients with and without COVID-19 | A Multcenter, Case-control study on Mucormycosis in COVID-19 and Non COVID-19 patients in India (MUCOVIvi-2 Study-India) - MUCOVI-2 | | World health Organization India Office | 05-07-2021 | 20210705 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57378 | Not Recruiting | No | | | | 21-07-2022 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Arunaloke Chakrabarti→ | | Department of Medical Microbiology, PGIMER, Chandigarh → | arunaloke@hotmail.com→ | | Post Graduate Institute of Medical Education and Research→ | Inclusion criteria: All consecutive confirmed and probable (probable only for pulmonary or disseminated disease) mucormycosis cases diagnosed during the study period will be enrolled (both COVID-19 related and unrelated). Additionally, for each COVID-19 associated mucormycosis (CAM), we will include two age- (± 5 years) and sex-matched cases of COVID-19 cases without mucormycosis as controls. <br/ ><br>A diagnosis of mucormycosis will be made in subjects with a compatible clinical and radiological presentation and the demonstration of fungi in the tissue (or sterile body fluids) by either direct microscopy (broad ribbon-like aseptate hyphae) or isolation of Mucorales. Patients will be classified as â??provenâ?? mucormycosis, defined by the presence of aseptate hyphae in the biopsied sample from deep tissue or isolation of Mucorales from sterile sites. â??Probableâ?? pulmonary or disseminated mucormycosis will be defined based on the host risk factors (both classical and putative), radiological findings, and demonstration of the fungi by either culture or cytology from any site. A diagnosis of COVID-19 will be made in subjects positive for SARS-CoV-2 RNA in respiratory specimens by reverse transcription-polymerase chain reaction (RT-PCR) or a positive rapid antigen test. CAM will be defined as the occurrence of proven or probable mucormycosis (up to 3 months) in COVID-19 subjects. <br/ ><br>→ | Exclusion criteria: Patients with endemic mycoses (histoplasmosis, sporotrichosis, <br/ ><br>penicilliosis), yeast infections, and allergic fungal diseases like <br/ ><br>allergic bronchopulmonary aspergillosis will not be included.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To describe the patient and agents (fungi) characteristics for mucormycosis among COVID-and non-COVID associated cases in India. <br/ ><br>â?¢ To evaluate the risk factors for infection with Mucorales in patients confirmed with COVID-19 in the studied population. <br/ ><br>â?¢ To study the treatment practices and the outcomes of the patients with mucormycosis. <br/ ><br>Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/07/034603 | 7 September 2021 | D dimer as a marker to assess severity of covid 19 pneumonia | D dimer as a marker in assessing the severity of covid as implicated radiologically | | Columbia Asia referral hospital yeshwantpur | 05-07-2021 | 20210705 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50986 | Not Recruiting | No | | | | 10-07-2021 | 237 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Abdul majeed→ | | Room no 201,General Medicine Department doctors room,2C division,2nd floor,Columbia Asia Referral Hospital,Yeshwantpur Brigade Gateway,Near Orion mall,Yeshwantpur→ | abdul.m@columbiaindiahospitals.com→ | 09731019030→ | Columbia Asia referral hospital→ | Inclusion criteria: All inpatients admitted with Covid 19 pneumonia in Columbia asia referral hospital yeshwantpur→ | Exclusion criteria: All hypercoagulable states excluded. <br/ ><br>Previous cases of pulmonary embolism, DVT,liver disease,renal disease,active somekrs,cardiac failure,connective tissue diseases,post op cases excluded.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J128- Other viral pneumonia
→ | | To establish D dimer as an important predictor of severity of covid 19pneumoniaTimepoint: At admission,3 days,1 week,1 month→ | | | | Yes | False | | |
| → | CTRI/2021/07/034604 | 7 September 2021 | Preoperative clinical profile and perioperative anaesthetic events in a recently recovered COVID-19 patients undergoing surgery for mucormycosis: a prospective, observational study | Correlation between preoperative clinical profile and perioperative anaesthetic events in a recently recovered COVID-19 patients undergoing surgery for murcormycosis: a prospective,observational study | | Lok Nayak Hospital | 05-07-2021 | 20210705 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57502 | Not Recruiting | No | | | | 09-07-2021 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sonia Wadhawan→ | | Department of Anaesthesiology and Intensive care
Room No 302 third floor
BL Taneja Block
Maulana Azad Medical College
New Delhi → | soniawadhawan@hotmail.com→ | 9810946845→ | Maulana Azad Medical College→ | Inclusion criteria: 1.Post COVID 19 adult patients <br/ ><br>2.Requiring urgent surgical debridement for mucormycosis→ | Exclusion criteria: Patients in acute stages of COVID 19 illness→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B465- Mucormycosis, unspecified
→ | | Occurrence of intraoperative anaesthesia related events and postoperative complicationsTimepoint: from day of surgery to 7 days after surgery→ | | | | Yes | False | | |
| → | CTRI/2021/07/034605 | 7 September 2021 | Normal Saline Nasal Wash and Gargle for COVID-19 | Effect of Normal Saline Nasal Spray and Gargle (NSNSG) on oxygen dependent COVID-19 patients. - NSNSG | | Department of Health and Family WelfareGovernment of West Bengal India | 05-07-2021 | 20210705 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57708 | Recruiting | No | | | | 10-07-2021 | 150 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | UDAY SANKAR CHATTERJEE→ | | Office of Superintendant, M.R. Bangur Hospital, Tollygunge, Kolkata 700033, India. Dept. of Pediatric Surgery, Park Clinic; 4, Gorky Terrace, Kolkata, 700017, India→ | udaysankarchatterjee@yahoo.com→ | 9831017686→ | PARK MEDICAL RESEARCH AND WELFARE SOCIETY→ | Inclusion criteria: 1. People aged more than 18 years irrespective of gender. <br/ ><br>2. Sp02 level below 90% on admission, however can perform NSNSG produre. <br/ ><br>→ | Exclusion criteria: 1. In ability / refuse to do the procedure. <br/ ><br>2. Patient having SpO2 level below 90% but clinically unstable and/or disoriented. <br/ ><br>3. Patient on high flow nasal cannula (HFNC) or other more invasive method. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J09X- Influenza due to identified novelinfluenza A virus
Health Condition 3: J22- Unspecified acute lower respiratory infection
→ | Intervention1: Normal Saline Nasal Spray and Gargle: Procedures to be done: <br>a. Normal Saline Nasal Spray and Gargle (NSNSG) for one minute per nostril; till the saline water comes out through opposite nostril and gargle with saline water for one minute would be started as early as admission along with monitoring of oxygen inhalation. <br>b. NSNSG three hourly would be continued for five days in intervention group. <br>c. Repeat collection of blood for CRP (C-reactive protein), NLR (neutrophil lymphocyte ratio), Total count, RT-PCR and HRCT lung for severity score after five days / seven days in both groups.<br>d. Monitoring of other biochemical, radiological parameters as per standard protocol would also be continued both in control and in study group. <br>e. Follow up the CPSMS process for severity score.<br><br>Control Intervention1: CONTROL: No NSNSG; they would be treated with conventional treatment protocol. However, biochemical tests and HRCT chest would be done on admission and after five days, similar to intervention group.<br>→ | A. Diminution of oxygen requirement. <br/ ><br>B. Improvement in severity score in HRCT lung compared to control group. <br/ ><br> <br/ ><br> <br/ ><br>Timepoint: 5-6days <br/ ><br> <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/07/034606 | 7 September 2021 | Study to know role of Ayurveda medicines in Preventing COVID-19 infections | A clinical study to evaluate the role of Ayurveda medicines in Preventing COVID-19 infections | | Sree Ramachandra Health services Pvt Ltd | 05-07-2021 | 20210705 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57785 | Not Recruiting | No | | | | 12-07-2021 | 5000 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 4 | India→ | DrMRavi Kumar Reddy→ | | 21st KM, UdayapuraKanakapura Main Road → | ramheart@gmail.com→ | 9949033315→ | Sree Ramachandra Health Services Pvt Ltd→ | Inclusion criteria: 1.People not vaccinated with any COVID Vaccine at the time of enrolment in the trial. <br/ ><br>2.Age limit â?? 18 to 45 years, both Male & Female <br/ ><br>3.Patients willing to give their consent to participate in the clinical trial <br/ ><br>→ | Exclusion criteria: 1.People vaccinated with any Covid vaccine at any point of time before enrolment in the trial. <br/ ><br>2.People with PCR proven Covid infections within the last 3 months <br/ ><br>3.People taking other Ayurvedic/ Siddha medicines. <br/ ><br>4.Patients with acute renal failure or Stage 4 CKD or Liver Failure (AST/ALT >5 times elevated) <br/ ><br>5.Patients on Immuno-suppression therapy <br/ ><br>6.Pregnant Women or lactating mothers <br/ ><br> <br/ ><br>→ | | Intervention1: NF 2 Ayurevdic Propreitary Medicine: Dosage: 1gm (2 tablets of 500<br>mg) thrice a day with lukewarm<br>water given half hour after<br>meals for minimum of 3 months<br>Control Intervention1: No pills: No pills will be given<br>→ | To study the effect of NF2 in the prevention of COVID-19 infectionsTimepoint: Baseline and 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/07/034608 | 7 September 2021 | A pilot study to evaluate a novel regimen of radiotherapy in post-operative patients of head and neck cancers | An essential need during the COVID pandemic: Hypofractionated adjuvant radiotherapy in resected head and neck cancers - HYPO-ART | | None | 06-07-2021 | 20210706 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57593 | Recruiting | No | | | | 09-07-2021 | 59 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 1/ Phase 2 | India→ | Deep Chakrabarti→ | | Department of Radiotherapy,
King Georges Medical University,
Shatabdi, Phase 2,
Shah Mina Road, Lucknow → | deepchakrabarti.19@gmail.com→ | 9674321201→ | King Georges Medical University→ | Inclusion criteria: 1. Patients with resected head and neck squamous cell cancers with clinical/pathological stage III or stage IV and/or with indications of adjuvant radiotherapy post-surgery <br/ ><br>2. WHO ECOG Performance Score of 2 or less. <br/ ><br>3. Patients 18 to 70 years age <br/ ><br>4. Haemoglobin > 10gm/dL, TLC > 4000/mm3 and Platelet count > 100,000/mm3. <br/ ><br>5. Normal liver, renal lung and cardiac function. <br/ ><br>6. No evidence of a second primary elsewhere in the body. <br/ ><br>→ | Exclusion criteria: 1. Cancers with histology other than squamous cell carcinoma <br/ ><br>2. Patients who are medically unfit for surgery or not willing for surgery. <br/ ><br>3. Distant metastases (Stage IVC) <br/ ><br>4. Patients with history of prior malignancy. <br/ ><br>5. Patients having received prior chemotherapy and radiotherapy to the head and neck. <br/ ><br>6. Patients having undergone surgery involving primary tumour or lymph nodes (except diagnostic biopsy) <br/ ><br>7. Patients with signs of severe ischaemic disease, severe arteriosclerosis, active coronary artery disease, cardiac arrhythmia, congestive cardiac failure, and a history of peripheral neuropathy or cerebral stroke. <br/ ><br>→ | Health Condition 1: C00-C14- Malignant neoplasms of lip, oral cavity and pharynx
→ | Intervention1: Hypofractionated adjuvant radiotherapy post-surgery in head and neck cancers: Standard conformal radiotherapy will be given at 2.5 Gy per day, 5 days per week, for 4 weeks (50 Gy in total in 20 fractions). Concurrent chemotherapy will not be given. In case of microscopically positive margins or extranodal extension, 62.5 Gy in 25 fractions over 5 weeks will be given.<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br>→ | Incidence of acute radiation-induced toxicities or complicationsTimepoint: Less than 90 days→ | | | | Yes | False | | |
| → | CTRI/2021/07/034611 | 7 September 2021 | A study to assess the safety and efficacy of a nutraceutical formulation in addition to standard of care in COVID-19 positive patients. | Single-center, double blinded, two arm placebo controlled clinical study to assess the safety and efficacy of XAR-XAP nutraceutical formulation in COVID-19 patients | | Epigeneres Biotech Pvt Ltd | 06-07-2021 | 20210706 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56607 | Not Recruiting | No | | | | 15-07-2021 | 28 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Nripen Sharma→ | | Marathon Innova, C-Wing, Office No.: 701, 7th Floor, Ganpatrao Kadam Marg, Lower Parel → | sagar@epigeneres.com→ | 9869820610→ | Epigeneres Biotech Pvt. Ltd.→ | Inclusion criteria: 1. Subjects with acute uncomplicated moderate Corona infections needing hospitalization with temperature â?¥ 38 â?? (100.4 °F); plus at least one respiratory symptom (nasal congestion, sore throat, cough, breathing difficulty {Respiratory Rate â?¥24 breaths per minute or Saturation of Oxygen (SpO2) <94% on room air}); and at least one constitutional symptom (aches or pains, fatigue, headache, chills or sweats). If antipyretics were taken, may wait at least 4 hours after dosing to determine if a qualifying temperature is observed. <br/ ><br>2. Subjects with laboratory confirmed SARS-CoV-2 infection (COVID-19) as determined by the Reverse Transcription Polymerase Chain Reaction (RT-PCR) or other approved commercially available or public health assay prior to Visit 1. <br/ ><br>3. Onset of symptoms at least 48 hours but no more than 96 hours before Visit 1 (Screening; study drug administration visit). The onset of symptoms is defined as either: <br/ ><br>3a. Time of the first increase in body temperature to â?¥ 38 â?? (100.4 °F); or <br/ ><br>3b. Time when the subject experiences at least one general or respiratory symptom. <br/ ><br>4. Subjects can have any vaccination status: not vaccinated, partially vaccinated (taken first dose), completely vaccinated (taken both doses). <br/ ><br>5. Subjects who are able to understand and willing to sign the informed consent form (ICF). <br/ ><br>6. Subjects who are willing and able to comply with all scheduled visits, treatment plans, laboratory tests, lifestyle considerations and other study procedures. <br/ ><br>7. All female subjects of child-bearing potential must have a negative urine pregnancy test result. All female subjects of child-bearing potential and male subjects and their spouse/partner must agree to use a medically acceptable method of contraception (e.g., abstinence, an intrauterine device, a double barrier method such as condom + spermicidal or condom + diaphragm with spermicidal, a contraceptive implant, an oral contraceptive or have a vasectomized partner with confirmed azoospermia) throughout the entire study period, and for 30 days for females and 90 days for males after study drug discontinuation. <br/ ><br>→ | Exclusion criteria: 1. Severe COVID-19 infection. <br/ ><br>2. History of Chronic Exposure to Smoking <br/ ><br>3. other concurrent infections requiring systemic antiviral therapy prior to screening. <br/ ><br>4. Administration of immunomodulators, interferon inducers, homeopathic, hormonal other than hormone replacement therapy, and antiviral drugs during the previous 4 weeks before the first dose. Use of corticosteroids as part of the current standard of care is permitted. <br/ ><br>6. Allergy or known allergy to components of study medication (Peanuts and Mushroom). <br/ ><br>7. Subjects with severe symptoms such as respiratory rate > 30 breaths per minute or saturation of oxygen (SpO2) < 90% on room air.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: XAR-XAP: 4 capsules of XAR-XAP thrice a day along with standard of care for 30 days<br>Route of administration: oral<br>Control Intervention1: Maltodextrin (placebo): 4 capsules of Maltodextrin thrice a day along with standard of care for 30 days<br>Route of administration: oral<br>→ | To investigate the clinical efficacy of XAR-XAP treatment in reducing the duration and severity of illness compared to placeboTimepoint: Day 0, Day 15, Day 30, Day 60, Day 90→ | | | | Yes | False | | |
| → | CTRI/2021/07/034623 | 7 September 2021 | Differential severity of COVID-19 outcomes between Indians in India and the UK | Explaining the differential severity of COVID-19 between Indians in India and the UK - DiSeCT | | Indian Institute of Public Health Bangalore Public Health Foundation of India | 06-07-2021 | 20210706 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57748 | Not Recruiting | No | | | | 01-09-2021 | 100800 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India;United Kingdom→ | Dr Giridhara Rathnaiah Babu→ | | Lifecourse Epidemiology department, Magadi Rd 1st cross, Next to leprosy hospital, SIHFW premises, Bengaluru, Karnataka → | giridhar@iiphh.org→ | 9845036197→ | Indian Institute of Public Health, Bangalore - Public Health Foundation of India→ | Inclusion criteria: 1. Participants from the MAASTHI and APCAPS cohort. <br/ ><br>2. COVID-19 positive diagnosed patients willing and able to give informed consent. <br/ ><br>3. In case of death, next of kin willing to participate <br/ ><br>→ | Exclusion criteria: 1. Participants below 18 years <br/ ><br>2. No informed consent <br/ ><br>→ | | Intervention1: NONE: NONE<br>→ | Differences in severity rates of COVID-19 between Indian populations in India compared to UK: <br/ ><br>1. in age-sex composition and epidemiological curve <br/ ><br>2. by burden of obesity, cardio-metabolic conditions or respiratory conditions <br/ ><br>3. by cross-immunity acquired from exposure to other coronaviruses or immunity acquired from tuberculosis, BCG vaccination, malaria <br/ ><br>4. Determine biological mechanisms linking severe COVID-19 to obesity, cardio-metabolic disease, respiratory conditions, immunity? <br/ ><br>Timepoint: 1.Every two months <br/ ><br>2. Post hospitalization or death <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/07/034624 | 7 September 2021 | Clinical trial of PROTECT-C hand sanitizer in SARS-CoV-2 infected subjects. | A prospective open label clinical trial to evaluate the topical viral load reduction potential of PROTECT-C hand sanitizer on SARS-CoV-2 infected subjects. - Nil | | MIYAKAWA KOGYO INDIA PVT LTD | 06-07-2021 | 20210706 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57533 | Recruiting | No | | | | 12-07-2021 | 100 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | MR SWAPNIL DIGHE→ | | 2ND FLOOR PLOT NO 18 FINAL PLOT 106 RAMTEKDI INDUSTRIAL AREA HADAPSAR PUNE 411013 → | inquiry@miyakawa.co.in→ | 8888815766→ | MIYAKAWA KOGYO INDIA PVT LTD→ | Inclusion criteria: Tested SARS- CoV-2 positive within last 8 days of study enrolment. <br/ ><br>Patients willing to sign written informed consent and are ready to comply to study procedure. <br/ ><br>SARS-CoV-2 positive asymptomatic or symptomatic patients who are under institutional quarantine/ home isolated/ hospitalized. <br/ ><br>→ | Exclusion criteria: Patients on ventilator support. Pregnant or lactating woman. Subjects with history of sun burn on hands. Subjects with history of skin disorders or on medication for the same: Eczema, Urticaria, Psoriasis, Herpes, skin cancer, Lupus, Vitiligo, Fungal infection, Candidiasis. Subjects on treatment of any degree burns. Any kind of psychiatric disorder or a condition in the opinion of the investigator may hinder communication with the research team. Inability of the subject to cooperate or communicate with the research team and provide follow up.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: PROTECT C Hand sanitizer spray<br>Stabilized chlorine dioxide solution: Spray appropriate amount of PROTECT C hand sanitizer solution on palm, rub hands together, covering entire hand, including between fingers and keep it for 90 seconds.<br>Control Intervention1: Nil: Will ask patient to cough and sneeze on palms and will take the swab for RT-PCR as a control<br>→ | Clinically significant Quantitative Reduction of <br/ ><br>80% Virus load from baseline to EOT.Timepoint: 90 sec→ | | | | Yes | False | | |
| → | CTRI/2021/07/034625 | 7 September 2021 | proof of Concept study to Assess the Safety and Immunogenicity of Abayakasthaa plus Capsules in Indian Healthy Subjects who have completed the vaccination (COVAXIN) for COVID-19 | A Randomized, Double-blind, Placebo Controlled, Parallel-Group, Proof of Concept study to Assess the Safety and Immunogenicity of AYURVEDIC Capsules in Indian Healthy Subjects who have completed the vaccination (COVAXIN) for COVID-19. - A Randomized, Double-blind, Placebo Controlled, Parallel-Group, Proof of Concept study to Assess the Safety and Immunogenicity of AYURVEDIC Capsules in Indian Healthy Subjects who have completed the v | | ACE Hospital and shripad medisearch Pvt Ltd Pune | 06-07-2021 | 20210706 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56946 | Recruiting | No | | | | 13-07-2021 | 30 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Pranjal Ausekar→ | | office No:305,309 Level-3,Nyati unitree,Nagar road,Yerwada pune.411006. office No:305,309 Level-3,Nyati unitree,Nagar road,Yerwada pune.411006.→ | sureshpatankarace@gmail.com→ | 9881256992→ | ACE Hospital - and Shripad medi-search Pvt. Ltd, Pune→ | Inclusion criteria: a) Written informed consent of a subject to participate in the trial <br/ ><br>b) Males and females aged 18+ years and 70 years <br/ ><br>c) Negative human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C test results <br/ ><br>d) Patients who has received COVAXININ 2nd dose in a last 30 to 45 days of time to be enrolled in the study. <br/ ><br>e) Negative COVID-2019 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit (72 hours prior to Visit 1 [Day 1] <br/ ><br>f) No COVID-2019 in the medical history at least 3 months prior to study participation <br/ ><br>g) History of no contact withCOVID-2019 persons within at least 14 days before the enrolment (according to subjects) <br/ ><br>h) Consent for using effective methods of contraception during the entire trial <br/ ><br>i) Negative urine pregnancy test at the screening visit (for child-bearing age women) <br/ ><br>j) No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history <br/ ><br>k) No acute infectious and/or respiratory diseases within at least 14 days before the enrollment→ | Exclusion criteria: a) Any vaccination/immunization within 30 days before the enrolment <br/ ><br>b) Steroids (except hormonal contraceptives) and immunoglobulins or other blood products therapy not finished 30 days before the enrolment <br/ ><br>c) Immunosuppressors therapy finished within 3 months before the enrolment <br/ ><br>d) Pregnancy or breast-feeding <br/ ><br>e) Acute coronary syndrome or stroke suffered less than one year before the enrolment <br/ ><br>f) Tuberculosis, chronic systemic infections <br/ ><br>g) Drug allergy (anaphylactic shock, Quincke edema, polymorphic exudative eczema, atopy, serum disease), hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study product components, acute exacerbation of allergic diseases on the enrolment day <br/ ><br>h) Subjects who are on drugs that could have potential drug interactions with adenovirus vaccine <br/ ><br>i) Medical history of malignancy <br/ ><br>j) Donated blood or plasma (450+ mL) within 2 months before the enrolment <br/ ><br>k) Splenectomy in the medical history <br/ ><br>l) Neutropenia (absolute neutrophil count less than 1,000 mm3), agranulocytosis, significant blood loss, severe anemia (hemoglobin less than 80 g/L), immunodeficiency including autoimmune disorders in the medical history within 6 months before the enrolment→ | | Intervention1: Ayurvedic Capsule: One Abayakasthaa plus capsule of 450mg twice a day for 28 days<br>Control Intervention1: Placebo: One placebo capsule 450 mg twice a day for 28 days<br>→ | 1. Change in IgG, IgA and IgM antibody levels from baseline to end of the treatment(immunogenicity) <br/ ><br>2.Change in T cells & Natural Killer (NK) cells countTimepoint: 1. Time Frame: Day 0 to Day 28]. <br/ ><br>2. Time Frame: Day 0 to Day 28].→ | | | | Yes | False | | |
| → | CTRI/2021/07/034626 | 7 September 2021 | Related to practices followed to prevent hospital aquired infections during COVID-19 | Knowledge on infection,prevention and contol measures among healthcare workers during COVID-19 | | Silpa Dey self | 06-07-2021 | 20210706 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54907 | Not Recruiting | No | | | | 10-07-2021 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Somu G→ | | Room no-25,Prasanna school of public health, Manipal University → | aurolipy@soa.ac.in→ | 9437494088→ | Siksha O Anusandhan University→ | Inclusion criteria: Doctors, Midwives, Nurses and clinical officers who are willing to be a part of this study and undestand english→ | Exclusion criteria: Who doesnt want to be a part of this study and doesnt understand english→ | | | To reduce the chance of infection,to control and follow preventive measures during coming in contact with patients during COVID-19.This will help to combat the pandemic at earliest stageTimepoint: 4weeks→ | | | | Yes | False | | |
| → | CTRI/2021/07/034662 | 7 September 2021 | perception of individuals above 45 years about COVID 19 vaccine | SAGACITY OF INDIVIDUALS MORE THAN 45 YEARS AGE, OPTING FOR COVID -19 VACCINATION | | ABVIMS DR RML Hospital | 07-07-2021 | 20210707 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57854 | Not Recruiting | No | | | | 15-07-2021 | 800 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Aanchal Kakkar→ | | Room No 301
Department of Anesthesia
ABVIMS dr RML Hospital
BABA KHARAK SINGH MARG
DELHI → | kakkaraanchal2@gmail.com→ | 9899368080→ | ABVIMS DR RML HOSPITAL→ | Inclusion criteria: INDIVIDUALS MORE THAN 45 YRS AGE COMING FOR 1ST DOSE OF VACCINATION AT ABVIMS DR RML HOSPITAL→ | Exclusion criteria: HEALTHCARE WORKERS & FRONTLINE WORKERS→ | | | WHAT IS THE PERCEPTION OF INDIVIDUALS MORE THAN 45 YEARS AGE OPTING FOR VACCINATION AT OUR HOSPITALTimepoint: 2 MONTHS→ | | | | Yes | False | | |
| → | CTRI/2021/07/034663 | 7 September 2021 | A study on immunity after Covid 19 vaccine | Observational Study on Long-term Immunogenicity of COVID-19 vaccines in vaccine-naïve seronegative and seropositive participants
| | National Centre for Biological Science | 07-07-2021 | 20210707 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57915 | Not Recruiting | No | | | | 20-07-2021 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Carolin Elizabeth George→ | | Community Health Department 4th floor, Room No:01, Asha block, Bangalore Baptist Hospital Bellary road, Hebbal, Bengaluru
Community Health Department 4th floor, Room No:01, Asha block, Bangalore Baptist Hospital Bellary road, Hebbal, Bengaluru
→ | carolinelizabethj@gmail.com→ | 9972156838→ | Bangalore Baptist Hospital→ | Inclusion criteria: - Permanent residents of the selected localities where community outreach is routine <br/ ><br>- Only one member from a household will be selected. <br/ ><br>- Either a) sero-negativity or b) sero-positivity to SARS-CoV-2 with or without a history of clinical illness suggestive of COVID-19 or confirmed COVID-19 in the past (either mild or moderate infection) <br/ ><br>→ | Exclusion criteria: - Participant failure to consent. <br/ ><br>- Pregnancy, diabetes, chronic infection such as HIV or tuberculosis and immunocompromised patients (all by history) <br/ ><br>- Acute febrile illness in the participant at the time of the survey. <br/ ><br>- Active cancers or bleeding disorders <br/ ><br>- Individuals with a history of severe COVID-19 that required ventilation or received either convalescent plasma or monoclonal antibody treatments. <br/ ><br>- Any medical condition in the participant, which, in the judgment of the investigator, would interfere with protocol adherence. <br/ ><br>→ | | Intervention1: Covishield: vaccine<br>Control Intervention1: covaxin: vaccine<br>→ | - Difference in titers and rate of increase of plasma neutralizing antibody/glycoprotein-specific antibodies post vaccination between individuals seropositive and seronegative at baseline <br/ ><br> <br/ ><br>- Magnitude of binding antibody titers (RBD/spike, nucleocapsid) post vaccination in individuals seropositive and seronegative at baseline <br/ ><br> <br/ ><br>- Seroconversion rate and duration of antibodies in individuals sero-negative at baseline <br/ ><br> <br/ ><br>Timepoint: day 42 90 180 270→ | | | | Yes | False | | |
| → | CTRI/2021/07/034664 | 7 September 2021 | Association of levels of inflammatory markers (Interleukin 6, serum ferritin and high-sensitivity C-reactive protein) with severity of illness in patients with Covid-19. | Interleukin 6, serum ferritin and high-sensitivity C-reactive protein with severity of illness in patients with Covid-19. | | Maulana Azad Medical College | 07-07-2021 | 20210707 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56491 | Not Recruiting | No | | | | 22-07-2021 | 40 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Md Khalilullah→ | | Department Of Medicine
Maulana Azad Medical College Bahadur Shah Zafar Marg
New Delhi → | bhadoriadp@hotmail.com→ | 9968604277→ | Maulana Azad Medical College→ | Inclusion criteria: Patients with Covid-19 Positive status diagnosed by either RT-PCR or Rapid Antigen Test Kit.→ | Exclusion criteria: 1. Patients on prior history of immunosuppressive therapy. <br/ ><br>2. Patients already started on steroid / Tocilizumab or any other novel immunosuppressive <br/ ><br>therapy after admission . <br/ ><br>3. Patients who already received convalescent plasma therapy. <br/ ><br>4. Patients with Pregnancy.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To estimate the association of inflammatory markers (interleukin 6 ,serum ferritin and high sensitivity c-reactive protein) levels with severity of illness in patients with covid-19.Timepoint: Less than or equals to 9 months→ | | | | Yes | False | | |
| → | CTRI/2021/07/034665 | 7 September 2021 | Perioperative outcome of Covid-19 associated Mucormycosis | Perioperative outcome of COVID-19 Associated Rhino-Occulo-Cerebral Mucormycosis: An observational study | | All India Institute of Medical Sciences Raipur | 07-07-2021 | 20210707 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57667 | Recruiting | No | | | | 06-06-2022 | 50 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Habib Md Reazaul Karim→ | | Dept of AnaesthesiaAIIMS G.E.Road TatibandhRaipur GE Road, Tatibandh, Raipur→ | drhabibkarim@gmail.com→ | 9612372585→ | All India Institute of Medical Sciences Raipur→ | Inclusion criteria: COVID-19 Associated Mucormycosis (CAM) <br/ ><br>Adults <br/ ><br>Both elective and Emergency <br/ ><br>→ | Exclusion criteria: Non-COVID-19 Associated Mucormycosis <br/ ><br>American Society of Anaesthesiologists physical class VI <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B465- Mucormycosis, unspecified
→ | Intervention1: Nil: Nil<br>→ | All Cause Morbidity and MortalityTimepoint: At baseline, day 2 postop→ | | | | Yes | False | | |
| → | CTRI/2021/07/034666 | 7 September 2021 | A survey to study the perspectives and willingness of Indian Physiotherapists to use online health services during the COVID-19 Pandemic | Perceptions and Willingness of Indian Physiotherapists to using Telehealth services during the COVID-19 Pandemic | | Sydney Roshan Rebello | 07-07-2021 | 20210707 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55540 | Recruiting | No | | | | 12-07-2021 | 176 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sydney Roshan Rebello→ | | Room 10, Ground Floor, Department of Physiotherapy, Father Muller College of Allied Health Sciences, Kankanady, Mangaluru → | sydnypt@fathermuller.in→ | 9343569219→ | Department of Physiotherapy, Father Muller College of Allied Health Sciences→ | Inclusion criteria: Qualified physiotherapists only→ | Exclusion criteria: → | | | Questionnaire sent online through Google FormsTimepoint: Baseline only→ | | | | Yes | False | | |
| → | CTRI/2021/07/034668 | 7 September 2021 | knowledge and challenges faced by transgenders for COVID 19 vaccine | community knowledge and challenges amongst the transgender population related to COVID 19 vaccines: A cross sectional study | | ABVIMS DR RML Hospital | 07-07-2021 | 20210707 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57889 | Not Recruiting | No | | | | 15-07-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DR AANCHAL KAKKAR→ | | Room No 301
Department of Anesthesia
ABVIMS Dr RML Hospital
Baba Kharak Singh MArg → | kakkaraanchal2@gmail.com→ | 09899368080→ | ABVIMS DR RML HOSPITAL→ | Inclusion criteria: transgenders above 18 years of age→ | Exclusion criteria: population other than transgenders→ | | | knowledge and challenges amongst transgenders for COVID 19 vaccineTimepoint: 1 month→ | | | | Yes | False | | |
| → | CTRI/2021/07/034669 | 7 September 2021 | To study the vaccination benefits among health care workers at a tertiary care hospital | A cross sectional study to evaluate covid vaccination effects on covid infection among health care workers of a tertiary care teaching hospital - VAD | | Sushmitha Sen C | 07-07-2021 | 20210707 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56997 | Not Recruiting | No | | | | 30-07-2021 | 100 | Interventional | Cluster Randomized Trial<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | N/A | India→ | Sushmitha Sen C→ | | Prasanna school of public health, MAHE, Manipal Prasanna school of public health, MAHE, Manipal→ | sushmithasenc@gmail.com→ | 6364615053→ | MAHE, Manipal→ | Inclusion criteria: 1.vaccinated healthcare workers like doctors, nurses, housekeeping, frontline workers who are fluent in English <br/ ><br>2. Participants who are willing to participate <br/ ><br>3. Above 18 years are included→ | Exclusion criteria: not applicable→ | | Intervention1: Covishield and covaxin Vaccine: About the completion of 2 doses (each dose contain 1.5 ml) of Covishield or covaxin vaccine through intramuscular route with the duration of covishield for 84 days and 28 days for covaxin<br>→ | To see the effect of vaccination on covid infection during second waveTimepoint: 8 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/07/034670 | 7 September 2021 | T cell test for CoVID immunity | Development of an ex-vivo assay of SARS COV-2 specific T-cell responses using an interferon gamma assay | | Yenepoya University | 07-07-2021 | 20210707 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=48925 | Not Recruiting | No | | | | 15-07-2021 | 300 | Observational | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Sonal Asthana→ | | Yenepoya (Deemed to be University)
University Road, Deralakatte 105 East End B Main
9th Block Jayanagar
Bengaluru 560069→ | sonal@transplantationliver.com→ | 9686976379→ | Yantra Health Pvt Ltd→ | Inclusion criteria: 1.Above 18 years of age <br/ ><br>2.Recent SARS COV-2 infection (recovered or active) detected by rapid antigen test or real time reverse transcription-polymerase chain reaction (RT-PCR) test for COVID-19 <br/ ><br>3.Primary contact of a SARS COV-2 patient diagnosed as above <br/ ><br>4.Patient or their surrogate is willing and able to provide written informed consent and comply with all protocol requirements <br/ ><br>→ | Exclusion criteria: 1. Below 18 years of age <br/ ><br>2. Pneumonia caused by bacteria, mycoplasma, chlamydia, legionella, fungi or other viruses <br/ ><br>3. Obstructive pneumonia induced by lung cancer or other known causes <br/ ><br>4. Significant comorbid illness likely to impact the outcome of COVID-19 including but not limited to active malignancy other than skin cancer. <br/ ><br>5. History of long-term use of immunosuppressive agents including prednisone dose >5mg daily over the 30 days prior to enrollment. <br/ ><br>6. History of severe chronic respiratory disease and requirement for long-term oxygen therapy <br/ ><br>7. Undergoing hemodialysis or peritoneal dialysis <br/ ><br>8. Estimated or actual rate of creatinine clearance < 15 ml/min <br/ ><br>9. History of moderate and severe liver disease (Child-Pugh score >12) <br/ ><br>10. History of substance abuse sufficient that the patient is unlikely to comply with testing requirements. <br/ ><br>11. History of deep venous thrombosis, pulmonary embolism, cerebral vascular disease within the last 3 years <br/ ><br>12. Known HIV, hepatitis virus, or syphilis infection <br/ ><br>13. Co-Infection of tuberculosis, influenza virus, adenovirus and other respiratory infection virus <br/ ><br>14. Moribund patient not expected to survive > 24hours <br/ ><br>15. Any condition unsuitable for the study as determined by the investigators <br/ ><br>16. Female subjects with a positive pregnancy test, breastfeeding, or planning to become pregnant/breastfeed during the study period. <br/ ><br>17. Receipt of experimental therapy for COVID-19 with the exception of convalescent plasma, dexamethasone or another corticosteroid, or remdesivir in an open label study. <br/ ><br>18. Previous or ongoing immune deficient states â?? active malignancy , undergoing chemotherapy or radiotherapy, active secondary sepsis, post-transplant , patients with immunological/ rheumatologic disorders, active HIV infection <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Clinical course of the disease, recovery , mortalityTimepoint: 2 weeks after blood draw→ | | | | Yes | False | | |
| → | CTRI/2021/07/034671 | 7 September 2021 | This Research will help us understand the effects of COVID-19 lockdown on training of athletes | Impact of the COVID-19 lockdown measures on training of elite Indian athletes: A CROSS-SECTIONAL SURVEY | | Andreya D cruze | 07-07-2021 | 20210707 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57660 | Not Recruiting | No | | | | 15-07-2021 | 359 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Andreya D cruze→ | | Department of Physiotherapy,
Manipal College of Health Professions,
Manipal Academy of Higher Education,
Manipal.
Karnataka → | prateek.srivastav@manipal.edu→ | 8971984556→ | Manipal College of Health Professions→ | Inclusion criteria: 1.Athletes participating in competitive sports for a minimum of 2 years <br/ ><br>2.Both the genders <br/ ><br>3.Athletes aged 18 years and above <br/ ><br>4. District level and above <br/ ><br>→ | Exclusion criteria: Athletes infected with COVID-19 <br/ ><br>→ | | | A self developed questionnaire will be developed and administered to the athletes through digital modes and in person <br/ ><br>Timepoint: once during the period of study. as it is a survey only a baseline assessment will be done→ | | | | Yes | False | | |
| → | CTRI/2021/07/034677 | 7 September 2021 | A multi centric study looking at the effect of covid 19 pandemic on childhood cancers | A global study looking at the impact of the Coronavirus disease (COVID-19) on the care of childhood cancers (COVIDPaedsCancer)
| | Nuffield Department of Surgical Sciences | 08-07-2021 | 20210708 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49487 | Not Recruiting | No | | | | 19-07-2021 | 1000 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | United Kingdom;Ghana;India→ | Dhruv Nath Ghosh→ | | Department of Pediatric Surgery
Christian Medical College and Hospital, Ludhiana, Punjab → | nitinjamespeters@yahoo.com→ | 9878604586→ | Department of Pediatric Surgery APC, PGIMER, Chandigarh→ | Inclusion criteria: Pediatric patients with cancers→ | Exclusion criteria: All other pediatric cancers→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
→ | | The primary objective of the study is to determine 30- and 90-day all-cause mortality rates in children with paediatric cancers during the COVID-19 pandemic across low-, middle- and high-human development index (HDI) countries. <br/ ><br>This study will examine the factors that influenced these outcomes including tumour specific data, patient-specific demographics, and changes to health system frameworks <br/ ><br>Timepoint: 30 day outcome <br/ ><br>90 dat all cause mortality→ | | | | Yes | False | | |
| → | CTRI/2021/07/034740 | 7 September 2021 | Evaluation of Immuno-Modulatory Potential of Selected Ayurvedic Formulations in Diabetic People
| Evaluation of Immuno-Modulatory Potential of Selected Ayurvedic Formulations in High Risk Quarantined Subjects and Frontline Healthcare Workers in COVID-19 Care Centre - Immunomodulator, Diabetes, | | AYUSH | 09-07-2021 | 20210709 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56556 | Not Recruiting | No | | | | 15-07-2021 | 120 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India→ | Dr Satyendra Kumar Singh→ | | Stem Cell/ Cell Culture Lab,
Department of Center For Advance Research, Stem Cell/ Cell Culture Lab,
King Georges Medical University, Chowk
Lucknow Department of Center For Advance Research, Stem Cell/ CEll Culture Lab, King Georges Medical University, Ch→ | satyendraks@kgmcindia.edu→ | 9415204356→ | King Georges Medical University→ | Inclusion criteria: i. Age â?¥18 or â?¤ 75 years at time of signing Informed Consent Form. <br/ ><br>ii. Subjects quarantined in the COVID Care centers and frontline healthcare workers. <br/ ><br>iii. Cases that have been assigned as mild or very mild cases of COVID suspect. <br/ ><br>iv. Cases presenting with fever and/or upper respiratory tract illness (Influenza like illness, ILI). <br/ ><br>v. Suspected cases, whose test reports are awaited. <br/ ><br>vi. No difficulty in swallowing oral medications. <br/ ><br>vii. Must agree not to enroll in another study of an investigational agent prior to completion of study. <br/ ><br>→ | Exclusion criteria: i. Allergies, known to be allergic to research drugs or drug excipients; <br/ ><br>ii. Subject weight is less than 40 kg <br/ ><br>iii. Cases, who test +ve for COVID-19 <br/ ><br>iv. Pneumonia with/without signs of severe disease. <br/ ><br>v. Patients being referred/admitted to Dedicated COVID Health Centers or Dedicated COVOID Hospitals. <br/ ><br>vi. Cases with ARDS or Septic shock. <br/ ><br>vii. Patients who have participated in other clinical trials within 1 month. <br/ ><br>viii. Known patients with impaired renal function (estimated creatinine clearance <60 mL / min. <br/ ><br>ix. During the screening or within 24 hours before screening, patients were found to have any of the following laboratory parameter abnormalities (based on local laboratory reference range):-ALT or AST level > 5 times the upper limit of normal range (ULN) or-ALT or AST > 3 times ULN and total bilirubin levels > 2 times ULN. <br/ ><br>x. Being pregnant or breastfeeding, or having a positive pregnancy test at the time of pre-dose inspection, or planning to become pregnant within 3 months of study treatment. <br/ ><br>→ | Health Condition 1: E119- Type 2 diabetes mellitus without complications
→ | Intervention1: Sugar Free Chyawanprash: 60 diabetic subjects will be provided 20 gm chyawanprash per day for the study duration i.e. 84 days.<br>Control Intervention1: Normal Chyawanprash: 60 healthy subjects will be provided 20 gm chyawanprash per day for the study duration i.e. 84 days.<br>→ | This study will find the role of Chyawanprash in diabetic subjects.Timepoint: We will evaluate the immunomodulatory effect of Chyawanprash by assessing given biochemical , immunological parameters at day 0, Day 21 and Day 84.→ | | | | Yes | False | | |
| → | CTRI/2021/07/034743 | 7 September 2021 | Risk factors for Mucormycosis following COVID-19 | Risk Factors of Post-COVID-19 Rhino-Orbito-Cerebral Mucormycosis in India: Case-control study, 2021 | | Dr P Manickam | 09-07-2021 | 20210709 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57948 | Not Recruiting | No | | | | 16-07-2021 | 836 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr P Manickam→ | | Division of Online Courses,
School of Public Health,
National Institute of Epidemiology,
2nd Main Road, Tamil Nadu Housing Board, Ayapakkam, Near Ambattur
Chennai → | manickam@nie.gov.in→ | 04426136415→ | ICMR-National Institute of Epidemiology→ | Inclusion criteria: Are lab confirmed ROCM patients diagnosed after 1st April 2021, Treated in/discharged from the study hospital for ROCM, Had COVID-19 prior to the diagnosis of ROCM, Hospitalised for COVID-19 care in the study hospital or elsewhere <br/ ><br>→ | Exclusion criteria: Dead, Not traceable (phone number not available/ wrong number/ no response) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B461- Rhinocerebral mucormycosis
→ | | Proportion of participants with uncontrolled diabetes mellitus during COVID-19 management <br/ ><br>Timepoint: At baseline→ | | | | Yes | False | | |
| → | CTRI/2021/07/034746 | 7 September 2021 | A study comparing Covid 19 deaths in first and second waves | Changing pattern of mortality in first and second Covid 19 waves: A comparative study from North Kerala, India | | Dr Manu Mathews | 09-07-2021 | 20210709 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57518 | Not Recruiting | No | | | | 24-07-2021 | 700 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Manu Mathews→ | | Room 406 , 4 th floor , Department of Medicine,Government Medical College, Kannur , Kerala
PIN 670503 → | manumathews123@gmail.com→ | 08156991383→ | Government Medical College Kannur,kerala→ | Inclusion criteria: All age group included , admitted in study period with laboratory confirmed COVID 19 infection and died during hospital stay→ | Exclusion criteria: Deaths definitely due to causes other than COVID 19 infection like suicides and accidents were excluded→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1) to identify and compare the age distribution of covid-19 deaths in both waves <br/ ><br>2) to estimate and compare the mean duration of illness in first and second COVID wave deaths <br/ ><br>3) To estimate the proportion of covid-19 deaths in young age group, maternal deaths ,deaths with no pre existing comorbidities among all covid-19 deaths <br/ ><br> <br/ ><br>Timepoint: Retrospective study with study period from July 1, 2020 to June 30, 2021→ | | | | Yes | False | | |
| → | CTRI/2021/07/034764 | 7 September 2021 | To find out how many are affected with COVID after vaccination in a tertiary care hospital | Clinical outcomes among vaccinated and unvaccinated COVID positive patients in a tertiary care hospital | | SIMS SRM Institutes for Medical Science | 12-07-2021 | 20210712 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57622 | Not Recruiting | No | | | | 16-07-2021 | 500 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Vedantha Srinivas→ | | Department of clinical research, b-block second floor, SIMS Hospitals, vadapalani, chennai No:1, jawaharlala nehru salai, 100 ft road, vadapalani, chennai→ | drvedantha.sj@simshospitals.com→ | 9677715361→ | SIMS (SRM Institutes for Medical Science)→ | Inclusion criteria: RT PCR confirmed cases of Covid 19 who were treated for COVID in the study setting.→ | Exclusion criteria: RT PCR negative cases→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Biochemical profile, severity and fatality of RT PCR confirmed cases of Covid 19 patients who were treated for COVID in the study setting.Timepoint: August 2021→ | | | | Yes | False | | |
| → | CTRI/2021/07/034768 | 7 September 2021 | Outcome after Tracheostomy in COVID-19 | Clinical characteristics and outcomes after tracheostomy in COVID-19: A prospective and retrospective cohort study. - Trach- COVID | | AIIMS Bhopal | 12-07-2021 | 20210712 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58080 | Not Recruiting | No | | | | 25-07-2021 | 60 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sunaina Tejpal Karna→ | | Department of Anesthesiology and Critical Care, AIIMS, Bhopal → | drtejpal@gmail.com→ | 9540946869→ | AIIMS, BHOPAL→ | Inclusion criteria: â?¢ Patients with a confirmed COVID-19 test (RTPCR/ Rapid Antigen) <br/ ><br>â?¢ Patients admitted to COVID ICU with need for intensive care and invasive mechanical ventilation <br/ ><br>â?¢ Patients who were tracheostomized <br/ ><br>→ | Exclusion criteria: â?¢ Any patient with missing data due to unavailability or misplacement of ICU Charts or admission records will be excluded.→ | Health Condition 1: J22- Unspecified acute lower respiratory infection
→ | | â?¢ To study clinical characteristics of patients who need tracheostomy in COVID-19Timepoint: 1 year→ | | | | Yes | False | | |
| → | CTRI/2021/07/034769 | 7 September 2021 | New ayurvedic formulation regime in moderate COVID-19 patients | Evaluation of new Ayurvedic formulations regime in moderate COVID 19 patients
- Regime | | Bonigi Anandaiah | 12-07-2021 | 20210712 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57346 | Not Recruiting | No | | | | 01-08-2021 | 60 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Dates of Birth or day of the Week Blinding and masking:Participant and Investigator Blinded | N/A | India→ | DrSailaja Vani B→ | | Department- AYUSH Division- Ayurveda Room no-15, 5th floor, OPD Block Esic medical college and hospital NH 65 Sanathnagar,
Hyderabad
→ | drsailajavanibatchu@gmail.com→ | 9440477048→ | ESIC Medical College and Hospital→ | Inclusion criteria: Moderate COVID- 19 confirmed participants of age > 18 years, both sexes and willing to participate with consent. <br/ ><br>WHO definition of the moderate case- Pneumonia with no signs of severe disease-Adolescent or adult with the presence of clinical features of dyspnea and or hypoxia, fever, cough, including SpO2 <94%( range 90-94%) on room air, Respiratory Rate more or equal to 24 per minute. <br/ ><br>→ | Exclusion criteria: Those who are not willing to participate, patients with severe co- morbidities such as uncontrolled Diabetes, Liver disease, Renal disorders, uncontrolled Hypertension, pregnant and lactating women and severe COVID-19. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Formula P, F & L: Three formulations of drugs being given- <br>1.Formula P<br>Main Ingredients-Arka pushpa, Jambupatra pallava, Nimbapatra pallva, Vilvapatra pallava, Devadali<br>Prakshepakas- Upakunchika, Twak, Haridra, Kankola, Karpoora, Phirangi, <br>Honey-Q/S<br>Preparation method-All medicines grind it in mixer grinder and boiled with Honey for 4 Hours.<br>Formulation administration- 1.25gm quantity 2 times per day orally on empty stomach for 3 days. <br>2. Formula F<br>Main ingredients-Haritamanjari<br>Prakshepakas- Maricha, Upakunchika, Twak, Haridra, Pippali, Jatiphala<br> Honey-Q/S<br>Preparation method-All medicines grind it in mixer grinder and boiled with Honey for 4 Hours.<br>Formulation administration - To take 1/2 hour after the use of above P Formula medicine in 2.5 gms quantity daily once orally for 3 days<br>3. Formula L<br>Main ingredients- Bhumyamalaki, Bhringaraja <br>Prakshepakas- Maricha, Upakunchika, Twak, Haridra, Pippali, Jatiphala, <br>Honey-Q/S <br>Preparation method- All medicines grind it in mixer grinder and boiled with Honey for 4 Hours.<br>Formulation administration - To take 4 hours after the use of two above P & F Formula medicines, in 2.5 gms quantity daily once orally for 3 days<br><br>Control Intervention1: Lehyam: same as the intervention agent administered.<br>→ | Primary outcome: Efficacy can be evaluated by a reduction in inflammatory markers and time (No. of days) of reduction of detectable SARS-CoV2 viral RNA in the RT PCR assays from randomization. <br/ ><br>Secondary outcome: Time from randomization and administration of medicine to recovery is expected to be lesser in the test group <br/ ><br>Timepoint: Day0 to Day 4→ | | | | Yes | False | | |
| → | CTRI/2021/07/034800 | 7 September 2021 | Perinatal COVID-19 infection and outcomes | Perinatal COVID-19 infection and outcomes: a retrospective observational study in a tertiary care hospital from Western India | | Seth GS Medical College and KEM Hospital | 13-07-2021 | 20210713 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=47244 | Not Recruiting | No | | | | 15-07-2021 | 700 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Medha Goyal→ | | 10th floor, New Building (M.S.Block)
Department of Neonatology,
KEM Hospital, Parel, Mumbai,
Maharashtra. → | drruchinanavati@gmail.com→ | 9820127317→ | Seth G.S Medical College and KEM Hospital→ | Inclusion criteria: Pregnant women with suspect COVID 19 infection admitted in Department of Obstetrics & Gynecology during the study period.→ | Exclusion criteria: none→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1.To describe the clinical profile of perinatal COVID 19 infection. <br/ ><br>2.To describe the outcomes of perinatal COVID 19 infection. <br/ ><br>Timepoint: At the time of discharge from hospital→ | | | | Yes | False | | |
| → | CTRI/2021/07/034821 | 7 September 2021 | To assess a method of lung ventilation in manner to protect them functionally during routine operation under general anesthesia about its short term and long term ill effect in patient who have recovered from covid | Comparative evaluation of intraoperative lung protective strategy in the COVID 19 recovered patients undergoing
surgery under GA to reduce short term and long term pulmonary complications Pilot study | | SGPGIMS | 13-07-2021 | 20210713 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58165 | Not Recruiting | No | | | | 20-07-2021 | 40 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant and Investigator Blinded | Phase 4 | India→ | Dr Devendra Gupta→ | | Department of Anesthesiology
Sanjay Gandhi Post Graduate Institute of Medical Sciences
Lucknow
Type 4/18 Old Campus SGPGIMS, Lucknow
→ | drdevendragpt@yahoo.com→ | 9919754895→ | SGPGIMS→ | Inclusion criteria: Patients of either sex with American Society Anaesthesiologistsâ?? physical status I-II, age between 18 and 70 years, with history of COVID 19 positive more than 3 months duration needed hospitalization and oxygen therapy during active phase) scheduled for surgery under general anaesthesia→ | Exclusion criteria: The patient with presence of active respiratory tract infection, chronic obstructive lung disease, bronchial asthma and sleep apnoea syndrome, severe cardiovascular diseases, liver or kidney dysfunction, history of second- or third-degree heart block and ischemic heart diseases, body mass index >35 kg/m2 and surgery more than 3 lumbar segments will be excluded.→ | Health Condition 1: J984- Other disorders of lung
→ | Intervention1: Group 1: Protective Lung Ventilation: Lung-protective ventilation with volume controlled mode by tidal volume of 6â??8 ml/kg/predicted<br>body weight, PEEP of 6â??8 cmH2O, a plateau pressure (pplateau) of less than 30 cmH2O, the use of recruitment<br>manoeuvres (30 cmH2O for 30 s) every 30 min (which is defined according to a modified strategy employed by Futier et<br>al. in the IMPROVE trial.<br>→ | The primary outcome will be a composite of major pulmonary and extra pulmonary complications occurring by day 7 after surgery. Major pulmonary complications will be defined as pneumonia or the need for invasive or non invasive ventilation for acute respiratory failure. Major extra pulmonary complications will be defined as sepsis, severe sepsis and septic shock (defined according to consensus criteria) or death.Timepoint: Preoperative (baseline), Day 1, Day 7 and Day 30→ | | | | Yes | False | | |
| → | CTRI/2021/07/034827 | 7 September 2021 | High dose statin for mild/moderate COVID-19 patients | High dose statin for mild/moderate COVID-19 patients: A pragmatic parallel-group open-label randomized trial with blinded endpoint assessment - COVI-TIN | | MRU RIMS Ranchi | 14-07-2021 | 20210714 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56896 | Not Recruiting | No | | | | 15-07-2021 | 616 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Centralized Blinding and masking:Outcome Assessor Blinded | Phase 2/ Phase 3 | India→ | Amit Kumar→ | | Department of Neurology → | ganeshchauhan83@gmail.com→ | | Rajendra Institute of Medical Sciences→ | Inclusion criteria: 1. Diagnosed case of COVID-19 based on RT-PCR or typical CT chest findings. <br/ ><br>Mild COVID-19: Individuals who test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test [NAAT] or an antigen test) and who have any of the various upper respiratory tract symptoms (e.g., cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and smell) with or without fever but who do not have shortness of breath or hypoxia. Sp02 on room air more than 93%. <br/ ><br> <br/ ><br>OR <br/ ><br>Moderate COVID-19: Individuals who test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test [NAAT] or an antigen test), who show evidence of lower respiratory disease during clinical assessment or imaging, and who have an oxygen saturation (SpO2) 90 â?? 93% on room air at sea level or respiratory rate of 24-30 per minute. <br/ ><br> <br/ ><br>2. Presentation within 7 days of onset of fever. <br/ ><br> <br/ ><br>3. Age 18 to 75 years <br/ ><br> <br/ ><br>4. Statin naïve patients (should not use statin for regular 15 days in last one year) <br/ ><br> <br/ ><br>5. Previously documented statin intolerance <br/ ><br> <br/ ><br>6. Unable to provide written informed consent form→ | Exclusion criteria: 1. Age < 18 years <br/ ><br> <br/ ><br>2. Severe COVID-19 pneumonia: Individuals who test positive for SARS-CoV-2 using a virologic test (i.e., a nucleic acid amplification test [NAAT] or an antigen test), who show evidence of lower respiratory disease during clinical assessment or imaging and who have SpO2 <90% on room air at sea level or respiratory frequency >30 breaths/min <br/ ><br> <br/ ><br>3. Patients already on statins for dyslipidemia or cardiovascular disorders <br/ ><br> <br/ ><br>4. Hypersensitivity to statins. <br/ ><br> <br/ ><br>5. Active liver disease or unexplained persistent elevations of serum transaminases exceeding 2.5 times <br/ ><br> <br/ ><br>6. Pregnancy and lactating mothers. <br/ ><br> <br/ ><br>7. Concomitant treatment with the immunosuppressant cyclosporine or hepatitis C antivirals glecaprevir/pibrentasvir/tipranavir/ritonavir. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | Intervention1: Atorvastatin 40mg: Atorvastatin 40mg/d for 15 days oral route along with standard treatment<br>Control Intervention1: Standard treatment: Standard treatment<br>→ | The primary outcome proportion of patients progress from mild/moderate to severe during hospitalTimepoint: at two weeks and four weeks→ | | | | Yes | False | | |
| → | CTRI/2021/07/034867 | 7 September 2021 | Incidence of bleeding in Covid-19 patients. | Incidence of Major and Clinically Relevant Non-Major Bleeding (CRNMB) Among Covid 19 pneumonia Patients Receiving Therapeutic Heparin: A Retrospective Cohort Study | | PGIMER Chandigarh | 15-07-2021 | 20210715 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58181 | Not Recruiting | No | | | | 20-07-2021 | 122 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ajay Singh→ | | Department of Anaesthesia and Intensive Care → | ajay.ydv2509@gmail.com→ | 9999276845→ | Post Graduate Institute of Medical Education & Research Chandigarh India→ | Inclusion criteria: 1.All patients with age 18 years to 65 years. <br/ ><br>2.Confirmed COVID 19 from nasopharyngeal swap by Real time Polymerase chain reaction (RT PCR) <br/ ><br>3.Patients admitted to ICU and treated with therapeutic dosage of anti-coagulants. Therapeutic anticoagulation includes patients who receive LMWH at curative dose (100 IU/kg/12 h SC based on actual weight, without exceeding 10,000 IU/12 h or UFH 500 IU/kg/24 h if creatinine clearance < 30 mL/min. <br/ ><br>→ | Exclusion criteria: a)Patients who received prophylactic dose anticoagulants. This includes patients treated with standard or reinforced prophylactic dosage of heparin (low molecular weight heparin LMWH-enoxaparinâ??up to 6000 IU/12 h SC in obese patients or unfractionated heparin UFH 200 IU/kg/24 h if creatinine clearance < 30 mL/min). <br/ ><br>b)Patients with a known bleeding disorder or evidence of active bleeding at the time of admission. <br/ ><br>c)Any contraindication to the use of Heparin. <br/ ><br>→ | Health Condition 1: J09- Influenza due to certain identified influenza viruses
→ | | The aim of the study will be to assess the incidence of major and clinically relevant nonmajor bleeding among Covid 19 pneumonia patients receiving therapeutic heparin.Timepoint: Day of Icu admission to discharge/death from ICU, could be 2-4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/07/034910 | 7 September 2021 | Effect of yoga on pulmonary function, autonomic function and stress in healthcare workers due to COVID-19 pandemic | Effect of yoga on autonomic function, pulmonary function and stress in health care workers due to COVID-19 pandemic: correlation with inflammatory and antioxidative stress markers.
| | DST SATYAM | 15-07-2021 | 20210715 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57283 | Not Recruiting | No | | | | 22-07-2021 | 105 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Dr Vivek Kumar Sharma→ | | Department of Physiology, AIIMS Rajkot, Temporary campus,opposite PMSSY building, Civil Hospital, Rajkot 360001 AIIMS Rajkot, Temporary campus, Civil Hospital→ | drviveksharma@yahoo.com→ | 9442529673→ | All India Institute of Medical Sciences, Rajkot→ | Inclusion criteria: For study group-1 subjects: Nursing Staff who consent to be administered DST SATYAM recommended standard common yoga protocol for a period of eight weeks <br/ ><br> <br/ ><br>For study group-2 subjects: Nursing Staff who consent to be administered yogic intervention of HFN meditation and slow pranayama (ANB) for a period of eight weeks and have android smart phone to download HFN meditation application. <br/ ><br> <br/ ><br>For Control Subjects: Age and gender matched healthy nursing staff who will not practice yoga Intervention <br/ ><br>→ | Exclusion criteria: For all 3 groups: Subjects, who have history of hypertension, CVD, diabetes mellitus or other endocrine disorders and those who are on medications for any acute or any chronic condition.→ | | Intervention1: HFN Meditation: yogic intervention of HFN meditation and slow pranayama-45 minutes thrice a week (ANB) for a total period of eight weeks<br>Intervention2: common yoga protocol: DST SATYAM recommended standard common yoga protocol - 45 minutes - thrice a week for a total period of eight weeks<br>Control Intervention1: Control: No yogic intervention<br>→ | Anthropometric and BP parameters <br/ ><br>AFT parameters <br/ ><br>HRV parameters <br/ ><br>PFT parameters <br/ ><br>Biochemical Parameters <br/ ><br>Timepoint: 0 <br/ ><br>8 weeks <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/07/034933 | 7 September 2021 | Blood test for endothelin as marker for severe COVID 19 related disease | To evaluate role of endothelin 1 as marker for severe COVID 19 related disease : An observational cohort pilot study | | All india Institute of Medical Science Rishikesh | 16-07-2021 | 20210716 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58366 | Not Recruiting | No | | | | 30-07-2021 | 40 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rohit Walia→ | | Room no. , Department of Cardiology , All India Institute of Medical Science , Rishikesh , Uttarakhand → | rwalia7731@yahoo.in→ | 8800492549→ | All India Institute of Medical Science Rishikesh→ | Inclusion criteria: COVID 19 cases confirmed by RTPCR <br/ ><br>Age greater than 18 years of age <br/ ><br>Informed consent→ | Exclusion criteria: Infection other than COVID <br/ ><br>Lung malignancy <br/ ><br>Chronic obstructive Pulmonary disease <br/ ><br>Chronic renal failure <br/ ><br>Malignancy <br/ ><br>Connective tissue disorders <br/ ><br>Age greater than 90 years <br/ ><br>Advanced liver disease→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B998- Other infectious disease
→ | | Correlation of serum endothelin level with severity of Lung diseaseTimepoint: Correlation of serum endothelin level with severity of Lung disease→ | | | | Yes | False | | |
| → | CTRI/2021/07/034936 | 7 September 2021 | CHEST X RAY FINDINGS IN COVID-19 PATIENTS | CHEST RADIOGRAPHIC FINDINGS IN RT-PCR POSITIVE COVID-19 PATIENTS | | yenepoya medical college | 16-07-2021 | 20210716 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56616 | Not Recruiting | No | | | | 21-07-2021 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Keerthika K→ | | Department of Radio diagnosis
Yenepoya medical college
Yenepoya university
Deralakatte, Mangalore Department of Radio diagnosis
Yenepoya medical college
Yenepoya university
Deralakatte, Mangalore→ | drvishwanathreddy@gmail.com→ | 8197410262→ | Yenepoya university→ | Inclusion criteria: Patients who are confirmed to have COVID 19 infection by real-time RT-PCR and have undergone CXR examination.→ | Exclusion criteria: Patients whose RT-PCR result is negative or inconclusive.→ | Health Condition 1: J22- Unspecified acute lower respiratory infection
→ | Control Intervention1: NIL: NIL<br>→ | describe the chest radiographic findings in RT PCR positive COVID 19 patients.Timepoint: 1 week→ | | | | Yes | False | | |
| → | CTRI/2021/07/034937 | 7 September 2021 | A clinical trial to study the efficacy and safety of Ayurveda therapy protocol in the management of Covid-19 and its Post complications | A prospective, interventional, single-arm clinical trial to evaluate the efficacy and safety of Ayurveda therapy protocol in the management of mild to moderate COVID-19 patients and its post complications | | Pankajakasthuri herbal research foundation | 16-07-2021 | 20210716 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58164 | Recruiting | No | | | | 23-07-2021 | 30 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 4 | India→ | DrJHareendran Nair→ | | Department of kayachikitsa,Room No 1, Pankajakasthuri Herbal research Foundation Pankajakasthuri
Ayurveda Medical college Kattakkada Trivandrum → | drshan@pkhil.com→ | 9188325339→ | Pankajakasthuri Herbal research Foundation→ | Inclusion criteria: 1. Patients tested positive for Covid-19 using RTPCR. <br/ ><br>2. Willing and able to provide written informed consent prior to performing study procedures by the subject or legal guardian. <br/ ><br>→ | Exclusion criteria: 1. Subject or Authorized Representative is unable to provide informed consent. <br/ ><br>2. Subject is pregnant or breastfeeding ladies. <br/ ><br>3. Subject is of childbearing potential and has a positive pregnancy test since admission to the hospital. <br/ ><br>4. Intra-thoracic or intra-abdominal surgery within the 12 hours prior to consent, or ongoing impairment of hemostasis as a result of one of these procedures. <br/ ><br>5. A history of head trauma, spinal trauma, or other acute trauma with an increased risk of bleeding. <br/ ><br>6. Cerebral Vascular Accident (CVA) or Intracerebral <br/ ><br>Arteriovenous Malformation (AVM), cerebral aneurysm, or mass <br/ ><br>lesions of the central nervous system or melena, hematemesis. <br/ ><br>7. Inability to take oral medication <br/ ><br>8. Prolonged QTc-interval in baseline ECG ( >500 ms) <br/ ><br>9. History of solid organ, allogeneic bone marrow, or stem cell transplantation. <br/ ><br>10. Severe renal failure characterized by chronic or acute need of hemodialysis, hemofiltration or peritoneal dialysis. <br/ ><br>11. Need of anticoagulants, antiplatelet agents, anti-thrombotics and thrombolytics during the treatment period. <br/ ><br>12. Participation in another research study involving an investigational agent within 30 days prior to consent. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. To evaluate the efficacy of Ayurveda treatment protocol in management of Covid-19 and PostCovid complication. <br/ ><br>2. To determine the safety of the Ayurveda treatment protocol. <br/ ><br>3. To assess the time taken for RTPCR to become negative and normalization of all clinical signTimepoint: During the therapy→ | | | | Yes | False | | |
| → | CTRI/2021/07/034938 | 7 September 2021 | Comparison of wrist based remote monitoring
device with reference standard in a tertiary care
centre for COVID19 preparedness. | Comparison of wrist based remote monitoring
device with reference standard in a tertiary care
centre: A prospective validation study for COVID19 preparedness. | | Archana A bharadwaj | 16-07-2021 | 20210716 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57452 | Not Recruiting | No | | | | 01-10-2021 | 200 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Archana A Bharadwaj→ | | Department of Anaesthesiology,
SDMCMS&H,
Manjushree Nagar,
Sattur, Dharwad -580009 SDMCMS&H,
Manjushree Nagar,
Sattur, Dharwad -580009→ | archana.a.b16@gmail.com→ | 09886468625→ | SDM College of Medical Sciences and Hospital, Shri Dharmasthala Manjunatheshwara University, Dharwad→ | Inclusion criteria: all individuals aged 12 years and above admitted at the hospital irrespective of their diagnosis→ | Exclusion criteria: Individuals with significant deformity, degenerative changes or edema of hand and wrist, localized infection, ulceration or skin breaks involving the wrist, and vascular diseases along with those who refuse consent will excluded from the study.→ | Health Condition 1: I10- Essential (primary) hypertension
Health Condition 2: J189- Pneumonia, unspecified organism
→ | Intervention1: wrist based remote monitoring device for measuring vital parameters: measurement of Blood pressure, pulse rate, oxygen saturation using wrist based remote monitoring device<br>Intervention2: NIL: NIL<br>Control Intervention1: standard NIBP monitoring device and finger pulseoximeter: measurement of Blood pressure, pulse rate and oxygen saturation using standard NIBP monitoring device and finger pulseoximeter<br>Control Intervention2: NIL: NIL<br>→ | To compare the values of vital parameters <br/ ><br>captured by GDV Ecosystem â?? Pulse Rate, Blood <br/ ><br>Pressure, Oxygen saturation in blood , with <br/ ><br>standard methods <br/ ><br>Timepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2021/07/034961 | 7 September 2021 | Perioperative
Anaesthetic Management OF Post
COVID Recovered Patients | PERIOPERATIVE
ANAESTHETIC MANAGEMENT OF POST
COVID RECOVERED PATIENTS : A multicentric study - Covid recovered | | GCS medical College Hospital and Research Centre | 19-07-2021 | 20210719 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58128 | Not Recruiting | No | | | | 26-07-2021 | 150 | Interventional | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 4 | India→ | Dr Heena Chhanwal→ | | GCS medical College Hospital and Research Centre
opp DRM office
NrChamunda bridge
Naroda Road GCS medical College Hospital and Research Centre
opp DRM office
NrChamunda bridge
Naroda Road→ | drmrshc@gmail.com→ | 9925497393→ | GCS Medical College, Hospital and Research Centre→ | Inclusion criteria: 1.Covid recovered patients posted for elective surgery upto 20 wks post covid <br/ ><br>2.Patients should be recovered from covid 19 infection , being tested positive <br/ ><br>on RTPCR report or Rapid antigen <br/ ><br>3. Adults of either gender, Age 18 to 70 years <br/ ><br>4. ASA grade I,II,III→ | Exclusion criteria: 1 Covid recovered patients posted for elective surgery greater than 20 wks post <br/ ><br>covid <br/ ><br>2. Pregnant or lactating females <br/ ><br> <br/ ><br>3. Patients with chronic neuromuscular disorders on medications→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: O- Medical and Surgical
→ | Intervention1: Perioperative anaesthetic management of post covid recovered patients: Pre operative Anaesthesia evaluation and clinical examination of recovered<br>covid patients posted for elective surgery.<br>2. To differentiate among asymptomatic and symptomatic recovered covid<br>patients in pre operative checkup.<br>3. Anaesthetic management of such asymptomatic and symptomatic recovered<br>patients according to their residual systemic effects if any.<br>Intervention2: NA: Na<br>Intervention3: Pre operative Anaesthesia evaluation: 2. To differentiate among asymptomatic and symptomatic recovered covion and clinical examination of recovered<br>covid patients posted for elective surgery.id<br>patients in pre operative checkup.<br>3. Anaesthetic management of such asymptomatic and symptomatic recovered<br>patients according to their residual systemic effects if any.<br>Control Intervention1: N.A.: N.A.<br>→ | evaluate post covid recoevered patients pre operatively by clinical <br/ ><br>examinations and laboratory investigations so that vigilant anaesthesia <br/ ><br>management of such patients can be carried out by identifying the residual <br/ ><br>effects and taking necessary interventionsTimepoint: preoperatively (Baseline), <br/ ><br>intraoperatively <br/ ><br>Postoperatively→ | | | | Yes | False | | |
| → | CTRI/2021/07/034962 | 7 September 2021 | Role of plant derived essential oils in COVID-19 patient. | Role of Phytopharmaceutical Essential Oil Blend in Asymptomatic and Symptomatic Mild Disease COVID-19 Patients: A Randomized Controlled trial | | Amol N Patil | 19-07-2021 | 20210719 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58414 | Not Recruiting | No | | | | 02-08-2021 | 110 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Alternation Blinding and masking:Open Label | Phase 1/ Phase 2 | India→ | Ankit Kumar→ | | DM RESIDENT Department of Pharmacology
PGIMER
Sector 12 Chandigarh
→ | seeamol83@gmail.com→ | 9990245973→ | PGIMER Chandigarh→ | Inclusion criteria: 1] Healthy volunteers with normal liver and kidney function, normal hemogram and ECG, urine routine, chest X-ray examination, negative urine drug screen, negative HIV, HCV, HbsAg as assessed by baseline investigations <br/ ><br>2] Age between 18 to 55 years <br/ ><br>3] Either gender <br/ ><br>4] Ready to give consent and willing to undergo experiment and comply with protocol <br/ ><br>→ | Exclusion criteria: 1. Age < 18 and > 55 years. <br/ ><br>2. Patients with moderate or severe disease. <br/ ><br>3. Pregnant and lactating population. <br/ ><br>4. Patients not giving consent for the study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Normal saline: 2 drops of Normal saline in 5 ml distilled water by nebulisation (inhalation), 4 times a day for 3 days followed by 3 times a day for next 4 days, followed by 2 times day for 7 days<br>Control Intervention1: Essential oil (EO) blend: 2 drops of Essential oil (EO) blend in 5 ml distilled water by nebulisation (inhalation), 4 times a day for 3 days followed by 3 times a day for next 4 days, followed by 2 times day for 7 days<br>→ | 1. To assess the safety and determine maximum tolerated dose of Essential oil blend nebulization by evaluating the toxicities including: type, frequency, severity, attribution and duration. <br/ ><br>2. To assess the efficacy of EOs nebulisation in preventing respiratory symptoms development in asymptomatic and mild disease COVID-19 positive patients <br/ ><br>3. To assess the efficacy of EOs nebulisation in respiratory symptom relief in mild disease COVID-19 positive patients. <br/ ><br>Timepoint: Baseline, Day 3, 5, 7, 10 and !4→ | | | | Yes | False | | |
| → | CTRI/2021/07/035013 | 7 September 2021 | Physical activity of a Child during COVID-19 pandemic.
| Physical activity of a Child during COVID-19 pandemic | | Paridhi Parin Shah | 20-07-2021 | 20210720 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58424 | Not Recruiting | No | | | | 29-07-2021 | 198 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Paridhi Parin Shah→ | | PG Classroom on Ground floor college of Physiotherapy, Sumandeep Vidyapeeth- An Institution Deemed to be University, At and post Pipariya, Taluka Waghodia District Vadodara → | shahparidhi13@gmail.com→ | 9967765527→ | College of Physiotherapy, Sumandeep Vidyapeeth→ | Inclusion criteria: Mothers of normal healthy children between 5-12 years of age→ | Exclusion criteria: 1. Children having any underlying diseases such as Cerebral Palsy, Downs Syndrome, Duchenne Muscular Dystrophy, Asthma <br/ ><br>2. Children tested positive for COVID19 <br/ ><br>3.Refusal to participate in the study→ | | Intervention1: NIL: NIL<br>→ | Questionnaire basedTimepoint: One time in research study of one year. Outcome measures will be assessed at baseline.→ | | | | Yes | False | | |
| → | CTRI/2021/07/035027 | 7 September 2021 | Efficacy of a Video Based Yoga protocol for patients recovered from Covid-19 | Efficacy of A Virtual, Video-based regular Yoga Protocol on the immune function, antioxidant status, stress hormone responses and psychological components in healthy population and patients recovered from COVID-19 in COVID pandemic Period: A randomized control trial. | | Ministry of AYUSH | 22-07-2021 | 20210722 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45509 | Not Recruiting | No | | | | 23-07-2021 | 160 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:On-site computer system Blinding and masking:Outcome Assessor Blinded | Phase 2 | India→ | Dr Ishwar V Basavaraddi→ | | Ministry of AYUSH Govt of India
68 Ashoka Road New Delhi
→ | dr.sudipdatta@gmail.com→ | 01126593705→ | All India Institute of Medical Sciences→ | Inclusion criteria: Willingness to participate in the study. <br/ ><br>Age between 20-65 years. <br/ ><br>Individuals who have Indian nationality. <br/ ><br>Access to the internet/smartphone/laptop to watch virtual video based yoga sessions. <br/ ><br>→ | Exclusion criteria: Individuals suffering from any kind of chronic diseases. <br/ ><br>Individuals with physical limitations making them unable to perform yoga asanas. <br/ ><br>Individuals with a history of alcohol abuse or smoking more than 5 cigarettes a day. <br/ ><br>Individuals taking any kind of medications. <br/ ><br>Individuals who are severely overweight (BMI > 35). <br/ ><br>Individuals working in night shifts.→ | | Intervention1: Virtual video based regular Yoga: A 45 minutes virtual yoga programme video designed by experts in the field of yoga will be administered to the recovered patients COVID 19.<br>Control Intervention1: Virtual video based regular Yoga: A 45 minutes virtual yoga programme video designed by experts in the field of yoga will be administered to the healthy individuals.<br>→ | Change in the level of multiple cytokines. <br/ ><br>Reduction in oxidative stress parameters such as malondialdehyde and F2-isoprostane. <br/ ><br>Improvement in antioxidant components such glutathione, catalase and superoxide dismutase activities. <br/ ><br>Reduction in stress hormones levels. <br/ ><br>Improvement in the scores of DASS. <br/ ><br>Timepoint: The assessment will be done at baseline (pre-intervention assessment) at 3 months and at 6 months (post intervention)→ | | | | Yes | False | | |
| → | CTRI/2021/07/035028 | 7 September 2021 | Effect of Siddha medicines in post COVID-19 patients at Sri Nallamani Siddha Covid centre, Tenkasi District, TamilNadu - A Cross Sectional Study | EFFECT OF AROKYAM KIT ( SIDDHA CONVALESCENCE MEDICINES) IN PATIENTS TREATED AT SRI NALLAMANI SIDDHA COVID CARE CENTER, TENKASI DISTRICT, TAMIL NADU - A CROSS SECTIONAL STUDY | | District collector Tenkasi | 22-07-2021 | 20210722 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51923 | Not Recruiting | No | | | | 23-07-2021 | 1409 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 2 | India→ | S Bosepriyan→ | | 37A south street thiruthiraipoondu Thiruvarur district → | chenthurvenkat@gmail.com→ | 9442180895→ | Directorate of Indian Medicine→ | Inclusion criteria: Post covid 19 convalescence treatment for the period of 15 days→ | Exclusion criteria: below 12 yrs and above 85 yrs. <br/ ><br>antenatal mothers were excluded <br/ ><br>Malignancy conditions <br/ ><br>Psychiatric groups→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Amukkura chooranam tablet each tablet 500mgs.: Two tablet, Two times a day, after food, with hot water<br>The medicine is taken for 25 days.<br>Intervention2: Nellikai legiyam: 5 grams, two times a day, with hot water.<br>The medicine is taken for 15 days<br>Control Intervention1: nil: nil<br>→ | To Prevent and reduce the post COVID 19 complicationsTimepoint: 15 days→ | | | | Yes | False | | |
| → | CTRI/2021/07/035064 | 7 September 2021 | Assessment of efficacy of antiseptic rinse on tongue decontamination in reducing the SARS CoV-2 community transfer.
| Assessment of efficacy of antiseptic rinse on tongue decontamination in reducing the SARS CoV 2 community transfer.
| | NIL | 22-07-2021 | 20210722 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58333 | Not Recruiting | No | | | | 26-07-2021 | 80 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India→ | Dr Chethana Kunthur Chidambar→ | | Sharavathi Dental College and Hospital, TH Road,Alkola, Shimoga,Karnataka-577204. → | anuhgd@gmail.com→ | 9448168733→ | Rajiv Gandhi University of Health Sciences, Bangalore→ | Inclusion criteria: 1) Patients with positive RT PCR and reported immediately after becoming symptomatic. <br/ ><br>2)Patients with positive RT PCR without any other underlying systemic illness. <br/ ><br>3)Mild symptomatic under home/quarantine center isolation. <br/ ><br>4) Age: >18 years <br/ ><br>→ | Exclusion criteria: 1)Pregnancy and lactating mothers. <br/ ><br>2)Patients with any other systemic illness <br/ ><br>3)Vaccinated with COVID 19 vaccine <br/ ><br>→ | Health Condition 1: -
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: ANTIMICROBIAL MOUTH WASHES: )To know the effectiveness of 0.5% povidone iodine in reducing the SARS <br>CoV 2 virus.<br>2) To know the effectiveness of 1.5% hydrogen peroxide in reducing SARS <br> CoV- 2 virus.<br>3)To know the effectiveness of 0.2% chlorhexidine rinse in reducing the SARS CoV-2 virus.<br><br>Control Intervention1: MOUTH WASHES: Comparing the effectiveness of 0.5% povidone idodine,1.5% hydrogen peroxide, 0.2% chlorhexidine and saline /water rinse with each other in reducing SARS CoV-2.<br><br><br>→ | Effectiveness Of 0.2% Chlorhexidine, 0.5% Povidone iodine, 1.5% hydrogen peroxide mouth rinse on SARS CoV-2 community transfer.Timepoint: At the baseline, one week, end of second week.→ | | | | Yes | False | | |
| → | CTRI/2021/07/035068 | 7 September 2021 | Investigating Determinants of COVID-19 outcomes amongst South Asians in India and U.K | Prospective investigation of the determinants for COVID-19 outcomes amongst South Asians in India and the United Kingdom. A [LOLIPOP100K / iHealth-T2D / GHRU] substudy. - COV-Ind-UK | | Department of Biotechnology | 23-07-2021 | 20210723 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57612 | Recruiting | No | | | | 26-07-2021 | 30000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | United Kingdom;India→ | Dr R M Anjana→ | | Department of Diabetology Madras Diabetes Research
Foundation No 4 Conran Smith Road Gopalapuram Chennai Tamil Nadu → | sujeet.jha@maxhealthcare.com→ | 9910609000→ | Max Superspeciality Hospital A Unit Of Devi Devi Foundation→ | Inclusion criteria: All South Asian men and women who are already participants of our existing population cohorts (LOLIPOP, iHealth-T2D, and GHRU surveillance studies) will be eligible to take part in this research. All study participants are >18 years old and have consented to recontact for research as part of enrolment to the respective population study.→ | Exclusion criteria: Participants who have currently acute illness, or who are unable to provide consent will be excluded from the study.→ | | | To determine the incidence of COVID-19 amongst participants of our established prospective population studies in India and the UK through serological testing, and linkage to electronic health registries. <br/ ><br>Timepoint: 12 months→ | | | | Yes | False | | |
| → | CTRI/2021/07/035070 | 7 September 2021 | A study of ensovibep (MP0420) in ambulatory adult patients with symptoms of COVID-19 | A randomized, double-blind, placebo-controlled, multicenter study of ensovibep (MP0420) in ambulatory adult patients with symptomatic COVID-19 | | Molecular Partners AG | 23-07-2021 | 20210723 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58365 | Not Recruiting | No | | | | 30-07-2021 | 400 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 2/ Phase 3 | Brazil;Czech Republic;Hungary;India;Indonesia;Kenya;Netherlands;Poland;South Africa;United States of America→ | Suneela Thatte→ | | Unit No. 902, 9th Floor, B Wing, Supreme Business Park, Hiranandani Gardens, Powai, Mumbai → | suneela.thatte@iqvia.com→ | 9820131694→ | IQVIA RDS (India) Private Limited→ | Inclusion criteria: Patients eligible for inclusion in this study must meet all the following criteria: <br/ ><br>1. Men or women â?¥ 18 years of age on the day of inclusion (no upper limit). <br/ ><br>2. Presence of two or more of the following COVID-19 symptoms with an onset within 7 days of dosing: Feeling hot or feverish, cough, sore throat, low energy, or tiredness, headache, muscle or body aches, chills or shivering, and shortness of breath. <br/ ><br>3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid antigen test). <br/ ><br>4. Understand and agree to comply with the planned study procedures. <br/ ><br>5. The patient or legally authorized representative give signed informed consent. <br/ ><br>→ | Exclusion criteria: Patients meeting any of the following criteria are not eligible for inclusion in this study. <br/ ><br>1. Requiring hospitalization at time of screening, or at time of study drug administration. <br/ ><br>2. Oxygen saturation (SpO2) â?¤ 93% on room air at sea level or ratio of arterial oxygen partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) < 300, respiratory rate â?¥ 30 per minute, and heart rate â?¥ 125 per minute. <br/ ><br>In India, patients with a respiratory rate â?¥ 24 per minute or with an oxygen saturation â?¤ 93% on room air (SpO2) are not eligible. <br/ ><br>3. Known allergies to any of the components used in the formulation of the ensovibep or placebo. <br/ ><br>4. Suspected or proven serious, active bacterial, fungal, viral, or other infection (besides SARS-CoV-2) that in the opinion of the investigator could constitute a risk when taking intervention. <br/ ><br>5. Any serious concomitant systemic disease, condition or disorder that, in the opinion of the investigator, should preclude participation in this study. <br/ ><br>6. Any co-morbidity requiring surgery within 7 days of dosing, or that is considered life-threatening within 29 days of dosing. <br/ ><br>7. Prior or concurrent use of any medication for treatment of COVID-19, including antiviral agents, convalescent serum, or anti-viral antibodies. Purely symptomatic therapies (e.g., over-the-counter [OTC] cough medications, acetaminophen, and nonsteroidal antiinflammatory drugs [NSAIDs]) are permitted. Prior vaccination for COVID-19 is permitted. <br/ ><br>8. Are concurrently enrolled or were enrolled within the last 30 days or within 5 half-lives (whichever is longer) in any other type of medical research judged not to be scientifically or medically compatible with this study. <br/ ><br>9. Are pregnant or breast feeding. <br/ ><br>10. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception at the time of dosing and for 11 weeks after dosing of study drug. Highly effective contraception methods include: <br/ ><br>a. Total abstinence (when this is in line with the preferred and usual lifestyle of the patient). Periodic abstinence (i.e., calendar, ovulation, symptothermal, and postovulation methods) and withdrawal are not acceptable methods of contraception. <br/ ><br>b.Female sterilization (have had bilateral surgical oophorectomy [with or without hysterectomy], total hysterectomy, or bilateral tubal ligation at least 6 weeks before taking study treatment). In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow-up hormone level assessment. <br/ ><br>c. Male sterilization (at least 6 months prior to screening). The vasectomized male partner should be the sole partner for that patient. <br/ ><br>d. use of oral, injected or implanted hormonal methods of contraception or placement of an IUD or IUS or other forms of hormonal contraception that have comparable efficacy (failure rate 1%) for example hormone vaginal ring or transdermal hormone contraception. In case of use of oral contraception, women should have been stable on the same pill for a minimum of 3 months before taking study treatment. <br/ ><br>if local regulations deviate from the contraception methods listed above to prevent pregnancy, local regulations apply and will be described in the informed consent form. <br/ ><br>Comorbidities defining clinically vulnerable patients (with→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Part A: <br>ensovibep: Route: Intravenous<br>Dose: 10 mL vials are used containing 15 mg/mL ensovibep provided in isotonic buffer matrix.<br>Patients in Part A will be assigned on Day 1 at Visit 1 to one of the following 4 treatment arms in a ratio of 1:1:1:1 and will be dosed accordingly: <br>â?¢ Ensovibep 75 mg â?¢ Ensovibep 225 mg â?¢ Ensovibep 600 mg â?¢ Placebo<br>Placebo: Isotonic saline will be used as placebo<br><br>Intervention2: Part B: ensovibep: Route: Intravenous<br>Dose: 5 mL vials are used containing15 mg/mL ensovibep provided in isotonic buffer matrix.<br>Patients in Part B will be assigned on Day 1 at Visit 1 to one of the following 2 treatment arms in a ratio of 1:1<br>â?¢ Ensovibep (optimal safe and efficacious dose, selected in Part A) â?¢ Placebo<br>Placebo: placebo consisting of the formulation buffer.<br><br>Control Intervention1: NA: NA<br>→ | Part Aâ?¢To assess the effect of ensovibep, compared to placebo, in reducing SARS-CoV-2 viral load through Day 8. <br/ ><br> <br/ ><br>Part B â?¢ To demonstrate superiority of ensovibep, compared to placebo, in reducing the occurrence of hospitalizations (â?¥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29Timepoint: Part A Endpoint: Time-weighted change from baseline (measured at Day 3, Day 5, and Day 8) in log10 SARS-CoV-2 viral load in nasopharyngeal swabs through Day 8. <br/ ><br> <br/ ><br>Part B Endpoint: Proportion of patients experiencing hospitalizations (â?¥ 24 hours of acute care) and/or emergency room visits related to COVID-19 or death from any cause up to Day 29→ | | | | Yes | False | | |
| → | CTRI/2021/07/035092 | 7 September 2021 | Abnormalities in functions of thyroid gland in COVID-19 patients | Thyroid Dysfunction In Patients Of COVID-19 | | Maulana Azad Medical College | 23-07-2021 | 20210723 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57890 | Not Recruiting | No | | | | 01-08-2021 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ban Anuj Achyut→ | | Department of Medicine, BL Taneja Block, Maulana Azad Medical College, Bahadur Shah Zafar Marg → | sumeetsingla555@gmail.com→ | | Maulana Azad Medical College, New Delhi→ | Inclusion criteria: Confirmed COVID-19 cases (Positive for SARS-CoV-2 by RT-PCR or Rapid Antigen Test)→ | Exclusion criteria: 1. Patients who are diagnosed with hyperthyroidism or hypothyroidism and currently on treatment for the same <br/ ><br>2. Patients with past history of thyroid disorder or have received treatment for the same <br/ ><br>3. Patients with history of thyroid cancer or surgery <br/ ><br>4. Patients receiving drugs affecting thyroid function like amiodarone, lithium, etc. <br/ ><br>5. Patients who have received cancer chemotherapy or radiotherapy in the last 6 months <br/ ><br>6. Patients who have recently received iodinated contrast media. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Proportion of COVID-19 patients having various thyroid abnormalities viz. hypothyroidism, thyrotoxicosis, Gravesâ?? disease, Hashimotoâ??s thyroiditis, sub-acute thyroiditis and sick euthyroid syndrome during admissionTimepoint: At the end of the study→ | | | | Yes | False | | |
| → | CTRI/2021/07/035093 | 7 September 2021 | Epimorph COVID Acute Respiratory Distress Syndrome | Epidural Morphine in COVID ARDS patients with abnormally high respiratory drive: a double-blind, randomized controlled trial - EpimorphCARDS | | Swagata Tripathy | 23-07-2021 | 20210723 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58458 | Recruiting | No | | | | 04-08-2021 | 50 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | N/A | India→ | swagata Tripathy→ | | Dept. Anaesthesia & Critical Care
Room 406, Academic Block
AIIMS , Bhubaneswar. Sijua, Patrapada→ | tripathyswagata@gmail.com→ | 918763400534→ | AII India Institute of Medical Sciences→ | Inclusion criteria: COVID 19 ARDS patients on NIV, P/F Ration < 300 with High respiratory Drive- TFDi > 30% ( secondary - Vt > 10 ml/ kg. RR > 25 /min )→ | Exclusion criteria: Metabolic acidosis HCO3- < 16 or pH < 7.2. Severe hypoxemia warranting cessation of NIV and intubation, non-acceptance of NIV. Technical difficulty for epidural catheterization, coagulation abnormalities, low respiratory drive, EOL orders, chronic opioid use.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Epidural Morphine: Patients with High Respiratory Drive ( TFDi 30%) will be administered Epidural morphine 5 mg -10 mg in escalating doses once every 18-24 hours<br>Control Intervention1: No intervention: Control group will be positioned and draped much like intervention group but epidural catheter will not be inserted - it will be sham fixed on the back, superficially<br>→ | Diaphragm thickening index fractionTimepoint: Average of 3 readings at 3 time points each 24 hours, for the duration of minimum 48 hours and a maximum of 100 hours→ | | | | Yes | False | | |
| → | CTRI/2021/07/035109 | 7 September 2021 | Effect of covid 19 pandemic on thesis work done by postgraduate medical students | Problems in conduct of thesis work during covid 19 pandemic ( PROCON THESIS): a nation wide survey of postgraduate medical students in India - PROCON THESIS | | NONE | 26-07-2021 | 20210726 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58100 | Not Recruiting | No | | | | 27-07-2021 | 376 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Nitasha Mishra→ | | ROOM NO 7, 5TH FLOOR, HOSPITAL BUILDING, AIIMS, BHUBANESWAR → | nitsmishra@gmail.com→ | 08373938016→ | AIIMS, Bhubaneswar→ | Inclusion criteria: all postgraduate medical students of India pursuing MD MS DM Mch and DNB courses in India or faculties who are involved in their students thesis work and would like to share the problems faced by students in the thesis work→ | Exclusion criteria: unwillingness to particpate in survey→ | | Intervention1: NIL: NIL ( AS THIS IS A SURVEY)<br>Control Intervention1: NIL: NIL<br>→ | on the basis of 14 point questionnaire, we would find out what are the problems in the conduct of thesis work done by postgraduate medical students in India and impact of covid 19 pandemic on it.Timepoint: 1 WEEK of receiving the survey questinnaires→ | | | | Yes | False | | |
| → | CTRI/2021/07/035114 | 7 September 2021 | Dissociative Experiences And Fear Of Covid-19 In Patients with Obsessive Compulsive Disorder | DISSOCIATIVE EXPERIENCES AND FEAR OF COVID-19 IN PATIENTS WITH OBSESSIVE COMPULSIVE DISORDER | | Lady Hardinge Medical College | 26-07-2021 | 20210726 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50937 | Not Recruiting | No | | | | 30-07-2021 | 65 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Arnav Sharma→ | | 450 Block-B Sant Nagar Burari → | drspkhedar@gmail.com→ | 9810488067→ | Department of Psychiatry, Lady Hardinge Medical College→ | Inclusion criteria: 1. Age group: From 18-60 years. <br/ ><br>2. Patients fulfilling the DSM-5 criteria for OCD. <br/ ><br>3. Those who have studied English as a language till class 10th and can read, understand and have basic knowledge of the same. <br/ ><br>→ | Exclusion criteria: 1. Patient who is not in a state to cooperate for assessment due to acute medical or psychiatric illness <br/ ><br>2. Patients with history suggestive of intellectual disability. <br/ ><br>3. Patients having severe mental illness, which includes schizophrenia, BPAD, other psychotic disorders and other comorbidities like anxiety, depression and substance abuse. <br/ ><br>→ | Health Condition 1: F42- Obsessive-compulsive disorder
→ | Control Intervention1: nil: nil<br>→ | â?¢ Mean Scores on DES in patients with OCD. <br/ ><br>â?¢ Mean score on FCV-19S in patients with OCD. <br/ ><br>Timepoint: 1 day→ | | | | Yes | False | | |
| → | CTRI/2021/07/035117 | 7 September 2021 | Body fat and COVID 19 outcome | Body fat mass and phase angle as a predictor for COVID-19 outcome in adult patients | | Wellcome DBT India Alliance | 26-07-2021 | 20210726 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57963 | Not Recruiting | No | | | | 15-08-2021 | 436 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shalini Gajanan Hegde→ | | Department of
Physiology, St. Johnâ??s Medical College, St. Johnâ??s National
Academy of Health Sciences, Bangalore; 560034
KARNATAKA, India
→ | shal.hegde@gmail.com→ | 9914208942→ | St Johns Medical College Hospital→ | Inclusion criteria: COVID-19 Rapid antigen test/RTPCR test positive and admitted in hospital→ | Exclusion criteria: Pregnant patients or those admitted to high dependency units/intensive care units. <br/ ><br>COVID patients who are admitted in the ward but who are oedematous, on fluids, inotropes, post-surgery, on dialysis, or with clinical signs of organ failure such as chronic kidney disease. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Association of Waist circumference, Fat percentage and Phase angle with severity of COVID -19. Severity will be assessed by a composite score which includes duration of hospitalization, need for ITU/ICU stay, days of oxygen requirement, discharge/deathTimepoint: Anthropometry and outcome measures of fat percentage and phase angle will be assessed at a single time point (cross-sectional study)→ | | | | Yes | False | | |
| → | CTRI/2021/07/035143 | 7 September 2021 | A study to identify SARS-CoV2 variants and assess potential risk of their spread from COVID-19 patients infected after taking one or two doses of vaccine | Impact of COVID-19 Vaccination on Transmission Risk of Acquired Infection and Strain Characteristics | | Dr Kalpana Sriraman | 26-07-2021 | 20210726 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58023 | Recruiting | No | | | | 27-07-2021 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Nerges Mistry→ | | The Foundation for Medical Research (FMR)
Dr. Kantilal J. Sheth Memorial Building,
84-A, RG Thadani Marg, Worli, Mumbai → | kalpanasriraman@yahoo.com→ | 912224934989→ | The Foundation for Medical Research→ | Inclusion criteria: 1. Consenting COVID-19 positive individuals of age >18 years with or without vaccination <br/ ><br>2. Should not be greater than five days from onset of symptoms for COVID-19 at the time of recruitment <br/ ><br>3. Should not be greater than 48 hours from knowing positive COVID-19 diagnosis at the time of recruitment <br/ ><br>→ | Exclusion criteria: 1. Severely ill COVID-19 patients ( who have SpO2 levels less than 90% and on continuous oxygen support or ventilator support) <br/ ><br>2. Individuals who have taken mRNA vaccines, if approved by the time of study <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>→ | Transmission risk: <br/ ><br>â?¢ Proportion of vaccinated individuals expelling virus in respiratory particles compared to unvaccinated individuals <br/ ><br>â?¢ Proportion of vaccinated individuals who do not expel virus after 8 days of symptom onset <br/ ><br>Sequencing <br/ ><br>â?¢ The proportion of variants among infections occurring after initiation of vaccination compared to unvaccinated group <br/ ><br>â?¢ Identification of new mutations and variants, if any associated with breakthrough infections in Mumbai <br/ ><br>Timepoint: 1. 0-5 days of symptom onset <br/ ><br>2.8-10 days of symptom onset <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/07/035233 | 7 September 2021 | Phase 2, clinical trial to evaluate LifeViroTreat inhalation in mild COVID patient. | A Phase 2, multicentric, randomized, double blind, prospective, comparative, placebo controlled, clinical trial to evaluate efficacy and safety of LifeViroTreat inhalation in mild nCOVID-19 infected patient. - 2021-0602 | | Supreme Industries | 29-07-2021 | 20210729 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58404 | Recruiting | No | | | | 29-07-2021 | 46 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pharmacy-controlled Randomization Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | Dr Nilesh Patel→ | | R 374
MIDC TTC Industrial Area
Rabale
Navi Mumbai 1012 Dev Prime
Corporate Road
Near Vodafone House
Makarba
Ahmedabad→ | nileshp@panexcell.com→ | 02227642746→ | Panexcell Clinical Lab Pvt Ltd→ | Inclusion criteria: 1. RT-PCR positive for nCOVID-19 within last 72 hours <br/ ><br>2. Male and female patients with age above 18 years and below 65 years of age. <br/ ><br>3. Patient willing to provide informed consent to participate into the trial. <br/ ><br>4. Patient able to comply requirement of study and protocol. <br/ ><br>5. Patient having SpO2 > 94 %, Respiratory rate < 24/min and temperature < 104 °F→ | Exclusion criteria: 1 Known hypersensitivity or idiosyncratic reaction to Chlorine or any of related substance or ingredient of the formulation. <br/ ><br>2 Patient having past history of respiratory disorder like COPD, Asthma etc. <br/ ><br>3 Patient is on medication before tested nCOVID 19 positive for respiratory disease or disorder (other than viral infection). <br/ ><br>4 Patients who are diagnosed and/or on treatment for venous thromboembolism, ischemic heart disease, myocardial infarction, congestive cardiac failure, unexplained vaginal bleeding with suspicion of serious underlying condition, history of breast or cervical cancer, malignant tumor <br/ ><br>5 Patient of Hypertension and/or Diabetes who was not on stable treatment in past 3 month. <br/ ><br>6 Patient was on immunomodulatory drug <br/ ><br>7 Have participated in other clinical study related to nCOVID 19 <br/ ><br>8 Patients with other severe acute or chronic conditions that may increase the risk of participation in the study and study treatment, or may interfere with interpretation of study results, and judged by the investigator as not suitable for participation in this clinical trial. <br/ ><br>9 Known history of Chronic Kidney disease <br/ ><br>10 Known history of Chronic Liver disease <br/ ><br>11 Nursing mother or pregnant women→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: LifeViroTreat Inhalation: Group 1: LifeViroTreat Inhalation Dose: 15 min inhalation<br>Frequency: Every 4 hour<br>Duration: 3 to 5 days<br>+ Standard of Care<br>Group 2. LifeViroTreat Inhalation<br>Dose: 15 min inhalation<br>Frequency: Every 6 hour<br>Dose: 3 to 5 days<br>+ Standard of Care<br>Control Intervention1: Placebo nhalation: Group 3. Placebo inhalation <br>Dose: 15 min<br>Frequency: Every 4 hour<br>Duration: 3 to 5 days<br>+ Standard of Care<br>Group 4. Placebo Inhalation<br>Dose: 15 min<br>Frequency: Every 6 hour<br>Duration: 3 to 5 days<br>+ Standard of Care<br>→ | -Percentage of patients turning RT-PCR negative (success of treatment) at end of treatment (Day 4 or Day 6). <br/ ><br>-Percentage of patients require hospitalizationTimepoint: Day 4 <br/ ><br>Day 6→ | | | | Yes | False | | |
| → | CTRI/2021/07/035253 | 7 September 2021 | To study changes in Complete blood count and D-dimer in COVID 19 patients during second wave at tertiary care hospital, Bhavnagar | Evaluation of Complete blood count and D-dimer in COVID 19 patients during second wave at tertiary care hospital, Bhavnagar | | Government Medical College Bhavnagar | 29-07-2021 | 20210729 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57021 | Not Recruiting | No | | | | 06-08-2021 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Alpesh Goswami→ | | Hematology laboratory ,Sir T Hospital,Bhavnagar-364001
Gujarat.
→ | dralpeshgosai79@yahoo.co.in→ | 9428125028→ | Government Medical College, Bhavnagar→ | Inclusion criteria: Cases of Covid positive patients admitted in Sir T Hospital during 1st March ,2021 to 31st May,2021 whose CBC and D-dimer reports are available in pathology department. <br/ ><br>→ | Exclusion criteria: Reports for which case records are not available in medical record section <br/ ><br>→ | Health Condition 1: A00-B99- Certain infectious and parasitic diseases
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: B25-B34- Other viral diseases
→ | | Leukocytosis, <br/ ><br>neutrophilia, elevated neutrophil to lymphocyte ratio, and D-dimer are significantly increased in patients with severe and critical disease. <br/ ><br>Timepoint: 1 year→ | | | | Yes | False | | |
| → | CTRI/2021/07/035256 | 7 September 2021 | Nintedanib the game changer in COVID 19 patients | Effect of nintedanib in the prognosis of young and middle aged COVID 19 patients | | Self | 29-07-2021 | 20210729 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57898 | Not Recruiting | No | | | | 02-08-2021 | 100 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India→ | Arunkumar u→ | | Room no. 49, department of general medicine, Subbaiah institute of medical science and research center, shimoga Room no. 49, department of general medicine, Subbaiah institute of medical science and research center, shimoga→ | arunkumar1070@gmail.com→ | 9741914041→ | Subbiah institute of medical science and research center→ | Inclusion criteria: Without any comorbidities→ | Exclusion criteria: Diabetes, hypertension, IHD, CKD, immunosuppressive status, old age→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nintedanib drug trial: Nintedanib is given to COVID 19 patients and assess the prognosis and over all survival<br>Intervention2: Not applicable: Not applicable<br>Intervention3: Nintedanib: 150mg bd for 10 days<br>Intervention4: Nintedanib: 150mg bd for 10 days<br>Intervention5: Nintedanib: 150mg bd for 10 days<br>Control Intervention1: Nintedanib 150mg bd: We are using nintedanib in one set of patients and other set of patients will be considered as controls<br>→ | We are collecting the samples by taking into consideration of rtpcr positivity in covid patients and we will assess the inhospital mortality and prognosis of patients during there hospital stayTimepoint: 4 to 6 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/07/035258 | 7 September 2021 | Dental students perspective on distance learning education system due to COVID-19 pandemic | Dental Studentsâ?? perspective on distance learning at Manipal Academy of Higher Education due to COVID-19: a cross-sectional study | | NIL | 29-07-2021 | 20210729 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58850 | Not Recruiting | No | | | | 10-08-2021 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Shaswata Karmakar→ | | Department of Periodontology, Manipal College of Dental Sciences, Manipal → | dr.shaswata@gmail.com→ | 7908869061→ | Manipal College of Dental Sciences, Manipal→ | Inclusion criteria: students studying dentistry in Manipal Academy of Higher Education→ | Exclusion criteria: students who are not willing to participate in the study→ | | | Acceptance, Didactic learning, Clinical learning, MotivationTimepoint: 12 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/07/035274 | 7 September 2021 | Yoga based intervention to deal with psychological distress among family members of people involved in management of COVID- 19 | Development and evaluation of a yoga-based intervention program to deal with the psychological distress among family members of the healthcare workers engaged in the management of COVID-19 patients
- Yoga for COVID-19 distress (YOCODis) | | DST Satyam | 29-07-2021 | 20210729 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54119 | Not Recruiting | No | | | | 16-08-2021 | 80 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Dr PIyush Ranjan→ | | Room no. 10 SRB Lab Department of Medicine All India Institute of Medical Sciences Ansari Nagar → | drpiyushdost@gmail.com→ | 9268714198→ | All India Institute of Medical Sciences→ | Inclusion criteria: Family members of the healthcare workers <br/ ><br> <br/ ><br>Intend to follow up regularly will be included in the study <br/ ><br> <br/ ><br>Individuals should be able to comprehend the instructions of a structured scale <br/ ><br> <br/ ><br>Individuals who are able to read and write <br/ ><br>→ | Exclusion criteria: Patients with Known psychiatric illnesses <br/ ><br> <br/ ><br>Patients with significant psychiatric comorbidity warranting hospitalization <br/ ><br>→ | | Intervention1: Yoga with standard care: medical management if required and general counselling including dietary counseling and physical activity advice<br>Yoga-based intervention: It will include 30 minutes of yogic exercises in addition to clinical features and associated distress and a follow- up on 6 months after the intervention<br>Control Intervention1: Standard care: medical management if required and general counselling including dietary counseling and physical activity<br>→ | Improvement in mental well being as measured by DASS scoresTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/07/035295 | 7 September 2021 | Prospective registry of STEMI management in Covid era -INDIA (PRESCO-INDIA) - A Cardiological Society of India Study | Prospective registry of STEMI management in Covid era -INDIA (PRESCO-INDIA) | | Cardiological Society of India | 30-07-2021 | 20210730 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58790 | Recruiting | No | | | | 09-08-2021 | 3000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Padhinhare P Mohanan→ | | Room No - 111, Westfort Hi-Tech Hospital,Punkunnam PO, Thrissur, Kerala → | csiamistudy@gmail.com→ | 9846076006→ | Director, Westfort Hi- Tech Hospital→ | Inclusion criteria: All consecutive patients above 18 years of age with STEMI as per 4thuniversal definition of MI during the study period→ | Exclusion criteria: Patients below 18 years, <br/ ><br>Patients not willing to give informed consent, Patients with life-threatening diseases like severe COVID 19 infection on ventilator, <br/ ><br>Terminal malignancy, <br/ ><br>Debilitating stroke and CKD patients on maintenance haemodialysis, <br/ ><br>MI/PCI/CABG within past 14 days of STEMI admission, <br/ ><br>Patients thrombolysed elsewhere, <br/ ><br>Patients enrolled in any other research studies <br/ ><br>→ | Health Condition 1: I20- Angina pectoris
→ | | To study the initial treatment strategy employed for hospitalized patients with STEMI in India during the current COVID-19 pandemic and to document the differences in the primary outcome of death, re-infarction and stroke in-hospital and at 30 days post discharge based on the initial treatment strategy.Timepoint: 5 months or when target of 3000 patients are recruited which ever happens first→ | | | | Yes | False | | |
| → | CTRI/2021/07/035296 | 7 September 2021 | Role of potentised remdesvir in COVID19 hospitalised patients. | Pilot study to assess the role of potentised remdesvir in COVID19 hospitalised patients. | | Bhaarath medical college and hospital | 30-07-2021 | 20210730 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58618 | Not Recruiting | No | | | | 20-08-2021 | 30 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Baskaran Jegadish→ | | Anaesthesia department
Bhaarath medical college and Hospital.
173,Agaram main Road,Chennai
600073.
173,Agaram main road,tambaram
chennai
600073→ | sivajags@gmail.com→ | 7299911717→ | Bhaarath medical college→ | Inclusion criteria: 1. Patients over age of 18 years diagnosed with covid19 through RTPCR. <br/ ><br>2. Any adults and gender willing to give written informed consent for participation. <br/ ><br>3. Patients clinical condition mild covid19 (WHO ornidal scale 4 and below) <br/ ><br>→ | Exclusion criteria: â?¢ Patients not willing. <br/ ><br>â?¢ Paediatric age group below 18yrs. <br/ ><br>â?¢ Pregnant women <br/ ><br>â?¢ Patients with pre existing renal or liver problems. <br/ ><br>â?¢ Patients with WHO ordinal scale 5 and above for covid19 <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: potentised remdesvir !C: potentised remdesvir 1c will be given 5ml 3 times a day for one week<br>no control drug or comparator drug<br>Intervention2: no comparator agent: no comparator agent<br>Intervention3: potentised remdesvir: potentised remdesvir 1c will be given 5ml three times a day for one week<br>Control Intervention1: nil: nil<br>→ | To assess potentised remdesvir reduces the WHO ordinal scale by 2 in COVID19 hospitalised patients in 7,14,21 daysTimepoint: To assess potentised remdesvir reduces the WHO ordinal scale by 2 in COVID19 hospitalised patients in one week.→ | | | | Yes | False | | |
| → | CTRI/2021/07/035306 | 7 September 2021 | Doing intubation for non covid patients with plastic cover on a trolley with two different laryngoscopes | A Prospective Observational Comparative study to assess ease of intubation with CMAC versus Direct Laryngoscope when used for intubation with clear plastic drapes over mayo stand in covid negative patients during a pandemic in resource limited setting.
| | Dy Patil medical college hospital | 30-07-2021 | 20210730 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58266 | Not Recruiting | No | | | | 10-08-2021 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:Alternation Blinding and masking:Double Blind Double Dummy | N/A | India→ | Dr Poonam bharambe→ | | Department of Anaesthesiology
Dr. D.Y. Patil Medical College, Pimpri, Pune- 18.
→ | poonam.v.bharambe@gmail.com→ | 9702164612→ | Dr. D.Y. Patil Medical College Pimpri→ | Inclusion criteria: Age between 20 to 60 years of either gender <br/ ><br>ASA grade I and II patients <br/ ><br>Patients with MPC grade I <br/ ><br>Patients undergoing elective or emergency abdominal, obstetric, gynaecological, orthopaedic or urosurgery under general anaesthesia <br/ ><br> Patients who give informed consent and are willing to be a part of the study <br/ ><br>→ | Exclusion criteria: Age less than 20 years or more than 60 years <br/ ><br>Nasotracheal intubation <br/ ><br>ASA grade III and IV patients <br/ ><br>Patients with MPC grade III and IV <br/ ><br>Patients with difficult airway (Mouth opening less than 1.5 fingers, thyromental distance less than 6.5 cm, sternomental distance less than 12.5 cm, Neck flexion→ | Health Condition 1: O- Medical and Surgical
→ | Intervention1: Intubation: EASE OF INTUBATION WITH C- MAC WHEN USED FOR INTUBATION WITH CLEAR PLASTIC DRAPES OVER MAYO STAND less than 3hrs<br>Control Intervention1: Intubation: DIRECT LARYNGOSCOPE , WHEN USED FOR INTUBATION WITH CLEAR PLASTIC DRAPES OVER MAYO STAND<br>Duration less than 3hrs<br>→ | Time to endotracheal intubation: Time recording starts when Anaesthetist handles C-MAC laryngoscope to inflation of endotracheal tube cuff after removal of bougie. <br/ ><br>Timepoint: Time to endotracheal intubation: Time recording starts when Anaesthetist handles C-MAC laryngoscope to inflation of endotracheal tube cuff after removal of bougie. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/08/035338 | 7 September 2021 | Post vaccination immunological response and immune monitoring for SARS-CoV-2 | Evaluation of T cell immune profile and antibody response to COVID-19 vaccination - PostVacTR | | Medanta Institute of Education and Research | 02-08-2021 | 20210802 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56541 | Not Recruiting | No | | | | 09-08-2021 | 50 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Pooja Sharma→ | | 10th Floor A wing
Medanta Institute of Education and Research
Medanta The Medicity
Sector 38
Gurugram → | pooja.sharma@medanta.org→ | 9811535739→ | Medanta The Medicity→ | Inclusion criteria: Healthy adult (18-60 years) individuals receiving anti SARS CoV 2 vaccination, irrespective of their pre-vaccination serological status, providing informed consent for sampling.→ | Exclusion criteria: All individuals <18 and >60 years. <br/ ><br>Non consenting for sampling <br/ ><br>Individuals who develop COVID 19 infection during study period will be excluded from study→ | | Intervention1: NIL: NIL<br>→ | Assessment of quantitative (titer) IgG neutralizing antibody as well the generation of memory T cell responses to viral antigens will be measured in the studyTimepoint: Visit1: Blood collection and 1st dose of vaccine <br/ ><br>Visit2: Blood collection at 15th day post 1st dose of vaccine <br/ ><br>Visit3: Blood collection and 2nd dose of vaccine <br/ ><br>Visit 4: Blood collection at 15th day post 2nd dose <br/ ><br>Visit 5:Blood collection 6 month post first dose→ | | | | Yes | False | | |
| → | CTRI/2021/08/035371 | 7 September 2021 | Secondary infections among Covid 19 patients admitted to ICU | Prevalence and clinical outcomes of secondary infections associated with covid 19 in patients admitted to ICU. | | Sri Ramachandra Institute of Higher Education and Research | 03-08-2021 | 20210803 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53655 | Not Recruiting | No | | | | 16-08-2021 | 250 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Dr Baby Sailaja K→ | | Critical care Unit,
Dept of Critical care Medicine. No.1, Ramachandra Nagar, Porur.→ | sailajaroop@gmail.com→ | 9600159482→ | Sri Ramachandra Institute of Higher Education and Research→ | Inclusion criteria: All patients confirmed positive for COVID 19 disease admitted to the ICU→ | Exclusion criteria: patients tested negative for COVID 19 disease→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Prevalence of secondary infection and microbiological speciesTimepoint: after 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/08/035422 | 7 September 2021 | Vaccination against COVID19 in India : yay or nay | A nationwide survey on the epidemiology, type of vaccine and risk factors in Healthcare Workers contracting COVID-19 infection post vaccination - COVIVAC | | VMMC and Safdarjung Hospital | 04-08-2021 | 20210804 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55998 | Not Recruiting | No | | | | 09-08-2021 | 1040 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Double Blind Double Dummy | N/A | India→ | Dr Bhavya Krishna→ | | Department of anesthesia, VMMC and Safdarjung Hospital, Ansari Nagar → | drkrishnabhavya@gmail.com→ | 9810418302→ | VMMC and Safdarjung Hospital, New Delhi→ | Inclusion criteria: Healthcare workers in India who have received covaxin or covishield vaccine <br/ ><br>who are willing to participate in the survey <br/ ><br>who understand english→ | Exclusion criteria: HCWs who are not vaccinated with covaxin or covishield <br/ ><br>who are not willing to participate <br/ ><br>who do not understand english→ | | Intervention1: NIL: NIL<br>→ | 1. To estimate the incidence of COVID infection after vaccination in Health Care Workers in India <br/ ><br>2. To estimate the incidence of severe infections amongst those HCWs infected after vaccination <br/ ><br>3. To estimate hospitalisation required in severe COVID infections in HCWs after vaccinations <br/ ><br>4. To compare rate of infections between those HCWs vaccinated with Covaxin vs Covishield <br/ ><br> <br/ ><br>Timepoint: All the values will be calculated at baseline (after data collection). No follow up will be done.→ | | | | Yes | False | | |
| → | CTRI/2021/08/035424 | 7 September 2021 | Study to evaluate the efficacy and safety of Molnupiravir capsules Compare with the with Standard of Care Medications Care alone in patients who are suffering with Moderate COVID-19 disease
| A Phase 3, Prospective, Open Label, Randomized, Multicenter, Parallel Study to evaluate the efficacy and safety of Molnupiravir capsules when administered along with Standard of Care compared to Standard of Care alone in Indian patients with Moderate COVID-19 disease - Version 2.0, Dated 08.06.2021 | | Aurobindo Pharma Limited | 04-08-2021 | 20210804 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58743 | Not Recruiting | No | | | | 10-08-2021 | 100 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 3 | India→ | Dr Subhra Lahiri→ | | AXIS Clinicals Ltd
1-121/1, Miyapur, Hyderabad
Telangana INDIA
AXIS Clinicals Ltd
1-121/1, Miyapur, Hyderabad
Telangana INDIA
→ | Subhra.L@axisclinicals.com→ | 8886221089→ | AXIS Clinicals Ltd→ | Inclusion criteria: 1. Male and/or female patients aged â?¥ 18 and â?¤ 60 years of age (both inclusive). <br/ ><br>2. Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent. <br/ ><br>3. Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization. <br/ ><br>4. Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization. <br/ ><br>a. Respiratory rate â?¥ 24/min, breathlessness <br/ ><br>b. SpO2: 90% to â?¤ 93% on room air <br/ ><br>5. Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on). <br/ ><br>6. Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit. <br/ ><br>7. Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization. <br/ ><br> Medically acceptable forms of contraceptive include: <br/ ><br>a. Hormonal contraceptives (at least 1 month before screening visit) <br/ ><br>b. Double barrier methods (e.g., diaphragm with spermicide; or condoms with spermicide) <br/ ><br>c. Intrauterine device (IUD) <br/ ><br>→ | Exclusion criteria: Inclusion Criteria: <br/ ><br>1. Male and/or female patients aged â?¥ 18 and â?¤ 60 years of age (both inclusive). <br/ ><br>2. Patients and LAR willing to comply with study protocol requirements and voluntarily able to provide written informed consent. <br/ ><br>3. Patients with positive for SARS-CoV-2 confirmed by RT-PCR in nasopharyngeal and/or oropharyngeal swabs within 5 days prior to randomization. <br/ ><br>4. Patients with presence of clinical features of dyspnea and or hypoxia, fever, cough, including one of the following symptoms at the time of screening and randomization. <br/ ><br>a. Respiratory rate â?¥ 24/min, breathlessness <br/ ><br>b. SpO2: 90% to â?¤ 93% on room air <br/ ><br>5. Patients with a risk factor for progressing to severe COVID-19 (i.e., who have co-morbid conditions diabetes, hypertension and so on). <br/ ><br>6. Male patients must agree to either abstain from sexual intercourse or to use contraception during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit. <br/ ><br>7. Female patients of childbearing potential must agree to either abstain from sexual intercourse or to use acceptable contraceptive method during the entire study duration and for a period of at least 04 days after the last dose of study medication or after the early withdrawal visit and must have negative urine pregnancy test prior to randomization. <br/ ><br> Medically acceptable forms of contraceptive include: <br/ ><br>a. Hormonal contraceptives (at least 1 month before screening visit) <br/ ><br>b. Double barrier methods (e.g., diaphragm with spermicide; or condoms with spermicide) <br/ ><br>c. Intrauterine device (IUD) <br/ ><br>Exclusion Criteria: <br/ ><br>1. Patients with known hypersensitivity to any of the excipients of the study medication or to any other similar class of drugs. <br/ ><br>2. Patients who participated in any other clinical trial of an experimental treatment for COVID-19 within 90 days prior to randomization. <br/ ><br>3. Patients infected post vaccination of either 1st or 2nd dose. <br/ ><br>4. Patients with pulse rate < 50 beats per minute at rest at the time of screening and randomization. <br/ ><br>5. Patient with severe COVID-19 with any of the following: respiratory failure (including endotracheal intubation and mechanical ventilation, oxygen delivered by high-flow nasal cannula (flow rates >20L/min with fraction of delivered oxygen â?¥0.5), noninvasive positive pressure ventilation, or extracorporeal membrane oxygenation (ECMO). <br/ ><br>6. Patients have hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis, end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3X upper limit of normal at screening. <br/ ><br>7. Patients with platelet count <100,000/μL or received a platelet transfusion within 5 days prior to randomization. <br/ ><br>8. Patients with AIDS-defining illness in the past 6 months. <br/ ><br>9. Patients with uncontrolled co-morbid conditions such as hypertension, diabetes, cardiovascular disease, chronic lung/ liver/ kidney disease, cerebro-vascular disease as per the investigatorâ??s discretion. <br/ ><br>10. Patients currently administering or anticipated to require Favipiravir, Oseltamivir or any other anti-viral treatments during study participation. <br/ ><br>11. Patients with Absolute Neutrophil Count (ANC) < 500 mm3. <br/ ><br>12. Patients currently administering immunosuppressive→ | Health Condition 1: J069- Acute upper respiratory infection,unspecified
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Molnupiravir capsules: 05 Days treatment. 1600 mgs/twice a day/Oral<br>Control Intervention1: Standard of Care Therapy: Standard of Care Therapy as per the Institution Practice and Based on Patient condition<br>→ | Proportion of patients with clinical improvement at Day 14. <br/ ><br>Clinical improvement is defined as 2-point decrease in clinical progression scale as recommended by WHO. <br/ ><br>Timepoint: Day 28→ | | | | Yes | False | | |
| → | CTRI/2021/08/035429 | 7 September 2021 | Effect of VAPcare device in prevention of ventilator associated events in patients on ventilator | Efficacy and safety of automated antiseptic lavage and
suctioning of oral, oro-pharyngeal and subglottic secretions (VAPCare)
among ventilated patients with COVID 19 in developing ventilator associated events
during hospitalization- a prospective randomised open blind end point study | | Dr Vimal Bhardwaj | 05-08-2021 | 20210805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57195 | Not Recruiting | No | | | | 10-08-2021 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | N/A | India→ | Dr Vimal Bhardwaj→ | | Department of MICU, 3rd Floor, A block, Mazumdar Shaw Medical Center, Narayana Hrudayalaya Ltd., NH Health City, 258/A Bommasandra Industrial Area, Anekal Tulak, Bangalore → | vimal.bhardwaj.dr@narayanahealth.org→ | 9686124830→ | Mazumdar Shaw Medical Center, Narayana Health city→ | Inclusion criteria: 1.all the patients aged more than or equal to 18 years, both genders in the emergency and medical/ surgical intensive care units who require artificial ventilation for more than 48 hours <br/ ><br>2.the patient/ legally authorized representative/ patient relative, provide written informed consent to participate in the study. <br/ ><br>3.Patient should be confirmed having COVID 19 infection by RTPCR/Antigen/CT Scan or any other approved method <br/ ><br>4.The patient is intubated within 24 Hours of vapcare device initiation <br/ ><br>→ | Exclusion criteria: 1.A regular ET tube other than ETT above the cuff suction enabled endotracheal tube <br/ ><br>2.A previous diagnosis of <br/ ><br>a.Pulmonary tuberculosis <br/ ><br>b.HIV <br/ ><br>c.Ventricular fibrillation <br/ ><br>d.Cardiac arrest <br/ ><br>e.Bleeding disorders <br/ ><br>f.Pregnancy <br/ ><br>g.Severe Head/ neck/ facial injuries <br/ ><br>3.Tracheostomy at the time of admission <br/ ><br>4.Patients enrolled for another clinical study <br/ ><br>→ | Health Condition 1: B97- Viral agents as the cause of diseases classified elsewhere
→ | Intervention1: Intervention group: VAPCare medical device with a disposable lumen (VAPLumen) that rides over the ET tube with ports in the oral and oropharyngeal area for suctioning secretions. Oral, oropharyngeal, and subglottic secretions are set to be drained automatically every 15 minutes or as per the intensivist. Oral lavage is performed by additional ports in the disposable part of lumen by sprinkling chlorhexidine every 3 hours or as per the intensivist. The chlorhexidine from pharynx is drained by the ports of the VAPLumen. The device will be used until the patient is on ventilator<br>Control Intervention1: Control group: Control group will receive the standard of care for the prevention of ventilator associated event as defined by existing hospital protocol viz. manual oropharyngeal suctioning as needed, subglottic suctioning every 2 hourly, tooth brushing once a day, chlorhexidine rinsing every 6th hourly until the patient is on ventilator<br>→ | 1.Incidence of VAE from date of intubation till 2 days post extubation/tracheostomyTimepoint: From intubation till 2 days post extubation→ | | | | Yes | False | | |
| → | CTRI/2021/08/035430 | 7 September 2021 | Clinical trial on Post covid fibrosis and idiopathic pulmonary fibrosis. | A prospective open label study to evaluate the efficacy and safety of
FIBROTAC Capsules in Post Covid Fibrosis and Idiopathic Pulmonary
Fibrosis | | Sooriya Hospita | 05-08-2021 | 20210805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57390 | Not Recruiting | No | | | | 06-08-2021 | 50 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India→ | DrAnandha Kumar→ | | No.1, Arunachalam Road,Ground floor room number 1
Department of Pulmonary Saligramam, Chennai → | venu.sooriya@gmail.com→ | 04423761751→ | Head of theDepartment of Pulmonary Medicine, Sooriya Hospital→ | Inclusion criteria: 1) Patients between age 18years and 70 years. <br/ ><br>2) One month after COVID 19 infection. <br/ ><br>3) RTPCR positive cases. <br/ ><br>4) Symptomatic and radiological evidence of POST COVID pulmonary fibrosis( PCILD). <br/ ><br>→ | Exclusion criteria: 1) Pregnant women, lactating mother <br/ ><br>2) Renal failure <br/ ><br>3) Hepatic failure <br/ ><br>4) Critically ill patients <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: fibrotac capsules: Dose : 440 mg<br>Dosage : Capsules twice daily <br>Duration :12 weeks<br><br>Control Intervention1: NIL: NIL<br>→ | 1. Improvement in 6minutes walk distance after 3 months of therapy. <br/ ><br>2. Subjective improvement in dyspnea and cough <br/ ><br>Timepoint: Day 0 to week 12→ | | | | Yes | False | | |
| → | CTRI/2021/08/035432 | 7 September 2021 | A clinical study to evaluate efficacy and safety of Nitric oxide nasal spray for treatment of COVID-19 in the adult non-hospitalized patients | A Randomized, Double-blind, Parallel Arm, Multicenter Study To Evaluate The Efficacy And Safety Of Nitric Oxide Nasal Spray Combined With Standard Supportive Care In Adult non-hospitalized Patients With COVID-19. | | Glenmark Pharmaceuticals Ltd | 05-08-2021 | 20210805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59084 | Not Recruiting | No | | | | 12-08-2021 | 306 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3 | India→ | Amol Pendse→ | | Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai Plot No. A-607, T.T.C. Industrial Area,
MIDC, Mahape, Navi Mumbai→ | Rahul.Kodgule@glenmarkpharma.com→ | 912240189999→ | Glenmark Pharmaceuticals Ltd→ | Inclusion criteria: 1. Voluntarily participating in the clinical study; fully understanding and being fully informed of the study and having signed the Informed Consent Form (ICF); willingness and capability to complete all the study procedures <br/ ><br>2. Age 18-65 years (inclusive) at the time of signing ICF <br/ ><br>3. Patients with laboratory confirmation of infection with SARS-CoV-2 by positive Rapid Antigen Test for SARS-CoV-2 at screening. <br/ ><br>4. Recent onset (within 48 hours of time of consent) symptoms of mild COVID 19 with oxygen saturation (SpO2 > 94 %) and respiratory rate < 24 breaths/min. <br/ ><br>5. For female subjects: evidence of post-menopause, or, for pre-menopause subjects, negative pretreatment urine pregnancy test <br/ ><br>6. Eligible subjects of child-bearing age (female or male with female partner of childbearing age) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment. <br/ ><br>7. Not participating in any other interventional drug clinical studies before completion of the present study. <br/ ><br>→ | Exclusion criteria: 1. Where, in the opinion of the investigator, participation in this study will not be in the best interest of the subject, or any other circumstances that prevent the subject from participating in the study safely <br/ ><br>2. Subjects with infection requiring oxygen support, invasive or non-invasive ventilator support, extracorporeal membrane oxygenation (ECMO) or shock requiring vasopressor support. <br/ ><br>3. Current known pneumonia based on x-ray or computed tomography (CT) scan or history of pneumonia within 3 months before screening. <br/ ><br>4. Requiring hospitalization for the treatment of COVID-19 <br/ ><br>5. Prolonged QT, defined as QTcF â?¥ 450 milliseconds for men and as QTcF â?¥ 470 milliseconds for women <br/ ><br>6. Requires ICU care for management of ongoing clinical status. <br/ ><br>7. Known allergy or hypersensitivity to Nitric Oxide Nasal Spray. <br/ ><br>8. Asthma, allergic rhinitis or chronic obstructive lung disease <br/ ><br>9. Pregnant or lactating women; <br/ ><br>10. Having used Nitric Oxide Nasal Spray or participated in any other interventional drug clinical study within 30 days prior to first dose of study drug.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Nitric Oxide<br>: Dosage Form: Nasal Spray<br>Dosage Frequency: two sprays each nostril, six times a day for up to maximum of 7 days. <br>Mode of Administration: Intranasal route of Administration<br><br>Control Intervention1: Placebo: Placebo of Nitric oxide nasal spray<br>→ | Change from baseline in log viral load. <br/ ><br> <br/ ><br>Co-Primary endpoint: Proportion of subjects with negative conversion of SARS-CoV 2 RT PCR.Timepoint: Change from baseline in log viral load <br/ ><br> <br/ ><br>For Co-primary: On Day 2, 4, and 8→ | | | | Yes | False | | |
| → | CTRI/2021/08/035444 | 7 September 2021 | An Observational study to compare the clinical outcomes of Ventilator Associated Events among COVID-19 and non COVID ICU patients. | A Prospective comparative study on the clinical outcomes of Ventilator Associated Events among COVID-19 and non COVID ICU patients. | | Lilavati hospital and research centre | 05-08-2021 | 20210805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58843 | Not Recruiting | No | | | | 10-08-2021 | 84 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Susan Philip→ | | Department of critical care medicine
Lilavati hospital and research centre
Bandra reclamation road
Bandra west
Mumbai → | conradruivas@lilavatihospital.com→ | 9820125932→ | Lilavati Hospital and Research Centre→ | Inclusion criteria: All patients who are above 18 years old and are admitted to the ICU and require mechanical ventilation for more than 2 days→ | Exclusion criteria: Patients on ECMO, ventilated for less than 48 hours, on NIV, who do not acheive stable ventilator settings after intubation or those who receives mechanical ventilation for more than 24 hours before ICU admission→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: NIL: NIL<br>→ | The primary outcome measured will be the rates of VAEs.Timepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/08/035445 | 7 September 2021 | IV THROMBOLYSIS(rt PA-Alteplase) AS TREATMEANT IN SEVERE COVID ARDS | IV THROMBOLYSIS(rt PA-Alteplase) AS TREATMEANT IN SEVERE COVID ARDS:A case series. - rt-PAC19SRDS | | COLUMBIA ASIA REFERRAL HOSITAL | 05-08-2021 | 20210805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49742 | Not Recruiting | No | | | | 20-08-2021 | 12 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr PRATHIBHA G A→ | | IST FLOOR, ICU, COLUMBIA ASIA REFERRAL HOSPITAL, 26/4, BRIGADE GATEWAY, BESIDE METRO, MALLESHWARAM, BANGALORE IST FLOOR, ICU, COLUMBIA ASIA REFERRAL HOSPITAL, 26/4, BRIGADE GATEWAY, BESIDE METRO, MALLESHWARAM, BANGALORE→ | prathibhaga@gmail.com→ | 9448996024→ | COLUMBIA ASIA HOSPITAL YESHWANTHPUR→ | Inclusion criteria: Severe COVID -19 ARDS (pao2:fio2 ratio <100) who are admitted to ICU→ | Exclusion criteria: Prior intracrainial hemorrhage <br/ ><br>Iaschemic stroke within 3 months <br/ ><br>Uncontrolled hypertension(BP >180/110) <br/ ><br>Major surgery within 3 months prior <br/ ><br>Non compressible vascular puncture→ | Health Condition 1: J80- Acute respiratory distress syndrome
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | ICU MORTALITYTimepoint: 28 DAY ICU mortality→ | | | | Yes | False | | |
| → | CTRI/2021/08/035447 | 7 September 2021 | The study will examine the lung tissue collected from a COVID-19 patient under the microscope. The findings from the microscopic examination will be compared to patient laboratory values. | Pathological lung patterns of COVID-19 disease and its clinical correlation to disease severity | | Dr Sagar Maddani S | 05-08-2021 | 20210805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59073 | Not Recruiting | No | | | | 23-08-2021 | 50 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Case Record Numbers Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Dr Sagar Maddani S→ | | Dept of Critical Care Medicine, Kasturba Medical College, Manipal. → | sagarmaddani04@gmail.com→ | 9764391100→ | Manipal Academy of Higher Education→ | Inclusion criteria: Those patients aged > 18 years admitted to Kasturba Hospital with diagnosis of COVID-19 infection and succumb to the illness→ | Exclusion criteria: Patients with age <18 years <br/ ><br>Patient relatives who are not willing to give consent for tissue sampling <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | To study the histopathological features of COVID-19 disease and correlate it to the clinical and laboratory findingsTimepoint: The day of death→ | | | | Yes | False | | |
| → | CTRI/2021/08/035466 | 7 September 2021 | Effect of Yoga on COVID 19 | â??Yoga Based Rehabilitation Program for patients with successfully
treated COVID 19â??
| | DST Satyam | 05-08-2021 | 20210805 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54675 | Not Recruiting | No | | | | 15-08-2021 | 30 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Upendra Baitha→ | | Dept of Medicine AIIMS New Delhi → | drupendraraj14@gmail.com→ | 01126593303→ | AIIMS New Delhi→ | Inclusion criteria: 1. Patients age more than 18 years who have been discharged after being admitted for the treatment of COVID 19. <br/ ><br>2. Patients required assisted respiratory therapy (O2 therapy, BiPaP ventilation or Mechanical ventilation) during Hospital stay. <br/ ><br>3. Willing to participate and give consent <br/ ><br>→ | Exclusion criteria: 1. Patients with known severe irreversible pulmonary diseases before getting infected with COVID 19 like COPD, ILD, Bronchiectasis needing domiciliary O2 therapy. <br/ ><br>2. Patients with severe obesity of musculoskeletal diseases making them unfit for practising Yoga. <br/ ><br>3. Severe end organ damage or chronic diseases: renal/ hepatic failure, any malignancy etc. that can lead to unfit for yoga practices. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: yoga therapy: post covid 19 discharged patient will be given yoga therapy for 3 months<br>Control Intervention1: Standard treatment: post covid discharged patient will be given standard treatment<br>→ | Yoga based rehabilitation program (Standard care with yoga sessions) will be more effective than standard care alone in post discharge recovery of moderately to severely ill patients with COVID 19.Timepoint: we will assess outcime measures after 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/08/035468 | 7 September 2021 | A clinical trial to evaluate the efficacy and safety precisely unveiled the comparative effectiveness of Sadangpaniya-phanta,Vayasathapana-kasya ghana tablet and Viyoshadi churna tablet in the treatment of COVID-19 | A randomized, open label,controlled,pragmatic trial to evaluate the efficacy and safety of Sadangpaniya phanta,Vayasathapana-kasaya ghana tablet and Viyoshadi churna tablet in the treatment of COVID-19 | | Dr Rajesh Adhana | 06-08-2021 | 20210806 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58077 | Not Recruiting | No | | | | 10-08-2021 | 70 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India→ | Dr Rajesh Adhana→ | | Dr Rajesh Adhana Medical Officer/Assistant Professor
Department of Toxicology
Gurukul Kangari parisar Uttrakhand Ayurved University Haridwar Gurukul kangari parisarUttrakhand Ayurved University Haridwar→ | vaidadhanarajesh@gmail.com→ | 9412956506→ | Gurukul Kangari parisar→ | Inclusion criteria: Patient with mild symptoms of covid-19( Rapid test and RT-PCR) positive case will be enrolled.→ | Exclusion criteria: Patient with moderate and sever Covid-19 infection having Pneumonia, Pregnant female patient with covid-19 infection will be excluded.→ | Health Condition 1: B338- Other specified viral diseases
Health Condition 2: B338- Other specified viral diseases
→ | Intervention1: Sadangpaniya kwath ,Viyosadi churn tablet ,Vyasthapan kasay ghana tablet: Sadangpaniya kwath ,Viyosadi churn tablet ,Vyasthapan kasay ghana tablet-INTERVENTION<br><br>Conventional allopathic treatment in mild case of Covid -19 confirm case<br>→ | Clinical recovery will be defined as sustained alleviation of illness based on symptom scores fever,cough,diarrhea,myalgia,dyspnea,all being absent.Timepoint: 10 days→ | | | | Yes | False | | |
| → | CTRI/2021/08/035492 | 7 September 2021 | Effect of PNF stretching and chest mobility exercises in Covid-19 survivors | "Effect of PNF Pectoral Stretching and Chest Mobility Exercises on Chest Expansion,Fatigue and Pulmonary Functions in Covid-19 Survivors" | | NIL | 06-08-2021 | 20210806 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59125 | Not Recruiting | No | | | | 16-08-2021 | 40 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Participant Blinded | Phase 2/ Phase 3 | India→ | Merin Shaji→ | | Dr. D.Y. Patil College of Physiotherapy Dr. D. Y. Patil Vidyapeeth Pimpri Pune Dr. D.Y. Patil College of Physiotherapy Dr. D. Y. Patil Vidyapeeth Pimpri Pune→ | divya.gohil@dpu.edu.in→ | 7767828290→ | Dr. D. Y. Patil College of Physiotherapy→ | Inclusion criteria: Post Covid patients with mild and moderate recovery- <br/ ><br>Asymptomatic <br/ ><br>Does not need oxygen support on exercise or activity <br/ ><br>MMRC dyspnea grade <2 <br/ ><br>Subjects who are independent in mobility <br/ ><br>Subjects willing to participate. <br/ ><br>Duration : 6-8 months after recovery <br/ ><br>Baseline values for chest expansion: <br/ ><br>Upper thoracic: male- 2.6+1.4cm <br/ ><br> female- 2.2+1.2cm <br/ ><br>Lower thoracic: male- 2.3+1.1.2cm <br/ ><br> female- 1.7+1.1cm <br/ ><br> <br/ ><br> <br/ ><br>→ | Exclusion criteria: Any musculoskeletal disorders affecting upper limb. <br/ ><br>Any pathological condition affecting muscle, joint and bone Such as rheumatoid arthritis, severe osteoporosis. <br/ ><br>Cardiovascular dysfunction (eg, ischemic heart disease, uncontrolled hypertension) <br/ ><br>Additional conditions restricting chest expansion. (eg, obesity, severe scoliosis, ankylosing spondylitis) <br/ ><br>Recent chest or abdominal surgery. <br/ ><br>Pathology of spine such as disc protrusion, spondylolisthesis. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J984- Other disorders of lung
→ | Intervention1: Chest mobility exercises: Each exercises listed below will be repeated 6 times on each side with rest of period for 30 seconds in between. The intervention will be carried out for one week with total of 7 sessions. Each Exercise will be accompanied by breathing pattern. In neutral position of exercises, subjects will be asked to exhale during flexion, turning or extension subject would be asked to do inhale.<br>1. Rib rotation: Subject in supine lying, therapist standing on opposite side facing subject, stretches right side of chest placing hands on one side of rib cage and giving opposite directional forces and same will be performed on other side.<br>2. Passive lateral flexion in side lying on pillows: Subject lying on one side on 2 pillows Therapist stretches the upper side of thorax with shoulder abduction. The same exercise will be repeated on other side.<br>3. Trunk rotation in sitting position: Active and passive trunk rotation on both sides were performed. Exhalation in a forward position will be carried out at the beginning of flexion, and rotation of the left side will be performed laterally with inspiration.<br>4. Direct rib stretching: Subject in supine lying with arms folded and hands clasped on back of neck, therapist performs flexion and extension of the subject thorax.<br><br>Control Intervention1: PNF Pectoral Stretching: Hold-relax PNF Stretching<br>subject will be asked to contract the pectoral muscles to move the limb into the direction of glenohumeral horizontal flexion, in the maintained position to meet the 50-60% resistance applied by the therapist. This isometric contraction will be held for 6sec. Patient then relaxed and passive stretch in the opposite direction.<br>6 times with rest period of 30sec<br>→ | Pulmonary Function-SpirometryTimepoint: 7 sessions/1week. <br/ ><br>pulmonary function will be assesed with spirometry on the first session and after the last session.→ | | | | Yes | False | | |
| → | CTRI/2021/08/035514 | 7 September 2021 | A clinical trial to study efficacy and safety of Imatinib mesylate in COVID-19 Complications. | A randomized, double-blind, multicenter 2-arm, parallel-group, placebo-controlled study to investigate the efficacy and safety of intravenous imatinib mesylate in reducing the severity of hypoxemic respiratory failure in patients with critical COVID-19 receiving standard of care. - IMPRESS-COVID | | Exvastat Limited | 09-08-2021 | 20210809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56575 | Not Recruiting | No | | | | 09-08-2021 | 84 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | Dr Ramesh K S→ | | Clinical development, Tower-1, Semicon Park Electronics City, Phase-2, Hosur Road → | Ramesh.Ks@syngeneintl.com→ | 9686679369→ | Syngene International Ltd→ | Inclusion criteria: Male or female patients aged â?¥18 years; Women of childbearing potential must have a negative serum pregnancy test to confirm eligibility, Provision of signed written informed consent from the patient or patientâ??s legally acceptable representative, SARS-CoV-2 infection confirmed by RT-PCR laboratory test (which may include results from a test that was performed prior to hospital admission if, in the opinion of the Investigator, it is relevant to ongoing COVID-19), Meet Berlin definition for moderate â?? severe ARDS: <br/ ><br>â?¢Bilateral opacities â?? not fully explained by effusions, lobar/lung collapse, or nodules <br/ ><br>â?¢Respiratory failure not fully explained by cardiac failure or fluid overload. <br/ ><br>â?¢PaO2/FIO2 â?¤200 mmHg with PEEP â?¥5 cmH2O; Patient requires intubation or is currently intubated and has been for â?¤48 hours.→ | Exclusion criteria: Persistent septic shock ( >24 hours) with a Mean Arterial Pressure (MAP) â?¤65 mm Hg and serum lactate level >4 mmol/L (36 mg/dL) despite adequate volume resuscitation and vasopressor use (norepinephrine >0.2 μg/kg/min) for >6 hours, major trauma in the past 5 days, Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last year,Pre-existing severe cardiopulmonary disease including, but not limited to, interstitial lung disease; severe COPD (GOLD Stage IV or FEV1 <30% predicted); heart failure (estimated left ventricular ejection fraction <40%); or a chronic lung condition requiring home oxygen treatment,An underlying clinical condition that, in the opinion of the Investigator, would make it very unlikely for the patient to be successfully weaned from ventilation due to severe underlying diseases (e.g., severe malnutrition, severe neurological disease),Patients considered inappropriate for critical care (e.g., being considered for palliative care),Currently receiving extracorporeal membrane oxygenation (ECMO), Severe chronic liver disease with Child-Pugh score >12 (Appendix 1),White blood count <2.5 x 109/L, or Hemoglobin <4.0 mmol/L(6.5g/dL), or Platelets <50 x 109/L;ALT or AST >10x upper limit of normal (ULN) or bilirubin >3x ULN, Women who are pregnant or breast-feeding; <br/ ><br>Use of drugs with strong CYP3A4 induction potential, such as carbamazepine, efavirenz, enzalutamide, phenobarbital, phenytoin, hypericum, mitotane, nevirapine, primidone, rifabutin and rifampicin;Inability of the ICU staff to initiate administration of study treatment within 48 hours of intubation; Enrolled in a concomitant clinical trial of an investigational medicinal product, In the opinion of the investigator, progression to death is highly probable, irrespective of the provision of treatments.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | Intervention1: Imatinib 8 mg/mL: 25 mL of study drug administered as an IV infusion over two hours (12.5mL/hour)twice daily for 10 days.<br>Control Intervention1: Placebo: 25 mL of study drug administered as an IV infusion over two hours (12.5mL/hour)twice daily for 10 days.<br>→ | To evaluate the efficacy of IV imatinib compared to placebo in reducing ARDS severity in patients with critical COVID-19 receiving standard of care.Timepoint: Change (from baseline) in Oxygen Saturation Index (OSI) at Day 10→ | | | | Yes | False | | |
| → | CTRI/2021/08/035520 | 7 September 2021 | Impact of Exercise Protocol through Telerehabilitation in Post COVID Patients. | Impact of Exercise Protocol through Telerehabilitation in Post COVID Patients. | | Madhuri | 09-08-2021 | 20210809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54230 | Not Recruiting | No | | | | 12-08-2021 | 60 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | N/A | India→ | Vandana Rani→ | | Department of Physiotherapy room no 101 GJUST Hisar Haryana Department of Physiotherapy room no 101 GJUST Hisar Haryana→ | dr.vandanaravi7@gmail.com→ | 9034627420→ | GJUST Hisar Haryana→ | Inclusion criteria: 1) Age 18- 75 years. <br/ ><br>2) Patient who are affected with corona virus and are in home confinent. <br/ ><br>3) Having at least one r-T-PCR COVID report. <br/ ><br>4) Ability to walk. <br/ ><br>5) Ability to use smartphone. <br/ ><br>6) Patient likely to benefit from on call physiotherapy. <br/ ><br>7) Controlled asthma with evidence of infection, retained secretion, increase work of breathing. <br/ ><br>→ | Exclusion criteria: 1) Patients with chronic lung disease, kidney disease, neurological disorder. <br/ ><br>2) Patients affected with acute phase of disc abnormalities. <br/ ><br>3) Patients who have had respiratory conditions in the last 12 months. <br/ ><br>4) Patients who have recent musculoskeletal disorders and who are not fully recovered from their injuries. <br/ ><br>5) Viral pneumonia. <br/ ><br>6) Uncooperative patients. <br/ ><br>7) Uncontrolled bronchospasm. <br/ ><br>8) Pregnancy and lactating mothers. <br/ ><br>9) Red flags for serious conditions (night pain, severe muscle spasm, loss of involuntary weight, symptoms mismatch). <br/ ><br>10) Their disease in which exercise is unsuitable. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Experimental group: The total of 30 minutes exercises that included combination of strengthening and stretching exercise for both limbs and breathing exercises for respiratory tract for alternate days/4 weeks through telerehabilitation<br>Control Intervention1: control group: participants were instructed to do for atleast 10 minutes per days.<br>→ | physical performance <br/ ><br>lower limb strength <br/ ><br>health related quality of lifeTimepoint: Baseline <br/ ><br>4 weeks <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/08/035537 | 7 September 2021 | Reducing hypoxia in patients with COVID-19 using Topotecan with standard of care
| Phase I dose-escalation study of Topotecan in moderate-severe COVID-19 patients - nil | | National University Cancer Institute of Singapore NCIS National University Hospital Singapore | 09-08-2021 | 20210809 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59240 | Not Recruiting | No | | | | 16-08-2021 | 24 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 1 | India→ | Dr Ajoy Oommen John→ | | Department of Medical Oncology, Christian Medical College, Ida
Scudder Road, Vellore- 632004, Tamil Nadu, India
Vellore
TAMIL NADU
632004
India → | ajoyoommenjohn@gmail.com→ | 7639195315→ | Christian Medical College,→ | Inclusion criteria: SARS-CoV-2 infection confirmed by at least 1 positive PCR test <br/ ><br>Moderate COVID as evidenced by Oxygen saturation <93% on room air (or <88% if prior CLD) <br/ ><br>Admission to emergency department for monitoring and/or supportive care: <br/ ><br>Risk of COVID deterioration, as defined as elevation in any one of: <br/ ><br>CRP > 75mg/L <br/ ><br>LDH > ULN <br/ ><br>D-dimer > 1.0 mg/L <br/ ><br>Ferritin > 500ng/ml <br/ ><br>Elevated IL-6 levels <br/ ><br>→ | Exclusion criteria: Mechanically ventilated/ intubated patients <br/ ><br>The following biochemical markers: <br/ ><br>Absolute neutrophil count (ANC) < 1.5 x 109/L. <br/ ><br>Platelets < 100 x 109/L <br/ ><br>Haemoglobin < 9x 109/L. <br/ ><br>Bilirubin â?¥ 1.5 times upper limit of normal (ULN). <br/ ><br>ALT and AST â?¥ 2.5 times ULN. <br/ ><br>Calculated creatinine clearance of < 30ml/min calculated using the formula of Cockcroft and Gault: (140-age) x mass (kg)/)72x creatinine mg/dl); multiple by 0.85 if female. <br/ ><br> <br/ ><br>Uncontrolled bacterial, fungal, non-COVID viral infection <br/ ><br>Poorly controlled diabetes mellitus (HbA1c > 8% in the past month) <br/ ><br>Known hypersensitivity to Topotecan <br/ ><br>Use of any other immunosuppressive medication (excluding steroids) administered concurrently or within last 14 days. <br/ ><br>Pregnancy/ breast-feeding <br/ ><br>Enrolment in other therapeutic trial of COVID-19 <br/ ><br>Any condition that would, in the opinion of the Investigator, increase the risk of the participant by participating in the study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Topotecan<br>Dexamethasone<br>Remdesivir: The drugs will be administered as follows:<br>Inj. Topotecan 0.25mg IV in 100ml Normal saline over 30 minutes given as a single dose on D2 of<br>admission. <br>Tab. Dexamethasone<br>6mg OD D1-10 of admission, given orally. Tab.<br>Remdesivir 100mg/day D1-5 of admission,<br>given orally. If primary outcome of elevated<br>serum Topotecan levels and neutropenia is not<br>achieved after 3 patients, another 3 patients<br>will be recruited at the same dose level. If<br>outcome is not achieved, then the dose of<br>topotecan will be escalated to 0.25mg OD for D2 and D3 and the protocol repeated for another 6 patients. If still unachieved, then the next dose escalation to<br>Topotecan 0.5mg OD D2 will be conducted for another 6 patients. If still unachieved then the final dose escalation of Injection topotecan 0.5mg OD on D2 and D3 will be done.<br>Control Intervention1: not applicable: not applicable<br>→ | To determine a maximal dose, out of 4 pre-specified dosing levels of Topotecan, at which less than 1 out of 3 patients exhibit anti-cancer concentrations in plasma (defined as AUC 150000/CMax1000), or have G2/3/4 neutropeniaTimepoint: To determine a maximal dose, out of 4 pre-specified dosing levels of Topotecan, at which less than 1 out of 3 patients exhibit anti-cancer concentrations in plasma (defined as AUC 150000/CMax1000), or have G2/3/4 neutropenia→ | | | | Yes | False | | |
| → | CTRI/2021/08/035552 | 7 September 2021 | Immuno- modulatory Potential of AyurRaksha Kit and its Preventive Impact on COVID 19 in Delhi police | evaluation of the immuno - modulatory Potential of AyurRaksha Kit on a Larger Cohort of Delhi Police to Assess Prophylactic Impact on COVID 19 - An Exploratory Study | | Ministry of AYUSH | 10-08-2021 | 20210810 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58906 | Not Recruiting | No | | | | 16-08-2021 | 80000 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Umesh Tagde→ | | Joint Director office ,Academic block,Ground Floor, All India Institute of Ayurveda,gautampuri awas,Sarita vihar, New Delhi -110076 → | dr.ananthramsharma@gmail.com→ | 9495130595→ | All India Institute of Ayurveda→ | Inclusion criteria: 1.All police personnel on record and on duty <br/ ><br>2.Police Personnels willing to consume and follow Ayur Raksha Kit <br/ ><br>3.Individuals agree to give consent for participation <br/ ><br>→ | Exclusion criteria: 1.Those who are presently infected with Covid-19→ | | | 1.Baseline survey would generate information on occurrence of covid19 infection during past 4 months (as reference time) and other demographical data. <br/ ><br>2.The change in immunity status as measured by ISQ would be assessed. <br/ ><br>Timepoint: 120 days→ | | | | Yes | False | | |
| → | CTRI/2021/08/035567 | 7 September 2021 | Efficacy of Indomethacin along with standard care of treatment versus standard care of treatment in hospitalized Severe Covid -19 patients | A Prospective, Randomized, open-labelled, active Comparator trial of Indomethacin and standard care versus Standard care among hospitalized severe Covid-19 patients. | | IIT Madras | 10-08-2021 | 20210810 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59338 | Not Recruiting | No | | | | 19-08-2021 | 100 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Ramarathnam Krishna Kumar→ | | Department of Engineering Design, Frist floor, 212, Indian Institute of Technology Madras, Chennai, India. → | ravidoc55@yahoo.co.in→ | 9840375892→ | MIOT International→ | Inclusion criteria: Age between 20 to 90 years <br/ ><br> <br/ ><br>RT â?? PCR Positive <br/ ><br> <br/ ><br>Hospitalised patients <br/ ><br> <br/ ><br>dyspnea <br/ ><br> <br/ ><br>A blood oxygen saturation of 93% or less <br/ ><br> <br/ ><br>A ratio of the partial pressure of arterial oxygen to the fraction of inspired oxygen (Pao2:Fio2) of less than 300 mm Hg, or infiltrates in more than 50% of the lung field <br/ ><br>→ | Exclusion criteria: Hypersensitivity/Allergy to Drug <br/ ><br> <br/ ><br>Gastritis <br/ ><br> <br/ ><br>Recent Heart attack <br/ ><br> <br/ ><br>Severe Asthma <br/ ><br> <br/ ><br>Acute Kidney Injury <br/ ><br> <br/ ><br>Patients with known history of Indomethacin allergy will be excluded from the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Indomethacin: Drug dose - Capsule (C) - 75 mg sustained release<br>formulation once daily for 7 days for subjects with<br>BMI less than 30; C. 75 mg twice daily for 5 days for<br>subjects with BMI more than 30 will be administered<br>orally, along with standard care of treatment followed in the hospital<br>Control Intervention1: Paracetamol: Tablet - paracetamol 650 mg 4 times daily for 5 days<br>along with same standard care of treatment followed in the hospital as advised by regulatory bodies<br><br>→ | Reduction in Covid-19 symptoms and the intervention is expected to be beneficial in reducing the Covid 19 symptoms than the comparatorTimepoint: Day 0 screening <br/ ><br>Day 1 to 7 drug <br/ ><br>Day 28 end of the study→ | | | | Yes | False | | |
| → | CTRI/2021/08/035593 | 7 September 2021 | Clinical study of Ulinastatin along with standard of care in comparison to standard of care alone (Pooled historical data) in hospitalised moderate COVID-19 patients | An Investigator Initiated Prospective Multicentre, Double arm Interventional study of Ulinastatin
along with SOC in comparison to SOC alone (Pooled historical data) in hospitalised Subjects with moderate COVID-19. | | Dr Manjunath B G | 11-08-2021 | 20210811 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59126 | Not Recruiting | No | | | | 16-08-2021 | 60 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Participant Blinded | Phase 4 | India→ | Dr Manjunath B G→ | | department of
pulmonary & critical
care medicine, Medical Rd, Rohtak, Haryana → | bgmanzu@gmail.com→ | 8050452310→ | Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences→ | Inclusion criteria: For Arm 1 & 2: <br/ ><br>Patients who meet all the following criteria are eligible to be enrolled <br/ ><br>in the study: <br/ ><br>-Males/females of â?¥ 18 years to â?¤ 65 years of age at the time of <br/ ><br>consent. <br/ ><br>-Patients who can and willing to provide written Informed Consent (applicable only for Arm 1). <br/ ><br>-Hospitalized patients with confirmed diagnosis of moderate severity of COVID-19 infection with a real time or conventional RT-PCR positive test report (generated <72 hrs from baseline) from an ICMR approved laboratory for COVID testing. <br/ ><br>-Patients with SpO2 between 93 % - 90 % on room air. <br/ ><br>-Patients with Respiratory Rate â?¥24 breath /min. <br/ ><br>-Patients who are hospitalized within 24 hours at the time of enrolment. <br/ ><br> <br/ ><br>Additionally for Arm 2: <br/ ><br>-Patients discharged as per discharge criteria (defined in Protocol <br/ ><br>Section-5). <br/ ><br>-Patients with minimum one post discharge follow-up after 28 days of admission. <br/ ><br>-Patients for whom ordinal scale assessment is done during admission and discharge.→ | Exclusion criteria: Patients with any of the following are not to be enrolled in the study: <br/ ><br>-Patients who fall under mild or severity of COVID-19 (defined in Protocol section 5). <br/ ><br>-Patients with history of HIV/HCV/HBV positive or immunocompromised or tuberculosis. <br/ ><br>-Patients with significant co-morbidities at screening, as judged by the treating Investigator. <br/ ><br>-Patients with Moribund state in which death is perceived to be <br/ ><br>imminent (48 hours). <br/ ><br>-Patients with Chest CT severity score >15. <br/ ><br>-Patients with suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19). <br/ ><br>-Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs/convalescent plasma. <br/ ><br>-Patients who require mechanical ventilation or ECMO at Screening. <br/ ><br>-Patients with persisting hypotension despite volume resuscitation, requiring vasopressors to maintain MAP â?¥65 mmHg at screening. <br/ ><br>-Patients who have participated in any other clinical study within past three months. <br/ ><br>-Patients with known hypersensitivity to Ulinastatin. <br/ ><br>-Female patient who is breast-feeding, pregnant, or intends to <br/ ><br>become pregnant during the study.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Ulinastatin along with standard of care: The subjects will be administered with study product three times a day (Every 8 hours) for 5 to 7 days (as per PIs discretion). Each dose consists of 2 Vials (200,000 IU) of Ulinastatin (diluted in 100 ml of 0.9% saline) and is infused over 1hr.<br><br><br>Control Intervention1: Only SOC: Historical data collection for Arm 2 will be initiated once the sites complete<br>the enrollment of all the prospective subjects in Arm 1 at their respective<br>sites.<br>At each site, if â??nâ?? number of subjects are enrolled in Arm 1 then the<br>historical data collection will start on the day of enrollment of nth subject at<br>that site. The hospital records of the last â??nâ?? number of patients admitted<br>within 6 months before the day of SIV and the patients who fulfill the<br>eligibility criteria of this protocol will be enrolled sequentially in descending<br>order into Arm 2.<br>→ | 1.Incidences of all-cause mortality [Time Frame: From date of Drug administered until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 28 days, in both Arms] <br/ ><br> <br/ ><br>2.Evaluation of Clinical progression based on 8-point ordinal scale (recommended by the World Health Organization: Coronavirus disease (COVID- 2019) R and D) [Time frame: baseline to EoT, in both Arms]. <br/ ><br>Timepoint: 1. From date of Drug administered until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 4 weeks, in both Arms] <br/ ><br> <br/ ><br>2. Baseline to 4 weeks, in both Arms <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/08/035614 | 7 September 2021 | Air Vaidya herbal dhupa for prevention of Covid 19. | Efficacy of Air Vaidya herbal dhupa in prevention of COVID-19 among residents of Varanasi, Eastern UP: A randomized control trial. - AIRVAIDHU | | AMIL PHARMACEUTICALS INDIA Ltd | 12-08-2021 | 20210812 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59213 | Not Recruiting | No | | | | 15-08-2021 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Alternation Blinding and masking:Open Label | Phase 2 | India→ | K R C Reddy→ | | Dept. of Rasa Shastra
Faculty of Ayurveda
Institute of Medical Sciences
Banaras Hindu University
Varanasi
Uttar Pradesh
India
221005 → | krcreddy@bhu.ac.in→ | 9415813533→ | Institute of Medical Sciences, Banaras Hindu University→ | Inclusion criteria: i. People of both genders apparently healthy and willing to take complete course of therapy. <br/ ><br>ii. People aged 18 to 50 years <br/ ><br>iii. People willing to give written informed consent <br/ ><br>→ | Exclusion criteria: i. Subjects aged less than 18 years <br/ ><br>ii. Pregnant women <br/ ><br>iii. Subjects with malignancy and those with advanced liver or kidney diseases. <br/ ><br>iv. People who are cognitively impaired/having mental disorders. <br/ ><br>v. People having symptoms of COVID 19 at time of enrolment <br/ ><br>vi. People tested positive for COVID-19 last within 4 weeks <br/ ><br>vii. People suffering from bronchial Asthma. <br/ ><br>viii. People allergic to inhalation of DHUPA→ | | | 1. Number of people found to have RT-PCR positive COVID-19 infection both in intervention and control groups in the follow up period. <br/ ><br>2. Number of people contracting other respiratory infections both in intervention and control groups in the follow up period.Timepoint: 30 days→ | | | | Yes | False | | |
| → | CTRI/2021/08/035620 | 7 September 2021 | COVID-19 and Mental Health | Mental Health Problems in COVID-19: A Multi-centric Study in Eastern and North Eastern India - COMENTAL | | Indian Council of Medical Research | 12-08-2021 | 20210812 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58586 | Not Recruiting | No | | | | 01-12-2021 | 4590 | Observational | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India→ | Prof Dr Amit Chakrabarti→ | | ICMR Centre on Non Communicable Diseases
Division of Non Communicable Diseases NCD
Indian Council of Medical Research ICMR
Block DP1 Sector V Salt Lake
Kolkata → | amit.chakrabarti@gov.in→ | 9674566502→ | ICMR Centre on Non Communicable Diseases→ | Inclusion criteria: COVID 19 survivor, one family member, representative community sample.→ | Exclusion criteria: Participants with cognitive and other disability, which makes them unsuitable for participation.→ | | | 1. Estimates of common mental disorders among COVID-19 survivors and other high risk groups. <br/ ><br>2. Utilization of available mental health services by the affected population. <br/ ><br>3. Identification of preventable risk factors for mental health problems in the context of COVID-19 pandemic.Timepoint: 9 and 12 months→ | | | | Yes | False | | |
| → | CTRI/2021/08/035628 | 7 September 2021 | Mind Body Techniques for Healthcare Workers | Design And Validate Mind Body Techniques For Resilience Building And Wellness Of Health Care Workers Engaged In A Stressed Environment Laden With Uncertainty | | Department of Science and Technology Covid SATYAM Special Call | 13-08-2021 | 20210813 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55146 | Not Recruiting | No | | | | 23-08-2021 | 112 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India→ | DrDCMathangi→ | | Sri Ramachandra Nagar
Porur
Chennai → | dcmathangi@gmail.com→ | 9940635874→ | Sri Ramachandra Institute of Higher Education and Research→ | Inclusion criteria: 1. Duration of posting on COVID duty : 2 â?? 4 wks <br/ ><br>2. Specialization : Any Medical/Nursing specialization <br/ ><br>3. Willing to participate <br/ ><br>4. Willing to practice the MBT Intervention protocol <br/ ><br>→ | Exclusion criteria: 1. Already on any antipsychotic drugs <br/ ><br>2. Family discord <br/ ><br>3. Personal tragedy <br/ ><br>4. hypertension <br/ ><br>5. respiratory pathology like asthma <br/ ><br>6. recent myocardial infarction <br/ ><br>7. unstable angina <br/ ><br>8. diabetes mellitus <br/ ><br>9. thyroid abnormality â?? both hypo and hyperthyroid <br/ ><br>10. neurological or cognitive disorders with functional deficits, <br/ ><br> <br/ ><br>→ | | Intervention1: Mind Body Techniques: 8 week Mind Body Techniques with reflective practice would be given.<br>Control Intervention1: As this is a single arm study no comparator: As this is a single arm study no comparator<br>→ | Levels of Stress, Anxiety and Depression, Quality of life, SleepTimepoint: 1. At Baseline <br/ ><br>2. At the end of 8 Weeks→ | | | | Yes | False | | |
| → | CTRI/2021/08/035648 | 7 September 2021 | Mixing of COVID vaccines study | Comparison of reactogenicity and immunogenicity of heterologous prime-boost and heterologous boost of ChAdOx1 nCoV-19 (Covishield), BBV 152 (Covaxin), and other COVID vaccines with homologous administration of Covishield and Covaxin - MnM study | | Christian Medical College | 13-08-2021 | 20210813 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59405 | Not Recruiting | No | | | | 21-08-2021 | 1100 | PMS | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Post Marketing Surveillance | India→ | Winsley Rose→ | | Department of Child Health-Unit III and Pediatric Infectious Diseases, Christian Medical College, Ida Scudder Road, Vellore → | winsleyrose@cmcvellore.ac.in→ | 9698884466→ | Christian Medical College→ | Inclusion criteria: 1. Males and females aged 18+ years <br/ ><br>2. No known immunodeficiency <br/ ><br>3. History of no contact with COVID-2019 persons within at least 14 days before the enrolment (according to subjects) <br/ ><br>4. No evident vaccine-induced reactions or complications after receiving immunobiological products in the medical history <br/ ><br>5. No acute infectious and/or respiratory diseases within at least 14 days before the enrolment. <br/ ><br>→ | Exclusion criteria: 1. Previous receipt of any COVID vaccine (only for those who are in the prime and boost part of the study) <br/ ><br>2. Any vaccination/immunization within 30 days before the enrolment <br/ ><br>3. Steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrolment <br/ ><br>4. Immunosuppressors therapy finished within 3 months before the enrolment <br/ ><br>5. Pregnancy or breast-feeding <br/ ><br>6. Acute coronary syndrome or stroke suffered less than one year before the enrolment <br/ ><br>7. Tuberculosis, chronic systemic infections <br/ ><br>8. Drug allergy â?? history of anaphylaxis, hypersensitivity or allergic reaction to immunobiological products, known allergic reactions to study product components, acute exacerbation of allergic diseases on the enrolment day <br/ ><br>9. Subjects who are on drugs that could have potential drug interactions with the vaccines: <br/ ><br>A.drugs for multiple sclerosis (dimethyl fumarate, fingolimod, ozanimod, etc.), <br/ ><br>B. monoclonal antibodies, corticosteroids, corticotropin, <br/ ><br>C. antineoplastic drugs, cytostatic agents (platinum-based drugs, bleomycin, taxanes, methotrexate, melphalan, capecitabine, carmustine, vincristine, vinblastine, cyclophosphamide, cyclosporine, docetaxel, doxorubicin, daunorubicin, fluorouracil, etc.) and target drugs (dasatinib, lenalidomide, nilotinib, pemetrexed, everolimus, sirolimus, asparaginase, bortezomib, etc.), <br/ ><br>D. immunoglobulins, interleukins, X-ray contrast agents <br/ ><br>10. Medical history of malignancy <br/ ><br>11. Donated blood or plasma (450+ mL) within 2 months before the enrolment <br/ ><br>12. Splenectomy in the medical history <br/ ><br>13. Neutropenia (absolute neutrophil count <1000 mm3, agranulocytosis, significant blood loss, severe anaemia (haemoglobin <80g/l) immunodeficiency including autoimmune disorders in the medical history within 6 months before the enrolment <br/ ><br>14. Known HIV positive <br/ ><br>15. Local inflammation at injection site (deltoid muscle area), which does not allow assessing the local response to the vaccine administration <br/ ><br>16. Alcohol or drug addiction in the medical history <br/ ><br>17. Participation in any other interventional clinical trial within 1 month prior to the screening <br/ ><br>17. Any other medical condition that would limit the participation of the subject as per Investigatorâ??s discretion <br/ ><br>18. Subjects contraindicated for vaccination <br/ ><br> <br/ ><br>Temporary exclusion criteria: <br/ ><br> <br/ ><br>If at visit 1 screening/ vaccination the volunteer has any of the following, they will not be enrolled that day. <br/ ><br>1. Acute respiratory illness (moderate or severe illness with or without fever) <br/ ><br>2. Fever (oral temperature greater than 37.8°C) <br/ ><br>They may be considered for enrolment later in the trial; if they recover in sufficient time. <br/ ><br>→ | | Intervention1: Covaxin followed by Covishield followed by booster Covaxin: 0.5 ml Intramuscular<br>Intervention2: Covishield followed by Covaxin followed by booster Covishield: 0.5 ml Intramuscular<br>Intervention3: Homologous Covaxin followed by a booster: 0.5ml Intramuscular<br>Intervention4: Covaxin followed by Covishield followed by booster Covishield: 0.5ml Intramuscular<br>Intervention5: Covishield followed by Covaxin followed by booster Covaxin: 0.5 ml Intramuscular<br>Intervention6: Covaxin booster to already Covishield vaccinated with 2 doses: 0.5 ml Intramuscular<br>Intervention7: Covishield booster to already Covaxin vaccinated with 2 doses: 0.5 ml Intramuscular<br>Control Intervention1: Homologous Covishield followed by a booster: 0.5 ml Intramuscular<br>Control Intervention2: Homologous Covaxin 2 primary doses followed by booster Covaxin: 0.5 ml Intramuscular<br>Control Intervention3: Homologous Covaxin 2 primary doses followed by booster Covishield: 0.5 ml Intramuscular<br>Control Intervention4: Homologous Covishield 2 primary doses followed by booster Covishield: 0.5 ml Intramuscular<br>Control Intervention5: Homologous Covishield 2 primary doses followed by booster Covaxin: 0.5 ml Intramuscular<br>Control Intervention6: Covishield booster to already Covishield vaccinated with 2 doses: 0.5 ml Intramuscular<br>Control Intervention7: Covaxin booster to already Covaxin vaccinated with 2 doses: 0.5 ml Intramuscular<br>→ | Immunogenicity measured by anti spike immunoglobulins for SARS CoV 2Timepoint: Boost Only - Day 28 after the booster dose <br/ ><br> <br/ ><br>Prime/boost - Day 28 after the second dose of the 2 primary vaccine doses→ | | | | Yes | False | | |
| → | CTRI/2021/08/035655 | 7 September 2021 | Effectiveness of Covid-19 vaccination and incidence of SARS-COV-2 reinfection in healthcare and frontline workers working in a tertiary cancer centre of India. | A retrospective study to assess the effectiveness of Covid-19 vaccination and incidence of SARS-COV-2 reinfection in healthcare and frontline workers working in a tertiary cancer centre of India. - NO | | Tata Memorial Centre | 13-08-2021 | 20210813 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59291 | Not Recruiting | No | | | | 23-08-2021 | 1760 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sudeep Gupta→ | | Tata Memorial Hospital,
Homi Bhabha Block
Room no 1109, 11th floor
Dr. Ernest Borges Marg.
Parel Mumbai → | sudeepgupta04@yahoo.com→ | 912224177201→ | Tata Memorial Centre→ | Inclusion criteria: 1.Healthcare and frontline workers from a single tertiary cancer centre <br/ ><br>2.HCW and FLW between the age of 18-80 years and willing for the vaccination <br/ ><br>→ | Exclusion criteria: 1.Non-healthcare care and non- frontline workers <br/ ><br>2.Healthcare and frontline workers from other hospitals <br/ ><br>→ | | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Primary outcome <br/ ><br>1. To assess the efficacy of vaccination for the prevention of SARS-COV-2 in healthcare and frontline workers. <br/ ><br> <br/ ><br>Timepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/08/035670 | 7 September 2021 | Rhinocerebral Mucormycosis in COVID-19 Patients. | Incidence and Screening for Rhinocerebral Mucormycosis and its risk factors in patients with COVID-19: A Multicentric Combined Retrospective and Prospective Cohort Study. | | Dr Ujjwala Maheshwari | 16-08-2021 | 20210816 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56986 | Recruiting | No | | | | 01-09-2021 | 500 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Usha Asnani→ | | Department of Oral and Maxillofacial Surgery, Fourth Floor, MGM Medical College and Hospital, Kamothe, Sector 1, Navi Mumbai → | srivalli.shrikanth@gmail.com→ | 9769088803→ | MGM Dental College and Hospital Navi Mumbai→ | Inclusion criteria: 1) Age 18 years of age and above with or without Diabetes Mellitus. <br/ ><br>2) Participants diagnosed with covid-19 and being hospitalized and undergoing treatment for the same for the prospective group. <br/ ><br>3) Participants who have been deemed clinically recovered from COVID 19 and discharged up to 28 days prior to the commencement of participant recruitment for the retrospective group <br/ ><br>→ | Exclusion criteria: Participants who have succumbed to COVID-19 during the duration of study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B461- Rhinocerebral mucormycosis
→ | | To screen for Rhino Cerebral Mucormycosis and study the incidence of the same in patients with COVID 19. <br/ ><br>Timepoint: To screen for Rhino Cerebral Mucormycosis and study the incidence of the same in patients with COVID 19 at 2 weeks, 4 weeks and 6 weeks after discharge. <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/08/035701 | 7 September 2021 | COVID-19 Vaccine Hesitancy Among Bangladeshi Undergraduate University Students | Extent of COVID-19 Vaccine Hesitancy Among Bangladeshi Undergraduate University Students: A Cross-sectional Study | | Uttara Adhunik Medical College and Hospital | 16-08-2021 | 20210816 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59519 | | No | | | | 23-08-2021 | 3000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Bangladesh→ | Mohammad Ali→ | | Department of Physiotherapy and Rehabilitation, Room No-01 → | alibup2018@gmail.com→ | 01715043533→ | Uttara Adhunik Medical College and Hospital→ | Inclusion criteria: Currently enrolled University students in Bangladesh→ | Exclusion criteria: Not a current student→ | | | Prevalence of COVID-19 Vaccine HesitancyTimepoint: At the time of study→ | | | | Yes | False | | |
| → | CTRI/2021/08/035702 | 7 September 2021 | Comparison of invasive and non invasive methods of measuring blood oxygen in patients with COVID-19 infection. | Comparison of SpO2 and SaO2 in COVID-19 patients: A Cross-sectional Study | | Department of OncoAnaesthesia and Palliative Medicine | 16-08-2021 | 20210816 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50996 | Not Recruiting | No | | | | 20-08-2021 | 70 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Sushma Bhatnagar→ | | Room No. 242, Second floor, Dr BRAIRCH, All India Institute of Medical Science (AIIMS), Ansari Nagar, New Dehli → | khushboo0411@gmail.com→ | 9888530182→ | All India Institute of Medical Sciences, Ansari Nagar, New Delhi→ | Inclusion criteria: Laboratory confirmed cases of COVID-19 presenting on room air→ | Exclusion criteria: a) Patient refusal <br/ ><br>b) Weak peripheral pulses <br/ ><br>c) patients with signs or history of peripheral ischemia <br/ ><br>d) systolic blood pressure < 80 mmHg <br/ ><br>e) patients with respiratory distress (RR >24/min)→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | To compare relationship between SpO2 and SaO2Timepoint: on presentation to hospital (0 hours)→ | | | | Yes | False | | |
| → | CTRI/2021/08/035708 | 7 September 2021 | A Clinical Trail to know the Safety and Efficacy of Corovyl Tablet alongwith standard treatment in covid 19 positive patients. | A MULTI CENTRIC OPEN LABEL, RANDOMIZED, STUDY TO EVALUATE SAFETY AND EFFICACY OF
â??COROVYL TABLETâ??
USED AS IMMUNE BOOSTER, ANTI-COLD,
ANTI-INFLAMMATORY, BRONCHO PROTECTIVE,
IN THE MANAGEMENT OF CORONA VIRUS DISEASE
(COVID-19)
| | ZOTA Healthcare Ltd | 17-08-2021 | 20210817 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59241 | Not Recruiting | No | | | | 18-08-2021 | 30 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Outcome Assessor Blinded | Phase 2 | India→ | SKumar→ | | Room No 1 7H International M 71 Baludhyan Road
Uttamnagar
New Delhi
110059 → | 7hinternational@gmail.com→ | 9710719993→ | 7H International→ | Inclusion criteria: 2. Both male and female subjects will be included <br/ ><br>3. Positive or pharyngeal/nasal swab RT-PCR for Sars- Co- V2. Diagnosed not more than 2 daysago(diagnosis <br/ ><br> â?¤2days). <br/ ><br>4. Either asymptomatic or have mild to moderate symptoms. Onset of symptoms within no more than 4 days If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.â?¥18 to 60 С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) ( <30mg/L). There are no signs of dehydration, sepsis or shortness of breath. <br/ ><br>5. Signed informed consent/or consent given through text message, WhatsApp or e-mail. <br/ ><br>6. Ability to understand the requirements of the Research Protocol and follow the research procedures. <br/ ><br>7. Subject should be willing to be managed in isolation wards <br/ ><br>8. Negative pregnancy test (for female participants) <br/ ><br>9. Adequate contraception for study duration <br/ ><br>→ | Exclusion criteria: 2. Both male and female subjects will be included <br/ ><br>3. Positive or pharyngeal/nasal swab RT-PCR for Sars- Co- V2. Diagnosed not more than 2 daysago(diagnosis <br/ ><br> â?¤2days). <br/ ><br>4. Either asymptomatic or have mild to moderate symptoms. Onset of symptoms within no more than 4 days If symptomatic, symptoms are mild (cough, weakness, sore throat, low grade fever 38.â?¥18 to 60 С, respiratory rate should not be more than 22 / min, resting SpO2 >95%, normal highly sensitive C-reactive protein (HS-CRP) ( <30mg/L). There are no signs of dehydration, sepsis or shortness of breath. <br/ ><br>5. Signed informed consent/or consent given through text message, WhatsApp or e-mail. <br/ ><br>6. Ability to understand the requirements of the Research Protocol and follow the research procedures. <br/ ><br>7. Subject should be willing to be managed in isolation wards <br/ ><br>8. Negative pregnancy test (for female participants) <br/ ><br>9. Adequate contraception for study duration <br/ ><br>Exclusion criteria <br/ ><br>1. Less thanâ?¤18 to â?¥ 60 years <br/ ><br>2. With severe COVID-19 symptoms requiring immediate hospitalization <br/ ><br>3. Investigator considers the subject unsuitable forCOROVYL TABLET <br/ ><br>4. History of symptoms of more than4days <br/ ><br>5. COVID-19 diagnosed >2 days ago using or pharyngeal/nasal swab RT-PCR forSars-Co- V2 <br/ ><br>6. History of cardiopulmonary resuscitation <br/ ><br>7. Subjects having history of organ failure or conditions requiring ICU monitoring and treatment, such as severe liver disease, severe renal dysfunction, upper gastrointestinal hemorrhage, disseminated intravascular coagulation or any other condition that in the PIâ??s opinion makes the subject unfit to participate <br/ ><br>8. Respiratory failure, ARDS or need of mechanical ventilation <br/ ><br>9. History of acute exacerbation of co morbidity like heart failure, diabetic ketoacidosis, myocardial infection, major cardiac rhythm disorder or any other condition that in the PIâ??s opinion makes the subject unfit to participate <br/ ><br>10. History of or current hepatic failure or severely compromised liver function, or renal failure or having chronic kidney disease or acute renal failure <br/ ><br>11. History of or currently receiving treatment for an endocrine disorder like hypothyroidism, hyperthyroidism that is likely to affect the basal heart rate. <br/ ><br>12. History of or currently under treatment for asthma [exception: patients with history of asthma, not on medications/inhalers/nebulizers for at least 6 <br/ ><br>Months <br/ ><br> before study start), COPD, bronchiectasis, asbestosis and other such chronic lung conditions that can compromise SpO2 and RR. <br/ ><br>13. HIV, HBs Ag, HCV positive <br/ ><br>14. Any condition causing immunodeficiency <br/ ><br>15. Systemic connective tissue disease or any autoimmune disease that is likely to affect HS-CRP levels <br/ ><br>16. History of epilepsy/epileptic fit/convulsions in last 6 months or currently on treatment forit <br/ ><br>17. History of or currently having malignancy and being treated for it. (exception: histological confirmed and cured carcinoma insitu) <br/ ><br>18. Hypersensitivity reaction to Study drug/placebo <br/ ><br>19. Any psychiatric issue for which the subject is currently undergoing treatment <br/ ><br>20. Any history of drug/alcohol dependence within 30 days of screening or current drug/alcohol dependence <br/ ><br>21. Inability to understand the requirements of the Research Protocol and follow the research procedures. <br/ ><br>22→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J00-J99- Diseases of the respiratory system
→ | | 1 TTCI using NEWS Score Time Frame First treatment date up to discharge dayPIs discretion as per patients health condition <br/ ><br>The median time in days from the start of treatment with the study drugplacebo to the persistent achievement of all of the following criteria <br/ ><br>Stopping a fever which is defined as a decrease in axillary temperature below 37°C without the use of anti pyretic drugs <br/ ><br>Respiratory rate 22min <br/ ><br>Oxygen saturation SPO2 95% when breathing in atmospheric air Measured using pulseoximetry <br/ ><br>Systolic blood pressure 600mmHg <br/ ><br>Pulse rate5190beatsminute <br/ ><br>Is conscious and alert <br/ ><br>Note Persistent achievement means the preservation of each of the criteria for at least 7days <br/ ><br>2 TTIC using 7point ordinal scale <br/ ><br>3 Rate of progression to severecritical COVID19 disease based on NEWS score Time frame First treatment date up to15days <br/ ><br>Timepoint: Day 1 Day 7 Day 14→ | | | | Yes | False | | |
| → | CTRI/2021/08/035709 | 7 September 2021 | Effect of Vitamin D supplementation on immune response following COVID vaccine | Effect of Vitamin D supplementation on the immune repertoire in recipients of the ChAdOx1 nCoV- 19 vaccine: A prospective randomised, placebo-controlled trial | | SEHEAC New Delhi | 17-08-2021 | 20210817 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59515 | Not Recruiting | No | | | | 26-08-2021 | 400 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Participant and Outcome Assessor Blinded | Phase 3 | India→ | Dr Pinaki Dutta→ | | Department of Endocrinology, Room - 1012,
Nehru Extension Block,
PGIMER, Chandigarh → | drpinakidutta12@gmail.com→ | 9357114777→ | PGIMER, Chandigarh→ | Inclusion criteria: a)Adults enrolling for the 1st dose of COVISHIELD vaccine and consenting to participate <br/ ><br>b)Age between 18 to 60 years <br/ ><br>→ | Exclusion criteria: a)Pregnancy/Lactation <br/ ><br>b)Those on chronic glucocorticoid therapy ( >5mg/d in prior 3 months) <br/ ><br>c)HIV or other known immunodeficiency <br/ ><br>d)CKD/ESRD <br/ ><br>e)25(OH)D >30ng/ml at baseline <br/ ><br>f)IgG to spike protein >800mU/ml <br/ ><br>g)Malignancy/ Lymphoma <br/ ><br>h)Psychiatric illness <br/ ><br>i)Other immunosuppressive treatment <br/ ><br>j)Hypercalcemia ( >10.2mg/dl) <br/ ><br>k)Not consenting <br/ ><br>→ | | Intervention1: Calcifediol oral capsules: Calcifediol 50mcg oral capsules daily for 1 month<br>followed by 25mcg oral capsules daily for 6 months<br>Control Intervention1: Placebo capsules: Placebo capsules<br>→ | To evaluate the impact of calcifediol supplementation on the efficacy of ChAdOx1 nCoV- 19 vaccine in terms of both humoral and cell-mediated, anti-SARS-CoV-2 immunityTimepoint: Baseline, 3, 4 and 6 months from baseline→ | | | | Yes | False | | |
| → | CTRI/2021/08/035710 | 7 September 2021 | Will an online COVID-19 disaster simulation tabletop exercise improve the knowledge and confidence among interprofessional trainees | Impact of Virtual Interprofessional COVID-19 disaster simulation Tabletop Exercise (VICTEr) workshop on Disaster Preparedness among Interprofessional trainees in a tertiary care teaching hospital in India - VICTEry | | Dr Vimal Krishnan S | 17-08-2021 | 20210817 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57497 | Not Recruiting | No | | | | 30-08-2021 | 35 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Vimal Krishnan S→ | | Department of Emergency Medicine, Kasturba Medical College, Manipal → | vimal.krishnan@manipal.edu→ | 07907953224→ | Kasturba Medical College, Manipal→ | Inclusion criteria: All students (from the selected professions) consenting to be part of the study. The selected professions are medicine (MBBS), nursing (BSc Nursing), BSc RT (Respiratory therapy), BSc EMT (Emergency Medicine Technician) and dental (BDS) students who are in their final year/ internship.→ | Exclusion criteria: Non-availability of Consent.→ | | Intervention1: Virtual Interprofessional COVID-19 disaster simulation Tabletop Exercise module (VICTEr): Virtual training module which is 210 hours long<br>Intervention2: Virtual Interprofessional COVID-19 disaster simulation Tabletop Exercise module (VICTEr): Virtual training module which is 210 hours long<br>Control Intervention1: NIL: NIL<br>→ | Assess the baseline knowledge and confidence among interprofessional trainees on disaster preparedness <br/ ><br>Impact of the VICTEr module on Knowledge and confidence on disaster preparednessTimepoint: Baseline, 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/08/035732 | 7 September 2021 | Basti and Rasayan for Post COVID-19 Syndrome | Clinical Evaluation of Basti along with Rasayana on symptoms of Post COVID-19 Syndrome.Open Labelled Proof of Concept Pragmatic Study. | | Government Ayurved College and Hospital | 17-08-2021 | 20210817 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59049 | Not Recruiting | No | | | | 15-09-2021 | 24 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Payal Rathod→ | | Department of Kayachikitsa,OPD number 1, Government Ayurved College and Hospital,Nagpur. → | amitnakanekar@gmail.com→ | 9850233016→ | Government Ayurved College,Nagpur→ | Inclusion criteria: â?¢ Patients of Post COVID-19 Syndrome came under duration of >21 days to 1 year after RTPCR report <br/ ><br>â?¢ Patient of either sex aged between 18-70 years. irrespective of caste, religion , socio economic and educational status. <br/ ><br>â?¢ Patient of Post COVID-19 Syndrome having > 20 % ( > 4) of symptoms will be included for the study. <br/ ><br>â?¢ Patient of Post COVID-19 Syndrome who are willing to participate in trial and ready to give written consent. <br/ ><br>→ | Exclusion criteria: â?¢ Patients with serious lifethreatening diseases and critically ill patients of Post COVID-19 Syndrome will be excluded. <br/ ><br> <br/ ><br>â?¢ Pregnant females and lactating mothers will not be considered for study. <br/ ><br> <br/ ><br>â?¢ Basti Anarhya will be excluded for study. <br/ ><br> <br/ ><br>â?¢ Patient who have known hypersensitivity reactions to medicines mentioned in the study will be excluded. <br/ ><br> <br/ ><br>â?¢ Any other patient which investigator feels not to be included will be excluded from study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | | 1. To evaluate the efficacy of Triphala Kwath Niruh Basti, Tiltail Anuvasan Basti and Brahma Rasayana on symptoms of Santarpanottha Post COVID-19 Syndrome in period of 35 days. <br/ ><br> <br/ ><br>2. To evaluate the efficacy of Brihatpanchmulsidhha Kshirbasti ,Kshirbala tail Anuvasan Basti and Kalyanak Ghrit on symptoms Apatarpanottha Post COVID-19 Syndrome period of 35 days. <br/ ><br> <br/ ><br>3. To compare symptoms of Santarpanottha and Apatarpanottha Post COVID-19 Syndrome at the time of recruitment. <br/ ><br>Timepoint: 18 month <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/08/035736 | 7 September 2021 | Spirometry in rehabilitation of severe COVID-19 patients- a randomised controlled trial | Role of Incentive Spirometry in pulmonary rehabilitation of
severe COVID-19 patients- an open label randomised
controlled trial - RISE COVID | | Dr Animesh Ray | 17-08-2021 | 20210817 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59357 | Not Recruiting | No | | | | 01-09-2021 | 75 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | Phase 2/ Phase 3 | India→ | Dr Ayush Agarwal→ | | Medicine office,Department of Medicine,
3rd floor teaching block,
All India Institute of Medical Sciences,
New Delhi → | doctoranimeshray@gmail.com→ | 01126593963→ | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: a) Aged at least 18 years <br/ ><br>b) Hospitalised <br/ ><br>c) Confirmed SARS-CoV-2 infection by nucleic acid based testing (RT-PCR, CB-NAAT, or TrueNAT) or antigen testing <br/ ><br>d) Moderate and severe COVID-19 pneumonia (SpO2 <94%) <br/ ><br>e) Decreasing supplemental oxygen requirements (Nasal prongs â?¤6 L/min) <br/ ><br>f) Hemodynamically stable <br/ ><br>g) Cooperative <br/ ><br>h) No medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial <br/ ><br>→ | Exclusion criteria: a) MMSE <24 <br/ ><br>b) Recent surgery, cardiovascular event (ACS, PE) <br/ ><br>c) Moderate-severe heart disease (NYHA grade III or IV) <br/ ><br>d) CLD with ascites <br/ ><br>e) Prior history of TB, COPD, asthma, ILD <br/ ><br>f) Pregnant and lactating women <br/ ><br>g) Difficulty in mobilisation (for 6MWT) <br/ ><br>h) Hemodynamically unstable <br/ ><br>i) Refusal of consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Volume oriented spirometer: Through the volume oriented spirometer, patients will be instructed to inspire slowly and deeply till the yellow indicator on the piston reaches blue outlined area and then hold breath for as long as possible and then exhale slowly. The participants will do 3 sessions per day with 2 repetitions in each session. Each repetition consists of 10 breaths followed by brief rest of normal breathing for 1 minute. This will be continued for 1 month post discharge.<br>Intervention2: Flow oriented spirometer: Using flow oriented spirometer, patients will be instructed to inspire slowly and deeply till the lifting of atleast 2 balls and then hold breath for as long as possible and then exhale slowly. The participants will do 3 sessions per day with 2 repetitions in each session. Each repetition consists of 10 breaths followed by brief rest of normal breathing for 1 minute This will be continued for 1 month post discharge.<br>Control Intervention1: Deep breathing exercise using Anulom Vilom: In it, participants will inhale slowly through right nostril closing the left nostril, exhale fully through the left one closing the other one, repeat this in cyclic manner. The mouth shall remain closed. The participants will do 3 sessions per day with 2 repetitions in each session. Each repetition consists of 10 breaths followed by brief rest of normal breathing for 1 minute. This will be continued for 1 month post discharge.<br>→ | Degree of improvement in respiratory parameters as measured by S. George Respiratory questionnaire (SGRQ), 6 minute walk test (6MWT), mMRC dyspnea scale and single breath count.Timepoint: At discharge, 2 weeks, 1 month and 3 months→ | | | | Yes | False | | |
| → | CTRI/2021/08/035745 | 7 September 2021 | Immuno -Modulatory Potential of AyurRaksha Kit and Its Preventive Impact on COVID 19 In Delhi Police | â??evaluation of the Immuno Modulatory Potential of AyurRaksha Kit On a Cohort of Delhi Police to Assess Prophylactic Impact on COVID 19 - An Exploratory Studyâ?? | | Ministry of AYUSH | 18-08-2021 | 20210818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58908 | Not Recruiting | No | | | | 20-08-2021 | 2000 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment: Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Sujata Kadam→ | | Dean office ,Academic block,Ground floor,All india institute of Ayurveda,Gautam puri Awas,Sarita Vihar ,New Delhi-110076 → | dr.ananthramsharma@gmail.com→ | 9495130595→ | All India Institute of Ayurveda→ | Inclusion criteria: 1.Police personnel of either sex aged 19-60 years <br/ ><br>2.Delhi Police personnel on duty in different units and from 4 districts of Delhi state. <br/ ><br>3.Individuals agree to give consent for participation <br/ ><br>→ | Exclusion criteria: 1.Police personnelâ??s with severe co morbidities <br/ ><br>2.Those who are on any other prophylaxis <br/ ><br>3.Those who are presently infected with Covid-19 <br/ ><br>→ | | | 1. Baseline survey would generate information on occurrence of covid19 infection during past 4 months (as reference time) and related epidemiological determi-nants. <br/ ><br>2 AS the cohort of susceptible persons is followed after giving prophylactic medi-cines, the observance of new covid19 infection as incidence. Incidence will be counted after the 15 days of intake of medicine. <br/ ><br>3 Among those covid19 positive found, would be observed for progress in recov-ery and disease severity. <br/ ><br>4 The change in immunity status as measured by ISQ would be as-sessed <br/ ><br>Timepoint: assessed at baseline, after 60days, and <br/ ><br>after 120 days.→ | | | | Yes | False | | |
| → | CTRI/2021/08/035747 | 7 September 2021 | Clinical Trial Using Health Drink | To evaluate safety of Mulmina Health Drink between two doses of COVID-19 Vaccine | | Juggat Pharma | 18-08-2021 | 20210818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53415 | Not Recruiting | No | | | | 20-09-2021 | 300 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable | N/A | India→ | Dr Shashidhar K N→ | | Professor and HoD, Department of Biochemistry, RL Jalappa Hospital and Research Centre attached to Sri Devaraj Urs Medical College, SDUAHER → | drshashikn1971@yahoo.co.in→ | 9845248742→ | Sri Devaraj Urs Medical College→ | Inclusion criteria: Subjects who meet the following criteria will be included in the study: <br/ ><br>ï?¼ Males and females >18 and <65 years of age <br/ ><br>ï?¼ Subjects willing to consume Mulmina energy drink regularly: 2 Tetra Packs of 200 mL each per day for 28 days <br/ ><br>→ | Exclusion criteria: Subjects who meet the following criteria will be excluded from the study: <br/ ><br>ï?¼ Pregnant or lactating women <br/ ><br>ï?¼ Any acute gastrointestinal disease within 2 weeks prior to study entry <br/ ><br>ï?¼ Cancer cachexia <br/ ><br>ï?¼ Patients suffering from chronic illness <br/ ><br>ï?¼ Untreated major psychiatric disorder <br/ ><br>ï?¼ Known HIV positive <br/ ><br>ï?¼ Hepatitis B & C <br/ ><br>→ | | Intervention1: Mulmina a multi- mineral and multi- vitamin health drink: 2 tetra packs of 200 mL each per day for 28 days between 1st and 2nd dose of Covid- 19 vaccine<br>Control Intervention1: Healthy Controls: Not on either Mulmina mango or Mulmina orange but vaccinated with 1st dose of Covishield vaccine<br>→ | Change in COVID 19 Antibodies & Immune markers level after consumption of Mulmina health drinkTimepoint: Zero Day Screening and Baseline <br/ ><br>Twenty eighth day Laboratory analysis→ | | | | Yes | False | | |
| → | CTRI/2021/08/035755 | 7 September 2021 | Comparative study of Ashwagandha for its effect on quality of life in patients during post-COVID19 period | Evaluation of Ashwagandha (Withania Somnifera) Standardized Extract for its effect on quality of life (QoL) in patients during post-COVID19 period: A Prospective, Randomized, Placebo-Controlled Study | | D Y Patil Medical College Hospital and Research Center | 18-08-2021 | 20210818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59449 | Not Recruiting | No | | | | 21-08-2021 | 60 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Pre-numbered or coded identical Containers Blinding and masking:Participant and Investigator Blinded | N/A | India→ | Dr Deepak Langade→ | | Department of Pharmacology 5th floor D Y Patil UNiversity School of Medicine & Hospital Sector-5, Nerul, Navi Mumbai Thane MAHARASHTRA → | deepak.langade@dypatil.edu→ | | D Y Patil Medical College, Hospital and Research Center→ | Inclusion criteria: 1. Subjects of either gender, aged 18 to 50 years <br/ ><br>2. All adult patients aged â?¥18 years who present to the site for follow-up OPD <br/ ><br>3. Laboratory-confirmed COVID-19 infection with SARS-CoV-2 <br/ ><br>4. Patients who agree to follow-up for up to three months. <br/ ><br>5. Subjects able to understand and complete the study questionnaires <br/ ><br>6. Subjects who sign the informed written consent→ | Exclusion criteria: 1. Patients aged below 18 years will be excluded. <br/ ><br>2. Unwilling or unable to provide written informed consent, <br/ ><br>3. Pregnant or breast-feeding women or women with positive urinary pregnancy test at screening. <br/ ><br>4. Those who cannot be relied upon to comply with the test procedures or are unwilling to give <br/ ><br>informed consent→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Test Product: KSM 66 Ashwagandha Capsule (300 mg), twice a day for 12 weeks<br>Control Intervention1: Control Product: 300 mg Placebo capsule identical to KSM 66 Ashwagandha but without active ingredients, twice a day for 12 weeks<br>→ | Change in the health summary scores from Short Form SF-36 Quality of life (SF-36 QoL)questionnaire at the end of 12 weeksTimepoint: screening, week 4, week 8 and week 12→ | | | | Yes | False | | |
| → | CTRI/2021/08/035756 | 7 September 2021 | Follow Up Study to Evaluate the Pharmacotherapy of Covid-19 Patients in The Tertiary Care Hospital | A Prospective, Interventional, Cross-Sectional, Follow Up Study to Evaluate the Pharmacotherapy of Covid-19 Patients in The Tertiary Care Hospital. | | Adichunchanagiri University | 18-08-2021 | 20210818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59176 | Recruiting | No | | | | 22-08-2021 | 202 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr RAVI K S→ | | ENT OPD
Ground floor
Room no 096 → | dryogendrastha@gmail.com→ | 7348944358→ | Sri Adichunchanagiri College of Pharmacy Adichunchanagiri University→ | Inclusion criteria: Diagnosed with Covid-19 by any diagnostic tool (i.e., RT-PCR, CT scan or X-Ray and any other as per the clinical decision taken by the treating physician). <br/ ><br>→ | Exclusion criteria: Those who does not meet inclusion criteria.→ | Health Condition 1: J80- Acute respiratory distress syndrome
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Pharmacotherapy evaluation: Our study is mainly focus on patient safety <br>Intervention is in the pharmaceutical care where dose, duration of therapy, frequency, medical adherence and therapeutic drug monitoring come in the picture.<br>Intervention2: Nil: Nil<br>Control Intervention1: No applicable: No applicable<br>→ | This study can help in rationalization, individualization of drug therapy. <br/ ><br> The study minimizes the chance of treatment failure and drug related complications. <br/ ><br> The study can suggest the alternative drugs during drug shortage. <br/ ><br> This study can prevent the possible drug-drug interaction. <br/ ><br>Timepoint: <br/ ><br>3 years→ | | | | Yes | False | | |
| → | CTRI/2021/08/035758 | 7 September 2021 | A Study to Explore the Long-Term Consequences in Covid-19 Recovered Individual. | An Ambidirectional, Descriptive, Follow-Up, Cohort Study to Explore the Long-Term Consequences in Covid-19 Recovered Individual. | | Adichunchanagiri University | 18-08-2021 | 20210818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59489 | Recruiting | No | | | | 22-08-2021 | 202 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Yogendra Shrestha→ | | Clinical Trial Center
2nd floor
Room no 001
AH and RC
BG Nagara
→ | dryogendrastha@gmail.com→ | 7348944358→ | Sri Adichunchanagiri College of Pharmacy Adichunchanagiri University→ | Inclusion criteria: All the individual of both genders of age â?¥18 years. <br/ ><br>COVID-19 survivors with a uniform revised discharge policy for Covid-19 according to Ministry of Health and Family Welfare, Government of India. <br/ ><br>All the individual who will give a consent. <br/ ><br>→ | Exclusion criteria: Any COVID-19 patient who does not have a uniform revised discharge policy for Covid-19 according to Ministry of Health and Family Welfare, Government of India.24 <br/ ><br>Any COVID-19 survivors with a history of psychiatric illness, tuberculosis and human immunodeficiency virus (HIV) syndrome. <br/ ><br>An individual not willing to come for follow-up. <br/ ><br>→ | | Intervention1: Not Applicable: Not Applicable<br>Control Intervention1: Not Applicable: Not Applicable<br>→ | This study can assess long-term consequences in Covid-19 recovered individuals. <br/ ><br>This study helps in early detection and address of health-related problems associated to and Covid-19 recovered individuals. <br/ ><br> <br/ ><br>Timepoint: 3 years <br/ ><br> <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/08/035760 | 7 September 2021 | Online Mindfulness influences Stress, Anxiety and Depression in an Indian community | An Online Mindfulness-based intervention influences Stress, Anxiety and Depression in an Indian community during the COVID-19 Pandemic: A Prospective Randomized Controlled Study | | Anirban Pal | 18-08-2021 | 20210818 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59589 | Not Recruiting | No | | | | 01-09-2021 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Anirban Pal→ | | 48/1F, Leela Roy Sarani → | pal.anirban1@gmail.com→ | | Apollo Medical center→ | Inclusion criteria: informed consent obtained→ | Exclusion criteria: → | | Intervention1: Mindfulness-based Intervention: Mindfulness involves group sessions using breathing exercise and relaxation techniques for a period of 4 weeks.<br>Control Intervention1: Placebo session: Similar sessions for 4 weeks duration but the concept of Mindfulness excluded in those sessions<br>→ | Stress, Anxiety, DepressionTimepoint: 4 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/08/035805 | 7 September 2021 | Our experience on clinical outcomes of COVID-19 diabetic patients after sequential oxygen therapy in tertiary medical college. | Our Experiences on clinical outcomes of COVID-19 diabetic patients after sequential oxygen therapy in tertiary medical college. | | Dr D Y Patil Medical College Hospital and Research Centre Pune | 19-08-2021 | 20210819 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=49153 | Not Recruiting | No | | | | 06-09-2021 | 150 | Observational | Other<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Outcome Assessor Blinded | N/A | India→ | Dr C M Suryawanshi→ | | Department of Anaesthesiology
Dr. D.Y. Patil Medical college, hospital and research centre. Sant tukaram nagar. Pimpri. Pune → | chhayasuryawanshi@gmail.com→ | 9922888201→ | Dr. D.Y.Patil Medical college hospital and research centre Pune→ | Inclusion criteria: 1)Patients diagnosed with COVID-19 <br/ ><br>2) Patients with type 2 Diabetes mellitus <br/ ><br>3)Willing to sign the informed consent voluntarily <br/ ><br>→ | Exclusion criteria: 1)Pregnant, Cognitive and Mental disorder patients. <br/ ><br>2)Any known lung pathology like active tuberculosis, Bronchial asthma, Bronchiectasis, Pulmonary embolism, Chronic respiratory failure and other serious respiratory disorder. <br/ ><br>3)Cigarette smokers <br/ ><br>4)Obese patients.(BMIâ?¥30) <br/ ><br>5)Cardiovascular, cerebrovascular and hepatorenal disease. <br/ ><br>6)Elderly, immunocompromised and Carcinoma patients <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Control Intervention1: Not Applicable: Not applicable<br>→ | Escalation of oxygen requirement on 5th, 10th and 15th day in each oxygen therapy.Timepoint: 2 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/08/035815 | 7 September 2021 | A Clinical Study Know the efficacy of Ayurveda Medicines in COVID 19 Positive Patients | An open label controlled clinical study to evaluate the efficacy of Ayurveda Medicines - Sudarshana churna, Yestimadhu churna and Amrtharista as add on therapy on Symptomatology, Inflammatory Markers and RT-PCR in positive cases of COVID-19 - A Collaborative Study | | Central Council for Research in Ayurvedic Sciences | 19-08-2021 | 20210819 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58706 | Not Recruiting | No | | | | 01-09-2021 | 52 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 4 | India→ | Dr Kishore Kumar Ramakrishna→ | | Department of Integrative Medicine, National Institute of Mental Health and Neurosciences, Bengaluru. → | ayurkishore@gmail.com→ | 09845829174→ | National Institute of Mental Health and Neurosciences→ | Inclusion criteria: 1) Patients positive for COVID 19 confirmed by RT-PCR. <br/ ><br>2) Patients with mild to moderate symptoms (NEWS 2 criteria).→ | Exclusion criteria: Patients with <br/ ><br>1) Diabetes Miletus. <br/ ><br>2) Hepatic dysfunction <br/ ><br>3) Renal dysfunction <br/ ><br>4) Pulmonary dysfunction <br/ ><br>5) Cardiovascular disease <br/ ><br>6) Debilitating Neurological disorders. <br/ ><br>7) Psychiatric illness. <br/ ><br>8) Pregnant and Lactating. <br/ ><br>9) Oxygen saturation less than 90%. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
→ | | Changes in <br/ ><br>1) COVID 19 Symptomatology. <br/ ><br>2) RT-PCR <br/ ><br>3) IL-6Timepoint: 2 weeks→ | | | | Yes | False | | |
| → | CTRI/2021/08/035819 | 7 September 2021 | Development of Faculty Belief and Perception Towards E-Learning (FBPTE) as a questionnaire for measuring experiences of faculty about online teaching during COVID-19 times | Developing and establishing the psychometric properties of Faculty Belief and Perception Towards E-Learning (FBPTE) as a tool of measuring faculty experiences during COVID-19 times - FBPTE | | NIL | 19-08-2021 | 20210819 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59077 | Not Recruiting | No | | | | 01-09-2021 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Tarushi Tanwar→ | | Room No - 205
Centre for Physiotherapy and Rehabilitation Sciences
Jamia Millia Islamia Jamia Nagar
Okhla
New Delhi→ | iram.physio@gmail.com→ | | Jamia Millia Islamia→ | Inclusion criteria: Faculty members using online means for teaching in accordance with UGC guidelines and having working knowledge (written and verbal) of English language in order to complete the questionnaires and sign the informed consent.→ | Exclusion criteria: Participants on medication for any diagnosed psychiatric diseases/disorders. <br/ ><br>Inability or unwillingness to complete questionnaire independently.→ | | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br>→ | Faculty Belief and Perception Towards E-LearningTimepoint: Data will be collected only once, i.e., at only one point of time when the participants will be provided the scale to be filled for collection of data.→ | | | | Yes | False | | |
| → | CTRI/2021/08/035822 | 7 September 2021 | Assessment of doubling dose of dexamethasone in progressively worsening severe COVID-19 pneumonia - a randomized controlled trial | Assessment of doubling dose of dexamethasone in progressively worsening severe COVID-19 pneumonia not responding to standard dose - an open-label pragmatic randomized controlled trial - ADDED | | Animesh Ray | 19-08-2021 | 20210819 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57048 | Not Recruiting | No | | | | 01-09-2021 | 120 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Open Label | Phase 3 | India→ | Dr Satish Swain→ | | Medicine office,Department of Medicine,
3rd floor teaching block,
All India Institute of Medical Sciences,
New Delhi-110029 → | doctoranimeshray@gmail.com→ | 01126593963→ | All India Institute of Medical Sciences, New Delhi→ | Inclusion criteria: Patients aged at least 18 years, hospitalised, confirmed SARS-CoV-2 infection by nucleic acid based testing (RT-PCR, CB-NAAT, or TrueNAT) or antigen testing, Severe COVID-19 pneumonia (SpO2 <94%; PaO2/FiO2 <300 mm Hg or respiratory rate(RR) >30 breaths/min) with lack of response to Dexamethasone 6 mg after 48 hours [defined as similar or worsening oxygen requirement (margin of error is 5% Fio2 for high flow nasal cannula, 2 L/min for NRBM, and 1 L/min for low flow oxygen devices)] <br/ ><br>→ | Exclusion criteria: Patient already on corticosteroid therapy for an unrelated indication; Patient with impending death or respiratory failure necessitating ICU care within 24 hours including inability to maintain SpO2 â?¥90% despite HFNC with flow 60 L/min and FiO2 1.0 or ,if available, NIV with PEEP of upto 8 cm H2O and FiO2 1.0; Patients who have received â?¥2 day of steroids outside hospital care or within the hospital outside of wards that are involved in the study. These doses must be no greater than 12 mg dexamethasone or 64 mg methylprednisolone cumulatively; Patients with a known contraindication to corticosteroids including untreated bacterial sepsis, diabetic keto-acidosis, and invasive fungal infections such as mucormycosis; medical history that might, in the opinion of the attending clinician, put the patient at significant risk if he/she were to participate in the trial; Pregnancy; Recruitment in another therapeutic trial; Use of immunosuppressive drugs, cytotoxic chemotherapy in the past 21 days; Neutropenia due to hematological or solid malignancies with bone marrow invasion; Refusal of consent. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Dexamethasone 12 mg: Dexamethasone 12 mg, once daily, through intravenous or oral route, for 10 days or till day of discharge, whichever is earlier.<br>Control Intervention1: Dexamethasone 6 mg: Dexamethasone 6 mg, once daily, through intravenous or oral route, for 10 days or till discharge, whichever is earlier<br>→ | Supplemental oxygen-free days at day 28 from hospitalization <br/ ><br>Proportion of patients requiring non-invasive ventilation by NIV mask or invasive mechanical ventilationTimepoint: Day 28 from hospitalisation, during hospital course→ | | | | Yes | False | | |
| → | CTRI/2021/08/035843 | 7 September 2021 | Impact of COVID- 19 on Sports Physiotherapy Practice Patterns in India | Challenges and Adaptations to Sports Physiotherapy Practice due to COVID-19 Pandemic in India: A Survey | | Garima Gaur | 23-08-2021 | 20210823 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59261 | Not Recruiting | No | | | | 31-08-2021 | 385 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Prateek Srivastav→ | | Department of Physiotherapy, 2nd Floor, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal → | prateek.srivastav@manipal.edu→ | 8971984556→ | Department of Physiotherapy, Manipal College of Health Professions→ | Inclusion criteria: Sports physiotherapists practicing in India associated with all sports categories.→ | Exclusion criteria: Sports physiotherapists with less than 3 years of experience.→ | | Intervention1: NIL: NIL<br>→ | Changes made in sports physiotherapy practices pre-, during, and post-lockdown due to COVID-19 pandemic in India.Timepoint: As it is a survey, the questionnaire will be administered only once, at the baseline.→ | | | | Yes | False | | |
| → | CTRI/2021/08/035885 | 7 September 2021 | Perception of COVID-19 vaccines among adults in Tamil Nadu: a survey | Perception of COVID-19 vaccines among adults in Tamil Nadu: a survey - COVID-19 VACCINE SURVEY | | SRM University | 24-08-2021 | 20210824 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59243 | Not Recruiting | No | | | | 30-08-2021 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | R BILLY GRAHAM→ | | Room No: 381, DEPARTMENT OF CLINICAL PHARMACOLOGY, SRM MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTER, KATTANKULATHUR, CHENNAI → | melvingeorge2003@gmail.com→ | 9894133697→ | SRM MCH and RC→ | Inclusion criteria: 1. Age 18 to 80 years of either gender <br/ ><br>2. Both vaccinated and non-vaccinated adults <br/ ><br>3. Adults with or without history of COVID-19 infection. <br/ ><br>4. Participants resident of Tamil Nadu for at lest 2 years.→ | Exclusion criteria: 1. Those are not willing to participate in the study <br/ ><br>2. Below 18 age participants <br/ ><br>3. Participants who are from other states of India.→ | | Intervention1: NIL: NIL<br>→ | â?¢ Proportion of adults with hesitancy towards COVID-19 vaccines. <br/ ><br>â?¢ Evaluation of factors contributing towards vaccine hesitancy among the adultâ??s in Tamil Nadu. <br/ ><br>Timepoint: Baseline→ | | | | Yes | False | | |
| → | CTRI/2021/08/035905 | 7 September 2021 | Arsenicum album 200C in preventing COVID 19 respiratory illness and ILI | Effectiveness of Arsenicum album 200C in preventing COVID 19 like respiratory illness and Influenza-like illness in dwellers of urban slum: A Prospective Cohort study | | Central Council for Research in Homoeopathy | 24-08-2021 | 20210824 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59794 | Not Recruiting | No | | | | 31-08-2021 | 12000 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Debadatta Nayak→ | | Room No-303
Central Council for Research in Homoeopathy
61-65, Institutional area
Janakpuri → | drdnayak@gmail.com→ | 09873404012→ | Central Council for Research in Homoeopathy→ | Inclusion criteria: 1. Healthy individuals living in the same community <br/ ><br>2. Written Informed consent by head of the family <br/ ><br>3. No symptom of Influenza like illness/COVID-19 at the time of enrolment.→ | Exclusion criteria: 1. Individuals with symptoms of Influenza like illness/ COVID-19 in last 14 days <br/ ><br>2. Pregnant women and lactating mother <br/ ><br>3. Child below age of 1 year. <br/ ><br>4. Individuals taking other homoeopathic medicines for prevention of Influenza like <br/ ><br>illness/COVID-19 <br/ ><br>5. Patients with malignancy, immunocompromised state, life threatening diseases, end stage <br/ ><br>diseases.→ | | Intervention1: Homoeopathic medicine Arsenicum album 200C: Homoeopathic medicine Arsenicum album 200C shall be given to apparently health individuals. Dose for children below 5 years: 2 pills of medicine Arsenicum album 200C once every 02 weeks.<br>Dose for individuals 5 yrs or above: Give 4 pills of medicine Arsenicum album 200C once every 02 weeks.<br>Control Intervention1: Information, education, communication about prevention of influenza like illness and COVID-19: Information, education,communication about prevention of influenza like illness and COVID-19<br>→ | Incidence of Influenza-like illness & COVID-19 type respiratory illness.Timepoint: Weekly till completion of 1 year→ | | | | Yes | False | | |
| → | CTRI/2021/08/035906 | 7 September 2021 | Nanocurcumin (6C & 30C) on incidence of ILI & COVID-19 type respiratory illness | Effectiveness of Nanocurcumin (6C & 30C) on incidence of
Influenza-like illness & COVID-19 type respiratory illness in urban slum dwellers â?? A Longitudinal study | | Central Council for Research in Homoeopathy | 24-08-2021 | 20210824 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59828 | Not Recruiting | No | | | | 31-08-2021 | 17000 | Interventional | Non-randomized, Active Controlled Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India→ | Dr Debadatta Nayak→ | | Epidemic Cell
Room No-303
61-65, Sewa Marg, Opp D Block, Institutional Area, Janakpuri, New Delhi, Delhi 110058 → | drdnayak@gmail.com→ | 09873404012→ | CCRH→ | Inclusion criteria: 1. Healthy individuals living in the same community <br/ ><br>2. Written Informed consent by head of the family <br/ ><br>3. No symptom of Influenza like illness/COVID-19 at the time of enrolment.→ | Exclusion criteria: 1. Individuals with symptoms of Influenza like illness/ COVID-19 in last 14 days <br/ ><br>2. Pregnant women and lactating mother <br/ ><br>3. Child below age of 1 year. <br/ ><br>4. Individuals taking other homoeopathic medicines for prevention of Influenza like <br/ ><br>illness/COVID-19 <br/ ><br>5. Patients with malignancy, immunocompromised state, life threatening diseases, end <br/ ><br>stage diseases.→ | | Intervention1: Nanocurcumin-6C: Dose for children below 5 years: 2 pills of medicine Nanocurcumin 6C once in every week for first 2 months, followed by once in 2 weeks.<br>â?¢ Dose for individuals 5 yrs or above: 4 pills of medicine Nanocurcumin 6C once in every week for first 2 months, followed by once in 2 weeks.<br>Intervention2: Nanocurcumin-30C: Dose for children below 5 years: 2 pills of medicine Nanocurcumin 6C once in every week for first 2 months, followed by once in 2 weeks. â?¢ Dose for individuals 5 yrs or above: 4 pills of medicine Nanocurcumin 6C once in every week for first 2 months, followed by once in 2 weeks.<br>Intervention3: Nanocurcumin-30C: Dose for children below 5 years: 2 pills of medicine Nanocurcumin 6C once in every week for first 2 months, followed by once in 2 weeks. â?¢ Dose for individuals 5 yrs or above: 4 pills of medicine Nanocurcumin 6C once in every week for first 2 months, followed by once in 2 weeks.<br>Intervention4: Nanocurcumin-30C: Dose for children below 5 years: 2 pills of medicine Nanocurcumin 6C once in every week for first 2 months, followed by once in 2 weeks. â?¢ Dose for individuals 5 yrs or above: 4 pills of medicine Nanocurcumin 6C once in every week for first 2 months, followed by once in 2 weeks.<br>Intervention5: Nanocurcumin-30C: Dose for children below 5 years: 2 pills of medicine Nanocurcumin 6C once in every week for first 2 months, followed by once in 2 weeks. â?¢ Dose for individuals 5 yrs or above: 4 pills of medicine Nanocurcumin 6C once in every week for first 2 months, followed by once in 2 weeks.<br>Intervention6: Nanocurcumin-30C: Dose for children below 5 years: 2 pills of medicine Nanocurcumin 6C once in every week for first 2 months, followed by once in 2 weeks. â?¢ Dose for individuals 5 yrs or above: 4 pills of medi→ | Incidence of Influenza-like illness & COVID-19 type respiratory illness.Timepoint: Weekly till completion of 1 year.→ | | | | Yes | False | | |
| → | CTRI/2021/08/035908 | 7 September 2021 | A clinical study TO evaluate the efficacy of AYUSH drug on Covid 19 patients | A clinical study on the efficacy of NF1 AND NF3 IN THE TREATMENT OF COVID 19 POSITIVE PATIENTS ALONG WITH STANDARD CARE | | Sri Sri Institute for advanced research Begaluru Karnataka | 25-08-2021 | 20210825 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59162 | Not Recruiting | No | | | | 01-09-2021 | 100 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Alternation Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | Dr Sanjib Kumar Das→ | | Deptt of Kayachikitsa Ayurveda DIvision Room No C03 Sri Sri College of Ayurvedic Science and Research Hospital Sri Sri University Cuttack Odisha Deptt of Kayachikitsa Ayurveda DIvision Room No C03 Sri Sri College of Ayurvedic Science and Research Hospit→ | ayursanjib@gmail.com→ | 9437292457→ | Sri Sri College of Ayurvedic Science and Research Hospital→ | Inclusion criteria: History of fever <br/ ><br>Cough <br/ ><br>Willingness to participate in the study <br/ ><br>Patient should be ready to give written consent <br/ ><br>Indian Nationals→ | Exclusion criteria: Age less than 18 years or more than 65 years <br/ ><br>Pregnancy and Lactation <br/ ><br>T2DM <br/ ><br>CVS disorders <br/ ><br>Renal Problems(CKD) <br/ ><br>COPD <br/ ><br>Bronchial Asthma <br/ ><br>Malignancy <br/ ><br>CVA→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | RTPCR NEGATIVE <br/ ><br>Reducing the signs and symptoms and changes in biomarkersTimepoint: Day5 <br/ ><br>Day10→ | | | | Yes | False | | |
| → | CTRI/2021/08/035909 | 7 September 2021 | Anti-Coronavirus Therapies (ACT) | Anti-Coronavirus Therapies(ACT)to prevent progression of mild COVID-19 : Randomized Trials - ACT | | Population Health Research Institute | 25-08-2021 | 20210825 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=45499 | Not Recruiting | No | | | | 01-09-2021 | 2500 | Interventional | Randomized Factorial Trial<br> Method of generating randomization sequence:Permuted block randomization, variable Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3 | India;Brazil;Canada;Colombia;Ecuador;Egypt;Nepal;Philippines;Russian Federation;South Africa;United Arab Emirates→ | Dr Atiya Faruqui→ | | St. Johns Medical College and Research and Training St. Johns Research Institute St. Johns National Academy of Health Sciences Bangalore 560 034, India
Bangalore
KARNATAKA
560 034
India → | pais.prem@gmail.com→ | 08049467005→ | St. Johns Research Institute St. Johns National Academy of Health Sciences→ | Inclusion criteria: 1) Symptomatic and RTPCR positive confirmed diagnosis of mild COVID-19. Mild disease is defined as per Government of India guidelines as follows: <br/ ><br>â?¢ Patients with uncomplicated upper respiratory tract infection, may have mild symptoms such as fever, cough, sore throat, nasal congestion, malaise, headache. <br/ ><br>â?¢ Without evidence of breathlessness or hypoxia (normal saturation) <br/ ><br>â?¢ Managed at COVID care center (or quarantined at home as per revised guidelines for home isolation: https://www.mohfw.gov.in/pdf/RevisedHomeIsolationGuidelines.pdf). <br/ ><br>2) Age â?¥18 years. <br/ ><br>3) High risk: either age â?¥70 or at least one of the following: male; obesity (BMI â?¥30); chronic cardiovascular, respiratory or renal disease; active cancer; diabetes). <br/ ><br>4) Within 7 days (ideally 72 hours) of diagnosis, or worsening clinically. <br/ ><br> <br/ ><br>Additional details: <br/ ><br>â?¢ The patients need to be recruited from fever clinic or from the hospitalâ??s community care center. <br/ ><br>â?¢ Baseline lab tests for blood count and serum creatinine to confirm eligibility need to be done <br/ ><br>â?¢ Height and weight should be assessed at the time of recruitment <br/ ><br> <br/ ><br>→ | Exclusion criteria: 1) Kidney disease (eGFR <15 mL/min/1.73m2); liver disease; pregnancy or lactation. <br/ ><br>2) Colchicine: allergy or planned use; current or planned use of cyclosporine, verapamil, HIV protease inhibitor, systemic azole antifungal, or macrolide antibiotic (except azithromycin). <br/ ><br>3) Aspirin: allergy or planned use; high risk of bleeding, current or planned use of other anti-thrombotic drugs (e.g., P2Y12 inhibitors, direct oral anticoagulants, vitamin K antagonists, heparins). <br/ ><br>4)(Patients >70 years, with known chronic kidney disease, or with a history of diabetes for more than 10 years should get creatinine [eGFR] tested within 72 hours of randomization) <br/ ><br> <br/ ><br>Additional details: <br/ ><br>· Serum creatinine value needs to be obtained for all patients before enrolment. Those patients with a calculated eGFR < 15mLl/min/1.73m2 should be excluded. A normal creatinine value estimated within the previous 90 days will be acceptable as a baseline value. However, in such cases, the creatinine should be repeated within three days of randomization. <br/ ><br> <br/ ><br>·Baseline liver function test to be done to rule out liver disease. <br/ ><br> <br/ ><br>·Urine pregnancy test (in women in reproductive age group) to be done to rule out pregnancy.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: Interferon-Ã?: 0.25 mg subcutaneous injection on days 1, 3, 5, and 7 starting on day 1<br>Intervention2: Colchicine: eGFR â?¥30 mL/min/1.73m2: 0.5 mg twice daily for 3 days, then 0.5 mg once daily for upto25 days (total 28 days).eGFR 15 to 29 mL/min/1.73m2: 0.5 mg once daily for upto28 days.<br><br>(Depending on availability, 0.6 mg tablets can be substituted by 0.5 mg tablets. The duration of treatment is minimum of 14 days and a maximum of 28 days. If a patient has recovered by Day 14 then at the discretion of the investigator the colchicine treatment can be discontinued.)<br>Intervention3: Acetylsalicylic acid: 75 mg once daily for 28 days.<br>Intervention4: Rivaroxaban: 2.5 mg twice daily for 28 days<br>Control Intervention1: control: Usual care other than avoidance of potentially interacting non-study treatments.<br>→ | Primary: hospitalization or death; co-primary: disease progression by 2 points on a 7-point scale; co-primary (ASA vs. control only): a composite of major adverse cardiovascular events (MI, stroke, ALI, VTE, death)Timepoint: 45 DAYS→ | | | | Yes | False | | |
| → | CTRI/2021/08/035910 | 7 September 2021 | This study is to evaluate benefit of adding 2-deoxy-D-glucose (2-DG) over
standard treatments in mild COVID-19 patients.
| A multicenter, randomized, double blind, placebo controlled, parallel group study to evaluate the safety and efficacy of oral 2-deoxy-D-glucose (2-DG) as adjunctive treatment to standard of care in the treatment of mild COVID-19 patients managed in quarantine under self-assessment. | | Dr Reddys Laboratories Limited | 25-08-2021 | 20210825 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58968 | Not Recruiting | No | | | | 01-09-2021 | 800 | Interventional | Other<br> Method of generating randomization sequence:Stratified randomization Method of allocation concealment:Centralized Blinding and masking:Double Blind Double Dummy | Phase 3 | India→ | Dr D Mallikarjuna Rao→ | | IPDO, Sy, No, 54, Innovation Plaza, Bachupally, Hyderabad â?? 500090 → | srinivasshenoyb@drreddys.com→ | 9833974488→ | Dr. Reddyâ??s Laboratories Limited→ | Inclusion criteria: 1. Patients willing and able to provide voluntary written informed consent (assent in case of patients aged 12- <18 years old, with written consent obtained for their parent/legal guardian) and comply protocol requirements. <br/ ><br>2. Male or female patients aged 12 years of age or older <br/ ><br>3. Patients with positive RT-PCR test for SARS-CoV-2 on nasopharyngeal or oropharyngeal swab sample (with sample being collected â?¤5 days prior to day of randomization) <br/ ><br>4. Patients with â??mildâ?? COVID-19 disease severity, as defined by Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI; , AND having any of the following symptoms and signs prior to randomization: <br/ ><br>Fever, cough, sore throat/throat irritation, body ache/headache, malaise/weakness, diarrhoea or gastrointestinal upset, with or without anorexia/nausea/vomiting, with or without loss of smell and/or taste, no shortness of breath/breathlessness <br/ ><br>Respiratory rate of less than 24/min, SpO2 â?¥ 94% on room air. <br/ ><br>5. Patients (12 to <18 years) with â??mildâ?? COVID-19 disease severity, as defined by Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI, AND having any of the following symptoms and signs prior to randomization: <br/ ><br>Children presenting with fever, sore throat, diarrhoea, anorexia/nausea/vomiting, loss of sense of smell and/or taste, malaise/weakness, body ache/headache, rhinorrhea, cough with no breathing difficulty (grunting, severe retractions of chest), somnolence, lethargy and seizures <br/ ><br>Respiratory rate <30 /min, SpO2 â?¥ 94% on room air <br/ ><br>6. Patients with SpO2 â?¥ 94% on two consecutive pulse-oximetric measurements performed at least two hours apart, on room air, when assessed prior to randomization. <br/ ><br>7. Is willing and able to take oral medication <br/ ><br>8. In case of female patients of child-bearing potential, a negative urine pregnancy test prior to beginning the therapy. <br/ ><br>9. Patient agrees to completely abstain from sexual activity or to take effective contraception measures (including hormonal contraception or double barrier method) with his/her partner during the study period. <br/ ><br>As per latest Guidance documents updated periodically by Directorate General of Health Services, MoHFW, GOI <br/ ><br>→ | Exclusion criteria: 1. Patients with â??moderateâ?? or â??severeâ?? COVID-19 disease severity, as defined by latest Comprehensive Guidelines for Management of COVID-19 patients, Directorate General of Health Services, MoHFW, GOI and Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI at the time of randomization. This includes any one or more of the following: <br/ ><br>A) Peripheral Blood oxygen saturation < 94% <br/ ><br>B) Respiratory Rate â?¥ 24 breaths per minute for adults and â?¥ 30 breaths per minute for patients aged 12 to <18 years. <br/ ><br>C) Presence of shortness of breath (dyspnea) at rest, as a symptom <br/ ><br>D) Grunting, severe retraction of chest, lethargy, somnolence and Seizure in patients aged 12 to <18 years <br/ ><br>2. Patients with first onset of symptom(s) known to be associated with COVID-19 was >5 days prior to the day of randomization <br/ ><br>3. Patients who are currently hospitalized/ need hospitalization OR are expected to deteriorate to need hospitalization for COVID-19 management within 48 hours after randomization, in the opinion of the Investigator <br/ ><br>4. Patients with previous history of hypersensitivity or contra-indication to the IMP 2-deoxy-D-glucose or to the imaging marker fluorodeoxyglucose (FDG). <br/ ><br>5. Patients with : <br/ ><br>A) Presence of Uncontrolled diabetes mellitus <br/ ><br>B) Presence or History of any Cardiac conduction disorders OR QTc interval >500 ms at baseline assessment <br/ ><br>C) Presence of gastrointestinal disorder that could affect absorption of orally administered 2-DG solution <br/ ><br>D) Presence or history of any other disease or condition which, in the opinion of the Investigator, could prevent, limit or confound protocol-specified assessments or could jeopardize the safety of patient if (s)he were to participate in the study <br/ ><br>6. Pregnant and Lactating patients. <br/ ><br>7. Patients not expected to survive longer than 48 hours (due to any reason) at the time of randomization, in the opinion of the Investigator <br/ ><br>8. Patients who are receiving drugs that are known to prolong QT interval of the heart (including hydroxychloroquine) or are expected to require treatment with the same during the study period <br/ ><br>9. Patients that are currently or have participated in such studies participating in other clinical studies with investigational drug, biological agent or device within 1 month or within 5 half-lives (of the drug/biologic) prior to randomization (whichever is longer). <br/ ><br>10. Patients with body weight <35 or > 105 kg. <br/ ><br>Categorization of COVID-19 disease severity as â??mildâ??, â??moderateâ??, â??severeâ?? is as per the â??Comprehensive Guidelines for Management of COVID-19 patientsâ?? (In Adults) Directorate General of Health Services, MoHFW, GOI and <br/ ><br>COVID-19 disease severity, as defined by â??Guidelines for Management of COVID-19 in Children (below 18 years)â??, MoHFW, GOI <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: 2-Deoxy-D-Glucose (2-DG) powder for oral Solution: 2-deoxy-D-glucose (2-DG) powder for oral solution will be made available for the current study as sachets containing 2.34 g and will be administered as an oral solution at a dose of [approximately] 45 mg/kg of body weight approximately 12 hours apart, in a day)<br>Control Intervention1: Placebo for 2-DG: Placebo for 2-deoxy-D-glucose (2-DG) powder for oral solution will be made available for the current study as sachets containing 2.34 g and will be administered as an oral solution at a dose of [approximately] 45 mg/kg of body weight approximately 12 hours apart, in a day)<br>→ | Efficacy of oral 2-DG in comparison to placebo in preventing worsening of COVID-19 clinical disease severity, in RT-PCR confirmed SARS-CoV-2 patients having mild COVID-19 disease, when administered as adjunctive treatment to standard of care managementTimepoint: Randomization to Day 14→ | | | | Yes | False | | |
| +++ | CTRI/2021/08/035920 | 7 September 2021 | Study on the Safety and Efficacy of Niclosamide in Patients with COVID-19 with Gastrointestinal Infection | Reservoir: A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study on the Safety and Efficacy of Niclosamide in Patients with COVID-19 with Gastrointestinal Infection. - NA | | AzurRx BioPharma Inc | 25-08-2021 | 20210825 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58827 | Not Recruiting | No | | | | 08-09-2021 | 148 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 2 | | | | | | | | | | | | | | | | Yes | False | | |
| → | CTRI/2021/08/035921 | 7 September 2021 | Outcomes in surgery following Covid infection | Incidence and severity of post-operative complications in patients post COVID 19 infection | | Amrita Institute of Medical Sciences | 25-08-2021 | 20210825 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59653 | Not Recruiting | No | | | | 10-09-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | DrAnnu Susan Abraham→ | | Department of Anaesthesiology and Critical Care
Amrita Institute of Medical Sciences
Kochi → | annuabraham7@gmail.com→ | 9400114643→ | Amrita Institute of Medical Sciences→ | Inclusion criteria: Patients with previous COVID infections presenting for surgery→ | Exclusion criteria: Patients with active COVID infection→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Pulmonary complications in the post operative periodTimepoint: Pulmonary complications in the first 10 days after surgery→ | | | | Yes | False | | |
| → | CTRI/2021/08/035928 | 7 September 2021 | A Study to Assess the Impact of Associated ACE Gene Polymorphism in The Severity of Covid-19. | A Prospective, Quasi Randomize, Cross-sectional Study to Assess the Impact of Associated ACE Gene Polymorphism in The Severity of Covid-19. | | Adichunchanagiri University | 25-08-2021 | 20210825 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59496 | Recruiting | No | | | | 30-08-2021 | 1000 | Observational | Other<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Rajesh Venkataraman→ | | Clinical trial Center
2nd floor
Room no 001
AH and RC BG Nagara
Mandya→ | sanjay.mysore82@gmail.com→ | | Adichunchanagiri Institute of Medical sciences→ | Inclusion criteria: Patients diagnosed with Covid-19 by any diagnostic tool (i.e., RT-PCR, CT scan or X-Ray and any other as per the clinical decision taken by the treating physician). <br/ ><br>Patients who have been admitted or in self-quarantined. <br/ ><br>All the patients who will give a consent. <br/ ><br>→ | Exclusion criteria: Patient with Chronic Kidney disease, undergoing dialysis and whose creatinine clearance is â?¤30Ml/min. <br/ ><br>Evidence of cirrhosis, Hepatitis B virus or Hepatitis C virus infection. <br/ ><br>Patients who are unable to give a consent. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B342- Coronavirus infection, unspecified
→ | Intervention1: Not applicable: Not applicable<br>→ | The study will help to find out the relation between the ACE gene polymorphism and the severity of the Covid-19. <br/ ><br> <br/ ><br>This study can measure the ACE II, ID and II genotype frequencies in Indian population. <br/ ><br>Timepoint: 3 years <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/08/035946 | 7 September 2021 | Body functions and activities of daily living in individuals after COVID 19 recovery. | Screening for fatigue and musculoskeletal dysfunction in post COVID-19 survivors. - NA | | NA | 26-08-2021 | 20210826 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57331 | Not Recruiting | No | | | | 01-09-2021 | 343 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Hemali Mehta→ | | Department of Physiotherapy, Manipal College of Health Professionals,
Manipal Academy of Higher Education,
Manipal. Department of Physiotherapy, Manipal College of Health Professionals,
Manipal Academy of Higher Education,
Manipal.→ | nivedita.kamath@manipal.edu→ | 9901729546→ | Manipal University→ | Inclusion criteria: -Individuals recovered from COVID-19 infection with a confirmed negative diagnostic test result. <br/ ><br>-Individuals infected with COVID-19 within 6 months.→ | Exclusion criteria: -Inability of the individual to comprehend the questionnaire due to cognitive deficit.→ | | | This study will help us know about the severity of fatigue and musculoskeletal dysfunction of COVID-19 survivors.Timepoint: Post COVID recovery (post 17days after infection)→ | | | | Yes | False | | |
| → | CTRI/2021/08/035951 | 7 September 2021 | Comparative analysis of 1st and 2nd wave of COVID-19 | Comparison of demographic, clinical and microbiological profile for cases infected in Ist Vs IInd wave of SARS-CoV-2 | | Kasturba Medical College Manipal | 26-08-2021 | 20210826 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59668 | Not Recruiting | No | | | | 30-08-2021 | 7187 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Kiran Chawla→ | | Department of Microbiology, KMC Manipal → | kiran.chawla@manipal.edu→ | 9980220484→ | KMC Manipal. MAHE→ | Inclusion criteria: Samples detected positive with RTPCR/GeneXpert testing for SARS-CoV-2 from 13/05/2020 to 31/05/2021→ | Exclusion criteria: Inconclusive samples or negative microbiologically→ | Health Condition 1: J028- Acute pharyngitis due to other specified organisms
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Detailed comparison of infected cases in two waves of COVID will be achievedTimepoint: 6 months→ | | | | Yes | False | | |
| → | CTRI/2021/08/035953 | 7 September 2021 | Extent and trends of internet addiction in health care professionals during COVID 19 | Prevalence and pattern of internet addiction in health care professionals during COVID 19 - IAT HCP | | Government Medical college | 26-08-2021 | 20210826 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57796 | Not Recruiting | No | | | | 01-09-2021 | 400 | Observational | Other<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Dr Ajeet Sidana→ | | D Block level 5, psychiatry office, Government Medical college and Hospital, Chandigarh GMCH Chandigarh→ | ajeetsidana@hotmail.com→ | 9646121614→ | GMCH Chandigarh→ | Inclusion criteria: Using Internet for at least 1 year→ | Exclusion criteria: Not willing to participate <br/ ><br>Incomplete google forms→ | | | Prevelance and Pattern of Internet Addiction in Health care professionalsTimepoint: Internet Addiction before Lockdown, during Lockdown and after Lockdown→ | | | | Yes | False | | |
| → | CTRI/2021/08/035955 | 7 September 2021 | Management of COVID-19 symptoms with Yoga and Standard treatment . | YOGA-REHAB trial for management of long COVID symptoms - YOGA REHAB | | Dr Naveet Wig | 26-08-2021 | 20210826 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58121 | Not Recruiting | No | | | | 12-09-2021 | 160 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | N/A | India→ | Dr Manish Soneja→ | | Department of Medicine ,All India Institute of Medical Sciences New Delhi → | manishsoneja@gmail.com→ | 01126594415→ | All Insitute of medical Sciences→ | Inclusion criteria: 1.Both sexes aged 18 to 65 years <br/ ><br>2.Confirmed diagnosed cases of COVID 19, who have completed 4 weeks since the onset of the symptoms and presenting with at least one or more than one symptom of Long COVID (fatigue, myalgia, dyspnoea, cough, palpitations, headache, attention, sleep disturbances, anxiety, depression) <br/ ><br>3.Willing and able to perform any form of exercise <br/ ><br>4.Willing to comply with the study requirements and scheduled visits <br/ ><br>→ | Exclusion criteria: 1.Known cases of CAD (coronary artery disease) with moderate to severe LV (Left ventricular) dysfunction, history of CVA (Cerebrovascular Accident) or any neurodegenerative diseases. <br/ ><br>2.Pregnant and lactating women. <br/ ><br>3.Participating in any other trial and receiving any other investigational product <br/ ><br>4.Patients practicing any form of regular and structured yoga practice. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B998- Other infectious disease
→ | Intervention1: Yoga: Yoga based rehabilitation on long COVID symptoms (A reduction is 0-27 symptoms score with each symptoms evaluated on 0-30 scale.<br>Duration: 30 min <br>no of session : 3 sessions /12 week<br>Control Intervention1: Standard of Care: standard care as per Department of Medicine AIIMS New Delhi<br>→ | Reduction in symptoms of Long COVID-19Timepoint: 12 week→ | | | | Yes | False | | |
| → | CTRI/2021/08/035961 | 7 September 2021 | CLINICAL OUTCOME AND ITS CORRELATION WITH INFLAMMATORY MARKERS IN SARS COVID-19 | CLINICAL OUTCOME AND ITS CORRELATION WITH INFLAMMATORY MARKERS IN SARS COVID-19 PATIENTS. | | maddali aravind surya | 26-08-2021 | 20210826 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59579 | Not Recruiting | No | | | | 30-08-2021 | 62 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | maddali aravind surya→ | | E4,DEPARTMENT OF GENERAL MEDICINE → | lokeshsdr@gmail.com→ | 8825481583→ | Mahathma gandhi medical colleage and research institute→ | Inclusion criteria: PATIENTS OF BOTH SEXES <br/ ><br>AGE >18 <br/ ><br>PATIENTS TESTED POSITIVE FOR COVID-19 BY RTPCR→ | Exclusion criteria: OTHER SYSTEMIC INFECTIONS <br/ ><br>INFLAMMATORY AND AUTO IMMUNE DISORDERS <br/ ><br>PATIENTS ON LONG TERM STEROID AND OTHER CYTOTOXIC DRUGS→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | DEATH DUE TO COVIDTimepoint: 1 year 6 months <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/08/035993 | 7 September 2021 | Heterologus Prime-Boost Combination of SARS-CoV-2 Vaccines | A Phase 2 randomized, multi-centric, Clinical Trial of Heterologus Prime-Boost Combination of SARSCoV-
2 Vaccines to evaluate the immunogenicity and safety of BBV152 (COVAXIN®) with BBV154(Adenoviral Intranasal COVID-19 vaccine) in Healthy Volunteers. - BBV152/BBV154 | | Bharat Biotech International Limited | 27-08-2021 | 20210827 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59216 | Recruiting | No | | | | 28-08-2021 | 608 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Other Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India→ | Dr V Krishna Mohan→ | | Medical Affairs Department
S Block
Genome valley
Shameerpet
Hyderabad → | kmohan@bharatbiotech.com→ | 914023480567→ | Bharat Biotech International Limited→ | Inclusion criteria: 1.Ability to provide written informed consent. <br/ ><br>2.Participants of either gender, ages between â?¥18 years - <65 Years. <br/ ><br>3.Good general health as determined by the discretion of investigator (vital signs (heart rate â?¥60 to â?¤100 bpm; blood pressure systolic â?¥90 mm Hg and <140 mm Hg; diastolic â?¥ 60 mm Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical examination). <br/ ><br>4.Expressed interest and availability to fulfil the study requirements. <br/ ><br>5.For a female participant of child-bearing potential, planning to avoid becoming pregnant (use of an effective method of contraception or abstinence) from the time of study enrolment until at least four weeks after the last vaccination <br/ ><br>6.Male subjects of reproductive potential: Use of condoms to ensure effective contraception with the female partner from first vaccination until 3 months after last vaccination <br/ ><br>7.Participants must refrain from blood/plasma or any other bodily fluid donation from the time of first vaccination until 3 months after the last vaccination <br/ ><br>8.Agrees not to participate in another clinical trial at any time during the study period. <br/ ><br>9.Agrees to remain in the study area for the entire duration of the study. <br/ ><br>10.Willing to allow storage and future use of biological samples for future research <br/ ><br>→ | Exclusion criteria: 1.History of any other COVID-19 investigational/or licensed vaccination. <br/ ><br>2.History of cold, sneezing, nasal obstruction in the past 1 day. <br/ ><br>3.For women of childbearing potential, a positive urine pregnancy test (within 24 hours of administering each dose of vaccine). <br/ ><br>4.Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an upper respiratory infection or gastroenteritis within three days before each dose of vaccine. <br/ ><br>5.Medical problems because of alcohol or illicit drug use during the past 12 months. <br/ ><br>6.Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before enrolment or expects to receive an investigational agent during the study period. <br/ ><br>7.Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ ><br>8.Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction and history of allergies in the past. <br/ ><br>9.Receipt of immunoglobulin or other blood products within the three months before vaccination in this study. <br/ ><br>10.Immunosuppression as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. <br/ ><br>11.Long-term use ( > 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding six months (nasal and topical steroids are allowed). <br/ ><br>12.Any history of anaphylaxis concerning vaccination. <br/ ><br>13.History of any cancer. <br/ ><br>14.History of severe psychiatric severe conditions likely to affect participation in the study. <br/ ><br>15.A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior history of significant bleeding or bruising following IM injections or venipuncture. <br/ ><br>16.Any other serious chronic illness requiring immediate hospital specialist supervision. <br/ ><br>17.Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a volunteer participating in the trial or would render the subject unable to comply with the protocol. <br/ ><br>Re-Vaccination Exclusion Criteria <br/ ><br>18.Pregnancy. <br/ ><br>19.Anaphylactic reaction following administration of the vaccine. <br/ ><br>20.Virologically confirmed cases of SARS-CoV-2 infection. <br/ ><br>→ | | Intervention1: BBV152: 0.5 mL Vero cell derived inactivated vaccine containing NLT 6μg and<br>administered as a single dose intramuscularly (IM)<br>Intervention2: BBV154: BBV154 is a liquid, Adenoviral vector-based (expressing a stabilized spike protein) SARS-CoV-2 vaccine (BBV154) administered as intranasal route (nasal drop)<br>Control Intervention1: NA: NA<br>→ | ï?? GMT and four-fold seroconversion rate (SCR) of neutralizing antibodies (NAbâ??s) by MNT/PRNT assays across the four groups, from baseline to days 28+2, 56±7, 90±7 and 180 ±7Timepoint: day 28,56,90 and 108→ | | | | Yes | False | | |
| → | CTRI/2021/08/036010 | 7 September 2021 | Clinical trial of GP/AYU/2021/001 Kit in patients with Covid 19. | A Double blind, randomized, placebo controlled clinical trial to evaluate safety and efficacy of GP/AYU/2021/001 Kit in patients with SARS-CoV-2 Infection. - NA | | Mr Kamlesh Thummar | 27-08-2021 | 20210827 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59795 | Not Recruiting | No | | | | 05-09-2021 | 300 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Participant and Investigator Blinded | Phase 3 | India→ | Mr Chetan savaliya→ | | 708, seventh floor,Cabin no. 1, Infinity tower Near Ayurvedic hospital near railway station Surat → | gplifehealthcare@gmail.com→ | | Gplife Healthcare Pvt Ltd→ | Inclusion criteria: Patients admitted with RT-PCR confirmed COVID-19 illness <br/ ><br>Mild to Moderately Covid 19 disease (NEWS score less than or equal to 8) <br/ ><br>Signed informed consent must be obtained and documented according to national/local regulations→ | Exclusion criteria: Pregnant women. <br/ ><br>Breastfeeding women. <br/ ><br>Requiring ICU admission at screening <br/ ><br>Patients above 65 years of age and below 18 Years <br/ ><br>Past History of MI, Epileptic episodes <br/ ><br>Any other co-morbidity (uncontrolled diabetes, severe hypertension from subject history) which <br/ ><br>is at the critical stage at a screening <br/ ><br>Any other condition by which subject proves unfit from the investigator perspective <br/ ><br>Not giving consent.→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: COROPROTECT TABLET and COROPROTECT DRY SYRUP: 2 tablets twice a day and 10 ml syrup thrice a day along with standard of care for 10 days<br>Control Intervention1: Standard of care: Standard of care as per ICMR protocol for 10 days<br>→ | No. of days for negative RTPCR confirmatory test from nasopharyngeal swab for SARS-Covid 2. <br/ ><br>Change in clinical symptom presentation in cough, breathlessness, fatigue, persistent pain and pressure in the chest on 5-point ordinal scale: None (1), mild (2), moderate (3), severe (4), extremely severe (5) <br/ ><br>Serum CRP, LDH, Ferritin, Interleukin 6. <br/ ><br>Immunity Panel levels (CD3, CD4, CD8)Timepoint: From baseline to day 10→ | | | | Yes | False | | |
| → | CTRI/2021/08/036011 | 7 September 2021 | Evaluation of Quadriceps muscle strength in patients post Covid -19 | Evaluation of Quadriceps muscle strength in patients post Covid -19 | | Ramaiah Medical college | 27-08-2021 | 20210827 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58904 | Not Recruiting | No | | | | 04-09-2021 | 36 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Tejuvarshini V→ | | Ramaiah Medical College
(Department of Physiotherapy)
MSR College Rd, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054 Ramaiah Medical College Hospital
MSR College Rd, M S Ramaiah Nagar, Mathikere, Bengaluru, Karnataka 560054→ | veenakiran_nambiar@yahoo.co.in→ | 9880575407→ | Ramaiah Medical College (Department of Physiotherapy)→ | Inclusion criteria: Patients recovered from COVID -19 illness <br/ ><br>1 Age- 20-50yrs <br/ ><br>2 Patients whose RT-PCR test results were positive <br/ ><br>3 Post COVID-19 illness - Between 6-12weeks <br/ ><br>4 Condition of the patient - Self-ambulatory (without assistive devices) <br/ ><br> <br/ ><br>Healthy individuals <br/ ><br>1 Age- 20-50yrs→ | Exclusion criteria: Patients recovered from COVID-19 illness <br/ ><br>1 Neurologic diseases such as stroke, polyneuropathy, Muscular dystrophy, <br/ ><br>Myasthenia gravis, Myositis <br/ ><br>2 Orthopaedic conditions such as Total knee replacement, Rheumatoid arthritis, <br/ ><br>Hip and Knee osteoarthritis, osteoporosis and recent fractures(3months) of <br/ ><br>lower extremity <br/ ><br>3 Oncology conditions <br/ ><br>4 Cardio-pulmonary conditions such as COPD, congestive heart failure, <br/ ><br>peripheral artery disease and cardiac arrest <br/ ><br>Renal conditions such as chronic kidney disease, glomerulonephritis, acute <br/ ><br>and chronic renal failure <br/ ><br>5 Patients who were on steroids as a part of their treatment. <br/ ><br> <br/ ><br>Healthy individuals <br/ ><br>1 Abuse of alcohol and drugs <br/ ><br>2 Involved in rehabilitation or structured exercise programme during previous <br/ ><br>3months <br/ ><br>3 Neurologic diseases such as stroke, polyneuropathy, Muscular dystrophy, <br/ ><br>Myasthenia gravis, Myositis <br/ ><br>4 Orthopaedic conditions such as Total knee replacement, Rheumatoid arthritis, <br/ ><br>Hip and Knee osteoarthritis, osteoporosis and recent fractures(3months) of <br/ ><br>lower extremity <br/ ><br>5 Oncology conditions <br/ ><br>6 Cardio-pulmonary conditions such as COPD, congestive heart failure, <br/ ><br>peripheral artery disease and cardiac arrest <br/ ><br>7 Renal conditions such as chronic kidney disease, glomerulonephritis, acute <br/ ><br>and chronic renal failure→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J22- Unspecified acute lower respiratory infection
→ | | Peak torque (nm)Timepoint: 6weeks to 12 weeeks→ | | | | Yes | False | | |
| → | CTRI/2021/08/036013 | 7 September 2021 | A study determine effectiveness and safety of COVID-19 vaccination in health care workers in India | A cross sectional real world evidence (RWE) study of effectiveness and safety of COVID-19 vaccination in health care workers in India | | Indian Society of Clinical Research | 27-08-2021 | 20210827 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58870 | Not Recruiting | No | | | | 31-08-2021 | 2000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Ms Jayanthi Swaminathan→ | | Flat 1/16 and 1/17, Second floor, Krishnadeep Chambers, (Apollo Annexe), #1, Wallace Gardens, Chennai → | jayanthi.s@apolloari.com→ | | Apollo Research and Innovations→ | Inclusion criteria: health care workers who have received at least 1 dose of Covishiled or Covaxin between 16 Dec 2020 and 30 Apr 2021→ | Exclusion criteria: health care workers who did not take any COVID-19 vaccine→ | | | 1) Post vaccination infection with COVID-19 (as confirmed by RT PCR and antigen test results) and duration between the last dose and infection and how many doses of vaccines were taken <br/ ><br>2) Number and percentage of Adverse events following Immunization (AEFI) will be presented such as: pain at injection site, body ache, fever, hospitalization and reason for hospitalization etcTimepoint: At the time of study data collection→ | | | | Yes | False | | |
| → | CTRI/2021/08/036025 | 7 September 2021 | A randomized clinical trial to determine efficacy of Ayurveda medicine in the treatment COVID 19 patients | To determine the therapeutic efficacy of NF2 and NF4 in the treatment of COVID-19 | | Sri Sri Institute for advanced research Begaluru Karnataka | 31-08-2021 | 20210831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59037 | Not Recruiting | No | | | | 01-09-2021 | 100 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Alternation Blinding and masking:Participant and Investigator Blinded | Phase 2 | India→ | Dr Sanjib kumar Das→ | | Deptt of Kayachikitsa Ayurveda Division Room No C03 Sri Sri College of Ayurvedic Science and Research Hospital Sri Sri University Cuttack Odisha 754006 Deptt of Kayachikitsa Ayurveda Division Room No C03 Sri Sri College of Ayurvedic Science and Research→ | sanjib.d@srisriuniversity.edu.in→ | 9437292457→ | Sri Sri College of Ayurvedic Science and Research Hospital→ | Inclusion criteria: FEVER >98.6 DEGREE F <br/ ><br>SYMPTOMATIC COVID 19 INFECTION WITHOUT CO MORBIDITY <br/ ><br>WILLINGNESS TO PARTICIPATE IN THE STUDY <br/ ><br>SpO2 >93% <br/ ><br>nationality Indian <br/ ><br>→ | Exclusion criteria: AGE <15 AND >70 <br/ ><br>T2DM <br/ ><br>CKD <br/ ><br>BA <br/ ><br>CVA <br/ ><br>CVS DISORDER <br/ ><br>COPD <br/ ><br>PREGNANCY AND LACTATION <br/ ><br>MALIGNANCY→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | Primary <br/ ><br>TO CONTROL THE SIGN AND SYMPTOM OF COVID19 <br/ ><br>RTPCR NEGATIVE <br/ ><br>Timepoint: day 1 <br/ ><br>day 5 <br/ ><br>day 10 <br/ ><br>→ | | | | Yes | False | | |
| → | CTRI/2021/08/036045 | 7 September 2021 | To evaluate the safety, tolerability and efficacy of ZRC COVIMABS in the treatment of mild COVID-19 disease. | A randomized, open-label, adaptive, phase 1/phase 2 study to evaluate the safety, tolerability and efficacy of ZRC COVIMABS in the treatment of mild COVID-19 disease. | | Cadila Healthcare Ltd | 31-08-2021 | 20210831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58714 | Not Recruiting | No | | | | 01-09-2021 | 332 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 1/ Phase 2 | India→ | Dr Taufik Momin→ | | Zydus Research Centre, Survey No. 396/403, Opp. Sarvotam Hotel, Nr. Nova Petrochemicals, Sarkhej-Bavla N.H. No. 8A, Village: Moraiya, → | Taufik.Momin@zyduscadila.com→ | 2717665555→ | Cadila Healthcare Limited→ | Inclusion criteria: 1.Adult male or female subjectâ??s â?¥ 18 years. <br/ ><br>2.Positive for COVID-19 by an approved test (RT PCR). <br/ ><br>3.Subjects with COVID-19 with mild disease and who are at high risk for progressing to severe COVID-19 and/or hospitalization. <br/ ><br>Mild disease defined as upper respiratory tract symptoms &/or fever WITHOUT shortness of breath or hypoxia. (Reference: Clinical guidance for management of adult Covid-19 subjects, Ministry of Health & Family welfare, Government of India, 24 May 2021). <br/ ><br>High risk is defined as: Subjects who meet at least one of the following criteria: <br/ ><br>â?¢Age > 60years OR <br/ ><br>â?¢Cardiovascular disease, hypertension, OR CAD OR <br/ ><br>â?¢DM (Diabetes mellitus) OR other immunocompromised states OR <br/ ><br>â?¢Chronic lung/kidney/liver disease OR <br/ ><br>â?¢Cerebrovascular disease OR <br/ ><br>â?¢Obesity (BMI â?¥ 30 kg/m2) <br/ ><br>4.Able and willing to complete informed consent process with understanding of the purpose and procedures of the study. <br/ ><br>5.Willing and able to comply with all planned study procedures and be available for all study visits and follow-up as required by the protocol. <br/ ><br>6.Male subjects and female subjects of childbearing potential must practice highly effective contraception during the study and be willing and able to continue contraception for 90 days after administration of study dose. <br/ ><br>→ | Exclusion criteria: 1.Evidence of moderate or severe COVID-19 disease as per the Clinical guidance for management of adult Covid-19 subjects, Ministry of Health & Family welfare, Government of India, 17 May 2021. <br/ ><br>(Moderate disease: Any one of (1) Respiratory rate â?¥ 24/min, breathlessness; (2) SpO2 90% to â?¤ 93% on room air) <br/ ><br>(Severe disease: Any one of (1) Respiratory rate >30/min, breathlessness; (2) SpO2 < 90% on room air) <br/ ><br>2.Onset of COVID-19 symptoms before 5 days from planned study drug administration. <br/ ><br>3.Current hospitalization due to COVID at the time of screening. <br/ ><br>4.Has a documented infection other than COVID-19. <br/ ><br>5.Has received a COVID-19 vaccine (For Phase 2: However, vaccinated subjects who are infected can be enrolled based on a case by case basis). <br/ ><br>6.Has participated, or is participating, in a clinical research study evaluating COVID-19 convalescent plasma, monoclonal antibodies (mAbs) against SARS-CoV-2, or intravenous immunoglobulin (IVIG) within 3 months or less than 5 half-lives of the investigational product (whichever is longer) prior to the screening visit. <br/ ><br>7.Has a history of hypersensitivity reactions to therapeutic proteins. <br/ ><br>8.Pregnant or lactating and breast feeding or planning on either during the study. <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | Intervention1: COVIMABS & SOC: 1) Details :- A total of 32 subjects in phase 1 study in the four cohorts (6 ZRC COVIMABS plus SOC + 2 SOC in each cohort) <br>2)Dose :-300mg,600mg,1200mg,2400mg<br>3)Route:-Intravenous<br>4)Phase II:-The treatment arms, cohorts, sample size, and treatment allocation scheme for phase 2 will be finalized after review of phase I data.<br>Control Intervention1: NA: NA<br>→ | To evaluate the safety and tolerability of ZRC COVIMABS plus SOC compared to SOC alone up to 14 daysTimepoint: baseline to 14 days→ | | | | Yes | False | | |
| → | CTRI/2021/08/036074 | 7 September 2021 | Biological Eâ??s CORBEVAX vaccine clinical study for protection against Covid-19 disease. | A Prospective, Single-blind, Randomized, Active-controlled Phase III Clinical Study to Evaluate the Immunogenicity and Safety of Biological Eâ??s CORBEVAX Vaccine for Protection Against COVID-19 Disease When Administered to RT-PCR Negative Adult Subjects. - None | | Biological E Limited | 31-08-2021 | 20210831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59772 | Not Recruiting | No | | | | 03-09-2021 | 2140 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant Blinded | Phase 3 | India→ | Subba Reddy GV→ | | Clinical Development Dept, 2nd floor, Road No.35, Jubilee Hills → | kishore.turaga@biologicale.com→ | 04071216247→ | Biological E.Limited→ | Inclusion criteria: 1. Subject is seronegative to anti-SARS-CoV-2 IgG antibody prior to randomisation either into Group-1 and Group-2. <br/ ><br>2. Subject is virologically seronegative to SARS-CoV-2 infection as confirmed by RT-PCR prior to enrolment in all groups. <br/ ><br>3. Male or female subject between â?¥ 18 to 80 years of age. <br/ ><br>4. Subject is willing to provide a written informed consent for voluntary participation in the study. <br/ ><br>5. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol. <br/ ><br>6. Subject is seronegative to HIV 1 & 2, HBV and HCV infection prior to enrolment. <br/ ><br>7. Subject is considered of stable health as judged by the investigator, determined by medical history and physical examination. <br/ ><br>8. Female subject of child bearing potential must have a negative urine pregnancy test (UPT), and willingness to avoid becoming pregnant through use of an effective method of contraception or abstinence from the time of study enrolment until six weeks after the last dose of vaccination in the study. <br/ ><br>9. Male subject, who is sexually active, must agree to use double-barrier contraception (e.g. condom with spermicide) with his female partner during the study period. Male subject should also agree to avoid semen donation or providing semen for in-vitro fertilization during the study duration. <br/ ><br>10. Subject agrees not to participate in another clinical trial at any time during the total study period. <br/ ><br>11. Subject agrees to refrain from blood donation during the course of the study. <br/ ><br>12. Subject agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ ><br>→ | Exclusion criteria: 1. History of vaccination with any investigational or approved vaccine against COVID-19 disease. <br/ ><br>2. Subject living in the same household as that of any active COVID-19 positive individual. <br/ ><br>3. History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines); <br/ ><br>4. Subjects with any clinically significant abnormal haematology and biochemical laboratory parameters tested at screening as judged by the investigator. <br/ ><br>5. Subjects with Body temperature of â?¥100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination. <br/ ><br>6. Pregnant women, nursing women or women of childbearing potential who are not actively avoiding pregnancy during the study. <br/ ><br>7. Subjects with known current or chronic history of any of the following conditions, likely to affect participation in the study: <br/ ><br>8. severe psychiatric conditions; <br/ ><br>9. any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder); <br/ ><br>10. allergic disease or reactions likely to be exacerbated by any component of the study vaccine (BE SARS-CoV-2 COVID-19 vaccine); <br/ ><br>11. neurological illness, and any other serious chronic illness requiring hospital specialist supervision. <br/ ><br>12. Subjects requiring chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. <br/ ><br>13. For corticosteroids, this will mean prednisone â?¥0.5 mg/kg/day, or equivalent. <br/ ><br>14. Inhaled and topical steroids are allowed. <br/ ><br>15. Receipt of prohibited concomitant medication that may jeopardize the safety of the participant or interpretation of the data. <br/ ><br>16. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). <br/ ><br>17. Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ ><br>18. Planned use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment. <br/ ><br>19. Current or planned participation in prophylactic drug trials for the duration of the study. <br/ ><br>20. Individuals who are part of the study team or close family members of individuals conducting the study. <br/ ><br>→ | | Intervention1: Biological Eâ??s CORBEVAX Vaccine: Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses at Day 0 and Day 28.<br>Control Intervention1: Serum Institute of India Pvt. Ltdâ??s- COVISHIELD: Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses at Day 0 and Day 28.<br>→ | 1.Immune response measured after completion of 2-dose immunization schedule, as determined by geometric mean titres (GMT/C) of SARS-CoV-2 specific neutralising antibodies to evaluate immunogenic superiorityTimepoint: 1. After 14 days→ | | | | Yes | False | | |
| → | CTRI/2021/08/036079 | 7 September 2021 | Functional health status of children with CP during COVID-19 pandemic | Parent-reported change in functional health status of children with cerebral palsy during COVID-19 pandemic:A cross-sectional study - FHS | | Nikhat Naaz | 31-08-2021 | 20210831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59983 | Not Recruiting | No | | | | 10-09-2021 | 96 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India→ | Nikhat Naaz→ | | Department of Physiotherapy,
MS Ramaiah Nagar, MSRIT Post, Bangalore
→ | kirtijoshi@msrmc.ac.in→ | 9686851063→ | MS Ramaiah Medical College→ | Inclusion criteria: Parents should understand english→ | Exclusion criteria: Children with any major surgery/ major illiness requiring hospitilisation including COVID-19 infection→ | | | Change in functional health statusTimepoint: only once→ | | | | Yes | False | | |
| → | CTRI/2021/08/036080 | 7 September 2021 | A questionnaire-based study to examine the impact of the COVID-19 pandemic on contact lens wearers | The impact of the pandemic of COVID-19 on contact lens users - a questionnaire-based study | | Manipal college of health professions | 31-08-2021 | 20210831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59870 | Not Recruiting | No | | | | 20-09-2021 | 289 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India→ | Premjit bhakat→ | | Dept. of Optometry, Manipal College of health Professions,
Manipal Academy of Higher Education, Manipal → | premjit.bhakat@manipal.edu→ | 9742503244→ | Manipal college of health professions.→ | Inclusion criteria: Existing Contact lens users <br/ ><br>Age group 18 years and above <br/ ><br>Contact lens user from 2019 or before (minimum one year of contact lens use) <br/ ><br>→ | Exclusion criteria: Therapeutic users <br/ ><br>Occasional contact lens users <br/ ><br>Previous ocular surgery <br/ ><br>Eye disease â?? dry eye disease, infection and inflammation related disease <br/ ><br>Neurological disease â?? optic neuritis, night or day blindness, color blindness. <br/ ><br>→ | | Intervention1: NIL: NIL<br>→ | Frequency/number of people reported, Behavior, attitude, and concerns of the contact lens users.Timepoint: The questionnaire will be administrated at one point of the study.→ | | | | Yes | False | | |
| → | CTRI/2021/08/036089 | 7 September 2021 | Clinical Study on Lupinâ??s Ayurvedic Nasal Spray in COVID-19 patients and household contacts | Multi-center, randomized, parallel-group, comparative, open-label study to evaluate the efficacy and safety of Lupinâ??s Ayurvedic Nasal Spray in subjects diagnosed with COVID-19 and household contacts - NIL | | Lupin Ltd | 31-08-2021 | 20210831 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60057 | Recruiting | No | | | | 08-09-2021 | 150 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2/ Phase 3 | India→ | Dr Sanjay Tamoli→ | | Target Institute of Medical Education and Research
A wing, 402-A/B/C, Jaswanti Allied business center, Ramchandra lane extension, Kachpada, Malad west, Mumbai
→ | targetinstitute@yahoo.com→ | 9322522252→ | Target Institute of Medical Education and Research→ | Inclusion criteria: 1. Capable of understanding and providing signed informed consent and ability to adhere to the requirements and restrictions of this protocol. <br/ ><br>2. Subjects with mild COVID-19 symptoms (only for Treatment Group). Subjects with uncomplicated upper respiratory tract infection (without shortness of breath or hypoxia [normal saturation i.e. SpO2 levels â?¥94%]), may have mild grade of fever ( <1000 C), cough, sore throat, nasal congestion, malaise and headache. <br/ ><br>3. Participants staying with COVID-19 subject in the same household (only for Prevention Group). <br/ ><br>4. Participants who have tested positive for RT-PCR (for treatment group only) and negative for RT-PCR (for prevention group only) within 5 days of enrollment <br/ ><br>→ | Exclusion criteria: 1. Subjects with moderate to severe disease <br/ ><br>2. Subjects requiring or likely requiring oxygen support in the opinion of investigator <br/ ><br>3. Any clinical contraindications, as judged by the investigator <br/ ><br>4. Pregnant or lactating females <br/ ><br>5. Subjects with prior history of confirmed COVID-19 infection with RT-PCR in last 3 months. <br/ ><br>6. Subjects who are currently hospitalized or need for hospitalization <br/ ><br>7. Subjects with blocked nose requiring intranasal decongestant <br/ ><br>8. Any history of underlying uncontrolled medical illness (such as diabetes, hypertension, liver disease or history of alcoholism, HIV or any other serious medical illness) <br/ ><br>→ | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
→ | | 1. Change in SARS-CoV-2 viral load from baseline to day 7 and 14 (measured by RT-PCR/q-PCR) in treatment group. <br/ ><br>2. Proportion of subjects with viral negativity measured by RT-PCR on day 14 in prevention group <br/ ><br>Timepoint: Screening Visit (Up to 5 days), Baseline Visit (Day 0), Day 7, and day 14.→ | | | | Yes | False | | |
| NCT03305341 | 13 September 2021 | Proof-of-Concept Clinical Pharmacology Trial for COVID-19 Antigen Presentation Therapeutic Biologics | Conducting an Initial Small, Controlled Clinical Pharmacology Trial to Assess for Therapeutic Biologics Activity (Proof-of-Concept) That Suggests the Potential for Clinical Benefits of COVID-19 Patients. | COV19-APTP-B | Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair | 04/10/2017 | 20171004 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT03305341 | Not recruiting | No | 22 Years | 72 Years | All | July 18, 2020 | 20 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Early Phase 1 | United States | ; ; | HAN XU, M.D., Ph.D.;HAN XU, M.D., Ph.D.;HAN XU, M.D., Ph.D. | | ;; | ;; | Medicine Invention Design, Inc. (MIDI) - IORG0007849;Medicine Invention Design, Inc. (MIDI) - IORG0007849;Medicine Invention Design, Inc. (MIDI) - IORG0007849 |
<br> - Conducting an initial small, controlled trial to assess for therapeutic biologics
<br> activity (proof-of-concept) that suggests the potential for clinical benefit of
<br> COVID-19 patients.
<br>
<br> - 20 Moderate COVID-19 patients
<br>
<br> Inclusion Criteria:
<br>
<br> - Moderate COVID-19
<br>
<br> - Positive testing by standard RT-PCR assay or equivalent testing
<br>
<br> - Symptoms of moderate illness with COVID-19, which could include any symptom of mild
<br> illness or shortness of breath with exertion
<br>
<br> - Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate
<br> = 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level,
<br> heart rate = 90 beats per minute
<br>
<br> - No clinical signs indicative of Severe or Critical Illness Severity
<br>
<br> Exclusion Criteria:
<br>
<br> - 1. Severe or Critical Illness Severity
<br>
<br> - 2. Pregnancy
<br>
<br> - 3. Breast-feeding
<br>
<br> - 4. The patients with other serious inter-current illness
<br>
<br> - 5. Serious Allergy
<br>
<br> - 6. Serious Bleed Tendency
<br>
<br> - 7. The prohibition of the biological product
<br> | | Covid19 | Biological: COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection | Rate of Negative COVID-19 nucleic acid;Concentration of Active Ingredient:;Rate of Positive COVID-19 nucleic acid:;Number of Participants with Moderate COVID-19: | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04453657 | 13 September 2021 | Tele-Wellness Supported App for Family Child Care Home Providers and Families to Promote Health, Family Engagement, and School Readiness Amid COVID-19 | Adapting and Delivering a Tele-Wellness Supported Digital Toolkit to Baltimore City's Approved Family Child Care Home Providers Caring for Children of Essential Workers: Promoting Health, Early Literacy, and Quality Parent Engagement Amid COVID-19: A Pilot Study | | Johns Hopkins University | 26/06/2020 | 20200626 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04453657 | Recruiting | No | 3 Years | 99 Years | All | February 4, 2021 | 270 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | United States | | Lucine Francis, PhD | | | | Johns Hopkins University |
<br> Inclusion Criteria:
<br>
<br> - Licensed Family Child Care Home Providers operating in Baltimore City who are approved
<br> or was once approved to remain open during COVID-19 through the Essential Personnel
<br> Child Care or School-Aged Program.
<br>
<br> - Parents or legal adult guardians of young children (3-6 years old) who have utilized
<br> or continue to utilize the services of Family Child Care Home providers enrolled in
<br> the study.
<br>
<br> - All participants must have access to a smartphone, tablet, or computer.
<br>
<br> Exclusion Criteria:
<br>
<br> - Licensed Family Child Care Home Providers not enrolled or was never enrolled in the
<br> Essential Personnel Child Care or School-Aged Program
<br>
<br> - Parents of young children (3-6 years old) who have not utilized the services of
<br> Licensed Family Child Care Home Providers in the Essential Personnel Child Care or
<br> School-Aged Program
<br>
<br> - FCCH providers not operating in Baltimore City
<br>
<br> - FCCH providers who do not have at least 1 parent consenting to participate in the
<br> study.
<br> | | Stress, Psychological;Child Behavior;Social Competence | Device: FamilyChildCare (provisional name of app) | Change in Perceived Level of Stress as assessed by the Perceived Stress Scale;Change in Perceived Level of Informational Support as assessed by the PROMIS Informational Support Short Form;Change in Awareness of the Maryland Early Childhood Family Engagement Framework and Toolkit as assessed by a survey question;Change in Social, Emotional, and Behavior Functioning in Children as assessed by the Social Competence and Behavior Evaluation for Children | | | | Yes | False | | |
| → | NCT04459689 | 13 September 2021 | COVID-19 in PID Survey | Worldwide COVID-19 in Children and Adult Patients With Primary ImmunoDeficiencies (PID) Survey | COPID19 | Imagine Institute | 02/07/2020 | 20200702 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04459689 | Recruiting | No | N/A | N/A | All | March 15, 2020 | 200 | Observational [Patient Registry] | | | France | ; ; | Nizar MAHLAOUI, MD, MPH, PhD;Nizar MAHLAOUI, MD, MPH, PhD;Nizar MAHLAOUI, MD, MPH, PhD | | ;nizar.mahlaoui@aphp.fr;nizar.mahlaoui@aphp.fr | ;+33144494622;+33144494622 | Necker Enfants Malades University Hospital; |
<br> Inclusion Criteria:
<br>
<br> - Diagnosed with a Primary Immune Deficiency
<br>
<br> - COVID-19 (proven or probable)
<br>
<br> Exclusion Criteria:
<br>
<br> - Secondary Immune Deficiency
<br>
<br> - Other Coronovirus infection
<br> | | Primary Immune Deficiency;COVID | | Survival of patients with PID affected by COVID-19;Rate of admission to ICU of patients with PID affected by COVID-19;Rate of oxygen therapy of patients with PID affected by COVID-19→Rate of oxygen therapy of patients with PID affected by COVID-19;Rate of admission to ICU of patients with PID affected by COVID-19;Survival of patients with PID affected by COVID-19 | | | | Yes | False | | |
| NCT04460690 | 13 September 2021 | Rapid, Onsite COVID-19 Detection | Rapid, Onsite COVID-19 Detection | | University of Wisconsin, Madison | 06/07/2020 | 20200706 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04460690 | Not recruiting | No | 5 Years | N/A | All | July 13, 2020 | 93 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | United States | | David O'Connor, PhD | | | | University of Wisconsin, Madison |
<br> Inclusion Criteria:
<br>
<br> - Willing to provide informed consent
<br>
<br> - Willing to provide informed consent and spit into a vessel
<br>
<br> - Individuals at least 5 years of age and have a parent or legal guardian present to
<br> consent if under 18 years
<br>
<br> - Adult participants must have decision-making capacity to provide consent on their own
<br> behalf.
<br>
<br> - Participants must be able to speak English
<br>
<br> Exclusion Criteria:
<br>
<br> - Under 18 years of age with no parent or legal guardian present or under the age of 5
<br> yrs
<br>
<br> - Participants must not have visual or hearing impairments, or low literacy, that would
<br> prevent them from reading the consent form and interacting with a member of the
<br> research team to ask questions and receive responses during the consent process
<br> | | COVID-19;Sars-CoV2 | Device: Rapid Onsite COVID-19 Detection | Number of Samples Tested Consistently and Accurately per Protocol;Safety: COVID-19 rates of Investigators vs Communities tested | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04500366 | 13 September 2021 | GERAS Frailty Rehabilitation at Home During COVID-19 | GERAS Frailty Rehabilitation at Home: Virtual Bundled Care for Seniors Who Are Frail to Build Strength and Resilience During COVID-19 | | McMaster University | 31/07/2020 | 20200731 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04500366 | Not recruiting | No | 65 Years | N/A | All | August 26, 2020 | 70 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Investigator, Outcomes Assessor). | N/A | Canada | | Alexandra Papaioannou, MD, MSc | | | | Scientific Director, GERAS Centre for Aging Research |
<br> Inclusion Criteria:
<br>
<br> - Community-dwelling adults aged = 65 years of age;
<br>
<br> - Score between 4-6 (inclusive) on the clinical frailty scale;
<br>
<br> - Able to ambulate independently with or without a walking aid; OR with caregiver
<br> supervision at home;
<br>
<br> - Obtain clearance for exercise: For hospital referrals - average resting heart rate
<br> between 50-100 bpm and average blood pressure less than or equal to 160/90mmHg (as per
<br> Canadian Society for Exercise Physiology guidelines for exercise clearance); OR Self-
<br> referrals: Obtain exercise clearance from their family physician prior to the first
<br> intervention session.
<br>
<br> Exclusion Criteria:
<br>
<br> - Unable to speak or understand English and has no caregiver for translation;
<br>
<br> - Significant cognitive impairment where they may have difficulty following two-step
<br> commands;
<br>
<br> - Receiving palliative/end of life care;
<br>
<br> - Unstable angina or unstable heart failure;
<br>
<br> - Travel plans that would result in missing greater than 20% of the trial's 12-week
<br> duration;
<br>
<br> - Currently attending a group exercise program.
<br> | | Frailty | Behavioral: Socialization;Behavioral: Virtual Group Exercise;Combination Product: Nutrition Consult and Protein Supplementation;Behavioral: Medication Review | Change in Mental Health;Change in Physical Function | | | | Yes | False | | |
| → | NCT04505098 | 13 September 2021 | A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults | A Pragmatic Randomized Trial of Icosapent Ethyl for High-Cardiovascular Risk Adults (MITIGATE) | MITIGATE | Kaiser Permanente | 05/08/2020 | 20200805 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04505098 | Recruiting | No | 50 Years | N/A | All | August 7, 2020 | 16500 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). | Phase 4 | United States | ; ; ; | Andrew Ambrosy, M.D.;Alan S Go, M.D.;Alan S Go, M.D.;Alan Go, MD | | ;;alan.s.go@kp.org; | ;;510-891-3422; | Kaiser Permanente;Kaiser Permanente; |
<br> Inclusion Criteria:
<br>
<br> - Able to provide informed consent (for the intervention arm only)
<br>
<br> - No prior history of confirmed COVID-19 (i.e., based on a positive FDA-approved assay
<br> for SARS-CoV-2 and no documented FDA-approved serological test results for antibodies
<br> to SARS-CoV-2 found in health system databases)
<br>
<br> - Established ASCVD (i.e., defined as prior myocardial infarction, percutaneous coronary
<br> intervention, coronary artery bypass surgery, ischemic stroke, and/or peripheral
<br> artery disease)
<br>
<br> - At least 12 months of continuous health plan membership and prescription drug benefit
<br> prior to enrollment
<br>
<br> - A registered e-mail address with the health care delivery system in order to
<br> facilitate obtaining electronic consent for study participation
<br>
<br> Exclusion Criteria:
<br>
<br> - Receipt of IPE on or within 12 months before the day of enrollment
<br>
<br> - Known hypersensitivity to IPE, fish, and/or shellfish
<br>
<br> - Documented use of any omega-3 fatty acid medications or dietary supplements containing
<br> omega-3 fatty acids in the EHR
<br>
<br> - Women who are pregnant or planning to become pregnant
<br>
<br> - Hospitalization for myocardial infarction and/or elective percutaneous coronary
<br> intervention within the past 1 month
<br>
<br> - Currently receiving triple anti-thrombotic therapy
<br>
<br> - Stage D heart failure
<br>
<br> - Severe liver disease
<br>
<br> - End-stage renal disease requiring chronic dialysis or estimated glomerular filtration
<br> rate <15 mL/min/1.73 m2
<br>
<br> - Metastatic cancer and/or receiving active systemic chemotherapy
<br>
<br> - Institutionalized and/or receiving palliative care
<br> | | Covid19;Atherosclerosis;Cardiovascular Diseases;Upper Respiratory Tract Infections | Drug: Icosapent ethyl | Percentage of patients with moderate or severe confirmed viral URIs;Worst clinical status due to a confirmed viral URI→Worst clinical status due to a confirmed viral URI;Percentage of patients with moderate or severe confirmed viral URIs | | | | Yes | False | | |
| NCT04519216 | 13 September 2021 | Breastfeeding Education in the Time of COVID-19 | Breastfeeding Education in the Time of COVID-19. Hybrid Telesimulation With Standardized Patients for Pediatric and Family Medicine Trainees, a Randomized Trial | | University of California, Davis | 12/08/2020 | 20200812 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04519216 | Not recruiting | No | 18 Years | N/A | All | July 31, 2020 | 39 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor). | N/A | United States | | Adrienne Hoyt-Austin, DO | | | | University of California, Davis |
<br> 1. Inclusion Criteria: Pediatric and Family Medicine resident physicians at UC Davis
<br> Medical Center
<br>
<br> 2. Exclusion criteria: Individuals who are unable to communicate in English, Individuals
<br> who do not have access to videoconferencing via computer or phone.
<br> | | Breastfeeding;Breastfeeding, Exclusive;Breastfeeding Jaundice;Educational Problems | Behavioral: Telesimulation | Change in practice patterns | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05033860 | 13 September 2021 | The Influence of Education During Waiting Time of Vaccination on the Knowledge Towards COVID-19 Among Chinese Residents | The Influence of Education During Waiting Time of Vaccination on the Knowledge Towards COVID-19 Among Chinese Residents: A Randomized Controlled Trial | | Ningbo No. 1 Hospital | 30/08/2021 | 20210830 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05033860 | Recruiting | No | 18 Years | N/A | All | August 18, 2021 | 312 | Interventional | Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: Single (Participant). | N/A | China | ; | Lei Xu, MD;Lei Xu | | xulei22@163.com;xulei22@163.com | +86-13486659126;13486659126 | |
<br> Inclusion Criteria:
<br>
<br> 1. Age =18;
<br>
<br> 2. Residents who are vaccinated with COVID-19 vaccines at Xidian Passenger Station from
<br> August 18th to September 20th, 2021;
<br>
<br> 3. Able to understand the content of leaflets and questionnaires, and willing to
<br> participate in the study.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Residents who are unable to get vaccinated with COVID-19 vaccines;
<br>
<br> 2. Unable to understand the content of leaflets and questionnaires, or unwilling to
<br> participate in the study;
<br>
<br> 3. Unreturned or incomplete questionnaires.
<br> | | Covid19;Knowledge, Attitudes, Practice | Other: Read leaflets containing knowledge of COVID-19 and vaccination. | Scores of the questionnaire | | | | Yes | False | | |
| → | NCT05035238 | 13 September 2021 | Evaluation of the Efficacy, Safety and Immunogenicity of Inactivated COVID 19 Vaccine(TURKOVAC) in Healthy Population of 18 and 64 Years of Age (Both Inclusive):a Randomized, Double-blind, Phase IIb Clinical Trial | Evaluation of the Efficacy, Safety and Immunogenicity of Inactivated COVID 19 Vaccine (TURKOVAC Inactive) in Healthy Population of 18 and 64 Years of Age (Both Inclusive): a Randomized, Double-blind, Phase IIb Clinical Trial | | Health Institutes of Turkey | 01/09/2021 | 20210901 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05035238 | Not recruiting | No | 18 Years | 64 Years | All | September 20, 2021 | 200 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor). | Phase 2 | Turkey | ; | ZAFER SEZER;ZAFER SEZER | | ;drzafersezer@gmail.com | ;+90352 207 66 66 | Erciyes University Hakan Çetinsaya Iyi Klinik Uygulama ve Arastirma Merkezi, IKUM (Center for GCP); |
<br> Inclusion criteria:
<br>
<br> 1. Caucasian race, 18 to 64 years of age male or female (both inclusive),
<br>
<br> 2. accepting not to participate in another COVID-19 vaccine study until the end of the
<br> study,
<br>
<br> 3. voluntarily gives written informed consent prior to any study-related procedures.
<br>
<br> 4. has a Body Mass Index (BMI) of 18.5-32.0 kg/m2-both inclusive,
<br>
<br> 5. has a normal/acceptable ECG result
<br>
<br> 6. for female volunteers of childbearing potential, a negative serum pregnancy test
<br> within seven days before vaccination:
<br>
<br> - Females of childbearing potential are defined as fertile following menarche and
<br> until becoming postmenopausal or permanently sterile. (Postmenopausal is defined
<br> as absence of vaginal bleeding or spotting for at least one year. Permanently
<br> sterile is defined as having had a hysterectomy, bilateral salpingectomy, or
<br> bilateral oophorectomy.)
<br>
<br> 7. for female volunteers of childbearing potential, volunteers who do not plan to get a
<br> child in the next one year; a willingness to use highly effective* contraceptive
<br> measures adequate to prevent a new pregnancy for the duration of the study, including
<br> for at least 12 months after receiving the first dose of study vaccination. For women
<br> with reproductive potential who use a hormonal method of contraception, concurrent use
<br> of a second (barrier) method is recommended.
<br>
<br> * Highly effective methods of birth control are defined as those that result in a low
<br> failure rate (i.e. less than 1% per year) when used consistently and correctly (e.g.
<br> implants, injectables, oral contraceptives, some intrauterine devices, bilateral tubal
<br> occlusion, true sexual abstinence in line with the preferred and usual lifestyle of
<br> the volunteer, or vasectomized partner).
<br>
<br> 8. for sexually active males, a willingness to use contraceptive measures, e.g. a condom,
<br> for the duration of the study, including for at least three months after receiving the
<br> last dose of study vaccination. In addition, males must agree not to donate sperm over
<br> the same study period and for at least three months after receiving the last dose of
<br> study vaccination.
<br>
<br> 9. anti-SARS CoV 2 total antibody (including COVID-19 IgG and/or IgM) negative in serum.
<br>
<br> 10. physical examination, if indicated only (general state and abnormal findings per
<br> system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears,
<br> nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary,
<br> urogenital, musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should
<br> be normal/acceptable.
<br>
<br> Exclusion criteria:
<br>
<br> 1. clinically significant infection or other acute illness not due to SARS-CoV-2,
<br> including fever = 37.4°C within 24 hours prior to the planned study vaccination.
<br>
<br> 2. had close contact to persons with confirmed SARS-CoV-2 infection within 14 days prior
<br> to screening Visit 1.
<br>
<br> 3. has participated in a clinical study involving an investigational SARS-CoV-2 vaccine.
<br>
<br> 4. has a history of SARS-CoV-1 or MERS infection (self-reported).
<br>
<br> 5. positive test results for human immunodeficiency virus (HIV), hepatitis B surface
<br> antigen (HBsAg) or hepatitis C virus (HCV).
<br>
<br> 6. has received any vaccine within 30 days prior Visit 1 other than the study
<br> intervention, with the exception of the seasonal influenza vaccination.
<br>
<br> 7. has abnormal findings in any required study investigations (including medical history,
<br> vital signs, physical examination, and clinical laboratory) considered clinically
<br> relevant by the Investigator.
<br>
<br> 8. with either medical history of or present acute or progressive, unstable or
<br> uncontrolled clinical conditions that pose a risk for participation or completion of
<br> the study, based on Investigator's clinical judgement.
<br>
<br> 9. with underlying diseases with a high risk of developing severe COVID-19 symptoms if
<br> infected.
<br>
<br> 10. has a history of malignancy in the past five years other than squamous cell or basal
<br> cell skin cancer. If there has been surgical excision or treatment more than five
<br> years ago that is considered to have achieved a cure, the subject may be enrolled. A
<br> history of hematologic malignancy is a permanent exclusion. Subjects with a history of
<br> skin cancer must not be vaccinated at the previous tumor site.
<br>
<br> 11. has a known or suspected defect of the immune system, such as subjects with congenital
<br> or acquired immune deficiency.
<br>
<br> 12. received immuno-suppressive therapy within four weeks prior to Visit 1 or receipt of
<br> immunosuppressive therapy is expected during the study.
<br>
<br> 13. has a history of any vaccine related contraindicating event.
<br>
<br> 14. presents with clinical conditions representing a contraindication to intramuscular
<br> vaccination and blood draws.
<br>
<br> 15. has donated blood, blood fractions or plasma within four weeks prior to Visit 1 or
<br> received blood-derived products (e.g., plasma) within 12 weeks prior to Visit 1 in
<br> this study or plans to donate blood or use blood products during the study.
<br>
<br> 16. with clinically significant bleeding disorder (e.g., factor deficiency, coagulopathy
<br> or platelet disorder) or prior history of significant bleeding or bruising following
<br> IM injections or venipuncture.
<br>
<br> 17. has a rash, dermatological condition or tattoos that would, in the opinion of the
<br> Investigator, interfere with injection site reaction rating.
<br>
<br> 18. has a known or suspected problem with alcohol, caffeine or drug abuse as determined by
<br> the Investigator.
<br>
<br> 19. has any condition that, in the opinion of the Investigator, may compromise the
<br> subject's well-being, might interfere with evaluation of study endpoints, or would
<br> limit the subject's ability to complete the study.
<br>
<br> 20. has participated in another clinical study involving an investigational medicinal
<br> product (IMP) or device within 4 weeks prior to Visit 1 or is scheduled to participate
<br> in another clinical study involving an IMP, or device during this study.
<br>
<br> 21. blood pressure, after resting for five min, higher than 140/90 or lower than 100/60 mm
<br> Hg.
<br>
<br> 22. pulse rate outside the range of 50 - 100 beats/min OR respiratory rate outside the
<br> range of 15 - 18 breathings /min, after resting for five min.
<br>
<br> 23. laboratory values (blood/serum examination: sodium, potassium, calcium, total protein,
<br> albumin, glucose, creatinine, BUN, total bilirubin, AST, ALT, GGT, ALP, hemoglobin,
<br> hematocrit, erythrocytes, leukocytes, platelet count; HBsAg, HIV-Ab, HCV-Ab,
<br> urinalysis if requested) outside normal range with clinical relevance at entry.
<br>
<br> | | Covid19 | Biological: Triple dose vaccination by inactivated Covid19 vaccine | Efficacy outcome;Efficacy Outcome;Efficacy Outcome;Efficacy Outcome→Efficacy Outcome;Efficacy Outcome;Efficacy Outcome;Efficacy outcome | | | | Yes | False | | |
| NCT05035524 | 13 September 2021 | A Randomized Controlled Trial to Investigate The Role of Adjuvant Inhalable Sodium Bicarbonate Solution 8.4% in Treatment of COVID-19 | A Randomized Controlled Trial to Investigate The Role of Adjuvant Inhalable Sodium Bicarbonate Solution 8.4% in Treatment of COVID-19 | | Mansoura University | 02/09/2021 | 20210902 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05035524 | Not recruiting | No | 18 Years | N/A | All | September 1, 2021 | 340 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Egypt | ; ; ; ; | Tamer El-Hadidy;Rehab Ahmad Elmorsey;Ibrahim Badr;Mohammed shehta;Adel El-Badrawy | | ;;;; | ;;;; | Mansoura University Hospital - Chest Departement;Mansoura University Hospital - Chest Departement;Mansoura University Hospital - Chest Departement;Mansoura University Hospital - Chest Departement;Mansoura University Hospital - Chest Departement |
<br> Inclusion Criteria:
<br>
<br> - all consecutive patients suspected as COVID-19 presented to the respiratory evaluation
<br> zone and outpatient clinic of our university will be subjected to RT-PCR test for
<br> COVID.
<br>
<br> - Patients proved to be RT-PCR positive will be included in the present study.
<br>
<br> Exclusion Criteria:
<br>
<br> - pregnant ladies
<br>
<br> - who will refuse enrollment or discontinue follow up.
<br> | | COVID-19 Pneumonia;Covid19;COVID-19 Acute Respiratory Distress Syndrome | Drug: Sodium Bicarbonate Solution;Drug: Placebo | The time interval to recovery defined as the first day | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05037019 | 13 September 2021 | SIGNAL During a COVID-19 Pandemic | Single Fraction Preoperative Radiation as a Strategy for Local Control of Breast Cancer During a COVID-19 Pandemic | | Muriel Brackstone | 05/05/2020 | 20200505 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05037019 | Not recruiting | No | 50 Years | N/A | Female | May 2020 | 0 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | | | Muriel Brackstone, MD, PhD | | | | Lawson Health Research Institute |
<br> Inclusion Criteria:
<br>
<br> - Female sex
<br>
<br> - Age = 50 years old
<br>
<br> - Postmenopausal
<br>
<br> - Tumor size < 3cm on pre-treatment imaging
<br>
<br> - Any grade of disease, estrogen receptor (ER) positive, HER2 negative
<br>
<br> - Unicentric/unifocal disease
<br>
<br> - Invasive ductal carcinoma or other favorable subtypes of epithelial breast malignancy
<br> (lobular, medullary, papillary, colloid, mucinous, or tubular) .
<br>
<br> - Clinically node-negative (based upon pre-treatment physical examination and/or
<br> axillary ultrasound).
<br>
<br> - Surgical expectation that a > 2mm margin can be obtained.
<br>
<br> - Lesion is 1 cm or greater from the skin surface.
<br>
<br> - Able to lie comfortably in the prone position with arms raised above the head for
<br> extended periods of time.
<br>
<br> Exclusion Criteria:
<br>
<br> - Male sex
<br>
<br> - Under 50 years of age
<br>
<br> - Previous RT to the same breast
<br>
<br> - HER2 positive disease
<br>
<br> - Evidence of suspicious diffuse microcalcifications in the breast prior to the start of
<br> radiation.
<br>
<br> - Local metastatic spread into ipsilateral axilla and/or supraclavicular region and/or
<br> neck nodes and/or internal mammary nodes diagnosed on clinical examination or any
<br> imaging assessment (unless such sites can be confirmed as negative following biopsy)
<br>
<br> - Distant metastases
<br>
<br> - Involvement of contralateral axillary, supraclavicular, infraclavicular or internal
<br> mammary nodes (unless there is histologic confirmation that these nodes are negative)
<br>
<br> - Prior non-hormonal therapy or radiation therapy for the current breast cancer
<br>
<br> - Patients with Paget's disease of the nipple.
<br>
<br> - Skin involvement, regardless of tumor size.
<br>
<br> - Patients with a breast technically unsatisfactory for radiation therapy.
<br>
<br> - Inability to lie prone with arms raised above head for extended periods of time.
<br>
<br> - Patients not appropriate for BCS due to expectation of poor cosmetic result, even
<br> without RT
<br>
<br> - Collagen vascular disease (particularly lupus, scleroderma, dermatomyositis)
<br>
<br> - Inability or unwillingness to provide informed consent.
<br>
<br> - Any other malignancy at any site (except non-melanomatous skin cancer) < 5 years prior
<br> to study enrollment
<br>
<br> - Patients who are pregnant or lactating
<br> | | Breast Cancer | Procedure: Radiation therapy | Feasibility of SBRT during a pandemic;Pathologic complete response (pCR) | | | | Yes | False | | |
| → | NCT05037162 | 13 September 2021 | Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19 | A Phase IIb, Double Blind, Placebo-controlled Clinical Study Designed to Evaluate the Effect of CimetrA in Patients Diagnosed With COVID-19 | CimetrA | MGC Pharmaceuticals d.o.o | 15/08/2021 | 20210815 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05037162 | Not recruiting | No | 18 Years | N/A | All | September 2021 | 240 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2 | Israel | ; | Rita Nadaf;Dr. Nadia Lisovoder | | ;nadyal@galilee-cbr.com | ;+972529573063 | Galilee CBR - CRO; |
<br> Inclusion Criteria:
<br>
<br> 1. Confirmed by PCR test SARS-CoV-2 infection (according to nationally authorized
<br> laboratory criteria)
<br>
<br> 2. Hospitalized patient with COVID-19 of moderate stable or worsening severity not
<br> requiring ICU admission (defined by NIH criteria - fever, cough, dyspnea, fast
<br> breathing, but no signs of severe pneumonia, including SpO2 = 94% on room air).
<br>
<br> 3. Age: 18 years old and above.
<br>
<br> 4. Subjects must be hospitalized
<br>
<br> 5. Ability to receive treatment by spray into the oral cavity
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Tube feeding or parenteral nutrition.
<br>
<br> 2. Patients with scores 5 or above per the Ordinal Scale for Clinical Improvement
<br> published by the WHO. (i.e., who need oxygen supply beyond use of nozzles or simple
<br> mask)
<br>
<br> 3. Need for admission to ICU during the present hospitalization at any time prior to
<br> completion of the recruitment to the study.
<br>
<br> 4. Any condition which, in the opinion of the Principal Investigator, would prevent full
<br> participation in this trial or would interfere with the evaluation of the trial
<br> endpoints.
<br> | | Covid19;Corona Virus Infection | Diagnostic Test: Biochemistry blood test;Diagnostic Test: Hematology blood test;Diagnostic Test: D-Dimer test (coagulation);Diagnostic Test: Inflammatory markers;Diagnostic Test: Vital signs;Diagnostic Test: VAS scale;Diagnostic Test: WHO Ordinal Score;Diagnostic Test: COVID-19-Related Symptoms assessment;Diagnostic Test: COVID-19-Impact on Quality-of-Life Questionnaire;Diagnostic Test: POST- COVID-19 Functional Status Scale:;Diagnostic Test: Pregnancy test;Diagnostic Test: Physical examination;Diagnostic Test: PK parameters;Diagnostic Test: SARS-CoV-2 test (PCR);Diagnostic Test: ECG;Drug: Treatment administration (twice a day) | Change in WHO Ordinal Scale for clinical improvement;Change in COVID-19-Related Symptoms score;Safety endpoint: will be assessed through collection and analysis of adverse events;Safety endpoint: will be assessed through collection and analysis of blood laboratory test.;Safety endpoint: will be assessed through collection and analysis of urine laboratory test.;Safety endpoint: will be assessed through collection and analysis of blood preasure;Safety endpoint: will be assessed through collection and analysis of blood satturation;Safety endpoint: will be assessed through collection and analysis of body temperature→Safety endpoint: will be assessed through collection and analysis of body temperature;Safety endpoint: will be assessed through collection and analysis of blood satturation;Safety endpoint: will be assessed through collection and analysis of blood preasure;Safety endpoint: will be assessed through collection and analysis of urine laboratory test.;Safety endpoint: will be assessed through collection and analysis of blood laboratory test.;Safety endpoint: will be assessed through collection and analysis of adverse events;Change in COVID-19-Related Symptoms score;Change in WHO Ordinal Scale for clinical improvement | | | | Yes | False | | |
| NCT05040659 | 13 September 2021 | Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2 | Longitudinal At Home Smell Testing to Detect Infection by SARS-CoV-2 | | Massachusetts General Hospital | 18/08/2021 | 20210818 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05040659 | Not recruiting | No | 18 Years | 100 Years | All | October 1, 2021 | 6000 | Observational [Patient Registry] | | | United States | ; ; | Mark W Albers, MD PhD;Mark W Albers, MD PhD;Mark W Albers, MD PhD | | ;albers.mark@mgh.harvard.edu;albers.mark@mgh.harvard.edu | ;617-724-7401;617-724-7401 | Massachusetts General Hospital; |
<br> For anosmic patients/healthy controls:
<br>
<br> Inclusion criteria
<br>
<br> 1. Known anosmia (for anosmic patients only)
<br>
<br> 2. Age greater than or equal to 18
<br>
<br> 3. Access to phone, tablet or computer connected to the internet.
<br>
<br> Exclusion criteria
<br>
<br> 1. Known odor-evoked adverse effects, e.g. asthma.
<br>
<br> 2. No known history of SARS-CoV-2 and or other respiratory illness (healthy controls
<br> only)
<br>
<br> For asymptomatic participants:
<br>
<br> Inclusion criteria
<br>
<br> 1. No symptoms of COVID infection at the time of enrollment.
<br>
<br> 2. Age greater than or equal to 18
<br>
<br> 3. Access to phone, tablet or computer connected to the internet.
<br>
<br> Exclusion criteria
<br>
<br> 1. Known odor-evoked adverse effects, e.g. asthma.
<br>
<br> 2. Prior known smell or taste disorder
<br>
<br> For symptomatic patients:
<br>
<br> Inclusion criteria
<br>
<br> 1. Potential or definite exposure to SARS-CoV-2 virus
<br>
<br> 2. Symptoms of upper respiratory infection (smell loss, taste loss, fever, myalgia,
<br> cough, nasal congestion, runny nose, shortness of breath)
<br>
<br> 3. Age greater than or equal to 18
<br>
<br> 4. Access to phone, tablet or computer connected to the internet.
<br>
<br> Exclusion criteria
<br>
<br> 1. Known odor-evoked adverse effects, e.g. asthma.
<br>
<br> 2. Prior known smell or taste disorder
<br> | | Anosmia;Asymptomatic COVID-19;COVID-19 Respiratory Infection;Influenza | Device: AROMHA Longitudinal Smell Test | Aromha Longitudinal Smell Test;Aromha Longitudinal Smell Test | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2021-003386-35-ES | 13 September 2021 | Vaccination for Recovered Inpatients with COVID-19 (VATICO) | SARS-CoV-2 vaccination strategies in previous hospitalised and recovered COVID-19 patients - VATICO | | Regents of the University of Minesota | 26/07/2021 | 20210726 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-003386-35 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 03/09/2021 | 640 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Randomisation to one of the 4 treatment groups will depend on the treatment in TICO study<br>Number of treatment arms in the trial: 4<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Sweden;United Kingdom;Georgia;Peru;Uganda;Denmark;Singapore;Ukraine;Spain;Nigeria;United States | Jens Lundgren | | Blegdamsvej 9 | jens.lundgren@regionh.dk | 453545 5757 | CHIP - Rigshospitalet, University of Copenhagen | Inclusion criteria: <br>1. Participating in the TICO trial and received a selected blinded investigational agent or placebo for that agent at selected sites. <br>NOTE: A list of selected investigational agents will be posted on the INSIGHT website.<br><br>2. Willingness to strictly adhere to the randomly allocated dosage number and schedule for vaccine administration<br>3. Participant is between Day 28 and Day 90 TICO visits inclusive at the time of randomization<br>4. At the time of screening for this protocol, experienced sustained recovery (i.e. the primary endpoint in TICO) for at least two consecutive weeks, i.e. having returned uninterrupted to the person’s premorbid living facility (or equivalent) for at least 2 consecutive weeks<br>5. Ability and willingness of participant (or legally authorized representative [LAR]) to provide informed consent prior to initiation of any study procedures<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 640<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 300<br> | Exclusion criteria: <br>1. Receipt of a SARS-CoV-2 (also known as COVID-19) vaccine after enrollment into TICO. Participants who received a SARS-CoV-2 vaccine prior to enrollment in TICO may be enrolled in this substudy<br><br>2. Known allergy to any component of the study eligible vaccine(s)<br> | Participants of the ACTIV-3/TICO clinical trial at selected sites who received certain pre-specified blinded investigational agents or placebo as part of that trial, and who have since achieved sustained recovery, and who are still [TICO assignment] blinded, and who are still within 28 to 90 days after initial TICO randomization, will be randomized in this 2x2 factorial design to one of four groups of the Moderna mRNA 1273 or the Pfizer BNT162b2 vaccine (mRNA vaccines) <br>MedDRA version: 23.1
Level: LLT
Classification code 10084465
Term: COVID-19 vaccination
System Organ Class: 100000004865
;Therapeutic area: Health Care [N] - Environment and Public Health [N06] | <br>Trade Name: COMIRNATY<br>concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)<br>Pharmaceutical Form: Concentrate for solution for injection<br>INN or Proposed INN: COMIRNATY<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br>Trade Name: Spikevax dispersion for injection<br>COVID-19 mRNA Vaccine (nucleoside modified)<br>Pharmaceutical Form: Concentrate for solution for injection<br>INN or Proposed INN: Spikevax dispensation for injection<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br> | Timepoint(s) of evaluation of this end point: Week 48 after randomization;Primary end point(s): The primary outcome measure is neutralizing antibody levels specific to the Moderna or Pfizer vaccine at Week 48 after randomization.<br><br>Comparisons will be evaluated using the ratio of geometric mean responses. Antibody levels will be log10 transformed and summarized with stratified analysis of covariance.;Secondary Objective: 1 Estimate difference in NAb response to the Moderna vaccine or the Pfizer vaccine<br>2 Explore safety of the Moderna or the Pfizer vaccines in persons with prior COVID-19 who did or did not receive prior TICO-defined invest. agents<br>3 Explore whether the timing of vaccination and/or use of one or two doses affect the safety/tolerability<br>4 Estimate the percentage in each of the four vaccination groups with differences from baseline to Week 48<br>5 Compare the one and two-dose vaccination strategies for the percentage of participants who experience a composite outcome of death, SAE, grade 3, grade 4 AEs from vaccination<br>6 Compare the percentage of who experience death or an SAE through 24 weeks<br>7 Explore whether host characteristics, co-morbidities, co-medication, the course of prior COVID-19, type of vaccine, interval between enrolment in this protocol and baseline immune status affect humoral responses to SARS-CoV-2 vaccination and kinetics in NAb titers from 12 weeks after vaccination;Main Objective: 1. Among participants in TICO who were randomized to placebo, to estimate the difference in NAb levels at Week 48 to the Moderna mRNA-1273 vaccine or the Pfizer BNT162b2 vaccine among participants who are vaccinated early (i.e. at time of enrolment into this protocol, within 28 to 90 days of enrolment in TICO) versus deferred (i.e. 12 weeks after enrolment into this protocol).<br><br>2. Among participants in TICO who were randomized to placebo, to estimate the difference in neutralizing antibody levels at Week 48 to the Moderna mRNA-1273 vaccine or the Pfizer BNT162b2 vaccine among participants who are vaccinated once versus twice. | | | | Yes | False | | |
| → | EUCTR2021-003277-55-AT | 13 September 2021 | COVID-19 Antibody Responses in Cystic Fibrosis: CAR-CF | COVID-19 Antibody Responses in Cystic Fibrosis: CAR-CF - CAR-CF | | Medical University of Innsbruck, University Clinic for Pediatrics III | 27/07/2021 | 20210727 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-003277-55 | Not Available | No | | | <br>Female: yes<br>Male: yes<br> | | 5000 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>Other trial design description: prospective, longitudinal cohort study in pwCF with repeated serial sampling of participants<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| United States;European Union;Canada;Ireland;Austria;United Kingdom | Ass. Prof. Dr. Helmut Elemunter | | Anich Straße 35 | CFCI-Studies@i-med.ac.at | | Medical University of Innsbruck, Paediatrics Department, Cystic Fibrosis Center | Inclusion criteria: <br>Consenting people with CF (pwCF) of any age, genotype, transplant status and disease severity will be eligible to participate in the study. The study population is expected to be representative of the general CF population.<br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: 2450<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 2525<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 25<br> | Exclusion criteria: <br>There are no specific exclusion criteria other than refusal to give informed consent, or contraindication to venipuncture.<br> | COVID-19 vaccine Antibody response from natural infection or after vaccination in patients with Cystic Fibrosis (CF) <br>MedDRA version: 20.0
Level: LLT
Classification code 10021433
Term: Immunization
System Organ Class: 100000004865
<br>MedDRA version: 20.0
Level: PT
Classification code 10011762
Term: Cystic fibrosis
System Organ Class: 10010331 - Congenital, familial and genetic disorders
;Therapeutic area: Not possible to specify | <br>Trade Name: Comirnaty concentrate for dispersion for injection<br>COVID-19 mRNA Vaccine (nucleoside modified)<br>Product Name: Comirnaty<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: Tozinameran<br>CAS Number: 2417899-77-3<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br>Trade Name: Vaxzevria suspension for injection COVID-19 Vaccine (ChAdOx1-S<br>[recombinant])<br>Product Name: Vaxzevria<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recombinant])<br>Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)<br>Concentration unit: U unit(s)<br>Concentration type: not less then<br>Concentration number: 2.5 × 10^8 IFU-<br><br>Trade Name: COVID-19 Vaccine Moderna dispersion for injection<br>COVID-19 mRNA Vaccine (nucleoside modified)<br>Product Name: COVID-19 Vaccine Moderna<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: Elasomeran<br>CAS Number: 2430046-03-8<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br>Trade Name: COVID-19 Vaccine Janssen suspension for injection<br>COVID-19 vaccine (Ad26.COV2-S [recombinant])<br>Product Name: COVID-19 Vaccine Janssen suspension for injection COVID-19 vaccine (Ad26.COV2-S [recombinant])<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: COVID-19 vaccine (Ad26.COV2-S [recombinant])<br>Other descriptive name: Ad26.COV2-S.02<br>Concentration unit: U unit(s)<br>Concentration type: not less then<br>Concentration number: 8.92 log10 IFU-<br><br> | Timepoint(s) of evaluation of this end point: Analyses will be performed after 12 months and at the study end (24 months).<br>Blood samples will be collected at Day 0 (baseline), and Months 6, 12 and 24 post enrollment.;Primary end point(s): Potential endpoint(s) to include to investigate objective<br>• Proportion of pwCF with at least 1 seropositive result over the 2-year period<br>• Seroprevalence according to age group<br>• Seroprevalence according to geographical area<br>• Seroprevalence according to CF disease genotype and severity.<br>• Change in seroprevalence over time<br>• Risk factors for infection in pwCF<br>• Incidence of symptomatic COVID-19 over the 2 year study period and symptom severity <br>• Proportion of seropositive pwCF with subsequent CF exacerbations compared to pwCF who are seronegative <br>• Morbidity and mortality in pwCF with at least 1 seropositive result compared to pwCF who are seronegative<br>• Levels and duration of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2<br>• Analysis of these samples could include proteomic and genetic analysis and relating this to clinical outcome and antibody data collected as part of main study.<br>;Secondary Objective: n.a.;Main Objective: To evaluate the following objectives:<br>1. SARS-CoV-2 seroprevalence in an international CF cohort <br>2. Examine the associations between SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in people with CF<br>3. Longitudinal comparison of the development and progression of anti-SARS-CoV-2 antibodies in people with CF following natural infection and vaccination SARS-CoV-2<br>Optional study objective:<br>Storage of samples for future analysis on the impact of COVID-19 immune response in people with CF <br><br>→Main Objective: To evaluate the following objectives:<br>1. SARS-CoV-2 seroprevalence in an international CF cohort <br>2. Examine the associations between SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in people with CF<br>3. Longitudinal comparison of the development and progression of anti-SARS-CoV-2 antibodies in people with CF following natural infection and vaccination SARS-CoV-2<br>Optional study objective:<br>Storage of samples for future analysis on the impact of COVID-19 immune response in people with CF <br><br>;Secondary Objective: n.a.;Primary end point(s): Potential endpoint(s) to include to investigate objective<br>• Proportion of pwCF with at least 1 seropositive result over the 2-year period<br>• Seroprevalence according to age group<br>• Seroprevalence according to geographical area<br>• Seroprevalence according to CF disease genotype and severity.<br>• Change in seroprevalence over time<br>• Risk factors for infection in pwCF<br>• Incidence of symptomatic COVID-19 over the 2 year study period and symptom severity <br>• Proportion of seropositive pwCF with subsequent CF exacerbations compared to pwCF who are seronegative <br>• Morbidity and mortality in pwCF with at least 1 seropositive result compared to pwCF who are seronegative<br>• Levels and duration of anti-SARS-CoV-2 antibodies in pwCF following natural infection and vaccination SARS-CoV-2<br>• Analysis of these samples could include proteomic and genetic analysis and relating this to clinical outcome and antibody data collected as part of main study.<br>;Timepoint(s) of evaluation of this end point: Analyses will be performed after 12 months and at the study end (24 months).<br>Blood samples will be collected at Day 0 (baseline), and Months 6, 12 and 24 post enrollment. | | | | Yes | False | | |
| EUCTR2021-003573-58-BE | 13 September 2021 | Using one dose Pfizer to boost immunity after full vaccination with AstraZeneca in cancer patients | Vaccination against cOvid-19 In CancEr: booster shot BNT161b2 vaccine after full vaccination with ChAdOx1-S vaccine (Tri-VOICE plus) - Tri-VOICE plus | | Antwerp University Hospital | 16/07/2021 | 20210716 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-003573-58 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 09/08/2021 | 200 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Belgium | data manager | | Drie Eikenstraat 655 | lise.verbruggen@uza.be | | Antwerp University Hospital | Inclusion criteria: <br>• Patients with oncological or hematological malignancy<br>• Vaccinated with priming and boosting ChAd-0x1-S vaccine<br>• Ability to provide informed consent<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 100<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 100<br> | Exclusion criteria: <br>• Women who are pregnant or breastfeeding<br>• Immune deficiency not related to cancer or cancer treatment<br>• Allergy (multiple)<br><br><br> | Onco-hematological patients;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Trade Name: Comirnaty<br>Product Name: COMIRNATY<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: Comirnaty<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br> | Timepoint(s) of evaluation of this end point: day 28 after booster shot BNT162b2 vaccine;Primary end point(s): The first co-primary endpoint is the difference in SARS-CoV-2 IgG-RBD levels, after log-transformation to correct for the expected right-skewed distribution, before and 28 days after booster dose of COVID-19 mRNA vaccine BNT162b2 after 2 doses of ChAd-Ox1-S vaccine. <br><br>The second co-primary endpoint is the proportional increase (%) in the number of patients of the total cancer cohort who are categorized as high-responders between the day of receiving the booster shot BNT162b2 vaccine and 28 days thereafter. ;Secondary Objective: •To investigate the safety of the COVID-19 mRNA Vaccine BNT162b2 (Comirnaty®) booster shot<br>•To investigate the kinetics and longevity of the antibody response upon booster shot <br>•To investigate the proportion of high-responders per current treatment cohort 28 days after booster shot.<br>•To analyze the IgG titer of neutralizing antibodies, only in cases lower limit of quantification is exceeded, on 28 days and 6 months after booster shot<br>•Assessment of the cellular immune response <br>•Assessment of the SARS-Cov2 breakthrough infection rate <br>•Head-to-head comparison of the immune response day 28 after full vaccination (previous routine administration of priming and booster dose AstraZeneca) and day 28 after booster shot, i.e.a third dose being Comirnaty injection <br>;Main Objective: In the Tri-VOICE plus project, we want to offer a BNT161b2 vaccine booster shot as third dose with priority in a cohort of cancer patients being fully vaccinated with the ChAd-Ox1-S vaccine. In this way, we provide an answer to the high probability that these patients are left unprotected. On top of that, collecting knowledge about mixing vaccines and administering a booster shot is in line with the current clinical trials. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04362150 | 20 September 2021 | Long-term Impact of Infection With Novel Coronavirus (COVID-19) | Long-term Impact of Infection With Novel Coronavirus (LIINC): An Observational Study | LIINC | University of California, San Francisco | 23/04/2020 | 20200423 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04362150 | Recruiting | No | 18 Years | 100 Years | All | April 21, 2020 | 800 | Observational | | | United States | ; ; | Steven Deeks, MD;Rebecca Hoh, MS, RD;Steven G Deeks, MD | | ;rebecca.hoh@ucsf.edu;Steven.Deeks@ucsf.edu | ;415-476-4082;415-206-3103 | University of California, San Francisco; |
<br> Inclusion Criteria:
<br>
<br> 1. Willing and able to provide written informed consent, and
<br>
<br> 2. Age >/= 18 years, and
<br>
<br> 3. A history of SARS-CoV-2 infection, as evidenced by:
<br>
<br> 1. Available laboratory documentation of SARS-CoV-2 RNA positivity on a nucleic acid
<br> amplification test or by serologic testing when this becomes available, or
<br>
<br> 2. Reference by the participant to a laboratory test performed on respiratory tract
<br> secretions or blood, fingerstick, or saliva test that was reported to the
<br> participant to be positive for SARS-CoV-2 or COVID-19 infection,
<br>
<br> 4. And a period of 21 days or more has elapsed since the first positive test or symptoms
<br> preceding the first positive test, whichever is earlier.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Self-reported or documented chronic anemia with hemoglobin < 9 g/dL. Anemia during a
<br> preceding acute illness will not be exclusionary.
<br>
<br> 2. Serious medical or psychiatric illness that, in the opinion of the site investigator,
<br> would interfere with the ability to adhere to study requirements or to give informed
<br> consent.
<br>
<br> 3. Active drug or alcohol use or dependence that, in the opinion of the Principal
<br> Investigator, would interfere with adherence to study requirements or to give informed
<br> consent.
<br> | | COVID | | Proportion of participants previously hospitalized.;Participant race/ethnicity;Participant sex;Participant age | | | | Yes | False | | |
| → | NCT04365699 | 20 September 2021 | Cardiovascular Effects of COVID-19 | A Single-center Registry and Embedded Interventional Study of the Effects of COVID-19 With and Without Treatment With AT-001 on Cardiac Structure and Function in Patients Hospitalized for Management of COVID-19 Infection | | NYU Langone Health | 25/04/2020 | 20200425 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04365699 | Not recruiting | No | 18 Years | N/A | All | April 8, 2020 | 81 | Interventional | Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | | Stuart Katz, MD | | | | NYU Langone Health |
<br> Inclusion Criteria
<br>
<br> Registry Study: In order to be eligible to participate in the registry study, an individual
<br> must meet all of the following criteria:
<br>
<br> 1. Age =18 years of age
<br>
<br> 2. Hospitalized at one of the participating NYULH locations
<br>
<br> 3. Confirmed COVID-19 infection
<br>
<br> Interventional Study: In order to be eligible to participate in the registry study, and
<br> individual must meet all of the inclusion criteria of the registry study plus the following
<br> criteria:
<br>
<br> 1. Hospitalized at NYU Tisch
<br>
<br> 2. History of diabetes mellitus or blood glucose measurement >126 mg/dl AND EITHER
<br>
<br> 3. History of hypertension and/or ischemic heart disease and/or heart failure OR
<br>
<br> 4. Other co-morbid condition that in the opinion of the PI increases risk of heart or
<br> lung injury related to the aldose reductase pathway
<br>
<br> Exclusion Criteria
<br>
<br> Registry Study: An individual who meets any of the following criteria will be excluded from
<br> participation in the registry study:
<br>
<br> 1. Persons who have opted out of research participation at NYU
<br>
<br> 2. Pregnancy
<br>
<br> Interventional study: An individual who meets any of the following criteria will be
<br> excluded from participation in the interventional study:
<br>
<br> 1. Persons who have opted out of research participation at NYU
<br>
<br> 2. Pregnancy
<br>
<br> 3. Women of childbearing potential
<br>
<br> 4. Breast-feeding women
<br>
<br> 5. Participation in another investigational drug protocol within previous 30 days
<br> | | COVID-19 | Drug: AT-001 | Percentage of Participants Who Died;Hospital Length of Stay (LOS)→Hospital Length of Stay (LOS);Percentage of Participants Who Died | 16/09/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04365699 | Yes | False | | Yes |
| NCT04367077 | 20 September 2021 | MultiStem Administration for COVID-19 Induced ARDS (MACoVIA) | A Phase 2/3 Study to Assess the Safety and Efficacy of MultiStem® Therapy in Subjects With Acute Respiratory Distress Syndrome (ARDS) Due to Coronavirus Disease (COVID-19) | MACoVIA | Athersys, Inc | 27/04/2020 | 20200427 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04367077 | Recruiting | No | 18 Years | 89 Years | All | April 28, 2020 | 400 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States | ; | Eric Jenkins, MD;Athersys Clinical Trials Group | | ;macovia@athersys.com | ;2164263597 | Athersys, Inc; |
<br> Inclusion Criteria:
<br>
<br> Diagnosis of new acute-onset moderate to severe ARDS, as defined by the Berlin criteria,
<br> requiring an endotracheal or tracheal tube, Evidence of pneumonia or severe localized or
<br> systemic infection
<br>
<br> Exclusion Criteria:
<br>
<br> Moribund subject who, in the opinion of the Investigator, is not expected to survive at
<br> least 48 hours and End-stage severe chronic lung disease
<br> | | ARDS | Biological: MultiStem;Biological: Placebo | Ventilator-Free Days;Safety and Tolerability as measured by the incidence of treatment-emergent adverse events as assessed by CTCAE v5.0. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04529408 | 20 September 2021 | EARSATS-19: In-ear Measurement of Blood Oxygen Saturation in COVID-19 Follow up | EARSATS-19: In-ear Measurement of Blood Oxygen Saturation in COVID-19 Follow up | EARSATS-19 | Imperial College London | 26/08/2020 | 20200826 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04529408 | Recruiting | No | 18 Years | N/A | All | August 26, 2020 | 60 | Observational | | | United Kingdom | ; ; | Nicholas Peters, MD;Patrik Bachtiger, MBBS;Patrik Bachtiger | | ;p.bachtiger@imperial.ac.uk;p.bachtiger@imperial.ac.uk | ;07814396281;07814396281 | Imperial College London; |
<br> Inclusion Criteria:
<br>
<br> - Patients attending respiratory clinic either for COVID-19 follow up or for chronic
<br> lung disease.
<br>
<br> - Able to give informed consent (where not able to use CIE, paper consent form will be
<br> made available)
<br>
<br> Exclusion Criteria:
<br>
<br> - Abnormal ear canal anatomy
<br> | | Covid19;Pulmonary Disease | Device: EarSats Pulse Oximeter Probe | In-Ear vs finger SpO2 | | | | Yes | False | | |
| → | NCT04546841 | 20 September 2021 | Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults | P-pVAC-SARS-CoV-2: Phase I Single-center Safety and Immunogenicity Trial of Multi-peptide Vaccination to Prevent COVID-19 Infection in Adults | pVAC | University Hospital Tuebingen | 26/08/2020 | 20200826 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04546841 | Not recruiting | No | 18 Years | N/A | All | November 27, 2020 | 36 | Interventional | Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1 | Germany | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Adult male or non-pregnant, non-lactating female
<br>
<br> 1. Part I: Age 18-55 at the time of screening 2. Part II: Age 56-74 years at the time of
<br> screening 3. Part III: Age = 75 years at the time of screening 2. Pre-existing medical
<br> condition
<br>
<br> 1. Part I and II: Free of clinically significant health problems, as determined by
<br> pertinent medical history and clinical examination at study screening 3. Ability to
<br> understand and voluntarily sign the informed consent form. 4. Ability to adhere to the
<br> study visit schedule and other protocol requirements.
<br>
<br> 5. female with child bearing potential (FCBP) and male volunteers with partners of
<br> childbearing potential, who are sexually active must agree to the use of two effective
<br> forms (at least one highly effective method) of contraception. This should be started from
<br> the signing of the informed consent and continue until three months after vaccination 6.
<br> Postmenopausal or evidence of non-childbearing status. For women of childbearing potential:
<br> negative urine or serum pregnancy test within 7 days prior to study treatment.
<br> Postmenopausal or evidence of non-childbearing status is defined as:
<br>
<br> - Amenorrhoea for 1 year or more following cessation of exogenous hormonal treatments
<br>
<br> - Luteinizing hormone (LH) and Follicle stimulating hormone (FSH) levels in the post
<br> menopausal range for women under 50 7. Be willing to minimize blood and body fluid
<br> exposure of others for 7 days after vaccination
<br>
<br> - Use of effective barrier prophylaxis, such as latex condoms, during sexual intercourse
<br>
<br> - Avoiding the sharing of needles, razors, or toothbrushes
<br>
<br> - Avoiding open-mouth kissing
<br>
<br> - Refrain from blood donation during the course of the study
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnant or lactating females.
<br>
<br> 2. Participation in any clinical study with intake of any investigational drug
<br> interfering with the study primary endpoint
<br>
<br> 3. Any concomitant disease affecting the effect of the therapeutic vaccine or interfering
<br> with the study primary endpoint
<br>
<br> 4. Any immunosuppressive treatment except low dose corticosteroids (=10mg
<br> prednisolone/day)
<br>
<br> 5. Prior or current infection with SARS-CoV-2 tested serologically or by throat/nose swab
<br> (PCR)
<br>
<br> 6. History of Guillain-Barré Syndrome
<br>
<br> 7. Positive serological HIV, hepatitis B or C test. In case of positive HBsAg, volunteer
<br> must provide prove of hepatitis B vaccination, otherwise volunteer must be excluded.
<br>
<br> 8. History of relevant central nervous system (CNS) pathology or current relevant CNS
<br> pathology (e.g. seizure, paresis, aphasia, cerebrovascular ischemia/hemorrhage, severe
<br> brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain
<br> syndrome, psychosis, coordination or movement disorder, excluding febrile seizures as
<br> child)
<br>
<br> 9. Baseline laboratory with lymphocyte count = 1000/µl
<br>
<br> 10. Only Part I and II:
<br>
<br> - Acute or chronic, clinically significant psychiatric, hematologic, pulmonary,
<br> cardiovascular, or hepatic or renal functional abnormality as determined by the
<br> Investigator based on medical history, physical exam, and/or laboratory screening test
<br>
<br> 11. All parts of the clinical trial
<br>
<br> - Diabetes mellitus Typ II requiring drug treatment
<br>
<br> - Chronic lung disease requiring drug treatment
<br>
<br> - Any chronic liver disease or unknown liver abnormalities defined as:
<br>
<br> - Alanin-aminotransferase (ALT) and Aspartat-aminotransferase (AST) = 2.5 x
<br> ULN (upper limit of normal)
<br>
<br> - Gamma-glutamyl-transferase (?-GT) = 2.5 x ULN
<br>
<br> - Chronic renal failure defined as glomerular filtration rate (GFR) < 40
<br> ml/min/1,73m2
<br>
<br> - Serious pre-existing cardiovascular disease such as New York Heart Association
<br> (NYHA) = II, coronary heart disease requiring coronary surgery or known
<br> peripheral arterial disease (pAVK) = grade 2
<br>
<br> - Sickle cell anemia
<br>
<br> - Obesity (body mass index = 30kg/m2)
<br>
<br> 12. Hospitalization at study inclusion
<br>
<br> 13. Administration of immunoglobulins and/or any blood products within 120 days preceding
<br> study entry or planned administration during the study period
<br>
<br> 14. History of blood donation within 30 days of enrolment or planned donations within the
<br> study period
<br>
<br> 15. Known hypersensitivity to any of the components included in the CoVac-1 vaccine
<br> | | COVID-19 Vaccine | Biological: multipeptide cocktail | Safety- Eastern Cooperative Oncology Group (ECOG) Status;Safety -Vital Signs 2;Safety -Vital Signs 3;Safety-Blood Chemistry and Coagulation 1;Safety-Blood Chemistry and Coagulation 2;Safety-Hematology 1;Safety-Hematology 2;Safety-Hematology 3;Safety-Hematology 4→Safety-Hematology 4;Safety-Hematology 3;Safety-Hematology 2;Safety-Hematology 1;Safety-Blood Chemistry and Coagulation 2;Safety-Blood Chemistry and Coagulation 1;Safety -Vital Signs 3;Safety -Vital Signs 2;Safety- Eastern Cooperative Oncology Group (ECOG) Status | | | | Yes | False | | |
| NCT04549636 | 20 September 2021 | COVID-19 Related Lung Ventilation and Perfusion Injury | Prospective Longitudinal Study to Characterize and Understand the Clinical Relevance of SARS-CoV2 Related Ventilation and Perfusion Injury Evaluated by V/Q SPECT-CT in an Asthmatic and Healthy Population | | McMaster University | 28/08/2020 | 20200828 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04549636 | Recruiting | No | 18 Years | N/A | All | October 18, 2020 | 92 | Observational | | | Canada | ; ; | Sarah Svenningsen, PhD;Sarah Svenningsen, PhD;Sarah Svenningsen, PhD | | ;svennins@mcmaster.ca;svennins@mcmaster.ca | ;+1 (905) 522-1155;1 (905) 522-1155 | McMaster University; |
<br> Inclusion Criteria:
<br>
<br> For all participants:
<br>
<br> - Males and females = 18 years of age
<br>
<br> - Individuals able and willing to provide written informed consent
<br>
<br> - Individuals able and willing to comply with the study protocol
<br>
<br> For participants with asthma:
<br>
<br> - Individuals with physician confirmed asthma (12% bronchodilator reversibility or PC20
<br> methacholine less than 8mg/ml)
<br>
<br> - Individuals treated with inhaled corticosteroids, oral corticosteroids and/or anti-T2
<br> biologics
<br>
<br> For participants who recently recovered from covid-19:
<br>
<br> - Individuals previously diagnosed with covid-19 confirmed by FLOQswab test
<br>
<br> - Individuals who recently (=4-weeks) recovered from covid-19
<br>
<br> Exclusion Criteria:
<br>
<br> For all participants:
<br>
<br> - Males and females < 18 years of age
<br>
<br> - Individuals who are unable to read and/or understand English
<br>
<br> - Individuals who are pregnant or breastfeeding
<br>
<br> - Individuals who currently smoke or are an ex-smoker with =10 pack-year smoking history
<br>
<br> - Individuals who in the opinion of the investigator, are mentally or legally
<br> incapacitated, preventing informed consent from being obtained
<br>
<br> - Individuals who are unable to complete one or more study manoeuvres
<br>
<br> For participants with no history of lung disease:
<br>
<br> - Individuals with a history of respiratory infection or disease
<br>
<br> For participants who have not been diagnosed with covid-19:
<br>
<br> - Individuals who have previously had covid-19 confirmed by FLOQswab test
<br> | | Covid-19;Asthma;Healthy | Other: V/Q SPECT-CT;Other: St. George's Respiratory Questionnaire (SGRQ);Other: mMRC (Modified Medical Research Council) Dyspnea Scale;Other: Six-minute walk test (6MWT);Other: Spirometry;Other: Plethysmography & DLCO;Other: Airwave Oscillometry | Short-term difference in ventilation defect percent assessed by ventilation SPECT-CT - healthy;Short-term difference in perfusion defect percent assessed by perfusion SPECT-CT - healthy;Short-term difference in lung ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy;Long-term difference in ventilation defect percent assessed by ventilation SPECT-CT - healthy;Long-term difference in perfusion defect percent assessed by perfusion SPECT-CT - healthy;Long-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy;Short-term difference in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic;Short-term difference in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic;Short-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic;Long-term difference in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic;Long-term difference in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic;Long-term difference in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic;Longitudinal change in ventilation defect percent assessed by ventilation SPECT-CT - healthy;Longitudinal change in perfusion defect percent assessed by perfusion SPECT-CT - healthy;Longitudinal change in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - healthy;Longitudinal change in ventilation/perfusion mismatch assessed by ventilation/perfusion SPECT-CT - asthmatic;Longitudinal change in perfusion defect percent assessed by perfusion SPECT-CT - asthmatic;Longitudinal change in ventilation defect percent assessed by ventilation SPECT-CT - asthmatic | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04878822 | 20 September 2021 | Immunogenicity of Covid-19 Vaccination for Patients With Hematological Malignancies | Prospective, Cohort, Non-interventional, Single-center Clinical Study of Immune Response Status to SARS-CoV-2 / Covid-19 Vaccination in Patients With Haematological Malignancies. | | Ospedale di Circolo - Fondazione Macchi | 04/05/2021 | 20210504 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04878822 | Not recruiting | No | 18 Years | N/A | All | April 13, 2021 | 300 | Observational | | | Italy | | Francesco Passamonti, MD | | | | Ospedale di Circolo e Fondazione Macchi, ASST Sette Laghi, Varese, Italy |
<br> Inclusion Criteria:
<br>
<br> - Age = 18 years.
<br>
<br> - History of hematological neoplasia (myeloid neoplasms, lymphoid neoplasms, plasma cell
<br> dyscrasias).
<br>
<br> - Active hematological neoplasm.
<br>
<br> Exclusion Criteria:
<br>
<br> - Hematological diseases, other than hematological malignancies.
<br> | | Immunogenicity;Hematological Malignancies;Covid-19;Vaccine Response Impaired | | To evaluate the humoral immune response to SARS-CoV-2 / Covid-19 vaccination. | | | | Yes | False | | |
| → | NCT04887350 | 20 September 2021 | SSIPP vs. PST vs. WLC | Naturalistic Pilot Study Comparing the Feasibility of Applying a Student Senior Isolation Prevention Partnership vs. Problem-solving Therapy vs. Waitlist Control in Patients Suffering From Late-life Depression During the COVID-19 Pandemic: A Randomized Controlled Trial | | Lawson Health Research Institute | 05/05/2021 | 20210505 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04887350 | Recruiting | No | 65 Years | N/A | All | August 9, 2021 | 45 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | Canada | ; ; | Akshya Vasudev, MD;Akshya Vasudev, MD;Akshya Vasudev, MD | | ;akshya.vasudev@lhsc.on.ca;akshya.vasudev@lhsc.on.ca | ;519-685-8500;519-685-8500 | London Health Sciences Centre; |
<br> Inclusion Criteria:
<br>
<br> 1. Community-dwelling senior 65 years of age or older.
<br>
<br> 2. Meeting criteria of suffering from an episode of major depression, mild to moderate,
<br> as assessed by an experienced psychiatrist (DSM 296.21, 296.22, 296.31, 296.32), with
<br> the following applicable specifiers including anxious distress, mixed features,
<br> melancholic features, atypical features and seasonal pattern
<br>
<br> 3. Willing to receive services via telephone.
<br>
<br> 4. Have sufficient hearing to converse via telephone.
<br>
<br> 5. Have an adequate understanding of written and spoken English.
<br>
<br> 6. Answer yes to the question "do you perceive that you are either lonely or isolated?"
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pre-existing dementia or other neurodegenerative disorder as confirmed by a Montreal
<br> Cognitive Assessment (MoCA) score, telephone version, 17 or below
<br>
<br> 2. History of schizophrenia
<br>
<br> 3. History of bipolar disorder
<br>
<br> 4. History of substance use disorder
<br>
<br> 5. History of personality disorder as per previous clinical documentation
<br>
<br> 6. History of suicide attempts or threats as per previous clinical documentation or
<br> endorsement of any of the questions from item 2-6 of the Columbia- Suicide Severity
<br> Rating Scale.
<br> | | Major Depressive Disorder;Late Life Depression | Behavioral: Student-Senior Isolation Prevention Partnership (SSIPP);Behavioral: Problem Solving Therapy (PST). | Unexpected costs;Cost of interventions;Completeness of data entry;Rate of retention;Rate of participant recruitment→Rate of participant recruitment;Rate of retention;Completeness of data entry;Cost of interventions;Unexpected costs | | | | Yes | False | | |
| NCT04888949 | 20 September 2021 | A Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection (COVID-19) | An Phase2 Study of ADR-001 in Patients With Severe Pneumonia Caused by SARS-CoV-2 Infection | | Rohto Pharmaceutical Co., Ltd. | 09/05/2021 | 20210509 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04888949 | Recruiting | No | 20 Years | N/A | All | June 15, 2021 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | Japan | ; ; | Okawa Sumito;Rohto Pharmaceutical Co., Ltd.;Yuji Fujino, MD | | ;adr-001@rohto.co.jp;adr-001@rohto.co.jp | ;+81-3-6823-6014;+81-3-6823-6014 | Rohto Pharmaceutical Co., Ltd.; |
<br> Inclusion Criteria:
<br>
<br> - SARS-CoV-2 infection is confirmed on antigen test or PCR test
<br>
<br> - Pulmonary infiltrative shadow is confirmed on chest X-ray test
<br>
<br> - PaO2/FiO2 <=200mmHg at the time of screening
<br>
<br> Exclusion Criteria:
<br>
<br> - Continue treatment for Pneumonia before SARS-CoV-2 infection
<br>
<br> - SOFA score >= 15
<br>
<br> - Infection type on DIC diagnosis criteria >= 4
<br>
<br> - Deep Venous Thrombosis
<br> | | SARS-CoV-2 Infection( COVID-19 ) | Biological: Mesenchymal stem cell;Biological: Placebo | Ventilator Free Days | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05008003 | 20 September 2021 | Dietary Supplements Vit D, Quercetin and Curcumin Combination for Early Symptoms of COVID-19 | Clinical Trial to Investigate the Benefits of Adjuvant Treatment of Combination of Dietary Supplements Curcumin, Quercetin, and Vitamin D for Early Symptoms for COVID-19 Infection | | Ayub Teaching Hospital | 11/08/2021 | 20210811 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05008003 | Recruiting | No | 18 Years | N/A | All | September 5, 2021 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Pakistan | ; | Dr. Zeeshan Haroon, MBBS;Dr. Zeeshan Haroon, MBBS | | zeeshanharoon@yahoo.com;zeeshanharoon@yahoo.com | + 92 317 5564317;+ 92 317 5564317 | |
<br> Inclusion Criteria:
<br>
<br> - Patients must be 18 years of age or older, of either gender
<br>
<br> - Patients must be tested positive for SARS-CoV-2 by RT-PCR
<br>
<br> - Patients must exhibit typical symptoms of COVID-19 disease at screening such as fever,
<br> fatigue, a dry and contagious cough, loss of appetite, body aches, shortness of
<br> breath, mucus or phlegm, sore throat, headache, chills, sometimes withshaking, loss of
<br> smell or taste, congestion or runny nose, nausea, or vomiting, diarrhea, muscular pain
<br> etc.
<br>
<br> - Patients must be in the early stage of COVID-19 disease who do not require
<br> hospitalization at the time of screening
<br>
<br> - Patients must be under the care of a Physician for diagnosis of COVID-19
<br>
<br> - Patients who have signed informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients with proven hypersensitivity or allergic reaction to quercetin or curcumin
<br>
<br> - Patients with known chronic kidney disease with estimated creatinine clearance < 50
<br> mL/minute or need for dialysis
<br>
<br> - Patients who are severely hypotensive defined as needing hemodynamic pressors to
<br> maintain blood pressure
<br>
<br> - Patients taking anticoagulant/antiplatelet drugs such as Coumarine, Heparine, Aspirin,
<br> Clopidrogel, dalteparin, enoxaparin, ticlopidine and warparin.
<br>
<br> - Patients with gallstone obstruction
<br>
<br> - Hypothyroid suppering patients
<br>
<br> - Patients with moderate or severe thrombocytopenia (platelet count <100 ×10?/L);
<br>
<br> - Pregnant patients
<br> | | Covid19 | Drug: Standard of care;Dietary Supplement: combination of curcumin, quercetin and Vitamin D | COVID-19 symptoms improvement;SARS-CoV-2 Negativity by RT-PCR | | | | Yes | False | | |
| → | NCT05011513 | 20 September 2021 | A Study of PF-07321332/Ritonavir in Non-hospitalized Low-Risk Adult Participants With COVID-19 | AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2 ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF 07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT LOW RISK OF PROGRESSING TO SEVERE ILLNESS | | Pfizer | 30/07/2021 | 20210730 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05011513 | Recruiting | No | 18 Years | N/A | All | August 25, 2021 | 1140 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States;Argentina;Brazil;Colombia;Hungary;Japan;Korea, Republic of;Malaysia;Puerto Rico;Spain;Taiwan;Thailand;Turkey;Argentina;Brazil;Colombia;Hungary;Japan;Korea, Republic of;United States;Turkey;Thailand;Taiwan;Spain;Puerto Rico;Malaysia→United States;Argentina;Brazil;Colombia;Hungary;Japan;Korea, Republic of;Malaysia;Puerto Rico;Spain;Taiwan;Thailand;Turkey;Argentina;Brazil;Colombia;Hungary;Japan;Korea, Republic of;Malaysia;Puerto Rico;Spain;Taiwan;Thailand;Turkey;United States | ; | Pfizer CT.gov Call Center;Pfizer CT.gov Call Center | | ;ClinicalTrials.gov_Inquiries@pfizer.com | ;1-800-718-1021 | Pfizer; |
<br> Inclusion Criteria:
<br>
<br> - Confirmed SARS-CoV-2 infection 5 days prior to randomization
<br>
<br> - Initial onset of COVID-19 signs/symptoms within 5 days of randomization
<br>
<br> - Fertile participants must agree to use a highly effective method of contraception
<br>
<br> Exclusion Criteria:
<br>
<br> - Has received or is expected to receive any COVID-19 vaccine, except for participants
<br> with an underlying medical condition associated with an increased risk of developing
<br> severe illness from COVID-19. Participants with these conditions who are fully
<br> vaccinated are considered to be at lower risk of developing severe disease and are
<br> therefore considered eligible.
<br>
<br> - History of or need for hospitalization for the medical treatment of COVID-19.
<br>
<br> - Prior diagnosis of SARS-CoV-2 infection (reinfection)
<br>
<br> - Known medical history of liver disease
<br>
<br> - Receiving dialysis or have known renal impairment
<br>
<br> - Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml or
<br> taking prohibited medications for HIV treatment
<br>
<br> - Suspected or confirmed concurrent active systemic infection other than COVID-19
<br>
<br> - Current or expected use of any medications or substances that are highly dependent on
<br> Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
<br>
<br> - Has received or is expected to receive monoclonal antibody treatment or convalescent
<br> COVID-19 plasma
<br>
<br> - Is expected to receive a SARS-CoV-2 vaccine between screening and the study Day 34
<br> visit
<br>
<br> - Participating in another interventional clinical study with an investigational
<br> compound or device, including those for COVID-19
<br>
<br> - Known prior participation in this trial or other trial involving PF-07321332
<br>
<br> - Oxygen saturation of < 92% on room air
<br>
<br> - Females who are pregnant or breastfeeding
<br> | | COVID-19 | Drug: PF-07321332;Drug: Ritonavir;Drug: Placebo;Drug: Placebo | Time to Sustained Alleviation of All Targeted COVID-19 Signs/Symptoms | | | | Yes | False | | |
| NCT05017805 | 20 September 2021 | COVID-19 Vaccines in Patients With Chronic Liver Disease | Safety and Immunogenicity of COVID-19 Vaccines in Patients With Chronic Liver Disease: A Multi-center Prospective Study | | Beijing 302 Hospital | 12/08/2021 | 20210812 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05017805 | Recruiting | No | 18 Years | N/A | All | August 15, 2021 | 300 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | China | | Fu-Sheng Wang, MD | | fswang302@163.com | 01066933328 | |
<br> Inclusion Criteria:
<br>
<br> - Age = 18 years.
<br>
<br> - Serum ALT and AST are both = 80 U/L.
<br>
<br> - HIV and TPHA screening were negative.
<br>
<br> - Body temperature =37.0?.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who confirmed the diagnosis of liver cancer by imaging examination (CT/MRI/B
<br> scan).
<br>
<br> - Patients who are allergic to any component of the vaccine, or have a serious history
<br> of vaccine allergy.
<br>
<br> - Women who is pregnant, breastfeeding, or planning to be pregnant within 6 months.
<br>
<br> - Patients with cardiovascular diseases, such as arrhythmia, conduction block,
<br> myocardial infarction, and severe hypertension can not be well controlled by drugs.
<br>
<br> - Patients with severe chronic diseases or diseases can not be controlled well during
<br> the progress, such as asthma, diabetes, thyroid disease, etc. Congenital or acquired
<br> angioedema / neuroedema.c.
<br>
<br> - Patients with urticaria within a year.
<br>
<br> - Patients with coagulation disorder.
<br>
<br> - Faintng during acupuncture treatment .
<br>
<br> - Patients who received other investigational drugs within one month.
<br>
<br> - Be receiving anti-TB treatment.
<br>
<br> - Other conditions determined by the researcher.
<br> | | Liver Disease Chronic | Biological: COVID-19 Vaccines | Immunogenicity of coronavirus vaccine;Safety of coronavirus vaccine | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04311177 | 27 September 2021 | Losartan for Patients With COVID-19 Not Requiring Hospitalization | Randomized Controlled Trial of Losartan for Patients With COVID-19 Not Requiring Hospitalization | | University of Minnesota | 13/03/2020 | 20200313 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04311177 | Not recruiting | No | 18 Years | N/A | All | April 9, 2020 | 162 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | United States | ; | Christopher Tignanelli, MD;Michael Puskarich, MD, MS | | ; | ; | University of Minnesota;University of Minnesota |
<br> Inclusion Criteria:
<br>
<br> - Positive laboratory test for COVID-19 based on local laboratory standard
<br>
<br> - Age greater than or equal to 18 years of age
<br>
<br> - One of the following: Upper respiratory symptoms (cough, rhinorrhea) or fever (>101.5)
<br> or loss of taste / smell
<br>
<br> Exclusion Criteria:
<br>
<br> - Randomization > 72 hours of meeting inclusion criteria
<br>
<br> - Randomization > 7 days of symptom onset
<br>
<br> - Currently taking an angiotensin converting enzyme inhibitor (ACEi) or Angiotensin
<br> receptor blocker (ARB)
<br>
<br> - Prior reaction or intolerance to an ARB or ACE inhibitor, including but not limited to
<br> angioedema
<br>
<br> - Pregnant or breastfeeding women
<br>
<br> - Females able to have children not currently taking a protocol allowed version of
<br> contraception: intrauterine device, Depo-formulation of hormonal contraception (e.g.
<br> medroxyprogesterone acetate/Depo-Provera), subcutaneous contraceptive (e.g.
<br> Nexplanon), daily oral contraceptives with verbalized commitment to taking daily
<br> throughout the study, condom use or abstinence during the study. All participants of
<br> child bearing potential enrolled in this fashion will be informed of the teratogenic
<br> risks.
<br>
<br> - Patient reported history or electronic medical record history of kidney disease,
<br> defined as:
<br>
<br> 1. Any history of dialysis
<br>
<br> 2. History of chronic kidney disease stage IV
<br>
<br> 3. Estimated Glomerular Filtration Rate (eGFR) of < 30ml/min/1.73 m2 (must be have
<br> been measured within 1 month of enrollment)
<br>
<br> 4. Other kidney disease that in the opinion of the investigator, would affect
<br> losartan clearance
<br>
<br> - Patient reported dehydration and significantly decreased urine output in the past 72
<br> hours
<br>
<br> - Most recent systolic blood pressure prior to enrollment <110 mmHg
<br>
<br> - Patient reported history or electronic medical record history of severe liver disease,
<br> defined as:
<br>
<br> 1. Cirrhosis
<br>
<br> 2. History of hepatitis B or C
<br>
<br> 3. Other liver disease that in the opinion of the investigator, would affect
<br> losartan clearance
<br>
<br> 4. Documented AST or ALT > 3 times the upper limit of normal within 3 months of
<br> randomization (if available in electronic medical record)
<br>
<br> - Potassium >5.0 mmol/L (must have been measured within 1 month) of enrollment
<br>
<br> - Concurrent treatment with aliskiren
<br>
<br> - Inability to obtain informed consent
<br>
<br> - Enrollment in another blinded randomized clinical trial for COVID
<br> | | Corona Virus Infection;Acute Respiratory Distress Syndrome;SARS-CoV Infection | Drug: Losartan;Other: Placebo | Hospital Admission | | | | Yes | False | | |
| → | NCT04315298 | 27 September 2021 | Evaluation of the Efficacy and Safety of Sarilumab in Hospitalized Patients With COVID-19 | An Adaptive Phase 2/3, Randomized, Double-Blind, Placebo-Controlled Study Assessing Efficacy and Safety of Sarilumab for Hospitalized Patients With COVID-19 | | Regeneron Pharmaceuticals | 15/03/2020 | 20200315 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04315298 | Not recruiting | No | 18 Years | N/A | All | March 18, 2020 | 1912 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States | | Clinical Trial Management | | | | Regeneron Pharmaceuticals |
<br> Key Inclusion Criteria:
<br>
<br> - Laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction
<br> (PCR), result from any specimen (or other commercial or public health assay) within 2
<br> weeks prior to randomization and no alternative explanation for current clinical
<br> condition
<br>
<br> - Hospitalized with illness of any duration with evidence of pneumonia, requires
<br> supplemental oxygen and/or assisted ventilation and meets one of the following:
<br>
<br> - Phase 2 and Phase 3 Cohort 1:
<br>
<br> Meets 1 of the following criteria at baseline:
<br>
<br> - Severe disease OR
<br>
<br> - Critical disease OR
<br>
<br> - Multi-system organ dysfunction OR
<br>
<br> - Immunocompromised
<br>
<br> - Phase 3 Cohort 2:
<br>
<br> Patients must be receiving mechanical ventilation to treat respiratory failure due to
<br> COVID-19
<br>
<br> - Phase 3 Cohort 3:
<br>
<br> Patients must be receiving supplemental oxygen to treat hypoxemia delivered by one of the
<br> following devices:
<br>
<br> - Non-rebreather mask, OR
<br>
<br> - High-flow device with at least 50% FiO2, OR
<br>
<br> - Non-invasive positive pressure ventilator
<br>
<br> - Ability to provide informed consent signed by study patient or legally acceptable
<br> representative
<br>
<br> - Willingness and ability to comply with study-related procedures/assessments
<br>
<br> Key Exclusion Criteria:
<br>
<br> - In the opinion of the investigator, not expected to survive for more than 48 hours
<br> from screening
<br>
<br> - Presence of any of the following abnormal laboratory values at screening: absolute
<br> neutrophil count (ANC) less than 2000 mm3, aspartate aminotransferase (AST) or alanine
<br> aminotransferase (ALT) > 5 x upper limit of normal (ULN), platelets <50,000 per mm3
<br>
<br> - Treatment with anti-IL 6, anti-IL-6R antagonists, or with Janus kinase inhibitors
<br> (JAKi) in the past 30 days or plans to receive during the study period
<br>
<br> - Current treatment with the simultaneous combination of leflunomide and methotrexate
<br>
<br> - Known active tuberculosis (TB), history of incompletely treated TB, suspected or known
<br> extrapulmonary TB, suspected or known systemic bacterial or fungal infections
<br>
<br> - Participation in a double-blind clinical research study evaluating an investigational
<br> product (IP) or therapy within 3 months and less than 5 half-lives of IP prior to the
<br> screening visit (The use of remdesivir, hydroxychloroquine, or other treatments being
<br> used for COVID-19 treatments in the context of an open-label study, Emergency Use
<br> Authorization (EUA), compassionate use protocol or open-label use is permitted)
<br>
<br> - Any physical examination findings, and/or history of any illness, concomitant
<br> medications or recent live vaccines that, in the opinion of the study investigator,
<br> might confound the results of the study or pose an additional risk to the patient by
<br> their participation in the study
<br>
<br> - Known systemic hypersensitivity to sarilumab or the excipients of the drug product
<br>
<br> - Phase 3 Cohort 2 and Cohort 3 only:
<br>
<br> - Known or suspected history of immunosuppression or immunodeficiency disorder
<br>
<br> - Patients who require renal replacement therapy for acute kidney injury at
<br> randomization or who required renal replacement therapy within 72 hours prior to
<br> randomization
<br>
<br> - Patients who have circulatory shock requiring vasopressors at randomization or within
<br> 24 hours prior to randomization
<br>
<br> - Use of extracorporeal life support (eg, ECMO) or, in the opinion of the investigator,
<br> there is a high likelihood that extracorporeal life support will be initiated within
<br> 48 hours after randomization
<br>
<br> NOTE: Other protocol defined inclusion / exclusion criteria may apply
<br> | | COVID-19 | Drug: Sarilumab;Drug: Placebo | Percent Change From Baseline in CRP Levels at Day 4 in Participants With Serum IL-6 Level Greater Than the ULN (Phase 2);Percentage of Participants With at Least a 1-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale in Participants With Critical COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 1);Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 2)→Percentage of Participants With at Least 1-point Improvement in Clinical Status Using the 7-point Ordinal Scale in Participants With COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 2);Percentage of Participants With at Least a 1-point Improvement in Clinical Status From Baseline to Day 22 Using the 7-point Ordinal Scale in Participants With Critical COVID-19 Receiving Mechanical Ventilation at Baseline (Phase 3 Cohort 1);Percent Change From Baseline in CRP Levels at Day 4 in Participants With Serum IL-6 Level Greater Than the ULN (Phase 2) | 23/09/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04315298 | Yes | False | | Yes |
| NCT04320862 | 27 September 2021 | COVID-19 Pandemic Response Network | Pandemic Response Network: Duke Community Health Watch | | Duke University | 23/03/2020 | 20200323 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04320862 | Not recruiting | No | N/A | N/A | All | April 3, 2020 | 9207 | Observational | | | United States | | Becky Smith, MD | | | | Duke University |
<br> Inclusion Criteria:
<br>
<br> - flu-like symptoms
<br>
<br> - a viral test order for COVID-19
<br>
<br> - confirmed COVID-19
<br>
<br> - concern for exposure to COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> - None
<br> | | COVID-19;SARS-CoV-2;Coronavirus;Influenza -Like Illness;Lower Resp Tract Infection;Upper Resp Tract Infection | | Number of participants who experience inpatient admission | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04497272 | 27 September 2021 | Assesment of the Metabolomic Signature in COVID-19 Patients | Assesment of the Metabolomic Signature in COVID-19 Patients (SignCov Study) | SignCov | Centre Hospitalier Universitaire de Nice | 03/08/2020 | 20200803 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04497272 | Not recruiting | No | 18 Years | N/A | All | August 7, 2020 | 150 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | France | | OCCELLI Céline | | | | Néphrologie, CHU de Nice |
<br> Inclusion Criteria:
<br>
<br> - patient over 18 years of age
<br>
<br> - affiliated to a social security scheme
<br>
<br> - consultant in the emergency department and/or being hospitalized for suspected SARS
<br> CoV infection
<br>
<br> - confirmation, after medical examination, of the need for a biological examination
<br> (this will negate the need for additional venipuncture)
<br>
<br> Exclusion criteria:
<br>
<br> - Patient who do not meet inclusion criteria
<br>
<br> - Person subject to a guardianship order
<br>
<br> - Opposition to the use of the data or samples (withdrawal of non-opposition) /
<br> Sponsor's or investigator's decision
<br> | | COVID 19 | Other: COVID-19 patients | Identifying the metabolomic signature | | | | Yes | False | | |
| → | NCT04501445 | 27 September 2021 | Psychological Symptoms and Families of COVID-19 Patients | Relieving the Burden of Psychological Symptoms Among Families of Critically Ill Patients With COVID-19 | | Rush University Medical Center | 04/08/2020 | 20200804 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04501445 | Not recruiting | No | 18 Years | N/A | All | September 14, 2020 | 90 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - The patient's surrogate was enrolled in "ICU Rounding Summaries for Families of
<br> Critically Ill Patients" (NCT03969810) and the patient had COVID-19
<br>
<br> - The patient has been discharged from the hospital
<br>
<br> Exclusion Criteria:
<br>
<br> - None
<br> | | Family Members;Post Intensive Care Unit Syndrome;Post Traumatic Stress Disorder | Behavioral: Written Summary of Rounds | Symptoms of Post-Traumatic Stress Disorder (PTSD) initial;Symptoms of Anxiety and Depression initial→Symptoms of Anxiety and Depression initial;Symptoms of Post-Traumatic Stress Disorder (PTSD) initial | | | | Yes | False | | |
| NCT04501822 | 27 September 2021 | One-year Cardiac Follow-up of Patients With COVID-19 Pneumonia | One-year Cardiac Follow-up of Patients With COVID-19 Pneumonia | | Tomsk National Research Medical Center of the Russian Academy of Sciences | 28/07/2020 | 20200728 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04501822 | Not recruiting | No | 18 Years | N/A | All | July 19, 2020 | 380 | Observational | | | Russian Federation | | Elena Yaroslavskaya, PhD | | | | Tyumen Cardiology Research Center |
<br> Inclusion Criteria:
<br>
<br> -Patients with documented COVID-19 pneumonia
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients with cancer
<br>
<br> - Impossible to follow up
<br> | | Covid19;Cardiac Complication | Diagnostic Test: Evaluation of clinical, instrumental and laboratory diagnostics tests | Echocardiographic assessment of cardiac function | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04757883 | 27 September 2021 | Immunological Follow-up After SARS CoV2 Vaccination in Kidney Transplant Recipients | Immunological Follow-up After COVID 19 Vaccination in Kidney Transplant Recipients | COVATRHUS | University Hospital, Strasbourg, France | 11/02/2021 | 20210211 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04757883 | Recruiting | No | 18 Years | N/A | All | February 2, 2021 | 100 | Observational | | | France | ; | Sophie Caillard, MD;Sophie Caillard | | sophie.caillard@chru-strasboourg.fr; | 003388116768; | |
<br> Inclusion Criteria:
<br>
<br> - Male or female, 18 years of age or older
<br>
<br> - Patient vaccinated against SARS-CoV-2 as part of routine care
<br>
<br> - Kidney or pancreatic kidney transplant
<br>
<br> - Transplantation for more than 3 months
<br>
<br> - Subject affiliated to a social protection health insurance
<br>
<br> - Subject able to understand the objectives and risks of the research and to give signed
<br> and dated informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - History of anaphylactic shock or known allergy to PEG
<br>
<br> - Known history of COVID or positive Covid serology in the 3 months prior to vaccination
<br>
<br> - Contraindication to an intramuscular injection
<br>
<br> - Impossibility to give informed information about the subject (subject in an emergency
<br> situation, difficulties in understanding the subject, ...)
<br>
<br> - Subject under safeguard of justice
<br>
<br> - Subject under guardianship
<br> | | Kidney Transplant Recipients | Other: Study of the synthesis of antibodies directed against SARS | The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.;The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.;The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.;The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine.;The primary endpoint will be the rate of kidney transplant patients with neutralizing Antibodies directed against the Spike protein of the SARS CoV-2 virus after the 2nd injection of the vaccine. | | | | Yes | False | | |
| → | NCT04784767 | 27 September 2021 | SARS-COV-2-Spike-Ferritin-Nanoparticle (SpFN) Vaccine With ALFQ Adjuvant for Prevention of COVID-19 in Healthy Adults | A PHASE 1, Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Ranging Doses of SARS-COV-2-Spike-Ferritin-Nanoparticle (SPFN_1B-06-PL) Vaccine With Army Liposomal Formulation QS21 (ALFQ) for Prevention of COVID-19 in Healthy Adults. | | U.S. Army Medical Research and Development Command | 03/03/2021 | 20210303 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04784767 | Not recruiting | No | 18 Years | 55 Years | All | April 5, 2021 | 29 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1 | United States | | Paul Scott, M.D., MPH | | | | Walter Reed Army Institute of Research (WRAIR) |
<br> Inclusion Criteria:
<br>
<br> - Must be a male or non-pregnant, non-breastfeeding female between the ages of 18 and 55
<br> years, inclusive, at the time of enrollment.
<br>
<br> - Must be willing and able to read, sign, and date the informed consent document.
<br>
<br> - Must demonstrate an understanding of the study with a passing score (90% or greater)
<br> on the Test of Understanding (TOU) by the third attempt, before study-related
<br> procedures are performed.
<br>
<br> - Must be willing and able to comply with study requirements and be available for
<br> follow-up visits for the entire study.
<br>
<br> - Must have the means to be contacted by telephone and/or video for remote follow-up
<br> visits as needed.
<br>
<br> - Must have a body mass index (BMI) =18.1 kg/m2 and <35.0 kg/m2.
<br>
<br> - Have no previously documented COVID-19/SARS-CoV-2 infection
<br>
<br> - Must agree to refrain from donating blood or plasma outside of this study for the
<br> duration of participation in this study.
<br>
<br> - Must have acceptable screening laboratory findings: white blood cell (WBC),
<br> hemoglobin, platelet count, prothrombin (PT), prothrombin time (PTT), aspartate
<br> transaminase (AST), alanine transaminase (ALT), alkaline phosphatase (ALP),
<br> creatinine, and total bilirubin) within 14 days before Study Day 1.
<br>
<br> - Must be healthy based on the physician investigator's clinical judgment after review
<br> of past medical history, medication use, vital signs, and an abbreviated physical
<br> examination.
<br>
<br> - Biological females must have a negative urine pregnancy test at screening and a
<br> negative urine pregnancy test immediately before each study injection.
<br>
<br> - Biological females of reproductive capacity must use an acceptable method of
<br> contraception, beginning 30 days before enrollment, and until at least 60 days after
<br> the last study injection.
<br>
<br> Exclusion Criteria:
<br>
<br> - Has plans to become pregnant or is currently pregnant or breastfeeding.
<br>
<br> - Seropositive to COVID-19 by binding antibody titer assay.
<br>
<br> - Confirmed positive for active infection of human immunodeficiency virus (HIV),
<br> hepatitis C virus (HCV), or presence of Hepatitis B surface antigen (HbsAg).
<br>
<br> - Has known or suspected congenital or acquired immunodeficiency, or recent history or
<br> current use of immunosuppressive therapy.
<br>
<br> - History of organ and or stem cell transplantation.
<br>
<br> - Has a history of malignancy other than squamous cell or basal cell skin cancer, unless
<br> there has been surgical excision that is considered to have achieved a cure.
<br>
<br> - Has diabetes mellitus type 1 or type 2 (including cases controlled with diet alone)
<br> and/or thyroid disease.
<br>
<br> - Has major psychiatric illness during the last 12 months that, in the physician
<br> investigator's opinion, would preclude participation.
<br>
<br> - Has a history of other chronic diseases or conditions
<br>
<br> - Has a current or history of substance abuse that, in the physician investigator's
<br> opinion, would preclude participation.
<br>
<br> - Has tattoos, scars, or other marks that would, in the opinion of the physician
<br> investigator, interfere with the assessment of the injection site.
<br>
<br> - Has a known allergy or history of anaphylaxis or other serious reaction to a vaccine,
<br> vaccine component, or latex.
<br>
<br> - Had major surgery (per the physician investigator's judgment) in the month before
<br> screening or has plans to have major surgery during the study.
<br>
<br> - Received blood products or immunoglobulin in the three months before screening or has
<br> plans to use during the study.
<br>
<br> - Donated a unit of blood within eight weeks before Study Day 1 or has plans to donate
<br> blood during the study.
<br>
<br> - Received an experimental COVID-19 vaccine outside of this study or a COVID-19 vaccine
<br> that has been given Emergency Use Authorization from the FDA
<br>
<br> - Received live attenuated vaccine from 30 days before Study Day 1 until 30 days after
<br> the last study injection.
<br>
<br> - Received killed or inactivated vaccine from 14 days before Study Day 1 and until 30
<br> days after the last study injection.
<br>
<br> - Received experimental therapeutic agents within three months before the first study
<br> injection or has plans to receive any experimental therapeutic agents during the
<br> entire course of the study.
<br>
<br> - Concurrent participation in another study requiring blood draws or exposure to
<br> investigational or non-investigational vaccine/product (pharmaceutical or device)
<br> throughout the study period.
<br>
<br> - Has an acute illness or temperature =38.0 degrees Celsius (C)/100.4 degrees Fahrenheit
<br> (F) on any study injection day or within 48 hours of planned study injection.
<br>
<br> - In the physician investigator's opinion, is unable to communicate reliably, is
<br> unlikely to adhere to study requirements, or has a condition that would limit
<br> completion of the study.
<br>
<br> - Is unwilling to have their samples collected and stored for future research.
<br>
<br> - Emergency medical services personnel and healthcare provider with patient contact in
<br> potentially high risk/high exposure settings as per screening physician's assessment.
<br>
<br> - Current smoker or inhales vaporized nicotine "Vaping" daily. Current smoker is defined
<br> as an adult who has smoked 100 cigarettes in his or her lifetime and who currently
<br> smokes cigarettes.
<br> | | SARS-CoV-2 Infection | Biological: 25 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant);Drug: Sodium chloride, USP, for injection (0.9% NaCl);Biological: 50 µg SpFN_1B-06-PL + ALFQ (QS21 Adjuvant) | Number of participants with humoral immune response at Study Day 43 (+/- 2).;Incidents of treatment-adverse events as assessed by FDA Toxicity grading scale.;Number of participants with local and systemic reactions→Number of participants with local and systemic reactions;Incidents of treatment-adverse events as assessed by FDA Toxicity grading scale.;Number of participants with humoral immune response at Study Day 43 (+/- 2). | | | | Yes | False | | |
| NCT04813796 | 27 September 2021 | A Study to Evaluate Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 Vaccines in Healthy Adults Between 18 Years and 55 Years of Age to Prevent COVID-19 | A Phase 1, Randomized, Observer-Blind, Dose-Ranging Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1283 and mRNA-1273 SARS-CoV-2 Vaccine in Adults Aged 18-55 Years | | ModernaTX, Inc. | 22/03/2021 | 20210322 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04813796 | Not recruiting | No | 18 Years | 55 Years | All | March 11, 2021 | 106 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1 | United States | | | | | | |
<br> Key Inclusion Criteria:
<br>
<br> - Understands and agrees to comply with the study procedures and provides written
<br> informed consent.
<br>
<br> - According to the assessment of the investigator, is in good general health and can
<br> comply with study procedures.
<br>
<br> - Body mass index (BMI) of 18 kilograms/square meter (kg/m^2) to 35 kg/m^2 (inclusive)
<br> at the Screening Visit (Day 0).
<br>
<br> - For female participants of childbearing potential: negative pregnancy test, adequate
<br> contraception or has abstained from all activities that could result in pregnancy for
<br> at least 28 days prior to the first injection, agreement to continue adequate
<br> contraception or abstinence through 3 months following the second injection, and not
<br> currently breastfeeding.
<br>
<br> Key Exclusion Criteria:
<br>
<br> - Known history of SARS-CoV-2 infection or known exposure to someone with SARS-CoV-2
<br> infection or COVID-19 in the past 30 days.
<br>
<br> - Positive serology results for SARS-CoV-2 at the Screening Visit. A negative
<br> serological test for SARS-CoV-2, performed on a blood sample obtained at the Screening
<br> Visit, is required before a participant can be dosed.
<br>
<br> - Travel outside of the United States in the 28 days prior to the Screening Visit (Day
<br> 0).
<br>
<br> - Prior administration of an investigational, authorized, or licensed CoV (for example,
<br> SARS-CoV-2, SARS-CoV, or Middle East Respiratory Syndrome [MERS]-CoV) vaccine, based
<br> on medical history interview.
<br>
<br> - Current treatment with investigational agents for prophylaxis against COVID-19.
<br>
<br> - Recent (within the last 12 months) use of a dermal filler.
<br>
<br> - Has a medical, psychiatric, or occupational condition that may pose additional risk as
<br> a result of participation or that could interfere with safety assessments or
<br> interpretation of results according to the investigator's judgment.
<br>
<br> - Has received systemic immunosuppressants or immune-modifying drugs for >14 days in
<br> total within 6 months prior to Screening (for corticosteroids, 10 milligrams (mg)/day
<br> of prednisone equivalent) or is anticipating the need for immunosuppressive treatment
<br> at any time during participation in the study.
<br>
<br> - Has received or plans to receive any licensed vaccine 28 days prior to the first
<br> injection (Day 1) or plans to receive a licensed vaccine within 28 days before or
<br> after any study injection, with the exception of licensed influenza vaccines, which
<br> may be received more than 14 days before the first study injection or more than 14
<br> days after the second study injection.
<br>
<br> - Receipt of systemic immunoglobulins or blood products within 3 months prior to the
<br> Screening Visit (Day 0) or plans for receipt during the study.
<br>
<br> - Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine
<br> vapors).
<br>
<br> - History of chronic smoking (1 cigarette a day) within 1 year of the Screening Visit.
<br>
<br> - Resides in a nursing home.
<br>
<br> - Has donated 450 milliliters (mL) of blood products within 28 days prior to the
<br> Screening Visit or plans to donate blood products during the study.
<br>
<br> - Participated in an interventional clinical study within 28 days prior to the Screening
<br> Visit based on the medical history interview or plans to do so while participating in
<br> this study.
<br> | | SARS-CoV-2 | Biological: mRNA-1283;Biological: mRNA-1273;Biological: Placebo | Number of Participants with Medically-Attended AEs (MAAEs), AE of Special Interest (AESIs), and Serious Adverse Events (SAEs);Number of Participants with Unsolicited Adverse Events (AEs);Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs) | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05046769 | 27 September 2021 | COVID-19: A Scope Research on Epidemiology and Clinical Course | COVID-19: A Scope Research on Epidemiology and Clinical Course | COVID-Scope | Instituto de Saude Publica da Universidade do Porto | 05/09/2021 | 20210905 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05046769 | Recruiting | No | N/A | N/A | All | April 28, 2020 | 5000 | Observational | | | Portugal | ; ; | Margarida Tavares, MD, MPH;Margarida Tavares, MD, MPH;Margarida Tavares | | ;mftavares@ispup.up.pt;margarida.tavares@chsj.min-saude.pt | ;+351222061820;+351225512389 | Centro Hospitalar Universitário São João & ISPUP; |
<br> Inclusion Criteria:
<br>
<br> - Individuals diagnosed with SARS-2-CoV-2 infection treated at CHUSJ and cohabitants
<br> able to give informed consent;
<br>
<br> - individuals who underwent the test for diagnosis of infection by SARS-CoV-2 at CHUSJ
<br> with negative result able to give informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Inability to obtain informed consent;
<br> | | Covid19;SARS CoV 2 Infection;Sequelae of; Infection | | Clinical, biological, psychosocial characteristics | | | | No | False | | |
| → | NCT05047666 | 27 September 2021 | COVID-Like Illness Respiratory Pathogens. A Prospective Cohort on the COVID-19 Post-acute Condition | CLEAR: COVID-Like Illness Respiratory Pathogens - Diagnostics Response in Ghana. A Prospective Cohort on the COVID-19 Post-acute Condition | CLEAR | Bernhard Nocht Institute for Tropical Medicine | 14/09/2021 | 20210914 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05047666 | Not recruiting | No | 16 Years | N/A | All | October 2021 | 1232 | Observational | | | | ; ; ; ; | Ricardo Strauss, Dr.MD. MPH;Jürgen May, Prof. Dr.;Oumou Maiga-Ascofare, PhD;John Amuasi, MBChB, MPH, PhD;Ricardo Strauss, Dr. MD. MPH | | ;;;;ricardo.strauss@bnitm.de | ;;;;+49 40 42818 243 | Bernhard Nocht Institute for Tropical Medicine;Bernhard Nocht Institute for Tropical Medicine;Kumasi Center for Collaborative Research in Tropical Medicine;Kumasi Center for Collaborative Research in Tropical Medicine; |
<br> 1. For symptomatic patients attending to the SFXH or other satellite health centers
<br>
<br> - Inclusion Criteria
<br>
<br> 1. Patients > or =16 years of age
<br>
<br> 2. Presenting respiratory symptoms
<br>
<br> 3. Positive respiratory sample for SARS-CoV-2 or other respiratory infections
<br> included in the panel
<br>
<br> 4. Possibility to be contacted during follow-up
<br>
<br> 5. Consented participation
<br>
<br> 6. Patients which households are located within the study catchment area
<br>
<br> - Exclusion Criteria
<br>
<br> 1. Symptomatic patients who test negative for all pathogens of the PCR-based
<br> respiratory panel.
<br>
<br> 2. Symptomatic patients who test negative for the SARS-CoV-2 RDT and do not
<br> meet the matching criteria (age and residency (community)) as symptomatic
<br> controls to any of the recruited cases (to be considered as controls for the
<br> Antimicrobial Use Workpackage)
<br>
<br> 2. Antimicrobial Use Work package (A subset of hospitalized, symptomatic patients are to
<br> be recruited as control group for the Antimicrobial Use Workpackage, if they meet the
<br> inclusion criteria)
<br>
<br> - Inclusion Criteria
<br>
<br> 1. Patients > or =16 years of age
<br>
<br> 2. Presenting respiratory symptoms
<br>
<br> 3. Negative respiratory sample for SARS-CoV-2 (RDT)
<br>
<br> 4. Do not meet the matching criteria (age and residency (community)) as
<br> symptomatic controls to any of the recruited cases
<br>
<br> 5. Admitted to SFXH
<br>
<br> 6. Consented participation
<br>
<br> 3. For healthy controls from the community
<br>
<br> - Inclusion Criteria
<br>
<br> 1. Patients > or =16 years of age
<br>
<br> 2. Meet the age and residency (community) criteria to be matched to the cases
<br>
<br> 3. Possibility to be contacted during follow-up
<br>
<br> 4. Consented participation
<br>
<br> - Exclusion Criteria
<br>
<br> 1. Presenting COVID-19 like symptoms
<br>
<br> 2. Positive for SARS-CoV-2 RDT Eligible participants in the community
<br> presenting with an acute illness can be considered for inclusion as a case
<br> and recommended for referral to SFXH/ satellite health centre.
<br> | | Respiratory Infection;COVID-19 Respiratory Infection;Sequelae of; Infection | | Admissions and Outpatient encounter;Persistent or new symptoms;Medication and therapy→Medication and therapy;Persistent or new symptoms;Admissions and Outpatient encounter | | | | Yes | False | | |
| NCT05047692 | 27 September 2021 | Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers | A Dose Escalation, Multicenter, Open, Phase I Study to Assess the Safety and Immunogenicity of AdCLD-CoV19-1, a COVID-19 Preventive Vaccine in Healthy Volunteers. | | Cellid Co., Ltd. | 14/09/2021 | 20210914 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05047692 | Recruiting | No | 19 Years | 64 Years | All | September 9, 2021 | 40 | Interventional | Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1 | Korea, Republic of | ; | Gaeun Park, M.S;Gaeun Park, M.S | | gepark@cellid.co.kr;gepark@cellid.co.kr | +82-3285-7863; | |
<br> Inclusion Criteria:
<br>
<br> - Able and willing to agree informed consent and aged 19 to 64 years.
<br>
<br> - The BMI index is 18.5 kg/m2 to 30.0 kg/m2.
<br>
<br> - Able and willing to medically effective contraception during the whole study period.
<br>
<br> - Agreement to refrain from blood donation during the whole study period.
<br>
<br> Exclusion Criteria:
<br>
<br> - Anyone deemed infected by COVID-19.
<br>
<br> - Determined to be a close-contact of SARS-CoV-2 confirmed case or classified to
<br> symptomatic patient of COVID-19 prior to vaccination.
<br>
<br> - Clinically significant abnormal ranges of laboratory measurement, ECG, Chest X-ray at
<br> screening visit.
<br>
<br> - Positive in HIV, HBV, HCV test at screening visit.
<br>
<br> - Acute fever(= 38?) or suspected infectious disease, symptoms of infectious
<br> disease(cough, difficulty breathing, chills, muscle aches, headache, sore throat, loss
<br> of smell, or loss of taste, etc.) within 3 days prior to vaccination.
<br>
<br> - Chronic respiratory disease: Asthma, chronic obstructive pulmonary disease, active
<br> tuberculosis, latent tuberculosis under treatment.
<br>
<br> - Clinically significant active or any history of disease: Hepatobiliary system, kidney,
<br> central or peripheral nervous system (epilepsy, seizure, etc.), endocrine system
<br> (uncontrolled diabetes, hyperlipidemia, etc.), cardiovascular system (congestive heart
<br> failure, coronary artery disease, myocardial infarction, control Hypertension, etc.),
<br> blood tumor, urinary system, mental, musculoskeletal system, immune system (rheumatoid
<br> arthritis, systemic lupus erythematosus).
<br>
<br> - Immunosuppressive disease including immunodeficiency disease.
<br>
<br> - Scheduled to undergo any surgery during the whole study period.
<br>
<br> - Healthcare worker who provide medical care to SARS-CoV-2 cases or occupationally in
<br> high risk for SARS-CoV-2 exposure during the whole study period.
<br>
<br> - Prisoners or subjects who are compulsorily detained. (involuntary incarceration)
<br>
<br> - History of SARS or MERS.
<br>
<br> - Allergic reaction or hypersensitivity to any ingredient of AdCLD-CoV19-1.
<br>
<br> - Having hemophilia at risk of causing serious bleeding when injected intramuscularly or
<br> receiving anticoagulants.
<br>
<br> - Any history of malignant disease within the past 5 years. History of hypersensitivity
<br> to inoculate vaccine such as Guillain-Barre syndrome.
<br>
<br> - History of serious adverse reaction or allergic reaction to inoculate vaccine.
<br>
<br> - Urticaria past 5 years prior to vaccination.
<br>
<br> - History of hereditary angioneurotic edema or acquired angioneurotic edema.
<br>
<br> - History of solid organ or bone marrow transplantation.
<br>
<br> - Suspected or a history of drug or alcohol abuse past 12 month before vaccination.
<br>
<br> - Receipt of vaccine of SARS-CoV, MERS-CoV, SARS-CoV-2.
<br>
<br> - Receipt of adenovirus vector based vaccine.
<br>
<br> - Chronic use of immunosuppressant or immune modifying drug within 6 months prior to
<br> vaccination. (use of inhaled, topical, nasal, and ophthalmic corticosteroids are
<br> allowed)
<br>
<br> - Having relied on antipsychotic drugs and narcotic analgesics within 6 months before
<br> vaccination or difficult to comply with the clinical trial procedure at the judgment
<br> of the investigator.
<br>
<br> - Administered to other investigational product or medical device within 6 months before
<br> vaccination.
<br>
<br> - Other vaccination history within 30 days prior to vaccination or being scheduled
<br> within 30 days after vaccination.
<br>
<br> - Receipt of immunoglobulin or any blood product within 3 month prior to vaccination.
<br>
<br> - Pregnant(including positive hCG test at screening visit) or breastfeeding female.
<br>
<br> - Those who are directly related to the investigator.
<br>
<br> - Other condition deemed ineligible for the study at the discretion of investigator.
<br> | | Covid19 | Biological: AdCLD-CoV19-1 | Incidence of solicited adverse events(AEs);Incidence of unsolicited AEs | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05048940 | 27 September 2021 | Efficacy, Safety, and Immunogenicity of Vaccine Reimmunization With a Third Homologous Versus Heterologous Dose Against SARS-CoV-2 in Patients Undergoing Solid Organ Transplantation. | Randomized, Open-label, Adaptive, Controlled, Phase III Clinical Trial to Evaluate the Efficacy, Safety and Immunogenicity of Reimmunization With Third Dose of Homologous vs. Heterologous Vaccine Against COVID-19 in Patients Undergoing Solid Organ Transplantation: Liver, Heart, Kidney and Lung. | REIN-TX | Instituto de Investigación Marqués de Valdecilla | 08/09/2021 | 20210908 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05048940 | Not recruiting | No | 18 Years | N/A | All | September 2021 | 386 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 3 | Spain | ; ; | Javier Crespo García;Marcos López Hoyos;María del Mar García Saiz | | ;;mmar.garcia@scsalud.es | ;;942 20 33 33 | Hospital Universitario Marqués de Valdecilla;Hospital Universitario Marqués de Valdecilla; |
<br> Inclusion Criteria:
<br>
<br> 1. Patients who underwent solid organ transplantation prior to revaccination against
<br> COVID-19.
<br>
<br> 2. Patients who have received the full COVID-19 vaccination regimen with Spikevax
<br> (Moderna) vaccine, with a minimum of 8 weeks having elapsed from the second dose to
<br> the time of trial initiation.
<br>
<br> 3. Age > 18 years.
<br>
<br> 4. All participants must have previously agreed to participate in the study by signing
<br> the informed consent form.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Having suffered SARS-CoV-2 infection at any time prior to inclusion in the study.
<br>
<br> 2. Subjects without solid organ transplantation or with a different solid organ (e.g.
<br> pancreas transplantation) and without any type of immunosuppression (immunocompetent
<br> non-transplanted) from the general population.
<br>
<br> 3. Age < 18 years
<br>
<br> 4. Temperature of at least 38°C in the 24 hours prior to immunization or other clinically
<br> relevant acute symptomatology.
<br>
<br> 5. Clinical manifestations compatible with COVID-19 infection at the time of
<br> evaccination.
<br>
<br> 6. Known allergy or history of anaphylaxis or other serious adverse events to the
<br> administration of vaccines or their excipients.
<br>
<br> 7. Any other condition that contraindicates vaccination against SARSCov2, including
<br> pregnancy.
<br>
<br> 8. Having presented graft rejection in the 15 days prior to the start of the study.
<br>
<br> 9. Any condition or situation that may interfere with the ability to maintain adherence
<br> to study procedures and visits.
<br> | | Covid19 | Biological: Janssen vaccine;Biological: Spikevax (Moderna) vaccine | Changes in the production of anti-S1-RBD IgG antibodies. | | | | Yes | False | | |
| → | NCT05049226 | 27 September 2021 | Third Dose Vaccination With AstraZeneca or Pfizer COVID-19 Vaccine Among Adults Received Sinovac COVID-19 Vaccine | A Randomized, Observer-blind Trial to Assess the Immunogenicity and Safety of Third Dose Vaccination With AstraZeneca COVID-19 (ChAdOx1 AZD1222) Vaccine or Pfizer/BioNTech COVID-19 (BNT162b2) Vaccine Among Thai Adults Who Have Received Two Doses of Sinovac Inactivated COVID-19 Vaccine | | Mahidol University | 14/09/2021 | 20210914 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05049226 | Not recruiting | No | 18 Years | 59 Years | All | September 2021 | 1320 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 2 | | ; ; ; ; ; ; ; ; | Punnee Pitisuttithum, MD;Atibordee Meesing, MD;Romanee Chaiwarith, MD,MHS;Sarunyou Chusri, MD,PhD;Sira Nanthapisal, MD,PhD;Suppachok Kirdlarp, MD;Suvimol Niyomnaitham, MD,PhD;Sarawut Siwamogsatham, MD;Punnee Pitisuttithum, M.D. | | ;;;;;;;;punnee.pit@mahidol.ac.th | ;;;;;;;;081-829 4906 | Vaccine Trial Centre, Faculty of Tropical Medicine, Mahidol University;Faculty of Medicine, Khon Kaen University;Faculty of Medicine, Chiang Mai University;Faculty of Medicine, Prince of Songkla University;Faculty of Medicine, Thammasat University;Chakri Naruebodindra Medical Institute, Faculty of Medicine Ramathibodi hospital,Mahidol University;Mahidol University;Chulalongkorn University; |
<br> Inclusion Criteria:
<br>
<br> 1. Adult male or female age equal or more than 20 years with Thai ID cards
<br>
<br> 2. Received two doses (21-28 days apart) of Sinovac inactivated COVID-19 vaccine who will
<br> be divided according to their intervals 60-less than 90 days, 90-less than120 days and
<br> 120-180 days
<br>
<br> 3. Has provided written informed consent prior to performance of any study-specific
<br> procedure
<br>
<br> 4. No history of fever or PUI symptoms within 7 days
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Any confirmed or suspected immunosuppressive or immunodeficient state.
<br>
<br> 2. Contraindication to AZ or PF according to labelling of the products
<br>
<br> 3. History of COVID infection within 3 months period
<br>
<br> 4. Pregnancy
<br> | | COVID-19 Infection;COVID-19 VACCINE | Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) full dose;Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) full dose;Biological: AstraZeneca ChAdOx1 AZD1222 vaccine (AZ) half dose;Biological: Pfizer/BioNTech BNT162b2 vaccine (PF) half dose | GMT Anti-S IgG at baseline;GMT Anti-S IgG at 28 days after vaccination;GMT Anti-S IgG at 60 days after vaccination;GMT Anti-S IgG at 90 days after vaccination;GMFR changed from baseline in anti-S IgG GMT at 28 days after vaccination;GMFR changed from baseline in anti-S IgG GMT at 60 days after vaccination;GMFR changed from baseline in anti-S IgG GMT at 90 days after vaccination;Anti-S IgG Seroresponses changed from baseline at 28 days after vaccination;Anti-S IgG Seroresponses changed from baseline at 60 days after vaccination;Anti-S IgG Seroresponses changed from baseline at 90 days after vaccination;GMT against SARS-Cov-2 pseudovirus (PVNT) Neutralizing antibody titer 50 at baseline;GMT against SARS-Cov-2 pseudovirus (PVNT) Neutralizing antibody titer 50 at 28 days after vaccination;GMT against SARS-Cov-2 pseudovirus (PVNT) Neutralizing antibody titer 50 at 90 days after vaccination;GMFR changed from baseline in NT50 against SARS-CoV-2 pseudovirus at 28 days after vaccination;GMFR changed from baseline in NT50 against SARS-CoV-2 pseudovirus at 90 days after vaccination;NT50 seroresponses against SARS-CoV-2 pseudovirus changed from baseline at 28 days after vaccination;NT50 seroresponses against SARS-CoV-2 pseudovirus changed from baseline at 90 days after vaccination;Frequency of solicited reportable local adverse event after vaccination;Frequency of solicited reportable systemic adverse event after vaccination;Frequency of all unsolicited AEs;Frequency of SAEs→Frequency of SAEs;Frequency of all unsolicited AEs;Frequency of solicited reportable systemic adverse event after vaccination;Frequency of solicited reportable local adverse event after vaccination;NT50 seroresponses against SARS-CoV-2 pseudovirus changed from baseline at 90 days after vaccination;NT50 seroresponses against SARS-CoV-2 pseudovirus changed from baseline at 28 days after vaccination;GMFR changed from baseline in NT50 against SARS-CoV-2 pseudovirus at 90 days after vaccination;GMFR changed from baseline in NT50 against SARS-CoV-2 pseudovirus at 28 days after vaccination;GMT against SARS-Cov-2 pseudovirus (PVNT) Neutralizing antibody titer 50 at 90 days after vaccination;GMT against SARS-Cov-2 pseudovirus (PVNT) Neutralizing antibody titer 50 at 28 days after vaccination;GMT against SARS-Cov-2 pseudovirus (PVNT) Neutralizing antibody titer 50 at baseline;Anti-S IgG Seroresponses changed from baseline at 90 days after vaccination;Anti-S IgG Seroresponses changed from baseline at 60 days after vaccination;Anti-S IgG Seroresponses changed from baseline at 28 days after vaccination;GMFR changed from baseline in anti-S IgG GMT at 90 days after vaccination;GMFR changed from baseline in anti-S IgG GMT at 60 days after vaccination;GMFR changed from baseline in anti-S IgG GMT at 28 days after vaccination;GMT Anti-S IgG at 90 days after vaccination;GMT Anti-S IgG at 60 days after vaccination;GMT Anti-S IgG at 28 days after vaccination;GMT Anti-S IgG at baseline | | | | Yes | False | | |
| NCT05050201 | 27 September 2021 | Implementation of Digital CBT for Insomnia in First Episode Psychosis | Implementation of a Digital Cognitive Behavioural Therapy Intervention for Insomnia in First Episode Psychosis in the Context of Covid19: A Mixed Methods Study | | NHS Greater Glasgow and Clyde | 05/08/2021 | 20210805 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05050201 | Recruiting | No | 16 Years | 35 Years | All | April 20, 2021 | 22 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United Kingdom | ; | Andrew Gumley;Elaine O'Neill - Senior Research Administrator | | ;Elaine.O'Neill2@ggc.scot.nhs.uk | ;0141 314 4011 | NHS Greater Glasgow and Clyde; University of Glasgow; |
<br> Inclusion Criteria:
<br>
<br> - Service users under the care of Esteem First Episode Psychosis Service in NHS GGC
<br>
<br> - Potentially affected by Insomnia Disorder (defined by Sleep Condition Indicator-02
<br> score =2)
<br>
<br> - Who have access to a device they can use Sleepio on (a computer device with Safari or
<br> Google Chrome browser, or an iPhone device).
<br>
<br> Exclusion Criteria:
<br>
<br> - Moderate to severe learning disability
<br>
<br> - Acute Psychosis (recent crisis contact or hospitalisation)
<br>
<br> - Incapacity to provide informed consent
<br>
<br> - Insufficient English to access intervention
<br>
<br> - Organic impairment
<br>
<br> - No access to a device which can be used for Sleepio intervention.
<br> | | Insomnia;Psychosis;First Episode Psychosis | Device: Sleepio | Qualitative data;Implementation data - completion of intervention sessions;Implementation data - completion of measures;Implementation data - eligibility;Implementation data - rates of consenting | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05052346 | 4 October 2021 | Association of the Neutrophil/Lymphocyte Ratio With Pulmonary Complications and Mortality in COVID-19 Patients | Association of the Neutrophil/Lymphocyte Ratio and Lymphocyte/Platelet Ratio With Pulmonary Complications and Mortality in COVID-19 Patients | | Hospital General de Mexico | 31/07/2020 | 20200731 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05052346 | Not recruiting | No | 18 Years | 80 Years | All | March 30, 2020 | 200 | Observational [Patient Registry] | | | Mexico | | Adolfo Martinez Tovar | | | | Hospital General de Mexico |
<br> Inclusion Criteria:
<br>
<br> - Patients with active COVID-19 infection
<br>
<br> Exclusion Criteria:
<br>
<br> - Liver failure
<br>
<br> - Active cancer
<br>
<br> - Chronic renal failure
<br>
<br> - AIDS
<br>
<br> - Pregnancy
<br> | | Covid19;Pulmonary Complication | | Respiratory Complications in COVID-19 patients;Mortality in COVID-19 patients | | | | Yes | False | | |
| → | NCT05054075 | 4 October 2021 | Protocol Design for Evaluating the Immunity of Bivalve Fluids From Anodonta Cygnea in SARS and COVID-19 | Methodological Design for Evaluating the Immune Capacity of Bivalve Fluids From Anodonta Cygnea in SARS and COVID-19 Human Infection: Intelligent Medicine Integration. | | Universidade do Porto | 03/08/2021 | 20210803 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05054075 | Not recruiting | No | 14 Years | N/A | All | October 2021 | 40 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | Portugal | ; | Jorge P Machado, PhD;Jorge P Machado, PhD | | ;jmachado@icbas.up.pt | ;+351917670878 | ICBAS - Instituto de Ciências Biomédicas Abel Salazar; |
<br> Inclusion Criteria:
<br>
<br> - Subjects with normal physiological state or any kind of comorbidity
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects in highly critical health state
<br> | | Coronavirus Infections;Coronavirus Sars-Associated;SARS (Severe Acute Respiratory Syndrome);COVID-19 | Biological: Marine liquid and fluids;Biological: Impregnation;Biological: Incubation;Biological: Manipulation;Biological: Refrigeration | Pulmonary system;Pulmonary system change;Pulmonary system change;Pulmonary system change;Pulmonary system change;Cardiac system;Cardiac system change;Cardiac system change;Cardiac system change;Cardiac system change;Immunologic system change;Immunologic system change;Immunologic system change;Immunologic system change;Immunologic system→Immunologic system change;Immunologic system change;Immunologic system change;Immunologic system change;Immunologic system;Cardiac system change;Cardiac system change;Cardiac system change;Cardiac system change;Cardiac system;Pulmonary system change;Pulmonary system change;Pulmonary system change;Pulmonary system change;Pulmonary system | | | | Yes | False | | |
| NCT05054101 | 4 October 2021 | Life With Covid Since 2020: a Randomized Control Trial of a Real-time Data Collection Smartphone-based App Assessing and Treating the Covid-19 Psychological Impacts | Life With Covid Since 2020: a Randomized Control Trial of a Real-time Data Collection Smartphone-based App Assessing and Treating the Covid-19 Psychological Impacts | VieCovid2020 | Assistance Publique - Hôpitaux de Paris | 22/09/2021 | 20210922 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05054101 | Not recruiting | No | 18 Years | N/A | All | December 15, 2021 | 850 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator). | N/A | | | Bruno MILLET, MD, PhD | | b.millet@aphp.fr | 1 42 16 28 09 | |
<br> Inclusion criteria :
<br>
<br> - PTSD or adjustment disorders criteria according to DSM-5 and MINI criteria within the
<br> context of COVID-19 trauma exposure and economic consequences;
<br>
<br> - patients with a PCL-5 score higher than 33;
<br>
<br> - patient treated or who will be treated by the following treatments: SSRIs alone or
<br> SSRIs in combination to CBTs, EMDR or reconsolidation blockade
<br>
<br> - able to download and use an app, with a correct internet connection (owner of a
<br> smartphone)
<br>
<br> - Affiliation to a French social security system (recipient or assign) excluding AME
<br>
<br> - written consent to participate in the study;
<br>
<br> Exclusion criteria :
<br>
<br> - age lower than 18, without any upper age limit;
<br>
<br> - suicidal risk using MINI;
<br>
<br> - non-French speaker;
<br>
<br> - guardianship curatorship and person deprived of their liberty by judicial decision
<br> | | PTSD | Other: Real-time assessment using the VieCovid2020 smartphone application | Superiority of the VieCovid2020 smartphone app | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| ISRCTN61736991 | 4 October 2021 | Survey of burnout among doctors specializing in anesthesiology in Brazil during the COVID-19 pandemic | Burnout among anesthesiology residents in Brazil during the COVID-19 pandemic - a cross-sectional survey | | Faculdade de Medicina do ABC | 21/09/2021 | 20210921 | ISRCTN | https://www.isrctn.com/ISRCTN61736991 | Not Recruiting | No | | | Both | 12/01/2021 | 84 | Observational | Nationwide observational cross-sectional study (Screening) | Not Applicable | Brazil | | | | | | | Inclusion criteria: 1. Anesthesiology residents in their 1st, 2nd, and 3rd year of training. | Exclusion criteria: 1. Refusal to sign the e-consent form | Burnout risk in anesthesiology residents <br>Not Applicable | <br> Participants will answer an online survey that takes less than 5 minutes to complete.<br><br> Participants will be stratified for burnout risk based on the Oldenburg Burnout Inventory (OLBI). An overall score above 4.73 will classify residents as being “at risk” of burnout, while scores beyond 2.33 for exhaustion and 2.40 for disengagement will classify residents as “high risk” for burnout. Participants’ individual and work-related factors will be analyzed by two logistic regressions, with the outcomes “at risk” and “high risk” for burnout. Significant results from those regressions will be included in a multiple linear regression model with the OLBI score as the outcome variable. Beta coefficients will be used to standardize the correlations and semi partial correlation will determine the percentage of correlation between each factor and the OLBI score. Beta coefficients above or equal to 0.2 will determine the strength of correlation as moderate to strong, while those below 0.2 as weaker correlations. If a question with adaptive options is significant, a sub-analysis will be conducted by multiple regression or correlation, as appropriate.<br> | Burnout risk measured using the Oldenburg Burnout Inventory at a single time point. | | 02/03/2021 | | No | False | | |
| → | ISRCTN18100261 | 4 October 2021 | Daily contact testing schools and colleges trial | A pragmatic cluster randomised trial in English secondary schools comparing the impact of a policy of weekly testing for COVID-19 followed by isolation of cases and their contacts, with a policy of weekly testing followed by isolation of cases and daily testing of contacts | | Department of Health and Social Care | 04/05/2021 | 20210504 | ISRCTN | https://www.isrctn.com/ISRCTN18100261 | Not Recruiting | No | | | Both | 22/03/2021 | 200000 | Interventional | Pragmatic cluster randomized controlled study (Prevention) | Not Applicable | United Kingdom;England→England;United Kingdom | Saroj | Kendrick | Department of Health and Social Care | Saroj.Kendrick@dhsc.gov.uk | +44 (0)7871 983 171 | | Inclusion criteria: <br> 1. Secondary school/further education college<br> 2. Willing and able to follow the study protocol<br> 3. Willing and able to undertake PCR testing of contacts in the event the school is allocated to the control group<br> 4. Commits to maintaining contact management in line with national standards<br> 5. Willing and able to provide regular data of test results to Test and Trace and to allow members of an index case’s contact group to be flagged in a database.<br> 6. Willing and able to support baseline data collection requirements (e.g., provision of school register, bubble allocation data, etc.)<br> 7. Willing to communicate regularly to Participants via Participant Information Sheets and other communication materials<br> 8. Willing and able to provide a dedicated DHSC-funded Research Assistant to support data collection<br><br> Inclusion criteria for DCT (in the intervention arm):<br> Staff (including temporary or contract staff) and students in secondary schools/further education colleges/year 7 and above in all-through schools’ individuals, who are:<br> 1. Contact of a positive case related to school<br> 2. Asymptomatic<br> 3. Onsite i.e. not self-isolating or shielding<br> 4. Contact of an index case in the school’s population i.e. a staff member or student who has tested positive<br> | Exclusion criteria: <br> 1. The school’s contact management policy does not conform to national standards<br> 2. Inability to support in-school LFD testing (i.e. not part of the NHS Test and Trace Asymptomatic Testing Site network)<br><br> Exclusion criteria for DCT (in the intervention arm):<br> 1. Contact of a non-school index case<br> 2. Household contact of a diagnosed COVID-19 positive individual<br> 3. Symptomatic individuals<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> Schools and colleges are stratified by size (<500 of =500 students on register), type (maintained, independent, residential, special provision), presence of a sixth form, and proportion of students eligible for free school meals (=17% or =17%), then randomised within strata in blocks of 2.<br><br> Consenting first-order contacts of a COVID-positive index case will receive daily contact testing for 7 days from the point of being notified they are a close contact. This will consist of a daily lateral flow device (LFD) test*. Those that receive a negative LFD result can attend school for that day, but other than travelling to and from school will be instructed to continue to self-isolate outside the school setting. Those that receive a positive LFD result should not attend school and will be instructed to self-isolate for 10 days according to national guidelines. The contacts of all first-order contacts (i.e. ‘second-order contacts’) will be identified to allow the determination of the secondary attack rate.<br><br> The control group will test individuals twice a week, followed by isolation of any positive cases and their contacts. The intervention group will follow the same twice-weekly testing for individuals, but any contacts of positive cases will be asked to test daily in school/college for 7 consecutive days as an alternative to self-isolation, and as long as they continue to test negative, they will be able to carry on going to school/college. The trial is voluntary. Participants who are part of active case finding can choose not to participate in DCT or drop out of DCT at any point.<br> | <br> Co-Primary End-Points:<br> 1. Number of school days missed among those eligible to be in school during the 9-week period of the study. Daily school attendances will be obtained from the school register and absences recorded with reconciliation with COVID-19 associated absences. This will be compared between study arms, to historic schools’ data, and to national schools’ benchmark data collected via a survey of non-participating schools.<br> 2. Estimated number of in-school COVID-19 transmission events during the 9-week period of the study: the number of positive cases will be obtained from the following sources:<br> 2.1. Weekly LFD active case finding (control and intervention arms) during the 9-week period of the study<br> 2.2. Symptomatic individuals’ NHS Test and Trace results obtained from Community Testing routine data (control and intervention arms) during the 9-week period of the study<br> 2.3. In-school LFD DCT testing (intervention arm) during the 9-week period of the study<br> Positivity rates will be reported for each source separately to facilitate like-for-like comparison between arms<br><br> Epidemiological links between cases will be obtained from the NHS Test & Trace Contact Tracing and Advice Service database. Additional links will be obtained by membership of school-reported contact groups. Onward transmission from the index case will be determined by the following:<br> 1. Genomic sequence of virus: the additional PCR swab collected from positive individuals will be used to determine the whole genomic sequence of isolates. A sample of apparent links will be assessed with comparisons of whole-genome sequencing. The diversity of genetic sequences both in the schools and the community (routinely determined by COG) will be used to help interpret the results. Preliminary work currently undertaken will determine the appropriate genetic distance to be used to exclude a direct transmission event between individuals. This is likely to be two SNPs.<br> 2. Plausible epidemiological link (e.g. membership of same close contact group)<br> 3. For positive individuals identified in DCT the DMIC will review all available data to determine if the individual’s infection was likely to have resulted from onward transmission from the index case, or via co-infection from an unknown ‘upstream’ positive or out-of-school positive case.<br> | | 30/06/2021 | | No | False | | |
| ISRCTN10182320 | 4 October 2021 | Monitoring the course of the COVID-19 epidemic in Estonia | COVID-19 active monitoring program in Estonia | | University of Tartu | 16/03/2021 | 20210316 | ISRCTN | https://www.isrctn.com/ISRCTN10182320 | Recruiting | No | | | Both | 23/04/2020 | 2000 | Observational | Surveillance study based on repeated cross-sectional surveys of the general population (recruited via stratified random sampling) (Screening) | Not Applicable | Estonia | | | | | | | Inclusion criteria: <br> 1. Adult, male or female<br> 2. Willing and able to give informed consent for participation in the study<br> | Exclusion criteria: Does not meet inclusion criteria | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | Randomly selected consenting adults are asked to visit national testing centers for a nasopharyngeal swab and fill out a web-based questionnaire. | SARS-CoV-2 prevalence measured using SARS-CoV-2 RNA RT-PCR at each of the cross-sectional study rounds (every month in 2020, six times a year in 2021, 2022/23 to be decided) | | 30/12/2023 | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04393558 | 11 October 2021 | Wearable Sensor to Monitor COVID-19 Like Signs and Symptoms | Wearable Sensor to Monitor COVID-19 Like Signs and Symptoms | | Shirley Ryan AbilityLab | 16/05/2020 | 20200516 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04393558 | Recruiting | No | 18 Years | 95 Years | All | April 20, 2020 | 100 | Observational | | | United States | ; ; | Arun Jayaraman, PhD;Lori McGee Koch;Lori McGee Koch, PhD | | ;Lmcgee@sralab.org;Lmcgee@sralab.org | ;312-238-2091;312-238-2091 | Shirley Ryan AbilityLab; |
<br> Inclusion Criteria:
<br>
<br> - Ages between 18-95 years old
<br>
<br> - Currently experiencing any COVID-like signs and symptoms such as fever, cough,
<br> shortness of breath, trouble breathing, persistent pain or pressure in the chest,
<br> confusion or inability to arouse, bluish lips or face.
<br>
<br> - Individuals who are not experience any COVID like signs and symptoms (will be asked to
<br> be healthy control)
<br>
<br> - Able and willing to give written consent and comply with study procedures.
<br>
<br> Exclusion Criteria:
<br>
<br> - Inability to understand instructions and follow a three step command.
<br>
<br> - The subject is pregnant, nursing or planning a pregnancy.
<br>
<br> - Inability to provide written consent.
<br> | | COVID-19;Healthy Control | Device: ADAM Sensor | Heart Rate Instantaneous heart rate every 15 minutes.;Respiratory frequency;Cough Frequency;Body temperature | | | | Yes | False | | |
| → | NCT04405076 | 11 October 2021 | Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 COVID-19 Vaccine in Adults Aged 18 Years and Older | A Phase 2a, Randomized, Observer-Blind, Placebo Controlled, Dose-Confirmation Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1273 SARS-COV-2 Vaccine in Adults Aged 18 Years and Older | | ModernaTX, Inc. | 13/05/2020 | 20200513 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04405076 | Not recruiting | No | 18 Years | N/A | All | May 29, 2020 | 660 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 2 | United States | | | | | | |
<br> Key Inclusion Criteria:
<br>
<br> Each participant must meet all of the following criteria during the screening period and at
<br> Day 1, unless noted otherwise, to be enrolled in this study:
<br>
<br> 1. Male or female, 18 years of age or older at the time of consent (Screening Visit, Day
<br> 0). For Part B, participants must have been previously enrolled in the mRNA-1273 P201
<br> study.
<br>
<br> 2. Understands and agrees to comply with the study procedures and provides written
<br> informed consent.
<br>
<br> 3. According to the assessment of the investigator, is in good general health and can
<br> comply with study procedures.
<br>
<br> 4. Female participants of nonchildbearing potential may be enrolled in the study.
<br> Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal
<br> ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as
<br> amenorrhea for =12 consecutive months prior to Screening (Day 0) without an
<br> alternative medical cause). A follicle-stimulating hormone (FSH) level may be measured
<br> at the discretion of the investigator to confirm postmenopausal status.
<br>
<br> 5. Female participants of childbearing potential may be enrolled in the study if the
<br> participant fulfills all the following criteria:
<br>
<br> - Has a negative pregnancy test at Screening (Day 0) and on the day of the first
<br> injection (Day 1).
<br>
<br> - Has practiced adequate contraception or has abstained from all activities that
<br> could result in pregnancy for at least 28 days prior to the first injection (Day
<br> 1).
<br>
<br> - Has agreed to continue adequate contraception through 3 months following the
<br> second injection (Day 29).
<br>
<br> - Is not currently breastfeeding.
<br>
<br> Adequate female contraception is defined as consistent and correct use of a Food and
<br> Drug Administration (FDA) approved contraceptive method in accordance with the product
<br> label. For example:
<br>
<br> - Barrier method (such as condoms, diaphragm, or cervical cap) used in conjunction
<br> with spermicide
<br>
<br> - Intrauterine device
<br>
<br> - Prescription hormonal contraceptive taken or administered via oral (pill),
<br> transdermal (patch), subdermal, or IM route
<br>
<br> - Sterilization of a female participant's monogamous male partner prior to entry
<br> into the study Note: periodic abstinence (for example, calendar, ovulation,
<br> symptothermal, post-ovulation methods) and withdrawal are not acceptable methods
<br> of contraception.
<br>
<br> 6. Male participants engaging in activity that could result in pregnancy of sexual
<br> partners must agree to practice adequate contraception from the time of the first
<br> injection and through 3 months after the last injection.
<br>
<br> Adequate contraception for male participants is defined as:
<br>
<br> - Monogamous relationship with a female partner using an intrauterine device or hormonal
<br> contraception (described above)
<br>
<br> - Use of barrier methods and spermicide
<br>
<br> - History of surgical sterilization
<br>
<br> - Male participants with partners who have become pregnant prior to Screening are
<br> eligible to participate in the study.
<br>
<br> Additional Key Inclusion Criteria for Part C
<br>
<br> 1. Participants must have been previously enrolled in the mRNA-1273-P301 study and must
<br> have received 2 doses of mRNA-1273 in Part A, has been unblinded and aware of their actual
<br> treatment in Study mRNA-1273-P301, must have been compliant in Study mRNA-1273-P301 (was
<br> not withdrawn or discontinued early), and has been at least 6 months since their second
<br> dose in Study mRNA-1273-P301 prior to enrollment in this part.
<br>
<br> Key Exclusion Criteria:
<br>
<br> Participants meeting any of the following criteria at the Screening Visit (Day 0) or at Day
<br> 1, unless noted otherwise, will be excluded from the study:
<br>
<br> 1. Pregnant or breastfeeding.
<br>
<br> 2. Is acutely ill or febrile 24 hours prior to or at the Screening Visit (Day 0). Fever
<br> is defined as a body temperature =38.0°Celsius/100.4°Fahrenheit. Participants meeting
<br> this criterion may be rescheduled within the relevant window periods. Afebrile
<br> participants with minor illnesses can be enrolled at the discretion of the
<br> investigator.
<br>
<br> 3. Current treatment with investigational agents for prophylaxis against COVID-19.
<br>
<br> 4. Has a medical, psychiatric, or occupational condition that may pose additional risk as
<br> a result of participation, or that could interfere with safety assessments or
<br> interpretation of results according to the investigator's judgment.
<br>
<br> 5. Is a healthcare worker or a member of an emergency response team.
<br>
<br> 6. Current use of any inhaled substance (for example, tobacco or cannabis smoke, nicotine
<br> vapors).
<br>
<br> 7. History of chronic smoking (=1 cigarette a day) within 1 year of the Screening Visit
<br> (Day 0).
<br>
<br> 8. History of illegal substance use or alcohol abuse within the past 2 years. This
<br> exclusion does not apply to historical cannabis use that was formerly illegal in the
<br> participant's state but is legal at the time of Screening.
<br>
<br> 9. Known history of hypertension, or systolic blood pressure >150 millimeter of mercury
<br> (mmHg) in participants in Cohort 1 (=18 to <55 years old) or systolic blood pressure
<br> >160 mmHg in participants in Cohort 2 (=55 years old) at the Screening Visit (Day 0).
<br>
<br> 10. Known history of hypotension or systolic blood pressure <85 mmHg at the Screening
<br> Visit (Day 0).
<br>
<br> 11. Diabetes mellitus
<br>
<br> 12. Diagnosis of chronic pulmonary disease (for example, chronic obstructive pulmonary
<br> disease, asthma)
<br>
<br> 13. Chronic cardiovascular disease
<br>
<br> 14. Resides in a nursing home
<br>
<br> 15. Grade 1 or higher toxicity on clinical safety laboratory testing at the Screening
<br> Visit (Day 0)
<br>
<br> 16. Current or previous diagnosis of immunocompromising condition, immune-mediated
<br> disease, or other immunosuppressive condition.
<br>
<br> 17. Received systemic immunosuppressants or immune-modifying drugs for >14 days in total
<br> within 6 months prior to the Screening Visit (Day 0) (for corticosteroids =20
<br> milligrams (mg)/day of prednisone equivalent). Topical tacrolimus is allowed if not
<br> used within 14 days prior to the Screening Visit (Day 0).
<br>
<br> 18. Anticipating the need for immunosuppressive treatment at any time during participation
<br> in the study.
<br>
<br> 19. Positive serology for hepatitis B virus surface antigen, hepatitis C virus antibody,
<br> or human immunodeficiency virus (HIV) type 1 or 2 antibodies identified at the
<br> Screening Visit (Day 0).
<br>
<br> 20. History of anaphylaxis, urticaria, or other significant AR requiring medical
<br> | | SARS-CoV-2 | Biological: Biological: mRNA-1273;Biological: Placebo;Biological: mRNA-1273.351 | Level of SARS-CoV-2-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA);Number of Participants with Abnormalities in Physical Examinations;Number of Participants with Abnormalities in Blood Pressure, Temperature, HR, or Respiratory Rate;Change from Baseline in the Measure of Clinical Safety Laboratory Values in Cohort 2;Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Medically-Attended Adverse Events (MAAEs);Number of Participants with Unsolicited Adverse Events (AEs);Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs)→Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs);Number of Participants with Unsolicited Adverse Events (AEs);Number of Participants with Medically-Attended Adverse Events (MAAEs);Number of Participants with Serious Adverse Events (SAEs);Change from Baseline in the Measure of Clinical Safety Laboratory Values in Cohort 2;Number of Participants with Abnormalities in Blood Pressure, Temperature, HR, or Respiratory Rate;Number of Participants with Abnormalities in Physical Examinations;Level of SARS-CoV-2-Specific Binding Antibody (bAb) as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) | | | | Yes | False | | |
| NCT04409873 | 11 October 2021 | Antiseptic Mouthwash / Pre-Procedural Rinse on SARS-CoV-2 Load (COVID-19) | Effect of Antiseptic Mouthwash/Gargling Solutions and Pre-procedural Rinse on SARS-CoV-2 Load (COVID-19) | AMPoL | University of California, San Francisco | 28/05/2020 | 20200528 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04409873 | Recruiting | No | 18 Years | N/A | All | March 31, 2021 | 150 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor). | Phase 2 | United States | ; ; | Stuart A Gansky, DrPH;Stuart A Gansky, DrPH;Stuart A Gansky, DrPH | | ;stuart.gansky@ucsf.edu;stuart.gansky@ucsf.edu | ;415-502-8094;415-502-8094 | Professor and Lee Hysan Chair of Oral Epidemiology; |
<br> Inclusion Criteria:
<br>
<br> - Tested positive for COVID-19 with a sample collected in the prior 7 days
<br>
<br> - Ability to read and speak English or Spanish
<br>
<br> - Ability to participate in the study for 4 weeks
<br>
<br> - Being asymptomatic or having mild or moderate symptoms (for example, sore throat,
<br> coughing, fever, fatigue)
<br>
<br> - Ability to rinse/gargle
<br>
<br> - Not having any condition that might worsen with gargling solutions
<br>
<br> - Not having a history of mouthwash sensitivity
<br>
<br> - Not having an allergy to any mouthwash that has been used before
<br>
<br> - Not using another mouthwash/gargling solution since the most recent positive test
<br>
<br> - Not taking antimicrobial medications (antibacterial, antiviral, antibiotics including
<br> off-label FDA-approved medications such as hydroxychloroquine)
<br>
<br> - Anticipated ability to participate in the study for 4 weeks
<br>
<br> - Have a cellphone and agree to receive text messages for reminders to use mouthwash
<br> during the day and for follow-up visits, and can videoconference (like zoom) on a
<br> cellphone, tablet, or computer for sample collection instructions
<br>
<br> Exclusion Criteria:
<br>
<br> - People who because of their symptoms intend to receive antiviral medications that
<br> could potentially affect viral load in their saliva samples
<br>
<br> - Pregnant or lactating women due to potential aversions to mouthwash solution
<br> taste/smell.
<br> | | COVID-19;SARS-CoV 2;Severe Acute Respiratory Syndrome Coronavirus 2;Virus Disease;Coronavirus Infections;Pharyngeal Diseases | Drug: Oral-B Mouth Sore mouthwash;Drug: Crest Pro-Health Multi-Protection mouthwash;Drug: CloSYS Ultra Sensitive Rinse mouthwash;Drug: Distilled water;Drug: Listerine Zero Mouthwash Product | Change in SARS-Cov-2 viral load | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04436276 | 11 October 2021 | A Study of Ad26.COV2.S in Adults (COVID-19) | A Randomized, Double-blind, Placebo-controlled Phase 1/2a Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26COVS1 in Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older | | Janssen Vaccines & Prevention B.V. | 15/06/2020 | 20200615 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04436276 | Not recruiting | No | 18 Years | N/A | All | July 15, 2020 | 1085 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Participant, Investigator). | Phase 1/Phase 2 | United States;Belgium;United States | | Janssen Vaccines & Prevention B.V. Clinical Trial | | | | Janssen Vaccines & Prevention B.V. |
<br> Inclusion criteria:
<br>
<br> - Participant must sign an informed consent form (ICF) indicating that he or she
<br> understands the purpose, procedures, and potential risks and benefits of the study,
<br> and is willing to participate in the study
<br>
<br> - All female participants of childbearing potential must have a negative highly
<br> sensitive urine pregnancy test at screening; and have a negative highly sensitive
<br> urine pregnancy test immediately prior to each study vaccine administration
<br>
<br> - Participant must have a body mass index (BMI) less than or equal to (<=) 30.0
<br> kilograms per square meter (kg/m^2)
<br>
<br> - Applicable to Cohorts 1 and 2 only: Participant must be healthy, in the investigator's
<br> clinical judgment, as confirmed by medical history, physical examination, clinical
<br> laboratory assessments, and vital signs performed at screening, and must not have
<br> comorbidities related to an increased risk of severe coronavirus disease-2019
<br> (COVID-19). Applicable to Cohort 3 only: In the investigator's clinical judgment,
<br> participant must be either in good or stable health Participants may have underlying
<br> illnesses such as hyperlipoproteinemia or hypothyroidism, as long as their symptoms
<br> and signs are medically controlled and not considered to be comorbidities related to
<br> an increased risk of severe COVID-19 (participants may have medical conditions of mild
<br> severity (according to the Toxicity Grading Scale), as long as it is stable and
<br> medically controlled as defined by no change in medication over the past 6 months
<br> (except for issues of tolerability or use of similar drug with same mechanism of
<br> action, for example, thiazides, Beta blockers, Alpha blockers at the same effective
<br> dose).
<br>
<br> Exclusion criteria:
<br>
<br> - Participant has a clinically significant acute illness (this does not include minor
<br> illnesses such as diarrhea or mild upper respiratory tract infection) or temperature
<br> greater than or equal to (>=) 38.0 degree Celsius within 24 hours prior to the planned
<br> first dose of study vaccine; randomization at a later date is permitted at the
<br> discretion of the investigator and after consultation with the sponsor
<br>
<br> - Participant has a history of malignancy within 5 years before screening (exceptions
<br> are squamous and basal cell carcinomas of the skin and carcinoma in situ of the
<br> cervix, or malignancy, which is considered cured with minimal risk of recurrence)
<br>
<br> - Participant has a history of any neurological disorders or seizures including
<br> Guillain-Barre syndrome, with the exception of febrile seizures during childhood
<br>
<br> - Participant has a positive diagnostic test result for SARS-CoV-2 infection confirmed
<br> by polymerase chain reaction (PCR) at screening
<br>
<br> - Participants with comorbidities that are or might be associated with an increased risk
<br> of progression to severe COVID-19, that is, participants with moderate-to-severe
<br> asthma; chronic lung diseases such as chronic obstructive pulmonary disease (COPD)
<br> (including emphysema and chronic bronchitis), idiopathic pulmonary fibrosis and cystic
<br> fibrosis; diabetes (including type 1 or type 2); serious heart conditions, including
<br> heart failure, coronary artery disease, congenital heart disease, cardiomyopathies,
<br> and (pulmonary) hypertension or high blood pressure; obesity (BMI >= 30 kg/m^2);
<br> chronic liver disease, including cirrhosis; sickle cell disease; thalassemia;
<br> cerebrovascular disease; neurologic conditions (dementia); smoking end stage renal
<br> disease; organ transplantation; cancer; HIV infection and other immunodeficiencies;
<br> hepatitis B infection; and sleep apnea. Applicable to Cohort 3 only: Participants may
<br> have hypertension of mild severity (according to the Toxicity Grading Scale), as long
<br> as it is stable and medically controlled as defined by no change in medication over
<br> the past 6 months (except for issues of tolerability or use of similar drug with same
<br> mechanism of action, for example, thiazides, Beta blockers, Alpha blockers at the same
<br> effective dose)
<br>
<br> - Applicable to Cohorts 1 and 3 only: Participant currently working in an occupation
<br> with a high risk of exposure to SARS-CoV-2 (for example, health care worker or
<br> emergency response personnel) or considered at the investigator's discretion to be at
<br> increased risk to acquire COVID-19 for any other reason
<br> | | Healthy | Biological: Ad26.COV2.S;Biological: Placebo | Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the Second Vaccination;Cohort 2: Number of Participants with AESIs from the First Vaccination until 6 Months after the First Vaccination;Cohorts 1 and 3: Number of Participants with Adverse Events of Special Interest (AESIs) from the First Vaccination until 2 Years after the Second Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the Second Vaccination;Cohort 2: Number of Participants with SAEs from the First Vaccination until 6 Months after the First Vaccination;Cohorts 1 and 3: Number of Participants with Serious Adverse Events (SAEs) from the First Vaccination until 2 Years after the Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Unsolicited AEs for 28 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Systemic AEs for 7 Days after First Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after Second Vaccination;Cohorts 1, 2, and 3: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days after First Vaccination | | | | Yes | False | | |
| → | NCT04441372 | 11 October 2021 | Prognostication of Oxygen Requirement in Non-severe SARS-CoV-2 Infection | Prognostication of Oxygen Requirement in Non-severe SARS-CoV-2 Infection | PRIORITISE | Medecins Sans Frontieres, Spain | 17/06/2020 | 20200617 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04441372 | Recruiting | No | 18 Years | N/A | All | October 1, 2020 | 600 | Observational [Patient Registry] | | | Brazil;India;Brazil;India;Bangladesh→Bangladesh;India;Brazil;India;Brazil | ; ; ; | Arjun Chandna, MD;Sakib Burza, PhD;Mikhael Yosia, MD;Andre Siqueiria | | ;;msfe-jakarta-med@barcelona.msf.org; | ;;+6281378778784; | Cambodia Oxford Medical Research Unit;Medecins Sans Frontieres, Spain; |
<br> Inclusion Criteria
<br>
<br> The participant may enter the study if ALL of the following apply:
<br>
<br> 1. Aged = 18 years, and willing and able to give informed consent and comply with study
<br> procedures;
<br>
<br> 2. RT-PCR or antigen test positive for SARS-CoV-2 during current illness
<br>
<br> 3. Systemic manifestation of SARS-CoV-2 infection defined as:
<br>
<br> Breathing difficulty
<br>
<br> OR
<br>
<br> History of fever during current illness AND chest pain OR abdominal pain OR loose stool OR
<br> severe myalgia
<br>
<br> Exclusion Criteria
<br>
<br> The participant may not enter the study if ANY of the following apply:
<br>
<br> 1. Requires supplemental oxygen or mechanical ventilation (invasive / non-invasive) at
<br> presentation;
<br>
<br> 2. Laboratory confirmed SARS-CoV-2 infection (virological or serological) during a
<br> previous illness episode.
<br>
<br> 3. Documented history of Vaccination for SARS-Cov-2
<br> | | SARS-CoV2;COVID | | Clinical and biochemical prognostic markers | | | | Yes | False | | |
| → | NCT04447209 | 11 October 2021 | Dietary Diversity of Young Children During CoVID-19 Outbreak: A Longitudinal Study | Dietary Diversity of Young Children During CoVID-19 Outbreak: A Longitudinal Study | CoDDYC | University of Malaya | 17/06/2020 | 20200617 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04447209 | Not recruiting | No | 6 Months | 6 Years | All | June 6, 2020 | 400 | Observational | | | Malaysia | | Mohammad Y Jalaludin, MBBS MPaeds | | | | University of Malaya Medical Center |
<br> Inclusion Criteria:
<br>
<br> - All well-children aged between 6 months and 6 years
<br>
<br> Exclusion Criteria:
<br>
<br> - Children with chronic illnesses
<br> | | Dietary Diversity | Other: Dietary counselling on Food Groups according to IYC Feeding practices, WHO | Meal frequencies in past 24 hours;Weight;Height;Minimal Dietary Diversity (MDD) of more than 5 food groups in 24 hours→Minimal Dietary Diversity (MDD) of more than 5 food groups in 24 hours;Height;Weight;Meal frequencies in past 24 hours | | | | Yes | False | | |
| NCT04449731 | 11 October 2021 | Changes in Dietary Behaviours During the COVID-19 Outbreak Confinement in the Adult Population (COVIDiet_Int) | Changes in Dietary Behaviours During the COVID-19 Outbreak Confinement in the Adult Population | COVIDiet_Int | Universidad de Granada | 23/06/2020 | 20200623 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04449731 | Not recruiting | No | 18 Years | N/A | All | March 20, 2020 | 35000 | Observational | | | Spain | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Adults aged from 18 years old and over living in the countries involved in the study.
<br>
<br> Exclusion Criteria:
<br>
<br> - People under 18 years of age living in countries different from those involved in the
<br> study.
<br> | | COVID-19 | | Adherence to the Mediterranean diet before and during the COVID-19 confinement;Eating behaviours | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04527081 | 11 October 2021 | Study of COVID-19 DNA Vaccine (AG0302-COVID19) | A Randomized, Open-label, Non-controlled Phase I/II Study to Assess Safety and Immunogenicity of Twice or Three Times Dosing of Intramuscular AG0302-COVID19 (2mg) in Healthy Adults | | AnGes, Inc. | 24/08/2020 | 20200824 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04527081 | Not recruiting | No | 20 Years | 65 Years | All | August 31, 2020 | 30 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1/Phase 2 | Japan | | AnGes, Inc. Clinical Development | | | | AnGes, Inc. |
<br> Inclusion Criteria:
<br>
<br> 1. Subjects who have obtained written consent voluntarily to participate in this clinical
<br> trial
<br>
<br> 2. Subjects whose age at the time of obtaining consent is 20 years to 65 years
<br>
<br> 3. Subjects who are negative for SARS-CoV-2 by PCR test
<br>
<br> 4. Subjects who are negative for both SARS-CoV-2 IgM antibody and SARS-CoV-2 IgG antibody
<br> by antibody test
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subjects with symptoms of suspected COVID-19 infection (respiratory symptoms,
<br> headache, malaise, olfactory disorders, taste disorders, etc.)
<br>
<br> 2. Subjects with a history of COVID-19 (hearing from subjects)
<br>
<br> 3. Subjects who have participated in unapproved vaccine clinical trials
<br>
<br> 4. Subjects with axillary temperature of 37.0 degree or higher
<br>
<br> 5. Subjects who have a history of anaphylaxis
<br>
<br> 6. Subjects who have a current or history of serious renal, cardiovascular, respiratory,
<br> liver, kidney, gastrointestinal, and neuropsychiatric diseases
<br>
<br> 7. Subjects with a history of convulsion or epilepsy
<br>
<br> 8. Subjects with a history of diagnosis of immunodeficiency
<br>
<br> 9. Subjects who have a close relative (within 3rd degree) of congenital immunodeficiency
<br>
<br> 10. Subjects who have current bronchial asthma
<br>
<br> 11. Subjects who had a fever of 39.0°C or higher within 2 days after the last vaccination,
<br> and those who suspected allergy such as a systemic rash
<br>
<br> 12. Females who wish to become pregnant from the date of study registration to 12 weeks
<br> after the first inoculation of the investigational drug, and pregnant females who are
<br> breast-feeding. In addition, females who may become pregnant and their male sexual
<br> partners should use appropriate contraceptives (pill), condoms, vasectomy, tubal
<br> ligation, diaphragm, intrauterine devices, spermicides, intrauterine hormone-releasing
<br> system, etc. from the study entry date until 12 weeks after the first vaccination
<br>
<br> 13. Subjects who have participated in clinical trials of other unapproved drugs and
<br> received the investigational drug within 4 weeks before the start of this clinical
<br> trial (starting from vaccination day)
<br>
<br> 14. Subjects who have been received a live vaccine, inactivated vaccine, or toxoid within
<br> 4 weeks before the start of this clinical trial (starting from vaccination day)
<br>
<br> 15. Subjects who have been administered with drugs that affect the immune system
<br> (excluding external preparations) such as immunomodulators (DMARDs, etc.),
<br> immunosuppressants, biologics, etc. within 4 weeks before vaccination
<br>
<br> 16. Subjects who received blood transfusion or gamma globulin therapy within 12 week
<br> before vaccination, or high-dose gamma globulin therapy (200 mg/kg or more) within 24
<br> weeks before vaccination
<br>
<br> 17. Subjects who have a history of overseas travel within 4 weeks before the start of the
<br> clinical trial (starting from vaccination day)
<br>
<br> 18. Subjects who are unable to comply with the clinical trial protocol and follow up (for
<br> mental, family, social or geographical reasons)
<br>
<br> 19. Subjects who are judged to be ineligible for this clinical trial by the investigator
<br> | | COVID-19 | Biological: AG0302-COVID19;Biological: AG0302-COVID19;Biological: AG0302-COVID19 | Immunogenicity;Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | | | | Yes | False | | |
| → | NCT04537650 | 11 October 2021 | Swallowing Impairment After COVID-19 Infection | The Pathophysiology of Swallowing Impairment in People Recovering From COVID-19 | | University Health Network, Toronto | 01/09/2020 | 20200901 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04537650 | Recruiting | No | 18 Years | N/A | All | January 1, 2021 | 75 | Observational | | | United States;Canada;United States | | Catriona M Steele, PhD | | | | University Health Network, Toronto |
<br> Inclusion Criteria:
<br>
<br> - People who tested positive or received a presumed positive diagnosis of COVID-19
<br> infection not earlier than March 1, 2020 and who are at least 2 weeks post positive
<br> diagnosis and the initiation of medical management of COVID-19 infection
<br>
<br> - Adequate comprehension of English to understand the consent form and follow study
<br> instructions
<br>
<br> Exclusion Criteria:
<br>
<br> - Age under 18 years old
<br>
<br> - Current pregnancy
<br> | | Covid19 | Diagnostic Test: Videofluoroscopic Swallowing Study (VFSS) | Swallowing efficiency;Swallowing safety→Swallowing safety;Swallowing efficiency | | | | Yes | False | | |
| NCT04540393 | 11 October 2021 | AZD1222 Vaccine for the Prevention of COVID-19 | A Phase III Open-label Study in Adults to Determine the Safety and Immunogenicity of AZD1222, a Non-replicating ChAdOx1 Vector Vaccine, for the Prevention of COVID-19 | | AstraZeneca | 26/08/2020 | 20200826 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04540393 | Not recruiting | No | 18 Years | 130 Years | All | September 2, 2020 | 0 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 3 | Russian Federation | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Participant must be = 18 years of age at the time of signing the informed consent.
<br>
<br> 2. Medically stable such that, according to the judgment of the investigator,
<br> hospitalization within the study period is not anticipated and the participant appears
<br> likely to be able to remain in follow-up through the end of protocol-specified
<br> follow-up.
<br>
<br> - A stable medical condition is defined as disease not requiring significant change
<br> in therapy or hospitalization for worsening disease during the 3 months prior to
<br> enrolment
<br>
<br> 3. Able to understand and comply with study requirements/procedures based on the
<br> assessment of the investigator.
<br>
<br> 4. Male and/or female
<br>
<br> 5. Female participants
<br>
<br> 1. Women of childbearing potential must:
<br>
<br> - Have a negative pregnancy test on the day of screening and on Day 1
<br>
<br> - Use one highly effective form of birth control for at least 28 days prior to
<br> Day 1 and agree to continue using one highly effective form of birth control
<br> through 60 days following administration of the second dose of study
<br> intervention. A highly effective method of contraception is defined as one
<br> that can achieve a failure rate of less than 1% per year when used
<br> consistently and correctly. Periodic abstinence, the rhythm method, and
<br> withdrawal are NOT acceptable methods of contraception.
<br>
<br> 2. Women are considered of childbearing potential unless they meet either of the
<br> following criteria:
<br>
<br> - Surgically sterilised (including bilateral tubal ligation, bilateral
<br> ophorectomy, or hysterectomy), or
<br>
<br> - Postmenopausal
<br>
<br> - For women aged < 50 years, postmenopausal is defined as having both:
<br>
<br> - A history of = 12 months amenorrhea prior to first dosing, without an
<br> alternative cause, following cessation of exogenous sex-hormonal
<br> treatment, and
<br>
<br> - A follicle-stimulating hormone level in the post-menopausal range Until
<br> follicle-stimulating hormone is documented to be within menopausal
<br> range, the participant is to be considered of childbearing potential
<br>
<br> - For women aged = 50 years, postmenopausal is defined as having a history of
<br> = 12 months amenorrhea prior to first dosing, without an alternative cause,
<br> following cessation of exogenous sex-hormonal treatment
<br>
<br> 6. Capable of giving signed informed consent which includes compliance with the
<br> requirements and restrictions listed in the ICF and in the protocol
<br>
<br> Exclusion Criteria:
<br>
<br> 1. History of allergic disease or reactions likely to be exacerbated by any component of
<br> AZD1222.
<br>
<br> 2. Active infection with SARS-CoV-2 as confirmed by RT-PCR.
<br>
<br> 3. Known past laboratory-confirmed SARS-CoV-2 infection. Note: Participant's baseline
<br> serostatus determined as part of the study will not be used as a basis for exclusion
<br> from the study.
<br>
<br> 4. Significant infection or other acute illness, including fever > 37.8°C on the day
<br> prior to or day of first dosing.
<br>
<br> 5. Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV
<br> infection; asplenia; recurrent severe infections and use of immunosuppressant
<br> medication within the past 6 months (= 20 mg/kg/day of prednisone or its equivalent,
<br> given daily or on alternate days for = 15 days within 30 days prior to administration
<br> of study intervention), except topical/inhaled steroids or short-term oral steroids
<br> (course lasting
<br>
<br> = 14 days).
<br>
<br> 1. Note: HIV-positive participants with CD4 counts > 500 for = 12 months and on a
<br> stable HIV antiretroviral regimen may be enrolled
<br>
<br> 2. Note: Topical tacrolimus is allowed if not used within 14 days prior to the day
<br> of erolment.
<br>
<br> 6. History of primary malignancy except for:
<br>
<br> 1. Malignancy with low potential risk for recurrence after curative treatment (for
<br> example, history of childhood leukaemia) or metastasis (for example, indolent
<br> prostate cancer) in the opinion of the site investigator.
<br>
<br> 2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence
<br> of disease
<br>
<br> 3. Adequately treated uterine cervical carcinoma in situ without evidence of disease
<br>
<br> 4. Localised prostate cancer
<br>
<br> 7. Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or
<br> platelet disorder), or prior history of significant bleeding or bruising following IM
<br> injections or venepuncture.
<br>
<br> 8. Severe and/or uncontrolled cardiovascular disease, respiratory disease,
<br> gastrointestinal disease, liver disease, renal disease, endocrine disorder, and
<br> neurological illness, as judged by the investigator (mild/moderate well-controlled
<br> comorbidities are allowed).
<br>
<br> 9. History of Guillain-Barré syndrome, or other neuroimmunological disease.
<br>
<br> 10. Any other significant disease, disorder, or finding that may significantly increase
<br> the risk to the participant, affect the ability of the participant to participate in
<br> the study, or impair interpretation of the study data.
<br>
<br> 11. Receipt of, or planned receipt of investigational products indicated for the treatment
<br> or prevention of SARS-CoV-2 or COVID-19. Note: For participants in the study who
<br> become hospitalised with COVID-19, receipt of licensed treatment options and/or
<br> participation in investigational treatment studies is permitted.
<br>
<br> 12. Receipt of any vaccine (licensed or investigational) other than licensed influenza
<br> vaccines within 30 days prior to and after administration of study intervention.
<br>
<br> 13. Receipt of any influenza vaccine (licensed or investigational) within 7 days prior to
<br> and after administration of study intervention.
<br>
<br> 14. Receipt of immunoglobulins and/or any blood products within 3 months prior to
<br> administration of study intervention or expected receipt during the period of study
<br> follow-up.
<br>
<br> 15. Involvement in the planning and/or conduct of the study (applies to both Sponsor staff
<br> and/or staff at the study site).
<br>
<br> 16. For women only - currently pregnant (confirmed with positive pregnancy test) or
<br> breastfeeding
<br>
<br> 17. Judgment by the investigator that the participant should not participate in the study
<br> if the participant is unlikely to comply with study procedures, restrictions, and
<br> requirements.
<br>
<br> 18. Previous enrolme | | COVID-19 | Biological: AZD1222 | Incidence of SAEs following the first vaccination and throughout the study duration (Day 180) [Safety and Tolerability]. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04766931 | 11 October 2021 | The Safety and Efficacy of FB2001 in Healthy Subjects and Patients With COVID-19 Infection | A Two-part, Phase I/II, Multi-center, Double-Blind, Randomized, Vehicle-controlled Study of the Safety and Efficacy of FB2001 in Patients With Moderate to Severe Coronavirus Disease 2019 (COVID-19) Infection | | Frontier Biotechnologies Inc. | 04/02/2021 | 20210204 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04766931 | Recruiting | No | 18 Years | 60 Years | All | March 26, 2021 | 72 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1 | United States | ; ; | Cheng Yao;Xiaomei Wang, MS;Gregory Tracey | | ;wangxiaomei@frontierbiotech.com; | ;610-888-3658; | Frontier Biotechnologies Inc.; |
<br> Inclusion Criteria:
<br>
<br> Subjects are required to meet ALL of the following criteria for enrollment into the Part 1
<br> of the study:
<br>
<br> 1. Male or female adults who are between 18 and 60 years old inclusive;
<br>
<br> 2. Weigh at least 45kg, with a BMI of 19 to 30 kg/m2 inclusive;
<br>
<br> 3. No serious underlying disease which would adversely affect the study conduct and data
<br> interpretation per the investigator;
<br>
<br> 4. Female subjects should have negative results in serum pregnancy test at screening and
<br> negative urine pregnancy test at admission:
<br>
<br> 1. Subjects of reproductive age and their partners agree to take 2 forms of
<br> effective contraceptive measures. Note: Using a medically acceptable form of
<br> birth control for at least 1 month prior to screening (3 months on oral
<br> contraceptives) [e.g., hormonal contraceptives (oral, patch, injectable or
<br> vaginal ring), implantable device (implantable rod or intrauterine device), or a
<br> double barrier (e.g., diaphragm, cervical cap, oral, patch or vaginal hormonal
<br> contraceptive, condom, spermicide, or sponge)]
<br>
<br> 2. Surgically sterile, with documentation, for at least 3 months prior to screening
<br> by one of the following means:
<br>
<br> Bilateral tubal ligation, Bilateral salpingectomy (with or without oophorectomy),
<br> Surgical hysterectomy, Bilateral oophorectomy (with or without hysterectomy),
<br> Postmenopausal, defined as the following: Last menstrual period greater than 12
<br> months prior to screening
<br>
<br> 3. Postmenopausal status confirmed by serum follicle stimulating hormone (FSH) and
<br> estradiol levels at screening
<br>
<br> 5. Agree to refrain from alcohol during the study;
<br>
<br> 6. Subjects should have normal (or abnormal but not clinically significant) laboratory
<br> results per the PI's judgement including the complete blood count, biochemistry,
<br> coagulation indices and urinalysis;
<br>
<br> 7. Subjects should have a normal (or abnormal but not clinically significant) ECG and
<br> chest X-ray at screening;
<br>
<br> 8. Subjects should be willing to cooperate and able to participate in this study, comply
<br> with all protocol requirements, and sign an informed consent;
<br>
<br> 9. Male subjects with female partners of childbearing potential must agree to use condoms
<br> for the duration of the study and until 12 weeks after completion of dosing with the
<br> study drug and must refrain from donating sperm for this same period;
<br>
<br> 10. Current non-smokers and those who have not smoked within the last 6 months. This
<br> includes the use of cigarettes, e-cigarettes, and nicotine replacement products.
<br>
<br> Exclusion Criteria:
<br>
<br> Subjects are required to meet NONE of the following criteria for enrollment into the Part 1
<br> of the study:
<br>
<br> 1. HIV antibody positive;
<br>
<br> 2. HbsAg positive;
<br>
<br> 3. HCV antibody positive;
<br>
<br> 4. History of tuberculosis or lung disease as reported by subject;
<br>
<br> 5. As reported by the subject has severe cardiovascular disease, neurological disease,
<br> hematological disease, infectious disease, mental disorder, liver disease,
<br> gastrointestinal disease, lung disease, endocrine disease,immune disease or kidney
<br> disease, or has a history of the above diseases, or other symptoms known to interfere
<br> with the absorption, distribution, metabolism, or excretion of the medicine, or other
<br> conditions that the investigator believes will increase the risk of the subject and
<br> might interfere with the study conduct and results interpretation
<br>
<br> 6. Female subjects who are pregnant, lactating or have pregnancy plans in the 3 months
<br> after their study completion;
<br>
<br> 7. Subjects who participated in any other clinical study within 30 days prior to
<br> screening;
<br>
<br> 8. Subjects with known allergic reactions to the study drug or its excipients;
<br>
<br> 9. Use of any medication, including prescription or over the counter, vitamins, herbal
<br> and/or mineral supplements, dietary supplements (and/or grape fruit juice) within 14
<br> days prior to the first treatment or during the trial, which in the opinion of the
<br> investigator may influence the trial results or the safety of the subjects:
<br>
<br> 1. Poor venous access or issues with needle sticks, e.g., syncope
<br>
<br> 2. Donated or lost >500 mL of blood in the previous 3 months
<br>
<br> 3. A history of prescription drug abuse, illicit drug use within 9 months prior to
<br> screening
<br>
<br> 4. A positive screen for alcohol or drugs of abuse at screening or admission
<br>
<br> 10. Any other clinical condition that, in the Investigator's judgment, would potentially
<br> compromise study compliance or the ability to evaluate safety/efficacy.
<br> | | Covid19 | Drug: FB2001;Drug: FB2001 Placebo | Pharmacokinetic parameters(AUC0-t);Pharmacokinetic parameters(Cmax);Number of participants with treatment-related adverse events as assessed by CTCAE V4.0;The Maximum Tolerable Dose (MTD) | | | | Yes | False | | |
| → | NCT04773665 | 11 October 2021 | Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidates VBI-2902a and VBI-2905a | A Phase 1a/1b, Randomized, Observer-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of the COVID-19 (SARS-CoV-2) Vaccine Candidates VBI-2902a and VBI-2905a in Healthy Adults | | VBI Vaccines Inc. | 24/02/2021 | 20210224 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04773665 | Recruiting | No | 18 Years | 54 Years | All | March 15, 2021 | 141 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor). | Phase 1 | Mexico;Canada;Mexico;Canada→Canada;Mexico;Canada;Mexico | ; ; | Joanne M Langley, MD;William Cameron, MD;Francisco Diaz-Mitoma, MD, PhD | | ;;fdiazmitoma@vbivaccines.com | ;;613-729-4200 | Canadian Center for Vaccinology;Ottawa Hospital; |
<br> Inclusion Criteria:
<br>
<br> To be eligible for the study, each participant must satisfy all of the following criteria:
<br>
<br> 1. Healthy female and male participants 18 -54 years of age.
<br>
<br> 2. If female:
<br>
<br> 1. is of childbearing potential and must have a negative pregnancy test prior to
<br> study vaccinations and agree to use an effective method of birth control as
<br> deemed appropriate by the investigator (e.g., hormonal contraceptive, barrier
<br> contraceptive with additional spermicide, or an intrauterine device) beginning
<br> >30 days prior to the first study vaccine administration and continuing until the
<br> end of the study.
<br>
<br> OR
<br>
<br> 2. is not of childbearing potential, defined as postmenopausal (12 months with no
<br> menses without an alternative medical cause) or surgically sterile (bilateral
<br> tubal ligation, bilateral oophorectomy orhysterectomy).
<br>
<br> 3. Phase 1b, groups G4 and 5 only: previously received a full course (2 doses) of an
<br> authorized S protein mRNA COVID-19 vaccine (e.g. COVID-19 vaccines produced by
<br> Pfizer/BioNTech or Moderna) at least 4 months prior to enrollment.
<br>
<br> 4. Sign an informed consent document indicating understanding of the purpose of and
<br> procedures required for the study and willingness to participate in the study.
<br>
<br> Exclusion Criteria
<br>
<br> Participants with any of the following criteria will be excluded:
<br>
<br> 1. History of clinical or laboratory diagnosis of COVID-19 or SARS-CoV-2 infection.
<br>
<br> 2. Phase 1b, groups G4 and G5 only: Previous receipt of an experimental or authorized
<br> SARS-CoV-2 (COVID-19) vaccines other than an S-protein mRNA vaccine.
<br>
<br> 3. Phase 1a and Phase 1b, group G6 only: Previous receipt of an experimental or
<br> authorized SARS-CoV-2 (COVID-19) vaccine.
<br>
<br> 4. Positive PCR or rapid antigen test for SARS-CoV-2 at screening.
<br>
<br> 5. Individuals with chronic medical conditions, including any of the following:
<br>
<br> 1. Diabetes mellitus Type 1 or Type 2
<br>
<br> 2. Chronic pulmonary disease (e.g., COPD or Asthma)
<br>
<br> 3. Hypertension (e.g., SBP >140 mmHg or DBP >90 mmHg)
<br>
<br> 4. Chronic kidney disease (e.g., GFR <60 mL/min/1.73 m2)
<br>
<br> 5. Chronic liver disease
<br>
<br> 6. Obesity (e.g., BMI >30 kg/m2)
<br>
<br> 6. Any history of cancer requiring chemotherapy or radiation within 5years.
<br>
<br> 7. Other medical or psychiatric condition including recent (within the past year) or
<br> active suicidal ideation/behavior or laboratory abnormality that may increase the risk
<br> of study participation or, in the investigator's judgment, make the participant
<br> inappropriate for the study.
<br>
<br> 8. Lack of participant's capacity (mental, social, behavioral), in the investigator's
<br> judgement, to provide informed consent for participation in the study.
<br>
<br> 9. Known or suspected impairment of immunological function, including but not limited to
<br> autoimmune diseases:
<br>
<br> 1. autoimmune diseases (e.g. multiple sclerosis, type 1 diabetes, myasthenia gravis,
<br> Crohn disease and other inflammatory bowel diseases, celiac disease, systemic
<br> lupus erythematosus, scleroderma, including diffuse systemic form and CREST
<br> syndrome, systemic sclerosis, dermatomyositis polymyositis, rheumatoid arthritis,
<br> juvenile idiopathic arthritis, autoimmune thyroiditis - including Hashimoto
<br> thyroiditis, Grave's or Basedow's disease, immune thrombocytopenic purpura,
<br> autoimmune hemolytic anemia, autoimmune hepatitis, psoriasis, vitiligo,
<br> vasculitis, Guillain- Barré syndrome, Transverse myelitis, Addison's disease,
<br> Bell's Palsy and Alopecia Areata);
<br>
<br> 2. secondary immunodeficiency disorders (e.g., Acquired Immunodeficiency Syndrome
<br> caused by Human Immunodeficiency Virus infection (HIV/AIDS), solid organ
<br> transplant,splenectomy);
<br>
<br> 3. primary immunodeficiency disorders (e.g., common variable immune deficiency
<br> (CVID), Defective phagocytic cell function and neutropenia syndromes, complement
<br> deficiency).
<br>
<br> 10. History of allergic reactions or anaphylactic reaction to any vaccine component.
<br>
<br> 11. Known infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV), or
<br> hepatitis B virus (HBV).
<br>
<br> 12. Pregnant or breastfeeding or plans to conceive from 2 weeks before the study until the
<br> end of study.
<br>
<br> 13. Clinically significant abnormal physical examination, vital signs, or clinically
<br> significant abnormal values for hematology, serum chemistry or urinalysis at screening
<br> as determined by the investigator.
<br>
<br> 14. Any laboratory test abnormality that would be considered of Grade 1 severity or above
<br> (as per FDA grading guidelines) and is considered as clinically significant by the
<br> investigator. Grade 2 severity or above is exclusionary, regardless of clinical
<br> assessment.
<br>
<br> 15. Has received blood products or immunoglobulin within 90 days of enrollment or is
<br> likely to require blood products during the study period.
<br>
<br> 16. Chronic administration (defined as more than 14 days in total) of immune-suppressive
<br> or other immune-modifying drug within six months prior to the product dose (for
<br> corticosteroids, this is defined as prednisone =20 mg/day or equivalent). Inhaled and
<br> topical steroids are allowed.
<br>
<br> 17. Immunization with attenuated vaccines (e.g., measles, mumps, and rubella vaccine)
<br> within 4 weeks prior to enrollment.
<br>
<br> 18. Immunization with inactivated vaccines (e.g., influenza) within 2 weeks prior to
<br> enrolment.
<br>
<br> 19. Participation in another clinical study within 30 days.
<br>
<br> 20. Any skin abnormality or tattoo that would limit post-vaccination injection site
<br> assessment.
<br>
<br> 21. Family members of study site personnel.
<br> | | Covid19 | Biological: VBI-2902a;Biological: Placebo;Biological: VBI-2905a | Rate and severity of laboratory abnormalities (hematology, biochemistry, urinalysis);Adverse events leading to study discontinuation;Adverse events leading to discontinuation of study vaccination;Rate of serious adverse events after each study vaccination;Rate and severity of medically attended adverse events after each study vaccination;Rate and severity of unsolicited adverse events after each study vaccination;Rate and severity of local and systemic solicited adverse events after each study vaccination | | | | Yes | False | | |
| NCT04779541 | 11 October 2021 | National Survey Concerning Vaccination Against COVID-19 in Nursing Homes and Long-Term Care Units | National Survey Concerning Vaccination Against COVID-19 in Nursing Homes and Long-Term Care Units | VACOVID-SENIOR | University Hospital, Angers | 01/03/2021 | 20210301 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04779541 | Not recruiting | No | 75 Years | N/A | All | June 2, 2021 | 323 | Observational | | | France | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - People aged 75 years and older in retirement homes or long-term care units who have
<br> accepted the SARS CoV-2 vaccine
<br>
<br> - People aged 75 years and older in retirement homes or long-term care units who have
<br> refused the SARS CoV-2 vaccine
<br>
<br> - National survey in france
<br>
<br> Exclusion Criteria:
<br>
<br> - Opposition of the elderly person and/or his or her relatives
<br> | | SARS-CoV-2;Covid19 | Other: observation | Acceptance rate of the SARS-CoV-2 vaccine among people living in nursing homes and long-term care units | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04810065 | 11 October 2021 | SingStrong: Strong Lungs Through Song - Long COVID-19 Study | SingStrong: Strong Lungs Through Song | ss | University of Limerick | 19/03/2021 | 20210319 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04810065 | Not recruiting | No | 18 Years | N/A | All | March 29, 2021 | 30 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Ireland | | Roisin Cahalan, PhD | | | | University of Limerick |
<br> Inclusion Criteria:
<br>
<br> - 18 years of age or older
<br>
<br> - Previous clinical diagnosis of Covid-19
<br>
<br> - Ongoing issues with any or all of: Shortness of breath, disordered breathing, reduced
<br> exercise tolerance
<br>
<br> - Good written and spoken English language
<br>
<br> Exclusion Criteria:
<br>
<br> - Lack of a confirmed Covid-19 diagnosis
<br>
<br> - Currently undergoing a similar singing or breathing retraining intervention
<br>
<br> - No residual problems from a confirmed case of Covid-19
<br> | | Long Covid | Other: SingStrong: Strong lungs through Song | Covid-19 Yorkshire Rehab Screen (C19YRS) | | | | Yes | False | | |
| → | NCT04818892 | 11 October 2021 | Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease | Immunogenicity of COVID-19 Vaccine in Patients With Inflammatory Bowel Disease | | University of Wisconsin, Madison | 25/03/2021 | 20210325 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04818892 | Recruiting | No | 18 Years | 85 Years | All | March 26, 2021 | 260 | Observational | | | United States | ; ; | Freddy Caldera, DO, MS;Daniel Griese;Daniel Griese | | ;djgriese@clinicaltrials.wisc.edu; | ;(608) 262-1632;608-262-1632 | UW School of Medicine and Public Health; |
<br> Inclusion Criteria:
<br>
<br> For mRNA cohort:
<br>
<br> - Participant has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by
<br> standard clinical, radiographic, endoscopic, and histopathologic criteria.
<br>
<br> - On one of the following treatment regimens:
<br>
<br> - Group A: Non-systemic immunosuppressive Group at least 75 participants
<br>
<br> - Mesalamine monotherapy or no therapy for IBD
<br>
<br> - Vedolizumab Therapy Group: on either vedolizumab monotherapy or combination
<br> therapy with methotrexate or azathioprine
<br>
<br> - Group B: Systemic immunosuppressive Group at least 75 participants
<br>
<br> - Thiopurine Therapy Group: on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg
<br>
<br> - Anti-TNF Therapy Group: on maintenance therapy infliximab (at least 8 every
<br> 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks),
<br> or certolizumab (at least monthly)
<br>
<br> - Anti-TNF Combination Therapy Group: on anti-TNF therapy as described above
<br> along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or
<br> 6MP 0.5mg/kg
<br>
<br> - Ustekinumab Therapy Group: on either ustekinumab monotherapy or combination
<br> therapy with methotrexate or azathioprine.
<br>
<br> - Tofacitinib Therapy Group: on tofacitinib at least 5mg PO BID
<br>
<br> - Corticosteroid Therapy Group: on any one of the systemic immunosuppressive
<br> groups and any dose of corticosteroids
<br>
<br> - Participant has been on the same IBD treatment for at least two months.
<br>
<br> - Participant is receiving an mRNA COVID-19 vaccine per standard of care recommended by
<br> their clinical provider or has started the COVID-19 series or finished the mRNA
<br> COVID-19 vaccine series within the past six months and would qualify for six month
<br> study visits or has received a third dose of the vaccine as standard of care.
<br>
<br> - Participants entering in the study at the six month study visit must have been on same
<br> treatment at their time of immunization.
<br>
<br> For Viral vector cohort:
<br>
<br> - Participant has a history of ulcerative colitis (UC) or Crohn's disease diagnosed by
<br> standard clinical, radiographic, endoscopic, and histopathologic criteria.
<br>
<br> - On one of the following treatment regimens:
<br>
<br> - Group A: Non-systemic immunosuppressive Group at least 15 participants
<br>
<br> - Mesalamine monotherapy or no therapy for IBD
<br>
<br> - Vedolizumab Therapy Group: on vedolizumab monotherapy
<br>
<br> - Group B: Systemic immunosuppressive Group at least 15 participants
<br>
<br> - Thiopurine Therapy Group: on azathioprine at least 2.0mg/kg or 6MP 1.0mg/kg
<br>
<br> - Anti-TNF Therapy Group: on maintenance therapy infliximab (at least 8 every
<br> 8 weeks), golimumab (at least monthly), adalimumab (at least every 2 weeks),
<br> or certolizumab (at least monthly)
<br>
<br> - Anti-TNF Combination Therapy Group: on anti-TNF therapy as described above
<br> along with either 15mg of methotrexate or azathioprine at least 1.0mg/kg or
<br> 6MP 0.5mg/kg
<br>
<br> - Ustekinumab Therapy Group: on either ustekinumab monotherapy or combination
<br> therapy with methotrexate or azathioprine.
<br>
<br> - Tofacitinib Therapy Group: on tofacitinib at least 5mg PO BID
<br>
<br> - Corticosteroid Therapy Group: on any one of the systemic immunosuppressive
<br> groups and any dose of corticosteroids
<br>
<br> - Participant has been on the same IBD treatment for at least two months.
<br>
<br> - Participant is receiving a viral vector COVID-19 vaccine per standard of care or has
<br> started or finished the viral vector series within the past 6 months. If participant
<br> entering at six months and would qualify for six month study visits and has received
<br> an additional one or two dose of viral vector of mRNA for a total of two -three COVID
<br> vaccines as standard of care.
<br>
<br> - Participants entering in the study at the six month study visit must have been on same
<br> treatment at their time of immunization.
<br>
<br> Exclusion Criteria:
<br>
<br> For mRNA cohort:
<br>
<br> - Allergy to COVID-19 vaccine or a component of it
<br>
<br> - Participant cannot or will not provide written informed consent
<br>
<br> - Unable to provide appropriate informed consent due to being illiterate or impairment
<br> in decision-making capacity
<br>
<br> For Viral vector cohort:
<br>
<br> - Allergy to COVID-19 vaccine or a component of it
<br>
<br> - Participant cannot or will not provide written informed consent.
<br>
<br> - Unable to provide appropriate informed consent due to being illiterate or impairment
<br> in decision-making capacity.
<br> | | IBD;Covid19 Vaccine | Diagnostic Test: Serological Assay for SARS-CoV-2 | Change in Geometric Mean Titers (GMT) of SARS-CoV-2 Antibody Concentrations following mRNA COVID-19 vaccine series;Sustained antibody concentrations of mRNA COVID-19 vaccines;Sustained antibody concentrations of mRNA COVID-19 vaccines;Change in level of T-cell response after mRNA COVID-19 vaccine;Percentage of participants with detectable level of T-cell response after mRNA COVID-19 vaccine→Percentage of participants with detectable level of T-cell response after mRNA COVID-19 vaccine;Change in level of T-cell response after mRNA COVID-19 vaccine;Sustained antibody concentrations of mRNA COVID-19 vaccines;Sustained antibody concentrations of mRNA COVID-19 vaccines;Change in Geometric Mean Titers (GMT) of SARS-CoV-2 Antibody Concentrations following mRNA COVID-19 vaccine series | | | | Yes | False | | |
| NCT04821934 | 11 October 2021 | Tele-rehabilitation Program After Hospitalization for COVID-19 | Efficacy of a Tele-rehabilitation Program After Hospitalization for COVID-19 Pneumonia: a Randomized Controlled Trial | | Istituti Clinici Scientifici Maugeri SpA | 26/03/2021 | 20210326 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04821934 | Recruiting | No | 18 Years | N/A | All | March 26, 2021 | 74 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Single (Outcomes Assessor). | N/A | Italy | | Mara Paneroni, PT | | mara.paneroni@icsmaugeri.it | +39 030 8253122 | |
<br> Inclusion Criteria:
<br>
<br> - One or both the following points:
<br>
<br> 1. need for 24-hour oxygen therapy to have a resting SpO2 of at least 94% or
<br> exercise-induced desaturation, defined as a reduction of at least 3% of SpO2 mean
<br> measured during the 6-minute test (6MWT) compared to SpO2 measured at rest
<br>
<br> 2. reduced tolerance to effort highlighted by the 6MWT with a value of the meters
<br> travelled less than 70 percent of the predicted one
<br>
<br> Exclusion Criteria:
<br>
<br> - Hemodynamic instability and the presence of uncontrolled cardiac arrhythmias
<br>
<br> - Any clinical condition that contraindicates aerobic exercise
<br>
<br> - Presence of motor disability before hospitalization which made it impossible to walk
<br> independently (Rankin scale> 3) (10)
<br>
<br> - Impaired cognitive status (Mini Mental State Examination test <24)
<br>
<br> - Inability to use (by the patient or a caregiver) the technological means sufficient to
<br> follow the program (mobile phone with internet connection)
<br>
<br> - Lack of supervision by a caregiver in case of walking and standing instability
<br> Contacts/Locations
<br> | | COVID-19 Pneumonia | Other: TR;Other: TSu | Change in 6 Minute Walking Test | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05067959 | 11 October 2021 | Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases | Covid-19 Vaccine Responses in Patients With Inflammatory Bowel Diseases | | Rabin Medical Center | 21/06/2021 | 20210621 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05067959 | Not recruiting | No | N/A | N/A | All | December 28, 2020 | 284 | Observational | | | Israel | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - 1. Adults >18 years of age 2. Patients with either Crohn's disease, ulcerative
<br> colitis, ileostomy, pouch 3. Not vaccinated to COVID-19 [i.e. before 2 mRNA Pfizer
<br> vaccines provided, or before any vaccine provided as one injection 4. Ability to
<br> attend follow up visits 5. Ability to understand and sign an informed consent form
<br>
<br> Exclusion Criteria:
<br>
<br> - 1. Pregnant women
<br> | | IBD;Covid19 | Biological: Covid-19 vaccine | vaccine efficacy in IBD population | | | | No | False | | |
| → | NCT05070624 | 11 October 2021 | The Peer Support Study | Connecting Caregivers During COVID-19: A Randomized Controlled Trial to Evaluate Virtual Peer-Support for Family Caregivers of Individuals With Neuromuscular Disease Using Home Mechanical Ventilation | | The Hospital for Sick Children | 27/09/2021 | 20210927 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05070624 | Not recruiting | No | N/A | N/A | All | October 15, 2021 | 100 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Health Services Research. Masking: None (Open Label). | N/A | | | Munazzah Ambreen, MD.,MSc | | munazzah.ambreen@sickkids.ca | 4164342542 | |
<br> Eligibility Criteria for Peer-Support Program:
<br>
<br> Inclusion Criteria
<br>
<br> 1. score of <10 on the Centre for Epidemiological Studies Short Depression (CESSD) scale
<br> during recruitment screening or score of = 10 with referral to psychiatry/ social work
<br> with= 1 session completed and ongoing monitoring19 (score of =10 is cutoff for
<br> positive depression screen);
<br>
<br> 2. FC of individual with NMD using HMV followed at 1 of the 8 HMV programs;
<br>
<br> 3. speaks and reads English;
<br>
<br> 4. currently using the aTouchAway™ App (Aetonix, Ottawa, Canada) in the LIVE program.
<br>
<br> Exclusion Criteria:
<br>
<br> We will exclude those Ventilator Assisted Individuals (VAI) and caregivers, who are:
<br>
<br> (1) Unable to communicate verbally in English
<br>
<br> Eligibility Criteria for Peer Mentors:
<br>
<br> Inclusion Criteria:
<br>
<br> 1. score of <10 on the Centre for Epidemiological Studies Short Depression (CESSD) scale;
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<br> 2. criteria 2-4 above;
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<br> 3. FC of an individual using HMV for = 5 years;
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<br> 4. completion of virtual peer support training;
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<br> 5. identified by the HMV team or self-referral.
<br>
<br> Exclusion Criteria:
<br>
<br> We will exclude those VAIs and caregivers, who are:
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<br> (1) Unable to communicate verballyin English
<br> | | Neuromuscular Diseases | Behavioral: The Virtual Peer Support Program | Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) at12 weeks;Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS)→Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS);Family Caregiver (FC) mastery measured using the Pearlin Mastery Scale (PMS) at12 weeks | | | | Yes | False | | |
| ACTRN12621000957897 | 11 October 2021 | The effect of light acupuncture and five-element music therapy for nurses’ mental health and wellbeing during and post COVID-19 | The experience and effects of light acupuncture and five-element music therapy for nurses’ mental health and wellbeing during and post COVID-19: a randomised crossover and feasibility study protocol | | Edith Cowan University | 22/07/2021 | 20210722 | ANZCTR | https://anzctr.org.au/ACTRN12621000957897.aspx | Not Recruiting | No | 18 Years | No limit | Both males and females | 30/11/2021 | 36 | Interventional | Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Crossover;Type of endpoint: Efficacy; | Not Applicable | Australia | | | | | | | Inclusion criteria: Participants are eligible for this study if they are registered nurses or enrolled nurses and working at least three shifts per week. | Exclusion criteria: People who have a fever or are highly sensitive to light, diagnosed with cancer, or pregnant women will not be eligible. | Mental health;Mental wellbeing ; <br>Mental health <br>Mental wellbeing ;Alternative and Complementary Medicine - Other alternative and complementary medicine;Mental Health - Anxiety;Mental Health - Depression | This is a crossover study with two weeks of intervention (3 sessions per week with six sessions in total) and a week washout period in between. Participants will receive a combination of light acupuncture and five-element music therapy from a licensed acupuncturist at the ECU Acupuncture Research Clinic. Each session will last 25-30 minutes, including preparation, treatment, and conclusion of treatment. The 3B Laser Pen (200mW) used in the intervention will have a wavelength of 808 nm in continuous wave mode to be applied to bare skin. Each pressure point will receive 20 seconds of energy (4J), with 20 minutes being the maximum treatment time (240 J). During the treatment, the participant will be listening to the five-element music (for the duration of the light therapy) depending on their emotional types (fear, anger, joy, anxiety, and sorrow). For example, if one has anger, frustration, and rage, it could indicate they have too much Yang energy or problems with Liver or detoxification pathways. They will follow the five-element diagram to listen to the Wood element music. Study-specific questionnaires and an observational sheet will be used throughout the trial process to monitor the adherence to the intervention. | The primary outcome for this study is the feasibility of the two-week light acupuncture and five-element music therapy for nurses working in WA hospitals. Feasibility will be assessed by measuring (1) recruitment and completion rates (No. of referred, No. of eligible, No. of enrolled, No. of withdrawals, trial recruitment rate, and trial completion rate); (2) treatment adherence (No. of completed sessions and missed sessions) and compliance; an observational sheet and study-specific questionnaires will be used throughout the trial process to monitor these outcomes; (3) a study-specific online survey will also qualitatively seek participants’ attitudes, motivation, and challenges to participation, reasons for withdrawal, missed sessions, and non-compliance with the intervention will be investigated via open-ended questions at the end of the trial. [Recruitment and completion rates will be assessed during the entire trial process. Treatment adherence and compliance will be assessed during the interventions. Online surveys will be administered at baseline (T0), post-two weeks intervention (T1), before the commencement of new intervention (following crossover) (T2), and post-two weeks intervention (T3).] | | | | Yes | False | | |
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| EUCTR2020-006003-42-DK | 8 October 2021 | Same as above | National Cohort Study of Effectiveness and Safety of SARS-CoV-2/Covid-19 vaccines (ENFORCE)
- ENFORCE | | CHIP - Rigshospitalet - University of Copenhagen | 21/12/2020 | 20201221 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-006003-42 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 30/12/2020 | 10000 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 4<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Denmark | Jens Lundgren | | Blegdamsvej 9 | jens.lundgren@regionh.dk | 453545 5757 | CHIP - Rigshospitalet, University of Copenhagen | Inclusion criteria: <br>1. Written informed consent obtained before any trial related procedures are performed<br>2. Male or female eligible for SARS-CoV-2 immunization (as defined by SST in the national vaccination plan) <br>3. The subject must be willing and able to comply with trial protocol (re-visits and biological samples)<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 5000<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 5000<br> | Exclusion criteria: <br>1. Male and female under the age of 18 <br>2. Any subgroup of individuals for which the vaccines are contra-indicated <br>3. Previous SARS-CoV-2 vaccination <br><br> | The aim is to study primarily effectiveness as well as safety of citizens being vaccinated with one of the SARS-CoV2 vaccines being applied in the Danish COVID-19 vaccine programme.
Whereas ongoing phase III trials are reporting vaccine efficacy in defined study populations, the effectiveness of these vaccines – and in particular the durability hereof - once introduced into the general population is presently unknown, and the focus of intense research and public health interest.
<br>MedDRA version: 23.1
Level: LLT
Classification code 10084465
Term: COVID-19 vaccination
System Organ Class: 100000004865
;Therapeutic area: Health Care [N] - Environment and Public Health [N06] | <br>Trade Name: COMIRNATY<br>concentrate for dispersion for injection COVID-19 mRNA Vaccine (nucleoside modified)<br>Pharmaceutical Form: Concentrate for solution for injection<br>INN or Proposed INN: COMIRNATY<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br>Trade Name: COVID-19 Vaccine Moderna dispersion for injection<br>COVID-19 mRNA Vaccine (nucleoside modified)<br>Pharmaceutical Form: Concentrate for solution for injection<br>INN or Proposed INN: COVID-19 Vaccine Moderna dispensation for injection<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br>Trade Name: COVID-19 Vaccine AstraZeneca suspension for injection<br>COVID-19 Vaccine (ChAdOx1-[recombinant])<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: COVID-19 Vaccine AstraZeneca suspension for injection<br>Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)<br>Concentration unit: ml millilitre(s)<br>Concentration type: equal<br>Concentration number: 0.5-<br><br>Trade Name: COVID-19 Vaccine Janssen suspension for injection<br>COVID-19 vaccine(AD26.CoV2-S [recombinant])<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: COVID-19 Vaccine Janssen<br>Other descriptive name: COVID-19 Vaccine Janssen (Ad26.COV2.S)<br>Concentration unit: ml millilitre(s)<br>Concentration type: equal<br>Concentration number: 0.5-<br><br> | Timepoint(s) of evaluation of this end point: MPNAT will be measured via profiling of antibodies against SARS-CoV-2 Spike epitopes performed at each visit until month 24.<br><br>The exact value of the MPNAT is currently not precisely defined, but is expected to be documented within short periods of time based on analyses across the ongoing phase III trials, associating titre levels with risk of breakthrough infection in the actively vaccinated group. <br><br>As the exact value of the MPNAT remains to be determined, and until that time point has arisen, a priori (i.e. while remaining blinded to the actually obtained data) of the actually defined cut-offs in neutralising titres that reasonable can serve as proxy for the MPNAT will be recommended by an expert advisory panel, and endorsed by the study leadership<br>;Primary end point(s): Primary outcome is the minimal protective neutralising antibody titre (MPNAT); i.e. the minimum level of neutralising antibodies sufficient to protect the person from becoming infected. <br> <br><br>;Secondary Objective: In relation to effectiveness, the following outcome will be compared between vaccine groups:<br>• Breakthrough infections throughout the 24 month follow-up period. <br>• A series of more detailed immunological assessment in subgroups of participants of markers of cellular immunity (see appendix 3)<br><br>In relation to safety, the following outcome will be compared between vaccine groups:<br>• Participants with local and systemic reactions to vaccination<br>• Grade 3 and 4 adverse events and serious adverse events. This will be ascertained and reported by study-affiliated staff. Primary safety outcomes are any grade 3 or 4 (i.e. serious) events observed within the first three months after the initial vaccination.<br>• Grade 1 and 2 events. This will be ascertained by study-affiliated staff as present on the specific day of Visit 2 and Visit 3.<br><br>;Main Objective: The primary objective of the study is to assess effectiveness of citizens being vaccinated with one of SARS-CoV2 vaccines the government has purchased, and the Danish Medicines Agency has approved for use in Denmark. The study will compare and predict the durability of the minimal protective titre afforded by each of the vaccines against COVID-19 through conducting comprehensive high-throughput SARS-CoV-2 antibody analyses and in-depth characterization of the vaccine-induced cellular immune response | | | | Yes | False | | |
| → | EUCTR2020-002345-42-FR | 8 October 2021 | A randomized, placebo controlled, double-blind, multi-center, phase II trial investigating the efficacy and safety of trimodulin (BT588) as add-on therapy to standard of care in adult subjects with severe COVID-19 | A randomized, placebo controlled, double-blind, multi-center, phase II trial investigating the efficacy and safety of trimodulin (BT588) as add-on therapy to standard of care in adult subjects with severe COVID-19 - ESsCOVID | | Biotest AG | 23/09/2020 | 20200923 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002345-42 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 16/12/2020 | 114 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Sweden;Russian Federation;Brazil;Spain;France | Clinical Trial Information | | Landsteinerstrasse 5 | patrick.langohr@biotest.com | | Biotest AG | Inclusion criteria: <br>1. Written informed consent obtained from the subject or legally authorized representative or informed verbal or administration consent due to pandemic situation, in compliance with all local legal requirements. <br>2. Male or female subject =18 years of age.<br>3. Laboratory-confirmed SARS-CoV-2 infection.<br>4. Diagnosis of community-acquired severe COVID-19 within 5 days after hospital-admission, with severe defined as:<br>o Need for non-invasive ventilation (NIV), or high-flow oxygen therapy (score =5 on the 9-category ordinal scale). <br>o At least one clinical respiratory parameter: <br>dyspnea, respiratory frequency =30/min, SpO2 =93%, 100 mmHg < PaO2/FiO2 =300 mmHg, lung infiltrates >50% within 24 to 48 hours.<br>o At least one measurement of C-reactive protein =50 mg/L within 18 hours prior to start of treatment.<br>5. Subject must receive SoC treatment for COVID-19.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 100<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 64<br> | Exclusion criteria: <br>2. Subjects that deteriorated to score >5 on the 9-category ordinal scale (e.g. receiving invasive mechanical ventilation (IMV), and/or extracorporeal membrane oxygenation (ECMO)) or subjects that improved to score <5 prior to randomization.<br>3. Severe neutropenia (neutrophil count <500/mm³) assessed within 18 hours prior to start of treatment.<br>4. Thrombocytopenia (platelet count <30,000/mm³) assessed within 18 hours prior to start of treatment.<br>5. Hemoglobin <7g/dL assessed within 18 hours prior to start of treatment.<br>6. Known hemolysis.<br>7. Known thrombosis or thromboembolic events (TEEs) or known medical history of TEEs (e.g. cerebrovascular accidents, transient ischemic attack, myocardial infarction, pulmonary embolism, and deep vein thrombosis) within the previous 3 months or those subjects particularly at risk for TEEs (e.g. history of thrombophilia, permanent immobilization, or permanent paralysis of the lower extremities) caused by other reasons than COVID-19.<br>8. Subject on dialysis or with severe renal impairment, estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m² assessed within 18 hours prior to start of treatment (details in Appendix 3: Estimated Glomerular Filtration Rate).<br>9. Subject with end stage renal disease (ESRD), or known primary focal segmental glomerulosclerosis (FSGS).<br>10. Known severe lung diseases interfering with COVID-19 therapy (e.g. severe interstitial lung disease, cystic fibrosis, idiopathic pulmonary fibrosis, active tuberculosis, chronically infected bronchiectasis, or active lung cancer).<br>11. Known decompensated heart failure (New York Heart Association class III–IV).<br>12. Known pre-existing hepatic cirrhosis, severe hepatic impairment (Child Pugh C score =9 points), or hepatocellular carcinoma.<br>13. Known intolerance to proteins of human origin or known allergic reactions to components of trimodulin.<br>15. Known treatment for thorax/head/neck/hematologic malignancies in the last 12 months.<br>17. Life expectancy of less than 90 days, according to the Investigator’s clinical judgment, because of medical conditions neither related to COVID-19 nor to associated medical complications.<br>18. Obesity (body mass index =40 kg/m²), a body weight of more than 123 kg, or anorexia (body mass index <16 kg/m²).<br><br> | Severe Corona Virus Disease 2019 (COVID-19) <br>MedDRA version: 23.0
Level: PT
Classification code 10084380
Term: COVID-19 pneumonia
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: trimodulin <br>Product Code: BT588<br>Pharmaceutical Form: Solution for infusion<br>INN or Proposed INN: Trimodulin (human IgM, IgA, IgG solution)<br>Current Sponsor code: BT588<br>Other descriptive name: IgM Concentrate<br>Concentration unit: g/ml gram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 0.05-<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br> | Timepoint(s) of evaluation of this end point: Included in E.5.1<br>Clinical deterioration rate (score =6-7) between day 6 and day 29<br>28-day all-cause mortality rate (score =8) between day 1 and day 29;Primary end point(s): The composite endpoint is evaluated on day 29 [+3]<br><br>;Secondary Objective: Pharmacodynamic (PD) and pharmacokinetic (PK) properties of trimodulin will be evaluated in all subjects.;Main Objective: The objectives of the trial are to evaluate the efficacy and safety of trimodulin as add-on therapy to standard of care (SoC) compared to placebo treatment in adult hospitalized subjects with severe COVID-19. →Main Objective: The objectives of the trial are to evaluate the efficacy and safety of trimodulin as add-on therapy to standard of care (SoC) compared to placebo treatment in adult hospitalized subjects with severe COVID-19. ;Timepoint(s) of evaluation of this end point: Included in E.5.1<br>Clinical deterioration rate (score =6-7) between day 6 and day 29<br>28-day all-cause mortality rate (score =8) between day 1 and day 29;Primary end point(s): The composite endpoint is evaluated on day 29 [+3]<br><br>;Secondary Objective: Pharmacodynamic (PD) and pharmacokinetic (PK) properties of trimodulin will be evaluated in all subjects. | | | | Yes | False | | |
| EUCTR2020-005526-29-FR | 8 October 2021 | A randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infection. | ODYSSEY: A randomized, double-blind, placebo-controlled study to investigate the efficacy of tradipitant in treating inflammatory lung injury and improving clinical outcomes associated with severe COVID-19 infection - ODYSSEY | | Vanda Pharmaceuticals Inc. | 29/01/2021 | 20210129 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005526-29 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 31/03/2021 | 300 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| France;United States | Christoph Wachter | | Immeuble Le Patio – Regus 35/37 Rue Louis Guérin | christoph.wachter@expertrials.com | 4369910414754 | Expertrials | Inclusion criteria: <br>1. Adults aged 18-90;<br>2. Confirmed laboratory COVID-19 infection;<br>3. Confirmed pneumonia by chest radiograph or computed tomography;<br>4. Fever defined as temperature = 36.6 °C armpit, = 37.2 °C oral, or = 37.8 °C rectal since admission or the use of antipyretics;<br>5. PaO2 / FiO2 = 300;<br>6. In-patient hospitalization.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 300<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 300<br> | Exclusion criteria: <br>1. Inability to provide informed consent or to have an authorized relative or designated person provide informed consent, or to comply with the protocol requirements;<br>2. Known allergy to tradipitant or other neurokinin-1 antagonists;<br>3. Pregnancy;<br>4. Uncontrolled HIV, HBV, or HCV infection;<br>5. Other uncontrolled medically significant diseases;<br>6. Enrollment in another clinical trial of an investigational therapy;<br>7. Alanine aminotransferase > 5X Upper Limit of Normal or Creatinine clearance < 50 ml / min;<br>8. Requiring mechanical ventilation for > 72 hours.<br> | inflammatory lung injury associated with severe COVID-19 infection <br>MedDRA version: 23.1
Level: LLT
Classification code 10084383
Term: Novel COVID-19-infected pneumonia
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: tradipitant<br>Product Code: VLY-686<br>Pharmaceutical Form: Capsule, hard<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br> | Primary end point(s): The primary endpoint is the percentage of responders at day 28, as defined by an improvement of 2 or more points on a clinical status 7-point scale as compared to baseline. The primary endpoint will be summarized in Kaplan-Meier survival curve, and the treatment difference will be tested by the log-rank test in the ITT population.<br>The statistical analyses will be detailed in the statistical analysis plan (SAP).;Secondary Objective: 1. Time to response on 7-point ordinal scale<br>2. Time to normalization of fever for at least 48 hours<br>3. Time to improvement in oxygenation for at least 48 hours<br>4. Treatment and prevention of inflammatory lung injury as measured by inflammatory markers<br>5. Rate of Decline of COVID-19 viral load assessed by RT-PCR from nasopharyngeal samples<br>6. In-hospital mortality<br>7. Mean change in NEWS2 score from baseline<br>8. Understand the effect of genetics for treatment response, and understand genetics of COVID-19 virus<br>9. Reduction from baseline of NRS for cough<br>10. Reduction from baseline of NRS for nausea<br>11. Length of hospital stay;Main Objective: To evaluate the effect of tradipitant in COVID-19 participants, as measured by the percentage of responders with an improvement of 2 or more points on a 7-point ordinal scale as compared to baseline.<br>The 7-point ordinal scale is defined as follows:<br>1- Death<br>2- Hospitalized on mechanical ventilation or ECMO<br>3- Hospitalized on non-invasive ventilation or high-flow oxygen supplementation<br>4- Hospitalized requiring supplemental oxygen<br>5- Hospitalized not requiring supplemental oxygen, requiring continued medical care<br>6- Hospitalized not requiring supplemental oxygen, not requiring continued medical care<br>7- Not hospitalized;Timepoint(s) of evaluation of this end point: Day 28 | | | | Yes | False | | |
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| EUCTR2021-000988-68-SE | 8 October 2021 | Immune response after covid-19 vaccination in patients with renal failure stadium 4 or 5 . | Immune response after covid-19 vaccination in patients with renal failure stadium 4 or 5 . - RenalCoV | | Region Stockholm | 08/03/2021 | 20210308 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000988-68 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 31/03/2021 | 60 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Sweden | Infektionskliniken | | Universitetssjukhuset Örebro | anja.rosdahl@regionorebrolan.se | +460196021000 | Region Örebro län | Inclusion criteria: <br>- Adult 18-65 years old. <br>- Chronic renal failure stadium 4 or 5 with or without dialysis. <br>- The study patient has given her/his consent to participate in the study.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 50<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 10<br> | Exclusion criteria: <br>- Previous renal transplantation <br>- Concomitant medication with immune-modulating agent<br>- Current or previous known covid-19 infection at inclusion (i.e previous PCR positive for SARS-CoV-2 or previous detection of SARS-CoV-s antibodies).<br>Antibodies detected during screening for this study is not an exclusion criterion. <br>- Information in the Health declaration for covid-19 vaccination (17) which suggests that vaccination is inappropriate.<br>- Vaccinated or planned vaccination with other vaccine within the next 14 days that can not be rescheduled.<br>- Pregnancy<br>- Hypersensitivity for any substance in the vaccine<br>- Mental impairment, reluctance to participate or language difficulties which entail difficulties to understand the implication of the study <br>- Individual who is not considered appropriate for study participation due to any other reason. <br> | Renal failure stage 4 and 5.;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Trade Name: COVID-19 Vaccine AstraZeneca<br>Product Name: COVID-19 Vaccine AstraZeneca<br>Pharmaceutical Form: Suspension for injection<br><br>Trade Name: Comirnaty<br>Product Name: Comirnaty<br>Pharmaceutical Form: Concentrate for solution for injection<br><br>Trade Name: COVID-19 Vaccine Moderna - Spikevax<br>Product Name: COVID-19 Vaccine Moderna - SpikeVax<br>Pharmaceutical Form: Dispersion for injection<br><br> | Timepoint(s) of evaluation of this end point: Before vaccination (screening visit), Visit 2 (dose 2), Visit 3 (+14 days from dose 2)<br>See table 1 in the study protocol. ;Primary end point(s): SARS-CoV-2 IgG directed towards the spike protein in blood collected before the vaccination and 2 weeks after the second vaccine dose. The analysis will be performed by ELISA.;Secondary Objective: - What proportion of patients with chronic renal failure stadium 4 or 5, with or without dialysis, have remaining immunity, i.e. continual detection of antibodies towards SARS-CoV-2, 3, 6 and 12 months after the second vaccine dose. <br><br>-Difference in immune response before and two weeks after an extra dose, if relevant<br><br>- How common are side effects for covid-vaccination and what side effects occurs (AE/SAE/SUSAR);Main Objective: To investigate the proportion of patients with renal failure stadium 4 and 5, with or without dialysis, who have seroconverted 2 weeks after vaccine dose 2 or have at least 10^2 increase of neutralizing antibodies towards SARS-CoV-2 compared with baseline. | | | | Yes | False | | |
| → | EUCTR2021-000683-30-SE | 8 October 2021 | CoVacc - Immune response to vaccination against Covid-19 | CoVacc - Immune response to vaccination against Covid-19, an open multicenter phase IV study | | Umeå university | 23/02/2021 | 20210223 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000683-30 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 03/03/2021 | 3000 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Sweden | Clas Ahlm | | Department of Clinical Microbiology, University hospital | clas.ahlm@umu.se | | Umeå university | Inclusion criteria: <br>• Consents to participate in the study<br>• Age = 18 years<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 2250<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 750<br> | Exclusion criteria: <br>• Age <18 years<br>• Incapable of giving informed consent (does not apply to participants in the elderly study)<br>• Contraindication to vaccination<br>• Severe disease (assessed to affect the subjects ability to complete the study)<br>• Ongoing treatment that is judged to affect the vaccine response (Does not include inhaled steroids and nasal sprays, as well as tablet cortisone =15mg / day. Rituximab treatment is not an exclusion criterion.)<br>Participants in the elderly study:<br>The exclusion criteria described in the protocol above for CoVacc will not apply to the sub-study called The Elderly Study, this clinical research study in which people with severe illness and people who lack their own decision-making ability can be included. Data on chronic diseases or drugs will not be collected<br><br> | Individuals with and without pre-existing immunity to Covid-19.;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Trade Name: Covid-19 vaccine, all vaccines with marketing authorisation in Sweden are allowed.<br>Product Name: Covid-19 vaccine<br>Product Code: NA<br>Pharmaceutical Form: Concentrate and solvent for solution for injection<br><br> | Main Objective: Does antibody development to SARS-CoV-2 S protein differ after vaccination between those who have had a previous SARS-CoV-2 infection compared to Covid-19 naive individuals?;Primary end point(s): Investigate the level of specific antibodies to SARS-CoV-2 yearly, up to four years after vaccination.;Timepoint(s) of evaluation of this end point: 1, 2, 3, 4 year after vaccination;Secondary Objective: Better understanding of how the human immune system reacts when exposed to foreign protein antigen measured as antibody level in serum, plasma and mucosa as well as at the cellular and genetic level.<br>The secondary issues are those that are general to understanding how the human immune system works in both infection and vaccination.→Secondary Objective: Better understanding of how the human immune system reacts when exposed to foreign protein antigen measured as antibody level in serum, plasma and mucosa as well as at the cellular and genetic level.<br>The secondary issues are those that are general to understanding how the human immune system works in both infection and vaccination.;Timepoint(s) of evaluation of this end point: 1, 2, 3, 4 year after vaccination;Primary end point(s): Investigate the level of specific antibodies to SARS-CoV-2 yearly, up to four years after vaccination.;Main Objective: Does antibody development to SARS-CoV-2 S protein differ after vaccination between those who have had a previous SARS-CoV-2 infection compared to Covid-19 naive individuals? | | | | Yes | False | | |
| EUCTR2021-000413-17-SE | 8 October 2021 | COVERS (COVID-Vaccination Efficiency Risk and Safety Study) | COVERS (COVID-Vaccination Efficiency Risk and Safety Study)
- an open trial for follow-up of efficacy, risk and safety in persons who have been vaccinated against SARS-CoV-2 in Region Skåne with vaccines approved in Sweden | | Region Skåne - Kliniska Studier Sverige, Forum Söder | 15/02/2021 | 20210215 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000413-17 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 24/02/2021 | 4000 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Sweden | Ulf Malmqvist | | Akutgatan 8 | ulf.malmqvist@skane.se | | Kliniska Studier Sverige, Forum Söder | Inclusion criteria: <br>1. To be included, the person must have received the COVID-19 vaccine.<br>2. To be included, the person must, in addition to vaccination against COVID-19, also have<br>a) signed by EPM approved participant information<br>b) reached the age of 18.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 3000<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 1000<br> | Exclusion criteria: <br>Subjects below the age of 18 are excluded<br> | Coronavirus disease 2019 (COVID-19);Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Pharmaceutical Form: <br><br> | Timepoint(s) of evaluation of this end point: The serology against COVID-19 will be evaluated in conjunction to the vaccination and 1, 6, 12 och 24 monts after. ;Primary end point(s): Serology against COVID-19;Secondary Objective: • Immune response in people with a history of covid-19 infection.<br>• Immune response after the first dose<br>• Immune response after the second dose (for vaccines given with two doses)<br>• Difference in immune response between different vaccine types<br>• Immune response in subpopulations (e.g. elderly (70+) and gender)<br>• Immune response in those who have undergone covid-19 infection without developing antibodies<br>• Immune response over time;Main Objective: Comparative effect over time on the immune response of approved COVID-19 vaccines used in mass vaccination in Sweden | | | | Yes | False | | |
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| ISRCTN51124684 | 11 October 2021 | Can drinking beetroot juice prevent and reduce the severity of winter viral infections in residential and nursing homes? | Nitric oxide for preventing and reducing the severity of winter viral infections in care (residential and nursing) homes (BEET-Winter) | | University of Nottingham | 13/01/2021 | 20210113 | ISRCTN | https://www.isrctn.com/ISRCTN51124684 | Recruiting | No | | | Both | 01/05/2021 | 416 | Interventional | Prospective phase II cluster-randomized double-blind placebo-controlled trial assessing feasibility and proof of principle (Prevention) | Not Applicable | United Kingdom;England | Diane | Havard |
A07, Clinical Sciences Building
City Hospital Campus
Hucknall Road
| diane.havard@nottingham.ac.uk | +44 (0)115 823 1775 | | Inclusion criteria: <br> 1. Residents from 26 participating care homes (residential and nursing) with 16 participants from each<br> 2. Aged =65 years<br> 3. Currently consuming a normal diet<br> 4. Willing to take treatment having taste-tested a beetroot shot<br> | Exclusion criteria: <br> 1. Unwilling to participate or opted-out of the trial (resident, or family, if resident lacks capacity)<br> 2. Currently consuming a soft diet or using a thickener<br> 3. Using antiseptic mouthwash<br> 4. Identified by care home staff to be in the last few days of life<br> 5. Short-term respite care<br> 6. Care home staff<br> | Winter respiratory viral infections in care home residents <br>Respiratory | <br> Homes, and not participants, will be randomised. Randomisation will be stratified by care home type (residential vs nursing/mixed), prior COVID-19 in phase 1 of pandemic (yes vs no), and size of care home (number of residents <32 vs >32). Residents and care home staff are blinded, with a double-blind design.<br><br> Participants will be randomly allocated to receive either:<br> 1. Nitric Oxide in the form of 70 ml of beetroot juice containing 400 mg nitrate given once daily for 60 days<br> 2. Placebo in the form of 70 ml of beetroot juice containing 0 mg nitrate given once daily for 60 days<br><br> The intervention and placebo are foods and not investigational products. Active beetroot juice is available from supermarkets and on-line.<br><br> Participants will be invited for three follow-up visits. The first follow up visit will occur on day 14, where saliva/urine nitrate/nitrite test, dietary nitrate intake from menu, and beetroot juice adherence will be assessed. The second follow up visit will be on day 60, where the clinical tests Clinical Frailty Index (CFI), Barthel index (BI), 6 item cognitive impairment test (6CIT), quality of life visual analogue scale (EQ-VAS), and EuroQol 5-dimension 5-level (EQ-5D-5L) quality of life questionnaire, as well as dietary nitrate intake from menu and saliva/urine nitrate/nitrite test will be assessed. The final follow up visit will be on day 90 where saliva/urine nitrate/nitrite test and dietary nitrate intake from menu will be assessed.<br> | <br> 1. Feasibility of conducting a larger scale trial assessed using data on the recruitment of care homes, recruitment of residents, assessment of background infection rate, assessment of background dietary nitrate intake, adherence to the intervention, ability to measure the ordinal outcome, an estimation of the intra-cluster correlation (ICC), and incidence of death between baseline and 60 days<br> 2. Severity of the first infection measured using a 5 level ordinal outcome (using the worst level if >1 event, where a score of: 0 represents no symptoms of infection; 1 represents symptoms of infection; 2 represents symptoms of infection needing healthcare advice such as a call to 111, or GP appointment; 3 represents hospitalisation for any reason, or intention to hospitalise but advance directive precluded this; or 4 represents death from any cause) between baseline and 60 days<br> | | 31/08/2022 | | Yes | False | | |
| → | ISRCTN53038326 | 11 October 2021 | IMU838 and oseltamivir in the treatment of COVID-19 | Prospective, randomized, parallel-group, open-label study to evaluate the efficacy and safety of IMU-838, in combination with oseltamivir, in adults with coronavirus disease COVID-19 | | University Hospitals Coventry and Warwickshire NHS Trust | 23/09/2020 | 20200923 | ISRCTN | https://www.isrctn.com/ISRCTN53038326 | Recruiting | No | | | Both | 22/06/2020 | 120 | Interventional | Randomized; Interventional; Design type: Treatment, Drug (Treatment) | Phase II | England;United Kingdom→United Kingdom;England | | | | | | | Inclusion criteria: <br> 1. Male or non-pregnant female patients at least 18 years old<br> 2. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection<br> 2.1. Confirmed cases: prospective participants who test positive to a validated specific SARS-CoV-2 nucleic acid test or has the virus identified by electron microscopy or viral culture, as per local trust policy <= 5 days before randomization<br> 2.2. Probable/Suspected case: prospective participants who have been in contact with a confirmed case of COVID-19, AND has mild to severe Covid-19 clinical symptoms AND radiographic evidence* of pulmonary infiltrates consistent with COVID-19 disease<br> 3. Moderate to severe COVID-19 requiring hospitalisation defined as:<br> 3.1. Clinical status category 3-5 (inclusive) on the 7-point clinical status category scale as proposed by the World Health Organisation (WHO) master protocol:<br> I. Category 3: hospitalized, no oxygen therapy<br> II. Category 4: hospitalized, oxygen by mask or nasal prongs<br> III. Category 5: hospitalized, non-invasive ventilation or high-flow oxygen<br> *where routinely available, no tests will be requested for research purpose<br> | Exclusion criteria: <br> 1. General exclusion criteria:<br> 1.1. Allergic or hypersensitivity to the IMU-838, oseltamivir, or any of the ingredients<br> 1.2. Pregnant or breastfeeding or with the intention to become pregnant during the study<br> 1.3. Participants who cannot take trial medication orally<br> 2. Concomitant medication or medical history:<br> 2.1. If the attending clinician believes that there is a specific contraindication to the IONIC intervention (see Appendix 3; section 9.1.2 in protocol)<br> 2.2. Patient has a medical or concomitant disease history preventing him to participate ( for further information please see; Appendix 3 in protocol)<br> 3. COVID-19 related exclusion criteria:<br> 3.1. Participation in any other interventional clinical trial for an experimental treatment for COVID-19<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> This study comprises of a screening period, a 14-day treatment period, and up to a 14-day follow-up period evaluating the efficacy of the IONIC intervention in comparison to oseltamivir alone. All participants will receive standard care in addition to the IONIC intervention or oseltamivir, consistent with WHO recommendations.<br><br> As this is a Phase 2b trial, clinical improvement (based on the 7-point ordinal scale) is considered an acceptable outcome measurement in line with the WHO’s recommendations on research and development for COVID-19.1 The WHO also recommends assessing mortality, which is a secondary endpoint in the present trial.<br><br> The lead site of the study is University Hospital Coventry and Warwickshire NHS Trust. The study will be initiated as a single-centre trial, however, depending upon recruitment rate as well as the information gathered from the interim analysis, the study may include other NHS trusts interested in participating.<br><br> Study groups:<br> 1. Control group: oseltamivir 75 mg BID and standard care<br> 2. Interventional group: IMU-838 (22.5 mg BID) plus oseltamivir 75 mg BID and standard care (IONIC intervention)<br><br> All patients will receive standard care as necessary (e.g. supplemental oxygen, non-invasive and invasive ventilation, antibiotic agents, vasopressor support and renal-replacement therapy) as required and determined by local practice. After Day 14, all patients will continue with appropriate standard care as decided by the clinical care team.<br><br> Patient identification/screening<br> Patients who have been either diagnosed or awaiting test for COVID-19 will be briefly informed about the study. They will be offered | Time-to-clinical improvement; defined as the time from randomization to a 2-point improvement on a 7-point ordinal scale, or discharge from hospital or death (whichever occurs first). A clinically significant difference is defined as a difference of at least a 2-point improvement on the WHO ordinal scale; Timepoint(s): 14 days after randomization | | 30/06/2023 | | No | False | | |
| ISRCTN60033461 | 11 October 2021 | Neonatal complications of coronavirus disease (COVID-19) study | Neonatal complications of coronavirus disease (COVID-19) study | | University of Oxford | 31/07/2020 | 20200731 | ISRCTN | https://www.isrctn.com/ISRCTN60033461 | Recruiting | No | | | Both | 01/03/2020 | 10000 | Observational | Observational national prospective cohort study (Other) | Not Applicable | United Kingdom;England | | | | | | | Inclusion criteria: <br> Two groups of babies are eligible for inclusion:<br> 1. Babies who have a diagnosis of SARS-CoV-2 infection made on a sample taken in the first 28 days and received inpatient care on a postnatal ward, neonatal unit, paediatric inpatient ward or paediatric intensive care unit<br> 2. Babies born to mothers with COVID-19 where the baby requires hospital care within the first 28 days after birth<br> | Exclusion criteria: Does not meet inclusion criteria | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | Observational study: using the British Paediatric Surveillance Unit system we will collect information about presentation, mode of transmission, severity, management and outcomes for hospitalised neonates diagnosed with SARS-CoV-2 and the same information for babies born to mothers with COVID-19 disease from 1st March 2020 until 31st March 2021. | Incidence of neonatal COVID-19 and mode of transmission measured using patient records from the British Paediatric Surveillance Unit system from 1st March 2020 until 31st March 2021 | | 30/09/2022 | | No | False | | |
| --- | PER-048-20 | 12 October 2021 |
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO ASSESS THE EFFICACY AND
SAFETY OF AD26.COV2.S FOR THE PREVENTION OF SARS-COV-2-MEDIATED COVID-19 IN ADULTS
AGED 18 YEARS AND OLDER
|
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED PHASE 3 STUDY TO ASSESS THE EFFICACY AND
SAFETY OF AD26.COV2.S FOR THE PREVENTION OF SARS-COV-2-MEDIATED COVID-19 IN ADULTS
AGED 18 YEARS AND OLDER
| | Janssen Vaccines & Prevention B.V., | 28/09/2020 | 20200928 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=048-20 | Not Recruiting | No | | | | 04/09/2020 | 2000 | Interventional | <br> This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3, pivotal efficacy and<br> safety study in adults ≥18 to <60 years of age and ≥60 years of age. The efficacy, safety, and<br> immunogenicity of Ad26.COV2.S will be evaluated in participants living in, or going to, locations<br> with high risk for acquisition of SARS-CoV-2 infection after administration of study vaccine.<br> The study will consist of a screening phase of up to 28 days, a 52-week double-blind study period<br> (including the administration of 1 dose of study vaccine [on Day 1], after randomization), and a<br> long-term follow-up period of 1 additional year. The duration of individual participation, including<br> screening, will be maximum 2 years and 1 month. If a participant is unable to complete the study,<br> but has not withdrawn consent, an early exit visit will be conducted. The end-of-study is considered<br> as the completion of the last v | III | United States;Peru;Mexico;Colombia;Chile;Canada;Brazil;Argentina;South Africa;Philippines | Paul | Toralva | AV. REPUBLICA DE PANAMA Nro. 3533, Int. 1404, Limatambo, San Isidro | paul.toralva@quintiles.com | 51999484207 | IQVIA RDS Peru S.R.L | Inclusion criteria:
<br> Each potential participant must satisfy all of the following criteria to be enrolled in the study:
<br> 1. Participants (or their legally acceptable representative based on local regulations) must
<br> provide consent indicating that he or she understands the purpose, procedures and potential
<br> risks and benefits of the study, and is willing to participate in the study.
<br> 2. Participant is willing and able to adhere to the prohibitions and restrictions specified in this
<br> protocol.
<br> 3. Stages 1a and 1b: Participant is ≥18 to <60 years of age on the day of signing the ICF.
<br> As of Stages 2a and 2b: Participant is ≥60 years of age on the day of signing the ICF.
<br> 4. Stages 1a and 2a: In the investigator’s clinical judgement, participant must be either in good
<br> or stable health, including a BMI <30 kg/m2.Participants may have underlying illnesses (not associated with increased risk of progression to severe COVID-19a, as specified in Exclusion Criteria 15), as long as their symptoms and signs are stable and well-controlled. If participants are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and
<br> expected to remain stable for the duration of the study. Participants will be included on the
<br> basis of relevant medical history and height and weight measurement at screening.
<br> As of Stages 1b and 2b: In the investigator’s clinical judgement, participant may have a stable
<br> and well-controlled comorbidity associated with an increased risk of progression to severe
<br> COVID-19 (eg, stable/well-controlled HIV infection*). If participants are on medication for a condition, the medication dose must have been stable for at least 12 weeks preceding vaccination and expected to remain stable for the duration of the study. Participants will be included on the basis of relevant medical history and height and weight measurement at screening.
<br> ** Stable/well-controlled HIV infection includes:
<br> a. CD4 cell count ≥300 cells/µL. b. HIV viral load <50 vp/mL. c. Participant must be on a stable anti-retroviral treatment (ART) for 6 months (unless the change is due to tolerability, in which case the regimen can be for only the previous 3 months; changes in formulation are allowed) and the participant
<br> must be willing to continue his/her ART throughout the study as directed by his/her local physician.
<br> Note: Participants with ongoing and progressive comorbidities associated with HIV infection will be excluded but comorbidities associated with HIV infection that have been clinically stable for the past 6 months are not an exclusion criterion.
<br> Laboratory methods for confirming a diagnosis of HIV infection are: Any evidence(historic or current) from medical records, such as ELISA with confirmation with Western Blot or PCR, or of a detectable viral load (country-specific regulatory approved tests). A laboratory result within 6 months of screening does not need to be repeated.
<br> If a potential participant does not have the HIV viral load and CD4 cell count in his/her
<br> medical records, they will be instructed to go to their local health care provider and
<br> obtain the necessary data for potential entry into the trial
<br> 5. Contraceptive (birth control) use should be consistent with local regulations regarding the
<br> acceptable methods of contraception for those participating in clinical studies.
<br> Before ra | Exclusion criteria:
<br> Any potential participant who meets any of the following criteria will be excluded from
<br> participating in the study:
<br> 1. Participant has a clinically significant acute illness (this does not include minor illnesses such
<br> as diarrhea or mild upper respiratory tract infection) or temperature ≥38.0ºC (100.4°F) within
<br> 24 hours prior to the planned study vaccination; randomization at a later date is permitted at
<br> the discretion of the investigator and after consultation with the sponsor.
<br> 2. Participant has a known or suspected allergy or history of anaphylaxis or other serious adverse
<br> reactions to vaccines or their excipients (including specifically the excipients of the study
<br> vaccine; refer to the IB).
<br> 3. Participant has abnormal function of the immune system resulting from:
<br> a. Clinical conditions (eg, autoimmune disease, potential immune mediated disease or
<br> known or suspected immunodeficiency, chronic kidney disease [with dialysis]) expected
<br> to have an impact on the immune response of the study vaccine. Participants with clinical
<br> conditions stable under non-immunomodulator treatment (eg, autoimmune thyroiditis,
<br> autoimmune inflammatory rheumatic disease such as rheumatoid arthritis) may be
<br> enrolled at the discretion of the investigator. Non-immunomodulator treatment is allowed
<br> as well as steroids at a non-immunosuppressive dose or route of administration.
<br> b. Chronic (>10 days) or recurrent use of systemic corticosteroids within 6 months before
<br> administration of study vaccine and during the study. A substantially immunosuppressive
<br> steroid dose is considered to be ≥2 weeks of daily receipt of 20 mg/kg body weight of
<br> prednisone or equivalent.
<br> Note: Ocular, topical or inhaled steroids are allowed.
<br> c. Administration of antineoplastic and immunomodulating agents or radiotherapy within
<br> 6 months before administration of study vaccine and during the study.4. Participant received treatment with Ig in the 3 months or blood products in the 4 months before
<br> the planned administration of the study vaccine or has any plans to receive such treatment
<br> during the study.
<br> 5. Participant received or plans to receive:
<br> a. Licensed live attenuated vaccines - within 28 days before or after planned administration
<br> of study vaccine.
<br> b. Other licensed (not live) vaccines - within 14 days before or after planned administration
<br> of study vaccine.
<br> 6. Participant previously received a coronavirus vaccine.
<br> 7. Participant received an investigational drug (including investigational drugs for prophylaxis
<br> of COVID-19) or used an invasive investigational medical device within 30 days or received
<br> an investigational vaccine (including investigational Adenoviral-vectored vaccines) within
<br> 6 months before the planned administration of the study vaccine or is currently enrolled or
<br> plans to participate in another investigational study during the course of this study. See also
<br> Section 6.8.
<br> Note: Participation in an observational clinical study is allowed at the investigator’s
<br> discretion; please notify the sponsor (or medical monitor) of this decision.
<br> 8. Participant is pregnant, or planning to become pregnant while enrolled in this
<br> study or within 3 months after study vaccine.
<br> 9. Participant has a history of an underlying clinically significant acute or chronic medical
|
-J98
-D818 Other combined immunodeficiencies
<br>Other combined immunodeficiencies;D818;J98 ;Other combined immunodeficiencies | <br> Group name:GROUP 1:AD26.COV2.S (5 × 1010 PV) INJ IM Type of group;1 N° of participants:3000 Intervention(s) description:This is a multicenter, randomized, double-blind, placebo-controlled, Phase 3, pivotal efficacy and safety<br> study in adults ≥18 to <60 years of age and ≥60 years of age. The efficacy, safety, and immunogenicity of<br> Ad26.COV2.S will be evaluated in participants living in, or going to, locations with high risk for acquisition<br> of SARS-CoV-2 infection after administration of study vaccine.<br> Participants will be randomized in parallel in a 1:1 ratio to receive intramuscular (IM) injections of<br> Ad26.COV2.S or placebo as shown in the table below. Ad26.COV2.S will be administered at a dose level<br> of 1×1011 virus particles (vp).<br> Table: Vaccination Schedule VAC31518COV3001<br> Group N Day 1<br> 1 Up to 30,000 Ad26.COV2.S (5×1010 vp)<br> 2 Up to 30,000 Placebo<br> N = number of participants; vp = virus particles.<br> Note: It is intended that a minimum of approximately 25% of recruited participants will be ≥60 years of age<br> Group name:GROUP PLACEBO FOR AD26.COV2.S (5 × 1010 PV) INJ IM Type of group;2 N° of participants:3000 Intervention(s) description:GROUP PLACEBO FOR AD26.COV2.S (5 × 1010 PV) INJ IM<br><br> Table: Vaccination Schedule VAC31518COV3001<br> Group N Day 1<br> 1 Up to 30,000 Ad26.COV2.S (5×1010 vp)<br> 2 Up to 30,000 Placebo<br> N = number of participants; vp = virus particles.<br> Note: It is intended that a minimum of approximately 25% of recruited participants will be ≥60 years of age<br> | <br> Outcome name:Molecular confirmation (RT-PCR)<br> Measure:First occurrence of molecularly confirmed, moderate to severe/critical COVID-19, with onset at least 28 days post-vaccination<br> Timepoints:28 days post-vaccination<br> | | | | No | False | | |
| EUCTR2020-001591-15-NL | 12 October 2021 | Reducing hospital admission of elderly in Coronavirus pandemic by boosting the immune system through vaccination with bacillus Calmette-Guérin (BCG). | Reducing hospital admission of elderly in SARS-CoV-2 pandemic via the induction of trained immunity by bacillus Calmette-Guérin vaccination, a randomized controlled trial. - BCG-CORONA-ELDERLY | | Radboudumc | 06/04/2020 | 20200406 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001591-15 | Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 09/04/2020 | 2000 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: yes<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Netherlands | Jaap ten Oever | | Geert Grooteplein-Zuid 8 | jaap.tenoever@radboudumc.nl | 0310243617257 | Radboudumc | Inclusion criteria: <br>In order to be eligible to participate in this study, a subject must meet the following criteria:<br>• Adult (= 60 years) <br>• Written informed consent<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 800<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 1200<br> | Exclusion criteria: <br>• Fever (>38 ºC) within the past 24 hours <br>• Suspicion of current active viral or bacterial infection <br>• Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks <br>• Active solid or non-solid malignancy or lymphoma within the prior two years<br>• Active participation in another research study that involves BCG administration<br><br> | SARS-CoV-2 infection <br>MedDRA version: 20.0
Level: HLT
Classification code 10047490
Term: Virus identification and serology
System Organ Class: 100000004848
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: BCG vaccine (BCG-Vaccin SSI [Nederlands VaccinStatens Serum Instituut]) Danish strain 1331.<br>Pharmaceutical Form: Concentrate and solvent for solution for injection<br>Pharmaceutical form of the placebo: Solution for injection<br>Route of administration of the placebo: Intradermal use<br><br> | Timepoint(s) of evaluation of this end point: Between day 0 up to 12 months after inclusion;Primary end point(s): SARS-CoV-2 related hospital admission;Secondary Objective: To reduce SARS-CoV-2 related symptoms, the duraction of hospital admission or death of elderly people during the SARS-CoV-2 outbreak.;Main Objective: To reduce hospital admission of elderly people during the SARS-CoV-2 outbreak. | | | | Yes | True | parent | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04358081 | 18 October 2021 | Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease | A Multi-center, Randomized, Double-blinded, Placebo-controlled Study to Evaluate the Safety and Efficacy of Hydroxychloroquine Monotherapy and in Combination With Azithromycin in Patients With Moderate and Severe COVID-19 Disease | | Novartis Pharmaceuticals | 08/04/2020 | 20200408 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04358081 | Not recruiting | No | 18 Years | N/A | All | May 1, 2020 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Informed consent must be obtained prior to participation in the study
<br>
<br> 2. Adult patient = 18 years old
<br>
<br> 3. Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by
<br> polymerase chain reaction (PCR) test from respiratory tract specimen (e.g
<br> nasopharyngeal swab)
<br>
<br> 4. Onset of signs and symptoms of COVID19 illness = 7 days prior to randomization
<br> (including but not limited to fever, cough, myalgias, fatigue, abnormal chest imaging)
<br>
<br> 5. Currently hospitalized or requiring hospitalization due to COVID-19 disease
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Use of other investigational drugs or newly approved COVID-19 treatments within 5-half
<br> lives or 30 days of enrolment
<br>
<br> 2. History of hypersensitivity to any of the study treatments or its excipients or to
<br> drugs of similar chemical classes
<br>
<br> 3. Participation in any other clinical trial of an experimental treatment for COVID-19
<br>
<br> 4. Expectation of concurrent treatment with any other agents or potential direct acting
<br> antiviral activity against SARS-Co V-2 during study drug dosing
<br>
<br> 5. Requires, in the judgement of the investigator, admission to the intensive care unit
<br> (ICU) or mechanical ventilatory support (invasive or non-invasive) prior to first dose
<br> of study drug (There might be a patient who cannot be admitted to the ICU, even if the
<br> patient's condition is severe enough, due to administrative reasons under the current
<br> circumstances. This case is also considered under admission to the ICU judged by the
<br> investigator)
<br>
<br> 6. Evidence of cytokine storm syndrome or multi-organ system failure
<br>
<br> 7. Confirmed co-infection with influenza
<br>
<br> 8. Creatinine clearance < 45 mL/min or requiring acute renal replacement therapy
<br>
<br> 9. History or current diagnosis of ECG abnormalities indicating significant risk of
<br> safety for participants participating in the study
<br>
<br> 10. Any other condition which in the opinion of the investigator, would put the safety of
<br> the participant at risk, impede compliance or hinder completion of the study
<br>
<br> 11. Pregnant or nursing (lactating) women
<br>
<br> 12. Women of child-bearing potential, defined as all women physiologically capable of
<br> becoming pregnant, unless they agree to use basic methods of contraception during
<br> dosing of study treatment.
<br> | | Covid-19 | Drug: HCQ;Drug: HCQ+AZT;Drug: Placebo | Number of Participants Who Achieved Clinical Response by Day 15 | 17/03/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04358081 | Yes | False | | Yes |
| --- | NCT04362137 | 18 October 2021 | Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm | Phase 3 Randomized, Double-blind, Placebo-controlled Multi-center Study to Assess the Efficacy and Safety of Ruxolitinib in Patients With COVID-19 Associated Cytokine Storm (RUXCOVID) | RUXCOVID | Novartis Pharmaceuticals | 22/04/2020 | 20200422 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04362137 | Not recruiting | Yes | 12 Years | N/A | All | May 2, 2020 | 432 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 3 | United States;Argentina;Brazil;Colombia;France;Germany;Mexico;Peru;Russian Federation;Spain;Turkey;United Kingdom;Argentina;Brazil;Colombia;France;Germany;Mexico;Peru;Russian Federation;Spain;Turkey;United Kingdom;United States;Canada;Italy | | Novartis Pharmaceuticals | | | | Novartis Pharmaceuticals |
<br> Inclusion Criteria:
<br>
<br> Patient or guardian/health proxy must provide informed consent (and assent if applicable)
<br> before any study assessment is performed.
<br>
<br> Male and female patients aged = 12 years (or = the lower age limit allowed by Health
<br> Authority and/or Ethics Committee/Institutional Review Board approvals).
<br>
<br> Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction
<br> (PCR) test or another rapid test from the respiratory tract prior to randomization.
<br>
<br> Patients currently hospitalized or will be hospitalized prior to randomization.
<br>
<br> Patients, who meet at least one of the below criteria:
<br>
<br> - Pulmonary infiltrates (chest X ray or chest CT scan);
<br>
<br> - Respiratory frequency = 30/min;
<br>
<br> - Requiring supplemental oxygen;
<br>
<br> - Oxygen saturation = 94% on room air;
<br>
<br> - Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg
<br> (1mmHg=0.133kPa) (corrective formulation should be used for higher altitude regions
<br> (over 1000m).
<br>
<br> Exclusion Criteria:
<br>
<br> History of hypersensitivity to any drugs or metabolites of similar chemical classes as
<br> ruxolitinib.
<br>
<br> Presence of severely impaired renal function defined by serum creatinine > 2 mg/dL (>176.8
<br> µmol/L), or have estimated creatinine clearance < 30 ml/min measured or calculated by
<br> Cockroft Gault equation or calculated by the updated bedside Schwartz equation.
<br>
<br> Suspected uncontrolled bacterial, fungal, viral, or other infection (besides COVID-19).
<br>
<br> Currently intubated or intubated between screening and randomization. In intensive care
<br> unit (ICU) at time of randomization. Intubated or in ICU for COVID-19 disease prior to
<br> screening. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs
<br> (i.e. tocilizumab, ruxolitinib, canakinumab, sarilumab, anakinra).
<br>
<br> Unable to ingest tablets at randomization. Pregnant or nursing (lactating) women
<br> | | Cytokine Storm (Covid-19) | Drug: Ruxolitinib;Drug: Placebo | Proportion of Patients Who Die, Develop Respiratory Failure [Require Mechanical Ventilation] or Require Intensive Care Unit (ICU) Care | 02/06/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04362137 | Yes | True | child | Yes |
| NCT04366765 | 18 October 2021 | COVID-19 Survival - The COVIVA Study | Coronavirus Disease 19 Survival - The COVIVA Study | COVIVA | University Hospital, Basel, Switzerland | 06/04/2020 | 20200406 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04366765 | Not recruiting | No | 18 Years | N/A | All | March 19, 2020 | 1325 | Observational | | | Switzerland | ; | Raphael Twerenbold, MD;Gabriela Kuster Pfister, MD | | ; | ; | Department of Cardiology and Cardiodiovascular Research Institute Basel (CRIB);Department of Cardiology, University Hospital Basel |
<br> Inclusion Criteria:
<br>
<br> - Clinically suspected or confirmed SARS-CoV-2 infection triaged to the ED
<br>
<br> - SARS-CoV-2 swab test performed (result may be pending at time of study enrolment)
<br>
<br> - Age =18 years
<br>
<br> - Patient or legally authorized representative is willing to sign local General consent
<br> form
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient or legally authorized representative is unable or unwilling to participate in
<br> the study.
<br> | | COVID-19;SARS-CoV 2 | | short-term prognosis | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04788459 | 18 October 2021 | Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers | A Phase I/II Study to Assess the Safety and Immunogenicity of COVID-eVax, a Candidate Plasmid DNA Vaccine for COVID-19, in Healthy Adult Volunteers | | Takis | 01/03/2021 | 20210301 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04788459 | Recruiting | No | 18 Years | 65 Years | All | February 25, 2021 | 160 | Interventional | Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1/Phase 2 | Italy | | Luigi Aurisicchio | | aurisicchio@takisbiotech.it | +39 06 50576077 | |
<br> Inclusion Criteria:
<br>
<br> 1. Signed and dated informed consent obtained before undergoing any study-specific
<br> procedure
<br>
<br> 2. Healthy male or female aged =18 and = 65 years
<br>
<br> 3. Body Mass Index >18.5 and =30 kg/m2
<br>
<br> 4. Vital signs within the following values or ranges:
<br>
<br> 1. Body temperature = 37,5 °C
<br>
<br> 2. Pulse frequency =51 and =100 beats per minute
<br>
<br> 3. Diastolic BP =60 mmHg, = 90 mmHg
<br>
<br> 4. Systolic BP = 90 mmHg, = 140 mmHg
<br>
<br> 5. Respiratory rate = 12 breaths per minute, = 16 breaths per minute
<br>
<br> 5. ECG at screening normal or with no clinically significant findings (pre-excitation
<br> syndromes, e.g., Wolff-Parkinson-White syndrome are absolute exclusion criteria)
<br>
<br> 6. Laboratory examinations within normal reference range or with no clinically
<br> significant abnormalities
<br>
<br> 7. Absence of any respiratory and flu-like symptoms
<br>
<br> 8. Non-pregnant women of childbearing potential, willing to practice a highly effective
<br> method of contraception from enrolment up to study completion or at least 90 days
<br> after the last vaccination in case of withdrawal
<br>
<br> 9. For sexually active men with a female partner of childbearing potential, willingness
<br> to use a condom and to refrain from donating sperm from enrolment up to study
<br> completion or at least 90 days after the last vaccination in case of withdrawal
<br>
<br> 10. Agreement to refrain from blood donation during the course of the study
<br>
<br> 11. Able and willing to comply with all study procedures.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. History of confirmed infection with SARS-CoV-2, by positive nasopharyngeal swab or by
<br> positive serological test for SARS-CoV-2 antibodies
<br>
<br> 2. Positive serological test for SARS-CoV-2 antibodies at screening
<br>
<br> 3. Subjects at high risk of SARS-CoV-2 infection prior or during the trial, including:
<br>
<br> 1. subjects with any known exposure in the 4 weeks before enrolment
<br>
<br> 2. close contacts of suspected or confirmed COVID-19 or SARS-CoV-2 infection cases
<br>
<br> 3. subjects quarantined for any reason
<br>
<br> 4. frontline healthcare professionals working in Emergency departments, ICU and
<br> other higher risk healthcare areas
<br>
<br> 4. Positive serological tests for:
<br>
<br> 1. Hepatitis B surface antigen (HBsAg)
<br>
<br> 2. Hepatitis C antibodies
<br>
<br> 3. Human Immunodeficiency Virus (HIV) antibodies
<br>
<br> 5. Subjects with any of the following specific contraindications, even in medical
<br> history:
<br>
<br> 1. Type 2 diabetes or glucose intolerance, even if controlled
<br>
<br> 2. Hypertension, even if controlled
<br>
<br> 3. chronic obstructive pulmonary disease (COPD)
<br>
<br> 4. Any cardiac disease, even if not evident at ECG
<br>
<br> 5. Pacemaker
<br>
<br> 6. Use of any investigational drugs/treatments, or enrolment in a clinical trial during
<br> the 6 months preceding screening
<br>
<br> 7. Prior administration of any vaccine in the 2 weeks preceding screening
<br>
<br> 8. Administration of any monoclonal or polyclonal antibody product within 4 weeks
<br> preceding screening
<br>
<br> 9. Administration of any blood product within 3 months of screening
<br>
<br> 10. Current or prior administration, within the 6 months preceding screening, of
<br> immunosuppressants (inhaled, topical skin and/or eye drop-containing corticosteroids;
<br> a short course of corticosteroids, defined as =20 mg/day prednisone or equivalent for
<br> 10 days, and low-dose methotrexate are allowed until 4 weeks prior to screening)
<br>
<br> 11. Any prior major surgery or any chemo- or radiation therapy within 5 years of screening
<br>
<br> 12. Current or suspected immunosuppressive or immunodeficient state, including HIV
<br> infection, asplenia, recurrent severe infections
<br>
<br> 13. Active, known, or suspected autoimmune disease (except mild psoriasis, well-controlled
<br> autoimmune thyroid disease, vitiligo or stable coeliac disease not requiring
<br> immunosuppressive or immunomodulatory therapy)
<br>
<br> 14. Bleeding disorders (e.g. coagulopathy or platelet disorder or coagulation factor
<br> deficiency) or prior history of significant bleeding or bruising following IM
<br> injections or venipuncture
<br>
<br> 15. History of seizures or mental illness
<br>
<br> 16. History of allergy to vaccines or of severe allergic reaction of any kind
<br>
<br> 17. Metal implants within 20 cm of the planned site(s) of injection
<br>
<br> 18. Presence of keloid scar formation or hypertrophic scar, or other clinically
<br> significant medical condition at the planned site(s) of injection
<br>
<br> 19. Any abnormality or permanent body art (e.g. tattoos) that would interfere with the
<br> ability to observe local reactions at the injection site in the deltoid area
<br>
<br> 20. History of alcohol or drug abuse during the 12 months preceding the screening
<br>
<br> 21. Pregnancy (i.e. positive pregnancy test) or willingness/intention to become pregnant
<br> during the study
<br>
<br> 22. Breastfeeding
<br>
<br> 23. Any other clinically relevant disease and condition that, in the opinion of the
<br> Investigator, may jeopardize efficacy or safety assessments or may compromise the
<br> subject's safety during trial participation.
<br> | | COVID-19;Protection Against COVID-19 and Infections With SARS-CoV- 2;COVID-19 Immunisation | Biological: COVID-eVax;Device: Cliniporator® and EPSGun | Percentage of subjects who seroconverted (for Phase 2);Change from baseline in antigen-specific cellular immune responses to SARS-CoV-2 (for Phase 2);SARS-CoV-2 neutralizing antibody titer (for Phase 2);Quantitative antibody titers, binding to the specific SARS-CoV-2 antigen (for Phase 2);Creatine Phosphokinase (CPK) levels (for Phase 1);Aspartate Transaminase (AST) levels (for Phase 1);Alanine Transaminase (ALT) levels (for Phase 1);Platelets levels (for Phase 1);Red Blood Cell (RBC) levels (for Phase 1);White Blood Cell (WBC) levels (for Phase 1);Incidence of unsolicited AEs (for Phase 1);Incidence of solicited systemic AEs (for Phase 1);Incidence of solicited local Adverse events (AEs) at the injection site (for Phase 1) | | | | Yes | False | | |
| → | NCT04793464 | 18 October 2021 | COVID-19: Healthy Oregon (Oregon Saludable): Together We Can (Juntos Podemos) | Scaling Up SARS-CoV-2 Testing to Serve Latinx Communities | OSJP | University of Oregon | 25/02/2021 | 20210225 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04793464 | Recruiting | No | 3 Years | N/A | All | February 4, 2021 | 3600 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). | N/A | United States | ; | Leslie D Leve, PhD;Kelsey Van Brocklin, BS | | ;kelseyvb@uoregon.edu | ;541-346-9530 | University of Oregon; |
<br> Inclusion Criteria:
<br>
<br> - Proportion Tested: Age 3 or older
<br>
<br> - Proportion Tested: Received testing at study testing site
<br>
<br> - Individual Survey: 18 or older
<br>
<br> Exclusion Criteria:
<br>
<br> • Individual Survey: Unable to understand Spanish or English or another language translated
<br> by a qualified translator at a 5th grade level
<br> | | Health Behavior;Health Care Utilization | Behavioral: Promotores de Salud;Behavioral: Services as usual | Latinx testing engagement;COVID-19 Prevention Health Behaviors;COVID-19 Knowledge and Attitudes;Attitudes Towards COVID-19 Vaccines→Attitudes Towards COVID-19 Vaccines;COVID-19 Knowledge and Attitudes;COVID-19 Prevention Health Behaviors;Latinx testing engagement | | | | Yes | False | | |
| NCT04794998 | 18 October 2021 | A Simple Approach to Treat COVID-19 Patients at Home. | A Simple Approach to Treat COVID-19 Patients at Home: Does it Reduce Recovery Time? A Retrospective Observational Matched-cohort Study | COVER | Mario Negri Institute for Pharmacological Research | 10/03/2021 | 20210310 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04794998 | Not recruiting | No | 18 Years | N/A | All | February 8, 2021 | 180 | Observational | | | Italy | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Male and female adult (=18 years old)
<br>
<br> - Subjects with early mild symptoms of COVID-19, without waiting results of a
<br> nasopharyngeal swab, if any
<br>
<br> - Informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects who require immediate hospital admission because severe COVID-19 symptoms at
<br> onset according to family doctor opinion
<br> | | COVID 19 | Drug: Recommended treatment schedule;Drug: Control treatment schedule | Time to complete remission | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04931888 | 18 October 2021 | Implementing and Evaluating a Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic | Implementing and Evaluating a Wellness and Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic: EMPOWER (Emotions Program Outside the Clinic and Wellness Education for Refugees) | | Yale University | 11/06/2021 | 20210611 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04931888 | Recruiting | No | 5 Years | 15 Years | All | June 23, 2021 | 70 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | United States | | Julia Rosenberg, MD MHS | | | | Yale University |
<br> Inclusion Criteria:
<br>
<br> - at least 1 year of schooling in the United States
<br>
<br> - must speak: Pashto, Dari or English
<br>
<br> - connected with the community organization: Elena's Light
<br>
<br> Exclusion Criteria:
<br>
<br> - inability to meet any of the requirements of the inclusion criteria
<br> | | Social Emotional Wellness | Behavioral: EMPOWER | Change in COVID-19 Knowledge;Change in Social Emotional Competence | | | | Yes | False | | |
| → | NCT04944368 | 18 October 2021 | Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen) | A Phase II, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen) | | Cinnagen | 19/06/2021 | 20210619 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04944368 | Not recruiting | No | 18 Years | N/A | All | May 30, 2021 | 400 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | Iran, Islamic Republic of | | Payam Tabarsi, M.D. | | | | Shahid Beheshti University of Medical Sciences |
<br> Inclusion Criteria:
<br>
<br> - Male or female =18 years
<br>
<br> - Willing and able to comply with all study requirements, including scheduled visits,
<br> interventions, and laboratory tests
<br>
<br> - Healthy adults or adults in a stable medical condition, defined as not being
<br> hospitalized within 3 months prior to the screening visit
<br>
<br> - Females must not be pregnant or breastfeeding
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects with signs of active SARS-COV-2 infection at the screening visit.
<br>
<br> - Subjects with body temperature of 38 degrees Celsius or greater at the screening visit
<br> or within 72 hours prior to the screening visit.
<br>
<br> - Subjects with a history of any progressive or severe neurological disorders, seizure,
<br> or Guillain-Barre syndrome.
<br>
<br> - Subjects who receive immunosuppressive or cytotoxic medications.
<br>
<br> - Female Subjects who are pregnant or breastfeeding or have planned to become pregnant
<br> during the study period.
<br>
<br> - Subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the
<br> study vaccine, any components of the study interventions, or any pharmaceutical
<br> products.
<br>
<br> - Subjects who have received any other investigational products within 30 days prior to
<br> the screening visit or intend to participate in any other clinical studies during the
<br> period of this study.
<br>
<br> - Subjects who have been vaccinated with any vaccine or vaccine candidate against
<br> SARS-CoV-2.
<br>
<br> - Subjects who have received any vaccines within 28 days prior to the screening visit or
<br> intend to receive any vaccines up to 14 days after the second dose of the study
<br> injection.
<br>
<br> - Subjects who have any known bleeding disorders or, in the investigator's opinion, have
<br> any contraindications for an intramuscular injection.
<br>
<br> - Subjects who have received any blood, plasma, or immunoglobulin products from 90 days
<br> prior to the screening visit or intend to receive during the study period.
<br>
<br> - Subjects with any condition that may increase the risk of participating in the study
<br> or may interfere with the evaluation of the primary endpoints of the study in the
<br> investigator's opinion.
<br>
<br> - Subjects who have donated =450 mL of blood or blood products within 28 days prior to
<br> the screening visit.
<br> | | Covid19 | Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant;Biological: Saline placebo | Change in geometric mean concentration (GMC) for S-protein binding IgG antibodies from baseline to 14 days after the second injection;Change in geometric mean concentration (GMC) for S-protein binding IgG antibodies from baseline to 21 days after the first injection;Percentage of participants with seroconversion for S-protein binding IgG antibodies after the second injection;Percentage of participants with seroconversion for S-protein binding IgG antibodies after the first injection;Incidence of unsolicited adverse events;Incidence of solicited adverse events→Incidence of unsolicited adverse events;Percentage of participants with seroconversion for S-protein binding IgG antibodies after the first injection;Percentage of participants with seroconversion for S-protein binding IgG antibodies after the second injection;Change in geometric mean concentration (GMC) for S-protein binding IgG antibodies from baseline to 21 days after the first injection;Change in geometric mean concentration (GMC) for S-protein binding IgG antibodies from baseline to 14 days after the second injection;Incidence of solicited adverse events | | | | Yes | False | | |
| NCT04961229 | 18 October 2021 | Booster Dose of COVID-19 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response | Booster Dose of mRNA SARS-CoV-2 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response With or Without Immunosuppression Reduction - Protocol for a Randomised Controlled Trial (BECAME Study) | WHO | dafna yahav | 13/07/2021 | 20210713 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04961229 | Not recruiting | No | 18 Years | N/A | All | October 2021 | 504 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 4 | | ; | Ruth Rahaminov;Ruth Rahaminov | | ;rutir@clalit.org.il | ;97239376475 | Rabin Medical Center, Beilinson Campus, Petah-Tikva, Israel; |
<br> Inclusion Criteria:
<br>
<br> - kidney transplant recipients that received two doses of BNT162b2 vaccine at least 3
<br> weeks prior to enrollment, and were seronegative (IgG against the spike protein of
<br> SARS-CoV-2 below 50 AU/ml) at least two weeks after the second vaccine dose
<br>
<br> Additional inclusion criteria for the RCT:
<br>
<br> - Recipients treated by three anti-rejection medications including: prednisone,
<br> tacrolimus, mycophenolate mofetil or mycophenolic acid.
<br>
<br> - Tacrolimus trough blood levels 5-10 nGr/ml (lower or higher doses will have to be
<br> adjusted before re-considering for inclusion)
<br>
<br> Exclusion Criteria:
<br>
<br> - Past infection with SARS-CoV-2
<br>
<br> - Pregnancy
<br>
<br> - Age below 18 years
<br>
<br> - Active infection
<br>
<br> Additional exclusion criteria for RCT only:
<br>
<br> - Recipients at a high risk for acute or chronic humoral rejection including:
<br>
<br> - Recipients with positive panel-reactive antibody (PRA) (any positive value) at any
<br> time before or after transplantation
<br>
<br> - Recipients that had an acute rejection in the last year
<br>
<br> - Recipients less than 6 months after transplantation
<br>
<br> - Recipients that are considered at high risk for rejection according to the primary
<br> care nephrologist
<br>
<br> - Recipients taking less than 3 anti-rejection medications
<br>
<br> - Recipients currently treated with mTOR inhibitors (everolimus, sirolimus) and/or
<br> azathioprine
<br>
<br> - Recipients treated with plasmapheresis in the previous 3 months
<br>
<br> - Recipients treated with eculizumab in the last year
<br>
<br> - Recipient treated with IVIG in the previous 3 months
<br>
<br> - Recipient treated with rituximab in the previous 6 months
<br> | | COVID-19 Acute Respiratory Distress Syndrome;Immunosuppression | Biological: The Pfizer mRNA-based BNT162b2 vaccine | anti-spike protein titer above 50 AU/ml 2 weeks post vaccination | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05003271 | 18 October 2021 | Pulmonary Rehabilitation Post-COVID-19 | Pulmonary Rehabilitation Post-COVID-19: a Pilot Study | | University of Manitoba | 06/08/2021 | 20210806 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05003271 | Not recruiting | No | 18 Years | N/A | All | October 2021 | 24 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | | ; | Diana C Sanchez-Ramirez, PhD;Diana C Sanchez-Ramirez, PhD | | ;diana.sanchez-ramirez@umanitoba.ca | ;12044801346 | University of Manitoba; |
<br> Inclusion Criteria:
<br>
<br> - Post-COVID-19 = 3 months after infection.
<br>
<br> - Mild to severe persistent respiratory symptoms
<br>
<br> - Access to a smart phone, tablet or computer and home internet
<br>
<br> Exclusion Criteria:
<br>
<br> - History of neurological disease or mental illness
<br>
<br> - Inability to ambulate independently without supervision
<br>
<br> - Inability to complete basic tasks on a smart phone or tablet
<br> | | COVID-19 | Other: Exercise program (virtual/remote) | Change in lung capacity;Change in dyspnea;Change in fatigue;Change in exercise capacity;Change in post-exercise saturation;Changes in health-related quality of life (HRQoL) assessed with the Short form (SF)-36 questionnaire;Changes in health-related quality of life (HRQoL) assessed with the EQ-5D-5L;Change in activities participation;Change in physical function | | | | Yes | False | | |
| → | NCT05005559 | 18 October 2021 | Phase III Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen) | A Phase III, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen) | | Cinnagen | 11/08/2021 | 20210811 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05005559 | Not recruiting | No | 18 Years | 50 Years | All | August 7, 2021 | 16876 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | Iran, Islamic Republic of | | Payam Tabarsi, M.D. | | | | Shahid Beheshti University of Medical Sciences |
<br> Inclusion Criteria:
<br>
<br> - Male or female between 18 years of age and less than 50 years
<br>
<br> - Willing and able to comply with all study requirements, including scheduled visits,
<br> interventions, and laboratory tests
<br>
<br> - Healthy adults or adults in a stable medical condition, defined as not being
<br> hospitalized within 3 months prior to the screening visit
<br>
<br> - Females must not be pregnant or breastfeeding
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects with signs of active SARS-COV-2 infection at the screening visit.
<br>
<br> - Subjects with body temperature of 38 degrees Celsius or greater at the screening visit
<br> or within 72 hours prior to the screening visit.
<br>
<br> - Subjects with a history of any progressive or severe neurological disorders, including
<br> dementia, stroke, seizure, and Guillain-Barre syndrome.
<br>
<br> - Female Subjects who are pregnant or breastfeeding or have planned to become pregnant
<br> during the study period.
<br>
<br> - Subjects who have a history of severe allergic reactions (e.g., anaphylaxis) to the
<br> study vaccine, any components of the study interventions, or any pharmaceutical
<br> products.
<br>
<br> - Subjects who have received any other investigational products within 30 days prior to
<br> the screening visit or intend to participate in any other clinical studies during the
<br> period of this study.
<br>
<br> - Subjects who have been vaccinated with any vaccine or vaccine candidate against
<br> SARS-CoV-2.
<br>
<br> - Subjects who have received any vaccines within 28 days prior to the screening visit or
<br> intend to receive any vaccines up to 14 days after the second dose of the study
<br> injection.
<br>
<br> - Subjects who have any known bleeding disorders or, in the investigator's opinion, have
<br> any contraindications for an intramuscular injection.
<br>
<br> - Subjects who have received any blood, plasma, or immunoglobulin products from 90 days
<br> prior to the screening visit or intend to receive during the study period.
<br>
<br> - Subjects with any condition that may increase the risk of participating in the study
<br> or may interfere with the evaluation of the primary endpoints of the study in the
<br> investigator's opinion.
<br>
<br> - Subjects who have donated =450 mL of blood or blood products within 28 days prior to
<br> the screening visit.
<br>
<br> - Subjects with end-stage renal disease
<br>
<br> - Subjects with Down syndrome
<br>
<br> - Subjects with a body mass index of 40 kg/m2 or more
<br>
<br> - Subjects with cystic fibrosis, chronic obstructive pulmonary disease, or pulmonary
<br> arterial hypertension
<br>
<br> - Subjects with uncontrolled asthma, hypertension, or diabetes mellitus
<br>
<br> - Subjects who receive cytotoxic medications or immunosuppressive drugs, including
<br> systemic corticosteroids at doses equivalent to prednisolone 10 mg or higher per day
<br> for more than 14 days.
<br>
<br> - Subjects who can get a COVID-19 vaccine within 2 months after the study enrollment
<br> date based on the national COVID-19 immunization program in Iran
<br> | | Covid19 | Biological: SARS-CoV-2 recombinant spike protein + Advax-SM adjuvant;Biological: Saline placebo | Occurrence of symptomatic COVID-19;Occurrence of severe COVID-19→Occurrence of severe COVID-19;Occurrence of symptomatic COVID-19 | | | | Yes | False | | |
| NCT05007236 | 18 October 2021 | Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild COVID-19 Infection. | A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Oral RP7214, a DHODH Inhibitor, in Patients With Symptomatic Mild SARS-CoV-2 Infection. | | Rhizen Pharmaceuticals SA | 09/08/2021 | 20210809 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05007236 | Recruiting | No | 18 Years | N/A | All | September 20, 2021 | 204 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | India | | Prajak Barde, MD | | pjb@rhizen.com | +41325800175 | |
<br> Inclusion Criteria:
<br>
<br> 1. Willing and able to provide informed consent.
<br>
<br> 2. Males and females of = 18 years of age
<br>
<br> 3. Patient with mild COVID-19 infection having = 1 symptoms.
<br>
<br> 4. Laboratory confirmed Covid-19 infection by Reverse Transcription Polymerase Chain
<br> Reaction (RT-PCR) in nasopharyngeal sample (within 72 hours prior to randomization).
<br>
<br> 5. Patient should have at least one pre-existing high-risk feature for developing severe
<br> Covid-19 illness.
<br>
<br> 6. Ability to swallow and retain oral medication.
<br>
<br> 7. Male patient who is surgically sterile, or who is willing to agree to use a
<br> contraceptive measure.
<br>
<br> 8. Women of childbearing potential should be willing to use a medically acceptable method
<br> of contraception.
<br>
<br> 9. Willing to receive telephone calls or have videoconferences with study team personnel.
<br>
<br> 10. Willing and able to understand the nature of this study, comply with the study
<br> procedures and follow-up procedures as per the study protocol.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patient with asymptomatic Covid-19 infection.
<br>
<br> 2. Patient who has experienced the onset of any of Covid-19 symptoms > 5 days at the time
<br> of randomization.
<br>
<br> 3. Moderate to Severe COVID-19 infection
<br>
<br> 4. Patient with Covid-19 re-infection
<br>
<br> 5. Subjects who are severely immunocompromised
<br>
<br> 6. Subjects with autoimmune diseases
<br>
<br> 7. Patients with any bleeding disorder e.g., hemophilia and von Willebrand disease.
<br>
<br> 8. Current use of other DHODH inhibitors including teriflunomide or leflunomide.
<br>
<br> 9. Patients who are on or immediately require Covid-19 directed treatment such as
<br> antivirals, immunomodulatory treatment, convalescent plasma, oral/ intravenous
<br> steroids, or monoclonal antibodies at the time of screening.
<br>
<br> 10. Patients who have had received one or two doses of vaccine for Covid-19.
<br>
<br> 11. Patients participating in another clinical study or use of any investigational product
<br> within 4 weeks or 5 half-lives of the drug, whichever is longer, before the date of
<br> dosing
<br> | | SARS-CoV-2 Infection | Drug: RP7214 + Standard of care (SOC);Drug: Placebo + Standard of care (SOC) | Proportion of patients requiring Covid-19 related hospitalization by Day 15. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05011812 | 18 October 2021 | Study of PBI-0451 in Healthy Subjects. | A Single and Multiple Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of PBI-0451 in Healthy Subjects. | | Pardes Biosciences, Inc. | 11/08/2021 | 20210811 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05011812 | Recruiting | No | 18 Years | 59 Years | All | August 14, 2021 | 120 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 1 | New Zealand | ; | Mark Marshall;Andrew Plummer | | ;Andrew@pardesbio.com | ;+14156719107 | New Zealand Clinical Research; |
<br> Inclusion Criteria:
<br>
<br> 1. Non-smoking, healthy male or female subjects aged 18-59 years.
<br>
<br> 2. Body Mass Index (BMI) of = 19.0 and = 30.0 kg/m2.
<br>
<br> 3. 12-Lead electrocardiogram (ECG) evaluation without clinically significant
<br> abnormalities.
<br>
<br> 4. Normal renal function, including having a creatinine clearance (CLcr) =90mL/min
<br>
<br> 5. Male subjects and female subjects of childbearing potential who engage in heterosexual
<br> intercourse must agree to use protocol-specified method(s) of contraception.
<br>
<br> 6. Screening laboratory assessments must be without clinically significant abnormalities
<br> as assessed by the investigator.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnant and lactating females
<br>
<br> 2. Have received any investigational drug (or vaccine) within the last 30 days prior to
<br> study dosing.
<br>
<br> 3. Have a positive test result for HIV or HBsAg.
<br>
<br> 4. Have poor venous access that limits phlebotomy
<br>
<br> 5. Have taken any prescription medications or over-the-counter medications, including
<br> herbal products and dietary supplements within 28 days prior to start of study.
<br>
<br> 6. Have been treated with systemic steroids, immunosuppressant therapies, or
<br> chemotherapeutic agents within 3 months prior to Screening or is expected to receive
<br> these agents during the study.
<br>
<br> 7. Have a history of lymphoma, leukemia, or any malignancy within the past 5 years except
<br> for basal cell or squamous epithelial carcinomas of the skin that have been resected
<br> with no evidence of metastatic disease for 3 years.
<br>
<br> 8. Have a history of significant drug sensitivity, cardiac disease, syncope,
<br> palpitations, or unexplained dizziness, implanted defibrillator or pacemaker, liver
<br> disease, severe peptic ulcer disease, gastroesophageal reflux disease and a medical or
<br> surgical treatment that permanently altered gastric absorption.
<br>
<br> 9. Have received inactivated vaccinations within 4 weeks prior to randomization or
<br> receive live vaccinations within 4 weeks of Screening.
<br>
<br> 10. Received the COVID-19 vaccine either within 7 days or have not completed the series of
<br> required 2 doses.
<br>
<br> 11. Have a history of excessive alcohol use or other illicit drug use within 6 months of
<br> screening.
<br> | | Covid19 | Drug: PBI-0451 Dose 1;Drug: PBI-0451 Dose 2;Drug: PBI-0451 Dose 3;Drug: PBI-0451 Dose 4;Drug: Ritonavir;Drug: Midazolam;Drug: Placebo;Drug: PBI-0451 | Number of subjects with treatment emergent adverse events (TEAEs) in Single Ascending Dose (SAD) compared to placebo;Number of subjects with clinically significant change from Baseline in vital signs in SAD;Number of patients with laboratory abnormalities in SAD;Number of subjects with treatment emergent adverse events (TEAEs) in Multiple Ascending Dose (MAD) compared to placebo;Number of subjects with clinically significant change from Baseline in vital signs in MAD;Number of patients with laboratory abnormalities in MAD | | | | Yes | False | | |
| → | NCT05022303 | 18 October 2021 | AT1001 for the Treatment of COVID-19 Related MIS-C | A Phase 2a (Proof of Concept), Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AT1001 for the Treatment of COVID-19 Related Multisystem Inflammatory Syndrome in Children (MIS-C) | | Massachusetts General Hospital | 09/08/2021 | 20210809 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05022303 | Recruiting | No | 1 Month | 21 Years | All | October 2021 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | United States | ; | Lael Yonker, MD;Lael Yonker, MD | | lyonker@mgh.harvard.edu;LYONKER@MGH.HARVARD.EDU | 617-726-8707;617-726-8707 | |
<br> Inclusion Criteria:
<br>
<br> 1. Pediatric patients with or without comorbidity
<br>
<br> 2. Age = 1 month to < 21 years
<br>
<br> 3. Confirmed MIS-C by signs and symptoms as detailed by the CDC Health Advisory
<br> (https://www.cdc.gov/mis-c/hcp/; May 14, 2020)
<br>
<br> 1. Persistent fever/chills (>38.0°C for =24 hours, or report of subjective fever
<br> lasting =24 hours); AND
<br>
<br> 2. One or more laboratory parameters (evidence of inflammation); AND,
<br>
<br> i) elevated C-reactive protein (CRP) ii) elevated erythrocyte sedimentation rate (ESR)
<br> iii) elevated ferritin iv) elevated lactic acid dehydrogenase (LDH) v) elevated
<br> d-dimer vi) elevated fibrinogen vii) elevated procalcitonin viii) elevated interleukin
<br> 6 (IL-6) ix) increased neutrophils x) reduced lymphocytes xi) low albumin c) Evidence
<br> of clinically severe illness requiring hospitalization, with multisystem (>2) organ
<br> involvement (cardiac, renal, respiratory, hematologic, gastrointestinal, dermatologic,
<br> or neurological)-MUST include GI symptoms, such as nausea, vomiting, diarrhea and/or
<br> abdominal pain; AND, d) No alternative plausible diagnoses; AND e) Positive for
<br> current or recent SARS-CoV-2 infection by RT-PCR, serology, or antigen test
<br>
<br> 4. Subject (or legal authorized representative) capable of understanding and signing an
<br> informed consent form and assent form, when appropriate.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Female participants pregnant and/or lactating.
<br>
<br> 2. Female participant has childbearing potential and is unwilling to use an acceptable
<br> method of birth control for the duration of the study.
<br>
<br> 3. Participant has a significant co-morbid disease that by the Investigator's
<br> determination would make the participant unsuitable for enrollment, including unstable
<br> medical conditions.
<br>
<br> 4. Participation in any other clinical investigation using an experimental drug within 30
<br> days prior to screening or intends to participate in another clinical study while
<br> participating in AT1001 MIS-C 101 study.
<br>
<br> 5. Have participated in a blood/plasma donation or blood loss greater than 400 mL within
<br> 90 days, or greater than 200 mL within 30 days prior to Screening.
<br>
<br> 6. Known hypersensitivity to any of the formulation components of AT1001.
<br> | | Covid19;Multisystem Inflammatory Syndrome in Children | Drug: Larazotide Acetate;Drug: Placebo | Evaluate the efficacy and safety of AT1001 versus placebo on mitigating symptoms of MIS-C;Determine proportion of participants with improvement in MIS-C related GI symptoms and no progression of disease→Determine proportion of participants with improvement in MIS-C related GI symptoms and no progression of disease;Evaluate the efficacy and safety of AT1001 versus placebo on mitigating symptoms of MIS-C | | | | Yes | False | | |
| NCT05022329 | 18 October 2021 | COVID-19 Vaccine Boosters in Patients With CKD | A Multi-Centre 12 Month Parallel-Group Randomized Control Trial of BNT162b2 Versus mRNA( Messenger Ribonucleic Acid) -1273 COVID-19 Vaccine Boosters in Chronic Kidney Disease and Dialysis Patients With Poor Humoral Response Following COVID-19 ( Corona Virus Disease of 2019)Vaccination | BOOST KIDNEY | Sunnybrook Health Sciences Centre | 23/08/2021 | 20210823 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05022329 | Recruiting | No | 18 Years | N/A | All | September 30, 2021 | 300 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2/Phase 3 | Canada | | Dr. Michelle Hladunewich, MD, FRCPC | | Michelle.Hladunewich@sunnybrook.ca | 416 480 4592 | |
<br> Inclusion Criteria:
<br>
<br> - Patients with Chronic Kidney Disease (CKD)stage 3b-5 defined as an eGFR( estimated
<br> glomerular filtration rate ) of less than 45ml/min/1.73m2 or less will be eligible.
<br> Stage 5 CKD will include patients receiving in-center hemodialysis, home dialysis
<br> (home hemodialysis or peritoneal dialysis), vaccinated with two doses of the COVID-19
<br> vaccine will be eligible for a third dose to be given 2-12 months following the second
<br> dose.
<br>
<br> - Participants with a serum Anti-RBD (Anti-Receptor Binding Domain) relative ratio on
<br> their most recent measurement below the median convalescent serum relative ratio in
<br> patients with prior COVID-19.
<br>
<br> - Age =18 at the time of study enrolment
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients not vaccinated against COVID-19 vaccination.
<br>
<br> - Patients who received heterologous first two doses of vaccine
<br>
<br> - Patients with a severe allergic reaction to prior COVID-19 vaccination or any of the
<br> ingredients.
<br>
<br> - New COVID-19 infection
<br> | | Chronic Kidney Diseases;COVID-19 | Biological: Pfizer-BioNTech COVID-19 Vaccine;Biological: MODERNA SARS-CoV-2 Vaccine | Serum Level of Anti-RBD ( Anti Receptor Binding Domain ) | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05037110 | 18 October 2021 | Physical Activity and Smell Trainings to Help Individuals With Coronavirus Disease (COVID-19) Recover From Persistent Smell and Taste Impairments - A Pilot Study | Physical Activity and Sensory Trainings to Help COVID-19 Patients Recover From Persistent Smell and Taste Impairments - A Pilot Study | CAPS | Université de Montréal | 02/09/2021 | 20210902 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05037110 | Recruiting | No | 18 Years | N/A | All | October 2021 | 75 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Canada | ; | Marie-Eve Mathieu, PhD;Marie-Eve Mathieu | | me.mathieu@umontreal.ca;me.mathieu@umontreal.ca | 514 343-6737;5143436737 | |
<br> Inclusion Criteria:
<br>
<br> - Be 18 years old and above
<br>
<br> - Have had COVID-19 diagnosed by laboratory tests
<br>
<br> - Have recovered from COVID-19
<br>
<br> - Have persistent problems with your sense of smell and/or taste due to COVID-19 in the
<br> past 3 months or more (priority to participants with only this complication)
<br>
<br> - Have access to a computer and internet connection and be able to download the Zoom
<br> application
<br>
<br> - Have access to a smart phone ("texting" and Bluetooth)
<br>
<br> - Live in Canada
<br>
<br> Exclusion Criteria:
<br>
<br> - Do 150 minutes or more of physical activity that makes you out of breath every week
<br>
<br> - Have limitations related to a training aiming at improving the sense of smell
<br>
<br> - Have physical limitations that may limit physical activity
<br>
<br> - Be part of another study that may influence the current study
<br> | | Covid19 | Behavioral: Physical activity;Other: Smell training | Changes from baseline in olfactory score on the 40-item University of Pennsylvania Smell Identification Test (UPSIT) at week 14;Changes from Week 14 in olfactory score on the 40-item University of Pennsylvania Smell Identification Test (UPSIT) at Week 26.;Changes from Baseline in Gustatory Score on the 27-item Waterless Empirical Taste Test (WETT-SA) at Week 14;Changes from Week 14 in food intake on the four 24-hour dietary recall at Week 26;Changes from Baseline in food intake on the four 24-hour dietary recall at Week 14;Changes from Week 14 in Brain Responses Following Taste Stimulations at Week 26;Changes from Week 14 in Brain Responses Following Smell Stimulations at Week 26;Changes from Baseline in Brain Responses Following Taste Stimulations at Week 14;Changes from Baseline in Brain Responses Following Smell Stimulations at Week 14;Changes from Week 14 in Food Preference on the Leeds Food Preference Questionnaire (LFPQ) at Week 26;Changes from Baseline in Food Preference on the Leeds Food Preference Questionnaire (LFPQ) at Week 14;Changes from Week 14 in Quality of Life on the 26-item World Health Organizations Quality of Life - Bref (WHOQoL-Bref) Questionnaire at Week 26;Changes from Baseline in Quality of Life on the 26-item World Health Organizations Quality of Life - Bref (WHOQoL-Bref) Questionnaire at Week 14;Changes from Week 14 in Gustatory Score on the 27-item Waterless Empirical Taste Test (WETT-SA) at Week 26 | | | | Yes | False | | |
| → | NCT05047445 | 18 October 2021 | A First Time in Human Phase 1 Open-Label Study of the COVIDITY Vaccine Administered by Needle-free Injection | A First Time in Human Phase 1 Open-Label Study of the Safety, Tolerability, and Immunogenicity of COVIDITY Vaccine Administered by Needle-free Intradermal Injection or Needle-free Intramuscular Injection in Healthy Adults (COVIDITY-001) | | Scancell Ltd | 27/08/2021 | 20210827 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05047445 | Recruiting | No | 18 Years | 59 Years | All | September 30, 2021 | 40 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1 | South Africa | ; ; | Rodney Dawson, MD;Robert Miller;Rodney Dawson, MD | | ;info@scancell.co.uk; | ;+44 (0)1865 582 690; | University of Cape Town Lung Institute; |
<br> Inclusion Criteria:
<br>
<br> - Participant is able and willing to provide written informed consent prior to any study
<br> procedure.
<br>
<br> - Participant is 18 to 59 years of age.
<br>
<br> - Participant is male or non-pregnant female.
<br>
<br> - Participant has had no known exposure to SARS-CoV-2 virus in the last 14 days and has
<br> a negative RT-PCR SARS-CoV-2 laboratory test 24-48 hours prior to initial vaccination.
<br>
<br> - SARS-CoV-2 antibodies:
<br>
<br> - Negative for SARS-CoV-2 antibodies, or
<br>
<br> - Positive for SARS-CoV-2 antibodies with no known clinical history of COVID-19
<br> infection (asymptomatic) (Note: up to a maximum of 5 such participants per
<br> treatment arm).
<br>
<br> - Participant is determined by the Investigator to be healthy on the basis of medical
<br> history, physical examination, vital signs, and routine laboratory tests.
<br>
<br> - Participant agrees to comply with study procedures, including the collection of venous
<br> blood, and to be available for all study visits.
<br>
<br> - Women of child-bearing potential must have a negative urine pregnancy test during
<br> screening and a negative serum pregnancy test on Day -1 (prior to the first dose) and
<br> be neither breastfeeding nor intending to become pregnant during study participation.
<br> Women of child-bearing potential must agree to use highly effective contraceptive
<br> methods at least 28 days prior to study entry, for the duration of study
<br> participation, and for 120 days after the last dose of study vaccine.
<br>
<br> - Men who are potentially fertile must agree to use barrier protection for the duration
<br> of their participation in the study and until 120 days after administration of the
<br> last dose of study vaccine when they engage in sexual relations with women who are of
<br> child-bearing potential, pregnant, or lactating; they also agree to request their
<br> female partners to use an effective method of contraception if they are of
<br> child-bearing potential.
<br>
<br> - Participant has an oral temperature of less than 37.5°C at screening and prior to
<br> dosing.
<br>
<br> - Participant has a screening ECG with none of the following clinically significant
<br> findings:
<br>
<br> - PR-interval >210 msec
<br>
<br> - QRS-duration >120 msec
<br>
<br> - QT-interval >500 msec
<br>
<br> - QTcF-interval >450 msec (males), >470 msec (females)
<br>
<br> - Pathologic Q wave
<br>
<br> - Significant ST-T wave changes
<br>
<br> - Second or third-degree atrioventricular heart block.
<br>
<br> - Participant agrees to refrain from donating blood or plasma, outside of the study, for
<br> the duration of study participation, and for 28 days after the last dose of study
<br> vaccine.
<br>
<br> - Participant agrees not to consume any alcohol within 48 hours prior to each study
<br> vaccine administration.
<br>
<br> Exclusion Criteria:
<br>
<br> - Participant has a history of chronic respiratory disease, hypertension, significant
<br> cardiovascular disease, autoimmune disease (including hypothyroidism without defined
<br> non-autoimmune cause), immunodeficiency, clotting disorder, history of thrombosis, or
<br> malignancy (except for adequately treated malignancies with an expected 5-year
<br> survival rate of >90%, e.g., carcinoma in-situ of the breast or cervix, squamous or
<br> basal cell carcinoma of the skin).
<br>
<br> - Participant has any medical disease or condition, or psychiatric condition, which in
<br> the opinion of the Investigator would preclude study participation (would place the
<br> participant at an unacceptable risk of injury, render the participant unable to meet
<br> the requirements of the protocol, or may interfere with the evaluation of responses).
<br>
<br> - Participant has a positive test result for hepatitis B surface antigen, hepatitis C
<br> virus antibody, or human immunodeficiency virus types 1 or 2 antibodies at screening.
<br>
<br> - Alcohol consumption of >21 units per week (males) or >14 units per week (females) (1
<br> unit of alcohol equals 1/2 pint [285 mL] of beer or lager, 1 glass [125 mL] of wine,
<br> or 1/6 gill [25 mL] of spirits).
<br>
<br> - Strenuous exercise (e.g., heavy lifting, weight, or fitness training) within 96 hours
<br> (4 days) of screening and the first dosing visit.
<br>
<br> - Participant has participated in another investigational study involving an
<br> investigational product within 30 days, or 5 half-lives, whichever is longer, before
<br> the first study vaccine administration in the current study.
<br>
<br> - Participant is currently enrolled in, or plans to participate in, another clinical
<br> trial with an investigational product that will be received during the study-reporting
<br> period.
<br>
<br> - Participant has a history of any vaccine or drug hypersensitivity reactions (including
<br> skin reactions or anaphylaxis), or other known clinically significant allergies.
<br>
<br> - Participant has a history of chronic use (>14 continuous days in the 6 months
<br> preceding screening) of any medications that may be associated with impaired immune
<br> responsiveness including, but not limited to: systemic corticosteroids exceeding 10
<br> mg/day of prednisone equivalent, allergy injections, immunoglobulin, interferon,
<br> immunomodulators, cytotoxic drugs, or other immuno-suppressive drugs. The use of low
<br> dose topical, ophthalmic, inhaled, and intranasal steroid preparations is permitted
<br> (not more than the equivalent of 10 mg prednisone a day).
<br>
<br> - Use of any prescription medications within 14 days or 5 half-lives (whichever is
<br> longer) of first study vaccine administration (Day 1), use of over-the-counter
<br> medications, or herbal supplements within 7 days. The use of occasional paracetamol
<br> (up to 4 g per day) and hormone replacement therapy, oral, implantable, transdermal
<br> injectable, or intrauterine contraceptives is permitted. Nutritional supplements may
<br> be permitted but must be discussed with the Sponsor's medical monitor prior to
<br> participant enrolment.
<br>
<br> - Participant has received immunoglobulins and/or any blood or blood products within 90
<br> days before the first study vaccine administration (Day 1) or at any time during the
<br> study.
<br>
<br> - Participant has received a vaccine within 28 days of the first dose of study vaccine
<br> administration.
<br>
<br> - Participant has a history of alcohol abuse or other recreational drug (excluding
<br> cannabis) use within 6 months before the first study vaccine administration.
<br>
<br> - Participant has a positive result for the urine drugs of abuse test at screening or
<br> prior to the first study vaccine administration (Day 1).
<br>
<br> - Participant has received any other SARS-CoV-2 vaccine or experimental coronavirus
<br> vaccine at any time prior to t | | COVID-19 | Biological: COVIDITY administered via needle-free injection (PharmaJet Tropis®; intradermal injection).;Biological: COVIDITY administered via needle-free injection (PharmaJet Stratis®; intramuscular injection). | Safety and tolerability of COVIDITY as assessed by the recording of adverse events (AEs);Safety and tolerability of COVIDITY as assessed by the recording of vital signs;Safety and tolerability of COVIDITY as assessed by the recording of vital signs;Safety and tolerability of COVIDITY as assessed by the recording of vital signs;Safety and tolerability of COVIDITY as assessed by the recording of vital signs;Safety and tolerability of COVIDITY as assessed by a physical examination of the participant;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by the onset of any new chronic medical conditions;Safety and tolerability of COVIDITY as assessed by local and systemic reactogenicity events;Safety and tolerability of COVIDITY as assessed by 12-lead electrocardiogram (ECG);Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers;Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers;Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers;Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology→Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by haematology;Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers;Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers;Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers;Safety and tolerability of COVIDITY as assessed by coagulation parameters and biomarkers;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by urinalysis;Safety and tolerability of COVIDITY as assessed by 12-lead electrocardiogram (ECG);Safety and tolerability of COVIDITY as assessed by local and systemic reactogenicity events;Safety and tolerability of COVIDITY as assessed by the onset of any new chronic medical conditions;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by serum chemistry;Safety and tolerability of COVIDITY as assessed by a physical examination of the participant;Safety and tolerability of COVIDITY as assessed by the recording of vital signs;Safety and tolerability of COVIDITY as assessed by the recording of vital signs;Safety and tolerability of COVIDITY as assessed by the recording of vital signs;Safety and tolerability of COVIDITY as assessed by the recording of vital signs;Safety and tolerability of COVIDITY as assessed by the recording of adverse events (AEs) | | | | Yes | False | | |
| NCT05052294 | 18 October 2021 | COVID-19 Antibody Responses in Cystic Fibrosis | COVID-19 Antibody Responses In Cystic Fibrosis: CAR-CF | CAR-CF | University Hospital, Motol | 21/09/2021 | 20210921 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05052294 | Recruiting | No | N/A | N/A | All | September 13, 2021 | 50 | Observational | | | Czechia | ; | Pavel Drevinek, MD;Alena Bilkova, MSc | | pavel.drevinek@lfmotol.cuni.cz;alena.bilkova@lfmotol.cuni.cz | +42022443;+42022443 | |
<br> Inclusion Criteria:
<br>
<br> - Consenting people with cystic fibrosis of any age, genotype, transplant status and
<br> disease severity
<br>
<br> Exclusion Criteria:
<br>
<br> - Refusal to give informed consent
<br>
<br> - Contraindication to venepuncture.
<br> | | Cystic Fibrosis | | Longitudinal comparison of the detection;Association of SARS-CoV-2 seropositivity, clinical symptoms and clinical outcomes in pwCF;SARS-COV-2 seroprevalence | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| EUCTR2021-002530-17-PL | 18 October 2021 | A Phase 3 study, blinded in vaccinated and unvaccinated adults to determine the safety and immune response of AZD2816, a vaccine for the prevention of COVID-19 caused by variant strains | A Phase II/III Partially Double-Blinded, Randomised, Multinational, Active-Controlled Study in Both Previously Vaccinated and Unvaccinated Adults to Determine the Safety and Immunogenicity of AZD2816, a Vaccine for the Prevention of COVID-19 Caused by Variant Strains of SARS-CoV-2 | | AstraZeneca AB | 28/06/2021 | 20210628 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-002530-17 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 14/07/2021 | 2475 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: <br>Number of treatment arms in the trial: 8<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| United Kingdom;South Africa;Poland;Brazil | Information Center | | N/A | information.center@astrazeneca.com | | AstraZeneca AB | Inclusion criteria: <br>1 Adult, = 18 years of age at the time of consent<br><br>For inclusion in the SARS-CoV-2 seronegative population:<br><br>2 No history of laboratory-confirmed SARS-CoV-2 infection (ie, no positive nucleic acid<br>amplification test and no positive antibody test).<br>3 Seronegative for SARS-CoV-2 at screening (lateral flow test to detect reactivity to the<br>nucleoprotein).<br>4 Medically stable such that, according to the judgment of the investigator, hospitalization<br>within the study period is not anticipated and the participant appears likely to be able to<br>remain on study through the end of protocol-specified follow-up<br>5 Able to understand and comply with study requirements/procedures (if applicable, with<br>assistance by caregiver, surrogate, or legally authorized representative) based on the<br>assessment of the investigator<br>6 Signed informed consent obtained before conducting any study-related procedures<br>7 Contraceptive use by women should be consistent with local regulations regarding the<br>methods of contraception for those participating in clinical studies.<br><br>Previously COVID-19 Vaccinated Participants<br>8 Prior completion of a 2-dose primary homologous vaccination regimen against SARSCoV-<br>2 with either AZD1222 (2 standard doses as authorized vaccine or as investigational<br>product in a clinical trial with a 4 to 12-week dosing interval) or with an mRNA vaccine<br>approved for emergency or conditional use (eg, BNT162b2 vaccine [Pfizer-BioNTech]<br>with a 3- to 12-week dosing interval or mRNA-1273 vaccine [Moderna] with a 4- to 12-<br>week dosing interval). The second dose in all cases should have been administered at<br>least 3 months prior to first administration of study intervention.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 1975<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 500<br> | Exclusion criteria: <br>1 History of allergy to any component of AZD1222/AZD2816.<br>2 History of Guillain-Barré syndrome, any demyelinating disease, or any other neuroimmunologic condition<br>3 Significant infection or other acute illness, including fever > 100 °F (> 37.8 °C) on the day prior to or day of randomization<br>4 Any confirmed or suspected immunosuppressive or immunodeficient state, including asplenia or HIV/AIDS.<br>5 Recurrent severe infections and use of immunosuppressant medication within the past 6 months (= 20 mg per day of prednisone or its equivalent, given daily or on alternate<br>days for = 15 days within 30 days prior to administration of study intervention). The following exceptions are permitted: Topical/inhaled steroids or short-term oral steroids (course lasting = 14 days)<br>6 History of primary malignancy (see protocol)<br>7 History of thrombocytopenia and/or thrombosis, including participants who have experienced major venous and/or arterial thrombosis in combination with thrombocytopenia following vaccination with any COVID-19 vaccine<br>8 History of heparin-induced thrombocytopenia, congenital thrombophilia (ie, factor V Leiden, prothrombin G20210A, antithrombin III deficiency, protein C deficiency and protein S deficiency, factor XIII mutation, familial dysfibrinogenemia), auto-immune thrombophilia (antiphospholipid syndrome, anti-cardiolipin antibodies, anti-ß2- glycoprotein 1 antibodies), or paroxysmal nocturnal haemoglobinuria. <br>9 Clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet disorder),<br>or prior history of significant bleeding or bruising following intramuscular injections or venepuncture<br>10 Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal<br>disease, liver disease, renal disease, endocrine disorder, or neurological illness, as judged<br>by the Investigator (note, mild/moderate well-controlled comorbidities are allowed)<br>11 Any other significant disease, disorder, or finding that may significantly increase the risk to the participant because of participation in the study, affect the ability of the participant to participate in the study, or impair interpretation of the study data<br>12 Any autoimmune conditions, except mild psoriasis and vitiligo<br> | SARS-COV-2 infection (COVID-19) <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Trade Name: Vaxzevria<br>Product Code: AZD1222<br>Pharmaceutical Form: Solution for injection<br>CAS Number: 2420395-83-9<br>Current Sponsor code: AZD1222<br>Other descriptive name: ChAdOx1 nCoV-19<br>Concentration unit: Other<br>Concentration type: equal<br>Concentration number: 1 x E11-<br><br>Product Code: AZD2816<br>Pharmaceutical Form: Solution for injection<br>Current Sponsor code: AZD2816<br>Other descriptive name: ChAdOx-nCoV19<br>Concentration unit: Other<br>Concentration type: not less then<br>Concentration number: 1 x E11-<br><br> | Timepoint(s) of evaluation of this end point: for 7 and 28 days post-dose;Primary end point(s): Previously vaccinated seronegative and unvaccinated seronegative participants:<br>- Incidence of local and systemic solicited AEs for 7 days post-dose<br>- Incidence of unsolicited AEs, including MAAEs, SAEs, and AESIs, for 28 days post-dose<br>- The change from baseline for safety laboratory measures for 28 days post-dose<br><br>Immunogenicity objectives:<br>- Magnitude of SARS-CoV-2 specific antibody binding and neutralization titres (geometric mean<br>titre) <br>- Seroresponse rate of SARS-CoV-2 specific antibody binding and neutralization titres;Secondary Objective: for previously vaccinated seronegative participants:<br>- To characterize the safety and tolerability of 1 dose of AZD1222 in seronegative participants<br>previously vaccinated with AZD1222 or a SARS-CoV2 mRNA vaccine <br>(see more in protocol)<br><br>for unvaccinated seronegative participants:<br>- To characterize the safety and tolerability of a 2-dose primary vaccination with AZD1222 with a 4-week dosing interval in unvaccinated seronegative participants<br>- To characterize the safety and tolerability of a heterologous 2-dose primary vaccination with 1 dose of AZD1222 followed by 1 dose of AZD2816 administered with a 4 week dosing interval in unvaccinated seronegative participants<br>-To characterize the safety and tolerability of a 2-dose primary vaccination with AZD2816 with a<br>12-week dosing interval in unvaccinated seronegative participants<br>(see more in protocol)<br><br>Immunogenicity objectives: see protocol;Main Objective: for previously vaccinated seronegative participants:<br>To characterize the safety and tolerability of 1 dose of AZD2816 in seronegative participants<br>previously vaccinated with AZD1222<br><br>for unvaccinated seronegative participants:<br>To characterize the safety and tolerability of a 2-dose primary vaccination with AZD2816 with a<br>4-week dosing interval in unvaccinated seronegative participants<br><br>Immunogenicity objectives: see protocol | | | | Yes | False | | |
| → | EUCTR2021-004558-44-NL | 18 October 2021 | Optimal Booster Strategy for SARS-CoV-2 Vaccination in Kidney Transplant patients | Optimal Booster Strategy for SARS-CoV-2 Vaccination in Kidney Transplant patients - Recovac booster study | | UMCG | 13/09/2021 | 20210913 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-004558-44 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 10/10/2021 | 460 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 5<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Netherlands | JSF Sanders | | Hanzeplein 1 | j.sanders@umcg.nl | | UMCG | Inclusion criteria: <br>1. Age 18 years or older<br>2. Received 2 doses of mRNA-1273 according to the recommended vaccination schedule, with the last administration within the last nine months<br>3. Insufficient response to vaccination, defined as anti-spike IgG in serum < 10 BAU/mL measured between 25 and 56 days after the second dose of the mRNA-1273 vaccine with a validated test<br>4. Eligible for COVID-19 vaccination as described by the instructions of the manufacturers of the vaccine (Moderna and Janssen)<br>5. Capable of understanding the purpose and risks of the study, fully informed and given written informed consent (signed informed consent form has been obtained)<br>6. Willing to adhere to the protocol and be available during the study period<br><br>Additional inclusion criteria to be eligible for stratum A:<br>7. Maintenance immunosuppressive therapy consisting of a calcineurin inhibitor (tacrolimus or cyclosporine), MMF/MPA, and prednisone<br>8. In case of tacrolimus treatment: last tacrolimus pre-dose level while on current dosage above 4 µg/l<br>9. In case of cyclosporine treatment: last cyclosporine pre-dose level while on current dosage above 75 µg/l<br>10. Prednisone dose at least 5 mg/day<br>11. First or second transplantation<br>12. Calculated level of panel reactive antibodies prior to last transplantation below 85%<br>13. No signs of acute rejection during the preceding year<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 400<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 60<br> | Exclusion criteria: <br>1. Multi-organ transplant recipient<br>2. History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g. anaphylaxis) to any component of the study intervention(s).<br>3. Previous or active COVID-19 disease<br>4. Active malignancy, except non-melanoma skin cancer<br>5. Inherited immune deficiency<br>6. Infection with Human Immunodeficiency Virus (HIV)<br>7. Administration of T cell, B cell, or plasma cell depleting antibodies during the last 6 months<br>8. Any vaccination within a month before enrolment<br>9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.<br> | COVID-19 is associated with severely increased morbidity and mortality in kidney transplant patients. Available data show that the immune response after a standard regimen of two mRNA vaccinations is severely attenuated in kidney transplant patients compared to controls, especially when their immunosuppressive regimen contains mycophenolate mofetil (MMF) / mycophenolic acid (MPA). <br>MedDRA version: 23.1
Level: LLT
Classification code 10084401
Term: COVID-19 respiratory infection
System Organ Class: 100000004862
<br>MedDRA version: 23.1
Level: LLT
Classification code 10084464
Term: COVID-19 immunization
System Organ Class: 100000004865
<br>MedDRA version: 23.1
Level: LLT
Classification code 10084465
Term: COVID-19 vaccination
System Organ Class: 100000004865
<br>MedDRA version: 23.1
Level: LLT
Classification code 10084508
Term: COVID-19 antibody test
System Organ Class: 10022891 - Investigations
<br>MedDRA version: 20.0
Level: PT
Classification code 10023439
Term: Kidney transplant rejection
System Organ Class: 10021428 - Immune system disorders
<br>MedDRA version: 20.0
Level: LLT
Classification code 10023438
Term: Kidney transplant
System Organ Class: 100000004865
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084270
Term: SARS-CoV-2 acute respiratory disease
System Organ Class: 100000004862
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084272
Term: SARS-CoV-2 infection
System Organ Class: 100000004862
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084462
Term: SARS-CoV-2 vaccination
System Organ Class: 100000004865
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084463
Term: SARS-CoV-2 immunisation
System Organ Class: 100000004865
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084466
Term: SARS-CoV-2 immunization
System Organ Class: 100000004865
<br>MedDRA version: 23.1
Level: PT
Classification code 10084501
Term: SARS-CoV-2 antibody test
System Organ Class: 10022891 - Investigations
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Trade Name: Spikevax<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: INN-COVID-19 mRNA Vaccine<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: mg/g milligram(s)/gram<br>Concentration type: equal<br>Concentration number: 0.10-<br><br>Trade Name: Spikevax<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: INN-COVID-19 mRNA Vaccine<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 0.10-<br><br>Trade Name: COVID-19 Vaccine Janssen<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: Ad26.COV2-S recombinant<br>Other descriptive name: COVID-19 Vaccine Janssen (Ad26.COV2.S)<br>Concentration unit: Infectious unit<br>Concentration type: equal<br>Concentration number: 831763771-<br><br> | Primary end point(s): The primary endpoint is the percentage of subjects with a serum anti-S1 IgG concentration =10 BAU/mL at 28 days after the third vaccine administration.;Main Objective: To assess the immunogenicity (expressed as percentage of responders) of various COVID-19 booster vaccination strategies in kidney transplant patients that failed to mount a sufficient antibody response after two primary doses of the mRNA-1273 vaccine.;Secondary Objective: - To measure the concentration of SARS-CoV-2 spike S1-specific IgG antibodies in serum at 28 days after the 3rd vaccine administration<br>- To assess the durability of the SARS-CoV-2 spike S1-specific IgG antibody response at 6 and 12 months after the 3rd vaccine administration<br>- To measure the presence and titer of neutralizing anti-SARS-CoV-2 antibodies after booster vaccination<br>- To evaluate SARS-CoV-2 specific T cell responses<br>- To measure anti-S1 antibody (IgG and IgA) responses and neutralizing capacity of these antibodies in nasal mucosal fluid<br>- To evaluate vaccine safety in terms of incidence of solicited local and systemic adverse events (AEs) graded according to severity, including the incidence of acute rejections within 6 months after the third vaccination .;Timepoint(s) of evaluation of this end point: 28 days after the third (and possibly a fourth) vaccination→Timepoint(s) of evaluation of this end point: 28 days after the third (and possibly a fourth) vaccination;Primary end point(s): The primary endpoint is the percentage of subjects with a serum anti-S1 IgG concentration =10 BAU/mL at 28 days after the third vaccine administration.;Main Objective: To assess the immunogenicity (expressed as percentage of responders) of various COVID-19 booster vaccination strategies in kidney transplant patients that failed to mount a sufficient antibody response after two primary doses of the mRNA-1273 vaccine.;Secondary Objective: - To measure the concentration of SARS-CoV-2 spike S1-specific IgG antibodies in serum at 28 days after the 3rd vaccine administration<br>- To assess the durability of the SARS-CoV-2 spike S1-specific IgG antibody response at 6 and 12 months after the 3rd vaccine administration<br>- To measure the presence and titer of neutralizing anti-SARS-CoV-2 antibodies after booster vaccination<br>- To evaluate SARS-CoV-2 specific T cell responses<br>- To measure anti-S1 antibody (IgG and IgA) responses and neutralizing capacity of these antibodies in nasal mucosal fluid<br>- To evaluate vaccine safety in terms of incidence of solicited local and systemic adverse events (AEs) graded according to severity, including the incidence of acute rejections within 6 months after the third vaccination . | | | | Yes | False | | |
| EUCTR2020-002249-40-BG | 18 October 2021 | Cure COVID: A study to compare the efficacy of GNS561 versus standard treatments in patients with SARS-CoV-2 (COVID-19) infection. | Cure COVID: A prospective, controlled, randomized study to compare the efficacy of GNS561 versus standard of care in patients with SARS-CoV-2 (COVID-19) infection. | | Genoscience Pharma | 18/08/2021 | 20210818 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002249-40 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 06/10/2021 | 120 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: standard of care<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Bulgaria;France | Clinical trials information | | 10 rue d'Iéna | contact@genosciencepharma.com | 330491 26 99 50 | Genoscience Pharma | Inclusion criteria: <br>1. Age 18 or older at the time of enrolment.<br>2. Documented diagnosis of COVID-19 (diagnostic test performed in a certified laboratory) which is preferable. However if limited access to the test, symptoms of COVID-19 associated with “lung imaging findings” on chest CT scan: unilateral or bilateral ground-glass opacities and/or consolidation. <br>3. Clinical status: News2 score from 5 to 6.<br>4. Adequate bone marrow and end-organ function defined by the following laboratory results:<br>• Bone marrow: <br>- Hemoglobin = 7.0 g/dL, <br>- Absolute Neutrophils Count (ANC) = 1.0 Gi/L, <br>- Platelets = 100 Gi/L;<br>• Hepatic function:<br>- Total serum bilirubin = 1.5 x ULN (except patients with Gilbert’s syndrome who must have total serum bilirubin = 3.0 x ULN), <br>- AST and ALT = 5 ULN<br>• Renal function:<br>- Serum creatinine = 2.0 x ULN or Cr. Cl. = 30ml/min/1.73m² (MDRD or CKD-EPI formula);<br>5. Willingness and ability to comply with the study requirements;<br>6. Signed and dated informed consent indicating that the patient has been informed of all the aspects of the trial prior to enrolment;<br>7. Women of childbearing potential are required to have a negative serum pregnancy test within 72 hours prior to study treatment start. A positive urine test must be confirmed by a serum pregnancy test;<br>8. Women of childbearing potential and male patients must agree to use adequate highly effective contraception for the duration of study participation and up to 6 months following completion of therapy;<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 70<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 50<br> | Exclusion criteria: <br>1. Patient known to have intolerance or hypersensitivity to chloroquine or any quinoline derivates (quinine, chloroquine, tafenoquine, hydroxychloroquine, mefloquine).<br>2. Patient requires the use of one of the following forbidden treatment during the study treatment period: <br>• Major surgery.<br>• Live vaccines. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever and BCG. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however intranasal influenza vaccines (Flu-Mist®) are live attenuated vaccines, and are not allowed.<br>3. Any clinically significant cardiovascular condition as judged by the Investigator, like uncontrolled blood pressure, unstable angina, history of myocardial infraction within 6 months, clinically significant peripheral vascular disease<br>4. Known hepatitis B, treated or not, with viral load < 20 UI/mL or Human Immunodeficiency Virus (HIV) infection, with negative viral load and CD4 > 250/mm3, in last 3 months.<br>5. Prior allogeneic bone marrow transplantation or solid organ transplant in the past.<br>6. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator. <br>7. Pregnant or breastfeeding patient, or expecting to conceive children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of study drugs.<br> | COVID-19 infection <br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Code: GNS561<br>Pharmaceutical Form: Capsule, hard<br><br> | Timepoint(s) of evaluation of this end point: Day 7;Primary end point(s): Loss of one grade of NEWS2 score at day-7: from medium stage at baseline, to low grade at day-7;Secondary Objective: The secondary objectives will be to evaluate in each arm of the study:<br>- the safety of GNS561 in patients with COVID-19 infection.<br>- the efficacy of GNS561 in viral replication<br>- the efficacy of GNS561 on immunity of patients to fight the virus<br>- the efficacy of GNS561 on the inflammatory reaction induced in patients<br>;Main Objective: To evaluate the efficacy of GNS561 in patients with Covid-19 infection versus standard of care | | | | Yes | False | | |
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| EUCTR2021-001036-25-DE | 18 October 2021 | Study to test UNI91103 in adults with Covid-19 and no or only mild symptoms | A RANDOMIZED PLACEBO-CONTROLLED PHASE 2 STUDY TO ASSESS THE SAFETY AND EFFICACY OF UNI91103 INTRANASAL ADMINISTRATION IN ADULTS WITH ASYMPTOMATIC OR MILDLY SYMPTOMATIC COVID-19 | | UNION therapeutics A/S | 01/04/2021 | 20210401 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-001036-25 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 01/06/2021 | 330 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany | Sr Director Clinical Operations | | Tuborg Havnevej 18 | asger.bering.kristensen@uniontherapeutics.com | +45619111065 | UNION therapeutics A/S | Inclusion criteria: <br>1. The subject is male or female aged = 45 years.<br>2. The subject is able to understand and provide signed informed consent.<br>3. The subject is tested to confirm infection with SARS-CoV-2 by lateral flow antigen test or RT-PCR on a sample taken within 3 days before randomization.<br>4. The subject is either without symptoms or has one or more of the following symptoms: stuffy or runny nose, sore throat, loss of taste, loss of smell, or headache (to be entered in the FDA COVID-19 questionnaire). Conjunctivitis is also acceptable. None of the symptoms should have been present > 5 days.<br>5. Men whose sexual partners are women of childbearing potential (WOCBP) must agree to comply with one of the following contraception requirements from the time of first dose of screening until at least 30 days after the last dose of study medication:<br>a. Vasectomy with documentation of azoospermia.<br>b. Sexual abstinence (defined as refraining from heterosexual intercourse from the time of screening until at least 30 days after the last dose of study medication)<br>c. Male condom plus partner use of one of the contraceptive options below: contraceptive subdermal implant; intrauterine device of intrauterine system; oral contraceptive, either combine or progestogen alone; injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches. <br>The above is an all-inclusive list of those methods that meet the following definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. For non-product methods (e.g., male sterility), the investigatory will determine what is consistent and correct use. The investigator is responsible for ensuring that patients understand how to properly use these methods of contraception. <br>6. WOCBP must agree to comply with one of the following contraception requirements from the time of screening until at least 30 days after the last dose of study medication: <br>a. Sexual abstinence (defined as refraining from heterosexual intercourse from the time of screening until at least 30 days after the last dose of study medication).<br>b. Use of one of the contraceptive options below plus use of a condom by male partner: contraceptive subdermal implant; intrauterine device or intrauterine system; oral contraceptive, either combined or progestogen alone; injectable progestogen; contraceptive vaginal ring; percutaneous contraceptive patches. <br>c. Vasectomy of male partner with documentation of azoospermia. <br>The above is an all-inclusive list of those methods that meet the following definition of highly effective: having a failure rate of less than 1% per year when used consistently and correctly and, when applicable, in accordance with the product label. The investigator is responsible for ensuring that patients understand how to properly use these methods of contraception. Women of non-reproductive potential are defined as: a) Premenopausal females with one of the following: documented tubal ligation; documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; hysterectomy; documented bilateral oophorectomy. b) Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample will be required with simultaneous follicle stimulating hormone and estradiol levels tested locally and consistent with menopause [refer to local laboratory reference ranges | Exclusion criteria: <br>1. The subject has been enrolled in a study with niclosamide in the previous 6 months. <br>2. The subject is allergic to niclosamide or history of significant adverse reaction to niclosamide or related compounds, or to any of the excipient used. <br>3. The subject has an underlying condition that may interfere with intranasal administration of the investigational medicinal product (IMP), for example chronic ulcer(s) in the nose. <br>4. The subject has an acute or chronic condition that, as judged by the investigator, would jeopardize the safety of the participant. <br>5. The subject has a condition the investigator believes would interfere with the ability to provide consent, or comply with study instructions, or that might confound the interpretation of the study results. <br>6. 6. Subjects with symptoms suggesting engagement of the lower respiratory tract or a systemic engagement such as cough, feeling feverish, chills, shivering, feeling hot, low energy, tiredness, body aches and pains, fatigue, shortness of breath, loss of appetite, nausea, vomiting, or diarrhea (to be entered in the FDA COVID-19 questionnaire), or other symptoms not mentioned in inclusion criteria 5. <br>7. The subject has an active or acute infection other than SARS-CoV-2.<br>8. The subject has used other investigational products the month prior to Day 1. <br>9. Antiviral medications and approved or experimental medications targeting COVID-19. <br>10. Another member of the same household recruited to this study.<br><br> | Covid-19 <br>MedDRA version: 23.1
Level: LLT
Classification code 10084401
Term: COVID-19 respiratory infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Niclosamide<br>Product Code: Niclosamide<br>Pharmaceutical Form: Nasal spray, solution<br>INN or Proposed INN: Niclosamide Ethanolamine<br>CAS Number: 1420-04-8<br>Current Sponsor code: UNI911<br>Other descriptive name: UNI911<br>Concentration unit: ml millilitre(s)<br>Concentration type: equal<br>Concentration number: 20-<br>Pharmaceutical form of the placebo: Nasal spray, solution<br>Route of administration of the placebo: Nasal use<br><br> | Timepoint(s) of evaluation of this end point: as defined in the end point and according to protocol assessments;Primary end point(s): Change from baseline in symptoms through Day 10 defined as aggregated Food and Drug Administration (FDA) COVID-19 questionnaire score from baseline through Day 10 comparing UNI91103 vs placebo. <br>Safety of UNI91103 nasal spray as assessed by adverse events, vital signs, hematology, and clinical chemistry<br><br>;Secondary Objective: To assess the efficacy of UNI91103 on development of symptoms of COVID-19<br>To assess UNI91103 on severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) on viral load <br>To assess the effect of UNI91103 on the spread of COVID-19 from the index case<br>;Main Objective: To assess the efficacy of UNI91103 to prevent disease progression<br>To assess the safety of UNI91103<br> | | | | Yes | True | parent | |
| → | EUCTR2020-003770-50-CZ | 18 October 2021 | An Open-Label, Single/Multiple Ascending Dose Study to Assess the Pharmacokinetics, Efficacy, Safety and Tolerability of Inhalation Delivery of Hydroxychloroquine Sulfate (HCQ) in Healthy Volunteers and patients with COVID-19 | An Open-Label, Single/Multiple Ascending Dose Study to Assess the Pharmacokinetics, Efficacy, Safety and Tolerability of Inhalation Delivery of Hydroxychloroquine Sulfate (HCQ) in Healthy Volunteers and patients with COVID-19 | | Všeobecná fakultní nemocnice v Praze | 09/09/2020 | 20200909 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-003770-50 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 13/10/2021 | 137 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: yes<br>Other trial design description: dose escalation study<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: standard of care<br>Number of treatment arms in the trial: 5<br> | Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Czech Republic | Ondrej Slanar | | Albertov 4 | | +420224968146 | General University Hospital in Prague | Inclusion criteria: <br>Inclusion criteria healthy subjects<br>1. Healthy male volunteers = 18 and = 55 years old (date of ICF signature is decisive). <br>2. Non-smoker or past-smoker (who has stopped smoking at least 6 months before the first dosing).<br>3. Body Mass Index at screening = 18.5 and = 30.0 kg/m2.<br>4. Subject is available for the whole study and has provided his written informed consent.<br>5. With clinical history and physical examination results within normality.<br>6. All laboratory screening results within the normal range or deemed clinically insignificant by Investigator. <br>7. Acceptance of use of effective contraceptive measures during the whole study. <br>8. Screening Vital signs and ECG without significant deviations.<br>9. Czech citizenship.<br><br>Inclusion criteria COVID-19 patients<br>1. Study subjects must be =18 years inclusive (male or female)<br>2. Hospitalized or admitted patients to hospital with COVID-19 pneumonia or respiratory symptoms confirmed with positive PCR or antigen test for SARS-CoV-2 virus<br>3. Moderate to severe disease with or without supplemental oxygen administration by nasal cannula, face mask and or noninvasive or mechanical ventilation (for the purpose of the study the patient conditions and treatment will be considered, please see the protocol section Study population specific information and procedures) etc <br>4. Capable of giving sSigned informed consent prior to performing study procedures (please see the protocol section Study population specific information and procedures)<br>5. For woman of childbearing potential use of contraceptive measures during the study up to follow-up call day 30 after the end of treatment and or later discharge from the hospital<br><br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 137<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>Exclusion Criteria healthy subjects<br>1. Known hypersensitivity to 4-aminoquinoline compounds and contraindication of HCQ use.<br>2. Medical history of retinal or visual field changes of any etiology.<br>3. Acute or chronic diseases and/or clinical findings e.g. several renal or liver impairment, which may interfere with the aims of the study or with the bioavailability and/or pharmacokinetics of the IMP.<br>4. Medical history of asthma bronchiale or bronchospasms or any allergies deemed clinically significant by Investigator.<br>5. Clinically significant illness within 4 weeks before the first dosing, including major surgery.<br>6. Vaccination with live vaccines less than 14 days prior to the first administration of IMP.<br>7. Use of an investigational drug within 2 months prior to dosing in this study.<br>8. Use of HCQ within 3 months prior to dosing in this study.<br>9. Any clinically significant laboratory abnormality, including positive results of HBsAg and/or HCV and/or HIV test during screening procedure.<br>10. Prolonged QT interval at baseline or at increased risk for arrhythmia.<br>11. Positive alcohol breath test.<br>12. Positive urinary drug screen test at check-in.<br>13. Serious mental disease or inability to cooperate with clinical team. <br>14. Sitting blood pressure is out of the range of 90 - 140 mmHg for systolic BP and/or 60-90 mmHg for diastolic BP and/or heart rate out of the range of 50-100 bpm at screening.<br>15. Body temperature <35.7 and/or >37.2°C at screening or baseline.<br>16. History of substance abuse including alcohol.<br>17. Donation or loss of = 500 mL of blood within 90 days prior to the first dosing. <br>18. Donation of plasma or platelets within 14 days prior to the first dosing.<br>19. Haemoglobin below 120 g/L for women and 130 g/L for men at Screening.<br>20. Leukocytosis, level of leukocytes above 9.00 * 109/L at Screening.<br>21. All prescription, over-the-counter and herbal medications are prohibited within 10 days prior to study dosing (with exception of paracetamol =1000 mg/day at the discretion of the Investigator).<br>22. Subject is not willing to keep contraceptive requirements (set in Inclusion criteria).<br>23. Employees of the Study Centers, Study personnel and relatives of study personnel<br><br>Exclusion Criteria COVID-19 patients<br>1. Presence of retinal or visual field changes of any etiology<br>2. Known hypersensitivity to 4-aminoquinoline compounds and contraindication of HCQ or present peroral HCQ use<br>3. Prolonged QT interval at baseline or at increased risk for arrythmia<br>4. Use of HCQ contraindicated medications (e.g. citalopram)<br>5. Multi-organ system dysfunction as judged by the investigator to be of clinical relevance<br>6. Elevated liver enzymes or judged by the investigator to be of clinical relevance<br>7. Exclusion of patients with hypokalemia/hypomagnesemia<br>8. Sever renal impairment as judged by the investigator to be of clinical relevance<br>9. Medical history of asthma bronchiale or bronchospasms or any allergies deemed clinically significant by Investigator<br>10. Participation of study subject in any concurrently ongoing clinical investigation for COVID-19 treatment which could interfere with the study outcome<br>11. Pregnancy and breast feeding.<br>12. Employees of the Study Centers, Study personnel and relatives of study personnel<br><br><br><br> | Healthy volunteers and patients with COVID - 19 <br>MedDRA version: 23.0
Level: HLT
Classification code 10084510
Term: Coronavirus infections
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Hydroxychloroquine Sulfate Solution for Nebulization <br>Pharmaceutical Form: Inhalation solution<br>INN or Proposed INN: Hydroxychloroquine<br>CAS Number: 118-42-3<br>Concentration unit: % (W/V) percent weight/volume<br>Concentration type: range<br>Concentration number: 0.33-0.67<br><br> | Primary end point(s): Healthy: pharmacokinetics of hydroxychloroquine sulfate following inhalation delivery in an ascending dosing scheme <br>Patients: Evaluation of efficacy, safety and tolerability of hydroxychloroquine sulfate following inhalation delivery of HCQ combined with standard of care versus standard of care only using oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) considering:<br>• Change in SpO2/FiO2 ratio from baseline versus Day 7 or at release<br>• Time to saturation =92% on room air<br>• Duration of supplemental oxygen use<br>• Time to fever resolution<br>• Number of days without fever <br>• X ray lungs – prior to the start of the therapy and at release (number of affected segments)<br>• Change in quantitative SARS-CoV-2 virus evaluation prior start of the therapy or Day 1, and at release (nasal swab/BAL/ELF and blood)<br>• Time to progression to noninvasive or invasive mechanical ventilation or ECMO in patients on oxygen or high flow nasal oxygen (HFNO)<br>• Time to weaning from noninvasive or invasive mechanical ventilation or ECMO in the patients on MV or ECMO<br>• Time to release from the hospital<br>• Mortality<br>• Evaluation of complement plasma levels<br>;Timepoint(s) of evaluation of this end point: Healthy subjects: 5 days<br>Patients: discharge from hospital;Main Objective: • Assessment of pharmacokinetics of single dose hydroxychloroquine sulfate following inhalation delivery in an ascending dosing scheme.<br>• Population pharmacokinetics after multiple dose administration<br>;Secondary Objective: • Evaluation of efficacy, safety and tolerability of multiple dose hydroxychloroquine sulfate following inhalation delivery of HCQ combined with standard of care versus standard of care only using oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) considering:<br>• Change in SpO2/FiO2 ratio from baseline versus Day 7 or at release<br>• Time to saturation =92% on room air<br>• Duration of supplemental oxygen use<br>• Time to fever resolution<br>• Number of days without fever <br>• X ray lungs – prior to the start of the therapy and at release (number of affected segments)<br>• Change in quantitative SARS-CoV-2 virus evaluation prior start of the therapy orand Day 1, and at release (nasal swab/BAL/ELF and blood)<br>• Time to progression to noninvasive or invasive mechanical ventilation or ECMO in patients on oxygen or high flow nasal oxygen (HFNO)<br>• Time to weaning from noninvasive or invasive mechanical ventilation or ECMO in the patients on MV or ECMO<br>• Time to release from the hospital<br>• Mortality→Timepoint(s) of evaluation of this end point: Healthy subjects: 5 days<br>Patients: discharge from hospital;Primary end point(s): Healthy: pharmacokinetics of hydroxychloroquine sulfate following inhalation delivery in an ascending dosing scheme <br>Patients: Evaluation of efficacy, safety and tolerability of hydroxychloroquine sulfate following inhalation delivery of HCQ combined with standard of care versus standard of care only using oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) considering:<br>• Change in SpO2/FiO2 ratio from baseline versus Day 7 or at release<br>• Time to saturation =92% on room air<br>• Duration of supplemental oxygen use<br>• Time to fever resolution<br>• Number of days without fever <br>• X ray lungs – prior to the start of the therapy and at release (number of affected segments)<br>• Change in quantitative SARS-CoV-2 virus evaluation prior start of the therapy or Day 1, and at release (nasal swab/BAL/ELF and blood)<br>• Time to progression to noninvasive or invasive mechanical ventilation or ECMO in patients on oxygen or high flow nasal oxygen (HFNO)<br>• Time to weaning from noninvasive or invasive mechanical ventilation or ECMO in the patients on MV or ECMO<br>• Time to release from the hospital<br>• Mortality<br>• Evaluation of complement plasma levels<br>;Main Objective: • Assessment of pharmacokinetics of single dose hydroxychloroquine sulfate following inhalation delivery in an ascending dosing scheme.<br>• Population pharmacokinetics after multiple dose administration<br>;Secondary Objective: • Evaluation of efficacy, safety and tolerability of multiple dose hydroxychloroquine sulfate following inhalation delivery of HCQ combined with standard of care versus standard of care only using oxygen saturation/fraction of inspired oxygen (SpO2/FiO2) considering:<br>• Change in SpO2/FiO2 ratio from baseline versus Day 7 or at release<br>• Time to saturation =92% on room air<br>• Duration of supplemental oxygen use<br>• Time to fever resolution<br>• Number of days without fever <br>• X ray lungs – prior to the start of the therapy and at release (number of affected segments)<br>• Change in quantitative SARS-CoV-2 virus evaluation prior start of the therapy orand Day 1, and at release (nasal swab/BAL/ELF and blood)<br>• Time to progression to noninvasive or invasive mechanical ventilation or ECMO in patients on oxygen or high flow nasal oxygen (HFNO)<br>• Time to weaning from noninvasive or invasive mechanical ventilation or ECMO in the patients on MV or ECMO<br>• Time to release from the hospital<br>• Mortality | | | | Yes | False | | |
| EUCTR2021-000307-20-DE | 18 October 2021 | Tracking the immune response to SARS-CoV-2 modRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c. (KYRIOS) | Tracking the immune response to SARS-CoV-2 modRNA vaccines in an open-label multicenter study in participants with relapsing multiple sclerosis treated with ofatumumab s.c. (KYRIOS) | | Novartis Pharma Vertriebs GmbH | 12/02/2021 | 20210212 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000307-20 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 28/04/2021 | 40 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: RNA vaccination as part of clinical routine before starting Ofatumumab (OMB157) treatment<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Germany | Medizinischer Infoservice (MCC) | | Roonstrasse 25 | infoservice.novartis@novartis.com | +4991127312100 | Novartis Pharma GmbH | Inclusion criteria: <br>1. Signed informed consent must be obtained prior to participation in the study.<br>2. Patients eligible to start ofatumumab as per physician’s discretion and approved SmPC (exp. April, 2021; for cohort 2, patients may already be on ofatumumab, but most patients will start ofatumumab as part of this study).<br>3. Patients willing and eligible to receive a modRNA vaccine against SARS-CoV-2 as part of clinical routine<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 40<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>1. History of COVID-19 or current COVID-19 symptoms<br>2. Patients who previously received a BTK inhibitor or an antiCD20 therapy other than ofatumumab<br>3. Patients likely not being able or willing to complete the study<br>4. Use of other investigational drugs within 5 half-lives of enrollment/initiation of study treatment (e.g. small molecules) or until the expected pharmacodynamic effect has returned to baseline (e.g. biologics), whichever is longer<br>5. Patients with any medical or psychological condition that, in the investigators opinion, renders the patient unable to understand the nature, scope, and possible consequences of the study<br>6. No person directly associated with the administration of the study is allowed to participate as a study subject<br>7. No family member of the investigational study staff is allowed to participate in this study<br>8. No previous vaccination with a non-modRNA SARS-CoV-2 vaccine.<br> | relapsing multiple sclerosis <br>MedDRA version: 20.0
Level: PT
Classification code 10048393
Term: Multiple sclerosis relapse
System Organ Class: 10029205 - Nervous system disorders
;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | <br>Trade Name: Kesimpta<br>Product Name: Kesimpta 20 mg Injektionslösung im Fertigpen<br>Product Code: OMB157G<br>Pharmaceutical Form: Solution for injection in pre-filled pen<br>INN or Proposed INN: OFATUMUMAB<br>CAS Number: 679818-59-8<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 50-<br><br>Trade Name: Comirnaty Konzentrat zur Herstellung einer Injektionsdispersion<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: COVID-19 mRNA vaccine (nucleoside-modified)<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br>Trade Name: Spikevax<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified)<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br> | Timepoint(s) of evaluation of this end point: either one month after second dose of vaccine or one month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment;Primary end point(s): Proportion of RMS patients having established SARS-CoV-2-specific T cells as defined by detection of SARS-CoV-2 reactive T-cells, measured by e.g. enzyme-linked immunosorbent spot (ELIspot) assay from T-cells that were stimulated with SARS-CoV-2 peptide mix, either one month after second dose of vaccine or one month after booster vaccine in participants who received the respective vaccine before or after starting ofatumumab treatment (yes/no);Secondary Objective: To estimate:<br>• the proportion of RMS patients maintaining for up to 18 months SARS-CoV-2-specific T cells after receiving a modRNA vaccine either before or after starting ofatumumab treatment<br>• the proportion of RMS patients achieving seroconversion (i.e. having SARS-CoV-2 serum neutralizing antibodies) after receiving a modRNA vaccine either before or after starting ofatumumab treatment<br>• the proportion of RMS patients maintaining for up to 18 months quantifiable levels of SARS-CoV-2 serum functional antibodies after receiving a modRNA vaccine either before or after starting ofatumumab treatment<br>• the proportion of RMS patients with quantifiable SARS-CoV-2-specific T cells and functional antibodies after receiving an additional dose of modRNA vaccine (booster vaccine)<br>Describing:<br>• phenotypically the cellular response after receiving a modRNA vaccine either before or after starting ofatumumab treatment<br>• safety and tolerability, incl. patients developing coronavirus disease 2019;Main Objective: To estimate the proportion of RMS patients having established SARS-CoV-2-specific T cells after receiving a modRNA vaccine (initial vaccination cycle or<br>booster vaccine) either before or after starting ofatumumab treatment. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04317040 | 26 October 2021 | CD24Fc (MK-7110) as a Non-antiviral Immunomodulator in COVID-19 Treatment (MK-7110-007) | A Randomized, Double-blind, Placebo-controlled, Multi-site, Phase III Study to Evaluate the Safety and Efficacy of CD24Fc in COVID-19 Treatment | SAC-COVID | OncoImmune, Inc. | 19/03/2020 | 20200319 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04317040 | Not recruiting | No | 18 Years | N/A | All | April 24, 2020 | 234 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States | | Medical Director | | | | Merck Sharp & Dohme Corp. |
<br> Inclusion Criteria:
<br>
<br> - Diagnosed with coronavirus disease 2019 (COVID-19) and confirmed severe acute
<br> respiratory syndrome coronavirus 2 (SARS-coV-2) viral infection
<br>
<br> - Severe or critical COVID-19, or National Institute of Allergy and Infectious Diseases
<br> (NIAID) 8-point ordinal score 2, 3 or 4 (Scale 2: requiring invasive mechanical
<br> ventilation or extracorporeal membrane oxygenation (ECMO); Scale 3: non-invasive
<br> ventilation or high flow oxygen devices; Scale 4: supplemental oxygen support; a
<br> peripheral capillary oxygen saturation (SpO2) </= 94% or tachypnea (respiratory rate
<br> >/= 24 breaths/min). Intubation should be within 7 days
<br>
<br> Exclusion Criteria:
<br>
<br> - Participants who are pregnant, breastfeeding, or have a positive pregnancy test result
<br> before enrollment
<br>
<br> - Participants previously enrolled in the CD24Fc study
<br>
<br> - Intubation for invasive mechanical ventilation is over 7 days
<br>
<br> - Documented acute renal or hepatic failure
<br>
<br> - The investigator believes that participating in the trial is not in the best interests
<br> of the participant, or the investigator considers unsuitable for enrollment (such as
<br> unpredictable risks or subject compliance issues)
<br> | | Coronavirus Disease 2019 (COVID-19) | Drug: CD24Fc;Drug: Placebo | Time to Improvement in Coronavirus Disease 2019 (COVID-19) Clinical Status;Number of Participants Who Experience an Adverse Event (AE) | 15/10/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04317040 | Yes | False | | Yes |
| → | NCT04322513 | 26 October 2021 | Biomarkers for Identification of COVID-19 Infection | Biomarkers Identification for Diagnosis and Treatment of SARS-COV-2 Infection | B-DT-COV2 | University of Catanzaro | 23/03/2020 | 20200323 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04322513 | Recruiting | No | 14 Years | 75 Years | All | March 24, 2020 | 110 | Observational | | | Italy | ; | LUCA GALLELLI;LUCA GALLELLI | | gallelli@unicz.it;gallelli@unicz.it | 3339245656;3339245656 | |
<br> Inclusion Criteria:
<br>
<br> - Aged between 18 and 75 years, extremes included, male or female In conscious patients,
<br> ability to understand and the willingness to sign a written informed consent document;
<br> in unconscious patients informed consent will be signed from parents or legal tutors.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients that don't sign the informed consent
<br> | | Coronavirus | Diagnostic Test: Biomarkers expression | Biomarkers expression;Liver Biomarkers expression→Liver Biomarkers expression;Biomarkers expression | | | | Yes | False | | |
| NCT04333862 | 26 October 2021 | Assessment of Covid-19 Infection Rates in Healthcare Workers Using a Desynchronization Strategy | Assessment of Covid-19 Infection Rates in Healthcare Workers Using a Desynchronization Strategy | Covid-19 | University Hospital Inselspital, Berne | 01/04/2020 | 20200401 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04333862 | Not recruiting | No | 18 Years | N/A | All | March 19, 2020 | 500 | Observational | | | Switzerland | | Guido Beldi, Prof. Dr. | | | | University Hospital Inselspital, Berne |
<br> Inclusion Criteria:
<br>
<br> - Healthcare workers of the Department for Visceral Surgery and Medicine
<br>
<br> - Patients of the Department for Visceral Surgery and Medicine
<br>
<br> - Written informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - No informed consent
<br>
<br> - Patients with known COVID-19 infection before hospitalization in the investigators'
<br> department
<br> | | SARS-CoV-2 | | Fraction of healthcare workers infected with SARS-CoV-2 | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04964115 | 26 October 2021 | Post Acute Sequelae of COVID-19 | Post Acute Sequelae of SARS-CoV-2 | PASC | Vanderbilt University Medical Center | 13/05/2021 | 20210513 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04964115 | Recruiting | No | 18 Years | N/A | All | August 10, 2021 | 500 | Observational [Patient Registry] | | | United States | ; ; | Carla M Sevin, MD;Carla M Sevin, MD;Peter J Edmonds, MD | | ;carla.sevin@vumc.org;peter.j.edmonds@vumc.org | ;6153222386;625-322-2386 | Vanderbilt University Medical Center; |
<br> Inclusion Criteria:
<br>
<br> - 18 years or older
<br>
<br> - COVID-19 diagnosis
<br>
<br> - Seen in a Vanderbilt clinic or affiliated health facility
<br>
<br> Exclusion Criteria:
<br>
<br> - none
<br> | | Covid19;Sars-CoV-2 Infection;Dyspnea Caused by 2019-nCoV;COVID-19 Acute Respiratory Distress Syndrome;Pulmonary Fibrosis | Other: Cohort study | Natural history of recovery from COVID-19 | | | | Yes | False | | |
| → | NCT04978259 | 26 October 2021 | SOLIDARITY Finland Long COVID-19 | Long-term Follow-up of a Randomized Multicenter Trial on Impact of Long-COVID in Hospitalized COVID-19 Patients | | Clinical Urology and Epidemiology Working Group | 20/07/2021 | 20210720 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04978259 | Recruiting | No | 18 Years | N/A | All | July 24, 2021 | 202 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 4 | Finland | ; ; ; | Kari AO Tikkinen, MD PhD;Olli Nevalainen, MD PhD;Kari AO Tikkinen, MD PhD;Kari AO Tikkinen | | ;;kari.tikkinen@helsinki.fi;kari.tikkinen@helsinki.fi | ;;+358406510530;+358406510530 | University of Helsinki;University of Helsinki; |
<br> Inclusion Criteria:
<br>
<br> - Alive patients who attended the SOLIDARITY Finland remdesivir sub-study
<br>
<br> Eligibility criteria for SOLIDARITY Finland remdesivir -study:
<br>
<br> Inclusion criteria:
<br>
<br> - Adult patients, 18 years and older
<br>
<br> - Laboratory-confirmed SARS-CoV-2 infection
<br>
<br> - Admitted to the hospital ward or the intensive care unit (ICU)
<br>
<br> - Patient provides written informed consent prior to initiation of the study OR close
<br> relative/legal representative provides written informed consent prior to initiation of
<br> the study according to the presumed will of the patient when patient is unable to give
<br> consent.
<br>
<br> - No anticipated transfer within 72 hours to a non-study hospital
<br>
<br> Exclusion Criteria:
<br>
<br> - Severe co-morbidity with life expectancy <3 months according to investigators
<br> assessment
<br>
<br> - ASAT/ALAT > 5 times the upper limit of normal
<br>
<br> - Acute co-morbidity within 7 days before inclusion such as myocardial infarction or
<br> unstable angina pectoris (not including troponin elevation due to infection)
<br>
<br> - Pregnancy or breast feeding
<br>
<br> - Any reason why, in the opinion of the investigators, the patient should not
<br> participate
<br>
<br> - Subject participates in a potentially confounding drug or device trial during the
<br> course of the study
<br>
<br> - Already receiving the study drug
<br>
<br> - Renal failure (eGRF < 30 mL/min) or dialysis/continuous veno-venous hemofiltration
<br> | | Covid19 | Drug: Remdesivir | Quality of life (QoL);Quality of life (QoL);Long-COVID symptoms;Long-COVID symptoms→Long-COVID symptoms;Long-COVID symptoms;Quality of life (QoL);Quality of life (QoL) | | | | Yes | False | | |
| NCT05004805 | 26 October 2021 | COVID-19 Methylene Blue Antiviral Treatment | COVID-19 Methylene Blue Antiviral Treatment | COMBAT | Irkutsk Scientific Center of the Siberian Branch of the Russian Academy of Sciences | 11/08/2021 | 20210811 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05004805 | Not recruiting | No | 18 Years | N/A | All | August 6, 2021 | 24 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | Phase 2 | Russian Federation | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Men and women aged 18 and over at the time of signing the informed consent.
<br>
<br> 2. The patient is willing and able to give written informed consent to participate in the
<br> study and follow the procedures specified in the protocol.
<br>
<br> 3. Diagnosed with COVID-19, confirmed by a PCR test positive for the SARS-CoV-2
<br> coronavirus in smears from the nasopharynx and oropharynx.
<br>
<br> 4. Indications for hospitalization for COVID-19 treatment: a moderate condition that does
<br> not require oxygen support or low oxygen flow required through a nasal cannula or
<br> oxygen mask.
<br>
<br> 5. A urine test performed during screening, negative for pregnancy in women capable of
<br> childbearing.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. The need for non-invasive ventilation or high oxygen flow, or intubation of the
<br> trachea with artificial ventilation, or the use of vasopressors and/or extracorporeal
<br> membrane oxygenation at the time of assessment.
<br>
<br> 2. Decompensation of concomitant pathology, whose severity exceeds the severity of
<br> COVID-19 manifestations (for example, acute coronary syndrome, cerebral circulation
<br> disorders, acute surgical pathology requiring surgical intervention, bleeding
<br> independent of the localization, etc.).
<br>
<br> 3. Topical or systemic use of Methylene blue for any reasons at the time of evaluation or
<br> during the interval of 30 days before hospitalization.
<br>
<br> 4. Known intolerance or hypersensitivity to Methylene blue (indicated in the medical
<br> history of the patient).
<br>
<br> 5. Patients with a high probability of not surviving within the first 24 h of
<br> hospitalization, regardless of the treatment, as defined by the investigator.
<br> | | Covid19 | Drug: Methylene Blue;Drug: Saline nasal spray | Recovery;Recovery | | | | Yes | False | | |
| → | NCT05007951 | 26 October 2021 | Immunogenicity and Safety Study of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine (GBP510) Adjuvanted With AS03 (COVID-19) | A Phase III, Randomized, Active-controlled, Observer-blind, Parallel-group, Multi-center Study to Assess the Immunogenicity and Safety of SK SARS-CoV-2 Recombinant Nanoparticle Vaccine Adjuvanted With AS03 (GBP510) in Adults Aged 18 Years and Older | | SK Bioscience Co., Ltd. | 09/08/2021 | 20210809 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05007951 | Recruiting | No | 18 Years | N/A | All | August 30, 2021 | 3990 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | Vietnam;Ukraine;Thailand;Philippines;New Zealand;Korea, Republic of;Vietnam;Ukraine;Thailand;Philippines;New Zealand;Korea, Republic of | ; | Hee Jin Cheong;Yoonyeong Lee | | ;yoonyeong@sk.com | ;+82 2-2008-2337 | Korea University Guro Hospital; |
<br> Inclusion Criteria:
<br>
<br> - Participant must be 18 years of age and older, at the time of signing the informed
<br> consent;
<br>
<br> - Participants who are healthy or medically stable as determined by medical evaluation
<br> including medical history, physical examination, clinical laboratory tests, and
<br> medical judgement of the investigator;
<br>
<br> - Participants who are able to attend all scheduled visits and comply with all study
<br> procedures;
<br>
<br> - Female participants of childbearing potential must agree to be heterosexually
<br> inactive, or agree to consistently use at least one acceptable method of contraception
<br> from at least 4 weeks prior to the 1st study vaccination to 12 weeks after the last
<br> study vaccination;
<br>
<br> - Female participants with a negative urine or serum pregnancy test at screening;
<br>
<br> - Capable of giving signed informed consent which includes compliance with the
<br> requirements and restrictions listed in the informed consent form (ICF) and in
<br> protocol;
<br>
<br> Exclusion Criteria:
<br>
<br> - Any clinically significant respiratory symptoms (e.g., cough, sore throat), febrile
<br> illness (tympanic temperature >38°C), or acute illness within 72 hours prior to the
<br> 1st study vaccination. A prospective participant should not be included until 72 hours
<br> after the condition has resolved;
<br>
<br> - (Only for Cohort 1) Prior SARS-CoV-2 infection or vaccination confirmed by a positive
<br> result of qualitative test for SARS-CoV-2 antibody using a rapid antibody kit at
<br> screening;
<br>
<br> - History of virologically-confirmed SARS or MERS disease, or SARS / MERS vaccination;
<br>
<br> - History of congenital, hereditary, acquired immunodeficiency, or autoimmune disease;
<br>
<br> - History of bleeding disorder or thrombocytopenia which is contraindicating
<br> intramuscular vaccination;
<br>
<br> - History of hypersensitivity and severe allergic reaction (e.g., anaphylaxis,
<br> Guillain-Barre syndrome) to any vaccines or components of the study vaccine;
<br>
<br> - History of malignancy within 1 year prior to the 1st study vaccination (with the
<br> exception of malignancy with minimal risk of recurrence at the discretion of the
<br> investigator);
<br>
<br> - Significant unstable chronic or acute illness that, in the opinion of the
<br> investigator, might pose a health risk to the participant if enrolled, or could
<br> interfere with the protocol-specified activities, or interpretation of study results;
<br>
<br> - Any other conditions which, in the opinion of the investigator, might interfere with
<br> the evaluation of the study objectives (e.g., alcohol or drug abuse, neurologic or
<br> psychiatric conditions);
<br>
<br> - Female participants who are pregnant or breastfeeding;
<br>
<br> - Receipt of any vaccine within 4 weeks prior to the 1st study vaccination or planned
<br> receipt of any vaccine from enrollment through 28 days after the last study
<br> vaccination (Visit 7), except for influenza vaccination, which may be received at
<br> least 2 weeks prior to the 1st study vaccination. This exception includes monovalent
<br> pandemic influenza vaccines and multivalent influenza vaccines;
<br>
<br> - Receipt of immunoglobulins and/or any blood or blood products within 12 weeks prior to
<br> the 1st study vaccination;
<br>
<br> - Receipt of any medications or vaccinations intended to prevent COVID-19;
<br>
<br> - Chronic use (more than 2 consecutive weeks) of immunosuppressive therapy, such as
<br> anticancer chemotherapy or radiation therapy; or long-term systemic corticosteroid
<br> therapy (=10mg prednisone/day or equivalent for more than 2 consecutive weeks) within
<br> 12 weeks prior to the 1st vaccination. The use of topical and nasal glucocorticoids
<br> will be permitted;
<br>
<br> - Participation in another clinical study involving study intervention within 4 weeks
<br> prior to the 1st study vaccination, or concurrent, planned participation in another
<br> clinical study with study intervention during the study period.
<br>
<br> - Participants who are subjected to any global or local restrictions in place for use of
<br> ChAdOx1-S (e.g. age, gender, or other specific population groups)
<br>
<br> - Investigators, or study staff who are directly involved in the conduct of this study
<br> or supervised by the investigator, and their respective family members.
<br> | | Covid19 | Biological: GBP510 adjuvanted with AS03 (Receptor-Binding Domain(RBD) 25ug/dose);Biological: ChAdOx1-S not less than 2.5 × 10^8 infectious units | Percentage of participants with = 4-fold rise in wild-type virus neutralizing antibody titer from baseline;Geometric Mean Titer(GMT) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays→Geometric Mean Titer(GMT) of neutralizing antibody to the SARS-CoV-2 measured by wild-type virus neutralization assays;Percentage of participants with = 4-fold rise in wild-type virus neutralizing antibody titer from baseline | | | | Yes | False | | |
| NCT05012943 | 26 October 2021 | The ARCT-154 Self-Amplifying RNA Vaccine Efficacy Study (ARCT-154-01) | A Randomized, Observer-Blind, Placebo-Controlled Study to Assess the Safety, Immunogenicity and Efficacy of the SARS-CoV-2 Self- Amplifying RNA Vaccine ARCT-154 in Adults | ARCT-154-01 | Vinbiocare Biotechnology Joint Stock Company | 13/08/2021 | 20210813 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05012943 | Recruiting | No | 18 Years | 100 Years | All | August 15, 2021 | 21000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | Vietnam | | Van T Nguyen, PhD | | v.vannt73@vinbiocare.com | +84-903457399 | |
<br> Inclusion Criteria:
<br>
<br> Individuals who:
<br>
<br> 1. are able to provide consent
<br>
<br> 2. agree to comply with all study visits and procedures
<br>
<br> 3. are sexually active and willing to adhere to contraceptive requirements
<br>
<br> 4. are male or female =18 years of age (or, for Phase 1, 18 to < 60 years of age)
<br>
<br> 5. are at higher risk of developing COVID-19 based on where they work or live
<br>
<br> Exclusion Criteria:
<br>
<br> Individuals who:
<br>
<br> 1. Significant infection or other acute illness, including body temperature >100.4°F
<br> (>38.0°C) on the day prior to or Day 1. Participants meeting this criterion may be
<br> rescheduled within the relevant window periods. Afebrile participants with minor
<br> illnesses can be enrolled at the discretion of the investigator.
<br>
<br> 2. Pregnant or breastfeeding.
<br>
<br> 3. Known history of COVID-19 (asymptomatic SARS-CoV-2 infection and/or nucleocapsid
<br> positive test is not exclusionary).
<br>
<br> 4. Close contact with a person known to be SARS-CoV-2 positive or with a clinical
<br> diagnosis of COVID-19 within 7 days prior to enrollment. Participants meeting this
<br> criterion who remain asymptomatic for 7 days may be rescheduled for enrollment within
<br> the relevant windows.
<br>
<br> 5. Known history of anaphylaxis, urticaria, or other significant adverse reaction to the
<br> vaccine or its excipients.
<br>
<br> 6. Known history of anaphylaxis to other vaccines.
<br>
<br> 7. Bleeding disorder considered a contraindication to intramuscular (IM) injection or
<br> phlebotomy.
<br>
<br> 8. Immunosuppressive or immunodeficient state, asplenia, recurrent severe infections, or
<br> known to be HIV positive.
<br>
<br> 9. An underlying clinically significant acute or chronic medical condition or physical
<br> examination findings for which, in the opinion of the investigator, participation
<br> would not be in the best interest of the participant (eg, compromise the well-being)
<br> or that could prevent, limit, or confound the protocol-specified assessments.
<br>
<br> Prior/Concomitant Therapy
<br>
<br> 10. Has previously received investigational or approved MERS-CoV, SARS-CoV, SARS-CoV-2
<br> vaccines or who have plans to receive off-study COVID-19 vaccines.
<br>
<br> 11. Has received a live replicating vaccine within 28 days prior to each study vaccination
<br> or a licensed inactivated or non-replicating vaccine within 14 days prior to first
<br> study vaccination.
<br>
<br> 12. Has received treatment with immunosuppressive therapy, including cytotoxic agents or
<br> systemic corticosteroids, eg, for cancer or an autoimmune disease, within 6 months
<br> prior to Screening, or planned receipt throughout the study. If systemic
<br> corticosteroids have been administered short term (<14 days) for treatment of an acute
<br> illness, participants should not be enrolled into the study until corticosteroid
<br> therapy has been discontinued for at least 28 days prior to first study vaccine
<br> administration. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or
<br> eyes) corticosteroids are permitted.
<br>
<br> 13. Has received systemic immunoglobulins or blood products within 3 months prior to first
<br> study vaccine administration or plans to receive such products during the study.
<br>
<br> Other Exclusions
<br>
<br> 14. Demonstrated inability to comply with the study procedures.
<br>
<br> 15. Investigator site staff members, employees of the Sponsor or the CRO directly involved
<br> in the conduct of the study, or site staff members otherwise supervised by the
<br> investigator, or immediate family members of any of the previously mentioned
<br> individuals.
<br>
<br> 16. Other restrictions apply to Phase 1 participants to ensure they are healthy.
<br> | | COVID-19 Vaccines | Biological: ARCT-154 Self-Amplifying RNA SARS-CoV-2 Vaccine;Other: Placebo (normal saline) | Number of participants with a first occurrence of COVID-19;Neutralizing antibody (NAb) responses (for Phase 1/2/3a);Percentage of participants reporting serious adverse events, medically attended adverse events and adverse events leading to discontinuation;Percentage of participants reporting adverse events;Percentage of participants reporting systemic events;Percentage of participants reporting local reactions | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05077319 | 26 October 2021 | Characteristics and Outcome of Patients With COVID-19 in ICUs in South Tyrol | Characteristics and Outcome of Patients With COVID-19 Associated Respiratory Failure Treated in South Tyrol, Italy | | Institute of Mountain Emergency Medicine | 04/10/2021 | 20211004 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05077319 | Not recruiting | No | 18 Years | N/A | All | March 5, 2020 | 550 | Observational | | | Italy | | Simon Rauch, MD, PhD | | | | Institute of Mountain Emergency Medicine |
<br> Inclusion Criteria:
<br>
<br> - All patients admitted to the intensive care units in South Tyrol due to COVID-19
<br> associated respiratory failure
<br>
<br> Exclusion Criteria:
<br>
<br> - SARS-CoV-2 patients admitted to the intensive care units in South Tyrol for other
<br> pathologies (i.e., not respiratory failure)
<br> | | COVID-19;COVID-19 Acute Respiratory Distress Syndrome | | Mortality | | | | No | False | | |
| → | NCT05077332 | 26 October 2021 | LEAP-CT for Treatment of COVID-19 Patients (Master Protocol) | Leidos-Enabled Adaptive Protocol for Clinical Trials (LEAP-CT) to Evaluate the Safety and Efficacy of Drug Combinations in COVID-19 Patients | | Leidos Life Sciences | 07/10/2021 | 20211007 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05077332 | Not recruiting | No | 18 Years | N/A | All | October 2021 | 2000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2 | | ; | Brian A Roberts, MS, PMP;Brian A Roberts, MS, PMP | | ;brian.a.roberts@leidos.com | ;240-529-0455 | Leidos, Inc.; |
<br> - For eligibility criteria specific to the protocol, see:
<br>
<br> - Addendum #1 (LDOS-21-001-01) or
<br>
<br> - Addendum #2 (LDOS-21-001-02)
<br> | | 2019 Novel Coronavirus Disease;2019 Novel Coronavirus Infection;2019-nCoV Disease;2019-nCoV Infection;COVID-19 Pandemic;COVID-19 Virus Disease;COVID-19 Virus Infection;Covid19;Coronavirus Disease 2019;SARS-CoV-2 Infection;SARS-CoV-2 Acute Respiratory Disease;COVID-19 | Drug: Famotidine;Drug: Celecoxib;Other: Placebo | (LDOS-21-001-01) Time-to-event to achieve WHO level =3;(LDOS-21-001-01) Death rate;(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to increased COVID-19 symptom severity;(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality)→(LDOS-21-001-01) Time-to-event to achieve WHO level =3;(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to death (all-cause mortality);(LDOS-21-001-02) Number of patients with at least one COVID-19-related medically attended contact due to increased COVID-19 symptom severity;(LDOS-21-001-01) Death rate | | | | Yes | False | | |
| NCT05077813 | 26 October 2021 | Utilizing the Crosstalk Among Chicoric Acid, 13-Cis Retinoic Acid(Aerosolized), Minocycline and Vitamin D as a Potent Quadrate Therapy for Treating Patients With Multidrug-resistant TB and Patient With Both Multidrug-resistant TB and COVID-19 | Utilizing the Crosstalk Among Chicoric Acid, 13-Cis Retinoic Acid(Aerosolized), Minocycline and Vitamin D as a Potent Quadrate Therapy for Treating Patients With Multidrug-resistant TB and Patient With Both Multidrug-resistant TB and COVID-19 | | Kafrelsheikh University | 10/10/2021 | 20211010 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05077813 | Not recruiting | No | 18 Years | 65 Years | All | December 2021 | 250 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). | Phase 2 | Egypt;Saudi Arabia;Egypt;Saudi Arabia | ; ; | Dr Mahmoud R Elkazzaz, M.Sc of Biochemistry;Amr K Ahmed;Dr Mahmoud R Elkazzaz, M.Sc of Biochemistry | | ;;mahmoudramadan2051@yahoo.com | ;;00201090302015 | Faculty of Science , Damietta University;Ministry of Health; |
<br> Inclusion Criteria:
<br>
<br> - Age above 18 up to 65 years
<br>
<br> - Microbiologically or histologically confirmed active tuberculosis as well as confirmed
<br> positive with COVID-19
<br>
<br> - Clinically confirmed latent tuberculosis
<br>
<br> - Drug resistant MTb
<br>
<br> - Negative pregnancy test for 18-40 year-old females
<br>
<br> - Able to sign consent
<br>
<br> Exclusion Criteria:
<br>
<br> - HIV positive
<br>
<br> - Known intolerance of vitamin D
<br>
<br> - Sarcoidosis
<br>
<br> - Hyperparathyroidism or nephrolithiasis
<br>
<br> - Taking vitamin D or A supplementation in the two months preceding enrolment
<br>
<br> - Baseline serum corrected calcium >2.65 mmol/L
<br>
<br> - Current haemodialysis
<br>
<br> - Children, pregnant or breastfeeding individuals
<br>
<br> - Concomitant benzothiadiazine derivative, cardiac glycoside, carbamazepine,
<br> phenobarbital, phenytoin, primidone or long-term immunosuppressant therap
<br>
<br> - Extra-pulmonary or smear negative tuberculosis
<br>
<br> - Patients receiving steroids, cytotoxic drugs, post transplant or metastatic
<br> malignancy, or not expected to survive for the duration of ATT
<br>
<br> - Pregnant or lactating women
<br>
<br> - Active diarrhoea, indicating possible fat-soluble vitamin malabsorption.
<br>
<br> - Baseline Hypercalcemia >10.5 mg/dl
<br>
<br> - Concurrent use of cyclosporin, cisplatin, amfotericin B, cephalosporins, polymyxins
<br> and vancomycin.
<br>
<br> - History of adverse events on previous Minocycline or other tetracycline use (by
<br> spontaneous reporting nor by active questioning).
<br>
<br> - Depressive disorder
<br>
<br> - Body mass index less than 18 points or higher than 25 points
<br>
<br> - Contraindications for hormonal contraception or intrauterine device.
<br>
<br> - Autoimmune diseases A history of organ, bone marrow or hematopoietic stem cell
<br> transplantation
<br>
<br> - Patients receiving anti-hcv treatment
<br>
<br> - Permanent blindness in one eye
<br>
<br> - History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of
<br> retinal detachment or eye surgery
<br> | | Tuberculosis | Combination Product: 13 cis retinoic acid, Minocycline, Chicroic Acid and Vitamin D for (MDR-TB);Combination Product: 9 cis retinoic acid, Minocycline, Chicroic Acid and Vitamin D for (MDR-TB);Combination Product: All trans retinoic acid , Minocycline,Chicroic Acid and Vitamin D for (MDR-TB);Combination Product: All trans retinoic acid, Minocycline, Chicroic Acid and Vitamin D For (COVID-19 and MDR-TB);Combination Product: 13 cis retinoic acid, Minocycline, Chicroic Acid and Vitamin D For (COVID-19 and MDR-TB);Other: The standard therapy | Time to first negative SARS-CoV-2 PCR in NP swap and Mycobacterium tuberculosis sputum culture | | | | Yes | False | | |
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| ISRCTN19674644 | 26 October 2021 | BRIGhTMIND: brain imaging guided transcranial magnetic stimulation in depression | Randomised double-blind controlled trial of connectivity guided theta burst transcranial magnetic stimulation versus repetitive transcranial magnetic stimulation for treatment resistant moderate to severe depression evaluation of efficacy, cost effectiveness and mechanism of action | | Nottinghamshire Healthcare NHS Foundation Trust | 02/10/2018 | 20181002 | ISRCTN | https://www.isrctn.com/ISRCTN19674644 | Recruiting | No | | | Both | 15/10/2018 | 368 | Interventional | Randomised; Interventional; Design type: Treatment, Device, Imaging, Psychological & Behavioural, Complex Intervention (Treatment) | Not Specified | England;United Kingdom | | | | | | | Inclusion criteria: <br> Current inclusion criteria as of 13/10/2021:<br> 1. Adults >18 years<br> 2. Diagnosis of MDD (defined according to DSM-5) that is treatment resistant (defined as scoring 2 or more (42) on the Massachusetts General Hospital Treatment Resistant Depression staging score (51) See appendix on more detailed scoring of treatment resistance<br> 3. HDRS-17 score of 16 or more (moderate to severe depression) (52)<br> 4. Capacity to provide informed consent before any trial-related activities<br><br> Previous inclusion criteria:<br> 1. Adults >18 years<br> 2. Diagnosis of MDD (defined according to DSM-5) that is treatment resistant (defined as scoring 2 or more on the Massachusetts General Hospital Treatment Resistant Depression staging score)<br> 3. Capacity to provide informed consent before any trial-related activities<br> | Exclusion criteria: <br> Current exclusion criteria as of 02/07/2019:<br> History of bipolar disorder (due to risk of mania) or depression secondary to other mental disorder<br> 2. Neurological conditions e.g. brain neoplasm, cerebrovascular events, epilepsy, neurodegenerative disorders, and prior brain surgery<br> 3. Standard contraindications to MRI i.e. irremovable metal objects in and around body e.g. cardiac pacemaker, implanted medication pump and pregnancy (any doubt resolved by pregnancy test, women of childbearing age taking precautions against pregnancy) This will include other potential complicated factors such as red tattoo’s which consist of iron on the head, neck and back and claustrophobia (we offer mock scanner testing and training in some sites)<br> 4. Major unstable medical illness requiring further investigation or treatment.<br> 5. Change in prescribed medication 2 weeks before baseline assessment.<br> 6. Prescription of lamotrigine, gabapentin, pregabalin in the 2 weeks prior to baseline assessment.<br> 7. Daily prescription of benzodiazepine above 5 mg diazepam equivalents, zopiclone above 7.5 mg, zolpidem above 10 mg or zaleplon above 10 mg. These<br> drugs should not be used intermittently in the 2 weeks before baseline assessment.<br> 8. Current substance abuse or dependence defined by DSM-5 criteria)<br> 9. Prior TMS treatment.<br> 10. At risk of suicidality.<br> 11. Potential complicated factors relating to the TMS treatment i.e. hairstyles which would impair magnetic transmission and piercings. (Participants would only be excluded if they chose to not make the changes required to ensure effective treatment.)<br> 12. Involved with any other clinical trial at the time of consent or 6 months prior.<br> 13. Unable to read or understand English.<br><br> Previous exclusion criteria:<br> 1. History of bipolar disorder (due to risk of mania) or depression secondary to other mental disorder<br> 2. Neurological conditions e.g. brain neoplasm, cerebrovascular events, epilepsy, neurodegenerative disorders, and prior brain surgery<br> 3. Standard contradictions to MRI i.e. irremovable metal objects in and around body e.g. cardiac pacemaker, implanted medication pump and pregnancy (any doubt resolved by pregnancy test, women of childbearing age taking precautions against pregnancy). This will include other potential complicated factors such as red tattoos which consist of iron on the head, neck and back and claustrophobia (we offer mock scanner testing and training in some sites)<br> 4. Major unstable medical illness requiring further investigation or treatment<br> 5. Change in prescribed medication in the 2 weeks preceding the start of TMS trial or prescription of lamotrigine, pregabalin, gabapentin or benzodiazepines that act on brain glutamate or GABA (only occasional use of other hypnotic drugs zopiclone, zolpidem, zoleplon and promethazine will be allowed)<br> 6. Current substance abuse or dependence (defined by DSM-5 criteria)<br> 7. Prior TMS treatment<br> 8. At risk of suicidality<br> 9. Potential complicated factors relating to the TMS treatment i.e hairstyles which would impair magnetic transmission and piercings (participants would only be | Depression <br>Mental and Behavioural Disorders | <br> Current interventions as of 13/10/2021:<br> The study is a multicentre parallel-group, double-blinded randomised controlled trial of the efficacy of Connectivity Guided Intermittent theta-burst stimulation (cgiTBS) versus no connectivity guided standard Repetitive Transcranial Magnetic Stimulation (rTMS); in patients over the age of 18 who have a diagnosis of moderate to severe major depressive disorder and have treatment-resistant depression. The study will look to recruit 266 patients (133 in each treatment group) from 4/5 sites. Initially, recruitment sites were Nottingham, London, Newcastle and Northampton until 1/9/20; after 1/9/20 with restart following a break in recruitment with the COVID-19 pandemic the following sites reopened to recruitment; Nottingham, London, Newcastle and Oldham with a revision to recruitment rates and use of remote methods when possible. Recruitment will be from both primary and secondary care settings by a letter of invitation requesting a reply slip to be returned to the research team and will also recruit from patient self-referrals..<br><br> Eligibility screening<br> Interested patients will receive an eligibility screening telephone call, and if eligible they will be invited to attend a remote baseline assessment.<br><br> Baseline assessment<br> With the restart of the study following the COVID-19 pandemic, baseline assessments can be done either face to face or remotely (digital or telephone).<br> The baseline assessment, which will take a maximum of 2 hours, will be to obtain consent and answer any questions, then to assess their clinical symptoms by the completion of researcher interviews and self-rated questionnaires which will further establish th | <br> Current primary outcome measure as of 13/10/2021:<br> The efficacy of cgiTBS compared with standard rTMS measured using the Hamilton Depression Rating Scale (HDRS-17) at baseline, 8, 16 and 26 weeks post randomisation date<br><br> Previous primary outcome measure:<br> The efficacy of cgiTBS at 16 weeks (primary clinical outcome, 50% drop in HDRS-17 score from baseline to 16 weeks) and 26 weeks compared with standard rTMS; in people with TRD ; Timepoint(s): 16 and 26 weeks post randomisation<br> | | 31/01/2023 | | Yes | False | | |
| → | EUCTR2020-002458-25-IT | 26 October 2021 | Clinical study for the treatment with Interferon-ß-1a (IFNß-1a) of COVID-19 patients: randomized, controlled, open label | Randomized, controlled, open label, phase 2 clinical trial of Interferon-ß-1a (IFNß-1a) in COVID-19 patients. - Clinical study for the treatment with Interferon-ß-1a (IFNß-1a) of COVID-19 patients | | OSPEDALE SAN RAFFAELE | 10/08/2020 | 20200810 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002458-25 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 23/06/2020 | 126 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Standard of Care<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Italy | Unità di Medicina Generale, Diabete | | Via Olgettina, 60 | bosi.emanuele@hsr.it | +390226432827 | IRCCS Ospedale San Raffaele | Inclusion criteria: <br>a. Informed consent signed<br>b. Patients hospitalized with confirmed swab RT-PCR detection of SARS-CoV-2<br>c. X-ray and/or TC diagnosed pneumonia<br>d. Age >=18 years<br>e. Clinical status defined as 3, 4 or 5 on the 7-point ordinal scale<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 63<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 63<br> | Exclusion criteria: <br>a. Known allergy or hypersensitivity to IFNß-1a or IFNß-1b<br>b. Presence of severe concomitant illnesses/medical conditions that in the physician opinion do not allow participation to the stud<br>c. Pregnant or lactating females<br>d. History of major depression disorder or suicidal attempt or suicidal ideation<br>e. Spontaneous blood ALT/AST levels > 5 times the upper limit of normal<br>f. Clinical status defined as 1, 2, or 6 on the 7-point ordinal scale<br> | SARS-Cov-2 infection (COVID-19) <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: REBIF - 44 MCG(12 MILIONI UI) -SOLUZ INIETTABILE- USO SOTTOCUTANEO-PENNA PRERIEMPITA 0.5 ML (24 MILIONI UI/ML) 1 PENNA PRERIEMPITA<br>Product Name: Interferone-ß-1a<br>Product Code: [IFNß-1a]<br>Pharmaceutical Form: Solution for injection<br>INN or Proposed INN: INTERFERONE BETA 1A<br>Current Sponsor code: IFNß-1a<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 44-<br><br> | Primary end point(s): Time to negative conversion of SARS-CoV-2 nasopharyngeal swab. Viral load will be measured by RT-PCR.;Timepoint(s) of evaluation of this end point: Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29;Secondary Objective: I. To determine the efficacy of IFNß-1a to improve the clinical status and respiratory functions in hospitalized COVID-19 patients.<br>II. To determine the efficacy of IFNß-1a to reduce mortality in COVID-19 patients<br>III. To determine the efficacy of IFNß-1a to improve the chest CT scan picture in hospitalized COVID-19 patients.<br>IV. To determine the efficacy of IFNß-1a to reduce the time of hospitalization in hospitalized COVID-19 patients.<br>V. To determine the efficacy of IFNß-1a to reduce the viral load of SARS-CoV-2 measured on plasma<br>VI. To determine the safety of the use of IFNß-1a in hospitalized COVID-19 patients.;Main Objective: To determine the efficacy of IFNß-1a as time to negative conversion of SARS-Cov-2 nasopharyngeal swab in hospitalized COVID-19 patients→Main Objective: To determine the efficacy of IFNß-1a as time to negative conversion of SARS-Cov-2 nasopharyngeal swab in hospitalized COVID-19 patients;Secondary Objective: I. To determine the efficacy of IFNß-1a to improve the clinical status and respiratory functions in hospitalized COVID-19 patients.<br>II. To determine the efficacy of IFNß-1a to reduce mortality in COVID-19 patients<br>III. To determine the efficacy of IFNß-1a to improve the chest CT scan picture in hospitalized COVID-19 patients.<br>IV. To determine the efficacy of IFNß-1a to reduce the time of hospitalization in hospitalized COVID-19 patients.<br>V. To determine the efficacy of IFNß-1a to reduce the viral load of SARS-CoV-2 measured on plasma<br>VI. To determine the safety of the use of IFNß-1a in hospitalized COVID-19 patients.;Timepoint(s) of evaluation of this end point: Baseline, days 3, 5, 7, 9, 11, 13, 15, 21, 29;Primary end point(s): Time to negative conversion of SARS-CoV-2 nasopharyngeal swab. Viral load will be measured by RT-PCR. | | | | No | False | | |
| EUCTR2020-004408-32-GR | 26 October 2021 | Clinical trial of the investigational drug AMY-101 for the treatment of patients with severe COVID-19. | ITHACA: A phase 2, randomized, single-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of the complement C3 inhibitor, AMY-101, in COVID-19 patients with acute respiratory distress syndrome (ARDS). - ITHACA | | Amyndas Pharmaceuticals S.A. | 01/10/2020 | 20201001 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-004408-32 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 23/10/2020 | 62 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: yes<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Greece | Panagiotis Skendros, MD, PhD | | University Hospital of Alexandroupolis, Dragana Campus | pskendro@med.duth.gr | +302551351091 | University Hospital of Alexandroupolis | Inclusion criteria: <br>1.Adult (age = 18), of any gender.<br>2.Diagnosed with Acute Respiratory Distress Syndrome due to SARS-CoV-2 infection (severe COVID-19), according to the following criteria:<br>a)Demonstration of SARS-CoV-2 RNAemia in nasopharyngeal swab or bronchio-alveolar lavage (BAL) (note: the test that will be used for SARS-CoV-2 RNAemia is certified with the CE mark and will be used within the scope of its intended purpose)<br>b)A ratio of the partial pressure of oxygen (PaO2) to the fraction of inspired oxygen (FiO2), PaO2/FIO2, =200 mmHg <br>c)Pulmonary infiltrates suggestive of SARS-COV-2-related ARDS: e.g., bilateral infiltrates at chest X-ray or B-lines at lung US scan<br>3.Dated and signed informed consent from patient or legal represantatives.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 20<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 42<br> | Exclusion criteria: <br>1.Intubated patients<br>2.Demonstrated or suspected uncontrolled systemic severe infection, such as sepsis (e.g.: positive blood culture, or increasing procalcitonin levels =0.5 µg/L) <br>3.Demonstrated local extrapulmonary abscess<br>4.ARDS due to cardiac failure or fluid overload<br>5.Concomitant treatment with immunomodulatory /immunosuppressive drugs, which have potential activity against the disease<br>6.Concomitant treatment with convalescent plasma<br>7.Concominant treatment with non-specific intravenous immunoglobulins (IVIG) or SARS-CoV-2 specific immunoglobulins<br>8.Multi Organ Failure (MOF)<br>9.Severe renal failure (CKD, by defition glomerular filtration rate <30 ml/min)<br>10.Neisseria meningitidis infection that is not resolved<br>11.Current treatment with a complement inhibitor<br>12.Intravenous immunoglobulin (IVIg) within 3 weeks prior to Screening<br>13.Ongoing participation in another interventional treatment study or participation in another interventional treatment study within 30 days before initiation of the study treatment (Day 1 in this study) or within 5 half-lives of that investigational product, whichever is greater.<br>14.Chemotherapy for less than 3 months<br>15.Pregnancy<br>16.Age <18<br><br> | Severe COVID-19, with Acute Respiratory Distress Syndrome (ARDS). <br>MedDRA version: 23.0
Level: LLT
Classification code 10084270
Term: SARS-CoV-2 acute respiratory disease
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: AMY-101 acetate (also known as Cp40 and Cp-14 in the scientific literature/ documentation)<br>Pharmaceutical Form: Powder for solution for infusion<br>INN or Proposed INN: Not available yet<br>CAS Number: 1427001-89-5<br>Current Sponsor code: AMY-101 acetate<br>Other descriptive name: S3,S13-CYCLO(D-TYROLSYL-L-ISOLEUCYL-L-CYSTEINYL-L-VALYL-1-METHYL-L-TRYPTOPHYL-L-GLUTAMINYL-L-ASPARTYL-L-TRYPTOPHYL-N-METHYL-L-GLYCYL-L-ALANYL-L-HISTIDYL-L-ARGINYL-L-CYSTEINYL-N-METHYL-L-ISOLEUCINAMIDE) ACETATE<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 50-<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous drip use (Noncurrent)<br><br> | Timepoint(s) of evaluation of this end point: Day 14;Primary end point(s): The primary endpoint of the study is the proportion of patients who are alive, without evidence of ARDS (as denoted by PaO2/FIO2 >300 mm Hg), who do not require any oxygen support (in room air), at day 14.;Secondary Objective: The secondary objectives are to assess the safety, further measures of clinical efficacy and PK/PD of AMY-101 in patients.;Main Objective: The primary objective is to assess the impact of AMY-101 on the survival without ARDS and without oxygen requirement at day 14 in patients with severe COVID-19. | | | | Yes | False | | |
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| EUCTR2020-002982-33-SE | 26 October 2021 | A study to to evaluate the efficacy, safety and tolerability of PDNO (nitrosooxypropanol) infusion in COVID-19 patients with high blood pressure in lung arteries. | An open-label, multicenter study to evaluate the efficacy, safety and tolerability of PDNO (nitrosooxypropanol) infusion in COVID-19 patients with acute pulmonary hypertension | | Attgeno AB | 21/12/2020 | 20201221 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-002982-33 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 02/03/2021 | 16 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Sweden | CRM | | Dag Hammarskjölds väg | janet.hakansson@ctc-ab.se | 0046(0)70330 18 51 | CTC Clinical Trial Consultants AB | Inclusion criteria: <br>1. Ability to understand and willing to sign an informed consent form after information at the pre-screening visit.<br>2. Male and female patients, age at least 18 years on the date of the informed consent at the time of the pre-screening visit. <br>3. Diagnosed with COVID-19 at admission to the ICU.<br>4. Diagnosed with echocardiographic signs of pulmonary artery systolic pressure (PASP) >40 mmHg, as estimated by doppler defined echocardiography using a modified Bernoulli equation: PASP ˜ 4 (tricuspid regurgitant jet velocity)2 + CVP. After insertion of the PAC, a MPAP =20 mmHg will allow continued participation and start of PDNO infusion. If MPAP is <20 mm Hg, the patient is considered a screen failure and may be replaced.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 10<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 6<br> | Exclusion criteria: <br>1. History of chronic pulmonary hypertension, as judged by the Investigator at screening<br>2. Known New York Heart Association (NYHA) Functional Class III or IV symptoms (pre-Covid 19) at screening.<br>3. Left heart failure with ejection fraction (EF) < 35 % at screening<br>4. Acute coronary syndrome (non ST elevation myocardial infarction [non-STEMI], ST elevation myocardial infarction [STEMI], unstable angina pectoris [AP]), myocardial infarction, stroke, transient ischemic attack (TIA), AV block III within 3 months prior to informed consent or QTcF >450ms at the time of screening.<br>5. Body Mass Index (BMI) > 45 kg/m2 at screening<br>6. Estimated glomerular filtration rate (eGFR) < 30 mL/min at screening<br>7. Methaemoglobin >3% at screening<br>8. PCO2 > 7 at screening<br>9. Indication of liver disease, defined by serum levels of either ALT, AST or alkaline phosphatase above 3 x upper limit of normal (ULN) at screening<br>10. Haemoglobin <80 g/dL at screening<br>11. Thrombocytopenia (platelet count <80000/mm3) at screening <br>12. Prothrombin time International ratio (INR) > 1.4 at screening <br>13. Pregnancy, or a positive pregnancy test at screening (for fertile women only)<br>14. Ongoing daily treatment the last 3 days with non-steroidal anti-inflammatory drugs (NSAIDs, excluding low dose, i.e. 75 mg, acetylsalicylic acid), new oral anticoagulants (NOACs), warfarin, heparin, clopidogrel (last 5 days). Low molecular weight heparin (LMWH) is not an exclusion criterion.<br>15. Known active malignancy within the past 3 years except for localized prostate cancer, cervical carcinoma in situ, breast cancer in situ, or nonmelanoma skin cancer that has been definitively treated.<br>16. History of allergy/hypersensitivity to PD or ongoing allergy/hypersensitivity or history of hypersensitivity to drugs with a similar chemical structure or class to PDNO.<br>17. History of any other clinically significant disease or disorder which, in the opinion of the investigator, may either put the patient at increased risk because of participation in the study, or influence the results or the ability to participate in the study.<br>18. Participation in any interventional clinical study or has been treated with any investigational research products within 30 days or 5 half-lives, whichever is longer, prior to the initiation of screening.<br><br> | Acute pulmonary hypertension during COVID-19 infection <br>MedDRA version: 20.0
Level: HLT
Classification code 10037401
Term: Pulmonary hypertensions
System Organ Class: 100000004855
;Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14] | <br>Product Code: PDNO<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: PDNO<br>CAS Number: 950478-72-5<br>Current Sponsor code: PDNO<br>Other descriptive name: 1-(nitrosooxy)propan-2-ol<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: range<br>Concentration number: 10.5-63.1<br>INN or Proposed INN: PDNO<br>CAS Number: 950478-73-6<br>Current Sponsor code: PDNO<br>Other descriptive name: 2-(nitrosooxy)propan-1-ol<br>Concentration unit: mg/g milligram(s)/gram<br>Concentration type: range<br>Concentration number: 10.5-63.1<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br> | Timepoint(s) of evaluation of this end point: At target dose after up-titration and 10 minutes after steady state (according to study flow chart);Primary end point(s): Change in MPAP and calculated PVR measured with pulmonary arterial catheterization, at target dose after up-titration and 10 minutes after steady state. ;Secondary Objective: - To evaluate the safety and tolerability of PDNO in patients with COVID-19. <br>- To evaluate general clinical outcome. <br>- To decide the time to non-SARS-CoV-2 infection.<br>- To evaluate the change in troponin I/T and BNP/NT-proBNP after 3 hours of PDNO dosing in patients with Covid-19 and PH.<br>- To evaluate the efficacy of PDNO on the pulmonary resistance.<br>Exploratory Objectives:<br>- To explore potential biomarkers.<br>- To assess presence of SARS-CoV-2 virus. <br>;Main Objective: To evaluate the efficacy of PDNO on pulmonary vascular resistance (PVR) and mean pulmonary artery pressure (MPAP), as measured with a pulmonary artery catheter (PAC), in patients with Covid 19 and pulmonary hypertension (PH). | | | | Yes | False | | |
| → | EUCTR2021-000316-31-ES | 26 October 2021 | Clinical trial to evaluate if treatment with calcifediol (vitamin D analog) reduces the number of hospital admissions in patients with COVID-19. | Multicenter, double-blind, randomized clinical trial to evaluate the efficacy of calcifediol soft capsules versus placebo in reducing hospital admissions in patients with a positive diagnostic test for SARS-CoV-2. - IMMUNOCOVIDIOL | | FAES FARMA S.A. | 30/07/2021 | 20210730 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000316-31 | Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | 15/07/2021 | 804 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Spain | Departamento de Operaciones | | C/ Azcona, 31 | ensayosclinicos@dynasolutions.com | +3491 456 11 05 | Dynamic Science S.L. | Inclusion criteria: <br>1. Age: over 18 years old<br>2. Patient with a suspected respiratory clinical picture of COVID-19, confirmed with a positive result either by PCR for SARS-CoV-2 of nasopharyngeal exudate with or without oropharyngeal exudate; and / or rapid antigen detection test (Antigen Rapid Diagnostic Test, Ag-RDT) of nasal or nasopharyngeal exudate.<br>The result of any of the diagnostic tests must be available within 72 hours of the onset of the clinical picture.<br>3. Present at least one of the following risk factors for the development of serious disease:<br>o Age = 60 years<br>o Body mass index (BMI) = 30 kg / cm2<br>o Chronic cardiovascular disease<br>o Chronic respiratory disease<br>o Chronic kidney disease<br>4. Voluntary signing of the Informed Consent (IC).<br>5. Only for women of reproductive age: availability to perform pregnancy tests; They should also agree to the use of highly effective birth control methods for the entire duration of the study, which include: combined hormonal contraceptives associated with ovulation inhibitors (oral, intravaginal or transdermal), hormonal contraceptives of progesterone associated with inhibitors of the ovulation (oral, injectable, or implantable), intrauterine device (IUD), intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomized partner (if such partner is the only sexual partner of the trial participant and has documentation of azoospermia) or sexual abstinence (defined as avoiding heterosexual sex for the entire risk period associated with trial treatment).<br>The investigator is responsible for determining whether the patient is using an appropriate birth control method for study participation.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 804<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 804<br> | Exclusion criteria: <br>1. Subjects who have been treated with calcifediol or cholecalciferol continuously and in doses greater than or equal to 0.266 mg / month or 800 IU / day, respectively, during the last 3 months.<br>2. Subjects who have taken or are required to take medications that can modify vitamin D levels within the last week before enrollment or during the study: phenobarbital, phenytoin, primidone, digoxin, rifampin, thiazide diuretics (hydrochlorothiazide), some antibiotics (penicillin, neomycin and chloramphenicol), antiretrovirals (tenofovir, adefovir), oral chronic corticosteroids (defined as a dose of prednisolone = 5 mg daily or equivalent) for more than 3 months, verapamil, paraffin, mineral oil laxatives, magnesium salts, actinomycin, and antifungal imidazoles. Subjects taking orlistat, cholestyramine, or colestipol who do not observe a time interval of at least 2 hours with respect to taking study medication.<br>3. History of hypersensitivity to any of the active ingredients or components of the investigational drug (IM).<br>4. Subjects who have taken calcium supplements within the last week before inclusion, or who require to take them during the study.<br>5. Uncorrected hypercalcemia (serum calcium> 10.5 mg / dL), known hypercalciuria, or history of nephrolithiasis.<br>6. Severe kidney disease, defined by CKD-EPI estimated glomerular filtration rate (GFR) <30 mL / min / 1.73m2<br>7. Diagnosis of liver failure, exacerbated congestive heart failure, malabsorption, primary hyperparathyroidism, hypoparathyroidism, prolonged immobilization, sarcoidosis, tuberculosis, or other granulomatous diseases.<br>8. Presence of serious illness that requires direct hospital admission or that due to its characteristics does not allow oral treatment.<br>9. Persons admitted to an institution by order of judicial authorities or other authorities.<br>10. People who cannot collaborate with the study procedures.<br>11. Patients with a current or previous history of neoplasia in the last five years.<br>12. History of previous hospitalization for COVID-19 or positive diagnostic test for SARS-CoV-2 before the current episode.<br>13. Women who are pregnant, nursing or planning a pregnancy.<br>14. Any other medical and / or therapeutic circumstance considered by the researcher that prevents adequate monitoring and / or adequate evolution of the response to the study treatment.<br>15. Patients who have received an investigational drug (including vaccines) or have used an investigational invasive medical device in the last 30 days prior to the start of the screening phase or are currently participating in another clinical trial.<br>16. Patients who have received the last dose of any of the approved SARS-CoV-2 vaccines less than 10 days prior to the start of the study; or who have not yet completed the vaccination.<br>NOTE: If the doctor knows or suspects that the patient does not have the capacity to understand the implications of her participation in the study, he should not allow her to enter without the signature of a legal representative of the same.<br> | SARS-CoV-2 coronavirus infection (COVID-19).;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Hidroferol® 0.266 mg soft capsules.<br>Product Name: Hidroferol<br>Pharmaceutical Form: Capsule, soft<br>Pharmaceutical form of the placebo: Capsule, soft<br>Route of administration of the placebo: Oral use<br><br> | Main Objective: To evaluate the efficacy of calcifediol in reducing hospital admissions in patients with a positive result for a diagnostic test for SARS-CoV-2 and at least one risk factor for the development of severe disease.;Secondary Objective: 1. To evaluate the safety of calcifediol in the treatment of patients with a positive result for SARS-CoV-2 and at least one risk factor.<br>2. Describe the frequency of admission to the intensive care unit (ICU) in patients with a positive result for SARS-CoV-2 and at least one risk factor, for each treatment group.<br>3. Describe the frequency of mortality in patients with a positive result for SARS-CoV-2 and at least one risk factor, for each treatment group.<br>4. Describe the morbidity and mortality in patients with a positive result for SARS-CoV-2 and at least one risk factor, for each treatment group.<br>5. Describe the evolution of the symptoms related to COVID-19, reported by the patients themselves.;Primary end point(s): Percentage of patients who, being initially in outpatient follow-up, require hospital admission as a consequence of SARS-CoV-2 infection.;Timepoint(s) of evaluation of this end point: During all the clinical trial period, from the screening to the end of study.→Timepoint(s) of evaluation of this end point: During all the clinical trial period, from the screening to the end of study.;Primary end point(s): Percentage of patients who, being initially in outpatient follow-up, require hospital admission as a consequence of SARS-CoV-2 infection.;Secondary Objective: 1. To evaluate the safety of calcifediol in the treatment of patients with a positive result for SARS-CoV-2 and at least one risk factor.<br>2. Describe the frequency of admission to the intensive care unit (ICU) in patients with a positive result for SARS-CoV-2 and at least one risk factor, for each treatment group.<br>3. Describe the frequency of mortality in patients with a positive result for SARS-CoV-2 and at least one risk factor, for each treatment group.<br>4. Describe the morbidity and mortality in patients with a positive result for SARS-CoV-2 and at least one risk factor, for each treatment group.<br>5. Describe the evolution of the symptoms related to COVID-19, reported by the patients themselves.;Main Objective: To evaluate the efficacy of calcifediol in reducing hospital admissions in patients with a positive result for a diagnostic test for SARS-CoV-2 and at least one risk factor for the development of severe disease. | 16/10/2021 | | https://www.clinicaltrialsregister.eu/ctr-search/trial/2021-000316-31/results | No | False | | Yes |
| EUCTR2021-004526-29-DE | 26 October 2021 | A multinational, phase 2, randomised, adaptive protocol to assess immune response and side effects of different COVID-19 vaccines given in older adults (75 years and older) already vaccinated against SARS-CoV-2 | A MULTINATIONAL, PHASE 2, RANDOMISED, ADAPTIVE PROTOCOL TO EVALUATE IMMUNOGENICITY AND REACTOGENICITY OF DIFFERENT COVID-19 VACCINES ADMINISTRATION IN OLDER ADULTS (=75) ALREADY VACCINATED AGAINST SARS-COV-2 (EU-COVAT-1 AGED)
- EU-COVAT-1 AGED | | University of Cologne | 06/09/2021 | 20210906 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-004526-29 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 19/10/2021 | 85 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 6<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany | Project Manager | | Herderstraße 52 | eucovat-1-aged@vaccelerate.eu | +4922147885523 | University of Cologne | Inclusion criteria: <br>• Elderly (=75 years old).<br>• Already fully vaccinated adults.<br>• Primary vaccination (1st and 2nd dose) using BNT162b2, mRNA-1273 or ChAdOx-1-S).<br>• No contra-indication against any of the vaccine products in the trial at time of enrolment.<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) no<br>F.1.2.1 Number of subjects for this age range <br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 600<br> | Exclusion criteria: <br>• Primary vaccination performed with different vaccine products as sole (e.g. COVID-19 Vaccine Janssen) or, 1st and 2nd vaccination doses (heterologous vaccination scheme).<br>• Any contraindication against any of the vaccines at time of enrolment including current SARS-CoV-2 infection or proven in the last 3 months.<br>• Immunocompromised status.<br><br><br> | Prevention of COVID-19 infection <br>MedDRA version: 23.1
Level: LLT
Classification code 10084464
Term: COVID-19 immunization
System Organ Class: 100000004865
<br>MedDRA version: 23.1
Level: LLT
Classification code 10084465
Term: COVID-19 vaccination
System Organ Class: 100000004865
<br>MedDRA version: 24.0
Level: LLT
Classification code 10085559
Term: Revaccination with different COVID-19 vaccine
System Organ Class: 100000004865
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084462
Term: SARS-CoV-2 vaccination
System Organ Class: 100000004865
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084463
Term: SARS-CoV-2 immunisation
System Organ Class: 100000004865
<br>MedDRA version: 23.0
Level: LLT
Classification code 10084466
Term: SARS-CoV-2 immunization
System Organ Class: 100000004865
;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Trade Name: Comirnaty <br>Pharmaceutical Form: Concentrate for dispersion for injection<br><br>Trade Name: Spikevax<br>Product Name: Spikevax<br>Pharmaceutical Form: Dispersion for injection<br><br> | Timepoint(s) of evaluation of this end point: 14 days after IMP administration;Primary end point(s): • Rate of 2-fold antibody titre increase following 3rd dose vaccination measured by quantitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wildtype virus 14 days after 3rd dose.;Secondary Objective: • To compare the humoral immune response against wild-type SARS-CoV-2 between treatment arms within each cohort following 3rd vaccination dose in elderly individuals (=75 years) already vaccinated against SARS-CoV-2.<br>• To compare the humoral immune response against wild-type SARS-CoV-2 between cohorts following 3rd vaccination dose in elderly individuals (=75 years) already vaccinated against SARS-CoV-2.<br>• To evaluate immune response against variants of concern of SARS-CoV-2 of different booster strategies in elderly individuals (=75 years) already fully vaccinated against SARS-CoV-2.<br>• To assess the CD4+ and CD8+ T cell response of different booster strategies in elderly individuals (=75 years) already vaccinated against SARS-CoV-2.<br>• To evaluate the long-term humoral immune response of different booster strategies in individuals already fully vaccinated against SARS-CoV-2.<br>;Main Objective: To evaluate immune response against wild-type SARS-CoV-2 of different booster strategies in elderly subjects (=75 years old) already fully vaccinated against SARS-CoV-2. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04384029 | 1 November 2021 | The Geneva Covid-19 CVD Study | Retrospective Observational Study to Compare the Short, Mid- and Long-term Prognosis and Outcomes of SRAS-CoV-2 Infected Hospitalized Patients With Cardiovascular Disease (CVD) to SARS-CoV-2 Infected Hospitalized Patients Without CVD: The Geneva Covid-19 CVD Study | | François MACH | 20/04/2020 | 20200420 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04384029 | Not recruiting | No | 18 Years | N/A | All | March 24, 2020 | 1927 | Observational | | | Switzerland | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Subject is =18 years of age.
<br>
<br> - Patient diagnosed SARS-CoV-2 positive at time of hospitalization.
<br>
<br> - In case of the subject accepting the follow-up at 30 days and 1 year, Signed Patient
<br> Informed Consent (PIC) form
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients unwilling to provide informed consent for the follow-up.
<br> | | COVID;CVD | Other: Covid-19 + patients | mobidity discharge;mobidity at 30 days;mobidity 1 year after hospitalization;mortality 1 year after hospitalization;mortality 30 days after hospitalization;mortality discharge | | | | Yes | False | | |
| → | NCT04394117 | 1 November 2021 | Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease | Controlled evaLuation of Angiotensin Receptor Blockers for COVID-19 respIraTorY Disease | CLARITY | The George Institute | 18/05/2020 | 20200518 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04394117 | Not recruiting | No | 18 Years | N/A | All | June 19, 2020 | 1500 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | Phase 4 | Australia;India;Australia;India→India;Australia;India;Australia | | Meg Jardine | | | | National Health and Medical Research Council, Australia |
<br> Inclusion Criteria:
<br>
<br> Potential participants must satisfy all of the following:
<br>
<br> 1. Laboratory-confirmed* diagnosis of SARS-CoV-2 infection within 10 days prior to
<br> randomisation
<br>
<br> 2. Age = 18 years
<br>
<br> 3. a) Systolic Blood Pressure (SBP) = 120 mmHg OR b) SBP = 115 mmHg and currently treated
<br> with a non-RAASi Blood Pressure (BP) lowering agent that can be ceased
<br>
<br> 4. Participant and treating clinician are willing and able to perform trial procedures.
<br>
<br> 5. Either Intended for hospital admission for management of COVID-19, or (In Australia
<br> Only) Intended for management at home with one or more of the following criteria:
<br>
<br> 1. Age=60 years
<br>
<br> 2. BMI =30kg/m2 (derived from the patient's self-report of their height and weight
<br> where these are not measured directly)
<br>
<br> 3. Diagnosis of diabetes defined as HbA1c =7% and/or the consumption of glucose
<br> lowering medication
<br>
<br> 4. History of cardiovascular disease
<br>
<br> 5. History of chronic respiratory illness
<br>
<br> 6. Currently treated with immunosuppression
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Currently treated with an ACEi, ARB or aldosterone antagonist, aliskiren, or
<br> angiotensin receptor-neprilysin inhibitors (ARNi)
<br>
<br> 2. Serum potassium > 5.2 mmol/L or no potassium testing within the last 3 months
<br>
<br> 3. For those intended for hospital admission, an estimated Glomerular Filtration Rate
<br> (eGFR) <30ml/min/1.73m2 or no eGFR testing within the last 3 months, or For those
<br> intended for management at home (Australia only), an eGFR <45ml/min/1.73m2 or no eGFR
<br> testing within the last 3 months
<br>
<br> 4. Known symptomatic postural hypotension
<br>
<br> 5. Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score
<br> 10-15) - see Table below
<br>
<br> 6. Intolerance of ARB
<br>
<br> 7. Pregnancy or risk of pregnancy, defined as;
<br>
<br> 1. (In Australia only) Women younger than 51 years who have not had a negative
<br> pregnancy test during the past 3 days and/or who do not agree to use adequate
<br> contraception
<br>
<br> 2. (In India Only) Women who are pregnant
<br>
<br> 8. Women who are currently breastfeeding
<br>
<br> 9. Individuals who are not able to take medications by mouth at enrolment, or who are not
<br> expected to be able to take medications by mouth during the first 48 hours after
<br> randomisation
<br> | | SARS-Cov-2;COVID-19 | Drug: Angiotensin Receptor Blockers;Other: Placebo | 7-Point National Institute of Health Clinical Health Score | | | | Yes | False | | |
| → | NCT04399889 | 1 November 2021 | hCT-MSCs for COVID19 ARDS | Pilot Study of Safety and Efficacy of Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC) in COVID-19 Related Acute Respiratory Distress Syndrome (ARDS) | | Joanne Kurtzberg, MD | 21/05/2020 | 20200521 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04399889 | Recruiting | No | 18 Years | N/A | All | June 18, 2020 | 50 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | United States | ; ; | Joanne Kurtzberg, MD;Lingye Chen, MD;Erin Arbuckle, MS | | ;;erin.arbuckle@dm.duke.edu | ;;919-684-3293 | Duke Health;Duke Health; |
<br> Inclusion Criteria:
<br>
<br> 1. The patient or legally authorized representative (LAR) must have the ability to
<br> understand and the willingness to provide a signed and dated informed consent form.
<br>
<br> 2. Age 18 years and over
<br>
<br> 3. The patient agrees to use adequate contraception for the duration of the treatment
<br> protocol and for 6 months post treatment.
<br>
<br> 4. Positive RT- PCR testing for COVID-19 nucleic acid using nasopharyngeal swabbing or
<br> any other site
<br>
<br> 5. Patient meets ARDS criteria and is on non-invasive or mechanical ventilation or high
<br> flow nasal cannula
<br>
<br> 1. bilateral opacities on chest imaging consistent with pulmonary edema
<br>
<br> 2. A need for positive pressure ventilation or high flow nasal cannula
<br>
<br> 3. PaO2/FiO2 ratio = 300 mmHg by arterial blood gas or SpO2/FiO2 imputation.
<br>
<br> 4. Infiltrates not fully explained by cardiac failure or fluid overload in the
<br> physician's best clinical judgement
<br>
<br> 6. Subjects requiring dialysis as a result of a COVID-19 infection will not be excluded.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Evidence of multiorgan failure involving one or more organs, excluding the lungs as
<br> defined below:
<br>
<br> 1. Presence of shock, defined as MAP < 65 mmHg with signs of peripheral
<br> hypoperfusion, or continuous infusion of 2 or more vasopressor or inotrope agents
<br> to maintain MAP = 65 mmHg.
<br>
<br> 2. Serum bilirubin > 10 mg/dl
<br>
<br> 3. Platelet count < 50,000/ml
<br>
<br> 4. Subjects requiring dialysis as a result of anything other than a COVID-19
<br> infection will be excluded
<br>
<br> 2. Evidence of acquired or congenital immunodeficiency (due to immunosuppressive therapy
<br> excluding steroid use for treatment of COVID-19 acute respiratory failure, HIV,
<br> previous treatment for cancer, etc.)
<br>
<br> 3. History of metastatic cancer diagnosis or treatment in the past 1 year
<br>
<br> 4. History of previous treatments with MSCs or other cell therapies
<br>
<br> 5. Patient is co-enrolled in any other IND-sponsored clinical trials for COVID-19 or
<br> ARDs. Drugs that are administered under emergency use authorizations (EUA) by the FDA
<br> are permitted.
<br>
<br> 6. Evidence of pregnancy or lactation
<br>
<br> 7. Moribund patient not expected to survive >24 hours
<br>
<br> 8. Unable/unwilling to deliver lung protective ventilation
<br>
<br> 9. Patient is receiving Extracorporeal Membrane Oxygenation (ECMO)
<br> | | COVID;Corona Virus Infection;COVID19 | Biological: Human cord tissue mesenchymal stromal cells (hCT-MSC) manufactured by Duke University.;Other: Placebo | Safety of the Investigational Product- Infusion Reactions;Safety of the Investigational Product- delayed reactions;Safety of the Investigational Product- formation of anti-HLA antibodies→Safety of the Investigational Product- formation of anti-HLA antibodies;Safety of the Investigational Product- delayed reactions;Safety of the Investigational Product- Infusion Reactions | | | | Yes | False | | |
| NCT04400305 | 1 November 2021 | "Increasing Physical Activity in Canadian Adults Affected by COVID-19 Social Distancing Restrictions: A Feasibility Trial of an Online Intervention" | "Increasing Physical Activity in Canadian Adults Who Have Been Affected by COVID-19 Social Distancing Restrictions: A Feasibility Trial of an Online Intervention" | COVID-19 | University of Victoria | 21/05/2020 | 20200521 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04400305 | Not recruiting | No | 18 Years | N/A | All | May 20, 2020 | 37 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Outcomes Assessor). | N/A | Canada | | | | | | |
<br> Inclusion Criteria:
<br>
<br> Potential participants will be included if they have:
<br>
<br> 1. started practising social distancing due to the current COVID-19 guidelines
<br>
<br> 2. are currently not meeting the physical activity (PA) guidelines (less than 150 minutes
<br> of moderate to vigorous aerobic activity)
<br>
<br> 3. participants must have access to the internet at home, and have a smart phone or home
<br> computer that can support the eHealth application we are using.
<br>
<br> Exclusion Criteria:
<br>
<br> Participants will be excluded from the project if:
<br>
<br> 1. they do not have access to the Internet,
<br>
<br> 2. are unable to speak/read English,
<br>
<br> 3. are engaging in moderate-to vigorous PA (MVPA) sufficient to meet the PA Guidelines,
<br>
<br> 4. have an existing chronic medical condition potentially making them at risk of injury
<br> or ill health from increasing their physical activity (this will be assessed using the
<br> GAQ. Screening completed formally over the phone, and participants will give their
<br> consent online)
<br> | | Physical Activity, Healthy Promotion | Behavioral: Digital Health Online Platform | Recruitment rate (monthly);Participant retention;Participant intervention satisfaction/evaluation | | | | Yes | False | | |
| NCT04402827 | 1 November 2021 | Different Susceptibility to SARS CoV-2 Infection Among Health Care Workers Highly Exposed to COVID-19. | Differences in Susceptibility to SARS CoV-2 Infection According to ACE2 and CD26 Receptors, Specific CD4/CD8 T Cell Response to Viral Peptides, and KIR Receptors Among Health Care Workers Highly Exposed to Patients With COVID-19 Diagnosis. | CoVEX | Asociacion para el Estudio de las Enfermedades Infecciosas | 23/05/2020 | 20200523 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04402827 | Not recruiting | No | 18 Years | 65 Years | All | August 1, 2020 | 140 | Observational | | | Spain | | Jose L Casado, MD, PhD | | | | Ramon y Cajal Physician |
<br> Inclusion criteria
<br>
<br> - HCW older than 18 years
<br>
<br> - Highly exposed to COVID-19 according to the definition
<br>
<br> - Negative (cases) or positive (controls) serology against SARS-CoV-2 infection
<br> Exclusion criteria
<br>
<br> - Presence of any disease / treatment which could alter the susceptibility (corticoid
<br> therapy, chemotherapy, monoclonal antibodies)
<br>
<br> - Pregnancy
<br>
<br> High exposure definition: direct and continued care of COVID-19 diagnosed patients for 2
<br> weeks or more, without aerosol- generating procedures, with inappropriate personal
<br> protective equipment (PPE), or unprotected exposure to patients with COVID-19 during
<br> aerosol-generating procedures.
<br>
<br> The definition of appropriate PPE was based on previous recommendations. The absence of any
<br> part of the PPE constituted an unprotected exposure. We defined the following as
<br> aerosol-generating procedures: airway suction, application of a high-flow O2 instrument,
<br> bronchoscopy, endotracheal intubation, tracheostomy, nebulizer treatment, sputum induction,
<br> positive pressure ventilation, manual ventilation and cardiopulmonary resuscitation.
<br> | | Health Care Worker Patient Transmission;Receptor Site Alteration;Susceptibility, Disease;Immune Response | Diagnostic Test: Susceptibility to infection | Susceptibility to SARS CoV-2 infection according to ACE2 receptor;Cellular immune response to SARS CoV-2 infection;Susceptibility to infections according to KIR phenoytpes | | | | Yes | False | | |
| → | NCT04414241 | 1 November 2021 | Hydroxychloroquine to Prevent SARS-CoV-2 Infection/COVID-19 | Hydroxychloroquine to Prevent SARS-CoV-2 Infection Among Healthcare Workers: Randomized Controlled, Open-label, Phase 3 Clinical Trial | | Universidad Peruana Cayetano Heredia | 01/06/2020 | 20200601 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04414241 | Not recruiting | No | 18 Years | N/A | All | June 25, 2020 | 68 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 3 | Peru | ; ; ; ; | Alejandro Llanos, MD, PhD;Eduardo Gotuzzo, MD;Max Grogl, PhD;Patricia García, MD, MPH, PhD;Manuel Espinoza, MD | | ;;;; | ;;;; | Universidad Peruana Cayetano Heredia;Universidad Peruana Cayetano Heredia;U.S. Naval Medical Research Unit Six;Universidad Peruana Cayetano Heredia;Instituto de Nacional de Salud |
<br> Inclusion Criteria:
<br>
<br> 1. Healthcare workers in service during the COVID-19 outbreak including medical, nurse,
<br> technical, and auxiliary staff.
<br>
<br> 2. Negative rapid serologic and molecular testing for SARS-CoV-2.
<br>
<br> 3. Written informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Presents COVID-19 symptoms including cough, fever, myalgias, headaches, loss of smell,
<br> and taste.
<br>
<br> 2. Prior (last 30 days), current or planned use (during study period) of
<br> hydroxychloroquine, chloroquine sulfate, or azithromycin.
<br>
<br> 3. Known cardiac disease or a history of prolonged QT syndrome.
<br>
<br> 4. Known allergy or intolerance to hydroxychloroquine and/or chloroquine sulfate.
<br>
<br> 5. Use of concomitant medications that are contraindicated with the use of
<br> hydroxychloroquine.
<br>
<br> 6. Other reported medical conditions, such as glucose-6-phosphate dehydrogenase
<br> deficiency, hepatic or renal insufficiency, or visual acuity or field disturbances,
<br> that make study participation not in the individual's best interest.
<br> | | SARS-CoV-2 | Drug: Hydroxychloroquine | Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2;Safety: Proportion of participants with grade 3 or more adverse events→Safety: Proportion of participants with grade 3 or more adverse events;Efficacy: Proportion of participants with positive molecular or serologic testing for SARS-CoV-2 | | | | Yes | False | | |
| NCT04415086 | 1 November 2021 | Treatment of Patients With COVID-19 With Convalescent Plasma | Treatment of Patients With COVID-19 With Convalescent Plasma Transfusion: a Multicenter, Open-labeled, Randomized and Controlled Study | COOPCOVID-19 | University of Sao Paulo General Hospital | 01/06/2020 | 20200601 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04415086 | Not recruiting | No | 18 Years | N/A | All | June 1, 2020 | 129 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | Brazil | | Esper G Kallás, PhD, MD | | | | University of Sao Paulo General Hospital |
<br> Inclusion Criteria:
<br>
<br> - Age = or > than 18 years; .
<br>
<br> - Laboratory-proven COVID-19 infection by RT-PCR in any clinical sample . Time since
<br> symptom onset less than 10 days at the time of screening; - . Presence of COVID-19
<br> pneumonia, with a typical, indeterminate or atypical compatible image in a chest
<br> tomography exam (see definition below) -
<br>
<br> - Presence of one of the following criteria:
<br>
<br> - Need for> 3L of O2 in the catheter / mask or> 25% in the Venturi mask to maintain O2
<br> saturation> 92% B presence of respiratory distress syndrome with PaO2 / FiO2 <300mmHg
<br> If intubated, within 48 hours of orotracheal intubation
<br>
<br> - Absence of a history of serious adverse reactions to transfusion, for example,
<br> anaphylaxis; - .Participation approval by the research clinician
<br>
<br> Exclusion Criteria:
<br>
<br> - Already enrolled in another clinical trial evaluating antiviral or immunobiological
<br> therapy for the treatment of COVID-19.
<br>
<br> - IgA deficiency
<br>
<br> - Presence of a clinical condition that does not allow infusion of 400 ml of volume at
<br> clinical discretion
<br>
<br> - Pregnancy or breastfeeding
<br>
<br> - Receipt of immunoglobulin in the last 30 days
<br>
<br> - Presence of significant risk of death within the next 48 hours at clinical discretion.
<br> | | COVID-19 | Biological: convalescent plasma | Time elapsed until clinical improvement or hospital discharge | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04514302 | 1 November 2021 | Safety and Efficacy of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) for Adult Patients With Mild COVID-19 | Phase I, Randomized, Placebo-controlled, Double-blind, Study to Evaluate the Safety and Antiviral Efficacy of Three Different Single Doses of Anti-SARS-CoV-2 Equine Antibody F(ab')2 Fragments (INOSARS) in Adult Patients With Mild COVID-19 | | Hospital San Jose Tec de Monterrey | 12/08/2020 | 20200812 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04514302 | Recruiting | No | 18 Years | 55 Years | All | October 27, 2021 | 30 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1 | Mexico | ; ; | José F Castilleja-Leal, MD;Servando Cardona-Huerta, MD, Ph. D.;Servando Cardona-Huerta, MD, PhD | | ;servandocardona@tec.mx;servandocardona@tec.mx | ;+5218112121946;+5218112121946 | Wellness and Prevention Center; |
<br> Key Inclusion criteria
<br>
<br> - Outpatient with a RT-qPCR confirmation of SARS-CoV-2 infection
<br>
<br> - Body Mass Index (BMI) at screening of 18.0 - 34.9 kg/m^2
<br>
<br> - Presence of at least one symptom consistent with COVID-19
<br>
<br> - Mild illness as defined by no requirement of supplementary oxygen or hospitalization
<br> criteria are met
<br>
<br> Key Exclusion criteria
<br>
<br> - Presence of a risk factor for disease progression documented for COVID-19 such as:
<br> uncontrolled diabetes, uncontrolled hypertension, cardiovascular disease, pulmonary
<br> disease, COPD, asthma, active cancer, immunosuppression, hypercoagulable states, CKD
<br> currently under dialysis
<br>
<br> - Documented allergy to equine serum proteins
<br>
<br> - Previous hospitalization due to COVID-19
<br>
<br> - Supplementary oxygen, invasive ventilation, or mechanical circulatory support
<br> requirements
<br>
<br> - Having received convalescent plasma or intravenous immunoglobulins for the treatment
<br> of COVID-19
<br>
<br> - Previous vaccination or plans to get vaccinated for COVID-19
<br>
<br> - In the opinion of investigator, other health conditions that suppose an increased risk
<br> of progression of disease
<br>
<br> NOTE: Other inclusion/exclusion criteria apply
<br> | | COVID-19 | Drug: Placebo;Drug: Anti-SARS-CoV-2 equine immunoglobulin F(ab')2 fragments (INOSARS) | Average change from baseline in viral load as quantified by RT-qPCR from nasopharyngeal swab samples;Proportion of patients with undetectable viral load as quantified by RT-qPCR from nasopharyngeal swab samples;Time of viral activity | | | | Yes | False | | |
| → | NCT04518410 | 1 November 2021 | ACTIV-2: A Study for Outpatients With COVID-19 | Adaptive Platform Treatment Trial for Outpatients With COVID-19 (Adapt Out COVID) | | National Institute of Allergy and Infectious Diseases (NIAID) | 17/08/2020 | 20200817 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04518410 | Recruiting | Yes | 18 Years | N/A | All | August 19, 2020 | 8797 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2/Phase 3 | United States;Argentina;Brazil;Canada;Mexico;Philippines;Puerto Rico;South Africa;Argentina;Brazil;Canada;Mexico;Philippines;Puerto Rico;South Africa;United States→United States;South Africa;Puerto Rico;Philippines;Mexico;Canada;Brazil;Argentina;South Africa;Puerto Rico;Philippines;Mexico;Canada;Brazil;Argentina;United States | | David Smith, MD, MAS | | | | University of California, San Diego |
<br> Inclusion Criteria:
<br>
<br> - Signed informed consent.
<br>
<br> - Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a
<br> molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g.
<br> oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva) collected =240 hours (10
<br> days) prior to study entry. Laboratory-confirmed SARS-CoV-2 infection outside the US
<br> must be conducted at a DAIDS-approved laboratory.
<br>
<br> - Able to begin study treatment no later than 7 days from self-reported onset of
<br> COVID-19 related symptom(s) or measured fever, where the first day of symptoms is
<br> considered symptom day 0 and defined by the self-reported date of first reported
<br> sign/symptom from the following list:
<br>
<br> - subjective fever or feeling feverish
<br>
<br> - cough
<br>
<br> - shortness of breath or difficulty breathing at rest or with activity
<br>
<br> - sore throat
<br>
<br> - body pain or muscle pain/aches
<br>
<br> - fatigue
<br>
<br> - headache
<br>
<br> - chills
<br>
<br> - nasal obstruction or congestion
<br>
<br> - nasal discharge
<br>
<br> - loss of taste or smell
<br>
<br> - nausea or vomiting
<br>
<br> - diarrhea
<br>
<br> - temperature > 38°C (100.4°F)
<br>
<br> - One or more of the following signs/symptoms within 24 hours of participating in the
<br> study:
<br>
<br> - subjective fever or feeling feverish
<br>
<br> - cough
<br>
<br> - shortness of breath or difficulty breathing at rest or with activity
<br>
<br> - sore throat
<br>
<br> - body pain or muscle pain/aches
<br>
<br> - fatigue
<br>
<br> - headache
<br>
<br> - chills
<br>
<br> - nasal obstruction or congestion
<br>
<br> - nasal discharge
<br>
<br> - loss of taste or smell
<br>
<br> - nausea or vomiting
<br>
<br> - diarrhea
<br>
<br> - temperature > 38°C (100.4°F)
<br>
<br> - Oxygen levels of =92% obtained at rest (adjusted as needed for altitude) by study
<br> staff within 24 hours of study entry. For a potential participant who regularly
<br> receives chronic supplementary oxygen for an underlying lung condition, their oxygen
<br> saturation should be measured while on their standard home oxygen supplementation
<br> level.
<br>
<br> - Participant must agree not to participate in another clinical trial for the treatment
<br> of COVID-19 or SARS-CoV-2 during the study period until hospitalization or 28 days
<br> after the start of the study, whichever occurs first.
<br>
<br> - Meet the protocol definition of being at "higher" risk of progression to
<br> hospitalization or death (BRII-196/BRII-198).
<br>
<br> - In Phase III, meeting the protocol definition of being at "higher" risk of progression
<br> to hospitalization or death (SNG001, SAB-185, BMS 986414+BMS 986413)
<br>
<br> - For participants of reproductive potential, negative serum or urine pregnancy test
<br> within 48 hours prior to study entry by any clinic or laboratory that has a CLIA
<br> certification or its equivalent, or by a point of care (POC)/CLIA-waived test. Note:
<br> Participants not of reproductive potential are eligible without requiring the use of a
<br> contraceptive method (BRII-196/BRII-198. AZD7442 [IV], AZD7442 [IM], SNG001, Camostat,
<br> SAB-185, BMS 986414+BMS 986413).
<br>
<br> - Participants that engage in sexual activity that may lead to pregnancy in their
<br> partner must agree to either remain abstinent or use male contraceptives. They are
<br> strongly advised to inform their non-pregnant sexual partners of reproductive
<br> potential to use effective contraceptives for 24 weeks after investigational product
<br> is administered. Participants with pregnant partners should use condoms during vaginal
<br> intercourse through 24 weeks after investigational agent administration. Participants
<br> should refrain from sperm donation for 24 weeks after investigational agent
<br> administration (BRII-196/BRII-198, AZD7442 [IV], AZD7442 [IM], SAB-185).
<br>
<br> - Participants that engage in sexual activity that may lead to pregnancy in their
<br> partner must agree to either remain abstinent or use male contraceptives for 30 days
<br> after investigational agent administration. They are also strongly advised to inform
<br> their non-pregnant sexual partners of reproductive potential to sue effective
<br> contraceptives for 30 days after investigational agent is administered to the
<br> participant. Participants with pregnant partners should use condoms during vaginal
<br> intercourse through 30 days after last dose of investigational agent administration.
<br> Participants should refrain from sperm donation for 30 days after investigational
<br> agent administration (SNG001).
<br>
<br> - Participants that engage in sexual activity that may lead to pregnancy in their
<br> partner must agree to either remain abstinent or use male contraceptives. They are
<br> also strongly advised to inform their non-regnant sexual partners of reproductive
<br> potential to use effective contraceptives from study entry through 90 days after study
<br> treatment. Participants with pregnant partners should use condoms during vaginal
<br> intercourse from study entry through 90 days after the last dose of the study
<br> treatment. Participants should refrain from sperm donation from study entry through 90
<br> days after the last dose of study treatment (Camostat).
<br>
<br> - If participating in sexual activity that could lead to pregnancy, participants who are
<br> of reproductive potential must agree to use effective contraception for 24 weeks after
<br> investigational agent is administered. This would include oral contraceptives,
<br> implanted contraceptives, implanted contraceptives, intrauterine devices, and barrier
<br> methods.
<br>
<br> - If participating in sexual activity that could lead to pregnancy, participants who are
<br> of reproductive potential must agree to use highly effective contraception for 24
<br> weeks after investigational agent is administered (AZD7442 [IV], AZD7442 [IM],
<br> SAB-185).
<br>
<br> - If participating in sexual activity that could lead to pregnancy, participants who are
<br> of reproductive potential must agree to use effective contraception for 30 days after
<br> investigational agent is administered (SNG001).
<br>
<br> - If participating in sexual activity that could lead to pregnancy, participants who are
<br> of reproductive potential must agree to use effective contraception for 90 days after
<br> the last dose of treatment (Camostat).
<br>
<br> - If participating in sexual activity that could lead to pregnancy, participants who are
<br> of reproductive potential must agree to use highly effective contraception for at
<br> least 48 weeks after the | | Coronavirus;Covid19 | Biological: bamlanivimab;Drug: Placebo (IV);Biological: BRII-196/BRII-198;Biological: AZD7442 (IV);Biological: AZD7442 (IM);Drug: SNG001;Drug: Camostat;Drug: Placebo (IM);Drug: Placebo (Inhaled solution);Drug: Placebo (oral tablet);Biological: BMS-986414 + BMS-986413;Drug: Placebo (SC injections);Biological: SAB-185 (3,840 Units/kg);Biological: SAB-185 (10,240 Units/kg);Drug: CASIRIVIMAB + IMDEVIMAB | Proportion of participants with new adverse event (AE) = Grade 3 (Phase 3);Cumulative incidence of death due to any cause or hospitalization due to any cause (Phase 3);Proportion of participants with new adverse event (AE) = Grade 3 (Phase 2);Quantification of SARS-CoV-2 RNA (Phase 2);Quantification of SARS-CoV-2 RNA (Phase 2);Quantification of SARS-CoV-2 RNA (Phase 2);COVID-19 symptom duration (Phase 2) | | | | Yes | True | parent | |
| NCT04526977 | 1 November 2021 | Differences in Immune Response Among HIV-1-infected Individuals With Previous or Current COVID-19 (CoVIHDis). | Differences in Susceptibility and Cytokine Profile, Specific CD4/CD8 T Cell Response, Toll Like Receptors (TLRs) and Killer Immunoglobulin-like Receptors (KIRs) Among HIV-1-infected Individuals With Previous or Current COVID-19 | CoVIHDis | Asociacion para el Estudio de las Enfermedades Infecciosas | 22/08/2020 | 20200822 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04526977 | Recruiting | No | 18 Years | 85 Years | All | January 10, 2021 | 90 | Observational | | | Spain | ; ; | Jose L Casado, PhD;Jose L Casado, PhD;Jose L Casado, Md, PhD | | ;jcasado.hrc@salud.madrid.org;jcasado.hrc@salud.madrid.org | ;0034913368672;34913368790 | Hospital Ramon y Cajal; |
<br> Inclusion Criteria:
<br>
<br> - adult (>18 year-old), confirmed HIV-1-infection, and provide written informed consent,
<br> with previous SARS CoV-2 infection as demonstrated by clinical and a positive PCR
<br> (cases) or no previous compatible symptoms and no diagnosis of SARS-CoV-2 infection
<br> (controls, classified according to serological determination)
<br>
<br> Exclusion Criteria:
<br>
<br> - unable to provide a written informed consent.
<br>
<br> - immunological alterations (chronic intake of corticoid or immunosuppresants)
<br> | | Covid19;Immune Suppression;HIV-1-infection | Diagnostic Test: Immune response study | Changes in immune cellular response | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04581200 | 1 November 2021 | Lift Mobile Mindfulness for COVID-19 Distress Symptoms | Addressing Psychological Distress Symptoms Among Serious Illness Survivors of a Viral Pandemic With a Completely Self-directed, Symptom-responsive Mobile Mindfulness Intervention: a Randomized Controlled Trial | LIFTCOVID | Duke University | 04/10/2020 | 20201004 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04581200 | Recruiting | No | 18 Years | N/A | All | January 25, 2021 | 300 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Investigator, Outcomes Assessor). | N/A | United States | ; | Christopher E Cox, MD;Christopher E Cox, MD | | ;Christopher.cox@duke.edu | ;9196817232 | Duke University; |
<br> BLUE CORAL eligibility (the parent cohort study from which RCT participants will be
<br> recruited)
<br>
<br> Inclusion criteria:
<br>
<br> 1. Adult hospitalized within 14 days of a positive PCR test for COVID-19
<br>
<br> 2. Evidence of acute COVID-19, with fever or respiratory manifestations, as characterized
<br> by signs and symptoms such as cough, dyspnea, tachypnea, hypoxemia, and infiltrates on
<br> chest imaging.
<br>
<br> Exclusion criteria:
<br>
<br> 1. Lack of informed consent
<br>
<br> 2. More than 72 hours of continuous hospitalization.
<br>
<br> 3. Comfort care orders in place at the time of enrollment and/or unexpected to survive
<br> for 24 hours
<br>
<br> 4. Prisoners
<br>
<br> 5. Previous enrollment in BLUE CORAL
<br>
<br> LIFT COVID RCT eligibility
<br>
<br> Inclusion criteria:
<br>
<br> 1. Enrolled in BLUE CORAL
<br>
<br> 2. Survival to time of BLUE CORAL 1-month post-discharge interview
<br>
<br> 2. English-speaking 3. Domiciled with access to a working telephone and smartphone, tablet,
<br> or computer with wifi or internet connection 4. Absence of severe dementia or cognitive
<br> dysfunction either before hospitalization or at time of 1 month post-discharge interview
<br>
<br> Exclusion criteria:
<br>
<br> 1. PHQ-9 <5 at time of interview 1 month post-discharge
<br>
<br> 2. Suicidal ideation at time of interview 1 month post-discharge
<br> | | COVID-19;Cardiorespiratory Failure | Behavioral: Lift | Change in Patient Health Questionnaire-9 Item scale (PHQ-9) | | | | Yes | False | | |
| → | NCT04590547 | 1 November 2021 | GLS-1027 for the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection (COVID-19) | Safety, Tolerability and Efficacy and Dose Response of GLS-1027 in the Prevention of Severe Pneumonitis Caused by SARS-CoV-2 Infection | | GeneOne Life Science, Inc. | 13/10/2020 | 20201013 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04590547 | Recruiting | No | 18 Years | N/A | All | May 7, 2021 | 132 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2 | United States;North Macedonia;Puerto Rico;North Macedonia;Puerto Rico;United States→United States;Puerto Rico;North Macedonia;Puerto Rico;North Macedonia;United States | | Medical Monitor | | jmaslow@genels.us | 610-707-5671 | |
<br> Inclusion Criteria:
<br>
<br> - Age 18 years or older
<br>
<br> - Able to provide consent
<br>
<br> - Able and willing to comply with study procedures
<br>
<br> - Diagnosis of PCR confirmed SARS-CoV-2
<br>
<br> - Enrollment within 72 of hospitalization
<br>
<br> - WHO COVID-19 classification level 3 or 4
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnant or lactating
<br>
<br> - Need for mechanical ventilation, non-invasive ventilation (NIV), or high-flow O2
<br> (=60%) via face mask
<br>
<br> - Calculated GFR < 60 (Cockcroft-Gault)
<br>
<br> - Meets treatment algorithm criteria for treatment with a non-study immune modulator
<br>
<br> - Pre-study or planned treatment with a non-study immune modulator
<br>
<br> - Participation in a COVID-19 clinical trial that includes prescription of a drug with
<br> anti-cytokine activity
<br>
<br> - Status post transplantation of an organ, bone marrow, or body part
<br>
<br> - Treatment within the past 60 days with a chemotherapeutic agent
<br>
<br> - Diagnosis of leukemia or lymphoma
<br>
<br> - WHO COVID-19 classification level of 5 or greater
<br>
<br> - Unable to take oral medication
<br>
<br> - Grade 3 or greater laboratory abnormalities as characterized by CTCAE v5
<br> | | Pneumonitis;SARS-CoV Infection | Drug: GLS-1027;Drug: Placebo | Incidence of treatment failure at day 28 from enrollment;Incidence of serious adverse events relative to treatment group | | | | Yes | False | | |
| NCT04595773 | 1 November 2021 | COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE) | COVID-19, Chronic Adaptation and Response to Exercise (COVID-CARE): A Randomized Controlled Trial | | National Institutes of Health Clinical Center (CC) | 20/10/2020 | 20201020 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04595773 | Recruiting | No | 18 Years | 80 Years | All | January 22, 2021 | 90 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Single (Participant). | Phase 1/Phase 2 | United States | ; ; | Leighton Chan, M.D.;COVID-CARE Rehab Team;For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) | | ;covidcarerehabteam@nih.gov;prpl@cc.nih.gov | ;Not Listed;800-411-1222 | National Institutes of Health Clinical Center (CC); |
<br> - INCLUSION CRITERIA:
<br>
<br> Screening procedures will be performed as part of this study. In order to be eligible to
<br> participate in this study, an individual must meet all of the following criteria:
<br>
<br> 1. Male or female, aged 18 to 80 years
<br>
<br> 2. Previous laboratory-confirmed infection with SARS-CoV2
<br>
<br> 3. Considered non-infectious with COVID-19 as demonstrated by:
<br>
<br> 1. Greater than or equal to 28 days since initial onset of symptoms or initial
<br> positive test date, (for asymptomatic infection), and greater than or equal to 72
<br> hours since resolution of fever (without fever-reducing medication), and symptoms
<br> (e.g. cough, shortness of breath) have improved, OR
<br>
<br> 2. Greater than or equal to 10 days since initial positive test date, and at least 2
<br> consecutive nasopharyngeal or oropharyngeal swabs collected greater than or equal
<br> to 24 hours apart that are negative for SARS-CoV2
<br>
<br> 4. Presence of physical limitations or significant fatigue since COVID-19 as demonstrated
<br> by:
<br>
<br> 1. Total score less than or equal to 19 on the PROMIS short form for physical
<br> function or total score greater than or equal to 9 on the PROMIS short form for
<br> fatigue, AND
<br>
<br> 2. Score greater than or equal to 1 on the Patient Global Rating of Flu Severity and
<br> Patient Global Assessment of Interference with Daily Activities
<br>
<br> 5. Able to read, speak and understand English or Spanish
<br>
<br> 6. Able to understand and willing to sign a written informed consent document
<br>
<br> 7. Willing and able to complete study procedures
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> An individual who meets any of the following criteria will be excluded from participation
<br> in this study:
<br>
<br> 1. Above normal performance (i.e, greater than or equal to 100% predicted) in the 6MWT
<br> based on normative data for gender and age (85,86)
<br>
<br> 2. History or cardiac condition as determined by NIH cardiology to be unsafe for exercise
<br> participation (e.g. ischemic heart disease, right- or left-sided heart failure, cor
<br> pulmonale or pulmonary hypertension, dilated or hypertrophic cardiomyopathy or
<br> non-idiopathic cardiomyopathy)
<br>
<br> 3. Significant hepatic or renal dysfunction
<br>
<br> 4. Cancer diagnosis with evidence of metastasis or a life expectancy of less than one
<br> year
<br>
<br> 5. History of stroke resulting in impairments in functional mobility that limits safe
<br> participation
<br>
<br> 6. Active substance abuse including EtOH
<br>
<br> 7. Severe psychiatric disease, not responsive to treatment or medication
<br>
<br> 8. History of diabetes and on insulin pump therapy, or uncontrolled diabetes with HbA1c >
<br> 9.0%
<br>
<br> 9. Pregnancy
<br>
<br> 10. Acceptance onto a lung transplant waiting list
<br>
<br> 11. Extreme obesity with BMI > 40 kg/m2
<br>
<br> 12. On medications that would influence exercise performance such as beta blockers or
<br> antiretroviral therapy
<br>
<br> 13. Ongoing tobacco and/or nicotine product use
<br>
<br> 14. Enrolled in another interventional clinical research trial
<br>
<br> 15. Any other medical or health condition(s) that unduly increases the risk of exercise
<br> testing or training, affects the normal physiologic response to exercise testing or
<br> training, and/or would otherwise interfere with the ability to interpret the data as
<br> determined by the PI
<br>
<br> INCLUSION OF VULNERABLE PARTICIPANTS:
<br>
<br> Participation of Employees:
<br>
<br> NIH employees may be enrolled in this study as this population meets the study entry
<br> criteria. Neither participation nor refusal to participate as a participant in the research
<br> will have an effect, either beneficial or adverse, on the participant s employment or
<br> position at NIH.
<br>
<br> Every effort will be made to protect participant information, but such information may be
<br> available in medical records and may be available to authorized users outside of the study
<br> team in both an identifiable and unidentifiable manner.
<br>
<br> The NIH Information Sheet on Employee Research Participation will be made available.
<br> | | COVID-19 | Other: Aerobic Exercise Training;Other: Education | 6 minute walk test distance | | | | Yes | False | | |
| → | NCT04596579 | 1 November 2021 | SARS-CoV-2 (COVID-19) Immune Surveillance Among a Population Based Sample of Adults in Florida | SARS-CoV-2 Immune Surveillance Among a Population Based Sample of Adults in Florida | | H. Lee Moffitt Cancer Center and Research Institute | 16/10/2020 | 20201016 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04596579 | Recruiting | No | 18 Years | N/A | All | October 17, 2020 | 1200 | Observational | | | United States | | Anna R Giuliano, PhD | | | | Moffitt Cancer Center |
<br> Inclusion Criteria:
<br>
<br> - Resident of Hillsborough County, Florida
<br>
<br> - 18 years of age or older
<br>
<br> - Currently not exhibiting symptoms of SARS-CoV-2 infection
<br> | | Coronavirus Infection | Diagnostic Test: SARS-CoV-2 Antibody Analysis;Diagnostic Test: Weck-cel Swab Collection;Behavioral: Web Based Questionnaire | Percentage of Participants who test positive for SARS-CoV-2 antibodies at second visit;Percentage of Participants who test positive for SARS-CoV-2 antibodies at third visit;Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit→Percentage of Participants who test positive for SARS-CoV-2 antibodies at third visit;Percentage of Participants who test positive for SARS-CoV-2 antibodies at second visit;Percentage of Participants who test positive for SARS-CoV-2 antibodies at first visit | | | | Yes | False | | |
| → | NCT04615949 | 1 November 2021 | Cannabidiol in Patients With COVID-19 and Cardiovascular Disease or Risk Factors | Study to Evaluate the Efficacy and Safety of CardiolRx™ in Patients With COVID-19 and Cardiovascular Disease or Risk Factors A Double-blind, Placebo-controlled Trial | | Cardiol Therapeutics Inc. | 02/11/2020 | 20201102 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04615949 | Recruiting | No | 18 Years | N/A | All | April 30, 2021 | 422 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States;Brazil;Mexico→Mexico;Brazil;United States | ; | Dennis McNamara, MD;Andrea B Parker, PhD | | ;andrea.parker@cardiolrx.com | ;289-910-0862 | University of Pittsburgh; |
<br> Inclusion Criteria:
<br>
<br> 1. Males and females 18 years of age or older
<br>
<br> 2. Tested positive and hospitalized for COVID-19 within the past 24 hours; illness
<br> severity must be less than indicated for intensive care unit (ICU) admission
<br>
<br> 3. Prior history of CVD [cardiovascular (CV), cerebrovascular or peripheral vascular
<br> diagnoses], and/or significant risk factors for CVD [age > 64, diabetes (DM),
<br> hypertension (HTN), abnormal serum lipids, obesity (BMI greater than 30)]
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients who have received vasopressors, extracorporeal membrane oxygenation and
<br> mechanical ventilation within last 30 days
<br>
<br> 2. Background of cardiac transplant surgery
<br>
<br> 3. Implanted defibrillator (ICD) in the last three months
<br>
<br> 4. Implanted left-ventricular assist device (LVAD)
<br>
<br> 5. Acute coronary syndrome (ACS) within 30 days
<br>
<br> 6. Percutaneous coronary intervention (PCI) within 30 days
<br>
<br> 7. Receiving any immuno-suppressive agent other than dexamethasone
<br>
<br> 8. History of QTc interval prolongation
<br>
<br> 9. QTc interval > 500 msec
<br>
<br> 10. Treated with strong inducers of CYP3A4 or CYP2C19, as listed in Appendix 17.8
<br>
<br> 11. Chronic renal failure, determined as eGFR < 60 ml/min
<br>
<br> 12. Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times
<br> the upper limit of normal (ULN) or ALT or AST >3x ULN plus bilirubin >2x ULN
<br>
<br> 13. Bacterial sepsis, defined as documented bacteremia at the time of presentation or
<br> other active bacterial infection
<br>
<br> 14. Current participation in any research study involving investigational drugs or devices
<br> with the exception of dexamethasone
<br>
<br> 15. Inability or unwillingness to give informed consent
<br>
<br> 16. Ongoing drug, alcohol or cannabis abuse
<br>
<br> 17. Women who are pregnant or breastfeeding
<br>
<br> 18. Any factor, which would make it unlikely that the patient can comply with the study
<br> procedures
<br>
<br> 19. Hemoglobin <8.5 gm/dL
<br>
<br> 20. Leukocyte count < 3000/ mm3
<br>
<br> 21. Platelets < 100,000 / mm3
<br>
<br> 22. Current diagnosis of cancer, with the exception of non-melanoma skin cancer
<br>
<br> 23. Showing suicidal tendency as per the Columbia-Suicide Severity Rating Scale (C-SSRS)
<br> administered at screening
<br> | | COVID-19;Cardiovascular Diseases;Cardiovascular Risk Factor | Drug: Cannabidiol, pharmaceutically produced with < 5 ppm THC;Drug: Placebo | All-cause mortality;CV complications;Requirement for ICU admission and/or ventilatory support→CV complications;Requirement for ICU admission and/or ventilatory support;All-cause mortality | | | | Yes | False | | |
| NCT04619680 | 1 November 2021 | The Study of the Use of Nintedanib in Slowing Lung Disease in Patients With Fibrotic or Non-Fibrotic Interstitial Lung Disease Related to COVID-19 | Early Nintedanib Deployment in COVID-19 Interstitial Lung Disease | ENDCOV-I | Icahn School of Medicine at Mount Sinai | 05/11/2020 | 20201105 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04619680 | Recruiting | No | 18 Years | N/A | All | November 18, 2020 | 170 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 4 | United States | ; | Maria Padilla, MD;ENDCOVI Study Team | | ;endcovi@mssm.edu | ;646-992-7222 | Icahn School of Medicine at Mount Sinai; |
<br> Inclusion Criteria:
<br>
<br> - Willing and able to provide written informed consent
<br>
<br> - Subjects Age > 18
<br>
<br> - Initial SARS-CoV-2 infection confirmed by PCR test or positive serologies
<br>
<br> - Have findings consistent with interstitial lung disease found on CT scan (these may
<br> include ground glass opacities, reticulations, traction bronchiectasis, septal
<br> thickening, and early honeycombing)
<br>
<br> - Required one of the following after diagnosis with SARS-CoV-2: supplemental oxygen by
<br> nasal cannula, high flow oxygen, non invasive ventilation such as CPAP or BIPAP, or
<br> mechanical ventilation
<br>
<br> - Are 30 days from onset of initial SARS-CoV-2 symptoms
<br>
<br> - Forced Vital Capacity less than or equal to 90% predicted based on ATS/ERS criteria or
<br> DLCO less than or equal to 70%
<br>
<br> - Women of childbearing potential who agree to use of highly effective contraception
<br> during treatment and for three months following the last dose of nintedanib
<br>
<br> Exclusion Criteria:
<br>
<br> Candidates will be excluded from study entry if any of the following exclusion criteria
<br> exist at the time of the Screening Visit (prior to randomization):
<br>
<br> - Co-administration of other investigational agents against COVID-19
<br>
<br> - Active SARS-CoV-2 infection based on clinical judgment
<br>
<br> - Currently Pregnant or Breast Feeding
<br>
<br> - Current Use of Prednisone or equivalent > 10 mg/daily
<br>
<br> - Use of full dose anticoagulation therapy or high dose anti platelet drug therapy at
<br> screening (at the discretion of the investigator, anticoagulation therapy may be added
<br> if clinically indicated)
<br>
<br> - History of myocardial infarction within past 90 days
<br>
<br> - Life threatening bleed
<br>
<br> - Hemodynamic instability or shock
<br>
<br> - Superimposed pulmonary bacterial infection
<br>
<br> - Pre-existing interstitial lung disease
<br>
<br> - Active Hep A/B/C hepatitis as measured with PCR for viral load and/or serologies
<br>
<br> - Pre-existing liver disease: Including Abnormal Laboratory Liver Function: Childs Pugh
<br> B/C, AST/ALT > 3 times the upper limit of normal (ULN). If Child Pugh A, can
<br> participate on Nintedanib 100 mg by mouth twice daily.
<br>
<br> - Subjects with a Creatinine clearance <30 ml/min or currently on hemodialysis
<br>
<br> - Inability to tolerate orally administered medication (medication must be taken with
<br> meals)
<br>
<br> - Patients who are in the intensive care unit (ICU) or in the step-down unit on invasive
<br> or non-invasive mechanical ventilation, ECMO, or high flow nasal cannula oxygen, will
<br> not be included.
<br>
<br> - Any condition that in the opinion of the Investigator, constitute a risk or a
<br> contraindication for the participation of the patient into the study or that could
<br> interfere with the study objectives, conduct or evaluation.
<br> | | Pulmonary Fibrosis;Interstitial Lung Disease;Respiratory Disease | Drug: Nintedanib;Drug: Placebo | Change in Forced Vital Capacity (FVC) | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04745351 | 1 November 2021 | Study to Evaluate the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for Coronavirus Disease 2019 (COVID-19) | A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter Study Evaluating the Efficacy and Safety of Remdesivir in Participants With Severely Reduced Kidney Function Who Are Hospitalized for COVID-19 | REDPINE | Gilead Sciences | 08/02/2021 | 20210208 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04745351 | Recruiting | No | 12 Years | N/A | All | March 31, 2021 | 1116 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 3 | United States;United Kingdom;Spain;Portugal;United Kingdom;Spain;Portugal;United States | ; | Gilead Study Director;Gilead Clinical Study Information Center | | ;GileadClinicalTrials@gilead.com | ;1-833-445-3230 (GILEAD-0) | Gilead Sciences; |
<br> Key Inclusion Criteria:
<br>
<br> - Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) positive as determined by
<br> Polymerase Chain Reaction (PCR) or other commercially available or public health assay
<br> (eg, Nucleic Acid Amplification Test (NAAT) and antigen tests) in any respiratory
<br> specimen
<br>
<br> - Hospitalized for COVID-19
<br>
<br> - Weighing at least 40 kilograms (kg)
<br>
<br> - Oxygen (O2) saturation = 94% on room air or requiring O2 supplement or Radiographic
<br> evidence of pulmonary infiltrates for COVID-19
<br>
<br> - Have either:
<br>
<br> - a) Severely reduced kidney function (estimated Glomerular Filtration Rate (eGFR)
<br> < 30 mL/min/1.73 m^2), including people with end-stage kidney disease (ESKD)
<br> requiring chronic dialysis
<br>
<br> - b) Ongoing acute kidney injury (AKI): defined as a 50% increase in serum
<br> creatinine (SCr) within a 48-hour period that is sustained (ie, requires
<br> confirmatory SCr) for = 6 hours despite supportive care
<br>
<br> - The interval between COVID-19 symptoms onset and randomization is no more than 10 days
<br>
<br> Key Exclusion Criteria:
<br>
<br> - Received any investigational drug, RDV, or other antiviral treatment for COVID-19
<br>
<br> - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper
<br> limit of normal
<br>
<br> - Invasive mechanical ventilation, noninvasive mechanical ventilation, ECMO, or RRT for
<br> acute kidney injury (AKI)
<br>
<br> - Positive serum pregnancy test at screening for women of childbearing potential or
<br> currently breastfeeding
<br>
<br> - Known hypersensitivity to the study drug, metabolites, or formulation
<br> sulfobutylether-beta-cyclodextrin (SBECD)
<br>
<br> Note: Other protocol defined Inclusion/Exclusion criteria may apply
<br> | | COVID-19 | Drug: Remdesivir;Drug: RDV Placebo;Drug: Standard of Care | Composite of All-Cause Mortality or Invasive Mechanical Ventilation (IMV) Through Day 29 | | | | Yes | False | | |
| → | NCT04756271 | 1 November 2021 | Safety and Immunogenicity of Oxford AstraZeneca Vaccine Against COVID-19 Infection | Safety and Immunogenicity of Oxford AstraZeneca Vaccine in Zagazig University Hospital Health-care Workers | | Zagazig University | 13/02/2021 | 20210213 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04756271 | Recruiting | No | 18 Years | N/A | All | February 11, 2021 | 140 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 3 | Egypt | ; ; | Noha M Hammad, MD;Doaa A Aboalella, MD;Noha Mohamed El S Hammad | | ;daaboelelaa@medicine.zu.edu.eg; | ;01223512499;01224264909 | Faculty of Medicine, Zagazig University , Zagazig, Egypt; |
<br> Inclusion Criteria:
<br>
<br> -Healthy healthcare workers
<br>
<br> Exclusion Criteria:
<br>
<br> - Healthy healthcare workers' refusal.
<br>
<br> - Pregnancy and lactation.
<br>
<br> - Confirmed acute cases of SARS-CoV-2 Infection
<br>
<br> - Having a history of SARS-CoV-2 infection in the past 3 months.
<br>
<br> - Fever (body temperature > 37.0 ?), dry cough, fatigue, nasal obstruction, runny nose,
<br> pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14
<br> days before vaccination.
<br>
<br> - History of allergy to any vaccines
<br>
<br> - Previous vaccination within the last 30 days
<br> | | Vaccine Adverse Reaction;Seroconversion | Biological: SARS-Cov-2 neutralizing antibody titer | Incidence of adverse reactions;Seroconversion rate of neutralizing antibody→Seroconversion rate of neutralizing antibody;Incidence of adverse reactions | | | | Yes | False | | |
| NCT04761718 | 1 November 2021 | Covid-19 Epidemic Lockdown Impact on Psychomotor Performance | Covid-19 Epidemic Lockdown Impact on Psychomotor Performance in Egyptian Children | | Delta University for Science and Technology | 17/02/2021 | 20210217 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04761718 | Not recruiting | No | 6 Years | 18 Years | All | October 22, 2021 | 300 | Observational | | | | | Amira Hussin Mohammed, PHD | | amira_hussin77@yahoo.com | 02001144495063 | |
<br> Inclusion Criteria:
<br>
<br> 100 participants will be chosen according to the following criteria : subject in both sexes
<br> and their age will ranged between
<br>
<br> 1. 6-9 years.
<br>
<br> 2. 10-13 years.
<br>
<br> 3. 14-18 years All subjects should be clinically and medically stable
<br>
<br> Exclusion Criteria:
<br>
<br> Subjects with psychological or Motor impairment will be excluded from the study.
<br> | | Covid19 Epidemic Lockdown Impact | | post lockdown assessment for physical activity;pre lockdown assessment for physical activity | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04773067 | 1 November 2021 | A Study to Evaluate UB-612 COVID-19 Vaccine in Adolescent, Younger and Elderly Adult Volunteers | A Phase II, Placebo-controlled, Randomized, Observer-blind Study to Evaluate the Immunogenicity, Safety, and Tolerability of UB-612 Vaccine Against COVID-19 in Adolescent, Younger and Elderly Adult Volunteers | | United Biomedical Inc., Asia | 23/02/2021 | 20210223 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04773067 | Recruiting | No | 12 Years | 85 Years | All | January 30, 2021 | 3850 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 2 | Taiwan | ; | Chang-Yi Wang, Ph.D.;Hope Liu, Ph.D. | | ;hope.liu@ubiasia.com.tw | ;+886-3-657-8861 | United Biomedical; |
<br> Inclusion Criteria:
<br>
<br> - Healthy male or non-pregnant female between the age of 12 to 85 years at time of
<br> enrolment.
<br>
<br> - Women of childbearing potential and men must agree to practice medically effective
<br> contraception from first vaccination until 3 months after the last vaccination.
<br>
<br> - Able to understand the content and possible risks of informed consent and willing to
<br> sign the Informed Consent Form (ICF).
<br>
<br> - Able to understand and agrees to comply with all study procedures and be available for
<br> all study visits.
<br>
<br> - Ear temperature = 38.0°C.
<br>
<br> - Healthy participants who are determined by medical history, physical examination, and
<br> clinical judgment of the investigator to be eligible for inclusion in the study. In
<br> the investigator's clinical judgement, participant may have a stable and
<br> well-controlled comorbidity associated with an increased risk of progression to severe
<br> COVID-19.
<br>
<br> Exclusion Criteria:
<br>
<br> - History of anaphylaxis, urticarial, or other significant adverse reaction requiring
<br> medical intervention after receipt of a vaccine.
<br>
<br> - Female who is pregnant or positive in pregnancy test at screening or just prior to
<br> each vaccination administration.
<br>
<br> - Female who is breast-feeding or plans to breastfeed from the time of the first
<br> vaccination through 60 days after the last vaccination.
<br>
<br> - Any acute illness, as determined by the study investigator 3 days before first
<br> vaccination (these subjects can be re-scheduled).
<br>
<br> - Any major surgery one month before first vaccination (these subjects can be
<br> -rescheduled).
<br>
<br> - Known HIV antibody positive.
<br>
<br> - Known active hepatitis B and hepatitis C disease.
<br>
<br> - Previous exposure to SARS-CoV-2 or receipt of an investigational or licensed product
<br> for the prevention of COVID-19, MERS or SARS.
<br>
<br> - Have history of Guillain-Barre syndrome.
<br>
<br> - Subjects who take part in another clinical study within 12 weeks prior to the day of
<br> informed consent.
<br>
<br> - Immune deficiency/disorder, whether due to genetic defect, immunodeficiency disease or
<br> immunosuppressive therapy.
<br>
<br> - Subjects who plan to or are undergoing anti-cancer therapy.
<br>
<br> - Platelet disorder or other bleeding disorder may cause injection contraindication.
<br>
<br> - Prior chronic administration of immunosuppressant or corticosteroids, cytotoxic
<br> treatment in last 6 months before first vaccination.
<br>
<br> - Prior administration of immunoglobulins and/or any blood products in last 4 months
<br> before first vaccination.
<br>
<br> - Receipt of any seasonal or pandemic influenza vaccine within 14 days, or any other
<br> non-study vaccine within 28 days, before study intervention administration.
<br>
<br> - Anticipated receipt of any seasonal or pandemic influenza vaccine within 14 days, or
<br> any other nonstudy vaccine within 28 days, after study intervention administration.
<br>
<br> - Receipt of short-term (<14 days) systemic corticosteroids. Study intervention
<br> administration should be delayed until systemic corticosteroid use has been
<br> discontinued for at least 28 days. Inhaled/nebulized, intra-articular, intrabursal, or
<br> topical (skin or eyes) corticosteroids are permitted.
<br>
<br> - Loss or donation of blood over 500 mL within 3 months prior to Screening Visit or
<br> intention to donate blood or blood products for transfusion during the study.
<br>
<br> - Any medical disease or condition that, in the opinion of the study investigator, may
<br> confound the results of the study or pose an additional risk to the subjects by their
<br> participation in the study.
<br>
<br> - Employees at the investigator's site, of the Sponsor or the contract research
<br> organization (CRO) who directly involved in the conduct of the study.
<br> | | COVID-19 | Biological: UB-612;Biological: Placebo | Safety evaluation;Safety evaluation;Seroconversion rate (SCR) of SARS-CoV-2 neutralizing antibody;Geometric mean titer (GMT) of SARS-CoV-2 neutralizaing antibody | | | | Yes | False | | |
| → | NCT04818164 | 1 November 2021 | Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Acute Respiratory Distress Syndrome | Prone Position Improves End-Expiratory Lung Volumes in COVID-19 Associated Acute Respiratory Distress Syndrome: An Observational Study | | Istanbul University-Cerrahpasa | 25/03/2021 | 20210325 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04818164 | Not recruiting | No | 18 Years | N/A | All | September 1, 2020 | 43 | Observational | | | Turkey | | Olcay Dilken, Dr. | | | | Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine |
<br> Inclusion Criteria:
<br>
<br> - Patients were considered eligible if they met the Berlin definition criteria for ARDS
<br> and intubated due to increased work of breathing and/or worsening hypoxemia. All
<br> patients had a positive Covid-19 real time Polymerase Chain Reaction test
<br>
<br> Exclusion Criteria:
<br>
<br> - Exclusion criteria were; age < 18 years, ARDS resulting from other risk factors,
<br> presence of chest drainage tubes, tracheostomy, pneumomediastinum, hemodynamic
<br> instability (systolic blood pressure < 100 mmHg, lactate > 2 mmol/l, or an increase in
<br> lactate concentrations for 20% in two consecutive blood gas analysis within 2 hours
<br> interval) and suspicion or confirmed pulmonary emboli.
<br> | | Acute Respiratory Distress Syndrome;Coronavirus;Mechanical Ventilation Complication;Ventilation Perfusion Mismatch | | Partial Pressure of Oxygen/ Fraction of Inspired Oxygen;End Expiratory Lung Volume→End Expiratory Lung Volume;Partial Pressure of Oxygen/ Fraction of Inspired Oxygen | | | | No | False | | |
| NCT04838106 | 1 November 2021 | Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales | Outcomes of Patients Who Survived Treatment on an Intensive Care Unit for COVID-19 in England and Wales: a Comparative Retrospective Cohort Study (OPTIC-19) | OPTIC-19 | University of Oxford | 07/04/2021 | 20210407 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04838106 | Not recruiting | No | 16 Years | N/A | All | August 1, 2020 | 319600 | Observational | | | United Kingdom | | Peter Watkinson, MD | | | | University of Oxford |
<br> Inclusion Criteria:
<br>
<br> - Age 16 years or over
<br>
<br> - Admitted to an adult, general ICU in England or Wales as an emergency (unplanned)
<br>
<br> - Admitted to ICU for either: a) confirmed COVID-19 between 1st January to 1st July 2020
<br> or b) without confirmed COVID-19 between 1st July 2016 and 1st July 2020-
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who died in hospital after treatment on an ICU
<br> | | Covid19;Myocardial Infarction;Stroke;Critical Illness;Heart Failure;Deep Vein Thrombosis;Pulmonary Embolism;Renal Failure | Other: Not applicable as observational study | Mortality Rate | | | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04952389 | 1 November 2021 | Acupuncture Therapy for COVID-Related Olfactory Loss | Acupuncture Therapy for COVID-Related Olfactory Loss | | Mayo Clinic | 02/07/2021 | 20210702 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04952389 | Recruiting | No | 18 Years | N/A | All | December 2021 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United States | ; | Janalee Stokken, MD;Amy Tuchscherer | | ;Tuchscherer.Amy@mayo.edu | ;507-538-6582 | Mayo Clinic |
<br> Inclusion Criteria:
<br>
<br> - 18 years or older.
<br>
<br> - Patients with post-viral olfactory dysfunction > 4 weeks.
<br>
<br> - History of positive COVID-19 PCR.
<br>
<br> Exclusion Criteria:
<br>
<br> - Less than 18 years of age.
<br>
<br> - Active sinus infection.
<br>
<br> - New diagnosis of untreated CRS.
<br>
<br> - Prior diagnosis of dementia or Parkinson's disease.
<br>
<br> - Prior head trauma or neurosurgical procedure resulting in olfactory loss.
<br>
<br> - Patients who do not speak or read English.
<br>
<br> - Patients unable to understand and sign the study consent.
<br> | | Olfactory Dysfunction;COVID-19 | Device: Acupuncture Therapy;Drug: Budesonide;Other: Olfactory Training | Change in UPSIT scores | | | | Yes | False | | |
| → | NCT04956224 | 1 November 2021 | Immunogenicity of VLA2101 Compared to VLA2001. | A Randomized, Observer-Blind, Controlled, Non-Inferiority Study To Compare The Immunogenicity Against COVID-19, Of VLA2101 Vaccine To VLA2001 Vaccine, In Volunteers Aged =12 Years. | | Valneva Austria GmbH | 21/06/2021 | 20210621 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04956224 | Not recruiting | No | 12 Years | N/A | All | August 9, 2021 | 900 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | New Zealand | | Valneva Clinical Deveopment | | | | Valneva Austria GmbH |
<br> Inclusion Criteria:
<br>
<br> 1. Parent(s)/legal representative(s) and participants who have an understanding of the
<br> study and its procedures as explained by the investigator and agree to its provisions:
<br>
<br> 2. Cohort 1: Participants of either gender aged 56 years or older at screening. Cohort 2:
<br> Participants of either gender aged 12 years or older at screening.
<br>
<br> 3. Medically stable such that, according to the judgment of the investigator,
<br> hospitalization within the study period is not anticipated and the participant appears
<br> likely to be able to remain on study through the end of protocol-specified follow-up.
<br>
<br> 4. Participant has a Body Mass Index (BMI) of 18.0-35.0 kg/m2, inclusive, at screening.
<br>
<br> 5. Must be able to attend all visits of the study and comply with all study procedures,
<br> including daily completion of the e-diary for 7 days following each vaccination.
<br>
<br> 6. Women of childbearing potential (WOCBP), who are sexually active with a man, must be
<br> able and willing to use at least 1 highly effective method of contraception from study
<br> start until a minimum of 3 months after the last dose of study vaccine.
<br>
<br> 7. WOCBPs must have a negative pregnancy test prior to each vaccination.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Participant is pregnant or planning to become pregnant within 3 months after last
<br> study vaccine administration.
<br>
<br> 2. History of allergy to any component of the vaccine.
<br>
<br> 3. History of laboratory-confirmed SARS-CoV infection
<br>
<br> 4. Participant had close contact to persons with confirmed SARS-CoV-2 infection within 30
<br> days prior to screening.
<br>
<br> 5. Participant has participated in a clinical study involving an investigational
<br> SARS-CoV-2 vaccine or has received or plans to receive a licensed SARS-CoV-2 vaccine
<br> during the duration of the study.
<br>
<br> 6. Significant infection (e.g. positive SARS-CoV-2 RT-PCR) or other acute illness,
<br> including fever > 100 °F (> 37.8 °C) 48 hours before vaccination.
<br>
<br> 7. Participant has a known or suspected defect of the immune system, such as participants
<br> with congenital or acquired immunodeficiency, including infection with HIV, status
<br> post organ transplantation or immuno-suppressive therapy within 4 weeks prior to the
<br> expected day of randomization.
<br>
<br> 8. Participant has a history of malignancy in the past 5 years other than squamous cell
<br> or basal cell skin cancer. If there has been surgical excision or treatment more than
<br> 5 years ago that is considered to have achieved a cure, the participant may be
<br> enrolled.
<br>
<br> 9. History of drug dependency or current use of drug of abuse or alcohol abuse at
<br> screening.
<br>
<br> 10. Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma
<br> within 6 weeks prior to the expected day of randomization.
<br>
<br> 11. History of clinically significant bleeding disorder (e.g., factor deficiency,
<br> coagulopathy, or platelet disorder), or prior history of significant bleeding or
<br> bruising following IM injections or venipuncture.
<br>
<br> 12. Severe and uncontrolled ongoing autoimmune or inflammatory disease, History of
<br> Guillain-Barre syndrome or any other demyelinating condition.
<br>
<br> 13. Any other significant disease, disorder or finding which in the opinion of the
<br> investigator may significantly increase the risk to the volunteer because of
<br> participation in the study, affect the ability of the volunteer to participate in the
<br> study or impair interpretation of the study.
<br>
<br> Prior/concomitant therapy:
<br>
<br> 14. Receipt of immunoglobulin or another blood product within the 3 months before expected
<br> day of randomization (visit 1) in this study or those who expect to receive
<br> immunoglobulin or another blood product during this study.
<br>
<br> 15. Receipt of medications and or vaccinations intended to prevent COVID-19.
<br>
<br> 16. Receipt of any vaccine (licensed or investigational), other than licensed influenza
<br> vaccine or for medical emergencies such as tetanus or rabies exporsure, within 28 days
<br> prior to the expected day of randomization.
<br>
<br> Others:
<br>
<br> 17. Any member of the study team or sponsor.
<br>
<br> 18. An immediate family member or household member of the study's personnel.
<br> | | SARS-CoV-2 Virus Infection | Biological: VLA2001;Biological: VLA2101 | Immune response as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies;Frequency and severity of solicited AES (local and systemic reactions) after each and any vaccination→Frequency and severity of solicited AES (local and systemic reactions) after each and any vaccination;Immune response as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies | | | | Yes | False | | |
| NCT04962347 | 1 November 2021 | Real World Study of COVID-19 in a Flyover Region | Real World Study of COVID-19 in a Flyover Region | | Tulane University | 12/07/2021 | 20210712 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04962347 | Recruiting | No | 18 Years | 120 Years | All | October 14, 2021 | 10000 | Observational | | | United States | ; ; | Arnaud Drouin, MD, PhD;Arnaud Drouin, MD, PhD;Arnaud Drouin, MD, PhD | | ;adrouin@tulane.edu;adrouin@tulane.edu | ;504-988-7316;504-988-7316 | Tulane University; |
<br> Inclusion Criteria:
<br>
<br> - Positive qRT PCR for COVID-19 from a nasopharyngeal, nasal, or oropharyngeal swab or
<br> from bronchoalveolar lavage.
<br>
<br> - Received RDV (cases) or did not receive RDV (controls).
<br>
<br> - Age = 18 years
<br>
<br> Exclusion Criteria:
<br>
<br> - None.
<br> | | Covid19 | | The change of clinical severity, as measured using 7-point ordinal clinical severity scale, from first RDV dose through day 11 post-dose. | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT04974164 | 1 November 2021 | Effectiveness of COVID-19 Vaccine for Prevention of COVID-19 in the Dominican Republic | Effectiveness of COVID-19 Vaccine (Vero Cell), Inactivated (CoronaVac) for Preventing Symptomatic SARS-CoV-2 Infections and Hospitalizations in the Dominican Republic - Test-Negative Case-Control Study | | Sinovac Research and Development Co., Ltd. | 22/07/2021 | 20210722 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04974164 | Recruiting | No | 18 Years | N/A | All | August 17, 2021 | 1400 | Observational | | | Dominican Republic | ; | Eddy Perez-Then, Doctor;Eddy Perez-Then, Doctor | | ;conabios_rd@yahoo.com | ;+1 (809) 682-8849 | Ministry of Health; |
<br> Inclusion Criteria:
<br>
<br> - Aged =18 years;
<br>
<br> - Permanent residents of study provinces;
<br>
<br> - Able and willing to provide informed consent to participate in the study;
<br>
<br> - Able and willing to provide nasopharyngeal swab and venous blood sample;
<br>
<br> - Able and willing to complete a questionnaire survey for collecting information on
<br> histories of COVID-19 vaccination and disease;
<br>
<br> - Considered as suspected cases of SARS-CoV-2 infections by the physicians in the study
<br> clinics according to DR national protocol.
<br>
<br> Exclusion Criteria:
<br>
<br> -
<br> | | COVID-19 | Biological: Inactivated COVID-19 Vaccine | Protective effectiveness of complete vaccination of CoronaVac against COVID-19 hospitalizations and severe cases.;Protective effectiveness of complete vaccination of CoronaVac against symptomatic SARS-COV-2 infections | | | | Yes | False | | |
| → | NCT04980534 | 1 November 2021 | Evaluation of the Effectiveness of Therapy for Patients With Covid-19 Using Food Supplements Viusid + Asbrip | Evaluation of the Effectiveness of Therapy for Patients With Covid-19 Using Food Supplements Viusid + Asbrip | | Catalysis SL | 26/07/2021 | 20210726 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04980534 | Not recruiting | No | 18 Years | N/A | All | January 8, 2021 | 80 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | Kazakhstan | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female adult aged =18 years at the time of enrollment.
<br>
<br> 2. Subjects with mild-to-moderate symptoms of respiratory illness caused by coronavirus
<br> 2019 infection as defined below:
<br>
<br> Mild (uncomplicated) Illness:
<br>
<br> - Diagnosed with COVID-19 by a standardized RT-PCR assay and
<br>
<br> - Mild symptoms, such as fever, rhinorrhea, mild cough, sore throat, malaise,
<br> headache, muscle pain, or malaise, but with no shortness of breath and
<br>
<br> - No signs of a more serious lower airway disease and
<br>
<br> - RR<20, HR <90, oxygen saturation (pulse oximetry) > 93% on room air.
<br>
<br> Moderate Illness:
<br>
<br> - Diagnosed with COVID-19 by a standardized RT-PCR assay and
<br>
<br> - In addition to symptoms above, more significant lower respiratory symptoms,
<br> including shortness of breath (at rest or with exertion) or
<br>
<br> - Signs of moderate pneumonia, including RR = 20 but <30, HR = 90 but less than
<br> 125, oxygen saturation (pulse oximetry) > 93% on room air and
<br>
<br> - If available, lung infiltrates based on X-ray or CT scan < 50% present
<br>
<br> 3. Clinically normal resting 12-lead ECG at screening visit or, if abnormal, considered
<br> not clinically significant by the Principal Investigator.
<br>
<br> 4. Subject (or legally authorized representative) provides written informed consent prior
<br> to initiation of any study procedures.
<br>
<br> 5. Understands and agrees to comply with planned study procedures.
<br>
<br> 6. Women of childbearing potential must agree to use at least one medically accepted
<br> method of contraception (e.g., barrier contraceptives [condom, or diaphragm with a
<br> spermicidal gel], hormonal contraceptives [implants, injectables, combination oral
<br> contraceptives, transdermal patches, or contraceptive rings], or intrauterine devices)
<br> for the duration of the study.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subjects showing signs of acute respiratory distress syndrome (ARDS) or respiratory
<br> failure necessitating mechanical ventilation at the time of screening
<br>
<br> 2. History of severe chronic respiratory disease and requirement for long-term oxygen
<br> therapy
<br>
<br> 3. Subjects showing signs of clinical jaundice at the time of screening.
<br>
<br> 4. History of moderate and severe liver disease (Child-Pugh score >12)
<br>
<br> 5. Subjects requiring Renal Replacement Therapy (RRT) at the time of screening
<br>
<br> 6. History of uncontrolled diabetes
<br>
<br> 7. History of severe chronic kidney disease or requiring dialysis
<br>
<br> 8. Any uncontrolled active systemic infection requiring admission to an intensive care
<br> unit (ICU); Note: Subjects infected with chronic hepatitis B virus or hepatitis C
<br> virus will be eligible for the study if they have no signs of hepatic decompensation.
<br>
<br> 9. Patients with malignant tumor, or other serious systemic diseases
<br>
<br> 10. Patients who are participating in other clinical trials
<br>
<br> 11. Patients who have a history of allergic reactions attributed to compounds of similar
<br> chemical or biologic composition to Viusid or Asbrip are not eligible; and
<br>
<br> 12. Inability to provide informed consent or to comply with test requirements
<br> | | Covid19;COVID-19 Pneumonia;COVID-19 Respiratory Infection;Viral Infection;Respiratory Tract Infections;Infection, Coronavirus;SARS-CoV2 Infection | Dietary Supplement: Viusid and Asbrip;Drug: COVID-19 Standard Therapy | Clinical symptoms related with COVID-19 disease;Symptoms resolution;Time to recovery;Time to semi-recovery→Time to semi-recovery;Time to recovery;Symptoms resolution;Clinical symptoms related with COVID-19 disease | | | | Yes | False | | |
| → | NCT04988152 | 1 November 2021 | A Study to Investigate the PK, Safety, and Tolerability of Sotrovimab vs Placebo Administered IV or IM in Japanese and Caucasian Participants | A Phase I, Single-blind, Randomized, Single-dose Clinical Pharmacology Study to Investigate the Pharmacokinetics, Safety, and Tolerability of Sotrovimab vs Placebo by Intravenous or Intramuscular Administration in Healthy Japanese and Caucasian Participants | | Vir Biotechnology, Inc. | 26/07/2021 | 20210726 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04988152 | Not recruiting | No | 18 Years | 65 Years | All | July 6, 2021 | 40 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant). | Phase 1 | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Male or female participants, aged 18 to 65 years, inclusive
<br>
<br> - Participants who are healthy as determined by medical evaluation including medical
<br> history, physical examination, laboratory tests, and cardiac monitoring.
<br>
<br> - Japanese participants must be of Japanese ancestry, defined as having been born in
<br> Japan, being descendants of four ethnic Japanese grandparents and two ethnic Japanese
<br> parents, holding a Japanese passport or identity papers, and being able to speak
<br> Japanese. Participants should have lived outside Japan for fewer than 10 years at the
<br> time of Screening.
<br>
<br> - Caucasian participants must be of Caucasian ancestry, defined as Caucasian descent as
<br> evidenced by appearance and verbal confirmation of familial heritage.
<br>
<br> - Body mass index (BMI) within the range of 18 to 29.9 kg/m2 (inclusive).
<br>
<br> - Capable of giving signed informed consent, which includes compliance with the
<br> requirements and restrictions listed in the consent form and protocol.
<br>
<br> Exclusion Criteria:
<br>
<br> - History or presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal,
<br> endocrine, hematological, or neurological disorders capable of significantly altering
<br> the absorption, metabolism, or elimination of drugs; constituting a risk when taking
<br> the study intervention or interfering with the interpretation of data.
<br>
<br> - Lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or
<br> squamous epithelial carcinomas of the skin that have been resected with no evidence of
<br> metastatic disease for 3 years.
<br>
<br> - Breast cancer within the past 10 years.
<br>
<br> - Abnormal blood pressure at Screening.
<br>
<br> - Significant allergies to humanized monoclonal antibodies.
<br>
<br> - Clinically significant multiple or severe drug allergies, intolerance to topical
<br> corticosteroids, or severe post-treatment hypersensitivity reactions (including, but
<br> not limited to, erythema multiforme major, linear immunoglobulin A (IgA) dermatosis,
<br> toxic epidermal necrolysis, and exfoliative dermatitis).
<br>
<br> - Current or chronic history of liver disease or known hepatic or biliary abnormalities
<br> (with the exception of Gilbert's syndrome or asymptomatic gallstones).
<br>
<br> - Use of any prescription medications (besides contraceptive medications or devices)
<br> within the 28 days prior to dosing or concomitantly, unless permitted by the protocol
<br> or approved by the Investigator in conjunction with the GSK medical monitor.
<br>
<br> - Treatment with biologic agents (such as monoclonal antibodies including marketed
<br> drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
<br>
<br> - Receipt of convalescent plasma from a recovered COVID-19 patient or anti-SARSCoV- 2
<br> mAb within the last 3 months.
<br>
<br> - Receipt of any vaccine within 48 hours prior to enrollment. Vaccination will not be
<br> allowed for 90 days after dosing.
<br>
<br> - Participant has received a SARS-CoV-2 vaccine but has not completed all doses in the
<br> series more than 28 days prior to Screening
<br>
<br> - Participation in the study would result in loss of blood or blood products in excess
<br> of 500 mL within a 56 day period.
<br>
<br> - Exposure to more than 4 new chemical entities within 12 months prior to the first
<br> dosing day.
<br>
<br> - Enrollment in any investigational vaccine study within the last 180 days or any other
<br> investigational drug study within 30 days prior to Day 1 or within 5 half-lives of the
<br> investigational compound, whichever is longer.
<br>
<br> - A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody
<br> result within 3 prior to dosing.
<br>
<br> - Positive pre-study drug/alcohol screen.
<br>
<br> - Positive HIV antibody test.
<br>
<br> - History of regular alcohol consumption within 6 months prior to the study defined as:
<br> An average weekly intake of >14 units. One unit is equivalent to 8 g of alcohol: a
<br> half pint (~240 mL) of beer, 1 glass (125 mL) of wine, or 1 (25 mL) measure of
<br> spirits.
<br>
<br> - Regular use of known drugs of abuse.
<br> | | Covid19 | Biological: sotrovimab;Other: Placebo to Biologic;Biological: sotrovimab;Other: Placebo to Biologic | Maximum observed serum concentration (Cmax) in Part 1 participants;Maximum observed serum concentration (Cmax) in Part 2 participants;Area under the serum-concentration time curve from Day 1 to Day 29 (AUCD1-29) in Part 1 participants;Area under the serum-concentration time curve from Day 1 to Day 29 (AUCD1-29) in Part 2 participants;Time to Cmax (Tmax) in Part 1 participants;Time to Cmax (Tmax) in Part 2 participants;Concentration at Day 29 (CD29) in Part 1 participants;Concentration at Day 29 (CD29) in Part 2 participants;Occurrence of adverse events (AEs) in Part 1 participants;Occurrence of adverse events (AEs) in Part 2 participants;Occurrence of clinically significant laboratory abnormalities in Part 2 participants;Occurrence of clinically significant laboratory abnormalities in Part 1 participants;Occurrence of clinically significant changes in vital signs compared to Baseline in Part 2 participants;Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) readings in Part 2 participants;Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) readings in Part 1 participants;Occurrence of adverse events of special interest (AESIs) in Part 2 participants;Occurrence of adverse events of special interest (AESIs) in Part 1 participants;Occurrence of serious adverse events (SAEs) in Part 2 participants;Occurrence of serious adverse events (SAEs) in Part 1 participants→Occurrence of clinically significant laboratory abnormalities in Part 2 participants;Occurrence of clinically significant laboratory abnormalities in Part 1 participants;Occurrence of clinically significant changes in vital signs compared to Baseline in Part 2 participants;Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) readings in Part 2 participants;Occurrence of clinically significant abnormalities on 12-lead electrocardiogram (ECG) readings in Part 1 participants;Occurrence of adverse events of special interest (AESIs) in Part 2 participants;Occurrence of adverse events of special interest (AESIs) in Part 1 participants;Occurrence of serious adverse events (SAEs) in Part 2 participants;Occurrence of serious adverse events (SAEs) in Part 1 participants;Occurrence of adverse events (AEs) in Part 2 participants;Occurrence of adverse events (AEs) in Part 1 participants;Concentration at Day 29 (CD29) in Part 2 participants;Concentration at Day 29 (CD29) in Part 1 participants;Time to Cmax (Tmax) in Part 2 participants;Time to Cmax (Tmax) in Part 1 participants;Area under the serum-concentration time curve from Day 1 to Day 29 (AUCD1-29) in Part 2 participants;Area under the serum-concentration time curve from Day 1 to Day 29 (AUCD1-29) in Part 1 participants;Maximum observed serum concentration (Cmax) in Part 2 participants;Maximum observed serum concentration (Cmax) in Part 1 participants | | | | Yes | False | | |
| NCT05019963 | 1 November 2021 | Enhancing COVID Rehabilitation With Technology | Enhancing COVID Rehabilitation With Technology (ECORT): An Open-label, Single Site Randomized Controlled Trial Evaluating the Effectiveness of Electronic Case Management for Individuals With Persistent COVID-19 Symptoms. | ECORT | University of Ottawa | 12/08/2021 | 20210812 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05019963 | Not recruiting | No | 18 Years | N/A | All | November 2021 | 152 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | | | Brooklyn Ward, HBSocSci | | broward@ohri.ca | 6137378899 | |
<br> Inclusion Criteria
<br>
<br> Participants must:
<br>
<br> 1. Be 18 years of age or older
<br>
<br> 2. Have a confirmed diagnosis of COVID-19 with a PCR test at least 12 weeks prior
<br>
<br> 3. Have at least one ongoing symptom consistent with Long COVID as measured by the WHO
<br> Post COVID Case Report Form (CRF)
<br>
<br> 4. Have a minimum WHODAS (36 item) sum score of 15
<br>
<br> 5. Be willing to use email for study activities
<br>
<br> 6. Be able and willing to use a smart phone application for the duration of the trial
<br>
<br> 7. Participants must be able to read and understand English or French.
<br>
<br> 8. Be willing and able to provide informed consent.
<br>
<br> Exclusion Criteria
<br>
<br> Participants must not:
<br>
<br> 1. Have any significant functional impairment (for example. advanced dementia, heart or
<br> lung disease) as judged by the assessing clinician
<br>
<br> 2. Participate in another long-COVID trial where treatment is required in the protocol
<br> (pharmacological or behavioural). Observational studies will be allowed.
<br>
<br> 3. Have symptoms consistent with Long COVID that are better explained by an alternative
<br> diagnosis
<br> | | Covid19 | Behavioral: NexJ Connected Wellness;Other: Usual Care | Change in WHODAS 2.0 score | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05037201 | 1 November 2021 | Text Message Nudges for COVID-19 Vaccination | A Randomized Trial of Text Message-Based Nudges to Increase COVID-19 Vaccination | | Ascension South East Michigan | 07/09/2021 | 20210907 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05037201 | Not recruiting | No | 18 Years | N/A | All | October 11, 2021 | 2000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Double (Investigator, Outcomes Assessor). | N/A | United States | | Mitesh Patel, MD, MBA | | | | Ascension |
<br> Inclusion Criteria:
<br>
<br> - Ascension Associate Employee
<br>
<br> Exclusion Criteria:
<br>
<br> - Prior vaccination for COVID-19
<br>
<br> - Exemption from COVID-19 vaccination
<br> | | Covid19 | Behavioral: Text message | Percent receiving COVID-19 Vaccine | | | | Yes | False | | |
| → | NCT05047601 | 1 November 2021 | A Post-Exposure Prophylaxis Study of PF-07321332/Ritonavir in Adult Household Contacts of an Individual With Symptomatic COVID-19 | A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 2 REGIMENS OF ORALLY ADMINISTERED PF 07321332/RITONAVIR IN PREVENTING SYMPTOMATIC SARS-COV-2 INFECTION IN ADULT HOUSEHOLD CONTACTS OF AN INDIVIDUAL WITH SYMPTOMATIC COVID-19 | | Pfizer | 01/09/2021 | 20210901 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05047601 | Recruiting | No | 18 Years | N/A | All | September 9, 2021 | 2634 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States;Brazil;Hungary;Japan;Korea, Republic of;Malaysia;Mexico;Poland;Puerto Rico;Taiwan;Thailand;Turkey;Brazil;Hungary;Japan;Korea, Republic of;Malaysia;Mexico;Poland;Puerto Rico;Taiwan;Thailand;Turkey;United States→United States;Turkey;Thailand;Taiwan;Puerto Rico;Poland;Mexico;Malaysia;Korea, Republic of;Japan;Hungary;Brazil;Turkey;Thailand;Taiwan;Puerto Rico;Poland;Mexico;Malaysia;Korea, Republic of;Japan;Hungary;Brazil;United States | ; | Pfizer CT.gov Call Center;Pfizer CT.gov Call Center | | ;ClinicalTrials.gov_Inquiries@pfizer.com | ;1-800-718-1021 | Pfizer; |
<br> Inclusion Criteria:
<br>
<br> - Participants who have a negative screening SARS-CoV-2 rapid antigen test result and
<br> who are asymptomatic household contacts with exposure within 96 hours to an individual
<br> who is symptomatic and recently tested positive for SARS CoV-2.
<br>
<br> - Fertile participants must agree to use a highly effective method of contraception
<br>
<br> Exclusion Criteria:
<br>
<br> - History of SARS-CoV-2 infection
<br>
<br> - Experiencing measured fever (documented temperature >38°C or 100.4°F) or other signs
<br> or symptoms consistent with COVID-19
<br>
<br> - Known medical history of active liver disease
<br>
<br> - Chronic Kidney Disease or have known moderate to severe renal impairment.
<br>
<br> - Known Human Immunodeficiency Virus (HIV) infection with viral load > 400 copies/ml
<br> within the last 6 months or taking prohibited medications for HIV treatment
<br>
<br> - Suspected or confirmed concurrent active systemic infection
<br>
<br> - Active cancer, other than localized skin cancer
<br>
<br> - Current or expected use of any medications or substances that are highly dependent on
<br> Cytochrome P450 3A4 (CYP3A4) for clearance or are strong inducers of CYP3A4
<br>
<br> - Has received approved, authorized, or investigational anti-SARS-CoV-2 mAb,
<br> convalescent plasma, other drugs for treatment of COVID-19, or other anti-SARS-CoV-2
<br> biologic products
<br>
<br> - Has received or is expected to receive a SARS-CoV-2 vaccine or other approved,
<br> authorized, or investigational postexposure prophylaxis treatments during the study
<br> period
<br>
<br> - Participating in another interventional clinical study with an investigational
<br> compound or device, including those for COVID-19
<br>
<br> - Known or prior participation in this trial or another trial involving PF-07321332.
<br>
<br> - Females who are pregnant or breastfeeding.
<br> | | COVID-19 | Drug: PF-07321332;Drug: Placebo for PF-07321332;Drug: Placebo for Ritonavir;Drug: Ritonavir | Proportion of participants who have a negative reverse transcription polymerase chain reaction (RT-PCR) result at baseline who develop a symptomatic, RT-PCR confirmed SARS-CoV-2 infection. | | | | Yes | False | | |
| NCT05047770 | 1 November 2021 | A Study on the Immune Response and Safety of the Shingles Vaccine and the Influenza Vaccine When Either is Given to Healthy Adults at the Same Time or Following a COVID-19 Booster Vaccine | A Phase III, Randomized, Open-label, Controlled, Multicenter Study to Evaluate the Immune Response and Safety of Both Herpes Zoster Subunit Vaccine in Healthy Adults Aged 50 Years and Older AND the Influenza Virus Vaccine in Healthy Adults Aged 18 Years and Older When Administered Sequentially or Coadministered With mRNA-1273 Booster Vaccination | | GlaxoSmithKline | 15/09/2021 | 20210915 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05047770 | Recruiting | No | 18 Years | N/A | All | October 7, 2021 | 1546 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 3 | United States | ; ; | GSK Clinical Trials;US GSK Clinical Trials Call Center;US GSK Clinical Trials Call Center | | ;GSKClinicalSupportHD@gsk.com;GSKClinicalSupportHD@gsk.com | ;877-379-3718;877-379-3718 | GlaxoSmithKline; |
<br> Inclusion Criteria:
<br>
<br> - Participants who in the opinion of the investigator, can and who will comply with the
<br> requirements of the protocol (e.g., completion of the eDiaries, return for follow-up
<br> visits).
<br>
<br> - Written informed consent obtained from the participant prior to performance of any
<br> study-specific procedure.
<br>
<br> - Age at study entry:
<br>
<br> - For HZ/su and mRNA-1273 booster cohort: A male or female aged 50 years or older
<br> at the time of randomization.
<br>
<br> - For Flu D-QIV and mRNA-1273 booster cohort: A male or female aged 18 years or
<br> older at the time of enrollment.
<br>
<br> - Healthy participants or medically stable patients as established by medical history
<br> and clinical examination at screening. A stable medical condition is defined as
<br> disease not requiring significant change in therapy or hospitalization for worsening
<br> disease during the 3 months before enrolment.
<br>
<br> - Participants who have a documented previous mRNA-1273 primary vaccination series
<br> completed (i.e., both doses) at least 6 months prior to first vaccination.
<br>
<br> - Female participants of non-childbearing potential may be enrolled in the study.
<br> Non-childbearing potential is defined as pre-menarche, current bilateral tubal
<br> ligation or occlusion, documented total hysterectomy, bilateral ovariectomy, or
<br> bilateral salpingectomy, or post-menopause.
<br>
<br> - Female participants of childbearing potential may be enrolled in the study, if the
<br> participant:
<br>
<br> - Has practiced effective contraception for 1 month prior to study intervention
<br> administration, and
<br>
<br> - Has a negative pregnancy test on the day of study intervention administration,
<br> and
<br>
<br> - Has agreed to continue effective contraception during the study until 2 months
<br> after completion of the study vaccination series.
<br>
<br> Exclusion Criteria:
<br>
<br> Medical conditions
<br>
<br> - Any clinical condition that, in the opinion of the investigator, might pose additional
<br> risk to the participant due to participation in the study or might confound post-study
<br> intervention administration safety assessments (e.g., tattoos overlying either study
<br> intervention administration site).
<br>
<br> - History of any reaction or hypersensitivity likely to be exacerbated by any component
<br> of the study interventions, including a known history of severe allergic reaction
<br> (e.g., anaphylaxis) to any component of any of the study vaccines.
<br>
<br> - Any history of Guillain-Barré syndrome.
<br>
<br> - Any history of myocarditis or pericarditis.
<br>
<br> - Acute or chronic clinically significant pulmonary, cardiovascular, hepatic or renal
<br> functional abnormality, as determined by medical history or physical examination.
<br>
<br> - Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
<br> medical history and physical examination (no laboratory testing required).
<br>
<br> - Hypersensitivity to latex.
<br>
<br> - For HZ/su and mRNA-1273 booster cohort: history of Herpes Zoster.
<br>
<br> Prior/concomitant therapy
<br>
<br> - Use of any investigational or non-registered product (drug, vaccine or medical device)
<br> other than the study intervention(s) during the period beginning 30 days before the
<br> first dose of study intervention(s) (Day -29 to Day 1), or their planned use during
<br> the study period.
<br>
<br> - Planned administration/administration of a vaccine not foreseen by the study protocol
<br> in the period starting 30 days before first dose and ending 30 days after the last
<br> dose of study intervention administration. However, for HZ/su and mRNA-1273 booster
<br> cohort: licensed pneumococcal vaccines and non-replicating vaccines (i.e., inactivated
<br> and subunit vaccines, including inactivated and subunit influenza vaccines, with or
<br> without adjuvant for seasonal or pandemic flu) may be administered up until 8 days
<br> prior to dose 1 of HZ/su and/or dose 2 of HZ/su and/or at least 14 days after any dose
<br> of HZ/su. For Flu D-QIV and mRNA-1273 booster cohort: licensed pneumococcal vaccines
<br> and non-replicating vaccines (i.e., inactivated and subunit vaccines, other than
<br> influenza vaccines) may be administered up until 8 days prior to dose 1 of Flu D-QIV
<br> and/or at least 30 days after any dose of Flu D-QIV. For time interval between other
<br> routine vaccines with mRNA-1273 booster dose (administered in the study), local
<br> guidelines must be followed.
<br>
<br> In case emergency mass vaccination for an unforeseen public health threat (e.g., a
<br> pandemic) is organized by public health authorities outside the routine immunization
<br> program, the time period described above can be reduced if necessary for that mass
<br> vaccination vaccine, provided this vaccine is licensed and used according to its Product
<br> Information.
<br>
<br> - Administration of long-acting immune-modifying drugs at any time during the study
<br> period (e.g., infliximab).
<br>
<br> - Administration of immunoglobulins and/or any blood products or plasma derivatives
<br> during the period starting 3 months before the first dose of study intervention(s) up
<br> to 1 month post last dose or planned administration during the study period.
<br>
<br> - Prior planned or chronic administration (defined as more than 14 days in total) of
<br> immunosuppressants or other immune-modifying drugs during the period starting 3 months
<br> prior to the first vaccine. For corticosteroids, this will mean more than 14 days in
<br> total of prednisone =20 mg/day or equivalent is not allowed. Inhaled, intra-articular
<br> and topical steroids are allowed.
<br>
<br> - For HZ/su and mRNA-1273 booster cohort: Previous vaccination against Herpes Zoster
<br> with the exception of receipt of live attenuated HZ vaccine.
<br>
<br> - For Flu D-QIV and mRNA-1273 booster cohort: Administration of a seasonal influenza
<br> vaccine during the 6 months preceding entry into the study.
<br>
<br> - Prior administration of an investigational or licensed coronavirus (SARS-CoV,
<br> MERS-CoV, SARS-CoV-2) vaccine except for mRNA-1273 vaccine.
<br>
<br> - Any contraindication to the study intervention(s).
<br>
<br> Prior/concurrent clinical study experience
<br>
<br> • Planning to or concurrently participating in another clinical study (including current /
<br> planned simultaneous participation in another interventional study to prevent or treat
<br> COVID-19), at any time during the study period, in which the participant has been or will
<br> be exposed to an investigational or a non-investigational vaccine / product (drug or
<br> medical device).
<br>
<br> Other exclusions
<br>
<br> - Pregnant or lactating female.
<br>
<br> - Female planning to become pregnant or planning to discontinue contraceptive
<br> precautions wit | | Herpes Zoster | Biological: HZ/su;Combination Product: Flu D-QIV;Biological: mRNA-1273 | Anti-glycoprotein E (gE) antibody concentrations expressed as Geometric Mean Concentrations (GMCs) in HZ/suSeq and HZ/suCoAd groups, and between-group ratios;Anti-S protein antibody concentrations expressed as GMCs in HZ/suSeq and HZ/suCoAd groups, and between-group ratios;Anti-hemagglutinin inhibition (HI) antibody titers expressed as Geometric Mean Titers (GMTs) against the 4 influenza strains in Flu D-QIV vaccine in FluD-QIVSeq and FluD-QIVCoAd groups, and between-group ratios;Anti-S protein antibody concentrations expressed as GMCs in FluD-QIVSeq and FluD-QIVCoAd groups, and between-group ratios | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05092542 | 1 November 2021 | Multilevel Community-Based Mental Health Intervention to Address Structural Inequities and Adverse Disparate Consequences of COVID-19 Pandemic on Latinx Immigrant and African Refugees | Multilevel Community-Based Mental Health Intervention to Address Structural Inequities and Adverse Disparate Consequences of COVID-19 Pandemic on Latinx Immigrant and African Refugees | RIWP+ | University of New Mexico | 22/10/2021 | 20211022 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05092542 | Recruiting | No | 18 Years | N/A | All | October 18, 2021 | 1300 | Interventional | Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 3 | United States | ; | Jessica Goodkind, PhD;Timothy Wester | | jgoodkin@unm.edu;osp@unm.edu | 505-280-4391;505-277-4186 | |
<br> Inclusion Criteria:
<br>
<br> - All Latinx immigrants and African refugees aged 18 and older residing in New Mexico
<br> will be eligible to participate.
<br>
<br> Exclusion Criteria:
<br>
<br> - For the random sample of 1000 Latinx immigrants, exclusion criteria will be having
<br> used the services of one of the four community-based partner organizations serving
<br> Latinx immigrants within the past year (at time of study enrollment). For the 240
<br> Latinx immigrants and 60 African refugees recruited through the five community-based
<br> organizations, exclusion criteria will be severe cognitive functioning problems or
<br> mental illness that is so severe as to impede participation in a group and that
<br> warrants immediate individual treatment.
<br> | | Mental Health Issue;Mental Health Disorder;Stress, Emotional;Economic Problems | Behavioral: Refugee and Immigrant Well-being Project (RIWP) | Psychological Distress;Psychological Distress;Psychological Distress;Physical Health;Daily Stressors;Economic Precarity | | | | Yes | False | | |
| --- | NCT05092568 | 1 November 2021 | Comparison of General Characteristics of Patients Diagnosed of Pcr Positive Covid 19 Followed In Service | Comparison of General Characteristics of Patients Diagnosed of Pcr Positive Covid 19 Followed In Service | SarsCoV2 | Saglik Bilimleri Universitesi | 22/10/2021 | 20211022 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05092568 | Recruiting | No | N/A | N/A | Female | October 1, 2021 | 45 | Observational [Patient Registry] | | | Turkey | ; ; | Ozge Ozdemir;Ozge MD Ozdemir, MD;özge Ö özdemir, MD | | ;drozgeozde@gmail.com;drozgeozde@gmail.com | ;9005326384089;05326384089 | Saglik Bilimleri Universitesi; |
<br> Inclusion Criteria: Pregnant patients positive PCR Covid test results followed up and
<br> treated in the pandemic service of Basaksehir Çam and Sakura City Hospital.
<br>
<br> Exclusion Criteria: no exclusion criteria
<br>
<br> -
<br> | | COVID-19;Vaccinia | | vaccine;pregnancy results | | | | Yes | False | | |
| NCT05092581 | 1 November 2021 | COVID-19 Study of Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19 | A Phase 1b, Open-Label, Single Dose Study Assessing the Pharmacokinetics, Safety, Tolerability, and Efficacy of Intravenous Anti-Spike(s) SARS-CoV-2 Monoclonal Antibodies (Casirivimab+Imdevimab) for the Treatment of Pediatric Patients Hospitalized Due to COVID-19 | | Regeneron Pharmaceuticals | 22/10/2021 | 20211022 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05092581 | Not recruiting | No | N/A | 17 Years | All | December 20, 2021 | 40 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | | ; | Clinical Trial Management;Clinical Trials Administrator | | ;clinicaltrials@regeneron.com | ;844-734-6643 | Regeneron Pharmaceuticals; |
<br> Key Inclusion Criteria:
<br>
<br> 1. Has SARS-CoV-2 positive antigen or molecular diagnostic test =72 hours prior to study
<br> enrollment Note: historical record of positive result is acceptable as long as the
<br> sample was collected =72 hours prior to enrollment
<br>
<br> 2. Has symptoms consistent with COVID-19, as determined by the investigator, with onset =
<br> 14 days before dosing
<br>
<br> 3. Hospitalized due to COVID-19
<br>
<br> 4. Provide informed consent signed by study patient or legally acceptable
<br> representative/guardian
<br>
<br> Key Exclusion Criteria:
<br>
<br> 1. In the opinion of the investigator, unlikely to survive for >96 hours from screening
<br>
<br> 2. Neonates having gestational age of <29 weeks and weight <1.1 kg
<br>
<br> 3. Receiving extracorporeal membrane oxygenation (ECMO)
<br>
<br> 4. Has new-onset stroke or seizure disorder during hospitalization
<br>
<br> 5. Initiated on renal replacement therapy due to COVID-19
<br>
<br> 6. Has circulatory shock requiring vasopressors on dosing day Note: Patients who require
<br> vasopressors for sedation-related hypotension or reasons other than circulatory shock
<br> may be eligible in this study
<br>
<br> 7. Participation in a clinical research study, including any double-blind study,
<br> evaluating an investigational product within 30 days and less than 5 half-lives of the
<br> investigational product prior to the screening visit
<br>
<br> 8. Members of the clinical site study team and/or their immediate family
<br>
<br> 9. Plans to receive an investigational or approved SARS-CoV-2 vaccine within 90 days
<br> after study drug administration based on current Centers for Disease Control
<br> vaccination guidelines (CDC, 2021). Refer to the latest CDC guidance for any updates.
<br>
<br> Note: Patients who have already completed vaccination prior to study enrollment may be
<br> allowed in the study.
<br>
<br> 10. Prior use (within 90 days prior to study drug administration) or current use of any
<br> investigational, authorized, or approved passive antibody for prophylaxis of
<br> SARS-CoV-2 infection, including convalescent plasma, convalescent sera, hyperimmune
<br> globulin, or other monoclonal antibodies (eg, bamlanivimab and etesevimab, sotrovimab)
<br>
<br> Note: Other protocol defined Inclusion/ Exclusion criteria apply
<br> | | COVID-19 | Drug: casirivimab+imdevimab | Concentrations of casirivimab+imdevimab in serum over time;Proportion of patients with treatment-emergent serious adverse events (SAEs);Proportion of patients with infusion-related reactions;Proportion of patients with hypersensitivity reactions | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05092607 | 1 November 2021 | Evaluation of the Detection Performance of the N Antigenemia of SARS-CoV-2 in the General Population for the Diagnosis and Screening of COVID-19 | Evaluation of the Detection Performance of the N Antigenemia of SARS-CoV-2 in the General Population for the Diagnosis and Screening of COVID-19 | CoviBlood | Assistance Publique - Hôpitaux de Paris | 01/10/2021 | 20211001 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05092607 | Recruiting | No | 18 Years | N/A | All | July 15, 2021 | 1467 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). | N/A | France | ; ; | VISSEAUX BENOIT;VISSEAUX BENOIT;Choquet Christophe | | ;benoit.visseaux@aphp.fr;christophe.choquet@aphp.fr | ;01 40 25 61 52;01 40 25 60 12 | Assistance Publique - Hôpitaux de Paris; |
<br> Inclusion Criteria:
<br>
<br> - Subject informed and having signed the consent
<br>
<br> - Age = 18 years old
<br>
<br> - Affiliation to a social security
<br>
<br> - Indication for carrying out a screening or diagnostic test for COVID-19
<br>
<br> For the study of diagnostic performance in symptomatic hospitalized patients, at least one
<br> of the following criteria (HAS recommendations - June 2020):
<br>
<br> - Respiratory rate> 25 / min
<br>
<br> - Pulse> 100 / mn
<br>
<br> - SpO2 <94%
<br>
<br> - Dyspnea
<br>
<br> - Presence of HCSP comorbidities
<br>
<br> - Unfavorable psycho-family environment
<br>
<br> For the study of diagnostic performance in asymptomatic patients:
<br>
<br> ? No symptoms of respiratory infection present (fever, chills, sweating, headache, myalgia,
<br> feeling sick, cough, rhinorrhea or sputum, sore throat, chest pain)
<br>
<br> For the study of diagnostic performance in symptomatic or pauci-symptomatic patients who
<br> are not hospitalized:
<br>
<br> ? None of the criteria of the two previous populations
<br>
<br> Exclusion Criteria:
<br>
<br> - Contraindication to performing a nasopharyngeal sample or inability to perform the
<br> nasopharyngeal sample
<br>
<br> - Subject who has already participated in the study
<br>
<br> - All categories of persons protected according to the CSP (minor subject, pregnant,
<br> deprived of liberty, under measure of legal protection, guardianship or curators)
<br>
<br> - Lack of social security affiliation, CMU (or equivalent)
<br>
<br> - Subject under AME
<br>
<br> - Lack of signed informed consent
<br>
<br> For the study of diagnostic performance in pauci-symptomatic patients
<br>
<br> • Need for nasal oxygen therapy
<br>
<br> For the study of diagnostic performance in asymptomatic patients
<br>
<br> - Presence of respiratory symptoms suggestive of viral infection of the upper
<br> respiratory tract
<br>
<br> - Need for nasal oxygen therapy
<br> | | Respiratory Viral Infection | Diagnostic Test: Venous and Capillary blood sampling | evaluation of the sensitivity of detection of SARS-CoV-2 N antigen | | | | Yes | False | | |
| → | NCT05092711 | 1 November 2021 | Cardiovascular Risk Factors , Complications and Threputic Management Strategies in Patients With Coronary Heart Disease and COVID 19 | Cardiovascular Risk Factors , Complications and Threputic Management Strategies in Patients With Coronary Heart Disease and COVID 19 | | Assiut University | 22/10/2021 | 20211022 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05092711 | Not recruiting | No | 18 Years | 80 Years | All | November 2021 | 150 | Observational | | | Egypt | ; ; | Mohamed AboelKasem farghal, Professor;Hossam Hassan Ali Elaraby, Professor;Ahmed Marghany Hassan, Resident | | ;;ghnofer@Gmail.com | ;;01285006001 | Assiut University;Assiut University; |
<br> Inclusion Criteria:
<br>
<br> 150 consecutive patients, men or women [=18 years and <80 years at the time of
<br> identification]
<br>
<br> - Patient s may fulfil more than one of the following diagnostic criteria:
<br>
<br> - Elective CABG.
<br>
<br> - Elective PCI.
<br>
<br> - Acute coronary syndromes (acute myocardial infarction with ST elevation (STEMI) and
<br> Non ST elevation MI (Non-STEMI) including those treated with primary PCI and/or CABG,
<br> and unstable angina).
<br>
<br> It is recognised that hospital diagnoses for AMI, and unstable angina without evidence of
<br> infarction, may not always meet the World Heart Organisation (WHO) or other standard
<br> diagnostic criteria. However, it is important to include all cases diagnosed as AMI or
<br> unstable angina in hospital clinical practice because, as a consequence of these diagnoses,
<br> they should all have received appropriate management for secondary prevention.
<br> | | Whether the Guidelines on Cardiovascular Disease Prevention Are Being Followed or Not | Behavioral: Observation;Drug: Observation | • To determine in patients with established CHD (acute myocardial infarction and ischaemia and patients following revascularisation by angioplasty or coronary artery surgery) whether the guidelines on cardiovascular disease prevention are being followed.;• To follow-up all patients one year after the interview for hospitalisations, cardiovascular procedures, cardiovascular events and cardiovascular and all cause mortality;• To describe the prevalence of cardiovascular risk factors, acute and long-term cardiovascular complications and therapeutic management in patients with CHD and COVID-19;• To compare the risk factor profiles in CHD patients with and without a history of COVID-19;• To compare the diagnostic and therapeutic strategies in CHD patients with and without a history of COVID-19;• To compare the acute and long-term cardiovascular complications in CHD patients with and without a history of COVID-19→• To compare the acute and long-term cardiovascular complications in CHD patients with and without a history of COVID-19;• To compare the diagnostic and therapeutic strategies in CHD patients with and without a history of COVID-19;• To compare the risk factor profiles in CHD patients with and without a history of COVID-19;• To describe the prevalence of cardiovascular risk factors, acute and long-term cardiovascular complications and therapeutic management in patients with CHD and COVID-19;• To follow-up all patients one year after the interview for hospitalisations, cardiovascular procedures, cardiovascular events and cardiovascular and all cause mortality;• To determine in patients with established CHD (acute myocardial infarction and ischaemia and patients following revascularisation by angioplasty or coronary artery surgery) whether the guidelines on cardiovascular disease prevention are being followed. | | | | Yes | False | | |
| NCT05092724 | 1 November 2021 | Is Fetal Hemoglobin a Key for Improvement of Hypoxia and Saving Last Breath in COVID-19 Patient?. A Pilot Study. | Is Fetal Hemoglobin a Key for Improvement of Hypoxia and Saving Last Breath in COVID-19 Patient?. A Pilot Study. | | Zagazig University | 19/10/2021 | 20211019 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05092724 | Not recruiting | No | 18 Years | 80 Years | All | October 20, 2021 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator). | N/A | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Admitted covid 19 patients to the ICU with the following criteria : :
<br>
<br> - Hypoxia (P/F less than 100)
<br>
<br> - Need for high level of oxygenation or ventilatory support
<br>
<br> - Tachypnea, respiratory distress due to hypoxia
<br>
<br> - >50 percent involvement of the lung parenchyma on chest imaging .
<br>
<br> - Serum IL-6 = 5 x upper normal limit of daily increase of >1 time
<br>
<br> - Ferritin >300 ug/L with doubling within 24 hours
<br>
<br> - Ferritin >600 ug/L at presentation
<br>
<br> - LDH >250 U/L
<br>
<br> - Elevated D-dimer (>1 mg/L)
<br>
<br> Exclusion Criteria:
<br>
<br> - 1- Patients with hemodynamic instability or multiorgan failure 2- Failure to obtain
<br> temporary vascular access under ultrasound guidance or due to bleeding tendency.
<br> | | COVID-19 Acute Respiratory Distress Syndrome | Procedure: fetal blood transfusion | • To evaluate the effect of increasing fetal hemoglobin protocol on the outcome in patients with fulminant COVID-19 | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| NCT05094739 | 1 November 2021 | Knowledge and Attitude of a Group of Egyptian Parents Toward Dental Treatment of Their Children During the Fourth Wave of COVID-19: A Cross Sectional Study. | Knowledge and Attitude of a Group of Egyptian Parents Toward Dental Treatment of Their Children During the Fourth Wave of COVID-19: A Cross Sectional Study. | | Cairo University | 23/10/2021 | 20211023 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05094739 | Not recruiting | No | 20 Years | 70 Years | All | December 2021 | 350 | Observational | | | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Parents with at least intermediate education.
<br>
<br> Exclusion Criteria:
<br>
<br> - Illiterate parents.
<br>
<br> - Refusal of participation
<br> | | COVID-19 Pandemic | | Knowledge and attitude of a group of Egyptian parents toward dental treatment of their children during the fourth wave of COVID-19 pandemic. | | | | Yes | False | | |
| → | NCT05097053 | 1 November 2021 | A Heterologous 3rd Boost of MVC-COV1901 to Evaluate Immunogenicity and Safety in Adults With 2 Doses of ChAdOx1-nCov-19 | A Parallel Group, Prospective, Randomized, Two-arm, Open-label Study to Evaluate the Immunogenicity, Safety, and Tolerability of Heterologous 3rd Boost of MVC-COV1901 in Adults With 2 Doses of ChAdOx1-nCov-19 in 3 Months and 6 Months | | Taoyuan General Hospital | 17/10/2021 | 20211017 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05097053 | Recruiting | No | 20 Years | 64 Years | All | October 7, 2021 | 200 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 4 | Taiwan | ; ; | Chieh-Yu Cheng, MD.PhD.;Chieh-Yu Cheng, MD.PhD.;Chieh-Yu Cheng, M.D., Ph.D. | | ;s841060@gm.ym.edu.tw;s841060@gm.ym.edu.tw | ;+886-3-3699721;+886-3-3699721 | Taoyuan General Hospital; |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female participant aged 20 to 64 years at randomization.
<br>
<br> 2. Has received two doses of the ChAdOx1-nCov-19 (Astra-Zeneca) 12 to 16 weeks before
<br> randomization.
<br>
<br> 3. Female participant must:
<br>
<br> 1. Be either of non-childbearing potential, i.e. surgically sterilized (defined as
<br> having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral
<br> salpingectomy; tubal ligation alone is not considered sufficient) or one year
<br> post-menopausal;
<br>
<br> 2. Or, if of childbearing potential, be abstinent or agree to use medically
<br> effective contraception from 14 days before screening to 30 days following the
<br> last administration of study intervention. Acceptable forms include:
<br>
<br> i.Implanted hormonal methods of contraception or placement of an intrauterine device
<br> or intrauterine system ii.Established use of hormonal methods (injectable, pill, patch
<br> or ring) combined with barrier methods of contraception: condom or occlusive cap
<br> (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
<br> c.Have a negative pregnancy test
<br>
<br> 4. Participant is willing and able to comply with all required study visits and follow-up
<br> required by this protocol.
<br>
<br> 5. Participant or the participant's legal representative must understand the procedures
<br> of the study and provide written informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnant or breast feeding or have plan to become pregnant within 30 days after the
<br> last administration of study intervention.
<br>
<br> 2. Currently receiving or received any investigational intervention within 30 days prior
<br> to the first dose of study intervention.
<br>
<br> 3. Administered any licensed live-attenuated vaccines within 28 days or other licensed
<br> non-live-attenuated vaccines within 7 days prior to the first dose of study
<br> intervention.
<br>
<br> 4. Administered any blood product or intravenous immunoglobulin administration within 12
<br> weeks prior to the first dose of study intervention.
<br>
<br> 5. Currently receiving or anticipate to receive concomitant immunosuppressive or
<br> immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing
<br> corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone
<br> less than 20 mg or equivalent) within 12 weeks prior to the first dose of study
<br> intervention.
<br>
<br> 6. Currently receiving or anticipate to receive treatment with tumor necrosis factor
<br> (TNF)-a inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to
<br> the first dose of study intervention.
<br>
<br> 7. Major surgery or any radiation therapy within 12 weeks prior to the first dose of
<br> study intervention.
<br>
<br> 8. Has received any other investigational or licensed COVID-19 vaccine.
<br>
<br> 9. Immunosuppressive illness or immunodeficient state, including hematologic malignancy,
<br> history of solid organ, bone marrow transplantation, or asplenia.
<br>
<br> 10. A history of malignancy with potential risk for recurrence after curative treatment,
<br> or current diagnosis of or treatment for cancer (exceptions are squamous and basal
<br> cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the
<br> discretion of the investigator).
<br>
<br> 11. Bleeding disorder considered a contraindication to IM injection or phlebotomy.
<br>
<br> 12. Known SARS-CoV-2 infection in the recent 3 months prior to the first dose of study
<br> intervention.
<br>
<br> 13. A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or
<br> antiphospholipid syndrome.
<br>
<br> 14. Participant who, in the investigator's judgement, is not in a stable condition and by
<br> participating in the study could adversely affect the safety of the participant,
<br> interfere with adherence to study requirements or evaluation of any study endpoint.
<br> This may include a participant with ongoing acute diseases, severe infections,
<br> autoimmune disease, laboratory abnormality or serious medical conditions in the
<br> following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal,
<br> or psychiatric.
<br>
<br> 15. A history of hypersensitivity to any vaccine or a history of allergic disease or
<br> reactions likely to be exacerbated by any component of the MVC-COV1901.
<br>
<br> 16. Body (oral, rectal, or ear) temperature = 38.0°C or acute illness (not including minor
<br> illnesses such as diarrhea or mild upper respiratory tract infection at the discretion
<br> of the investigator) within 2 days before the first dose of study intervention.
<br> | | COVID-19 Vaccine | Biological: MVC-COV1901(3 Months);Biological: MVC-COV1901(6 Months) | Primary Immunogenicity;Primary Safety→Primary Safety;Primary Immunogenicity | | | | Yes | False | | |
| NCT05099497 | 1 November 2021 | Supporting Audit and Feedback to Encourage Vaccine Uptake | Big Data and Little Behaviours: Feedback and Quality Improvement Supports to Primary Care to Facilitate COVID Vaccine Uptake | | Women's College Hospital | 05/10/2021 | 20211005 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05099497 | Not recruiting | No | N/A | N/A | All | September 21, 2021 | 600 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Single (Investigator). | N/A | Canada | | Noah Ivers, MD | | | | Women's College Hospital |
<br> Inclusion Criteria:
<br>
<br> - 6,690 family physicians across Ontario who have active (up-to-date passwords) ONE ID
<br> accounts
<br>
<br> Exclusion Criteria:
<br>
<br> - family physicians across Ontario who do not have an active ONE ID account
<br>
<br> - family physicians with less than 300 rostered patients
<br>
<br> - family physicians with more than 3000 rostered patients
<br> | | Covid19 Vaccination;Vaccine Uptake | Other: Using Practice Facilitators to Support Physicians | Proportion of patients age 12+ not yet vaccinated | | | | Yes | False | | |
| → | ACTRN12620000448943 | 1 November 2021 | Expressive Writing To Combat Distress Associated With The COVID-19 Pandemic In People With Inflammatory Bowel Disease | Expressive Writing To Combat Distress Associated With The COVID-19 Pandemic In People With Inflammatory Bowel Disease | | Deakin University | 06/04/2020 | 20200406 | ANZCTR | https://anzctr.org.au/ACTRN12620000448943.aspx | Not Recruiting | No | 18 Years | No limit | Both males and females | 20/06/2020 | 154 | Interventional | Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy; | Not Applicable | Australia;New Zealand;Singapore;United Kingdom;United States of America;Canada;South Africa→South Africa;Canada;United States of America;United Kingdom;Singapore;New Zealand;Australia | | | | | | | Inclusion criteria: Diagnosis of IBD: Crohn’s disease, ulcerative colitis or indeterminate colitis established using standard criteria (we will ask for the details of patient's gastroenterologist, and these will be verified by our team);
<br>Distress: at least mild distress on K10 (scores 20-29);
<br>Age: 18 years and older;
<br>Other: able to read and write in English, with access to internet/telephone to participate in online/telephone intervention and available to participate for approx. 30 minutes for 4 consecutive days (likely in the evening). | Exclusion criteria: Severe distress based on K10 (scores 30-50 very high distress) as these participants would require a more intensive therapeutic approach. | inflammatory bowel disease;Crohn's disease;ulcerative colitis;indeterminate colitis;COVID-19; <br>inflammatory bowel disease <br>Crohn's disease <br>ulcerative colitis <br>indeterminate colitis <br>COVID-19;Oral and Gastrointestinal - Inflammatory bowel disease;Oral and Gastrointestinal - Crohn's disease;Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon;Mental Health - Anxiety;Mental Health - Depression;Infection - Other infectious diseases | Expressive/gratitude writing intervention – This group will participate in the adapted evidenced-based 4-day writing program (Pennebaker 1997). Participants will meet with the facilitator (a researcher with a Psychology degree) using Zoom / over the phone or will access a recording of the intervention (if the time difference makes a Zoom/phone session impractical) in a group format four times in one week for approx. 30 minutes (25 minutes of writing time). Daily e-mail reminders will be sent during the 4 days of writing. Session structure – 1 min to complete the distress VAS measure (before), 5 minutes write any reflection from last session, 15 minutes spent writing about your thoughts and feelings, 5 minutes writing about the things you are grateful for, 1 min to complete the distress VAS measure (after). The instruction each day will be (adapted from Pennebaker):<br>“Please write about your thoughts and feelings about your IBD and the recent situation with COVID-19. Try to select something that you had a strong reaction to – perhaps this was a thought that was challenging or unpleasant. Feel free to really let go and explore your very deepest emotions and thoughts. You might tie your topic to your relationships with others, including parents, lovers, friends or relatives, to your past, your present, your future, or to who you have been, who you would like to be, or who you are now. All of your writing will be completely confidential. Please don’t worry about spelling, sentence structure, or grammar. Feel free to type or write by hand.”<br>Participants will not be asked to share their writing with the study investigators, to ensure free expression. | Distress measured on Kessler Psychological Distress Scale (K10)[Baseline, post-intervention (within one week since the completion of the intervention, primary endpoint), 3 months post-intervention] | 22/10/2021 | 08/09/2021 | | Yes | False | | |
| ACTRN12620001029987 | 1 November 2021 | Negative predictive value of the FebriDx host response point-of-care test in patients presenting to a single Australian Emergency Department with suspected COVID-19. | Negative predictive value of the FebriDx host response point-of-care test in patients presenting to a single Australian Emergency Department with suspected COVID-19. | | Planet Innovation | 09/10/2020 | 20201009 | ANZCTR | https://anzctr.org.au/ACTRN12620001029987.aspx | Recruiting | No | 2 Years | No limit | Both males and females | 08/10/2021 | 300 | Observational | Purpose: Screening;Duration: Cross-sectional;Selection: Defined population;Timing: Both; | Not Applicable | Australia | | | | | | | Inclusion criteria: Participant inclusion criteria
<br>
<br>Adult and paediatric patients (aged 2 and over) who meet the current Eastern Health case definition for COVID-S PCR testing at their time of ED presentation will be eligible for inclusion
<br>Able to read an English language PICF and provide in person informed consent or consent for a minor for whom they are responsible for.
<br>
<br> | Exclusion criteria: Participant exclusion criteria
<br>
<br>- Patients having COVID-S screening testing who do not meet the Eastern Health case definition at the time of testing (eg. asymptomatic pre-operative screening, asymptomatic patients awaiting private hospital transfer).
<br>- Patients who are critically unwell, where the treating clinician feels that testing might interfere with their immediate clinical care.
<br>- Patients who meet any of the following FebriDx device registration exclusion criteria:
<br>- <2 years of age
<br>- acute respiratory symptom onset >14 days prior to testing
<br>- current Immunosuppressive or interferon therapy
<br>- live immunisation within the last 30 days
<br>- fever lasting >7 days
<br>- antibiotic or antiviral use in the preceding 14 days
<br>- Experienced major trauma, major surgical intervention, or severe burns within the last 30 days.
<br> | Acute Respiratory Infections;Infection;COVID-19; <br>Acute Respiratory Infections <br>Infection <br>COVID-19;Respiratory - Other respiratory disorders / diseases;Infection - Other infectious diseases | This real-world observational diagnostic accuracy study will compare the FebriDx point of care test result to that of the COVID-19 RT-PCR reference standard with a view to determining whether FebriDx has a sufficient negative predictive value to screen suspected COVID-19 patients attending the hospital emergency department. Patients who meet the Eastern Health case definition for suspected COVID-19 infection (COVID-S) PCR testing will be invited to have same time point of care testing with the FebriDx device. <br><br>Patients who consent to participate in the trial will undergo a FebriDx finger prick test. A 5µl capillary blood sample will be taking via a built in lancet and collected into the blood collection tube which is then moved into position on the lateral flow assay component of test. This test will be performed by a healthcare professional e.g. Nurse or Doctor in the Emergency Department.<br><br>Their treating clinician will be blinded to the result, which will be directly viewed and documented by a member of the research team who is not directly involved in the patient’s clinical care. Neither the participant or the treating doctor will have access to the FebriDx result. We have done this because it is important that the result is not used as part of the management decision while we are still working out how accurate it is. A member of the research team, most likely a research nurse, will be performing the test in one of the dedicated testing areas within the department and not at the patient bedside.<br><br>All parameters will be observed retrospectively by the study team from review of electronic medical records. They key parameters being observed in patients are:<br>- the COVID-19 PCR result<br>- the FebriDx result<br>- presenting symptoms<br>- ED observat | To determine the negative predictive value of FebriDx for patients presenting to an Australian Emergency Department (ED) who fit the Department of Health case definition for suspected COVID-19 (COVID-S) infection.<br><br>The FebriDx results will be compared to the COVID-19 RT-PCR based reference standard. Note: Treating physicians will be blinded to the FebriDx result - this is a biospecimen analysis study.[Each patient that participates in the study will have samples collected for both the COVID RT-PCR reference standard (oropharyngeal/(bilateral) nasal or nasopharyngeal swabs) and FebriDx (µl fingerstick blood sample),<br><br>The FebriDx results will be available within 10 minutes and can be interpreted for up to one hour. The FebriDx result will be directly viewed and documented by a member of the research team who is not directly involved in the patient's clinical care. The treating physician will be blinded to the FebriDx result.<br><br>At the study completion the FebriDx result will be compared to the PCR based reference standard to calculate the negative predictive value for the population in question.] | | | | Yes | False | | |
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| ACTRN12621001465842 | 1 November 2021 | The effect of sirolimus-based immunosuppression and dietary fibre supplementation on booster COVID-19 vaccine responses in kidney transplant recipients - Part 2: inulin dietary fibre supplementation | Rapamycin and Inulin for booster VAccine response STIMulation (RIVASTIM) - Part 2: The effect of inulin dietary fibre supplementation on booster COVID-19 vaccine responses in kidney transplant recipients | | Professor P. Toby H Coates (MBBS FRACP PhD) | 26/10/2021 | 20211026 | ANZCTR | https://anzctr.org.au/ACTRN12621001465842.aspx | Not Recruiting | No | 18 Years | 80 Years | Both males and females | 01/11/2021 | 120 | Interventional | Purpose: Treatment; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Safety/efficacy; | Not Applicable | Australia | | | | | | | Inclusion criteria: Kidney transplant recipients
<br>Aged 18-80 years
<br>Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based) and have demonstrably not responded (undetectable anti-spike protein antibodies) or low response (anti-RBD antibody titre < 100 U/mL)
<br> | Exclusion criteria: Aged <18 years or >80 years
<br>Multi-organ transplant recipients (e.g. kidney-pancreas)
<br>Patients who are currently pregnant
<br>Patient has an underlying condition predisposing to increased gut permeability (including, but not limited to: active or recent within 6 weeks gastrointestinal infection, inflammatory bowel disease, short-gut syndrome, or coeliac disease)
<br>Have not received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based)
<br>Have received 2 doses of a COVID-19 vaccine regimen (either adenoviral vector or mRNA-based) and have mounted an adequate immune response (anti-spike protein antibodies above detection threshold) | COVID-19;Drug-induced immunosuppression;Vaccine non-response; <br>COVID-19 <br>Drug-induced immunosuppression <br>Vaccine non-response;Infection - Other infectious diseases;Inflammatory and Immune System - Other inflammatory or immune system disorders;Inflammatory and Immune System - Normal development and function of the immune system;Respiratory - Other respiratory disorders / diseases | Kidney transplant patients who are non- or low-responders to conventional 2-dose COVID-19 vaccination regimen will be randomised to receive 20g inulin daily, divided into 2 doses of 10g dissolved in 200mL water. For a week patients will take 10g daily in a single dose, uptitrating to 20g daily in 2 divided doses thereafter until the conclusion of the trial (8-10 weeks total therapy). Adherence will be monitored through return and weighing of unused supplement powder at conclusion of the trial. 4 weeks after randomisation patients will receive a 3rd COVID-19 mRNA vaccine (Pfizer Comirnaty) dose. All participants will receive COVID vaccination during a clinical trial visit to ensure adherence. | Absolute proportion of patients in each arm meeting the threshold of 20.2% neutralising antibody required for clinical protection from SARS-CoV2 infection. Neutralising antibody titres will be assessed by dilution at which paCoV-2 live virus entry into angiotensin converting enzyme (ACE) 2 receptor positive cells by 50%.[4-6 weeks post-vaccination. During the intervening post-vaccination period patients will be clinically assessed once by phone 1 week post vaccination. ] | | | | Yes | False | | |
| → | ISRCTN53375662 | 1 November 2021 | The health burden of COVID-19 and healthcare resource utilization in England | An observational retrospective cohort study describing clinical outcomes and utilization of healthcare resources among persons with COVID-19 in England, stratified by infection severity and selected comorbidities | | AstraZeneca (United Kingdom) | 21/10/2021 | 20211021 | ISRCTN | https://www.isrctn.com/ISRCTN53375662 | Recruiting | No | | | Both | 01/09/2021 | 22000000 | Observational | Observational retrospective cohort study (Other) | Not Applicable | United Kingdom;England→England;United Kingdom | | | | | | | Inclusion criteria: This study will include all subjects in England who were active in all datasets described above for at least 1 day during the COVID-19 infection identification period | Exclusion criteria: Subjects will be excluded from this study if they have less than 12 months of baseline data prior to 1 September 2020 | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> This study will use a series of de-identified patient datasets in England, accessible through National Health Services (NHS) Digital.<br> The study period will start on 1 September 2017 and end on the time of data extraction (i.e., the latest day of data overlap across required datasets). The period that will be used to identify COVID-19 infections will start on 1 September 2020 and end 12 weeks prior to the end of the study period. Patient baseline characteristics will be assessed up to a 36-month period immediately before 1 September 2020 (i.e., 1 September 2017 – 31 August 2020). A 36-month period is applied to allow sufficient time for identifying chronic conditions - including the ability to use that information to define risk profiles in otherwise healthy individuals. The pre-vaccination period will be defined as beginning on 1 September 2020 and ending on 21 December 2020. The pre-vaccination period will end on 7 December 2020. The vaccination period will be defined as beginning on 8 December 2020 and ending on the last day of the study period.<br> | <br> 1. Size of populations (pre-defined) in England who potentially are ineligible for vaccine or are at risk of COVID-19 infection following vaccination. This will be measure using count (N) of those at risk and the proportion (%) at risk over the baseline period.<br> 2. Incidence of COVID-19, by age group, disease severity, and selected comorbidities during the pre-vaccination and vaccination periods of the study (1 September 2020-end of study period). Incidence will be measured in infections per 100 person months with 95% confidence intervals.<br> 3. Incidence of long COVID-19 syndrome, by age, disease severity, and selected comorbidities during the pre-vaccination and vaccination periods of the study (1 September 2020-end of study period). Incidence will be measured in infections per 100 person months with 95% confidence intervals.<br> 4. Patterns of HCRU and cost associated with an episode of COVID-19, stratified by age, selected comorbidities, disease severity and the occurrence (vs absence) of long COVID-19 syndrome will be calculated per person per covid episode. HCRU will be measured by total cost incurred during health care visits.<br> | | 31/12/2022 | | No | False | | |
| ISRCTN96796566 | 1 November 2021 | Electrical stimulation for lung muscle rehabilitation in patients with COVID-19 | Neuromuscular electrostimulation (NMES) of skeletal muscles in the rehabilitation of patients with COVID-19 interstitial pneumonia | | Akademii Wychowania Fizycznego im. Jerzego Kukuczki w Katowicach | 21/10/2021 | 20211021 | ISRCTN | https://www.isrctn.com/ISRCTN96796566 | Recruiting | No | | | Both | 20/09/2021 | 40 | Interventional | Interventional randomized controlled trial (Treatment) | Not Applicable | Poland | | | | | | | Inclusion criteria: <br> 1. COVID-19 (positive RT-PCR test and interstitial pneumonia observed in CT scan),<br> 2. Clinically severe interstitial pneumonia with respiratory failure / pre ARDS (MEWS classification of 3-4 points),<br> 3. <90-92% SpO2 at rest<br> 4. Consent to participate in the study.<br> | Exclusion criteria: <br> 1. Unstable ischemic heart disease,<br> 2. Significant haemodynamic aortic stenosis,<br> 3. Valve defects requiring surgical correction,<br> 4. Complex ventricular arrhythmias,<br> 5. Implantation of a cardiac pacemaker, cardioverter-defibrillator (ICD) and cardiac re-synchronizing pacemaker (CRT),<br> 6. Acute myocarditis or pericarditis,<br> 7. Uncontrolled hypertension,<br> 8. End-stage renal disease and liver failure disease,<br> 9. Lack of consent to participate in the study.<br> | COVID-19 interstitial pneumonia <br>Respiratory | <br> The study will include patients with COVID-19 interstitial pneumonia documented with positive SARS-CoV-2 RT-PCR test result.<br> Single-center interventional randomized controlled trial.<br><br> The intervention will consist of 2 stages.<br> In the first stage, after tests completion (chest CT scan, gasometry measured with the SpO2 pulse oximeter, ECG, anthropometric indicators and laboratory tests ) and meeting the inclusion criteria, patients will be qualified by the attending physician to participate in the experiment.<br><br> In the second stage, COVID-19 patients will be randomly assigned to one of two groups:<br><br> 1/ In the first group NMES electrical stimulation will be conducted in 20 COVID-19 patients in addition to the standard treatment.<br> Quality of life will be tested with the Polish version of the CAT questionnaire. Each patient will be assessed also using the The MRC dyspnoea scale. The exercise tolerance and dyspnoea will be assessed according to the Borg scale.<br> Physical capacity will be assessed by selected ADL activities (e.g. sitting alone in bed with legs lowered, lifting both lower limbs separately at 30° and holding them in this position until tired, standing alone by bed, getting out of bed and sitting alone in a chair while standing by the bed, walking without help).The implementation of the above interventions will depend on the clinical condition of the patient and will be ordered by the attending physician.<br> Muscle electrostimulation (NMES) will be performed 5 times a week for 40 minutes under the supervision of a physiotherapist and will last for 3 weeks (15 sessions). NMES will be conducted on thigh muscles (20 mins) and cal | Quality of life in COVID-19 patients assessed with the Polish version of the CAT questionnaire at baseline and after treatment. | | 05/12/2021 | | No | False | | |
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| ISRCTN85436698 | 1 November 2021 | Phase III trial of inhaled SNG001 compared to placebo for the treatment of patients hospitalised due to moderate COVID-19 | A randomised, double-blind, placebo-controlled, phase III trial to determine the efficacy and safety of inhaled SNG001 for the treatment of patients hospitalised due to moderate COVID-19 | | Synairgen Research Ltd | 03/02/2021 | 20210203 | ISRCTN | https://www.isrctn.com/ISRCTN85436698 | Recruiting | No | | | Both | 12/01/2021 | 610 | Interventional | Multi-centre interventional double-blind placebo-controlled randomized clinical trial (Treatment) | Phase III | Argentina;Belgium;Brazil;Colombia;France;Germany;India;Israel;Italy;Mexico;Netherlands;Portugal;Romania;Serbia;Spain;United Kingdom;England;United States of America | Sophie | Hemmings |
Synairgen Research Ltd
Level F (810)
South Block
Southampton General Hospital
Tremona Road
| info@synairgen.com | +44 (0)2380 512800 | | Inclusion criteria: <br> 1. Male or female, =18 years of age at the time of consent<br> 2. Admitted to hospital due to the severity of their COVID-19<br> 3. Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay. Patients who had positive virus test for SARS-CoV-2 prior to hospitalisation will be randomised no later than 48 hours after hospital admission. If the virus test was performed more than 96 hours prior to hospitalisation, the test will have to be repeated in the hospital prior to randomisation. Only patients whose repeated virus test is positive will be randomised, no later than 48 hours after confirmation of SARS-CoV-2 infection. Patients who had positive virus test for SARS-CoV-2 after hospitalisation will be randomised no later than 48 hours after confirmation of SARS-CoV-2 infection<br> 4. Require oxygen therapy via nasal prongs or mask (OSCI score of 4)<br> 5. Provided informed consent<br> 6. Female patients must be =1 year post-menopausal, surgically sterile, or using a highly effective method of contraception<br> | Exclusion criteria: <br> 1. Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a validated molecular assay or validated antigen assay<br> 2. Non-invasive ventilation or high-flow oxygen (OSCI score of 5)<br> 3. Mechanical ventilation (continuous or intermittent CPAP or intubation) or admission to intensive care (OSCI score of =6)<br> 4. Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated antigen assay<br> 5. Any condition, including findings in the patients’ medical history or in the pre-randomisation study assessments that in the opinion of the Investigator, constitute a risk or a contraindication for the participation of the patient into the study or that could interfere with the study objectives, conduct or evaluation<br> 6. Participation in previous clinical trials of SNG001<br> 7. Current or previous participation in another clinical trial where the patient has received a dose of an Investigational Medicinal Product (IMP) containing small molecules within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or containing biologicals within 3 months prior to entry into this study<br> 8. Inability to use a nebuliser with a mouthpiece<br> 9. Inability to comply with the requirements for storage conditions of study medication in the home setting<br> 10. History of hypersensitivity to natural or recombinant IFN-ß or to any of the excipients in the drug preparation<br> 11. Females who are breastfeeding, lactating, pregnant or intending to become pregnant<br> 12. Previous SARS-CoV-2 vaccination<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> SNG001 or placebo, randomised via IWRS, 1:1 ratio.<br> Dose: two syringes of either SNG001 (per syringe; 0.65 ml of drug product solution at a concentration of 12 MIU/ml) or placebo (per syringe; 0.65 ml of excipients only) taken once daily for 14 days.<br> | <br> 1. Time to hospital discharge, considered when Ordinal Scale for Clinical Improvement (OSCI) score is 2 (limitation of activities) or below with no rebound at subsequent assessments, from day 1 until day 28<br> 2. Time to recovery, defined as an OSCI score of 1 (no limitation of activities) or below with no rebound at subsequent assessments, from day 1 until day 28<br> | | 04/01/2022 | | No | False | | |
| → | ISRCTN10989132 | 1 November 2021 | ASK: Improving access to kidney transplantation | The ASK trial: a two-arm, parallel group, pragmatic individually-randomised controlled feasibility trial of a complex multicomponent intervention to improve AccesS to Kidney transplantation | | University of Bristol | 06/11/2020 | 20201106 | ISRCTN | https://www.isrctn.com/ISRCTN10989132 | Recruiting | No | | | Both | 18/10/2021 | 60 | Interventional | Two-arm parallel group pragmatic individually-randomised controlled feasibility trial of a complex multicomponent intervention (Other) | Not Applicable | United Kingdom;England→England;United Kingdom | | | | | | | Inclusion criteria: <br> 1. English-speaking adults (age =18 years)<br> 2. Individuals active on the UK Kidney Transplant only waiting list<br> 3. Individuals who do not have any potential living kidney donors currently undergoing surgical assessment for donation<br> | Exclusion criteria: Individuals who lack the Mental Capacity (as determined by their healthcare team) to consent to participation. | Improving access to living-donor kidney transplantation for people with advanced kidney disease <br>Urological and Genital Diseases <br>Renal disease | <br> Intervention arm participants receive:<br> • Clinician letter to potential donors regarding transplant need and option of living kidney donation plus simple-language living kidney donation information sheet. Links to educational animations.<br> • Home-based patient and family education and engagement. Education on living with kidney disease and treatment options. Simple-language living kidney donation information, educational animations, and facilitated discussions regarding donation. Remote virtual ‘visit’/link as optional alternative to home visit if restrictions on home visits related to Covid-19.<br><br> Control arm participants receive:<br> • Usual care<br><br> Total duration of follow-up for both study arms – 3 months.<br><br> Randomisation of eligible individuals with concealed allocation will be undertaken using internet-based REDCap software with the support of the Bristol Randomised Trials Collaboration (BRTC) of the Bristol Trials Centre using minimisation. Participants will be randomly allocated 1:1 to the intervention arm or to the usual care arm, stratified by site to ensure a balance in terms of local differences.<br> | <br> 1. Recruitment: % of those eligible and approached who consent to randomisation at invitation<br> 2. Retention: % completing follow up questionnaire approximately 4 weeks after baseline visit questionnaire<br> | | 01/02/2023 | | Yes | False | | |
| ISRCTN33260034 | 1 November 2021 | Adalimumab for coronavirus in community care | Adalimumab in COVID-19 to prevent respiratory failure in community care (AVID-CC): A randomised controlled trial | | University of Oxford | 20/08/2020 | 20200820 | ISRCTN | https://www.isrctn.com/ISRCTN33260034 | Not Recruiting | Yes | | | Both | 20/10/2020 | 750 | Interventional | Multi-centre interventional open label randomised controlled trial (Treatment) | Phase II | United Kingdom;England | Duncan | Richards |
OCTRU, Botnar Research Centre
Windmill Road
| duncan.richards@ndorms.ox.ac.uk | +44 (0)1865223462 | | Inclusion criteria: <br> 1. Aged =18 years<br> 2. Confirmed SARS-CoV-2 infection based on a validated test<br> 3. CRP >50 mg/l or lymphopaenia (<1.5 x 10(9)/l) or neutrophilia (>7.5 x 10(9)/l)<br> 4. Oxygen saturation >93% on air (pulse oximeter)<br> Note: Point of care testing and the associated results are acceptable for assessment of eligibility<br> | Exclusion criteria: <br> 1. Subject is considered to be in their last few weeks of life prior to this acute illness<br> 2. Clinical frailty score of 8 or 9 prior to this acute illness<br> 3. History of haematopoietic stem cell transplant or solid organ transplant<br> 4. Chronic obstructive pulmonary disease (COPD) on long term oxygen therapy (Subjects with FEV1 known to be <50% will also be excluded)<br> 5. Concomitant use of DMARDs (including csDMARDs, tsDMARDs and bDMARDs) or other immuno-suppressants<br> 6. Previous malignancy and lymphoproliferative disorders (within the last 5 years) with the exception of stable prostate cancer and basal cell carcinoma<br> 7. Current participation in another therapeutic interventional clinical study for COVID-19<br> 8. De-myelinating disease<br> 9. Known to be co-infected with Hepatitis B Virus, HIV<br> 10. Severe hepatic impairment<br> 11. Acute Kidney Injury Stage 3 (NHS England Acute Kidney Injury algorithm)<br> 12. Patients with tuberculosis or other severe infections such as (non-COVID-19) sepsis, abscesses, fungal superinfection and opportunistic infections requiring treatment.<br> 13. Moderate or severe heart failure (NYHA class III/IV)<br> 14. Treatment with anti-TNF drug in past 180 days (9 half lives of the drug)<br> 15. Pregnancy<br> 16. Lactating females<br> 17. Women of childbearing potential who are unwilling to use effective contraception (i.e. barrier, oral contraceptive pill, implanted contraception, or previous hysterectomy, bilateral oophorectomy) for the study and 5 months afterwards<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> Intervention: Adalimumab<br><br> Regimen 1. A loading dose of 80 mg adalimumab given as two injections of 40 mg at separate sites in the thigh or abdomen. Subjects with persistent symptoms and signs may receive a second dose of adalimumab 40 mg after 14 days.<br><br> Regimen 2. A loading dose of 160 mg adalimumab given as four injections of 40 mg at separate sites in the thigh or abdomen. Subjects with persistent symptoms and signs may receive a second dose of adalimumab 80 mg after 14 days.<br><br> This is in addition to standard care as per local Hospital at Home network treatment pathways.<br><br> Note: The second regimen will start recruitment following a preliminary assessment of safety of the first regimen (25 subjects randomised to regimen 1).<br><br> Comparator: Standard care as per local treatment pathways for those with confirmed COVID-19 being managed in the community.<br><br> Participants will be followed up for up to 120 days.<br><br> Eligible patients will be randomised using the centralised validated computer randomisation program through a secure (encrypted) web-based service, RRAMP (https://rramp.octru.ox.ac.uk), provided by the Oxford Clinical Trials Research Unit (OCTRU), accessed via the study’s RedCap instance, with a minimisation algorithm to ensure balanced allocation across treatment groups, (incorporating a non-deterministic random element) to include age, gender and presence of metabolic or cardiovascular co-morbidities in a 1:1 ratio to either adalimumab (2 regimens) with standard usual care or standard usual care. Within the adalimumab arm, following the review of the initial 25 patients who will receive regimen one, patients within adalimumab will be randomly a | Rate of progression to severe disease as defined by severe illness, or critical illness, or death from any cause in community care patients with COVID-19 at 28 days from randomisation measured using patient records | | 31/12/2021 | | Yes | True | parent | |
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| IRCT20201214049709N1 | 1 November 2021 | Phase I, Safety and Immunogenicity of Razi SARS-CoV-2 recombinant Spike protein vaccine (Razi Cov Pars) | Phase I, Safety and Immunogenicity of Razi SARS-CoV-2 recombinant Spike protein vaccine (Razi Cov Pars), in healthy adults aged 18-55 years; parallel 4 arms design (adjuvant only and three vaccine doses of 5, 10, and 20 µg/200µl); a Randomised, double blind, clinical trial | | Razi Vaccine and Serum Research Institute | 2021-01-21 | 20210121 | IRCT | http://en.irct.ir/trial/52975 | Not Recruiting | No | 18 years | 55 years | Both | 2021-01-29 | 133 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: In this study, we will use Block Randomization method with various block sizes. Excel software and rand() function will be used to prepare random order inside each block. When the intervention of each participant is determined, then a unique four-digit code will be assigned to the person (concealment). This number is the randomization code of the participant and the person will be identified with this number until the end of the study.
A chain of 133 random allocations for use in the first phase of the study will be kept by the study epidemiologist, Blinding description: In this study, a placebo will be used. The adjuvant used in the vaccine will be used as placebo. In this way, all study staff will be blinded to the type of intervention received by the participant. | 1 | Iran (Islamic Republic of) | Mohammad Hossein Fallah Mehrabadi | | Hesarak - Shahid Beheshti street- Karaj | mhf2480@yahoo.com | +98 26 3457 0038 | Razi Vaccine and Serum Research Institute | Inclusion criteria: Having Iranian citizenship;<br>Diploma or higher degree;<br>Adults aged 18 - 55 years;<br>Body mass index 17 to 35 kg/m2;<br>Having good health based on clinical and laboratory criteria;<br>Having sublingual temperature less than or equal to 37.2 ° C in the morning based on mercury thermometer;<br>Negative IgG and IgM antibody titers for COVID-19 S antigen;<br>Negative RT-PCR test for COVID-19;<br>Negative IgG ELISA for HIV;<br>Having heart rate between 60 and 100;<br>Signed the informed consent form;<br>The participant agrees to reduce the risk of developing of COVID-19;<br>For females of childbearing age 18 to 49 years: not being pregnant based on the first day of the last menstrual period;<br>For females of childbearing age 18 to 49 years: negative pregnancy test based on bHCG on the day of screening and the day of vaccination;<br>For females of childbearing age 18 to 49 years: use at least one effective method of contraception (condoms, oral contraceptive pills, intrauterine device, Norplant capsule) and willing to continue using it up to three month after last vaccine dose;<br>Unwillingness to have children and use effective methods of contraception up to three months after completion of vaccination (all participants).<br>Confirmation by a psychiatrist that the participant's mental health and capacity allows him/her to make a decision regarding his/her participation in the trial. | Exclusion criteria: Any ongoing, symptomatic acute or chronic illness requiring medical or surgical care on the day of vaccination;<br>Working in an occupation with a high risk of exposure to COVID-19 including medical staff, occupations with close contact with the client;<br>Breastfeeding;<br>Receipt any vaccine during the 30 days before the screening day;<br>Received blood and/or any blood products and/or immunoglobulins within three months preceding the screening day;<br>Any confirmed or suspected immunodeficient state;<br>History of long-term use of immunosuppressive medication (defined as more than 14 continuous days) in the last 4 months leading up to screening day;<br>Long-term use (defined as more than 14 continuous days) of systemic corticosteroids (equivalent to 10 mg or more daily prednisolone) within the past 4 months, except topical steroids;<br>History of allergic diseases such as angioedema or anaphylactic reactions;<br>History of any allergy to the drug or vaccine (defined as any clinical signs or symptom of itching at the injection site, urticaria in the body after injection, excessive redness at the injection site);<br>History of autoimmune diseases (other than controlled autoimmune thyroid disease, stable celiac disease, mild psoriasis, vitiligo that does not require corticosteroid or immunosuppressive therapy);<br>History of chemotherapy in the last 5 years;<br>History of cancer in the last 5 years;<br>History of serious psychiatric illnesses;<br>History of blood disorders (dyscrasia, coagulopathy, platelet deficiency or disorder, deficiency of blood factors);<br>Suffering from chronic obstructive pulmonary disease such as asthma and COPD that diagnosed by a specialist and is/was under medication;<br>Suffering from ischemic heart disease that is/was under medication by a specialist , history of cardiac interventions;<br>Suffering from hypertension that is/was under medication by a specialist ;<br>Suffering from diabetes that is/was under medication by a specialist ;<br>History of chronic neurological diseases (including seizures and epilepsy);<br>Any history of substance or alcohol abuse within the last 2 years;<br>Any abnormality in the hematology or biochemical laboratory tests based on FDA toxicity score (grade >1) on the screening day;<br>History of confirmed COVID-19;<br>Acute febrile illness at the time of vaccination;<br>History of acetaminophen allergy;<br>Acute or chronic hepatitis B and C;<br>Receiving prophylactic drug against tuberculosis;<br>History of syncope with blood transfusion or blood observation;<br>Splenectomy for any reason;<br>Any close contact with a confirmed COVID-19 case within two weeks before the first dose of vaccine;<br>History of SARS or MERS;<br>Participate in any clinical trials (research) study other than this study. | SARS-CoV-2. <br>COVID-19;U07.1 | Intervention 1: Intervention group 1: Vaccine at 5 µg/200µl dose; Participants in this group will receive two doses (IM) of RAZI recombinant spike protein vaccine 21 days apart followed by a 10 µg/200µl nasal spray 51 days after the first dose (day 0). Intervention 2: Intervention group 2: Vaccine at 10 µg/200µl dose; Participants in this group will receive two doses (IM) of RAZI recombinant spike protein vaccine 21 days apart followed by a 10 µg/200µl nasal spray 51 days after the first dose (day 0). Intervention 3: Intervention group 3: Vaccine at 20 µg/200µl dose; Participants in this group will receive two doses (IM) of RAZI recombinant spike protein vaccine 21 days apart followed by a 10 µg/200µl nasal spray 51 days after the first dose (day 0). Intervention 4: Control group: Adjuvant; Participants in this group will receive two doses (IM) of Adjuvant by 50% v/v concentation produced in RAZI institute 21 days apart followed by another dose in the form of nasal spray at day 51 (counted from day 0). | The number and percentage of people who shows abnormal laboratory findings, including biochemistry, hematology, and urine tests. These tests include: Hemoglobin, WBC, Lymphocytes cell, Neutrophils, Eosinophils, Platelets, ESR, CRP, LDH, Sodium, Potassium, HbA1c, BUN, Creatinine, Calcium, Alkaline phosphatase, ALT, AST, Bilirubin (total), Uric Acid, U/A, Urine protein, Urine glucose, Urine RBC. Timepoint: 7 Days after each vaccine dose (Days 7, 28, 58). Method of measurement: Each test will be performed using the appropriate kit.;The number and percentage of systemic adverse event within the first week post-vaccination (including nausea and vomiting, diarrhea, headache, fatigue, muscle pain) that will be assessed based on the severity score, duration and peak intensity. Timepoint: Seven days after each vaccination step (Days 0-7 and 21-27 and 51-57) daily assessment. Method of measurement: Daily symptom registration cards will be given to patients at the time of vaccination and they will be asked to bring them with themselves on the next visit. These patients will be contacted daily during these seven days and the study staff will ensure that the cards are completed.;The number and percentage of ocal adverse events within the first week post-vaccination (including pain, tenderness, erythema / redness, swelling and stiffness, itching) that will be assessed based on the severity score, duration and peak intensity. Timepoint: Seven days after 1st and 2nd vaccination(Days 0-7 and 21-27)daily assessment. Method of measurement: Daily symptom registration cards will be given to patients at the time of vaccination and they will be asked to bring them with themselves on the next visit. These patients will be contacted daily during these seven days and the study staff will ensure that the cards are completed.;Abnormal vital signs and anaphylactic reactions before and immediately after vaccination: number and percentages of participants who develop abnormal vital signs within three hours of receiving the vaccine at each doses will be recorded. Abnormal vital signs include temperature, respiratory rate, heart rate, systolic and diastolic blood pressure. Anaphylaxis is defined as an immediate systemic hypersensitivity simultaneously involving two systems. Anaphylactic reactions include: erythema, pruritus, urticaria and angioedema, bronchospasm, laryngeal edema, dizziness, hypotension, nausea, shortness of breath, wheezing, arrhythmia, cyanosis, vomiting, diarrhea, abdominal pain and will be checked up to three hours after each vaccination. Timepoint: Before vaccination and hourly for three hours after vaccination at each dose. Method of measurement: Clinical examination. | | | | Yes | False | | |
| → | IRCT20160815029373N7 | 1 November 2021 | The effect of exercise on the respiratory function of the elderly after COVID-19 | The effect of corrective and respiratory exercices on craniovertebral angle and respiratory function in elderly cases with history of COVID-19 | | The University of Guilan | 2021-09-01 | 20210901 | IRCT | http://en.irct.ir/trial/52992 | Recruiting | No | 50 years | 70 years | Both | 2021-08-23 | 30 | interventional | Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive. | N/A | Iran (Islamic Republic of) | Parisa Sedaghati | | 5th Kilometer of Persian Gulf Highway, Rasht, Guilan Province, Iran | sedaghati@guilan.ac.ir | +98 13 3369 0274 | University of Guilan | Inclusion criteria: More than three months have passed since the definitive diagnosis of COVID-19.<br>No COPD or other acute respiratory illness. | Exclusion criteria: Recurrence of corona disease<br>Not willingness to cooperation in this study | Coronavirus. <br>Coronavirus infection, unspecified;B34.2 | Intervention 1: Intervention group: Correctional and breathing exercises with conventional therapy, breathing exercises used in this study including deep breathing exercises, feathered death exercises, deep death exercises, deep inhaling and exhaling exercises with concentration, diaphragmatic breathing and three-step breathing. Intervention 2: Control group: Conventional treatments include medications prescribed by a doctor for side effects or other conditions such as a specific sleeping position or intensity of physical activity prescribed by a doctor. | Respiratory capacity. Timepoint: The beginning of the study and eight weeks later. Method of measurement: Spirometer.;Cranio vertebral angle. Timepoint: The beginning of the study and eight weeks later. Method of measurement: Guniameter.→Cranio vertebral angle. Timepoint: The beginning of the study and eight weeks later. Method of measurement: Guniameter.;Respiratory capacity. Timepoint: The beginning of the study and eight weeks later. Method of measurement: Spirometer. | | | | No | False | | |
| IRCT20210206050259N1 | 1 November 2021 | trial of safety, immunogenicity and dose finding for inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC) | Phase 1, safety, immunogenicity and dose finding for two strengths of 0.5 × 10^6 and 2.5 × 10^6 (TCID50) inactivated SARS-CoV-2 vaccine FAKHRAVAC (MIVAC) injected in two schedules of two doses, 2 and 3 weeks apart in healthy adults aged 18-55 years: a randomized, double blind, placebo controlled, clinical trial | | Organization of Defensive Innovation and Research | 2021-03-08 | 20210308 | IRCT | http://en.irct.ir/trial/54133 | Not Recruiting | No | 18 years | 55 years | Both | 2021-03-10 | 135 | interventional | Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Factorial, Purpose: Treatment, Randomization description: In this study, the Block Randomization method with different block sizes was used to assign each participant to the intervention groups. The rand() function of Excel software will be used to generate random sequence within each block. After determining the allocated intervention, a non-repetitive four-digit random code was assigned to each participant. Assigned codes will be delivered to the eligible participants via a software, Blinding description: In this study, placebo will be used. Adjunct only IMP will be used as placebo. All people involved in the study will be blind to the type of IMP received except the epidemiologist responsible for unblinding. In cases of any serious adverse event or any trend in the occurrence of adverse events towards one of the groups, unblinding will occur by DSMB request. In other clinical occasions unblinding co | 1 | Iran (Islamic Republic of) | Mohsen ForughiZadeh Moghadam | | No. 12, Zomorod 1 block, Noor 1 St.,Shahid Mahalati Town | Foroughizadeh@modares.ac.ir | +98 21 8008 6783 | Malek Ashtar University | Inclusion criteria: Age 18 to 55 years<br>Body mass index between 18 and 35 kg per square meter<br>Having complete health based on clinical and laboratory criteria<br>No current or previous COVID-19 disease<br>No pregnancy<br>Useing safe methods of contraception<br>Signing the informed consent form<br>Having Iranian citizenship<br>Participants should be able to read and understand informed consent, preferably with a diploma or higher certificate<br>Temperatures less than or equal to 37.2 ° C sublingually measured by an electronic thermometer<br>Negative IgG and IgM antibody titers against COVID-19 N antigen<br>Negative RT-PCR -test for SARS-CoV-2<br>IgG ELISA negative blood test against HIV<br>Heart rate between 60 and 100<br>Systolic blood pressure (between 90 and 140 mm Hg), diastolic blood pressure (between 60 and 90 mm Hg)<br>Accept commitments to reduce the risk of COVID-19<br>Negative pregnancy test for ß-hCG on the day of screening and the day of vaccination<br>Clinical trial participants should refrain from donating blood or plasma from the first vaccination until 3 months after the last vaccination.<br>Participants should not enter any other trial while in this study<br>Expressing a person's readiness to remain among the people monitored in the study for the entire study period until the research process is completed within 14 months<br>Use one of a safe method of contraception in men and women up to 3 months after the last dose of the vaccine | Exclusion criteria: Current acute or chronic symptomatic illness that requires ongoing medical or surgical care<br>high-risk occupations regarding risk of COVID-19, including medical staff, occupations with close contact with many client<br>Serving in compulsory military service (soldiers) in the subdivisions of the Armed Forces<br>Breastfeeding<br>History of receiving any research vaccine during the 30 days prior to the day of screening<br>History of transfusion of any blood product or immunoglobulin within the 3 months before the screening day<br>History of long-term use of immunosuppressive drugs or systemic corticosteroids in the last 4 months leading up to screening day<br>History of allergic diseases such as angioedema or anaphylactic reactions<br>History of any allergy to drugs or vaccines<br>History of cancer or chemotherapy in the last 5 years<br>History of serious psychiatric illnesses<br>History of blood disorders (Blood Dyscrasias, coagulation, platelet deficiency or disorder, etc)<br>Having chronic obstructive pulmonary disease such as asthma and COPD, ischemic cardiovascular disease diagnosed and treated by a specialist.<br>high blood pressure that is being treated by a doctor.<br>diabetes that is being treated by a doctor.<br>History of chronic neurological diseases (including seizures and epilepsy)<br>Any history of drug abuse (addiction) or alcohol consumption during the last 2 years<br>Any grade 1 toxicity in the hematology or biochemistry test results performed at the time of screening<br>History of confirmed COVID-19<br>Acute or chronic hepatitis B and C<br>Receiving prophylactic drug against tuberculosis<br>History of syncope with injection or blood observation<br>having a splenectomy for any reason<br>Any close contact with a definitively infected person with COVID-19 for a maximum of two weeks before the day of receiving the first dose | SARS-CoV-2. <br>U07.1 COVID-19, virus identified;U07.1 COVI | Intervention 1: Intervention group 1: Two times vaccines in the deltoid muscle (IM) with a dose of 0.5*10^6 (TCID50) at 14-day intervals. Intervention 2: Intervention group 2: Two times vaccines in the deltoid muscle (IM) with a dose of 2.5*10^6 (TCID50) at 14-day intervals. Intervention 3: Control group 1: Two times placebo in the deltoid muscle (IM) at 14-day intervals. Intervention 4: Intervention group 3: Two times vaccines in the deltoid muscle (IM) with a dose of 0.5*10^6 (TCID50) at 21-day intervals. Intervention 5: Intervention group 4: Two times vaccines in the deltoid muscle (IM) with a dose of 2.5*10^6 (TCID50) at 21-day intervals. Intervention 6: Control group 2: Two times placebo in the deltoid muscle (IM) at 21-day intervals. | Abnormal laboratory findings including Hemoglobin, WBC, Lymphocytes cell, Neutrophils, Eosinophils, Platelets, ESR, CRP, LDH,CPK, RT-PCR for SARS-CoV-2, Sodium, Potassium, BUN , Creatinine, Alkaline phosphatase, ALT, AST, Bilirubin (total), Uric Acid, U/A, Urine protein, Urine glucose, Urine RBC. Timepoint: 7 days after each vaccination. Method of measurement: Each test will be performed using the appropriate kit.;Systemic adverse event within the first week post-vaccination including nausea and vomiting, diarrhea, headache, fatigue, muscle pain, and other illnesses or clinical complications. Timepoint: For the first 7 days after each vaccination and then monthly for up to six months. Method of measurement: Study staff will contact participants daily for seven days and complete a systemic adverse event form.;Local adverse events within the first week post-vaccination including pain, tenderness, erythema and redness, and swelling and stiffness. Timepoint: For the first 7 days after each vaccination. Method of measurement: Study staff will contact participants daily for seven days and complete a local adverse event form.;Abnormal vital signs and anaphylactic reactions immediately after vaccination. Vital signs include body temperature, Respiratory rate, heart rate, systolic and diastolic blood pressure before and immediately after vaccination. Timepoint: In the first three hours after each vaccination. Method of measurement: Temperature is measured using a digital thermometer under the tongue. Heart rate and respiratory rate will be counted by the research staff in one minute. Blood pressure will be measured by a digital sphygmomanometer while sitting. | | | | Yes | False | | |
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| IRCT20210218050404N1 | 1 November 2021 | Control of inflammatory process in patients with coronavirus affected by ZAX.1399.C03 | Evaluation of anti-inflammatory effect of ZAX.1399.C03 on airways inflammation in patients with coronavirus in home care | | Fasa University of Medical Sciences | 2021-03-10 | 20210310 | IRCT | http://en.irct.ir/trial/54447 | Recruiting | No | 18 years | no limit | Both | 2021-06-21 | 60 | interventional | Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study is performed on patients referred to health centers and infectious disease specialists in the present study. For home care patients, the admit code along with the relevant information (medication regimen, age and sex, severity of the disease and severity of symptoms) is provided by the expert to the patient. The relevant expert divides the patients into two similar groups based on the treatment regimen, age group, sex, severity of the disease and symptoms, and randomly divides one group into group A and one group into group B using the patient code numbers. For randomization, the permutation block method with the number of blocks of 6 is done using Random allocation software, Blinding description: For blinding, the study of the drug and placebo with the names A and B in the same package are prescribed by the doctor to the patient. (Cap | 2-3 | Iran (Islamic Republic of) | Amin Dakhili Ardestani | | Fasa city, Ibn Sina Square, Fasa University of Medical Sciences | a.dakhili@fums.ac.ir | +98 71 5335 0996 | Fasa University of Medical Sciences | Inclusion criteria: COVID-19 is detected by PCR laboratory diagnostic kit<br>Age over 18 years<br>Both sexes (male and female)<br>Having informed and written consent to participate in the study<br>No history of any allergies<br>No uncontrolled hypertension<br>Do not take anticoagulants (aspirin, Plavix, warfarin)<br>Not pregnant and breastfeeding<br>No diabetes in the person | Exclusion criteria: Disagreement of the responsible physician of the patient before randomization<br>History of any allergies to drugs, various substances, food and ...<br>History of liver and kidney disease<br>Patient disagreement<br>Inability of the patient to take the drug for any reason<br>History of hypertension and heart disease | Incidence of inflammation due to the mechanism of COVID19. <br>COVID-19;U07.1 | Intervention 1: Intervention group: The medicinal composition of ZAX.1399.C03 in two daily doses, is consumed for 7 to 14 days. Intervention 2: Control group: The composition of popcorn flour is consumed, in two daily doses, for a period of 7 to 14 days. | Inflammatory mediators of IL6. Timepoint: Before the intervention and seven days after the start of consumption of mango leaf extract. Method of measurement: ELISA test.;Odor and taste activity. Timepoint: Daily. Method of measurement: Check list.;Shiver. Timepoint: Daily. Method of measurement: Check list.;Fatigue and laziness. Timepoint: Daily. Method of measurement: Check list.;Muscle and joint pain. Timepoint: Daily. Method of measurement: Check list.;Fever. Timepoint: Daily. Method of measurement: Check list.;Gastrointestinal manifestations. Timepoint: Daily. Method of measurement: Check list.;Shortness of breath. Timepoint: Daily. Method of measurement: Check list.;Sputum cough. Timepoint: Daily. Method of measurement: Check list.;Dry cough. Timepoint: Daily. Method of measurement: Check list. | | | | Yes | False | | |
| → | IRCT20210225050495N1 | 1 November 2021 | Evaluating the Effect of melatonin on mechanically ventilated COVID 19 patients | Evaluating the Effect of melatonin on mechanically ventilated COVID 19 patients in Intensive care unit | | Tehran University of Medical Sciences | 2021-10-01 | 20211001 | IRCT | http://en.irct.ir/trial/54619 | Recruiting | No | 18 years | no limit | Both | 2021-08-11 | 66 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: patients were randomized using Allocation random software (version 2.0) trough random block sizes of 4 and 6 with an allocation ratio of 1:1, to receive either melatonin or placebo. this is an open labeled study without blinding. | 2-3 | Iran (Islamic Republic of) | Hadiseh Hosamirudsari | | Baharloo Hospital- Behdari Street- Rah Ahan Square | h-hosami@sina.tums.ac.ir | +98 21 5565 8500 | Tehran University of Medical Sciences | Inclusion criteria: all covid-19 patients admitted to the ICU<br>Mechanically ventilated patients<br>within the first 24 hours of intubation | Exclusion criteria: liver enzyme more than 5 times of normal upper limit | critical COVID19. <br>U07.1 COVID-19, virus identified;U07.1 COVI | Intervention 1: Patients in melatonin group will receive 21mg of melatonin (Razak) every night for 5 days through nasogastric tubr. Intervention 2: Control group: Placebo group will receive placebo produced by Razak Company, every night for 5 nights. | The duration of the mechanical ventilation. Timepoint: at the end of the study. Method of measurement: Calculating the total days of mechanical ventilation.;In ICU Mortality Percent. Timepoint: At the end of the study. Method of measurement: The Number of Alive patients at the end of the study in each group.→In ICU Mortality Percent. Timepoint: At the end of the study. Method of measurement: The Number of Alive patients at the end of the study in each group.;The duration of the mechanical ventilation. Timepoint: at the end of the study. Method of measurement: Calculating the total days of mechanical ventilation. | | | | No | False | | |
| IRCT20201124049480N1 | 1 November 2021 | Efficacy of Levamisol in Treating COVID-19 | Evaluation of Levamisole efficacy in treatment of COVID-19 and comparing it to the ?common treatment: a Clinical Trial | | Artesh University of Medical Sciences | 2021-03-28 | 20210328 | IRCT | http://en.irct.ir/trial/54675 | Not Recruiting | No | 18 years | no limit | Both | 2021-04-21 | 365 | interventional | Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization (Permuted block randomization) will be used as the randomization method in this study. 6 quadruple blocks including AABB, ABAB, ABBA, BBAA, BABA, and BAAB are determined and then for each of the 4 patients, one of these 6 blocks will be used by a random number table. In fact, according to the order specified in each block, two patients will receive treatment A (treatment with levamisole) and two patients will receive treatment B (treatment without levamisole). | 3 | Iran (Islamic Republic of);Iran (Islamic Republic of);Iran (Islamic Republic of);Iran (Islamic Republic of);Iran (Islamic Republic of);Iran (Islamic Republic of);Iran (Islamic Republic of);Iran (Islamic Republic of);Iran (Islamic Republic of);Iran (Islamic Republic of) | Mohammad Aminianfar | | West Fatemi St. - End of Etemadzadeh St. - Aja University of Medical Sciences | maminianfar@yahoo.com | +98 21 4382 2449 | Artesh University of Medical Sciences | Inclusion criteria: Age 18 years or older<br>Positive RT PCR test for COVID-19<br>Full consent and acceptance of the patient or his companion for taking the drug<br>Patient traceability<br>Women should not become pregnant for 30 days after the end of the study<br>patients should not take levamisole for five days before entering the study (because the half-life of ?the drug is 16 hours) | Exclusion criteria: Another justifying cause (such as a bacterial or fungal infection) for the patient's symptoms<br>Allergic reaction to levamisole<br>Use of antibiotics other than those used to treat COVID-19<br>Shortness of breath due to cardiogenic pulmonary edema<br>Lactation<br>pregnancy<br>Patients with unstable hemodynamics;<br>History of cirrhosis, hepatitis, or severe liver disease,<br>GFR ?less than 30 ml/min<br>Patients receiving chemotherapy for cancer | outpatient covid19 infected individuals. <br>COVID-19;U07.1 | Intervention 1: Intervention group: Levamisole 50 mg/day for ten days + routine management for covid19 based on national protocol (Hydroxychloroquine tablets 200 mg daily, acetaminophen 500 mg every 6 hours in case of fever, naproxen 500 mg every 8 hours in case of myalgia, diphenhydramine syrup 10 cc every 8 hours in case of sore throat and cough, etc.). Intervention 2: Control group: routine outpatient management for covid19 based on national protocol (Hydroxychloroquine tablets 200 mg daily, acetaminophen 500 mg every 6 hours in case of fever, naproxen 500 mg every 8 hours in case of myalgia, diphenhydramine syrup 10 cc every 8 hours in case of sore throat and cough, etc.). | The general condition of the patient. Timepoint: Days 1,3,5,7,9,14. Method of measurement: Verbal Numeric Scale(VNS). | | | | Yes | False | | |
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| PACTR202006899597082 | 3 November 2021 | Efficacy of a new COVID-19 treatment | Randomized clinical trial, phase 2, to evaluate the efficacy of Artesunate IV alone or combined with vitamin C IV for the treatment of COVID-19 | | Malagasy government | 29/05/2020 | 20200529 | PACTR | https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=11103 | Not Recruiting | No | 19 Year(s) | 44 Year(s) | Both | 29/04/2020 | 60 | Interventional | Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Randomised,Stratified allocation where factors such as age, gender, center, or previous treatment are used in the stratification,Numbered containers | Phase-2 | Madagascar | MIORAMALALA | Sedera | Itaosy | sedera.mioramalala@gmail.com | +261341057733 | MD | Inclusion criteria: Adults aged between 18 to 70
<br>• COVID-19 confirmed by a RT-PCR test in real time 4 days before being enrolled in the clinical trial
<br>• Patients with moderate signs of COVID-19
<br>• Patients consenting voluntarily and freely | Exclusion criteria: Contraindications to the drug tested
<br>• Patients who require breathing apparatus (eg invasive ventilation, invasive mechanical ventilation, oxygenation of the extra-corporeal membrane)
<br>• Patients who participated in other clinical trials related to COVID-19
<br>• Patients who received medication directly treating COVID-19 24 hours before the start of the study. | <br>COVID-19;COVID-19 | ;Isotonic Saline Serum;Artesunate IV;Artesunate IV plus Vit C IV | This project will provide a better understanding of the efficacy of Artesunate IV alone or combined with Vitamin C in the form of Na-ascorbate compared to ISS in Madagascar in order to develop new strategies for the management of covid -19 adapted to the local context. | | | | No | False | | |
| → | PACTR202007589336711 | 3 November 2021 | Physiotherapy as a Complimentary treatment in Reducing Viral-Load, Complications, Death, Expedite Discharge and Improve Quality of Life, Exercise Endurance and Capacity in Stroke Survivors with COVID-19: A Clinical-Controlled Study | Physiotherapy as a Complimentary Treatment in Reducing Odds of Developing Complications, Expedite Hospital Discharge and Death in Stroke Survivors Positive for COVID-19: A Clinical Controlled Study | | Caleb Ademola Omuwa Gbiri | 04/06/2020 | 20200604 | PACTR | https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=11115 | Not Recruiting | No | 19 Year(s) | 44 Year(s) | Both | 13/07/2020 | 30 | Interventional | Parallel: different groups receive different interventions at same time during study,Non-randomised,Central randomisation by phone/fax | Not Applicable | Nigeria | Jibrin | Usman | Bayero University Kano Nigeria | jibrilphysio@yahoo.com | +2348099995088 | Lecturer College of Health Sciences Bayero University Kano Nigeria | Inclusion criteria: 1. Stroke survivors positive for CoViD-19 and age, sex and co-morbid health status-matched CoViD positive individuals
<br>2. The stroke survivors must have been discharge from in-patient stroke care unit | Exclusion criteria: 1. Must not primarily admitted for stroke or stroke complications
<br>2. Must have been discharged from inpatient stroke care and must have been receiving outpatient rehabilitation for at least one month before diagnosis of COVID19 | <br>Nervous System Diseases;Nervous System Diseases | ;Electronic Stroke Rehabilitation program in addition to their pharmacological treatment;Usual treatment for patients with CoViD19 apart from physiotherapy | Exercise tolerance;1. Cycle Threshold and Number of Nucleic Acid from Quantitative Real Time Polymerase Chain Reaction. →1. Cycle Threshold and Number of Nucleic Acid from Quantitative Real Time Polymerase Chain Reaction. ;Exercise tolerance | | | | Yes | False | | |
| PACTR202106466447805 | 3 November 2021 | A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia | A Randomized Double-blind Placebo-controlled Study to Evaluate the efficacy and Safety of Tocilizumab in Hospitalized Patients with COVID-19 Pneumonia | | Genentech Inc | 09/06/2020 | 20200609 | PACTR | https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=12137 | Not Recruiting | No | 19 Year(s) | 44 Year(s) | Both | 30/06/2020 | 379 | Interventional | Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomization using a randomization table created by a computer software program,Central randomisation by phone/fax | Phase-3 | Kenya;South Africa;South Africa;South Africa;South Africa;South Africa;Peru;Mexico;Brazil;United States of America;United States of America;United States of America;United States of America;United States of America;United States of America;United States of America;United States of America | Huwaida | Bulhan | The Atrium Chaka Road | huwaida.bulhan@roche.com | +254780888997 | Clinical Operations Lead SubSahara Africa | Inclusion criteria: Inclusion Criteria
<br>
<br>Hospitalized
<br>COVID-19 pneumonia confirmed by a positive polymerase chain reaction (PCR) of any specimen and radiographic imaging
<br>SpO2 < 94% while on ambient air | Exclusion criteria: Exclusion Criteria
<br>
<br>Known severe allergic reactions to TCZ or other monoclonal antibodies
<br>Require continuous positive airway pressure (CPAP), bilevel positive airway pressure (BIPAP), or invasive mechanical ventilation
<br>Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
<br>In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
<br>Immunocompromised (besides well-controlled HIV) or on immunosuppressive therapy (except for steroids for COVID), advanced cancer
<br>Have received oral anti-rejection or immunomodulatory drugs (including TCZ) within the past 3 months
<br>Participating in another interleukin (IL)-6 antagonist clinical trial or other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
<br>Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at screening (according to local laboratory reference ranges)
<br>Absolute neutrophil count (ANC) < 1000/uL at screening (according to local laboratory reference ranges)
<br>Platelet count < 50,000/uL at screening (according to local laboratory reference ranges)
<br>Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
<br>Treatment with an investigational drug within 5 half lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medical Monitor)
<br>Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study
<br>Any history of Diverticulitis or GI perforation
<br>Use of systemic corticosteroids unless on a stable chronic dose | <br>COVID19 Pneumonia;COVID19 Pneumonia | ;Tocilizumab;Placebo | Primary Outcome Measures :<br>Cumulative Proportion of Participants Requiring Mechanical Ventilation by Day 28 | 21/06/2021 | | https://pubmed.ncbi.nlm.nih.gov/33332779/ | Yes | False | | Yes |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| PACTR202012892855610 | 3 November 2021 | Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19 | A Prospective, Randomized, Multi-center, Open label, Interventional Study to Evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in Treatment of Adult Subjects with COVID-19 | | Oncotelic Incorporated | 22/11/2020 | 20201122 | PACTR | https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14510 | Not Recruiting | No | 19 Year(s) | 44 Year(s) | Both | 07/12/2020 | 120 | Interventional | Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomization using a randomization table created by a computer software program,Numbered containers | Not Applicable | Nigeria | Elijah | Sokomba | No 1 JB Leton close, Off Dan Isokrari close, Off Abdullahi Ibrahim Crescent. | esokomba@yahoo.com | +2348033185715 | Professor | Inclusion criteria:
<br>1. Male or female subjects of =18 to 60 years of age.
<br>2. Subjects willing to give informed consent and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
<br>3. Confirmed case of COVID-19 infection by RT-PCR and mild and moderate (without oxygen therapy or assisted ventilation) cases of COVID-19. Scores of 2-4 on the WHO Clinical Progression Scale
<br>4. Time interval between symptoms onset and randomization of no more than 7 days
<br>5. One or more of the following symptoms:
<br>? Fever
<br>? Cough
<br>? Sore throat
<br>? Headache
<br>Nasal congestion
<br>? Malaise
<br>? Diarrhea
<br>? Loss of smell
<br>? Loss of taste
<br>6. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study and for at least 30 days after the last dose of assigned treatment. A subject is of childbearing potential if, in the opinion of the investigator, he/she is biologically capable of having children and is sexually active.
<br> | Exclusion criteria:
<br>1. Subjects with history of severe infections (pneumonia, septicemia, etc.), severe cardiac or pulmonary diseases, or received immunosuppressive therapy or other investigational drugs within the previous 30 days of screening
<br>2. Known or suspected hypersensitivity to Artemisinin
<br>3. Women of child bearing potential who are currently pregnant, lactating or who are not willing to use contraception during the entire duration of the study
<br>4. Men who are unwilling to use contraception while receiving investigational product
<br>5. Subjects with history of severe disease other than COVID-19 which is expected to prevent compliance with the present protocol
<br>6. Subjects with history of severe renal and hepatic impairment. (creatine =2 mg/dl; liver enzymes and bilirubin 2.5 times ULN;alkaline phosphatase 1.5 times ULN)
<br>7. Recent treatment with Artemisinin or Artemisinin based antimalarials in the past 7 days
<br>8. Known history of failure to control systemic fungal, bacterial or viral infection
<br>9. Patients with the following co-morbidities: insulin-dependent diabetes, hypertension with cardiac symptoms, morbid obesity with diabetes and/or hypertension
<br>10. Subjects with known human immunodeficiency virus (HIV) or hepatitis B or C classes of active viral infection
<br>11. Have a history of neurological or psychiatric disorders, including epilepsy or dementia
<br>12. Subjects for whom ventilator support is required at screening
<br>13. Patients not willing to stay in hospital for 5 days of isolation following diagnosis of Covid-19
<br>14. Subjects not willing to give their informed consent to participate in the clinical trial Subjects having uncontrolled diabetes, uncontrolled hypertension.
<br>16. According to the investigator's judgment, there are concomitant diseases with a serious safety hazard or affect the subject
<br>17. Using other experimental drugs or participating in other clinical trials in the prior one month.
<br> | <br>Corona Virus COVID-19;Corona Virus COVID-19 | ;Artemisinin group ;Standard of Care | Relief in the sign and symptoms of COVID-19 as per WHO Clinical Progression Scale;• Adverse events (AEs) during the study | | | | Yes | False | | |
| → | PACTR202012898601759 | 3 November 2021 | PHASE 2 TRIAL: EVALUATION OF SILYMARIN FOR TREATMENT OF PATIENTS WITH COVID-19 | EVALUATION OF THE INHIBITORY ACTIVITIES OF SILYMARIN AGAINST SARS-CoV-2 . COVID-19 | | Africa Centre of Excellence in Phytomedicine Research and Development ACEPRD | 03/12/2020 | 20201203 | PACTR | https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14547 | Not Recruiting | No | 2 Year(s) | 5 Year(s) | Both | 20/12/2020 | 314 | Interventional | Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomization using a randomization table created by a computer software program,Allocation was determined by the holder of the sequence who is situated off site | Phase-2 | Nigeria;Nigeria | Simeon;Emmanuel→Emmanuel;Simeon | Omale;Nnadi | Africa Centre of Excellence in Phytomedicine Research and Development, No. 1, Road 4, University of Jos Senior Staff Quarters, Bauchi Road/Bauchi Ring-Road;Plateau State University Bokkos | soluv04@gmail.com;eennadi@gmail.com | +2348037009165;+2348068124819 | Safety lead;Microbiologist | Inclusion criteria: 1. Positive SARS COV-2 RT-PCR
<br>2. Age > 6 weeks and above
<br>2. Had not received any of the study drugs for at least one day
<br> | Exclusion criteria: 1. Unable to take oral medications
<br>2. Pregnancy
<br>4. Severe immunocompromised
<br>5. Known contraindications to study drugs
<br> | <br>COVID 19;COVID 19 | ;Silymarin based combination; Chloroquine | Clinical recovery from start of treatment | | | | Yes | False | | |
| → | PACTR202102846261362 | 3 November 2021 | Using community influencer groups to address COVID-19 misinformation and potential vaccine hesitancy in Uganda | Using community influencer groups to address COVID-19 misinformation and potential vaccine hesitancy in Uganda: a prospective, comparative, two-arm, quasi-experimental study | | Makerere University | 22/01/2021 | 20210122 | PACTR | https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14631 | Not Recruiting | No | 13 Year(s) | 18 Year(s) | Both | 01/02/2021 | 632 | Interventional | Parallel: different groups receive different interventions at same time during study,Non-randomised | Not Applicable | Uganda | Freddy | Kitutu | New Mulago Gate Road | kitutufred@gmail.com | +256705791777 | Project Lead | Inclusion criteria: Healthy men and women aged 18 years to 65 years older who normally reside in households in the selected villages, domestic servants who have slept for five nights a week or more in the households, and visitors who have slept in the household for at least the past four weeks will be eligible to participate in the study. | Exclusion criteria: Men and women from households that are under COVID-19 isolation or quarantine at the time of data collection will be excluded from the study if they do not have access to a phone for phone interviews to be conducted. | <br>COVID-19;COVID-19 | ;Community influencer groups;Control | The proportion of community members with COVID-19 misinformation. ;The proportion of community members with hesitancy towards a future COVID-19 vaccine→The proportion of community members with hesitancy towards a future COVID-19 vaccine;The proportion of community members with COVID-19 misinformation. | | | | Yes | False | | |
| PACTR202101875903773 | 3 November 2021 | A novel drug combination and route for COVID-19 treatment | The use of topical (Nasal and oropharyngeal) Povidone iodine plus topical Glycyrrhizic acid and oral Glycyrrhizic acid syrup for prevention and treatment of early COVID-19 cases. | | Hazem Elsersy | 22/01/2021 | 20210122 | PACTR | https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=14632 | Not Recruiting | No | 6 Year(s) | 12 Year(s) | Both | 26/01/2021 | 200 | Interventional | Parallel: different groups receive different interventions at same time during study,Randomised,Permuted block randomization,Central randomisation by phone/fax | Not Applicable | Egypt | Dr. Magdy | Zahran | Nasr city | magdyzahran@gmail.com | 00201007208275 | Professor of organic chemistry Faculty of science Menofia University. | Inclusion criteria: COVID-19 PCR positive patients of both genders aging 6 to 70 years having no symptoms or early symptoms such as loss of taste and smell, fever, cough with good O2 saturation. | Exclusion criteria: Patients with CT evidence category 4 or 5.
<br>Patients with dropped O2 saturation below 90 on room air.
<br>Patients with uncontrolled hypertension or diabetes mellitus.
<br>Ventilated patients or those with multiorgan failure.
<br> | <br>Corona virus;Corona virus | ;Povidone Iodine plus Glycyhrrizic acid nasopharyngeal spray plus Glycyrrhizic acid syrup;Positive control group | The primary outcome will be the PCR result for corona virus on day 4 and day 10. This will be done for the early treatment experiment;number of treated close contacts getting infected with corona virus in both groups | | | | Yes | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| PACTR202108837577420 | 3 November 2021 | Effect of Antimicrobial Mouthwashes on the Detection of SARS-COV-2 in Ghana | Viral shedding dynamics and the effect of antimicrobial mouthwashes on the detection of SARS-COV-2 in Ghana | | National Research Foundation South Africa | 15/03/2021 | 20210315 | PACTR | https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15753 | Not Recruiting | No | 19 Year(s) | 44 Year(s) | Both | 01/08/2021 | 216 | Interventional | Parallel: different groups receive different interventions at same time during study,Randomised,Simple randomization using a randomization table created by a computer software program,Sealed opaque envelopes | Phase-3 | Ghana;Ghana | Paa Kwesi | Blankson | Department of Oral and maxillofacial surgery Korle Bu teaching Hospital | pkblankson@yahoo.com | +233208887878 | Dental Surgeon Korle Bu teaching Hospital | Inclusion criteria: Ghanaian adults with confirmed diagnoses of COVID-19
<br>Persons who are willing, and consent to be part of the study
<br> | Exclusion criteria: Critically ill COVID-19 persons
<br>Medical condition, laboratory finding, or physical exam finding that precludes participation
<br>Persons who are allergic to any of the antimicrobial agents to be tested
<br>Persons with illnesses that prevent them from talking
<br>Pregnant and breastfeeding women
<br> | <br>COVID-19;COVID-19 | ;Chlorhexidine mouth wash;Wokadine Mouthwash;Hydrogen Peroxide Mouthwash ;Warm saline mouth rinse | A reduction in viral load of SARS-CoV-2 | | | | Yes | False | | |
| → | PACTR202103601407640 | 3 November 2021 | Clinical trial, phase 3, to evaluate the efficacy of CVO + for the treatment of COVID-19. | Randomized clinical trial, phase 3, to evaluate the efficacy of CVO + versus placebo for the treatment of COVID-19. | | PHARAMALAGASY | 19/03/2021 | 20210319 | PACTR | https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15764 | Recruiting | No | 19 Year(s) | 44 Year(s) | Both | 18/01/2021 | 338 | Interventional | Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously,Randomised,Simple randomization using a randomization table created by a computer software program,Central randomisation by phone/fax | Phase-3 | Madagascar | Sedera Aurelien;Dominique→Dominique;Sedera Aurelien | MIORAMALALA;Razafimandimby | CNARP;Military Hospital | sedera.mioramalala@gmail.com;domrazafimandimby9@gmail.com | +261341057733;+261340500709 | Data Manager CNARP;Clinician | Inclusion criteria: Study participant (or legally authorized representative) provides written informed consent prior to initiation of any study procedures.
<br>Understands and agrees to comply with planned study procedures.
<br>Agrees to the collection of OP swabs and venous blood per protocol.
<br>Male or non-pregnant female adult =18 years of age at time of enrolment.
<br>Laboratory-confirmed SARS-CoV-2 infection as determined by PCR nasopharyngeal swab.
<br>Illness of any duration, and at least one of the follow ing:
<br>Clinical assessment (evidence of rales/crackles on exam) or
<br>Requiring mechanical ventilation and/or supplemental oxygen.
<br>Creatinine = 110 umol/L, creatinine clearance rate (EGFR) = 60 ml / min / 1.73m2, AST and ALT = 5 × ULN, TBIL = 2 × ULN;
<br>A Normal ECG Baseline result, which is maintained throughout the study.
<br> | Exclusion criteria: • ALT/AST > 5 times the upper limit of normal.
<br>• Stage 4 severe chronic kidney disease or requiring dialysis (i.e. eGFR < 30)
<br>• Pregnancy or breast feeding.
<br>• Anticipated transfer to another hospital w hich is not a study site w ithin 72 hours.
<br>• Allergy to any study medication
<br>• Shortness of breath in resting position
<br>• Known prolonged QT syndrome
<br>• Use of concomitant medications that prolong the QT/QTc interval
<br>• Participant with other viral pneumonia
<br>• Participants with allergies to artemisinin containing products
<br>• History of allergic reactions to any investigational medical product ingredient | <br>COVID-19;COVID-19 | ;CVO plus;Placebo | complete clearance of viral load or significant progressive reduction of the viral load in OP swabs on days 28 | | | | No | False | | |
| PACTR202104601572565 | 3 November 2021 | SPUTNIK-LIGHT. COVID-19 | A Phase III, Randomized, Double Blind, Placebo-Controlled International Multisite Clinical Trial in Parallel Assignment to Evaluate Efficacy, Immunogenicity and Safety of the Sputnik Light Vector Vaccine in Adults in the SARS-CoV-2 Infection Prophylactic Treatment. COVID-19 | | Limited Liability Company Human Vaccine part of the group of the entities of JointStock Company Management Company of Russian Direct Investment Fund | 12/04/2021 | 20210412 | PACTR | https://pactr.samrc.ac.za/TrialDisplay.aspx?TrialID=15817 | Not Recruiting | No | 19 Year(s) | 44 Year(s) | Both | 01/05/2021 | 2000 | Interventional | Parallel: different groups receive different interventions at same time during study,Randomised,Dynamic (adaptive) random allocation such as minimization,Allocation was determined by the holder of the sequence who is situated off site | Phase-3 | Ghana | Alberta | Amu | Dodowa Health Research Centre. Box DD1, Dodowa, Ghana | alberta.amu@gmail.com | +233244274807 | Clinical Epidemiologist | Inclusion criteria: 1. Agree to sign the study informed consent form (ICF) before performing any study-specific procedure.
<br>2. Adults = 18 years old
<br>3. Absence of COVID-19 that is confirmed with negative immunochromatographic SARS-CoV-2 antigen rapid test at randomization test use of point of care test system at the screening visit
<br>4. Consent for using effective methods of contraception during the entire trial and 3 months after its completion
<br>5. No evidence of pronounced vaccine-induced reactions or complications after receiving immunobiological products in medical history.
<br>6. No acute infectious and/or respiratory diseases within at least 14 days before the enrollment.
<br> | Exclusion criteria: Inclusion criteria:
<br>1. Agree to sign the study informed consent form (ICF) before performing any study-specific procedure.
<br>2. Adults = 18 years old
<br>3. Absence of COVID-19 that is confirmed with negative immunochromatographic SARS-CoV-2 antigen rapid test at randomization test use of point of care test system at the screening visit
<br>4. Consent for using effective methods of contraception during the entire trial and 3 months after its completion
<br>5. No evidence of pronounced vaccine-induced reactions or complications after receiving immunobiological products in medical history.
<br>6. No acute infectious and/or respiratory diseases within at least 14 days before the enrollment.
<br>
<br>Exclusion criteria:
<br>1. Any previous vaccination/immunization (except for COVID-19 vaccination) within 30 days before the enrollment and any planned vaccination within 30 days after enrollment.
<br>2. Any previous COVID-19 vaccination or planned vaccination against COVID-19 with another vaccine approved by the regulatory authority
<br>3. Positive SARS-CoV-2 screening result obtained by PCR at screening
<br>4. Administration of steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products therapy not finished 30 days before the enrollment.
<br>5. Pregnancy or breast-feeding
<br>6. Acute coronary syndrome or stroke suffered less than one year before study enrollment
<br>7. Tuberculosis, chronic systemic infections associated with immunocompromised subjects in medical history
<br>8. History of severe allergic reaction to drug or vaccine (anaphylactic shock, Quincke's edema, and other life-threatening allergic reactions), acute exacerbation of allergic diseases on screening and vaccination day.\
<br>9. Chronic immune disease or systemic collagenosis in medical history
<br>10. Subjects who received transplantation and on immunosuppressive therapy
<br>11. Other immunosuppressive therapy that completed less than three months prior to randomization into the study
<br>12. Splenectomy in the past medical history
<br>13. Subjects with oncological disease within 5 years prior to inclusion into the study
<br>14. Neutropenia (absolute neutrophil count less than <1000/mm2), agranulocytosis, significant loss of blood, severe anemia (hemoglobin < 80 g/l) Immunodeficiency in the medical history within 6 months before the enrollment
<br>15. Active form of a disease caused by the human immunodeficiency virus, syphilis, hepatitis B, or C
<br>16. Acute Kidney injury or dialysis
<br>17. Anorexia or Malnutrition
<br>18. Tattoos or scars at the injection site (deltoid muscle area), which in the medical opinion of the investigator does not allow assessing the local response to the study vaccine/placebo administration
<br>19. Alcohol or Drug addiction in medical history
<br>20. Participation in other interventional clinical trial within the previous 90 days prior to vaccination and over duration of the trial
<br>21. Any other condition that the study physician considers as a barrier to the trial completion as per the protocol.
<br> | <br>COVID 19 /SARS-CoV-2 Infection Prophylactic Treatment;COVID 19 /SARS-CoV-2 Infection Prophylactic Treatment | ;Sputnik Light Vector Vaccine;Placebo | Primary Endpoints: <br>1. Proportion of study subjects with active COVID-19 disease developed 21±2 days after vaccination with the Sputnik-Light vector vaccine as compared with placebo<br>2. Incidence and severity of adverse events in trial subjects:<br>a. Incidence of local and systemic reactions to the vaccine in 7 days after injection with vaccine/placebo<br>b. Incidence and severity of AEs and SAEs over the course of subject’s participation in the study<br> | | | | Yes | False | | |
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| RBR-9pgwfc | 2 November 2021 | Psychological effects of social isolation in the coronavirus pandemic | Psychological effects of preventive isolation in the COVID-19 pandemic | | Hospital Universitário Bettina Ferro de Souza | 09/04/2020 | 20200409 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-9pgwfc | Recruiting | No | 18Y | 90Y | - | 07/04/2020 | | Observational | Retrospective observational analytical case-control study. | N/A | Brazil;Canada;Chile;Colombia;France;Portugal;Spain;United Kingdom;United States | Janari | Pedroso | Rua Augusto Corrêa, 01 | pedrosoufpa@gmail.com | +5591982893370 | Universidade Federal do Pará | Inclusion criteria: Healthy volunteers; both genders; age between 18 and 90 years. | Exclusion criteria: People under the age of 18. | Volunteers; pathological conditions, signs and symptoms;M01.955 | Initially, an online questionnaire (Portuguese, English, Spanish, French, Italian and German) will be applied to volunteer participants over 18 years old, selected by invitation on social media (Facebook, WhatsAPP). The questions will be on a platform on the internet. The participation of 2,300 participants is estimated. Filling takes an average of 10 minutes.;Other;E05.318.308.980;L01.143.539 | It is expected that social isolation will have an effect on the psychological parameters of optimism and affection of the studied populations, in a way that depends on cultural aspects related to socioeconomic conditions. | | | | No | False | | |
| → | RBR-9ktwx6 | 2 November 2021 | Effect of the use of Chloroquine and Hydroxychloroquine as a possible protector for Infection with the New Corona Virus 2019 in patients with Rheumatic Diseases | Evaluation of the effect of chronic use of Antimalarials on the frequency of infection with the New Corona Virus 2019 (Severe Acute Respiratory Syndrome Coronavirus 2 - SARS-CoV-2) in patients with Immunomedical Rheumatic Diseases | | Socidade Brasileira de Reumatologia | 09/04/2020 | 20200409 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-9ktwx6 | Recruiting | No | 18Y | | - | 30/03/2020 | | Observational | Prospective observational analytical cohort study | N/A | Brazil | cláudia | marques | rua de apipucos n 235 apt 702 apipucos | claudia.reumatologia@gmail.com | 55 (81) 92945459 | Universidade Federal de Pernambuco | Inclusion criteria: Age greater than or equal to 18 years; use of antimalarial drugs for at least 30 days before inclusion; diagnosis of immune mediated rheumatic disease defined according to American College of Rheumatology (ACR) or European League against Rheumatism (EULAR) criteria: rheumatoid arthritis (RA), systemic lupus erythematosus (SLE, Sjogren's syndrome (SS), systemic sclerosis, myopathies inflammatory diseases, mixed connective tissue disease (DMTC), systemic sclerosis (ES); diagnosis of osteoarthritis (OA) of hands (subgroup). | Exclusion criteria: Previous use of antimalarial, but not current in the last 6 months; history of solid organ or bone marrow transplantation; neoplasm of solid organs or lymphatic or myeloproliferative lineage in the last 12 months with or without adjuvant chemotherapy; use of intravenous human immunoglobulin in the last 30 days. | Severe Acute Respiratory Syndrome;
Rheumatic Diseases;C02.782.600.550.200.750;C05.799 | Through telephone contact, an interview will be conducted to collect data related to sociodemographic characteristics, details of the use of antimalarials and immune-mediated rheumatic diseases (indication, disease activity according to the patient's assessment), as well as comorbidities, smoking, alcoholism, concomitant medications. In addition, specific aspects related to the symptoms of COVID19 and epidemiological data in patients and in contacts from the same home and professional environment will be addressed, by telephone contact by a trained health professional.It is expected to interview 9,000 patients with rheumatic diseases and a proportion of 2 controls for each case (18,000);Other;V01.175.250 | To evaluate the incidence of SARS-CoV-2 infection, suspected or confirmed, during the follow-up period, comparing the frequency between the patient and his home contacts included in the study, according to the definitions of the Ministry of Health of Brazil.;Evaluate the need for hospitalization due to SARS-CoV-2 infection in patients with rheumatic diseases compared to their home contacts included in the study, including the following parameters: total hospitalization time, need for admission to the intensive care unit, need for mechanical ventilation during hospitalization;Determine the frequency of deaths in suspected or confirmed cases of SAR-Cov-2 infection in patients with rheumatic diseases by comparing with their home contacts included in the study→To evaluate the incidence of SARS-CoV-2 infection, suspected or confirmed, during the follow-up period, comparing the frequency between the patient and his home contacts included in the study, according to the definitions of the Ministry of Health of Brazil.;Determine the frequency of deaths in suspected or confirmed cases of SAR-Cov-2 infection in patients with rheumatic diseases by comparing with their home contacts included in the study;Evaluate the need for hospitalization due to SARS-CoV-2 infection in patients with rheumatic diseases compared to their home contacts included in the study, including the following parameters: total hospitalization time, need for admission to the intensive care unit, need for mechanical ventilation during hospitalization | | | | No | False | | |
| RBR-8969zg | 2 November 2021 | Treatment of 2019-nCoV Pneumonia with N-acetylcysteine | Clinical Trial using N-acetylcysteine for treatment of 2019-nCoV Pneumonia | | Universidade de São Paulo | 13/04/2020 | 20200413 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-8969zg | Not Recruiting | No | 18Y | | - | 14/04/2020 | | Intervention | Clinical trial, single-center, randomized, placebo-controlled, double-blind. | N/A | Brazil | Julio | Alencar | Av. Dr. Eneas de Carvalho Aguiar, 255 | julio.alencar@hc.fm.usp.br | +55-11-943960027 | Universidade de São Paulo | Inclusion criteria: Volunteers; Both genders; Admitted to the Emergency Department with diagnosis of Acute Respiratory Syndrome, presumed or confirmed; Age equal to or greater than 18 years; Informed consent form (ICF) signed by the patient or legal guardian. | Exclusion criteria: Patients with known allergy to N acetylcysteine; Pregnant women; In need of immediate mechanical ventilation or Refusal or inability to obtain consent | Severe acute respiratory syndrome; Viral Pneumonia;J12.8 | A total of 140 (one hundred and forty) patients diagnosed with severe acute respiratory syndrome will be invited to participate in the study, and, after signing the informed consent form, they will be randomized into two groups, which will be treated according to the protocol : Control Group (70 patients): will receive intravenous infusion in peripheral venous access of Placebo (Glucose 5% 100mL) in 20h (single dose). Intervention Group (70 patients): will receive intravenous infusion in peripheral venous access of N acetylcysteine in a total dose of 300 mg / kg, with the first dose being 200 mg / kg in 4 hours and the second dose 100 mg / kg in 16 hours ( Single dose). Serum tests (30mL of blood from peripheral venous access) and arterial blood gases will be collected from all patients. Patients will be monitored daily by reviewing medical records and clinical data will be recorded on a RedCap form.;Drug;V03.175.250;SP4.046.447.673 | Reduction in in-hospital mortality in 5%, verified by medical record analysis, in patients receiving N-acetylcysteine compared to the group receiving Placebo | | | | Yes | False | | |
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| RBR-3k4wxb | 2 November 2021 | Evaluation of the use of Hydroxychlorochine in Chinese flu
| Evaluation of the use of Hydroxychlorochine in patients with discrete form of Covid-19: randomized clinical trial | | Hospital Santo Antônio | 05/05/2020 | 20200505 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-3k4wxb | Not Recruiting | No | 18Y | | - | 01/05/2020 | | Intervention | Randomized, open, controlled, three arms treatment clinical trial | 2 | Brazil | Marcos Aurelio | Barboza de Oliveira | Av. dos Flamboyants, 2145 | maboliveira@gmail.com | +55-066-35171800 | Hospital Santo Antônio | Inclusion criteria: Positive RT-PCR; age> 18 years; discrete classification (without signs of dyspnea, and oximetry greater than 93%) | Exclusion criteria: Need for ICU on day 0; allergy to hydroxychloroquine or azithromycin; retinopathy; G6PD deficiency; QT extension; lactation; pregnancy; hepatic insufficiency; acute renal failure; patients who did not sign the informed consent | non specified coronavirus infection/ coronavirus;B34.2 | 1. Control group - 15 participants<br>The Control group will receive proper COVID19 treatment but will not receive hydroxychloroquine, chloroquine, azithromycin, or another macrolide.<br>PT-BR<br>EN<br>2. G1 - 15 participants<br>This group will receive proper COVID19 treatment and hydroxychloroquine 400mg + azithromycin 500mg bid D0, orally, or enterally, and the following days, hydroxychloroquine 400mg + azithromycin 500mg once each, orally, or enterally, for 10 days or negative PCR, what comes first. <br>3. G2 - 15 participants<br>This group will receive proper COVID19 treatment and hydroxychloroquine 200mg + azithromycin 500mg bid D0, orally, or enterally, and the following days, hydroxychloroquine 200mg + azithromycin 500mg once each, orally, or enterally, for 10 days or negative PCR, what comes first.;Drug;D03.633.100.810.050.180.350;D02.540.576.500.992.050 | Negative viral load; RT-PCR was taken from a negative oropharynx swab; the RT-PCR value must be literally zero (0) for the patient to be considered cured | | | | No | False | | |
| → | RBR-4vm3yy | 2 November 2021 | Effect of convalescent plasma in patients with severe COVI-19 | Use of convalescent plasma submitted to pathogen inactivation for the treatment of patients with severe COVID-19 | | Instituto Estadual de Hematologia Arthur Siqueira Cavalcanti | 15/05/2020 | 20200515 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-4vm3yy | Recruiting | No | 18Y | | - | 19/04/2020 | | Intervention | Non-randomized uncontrolled clinical trial | N/A | Brazil | Pedro␣;Pedro→Pedro;Pedro | Kurtz;Kurtz | Rua do Resende 156;Rua do Resende 156 | kurtzpedro@mac.com;kurtzpedro@mac.com | +5502122779352;2122779352 | Instituto Estadual do Cérebro Paulo Niemeyer ;Instituto Estadual do Cérebro Paulo Niemeyer | Inclusion criteria: Age > or equal to 18 years; Severe or critical-19 COVID-19; Length of stay < 3 days; Laboratory confirmation of COVID-19 by detection of the viral genome in respiratory secretions, collected by swab; Signature, by the patient or a relative, of the informed consent form | Exclusion criteria: Allergic reactions prior to plasma transfusion | Coronavirus infection; Sepsis;C01.925.782.600.550.200;C01.757 | Hyperimmune plasma anti-SARS-CoV-2<br>20 patients will be included and will be compared with historical controls, that were admitted before the start of the current study;Biological/vaccine;E02.095.465.425.400.330 | Temporal improvement in inflammatory biomarkers and organ dysfunction scores during ICU admission, measured by the daily reduction in 10% of biomarkers in plasma and respiratory secretions, per day for 14 days <br><br> | | | | No | False | | |
| RBR-62y3h7 | 2 November 2021 | Acute impairment of renal function in COVID-19: study on incidence, risk factors and mortality | Acute Kidney Injury in Infectious Coronavirus Disease: a study on incidence, risk factors and mortality | | Faculdade de Medicina de Botucatu | 18/05/2020 | 20200518 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-62y3h7 | Recruiting | No | | | - | 01/05/2020 | | Observational | Retrospective and prospective analytical observational cohort study | N/A | Brazil | Welder | Zamoner | Rua Damião Pinheiro Machado, 751, Apto 64 | welderzamoner@gmail.com | 55-11-997636310 | Departamento de Clínica Médica da Faculdade de Medicina de Botucatu | Inclusion criteria: suspected diagnosis of COVID-19 | Exclusion criteria: negative test for COVID-19; patients without diuresis control or at least two creatinine tests during hospitalization; pregnant women; age under 18; patients with advanced CKD (Cl Cr <30 ml / min; kidney transplant patients. | Acute renal failure; Coronavirus infection of unspecified location;B34.2 | One group of 1000 patients will be submitted a clinical evaluation of data collected obtained through patient consultation and medical records consecutively of all hospitalized patients diagnosed with COVID-19 until your discharge or death. The follow-up will take place in the period of 1 year, with daily analysis of the medical record performed by the same observer, with collection of general data and serial clinical and laboratory variables.;Other;E05.318.308.940.968.625.500;E01.370.225.124.100 | Assess the presence of acute kidney injury. The results will be presented using descriptive statistics of the studied population and the occurrence of AKI will be established as a dependent variable, using the Chi-Square Test for the statistical significance between this variable and the categorical variables and the t Test for this variable and the variables continuous. Afterwards, multivariate analysis will be performed, through the construction of a logistic regression model, with Odds Ratio (OR) calculations, including all independent variables that showed an association with the outcome, with p under 0.20. A similar procedure will be performed from the establishment, as a dependent variable, the occurrence of death. All results of the hypothesis tests will be discussed at the 5% significance level (p under 0.05) | | | | No | False | | |
| → | RBR-9d8z6m | 2 November 2021 | Safety and Efficacy of Hydroxychloroquine Associated With Azythromycin in SARS-Cov-2 Virus | Open and controlled trial of hydroxychloroquine and azytromicyn use to prevent complications in patients infected by new coronavirus (COVID-19): a randomized controlled trial - Brazil COVID Coalition I Trial | | Hospital do Coração | 27/03/2020 | 20200327 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-9d8z6m | Not Recruiting | No | 18Y | | - | 30/03/2020 | | Intervention | Randomized, open, controlled, three arms treatment clinical trial | 3 | Brazil | Alexandre;Fernando→Fernando;Alexandre | Cavalcanti;Zampieri | Rua Abílio Soares, 250, 11º andar.;Rua Abilio Soares 250, 12o. andar | abiasi@hcor.com.br;fzampieri@hcor.com.br | 11-3053-6611 ramal 8102;+551130536611 | Hospital do Coração;Hospital do Coração | Inclusion criteria: Patients admitted to the ICU or Hospital with suspected or confirmed COVID-19 | Exclusion criteria: Presence of any of the following: Need to supplement oxygen more than 4L; Use of high flow nasal catheter; Use of non-invasive ventilation; Use of mechanical ventilation; Use of hidroxichoroquine, chloroquine,
<br>azithromycin or other macrolide over 24 hours; History of severe ventricular or QTC equal or grater than 48 ms cardiac arrithmia; History of hepatic desease (cirrosis); Renal dysfunction (estimated glomerular filtration rate [eGFR] less than 30ml/min/1.73m2, using MDRD or CKD-EPI method); Patients with retinopathy or macular degeneration; Children under 18 years;Pregnancy; Allergy to chloroquine and derivatives; Allergy to azythromicyn; Patients in hospital over 48hr; Patients with symptoms over 14 days | non specified coronavirus infection/ coronavirus;B34.2 | 1. Control group - 210 participants<br>Control group will recieve proper COVID19 treatment but will not recieve hydroxychloroquine, chloroquine, azythromicyn or other macrolide.<br><br>2. HCQA - 210 participants<br>HCQA group will recieve proper COVID19 treatment and hydroxychloroquine 400mg + azythromicyn 500mg once a day, oral, enteral or intravenous, for 7 days<br><br>3. HCQ - 210 participants<br>HCQ group will recieve proper COVID19 treatment, and hydroxychloroquine 400mg once a day, oral, enteral or intravenous, for 7 days;Drug;D03.633.100.810.050.180.350;D02.540.576.500.992.050 | Outpatient, with limited activities;Death;Patient in mechanical ventilation;Patient in hospital with non-invasive ventilation or high flow cannula;Patient in hospital, with supplemental oxygen;Patient in hospital, without supplemental oxygen;Outpatient, without activity limitation;Evaluate patient's health condition after 15 days. The primary outcome is based on seven possible patient's health conditions whithin 15 days:<br> | | | | Yes | False | | |
| → | RBR-2dxyx4 | 2 November 2021 | Mechanical ventilator for use in patients with respiratory failure due to Covid-19 (VExCO) | Mechanical ventilator for use in patients with respiratory failure due to Covid-19 | | Hospital Universitário Clementino Fraga Filho | 02/06/2020 | 20200602 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-2dxyx4 | Not Recruiting | No | | | - | 04/06/2020 | | Intervention | Treatment clinical trial, single group, open, single arm. | N/A | Brazil | Diamantino;Dayane →Dayane ;Diamantino | Salgado;Vila Nova | PROFESSOR RODOLPHO PAULO ROCCO 255;Rua João Julião, 331 | d.salgado@globo.com;dvilanova@haoc.com.br | +552139382723;11 3549-0729 | Hospital Universitário Clementino Fraga Filho;Hospital Alemão Oswaldo Cruz | Inclusion criteria: Adults age greater than or equal to 18 years ;patients assisted in the ER with probable or confirmed infection by COVID-19; time between symptoms and inclusion less than or equal to 7 days; present mild symptoms, with no indication of hospitalization; present at least 1 risk factor for complication (age more than 65 years; hypertension; diabetes mellitus; bronchial asthma; COPD or other chronic lung diseases; smoking
<br>; immunosuppression; obesity | Exclusion criteria: Patients under 18 years old, hospitalization in the first care; positive test for influenza in the first visit; known hypersensitivity hydroxychloroquine / chloroquine; previous diagnosis of retinopathy or macular degeneration; previous diagnosis of QT-long syndrome; history of sudden death in close family members (parents and siblings), use of anti-arrhythmic drugs or others that may increase the bioavailability of hydroxychloroquine or enhance its effect, decompensated heart failure, symptomatic coronary artery disease; evidence of known liver disease, reported by the patient; evidence of known chronic kidney disease, reported by the patient, patients with pancreatitis, baseline ECG with QT interval greater than or equal to 480ms; chronic use of hydroxychloroquine / chloroquine for other reasons; pregnancy | Respiration, Artificial;C02.782.600.550.200 | Intervention: The trial will be conducted on 5 patients. The ventilator under test will be previously adjusted to provide the same adjustments as the ventilator used in therapy.<br>A quick maneuver, in about 30 seconds, will be performed: the oro-tracheal tube will be obstructed at the end of an exhalation, the ventilator will be disconnected from the patient and, immediately, the ventilator under test will be connected, including the pneumotachograph connected to the monitor of ventilatory quantities. The obstruction in the orotracheal tube will be removed and ventilatory therapy will restart. The ventilation parameters will be checked and, if necessary, readjusted to match the initial values previously used. The monitored values will be recorded and acquired. After 1 hour, the ventilatory adjustments of the ventilator under test will be recorded and the values monitored (Positive End Expiratory Pressure- PEEP, Plateau Pressure - PP, Respiratory Rate - FR, Ratio between the Inspiration and Expiration Time - Ratio I: E, Inspired Fraction of O2-FiO2, Total Volume - VT, Saturation of O2-SaO2). If the arterial line is present, blood gases will be collected and the arterial partial pressure values for oxygen (PaO2), arterial partial pressure of carbon dioxide (pacO2) and hydrogen potential (pH) will be recorded.<br>Then, in a maneuver identical to the first disconnection-connection, the ventilator under test will be disconnected from the patient and the original ventilator will be connected again. After 10 minutes, the same values already mentioned will be recorded for comparison purposes.<br>There is no control group in this trial.;Drug;D03.633.100.810.050.180.350 | Secondary Outcome<br><br>Clinically assess efficacy for the presence of uncontrolled asthma after 5 or more days of medication initiation through telephone contact by trained staff;Assess need for hospitalization due to a COVID-19 compatible cause within 30 days after hospitalization through telephone contact by a trained professional, as it is believed that 90% of hospital admissions due to SARS-Cov2 occur within the first 15 sick days. The outcome period of 30 days was chosen to capture the 10% of the remaining hospitalizations, which are outliers, which will happen between 15 and 30 days of illness. | | | | Yes | False | | |
| → | RBR-43hbks | 2 November 2021 | Evaluation with ultrasound on the bedside in serious patients with COVID-19 | Evaluation with point-of-care ultrasound in serious patients with COVID-19 - POCUS COVID-19: point-of-care ultrasound for covid-19 | | Disciplina de Cirurgia Vascular e Endovascular da Universidade Federal de São Paulo | 03/06/2020 | 20200603 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-43hbks | Recruiting | No | | 130Y | - | 21/04/2020 | | Observational | A prospective observational analytical cohort study | N/A | Brazil | Luis;Ronald→Ronald;Luis | Nakano;Flumignan | 754, Rua Borges Lagoa;754, Rua Borges Lagoa | luiscnakano@uol.com.br;flumignan@gmail.com | +551155764848;1155764848 | Disciplina de Cirurgia Vascular e Endovascular da Universidade Federal de São Paulo;Disciplina de Cirurgia Vascular e Endovascular da Universidade Federal de São Paulo | Inclusion criteria: patients admitted to the intensive care unit with a confirmed Covid-19 diagnosis | Exclusion criteria: covid-19 suspect patient (not yet confirmed) | Severe Acute Respiratory Syndrome; Coronavirus infections;C01.748.730;C01.925.782.600.550.200 | The only intervention proposed by the study is an evaluation with point-of-care ultrasonography (at the bedside) mainly for analysis of possible central access sites in pronated patients. There is no experimental intervention or control. There is no comparative group because it is a prospective observational cohort. As he is an ICU patient, he can be submitted to other drug treatments such as heparin, antibiotics, analgesics, among others that will be done at the discretion of the attending physician and will not suffer interference from the study.;Drug;Procedure/surgery;Other;N02.278.388.493 | It is expected to find new sites for the passage of central venous access for critically ill patients with COVID 19. It is intended to present the number and possible parameters for central venous access in pronated patients. | | | | No | False | | |
| RBR-949z6v | 2 November 2021 | Full versus prophylactic anticoagulation for the treatment of severe forms of Covid-19: | Full versus prophylactic heparinization for the treatment of severe forms of SARS-Covid-19: clinical, randomized, open and controlled study - HeSAcovid trial | | Faculdade de Medicina de Ribeirão Preto | 06/05/2020 | 20200506 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-949z6v | Recruiting | No | 18Y | | - | 30/05/2020 | | Intervention | Clinical trial of treatment, randomized-controlled, parallel, open, with two arms: first group will use full heparinization with enoxaparin corrected for creatinine clerance, compared with prophylactic heparinization through unfractionated heparin 5000 IU SC 8/8 hs ( 7500 IU 8/8 h in patients> 120Kg) or enoxaparin 40 mg SC 1 x day (40 mg BID if weight> 120 Kg) in patients with confirmed SARS-CoV-2 infection through RT-PCR and with severe clinical presentation respiratory failure requiring mechanical ventilation or refractory to oxygen therapy (maintenance of respiratory rate> 24 ipm and saturation <90% with oxygen catheter at 4 liters / min). The following tests will be collected: blood gas, lactate, D-dimer, PCR, biomarkers of endothelial glycocalyx lesion (syndecan-1, hyalurane, thrombomodulin, heparan sulfate, soluble CD44, chondroitin sulfate) at the time of inclusion (D0) and after 96 hours of heparinization (D4). The primary outcomes are: comparison between before and after | 2 | Brazil | Carlos | Miranda | Rua Bernardino de Campos, 100 | chmiranda@fmrp.usp.br | +55-16-32371470 | Faculdade de Medicina de Ribeirão Preto | Inclusion criteria: Age above or equal to 18 years; SARS-covid-19 infection confirmed through RT-PCR; Severe forms confirmed by the presence of ARDS according to the Berlin classification ( bilateral infiltrate on chest X-ray, arterial hypoxemia with a PaO2 / FIO2 ratio <300, absence of structural heart disease or evidence of insufficiency acute cardiac arrest; Presence of severe clinical presentation with respiratory failure requiring orotracheal intubation or mechanical ventilation or maintenance of RF> 24 ipm and saturation <90% after the administration of supplemental oxygen through a nasal catheter at 4 liters / min; Dosage of D-dimer greater than and equal to 0.5 pg / ml; Presence of prothrombin time (TP / INR) <1.5 and APTT (activated partial thromboplastin time (APTT) <1.5; Platelet count greater than 100,000 / mm3 | Exclusion criteria: Age over 85 years; creatinine clearance <10 ml / min; severe circulatory shock with a dose of norepinephrine greater than 1.0 pg / Kg / min; Chronic renal patients on hemodialysis; chronic Child B and C liver disease; advanced diseases (active neoplasia, heart failure functional class III and IV, COPD in chronic use of oxygen with more than 2 exacerbations in the last year, advanced dementia, bedridden patient with significant sequelae of stroke or traumatic brain injury; cardiorespiratory arrest; pregnant women; recent major surgery in the last 3 weeks; recent stroke in the last 3 months; presence of active bleeding; presence of blood dyscrasia such as: hemophilia, Von Willebrand factor deficiency, etc.; participation in another clinical investigation with associated intervention; formal indication for oral anticoagulation for other reasons such as: pulmonary embolism, acute coronary syndrome, etc. | covid-19
acute respiratory distress syndrome;B97.2 | Patients will be randomized in a 1: 1 ratio between two groups through a digital application.<br>Group 1) Full heparinization with enoxaparin: Full heparinization will be performed with enoxaparin adjusted for creatinine clerance according to the scheme below): 10 patients<br>Creatinine clearance <75 years> 75 years<br>> 50 ml / min 1 mg / Kg SC BID 0.75 mg / Kg SC BID<br>30-50 ml / min 0.75 mg / Kg BID 1 mg / Kg SC 1x<br>10-30 ml / min 1 mg / kg SC1x 0.75 mg / kg 1x<br><10 ml / h Will not be included Will not be included<br><br>As renal function can change during the study, we consider daily creatinine dosage necessary and the adjustment of the dose of enoxaparin should be performed daily according to the evolution of renal function. Duration of heparinization: 96 hours. Enoxaparin may be extended up to 7-10 days at the discretion of the medical team for those patients who show significant clinical improvement. Enoxaparin may be suspended at any time if any major or minor bleeding is observed according to the safety criteria included in this study or platelet count below 30,000 mm3. If, during the course, renal function worsens with creatine clearance below 10 ml / min, he should receive unfractionated heparin adjusted by APTT aiming at a ratio between 1.5 and 2.0.<br><br>Group 2) Prophylactic heparinization: 10 patients<br><br>The control group will receive prophylactic heparin with unfractionated heparin SC at a dose of 5000 IU 8/8 h or enoxaparin 40 mg SC 1 x day. In obese patients (weight> 120 kg), the dose in UFH SC may be increased to 7500 IU SC 8/8 hs and the dose of enoxaparin may be increased to 40 mg SC 12/12 h<br><br><br>Note: The full UFH arm was abandoned due to difficulties in adjusting the heparin dose in these patients requiring multiple test collection;Drug;D27.505.954.502.119 | Evaluation of gas exchange between D0 / D4 /D7 /D14 evaluated through the PO2 / FIO2 ratio; days without mechanical ventilation (within 28 days of follow-up, how many days were out of mechanical ventilation, if the patient dies before 28 days of follow-up, it is considered that he did not stay any day out of mechanical ventilation) | | | | Yes | False | | |
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| RBR-4wnx2q | 2 November 2021 | Pulmonary rehabilitation in individuals affected by Covid-19 | Evaluation, pulmonary rehabilitation and follow-up of individuals affected by Covid-19 after hospital high - treatment and clinical follow-up | | Universidade Estadual do Centro Oeste | 26/06/2020 | 20200626 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-4wnx2q | Recruiting | No | 18Y | 80Y | - | 06/06/2020 | | Intervention | 3-arm open, parallel, controlled, non-randomized clinical trial of treatment. | N/A | Brazil | Christiane | Daniel | Alameda Élio Antonio Dalla Vecchia, 838 Bairro - Vila Carli | criedi@unicentro.br | +55-042-36298100 | Universidade Estadual do Centro Oeste | Inclusion criteria: Individuals over 18 years old; diagnosis of Covid-19 confirmed and cured, With clinical stability | Exclusion criteria: Patients who do not accept to participate in the research, patients with Covid-19 still in the isolation period | Coronavirus Infections; /rehabilitation; Telemonitoring;C01.925.782.600.550.200;Q65.060;SP2.021.167.010.090.120 | Patients will be submitted to 3 intervention groups: 6-week training group (GT6): 51 participants, 8-week training group (GT8): 51 participants and call center training group (GTT): 50 participants, all with a frequency of 2 times per week and duration of 1 hour and will be reevaluated at the end of rehabilitationThe rehabilitation of post-COVID-19 patients should include:<br>a) Health education: focused on understanding diseases, the importance of maintaining healthy habits and resocialization.<br>b) Aerobic exercises: lasting 20 minutes, twice a week, using a treadmill or exercise bike with speed determined by the Borg scale.<br>c) Muscle strength exercises: in target groups: knee and hip flexors and extensors, exercises on upper limbs diagonals<br>d) Inspiratory muscle training (IMT): Started with 60% of PIMax using the powerbreath device.<br>The resistance applied to the strength and speed exercises of the treadmill and / or bicycle will be graded using the modified Borg scale, which is a descriptive marker of subjective physical effort of dyspnea and fatigue in the lower limbs. It ranges from 0 to 10, where 0 characterizes no and 10 maximum effort. The patients answered the scale and those who were under an effort degree less than 7 were submitted to resistance adjustments.<br>For the IMT, the load increase will also occur based on the perceived effort of the patients through the modified Borg scale. If the participant reached grade 7 on the modified Borg scale, the load would be increased by 5%. Two series of 30 breathing efforts will be performed with an interval of 1 minute between them.;Other;C01.925.782.600.550.200;Q65.060;SP2.021.167.010.090.120 | Improved of the strength and breathing capacity by 10% assessed through pulmonary function measurements | | | | No | False | | |
| → | RBR-5kkpg6 | 2 November 2021 | Effect of eating habits and exposure to light on sleep, emotion, memory and headache in college students during the COVID-19 pandemic | Interaction of food and light synchronization on sleep aspects, cognition and headache in college students during the COVID-19 pandemic | | Universidade Federal de Pernambuco | 28/06/2020 | 20200628 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-5kkpg6 | Not Recruiting | No | 18Y | 30Y | - | 29/06/2020 | | Intervention | Randomized controlled, parallel, three-arm, triple-blind, retrospective and prospective study. | N/A | Brazil | Mirian;Rhowena→Rhowena;Mirian | David;Matos | Rua Maurílio Silva Santos, 319, Malvinas;Rua do Alto do Reservatório s/n, Bela Vista | miriancelly@hotmail.com;rhowenajane@gmail.com | +55-083-987061522;+55-081-999271605 | Universidade Federal de Pernambuco;Universidade Federal de Pernambuco | Inclusion criteria: College students regularly enrolled in higher education institutions; both sexes, between 18 and 30 years of age; in social isolation, leaving your home only for essential activities. | Exclusion criteria: Students from colleges, originally with a distance learning method; students from international colleges. | Sleep Disorders/Circadian Rhythm, Feeding Behavior, Light, Depression, Anxiety, Fear, Psychological Stress, Memory, Headache;C10.281.800;F01.145.113.547;G01.358.500.505.650;F01.145.126.350;F01.470.132;F01.470.361;F01.145.126.990;F02.463.425.540;C23.888.592.612.441 | Participants will be randomly assigned to the following exhibitions:<br><br>- Adjusting Sleep Habits:<br>* Group type: experimental (intervention).<br>* Sample: 700 individuals.<br>* Mode of administration: videos.<br>* Sessions: 1 session per day for 20 days. <br>* Session duration: 10-20 minutes.<br>* Description: strategies for adjusting sleep habits will be presented regarding education about sleep and its main disorders; maintaining constancy in sleep times; sleep stimulus control techniques.<br><br>- Muscle Relaxation:<br>* Group type: control (comparator).<br>* Sample: 700 individuals.<br>* Mode of administration: videos.<br>* Sessions: 1 session per day for 20 days.<br>* Session duration: 10-20 minutes.<br>* Description: Isometric muscle contraction of body segments (hands, arms, neck, face, abdomen, thighs, legs, feet) will be requested for 10-15s (one segment at a time), followed by the relaxation of such segment in 15- 20s.<br><br>- Association of both exhibitions:<br>* Group type: control (comparator).<br>* Sample: 700 individuals.<br>* Mode of administration: videos.<br>* Sessions: 1 session per day for 20 days.<br>* Session length: 20 minutes.<br>* Description: There will be an association of the exposures previously reported.;Behavioural;F01.145.488.725;G11.427.494.554 | Outcome 1: More robust rhythm of the activity-rest rhythm in the experimental group compared to the control evaluated through actimetry and levels of salivary cortisol and melatonin, considering a better rhythm the more the parameters follow a cosinor curve.;Outcome 2: Improvement in sleep quality in the experimental group compared to control assessed using the Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale, in which the higher the scores, the worse the subjective sleep quality and sleepiness, respectively.;Outcome 3: More robust rhythmicity of exposure to light in the experimental group compared to the control evaluated through actimetry, considering a better rhythmicity the more the parameters follow a cosinor curve.;Outcome 4: More robust rhythmicity of the feeding times in the experimental group compared to the control evaluated through a diary, considering a better rhythmicity the more the feeding times follow a cosinor curve.;Outcome 5: Improvement in anxious, depressive, stress and fear symptoms in the experimental group compared to control, assessed through the Trait-State Anxiety Inventory, Beck's Depression Inventory, Perceived Stress Scale - 10 and Fear Questionnaire, respectively; in which the lower the scores, the lower the intensity of the aforementioned emotional symptoms.;Outcome 6: Best visuospatial and verbal memory in the experimental group compared to control, assessed using the Rey Osterrieth Complex Figure Test and Rey Auditory-Verbal Learning Test, respectively; in which the higher the scores, the better the individuals' memory.;Outcome 7: Lower headache incidence in the experimental group compared to the control assessed through the diary, so that the fewer days with headache, the lower its incidence. | | | | Yes | False | | |
| RBR-7jqpnw | 2 November 2021 | Effect of COVID-19 convalescent plasma produced by HEMOPE: A randomized study, with a comparative group in several centers | Therapeutic effectiveness of COVID-19 convalescent plasma produced by HEMOPE: a multicenter, randomized and controlled clinical trial - PLAVID-TRIAL: Covid convalescent plasma - Clinical Trial | | Universidade de Pernambuco | 29/06/2020 | 20200629 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-7jqpnw | Not Recruiting | No | 18Y | | - | 01/07/2020 | | Intervention | Clinical trial of treatment, randomized, open, with two arms | 3 | Brazil | Demócrito | Miranda Filho | Rua Arnóbio Marques, 310, Santo Amaro | demofilho@gmail.com | +55 081 999764712 | Universidade de Pernambuco | Inclusion criteria: adults> 18 years with diagnosis of COVID – 19, who are hospitalized; and considered as having a condition that increases the risk of a worse prognosis: obesity; diabetes mellitus (DM); systemic arterial hypertension (SAH); chronic lung disease, obesity, diseases that alter immunity (AIDS, neoplasms or autoimmune diseases in immunosuppressive therapy, chronic liver disease. | Exclusion criteria: History of anaphylactic reaction related to blood transfusion. | Diabetes Mellitus; Hypertension; Lung Diseases; Respiratory Insufficiency; Respiration, Artificial; Critical Care; Hospitalization;C18.452.394.750;C14.907.489;C08.381;C08.618.846;E02.041.625;E02.760.190;E02.760.400 | Experimental group: convalescent plasma + local standard of care for Covid-19 (110 participants). Control group: local standard of care for Covid-19 (110 participants);Biological/vaccine;A12.207.152.693;D12.776.124.486.485.114;E02.120.770;B04.820.504.540.150.113;C01.748.730 | It is expected to find a 50% reduction in the frequency of lethality in the intervention group when compared to the control group | | | | Yes | False | | |
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| RBR-7jrxqm | 2 November 2021 | Effect of a special nutritional oral supplement use on inflammation in patients with COVID-19 | Effect of oral supplement use with immunonutrients on inflammatory response in patients with COVID-19
| | Universidade do Estado da Bahia | 10/07/2020 | 20200710 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-7jrxqm | Recruiting | No | 18Y | 65Y | - | 01/06/2020 | | Intervention | Randomized, double-blind, parallel, two-arm treatment trial | N/A | Brazil | Rodrigo;RODRIGO | Pimentel;PIMENTEL | Rua Augusto Viana;Rua Augusto Viana, SN | rodrigo.pimentel@ebserh.gov.br;rodrigo.pimentel@ebserh.gov.br | +5571981877218;71 981877218 | Complexo Hospitalar Professor Edgard Santos;UNIVERSIDADE DO ESTADO DA BAHIA | Inclusion criteria: Patients with the following criteria will be included: adults aged between 18 and 65 years, diagnosed with Covid-19 by molecular examination (RT-PCR), with pervious gastrointestinal tract, using oral diet and who are not on mechanical ventilation or requiring icu admission. | Exclusion criteria: Pregnant patients; who have undergone the use of artificial nutrition in the 15 days prior to inclusion in this study; patients allergic to any components of the diets used; with severe hyperglycemia(greater than 180mg/dl) or hypertriglyceridemia (greater than 400mg/dl); with previous gastrointestinal diseases (surgical resections, malabsorption syndromes, inflammatory bowel diseases, persistent paralytic ileus, upper gastrointestinal bleeding or severe acute pancreatitis); with neutropenia-defined immunosuppression states, myelodysplastic syndromes, congenital immunodeficiency, or Acquired Immunodeficiency Syndrome (AIDS), immunosuppressive therapies in the last 03 months, systemic chemotherapy in the last 03 months, autologous bone marrow transplantation in the last year, halogenic bone marrow transplantation in the last 02 years, or existence of graft versus host disease (DEVH); with advanced chronic diseases (Child-Pugh stage C, grade IV heart failure (NYHA), chronic functional stage lung failure IV, terminal degenerative neurological processes, neoplasms in remission or progression over treatment); with processes with short life expectancy including end-stage chronic kidney disease; with acute processes that determine small survival as shock of any etiology with multiple organ dysfunction refractory to therapy in the first 48h or post-resuscitation severe neurological damage within 72 hours will be excluded | Coronavirus Infections; Nutrition Therapy; Inflammation;C01.925.782.600.550.200;E02.642;C23.550.470 | Fifty patients will be randomized to receive either standard hyperprotein normcaloric supplement (control - 25 participants) or immunonutrient-enriched supplement (experiment - 25 participants) at a ratio of 1:1 for a period of 07 days. Supplements will be blinded to patients. Researchers will not know which supplement each patient will use until the end of the study. <br>The control supplement will provide, for every 100ml, 120kcal, 6.5g of protein, without adding any immunonutrition component (Nutren Senior®, Nestlé). The immunomodulatory supplement will offer, every 100ml, 109kcal, 6.5g of protein, with the addition of L-arginine, nucleotides and fatty acids omega-3 (Impact®, Nestlé). Both will receive 200ml of supplementation daily. <br>Administration of the supplement will occur 02 times a day, initiated immediately after inclusion of the patient in the study, and will be maintained for 07 days. The drug treatment of the underlying pathology will follow the institutional protocol<br>;Dietary supplement;G07.203.300.456 | We will observe the reduction of serum levels of inflammatory markers (C-Reactive Protein, IL6 and TNF-) in patients infected with Covid-19 through serum biochemical dosage from the finding of at least 30% difference between groups. | | | | No | False | | |
| → | RBR-6xqcr4 | 2 November 2021 | Assessment cardiorespiratory in recovered Covid-19 patients | Cardiorespiratory fitness and neuromuscular performance in recovered Covid-19 patients - CPET: Cardiopulmonary Exercise Test | | LETFAS-UFPB | 10/07/2020 | 20200710 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-6xqcr4 | Recruiting | No | 18Y | 59Y | - | 01/07/2020 | | Observational | Prospective observational analytical case-control study | N/A | Brazil | Amilton;Maria do Socorro→Maria do Socorro;Amilton | Santos;Brasileiro-Santos | Department of Physical Education Cidade Universitária - João Pessoa - Paraíba - Brazil.;Department of Physical Education Cidade Universitária - João Pessoa - Paraíba - Brasil. | adagatom@yahoo.com.br;sbrasileiro@yahoo.com.br | +55 83 99352-3994;+55 83 98202-7067 | LETFAS-UFPB;LETFAS-UFPB | Inclusion criteria: Patients recovered from Covid-19 with mild to severe severity (recovery within 30 days) and people not contaminated by the coronavirus; both sexes; non smokers; 18 years old or older | Exclusion criteria: Smoking volunteers; pregnancy; morbid obesity; diagnoses of cardiac, pulmonary, hematological, neurological or neuromuscular diseases | Coronavirus Infections;C01.925.782.600.550.200 | Experimental group: 80 patients recovered from COVID 19 will undergo a cardiopulmonary exercise test on a cycle ergometer (ramp protocol) to assess cardiorespiratory capacity, and the electrical activity of the vastus lateralis muscle will be measured with surface electromyography to assess neuromuscular efficiency .<br><br>Control group: 70 people not affected by the disease caused by the coronavirus, will be submitted to the cardiopulmonary exercise test on a cycle ergometer (ramp protocol) to assess the cardiorespiratory capacity, and the electrical activity of the vastus lateralis muscle will be measured with surface electromyography, for assess neuromuscular efficiency.;Dietary supplement;Other;G11.427.680.270;E01.370.405.255;G03.680 | Presentation of the expected outcome: To assess the maximum oxygen uptake [VO2max] in patients recovered from COVID 19 and healthy individuals.<br>Patients recovered from COVID 19, with severe severity, are expected to have lower VO2max compared to patients recovered from COVID 19 who had mild symptoms or with healthy individuals (not infected by the coronavirus).<br>VO2max will be obtained in the cardiopulmonary exercise test [CPET], using the ramp protocol on a cycle ergometer.<br>VO2max will be presented in absolute values (L min) and in% predicted values.;Presentation of the expected outcome: To assess neuromuscular efficiency [relationship between workload variation with the percentage of muscle activation] in patients recovered from COVID 19 and healthy individuals.<br><br>Patients recovered from COVID 19, with severe symptoms, are expected to have lower neuromuscular efficiency compared to patients recovered from COVID 19, who had mild symptoms or with healthy individuals (not infected by coronavirus).<br><br>The variation of workloads will be evaluated during the cardiopulmonary exercise test [25, 50, 75 and 100 watts]<br>The percentage of muscle activation will be obtained by surface electromyography of the vastus lateralis muscle and will be presented in %RMS. | | | | No | False | | |
| RBR-45kf9p | 2 November 2021 | CoV-Hep study : Comparative study between different anti-coagulation strategies in continuous hemodialysis in COVID-19 patients | CoV-Hep study: Randomized and paired clinical trial comparing regional anticoagulation modalities in continuous venous venous hemodialysis in patients with COVID-19 | | Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo | 13/07/2020 | 20200713 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-45kf9p | Recruiting | No | 18Y | | - | 29/06/2020 | | Intervention | Clinical trial of treatment, randomized-controlled, parallel, open, with two arms | N/A | Brazil | Camila;Paulo | Eleuterio Rodrigues;Gessolo Lins | Dr. Enéas Carvalho de Aguiar, 255 - 7o andar - Nefrologia;Rua Dr. Enéas Carvalho de Aguiar, 255 - 7o andar - Nefrologia | camila.eleuterio@hc.fm.usp.br;paulo.lins@hc.fm.usp.br | +5511945428122;+5511982792696 | Hospital das Clínicas da FMUSP;Hospital das Clínicas da FMUSP | Inclusion criteria: Men and women aged 18 and over;
<br>
<br>Confirmed or probable SARS-CoV-2 infection;
<br>
<br>Presence of acute kidney injury with indication and agreement between ICU and nephrology teams for the introduction of renal continuous venous venous hemodialysis. | Exclusion criteria: Hypersensitivity to any of the substances used in the study (Citric acid dextrosol 2.2% and unfractionated heparin);
<br>
<br>Previous diagnosis of coagulopathy or thrombophilia;
<br>
<br>Contraindication to the use of unfractionated heparin by the assistant team;
<br>
<br>Risk of citrate poisoning - (Lactate> 30mg / dL, IRN> 2.5, Total bilirubin> 15mg / dL);
<br>
<br>Pregnancy | Acute Kidney Injury
Severe COVID-19;C12.777.419.780.050;C01.925.782.600.550.200 | After randomization, patients will be allocated to one of two groups:<br><br>Control group (n = 45): patients on continuous hemodialysis (blood flow 150 ml / min, dose of 30 ml / kg / h) receiving anticoagulation with sodium citrate at 4 mmol / l. The dialysis system pressures, dialyzer patency and duration and bleeding rate will be assessed for 72 hours;<br><br>Intervention group (n = 45): patients on continuous hemodialysis (blood flow 150 ml / min, dose of 30 ml / kg / h) receiving anticoagulation with sodium citrate at 4 mmol / l associated with unfractionated heparin at 10U / Kg / h. The dialysis system pressures, dialyzer patency and duration and bleeding rate will be assessed for 72 hours.;Drug;D09.698.373.400;D02.241.081.901.434.249.875;E02.870.150 | The percentage of clotted dialyzers within 72 hours in each of the studied groups.<br>Anticoagulation with citrate + heparin is expected to lead to a lower percentage of clotted dialyzers than anticoagulation with citrate alone, in 72 hours of therapy. | | | | No | False | | |
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| RBR-7dsxsv | 2 November 2021 | Software to evaluate clinical, epidemiological data and chest computed tomography to predict which patients with COVID-19 will develop a severe form of the disease. | Machine Learning model to predict the prognosis and severity by computed tomography and clinical-epidemiological correlation in COVID-19 patients. | | Diagnósticos da América Sociedade Anônima (DASA) | 04/08/2020 | 20200804 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-7dsxsv | Recruiting | No | | | - | 02/03/2020 | | Observational | A retrospective, observational, analytical case-control study. | N/A | Brazil | Felipe | Kitamura | Rua Gilberto Sabino, 215, 3o andar, dasainova | kitamura.felipe@gmail.com | +5511979630032 | Dasa | Inclusion criteria: Signs and symptoms of acute respiratory syndrome. Positive epidemiological history for COVID-19, which may include recent contact (last 14 days) with a confirmed or suspected case, recent trip (last 14 days) to a high-incidence location, or presentation of symptoms after the start of the community transmission phase of SARS-CoV-2 (after 20/03/2020) when the date of hospitalization. Have performed, when symptomatic, a chest computed tomography.
<br> | Exclusion criteria: Presence of neoplastic (primary or metastatic) lung lesions, manifested as nodules, masses, consolidations, septal thickening (lymphatic carcinomatosis) or pleural thickening. Chest computed tomography with the presence of movement, acquisition or reconstruction artifacts that make it impossible to apply the segmentation algorithms. Computed tomography exams with low quality pulmonary segmentation, or cut slice thickness greater than 3.0 mm. | Coronavirus infection, unspecified. Shock, unspecified. Septicaemia, unspecified. Adult respiratory distress syndrome. Acute renal failure;B34.2;R57.9;A41.9 | A group of 500 hospitalized patients suspected of having COVID-19 will be monitored for clinical, laboratory and imaging data (chest tomography) throughout their hospitalization, until discharge or death occurs or the follow-up time exceeds 2 months, in order to create a database for the development of an outcome prediction algorithm.;Other;R76.9 | 4) Development of Acute Respiratory Discomfort Syndrome: defined as Acute respiratory failure with acute bilateral opacities on radiographys or CT not fully attributable to pleural effusions, pulmonary congestion, atelectasis or nodules, within one week after installation the triggering injury and, when signs suggestive of edema are present, may not be completely attributable to cardiac dysfunction or fluid overload.;3) Orotracheal intubation due to acute respiratory failure.<br>;2) Length of stay in the ICU (ICU LOS), defined as the period (in days) elapsed between admission and discharge (or death) from the ICU.<br>;1) Time to hospital discharge (length of stay, LOS), defined as the period (in days) between the date of admission and the date of discharge (or death). | | | | No | False | | |
| → | RBR-35734p | 2 November 2021 | Treatment of severe COVID-19 with angiotensin-(1-7) | Randomized clinical trial phase I/II for the use of angiotensin-(1-7) in the treatment of severe infection by Sara-CoV-2 | | Angitec | 05/08/2020 | 20200805 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-35734p | Recruiting | Yes | 17Y | 81Y | - | 05/08/2020 | | Intervention | Clinical trial of treatment, randomised- controlled, parallel, double blinded, with two arms | 1-2 | Brazil | Ana Luiza;Robson→Robson;Ana Luiza | Valle;Santos | Avenida Antonio Carlos, 6627;Avenida Picadilly, 150 sala 215 | anavalle9@icloud.com;santos@icb.ufmg.br | +55(31)97654162;+55(31)987762956 | Universidade Federal de Minas Gerais;Angitec | Inclusion criteria: Age: less than 17 and less or equal to 81 years; Admission to the Intensive Care Unit with severe pneumonia criteria (clinical signs of pneumonia + one of the following criteria: respiratory rate greater than 30 irpm; signs of respiratory effort, SatO2 less than 90% in room air); COVID-19 confirmed or highly suspicious (positive contact or suggestive image) | Exclusion criteria: Patients diagnosed with cancer (at any stage); Hemodynamic instability (need for vasopressors); Pregnant women; Immunocompromised patients; Exclusive Palliative Care; Inclusion in any other interventionist study; Heart failure as a predominant cause of acute respiratory failure; decompensated liver cirrhosis; HIV +; Dialysis; Home / long-term oxygen therapy; Idiopathic pulmonary fibrosis | Severe Infection with Sara-CoV-2;C01.925.782.600.550.200 | initially, 30 patients with severe Covid-19 grade will be treated with intravenous administration of angiotensin- (1-7) for up to 7 days to assess the safety of this treatment (Phase I).<br>If this step provides positive data, the second phase (Phase 2) will start. Patients with severe Covid -19 form will be divided into two groups. The experimental group (N = 50) had received intravenous angiotensin- (1-7) for up to 7 days. The second group will be treated with placebo, for the same period.<br>Patients will be followed for up to 28 days.;Biological/vaccine;Other;D06.472.699.094 | Primary outcome: the primary outcome of the study will be the supplemental oxygen-free days (SOFDs) at 28 days., defined as SOFDs = 28 - x, where x = number of days on which the patient is released from supplemental oxygen therapy after start. | | | | Yes | True | parent | |
| RBR-564y4n | 2 November 2021 | Evaluation of muscle weakness, function and quality of life after Intensive Care Unit discharge in survivors of COVID-19 | Investigation of muscle weakness, function and quality of life after Intensive Care Unit discharge in survivors of COVID-19 | | Instituto de Assistência Médica ao Servidor Público Estadual | 06/08/2020 | 20200806 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-564y4n | Recruiting | No | 18Y | | - | 20/05/2020 | | Observational | Observational cross-sectional study | N/A | Brazil | Lucas | Arrebola | Av. Ibirapuera, 981 | lucasarrebola@gmail.com | +55 11-45738000 | Instituto de Assistência Médica ao Servidor Público Estadual | Inclusion criteria: Both sexes; aged 18 years and above; confirmed diagnosis of COVID-19; treatment with invasive mechanical ventilation; survivors during the hospitalization period, and discharge from the ICU. | Exclusion criteria: Primary cause of using invasive mechanical ventilation is not pneumonia caused by COVID-19; not be subjected to invasive mechanical ventilation; death during the ICU stay; inability to understand verbal commands and altered level of consciousness. | Coronavirus infection, unspecified
Coronavirus as the cause of diseases classified to other chapters;B34.2;B97.2 | 90 patients with confirmed diagnosis of covid-19 who were discharged from the Intensive Care Unit (ICU) will be assessed.<br><br>Assessments: The assessments will be carried out during the patients' hospitalization, at least 48 hours after discharge from the ICU. <br><br>The assessments will be as follow:<br><br>- Demographic and medical data: the patients' demographic data, pre-existing comorbidities, complications in the hospitalization period, the severity of the disease using the Acute Physiology and Chronic Health Evaluation scale, organ failure through the Sequential Organ Failure Assessment, the period of using invasive mechanical ventilation, the duration of symptoms until admission in the ICU, the extubation failures, the severity of ARDS, laboratory tests on the date of admission and discharge from the ICU, the oxygenation index on the date of admission to the ICU, the worst oxygenation index at the time of hospitalization and the chest CT scan in order to determine the patients' lung compliance profile.<br><br>- Muscle strength: Muscle strength will be assessed using the Medical Research Council (MRC) scale and using handgrip dynamometry.<br><br>- Barthel Index (IB): it will be used retrospectively and at the time of assessment to ascertain the patients' functional independence previously and at the time of hospitalization.<br><br>- Functional State Scale in the Intensive Care Unit (FSS-ICU): will be used to assess the participants' independence related to transfers, including rolling, transferring to sitting, transferring from sitting to standing, sitting on the edge of the bed and walking.<br><br>- Euro Quality of Life Instrument 5D (EQ5D): will be used to assess the participants' quality of life.<br><br>- Clinical Frailty Scale: will be used to class;Other;SP1.011.122 | The primary outcome of this study will be the prevalence of intensive care unit acquired muscle weakness in survivors of COVID-19, assessed using the Medical Research Council scale. | | | | No | False | | |
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| RBR-63hzd3 | 2 November 2021 | Consequences of COVID-19 in dialytic patients | Prospective study of COVID-19 in dialytic patients - VIDA: prospective study of coVId-19 in Dialytic pAtients | | Associação Evangélica Beneficente de Minas Gerais | 06/10/2020 | 20201006 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-63hzd3 | Recruiting | No | 18Y | | - | 01/05/2020 | | Observational | Observational, retrospective and prospective cohort. | N/A | Brazil | Gabriel | Carmo | Rua Dr. Alípio Goulart, nº 25, Bairro Serra | cep@aebmg.org.br | +55-31-21388371 | Associação Evangélica Beneficente de Minas Gerais | Inclusion criteria: Dialytic patients from Centros de Nefrologia do Hospital Evangélico de Belo Horizonte; patients with diagnosis of COVID-19 admited in Hospital Evangélico de Belo Horizonte, older than 18 years old. | Exclusion criteria: Refuse to sign the informed consent form, patients younger than 18 years old and vulnerable populations. | COVID-19; chronic renal insufficiency; dialysis; Renal Dialysis; Respiratory Insufficiency; Hypoxia;E02.870.300;C23.888.852.079;C08.618.846 | This is a retrospective cohort study (for patients who have already had the disease) and prospective, conducted at Hospital Evangélico de Belo Horizonte. Dialitic patients over 18 years of age, regardless of color or sex, will be included sequentially after signing the informed consent form (ICF). Such individuals will be followed during dialysis sessions to check for the presence of symptoms compatible with COVID-19. Patients who develop the disease will be part of group 1, as explained below. Those who do not develop will be considered group 2 and will be part of a control group. Non-dialitic patients admitted to Hospital Evangélico de Belo Horizonte will also be included and will be part of another control arm (group 3).<br><br>Secondary demographic data will be collected such as sex, age, date of birth, color, weight and height. Then, information regarding the previous diseases will be collected, such as the presence of systemic arterial hypertension, diabetes mellitus, heart failure, exposure to tobacco, previous surgeries and use of medications. Subsequently, we will evaluate clinical data on patient admission such as heart rate, blood pressure, temperature, oxygen saturation and the presence of COVID-19-related symptoms such as cough, sore throat, shortness of breath, fever, etc. Such characteristics are considered “Exposure Variables” and will correlate to the “Outcome Variables” described below:<br><br>•Laboratory tests, electrocardiogram, echocardiogram, radiographs, ultrasounds, computed tomography and magnetic resonance;<br>•Oxygen administration and which form was used, use of medications, mode of mechanical ventilation, indication of prone position, etc.<br>• Outcomes such as mortality, presence of cardiovascular events (such as acute myocardial infarction;Other;G03.820 | Total death and acute respiratory failure: Type 1 acute respiratory failure is defined when paO2 is less 60mmHg; type 2 acute respiratory failure is defined when paCO2 greater than 50mmHg and arterial pH is less than 7.35; mixed acute respiratory failure is defined when paO2 is less than 60mmHg and paCO2 is greater 50mmHg. | | | | No | False | | |
| → | RBR-825p57 | 2 November 2021 | Telerehabilitation for elderly people with Alzheimer's disease and their caregivers | Telerehabilitation as an alternative to COVID-19 pandemic and its effects on functional capacity, mental health and quality of life of older people with Alzheimer's disease: a randomized and controlled clinical trial | | Universidade Federal de São Carlos | 08/10/2020 | 20201008 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-825p57 | Recruiting | No | 60Y | 100Y | - | 20/09/2020 | | Intervention | Clinical treatment trial, randomized-controlled, parallel, single-blind, with two arms | N/A | Brazil | Carla;Carolina→Carolina;Carla | Andreatto;Tsen | Rodovia Lauri Simões de Barros, km 12; | psicologa.andreatto@gmail.com;carolina.tsen@estudante.ufscar.br | +55 19 98265-4636;+5545999604522 | Universidade Federal de São Carlos;Universidade Federal de São Carlos | Inclusion criteria: The study will include elderly people diagnosed with AD, attested by the neurologist or psychiatrist who monitors the patient; caregivers and / or family members who spend most of the day with the elderly with AD - who live with the elderly for at least half of the day, four times a week, mandatorily; any member who lives in the house and who is familiar with cell phones that have video calling applications to enable the proposed assessments and intervention; Elderly who are in the mild and moderate stages of the disease, assessed by the Clinical Dementia Assessment Score (CDR). | Exclusion criteria: As there is an intention to treat all volunteers, the elderly and caregivers who do not have indications for physical activity performed at home will be excluded, attesting their physical fitness by the doctor they trust; older people who perform systematic physical exercise with professional monitoring that can interfere with the results; history of serious muscle injuries, motor deficit due to neuromuscular disease; motor or cognitive sequelae due to stroke, associated neurological diseases that impair cognition and mobility, such as Parkinson's disease, Multiple Sclerosis, Huntington's disease, epilepsy and traumatic brain injury; any functional or sensory impairment that prevents the application of the proposed tests (plegia or limb paresis, major tremor and functional impairment in the hands, severe and uncorrected audiovisual disorder that makes communication difficult during the tests); other types of dementia diagnosed; individuals with AD in the advanced stage; uncontrolled heart disease, any cardiovascular or infectious disease present in the list of absolute contraindications described in the Physical Activity Readiness Medical Examination (2002) (acute infectious disease, dissecting aortic aneurysm, severe aortic stenosis, congestive heart failure, unstable angina, acute myocardial infarction myocardium, acute myocarditis, acute pulmonary or systemic embolism, thrombophlebitis, ventricular tachycardia and other dangerous arrhythmias) or any other medical restriction that makes it impossible to participate in the present study; illiterate caregivers who are unable to read the guidelines and information in the support materials and caregivers who have the internet signal from the mobile device compromised for the proper progress of the evaluations and monitoring of the study. | quality of life, Alzheimer's disease | This is a clinical trial in which 48 caregivers and older people with AD (level and moderate stage) may come to answer a structured questionnaire on social distance and taken regarding functional capacity, mental health and quality of life. The volunteers will be randomized and divided into two groups: Telerehabilitation and Control. The telerehabilitation group will receive cognitive and multicomponent motor exercises at home, with one week of familiarization and 12 weeks of intervention through telerehabilitation, three times a week. The control group will receive an educational booklet containing guidelines for the older people to perform at home. Both groups will receive psychoeducation prior to the intervention. Participants will be accepted pre, immediately after the intervention and with a three-month follow-up.;Other;SP9.020.010.005.010.040;E02.760.169.063.500.891 | Functionality is the most important main outcome. It will be evaluated by the Activities of Daily Living Questionnaire (ADLQ), World Health Organization Disability Assessment Schedule (WHODAS 2.0), Short Physical Performance Battery (SPPB) and Direct Assessment of Functional Status (DAFS). The Intervention Group is expected to have greater functionality when compared to the Control Group after the intervention. | | | | No | False | | |
| RBR-4nr86m | 2 November 2021 | Effects of Nitazoxanide Administration to Patients in the Initial Phase of COVID-19 | Effects of Early Use of Nitazoxanide in Patients with COVID-19 | | Universidade Federal do Rio de Janeiro-UFRJ | 24/08/2020 | 20200824 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-4nr86m | Recruiting | Yes | | | - | 08/06/2020 | | Intervention | Randomized, placebo-controlled, paralell, double-blinded, interventional, treatment clinical trial with two arms. | 2 | Brazil | Patricia | Rocco | Avenida Carlos Chagas Filho 373 sala C1-045 | prmrocco@biof.ufrj.br | +55-021-39386530 | Universidade Federal do Rio de Janeiro-UFRJ | Inclusion criteria: Will be included in the study of patients of both genders who meet all of the following requirements: clinical scenario compatible with infection by the SARS-CoV-2 [Characteristic symptoms of COVID-19 (fever and / or drought and / or fatigue), beginning 1 to 3 days before inclusion in the study; age equal or superior to 18 years; willingness to receive study treatment; providing written and informed consent or the same consent signed by a family member. | Exclusion criteria: Individuals who meet at least one of the following criteria will be excluded from the study: negative result of RT-PCR for SARS-COV2 collected on admission; impossibility to use oral medications; history of severe liver disease (Child Pugh C class); previous renal failure: patients undergoing dialysis; severe heart failure (NYHA 3 or 4); COPD (GOLD 3 and 4); neoplasia in the last 5 years; known autoimmune disease; individuals with known hypersensitivity to study drugs; previous treatment with the study medication during the last 30 days; clinical suspicion of tuberculosis and bacterial pneumonia. |
Coronavirus infection, unspecified / COVID-19;B34.2 | Patients diagnosed with COVID-19 will be randomly divided into 2 groups: experimental and control groups.<br>Experimental group: 196 patients diagnosed with COVID-19 confirmed by RT-PCR will receive nitazoxanide 500mg 8/8 hs for 5 days. Control group: 196 patients diagnosed with COVID-19 confirmed by RT-PCR will receiveplacebo 8/8 hs for 5 days.;Drug;E02.319.307.500 | Reduction in the duration of fatigue of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.<br>;Reduction in the duration of cough of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.<br>;Reduction in the duration of fever of patients with COVID-19 submitted to the therapeutic protocol with nitazoxanide compared to patients treated with placebo; verified through the collection of information with the patient; quantified by the number of days that presented the symptom.<br> | | | | No | True | parent | |
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| RBR-8x8g36 | 2 November 2021 | Effectiveness of a mouthwash and toothpaste containing PHTALOX in controlling symptoms of COVID-19 and flu | Efficacy of mouthwash and toothpaste containing PHTALOX in the clinical control of COVID-19 and Flu Syndrome: a randomized triple-blind clinical tria | | Instituto Federal do Paraná | 29/10/2020 | 20201029 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-8x8g36 | Not Recruiting | No | 18Y | 70Y | - | 01/11/2020 | | Intervention | Clinical safety / efficacy trial, randomized, parallel, with triple concealment, with two arms, phase 3 | 3 | Brazil | Marcelo | Poleti | Rua João XXIII, 600 | marcelo_poleti@yahoo.com.br | +55-43-38786101 | Instituto Federal do Paraná | Inclusion criteria: Adult individuals (> 18 years old), of both sexes, from the city of Londrina with clinical suspicion of COVID-19, submitted to testing through RT-PCR at the Sabará-Londrina Emergency Care Unit (UPA), who have no contraindications to perform mouthwash / gargle and have access to the cell phone with communication application (WhatsApp). | Exclusion criteria: Patients who do not present clinical conditions, during the research, to perform mouthwashes / gargles daily, who did not tolerate the use of the products, who are hospitalized for treatment of the disease or give up participating in the research. | Covid-19, Human Influenza;D018352;D007251 | The project has two groups, namely:<br>a) Experimental group (n = 250): each participant will receive a Kit for oral care containing toothbrush and dental floss + mouthwash and dental gel containing PHTALOX. Participants will be instructed on how to use the products through a folder and digital content. For 14 consecutive days, participants will brush their teeth 3 times a day and rinse / gargle with 5 ml of mouthwash, for 1 minute, 5 times a day using only the material provided. They will be instructed not to use any other oral hygiene products during the research period.<br>b) Control group (n = 250): each participant will receive a Kit for oral care containing a brush and dental floss + mouthwash and dental gel without PHTALOX. Participants will be instructed on how to use the products through a folder and digital content. For 14 consecutive days, participants will brush their teeth 3 times a day and rinse / gargle with 5 ml of mouthwash, for 1 minute, 5 times a day using only the material provided. They will be instructed not to use any other oral hygiene products during the research period.;Other;B97.2;D018352 | Improvement of clinical symptoms in the period of 14 days, verified through the self-administered questionnaire with a reduction of at least 30% of respiratory symptoms. | | | | Yes | False | | |
| → | RBR-5d7hkv | 2 November 2021 | Effect of Moderate Physical Training on a bicycle associated with altitude simulation on the health status of people recovered from COVID-19 (AEROBI-COVID) | Effect of Moderate-Intensity Training associated with normobaric hypoxia on lung function, hematological, immunological, autonomic parameters and related to physical fitness in convalescent people from COVID-19 (AEROBI - COVID) | | Escola de Educação Física e Esporte de Ribeirão Preto | 03/11/2020 | 20201103 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-5d7hkv | Recruiting | No | 30Y | 69Y | - | 11/09/2020 | | Intervention | A clinical trial of treatment, prospective, randomized-controlled, parallel, double-blind, with three arms | N/A | Brazil | Atila | Trapé | Avenida Bandeirantes, 3900 | atrape@usp.br | +551633150529 | Escola de Educação Física e Esporte de Ribeirão Preto | Inclusion criteria: Participants women and men aged between 30 and 69 years convalescent from COVID-19 (having the test with a positive diagnosis); having moderate to severe symptoms; approximately 30 days since recovery from clinical signs or medical discharge (if you have been hospitalized); have previous experience in aerobic physical activity. | Exclusion criteria: Exposure to high places (altitude greater than 1500 m) in the last three months; significant physical limitations to carry out evaluations and intervention; acute or chronic clinical illnesses without medical supervision; anemia; use of immunosuppressive drugs; pregnant women; hormone replacement; smokers; excessive use of alcohol or drugs. | Coronavirus Infections; Respiratory Function Tests; Immunologic Factors; Cardiorespiratory Fitness; Physical Fitness; Hypoxia-Inducible Factor 1, alpha Subunit;31543;12550;7336;56777;28453 ;50949 | The activities will start after signing the informed consent form approved by the Research Ethics Committee. All care for the safety of the participants and the work team will be taken. First, an evaluation of the health status will be carried out. The participants who do not have limitations or discomfort that may prevent the evaluations or the intervention's performance will participate in the proposed intervention.<br><br>The study design is based on a randomized controlled clinical trial composed of four groups, the control group being formed by the participants who are not available to participate in the intervention and accept to carry out a follow-up through the evaluations; and the physical training groups randomly divided according to the association of training (T) and recovery (R) with hypoxia (H) or normoxia (N): a) TH + RH, b) TN + RH, c) TN + RN. Each group will have 20 participants. The invitation will be made to Health Institutions in the region, offering the possibility of participation in this research to patients who have had moderate to severe symptoms approximately 30 days after the recovery of clinical signs or medical discharge (for those who were hospitalized). The disclosure will happen through the local television channels, USP Radio and News, social media, among other communication vehicles.<br><br>The experimental protocol will consist of: i) familiarization and carrying out the initial assessments (evaluation 1) in the three sessions of week 0, ii) 8-week intervention with a partial assessment to adjust the training load between weeks 4 and 5 (half of the intervention - evaluation 2), iii) reassessments at week 9, following the end of the intervention (evaluation 3), iv) reassessments at week 13, four after the end of the intervention (eval;Other;23631 | For all primary and secondary outcomes, parameters will be presented in absolute numbers and the pre and post-intervention comparisons in percentages (delta). When necessary, categories will be used to express the results.<br><br>Improvements in lung function<br><br>For pulmonary function evaluation, a portable spirometer (Micro Medical, Rochester, United Kingdom) will be used, following the current standards46 and guidelines for pulmonary function tests. Participants will be instructed to perform the maneuvers to assess forced vital capacity (FVC) and forced expiratory volume (FEV).;Improvements in autonomic parameters<br><br>HR variability will be analyzed by acquisition at each beat to determine RR intervals and analyze autonomic variables. These responses will be subjected to digital filtering performed by the device's software (Polar Precision Performance, version 3.0) by identifying and correcting some ectopic beats (irregularities in heart rhythm), involving extrasystole and consecutive compensatory pause. The analysis of HR variability will be performed by linear methods, analyzed in the domains of time (SDNN and RMSSD) and frequency (LF, HF, and LF/HF ratio). The spectral analysis will be calculated using the Fast Fourier Transform algorithm.;Improvements in inflammatory mediators and hematological parameters<br><br>Dosage of inflammatory soluble protein mediators<br>The quantification of cytokines IL-6, IL-8, IL-10, and TNF-alpha will be performed by the ELISA - Multiplex method (R&D Systems, Billings, USA).<br><br>Inflammatory lipid mediators<br>The profiles of eicosanoids and endocannabinoids will be evaluated in plasma by mass spectrometry in samples collected with EDTA anticoagulant at the facility available from FCFRP - USP. The standard protocol with solid-phase extraction (SPE) and the identification and quantification of eicosanoids and endocannabinoids will be used. Data acquisition and processing will be performed using PeakViewTM and MultiQuantTM software (Sciex, Foster, CA, USA) (Sorgi CA, et al, Scientific Data, 2018).<br><br>Hematological parameters<br>Hemogram parameters, such as total erythrocyte count, hematocrit, hemoglobin concentration, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, total leukocyte, platelet, and reticulocyte count will be evaluated. Total cholesterol, triglycerides, HDL-c, LDL-c, lactic dehydrogenase, and liver enzymes (TGO and TGP) will also be analyzed. The collection will be carried out at EEFERP by a trained and specialized professional. Later, the samples will be sent for analysis at the Clinical Analysis Laboratory of FCFRP - USP, according to the technical service's standard routine and methodology. To determine the EPO concentration in the plasma samples, the EPO Immunoassay ELISA Kit will be used.<br><br>;Improvements in maximum aerobic power (VO2max) and anaerobic threshold (AT) <br><br>An incremental test will be used to estimate AT, VO2max, and iVO2max. The warm-up will be 5 min in cycle ergometer (E200, COSMED, Italy) without load (0 Kp). At each 2-minute stage, there will be an increase of 0.25 Kp (approximately 13 W) until voluntary exhaustion27. O2 consumption will be measured with each breath, using the gas analyzer (Quark - PFT®, COSMED, Italy), which will be calibrated according to the manufacturer's specifications. Blood samples (25 ?L) will be collected from the earlobe at each stage's end to analyze the blood [La-]. Concomitantly, HR and PSE will be monitored at the end of each stage. VO2max will be defined as the highest mean VO2 in the last 60 s in the test, considering at least three of the criteria: volitional exhaustion, blood [La-] ? 8.0 mmol,> 90% of the maximum HR predicted for age (HRmax = 220 - age), PSE ? 9, respiratory quotient ? 1.10, inability to maintain a frequency of at least 60 rpm. The iVO2max will be the lowest intensity at which the individual reaches VO2max during the test. If the individual doesn't sustain the intensity until the stage's end, the iVO2max will be assumed like peak power (PP), estimated by equation.<br>A partial evaluation containing the incremental test will be carried out at week 5 (half of the intervention) to adjust the training load (evaluation 2). Therefore, the incremental test will be performed in four moments: evaluation 1 (week 0 - pre), evaluation 2 (week 5 - half of the intervention), evaluation 3 (week 9 - post), and evaluation 4 (week 13 - four after the end) intervention).<br>;Improvements in body composition<br><br>For the analysis of body composition and the distribution of lean, bone, and adipose tissue, the dual-energy X-ray absorptiometry technique (iDXA - GE Lunar - DPX-NT) will be used. The radiation dose that the participants will receive will be less than 0.0545, equivalent to 50 times less than an X-ray exam. When positioned on the device, the subjects will remain immobile in the supine position during the exam (about 15 min). The method will estimate body composition by dividing the body into three anatomical compartments: fat-free mass, fat mass and bone mineral content.→For all primary and secondary outcomes, parameters will be presented in absolute numbers and the pre and post-intervention comparisons in percentages (delta). When necessary, categories will be used to express the results.<br><br>Improvements in lung function<br><br>For pulmonary function evaluation, a portable spirometer (Micro Medical, Rochester, United Kingdom) will be used, following the current standards46 and guidelines for pulmonary function tests. Participants will be instructed to perform the maneuvers to assess forced vital capacity (FVC) and forced expiratory volume (FEV).;Improvements in autonomic parameters<br><br>HR variability will be analyzed by acquisition at each beat to determine RR intervals and analyze autonomic variables. These responses will be subjected to digital filtering performed by the device's software (Polar Precision Performance, version 3.0) by identifying and correcting some ectopic beats (irregularities in heart rhythm), involving extrasystole and consecutive compensatory pause. The analysis of HR variability will be performed by linear methods, analyzed in the domains of time (SDNN and RMSSD) and frequency (LF, HF, and LF/HF ratio). The spectral analysis will be calculated using the Fast Fourier Transform algorithm.;Improvements in body composition<br><br>For the analysis of body composition and the distribution of lean, bone, and adipose tissue, the dual-energy X-ray absorptiometry technique (iDXA - GE Lunar - DPX-NT) will be used. The radiation dose that the participants will receive will be less than 0.0545, equivalent to 50 times less than an X-ray exam. When positioned on the device, the subjects will remain immobile in the supine position during the exam (about 15 min). The method will estimate body composition by dividing the body into three anatomical compartments: fat-free mass, fat mass and bone mineral content.;Improvements in maximum aerobic power (VO2max) and anaerobic threshold (AT) <br><br>An incremental test will be used to estimate AT, VO2max, and iVO2max. The warm-up will be 5 min in cycle ergometer (E200, COSMED, Italy) without load (0 Kp). At each 2-minute stage, there will be an increase of 0.25 Kp (approximately 13 W) until voluntary exhaustion27. O2 consumption will be measured with each breath, using the gas analyzer (Quark - PFT®, COSMED, Italy), which will be calibrated according to the manufacturer's specifications. Blood samples (25 ?L) will be collected from the earlobe at each stage's end to analyze the blood [La-]. Concomitantly, HR and PSE will be monitored at the end of each stage. VO2max will be defined as the highest mean VO2 in the last 60 s in the test, considering at least three of the criteria: volitional exhaustion, blood [La-] ? 8.0 mmol,> 90% of the maximum HR predicted for age (HRmax = 220 - age), PSE ? 9, respiratory quotient ? 1.10, inability to maintain a frequency of at least 60 rpm. The iVO2max will be the lowest intensity at which the individual reaches VO2max during the test. If the individual doesn't sustain the intensity until the stage's end, the iVO2max will be assumed like peak power (PP), estimated by equation.<br>A partial evaluation containing the incremental test will be carried out at week 5 (half of the intervention) to adjust the training load (evaluation 2). Therefore, the incremental test will be performed in four moments: evaluation 1 (week 0 - pre), evaluation 2 (week 5 - half of the intervention), evaluation 3 (week 9 - post), and evaluation 4 (week 13 - four after the end) intervention).<br>;Improvements in inflammatory mediators and hematological parameters<br><br>Dosage of inflammatory soluble protein mediators<br>The quantification of cytokines IL-6, IL-8, IL-10, and TNF-alpha will be performed by the ELISA - Multiplex method (R&D Systems, Billings, USA).<br><br>Inflammatory lipid mediators<br>The profiles of eicosanoids and endocannabinoids will be evaluated in plasma by mass spectrometry in samples collected with EDTA anticoagulant at the facility available from FCFRP - USP. The standard protocol with solid-phase extraction (SPE) and the identification and quantification of eicosanoids and endocannabinoids will be used. Data acquisition and processing will be performed using PeakViewTM and MultiQuantTM software (Sciex, Foster, CA, USA) (Sorgi CA, et al, Scientific Data, 2018).<br><br>Hematological parameters<br>Hemogram parameters, such as total erythrocyte count, hematocrit, hemoglobin concentration, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, total leukocyte, platelet, and reticulocyte count will be evaluated. Total cholesterol, triglycerides, HDL-c, LDL-c, lactic dehydrogenase, and liver enzymes (TGO and TGP) will also be analyzed. The collection will be carried out at EEFERP by a trained and specialized professional. Later, the samples will be sent for analysis at the Clinical Analysis Laboratory of FCFRP - USP, according to the technical service's standard routine and methodology. To determine the EPO concentration in the plasma samples, the EPO Immunoassay ELISA Kit will be used.<br><br> | | | | No | False | | |
| RBR-88bjcv | 2 November 2021 | Randomized, controlled study of inflammation inhibition in the treatment of pneumonia by the SARS-Cov-2 virus
COMPVID STUDY | Randomized, controlled study of complement inhibition in the treatment of SARS-Cov-2 pneumonia
COMPVID STUDY - -: - | | Hospital Eduardo de Menezes | 06/11/2020 | 20201106 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-88bjcv | Recruiting | No | 18Y | 80Y | - | 19/08/2020 | | Intervention | Clinical trial of treatment, randomized-controlled, parallel, double-blind, with two arms | 2 | Brazil | Mauro | Teixeira | Instituto de Ciências Biológicas - Universidade Federal de Minas Gerais, Av. Pres. Antônio Carlos, 6627 - Pampulha, Belo Horizonte - MG | mmtex.ufmg@gmail.com | +553134092501 | UNIVERSIDADE FEDERAL DE MINAS GERAIS | Inclusion criteria: Be between 18 and 80 years old; weight between 50 and 100 kg; maximum of 10 days of symptoms; admission to the intensive care unit or COVID-19 unit with suspected COVID-19 pneumonia and 93% less oxygen saturation in room air, but not receiving mechanical ventilation; diagnosis of COVID-19 infection based on a viral polymerase chain reaction test, rapid test or based on symptoms associated with a consistent lung tomography; be able to provide a free consent form or have the free consent form provided by a legally designated representative. | Exclusion criteria: Patients who received treatment with inhibitors of complement system factors (such as eculizumab) or treatments with therapy with biological immunomodulators (example tocilizumab, etanercept, infliximab) in the 4 weeks prior to the admission in the study; patients involved in other clinical studies; patients with active tissue or systemic bacterial or fungal infection; pregnant or breastfed patients; patients with more than ten days of symptoms. | Pneumonia by the SARS-CoV-2 virus
;U.07.1 | PHASE A: Treatment of 5 patients with Nomacopan subcutaneously for at least 7 days, until completing 14 days. When the fifth patient completes treatment or withdraws from the study, a drug safety monitoring board will meet and decide whether the study should be continued, terminated or modified. If it has been decided to proceed, phase B begins.<br>PHASE B: 60 patients. 40 patients will receive Nomacopan subcutaneously for at least 7 days, until they are 14 days old. 20 patients will receive placebo subcutaneously at least 7 days, until they are 14 days old.<br>Monitoring: Routine cardiorespiratory monitoring of the patient will be performed twice a day and with the appropriate adjustment to oxygen supplementation to ensure oxygen saturation greater than or equal to 93%.;Drug;E02.319 | Quantify the number of days for respiratory recovery, defined as oxygen saturation greater than 93% measured by pulse oximeter, without oxygen supplementation for at least 24 hours. If the patient achieves this goal, but is kept in the hospital for other reasons (for example, non-respiratory organ dysfunction), the goal will be considered fulfilled.<br><br><br>;With regard to secondary outcomes, it is expected to measure the number of days without a ventilator until hospital discharge; hospitalization time; presence of recovery or death, which will be verified by telephone; what is the frequency, severity and ratio of adverse effects related to treatment; what is the frequency of adverse events that justify premature discontinuation of treatment or study; what are the changes in clinical and laboratory parameters (biochemical, hematological and urinary) between admission to the study and post-treatment. | | | | No | False | | |
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| RBR-5sw6sjz | 2 November 2021 | Use of saliva for screening patients with COVID-19 | Identification of biomarkers in the saliva of patients with COVID-19 for use in screening: a clinical-laboratory study based on artificial intelligence | | Instituto Federal do Paraná | 07/07/2021 | 20210707 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-5sw6sjz | Not Recruiting | No | 20Y | 45Y | - | 01/10/2020 | | Intervention | | | Brazil | Marcelo | Poleti | Alameda Ipê-Rosa, 956 | marcelo_poleti@yahoo.com.br | +55 43 3354-1500 | | Inclusion criteria: Case group: adult adults; 20 to 45 years; the city of Londrina; without comorbidities; non-smoking; of both sexes; with symptoms for CODIV-19; assisted at the Sabará-Londrina Emergency Care Unit.
<br>Control group: adult adults; 20 to 45 years; the city of Londrina; without comorbidities; non-smoking; of both sexes; no symptoms for CODIV-19. | Exclusion criteria: Case group: volunteers who present comorbidities during the execution of the research; who start to use medication for continuous use that interferes with the quantity and quality of saliva; who in the course of the research are hospitalized for the treatment of the disease or give up participating in the research.
<br>Control group: volunteers who present comorbidities during the execution of the research; who start to use medications for continuous use that interfere in the quantity and quality of saliva; and that in the course of the research they are tested positive for COVID-19 or who quit participating of the research. | Coronavirus Infections;37050 | Control group: saliva, blood and naso / oropharynx (swab) samples will be collected from 66 participants at different times after the onset of symptoms: T0 (3 to 8 days); T1 (10 to 15 days) and T2 (17 to 22 days). Saliva will be collected at times T0, T1 and T2, blood at times T0 and T2 and the swab at times T0 and T2. A sample of unstimulated saliva will be collected for 10 minutes. For this, the participants will be seated, in an upright position for 15 minutes before starting the saliva collection. You should not speak or eat before starting collection. Participants will rinse their mouths with 5 ml of water, spit out the water and then discard saliva for 5 minutes after rinsing with water. Then, patients will spit all the saliva into a 200 ml plastic cup. The collected saliva will be transferred to FALCON tubes, using a disposable syringe.<br><br>Case group: 66 participants will be sampled with saliva, blood and the naso / oropharynx (swab) at different times after the onset of symptoms: T0 (3 to 8 days); T1 (10 to 15 days) and T2 (17 to 22 days). Saliva will be collected at times T0, T1 and T2, blood at times T0 and T2 and the swab at times T1 and T2. A sample of unstimulated saliva will be collected for 10 minutes. For this, the participants will be seated, in an upright position for 15 minutes before starting the saliva collection. You should not speak or eat before starting collection. Participants will rinse their mouths with 5 ml of water, spit out the water and then discard saliva for 5 minutes after rinsing with water. Then, patients will spit all the saliva into a 200 ml plastic cup. The collected saliva will be transferred to FALCON tubes, using a disposable syringe. For 20 participants, 2 ml of saliva will be collected after 5 and 30 minutes of tooth brus;G07.203.650.250.800;E06.761.726.794;E01.370.225.998.110 | Improvement in the screening capacity of COVID-19, assessed by the identification of at least one saliva chemical or protein biomarker. | | 30/06/2021 | | No | False | | |
| → | RBR-107wv6d9 | 2 November 2021 | Dique Filipéia Rehabilitation Protocol for patients with COVID-19
| Evaluation of the Implementation and Effectiveness of the (Dique Filipéia) Physiotherapy Protocol in COVID-19 patients admitted to the Municipal Health Network in the city of João Pessoa | | Laboratório de Estudos do Treinamento Fisico Aplicado a Saúde /Universidade Federal da Paraíba | 07/07/2021 | 20210707 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-107wv6d9 | Recruiting | No | 0 | 0 | - | 01/03/2021 | | Observational | | N/A | Brazil | Murillo;Maria do Socorro→Maria do Socorro;Murillo | Frazão ;Brasileiro-Santos | Cidade Universitária, S/N ;Department of Physical Education. Cidade Universitária. SN | murillo.frazao@gmail.com;sbrasileiro@yahoo.com.br | +55 83 99362-2322;+55 83 982027067 | ; | Inclusion criteria: COVID-19 patients in care at health units and admitted to hospitals; both sexes. | Exclusion criteria: Mechanically ventilated critically ill patients | COVID19;C01.925.782.600.550.200.163 | Patients with COVID-19 are being treated and will be divided into two groups (control group and experimental group).<br>Experimental group: 700 patients with COVID-19, of both genders, were submitted to the rehabilitation protocol "Dique Filipéia".<br>Control group: 300 patients with COVID-19 of both sexes who received daily care by the physiotherapy team, following a procedure/rehabilitation protocol adopted by the hospital or health unit, depending on the clinical condition of each patient.<br>The duration of the intervention protocols, for both groups, depends on the clinical condition of each patient. Procedures are performed daily, with each session lasting between 40 and 60 minutes.<br><br>The "Dique Filipeia" protocol classifies patients into four levels of severity through peripheral oxygen saturation, and patients must maintain saturation greater than or equal to the cutoff point of 93%.<br>Level 0: patient maintains oxygen saturation in room air.<br>Level 1: the patient can maintain oxygen saturation at up to 2 liters of oxygen (O2) per minute.<br>Level 2: the patient can maintain oxygen saturation at 3 to 4 liters of O2 per minute.<br>Level 3: the patient needs more than 4 liters of oxygen per minute to maintain oxygen saturation. Oxygen delivery will be classified with low-flow, high-flow, or non-rebreathed mask systems.<br>Depending on the classification, the patients were submitted to the protocol that recommends a standardization of the conduct of ventilatory support associated with functional rehabilitation, followed by an attempt to wean from oxygen, maintaining the necessary flow to maintain a 93% saturation.<br><br>Level 0 - Functional rehabilitation strategy: Resistance kinesiotherapy for lower limbs in closed chain and walking for 5 minutes (both tw;E02.760.169.063.500;E02.760.169.063.500.387 | Presentation of the expected outcome: To assess the length of stay in COVID-19 patients in care at health units and admitted to hospitals, undergoing the “Dique Filipeia” protocol and to compare with patients who were not summitted to protocol. It is expected that COVID-19 patients undergoing the protocol will be able to reduce hospitalization period, this information will be provided by the health facility or hospital. The length of stay will be presented in absolute value and percentage. | | 31/08/2021 | | No | False | | |
| RBR-95wmphn | 2 November 2021 | Physical activity and physical inactivity in children during the Coronavirus pandemic | Evaluation of the measure of physical activity and exposure to sedentary behavior in preschool children during the Covid-19 pandemic | | Centro Universitário Presidente Tancredo de Almeida Neves | 02/05/2021 | 20210502 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-95wmphn | Not Recruiting | No | 3Y | 7Y | - | 01/04/2021 | | Intervention | | | Brazil | Wagner | Moreira | Av. José Caetano de Carvalho, s/n | wagner.moreira@uniptan.edu.br | +55032999763116 | | Inclusion criteria: Children between the ages of three and seven; of both sexes; who is actively enrolled in the preschool phase of early childhood education; who accept to participate in the study; and sign the Free and Informed Consent Form | Exclusion criteria: Children with intellectual and/or multiple disabilities; cardiorespiratory and orthopedic diseases; who make it impossible to participate in physical activities; and who give up on continuing the study after signing the Free and Informed Consent Form | Sedentary behavior; coronavirus infections;F01.145.179 | After the sample calculation, a minimum sample of 418 participating children is estimated. Children will be selected in the municipality of São João del-Rei / MG, through an invitation sent by the researchers to the children's schools in that municipality, and those interested, will be responsible for disseminating, on social media, the research within their school community. Families, upon receiving the invitation to participate, children and their legal guardians must indicate their agreement to the terms, that soon after it is authorized, the data registration and Physical Activity and Sedentarism questionnaires in Preschoolers will be presented, made available through the same link, sequentially, through the Google Forms platform.;D009043 | It is expected to find a significant number of children who extrapolate their time in front of the television screen, tablets and smartphones. | | 30/11/2021 | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| RBR-25rtydq | 2 November 2021 | Tocilizumab role in reducing the complications of COVID patients
| Tocilizumab role in reducing the complications of COVID patients
- TOCIPAK Tocilizumab in Pakistan | | Lady Reading Hospital-MTI Peshawar | 11/08/2021 | 20210811 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-25rtydq | Not Recruiting | No | 17Y | 0 | - | 16/04/2020 | | Observational | | 3 | Pakistan | Muhammad | Amir | Lady Reading Hospital, Peshawar | mohd_amir80@hotmail.com | ++92-334-3266804 | | Inclusion criteria: Confirmed or suspected SARS-CoV infection; Adult patient; Moderate to Critical COVID Patients | Exclusion criteria: Known hypersensitivity to Tocilizumab or its excipients; patient below 18 years; mild cases of Confirmed or suspected SARS-CoV | Pneumonia due to COVID-19; B34.2 | Single Arm Study: 59 patients admitted for the treatment of COVID-19 patients receive tocilizumab as a dose of 400 mg intravenously in 100 mL NaCl 0.9 % administered in 60 minutes as intervention. <br>Control Group: No control group;D26.670 | Rate of mortality in patients receiving tocilizumab in the hospital, verified by chi square test, it was observed that patients receiving invasive respiratory support were identified to higher risk of mortality than patients receiving oxygen support ( (50 vs 86, p<0.05) | | 30/08/2020 | | No | False | | |
| → | RBR-92vxxk6 | 2 November 2021 | Effect of Hyperbaric Oxygen Therapy (OHB) in patients hospitalized by COVID-19 | Randomized controlled clinical trial on the effect of Hyperbaric Oxygen Therapy (HBO) in non intubated COVID-19 hospitalized patients | | Hospital Risoleta Tolentino Neves | 16/08/2021 | 20210816 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-92vxxk6 | Recruiting | No | 18Y | 0 | - | 24/05/2021 | | Observational | Randomized, safety, efficacy, parallel, open, two-arm, phase 2/3 clinical trial. | 3 | Brazil | Rogério;Túlio→Túlio;Rogério | Noronha;Navarro | Avenida Brasil, 1438, sala 1404;Avenida Brasil, 1438, sala 1404, Funcionários | rogerio_noronha@yahoo.com.br;tulio.navarro@gmail.com | +5531993849007;+5531996131050 | Hospital Risoleta Tolentino Neves; | Inclusion criteria: Patients over 18 years of age; diagnosis confirmed by laboratory tests or computed tomography (CT) of the chest compatible with COVID-19; oxygen saturation below 93% in ambient air; respiratory frequency greater than or equal to 24 resp / min; without a significant commitment from other bodies or systems. | Exclusion criteria: Hemodynamic instability, defined by mean arterial pressure less than 60 mmHg; respiratory failure requiring intubation; blood levels of TGO/TGP greater than 5 times the upper limit of normal; several chronic kidney diseases in stage 4; kidney disease requiring dialysis, that is, with eGFR (Estimated Glomerular Filtration Rate) less than 30 mL/min; transition planned to another hospital, other than a place of study, within 72 hours; infection with the human immunodeficiency virus under highly active antiretroviral therapy (HAART); history of severe depression or attempted suicide or current suicidal ideation; contraindications related to the administration of hyperbaric oxygen: pregnancy; breast-feeding; untreated pneumothorax; use of adriblastine, cisplatin, doxorubicin and mafenide; topical use of iodine and / or petrolatum; advanced emphysema with CO2 retention; claustrophobia; other conditions identified by the hyperbarist team. | Coronavirus infections of unspecified location; Severe acute respiratory syndrome;A00-B99;J00-J99 | Patients will be randomized into two groups in a 1:1 ratio through a four-patient block randomization program.<br>Intervention group: 24 patients (both gender and aged 18 years or above) diagnosed with COVID-19 and respiratory distress, but without intubation criteria at the time, will receive standard treatment for COVID-19 plus hyperbaric oxygen therapy during hospitalization. The maximum of five sessions and time spent in the hyperbaric chamber will be 90 minutes per session.<br>Control group: 24 patients (both gender and aged 18 years or above) diagnosed with COVID-19 and respiratory distress, but without intubation criteria at the time, will receive standard treatment for COVID-19 during hospitalization.;E02.880.690.490 | Evaluate the inpatient time; need for mechanical ventilation (intubation); mortality and incidence of serious adverse events. | | 31/05/2022 | | No | False | | |
| RBR-4bcp54k | 2 November 2021 | Effect of treatment with whole Grape Juice along with traditional treatment in patients hospitalized with covid19 | Evaluation of Grape Juice treatment on Systemic Inflammation, Oxidative Stress, Autonomic Neuromodulation and the impacts of these variables on the severity of progression of Covid19 (2019 coronavirus disease) in hospitalized patients | | Empresa Brasileira de Serviços Hospitalares | 06/09/2021 | 20210906 | REBEC | http://ensaiosclinicos.gov.br/rg/RBR-4bcp54k | Not Recruiting | No | 18Y | 0 | - | 20/10/2020 | | Observational | | 1 | Brazil | Aislan Erick | de Sousa | rua joão angelim 2670 bairro santo antônio | aislanerick1@gmail.com | +55 (86) 988347851 | | Inclusion criteria: Volunteers of both sexes over 18 years of age who had confirmed COVID-19 disease between October 20, 2020 and February 28, 2021, and who were functionally able to ingest food, in addition to agreeing to participate in the study by signing the Informed Consent Form | Exclusion criteria: Patients who had difficulties in ingesting food during the study, died and/or did not undergo the final tests at hospital discharge, in addition to medical recommendations not to ingest the drink, were excluded from the study. | Inflammation; Oxidative Stress; Muscle Strength;C01.748.214 | The sample was randomly composed according to the admission of patients to the hospital who had a confirmed diagnosis for COVID-19.<br>On admission, after randomization and before the start of interventions, peripheral blood samples were collected for analysis of hemodynamic, immunoregulatory, inflammation and oxidative stress markers, and a strength test with a handgrip hydraulic dynamometer was performed. At hospital discharge, blood samples were collected again and a new strength test was performed in both groups. Patients who died and/or were unable to perform the test were excluded from the study.<br>Patients were randomly allocated into two groups, 20 patients in the grape juice group and 16 patients in the control group.<br>The twenty (20) patients in the experimental group, diagnosed with COVID 19, chosen at random, received 10 ml/kg of body weight of whole red grape juice per day, divided into 2 (two) daily fractions, during the period of hospitalization until the time of hospital discharge. In addition to the traditional treatment for covid 19.<br>While the sixteen (16) patients in the control group, diagnosed with COVID 19, chosen at random, received only the traditional treatment for covid 19, during the period of hospitalization until the moment of hospital discharge.<br>Traditional treatment included all the necessary interventions, as per the guidelines of the clinical management protocol for patients suspected and diagnosed with COVID-19 document CDA number: 23524.002456/2021-33-11472418-25/01/2021 of the University Hospital of the Federal University of Piauí HU-UFPI and conduct determined by the attending physician, such as supportive measures, symptomatic, and prevention of complications.;E01.370.225.998.110;G07.203.650.220.500;E07.230.460 | A decrease in the inflammatory marker CRP (C-reactive protein) was observed in both groups. In the Control Group a reduction of 33.81% was observed, however, in the Grape Juice Group the reduction was 71.64%. There was a small increase in the oxidative marker MPO (myeloperoxidase);It is expected to find a clinical improvement in patients hospitalized with covid 19 who were supplemented with whole red grape juice, verified by a decrease in systemic inflammation with a reduction in the inflammatory marker PRC (C-reactive protein) and a reduction in oxidant markers. | | 17/08/2021 | | No | False | | |
| ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... | ... |
| TCTR20200321001 | 3 November 2021 | ED Response against Covid-19 pandemic | Response adjustment of emergency deparytment against Covid-19 pandemic: experience of 5-French academic hospitals. | | Study Group for Efficiency and Quality of Emergency Departments and Non-Scheduled Activities Departm | 21/03/2020 | 20200321 | TCTR | www.thaiclinicaltrials.org/show/TCTR20200321001 | Not Recruiting | No | 18 Years | 95 Years | Both | 20/03/2020 | 5000 | Observational | N/A | N/A | France | Enrique | Casalino | 46 rue Henri Huchard | enrique.casalino@aphp.fr | 33140257761 | APHP | Inclusion criteria: Patients suspected of Covid-19 (fever + cough) presenting:
<br>qSOFA >=1 (respiratory rate ≥ 22, systolic blood pressure ≤ 100 mmHg, or altered mental status) | Exclusion criteria: None | Covid-19 cases management during epidemic phase <br>Covid-19; Emergency; Quality; ;Covid-19; Emergency; Quality; | Rosuvastatin 20 mg film-coated tablet, CRESTOR 20 mg, Reg. No. 1C 33/57 (N), manufactured by IPR Pharmaceuticals Inc., Canovanas, Puerto Rico and imported by AstraZeneca (Thailand) Ltd., Bangkok, Thailand. Each tablet contains 20 mg of rosuvastatin as rosuvastatin calcium.,Generic rosuvastatin 20 mg film-coated tablet;Active Comparator Drug,Active Comparator Drug;Rosuvastatin plasma concentration (reference product),Rosuvastatin plasma concentration (test product) | ED time interval hospital exit Time between ED arrival and hospital admission | | 15/04/2020 | | No | False | | |
| +++ | NCT03831906 | 8 November 2021 | Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children With Severe Pneumonia in High Tuberculosis Burden Countries (TB-Speed Pneumonia) | Impact of Systematic Early Tuberculosis Detection Using Xpert MTB/RIF Ultra in Children With Severe Pneumonia in High Tuberculosis Burden Countries | | Institut National de la Santé Et de la Recherche Médicale, France | 01/02/2019 | 20190201 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT03831906 | Not recruiting | Yes | 2 Months | 59 Months | All | March 20, 2019 | 2570 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | Zambia;Uganda;Mozambique;Côte D'Ivoire;Cameroon;Cambodia;Zambia;Uganda;Mozambique;Côte D'Ivoire;Cameroon;Cambodia | ; ; | Olivier Marcy, MD, PhD;Maryline Bonnet, MD, PhD;Eric Wobudeya, MD, PhD | | ;; | ;; | University of Bordeaux, France;Institut de Recherche pour le Développemnt (IRD) Montpellier, France;MU-JHU Care Ltd, Kampala, Uganda |
<br> Inclusion criteria:
<br>
<br> 1. Children aged 2 to 59 months
<br>
<br> 2. Newly hospitalized for severe pneumonia defined using WHO criteria as cough or
<br> difficulty in breathing with:
<br>
<br> 1. Peripheral oxygen saturation < 90% or central cyanosis, or
<br>
<br> 2. Severe respiratory distress (e.g. grunting, nasal flaring, very severe chest
<br> indrawing), or
<br>
<br> 3. Signs of pneumonia, defined as cough or difficulty in breathing with fast
<br> breathing (tachypnea) and/or chest indrawing, with any of the following danger
<br> signs:
<br>
<br> - Inability to breastfeed or drink,
<br>
<br> - Persistent vomiting
<br>
<br> - Lethargy or reduced level of consciousness
<br>
<br> - Convulsions,
<br>
<br> - Stridor in calm child
<br>
<br> - Severe malnutrition
<br>
<br> 3. Informed consent signed by parent/guardian
<br>
<br> Exclusion criteria:
<br>
<br> - Ongoing TB treatment or history of intake of anti-TB drugs in the last 6 months
<br> | | Tuberculosis;Severe Pneumonia;Covid19 | Diagnostic Test: Xpert MTB/RIF Ultra (Ultra) | All-cause mortality 12 weeks after inclusion | | | | Yes | True | parent | |
| → | NCT04333732 | 2 August 2021→8 November 2021 | CROWN CORONATION: COVID-19 Research Outcomes Worldwide Network for CORONAvirus prevenTION | An International, Multi-site, Bayesian Platform Adaptive, Randomized, Placebo-controlled Trial Assessing the Effectiveness of Candidate Agents in Mitigating COVID-19 Disease in Adults | CROWN CORONA | Washington University School of Medicine | 31/03/2020 | 20200331 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04333732 | Not recruiting | Yes | 18 Years | N/A | All | September 4, 2020 | 3545 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 3 | Zimbabwe;Uganda;Netherlands;Ireland;Canada;Australia;Zambia;United States;United Kingdom;South Africa;Ghana;Zambia;United Kingdom;South Africa;Ghana;United States | ; ; | Michael S. Avidan, MBBCh;Ramani Moonesinghe, MD;Helen Rees, MD | | ;; | ;; | Washington Univeristy School of Medicine;University College, London;Wits University |
<br> Inclusion criteria
<br>
<br> 1. Volunteers without clinical evidence of COVID-19 infection aged 18 years and older.
<br>
<br> 2. Healthcare workers based in a primary, secondary or tertiary healthcare setting with a
<br> high risk of developing COVID-19 due to their potential exposure to patients with
<br> SARS-CoV-2 infection.
<br>
<br> 3. Must have a mobile phone and access to the Internet for data collection purposes.
<br>
<br> 4. Participants who are willing and able to provide informed consent via an electronic
<br> consent process.
<br>
<br> Exclusion criteria
<br>
<br> 1. Prior enrollment into other COVID-19 interventional prevention or treatment trials
<br> (observational trials not excluded).
<br>
<br> 2. Self-reported or diagnosed current infection with SARS-CoV-2 or previous COVID-19
<br> diagnosis.
<br>
<br> 3. Self-reported current acute respiratory infection.
<br>
<br> 4. Concurrent and/or recent involvement in other research or use of the investigational
<br> product, a product considered to be equivalent to the investigational product, or any
<br> other product that is likely to interfere with the investigational products in this
<br> trial used within three months of study enrolment.
<br>
<br> 5. Self-reported known allergies to any of the IMPs and excipients of the IMPs and
<br> placebo.
<br>
<br> 6. Self-reported presence or history of the conditions listed in the appendices.
<br>
<br> 7. Self-reported current use of medication known to interact with any of the medications
<br> listed in the appendices.
<br>
<br> 8. Inability or unwillingness to be followed up for the trial period.
<br>
<br> For M-M-R II
<br>
<br> - Pregnant women.
<br>
<br> - Individuals receiving high dose corticosteroids, other immuno-suppressive drugs,
<br> alkylating agents or anti-metabolites.
<br>
<br> - Individuals undergoing radiotherapy.
<br>
<br> - Any malignant disease either untreated or currently undergoing therapy.
<br>
<br> - History of administration of gammaglobulin or blood transfusions within the previous 3
<br> months.
<br>
<br> - Participants with an allergy to the MR (MMR) vaccine or its components, including
<br> neomycin.
<br>
<br> - Idiopathic thrombocytopenic purpura (ITP)
<br>
<br> - Untreated tuberculosis
<br>
<br> - Prior receipt of any vaccines (licensed or investigational) =30 days before enrollment
<br>
<br> - Planned receipt of any vaccine other than the study intervention within 30 days before
<br> and after the study vaccination (not including the flu vaccination via injection)
<br>
<br> - Prior receipt of an investigational or licensed vaccine likely to impact on
<br> interpretation of the trial data (e.g. Adenovirus vectored vaccines, any coronavirus
<br> vaccines).
<br>
<br> - Any confirmed or suspected immunosuppressive or immunodeficient state, including
<br> untreated HIV infection with a CD4T count <200 /mL
<br>
<br> - Asplenia
<br> | | COVID 19 | Drug: MR or M-M-R II ® vaccine;Drug: Placebo | Symptomatic COVID-19 | | | | Yes | True | parent | |
| → | NCT04336215 | 22 February 2021→8 November 2021 | Rutgers COVID-19 Cohort Study | Cohort Study of SARS-CoV-2 Incidence, Transmission, and Disease Severity in Healthcare Workers | | Rutgers, The State University of New Jersey | 02/04/2020 | 20200402 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04336215 | Recruiting→Not recruiting | No | 20 Years | N/A | All | April 7, 2020 | 750→865 | Observational | | | United States | ; ; → ; | Jeffrey L Carson, MD;Reynold A Panettieri, MD;Jeffrey L Carson, MD→Jeffrey L Carson, MD;Reynold A Panettieri, MD | | ;;jeffrey.carson@rutgers.edu→; | ;;732-235-7122→; | Rutgers Biomedical Health Sciences;Rutgers Institute for Translational Medicine and Science;→Rutgers Biomedical Health Sciences;Rutgers Institute for Translational Medicine and Science |
<br> Inclusion Criteria:
<br>
<br> - 20 years and older
<br>
<br> - Hospital and RBHS healthcare workers who have regular direct patient contact (=3
<br> patients/shift) in emergency rooms or inpatient settings that is expected to continue
<br> regularly over the next =3 months and who work =20 hours in the hospital weekly
<br> (residents, clinical fellows, attending physicians, nurse practitioners, physician
<br> assistants, registered nurses, license practice nurses, medical technicians,
<br> respiratory therapists, physical therapists, clinical pharmacists, dentists, dental
<br> hygienists, or dental assistants)
<br>
<br> - Hospital workers who do not have patient contact and non-healthcare from the Rutgers
<br> faculty, postdoctoral students, administrators, and staff.
<br>
<br> - Household members in a subset of the participants who test positive and negative for
<br> SARS-CoV-2
<br>
<br> Exclusion Criteria:
<br>
<br> - Previous diagnosis with COVID-19
<br>
<br> - Pregnant or have been diagnosed with a new medical condition in the past 30 days or
<br> have had a change in medications in the past 30 days
<br>
<br> - Participants who have been hospitalized in the past 30 days, had and had an emergency
<br> room, urgent care visit, or have had surgery.
<br>
<br> - Participants who have a fever on the day of their first visit to the study site (for
<br> consent, biospecimen collection, etc.).
<br> | | Coronavirus;SARS-CoV-2 | Other: Non-Interventional | Prevalence;Incidence | | | | Yes | False | | |
| → | NCT04341116 | 17 August 2021→8 November 2021 | Study of TJ003234 (Anti-GM-CSF Monoclonal Antibody) in Subjects With Severe Coronavirus Disease 2019 (COVID-19) | A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of TJ003234 in Subjects With Severe Coronavirus Disease 2019 (COVID-19) | | I-Mab Biopharma Co. Ltd. | 04/04/2020 | 20200404 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04341116 | Recruiting | No | 18 Years | N/A | All | April 11, 2020 | 384 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States | ; | Claire Xu, MD, PhD;US Site Head | | ;US.Info@I-MabBiopharma.com | ;240-767-6981 | I-Mab Biopharma US Limited; |
<br> Inclusion Criteria:
<br>
<br> - Age: 18 years or older (including 18 years); male or female
<br>
<br> - Laboratory-confirmed SARS-CoV-2 or COVID-19 infection as determined by polymerase
<br> chain reaction (PCR) or other commercial or public health assay.
<br>
<br> - Bilateral lung infection confirmed by imaging.
<br>
<br> - Severe disease that meets one of the following conditions: (i) At rest, finger blood
<br> oxygen saturation = 93% or PaO2/FiO2 = 300 mmHg; (ii) Requiring non-invasive or
<br> invasive mechanical ventilation; OR (iii) Requiring high flow oxygen = 15L/min
<br>
<br> - Hospitalized for no more than 5 calendar days at the time of screening
<br>
<br> Exclusion Criteria:
<br>
<br> - Any previous and/or current clinically significant disease or condition that has not
<br> been stable within 3 months prior to enrollment, or acute illness, planned medical/
<br> surgical procedure, or any trauma that occurred within 2 weeks prior to enrollment.
<br>
<br> - Chronic obstructive pulmonary disease (COPD) patients requiring inhaled
<br> corticosteroid, long-acting beta-adrenergic agonists, long-acting anticholinergics, or
<br> long-term oxygen therapy (Part 1 only).
<br>
<br> - Pulmonary interstitial disease, pulmonary alveolar proteinosis, and pulmonary
<br> granulomatosis.
<br>
<br> - Cardiovascular event in the 3 months prior to study drug administration: acute
<br> myocardial infarction or unstable angina pectoris, severe arrhythmia (multiple sources
<br> of frequent ventricular premature beat, ventricular tachycardia and ventricular
<br> fibrillation); New York Heart Association Classification (NYHA): Class III-Class IV.
<br>
<br> - Blood system disorders or routine blood analysis test abnormalities: Hemoglobin < 8
<br> g/dL; Absolute neutrophil count (ANC) <1500 × 109/L; Platelets < 50 × 109/L.
<br>
<br> - Dependence on glucocorticoid treatment equivalent to methylprednisolone 2 mg/kg/ day
<br> or more or long-term use of anti-rejection or immunomodulatory drugs.
<br>
<br> - Subjects that have been on invasive mechanical ventilation for =120 hours at the time
<br> of dosing
<br>
<br> - Subjects that require ECMO.
<br>
<br> - Pregnant or breastfeeding females.
<br> | | Coronavirus Disease 2019 COVID-19 | Drug: TJ003234;Drug: Placebo | Proportion (%) of subjects alive and free of mechanical ventilation | | | | Yes | False | | |
| → | NCT04344587 | 14 June 2021→8 November 2021 | Awake Prone Position for Early Hypoxemia in COVID-19 | Awake Prone Position for Early Hypoxemia in COVID-19 | APPEX-19 | Boston University | 08/04/2020 | 20200408 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04344587 | Not recruiting | No | 18 Years | N/A | All | April 23, 2020 | 305 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | United States;Spain;United States | | Allan J Walkey, MD | | | | Boston University |
<br> Inclusion Criteria:
<br>
<br> - Assigned to or admitted to a COVID-19 ward team at a participating site (these teams
<br> only admit patients who are under investigation for COVID-19 or who have confirmed
<br> COVID-19 infection) via the emergency department (ED) within the last 24 hours
<br>
<br> - Have access to their own functioning smartphone in the hospital room
<br>
<br> - English or Spanish-speaking
<br>
<br> - Ability to read simple instructions and answer simple written questions
<br>
<br> Exclusion Criteria:
<br>
<br> Baseline patient factors
<br>
<br> - Inability to operate the hospital bed
<br>
<br> - Inability to lie flat comfortably
<br>
<br> - Inability to lie flat without shortness of breath
<br>
<br> - Inability to turn over independently
<br>
<br> Medical comorbidities
<br>
<br> - Hemoptysis in the last 2 days
<br>
<br> - Prior lung transplant
<br>
<br> - Dementia
<br>
<br> Acute issues
<br>
<br> - Deep venous thrombosis treated for less than 2 days
<br>
<br> - Unstable spine, femur, or pelvic fractures
<br>
<br> - Mean arterial pressure lower than 65 mmHg
<br>
<br> - Receiving =6 liters per minute of supplemental oxygen via nasal cannula, nasal
<br> pendant, or shovel mask
<br>
<br> - Receiving supplemental oxygen via more aggressive methods (e.g. Venturi mask or
<br> non-rebreather mask)
<br>
<br> Recent interventions
<br>
<br> - Chest tube in place
<br>
<br> - Tracheal surgery or sternotomy during the previous 15 days
<br>
<br> - Serious facial trauma or facial surgery during the previous 15 days
<br>
<br> - Cardiac pacemaker inserted in the last 2 days
<br>
<br> Other
<br>
<br> - Pregnancy
<br>
<br> - Comfort measures only status
<br>
<br> - Prisoner
<br> | | COVID-19 | Other: Self-prone position recommendation;Other: Usual care | Change in respiratory status | | | | Yes | False | | |
| → | NCT04347538 | 1 November 2021→8 November 2021 | Impact of Nasal Saline Irrigations on Viral Load in Patients With COVID-19 | Impact of Nasal Saline Irrigations on Viral Load in Patients With COVID-19 | | Vanderbilt University Medical Center | 11/04/2020 | 20200411 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04347538 | Not recruiting | No | 18 Years | N/A | All | May 1, 2020 | 90 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United States | ; | Kyle Kimura, MD;Justin H. Turner, MD, PhD | | ; | ; | Vanderbilt University Medical Center;Vanderbilt University Medical Center |
<br> Inclusion Criteria:
<br>
<br> - Patients testing positive for COVID-19 at Vanderbilt University Medical Center or
<br> VUMC-associated testing centers
<br>
<br> - Age of 18 years or greater
<br>
<br> - Patients must be planning self-quarantine after infection in the greater Nashville
<br> area within a 30-mile radius of Vanderbilt University Medical Center
<br>
<br> Exclusion Criteria:
<br>
<br> - Requiring hospitalization - only outpatient COVID-19 cases are eligible for the study
<br>
<br> - Current use of nasal saline irrigations or other intranasal medications
<br>
<br> - Inability to perform saline irrigations/nasal swabs in separate bathroom away from
<br> household contacts
<br> | | COVID 19 | Other: Saline Nasal Irrigation;Other: Saline with Baby Shampoo Nasal Irrigation | Change in SARS-CoV-2 mucosal immune response in the nasopharynx;Change in microbial load in the nasopharynx;Change in Viral Load in the nasopharynx over the course of COVID-19 infection | | | | Yes | False | | |
| → | NCT04349098 | 12 December 2020→8 November 2021 | Evaluation of Activity and Safety of Oral Selinexor in Participants With Severe COVID-19 Infection | A Phase 2 Randomized Single-Blind Study to Evaluate the Activity and Safety of Low Dose Oral Selinexor (KPT-330) in Patients With Severe COVID-19 Infection | Coronavirus | Karyopharm Therapeutics Inc | 14/04/2020 | 20200414 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04349098 | Recruiting→Not recruiting | No | 18 Years | N/A | All | April 17, 2020 | 230→190 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). | Phase 2 | United States;Austria;France;Israel;Spain;United Kingdom;Austria;France;Israel;Spain;United Kingdom;United States | ; → | Dayana Michel;Jatin Shah, Chief Medical Officer→Dayana Michel | | ;jshah@karyopharm.com→ | ;(617) 658-0600→ | Karyopharm Therapeutics Inc;→Karyopharm Therapeutics Inc |
<br> Inclusion Criteria:
<br>
<br> - Confirmed laboratory diagnosis of SARS-CoV2 by standard FDA-approved reverse
<br> transcription polymerase chain reaction (RT-PCR) assay or equivalent FDA-approved
<br> testing (local labs).
<br>
<br> - Currently hospitalized.
<br>
<br> - Informed consent provided as above (it is recommended that participants are dosed with
<br> study drug within 12 hours of consent).
<br>
<br> - Has symptoms of severe COVID-19 as demonstrated by:
<br>
<br> - At least one of the following: fever, cough, sore throat, malaise, headache,
<br> muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms
<br> of severe lower respiratory symptoms including dyspnea at rest or respiratory
<br> distress.
<br>
<br> - Clinical signs indicative of lower respiratory infection with COVID-19, with at
<br> least one of the following: respiratory rate = 30 breaths/minute (min), heart
<br> rate = 125/min, SaO2 <93% on room air or requires > 2 liter (L) oxygen by NC in
<br> order maintain SaO2 =93%, PaO2/FiO2 <300 millimeter per mercury (mm/hg).
<br>
<br> - Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics,
<br> hydroxychloroquine) are permitted. If in the physician's judgement, it is in the best
<br> interest of the participant to use anti-viral or anti-inflammatory treatments, these
<br> treatments are to be documented in the participant's chart and entered in the
<br> electronic case report form.
<br>
<br> - Female participants of childbearing potential must have a negative serum pregnancy
<br> test at Screening. Female participants of childbearing potential and fertile male
<br> participants must use highly effective methods of contraception throughout the study
<br> and for 3 months following the last dose of study treatment.
<br>
<br> Exclusion Criteria:
<br>
<br> - Evidence of critical COVID-19 based on:
<br>
<br> - Respiratory failure (defined by endotracheal intubation and mechanical
<br> ventilation, oxygen delivered by noninvasive positive pressure ventilation, or
<br> clinical diagnosis of respiratory failure in setting of resource limitations)
<br>
<br> - Septic shock (defined by Systolic blood pressure [BP] < 90 mm Hg, or Diastolic BP
<br> < 60 mm Hg)
<br>
<br> - Multiple organ dysfunction/failure
<br>
<br> - In the opinion of the investigator, unlikely to survive for at least 48 hours from
<br> screening or anticipate mechanical ventilation within 48 hours.
<br>
<br> - Inadequate hematologic parameters as indicated by the following labs:
<br>
<br> - Participants with severe neutropenia (ANC <1000 x 10^9/L) or
<br>
<br> - Thrombocytopenia (e.g., platelets <100,000 per microliter of blood)
<br>
<br> - Inadequate renal and liver function as indicated by the following labs:
<br>
<br> - Creatinine clearance (CrCL) <20 mL/min using the formula of Cockcroft and Gault
<br>
<br> - Aspartate transaminase (AST) or alanine transaminase (ALT) > 2.5 x upper limit of
<br> normal (ULN)
<br>
<br> - Total bilirubin >1.5 x upper limit of normal (ULN)
<br>
<br> - Hyponatremia defined as sodium < 135 milliequivalents per litre (mEq/L).
<br>
<br> - Unable to take oral medication when informed consent is obtained.
<br>
<br> - Treatment with strong CYP3A inhibitors or inducers.
<br>
<br> - Pregnant and breastfeeding women.
<br> →
<br> Inclusion Criteria:
<br>
<br> - Confirmed laboratory diagnosis of SARS-CoV2 by standard FDA-approved reverse
<br> transcription polymerase chain reaction (RT-PCR) assay or equivalent FDA-approved
<br> testing (local labs).
<br>
<br> - Currently hospitalized.
<br>
<br> - Informed consent provided as above (it is recommended that participants are dosed with
<br> study drug within 12 hours of consent).
<br>
<br> - Has symptoms of severe COVID-19 as demonstrated by:
<br>
<br> - At least one of the following: fever, cough, sore throat, malaise, headache,
<br> muscle pain, shortness of breath at rest or with exertion, confusion, or symptoms
<br> of severe lower respiratory symptoms including dyspnea at rest or respiratory
<br> distress.
<br>
<br> - Clinical signs indicative of lower respiratory infection with COVID-19, with at
<br> least one of the following: SaO2 <92% on room air in last 12 hours or requires >
<br> 4 liters per minute (LPM) oxygen by nasal canula, non-rebreather/Ventimask or
<br> high flow nasal canula in order maintain SaO2 =92%, PaO2/FiO2 <300 millimeter per
<br> mercury (mm/hg).
<br>
<br> - Elevated C-reactive protein (CRP) > 2 x upper limit of normal (ULN).
<br>
<br> - Concurrent anti-viral and/or anti-inflammatory agents (e.g., biologics,
<br> hydroxychloroquine) are permitted. If in the physician's judgment, it is in the best
<br> interest of the participant to use anti-viral or anti-inflammatory treatments, these
<br> treatments are to be documented in the participant's chart and entered in the
<br> electronic case report form.
<br>
<br> - Female participants of childbearing potential must have a negative serum pregnancy
<br> test at Screening. Female participants of childbearing potential and fertile male
<br> participants must use highly effective methods of contraception throughout the study
<br> and for 3 months following the last dose of study treatment.
<br>
<br> Exclusion Criteria:
<br>
<br> - Evidence of critical COVID-19 based on:
<br>
<br> - Respiratory failure (defined by endotracheal intubation and mechanical
<br> ventilation, oxygen delivered by noninvasive positive pressure ventilation, or
<br> clinical diagnosis of respiratory failure in setting of resource limitations)
<br>
<br> - Septic shock (defined by Systolic blood pressure [BP] < 90 mm Hg, or Diastolic BP
<br> < 60 mm Hg)
<br>
<br> - Multiple organ dysfunction/failure
<br>
<br> - In the opinion of the investigator, unlikely to survive for at least 48 hours from
<br> screening or anticipate mechanical ventilation within 48 hours.
<br>
<br> - Inadequate hematologic parameters as indicated by the following labs:
<br>
<br> - Participants with severe neutropenia (ANC <1000 x 10^9/L) or
<br>
<br> - Thrombocytopenia (e.g., platelets <100,000 per microliter of blood)
<br>
<br> - Inadequate renal and liver function as indicated by the following labs:
<br>
<br> - Creatinine clearance (CrCL) <20 mL/min using the formula of Cockcroft and Gault
<br>
<br> - Aspartate transaminase (AST) or alanine transaminase (ALT) > 5 x ULN
<br>
<br> - Hyponatremia defined as sodium < 135 milliequivalents per liter (mEq/L).
<br>
<br> - Unable to take oral medication when informed consent is obtained.
<br>
<br> - Participants with a legal guardian or who are incarcerated.
<br>
<br> - Treatment with strong CYP3A inhibitors or inducers.
<br>
<br> - Pregnant and breastfeeding women.
<br> | | Coronavirus Infection | Drug: Selinexor;Other: Placebo | Percentage of Participants with at Least a 2 Point Improvement in the Ordinal Scale→Percentage of Participants With At-least a 2-Point Improvement in Ordinal Scale | →01/11/2021 | | →https://clinicaltrials.gov/ct2/show/results/NCT04349098 | Yes | False | | →Yes |
| → | NCT04351295 | 17 August 2021→8 November 2021 | Efficacy of Faviprevir in COVID-19 Treatment | Clinical Study Evaluating the Efficacy of Faviprevir in COVID-19 Treatment | | Tanta University | 15/04/2020 | 20200415 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04351295 | Not recruiting | No | N/A→18 Years | N/A→80 Years | All | April 20, 2020 | 92 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2/Phase 3 | Egypt | | sherief Abd-Elsalam, Ass. Prof. | | | | Tanta University - Faculty of Medicine |
<br> Inclusion Criteria:
<br>
<br> - Patients with covid 19
<br>
<br> Exclusion Criteria:
<br>
<br> - Allergy or contraindications to faviprevir
<br> | | COVID | Drug: Favipiravir;Drug: Chloroquine | Number of patients with mortality or need for mechanical ventilation | | | | Yes | False | | |
| → | NCT04356534 | 1 November 2021→8 November 2021 | Convalescent Plasma Trial in COVID -19 Patients | Use of Convalescent Plasma Therapy for COVID-19 Patients With Hypoxia: a Prospective Randomized Trial | | Royal College of Surgeons in Ireland - Medical University of Bahrain | 15/04/2020 | 20200415 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04356534 | Not recruiting | No | 21 Years | N/A | All | April 19, 2020 | 40 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Bahrain | | Manaf Al Qahtani, Dr. | | | | Royal College of Surgeons in Ireland - Bahrain |
<br> Inclusion Criteria:
<br>
<br> - COVID-19 diagnosis
<br>
<br> - Hypoxia, (Oxygen saturation of less than or equal 92% or PO2 < 60mmHg on arterial
<br> blood gas analysis) and patient requiring oxygen therapy
<br>
<br> - Evidence of infiltrates on Chest Xray or CT scan
<br>
<br> - Able to give informed consent
<br>
<br> - Patients between the ages of 21 and above with no upper age.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients with mild disease not requiring oxygen therapy
<br>
<br> - Patients with normal CXR & CT scan
<br>
<br> - Patients requiring ventilatory support
<br>
<br> - Patients with a history of allergy to plasma, sodium citrate or methylene blue
<br>
<br> - Patients with a history of autoimmune disease or selective IGA deficiency.
<br> | | SARS-CoV 2;COVID-19 | Other: plasma therapy using convalescent plasma with antibody against SARS-CoV-2;Other: Routine care for COVID-19 patients | Requirement for invasive ventilation | | | | Yes | False | | |
| → | NCT04358068 | 1 November 2021→8 November 2021 | Evaluating the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19 | A Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy of Hydroxychloroquine and Azithromycin to Prevent Hospitalization or Death in Persons With COVID-19 | | National Institute of Allergy and Infectious Diseases (NIAID) | 20/04/2020 | 20200420 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04358068 | Not recruiting | No | 18 Years | N/A | All | May 13, 2020 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | United States;Puerto Rico | | Davey Smith, MD | | | | University of California, San Diego |
<br> Inclusion Criteria:
<br>
<br> - Documentation of confirmed active severe acute respiratory syndrome coronavirus
<br> (SARS-CoV-2) infection from any respiratory specimen collected =7 days from when the
<br> first dose of study treatment was expected to be taken.
<br>
<br> - Experienced at least one of the following SARS-CoV-2 infection symptoms within 24
<br> hours of screening (symptom(s) must be new or worse compared to pre-COVID-19 health
<br> status):
<br>
<br> - Fever (can be subjective) or feeling feverish
<br>
<br> - Cough
<br>
<br> - Shortness of breath or difficulty breathing at rest or with exertion
<br>
<br> - Sore throat
<br>
<br> - Body pain or muscle pain
<br>
<br> - Fatigue
<br>
<br> - Headache
<br>
<br> - Agreed to not participate in another clinical trial for the treatment of COVID-19 or
<br> SARS-CoV-2 during the study period up until reaching hospitalization or 20 days,
<br> whichever is earliest.
<br>
<br> - Agreed to not obtain study medications outside of the A5395 study.
<br>
<br> Exclusion Criteria:
<br>
<br> - Need for hospitalization or immediate medical attention in the clinical opinion of the
<br> study investigator.
<br>
<br> - History of or current hospitalization for COVID-19.
<br>
<br> - History of ventricular arrhythmia or use of antiarrhythmics within 30 days prior to
<br> entry.
<br>
<br> - Personal or family history of Long QT syndrome.
<br>
<br> - History of kidney disease.
<br>
<br> - History of ischemic or structural heart disease.
<br>
<br> - History of hypokalemia or hypomagnesemia or taking potassium supplementation or
<br> magnesium supplementation
<br>
<br> - Personal medical history of porphyria, retinopathy, severe hepatic impairment, or
<br> glucose-6-phosphate dehydrogenase (G6PD) deficiency.
<br>
<br> - Used drugs with possible anti-SARS-CoV-2 activity within 30 days prior to study entry,
<br> e.g., remdesivir, lopinavir/ritonavir fixed dose combination, ribavirin, chloroquine,
<br> hydroxychloroquine, and azithromycin, or participation in a clinical trial involving
<br> any of these drugs whether for treatment or prophylaxis.
<br>
<br> - Requirement or expected requirement for a medication that significantly prolongs QT
<br> intervals or increases risk for QT prolongation.
<br>
<br> - Loop diuretics are exceptions to above exclusion criterion but these cannot be used
<br> within 30 days prior to study entry.
<br>
<br> - Participated in a study where co-enrollment was not allowed.
<br>
<br> - Receipt of a SARS-CoV-2 vaccination prior to study entry.
<br>
<br> - Known allergy/sensitivity or any hypersensitivity to components of HCQ, azithromycin,
<br> or their formulation.
<br>
<br> - More than 10 days of any of the following symptoms attributed to the SARS-CoV-2
<br> infection at study entry:
<br>
<br> - Fever (can be subjective) or feeling feverish
<br>
<br> - Cough
<br>
<br> - Shortness of breath or difficulty breathing at rest or with exertion
<br>
<br> - Sore throat
<br>
<br> - Body pain or muscle pain
<br>
<br> - Fatigue
<br>
<br> - Headache
<br>
<br> - Chills
<br>
<br> - Nasal obstruction or congestion
<br>
<br> - Loss of taste or smell
<br>
<br> - Nausea or vomiting
<br>
<br> - Diarrhea
<br> | | COVID-19;SARS-CoV 2 | Drug: Hydroxychloroquine (HCQ);Drug: Azithromycin (Azithro);Drug: Placebo for Hydroxychloroquine;Drug: Placebo for Azithromycin | Number of Participants Who Died From Any Cause or Were Hospitalized | 01/04/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04358068 | Yes | False | | Yes |
| → | NCT04381988 | 1 November 2021→8 November 2021 | A Study of Hydroxychloroquine vs Placebo to Prevent COVID-19 Infection in Patients Receiving Radiotherapy | A Phase II Randomized Double-Blind Placebo-Controlled Clinical Trial Of Hydroxychloroquine For Prophylaxis Against Covid-19 In Patients Receiving Radiotherapy (COVID) | | Memorial Sloan Kettering Cancer Center | 08/05/2020 | 20200508 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04381988 | Not recruiting | No | 18 Years | N/A | All | May 7, 2020 | 4 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2 | United States | | Nancy Lee, MD | | | | Memorial Sloan Kettering Cancer Center |
<br> Inclusion Criteria:
<br>
<br> - Age = 18
<br>
<br> - ECOG 0-3
<br>
<br> - For patients who have not started radiation at the time of screening: patients are
<br> required to have a plan in place for a minimum of 10 radiation treatments with or
<br> without concurrent systemic therapy
<br>
<br> - For patients who have already started radiation at the time of screening: patients
<br> must complete enrollment such that they are able to receive at least 10 radiation
<br> treatments with hydroxychloroquine.
<br>
<br> - Disease Site
<br>
<br> - Mandatory inclusion criteria:
<br>
<br> - No COVID-19 symptoms within 14 days of enrollment:
<br>
<br> - (Temp >38C in addition to sore throat, cough, wheezing, chest tightness,
<br> shortness of breath, body aches, chills, diarrhea, and anosmia)
<br>
<br> - If symptoms are present within 14 days of enrollment, patients with a negative
<br> COVID-19 PCR or COVID-19 serology assay are eligible for inclusion.
<br>
<br> - No close contact with confirmed COVID-19 person
<br>
<br> - Close contact defined as:
<br>
<br> - Within 6 feet for prolonged period
<br>
<br> - Cohabitating
<br>
<br> - Optional laboratory criteria (Recommended if available)
<br>
<br> - Negative pre-treatment SARS-CoV-2 rapid antigen test result (within 1 week of
<br> enrollment)
<br>
<br> - Negative pre-treatment SARS-CoV-2 PCR test result (within 1 week of enrollment)
<br> using MSKCC laboratory or outside laboratory assay
<br>
<br> - Negative pre-treatment Standard Q COVID-19 IgM/IgG rapid serology result (within
<br> 1 week of enrollment)
<br>
<br> - Blood serum for SARS-CoV-2 serology tests (being validated by MSKCC)
<br>
<br> - Disease site meets following criteria:
<br>
<br> - Head and Neck / High-Risk Skin Cancer
<br>
<br> - Lung Cancer
<br>
<br> - Breast Cancer
<br>
<br> - Prostate Cancer
<br>
<br> - Central Nervous System Tumors
<br>
<br> - Gastrointestinal System Cancer
<br>
<br> - Gynecologic cancer
<br>
<br> - Other disease sites permitted at PI discretion
<br>
<br> Exclusion Criteria:
<br>
<br> - Previous positive test for SARS-CoV-2
<br>
<br> - Previous positive serology test for SARS-CoV-2
<br>
<br> - Recent Chest CT meeting CT exclusion criteria
<br>
<br> - Live in a skilled nursing facility with COVID-19 symptoms (Temp >38 C in addition to
<br> sore throat, cough, wheezing, chest tightness, shortness of breath, body aches or
<br> chills, diarrhea, anosmia)
<br>
<br> - Known hypersensitivity to hydroxychloroquine or 4-aminoquinoline derivatives
<br>
<br> - Pre-existing retinopathy
<br>
<br> - Known chronic kidney disease, stage 4 or 5, or receiving dialysis
<br>
<br> - Breast Feeding
<br>
<br> - Tamoxifen
<br>
<br> - Absolute neutrophil Count <1,000/ml at registration
<br>
<br> - Concurrent use of any other quinine derivative
<br>
<br> - Antiarrhythmic medications: amiodarone, sotalol, dofetilide, procainamide, quinidine,
<br> flecainide
<br>
<br> - Glucose-6-phosphate dehydrogenase deficiency
<br>
<br> - Pre-treatment corrected QT interval (QTc) =470 milliseconds**
<br>
<br> - Prisoners
<br>
<br> - Inability to participate
<br>
<br> - Psoriasis
<br>
<br> - History of suicidal ideation
<br>
<br> - CT Criteria for Enrollment Exclusion (Optional - only for patients who received a
<br> diagnostic CT as part of standard of care or a thoracic CT as part of radiation
<br> simulation): All patients with COVID-19 typical radiographic findings on CT Chest as
<br> defined by the RSNA will be excluded. Patients with any NEW COVID-19 indeterminate
<br> radiographic findings on CT Chest that are concerning for COVID-19 will be excluded.
<br> COVID-19 indeterminate features are permitted if they can be demonstrated as STABLE on
<br> prior (>14 calendar days) CT Chest or PET/CT. If no prior comparison is available AND
<br> any intermediate or typical feature is present, the patient is not eligible.
<br>
<br> - COVID-19 Atypical Features
<br>
<br> - Isolated lobar or segmental consolidation without GGO
<br>
<br> - Discrete small nodules (centrilobular, "tree-in-bud")
<br>
<br> - Lung cavitation
<br>
<br> - Smooth interlobular septal thickening with pleural effusion
<br>
<br> - COVID-19 Indeterminate Features
<br>
<br> - Multifocal, diffuse, perihilar, or unilateral GGO with or without consolidation
<br> lacking a specific distribution and are non-rounded or non-peripheral
<br>
<br> - Few very small GGO with a non-rounded and non-peripheral distribution
<br>
<br> - COVID-19 Typical Features
<br>
<br> - Peripheral, bilateral GGO with or without consolidation or visible intralobular
<br> lines ("crazy paving")
<br>
<br> - Multifocal GGO of rounded morphology with or without consolidation or visible
<br> intralobular lines ("crazy paving")
<br>
<br> - Reverse Halo sign or other findings of organizing pneumonia ** If pre-treatment
<br> QTC can be decreased to <470, the patient can be re-considered for trial.
<br> | | COVID-19;Cancer | Drug: Hydroxychloroquine;Other: Placebo;Radiation: Radiation therapy | Cumulative Incidence of SARS-CoV-2 Infection | 27/10/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04381988 | Yes | False | | Yes |
| → | NCT04387760 | 1 November 2021→8 November 2021 | Favipiravir vs Hydroxychloroquine vs Control in COVID -19 | Treatment of Covid-19 With Favipiravir Versus Hydroxychloroquine: a Randomized Comparator Trial | | Royal College of Surgeons in Ireland - Medical University of Bahrain | 09/05/2020 | 20200509 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04387760 | Not recruiting | No | 21 Years | N/A | All | August 11, 2020 | 150 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | Bahrain | | Manaf Al Qahtani, Dr. | | | | Royal College of Surgeons in Ireland - Bahrain |
<br> Inclusion Criteria:
<br>
<br> - Admitted COVID-19 patients being treated as an in-patient at a hospital facility.
<br>
<br> - COVID-19 diagnosis confirmed by PCR nasopharyngeal swab.
<br>
<br> - Study participants must be symptomatic with any COVID-19 symptoms defined by the
<br> Bahrain National Protocol
<br>
<br> - Onset of symptoms must be within 10 days prior to enrolment.
<br>
<br> - Study participants must have the ability to give informed consent.
<br>
<br> - Participants must be at minimum 21 years of age.
<br>
<br> - Mild to Moderate COVID-19 disease defined as saturation equals to or more than 93% on
<br> room air or PaO2:FiO2 ratio more than 300 on enrolment.
<br>
<br> Exclusion Criteria:
<br>
<br> - Severe COVID-19 disease: defined as presence of SpO2 less than 93% on room air or a
<br> PaO2 to FiO2 ratio of 300 or lower.
<br>
<br> - Patients on ventilatory support.
<br>
<br> - Cardiac dysfunction that would preclude treatment with hydroxychloroquine:
<br>
<br> 1. Patients on medication known to prolong QT segment.
<br>
<br> 2. Known history of LQT syndrome.
<br>
<br> 3. Acquired QT prolongation at baseline >500ms.
<br>
<br> 4. AV block.
<br>
<br> 5. Bundle Branch Block.
<br>
<br> 6. Known history of Cardiomyopathy, Pulmonary Hypertension, or Sick Sinus Syndrome.
<br>
<br> 7. History of ventricular tachyarrhythmia.
<br>
<br> 8. Patients with implantable cardioverter-defibrillator (ICD).
<br>
<br> 9. Patients with a baseline bradycardia of less than 50 beats per minute.
<br>
<br> - Renal dysfunction (estimated glomerular filtration rate less than 30ml/min).
<br>
<br> - Hepatic dysfunction defined as:
<br>
<br> 1. Transaminitis more than three times the upper limit of normal or
<br>
<br> 2. Chronic liver disease of Child Pugh Class B or higher.
<br>
<br> - Gout or a history of gout
<br>
<br> - Patients that are pregnant or breastfeeding.
<br>
<br> - Patients with a known allergy to an intervention medication.
<br>
<br> - Patients who receive any of the study medications prior to randomization
<br>
<br> - Patient with G6PD
<br>
<br> - Readmission due to COVID19 disease.
<br>
<br> - Participants in any other COVID-19 disease trial.
<br>
<br> - Patients on immunosuppressants, HIV patients, cancer patients who received
<br> chemotherapy within the past 6 months, or who are on chronic oral steroids.
<br>
<br> - Patients unable to give informed consent.
<br> | | SARS-CoV 2;COVID-19 | Drug: Hydroxychloroquine;Drug: Favipiravir;Other: Routine care for COVID-19 patients | Primary outcome is the Medial clinical scale at end of study follow up | | | | Yes | False | | |
| → | NCT04396106 | 12 December 2020→8 November 2021 | Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19)→Safety and Efficacy of AT-527 in Subjects With Moderate Coronavirus Disease (COVID-19) in a Hospital Setting | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of AT-527 in Subjects With Moderate COVID-19 | | Atea Pharmaceuticals, Inc. | 16/05/2020 | 20200516 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04396106 | Recruiting | Yes | 45 Years→18 Years | 80 Years→N/A | All | May 26, 2020 | 190 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2 | United States;Ukraine;South Africa;Romania;Moldova, Republic of;Brazil;Belgium;Ukraine;South Africa;Romania;Moldova, Republic of;Brazil;Belgium;United States→United States;Ukraine;Spain;South Africa;Romania;Moldova, Republic of;Egypt;Brazil;Belgium;Argentina;Ukraine;Spain;South Africa;Romania;Moldova, Republic of;Egypt;Brazil;Belgium;Argentina;United States | | Clinical Trials Administrator | | AteaClinicalTrials@ateapharma.com | 888-481-1607 | |
<br> Key Inclusion Criteria:
<br>
<br> - Hospitalized or in a hospital-affiliated confinement facility
<br>
<br> - SARS-CoV-2 positive
<br>
<br> - Initial COVID-19 symptom onset within 5 days prior to Screening
<br>
<br> - SpO2 = 93% on room air or requires = 2L/min oxygen by nasal cannula or mask to
<br> maintain SpO2 = 93%
<br>
<br> - Must also have a history of at least one of the following known risk factors for poor
<br> outcomes: obesity (BMI>30), hypertension, diabetes or asthma.
<br>
<br> Key Exclusion Criteria:
<br>
<br> - Severe or critical COVID-19 illness: RR =30, HR =125, SpO2 <93% on room air or
<br> requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 =93%, systolic blood
<br> pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300
<br>
<br> - Requires mechanical ventilation
<br>
<br> - Lobar or segmental consolidation on chest imaging.
<br>
<br> - Treatment with other drugs thought to possibly have activity against SARS-CoV-2
<br>
<br> - ALT or AST > 5 x upper limit of normal (ULN)
<br>
<br> - Female subject is pregnant or breastfeeding
<br> →
<br> Key Inclusion Criteria:
<br>
<br> - Hospitalized or in a hospital-affiliated confinement facility
<br>
<br> - SARS-CoV-2 positive
<br>
<br> - Initial COVID-19 symptom onset within 5 days prior to Screening
<br>
<br> - SpO2 = 93% on room air or requires = 2L/min oxygen by nasal cannula or mask to
<br> maintain SpO2 = 93%
<br>
<br> - Must also have a history of at least one of the following known risk factors for poor
<br> outcomes: obesity (BMI>30), hypertension, diabetes or asthma.
<br>
<br> Key Exclusion Criteria:
<br>
<br> - Severe or critical COVID-19 illness: RR =30, HR =125, SpO2 <93% on room air or
<br> requires >2L/min oxygen by nasal cannula or mask to maintain SpO2 =93%, systolic blood
<br> pressure < 90 mm Hg, diastolic blood pressure < 60 mm Hg or PaO2/FiO2 <300
<br>
<br> - Requires mechanical ventilation
<br>
<br> - Lobar or segmental consolidation on chest imaging.
<br>
<br> - Treatment with other drugs thought to possibly have activity against SARS-CoV-2
<br>
<br> - ALT or AST > 5 x upper limit of normal (ULN)
<br>
<br> - Female subject is pregnant or breastfeeding
<br>
<br> - Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day
<br> 14 visit (Part B).
<br> | | COVID-19 | Drug: AT-527;Other: Placebo→Drug: AT-527;Other: Placebo;Drug: AT-527;Other: Placebo | Proportions (active vs. placebo) of subjects with progressive respiratory insufficiency.;Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events→Part A: Proportions (active vs. placebo) of subjects with progressive respiratory insufficiency.;Parts A and B: Proportions (active vs. placebo) of subjects experiencing treatment-emergent adverse events;Part B: Change from baseline in amount of SARS-CoV-2 virus RNA | | | | Yes | True | parent | |
| → | NCT04399356 | 1 November 2021→8 November 2021 | Niclosamide for Mild to Moderate COVID-19 | Niclosamide for Patients With Mild to Moderate Disease From Novel Coronavirus (COVID-19) | | Tufts Medical Center | 19/05/2020 | 20200519 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04399356 | Not recruiting | No | 18 Years | N/A | All | October 1, 2020 | 73 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2 | United States | | Harry P Selker, MD | | | | Tufts Medical Center |
<br> Inclusion Criteria:
<br>
<br> - Positive SARS-CoV-2 test by PCR
<br>
<br> - No requirement of oxygen supplementation
<br>
<br> - Ability to take oral medication
<br>
<br> Exclusion Criteria:
<br>
<br> - Known allergic reactions to any components of Niclosamide medication
<br>
<br> - Participation in another trial or use of any experimental treatment for COVID-19,
<br> including chloroquine, hydroxychloroquine, remdesivir, and lopinavir/ritonavir
<br>
<br> - Hospitalization or requirement of hospitalization at the time of enrollment
<br> | | COVID-19 | Drug: Niclosamide;Drug: Placebo;Other: Telehealth monitoring | Change in respiratory viral clearance (by PCR) | | | | Yes | False | | |
| → | NCT04400058 | 1 November 2021→8 November 2021 | Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression | Efficacy and Safety of Octagam 10% Therapy in COVID-19 Patients With Severe Disease Progression | | Octapharma | 21/05/2020 | 20200521 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04400058 | Not recruiting | No | 18 Years | N/A | All | June 1, 2020 | 208 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States;Russian Federation;Ukraine;Russian Federation;Ukraine;United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Adult aged =18years old
<br>
<br> 2. Provide voluntary, fully informed written and signed consent before any study-related
<br> procedures are conducted
<br>
<br> 3. Able to understand and comply with the relevant aspects of the study protocol
<br>
<br> 4. Laboratory (RT-PCR) confirmed COVID-19 infection on throat swab and/or sputum and/or
<br> lower respiratory tract samples
<br>
<br> 5. Hospitalized with a resting room-air SpO2 of =93% or PaO2/FiO2 ratio <300mmHg.
<br> Measurement can be taken from documented source records in the 24 hours prior to
<br> screening
<br>
<br> 6. Chest imaging confirming lung involvement
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Existence of other evidence that can explain pneumonia including but not limited to:
<br> Influenza A virus, influenza B virus, bacterial pneumonia (as suggested by the
<br> combined clinical picture, radiological findings and known laboratory results [eg,
<br> elevated procalcitonin >0.5ng/mL and concomitant neutrophilia]), known fungal
<br> pneumonia, suspected fungal pneumonia based on compromised immune system with a
<br> history of past fungal infections, noninfectious causes, etc.
<br>
<br> 2. Known history of serious allergic reactions, including anaphylaxis, to IVIG or its
<br> preparation components
<br>
<br> 3. Subjects with a history of thromboembolic event (TEE) within the last 12 months, such
<br> as deep vein thrombosis, pulmonary embolism, myocardial infarction, ischemic stroke,
<br> transient ischemic attack, peripheral artery disease (Fontaine IV)
<br>
<br> 4. Subjects with an underlying medical condition that can lead to hypercoagulable states
<br> and hyperviscosity such as antithrombin III deficiency, Factor V Leiden, Protein C
<br> deficiency, antiphospholipid syndrome and malignancy
<br>
<br> 5. Known history of selective IgA deficiency with antibodies against IgA
<br>
<br> 6. Subjects with conditions such as human immunodeficiency virus (HIV) infection, known
<br> acute or chronic hepatitis B or C (HBsAg positive or HCV ribonucleic acid (RNA) PCR
<br> positive or currently treated with antivirals), pulmonary fibrosis, elevated
<br> procalcitonin (> 0.5) with concomitant neutrophilia (elevated polys), heparin induced
<br> thrombocytopenia (HIT), and moderate to severe renal dysfunction (per investigator
<br> discretion based on estimated glomerular filtration rate [eGFR] <59 mL/min/1.73 m2, as
<br> defined by KDIGO Clinical Practice Guideline):
<br>
<br> - Moderately reduced GFR (G3a): GFR = 45 to 59 ml/min/1.73 m2
<br>
<br> - Moderately reduced GFR (G3b): GFR = 30 to 44 ml/min/1.73 m2
<br>
<br> - Severely reduced GFR (G4): GFR = 15 to 29 ml/min/1.73 m2
<br>
<br> - Kidney failure (G5): GFR <15 ml/min/1.73 m2
<br>
<br> 7. Currently requiring IMV (invasive mechanical ventilation or having received IMV during
<br> the last 30 days
<br>
<br> 8. Known clinically significant preexisting lung, heart, or neuromuscular disease that,
<br> in the investigator's opinion, would impact subject's ability to complete study or may
<br> confound the study results
<br>
<br> 9. Body weight >125 kg
<br>
<br> 10. Women who are pregnant or breast-feeding
<br>
<br> 11. Subjects who received COVID-19 convalescent plasma, IVIG products, anti-interleukin
<br> agents (eg, Tocilizumab), or interferons for their COVID-19 disease before enrollment
<br> or plan to receive this treatment during the course of the study
<br>
<br> 12. Enrolled in other experimental interventional studies or taking experimental
<br> medications (ie, convalescent plasma). Diagnostic studies can be allowed if the
<br> anticipated total blood volume to be drawn across both studies and for therapeutic
<br> purposes does not exceed 450 mL over any 8-week period.
<br> | | Covid-19 | Biological: Octagam 10%;Other: Placebo | Stabilization or Improvement in Clinical Status;Descriptive Clinical Status Analysis | | | | Yes | False | | |
| → | NCT04401436 | 1 November 2021→8 November 2021 | COVID-19 Associated Lymphopenia Pathogenesis Study in Blood | COVID-19-associated Lymphopenia Pathogenesis Study in Blood | | National Institute of Allergy and Infectious Diseases (NIAID) | 22/05/2020 | 20200522 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04401436 | Recruiting | No | 18 Years | N/A | All | May 22, 2020 | 350 | Observational | | | United States | ; | Irini Sereti, M.D.;Irini Sereti, M.D. | | ;isereti@niaid.nih.gov | ;(301) 496-5533 | National Institute of Allergy and Infectious Diseases (NIAID); |
<br> - INCLUSION CRITERIA:
<br>
<br> 1. Aged >=18 years.
<br>
<br> 2. Diagnosis of COVID-19 via molecular assay or other commercial or public health
<br> assay.
<br>
<br> 3. Meets one of the following criteria for COVID-19:
<br>
<br> 1. Group A, mild clinical presentation: asymptomatic to oxygen requirements
<br> <-4L nasal cannula (NC).
<br>
<br> 2. Group B, moderate clinical presentation: oxygen requirements >4L NC to <=50%
<br> fraction of inspired oxygen (FiO2) on high-flow oxygen devices.
<br>
<br> 3. Group C, severe clinical presentation: non-invasive ventilation with oxygen
<br> requirements >50% FiO2 on high-flow oxygen devices, any other modality of
<br> non-invasive ventilation, or mechanical ventilation.
<br>
<br> 4. Group D, recovered: meets CDC criteria for discontinuation of
<br> transmission-based precautions and disposition of patients with COVID-19 in
<br> healthcare settings. Enrollment will occur at least 30 days after the above
<br> criteria were met.
<br>
<br> 4. Able to provide informed consent.
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> Individuals meeting any of the following criteria will be excluded from study
<br> participation:
<br>
<br> 1. Documented history of hemoglobin from most recent blood draw <7g/dL if known.
<br>
<br> 2. Any condition that, in the opinion of the investigator, contraindicates participation
<br> in this study.
<br> | | Coronavirus Disease 2019 | | Evaluation of lymphocyte subsets in patients with COVID-19 at various stages of disease, including recovery. | | | | Yes | False | | |
| → | NCT04410549 | 1 November 2021→8 November 2021 | Pulmonary Optical Coherence Tomography in COVID-19 Patients | Optical Coherence Tomography for Microvascular Lung Vessels Obstructive Thromboinflammatory Syndrome Assessment in Patients With COVID-19: an Exploratory Study | | IRCCS San Raffaele | 21/05/2020 | 20200521 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04410549 | Not recruiting | No | 18 Years | N/A | All | June 1, 2020 | 13 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | Italy;Brazil;Italy;Brazil | | | | | | |
<br> Inclusion Criteria:
<br>
<br> (part A)
<br>
<br> - Severe pulmonary coronarvirus disease 19 (COVID 19) with suspect for MicroCLOTS
<br> (microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome) AND
<br>
<br> - Contrast CT scan negative for pulmonary thrombosis AND
<br>
<br> - D-Dimer > 10 mcg/mL OR
<br>
<br> - 5 < D-dimer < 10 mcg/mL and either C Reactive Protein (CRP) > 100 mg/dL or IL-6 > 6
<br> pg/mL or ferritin > 900 ng/L
<br>
<br> (part B)
<br>
<br> - Severe pulmonary coronarvirus disease 19 (COVID 19) with suspect for MicroCLOTS
<br> (microvascular COVID-19 lung vessels obstructive thromboinflammatory syndrome) AND
<br>
<br> - Contrast CT scan positive for pulmonary thrombosis
<br>
<br> Exclusion Criteria:
<br>
<br> - Age < 18
<br>
<br> - Pregnancy or breastfeeding
<br>
<br> - Known allergy to iodinated contrast dye
<br>
<br> - Hemodynamic instability
<br>
<br> - Glomerular Filtration rate < 30 ml/min
<br>
<br> - Active bleeding or absolute contraindication to anticoagulant therapy
<br> | | Covid19;Pulmonary Embolism | Diagnostic Test: Optical Coherence Tomography (OCT) | optical coherence tomography pulmonary microthrombosis assessment in COVID-19 pneumonia patients | | | | Yes | False | | |
| → | NCT04418947 | 1 November 2021→8 November 2021 | Project Resurgence Communication Trial | Comparison of the Effectiveness of Communication Strategies on the Return to In-Person Visits to a Medical Center After the Emergence of COVID-19: A Randomized Trial | | University of Pennsylvania | 29/05/2020 | 20200529 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04418947 | Not recruiting | No | N/A | N/A | All | June 15, 2020 | 11120 | Interventional | Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | N/A | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Patients with a cancellation or failure to show for a procedure or visit from March 9,
<br> 2020 through June 7, 2020 (90 days) and who have not rescheduled as of the date of
<br> randomization
<br>
<br> Exclusion Criteria:
<br>
<br> - Death
<br> | | Communication Research | Other: Communication type | Percent of Participants With Visit or Procedure With Provider | 28/10/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04418947 | Yes | False | | Yes |
| → | NCT04422613 | 14 June 2021→8 November 2021 | Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia | Characterization of Persistent Pulmonary Abnormalities Following COVID-19 Pneumonia | PULCO-19 | University Hospital, Toulouse | 05/06/2020 | 20200605 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04422613 | Not recruiting | No | 18 Years | N/A | All | May 28, 2020 | 73 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | France | | Elise Noël-Savina, MD | | | | University Hospital of Toulouse |
<br> Inclusion Criteria:
<br>
<br> - Patient with COVID-19 pneumonia
<br>
<br> - Positive PCR for COVID-19 on respiratory sample (saliva, nasopharyngeal, bronchial,
<br> tracheal aspiration or LBA)
<br>
<br> - Having required hospitalization in the pulmonology service, intensive care in
<br> pneumology or resuscitation service at the Toulouse University Hospital
<br>
<br> - Saturation <94% in ambient air at diagnosis
<br>
<br> - Patient having a chest CT-scan proving pneumonia during his hospitalization
<br>
<br> - Patient = 18 years old
<br>
<br> - Patient who has given written consent to participate in the study
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient hospitalized for pneumonia not documented by a chest CT-scan
<br>
<br> - Patient with negative COVID PCR
<br>
<br> - Patient known before the episode of COVID-19 pneumonia for a respiratory or cardiac
<br> pathology which can lead in itself to an alteration of gas exchanges
<br>
<br> - Patient under curators / guardianship
<br>
<br> - Pregnant patient
<br>
<br> - Minor patient
<br>
<br> - Absence of consent for participation in the study
<br>
<br> - Medical condition that does not allow for pulmonary function test
<br> | | Pneumonia, Viral | Diagnostic Test: pulmonary anomalies 4 months after documented COVID-19 pneumonia | Alteration of the DLCO | | | | Yes | False | | |
| → | NCT04434417 | 1 November 2021→8 November 2021 | Validation of an Immunochromatographic Assay for IgG/IgM Antibodies to 2019- nCoV | Clinical Validation of a Simple and Fast Immunochromatographic Assay for Qualitative Determination of Specific ImmunoGLObulin IgG/IgM Antibodies to 2019- nCoV in Whole bLood, Serum or Plasma Specimen | I-GLOBAL | European Institute of Oncology | 09/06/2020 | 20200609 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04434417 | Recruiting | No | 18 Years | N/A | All | April 15, 2020 | 1000 | Observational | | | Italy | ; ; | Giuseppe Curigliano, MD;Antonio Marra, MD;Atanasio Nonis, PhD | | ;;atanasio.nonis@ieo.it | ;;+390257489848 | European IO;European IO; |
<br> Inclusion Criteria:
<br>
<br> 1. Suspected cases who meet the following 2 criteria at the same time:
<br>
<br> 1. Epidemiological history: There was a history of contact with confirmed cases
<br> before the onset of illness; or subjects with at least one symptom in the last
<br> week before accrual in the trial. Subjects who have been in contact with people
<br> positive for SARS-CoV-2 in the previous 14 days.
<br>
<br> 2. Clinical manifestations are defined as :
<br>
<br> Fever >37.5°; dry cough, muscle pain and/or fatigue, anosmia, subjects with
<br> respiratory distress (Respiratory Rate >25/min or O2 Saturation <92%) or imaging
<br> characteristics of pneumonia; or the total number of white blood cells is normal or
<br> decreased with the lymphocyte count decreased in the early stage of onset or there is
<br> an abnormal C-Reactive protein. Other symptoms that clinical investigator will relate
<br> to SARS-CoV-2 infection. Subject or cancer patients who have been quarantined for
<br> suspect symptoms and have access to hospital to continue therapy or to receive major
<br> surgery
<br>
<br> 2. Confirmed cases, namely patients or subjects with positive Reverse
<br> Transcription-Polymerase Chain Reaction (RT-PCR) for SARS-CoV-2. On the basis of
<br> meeting the criteria for suspected cases, sputum, throat swabs, lower respiratory
<br> tract secretions, and other specimens are tested by realtime RT-PCR for positive
<br> nucleic acid detection of new coronavirus; or viral gene sequencing is highly
<br> homologous with known new coronaviruses. Patients positive are serially tested with
<br> SARS-CoV-2 lgM / IgG Rapid Test to evaluate the immune response in IgG negative
<br> patients and the reliability of the test in those patients who develop clinical signs
<br> of SARS-CoV-2 during the trial.
<br>
<br> 3. Patients who are considered at high risk for infection and eligible for active therapy
<br> and major surgery
<br>
<br> - Frailty (age and multiple comorbidities) planned to receive a standard systemic
<br> anticancer treatment comprising chemotherapy and/or immunotherapy and/or
<br> radiation therapy or to receive an experimental treatment
<br>
<br> - Major surgery or surgery after neoadjuvant chemotherapy and or chemo/radiotherapy
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Ascertained influenza virus, parainfluenza virus, adenovirus, respiratory syncytial
<br> virus, rhinovirus, human metapneumovirus, Severe Acute Respiratory Syndrome
<br> coronavirus, and other known other viral pneumonia;
<br>
<br> 2. Ascertained mycoplasma pneumoniae, chlamydia pneumonia, and bacterial pneumonia;
<br> non-infectious diseases such as vasculitis, dermatomyositis, and organizing pneumonia.
<br> | | COVID | Device: 2019-nCoV IgG/IgM Rapid Test Cassette | Interferon gamma quantification;Tumor Necrosis Factor (TNF) quantification;Interleukin-1 quantification;Interleukin-2 quantification;Interleukin-6 quantification;Evaluation of test accuracy;Evaluation of the rate of SARS-CoV-2 positive cancer patients and health professionals in a comprehensive cancer center or in a cancer setting. | | | | Yes | False | | |
| → | NCT04435379 | 1 November 2021→8 November 2021 | Study to Assess VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in COVID-19 Pandemic | A Phase III, Randomized, Double-blind, Placebo-controlled, Multicentre, Clinical Trial to Assess the Efficacy and Safety of VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in the SARS-CoV-2 Pandemic by Modulating the Immune System | | Vakzine Projekt Management GmbH | 16/06/2020 | 20200616 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04435379 | Not recruiting | No | 60 Years | N/A | All | June 18, 2020 | 2038 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor). | Phase 3 | Germany | | Leander Grode, Dr. rer. nat. | | | | Vakzine Projekt Management GmbH |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female adult (= 60 years)
<br>
<br> 2. Subject is contractually capable, able to understand information on study and has
<br> signed informed consent sheet
<br>
<br> 3. Subject has access to an internet-enabled electronic device
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Known active or latent Mycobacterium tuberculosis infection
<br>
<br> 2. Fever (> 38 °C) or respiratory tract infection within the past 24 hours
<br>
<br> 3. Current active viral or bacterial infection
<br>
<br> 4. Expected vaccination during the study period; vaccinations against influenza and
<br> pneumococcal disease are allowed with = 4 weeks between these vaccinations and the
<br> trial vaccination
<br>
<br> 5. Participation in another interventional study within 30 days before screening and
<br> during this study
<br>
<br> 6. Known hypersensitivity or allergy to (components of) the VPM1002 vaccine or serious
<br> adverse reactions to prior Bacille Calmette-Guérin (BCG) administration
<br>
<br> 7. Severely immunocompromised subjects, including:
<br>
<br> 1. subjects with known infection by the human immunodeficiency virus (HIV-1);
<br>
<br> 2. subjects with solid organ transplantation;
<br>
<br> 3. subjects with bone marrow transplantation;
<br>
<br> 4. subjects under chemotherapy, immunotherapy, or radiotherapy;
<br>
<br> 5. subjects with primary immunodeficiency;
<br>
<br> 6. treatment with any anti-cytokine therapies;
<br>
<br> 7. treatment with oral or intravenous steroids defined as daily doses of 10 mg
<br> prednisone or equivalent for longer than 3 months, or likely use of oral or
<br> intravenous steroids in the next 4 weeks;
<br>
<br> 8. History of malignancies, unless the subject has been free of the disease for = 2
<br> years; exception: subjects with adequately treated basal or squamous cell cancer or
<br> other localized non-melanoma skin cancer and adequately treated carcinoma in situ of
<br> the cervix may participate in the trial
<br>
<br> 9. Previous positive SARS-CoV-2 test result
<br>
<br> 10. Person is an employee of the sponsor, a relative of the sponsor or investigator, or is
<br> employed in the same department as the investigator
<br> | | Infection, Respiratory Tract | Biological: VPM1002;Biological: Placebo | Number of days with severe respiratory disease at hospital and/or at home | | | | Yes | False | | |
| → | NCT04444700 | 1 November 2021→8 November 2021 | A Pragmatic Randomized Controlled Trial of Therapeutic Anticoagulation Versus Standard Care as a Rapid Response to (SARS-CoV-2) COVID-19 Pandemic | Utilização da Enoxaparina em Dose Anticoagulante em Pacientes Hospitalizados Com síndrome respiratória Aguda Grave Por COVID-19 | RAPID-BRAZIL | University of Sao Paulo General Hospital | 22/06/2020 | 20200622 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04444700 | Not recruiting | No | 18 Years | N/A | All | July 4, 2020 | 465 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | Brazil | ; ; ; | Peter Juni, MD, FESC;Elnara M Negri, MD, PhD;Heraldo P de Souza, MD, PhD;Hassan Rahhal, MD | | ;;; | ;;; | St Michael's Hospital, Li Ka Shing Knowledge Institute, University of Toronto;Laboratório de Investigação Médica da FMUSP;Disciplina de Emergências Clínicas, Hospital das Clínicas da FMUSP;Disciplina de Emergências Clínicas, Hospital das Clínicas da FMUSP |
<br> The inclusion criteria are:
<br>
<br> 1. laboratory confirmed diagnosis of SARS-CoV-2 via reverse transcriptase polymerase
<br> chain reaction as per the World Health Organization protocol or by nucleic acid based
<br> isothermal amplification.Positive test prior to hospital admission OR within first 5
<br> days (i.e. 120 hours) after hospital admission;
<br>
<br> 2. admitted to hospital for COVID-19;
<br>
<br> 3. one D-dimer value above ULN (5 days (i.e. 120 hours) of hospital admission) and
<br> either: a) D-Dimer =2 times ULN; or b) D-dimer above ULN and oxygen saturation = 93%
<br> on room air;
<br>
<br> 4. =18 years of age;
<br>
<br> 5. informed consent from the patient (or legally authorized substitute decision maker).
<br>
<br> The exclusion criteria are:
<br>
<br> 1. pregnancy;
<br>
<br> 2. hemoglobin <80 g/L in the last 72 hours;
<br>
<br> 3. platelet count <50 x 10^9/L in the last 72 hours;
<br>
<br> 4. known fibrinogen <1.5 g/L (if testing deemed clinically indicated by the treating
<br> physician prior to the initiation of anticoagulation);
<br>
<br> 5. known INR >1.8 (if testing deemed clinically indicated by the treating physician prior
<br> to the initiation of anticoagulation);
<br>
<br> 6. patient already on intermediate dosing of LMWH that cannot be changed (determination
<br> of what constitutes an intermediate dose is to be at the discretion of the treating
<br> clinician taking the local institutional thromboprophylaxis protocol for high risk
<br> patients into consideration);
<br>
<br> 7. patient already on therapeutic anticoagulation at the time of screening (low or high
<br> dose nomogram UFH, LMWH, warfarin, direct oral anticoagulant (any dose of dabigatran,
<br> apixaban, rivaroxaban, edoxaban);
<br>
<br> 8. patient on dual antiplatelet therapy, when one of the agents cannot be stopped safely;
<br>
<br> 9. known bleeding within the last 30 days requiring emergency room presentation or
<br> hospitalization;
<br>
<br> 10. known history of a bleeding disorder of an inherited or active acquired bleeding
<br> disorder;
<br>
<br> 11. known history of heparin-induced thrombocytopenia;
<br>
<br> 12. known allergy to UFH or LMWH;
<br>
<br> 13. admitted to the intensive care unit at the time of screening;
<br>
<br> 14. treated with non-invasive positive pressure ventilation or invasive mechanical
<br> ventilation at the time of screening (of note: high flow oxygen delivery via nasal
<br> cannula is acceptable and is not an exclusion criterion).
<br>
<br> 15. imminent death according to the judgement of the most responsible physician
<br>
<br> 16. enrollment in another clinical trial of antithrombotic therapy involving pre-intensive
<br> care unit hospitalized patients
<br> | | COVID;Coronavirus Infection;Severe Acute Respiratory Syndrome;Thromboembolism, Venous;Anticoagulants and Bleeding Disorders | Drug: Therapeutic anticoagulation | Composite outcome of ICU admission (yes/no), non-invasive positive pressure ventilation (yes/no), invasive mechanical ventilation (yes/no), or all-cause death (yes/no) up to 28 days. | | | | Yes | False | | |
| → | NCT04449276 | 1 November 2021→8 November 2021 | A Study to Evaluate the Safety, Reactogenicity and Immunogenicity of Vaccine CVnCoV in Healthy Adults | COVID-19: A Phase 1, Partially Blind, Placebo-controlled, Dose Escalation, First-in-human, Clinical Trial to Evaluate the Safety, Reactogenicity and Immunogenicity After 1 and 2 Doses of the Investigational SARS-CoV-2 mRNA Vaccine CVnCoV Administered Intramuscularly in Healthy Adults | | CureVac AG | 18/06/2020 | 20200618 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04449276 | Not recruiting | No | 18 Years | 60 Years | All | June 18, 2020 | 280 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). | Phase 1 | Belgium;Germany;Belgium;Germany→Germany;Belgium;Germany;Belgium | | | | | | |
<br> Inclusion Criteria for all participants:
<br>
<br> - Healthy male and female participants aged 18 to 60 years inclusive. Healthy
<br> participant is defined as an individual who is in good general health, not having any
<br> mental or physical disorder requiring regular or frequent medication.
<br>
<br> - Expected to be compliant with protocol procedures and available for clinical follow-up
<br> through the last planned visit.
<br>
<br> - Physical examination and laboratory results without clinically significant findings
<br> according to the Investigator's assessment.
<br>
<br> - Body Mass Index (BMI) =18.0 and =30.0kg/m^2 (=18.0 and =32.0kg/m2 for participants
<br> with SARS-CoV-2 positive serology).
<br>
<br> - Females: At the time of enrollment, negative human chorionic gonadotropin (hCG)
<br> pregnancy test (serum) for women presumed to be of childbearing potential on the day
<br> of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (hCG), (only
<br> required if the serum pregnancy test was performed more than 3 days before).
<br>
<br> - Females of childbearing potential must use highly effective methods of birth control
<br> from 1 month before the first administration of the trial vaccine until 3 months
<br> following the last administration. The following methods of birth control are
<br> considered highly effective when used consistently and correctly:
<br>
<br> - Combined (estrogen and progestogen containing) hormonal contraception associated
<br> with inhibition of ovulation (oral, intravaginal or transdermal);
<br>
<br> - Progestogen-only hormonal contraception associated with inhibition of ovulation
<br> (oral, injectable or implantable);
<br>
<br> - Intrauterine devices (IUDs);
<br>
<br> - Intrauterine hormone-releasing systems (IUSs);
<br>
<br> - Bilateral tubal occlusion;
<br>
<br> - Vasectomized partner;
<br>
<br> - Sexual abstinence (periodic abstinence [e.g., calendar, ovulation, symptothermal
<br> and post-ovulation methods] and withdrawal are not acceptable).
<br>
<br> Exclusion Criteria:
<br>
<br> The following criterion applies to all open-label sentinel participants:
<br>
<br> - Participants with SARS-CoV-2 positive serology as confirmed by testing at enrollment.
<br>
<br> The following criteria apply to all participants, except those with SARS-CoV-2 positive
<br> serology:
<br>
<br> - Participants considered at the Investigator's discretion to be at increased risk to
<br> acquire COVID-19 disease (including, but not limited to, health care workers with
<br> direct involvement in patient care or care of long-term care recipients).
<br>
<br> - History of confirmed COVID-19 disease or known exposure to an individual with
<br> confirmed COVID-19 disease or SARS-CoV-2 infection within the past 2 weeks.
<br>
<br> The following criteria apply to all participants:
<br>
<br> - Use of any investigational or non-registered product (vaccine or drug) other than the
<br> trial vaccine within 28 days preceding the administration of the trial vaccine, or
<br> planned use during the trial period.
<br>
<br> - Receipt of any other vaccines within 14 days (for inactivated vaccines) or 28 days
<br> (for live vaccines) prior to enrollment in this trial or planned receipt of any
<br> vaccine within 28 days of trial vaccine administration.
<br>
<br> - Receipt of any investigational SARS-CoV-2 or other CoV vaccine prior to the
<br> administration of the trial vaccine.
<br>
<br> - Any treatment with immunosuppressants or other immune-modifying drugs within 6 months
<br> prior to the administration of the trial vaccine or planned use during the trial, with
<br> the exception of topically-applied steroids. Corticosteroids used in the context of
<br> COVID-19 disease of participants with SARS CoV 2 positive serology are not
<br> exclusionary.
<br>
<br> - Any medically diagnosed or suspected immunosuppressive or immunodeficient condition
<br> based on medical history and physical examination, including known human
<br> immunodeficiency virus infection, hepatitis B virus infection and hepatitis C virus
<br> infection.
<br>
<br> - History of a pIMD (potential immune-mediated disease).
<br>
<br> - History of angioedema.
<br>
<br> - Any known allergy, including allergy to any component of CVnCoV or aminoglycoside
<br> antibiotics. A history of hay fever or seasonal allergies (pollinosis) that does not
<br> require current treatment (e.g., anti-histamines) during the vaccination period (1
<br> month before first vaccination until 1 month after last vaccination) is not
<br> exclusionary.
<br>
<br> - History of or current alcohol and/or drug abuse.
<br>
<br> - Participants who are active smokers, were active smokers within the last year
<br> (including any vaping in the last year) or have a total smoking history =10 pack
<br> years.
<br>
<br> - Active or currently active SARS-CoV-2 infection as confirmed by reactive PCR within 3
<br> days of first trial vaccine administration.
<br>
<br> - History of confirmed SARS or MERS
<br>
<br> - Administration of immunoglobulins (Igs) and/or any blood products within the 3 months
<br> preceding the administration of any dose of the trial vaccine.
<br>
<br> - Presence or evidence of significant acute or chronic, medical or psychiatric illness.
<br> Significant medical or psychiatric illnesses include but are not limited to:
<br>
<br> - Respiratory disease (e.g., chronic obstructive pulmonary disease [COPD], asthma)
<br> requiring daily medications currently or any treatment of respiratory disease
<br> exacerbations (e.g., asthma exacerbation) in the last 5 years.
<br>
<br> - Respiratory disease with clinically significant dyspnea in the last 5 years
<br> (except COVID-19 disease in participants with SARS-CoV-2 positive serology).
<br>
<br> - Asthma medications: inhaled, oral, or intravenous (IV) corticosteroids,
<br> leukotriene modifiers, long- and short-acting beta agonists, theophylline,
<br> ipratropium, biologics.
<br>
<br> - Significant cardiovascular disease (e.g., congestive heart failure,
<br> cardiomyopathy, ischemic heart disease, history of stroke, peripheral artery
<br> disease, pulmonary embolism) or history of myocarditis or pericarditis as an
<br> adult.
<br>
<br> - Elevated blood pressure or hypertension, even if well-controlled.
<br>
<br> - Diabetes mellitus type 1 or 2.
<br>
<br> - History of any neurological disorders or seizures including Guillain-Barré
<br> syndrome, with the exception of febrile seizures during childhood.
<br>
<br> - Current or past malignancy, unless completely resolved without sequelae for >5
<br> years.
<br>
<br> - Foreseeable non-compliance with protocol as judged by the Investigator.
<br>
<br> - For females: pregnancy or lactation.
<br>
<br> - History of any anaphylactic reactions.
<br>
<br> - Part | | Severe Acute Respiratory Syndrome;Coronavirus;SARS-CoV-2;COVID-19 | Biological: CVnCoV Vaccine;Drug: Placebo | Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 24 Hours After the First Vaccination;Number of Participants With Grade 3 Adverse Reactions or any Serious Adverse Event (SAE) Considered Related to Trial Vaccine Within at Least 60 Hours After the First Vaccination;Number of Participants with Solicited Local Adverse Events;Intensity of Solicited Local Adverse Events per the FDA Toxicity Grading Scale;Duration of Solicited Local Adverse Events;Number of Participants with Solicited Systemic Adverse Events;Intensity of Solicited Systemic Adverse Events per the FDA Toxicity Grading Scale;Duration of Solicited Systemic Adverse Events;Number of Participants with Solicited Systemic Adverse Events Considered Related to Trial Vaccine;Number of Participants with Unsolicited Adverse Events;Intensity of Unsolicited Adverse Events Assessed by the Investigator;Number of Participants with Unsolicited Adverse Events Considered Related to Trial Vaccine;Number of Participants with One or More Serious Adverse events (SAEs);Number of Participants with One or More Serious Adverse events (SAEs) Considered Related to Trial Vaccine;Number of Participants with One or More Adverse Events of Special Interest (AESIs);Number of Participants with One or More Adverse Events of Special Interest (AESIs) Considered Related to Trial Vaccine | | | | Yes | False | | |
| → | NCT04459247 | 19 April 2021→8 November 2021 | Short Term, High Dose Vitamin D Supplementation for COVID-19 | Short Term, High Dose Vitamin D Supplementation for COVID-19 Disease: Double Blind, Controlled, Study | SHADE | Postgraduate Institute of Medical Education and Research | 03/07/2020 | 20200703 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04459247 | Not recruiting | No | 18 Years | N/A | All | June 15, 2020 | 30→40 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider). | N/A | India | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - SARS-CoV-2 RNA positive Asymptomatic individuals
<br>
<br> Exclusion Criteria:
<br>
<br> - Uncontrolled Diabetes Uncontrolled Hypertension Chronic Liver Disease Chronic
<br> obstructive Pulmonary disease Requiring Invasive Ventilation
<br> | | COVID | Drug: Vit D | Virus negativity | | | | Yes | False | | |
| → | NCT04459286 | 16 February 2021→8 November 2021 | The Nitazoxanide Plus Atazanavir for COVID-19 Study | A Randomized, Open Label Trial to Investigate the Efficacy and Safety of Nitazoxanide Plus Atazanavir/Ritonavir for the Treatment of COVID-19: a Pilot Study | NACOVID | Obafemi Awolowo University | 03/07/2020 | 20200703 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04459286 | Recruiting→Not recruiting | Yes | 18 Years | 75 Years | All | October 9, 2020 | 98→57 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | Phase 2 | Nigeria | ␣→ | Adeniyi Olagunju, PhD→ | | aeolagunju@oauife.edu.ng→ | +2349068858698→ | |
<br> Inclusion Criteria:
<br>
<br> - Willingness and ability to provide written informed consent
<br>
<br> - At least 18 and not more than 75 years of age at study entry
<br>
<br> - SARS-CoV-2 infection confirmed by PCR test within 4 days before randomization
<br>
<br> - Currently symptomatic (fever or chills, cough, myalgia, sore throat, shortness of
<br> breath, or new onset of anosmia or ageusia) and at COVID-19 isolation and treatment
<br> centre
<br>
<br> Exclusion Criteria:
<br>
<br> - Inability to take orally administered medication or food
<br>
<br> - Known hypersensitivity to study medication
<br>
<br> - Pregnant or lactating (unless practicing exclusive replacement feeding for the entire
<br> study duration)
<br>
<br> - Participation in any other interventional trial for COVID-19 (observational study
<br> co-enrollment allowed)
<br>
<br> - Concurrent treatment with other agents with actual or possible direct-acting antiviral
<br> activity against SARS-CoV-2 less than 24 hours prior to study drug dosing
<br>
<br> - Concurrent use of agents with known or uncertain interaction with study drugs,
<br> including ritonavir
<br>
<br> - Requiring mechanical ventilation at screening
<br>
<br> - Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) above 5 times upper
<br> limit of normal (ULN)
<br>
<br> - Creatinine clearance below 50 mL/min using the Cockcroft-Gault formula for
<br> participants above 18 years of age
<br> | | Covid-19 | Drug: Nitazoxanide and atazanavir/ritonavir;Other: Standard of Care | Difference in SARS-CoV-2 AUC;Time to SARS-CoV-2 negativity;Time to clinical improvement→Time to clinical improvement;Time to SARS-CoV-2 negativity;Difference in SARS-CoV-2 AUC | | | | Yes | True | parent | |
| → | NCT04460703 | 12 December 2020→8 November 2021 | COVID-19 Vaccine Messaging, Part 1 | Persuasive Messages for COVID-19 Vaccine Uptake: a Randomized Controlled Trial, Part 1 | | Yale University | 02/07/2020 | 20200702 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04460703 | Not recruiting | No | 18 Years | N/A | All | July 3, 2020 | 4000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: None (Open Label). | N/A | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - At least 18 years of age
<br>
<br> - US resident
<br>
<br> Exclusion Criteria:
<br>
<br> - Younger than 18 years of age
<br>
<br> - Non-US resident
<br>
<br> - Do not consent
<br> | | Vaccination;COVID-19 | Other: Control message;Other: Baseline message;Other: Personal freedom message;Other: Economic freedom message;Other: Self-interest message;Other: Community interest message;Other: Economic benefit message;Other: Guilt message;Other: Embarrassment message;Other: Anger message;Other: Trust in science message;Other: Not bravery message | Intention to get COVID-19 vaccine | | | | Yes | False | | |
| → | NCT04468087 | 7 June 2021→8 November 2021 | Antiviral Agents Against COVID-19 Infection | Antiviral for Adult Patients Hospitalized for SARS-CoV-2 Infection: a Randomized, Phase 2/3, Multicenter, Placebo Controlled, Adaptive, Multi-arm, Multi-stage Clinical Trial - Coalition Brazil COVID-19 IX: REVOLUTIOn | REVOLUTIOn | Hospital do Coracao | 03/07/2020 | 20200703 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04468087 | Recruiting | No | 18 Years | 90 Years | All | February 15, 2021 | 1005 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | Brazil | ; ; | Israel S Maia, MSc;Israel Maia, MSc;Alexandre B Cavalcanti, MD, PhD | | ;ismaia@hcor.com.br;abiasi@hcor.com.br→;ismaia@ext.hcor.com.br;abiasi@hcor.com.br | ;11 +55113053 6611;+55 11 30536611 | HCor Research Institute; |
<br> Inclusion Criteria:
<br>
<br> 1. Adults (= 18 years) hospitalized with COVID-19:
<br>
<br> - SARS-CoV-2 positive RT-PCR or Antigen test
<br>
<br> - Typical clinical history and chest CT with typical findings, pending RT-PCR for
<br> SARS-CoV-2
<br>
<br> 2. Symptom duration <= 9 days
<br>
<br> 3. SpO2 <= 94% in room air or need for supplemental oxygen to maintain SpO2> 94%
<br>
<br> 4. The patient consents to participate in the study and is willing to comply with all
<br> study procedures, including the collection of virology samples
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients in need of respiratory support with CNAF, NIV or invasive mechanical
<br> ventilation;
<br>
<br> 2. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit
<br> of normal;
<br>
<br> 3. Total bilirubin > 2 mg/dL;
<br>
<br> 4. Platelets <50,000 cel/L;
<br>
<br> 5. Total neutrophil count <750 cell/L;
<br>
<br> 6. Renal dysfunction (estimated glomerular filtration rate [eGFR] <30 mL / min / 1.73 m2,
<br> using the MDRD or CKD-EPI method); and pre-defined renal failure stage 3 according to
<br> AKINx classification with serum creatinine> 4 mg / dl or patient already on renal
<br> replacement therapy;
<br>
<br> 7. Previously known liver disease (liver cirrhosis), defined as a report by the
<br> participant or written in the respective cirrhosis chart, esophageal varices, or the
<br> presence of clinical ascites on examination;
<br>
<br> 8. Decompensated congestive heart failure defined as the presence of dyspnea, edema of
<br> the lower limbs or rales on pulmonary auscultation, jugular turgency or chest X-ray
<br> with signs of pulmonary congestion;
<br>
<br> 9. Pregnant or lactating patients;
<br>
<br> 10. Known allergy or hypersensitivity to any study drug;
<br>
<br> 11. Hepatitis C carrier (HCV RNA positive), active Hepatitis B (positive surface antigen
<br> in the past), or HIV (ELISA and confirmatory Western Blot in the past). New screening
<br> tests are NOT required;
<br>
<br> 12. Patients currently using nucleoside or nucleotide analog drugs for any indication;
<br>
<br> 13. Corrected Q interval T> 480 on the electrocardiogram;
<br>
<br> 14. Heart rate <55 bpm;
<br>
<br> 15. Patients in use or who recently used (<90 days) amiodarone;
<br>
<br> 16. Women of childbearing potential and men with a partner of childbearing potential who
<br> do NOT agree to use two contraceptive methods (including barrier method) for 100 days.
<br> →
<br> Inclusion Criteria:
<br>
<br> 1. Adults (= 18 years) hospitalized with COVID-19:
<br>
<br> - SARS-CoV-2 positive RT-PCR or Antigen test
<br>
<br> - Typical clinical history and chest CT with typical findings, pending RT-PCR for
<br> SARS-CoV-2
<br>
<br> 2. Symptom duration <= 9 days
<br>
<br> 3. SpO2 <= 94% in room air or need for supplemental oxygen to maintain SpO2> 94%
<br>
<br> 4. The patient consents to participate in the study and is willing to comply with all
<br> study procedures, including the collection of virology samples
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients in need of respiratory support with invasive mechanical ventilation;
<br>
<br> 2. Alanine Transaminase (ALT) or Aspartate Transaminase (AST) > 5 times the upper limit
<br> of normal;
<br>
<br> 3. Total bilirubin > 2 mg/dL;
<br>
<br> 4. Platelets <50,000 cel/L;
<br>
<br> 5. Total neutrophil count <750 cell/L;
<br>
<br> 6. Renal dysfunction (estimated glomerular filtration rate [eGFR] <30 mL / min / 1.73 m2,
<br> using the MDRD or CKD-EPI method); and pre-defined renal failure stage 3 according to
<br> AKINx classification with serum creatinine> 4 mg / dl or patient already on renal
<br> replacement therapy;
<br>
<br> 7. Previously known liver disease (liver cirrhosis), defined as a report by the
<br> participant or written in the respective cirrhosis chart, esophageal varices, or the
<br> presence of clinical ascites on examination;
<br>
<br> 8. Decompensated congestive heart failure defined as the presence of dyspnea, edema of
<br> the lower limbs or rales on pulmonary auscultation, jugular turgency or chest X-ray
<br> with signs of pulmonary congestion;
<br>
<br> 9. Pregnant or breast feeding patients;
<br>
<br> 10. Known allergy or hypersensitivity to any study drug;
<br>
<br> 11. Hepatitis C carrier (HCV RNA positive), active Hepatitis B (positive surface antigen
<br> in the past), or HIV (ELISA and confirmatory Western Blot in the past). New screening
<br> tests are NOT required;
<br>
<br> 12. Patients currently using nucleoside or nucleotide analog drugs for any indication;
<br>
<br> 13. Corrected Q interval T> 480 on the electrocardiogram;
<br>
<br> 14. Heart rate <55 bpm;
<br>
<br> 15. Patients in use or who recently used (<90 days) amiodarone;
<br>
<br> 16. Women of childbearing potential and men with a partner of childbearing potential who
<br> do NOT agree to use two contraceptive methods (including barrier method) for 100 days.
<br> | | COVID-19 | Drug: Atazanavir;Drug: Daclatasvir 60 mg;Drug: Sofusbuvir + Daclastavir 60 mg;Drug: Placebo Atazanavir;Drug: Placebo Daclatasvir 60 mg;Drug: Placebo Sofusbuvir + Daclatasvir 60 mg | Phase III: Number of free days from respiratory support;Phase II second step: Change in the slope of SARS-COV 2 viral load;Phase II first step: Change in the slope of SARS-COV 2 viral load | | | | Yes | False | | |
| → | NCT04468958 | 1 November 2021→8 November 2021 | Safety, Tolerability, and Pharmacokinetics of SAB-185 in Healthy Participants | A Phase 1, Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study of SAB-185 in Healthy Subjects | | SAb Biotherapeutics, Inc. | 08/07/2020 | 20200708 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04468958 | Not recruiting | No | 18 Years | 60 Years | All | August 5, 2020 | 28 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1 | United States | | David Hoover, MD | | | | ICON GPHS |
<br> Inclusion Criteria:
<br>
<br> Subjects must meet all of the following criteria for inclusion:
<br>
<br> 1. 18-60 years of age
<br>
<br> 2. Able to understand the study and comply with all study procedures
<br>
<br> 3. Agrees not to participate in any other trial of an investigational product during the
<br> study period
<br>
<br> 4. Willing and able to provide written informed consent prior to the start of any study
<br> related activities
<br>
<br> 5. In good health in the opinion of the site principal investigator as determined by
<br> vital signs, medical history, physical examination and clinical laboratory tests
<br>
<br> 6. If female, meets at least one of the following reproductive risk criteria
<br>
<br> - Post-menopausal for at least 12 months
<br>
<br> - Use of one or more of the following highly effective contraceptive methods for at
<br> least 90 days following the last dose of study product: combined estrogen and
<br> progestogen containing or progestogen-only hormonal contraception, intrauterine
<br> device (IUD), intrauterine hormone-releasing system, surgical bilateral tubal
<br> occlusion
<br>
<br> - Vasectomized sole sexual partner who has received medical assessment of the
<br> surgical success
<br>
<br> 7. Subjects agree to sexual abstinence (refraining from heterosexual intercourse for at
<br> least 90 days following the last dose of study product) if not using birth control or
<br> condoms for males.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Female subjects with positive pregnancy test, breastfeeding, or planning to become
<br> pregnant/breastfeed during the study period.
<br>
<br> 2. Treatment or participation in another clinical trial of any other investigational
<br> agent within 30 days prior to enrollment.
<br>
<br> 3. Use of other drugs that, in the opinion of the investigator, could complicate analysis
<br> of SAB-185.
<br>
<br> 4. Subjects with the following risk factors:
<br>
<br> - Compromised immune system including confirmed diagnosis of current cancer under
<br> treatment, inherited deficiencies of the immune system, immune suppressing
<br> medication, or other conditions causing leukopenia or neutropenia
<br>
<br> - Known autoimmune condition requiring therapy more intensive than intermittent
<br> non-steroidal anti-inflammatories in the prior 6 months (for example: rheumatoid
<br> arthritis, lupus, inflammatory bowel disease)
<br>
<br> - Chronic respiratory disease including COPD, emphysema, cystic fibrosis, pulmonary
<br> hypertension, or other chronic condition that requires the routine use of
<br> supplemental oxygen
<br>
<br> - Chronic asthma requiring the use of oral steroids or hospitalization in the last
<br> six months
<br>
<br> - Renal failure or renal insufficiency requiring dialysis
<br>
<br> - Congestive heart failure or significant atherosclerotic disease (coronary artery
<br> disease or peripheral vascular disease)
<br>
<br> - Hypertension, diabetes, those currently vaping or smoking or with a history of
<br> chronic smoking, and those with BMI > 35 kg/m2
<br>
<br> 5. Receipt of pooled immunoglobulin or plasma in past 30 days
<br>
<br> 6. Any other underlying medical (cardiac, liver, renal, neurological, respiratory) or
<br> psychiatric condition that in the view of the investigator would preclude use of
<br> SAB-185
<br>
<br> 7. Known IgA deficiency or previous allergic reaction to intravenous immunoglobin
<br> (IVIG)/subcutaneous immunoglobin (SCIG)
<br>
<br> 8. Positive screening test for hepatitis B virus surface antigen, hepatitis C virus
<br> antibody, or HIV antibody
<br>
<br> 9. Positive screening test for rheumatoid factor
<br>
<br> 10. History of COVID-19
<br>
<br> 11. Positive FDA-authorized screening test for serum SARS-CoV-2 antibody or presence of
<br> SARS-CoV-2 on nasopharyngeal or oropharyngeal swab by FDA-authorized RT-PCR
<br>
<br> 12. History of allergy, anaphylaxis, or severe reaction to beef products (including milk
<br> and gelatin).
<br> | | COVID-19;SARS-CoV2 | Biological: SAB-185;Other: Normal saline | Number of Participants Having Adverse Events;Number of Participants Having Transfusion-Related Adverse Events | | | | Yes | False | | |
| → | NCT04469179 | 1 November 2021→8 November 2021 | Safety, Tolerability, and Pharmacokinetics of SAB-185 in Ambulatory Participants With COVID-19 | A Phase 1B, Randomized, Double-Blind, Placebo-Controlled, Single Ascending Dose Study of SAB-185 in Ambulatory Subjects With COVID-19 | | SAb Biotherapeutics, Inc. | 08/07/2020 | 20200708 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04469179 | Not recruiting | No | 18 Years | 60 Years | All | August 20, 2020 | 21 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1 | United States | | David Hoover, MD | | | | ICON GPHS |
<br> Inclusion Criteria:
<br>
<br> Subjects must meet all of the following criteria for inclusion:
<br>
<br> 1. 18-60 years of age
<br>
<br> 2. Positive for presence of SARS-CoV-2 on NP or OP swab by FDA-authorized RT-PCR test
<br> within seven days prior to infusion
<br>
<br> 3. At least one current symptom of COVID-19, onset within seven days prior to infusion:
<br>
<br> - Fever or chills
<br>
<br> - Cough
<br>
<br> - Shortness of breath or difficulty breathing
<br>
<br> - Fatigue
<br>
<br> - Muscle or body aches
<br>
<br> - Headache
<br>
<br> - New loss of taste or smell
<br>
<br> - Sore throat
<br>
<br> - Congestion or runny nose
<br>
<br> - Nausea or vomiting
<br>
<br> - Diarrhea
<br>
<br> 4. Able to understand the study and comply with all study procedures
<br>
<br> 5. Agrees not to participate in any other trial of an investigational product during the
<br> study period
<br>
<br> 6. Willing and able to provide written informed consent prior to the start of any study
<br> related activities
<br>
<br> 7. If female, meets at least one of the following reproductive risk criteria
<br>
<br> - Post-menopausal for at least 12 months
<br>
<br> - Use of one or more of the following highly effective contraceptive methods for at
<br> least 90 days following the last dose of study product: combined estrogen and
<br> progestogen containing or progestogen-only hormonal contraception, intrauterine
<br> device (IUD), intrauterine hormone-releasing system, surgical bilateral tubal
<br> occlusion
<br>
<br> - Vasectomized sole sexual partner who has received medical assessment of the
<br> surgical success
<br>
<br> 8. Male and female subjects agree to sexual abstinence (refraining from heterosexual
<br> intercourse for at least 90 days following the last dose of study product) if not
<br> using birth control or condoms for males.
<br>
<br> Exclusion Criteria:
<br>
<br> Subjects who meet any of the criteria of severe or higher COVID-19 will be excluded from
<br> the study:
<br>
<br> - Dyspnea at rest
<br>
<br> - Respiratory rate > 30 breaths per minute
<br>
<br> - SpO2 = 93% on room air
<br>
<br> - Heart rate = 125 beats per minute
<br>
<br> - Respiratory distress or respiratory failure.
<br>
<br> - Evidence of critical illness
<br>
<br> 1. Female subjects with positive pregnancy test, breastfeeding, or planning to
<br> become pregnant/breastfeed during the study period.
<br>
<br> 2. Hospitalization or need for hospitalization for any cause
<br>
<br> 3. Treatment or participation in another clinical trial of any other investigational
<br> agent within 30 days prior to enrollment.
<br>
<br> 4. Use of other drugs that, in the opinion of the investigator, could complicate
<br> analysis of SAB-185.
<br>
<br> 5. Subjects with the following risk factors:
<br>
<br> - Compromised immune system including confirmed diagnosis of current cancer under
<br> treatment, inherited deficiencies of the immune system, immune suppressing medication,
<br> or other conditions causing leukopenia or neutropenia
<br>
<br> - Known autoimmune condition requiring therapy more intensive than intermittent
<br> non-steroidal anti-inflammatories in the prior 6 months (for example: rheumatoid
<br> arthritis, lupus, inflammatory bowel disease)
<br>
<br> - Chronic respiratory disease including COPD, emphysema, cystic fibrosis, pulmonary
<br> hypertension, or other chronic condition that requires the routine use of supplemental
<br> oxygen
<br>
<br> - Chronic asthma requiring the use of oral steroids or hospitalization in the last six
<br> months
<br>
<br> - Renal failure or renal insufficiency requiring dialysis
<br>
<br> - Congestive heart failure or significant atherosclerotic disease (coronary artery
<br> disease or peripheral vascular disease) 6. Receipt of pooled immunoglobulin or plasma
<br> in past 30 days 7. Any other underlying medical (cardiac, liver, renal, neurological,
<br> respiratory) or psychiatric condition that in the view of the investigator would
<br> preclude use of SAB-185 8. Known IgA deficiency or previous allergic reaction to
<br> intravenous immunoglobin (IVIG)/subcutaneous immunoglobin (SCIG) 9. Positive for
<br> hepatitis B virus surface antigen, hepatitis C virus antibody, or HIV antibody by
<br> medical history 10. History of allergy, anaphylaxis, or severe reaction to beef
<br> products (including milk and gelatin).
<br> | | COVID-19;SARS-CoV2 | Biological: SAB-185;Other: Normal Saline | Number of Participants Having Adverse Events;Number of Participants Having Transfusion-Related Adverse Events | | | | Yes | False | | |
| → | NCT04472494 | 17 August 2021→8 November 2021 | Study of Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise | Phase 2, Randomized, Double-Blind Placebo Controlled Study of Intravenous Abatacept in the Treatment of Hospitalized COVID-19 Participants With Respiratory Compromise | | Bristol-Myers Squibb | 14/07/2020 | 20200714 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04472494 | Not recruiting | No | 18 Years | N/A | All | October 14, 2020 | 61 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | United States;Puerto Rico;United States | | Bristol-Myers Squibb | | | | Bristol-Myers Squibb |
<br> For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
<br> visit www.BMSStudyConnect.com
<br>
<br> Inclusion Criteria:
<br>
<br> - A confirmed virological diagnosis of severe acute respiratory syndrome coronavirus 2
<br> (SARS-CoV-2) infection (by reverse-transcription polymerase chain reaction (RT-PCR)).
<br>
<br> - Hospitalized (or in the Emergency Department awaiting a bed after hospitalization)
<br>
<br> - Respiratory compromise as defined by requirement of oxygen supplementation to maintain
<br> oxygen saturation = 93% but not requiring mechanical ventilation
<br>
<br> - Abnormal chest X-ray consistent with COVID-19 and not indicating other serious medical
<br> condition that would serve as an exclusionary criteria
<br>
<br> - Women and men must agree to follow specific methods of contraception, if applicable
<br>
<br> Exclusion Criteria:
<br>
<br> - Women who are breastfeeding
<br>
<br> - Recent acute infection defined as:
<br>
<br> i) Any acute infection within 60 days prior to randomization that required
<br> hospitalization or treatment with parenteral antibiotics (not COVID-19 related) ii)
<br> Any acute infection within 30 days prior to randomization that required oral
<br> antimicrobial or antiviral therapy
<br>
<br> - History of chronic or recurrent bacterial infection (e.g., chronic pyelonephritis,
<br> osteomyelitis, bronchiectasis)
<br>
<br> - Prior exposure to BMS-188667 (abatacept)
<br>
<br> Other protocol-defined inclusion/exclusion criteria apply
<br> | | COVID-19;SARS-CoV-2 | Biological: Abatacept;Other: Placebo | Proportion of participants with composite end point of mechanical ventilation or death prior to or on Day 28 | | | | Yes | False | | |
| → | NCT04477473 | 12 December 2020→8 November 2021 | Perceived Impact of the COVID-19 Pandemic on Medical Management and Symptoms in a High Risk Group | Perceived Impact of the COVID-19 Pandemic on Medical Management and Symptoms in a High Risk Group: Patients Under Long Term Noninvasive Ventilation for Chronic Hypercapnic Respiratory Failure in Geneva. An Observational Monocentric Study | | University Hospital, Geneva | 17/07/2020 | 20200717 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04477473 | Recruiting→Not recruiting | No | 18 Years | 100 Years | All | June 30, 2020 | 100→66 | Observational | | | Switzerland | ; ; → | Jean-Paul Janssens, M.D;Jean-Paul Janssens, M.D;Jean-Paul Janssens, M.D.→Jean-Paul Janssens, M.D | | ;jean-paul.janssens@hcuge.ch;Jean-Paul.Janssens@hcuge.ch→ | ;+41.22.372.95.46;+41.22.372.95.46→ | University Hospital, Geneva;→University Hospital, Geneva |
<br> Inclusion Criteria:
<br>
<br> - Patients followed by the Division of Pulmonology of Geneva University Hospitals with
<br> home NIV
<br>
<br> - Aged above 18 years of age
<br>
<br> - Stable clinical condition
<br>
<br> Exclusion Criteria:
<br>
<br> - Age below 18 years of age
<br>
<br> - Unwillingness to participate
<br>
<br> - Unstable clinical condition
<br> | | COVID-19 Pandemic;Vulnerable Subjects;Long-term Non-invasive Ventilation | Other: Questionnaire-based observational study | Questionnaire | | | | Yes | False | | |
| → | NCT04482686 | 1 November 2021→8 November 2021 | Trial of Combination Therapy to Treat COVID-19 Infection | A Phase I Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection | | ProgenaBiome | 21/07/2020 | 20200721 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04482686 | Not recruiting | No | 18 Years | N/A | All | December 9, 2020 | 31 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2→Phase 1 | United States | ; | Sabine Hazan, MD;Thomas Borody, MD | | ; | ; | ProgenaBiome;Topelia Therpeutics |
<br> Inclusion Criteria:
<br>
<br> 1. Signed informed consent, demonstrating that the subject understands the procedures
<br> required for the study and the purpose of the study
<br>
<br> 2. Healthy male or female subjects at least 18 years of age
<br>
<br> 3. Diabetic and obese (BMI > 30) patients will be included in the Trial but randomization
<br> will be stratified.
<br>
<br> 4. Positive test for COVID-19 by RT-PCR or rapid antigen test at screening
<br>
<br> 5. Subjects must agree to practice at least two highly effective methods of birth control
<br> for the duration of the study. One of these must be a barrier method. Exceptions for
<br> females and partners of females that are not of childbearing potential. (e.g.
<br> surgically sterilized, post-menopausal)
<br>
<br> 6. Subjects must agree they will attend the treatment facility daily for 10d in the event
<br> of failure to attend, the patient will be visited at their home to collect the nasal
<br> swab and review data.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Refusal to sign informed consent form
<br>
<br> 2. Negative test for COVID-19 by RT-PCR at screening
<br>
<br> 3. Severe disease symptomatically including pneumonia, respiratory distress, tachypnea,
<br> shortness of breath, temperature > 104.0 degrees F, pleuritic pain, or frequent cough.
<br>
<br> 4. Known drug allergy to any of the investigational medications
<br>
<br> 5. Currently taking medication with known drug interactions with investigational
<br> medications, found in Appendix II
<br>
<br> 6. Prescription or other antiviral medications
<br>
<br> 7. Any comorbidities which constitute health risk for the subject including known cardiac
<br> arrhythmias - but will be limited to those on hydroxychloroquine
<br>
<br> 8. Inability to attend daily for 10 days
<br> | | COVID;Covid-19;Corona Virus Infection;Coronavirus Infection;Coronavirus-19;SARS-CoV2;SARS-CoV Infection | Drug: Ivermectin;Drug: Doxycycline Hcl;Dietary Supplement: Zinc;Dietary Supplement: Vitamin D3;Dietary Supplement: Vitamin C | Time to Non-Infectivity by RT-PCR;Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score);Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score);Efficacy of Treatment as measured by Titer;Efficacy of Treatment as measured by RT-PCR→Efficacy of Treatment as measured by RT-PCR;Efficacy of Treatment as measured by Titer;Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score);Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score);Time to Non-Infectivity by RT-PCR | | | | Yes | False | | |
| → | NCT04484207 | 1 November 2021→8 November 2021 | Addressing COVID-19 Mental Health Problems Among US Veterans | Addressing COVID-19 Mental Health Problems Among US Veterans | | Research Foundation for Mental Hygiene, Inc. | 21/07/2020 | 20200721 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04484207 | Not recruiting | No | 18 Years | 80 Years | All | July 6, 2020 | 172 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Single (Participant). | N/A | United States | | Yuval Neria Neria, PhD | | | | Columbia University and NYSPI |
<br> Inclusion Criteria:
<br>
<br> - English speakers, veterans (military experience) aged 18-80, US residents
<br>
<br> Exclusion Criteria:
<br>
<br> - non-English speakers, age less than 18 or more than 80
<br> | | Brief Video-based Intervention;Vignette Based Intervention;Non Intervention Control Arm | Other: A short video intervention;Other: A vignette intervention | Help Seeking Intention | 28/10/2021 | | https://clinicaltrials.gov/ct2/show/results/NCT04484207 | Yes | False | | Yes |
| → | NCT04488575 | 8 February 2021→8 November 2021 | Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With COVID-19 Infection | A Phase 2 Double-blind Placebo-controlled Study Investigating the Safety and Efficacy of EDP1815 in the Treatment of Patients Hospitalized With SARS-CoV-2 Infection | | Evelo Biosciences, Inc. | 23/07/2020 | 20200723 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04488575 | Recruiting→Not recruiting | No | 18 Years | N/A→65 Years | All | August 26, 2020 | 60→16 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). | Phase 2 | United States | ; ; → ; | Reynold Panettieri, MD;Douglas Maslin, MD;Daniela Walker→Reynold Panettieri, MD;Douglas Maslin, MD | | ;;clinicaltrials@evelobio.com→; | ;;6175770300→; | Rutgers, The State University of New Jersey;Evelo Biosciences;→Rutgers, The State University of New Jersey;Evelo Biosciences |
<br> Key Inclusion Criteria:
<br>
<br> 1. Hospitalized within the last 36 hours.
<br>
<br> 2. Receiving any form of supplementary oxygen therapy at baseline.
<br>
<br> 3. Confirmed COVID-19 viral infection by RTPCR at screening.
<br>
<br> 4. Age:
<br>
<br> 1. 18-65 years old, OR
<br>
<br> 2. >65 year-olds can be included after DMC approval
<br>
<br> Key Exclusion Criteria:
<br>
<br> 1. Contraindications/hypersensitivity to P histicola or any of the capsule excipients
<br>
<br> 2. Patients with chronic hypoxia or underlying significant chronic respiratory disease
<br> (such as COPD, Pulmonary Fibrosis, or Bronchiectasis).
<br>
<br> 3. Admission to ICU at time of screening.
<br>
<br> 4. Mechanically ventilated, on CPAP, or on non-invasive ventilation at the time of
<br> screening.
<br>
<br> 5. Patient is taking a systemic immunosuppressive agent such as, but not limited to, oral
<br> steroids, methotrexate, azathioprine, ciclosporin, or tacrolimus, unless these are
<br> given as part of COVID standard of care treatment.
<br>
<br> 6. Patient has a diagnosed primary immunodeficiency.
<br>
<br> 7. Patient has a diagnosis of HIV/AIDS
<br>
<br> 8. Patient has pre-existing known chronic kidney disease stage 4 or 5 or requiring renal
<br> replacement therapy (i.e. estimated glomerular filtration rate (eGFR)
<br> <30ml/min/1.73m2)
<br>
<br> 9. Patient has pre-existing known significant liver disease with Alanine aminotransferase
<br> (ALT) or aspartate aminotransferase (AST) = 5.0 x upper limit of normal (ULN)
<br>
<br> 10. Patient has pre-existing known significant gastrointestinal tract disease expected to
<br> affect absorption within the small intestine (e.g. short bowel syndrome, inflammatory
<br> bowel disease affecting the small intestine, gastroparesis); or prior malabsorptive
<br> bariatric surgery that could interfere with GI delivery and transit time.
<br>
<br> 11. GI signs or symptoms equivalent to CTCAE v5.0, gastrointestinal disorders, grade 3 or
<br> 4 event.
<br>
<br> 12. Patient has pre-existing known substantially impaired cardiac function or pre-existing
<br> clinically significant cardiac diseases, including unstable angina or acute myocardial
<br> infarction = 6 weeks prior to Screening.
<br>
<br> 13. Currently participating in an interventional clinical trial (observational studies
<br> allowed).
<br>
<br> 14. Moribund at time of screening
<br> | | Covid19 | Drug: EDP1815;Drug: Placebo | Change from baseline to the lowest S/F oxygen ratio | | | | Yes | False | | |
| → | NCT04492891 | 1 November 2021→8 November 2021 | Cyclosporine For The Treatment Of COVID-19(+) | Randomized Phase IIa Clinical Trial Of Cyclosporine For The Treatment Of COVID-19(+) Non-ICU Hospital Inpatients | | Bryan Burt, MD | 20/07/2020 | 20200720 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04492891 | Recruiting | No | 18 Years | 90 Years | All | November 23, 2020 | 75 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | ; ; | Bryan Burt, MD;Michelle Almarez, BBA;Michelle Almarez, BBA | | ;malmarez@bcm.edu; | ;713-798-3680;713-798-3680 | Baylor College of Medicine; |
<br> Inclusion Criteria:
<br>
<br> 3.1.1 Laboratory-confirmed SARS-CoV-2 infection within the past 10 days.
<br>
<br> 3.1.2 Patients admitted to non-ICU hospital floors or in an emergency department awaiting
<br> admission to a non-ICU hospital bed.
<br>
<br> 3.1.3 WHO COVID Scale Score 4 (Oxygen by mask or nasal prongs or WHO COVID Scale Score 5
<br> (non-invasive ventilation or high-flow oxygen).
<br>
<br> 3.1.4 Age 18 to 90 years old.
<br>
<br> 3.1.5 ECOG (Eastern Cooperative Oncology Group) performance status =2 (see Appendix A).
<br>
<br> 3.1.6 Patients receiving or who have received standard of care therapy for COVID-19 can be
<br> included. This includes Remdesivir, Dexamethasone (or other steroids), and convalescent
<br> plasma.
<br>
<br> 3.1.7 Ability to understand and the willingness to sign a written informed consent
<br> document.
<br>
<br> Exclusion Criteria:
<br>
<br> 3.2.1 Allergy and/or hypersensitivity to CSA.
<br>
<br> 3.2.2 GFR<30 mL/min.
<br>
<br> 3.2.3 ALT (Alanine transaminase) or AST (Aspartate transaminase) >3X upper limits of
<br> normal.
<br>
<br> 3.2.4 Resistant hypertension (BP>140/90 mm Hg despite adherence to maximal doses of three
<br> antihypertensive agents).
<br>
<br> 3.2.5 Active bacterial or mycobacterial infection.
<br>
<br> 3.2.6 Pregnant and/or nursing patients. 3.2.7 Participation in a COVID-19 therapeutic drug
<br> trial.
<br>
<br> 3.2.8 Patients who have received or who are receiving anti-viral medications including
<br> hydroxychloroquine will not be excluded.
<br>
<br> 3.2.9 Patients with psychiatric illness/social situations that would limit compliance with
<br> study requirements.
<br>
<br> 3.2.10 Total cholesterol is < 100 (increased risk of seizure)
<br>
<br> 3.2.11 Concomitant dosing with Tacrolimus is a relative contraindication (increases overall
<br> immunosuppression and decrease seizure threshold
<br>
<br> 3.2.12 Concomitant malignancy is a relative contraindication (Neoral can increase
<br> susceptibility to development of neoplasia)
<br>
<br> 3.2.13 Inability to swallow oral medication
<br>
<br> 3.2.14 Treatment with immunomodulators or immunosuppressant drugs, including but not
<br> limited to IL-6 inhibitors, TNF inhibitors, anti-IL-1 agents, and JAK inhibitors.
<br>
<br> 3.2.15 Investigational Antiviral agents
<br> | | SARS (Disease) | Drug: Cyclosporine;Other: Standard of Care Treatment | WHO COVID-19 clinical severity scale | | | | Yes | False | | |
| → | NCT04495816 | 8 March 2021→8 November 2021 | COVID-19 Anosmia Study | COVID-19 Anosmia Study | | Icahn School of Medicine at Mount Sinai | 30/07/2020 | 20200730 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04495816 | Recruiting→Not recruiting | No | 18 Years | N/A | All | July 15, 2020 | 126 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | United States | ; ; → | Alfred-Marc Iloreta, MD;Alfred-Marc Iloreta, MD;Alfred-Marc Iloreta, MD→Alfred-Marc Iloreta, MD | | ;alfred-marc.iloreta@mountsinai.org;alfred-marc.iloreta@mountsinai.org→ | ;212-241-5944;212-241-5944→ | Icahn School of Medicine at Mount Sinai;→Icahn School of Medicine at Mount Sinai |
<br> Inclusion Criteria:
<br>
<br> - Adults (18 years of age or older) with self-reported new-onset olfactory dysfunction
<br>
<br> - Positive COVID-19 diagnosis will be deemed eligible for inclusion.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients <18 years of age
<br>
<br> - Patients who are unable to provide informed consent
<br>
<br> - Patients without a positive COVID-19 PCR result obtained through nasopharyngeal swab -
<br> Patients with a COVID-19 diagnosis but without self-reported anosmia
<br>
<br> - Patients with severe COVID-19 disease as defined by the Mouth Sinai Health System
<br> Treatment Guidelines for SARS-COV-2 (requiring high flow nasal cannula,
<br> non-rebreather, CPAP/BIPAP, or mechanical ventilation OR patients requiring pressor
<br> medication OR patients with evidence of end organ damage)
<br>
<br> - Patients with pre-existing self-reported olfactory dysfunction
<br>
<br> - Patients with a history of chronic nasal/sinus infections (rhinosinusitis) or history
<br> of endoscopic sinus surgery
<br>
<br> - Patients using nasal steroid sprays or irrigations for any reason
<br>
<br> - Patients who are prisoners of the state
<br>
<br> - Patients who have psychiatric or developmental disorder conditions that may impair
<br> ability to provide informed consent
<br>
<br> - Patients will also be excluded if they have an allergy to fish or an omega-3
<br> supplement, or do not eat fish or fish- containing substances for any reason
<br> | | Anosmia;Covid19 | Drug: Omega-3 Fatty Acid Supplement;Drug: Placebo/Control | Brief Smell Identification Test (BSIT);Brief Smell Identification Test (BSIT) | | | | Yes | False | | |
| → | NCT04497948 | 11 January 2021→8 November 2021 | Acalabrutinib Study With Best Supportive Care in Participants Hospitalized With COVID-19 | An Open-label, Multiple-dose Study of Acalabrutinib, Co Administered With a Proton-pump Inhibitor, in Participants Hospitalized With COVID-19 | | Acerta Pharma BV | 16/06/2020 | 20200616 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04497948 | Not recruiting | No | 18 Years | 100 Years | All | September 21, 2020 | 8→9 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | United States;Brazil;United States→Brazil;United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Participant or legally authorized representative must be able to understand the
<br> purpose and risks of the study and provide written informed consent and authorization
<br> to use protected health information (in accordance with national and local patient
<br> privacy regulations).
<br>
<br> 2. Participants who are hospitalized with coronavirus (SARS-CoV-2) infection, confirmed
<br> by PCR test or other commercial or public health assay in any specimen, as documented
<br> by either of the following:
<br>
<br> 1. PCR positive in sample collected < 72 hours prior to first dose, OR
<br>
<br> 2. PCR positive in sample collected = 72 hours prior to first dose (but no more than
<br> 14 days prior to first dose), documented inability to obtain a repeat sample (eg,
<br> due to lack of testing supplies, limited testing capacity, results taking > 24
<br> hours, etc), AND progressive disease suggestive of ongoing SARS-CoV-2 infection 3
<br> Evidence of respiratory failure attributable to COVID-19 pneumonia (documented
<br> radiographically) before enrollment 4 Nasogastric tube or other types of oral or
<br> percutaneous gastric feeding tube; placement must be radiographically confirmed
<br> and expected to remain in place, as judged by the investigator, for a minimum of
<br> 3 days after study enrolment.
<br>
<br> 5 Has received treatment with PPIs (eg, omeprazole, esomeprazole, lansoprazole,
<br> dexlansoprazole, rabeprazole, or pantoprazole) for a minimum of 24 hours
<br> immediately prior to enrollment; any PPI will be permitted, provided it meets the
<br> minimum equivalent daily dose of 20 mg rabeprazole.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Any serious and uncorrectable medical condition or abnormality of clinical
<br> laboratory tests that, in the Investigator's judgment, precludes the
<br> participant's safe participation in and completion of the study.
<br>
<br> 2. In the opinion of the Investigator, progression to death is imminent and
<br> inevitable within the next 24 hours, irrespective of the provision of
<br> treatments.
<br>
<br> 3. Current refractory nausea and vomiting, malabsorption syndrome, disease
<br> significantly affecting gastrointestinal function, resection of the stomach,
<br> extensive small bowel resection that is likely to affect absorption,
<br> symptomatic inflammatory bowel disease, partial or complete bowel
<br> obstruction, or gastric restrictions and bariatric surgery, such as gastric
<br> bypass.
<br>
<br> 4. Received BTK inhibitor within 7 days before enrollment.
<br>
<br> 5. Requires or is receiving anticoagulation with warfarin or equivalent vitamin
<br> K antagonists (eg, phenprocoumon) within 7 days prior to enrollment. Other
<br> anticoagulants are permitted.
<br>
<br> 6. Participants on dual antiplatelet and therapeutic anticoagulant therapy (eg,
<br> aspirin and therapeutic doses of low molecular weight heparin are not
<br> allowed; however, aspirin and prophylactic/ low doses of
<br> low-molecular-weight heprin are allowed).
<br> | | COVID-19 | Drug: Acalabrutinib | Type, frequency, severity, and relationship to study intervention of any treatment-emergent AEs or abnormalities of laboratory tests, SAEs, or AEs leading to discontinuation of study intervention;Acalabrutinib and ACP-5862 plasma PK parameter: Cmax;Acalabrutinib and ACP-5862 plasma PK parameter: AUClast;Acalabrutinib and ACP-5862 plasma PK parameter: AUC12h→Maximum Observed Plasma Concentration (Cmax) for Acalabrutinib and ACP-5862 in Visit 1 (Day 1), Visit 2(Day2) and Visit 3 (Day 5);Area Under the Concentration-time Curve From 0 to Time to Last Quantifiable Concentration (AUClast) for Acalabrutinib and ACP-5862 in Visit 1 (Day 1), Visit 2 (Day 2), and Visit 3 (Day 5);Area Under the Concentration-time Curve From 0 to 12 Hours (AUC12h) for Acalabrutinib and ACP-5862 in Visit 1 (Day 1), Visit 2 (Day 2), and Visit 3 (Day 5) | →05/11/2021 | | →https://clinicaltrials.gov/ct2/show/results/NCT04497948 | Yes | False | | →Yes |
| → | NCT04500626 | 27 September 2021→8 November 2021 | Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients | Multicentre Randomized Controlled Trial of Hyperbaric Versus Normobaric Oxygen Therapy for COVID-19 Patients | | Ottawa Hospital Research Institute | 31/07/2020 | 20200731 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04500626 | Recruiting | No | 18 Years | N/A | All | April 15, 2021 | 234 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | Phase 2/Phase 3 | Canada | ; ; → ; | Sylvain Boet, MD, PhD;Sylvain Boet, MD, PhD;Sylvain Boet, MD, PhD→Sylvain Boet, MD, PhD;Sylvain Boet, MD, PhD | | ;sboet@toh.ca;sboet@toh.on.ca→;sboet@toh.ca | ;613-737-8899;6137985555→;613-737-8899 | The Ottawa Hospital; |
<br> Inclusion Criteria:
<br>
<br> - Male or non-pregnant female patients
<br>
<br> - Age =18 years
<br>
<br> - Confirmed COVID-19 positive by RT-PCR or another validated method
<br>
<br> - Diagnosed with pneumonia requiring 21%<FIO2=100% to maintain saturation by pulse
<br> oximetry (SpO2) =90%
<br>
<br> - Able and willing to comply with study procedures and follow-up examinations contained
<br> within the written consent form
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient clinical status felt to be incompatible with HBOT, e.g. respiratory failure
<br> requiring mechanical ventilation
<br>
<br> - Pregnancy, determined by a serum or urine test
<br>
<br> - Hemodynamic instability requiring vasopressors
<br>
<br> - Inability to maintain a sitting position during treatment
<br>
<br> - Inability to effectively understand and communicate with the hyperbaric operator, or
<br> to give consent
<br>
<br> - Inability to spontaneously equalize ears and refusal of myringotomies
<br>
<br> - Contraindications to HBOT (e.g. pneumothorax)
<br> | | Covid19 | Drug: Oxygen | 7-level COVID Ordinal Outcome Scale | | | | Yes | False | | |
| → | NCT04504734 | 13 September 2021→8 November 2021 | Bucillamine in Treatment of Patients With COVID-19 | Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of Bucillamine in Patients With Mild-Moderate COVID-19 | | Revive Therapeutics, Ltd. | 04/08/2020 | 20200804 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04504734 | Recruiting | No | 18 Years | 80 Years | All | November 27, 2020 | 1000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States;Puerto Rico;United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Is within 72 hours from onset of symptoms consistent with COVID 19 at time of study
<br> enrollment
<br>
<br> - Has at least 2 of the following: fever (oral temperature =38°C), cough, shortness of
<br> breath, chest x ray changes consistent with COVID-19 at time of screening
<br>
<br> - Has peripheral capillary oxygen saturation (SpO2) =94 by pulse oximetry at time of
<br> screening
<br>
<br> - Has either a laboratory-confirmed SARS-CoV-2 infection as determined by FDA-approved
<br> rapid diagnostic (e.g., PCR) assay
<br>
<br> - Has a score of = 2 on the 8-category NIAID ordinal scale at time of screening
<br>
<br> - Agrees to the collection of blood and urine samples, nasopharyngeal (NP) swabs, and
<br> non-invasive oxygen monitoring (via pulse oximeter) per protocol
<br>
<br> - Patient (or their legally authorized representative) is willing and able to provide
<br> written informed consent prior to performing study procedures
<br>
<br> - Understands and agrees to comply with planned study procedures
<br>
<br> - Women of childbearing potential must agree to either abstinence or use at least 1
<br> primary form of contraception not including hormonal contraception from the time of
<br> screening through Day 29 following randomization. All subjects of childbearing
<br> potential, including males with partners of childbearing potential, must use highly
<br> effective methods of birth control defined as those, alone or in combination, that
<br> result in a low failure rate (i.e., less than 1 percent per year) when used
<br> consistently and correctly. Abstinence is NOT an acceptable method of contraception
<br> UNLESS it is the subject's normal practice.
<br>
<br> Exclusion Criteria:
<br>
<br> - Prior history of, or considered to be at risk for, agranulocytosis, nephropathy, liver
<br> disease, or interstitial pneumonia
<br>
<br> - Serious hepatic disorder (Child-Pugh scores B or C) or alanine transaminase (ALT) or
<br> aspartate transaminase (AST) > 5 times the upper limit of normal (ULN) at screening
<br>
<br> - Chronic kidney disease (CKD) National Kidney Foundation (NKF) stages 3B - 5 chronic
<br> renal dysfunction (estimated glomerular filtration rate [eGFR] <45 mL/min/1.73m2
<br> according to Cockcroft Gault formula)
<br>
<br> - Proteinuria = 1+ or = 30 mg on dipstick urinalysis that is confirmed on repeat
<br> assessment within 24 hours
<br>
<br> - Serum BUN = 2 × ULN or Cr = 2 × ULN
<br>
<br> - Leukopenia with absolute granulocyte count < 1500/µL
<br>
<br> - History of positive Human Immunodeficiency virus (HIV) test or organ transplant
<br>
<br> - Receipt of cancer chemotherapy or immunomodulatory drugs including (but not limited
<br> to) biologics such as anti-CD20, anti-TNF, anti-IL6; alkylating agents (e.g.,
<br> cyclophosphamide); antimetabolites (e.g., azathioprine); or chronic corticosteroid use
<br> equivalent to prednisone >10 gm/day, during preceding 2 months
<br>
<br> - Confirmed positive for influenza at screening
<br>
<br> - Confirmed positive for respiratory syncytial virus (RSV) at screening
<br>
<br> - Pregnant or breastfeeding
<br>
<br> - Current use of, or known allergy to bucillamine or penicillamine (e.g., for Wilson's
<br> disease, rheumatoid arthritis)
<br>
<br> - Current participation in any other clinical trial of an experimental treatment
<br>
<br> - Receipt of any experimental treatment for COVID-19 (herbal/homeopathic, off-label,
<br> compassionate use, or trial related) within the 30 days prior to screening
<br> | | Covid19 | Drug: Bucillamine;Drug: Placebo;Drug: Bucillamine | Efficacy: Frequency of hospitalization or death | | | | Yes | False | | |
| → | NCT04505722 | 1 November 2021→8 November 2021 | A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants | A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Assess the Efficacy and Safety of Ad26.COV2.S for the Prevention of SARS-CoV-2-mediated COVID-19 in Adults Aged 18 Years and Older | ENSEMBLE | Janssen Vaccines & Prevention B.V. | 31/07/2020 | 20200731 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04505722 | Not recruiting | Yes | 18 Years | N/A | All | September 7, 2020 | 44325 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States;Argentina;Brazil;Chile;Colombia;Mexico;Peru;South Africa;Argentina;Brazil;Chile;Colombia;Mexico;Peru;South Africa;United States;Philippines;Ukraine | | Janssen Vaccines & Prevention B.V. Clinical Trial | | | | Janssen Vaccines & Prevention B.V. |
<br> Inclusion Criteria:
<br>
<br> - Contraceptive (birth control) use should be consistent with local regulations
<br> regarding the acceptable methods of contraception for those participating in clinical
<br> studies
<br>
<br> - All participants of childbearing potential must: have a negative highly sensitive
<br> urine pregnancy test at screening; and have a negative highly sensitive urine
<br> pregnancy test immediately prior to each study vaccine administration
<br>
<br> - Participant agrees to not donate bone marrow, blood, and blood products from the first
<br> study vaccine administration until 3 months after receiving the last dose of study
<br> vaccine
<br>
<br> - Must be willing to provide verifiable identification, has means to be contacted and to
<br> contact the investigator during the study
<br>
<br> - Must be able to read, understand, and complete questionnaires in the electronic
<br> clinical outcome assessment (eCOA) (that is, the coronavirus disease-2019 [COVID 19]
<br> signs and symptoms surveillance question, the e-Diary, and the electronic
<br> patient-reported outcomes (ePROs). Note: Participants with visual impairment are
<br> eligible for study participation and may have caregiver assistance in completing the
<br> electronic clinical outcome assessment (eCOA) questionnaires
<br>
<br> Exclusion Criteria:
<br>
<br> - Participant has a clinically significant acute illness (this does not include minor
<br> illnesses such as diarrhea or mild upper respiratory tract infection) or temperature
<br> greater than or equal to (>=) 38.0 degree Celsius (100.4-degree Fahrenheit) within 24
<br> hours prior to the planned first dose of study vaccine; randomization at a later date
<br> is permitted at the discretion of the investigator and after consultation with the
<br> sponsor
<br>
<br> - Participant received or plans to receive: (a) licensed live attenuated vaccines -
<br> within 28 days before or after planned administration of study vaccine ; and (b) other
<br> licensed (not live) vaccines - within 14 days before or after planned administration
<br> of study vaccine
<br>
<br> - Participant previously received a coronavirus vaccine
<br>
<br> - Participant received an investigational drug (including investigational drugs for
<br> prophylaxis of COVID-19) within 30 days or used an invasive investigational medical
<br> device within 30 days or received investigational immunoglobulin (Ig) or monoclonal
<br> antibodies within 3 months, or received convalescent serum for COVID-19 treatment
<br> within 4 months or received an investigational vaccine (including investigational
<br> Adenoviral-vectored vaccines) within 6 months before the planned administration of the
<br> first dose of study vaccine or is currently enrolled or plans to participate in
<br> another investigational study during the course of this study
<br> | | Participants With or Without Stable Co-morbidities Associated With Progression to Severe COVID-19 at Different Stages of the Protocol | Biological: Ad26.COV2.S;Other: Placebo | Number of Participants with First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status (Open-label Booster Vaccination Phase);Number of Participants with First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status (Open-label Booster Vaccination Phase);Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status (Open-label Booster Vaccination Phase);Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status (Open-label Booster Vaccination Phase);Number of Participants with Adverse Events of Special Interest (AESI) from Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase);Number of Participants with Serious Adverse Events (SAEs) from Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase);Number of Participants with Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase);Number of Participants with Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase);Number of Participants with Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase);Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status (Main Study);Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status (Main Study)→Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status (Main Study);Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status (Main Study);Number of Participants with Solicited Local Adverse Events (AEs) Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase);Number of Participants with Solicited Systemic AEs Up to 7 Days After Booster Vaccination (Open-label Booster Vaccination Phase);Number of Participants with Unsolicited AEs Up to 28 Days After Booster Vaccination (Open-label Booster Vaccination Phase);Number of Participants with Serious Adverse Events (SAEs) from Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase);Number of Participants with Adverse Events of Special Interest (AESI) from Booster Vaccination Until End of the Study (Open-label Booster Vaccination Phase);Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status (Open-label Booster Vaccination Phase);Number of Participants with First Occurrence of Molecularly Confirmed Moderate to Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status (Open-label Booster Vaccination Phase);Number of Participants with First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status (Open-label Booster Vaccination Phase);Number of Participants with First Occurrence of Molecularly Confirmed Severe/Critical Coronavirus Disease (COVID-19) with Seronegative Status (Open-label Booster Vaccination Phase) | | | | Yes | True | parent | |
| → | NCT04505774 | 1 November 2021→8 November 2021 | Accelerating COVID-19 Therapeutic Interventions and Vaccines 4 ACUTE | A Multicenter, Adaptive, Randomized Controlled Platform Trial of the Safety and Efficacy of Antithrombotic and Additional Strategies in Hospitalized Adults With COVID-19 | ACTIV-4A | Matthew Neal MD | 06/08/2020 | 20200806 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04505774 | Recruiting | Yes | 18 Years | N/A | All | September 4, 2020 | 3000 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 4 | United States;Brazil;Italy;Spain;Brazil;Italy;Spain;United States→United States;Brazil;Italy;Spain;Brazil;Italy;United States;Spain | ; ; ; ; | Judith Hochman, MD;Scott Solomon, MD;Mikhail Kosiborod, MD;Jeffrey Berger, MD;Judith Hochman, MD | | ;;;;Judith.Hochman@nyulangone.org | ;;;;212-263-6927 | New York University - Grossman School of Medicine;Brigham and Women's Hospital;Saint Lukes;New York University - Grossman School of Medicine; |
<br> Inclusion Criteria:
<br>
<br> - = 18 years of age
<br>
<br> - Hospitalized for COVID-19
<br>
<br> - Enrolled within 72 hours of hospital admittance or 72 hours of positive COVID test
<br>
<br> - Expected to require hospitalization for > 72 hours
<br>
<br> Exclusion Criteria:
<br>
<br> - Imminent death
<br>
<br> - Requirement for chronic mechanical ventilation via tracheostomy prior to
<br> hospitalization
<br>
<br> - Pregnancy
<br>
<br> Inclusion Criteria for Arm E
<br>
<br> Inclusion criteria contained in the master protocol in addition to the following:
<br>
<br> Moderate illness severity - defined as non-ICU level of care at the time of randomization
<br> (not receiving high flow nasal oxygen (HFNO), non-invasive ventilation (NIV), invasive
<br> ventilation (IV), vasopressors or inotropes, or extracorporeal membrane oxygenation (ECMO)
<br> OR Severe illness severity - defined as ICU level of care at the time of randomization
<br> (receiving HFNO, NIV, IV, vasopressors or inotropes, or ECMO)
<br>
<br> For moderate illness severity, participants are required to meet one or more of the
<br> following risk criteria:
<br>
<br> 1. Age = 65 years or
<br>
<br> 2. =2 of the following -
<br>
<br> - O2 supplementation > 2 liters per minute
<br>
<br> - BMI = 35
<br>
<br> - GFR = 60
<br>
<br> - History of Type 2 diabetes
<br>
<br> - History of heart failure (regardless of ejection fraction)
<br>
<br> - D dimer = 2x the site's upper limit of normal (ULN)
<br>
<br> - Troponin = 2x the site's ULN
<br>
<br> - BNP=100 pg/mL or NT-proBNP=300 pg/mL
<br>
<br> - CRP =50 mg/L
<br>
<br> Exclusion Criteria for Arm E
<br>
<br> - Exclusion criteria contained in the master protocol, and
<br>
<br> - Any condition that, in the opinion of the investigator, precludes the use of
<br> crizanlizumab such as uncontrolled bleeding or severe anemia (hemoglobin<4 g/dL)
<br>
<br> - Open label treatment with crizanlizumab within the past three months
<br>
<br> Inclusion Criteria for Arm F
<br>
<br> Inclusion criteria contained in the master protocol in addition to the following:
<br>
<br> Moderate illness severity - defined as non-ICU level of care at the time of randomization
<br> (not receiving high flow nasal oxygen (HFNO), non-invasive ventilation (NIV), invasive
<br> ventilation (IV), vasopressors or inotropes, or extracorporeal membrane oxygenation (ECMO))
<br> OR Severe illness severity - defined as ICU level of care at the time of randomization
<br> (receiving HFNO, NIV, IV, vasopressors or inotropes, or ECMO)
<br>
<br> For moderate illness severity, participants are required to meet one or more of the
<br> following risk criteria:
<br>
<br> 1. Age = 65 years or
<br>
<br> 2. =2 of the following-
<br>
<br> - O2 supplementation > 2 liters per minute
<br>
<br> - BMI = 35
<br>
<br> - GFR = 60
<br>
<br> - History of Type 2 diabetes
<br>
<br> - History of heart failure (regardless of ejection fraction)
<br>
<br> - D dimer = 2x the site's upper limit of normal (ULN)
<br>
<br> - Troponin = 2x the site's ULN
<br>
<br> - BNP=100 pg/mL or NT-proBNP=300 pg/mL
<br>
<br> - CRP =50 mg/L
<br>
<br> Exclusion Criteria for Arm F
<br>
<br> In addition to the exclusion criteria noted in the master protocol, arm-specific exclusion
<br> criteria are as follows:
<br>
<br> - Known hypersensitivity to any SGLT2 inhibitors
<br>
<br> - Type 1 diabetes
<br>
<br> - History of diabetic ketoacidosis
<br>
<br> - eGFR <20 and/or requirement for renal replacement therapy
<br>
<br> - Open label treatment with any SGLT2 inhibitor
<br>
<br> - Based on a recommendation from the ACTIV4 DSMB on December 19, 2020, enrollment
<br> of patients requiring ICU level of care into the therapeutic anti-coagulation arm
<br> was stopped due to meeting a futility threshold and a potential for harm for this
<br> sub-group could not be excluded. Enrollment continues for moderately ill
<br> hospitalized COVID-19 patients.
<br>
<br> - Based on a recommendation from the ACTIV4 DSMB on June 18, 2021, enrollment of
<br> patients not requiring ICU level of care and randomized to P2Y12 or standard care
<br> was stopped due to meeting a futility threshold. Enrollment continues for
<br> severely ill (ICU level of care) hospitalized COVID-19 patients.
<br> | | Covid19 | Drug: theraputic heparin;Drug: prophylactic heparin;Drug: P2Y12;Drug: Crizanlizumab Injection;Drug: SGLT2 inhibitor | 21 Day Organ Support (respiratory or vasopressor) Free Days | | | | Yes | True | parent | |
| → | NCT04507256 | 1 November 2021→8 November 2021 | AZD7442 - a Potential Combination Therapy for the Prevention and Treatment of COVID-19 | A Phase I Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability and Pharmacokinetics of AZD7442 in Healthy Adults | | AstraZeneca | 07/08/2020 | 20200807 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04507256 | Not recruiting | No | 18 Years | 55 Years | All | August 18, 2020 | 60 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 1 | United Kingdom | | Pablo Forte Soto, MD, MSc, PhD | | | | Parexel EPCU (London) |
<br> Inclusion Criteria:
<br>
<br> - Written informed consent and any locally required authorisation obtained from the
<br> participant prior to performing any protocol-related procedures, including screening
<br> evaluations.
<br>
<br> - Negative SARS-CoV-2 qRT-PCR and/or serology tests prior to randomisation.
<br>
<br> - Weight = 50 kg and = 110 kg at screening, including a BMI of = 18.0 to = 30.0 kg/m^2.
<br>
<br> - Healthy by medical history, physical examination, and baseline safety laboratory
<br> studies, according to the judgement of the PI.
<br>
<br> - Electrocardiogram without clinically significant abnormalities at screening.
<br>
<br> - Able to complete the Follow-up Period through Day 361.
<br>
<br> - Females of childbearing potential who are sexually active with a non-sterilised male
<br> partner must have used a highly effective method of contraception for at least 28 days
<br> prior to dosing with IMP and must agree to continue using such precautions until the
<br> Final Follow-up Visit. Periodic abstinence, the rhythm method, and the withdrawal
<br> method are not acceptable methods of contraception.
<br>
<br> Exclusion Criteria:
<br>
<br> - Known hypersensitivity to any component of the IMP.
<br>
<br> - History of allergic disease or reactions likely to be exacerbated by any component of
<br> the IMP.
<br>
<br> - Previous hypersensitivity, infusion-related reaction or severe adverse reaction
<br> following administration of a mAbs.
<br>
<br> - Acute (time-limited) illness, including fever above 37.5°C (99.5 °F), on day prior to
<br> or day of planned dosing; participants excluded for transient acute illness may be
<br> dosed if illness resolves within the 27-day Screening Period or may be rescreened
<br> once.
<br>
<br> - Any drug therapy within 7 days prior to Day 1 (except contraceptives or a single use
<br> of acetaminophen, aspirin, antihistamine, or combination over the counter (OTC)
<br> product that contains acetaminophen with an antihistamine, or OTC nonsteroidal
<br> anti-inflammatory agent at a dose equal to or lower than that recommended on the
<br> package). Vitamins and other nutritional supplements that are not newly introduced,
<br> ie, have been taken for at least 30 days prior to enrolment, are not exclusionary.
<br>
<br> - Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 2 months
<br> prior to screening.
<br>
<br> - Receipt of immunoglobulin or blood products within 6 months prior to screening.
<br>
<br> - SARS CoV-2 or COVID-19:
<br>
<br> - Participants with any confirmed current or previous COVID-19 infection before
<br> randomisation.
<br>
<br> - Participant has clinical signs and symptoms consistent with COVID-19, eg, fever,
<br> dry cough, dyspnoea, sore throat, fatigue or confirmed infection by appropriate
<br> laboratory test within the last 4 weeks prior to screening or on admission.
<br>
<br> - Any prior receipt of investigational or licensed vaccine indicated for the
<br> prevention of SARS CoV-2 or COVID-19 or expected receipt during the period of
<br> study follow up.
<br>
<br> - Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the
<br> period of study follow-up, or concurrent participation in another interventional
<br> study.
<br>
<br> - Previous receipt of a mAb within 6 months, or five antibody half lives (whichever is
<br> longer), prior to study start.
<br>
<br> - Immunodeficiency due to illness, including Human immunodeficiency virus (HIV)
<br> infection, or due to drugs, including any course of glucocorticoid therapy exceeding 2
<br> weeks of prednisone or equivalent at a dose of 20 mg daily or every other day within 6
<br> months prior to screening. HIV testing must be negative at screening.
<br>
<br> - Either history of active infection with hepatitis B or C or positive test for
<br> hepatitis C or for hepatitis B surface antigen at screening.
<br>
<br> - History of infection with SARS or MERS.
<br>
<br> - Aspartate aminotransferase, ALT, or serum creatinine above the ULN; bilirubin and ALP
<br> >1.5 × ULN.
<br>
<br> - Haemoglobin or platelet count below the LLN at screening. White blood cell or
<br> neutrophil count outside normal references ranges.
<br>
<br> - History of malignancy.
<br>
<br> - Any laboratory value in the screening panel that, in the opinion of the PI, is
<br> clinically significant or might confound analysis of study results.
<br>
<br> - Pregnant or nursing female.
<br>
<br> - History of alcohol or drug abuse within the past 2 years that, according to the PI,
<br> might affect assessments of safety or ability of participant to comply with all study
<br> requirements OR positive urine drug or alcohol screening.
<br>
<br> - Any condition that, in the opinion of the PI, might compromise participant safety or
<br> interfere with evaluation of the IMP or interpretation of participant safety or study
<br> results.
<br>
<br> - Employees of the sponsor, clinical study site, or any other individuals involved with
<br> the conduct of the study, or immediate family members of such individuals.
<br>
<br> - Absence of suitable veins for blood sampling (IM and IV cohorts) and administration of
<br> IMP (IV cohorts).
<br> | | COVID-19 | Combination Product: AZD7442;Other: Placebo | Number of participants with adverse events (AEs) and serious AEs | | | | Yes | False | | |
| → | NCT04509947 | 1 November 2021→8 November 2021 | A Study of Ad26.COV2.S in Adults (COVID-19) | A Randomized, Double-blind, Placebo-controlled Phase 1 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Adults | | Janssen Pharmaceutical K.K. | 11/08/2020 | 20200811 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04509947 | Not recruiting | No | 20 Years | N/A | All | August 11, 2020 | 250 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 1 | Japan | | Janssen Pharmaceutical K.K., Japan Clinical Trial | | | | Janssen Pharmaceutical K.K. |
<br> Inclusion Criteria:
<br>
<br> - Participant must have a body mass index (BMI) less than (<) 40.0 kilograms per meter
<br> square (kg/m^2)
<br>
<br> - Contraceptive (birth control) use by women should be consistent with local regulations
<br> regarding the acceptable methods of contraception for those participating in clinical
<br> studies. Before randomization, participants who were born female must be either (a)
<br> not of childbearing potential; (b) of childbearing potential and practicing a highly
<br> effective method of contraception (failure rate of less than (<) 1 percent (%) per
<br> year when used consistently and correctly) and agrees to remain on such a method of
<br> contraception from signing the informed consent until 3 months after the last dose of
<br> study vaccine. Use of hormonal contraception should start at least 28 days before the
<br> first administration of study vaccine. The investigators should evaluate the potential
<br> for contraceptive method failure (example, noncompliance, recently initiated) in
<br> relationship to the first vaccination. Highly effective methods for this study
<br> include: (1) hormonal contraception: (i) combined (estrogen and progestogen
<br> containing) hormonal contraception associated with inhibition of ovulation (oral,
<br> intravaginal, or transdermal); (ii) progestogen-only hormonal contraception associated
<br> with inhibition of ovulation (oral, injectable, or implantable); (2) intrauterine
<br> device (IUD); (3) intrauterine hormone-releasing system (IUS); (4) bilateral tubal
<br> occlusion/litigation procedure; (5) vasectomized partner (the vasectomized partner
<br> should be the sole partner for that participant; (6) sexual abstinence. Applicable to
<br> Cohort 2 only: Before randomization, a woman must be (a) postmenopausal
<br> (postmenopausal state is defined as no menses for 12 months without an alternative
<br> medical cause) or permanently sterile; and (b) not intending to conceive by any
<br> method.
<br>
<br> - All female participants of childbearing potential must: have a negative highly
<br> sensitive urine or serum beta-human chorionic gonadotropin (hCG) pregnancy test at
<br> screening; have a negative highly sensitive urine beta-hCG pregnancy test immediately
<br> prior to each study vaccine administration
<br>
<br> - A male participant must agree not to donate sperm for the purpose of reproduction for
<br> a minimum 28 days after receiving the dose of study vaccine
<br>
<br> - Participant agrees to not donate bone marrow, blood, and blood products from the first
<br> study vaccine administration until 3 months after receiving the last dose of study
<br> vaccine
<br>
<br> Exclusion Criteria
<br>
<br> - Participant has a clinically significant acute illness (this does not include minor
<br> illnesses such as diarrhea or mild upper respiratory tract infection) or temperature
<br> greater than or equal to (>=) 38.0 degree Celsius within 24 hours prior to the planned
<br> first dose of study vaccine; randomization at a later date is permitted at the
<br> discretion of the investigators and after consultation with the sponsor
<br>
<br> - Participant has a history of malignancy within 5 years before screening (exceptions
<br> are squamous and basal cell carcinomas of the skin and carcinoma in situ of the
<br> cervix, or malignancy, which is considered cured with minimal risk of recurrence)
<br>
<br> - Participant has a history of any neurological disorders or seizures including
<br> Guillain-Barre syndrome, with the exception of febrile seizures during childhood
<br>
<br> - Participant previously received a coronavirus vaccine
<br>
<br> - Participant has a positive molecular test result for severe acute respiratory syndrome
<br> coronavirus-2 (SARS-CoV-2) infection, confirmed by polymerase chain reaction (PCR) at
<br> screening
<br>
<br> - Participants who are at increased risk of severe coronavirus disease-2019 (COVID-19),
<br> that is, participants with moderate-to-severe asthma; chronic lung diseases such as
<br> chronic obstructive pulmonary disease (COPD) (including emphysema and chronic
<br> bronchitis), idiopathic pulmonary fibrosis and cystic fibrosis; diabetes (including
<br> type 1, type 2, or gestational); serious heart conditions, including heart failure,
<br> coronary artery disease, congenital heart disease, cardiomyopathies, and pulmonary
<br> hypertension; severe obesity; chronic kidney disease being treated with dialysis;
<br> participants who are immunocompromised (as outlined in other exclusion criteria);
<br> chronic liver disease, including cirrhosis; and participants who live in a nursing
<br> home or long-term care facility
<br>
<br> - Participant currently working in an occupation with a high risk of exposure to
<br> SARS-CoV-2 (example, health care worker or emergency response personnel) or considered
<br> at the investigator's discretion to be at increased risk to acquire COVID-19 for any
<br> other reason
<br> | | Healthy | Biological: Ad26.COV2.S;Biological: Placebo | Number of Participants with Solicited Local Adverse Events (AEs) for 7 days after First Vaccination;Number of Participants with Solicited Local AEs for 7 days after Second Vaccination;Number of Participants with Solicited Systemic AEs for 7 days after First Vaccination;Number of Participants with Solicited Systemic AEs for 7 days after Second Vaccination;Number of Participants with Unsolicited AEs for 28 days after First Vaccination;Number of Participants with Unsolicited AEs for 28 days after Second Vaccination;Number of Participants with Serious Adverse Events (SAEs)→Number of Participants with Solicited Local Adverse Events (AEs) for 7 days after First Vaccination;Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Unsolicited AEs for 28 days after Second Vaccination;Number of Participants with Unsolicited AEs for 28 days after First Vaccination;Number of Participants with Solicited Systemic AEs for 7 days after Second Vaccination;Number of Participants with Solicited Systemic AEs for 7 days after First Vaccination;Number of Participants with Solicited Local AEs for 7 days after Second Vaccination | | | | Yes | False | | |
| → | NCT04535453 | 1 November 2021→8 November 2021 | A Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults and Adolescents | A Randomized, Double-blind, Placebo-controlled Phase 2a Study to Evaluate a Range of Dose Levels and Vaccination Intervals of Ad26.COV2.S in Healthy Adults Aged 18 to 55 Years Inclusive and Adults Aged 65 Years and Older and to Evaluate 2 Dose Levels of Ad26.COV2.S in Healthy Adolescents Aged 12 to 17 Years Inclusive | | Janssen Vaccines & Prevention B.V. | 27/08/2020 | 20200827 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04535453 | Not recruiting | No | 12 Years | N/A | All | August 28, 2020 | 635 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 2 | Germany;Netherlands;Spain;United Kingdom;Germany;Netherlands;Spain;United Kingdom;Brazil;Canada;United States→Brazil;Canada;United States;United Kingdom;Spain;Netherlands;Germany;United Kingdom;Spain;Netherlands;Germany | | Janssen Vaccines & Prevention B.V. Clinical Trial | | | | Janssen Vaccines & Prevention B.V. |
<br> Inclusion Criteria:
<br>
<br> For Adults
<br>
<br> - Participant must have a body mass index (BMI) less than (<) 30.0 kilogram per meter
<br> square (kg/m^2)
<br>
<br> - Participant is 18 to 55 years of age, inclusive, or 65 years of age or older on the
<br> day of signing the informed consent form (ICF).
<br>
<br> - Participant 18 to 55 years of age, inclusive: participant must be healthy, in the
<br> investigator's clinical judgment, as confirmed by medical history, physical
<br> examination, and vital signs performed at screening, and must not have comorbidities
<br> related to an increased risk of severe coronavirus disease-2019 (COVID-19), except for
<br> smoking and mild hypertension, which are allowed. Participant 65 years of age and
<br> older: In the investigator's clinical judgment, participant must be either in good or
<br> stable health. Participant may have underlying illnesses, as long as the symptoms and
<br> signs are medically controlled and not considered to be comorbidities related to an
<br> increased risk of severe COVID-19, except for smoking and mild hypertension, which are
<br> allowed. If on medication for a condition, the medication dose must have been stable
<br> for at least 12 weeks preceding vaccination and expected to remain stable for the
<br> duration of the study. Participant will be included on the basis of physical
<br> examination, medical history, and vital signs
<br>
<br> - Participant will be included on the basis of physical examination, medical history,
<br> and vital signs
<br>
<br> - All participants of childbearing potential must: a) Have a negative highly sensitive
<br> urine pregnancy test at screening, b)Have a negative highly sensitive urine pregnancy
<br> test immediately prior to each study vaccine administration
<br>
<br> - Participant agrees to not donate bone marrow, blood, and blood products from the first
<br> study vaccine administration until 3 months after receiving the last dose of study
<br> vaccine
<br>
<br> - Participant must be willing to provide verifiable identification, has means to be
<br> contacted and to contact the investigator during the study
<br>
<br> For Adolescents:
<br>
<br> - Participant is 12 to 17 years of age, inclusive, on the day of signing the informed
<br> consent form (ICF)
<br>
<br> - Participants must have signed an ICF (or their legally acceptable representative or
<br> parent(s) [preferably both parents if available or as per local requirements] must
<br> sign) indicating that they understand the purpose of, and procedures required for, the
<br> study, are willing/able to adhere to the prohibitions and restrictions specified in
<br> the protocol and study procedures, and are willing (or the parents are willing for
<br> their adolescent) to participate in the study. Informed assent must be obtained from
<br> adolescents, depending on local regulations and practice
<br>
<br> - Participant must be healthy, in the investigator's clinical judgment, as confirmed by
<br> medical history, physical examination, and vital signs performed at screening, and
<br> must not have comorbidities related to an increased risk of severe COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> For Adults
<br>
<br> - Participant has a clinically significant acute illness (this does not include minor
<br> illnesses such as diarrhea or mild upper respiratory tract infection) or temperature
<br> greater than or equal to (>=) 38.0 degree Celsius [C] (100.4 degree Fahrenheit [F])
<br> within 24 hours prior to the planned first dose of study vaccine; randomization at a
<br> later date is permitted at the discretion of the investigator and after consultation
<br> with the sponsor
<br>
<br> - Participant has a history of malignancy within 5 years before screening (exceptions
<br> are squamous and basal cell carcinomas of the skin and carcinoma in situ of the
<br> cervix, or malignancy, which is considered cured with minimal risk of recurrence)
<br>
<br> - Participant has a known or suspected allergy or history of anaphylaxis or other
<br> serious adverse reactions to vaccines or their excipients (including specifically the
<br> excipients of the study vaccine)
<br>
<br> - Participant received treatment with immunoglobulins in the 3 months or blood products
<br> in the 4 months before the planned administration of the first dose of study vaccine
<br> or has any plans to receive such treatment during the study
<br>
<br> - Participant received an investigational drug (including investigational drugs for
<br> prophylaxis of COVID-19) or used an invasive investigational medical device within 30
<br> days or received investigational Ig or monoclonal antibodies within 3 months, or
<br> received convalescent serum for COVID-19 treatment within 4 months or received an
<br> investigational vaccine (including investigational Adenoviral-vectored vaccines)
<br> within 6 months before the planned administration of the first dose of study vaccine
<br> or is currently enrolled or plans to participate in another investigational study
<br> during the course of this study For Adolescents
<br>
<br> - Participant has a known or suspected allergy or history of anaphylaxis or other
<br> serious adverse reactions to vaccines or their excipients (including specifically the
<br> excipients of the study vaccine)
<br>
<br> - Participants with a history of illness or with an ongoing illness that, in the opinion
<br> of the investigator, may pose additional risk to the participant if he/she
<br> participates in the study
<br>
<br> - Participant has a history of Kawasaki disease
<br>
<br> - Participant has a history of an underlying clinically significant acute or chronic
<br> medical condition or physical examination findings for which, in the opinion of the
<br> investigator, participation would not be in the best interest of the participant
<br> (example, compromise the well-being) or that could prevent, limit, or confound the
<br> protocol-specified assessments
<br> | | Healthy | Biological: Ad26.COV2.S;Other: Placebo | Groups 1-6: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 Days After Vaccination 2;Groups 1-6: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After Vaccination 2;Groups 1-6: Virus Neutralization Assay Geometric Mean Titer (GMT) 28 Days After Vaccination 2;Groups 1-6: Enzyme-linked Immunosorbent Assay Geometric Mean Concentrations (GMCs) 28 Days After Vaccination 2;Groups 1-6: Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1;Groups 1-6: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay 28 Days After Vaccination 1;Groups 1-6: Virus Neutralization Assay Geometric Mean Titer 28 Days After Vaccination 1;Groups 1-6: Enzyme-Linked Immunosorbent Assay Geometric Mean Concentrations 28 Days After Vaccination 1;Groups 7-8: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 Days After Vaccination 2;Groups 7-8: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay 28 Days After Vaccination 2;Groups 7-8: Virus Neutralization Assay GMTs 28 Days After Vaccination 2;Groups 7-8: Enzyme-linked Immunosorbent Assay Geometric Mean Concentrations 28 Days After Vaccination 2;Groups 9-10: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 Days After Vaccination 2;Groups 9-10: Serological Response to Vaccination as Measured by ELISA 28 Days After Vaccination 2;Groups 9-10: Virus Neutralization Assay GMTs 28 Days After Vaccination 2;Groups 9-10: Enzyme-linked Immunosorbent Assay GMCs 28 Days After Vaccination 2;Groups 1-6: Number of Participants with Solicited Local AEs for 7 Days After Each Vaccination;Groups 7-8: Number of Participants with Solicited Local AEs for 7 Days After Each Vaccination;Groups 9-10: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination;Groups 1-6: Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination;Groups 7-8: Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination;Groups 9-10: Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination;Groups 1-6: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination;Groups 7-8: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination;Groups 9-10: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination;Groups 1-10: Number of Participants with Serious Adverse Events (SAEs);Groups 1-10: Number of Participants with Adverse Events of Special Interest (AESIs);Groups A-C: Number of Participants with Solicited Local AEs for 7 Days After Vaccination;Groups A-C: Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination;Groups A-C: Number of Participants with Unsolicited AEs for 28 Days After Vaccination;Groups A-C: Number of Participants with SAEs;Groups A-C: Number of Participants with AESIs→Groups 9-10: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination;Groups 1-10: Number of Participants with Serious Adverse Events (SAEs);Groups 1-10: Number of Participants with Adverse Events of Special Interest (AESIs);Groups A-C: Number of Participants with Solicited Local AEs for 7 Days After Vaccination;Groups A-C: Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination;Groups A-C: Number of Participants with Unsolicited AEs for 28 Days After Vaccination;Groups A-C: Number of Participants with SAEs;Groups A-C: Number of Participants with AESIs;Groups 7-8: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination;Groups 1-6: Number of Participants with Unsolicited AEs for 28 Days After Each Vaccination;Groups 9-10: Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination;Groups 7-8: Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination;Groups 1-6: Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination;Groups 9-10: Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Each Vaccination;Groups 7-8: Number of Participants with Solicited Local AEs for 7 Days After Each Vaccination;Groups 1-6: Number of Participants with Solicited Local AEs for 7 Days After Each Vaccination;Groups 9-10: Enzyme-linked Immunosorbent Assay GMCs 28 Days After Vaccination 2;Groups 9-10: Virus Neutralization Assay GMTs 28 Days After Vaccination 2;Groups 9-10: Serological Response to Vaccination as Measured by ELISA 28 Days After Vaccination 2;Groups 9-10: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 Days After Vaccination 2;Groups 7-8: Enzyme-linked Immunosorbent Assay Geometric Mean Concentrations 28 Days After Vaccination 2;Groups 7-8: Virus Neutralization Assay GMTs 28 Days After Vaccination 2;Groups 7-8: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay 28 Days After Vaccination 2;Groups 7-8: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 Days After Vaccination 2;Groups 1-6: Enzyme-Linked Immunosorbent Assay Geometric Mean Concentrations 28 Days After Vaccination 1;Groups 1-6: Virus Neutralization Assay Geometric Mean Titer 28 Days After Vaccination 1;Groups 1-6: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay 28 Days After Vaccination 1;Groups 1-6: Serological Response to Vaccination as Measured by VNA Titers 28 Days After Vaccination 1;Groups 1-6: Enzyme-linked Immunosorbent Assay Geometric Mean Concentrations (GMCs) 28 Days After Vaccination 2;Groups 1-6: Virus Neutralization Assay Geometric Mean Titer (GMT) 28 Days After Vaccination 2;Groups 1-6: Serological Response to Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) 28 Days After Vaccination 2;Groups 1-6: Serological Response to Vaccination as Measured by Virus Neutralization Assay (VNA) Titers 28 Days After Vaccination 2 | | | | Yes | False | | |
| → | NCT04542850 | 1 November 2021→8 November 2021 | Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of 5-ALA-Phosphate + SFC in Subjects With COVID-19 | An Open-Label, Pilot Study to Evaluate the Safety, Tolerability, and Efficacy of 5-Aminolevulinic Acid Phosphate and Sodium Ferrous Citrate (5-ALA-Phosphate + SFC) in Subjects With SARS-CoV-2 Infection (COVID-19) | | Royal College of Surgeons in Ireland - Medical University of Bahrain | 16/08/2020 | 20200816 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04542850 | Recruiting | No | 21 Years | 70 Years | All | November 15, 2020 | 40 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Bahrain | ; | Abdullah Darwish, Dr;Abdulla Darwish, Dr | | ;abdulla.darwish@bdfmedical.org | ;39666023 | Bahrain Defense Force Royal Medical Services, Military Hospital; |
<br> Inclusion Criteria:
<br>
<br> 1. Willing and able to provide written informed consent, or with a legal representative
<br> who can provide informed consent
<br>
<br> 2. Aged = 21 to 70 years
<br>
<br> 3. Acute Respiratory Syndrome Coronavirus (SARS-CoV)-2 infection confirmed by polymerase
<br> chain reaction (PCR) test before beginning study dose regime
<br>
<br> 4. qSOFA = 1
<br>
<br> 5. Currently hospitalized
<br>
<br> 6. Moderate COVID-19 patients should meet any of the following criteria:
<br>
<br> evidence of lower respiratory disease by clinical assessment (qSOFA = 1or imaging) and
<br> saturation of oxygen (SpO2) =94% on room air at sea level.
<br>
<br> Severe COVID-19 patients should meet any of the following criteria: a respiratory
<br> frequency >30 breaths per minute, SpO2 <94% on room air at sea level, ratio of
<br> arterial partial pressure of oxygen to fraction of inspired oxygen (PaO2/FiO2) <300
<br> mmHg, and lung infiltrates >50% (if possible to measure). In exceptional cases the
<br> investigator can decide due to certain signs and symptoms to assign a moderate patient
<br> to the severe group although not all criteria mentioned before are fulfilled (to be
<br> documented with explanation).
<br>
<br> 7. Radiographic evidence (chest X-ray or chest CT scan) of pulmonary infiltrates
<br>
<br> 8. Able to swallow 5 capsules of study product at dosing time points.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subject has critical symptoms of COVID19 infection as defined as: high-flow oxygen
<br> therapy (>15 l/min delivered by nasal cannula or mask) or invasive mechanical
<br> ventilation signifying respiratory failure, septic shock, and/or multiple organ
<br> dysfunction ventilation at screening.
<br>
<br> 2. Subject is nourished via a nasogastric tube
<br>
<br> 3. Subject has acute or chronic type(s) of porphyria or a family history of porphyria
<br>
<br> 4. Subject has demonstrated previous intolerance of 5-ALA and/or SFC by topical or oral
<br> administration (except for photosensitivity)
<br>
<br> 5. Pregnant or nursing women
<br>
<br> 6. Males and females of reproductive potential who have not agreed to use an
<br>
<br> 7. adequate method of contraception during the study For females, adequate birth control
<br> methods will be defined as: hormonal contraceptives, intrauterine device or double
<br> barrier contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel
<br> or foam For males, adequate birth control methods will be defined as double barrier
<br> contraception, i.e., condom + diaphragm, condom or diaphragm + spermicidal gel or foam
<br> For females, menopause is defined as one year without menses; if in question, a
<br> folliclestimulating hormone of >40 U/ml must be documented. Hysterectomy, bilateral
<br> oophorectomy,or bilateral tubal ligation must be documented, as applicable
<br>
<br> 8. Subjects who are unable or unwilling to comply with requirements of the clinical trial
<br>
<br> 9. Participation in any other clinical trial of an experimental treatment for COVID-19
<br>
<br> 10. Evidence of multiorgan failure
<br>
<br> 11. Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 X upper limit
<br> of normal (ULN)
<br>
<br> 12. Creatinine clearance < 50 mL/min using the Cockcroft-Gault formula for participants =
<br> 18 years of age {Cockcroft 1976}
<br>
<br> 13. Any other reason that makes the subject unsuitable in the Investigator's opinion
<br> | | SARS-CoV 2;COVID-19 | Dietary Supplement: 5-ALA-Phosphate + SFC (5-ALA + SFC) | The incidence of treatment emergent Adverse Events (safety and tolerability) of 5-ALA-Phospate + SFC in patients with acute moderate or severe respiratory illness secondary to infection with SARS-CoV-2 virus (COVID-19). | | | | Yes | False | | |
| → | NCT04565665 | 1 November 2021→8 November 2021 | Cord Blood-Derived Mesenchymal Stem Cells for the Treatment of COVID-19 Related Acute Respiratory Distress Syndrome | Study of Cord Blood Derived Mesenchymal Stem Cells for Treatment Acute Respiratory Distress Syndrome | | M.D. Anderson Cancer Center | 22/09/2020 | 20200922 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04565665 | Recruiting | No | 18 Years | N/A | All | July 29, 2020 | 70 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1/Phase 2 | United States | ; ; | Amanda Olson;Bethany Overman;Bethany J. Overman | | ;BJSpears@mdanderson.org;BJSpears@mdanderson.org | ;713-745-4567;713-745-4567 | M.D. Anderson Cancer Center; |
<br> Inclusion Criteria:
<br>
<br> - Patients with moderate to severe ARDS per Berlin criteria secondary to COVID-19.
<br> Moderate to severe is defined in appendix as the following: moderate partial pressure
<br> of arterial oxygen (PaO2)/FiO2 of 100-200 mm Hg, severe PaO2/FiO2 of less than 100 mm
<br> Hg
<br>
<br> - Negative pregnancy test in a woman with childbearing potential defined as not
<br> post-menopausal for 12 months or no previous surgical sterilization
<br>
<br> - Patient or legally authorized representative consent
<br>
<br> - Because of the nature of COVID-19, patients enrolled on this study with COVID-19
<br> associated ARDS may have been previously enrolled in other Investigational New Drug
<br> (IND) trials for their cancer diagnosis or COVID-19. These enrollments will not
<br> exclude them from enrollment to this study
<br>
<br> Exclusion Criteria:
<br>
<br> - Moribund patients not expected to survive up to 48 hours
<br>
<br> - Patients with severe chronic liver disease (Childs-Pugh score > 10)
<br>
<br> - Pregnant and/or lactating women
<br>
<br> - Patients on extracorporeal membrane oxygenation
<br> | | COVID-19 Infection;COVID-19-Associated Acute Respiratory Distress Syndrome;Hematopoietic and Lymphoid Cell Neoplasm;Malignant Solid Neoplasm;Symptomatic COVID-19 Infection Laboratory-Confirmed | Other: Best Practice;Biological: Mesenchymal Stem Cell | Incidence of composite serious adverse events (Phase I);Patients alive without grade 3, 4 infusional toxicity (Phase II);Patients alive with grade 3 or 4 infusional toxicity (Phase II);Patients not alive (Phase II)→Patients not alive (Phase II);Patients alive with grade 3 or 4 infusional toxicity (Phase II);Patients alive without grade 3, 4 infusional toxicity (Phase II);Incidence of composite serious adverse events (Phase I) | | | | Yes | False | | |
| → | NCT04573322 | 1 November 2021→8 November 2021 | Safety and Efficacy of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 (COVID-19) Infected Subjects | Open-label, Pharmacokinetic, Pharmacodynamic, Ascending Dose Safety lead-in Followed by a Single-center, Placebo-controlled, Double-blind, Adaptive, Safety and Efficacy, Pilot Study of Trans Sodium Crocetinate (TSC) in SARS-CoV-2 Infected Subjects | | Diffusion Pharmaceuticals Inc | 29/09/2020 | 20200929 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04573322 | Not recruiting | No | 18 Years | N/A | All | September 10, 2020 | 25 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | Romania | | Adrian Streinu Cercel, MD | | | | National Institute of Infectious Diseases, Bucharest, Romania |
<br> Inclusion Criteria:
<br>
<br> 1. Hospitalized subjects with confirmed SARS-CoV-2 infection and hypoxemia, defined as
<br> SpO2 < 94% on room air or requiring supplemental oxygen
<br>
<br> 2. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or
<br> public health assay in any specimen < 72 hours prior to enrollment.
<br>
<br> 3. WHO ordinal scale score of 3, 4 or 5 at baseline
<br>
<br> 4. Male or non-pregnant female adult =18 years of age at time of enrolment.
<br>
<br> 5. Subject (or legally authorized representative (LAR)) provides written informed consent
<br> prior to initiation of any study procedures.
<br>
<br> 6. Understands and agrees to comply with planned study procedures.
<br>
<br> 7. Illness of any duration
<br>
<br> 8. Women of childbearing potential must have a negative blood pregnancy test at the
<br> screening/baseline visit (Day 1) and agree to use a double method of birth control
<br> through 30 days after the last dose of study drug.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Intubated and mechanically ventilated at baseline
<br>
<br> 2. Receiving extracorporeal membrane oxygenation (ECMO) at baseline
<br>
<br> 3. Severe organ dysfunction (SOFA score > 10)
<br>
<br> 4. Patient or LAR unable to provide written informed consent
<br>
<br> 5. ALT/AST > 3 times the upper limit of normal or serum bilirubin > 1.5 times the upper
<br> limit of normal
<br>
<br> 6. Estimated glomerular filtration rate (eGFR) by Modification of Diet in Renal Disease
<br> (MDRD) formula < 30 mL/min/1.73 m^2 or on dialysis
<br>
<br> 7. Pregnancy or breast feeding.
<br>
<br> 8. Anticipated transfer to another hospital which is not a study site within 72 hours.
<br>
<br> 9. Allergy to any study medication
<br> | | SARS-CoV-2 (Covid19) | Drug: Trans Sodium Crocetinate;Drug: Normal saline | Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability);Time to recovery through Day 28→Time to recovery through Day 28;Incidence of Treatment-Emergent Adverse Events (Safety and Tolerability) | | | | Yes | False | | |
| → | NCT04582266 | 1 November 2021→8 November 2021 | PK and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the US | Pharmacokinetics and Safety of Remdesivir for Treatment of COVID-19 in Pregnant and Non-Pregnant Women in the United States | | National Institute of Allergy and Infectious Diseases (NIAID) | 08/10/2020 | 20201008 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04582266 | Recruiting | No | N/A | N/A | Female | February 12, 2021 | 40 | Observational | | | United States;Puerto Rico;United States | ; ; ; | Mark Mirochnick, MD;Diana Clarke, PharmD;Brookie Best, PharmD, MAS;Elizabeth Greene, MPH | | ;;;egreene@fhi360.org | ;;;9195447040 | Department of Pediatrics, Boston University;Pediatric Infectious Diseases, Boston Medical Center;University of California, San Diego; |
<br> Inclusion Criteria: Arm 1 (Pregnant Women)
<br>
<br> - Of legal age or otherwise able to provide independent informed consent or is unable to
<br> provide informed consent (e.g. impaired capacity) and a Legally Authorized
<br> Representative (LAR) is willing and able to provide written informed consent on behalf
<br> of the participant
<br>
<br> - At study entry, viable intra-uterine pregnancy of any gestational age, based on
<br> medical records.
<br>
<br> - At study entry, hospitalized AND has confirmed or suspected COVID-19, based on medical
<br> records.
<br>
<br> - At study entry, receiving or expected to receive RDV for COVID-19 clinical care, as
<br> prescribed by the clinical care provider and documented in medical records.
<br>
<br> Inclusion Criteria - Arm 2 (Non-Pregnant Women)
<br>
<br> - Of legal age or otherwise able to provide independent informed consent or is unable to
<br> provide informed consent (e.g. impaired capacity) and a Legally Authorized
<br> Representative (LAR) is willing and able to provide written informed consent on behalf
<br> of the participant
<br>
<br> - At study entry, between 18 and 45 years of age, based on medical records and
<br> participant report.
<br>
<br> - Assigned female at birth and at study entry not taking cross-sex hormone therapy.
<br>
<br> - At study entry, not suspected to be pregnant, based on participant report and/or
<br> investigator or designee determination.
<br>
<br> - At study entry, not within 6 weeks postpartum, based on participant report, medical
<br> records, and/or investigator or designee determination.
<br>
<br> - At study entry, hospitalized AND has confirmed or suspected COVID-19, based on medical
<br> records.
<br>
<br> - At study entry, receiving or expected to receive RDV for COVID-19 clinical care, as
<br> prescribed by the clinical care provider and documented in medical records.
<br>
<br> Exclusion Criteria:
<br>
<br> - At study entry, has started or received the 4th RDV infusion.
<br>
<br> - At study entry, evidence of post-menopausal status (medical or surgical), based on
<br> medical records and/or participant report.
<br>
<br> - At study entry, any contraindications to RDV treatment for COVID-19, based on
<br> investigator or designee determination.
<br>
<br> - Received or administered any disallowed medications within 48 hours prior to study
<br> entry.
<br>
<br> - At study entry, has any other condition, that, in the opinion of the site investigator
<br> or designee, would make participation in the study unsafe, complicate interpretation
<br> of study outcome data, or otherwise interfere with achieving study objectives.
<br> | | COVID-19 | Drug: Remdesivir | PK Outcome: Area under the plasma concentration-time curve (AUC) of RDV;PK Outcome: Half-life (t1/2) of RDV;PK Outcome: Trough concentration (Ctrough) of GS-441524;Safety Outcome: Maternal renal adverse event (AE) of any grade;Safety Outcome: Maternal hepatic AE of any grade;Safety Outcome: Maternal hematologic AE of any grade;Safety Outcome: Maternal Grade 3 or higher AE;Safety Outcome: Serious AE;Safety Outcome: Maternal Grade 3 or higher AE assessed as related to RDV by the Clinical Management Committee (CMC);Safety Outcome: Pregnancy loss;Safety Outcome: Congenital anomalies;Safety Outcome: Preterm birth, defined as < 37 weeks;Safety Outcome: Preterm birth, defined as < 34 weeks;Safety Outcome: Small for gestational age, defined as < 10th percentile;Safety Outcome: Newborn birth weight;Safety Outcome: Newborn length;Safety Outcome: Newborn head circumference→Safety Outcome: Newborn head circumference;Safety Outcome: Newborn length;Safety Outcome: Newborn birth weight;Safety Outcome: Small for gestational age, defined as < 10th percentile;Safety Outcome: Preterm birth, defined as < 34 weeks;Safety Outcome: Preterm birth, defined as < 37 weeks;Safety Outcome: Congenital anomalies;Safety Outcome: Pregnancy loss;Safety Outcome: Maternal Grade 3 or higher AE assessed as related to RDV by the Clinical Management Committee (CMC);Safety Outcome: Serious AE;Safety Outcome: Maternal Grade 3 or higher AE;Safety Outcome: Maternal hematologic AE of any grade;Safety Outcome: Maternal hepatic AE of any grade;Safety Outcome: Maternal renal adverse event (AE) of any grade;PK Outcome: Trough concentration (Ctrough) of GS-441524;PK Outcome: Half-life (t1/2) of RDV;PK Outcome: Area under the plasma concentration-time curve (AUC) of RDV | | | | Yes | False | | |
| → | NCT04593940 | 1 November 2021→8 November 2021 | Immune Modulators for Treating COVID-19 | Randomized Master Protocol for Immune Modulators for Treating COVID-19 | ACTIV-1 IM | Daniel Benjamin | 23/09/2020 | 20200923 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04593940 | Recruiting | Yes | 18 Years | N/A | All | October 15, 2020 | 1990 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Investigator, Outcomes Assessor). | Phase 3 | United States;Argentina;Brazil;Mexico;Peru;Argentina;Brazil;Mexico;Peru;United States→United States;Peru;Mexico;Brazil;Argentina;Peru;Mexico;Brazil;Argentina;United States | ; ; | Daniel K Benjamin, MD, PhD;Bill Powderly, MD;Theresa Jasion, MS | | ;;theresa.jasion@duke.edu | ;;919-338-4307 | Duke University;Washington University School of Medicine; |
<br> Inclusion Criteria:
<br>
<br> 1. Admitted to a hospital or awaiting admission in the ED with symptoms suggestive of
<br> COVID-19.
<br>
<br> 2. Subject (or legally authorized representative) provides informed consent prior to
<br> initiation of any study procedures.
<br>
<br> 3. Subject (or legally authorized representative) understands and agrees to comply with
<br> planned study procedures.
<br>
<br> 4. Male or non-pregnant female adults =18 years of age at time of enrollment.
<br>
<br> 5. Has laboratory-confirmed (within 14 days prior to enrollment) SARS-CoV-2 infection as
<br> determined by PCR or other commercial or public health assay in any specimen.
<br>
<br> 6. Ongoing illness of any duration, and at least one of the following:
<br>
<br> - Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
<br>
<br> - Blood oxygen saturation (SpO2) =94% on room air, OR
<br>
<br> - Requiring supplemental oxygen, OR
<br>
<br> - Requiring mechanical ventilation or ECMO.
<br>
<br> 7. Women of childbearing potential must agree to either abstinence or use of at least one
<br> primary form of contraception not including hormonal contraception from the time of
<br> screening through Day 60.
<br>
<br> 8. Agrees to not to participate in another interventional trial for the treatment of
<br> COVID-19 through Day 60.
<br>
<br> Exception 1: Participant may co-enroll in ACTIV-4 (ACTIV-4A and ACTIV-4C). Exception 2:
<br> Participants in ACTIV-2 who have been hospitalized may be enrolled in ACTIV-1 as long as
<br> ACTIV-2 study therapy has been discontinued. They will remain in ACTIV-2 follow-up.
<br>
<br> Exception 3: If participant is already participating in a COVID-19 vaccine trial but
<br> develops COVID-19 disease that requires hospitalization, participant is eligible for this
<br> study, assuming all other inclusion/exclusion criteria are met.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. ALT or AST >10 times the upper limit of normal.
<br>
<br> 2. Estimated glomerular filtration rate (eGFR) <30 mL/min (including patients receiving
<br> hemodialysis or hemofiltration).
<br>
<br> Exception: Participants with an eGFR <30 mL/min may enroll as long as their renal
<br> insufficiency has been stable without renal replacement therapy for =1 month and they
<br> are not current candidates for renal replacement therapy. These participants will not
<br> receive remdesivir.
<br>
<br> 3. Neutropenia (absolute neutrophil count <1000 cells/µL) (<1.0 x 103/µL or <1.0 GI/L).
<br>
<br> 4. Lymphopenia (absolute lymphocyte count <200 cells/µL) (<0.20 x 103/µL or <0.20 GI/L)
<br>
<br> 5. Pregnancy or breast feeding.
<br>
<br> 6. Anticipated discharge from the hospital or transfer to another hospital which is not a
<br> study site within 72 hours.
<br>
<br> 7. Known allergy to any study medication.
<br>
<br> 8. Received cytotoxic or biologictargeted immune-modulator treatments (such as
<br> anti-interleukin-1 [IL-1], anti-IL-6 [tocilizumab or sarilumab], anti-IL-17, or T-cell
<br> or B-cell targeted therapies ([e.g., rituximab), tyrosine kinase], JAK inhibitors
<br> [including baricitinib,], TNF inhibitors, or interferon) within 4 weeks or 5
<br> half-lives prior to screening., whichever is longer. Steroid dependency, defined as
<br> need for prednisone at a dose >10 mg (or equivalent) for >1 month within 2 weeks of
<br> screening, is exclusionary. Note Exception 1: Dexamethasone (at a dose of 6 mg per day
<br> for up to 10 days) is permitted for the treatment of COVID-19 in patients who are
<br> already mechanically ventilated and in patients who require supplemental oxygen at
<br> screening, but who are not mechanically ventilated in accordance with national
<br> guidelines. Note Exception 2: Infusion of convalescent plasma given for treatment of
<br> COVID-19 while on-study is also allowed.
<br>
<br> Exception 3: Monoclonal antibody therapy given for COVID-19 treatment at any time
<br> prior to enrollment is also allowed.
<br>
<br> 9. BasedKnown or suspected history of untreated tuberculosis (TB). TB diagnosis may be
<br> suspected based on medical history and concomitant therapies that would suggest TB
<br> infection, have suspected clinical diagnosis of current active tuberculosis (TB) or,
<br> if. Participants are also excluded if they have known, latent TB treated for less than
<br> 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history
<br> only, no screening required).
<br>
<br> 10. Based on medical history and concomitant therapies that would suggest infection,Known
<br> or suspected serious, active bacterial, fungal, or viral (infection (excepting
<br> SARS-CoV-2 and including, but not limited to, active HBV, HCV, or HIV/AIDS). with the
<br> latter defined as a CD4 count <200 or an unsuppressed HIV viral load), or other
<br> infection (besides COVID-19) that in the opinion of the investigator could constitute
<br> a risk when taking investigational product.
<br>
<br> Note: Broad-spectrum empiric antibiotic usage does not exclude participation.
<br>
<br> 11. Have received any live vaccine (that is,or live attenuated) within 3 months before
<br> screening, or intend to receive a live vaccine (or live attenuated) during the study.
<br> Note Exception: Use of prior non-live (inactivated) vaccinations is allowed for all
<br> participants, including any vaccine for COVID-19.
<br>
<br> 12. Severe hepatic impairment (defined as liver cirrhosis Child stage C).
<br>
<br> 13. CurrentKnown severe heart failure (New York Heart Association [NYHA] III-IV).) or
<br> new-onset left-systolic or global cardiac dysfunction in the setting of COVID-19.
<br>
<br> Exception: Right-sided heart dysfunction or pulmonary hypertension thought related to
<br> COVID-19 is permitted.
<br>
<br> 14. In the Investigator's judgment, the patient has any advanced organ dysfunction that
<br> would not make participation appropriate.
<br> | | Covid19 | Drug: Infliximab;Drug: Abatacept;Drug: Remdesivir;Drug: cenicriviroc (closed to enrollment as of 3-Sep-2021) | Number of patients that recovered from COVID-19 | | | | Yes | True | parent | |
| → | NCT04596098 | 25 January 2021→8 November 2021 | Immune Responses to COVID-19; Isolation of Neutralizing Antibodies for Therapeutics and Vaccine. | Immune Responses to COVID-19 (SARS-CoV-2 Related Infection); Isolation of Human Neutralizing Monoclonal Antibodies for Therapeutics and Vaccine Design Approaches: a Prospective Monocentric Trial With Collaborative Sample Collection. | AcNT-COVID19 | University Hospital, Grenoble | 30/07/2020 | 20200730 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04596098 | Recruiting→Not recruiting | No | 18 Years | N/A | All | April 30, 2020 | 100→53 | Observational | | | France | ; ; → | Pascal POIGNARD, PHD;Pascal POIGNARD, PHD;Pierre AUDOIN, engineer→Pascal POIGNARD, PHD | | ;ppoignard@chu-grenoble.fr;paudoin@chu-grenoble.fr→ | ;+33 4 76 76 56 04;+33668082241→ | University Hospital, Grenoble;→University Hospital, Grenoble |
<br> Inclusion Criteria:
<br>
<br> - Man or woman over 18 years old hospitalized in Grenoble University hospital for a
<br> COVID-19 infection for less than 48 hours,
<br>
<br> - Symptomatic patient with an estimated hospitalization period over 7 days and requiring
<br> regular blood sampling,
<br>
<br> - Patient weighing more than 60 kg.
<br>
<br> - Patient who has given his non-opposition/consent for AcNT study.
<br>
<br> - Patient affiliated toFrench Social Security System.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient non able to consent (such as intubated patient in ICU)
<br>
<br> - Patient protected by the French law (defined as: minor, pregnant or breastfeeding
<br> woman, patient under curatorship, patient deprived of liberty or hospitalized against
<br> his/her will)
<br>
<br> - Patient already included in a clinical trial involving substantial blood sampling
<br> (over 20mL a day or over 150mL a month).
<br>
<br> - Patient whose medical condition is not compatible with the trial (impossibility to
<br> consent, intensive case unit, anaemia with haemoglobin under 10g/dl… )
<br> | | SARS-CoV 2 | Other: Blood sampling | Isolation of recombinant monoclonal neutralizing antibodies directed against SARS-CoV-2, isolated from COVID19 hospitalized patients blood probes.;Isolation of recombinant monoclonal neutralizing antibodies directed against SARS-CoV-2, isolated from COVID19 hospitalized patients blood probes. | | | | Yes | False | | |
| → | NCT04610515 | 1 November 2021→8 November 2021 | Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE) | Innovative Support for Patients With SARS-COV2 Infections (COVID-19) Registry (INSPIRE) | INSPIRE | Rush University Medical Center | 28/10/2020 | 20201028 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04610515 | Recruiting | No | 18 Years | N/A | All | December 15, 2020 | 4800 | Observational [Patient Registry] | | | United States | ; ; | Bala Hota, MD;Robert A Weinstein, MD;Katherine Koo | | ;;inspire@rush.edu | ;;312-952-6615 | Rush University Medical Center;Rush University Medical Center; |
<br> INCLUSION CRITERIA
<br>
<br> 1. Fluent in English or Spanish;
<br>
<br> 2. Age 18 and over;
<br>
<br> 3. Self-reported symptoms suggestive of acute SARSCOV2 infection;
<br>
<br> 4. Under investigation for SARSCOV2 (defined as a patient who has received any screening
<br> or diagnostic test used to detect the presence of COVID19 including any FDA approved
<br> or authorized molecular or antigen-based assay) within the last 42 days.
<br>
<br> EXCLUSION CRITERIA
<br>
<br> 1. Unable to provide informed consent;
<br>
<br> 2. Study team unable to confirm result of diagnostic test for SARSCOV2;
<br>
<br> 3. Does not have access to a hand-held device or computer that would allow for digital
<br> participation in the study;
<br>
<br> 4. Individuals who are prisoners while participating in the study.
<br> | | Covid19;ME/CFS;SARS COV2;Novel Coronavirus Infection;Neurocognitive Disorders;Cardiovascular Diseases | | Assess for medium and long-term sequalae of SARS-CoV-2 infection | | | | Yes | False | | |
| → | NCT04611425 | 26 April 2021→8 November 2021 | REmimazolam Infusion in the Context of Hypnotic Shortage in the Critical Care Unit During the Pandemic of COVID-19, the REHSCU Study→REmimazolam Infusion in the Context of Hypnotic Shortage in the Critical Care Unit During the Pandemic of COVID-19: REHSCU Study | REmimazolam Infusion in the Context of Hypnotic Shortage in the Critical Care Unit During the Pandemic of COVID-19. The Non-randomized, Non-controlled, Pilot, Open, Mono-centric REHSCU Study | REHSCU | Nantes University Hospital | 07/10/2020 | 20201007 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04611425 | Recruiting→Not recruiting | No | 18 Years | 85 Years | All | November 30, 2020 | 30 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | Phase 2 | France | ; ; → | Raphaël CINOTTI, MD;Raphaël CINOTTI, MD;Raphaël CINOTTI, MD→Raphaël CINOTTI, MD | | ;raphael.cinotti@chu-nantes.fr;raphael.cinotti@chu-nantes.fr→ | ;02. 40 08 47 31;02 40 08 47 31→ | CHU de Nantes;→CHU de Nantes |
<br> Inclusion Criteria:
<br>
<br> - Patients at least 18 years old
<br>
<br> - Inclusion in the first 96 hours after ICU admission, after clinical stabilization
<br> according to the attending physician's discretion.
<br>
<br> - Expected duration of general anaesthesia = 24 hours
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients more than 85 years-old
<br>
<br> - Refusal to participate
<br>
<br> - Severe patients with moribund state within the 24 hours after admission to the ICU
<br>
<br> - Withdrawal of Life Sustaining Therapies within the 24 hours after admission to the ICU
<br>
<br> - Any pregnant or breast-feeding patient,
<br>
<br> - Patients with known anaphylactic reactions to benzodiazepines, flumazenil, or a
<br> medical condition such that these agents are contraindicated (according to local
<br> label)
<br>
<br> - Patients with allergy/hypersensitivity to bovine lactose, dextran or any other
<br> excipient in the remimazolam product
<br>
<br> - Presence of acute alcoholic or illicit drug intoxication or benzodiazepine
<br> intoxication
<br>
<br> - Inclusion in another clinical (drug) trial
<br>
<br> - Patient under guardianship or trusteeship
<br>
<br> - Patient under judicial protection
<br>
<br> - Severe hepatic impairment defined as a Child-Pugh score > 10.
<br> | | Acute Respiratory Failure;COVID-19;Trauma;Stroke;Sepsis;Shock | Drug: Remimazolam | composite endpoint including a combination of cardio-vascular and sedation events, from baseline (before infusion) to 8 hours, after the beginning of Remimazolam infusion | | | | Yes | False | | |
| → | NCT04621071 | 1 November 2021→8 November 2021 | Efficacy of Probiotics in Reducing Duration and Symptoms of COVID-19 | Evaluation of the Efficacy of Probiotics to Reduce the Duration and Symptoms of COVID-19 (PROVID-19 Study): a Randomized, Double-blind, Controlled Trial | PROVID-19 | Centre de recherche du Centre hospitalier universitaire de Sherbrooke | 05/11/2020 | 20201105 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04621071 | Not recruiting | No | 18 Years | N/A | All | January 12, 2021 | 17 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | N/A | Canada | | Jean-Charles Pasquier, Dr | | | | CIUSSSE-CHUS |
<br> Inclusion Criteria:
<br>
<br> - First positive test for COVID-19 in the last 5 days;
<br>
<br> - Having symptoms of the COVID-19 at enrollment;
<br>
<br> - Self-caring at home;
<br>
<br> - Living in Quebec for the next 60 days;
<br>
<br> - Able to take medication alone;
<br>
<br> - With access to a phone or to the Internet;
<br>
<br> - Able to give informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Taking probiotic supplements at enrollment;
<br>
<br> - Taking antibiotics for a reason other than COVID-19 at enrollment;
<br>
<br> - Allergies to soy, lactose, yeast, maltodextrin, vitamin C, potato starch, magnesium
<br> stearate, hypromellose or titanium dioxide;
<br>
<br> - Has a chronically weakened immune system (AIDS, lymphoma, chemo-radio- corticosteroid
<br> therapy, immunosuppressive pathology);
<br>
<br> - Was treated with chemo-radio-corticosteroid therapy in the last 6 months;
<br>
<br> - Has active cancer;
<br>
<br> - Taking immunosuppressive drugs (e.g. anti-rejection treatment after organ transplant);
<br>
<br> - Already participating in another clinical trial;
<br>
<br> - Is pregnant, expects to become pregnant in the next few months or is breastfeeding;
<br>
<br> - Has any other condition that would prevent safe participation in the study.
<br> | | COVID-19 | Dietary Supplement: Probiotics (2 strains 10x10^9 UFC);Dietary Supplement: Placebo (potato starch and magnesium stearate) | Duration of symptoms of the COVID-19 | | | | Yes | False | | |
| → | NCT04625738 | 12 December 2020→8 November 2021 | Efficacy of Infusions of MSC From Wharton Jelly in the SARS-Cov-2 (COVID-19) Related Acute Respiratory Distress Syndrome | Efficacy of Infusions of Mesenchymal Stem Cells From Wharton Jelly in the Moderate to Severe SARS-Cov-2 Related Acute Respiratory Distress Syndrome (COVID-19): A Phase IIa Double-blind Randomized Controlled Trial | MSC-COVID19 | Central Hospital, Nancy, France | 04/11/2020 | 20201104 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04625738 | Not recruiting | No | 18 Years | N/A | All | November 6, 2020 | 30 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | →France | ; ; → ; | Bruno LEVY, MD, PhD;Sébastien GIBOT, MD, PhD;Cécile POCHON, MD→Antoine KIMMOUN, MD, PhD;Sébastien GIBOT, MD, PhD | | ;;c.pochon@chru-nancy.fr→; | ;;0033383154629→; | Nancy University Hospital;Nancy University Hospital;→Central Hospital, Nancy, France;Central Hospital, Nancy, France |
<br> Inclusion Criteria:
<br>
<br> 1. Man or woman 18 years of age or older
<br>
<br> 2. Patient with a biologically confirmed SARS-CoV-2 infection (by positive RT-PCR on a
<br> nasopharyngeal sample or any other sample)
<br>
<br> 3. Patient with moderate to severe ARDS according to the BERLIN definition defined by a
<br> PaO2 / FiO2 ratio <200 and with endotracheal intubation and under invasive mechanical
<br> ventilation
<br>
<br> 4. Patient hospitalized in the intensive care unit
<br>
<br> 5. Provision of a written informed consent to participate to the study or for whom the
<br> consent of a family member or support person has been obtained (if the patient is
<br> unable to give consent) or inclusion in an immediate vital emergency if applicable
<br>
<br> 6. Any woman of childbearing age with a negative Beta HCG test
<br>
<br> 7. Social Security affiliation
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patient under invasive mechanical ventilation for more than 48 hours
<br>
<br> 2. Patient with a chronic respiratory disease under oxygen therapy
<br>
<br> 3. Patients with a history of Class III or IV pulmonary arterial hypertension (WHO
<br> classification)
<br>
<br> 4. Patients under ECMO
<br>
<br> 5. Immunosuppressive therapy (including corticosteroid therapy> 20 mg prednisolone)
<br>
<br> 6. Active solid tumor or in remission for less than 2 years, malignant hematological
<br> disease, asplenia
<br>
<br> 7. Patient who has received a hematopoietic stem transplantation or an organ transplant
<br>
<br> 8. Therapeutic limitations like progression to expected death within 24 hours (according
<br> to the opinion of the medical team)
<br>
<br> 9. Hypersensitivity to albumin or to any of the excipients (caprylic acid or sodium
<br> caprylate)
<br>
<br> 10. Patient included in another ongoing interventional therapeutic trial
<br>
<br> 11. Pregnant woman, parturient, nursing mother
<br>
<br> 12. Minor (not emancipated)
<br>
<br> 13. Person without liberty by judiciary or administrative decision
<br>
<br> 14. Person undergoing psychiatric care under Articles L. 3212-1 and L. 3213-1 which do not
<br> fall under the provisions of Article L. 1121-8 (hospitalization without consent).
<br>
<br> 15. Adult over 18 who are under a legal protection measure
<br> | | COVID19 ARDS | Biological: Ex vivo expanded Wharton's Jelly Mesenchymal Stem Cells;Biological: Placebo | PaO2 / FiO2 ratio | | | | Yes | False | | |
| → | NCT04637295 | 8 February 2021→8 November 2021 | Perceptions, Experiences, and Activity in CancEr Survivors During COVID-19 | Perceptions, Experiences, and Activity in CancEr Survivors During COVID-19 | PEACE | University of Nebraska | 17/11/2020 | 20201117 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04637295 | Recruiting→Not recruiting | No | 19 Years | N/A | All | January 27, 2021 | 1000→18 | Observational | | | United States | ; ; → | Diane K Ehlers, PhD;Nicholas J Foggia, MS;Nicholas Foggia→Diane K Ehlers, PhD | | ;nicholas.foggia@unmc.edu;nicholas.foggia@unmc.edu→ | ;4025599468;→ | University of Nebraska;→University of Nebraska |
<br> Inclusion Criteria:
<br>
<br> - Adult with a history of cancer (except non-invasive skin cancer)
<br>
<br> - Diagnosed at age 19 or older
<br>
<br> - Diagnosed within 5 years of study enrollment
<br>
<br> - Access to a computer, tablet, or smartphone with the Internet
<br>
<br> - English reading
<br>
<br> Exclusion Criteria:
<br>
<br> - Unable to read in English
<br> | | Neoplasms Malignant | | Psychosocial Function during COVID-19;Physical Activity | | | | Yes | False | | |
| → | NCT04642638 | 1 November 2021→8 November 2021 | Safety, Immunogenicity, and Efficacy of INO-4800 for COVID-19 in Adults at High Risk of SARS-CoV-2 Exposure | Phase 2/3 Randomized, Blinded, Placebo-Controlled Trial to Evaluate the Safety, Immunogenicity, and Efficacy of INO-4800, a Prophylactic Vaccine Against COVID-19 Disease, Administered Intradermally Followed by Electroporation in Adults at High Risk of SARS-CoV-2 Exposure | | Inovio Pharmaceuticals | 23/11/2020 | 20201123 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04642638 | Not recruiting→Recruiting | No | 18 Years | N/A | All | November 30, 2020 | 7517 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States;Brazil;Colombia;Mexico;Philippines;Brazil;Colombia;Mexico;Philippines;United States→United States;Philippines;Mexico;Colombia;Brazil;Philippines;Mexico;Colombia;Brazil;United States | → ; | Mammen P. Mammen Jr, M.D., FACP, FIDSA→Mammen P. Mammen Jr, M.D., FACP, FIDSA;Inovio Call Center | | →;clinical.trials@inovio.com | →;(267) 440-4237 | Inovio Pharmaceuticals→Inovio Pharmaceuticals; |
<br> Key Inclusion Criteria:
<br>
<br> - Working or residing in an environment with high risk of exposure to SARS-CoV-2 for
<br> whom exposure may be relatively prolonged or for whom personal protective equipment
<br> (PPE) may be inconsistently used, especially in confined settings.
<br>
<br> - Phase 2 only: Screening laboratory results within normal limits for testing laboratory
<br> or are deemed not clinically significant by the Investigator.
<br>
<br> - Be post-menopausal or be surgically sterile or have a partner who is sterile or use
<br> medically effective contraception with a failure rate of < 1% per year when used
<br> consistently and correctly from Screening until 3 months following last dose (Phase 2)
<br> or until last dose (Phase 3).
<br>
<br> Key Exclusion Criteria:
<br>
<br> - Acute febrile illness with temperature higher than or equal to 100.4°F (38.0°C) or
<br> acute onset of upper or lower respiratory tract symptoms (e.g., cough, shortness of
<br> breath, sore throat).
<br>
<br> - Positive serologic or molecular (Reverse transcription polymerase chain reaction
<br> (RT-PCR)) test for SARS-CoV-2 at Screening (this criterion applies to all Phase 2
<br> participants and only applies after approximately 402 participants positive for
<br> SARS-CoV-2 serologic test are randomized in the Phase 3 segment of the study).
<br>
<br> - Pregnant or breastfeeding or intending to become pregnant or intending to father
<br> children within the projected duration of the trial starting from the Screening visit
<br> until 3 months following the last dose (Phase 2) or until last dose (Phase 3).
<br>
<br> - Known history of uncontrolled HIV based on a CD4 count less than 200 cells per cubic
<br> millimeter (/mm^3) or a detectable viral load within the past 3 months.
<br>
<br> - Is currently participating or has participated in a study with an investigational
<br> product within 30 days preceding Day 0.
<br>
<br> - Previous or planned receipt of an investigational (including Emergency Use
<br> Authorization (EUA) or local equivalent authorization) or licensed vaccine for
<br> prevention or treatment of COVID-19, middle east respiratory syndrome (MERS), or
<br> severe acute respiratory syndrome (SARS) (documented receipt of placebo in previous
<br> trial would be permissible for trial eligibility).
<br>
<br> - Respiratory diseases (e.g., asthma, chronic obstructive pulmonary disease) requiring
<br> significant changes in therapy or hospitalization for worsening disease during the 6
<br> weeks prior to enrolment.
<br>
<br> - Immunosuppression as a result of underlying illness or treatment.
<br>
<br> - Lack of acceptable sites available for ID injection and EP.
<br>
<br> - Blood donation or transfusion within 1 month prior to Day 0.
<br>
<br> - Reported alcohol or substance abuse or dependence, or illicit drug use (excluding
<br> marijuana use).
<br>
<br> - Any illness or condition that in the opinion of the investigator may affect the safety
<br> of the participant or the evaluation of any study endpoint.
<br> | | Coronavirus Infection;Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2);COVID-19 Disease | Drug: INO-4800;Device: CELLECTRA® 2000;Drug: Placebo;Device: CELLECTRA® 2000 | Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-?) Enzyme-linked Immunospot (ELISpot) Assay;Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay;Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Virologically-confirmed COVID-19 Disease→Phase 3: Percentage of Participants, (SARS-CoV-2 seronegative at baseline), With Virologically-confirmed COVID-19 Disease;Phase 2: Change From Baseline in Neutralizing Antibody Response Measured by a Pseudovirus-based Neutralization Assay;Phase 2: Change From Baseline in Antigen-specific Cellular Immune Response Measured by Interferon-gamma (IFN-?) Enzyme-linked Immunospot (ELISpot) Assay | | | | Yes | False | | |
| → | NCT04646044 | 1 November 2021→8 November 2021 | A Placebo Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) With Standard of Care in Patients With Mild COVID-19 | A Phase 1b, Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of Bempegaldesleukin (BEMPEG; NKTR-214) Plus Standard of Care Versus Placebo Plus Standard of Care in Adults With Mild COVID-19 | | Nektar Therapeutics | 14/11/2020 | 20201114 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04646044 | Not recruiting | No | 18 Years | N/A | All | November 13, 2020 | 30 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 1 | United States | | Study Director | | | | Nektar Therapeutics |
<br> Inclusion Criteria:
<br>
<br> - Male or female patients, age 18 years or older on the day of signing the informed
<br> consent form.
<br>
<br> - Agrees to admission to an in-patient facility for monitoring from Days 1 to 8,
<br> inclusive.
<br>
<br> - Symptoms of mild illness with COVID-19 without shortness of breath, dyspnea, or
<br> clinical signs indicative of more serious COVID-19.
<br>
<br> - Laboratory confirmed SARS-CoV-2 infection within 4 days prior to the screening visit
<br> or during the 7-day screening period.
<br>
<br> - Respiratory rate < 20 breaths per minute, heart rate < 90 beats per minute (bpm).
<br>
<br> - Oxygen saturation by pulse oximetry > 93% on room air.
<br>
<br> - Body mass index < 35 kg/m2.
<br>
<br> - Estimated glomerular filtration rate (eGFR) = 30 mL/min.
<br>
<br> - Alanine transaminase (ALT) or aspartate transaminase (AST) < 2 x upper limit of normal
<br> (ULN) and total bilirubin < 1.5 x ULN.
<br>
<br> - Agrees to not participate in another clinical trial for the treatment of COVID-19
<br> while on study unless the patient's condition has worsened and is considered to be
<br> moderate, severe, or critical by the Investigator.
<br>
<br> Exclusion Criteria:
<br>
<br> - Shortness of breath, hypoxia, or signs of serious lower airway disease.
<br>
<br> - C-reactive protein, lactate dehydrogenase (LDH), or interleukin-6 (IL-6) > 1.5 x ULN.
<br>
<br> - D-dimer or ferritin > 1.5 x ULN.
<br>
<br> - Imminently requiring, or currently on, mechanical ventilation or extracorporeal
<br> membrane oxygenation (ECMO).
<br>
<br> - Systolic blood pressure < 90 mm Hg or diastolic blood pressure < 60 mm Hg.
<br>
<br> - Evidence of acute respiratory distress syndrome (ARDS) or systemic inflammatory
<br> response syndrome (SIRS)/shock.
<br>
<br> - Known cardiovascular history, including unstable or deteriorating cardiac disease.
<br>
<br> - Autoimmune disease.
<br>
<br> - History of pulmonary embolism (PE), deep vein thrombosis (DVT), or prior clinically
<br> significant venous or non-cerebrovascular accident/transient ischemic attack arterial
<br> thromboembolic event.
<br>
<br> - Central nervous system disease or dysfunction.
<br>
<br> - Requirement for > 2 anti-hypertensive medications.
<br>
<br> - Unwilling to refrain from alcohol consumption from Day 1 of admission to the
<br> in-patient facility until discharge from the facility.
<br>
<br> - Adrenal insufficiency.
<br>
<br> NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
<br> | | Covid-19;Coronavirus Disease 2019 | Drug: Bempegaldesleukin;Drug: Standard of Care;Other: Placebo | AUC of BEMPEG/standard of care (SOC) (PK).;Cmax of BEMPEG /SOC (PK).;Tmax of BEMPEG /SOC (PK).;Incidence of adverse events.;Incidence of treatment emergent adverse events (TEAEs).;Incidence of serious adverse events (SAEs).;Incidence of dose limiting toxicities (DLT) for BEMPEG.;Presence and levels of anti-drug antibodies directed to BEMPEG.;Fold change from baseline in absolute lymphocyte count by Central Laboratory.→Fold change from baseline in absolute lymphocyte count by Central Laboratory.;Presence and levels of anti-drug antibodies directed to BEMPEG.;Incidence of dose limiting toxicities (DLT) for BEMPEG.;Incidence of serious adverse events (SAEs).;Incidence of treatment emergent adverse events (TEAEs).;Incidence of adverse events.;Tmax of BEMPEG /SOC (PK).;Cmax of BEMPEG /SOC (PK).;AUC of BEMPEG/standard of care (SOC) (PK). | | | | Yes | False | | |
| → | NCT04655638 | 1 November 2021→8 November 2021 | HFNT vs. COT in COVID-19 | High-Flow Nasal Therapy Versus Conventional Oxygen Therapy in Patients With COVID-19: A Randomized Controlled Trial (The COVID-HIGH Trial) | COVID-HIGH | Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo | 03/12/2020 | 20201203 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04655638 | Not recruiting | No | 18 Years | N/A | All | February 10, 2021 | 364 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Greece;Italy;Poland;Portugal;Spain;Turkey;Greece;Italy;Poland;Portugal;Spain;Turkey | ; | Andrea Cortegiani, MD;Claudia Crimi, MD | | ; | ; | University of Palermo. Azienda Ospedaliera Policlinico Paolo Giaccone;Respiratory Medicine Unit, "Policlinico-Vittorio Emanuele San Marco" University Hospital |
<br> Inclusion Criteria:
<br>
<br> - Age = 18 years old
<br>
<br> - Tested positive for SARS-CoV-2 using real-time reverse transcriptase PCR (RT-PCR)
<br> nasopharyngeal swabs
<br>
<br> - Clinical signs of acute respiratory infection and radiological evidence of pneumonia
<br>
<br> - Hospital admission in any ward or Emergency Department within 48 h
<br>
<br> - SpO2 = 92% or PaO2/FiO2 < 300 in room air and need for oxygen therapy according to
<br> clinical judgment, at the screening.
<br>
<br> Exclusion Criteria:
<br>
<br> - PaO2/FiO2 = 200
<br>
<br> - Respiratory rate = 28 breaths/min and or severe dyspnea and or use of accessory
<br> muscles
<br>
<br> - Need for immediate intubation or noninvasive ventilation (including CPAP) according to
<br> clinical judgment (e.g. clinical diagnosis of cardiogenic pulmonary edema, respiratory
<br> acidosis pH = 7.3)
<br>
<br> - Patients already on CPAP/NIV or HFNT at study screening
<br>
<br> - Septic shock
<br>
<br> - Evidence of multiorgan failure
<br>
<br> - Glasgow Coma Scale < 13
<br>
<br> - Inability to comprehend the study content and give informed consent
<br>
<br> - PaCO2 > 45 mmHg, (if blood gas available) or history of chronic hypercapnia
<br>
<br> - Patient already on long-term oxygen therapy (LTOT) or home NIV/CPAP (even if only
<br> overnight)
<br>
<br> - Neuromuscular disease
<br>
<br> - Limitation of care based on patients' or physicians' decision
<br> | | Covid19;Acute Respiratory Failure | Device: High Flow Nasal Therapy;Device: Conventional Oxygen Therapy | Proportion of patients needing escalation of treatment during hospital stay | | | | Yes | False | | |
| → | NCT04657809 | 1 November 2021→8 November 2021 | Clinical Assessment of Insulin Fast Dissolving Film in Treatment of Post Infection Anosmia | "Insulin Fast Dissolving Film for Intranasal Delivery Via Olfactory Region, a Promising Approach for the Treatment of Anosmia in COVID 19 Patients: Design, In-vitro Characterization and Clinical Evaluation." | | Soad Ali | 02/12/2020 | 20201202 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04657809 | Not recruiting | No | 18 Years | 70 Years | All | October 1, 2020 | 40 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider). | Phase 2 | Egypt | | Soad Mohamed | | | | Deraya |
<br> Inclusion Criteria:
<br>
<br> - anosmia post covid-19 infection
<br>
<br> Exclusion Criteria:
<br>
<br> - nasal polyps or fractions or syrgery in nose from 6 months or less
<br> | | Anosmia | Combination Product: Insulin film;Device: Fast dissolving film | Smell sensation improvement | | | | Yes | False | | |
| → | NCT04663776 | 1 November 2021→8 November 2021 | Wide Scale Monitoring for Acute Respiratory Infection Using a Mobile-Based Study Platform | Wide Scale Monitoring for Acute Respiratory Infection Using a Mobile-Based Study Platform | | Boston Children's Hospital | 05/12/2020 | 20201205 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04663776 | Not recruiting | No | 18 Years | N/A | All | November 4, 2020 | 100000 | Observational | | | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Adult 18 years or older, Android mobile phone user, Resides in the United States (has
<br> a US home address)
<br>
<br> Exclusion Criteria:
<br>
<br> - Under the age of 18, Does not use an Android mobile device, Opts out of sharing
<br> mobility data, Does not live within the United States
<br> | | Covid19;Influenza;Respiratory Tract Infections;Acute Respiratory Tract Infection;Acute Respiratory Distress Syndrome | | Incidence of in?uenza-like illness (ILI) and COVID-like illness (CLI) in a study participant.;Incidence of COVID-like illness (CLI) in a study participant. | | | | Yes | False | | |
| → | NCT04664101 | 5 July 2021→8 November 2021 | REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19) | REmotely Monitored, Mobile Health-Supported High Intensity Interval Training After COVID-19 Critical Illness (REMM-HIIT-COVID-19) | REMMHIIT-COVID | Duke University | 10/12/2020 | 20201210 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04664101 | Not recruiting | No | 18 Years | N/A | All | October 1, 2021→January 1, 2022 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United States | ; | Paul Wischmeyer, MD;Paul Wischmeyer, MD | | ;paul.wischmeyer@duke.edu | ;919-681-4377 | Duke University; |
<br> Inclusion Criteria:
<br>
<br> 1. Age >= 18 years
<br>
<br> 2. ICU admission and subsequent discharge for primary diagnosis of COVID-19 respiratory
<br> failure or infection requiring intubation and mechanical ventilation for > 48 hours
<br> with an ICU length of stay of = 4 days.
<br>
<br> 3. Ability to ambulate with or without a gait aid prior to hospital discharge
<br>
<br> 4. Expected hospital discharge directly back to patient's residence (not to a skilled
<br> nursing facility, inpatient rehabilitation center, or long-term acute care hospital)
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Not ambulating independently prior to COVID-19 illness (use of a gait aid permitted)
<br>
<br> 2. Functional impairment resulting in inability to exercise at hospital discharge
<br> (including need for home oxygen requirement)
<br>
<br> 3. Unable or unwilling to follow coaching via mobile-health iPhone interaction
<br>
<br> 4. Any absolute contraindications to exercise (as outlined in the American Thoracic
<br> Society Guidelines for Cardiopulmonary Exercise Testing), including but not limited
<br> to:
<br>
<br> 1. Recent (< 5 days) acute primary cardiac event
<br>
<br> 2. Unstable Angina
<br>
<br> 3. Uncontrolled dysrhythmias causing symptoms or hemodynamic compromise
<br>
<br> 4. Symptomatic aortic stenosis
<br>
<br> 5. Uncontrolled symptomatic heart failure
<br>
<br> 6. Acute myocarditis or pericarditis
<br>
<br> 7. Suspected or known dissecting aneurysm
<br> | | Covid19;Critical Illness;High Intensity Interval Training;ICU;Intensive Care Units;Fitness Trackers | Behavioral: REmotely Monitored, Mhealth (REMM) supported High Intensity Interval Training (HIIT);Other: Comparator | Peak oxygen consumption (V02P) at 3 months after hospital discharge | | | | Yes | False | | |
| → | NCT04667780 | 28 June 2021→8 November 2021 | Study to Investigate the Treatment Effect of Colchicine in Patients With COVID-19 | Study to Investigate the Treatment Effect of Colchicine in Patients With COVID-19 | | Ayub Teaching Hospital | 11/12/2020 | 20201211 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04667780 | Not recruiting | No | 18 Years | 65 Years | All | December 10, 2020→December 1, 2020 | 102 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | Pakistan | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. SARS-CoV-2 infection confirmed by PCR.
<br>
<br> 2. Admitted in the hospital in the previous 48 hours, with clinical status 3, 4 or 5 of
<br> WHO classification.
<br>
<br> 3. Age above 18 years old.
<br>
<br> 4. Informed written consent.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Invasive mechanical ventilation needed.
<br>
<br> 2. Established limitation of the therapeutic effort
<br>
<br> 3. Inflammatory bowel disease (IBD: Chron Syndrome or Ulcerative colitis), chronic
<br> diarrhea or malabsorption.
<br>
<br> 4. Previous neuromuscular disease.
<br>
<br> 5. Other disease with an estimated vital prognosis under 1 year.
<br>
<br> 6. Severe renal insufficiency (glomerular filtration rate <30 mL/min/1.73m2)
<br>
<br> 7. Medical records of cirrhosis, active chronic hepatitis or severe hepatic disease
<br> defined by GOT or GPT levels three times above the normal upper limit.
<br>
<br> 8. Patients with previous colchicine treatment for other diseases (mainly chronic
<br> prescriptions for familial Mediterranean fever or gout). Clearance period will not be
<br> required for patients treated with colchicine who stopped the treatment before the
<br> randomization.
<br>
<br> 9. Patients with history of allergic reaction or significant sensitivity to colchicine.
<br>
<br> 10. Treatment with immunosuppressive agents, corticoids or interleukine-1 antagonists for
<br> 6 months before inclusion.
<br>
<br> 11. Pregnant or breastfeeding female, confirmed by a positive result in the human
<br> chorionic gonadotropin (hCG) test.
<br>
<br> 12. Fertile woman, or post-menopausal during less than one year and non-surgically
<br> sterilized. Women of fertile age may be included if using at least one contraceptive
<br> method and preferably two complementary contraceptive methods.
<br>
<br> 13. Use of other investigational drugs in the moment of inclusion, or during 30 days
<br> previous to inclusion.
<br> | | COVID-19 | Drug: Colchicine;Drug: Standard COVID-19 care | Changes in IL-6 concentrations;Changes in the patients' clinical status through the 7 points ordinal scale WHO R&D Blueprint expert group→Changes in the patients' clinical status through the 7 points ordinal scale WHO R&D Blueprint expert group;Changes in IL-6 concentrations | | | | Yes | False | | |
| → | NCT04685681 | 10 May 2021→8 November 2021 | The Get Outside Study | Examining Adults' Activity Choices During COVID-19: The UB GO Study | GO | State University of New York at Buffalo | 07/12/2020 | 20201207 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04685681 | Not recruiting | No | 18 Years | N/A | All | January 7, 2021 | 53 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - 18 years of age or older
<br>
<br> - English speaking
<br>
<br> - Has online access
<br>
<br> - Reports living in Western New York
<br>
<br> - Interested in receiving "suggestions for ways to get outside, stay active, and stay
<br> busy" during COVID-19
<br>
<br> - No health problems that preclude participation
<br>
<br> - Not currently involved in regular (at least weekly) hikes/nature walks
<br>
<br> Exclusion Criteria:
<br>
<br> - Is under 18 years of age
<br>
<br> - Not English speaking
<br>
<br> - Does not have online access
<br>
<br> - Does not report living in Western New York
<br>
<br> - Is not interested in "suggestions for ways to get outside, stay active, and stay busy"
<br> during COVID-19
<br>
<br> - Has health problems precluding participation
<br>
<br> - Is currently involved in regular hikes/nature walks
<br> | | Covid19;Risk Reduction;Stress;Sleep | Behavioral: Hiking challenge;Other: Activity list | Frequency of restaurant dining;Frequency of hiking/nature walks;Frequency of physical activities;Frequency of social activities;Frequency of higher-risk activities;Frequency of lower-risk activities | | | | Yes | False | | |
| → | NCT04690816 | 1 November 2021→8 November 2021 | Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases | The Natural History of Coronavirus Disease (COVID-19) in Systemic Autoimmune Diseases; An Observational Prospective Study | | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | 30/12/2020 | 20201230 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04690816 | Recruiting | No | 15 Years | N/A | All | February 11, 2021 | 350 | Observational | | | United States | ; ; | Mariana J Kaplan, M.D.;Elaine B Poncio;For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) | | ;elaine.poncio@nih.gov;prpl@cc.nih.gov | ;(301) 435-4489;800-411-1222 | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS); |
<br> - INCLUSION CRITERIA:
<br>
<br> In order to be eligible to participate in this study, an individual must meet all of the
<br> following criteria as per respective group:
<br>
<br> 1. Stated willingness to comply with all study procedures and availability for the
<br> duration of the study
<br>
<br> 2. Male or female age greater than or equal to 15 years old with no upper age limit.
<br>
<br> 3. Ability of subject to understand and the willingness to sign a written informed
<br> consent and/or assent document.
<br>
<br> 4. For Healthy Volunteers Group:
<br>
<br> - Age greater than or equal to 15 with no upper age limit.
<br>
<br> - No history of autoimmune diseases and in good general health as evidenced by
<br> medical history.
<br>
<br> 5. For symptomatic COVID-19 group must have laboratory evidence (positive PCR for
<br> SARSCOV-2 or other test developed after this proposal gets approved and is available
<br> through the Clinical Center) and one of the signs and symptoms associated with
<br> COVID-19 infection (e.g. fever or chills, cough, shortness of breath or difficulty
<br> breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore
<br> throat, congestion or runny nose, nausea or vomiting, diarrhea).
<br>
<br> 6. For post COVID-19 study visits must have laboratory evidence (e.g. positive PCR for
<br> SARS- COV-2, antibody against SARS-COV-2 or other test developed after this proposal
<br> gets approved) of current or prior exposure to COVID-19. Alternatively, patients
<br> should have documented evidence of having received one of the SARS-COV-2 vaccines that
<br> may become available during the study.
<br>
<br> 7. For subjects with known COVID exposure, they must fulfill one of the following
<br> criteria:
<br>
<br> - A minimum of 28 days has passed since the initial positive test date AND B.
<br> Resolution of fever was greater than or equal to7 days ago (without the use of
<br> fever-reducing medications) AND C. Resolution of respiratory symptoms was greater
<br> than or equal to7 days ago, OR
<br>
<br> - A minimum of 10 days has passed since the initial positive test AND B. A minimum
<br> of 2 consecutive oropharyngeal swabs OR 2 consecutive nasopharyngeal swabs or 2
<br> saliva testing collected greater than or equal to 24 hours apart that are
<br> negative for SARS CoV-2 PCR A positive PCR requires restarting the series of
<br> swabs (wait 5 days to retest)
<br>
<br> 8. Specific Inclusion Criteria for Systemic Autoimmunity Diseases Group:
<br>
<br> - Age greater than or equal to 15 years with no upper age limit
<br>
<br> - Systemic lupus erythematosus (SLE): Meets at least 4 of 11 modified American
<br> College of Rheumatology (ACR) (1997) Revised Criteria for the Classification of
<br> Systemic Lupus Erythematosus or Systemic Lupus International Collaborating
<br> Clinics (SLICC) classification criteria for systemic lupus erythematosus.
<br>
<br> - Anti-neutrophil cytoplasmic antibody associated vasculitis (AAV): Meet Revised
<br> 1990 ACR criteria for Granulomatosis with polyangiitis (GPA) or the 2012 Chapel
<br> Hill Nomenclature for microscopic polyangiitis (MPA).
<br>
<br> - Idiopathic inflammatory myopathies (IIM):Meets the 2017 EULAR/ACR Classification
<br> Criteria for Adult and Juvenile idiopathic inflammatory myopathies and their
<br> major subgroups.
<br>
<br> - Primary Sjogren's syndrome (SS): Meets 2016 ACR criteria.
<br>
<br> - Progressive systemic sclerosis (PSS): ACR/EULAR 2013 Classification criteria.
<br>
<br> - Immunologically mediated kidney diseases (IKD): Based on results from kidney
<br> biopsy consistent with immunologically mediated nephrotic syndrome and/or
<br> glomerulonephritis
<br>
<br> - Rheumatoid arthritis (RA): Meet the 2010 ACR/EULAR Classification Criteria.
<br>
<br> - Systemic autoimmunity syndrome not otherwise specified (SA-NOS): Patients not
<br> utoimmune disease but with evidence of autoantibodies and clinical features
<br> suggestive of a systemic autoimmune disorder.
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> An individual who meets any of the following criteria will be excluded from participation
<br> in this study:
<br>
<br> 1. Pregnant and lactating subjects will be excluded because pregnancy and lactation
<br> modify immune responses and may interfere with correlations.
<br>
<br> 2. Concomitant medical problems which would confound the interpretation of studies
<br> gathered by this protocol. Included in this is the presence of HIV in the blood,
<br> active malignancies, or other significant medical conditions that may interferes with
<br> interpretation of studies.
<br>
<br> 3. Concomitant medical, surgical or other conditions for which inadequate facilities are
<br> available to support their care at NIH.
<br>
<br> 4. Inability or unwillingness to comply with follow up requirements (e.g. distance,
<br> social, physical limitations).
<br>
<br> 5. Any comorbidity of medical or psychological/psychiatric condition or treatment, that
<br> in the opinion of the Principal Investigator, would exclude the subjects from the
<br> research studies (e.g. Patient requiring urgent and/or acute medical care, surgical or
<br> other procedures)
<br>
<br> 6. Unwilling to participate in research studies or to provide research samples or data
<br>
<br> 7. Exclusion criteria for the (optional) vascular studies:
<br>
<br> -Healthy volunteers with known history of coronary artery disease, peripheral vascular
<br> disease or atherosclerosis.
<br>
<br> 8. Exclusion criteria for the (optional) FDGPET/CT scan:
<br>
<br> -Individuals younger than 18 years old will be excluded given the radiation exposure
<br>
<br> 9. Subjects with SAD and Healthy volunteers younger than 18 years old will be excluded
<br> from chest x-rays unless clinically indicated.
<br> | | Systemic Autoimmune Diseases | | Primary Objective: Characterize how COVID-19 modulates systemic inflammation, autoimmunity features, organ damage and vasculopathy in adult and pediatric patients with a previous diagnosis of systemic autoimmunity. Assess how subjects with syste... | | | | Yes | False | | |
| → | NCT04692779 | 1 March 2021→8 November 2021 | A Prospective Clinical Study to Explore Response to Prone Positioning in ARDS Patients | A Prospective Clinical Study to Explore the Mechanism of Patients' Response to Prone Positioning in ARDS Patients, Including COVID-19 | | Rush University Medical Center | 29/12/2020 | 20201229 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04692779 | Recruiting | No | 18 Years | N/A | All | January 31, 2021 | 60 | Observational | | | United States | ; | Tyler Weiss;Tyler Weiss | | Tyler_Weiss@rush.edu;Tyler_Weiss@rush.edu | 312-947-3027;312-563-2050 | |
<br> Inclusion Criteria:
<br>
<br> 1. Adult subjects 18 years and older, diagnosis of ARDS
<br>
<br> 2. endotracheally intubated and receiving assisted mechanical ventilation
<br>
<br> 3. meet criteria for prone positioning: PaO2/FIO2 (P/F ratio) of = 150 mm Hg with
<br> ventilator parameters of PEEP = 10 cm H2O and FiO2 of .60
<br>
<br> 4. receive an order for prone positioning.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnant
<br>
<br> 2. Tracheostomy
<br>
<br> 3. Receiving ECMO
<br>
<br> 4. Palliative care
<br>
<br> 5. Receive prone positioning more than once during intubation in an outside hospital
<br>
<br> 6. Receive invasive ventilation in an outside hospital for more than 72 hours
<br> | | Covid19;ARDS | Other: Lung Ultrasound (LUS) | Oxygenation and Lung Ultrasound Score (LUS) | | | | Yes | False | | |
| → | NCT04697927 | 18 January 2021→8 November 2021 | A Study of Risk Factors for the COVID-19 Virus Infection | Ascertainment of Epidemiologic Risk Information to Assess Susceptibility to and Severity of SARS-CoV-2 Infection | | Memorial Sloan Kettering Cancer Center | 04/01/2021 | 20210104 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04697927 | Recruiting | No | 18 Years | N/A | All | December 30, 2020 | 10000 | Observational | | | United States | ; | Jonine Bernstein, PhD;Jonine Bernstein, PhD | | ;bernstej@mskcc.org | ;646-888-8241 | Memorial Sloan Kettering Cancer Center; |
<br> Inclusion Criteria:
<br>
<br> MSK Patients
<br>
<br> - All individuals who have had at least one point of contact since January 1st 2019 as a
<br> patient, including visiting an MSK facility for treatment, clinical evaluation,
<br> follow-up or screening, COVID-related screening, or a telehealth visit. Household
<br> Members of MSK Patients
<br>
<br> - Individuals aged 18 or older
<br>
<br> - Currently reside in the same household of MSK patients enrolled onto this protocol
<br>
<br> - Have an email account
<br>
<br> Exclusion Criteria:
<br>
<br> - Impaired decision-making capacity as noted in EHR
<br>
<br> - Current MSK employee
<br> | | COVID-19 Infections in Cancer Patients | Other: Questionnaires | develop a comprehensive registry database | | | | No | False | | |
| → | NCT04704544 | 1 November 2021→8 November 2021 | Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis (EVOLVE) | Effectiveness of Tele-rheumatology for Delivering High Quality Rheumatology Care During the COVID-19 Crisis | | University of Alabama at Birmingham | 06/01/2021 | 20210106 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04704544 | Recruiting | No | 18 Years | N/A | All | September 15, 2021 | 320 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Care Provider). | N/A | United States | ; | JEFF FOSTER, MPH;Jeff Foster, MPH | | pjfoster@uabmc.edu;pjfoster@uabmc.edu | 2059966086;205-996-6086 | |
<br> Inclusion Criteria:
<br>
<br> - Diagnosis of rheumatic disease (e.g. rheumatoid arthritis, SLE)
<br>
<br> Exclusion Criteria:
<br>
<br> - unstable rheumatic disease that needs in-person visits (e.g. recent diagnosis of
<br> severe lupus nephritis)
<br>
<br> - expected in-office procedures (e.g., joint injection)
<br>
<br> - lack of access to phone
<br> | | Rheumatic Diseases | Other: Tele-rheumatology | Patient satisfaction | | | | Yes | False | | |
| → | NCT04705597 | 18 October 2021→8 November 2021 | Study to Evaluate the Safety, Tolerability, and Efficacy of BGE-175 in Hospitalized Adults With Coronavirus Disease 2019 (COVID-19) That Are Not in Respiratory Failure | A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Investigate the Efficacy and Safety of BGE-175 in Hospitalized Adults With COVID-19 | | BioAge Labs, Inc. | 04/01/2021 | 20210104 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04705597 | Recruiting | No | 50 Years | N/A | All | March 18, 2021 | 132 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | United States;Brazil;Argentina;Brazil;Argentina;United States→United States;Argentina;Brazil;Argentina;Brazil;United States | ; | Richard G Wilkerson, MD;Patrick Martin, MD | | ;patrick@bioagelabs.com | ;510-806-1502 | University of Maryland, College Park; |
<br> Inclusion Criteria:
<br>
<br> - Ability to voluntarily provide informed consent that is documented per local
<br> requirements
<br>
<br> - An understanding, ability, and willingness to fully comply with study procedures and
<br> restrictions
<br>
<br> - Hospitalized subjects with a confirmed SARS-CoV-2 infection
<br>
<br> - Laboratory (polymerase chain reaction [PCR]) confirmed infection with SARS-CoV-2
<br>
<br> - Age = 50 years
<br>
<br> - COVID-19 illness of any duration, and oxygen saturation measurements = 94% over 5
<br> minutes on room air (Note: low flow oxygen is permitted, but room air oxygen
<br> saturation must be = 94%)
<br>
<br> - Not in respiratory failure as defined by at least one of the following:
<br>
<br> 1. Respiratory failure defined by requiring at least one of the following:
<br>
<br> - Endotracheal intubation and mechanical ventilation
<br>
<br> - Oxygen delivered by high-flow nasal cannula at flow rates > 20 L/min with
<br> fraction of delivered oxygen = 0.5)
<br>
<br> - NIPPV
<br>
<br> - ECMO
<br>
<br> - Clinical diagnosis of respiratory failure (i.e., need for one of the
<br> preceding therapies, but preceding therapies are not being administered
<br> because it is unavailable in the current setting)
<br>
<br> 2. Hemodynamic compromise (defined by systolic blood pressure < 90 mm Hg, or
<br> diastolic blood pressure < 60 mm Hg) or requiring vasopressors
<br>
<br> 3. Multi-organ dysfunction/failure
<br>
<br> - Females subjects of childbearing potential must have a negative pregnancy test at
<br> screening or pre-treatment on Day 1
<br>
<br> - Male and female subjects of childbearing potential must agree to use methods of
<br> contraception that are consistent with local regulations for those participating in
<br> clinical studies
<br>
<br> Exclusion Criteria:
<br>
<br> - Participation in any other randomized, controlled clinical trial of an experimental
<br> treatment for COVID-19 (uncontrolled, compassionate use trials are allowed)
<br>
<br> - In the opinion of the investigator, progression to death is imminent and inevitable
<br> within the next 24 hours, irrespective of the provision of treatments
<br>
<br> - Currently participating in a vaccination trial for SARS-CoV-2
<br>
<br> - Subject requires oxygen administration by high flow nasal cannula (> 20 L/min)
<br>
<br> - Positive influenza test at screening
<br>
<br> - Positive for human immunodeficiency virus (HIV) that is not controlled with current
<br> treatment
<br>
<br> - Hepatitis B surface antigen, or Hepatitis C positive at the time of screening.
<br> Subjects who are positive for Hepatitis C but have Hepatitis C virus (HCV) RNA below
<br> the limit of quantitation may be enrolled. Subjects with Hepatitis B, but with
<br> undetectable viral load, may be enrolled.
<br>
<br> - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 × the upper
<br> limit of normal (ULN)
<br>
<br> - Stage 4 severe chronic kidney disease (i.e., estimated glomerular filtration rate
<br> [eGFR] < 30 mL/min) or acute renal failure resulting in eGFR < 30 mL/min
<br>
<br> - Serious comorbidity, including:
<br>
<br> 1. Myocardial infarction (within the last month)
<br>
<br> 2. Moderate or severe heart failure (New York Heart Association [NYHA] class III or
<br> IV)
<br>
<br> 3. Acute stroke (within the last month)
<br>
<br> 4. Uncontrolled malignancy. Uncontrolled malignancy would include cancers that are
<br> not considered in remission, or solid tumor or hematological malignancies with
<br> evidence of disease progression in the past 3 months (i.e., there is evidence of
<br> disease progression by Response Evaluation Criteria in Solid Tumours [RECIST] or
<br> equivalent relevant criterion for the type of malignancy), and are not considered
<br> effectively managed with ongoing treatment as determined by the investigator
<br>
<br> 5. Recent severe thromboembolic disease or evidence of severe thromboembolic disease
<br> defined as a current large vessel thromboembolic event or a thromboembolic event
<br> within the past 3 months (e.g., deep vein thrombosis [DVT], pulmonary embolism,
<br> ischemic stroke, transient ischemic attack) requiring interventional treatment.
<br> This exclusion does not prohibit prophylaxis for thromboembolic events, including
<br> those considered possible with concurrent SARS-CoV-2 infection.
<br>
<br> - History of severe allergic or anaphylactic reactions or hypersensitivity to the study
<br> drug
<br>
<br> - Consideration by the investigator, for any reason, that the subject is an unsuitable
<br> candidate to receive study treatment
<br> →
<br> Inclusion Criteria:
<br>
<br> - Ability to voluntarily provide informed consent that is documented per local
<br> requirements
<br>
<br> - An understanding, ability, and willingness to fully comply with study procedures and
<br> restrictions
<br>
<br> - Hospitalized subjects with a confirmed SARS-CoV-2 infection
<br>
<br> - Laboratory (polymerase chain reaction [PCR]) confirmed infection with SARS-CoV-2
<br>
<br> - Age = 50 years
<br>
<br> - COVID-19 illness of any duration, and oxygen saturation measurements = 94% over 5
<br> minutes on room air (Note: low flow oxygen is permitted, but room air oxygen
<br> saturation must be = 94%)
<br>
<br> - Not in respiratory failure as defined by at least one of the following:
<br>
<br> 1. Respiratory failure defined by requiring at least one of the following:
<br>
<br> - Endotracheal intubation and mechanical ventilation
<br>
<br> - Oxygen delivered by high-flow nasal cannula at flow rates > 20 L/min with
<br> fraction of delivered oxygen = 0.5)
<br>
<br> - NIPPV
<br>
<br> - ECMO
<br>
<br> - Clinical diagnosis of respiratory failure (i.e., need for one of the
<br> preceding therapies, but preceding therapies are not being administered
<br> because it is unavailable in the current setting)
<br>
<br> 2. Hemodynamic compromise (defined by systolic blood pressure < 90 mm Hg, or
<br> diastolic blood pressure < 60 mm Hg) or requiring vasopressors
<br>
<br> 3. Multi-organ dysfunction/failure
<br>
<br> - Females subjects of childbearing potential must have a negative pregnancy test at
<br> screening or pre-treatment on Day 1
<br>
<br> - Male and female subjects of childbearing potential must agree to use methods of
<br> contraception that are consistent with local regulations for those participating in
<br> clinical studies
<br>
<br> Exclusion Criteria:
<br>
<br> - Participation in any other randomized, controlled clinical trial of an experimental
<br> treatment for COVID-19 (uncontrolled, compassionate use trials are allowed)
<br>
<br> - In the opinion of the investigator, progression to death is imminent and inevitable
<br> within the next 24 hours, irrespective of the provision of treatments
<br>
<br> - Currently participating in a vaccination trial for SARS-CoV-2
<br>
<br> - Positive influenza test at screening
<br>
<br> - Positive for human immunodeficiency virus (HIV) that is not controlled with current
<br> treatment
<br>
<br> - Hepatitis B surface antigen, or Hepatitis C positive at the time of screening.
<br> Subjects who are positive for Hepatitis C but have Hepatitis C virus (HCV) RNA below
<br> the limit of quantitation may be enrolled. Subjects with Hepatitis B, but with
<br> undetectable viral load, may be enrolled.
<br>
<br> - Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 × the upper
<br> limit of normal (ULN)
<br>
<br> - Stage 4 severe chronic kidney disease (i.e., estimated glomerular filtration rate
<br> [eGFR] < 30 mL/min) or acute renal failure resulting in eGFR < 30 mL/min
<br>
<br> - Serious comorbidity, including:
<br>
<br> 1. Myocardial infarction (within the last month)
<br>
<br> 2. Moderate or severe heart failure (New York Heart Association [NYHA] class III or
<br> IV)
<br>
<br> 3. Acute stroke (within the last month)
<br>
<br> 4. Uncontrolled malignancy. Uncontrolled malignancy would include cancers that are
<br> not considered in remission, or solid tumor or hematological malignancies with
<br> evidence of disease progression in the past 3 months (i.e., there is evidence of
<br> disease progression by Response Evaluation Criteria in Solid Tumours [RECIST] or
<br> equivalent relevant criterion for the type of malignancy), and are not considered
<br> effectively managed with ongoing treatment as determined by the investigator
<br>
<br> 5. Recent severe thromboembolic disease or evidence of severe thromboembolic disease
<br> defined as a current large vessel thromboembolic event or a thromboembolic event
<br> within the past 3 months (e.g., deep vein thrombosis [DVT], pulmonary embolism,
<br> ischemic stroke, transient ischemic attack) requiring interventional treatment.
<br> This exclusion does not prohibit prophylaxis for thromboembolic events, including
<br> those considered possible with concurrent SARS-CoV-2 infection.
<br>
<br> - History of severe allergic or anaphylactic reactions or hypersensitivity to the study
<br> drug
<br>
<br> - Consideration by the investigator, for any reason, that the subject is an unsuitable
<br> candidate to receive study treatment
<br> | | Covid19 | Drug: BGE-175;Other: Placebo | Proportion of participants who have died or progressed to respiratory failure | | | | Yes | False | | |
| → | NCT04753242 | 1 November 2021→8 November 2021 | Psychosocial Care During the COVID-19 Pandemic in Acute Hospitals | Psychosocial Care During the COVID-19 Pandemic in Acute Hospitals - an International Online Survey of Psychosomatic, Psychiatric and Psychological Consultation and Liaison (C&L) Services | | University Hospital, Basel, Switzerland | 11/02/2021 | 20210211 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04753242 | Not recruiting | No | 18 Years | N/A | All | December 8, 2020 | 230 | Observational | | | Austria;Belgium;Canada;Finland;France;Germany;Greece;Iran, Islamic Republic of;Ireland;Italy;United Kingdom;Switzerland;Spain;Portugal;Poland;Norway;Italy;Ireland;Iran, Islamic Republic of;Greece;Germany;France;Finland;Canada;Belgium;Austria;United Kingdom;Switzerland;Spain;Portugal;Poland;Norway→Ireland;Italy;Norway;Poland;Portugal;Spain;Switzerland;United Kingdom;Iran, Islamic Republic of;Greece;Germany;France;Finland;Canada;Belgium;Austria;United Kingdom;Switzerland;Spain;Portugal;Poland;Norway;Italy;Ireland;Iran, Islamic Republic of;Greece;Germany;France;Finland;Canada;Belgium;Austria | | Rainer Schaefert, Prof. Dr. med. | | | | University Hospital, Basel, Switzerland |
<br> Inclusion Criteria:
<br>
<br> - heads of all psychosomatic, psychiatric and psychological C&L services in acute care
<br> hospitals across all participating countries
<br>
<br> Exclusion Criteria:
<br>
<br> - None
<br> | | Covid-19;COVID-19 Related Psychosocial Burden | Other: Online survey questionnaire | Structural and process quality of COVID-19 related psychosocial C&L services | | | | No | False | | |
| → | NCT04754594 | 1 November 2021→8 November 2021 | Study to Evaluate the Safety, Tolerability, and Immunogenicity of SARS CoV-2 RNA Vaccine Candidate (BNT162b2) Against COVID-19 in Healthy Pregnant Women 18 Years of Age and Older | A PHASE 2/3, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE (BNT162b2) AGAINST COVID-19 IN HEALTHY PREGNANT WOMEN 18 YEARS OF AGE AND OLDER | | BioNTech SE | 09/02/2021 | 20210209 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04754594 | Recruiting | No | N/A | N/A | All | February 16, 2021 | 700 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | United States;Brazil;South Africa;Spain;United Kingdom;Brazil;South Africa;Spain;United Kingdom;United States | ; | Pfizer CT.gov Call Center;Pfizer CT.gov Call Center | | ;ClinicalTrials.gov_Inquiries@pfizer.com | ;1-800-718-1021 | Pfizer; |
<br> Inclusion Criteria:
<br>
<br> 1. Healthy women =18 years of age who are between 24 0/7 and 34 0/7 weeks' gestation on
<br> the day of planned vaccination, with an uncomplicated, singleton pregnancy, who are at
<br> no known increased risk for complications.
<br>
<br> 2. Participants who are willing and able to comply with scheduled visits, treatment plan,
<br> laboratory tests, and other study procedures.
<br>
<br> 3. Healthy participants who are determined by medical history, physical examination, and
<br> clinical judgment to be appropriate for inclusion in the study
<br>
<br> 4. Documented negative HIV antibody test (Phase 2 only), syphilis test, and HBV surface
<br> antigen test during this pregnancy and prior to randomization
<br>
<br> 5. Participant is willing to give informed consent for her infant to participate in the
<br> study
<br>
<br> 6. Capable of giving signed informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Other medical or psychiatric condition including recent (within the past year) or
<br> active suicidal ideation/behavior or laboratory abnormality that may increase the risk
<br> of study participation or, in the investigator's judgment, make the participant
<br> inappropriate for the study.
<br>
<br> 2. Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result
<br> was not available) or microbiological (based on COVID-19 symptoms/signs and a positive
<br> SARS-CoV-2 NAAT result) diagnosis of COVID 19.
<br>
<br> 3. History of severe adverse reaction associated with a vaccine and/or severe allergic
<br> reaction (eg, anaphylaxis) to any component of the study intervention or any related
<br> vaccine.
<br>
<br> 4. Participants with known or suspected immunodeficiency.
<br>
<br> 5. Bleeding diathesis or condition associated with prolonged bleeding that would in the
<br> opinion of the investigator contraindicate intramuscular injection.
<br>
<br> 6. Previous vaccination with any coronavirus vaccine.
<br>
<br> 7. Receipt of medications intended to prevent COVID 19.
<br>
<br> 8. Receipt of blood/plasma products or immunoglobulin, from 60 days before administration
<br> of study intervention, or planned receipt through delivery, with 1 exception, anti-D
<br> immunoglobulin (eg, RhoGAM), which can be given at any time.
<br>
<br> 9. Current alcohol abuse or illicit drug use.
<br>
<br> 10. Participants who receive treatment with immunosuppressive therapy, including cytotoxic
<br> agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or
<br> planned receipt through the postvaccination blood draw.
<br>
<br> 11. Participation in other studies involving study intervention within 28 days prior to
<br> study entry and/or during study participation.
<br>
<br> 12. Previous participation in other studies involving study intervention containing LNPs.
<br>
<br> 13. Investigator site staff or Pfizer employees directly involved in the conduct of the
<br> study, site staff otherwise supervised by the investigator, and their respective
<br> family members.
<br>
<br> 14. Participants whose unborn baby has been fathered by investigational site staff members
<br> directly involved in the conduct of the study or their family members, site staff
<br> members otherwise supervised by the investigator, or Pfizer employees directly
<br> involved in the conduct of the study.
<br> | | SARS-CoV-2 Infection;COVID-19;Maternal Immunization | Biological: BNT162b2;Other: Placebo | Demonstrate immunobridging of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection;Demonstrate immunobridging of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection.;Percentage of maternal participants reporting serious adverse events;Percentage of maternal participants reporting adverse events;Percentage of maternal participants reporting systemic events;Percentage of maternal participants reporting: Local reactions→Percentage of maternal participants reporting: Local reactions;Percentage of maternal participants reporting systemic events;Percentage of maternal participants reporting adverse events;Percentage of maternal participants reporting serious adverse events;Demonstrate immunobridging of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study without evidence of past SARS-CoV-2 infection.;Demonstrate immunobridging of immune response in pregnant women compared to nonpregnant female participants from the C4591001 study with and without evidence of prior SARS-CoV-2 infection | | | | Yes | False | | |
| → | NCT04762680 | 7 September 2021→8 November 2021 | Study of Recombinant Protein Vaccines With Adjuvant as a Primary Series and as a Booster Dose Against COVID-19 in Adults 18 Years of Age and Older | Immunogenicity and Safety of SARS-CoV-2 Recombinant Protein Vaccines With AS03 Adjuvant in Adults 18 Years of Age and Older as a Primary Series and Immunogenicity and Safety of a Booster Dose of SARS-CoV-2 Adjuvanted Recombinant Protein Vaccines (Two Monovalent and One Bivalent) | VAT00002 | Sanofi Pasteur, a Sanofi Company | 18/02/2021 | 20210218 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04762680 | Recruiting | No | 18 Years | N/A | All | February 24, 2021 | 5414 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States;Australia;Honduras;Australia;Honduras;United States;Panama→Panama;United States;United Kingdom;Spain;Kenya;Honduras;France;Australia;United Kingdom;Spain;Kenya;Honduras;France;Australia;United States | ; | Clinical Sciences & Operations;Trial Transparency email recommended (Toll free number for US & Canada) | | ;Contact-US@sanofi.com | ;800-633-1610 | Sanofi; |
<br> Inclusion Criteria:
<br>
<br> - Aged 18 years or older on the day of inclusion.
<br>
<br> - A female participant is eligible to participate if she is not pregnant or
<br> breastfeeding and one of the following conditions applies:
<br>
<br> Is of non-childbearing potential. To be considered of non-childbearing potential, a female
<br> mut be post-menopausal for at least 1 year or surgically sterile.
<br>
<br> OR Is of childbearing potential and agrees to use an effective contraceptive method or
<br> abstinence from at least 4 weeks prior to the first vaccination until at least 12 weeks
<br> after the second vaccination. A participant of childbearing potential must have a negative
<br> highly sensitive pregnancy test (urine or serum as required by local regulation) within 4
<br> hours before any dose of study intervention.
<br>
<br> - Informed consent form has been signed and dated.
<br>
<br> - Able to attend all scheduled visits and to comply with all study procedures.
<br>
<br> - SARS-CoV-2 rapid serodiagnostic test performed at the time of enrollment to detect
<br> presence of SARS-CoV-2 antibodies (Original Phase 2 Cohort).
<br>
<br> - For persons living with human immunodeficiency virus (HIV), stable HIV infection
<br> determined by participant currently on antiretrovirals with CD4 count > 200/mm3.
<br>
<br> - Does not intend to receive an authorized/approved COVID-19 vaccine from first
<br> vaccination to 3 weeks after the second vaccination despite encouragement by the
<br> investigator to receive the authorized vaccine available to them at the time of
<br> enrollment.
<br>
<br> - Supplemental cohorts: for participants originally enrolled in the Phase II cohort of
<br> the study, informed consent has to be signed and dated for transitioning to
<br> Supplemental Cohort 2.
<br>
<br> - Supplemental cohorts, booster arms: received a complete primary vaccination series
<br> with an authorized/conditionally approved mRNA COVID-19 vaccine (mRNA-1273 [Moderna]
<br> or BNT162b2 [Pfizer/BioNTech]) or adenovirus-vectored COVID-19 vaccine (ChAdOx1
<br> nCoV-19 [Oxford University/AstraZeneca] or Ad26.CoV2.S [J&J/Janssen]), with the last
<br> dose administered a minimum of 4 months prior to inclusion but not longer than 10
<br> months prior to inclusion.
<br>
<br> Exclusion Criteria:
<br>
<br> - Known systemic hypersensitivity to any of the vaccine components, or history of a
<br> life-threatening reaction to a vaccine containing any of the same substances.
<br>
<br> - Dementia or any other cognitive condition at a stage that could interfere with
<br> following the trial procedures based on Investigator or designee's judgment.
<br>
<br> - Self-reported thrombocytopenia, contraindicating intramuscular (IM) vaccination based
<br> on Investigator's judgment.
<br>
<br> - Bleeding disorder, or receipt of anticoagulants in the past 21 days preceding
<br> inclusion, contraindicating IM vaccination based on Investigator's judgment.
<br>
<br> - Unstable acute or chronic illness that in the opinion of the Investigator or designee
<br> poses additional risk as a result of participation or that could interfere with the
<br> study procedures.
<br>
<br> - Receipt of solid-organ or bone marrow transplants in the past 180 days.
<br>
<br> - Receipt of anti-cancer chemotherapy in the last 90 days.
<br>
<br> - Moderate or severe acute illness/infection (according to investigator judgment) on the
<br> day of vaccination or febrile illness (temperature = 38.0°C [= 100.4°F]). A
<br> prospective participant should not be included in the trial until the condition has
<br> resolved or the febrile event has subsided.
<br>
<br> - Receipt of any vaccine in the 30 days preceding or on the day of the first study
<br> vaccination or planned receipt of any vaccine between the first study vaccination and
<br> in the 30 days following the second study vaccination except for influenza
<br> vaccination, which may be received at any time in relation to study intervention.
<br>
<br> - Applicable to Original Phase II Cohort, Supplemental Cohort 1 and Cohort 2 Comparator
<br> Group, and Supplemental Variant Prime Cohort 3 Groups: Prior administration of a
<br> coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East Respiratory Syndrome
<br> [MERS-CoV]).
<br>
<br> - Participation at the time of trial enrollment (or in the 30 days preceding the first
<br> trial vaccination) or planned participation during the present trial period in another
<br> clinical trial investigating a vaccine, drug, medical device, or medical procedure.
<br>
<br> - Exclusion criterion for the Supplemental Cohort 1 and Cohort 2 comparator group and
<br> for the 3 Supplemental Variant Prime Cohort 3 groups: positive rapid diagnostic test
<br> for SARS-CoV-2 antibodies at time of enrollment.
<br>
<br> - Exclusion criterion for participants in Supplemental Cohort 2 who were primed as
<br> participant in the Original Phase II Cohort of the present study): Receipt of
<br> authorized/conditionally approved COVID-19 vaccine after enrollment in Original Phase
<br> 2 Cohort.
<br>
<br> - Exclusion criterion for all Booster groups: Documented virologically-confirmed
<br> SARS-CoV-2 infection (by NAAT) after first dose of primary immunization.
<br>
<br> The above information is not intended to contain all considerations relevant to a patient's
<br> potential participation in a clinical trial.
<br> | | COVID-19 (Healthy Volunteers) | Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 1;Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 2;Biological: SARS-CoV-2 recombinant protein vaccine Phase 2 Formulation 3;Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage A;Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03, Dosage A;Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03, Dosage A;Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (D614)-AS03, Dosage B;Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03, Dosage B;Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, bivalent (D614+B.1.351)-AS03, Dosage B;Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 1;Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 2;Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 3;Biological: SARS-CoV-2 adjuvanted recombinant protein vaccine, monovalent (B.1.351)-AS03 Alternative Exploratory Formulation 4 | Presence of immediate adverse events;Presence of solicited injection site or systemic reactions;Presence of unsolicited adverse events;Presence of serious adverse events;Presence of adverse events of special interest;Presence of medically-attended adverse events;Neutralizing antibody titer at Day 1;Neutralizing antibody titer at Day 36;Neutralizing antibody titer fold-rise post-vaccination;2-fold rise and 4-fold-rise in neutralization antibody titer;Responders, as determined by neutralizing antibody titers at Day 36;Neutralizing antibody titer at Day 1 (pre-booster injection);Neutralizing antibody titer at Day 15 (post-booster injection);Neutralizing antibody titer at Day 36 (Cohorts 1 and 2 Comparator Group and all Cohort 3 arms);Responders, as determined by neutralizing antibody titers at Day 36 (Cohorts 1 and 2 Comparator Group and all Cohort 3 arms)→Responders, as determined by neutralizing antibody titers at Day 36 (Cohorts 1 and 2 Comparator Group and all Cohort 3 arms);Neutralizing antibody titer at Day 36 (Cohorts 1 and 2 Comparator Group and all Cohort 3 arms);Neutralizing antibody titer at Day 15 (post-booster injection);Neutralizing antibody titer at Day 1 (pre-booster injection);Responders, as determined by neutralizing antibody titers at Day 36;2-fold rise and 4-fold-rise in neutralization antibody titer;Neutralizing antibody titer fold-rise post-vaccination;Neutralizing antibody titer at Day 36;Neutralizing antibody titer at Day 1;Presence of medically-attended adverse events;Presence of adverse events of special interest;Presence of serious adverse events;Presence of unsolicited adverse events;Presence of solicited injection site or systemic reactions;Presence of immediate adverse events | | | | Yes | False | | |
| → | NCT04762771 | 19 April 2021→8 November 2021 | Colchicine for the Treatment of Cardiac Injury in Hospitalized Patients With COVID-19 (COLHEART-19) | Open-label (Unblinded) Randomization to Treatment of Colchicine Plus Current Care Per Institution Treating Physicians vs. Current Care Per Institution Treating Physicians (Control Arm) | Colheart-19 | Baptist Health South Florida | 18/02/2021 | 20210218 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04762771 | Not recruiting | No | 18 Years | 99 Years | All | December 1, 2020 | 75 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1/Phase 2 | United States | ; | Sandra Chaparro, MD;Raul E Herrera, MD | | ; | ; | Baptist Health South Florida;Baptist Health South Florida |
<br> Inclusion Criteria:
<br>
<br> - Men and Women = 18 years of age
<br>
<br> - Covid-19 Positive
<br>
<br> - Hospitalized patients able to provide informed consent
<br>
<br> - Cardiac injury (as evidenced by any of the following)
<br>
<br> 1. Elevated troponin level
<br>
<br> 2. Elevated BNP level
<br>
<br> 3. New ischemic or arrhythmogenic ECG/telemetry changes
<br>
<br> 4. New decrease in LVEF or new pericardial effusion on echocardiogram
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use
<br> adequate contraception, which includes:
<br>
<br> 1. Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
<br>
<br> 2. Hormone method with a barrier method
<br>
<br> 3. Two barrier methods
<br>
<br> 4. If a partner's vasectomy is the chosen method of contraception, a hormone or
<br> barrier method must also be used in conjunction
<br>
<br> - History of severe hematologic or neuromuscular disorder
<br>
<br> - Co-administration of CYPA3A4 and P-glycoprotein transport inhibitor
<br>
<br> - Severe renal impairment with concomitant hepatic impairment
<br>
<br> - Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or
<br> hepatic impairment
<br> →
<br> Inclusion Criteria:
<br>
<br> - Men and Women = 18 years of age
<br>
<br> - Covid-19 Positive
<br>
<br> - Hospitalized patients able to provide informed consent
<br>
<br> - Cardiac injury (as evidenced by any of the following)
<br>
<br> 1. Elevated troponin level
<br>
<br> 2. Elevated BNP level
<br>
<br> 3. New ischemic or arrhythmogenic ECG/telemetry changes
<br>
<br> 4. New decrease in Left Ventricular Ejection Fraction (LVEF) or new pericardial
<br> effusion on echocardiogram
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnancy, breastfeeding mothers, and women of childbearing age who are unable to use
<br> adequate contraception, which includes:
<br>
<br> 1. Intrauterine devices (IUD), contraceptive implants, or tubal sterilization
<br>
<br> 2. Hormone method with a barrier method
<br>
<br> 3. Two barrier methods
<br>
<br> 4. If a partner's vasectomy is the chosen method of contraception, a hormone or
<br> barrier method must also be used in conjunction
<br>
<br> - History of severe hematologic or neuromuscular disorder
<br>
<br> - Co-administration of Cytochrome P450 3A4 (CYPA3A4) and P-glycoprotein transport
<br> inhibitor
<br>
<br> - Severe renal impairment with concomitant hepatic impairment
<br>
<br> - Concurrent use of colchicine and strong or P-glycoprotein inhibitor with renal or
<br> hepatic impairment
<br> | | Covid19 | Drug: Colchicine | Mechanical Circulatory Support;Mechanical Ventilation;Mortality→Mortality;Mechanical Ventilation;Mechanical Circulatory Support | | | | No | False | | |
| → | NCT04765384 | 1 November 2021→8 November 2021 | A Study of Ad26.COV2.S in Healthy Pregnant Participants (COVID-19) | An Open-label, Phase 2 Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S in Healthy Pregnant Participants | HORIZON 1 | Janssen Vaccines & Prevention B.V. | 19/02/2021 | 20210219 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04765384 | Recruiting | No | 18 Years | 45 Years | Female | August 27, 2021 | 400 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 2 | United Kingdom;Spain;Finland;Canada;Australia;United States;South Africa;Brazil;South Africa;Brazil;United States→United States;Brazil;South Africa;Brazil;South Africa;United States;Australia;Canada;Finland;Spain;United Kingdom | ; | Janssen Vaccines & Prevention B.V. Clinical Trial;Study Contact | | ;JNJ.CT@sylogent.com | ;844-434-4210 | Janssen Vaccines & Prevention B.V.; |
<br> Inclusion Criteria:
<br>
<br> - If on medication for a condition, the medication dose must have been stable for at
<br> least 12 weeks preceding vaccination and expected to remain stable for the duration of
<br> the study
<br>
<br> - Participant will be included on the basis of physical examination, medical history,
<br> and vital signs
<br>
<br> - Participant will be at second or third trimester of pregnancy, that is, Week 16 to
<br> Week 38 of gestation (inclusive), at the time of vaccination, based on ultrasound at
<br> the time of screening (unless performed elsewhere within 28-days prior to vaccination)
<br>
<br> - Participant agrees to not donate bone marrow, blood, and blood products from the first
<br> study vaccine administration until 3 months after receiving the last dose of study
<br> vaccine
<br>
<br> - Participant must be willing to provide verifiable identification, has means to be
<br> contacted and to contact the investigator during the study
<br>
<br> Exclusion Criteria:
<br>
<br> - Participants with medical or obstetric histories that put them at higher risk for
<br> maternal or fetal complications (example, preeclampsia, premature birth during
<br> previous pregnancy)
<br>
<br> - Participant with abnormal pregnancy screening test (example, ultrasound fetal
<br> abnormalities, maternal blood screen)
<br>
<br> - Participant has a history of malignancy within 5 years before screening (exceptions
<br> are squamous and basal cell carcinomas of the skin and carcinoma in situ of the
<br> cervix, or malignancy, which is considered cured with minimal risk of recurrence
<br>
<br> - Participant has a known or suspected allergy or history of anaphylaxis or other
<br> serious adverse reactions to vaccines or their excipients (including specifically the
<br> excipients of the study vaccine)
<br>
<br> - Participant has a history of any serious, chronic, or progressive neurological
<br> disorders or seizures including Guillain-Barre syndrome, with the exception of febrile
<br> seizures during childhood
<br>
<br> - Participant has a positive diagnostic test result (polymerase chain reaction [PCR]
<br> based viral ribonucleic acid [RNA] detection) severe acute respiratory syndrome
<br> coronavirus-2 (SARS-CoV-2) infection at screening or Day 1 (if more than 4 days in
<br> between)
<br>
<br> - Participant has a history of thrombosis with thrombocytopenia syndrome (TTS),
<br> including cerebral venous sinus thrombosis (CVST), or heparin-induced thrombocytopenia
<br> (HIT)
<br>
<br> - Participant has a history of capillary leak syndrome (CLS)
<br> | | COVID-19 Prevention | Biological: Ad26.COV2.S | Number of Participants with Antibody GMC 14 Days After the Second Vaccination;Number of Participants with Antibody Geometric Mean Concentration (GMC) 28 Days After the First Vaccination;Serological Response to Vaccination as Measured by ELISA 14 Days After the Second Vaccination;Serological Response to Vaccination as Measured by Enzyme-linked Immunosorbent Assay (ELISA) 28 Days After the First Vaccination;Number of Participants with AEs leading to Discontinuation;Number of Participants with Medically-attended Adverse Events (MAAEs);Number of Participants with Adverse Events of Special Interest (AESIs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Unsolicited AEs;Number of Participants with Solicited Systemic AEs for 7 Days After Each Vaccination or Until Resolution;Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Each vaccination or Until Resolution | | | | Yes | False | | |
| → | NCT04784559 | 1 November 2021→8 November 2021 | Trial to Determine the Efficacy/Safety of Plitidepsin vs Control in Patients With Moderate COVID-19 Infection | A Phase 3, Multicentre, Randomised, Controlled Trial to Determine the Efficacy and Safety of Two Dose Levels of Plitidepsin Versus Control in Adult Patient Requiring Hospitalisation for Management of Moderate COVID-19 Infection | Neptuno | PharmaMar | 04/03/2021 | 20210304 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04784559 | Recruiting | No | 18 Years | N/A | All | June 4, 2021 | 609 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | Spain;Turkey;Italy;South Africa;Romania;Portugal;Peru;Mexico;Greece;France;Colombia;Bulgaria;Brazil;Argentina;Turkey;Spain;South Africa;Romania;Portugal;Peru;Mexico;Greece;France;Colombia;Bulgaria;Brazil;Argentina | ; | José Jimeno Doñaque, MD, PhD;José Jimeno Doñaque, MD, PhD | | ;clinicaltrials@pharmamar.com | ;+34918466000 | PharmaMar; |
<br> Inclusion Criteria:
<br>
<br> 1. Signed informed consent obtained prior to initiation of any study-specific procedures
<br> and study treatment
<br>
<br> 2. Documented diagnosis of SARS-CoV-2 infection, determined by either qualitative
<br> polymerase chain reaction (PCR) or antigen test by local laboratory, from oro
<br> nasopharyngeal exudate collected no more than 72 hours prior to study treatment on Day
<br> 1
<br>
<br> 3. Patient meets category 5 on the 11-point WHO Clinical Progression Scale: requires
<br> hospitalization and oxygen by mask or nasal prongs/cannula
<br>
<br> 4. A maximum of 10 days from onset of COVID-19 symptoms to initiation of study treatment
<br> on Day 1
<br>
<br> 5. Male or female aged =18 years
<br>
<br> 6. Adequate bone marrow, liver, kidney, and metabolic function, defined by the following
<br> tests performed at local laboratory:
<br>
<br> - Absolute neutrophil count =1000/mm^3 (1.0 x 10^9/L)
<br>
<br> - Lymphocyte count =500/mm^3 (0.5 x 10^9/L)
<br>
<br> - Platelet count =100 000/mm^3 (100 x 10^9/L)
<br>
<br> - Haemoglobin >9.0 g/dL
<br>
<br> - Alanine transaminase (ALT), aspartate transaminase (AST) =3 x upper limit of
<br> normal (ULN)
<br>
<br> - Serum bilirubin =1 x ULN
<br>
<br> - Calculated creatinine clearance =30 mL/min (Cockcroft and Gault formula)
<br>
<br> - Creatine phosphokinase =2.5 x ULN except if the patient has had recent (ie, in
<br> the last week) shivering episodes or trauma. In that case, the level of creatine
<br> phosphokinase (CPK) should be =5 x ULN).
<br>
<br> 7. Agree not to participate in another interventional clinical trial through Day 31
<br>
<br> 8. Females of reproductive capacity must have a negative serum or urine pregnancy test by
<br> local laboratory at study enrolment and must be non-lactating
<br>
<br> 9. Females and males with partners of child-bearing potential must use effective
<br> contraception while on study treatment and for 6 months after last dose of
<br> plitidepsin. Patients in the control arm must use effective contraception at the time
<br> indicated in the approved product information (summary of product characteristics
<br> [SmPC] or leaflet). If no information is available in the approved product
<br> information, patients in the control arm must use effective contraception for at least
<br> one week after the study completion or the time indicated based on the investigator's
<br> discretion.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subjects with a pre-baseline (ie, in the prior month) impairment in general health
<br> condition for whatever reason except COVID 19, requiring either assistance for daily
<br> living activities (Barthel index <90/100) or chronic oxygen therapy
<br>
<br> 2. Having received treatment for COVID 19 in another clinical trial in the prior 4 weeks,
<br> except documented allocation in a placebo arm.
<br>
<br> 3. Evidence of respiratory failure at the time of randomisation, based on resource
<br> utilisation requiring at least one of the following: endotracheal intubation and
<br> mechanical ventilation, oxygen delivered by high-flow nasal cannula, noninvasive
<br> positive pressure ventilation, ECMO, or clinical diagnosis of respiratory failure (ie,
<br> clinical need for one of the preceding therapies, but preceding therapies not able to
<br> be administered in setting of resource limitation)
<br>
<br> 4. Patients with severe COVID 19, meeting score >5 on the 11 point WHO Clinical
<br> Progression Scale or presenting during the screening any of clinical signs indicative
<br> of severe systemic illness, such as respiratory rate =30 per minute, heart rate =125
<br> per minute, or PaO2/FiO2 <300
<br>
<br> 5. Patients receiving treatment with antiviral therapy against SARS-CoV-2 (either small
<br> molecules or antibodies, convalescent plasma, monoclonal antibodies, IL 6 receptor
<br> inhibitor, or immunomodulatory drugs) within 2 weeks before enrolment. Prior
<br> administration of dexamethasone or equivalent glucocorticoid might be acceptable if:
<br>
<br> 1. The total daily dose is not higher than 6 mg of dexamethasone base (equivalent to
<br> dexamethasone phosphate 7.2 mg/day) or equivalent glucocorticoid
<br>
<br> 2. The duration of the treatment does not exceed 72 hours prior to study treatment
<br> Day 1
<br>
<br> 6. History of live vaccination within the last 4 weeks prior to study enrolment.
<br> Regulatory approved, nonreplicative viral vector based vaccines are allowed if given
<br> not earlier than 1 week previous to Day 1.
<br>
<br> 7. Patients receiving treatment with chloroquine or derivatives within 8 weeks before
<br> enrolment or during the study
<br>
<br> 8. Patients receiving treatment with strong cytochrome P450 3A4 ( CYP3A4) inhibitors or
<br> inducers
<br>
<br> 9. Viral illness (other than COVID 19) requiring therapy, except for patients with
<br> treated and adequately controlled (undetectable) human immunodeficiency virus
<br> infection
<br>
<br> 10. Patients with uncontrolled known primary or secondary immunodeficiency, including
<br> chronic treatment with glucocorticoids (ie, prednisone at a daily dose of >10 mg for
<br> >1 month, or other glucocorticoid at equipotent dose)
<br>
<br> 11. Any of the following cardiac conditions or risk factors:
<br>
<br> - Sinus bradycardia (<50 beats/min), sinus nodal dysfunction (sick sinus disease),
<br> atrioventricular block of any degree (PR >200 msec), or any other bradyarrhythmia
<br> (<50 beats/min), except for patients with permanent pacemakers;
<br>
<br> - Cardiac infarction, cardiac surgery or cardiac insufficiency episode within the
<br> last 6 months;
<br>
<br> - Known abnormal value of left ventricular ejection fraction (LVEF < LLN), unless
<br> documented confirmation of recovery (LVEF > LLN) in the previous month;
<br>
<br> - QT interval corrected using Fridericia's formula (QTcF) >450 msec for males or
<br> >470 msec for females, based on triplicate 12-lead ECG at screening
<br>
<br> - History of known congenital or acquired QT prolongation
<br>
<br> - Uncorrected hypokalaemia, hypocalcaemia (adjusted), and/or hypomagnesemia at
<br> screening
<br>
<br> - Concomitant treatments with drugs known to be associated with a risk of QT
<br> prolongation or cardiac arrhythmia
<br>
<br> - Troponin test performed at local laboratory > 1.5 x ULN
<br>
<br> 12. Pre-existing neuropathies of any type Grade =2 according to National Cancer Institute
<br> Common Terminology Criteria for Adverse Events (NCI CTCAE) version 5.0
<br>
<br> 13. Hypersensitivity to the active ingredient or any of the excipients (mannitol,
<br> macrogolglycerol hydroxystearate, and ethanol)
<br>
<br> 14. Females who are pregnant (negative serum or urine pregnancy test required for all
<br> females of child-bearing potential at screening) or breast feed | | COVID-19 Infection | Drug: Plitidepsin;Drug: Dexamethasone;Drug: Remdesivir;Drug: Favipiravir | Percentage of patients who achieve complete recovery: | | | | Yes | False | | |
| → | NCT04791436 | 22 March 2021→8 November 2021 | Oral and Olfactory Complications of Recovered COVID-19 Patients | Oral and Olfactory Complications of Recovered COVID-19 Patients: A Prospective Cohort Study | | University of Giessen | 07/03/2021 | 20210307 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04791436 | Not recruiting→Recruiting | No | 18 Years | N/A | All | March 1, 2021→May 1, 2021 | 402 | Observational | | | →Germany | → ; | Sameh Attia, MSc→Sameh Attia, MSc;Sameh Attia | | Sameh.Attia@dentist.med.uni-giessen.de→Sameh.Attia@dentist.med.uni-giessen.de; | 00496419946110→00496419946110; | |
<br> Inclusion Criteria:
<br>
<br> - All adult COVID-19 recovery patients (exceeding the age of 18) will be included in the
<br> study. The time between illness and study recruitment shall be at least 3 months.
<br>
<br> Exclusion Criteria:
<br>
<br> - Exclusion criteria are psychiatric or neurological diseases, previous trauma, surgery
<br> or radiotherapy in the oral or nasal cavities, pre-existing taste or smell
<br> dysfunctions or chronic rhinosinusitis.
<br> | | Oral Complication;Dysgeusia;Olfactory Disorder | Diagnostic Test: Gustatory and olfactory function test;Diagnostic Test: Molecular assessment of saliva | Olfactory function;Gustatory function;Oral mucocutaneous lesions;Periodontal health | | | | Yes | False | | |
| → | NCT04798027 | 27 September 2021→8 November 2021 | Study of mRNA Vaccine Formulation Against COVID-19 in Healthy Adults 18 Years of Age and Older | Immunogenicity and Safety of the First-in-Human SARS-CoV-2 mRNA Vaccine Formulation in Healthy Adults 18 Years of Age and Older | VAW00001 | Sanofi Pasteur, a Sanofi Company | 11/03/2021 | 20210311 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04798027 | Recruiting | No | 18 Years | N/A | All | March 12, 2021 | 333 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | United States;Honduras;Brazil;Australia;Honduras;Brazil;Australia;United States | ; | Clinical Sciences & Operations;Trial Transparency email recommended (Toll free number for US & Canada) | | ;Contact-US@sanofi.com | ;800-633-1610 | Sanofi; |
<br> Inclusion criteria :
<br>
<br> - Aged = 18 years on the day of inclusion.
<br>
<br> - A female participant is eligible to participate if she is not pregnant or
<br> breastfeeding and one of the following conditions applies:
<br>
<br> - Is of non-childbearing potential. To be considered of non-childbearing potential, a
<br> female must be pre-menarche or post-menopausal for at least 1 year, or surgically
<br> sterile.
<br>
<br> OR
<br>
<br> - Is of childbearing potential and agrees to use an effective contraceptive method or
<br> abstinence from at least 4 weeks prior to the first vaccination until at least 12
<br> weeks after the last vaccination.
<br>
<br> A participant of childbearing potential must have a negative highly sensitive pregnancy
<br> test (urine or serum as required by local regulation) within 8 hours before the study
<br> intervention.
<br>
<br> - Informed Consent Form has been signed and dated.
<br>
<br> - Participant not eligible to receive, based on local guidance, or if eligible does not
<br> intend to receive an authorized/approved COVID-19 vaccine from first vaccination until
<br> completion of the key timepoint of Day 43 of follow-up of this study.
<br>
<br> Exclusion criteria:
<br>
<br> - History of COVID-19 disease or prior severe acute respiratory syndrome coronavirus 2
<br> (SARS-CoV-2) infection confirmed serologically.
<br>
<br> - Known or suspected congenital or acquired immunodeficiency; or receipt of
<br> immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy,
<br> within the preceding 6 months; or long-term systemic corticosteroid therapy
<br> (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
<br>
<br> - Chronic illness or condition considered to potentially increase the risk for severe
<br> COVID illness or that, in the opinion of the Investigator, is at a stage where it
<br> might interfere with study conduct or completion.
<br>
<br> - Known liver disease or fatty liver.
<br>
<br> - Positive test for chronic active Hepatitis B surface antigen, Hepatitis B core
<br> antibody, Hepatitis C antibody, or human immunodeficiency virus (HIV) antibody from
<br> blood work collected at screening visit.
<br>
<br> - Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion,
<br> contraindicating intramuscular vaccination based on Investigator's judgment.
<br>
<br> - Receipt of immuneglobulins, blood or blood-derived products in the past 3 months.
<br>
<br> - Prior administration of a coronavirus vaccine (SARS-CoV-2, SARS-CoV, Middle East
<br> Respiratory Syndrome coronavirus [MERS-CoV]).
<br>
<br> - Receipt of any vaccine in the 30 days preceding the first study vaccination or planned
<br> receipt of any vaccine in the 30 days following the last study vaccination except for
<br> influenza vaccination, which may be received at least 2 weeks before and a minimum of
<br> 2 weeks after study vaccines.
<br>
<br> - Receipt of any therapy known to have in-vitro antiviral activity against SARS-CoV-2
<br> within 72 hours prior to the first blood draw or planned use of such therapy 72 hours
<br> prior to study immunogenicity blood draws at Day 22 and Day 36.
<br>
<br> - Residence in a nursing home or long-term care facility.
<br>
<br> - Health care workers providing direct patient care for COVID-19 patients.
<br>
<br> The above information is not intended to contain all considerations relevant to a patient's
<br> potential participation in a clinical trial.
<br> | | COVID-19 | Biological: SARS-CoV-2 mRNA vaccine formulation 1;Biological: SARS-CoV-2 mRNA vaccine formulation 2;Biological: SARS-CoV-2 mRNA vaccine formulation 3;Biological: Placebo (0.9% normal saline) | Occurrence of neutralizing antibody seroconversion;2-fold and 4-fold rise in neutralizing antibody titer;Fold-rise in neutralizing antibody titer;Neutralizing antibody titer;Presence of out-of-range biological test results;Presence of serious adverse events (SAE) and adverse events of special interest (AESI);Presence of medically attended adverse events;Presence of unsolicited adverse events;Presence of solicited injection site reactions and systemic reactions;Presence of immediate adverse events | | | | Yes | False | | |
| → | NCT04799392 | 13 September 2021→8 November 2021 | NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons | NOWDx Test for the Detection of Antibodies to COVID-19 in Lay Persons | | NOWDiagnostics, Inc. | 14/03/2021 | 20210314 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04799392 | Recruiting→Not recruiting | No | 2 Years | N/A | All | April 1, 2021 | 339→50 | Interventional | Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | United States | ; → | Beth Cobb;Beth Cobb→Beth Cobb | | ;clinicaltrials@nowdx.com→ | ;479-966-4531→ | NOW Diagnostics, Inc.;→NOW Diagnostics, Inc. |
<br> Inclusion Criteria:
<br>
<br> Innate Infection Cohort>
<br>
<br> - PCR positives: persons who were symptomatic for COVID-19 and have tested positive for
<br> COVID-19 with an EUA or FDA cleared PCR test; 7+ days post positive PCR test
<br>
<br> - PCR negatives: persons who have never had COVID-19 and who have tested negative for
<br> COVID-19 with an EUA or FDA cleared PCR test; within 0-6 days post negative PCR test
<br>
<br> - persons 2+ years old
<br>
<br> Vaccination Cohort>
<br>
<br> - persons 7- 60 days post second dose of EUA COVID-19 vaccine
<br>
<br> - persons 18+ years old
<br>
<br> Exclusion criteria:
<br>
<br> Innate Infection Cohort>
<br>
<br> - PCR positives: persons with a COVID-19 positive test result >45 days old
<br>
<br> - PCR negatives: persons with any prior COVID-19 positive result
<br>
<br> - persons who have received COVID-19 vaccine
<br>
<br> - persons <2 years old
<br>
<br> Vaccination Cohort>
<br>
<br> - persons symptomatic or previously infected with COVID-19 prior to vaccination
<br>
<br> - persons <18 years old
<br> | | COVID-19;SARS-CoV-2;Coronavirus | Device: NOWDx COVID-19 Test | Positivity rate of NOWDx COVID-19 Tests in vaccinated persons;Percentage of clinical agreement between NOWDx COVID-19 Test and emergency use authorized or FDA cleared comparator | | | | Yes | False | | |
| → | NCT04813328 | 1 November 2021→8 November 2021 | The Effect of Helminth Infection Plus COVID-19 Infection on the Immune Response and Intestinal Microorganisms | A Pilot Study of the Effects of Helminth Infection and SARS-CoV-2 Seropositivity on Immune Response and the Intestinal Microbiota in India | | National Institute of Allergy and Infectious Diseases (NIAID) | 22/03/2021 | 20210322 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04813328 | Recruiting | No | 5 Years | N/A | All | June 1, 2021 | 600 | Observational | | | India | ; ; | Subash Babu, MBBS, PhD;P'ng Loke, PhD;Subash Babu, MBBS, PhD | | ;;sbabu@nirt.res.in | ;;044-28369711 | National Institute for Research in Tuberculosis;National Institutes of Health (NIH) |
<br> Inclusion Criteria:
<br>
<br> - Able to provide informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Poor venous access precluding venipuncture.
<br>
<br> - History of any illness or condition which, in the investigator's judgment, may
<br> substantially increase the risk associated with the participant's participation in the
<br> protocol, or compromise the scientific objectives.
<br>
<br> Participants may be co-enrolled in other studies; however study staff should be notified of
<br> co-enrollment.
<br> | | COVID-19 | | Number of participants with Trichuris infection;Number of participants with Strongyloides infection;Number of participants with hookworm infection;Number of participants with Ascaris infection;Number of participants with Strongyloides stercoralis infection;Number of participants with Wuchereria bancrofti infection;Number of participants with latent tuberculosis infection;Average Hematocrit levels;Average Differential blood count;Number of participants with positive malaria test;Number of participants with SARS-CoV-2 antibodies;Number of participants with helminth infections | | | | Yes | False | | |
| → | NCT04816669 | 11 October 2021→8 November 2021 | Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults→A Study to Evaluate Safety, Tolerability, & Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults | A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE | | BioNTech SE | 24/03/2021 | 20210324 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04816669 | Not recruiting | No | 18 Years | 55 Years | All | April 1, 2021 | 629 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | United States | | Pfizer CT.gov Call Center | | | | Pfizer |
<br> Inclusion Criteria:
<br>
<br> - Male or female participants 18 - 55 years of age, inclusive, at Visit 1, (Day 1).
<br>
<br> - Participants who are willing and able to comply with all scheduled visits, treatment
<br> plan, laboratory tests, lifestyle considerations, and other study procedures.
<br>
<br> - Healthy participants who are determined by medical history, physical examination (if
<br> required), and clinical judgment of the investigator to be eligible for inclusion in
<br> the study. Note: Healthy participants with pre-existing stable disease, defined as
<br> disease not requiring significant change in therapy or hospitalization for worsening
<br> disease during the 6 weeks before enrolment, can be included.
<br>
<br> - Capable of giving personal signed informed consent, which includes compliance with the
<br> requirements and restrictions listed in the ICD and in the protocol.
<br>
<br> Exclusion Criteria:
<br>
<br> - Other medical or psychiatric condition including recent (within the past year) or
<br> active suicidal ideation/behavior or laboratory abnormality that may increase the risk
<br> of study participation or, in the investigator's judgment, make the participant
<br> inappropriate for the study.
<br>
<br> - Known infection with HIV, HCV, or HBV.
<br>
<br> - History of severe adverse reaction associated with a vaccine and/or severe allergic
<br> reaction (eg, anaphylaxis) to any component of the study intervention(s).
<br>
<br> - Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result
<br> was not available) or microbiological (based on COVID-19 symptoms/signs and a positive
<br> SARS-CoV-2 NAAT result) diagnosis of COVID-19.
<br>
<br> - Immunocompromised individuals with known or suspected immunodeficiency, as determined
<br> by history and/or laboratory/physical examination.
<br>
<br> - Bleeding diathesis or condition associated with prolonged bleeding that would, in the
<br> opinion of the investigator, contraindicate intramuscular injection.
<br>
<br> - Women who are pregnant or breastfeeding.
<br>
<br> - Previous vaccination with any coronavirus vaccine.
<br>
<br> - Receipt of medications intended to prevent COVID-19.
<br>
<br> - Individuals who receive treatment with radiotherapy or immunosuppressive therapy,
<br> including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids
<br> are administered for =14 days at a dose of =20 mg/day of prednisone or equivalent),
<br> eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
<br> Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes)
<br> corticosteroids are permitted.
<br>
<br> - Receipt of blood/plasma products or immunoglobulin, from 60 days before study
<br> intervention administration or planned receipt throughout the study.
<br>
<br> - Participation in other studies involving study intervention within 28 days prior to
<br> study entry and/or during study participation / Previous participation in other
<br> studies involving study intervention containing lipid nanoparticles (LNPs).
<br>
<br> - Previous participation in other studies involving study intervention containing lipid
<br> nanoparticles.
<br>
<br> - Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct
<br> of the study, site staff otherwise supervised by the investigator, and their
<br> respective family members.
<br> →
<br> Inclusion Criteria:
<br>
<br> - Male or female participants 18 - 55 years of age, inclusive, at Visit 1, (Day 1).
<br>
<br> - Participants who are willing and able to comply with all scheduled visits, treatment
<br> plan, laboratory tests, lifestyle considerations, and other study procedures.
<br>
<br> - Healthy participants who are determined by medical history, physical examination (if
<br> required), and clinical judgment of the investigator to be eligible for inclusion in
<br> the study. Note: Healthy participants with pre-existing stable disease, defined as
<br> disease not requiring significant change in therapy or hospitalization for worsening
<br> disease during the 6 weeks before enrolment, can be included.
<br>
<br> - Capable of giving personal signed informed consent, which includes compliance with the
<br> requirements and restrictions listed in the ICD and in the protocol.
<br>
<br> - For Dose 3: Participants who received BOTH doses of the lyophilized formulation of
<br> BNT162b2 as part of the initial study.
<br>
<br> Exclusion Criteria:
<br>
<br> - Other medical or psychiatric condition including recent (within the past year) or
<br> active suicidal ideation/behavior or laboratory abnormality that may increase the risk
<br> of study participation or, in the investigator's judgment, make the participant
<br> inappropriate for the study.
<br>
<br> - Known infection with HIV, HCV, or HBV.
<br>
<br> - History of severe adverse reaction associated with a vaccine and/or severe allergic
<br> reaction (eg, anaphylaxis) to any component of the study intervention(s).
<br>
<br> - Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result
<br> was not available) or microbiological (based on COVID-19 symptoms/signs and a positive
<br> SARS-CoV-2 NAAT result) diagnosis of COVID-19.
<br>
<br> - Immunocompromised individuals with known or suspected immunodeficiency, as determined
<br> by history and/or laboratory/physical examination.
<br>
<br> - Bleeding diathesis or condition associated with prolonged bleeding that would, in the
<br> opinion of the investigator, contraindicate intramuscular injection.
<br>
<br> - Women who are pregnant or breastfeeding.
<br>
<br> - Previous vaccination with any coronavirus vaccine.
<br>
<br> - Receipt of medications intended to prevent COVID-19.
<br>
<br> - Individuals who receive treatment with radiotherapy or immunosuppressive therapy,
<br> including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids
<br> are administered for =14 days at a dose of =20 mg/day of prednisone or equivalent),
<br> eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
<br> Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes)
<br> corticosteroids are permitted.
<br>
<br> - Receipt of blood/plasma products or immunoglobulin, from 60 days before study
<br> intervention administration or planned receipt throughout the study.
<br>
<br> - Participation in other studies involving study intervention within 28 days prior to
<br> study entry and/or during study participation / Previous participation in other
<br> studies involving study intervention containing lipid nanoparticles (LNPs).
<br>
<br> - Previous participation in other studies involving study intervention containing lipid
<br> nanoparticles.
<br>
<br> - Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct
<br> of the study, site staff otherwise supervised by the investigator, and their
<br> respective family members.
<br> | | SARS-CoV-2 Infection;COVID-19 | Biological: BNT162b2 | Geometric mean ratio of lyophilized BNT162b2 in single-dose vials is noninferior to frozen-liquid BNT162b2 in multi-dose vials in participants without evidence of SARS-CoV-2 infection;Percentage of participants reporting local reactions;Percentage of participants reporting systemic events;Percentage of participants reporting adverse events;Percentage of participants reporting serious adverse events→Percentage of participants reporting serious adverse events;Percentage of participants reporting adverse events;Percentage of participants reporting systemic events;Percentage of participants reporting local reactions;Geometric mean ratio of lyophilized BNT162b2 in single-dose vials is noninferior to frozen-liquid BNT162b2 in multi-dose vials in participants without evidence of SARS-CoV-2 infection | | | | Yes | False | | |
| → | NCT04828161 | 1 November 2021→8 November 2021 | A Dose Finding, Efficacy and Safety Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 | A Randomized, Double-blind, Placebo-controlled, Multicenter Study of Ensovibep (MP0420) in Ambulatory Adult Patients With Symptomatic COVID-19 - The "EMPATHY" Trial | EMPATHY | Molecular Partners AG | 24/03/2021 | 20210324 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04828161 | Recruiting | No | 18 Years | N/A | All | May 24, 2021 | 2100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States;South Africa;Poland;Netherlands;India;Hungary;South Africa;Poland;Netherlands;India;Hungary;United States | ; | Medical Director MPAG;King G Hospital | | info@molecularpartners.com; | +41 44 755 7700; | |
<br> Inclusion Criteria:
<br>
<br> 1. Men or women = 18 years of age on the day of inclusion (no upper limit).
<br>
<br> 2. Presence of two or more COVID-19 symptoms and onset within 7 days prior to dosing:
<br> Feeling hot or feverish, cough, sore throat, low energy or tiredness, headache, muscle
<br> or body aches, chills or shivering, and shortness of breath.
<br>
<br> 3. Positive test for SARS-CoV-2 in upper respiratory swab on the day of dosing (rapid
<br> antigen test).
<br>
<br> 4. Understand and agree to comply with the planned study procedures.
<br>
<br> 5. The patient or legally authorized representative give signed informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Requiring hospitalization at time of screening, or at time of study drug
<br> administration.
<br>
<br> 2. Oxygen saturation (SpO2) = 93% on room air at sea level or ratio of arterial oxygen
<br> partial pressure (PaO2 in mmHg) to fractional inspired oxygen (FiO2) < 300,
<br> respiratory rate = 30 per minute, and heart rate = 125 per minute.
<br>
<br> 3. Known allergies to any of the components used in the formulation of the ensovibep or
<br> placebo.
<br>
<br> 4. Suspected or proven serious, active bacterial, fungal, viral, or other infection
<br> (besides SARS-CoV-2) that in the opinion of the investigator could constitute a risk
<br> when taking intervention.
<br>
<br> 5. Any serious concomitant systemic disease, condition, or disorder that, in the opinion
<br> of the investigator, should preclude participation in this study.
<br>
<br> 6. Any co-morbidity requiring surgery within 7 days of dosing, or that is considered
<br> life-threatening within 29 days of dosing.
<br>
<br> 7. Prior or concurrent use of any medication for treatment of COVID-19, including
<br> antiviral agents, convalescent serum, or anti-viral antibodies. Purely symptomatic
<br> therapies (e.g., over-the-counter [OTC] cough medications, acetaminophen, and
<br> nonsteroidal anti-inflammatories [NSAIDs]) are permitted. Prior vaccination for
<br> COVID-19 is permitted.
<br> | | COVID-19 | Drug: ensovibep;Drug: Placebo | Part A - SARS-CoV-2 viral load;Part B - Occurrence of hospitalizations, emergency room visits or death→Part B - Occurrence of hospitalizations, emergency room visits or death;Part A - SARS-CoV-2 viral load | | | | Yes | False | | |
| → | NCT04852978 | 1 November 2021→8 November 2021 | COVID-19 Study to Assess Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers | A Phase 2 Randomized, Open-Label, Parallel Group Study to Assess the Immunogenicity, Safety, and Tolerability of Moderna mRNA-1273 Vaccine Administered With Casirivimab+Imdevimab in Healthy Adult Volunteers | | Regeneron Pharmaceuticals | 19/04/2021 | 20210419 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04852978 | Recruiting | No | 18 Years | 90 Years | All | April 29, 2021 | 286 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | ; | Clinical Trial Management;Clinical Trials Administrator | | ;clinicaltrials@regeneron.com | ;844-734-6643 | Regeneron Pharmaceuticals; |
<br> Key Inclusion Criteria:
<br>
<br> 1. Healthy or has chronic medical condition(s) that are stable and well-controlled in the
<br> opinion of the investigator and that are not likely to require significant medical
<br> intervention through the end of study
<br>
<br> 2. Willing and able to comply with study visits and study-related procedures, including
<br> compliance with site precautionary requirements related to SARS-CoV-2 infection and
<br> transmission
<br>
<br> Key Exclusion Criteria:
<br>
<br> 1. Positive RT-PCR test result for SARS-CoV-2 infection at screening or baseline
<br>
<br> 2. Positive serology test result for anti-SARS-CoV-2 antibodies at screening or baseline
<br>
<br> 3. COVID-19 diagnosis, positive SARS-CoV-2 infection, or positive SARS-CoV-2 serology at
<br> any time prior to screening
<br>
<br> 4. Previously received an investigational, authorized, or approved coronavirus vaccine
<br> (eg, SARS-CoV-2 vaccine, MERS-CoV vaccine)
<br>
<br> 5. Currently enrolled in, or has plans to enroll in, any interventional study to prevent
<br> or treat COVID-19
<br>
<br> 6. Received investigational or approved passive antibodies for SARS-CoV-2 infection
<br> prophylaxis ad defined in the protocol
<br>
<br> 7. Received intravenous immunoglobulin (IVIG) or blood products in the last 3 months
<br>
<br> 8. Any physical examination findings and/or history of any illness that, in the opinion
<br> of the study investigator, might confound the results of the study or pose an
<br> additional risk to the subject by study participation
<br>
<br> 9. History of clinically significant cardiovascular, respiratory, hepatic, renal,
<br> gastrointestinal, endocrine, hematological, psychiatric or neurological disease, as
<br> assessed by the investigator, that may confound the results of the study or pose an
<br> additional risk to the subject by study participation
<br>
<br> 10. Medically attended acute illness or hospitalization (ie, >24 hours) for any reason
<br> within 30 days prior to screening
<br>
<br> 11. Clinical history of myocarditis and/or pericarditis
<br>
<br> Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
<br> | | Healthy;Chronic Stable Illness | Drug: REGN10933+REGN10987;Biological: Moderna mRNA-1273 vaccine→Drug: casirivimab+imdevimab;Biological: Moderna mRNA-1273 vaccine | 50% inhibitory dilution (ID50) titers of vaccine-induced neutralizing antibodies to the SARS-CoV-2 S protein;50% inhibitory dilution (ID50) titers of vaccine-induced neutralizing antibodies to the SARS-CoV-2 S protein | | | | Yes | False | | |
| → | NCT04858568 | 1 November 2021→8 November 2021 | Immune Responses to COVID-19 Vaccination in Lymphoma Patients | PROSECO - A UK Multicentre Prospective Observational Study Evaluating COVID-19 Vaccine Immune Responses in Lymphoid Cancer | PROSECO | University Hospital Southampton NHS Foundation Trust | 22/04/2021 | 20210422 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04858568 | Not recruiting | No | 18 Years | N/A | All | March 11, 2021 | 592 | Observational | | | United Kingdom | | | | | | |
<br> INCLUSION CRITERIA
<br>
<br> 1. Patients having a confirmed diagnosis of either:
<br>
<br> A) Hodgkin lymphoma B) Aggressive B-cell lymphoma (e.g. Burkitt's lymphoma, diffuse
<br> large B-cell lymphoma, grade 3b follicular lymphoma, de novo transformed follicular
<br> lymphoma) C) Indolent B-cell lymphoma (e.g. all grades of follicular lymphoma except
<br> grade 3b, marginal zone lymphoma, lymphoplasmacytic lymphoma, chronic or small
<br> lymphocytic lymphoma, mantle cell lymphoma) D) Mature T/NK-cell malignancy (any
<br> subtype)
<br>
<br> 2. Patient must be = 18 years.
<br>
<br> 3. Patients will have provided written Informed Consent.
<br>
<br> EXCLUSION CRITERIA
<br>
<br> 1) Serious medical or psychiatric illness likely to affect participation or that may
<br> compromise the ability to give informed consent.
<br> | | Classical Hodgkin Lymphoma;Diffuse Large B Cell Lymphoma;Primary Mediastinal B Cell Lymphoma;High-grade B-cell Lymphoma;Burkitt Lymphoma;Follicular Lymphoma;Mantle Cell Lymphoma;Marginal Zone Lymphoma;Chronic Lymphocytic Leukemia;Small Lymphocytic Lymphoma;Lymphoplasmacytic Lymphoma;Nodular Lymphocyte Predominant Hodgkin Lymphoma;Peripheral T-cell Lymphoma | | Serum IgG levels against SARS-CoV-2 post-COVID-19 vaccination and change over time. | | | | Yes | False | | |
| → | NCT04859517 | 1 November 2021→8 November 2021 | Evaluation of ADG20 for the Prevention of COVID-19 | A Phase 2/3 Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Prevention of COVID 19 (EVADE) | EVADE | Adagio Therapeutics, Inc. | 21/04/2021 | 20210421 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04859517 | Recruiting | Yes | 12 Years | N/A | All | April 23, 2021 | 6412 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States;Czechia;Georgia;Moldova, Republic of;Poland;Romania;Ukraine;Czechia;Georgia;Moldova, Republic of;Poland;Romania;Ukraine;United States | | Study Inquiry | | ClinicalTrials@adagiotx.com | +1 781-819-0080 | |
<br> Inclusion Criteria:
<br>
<br> - Tests negative for current or previous SARS-CoV-2 infection by RT PCR and serology
<br> (Pre-exposure population only)
<br>
<br> - Is at high risk of SARS-CoV-2 infection as assessed by the Investigator:
<br>
<br> 1. Post-exposure population: including, but not limited, to household contact or
<br> occupational/recreational exposure to an individual with a diagnosis of
<br> SARS-CoV-2 infection (index case). Note: Participants with recent exposure to a
<br> laboratory-confirmed index case must be asymptomatic and randomized within 5 days
<br> (120 hours) of collection of the index case's positive SARS-CoV-2 diagnostic
<br> test.
<br>
<br> 2. Pre-exposure population: Occupational, housing, recreational and/or social
<br> conditions that are likely to increase risk of exposure to SARS-CoV-2.
<br>
<br> - Agrees to defer receipt of COVID-19 vaccination for minimum of 180 days (6 months)
<br> after dosing
<br>
<br> Exclusion Criteria:
<br>
<br> - Has received (1) a SARS-CoV-2 vaccine, (2) mAb or (3) convalescent plasma from a
<br> person who has recovered from COVID-19 or prior participation in SARS-CoV2 vaccine,
<br> convalescent plasma, or mAb clinical trial any time prior to participation in the
<br> study.
<br>
<br> - Receipt of any investigational product within 30 days or 5 half lives before the day
<br> of enrollment.
<br>
<br> - Is acutely ill or febrile 72 hours before or at Screening or has other COVID-19
<br> symptoms including cough, fatigue, muscle or body aches, headache, or loss of taste or
<br> smell. Fever is defined as a body temperature =38.0°C (=100.4°F).
<br>
<br> - Has received or plans to receive a non-COVID-19 vaccine within 28 days before or after
<br> dosing (except for seasonal influenza vaccine, which is not permitted within 14 days
<br> before or after dosing).
<br>
<br> NOTE: Other protocol defined inclusion/exclusion criteria apply
<br> | | COVID-19 | Drug: ADG20;Drug: Placebo | Proportion of participants with RT-PCR confirmed symptomatic COVID-19;Proportion of participants with RT-PCR confirmed symptomatic COVID-19;Incidence of solicited injection site reactions;Incidence of treatment emergent adverse events | | | | Yes | True | parent | |
| → | NCT04864561 | 1 November 2021→8 November 2021 | Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine | A Randomized, Observer-Blind, Controlled, Superiority Study To Compare The Immunogenicity Against COVID-19, Of VLA2001 Vaccine To AZD1222 Vaccine, In Adults Including a Randomized, Observer-blind, Placebo Controlled Part in Adolescents (=12 to <18 Years) | COV-COMPARE | Valneva Austria GmbH | 23/04/2021 | 20210423 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04864561 | Recruiting | No | 12 Years | N/A | All | April 26, 2021 | 4679 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor). | Phase 3 | United Kingdom | ; | Valneva Clinical Development;Valneva Clinical Development | | ;office@valneva.com | ;+43 1 206 20 | Valneva Austria GmbH; |
<br> Inclusion Criteria:
<br>
<br> 1. Participants must have read, understood, and signed the informed consent form (ICF).
<br>
<br> 2. Participants of either gender aged 12 years and older at screening.
<br>
<br> 3. Medically stable
<br>
<br> 4. Must be able to attend all visits of the study and comply with all study procedures,
<br>
<br> 5. Women of childbearing potential (WOCBP) must be able and willing to use at least 1
<br> highly effective method of contraception for a minimum of 3 months after the last dose
<br> of study vaccine.
<br>
<br> 6. WOCBPs must have a negative pregnancy test prior to each vaccination.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Participant is pregnant or planning to become pregnant within 3 months after study
<br> vaccine administration.
<br>
<br> 2. History of allergy to any component of the vaccine.
<br>
<br> 3. Significant infection (e.g. positive SARS-CoV-2 RT-PCR) or other acute illness,
<br> including fever > 100 °F (> 37.8 °C) 48 hours before vaccination.
<br>
<br> 4. Participant has a known or suspected defect of the immune system
<br>
<br> 5. Participant has a history of cerebral venous sinus thrombosis, heparin-induced
<br> thrombocytopenia or antiphospholipid syndrome.
<br>
<br> 6. Participant has a history of malignancy in the past 5 years other than squamous cell
<br> or basal cell skin cancer. If there has been surgical excision or treatment more than
<br> 5 years ago that is considered to have achieved a cure, the participant may be
<br> enrolled. A history of hematologic malignancy is a permanent exclusion. Participants
<br> with a history of skin cancer must not be vaccinated at the previous tumour site.
<br>
<br> 7. History of drug dependency or current use of drug of abuse or alcohol abuse at
<br> screening.
<br>
<br> 8. Significant blood loss (> 450 mL) or has donated 1 or more units of blood or plasma
<br> within 6 weeks prior to the expected day of randomization (Visit 1).
<br>
<br> 9. History of clinically significant bleeding disorder, or prior history of significant
<br> bleeding or bruising following IM injections or venepuncture.
<br>
<br> 10. Severe and uncontrolled ongoing autoimmune or inflammatory disease History of
<br> Guillain-Barre syndrome or any other demyelinating condition.
<br>
<br> 11. Any other significant disease, disorder or finding which in the opinion of the
<br> investigator may significantly increase the risk to the volunteer
<br>
<br> Prior/concomitant therapy:
<br>
<br> 12. Receipt of immunoglobulin or another blood product within the 3 months before expected
<br> day of randomization (visit 1) in this study or those who expect to receive
<br> immunoglobulin or another blood product during this study.
<br>
<br> 13. Receipt of medications and or vaccinations intended to prevent COVID-19.
<br>
<br> 14. Receipt of any vaccine (licensed or investigational), other than licensed influenza
<br> vaccine, within 28 days prior to the expected day of randomization (Visit 1).
<br>
<br> 15. Any member of the study team or sponsor.
<br>
<br> 16. An immediate family member or household member of the study's personnel.
<br>
<br> Booster Vaccination (Adolescents)
<br>
<br> In addition to the above described eligibility criteria, the following criteria must be
<br> met:
<br>
<br> - Participant has completed the primary vaccination schedule per protocol (i.e. has
<br> received 2 study vaccinations within protocol windows).
<br> | | SARS-CoV-2 Virus Infection | Biological: VLA2001;Biological: AZD1222;Biological: VLA2001 - adolescent part;Biological: Placebo | Frequency and severity of any Adverse Events (AE);Immune response measured after completion of a 2-dose immunization schedule, as determined by Seroconversion (definded as 4-fold increase from baseline) of SARS-CoV-2-specific neutralizing antibodies;Immune response measured after completion of a 2-dose immunization schedule, as determined by the geometric mean titer (GMT) of SARS-CoV-2-specific neutralizing antibodies | | | | Yes | False | | |
| → | NCT04870606 | 1 November 2021→8 November 2021 | Proxalutamide (GT0918) Treatment for Outpatients With Mild or Moderate COVID-19 Illness | A Randomized, Double-blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Outpatients With Mild to Moderate COVID-19 Illness | | Suzhou Kintor Pharmaceutical Inc, | 27/04/2021 | 20210427 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04870606 | Recruiting | No | 18 Years | N/A | All | March 5, 2021 | 668 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | United States | | Clinical operation | | kintor.co@kintor.com.cn | 0512-62639909→86-512-62639909 | |
<br> Inclusion Criteria:
<br>
<br> 1. The subject or legally authorized representative give signed informed consent which
<br> includes compliance with the requirements and restrictions listed in the ICF and in
<br> this protocol.
<br>
<br> 2. Understand and agree to comply with planned study procedures.
<br>
<br> 3. Male subjects with age =18 years of age at the time of randomization.
<br>
<br> 4. Are currently not hospitalized.
<br>
<br> 5. Have one or more mild or moderate symptom(s) COVID-19-related symptoms within 5 days
<br> of onset of symptoms onset
<br>
<br> 6. Must have first positive SARS-CoV-2 viral infection determination (has
<br> laboratory-confirmed SARS-CoV-2 infection as determined by PCR, or other commercial or
<br> public health assay in any specimen) =3 days prior to start of the first dose.
<br>
<br> 7. Regardless of their fertility status, male subjects must agree to either remain
<br> abstinent (if this is their preferred and usual lifestyle) or use condoms as well as
<br> one additional highly effective method of contraception (less than 1% failure rate) or
<br> effective method of contraception with nonpregnant women of childbearing potential
<br> partners for the duration of the study and until 90 days after the last dose.
<br>
<br> Use an acceptable method of contraception such as:
<br>
<br> - Highly effective methods of contraception (less than 1% failure rate) comprise,
<br> but are not limited to
<br>
<br> - combination oral contraceptives
<br>
<br> - implanted contraceptives, or
<br>
<br> - intrauterine devices.
<br>
<br> - Effective methods of contraception comprise but are not limited to
<br>
<br> - diaphragms with spermicide or cervical sponges.
<br>
<br> - men and their partners may choose to use a double-barrier method of
<br> contraception that must include use of a spermicide.
<br>
<br> 8. Agree to the collection of nasopharyngeal swabs and venous blood.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Have SpO2 = 93% on room air at sea level or PaO2/FiO2 < 300, respiratory rate =30 per
<br> minute, heart rate =125 per minute
<br>
<br> 2. Estimated glomerular filtration rate (eGFR) < 30 ml/min
<br>
<br> 3. Serum total bilirubin > 1.5 x ULN (upper limit of normal) and AST and ALT >3x ULN
<br>
<br> 4. Subjects with significant cardiovascular disease as following:
<br>
<br> i. heart failure NYHA class =3 ii. left ventricular ejection fraction <50% iii. those
<br> with a history of cardiac arrhythmias, including long QT syndrome.
<br>
<br> 5. Has been admitted to a hospital prior to randomization, or is hospitalized (inpatient)
<br> at randomization, due to COVID-19 or requires treatment with supplemental oxygen.
<br>
<br> 6. Have known allergies to any of the components used in the formulation of the
<br> interventions.
<br>
<br> 7. Have hemodynamic instability requiring use of vasopressors within 24 hours of
<br> randomization.
<br>
<br> 8. Suspected or proven serious, active bacterial, fungal, viral, or other infection
<br> (except COVID-19) that in the opinion of the investigator could constitute a risk when
<br> taking intervention (i.e. known history of human immunodeficiency virus [HIV]).
<br>
<br> 9. Have any co-morbidity requiring surgery within <7 days, or that is considered
<br> life-threatening within 30 days.
<br>
<br> 10. Have any serious concomitant systemic disease, condition, or disorder that, in the
<br> opinion of the investigator, should preclude participation in this study.
<br> | | Efficacy and Safety | Drug: Proxalutamide (GT0918);Drug: Placebo | Efficacy of Proxalutamide | | | | Yes | False | | |
| → | NCT04885530 | 7 September 2021→8 November 2021 | ACTIV-6: COVID-19 Study of Repurposed Medications | ACTIV-6: COVID-19 Outpatient Randomized Trial to Evaluate Efficacy of Repurposed Medications | | Susanna Naggie, MD | 30/04/2021 | 20210430 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04885530 | Recruiting | No | 30 Years | N/A | All | June 8, 2021 | 15000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider). | Phase 3 | United States | ; | Susanna Naggie, MD;Sybil Wilson | | ;sybil.wilson@duke.edu | ;1-833-385-1880 | Duke Clinical Research Institute; |
<br> Inclusion Criteria:
<br>
<br> - Completed Informed Consent
<br>
<br> - Age = 30 years old
<br>
<br> - Confirmed SARS-CoV-2 infection by any authorized or approved polymerase chain reaction
<br> (PCR) or antigen test collected within 10 days of screening
<br>
<br> - Two or more current symptoms of acute infection for =7 days. Symptoms include the
<br> following: fatigue, dyspnea, fever, cough, nausea, vomiting, diarrhea, body aches,
<br> chills, headache, sore throat, nasal symptoms, new loss of sense of taste or smell
<br>
<br> Exclusion Criteria:
<br>
<br> - Prior diagnosis of COVID-19 infection (> 10 days from screening)
<br>
<br> - Current or recent (within 10 days of screening) hospitalization
<br>
<br> - Known allergy/sensitivity or any hypersensitivity to components of the study drug or
<br> placebo
<br>
<br> - Known contraindication(s) to study drug including prohibited concomitant medications
<br> | | Covid19 | Drug: Ivermectin;Drug: Fluvoxamine;Drug: Fluticasone;Other: Placebo | Number of symptoms as measured by patient reports;Number of deaths as measured by patient reports;Number of hospitalizations as measured by patient reports. | | | | Yes | False | | |
| → | NCT04894266 | 7 June 2021→8 November 2021 | An Open-Label Study of Apabetalone in Covid Infection | An Open-Label Study to Assess the Safety and Effect on Clinical Course and Key Biomarkers of Oral Apabetalone in Hospitalized Subjects With Covid-19 Infection in Addition to Standard of Care (SOC) | | Resverlogix Corp | 05/05/2021 | 20210505 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04894266 | Not recruiting→Recruiting | No | 18 Years | N/A | All | June 12, 2021→November 1, 2021 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2/Phase 3 | United States→United States;Canada | → ; | Mike Sweeney, MD→Mike Sweeney, MD;Wendy Sligl, MD | | msweeney@reseverlogix.com→msweeney@reseverlogix.com;wsligl@ualberta.ca | 415 4705613→415 4705613;(780) 492-8311 | |
<br> Inclusion Criteria:
<br>
<br> 1. Provide informed consent before participation in the study.
<br>
<br> 2. Aged =18 years
<br>
<br> 3. Hospital admission with symptoms suggestive of COVID-19 infection
<br>
<br> 4. Ten days or less since the onset of symptoms
<br>
<br> 5. Virological confirmation of SARS-CoV2 infection by reverse transcriptase PCR (RT- PCR)
<br> according to Center for Disease Control and Prevention (CDC) guidelines within the
<br> previous 72 hours
<br>
<br> 6. Subjects showing bilateral pulmonary infiltrates on chest imaging
<br>
<br> 7. Saturation of oxygen (SpO2) by pulse oximetry <94% on room air at sea level.
<br>
<br> 8. Female subjects must meet one of the following:
<br>
<br> - If of childbearing potential, female subjects must have a negative urine
<br> pregnancy test at screening and must also be willing to practice total abstinence
<br> or to use an approved (non-hormonal) form of birth-control throughout the study
<br> treatment phase and up to 28 days after the last study drug dose if randomized to
<br> apabetalone." -OR-
<br>
<br> - Meet at least one of the following criteria:
<br>
<br> - Be postmenopausal, defined as having been amenorrheic for at least 2 years
<br>
<br> - Have had a hysterectomy or a bilateral oophorectomy
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subjects with SpO2 >94% on room air using pulse oximetry and without bilateral
<br> infiltrates on chest imaging
<br>
<br> 2. Subjects requiring mechanical ventilation or extracorporeal membrane oxygenation
<br>
<br> 3. Patients with Stage 5 CKD receiving renal replacement therapy with either hemodialysis
<br> or peritoneal dialysis, renal transplant or with eGFR <15 mL/min/1.73 m2.
<br>
<br> 4. Patients with prior transplantations of organs or bone marrow.
<br>
<br> 5. Patients with unstable cardiac condition including heart attack, stroke, uncontrolled
<br> atrial fibrillation or a major cardiac procedure within 3 months as assessed by the
<br> investigator.
<br>
<br> 6. New York Heart Association Class IV congestive heart failure.
<br>
<br> 7. Evidence of cirrhosis from liver imaging or biopsy, a history of hepatic
<br> encephalopathy, esophageal or gastric varices, active hepatitis, or prior porta-caval
<br> shunt procedure.
<br>
<br> 8. ALT or AST >5 x ULN on admission laboratory assessment.
<br>
<br> 9. Total bilirubin >2 x ULN on admission laboratory assessment.
<br>
<br> 10. Have received any live attenuated vaccine within 90 days at dosing.
<br>
<br> 11. Known human immunodeficiency virus positive patients.
<br>
<br> 12. Chronic use of oxygen therapy at home
<br>
<br> 13. Have participated in a clinical study and received any investigational medication
<br> within the last 30 days preceding Visit 1 (Screening).
<br>
<br> 14. Subjects whose safety may be compromised by study participation
<br>
<br> 15. Are not, in the opinion of the investigator, able or willing to comply with the
<br> protocol.
<br> | | COVID-19 Infection | Drug: Apabetalone;Other: Standard of care | The primary endpoint of the study is the change in WHO Ordinal Scale for Clinical Improvement at Day 14 | | | | Yes | False | | |
| → | NCT04894305 | 1 November 2021→8 November 2021 | A Study of Ad26.COV2.S in Healthy Adults (COVID-19) | A Phase 1, Randomized, Observer-blind Study to Compare the Safety, Reactogenicity, and Immunogenicity of Ad26.COV2.S at a Single Dose of 5*10^10 vp in 2 Different Volumes in Healthy Adults | | Janssen Vaccines & Prevention B.V. | 18/05/2021 | 20210518 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04894305 | Not recruiting | No | 18 Years | 65 Years | All | May 25, 2021 | 380 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 1 | Netherlands | | Janssen Vaccines & Prevention B.V. Clinical Trial | | | | Janssen Vaccines & Prevention B.V. |
<br> Inclusion Criteria:
<br>
<br> - Participant must sign an informed consent form (ICF) indicating that he or she
<br> understands the purpose, procedures and potential risks and benefits of the study, and
<br> is willing to participate in the study
<br>
<br> - Participant must be healthy, in the investigator's clinical judgment, as confirmed by
<br> medical history, physical examination, and vital signs performed at screening.
<br> Participant may have underlying illnesses, as long as the symptoms and signs are
<br> medically controlled and not considered to be comorbidities related to an increased
<br> risk of severe coronavirus disease-2019 (COVID-19), except for smoking, which is
<br> allowed. If on medication for a condition, the medication dose must have been stable
<br> for at least 12 weeks preceding vaccination and expected to remain stable for the
<br> duration of the study
<br>
<br> - All participants of childbearing potential must: a) have a negative highly sensitive
<br> urine pregnancy test at screening; b) have a negative highly sensitive urine pregnancy
<br> test immediately on the day of and prior to study vaccine administration
<br>
<br> - Participant agrees to not donate bone marrow, blood, and blood products from the first
<br> study vaccine administration until 3 months after receiving the study vaccine
<br>
<br> - Participant must be willing to provide verifiable identification, has means to be
<br> contacted and to contact the investigator during the study
<br>
<br> Exclusion Criteria:
<br>
<br> - Participant has a history of malignancy within 5 years before screening (exceptions
<br> are squamous and basal cell carcinomas of the skin and carcinoma in situ of the
<br> cervix, or malignancy, which is considered cured with minimal risk of recurrence)
<br>
<br> - Participant has a known or suspected allergy or history of anaphylaxis or other
<br> serious adverse reactions to vaccines or their excipients (including specifically the
<br> excipients of the study vaccine)
<br>
<br> - Participant has a history of any neurological disorders or seizures including
<br> Guillain-barre syndrome, with the exception of febrile seizures during childhood
<br>
<br> - Participant has a history of chronic urticaria (recurrent hives), eczema or adult
<br> atopic dermatitis
<br>
<br> - Participant received treatment with immunoglobulins in the 3 months or exogenous blood
<br> products (autologous blood transfusions are not exclusionary) in the 4 months before
<br> the planned administration of the study vaccine or has any plans to receive such
<br> treatment during the study
<br>
<br> - Upper limit of body mass index (BMI) range should not be considered in participants
<br> with comorbidities that are or might be associated with an increased risk of
<br> progression to severe COVID-19. Participants may have hypertension of mild severity,
<br> as long as it is stable and medically controlled as defined by no change in medication
<br> over the past 6 months (except for issues of tolerability or use of similar drug with
<br> same mechanism of action, example, thiazides, beta blockers, alpha blockers at the
<br> same effective dose)
<br>
<br> - Participant who is an employee of the sponsor, investigator or study site with direct
<br> involvement in the proposed study or other studies under the direction of that
<br> investigator or study site, including the family members of those employees or the
<br> investigator
<br> | | Healthy | Biological: Ad26.COV2.S | S Enzyme-linked Immunosorbent Assay (S-ELISA) Geometric Mean Concentrations (GMCs) 28 Days After Vaccination;Number of Participants with Adverse Events of Special Interests (AESIs);Number of Participants with Serious Adverse Events (SAEs);Number of Participants with AEs Leading to Study Discontinuation;Number of Participants with Unsolicited AEs for 28 Days After Vaccination;Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination;Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination→Number of Participants with Solicited Local Adverse Events (AEs) for 7 Days After Vaccination;Number of Participants with Solicited Systemic AEs for 7 Days After Vaccination;Number of Participants with Unsolicited AEs for 28 Days After Vaccination;Number of Participants with AEs Leading to Study Discontinuation;Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Adverse Events of Special Interests (AESIs);S Enzyme-linked Immunosorbent Assay (S-ELISA) Geometric Mean Concentrations (GMCs) 28 Days After Vaccination | | | | Yes | False | | |
| → | NCT04896840 | 7 September 2021→8 November 2021 | Tele-rehabilitation in Children With Cerebral Palsy in the Covid-19 Pandemic | The Effect of Motor Learning Based Tele-rehabilitation on Quality of Life in Children With Cerebral Palsy During the Covid-19 Epidemic Process | | Inonu University | 14/05/2021 | 20210514 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04896840 | Recruiting | No | 3 Years | 16 Years | All | August 27, 2021 | 30 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Turkey | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Children with spastic cerebral palsy, ages 3-16
<br>
<br> - To be at 1-2-3 levels according to GMFCS
<br>
<br> - The tele-rehabilitation group is not receiving treatment in any center.
<br>
<br> - Voluntary participation in the study with the consent of the parents
<br>
<br> Exclusion Criteria:
<br>
<br> - Application of muscle tone reduction 6 months before the start of the study (eg
<br> botulin toxin, baclofen pump therapy) or those undergoing orthopedic surgery.
<br> | | Cerebral Palsy;Telerehabilitation;Motor Learning | Other: Telerehabilitation Intervention, Motor learning | Pediatric Quality of Life Inventory | | | | Yes | False | | |
| → | NCT04901689 | 1 November 2021→8 November 2021 | Leronlimab in Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation | A Phase 3, Randomized, Double Blind, Placebo Controlled Trial to Evaluate the Efficacy and Safety of Leronlimab in Combination With Standard of Care for Patients With Coronavirus Disease 2019 (COVID-19) With Need for Mechanical Ventilation or Extracorporeal Membrane Oxygenation | | Hospital Israelita Albert Einstein | 24/05/2021 | 20210524 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04901689 | Recruiting | No | 18 Years | N/A | All | October 23, 2021 | 316 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | Brazil | | Otavio Berwanger, MD, PhD | | otavio.berwanger@einstein.br | +551121515915 | |
<br> Inclusion Criteria:
<br>
<br> 1. Male or females aged = 18 years
<br>
<br> 2. Critically ill patients with COVID-19 (defined as Ordinal Scale score of 7):
<br> Hospitalized, on invasive mechanical ventilation or extracorporeal membrane
<br> oxygenation (ECMO) for less than 72 hours.
<br>
<br> 3. Evidence of pneumonia (pulmonary infiltrates) at chest radiography or computed
<br> tomography compatible with COVID-19.
<br>
<br> 4. Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection as determined by
<br> polymerase chain reaction (PCR).
<br>
<br> 5. Subject (or legally authorized representative) provides written or oral informed
<br> consent prior to initiation of any study procedures.
<br>
<br> 6. Women of childbearing potential and their partner must agree to use at least one
<br> highly effective method of contraception (e.g., hormonal contraceptives [implants,
<br> injectables, combination oral contraceptives, transdermal patches, or contraceptive
<br> rings], intrauterine devices, bilateral tubal occlusion, or sexual abstinence) for the
<br> duration of the study.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subjects who had been on invasive mechanical ventilation or extracorporeal membrane
<br> oxygenation (ECMO) for >72 hours prior to the screening.
<br>
<br> 2. Subjects who have a history of allergic reactions attributed to compounds of similar
<br> chemical or biologic composition to leronlimab (PRO 140) are not eligible.
<br>
<br> 3. Inability to provide informed consent (from subject or legally authorized
<br> representative) or to comply with test requirements.
<br>
<br> 4. Other medical or psychiatric condition including recent (within the past year) or
<br> active suicidal ideation/behavior or laboratory abnormality that may increase the risk
<br> associated with study participation or, in the investigator's judgment, make the
<br> participant inappropriate for the study.
<br>
<br> 5. Pregnancy or breast feeding.
<br>
<br> 6. Subject participating in another study with for an investigational treatment.
<br>
<br> 7. Suspected or known active systemic bacterial, fungal, or viral infections (with the
<br> exception of COVID-19), that may increase the risk for the study participant based on
<br> investigator judgement.
<br>
<br> 8. Participants who are immunocompromised, with known immunodeficiencies, or taking
<br> potent immunosuppressive agents (e.g., azathioprine, cyclosporine).
<br>
<br> 9. Patients with estimated discharge or transfer for other hospital in the first 72 hours
<br> of study inclusion.
<br>
<br> 10. Patients with low probability of survival in the first 48 hours of study inclusion.
<br> | | COVID-19 Pneumonia | Drug: Leronlimab;Drug: Placebo | Cumulative proportion of clinical recovery | | | | Yes | False | | |
| → | NCT04904692 | 7 June 2021→8 November 2021 | Virological and Immunological Monitoring in Patients (Suspected of/Confirmed With) COVID-19 | Virological and Immunological Monitoring in Patients (Suspected of/Confirmed With) COVID-19 | Co-Vim | University Hospital, Ghent | 28/05/2020 | 20200528 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04904692 | Not recruiting | No | 18 Years | N/A | All | March 23, 2020 | 109 | Observational | | | Belgium | | Linos Vandekerckhove, Prof. MD | | | | University Hospital, Ghent |
<br> Inclusion Criteria:
<br>
<br> - Upper or lower respiratory symptoms and temperature =37.5°C, with high clinical
<br> suspicion of COVID-19
<br>
<br> - Requiring hospitalization
<br>
<br> Exclusion Criteria:
<br>
<br> - Known pregnancy at the time of screening
<br>
<br> - Inability to give informed consent or absence of legal representative who can give
<br> informed consent.
<br> | | COVID-19 | Procedure: Blood draw;Procedure: Bronchoalveolar lavage;Procedure: SARS CoV-2 swabs | Identification of cytokines and chemokines associated with COVID-19 severity and outcome.;Identification of cellular subsets that can predict COVID-19 severity and outcome.;SARS CoV-2 sequencing.→SARS CoV-2 sequencing.;Identification of cellular subsets that can predict COVID-19 severity and outcome.;Identification of cytokines and chemokines associated with COVID-19 severity and outcome. | | | | Yes | False | | |
| → | NCT04911790 | 1 November 2021→8 November 2021 | Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Adults | Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 18 Years and Older: A Multicenter,Open-label Study | | Sinovac Research and Development Co., Ltd. | 02/06/2021 | 20210602 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04911790 | Recruiting | No | 18 Years | N/A | All | June 5, 2021 | 121000 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 4 | China | ; ; ; ; ; ; ; ; ; ; ; ; | Xiaoqiang Liu, Doctor;Xing Fang;Zhaodan Sun;Fubing Wang;Dongjuan Zhang;Shicheng Guo;Yeqing Tong;Qiuyun Deng;Qing Wang;Ruizhi Zhang;Xiaoshu Zhang;Xiaoqiang Liu, Doctor;XiaoQiang Liu | | ;;;;;;;;;;;lxq7611@126.com;lxq7611@126.com | ;;;;;;;;;;;15911568282; | Yunnan Provincial Center for Disease Control and Prevention;Liaoning Provincial Center for Disease Control and Prevention;HeilongjiangProvincial Center for Disease Control and Prevention;Hefei Provincial Center for Disease Control and Prevention;Fujian Provincial Center for Disease Control and Prevention;Jiangxi Provincial Center for Disease Control and Prevention;Hubei Provincial Center for Disease Control and Prevention;Guangxi Center for Disease Control and Prevention;Chongqing Center for Disease Control and Prevention;Guizhou Provincial Center for Disease Control and Prevention;Gansu Provincial Center for Disease Control and Prevention; |
<br> Inclusion Criteria:
<br>
<br> - Have not received any COVID-19 vaccine in the past or at least one dose of CoronaVac
<br> manufactured by Sinovac Research and Development Co.,Ltd;
<br>
<br> - Population aged 18 years and above;
<br>
<br> - The subjects can understand and voluntarily sign the informed consent form and
<br> participate in the follow-up;
<br>
<br> Exclusion Criteria:
<br>
<br> - History of severe allergy to the vaccine such as acute allergic reaction,angioedema
<br> and dyspnea ;
<br>
<br> - Severe neurological disease such as transverse myeliti,Guillain-Barre Syndrome and
<br> demyelinating disorders;
<br>
<br> - Acute diseas,acute onset of chronic disease and severe chronic diseases.
<br> | | COVID-19 | Biological: Experimental Group | Safety index-incidence of adverse reactions | | | | Yes | False | | |
| → | NCT04927065 | 7 September 2021→8 November 2021 | A Study to Evaluate the Immunogenicity and Safety of mRNA-1273.211 Vaccine for COVID-19 Variants | A Phase 2/3 Study to Evaluate the Immunogenicity and Safety of mRNA Vaccine Boosters for SARS-CoV-2 Variants | | ModernaTX, Inc. | 14/06/2021 | 20210614 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04927065 | Not recruiting→Recruiting | No | 18 Years | N/A | All | May 28, 2021 | 1768→3620 | Interventional | Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 2/Phase 3 | United States | →␣ | →Moderna Clinical Trials | | →clinicaltrials@modernatx.com | →877-913-3286 | |
<br> Key Inclusion Criteria:
<br>
<br> - For female participants of childbearing potential: negative pregnancy test, adequate
<br> contraception or has abstained from all activities that could result in pregnancy for
<br> at least 28 days prior to Day 1, agreement to continue adequate contraception or
<br> abstinence through 3 months following the vaccination, and not currently
<br> breastfeeding.
<br>
<br> - Participant must have been previously enrolled in the mRNA-1273-P301 (COVE) study,
<br> must have received 2 doses of mRNA-1273 in Part A of that study (that is, already
<br> unblinded and aware of their actual treatment), with their second dose at least 6
<br> months prior to enrollment in this study (mRNA-1273-P205), and must be currently
<br> enrolled and compliant in that study (that is, has not withdrawn or discontinued
<br> early).
<br>
<br> Key Exclusion Criteria:
<br>
<br> - Significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14
<br> days, as defined by the US Centers for Disease Control and Prevention (CDC) as a close
<br> contact of someone who has had COVID-19.
<br>
<br> - Known history of SARS-CoV-2 infection including during the mRNA 1273-P301 (COVE)
<br> study.
<br>
<br> - Is acutely ill or febrile (temperature =38.0°Celsius/[100.4°Fahrenheit]) less than 72
<br> hours prior to or at the Screening Visit (Day 0) or Day 1.
<br>
<br> - Has a medical, psychiatric, or occupational condition that may pose additional risk as
<br> a result of participation, or that could interfere with safety assessments or
<br> interpretation of results according to the investigator's judgment.
<br>
<br> - Has received systemic immunosuppressants or immune-modifying drugs for >14 days in
<br> total within 6 months prior to Screening (for corticosteroids =10 milligrams (mg)/day
<br> of prednisone equivalent) or is anticipating the need for immunosuppressive treatment
<br> at any time during participation in the study.
<br>
<br> - Known or suspected allergy or history of anaphylaxis, urticaria, or other significant
<br> AR to the vaccine or its excipients.
<br>
<br> - Has a medical history consistent with a protocol-specified AESI.
<br>
<br> - Has received or plans to receive any licensed vaccine =28 days prior to the injection
<br> (Day 1) or a licensed vaccine within 28 days before or after they study injection,
<br> with the exception of influenza vaccines, which may be given 14 days before or after
<br> receipt of a study vaccine.
<br>
<br> - Has received systemic immunoglobulins or blood products within 3 months prior to the
<br> Screening Visit (Day 0) or plans for receipt during the study.
<br>
<br> - Has donated =450 milliliters (mL) of blood products within 28 days prior to the
<br> Screening Visit (Day 0) or plans to donate blood products during the study.
<br>
<br> - Is currently experiencing an SAE in Study mRNA-1273-P301 (COVE) at the time of
<br> screening for this study.
<br> →
<br> Key Inclusion Criteria:
<br>
<br> - For female participants of childbearing potential: negative pregnancy test, adequate
<br> contraception or has abstained from all activities that could result in pregnancy for
<br> at least 28 days prior to Day 1, agreement to continue adequate contraception or
<br> abstinence through 3 months following the vaccination, and not currently
<br> breastfeeding.
<br>
<br> - In Parts C and D, study participants must have been either previously enrolled in the
<br> mRNA-1273-P301 (COVE) study, must have received 2 doses of mRNA-1273 in that study,
<br> with their second dose at least 6 months prior to enrollment in this study
<br> (mRNA-1273-P205), and must be currently enrolled and compliant in that study (that is,
<br> has not withdrawn or discontinued early); or participant must have received 2 doses of
<br> mRNA-1273 under the Emergency Use Authorization (EUA) with their second dose at least
<br> 6 months prior to enrollment in mRNA-1273-P205, and able to provide proof of
<br> vaccination status at the time of screening (Day 1). In Part E, study participants
<br> must have previously received an mRNA vaccine for the prevention of COVID-19 in
<br> another clinical study or under EUA with their second dose at least 6 months prior to
<br> enrollment in mRNA-1273-P205 and must be able to provide proof of vaccination status
<br> at the time of screening (Day 1).
<br>
<br> Key Exclusion Criteria:
<br>
<br> - Significant exposure to someone with SARS-CoV-2 infection or COVID-19 in the past 14
<br> days, as defined by the US Centers for Disease Control and Prevention (CDC) as a close
<br> contact of someone who has had COVID-19.
<br>
<br> - Known history of SARS-CoV-2 infection including during the mRNA 1273-P301 (COVE) study
<br> or within the last 18 months.
<br>
<br> - Is acutely ill or febrile (temperature =38.0°Celsius/[100.4°Fahrenheit]) less than 72
<br> hours prior to or at the Screening Visit (Day 0) or Day 1.
<br>
<br> - Has a medical, psychiatric, or occupational condition that may pose additional risk as
<br> a result of participation, or that could interfere with safety assessments or
<br> interpretation of results according to the investigator's judgment.
<br>
<br> - Has received systemic immunosuppressants or immune-modifying drugs for >14 days in
<br> total within 6 months prior to Screening (for corticosteroids =10 milligrams (mg)/day
<br> of prednisone equivalent) or is anticipating the need for immunosuppressive treatment
<br> at any time during participation in the study.
<br>
<br> - Known or suspected allergy or history of anaphylaxis, urticaria, or other significant
<br> AR to the vaccine or its excipients.
<br>
<br> - Has a medical history consistent with a protocol-specified AESI.
<br>
<br> - Has received or plans to receive any licensed vaccine =28 days prior to the injection
<br> (Day 1) or a licensed vaccine within 28 days before or after they study injection,
<br> with the exception of influenza vaccines, which may be given 14 days before or after
<br> receipt of a study vaccine.
<br>
<br> - Has received systemic immunoglobulins or blood products within 3 months prior to the
<br> Screening Visit (Day 0) or plans for receipt during the study.
<br>
<br> - Has donated =450 milliliters (mL) of blood products within 28 days prior to the
<br> Screening Visit (Day 0) or plans to donate blood products during the study.
<br>
<br> - Is currently experiencing an SAE in Study mRNA-1273-P301 (COVE) at the time of
<br> screening for this study.
<br> | | SARS-CoV-2 | Biological: mRNA-1273.211;Biological: mRNA-1273;Biological: mRNA-1273.617.2→Biological: mRNA-1273.211;Biological: mRNA-1273;Biological: mRNA-1273.617.2;Biological: mRNA-1273.213 | Number of Participants with Serious AEs (SAEs), Medically Attended AEs (MAAEs), AEs Leading to Withdrawal, and AEs of Special Interest (AESIs);Number of Participants with Unsolicited Adverse Events (AEs);Number of Participants with Solicited Local and Systemic Reactogenicity Adverse Reactions (ARs);Seroresponse Rate of Vaccine Recipients;Geometric Mean Titer (GMT) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)-Specific Antibody | | | | Yes | False | | |
| → | NCT04937556 | 26 July 2021→8 November 2021 | Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease). | Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of the Lactobacillus Probiotic Strain in the Immune Response in Participants Positive for SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus-2) Infection. | PROVID | ProbiSearch SL | 14/06/2021 | 20210614 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04937556 | Not recruiting→Recruiting | No | 18 Years | 65 Years | All | August 1, 2021→October 25, 2021 | 60 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | N/A | →Spain | → ; | →SUSANA MANZANO, PhD;SERGIO IGLESIAS, MD | | →susana.manzano@probisearch.com; | →918035179; | |
<br> Inclusion Criteria:
<br>
<br> - Adult (18-65 years).
<br>
<br> - Mild infection by SARS-CoV-2 detected by PCR or Antigen.
<br>
<br> - Onset of COVID-19 symptoms up to 5 days before the day of inclusion
<br>
<br> - Without hospitalization or oxygen supplementation on the day of inclusion.
<br>
<br> - Signed written informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Serious SARS-CoV-2 infection requiring hospitalization or oxygen supply
<br>
<br> - Chronic diseases under regular medication (eg asthma, allergic rhinitis ...)
<br>
<br> - Congenital or acquired immunodeficiency
<br>
<br> - Body Mass Index (BMI)> 30
<br>
<br> - Coagulation disorders
<br>
<br> - Short bowel syndrome or any surgery on the gastrointestinal tract.
<br>
<br> - Metabolic disorders (diabetes, etc.).
<br>
<br> - Heart failure and cardiac medical history
<br>
<br> - Pregnant women.
<br>
<br> - HIV positive.
<br>
<br> - Immunocompromised
<br>
<br> - History of significant gastrointestinal diseases
<br>
<br> - Use of other probiotics during the last month.
<br>
<br> - Uncertainty about the willingness or ability of the participant to comply with the
<br> requirements of the protocol.
<br> | | Covid19 | Dietary Supplement: Probiotic: Lactobacillus salivarius + Vit D + Zinc;Dietary Supplement: Placebo | Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus. | | | | Yes | False | | |
| → | NCT04952402 | 1 November 2021→8 November 2021 | SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine | SARS-CoV-2 Immune Responses After COVID-19 Therapy and Subsequent Vaccine | | National Institute of Allergy and Infectious Diseases (NIAID) | 28/06/2021 | 20210628 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04952402 | Recruiting | No | 18 Years | N/A | All | July 16, 2021 | 700 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 4 | United States;Puerto Rico;United States | ; | David Smith, MD, MAS;Preeti Dhillon, MPH | | ;preeti.dhillon@dlhcorp.com | ;1-301-6283017 | UCSD Antiviral Research Center; |
<br> Inclusion Criteria:
<br>
<br> - For all participants: Ability and willingness of participant (or legally authorized
<br> representative) to provide informed consent prior to initiation of any study
<br> procedures.
<br>
<br> - For all participants: Individuals =18 years of age
<br>
<br> - For participants who are in, or who have completed, the ACTIV-2/A5401 trial: Receipt
<br> of all selected investigational therapy or active comparator/placebo for that therapy
<br> at selected sites.
<br>
<br> - For participants who are in, or who have completed, the ACTIV-2/A5401 trial and will
<br> be receiving study-provided Moderna mRNA-1273 COVID-19 vaccine: Receipt of the last
<br> dose of investigational therapy or active comparator/placebo for that therapy =60 days
<br> and =240 days prior to study entry.
<br>
<br> - For participants who are in, or who have completed, the ACTIV-2/A5401 trial and will
<br> be receiving community-provided mRNA-based COVID-19 vaccine: Receipt of the last dose
<br> of investigational therapy or active comparator/placebo for that therapy =60 and =240
<br> days prior to planned receipt of the first dose of community-provided vaccine.
<br>
<br> Exclusion Criteria:
<br>
<br> - For participants who are in, or who have completed, the ACTIV-2/A5401 trial:
<br> Self-report of prior receipt of a non-mRNA-based COVID-19 vaccine
<br>
<br> - For participants who are in, or who have completed, the ACTIV-2/A5401 trial:
<br> Self-report of receipt of the second dose of an mRNA-based COVID-19 vaccine.
<br>
<br> - For participants who are in, or who have completed, the ACTIV-2/A5401 trial:
<br> Self-report of a second SARS-CoV-2 infection after the infection that qualified the
<br> participant for ACTIV-2/A5401.
<br>
<br> - For non-A5401/ACTIV-2 participants: Self-report of receipt of any prior COVID-19
<br> vaccine.
<br>
<br> - For non-A5401/ACTIV-2 participants: Known prior history of any SARS-CoV-2-positive
<br> test (e.g., PCR test, Nucleic Acid Amplification Test (NAAT), antigen test, serology
<br> test).
<br>
<br> - For participants who will receive study-provided Moderna mRNA-1273 COVID-19 vaccine:
<br> Known allergy to any component of the Moderna COVID-19 vaccine.
<br> | | Covid19;SARS-CoV2 Infection | Biological: Moderna mRNA-1273 COVID-19 vaccine;Biological: Community-provided mRNA-based COVID-19 vaccine;Biological: Community-Provided Moderna mRNA-1273 COVID-19 Vaccine | Neutralizing antibody (NAb) level at least | | | | Yes | False | | |
| → | NCT04953078 | 13 September 2021→8 November 2021 | A Study to Evaluate Safety, Tolerability, and Reactogenicity of an RBD-Fc-based Vaccine to Prevent COVID-19 | A Phase 1, Randomized, Open-label, Dose-Finding Study to Evaluate the Safety, Tolerability, and Reactogenicity of Escalating Doses of the Baiya SARS-CoV-2 Vax 1 Vaccine in Healthy Adults | | Baiya Phytopharm Co., Ltd. | 14/06/2021 | 20210614 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04953078 | Not recruiting→Recruiting | No | 18 Years | 75 Years | All | September 2021→September 11, 2021 | 96 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1 | →Thailand | →␣ | →Peepattra Wantanasiri, Ph.D. | | →peepattra.w@baiyaphytopharm.com | →662 115 9860 | |
<br> Inclusion Criteria:
<br>
<br> - Healthy man and woman between 18-?60 years old (inclusive) for the adult cohort and
<br> between 61-75 years old (inclusive) for the elderly cohort.
<br>
<br> - Have a body-mass index of 18.0-30.0 kg/m² at screening
<br>
<br> - Give informed consent prior to study enrollment and all study procedures
<br>
<br> - Participants must be able to comply with study procedures and be available for all
<br> study visits
<br>
<br> - Participants must be in general good health based on medical history and physical
<br> examination as determined by the investigator(s) at Screening
<br>
<br> - Participants must have haematology, clinical chemistry, coagulation, and urinalysis
<br> test results that are not deviating from the normal reference range by age and gender
<br> to a clinically relevant extent at Screening
<br>
<br> - Males must be surgically sterile (>30 days since vasectomy with no viable sperm),
<br> practice true abstinence, or, if engaged in sexual activities with a female with
<br> childbearing potential, use condoms from first vaccination until 60 days after the
<br> last vaccination.
<br>
<br> - Females of child-bearing potential must practice true abstinence, or, if engaged in
<br> sexual activities with a male, agree to use highly effective (failure rate of <1% per
<br> year when used consistently and correctly), double-barrier contraceptive measures
<br> throughout the study and intend to continue use of contraception methods for at least
<br> 60 days following the last vaccination.
<br>
<br> - Female participants of child-bearing potential must have negative serum pregnancy test
<br> by beta human chorionic gonadotropin [ß-HCG] at Screening and a negative urine-based
<br> pregnancy test within 24 hours prior to each investigational vaccine administration
<br>
<br> - Female participants of childbearing potential must not be pregnant or breastfeeding.
<br>
<br> - Women of non-child-bearing potential must:
<br>
<br> 1. be classified as being postmenopausal (defined as having a history of amenorrhea
<br> for at least one year), or
<br>
<br> 2. where history of amenorrhea is less than one year, female participants must have
<br> a follicle stimulating hormone (FSH) level > 40 milli-international units per
<br> millilitre (mIU/mL), or
<br>
<br> 3. have a documented status of being surgically sterile (hysterectomy, bilateral
<br> oophorectomy, or /salpingectomy).
<br>
<br> - All volunteers will be screened for serum antibodies against SARS-CoV-2, as evidence
<br> of previous infection using Enzyme-Linked Immunosorbent Assay (ELISA) and must have a
<br> negative result
<br>
<br> - Body temperature measured at forehead using validated device must be less than 37.5ºC
<br> at Screening.
<br>
<br> - Pulse must be no greater than 100 beats per minute, at Screening
<br>
<br> - Systolic blood pressure (SBP) must be between 85 to 150 millimeters of mercury (mm
<br> Hg), inclusive, at Screening
<br>
<br> - Participants must agree to refrain from donating blood, plasma, ovules, sperm, or
<br> organs during the whole study
<br>
<br> Exclusion Criteria:
<br>
<br> - Presence of clinically significant medical history, unstable chronic or acute disease,
<br> or physical, or laboratory findings that in the opinion of the PI may potentially
<br> increase the expected risk of exposure to the investigational vaccine, compromise the
<br> safety of the participant, or interfere with any aspect of study conduct or
<br> interpretation of results. This will include any thrombocytopenia or bleeding disorder
<br> contraindicating IM vaccination.
<br>
<br> - Presence of self-reported or medically documented significant medical or psychiatric
<br> condition(s) as judged by the investigator(s) that it may not be in the participant's
<br> interest to participate in the study.
<br>
<br> - Presence of an acute illness, as determined by the participating Study Site
<br> investigator(s), with or without fever (forehead temperature measured by validated
<br> device = 37.5 ºC) within 72 hours prior to each vaccination
<br>
<br> - Presence of birthmarks, tattoos, wound, or other skin conditions over the deltoid
<br> region of both arms that in the opinion of the investigator(s), could reasonably
<br> obscure and interfere with evaluation of local ISRs
<br>
<br> - Inadequate venous access to allow collection of blood samples
<br>
<br> - Breastfeeding or planning to breastfeed from the time of the first vaccination to
<br> after the last vaccination, or pregnant as confirmed by a positive serum ß-HCG
<br> pregnancy test at Screening or positive urine pregnancy test at subsequent clinic
<br> visits at timepoints as delineated in the schedule of assessments
<br>
<br> - Received any prophylactic or therapeutic vaccine, or licensed or unlicensed vaccine,
<br> device, or blood product, within 4 weeks of first vaccination or 5 half-lives
<br> (whichever is longer), or anticipate to do so in the follow-up period defined for this
<br> study
<br>
<br> - History of severe allergy (requiring hospital care), anaphylaxis, severe reaction to
<br> any drug or prior vaccination, or any known or suspected allergies or sensitivities to
<br> any component of the investigational vaccine or tobacco
<br>
<br> - Participant is immunosuppressed as caused by disease (such as HIV)
<br>
<br> - Chronic use (more than 14 continuous days) of or anticipated need to use, within the
<br> next 6 months, of any medications that may be associated with impaired immune
<br> responsiveness or with immunosuppression
<br>
<br> - History of hepatitis B or hepatitis C infection
<br>
<br> - Receipt of immunoglobulins or blood products within 90 days of the first vaccination
<br>
<br> - Requirement for antipyretic or analgesic medication on a daily or every other day
<br> basis from enrolment through 72 hours after vaccination
<br>
<br> - Current use of any prescription or over-the-counter medications within 7 days prior to
<br> vaccination, unless approved by the PI
<br>
<br> - Receipt of other investigational products (drug, biologic or device) within 60 days
<br> before the first vaccination
<br>
<br> - History of alcohol or drug abuse that in the opinion of the PI could affect the
<br> participant's safety or compliance with study
<br>
<br> - Participant is unwilling to abstain from blood donation during the course of the
<br> study, and/or is participating in any research study involving blood sampling (more
<br> than 450 mL /unit of blood), or blood donation to any blood bank during the 2 months
<br> prior to the Screening visit
<br>
<br> - Participant is unwilling to abstain from donating plasma, ovules, sperm, or organs
<br> during the course of the study
<br>
<br> - Close contact with anyone known to have SARS-CoV-2 infection within 30 days prior to
<br> vaccine administration
<br>
<br> - History of COVID-19 diagnosis
<br>
<br> | | Coronavirus | Biological: Baiya SARS-CoV-2 Vax 1 | Frequency and Grade of Solicited Adverse Events;Frequency and Grade of Adverse Events;Incidence of Serious Adverse Events (SAEs), Medically-Attended Adverse Events (MAAEs), and New-Onset Chronic Medical Conditions (NOCMCs);Changes in Blood Pressure (Systolic and Diastolic Blood Pressure) from Baseline;Changes in Pulse Rate from Baseline;Changes in Respiratory Rate from Baseline;Changes in Oral Body Temperature from Baseline;Changes in Physical Conditions from Baseline Physical Examinations;Safety Laboratory Value (Haematology);Safety Laboratory Value (Serum chemistry);Safety Laboratory Value (Coagulation);Safety Laboratory Value (Urinalysis);Treatment-emergent Changes in Blood Pressure;Treatment-emergent Changes in Pulse Rate;Treatment-emergent Changes in Respiratory Rate;Treatment-emergent Changes in Body Temperature;Treatment-emergent, Changes in Physical Conditions→Frequency and Grade of Solicited Adverse Events;Frequency and Grade of Adverse Events (including both solicited and unsolicited AEs);Incidence of Serious Adverse Events (SAEs), Medically-Attended Adverse Events (MAAEs), and New-Onset Chronic Medical Conditions (NOCMCs);Changes in Blood Pressure (Systolic and Diastolic Blood Pressure) from Baseline;Changes in Pulse Rate from Baseline;Changes in Respiratory Rate from Baseline;Changes in Body Temperature from Baseline;Changes in Physical Conditions from Baseline Physical Examinations;Safety Laboratory Value (Haematology);Safety Laboratory Value (Serum chemistry);Safety Laboratory Value (Coagulation);Safety Laboratory Value (Urinalysis);Treatment-emergent Changes in Blood Pressure;Treatment-emergent Changes in Pulse Rate;Treatment-emergent Changes in Respiratory Rate;Treatment-emergent Changes in Body Temperature;Treatment-emergent, Changes in Physical Conditions | | | | Yes | False | | |
| → | NCT04954222 | 1 November 2021→8 November 2021 | Recovery of Respiratory System in COVID-19 Patients | Tracking the Recovery of Respiratory Physiology in COVID-19 Patients a Pilot Study | | Mayo Clinic | 30/06/2021 | 20210630 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04954222 | Not recruiting | No | 18 Years | N/A | All | November 30, 2021 | 80 | Observational | | | United States | | Bruce D Johnson, PhD | | | | Mayo Clinic |
<br> Inclusion Criteria:
<br>
<br> - Have a documented positive qRT-PCR for SARS-CoV-2 confirming prior COVID-19 diagnosis
<br> within the last 28 days
<br>
<br> - At least 18 years of age.
<br>
<br> - Female subjects must not be pregnant or trying to become pregnant during the duration
<br> of study participation.
<br>
<br> - No known plans to move out of the state, or become unable to return to one of the Mayo
<br> Clinic sites for follow-up testing.
<br>
<br> - Must be able to provide clear informed written consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Individuals with pacemakers or other implantable devices that will make interpreting a
<br> CT scan challenging.
<br>
<br> - Individuals with major limitations to exercise.
<br> | | Covid19 | | change in quality of life;Change in symptoms;Presence of post-exertional malaise;Change in peak aerobic capacity;change basic spirometry;Change in airway morphology;Change in diffusion capacity of the lungs→Change in diffusion capacity of the lungs;Change in airway morphology;change basic spirometry;Change in peak aerobic capacity;Presence of post-exertional malaise;change in quality of life;Change in symptoms | | | | Yes | False | | |
| → | NCT04955626 | 1 November 2021→8 November 2021 | Study to Evaluate the Safety and Efficacy of a Booster Dose of BNT162b2 Against COVID-19 in Participants =16 Years of Age. | A PHASE 3 MASTER PROTOCOL TO EVALUATE ADDITIONAL DOSE(S) OF BNT162B2 IN HEALTHY INDIVIDUALS PREVIOUSLY VACCINATED WITH BNT162B2 | | BioNTech SE | 09/06/2021 | 20210609 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04955626 | Recruiting | No | 16 Years | N/A | All | July 1, 2021 | 10000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | United States;Brazil;Canada;South Africa;Brazil;Canada;South Africa;United States | ; | Pfizer CT.gov Call Center;Pfizer CT.gov Call Center | | ;ClinicalTrials.gov_Inquiries@pfizer.com | ;1-800-718-1021 | Pfizer; |
<br> Inclusion Criteria:
<br>
<br> - Male or female participants =16 years of age at Visit 1 (Day 1) who participated in
<br> C4591001.
<br>
<br> - Participants who are willing and able to comply with all scheduled visits, vaccination
<br> plan, laboratory tests, lifestyle considerations, and other study procedures.
<br>
<br> - Healthy participants who are determined by medical history, physical examination (if
<br> required), and clinical judgment of the investigator to be eligible for inclusion in
<br> the study.
<br>
<br> - Capable of giving signed informed consent.
<br>
<br> - Participants who have received 2 prior doses of 30 µg BNT162b2 19-42 days apart, with
<br> the second dose being at least 175 days before Visit 1 (Day 1).
<br>
<br> Exclusion Criteria:
<br>
<br> - Other medical or psychiatric condition including recent (within the past year) or
<br> active suicidal ideation/behavior or laboratory abnormality that may increase the risk
<br> of study participation or, in the investigator's judgment, make the participant
<br> inappropriate for the study.
<br>
<br> - History of severe adverse reaction associated with a vaccine and/or severe allergic
<br> reaction (eg, anaphylaxis) to any component of the study intervention.
<br>
<br> - Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result
<br> was not available) or microbiological (based on COVID-19 symptoms/signs and a positive
<br> SARS-CoV-2 NAAT result) diagnosis of COVID-19.
<br>
<br> - Immunocompromised individuals with known or suspected immunodeficiency, as determined
<br> by history and/or laboratory/physical examination.
<br>
<br> - Bleeding diathesis or condition associated with prolonged bleeding that would, in the
<br> opinion of the investigator, contraindicate intramuscular injection.
<br>
<br> - Women who are pregnant or breastfeeding.
<br>
<br> - Individuals who receive treatment with radiotherapy or immunosuppressive therapy,
<br> including cytotoxic agents or systemic corticosteroids, eg, for cancer or an
<br> autoimmune disease, or planned receipt throughout the study.
<br>
<br> - Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60
<br> days before study intervention administration, or receipt of any passive antibody
<br> therapy specific to COVID-19, from 90 days before study intervention administration,
<br> or planned receipt throughout the study.
<br>
<br> - Prior receipt of any COVID-19 vaccine other than BNT162b2.
<br>
<br> - Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct
<br> of the study, site staff otherwise supervised by the investigator, and their
<br> respective family members.
<br>
<br> - Receipt of medications intended to prevent COVID-19.
<br>
<br> - Prior receipt of more than 2 doses of BNT162b2 30 µg.
<br>
<br> - Participation in other studies involving study intervention within 28 days prior to
<br> study entry, other than C4591001, and/or within 28 days of confirmed receipt of
<br> BNT162b2 within the study.
<br> | | SARS-CoV-2 Infection;COVID-19 | Biological: BNT162b2;Other: Placebo | Confirmed COVID-19 incidence in participants without evidence of past SARS-CoV-2 infection;Confirmed COVID-19 incidence in participants with and without evidence of past SARS-CoV-2 infection;Percentage of participants reporting adverse events;Percentage of participants reporting serious adverse events | | | | Yes | False | | |
| → | NCT04958161 | 13 September 2021→8 November 2021 | Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms | Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms | RECOVERY | Wake Forest University Health Sciences | 08/07/2021 | 20210708 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04958161 | Not recruiting | No | 55 Years | N/A | All | October 2021→November 2021 | 15 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | United States | ; ; | Michael J Berry, PhD;Michael J Berry, PhD;Michael J Berry, PhD | | ;berry@wfu.edu;berry@wfu.edu | ;336-758-5847;336-758-5847 | Wake Forest University; |
<br> Inclusion Criteria:
<br>
<br> - 55 years of age or older
<br>
<br> - Able to read and speak English
<br>
<br> - Proof of a positive nucleic acid amplification test for the determination of COVID-19
<br>
<br> - Two months post positive nucleic acid amplification test for the determination of
<br> COVID
<br>
<br> - Self-report of COVID-19 symptoms (symptoms include any of the following: reduced
<br> exercise capacity, fatigue, cough, shortness of breath, headache and/or joint pain)
<br>
<br> - Able to understand and willing to sign a written informed consent document
<br>
<br> - Willing and able to complete all study procedures including attending all exercise
<br> sessions
<br>
<br> Exclusion Criteria:
<br>
<br> - Currently exercising more than 60 minutes per week at a moderate intensity or 30
<br> minutes per week at a high intensity
<br>
<br> - Current use of supplemental oxygen
<br>
<br> - Active treatment for cancer
<br>
<br> - Severe congestive heart failure, pulmonary disease, stroke, peripheral vascular
<br> disease, coronary artery disease and/or valvular heart disease
<br>
<br> - Positive graded exercise test
<br>
<br> - Major psychiatric disease
<br>
<br> - Severe liver or hepatic disease
<br>
<br> - Uncontrolled hypertension or diabetes
<br>
<br> - Orthopedic impairment that prevents participation in an exercise program
<br>
<br> - Blindness
<br>
<br> - BMI > 40kg/m2
<br>
<br> - Living more than 35 miles from exercise facility
<br>
<br> - Plans to move within the next 6 months
<br> | | Covid19 | Other: Exercise Therapy | Self-reported Physical Function;Self-reported Physical Function;Performance Based Physical Function;Performance Based Physical Function→Performance Based Physical Function;Performance Based Physical Function;Self-reported Physical Function;Self-reported Physical Function | | | | Yes | False | | |
| → | NCT04960202 | 1 November 2021→8 November 2021 | A Study of PF-07321332/Ritonavir in Nonhospitalized High Risk Adult Participants With COVID-19 | AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT INCREASED RISK OF PROGRESSING TO SEVERE ILLNESS | | Pfizer | 10/07/2021 | 20210710 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04960202 | Recruiting | Yes | 18 Years | N/A | All | July 16, 2021 | 3000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States;Argentina;Brazil;Bulgaria;Colombia;Czechia;Hungary;India;Japan;Korea, Republic of;Malaysia;Mexico;Poland;Puerto Rico;Russian Federation;South Africa;Spain;Taiwan;Thailand;Turkey;Ukraine;Argentina;Brazil;Bulgaria;Colombia;Czechia;Hungary;India;Japan;Korea, Republic of;Malaysia;Mexico;Poland;Puerto Rico;Russian Federation;South Africa;Spain;Taiwan;Thailand;Turkey;Ukraine;United States | ; | Pfizer CT.gov Call Center;Pfizer CT.gov Call Center | | ;ClinicalTrials.gov_Inquiries@pfizer.com | ;1-800-718-1021 | Pfizer; |
<br> Inclusion Criteria:
<br>
<br> - Confirmed SARS-CoV-2 infection within 5 days prior to randomization
<br>
<br> - Initial onset of COVID-19 signs/symptoms within 5 days prior to the day of
<br> randomization and at least 1 of the specified COVID-19 signs/symptoms present on the
<br> day of randomization
<br>
<br> - Fertile participants must agree to use a highly effective method of contraception
<br>
<br> - Has at least 1 characteristic or underlying medical condition associated with an
<br> increased risk of developing severe illness from COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> - History of or need for hospitalization for the medical treatment of COVID-19
<br>
<br> - Prior to current disease episode, any confirmed SARS-CoV-2 infection
<br>
<br> - Known medical history of active liver disease
<br>
<br> - Receiving dialysis or have known moderate to severe renal impairment
<br>
<br> - Known human immunodeficiency virus (HIV) infection with a viral load greater than 400
<br> copies/mL or taking prohibited medications for HIV treatment
<br>
<br> - Suspected or confirmed concurrent active systemic infection other than COVID-19
<br>
<br> - History of hypersensitivity or other contraindication to any of the components of the
<br> study intervention
<br>
<br> - Current or expected use of any medications or substances that are highly dependent on
<br> CYP3A4 for clearance or are strong inducers of CYP3A4
<br>
<br> - Has received or is expected to receive convalescent COVID-19 plasma
<br>
<br> - Has received or is expected to receive any dose of a SARS-CoV-2 vaccine before the Day
<br> 34 visit
<br>
<br> - Participating in another interventional clinical study with an investigational
<br> compound or device, including those for COVID-19 through the long-term follow-up visit
<br>
<br> - Known prior participation in this trial or other trial involving PF-07321332
<br>
<br> - Oxygen saturation of <92% on room air, or on their standard home oxygen
<br> supplementation for those who regularly receive chronic supplementary oxygen for an
<br> underlying lung condition
<br>
<br> - Females who are pregnant or breastfeeding
<br> | | COVID-19 | Drug: PF-07321332;Drug: Ritonavir;Drug: Placebo | Proportion of participants with COVID-19 related hospitalization or death from any cause | | | | Yes | True | parent | |
| → | NCT04960228 | 1 November 2021→8 November 2021 | Exploring Changes in COVID-19 Vaccination Intentions by Prompting Altruistic Motives Using a Video Intervention | Enhancing COVID-19 Vaccination Intentions by Eliciting Prosocial Altruistic Motives: Evaluating the Efficacy of a Brief Video-Based Intervention | | Zeev Rosberger | 30/06/2021 | 20210630 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04960228 | Not recruiting | No | 20 Years | 39 Years | All | July 30, 2021 | 1623 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Investigator). | N/A | Canada | | Zeev Rosberger, PhD | | | | Lady Davis Institute for Medical Research of the Jewish General Hospital |
<br> Inclusion Criteria:
<br>
<br> - Residing within Canada and aged between 20 and 39 years.
<br>
<br> Exclusion Criteria:
<br>
<br> - Having received at least one dose of a COVID-19 vaccine
<br> | | Vaccine Refusal | Behavioral: Altruism Video;Behavioral: COVID-19 Informational Text | Change in Vaccine Intentions Pre-Post Intervention | | | | Yes | False | | |
| → | NCT04973449 | 27 September 2021→8 November 2021 | Phase II/III Study of AZD2816, for the Prevention of COVID-19 in Adults | A Phase II/III Partially Double-Blinded, Randomised, Multinational, Active-Controlled Study in Adults to Determine the Safety and Immunogenicity of AZD2816, a Vaccine for the Prevention of COVID-19 | AZD2816 | AstraZeneca | 02/07/2021 | 20210702 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04973449 | Recruiting | No | 18 Years | 115 Years | All | June 27, 2021 | 2849 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United Kingdom;South Africa;Poland;Brazil;United Kingdom;South Africa;Poland;Brazil→Brazil;Poland;South Africa;United Kingdom;Brazil;Poland;South Africa;United Kingdom | | AstraZeneca Clinical Study Information Center | | information.center@astrazeneca.com | 1-877-240-9479 | |
<br> Inclusion Criteria:
<br>
<br> 1. Adult, = 18 years of age at the time of consent
<br>
<br> For inclusion in the SARS-CoV-2 seronegative population:
<br>
<br> 2. No history of laboratory-confirmed SARS-CoV-2 infection (ie, no positive nucleic acid
<br> amplification test and no positive antibody test).
<br>
<br> 3. Seronegative for SARS-CoV-2 at screening (lateral flow test to detect reactivity to
<br> the nucleoprotein).
<br>
<br> 4. Medically stable such that, according to the judgment of the investigator,
<br> hospitalization within the study period is not anticipated and the participant appears
<br> likely to be able to remain on study through the end of protocol-specified follow-up
<br>
<br> 5. Able to understand and comply with study requirements/procedures (if applicable, with
<br> assistance by caregiver, surrogate, or legally authorized representative) based on the
<br> assessment of the investigator
<br>
<br> 6. Signed informed consent obtained before conducting any study-related procedures
<br>
<br> 7. Contraceptive use by women should be consistent with local regulations regarding the
<br> methods of contraception for those participating in clinical studies.
<br>
<br> Previously COVID-19 Vaccinated Participants:
<br>
<br> 8. Prior completion of a 2-dose primary homologous vaccination regimen against SARSCoV-2
<br> with either AZD1222 (2 standard doses as authorized vaccine or as investigational
<br> product in a clinical trial with a 4 to 12-week dosing interval) or with an mRNA
<br> vaccine approved for emergency or conditional use. The second dose in all cases should
<br> have been administered at least 3 months prior to first administration of study
<br> intervention.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. History of allergy to any component of AZD1222/AZD2816.
<br>
<br> 2. History of Guillain-Barré syndrome, any demyelinating disease, or any other
<br> neuroimmunologic condition
<br>
<br> 3. Significant infection or other acute illness, including fever > 100 °F (> 37.8 °C) on
<br> the day prior to or day of randomization
<br>
<br> 4. Any confirmed or suspected immunosuppressive or immunodeficient state, including
<br> asplenia or HIV/AIDS.
<br>
<br> 5. Recurrent severe infections and use of immunosuppressant medication within the past 6
<br> months (= 20 mg per day of prednisone or its equivalent, given daily or on alternate
<br> days for = 15 days within 30 days prior to administration of study intervention). The
<br> following exceptions are permitted: Topical/inhaled steroids or short-term oral
<br> steroids (course lasting = 14 days)
<br>
<br> 6. History of primary malignancy (see protocol)
<br>
<br> 7. History of thrombocytopenia and/or thrombosis, including participants who have
<br> experienced major venous and/or arterial thrombosis in combination with
<br> thrombocytopenia following vaccination with any COVID-19 vaccine
<br>
<br> 8. History of heparin-induced thrombocytopenia, congenital thrombophilia (ie, factor V
<br> Leiden, prothrombin G20210A, antithrombin III deficiency, protein C deficiency and
<br> protein S deficiency, factor XIII mutation, familial dysfibrinogenemia), auto-immune
<br> thrombophilia (antiphospholipid syndrome, anti-cardiolipin antibodies, anti-ß2-
<br> glycoprotein 1 antibodies), or paroxysmal nocturnal haemoglobinuria.
<br>
<br> 9. Clinically significant bleeding (eg, factor deficiency, coagulopathy, or platelet
<br> disorder), or prior history of significant bleeding or bruising following
<br> intramuscular injections or venepuncture
<br>
<br> 10. Severe and/or uncontrolled cardiovascular disease, respiratory disease,
<br> gastrointestinal disease, liver disease, renal disease, endocrine disorder, or
<br> neurological illness, as judged by the Investigator
<br>
<br> 11. Any other significant disease, disorder, or finding that may significantly increase
<br> the risk to the participant because of participation in the study, affect the ability
<br> of the participant to participate in the study, or impair interpretation of the study
<br> data
<br>
<br> 12. Any autoimmune conditions, except mild psoriasis and vitiligo.
<br> | | COVID-19;SARS-CoV-2 | Biological: AZD1222;Biological: AZD2816 | To determine if the response against the B.1.351 variant elicited by a 2-dose AZD2816 vaccination is non-inferior to the response against the original Wuhan-hu-1 strain elicited by a 2-dose AZD1222 vaccination in the naïve unvaccinated cohort;To determine if the response against B.1.351 elicited by an AZD2816 booster dose in participants previously vaccinated with AZD1222 is non-inferior to the response against Wuhan-hu-1 strain elicited by 2-dose AZD1222 administered to naïve participants;The safety and tolerability of a 2-dose primary vaccination with AZD2816 in the naïve unvaccinated cohort;The safety and tolerability of a 2-dose primary vaccination with AZD2816 in the naïve unvaccinated cohort;The safety and tolerability of 1 dose of AZD2816 in the previously vaccinated cohort with AZD1222;The safety and tolerability of 1 dose of AZD2816 in the previously vaccinated cohort with AZD1222→To determine if the response against the B.1.351 variant elicited by a 2-dose AZD2816 vaccination is non-inferior to the response against the original Wuhan-Hu-1 strain elicited by a 2-dose AZD1222 vaccination in the unvaccinated cohort;To determine if the response against B.1.351 elicited by an AZD2816 booster dose in participants previously vaccinated with AZD1222 is non-inferior to the response against Wuhan-Hu-1 strain elicited by 2-dose AZD1222 administered to naïve participants;The safety and tolerability of a 2-dose primary vaccination with AZD2816 in the unvaccinated cohort;The safety and tolerability of a 2-dose primary vaccination with AZD2816 in the unvaccinated cohort;The safety and tolerability of 1 dose of AZD2816 in the previously vaccinated cohort with AZD1222;The safety and tolerability of 1 dose of AZD2816 in the previously vaccinated cohort with AZD1222 | | | | Yes | False | | |
| +++ | NCT04980326 | 8 November 2021 | A Scalable Psychological Intervention to Reduce Psychological Distress Among Healthcare Workers | A Scalable Low-intensity Psychological Intervention to Reduce Psychological Distress Among Healthcare Workers Involved in the First COVID-19 Outbreak in Spain: a Randomized Trial | RESPOND-HCW | Instituto de Investigación Hospital Universitario La Paz | 16/07/2021 | 20210716 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04980326 | Not recruiting | No | 18 Years | N/A | All | November 1, 2021 | 212 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Outcomes Assessor). | N/A | Spain | ; ; ; | José Luis Ayuso-Mateos, MD, PhD;María Fe Bravo-Ortiz, MD, PhD;Josep Maria Haro, MD, PhD;Roberto Mediavilla, PhD | | ;;;roberto.mediavilla@uam.es | ;;;0034914972447 | Universidad Autonoma de Madrid;Hospital Universitario La Paz;Parc Sanitari Sant Joan de Déu; |
<br> Inclusion criteria:
<br>
<br> - 18 years or older;
<br>
<br> - Living in Madrid or Barcelona
<br>
<br> - Having elevated levels of psychological distress (Kessler Psychological Distress Scale
<br> (K10) >15.9).
<br>
<br> - Written/digital informed consent before entering the study.
<br>
<br> Exclusion criteria:
<br>
<br> - Having acute medical conditions (requiring hospitalization)
<br>
<br> - Imminent suicide risk, or expressed acute needs, or protection risks that require
<br> immediate follow-up
<br>
<br> - Having a severe mental disorder (e.g., psychotic disorders, substance-dependence)
<br>
<br> - Having severe cognitive impairment (e.g., severe intellectual disability or dementia)
<br>
<br> - Currently specialized psychological treatment (e.g., Eye movement desensitization and
<br> reprocessing, Cognitive behavioral therapy)
<br>
<br> - In case of current psychotropic medication use, not being on a stable dose during the
<br> past 2 months being on an unstable dose for at least 2 months.
<br> | | Psychological Distress;Depression;Anxiety | Behavioral: Doing What Matters (DWM);Behavioral: Problem Management Plus (PM+);Behavioral: Psychological First Aid (PFA) | Patient Health Questionnaire Anxiety and Depression Scale (PHQ-ADS) | | | | Yes | False | | |
| → | NCT04980573 | 10 August 2021→8 November 2021 | Essential Oils and Post COVID-19 Fatigue | The Effects of Aromatherapy on Post COVID-19 Fatigue: A Randomized, Double Blind, Controlled Trial | | Franklin School of Integrative Health Sciences | 26/07/2021 | 20210726 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04980573 | Not recruiting | No | 19 Years | 49 Years | All | July 28, 2021→August 5, 2021 | 44→47 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor). | N/A | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Age 19-49
<br>
<br> - Lives in the United States
<br>
<br> - Otherwise Healthy
<br>
<br> - COVID-19 Diagnosis between December 1, 2020 and March 31, 2021
<br>
<br> - Decreased energy or fatigue at a level that was not present prior to the diagnosis
<br>
<br> Exclusion Criteria:
<br>
<br> - Positive COVID-19 test any time before December 1, 2020
<br>
<br> - Positive COVID-19 test any time after March 31, 2021
<br>
<br> - COVID vaccine of any type scheduled during the intervention period or the week prior
<br> to the start of the study
<br>
<br> - Allergy to any of the ingredients
<br>
<br> - Pregnant, trying to conceive, or breastfeeding
<br>
<br> - Regular smokers in the home
<br>
<br> - Abnormal pulmonary function
<br>
<br> - Chest pain
<br>
<br> - Recurring headaches
<br>
<br> - Uncontrolled hypertension
<br>
<br> - Chronic Fatigue Syndrome diagnosis
<br>
<br> - Persistent fatigue prior to COVID-19 diagnosis
<br>
<br> - Hypothyroidism
<br> | | Covid19;Fatigue | Other: Aromatherapy;Other: Placebo | Change from baseline on the Multidimensional Fatigue Symptom Inventory (MFSI) at day 14. | | | | Yes | False | | |
| → | NCT04992208 | 1 November 2021→8 November 2021 | Safety of an Inactivated SARS-CoV-2 Vaccine for Prevention of COVID-19 in Children and Adolescents | Safety Observation of the Inactivated SARS-CoV-2 Vaccine (Vero Cell) in Population Aged 3~17 Years : A Multicenter,Open-label Study | | Sinovac Research and Development Co., Ltd. | 02/08/2021 | 20210802 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04992208 | Recruiting | No | 3 Years | 17 Years | All | July 24, 2021 | 33000 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 4 | China | ; ; ; ; ; ; ; ; ; ; ; ; | Xiaoqiang Liu, Doctor;Xing Fang;Zhaodan Sun;Fubing Wang;Dongjuan Zhang;Shicheng Guo;Yeqing Tong;Qiuyun Deng;Qing Wang;Ruizhi Zhang;Xiaoshu Zhang;Xiaoqiang Liu, Doctor;XiaoQiang Liu | | ;;;;;;;;;;;lxq7611@126.com;lxq7611@126.com | ;;;;;;;;;;;15911568282; | Yunnan Provincial Center for Disease Control and Prevention;Liaoning Provincial Center for Disease Control and Prevention;HeilongjiangProvincial Center for Disease Control and Prevention;Hefei Provincial Center for Disease Control and Prevention;Fujian Provincial Center for Disease Control and Prevention;Jiangxi Provincial Center for Disease Control and Prevention;Hubei Provincial Center for Disease Control and Prevention;Guangxi Center for Disease Control and Prevention;Chongqing Center for Disease Control and Prevention;Guizhou Provincial Center for Disease Control and Prevention;Gansu Provincial Center for Disease Control and Prevention; |
<br> Inclusion Criteria:
<br>
<br> - Have not received any COVID-19 vaccine in the past or at least one dose of CoronaVac
<br> manufactured by Sinovac Research and Development Co.,Ltd;
<br>
<br> - Population aged 3~17 years ;
<br>
<br> - The subjects can understand and voluntarily sign the informed consent form and
<br> participate in the follow-up;
<br>
<br> Exclusion Criteria:
<br>
<br> - History of severe allergy to the vaccine such as acute allergic reaction,angioedema
<br> and dyspnea ;
<br>
<br> - Severe neurological disease such as Myelitis transverse,Guillain-Barre Syndrome and
<br> demyelinating disorders;
<br>
<br> - Acute disease,acute onset of chronic disease and severe chronic diseases.
<br> | | COVID-19 | Biological: Experimental Group | Safety index 1-incidence of adverse reactions | | | | Yes | False | | |
| → | NCT04993560 | 1 November 2021→8 November 2021 | Safety and Efficacy of COVID-19 Prime-boost Vaccine in Bahrain | Comparing the Safety and Efficacy of Homologous and Heterologous COVID-19 Prime-boost Vaccination in Bahrain | | Royal College of Surgeons in Ireland - Medical University of Bahrain | 04/08/2021 | 20210804 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04993560 | Not recruiting | No | 21 Years | N/A | All | July 18, 2021 | 305 | Observational | | | Bahrain | | Manaf AlQahtani, Dr. | | | | Royal College of Surgeons in Ireland - Bahrain |
<br> Inclusion Criteria:
<br>
<br> - Adults aged =21yo.
<br>
<br> - Asymptomatic 24h before the administration of booster dose.
<br>
<br> - Has no active or previous RT-PCR lab-confirmed COVID-19 diagnosis.
<br>
<br> - Completed three months to six months after the second dose of BBIBP-CorV.
<br>
<br> - Have at least one Antibody test done before receiving the BBIBP-CorV booster dose OR
<br> can be done if the participant is yet to receive the BNT162b2 booster dose.
<br>
<br> - Tested negative using Rapid Antigen Detection Test on the day of receiving the booster
<br> (positive results will confirm with RT-PCR).
<br>
<br> - Study participants must have the ability to give informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Children aged <21yo.
<br>
<br> - Symptomatic within 24h before the administration of booster dose.
<br>
<br> - Has active or previous RT-PCR lab-confirmed COVID-19 diagnosis.
<br>
<br> - Did not complete three months to six months after the second dose of BBIBP-CorV.
<br>
<br> - Does not have at least one Antibody test done before receiving the BBIBP-CorV booster
<br> dose
<br>
<br> - Tested positive using Rapid Antigen Detection Test on the day of receiving the booster
<br> (positive results will be confirmed with PCR).
<br>
<br> - Patients unable to give informed consent.
<br> | | SARS-CoV 2 Infection;Covid19 | Biological: BBIBP-CorV;Biological: BNT162b2 | Change from Baseline Immunogenicity at 8 weeks | | | | Yes | False | | |
| → | NCT05000216 | 1 November 2021→8 November 2021 | COVID-19 Booster Vaccine in Autoimmune Disease Non-Responders | Booster Effects With Autoimmune Treatments in Patients With Poor Response to Initial COVID-19 Vaccine (ACV01) | | National Institute of Allergy and Infectious Diseases (NIAID) | 06/08/2021 | 20210806 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05000216 | Recruiting | No | 18 Years | N/A | All | August 13, 2021 | 600 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 2 | United States | ; ; ; | Judith A. James, MD, PhD;Meggan C. Mackay, MD, MS;Dinesh Khanna, MBBS, MSc;Amit Bar-Or, MD, FRCP | | ;;; | ;;; | Arthritis and Clinical Immunology Program, Oklahoma Medical Research Foundation;Center of Autoimmune Musculoskeletal and Hematopoietic Diseases, Feinstein Institute for Medical Research;University of Michigan Health, Michigan Medicine;Center for Neuroinflammation and Neurotherapeutics, Perelman School of Medicine, University of Pennsylvania |
<br> Inclusion Criteria:
<br>
<br> Individuals who meet all the following criteria are eligible for enrollment as study
<br> participants-
<br>
<br> 1. Individuals that meet classification criteria for:
<br>
<br> - systemic lupus erythematosus (SLE)
<br>
<br> - systemic sclerosis (SSc)
<br>
<br> - rheumatoid arthritis (RA)
<br>
<br> - multiple sclerosis (MS), or
<br>
<br> - pemphigus
<br>
<br> 2. Participants must meet:
<br>
<br> - the 2019 American College of Rheumatology/European League Against Rheumatism
<br> (ACR/EULAR) or the 2012 Systemic Lupus International Collaborating Clinics
<br> Classification Criteria (SLICC) classification criteria for SLE
<br>
<br> - the 2010 ACR/EULAR classification criteria for RA
<br>
<br> - the 2013 EULAR/ACR classification criteria for SSc
<br>
<br> - the 2017 McDonald criteria for MS, and
<br>
<br> - the international consensus criteria for pemphigus
<br>
<br> Note: If a participant has been diagnosed with more than one autoimmune disease, the
<br> participant will be assessed based on the disease that is selected for study entry
<br>
<br> 3. Willing and able to sign informed consent
<br>
<br> 4. Documented full COVID-19 vaccination (e.g., Centers for Disease Control and Prevention
<br> [CDC] vaccination card or documentation in medical records) that was completed = 4
<br> weeks prior and no more than 36 weeks prior to the Screening visit
<br>
<br> 5. Negative serologic or suboptimal response to initial COVID-19 vaccine regimen- defined
<br> as an Elecsys® Anti-Severe Acute Respiratory Syndrome Coronavirus-2
<br> (anti-SARS-CoV-2-spike (S) protein receptor binding domain (RBD)) result = 50 U/mL at
<br> Screening visit
<br>
<br> -Initial COVID-19 vaccine regimen is defined as either:
<br>
<br> - 2 doses of the Pfizer-BioNTech COVID-19 vaccine
<br>
<br> - 2 doses of the Moderna COVID-19 vaccine, or
<br>
<br> - A single dose of the Janssen COVID-19 vaccine
<br>
<br> 6. Must be currently taking one of the following immunosuppressive medications with or
<br> without additional disease related medications:
<br>
<br> - mycophenolate mofetil (minimum of 1,000 mg per day)/mycophenolic acid (minimum of
<br> 720 mg per day)
<br>
<br> - methotrexate (minimum of 7.5mg per week), or
<br>
<br> - B cell depleting agents within the past 12 months (such as rituximab,
<br> ocrelizumab, ofatumumab)
<br>
<br> - If taking mycophenolate mofetil (MMF)/mycophenolic acid (MPA) or
<br> methotrexate (MTX), the participant should have initiated therapy at least 8
<br> weeks prior to randomization and be taking the same medications (regardless
<br> of dose) as at the time of the initial COVID-19 vaccine regimen
<br>
<br> - Participants on B cell depleting therapy may enter the study if they are
<br> also taking MMF/MPA or MTX. In this case, the MMF/MPA or MTX would not be
<br> withheld for the vaccine booster dose(s)
<br>
<br> - Participants taking both MMF/MPA and MTX will be excluded from the study
<br>
<br> 7. No changes in background immunosuppressive medications in the 8 weeks prior to
<br> Screening, excluding the following:
<br>
<br> - hydroxychloroquine (HCQ)
<br>
<br> - Intraarticular steroids
<br>
<br> - The addition of prednisone at =10 mg per day or prednisone at any dose when given
<br> for = 3 days, and
<br>
<br> - Corticosteroid bursts for non-autoimmune disease-related conditions, such as
<br> asthma or chronic obstructive pulmonary disease (COPD), are permitted
<br>
<br> Exclusion Criteria:
<br>
<br> Individuals who meet any of these criteria are not eligible for enrollment as study
<br> participants-
<br>
<br> 1. Inability or unwillingness of a participant to give written informed consent or comply
<br> with study protocol
<br>
<br> 2. History of severe allergic reaction to the initial COVID-19 vaccine regimen, or any
<br> component of any of the COVID-19 vaccines, or to polyethylene glycol (PEG)
<br>
<br> 3. Ongoing treatment for a malignancy with chemotherapy or immunotherapy
<br>
<br> 4. Active disease (per the Investigator's decision) resulting in inability to hold the
<br> immunosuppressive therapy in the Mycophenolate Mofetil (MMF)/Mycophenolic Acid (MPA)
<br> or Methotrexate (MTX) arms of the study
<br>
<br> The potential impact of temporarily holding medication for participants with a recent
<br> mild disease flare within 4 weeks should be carefully considered
<br>
<br> 5. Active disease during the Screening period resulting in:
<br>
<br> - an increase/addition of immunosuppressive medications, or
<br>
<br> - a suggestion of multiple sclerosis (MS) relapse per the investigator
<br>
<br> 6. Recent or current Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
<br> infection defined as:
<br>
<br> - Documented SARS-CoV-2 infection in the past 30 days (from the day the participant
<br> is diagnosed by positive test to Screening), or
<br>
<br> - A positive result on a molecular COVID-19 test at Screening
<br>
<br> 7. Receipt of a COVID-19 vaccine booster prior to Screening with the Moderna COVID-19
<br> vaccine, Pfizer-BioNTech COVID-19 vaccine, or Janssen COVID-19 vaccine
<br>
<br> 8. Participants with:
<br>
<br> - a history of autoimmune disease-related myocarditis within 3 years
<br>
<br> - autoimmune disease-related pericarditis within the past year, or
<br>
<br> - inflammatory myocarditis/pericarditis following initial COVID-19 vaccine regimen
<br>
<br> 9. Participants with active bacterial or viral infections who have received antibiotics
<br> within the 14 days prior to Screening, including participants with evidence of:
<br>
<br> - Human Immunodeficiency Virus (HIV)
<br>
<br> - Hepatitis B as indicated by surface antigen or hepatitis B core antibody
<br> positivity
<br>
<br> - Hepatitis C as indicated by anti-hepatitis C antibody positivity
<br>
<br> - Note: If a participant is Hepatitis C antibody positive, they will be
<br> eligible to participate in the study if he/she is negative for viral load at
<br> Screening
<br>
<br> 10. Participants with common variable immunodeficiency disease, as well as any
<br> participants currently receiving immune globulin replacement therapy
<br>
<br> 11. Participants who received licensed or investigational monoclonal antibodies or plasma
<br> products directed against SARS-CoV-2 within 90 days of Screening
<br>
<br> 12. Participants who have received any live vaccines within 2 months of the anticipated
<br> study vaccine dose or who will have need of a live vaccine at any time during the
<br> study
<br>
<br> 13. Participants with history of arterial or venous thrombosis, and/or history of
<br> recurrent miscarriages associated with clotting antibodies (anticardiolip | | Rheumatoid Arthritis;Systemic Lupus Erythematosus (SLE);Pemphigus Vulgaris;Multiple Sclerosis;Systemic Sclerosis (SSc) | Biological: Moderna mRNA-1273;Biological: BNT162b2;Biological: Ad26.COV2.S;Drug: IS (MMF or MPA);Drug: IS (MTX);Biological: IS (B cell depletion therapy) | Proportion of participants who have a protective antibody response at Week 4 | | | | Yes | False | | |
| → | NCT05012267 | 1 November 2021→8 November 2021 | Duration of Prone Position in the Severe Acute Respiratory Syndrome Coronavirus 2 (COVID-19). | OptiMal pronE Position LEnghT in Patients With acuTE Respiratory Distress Syndrome Due to COVID-19. | OmeLEtte | Ignacio Saez de la Fuente | 11/08/2021 | 20210811 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05012267 | Not recruiting | No | 18 Years | N/A | All | March 25, 2021 | 61 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Spain | | Ignacio Sáez, MD | | | | Hospital Universitario 12 de Octubre |
<br> Inclusion Criteria:
<br>
<br> - Patient above 18 year-old.
<br>
<br> - Diagnosis of severe ARDS due to COVID-19 under invasive mechanical ventilation,
<br>
<br> - Meet criteria for PP: PaO2/FiO2 < 150 millimeters of mercury column (mmHg), PEEP = 5
<br> Centimeters of Water (cmH2O), FiO2 = 60.
<br>
<br> Exclusion Criteria:
<br>
<br> - No consent for the study.
<br>
<br> - PP contraindicated (( elevated intracranial pressure, massive hemoptysis, recent
<br> tracheal surgery or sternotomy, unstable hemodynamic status, recent pacemaker
<br> implantation, severe facial laceration, open abdominal wound, spine, femur or pelvis
<br> fracture or pregnancy).
<br> | | Ards | Other: 16-hour PP | Ventilator-free days at 60 days;Ventilator-free days at 28 days | | | | Yes | False | | |
| → | NCT05024474 | 7 September 2021→8 November 2021 | Effects of Inspiratory Muscle Training After Covid-19 (ReCOV) | Effects of Inspiratory Muscle Training After Covid-19 | IMT-ReCov | Karolinska Institutet | 24/08/2021 | 20210824 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05024474 | Recruiting | No | 18 Years | N/A | All | August 24, 2021 | 90 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | N/A | Sweden | ; ; | Malin Nygren Bonnier, PhD;Malin Nygren Bonnier, PhD;Malin Nygren-Bonnier, PhD | | ;malin.nygren-bonnier@ki.se;malin.nygren-bonnier@ki.se | ;+4685248831; | Karolinska Institutet; |
<br> Inclusion Criteria:
<br>
<br> - Adult patients (=18 years) who have undergone Covid-19 and have 80% or less of the
<br> lower limit of predicted value in maximal inspiratory pressure (MIP).
<br>
<br> Exclusion Criteria:
<br>
<br> - Physical och cognitive dysfunction which makes it impossible to carry out measurements
<br> and interventions. Already on-going intervention with inspiratory muscle training.
<br> | | Covid-19;Respiratory Complication;Post-Acute Covid-19 Syndrome | Other: Inspiratory muscle training (IMT);Other: Physical exercise | Change in Maximal Inspiratory Pressure (MIP) | | | | Yes | False | | |
| → | NCT05026801 | 1 November 2021→8 November 2021 | Azithromycin Plus Hydroxychloroquine for COVID-19 Infection | A Randomized, Double-blinded Phase 3 Multi-center Study of the Clinical and Microbiologic Efficacy of a Combination of Azithromycin and Hydroxychloroquine for Treatment of COVID-19 Infection | | Iterum Therapeutics, International Limited | 08/02/2021 | 20210208 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05026801 | Not recruiting | No | 18 Years | N/A | All | February 8, 2021 | 0 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | United States | | Michael Dunne, MD | | | | Iterum Therapeutics |
<br> Inclusion Criteria:
<br>
<br> 1. Adults =18 years of age
<br>
<br> 2. History of a respiratory tract infection (RTI) for more than one but less than six
<br> days including two or more of the following signs and symptoms of an RTI:
<br>
<br> • Fever (T = 38.0 C, 100.5 F), cough, sputum production, arthralgia/myalgia,
<br> anosmia/ageusia or difficulty breathing.
<br>
<br> 3. A nasal or throat swab or nasal wash positive by PCR for SARS-CoV-2.
<br>
<br> 4. Has given written informed consent to participate in the study. Due to the public
<br> health issues related to this viral infection, witnessed informed consent may be
<br> obtained remotely.
<br>
<br> Exclusion Criteria:
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients likely, in the opinion of the investigator, to require hospitalization within
<br> 48 hours of randomization into the study.
<br>
<br> 2. Concurrent use of non-study antibacterial drug therapy that would have a potential
<br> effect on outcome evaluations in patients with an RTI
<br>
<br> 3. Concurrent use of any other medications for the purpose of treating a viral infection
<br> such as influenza antivirals
<br>
<br> 4. Inability to swallow oral medication in tablet form
<br>
<br> 5. Patient has severe chronic kidney disease, or is receiving hemodialysis, or peritoneal
<br> dialysis or had a renal transplant
<br>
<br> 6. Patient is known to have severe neutropenia
<br>
<br> 7. Patients with a known prolongation of the QT interval or are taking medications which
<br> could prolong the QT interval
<br>
<br> 8. Patient is known to be pregnant
<br>
<br> 9. Patients with a known history of myasthenia gravis
<br>
<br> 10. Patients with a history of allergy to azithromycin, hydroxychloroquine or chloroquine
<br>
<br> 11. Patient is considered unlikely to survive the study period or has a rapidly
<br> progressive or terminal illness, including septic shock, associated with a high risk
<br> of mortality
<br> | | Respiratory Tract Infection Viral | Drug: Azithromycin plus hydroxychloroquine | Microbiologic response | | | | Yes | False | | |
| → | NCT05028361 | 26 October 2021→8 November 2021 | Simultaneous mRNA COVID-19 and IIV4 Vaccination Study | Safety of Simultaneous Versus Sequential Administration of mRNA COVID-19 Vaccines and Quadrivalent Inactivated Influenza (IIV4) in Adults and Adolescents: A Randomized Observer Blinded Study→Safety of Simultaneous Versus Sequential Administration of mRNA COVID-19 Vaccines and Quadrivalent Inactivated Influenza Vaccine (IIV4) in Adults and Adolescents: A Randomized Observer Blinded Study | | Duke University | 30/08/2021 | 20210830 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05028361 | Recruiting | No | 12 Years | N/A | All | October 4, 2021 | 450 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Outcomes Assessor). | Phase 4 | United States | ; ; ; ; | Emmanual B Walter, MD, MPH;Karen R Broder, MD;Kawsar Talaat, MD;Elizabeth Schlaudecker, MD, MPH;Emmanual B Walter, MD, MPH | | ;;;;chip.walter@duke.edu | ;;;;919-620-5346 | Duke University;Centers for Disease Control and Prevention;Johns Hopkins University;Children's Hospital Medical Center, Cincinnati; |
<br> Inclusion Criteria:
<br>
<br> - Persons aged =12 years
<br>
<br> - English or Spanish literate
<br>
<br> - Intention of receiving influenza vaccine and COVID-19 vaccine based on ACIP-CDC
<br> guidelines
<br>
<br> - Willing to provide written informed consent
<br>
<br> - Intention of being available for entire study period and complete all relevant study
<br> procedures, including follow-up phone calls and clinic visits
<br>
<br> Exclusion Criteria:
<br>
<br> - Currently pregnant, planning to become pregnant within the first three months of the
<br> study per participant self-report or likely to be pregnant per screening criteria as
<br> defined in Section 5.1 at Visit 1
<br>
<br> - Prior receipt of IIV4 during the 2021-2022 influenza season
<br>
<br> - Prior receipt of a COVID-19 vaccine. Note: receipt of an mRNA COVID-19 vaccine within
<br> 8 hours of enrollment is permitted.
<br>
<br> - Documented COVID-19 infection within 6 weeks prior to enrollment confirmed by either
<br> medical history or lab testing
<br>
<br> - History of severe allergic reaction after a previous dose of any influenza vaccine; or
<br> to an influenza vaccine component, including egg protein
<br>
<br> - History of severe adverse reaction associated with a vaccine and/or severe allergic
<br> reaction (e.g. anaphylaxis) to any component of an mRNA vaccine
<br>
<br> - Receipt of any licensed inactivated vaccine within 2 weeks prior to enrollment in this
<br> study, receipt of any licensed live vaccine within 4 weeks prior to enrollment in this
<br> study, or receipt of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) or HEPLISAV-B
<br> (Hepatitis B Vaccine (Recombinant), Adjuvanted) vaccine within 6 weeks prior to
<br> enrollment in this study or planning receipt of any vaccines following enrollment
<br> until 6 weeks after receipt of the second dose of mRNA COVID-19 vaccine
<br>
<br> - Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate
<br> cancer that is stable in the absence of therapy) or a history of any hematologic
<br> malignancy*
<br>
<br> *Participants with a history of malignancy may be included if, after previous
<br> treatment by surgical excision, chemotherapy or radiation therapy, the participant has
<br> been observed for a period that in the investigator's estimation provides a reasonable
<br> assurance of sustained cure
<br>
<br> - Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating
<br> intramuscular injection (a daily aspirin may be acceptable).
<br>
<br> - Has immunosuppression as a result of an underlying illness or medications, such as
<br> antirejection/transplant regimens or immunomodulatory agents. Stable HIV disease is
<br> permitted per the following parameters:
<br>
<br> a. Confirmed stable HIV disease defined as document viral load <50 copies/mL and CD4
<br> count >200 within 6 months before enrollment, and on stable antiretroviral therapy for
<br> at least 6 months
<br>
<br> - Has known hepatitis B (HBV) or hepatitis C (HBC). Stable HBV or HBC are permitted per
<br> the following parameters:
<br>
<br> 1. If known HBV: confirmed inactive chronic HBV infection: HBsAg present for =6
<br> months and HBeAg negative, anti-HBe positive; serum HBV DNA <2000 IU/mL;
<br> persistently normal ALT or AST levels; in those who had liver biopsy, findings
<br> that confirm absence of significant necroinflammation
<br>
<br> 2. If known HCV: evidence of sustained virological response for =12 weeks after
<br> treatment or without evidence of HCV RNA viremia (undetectable HCV RNA)
<br>
<br> - Use of oral, parenteral, or high-dose inhaled glucocorticoids
<br>
<br> *For definition of high-dose inhaled glucocorticoids, reference Appendix B.
<br>
<br> - History of Guillain-Barré syndrome
<br>
<br> - Anyone who is already enrolled or plans to enroll in another clinical trial with an
<br> investigational product within 28 days of vaccine receipt.*
<br>
<br> *Per protocol, co-enrollment in observational or behavioral intervention studies are
<br> permitted at any time, while enrollment in a clinical trial involving an
<br> investigational product will not be permitted following enrollment until 4 weeks after
<br> receipt of the second dose of mRNA COVID-19 vaccine. An investigational product may be
<br> permitted for therapy of an illness condition that occurs during the study period e.g.
<br> COVID-19 illness.
<br>
<br> - Hearing loss determined by the investigators to prevent successful communication over
<br> the phone
<br>
<br> - History of myocarditis or pericarditis
<br>
<br> - History of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A).
<br>
<br> - Has injury or other reason why deltoid site on both arms cannot be used for
<br> vaccinations.
<br>
<br> - Any condition which, in the opinion of the investigators, may pose a health risk to
<br> the subject or interfere with the evaluation of the study objectives.
<br>
<br> - Anyone who is a relative of any research study personnel.
<br>
<br> - Anyone who is an employee of any research study personnel.
<br> →
<br> Inclusion Criteria:
<br>
<br> - Persons aged =12 years if receiving primary two-dose mRNA COVID-19 vaccine series or
<br> persons aged =18 years if receiving a third mRNA COVID-19 vaccine dose according to
<br> FDA authorization or approval and ACIP recommendation. Note: receipt of an mRNA
<br> COVID-19 vaccine within 8 hours of enrollment is permitted
<br>
<br> - English or Spanish literate
<br>
<br> - Intention of receiving influenza vaccine and COVID-19 vaccine based on ACIP-CDC
<br> guidelines
<br>
<br> - Willing to provide written informed consent
<br>
<br> - Intention of being available for entire study period and complete all relevant study
<br> procedures, including follow-up phone calls and clinic visits
<br>
<br> Exclusion Criteria:
<br>
<br> - Currently pregnant, planning to become pregnant within the first three months of the
<br> study per participant self-report or likely to be pregnant per screening criteria as
<br> defined in Section 5.1 at Visit 1
<br>
<br> - Prior receipt of IIV4 during the 2021-2022 influenza season
<br>
<br> - Prior receipt of non-mRNA COVID-19 vaccine
<br>
<br> - Prior receipt of more than 2 mRNA COVID-19 vaccines
<br>
<br> - Documented COVID-19 infection within 6 weeks prior to enrollment confirmed by either
<br> medical history or lab testing
<br>
<br> - History of severe allergic reaction after a previous dose of any influenza vaccine; or
<br> to an influenza vaccine component, including egg protein
<br>
<br> - History of severe adverse reaction associated with a vaccine and/or severe allergic
<br> reaction (e.g. anaphylaxis) to any component of an mRNA vaccine
<br>
<br> - Receipt of any licensed inactivated vaccine within 2 weeks prior to enrollment in this
<br> study, receipt of any licensed live vaccine within 4 weeks prior to enrollment in this
<br> study, or receipt of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) or HEPLISAV-B
<br> (Hepatitis B Vaccine (Recombinant), Adjuvanted) vaccine within 6 weeks prior to
<br> enrollment in this study or planning receipt of any vaccines following enrollment
<br> until 6 weeks after receipt of the second dose of mRNA COVID-19 vaccine
<br>
<br> - Has an active neoplastic disease (excluding non-melanoma skin cancer or prostate
<br> cancer that is stable in the absence of therapy) or a history of any hematologic
<br> malignancy*
<br>
<br> *Participants with a history of malignancy may be included if, after previous
<br> treatment by surgical excision, chemotherapy or radiation therapy, the participant has
<br> been observed for a period that in the investigator's estimation provides a reasonable
<br> assurance of sustained cure
<br>
<br> - Thrombocytopenia, bleeding disorder, or anticoagulant use contraindicating
<br> intramuscular injection (a daily aspirin may be acceptable).
<br>
<br> - Has immunosuppression as a result of an underlying illness or medications, such as
<br> antirejection/transplant regimens or immunomodulatory agents. Stable HIV disease is
<br> permitted per the following parameters:
<br>
<br> a. Confirmed stable HIV disease defined as document viral load <50 copies/mL and CD4
<br> count >200 within 6 months before enrollment, and on stable antiretroviral therapy for
<br> at least 6 months
<br>
<br> - Has known hepatitis B (HBV) or hepatitis C (HBC). Stable HBV or HBC are permitted per
<br> the following parameters:
<br>
<br> 1. If known HBV: confirmed inactive chronic HBV infection: HBsAg present for =6
<br> months and HBeAg negative, anti-HBe positive; serum HBV DNA <2000 IU/mL;
<br> persistently normal ALT or AST levels; in those who had liver biopsy, findings
<br> that confirm absence of significant necroinflammation
<br>
<br> 2. If known HCV: evidence of sustained virological response for =12 weeks after
<br> treatment or without evidence of HCV RNA viremia (undetectable HCV RNA)
<br>
<br> - Use of oral, parenteral, or high-dose inhaled glucocorticoids
<br>
<br> *For definition of high-dose inhaled glucocorticoids, reference Appendix B.
<br>
<br> - History of Guillain-Barré syndrome
<br>
<br> - Anyone who is already enrolled or plans to enroll in another clinical trial with an
<br> investigational product during the study period.*
<br>
<br> *Per protocol, co-enrollment in observational or behavioral intervention studies are
<br> permitted at any time. An investigational product may be permitted for therapy of an
<br> illness condition that occurs during the study period e.g. COVID-19 illness.
<br>
<br> - Hearing loss determined by the investigators to prevent successful communication over
<br> the phone
<br>
<br> - History of myocarditis or pericarditis
<br>
<br> - History of multisystem inflammatory syndrome in children (MIS-C) or adults (MIS-A).
<br>
<br> - Has injury or other reason why deltoid site on both arms cannot be used for
<br> vaccinations.
<br>
<br> - Any condition which, in the opinion of the investigators, may pose a health risk to
<br> the subject or interfere with the evaluation of the study objectives.
<br>
<br> - Anyone who is a relative of any research study personnel.
<br>
<br> - Anyone who is an employee of any research study personnel.
<br> | | Pain;Quality of Life;Injection Site Reaction;Adverse Drug Event | Biological: Simultaneous administration of mRNA COVID-19 and IIV4→Biological: mRNA COVID-19;Biological: IIV4;Other: Placebo | Number of participants with moderate or more severe fever, chills, myalgia, or arthralgia in the Simultaneous Group and the Sequential Group following both Vaccination Visit 1 and 2 | | | | Yes | False | | |
| → | NCT05031988 | 20 September 2021→8 November 2021 | Determinants of Physical Activity and Mental Health During Covid-19→Determinants of Physical Activity and Mental Health During and After Covid-19 Lockdown | Determinants of Physical Activity and Mental Health During Covid-19 Movement Restriction Order Among University Students→Determinants of Physical Activity and Mental Health During and After Covid-19 Lockdown Among University Students | | Universiti Tunku Abdul Rahman | 01/09/2021 | 20210901 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05031988 | Not recruiting→Recruiting | No | 18 Years | 25 Years | All | October 11, 2021→October 18, 2021 | 414 | Observational | | | →Malaysia | → ; | →Imtiyaz Ali Mir;Shang Kuan Ng Mir | | →imtiyaz2204@yahoo.com; | →+60108040342; | |
<br> Inclusion Criteria:
<br>
<br> - Undergraduate students studying in Universiti Tunku Abdul Rahman, aged 18-25 years and
<br> are willing to participate in this study.
<br>
<br> Exclusion Criteria:
<br>
<br> - Students diagnosed with depression/anxiety or high stress before the implementation of
<br> movement control order.
<br> | | University Students | Other: No intervention will be used. | Stress;Anxiety;Depression;Physical Activity Level→Anxiety;Depression;Physical Activity Level | | | | Yes | False | | |
| → | NCT05047640 | 27 September 2021→8 November 2021 | COVID-19 3rd Dose Vaccine in Transplant Patients | A Single-Blind, Randomized, Controlled Trial Comparing BNT162b2 vs JNJ-78436735 Vaccine as a Booster Dose After Completion of BNT162b2 Vaccine in Solid Organ Transplant Recipients | | Giselle Guerra | 13/09/2021 | 20210913 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05047640 | Not recruiting→Recruiting | No | 18 Years | N/A | All | September 9, 2021→September 14, 2021 | 200 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant). | Phase 3 | United States | ; ; | Giselle Guerra, MD;Giselle Guerra, MD;Giselle Guerra, MD | | ;gguerra@med.miami.edu;gguerra@med.miami.edu | ;3053555803;305-355-5803 | University of Miami; |
<br> Inclusion Criteria:
<br>
<br> - Patients 18 years of age and older
<br>
<br> - Patients who had received a solid organ (kidney, liver, lung, heart, and pancreas)
<br> transplant patient from living or deceased donors.
<br>
<br> - Patients with active graft with at least one immunosuppressive medication
<br>
<br> - Completed two doses of BNT162b2 vaccination at least 28 days ago
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient with non-active graft
<br>
<br> - Any significant side effect with previous COVID-19 vaccination
<br>
<br> - Within 28 days of BNT162b2 vaccine completion
<br>
<br> - Already received more than and equal to three doses of COVID-19 vaccination
<br>
<br> - Previously received COVID-19 vaccine other than BNT162b2 vaccine
<br>
<br> - Previous history of lab confirmed SARS-CoV-2 infection
<br>
<br> - History of chronic thrombocytopenia
<br>
<br> - History of Capillary Leak Syndrome
<br>
<br> - Adults unable to consent
<br>
<br> - Individuals who are not yet adults (younger than 18 year old)
<br>
<br> - Vulnerable patients (prisoners)
<br>
<br> - Pregnant women
<br> →
<br> Inclusion Criteria:
<br>
<br> - Patients 18 years of age and older
<br>
<br> - Patients who had received a solid organ (kidney, liver, lung, heart, and pancreas)
<br> transplant patient from living or deceased donors.
<br>
<br> - Patients with active graft with at least one immunosuppressive medication
<br>
<br> - Completed two doses of BNT162b2 vaccination at least 28 days ago
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient with non-active graft
<br>
<br> - Any significant side effect with previous COVID-19 vaccination
<br>
<br> - Within 28 days of BNT162b2 vaccine completion
<br>
<br> - Already received more than and equal to three doses of COVID-19 vaccination
<br>
<br> - Previously received COVID-19 vaccine other than BNT162b2 vaccine
<br>
<br> - Previously received monoclonal Antibody treatment
<br>
<br> - History of chronic thrombocytopenia
<br>
<br> - History of Capillary Leak Syndrome
<br>
<br> - Adults unable to consent
<br>
<br> - Individuals who are not yet adults (younger than 18 year old)
<br>
<br> - Vulnerable patients (prisoners)
<br>
<br> - Pregnant women
<br> | | Covid19 | Biological: BNT162b2 vaccine;Biological: JNJ-78436735 Vaccine | Anti-spike protein of SARS-CoV-2 virus IgG positive rate | | | | Yes | False | | |
| → | NCT05049200 | 27 September 2021→8 November 2021 | Characteristics of Weaning From Mechanical Ventilation in COVID-19 | Epidemiology of Weaning From Invasive Mechanical Ventilation in COVID-19. Observational and Multicenter Study. | CovWean | Sanatorio Anchorena San Martin | 16/09/2021 | 20210916 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05049200 | Not recruiting | No | 18 Years | N/A | All | April 1, 2020 | 326 | Observational [Patient Registry] | | | Argentina | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Diagnosis of COVID-19 by PCR +
<br>
<br> - Invasive mechanical ventilation for more than 12 hours
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects admitted to pediatric ICUs and surgery recovery room.
<br>
<br> - Patients who were readmitted and required a new cycle of invasive mechanical
<br> ventilation after having been successfully weaned and released from the hospital.
<br> | | Respiration, Artificial;COVID-19 | | weaning classification;weaning rate→weaning rate;weaning classification | | | | No | False | | |
| → | NCT05052580 | 4 October 2021→8 November 2021 | Test to Stay in School: COVID-19 Testing Following Exposure in School Communities | Test to Stay in School: COVID-19 Testing Following Exposure in School Communities | | Duke University | 20/09/2021 | 20210920 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05052580 | Not recruiting→Recruiting | No | N/A | N/A | All | September 27, 2021→October 1, 2021 | 1000000 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). | N/A | →United States | ; → | Kanecia Zimmerman, MD, MPH;Tara Mann, PhD, RN→Kanecia Zimmerman, MD, MPH | | ;SchoolSETStudy@duke.edu→ | ;919-668-5111→ | Duke University;→Duke University |
<br> Inclusion Criteria:
<br>
<br> - Consent completed
<br>
<br> - Child or adult that is part of a school community
<br>
<br> - Known exposure to SARS-CoV-2 in the school setting (e.g. school bus, classroom, school
<br> sporting event, etc.)
<br>
<br> Exclusion Criteria:
<br>
<br> - None
<br> | | Covid19 | Other: COVID-19 Testing | Number of students with positive COVID-19 test following known within-school exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a COVID-19 test.;Number of staff with positive COVID-19 tests following known within-school exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a COVID-19 test.;Number of exposures (as measured by nurse report) undergoing the test-to-stay protocol that result in additional transmission, reported as a proportion (%) of the total number of participants enrolled in the study.;Time (in days) to test positivity (reported as a mean) among those exposed to SARS-CoV-2 and undergoing the test-to-stay protocol.→Time (in days) to test positivity (reported as a mean) among those exposed to SARS-CoV-2 and undergoing the test-to-stay protocol.;Number of exposures (as measured by nurse report) undergoing the test-to-stay protocol that result in additional transmission, reported as a proportion (%) of the total number of participants enrolled in the study.;Number of staff with positive COVID-19 tests following known within-school exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a COVID-19 test.;Number of students with positive COVID-19 test following known within-school exposure, reported as a proportion (%) of the total number of participants enrolled in the study, and measured by a COVID-19 test. | | | | Yes | False | | |
| → | NCT05054127 | 4 October 2021→8 November 2021 | Clinical Characteristics And Outcome Of COVID-19 Infection In Patients With Chronic Respiratory Diseases. | Clinical Characteristics And Outcome Of COVID-19 Infection In Patients With Chronic Respiratory Diseases. | | Assiut University | 21/09/2021 | 20210921 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05054127 | Not recruiting | No | 18 Years | 80 Years | All | September 15, 2021→December 15, 2021 | 100 | Observational [Patient Registry] | | | | | Reham El Morshedy, lecturer | | reham1715@gmail.com | 01065060672 | |
<br> Inclusion Criteria:
<br>
<br> 1. patients with chronic respiratory diseases diagnosed with covid-19 infection by PCR
<br>
<br> 2. Patients aged 18 years and above
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patient aged below 18 years old.
<br>
<br> 2. Patients refuse to share in our study
<br> | | Covid19;Chronic Respiratory Disease | Other: foiiow up patients | relation between covid 19 and patients with chronic respiratory diseases | | | | Yes | False | | |
| → | NCT05054218 | 4 October 2021→8 November 2021 | COVID-19 Immunogenicity of a Third Dose of mRNA-1273 Vaccine Among Cancer Patients | Immunogenicity of a Third Dose of mRNA-1273 Vaccine (Moderna) Among Cancer Patients | | H. Lee Moffitt Cancer Center and Research Institute | 14/09/2021 | 20210914 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05054218 | Recruiting | No | 18 Years | N/A | All | September 10, 2021 | 400 | Observational | | | United States | ; ; | Anna Giuliano, PhD;Martha Abrahamsen;Martha Abrahamsen | | ;Martha.Abahamsen@moffitt.org;Martha.Abrahamsen@moffitt.org | ;813-745-6055;813-745-6055 | Moffitt Cancer Center; |
<br> Inclusion Criteria:
<br>
<br> - Patients of Moffitt Cancer Center
<br>
<br> - English or Spanish speaking
<br>
<br> - Participants who received their 1st Moderna COVID vaccine at Moffitt Cancer Center
<br> starting on January 12, 2021
<br>
<br> - Agree to pre- or post-vaccination blood draws under the TCC protocol
<br>
<br> Exclusion Criteria:
<br>
<br> - Participants who will not return for the third vaccine dose
<br> →
<br> Inclusion Criteria:
<br>
<br> - At least 18 years of age
<br>
<br> - Is a cancer patient enrolled in the Cancer Patient Immune Response to COVID-19 Vaccine
<br> study (a basic science study) MCC 21138 or who has completed the two mRNA-1273 vaccine
<br> series prior to March 31, 2021.
<br>
<br> - Understands, agrees and is able to comply with the study procedures and provides
<br> written informed consent.
<br>
<br> - Has no known or suspected allergy or history of anaphylaxis, urticaria, or other
<br> significant adverse reactions to the vaccine or its excipients.
<br>
<br> - Has not received more or less than 2 doses of mRNA-1273 vaccine
<br>
<br> Exclusion Criteria:
<br>
<br> - Participants who will not return for the third vaccine dose
<br> | | Covid19;SARS-CoV2 Infection | Biological: mRNA-1273 | 1. The level of anti-SARS-CoV-2 Spike (S)-specific neutralizing antibody (nAb) 28 days post-dose 3;Anti-SARS-CoV-2 Spike (S)-specific neutralizing antibody (nAb) 6 months post-dose 3;Anti-SARS-CoV-2 Spike (S)-GMT Ab 28 days post-dose 3;Anti-SARS-CoV-2 Spike (S)-GMT Ab 6 months post-dose 3;Level antibodies that block the binding of ACE2 to RBD antigens from 10 SARS-CoV-2 variants of concern 28 days post-dose 3;Level antibodies that block the binding of ACE2 to RBD antigens from 10 SARS-CoV-2 variants of concern 6 months post-dose 3 | | | | Yes | False | | |
| → | NCT05057169 | 11 October 2021→8 November 2021 | Randomized Trial of COVID-19 Booster Vaccinations (Cobovax Study) | Randomized Trial of COVID-19 Booster Vaccinations (Cobovax Study) | | The University of Hong Kong | 24/09/2021 | 20210924 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05057169 | Not recruiting | No | 18 Years | N/A | All | October 5, 2021→November 18, 2021 | 400 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor). | Phase 4 | Hong Kong | ; | Benjamin J Cowling, PhD;Benjamin J Cowling, PhD | | ;bcowling@hku.hk | ;+85239176711 | The University of Hong Kong; |
<br> Inclusion Criteria:
<br>
<br> - Aged 18 years or older at enrolment.
<br>
<br> - Have received two doses of BNT162b2 OR two doses of CoronaVac, with the most recent
<br> dose at least six months prior to enrolment.
<br>
<br> - Currently resident and planning to remain resident in Hong Kong during the duration of
<br> the study, i.e. for 12 months after enrolment.
<br>
<br> - Agreement to refrain from blood donation during the course of the study.
<br>
<br> - Willing to provide blood samples for all the required time points.
<br>
<br> - The individual or their caregiver have a home phone or cellular or mobile phone for
<br> communications purpose.
<br>
<br> - Capable of providing informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - A history of laboratory-confirmed or clinically confirmed COVID-19 infection prior to
<br> enrolment.
<br>
<br> - Have previously already received one or two doses of any COVID-19 vaccines except
<br> CoronaVac or BNT162b2, for example but not limited to BBIBP-CorV (inactivated vaccine,
<br> Sinopharm), AZD1222 (adenovirus vector-based vaccine, Oxford/AstraZeneca), Sputnik V
<br> (adenovirus vector-based vaccine, Gamaleya Research Institute) and Ad26.COV2.S
<br> (adenovirus vector-based vaccine, Johnson & Johnson).
<br>
<br> - Individuals who report any medical condition, or as determined by a clinician, not
<br> suitable to receive mRNA or inactivated COVID-19 vaccines, including but not limited
<br> to allergies to the active substance or other ingredients of the vaccine.
<br>
<br> - Currently with diagnosed medical conditions related to their immune system.
<br>
<br> - Use of medication that impairs immune system in the last 6 months, except topical
<br> steroids or short-term oral steroids (course lasting = 14 days).
<br>
<br> - Administration of immunoglobulins and/or any blood products within 90 days preceding
<br> the planned administration of the study vaccines.
<br>
<br> - Pregnancy, lactation or intention to become pregnant in the coming 3 months.
<br> | | COVID-19 Vaccination | Biological: BNT162b2;Biological: CoronaVac | Geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing antibodies | | | | Yes | False | | |
| → | NCT05062473 | 1 November 2021→8 November 2021 | Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem | Hypertension Control in the Age of COVID-19: Utilizing Telemedicine for Hypertension Treatment Lifestyle Modification in Central Harlem | | Weill Medical College of Cornell University | 02/09/2021 | 20210902 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05062473 | Recruiting | No | 18 Years | N/A | All | October 4, 2021 | 40 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | United States | ; ; | Tracy K Paul, MD;Dolores T Reynolds, BSN;Dolores T Reynolds, BSN | | ;dtr2001@med.cornell.edu;dtr2001@med.cornell.edu | ;2127464617;212-746-4617 | Weill Cornell Medicine/NY Presbyterian Hospital; |
<br> Inclusion Criteria:
<br>
<br> - Male or female greater than or equal to 18 years of age.
<br>
<br> - Self-report of a hypertension diagnosis.
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnant or breastfeeding.
<br>
<br> - End-stage renal disease on hemodialysis.
<br> | | Hypertension | Behavioral: Lifestyle Modification Webinars Focused on Hypertension Control | Change in Participant's Rate of Completion of Weekly Steps Recordings;Change in Participant's Rate of Completion of Weekly Blood Pressure Recordings;Change in Number of Participants Virtually Attending the Health Education Seminars;Participant's Satisfaction with the Curriculum at 12 Weeks | | | | Yes | False | | |
| → | NCT05069389 | 1 November 2021→8 November 2021 | Registry of Management Strategies for Patients With COVID-19 in Healthcare Establishments | Registry of Management Strategies for Patients With COVID-19 in Healthcare Establishments | HOPICOV | Centre Hospitalier Emile Roux | 30/09/2021 | 20210930 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05069389 | Recruiting | No | 18 Years | N/A | All | June 2, 2020 | 2071 | Observational | | | France | ; | Emilie GADEA-DESCHAMPS, PhD;Emilie GADEA-DESCHAMPS, PhD | | science.writer@ch-lepuy.fr;science.writer@ch-lepuy.fr | +33 4 71 04 35 38;+33 (0)4 71 04 35 38 | |
<br> Inclusion Criteria:
<br>
<br> - Any adult patient admitted to the establishment for treatment for a SARS-Cov2
<br> infection
<br>
<br> - Positive RT-PCR or a scanner suggestive of COVID-19 during the stay, or with a
<br> positive serology (even if carried out after the patient's discharge)
<br>
<br> - Hospitalization > 24h
<br>
<br> - Patients receiving any type of care, whether it is recommended standard care or
<br> off-label treatment as part of a therapeutic clinical trial or outside the scope of
<br> clinical research
<br>
<br> Exclusion Criteria:
<br>
<br> - Opposition to the use of data following written patient information
<br>
<br> - Patient transferred from another hospital to continue COVID care and whose initial
<br> care data is not available
<br> | | COVID-19 Infection | Other: Data collection | Describe management strategies implemented by healthcare establishments for patients with covid-19, depending on the evolution of scientific knowledge and recommendations for specific treatments. | | | | No | False | | |
| → | NCT05069623 | 1 November 2021→8 November 2021 | A Phase 1/2 Study to Determine Safety and Immunogenicity of Two COVID 19 Vaccines VB10.2129 (RBD Candidate) and VB10.2210 (T Cell Candidate) Previously Vaccinated in Healthy Adult Volunteers | A Phase 1/2, Open Label, Dose Escalation Study to Determine Safety and Immunogenicity of Two (Prophylactic) COVID 19 DNA Vaccine Candidates (VB10.2129 [C1], a RBD Candidate and VB10.2210 [C2], a T Cell Candidate), in Healthy Adult Volunteers | | Vaccibody AS | 04/10/2021 | 20211004 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05069623 | Recruiting | No | 18 Years | 60 Years | All | October 27, 2021 | 160 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1/Phase 2 | Norway | | Siri Torhaug, MD | | STorhaug@vaccibody.com | +47 95113393 | |
<br> Main inclusion criteria:
<br>
<br> - Give informed consent by signing the Informed Consent Form (ICF)
<br>
<br> - Part 1: have received 2 doses of an mRNA SARS-CoV-2 vaccine, minimum 6 months prior to
<br> Visit 1.
<br>
<br> - Part 2: have received full vaccination schedule of an approved SARS-CoV-2 vaccine,
<br> minimum 6 months prior to Visit 1.
<br>
<br> - Willing and able to comply with scheduled visits, treatment schedule, laboratory
<br> tests, lifestyle restrictions (eg, local law and regulations [county specific lock
<br> down rules] regarding COVID-19), and other requirements of the study.
<br>
<br> - Healthy, in the clinical judgement of the Investigator, based on medical history,
<br> physical examination, 12-lead electrocardiogram (ECG), vital signs (systolic/diastolic
<br> blood pressure, pulse rate, body temperature, respiratory rate), and clinical
<br> laboratory tests (blood chemistry, haematology, and urine chemistry) at Visit 0
<br> (Screening).
<br>
<br> - Women of childbearing potential (WOCBP) must have a negative pregnancy test and must
<br> agree to practice a highly effective form
<br>
<br> - Agree not to be vaccinated with any other vaccine during the study until 28 days after
<br> receiving the last study vaccination
<br>
<br> - Negative rtPCR-test for SARS-CoV-2
<br>
<br> Main exclusion criteria:
<br>
<br> - Have had any acute illness with or without fever, within 72 hours prior to the first
<br> vaccination
<br>
<br> - Symptoms of upper respiratory infection, fever, persistent cough, shortness of breath,
<br> runny nose and breathing difficulties
<br>
<br> - Breastfeeding or who plan to breastfeed during the study
<br>
<br> - Have a known allergy, hypersensitivity, or intolerance to aminoglycosides
<br>
<br> - Had any clinically significant or chronic medical condition or any major surgery
<br> within the past 5 years which
<br>
<br> - Have any surgery planned during the study
<br>
<br> - Had any chronic use of any systemic medications, including immunosuppressant's, oral
<br> corticosteroids or other immune-modifying drugs, within the 12 months prior to
<br> Screening
<br>
<br> - Received any vaccination within the 28 days prior to Screening
<br>
<br> - Received any prescription medicines (except hormonal contraception for WOCBP) within
<br> 14 days prior to Visit 0 (Screening) or over the counter medicines (except paracetamol
<br> and acetaminophen at a dose of (=2 grams/day)) within 48 hours of Visit 0.
<br>
<br> - Have a known history or a positive test of HIV 1 or 2, Hep B, or Hep C
<br>
<br> - Have a positive rtPCR test for SARS-CoV-2 within 2 days of Screening
<br>
<br> - Documented history of previous infection with SARS-CoV-2 and/or who have the presence
<br> of serum Ab indicative of a previous SARS-CoV-2 infection
<br>
<br> - Have a history of hypersensitivity or have had a serious reaction to a previous
<br> vaccination
<br>
<br> - Have any abnormality or permanent body art (eg, tattoo) that, would obstruct the
<br> ability to observe local reactions at the injection site.
<br>
<br> - Have a condition known to put them at high risk for severe COVID-19, including those
<br> with any of the following risk factors: Hypertension, diabetes mellitus, chronic
<br> pulmonary disease, asthma, chronic liver disease, known stage 3 or worse chronic
<br> kidney disease
<br>
<br> - Anticipating the need for immunosuppressive treatment within the next 6 months.
<br>
<br> Other inclusion or exclusion criteria may apply.
<br> | | COVID-19;Infection Viral;Infections | Biological: VB10.2129;Biological: VB10.2210 | Incidence and frequency of local and systemic solicited adverse events (AEs);Incidence and frequency of local and systemic unsolicited AEs;Incidence and frequency of serious AEs (SAEs) | | | | Yes | False | | |
| → | NCT05079165 | 26 October 2021→8 November 2021 | Covid Vaccination in Liver Transplantation | EVALUATION OF THE RESPONSE TO mRNA SARS-CoV-2 VACCINE IN A COHORT OF LIVER TRANSPLANTED OR LISTED PATIENTS | VACCHEPA | University Hospital, Strasbourg, France | 14/10/2021 | 20211014 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05079165 | Recruiting | No | 18 Years | N/A | All | June 1, 2021 | 300 | Observational | | | France | ; | François FAITOT, MD, PhD;François FAITOT, MD, PhD | | francois.faitot@chru-strasbourg.fr;francois.faitot@chru-strasbourg.fr | 33 3.88 12 72 85;33 3.88 12 72 85 | |
<br> Inclusion criteria:
<br>
<br> - Liver transplanted patients for > 6 months after transplantation
<br>
<br> - Listed cirrhotic patients
<br>
<br> - Age >18 years-old
<br>
<br> - Consent for vaccination with mRNA vaccine
<br>
<br> Exclusion criteria:
<br>
<br> - Vaccination with non mRNA anti-SARS-CoV-2 vaccine
<br>
<br> - Expressed opposition to participation to the study
<br> | | COVID-19 | | Retrospective study of the serological response to the anti-SARS-CoV-2 mRNA vaccine→Retrospective description of the serological response to the anti-SARS-CoV-2 mRNA vaccine | | | | Yes | False | | |
| → | NCT05079178 | 26 October 2021→8 November 2021 | Newborns of COVID-19 Mothers in Level III Services in Alsace→Newborns in Level III Services in Alsace From Mothers With COVID-19 | Retrospective Clinical Study of the Care and Follow-up in the First Month of Life of Newborns of COVID-19 Mothers in Level III Services in Alsace (Strasbourg and Mulhouse)→Retrospective Clinical Study of the Care and Follow-up in the First Month of Life of Newborns in Level III Services in Alsace From Mothers With COVID-19 | COVID-Néo | University Hospital, Strasbourg, France | 14/10/2021 | 20211014 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05079178 | Recruiting | No | N/A | 1 Year | All | June 1, 2020 | 50 | Observational | | | France | ; | Pierre KUHN, MD, PhD;Pierre kUHN, MD, PhD | | Pierre.kuhn@chru-strasbourg.fr;Pierre.kuhn@chru-strasbourg.fr | 33 3 88 12 77 79;33 3 88 12 77 79 | |
<br> Inclusion criteria:
<br>
<br> - Newborns born between March 1 and June 30, 2020 to COVID 19 positive mothers in
<br> Strasbourg University Hospital or Mulhouse Hospital.
<br>
<br> - Parents' non-opposition to the analysis of hospitalization data for children contained
<br> in the medical file
<br>
<br> Exclusion criteria:
<br>
<br> - Parents' opposition to the analysis of hospitalization data for children contained in the
<br> medical file
<br> →
<br> Inclusion criteria:
<br>
<br> - Newborns born between March 1 and June 30, 2020 to COVID 19
<br>
<br> - From positive mothers in Strasbourg University Hospital or Mulhouse Hospital.
<br>
<br> - Parents' non-opposition to the analysis of hospitalization data for children contained
<br> in the medical file
<br>
<br> Exclusion criteria:
<br>
<br> - Parents' opposition to the analysis of hospitalization data for children contained in the
<br> medical file
<br> | | COVID-19 | | Retrospective study concerning the care and follow-up in the first month of life of newborns of COVID-19 mothers in level III services in Alsace→Retrospective description of the care and follow-up in the first month of life of newborns in level III services in Alsace from mothers with COVID-19 | | | | No | False | | |
| → | NCT05079191 | 26 October 2021→8 November 2021 | Impact of the CT Scan in Patients With Suspected Covid-19 | Diagnostic Performance and Predictive Impact of the CT Scan in Patients With Suspected Covid-19 | SCAN-COV-HUS | University Hospital, Strasbourg, France | 14/10/2021 | 20211014 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05079191 | Recruiting | No | 18 Years | N/A | All | June 1, 2020 | 2000 | Observational | | | France | ; | Mickaël OHANA, MD, PhD;Mickaël OHANA, MD, PhD | | mickael.ohana@chru-strasbourg.fr;mickael.ohana@chru-strasbourg.fr | 33 3 69 55 11 17;33 3 69 55 11 17 | |
<br> Inclusion criteria
<br>
<br> - Adult patient (=18 years old)
<br>
<br> - Patient admitted to Strasbourg University Hospitals for suspicion of Covid-19, between
<br> 03/01/2020 and 04/29/2020
<br>
<br> - Availability of at least one chest CT scan during hospitalization
<br>
<br> - Subject not having expressed his opposition, after information, to the reuse of his
<br> data for the purposes of this research.
<br>
<br> Non-inclusion criteria
<br>
<br> - Patient who expressed his opposition to participating in the study
<br>
<br> - Patient under legal protection
<br>
<br> - Patient under guardianship or guardianship
<br> | | COVID-19 | | Retrospective study of the diagnostic performance of the chest scanner in suspected Covid-19→Retrospective study of the chest scanner in suspected Covid-19 | | | | No | False | | |
| → | NCT05080244 | 1 November 2021→8 November 2021 | WHO COVID-19 - Evaluation of the Efficacy of Probiotics to Reduce the Occurrence of Long COVID | Evaluation of the Efficacy of Probiotics Taken During the Acute Phase of COVID-19 to Reduce the Occurrence of Long COVID | PROVID-LD | Centre de recherche du Centre hospitalier universitaire de Sherbrooke | 28/09/2021 | 20210928 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05080244 | Recruiting | No | 18 Years | N/A | All | October 28, 2021 | 618 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | N/A | Canada | ; ; | Jean-Charles Pasquier, MD, PhD;Audrey Hamel-Thibault, MSc;Audrey Hamel-Thibautl, MSc | | ;Audrey.Hamel-Thibault@USherbrooke.ca;Audrey.Hamel-Thibault@USherbrooke.ca | ;819-346-1110;819-346-1110 | CIUSSSE-CHUS; |
<br> Inclusion Criteria:
<br>
<br> - 18 years and over
<br>
<br> - = 10 days between the COVID-19 diagnosis and the inclusion
<br>
<br> - Having symptoms of the COVID-19 at inclusion
<br>
<br> - Living in Quebec for the next 90 days
<br>
<br> - Self-caring at home
<br>
<br> - Able to take medication alone
<br>
<br> - With access to a phone or to the Internet
<br>
<br> - Able to give informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Taking probiotic supplements at inclusion
<br>
<br> - Taking antibiotics for a reason other than COVID-19 at inclusion
<br>
<br> - Allergies to soy, lactose, yeast, maltodextrin, vitamin C, potato starch, magnesium
<br> stearate, hypromellose or titanium dioxide
<br>
<br> - Has a chronically weakened immune system (AIDS, lymphoma, chemo-radio-corticosteroid
<br> therapy, immunosuppressive pathology)
<br>
<br> - Was treated with chemo-radio-corticosteroid therapy in the last 6 months
<br>
<br> - Has active cancer
<br>
<br> - Taking immunosuppressive drugs (e.g. anti-rejection treatment after organ transplant)
<br>
<br> - Already participating in another randomized clinical trial
<br>
<br> - Is pregnant, expects to become pregnant in the next few months or is breastfeeding
<br>
<br> - Has any other condition that would prevent safe participation in the study
<br> | | COVID-19 | Dietary Supplement: Probiotics;Dietary Supplement: Placebo | Number of patients with long COVID 90 days after the COVID-19 diagnosis | | | | Yes | False | | |
| → | NCT05083000 | 1 November 2021→8 November 2021 | Reducing Hypoxia in Patients With COVID-19 Using Topotecan With Standard of Care→Reducing Hypoxia in Patients With Coronavirus Disease (COVID-19) Using Topotecan With Standard of Care | Phase I Dose-escalation Study of Topotecan in Moderate-severe COVID-19 Patients | | National University Hospital, Singapore | 11/10/2021 | 20211011 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05083000 | Recruiting | No | 21 Years | 99 Years | All | August 16, 2021 | 24 | Interventional | Allocation: N/A. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | India | ; ; | Anand JEYASEKHARAN;Anand JEYASEKHARAN;Ajoy Oommen John | | ;anand_jeyasekharan@nuhs.edu.sg;ajoyoommenjohn@gmail.com | ;+65 6779 5555;+91 7639195315 | National University Hospital, Singapore; |
<br> Inclusion Criteria:
<br>
<br> - SARS-CoV-2 infection confirmed by at least 1 positive PCR test
<br>
<br> - Moderate COVID as evidenced by Oxygen saturation <93% on room air (or <88% if prior
<br> CLD)
<br>
<br> - Admission to emergency department for monitoring and/or supportive care:
<br>
<br> - The following biochemical markers:
<br>
<br> - Absolute neutrophil count (ANC) = 1.5 x 109/L. Platelets = 100 x 109/L, Haemoglobin =
<br> 9x 109/L.
<br>
<br> - Bilirubin < 1.5 times upper limit of normal (ULN). ALT and AST < 2.5 times ULN.
<br>
<br> - Calculated creatinine clearance of = 30ml/min calculated using the formula of
<br> Cockcroft and Gault: (140-age) x mass (kg)/)72x creatinine mg/dl); multiple by 0.85 if
<br> female.
<br>
<br> - Laboratory features of cytokine release, as defined by any 1 of the following:
<br>
<br> i. CRP > 75mg/L ii. LDH > ULN iii. D-dimer > 1.0 mg/L iv. Ferritin > 500ng/ml v.
<br> Elevated IL-6 levels
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients requiring mechanical ventilation
<br>
<br> - Any immunosuppressive medication including chemotherapy(excluding steroids)
<br> administered concurrently or within last 14 days.
<br>
<br> - Patients with uncontrolled diabetes mellitus (HbA1C within 1 month >8)
<br>
<br> - Pregnancy or Breastfeeding.
<br>
<br> - Known allergy to Topotecan. Unconjugated hyperbilirubinemia on a fasting LFT, which
<br> can indicate Gilberts Syndrome.
<br>
<br> - Suspected active bacterial, fungal, or other infection in addition to COVID-19.
<br>
<br> - Any condition that would, in the opinion of the Investigator, increase the risk of the
<br> participant
<br>
<br> - by participating in the study.
<br>
<br> - Inability to provide consent.
<br>
<br> - Unable to comply with study procedures.
<br> →
<br> Inclusion Criteria:
<br>
<br> - Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection confirmed by at
<br> least 1 positive Polymerase Chain Reaction (PCR) test
<br>
<br> - Moderate COVID as evidenced by Oxygen saturation <93% on room air (or <88% if prior
<br> CLD)
<br>
<br> - Admission to emergency department for monitoring and/or supportive care:
<br>
<br> - The following biochemical markers:
<br>
<br> - Absolute neutrophil count (ANC) = 1.5 x 109/L. Platelets = 100 x 109/L, Haemoglobin =
<br> 9x 109/L.
<br>
<br> - Bilirubin < 1.5 times upper limit of normal (ULN). Alanine aminotransferase (ALT) and
<br> Aspartate Aminotransferase (AST) < 2.5 times ULN.
<br>
<br> - Calculated creatinine clearance of = 30ml/min calculated using the formula of
<br> Cockcroft and Gault: (140-age) x mass (kg)/)72x creatinine mg/dl); multiple by 0.85 if
<br> female.
<br>
<br> - Laboratory features of cytokine release, as defined by any 1 of the following:
<br>
<br> i. C-reactive protein (CRP)> 75mg/L ii. Lactate Dehydrogenase (LDH) > ULN iii. D-dimer
<br> > 1.0 mg/L iv. Ferritin > 500ng/ml v. Elevated Interleukin-6 levels
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients requiring mechanical ventilation
<br>
<br> - Any immunosuppressive medication including chemotherapy(excluding steroids)
<br> administered concurrently or within last 14 days.
<br>
<br> - Patients with uncontrolled diabetes mellitus (HbA1C within 1 month >8)
<br>
<br> - Pregnancy or Breastfeeding.
<br>
<br> - Known allergy to Topotecan. Unconjugated hyperbilirubinemia on a fasting Liver
<br> Function Test (LFT), which can indicate Gilberts Syndrome.
<br>
<br> - Suspected active bacterial, fungal, or other infection in addition to COVID-19.
<br>
<br> - Any condition that would, in the opinion of the Investigator, increase the risk of the
<br> participant
<br>
<br> - by participating in the study.
<br>
<br> - Inability to provide consent.
<br>
<br> - Unable to comply with study procedures.
<br> | | COVID-19 Respiratory Infection | Drug: Topotecan | Maximal tolerable dose of Topotecan | | | | Yes | False | | |
| → | NCT05087199 | 1 November 2021→8 November 2021 | COVID-19 Infection in Patients With Chronic Pulmonary Diseases. | COVID-19 Infection in Patients With Chronic Pulmonary Diseases. | | Sohag University | 20/10/2021 | 20211020 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05087199 | Not recruiting | No | 16 Years | 100 Years | All | November 1, 2021 | 100 | Observational | | | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Subjects with confirmed diagnosis of COVID-19 infection by:
<br>
<br> RT-PCR And Chest Computed tomography and laboratoty investigations. Patients with chronic
<br> chest disease including (COPD, bronchial asthma, ILD, bronchiectasis).
<br>
<br> Exclusion Criteria:
<br>
<br> - Those who are diagnosed with viral pneumonia caused by viruses other than COVID-19.
<br>
<br> Those who are not confirmed to be COVID-19 with PCR or by radiological and laboratory
<br> investigations.
<br> | | COVID-19 Infection in Patients With Chronic Pulmonary Diseases→COVID-19;Chronic Pulmonary Disease | Diagnostic Test: Rt-PCR. | Inter-relationship between the severity of COVID-19 infection and chronic pulmonary diseases.→Effect of COVID-19 on patients with chronic pulmonary diseases | | | | Yes | False | | |
| → | NCT05087290 | 1 November 2021→8 November 2021 | LOnger-term Effects of COVID-19 INfection on Blood Vessels And Blood pRessure (LOCHINVAR) | Longer-term Effects of COVID-19 on Blood Vessels and Blood Pressure (LOCHINVAR) Phenotyping Study | LOCHINVAR | University of Glasgow | 18/10/2021 | 20211018 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05087290 | Recruiting | No | 30 Years | 60 Years | All | September 30, 2021 | 150 | Observational | | | United Kingdom | ; | Stefanie Lip, BSc.,MBChB MRCP(UK);Stefanie Lip, MBChB | | Stefanie.Lip@glasgow.ac.uk;Stefanie.Lip@glasgow.ac.uk | 01414522599;0141 452 2599 | |
<br> Inclusion Criteria:
<br>
<br> - Age 30-60 years
<br>
<br> - Admission between 01/09/2020 - 31/12/2021
<br>
<br> - Clinically suspected or Confirmed COVID-19 Reverse Transcription-Polymerase Chain
<br> Reaction (RT-PCR) test confirmed COVID-19 on admission
<br>
<br> - No history of hypertension or current drug treatment for hypertension
<br>
<br> Controls
<br>
<br> 1. Age 30-60
<br>
<br> 2. No history of hypertension
<br>
<br> 3. No antihypertensive drugs
<br>
<br> 4. Confirmed RT-PCR test negative and admission through Queen Elizabeth University
<br> Hospital immediate assessment unit and acute receiving units 01/04/2020 to 31/12/2021
<br> or no history of SARS-CoV-2 infection or COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> Inability to give informed consent/lack of capacity Non-English, Arabic, Polish or Urdu
<br> speakers BMI >40 eGFR <60 ml/min Pregnancy History of
<br>
<br> - Cancer within 5 years
<br>
<br> - Persistent atrial fibrillation
<br>
<br> - Severe illness, at investigator discretion Prescription of
<br>
<br> - BP lowering drugs
<br>
<br> - Oral Corticosteroid (chronic use)
<br>
<br> - Immunosuppressive agents
<br>
<br> - Oral NSAIDs (chronic use)
<br> | | Hypertension;Covid19 | Other: Cases;Other: Controls | 24-hour ABPM Systolic Blood Pressure | | | | Yes | False | | |
| → | NCT05091307 | 1 November 2021→8 November 2021 | A Study of Ad26.COV2.S and Influenza Vaccines in Healthy Adults | A Randomized, Double-blind, Phase 3 Study to Evaluate Safety, Reactogenicity, and Immunogenicity of Co-administration of Ad26.COV2.S and Influenza Vaccines in Healthy Adults 18 Years of Age and Older | | Janssen Vaccines & Prevention B.V. | 01/10/2021 | 20211001 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05091307 | Not recruiting | No | 18 Years | N/A | All | November 2, 2021 | 1680 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 3 | United States;Belgium;Poland;Spain;Belgium;Poland;Spain;United States | ; | Janssen Vaccines & Prevention B.V. Clinical Trial;Study Contact | | ;JNJ.CT@sylogent.com | ;844-434-4210 | Janssen Vaccines & Prevention B.V.; |
<br> Inclusion Criteria:
<br>
<br> - Participant must be healthy, in the investigator's clinical judgment, as confirmed by
<br> medical history, physical examination, and vital signs performed at screening.
<br> Participants may have underlying illnesses, as long as the symptoms and signs are
<br> medically controlled
<br>
<br> - Participant either received complete primary vaccination with an authorized/licensed
<br> coronavirus disease-2019 (COVID-19) vaccine (completed greater than or equal to [>=] 6
<br> months prior to first study vaccination) or is COVID-19 vaccine-naive
<br>
<br> - All participants who were born female and are of childbearing potential must: a. Have
<br> a negative highly sensitive urine pregnancy test at screening, b. Have a negative
<br> highly sensitive urine pregnancy test on the day of each study vaccine administration
<br>
<br> - Participant agrees to not donate or receive bone marrow, blood, and blood products
<br> from the administration of the study vaccine until 3 months after receiving the study
<br> vaccines
<br>
<br> - Participant must be willing to provide verifiable identification to be contacted and
<br> to contact the investigator during the study
<br>
<br> Exclusion Criteria:
<br>
<br> - Participant has a history of malignancy within 5 years before screening (exceptions
<br> are squamous and basal cell carcinomas of the skin and carcinoma in situ of the
<br> cervix, or malignancies considered cured with minimal risk of recurrence per
<br> investigator's clinical judgment)
<br>
<br> - Participant has a clinically significant acute illness (this does not include minor
<br> illnesses such as diarrhea or mild upper respiratory tract infection) or temperature
<br> >= 38.0 degrees celsius (ºC) (100.4 degrees fahrenheit [°F]) within 24 hours prior to
<br> the planned dose of study vaccine; randomization at a later date is permitted at the
<br> discretion of the investigator
<br>
<br> - Participant has history of thrombosis with thrombocytopenia syndrome (TTS) or
<br> heparin-induced thrombocytopenia and thrombosis (HITT)
<br>
<br> - Participant has history of capillary leak syndrome
<br>
<br> - Participant received or plans to receive a severe acute respiratory syndrome
<br> coronavirus(-2) (SARS-CoV-2) vaccine less than 6 months prior to first study
<br> vaccination or during the course of this study (other than study vaccination)
<br>
<br> - Participant has a history of any neurological disorders or seizures including
<br> Guillain-Barre syndrome, with the exception of febrile seizures during childhood
<br> | | COVID-19 Prevention | Biological: Ad26.COV2.S;Other: Placebo;Biological: Influenza Vaccine | Groups 3 and 4: S-ELISA GMCs 28 Days After the Administration of Ad26.COV2.S Vaccine;Groups 1 and 2: Spiked-Enzyme-linked Immunosorbent Assay (S-ELISA) Geometric Mean Concentrations (GMCs) 28 Days After the Administration of Ad26.COV2.S Vaccine;Groups 3 and 4: GMT of HI Antibody Against each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent High-dose Influenza Vaccine;Groups 1 and 2: Geometric Mean Titers (GMTs) of Hemagglutination Inhibition (HI) Antibody Against each of the 4 Influenza Vaccine Strains at 28 Days After the Administration of a Seasonal Quadrivalent Standard-dose Influenza Vaccine | | | | Yes | False | | |
| → | NCT05092529 | 1 November 2021→8 November 2021 | Psychological Impact of COVID-19 on Intensive Care Survivors | The Psychological Impact of Surviving an Intensive Care Admission Due to Coronavirus Disease 2019 (COVID-19) on Patients in the United Kingdom | PIM-COVID | Royal Liverpool University Hospital | 18/10/2021 | 20211018 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05092529 | Recruiting | No | 18 Years | N/A | All | November 17, 2020 | 1500 | Observational | | | United Kingdom | ; ; ; | Alicia AC Waite;Ingeborg D Welters;Alicia AC Waite;Ingeborg D Welters | | ;;PIM-COVID@liverpoolft.nhs.uk;i.welters@liverpool.ac.uk | ;;+44 151 706 2410; | Royal Liverpool University Hospital;University of Liverpool; |
<br> Inclusion Criteria:
<br>
<br> - Adult patients =18 years
<br>
<br> - Survival to intensive care / high dependency unit discharge following an admission of
<br> =24 hours
<br>
<br> - Treated for COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> - Unable to complete questionnaires
<br>
<br> - Unable or unwilling to consent
<br>
<br> - Unable to speak, understand or communicate in English
<br>
<br> - Patients with diagnosed, pre-existing cognitive impairment (at the time of ICU
<br> admission)
<br>
<br> - Patients without a fixed abode, at which postal questionnaires might be received, and
<br> who have no access to a personal email address.
<br> | | COVID-19;Psychological Distress;Depression;Anxiety;Post-traumatic Stress Disorder;Post Intensive Care Syndrome | | Anxiety;Depression;Symptoms of trauma→Symptoms of trauma;Depression;Anxiety | | | | No | False | | |
| → | NCT05092555 | 1 November 2021→8 November 2021 | Clinical Presentations and Outcomes of Patients With Covid-19 Pneumonia | Clinical Presentations and Outcomes of Patients With Covid-19 Pneumonia | | Sohag University | 22/10/2021 | 20211022 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05092555 | Not recruiting | No | 18 Years | N/A | All | October 15, 2021→November 1, 2021 | 200 | Observational | | | | ; ; | Hamdy A Mohammadeen, Ass.prof;Mona T Hussen, Ass.prof;Ghada M Bahy | | ;;ghadabahy567@gmail.com | ;;+201063551135 | Sohag University;Sohag University; |
<br> Inclusion Criteria:
<br>
<br> 1. Age =18 years old
<br>
<br> 2. Patients with covid-19 pneumonia confirmed by:
<br>
<br> RT-PCR Or pattern of covid-19 in computed tomography (CT) scan ( ground-glass opacity
<br> indicative of pneumonia on CT, opinion on consolidation, etc) with laboratory
<br> investigations
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients not confirmed to be covid-19 with PCR or radiologically.
<br>
<br> 2. Patients who are diagnosed as bacterial pneumonia.
<br> →
<br> Inclusion Criteria:
<br>
<br> 1. Age =18 years old
<br>
<br> 2. Patients with covid-19 pneumonia confirmed by:
<br>
<br> Reverse transcription polymerase chain reaction Or pattern of covid-19 in computed
<br> tomography (CT) scan ( ground-glass opacity indicative of pneumonia on CT, opinion on
<br> consolidation, etc) with laboratory investigations
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients not confirmed to be covid-19 with PCR or radiologically.
<br>
<br> 2. Patients who are diagnosed as bacterial pneumonia.
<br> | | COVID-19 Pneumonia | Diagnostic Test: Nasopharyngeal swap for RT-PCR→Diagnostic Test: Nasopharyngeal swap for Reverse transcription polymerase chain reaction | Post covid fibrosis | | | | Yes | False | | |
| → | NCT05092737 | 1 November 2021→8 November 2021 | Physiological Response to Prone Position in ARDS COVID-19→Physiological Response to Prone Position in COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS) | Physiological Response to Prone Positioning in Intubated Adults With COVID-19 Acute Respiratory Distress Syndrome: a Retrospective Study→Physiological Response to Prone Position in Intubated Adults With COVID-19 Associated Acute Respiratory Distress Syndrome (ARDS): a Retrospective Study | | University of Lausanne Hospitals | 21/10/2021 | 20211021 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05092737 | Recruiting | No | 18 Years | N/A | All | August 1, 2021 | 45 | Observational | | | Switzerland | ; | Lise Piquilloud Imboden, PD&MER;Lise Piquilloud Imboden, PD&MER | | lise.piquilloud@chuv.ch;lise.piquilloud@chuv.ch | +41 79 556 68 27;+41 79 556 68 27 | |
<br> Inclusion Criteria:
<br>
<br> - COVID-19 moderate to severe ARDS
<br>
<br> - Invasive mechanical ventilation
<br>
<br> - Prone positioning
<br>
<br> - admitted in ICU
<br>
<br> Exclusion Criteria:
<br>
<br> - already proned in referring hospital
<br>
<br> - pronation during ECMO only
<br>
<br> - denied consent for data analysis
<br> →
<br> Inclusion Criteria:
<br>
<br> - COVID-19 associated moderate to severe ARDS
<br>
<br> - Invasive mechanical ventilation
<br>
<br> - Prone positioning
<br>
<br> - admitted to ICU
<br>
<br> Exclusion Criteria:
<br>
<br> - already sustained prone positioning in referring hospital
<br>
<br> - pronation during ECMO only
<br>
<br> - denied consent for data analysis
<br> | | ARDS;Sars-CoV-2 Infection | Procedure: Prone positioning | PaO2/FiO2 | | | | Yes | False | | |
| → | NCT05094609 | 1 November 2021→8 November 2021 | Phase 1 Trial of ChAd68 and Ad5 Adenovirus COVID-19 Vaccines Delivered by Aerosol | Phase 1, Open Label Study to Evaluate the Safety and Immunogenicity of ChAd68 and AdHu5 Vector-based Trivalent COVID-19 Vaccines Delivered Via Inhaled Aerosol | | McMaster University | 25/10/2021 | 20211025 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05094609 | Not recruiting | No | 18 Years | 65 Years | All | November 29, 2021 | 30 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1 | Canada | ; | Fiona M Smaill, MD;Fiona M Smaill, MD | | ;smaill@mcmaster.ca | ;905-521-2100 | McMaster University; |
<br> Inclusion Criteria:
<br>
<br> 1. Healthy human subjects who are between 18 and 65 years of age.
<br>
<br> 2. Have completed a COVID vaccine series with two doses of a licensed mRNA vaccine at
<br> least 3 months prior.
<br>
<br> 3. HIV antibody negative.
<br>
<br> 4. Able to understand and comply with protocol requirements and instructions; able to
<br> attend scheduled study visits and complete required investigations.
<br>
<br> 5. For women, negative pregnancy test and for those women of child-bearing potential
<br> practising two acceptable forms of contraception for the duration of the study.
<br>
<br> 6. For men, using barrier contraception for the duration of the study.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. History of probable or confirmed diagnosis of COVID-19 infection, based on Ontario
<br> Health case definitions.
<br>
<br> 2. Subjects who have received any recombinant adenoviral-vectored COVID-19 vaccine, e.g.
<br> AstraZeneca COVISHIELD COVID-19 vaccine.
<br>
<br> 3. Subjects who have received more than 2 doses of any COVID-19 vaccine.
<br>
<br> 4. Pregnant or lactating women.
<br>
<br> 5. Subjects who have any acute or chronic illnesses any relevant findings on physical
<br> examination or are receiving any immunosuppressive therapy in the opinion of the
<br> investigator likely to affect the immune system including current use of inhaled or
<br> nasal steroids.
<br>
<br> 6. Subjects with a history of any bleeding disorder or receiving any drug treatment that
<br> in the opinion of the investigator may increase the risk of bleeding.
<br>
<br> 7. Subjects with a history of respiratory diseases requiring regular treatment, e.g.
<br> asthma, COPD, interstitial lung diseases, bronchiectasis.
<br>
<br> 8. Current cigarette smokers, current e-cigarette smokers and ex-smokers who have quit
<br> less than a year ago, as reported by the subject.
<br>
<br> 9. Subjects with clinically significant abnormal baseline spirometry tests: FEV1<80%
<br> predicted, FVC<80% predicted, FEV1/FVC<70%; DLCO<70% predicted.
<br>
<br> 10. Any health-related condition for which study bronchoscopy is contraindicated.
<br>
<br> 11. Subjects whose baseline laboratory values are outside of the normal range, unless the
<br> abnormality is considered not clinically relevant by the investigator. A single repeat
<br> test is allowed during the screening period.
<br>
<br> 12. Subjects whose use of alcohol or drugs would, in the opinion of the investigator,
<br> interfere with adherence to the study protocol.
<br>
<br> 13. Subjects who are using, or have a history of using, inhaled cocaine, metamphetamine or
<br> other inhaled or smoked recreational drugs. Subjects who give a history of smoking
<br> marijuana more than a year ago may be enrolled as long as they agree not to smoke
<br> marijuana for the duration of the study.
<br>
<br> 14. Failure to provide written consent.
<br>
<br> 15. Known allergy to vaccine components.
<br>
<br> 16. Any abnormality on chest x-ray suggestive of clinically significant respiratory
<br> disease.
<br>
<br> 17. Previous receipt of any experimental adenovirus-vector vaccine by the aerosol route.
<br>
<br> 18. History of severe reaction to a previous COVID vaccination (including hives,
<br> difficulty breathing, angioedema, high fever, seizure).
<br>
<br> 19. History of venous or arterial thrombosis with thrombocytopenia following any
<br> vaccination.
<br>
<br> 20. History of cerebral venous thrombosis with thrombocytopenia.
<br>
<br> 21. History of heparin induced thrombocytopenia.
<br>
<br> 22. History of myocarditis or pericarditis.
<br>
<br> 23. History of Bell's Palsy.
<br> | | COVID-19;SARS-CoV2 Infection | Biological: Ad5-triCoV/Mac;Biological: ChAd-triCoV/Mac | Number of participants reporting adverse events and severity of adverse events following Ad5-triCoV/Mac vaccination;Number of participants reporting adverse events and severity of adverse events following ChAd-triCoV/Mac vaccination→Number of participants reporting adverse events and severity of adverse events following ChAd-triCoV/Mac vaccination;Number of participants reporting adverse events and severity of adverse events following Ad5-triCoV/Mac vaccination | | | | Yes | False | | |
| → | NCT05094635 | 1 November 2021→8 November 2021 | Immunogenicity Against SARS-CoV-2 in COVID-19 Close Contacts | Characteristics of Immunogenicity Against SARS-CoV-2 in the Community With Home-quarantined Covid-19 Patients in Ho Chi Minh City, Vietnam | | University of Medicine and Pharmacy at Ho Chi Minh City | 25/10/2021 | 20211025 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05094635 | Not recruiting | No | 18 Years | N/A | All | November 30, 2021 | 772 | Observational | | | Vietnam | ; | Tuan D Tran, PhD;Lan TN Vuong, PhD | | ;lanvuong@ump.edu.vn | ;+84901183918 | Study Principal Investigator; |
<br> Inclusion Criteria:
<br>
<br> - People who lived in the two blocks (V and Y) of Ngo Gia Tu apartment, located in
<br> District 10, Ho Chi Minh City, Vietnam, from July to September 2021
<br>
<br> - 18 years of age and older
<br>
<br> - Ability to understand and willingness to sign a written informed consent document.
<br>
<br> Exclusion Criteria:
<br>
<br> - People who were diagnosed with primary or secondary immunodeficiencies induced by
<br> diseases or medical treatments (immunosuppressants, chemotherapy, radiation therapy,
<br> ect.)
<br> | | Covid19;Vaccine Reaction | Diagnostic Test: SARS-CoV-2 IgG II Quant | SARS-CoV-2 anti-RBD IgG concentration | | | | Yes | False | | |
| → | NCT05094648 | 1 November 2021→8 November 2021 | High Flow Nasal Therapy in Covid 19 Patient | Predictors of Success of High Flow Nasal Therapy in Covid 19 Patients | | Maha Mahmoud Ahmed | 25/10/2021 | 20211025 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05094648 | Not recruiting | No | 18 Years | 80 Years | All | November 1, 2021 | 60 | Observational | | | | | Maha Mahmoud | | maha.mahmoud.1994@gmail.com | 01063453193 | |
<br> Inclusion Criteria:
<br>
<br> - All Patients above 18 y old that will be diagnosed as COVID 19 based on PCR testing,
<br> who fulfil criteria that indicate need for high flow nasal therapy.
<br>
<br> Exclusion Criteria:
<br>
<br> - o Children less than 18 y old
<br>
<br> - Oropharyngeal and Nasopharyngeal swap negative patients
<br>
<br> - Patients who will refuse inclusion in the study
<br> | | High Flow Nasal Therapy | Other: high flow nasal therapy | predictors of success of high flow nasal therapy in covid 19 patients | | | | Yes | False | | |
| → | NCT05094687 | 1 November 2021→8 November 2021 | Cutaneous Manifestations of Coronavirus Disease 2019(COVID-19). | Cutaneous Manifestations of Coronavirus Disease 2019(COVID-19). | | Jinnah Postgraduate Medical Centre | 23/10/2021 | 20211023 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05094687 | Not recruiting | No | 5 Years | 90 Years | All | January 1, 2021 | 350 | Observational [Patient Registry] | | | Pakistan | ; | Rabia Ghafoor, MBBS, FCPS, SCE-Derm(MRCP-UK);Syeda Mahanum Ali, MBBS, Postgraduate Trainee | | ; | ; | Jinnah Postgraduate Medical Centre;Jinnah Postgraduate Medical Centre |
<br> Inclusion Criteria:
<br>
<br> both genders Any age PCR diagnosed COVID-19 patient Covid-19 systemic manifestations as
<br> asymtomatic or symptomatic with or without cutaneous manifestation with or without
<br> comorbidities any duration of systemic and cutaneous disease
<br>
<br> Exclusion Criteria:
<br>
<br> patient with diagnosed case of autoimmune disease on drugs known case of malignancy
<br> recurrent transfusion history diagnosed case of malabsorption syndrome patient who was
<br> already taking immunosuppressant.
<br>
<br> Already having any prior skin disease
<br> →
<br> Inclusion Criteria:
<br>
<br> both genders Any age PCR diagnosed COVID-19 patient COVID-19 systemic manifestations as
<br> asymptomatic or symptomatic with or without cutaneous manifestation with or without
<br> comorbidities any duration of systemic and cutaneous disease
<br>
<br> Exclusion Criteria:
<br>
<br> patient with diagnosed case of autoimmune disease on drugs known case of malignancy
<br> recurrent transfusion history diagnosed case of malabsorption syndrome patient who was
<br> already taking immunosuppressant.
<br>
<br> Already having any prior skin disease
<br> | | Cutaneous Manifestations;Skin Manifestations;COVID-19;COVID-19 Pneumonia;COVID-19 Pandemic;Corona Virus Infection;Coronavirus Disease 2019;Sars-CoV-2 Infection | | Frequency of skin manifestations;COVID-19 Disease Outcome in 350 Subjects.;Cutaneous patterns;Association of Covid-19 disease outcome in correlation with skin manifestation;Patient taking covid-19 treatment before onset of skin manifestation;Skin symptoms→Frequency of skin manifestations;COVID-19 Disease Outcome in 350 Subjects.;Cutaneous patterns;Association of COVID-19 disease outcome in correlation with skin manifestation;Patient taking COVID-19 treatment before onset of skin manifestation;Skin symptoms | | | | Yes | False | | |
| → | NCT05095844 | 1 November 2021→8 November 2021 | National Vaccine Adverse Event Reporting Survey and Etiology | National Vaccine Adverse Event Reporting Survey to Determine the Etiology of Vaccine-Induced Injury | NVAERS | Neuroganics LLC | 13/10/2021 | 20211013 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05095844 | Not recruiting | No | 5 Years | 99 Years | All | November 1, 2021 | 100000 | Observational | | | United States | ; ; | Donald C Cooper, Ph.D.;Donald C Cooper, Ph.D.;Donald C Cooper, Ph.D. | | ;vaccinestudy@protonmail.com;vaccinestudy@protonmail.com | ;303.733.6353; | Chief Science Officer/ Principal Investigator; |
<br> Inclusion Criteria:
<br>
<br> Individuals who have received at least one vaccine dose of ANY of the following vaccines
<br> (below) and experienced adverse reaction within 60 days of vaccine administration:
<br>
<br> 1. Pfizer-BioNTech COVID-19 Vaccine
<br>
<br> 2. Moderna COVID-19 Vaccine
<br>
<br> 3. J&J/Janssen COVID-19 Vaccine
<br>
<br> 4. Diphtheria (e.g., DTP, DTaP, Tdap, DT, Td, TT)
<br>
<br> 5. Haemophilus influenza type b polysaccharide conjugate vaccines (e.g., Hib)
<br>
<br> 6. Hepatitis A (e.g., HAV)
<br>
<br> 7. Hepatitis B (e.g., HBV)
<br>
<br> 8. Human papillomavirus (e.g., HPV)
<br>
<br> 9. Seasonal influenza (e.g., Flu)
<br>
<br> 10. Measles (e.g., MMR)
<br>
<br> 11. Mumps (e.g., MMR, MR, M)
<br>
<br> 12. Meningococcal (e.g., MCV4, MPSV4, MenB-FHbp, MenB-4C)
<br>
<br> 13. Pertussis (e.g., DTP, DTaP, Tdap)
<br>
<br> 14. Pneumococcal conjugate (e.g., PCV)
<br>
<br> 15. Polio (e.g., OPV or IPV)
<br>
<br> 16. Rotavirus (e.g., RV)
<br>
<br> 17. Rubella (e.g., MMR, MR, R)
<br>
<br> 18. Tetanus (e.g., Td)
<br>
<br> 19. Varicella (e.g., VAR).
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Non citizens or permanent residents of the US
<br>
<br> 2. Individuals who have not received at least one vaccine dose in the past 3 years.
<br>
<br> 3. Individuals whose vaccine was administered more than 60 days before symptoms of the
<br> serious adverse event.
<br>
<br> -
<br> | | COVID-19;Vaccine Adverse Reaction;Vaccine Reaction;Vaccine or Biological Substance, Unspecified Causing Adverse Effects in Therapeutic Use;Corona Virus Infection;Blood Clot;Thrombocytopenia;Neuritis;Vasculitis;Influenza | Biological: vaccinated | Adverse Event | | | | Yes | False | | |
| → | NCT05096026 | 1 November 2021→8 November 2021 | Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination Among Elderly Patients | Effect of Electronic and Mail Outreach From Primary Care Physicians for COVID-19 Vaccination Among Elderly Patients | | Kaiser Permanente | 25/10/2021 | 20211025 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05096026 | Not recruiting | No | 65 Years | N/A | All | March 29, 2021 | 8287 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | United States | | Tracy Lieu, MD | | | | The Permanente Medical Group |
<br> Inclusion Criteria:
<br>
<br> -
<br>
<br> Exclusion Criteria:
<br>
<br> Received COVID-19 vaccine prior to Study Outreach 1.
<br> | | Vaccination | Behavioral: Standard PCP Outreach;Behavioral: Culturally Tailored PCP Outreach | Days to COVID-19 vaccination | | | | Yes | False | | |
| → | NCT05096832 | 1 November 2021→8 November 2021 | Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Booster Study | A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Sequential Immunization of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Against COVID-19 in Healthy Adults Aged 18 Years and Older After the Vaccination of 2 Doses of Inactivated Vaccines | COVID-19 | Livzon Pharmaceutical Group Inc. | 21/10/2021 | 20211021 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05096832 | Not recruiting | No | 18 Years | N/A | All | October 31, 2021 | 10722 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | Pakistan | | Yang Jiaming, Dr. | | yangjiaming@livzon.cn | 86-756-7238289 | |
<br> Inclusion Criteria:
<br>
<br> Participants are eligible to be included in the study only if all of the following criteria
<br> apply:
<br>
<br> 1. Voluntarily participate in the study and sign the informed consent form.
<br>
<br> 2. Adults aged 18 years and older at time of consent, male or female.
<br>
<br> 3. Able to and willing to comply with study procedure based on the assessment of the
<br> investigator.
<br>
<br> 4. Participants who have completed the second dose of 2-dose regimen of inactive
<br> vaccination (BBIBP-CorV or CoronaVac) against SARS-CoV-2 in the past 3-6 months (Note:
<br> Participants who received mixed vaccination of BBIBP-CorV and CoronaVac will not be
<br> enrolled).
<br>
<br> 5. Healthy participants or participants with pre-existing stable medical conditions (A
<br> stable medical condition is defined as a disease not requiring significant change in
<br> therapy or hospitalization for worsening disease within 3 months before enrollment).
<br>
<br> 6. Males of reproductive potential and females of childbearing potential voluntarily
<br> agree to take effective and acceptable contraceptive methods from the signing of
<br> informed consent form to 3 months after vaccination; and a female participant of
<br> childbearing potential should have a negative pregnancy test at screening and on the
<br> day of vaccination (day 0).
<br>
<br> Female participants of non-childbearing potential may be enrolled in the study.
<br> Non-childbearing potential is defined as surgically sterile (history of bilateral tubal
<br> ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as amenorrhea
<br> for = 12 consecutive months prior to screening without an alternative medical cause).
<br>
<br> Exclusion Criteria:
<br>
<br> Participants are excluded from the study if any of the following criteria apply:
<br>
<br> 1. History of previous COVID-19 infection.
<br>
<br> 2. Positive for SARS-CoV-2 test by RT-PCR during screening period (Note: Participants can
<br> be enrolled in the study and receive the investigational product without waiting for
<br> the report of the SARS-CoV-2 test by RT-PCR).
<br>
<br> 3. History of severe acute respiratory syndrome (SARS), Middle East respiratory syndrome
<br> (MERS), and other human coronavirus infections or diseases.
<br>
<br> 4. History of severe allergy to any vaccine, e.g., acute allergic reactions, urticaria,
<br> skin eczema, dyspnea, angioneurotic edema or abdominal pain etc., or be allergic to
<br> any components of V-01.
<br>
<br> 5. Any confirmed or suspected immunosuppression or immunodeficiency condition known from
<br> medical history, including human immunodeficiency virus (HIV) infection, asplenia.
<br>
<br> 6. Serious or uncontrolled cardiovascular diseases, nervous system disorders (e.g.,
<br> Guillain-Barre syndrome), blood and lymphatic system disorders, immune system
<br> disorders, hepatorenal disorders, respiratory system disorders (e.g., active
<br> tuberculosis, pulmonary fibrosis), metabolic and skeletal systems disorders or
<br> malignant tumors (except for skin basal cell carcinoma or in situ carcinoma of uterine
<br> cervix that has been cured for more than 5 years).
<br>
<br> 7. Hereditary hemorrhagic tendency or coagulation dysfunction, or a history of thrombosis
<br> or hemorrhagic disease, or requirement of continuous use of anticoagulants.
<br>
<br> 8. Prior use of any medication to prevent COVID-19 within 1 week before signing the
<br> informed consent form (except for previous vaccines, BBIBP-CorV or CoronaVac), e.g.,
<br> use of antipyretics without pyrexia and any other symptoms.
<br>
<br> 9. Received attenuated live vaccine within 28 days before the vaccination or any other
<br> vaccines (licensed or investigational) within 14 days before the vaccination.
<br>
<br> 10. Has participated in an interventional clinical study within 1 months prior to the day
<br> of vaccination.
<br>
<br> 11. Injection of immunoglobulin and/or other blood products within 3 months before the
<br> administration of study vaccine.
<br>
<br> 12. Long-term use (continuous use > 14 days) of glucocorticoids (= 10 mg/day of prednisone
<br> or its equivalent dose) or other immunosuppressive agents within 6 months before
<br> signing the informed consent form; however, enrollment is allowed for the following
<br> conditions: inhaled or topical use of topical steroids, or short-term use (treatment
<br> course = 14 days) of oral steroids.
<br>
<br> 13. Pregnant or breastfeeding women.
<br>
<br> 14. Planning to donate blood during the study period.
<br>
<br> 15. Suspected or known alcohol or drug dependence.
<br>
<br> 16. History of severe psychiatric disorders which may affect study participation.
<br>
<br> 17. Planning to permanently move from the local area before study completion or leave the
<br> local area for a long time during the period of study visits, so that the scheduled
<br> visits cannot be followed.
<br>
<br> 18. Those considered by the investigator as inappropriate to participate in the study.
<br> | | COVID-19 Pandemic | Biological: Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01);Biological: Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) | The incidence of adverse events (AEs);the relative efficacy of recombinant SARS-CoV-2 fusion protein vaccine (V-01) as a booster to prevent symptomatic and RT-PCR positive COVID-19 (mild or above severity) | | | | Yes | False | | |
| → | NCT05096845 | 1 November 2021→8 November 2021 | Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) Phase III | A Global, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III Clinical Study to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Adults Aged 18 Years and Older | COVID-19 | Livzon Pharmaceutical Group Inc. | 21/10/2021 | 20211021 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05096845 | Recruiting | No | 18 Years | N/A | All | August 25, 2021 | 22500 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | Philippines | | Yang Jiaming, Dr. | | yangjiaming@livzon.cn | 86-756-7238289 | |
<br> Inclusion Criteria:
<br>
<br> The participants can be enrolled only all of the following criteria are met:
<br>
<br> 1. Voluntarily participate in this study and sign the informed consent form;
<br>
<br> 2. Adults aged 18 years and older, male or female;
<br>
<br> 3. According to the assessment of the investigator, the participant has a stable medical
<br> condition (which is defined as no significant changes in therapy or hospitalization
<br> caused by disease aggravation within 3 months before enrollment) and is able to and
<br> willing to follow the requirements of the protocol.
<br>
<br> 4. Males of reproductive potential and females of child-bearing potential voluntarily
<br> agree to take effective and acceptable contraceptive methods from the signing of
<br> informed consent form to 12 months after full-course immunization; females of
<br> child-bearing potential have a negative pregnancy test at screening and at the day of
<br> vaccination.
<br>
<br> Exclusion Criteria:
<br>
<br> Participants meeting any of the following exclusion criteria will not be allowed to
<br> participate in this study:
<br>
<br> 1.History of previous COVID-19 infection; 2.Positive result for RT-PCR test in the
<br> screening period or specific antibody IgG or IgM meet the following criteria:
<br>
<br> 1. If IgG is positive, the participant will be excluded regardless of the results of
<br> other indexes.
<br>
<br> 2. If IgG is negative and IgM is positive, it will be determined whether or not to enroll
<br> such participant after the result of RT-PCR test is obtained;
<br>
<br> 3. If both IgG and IgM are negative, the participant can be vaccinated without waiting
<br> for the RT-PCR test results.
<br>
<br> 3.History of severe acute respiratory syndrome (SARS), middle east respiratory syndrome
<br> (MERS), and other human coronavirus infections or diseases; 4.History of severe allergy to
<br> any vaccine, e.g., acute allergic reactions, urticaria, skin eczema, dyspnea, angioneurotic
<br> edema or abdominal pain etc., or be allergic to any components of V-01; 5.Any confirmed or
<br> suspected immunosuppression or immunodeficiency condition known from medical history,
<br> including human immunodeficiency virus (HIV) infection, asplenia; 6.Serious or uncontrolled
<br> cardiovascular diseases, nervous system disorders (e.g., Guillain-Barre syndrome), blood
<br> and lymphatic system disorders, immune system disorders, hepatorenal disorders, respiratory
<br> system disorders (e.g., active tuberculosis, pulmonary fibrosis), metabolic and skeletal
<br> systems disorders or malignant tumors (except for skin basal cell carcinoma or in situ
<br> carcinoma of uterine cervix that has been cured for more than 5 years); 7.Hereditary
<br> hemorrhagic tendency or coagulation dysfunction, or a history of thrombosis or hemorrhagic
<br> disease, or requirement of continuous use of anticoagulants; 8.Prior use of any medications
<br> to prevent COVID-19, e.g., use of antipyretics without pyrexia and any other symptoms; 9.A
<br> history of vaccination against SARS-CoV-2 (marketed or investigational); 10.Received
<br> attenuated live vaccine within 28 days before the first vaccination or any other vaccines
<br> (licensed or investigational) within 14 days before the first vaccination; 11.Injection of
<br> immunoglobulin and/or other blood products within 3 months before the administration of
<br> study vaccine; 12.Long-term use (continuous use >14 days) of glucocorticoids (=10mg/day of
<br> prednisone or its equivalent dose) or other immunosuppressive agents; however, enrollment
<br> is allowed for the following conditions: inhaled or topical use of topical steroids, or
<br> short-term use (treatment course =14 days) of oral steroids; 13.Pregnant or breastfeeding
<br> women; 14.Planning to donate blood during the study period; 15.Suspected or known alcohol
<br> or drug dependence; 16.History of severe psychiatric disorders which may affect study
<br> participation; 17.Planning to permanently move from the local area before study completion
<br> or leave the local area for a long time during the period of study visits, so that the
<br> scheduled visits cannot be followed; 18.Those considered by the investigator as
<br> inappropriate to participate in the study.
<br> | | COVID-19 Pandemic | Biological: Recombinant SARS-CoV-2 fusion protein vaccine (V-01);Other: Blank Preparation of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) | The efficacy of V-01 for the prevention of symptomatic RT-PCR-positive COVID-19 (mild or above in severity);The incidence of adverse events (AEs) of V-01 | | | | Yes | False | | |
| → | NCT05096858 | 1 November 2021→8 November 2021 | Continuous Glucose Monitorization in Hospitalized Patients With COVID-19 | Assessment of the Effect of Continuous Glucose Monitorization on Glycemic Variability and Insulin's Prescription in Hospitalized Patients With COVID-19 | | Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran | 13/09/2021 | 20210913 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05096858 | Recruiting | No | 18 Years | 100 Years | All | June 1, 2020 | 120 | Observational | | | Mexico | ; ; | ALFONSO GULIAS HERRERO;ALFONSO GULIAS HERRERO;Alhely Gaytan Santillan | | ;alfonso.guliash@incmnsz.mx;alhely.gaytans@incmnsz.mx | ;523123173679;523123173679 | INCMNSZ; |
<br> Inclusion Criteria:
<br>
<br> - Confirmed COVID-19 pneumonia
<br>
<br> - Diabetes mellitus
<br>
<br> Exclusion Criteria:
<br>
<br> - Less than 3 days of hospital care
<br> | | Diabetes Mellitus;Covid19 | | Glucose variability;Insulin use | | | | No | False | | |
| → | NCT05096884 | 1 November 2021→8 November 2021 | Post-Acute Sequelae of COVID-19 (PASC) With Dyspnea on Exertion And Associated TaChycardia TrEatment Study→Post-Acute Sequelae of Coronavirus-19 (COVID-19) With Dyspnea on Exertion And Associated TaChycardia TrEatment Study | Post-Acute Sequelae of COVID-19 (PASC) With DysPnEA on ExertIon And Associated TaChycardia TrEatment Study→Post-Acute Sequelae of Coronavirus-19 (COVID-19) With DysPnEA on ExertIon And Associated TaChycardia TrEatment Study | PEACE | Hackensack Meridian Health | 25/10/2021 | 20211025 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05096884 | Not recruiting | No | 18 Years | 40 Years | All | February 1, 2022 | 20 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Early Phase 1 | United States | ; | David Landers, MD;Jana Tancredi, RN | | ;Jana.tancredi@hmhn.org | ;5519962353 | Hackensack Meridian Health; |
<br> Inclusion Criteria:
<br>
<br> 1. Subject should be between the ages of 18 and 40 with DOE (dyspnea on exertion) for 3 -
<br> 12 months
<br>
<br> 2. Subjects recovered from acute, PCR (polymerase chain reaction) positive, COVID-19
<br> infection
<br>
<br> 3. Recovery from COVID-19 will be defined as substantial improvement in or essential
<br> resolution of initial clinical symptoms
<br>
<br> 4. Demonstration of tachycardia and/or dyspnea with minimal activity (subjectively
<br> different than pre-COVID 19 infection state)
<br>
<br> 5. Abnormal HUTT (heads up tilt test)
<br>
<br> 6. Normal chest x-ray
<br>
<br> 7. Left ventricular ejection fraction (LVEF) >50% by transthoracic echocardiography
<br>
<br> 8. Zva >3.5 as calculated from TTE (transthoracic echocardiogram).
<br>
<br> 9. Hemoglobin/Hematocrit within normal laboratory standards
<br>
<br> 10. Thyroid-stimulating hormone (TSH) within normal laboratory standards
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Active pregnancy (negative pregnancy test is the standard of care prior to HUTT)
<br>
<br> 2. Demonstrate a primary cause of appropriate DOE and sinus tachycardia
<br>
<br> 1. Fevers/infection
<br>
<br> 2. Hypovolemia
<br>
<br> 3. Anemia
<br>
<br> 4. Hyperthyroidism
<br>
<br> 5. Alcohol/drug/medication withdrawal
<br>
<br> 3. Currently taking beta blocker medications
<br>
<br> 4. Currently being treated for pre-existing neurally mediated hypotension/syncope or
<br> known dysautonomia.
<br>
<br> 5. Medical history of chronic lung disease or reactive airway syndrome.
<br> →
<br> Inclusion Criteria:
<br>
<br> 1. Subject should be between the ages of 18 and 40 with DOE (dyspnea on exertion) for 3 -
<br> 12 months
<br>
<br> 2. Subjects recovered from acute, polymerase chain reaction (PCR) positive, COVID-19
<br> infection
<br>
<br> 3. Recovery from COVID-19 will be defined as substantial improvement in or essential
<br> resolution of initial clinical symptoms
<br>
<br> 4. Demonstration of tachycardia and/or dyspnea with minimal activity (subjectively
<br> different than pre-COVID 19 infection state)
<br>
<br> 5. Abnormal HUTT (heads up tilt test)
<br>
<br> 6. Normal chest x-ray
<br>
<br> 7. Left ventricular ejection fraction (LVEF) >50% by transthoracic echocardiography
<br>
<br> 8. Zva >3.5 as calculated from TTE (transthoracic echocardiogram).
<br>
<br> 9. Hemoglobin/Hematocrit within normal laboratory standards
<br>
<br> 10. Thyroid-stimulating hormone (TSH) within normal laboratory standards
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Active pregnancy (negative pregnancy test is the standard of care prior to HUTT)
<br>
<br> 2. Demonstrate a primary cause of appropriate DOE and sinus tachycardia
<br>
<br> 1. Fevers/infection
<br>
<br> 2. Hypovolemia
<br>
<br> 3. Anemia
<br>
<br> 4. Hyperthyroidism
<br>
<br> 5. Alcohol/drug/medication withdrawal
<br>
<br> 3. Currently taking beta blocker medications
<br>
<br> 4. Currently being treated for pre-existing neurally mediated hypotension/syncope or
<br> known dysautonomia.
<br>
<br> 5. Medical history of chronic lung disease or reactive airway syndrome.
<br> | | Tachycardia;Dyspnea;Post-Acute Sequelae of COVID-19 (PASC)→Tachycardia;Dyspnea;COVID-19 | Drug: Metoprolol Succinate | Change in 6 minute walk test at the end of treatment period;Change in Zva measurement at the end of treatment period | | | | Yes | False | | |
| → | NCT05097664 | 1 November 2021→8 November 2021 | Ocular Manifestation and Related Risk Factors of Covid-19 Associated Mucormycosis: a Multicenter Study in Iran | Ocular Manifestation and Related Risk Factors of Covid-19 Associated Mucormycosis: a Multicenter Study in Iran | | Isfahan University of Medical Sciences | 23/10/2021 | 20211023 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05097664 | Recruiting | No | N/A | N/A | All | August 23, 2021 | 250 | Observational | | | Iran, Islamic Republic of | ; ; | Mohsen Pourazizi, M.D.;Mohsen Pourazizi, M.D.;Mohsen Pourazizi | | ;m.pourazizi@med.mui.ac.ir;m.pourazizi@yahoo.com | ;00983134452036;+98 | Isfahan Eye Research Center; |
<br> Inclusion Criteria:
<br>
<br> - Diagnosed case of Mucormycosis in COVID-19 pandemic
<br>
<br> Exclusion Criteria:
<br>
<br> - People with acute or severely ill conditions that prevent them from ophthalmic
<br> examination.
<br>
<br> - Patient, or legal representative opposing the pursuit of the research
<br> | | COVID-19;Mucormycosis | | Vision loss | | | | Yes | False | | |
| → | NCT05097677 | 1 November 2021→8 November 2021 | Follow-up of Covid-19 Long Term Sequelae | ORCHESTRA WP2 - Follow-up of Covid-19 Long Term Sequelae | | Azienda Ospedaliera Universitaria Integrata Verona | 16/08/2021 | 20210816 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05097677 | Recruiting | No | 14 Years | N/A | All | April 16, 2021 | 7500 | Observational [Patient Registry] | | | Belgium;Congo;France;Italy;Netherlands;Spain;Belgium;Congo;France;Italy;Netherlands;Spain | ; | Evelina Tacconelli, Professor;Evelina Tacconelli, Professor | | ;evelina.tacconelli@univr.it | ;+390458128283 | Universita di Verona; |
<br> Inclusion Criteria:
<br>
<br> - Any comorbidity
<br>
<br> - Laboratory confirmed SARS-CoV-2 infection by PCR diagnosis from nasopharynx,
<br> oropharynx, bronchoalveolar lavage, stool, or blood. Rapid tests are an acceptable
<br> alternative.
<br>
<br> - Person (or attorney or deputy who has been authorized to make the decision for
<br> patients who lack capacity) consent to participate
<br>
<br> - Person over 14 years of ages
<br>
<br> Exclusion Criteria:
<br>
<br> - Lack of consent to participate
<br>
<br> - Lack of laboratory confirmed SARS-CoV-2 infection.
<br>
<br> - Person under 14 years of ages
<br> | | COVID-19 Pneumonia;COVID-19 Respiratory Infection;COVID-19 Acute Bronchitis;COVID-19 Acute Respiratory Distress Syndrome;COVID-19 Lower Respiratory Infection;Covid19;Corona Virus Infection;Coronavirus;Coronavirus Infections;SARS-CoV2 Infection;SARS-CoV-2 Acute Respiratory Disease;SARS-Associated Coronavirus;SARS Pneumonia;SARS (Severe Acute Respiratory Syndrome);SARS (Disease);Coronavirus Pneumonia;Coronavirus Disease 2019;Coronavirus Sars-Associated | Other: Not applicable (observational study) | Clinical assessments of COVID-19 sequelae;Laboratory assessments of COVID-19 sequelae;Radiological assessments of COVID-19 sequelae;Length of COVID-19 sequelae;Association between SARS-CoV-2 variants and COVID-19 sequelae;Association between immunological patterns and COVID-19 sequelae;COVID-19 reinfections;Patterns of intestinal microbiome after SARS-CoV-2 infection;Patterns of pulmonary microbiome after SARS-CoV-2 infection;Human and viral genetic markers related to disease severity | | | | Yes | False | | |
| +++ | NCT05102084 | 8 November 2021 | The Effect Of Music On Compliance Of Patients In COVID-19 Intensive Care Unit With CPAP Device | The Effect Of Music On Compliance Of Patients In COVID-19 Intensive Care Unit With CPAP Device | | SÜMEYYE BILGILI | 20/10/2021 | 20211020 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05102084 | Recruiting | No | 18 Years | N/A | All | July 1, 2021 | 35 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | Turkey | ; ; | Reva Balci Akpinar, Prof. dr;Sümeyye Bilgili;Elif ÇADIRCI, Prof.dr | | ;smeyyebilgili@gmail.com;ecadirci@atauni.edu.tr | ;+90 506 175 93 71;+90 442 344 8719 | https://avesis.atauni.edu.tr/reva; |
<br> Inclusion Criteria:
<br>
<br> 1. over 18 years old
<br>
<br> 2. Received CPAP treatment for 1 day in the intensive care unit,
<br>
<br> 3. Not hearing impaired,
<br>
<br> 4. No sedation treatment
<br>
<br> 5. Not diagnosed with a psychiatric illness,
<br>
<br> 6. Hemodynamically stable,
<br>
<br> 7. Not taking drugs (such as digoxin, adrenaline, dopamine) that affect blood pressure
<br> and pulse rate
<br>
<br> 8. Patients with a Glasgow Coma Scale score of 11 and above will be accepted.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. The patient's desire to leave the study
<br>
<br> 2. be under the age of 18
<br>
<br> 3. putting the patient on mechanical ventilation
<br>
<br> 4. have a hearing impairment
<br>
<br> 5. Receiving sedation therapy
<br>
<br> 6. diagnosed with psychiatric illness
<br>
<br> 7. Using drugs (such as digoxin, adrenaline, dopamine) that affect blood pressure and
<br> pulse rate
<br>
<br> 8. Patients with a Glasgow Coma Scale score below 11 will not be included in the study.
<br> | | COVID-19;COVID-19 Acute Respiratory Distress Syndrome | Device: Listening to music with a bluetooth headset to patients receiving CPAP support | Patient follow-up form | | | | Yes | False | | |
| +++ | NCT05102643 | 8 November 2021 | A Study to Evaluate Safety & Immunogenicity of SARS-CoV-2 DNA Vaccine Delivered Intramuscularly Followed by Electroporation for COVID-19 | A Phase 1, Randomized, Double-blinded, Placebo-controlled, Dose-escalation Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 DNA Vaccine Delivered Intramuscularly Followed by Electroporation for COVID-19 in Healthy Adults | | The University of Hong Kong | 29/10/2021 | 20211029 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05102643 | Not recruiting | No | 18 Years | 55 Years | All | November 2021 | 30 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1 | | ; | Ivan Fan-ngai Hung;Volunteer Resource Centre | | ;ctcvrc@hku.hk | ;85296812309 | The University of Hong Kong; |
<br> Inclusion Criteria:
<br>
<br> 1. Informed Consent: The subject (or the subject's legally acceptable representative, if
<br> applicable) must be capable of giving written informed consent and, prior to the
<br> commencement of any study-specific procedure, must sign an ICF indicating the consent
<br> on the subject's voluntary participation in the study and compliance with the
<br> requirements and restrictions listed on the ICF.
<br>
<br> 2. Gender and Age: Male or female, at the age of = 18 and = 55 on the day of signing the
<br> ICF.
<br>
<br> 3. Body Weight and BMI: Body weight = 50 kg and BMI = 18.5 kg/m2 and < 25 kg/m2 at
<br> screening and baseline.
<br>
<br> 4. Medical Conditions or Diagnoses: Existence of all of the following medical conditions
<br> or diagnoses:
<br>
<br> 1. Generally in good health with no clinically significant abnormality, as
<br> determined by medical history, physical examination, 12-lead ECG and clinical
<br> laboratory tests at screening and baseline;
<br>
<br> 2. Normal vital signs at screening and baseline, as defined by:
<br>
<br> - Body (tympanic) temperature = 37.5oC;
<br>
<br> - Resting pulse rate = 50 and = 100 bpm; and
<br>
<br> - DBP = 50 and = 90 mmHg and SBP = 90 and = 140 mmHg.
<br>
<br> 5. Contraception: Willingness and agreement to undertake measures to avoid pregnancy of
<br> the subject or the subject's sexual partner(s) as detailed below:
<br>
<br> 1. A female subject who is a woman of childbearing potential (WOCBP) must be willing
<br> and agree to remain abstinent or practise at least one effective contraceptive
<br> method from at least 30 days prior to the first vaccination until 60 days after
<br> the second vaccination;
<br>
<br> 2. A male subject (i) who is sexually active with a WOCBP (except who is permanently
<br> sterile by bilateral orchiectomy or vasectomy) must be willing and agree to
<br> remain abstinent or practise at least one effective contraceptive method from the
<br> first vaccination until 60 days after the second vaccination; and (ii) must be
<br> willing and agree to refrain from sperm donation during the aforesaid period.
<br>
<br> 6. Breastfeeding: A female subject must be willing and agree to avoid engagement in
<br> breastfeeding at any time from the first vaccination until 60 days after the second
<br> vaccination.
<br>
<br> 7. Blood Donation: Willingness and agreement to avoid blood donation from screening to
<br> the end of the period of participation in this study.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Medical History: History of any of the following diseases or conditions:
<br>
<br> 1. COVID-19;
<br>
<br> 2. SARS;
<br>
<br> 3. Any significant respiratory diseases (e.g. COPD, asthma);
<br>
<br> 4. Any significant cardiovascular disease (e.g. angina, cardiac arrhythmias);
<br>
<br> 5. Blood dyscrasias or any significant disorder of coagulation;
<br>
<br> 6. Any chronic liver disease (e.g. autoimmune hepatitis and cirrhosis);
<br>
<br> 7. Any chronic infection (e.g. hepatitis B, hepatitis C and HIV);
<br>
<br> 8. Any malignant neoplastic disease;
<br>
<br> 9. Encephalopathy, neuropathy or unstable central nervous system (CNS) pathology;
<br>
<br> 10. Any psychiatric disorder, psychotic disorder, major affective disorder or
<br> suicidal ideation;
<br>
<br> 11. Any immunodeficiency or autoimmune disease;
<br>
<br> 12. Any severe allergic reaction (e.g. anaphylaxis) to any vaccine or substance,
<br> which requires hospitalization or emergency medical care;
<br>
<br> 13. History of alcohol or illicit drug abuse, or used any illicit drug within 6
<br> months prior to screening.
<br>
<br> 2. Medical Conditions or Diagnoses: Existence of any of the following medical conditions
<br> or diagnoses:
<br>
<br> 1. Positive serum pregnancy test at screening or positive urine pregnancy test at
<br> baseline (for WOCBP);
<br>
<br> 2. IgE level > 1,000 IU/ml at screening;
<br>
<br> 3. Positive SARS-CoV-2 test result in serum or deep throat saliva (DTS) within 4
<br> days prior to baseline;
<br>
<br> 4. T3, T4 or TSH < LLN or > ULN at screening;
<br>
<br> 5. Positive HIV test result at screening;
<br>
<br> 6. Positive HBsAg test result at screening;
<br>
<br> 7. Positive HCV antibody test result at screening;
<br>
<br> 8. Positive urine drug screen test result or positive blood alcohol test result at
<br> screening or baseline;
<br>
<br> 9. Any clinically significant findings (e.g. active or acute cardiac/pulmonary
<br> diseases) from chest X-ray examination performed at or within 4 months prior to
<br> screening.
<br>
<br> 3. Prior/Concomitant Interventions: Use of or undergoing any of the following prior or
<br> concomitant medications, therapies or interventions:
<br>
<br> 1. Any COVID-19 or coronavirus vaccine at any time prior to the first vaccination,
<br> or planned use of any such vaccine throughout the study;
<br>
<br> 2. Any vaccine other than COVID-19 or coronavirus vaccines within 28 days prior to
<br> the first vaccination, or planned use of any such vaccine up to 28 days after the
<br> second vaccination;
<br>
<br> 3. Any immune-modifying medication/therapy (e.g. immunomodulator and
<br> immunosuppressant) within 6 months prior to the first vaccination, or planned use
<br> of any such medication/therapy throughout the study;
<br>
<br> 4. Any blood product (including blood transfusion) or immunoglobulin within 3 months
<br> prior to the first vaccination, or planned use of any such therapy throughout the
<br> study;
<br>
<br> 5. Any anticoagulation medication within 28 days prior to the first vaccination, or
<br> planned use of any such medication up to 28 days after the second vaccination;
<br>
<br> 6. Any psychotropic medication within 28 days prior to the first vaccination, or
<br> planned use of any such medication up to 28 days after the second vaccination;
<br>
<br> 7. Regular use of any topical corticosteroids at or near the intended administration
<br> site (upper arm);
<br>
<br> 8. Any influenza antiviral medication within 48 hours prior to the first
<br> vaccination, or planned use of any such medication up to 14 days after the second
<br> vaccination;
<br>
<br> 9. Any prescription or over-the-counter medication or supplement product (e.g.
<br> vitamin, dietary supplement, herbal preparation) within 7 days prior to the first
<br> vaccination, unless with the investigator's approval for managing a chronic
<br> condition;
<br>
<br> 10. Donated = 450 ml of blood within 28 days prior to the first vaccination.
<br>
<br> 4. Prior/Concurrent Clinical Study: Prior or concurrent participation in any other
<br> | | Covid19 | Biological: SARS-CoV-2 DNA Vaccine;Biological: Matching placebo | Reactogenicity;Adverse Events | | | | Yes | False | | |
| +++ | NCT05102656 | 8 November 2021 | Patient Perceptions of the Relational Empathy of Healthcare Practitioners From the Department of Emergency Medicine During the COVID-19 Pandemic | Patient Perceptions of the Relational Empathy of Healthcare Practitioners From the Department of Emergency Medicine During COVID-19: A Randomized, Controlled Trial Comparing In-Person Interaction With Personal Protective Equipment (PPE) Versus Video Interaction Without PPE | | M.D. Anderson Cancer Center | 29/10/2021 | 20211029 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05102656 | Recruiting | No | 18 Years | N/A | All | June 2, 2021 | 106 | Observational | | | United States | ; ; | Kumar Alagappan;Kumar Alagappan;Kumar Alagappan | | ;KAlagappan@mdanderson.org;KAlagappan@mdanderson.org | ;713-745-9911;713-745-9911 | M.D. Anderson Cancer Center; |
<br> Inclusion Criteria:
<br>
<br> - >= 18 years old
<br>
<br> - Able to speak and write in English
<br>
<br> - Able to understand and willing to sign a written informed consent document
<br>
<br> - Willing and able to complete the study assessment(s)
<br>
<br> Exclusion Criteria:
<br>
<br> - Refuses to participate
<br>
<br> - Too ill to participate, in the estimation of the patient's physician
<br> | | COVID-19 Infection;Hematopoietic and Lymphoid Cell Neoplasm;Malignant Solid Neoplasm | Other: Best Practice;Procedure: Discussion;Other: Questionnaire Administration | Patients' perceptions of healthcare provider empathy | | | | Yes | False | | |
| +++ | NCT05102695 | 8 November 2021 | Study of CRP, Ferritine and D-Dimer in Covid-19 Patients Admitted To Respiratory ICU in Assuit University Hospitals | Study of CRP, Ferritine and D-Dimer in Covid-19 Patients Admitted To Respiratory ICU in Assuit University Hospitals | | Assiut University | 28/10/2021 | 20211028 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05102695 | Not recruiting | No | 18 Years | 80 Years | All | January 1, 2022 | 160 | Observational | | | | | Mina Ibraheem Anis, Resident | | minaibraheem11@yahoo.com | 01015323474 | |
<br> Inclusion Criteria:
<br>
<br> - -Cases aged 18 years and over. -Cases diagnosed as COVID-19 by radiology or with
<br> positive PCR. -Cases admitted to Assuit University Hospitals.
<br>
<br> Exclusion Criteria:
<br>
<br> - -Cases less than 18 Years old. -Cases Diagnosed as COVID-19 and Discharged from
<br> emergency department for home isolation. -Cases who refused the use of their data.
<br> | | Covid19 | Diagnostic Test: Serum CRP , ferritine and d-dimer | Correlation between results and outcome of the patients | | | | Yes | False | | |
| +++ | NCT05104333 | 8 November 2021 | Evaluation of Immunogenicity, Safety and Antibody Persistence of COVID-19 Booster Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes | A Post-marketing Clinical Study of a Third Dose of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Beijing): Immunogenicity, Safety and Antibody Persistence Assessments in Patients With Hypertension and/or Diabetes | | China National Biotec Group Company Limited | 30/10/2021 | 20211030 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104333 | Not recruiting | No | 60 Years | N/A | All | November 2021 | 1440 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). | Phase 4 | China | | FangJun LI | | ymlc05@hncdc.com | +86-13574109585 | |
<br> Inclusion Criteria:
<br>
<br> - Participate in the clinical trial "NCT05065879".
<br>
<br> - =60 years old individuals with full civil capacity.
<br>
<br> - Clinically confirmed body temperature of <37.3°C before enrolling in this study.
<br>
<br> - Able and willing to participate in the study plan during the entire study and
<br> follow-up period.
<br>
<br> - Capable of understanding the study procedures, willing to sign the informed consent
<br> form, and able to comply with the requirements of the clinical study protocol.
<br>
<br> - Inclusion criteria for patients with hypertension and/or diabetes: Hypertension and/or
<br> diabetes definitively diagnosed by a community-level or higher medical institution.
<br> Patients with hypertension: systolic pressure <160 mmHg and diastolic pressure <100
<br> mmHg on the day of immunization achieved by lifestyle adjustment and/or drug
<br> treatment; patients with diabetes: fasting glucose =13.9 mmol/L on the day of (or
<br> within 3 days before) immunization achieved by lifestyle adjustment and/or drug
<br> treatment
<br>
<br> Exclusion Criteria:
<br>
<br> - Previously confirmed or asymptomatic COVID-19 patient.
<br>
<br> - Has been immunized with a SARS-CoV-2 vaccine.
<br>
<br> - Illiterate.
<br>
<br> - Known allergy to any ingredient (including excipient) of this product.
<br>
<br> - Received non-specific immunoglobulin injection within 1 month before enrollment.
<br>
<br> - Received a live attenuated vaccine within 1 month before immunization or other vaccine
<br> within 14 days before immunization.
<br>
<br> - Previous serious allergy to vaccine (e.g., acute allergic reaction, urticaria,
<br> angioedema, and dyspnea).
<br>
<br> - Has uncontrolled epilepsy and other progressive neurological disorders; history of
<br> Guillain-Barré syndrome.
<br>
<br> - Severe respiratory disorders, severe hepatic and renal diseases, malignancies, and
<br> various acute diseases or acute onset of chronic diseases.
<br>
<br> - Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma,
<br> leukemia, or other autoimmune diseases.
<br>
<br> - Definitively diagnosed with thrombocytopenia or history of other coagulation disorders
<br> that may cause subcutaneous injection to be contraindicated.
<br>
<br> - Currently experiencing acute complications (ketoacidosis, hyperosmolar state, lactic
<br> acidosis, etc.) of diabetes; or within 2 weeks after recovery from these
<br> complications.
<br>
<br> - Other physical conditions judged by the investigator that render the patient
<br> unsuitable for participation in the clinical study.
<br> | | COVID-19 Pneumonia | Biological: Covid-19 vaccine (0-1-4 schedule);Biological: Covid-19 vaccine (0-1-6 schedule) | Neutralizing antibody level;Neutralizing antibody level;Neutralizing antibody level;Neutralizing antibody level;Neutralizing antibody level;Seroconversion rate | | | | Yes | False | | |
| +++ | NCT05104398 | 8 November 2021 | Hemoperfusion With the Efferon CT Extracorporeal Adsorbers in Patients With Severe Covid-19 | Hemoperfusion With the Efferon CT Extracorporeal Adsorbers Containing Mesoporous Styrene-divinylbenzene Copolymer in Patients With Severe Covid-19 | | Efferon JSC | 31/10/2021 | 20211031 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104398 | Not recruiting | No | 18 Years | 81 Years | All | October 1, 2020 | 42 | Observational | | | Russian Federation | | Timur Kim, MD | | | | N.I. Pirogov Clinical City Hospital No. 1 |
<br> Inclusion Criteria:
<br>
<br> - Men and women aged 21-80,
<br>
<br> - Primary ICU patients (admitted to the hospital, transfer from another hospital or
<br> department less than 72 hours),
<br>
<br> - Positive PCR test for SARS-CoV-2,
<br>
<br> - PaO2 / FiO2 <300,
<br>
<br> - SOFA = 4 with clinic of organ dysfunction.
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnancy,
<br>
<br> - The presence of signs of a bacterial infection or the addition of secondary
<br> purulent-septic complications,
<br>
<br> - Cancer (including blood diseases),
<br>
<br> - Chronic diseases in the stage of decompensation,
<br>
<br> - Recent or ongoing bleeding,
<br>
<br> - Syndrome of disseminated intravascular coagulation,
<br>
<br> - Thrombocytopenia,
<br>
<br> - Patients in terminal condition or receiving palliative care,
<br>
<br> - Patients for whom, for any reason, the use of anticoagulants is not safe.
<br> | | COVID-19 | Device: Efferon CT | Effect of Efferon CT hemoperfusion on pulmonary oxygen metabolism function | | | | No | False | | |
| +++ | NCT05104424 | 8 November 2021 | The Study of Quadruple Therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation for Post COVID-19 Smell and Taste Dysfunctions | The Study of Quadruple Therapy Intranasal Insulin, Zinc, Gabapentin, Ice Cube Stimulation for Post Covid-19 Smell and Taste Dysfunctions | COVID-19 | Ministry of Health, Saudi Arabia | 25/10/2021 | 20211025 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104424 | Not recruiting | No | 18 Years | 75 Years | All | December 26, 2021 | 22 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | | | Amr Ahmed | | drmedahmed@gmail.com | +966597310032 | |
<br> Inclusion Criteria:
<br>
<br> - adult male or female recovered patients only postcovid-19 no other interventional
<br> treatment
<br>
<br> Exclusion Criteria:
<br>
<br> less than 18 years any nasal deviation or congenital anomalies any allergic sinusitis or
<br> nasal problems pregnant women's
<br>
<br> -
<br> | | Smell Dysfunction;Taste Disorders;Taste Disorder, Secondary, Sweet;Taste Disorder, Secondary, Bitter;Smell Disorder | Drug: Insulin aspart | evaluation of disturbances of smell and taste (Sniffin 'Sticks" test);evaluation of taste disorders;questionnaire for taste self assessment ( Dynachron-olfaction questionnaire) | | | | Yes | False | | |
| +++ | NCT05104437 | 8 November 2021 | Evaluation of Immunogenicity, Safety and Antibody Persistence of COVID-19 Booster Vaccine (Produced in Wuhan) in Patients With Hypertension and/or Diabetes | A Post-marketing Clinical Study of a Third Dose of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Wuhan): Immunogenicity, Safety and Antibody Persistence Assessments in Patients With Hypertension and/or Diabetes | | China National Biotec Group Company Limited | 30/10/2021 | 20211030 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104437 | Not recruiting | No | 60 Years | N/A | All | November 2021 | 1440 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Outcomes Assessor). | Phase 4 | China | | Ruizhi ZHANG | | 919987774@qq.com | +86-13985441115 | |
<br> Inclusion Criteria:
<br>
<br> - Participate in the clinical trial "NCT05065892".
<br>
<br> - =60 years old individuals with full civil capacity.
<br>
<br> - Clinically confirmed body temperature of <37.3°C before enrolling in this study.
<br>
<br> - Able and willing to participate in the study plan during the entire study and
<br> follow-up period.
<br>
<br> - Capable of understanding the study procedures, willing to sign the informed consent
<br> form, and able to comply with the requirements of the clinical study protocol.
<br>
<br> - Inclusion criteria for patients with hypertension and/or diabetes: Hypertension and/or
<br> diabetes definitively diagnosed by a community-level or higher medical institution.
<br> Patients with hypertension: systolic pressure <160 mmHg and diastolic pressure <100
<br> mmHg on the day of immunization achieved by lifestyle adjustment and/or drug
<br> treatment; patients with diabetes: fasting glucose =13.9 mmol/L on the day of (or
<br> within 3 days before) immunization achieved by lifestyle adjustment and/or drug
<br> treatment
<br>
<br> Exclusion Criteria:
<br>
<br> - Previously confirmed or asymptomatic COVID-19 patient.
<br>
<br> - Has been immunized with a SARS-CoV-2 vaccine.
<br>
<br> - Illiterate.
<br>
<br> - Known allergy to any ingredient (including excipient) of this product.
<br>
<br> - Received non-specific immunoglobulin injection within 1 month before enrollment.
<br>
<br> - Received a live attenuated vaccine within 1 month before immunization or other vaccine
<br> within 14 days before immunization.
<br>
<br> - Previous serious allergy to vaccine (e.g., acute allergic reaction, urticaria,
<br> angioedema, and dyspnea).
<br>
<br> - Has uncontrolled epilepsy and other progressive neurological disorders; history of
<br> Guillain-Barré syndrome.
<br>
<br> - Severe respiratory disorders, severe hepatic and renal diseases, malignancies, and
<br> various acute diseases or acute onset of chronic diseases.
<br>
<br> - Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma,
<br> leukemia, or other autoimmune diseases.
<br>
<br> - Definitively diagnosed with thrombocytopenia or history of other coagulation disorders
<br> that may cause subcutaneous injection to be contraindicated.
<br>
<br> - Currently experiencing acute complications (ketoacidosis, hyperosmolar state, lactic
<br> acidosis, etc.) of diabetes; or within 2 weeks after recovery from these
<br> complications.
<br>
<br> - Other physical conditions judged by the investigator that render the patient
<br> unsuitable for participation in the clinical study.
<br> | | COVID-19 Pneumonia | Biological: Covid-19 vaccine (0-1-4 schedule);Biological: Covid-19 vaccine (0-1-6 schedule) | Seroconversion rate;Neutralizing antibody level;Neutralizing antibody level;Neutralizing antibody level;Neutralizing antibody level;Neutralizing antibody level | | | | Yes | False | | |
| +++ | NCT05104489 | 8 November 2021 | Dose-finding Study for AdimrSC-2f Vaccine | A Phase I/II, Placebo-Controlled, Randomized, Double-Blind, Dose-Finding Study to Evaluate the Safety, Tolerability, and Immunogenicity of AdimrSC-2f Vaccine in Healthy Adults | | Adimmune Corporation | 04/10/2021 | 20211004 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104489 | Not recruiting | No | 18 Years | 60 Years | All | December 2021 | 240 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | Indonesia | | Tzu-Lan Liu | | tzulan_liu@enimmune.com.tw | +886-2-27093833 | |
<br> Inclusion Criteria:
<br>
<br> 1. Subjects aged 18 to 60 years old (inclusive) at the time of informed consent who are
<br> in good general health in the opinion of the investigator.
<br>
<br> 2. At Screening Visit, subjects with a body mass index (BMI) > 18.5 kg/m2 or = 30.0
<br> kg/m2.
<br>
<br> 3. Subjects without known history of SARS-CoV-2 infection or known close contact with
<br> anyone with laboratory-confirmed SARS-CoV-2 infection or COVID-19 within 2 weeks prior
<br> to the first dosing.
<br>
<br> 4. Subjects are willing and able to give informed consent prior to any screening
<br> procedure conducting and to comply with study procedures.
<br>
<br> 5. Female subjects of childbearing potential (defined as any female who has experienced
<br> menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal
<br> ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least
<br> 12 consecutive months or documented plasma follicle-stimulating hormone level =40
<br> milli-International unit (mIU)/mL]) must agree to be heterosexually inactive from at
<br> least 21 days prior to the Screening Visit and through 6 months (defined as 24 weeks)
<br> after the last dosing OR agree to consistently use any of the following methods of
<br> contraception from at least 21 days prior to the Screening Visit and through 6 months
<br> (defined as 24 weeks) after the last dosing:
<br>
<br> - Condoms (male or female) with spermicide (if acceptable in country)
<br>
<br> - Diaphragm with spermicide
<br>
<br> - Cervical cap with spermicide
<br>
<br> - Intrauterine device
<br>
<br> - Oral or patch contraceptives
<br>
<br> - Norplant®, Depo-Provera®, or other in country regulatory-approved contraceptive
<br> method that is designed to protect against pregnancy
<br>
<br> - Abstinence, as a form of contraception, is acceptable
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subjects who are investigational site staff member directly involved in the conduct of
<br> the trial and their family members, site staff members otherwise supervised by the
<br> Investigator, or subjects who are Sponsor employees directly involved in the conduct
<br> of the trial.
<br>
<br> 2. Any ongoing severe acute or chronic medical or psychiatric condition or laboratory
<br> abnormality that may increase the risk associated with study participation or
<br> investigational product administration or may interfere with the interpretation of
<br> study results and, in the judgment of the investigator, would make the subject
<br> inappropriate for entry into this study.
<br>
<br> 3. Subject with positive serology test results for human immunodeficiency virus (HIV),
<br> hepatitis C virus (HCV) or hepatitis B virus (HBV) at the Screening Visit (V0).
<br>
<br> 4. Subject with positive test result for COVID-19 antigen rapid test at the Screen Visit
<br> or V1 prior to the 1st dosing.
<br>
<br> 5. Subject with influenza-like illness as defined by any of the following symptoms at the
<br> Screening Visit or before randomization: fever (tympanic temperature = 38°C), dry
<br> cough, headache, fatigue, respiratory sputum production (phlegm), dysgeusia, anosmia,
<br> shortness of breath, muscle and joint pain, or sore throat.
<br>
<br> 6. Participation in other studies involving investigational drug(s) and/or device(s)
<br> within 90 days prior to the Screening Visit and/or during study participation.
<br>
<br> 7. Subject who has received any investigational coronavirus vaccine or has received any
<br> medications intended to prevent COVID-19 or plan simultaneous participation in another
<br> interventional study to prevent or treat COVID-19.
<br>
<br> 8. Subject with any following ongoing disease or medical history in medical chart or by
<br> verbal confirmation:
<br>
<br> - Diagnosis of malignancy not in remission for the past 3 years except non-melanoma
<br> skin cancer prior to the Screening Visit.
<br>
<br> - Chronic pulmonary disease, asthma or wheezing.
<br>
<br> - Chronic liver disease or suspected active hepatitis.
<br>
<br> - Clinically significant cardiovascular disease such as arrhythmia, coronary artery
<br> disease or heart failure.
<br>
<br> - Personal or family history of immune disorders, including systemic lupus
<br> erythematosus (SLE), rheumatoid arthritis, multiple sclerosis, inflammatory bowel
<br> disease, and Type 1 diabetes.
<br>
<br> - Any confirmed or suspected abnormal immune function, immunosuppressive, or
<br> immunodeficiency.
<br>
<br> - Personal or family history of Guillain-Barré Syndrome.
<br>
<br> - Bleeding diathesis or condition associated with prolonged bleeding.
<br>
<br> - History of anaphylaxis, urticarial or severe adverse reaction associated with a
<br> vaccine or AdimrSC-2f or aluminum.
<br>
<br> - Dermatologic conditions that could affect local solicited adverse event
<br> assessment per the investigator's opinion.
<br>
<br> 9. Subject who has any of the following prior medication histories:
<br>
<br> - Received any vaccine (live, inactivated, or bacterial) within 30 days prior to
<br> the Screening Visit.
<br>
<br> - Received any blood/plasma products or immunoglobulin within 90 days prior to the
<br> Screening Visit.
<br>
<br> - Received any systemic corticosteroids or steroids within 30 days prior to the
<br> first dosing. Topical, inhaled/nebulized, intra-articular, or nasal
<br> corticosteroid/ steroids are permitted.
<br>
<br> - Received treatment with immunosuppressive therapy, including cytotoxic agents,
<br> immunosupressants or system corticosteroids for organ transplant, cancer, or an
<br> autoimmune disease, or planned receipt for disease treatment during study period.
<br>
<br> - Used bronchodilator within 90 days prior to the Screening visit.
<br>
<br> 10. Subject with current use or history of chronic smoking (defined as = 1 cigarette per
<br> day) in the medical chart or by verbal confirmation within 1 year prior to the
<br> Screening Visit.
<br>
<br> 11. Subject with the history of illegal substance use or alcohol abuse in the medical
<br> chart or by verbal confirmation within 2 years prior to the Screening Visit.
<br>
<br> 12. Female subject who is pregnant or lactating at the Screening Visit or Visit 1 or plan
<br> to be pregnant during the study period.
<br>
<br> 13. Subject who has donated = 250 mL of blood product within 28 days prior to the
<br> Screening Visit or who plans to donate blood products during the study period.
<br>
<br> 14. Subject with levels of creatine phosphokinase outside of the reference range at the
<br> Screening Visit.
<br>
<br> 15. Subject who is not suitable to participate in this study as judged by the
<br> investigator.
<br> | | COVID-19 | Biological: AdimrSC-2f | SARS-CoV-2 neutralizing antibody tiers;Incidence of adverse events and clinically significant changes in clinical and laboratory evaluations. | | | | Yes | False | | |
| +++ | NCT05109065 | 8 November 2021 | Peripheral Immune System in Individuals With Schizophrenia | Peripheral Immune System in Individuals With Schizophrenia | | Stanford University | 26/10/2021 | 20211026 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05109065 | Recruiting | No | 18 Years | 40 Years | All | March 1, 2021 | 100 | Observational | | | United States | ; ; | Agnes Kalinowski, MD/PhD;Diane E Wakeham, PhD;Diane E Wakeham, PhD | | ;wakeham@stanford.edu;wakeham@stanford.edu | ;650-721-4413;650-721-4413 | Clinical Professor of Psychiatry and Behavior Sciences; |
<br> Inclusion Criteria for Subjects with schizophrenia and schizoaffective disorders:
<br>
<br> - Schizophrenia or schizoaffective disorder diagnosis verified by interview
<br>
<br> - Diagnosis or initiation of antipsychotic medication was within last 5 years
<br>
<br> Inclusion Criteria for Healthy Controls:
<br>
<br> - No known diagnosis of schizophrenia or schizoaffective disorder
<br>
<br> - No history of depression, anxiety, bipolar disorder, PTSD, agoraphobia, panic
<br> disorder, or generalized anxiety disorder
<br>
<br> - Negative assessment for psychotic symptoms on day of interview
<br>
<br> Exclusion Criteria (for both groups):
<br>
<br> - Participants have a history of bleeding disorders or are taking blood thinners.
<br>
<br> - Participants have a history of epilepsy, known genetic disorders
<br>
<br> - Immunocompromised state (eg., receiving immunosuppressive therapy, transplant).
<br>
<br> - History of brain-related disease (eg., stroke)
<br>
<br> - Any uncontrolled medical disorder such as cancer.
<br>
<br> - History of substance abuse or positive urine toxicology screen (including test for
<br> marijuana) on the day of the blood draw
<br> | | Schizophrenia;Schizo Affective Disorder;Schizophreniform Disorders | Diagnostic Test: SCID (Standardized Clinical Interview for DSM-V);Diagnostic Test: PSS (Perceived Stress Score);Diagnostic Test: Urine Toxicology Screen;Diagnostic Test: Vitals;Diagnostic Test: Blood Work;Diagnostic Test: PQ-B;Diagnostic Test: COVID Screening | Group comparison of C4 protein in PBMCs | | | | Yes | False | | |
| → | ACTRN12621001254886 | 20 September 2021→8 November 2021 | I’ll be OK In Year 7: Effects of the 8 week transition programs on Year 6 students' psychological well-being and successful transition to Year 7, during the COVID-19 pandemic. | I’ll be OK In Year 7: Effects of the 8 week transition programs on adolescents' mental health, well-being and transition to high-school, during the COVID-19 pandemic (Stage 1 )
| | Australian Catholic University | 16/09/2021 | 20210916 | ANZCTR | https://anzctr.org.au/ACTRN12621001254886.aspx | Not Recruiting | No | 11 Years | 12 Years | Both males and females | 11/10/2021 | 300 | Interventional | Purpose: Educational / counselling / training; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Efficacy; | Not Applicable | Australia | | | | | | | Inclusion criteria: Participants will include 300 Year 6 students (age 11-12) from 6 mainstream primary schools; (public and non-public schools) located in Sydney Inner West..
<br>Participants need to be enrolled in Year 6 in 2021
<br> | Exclusion criteria: No participants will be excluded, unless parents/guardians do not consent.
<br>Selective schools will not be included | anxiety;depression;stress; <br>anxiety <br>depression <br>stress;Mental Health - Anxiety;Mental Health - Depression;Mental Health - Studies of normal psychology, cognitive function and behaviour | SBTIMH Stage 1 is a two arm intervention trial with no control group, involving 2 intervention groups (A & B). 300 Year 6 students from 6 primary schools will be exposed to 2 different interventions.<br>Group A (n=150) will participate in the 8 week (one-hour), school based - Resilience Focused Transition Program (RFTP); delivered by provisional psychologists under supervision of the registered psychologist /Board of Psychology' approved supervisor.<br>Group B (n=150) will participate in 8 week (one-hour), school based - Mindfulness Focused Transition Program (MFTP), delivered by provisional psychologists under supervision of the applicant, who, in addition to psychology, is also a certified mindfulness facilitator.<br>Children/Year 6 students will participate in 8 one-hour per week sessions, during school term, delivered in their own class, with their classroom teacher present. The activities will involve skill development, role plays, discussion and completing quizzes and questionnaires.<br>Session attendance checklists will be used to monitor adherence to the intervention.<br>Sessions will be delivered face to face or via Zoom, subject to current COVID -19 restrictions.<br>The following contents will be included in the proposed programs:<br>Program A <br>"I'll be OK in Year 7" Resilience Focused Transition Program- Proposed Outline (2021)<br>Week 1 (90 min) Introduction to the Program <br>- Introducing the program, presenters and participants<br>- Discussing goals of the program & group rules<br>- Exploring feelings about transition to High School<br>- Completion of Year 6 Surveys- Homework<br>Week 2 (60 min) Coping with changes<br>- What is transition stress<br>- Discussing how to cope with change, and building resilience <br>- Stress reduction activity<br>Week 3 | Child Behaviour measured by scores on Strength and Difficulties Questionnaire (SDQ-P), completed by a parent.<br><br><br>[T-1 Pre intervention (Week 1) <br>T-2 Post intervention (Week 8)- primary timepoint<br>T-3 Follow up (12 month post-completion of intervention)];Composite Mental Health Outcomes (anxiety, depression, stress) measured by DASS-Y <br>Youth Depression, Anxiety and Stress Scale -DASS-Y scores<br>The DASS -Y is an unpublished child/adolescent adaptation of DASS-21 a widely used and validated measure of depression, anxiety and stress symptoms in general Australian populations. [T-1 Pre intervention (Week 1) <br>T-2 Post intervention (Week 8)- primary timepoint<br>T-3 Follow up (12 month post-completion of intervention)] | | | | Yes | False | | |
| +++ | ACTRN12621001492842 | 8 November 2021 | COVID-19 vaccination of vulnerable populations (COVULPOP) | Profiling the immune response to COVID-19 vaccination in vulnerable populations (COVULPOP). | | Prof Katie Flanagan | 02/11/2021 | 20211102 | ANZCTR | https://anzctr.org.au/ACTRN12621001492842.aspx | Not Recruiting | No | 18 Years | No limit | Both males and females | 22/11/2021 | 40 | Interventional | Purpose: Prevention; Allocation: Non-randomised trial; | Not Applicable | Australia | | | | | | | Inclusion criteria: Younger adults: aged 18 to 45 years, healthy with no major co-morbidities .
<br>Elderly: 65 years of age or older with or without co-morbidities.
<br>Pregnant women: healthy uncomplicated pregnancy at any stage of gestation
<br>All participants:
<br>- Ability to communicate in English
<br>- Ability to communicate by mobile telephone and text messaging
<br>- Written informed consent to participate in the trial | Exclusion criteria: - Outside the specified age range
<br>- Inability to speak and/or understand English
<br>- Diagnosed with a cognitive impairment or inability to provide informed consent
<br>- Known allergy or contraindication to COVID-19 (or dTap or influenza vaccination in pregnant women)
<br>- Unwilling to give consent to participate | COVID-19 vaccine response;COVID-19; <br>COVID-19 vaccine response <br>COVID-19;Inflammatory and Immune System - Normal development and function of the immune system;Respiratory - Other respiratory disorders / diseases;Infection - Other infectious diseases | For all participants apart from pregnant women, participation will require that they are due to have a COVID-19 vaccination. Pregnant women who don’t want a COVID-19 vaccination will have the opportunity to participate at the time of their next scheduled pregnancy vaccine – either dTap, QIV or both. <br>The COVID-19 vaccine can be first dose, second dose or subsequent booster doses. If the participant has had a COVID-19 vaccine (1 or 2 doses) they will be asked to participate for their second or booster dose only. If they have not had a COVID-19 vaccination, they will be invited to provide venous blood samples for both their primary vaccinations. Vaccines will be administered intramuscularly into the deltoid muscle by a trained nurse. Participants presenting for their first dose will be offered the opportunity to provide 24hr, 1 week and 4-week samples at the time of their second doses too. <br>The study will initially focus on the Pfizer mRNA COVID-19 vaccine Comirnaty in the younger age groups since this is the preferred choice in Australia for people <60 years of age, but will test other vaccines such as the Moderna mRNA vaccine or Novavax’s spike protein vaccine once available and authorised for use in Australia. Younger people may also choose to have the AstraZeneca vaccine. Older individuals may be offered COVID-19 Vaccine AstraZeneca or Comirnaty, depending on availability, but other vaccines may also become available to them. Anyone who has a mixed schedule with 2 different vaccines for any reason (e.g. severe adverse reaction to the first vaccine, original vaccine not available, personal choice) will remain eligible for the study since there are very limited data about the effects of using mixed schedules and this will provide valuable information. <br>The sec | Measurement and comparison of the vaccine-induced humoral immune responses to COVID-19 vaccination from blood samples of pregnant women, the elderly, healthy adult men and non-pregnant women.[24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2). Cord blood will also be collected from pregnant participants at delivery.];Measurement and comparison of the vaccine-induced cellular immune responses to COVID-19 vaccination from blood samples of pregnant women, the elderly, healthy adult men and non-pregnant women.[24 hours, 1 week and 4 weeks after each primary vaccination dose (1 or 2). Cord blood will also be collected from pregnant participants at delivery.] | | | | Yes | False | | |
| → | ISRCTN16329124 | 1 November 2021→8 November 2021 | Testing an artificial intelligence hospital appointment management system | A pragmatic trial of an Artificial intelligence DRiven appOInTment maNagEment SyStem (ADROITNESS) | | London South Bank University | 29/10/2021 | 20211029 | ISRCTN | https://www.isrctn.com/ISRCTN16329124 | Recruiting | No | | | Both | 01/02/2022 | 900 | Interventional | Multicenter comparison trial utilising between-site comparators (site receiving no intervention) and within-site comparators (Treatment) | Not Applicable | United Kingdom;England | | | | | | | Inclusion criteria: <br> Patients:<br> 1. Receiving secondary care (outpatients) at intervention/comparator sites<br> 2. Aged 18 years or over<br> 3. Capacity to/and consent (4) within one of the following care streams: ophthalmology (glaucoma), renal, oncology (colorectal)<br> | Exclusion criteria: <br> Patients:<br> 1. Not receiving secondary care within at least one of the three selected specialities (ophthalmology, oncology, renal)<br> 2. Aged below 18 years<br> 3. Not attending the named intervention/comparator site<br> 4. Unable/unwilling to consent<br> | Improving appointment attendance in patients attending secondary care <br>Not Applicable | <br> The project is evaluating a new way of organising appointments, using an intervention/technology called DrDoctor.<br><br> DrDoctor is designed to reduce the number of missed appointments by providing regular electronic reminders; ways to rearrange appointments and linking appointments, for example making sure that blood tests are available before an appointment to see a doctor or a nurse. You can read more about it at https://www.drdoctor.co.uk/.<br><br> The researchers are looking to see if the new technology for organising appointments is accurate, safe, effective and takes the needs of patients into account. They are doing this by comparing hospitals that use DrDoctor with those that do not.<br><br> This study comprises a pre/post-deployment comparison trial utilising between site comparators (site receiving no intervention) and within site comparators (comprising data from 3 months prior to deployment and 6 months post-deployment). A 2-month period immediately following deployment is excluded from data-collection/evaluation to ensure the intervention/technology (DrDoctor) is functioning correctly and any emerging deployment issues are resolved. To account for service impacts caused by COVID, Trust data will also be used from the 3 months of October to December 2019. These dates were chosen because they were the 3 months prior to the COVID lockdown.<br><br> The trial will test for superiority on cost and efficiency outcomes, and non-inferiority on clinical outcomes. The null hypothesis is that no observable treatment differences will be detected.<br><br> Primary analysis (direct from participant data)<br><br> A total sample of 900 people will be sampled from a single intervention site (n=450) and | Number of Did Not Attends (DNAs) and number of unused appointments measured using Trust data at baseline (3 months prior to deployment of DrDoctor) and at 6-months post-deployment | | 01/12/2023 | | Yes | False | | |
| → | ISRCTN17785461 | 1 November 2021→8 November 2021 | Investigating point of care diagnostic strategies to optimize the rapid diagnosis of COVID-19 in routine public and private health care settings in South Africa | Investigating point of care diagnostic strategies to optimize the rapid diagnosis of COVID-19 in routine public and private health care settings in South Africa | | South African Medical Research Council | 28/10/2021 | 20211028 | ISRCTN | https://www.isrctn.com/ISRCTN17785461 | Recruiting | No | | | Both | 01/10/2020 | 1581 | Observational | Prospective observational cohort study (Screening) | Not Applicable | South Africa | | | | | | | Inclusion criteria: <br> 1. Age 18 years and older<br> 2. Has symptoms of COVID-19 and meets current NICD/NHLS case definition for testing<br> 3. Has been in close contact with a SARS-CoV-2 RT-PCR positive person (>15 minutes in a poorly ventilated space or =1 metre apart) and<br> 4. Age 18 years and older and<br> 5. Agrees to providing paired naso-pharyngeal and blood samples and<br> 6. Self-reports not feeling sick or no symptoms of COVID-19 on initial questioning<br> | Exclusion criteria: Participant does not consent to follow-up including home based follow-up | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> 1. Finger prick COVID-19 rapid test: We will prick participants and do a rapid test(s) using one or more kits for COVID-19. The rapid test result(s) can be given to participants, but it will not be participantsr final confirmed COVID-19 result because the result(s) may be wrong. participantsr true COVID-19 test result will come from RT-PCR testing in the laboratory. If participants test RT-PCR or rapid test COVID-19 positive, we will follow participants up in 5 to less than 14 days and possibly at 25-30 days, 3, 6, 9 and 12 months.<br> 2. Blood tests: We will collect approximately six teaspoons of blood at the first visit and up to six teaspoons of blood at each follow-up visit, in special tubes.<br> • At follow-up, in the Western Cape site, we will take four more teaspoons of blood to do additional tests on immune function on 100 people because the laboratory that specializes in these tests is located in the Western Cape.<br> • We will also take 4 more teaspoons of blood from a group of participants (or from all participants if budget allows), for more detailed tests to understand how the body responds to COVID-19. These additional 4 teaspoons will be used for more detailed tests to understand how the body responds to COVID-19.<br> • In summary, we could take between six and fourteen teaspoons of blood from participants at each visit if participants are in the Western Cape, and between six and ten teaspoons of blood from participants at each visit, if participants are in Limpopo and Gauteng province.<br> • It is safe to take this amount of blood. We will send specimens to the laboratory for COVID-19 testing including how the soldiers of the body (the immune system) respond to COVID-19 infecti | Performance evaluation of Point Of Care tests is conducted by comparing field based SARS-CoV-2 rapid test results to gold standard laboratory based PCR results from accredited laboratories. Rapid tests and PCR are conducted at the baseline visit and 5 - 14 day follow up visit for persons under investigation | | 30/09/2022 | | No | False | | |
| → | ISRCTN12348322 | 1 November 2021→8 November 2021 | Comparing COVID-19 vaccine schedule combinations in adolescents (Com-COV3) | A single-blind, randomised, phase II UK multi-centre study to determine reactogenicity and immunogenicity of heterologous prime/boost COVID-19 vaccine schedules in adolescents | | University of Oxford | 16/09/2021 | 20210916 | ISRCTN | https://www.isrctn.com/ISRCTN12348322 | Recruiting | No | | | Both | 20/09/2021 | 360 | Interventional | Single-blinded randomized controlled phase II multi-centre (Prevention) | Phase II | United Kingdom;England | Emma | Plested |
Oxford Vaccine Centre
Centre for Clinical Vaccinology & Tropical Medicine
University of Oxford
Churchill Hospital
| info@ovg.ox.ac.uk | +44 (0)1865 611400 | | Inclusion criteria: <br> 1. Parent/legal guardian/participant is willing and able to give written informed consent for participation in the trial<br> 2. Aged 12 to 16 years inclusive at enrolment<br> 3. In good health as determined by a trial clinician. Participants may have well controlled or mild-moderate comorbidity, as long as this would not render them eligible for 2 doses of COVID-19 vaccine (see exclusion criteria below) as part of the national roll out<br> 4. Able and willing (in the Investigator’s opinion) to comply with all study requirements<br> 5. Registered with a GP, and willing to allow the investigators to discuss the participant’s medical history with their General Practitioner and access all medical records when relevant to study procedures<br> | Exclusion criteria: <br> 1. Previous receipt of more than one dose of a COVID-19 vaccine, or a COVID-19 vaccine other than BNT162b2<br> 2. Belonging to a cohort advised to receive 2 doses of a COVID-19 vaccine (participants at increased risk of COVID-19, or household contacts of immunocompromised, based on JCVI and ‘Green Book guidelines).<br> 3. First degree relative of a study site staff member<br> 4. Any confirmed or suspected immunosuppressive or immunodeficient state; asplenia; recurrent severe infections and use of immunosuppressant medication within the past 6 months, except topical steroids or short-term oral steroids (course lasting =14 days)<br> 5. History of anaphylaxis, allergic disease or reactions likely to be exacerbated by any component of study vaccines (e.g. hypersensitivity to the active substance or any of the SmPC/IB-listed ingredients of any study vaccine). This includes latex and polyethylene glycol/macrogol (PEG)<br> 6. Pregnancy, lactation or unwillingness to practice effective contraception from enrolment to 3 months post booster vaccination, for post-menarcheal females only<br> 7. Malignancy requiring receipt of immunosuppressive chemotherapy or radiotherapy for treatment of solid organ cancer/haematological malignancy within the 6 months prior to consent.<br> 8. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following IM injections or venepuncture<br> 9. Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e. warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran and edoxaban)<br> 10. Any serious chronic illness requiring hospital specialist supervision<br> 11. Congenital cardiovascular conditions<br> 12. Severe and/or uncontrolled respiratory disease, gastrointestinal disease, liver disease, renal disease, rheumatological disease, and neurological illness (mild/moderate well controlled comorbidities are allowed)<br> 13. History of active or previous auto-immune neurological disorders (e.g. multiple sclerosis, Guillain-Barre syndrome, transverse myelitis)<br> 14. Significant renal or hepatic impairment<br> 15. Scheduled elective surgery requiring overnight admission and/or general anaesthetic during the trial<br> 16. Insufficient level of English language to undertake all study requirements in opinion of the Investigators<br> 17. Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccines<br> 18. Participants who have participated in another research trial involving an investigational product in the past 12 weeks<br> 19. Note that a prior history of confirmed or suspected COVID-19 is NOT an exclusion criterion for this study, provided the participant otherwise satisfies the health screening criteria for the study<br> | Prevention of COVID-19 infection in adolescents between 12-16 years of age. <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> Current intervention as of 27/10/2021:<br> All participants will receive first immunisation with a standard dose of Pfizer-BioNTech (BNT162b2) vaccine, dose of 30 µg (0.3ml) and 15 µg (0.15ml). This may either be given in the study, or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine, given at least eight weeks after the first, will be one of the following four possibilities:<br><br> 1. A full standard dose of Pfizer-BioNTec vaccine<br> 2. A third of a standard dose of Pfizer-BioNTec vaccine<br> 3. A half standard dose of Moderna COVID-19 vaccine, dose of 50 µg (0.25ml)<br> 4. A standard dose of Novavax NVXCoV2373, dose of 5 µg SARS-CoV-2 rS + 50 µg Matrix-M1 adjuvant (0.5ml)<br><br> All vaccines will be administered intramuscularly according to specific SOPs.<br><br> Computer generated randomisation list will be prepared by the study statistician. Participants will be randomised 1:1:1:1 to the four groups using block randomisation (random block sizes of 4 and 8).<br><br> Follow up is for 12 months.<br><br><br> Previous intervention:<br> All participants will receive first immunisation with a standard dose of Pfizer-BioNTech (BNT162b2) vaccine, dose of 30 µg (0.3ml) and 15 µg (0.15ml). This may either be given in the study, or it may have been given in the community before enrolment in the study. A second dose of COVID-19 vaccine, given at least eight weeks after the first, will be one of the following four possibilities:<br><br> 1. A full standard dose of Pfizer-BioNTec vaccine<br> 2. A half standard dose of Pfizer-BioNTec vaccine<br> 3. A half standard dose of Mo | Solicited systemic reactions measured by self-report 7 days after booster immunisation | | 31/12/2022 | | Yes | False | | |
| → | ISRCTN31161020 | 1 November 2021→8 November 2021 | Reducing stress in the workplace using a digital intervention designed to improve employee wellbeing and help them stay engaged and productive in work | REducing STress in the workplace | | University of Warwick | 08/06/2021 | 20210608 | ISRCTN | https://www.isrctn.com/ISRCTN31161020 | Recruiting | No | | | Both | 11/06/2021 | 420 | Interventional | Multicentre interventional waitlist randomized-controlled feasibility trial (Treatment) | Not Applicable | United Kingdom;England | Charlotte | Kershaw | University of Warwick | Charlotte.Kershaw@warwick.ac.uk | - | | Inclusion criteria: <br> 1. Able to give informed consent<br> 2. English-speaking<br> 3. In employment (including being on furlough)<br> 4. Insomnia Severity Index score <8<br> 5. General Anxiety Disorder-7 score >5 or Patient Health Questionnaire-9 score >5<br> 6. =18 years of age<br> | Exclusion criteria: <br> 1. Currently receiving treatment (psychological or pharmacological) from mental health services (e.g. GP, private clinic, Improving Access to Psychological Therapies (IAPT) services, specialist and community mental health services)<br> 2. Retiring in the next 10 months<br> 3. Currently taking part in other psychological intervention trials<br> | Prevention and treatment of anxiety and depression in employees from across the Midlands region in the United Kingdom. <br>Mental and Behavioural Disorders | <br> Participants are randomly allocated through blocked randomised with stratification into the REST intervention or a waitlist control. We stratify across different employer sites in the Midlands to ensure weighting approximate to staff size and representative of the larger population.<br><br> Those in the REST intervention will be offered an 8-week self-guided, digital intervention. The intervention will consist of an hour weekly commitment. Content for the self-guided intervention will be digitised and presented via an online platform, with each component being tailored to maximise relevance of the treatment as a workplace intervention and generalisability of the treatment across industries.<br><br> The core components of the REST intervention will include:<br> 1. Psychoeducation on stress, depression and anxiety<br> 2. Emotion regulation skills training (non-judgmental awareness, acceptance and tolerance, effective self-support, analysis and modification)<br> 3. Problem solving skills training and goal setting<br> 4. Managing negative thoughts and cognitive restructuring<br> 5. Mental health in times of COVID-19 (e.g. work life balance, psychological detachment from work when working from home)<br> 6. Healthy lifestyle (e.g. physical activity, relaxation and mindfulness, eating habits and sleep)<br> 7. Self-compassion and resiliency<br> | <br> Current primary outcome measure as of 28/10/2021:<br> 1. Number of organisations contacted and participating in the trial measured using recruitment and participation data collected during the recruitment process and throughout the trial<br> 2. Number of employees registering interest, screening for, and participating in the trial measured using recruitment and participation data collected during the recruitment process and throughout the trial<br> 3. Number of topics covered by each participant on platform measured using usage data collected by the platform over the 8 week intervention period<br> 4. Average duration to cover each topic by each participant measured using usage data collected by the platform over the 8 week intervention period<br><br> Previous primary outcome measure:<br> 1. Anxiety is measured using the General Anxiety Disorder-7 at baseline, post-intervention (8-weeks) and follow-up (12-weeks)<br> 2. Depression is measured using the Patient Health Questionnaire-9 at baseline, post-intervention (8-weeks) and follow-up (12-weeks)<br> | | 01/04/2022 | | Yes | False | | |
| → | ISRCTN11203922 | 1 November 2021→8 November 2021 | Neuropsychological evaluation and rehabilitation in multiple sclerosis – feasibility study | Neuropsychological Evaluation and Rehabilitation in Multiple Sclerosis (NEuRoMS): multicentre feasibility randomised controlled trial and fidelity evaluation (Phase 2: Work Package 3 feasibility study) | | Nottinghamshire Healthcare NHS Foundation Trust | 09/02/2021 | 20210209 | ISRCTN | https://www.isrctn.com/ISRCTN11203922 | Recruiting | No | | | Both | 15/11/2021 | 2545 | Interventional | Randomized; Both Interventional and Observational; Design type: Treatment, Screening, Process of Care, Psychological & Behavioural, Complex Intervention, Management of Care, Validation of investigation /therapeutic procedures (Treatment) | Not Applicable | United Kingdom;England;Wales | | | | | | | Inclusion criteria: <br> All individuals:<br> Able and willing to give consent and able to communicate in English. Participant information sheets can be provided in Welsh upon request but the standardised materials and tests to be used require communication in English since these have not yet been developed for other languages.<br><br> Part 1 – testing the cognitive screening pathway:<br> People with MS:<br> 1. Diagnosis of MS<br> 2. Aged 18 years or above<br><br> Part 2 – acceptability, feasibility RCT and fidelity evaluation:<br> People with MS:<br> 1. Diagnosis of MS<br> 2. Received cognitive screening and mild cognitive problems identified (Part 1)<br> 3. Aged 18 years or above<br><br> Part 3 – interviews:<br> 1. People with MS:<br> 1.1. People with MS participated in Part 2<br> 2. Intervention providers:<br> 2.1. Assistant Psychologist/Research Nurses/Assistant Occupational Therapist delivering the NEuRoMS intervention to people with MS in Part 2<br> 3. Clinicians:<br> 3.1. Health professionals (e.g., neurologists, MS nurse specialists, psychologists, occupational therapists) delivering the NEuRoMS screening and management pathway to people with MS<br> | Exclusion criteria: <br> Part 2 participants only:<br> 1. Currently receiving neuropsychological intervention for cognitive problems<br> 2. Received NEuRoMS intervention during WP2ii<br><br> All participants:<br> 1. Does not have the mental capacity to consent to take part in the study<br> | Multiple sclerosis <br>Nervous System Diseases <br>Multiple sclerosis | <br> Patients with mild cognitive problems will be randomly allocated to receive either an intervention plus usual care or usual care only (control group).<br><br> The NEuRoMS cognitive management intervention is multi-faceted, involving various components (i.e., information provision, goal setting) and a range of strategies and techniques (e.g., psychoeducation, compensatory strategies, boosting cognitive reserve). The intervention is person-centred, tailored to the needs and lifestyle of each participant, and aims to help people with MS cope with and manage cognitive problems by establishing strategies that can be maintained once the intervention sessions are finished. The intervention will be delivered by a trained therapist (Assistant Psychologist, Research Nurse, or Assistant Occupational Therapist), under the supervision of a clinical psychologist or Occupational Therapist). Face-to-face (dependent on Government and NHS COVID-19 advice), videoconferencing and telephone delivery options will be available. The duration of the intervention will be up to 4 hours spread across up to 6 sessions. The researchers anticipate these sessions to occur over a 2-month period, based on patient availability.<br> | <br> Part 2 – acceptability, feasibility RCT and fidelity evaluation:<br> 1. Feasibility and suitability of trial procedures based on response rates, trial uptake and the number of dropouts; measured throughout data collection period<br> 2. Feasibility of recruitment: measured throughout the data collection period, as assessed by:<br> 2.1. Appropriateness of eligibility criteria – the number of those referred to the trial who meet the eligibility criteria and the number of those eligible who expressed interest in the trial<br> 2.2. Success of recruitment strategy – recruitment rate recorded as the number of eligible patients who consent to participate in the trial within the trial recruitment period, and the number of patients who decline to participate (including reasons for non-participation)<br> 2.3. Retention rates assessed as the number of participants who consent to participate that remain in the trial by 6-month follow-up<br> 3. Appropriateness of self-report clinical and health economics measures at three data collection time points (baseline, 3-month and 6-month follow-up), as assessed by: completion rates, rate of return of online/postal questionnaires, level of missing data and completeness of measures, number of participants requiring reminders and extra telephone support to complete the measures and content of contacts between service providers/researchers and patient participants<br> 4. Patient preference for different versions/formats of the outcome data collection tools, measured at three time points (baseline, 3-month and 6-month follow-up), as assessed by: the number completed via paper/online/telephone, the number and types of reminders participants required to complete the tools, data completeness (the number of missing data), the number of participants who complete 3-month and 6-month follow-up measures.<br> 5. Fidelity of the intervention, measured throughout data collection period, as assessed by:<br> 5.1. The accuracy of intervention delivery recording and quality of intervention delivery, through intervention record forms, audio-/video-recordings of intervention sessions, and case notes of interventions<br> 5.2. Contextual and process issues related to intervention delivery, assessed by a review of clinical notes, intervention record forms, audio-/video-recordings of intervention sessions, and through monthly supervision and mentoring sessions with the NEuRoMS therapists and the interviews (Part 3)<br> 6. Documentation of usual care and contamination, measured throughout the data collection period, as assessed by:<br> 6.1 Record of cognitive management/support provided (if any) by the clinical team as routine care and as part of the screening management pathway; assessed by a review of clinical notes and resource use questionnaires, and through monthly teleconferences/videoconferences with clinicians, monthly supervision and mentoring sessions with the NEuRoMS therapists and the Part 3 interviews.<br> 6.2. Records of potential sources of contamination to determine the extent to which participants in the control group received the NEuRoMS intervention, assessed by a review of clinical notes and resource use questionnaire, and through monthly supervision and mentoring sessions with the NEuRoMS therapists and the Part 3 interviews.<br> | | 31/10/2022 | | Yes | False | | |
| → | ISRCTN21447815 | 1 November 2021→8 November 2021 | Studying aerosol emission of the COVID-19 virus in healthcare settings | AERosolisation And Transmission Of SARS-CoV-2 in Healthcare Settings (AERATOR) | | North Bristol NHS Trust | 16/10/2020 | 20201016 | ISRCTN | https://www.isrctn.com/ISRCTN21447815 | Not Recruiting | No | | | Both | 19/09/2020 | 600 | Observational | Aerosol and environmental sampling study (Other) | Not Applicable | United Kingdom;England | Fergus | Hamilton |
Infection Science
Pathology Services
Southmead Hospital
| fergus.hamilton@nbt.nhs.uk | +44 (0)07743165499 | | Inclusion criteria: <br> Patients:<br> 1. Undergoing procedure that is potentially aerosol-generating<br> 2. Aged over 18<br> 3. Have capacity<br><br> Healthy volunteers:<br> 1. Have capacity to consent to the study<br> 2. Aged over 18<br> | Exclusion criteria: <br> Patients:<br> 1. Unable to read/understand PIS (either printed version or via translator)<br> 2. Unable to consent<br><br> Healthy volunteers:<br> 1. Flu-like symptoms (fevers, temperature, new cough, sore throat, loss of smell, breathing difficulties) in the 48 hours prior to study enrolment<br> 2. Clinical contraindication to the procedure being performed<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> The AERATOR study will be carried out using specialist equipment in operating theatres and wards to measure real-life aerosol generation in five clinical settings: dental, orthopaedic, respiratory, critical care and ophthalmology. By using specialist equipment, only available at the University of Bristol, the research team will also investigate how long coronavirus survives while airborne and how environmental conditions impact on the infectivity of the virus.<br><br> The research will also advise guidelines on the appropriate level of PPE for staff, as well as the length of time the aerosol is present for and how it spreads in a real-world clinical setting.<br><br> The total duration of observation for each participant is around 15 minutes to 1 hour. The trial will run for 1 year.<br> | <br> 1. Distribution of aerosol produced during routine or simulated procedures measured using Aerodynamic Particle Sensors during the procedure, and for up to 10 minutes after<br> 2. Distribution of aerosol produced during routine or simulated procedures measured using Optical Particle Sensors during the procedure, and for up to 10 minutes after<br> | | 19/09/2021 | | No | False | | |
| → | ISRCTN10980107 | 1 November 2021→8 November 2021 | Long-term follow up of adults hospitalised with COVID-19 | Post-hospitalisation COVID-19 study: a national consortium to understand and improve long-term health outcomes (PHOSP-COVID) | | University of Leicester | 22/07/2020 | 20200722 | ISRCTN | https://www.isrctn.com/ISRCTN10980107 | Recruiting | No | | | Both | 25/07/2020 | 10000 | Observational | Prospective observational longitudinal study (Other) | Not Applicable | United Kingdom;England;Northern Ireland;Scotland;Wales | Ananga | Sundari Devi Dasi |
NIHR Biomedical Research Centre- Respiratory
Department of Respiratory Sciences
College of Life Sciences
Glenfield Hospital
Groby Road
| phosp@leicester.ac.uk | - | | Inclusion criteria: <br> 1. Participant admitted to an acute admissions unit or ward at a UK hospital and discharged with suspected COVID-19<br> 2. Age 18 years and over<br> 3. Participant is willing and able to give informed consent for participation in the study<br> 4. Aged 18 years or above<br> | Exclusion criteria: <br> 1. Confirmed diagnosis of a pathogen unrelated to the objectives of this study and no indication or likelihood of co-infection with a relevant pathogen<br> 2. Attendance at an A&E or emergency department only<br> 3. Refusal by participant, parent or appropriate representative<br> 4. Other life-limiting illness with life expectancy <6 months such as disseminated malignancy<br> | Adult survivors of a hospital admission with COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> PHOSP-COVID is an observational longitudinal follow-up study of adults post-hospitalisation with COVID-19. The researchers propose to analyse routine clinical data with linkage to retrospective and prospective health and social care records (Tier 1), enhanced clinical data and research-specific biosampling (Tier 2) and re-call of participants by genotype and phenotype for more detailed studies (Tier 3).<br><br> All participants will be followed up for at least 12 months after discharge from hospital. The researchers will ask participants for their agreement to continue to extract data from their electronic records, and to be contacted about future research, for at least 25 years after recruitment to the study.<br> | <br> 1. Incidence of long-term sequelae of COVID-19 measured using multiple methods including:<br> 1. Symptoms and quality of life measured using one or more of the following questionnaires: EQ-5D, Sarcopenia screen (SARC-F), General Practice Physical Activity Questionnaire (GPPAQ), Dyspnoea-12, Fatigue (FACIT), Brief Pain Inventory (BPI), Nottingham extended activity of daily living (NEADL), MRC dyspnoea score, Montreal Cognitive Assessment (MoCA), Clinical Frailty Scale, Fried Frailty assessment<br> 2. Mental health: symptoms of anxiety assessed using Generalised Anxiety Disorder Assessment (GAD-7), depression assessed using Patient Health Questionnaire (PHQ-9), post-traumatic stress disorder (PTSD) checklist (PCL-5)<br> 3. Physical function measured using one or more the following tests: Short Physical Performance Battery (SPPB), Incremental Shuttle Walk Test (ISWT), muscle strength tests (handgrip and quadriceps strength), physical activity monitoring, cardiometabolic risk assessment and body composition measurements<br> 4. Biological samples taken e.g blood, urine, sputum, saliva, breath<br> 5. Any imaging as part of clinical care<br> Measured at 6 weeks, 3 months, 6 months and 12 months post-hospital discharge (and at regular timepoints thereafter for up to 25 years)<br> Please note that not all participants will be asked to complete or perform all of the above questionnaires and tests. Data from routine clinical investigations and tests will be recorded.<br> 2. Healthcare utilisation measured using questionnaires and linkage to health and social care records at 6 weeks, 3 months, 6 months and 12 months post-hospital discharge (and at regular timepoints thereafter for up to 25 years)<br> 3. Mortality measured using ONS data at 6 weeks, 3 months, 6 months and 12 months post-hospital discharge (and at regular timepoints thereafter for up to 25 years)<br> | | 31/12/2046 | | Yes | False | | |
| → | ISRCTN10974028 | 1 November 2021→8 November 2021 | Language intervention in the early years - comparing the effectiveness of language intervention approaches for pre-school children with language difficulties | Language Intervention in the Early Years: comparing the efficacy of Building Early Sentences Therapy and the Derbyshire Language Scheme in improving language and functional communication outcomes in pre-school children with language disorder | | Newcastle University | 08/01/2020 | 20200108 | ISRCTN | https://www.isrctn.com/ISRCTN10974028 | Recruiting | No | | | Both | 01/02/2020 | 104 | Interventional | Cluster randomised control trial (Treatment) | Not Applicable | United Kingdom | Cristina | McKean |
School of Education, Communication and Language Sciences
Newcastle University
King George VI Building
Queen Victoria Road
| cristina.mckean@newcastle.ac.uk | +44 (0)191 208 6528 | | Inclusion criteria: <br> 1. Aged 3.5 - 4.5 years<br> 2. Monolingual speaker of English/English as main language<br> 3. Scoring at or below the 16th centile on a standardised play-based language assessment<br> 4. With the ability to participate in a small group learning context<br> | Exclusion criteria: <br> 1. Sensorineural hearing impairment<br> 2. Severe visual impairment<br> 3. Diagnosed learning disability<br> | Language disorder <br>Mental and Behavioural Disorders <br>Developmental disorder of speech and language, unspecified | <br> Current interventions as of 24/02/2021:<br><br> The Heather van der Lely Foundation has granted funding to Newcastle and Manchester Universities to conduct a cluster randomised control trial across 24 schools in the North East of England. Schools will be recruited from Newcastle, South Tyneside and Gateshead. If more than the target number are recruited, 24 will be randomly chosen to be part of the trial. This group of 24 will be split into two geographical areas of 12 schools (areas A and B) to facilitate timely<br> delivery of the interventions by the research team and to complete intervention delivery and data collection within allocated resources.<br><br> As a result of changes made due to COVID-19 the number of schools involved in the project for each wave of the study has been reduced. Some schools have left the project meaning there are now 21 schools participating. Some of these 21 schools will work with the project during the first wave (March-Sept 2021), up to 16 schools will work with the project for the second wave (Sept 2021-April 2022). Some will work with the project for both waves. This was determined based on<br> which schools were able to commit to the project. If a school participates in both waves they will remain in the same arm. The schools have been split into two geographical areas.<br><br> Schools were randomized to one of three arms; (Building Early Sentences Therapy (BEST), Derbyshire Language Scheme (DLS) and Continued Classroom Support (CCS)). The randomization was undertaken by the minimization method, attempting to balance across the arms on geographic region (A/B) and the proportion of pupils eligible for Pupil Premium (High/Low). The minimization method attempts to balan | <br> Current primary outcome measure as of 24/02/2021:<br><br> The outcomes of interest are children’s oral language development and their communicative participation. Children are assessed on all outcome measures at three time-points: baseline, outcome and follow-up. Baseline testing will happen when children are identified at the start of each wave, Outcome testing within 4 weeks of end of intervention, and Follow up testing approximately 8-12 weeks after intervention. Intervention group comparisons will be made on measures at outcome and at follow-up.<br><br> Intention to treat and per protocol analyses will be conducted on all outcome measures which vary in their hypothesised distance from the intervention taught material.<br><br> 1. Near: targeted sentence structures assessed through experimenter designed BEST and DLS assessments including picture description eliciting targeted sentence structures and a ‘toy test’ to assess comprehension of these sentences.<br> 2. Intermediate: New Reynell Developmental Language Scales.<br> 3. Far: FOCUS (Focus on the Outcomes of Communication Under Six); parent and teacher report measure of communicative participation.<br><br> Use of near, intermediate and far outcomes allow exploration of differences between interventions with respect to the degree to which learning transfers to broader language skills and communicative participation. Hence we do not make a distinction between primary and secondary outcomes but rather explore the effects on all 3 outcomes. It is possible that different approaches may have differing effects for each outcome.<br><br> For intention-to-treat analyses the average outcome score across the three treatment arms on the relevant outcome measure will be used for all missing data. Per-protocol analyses will be conducted on all children with complete outcome data. Qualitative data regarding barriers and enablers to intervention delivery (reflective field notes) will be triangulated with a comparison between intention-to-treat and per-protocol outcomes to inform successful implementation of effective interventions into practice.<br><br> Moderator analyses will be completed to identify whether differential effects across language interventions exist depending upon the children’s language profiles (severity, receptive-expressive language difficulties and/or scores on morpho-phonological processing).<br><br> A moderator analysis will be completed using Vineland 3 scores to determine whether differential effects exist depending on non-verbal ability.<br><br> Finally, a latent variable outcome analysis will be conducted using the three direct assessments of oral language using multilevel structural equation modelling (SEM) to account for the cluster randomisation. The outcome will be a latent language variable created from the New Reynell Developmental Language Scales, the BEST and DLS language assessments. The rationale for this approach is to evaluate to what degree the interventions may affect a unitary underlying language factor. The effects of the intervention will be measured by an appropriate effect size such as standardized differences in means comparing the two treatment arms.<br><br> _____<br><br> Previous primary outcome measure:<br><br> The outcomes of interest are children’s oral language development and their communicative participation. Children are assessed on all outcome measures at three time-points: baseline, outcome and follow-up. Baseline testing will happen when children are identified at the start of each wave, Outcome testing within 4 weeks of end of intervention, and Follow up testing approximately 8-12 weeks after intervention. Intervention group comparisons will be made on measures at outcome and at follow-up.<br><br> Intention to treat and per protocol analyses will be conducted on all outcome measures which vary in their hypothesised distance from the intervention taught material.<br><br> 1. Near: targeted sentence structures assessed through experimenter designed BEST and DLS assessments including picture description eliciting targeted sentence structures and a ‘toy test’ to assess comprehension of these sentences.<br> 2. Intermediate: New Reynell Developmental Language Scales.<br> 3. Far: FOCUS (Focus on the Outcomes of Communication Under Six); parent and teacher report measure of communicative participation.<br><br> Use of near, intermediate and far outcomes allow exploration of differences between interventions with respect to the degree to which learning transfers to broader language skills and communicative participation. Hence we do not make a distinction between primary and secondary outcomes but rather explore the effects on all 3 outcomes. It is possible that different approaches may have differing effects for each outcome.<br><br> For intention-to-treat analyses the average outcome score across the three treatment arms on the relevant outcome measure will be used for all missing data. Per-protocol analyses will be conducted on all children with complete outcome data. Qualitative data regarding barriers and enablers to intervention delivery (reflective field notes) will be triangulated with a comparison between intention-to-treat and per-protocol outcomes to inform successful implementation of effective interventions into practice.<br><br> Moderator analyses will be completed to identify whether differential effects across language interventions exist depending upon the children’s language profiles (severity, receptive-expressive language difficulties and/or scores on morpho-phonological processing).<br><br> Finally, a latent variable outcome analysis will be conducted using the three direct assessments of oral language using multilevel structural equation modelling (SEM) to account for the cluster-randomisation. The outcome will be a latent language variable created from the New Reynell Developmental Language Scales, the BEST and DLS language assessments. The rationale for this approach is to evaluate to what degree the interventions may affect a unitary underlying language factor. The effects of the intervention will be measured by an appropriate effect size such as standardized differences in means comparing the three treatment arms.<br> | | 01/06/2022 | | Yes | False | | |
| +++ | EUCTR2020-001656-18-NO | 8 November 2021 | The aim of this trial is to see how we can increase the amount of oxygen in the blood of a patient who may suffer from Covid-19 and severe breathing difficulties. Such patient often need intubation and mechanical ventilation, and we will compare twi ways of preparing for such intubation. The first is todays normal treatment with the patient breathing 100% oxygen on a bag/mask with some resistance. The other is that oxygen treatment combined with inhaled nitric oxide. | Inhaled Nitric Oxide As A Bridge To Mechanical Ventilation In Patients With Suspected Covid-19 Respiratory Failure
- INOCOV-19 | | Oslo University Hospital | 24/04/2020 | 20200424 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001656-18 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 19/05/2020 | 54 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Norway | Air Ambulance Department | | Kirkeveien 166 | cbuskop@ous-hf.no | 4722 11 80 80 | Oslo University Hospital | Inclusion criteria: <br>All criteria must apply <br><br>Patients = 18 years of age at the time of inclusion <br><br>and <br><br>who are confirmed, suspected or probable cases of covid-19 based on WHO definitions <br><br>and <br><br>SpO2 <90% after 3 minutes 10 cm H2O PEEP + 100% O2 <br><br>and <br><br>who are treated by a physician who have specifically undergone formal training in pre-hospital INO administration and the present protocol. <br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 54<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 54<br> | Exclusion criteria: <br>Only one criterion needs to apply for exclusion:<br>1. Patients who after 3 mins of ventilation with 10 cm H2O PEEP + 100% O2 i.e. at time of allocation (t0), have a SpO2 <50%, or a reliable SpO2 is impossible to obtain <br>2. Patients in severe kidney failure or dialysis, <br>3. Known or suspected pregnancy based on information on the time of inclusion. <br>4. Hypersensitivity to the active substance (NO) or to the excipient (N2) <br>5. Cardiac arrest<br>6. Patient in prison or custody by police<br>7. Staff present in treatment situation known to be pregnant<br>8. Any reason why, in the opinion of the treating physician, it is probably in the best interest of the patient not to participate in the trial.<br><br><br>Female participants under the age of 50 years will be asked explicitly about possible pregnancy. If this cannot be obtained from the patient, next of kin will be asked if present. Information regarding exclusion criteria 2, 3 and 4 will be obtained from bystanders, often relatives or friends present at time of inclusion. If no clear information is available, the physicians shall include or exclude based on his/her best judgment at the time of inclusion.<br><br> | Severe respiratory failure in patients with confirmed, suspected or probable Covid- 19 disease;Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] | <br>Trade Name: INOmax 800 ppm mol/mol<br>Product Name: INOmax<br>Pharmaceutical Form: Medicinal gas, compressed<br><br> | Timepoint(s) of evaluation of this end point: five minutes after the allocation of treatment arm, with IMP being administered by bag/mask ventilation, with 100% oxygen at a flow of 10lite/minute and a Positive End Expiratory pressure of 10 centimeter water.;Primary end point(s): The primary outcome measure is the change in SpO2, and the null hypothesis is that there is no difference in the change in SpO2 following initiation of INO;Secondary Objective: *Evaluate the safety of the intervention as compared to the control as assed by: Circulatory function, Kidney function , Hemoglobin function, Platelet count <br>*Evaluate the clinical efficacy of INO compared to standard treatment on respiratory severity and length of specialized care <br>*Evaluate the effect of INO on cardiac stress ;Main Objective: The overall objective of the study is to evaluate the clinical efficacy and safety of INO compared to standard treatment prior to and during emergency RSI in hypoxic patients with suspected or confirmed COVID-19 | | | | Yes | False | | |
| +++ | EUCTR2021-003246-20-ES | 8 November 2021 | Phase 2b study, conducted in few medical centers, patients will be allocated randomly to receive active drug or placebo. The study will evaluate the efficacy and safety of the drug in patients with respiratory failure due to COVID-19. | A Phase 2b Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study, Evaluating Efficacy and Safety of Allocetra-OTS in Patients with Severe or Critical COVID-19 with Associated Acute Respiratory Distress Syndrome | | Enlivex Therapeutics R&D, Ltd. | 27/07/2021 | 20210727 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-003246-20 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 02/11/2021 | 152 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Greece;Spain;Israel;Germany | Regulatory unit | | 103 Haros Str | regulatory@accelsiors.com | +3612990091 | Accelsiors CRO and Consultancy Services Ltd. | Inclusion criteria: <br>1. Male or female >18 and <85 years of age.<br>2. Laboratory confirmation of SARS-CoV-2 infection by reverse transcription polymerase chain reaction from any diagnostic sampling source.<br>3. Patient hospitalized due to COVID-19 within 7 days prior to enrollment, meeting the criteria for severe or critical COVID-19 <br>4. Patient with mild to moderate ARDS:<br>5. Signed written informed consent by the patient.<br>6. Women and men who are of childbearing potential, willing to use acceptable contraceptive measures during 4 weeks from enrollment.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 62<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 90<br> | Exclusion criteria: <br>1. Patient on IMV/ECMO.<br>2. Woman who is pregnant or breastfeeding.<br>3. Patient with weight <50 kg or >120 kg or BMI >40 kg/m2.<br>4. Patient with stage 4 or 5 chronic kidney disease or estimated glomerular filtration rate <30 mL/min.<br>5. Patient with an active malignant tumor (diagnosed or on active treatment for the past 6 months).<br>6. Patient who is participating in other concurrent interventional clinical trials or have been treated with any experimental agents within 30 days prior to enrollment.<br>7. Patient who based on their medical history and receipt of therapies that would suggest infection, has suspected serious, active bacterial (including a suspected clinical diagnosis of current active tuberculosis [TB] or, if known, latent TB treated for less than 4 weeks with appropriate anti-TB therapy per institutional guidelines), fungal, or viral (including, but not limited to, active HBV, HCV, or HIV/AIDS) infection.<br>8. Patient with known immunocompromised state or immunosuppressive medications taken for indications other than SARS-CoV-2 as follows: <br>a. Prednisone or equivalent to a dose >10 mg/day, methotrexate >15 mg/week, within the last 60 days; cyclophosphamide, cyclosporine A (unless as ophthalmic formulation), leflunomide/teriflunomide (unless as monotherapy), tacrolimus (unless as a topical formulation), everolimus, temsirolimus, or azathioprine, in the last 60 days;<br>b. Methylprednisolone, dexamethasone, cortisone, or betamethasone for more than 7 days within the last 28 days or within 5 half-lives, whichever is longer;<br>c. Chemotherapy in the last 3 months; <br>d. Mycophenolate mofetil or sirolimus for solid organ transplant or bone marrow transplant;<br>e. Thalidomide within the last 72 hours;<br>f. Anti-tumor necrosis factor (TNF) agents, interleukin (IL)-1 receptor antagonists, CTLA-4 fusion proteins, anti-CD20, anti-CD52, anti-IL-2, anti-IL-6R, anti-IL-12/23, anti-B-cell activation factor (BAFF) or integrin inhibitor agents within the last 8 weeks.<br>9. Patient with known New York Heart Association (NYHA) class III and IV heart failure or unstable angina, ventricular arrhythmias, ischemic heart disease, or myocardial infarction within 6 months prior to diagnosis of COVID-19.<br>10. Patient with known active upper gastrointestinal (GI) tract ulceration or hepatic dysfunction including but not limited to biopsy-proven cirrhosis; end-stage cirrhosis (Child Pugh Class C); portal hypertension; episodes of past upper GI bleeding attributed to portal hypertension; or prior episodes of hepatic failure, encephalopathy, or coma.<br>11. Patient with known idiopathic pulmonary fibrosis.<br>12. Patient with chronic respiratory disease requiring home oxygen therapy on a regular basis for more than 6 hours per day.<br>13. Patient with known chronic obstructive pulmonary disease GOLD 4 (forced expiratory volume in one second <30% predicted).<br>14. Patient with any medical, psychiatric or substance abuse condition, concurrent medical therapies, or abnormal laboratory values that in the opinion of the site Investigator may be of greater safety risk, influence response to study product, or interfere with the study assessments.<br>15. Patient with Glasgow Coma Scale <13 with verbal score <5.<br>16. Patient with hemoglobin <8 g/dL.<br>17. Patient with history of chronic liver disease, evidence of acute cholangitis or cholecystitis. Patients with at least one of the following:<br>• Alanine transaminase (ALT) or aspartate transaminase<br>(AST) >10×ULN (upper limit of normal)<br>• Bilirubin >5× | COVID-19 <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: Allocetra-OTS cells in Ringer's Lactate Solution<br>Pharmaceutical Form: Solution for infusion<br>INN or Proposed INN: allogeneic peripheral blood mononuclear cells induced to apoptotic state<br>Other descriptive name: Allogeneic peripheral blood mononuclear cells induced to apoptotic state<br>Concentration unit: Other<br>Concentration type: equal<br>Concentration number: 10000000000-<br>Pharmaceutical form of the placebo: Solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br> | Timepoint(s) of evaluation of this end point: 28 days;Primary end point(s): A primary composite endpoint will be assessed, as compared to placebo, separately for the two study subpopulations (severely ill and critically ill patients):<br>- Time (days) to improvement, defined as the first day, during the period of 28 days post study treatment administration, when a patient reached the score of 6, 7 or 8 on the 8-point ordinal scale.<br>If no improvement is reached by Day 28, the patient will be assigned a maximal score of 29.<br>- Support by invasive mechanical ventilation (IMV)/ECMO. If required during the period of 28 days post study treatment administration, a patient will be assigned the maximal score of 29.<br>- Mortality by Day 28 post study treatment administration. Deceased patients will be assigned the maximal score of 29.;Secondary Objective: To assess additional efficacy parameters and the safety of Allocetra-OTS in the treatment of COVID-19 patients;Main Objective: To assess the effect of Allocetra-OTS on ventilation-free survival and recovery in the treatment of COVID-19 patients | | | | Yes | False | | |
| → | EUCTR2020-005759-18-DK | 10 August 2021→8 November 2021 | A study to evaluate the Efficacy, Safety, and Antiviral Activity of RO7496998 (AT-527) in Patients with Mild or Moderate COVID-19 | A MULTICENTER, PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, OUTPATIENT STUDY TO EVALUATE THE EFFICACY, SAFETY, AND ANTIVIRAL ACTIVITY OF RO7496998 AT-527 IN PATIENTS WITH MILD OR MODERATE COVID-19 | | F. Hoffmann La Roche Ltd. | 16/03/2021 | 20210316 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005759-18 | Authorised→Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 18/05/2021 | 1386 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Japan;Germany;Peru;Denmark;Romania;Belgium;Brazil;Poland;Argentina;Mexico;Hungary;France;Italy;Switzerland;Colombia;Russian Federation;Turkey;Ukraine;Spain;United States;Serbia;Portugal→Portugal;Serbia;United States;Spain;Ukraine;Turkey;Russian Federation;Colombia;Switzerland;Italy;France;Hungary;Mexico;Argentina;Poland;Brazil;Belgium;Romania;Denmark;Peru;Germany;Japan | Trial Information Support Line-TISL | | Grenzacherstrasse 124 | global.rochegenentechtrials@roche.com | | F. Hoffmann La Roche Ltd. | Inclusion criteria: <br>Age >=18 years (regardless of weight) at the time of signing informed consent or age >=12 to <18 years (weight >=40 kilogram) at the time of signing informed consent (and assent)<br>Ability to comply with all aspects of the study protocol, including providing samples for virology, in the opinion of the investigator<br>At least three of the following symptoms of at least moderate (score >=2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea<br>Positive severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) diagnostic test (reverse-transcriptase polymerase chain reaction [RT-PCR] or validated rapid antigen test) <=72 hours prior to randomization<br>Symptoms consistent with mild or moderate COVID-19, as determined by the Investigator, with onset <=5 days before randomization<br>For women of childbearing potential and girls at or beyond menarche (age >=12 to <18 years): agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 30 days after the final dose of RO7496998 (AT-527)<br><br><br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: 150<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 1236<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>Clinical signs indicative of COVID-19 illness requiring hospitalization<br>Admitted to a hospital prior to randomization or is hospitalized (inpatient) at randomization due to COVID-19<br>In the opinion of the investigator, is likely to experience imminent deterioration and require hospitalization<br>Treatment with an investigational drug within 5 half-lives or 3 months (whichever is longer) of randomization<br>Treatment with a COVID-19 therapeutic agent against SARS-CoV-2 including, but not limited to, other direct or indirect acting antivirals against SARS CoV 2 (such as remdesivir or favipiravir), systemic or inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal antibodies against SARS CoV-2 or Interleukin 6 (IL-2) intravenous immunoglobulin or other emergency use authorization (EUA)-approved treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit<br>Concomitant use of P-glycoprotein (P-gp) inhibitors or inducers<br>Known allergy or hypersensitivity to components of study drug<br>Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of RO7496998 (AT-527)<br>Abnormal laboratory test results at screening<br>Requirement of any prohibited medications during the study<br>Other known active viral or bacterial infection at the time of screening, such as influenza. This exclusion does not apply to patients with stable chronic viral infections, such as chronic HCV or HIV providing other eligibility criteria are met<br>Any clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations during the study<br>COVID 19 vaccination within <=40 days prior to enrollment (second dose if applicable)<br> | Mild to Moderate coronavirus disease 2019 (COVID-19) <br>MedDRA version: 23.1
Level: LLT
Classification code 10084401
Term: COVID-19 respiratory infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: RO7496998 hemisulfate (AT-527)<br>Product Code: RO7496998<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Not available yet<br>CAS Number: 2241337-84-6<br>Current Sponsor code: RO7496998<br>Other descriptive name: AT-527<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 275-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: 1. Day 1 to day 29;Secondary Objective: -To evaluate the efficacy of RO7496998 (AT-527) compared with placebo (defined as the time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours) based on:<br>Time to alleviation or improvement of COVID-19 symptoms <br>Time to alleviation of symptoms<br>Time to one-category improvement of baseline presenting COVID-19 symptoms <br>Time to alleviation of individual symptoms <br>Proportion of patients requiring hospitalization for COVID-19<br>Proportion of patients with >=1 COVID-19 related medically attended visit through to study end<br>Duration of fever <br>Frequency of COVID-19 related complications,<br>Proportion of patients with any post-treatment infection <br>Proportion of patients with all-cause mortality<br>-To evaluate the antiviral activity of RO7496998 (AT-527) compared with placebo<br>-To evaluate the safety of RO7496998 (AT-527) compared with placebo<br>-To characterize the pharmacokinetic (PK) profile of AT-511 and major metabolites in plasma<br><br>;Main Objective: To evaluate the efficacy of RO7496998 (AT-527) compared with placebo based on the time to alleviation or improvement of COVID-19 symptoms;Primary end point(s): 1.Time to alleviation or improvement of COVID-19 symptoms (Items 1-12 of the COVID-19 symptom diary) maintained for a duration of 21.5 hours<br>defined as follows:<br>For new symptoms: time from randomization to the alleviation of COVID 19 symptoms (i.e., a score of 0 [none] or 1 [mild] on the COVID 19 Symptom Diary) <br>For preexisting symptoms: time from randomization to when a patient’s symptoms have been maintained or improved (Note: Improved requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale)<br>→Timepoint(s) of evaluation of this end point: 1. Day 1 to day 29;Primary end point(s): 1.Time to alleviation or improvement of COVID-19 symptoms (Items 1-12 of the COVID-19 symptom diary) maintained for a duration of 21.5 hours<br>defined as follows:<br>For new symptoms: time from randomization to the alleviation of COVID 19 symptoms (i.e., a score of 0 [none] or 1 [mild] on the COVID 19 Symptom Diary) <br>For preexisting symptoms: time from randomization to when a patient’s symptoms have been maintained or improved (Note: Improved requires at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale)<br>;Secondary Objective: -To evaluate the efficacy of RO7496998 (AT-527) compared with placebo (defined as the time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours) based on:<br>Time to alleviation or improvement of COVID-19 symptoms <br>Time to alleviation of symptoms<br>Time to one-category improvement of baseline presenting COVID-19 symptoms <br>Time to alleviation of individual symptoms <br>Proportion of patients requiring hospitalization for COVID-19<br>Proportion of patients with >=1 COVID-19 related medically attended visit through to study end<br>Duration of fever <br>Frequency of COVID-19 related complications,<br>Proportion of patients with any post-treatment infection <br>Proportion of patients with all-cause mortality<br>-To evaluate the antiviral activity of RO7496998 (AT-527) compared with placebo<br>-To evaluate the safety of RO7496998 (AT-527) compared with placebo<br>-To characterize the pharmacokinetic (PK) profile of AT-511 and major metabolites in plasma<br><br>;Main Objective: To evaluate the efficacy of RO7496998 (AT-527) compared with placebo based on the time to alleviation or improvement of COVID-19 symptoms | | | | Yes | True | parent | |
| +++ | EUCTR2021-001338-21-ES | 8 November 2021 | A Study of Baricitinib in Children With COVID-19 (COV-BARRIER-PEDS) | A Multicenter, Open-Label, Pharmacokinetic and Safety Study of Baricitinib in Pediatric Patients from 1 Year to Less Than 18 Years Old Hospitalized with
COVID-19 - COV-BARRIER-PEDS | | Lilly S.A. | 23/08/2021 | 20210823 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-001338-21 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 04/11/2021 | 24 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 1<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| United States;Mexico;Belgium;Brazil;Spain;Netherlands;Italy | Clinical Trial Registry Office | | Island House, Eastgate Road, Eastgate Business Park, Little Island | ensayosclinicos@lilly.com | 34918362958 | Eli Lilly Cork Ltd | Inclusion criteria: <br>- Male or female patients from 1 to <18 years of age at the time of enrollment<br>- Hospitalized with coronavirus (SARS-CoV-2) infection, confirmed by NAAT or immunodiagnostic tests, with a positive result in a sample collected no more than 14 days prior to treatment assignment<br>- Require supplmental oxygen and have chest imaging findings to confirm respiratory disease due to COVID-19 within 72 hours of study entry and enrollment<br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: 24<br>F.1.2 Adults (18-64 years) no<br>F.1.2.1 Number of subjects for this age range 0<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range 0<br> | Exclusion criteria: <br>- Are receiving biologic treatments (such as TNF inhibitors, interleukin inhibitors, T-cell or B-cell targeted therapies, interferons, or JAK inhibitors) for any indication at study entry; or are receiving other immunosuppressants such that, in the opinion of the investigator, participating in the study would put the participant at an unacceptable risk of immunosuppression. Note: A washout period is required prior to screening.<br>- Are receiving strong inhibitors of OAT3 (such as probenecid) that cannot be discontinued at study entry.<br>- Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required)<br>- Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product<br>- Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study. Note: use of nonlive (inactivated) vaccinations is allowed for all participants<br>- Require invasive mechanical ventilation, including extracorporeal membrane oxygenation (ECMO) at study entry<br>- Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product<br>- Have any history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or pulmonary embolism [PE]) or are considered at high risk of VTE (DVT/PE) by the investigator<br>- Anticipated discharge from the hospital, or transfer to another hospital (or another unit), which is not a study site within 72 hours after study entry<br>- Have neutropenia (absolute neutrophil count < 1000 cells/microliters)<br>- Have lymphopenia (absolute lymphocyte count < 200 cells/microliters)<br>- Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times AAULN<br>- Estimated glomerular filtration rate (eGFR) <40 milliliter/minute/1.73 meters squared<br> | COVID-19 infection <br>MedDRA version: 23.0
Level: PT
Classification code 10051905
Term: Coronavirus infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: Olumiant<br>Product Code: LY3009104<br>Pharmaceutical Form: Oral suspension<br>INN or Proposed INN: BARICITINIB<br>Other descriptive name: BARICITINIB<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 2-<br><br> | Timepoint(s) of evaluation of this end point: Day 1 and day 4;Primary end point(s): Pharmacokinetic parameters, including AUC and Cmax of baricitinib, in pediatric patients with COVID-19;Secondary Objective: - To describe the safety of baricitinib in pediatric patients with COVID-19<br>- To describe the effect of baricitinib on COVID-19 progression in pediatric patients<br>- To describe clinical outcomes in pediatric patients with COVID-19 treated with baricitinib;Main Objective: To characterize the pharmacokinetics (PK) of baricitinib in pediatric patients with COVID-19 | | | | Yes | True | parent | |
| → | EUCTR2021-000417-16-DE | 26 October 2021→8 November 2021 | A trial to test the safety and efficacy of a new drug (human immune cells against COVID-19, administered intravenously) for patients with COVID-19 in need of treatment or at risk for severe COVID-19 | A Phase I / randomized Phase II trial to analyse safety and efficacy of human SARS-CoV 2 specific T lymphocyte transfer in patients with COVID-19 in need of treatment or at risk of severe COVID-19 - ACT-COVID19 | | University of Cologne | 01/04/2021 | 20210401 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000417-16 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 20/10/2021 | 51 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>Other trial design description: Phase I: monocentric open label, Phase II: multi-centre, randomized, IMP+SoC versus SoC<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: In Phase II: IMP+SoC versus SoC<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): yes
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Germany | Project Manager | | Gleueler Str. 269 | ulrike.zettelmeyer@uk-koeln.de | 0049221478 88125 | CTC Cologne | Inclusion criteria: <br>For phase I and II<br>• Ability to understand the purpose and risks of the study and provide signed and dated informed consent (participants = 18 years of age)<br>• Willing to follow contraception guidelines<br>• Tested positive for SARS-CoV-2 by PCR <72 hours prior to inclusion<br>WHO score 4 with at least one additional risk factor for disease progression<br>Acceptable risk factors are:<br>o Radiographically proven lung infiltrates<br>o Immunosuppression either by malignant disease or its treatment, or other underlying diseases leading to immunodeficiency or underlying diseases that require treatment resulting in immunosuppression<br>o Immunosuppressive drugs, including steroids at a prednisolone equivalent of <1 mg/kg BW. 6mg dexamethasone per os or intravenous 1x/d (SOC) are allowed, but are not considered as inclusion criterion in the sense of immunosuppressive treatment<br>o Receipt of an autologous transplant within the last 5 years<br>o Receipt of an allogeneic transplant within the last 5 years or ongoing immunosuppression OR<br>o WHO score Score 5<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 34<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 17<br>→Inclusion criteria: <br>For phase I and II<br>1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent (participants = 18 years of age)<br>2. Willing to follow contraception guidelines<br>3. Tested positive for SARS-CoV-2 by PCR <72 hours prior to inclusion <br>4. A maximum of 14 days between onset of symptoms and<br>enrollment<br>5. WHO score 4 with at least one additional risk factor for disease progression<br>Acceptable risk factors are:<br>a. Radiographically proven lung infiltrates<br>b. Immunosuppression either by malignant disease or its treatment, or other underlying diseases leading to immunodeficiency or underlying diseases that require treatment resulting in immunosuppression<br>c. Immunosuppressive drugs, including steroids at a prednisolone equivalent of <1 mg/kg BW. 6mg dexamethasone per os or intravenous 1x/d (SOC) are allowed, but are not considered as inclusion criterion in the sense of immunosuppressive treatment<br>d. Receipt of an autologous transplant within the last 5 years<br>e. Receipt of an allogeneic transplant within the last 5 years or ongoing immunosuppression OR<br>6. WHO score Score 5<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 34<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 17<br> | Exclusion criteria: <br>For phase I and II<br>• Participation in any other clinical trial of an experimental agent treatment for COVID-19<br>• Active or history of GvHD<br>• COVID-19 WHO ordinal scale =6<br>• Anticipated life-expectancy <72 hours<br>• Expected duration of hospital stay <72 hours<br>• Leukocytes <1000/µl or platelets <50.000/µl unless resulting from underlying disease or its treatment<br>• CT pneumonia score =13, if CT has been performed as SoC<br>• Any other Steroids = 1mg/kg Prednisolon-equivalent/kg BW, besides 6mg Dexamethasone i.v. or p.o. 1x/d as SoC for COVID-19<br>• Pregnant or breast feeding<br>• Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator's judgment, precludes the subject’s safe participation in and completion of the study<br>• Therapeutic donor lymphocyte infusion (DLI) from 4 weeks prior to IMP infusion until 8 weeks post IMP infusion<br>• Known hypersensitivity to iron dextran<br><br>→Exclusion criteria: <br>For phase I and II<br>1. Participation in any other clinical trial of an experimental agent treatment <br>2. Active or history of GvHD<br>3. History of CAR-T-Cell Therapy<br>4. COVID-19 WHO ordinal scale =6<br>5. Anticipated life-expectancy <72 hours<br>6. Expected duration of hospital stay <72 hours<br>7. Sepsis-induced leukopenia or thrombocytopenia (leukocytes <1000/µl or platelets <50.000/µl). If the cytopenias result from underlying hematologic disease or its treatment, this will not be<br>regarded as exclusion criterion.<br>8. CT pneumonia score =13, if CT has been performed as SoC<br>9. Any other Steroids = 1mg/kg Prednisolon-equivalent/kg BW, besides 6mg Dexamethasone i.v. or p.o. 1x/d as SoC for COVID-19<br>10. Therapeutic donor lymphocyte infusion (DLI) less than 100 days prior to IMP infusion<br>11. Known hypersensitivity to iron dextran<br>12. Known pre-existing human anti-mouse antibodies (HAMAs)<br>13. Contraindication against mandatory protocol-inherent comedication(s): antihistamine and/or<br>acetaminophen<br>14. Pregnant or breast feeding<br>15. Any serious medical condition or abnormality of clinical laboratory tests that, in the Investigator's judgment, precludes the subject’s safe participation in and completion of the study<br><br><br> | Patients who are tested positive for SARS-CoV-2 by PCR from upper or lower respiratory sites and are at increased risk for developing critical disease presenting with moderate disease
-WHO ordinal scale 4 with at least one additional risk factor for disease progression
or
-WHO ordinal scale 5 <br>MedDRA version: 23.0
Level: LLT
Classification code 10084272
Term: SARS-CoV-2 infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: human SARS-CoV-2 specific T lymphocytes<br>Product Code: SUB222337<br>Pharmaceutical Form: Infusion<br>INN or Proposed INN: human SARS-CoV-2 specific T lymphocytes<br>Current Sponsor code: human SARS-CoV-2-specific T lymphocytes<br>Other descriptive name: Allogeneic SARS-CoV-2-specific CD4+ and CD8+ T lymphocytes<br>Concentration unit: Other<br>Concentration type: up to<br>Concentration number: 5000-<br><br> | Timepoint(s) of evaluation of this end point: Please see protocol section 4.8.;Primary end point(s): Phase I<br>• Dose-limiting toxicities until day 28 after infusion of human SARS-CoV-2- specific T lymphocytes<br>Phase II<br>• AUC of the course of disease measured by the WHO ordinal scale for COVID-19;Secondary Objective: Phase I part:<br>- To assess the feasibility of production of human SARS-CoV-2-specific T lymphocytes from convalescent donors with a HLA match of >1/6 loci<br>- Assessment of human SARS-CoV-2-specific T lymphocytes persistence after infusion<br><br>Phase II part:<br>- Evaluation of safety and tolerability of a single administration of human SARS-CoV-2-specific <br>T lymphocytes<br>- Overall survival (OS) of patients treated with human SARS-CoV-2-specific T lymphocytes (until day 100)<br>- Effect of human SARS-CoV-2 –specific T lymphocytes infusion on viral shedding in nasooropharyngeal swabs<br>- Characterization of efficacy with respect to the course of disease<br>;Main Objective: Phase I part:<br>- To determine the recommended phase II dose (RP2D) of human SARS-CoV-2-specific T lymphocytes by evaluation of safety and tolerability<br><br>Phase II part:<br>- To gain first data on efficacy of human SARS-CoV-2-specific T lymphocytes therapy<br>→Timepoint(s) of evaluation of this end point: Please see protocol section 4.8.;Primary end point(s): Phase I<br>• Dose-limiting toxicities until day 28 after infusion of viable human SARS-CoV-2- specific T lymphocytes<br>Phase II<br>• AUC of the course of disease measured by the WHO ordinal scale for COVID-19;Secondary Objective: Phase I part:<br>• To gain first data on biological activity of viable human SARS-CoV2-specific T lymphocyte therapy <br>• To assess the feasibility of production of viable human SARS-CoV-2-specific T lymphocytes from convalescent donors with a HLA match of = 2/6 loci and < 10/10<br>Phase II part:<br>• Evaluation of safety and tolerability of a single administration of viable human SARS-CoV-2-specific <br>T lymphocytes<br>• Overall survival (OS) of patients treated with viable human SARS-CoV-2-specific T lymphocytes (until day 100)<br>• Effect of viable human SARS-CoV-2 –specific T lymphocytes infusion on viral shedding in nasooropharyngeal swabs<br>• Characterization of efficacy with respect to the course of disease<br>;Main Objective: Phase I part:<br>• To determine the recommended phase II dose (RP2D) of viable human SARS-CoV-2-specific T lymphocytes by evaluation of safety and tolerability<br><br>Phase II part:<br>• To gain first data on efficacy of human SARS-CoV-2-specific T lymphocytes therapy<br> | | | | Yes | False | | |
| → | EUCTR2021-000541-41-DE | 8 October 2021→8 November 2021 | Joint European Research on active and emerging pandemics | European DisCoVeRy for Solidarity: An Adaptive Pandemic and Emerging Infection Platform Trial - EU-SolidAct | | Oslo University Hospital | 29/04/2021 | 20210429 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000541-41 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 09/06/2021 | 2000 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Norway;Germany;Poland;Belgium;Hungary;Czech Republic;France;Italy;Luxembourg;Austria;Turkey;Ireland;Spain;Greece;Slovakia;Czechia;Portugal→Portugal;Czechia;Slovakia;Greece;Spain;Ireland;Turkey;Austria;Luxembourg;Italy;France;Czech Republic;Hungary;Belgium;Poland;Germany;Norway | Surgery, Inflam Diseases,Transplant | | Sognsvannsveien 20 | marius.troseid@medisin.uio.no | +4792440240 | Oslo University Hospital | Inclusion criteria: <br>Master Protocol Number: 1.1 dated 07 April 2021:<br>Participants are eligible to be included in the study only if all the following general inclusion (GI) criteria apply:<br>GI1. = 18 years of age<br>GI2. Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR not more than 9 days old <br>GI3. Admitted to hospital<br>GI4. Informed consent by the participant or legally authorized representative.<br>GI5A: Moderate disease state defined as hospitalised patients without oxygen therapy or oxygen by mask or nasal prongs needed, or<br>GI5B: Severe/critical disease state defined as fulfilliing at least one of the following criteria:<br>1. SpO2<90% on room air, or<br>2. SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or<br>3. Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or<br>4. Need of mechanical ventilation/ECMO <br>*persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).<br>NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = Extracorporeal membrane oxygenation. <br>Additional inclusion criteria are given in the intervention-specific sub-protocols.<br><br>Baricitinib specific protocol v. 1.1 dated 07 April 2021: <br>All participants must be eligible according to the master protocol inclusion criteria (SolidAct Part B). <br>Only the general inclusion criteria (GI) for severe/critical COVID-19 are applicable:<br>GI1. =18 years of age<br>GI2. Laboratory-confirmed SARS-CoV-2 infection (new infection or reinfection) as determined by PCR in any specimen not more than 9 days old <br>GI3. Admitted to hospital<br>GI4. Informed consent by the participant or legally authorized representative.<br>GI5B: Severe/critical disease state defined as fulfilling at least one of the following criteria:<br>1. SpO2<90% on room air, or<br>2. SpO2 90-94% with a downwards trend and/or signs of respiratory distress*, or<br>3. Need of oxygen by NIV (CPAP, BIPAP), high flow or non-rebreather mask, or<br>4. Need of mechanical ventilation/ECMO <br>*persistently increased respiratory rate, use of accessory muscles, inability to complete full sentences. Clinical judgement must be applied to determine whether a low oxygen saturation is indicative of disease progression or severity or is habitual for a given patient (i.e., with underlying chronic lung disease).<br>NIV=non-invasive ventilation. CPAP= Continuous Positive Airway Pressure, BPAP= Bi-level Positive Airway Pressure, ECMO = extracorporeal membrane oxygenation. <br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 1000<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 1000<br> | Exclusion criteria: <br>Master Protocol Number 1.1 dated 07 April 2021:<br>Participants are excluded from the study if any of the following general exclusion criteria apply:<br>GE1. Anticipated transfer to another non-trial hospital within 72 hours<br>Additional exclusion criteria, included prohibited medication, confounding trials and details on contraception and pregnancy are given in the intervention-specific sub-protocols.<br><br>Baricitinib specific protocol v. 1.1 dated 07 April 2021:<br>GE1. Anticipated transfer to another non-trial hospital within 72 hours.<br><br>In addition, participants are excluded from being eligible for the intervention cohort if any of the additional specific exclusion (SE) criteria below apply: <br>• SE-01. Receiving cytotoxic or biologic treatments (such as tumour necrosis factor [TNF] inhibitors, anti-interleukin-1 [IL-1, e.g. anakinra], anti-IL-6 [e.g. tocilizumab or sarilumab], T-cell or B-cell targeted therapies (e.g. rituximab), interferon, or Janus kinase (JAK) inhibitors (including baricitinib) for any indication at study entry. <br>o Note: A washout period is required prior to screening<br>• SE-02. Have received high dose corticosteroids at doses >20 mg prednisone (or prednisone equivalent) per day administered for =14 consecutive days in the month prior to study entry. <br>• SE-03. Have received dexamethasone 6 mg once daily for more than 4 days prior to screening as part of SoC for severe/critical COVID-19 <br>• SE-04. Had COVID-related symptoms > 14 days or hospitalized > 7 days. <br>o Note: If hospitalized early in the disease and then progressing after >7 days of hospitalization, the patient could still be included if COVID-related symptoms had a duration < 14 days.<br>• SE-05. Strong inhibitors of organic anion transporter 3 [OAT3], (e.g. probenecid) that cannot be discontinued at study entry.<br>• SE-06. Have received neutralizing antibodies for COVID-19, except if receiving such treatment as part of EU SolidAct part A after disease progression.<br>• SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)). <br>o Note: Use of non-live (inactivated) vaccinations, including COVID-19 vaccinations, is allowed for all participants.<br>• SE-08. Are using or will use extracorporeal blood purification (EBP) device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device, for example, CytoSorb®.<br>• SE-09. Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).<br>• SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.<br>o Note: Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrolment, who, in the judgment of the investigator, are at increased risk for serious infections or other safety concerns should be excluded. However, well treated HIV infection with normal CD4+ T cell count and undetectable HIV-RNA is not an exclusion criterion per se.<br>• SE-11. Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.<br>o Note: although this risk is established from long term use of baricitinib→Exclusion criteria: <br>MASTER PROTOCOL V1.1<br>GE1. Anticipated transfer to another non-trial hospital within 72 hours<br>BARICITINIB SPECIFIC PROTOCOL v1.1 <br>Additionally:<br>• SE-01. Receiving cytotoxic or biologic treatments (such as TNF inhibitors, anti-IL-1 [e.g. anakinra], anti-IL-6 [e.g. tocilizumab or sarilumab], T-cell or B-cell targeted therapies (e.g. rituximab), interferon, or Janus kinase inhibitors (including baricitinib) for any indication at study entry. <br>o Note: A washout period is required prior to screening<br>• SE-02. Have received high dose corticosteroids at doses >20 mg prednisone (or prednisone equivalent) per day administered for =14 consecutive days in the month prior to study entry. <br>• SE-03. Have received dexamethasone 6 mg once daily for more than 4 days prior to screening as part of SoC for severe/critical COVID-19 <br>• SE-04. Had COVID-related symptoms > 14 days or hospitalized > 7 days. <br>o Note: If hospitalized early in the disease and then progressing after >7 days of hospitalization, the patient could still be included if COVID-related symptoms had a duration < 14 days.<br>• SE-05. Strong inhibitors of organic anion transporter 3 (e.g. probenecid) that cannot be discontinued at study entry.<br>• SE-06. Have received neutralizing antibodies for COVID-19, except if receiving such treatment as part of EU SolidAct part A after disease progression.<br>• SE-07. Have received any live vaccine within 4 weeks before screening, or intend to receive a live vaccine during the study (until day 90 (+/- 14 days)). <br>o Note: Use of non-live (inactivated) vaccinations, including COVID-19 vaccinations, is allowed for all participants.<br>• SE-08. Are using or will use extracorporeal blood purification device to remove proinflammatory cytokines from the blood such as a cytokine absorption or filtering device.<br>• SE-09. Have diagnosis of current active tuberculosis or, if known, latent TB treated for less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by history only, no screening tests required).<br>• SE-10. Suspected serious, active bacterial, fungal, viral, or other infection (besides COVID-19) that in the opinion of the investigator could constitute a risk when taking investigational product.<br>o Note: Immunocompromised patients, patients with a chronic medical condition, or those taking a medication that cannot be discontinued at enrolment, who, in the judgment of the investigator, are at increased risk for serious infections or other safety concerns should be excluded. However, well treated HIV infection with normal CD4+ T cell count and undetectable HIV-RNA is not an exclusion criterion per se.<br>• SE-11. Current diagnosis of active malignancy that, in the opinion of the investigator, could constitute a risk when taking investigational product.<br>o Note: although this risk is established from long term use of baricitinib, and probably does not pose the same risk in short term use for COVID-19, particular attention should be paid, as reflected in the list of adverse events of special interest<br>• SE-12. Have a history of venous thromboembolism (deep vein thrombosis and/or pulmonary embolism) within 12 weeks prior to randomization or have a history of recurrent (>1) VTE (DVT/PE).<br>• SE-13. Neutropenia (absolute neutrophil count <1000 cells/microliters).<br>• SE-14. Lymphopenia (absolute lymphocyte count <200 cells/microliters).<br>• SE-15. Alanine aminotransferase or aspartate aminotransferase >5 times ULN.<br>• SE-16. Subjects with eGFR <15 millilitre/minut | SARS-CoV infection <br>MedDRA version: 21.1
Level: LLT
Classification code 10037373
Term: Pulmonary disorder
System Organ Class: 100000004855
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Olumiant<br>Product Name: Olumiant<br>Pharmaceutical Form: Film-coated tablet<br>INN or Proposed INN: BARICITINIB<br>Other descriptive name: baricitinib<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 2-<br>Pharmaceutical form of the placebo: Film-coated tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: Master Protocol Number 1.1 dated 07 April 2021:<br>Part A: Within 14 days.<br>Part B: Within 60 days.<br><br>Baricitinib specific protocol v. 1.1 dated 07 April 2021: <br>Within 60 days.;Primary end point(s): Master Protocol Number 1.1 dated 07 April 2021:<br>Part A, moderate disease: Occurrence of disease progression, defined as a progression of disease state from moderate (WHO score 4-5) to severe/critical (WHO score 6-9) or death (WHO score 10) within 14 days. <br><br>Part B, severe disease: Occurrence of death within 60 days.<br><br>Baricitinib specific protocol v. 1.1 dated 07 April 2021:<br>Occurrence of death within 60 days;Secondary Objective: Master Protocol Number: 1.1 dated 07 Apr 2021:<br>Secondary objectives are: <br>1. to determine the effect of therapeutic interventions on other clinical endpoints<br>2. to determine the effect of therapeutic interventions on viral clearance<br>3. to determine the effect of therapeutic interventions on biochemical parameters<br>4. to assess the safety impact of therapeutic interventions on major serious adverse events <br>5. to determine the effect of therapeutic interventions on patient reported outcomes.<br>Baricitinib specific protocol v. 1.1, 07 Apr 2021:<br>Secondary objectives are <br>-to compare the efficacy of baricitinib vs. placebo on disease progression, time to sustained recovery and time to first hospital discharge <br>-to compare baricitinib vs. placebo on major SAE <br>-to compare baricitinib vs. placebo on patient reported outcomes <br>-to compare the efficacy of baricitinib vs. placebo on viral clearance<br>-to compare the efficacy of baricitinib vs. placebo on markers of systemic inflammation;Main Objective: Master Protocol Number: 1.1 dated 07 April 2021<br>Phase 3 objectives<br>Part A, moderate disease. The primary objective is to determine the effect of therapeutic interventions on occurrence of disease progression in hospitalized patients with moderate COVID-19. <br>Part B, severe disease. The primary objective is to determine the effect of therapeutic interventions on occurrence of death in hospitalized patients with severe or critical COVID-19.<br><br>Baricitib-specific protocol v. 1.1, dated 07 April 2021: The primary objective is to determine the effect of baricitinib vs. placebo added to SoC on occurrence of death in hospitalized patients with severe or critical COVID-19.→Main Objective: Master Protocol Number: 1.1 dated 07 April 2021<br>Phase 3 objectives<br>Part A, moderate disease. The primary objective is to determine the effect of therapeutic interventions on occurrence of disease progression in hospitalized patients with moderate COVID-19. <br>Part B, severe disease. The primary objective is to determine the effect of therapeutic interventions on occurrence of death in hospitalized patients with severe or critical COVID-19.<br><br>Baricitib-specific protocol v. 1.1, dated 07 April 2021: The primary objective is to determine the effect of baricitinib vs. placebo added to SoC on occurrence of death in hospitalized patients with severe or critical COVID-19.;Secondary Objective: Master Protocol Number: 1.1 dated 07 Apr 2021:<br>Secondary objectives are: <br>1. to determine the effect of therapeutic interventions on other clinical endpoints<br>2. to determine the effect of therapeutic interventions on viral clearance<br>3. to determine the effect of therapeutic interventions on biochemical parameters<br>4. to assess the safety impact of therapeutic interventions on major serious adverse events <br>5. to determine the effect of therapeutic interventions on patient reported outcomes.<br><br>Baricitinib specific protocol v. 1.1, 07 Apr 2021:<br>Secondary objectives are <br>-to compare the efficacy of baricitinib vs. placebo on disease progression, time to sustained recovery and time to first hospital discharge <br>-to compare baricitinib vs. placebo on major SAE <br>-to compare baricitinib vs. placebo on patient reported outcomes <br>-to compare the efficacy of baricitinib vs. placebo on viral clearance<br>-to compare the efficacy of baricitinib vs. placebo on markers of systemic inflammation;Timepoint(s) of evaluation of this end point: Master Protocol Number 1.1 dated 07 April 2021:<br>Part A: Within 14 days.<br>Part B: Within 60 days.<br><br>Baricitinib specific protocol v. 1.1 dated 07 April 2021: <br>Within 60 days.;Primary end point(s): Master Protocol Number 1.1 dated 07 April 2021:<br>Part A, moderate disease: Occurrence of disease progression, defined as a progression of disease state from moderate (WHO score 4-5) to severe/critical (WHO score 6-9) or death (WHO score 10) within 14 days. <br><br>Part B, severe disease: Occurrence of death within 60 days.<br><br>Baricitinib specific protocol v. 1.1 dated 07 April 2021:<br>Occurrence of death within 60 days | | | | Yes | True | parent | |
| → | EUCTR2021-000566-14-CZ | 26 April 2021→8 November 2021 | Post-authorization Phase IV effectiveness and safety multicentric study of COVID-19 vaccines – CoVigi | Post-authorization Phase IV effectiveness and safety multicentric study of COVID-19 vaccines – CoVigi | | Masarykova univerzita | 17/02/2021 | 20210217 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000566-14 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 17/03/2021 | 500→565 | Interventional clinical trial of medicinal product | Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
→Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Czech Republic | Farmakologický ústav LF MU | | Kamenice 5 | demlova@med.muni.cz | | Masarykova univerzita | Inclusion criteria: <br>1) Age = 18 years<br>2) Willingness to participate in the study expressed by signing the informed consent form<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 250<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 250<br>→Inclusion criteria: <br>1) Age = 18 years<br>2) Willingness to participate in the study expressed by signing the informed consent form<br><br>A subject can be included in a cohort of newly enrolled subjects with an already fully applied vaccination scheme according to SmPC, if they additionally meet the following criteria:<br>1) Patient in the care of the Department of Internal Hematology and Oncology, University Hospital Brno<br>2) Planned booster dose (3rd dose for the originally two-dose schedule, or 2nd dose for the single-dose schedule)<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 282<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 283<br> | Exclusion criteria: <br>1) Pregnancy, breastfeeding<br>2) Inadequacy of patient classification based on the individual assessment of the study physician<br> | COVID-19 Vaccines, monitoring of adverse events and evaluation of the immune response <br>MedDRA version: 23.1
Level: LLT
Classification code 10084465
Term: COVID-19 vaccination
System Organ Class: 100000004865
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: COVID-19 VACCINE ASTRAZENECA<br>Pharmaceutical Form: Suspension for injection<br><br>Trade Name: COVID-19 VACCINE MODERNA<br>Pharmaceutical Form: Dispersion for injection<br><br>Trade Name: COMIRNATY<br>Pharmaceutical Form: Dispersion for injection<br><br>→<br>Trade Name: VAXZEVRIA<br>Pharmaceutical Form: Suspension for injection<br><br>Trade Name: SPIKEVAX<br>Pharmaceutical Form: Dispersion for injection<br><br>Trade Name: COMIRNATY<br>Pharmaceutical Form: Dispersion for injection<br><br>Trade Name: COVID-19 VACCINE JANSSEN<br>Pharmaceutical Form: Suspension for injection<br><br> | Timepoint(s) of evaluation of this end point: 1) visit 2, 3 and 4<br>2) baseline (visit 1), visit 2, 3, 4, 5 and 6<br>3) from first vaccination dose to end of trial;Primary end point(s): 1) monitoring for adverse events and effects<br>2) evaluation of the immune response of vaccinated subjects<br>3) incidence of COVID-19 disease in vaccinated subjects;Secondary Objective: Exploratory: In a subgroup of cancer patients (patients with solid tumors) undergoing active anticancer therapy:<br>• Monitoring and evaluation of objectives and parametrs mentioned as primary <br>• Evaluation of the circulating immune profile<br>;Main Objective: 1) Post-authorization monitoring of adverse events and effects (data collection based on a questionnaire survey and evaluation by study physician)<br>• Severity, expectations, intensity, relationship to vaccination<br>• Nature of adverse event, duration<br>2) Evaluation of the immune response of vaccinated subjects by determining the level of antibodies and cellular immunity over time<br>3) Incidence of COVID-19 disease in vaccinated subjects based on information on a positive test for SARS-CoV-2 (clinically symptomatic and asymptomatic disease)→Timepoint(s) of evaluation of this end point: 1) visit 2, 3 and 4<br>2) baseline (visit 1), visit 2, 3, 4, 5 and 6<br>3) from first vaccination dose to end of trial;Primary end point(s): 1) monitoring for adverse events and effects<br>2) evaluation of the immune response of vaccinated subjects<br>3) incidence of COVID-19 disease in vaccinated subjects;Secondary Objective: Exploratory: In a subgroup of cancer patients (patients with solid tumors) undergoing active anticancer therapy:<br>• Monitoring and evaluation of objectives and parametrs mentioned as primary <br>• Evaluation of the circulating immune profile<br>• Evaluation of objectives and parameters in connection with the type of cancer treatment administered<br>;Main Objective: 1) Post-authorization monitoring of adverse events and effects (data collection based on a questionnaire survey and evaluation by study physician)<br>• Severity, expectations, intensity, relationship to vaccination<br>• Nature of adverse event, duration<br>2) Evaluation of the immune response of vaccinated subjects by determining the level of antibodies and cellular immunity over time<br>3) Incidence of COVID-19 disease in vaccinated subjects based on information on a positive test for SARS-CoV-2 (clinically symptomatic and asymptomatic disease) | | | | Yes | False | | |
| → | EUCTR2021-002693-10-AT | 26 July 2021→8 November 2021 | A Phase II Study to Evaluate Safety and Efficacy to a Third Vaccination with an mRNA or Vector Vaccine in Patients under Immunosuppressive Therapy Who did not Respond to Standard mRNA SARS-CoV-2 (Covid-19) Vaccination→A Phase II Study to Evaluate Safety and Efficacy to a Third Vaccination with an mRNA or Vector Vaccine in Patients under Immunosuppressive Therapy no or reduced Responds to Standard mRNA SARS-CoV-2 (Covid-19) Vaccination | A Randomized, Single-Blind, Phase II Study to Evaluate Safety and Efficacy to a Third Vaccination with a mRNA or Vector Vaccine in Patients under Immunosuppressive Therapy and no Humoral Response after Standard mRNA SARS-CoV-2 (Covid-19) Vaccination - VAC3 SARS-CoV-2 seroconversion study →A Phase II Study to Evaluate Safety and Efficacy to a Third Vaccination in Immunocompromised Patients with Inadequate Humoral Response after Primary mRNA SARS-CoV-2 (Covid-19) Vaccination - VAC3 SARS-CoV-2 seroconversion study | | Medical University of Vienna, Department for Internal Medicine III, Division of Rheumatology | 19/05/2021 | 20210519 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-002693-10 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 15/07/2021 | 150→300 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: yes<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 3<br>→Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: yes<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: yes<br>Other trial design description: Part A) single blind randomized control trial; Part B) open label trial<br>If controlled, specify comparator, Other Medicinial Product: yes<br>Placebo: no<br>Other: no<br>Number of treatment arms in the trial: 3<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| Austria | Clinical Trials Office | | Spitalgasse 23 | daniela.sieghart@meduniwien.ac.at | 004314040043010 | Medical University of Vienna | Inclusion criteria: <br>Male and female subjects will be eligible for participation in this study if they:<br>1. Are =18 years on the day of screening<br>2. Have been treated with immunosuppressive therapy within the last 12 months.<br>3. Received two doses of mRNA SARS-CoV-2 (Biontech/Pfizer or Moderna) vaccine according to recommendations in the label and/or national guidelines. <br>4. Did not develop humoral immunity 4 weeks after second mRNA vaccination to SARS-CoV-2 (analyzed during the study “Characterization of immune responsiveness after mRNA SARS-CoV-2 Vaccination in patients with immunodeficiency or immunosuppressive therapy”, EK-Nr. 1073/2021, EudraCT Nr. 2021-000291-11, or routine evaluation of humoral response)<br>5. A maximum of 12 months after second vaccination<br>6. Have an understanding of the study, agree to its provisions, and give written informed consent before study entry<br>7. If female and capable of bearing children – have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 75<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 75<br>→Inclusion criteria: <br>a) Male and female patients will be eligible for participation in this study if they:<br>1. Are =18 years on the day of screening<br>2. Being immunocompromised (either primary or secondary immunodeficiency or been treated with immunosuppressive therapy within the last 12 months<br>Immunosuppressive therapies include glucocorticoids, cytostatics, antibodies, drugs acting on immunophilins and other treatments like interferons and TNF binding proteins and exclude patients under B cell depleting therapy (like Rituximab, Ocrelicumab, Ofatumumab, Epratuzumab or Obinutuzumab)<br>3. Received two doses of SARS-CoV-2 (Biontech/Pfizer, Moderna) vaccine according to recommendations in the label and/or national guidelines. <br>4. Did develop < 1500 U/ml of SARS-CoV-2 antibodies 4 weeks after second mRNA vaccination (analyzed during the study “Characterization of immune responsiveness after mRNA SARS-CoV-2 Vaccination in patients with immunodeficiency or immunosuppressive therapy”, EK-Nr. 1073/2021, EudraCT Nr. 2021-000291-11, or external routine evaluation of humoral response)<br>5. A maximum of 12 months after second vaccination<br>6. Have an understanding of the study, agree to its provisions, and give written informed consent before study entry<br>7. If female and capable of bearing children – have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study<br>b) Male and female healthy controls will be eligible for participation in this study if they:<br>1. Are =18 years on the day of screening<br>2. Received two doses of SARS-CoV-2 (Biontech/Pfizer, Moderna) vaccine according to recommendations in the label and/or national guidelines. <br>3. Did develop < 1500 U/ml of SARS-CoV-2 antibodies 4 weeks after second mRNA vaccination<br>4. A maximum of 12 months after second vaccination<br>5. Have an understanding of the study, agree to its provisions, and give written informed consent before study entry<br>6. If female and capable of bearing children – have a negative urine pregnancy test result at study entry and agree to employ adequate birth control measures for the duration of the study<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 150<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 150<br> | Exclusion criteria: <br>Subjects will be excluded from participation in this study if they:<br>1. Have shown humoral response to the SARS-CoV-2 vaccination<br>2. Had grade 3 adverse effects from the mRNA vaccination reported<br>3. Pregnancy and breast feeding<br>4. Signs of SARS-CoV-2 infection (including previous positive PCR testing)<br>5. Any other contraindication to any of the study compounds<br>→Exclusion criteria: <br>Subjects will be excluded from participation in this study if they:<br>1. Have shown humoral response (> 1500 U/ml) to the SARS-CoV-2 vaccination<br>2. Had grade 3 adverse effects from the mRNA vaccination reported<br>3. Pregnancy and breast feeding<br>4. Signs of SARS-CoV-2 infection (including previous positive PCR testing)<br>5. Any other contraindication to any of the vaccine compounds<br>6. For healthy controls: diagnosis of chronic inflammatory condition including primary or secondary immunodeficiency or ever receiving immunosuppressing therapy as stated above <br><br> | Vaccination against SARS-CoV-2 in patients with immunosuppressive therapy;Therapeutic area: Diseases [C] - Immune System Diseases [C20]→Vaccination against SARS-CoV-2 in patients with immunosuppressive therapy or immunodeficiencies;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | <br>Trade Name: Comirnaty concentrate for dispersion for injection<br>Product Name: Comirnaty<br>Product Code: BNT162B2<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: COVID-19 mRNA Vaccine<br>CAS Number: 2417899-77-3<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br>Trade Name: Covid-19 Vaccine Moderna dispersion for injection<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: COVID-19 mRNA Vaccine<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br>Trade Name: Vaxzevria<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recombinant])<br>CAS Number: 2440395-83-9<br>Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)<br>Concentration unit: U unit(s)<br>Concentration type: not less then<br>Concentration number: 250000000-<br><br> | Secondary Objective: Secondary Objectives <br>• Cellular immunogenicity of the third mRNA SARS-CoV-2 vaccination will be compared to patients receiving a vector vaccination as second boost in immunosuppressed patients. T cell proliferation will be assessed, and T-cell cytokine expression will be measured using flow-cytometry following in vitro stimulation of peripheral blood mononuclear cells (PBMCs) with SARS-CoV-2 specific antigens<br>• To assess safety of a second boost vaccination.<br>• To evaluate the influence of vaccination on underlying disease activity;Main Objective: The study aims to investigate the humoral and cellular immune responses after a second boost vaccination against SARS-CoV-2 in adult patients treated with immunosuppressive therapy who did not show response to the first two vaccinations with an mRNA vaccine.<br>Primary Objective (Hypothesis)<br>To assess the immunogenicity to a third vaccination mRNA-SARS-CoV-2 vaccine (Biontech/Pfizer or Moderna) compared to a vector SARS-CoV-2 (AstraZeneca) vaccination as a second boost in patients with immunosuppressive therapy by measuring quantitative antibody levels by enzyme-linked immunosorbent assay test (ELISA) and neutralization test (NT) or pseudo viral neutralization assay.<br>Null and alternative hypotheses:<br>H0: There is no statistical difference in the seroconversion rate between patients receiving a third mRNA vaccination and the patients receiving a second boost with a vector vaccine.;Timepoint(s) of evaluation of this end point: 4 weeks after SARS-CoV-2 vaccination;Primary end point(s): Difference in SARS-CoV-2 antibody seroconversion rate by week 4 after vaccination boost at baseline between 3rd mRNA SARS-CoV-2 (Biontech/Pfizer or Moderna) and vector SARS-CoV-2 vaccine (AstraZeneca). →Timepoint(s) of evaluation of this end point: 4 weeks after SARS-CoV-2 vaccination;Primary end point(s): A) Difference in SARS-CoV-2 antibody seroconversion rate by week 4 after vaccination boost at baseline between 3rd mRNA SARS-CoV-2 (Biontech/Pfizer or Moderna) and vector SARS-CoV-2 vaccine (AstraZeneca). <br>B) The efficacy of a 3rd mRNA boost vaccination in immunocompromised patients with inadequate humoral response (antibody titre <1500U/ml) to standard SARS-CoV-2 vaccination will be compared to low titre heathy controls by assessing the difference in antibody titre change before and after a second boost between the two groups.;Secondary Objective: • Cellular immunogenicity of the third mRNA SARS-CoV-2 vaccination will be compared to patients receiving a vector vaccination as second boost in immunocompromised patients without prior humoral response. Further, T cell responses will be compared in immunocompromised patients as well as healthy controls before and after a second mRNA boost vaccination. T cell proliferation will be assessed, and T-cell cytokine expression will be measured using flow-cytometry following in vitro stimulation of peripheral blood mononuclear cells (PBMCs) with SARS-CoV-2 specific antigens.<br>• Comparison of total antibody titre after the second boost as well as absolute and relative change in antibody titre before and after the second boost in immunosuppressed patients versus the healthy controls <br>• To assess safety of a second boost vaccination. <br>• To qualitatively evaluate the influence of a second boost vaccination on underlying disease treated with immunosuppressive therapy. ;Main Objective: The study aims to investigate A) the humoral and cellular immune responses after a second boost vaccination against SARS-CoV-2 in adult patients treated with immunosuppressive therapy who did not show response to the first two vaccinations with an mRNA vaccine.<br>To assess the immunogenicity to a third vaccination mRNA-SARS-CoV-2 vaccine (Biontech/Pfizer or Moderna) compared to a vector SARS-CoV-2 (AstraZeneca) vaccination as a second boost in patients with immunosuppressive therapy.<br>B) To compare the immunogenicity to a third vaccination with a mRNA-SARS-CoV-2 vaccine as a second boost in immunocompromised patients and healthy controls who developed insufficient titres of antibodies (< 1500 U/ml) after the standard vaccination by measuring quantitative antibody levels by spike-protein-based assay. The level of antibody increase will be compared between the two groups. | | | | Yes | False | | |
| → | EUCTR2021-002857-28-HU | 24 August 2021→8 November 2021 | A Phase 2/3 Efficacy and Safety Study of PF-07321332/Ritonavir in Nonhospitalized Low-Risk Adult Participants With COVID-19 | AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2/3, DOUBLE-BLIND, 2 ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332/RITONAVIR COMPARED WITH PLACEBO IN NONHOSPITALIZED SYMPTOMATIC ADULT PARTICIPANTS WITH COVID-19 WHO ARE AT LOW RISK OF PROGRESSING TO SEVERE ILLNESS | | Pfizer Inc. | 29/07/2021 | 20210729 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-002857-28 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 18/08/2021 | 800→1140 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>Other trial design description: 2-arm<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Japan;Bulgaria;Poland;Brazil;Argentina;Mexico;Hungary;United Kingdom;Turkey;Czechia;Korea, Republic of;China;Netherlands;South Africa;Peru;Malaysia;Puerto Rico;India;Colombia;Russian Federation;Ukraine;Spain;Thailand;Taiwan;United States→United States;Taiwan;Thailand;Spain;Ukraine;Russian Federation;Colombia;India;Puerto Rico;Malaysia;Peru;South Africa;Netherlands;China;Korea, Republic of;Czechia;Turkey;United Kingdom;Hungary;Mexico;Argentina;Brazil;Poland;Bulgaria;Japan | Clinical Trials.gov Call Centre | | 235 East 42nd Street | ClinicalTrials.gov_Inquiries@pfizer.com | +18007181021 | Pfizer Inc. | Inclusion criteria: <br>1. Participants =18 years of age (or the minimum country specific age of consent if >18) at the time of the Screening Visit.<br>•WOCBP may be enrolled.<br>•All fertile participants must agree to use a highly effective method of contraception. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.<br>2. Confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen collected within 5 days prior to randomization. <br>Note: RT-PCR is the preferred method; however, with evolving approaches to confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed. The test result must be available to confirm eligibility. Participants may be enrolled based on positive results of a rapid SARS-CoV-2 antigen test performed at screening.<br>3. Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified signs/symptoms attributable to COVID-19 present on the day of randomization (see Appendix 9 for criteria).<br>4. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.<br>5. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.<br><br>Please refer to section 5.1 of the protocol. <br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 720<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 80<br>→Inclusion criteria: <br>1. Participants =18 years of age (or the minimum country specific age of consent if >18) at the time of the Screening Visit.<br>•WOCBP may be enrolled.<br>•All fertile participants must agree to use a highly effective method of contraception. Refer to Appendix 4 for reproductive criteria for male (Section 10.4.1) and female (Section 10.4.2) participants.<br>2. Confirmed SARS-CoV-2 infection as determined by RT-PCR in any specimen collected within 5 days prior to randomization. <br>Note: RT-PCR is the preferred method; however, with evolving approaches to confirmation of SARS-CoV-2 infection, other molecular or antigen tests that detect viral RNA or protein are allowed. The test result must be available to confirm eligibility. Participants may be enrolled based on positive results of a rapid SARS-CoV-2 antigen test performed at screening.<br>3. Initial onset of signs/symptoms attributable to COVID-19 within 5 days prior to the day of randomization and at least 1 of the specified signs/symptoms attributable to COVID-19 present on the day of randomization (see Appendix 9 for criteria).<br>4. Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.<br>5. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.<br><br>Please refer to section 5.1 of the protocol. <br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 1026<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 114<br> | Exclusion criteria: <br>1. Has at least 1 characteristic or underlying medical condition (self-report is acceptable) associated with an increased risk of developing severe illness from COVID-19 including:<br>Note: Participants with these conditions who are fully vaccinated (as defined by local regulations and practices) against SARS CoV-2 are considered to be at lower risk of developing severe disease and are therefore considered eligible. <br>•= 60 years of age;<br>•BMI >25;<br>•Current smoker (cigarette smoking within the past 30 days) and history of at least 100 lifetime cigarettes;<br>•Chronic lung disease (if asthma, requires daily prescribed therapy);<br>•Known diagnosis of hypertension;<br>•CVD, defined as history of any of the following: myocardial infarction, stroke, TIA, HF, angina with prescribed nitroglycerin, CABG, PCI, carotid endarterectomy, and aortic bypass;<br>•Type 1 or Type 2 diabetes mellitus;<br>•CKD;<br>• Sickle cell disease;<br>• Neurodevelopmental disorders (eg, cerebral palsy, Down’s syndrome) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes and severe congenital anomalies);<br>•Active cancer other than localized skin cancer, including those requiring treatment (including palliative treatment), as long as the treatment is not among the prohibited medications that must be administered/continued during the trial period;<br>•Medical-related technological dependence (eg, CPAP [not related to COVID-19]). <br>2.Immunosuppressive disease (eg, bone marrow or organ transplantation or primary immune deficiencies) OR prolonged use of immune-weakening medications:<br>•Has received corticosteroids equivalent to prednisone =20 mg daily for at least 14 consecutive days within 30 days prior to study entry;<br>•Has received treatment with biologics (eg, infliximab, ustekinumab, etc.), immunomodulators (eg, methotrexate, 6MP, azathioprine, etc), or cancer chemotherapy within 90 days prior to study entry’;<br>•HIV infection with CD4+ cell count <200/mm3. <br>3. History of hospitalization for the medical treatment of COVID-19. <br>4. Current need for hospitalization or anticipated need for hospitalization within 48 hours after randomization in the clinical opinion of the site investigator (see Section 8.1.2).<br>5. Prior to current disease episode, any confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any specimen collection. <br>6. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic or active hepatitis B or C infection, primary biliary cirrhosis, Child-Pugh Class B or C or acute liver failure.<br>7. Receiving dialysis or have known renal impairment.<br>8. Known HIV infection with viral load > 400 copies/ml or taking prohibited medications for HIV treatment (Appendix 8). <br>9. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.<br>10. Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.<br>11. History of hypersensitivity or other contraindication to any of the components of the study intervention, as determined by the investigator.<br>12. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the→Exclusion criteria: <br>1. Has at least 1 characteristic or underlying medical condition (self-report is acceptable) associated with an increased risk of developing severe illness from COVID-19 including:<br>Note: Participants with these conditions who are fully vaccinated (as defined by local regulations and practices) against SARS CoV-2 are considered to be at lower risk of developing severe disease and are therefore considered eligible. <br>•= 60 years of age;<br>•BMI >25;<br>•Current smoker (cigarette smoking within the past 30 days) and history of at least 100 lifetime cigarettes;<br>•Chronic lung disease (if asthma, requires daily prescribed therapy);<br>•Known diagnosis of hypertension;<br>•CVD, defined as history of any of the following: myocardial infarction, stroke, TIA, HF, angina with prescribed nitroglycerin, CABG, PCI, carotid endarterectomy, and aortic bypass;<br>•Type 1 or Type 2 diabetes mellitus;<br>•CKD;<br>• Sickle cell disease;<br>• Neurodevelopmental disorders (eg, cerebral palsy, Down’s syndrome) or other conditions that confer medical complexity (eg, genetic or metabolic syndromes and severe congenital anomalies);<br>•Active cancer other than localized skin cancer, including those requiring treatment (including palliative treatment), as long as the treatment is not among the prohibited medications that must be administered/continued during the trial period;<br>•Medical-related technological dependence (eg, CPAP [not related to COVID-19]). <br>2.Immunosuppressive disease (eg, bone marrow or organ transplantation or primary immune deficiencies) OR prolonged use of immune-weakening medications:<br>•Has received corticosteroids equivalent to prednisone =20 mg daily for at least 14 consecutive days within 30 days prior to study entry;<br>•Has received treatment with biologics (eg, infliximab, ustekinumab, etc.), immunomodulators (eg, methotrexate, 6MP, azathioprine, etc), or cancer chemotherapy within 90 days prior to study entry’;<br>•HIV infection with CD4+ cell count <200/mm3. <br>3. History of hospitalization for the medical treatment of COVID-19. <br>4. Current need for hospitalization or anticipated need for hospitalization within 48 hours after randomization in the clinical opinion of the site investigator (see Section 8.1.2).<br>5. Prior to current disease episode, any confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any specimen collection. <br>6. Known medical history of active liver disease (other than nonalcoholic hepatic steatosis), including chronic or active hepatitis B or C infection, primary biliary cirrhosis, Child-Pugh Class B or C or acute liver failure.<br>7. Receiving dialysis or have known renal impairment.<br>8. Known HIV infection with viral load > 400 copies/mL or taking prohibited medications for HIV treatment (Appendix 8). <br>9. Suspected or confirmed concurrent active systemic infection other than COVID-19 that may interfere with the evaluation of response to the study intervention.<br>10. Any comorbidity requiring hospitalization and/or surgery within 7 days prior to study entry, or that is considered life threatening within 30 days prior to study entry, as determined by the investigator.<br>11. History of hypersensitivity or other contraindication to any of the components of the study intervention, as determined by the investigator.<br>12. Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the | Coronavirus Disease 2019 (COVID-19) <br>MedDRA version: 23.1
Level: PT
Classification code 10084460
Term: COVID-19 treatment
System Organ Class: 10042613 - Surgical and medical procedures
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: RITONAVIR<br>Product Name: Ritonavir<br>Pharmaceutical Form: Capsule<br>INN or Proposed INN: RITONAVIR<br>CAS Number: 155213-67-5<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 100-<br>Pharmaceutical form of the placebo: Capsule<br>Route of administration of the placebo: Oral use<br><br>Product Code: PF-07321332<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: PF-07321332<br>Other descriptive name: PF-07321332<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 150-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: - through day 28;Primary end point(s): Time (days) to sustained alleviation of all targeted COVID-19 signs/symptoms through Day 28.;Secondary Objective: - To describe the safety and tolerability of PF-07321332/ritonavir relative to placebo in the treatment of nonhospitalized symptomatic adult participants with COVID-19 who are at low risk of progression to severe disease.<br>- To compare PF-07321332/ritonavir to placebo for the duration and severity of signs and symptoms in nonhospitalized symptomatic adult participants with COVID-19 who are at low risk of progression to severe disease.<br>- To compare PF-07321332/ritonavir versus placebo for COVID-19 related medical visits in nonhospitalized adult participants with COVID-19 who are at low risk of progression to severe disease.<br>- To compare PF-07321332/ritonavir versus placebo for hospitalization and all-cause mortality in nonhospitalized adult participants with COVID-19 who are at low risk of progression to severe disease.<br>*details of remaining objectives in Protocol;Main Objective: To compare the efficacy of PF-07321332/ritonavir to placebo for the treatment of symptomatic COVID-19 in nonhospitalized adult participants with COVID-19 who are at low risk of progression to severe disease.→Timepoint(s) of evaluation of this end point: - through day 28;Primary end point(s): Time (days) to sustained alleviation of all targeted COVID-19 signs/symptoms through Day 28.;Secondary Objective: - To describe the safety and tolerability of PF-07321332/ritonavir relative to placebo in the treatment of nonhospitalized symptomatic adult participants with COVID-19 who are at low risk of progression to severe disease.<br>- To compare the efficacy of PF 07321332/ritonavir to placebo for the treatment of symptomatic COVID-19 in nonhospitalized adult participants with COVID-19 who are at low risk of progression to severe disease.<br>- To compare PF-07321332/ritonavir to placebo for the duration and severity of signs and symptoms in nonhospitalized symptomatic adult participants with COVID-19 who are at low risk of progression to severe disease.<br>- To compare PF-07321332/ritonavir versus placebo for COVID-19 related medical visits in nonhospitalized adult participants with COVID-19 who are at low risk of progression to severe disease.<br>- To compare PF-07321332/ritonavir versus placebo for hospitalization and all-cause mortality in ...<br>*details of remaining objectives in Protocol;Main Objective: To compare the efficacy of PF 07321332/ritonavir to placebo for the treatment of symptomatic COVID-19 in nonhospitalized adult participants with COVID-19 who are at low risk of progression to severe disease. | | | | Yes | True | parent →child | |
| → | EUCTR2021-002024-21-CZ | 10 August 2021→8 November 2021 | Randomized placebo controlled clinical trial evaluating the safety and efficacy of ivermectin in hospitalized patients with Covid-19 disease | Randomized placebo controlled clinical trial evaluating the safety and efficacy of ivermectin in hospitalized patients with Covid-19 disease | | Fakultní nemocnice u sv. Anny v Brne | 28/04/2021 | 20210428 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-002024-21 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 09/06/2021 | 136 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Czech Republic | Oddelení klinických studií | | Pekarska 53 | trials.icrc@fnusa.cz | 00420731692781 | Fakultní nemocnice u sv. Anny v Brne | Inclusion criteria: <br>1) Age = 18 years<br>2) Willingness to participate in the clinical trial expressed by signing the informed consent form<br>3) Patients with confirmed Covid-19 disease requiring hospitalization with at least one of the following symptoms:<br>a. febrile illness above 38.5 ° C;<br>b. shortness of breath at rest or with minimal exertion,<br>c. oxygen-free saturation below 93 % SpO2,<br>d. inability to self-service, general exhaustion and more<br>4) Laboratory PCR confirmed positivity SARS-CoV-2 (nasopharyngeal swab) or positive antigen test not older than 5 days.<br>5) Clinical trial subjects of childbearing potential must agree to the use of the following methods of contraception for the duration of clinical trial and 3 months after the end of clinical trial.<br>a. For women of childbearing potential using one of the following methods:<br>i. highly reliable contraceptive methods within 3 months after end of clinical trial: combined hormonal contraception (oral, vaginal, transdermal), progesterone-containing contraceptives with ovulation inhibition (oral, injection), intrauterine non-hormonal or hormonal body, bilateral tubal occlusion or partner vasectomy<br>OR<br>ii. sexual abstinence if it is consistent with the lifestyle of the subject.<br>b. For men, use one of the following methods: observance of sexual abstinence (if it is consistent with the lifestyle of the subject) or use of an adequate contraceptive method (ie condom) in the case of sexual intercourse within 3 months after the end of clinical trial. <br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 110<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 26<br> | Exclusion criteria: <br>1) Pregnancy, breastfeeding, positive chorionic gonadotropin (hCG)<br>2) Inadequacy of classification of the subject on the basis of individual assessment of the examining physician<br>3) Age <18 years<br>4) Outpatient treatment of patients with Covid-19 disease<br>5) Hepatic impairment - alanine aminotransferase (ALT) and / or aspartate aminotransferase (AST)> 3x ULN detected before IP administration<br>6) Known hypersensitivity to the components of the preparation<br>7) Eating and fluid intake disorders and conditions limiting the bioavailability of the drug<br>8) Participation in another clinical trial<br>9) BMI > 35<br>10) Inability to swallow drugs<br>11) Current use of potent CYP3A4 inhibitors: fluconazole, fluoxetine, indinavir, itraconazole, clarithromycin, nifedipine, ritomavir, verapamil, voriconazole<br>12) Use of ivermectin 1 month before inclusion in CT<br>13) Bone marrow transplantation, history of hematopoietic disorders<br>14) Neurological disorders such as epilepsy that are treated with GABA agonists, such as baclofen, or past suicidal ideation or attempts<br> | Covid-19 disease <br>MedDRA version: 23.0
Level: LLT
Classification code 10084270
Term: SARS-CoV-2 acute respiratory disease
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Pharmaceutical Form: Capsule, hard<br>INN or Proposed INN: ivermectin<br>Other descriptive name: IVERMECTIN<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 3-<br>Pharmaceutical form of the placebo: Capsule, hard<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: 1. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28<br>2. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28<br>3. Day 1, Day 2, Day 3, Day 4, Day 5, Day 7, Day 10, Day 28;Primary end point(s): 1. Severity, expectations, intensity AE and association with IP and placebo<br>2. Nature of AE, duration<br>3. Improvement by at least one grade at the 8-level Ordinal Scale S1 assessment level, assessed on day 10 after the first IP / placebo administration;Secondary Objective: - Evaluation of the condition of patients at the level of 8-level Ordinal Scale S1 on individual days of the clinical trial<br>- Time to first improvement by 1 category compared to Day 1 on the 8-degree Ordinal Scale S1<br>- Time to first deterioration by 1 category compared to Day 1 on the 8-degree Ordinal Scale S1<br>- Duration (days) of need for oxygen therapy <br>- Length (days) of the need for non-invasive ventilation or high flow oxygenation <br>- Duration (days) of need for intubation and mechanical ventilation or organ support by vasopressors, dialysis or extracorporeal membrane oxygenation (ECMO)<br>- Mortality <br>- Length (days) of need for hospitalization<br>- change of X-ray findings on the lungs during the 10th day - upon the invetigator's decision and the length of hospitalization (control X-ray on the 10th day or on the day of discharge - in case of a clinical reason)<br>- Evaluation of concomitant treatment in both arms<br>- Evaluation of the change in viral load as a function of time ;Main Objective: Evaluation of the clinical safety of ivermectin versus placebo as an add-on therapy to the standard treatment of COVID-19 disease in both treatment arms.<br> | | | | Yes | False | | |
| → | EUCTR2020-001335-28-NL | 28 June 2021→8 November 2021 | A phase II/III study of IFX-1 in patients with severe COVID-19 Pneumonia | A pragmatic adaptive randomized controlled Phase II/III multicenter study of IFX-1 in Patients with severe COVID-19 Pneumonia - "PANAMO" - Panamo | | InflaRx GmbH | 27/03/2020 | 20200327 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-001335-28 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 29/03/2020 | 430 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: yes<br>Other specify the comparator: Best Supportive Care / Standard of Care<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Netherlands;Germany;Russian Federation;South Africa;Peru;Brazil;Belgium;Mexico;United States;France→France;United States;Mexico;Belgium;Brazil;Peru;South Africa;Russian Federation;Germany;Netherlands | Clinical Research and Development | | Winzerlaer Strasse 2 | korinna.pilz@inflarx.de | +4989414 1897897 | InflaRX GmbH | Inclusion criteria: <br>Phase II
<br>1. At least 18 years of age or older
<br>2. Clinically evident or otherwise confirmed severe pneumonia as evidenced by at least one of the following criteria:
<br>3. Chest X-ray or computed tomography (CT) scan or magnetic resonance imaging (MRI) with pulmonary infiltrates consistent with pneumonia
<br>4. Clinical history in past 14 days of newly developed severe shortness of breath (> 29 breaths / minute) in the absence of oxygen supply or spontaneous peripheral oxygenation = 92 with need for oxygen supply, or need for non-invasive or invasive ventilation (in conjunction with a positive test for SARS-CoV-2 infection)
<br>5. Oxygenation index at time of enrollment (PaO2 / FiO2) = 250 and = 100 in supine position
<br>6. SARS-CoV-2 infection confirmation (tested positive in last 14 days or test results to be obtained within 24h after enrollment, both with locally available test system).
<br>7. No use OR stop of any corticosteroid treatment at time point of enrollment (topical treatment and systemic dose of = 10mg prednisone / day equivalent allowed)
<br>
<br>Phase III
<br>1. At least 18 years of age or older
<br>2. Patient on invasive mechanical ventilation (but not more than 48h post intubation at time point of first IMP randomization)
<br>3. Patients with a PaO2 / FiO2 ratio of < 200 and > 60 at randomization (one representative measurement within 6h before randomization)
<br>4. SARS-CoV-2 infection confirmation (tested positive in last 14 days before randomization with locally available test system)
<br><br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 320<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 110<br> | Exclusion criteria: <br>Phase II
<br>1. Oxygenation index at time of enrollment (PaO2 / FiO2) < 100 or > 250 in supine position
<br>2. Intubated > 48h at time point of enrollment
<br>3. Patients who demonstrate an improvement in past 24h prior to enrollment in oxygenation and ventilation / support parameters which indicate an expected resolution of lung dysfunction in the next 24h without additional intervention according to judgment of the investigator with one or more of the following parameters present:
<br>4. Improvement in oxygenation index of > 30% relative to previous measure (last 24h in supine position)
<br>5. Extubation if intubated before
<br>6. Known history of chronic obstructive pulmonary disease (COPD) (GOLD category C or D)
<br>7. Known history of chronic dialysis OR received renal replacement therapy in past 14 days
<br>8. Received new other biologic treatment attempt for COVID-19 in the past 14 days
<br>9. Received treatment with a viral replication inhibitor in past 3 days
<br>10. Known hypersensitivity to IFX-1 or any other ingredient of the study medication
<br>11. Known pregnancy
<br>12. Received organ or bone marrow transplantation in past 3 months
<br>13. Known mechanically resuscitation in past 14 days
<br>14. Patient moribund or expected to die in next 12h according to the judgment of the investigator
<br>15. Patients otherwise considered restricted from receiving full supportive care (including ICU support)
<br>16. Existing diagnosis of progressed cancer or other life-limiting disease with life expectancy < 6 months
<br>17. Known to have received anti-cancer therapy for oncological disease in past 4 weeks
<br>18. Known severe congestive heart failure (New York Heart Association [NYHA] Class III-IV; see Appendix 8)
<br>
<br>Phase III
<br>1. Intubated > 48h at time point of first IMP randomization
<br>2. Expected stop of invasive ventilation or expected extubation in the next 24h without additional intervention according to judgment of the investigator
<br>3. Known history of chronic dialysis OR received renal replacement therapy in past 14 days OR anticipated to receive renal replacement therapy within 24h after randomization
<br>4. Known history of progressed COPD as evidenced by use of daily maintenance treatment with long-acting bronchodilators or inhaled/oral corticosteroids for > 2 months
<br>5. Treatment of COVID-19 with investigational antibody treatment(s) which are not approved or not included in locally adopted treatment guidelines (e.g., WHO guidance, National Institutes of Health [NIH] COVID-19 treatment guidelines) for this indication in the past 7 days (Note: Antibody treatment[s] given within past 7 days for pre-existing diseases, other than COVID-19, are allowed.)
<br>6. At time point of randomization, treatment of COVID-19 with investigational treatments which are not approved or not included in locally adopted treatment guidelines for this indication (e.g., WHO guidance, NIH COVID-19 treatment guidelines), including SARS-CoV-2 multiplication inhibitor(s) or immunomodulator(s). (Note: If a locally adopted treatment guideline recommends drugs such as remdesivir, dexamethasone, or anticoagulation, this would be allowed. Adopted guidelines and updates must be documented at study initiation and throughout the conduct of the study.)
<br>7. Received cytokine adsorption therapy in past 3 days
<br>8. Known hypersensitivity to IFX-1 or any other ingredient of the study medication
<br>9. Serum or urine pregnancy test positive before randomization (required for women of childbearing potential)
<br>10. Received organ | Severe pneumonia in context of COVID-19
<br>MedDRA version: 21.1
Level: PT
Classification code 10035737
Term: Pneumonia viral
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08] | <br>Product Name: IFX-1<br>Product Code: vilobelimab<br>Pharmaceutical Form: Concentrate for solution for infusion<br>INN or Proposed INN: IFX-1<br>CAS Number: 2250440-41-4<br>Current Sponsor code: IFX-1<br>Other descriptive name: vilobelimab<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 10-<br>Pharmaceutical form of the placebo: Concentrate for solution for infusion<br>Route of administration of the placebo: Intravenous use<br><br> | Timepoint(s) of evaluation of this end point: Day 28;Primary end point(s): Phase II: <br>The primary endpoint in Phase II was the relative change (%) from baseline (day 1 prior to study drug administration at ± 1h of randomization) in Oxygenation Index (PaO2 / FiO2) in supine position at day 5.<br><br>Phase III: <br>Based on the preliminary interim analysis of efficacy data from Phase II, the primary endpoint chosen for Phase III is 28-day all-cause mortality.<br><br>;Secondary Objective: The secondary objectives of Phase II and Phase III are:<br>• To assess and define other parameters of efficacy<br>• To assess the safety of IFX-1<br>;Main Objective: The primary objective of Phase II was:<br>• To explore the effect of IFX-1 on COVID-19 related severe pneumonia (hypothesis generating)<br><br>The primary objective of Phase III is<br>• To demonstrate the efficacy of IFX-1 to improve survival outcomes of severe COVID-19 pneumonia (confirmative)<br> | | | | Yes | True | parent | |
| +++ | ChiCTR2100052965 | 8 November 2021 | Open label study of the COVID-19 vaccine activating humoral immunity to promote nucleic acid negative conversion | Open label study of the COVID-19 vaccine activating humoral immunity to promote nucleic acid negative conversion | | Beijing Ditan Hospital, Capital Medical University | 2021-11-06 | 20211106 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=136484 | Recruiting | No | 18 | 65 | Both | 2021-11-03 | A group:30;B group:30; | Interventional study | Parallel | 0 | China | Chen Zhihai | | 8 Jingshun Stree East, Chaoyang District, Beijing, China | chenzhihai0001@126.com | +86 13501340403 | Beijing Ditan Hospital, Capital Medical University | Inclusion criteria: 1. Patients diagnosed with COVID-19 diagnosed in accordance with the "COVID-19 Diagnosis and Treatment Plan (Trial Eighth Revised Edition)" formulated by the National Health Commission of the People's Republic of China or those who are asymptomatically infected with COVID-19 diagnosed in accordance with the "COVID-19 Prevention and Control Plan (Eighth Edition)";
<br>2. The age of the subject at the time of signing the informed consent form is 18 to 65 years old (including 18 and 65 years old), and there is no limit to men and women;
<br>3. Respiratory tract samples of confirmed patients with COVID-19 and asymptomatic infections of COVID-19 still tested positive 4 weeks after the first nucleic acid positive.And within 24 hours before screening, any samples confirmed by the laboratory were positive for SARS-CoV-2;
<br>4. The patient's clinical condition is stable, there are no new exudative lesions in chest imaging, and peripheral blood inflammation indicators are normal (such as C-reactive protein, erythrocyte sedimentation rate, serum amyloid A, procalcitonin, etc.);
<br>5. Before enrollment, COVID-19 antibody IgM<50S/CO and IgG<50S/CO;
<br>6. Subjects (including partners) have no pregnancy plan and voluntarily take effective contraceptive measures within 6 months after signing the informed consent form to the study drug administration;
<br>7. The subject agrees to collect nasopharyngeal swabs, sputum and venous blood;
<br>8. The subject can communicate well with the researcher, understand and comply with the requirements of this research, understand and sign the ICF. | Exclusion criteria: 1. The patient's clinical data is incomplete.
<br>2. The investigator believes that any serious concomitant systemic diseases, conditions or obstacles should be prevented from participating in this study:
<br>(1) Have a history of grade III-IV heart failure as defined by the New York Heart Association (NYHA), or a known left ventricular ejection fraction is <30%;
<br>(2) Uncontrolled arrhythmia (such as recurrent and symptomatic ventricular tachycardia, atrial fibrillation with rapid ventricular response or supraventricular tachycardia, II degree or III degree atrioventricular/sinus arrhythmia within 3 months before screening conduction block);
<br>(3) Myocardial infarction (MI), unstable angina (UA), percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) occurred within 3 months before screening;
<br>(4) With uncontrolled hypertension, SBP is > 160 mmHg and/or DBP is > 100 mmHg in sitting position at screening/baseline;
<br>(5) Cerebral thromboembolism, deep vein thrombosis or pulmonary embolism;
<br>(6) Suspected or confirmed serious, active bacteria, fungi, viruses or other infections;
<br>(7) Have a history of chronic obstructive pulmonary disease or bronchial asthma;
<br>(8) Have type 1 diabetes, or newly diagnosed or poorly controlled type 2 diabetes within 6 months before screening (HbA1c > 9.0%);
<br>(9) With active liver disease or liver dysfunction, the ALT or AST level at screening is > 3 times the upper limit of the normal range;
<br>(10) With moderate to severe renal insufficiency, eGFR <= 50ml/min/1.73 m2 at the time of screening;
<br>(11) Have a history of transplantation of important organs (such as heart, lung, liver, kidney, etc.);
<br>(12) Suffering from malignant tumor diseases (excluding malignant tumors that have been cured and have not recurred in the past 5 years, completely resected basal cell and squamous cell skin cancers, and any type of cancer in situ that has been completely resected);
<br>(13) Suffering from systemic or local autoimmune or inflammatory diseases;
<br>(14) Have undergone any major surgery within 3 months before screening: subjects with gastrointestinal perforation, gastrointestinal fistula, abdominal abscess and internal fistula before screening; Subjects with unhealed wounds, active gastric ulcers or fractures;
<br>(15) Subjects with hemoptysis, gastrointestinal bleeding, central nervous system bleeding, epistaxis and other severe or active bleeding within 1 month before screening;
<br>(16) Patients with hereditary bleeding tendency or coagulation dysfunction;
<br>(17) Patients with human immunodeficiency virus (HIV) infection;
<br>3. Those who have been vaccinated against COVID-19 within 3 months before screening;
<br>4. Those who have received SARS-CoV-2 specific monoclonal antibody treatment or have received the history of convalescent COVID-19 plasma treatment;
<br>5. The therapeutic biological agent has been used within 3 months before screening, or the drug is in the elimination period (5 half-life periods) at the time of random administration;Participated in any other clinical studies with investigational drug intervention within 1 month before screening, or the investigational drug is still within the elimination period (5 half-lives) when administered randomly;
<br>6. Those who have had a severe allergic reaction or hypersensitivity to food, drugs, other vaccines and related ingredients in the past, or those with allergies;
<br>7. The auxiliary examination results are obviously abnormal during screening, such as:
<br>(1) Pl | COVID-19 | A group:Recombinant COVID-19 vaccine (CHO cell);B group:COVID-19 inactivated vaccine (Vero cell); | nucleic acid negative conversion time;nucleic acid negative conversion rate; | | | | No | False | | |
| +++ | ChiCTR2100052955 | 8 November 2021 | A clinical trial comparing the immunogenicity of recombinant New Coronavirus vaccine (CHO cells) among people aged 3 to 17 and 18 to 59 years of age. | A clinical trial comparing the immunogenicity of recombinant New Coronavirus vaccine (CHO cells) among people aged 3 to 17 and 18 to 59 years of age. | | Hunan Provincial Center for Disease Control and Prevention | 2021-11-06 | 20211106 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=129737 | Recruiting | No | 3 | 17 | Both | 2021-11-05 | Minor group:400; | Interventional study | Single arm | 2 | China | Li Fangjun | | 450 First Section, Middle Furong Road, Changsha, Hu'nan, China | 646022285@qq.com | +86 13574109585 | | Inclusion criteria: 1. At least 3 ~ 17 years old (both included);
<br>2. The subject voluntarily agrees to participate in the study, and / or the guardian of the subject voluntarily agrees to the child to participate in the study. The subject himself (8-17 years old) and the guardian sign the informed consent form, and can provide valid identity certificates to understand and comply with the requirements of the test protocol;
<br>3. The subject and / or the guardian of the subject have the ability to understand (non illiterate) the research procedures and promise to participate in regular follow-up according to the research requirements;
<br>4. There is no high or medium risk area, overseas travel history or residence history in the past 14 days; In the past 14 days, no confirmed case of New Coronavirus infection, asymptomatic infection or suspected cases had been found. And there was no contact history of patients with fever or respiratory symptoms from high and medium risk areas in the past 14 days; Personnel in non isolation period;
<br>5. Male and female subjects with fertility agreed to take effective contraceptive measures from the beginning of the study to 2 months after the whole vaccination. | Exclusion criteria: 1. The results of physical examination during screening period are abnormal and clinically significant (not suitable for vaccination) as determined by clinicians;
<br>2. Suspected or confirmed fever within 72 hours before enrollment (including the day of enrollment) (> 14 years old, axillary temperature >= 37.3 degrees C; <= 14 years old, axillary temperature >= 37.5 degrees C);
<br>3. Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, etc; Or have a history of the above serious side effects after the use of any vaccine or drug in the past;
<br>4. Had previous history of SARS and SARS-CoV-2.
<br>5. Taking antipyretics or painkillers within 24 hours before the first dose of vaccine;
<br>6. Persons who have been vaccinated with New Coronavirus or inoculated with live attenuated vaccine within 7 days or within 7 days before the first dose of vaccine are inoculated with inward subunit vaccine and / or inactivated vaccine.
<br>7. Have received blood or blood related products, including immunoglobulin, within 3 months before the vaccination of the test vaccine; Or planned use during the study;
<br>8. Persons suffering from the following diseases:
<br>(1) Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days;
<br>(2) Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
<br>(3) History of congenital or acquired immune deficiency or autoimmune diseases or receiving immunomodulator treatment within 6 months, such as immunosuppressive dose of Glucocorticoid (dose reference: equivalent to prednisone 20mg / day, more than one week); Or monoclonal antibody; Or thymosin; Or interferon, etc; However, topical medication (such as ointment, eye drops, inhalants or nasal sprays) is allowed;
<br>(4) It is known that it is diagnosed with infectious diseases, such as active tuberculosis, viral hepatitis present, human immunodeficiency virus infection or Treponema pallidum infection;
<br>(5) Neurological diseases or neurodysplasia (e.g., convulsions, migraines, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficit, Guillain Barre syndrome, encephalomyelitis or transverse myelitis); History of psychosis or family history;
<br>(6) Functional absence of spleen, and absence of spleen or splenectomy for any reason;
<br>(7) There are serious chronic diseases or disease in progress can not be controlled smoothly, such as diabetes, drugs can not control hypertension;
<br>(8) Severe liver and kidney diseases; Respiratory diseases that currently require daily drug treatment (e.g., chronic obstructive pulmonary disease [COPD], asthma) or any treatment for aggravation of respiratory diseases (e.g., aggravation of asthma) in the last 5 years; A history of serious cardiovascular disease (such as congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, cor pulmonale) or myocarditis or pericarditis;
<br>(9) Thrombocytopenia, any coagulation dysfunction or anticoagulant treatment;
<br>(10) Cancer patients (except basal cell carcinoma);
<br>9. Lactating women or pregnant women (including women of childbearing age with positive urine pregnancy test), or women or their partners who have pregnancy plans within 2 months after the whole vaccination of the test | Novel Coronavirus Pneumonia (COVID-19) | Minor group:Experimental vaccination; | SARS-CoV-2 neutralizing antibody;RBD protein binding antibody (IgG) detection; | | | | No | False | | |
| +++ | ChiCTR2100052875 | 8 November 2021 | A randomized, open-label, controlled clinical trial for azvudine in the treatment of new coronavirus delta | A randomized, open-label, controlled clinical trial for azvudine in the treatment of new coronavirus delta | | The First Affiliated Hospital of Zhengzhou University | 2021-11-06 | 20211106 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=135032 | Not Recruiting | No | 18 | 60 | Both | 2021-11-01 | Experimental Group:30;Control group:30; | Interventional study | Parallel | 3 | China | Yu Zujiang | | Department of Infectious Diseases, The First Affiliated Hospital of Zhengzhou University, 1 Jianshe Road East, Zhengzhou, He'nan, China | johnyuem@zzu.edu.cn | +86 18603710022 | The First Affiliated Hospital of Zhengzhou University | Inclusion criteria: 1.Aged 18-60 years(including cut-off value), gender not limited;
<br>2.Sputum/nasal swabs/pharyngeal swabs/lower respiratory tract secretions and other specimens, RT-PCR detected the new coronavirus nucleic acid positive, or the viral gene sequencing was highly homologous with the known Delta virus;
<br>3.Patients diagnosed with novel coronavirus meet the diagnostic criteria of the pneumonia diagnosis and treatment program for novel coronavirus infection issued by National Health commission of the People's Republic of China;
<br>4.Informed consent has been signed. | Exclusion criteria: 1.Known or suspected allergies to the components of azivudine tablets;
<br>2.Women who are breast-feeding during pregnancy or have a family plan during the trial period and within 6 months after the end of the trial;
<br>3.Participating in other clinical trials or using experimental drugs within 12 weeks before administration;
<br>4.Other conditions that not appropriate to be enrolled into this study based on investigator's advise. | Novel Coronavirus Pneumonia | Experimental Group:FNC+Symptomatic treatment (except antiviral treatment);Control group:Antiviral therapy + symptomatic treatment; | time and rate of temperature return to normal;time and rate of improvement of respiratory symptoms and signs (lung rhones, cough, sputum, sore throat, etc.);time and rate of improvement of diarrhea, myalgia, fatigue and other symptoms; time and rate of improvement in pulmonary imaging; novel coronavirus nucleic acid negative conversion time and proportion;time and rate of improvement of oxygenation measurement;improvement time and rate of CD4 count;rate of mild/modorate type to severe type, rate of severe type to critical type;length of hospitalization;mortality;vital signs (body temperature, heart rate, breathing, blood pressure);blood routine, erythrocyte sedimentation rate, C-reactive protein, liver function, kidney function, coagulation function, myocardial enzyme spectrum, myocardial markers, T lymphocyte subsets, pregnancy test;electrocardiogram;adverse events: including type, incidence, severity, time, and drug relevance. The severity is evaluated with reference to CTCAE (version 5.0); | | | | No | False | | |
| +++ | ChiCTR2100052697 | 8 November 2021 | The immunogenicity of medium-dose or high-dose CoronaVac vaccine booster | The immunogenicity of medium-dose or high-dose CoronaVac vaccine administered as a booster dose in adults vaccinated with two doses of CoronaVac vaccine 5-9 months before: a randomized, double-blind, phase IV clinical trial | | Beijing Youan Hospital, Capital Medical University | 2021-11-03 | 20211103 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=136181 | Recruiting | No | 18 | | Both | 2021-10-28 | medium-dose group:170;high-dose group:170; | Interventional study | Parallel | 4 | China | Feng Yingmei | | 8 Xitoutiao, Youanmenwai, Fengtai District, Beijing | yingmeif13@sina.com | +86 10 83997022 | Beijing Youan Hospital, Capital Medical University | Inclusion criteria: 1. Adults aged >= 18 years;
<br>2. Individuals who could justify legal identification;
<br>3. Individuals able to understand and voluntarily sign an informed consent form, and willing to follow the research plan to complete the trial;
<br>4. Individuals vaccinated with two dose of CoronaVac vaccine 5-9 months before. | Exclusion criteria: 1. Individuals with history of COVID-19 (laboratory confirmed);
<br>2. Individuals who have received 3 doses or more of the vaccine against COVID-19;
<br>3. Individuals with severe adverse reactions in the basic immunity of the new crown vaccine, such as urticaria, dyspnea, and angioedema;
<br>4. Individuals with autoimmune diseases (such as systemic lupus erythematosus) or in an immunodeficiency/immunosuppressive state (such as AIDS, after organ transplantation);
<br>5. Individuals with severe chronic diseases, such as severe cardiovascular disease, high blood pressure that cannot be controlled by drugs, diabetes, liver and kidney disease, malignant tumors, etc.;
<br>6. Individuals with severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
<br>7. Individuals with abnormal coagulation function (such as deficiency of coagulation factors, coagulopathy, abnormal platelet) or obvious bruising or coagulation disorder diagnosed by a doctor;
<br>8. Individuals who received immunosuppressant therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray therapy for allergic rhinitis, and surface corticosteroid therapy for acute non-complicated dermatitis) in the past 6 months, or plans to receive the above treatment during the study period;
<br>9. Individuals with history of long-term alcohol or drug abuse;
<br>10. Individuals who received blood products within 3 months, or plans to receive the above treatment during the study period;
<br>11. Individuals received other investigational drugs within 30 days;
<br>12. Individuals received live attenuated vaccine against COVID-19 within 14 days, or received subunit or inactivated vaccine against COVID-19 within 7 days;
<br>13. Individuals with various acute or acute Onset of chronic disease in the past 7 days;
<br>14. Individuals with axillary temperature > 37.0?;
<br>15. Individuals who participated in other clinical trials and being during the follow-up period, or plans to participate in other clinical trials during the study period;
<br>16. Individuals with any other factors that are not suitable for participating in the clinical trial based on the judgment of the investigator. | COVID-19 | medium-dose group:medium-dose CoronaVac vaccine booster;high-dose group:high-dose CoronaVac vaccine booster; | Serum neutralizing antibody; | | | | No | False | | |
| → | ChiCTR2100051688 | 26 October 2021→8 November 2021 | Clinical Study on the Combined Application of Hymecromone Tablets in the Treatment of SARS-CoV-2 Infection | Clinical Study on the Combined Application of Hymecromone Tablets in the Treatment of SARS-CoV-2 Infection | | Shanghai Public Health Clinical Center | 2021-09-30 | 20210930 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=58343 | Recruiting | No | | | Both | 2020-07-25 | conventional treatment group:150;conventional treatment combined with hymecromone tablets group:150; | Interventional study | Parallel | 0 | China | Lu Hongzhou, Yu Wenqiang | | 2901 Caolang Road, Jinshan District, Shanghai, China | luhongzhou@shphc.org.cn | +86 21 37990333; +86 21 54237978 | Shanghai Public Health Clinical Center | Inclusion criteria: All inclusion criteria must be met to qualify for inclusion:
<br>1) The age should be over 18 years old and under 70 years old, with no gender limit. Those who meet the diagnostic criteria of clinical pneumonia
<br>2) According to the clinical diagnosis of viral pneumonia:
<br>A. Fever (oral temperature >= 38 degrees C, or axillary temperature >= 37.5 degrees C; or fever history within 24 hours before baseline, whether taking antipyretics or not; or having fever symptoms within 48 hours before baseline), with or without respiratory symptoms (respiratory rate > 30 beats / min);
<br>B. White blood cell count was normal or low, with or without thrombocytopenia;
<br>C. Chest imaging (chest CT): unilateral or bilateral chest imaging showed multiple (at least 2 lesions) or diffuse patchy or ground glass infiltration (with or without consolidation);
<br>3) SARS-COV-2 is positive for pathogens. After respiratory virus screening, oropharyngeal test pieces with one or more virus nucleic acid positive can be selected into the group. The SARS-COV-2 in the samples were further evaluated by qPCR according CT valune;
<br>4) Prior to the start of the study, a written informed letter should be signed (for the incompetent subjects, if the researcher thinks that it is in their own interests to participate in the trial, the informed consent shall be signed by the legal guardian of the subject, and it shall be explained in the original medical record and other relevant documents).→Inclusion criteria: All inclusion criteria must be met to qualify for inclusion:
<br>1. The age should be over 18 years old and under 70 years old, with no gender limit. Those who meet the diagnostic criteria of clinical pneumonia
<br>2. According to the clinical diagnosis of viral pneumonia:
<br>(1) Fever (oral temperature >= 38 degrees C, or axillary temperature >= 37.5 degrees C; or fever history within 24 hours before baseline, whether taking antipyretics or not; or having fever symptoms within 48 hours before baseline), with or without respiratory symptoms (respiratory rate > 30 beats / min);
<br>(2) White blood cell count was normal or low, with or without thrombocytopenia;
<br>(3) Chest imaging (chest CT): unilateral or bilateral chest imaging showed multiple (at least 2 lesions) or diffuse patchy or ground glass infiltration (with or without consolidation);
<br>3. SARS-COV-2 is positive for pathogens. After respiratory virus screening, oropharyngeal test pieces with one or more virus nucleic acid positive can be selected into the group. The SARS-COV-2 in the samples were further evaluated by qPCR according CT valune;
<br>4. Prior to the start of the study, a written informed letter should be signed (for the incompetent subjects, if the researcher thinks that it is in their own interests to participate in the trial, the informed consent shall be signed by the legal guardian of the subject, and it shall be explained in the original medical record and other relevant documents). | Exclusion criteria: Those who meet any of the following criteria shall not be included in the group:
<br>1) There were serious noninfectious pulmonary diseases, including pulmonary tumor, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophilic infiltration and pulmonary vasculitis;
<br>2) Severe liver and kidney dysfunction:
<br>a) ALT and AST value were more than 10 times higher than the upper limit of normal value;
<br>b) Serum creatinine value was more than 1.5 times higher than the upper limit of normal value;
<br>c) Total bilirubin was more than 2 times the upper limit of normal value;
<br>3) Patients with biliary obstruction;
<br>4) Pregnant women (urine or serum pregnancy test positive) or lactating women;
<br>5) Other subjects considered unsuitable by the researchers for this trial, or the researchers think that there may be any situation that may increase the risk of subjects or interfere with the clinical trial.→Exclusion criteria: Those who meet any of the following criteria shall not be included in the group:
<br>1. There were serious noninfectious pulmonary diseases, including pulmonary tumor, pulmonary edema, atelectasis, pulmonary embolism, pulmonary eosinophilic infiltration and pulmonary vasculitis;
<br>2. Severe liver and kidney dysfunction:
<br>(1) ALT and AST value were more than 10 times higher than the upper limit of normal value;
<br>(2) Serum creatinine value was more than 1.5 times higher than the upper limit of normal value;
<br>(3) Total bilirubin was more than 2 times the upper limit of normal value;
<br>3. Patients with biliary obstruction;
<br>4. Pregnant women (urine or serum pregnancy test positive) or lactating women;
<br>5. Other subjects considered unsuitable by the researchers for this trial, or the researchers think that there may be any situation that may increase the risk of subjects or interfere with the clinical trial. | Corona Virus Disease 2019→Novel Coronavirus Pneumonia (COVID-19) | conventional treatment group:conventional treatment;conventional treatment combined with hymecromone tablets group:conventional treatment combined with hymecromone tablets treatment; | Hyaluronic acid;Virus negative time; | | | | No | False | | |
| → | ChiCTR2100045160 | 17 May 2021→8 November 2021 | Evaluation of Immunization Effect of 2019-nCoV Inactivated Vaccine | Evaluation of Immunization Effect of 2019-nCoV Inactivated Vaccine | | Chongqing General Hospital | 2021-04-07 | 20210407 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=123525 | Not Recruiting→Recruiting | No | 18 | 59 | Both | 2021-02-01 | Case series:100;→2019-nCoV Inactivated Vaccine group:50;non vaccinated group:50; | Observational study | Single arm→Factorial | N/A | China | Pu Liao→Liao Pu | | 104 Pibashan Street, Yuzhong District, Chongqing, China | liaopu@sina.com | +86 023-63519127→+86 23 63519127 | Chongqing General Hospital | Inclusion criteria: (1) Healthy subjects aged 18-59 years;
<br>(2) Gender: male or non-pregnant or non-lactating female;
<br>(3) No history of major diseases, history of drug allergy and vaccination Allergy history;
<br>(4) No history of new coronary pneumonia or infection history, holding a health code "green code";
<br>(5) Able to complete the two-month clinical research follow-up.→Inclusion criteria: 1.Healthy subjects aged 18-59 years;
<br>2.Gender: male or non-pregnant or non-lactating female;
<br>3.No history of major diseases, history of drug allergy and vaccination Allergy history;
<br>4.No history of new coronary pneumonia or infection history, holding a health code "green code";
<br>5.Able to complete the two-month clinical research follow-up. | Exclusion criteria: (1) Those who are allergic to any component of the vaccine, and those who have had severe allergic reactions to the vaccine in the past (such as anaphylactic shock, acute allergic reactions, urticaria, skin eczema, dyspnea, angioedema or abdominal pain);
<br>(2) sufferers Acute disease, severe chronic disease, acute onset of chronic disease, and fever;
<br>(3) Pregnant women and lactating women, those who have a childbirth plan within 3 months of vaccination;
<br>(4) Have a history or family history of convulsions, epilepsy, encephalopathy or mental illness; suffer from uncontrolled epilepsy and other progressive neurological diseases Those with a history of Guillain-Barre syndrome;
<br>(5) Those who have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
<br>(6) Known or suspected Patients with severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors;
<br>(7) Those who use immunosuppressive drugs such as anti-tumor drugs;
<br>(8) Those who suffer from thrombocytopenia or bleeding disorders;
<br>(9) Clinicians Or the vaccination staff believes that they are not suitable for vaccination against the COVID-19.→Exclusion criteria: 1. Those who are allergic to any component of the vaccine, and those who have had severe allergic reactions to the vaccine in the past (such as anaphylactic shock, acute allergic reactions, urticaria, skin eczema, dyspnea, angioedema or abdominal pain);
<br>2. Sufferers Acute disease, severe chronic disease, acute onset of chronic disease, and fever;
<br>3. Pregnant women and lactating women, those who have a childbirth plan within 3 months of vaccination;
<br>4. Have a history or family history of convulsions, epilepsy, encephalopathy or mental illness; suffer from uncontrolled epilepsy and other progressive neurological diseases Those with a history of Guillain-Barre syndrome;
<br>5. Those who have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
<br>6. Known or suspected Patients with severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors;
<br>7. Those who use immunosuppressive drugs such as anti-tumor drugs;
<br>8. Those who suffer from thrombocytopenia or bleeding disorders;
<br>9. Clinicians Or the vaccination staff believes that they are not suitable for vaccination against the COVID-19. | Novel Coronavirus Pneumonia (COVID-19) | Case series:2019-nCoV Inactivated Vaccine;→2019-nCoV Inactivated Vaccine group:Nil;non vaccinated group:Nil; | 2019-nCoV related antibodies;Cytokines;Serum peptide fingerprint;Proportion of T lymphocyte subsets;CD4/CD8 ratio; | | | | No | False | | |
| → | ChiCTR2100045109 | 17 May 2021→8 November 2021 | The Impact of Timing of Vaccination on the Immune Reaction to Vaccine against SARS-CoV-2 | The Impact of Timing of Vaccination on the Immune Reaction to Vaccine against SARS-CoV-2 | | The First Affiliated Hospital, Sun Yat-Sen University | 2021-04-07 | 20210407 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=124650 | Recruiting | No | 18 | 59 | Both | 2021-04-09 | Intervention group:236;Control group:236; | Interventional study | Parallel | N/A | China | Sui Peng | | 58 Second Zhongshan Road, Guangzhou, Guangdong, China | pengsui@vip.163.com | +86 13660652577 | The First Affiliated Hospital, Sun Yat-Sen University | Inclusion criteria: aged 18-59 years old→Inclusion criteria: Aged 18-59 years. | Exclusion criteria: 1. Those who are allergic to any component of the vaccine, and those who have history of severe allergic reactions to the vaccine, such as acute allergic reactions, urticaria, skin eczema, dyspnea, angioedema or abdominal pain;
<br>2. Those with fever or those who suffer from acute diseases or severe chronic diseases in the acute stage of onset;
<br>3. Pregnant women, lactating women, or having a pregnancy plan within 3 months;
<br>4. Patients with a history or family history of convulsions, epilepsy, encephalopathy or mental illness; Patients with uncontrolled epilepsy and other progressive neurological diseases; Patients with a history of Guillain-Barré syndrome;
<br>5. Those who have been diagnosed with congenital or acquired immunodeficiency HIV infected lymphoma leukemia or other autoimmune diseases;
<br>6. Those who have severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases and malignant tumors;
<br>7. A history of COVID-19 infection;
<br>8. Patients who take medicine affecting the immune function, such as immunosuppressant agents or immunopotentiators or glucocorticoids (>=10mg prednisone or other equivalent glucocorticoids) within one month before enrollment;
<br>9. Those who are considered unsuitable for vaccination by clinicians. | Novel Coronavirus Pneumonia (COVID-19) | Intervention group:vaccinated in the morning;Control group:vaccinated in the afternoon; | SARS-CoV-2 RBD specific antibody level; | | | | Yes | False | | |
| → | ChiCTR2100045108 | 17 May 2021→8 November 2021 | A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Subjects→A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Subjects | A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Subjects →A Randomized, Double-Blind, Placebo-Controlled Phase I Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Subjects | | Guangdong Provincial Center for Disease Control and Prevention/ Gaozhou Municipal Center for Disease Control and Prevention | 2021-04-07 | 20210407 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=124140 | Recruiting | No | 18 | / | Both | 2021-02-22 | Group A: 10-ug youth (18-59 years) group:30;Group B: 25-ug youth (18-59 years) group:30;Group C: 50-ug youth (18-59 years) group:30;Group D: 10-ug elder (>=60 years) group:30;Group E: 25-ug elder (>=60 years) group:30;Group F: 50-ug elder (>=60 years) gr | Prevention | Parallel | 1 | China | Zhonghui Xu | | 38 Chuangye Road North, Jinwan District, Zhuhai, Guangdong, China | xuzhonghui@livzon.cn | +86 18627028600 | Livzon Mabpharm Inc. | Inclusion criteria: Subjects who comply with the following criteria will be enrolled:
<br>1) Willing to participate in the study with informed consent;
<br>2) Health male or female adults (i.e. aged 18 years and above);
<br>3) BMI within 18-28 kg/m2 (including both boundaries);
<br>4) Without a history of traveling or residence in domestic areas of high and moderate pandemic risk, overseas or epidemic areas, nor a history of contact with confirmed, asymptomatic or suspected COVID-19 cases, or patients coming from areas of high and moderate pandemic risk who have fever or respiratory tract symptoms within the past 14 days; being not in quarantine and not living in an area with cluster of COVID-19 cases;
<br>5) Males with fertility and women of childbearing potential who are willing to take effective contraceptive measures during the period from the date of signing the informed consent to 12 months after the last dose of the investigational vaccines; women of childbearing potential refer to premenopausal women and women within 2 years after menopause. Women of childbearing potential should test negative for pregnancy within 7 days prior to the first dose of the investigational vaccines;
<br>6) Willing to abide by the study protocol by cooperatively receiving required examinations.→Inclusion criteria: Subjects who comply with the following criteria will be enrolled:
<br>1. Willing to participate in the study with informed consent;
<br>2. Health male or female adults (i.e. aged 18 years and above);
<br>3. BMI within 18-28 kg/m2 (including both boundaries);
<br>4. Without a history of traveling or residence in domestic areas of high and moderate pandemic risk, overseas or epidemic areas, nor a history of contact with confirmed, asymptomatic or suspected COVID-19 cases, or patients coming from areas of high and moderate pandemic risk who have fever or respiratory tract symptoms within the past 14 days; being not in quarantine and not living in an area with cluster of COVID-19 cases;
<br>5. Males with fertility and women of childbearing potential who are willing to take effective contraceptive measures during the period from the date of signing the informed consent to 12 months after the last dose of the investigational vaccines; women of childbearing potential refer to premenopausal women and women within 2 years after menopause. Women of childbearing potential should test negative for pregnancy within 7 days prior to the first dose of the investigational vaccines;
<br>6. Willing to abide by the study protocol by cooperatively receiving required examinations. | Exclusion criteria: Subjects who meet any of the following criteria will be excluded:
<br>1) Confirmed or asymptomatic COVID-19 cases;
<br>2) Positive SARS-CoV-2 nucleic acid test;
<br>3) Positive SARS-CoV-2 IgG or IgM test (reference to nucleic acid test and chest CT if necessary);
<br>4) History of SARS;
<br>5) Fever (axillary temperature = 37.3?) or other acute diseases, or in the acute phase of chronic diseases within 14 days prior to the signing of the informed consent form;
<br>6) With significantly abnormal laboratory test results during screening, including biochemical profile, hematology, urinalysis, coagulation function and antinuclear antibody;
<br>7) Past history of allergies to vaccines (e.g., acute allergic reactions, hives, skin eczema, dyspnea, angioneurotic edema, or abdominal pain), or allergic to any known ingredients of COVID-19 vaccines;
<br>8) History of drug abuse/dependence within 1 year prior to signing the informed consent;
<br>9) Past history of alcoholism;
<br>10) Having severe chronic diseases that cannot be controlled by drugs (individuals = 60 years): chronic respiratory diseases (including moderate to severe asthma, COPD, pulmonary fibrosis), uncontrolled hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg), severe cardiovascular diseases (including cardiac failure, coronary artery disease, cardiomyopathy), chronic kidney disease, cancer, diabetes (unacceptable glycemia control or serious diabetic complications);
<br>11) History of congenital or acquired angioneurotic edema;
<br>12) Any confirmed or suspected immunosuppressive or immunodeficiency disorder, including HIV infection and asplenia; recurrent severe infections and administration of immunosuppressive drugs during the past 6 months, excluding topical steroids or short-term oral steroids (<14 days);
<br>13) History of autoimmune diseases, excluding mild psoriasis, controllable autoimmune thyroid disease, vitiligo, or stable celiac disease that does not require immunosuppressive or immunomodulatory therapy;
<br>14) Pregnant women or women expected to get pregnant within 12 months after the last dose and breastfeeding women;
<br>15) At high risk of SARS-CoV-2 exposure (such as medical staff, health care providers in direct contact with patients);
<br>16) Having received SARS-CoV-2 vaccines for emergency use or approved SARS-CoV-2 vaccines;
<br>17) Positive screening test results (Hepatitis C virus antibody, treponema pallidum antibody, HIV antibody);
<br>18) Administration of a live attenuated vaccine within 1 month prior to the investigational vaccine dose, or other vaccines within 14 days prior to the investigational vaccine dose;
<br>19) Administration of immunoglobulins and/or any blood products within 3 months prior to the investigational vaccine dose;
<br>20) Administration of other investigational drugs within 6 months prior to the investigational vaccine dose;
<br>21) Other scenarios that may be medically, psychologically or socially contradicted with the study protocol at the investigators discretion or preclude informed consents of the subjects.→Exclusion criteria: Subjects who meet any of the following criteria will be excluded:
<br>1. Confirmed or asymptomatic COVID-19 cases;
<br>2. Positive SARS-CoV-2 nucleic acid test;
<br>3. Positive SARS-CoV-2 IgG or IgM test (reference to nucleic acid test and chest CT if necessary);
<br>4. History of SARS;
<br>5. Fever (axillary temperature >= 37.3 degrees C) or other acute diseases, or in the acute phase of chronic diseases within 14 days prior to the signing of the informed consent form;
<br>6. With significantly abnormal laboratory test results during screening, including biochemical profile, hematology, urinalysis, coagulation function and antinuclear antibody;
<br>7. Past history of allergies to vaccines (e.g., acute allergic reactions, hives, skin eczema, dyspnea, angioneurotic edema, or abdominal pain), or allergic to any known ingredients of COVID-19 vaccines;
<br>8. History of drug abuse/dependence within 1 year prior to signing the informed consent;
<br>9. Past history of alcoholism;
<br>10. Having severe chronic diseases that cannot be controlled by drugs (individuals >= 60 years): chronic respiratory diseases (including moderate to severe asthma, COPD, pulmonary fibrosis), uncontrolled hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >= 90 mmHg), severe cardiovascular diseases (including cardiac failure, coronary artery disease, cardiomyopathy), chronic kidney disease, cancer, diabetes (unacceptable glycemia control or serious diabetic complications);
<br>11. History of congenital or acquired angioneurotic edema;
<br>12. Any confirmed or suspected immunosuppressive or immunodeficiency disorder, including HIV infection and asplenia; recurrent severe infections and administration of immunosuppressive drugs during the past 6 months, excluding topical steroids or short-term oral steroids (< 14 days);
<br>13. History of autoimmune diseases, excluding mild psoriasis, controllable autoimmune thyroid disease, vitiligo, or stable celiac disease that does not require immunosuppressive or immunomodulatory therapy;
<br>14. Pregnant women or women expected to get pregnant within 12 months after the last dose and breastfeeding women;
<br>15. At high risk of SARS-CoV-2 exposure (such as medical staff, health care providers in direct contact with patients);
<br>16. Having received SARS-CoV-2 vaccines for emergency use or approved SARS-CoV-2 vaccines;
<br>17. Positive screening test results (Hepatitis C virus antibody, treponema pallidum antibody, HIV antibody);
<br>18. Administration of a live attenuated vaccine within 1 month prior to the investigational vaccine dose, or other vaccines within 14 days prior to the investigational vaccine dose;
<br>19. Administration of immunoglobulins and/or any blood products within 3 months prior to the investigational vaccine dose;
<br>20. Administration of other investigational drugs within 6 months prior to the investigational vaccine dose;
<br>21. Other scenarios that may be medically, psychologically or socially contradicted with the study protocol at the investigators discretion or preclude informed consents of the subjects. | Novel Coronavirus Pneumonia (COVID-19) | Group A: 10-ug youth (18-59 years) group:All subjects are given one dose of V-01 or placebo on Days 0 and 21.;Group B: 25-ug youth (18-59 years) group:All subjects are given one dose of V-01 or placebo on Days 0 and 21.;Group C: 50-ug youth (18-59 years) group:All subjects are given one dose of V-01 or placebo on Days 0 and 21.;Group D: 10-ug elder (>=60 years) group:All subjects are given one dose of V-01 or placebo on Days 0 and 21.;Group E: 25-ug elder (>=60 years) group:All subjects are given one dose of V-01 or placebo on Days 0 and 21.;Group F: 50-ug elder (>=60 years) group:All subjects are given one dose of V-01 or placebo on Days 0 and 21.; | Safety; | | | | No | False | | |
| → | ChiCTR2100045107 | 17 May 2021→8 November 2021 | A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Subjects→A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Subjects | A Randomized, Double-blind, Placebo-controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Subjects →A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of Recombinant SARS-CoV-2 Fusion Protein Vaccine (V-01) in Healthy Subjects | | Guangdong Provincial Center for Disease Control and Prevention/ Gaozhou Municipal Center for Disease Control and Prevention | 2021-04-07 | 20210407 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=124702 | Not Recruiting→Recruiting | No | 18 | 100 | Both | 2021-03-28 | Group X: Two-dose 10-ug youth (18-59 years) group and two-dose 25-ug youth (18-59 years) group:280;Group Y: Two-dose 10-ug elder (>=60 years) group and two-dose 25-ug elder (>=60 years) group:280;Group Z: One-dose 50-ug youth (18-59 years) group:160;Grou | Prevention | Parallel | 2 | China | Zhonghui Xu→Xu Zhonghui | | 38 Chuangye Road North, Jinwan District, Zhuhai, Guangdong, China | xuzhonghui@livzon.cn | +86 18627028600 | Livzon Mabpharm Inc. | Inclusion criteria: Subjects who comply with the following criteria will be enrolled:
<br>1) Willing to participate in the study with informed consent;
<br>2) Health male or female adults (i.e. aged 18 years and above);
<br>3) Without a history of traveling or residence in domestic areas of high and moderate pandemic risk, overseas or epidemic areas, nor a history of contact with confirmed, asymptomatic or suspected COVID-19 cases, or patients coming from areas of high and moderate pandemic risk who have fever or respiratory tract symptoms within the past 14 days; being not in quarantine and not living in an area with cluster of COVID-19 cases;
<br>4) Males with fertility and women of childbearing potential who are willing to take effective contraceptive measures during the period from the date of signing the informed consent to 12 months after the last dose of the investigational vaccines; women of childbearing potential refer to premenopausal women and women within 2 years after menopause. Women of childbearing potential should test negative for pregnancy within 7 days prior to the first dose of the investigational vaccines;
<br>5) Willing to abide by the study protocol by cooperatively receiving required examinations.→Inclusion criteria: Subjects who comply with the following criteria will be enrolled:
<br>1. Willing to participate in the study with informed consent;
<br>2. Health male or female adults (i.e. aged 18 years and above);
<br>3. Without a history of traveling or residence in domestic areas of high and moderate pandemic risk, overseas or epidemic areas, nor a history of contact with confirmed, asymptomatic or suspected COVID-19 cases, or patients coming from areas of high and moderate pandemic risk who have fever or respiratory tract symptoms within the past 14 days; being not in quarantine and not living in an area with cluster of COVID-19 cases;
<br>4. Males with fertility and women of childbearing potential who are willing to take effective contraceptive measures during the period from the date of signing the informed consent to 12 months after the last dose of the investigational vaccines; women of childbearing potential refer to premenopausal women and women within 2 years after menopause. Women of childbearing potential should test negative for pregnancy within 7 days prior to the first dose of the investigational vaccines;
<br>5. Willing to abide by the study protocol by cooperatively receiving required examinations. | Exclusion criteria: Subjects who meet any of the following criteria will be excluded:
<br>1) Confirmed or asymptomatic COVID-19 cases;
<br>2) Positive SARS-CoV-2 nucleic acid test;
<br>3) Positive SARS-CoV-2 IgG or IgM test (reference to nucleic acid test and chest CT if necessary);
<br>4) History of SARS;
<br>5) Fever (axillary temperature >=37.3 degree C) or other acute diseases, or in the acute phase of chronic diseases within 14 days prior to the signing of the informed consent form;
<br>6) Past history of allergies to vaccines (e.g., acute allergic reactions, hives, skin eczema, dyspnea, angioneurotic edema, or abdominal pain), or allergic to any known ingredients of COVID-19 vaccines;
<br>7) History of drug abuse/dependence within 1 year prior to signing the informed consent;
<br>8) Past history of alcoholism;
<br>9) Having severe chronic diseases that cannot be controlled by drugs (individuals = 60 years): chronic respiratory diseases (including moderate to severe asthma, COPD, pulmonary fibrosis), uncontrolled hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >=90 mmHg), severe cardiovascular diseases (including cardiac failure, coronary artery disease, cardiomyopathy), chronic kidney disease, cancer, diabetes (unacceptable glycemia control or serious diabetic complications);
<br>10) History of congenital or acquired angioneurotic edema;
<br>11) Any confirmed or suspected immunosuppressive or immunodeficiency disorder, including HIV infection and asplenia; recurrent severe infections and administration of immunosuppressive drugs during the past 6 months, excluding topical steroids or short-term oral steroids (<14 days);
<br>12) History of autoimmune diseases, excluding mild psoriasis, controllable autoimmune thyroid disease, vitiligo, or stable celiac disease that does not require immunosuppressive or immunomodulatory therapy;
<br>13) Pregnant women or women expected to get pregnant within 12 months after the last dose and breastfeeding women;
<br>14) At high risk of SARS-CoV-2 exposure (such as medical staff, health care providers in direct contact with patients);
<br>15) Having received SARS-CoV-2 vaccines for emergency use or approved SARS-CoV-2 vaccines;
<br>16) Having been diagnosed with congenital or acquired immunodeficiency, or suspected of systemic diseases that may interfere with the progress or completion of the study, such as tuberculosis, viral hepatitis, human immunodeficiency virus (HIV) infection, syphilis infection, etc.;
<br>17) Administration of a live attenuated vaccine within 1 month prior to the investigational vaccine dose, or other vaccines within 14 days prior to the investigational vaccine dose;
<br>18) Administration of immunoglobulins and/or any blood products within 3 months prior to the investigational vaccine dose;
<br>19) Administration of other investigational drugs within 6 months prior to the investigational vaccine dose;
<br>2O) Other scenarios that may be medically, psychologically or socially contradicted with the study protocol at the investigators discretion or preclude informed consents of the subjects.→Exclusion criteria: Subjects who meet any of the following criteria will be excluded:
<br>1. Confirmed or asymptomatic COVID-19 cases;
<br>2. Positive SARS-CoV-2 nucleic acid test;
<br>3. Positive SARS-CoV-2 IgG or IgM test (reference to nucleic acid test and chest CT if necessary);
<br>4. History of SARS;
<br>5. Fever (axillary temperature >= 37.3 degrees C) or other acute diseases, or in the acute phase of chronic diseases within 14 days prior to the signing of the informed consent form;
<br>6. Past history of allergies to vaccines (e.g., acute allergic reactions, hives, skin eczema, dyspnea, angioneurotic edema, or abdominal pain), or allergic to any known ingredients of COVID-19 vaccines;
<br>7. History of drug abuse/dependence within 1 year prior to signing the informed consent;
<br>8. Past history of alcoholism;
<br>9. Having severe chronic diseases that cannot be controlled by drugs (individuals >= 60 years): chronic respiratory diseases (including moderate to severe asthma, COPD, pulmonary fibrosis), uncontrolled hypertension (systolic blood pressure >=140 mmHg and/or diastolic blood pressure >= 90 mmHg), severe cardiovascular diseases (including cardiac failure, coronary artery disease, cardiomyopathy), chronic kidney disease, cancer, diabetes (unacceptable glycemia control or serious diabetic complications);
<br>10. History of congenital or acquired angioneurotic edema;
<br>11. Any confirmed or suspected immunosuppressive or immunodeficiency disorder, including HIV infection and asplenia; recurrent severe infections and administration of immunosuppressive drugs during the past 6 months, excluding topical steroids or short-term oral steroids (<14 days);
<br>12. History of autoimmune diseases, excluding mild psoriasis, controllable autoimmune thyroid disease, vitiligo, or stable celiac disease that does not require immunosuppressive or immunomodulatory therapy;
<br>13. Pregnant women or women expected to get pregnant within 12 months after the last dose and breastfeeding women;
<br>14. At high risk of SARS-CoV-2 exposure (such as medical staff, health care providers in direct contact with patients);
<br>15. Having received SARS-CoV-2 vaccines for emergency use or approved SARS-CoV-2 vaccines;
<br>16. Having been diagnosed with congenital or acquired immunodeficiency, or suspected of systemic diseases that may interfere with the progress or completion of the study, such as tuberculosis, viral hepatitis, human immunodeficiency virus (HIV) infection, syphilis infection, etc.;
<br>17. Administration of a live attenuated vaccine within 1 month prior to the investigational vaccine dose, or other vaccines within 14 days prior to the investigational vaccine dose;
<br>18. Administration of immunoglobulins and/or any blood products within 3 months prior to the investigational vaccine dose;
<br>19. Administration of other investigational drugs within 6 months prior to the investigational vaccine dose;
<br>2O. Other scenarios that may be medically, psychologically or socially contradicted with the study protocol at the investigators discretion or preclude informed consents of the subjects. | Novel Coronavirus Pneumonia (COVID-19) | Group X: Two-dose 10-ug youth (18-59 years) group and two-dose 25-ug youth (18-59 years) group:All the subjects are administrated V-01 or placebo on Days 0 and Day 21 at the deltoid muscle in the upper arm and tested for safety, tolerance and immunogenicity as per the schedule described in the study protocol.;Group Y: Two-dose 10-ug elder (>=60 years) group and two-dose 25-ug elder (>=60 years) group:All the subjects are administrated V-01 or placebo on Days 0 and Day 21 at the deltoid muscle in the upper arm and tested for safety, tolerance and immunogenicity as per the schedule described in the study protocol.;Group Z: One-dose 50-ug youth (18-59 years) group:All the subjects are administrated V-01 or placebo on Day 0 and at the deltoid muscle in the upper arm and tested for safety, tolerance and immunogenicity as per the schedule described in the study protocol.;Group W: One-dose 50-ug elder (>=60 years) group:All the subjects are administrated V-01 or placebo on Day 0 at the deltoid muscle in the upper arm and tested for safety, tolerance and immunogenicity as per the schedule described in the study protocol.; | 1.␣Positive conversion rate of serum anti-SARS-CoV-2 RBD protein antibody, and its geometric mean titer (GMT) and geometric mean fold increase (GMI); 2. Positive conversion rate of serum anti-SARS-CoV-2 neutralizing antibody, and its GMI;→1.Positive conversion rate of serum anti-SARS-CoV-2 RBD protein antibody, and its geometric mean titer (GMT) and geometric mean fold increase (GMI); 2. Positive conversion rate of serum anti-SARS-CoV-2 neutralizing antibody, and its GMI; | | | | No | False | | |
| +++ | ChiCTR2100045088 | 8 November 2021 | Aerosols Produced by Painless Gastroscopes and Ordinary Gastroscopes: A Quantitative Evaluation | Aerosols Produced by Painless Gastroscopes and Ordinary Gastroscopes: A Quantitative Evaluation | | Zhongnan Hospital | 2021-04-06 | 20210406 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=124407 | Recruiting | No | 18 | 70 | Both | 2021-04-10 | Ordinary gastrocopy group:100;Painless gastroscopy group:100; | Observational study | Non randomized control | N/A | China | Zhao Qiu | | 169 Lake Road East, Wuchang District, Wuhan, Hubei | zhaoqiu@163.com | +86 13761491681 | Wuhan Universitity | Inclusion criteria: 1.Patients aged from 18 to 70 years;
<br>2.Patients requiring gastroscopy;
<br>3.Patients willing to participate in this study. | Exclusion criteria: 1.Patients with severe cardiopulmonary insufficiency;
<br>2.Critically ill patients such as shock or digestive tract perforation are suspected;
<br>3.Patients with mental illness who cannot cooperate with the examination. | COVID-19 aerosols | Ordinary gastrocopy group:Ordinary gastrocopy;Painless gastroscopy group:Painless gastroscopy; | Aerosols; | | | | Yes | False | | |
| +++ | CTRI/2021/09/036099 | 8 November 2021 | Doxazosin to Prevent Severe COVID-19 (CALM-COVID Trial) | Alpha-1 Adrenergic Receptor Antagonism to Prevent Cytokine Storm Syndrome and Severe COVID-19: A Pragmatic Randomized, Double-Blind Phase 2 Study Comparing the Efficacy of Doxazosin vs. Placebo for SARS-CoV-2 infection. - CALM-COVID Trial | | Johns Hopkins University School of Medicine | 01-09-2021 | 20210901 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59447 | Not Recruiting | No | | | | 06-09-2021 | 994 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 2 | India | Dr Pallavi Ghana | | R and D Department
Research Informatics Division
University of Agricultural Sciences
Convention Centre
Veterinary College Campus
Bellary Road Bengaluru | aditi.c@strandls.com | | Strand Life Sciences Private Limited | Inclusion criteria: 1. Subjects must be 45 years of age or older <br/ ><br>2. Subjects have symptoms of COVID-19 and have Mild disease not requiring hospitalization <br/ ><br>3. Subjects have an approved positive test for SARS-CoV-2 and symptom onset within 6 days of start of treatment <br/ ><br>4. Subject must have indicated interest in participating in the clinical trial and provided informed consent to participate in the CALM-COVID trial specifically. | Exclusion criteria: 1. Female subjects who identify as pregnant, self-reported positive pregnancy testing, or who are breastfeeding during the study period <br/ ><br>2. Age >85 years <br/ ><br>3. Subjects with COVID-19 and Moderate or Severe disease <br/ ><br>4. Subjects receiving supplemental oxygen at baseline <br/ ><br>5. Already receiving an effective therapy for early COVID-19 (monoclonal antibodies) at time of enrollment or enrolled in another clinical treatment trial for COVID-19 <br/ ><br>6. Subjects who have been administered one or more doses of any approved SARS-CoV-2 vaccine. <br/ ><br>7. Known history of known orthostatic hypotension, unexplained history of syncope, postural orthostatic tachycardia syndrome (POTS), neurally-mediated hypotension (within the last year), heart failure (NYHA III or IV or exacerbation in past 2 months), myocardial infarction (within 6 months), stable or unstable angina, coronary artery bypass surgery (within 6 months), stroke (within 6 months), symptomatic carotid artery disease, or moderate to severe mitral or aortic stenosis, known moderate or severe hepatic impairment (Child-Pugh B and C) <br/ ><br>8.Systolic blood pressure of <90 mmHg or dizziness at time of enrollment <br/ ><br>9. Systemic use of immunosuppressive medication (including corticosteroids and glucocorticoids), use of rituximab within 6 months prior to enrollment, use of alpha-1 adrenergic receptor antagonists, combined alpha-1/beta- adrenergic receptor antagonists, sotalol, clonidine, phosphodiesterase type 5 inhibitors, nitrates, asenapine, alpha-methyldopa <br/ ><br>10.Allergy or intolerance to quinazolines (including doxazosin, prazosin, terazosin) | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Doxazosin mesylate: Doxazosin mesylate and standard of care<br><br>Doxazosin<br>Dose<br>Day 1 -1 mg<br>Day 2- 1 mg<br>Day 3 â?? 2 mg<br>Day 4 â?? 2 mg<br>Day 5 â?? 4 mg<br>Day 6- 4 mg<br>Day 7 â?? 4 mg<br>Day 8 â?? 6 mg<br>Day 9 â?? 6 mg<br>Day 10 â?? 6 mg<br>Day 11 â?? 8 mg<br>Day 12 â?? 8 mg<br>Day 13 â?? 8 mg<br>Day 14 â?? 8 mg<br><br>Frequency - once daily<br>Route of administration - Oral<br>Duration of therapy - 14 days<br><br><br>Control Intervention1: P Tabletten (Placebo): Placebo and standard of care<br>Placebo Dose<br>Day 1 â?? half tablet<br>Day 2- half tablet<br>Day 3 â?? one tablet<br>Day 4 â?? one tablet<br>Day 5 â?? Two tablets<br>Day 6- Two tablets<br>Day 7 â?? Two tablets<br>Day 8 â?? Three tablets<br>Day 9 â?? Three tablets<br>Day 10 â?? Three tablets<br>Day 11 â?? Four tablets<br>Day 12 â?? Four tablets<br>Day 13 â?? Four tablets<br>Day 14 â?? Four tablets<br><br>Frequency - once daily<br>Route of administration - Oral<br>Duration of therapy - 14 days<br><br> | Evaluate the efficacy of treatment with doxazosin (given for at least 2 doses) versus placebo to <br/ ><br>prevent deterioration of COVID-19 to Moderate/Severe disease in subjects testing positive for SARS-CoV-2 and presenting with Mild disease at the time of enrollment.Timepoint: After the treatment duration of 14 days | | | | Yes | False | | |
| +++ | CTRI/2021/09/036100 | 8 November 2021 | controlled trial of SHIRO KLOMAN treatment in mild to moderate symptomatic patients with SARS-CoV-2 Infection (Covid-19). | A multi-centre, randomized, open label, two arm, controlled trial of SHIRO KLOMAN given along with treatment of physicianâ??s choice versus treatment of Conventional Covid Protocol in mild to moderate symptomatic patients with SARS-CoV-2 Infection (Covid-19). - SHIRO KLOMAN | | Bindi Prashant Shah | 01-09-2021 | 20210901 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59711 | Not Recruiting | No | | | | 10-09-2021 | 120 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 3 | India | Dr Tapan Shah | | Sanad Janta Multispeciality Hospital. Ahmedabad Sanand | drtapansah@gmail.com | 09825739241 | Sanad Janta Multispeciality Hospital. | Inclusion criteria: Have positive reverse-transcriptase-polymerase chain reaction (RT-PCR) test for COVID-19 in a diagnostic specimen. <br/ ><br>Are either asymptomatic or have only mild symptoms (cough and/or fever and/or sore throat and/or other upper respiratory symptoms and/or malaise, headache, muscle pain) at the time of study inclusion. <br/ ><br>Have an oxygen saturation of >94% while breathing ambient air, if this is measured. <br/ ><br>Have either normal levels of haematological, liver and renal functions, and electrolytes OR no worse than Grade 1 (CTCAE Version 5.0) abnormalities in any of these parameters. High blood sugar or HbA1c of any degree will not be a criterion for exclusion. <br/ ><br> <br/ ><br>Sexually active women, unless surgically sterile (at least 6 months prior to study drug administration) or postmenopausal for at least 12 consecutive months, must use an effective method of avoiding pregnancy [including oral, transdermal, or implanted contraceptives (any hormonal method in conjunction with a secondary method), intrauterine device, female condom with spermicide, diaphragm with spermicide, absolute sexual abstinence, use of condom with spermicide by sexual partner or sterile (at least 6 months prior to study drug administration) sexual partner] during study and up to 30 days after the last dose of study drug. Cessation of birth control after this point should be discussed with a responsible physician. <br/ ><br> | Exclusion criteria: Have pneumonia confirmed by chest imaging. <br/ ><br>Patients receiving mechanical ventilation or ECMO or who have multiorgan failure. <br/ ><br>Pregnant or lactating females. <br/ ><br>Therapy with an investigational agent within the past 30 days from screening. <br/ ><br>Treatment with any agent with anti-SARS-CoV-2 activity prior to screening. <br/ ><br>Any other conditions, including moderate to severe illness, which would make the patient, in the opinion of the Investigator, unsuitable for the study. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J101- Influenza due to other identifiedinfluenza virus with other respiratory manifestations
| | To assess the efficacy of SHIRO KLOMAN in the management of mild to moderate COVID-19 casesTimepoint: Screening,Baseline,3rd Day, 8th day 15th day | | | | Yes | False | | |
| +++ | CTRI/2021/09/036101 | 8 November 2021 | Stress, its associated risk factors, and effect of slow-paced breathing in post COVID -19 subjects | Electrophysiological and biochemical correlates of stress, its associated risk factors, and effect of slow-paced breathing in post COVID -19 subjects: A Prospective Interventional Study | | Simran Kaur | 01-09-2021 | 20210901 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59595 | Not Recruiting | No | | | | 15-09-2021 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Investigator Blinded | N/A | India | Simran Kaur | | Room No. 2021
Department of Physiology
All India Institute of Medical Sciences, New Delhi | drsimrankaur@aiims.edu | 09810811594 | All India Institute of Medical Sciences, New Delhi | Inclusion criteria: 1)Post COVID-19 subjects with â?¥ 4 weeks of RT-PCR positivity <br/ ><br>2)Willing to participate | Exclusion criteria: 1) Subjects currently on respiratory support (home/ hospital based) <br/ ><br>2) Past or Present H/O neuropsychiatric or neurodegenerative disorder <br/ ><br>3) H/O uncontrolled hypertension, coronary artery disease, cerebrovascular accident <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Slow Paced Breathing: Definition: SPB is a breathing technique where the inhalation and exhalation durations are controlled (â??pacedâ??), and where breathing is performed at a slower pace (around 6 cycles per minute) than spontaneous breathing, which is usually between 12 and 20 cycles per minute in adults.<br>Protocol: The participants will be instructed to inhale continuously through the nose while the ball is going up, and exhale continuously with pursed lips when the ball is going down. The video includes a3 x 5 min SPB exercise with a 1-min break between each 5 min SPB unit, corresponding to a total of 17 min. The 1 min break between each SPB unit was introduced based on previous experience of participants reporting 15 minutes of non-stop SPB was very demanding. Exhalation (5.5 s) lasted slightly longer than inhalation (4.5 s) as prolonged exhalation contributes to larger beat-to-beat heart fluctuations compared to a prolonged inhalation, and therefore induces a higher CVA.<br>Recording: The electrophysiological markers will be assessed using EEG, ECG, GSR and biochemical markers of stress per protocol. The acquisition and analysis for the mentioned markers have already been standardized in the laboratory. <br><br> | the occurrence of stress and its predictors and quantitatively assess the physiological and biochemical changes due to stress, stress reactivity and mitigation (slow paced breathing)Timepoint: baseline, 3 months and 6 months | | | | Yes | False | | |
| +++ | CTRI/2021/09/036114 | 8 November 2021 | Effect of exercise on functional ability in persons who recovered from covid | Effect of Aerobic Exercise training on functional capacity in Post COVID individuals: A Randomised Controlled trial. | | Nitte deemed to be university | 01-09-2021 | 20210901 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59378 | Not Recruiting | No | | | | 10-09-2021 | 36 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | N/A | India | Dr Purusotham chippala | | Ground floor , Room no 20 Department of physiotherapy, K.S.
Hegde medical sciences complex, Nitte deemed to be university,
Deralakatte, Mangalore,india | Chippala1979@gmail.com | 09916460185 | Nitte institute of physiotherapy | Inclusion criteria: 1) The age ranges from 24 - 44 years <br/ ><br>2) Male and Female individuals <br/ ><br>3) Patient affected with COVID 19 virus <br/ ><br>4) Borg scale less than or equal to 6 | Exclusion criteria: 1) Mechanically ventilated patients <br/ ><br>2) Intensive care unit patients <br/ ><br>3) Uncooperative patient <br/ ><br>4) Patients with unstable vitals <br/ ><br>5) Any other organ dysfunction <br/ ><br>6) severe hypoxemia at rest or acute respiratory failure <br/ ><br>7) Individuals with <3 METs | | Intervention1: Aerobic exercise: Intervention Group-<br>The intervention group will be given aerobic training consisted of 30 minutes <br>training 3 sessions per 4 weeks. The exercise includes warm up, deep <br>breathing exercise, chest mobility exercise, brisk walking followed by cool <br>down.<br><br>Control group-<br>The control group will receive deep breathing exercise with the repetition of <br>10 times of three sets. In between each set 1 minute rest is allowed followed <br>by walking for 20 minutes given an interval of one minute in between half time<br>(10 minutes) this should be followed for 3 sessions per week for 4 weeks<br><br>Control Intervention1: Not applicable: Not applicable<br> | 6 minute walk testTimepoint: 4 weeks | | | | Yes | False | | |
| +++ | CTRI/2021/09/036115 | 8 November 2021 | A study to evaluate the effects of stem cells in patients with Acute Respiratory Distress Syndrome Caused by Pneumonia due to COVID-19 | A Label Extension, Single Arm, Multicentric, Two Dosage, Phase III Study Assessing the Efficacy and Safety of Intravenous Administration of stempeucel® (Adult Human Bone Marrow Derived, Cultured, Pooled, Allogeneic Mesenchymal Stromal Cells) in Patients with Moderate to Severe Acute Respiratory Distress Syndrome due to COVID-19 | | Stempeutics Research Pvt Ltd | 01-09-2021 | 20210901 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=46951 | Recruiting | No | | | | 06-09-2021 | 56 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 3 | India | Jijy Abraham | | Stempeutics Research
3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd.
#143, 212-215, EPIP Industrial Area | pawan.gupta@stempeutics.com | 08025028101 | Stempeutics Research | Inclusion criteria: 1. Males or females of age 18 to 65 years of Indian origin and diagnosed with COVID-19 by reverse transcription polymerase chain reaction (RT-PCR)/TrueNat/CBNAAT assay. <br/ ><br>2. Informed consent by the patient or his/her legal representative in case the patient is not capable of giving the consent. <br/ ><br>3. Patients diagnosed with COVID-19 causing moderate and severe ARDS as per the Berlin ARDS definition. <br/ ><br>a. Respiratory failure within one week of a known clinical insult or new and/or worsening respiratory symptoms <br/ ><br>b. Respiratory failure not fully explained by cardiac failure or fluid overload <br/ ><br>c. Moderate to severe hypoxemia must be present, defined as the ratio of PaO2/FiO2 with PEEP â?¥5 cmH2O or non-ventilated <br/ ><br>â?¢ Moderate ARDS: PaO2/FiO2 >100 mmHg and â?¤200 mmHg with PEEP â?¥5 cmH2O, or non-ventilated or Severe ARDS: PaO2/FiO2 â?¤100 mmHg with PEEP â?¥5 cmH2O, or non-ventilated <br/ ><br>d. Bilateral opacities <br/ ><br>4. Patients who can start receiving BMMSCs within 72 hours after the diagnosis of ARDS | Exclusion criteria: 1. Any other cause of ARDS not attributable to SARS-CoV2. <br/ ><br>2. Imminent and unavoidable progression to death within 24 hours, irrespective of the provision of treatments in the opinion of the investigator. <br/ ><br>3. Presence of any active malignancy. <br/ ><br>4. Any end stage organ disease as assessed by investigator which may possibly affects the safety of the study drug. <br/ ><br>5. Patient with history of any stem cell transplant in the past. <br/ ><br>6. Moderate to severe liver failure (Child â?? Pughâ??s score > 12). <br/ ><br>7. Patient with chronic respiratory disease or use of ventilator at home. <br/ ><br>8. Patients for whom 72 hours or longer has passed since the attachment of ventilator. <br/ ><br>9. Patient with pulmonary transplant or having history of lung lobectomy. <br/ ><br>10. Patient with clinically findings consistent with diffuse alveolar haemorrhage. <br/ ><br>11. Patients with mean arterial (blood) pressure < 60 mmHg despite treatment with one or more vasopressor or vasoactive agent. <br/ ><br>12. Patients who are appropriate to be treated with extracorporeal membrane oxygenation (ECMO) at screening or currently receiving ECMO. <br/ ><br>13. Patients who were resuscitated after cardio-respiratory arrest. <br/ ><br>14. Patients with uncontrolled co-morbidities like hypertension, diabetes mellitus etc., as per investigator discretion <br/ ><br>15. Patients who are under artificial dialysis at screening. <br/ ><br>16. Patient documented to have deep venous thrombosis or pulmonary embolism within last 3 months. <br/ ><br>17. Patients with a history of myocardial infarction within 6 months before screening. <br/ ><br>18. Women of childbearing age who are not using an adequate method of contraception. If the patient is menopausal, it must be documented. <br/ ><br>19. Pregnancy or breast feeding. <br/ ><br>20. Patient with HIV infection. <br/ ><br>21. Patient expected to have hypersensitivity <br/ ><br> | Health Condition 1: J80- Acute respiratory distress syndrome
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Stempeucel® (Ex - vivo cultured allogeneic Mesenchymal stromal cells): Dose of 200 million cells at Day 0 and Day 4 ± 1 day IV infusion ( total of two infusion)<br>Control Intervention1: Control Arm: Standard of Care<br>Control Intervention2: Not Applicable: Single Arm Study Not Applicable<br> | Percent mortality 28 days after administration of BMMSCsTimepoint: 28 days | | | | Yes | False | | |
| +++ | CTRI/2021/09/036116 | 8 November 2021 | The study of C21 in hospitalised subjects with COVID-19 infection not requiring mechanical ventilation | A randomized, double-blind, placebo-controlled, parallel group, phase 2/3, multicenter trial investigating the efficacy and safety of C21 as add on to standard of care in adult subjects with COVID-19. - ATTRACT Trial | | Vicore Pharma AB | 01-09-2021 | 20210901 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59194 | Not Recruiting | No | | | | 27-09-2021 | 600 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 2/ Phase 3 | Argentina;Brazil;Colombia;Czech Republic;India;Peru;Philippines;Poland;Russian Federation;Ukraine;United States of America | Mr Gajendrasinh Chanchu | | Clinical Operations QED Clinical Services India Private Limited, Office number B-209, Westgate Besides YMCA Club S. G. Highway | yraghuvanshi@orphan-reach.com | 9619579849 | Orphan Reach | Inclusion criteria: 1. Age �18 years or the legal age of consent in the jurisdiction in which the trial is taking place at the time of signing the informed consent. (Specific for India; Age �18 at the time of signing the informed consent to �65 years.) <br/ ><br>2. Hospitalized due to SARS-CoV-2 infection confirmed by polymerase chain reaction (PCR) test, documented by either of the following: <br/ ><br>a. PCR positive in sample collected <72 hours prior to randomization (Visit 2); OR <br/ ><br>b. PCR positive in sample collected �72 hours and �7 days prior to randomization, documented inability to obtain a repeat sample AND progressive disease suggestive of ongoing SARS-CoV-2 infection. <br/ ><br>3. A score of 5 or 6 on the 8-point ordinal scale: <br/ ><br>a. Score 5: Hospitalized, requiring supplemental oxygen. <br/ ><br>b. Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen device. <br/ ><br>4. Contraceptive use by men and women of childbearing potential consistent with local regulations regarding the methods of contraception for those participating in clinical studies. <br/ ><br>5. Written informed consent, consistent with International Council for Harmonization (ICH Good Clinical Practice (GCP) R2 and local laws, obtained before the initiation of any trial-related procedure. <br/ ><br>6. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. <br/ ><br>7. Specific for India: For subjects with an ordinal scale score of 5, moderate to severe COVID-19 disease confirmed by at an SpO2 � 93 % or a respiratory rate � 24/min on room air. Note: If a subject is on supplemental oxygen with SpO2 >93% and respiratory rate <24/min, but desaturation to � 93 % or increase of respiratory rate to � 24/min on lower supplemental oxygen or room air is documented during screening, the inclusion criterion is considered to be met. | Exclusion criteria: 1. Concurrent serious medical condition which in the opinion of the investigator constitutes a risk or a contraindication for the participation in the trial or that could interfere with the trial objectives, conduct or evaluation. <br/ ><br>2. Known, active tuberculosis, active hepatitis B, C, or human immunodeficiency virus (HIV) infection (i.e., HIV with a CD4 count <500 cells/mm³). <br/ ><br>3. Impaired hepatic function (i.e., Child-Pugh class B or C). <br/ ><br>4. Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) �30 ml/min/1.73 m2). <br/ ><br>5. COVID-19 symptom onset >14 days prior to screening (Visit 1). <br/ ><br>6. Hospitalized due to COVID-19 for >72 hours at screening (Visit 1). <br/ ><br>7. Invasive mechanical ventilation or ECMO within 72 hours of screening (Visit 1) <br/ ><br>8. Expected need for invasive mechanical ventilation or ECMO in <48 hours in the opinion of the investigator. <br/ ><br>9. Moderate to severe ARDS (e.g., same-day PaO2/FiO2 �200 mmHg; or SpO2/FiO2 �232 if arterial blood gas test is not available), if on non-invasive mechanical ventilation or high-flow oxygen. <br/ ><br>10. Pregnant or breast-feeding female subjects. <br/ ><br>11. Any previous and concurrent experimental treatment for COVID-19 that is not considered local SoC. <br/ ><br>12. Treatment with the medications listed below within 1 week prior to screening (Visit 1) or anticipated need for such medication during the participation in this trial: <br/ ><br>a. Strong Cytochrome P450 (CYP) 3A4 inducers. <br/ ><br>b. P-glycoprotein (P-gp) substrates with narrow therapeutic index. <br/ ><br>c. High dose BCRP sensitive substrates. <br/ ><br>d. Warfarin. <br/ ><br>e. Sulphasalazine or rosuvastatin. <br/ ><br>13. Current or previous participation in any other clinical trial where the subject has received a dose of IMP within 1 month or 5 half-lives of the IMP, whichever is longest, prior to screening (Visit 1). <br/ ><br>14. Positive pregnancy test <br/ ><br>15. Abnormal laboratory value at screening (Visit 1) indicating a potential risk for the subject if enrolled in the trial as evaluated by the investigator. | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: C21: IMP will be administered twice daily orally for 14 days from Visit 2 to Visit 15 as follows: 1. Morning dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hours fasting 2 Afternoon/evening dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hours fasting Subjects will be required not to eat anything for 1 hour after taking the IMP.<br>Control Intervention1: Placebo: IMP will be administered twice daily orally for 14 days from Visit 2 to Visit 15 as follows: 1. Morning dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hours fasting 2 Afternoon/evening dose: Two 50 mg capsules to be taken with a glass of water after minimum 2 hours fasting Subjects will be required not to eat anything for 1 hour after taking the IMP.<br> | Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15.Timepoint: Proportion of subjects discharged from hospital and free of supplemental oxygen at Day 15. | | | | Yes | False | | |
| +++ | CTRI/2021/09/036117 | 8 November 2021 | Evaluating Covid 19 lock down effect on health of college students | Evaluating Covid 19 lockdown effect on biopsychosocial health of college students- A pilot study | | Amar Jyoti Institute Of Physiotherapy | 01-09-2021 | 20210901 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59429 | Not Recruiting | No | | | | 30-09-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Amit Prashar | | 2nd floor, Physiotherapy department, Amar Jyoti Institute of
Physiotherapy Karkardooma, Vikas marg, New Delhi
East
Delhi
110092
India | jeyanthi.s@ajipt.org | 9958158815 | Amar Jyoti Institute Of Physiotherapy | Inclusion criteria: 1.Willing participants. <br/ ><br>2.Both genders. <br/ ><br>3.College students. <br/ ><br>4.Attending online classes through devices(laptop,computer,mobile,etc) | Exclusion criteria: 1.History of any recent musculoskeletal injuries. <br/ ><br>2.History of any recent systemic disease. <br/ ><br>3.History of congenital/neurological/cardiorespiratory problem. <br/ ><br>4.Unwilling participants. <br/ ><br> | | Intervention1: NIL: NIL<br>Control Intervention1: NIL: NIL<br> | Physical fitness test batteries <br/ ><br>Timepoint: One time <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/09/036162 | 8 November 2021 | A Study to Evaluate Efficacy and Safety of a Combination of Homeopathic Medications as an Add on Therapy in Patients with Severe to Critical COVID-19 Infection | A Randomized, Open label Study to Evaluate Efficacy and Safety of a Combination of Homeopathic Medications as an Add on Therapy to Standard of Care in Patients with Severe to Critical SAR-COV-2 (COVID-19) Infection | | Dr Manoj Kuriakose | 02-09-2021 | 20210902 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59978 | Not Recruiting | No | | | | 01-10-2021 | 30 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 2 | India | Dr Ashish Kumar Dixit | | Department of AYUSH, All India Institute of Medical Sciences Bhopal | abhishek.genmed@aiimsbhopal.edu.in | | All India Institute of Medical Sciences Bhopal | Inclusion criteria: 1. Subject (or legally authorized representative) provides informed consent prior to initiation of any study procedures. <br/ ><br>2. Male and female subjects greater than 18 years of age. <br/ ><br>3. Has laboratory-confirmed SARS-CoV-2 infection as determined by RT-PCR, Rapid Antigen Test, CBNAAT or CT suggestive of Pneumonia (CO-RADS 5 grade). <br/ ><br>4. Adult with radiological signs of pneumonia (chest x-ray, CT scan, etc.) plus one of the following. <br/ ><br>a. respiratory rate >30 breaths/min, <br/ ><br>b. severe respiratory distress, <br/ ><br>c. SpO2 <90% on room air. <br/ ><br>d. With/without Oxygenation impairment: (Mild ARDS: 200 mmHg < PaO2/FiO2 â?¤ 300 mmHg (with PEEP or CPAP â?¥5 cm H2O); Moderate ARDS: 100 mmHg < PaO2/FiO2 â?¤200 mmHg with PEEP â?¥5 cm H2O); Severe ARDS: PaO2/FiO2 â?¤ 100 mmHg with PEEP â?¥5 cm H2O) <br/ ><br>5. Patient with or without pre-existing significant co-morbidities (e.g. lung diseases, diabetes, hypertension) at the discretion of the investigator. <br/ ><br>6. Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use contraceptive methods. <br/ ><br>7. Willingness and ability to comply with trial and follow-up procedures. <br/ ><br>8. Ability to understand the nature of the trial and give written informed consent. <br/ ><br> | Exclusion criteria: 1. Patient with mild-moderate COVID-19 infection <br/ ><br>2. Patients who are allergic to arsenic album products <br/ ><br>3. Severely immunocompromised patients for example patients with a history of HIV infection, patients with solid organ transplantation or bone marrow transplantation, patients receiving chemotherapy/radiotherapy, patients with primary immunodeficiency. <br/ ><br>4. ALT/AST > 5 times the upper limit of normal. <br/ ><br>5. Stage 4 severe chronic kidney disease or requiring dialysis (eGFR <30 ml/min) <br/ ><br>6. Subjects who is receiving Covid-19 directed alternative medication (e.g. Any ayurvedic, Unani or homeopathic) <br/ ><br>7. Participation of patient in other investigational clinical studies <br/ ><br>8. Pregnant or breastfeeding. <br/ ><br>9. Concomitant disease or condition that could interfere with the conduct of the study, or for which the treatment could interfere with the conduct of the study, or that would in the opinion of investigator, pose an unacceptable risk to the subject in this study. <br/ ><br>10. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol. <br/ ><br>11. Psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Combination of homeopathic medication: Combination of homeopathic medication (Arsenicum Album +Bryonia Alba + Phosphorus)<br>Control Intervention1: Standard of Care (SOC): The Standard of Care (SOC) will be given as per the recent guidelines for management of COVID 19 infection and may include <br>- Symptomatic treatment <br>- Oxygenation <br>- Conservative fluid management.<br>- Corticosteroids: IV Methylprednisolone 1-2 mg/kg or Dexamethasone 0.2-0.4 mg/kg for 5-7 days<br>- Anti-IL-6 therapy such as tocilizumab<br><br> | â?? Patient clinical status (8-point ordinal scale) at Day 15. <br/ ><br>1. Death <br/ ><br>2. Hospitalized, on invasive mechanical ventilation or ECMO <br/ ><br>3. Hospitalized, on non-invasive ventilation or high flow oxygen devices <br/ ><br>4. Hospitalized, requiring supplemental oxygen <br/ ><br>5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID-19 related or otherwise) <br/ ><br>6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. <br/ ><br>7. Not hospitalized, limitation on activities and/or requiring home oxygen <br/ ><br>8. Not hospitalized, no limitations on activities <br/ ><br>Timepoint: at day 15 | | | | Yes | False | | |
| +++ | CTRI/2021/09/036211 | 8 November 2021 | Management of anaesthesia for patients undergoing mucormycosis surgery | Anaesthetic management of patients coming for mucormycosis surgery: A prospective observational study | | Supreeth R Shetty | 03-09-2021 | 20210903 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60110 | Not Recruiting | No | | | | 10-09-2021 | 40 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Supreeth R Shetty | | Department of Anaesthesiaia,
SDM College of Medical Sciences and Hospital,
Sattur, Dharwad.
| supreethrshetty@gmail.com | 9945619565 | SDM College of Medical Sciences and Hospital | Inclusion criteria: 1. Patients requiring anaesthesia for debridement of rhinocerebral mucormycosis. <br/ ><br>2. Patients willing to participate. <br/ ><br> | Exclusion criteria: 1.Patient refusal | Health Condition 1: U072- COVID 19 virus not identified
| | TO assess mortality and morbidity like need for ICU stay, mechanical ventilation after surgeryTimepoint: 0 hours after extubation <br/ ><br>24 hours after end of surgery | | | | Yes | False | | |
| +++ | CTRI/2021/09/036213 | 8 November 2021 | Effect of ventilatory changes in patients recovering from recent COVID infections, who are receiving General Anaesthesia. | Airway and ventilatory changes during general anaesthesia in patients recovering from
COVID infection: Prospective observational study | | Sameer Desai | 03-09-2021 | 20210903 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60112 | Not Recruiting | No | | | | 10-09-2021 | 40 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Sameer N Desai | | Department of Anaesthesia
SDM College of Medical Sciences and Hospital
Sattur
Dharwad
India 15, Chanakyapuri | sameerdesai78@gmail.com | 9480752566 | SDMCMS &H | Inclusion criteria: Patients who had confirmed COVID infection within 60 days presenting for general anaesthesia | Exclusion criteria: 1. Patient having active COVID infection( less than 10 days) <br/ ><br>2. Patients presenting more than 60 days after infection <br/ ><br>3. Patient refusal | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: ventilatory parameters and pulmonary complications during general anaesthesia: VENTILATION parameters: Mode, Tidal volume, PEEP, Fio2 used Peak airway pressure, Plateau pressure, Lung Compliance will be noted <br>Episodes of desaturation â?? measures taken-<br>Laryngospasm/bronchospasm during extubation will be noted<br>Intervention2: NIL: observational trial<br>Control Intervention1: NIL: Observational study<br> | Lung compliance during surgeryTimepoint: Immediate after intubation, 15,60, 120 minutes during surgery | | | | Yes | False | | |
| +++ | CTRI/2021/09/036224 | 8 November 2021 | HRCT Chest findings post COVID recovery | CT Thorax dynamics in follow-up patients with COVID 19 Pneumonia | | Dept of Critical Care Medicine | 03-09-2021 | 20210903 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60119 | Not Recruiting | No | | | | 15-09-2021 | 80 | Observational | Single Arm Trial<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India | samir samal | | Department of Critical Care Medicine
MICU 1st Floor
IMS and SUM Hospital
K 8 Kalinga Nagar
Bhubaneswar | samirsamal@soa.ac.in | 8108474527 | IMS and SUM Hospital | Inclusion criteria: All patients who had suffered from COVID 19 pneumonia and have documented evidence | Exclusion criteria: Follow up within 28 days of COVID 19 pneumonia | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | Evaluate Fibrosis ScoreTimepoint: Baseline <br/ ><br>9 months | | | | Yes | False | | |
| +++ | CTRI/2021/09/036225 | 8 November 2021 | Clinical Utility of Thromboelastography to predict complications in Covid-19 | Clinical Utility of Thromboelastography to predict complications in Covid-19 patients | | Prithvishree Ravindra | 03-09-2021 | 20210903 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60208 | Not Recruiting | No | | | | 15-09-2021 | 147 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Prithvishree Ravindra | | Dept of Emergency Medicine, Kasturba Medical college, Manipal | prithvishree@gmail.com | | Kasturba Medical College, Manipal | Inclusion criteria: Patients diagnosed with COVID-19, presenting to Emergency Department | Exclusion criteria: Patients who have known bleeding disorders <br/ ><br>Patients who do not consent | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: nil: nil<br> | A. To document the Thromboelastography (TEG) findings of COVID19 patients <br/ ><br>B.To explore the utility of TEG to predict coagulopathy of COVID19 patients <br/ ><br>C. To predict mortality and morbidity of patients using TEG in COVID-19 patients <br/ ><br>Timepoint: Baseline <br/ ><br>Discharge <br/ ><br>1 month | | | | Yes | False | | |
| +++ | CTRI/2021/09/036255 | 8 November 2021 | Comparison between high flow nasal cannula versus pressure support ventilation in covid positive patients | A randomized observational study to compare high flow nasal cannula versus pressure support ventilation in covid positive patients with CT score 15 or less than 15 | | SMS Medical college Jaipur | 06-09-2021 | 20210906 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60116 | Not Recruiting | No | | | | 20-09-2021 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable | N/A | India | Dr Jahnu Bhoj Nagal | | Department of anaesthesia, SMS medical college and attached hospitals, Jaipur rajasthan 302004 | priyasingh.pgr@gmail.com | | SMS medical college Jaipur | Inclusion criteria: body weight of 45 to 80 kg <br/ ><br>RT PCR covid positive patients <br/ ><br>CT score 15 or less than 15 <br/ ><br>historty of HTN/ DM /CAD | Exclusion criteria: CT score more than 15 <br/ ><br>age more than 60 years | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Mode of oxygen therapy <br>High flow nasal cannula versus pressure support venyilation: We will compare mode of oxygen therapy in covid positive patients of CT score 15 or less than 15 .<br>We will use high flow nasal cannula in 30 patients and in another 30 patients we will use pressure support ventilation.<br>Both modes are life saving , we want to observe which mode gives early recovery.<br>Duration - we will follow up patients 4 weeks from the day of admission.<br> | WEAN OFF FROM OXYGEN SUPPORT <br/ ><br>Timepoint: Zero time at the time of admission <br/ ><br>1week <br/ ><br>2weeks <br/ ><br>3 weeks <br/ ><br>4 weeks <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/09/036256 | 8 November 2021 | A study to perceive the mindset of the community and orthodontists on treatments needs during COVID-19 pandemic. | Impact of COVID-19 Pandemic on the perception of Orthodontic treatment needs in the community. | | DR CIBIVISHNU ELAVARASU | 06-09-2021 | 20210906 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60058 | Not Recruiting | No | | | | 01-10-2021 | 385 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | N/A | India | DR SUNIL MUDDAIAH | | Room No: 06, Department Of Orthodontics, Coorg Institute Of Dental Sciences, Kk Campus, Maggula, Virajpet, Kodagu Karnataka - 571218
India | drsunilmuddaiah@gmail.com | 9448113013 | Coorg Institute Of Dental Sciences | Inclusion criteria: 1)Individuals undergoing orthodontic treatment of any form (fixed/removable appliances), whose treatment started before the implemented lockdown. <br/ ><br>2)Individuals who are interested in orthodontic treatment. <br/ ><br>3)Orthodontists practicing in clinics. <br/ ><br> | Exclusion criteria: Individuals who are not interested. | Health Condition 1: K089- Disorder of teeth and supporting structures, unspecified
| Intervention1: NIL: NIL<br> | Patients prefer orthodontic treatmentTimepoint: End of Trial | | | | Yes | False | | |
| +++ | CTRI/2021/09/036257 | 8 November 2021 | Intranasal COVID-19 vaccine Phase 2 study in Healthy volunteers | A Phase 2, Randomized, Double Blind, Multicenter Study to Evaluate the Immunogenicity,
Reactogenicity and Safety of an Intranasal Adenoviral vector COVID-19 vaccine (BBV154) in Healthy Volunteers. - BBV154 INTRANASAL PHASE 2 STUDY | | Bharat Biotech International Ltd | 06-09-2021 | 20210906 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59902 | Not Recruiting | No | | | | 13-09-2023 | 200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | Phase 2 | India | Dr Krishna Mohan | | S block, Medical Affairs Department, Bharat Biotech International Ltd.,Genome Valley,Shameerpet | kmohan@bharatbiotech.com | | Bharat Biotech International limited | Inclusion criteria: Inclusion <br/ ><br>1. Ability to provide written informed consent <br/ ><br>2. Participants of either gender of age between â?¥18 to â?¤60 years. <br/ ><br>3. Good general health as determined by the discretion of investigator (vital signs (heart rate <br/ ><br>â?¥60 toâ?¤100 bpm; blood pressure systolic â?¥90 mm Hg and <140 mm Hg; diastolic â?¥ 60 mm <br/ ><br>Hg and <90 mm Hg; oral temperature <100.4ºF), medical history, and physical <br/ ><br>examination). <br/ ><br>4. Expressed interest and availability to fulfil the study requirements. <br/ ><br>5. For a female participant of child-bearing potential, planning to avoid becoming pregnant <br/ ><br>(use of an effective method of contraception or abstinence) from the time of study <br/ ><br>enrolment until at least four weeks after the last vaccination <br/ ><br>6. Male subjects of reproductive potential: Use of condoms to ensure effective contraception <br/ ><br>with the female partner from first vaccination until 3 months after last vaccination. <br/ ><br>7. Male subjects agree to refrain from sperm donation from the time of first vaccination until 3 <br/ ><br>months after last vaccination <br/ ><br>8. Participants must refrain from blood or plasma donation from the time of first vaccination <br/ ><br>until 3 months after last vaccination <br/ ><br>9. Agrees not to participate in another clinical trial at any time during the study period. <br/ ><br>10. Agrees to remain in the study area for the entire duration of the study. <br/ ><br>11. Willing to allow storage and future use of biological samples for future research | Exclusion criteria: Exclusion <br/ ><br>1. History of any other COVID-19 investigational/or licensed vaccination. <br/ ><br>2. Unacceptable laboratory abnormality at screening (prior to first vaccination) or safety <br/ ><br>testing, as listed below <br/ ><br>3. Confirmed SARS-CoV-2 at the time of screening using RT-PCR and ELISA method. <br/ ><br>4. Any history of facial nerve paralysis <br/ ><br>5. History of cold, sneezing, nasal obstruction in the past 3 days. <br/ ><br>6. Prescribed usage of any nasal spray/or nasal drop medication. <br/ ><br>7. Any significant abnormality altering the anatomy of the nose in a substantial way or <br/ ><br>nasopharynx that may interfere with the aims of the study and in particular any of the nasal <br/ ><br>assessments or viral challenge (historical nasal polyps can be included, but large nasal <br/ ><br>polyps causing current and significant symptoms and/or requiring regular treatments in the <br/ ><br>last month are excluded) <br/ ><br>8. For women of child bearing potential, a positive serum pregnancy test (during screening <br/ ><br>within 45 days of enrolment) or positive urine pregnancy test (within 24 hours of <br/ ><br>administering each dose of vaccine). <br/ ><br>9. Temperature >38.0°C (100.4°F) or symptoms of an acute self-limited illness such as an <br/ ><br>upper respiratory infection or gastroenteritis within three days prior to each dose of vaccine. <br/ ><br>10. Medical problems as a result of alcohol or illicit drug use during the past 12 months. <br/ ><br>11. Receipt of an experimental agent (vaccine, drug, device, etc.) within 60 days before <br/ ><br>enrolment or expects to receive an investigational agent during the study period. <br/ ><br>12. Receipt of any licensed vaccine within four weeks before enrolment in this study. <br/ ><br>13. Known sensitivity to any ingredient of the study vaccines, or a more severe allergic reaction <br/ ><br>and history of allergies in the past. <br/ ><br>14. Receipt of immunoglobulin or other blood products within the three months prior to <br/ ><br>vaccination in this study. <br/ ><br>15. Immunosuppression as a result of an underlying illness or treatment with <br/ ><br>immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation <br/ ><br>therapy within the preceding 36 months. <br/ ><br>16. Long-term use ( > 2 weeks) of oral or parenteral steroids (glucocorticoids) or high-dose <br/ ><br>inhaled steroids ( >800 mcg/day of beclomethasone dipropionate or equivalent) within the <br/ ><br>preceding six months (nasal and topical steroids are allowed). <br/ ><br>17. Any history of hereditary angioedema or idiopathic angioedema. <br/ ><br>18. Any history of anaphylaxis in relation to vaccination. <br/ ><br>19. Any history of albumin-intolerance. <br/ ><br>20. Pregnancy, lactation, or willingness/intention to become pregnant during the study. <br/ ><br>21. History of any cancer. <br/ ><br>22. History of severe psychiatric severe conditions likely to affect participation in the study. <br/ ><br>23. A bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder, or prior <br/ ><br>history of significant bleeding or bruising following IM injections or venepuncture. <br/ ><br>24. Any other serious chronic illness requiring hospital specialist supervision. <br/ ><br>25. Chronic respiratory diseases like severe acute respiratory syndrome (SARS), including mild <br/ ><br>asthma. <br/ ><br>26. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, <br/ ><br>endocrine disorder, and neurological illness <br/ ><br>27. Morbidly obese (BMIâ? | | Intervention1: BBV154 INTRANASAL VACCINE<br><br>: Chimpanzee adenovirus 36 encoding SARS-CoV-2<br>pre-fusion stabilized spike protein (ChAd36-SARSCoV-<br>2-S) administered 0.5 mL of vaccine (BBV154) on day 0 and day 28 via intranasal route with a<br>dropper.<br>Control Intervention1: Placebo<br>: Placebo will be administered 0.5mL in two doses, on Day 0 and Day 28 through intranasal route.<br> | GMT of neutralizing antibodies (NAbâ??s) by MNT/PRNT assays across the two groups.Timepoint: days 0, 28, 42, 90 and 180 | | | | Yes | False | | |
| +++ | CTRI/2021/09/036258 | 8 November 2021 | Long-term Immunity after COVID vaccination in healthy adults | Study on Long-term Immunogenicity of COVID-19 vaccines in vaccine-naïve seronegative and seropositive participants - VISION 101 | | National Centre for Biological Sciences | 06-09-2021 | 20210906 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59809 | Recruiting | No | | | | 16-09-2024 | 800 | Interventional | Non-randomized, Multiple Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 4 | India | Dr Mangaiarkarasi Asokan | | National Centre for Biological Sciences
Tata Institute of Fundamental Research,
SLC Building, First Floor
Bellary Road, Bangalore National Centre for Biological Sciences
Tata Institute of Fundamental Research,
SLC Building, First Floor
Bellary Road, Banga | anand.kawade@kemhrcvadu.org | 9552588996 | KEM Hospital Research Centre | Inclusion criteria: 1. Between the ages of 18 and 45, both inclusive <br/ ><br>2. Permanent residents of the selected localities where community outreach is routine <br/ ><br>3. Only one member from a household will be selected. <br/ ><br>4. Either a) sero-negativity or b) sero-positivity to SARS-CoV-2 with or without a history of clinical illness suggestive of COVID-19 or confirmed COVID-19 in the past (either mild or moderate infection) <br/ ><br> | Exclusion criteria: 1. Participant failure to consent. <br/ ><br>2. Acute febrile illness in the participant at the time of the recruitment. <br/ ><br>3. Active cancers or bleeding disorders <br/ ><br>4. Individuals with a history of severe COVID-19 that required ventilation or received either convalescent plasma or monoclonal antibody treatments. <br/ ><br>5. Any medical condition in the participant, which, in the judgment of the investigator, would interfere with protocol adherence. <br/ ><br> | | Intervention1: COVISHIELD and COVAXIN in Seropositive and Seronegative individuals: COVISHIELD and COVAXIN will be administered to participants as per their choice under COVID National Immunisation Program<br>Intervention2: COVISHIELD & COVAXIN groups in seronegative participants: COVISHIELD & COVAXIN groups with seronegative status of participants at the time of recruitment<br>Control Intervention1: COVISHIELD & COVAXIN groups in seropositive participants: COVISHIELD & COVAXIN groups with seropositive status of participants at the time of recruitment<br> | Objective 1: To determine effect of the COVID-19 vaccination on humoral immune responses over a period of nine months in individuals seropositive as well as seronegative for SARS-CoV-2 infection <br/ ><br>Outcome: <br/ ><br>a. Difference in titers of plasma neutralizing antibody/glycoprotein-specific antibodies post vaccination between individuals seropositive and seronegative at baseline <br/ ><br>b. Difference in titers of binding antibody titers (RBD/spike, nucleocapsid) post vaccination in individuals seropositive and seronegative at baseline <br/ ><br>c. Seroconversion rate and duration of antibodies in individuals sero-negative at baseline <br/ ><br>d. Difference in magnitude of saliva antibody responses post vaccination between individuals seropositive and seronegative at baseline <br/ ><br>Timepoint: COVISHIELD-Day 0, 28, 84 & 98 and Month 6 & 9 <br/ ><br>COVAXIN-Day 0, 28, 42, 84 and Month 6 & 9 | | | | Yes | False | | |
| +++ | CTRI/2021/09/036269 | 8 November 2021 | Mortality predictors of Covid 19 | A retrospective analytical study to find out significant predictive factors of outcome in COVID-19 patients in second pandemic wave in a tertiary care hospital - None | | Sawai Man Singh Hospital | 06-09-2021 | 20210906 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59020 | Not Recruiting | No | | | | 15-09-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Reema Meena | | Reema Meena,
C/o Dr Shriphal Meena,
HOD Chamber, Anaesthesia
Department of Anaesthesia,
First Floor, Dhanwantri OT complex,
Sawai Man Singh Medical College,
Jaipur- 302004 Department of Anaesthesia,
Sawai Man Singh Medical College,
Jaipur- 302004 | reemadrrn@gmail.com | 01412518680 | Sawai Man Singh Medical College, Jaipur | Inclusion criteria: RTPCR positive Covid Patients admitted in the ICU <br/ ><br> | Exclusion criteria: Pregnant/Lactating females <br/ ><br>Suboptimal HRCT/Investigations | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | Survival/MortalityTimepoint: 30 days mortality | | | | Yes | False | | |
| +++ | CTRI/2021/09/036317 | 8 November 2021 | A clinical study to estimate the efficacy and safety of oral RP7214 in patients with Mild COVID-19 infection. | A Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of oral RP7214, a DHODH inhibitor, in Patients with Symptomatic Mild SARS-CoV-2 Infection. | | Incozen Therapeutics Pvt Ltd | 07-09-2021 | 20210907 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60260 | Recruiting | No | | | | 13-09-2021 | 204 | Interventional | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 2 | India | Dr Prajak Barde | | Clinical Research and Development,
Incozen Therapeutics Pvt Ltd
450, MN Science and Technology Park,
Genome Valley, Turkapally, Shameerpet Mandal
Hyderabad
| jayashri.krishnan@jssresearch.com | 919771407484 | JSS Medical Research Asia Pacific Private Limited | Inclusion criteria: 1.Willing and able to provide informed consent. <br/ ><br> <br/ ><br>2.Males and females of â?¥ 18 years of age, at the time of signing the informed consent. <br/ ><br> <br/ ><br>3.Patient with mild COVID-19 infection having â?¥ 1 symptoms. Mild infection is defined as presence of any one of the signs and symptoms of COVID-19 such as fever, cough, sore throat, malaise, headache, muscle pain, nausea, vomiting, diarrhea, loss of taste and/or smell, without shortness of breath or hypoxia. The respiratory rate should be < 24/min and SpO2 â?¥ 94% on room air. Patients should have one or more of these symptoms on the day of start of treatment. <br/ ><br> <br/ ><br>4.Laboratory confirmed Covid-19 infection by Reverse Transcription Polymerase Chain Reaction (RT-PCR) in nasopharyngeal sample (within 72 hours prior to randomization). <br/ ><br> <br/ ><br>5. Patient should have at least one pre-existing high-risk feature (e.g., age > 60 years, hypertension, diabetes mellitus, chronic lung disease, chronic kidney disease, liver disease, cerebrovascular disease, obesity (Body mass index (BMI) > 30.0 kg/m2), cancer) for developing severe Covid-19 illness. <br/ ><br> <br/ ><br>6. Ability to swallow and retain oral medication. <br/ ><br> <br/ ><br>7. Male patient who is surgically sterile, or who is willing to agree to remain completely abstinent or will agree to use barrier contraceptive measures and agrees to refrain from donating sperm during the entire study treatment period and for 3 months after the last dose of study drug. <br/ ><br> <br/ ><br>8. Women of childbearing potential who should be willing to use a medically acceptable method of contraception as defined in Appendix B while participating in the study and for 30 days after the last dose of study drug AND must have a negative pregnancy test within 3 days prior to dosing on Day 1. <br/ ><br> <br/ ><br>9. Willing to receive telephone calls or have videoconferences with study <br/ ><br>team personnel. <br/ ><br> <br/ ><br>10. Willing and able to understand the nature of this study, comply with the study procedures and follow-up procedures as per the study protocol. <br/ ><br> | Exclusion criteria: Individuals who meet any of the following criteria will be considered ineligible to participate in the study <br/ ><br> <br/ ><br>1.Patient with asymptomatic Covid-19 infection. <br/ ><br> <br/ ><br>2.Patient who has experienced onset of any of Covid-19 symptoms > 5 days at the time of randomization. <br/ ><br> <br/ ><br>3.Moderate to Severe COVID-19 infection. <br/ ><br> <br/ ><br>â?? Moderate infection is defined as patients with pneumonia with no signs of severe disease. Clinical features suggestive of presence of dyspnea and/or hypoxia, fever, cough, including SpO2 â?¤ 93% (range 90-93%) on room air OR respiratory rate â?¥ 24 per minute. <br/ ><br> <br/ ><br>â?? Severe infection is defined as patients with either severe pneumonia, acute respiratory distress syndrome, sepsis or septic shock. Clinical features suggestive of clinical signs of pneumonia plus one of the following parameters such as respiratory rate > 30 breaths/min, severe respiratory distress and SpO2 < 90% on room air; or signs of acute respiratory distress syndrome or sepsis or septic shock. <br/ ><br> <br/ ><br>4.Patient with Covid-19 re-infection <br/ ><br> <br/ ><br>5.Subjects who are severely immunocompromised (e.g., subjects with HIV infection, subjects with solid organ transplantation or bone marrow transplantation, subjects receiving chemotherapy/ radiotherapy, subjects with primary immunodeficiency). <br/ ><br> <br/ ><br>6.Autoimmune diseases such as multiple sclerosis (MS), systemic lupus <br/ ><br>erythematosus (SLE), rheumatoid arthritis (RA). <br/ ><br> <br/ ><br>7. Patients with any bleeding disorder e.g., hemophilia and von Willebrand <br/ ><br>disease. <br/ ><br> <br/ ><br>8. Current use of other DHODH inhibitors including teriflunomide or <br/ ><br>leflunomide. <br/ ><br> <br/ ><br>9. Patients who are on or immediately require Covid-19 directed treatment such as antivirals at the time of screening. <br/ ><br> <br/ ><br>10. Patients who have had received one or two doses of vaccine for Covid-19. <br/ ><br> <br/ ><br>11. Patients participating in another clinical study or use of any investigational product within 4 weeks or 5 half-lives of the drug, whichever is longer, before the date of dosing. <br/ ><br> <br/ ><br>12. Patient with history of heart failure, Class 2 or greater using the New York Heart Association (NYHA) functional class. <br/ ><br> <br/ ><br>13. Patients on medication that is associated with prolonged QT such as antipsychotic medications or antidepressants (e.g., citalopram, venlafaxine, and bupropion) and unable to stop the same during the trial. <br/ ><br> <br/ ><br>14. Pregnant or lactating females. <br/ ><br> <br/ ><br>15. Any physical examination findings and/or history of any illness that, in the opinion of the study investigator, might confound the results of the study or pose an additional risk to the patient. <br/ ><br> <br/ ><br>16. Inability or unwillingness to comply with study and/or follow-up procedures outlined in the protocol. <br/ ><br> <br/ ><br>17. Concurrent condition that in the investigatorâ??s opinion would jeopardize compliance with the protocol. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: RP7214: RP7214 tablets 400 mg will be self-administered orally twice a day for 14 days plus standard of care<br>Control Intervention1: Placebo: Matching placebo will be self-administered orally twice a day for 14 days plus standard of care<br> | Proportion of patients requiring Covid-19 related hospitalization by Day 15Timepoint: 15 Days | | | | Yes | False | | |
| +++ | CTRI/2021/09/036318 | 8 November 2021 | A Clinical Study of Nasya and Rasayan in Post COVID-19 Syndrome | A Clinical Study of Nasya and Rasayan in Post COVID-19 Syndrome Specifically on its Symptoms and Functional Status Scale | | Government Ayurved College and HospitalNagpur | 07-09-2021 | 20210907 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59320 | Not Recruiting | No | | | | 16-09-2021 | 24 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Other Blinding and masking:Not Applicable | Phase 2 | India | Ashish Thatere | | Kayachikitsa Department, 2 nd Floor, Government Ayurved College and Hospital, Sakkardara Square, Nagpur | ashish.thatere@gmail.com | 9423406821 | Government Ayurved College, Nagpur | Inclusion criteria: 1.Patient willing and able to participate in the study. <br/ ><br>2.COVID-19 positive patients after 21 days up to one year from the date of positive report. <br/ ><br>3.Patients presenting with minimum 20% (at least 4) symptoms of Post COVID 19 Syndrome. <br/ ><br>4.Functional Status Scale grading between 1 to 4 will be taken <br/ ><br>5.Patients who are suitable for Nasya. <br/ ><br>6.Patients who had not participated in any research projects since last 6 months. <br/ ><br>7.Patients irrespective of sex, socio-economical status and religion aged between 18-70 years. <br/ ><br>8.Patients of Post COVID 19 Syndrome having controlled hypertension <br/ ><br>9.(BP <_160/90 mm of hg) diabetes mellitus (HbA1c < 7) or any other Chronic systemic disease. <br/ ><br>10.Patients who follows instructions advised by researcher strictly. <br/ ><br> | Exclusion criteria: 1)Patient not willing for trial. <br/ ><br>2)Patient having severe disease with complication like AIDS, Cardiovascular disease, Pulmonary disease, Tuberculosis, malignancy will be rejected <br/ ><br>3)Patients having gross disability in performing daily normal routine i.e. bed ridden patients or confined to a wheelchair. <br/ ><br>4)Patients with poorly controlled Hypertension and Diabetes Mellitus <br/ ><br>5)Patients who are currently participating in any other clinical trials (since last 6 months). <br/ ><br>6)Patients contraindicated for Nasyaas mentioned in classics.[18] <br/ ><br>7)Patient who do not follow instruction strictly. <br/ ><br>8)Pregnant females and lactating mothers. <br/ ><br> <br/ ><br> <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: B342- Coronavirus infection, unspecified
| | 1.To study the effect of Bhargyadi Tail Nasya followed by Ashwagandha Kshirpaak and Guduchi Ghana Vati in Post COVID-19 Syndrome on itssymptoms. <br/ ><br>2.To study the effect of Bhargyadi Tail Nasya followed by Ashwagandha Kshirpaak and Guduchi Ghana Vati in Post COVID-19 Syndrome on Functional Status Scale . <br/ ><br>Timepoint: 33 days | | | | Yes | False | | |
| +++ | CTRI/2021/09/036348 | 8 November 2021 | SARS-CoV-2 infection in neurocritical care patients during the first and second peak | Clinical and epidemiological profile of the SARS-CoV-2 patients during the first and second peak-an audit in a tertiary neurocritical care unit in India | | None | 08-09-2021 | 20210908 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60287 | Not Recruiting | No | | | | 20-09-2021 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Suparna Bharadwaj | | Department of Neuroanesthesia and Neurocritical care, Faculty Block, National Institute of Mental Health and Neurosciences
Bengaluru 236, 10th cross, Maruthinagar, Yelahanka, Bangalore 560064 | acharya.suparna@gmail.com | 9483458514 | National Institute of Mental Health and Neurosciences | Inclusion criteria: Patients more than 18 years with neurological illness and positive for SARS CoV 2 infection | Exclusion criteria: Patients less than 18 years and also those who do not have SARS CoV-2 infection | Health Condition 1: B342- Coronavirus infection, unspecified
Health Condition 2: G00-G99- Diseases of the nervous system
| Control Intervention1: NIL: This is an observational study<br> | Clinical and epidemiological profile of SARS CoV-2 positive patients with neurological diseasesTimepoint: Two peaks of SARS CoV-2 pandemic | | | | Yes | False | | |
| +++ | CTRI/2021/09/036379 | 8 November 2021 | Safety and immunogenicity study of an mRNA based vaccine (HGCO19) for COVID19 in healthy adult participants. | A Prospective, Multicentre, Randomized, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects. | | Gennova Biopharmaceuticals Limited | 09-09-2021 | 20210909 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60197 | Recruiting | No | | | | 12-09-2021 | 4400 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 2/ Phase 3 | India | Dr Amit Saraf | | Gennova Vaccine Formulation Centre and Research Laboratory,
BTS-2 Building, Chrysalis Enclave, Block-2, Plot-2, International Biotech Park, Phase II, MIDC Hinjawadi, | amit.saraf@gennova.co.in | 02039166300 | Gennova Biopharmaceuticals Limited | Inclusion criteria: 1. Male and female subjectsâ?? 18- 80 years (both inclusive) for Phase II and > 18 (inclusive) years for Phase III. 2.Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator. 3. Subject should be capable and willing to give voluntary written informed consent prior to inclusion in the study. 4. Subject is able to comprehend and comply with study requirements and procedures and be able and willing to complete subject diary. 5. Negative / Non-reactive RT-PCR screening of nasopharyngeal swabs/suitable sample for SARS CoV-2. 6. Male subjects who are sexually active or married and female subjects who are sexually active or married and are of child bearing potential should be willing to follow effective birth control methods for duration of the study. | Exclusion criteria: 1. Subject with a recent history of COVID-19 infection within 3 months from Screening. <br/ ><br>2. Subjects received an investigational vaccine or vaccine which have been granted an emergency use to prevent COVID-19 infection. <br/ ><br>3. Any clinically significant laboratory values (Only Phase II). <br/ ><br>4. Any significant illness or any other current or pre-existing health condition (e.g. any major pulmonary, cardiovascular, renal, neurological, metabolic, gastro-intestinal, hepato-biliary, hematological functional abnormality, mental or physical disability, blood dyscrasia, major congenital defects, etc.) which in the opinion of the Investigator may affect the safety of the subject or the study endpoints. <br/ ><br>5. History of allergic/hypersensitivity reactions or anaphylaxis to any vaccine or components of study vaccine. <br/ ><br>6. Subject has any acute illness (moderate or severe) at the time of vaccination and/or fever (oral temperature > 38°C or > 100.4 °F (inclusive) or its equivalent for axillary and tympanic) within 48 hours prior to vaccination. <br/ ><br>7. History of cancer, organ transplant, any other clinically significant immunosuppressive condition or autoimmune disease. <br/ ><br>8. Subjects who are pregnant or breast feeding or willingness/intention to become pregnant during the study. <br/ ><br>9. Prior major surgery or any radiation therapy within 4 weeks of Screening visit. <br/ ><br>10. Positive serologic test for HIV 1 and 2, HBsAg or HCV. <br/ ><br>11. Current (within 14 days prior to Screening visit) or anticipated concomitant immune-modifying or immunosuppressive therapy (excluding inhaled, topical skin or eye drop-containing corticosteroids, low-dose methotrexate, or corticosteroids at a dose less than 20 mg/day). <br/ ><br>12. Planned or actual receipt of any vaccine other than the study intervention within 30 days before and after each study vaccination. <br/ ><br>13. Eczema or other significant skin lesion or infection at the site of vaccination. <br/ ><br>14. Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation 90 days prior to screening visit. <br/ ><br>15. Bleeding diathesis or condition associated with prolonged bleeding. <br/ ><br>16. Subjects with a history of thromboembolic events. <br/ ><br>17. History of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome <br/ ><br>18. Participating in another clinical trial within 30 days prior to Screening visit or planning to participate in another clinical trial during the study duration or planning to migrate. <br/ ><br>19. Any other condition which in the opinion of the Investigator may affect subjectâ??s safety or participation. <br/ ><br> | | Intervention1: HGCO19: HGCO19 will be administered as a 2 dose schedule on Days 1 and 29 as 0.5 mL intramuscularly<br>Control Intervention1: COVISHIELD (SII-ChAdOx1 nCoV-19): COVISHIELD will be administered as a 2 dose schedule on Days 1 and 29 as 0.5 mL intramuscularly<br> | Safety (Only Phase II) <br/ ><br>Occurrence and severity of local and systemic reactogenicity adverse events, unsolicited events and serious adverse events (SAE) <br/ ><br> <br/ ><br>Immunogenicity (Phase II and III) <br/ ><br>Geometric mean titer (GMT) as measured by IgG-ELISA against SARS-CoV-2 Spike protein. <br/ ><br>Timepoint: Safety <br/ ><br>Solicited events within 7 days and unsolicited events up to 28 days post each vaccine dose. SAEs measured throughout the study. <br/ ><br> <br/ ><br>Immunogenicity <br/ ><br>Immunogenicity at 43 day (14 days post dose 2) for Phase II and III <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/09/036380 | 8 November 2021 | Ayurveda Medicine for the management of COVID-19 | Efficacy study of Ayurveda dosage forms for the management of COVID-19 - AYUMACOV | | AMIL PHARMACEUTICALS INDIA Ltd | 09-09-2021 | 20210909 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59016 | Not Recruiting | No | | | | 07-10-2021 | 168 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant Blinded | Phase 2 | India | Dr Deepak Gautam | | Department of Medicine
Faculty of Medicine
I.M.S, B.H.U
Varanasi
Uttar Pradesh
221005 | krcreddy@bhu.ac.in | 9415813533 | Institute of Medical Sciences, Banaras Hindu University | Inclusion criteria: i. Patients able to take medicines orally. <br/ ><br>ii. Patients willing to provide signed informed consent shall be included. <br/ ><br>iii. RT-PCR (Reverse transcription polymerase chain reaction) positive patients <br/ ><br> | Exclusion criteria: i. Subjects with severe vomiting which would affect oral administration of medicine difficult. <br/ ><br>ii. Moderate and severe cases. <br/ ><br>iii. Pregnant and lactating subjects. <br/ ><br>iv. Subjects with Type 1 diabetes, malignancy and those with advanced liver or kidney disease. <br/ ><br>v. The initially included subjects who during the course of treatment progress from mild to moderate category in severity. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | 1. All-cause mortality <br/ ><br>2. WHO Ordinal Scale for Clinical Improvement of COVID-19Timepoint: 1 year | | | | Yes | False | | |
| +++ | CTRI/2021/09/036410 | 8 November 2021 | Evaluating safety of goggles with inbuilt fan in health care workers inside COVID ICU. | Comparing safety and efficacy of indigenous goggles with fan versus standard goggles in health care workers in COVID ICU.. | | All India Institute of Medical Sciences New Delhi | 10-09-2021 | 20210910 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60447 | Not Recruiting | No | | | | 20-09-2021 | 500 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India | Dr Navdeep Sokhal | | 710, Department of Neuroanaesthesiology and Critical Care, CN Center, AIIMS | drnavdeep_kumar@yahoo.com | 01126593474 | All India Institute of Medical Sciences | Inclusion criteria: Health care workers in the designated COVID Area. | Exclusion criteria: 1.Past history of COVID infection (RT-PCR positive) <br/ ><br>2.Symptomatic health care worker with suspected COVID infection | | Intervention1: Indigenous goggles with fan: Healthcare workers going to the designated COVID ICU will be<br>wearing indigenous goggles with fan for the entire shift i.e. 6 hours and safety and efficacy of these goggles will be assessed.<br>The health care workers may participate in the study multiple times(2-3) and wear the goggles according to their allocated group if they wish to participate again.<br>Control Intervention1: Standard goggles: Healthcare workers going to the <br>designated COVID ICU will be<br>wearing standard goggles for the entire shift duty i.e. 6 hours and safety and efficacy of these goggles will be assessed. The health care workers may participate in the study multiple times(2-3) and wear the goggles according to their allocated group if they wish to participate again.<br> | To compare safety for health care worker while working in the designated COVID area wearing fan powered goggles versus standard goggles in terms of: <br/ ><br>Symptomatic, RT-PCR positive COVID infection within 15 days of duty in the designated COVID area wearing goggles.Timepoint: To compare safety for health care worker while working in the designated COVID area wearing fan powered goggles versus standard goggles in terms of: <br/ ><br>Symptomatic, RT-PCR positive COVID infection within 15 days of duty in the designated COVID area wearing goggles. | | | | Yes | False | | |
| +++ | CTRI/2021/09/036411 | 8 November 2021 | A Phase III Clinical Study to Evaluate the Effect of PNB-001 in Treatment of Patients with Moderate COVID-19 Infection | A Phase III, Randomized, Open Label, Multicentric, Clinical Study to Evaluate the Efficacy and Safety of PNB-001 as an Adjunct to Standard of Care Compared to Standard of Care Alone in Treatment of Patients with Moderate COVID-19 Infection | | PNB Vesper Life Science Pvt Ltd | 10-09-2021 | 20210910 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57405 | Not Recruiting | No | | | | 27-09-2021 | 220 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 3 | India | Dr Neeta Nargundkar | | Office No. 02, 03 & 04, Second Floor, Highland Corporate Center,
Kapurbawdi Junction, Thane (W),Maharashtra, India
| drneeta@biospherecro.com | 02241006794 | Biosphere Clinical Research Pvt Ltd | Inclusion criteria: 1.Male or female patients aged between 18 and 65 years (both Inclusive). <br/ ><br>2.Patients with laboratory-confirmed SARS-CoV-2 infection as determined by PCR within 5 days of randomization. <br/ ><br>3.Patients having moderate COVID- 19 infection with SpO2: 90% to â?¤ 93% on room air or Respiratory rate more than or equal to 24 per minute. <br/ ><br>4.Radiographic infiltrates as confirmed by imaging (chest x- ray/CT-scan). <br/ ><br>5.Patients who have not received Covid-19 vaccine or received either one or two doses of the vaccine. <br/ ><br>6.Patients who are willing to sign written informed consent for participation in the study and willing to adhere to all protocol procedures. <br/ ><br>7.Eligible patients of child-bearing age (male or female) must agree to take effective contraceptive measures (including hormonal contraception, barrier methods or abstinence) with his/her partner during the study period and for at least 7 days following the last study treatment. <br/ ><br> | Exclusion criteria: 1.Patient requiring invasive mechanical ventilation. <br/ ><br>2.Patients with the following clinically significant laboratory abnormalities: SGOT, SGPT, Serum Bilirubin > 2.5 times the Upper Limit Normal (ULN)) at screening visit. <br/ ><br>3.Patients with abnormal Sr.Creatinine value of â?¥ 2 mg/dl at screening visit. <br/ ><br>4.Patients with Type 1 diabetes mellitus. <br/ ><br>5.Patients with uncontrolled Type 2 diabetes mellitus with random blood sugar level â?¥ 350 mg/dL. <br/ ><br>6.History or presence of clinically significant hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, diseases or metabolic disturbances or other relevant systemic diseases that would preclude the safe administration of the Investigational product. <br/ ><br>7.Uncontrolled hypertension (systolic blood pressure >160 mmHg, or diastolic blood pressure >100 mmHg); previous history of hypertension crisis or hypertensive encephalopathy. <br/ ><br>8. History of diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for within 4 weeks with appropriate anti-tuberculosis therapy per local guidelines at screening visit. <br/ ><br>9.Any condition for which, in the opinion of the investigator, participation would not be in the best interest of the patient (eg, compromise the well-being) or that could prevent, limit, or confound the protocol-specified assessments. <br/ ><br>10.History of hepatitis B surface antigen (HBsAg) or hepatitis C antibody (anti-HCV) positive or other clinically active liver disease. <br/ ><br>11.History of human immunodeficiency virus (HIV) antibody positive. <br/ ><br>12.History of drug or alcohol abuse according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM- V) criteria within 1 years before Screening. <br/ ><br>13.History of any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years. <br/ ><br>14.Poorly controlled heart diseases, such as NYHA class II and above cardiac insufficiency, unstable angina pectoris, myocardial infarction within 1 year before enrollment, supraventricular or ventricular arrhythmia need treatment or intervention. <br/ ><br>15.Patient received an investigational intervention (including investigational vaccines) or used an invasive investigational medical device within 30 days or 5 half-lives prior to Baseline, whichever is longer, before the signing the consent or is currently enrolled in an investigational study. <br/ ><br>16.Pregnant or breast-feeding at screening. <br/ ><br>17.Employee of the investigator or study site, with direct involvement in the proposed study or other studies under the direction of that investigator or study site, as well as family members of the employees or the investigator. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: PNB-001 with Standard of care treatment as per the latest clinical management protocol for COVID-19 as issued by Govt of India, MoHFW: PNB-001 100 mg capsule ,orally three times a day with standard of care treatment for 14 days<br>Control Intervention1: Standard of care treatment as per the latest clinical<br>management protocol for<br>COVID-19 as issued by Govt of India, MoHFW: Standard of care treatment for 14 Days<br> | 1.Time to clinical improvement (defined as the time to improvement of two points on a 7-point WHO ordinal scale from baseline till Day15). <br/ ><br> <br/ ><br>2.Mortality Rate by Day 28. <br/ ><br> Timepoint: 15 Days <br/ ><br> <br/ ><br>28 Days <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/09/036442 | 8 November 2021 | Pirfenidone in Post COVID lung disease: Randomised controlled study | Pirfenidone in Post COVID-19 lung fibrosis treatment(PirfeCT): a pilot randomised study - PirfeCT | | Sryma PB | 13-09-2021 | 20210913 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60448 | Recruiting | No | | | | 19-09-2021 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Outcome Assessor Blinded | Phase 3 | India | Sryma PB | | Department of Pulmonology and sleep medicine, PSGIMSR, Peelamedu | drsryma@gmail.com | 09447770131 | PSGIMSR, Peelamedu | Inclusion criteria: Signed Informed Consent Form <br/ ><br>Ability to comply with the study protocol in the opinion of the Investigator <br/ ><br>Confirmation of SARS-COV2 infection in previous weeks <br/ ><br>HRCT with radiological changes showing predominant fibrotic changes (comprising more than 50 % of the abnormal lung) after recovery from the acute process (HRCT chest during the screening period, performed minimum after 4 weeks of onset of illness and maximum 12 weeks post onset of illness) <br/ ><br>Oxygen saturation of < 95% at rest OR exertional desaturation of >3% on six-minute walk test | Exclusion criteria: Current use of systemic steroids (oral or intravenous) <br/ ><br>Pulmonary embolism requiring anticoagulation during the study period <br/ ><br>Invasive fungal infections requiring systemic antifungal treatments <br/ ><br>Severe or life-limiting chronic disease prior to COVID19 infection, including severe asthma, COPD, cancer, clinical dementia, IPF, or uncontrolled ischemic cardiomyopathy. <br/ ><br>Treatment with pirfenidone or nintedanib prior to Covid19 <br/ ><br>Active smoking. <br/ ><br>Pregnancy or lactation <br/ ><br>Relevant blood alterations in the analysis made during the screening period: <br/ ><br>Total bilirubin > 2 ULN <br/ ><br>AST/SGOT or ALT/SGPT > 2.5 ULN <br/ ><br>Alkaline phosphatase >3.0 ULN <br/ ><br>Creatinine Clearance <40 mL/min, calculated by the Cockcroft-Gault formula <br/ ><br>Concomitant treatments that can cause severe digestive problems, Gastric surgery in the last 3 months or similar procedures that may increase gastric intolerance <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Pirfenidone: Tablets will be started at 267mg thrice daily orally for first week. If tolerating, dose will be increased to 801mg twice daily orally in second week and to 801mg thrice daily orally in 3rd week. Dose can be modified by the treating clinician in case of side effects. Total duration of therapy will be 3 months at the maximum tolerated dose. All intervention arm patients will receive pulmonary rehabilitation.<br>Control Intervention1: no active comparator or placebo: no placebo. This arm will also recieve pulmonary rehabilitation.<br> | To investigate the effect of pirfenidone on fibrotic signs induced by COVID19 infection analyzed by <br/ ><br>oChange from Baseline in % in forced vital capacity (FVC) <br/ ><br>oChange from Baseline % fibrosis in high resolution computed tomography (HRCT) of the lung <br/ ><br>Timepoint: baseline and at 3 months | | | | Yes | False | | |
| +++ | CTRI/2021/09/036452 | 8 November 2021 | Questionnaire based assessment of the knowledge of COVID 19 and Mucormycosis in patients of a tertiary care hospital | A questionnaire based study in a dedicated tertiary care hospital to obtain a quick insight into health literacy of patients on COVID 19 associated mucormycosis, its predisposing factors and treatment during COVID 19 pandemic in India. - CAPVSEPH | | UCMSGTBH | 13-09-2021 | 20210913 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60298 | Not Recruiting | No | | | | 20-09-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Michell Gulabani | | Department of Anesthesia
University College of Medical Sciences
Delhi
Guru Tegh Bahadur Hospital Department of Anesthesia
University College of Medical Sciences
Delhi
Guru Tegh Bahadur Hospital | michellgulabani@gmail.com | 9873657500 | Department of anaesthesia UCMS/GTBH | Inclusion criteria: 1 Microbiologically proven cases of mucormycosis <br/ ><br> 2 In confirmed cases of COVID19 <br/ ><br> 3 Age between 18-70 years <br/ ><br> 4 Admitted to our hospital <br/ ><br> <br/ ><br> | Exclusion criteria: 1 Mucormycosis cases not associated with COVID 19 <br/ ><br>2 Mucormycosis patients on invasive ventilation in intensive care unit. <br/ ><br>3 Other fungal infections in COVID 19 <br/ ><br> <br/ ><br> | Health Condition 1: O- Medical and Surgical
Health Condition 2: B488- Other specified mycoses
Health Condition 3: B488- Other specified mycoses
| Control Intervention1: nil: nil<br> | 1 Questionaire based assessment of the level of knowledge among patients of treated COVID 19 who developed mucormycosis about their disease, its course and treatment. <br/ ><br>2 Evaluating socio-economic and demographic factors affecting the diagnosis and management of post COVID 19 mucormycosis. <br/ ><br>3 Patient behavior affecting the predisposing factors. <br/ ><br> <br/ ><br>Timepoint: At a single point of time when patient is contacted . <br/ ><br> <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/09/036461 | 8 November 2021 | Haemodialysis adherence,Stress and Quality of Life among End-stage renal disease patients during Covid -19 Pandemic
| Haemodialysis adherence perceived stress and Quality of Life among End-stage renal disease patients during Covid -19 Pandemic
- Mixed method approach
| | Nil | 13-09-2021 | 20210913 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60217 | Not Recruiting | No | | | | 21-09-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India | ASERMA SUBATHRA | | College of Nursing
AIIMS
Sijua Post Khordha District
Bhubaneswar Odisha College of Nursing
AIIMS
Sijua Post
Khordha District
Bhubaneswar
Odisha | nurs_serma@aiimsbhubaneswar.edu.in | 8919996722 | College of Nursing AIIMS Bhubaneswar | Inclusion criteria: - adult and conscious <br/ ><br>- more than six months on haemodialysis <br/ ><br>- able to read, understand English, Odiya, Telugu and <br/ ><br>- agreed to participate in the study <br/ ><br> | Exclusion criteria: disoriented <br/ ><br>not willing to participate and uncooperative <br/ ><br>having blabbered speech <br/ ><br> | Health Condition 1: J00-J99- Diseases of the respiratory system
Health Condition 2: N186- End stage renal disease
| | Estimate the numerous challenges includes level of Adherence hemodialyis ,Qulaity of life and Level perceived stress encountered by ESRD Patients during Covid -19Timepoint: One point in time observational Study | | | | Yes | False | | |
| +++ | CTRI/2021/09/036484 | 8 November 2021 | Comparative evaluation of McGrath and C-MAC videolaryngoscope on intubation performance in infants | Comparative evaluation of McGrath and C-MAC video laryngoscopes intubation performance for training a novice in a COVID simulating infant mannequin using protective face equipment-A randomized crossover trial | | DrRidhima Sharma | 14-09-2021 | 20210914 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60500 | Not Recruiting | No | | | | 21-09-2021 | 30 | Interventional | Randomized, Crossover Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | N/A | India | Ridhima Sharma | | Department of Paediatric Anaesthesia ,Second Floor,Room no.3 Department of Paediatric Anaesthesia ,Second Floor,Operation theater complex | drridhimasharma@yahoo.com | 08054549458 | Post Graduate Institute of Child health Noida | Inclusion criteria: 1.Doctors and Paramedical staff from a multidisciplinary team working in a tertiary care super speciality Paediatric centre converted into a COVID care centre. <br/ ><br>2.No experience on any of the video laryngoscope <br/ ><br> | Exclusion criteria: 1.Previous experience of intubating in a similar setting (i.e. with video laryngoscope within an intubation box <br/ ><br>2.Refuse to give consent <br/ ><br> | | Intervention1: Comparitive evaluation of McGrath videolaryngoscope intubation performance with C-MAC videolaryngoscope: One month<br>Control Intervention1: Participants will use C-MAC videolaryngoscope for intubation in the infant manikin: One month<br> | The Primary endpoint of this study is to compare the time to intubation between the two groups. Group 1 McGrath and Group 2; C-MACTimepoint: One month | | | | Yes | False | | |
| +++ | CTRI/2021/09/036489 | 8 November 2021 | Device validation study for detecting likely presnce of COVID-19 | Development, validation, pilot deployment of an ultra scalable technology SWAASA AI, as an auxiliary to COVID 19 rapid test. | | Cellular and Molecular Platforms | 14-09-2021 | 20210914 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60610 | Recruiting | No | | | | 22-09-2021 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Narayana Rao Sripada | | FLAT NO 408,DREAM CASTLE NIZAMPET ROAD, KUKATPALLY FLAT NO 408,DREAM CASTLE NIZAMPET ROAD, KUKATPALLY | padmalathamdgen@gmail.com | 9246620072 | Andhra Medical College | Inclusion criteria: Male or female patients, 18 years of age and over. <br/ ><br>Patients able to read, understand and sign the Informed Consent Form. <br/ ><br>Newly diagnosed COVID 19 Patients. <br/ ><br> | Exclusion criteria: Patients less than 18 years of age <br/ ><br>Pregnant females. <br/ ><br>Asymptomatic patients attending isolation ward for COVID testing <br/ ><br>Patients on ventilators support <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | Validation of the SWAASA AI Platform in detecting likely presence of COVID-19 by comparing with the final clinical diagnosis based on test results of a standard reference test or tests.Timepoint: 5 months | | | | Yes | False | | |
| +++ | CTRI/2021/09/036490 | 8 November 2021 | Evaluation of allergic reactions following COVID -19 vaccination in patients with documented allergies | Evaluation of allergic reactions following COVID -19 vaccination in patients with documented allergies | | ICMR | 14-09-2021 | 20210914 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60651 | Not Recruiting | No | | | | 24-09-2021 | 255 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Nithya Gogtay | | Department of Clinical Pharmacology, 1st Floor New Building, Seth G.S.M.C and K.E.M Hospital, Acharya Donde Marg,
Parel, Mumbai 400012 | njgogtay@hotmail.com | 9820495836 | Seth G.S.M.C and K.E.M Hospital | Inclusion criteria: Inclusions are those with <br/ ><br>any allergic diatheses, including those <br/ ><br>with food and/or drug allergy and/ <br/ ><br>or history of anaphylaxis who had <br/ ><br>undergone thorough clinical evaluation <br/ ><br>and allergy testing. | Exclusion criteria: Exclusions are patient less than 18 <br/ ><br>years of age, incomplete demographics <br/ ><br>and incomplete allergy testing data. | Health Condition 1: T784- Other and unspecified allergy
| | â?¢ Proportion of patients with history of drug or food allergy or history of anaphylaxis or combination, developing allergic reaction with COVID 19 vaccine. <br/ ><br>â?¢ Proportion of patients with documented allergic diathesis developing allergic reaction with either dose of COVID-19 vaccine. <br/ ><br>Timepoint: Baseline (Retrospective database study, data will be extracted at single time point) | | 24/09/2021 | | Yes | False | | |
| +++ | CTRI/2021/09/036537 | 8 November 2021 | Co-relation of blood sugar levels prior ,during and post hospitalization in Covid -19 patients | A study of patients admitted for Covid-19 infection with respect to their glycemic status before and during hospitalization, and after discharge, and its correlation with their outcomes. - DM Covid | | MMRS Maharashtra medical research society | 15-09-2021 | 20210915 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60270 | Not Recruiting | No | | | | 01-10-2021 | 500 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Other Blinding and masking:Not Applicable | N/A | India | Dr Kishor Shelgikar | | Department of Medicine ,ICU and Non Icu ,968,Senapati Bapat Rd,
Sheti Mahamandal ,Shivaji Co-operative Housing Society,Ramoshivadi ,Wadarvadi Pune
| kishel@hotmail.com | 912041097777 | Ratna Memorial Hospital | Inclusion criteria: All adults males and females with Covid-19 positive status admitted at Ratna Memorial Hospital | Exclusion criteria: Non-Covid Status | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | Complications during hospitalization <br/ ><br> Outcomes at discharge <br/ ><br> Glycemic status of Covid positive patients at discharge <br/ ><br> Type of new-onset diabetes in survivors at 6 monthsâ?? follow-up <br/ ><br>Timepoint: It is a retrospective trial.Subjects will be followed upto 6 months post discharge <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/09/036552 | 8 November 2021 | To understand the pattern and profile of COVID-19 related black fungus disease | Clinical profile of Post Covid Mucormycosis in relation to
the oral manifestations. | | All India Institute of Medical Sciences Raipur | 16-09-2021 | 20210916 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60672 | Not Recruiting | No | | | | 30-09-2021 | 150 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Virat Galhotra | | Department of Dentistry, C Block Ground Floor Hospital Building | virat@aiimsraipur.edu.in | 09216274600 | All India Institute of Medical Sciences Raipur | Inclusion criteria: Patients with age group above 18yrs <br/ ><br>Patients with a history of Covid positive <br/ ><br>Diagnosed case of mucormycosis. <br/ ><br>Patients with and without comorbities. <br/ ><br>Giving positive informed consent <br/ ><br> | Exclusion criteria: Patient who refused to give consent | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B465- Mucormycosis, unspecified
| Intervention1: NIL: NiL<br>Control Intervention1: NIL: NIL<br> | oral manifestations of post covid mucormycosis.Timepoint: Data collected only once | | | | Yes | False | | |
| +++ | CTRI/2021/09/036553 | 8 November 2021 | To study the quality of life among the patients receiving prothesis after surgical treatment of post COVID Black fungus | Evaluation of the effect of prosthodontic
rehabilitation on quality of life and
psychological distress in maxillectomy patients
after post-covid mucormycosis- a prospective
clinical study. | | All India Institute of Medical Sciences Raipur | 16-09-2021 | 20210916 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60665 | Not Recruiting | No | | | | 30-09-2021 | 25 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India | Virat Galhotra | | Department of Dentistry, C Block, Ground Floor. Hospital Block 01. | virat@aiimsraipur.edu.in | 09216274600 | All India Institute of Medical Sciences Raipur | Inclusion criteria: a)All the patients referred for Prosthodontic rehabilitation after being planned for maxillectomy in post covid mucormycosis patients, having age group of 18 years and above will be enrolled, irrespective of gender. <br/ ><br> <br/ ><br>b)Patients with defect involving hard palate only. <br/ ><br> <br/ ><br>c)Patients showing compliance for required visits during the study. <br/ ><br> | Exclusion criteria: a)Completely edentulous arch, <br/ ><br>b)Associated midfacial defects, <br/ ><br>c)Involvement of mandible or tongue, <br/ ><br>d)Defect of soft palate only, <br/ ><br>e)Patients not willing to undergo prosthodontic treatment. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B465- Mucormycosis, unspecified
| Intervention1: Surgical, intermediate and definitive obturator prosthesis: Surgical, intermediate and definitive obturator prosthesis will be fabricated and used by the participants at various stages of healing of the defect. wich includes 2 weeks after surgery, 2 weeks after interim obturator and 12 weeks after final obturator, a total of 16 weeks follow -up<br>Control Intervention1: Not Applicable: Not Applicable<br> | Prosthodontic rehabilitation on Quality of Life and Psychological Distress levels of maxillectomy patients after post covid mucormycosis assessed by EORTC QLQ H and N35 questionnaireTimepoint: Baseline Preoperative (T0), 2 weeks Postoperative (T1), 2 weeks after insertion of intermediate obturator (T2), just before insertion of definitive obturator (T3), and 12 weeks after the insertion of definitive obturator (T4). | | | | Yes | False | | |
| +++ | CTRI/2021/09/036568 | 8 November 2021 | Exercise practices among pregnant women during COVID-19 | Knowledge, Attitude and Practices about exercises among pregnant women during COVID-19 pandemic | | Preetha R | 16-09-2021 | 20210916 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60664 | Not Recruiting | No | | | | 01-10-2021 | 332 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Preetha R | | Department of Physiotherapy
Manipal College of Health Professions
Manipal Academy of Higher Education,Manipal | preetha.r@manipal.edu | 9945670669 | Manipal College of Health Professions | Inclusion criteria: Pregnant women aged between 18 to 40 years with a period of gestation > 20 weeks and those who should be able to read and understand English or Kannada language <br/ ><br> | Exclusion criteria: Those pregnant women who have been advised bed rest or Incompetent cervix or Bad obstetric history or Intra uterine growth restriction <br/ ><br> or Placenta previa or Advised not to exercise by treating obstetrician <br/ ><br> | | Intervention1: NIL: NIL<br> | Content validated Knowledge, Attitude and Practices questionnaire about exercises among pregnant women during COVID-19 pandemicTimepoint: Single time during study period | | | | Yes | False | | |
| +++ | CTRI/2021/09/036569 | 8 November 2021 | Comparison of health factors among normal healthy adults and those after covid affection. | Comparison of quality of life, functional capacity and lung function among post Covid-19 and age matched healthy adults | | Jaimala V Shetye | 16-09-2021 | 20210916 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59462 | Not Recruiting | No | | | | 15-10-2021 | 56 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Nidhi M Ranka | | Room no 4, 1st floor, PT School and Centre, Seth GS Medical College, KEM Hospital, Parel, Mumbai | jaimalavs@gmail.com | 9323076545 | PT School and Centre, Seth GS Medical College, KEMH | Inclusion criteria: â?¢ Subjects with confirmed diagnosis of Covid-19 based on RTPCR <br/ ><br>â?¢ Who were hospitalized and had moderate to severe illness based on clinical spectrum given in Maharashtra state Revised Guidelines on Clinical Management of COVID â?? 19[10] <br/ ><br>â?¢ have completed at least 3 months post diagnosis <br/ ><br> <br/ ><br> | Exclusion criteria: For subjects with Covid-19 patients: <br/ ><br>a)Asymptomatic, mild, critically ill on clinical spectrum /intubated (Maharashtra state Revised Guidelines on Clinical Management of COVID â?? 19. This is to avoid two extremes of condition so that the group is homogenous in severity. <br/ ><br>b)Pre-existing musculoskeletal, neurological , heart and lung condition, psychiatric disorder taking any treatment <br/ ><br>c)Those who have smoked minimum 100 cigarettes in their lifetime <br/ ><br> <br/ ><br>For healthy subjects: <br/ ><br>a)Subjects with musculoskeletal, neurological, heart and lung condition, psychiatric disorder taking any treatment. <br/ ><br>b)Those who have smoked minimum 100 cigarettes in their lifetime <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | 1. EQ- 5D-5L index <br/ ><br>it is derived from EQ-5D-5L questionnaire <br/ ><br> <br/ ><br>Timepoint: once at baseline | | | | Yes | False | | |
| +++ | CTRI/2021/09/036572 | 8 November 2021 | a prospective observational study on post surgery morbidity and mortality in patients having a prior history of covid-19 | A prospective observational study on post-covid surgical mortality and morbidity | | BLKMax superspecialty hospital | 16-09-2021 | 20210916 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60169 | Not Recruiting | No | | | | 23-09-2021 | 1950 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India | Dr Saloni Paranjpe | | OT complex, 2nd Floor, BLK Max superspecialty hospital, Pusa road, new delhi pusa road, new delhi | priyankar.sarkar@blkhospital.com | 9871764586 | BLK Max Superspecialty hospital | Inclusion criteria: All patients undergoing surgery under general or regional anesthesia including those with current and prior covid and those without previous covid history <br/ ><br> | Exclusion criteria: 1. Patients undergoing surgery under local anaesthesia or monitored anaesthesia care <br/ ><br>2.Patients undergoing cardiac surgery or neurosurgery <br/ ><br>3. Patients under 18 years of age <br/ ><br>4. International patients <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | 30-day postoperative mortality <br/ ><br>Timepoint: postopetative period day 30 <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/09/036579 | 8 November 2021 | Effect of COVID-19 vaccination in Rheumatoid arthritis patients | Clinical and immunological responses to COVID-19 vaccination in Rheumatoid arthritis patients on treatment with DMARDsâ?? A Prospective Cohort Study
| | AIIMS Bibnagar | 16-09-2021 | 20210916 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60059 | Not Recruiting | No | | | | 30-09-2021 | 96 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Madhavi Eerike | | Department of Pharmacology All India Institute of Medical Sciences - Bibinagar
Hyderabad Metropolitan Region Telangana | dr.madhavieerike@gmail.com | 08685279338 | AIIMS Bibinagar | Inclusion criteria: Age >18 years <br/ ><br>Both sex <br/ ><br>Willing to participate in the study <br/ ><br>Diagnosed case of rheumatoid arthritis (clinically, radiologically, laboratically) <br/ ><br>Both seropositive and seronegative RA <br/ ><br>On treatment with DMARDS (single or combination) <br/ ><br>Intend to receive vaccine against COVID-19 <br/ ><br>Post COVID-19 (3month after recovery) <br/ ><br> <br/ ><br> | Exclusion criteria: Cancer and other autoimmune/ Immune suppressants disorders <br/ ><br>Patients on immunosuppressive therapy other than DMARDs <br/ ><br>Allergy and Contraindication to vaccination <br/ ><br>Patients with active SARS CoV-2 infection <br/ ><br>Patients on alternative systems of medicine for RA <br/ ><br>Patients with known interstitial lung disease <br/ ><br>Pregnant or breastfeeding woman <br/ ><br> | Health Condition 1: M059- Rheumatoid arthritis with rheumatoid factor, unspecified
| Intervention1: Nil: Nil<br> | 1.Immunological response- Number of patients with neutralizing antibodies after 1 month, 3months and 6months post vaccination <br/ ><br>2.Number of patients with symptomatic infection by COVID-19 during follow-up period <br/ ><br>3.Number of patients with worsening /improvement of clinical symptoms of RA <br/ ><br>Timepoint: one three and six months <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/09/036581 | 8 November 2021 | A Pilot Study for the Collection Of Vocalized Individual Digital Cough Sounds from patients with suspected COVID-19 in India | A Pilot Study for the Collection Of Vocalized Individual Digital Cough Sounds from patients with suspected COVID-19 in India | | ResApp Health Limited | 16-09-2021 | 20210916 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59988 | Recruiting | No | | | | 22-09-2021 | 220 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Sunil Yadav | | Villa No. D-103, Plot No. Bgh-A, UPSIDC Housing Sector, Surajpur, Gautam Buddha Nagar - 201310, India | sunil@triomics.in | 9310816793 | Triomics Healthcare Private Limited | Inclusion criteria: 1. Be aged 18 years and older; <br/ ><br>2. Be able to provide informed consent; <br/ ><br>3. Be willing to follow study procedures; <br/ ><br>4. Be able to provide at least 5 coughs (voluntary <br/ ><br> and/or spontaneous); and <br/ ><br>5. Is either: <br/ ><br> (i)an in-patient at a study site who are <br/ ><br> experiencing mild to moderate symptoms of COVID- <br/ ><br> 19 based on the ICMR guidelines, and has <br/ ><br> undergone a positive COVID-19 rt-PCR or rt-qPCR <br/ ><br> test in the preceding 48 hours; or <br/ ><br> (ii)at a study site and is needing a COVID-19 <br/ ><br> rt-PCR or rt-qPCR test. <br/ ><br> | Exclusion criteria: Participant has one or more medical contraindication to voluntary cough, including the following: <br/ ><br>1. Severe respiratory distress; <br/ ><br>2. History of pneumothorax; Eye, chest, or abdominal surgery within 3 months of enrolling in the study; <br/ ><br>3. Patients requiring continuous oxygen or ventilator support; and <br/ ><br>4. Hemoptysis (coughing up of blood) within 1 month of enrolling for the study; or <br/ ><br>5. Patients requiring continuous oxygen or ventilator support; <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | Collection of cough sound recordings, current medical symptoms, and medical history on a single occasion from 120 COVID-19 negative or positive participants as identified by PCR. <br/ ><br> <br/ ><br>Collection of cough sound recordings, current medical symptoms, medical history, and medical treatment information on 3 distinct occasions (day 0, day 2, day 4) from 100 individuals with a known positive COVID-19 PCR result. <br/ ><br>To develop a post data collection algorithm to detect COVID-19 and the severity of COVID-19 and determine the accuracy of the developed algorithm with a combination of collected cough sound analysis and medical symptoms to detect COVID-19 and the severity of COVID-19 using PCR as a reference standard.Timepoint: Screening/Baseline Visit, Day 2 and Day 4. | | | | Yes | False | | |
| +++ | CTRI/2021/09/036590 | 8 November 2021 | Anti cancer therapy in COVID-19 time | The safety of symptom based administration of chemotherapy in cancer patients during the ongoing COVID-19 pandemic | | NCI AIIMS | 17-09-2021 | 20210917 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=53993 | Not Recruiting | No | | | | 29-09-2021 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Akash Kumar | | Room No 1, 1st Floor, Academic Block, NCI - AIIMS, Badsa, Jhajjar, Haryana | akashjha08@yahoo.com | 9910850134 | NCI AIIMS | Inclusion criteria: Diagnosis of malignancy (solid, hematologic) <br/ ><br>Had received any form of systemic therapy <br/ ><br>(chemotherapy, harmonal, targeted, <br/ ><br>immunotherapy, metronomic) in between 1st <br/ ><br>March 2020 to 28th February 2021 <br/ ><br>Histopathological diagnosis of cancer | Exclusion criteria: Had documented personal or family history of COVID-19 infection prior to systemic therapy administration <br/ ><br>Patients who had received anti-cancer systemic therapy at different cancer center before registration during the study period | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: C00-D49- Neoplasms
| Control Intervention1: None: None<br> | To evaluate the risk of COVID-19 related death among cancer patients during the systemic anti-cancer therapyTimepoint: 28th february 2021 | | | | Yes | False | | |
| +++ | CTRI/2021/09/036606 | 8 November 2021 | Finding out the effect of oxygen therapy in awake prone position in patient with covid pneumonia in tertiary care hospital | Analysis of the Outcome of awake proning in patients with COVID pneumonia in Tertiary care hospital | | Indira Gandhi Medical College and Research Institute Puducherry | 17-09-2021 | 20210917 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60549 | Not Recruiting | No | | | | 23-09-2021 | 250 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Pratheeba Natrajan | | Hospital Block
Department of Anaesthesia
Ground Floor
Indira Gandhi Medical College and Research Institute
Puducherry
| pratheeba.rk@gmail.com | | Indira Gandhi Medical College and Research Institute | Inclusion criteria: Laboratory confirmed COVID-19 infection with severe hypoxemic respiratory failure defined as respiratory rate â?¥30 breaths/min and oxyhemoglobin saturation (SpO2) â?¤93% while receiving supplemental oxygen 6 L/min via nasal cannula and 15 L/min via non-rebreather facemask.. <br/ ><br>2.PF ratio <300. <br/ ><br> | Exclusion criteria: patients who are drowsy or uncooperative, <br/ ><br>2. ophthalmic (e.g. glaucoma), cervical (e.g. spondylosis) or abdominal pathologies (including pregnancy). <br/ ><br>3.haemodynamically unstable patients <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Awake Prone ventilation: Patients will be required to adopt the prone position for 30 minutes to two hour each session and then lying on the left lateral followed by by sitting up with head end elevated (30 to 60) fol-lowed by right lateral to a total of five sessions a day, each spaced three hours apart during awake hours. Haemodynamics and oxygen saturation will be charted at 0, 30 and 60 minutes from the start of each session<br>Control Intervention1: Control Group: data will be taken from the routine care patient in ICU<br> | To study the number of patients requiring invasive support.Timepoint: 2 weeks | | | | Yes | False | | |
| +++ | CTRI/2021/09/036610 | 8 November 2021 | Clinical study of Mulmina Mango as a Health Supplement in Management of Post-COVID-19 | A Prospective, Open-label, Randomized, Multicenter, Controlled Clinical Trial to Assess the Efficacy and Safety of Mulmina Mango as a Health Supplement in Management of Post-COVID-19 with Standard of Care Treatment among Mild to Moderate COVID-19 recovered subjects | | Jagdale HealthCare | 17-09-2021 | 20210917 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60538 | Recruiting | No | | | | 24-09-2021 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India | Subham Dutta | | 2nd Main Road, Building #06, 3rd Floor. Arekere, Sarvobhogam Nagar | raghavendrakv16@gmail.com | 9845345469 | Jagdale Industries Pvt Ltd | Inclusion criteria: 1.Subjects who have signed the written informed consent form approved by Ethics Committee after understanding the explanations regarding the clinical trial <br/ ><br>2.Adult male and female subjects, aged between 20 to 50 years (both inclusive) <br/ ><br>3.Mild to Moderate COVID-19 recovered subjects (patients classified as mild or moderate as per Clinical Management protocol for COVID-19 by MoHFW) and who require treatment for Post-COVID-19 conditions <br/ ><br>4.Subjects with history of positive RT-PCR test (reverse transcription- polymerase chain reaction) result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2) not more than 28 days (4 weeks) at the time of screening. <br/ ><br>5.Subjects experiencing any signs or symptoms or any non-serious conditions after testing negative to SARS-CoV-2 infection <br/ ><br>6.Subjects with history of negative RT-PCR report at the time of screening <br/ ><br>7.Female subjects reported negative pregnancy testing at the time of screening <br/ ><br>8.Subjects who can read, understand, and fill out/ respond to questionnaires and diary card <br/ ><br>9.Those who can comply with the requirements and process in the clinical trial. <br/ ><br> | Exclusion criteria: 1.Subjects with any active autoimmune disorder <br/ ><br>2.Subjects with the history of major active or chronic unstable psychiatric illness (e.g., bipolar disorder, obsessive compulsive disorder, and schizophrenia) <br/ ><br>3.Female participants who are pregnant or breastfeeding, lactating, or planning a pregnancy during the clinical trial period <br/ ><br>4.Subjects with history of hypersensitivity or severe allergic reactions <br/ ><br>5.Subjects with the history of stage 2 hypertension or subjects with systolic blood pressure (SBP) â?¥140 mmHg and/or diastolic blood pressure (DBP) â?¥90 mmHg at the time of screening <br/ ><br>6.Subjects with ALT or AST level exceeds 3 times the normal upper limit of the research institute at the time of screening <br/ ><br>7.Subjects with self-reported history of chronic diseases such as diabetes, diabetic ketoacidosis, heart disease, liver disease, and kidney disease conditions <br/ ><br>8.Post-COVID-19 subjects with or progressive towards serious sequelae conditions such as Ischemic heart disease, Thromboembolic complications, Mucormycosis or any other serious conditions <br/ ><br>9.Subjects with active or untreated malignancy or recovered from malignancy <br/ ><br>10.Subjects with conditions precluding ingestion or absorption of the investigational product, inflammatory bowel disease, short bowel syndrome, or other major gastrointestinal disease. <br/ ><br>11.Subjects who are on haemodialysis or peritoneal dialysis <br/ ><br>12.Subjects with the history of asthma/ Chronic Obstructive Pulmonary Disease (COPD) <br/ ><br>13.Subjects with severe blood loss within 3 months prior to screening or have known any traits of hemoglobin abnormalities <br/ ><br>14.Subjects who require intervention of any multivitamin/ nutritional/ antioxidant/immune booster supplements <br/ ><br>15.Subjects with the history of known infection with Human immunodeficiency virus (HIV), Hepatitis B & Hepatitis C (self-reported) <br/ ><br>16.Subjects with the history of organ transplant or stem cell transplant <br/ ><br>17.Drug abuse/alcohol abuse subjects (self-reported) <br/ ><br>18.Subjects with untreatable or terminal stage illness <br/ ><br>19.Subjects who participated in another clinical trial within 1 month before screening <br/ ><br>20.Subjects with any chronic condition or any illness that in the judgement of investigator makes the subject inappropriate for entry into this clinical trial <br/ ><br>21.Subjects not willing to give voluntary consent and follow protocol procedures. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | 1. Immune markers (SARS-CoV-2-specific IgG, and Immunoglobulin M [IgM]) <br/ ><br>2. Inflammatory markers (C-reactive protein [CRP], Lactate Dehydrogenase [LDH], Interleukin-6 [IL-6], Neutrophil to Lymphocyte ratio [NLR], Ferritin, and Erythrocyte sedimentation rate [ESR]) <br/ ><br>3.Antioxidant markers (Glutathione [GSH] and Superoxide Dismutase [SOD]) <br/ ><br>4.Stress markers (Cortisol and Dehydroepiandrosterone [DHEA]) <br/ ><br>5.Saturated oxygen level (SpO2) at rest <br/ ><br>6.Questionnaires: <br/ ><br>I.Functional status: Post-COVID Functional Status (PCFS) on a 5-point ordinal scale (0 to 4 grades) <br/ ><br>II.Quality of life: EuroQoL (EQ-5D-5L) Questionnaire.Timepoint: Day 1, 45 and 91 | | | | Yes | False | | |
| +++ | CTRI/2021/09/036611 | 8 November 2021 | Yoga on healthcare professionals burnout during COVID-19 pandemic | Effect of Yoga on burnout in Health-Care Professionals working during COVID-19 pandemic | | NA | 17-09-2021 | 20210917 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56759 | Not Recruiting | No | | | | 04-10-2021 | 82 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Gautam Sharma | | Center for Integrative Medicine and Research (CIMR), Room No: 7004, 7th floor, Convergence Block, All India Institute of Medical Sciences, Ansari Nagar, | drgautamsharma12@gmail.com | 01126549326 | All India Institute of Medical Sciences (AIIMS), New Delhi | Inclusion criteria: 1. Healthcare professionals (including consultants, residents, nurses, nursing assistants, therapists & technicians) working during the COVID-19 pandemic who are directly exposed to patients (regular physical contact with patients) for at least the past one month. <br/ ><br>2. Willingness and ability to practice specifically designed yoga protocol, comply with trial and follow-up procedures. | Exclusion criteria: 1. Denied informed consent. <br/ ><br>2. Pregnant women. <br/ ><br>3. Currently enrolled in any other trial. <br/ ><br>4. Healthcare professionals with current/recent COVID-19 infection within the past one month, and/or with severe COVID-19 sequelae. <br/ ><br>5. Already practicing yoga for more than the last one month or taking any other behavioral/psychological interventions. <br/ ><br>6. Any significant condition or co-morbidity that clinicians deem unfit for participation in the study. | | Intervention1: YOGA: Specifically designed yoga protocol will be used. Total 6 online yoga sessions (3 training session in week-1, and 3 followup sessions once in 10 days between week-2 to week-6) will be conducted. Participants will also be encouraged to practice yoga regularly till the end of follow-up period (6 weeks).<br>Control Intervention1: NA: None<br> | Change in average score of Copenhagen Burnout Inventory (CBI)Timepoint: Baseline, and 6 weeks | | | | Yes | False | | |
| +++ | CTRI/2021/09/036631 | 8 November 2021 | What are the properties / features of COVID-19 vaccine that would make it more acceptable for Indians and how much are they willing to spend for buying such a vaccine | Prediction of factors influencing Indian adultsâ?? likelihood of accepting any COVID-19 vaccination and their willingness to pay â?? a discrete choice experiment study. | | Seth GS Medical College KEM Hospital | 20-09-2021 | 20210920 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56540 | Recruiting | No | | | | 24-09-2021 | 10000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Jeffrey Pradeep Raj | | Dept. of Clinical Pharmacology
1st floor New building
Seth GS Medical College & KEM Hospital, Parel Mumbai | jpraj.m07@gmail.com | 7904286189 | Seth GS Medical College & KEM Hospital | Inclusion criteria: 1.All consenting adults of any gender, age 18 years and above <br/ ><br>2.A citizen of India who has been residing in India at least past 6 months (self-reported). <br/ ><br>3.Survey forms that are filled 100 percent. <br/ ><br> | Exclusion criteria: 1.Non-resident Indians (NRIs) and overseas citizen of India (OCIs) [despite having a Passport or dual citizenship] <br/ ><br>2.Those who do not answer the trap question correctly (see section 5f for more details on trap question). <br/ ><br>3. Incompletely filled survey forms [anything less than 100 percent] <br/ ><br> | | Intervention1: Nil: Not applicable<br>Control Intervention1: Nil: Not applicable<br> | To identify the key attributes of COVID-19 vaccine for acceptability of the vaccine by the Indian populationTimepoint: At Baseline | | | | Yes | False | | |
| +++ | CTRI/2021/09/036632 | 8 November 2021 | Epidemiology of Covid 19 and Review of Ayurvedic interventions on its Management. | Epidemiology of Covid-19 and Review of Ayurvedic interventions on its Management. | | All India Institute of Ayurveda | 20-09-2021 | 20210920 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60565 | Not Recruiting | No | | | | 26-09-2021 | 700 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Alka Babbar Kapoor | | All India Institute of Ayurveda
Hospital Building
First Floor
Administration Wing
Room No.5 Same as Address 1 | drrky68@gmail.com | 09412148437 | All India Institute of Ayurveda | Inclusion criteria: a) Age : 18 years and above <br/ ><br>b) Gender: No bar (Male. Female, Others) <br/ ><br>c) Willing to participate in the study | Exclusion criteria: <br/ ><br>Not willing to give consent | | | 1. Epidemiology of Covid 19 and to find out determinants of risk of transmission of Covid-19 infection <br/ ><br>2.Review of Impact of Ayurveda based practices on Covid -19 infection <br/ ><br>3.Systematic Review of Various Ayurvedic interventions on Covid-19 infection <br/ ><br> Timepoint: April 2024 <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/09/036634 | 8 November 2021 | Survey To Assess Knowledge And Attitude Of Healthcare Workers Towards COVID-19 Vaccination In A Tertiary Care Hospital | Survey To Assess Knowledge And Attitude Of Healthcare Workers Towards COVID-19 Vaccination In A Tertiary Care Hospital | | Dr Vuppalanchi Bhavani | 20-09-2021 | 20210920 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55904 | Not Recruiting | No | | | | 01-10-2021 | 329 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Vuppalanchi Bhavani | | Department of Clinical Pharmacology and Therapeutics, 2nd floor, old building, Nizams Institute of Medical Sciences, Punjagutta, Hyderabad Punjagutta | ushapingali@yahoo.com | 9849574143 | Nizams Institute of Medical Sciences | Inclusion criteria: All the Healthcare workers of NIMS Hospital, Hyderabad | Exclusion criteria: Participants unwilling to take part in the study | | | To assess the knowledge and attitude towards COVID-19 vaccination among healthcare workers in a tertiary care hospital <br/ ><br>Timepoint: 1 week | | | | Yes | False | | |
| +++ | CTRI/2021/09/036645 | 8 November 2021 | Safety and efficacy evaluation of human Mesenchymal Stem Cells (MSCs) in patients with SARS-CoV-2 infection | Evaluation of Safety and Efficacy of Human Umbilical
Cord Derived Mesenchymal Stem Cells (MSCs) in
Patients with Moderate to Severe SARS-CoV-2 Infection
(SpO2 â?¤94% and Respiratory Rate â?¥24 per minute): An
Adaptive, Seamless Phase-1/Phase-2, Prospective,
Open-labelled, Multi-center Study | | LifeCell International Pvt Ltd | 20-09-2021 | 20210920 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60010 | Not Recruiting | No | | | | 26-09-2021 | 50 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 1/ Phase 2 | India | Dr Chirayu Padhiar | | 24 Vandalur
Keelambakkam Main Rd
Keelakotaiyur
Chennai | drchirayu.p@lifecell.in | 8754467277 | LifeCell International Pvt Ltd | Inclusion criteria: 1 A positive reverse transcription, polymerase chain reaction (RT-PCR) assay for SARS-CoV-2. <br/ ><br>2 Patients currently hospitalized with moderate to severe SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus) infection (COVID19) satisfying the criteria as below: <br/ ><br>a. Peripheral capillary oxygen saturation (SpO2) â?¤94%. <br/ ><br>b. Respiratory rate â?¥24 breaths per minute with/without breathlessness. <br/ ><br>3 Lower respiratory tract infection at screening suggestive of moderate to severe COVID19 disease: radiographic infiltrates on X-ray chest (PA view) or chest spiral CT scan. <br/ ><br>4 Patients with onset of COVID19 symptoms within 5 days prior to screening. <br/ ><br>5 Willing and able to provide written informed consent prior to performing any study related procedure. <br/ ><br> | Exclusion criteria: 1 Patients with mild COVID19 disease (SpO2 >94%, and/or respiratory rate <24 breaths per minute. <br/ ><br>2 High risk individuals: <br/ ><br>a Age > 60 years <br/ ><br>b Known patients of any cardiovascular disease, hypertension, and CAD <br/ ><br>c Known patients of type-1 or type-2 diabetes mellitus <br/ ><br>d Any immunocompromised states <br/ ><br>e History of chronic lung/kidney/liver disease <br/ ><br>f History of any cerebrovascular disease <br/ ><br>g Obesity <br/ ><br>3 Participation in any other clinical trial of an experimental treatment for COVID-19. <br/ ><br>4 Evidence of multiorgan failure. <br/ ><br>5 Mechanically ventilated (including V-V ECMO or V-A ECMO). <br/ ><br>6 Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times upper limit of normal (ULN). <br/ ><br>7 Creatinine clearance <30 mL/min using the Cockcroft-Gault formula. <br/ ><br>8 Pregnant or breast-feeding women. <br/ ><br>9 Anticipated discharge from the hospital or transfer to another hospital within 72 hours of enrolment. <br/ ><br>10 Hypersensitivity to active ingredient(s) or any of the excipients of the study formulation. <br/ ><br>11 Patient who declines to sign the written informed consent. <br/ ><br>12 Patients with any other clinical conditions which, in the opinion of the investigator, would not allow for the safe completion of the protocol. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: MESOCEL: MESOCEL: Human Umbilical Cord Mesenchymal Stem Cells<br>(hUC-MSCs). All patients in phase 1 study and patients randomized to the study<br>arm in phase 2 study will receive human umbilical cord derived MSCâ??s (2 million cells per kg. of body weight intravenously (IV) on<br>day 1 and day 3) along with standard treatment as per the study site treatment protocols.<br><br>Control Intervention1: Control Arm: In phase-1, there is no control group.<br>In phase-2, the patients in the control group will receive standard of<br>care (SOC) only.<br>Control Intervention2: Control Arm: Standard of Care<br> | 1. Proportion of participants experiencing Treatment-Emergent Adverse Events (TEAE). <br/ ><br>2. 28-day mortality <br/ ><br>Timepoint: 1. Proportion of participants experiencing Treatment-Emergent Adverse Events (TEAE) during 28 days of study. <br/ ><br>2. Percent mortality 28 days after drug administration <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/09/036646 | 8 November 2021 | Analysis of Economic Burden on COVID-19 Patients | Assessment of Clinical Presentations and Cost of Illness for COVID-19 Patients in a Charitable Hospital - NIL | | NIL | 20-09-2021 | 20210920 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60671 | Not Recruiting | No | | | | 26-09-2021 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Major Dr Shivakumar Hiremath | | Justice K S Hegde Charitable Hospital,
Deralakatte, Mangaluru Deralakatte, Mangaluru | udayvenkatmateti@gmail.com | 8152977460 | NGSM Institute of Pharmaceutical Sciences, Nitte Deemed to be University | Inclusion criteria: Patients diagnosed with COVID-19 positive <br/ ><br>COVID-19 patients with comorbidities <br/ ><br>COVID-19 patients admitted in the hospital from March 2020 to April 2021 <br/ ><br> | Exclusion criteria: Patients with incomplete records <br/ ><br>Pregnant patients <br/ ><br>Patients referred to other hospitals <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | Economic Burden on the patients suffering from COVID-19Timepoint: Single point | | | | Yes | False | | |
| +++ | CTRI/2021/09/036649 | 8 November 2021 | Role of yoga in improving cognitive function, reducing anxiety and depression due to COVID 19 in school children | Effect of Yoga in alleviating impaired cognitive function, anxiety and depression due to COVID 19 among school children aged between 13 to 17 years: A randomized control trial | | Sant Hirdaram medical college of naturopathy and yogic sciences for women Bhopal | 20-09-2021 | 20210920 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60747 | Not Recruiting | No | | | | 14-10-2021 | 400 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2 | India | Dr Pradeep MK Nair | | Department of research
Room number BS 22
Sant Hirdaram medical college of naturopathy and yogic science for women Sant Hirdaram Nagar Bhopal Sant Hirdaram medical college of naturopathy and yogic science for women | drpradeep18bnys@gmail.com | 9823262179 | Sant hirdaram medical college of naturopathy and yogic sciences for women Bhopal | Inclusion criteria: School children aged 13to 17 years <br/ ><br>Willing to participate in the study after the consent from their parents or legal guardian <br/ ><br>No history of any illness for at least six months before the study <br/ ><br> <br/ ><br> | Exclusion criteria: Children below the age of 13 and over the age of 17 years <br/ ><br>Unwilling participants and the ones could not comprehend and follow the instructions given by the instructor will excluded. <br/ ><br>Physical disability <br/ ><br>Under Psychiatric medications <br/ ><br>Known case of psychological disorder or psychiatric illness <br/ ><br>Recent surgery <br/ ><br>Obese and underweight participants <br/ ><br> | | Intervention1: Yoga: Suryanamaskar 5 rounds, breathing exercise, padahastasana, ardhchakrasana,vajrasana, shaskasana, ustrasana, nadi shodhan pranayama, bhramari pranayama, Om chanting and deep relaxation technique be practiced under supervision.<br>The therapy will be provided for 45 minutes for 5 days a week for 2 months.<br>Control Intervention1: NIL: NIL<br> | Cognitive function assessed by Trial Making TestTimepoint: Cognitive function will be assessed at baseline before the intervention i.e. Day 1 and Day 60 (at the end of two months intervention). | | | | Yes | False | | |
| +++ | CTRI/2021/09/036666 | 8 November 2021 | Impact of covid19 lockdown on health, and quality of life in people with disabilities | Impact of covid19 lockdown on physical functioning, health, and quality of life of people with locomotor disabilities | | Sancheti Institute college of Physiotherapy | 20-09-2021 | 20210920 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60571 | Not Recruiting | No | | | | 01-10-2021 | 180 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Apurv Shimpi | | Sancheti Institute college of Physiotherapy, thube park Shivaji Nagar, Pune 411005
Community Department,3rd floor,1st classroom | apurv008@gmail.com | 9890183195 | Sancheti college of Physiotherapy | Inclusion criteria: -1. Persons with locomotor disabilities (chronic stroke, <br/ ><br>extreme deformity with advanced age, poliomyelitis, amputations) suffering from disability before the lockdown <br/ ><br>2.Persons able to understand, read and interpret the document | Exclusion criteria: 1.People having a history of covid <br/ ><br>19 2.People not willing to participate | | | SF36 questionnaireTimepoint: 15 mins | | | | Yes | False | | |
| +++ | CTRI/2021/09/036732 | 8 November 2021 | â??Pregnancy Tele Yoga Moduleâ?? on stress, anxiety or depression of pregnancy during COVID-19 | Effectiveness of â??Pregnancy Tele Yoga Moduleâ?? on stress, anxiety or depression during COVID-19 Pandemic: a prospective, multi-centre, open-label single-arm exploratory study. | | Department of Science and Technology | 22-09-2021 | 20210922 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60844 | Not Recruiting | No | | | | 04-10-2021 | 120 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Sundarnag Ganjekar | | Department of Psychiatry
National Institute of Mental Health and Neuro Sciences | sundarnag@nimhans.ac.in | 9686976128 | National Institute of Mental Health and Neuro Sciences | Inclusion criteria: 1. Pregnant mothers in late second or early third trimester. <br/ ><br>2. Receiving ANC care at the study center. <br/ ><br>3. Planning their delivery at the study center. <br/ ><br>4. DASS-21 score: 10 - 27 on depression subscale, OR 8 - 19 on anxiety subscale OR 15 - 33 on stress subscale. <br/ ><br>5. Aged between 18 â?? 35 years. <br/ ><br>6. Clinical decision by treating obstetrician as a pregnant mother is physically fit for yoga intervention <br/ ><br>7. Providing informed consent. <br/ ><br> | Exclusion criteria: 1. Past history of psychiatric illness. <br/ ><br>2. DASS score â?¥ 28 on depression, â?¥ 20 on anxiety or â?¥ 34 on stress. <br/ ><br>3. Expressing suicidal thoughts/ideation or attempts in the last 1 week. <br/ ><br>4. Having any high-risk obstetric conditions based on obstetricianâ??s clinical assessment making participation in yoga-based exercise program difficult like placenta previa, multiple pregnancy, pre-eclampsia/eclampsia, poorly controlled gestational diabetes on insulin, pregnancy from in vitro fertilization, fetal abnormality on ultrasound scanning in current pregnancy, history of intrauterine growth restriction/multiple pregnancy losses in previous pregnancy. <br/ ><br> | Health Condition 1: F439- Reaction to severe stress, unspecified
Health Condition 2: F39- Unspecified mood [affective] disorder
| Intervention1: Pregnancy Tele Yoga Module: Yoga module for stress reduction in Pregnancy is adopted from the study published by Satyapriya M, Nagendra HR, Nagarathna R, Padmalatha V. Effect of integrated yoga on stress and heart rate variability in pregnant women. International Journal of Gynecology & Obstetrics. 2009 Mar 1;104(3):218-22.]. Participating pregnant mothers in their late 2nd trimester will be shown the Pregnancy Tele Yoga through an online platform. Through online platform, their performance will be monitored by the trained yoga staff. Pregnant mothers will be encouraged to practice yoga at least 1 hour per day 5 days a week for 4weeks<br><br>Control Intervention1: NIL: NIL<br> | This study will assess maternal stress, anxiety and depression among pregnant women during their late 2nd or early 3rd trimesters at the time of COVID 19 pandemic in India. <br/ ><br>The feasibility of tele (online platform) of â??Pregnancy Yoga Moduleâ?? among those who experience stress, anxiety and depression during pregnancy. <br/ ><br>The number of tele (online platform) sessions of â??Pregnancy Yoga Moduleâ?? the pregnant mothers can attend during the study period. <br/ ><br>The changes in the stress, anxiety and depression scores after 4 weeks of participation in â??Pregnancy Yoga Moduleâ??. <br/ ><br>The association between the number of â??Pregnancy Yoga moduleâ?? sessions attended and changes in the stress, anxiety and depression scores. <br/ ><br>The changes in the stress, anxiety and depression scores at 6 weeks postpartum after 4 weeks of participation in the â??Pregnancy Yoga Moduleâ??.Timepoint: acceptability and feasibility of pregnancy tele yoga at the end of 4 weeks | | | | Yes | False | | |
| +++ | CTRI/2021/09/036737 | 8 November 2021 | EFFECT OF TELE-YOGA ON PERCEIVED STRESS IN COVID-19 PATIENTS DUE TO QUARANTINE. | â??EFFICACY OF TELE-YOGA ON PERCEIVED STRESS DUE TO QUARANTINE DURING COVID-19: A PROSPECTIVE, MULTICENTRE, OPEN-LABEL SINGLE-ARM EXPLORATORY STUDYâ?? | | DST SATYAM Government of India | 22-09-2021 | 20210922 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60243 | Not Recruiting | No | | | | 01-10-2021 | 262 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Hemant Bhargav | | Room Number:003,Department of Integrative Medicine, National Institute of Mental Health and Neuro Sciences NIMHANS, Hosur main raod,Bangalore India | padmavati@scarfindia.org | 914426153971 | Schizophrenia Research Foundation | Inclusion criteria: The people who have been diagnosed with COVID-19 currently or have suffered from the same anytime past one year. In addition, individuals should report atleast a moderate level of psychological stress (i.e., a score of 8 or greater) using four items from the Perceived Stress Scale (PSS). | Exclusion criteria: Exclusion from participation will be made for anyone practicing yoga or meditation in the past year, or if there are known physical limitations preventing light physical activity (yoga postures). Subjects with severe covid-19 symptoms that would affect the practice of prescribed tele-yoga programme. Subjects with other medical illnesses that would prevent the practice of prescribed tele-yoga programme. Individuals with comorbid suicidal ideation, self-harm risk, or psychosis or any other severe mental illness will also be excluded. | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Tele-Yoga Program (TYP)<br>Single-arm multi centric study.: The intervention will comprise of a 45-minute validated Tele-Yoga Program (TYP) being taught by a trained yoga teacher at each site through a videoconferencing facility â?? to a group of 10 participants at a time for five times a week for the first 4 weeks followed by three times a week for next 12weeks.Subjects will be<br>encouraged to practice on their own, every day, in the last 12 weeks. Total number ofsessions:20 supervised<br>sessions in the first month, and12 sessions per month for the next 3 months.<br>Control Intervention1: not applicable: not applicable<br>Control Intervention2: not applicable: not applicable<br> | The primary outcome for assessing the clinical effectiveness of the yoga intervention is the change in psychological stress scores. The perceived stress scale (PSS) (Cohen et al., 1983) will be used for assessment of psychological stress.Timepoint: T1-Baseline <br/ ><br>T2-Fourth week <br/ ><br>T3-16th week after the intervention Primary effectiveness outcome. A baseline, Fourth week, and 16 weeks for all the subjects for relevant assessments | | | | Yes | False | | |
| +++ | CTRI/2021/09/036781 | 8 November 2021 | Clinical trial to determine safety and efficacy of intravenous silver nanoparticles in severe covid patients | Assessing Efficacy and Applicability of Intravenous Water Dissolved Silver Nanoparticles as a Novel Adjuvant in the Treatment of Severe SARS CoV2 Identified Pneumonia in Elderly patients â?? An Investigator Initiated Study (IIS). | | Dr Subhasish Sarkar | 23-09-2021 | 20210923 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60830 | Not Recruiting | No | | | | 04-10-2021 | 40 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India | Dr Subhasish Sarkar | | Room No 02, 2nd Floor, Department of General Surgery, College of Medicine and Sagore Dutta Hospital, Kamarhati, Kolkata, West Bengal 700058. | s.sarkar735@gmail.com | 9564524882 | College of Medicine and Sagore Dutta Hospital | Inclusion criteria: 1. RT-PCR Confirmed COVID 19 patients of either sex <br/ ><br>2. Age greater than 18 years <br/ ><br>3. EWS score 5 and above <br/ ><br>4. Clinically diagnosed moderately severe and severe pneumonia <br/ ><br>5. Willing to participate in the trial. | Exclusion criteria: 1. Patients with EWS score below 5 <br/ ><br>2. Not Willing to participate in the trial | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Intravenous Silver Nanoparticles- AgSept manufactured by BHS medical solutions GmbH Germany) in addition to standard therapy: Treatment duration is 5 days.<br>Control Intervention1: Standard Therapy: Standard Therapy as per Hospital Protocol.<br> | Determining the efficacy of intravenous Silver Nanoparticles (AgSept) in addition to standard therapy for treating moderately severe and severe COVID pneumonia patients with or without co-morbidities of elderly age group in terms of hemodynamic stability, oxygen requirement, duration of hospital stay and mortality prevention.Timepoint: Day 1, Day 3, Day 5 and Day 10 | | | | Yes | False | | |
| +++ | CTRI/2021/09/036786 | 8 November 2021 | Clinical Trial to Evaluate the Efficacy and Safety of Tablets of Purified Aqueous Extract of Cocculus hirsutus in Treatment of Mild COVID-19 Disease | A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Adaptive Clinical Trial to Evaluate the Efficacy and Safety of Tablets of Purified Aqueous Extract of Cocculus hirsutus in Treatment of Mild COVID-19 Disease | | Sun Pharmaceutical Industries Limited | 23-09-2021 | 20210923 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60937 | Not Recruiting | No | | | | 30-09-2021 | 798 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Double Blind Double Dummy | Phase 2/ Phase 3 | India | Nilesh R Kadam | | Sun Pharma Laboratories Limited,
Sun House, Plot No. 201 B/1, Western Express Highway, Goregaon ( E),
Mumbai - 400 063, Maharashtra, India
| sapan.behera@sunpharma.com | 02243244324 | Sun Pharma Laboratories Limited | Inclusion criteria: 1. Male or non-pregnant, non-lactating female patient aged more than or equal to 18 years of age <br/ ><br>2. Patients with laboratory confirmed COVID-19 disease by SARS-CoV-2 positive RT-PCR test (within 48 hours prior to enrollment) <br/ ><br>3. Patients who had initial onset of signs/symptoms attributable to COVID-19 disease for less than or equal to 5 days prior to the day of randomization <br/ ><br>4. Patients who had fever more than or equal to 100.4ºF (oral or axillary temperature) within last 5 days and have at least one of the following respiratory symptoms attributable to COVID-19 disease: cough, runny nose, and sore throat <br/ ><br>5. Patients with SpO2 more than or equal to 95% and respiratory rate less than or equal to 20 breaths/minute <br/ ><br>6. Patients who have at least one of the following high-risk factors: Age more than 60 years, BMI more than 27 kg/m2, Hypertension (Patients with SBP 140 to 200 mm Hg and/or DBP 90 to 110 mm Hg OR on anti-hypertensive medication), T2DM (Patients with confirmed diagnosis of T2DM with FBG more than or equal to 126 mg/dL or PPBG more than or equal to 200 mg/dL OR on anti-diabetic medication), Bronchial Asthma (Patients with documented diagnosis of Bronchial Asthma since at least one year prior to screening), COPD (Patients with documented diagnosis of COPD since at least one year prior to screening) <br/ ><br>7. Patient who provides written/electronic informed consent and agrees to comply with study procedures <br/ ><br>8. Women of childbearing potential must have a negative urine pregnancy test prior to study entry and agree to use highly effective methods of contraception to prevent pregnancy from study entry till at least two weeks after the last dose of the study medication (such contraception may include hormonal birth control e.g., combined estrogen and progestogen containing [oral, intravaginal, or transdermal] or progesterone only [oral, injectable, or implantable] hormonal contraception associated with inhibition of ovulation, intrauterine devices, intrauterine hormone releasing system OR bilateral tubal occlusion, vasectomized partner, or total sexual abstinence) <br/ ><br>[Note: Women with childbearing potential are defined as: those who are not (1) surgically sterile (bilateral oophorectomy, hysterectomy, or bilateral tubal ligation) or (2) post-menopausal. Post-menopausal woman will be defined as: Woman not using hormonal replacement therapy and have had at least 12 continuous months of natural (spontaneous) amenorrhea and be greater than 45 years of age.]. <br/ ><br> | Exclusion criteria: 1. Patients with moderate to severe COVID-19 disease at randomization <br/ ><br>2. Patients with known active hepatitis, tuberculosis, and definite bacterial or fungal infections <br/ ><br>3. Patients with inability to take or tolerate oral medications <br/ ><br>4. Patients requiring ICU monitoring and the treatment <br/ ><br>5. Patients who have received one or two doses of vaccine for COVID-19 disease <br/ ><br>6. Patients with AST or ALT more than 3 times ULN <br/ ><br>7. Patients on dialysis or has reduced eGFR less than 30 mL/min/1.73 m2 (by the MDRD equation) <br/ ><br>8. Patients with prolonged QTc-interval at baseline ECG (more than 450 ms in males or more than 470 ms in females) <br/ ><br>9. Patients with history of hypersensitivity towards any drug of SOC <br/ ><br>10. Patient has any condition for which, in the opinion of the Investigator, participation would not be in the best interest of the patientâ??s safety or any other circumstances that prevent the patient from participating in the study <br/ ><br>11. Patients with conditions that could limit gastrointestinal absorption of drug <br/ ><br>12. Patients with history of serology tests positive for hepatitis B, hepatitis C, or human immunodeficiency virus. <br/ ><br>13. Patients who have received other antiviral drugs such as favipiravir or remdesivir, monoclonal antibodies or corticosteroids within 5 days prior to randomization <br/ ><br>14. Patients who had participated in another investigational study within 3 months prior to enrolment in this study. <br/ ><br>15. Investigators, study personnel, Sponsorâ??s representatives and their first-degree relatives <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Purified aqueous extract of Cocculus hirsutus (AQCH) tablets: Two tablets of 300 mg Orally, TID (every 8±1 hours) at least 30 minutes before meals preferably at the same time every day for 10 days.<br>Patient will also be given standard of care in accordance with Current Clinical Guidance for<br>Management of Adult COVID-19 Patients, released by AIIMS/ICMR-COVID-19 National Task Force and<br>Joint Monitoring Group (DGHS) - MOHFW guidelines dated 17th May 2021.<br>Control Intervention1: Matching placebo tablets: Two tablets of 300 mg Orally, TID (every 8±1 hours) at least 30 minutes before meals preferably at the same time every day for 10 days. Patient will also be given standard of care in accordance with Current Clinical Guidance for Management of Adult COVID-19 Patients, released by AIIMS/ICMR-COVID-19 National Task Force and Joint Monitoring Group (DGHS) - MOHFW guidelines dated 17th May 2021.<br> | Proportion of patients who progress in COVID-19 disease severity from â??Mild diseaseâ?? to â??Moderate or Severe diseaseâ??Timepoint: Time frame: up to Day 14 <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/09/036820 | 8 November 2021 | Leisure participation of Southern India University students following the Covid-19 pandemic | Experiences regarding Leisure Participation among Southern India University Students following the onset of the Covid-19 pandemic: A qualitative study | | Nguyen Huynh Ngoc Mai Tram | 24-09-2021 | 20210924 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60177 | Not Recruiting | No | | | | 01-10-2021 | 12 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | N/A | India | Nguyen Huynh Ngoc Mai Tram | | Department of Occupational Therapy, 3rd floor, Manipal College of Health Professions, Madhav Nagar, Eshwar Nagar | vinita.acharya@manipal.edu | 9986071111 | Manipal College of Health Professions | Inclusion criteria: University students, age 18 to 25 years old, who experience more than one year on a university campus, and have leisure participation both before and after the onset of the pandemic. | Exclusion criteria: Individuals with physical disability or sustained COVID-19 infection will be excluded | | | To explore experiences related to leisure participation among university students following the onset of the COVID-19 pandemic using thematic analysis for in-depth interviewTimepoint: At baseline | | | | Yes | False | | |
| +++ | CTRI/2021/09/036826 | 8 November 2021 | A study on the efficacy of Tulasi-Ashwagandhadi Herbal Drops on Oxygen Saturation (SPO2) in the management of COVID-19 affected cases. | A double blinded randomized controlled clinical study to evaluate the efficacy of the Tulasi Ashwagandhadi Herbal Drops on Oxygen Saturation (SPO2) in the management of COVID-19 affected cases. | | Charak Hanf Pvt Ltd | 24-09-2021 | 20210924 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60504 | Not Recruiting | No | | | | 11-10-2021 | 110 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded | Phase 2 | India | Dr Geetha M B | | Department of PG Studies in Roga Nidana Alvas Ayurveda Medical College Moodbdiri | directoratmarc@gmail.com | 9448006199 | Alvas Ayurveda Medical College | Inclusion criteria: Male or female subjects who have been found to be COVID-19 positive <br/ ><br>The Oxygen Concentration level (SpO2) is between 85-95% observable during baseline screening. <br/ ><br>Subjects in the age group 18-65 years (both the ages inclusive). <br/ ><br>Subjects willing to give a written informed consent and agree to come for a regular follow up visit. <br/ ><br>Subjects with mild to moderate level of symptoms pertaining to COVID-19 <br/ ><br>Subjects willing to abide by and comply with the study protocol. <br/ ><br>Subjects who have not participated in a similar investigation in the past three months. | Exclusion criteria: Subjects who have undergone invasive treatments like surgery or other treatment within 3 months before screening into the study. <br/ ><br>Subjects having any active disease which may interfere in the study. <br/ ><br>Any history of underlying uncontrolled medical illness including diabetes mellitus, hypertension, HIV, hepatitis, severe anemia, serious disorder of heart and respiratory apparatus or any other serious medical illness. <br/ ><br>Subjects who have taken chemotherapy for cancer in the 6 months prior to start of the study or have a plan to do treatments during study. <br/ ><br>Subjects (females) who are pregnant or lactating <br/ ><br>A known history or present condition of allergic response/hypersensitivity to any ingredients and pharmaceutical products. <br/ ><br>Chronic illness which may influence the respiratory state. <br/ ><br>Subjects who had been part of any other clinical study within 3 months before screening into the study. | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | To study the efficacy of Test product in elevation of SpO2 Concentration over Treatment Phase and Followup Phase in comparison to BaselineTimepoint: Baseline, Day1, Day4, Day7, Day14 and Day21 | | | | Yes | False | | |
| +++ | CTRI/2021/09/036828 | 8 November 2021 | A study of Ampion in adults with respiratory distress due to COVID-19.
| A Randomized, Double-Blinded, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of Inhaled Ampion in Adults with Respiratory Distress due to COVID-19. - AP019 | | Ampio Pharmaceuticals Inc | 24-09-2021 | 20210924 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61016 | Not Recruiting | No | | | | 16-10-2021 | 200 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant and Investigator Blinded | Phase 2 | India;United States of America | Mr Gajendrasinh Chanchu | | QED Clinical Services India Private Limited
Clinical Operations
Office number B-209, Westgate, Besides YMCA Club
S. G. Highway
Ahmadabad
GUJARAT
India | bgupta@orphan-reach.com | | Department of Clinical Operation | Inclusion criteria: 1. Male or female, â?¥ 18 years old <br/ ><br>2. Diagnosed with SARS-CoV2, as confirmed using a standard RT-PCT assay or an equivalent test. <br/ ><br>3. Baseline severity categorization of severe or critical COVID-19 infection per FDA Guidance for developing drugs and biological products for COVID-19 (February 2021): <br/ ><br>a) Severe COVID-19: <br/ ><br>â?¢ Symptoms suggestive of severe systemic illness with COVID-19, which could include shortness of breath or respiratory distress. <br/ ><br>â?¢ Clinical signs indicative of severe systemic illness with COVID-19, such as respiratory rate â?¥ 30 per minute, heart rate â?¥ 125 per minute, SpO2 â?¤ 93% on room air at or PaO2/FiO2 < 300. <br/ ><br> <br/ ><br>b) Critical COVID-19: <br/ ><br>â?¢ Oxygen delivered by high-flow nasal cannula (heated, humidified, oxygen delivered <br/ ><br>â?¢ Non-invasive mechanical or endotracheal mechanical ventilation via reinforced cannula at flow rates > 20 L/min with fraction of oxygen â?¥ 0.5) <br/ ><br> <br/ ><br>4. Informed consent obtained from the patient or the patients legal representative <br/ ><br> | Exclusion criteria: 1.As a result of the medical review and screening investigation, the Principal Investigator considers the patient unfit for the study and/or progression to death is imminent and inevitable irrespective of the provision of treatments. <br/ ><br>2. Clinical diagnosis of respiratory failure requiring ECMO and/or therapy is not available due to limitation. <br/ ><br>3. Shock defined by systolic blood pressure <90 mm Hg, or diastolic blood pressure <60 mm Hg or requiring vasopressors. <br/ ><br>4. Multi-organ dysfunction/failure. <br/ ><br>5. Patient has severe chronic obstructive or restrictive pulmonary disease (COPD) (as defined by prior pulmonary function tests), chronic renal failure, or significant liver abnormality (e.g., cirrhosis, transplant, etc.). <br/ ><br>6. Patient has chronic conditions requiring chemotherapy or immunosuppressive medication <br/ ><br>7.A history of allergic reactions to human albumin (reaction to non-human albumin such as egg albumin is not an exclusion criterion) or ingredients in 5% human albumin (N- acetyltryptophan, sodium caprylate). <br/ ><br>8. Prolonged QT interval. <br/ ><br>9. Patient has known pregnancy or is currently breastfeeding. <br/ ><br>10. Patient planning to become pregnant, or father a child, during the treatment and follow-up period and/or is not willing to remain abstinent or use contraception. <br/ ><br>11. Participation in another clinical trial (not including treatments for COVID-19 as approved by the FDA through expanded access, emergency, or compassionate use), or participation in a trial such that enrollment in this study would fall within the time frame of the half-life of the other investigational product(s). <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Ampion: Participants in the active arm will inhale nebulized Ampion (8 mL) administered four times daily for 5 days. Nebulized drug will be delivered using the Aerogen Solo Nebulizer System with the Aerogen Solo Adaptor (FDA 510K K133360) manufactured by Aerogen Limited, Galway, Ireland.<br>Control Intervention1: Placebo: Participants in the control arm will inhale nebulized placebo (8 mL) administered four times daily for 5 days. Nebulized placebo will be delivered using the Aerogen Solo Nebulizer System with the Aerogen Solo Adaptor (FDA 510K K133360) manufactured by Aerogen Limited, Galway, Ireland.<br> | Percentage of participants with a successful outcome (life) or unsuccessful outcome (death) by Day 28.Timepoint: To be assessed by Day 28 | | | | Yes | False | | |
| +++ | CTRI/2021/09/036829 | 8 November 2021 | Yoga for lung functions in COVID-19 survivors | Effect of Yoga-based Rehabilitation on pulmonary function in COVID-19 survivors with respiratory sequelae: A PROBE trial - Re-Cover | | All India Institute of Medical Sciences | 24-09-2021 | 20210924 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59905 | Not Recruiting | No | | | | 30-11-2021 | 104 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | Phase 2 | India | Randeep Guleria | | Director Office, AIIMS, New Delhi Director Office, AIIMS, New Delhi | randeepguleria2002@yahoo.com | 9810184738 | AIIMS, New Delhi | Inclusion criteria: a)Known case of COVID patients with respiratory symptoms on screening (RT-PCR negative or 4 weeks to 8 weeks from the onset of first symptom) <br/ ><br>b)Patients with forced vital capacity(FVC) <80% <br/ ><br>c)Patients of both sex and age of18-75years <br/ ><br>d)Patients who are able and willing to practice any form of exercise when recruited under the study <br/ ><br>e)Patients who are not engaged in regular and structured yoga practice. <br/ ><br> | Exclusion criteria: a)Patients with forced vital capacity FVC <40 % <br/ ><br>b)Previous pulmonary complications like severe asthma, COPD, bronchiectasis, interstitial lung disease(IL) <br/ ><br>c)Known cases of CAD with moderate to severe LV dysfunction, patients with a history of CV or neurodegenerative diseases. <br/ ><br>d)Lactating and pregnant women. <br/ ><br>e)Patients currently participating in any other clinical trials with intervention. | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Yoga Based Rehabilitation including loosening exercises, breathing exercises, asanas, pranayama and guided relaxation: First 3 sessions will be contact session with in the first week of recruitment at CIMR following online session, twice a week for12 weeks.<br>Control Intervention1: Standard Care: Standard care provided by the treating physican at AIIMS, New Delhi<br> | Pulmonary Function: Diffusion lung capacity for carbon monoxide (DLCO), Forced Vital capacity (FVC), Forced expiratory volume in first second (FEV1), Total lung capacity (TLC) using Pulmonary function testTimepoint: Baseline, after 6 weeks and at the end of 12 weeks | | | | Yes | False | | |
| +++ | CTRI/2021/09/036830 | 8 November 2021 | A bridging study to evaluate immunogenicity and safety of single dose of Sputnik Light in Indian adults and elderly for prevention of SARS-CoV-2 Infection | Phase III, open label, un-controlled, multicenter, bridging study to evaluate immunogenicity and safety of single dose of Sputnik Light in Indian adults and elderly for prevention of SARS-CoV-2 Infection | | Dr Reddys Laboratories Limited | 24-09-2021 | 20210924 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60333 | Not Recruiting | No | | | | 29-09-2021 | 179 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India | Dr Jayashri Krishnan | | Tower 2, 1st Floor, South Wing, L&T Business Park, Plot no 12/4 , Sector 27 D, Near Sarai Khawaja Metro Station, Delhi Mathura Road, Faridabad -121003, Haryana, India | sonika.newar@jssresearch.com | 8800799887 | JSS Medical Research Asia Pacific Private Limited | Inclusion criteria: Subjects will be enrolled in the study if they meet all the following criteria. <br/ ><br> <br/ ><br>1.Ability to provide written informed consent and Willingness to participate in the study <br/ ><br> <br/ ><br>2.Participants of either gender of age of more than â?¥18 years to <99 years <br/ ><br> <br/ ><br>3.Negative COVID-19 RT-PCR test result at the screening visit (within 96 hours prior to Visit 1 [Day 1]). and negative IgM SARS specific antibodies at the screening visit <br/ ><br> <br/ ><br>4.No medical history of COVID-19 in last 90 days <br/ ><br> <br/ ><br>5.Consent for using effective methods of contraception during the entire trial and 3 months after its completion <br/ ><br> <br/ ><br>6.No history of any vaccine-induced reactions or complications after receiving immunobiological products <br/ ><br> <br/ ><br>7.No history of acute infection and/or respiratory diseases within at least 14 days before the enrollment <br/ ><br> | Exclusion criteria: Subjects will be entered into the study only if they meet none of the following criteria. <br/ ><br> <br/ ><br>1.Any vaccination/immunization within 30 days before the enrolment <br/ ><br> <br/ ><br>2.Any vaccination/immunization against COVID 19 before the enrolment <br/ ><br> <br/ ><br>3.Any ongoing systemic steroids (except hormonal contraceptives) and/or immunoglobulins or other blood products in the last 30 days before the enrolment <br/ ><br> <br/ ><br>4.On Immunosuppressive therapy within 3 months of the enrolment <br/ ><br> <br/ ><br>5.Neutropenia (absolute neutrophil count <1,000 mm3),severe anemia (hemoglobin <80 g/L), in screening test <br/ ><br> <br/ ><br>6.Immunodeficiency or autoimmune disorders in the medical history within 6 months before the enrolment <br/ ><br> <br/ ><br>7.Pregnancy or breast-feeding <br/ ><br> <br/ ><br>8.Acute coronary syndrome or stroke in the last one year before the enrolment <br/ ><br> <br/ ><br>9.Active Tuberculosis or any other ongoing chronic systemic <br/ ><br>infections <br/ ><br> <br/ ><br>10.Anorexia, or protein deficiency of any origin <br/ ><br> <br/ ><br>11.Tattoos at the injection site (deltoid muscle area), which does not allow assessing the local response to the IMP administration <br/ ><br> <br/ ><br>12.Alcohol or drug addiction in the medical history <br/ ><br> <br/ ><br>13.Participation in any other interventional clinical trial within 90 days prior to the Screening <br/ ><br> <br/ ><br>14.Any other medical condition that would limit the participation of the subject as per Investigatorâ??s discretion <br/ ><br> <br/ ><br>15.HIV, hepatitis B or C infection <br/ ><br> <br/ ><br>16.Medical history of malignancy <br/ ><br> <br/ ><br>17.Splenectomy in the medical history <br/ ><br> <br/ ><br>18.Subjects contraindicated for vaccination <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Sputnik Light: Recombinant adenovirus serotype 26 particles containing the SARS-CoV-2 protein S gene, in the amount of (1.0±0.5) Ñ?1011 particles per dose (Component 1 of Gam COVID-VAC Vaccine i.e. Sputnik V)<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br> | GMT for SARS-CoV-2 glycoprotein specific antibody on days 42, 90 & 180.Timepoint: Days 42, 90 & 180. | | | | Yes | False | | |
| +++ | CTRI/2021/09/036831 | 8 November 2021 | How much does the diabetes increase the severity of COVID -19 infection in pregnancy compared to people without Diabetes ? | Does Diabetes alter the severity of COVID-19 infection in Pregnancy ? | | Dr Simi Kurian | 24-09-2021 | 20210924 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61013 | Not Recruiting | No | | | | 04-10-2021 | 800 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Simi Kurian | | Room 405 , fourth floor
Department of Obstetrics and Gynecology
Government Medical College ,Kannur,Pariyaram
Kerala | drsimikurian@gmail.com | 8156991384 | Government Medical College Kannur,kerala | Inclusion criteria: Patients admitted to the study centre with pregnancy and lab-confirmed COVID -19 infection during the study period | Exclusion criteria: patients transferred to other centres or discharged against medical advice | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | To determine the risk of severe infection with COVID-19 in pregnancy in patients with Diabetes compared to those without DiabetesTimepoint: 1 year (from August 1 ,2020 to July 31,2021) | | | | Yes | False | | |
| +++ | CTRI/2021/09/036832 | 8 November 2021 | Evaluation for the risk of allergy to COVID-19 vaccines in people with history of allergy diathesis. | Evaluation for the risk of allergy to COVID-19 vaccines in people with history of allergy diathesis. | | ICMR | 24-09-2021 | 20210924 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60987 | Not Recruiting | No | | | | 11-10-2021 | 100 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Dhruve Soni | | Department of Clinical Pharmacology, 1st floor New MS Building Seth GSMC and KEM Hospital ,Parel, Mumbai-400012 | sonidhruve@gmail.com | 8894411660 | Seth GS Medical College & KEM Hospital, Parel, Mumbai-400012 | Inclusion criteria: Participants with history of anaphylaxis or allergic reaction or any allergies. <br/ ><br>Participants who are yet unvaccinated to COVID-19 vaccine. <br/ ><br>Participants who are due for 2nd dose of COVID-19 vaccine, with history of reaction to the first dose <br/ ><br>Patients with history of idiopathic anaphylaxis. <br/ ><br>Participant of either gender of more than 18 years <br/ ><br>Participants who are able to provide a written informed consent or have a legally accepted representative [LAR] to provide the same. <br/ ><br> | Exclusion criteria: Participants who have taken both doses COVISHIELD vaccine. <br/ ><br>Participants who are participating in any other clinical trial or experimental treatment for COVID-19. <br/ ><br>Participants who are not deemed fit as per the investigator or his/her team for any other medical reason. <br/ ><br>Female participants who are pregnant or lactating. <br/ ><br> | Health Condition 1: T784- Other and unspecified allergy
| Intervention1: Skin test (Skin prick test and intradermal test) for the assessment of allergic response to COVISHIELD vaccine.: Skin test (Skin prick test and intradermal test) will be performed for the assessment of allergic response to COVISHIELD vaccine by senior allergy consultant under the supervision of a senior anaesthetist and intensivist in phase one unit of Seth GS Medical College and KEM Hospital, Mumbai.<br><br>The First step is Skin prick test with full concentration of COVISHIELD vaccine and Polysorbate 80 (excipient used in COVISHIELD a derivative of Polyethylene glycol can be possible culprit for allergic reaction) followed by intradermal test with 1:100 dilution (Step-2), 1:10 dilution (Step-3), 1:1 dilution (Step-4) of COVISHIELD and Polysorbate 80.<br><br>All steps will be carried out in fifteen minutes interval if no reaction occurs. The testing will be stopped if a positive reaction occurs at any step.<br><br>Based on the result of skin test, after clinical assessment from allergy consultant and risk of allergy as per history, participants will be advised to get full dose or split dose of COVISHIELD vaccine.<br> <br>In split dose schedule 0.1 ml of COVISHIELD will be given first followed by 30 minutes of observation and if no reaction occurs remaining of 0.4 ml of vaccine will be administered and the participant again observed for 30 minutes.<br><br><br>Control Intervention1: Not Applicable: Not Applicable<br> | Proportion of participants with negative skin test with both COVISHIELD vaccine and Polysorbate 80 among the total number of participants. <br/ ><br>Proportion of participants with negative skin test with COVISHIELD vaccine and positive with Polysorbate 80 among the total number of participants.Timepoint: Day Zero | | | | Yes | False | | |
| +++ | CTRI/2021/09/036848 | 8 November 2021 | Impact of COVID-19 on renal transplantation patients | Impact of COVID-19 on renal transplantation patients | | Geethanjali Ganesan | 27-09-2021 | 20210927 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60943 | Not Recruiting | No | | | | 09-10-2021 | 22 | Observational | Other<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | N/A | India | Geethanjali Ganesan | | Department of Nephrology,
Sri Ramachandra Medical Centre, Porur Chennai | ramprasadnephro@gmail.com | 09894120150 | Sri Ramachandra Institute of Higher Education and Research | Inclusion criteria: Patients who have been diagnosed with COVID-19 with after undergoing renal transplantation , who were home quarantined or isolated in facility, have been considered for study. | Exclusion criteria: Patients who have undergone renal transplantation and tested negative for COVID-19. | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | Clinical and biochemical profile of COVID positive renal transplantation patientsTimepoint: 6 months | | | | Yes | False | | |
| +++ | CTRI/2021/09/036919 | 8 November 2021 | A survey on awareness about the pulse oximeter in the public in the light of COVID-19 pandemic | Awareness about The Pulse Oximeter in the Public: A Survey of Knowledge, Attitude and Practices in The Light of COVID 19 | | Dr Archana A Bharadwaj | 28-09-2021 | 20210928 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60930 | Not Recruiting | No | | | | 01-12-2021 | 400 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Archana A Bharadwaj | | Department of Anaesthesiology,
SDM Medical College and Hospital,
Shri Dharmasthala Manjunatheshwara University, Dharwad - 580009
| archana.a.b16@gmail.com | 9886468625 | SDM Medical College and Hospital, Shri Dharmasthala Manjunatheshwara University, | Inclusion criteria: all individuals who are willing to fill up the questionnaire. | Exclusion criteria: Refusal of consent, Age <18 years | | Intervention1: not applicable: not applicable<br> | the level of knowledge, attitude, and practices (KAP) with respect to pulse oximeter in the public in the light of COVID-19 pandemicTimepoint: Baseline | | | | Yes | False | | |
| +++ | CTRI/2021/09/036973 | 8 November 2021 | Study to Assess the Efficacy and Safety of BP08 (Tocilizumab) versus Actemra®/RoActemra® plus Standard of Care in Severe COVID-19 patients | A Randomized, Open-Label, Parallel Group Study to Compare Efficacy and Safety of BP08 plus Standard of Care versus Reference Biologic Tocilizumab (Actemra®/RoActemra®) plus Standard of Care in Patients with Severe COVID-19 Disease | | CURATEQ BIOLOGICS PRIVATE LIMITED India | 29-09-2021 | 20210929 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61134 | Not Recruiting | No | | | | 20-10-2021 | 66 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Open Label | Phase 2 | India | Dr Subhra Lahiri | | AXIS Clinicals Ltd
1 121 1 Miyapur Hyderabad500049
Telangana INDIA Associate Vice President
AXIS Clinicals Ltd
1 121 1 Miyapur Hyderabad500049
Telangana INDIA
| Subhra.L@axisclinicals.com | 914040408064 | AXIS Clinicals Ltd | Inclusion criteria: Subjects will be considered eligible when all the following criteria met: <br/ ><br>1. Male or female adult patients. 18 to 65 years of age (both inclusive). <br/ ><br>2. Hospitalized and Confirmed case of SARS-CoV-2 infection by rtPCR or rapid antigen test. <br/ ><br>3. Severe COVID19 disease as defined as (any one of below) <br/ ><br>o Respiratory rate >30/min, Breathlessness <br/ ><br>o SpO2 < 90% on room air or requiring Oxygen therapy. <br/ ><br>4. Patient shows no signs of improvement in terms of oxygen requirement even after 24-48 hours of administration of steroids as per hospital records. <br/ ><br>5. Evidence of systemic inflammation (any one of below) <br/ ><br>o CRP â?¥ 75mg/L. <br/ ><br>o IL-6 â?¥ 40 pg/mL <br/ ><br>6. Informed consent for participation in the study either by Patient or LAR | Exclusion criteria: 1. Known hypersensitivity to Tocilizumab or other monoclonal antibodies. <br/ ><br>2. Evidence of active tuberculosis infection <br/ ><br>3. Suspected or active bacterial, fungal, viral or other infection (Besides COVID-19) <br/ ><br>4. Patient on invasive mechanical ventilator <br/ ><br>5. In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments. <br/ ><br>6. Received prior treatment with oral anti-rejection or immune modulatory drugs (including Tocilizumab) within the previous 6 months. <br/ ><br>7. Received immunomodulatory or biologics therapy (except steroids) as standard of care for the treatment of COVID-19 which could impact primary of secondary objectives of the study (including but not limited to itolizumab and TNF alpha inhibitors) <br/ ><br>8. Patients with severe renal failure (eGFR < 30 mL/min) or on dialysis [eGFR should be calculated by using the Cockcroft-Gault formula] <br/ ><br>9. Any serious medical condition (including multiorgan failure) or abnormality of clinical laboratory tests that, in the investigatorâ??s judgment, precludes the patient safe participation in and completion of the study. <br/ ><br>10. Absolute Neutrophil count < 1000, platelet count < 100,000 per microliter at screening/baseline <br/ ><br>11. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times upper limit of normal detected at screening/baseline <br/ ><br>12. Participating in other drug clinical trials <br/ ><br>13. Pregnant or breastfeeding or positive pregnancy test in a pre-dose examination <br/ ><br>14. History or known case of Hepatitis B, C or HIV <br/ ><br>15. Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization. | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: BP08 Tocilizumab: 400 mg of BP08 in 20 mL (20 mg/mL)<br>Control Intervention1: Tocilizumab (Actemra®/RoActemra®): 400 mg of BP08 in 20 mL (20 mg/mL)<br> | Cumulative proportion of patients progressed by Day 28 (Progression is defined as requiring invasive mechanical ventilation, ECMO or met fatal outcome)Timepoint: Cumulative proportion of patients progressed by Day 28 | | | | Yes | False | | |
| +++ | CTRI/2021/09/036974 | 8 November 2021 | 6 minute walk test as an index to predict the recovery after abdominal surgeries in patients with past history of Covid-19 infection. | To assess preoperative six minute walk test as a predictor of quality of recovery after elective laparotomy surgery in post Covid-19 patients. | | Department of Anaesthesiology and Intensive Care | 29-09-2021 | 20210929 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58842 | Not Recruiting | No | | | | 05-10-2021 | 30 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Neelam Prasad | | Department of Anaesthesiology and Intensive Care,
B.L.Taneja Block,
Maulana Azad Medical College, Bahadur Shah Zafar Marg,
New Delhi.
India. | nprasadgovil@yahoo.com | 9968604372 | Maulana Azad Medical College | Inclusion criteria: 1. Patients who are recovered from Covid-19, undergoing elective laparotomy of expected duration of surgery within 3 hours. <br/ ><br>2. Patients having a history of Covid-19 infection at least 2 months back. <br/ ><br>3. Patients of ASA physical health status 1,2,3. <br/ ><br> | Exclusion criteria: 1. Patient with significant cardiac disease (low threshold angina, severer aortic stenosis). <br/ ><br>2. Patient with severe pulmonary disease restricting there mobility. <br/ ><br>3. Patient having condition that prevents mobilisation for upto six minutes. <br/ ><br>4. Pregnancy | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: O- Medical and Surgical
| | Prognostic value of 6 minute walk test to predict quality of recovery in patients recovered from COVID-19, undergoing elective laparotomy surgeries.Timepoint: 1. After 24 hours of surgery by follow up of patient bedside in ward. <br/ ><br>2. After 30 days of surgery. | | | | Yes | False | | |
| +++ | CTRI/2021/09/036975 | 8 November 2021 | Ophthalmic manifestations and
correlation with serum levels of VEGF-D in COVID-19 recovered subjects | Evaluation of ophthalmic manifestations and
correlation with serum level of Vascular endothelial growth factor-D in COVID-19 recovered subjects
| | ARCHANA T R | 29-09-2021 | 20210929 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58636 | Not Recruiting | No | | | | 10-10-2021 | 80 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India | Archana T R | | Postgraduate resident 2
Dr.Anju Unit
Guru Nanak Eye Center
Maharaja Ranjeet Singh Marg, LNJP Colony, New Delhi, Delhi 110002 | punitasodhi222@gmail.com | 9891373756 | Guru Nanak Eye Center | Inclusion criteria: who have recovered from SARS-CoV-2 diseases <br/ ><br> | Exclusion criteria: Subjects who had undergone any ocular or cranial surgery other than uneventful cataract surgery <br/ ><br> <br/ ><br>Subjects having pre-existing ocular pathology like retinal diseases, uveitis, media opacities and glaucoma; or central nervous system disease like tumors, demyelination, degeneration, etc. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: H00-H59- Diseases of the eye and adnexa
| | Serum Vascular Endothelial Growth Factor-D levels <br/ ><br>Timepoint: 1 year <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/10/037031 | 8 November 2021 | Effect of COVID-19 on Indian dentists | Imapct of COVID-19 on Indian dentists: a nationwide croos-sectional study | | Nil | 01-10-2021 | 20211001 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61246 | Not Recruiting | No | | | | 08-10-2021 | 300 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Baishakhi Modak | | Room No 5 Department of Prosthodontics and Crown and Bridge Manipal College of Dental Sciences Manipal | baishakhimodak19@gmail.com | 7003782260 | Manipal College of Dental Sciences, Manipal | Inclusion criteria: Registered dental practitioners in various parts in India | Exclusion criteria: subjects who are not willing to participate in the study | | | Fear and anxiety assessment knowledge and practice modificationTimepoint: 3 months | | | | Yes | False | | |
| +++ | CTRI/2021/10/037034 | 8 November 2021 | Mutation study in Covid-19 | A retrospective, non-randomized observational study to detect SARS CoV-19 Delta variants by RT-PCR method in the positive samples archived in the Lab | | Cancyte Technologies Private Limited | 01-10-2021 | 20211001 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61312 | Not Recruiting | No | | | | 14-10-2021 | 100 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Sudarson Sundarrajan | | Cancyte Technologies Private Limited
Molecular Diagnostic Division- Room # 1
Sri Shankara Research Centre
No.9, 1st cross Rangadore Memorial Hospital
Shankarapuram, Bangalore Cancyte Technologies Private Limited
Molecular Diagnostic Division- Room # 1
S | sudarson@cancyte.com | 9738539775 | CANCYTE TECHNOLOGIES PRIVATE LIMITED | Inclusion criteria: All the Covid-19 positive samples collected at Cancyte for the period of Jan 2021-July 2021 | Exclusion criteria: NA | Health Condition 1: U07-U07- Provisional assignment of new diseases of uncertain etiology or emergency use
| Control Intervention1: NIL: NIL<br>Control Intervention2: NA: NA<br> | Detecting presence of Covid-19 delta variants by RT-PCR in the samples collected by Nasopharyngeal and Oropharyngeal swabs preserved at our library.Timepoint: 01 week | | | | Yes | False | | |
| +++ | CTRI/2021/10/037035 | 8 November 2021 | To assess the efficacy and safety of a Nasal Spray in the prevention of
SARS CoV-2 infection to Primary informal caregivers of COVID-19 positive subjects. | A Multicentric, Triple blind, Randomized, Placebo-controlled study
to assess the efficacy and safety of a Nasal Spray in the prevention of
SARS CoV-2 infection to Primary informal caregivers of COVID-19 positive subjects. | | ITC Limited | 01-10-2021 | 20211001 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60817 | Recruiting | No | | | | 09-10-2021 | 480 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator and Outcome Assessor Blinded | N/A | India | Meena Dalal | | Room No 1,3rd Floor, 467,Ist Main Rd, Royal County,8th Phase,Gottigere, Bengaluru | archana.kamath@trialguna.com | 9964666634 | Trial Guna Pvt Ltd | Inclusion criteria: 1.Individuals >18 years, living with individuals with Lab confirmed COVID-19 infection. <br/ ><br>2.Individuals with no clinical symptoms and negative RT-qPCR for COVID19 (SARS CoV-2), insignificant findings during screening, medical history, medical examination, laboratory evaluations. <br/ ><br>3.Individuals agreeing to refrain from taking over the counter products intended to prevent, intervene in, or treat colds/flu, starting at study entry and continuing through the study course. <br/ ><br>4.Individuals willing to use an adequate form of contraception (or <br/ ><br>abstinence) from the time of the first dose with the IP until after the end <br/ ><br>of study course. | Exclusion criteria: 1.Pregnant / lactating women. <br/ ><br>2.Individuals undergoing active cancer / biological/ hormonal treatment. <br/ ><br>3.Individuals previously vaccinated (1/2 doses) against COVID-19 (SARS CoV-2)/ recently vaccinated. <br/ ><br>4.Individuals previously confirmed positive for COVID-19 (SARS CoV-2). <br/ ><br>5.Individuals having previously participated in any clinical trial for COVID19 (SARS-CoV-2) in last three months. <br/ ><br>6.Individuals with history of sinusitis, issues with nasal septum or nasal epithelium conditions. <br/ ><br>7.Individuals with any organ transplantation/ History of thrombocytopenia or any coagulation disorder/ History of allergies / <br/ ><br>sensitivities to any active ingredient of study IP. <br/ ><br>8.Individuals suffering from asthma / taking regular medications administered by inhalation, or via the nasal and oropharyngeal route. <br/ ><br>â?¢ Individuals with Immuno compromised state/ those under immune stimulant therapy. <br/ ><br>9.Patients who have any untreated/uncontrolled reversible medical condition which may cause any harm as per the Investigatorâ??s clinical <br/ ><br>judgement. | | | 1.Percentage of subjects who test positive on RT-qPCR/ RAT/IgG/IgM <br/ ><br>for COVID-19 over the 30 days of the study. <br/ ><br>Timepoint: Over the 30 days of the study <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/10/037036 | 8 November 2021 | Genetic response to Covid-19 infection | A prospective, non-randomised observational study to identify immunological and inflammatory response of the host immune genes to Covid-19 infection. | | Cancyte Technologies Private Limited | 01-10-2021 | 20211001 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61250 | Not Recruiting | No | | | | 18-10-2021 | 8 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Sudarson Sundarrajan | | Cancyte Technologies Private Limited
Molecular Diagnostic Division- Room # 1
Sri Shankara Research Centre
No.9, 1st cross Rangadore Memorial Hospital
Shankarapuram, Bangalore-
Cancyte Technologies Private Limited
Molecular Diagnostic Division- Room # 1 | sudarson@cancyte.com | 9738539775 | CANCYTE TECHNOLOGIES PRIVATE LIMITED | Inclusion criteria: All patients who can read and understand English and given their informed consent <br/ ><br>gave Informed Consent for the study <br/ ><br>Covid-19 RT-PCR positive patients <br/ ><br>Non-Vaccinated , Non-infected , asymptomatic and symptomatic volunteers - (Control Group) <br/ ><br> | Exclusion criteria: Patient who have not given consent for this study <br/ ><br>Pregnancy <br/ ><br>People with the history of Cancer <br/ ><br> | Health Condition 1: U07-U07- Provisional assignment of new diseases of uncertain etiology or emergency use
| | To identify immunological and inflammatory response of the host immune genes to Covid-19 infection.Timepoint: 2 Time points; Day 0 and Day 14 | | | | Yes | False | | |
| +++ | CTRI/2021/10/037066 | 8 November 2021 | Biological Eâ??s CORBEVAX vaccine clinical study for protection against Covid-19 disease in children. | A Prospective, Randomised, Double-blind, Placebo controlled, Phase-II by III Study to Evaluate Safety, Reactogenicity, Tolerability and Immunogenicity of CORBEVAX Vaccine in Children and Adolescents. - None | | Biological ELimited | 04-10-2021 | 20211004 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60393 | Recruiting | No | | | | 11-10-2021 | 624 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 2/ Phase 3 | India | Subba Reddy GV | | Clinical Development Dept, 2nd floor, Road No.35, Jubilee Hills | kishore.turaga@biologicale.com | 04071216247 | Biological E.Limited | Inclusion criteria: 1. Ability to provide written informed consent (by the parents or legally acceptable/authorized representative (LAR) and assent by the children aged between â?¥7 to <18 years. <br/ ><br>2. Subject, in the opinion of the investigator, has ability to communicate and willingness to comply with the requirements of the protocol. <br/ ><br>3. Participants of either gender of age between <18years to â?¥5 (Participant should be <18 years at the time of Screening of the study). <br/ ><br>4. Participants virologically seronegative to SARS-CoV-2 infection by RT-PCR and anti-SARS-CoV-2 antibody prior to enrolment. <br/ ><br>5. Participants considered of stable health as judged by the investigator, determined by medical history and physical examination with normal vital signs as defined in the protocol. [Normal vital sign defined as body temperature <100.4ºF prior to enrolment]. <br/ ><br>6. Agrees not to participate in another clinical trial at any time during the total study period. <br/ ><br>7. Agrees to remain in the town where the study centre is located, for the entire duration of the study. <br/ ><br>8. Willing to allow storage and future use of collected biological samples for future research in an anonymised form. <br/ ><br> | Exclusion criteria: 1. History of vaccination with any investigational vaccine against COVID-19 disease; <br/ ><br>2. Seropositive to IgG antibodies against SARS CoV-2 <br/ ><br>3. Living in the same household of any COVID-19 positive person; <br/ ><br>4. Use of any investigational or non-registered product other than the study vaccine during the trial period or 3 months prior to enrolment; <br/ ><br>5. History of receipt of any licensed vaccine within 1 month prior to screening, likely to impact on interpretation of the trial data (e.g., influenza vaccines); <br/ ><br>6. Current or planned participation in prophylactic drug trials for the duration of the study. <br/ ><br>7. Known history of HIV 1 & 2, HBV and HCV infection in participants prior to enrolment.; <br/ ><br>8. Body temperature of â?¥100.4°F ( >38.0°C) or symptoms of an acute illness at the time of screening or prior to vaccination; <br/ ><br>9. History of severe psychiatric conditions likely to affect participation in the study; <br/ ><br>10. History of any bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder); <br/ ><br>11. History of allergic disease or reactions likely to be exacerbated by any component of the Biological Eâ??s CORBEVAX vaccine formulations; <br/ ><br>12. Chronic respiratory disease, including asthma; <br/ ><br>13. Chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness; <br/ ><br>14. Any other serious chronic illness requiring hospital specialist supervision; <br/ ><br>15. Chronic administration (defined as more than 14 days in total) of immunosuppressant (e.g. corticosteroids, cytotoxic drugs or antimetabolites, etc.) or other immune-modifying drugs (e.g. interferons) during the period starting six months prior to the first vaccine dose including use of any blood products. For corticosteroids, this will mean prednisolone â?¥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed; <br/ ><br>16. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required); <br/ ><br>17. Any medical condition that in the judgment of the investigator would make study participation unsafe. <br/ ><br>18. Individuals who are part of the study team or close family members of individuals conducting the study. <br/ ><br>19. Anaphylactic reaction following administration of the investigational vaccine. <br/ ><br> | | Intervention1: Biological Eâ??s CORBEVAX Vaccine: Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses at Day 0, Day 28 and booster dose on Day 208.<br>Control Intervention1: PLACEBO: Dose: 0.5ml, Route of administration: Intramuscular injection, Frequency: Two doses at Day 0 and Day 28<br> | Phase II: <br/ ><br>1. Occurrence of any adverse reactions. <br/ ><br>2.The occurrence of solicited symptoms and their severity. <br/ ><br>3. The occurrence of any unsolicited adverse events and their severity. <br/ ><br>4. The occurrence and severity of any SAEs or medically attended AEs or AEs of special interest (AESIs). <br/ ><br> <br/ ><br>Phase III: <br/ ><br>1. Immune response in terms of geometric mean neutralizing titres and their geometric mean fold riseTimepoint: Phase II: <br/ ><br>1. Within 60 minutes of immediate post vaccination period after each dose. <br/ ><br>2. 7 consecutive days after each dose. <br/ ><br>3.Till 28 days after each post vaccination period. <br/ ><br>4. 28 days after each dose. <br/ ><br> <br/ ><br>Phase III: <br/ ><br>1. from baseline, at day 42. | | | | Yes | False | | |
| +++ | CTRI/2021/10/037090 | 8 November 2021 | To study lung fuction and residual lung damage in COVID 19 patients who recover from the infections. | Lung function impairment and injury in post COVID 19 infection - LIMPCov | | Christian Medical College Vellore | 05-10-2021 | 20211005 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=54854 | Not Recruiting | No | | | | 18-10-2021 | 400 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Devasahayam J Christopher | | Department of Pulmonary Medicine,
ISSCC building,
Ida Scudder Road, Christian Medical College,
Vellore
India | djchris@cmcvellore.ac.in | 09443306573 | Christian Medical College | Inclusion criteria: 1. Adult inpatients (more than 18 years and older) with positive SARS-CoV-2 RNA detection (throat swab) results and diagnosed with COVID-19 <br/ ><br>2. Willing to sign informed consent <br/ ><br> | Exclusion criteria: 1. Patients not willing to consent or unable to come for follow-up. | Health Condition 1: A00-B99- Certain infectious and parasitic diseases
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
| | 1.Lung function paramenters: FEV1, FVC, TLC, RV, DLco, DLco/VA <br/ ><br>2.6 Min walk test parameters: 6 min walk distance, Distance Saturation Product, Lowest SPO2, Dyspnea Borg scale <br/ ><br>3.CXR/HRCT: Fibrosis, Consolidation, bronchiectasis etc. <br/ ><br>4.SGRQ: Respirtory symptoms, problems, treatment & activities <br/ ><br> <br/ ><br>Timepoint: 4 to 6 weeks, 3 months, 6 months | | | | Yes | False | | |
| +++ | CTRI/2021/10/037099 | 8 November 2021 | Assessment of the protection offered by single dose of COVID-19 vaccines in individuals previously affected with COVID-19 | Evaluation of Immunogenicity, Efficacy and Safety of single dose of COVID-19 vaccines (Covishield, Covaxin and Sputnik V) in previously SARS-CoV2 infected individuals - A Randomized controlled clinical trial | | Indian Council of Medical research ICMR | 05-10-2021 | 20211005 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61426 | Not Recruiting | No | | | | 15-10-2021 | 450 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Open Label | Phase 4 | India | Dr Abinaya Elango | | Department of Pharmacology
Chettinad Hospital and Research Institute
Chettinad Academy of Research and Education
Rajiv Gandhi Salai
Kelambakkam | dr.abi.smc@gmail.com | 9003011630 | Chettinad Hospital and Research Institute, Chettinad Academy of Research and Education | Inclusion criteria: 1.Males and females â?¥18 years and willing to give informed consent <br/ ><br>2.Group I and II: Subjects with positive history of RT-PCR proven COVID-19, 3 months or more, prior to their enrolment <br/ ><br>3.Group III: Subjects with no history of COVID-19 infection in the past <br/ ><br>4.Females should be non-pregnant and willing to adopt contraception for minimum three months (group 1 - 3 months after the 1st dose; group 2 & 3 - during the period between 1st & 2nd doses and 3 months after 2nd dose) <br/ ><br>4.Subjects with co morbidities including Diabetes and Hypertension with stable medical condition <br/ ><br> | Exclusion criteria: 1.Subjects with significant co-morbid conditions with unacceptable clinical and / or laboratory profile in view of the investigator <br/ ><br>2.Those who are on long term steroid therapy (â?¥3 months) and immunosuppressive treatment including anticancer treatment within past 6 months <br/ ><br>3.Those who are in immunosuppressed or immunodeficient state <br/ ><br>4.Subjects with active malignancy of any organ or system <br/ ><br>5.Those who have received blood / blood products / immunoglobulins in the past 3 months <br/ ><br>6.Subjects on regular anticoagulant therapy <br/ ><br>7.History of bleeding disorders <br/ ><br>8.H/O hypersensitivity to any of the vaccines and / or the constituents in the vaccine <br/ ><br> | | Intervention1: Covishield, Covaxin and Sputnik V 0.5 ml IM in deltoid region (single dose for 150 subjects and 2 doses for 150 subjects) in previously COVID-19 infected: Covishield, Covaxin and Sputnik V in individuals who previously had SARS-CoV-2 infection-0.5 ml IM in deltoid region (single dose for 150 subjects and 2 doses for 150 subjects)<br>Control Intervention1: Covishield, Covaxin and Sputnik V in COVID-19 Naive individuals- 0.ml IM in deltoid region-two doses: Covishield, Covaxin and Sputnik V two doses of 0.5 ml each in deltoid region, in individuals who have no prior history of COVID-19 infection<br> | 1.Humoral immune response <br/ ><br>2.Cell-mediated immune response <br/ ><br>Timepoint: Baseline,3 months, 6 months, 9 months and 12 months | | | | Yes | False | | |
| +++ | CTRI/2021/10/037112 | 8 November 2021 | Studying the effectiveness of different Steroids in treatment of COVID-19 | EVALUATING EFFECTIVENESS OF DEXAMETHASONE VS METHYLPREDNISOLONE IN MANAGEMENT OF COVID-19 INFECTION.
| | Dr Sujith Vasireddy | 05-10-2021 | 20211005 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60249 | Not Recruiting | No | | | | 10-10-2021 | 399 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Sujith Vasireddy | | Kasturba Medical College, Madhav Nagar, Manipal | shekar.uk@manipal.edu | 9148552033 | Kasturba Medical College, Manipal | Inclusion criteria: 1)PCR confirmed COVID-19 infection <br/ ><br>2)PaO2/FiO2 < 200 mmHg <br/ ><br>3)Positive pressure ventilation (non-invasive or invasive) or high flow nasal cannula (HFNC) higher than 45 L/min for less than 48 hours <br/ ><br>4)Requiring ICU admission <br/ ><br> | Exclusion criteria: 1)pregnancy; <br/ ><br>2)Severe underlying disease, i.e. end stage of malignancy disease or end stage of pulmonary disease; <br/ ><br>3)Underlying disease requiring corticosteroids; <br/ ><br>Contraindication for corticosteroids <br/ ><br>4)Diseases causing an immunocompromised state, i.e AIDS. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: DEXAMETHASONE: 6MG OD, 6MGBD, 12MG OD<br>Intervention2: NOT APPLICABLE: NOT APPLICABLE<br>Control Intervention1: NOT APPLICABLE: NOT APPLICABLE<br> | ALL CAUSE MORTALITYTimepoint: Till discharge from the hospital | | | | Yes | False | | |
| +++ | CTRI/2021/10/037117 | 8 November 2021 | Comparing postoperative outcomes in neurosurgical patients with previous COVID19 Infection versus no previous Covid infection | Perioperative Outcomes of neuro-Surgical Treatment in Patients with Previous COVID19 Infection (POST COVID19 Study) | | NIMHANS | 06-10-2021 | 20211006 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60206 | Recruiting | No | | | | 16-10-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Sonia Bansal | | Dept. of Neuroanaesthesia and Neurocritical care,
3rd floor,
Faculty block, Neurocentre,
NIMHANS | itz.sonia77@gmail.com | 08026995415 | National Institute of Mental Health and Neurosciences (NIMHANS) | Inclusion criteria: All eligible consecutive consenting adult patients aged 18-80 years undergoing neurosurgeries (both craniotomies and spine surgeries) <br/ ><br>Cases- patients with previous covid 19 infection <br/ ><br>Matched controls- NO previous covid infection (matched for age, gender and diagnosis | Exclusion criteria: Patients aged < 18 years | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: U071- COVID 19 virus identified
| | Incidence of perioperative complications in patients with past COVID19 and with no past COVID19 infection. Secifically, Pulmonary, cardiac, and neurological complications and othersTimepoint: Perioperatve during hospital stay and up to within 4 weeks | | | | Yes | False | | |
| +++ | CTRI/2021/10/037118 | 8 November 2021 | Aerosol free bracket bonding | Efficacy of modified orthodontic bonding technique (MOBT) in COVID-19 dental practice: A randomised clinical trial - MOBT vs COBT | | NIL | 06-10-2021 | 20211006 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57322 | Not Recruiting | No | | | | 11-10-2021 | 200 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India | Dr Anshul Chaudhry | | Department of Orthodontics and dentofacial Orthopaedics, Room number 9 Department of Orthodontics and dentofacial Orthopaedics, Room number 9 | dr.anshulchaudhry@gmail.com | 09872688198 | Christian Dental College | Inclusion criteria: All persons coming for routine orthodontic treatment | Exclusion criteria: Patients with periodontal problems and with poor oral hygiene | Health Condition 1: K088- Other specified disorders of teethand supporting structures
| Intervention1: Orthodontic bonding: Duration for the whole study will be 1 year <br>Frequency: For individual patient, it will be for 7 months; where the patient will be evaluated every month<br>Control Intervention1: Orthodontic bonding: Duration for the study will be 1 year <br>Frequency: For individual patient, it will be for 7 months ; where the patient will be evaluated every month.<br> | MOBT group (Group 1) will be compared to COBT group(Group 2) at all time points.Timepoint: T1 (One month), T2(Two month) ,T3 (Three Month),T4 (Four month),T5 (Five month),T6 (Six month) | | | | Yes | False | | |
| +++ | CTRI/2021/10/037137 | 8 November 2021 | Trial to evaluate 3mg dose of Covid Vaccine of Cadila healthcare Limited
| A prospective, open-label, single arm, multicenter, phase III clinical
study to evaluate the immunogenicity and safety of 3mg (2 dose) regimen of Novel
Corona Virus -2019-nCov vaccine candidate of M/s Cadila Healthcare Limited by
intradermal route in healthy subjects | | Cadila Healthcare Limited | 06-10-2021 | 20211006 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61488 | Not Recruiting | No | | | | 15-10-2021 | 3000 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 3 | India | Dr Jayesh Sanmukhani | | Zydus Corporate Park, Scheme No. 63, Survey No. 536, Khoraj
(Gandhinagar), Nr. Vaishnodevi Circle, S.G. Highway, Ahmedabad | jayeshsanmukhani@zyduscadila.com | 7600012192 | Cadila Healthcare Ltd. | Inclusion criteria: 1. Healthy subject of either gender â?¥12 years of age <br/ ><br>2. Informed consent from the subjects / LAR and assent from subjects â?¥12 to <18 years of age <br/ ><br>3. Adult subjects / LAR literate enough to fill the diary card <br/ ><br>4. Females of childbearing potential, must agree to use one of the approved contraception methods (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization), from screening until completion of the followup visit and males who agree to use contraception | Exclusion criteria: 1. Febrile illness (temperature â?¥ 38°C or 100.4°F) or any acute illness or infection within 4 weeks of enrolment <br/ ><br>2. History or laboratory evidence of confirmed SARS-CoV-2 positive in last 3 months <br/ ><br>3. History of contact with a confirmed active SARS-CoV-2 positive patient within 14 days <br/ ><br>4. Subjects positive for antibodies against SARS-CoV-2 on antibody detection test (for immunogenicity cohort only) / RTPCR positive at the time of screening <br/ ><br>5. History of SARS/ MERS infection <br/ ><br>6. Previous participation in any clinical trial of a SARS-CoV-2 candidate vaccine <br/ ><br>7. Past history of hypersensitivity reaction or any serious adverse event after any vaccination <br/ ><br>8. Subjects with known history of thrombocytopenia or any coagulation disorder, or subjects on anticoagulation therapy <br/ ><br>9. Subjects with confirmed or suspected immunosuppressive or immunodeficiency disorder; or subjects on any immunosuppressive or immunostimulant therapy <br/ ><br>10. Clinically significant systemic disorder such as cardiovascular, respiratory, neurologic, gastrointestinal, hepatic, renal, endocrine, haematological, psychiatric or immunological disorder <br/ ><br>11. Subjects administered blood, blood containing products or immunoglobulins within the last 3 months or planned administration during the study <br/ ><br>12. Any other vaccine administration within the last 30 days or planned to be administered during the study period <br/ ><br>13. Pregnant and lactating women & female subjects not using acceptable contraceptive measures (double barrier methods, oral or injectable hormonal contraceptives or surgical sterilization) <br/ ><br>14. Participation in another clinical trial in the past 3 months <br/ ><br>15. History of drug / alcohol abuse | | Intervention1: Novel Corona Virus-2019-nCov vaccine of M/s.<br>Cadila Healthcare Limited (ZyCoV-D): 3 mg dose (0.1ml dose at three<br>sites) to be given twice at day 0 and 28<br>Control Intervention1: Not Applicable: NA<br> | Non-inferiority based on seroconversion rate based on IgG antibodies against S1 <br/ ><br>antigen (by ELISA) and NAB at Day 56 of 3mg â?? 2 dose regimen against the Day 84 <br/ ><br>data from the ongoing Phase III clinical trial with 2mg â?? 3 dose regimen <br/ ><br> <br/ ><br>Adverse events (solicited, unsolicited and SAEs) reported during the studyTimepoint: Day 56 | | | | Yes | False | | |
| +++ | CTRI/2021/10/037140 | 8 November 2021 | VALIDATION OF EARLY WARNING SCORING SYSTEM TO IDENTIFY HIGHLY SUSPECT COVIDâ??19 OBSTETRIC PATIENTS | DEVELOPMENT AND VALIDATION OF AN APPROPRIATE MODEL OF PREOPERATIVE EARLY WARNING SCORING SYSTEM TO IDENTIFY HIGHLY SUSPECT COVIDâ??19 OBSTETRIC PATIENTS | | ESIC and PGIMSR | 06-10-2021 | 20211006 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61506 | Not Recruiting | No | | | | 15-10-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Nishanth N | | Department of anaesthesiology ESIC and PGIMSR
41st Cross Rd, Rajajinagar, Bengaluru, Karnataka 560010 | nishanth_0891@yahoo.com | 09886010892 | ESIC and PGIMSR | Inclusion criteria: Age 18-40 years <br/ ><br>ASA physical status I, II, III, IV <br/ ><br>All Pregnant patients admitted between April 2020 to January 2021 <br/ ><br> | Exclusion criteria: RT PCR report not available | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Nil: Nil<br>Control Intervention1: Nil: Nil<br> | 1.Evaluate various models of the score relevant to the obstetric population and suggest an appropriate model of the scoring system based on availability of parameters related to subsection of the score. <br/ ><br>2. To obtain cut-off point indicating high chance if RT-PCR positivity for the most appropriate model <br/ ><br>3.Validate the newly developed model of Early warning scoring system <br/ ><br>Timepoint: At the time of admission and primary examination | | | | Yes | False | | |
| +++ | CTRI/2021/10/037148 | 8 November 2021 | Effect of COVID-19 on anxiety of patient undergoing routine surgery | Impact of Coivd-19 on anxiety levels among patients planned for elective surgery. - anxiety | | Sri Aurobindo Medical College PG Institute | 07-10-2021 | 20211007 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59184 | Recruiting | No | | | | 16-10-2021 | 500 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant and Investigator Blinded | N/A | India | Swapnil Kumar Barasker | | Department of Anaesthesiology and Critical Care, Sri Aurobindo
Medical College and PG Institute, Indore Ujjain State Highway, Near MR 10 Crossing | swapnilkbarasker@gmail.com | 08109101245 | Sri Aurobindo Medical College & PG Institute, Indore | Inclusion criteria: Patients undergoing elective surgeries under anesthesia. <br/ ><br>Patients with ASA status I, II <br/ ><br>Patients giving consent for getting included in the study. <br/ ><br>Patients admitted before the day of the surgery <br/ ><br> | Exclusion criteria: 1.Patients who are unable to understand the questionnaire or unable to communicate <br/ ><br>2.Patients previously operated <br/ ><br>3.Oncology surgery <br/ ><br>4.Patients who are known case of Psychiatric illness and on treatment with any psychotropic drug since last month <br/ ><br>5.Patients undergoing emergency surgeries | Health Condition 1: O- Medical and Surgical
| | Impact of COVID-19 on anxiety of patient posted for elective surgery and correlation of demographic factor (age, gender, education, number of days of admission and vaccination status) and clinical factor (diagnosis and surgery) associated with anxiety score.Timepoint: Patient has to answer the questionnaire a night prior to the planned surgery. | | | | Yes | False | | |
| +++ | CTRI/2021/10/037177 | 8 November 2021 | Psychosocial aspects of care for cancer patients afflicted post COVID - 19 | A Study to assess the psychosocial aspects for cancer patients afflicted post COVID-19 at Tata Memorial Hospital - Evaluation of the Psychosocial care aspects for cancer patients afflicted post COVID - 19 at Tata Memorial hospital . | | No SPONSOR | 08-10-2021 | 20211008 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=50978 | Not Recruiting | No | | | | 15-10-2021 | 50 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | N/A | India | Dr Manisha Pawar | | HOMI BHABHA BLOCK , NURSING EDUCATION DEPARTMENT, 13TH FLOOR, DR. E BORGES MARG, PAREL, MUMBAI-12 HOMI BHABHA BLOCK , NURSING EDUCATION DEPARTMENT, 13TH FLOOR, DR. E BORGES MARG, PAREL, MUMBAI-12 | prathepa_jagadish@rediffmail.com | 24177000 | TMH | Inclusion criteria: Cancer patients afflicted with COVID since 15th March to 15th November 2020 and registered with Tata Memorial Hospital. | Exclusion criteria: | Health Condition 1: C801- Malignant (primary) neoplasm, unspecified
Health Condition 2: Z859- Personal history of malignant neoplasm, unspecified
| | To understand the impact of cancer patients afflicted with COVID in the areas of physical and emotional domains.Timepoint: 8 weeks | | | | Yes | False | | |
| +++ | CTRI/2021/10/037178 | 8 November 2021 | Complications for surgery after COVID 19 infection | Outcomes in patients undergoing surgery with preoperative SARS CoV2 infection - a cohort study - Nil | | Dr Sara Vergis | 08-10-2021 | 20211008 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55400 | Not Recruiting | No | | | | 15-10-2021 | 160 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Sara Vergis | | Department of Anaesthesia
MOSC Medical College
Kolenchery | skorula@gmail.com | 9446596066 | MOSC Medical College | Inclusion criteria: Patients who had SARSCoV2 infection within 90 days prior to surgery. | Exclusion criteria: Patients without SARSCoV2 infection <br/ ><br>Patients with SARSCoV2 infection more than 90 days before surgery | Health Condition 1: O- Medical and Surgical
| | Perioperative complicationsTimepoint: Post operative day 1 and day7. | | | | Yes | False | | |
| +++ | CTRI/2021/10/037179 | 8 November 2021 | A study to see if doing Yoga in addition to routine treatment of new anxiety disorders due to the COVID-19 pandemic is effective | Efficacy of Yoga Nidra as Adjuvant Treatment in Patients with New-Onset Anxiety Disorders during COVID-19 Pandemicâ?? A Pilot Study | | Dr Jitendra Rohilla | 08-10-2021 | 20211008 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61654 | Not Recruiting | No | | | | 20-10-2021 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable | N/A | India | Dr Jitendra Rohilla | | Room No 016413, Department of Psychiatry ACADEMIC BLOCK, AIIMS RISHIKESH, VIRBHADRA ROAD, RISHIKESH | jiten.sms@gmail.com | 9414531839 | Department of Psychiatry, All India Institute of Medical Sciences, RISHIKESH | Inclusion criteria: [1] Anxiety disorder F40-F48 as per ICD-10 <br/ ><br>[2] Both Gender <br/ ><br>[3] Above 18 years | Exclusion criteria: [1] Psychiatry illness other than anxiety disorders <br/ ><br>[2] Past history of anxiety disorder <br/ ><br>[3] Anxiety disorder due to known physiological condition (F06.4 as per ICD-10) | Health Condition 1: F40-F48- Anxiety, dissociative, stress-related, somatoform and other nonpsychotic mental disorders
| Intervention1: Yoga Nidra: FREQUENCY: twice daily, for at least 5 days a week<br>DURATION : 12 WEEKS<br><br><br>During the practice of Yoga Nidra, one appears to be asleep, but the consciousness is functioning at a deeper level of awareness. The state of Yoga Nidra is the state between waking and sleep, but it is subject to neither It consists of seven steps, first is preparation for the practice, second is Resolvation, third is the rotation of consciousness, fourth is awareness of breath, fifth is feeling and sensations, sixth is visualization and seventh is ending of practice. The practice of Yoga Nidra is concluded by gradually bringing the mind from the condition of psychic sleep to the<br>waking state.<br>Control Intervention1: Standard Psychiatry Treatment: FREQUENCY : DAILY ONCE<br>DURATION : 12 WEEKS<br><br>Psychotropic medications prescribed as part of routine treatment in department of psychiatry<br> | anxiety severity score as measured by Hamilton Anxiety Rating Scale HAM-ATimepoint: first week, 4 weeks, 8 weeks, 12 weeks | | | | Yes | False | | |
| +++ | CTRI/2021/10/037195 | 8 November 2021 | Abdominal symptoms in COVID 19 and its association with inflammatory markers | Frequency of acute abdominal symptoms in COVID-19 and its association with inflammatory markers | | M S RAMAIAH MEDICAL COLLEGE | 08-10-2021 | 20211008 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61406 | Not Recruiting | No | | | | 30-11-2021 | 489 | Observational | Other<br> Method of generating randomization sequence: Method of allocation concealment: Blinding and masking: | N/A | India | Dr Madan K | | Ramaiah Medical College Hospital, MSR Nagar, MSRIT Post, Bangaluru 560054 Ramaiah Medical College Hospital, MSR Nagar, MSRIT Post, Bengaluru 560054 | maddy.im05@gmail.com | 9632312132 | Ramaiah Medical College and Associated Hospitals | Inclusion criteria: All patients admitted with abdominal symptoms in COVID care center | Exclusion criteria: | Health Condition 1: J069- Acute upper respiratory infection,unspecified
Health Condition 2: K929- Disease of digestive system, unspecified
Health Condition 3: K928- Other specified diseases of the digestive system
| | Mobidity And mortality in COVID 19 cases during the course in the hospitalTimepoint: from admission to discharge | | | | Yes | False | | |
| +++ | CTRI/2021/10/037257 | 8 November 2021 | Topical Antifungal Therapy in COVID Associated Mucormycosis: A new hope? | A Multi-arm, parallel Randomised Control Trial to compare the efficacy of 0.1% w/w Liposomal Amphotericin-B gel with 10% w/w povidine-iodine and saline nasal douching in preventing revision surgery in patients with COVID associated mucormycosis and to develop AIIMS Bhubaneswar Mucormycosis Endoscopic Scoring System (AMESS) for quantification of response to treatment | | Dr Zaid Shaikh | 12-10-2021 | 20211012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60286 | Recruiting | No | | | | 13-10-2021 | 45 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Stratified block randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant Blinded | N/A | India | Dr Chappity Preetam | | Department of ENT and HNS, AIIMS Bhubaneswar | drcpreetam@aiimsbhubaneswar.edu.in | | AIIMS Bhubaneswar | Inclusion criteria: Patients were microbiologically and histologically proven cases of mucormycosis and underwent open or endoscopic surgical debridement for Mucormycosis. Patients must have received a minimum of three weeks of systemic Amphotericin B administration postoperatively without any discontinuity | Exclusion criteria: Patients having mandibular or disseminated forms of mucormycosis, where study participants refused giving prior consent of participation. Patients who were deceased before three weeks or had interruption in treatment with systemic Amphotericin B | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: 0.1% w/w Lipid based Liposomal Amphotericin-B gel 1mg/gm application in postoperative cavity of patients undergoing open or endoscopic debridement for COVID Associated Mucormycosis: Serial Diagnostic Nasal Endoscopy on postoperative day 7, 14 and 21 and graded according to AIIMS Bhubaneswar Mucormycosis Endoscopic Scoring System (AMESS). Postoperative cavity will be smeared with 5 grams Lipid based Liposomal Amphotericin-B gel on respective days . Patients will be given Saline nasal Douching with Sodium Chloride Powder(4g/200ml) after removal of postoperative pack thrice daily<br>Intervention2: 10% w/w Povidone-Iodine ointment application in postoperative cavity of patients undergoing open or endoscopic surgery for COVID associated Mucormycosis: Serial Diagnostic Nasal Endoscopy on postoperative day 7, 14 and 21 and graded according to AIIMS Bhubaneswar Mucormycosis Endoscopic Scoring System (AMESS). Postoperative cavity will be smeared with 5 grams of Povidone-Iodine ointment on the respective days. Patients will be given Saline nasal douching with Sodium Chloride Powder(4g/200ml) after removal of postoperative nasal pack thrice daily<br>Control Intervention1: Nasal douching with sodium chloride powder (4g/200ml).: Serial Diagnostic Nasal Endoscopy on postoperative day 7,14 and 21 done and graded according to AIIMS Bhubaneswar Mucormycosis Endoscopic Scoring System (AMESS). Nasal douching with sodium chloride powder (4g/200ml) given after removal of nasal pack thrice daily<br> | Primary outcome is to assess the number of patients requiring revision surgery for mucormycosis residual/recurrenceTimepoint: Postoperative day 7, 14 and 21 evaluation | | | | Yes | False | | |
| +++ | CTRI/2021/10/037259 | 8 November 2021 | A Comparison of a specific blood marker for coagulation in Covid 19 patients with and without diabetes as a comorbidities so that to assess the impact of diabetes with covid disease severity | A comparison of D Dimer values in Covid 19 patients with and without Type 2 Diabetes Mellitus | | DR TMA PAI HOSPITAL | 12-10-2021 | 20211012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60666 | Not Recruiting | No | | | | 22-10-2021 | 432 | Observational | Other<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:Case Record Numbers Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 2/ Phase 3 | India | DR Numan A M | | DR TMA PAI Hospital
Udupi
576101 Little archana apartment
Brahmagiri Udupi
576101 | shashikiran.u@manipal.edu | 9008418171 | DR TMA PAI Hospital | Inclusion criteria: ALL COVID POSITIVE PATIENTS FROM ABOVE 18 YEARS OF AGE ADMITTED IN DR TMA PAI HOSPITAL FROM 1 MARCH 2020 TO 30 SEPTEMBER 2020 | Exclusion criteria: PATIENTS WITH TYPE 1 DM <br/ ><br>PATIENTS WITH PRE EXISTING HISTORY OF THROMBOEMBOLISM AND DIC <br/ ><br>PATIENTS ON ANTICOAGULANTS <br/ ><br>PREGNANT AND LACTATING WOMEN <br/ ><br>KNOWN CASE OF CKD AND CLD <br/ ><br>PATIENTS WITH MALIGNANCY NOT UNDER REMISSION | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Control Intervention1: Dr Shashikiran U: HOD Medicine department<br>Dr TMA Pai hospital<br>Udupi<br>Control Intervention2: NOT APPLICABLE: NOT APPLICABLE<br> | COMPARISON OF D DIMER VALUES IN COVID PATIENTS WITH AND WITHOUT DIABETESTimepoint: 2 YEARS | | | | Yes | False | | |
| +++ | CTRI/2021/10/037267 | 8 November 2021 | A study to understand the challenges faced to perform activity during the Corona virus pandemic among the elderly | Challenges and strategies for performing physical activity during the COVID-19 pandemic among older adults in institutions | | Joyceliene Fiona Dsouza | 12-10-2021 | 20211012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60801 | Not Recruiting | No | | | | 25-10-2021 | 24 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Sidhiprada Mohapatra | | Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal | girish.n@manipal.edu | | Manipal College of Health Professions | Inclusion criteria: for residents: <br/ ><br>Who have had minimum stay of 2 years, <br/ ><br>Age: 60 years and above, <br/ ><br>Who achieve a score of >3/5 on Mini-Cog, <br/ ><br>Who are functionally independent and have been indulging in physical activity before lockdown. <br/ ><br> <br/ ><br>for caregivers: <br/ ><br>Minimum of 2 years of experience in providing the service <br/ ><br>Able to participate in the interview, <br/ ><br>Should have been present in the institution during lockdown. <br/ ><br> <br/ ><br> | Exclusion criteria: for residents: <br/ ><br>Who are bed ridden/need special care and attention on a daily basis, <br/ ><br>With hearing deficit or speech deficit. <br/ ><br> <br/ ><br>for caregivers: <br/ ><br>Part-time Caregivers, <br/ ><br>Caregivers who provide only financial support to the institute to avoid bias. <br/ ><br> <br/ ><br> | | | Interview guideTimepoint: At baseline | | | | Yes | False | | |
| +++ | CTRI/2021/10/037269 | 8 November 2021 | A study to assess the safety and immunogenicity of Anti-COVID-19 AKS-452 vaccine for SARS-Сov-2
infection in Indian healthy subjects.
| A randomized, double-blinded, placebo-controlled, parallel-group, multi-centre,
adaptive, seamless bridging study followed by a phase II/III study to assess the
safety and immunogenicity of Anti-COVID-19 AKS-452 vaccine for SARS-Сov-2
infection in Indian healthy subjects. | | Akston Biosciences Corporation | 12-10-2021 | 20211012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59540 | Not Recruiting | No | | | | 25-10-2021 | 1600 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India | Dr Ravi Alamchandani | | Veeda Clinical Research Ltd
Shivalik Plaza, Near I.I.M.
Ambawadi, Ahmedabad 380 015 India | Ravi.A1950@veedacr.com | 7930013000 | Veeda Clinical Research Pvt, Ltd. | Inclusion criteria: 1. Written informed consent of a subject to participate in the trial. <br/ ><br>2. Males and females aged â?¥18 years. <br/ ><br>3. Negative human immunodeficiency virus (HIV 1 & 2) and hepatitis B and C test <br/ ><br>results. <br/ ><br>12. Sexually active women, unless surgically sterile (at least 6 months prior to Study <br/ ><br>drug administration) or postmenopausal for at least 12 consecutive months, must <br/ ><br>use an effective method of avoiding pregnancy (including oral, transdermal, or <br/ ><br>implanted contraceptives [any hormonal method in conjunction with a secondary <br/ ><br>method], intrauterine device, female condom with spermicide, diaphragm with <br/ ><br>spermicide, absolute sexual abstinence, use of condom with spermicide by sexual <br/ ><br>partner or sterile [at least 6 months prior to Study drug administration] sexual <br/ ><br>partner) for at least 1 month prior to study drug administration, during study and <br/ ><br>up to 6 month after the last dose of study drug. Cessation of birth control after this <br/ ><br>point should be discussed with a responsible physician. <br/ ><br>10. No evident vaccine-induced reactions or complications after receiving immune <br/ ><br>biological products in the medical history. <br/ ><br>11. No acute infectious and/or respiratory diseases within at least 14 days before the <br/ ><br>enrolment. <br/ ><br>5. Negative COVID-19 Reverse Transcriptase-Polymerase Chain Reaction (RT-PCR) test result at the screening visit (72 hours prior to Visit 2 [Day 1]). <br/ ><br>6. No history of COVID-19 infection. <br/ ><br>7. No history of receiving any COVID-19 vaccine (even a single dose) prior to <br/ ><br>enrollment. <br/ ><br>8. No history of contact with patients with COVID-19 infections within at least 14 <br/ ><br>days before the enrolment (according to history provided by subjects). <br/ ><br>9. Negative serum pregnancy test at the screening visit and negative urine pregnancy <br/ ><br>test at randomization visit for child-bearing age women. <br/ ><br>4. Negative immunoglobulin M (IgM) and immunoglobulin G (IgG) SARS-CoV-2 <br/ ><br>antibodies through enzyme immunoassay test result. <br/ ><br>13. In case of male subjects: either partner or subject must use an effective method of <br/ ><br>avoiding pregnancy for at least 1 month prior to study drug administration, during <br/ ><br>study and up to 3 month after the last dose of study drug. Cessation of birth control <br/ ><br>after this point should be discussed with a responsible physician. <br/ ><br>It is investigatorâ??s responsibility to ensure that above points regarding an effective <br/ ><br>method of avoiding pregnancy are discussed with subject/legally acceptable <br/ ><br>representative in detail and subject agreed for this and it is documented in <br/ ><br>source document. The investigator should ensure that the subject is using an effective <br/ ><br>method of avoiding pregnancy as per protocol. LAR is an individual or juridical or <br/ ><br>other body authorised under applicable law to represent the interests of an individual, <br/ ><br>including providing consent on behalf of a prospective subject to the subject <br/ ><br>participation in the clinical trial. <br/ ><br>Women must not participate in egg donation programs for assisted reproductive <br/ ><br>technologies for 3 months after the administration of the last dose of the vaccine <br/ ><br>studied. Men must not donate sperm for assisted reproductive technologies for 3 <br/ ><br>months after the administration of the last dose of the vaccine studied. | Exclusion criteria: 1. Any vaccination/immunization within 30 days before the enrolment. <br/ ><br>2. Steroids (except hormonal contraceptives) and/or immune globulins or other <br/ ><br>blood products therapy not finished 30 days before the enrolment. <br/ ><br>3. Immuno suppressor therapy finished within 3 months before the enrolment. <br/ ><br>4. Pregnancy or breast-feeding. <br/ ><br>5. Acute coronary syndrome or stroke suffered less than one year before the <br/ ><br>enrolment. <br/ ><br>6. Tuberculosis, chronic systemic infections. <br/ ><br>7. Drug allergy anaphylactic shock, Quincke s edema, polymorphic exudative <br/ ><br>eczema, atopy, serum disease, hypersensitivity or allergic reaction to immune <br/ ><br>biological products, known allergic reactions to study product components, acute <br/ ><br>exacerbation of allergic diseases on the enrolment day. <br/ ><br>8. Subjects who are on drugs that could have potential drug interactions with the <br/ ><br>vaccine:drugs for multiple sclerosis (dimethyl fumarate, fingolimod, ozanimod, etc.), <br/ ><br>ï?· monoclonal antibodies, corticosteroids, corticotropin,antineoplastic drugs, cytostatic agents (platinum-based drugs, bleomycin, <br/ ><br>taxanes, methotrexate, melphalan, capecitabine, carmustine, vincristine, <br/ ><br>vinblastine, cyclophosphamide, cyclosporine, docetaxel, doxorubicin, <br/ ><br>daunorubicin, fluorouracil, etc.) and target drugs (dasatinib, lenalidomide, <br/ ><br>nilotinib, pemetrexed, everolimus, sirolimus, asparaginase, bortezomib, etc.) <br/ ><br>immune globulins, interleukins, X-ray contrast agents. <br/ ><br>9. Medical history of malignancy. <br/ ><br>10. Donated blood or plasma (450+ mL) within 2 months before the enrolment. <br/ ><br>11. Splenectomy in the medical history. <br/ ><br>12. Neutropenia (absolute neutrophil count <1,000 mm3), agranulocytosis, significant <br/ ><br>blood loss, severe anaemia (haemoglobin <80 g/L), immunodeficiency including <br/ ><br>autoimmune disorders in the medical history within 6 months before the <br/ ><br>enrolment. <br/ ><br>13. Active form of a disease caused by the HIV and hepatitis B or C. <br/ ><br>14. Anorexia, protein deficiency of any origin. <br/ ><br>15. Tattoos at the injection site, which does not allow assessing the local response to <br/ ><br>the IMP/placebo administration. <br/ ><br>16. Alcohol or drug addiction in the medical history. <br/ ><br>17. Participation in any other interventional clinical trial within 1 month prior to the <br/ ><br>screening. <br/ ><br>18. Any other medical condition that would limit the participation of the subject as <br/ ><br>per Investigatorâ??s discretion. <br/ ><br>19. Study centre staff or other employees directly involved in the trial and their <br/ ><br>families. <br/ ><br>20. Subjects contraindicated for vaccination. | | Intervention1: Anti-COVID-19 AKS-452 vaccine: Test product (Anti-COVID-19 AKS-452 Vaccine as two doses: 0.5 mL,(comprising Test product (150µL AKS-452)<br>Each subject will be administered two doses of the IMP, subcutaneously, during Visit<br>2 (Day 1) and Visit 3 (Day 28±2).<br>Control Intervention1: Mixture of normal saline (30% by volume) and Montanide ISA 720 adjuvant (70% by volume) (500<br>µL of adjuvanted placebo volume): Medical grade injectable normal saline sourced, sterile filtered, and filled into sterile<br>vials similar to AKS-452-IMP. Manufacturer of injectable normal saline â?? Sodium chloride 0.9% solution<br>for infusion Product<br>Each subject will be administered two doses of the IMP, subcutaneously, during Visit<br>2 (Day 1) and Visit 3 (Day 28±2).<br> | To evaluate the safety, tolerability and humoral immunogenicity profile of AKS- <br/ ><br>452 following two injections in a combinatorial bridging and phase II/III clinical <br/ ><br>study at day 56.Timepoint: To evaluate the safety, tolerability and humoral immunogenicity profile of AKS- <br/ ><br>452 following two injections in a combinatorial bridging and phase II/III clinical <br/ ><br>study at day 56. | | | | Yes | False | | |
| +++ | CTRI/2021/10/037271 | 8 November 2021 | Brain tumor surgeries during COVID 19 pandemic | Neurosurgical oncology practice during COVID 19 pandemic â?? Experience from a tertiary neurosurgical oncology centre - COVID 19, Neurosurgery | | NA | 12-10-2021 | 20211012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61487 | Not Recruiting | No | | | | 20-10-2021 | 550 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Vikas Singh | | Neurosurgery, Department of surgical oncology, Tata memorial hospital room no 1206, Homi bhabha block, Dr Borges road, Parel, mumbai | drvikaskumarsingh@gmail.com | 9594883899 | Tata memorial hospital, parel | Inclusion criteria: All neurosurgical procedures performed during the two time cohorts at TMH and ACTREC <br/ ><br>group A - 16 march 2019 - 31 december 2019 <br/ ><br>group B - 16 march 2020 - 31 december 2020 | Exclusion criteria: Patients with incomplete data | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | peri operative surgical variables - SSI, Morbidity, MortalityTimepoint: 4 Weeks | | | | Yes | False | | |
| +++ | CTRI/2021/10/037272 | 8 November 2021 | ICD requirement in COVID-19 patients | Assessment of potential risk factors, characteristics, and outcome of pneumothorax and pneumomediastinum in patients with COVID 19 disease. | | Ramaiah Medical College And Hospital | 12-10-2021 | 20211012 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61471 | Not Recruiting | No | | | | 30-11-2021 | 25 | Observational | Single Arm Trial<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr PRASANNA KUMAR T | | Ramaiah Medical College
Department of Respiratory Medicine
M S Ramaiah Nagar
MSRIT Post
Bangalore | prasanna9482@gmail.com | 9902708710 | Rguhs | Inclusion criteria: Patients with covid 19 with pneumothorax and pneumomediastinum | Exclusion criteria: Known severe copd | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J931- Other spontaneous pneumothorax
| Control Intervention1: Nil: COVID patients with pneumothorax and pnemomediastinum<br> | Mortality and morbidity in patients requiring ICD InsertionTimepoint: from the time of admission to discharge | | | | Yes | False | | |
| +++ | CTRI/2021/10/037310 | 8 November 2021 | patients undergoing emergency surgery after recovering from covid 19 | Patients presenting for emergency surgery after recovery from covid 19: A prospective observational trial to measure thirty days mortality | | SANJAY KUMAR | 13-10-2021 | 20211013 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59649 | Not Recruiting | No | | | | 01-11-2021 | 100 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | DR SANJAY KUMAR | | DEPARTMENT OF ANESTHESIA AND INTENSIVE CARE , NEHRU HOSPITAL , PGIMER CHANDIGARH | sanjayjaswal247@gmail.com | | PGIMER CHANDIGARH | Inclusion criteria: patients presenting for emergency surgery after recovering from covid | Exclusion criteria: 1) Patients unlikely to survive beyond 48 hours with or without surgery <br/ ><br> (ASA physical status five) <br/ ><br> <br/ ><br>2) Patients with symptoms suggestive of covid 19 <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | MORTALITYTimepoint: 30 days | | | | Yes | False | | |
| +++ | CTRI/2021/10/037337 | 8 November 2021 | A study to find out the effect of Covid Vaccine in patients living with HIV/AIDS in central Kerala and to identify different types of SARS CoV2 viruses affecting these patients | Effectiveness of Covid Vaccine and identification of SARS CoV2 Variants among PLHIV in Central Kerala â?? An Ambi-directional Cohort Study | | ICMR | 14-10-2021 | 20211014 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61846 | Not Recruiting | No | | | | 15-11-2021 | 910 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Joe Thomas | | Dept of Community Medicine
Jubilee Mission Medical College and Research Institute
Thrissur
Kerala 680005 Dept of Community Medicine
Jubilee Mission Medical College and Research Institute
Thrissur
Kerala 680005 | covidjmmcri@gmail.com | 9447960010 | Jubilee Mission Medical College and Research Institute Thrissur | Inclusion criteria: PLHIV above 18 years of age | Exclusion criteria: Any participant not able to communicate coherently or is non-ambulatory (mentally ill, dementic, bedridden, unconscious & comatose) | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B20- Human immunodeficiency virus [HIV]disease
| Control Intervention1: NIL: NIL<br> | Vaccine effectiveness of COVID-19 vaccines among PLHIVTimepoint: 12 months | | | | Yes | False | | |
| +++ | CTRI/2021/10/037338 | 8 November 2021 | Shwadanshtradi rasayan for post covid -19 syndrome
| A Randomized Open Label Single Group Clinical Trial to Evaluate the Efficacy of
Shwadanshtradi Rasayan in Rasakshay of Post Covid-19 patients.
| | Ashtang Ayurved Pharmacy Dhule | 14-10-2021 | 20211014 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61815 | Recruiting | No | | | | 21-10-2021 | 35 | Interventional | Single Arm Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | Phase 2/ Phase 3 | India | Chinmayee Pravin joshi | | Department of Swasthavrutta , Room no 12 , Smt.K.C.Ajmera Ayurved Mahavidyalay Dhule , Maharashtra. 15, Shri Ram nagar wadi bhokar road deopur Dhule, Maharashtra. | ashtang.ayur.pharma@gmail.com | 8669154827 | Smt.K.C.Ajmera ayurved mahavidyalay dhule. Maharashtra | Inclusion criteria: i) Patients of Post Covid-19 came under duration of > 21 days to 1 year after RTPCR report. <br/ ><br>ii) Patients of Post covid â?? 19 showing classic <br/ ><br> feature of Rasakshay[23]. <br/ ><br>iii) Patients between age group of 18-70 years will be included. <br/ ><br>iv) The patients will be included after Shodhana. <br/ ><br> | Exclusion criteria: Patients with serious life threatening diseases will be <br/ ><br> Excluded. <br/ ><br> ii) Patients with age group below 18 and above 70 will be excluded. <br/ ><br> iii) Pregnant women , children will be Excluded. <br/ ><br> <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
| | Rasakshay in post covid -19 syndromeTimepoint: day 0 and day 21 | | | | Yes | False | | |
| +++ | CTRI/2021/10/037353 | 8 November 2021 | The effect of Himalaya oro-T oral rinse and chlorhexidine on oral health among COVID-19 recovered Dental students | Comparative evaluation of anti-plaque and anti-gingivitis efficacy of Himalaya oro-T oral rinse and chlorhexidine among COVID-19 recovered Dental students- A randomized controlled trial | | Dr SWATISHREE SAHOO self | 18-10-2021 | 20211018 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61837 | Not Recruiting | No | | | | 25-10-2021 | 58 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant Blinded | Phase 2 | India | Dr Swatishree sahoo | | Department no. 3
Sudha Rustagi college of dental sciences and research
Faridabad | maryacm@yahoo.co.uk | 9811144408 | SUDHA RUSTAGI COLLEGE OF DENTAL SCIENCES AND RESEARCH | Inclusion criteria: 1) Patients recovered from COVID-19 within 3 months <br/ ><br>2) Having minimum of 20 teeth. <br/ ><br>3) Who will sign the consent form. <br/ ><br>4) Having DMFT > 1. <br/ ><br> | Exclusion criteria: 1. Individuals with orthodontic or prosthetic appliances that could interfere with evaluation; <br/ ><br>2. individuals with an allergy to any ingredients of mouthwash used in the study; <br/ ><br>3. pregnant or lactating females; <br/ ><br>4. motor skills disorder. <br/ ><br> | | Intervention1: Himalaya Oro-T oral rinse: On day 1 whole mouth was made plaque free by professional prophylaxis with rubber cups and prophylaxis paste and proximal surfaces with the help of dental floss. On day 14 and day 21, Plaque scores and gingival scores were assessed. To stain the plaque teeth were rinsed with water, dried and isolated with cotton rolls. Plaque disclosing solution was then applied on the buccal surfaces of the teeth. After 30 seconds the teeth were rinsed, dried and then staining was evaluated on the mesiobuccal, buccal and distobuccal areas of the test teeth, using a classification system Plaque Free Zone (PFZ) criteria proposed by Maliska et al. PFZ SCORING CRITERIA<br>criterion 0- plaque-free dental surface<br> criterion 1- presence of disclosed plaque and presence of a PFZ<br> criterion 2- subgingival extension of the plaque (presence of disclosed plaque and absence of a PFZ)<br>After the plaque index, the Gingival Index (GI) by Loe and Silness was evaluated on day 14 and on day 21 on the distofacial, facial, mesiofacial and lingual surfaces of the test teeth with the help of mouth mirror and probe. After this the participants was instructed to perform their routine oral home care (brushing, flossing or interproximal cleaning) twice daily and, immediately after, to rinse with 1 ml mouthwash diluted in a measuring cup (15 ml) of water for 2 min. All patients were instructed to not rinse/eat anything for 30 min after mouthwash use. Participants were followed up on the 14th and 21st day.<br><br>Control Intervention1: chlorhexidine mouthwash: The same procedure was done for the positive control group using chlorhexidine mouthwash.<br> | 1) Comparison of mean plaque scores in both the mouthwashes <br/ ><br>2) Comparison of mean gingival scores in both the treatment groups <br/ ><br>3) Patient satisfaction scores on mouthwashes. <br/ ><br>Timepoint: 14th day and 21st day | | | | Yes | False | | |
| +++ | CTRI/2021/10/037365 | 8 November 2021 | Can learning Bhagavad Gita or Yoga reduce stress for COVID-19 frontline healthcare workers? | Interventions to reduce stress among healthcare workers during the COVID-19 pandemic: a comparison of the stress reduction potential of Yoga and Bhagavad Gita - YBGBCOVID | | Nishant Das | 18-10-2021 | 20211018 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58533 | Not Recruiting | No | | | | 25-10-2021 | 44 | Interventional | Randomized, Parallel Group, Multiple Arm Trial<br> Method of generating randomization sequence:Coin toss, Lottery, toss of dice, shuffling cards etc Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Outcome Assessor Blinded | N/A | India | Nishant Das | | Department of Humanities and Social Sciences,
Indian Institute of Technology (ISM), Dhanbad | laalithya@gmail.com | 7020886883 | Samanjasa Foundation | Inclusion criteria: Healthcare workers older than 18 years of age, who are directly involved in treating patients during the COVID-19 pandemic | Exclusion criteria: Those who are not older than 18 years of age, those who are not healthcare workers, and healthcare workers who are not directly involved in treating patients during the COVID-19 pandemic | | Intervention1: Bhagavad Gita: The participants are imparted the teachings of the second chapter of the Bhagavad Gita for 1 week, for 60 minutes per day. The teachings of the Bhagavad Gita are to be imparted by a trained teacher<br>Intervention2: Yoga: The participants are taught a pre-determined sequence of yoga poses for 60 minutes by a trained teacher, every day, for 1 week.<br>Intervention3: Yoga and Gita: The participants are taught a pre-determined sequence of yoga poses for 30 minutes by a trained teacher, followed by 30 minutes of 2nd chapter of Bhagavad Gita lessons from a trained teacher, every day, for 1 week.<br>Control Intervention1: Control: The participants receive no intervention<br> | Reduction in the average GAD7 scores of the participants by at least 1 severity level compared to the score before the start of the interventionTimepoint: Before the intervention (day 0), immediately after the intervention (day 7), 40 days after the intervention (day 47) | | | | Yes | False | | |
| +++ | CTRI/2021/10/037368 | 8 November 2021 | Clinical trial on Covid patients | A Prospective, Open Label Multicenter Clinical Study To Evaluate The Safety And Efficacy Of An Ayurvedic Formulation (Coviraksha) As Adjunct Treatment To Standard Of Care For The Management Of Mild To Moderate Covid-19 Patients. | | Nutan Labs OPC Private Limited | 18-10-2021 | 20211018 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61677 | Not Recruiting | No | | | | 18-10-2021 | 60 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Case Record Numbers Blinding and masking:Open Label | Phase 3/ Phase 4 | India | HS Nuthan | | NO 188/32/1 FIRST FLOOR
13TH CROSS OPP TO PINK SQUARES
PHASE 1 BASHYAM CIRCLE BANGALORE 560080
| director@nutanlabs.com | 9071149995 | Nutan Labs (OPC) Pvt Ltd, | Inclusion criteria: 1. Subjects aged 18-65 years of age and of either sex <br/ ><br>2. Subjects who are willing to give consent to the study <br/ ><br>3. COVID-19 positive clinical symptoms and (subsequently) confirmed by the current recommended confirmatory test (Nasal swab RT-PCR). <br/ ><br>4. Mild to moderate clinical disease <br/ ><br>5. Can take oral medicines <br/ ><br>6. Subject willing to abide by and comply with the study protocol <br/ ><br> | Exclusion criteria: 1. Age less than 18 years and more than 65 years <br/ ><br>2. Pregnancy and lactation <br/ ><br>3. Severe or complicated course of COVID-19 disease <br/ ><br>4. Presence of Pneumonia/ acute hypoxic respiratory failure/ need for Intensive care unit (ICU) stay/ Patients who need mechanical ventilation. <br/ ><br>5. Subjects taking steroid treatment and or any kind of immunosuppressive therapy <br/ ><br>6. Any uncontrolled systemic disease/ infection <br/ ><br>7. Those with serious Cardiovascular, Cerebrovascular, Respiratory, Liver or renal disease or any other disorder. <br/ ><br>8. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Standard of care along with COVIRAKSHA Ayurvedic proprietary medicine -Inhaler: Dosage form: Inhaler<br>Duration: 7 to 9 times/day, Roll on the palms and inhale the vapor for 7 to 14 days<br><br><br>Control Intervention1: Standard of care recommended by ICMR guidelines for mild to moderate covid -19 patients: As per Principal investigator recommendations<br> | 1.To Evaluate the Safety and Efficacy of COVIRAKSHA to Resolution of symptoms and Recovery of patients from COVID 19 disease compared to patients taking only standard of care treatment <br/ ><br>2.Improvement in the clinical features in mild to moderate Covid patients. <br/ ><br>3.Mean time (days) for clinical recovery <br/ ><br>Timepoint: Day 0 to Day 14 | | | | Yes | False | | |
| +++ | CTRI/2021/10/037377 | 8 November 2021 | PAN-Fortis Retrospecitve data collection study for Vaccinated PAN-FORTIS Healthcare Workers infected with SARS-CoV-2 /
COVID-19 post vaccination | Fortis Registry Study for Vaccinated Healthcare Workers infected with SARS-CoV-2 /
COVID-19 | | Fortis Healthcare Limited | 20-10-2021 | 20211020 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56923 | Not Recruiting | No | | | | 29-10-2021 | 1000 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Mr Saptarshi Goswami | | Fortis Hospital
Clinical Research Dept
Room no 1020
10th Floor
730 Anandapur
| sulabh.80@gmail.com | 9810401423 | Fortis Hospital | Inclusion criteria: All Vaccinated PAN FORTIS healthcare workers infected with COVID 19 | Exclusion criteria: All non vaccinated PAN FORTIS healthcare workers | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | To evaluate real world clinical efficacy of COVID vaccines in healthcare workers across Fortis network of hospitals. The assumption being that the health care workers being frontline warriors, are working directly/closely with the patients and have an overall higher risk of exposure to SARS-CoV-2 than the normal individualTimepoint: From Date of 1st or 2nd dose of vaccination to the date of 1st COVID-19 infection | | | | Yes | False | | |
| +++ | CTRI/2021/10/037378 | 8 November 2021 | Clinical Trial of Polyherbal Formulation COVI-RB01 As An Add-On Therapy With Standard of Care In Mild And Moderate Covid-19 Positive Patients | A Study To Assess Efficacy And Safety Of Polyherbal Formulation (COVI-RB01) As An Add-On Therapy With Standard of Care In Mild And Moderate Covid-19 Positive Patients - COVI-RB01 | | Alakart Bio Pharma Pvt Ltd | 20-10-2021 | 20211020 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59706 | Recruiting | No | | | | 23-10-2021 | 130 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 2/ Phase 3 | India | Sudarshan Behera | | Alakart Bio Pharma Pvt. Ltd. Office
1st floor, 1-98-9 3 9 & 10. Plot No. 25 & 26 1st floor, Madhapur, Hyderabad | drprashantkhade@gmail.com | | Dr D. Y. Patil College of Ayurveda Hospital and Research Centre | Inclusion criteria: - RT-PCR based diagnosis of COVID-19 <br/ ><br>- Treatment trials: cases of mild and moderate severity. <br/ ><br>- Willingness to participate. | Exclusion criteria: - Severe category (Spo2 < 90). <br/ ><br>- Individuals with uncontrolled, unstable co-morbidities. <br/ ><br>- Individuals with pre-existing respiratory conditions. Immuno-compromised individuals or those on immuno-suppressants. <br/ ><br>- Pregnant and lactating females. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | - Two Point recovery on 10-point WHO Ordinal Scale. <br/ ><br>- Time to Clinical ImprovementTimepoint: During regimen and upto 14 days | | | | Yes | False | | |
| +++ | CTRI/2021/10/037379 | 8 November 2021 | A study to assess the role of Oral microbiome and mucosal immunity in COVID-19 disease | Role of Oral microbiome and mucosal immunity in COVID-19 disease: diagnostic and prognostic utility in south asian populations(MIMSA) - MIMSA | | Department of Bio Technology | 20-10-2021 | 20211020 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=56297 | Not Recruiting | No | | | | 25-10-2021 | 1000 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:An Open list of random numbers Blinding and masking:Not Applicable | N/A | India;United Kingdom | DrNKumarasamy | | VHS Infectious Diseases Medical Centre, First Floor , IDMC Block, Voluntary Health Services, Rajiv Gandhi Salai, Taramani, Chennai -600113 | kumarasamy@cartcrs.org | 09176712007 | VHS Infectious Diseases Medical Centre | Inclusion criteria: -Willing to participate and provide blood and saliva samples at stipulated time points <br/ ><br>-Healthy Controls: No history of COVID-19, not vaccinated, negative for anti-SARS-CoV2 nucleoprotein antibodies <br/ ><br>-Asymptomatic / symptomatic participants: NPS-positive by RT-PCR; disease severity <br/ ><br>graded as per NIH guidelines | Exclusion criteria: -Critically ill participants who cannot give informed consent <br/ ><br>-Those who are not willing to get an oral examination done <br/ ><br>-Those who cannot chew / drool to provide a SWMF sample due to severe/critical conditions <br/ ><br>-Participants with known malignancies and pregnancies <br/ ><br>-Participants who are on long-term immunosuppressants like those with autoimmune <br/ ><br>diseases | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | mucosal immunity, as reflected in the oral cavity/oropharynx <br/ ><br>and the oral microbiome play a critical role in susceptibility and severity of COVID-19Timepoint: Day 0, 10-14, 30, 90 | | | | Yes | False | | |
| +++ | CTRI/2021/10/037380 | 8 November 2021 | Clinical Study on Nichi Glucan to Verify Effectiveness on Covid19 | An Open Label, Prospective, Randomized, Comparative, Multiple Arm Clinical Study to Evaluate the Immunomodulatory Efficacy of Nichi Glucan in Comparison with Conventional Therapeutic Regimen in Adult Subjects with Covid-19 caused by SARS-COV2 (B-COV) | | NichiIn Bio Sciences Pvt Ltd | 20-10-2021 | 20211020 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61522 | Not Recruiting | No | | | | 25-10-2021 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | Phase 3 | India | Gurunathan K S | | Department of Immunology,
No 69, Anna Salai Rd
Guindy
Chennai | pushkala.s@tnmgrmu.ac.in | 9940223180 | The Tamil Nadu Dr. MGR Medical University | Inclusion criteria: 1. Adult subjects between 18 and 65 years -both ages and sexes-inclusive- who are confirmed to be positive for SARS-CoV2 by way of RT-PCR in a laboratory approved by MoH-FW and the State Government. <br/ ><br>2. Patients with co-morbidities can be included. <br/ ><br>3. Patients who are found to be Covid19 positive requiring hospitalization. -Symptomatic or asymptomatic- <br/ ><br>4. Patients and LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period. <br/ ><br>5. Patients who are willing not to participate in any other clinical trial during participation in the current trial. <br/ ><br> | Exclusion criteria: 1. Patients who are known to be HIV, HBV, HCV positive. <br/ ><br>2. Patients who have clinically abnormal renal or hepatic function values that are 3x times normal upper limit or in the opinion of the Investigator would impact the objectives of the study. <br/ ><br>3. Patients with complete cancer remission less than 3 years prior to the date of screening. <br/ ><br>4. Patients who have undergone major surgical procedure 4 weeks prior to randomization. <br/ ><br>5. Patients who are on anti-depressants, anti-psychotics. <br/ ><br>6. Patients with known history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases; expect those that are considered etiology of said indication <br/ ><br>7. Females who are pregnant or nursing or planning to become pregnant during the study period. | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Nichi Glucan and Conventional Therapy: Dose<br> Nichi Glucan -AFO-202- 1 g <br>Nichi Glucan Refix -N-163-10g <br><br>Dosage<br>Nichi Glucan -AFO-202- 1 g sachets thrice daily with meals<br>Nichi Glucan Refix -N-163-10g gel sachet once daily<br><br>Treatment Duration - 60 days<br><br>Route of Administration - Oral<br><br>Control Intervention1: None: None. Conventional Therapy to be used<br> | 1. Immunology: IL-2, IL6, IgA <br/ ><br>2. Hospitalisation: Mortality, Duration of hospital stay, Need for Oxygen or Life-support <br/ ><br>3. Blood Test :Complete blood count â??CBC-, D-Dimer, C-reactive protein â??CRP-, Erythrocyte Sedimentation rate â??ESR-, Fasting â??FBG- and post-prandial â??PPG- blood glucose, HbA1C, Lipid profile, Liver function test, Ferritin <br/ ><br>Timepoint: Day 0, Day 7, Day 15, Day 30, Day 60 | | | | Yes | False | | |
| +++ | CTRI/2021/10/037381 | 8 November 2021 | Clinical characteristics of Moderate category COVID-19 patients. | Clinico-Laboratory and Radiological characteristics of Moderate category COVID-19 patients. | | Maulana Azad Medical College | 20-10-2021 | 20211020 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61769 | Not Recruiting | No | | | | 25-10-2021 | 40 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Sachin Gautam | | Department of General Medicine ,B L Taneja block, Lok Nayak Hospital, Maulana Azad Medical College, Bahadurshah Zafar Marg ,New Delhi-110002 | bhadoriadp@hotmail.com | 9315130033 | Maulana Azad Medical College | Inclusion criteria: 1. Laboratory confirmed COVID-19 positive (By RT-PCR or Rapid Antigen Test) patients <br/ ><br>that come under moderate category of clinical severity as per Government of India Ministry <br/ ><br>of Health and Family Welfare Directorate General of Health Services28of age â?¥18 years <br/ ><br>and of either sex. <br/ ><br>2. Suspect COVID-19 patients who turn out to be laboratory confirmed COVID-19 positive <br/ ><br>(By RT-PCR or Rapid Antigen Test) and fall under moderate category of clinical severity. | Exclusion criteria: Females with pregnancy. | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Control Intervention1: NIL: NIL<br> | Correlation between clinical, laboratorial and radiological characteristics <br/ ><br>of moderate category COVID-19 patients will be studied.Timepoint: At Baseline | | | | Yes | False | | |
| +++ | CTRI/2021/10/037412 | 8 November 2021 | Study of Covid-19 among staff in a Medical College | Impact of vaccination on Covid-19 among staff of a rural tertiary care center in Kerala: A retrospective longitudinal cohort study | | Malankara Orthodox Syrian Church Medical College | 20-10-2021 | 20211020 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61973 | Not Recruiting | No | | | | 01-11-2021 | 200 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Abraham Ittyachen M | | Department of Medicine
Malankara Orthodox Syrian Church Medical College
Kolenchery
Ernakulam District
KERALA - 682311
India | abyliz@rediffmail.com | 9447291662 | Malankara Orthodox Syrian Church Medical College | Inclusion criteria: All health care workers who developed Covid-19 between 1st Jan 2020 and 31st Dec 2021. | Exclusion criteria: Patients who refuse to be part of the study. | Health Condition 1: U071- COVID 19 virus identified
Health Condition 2: Z768- Persons encountering health services in other specified circumstances
| Control Intervention1: Nil (Observation study): Nil (Observation study)<br> | 1. To find the incidence of Covid-19 in health care workers who were not vaccinated, those who received one dose of vaccination and those who received two doses of vaccination. <br/ ><br>2. To find if there is any association of age and gender with Covid-19 (in both vaccinated and non-vaccinated). <br/ ><br>3. To study the association of interval between two doses of vaccination and Covid-19. <br/ ><br>4. To study the association of co-morbidities (diabetes, hypertension, etc..) with Covid-19. <br/ ><br>5. In study the association of vaccination and severe Covid-19 disease (ICU admission, oxygen requirement). <br/ ><br>6. To study the proportion of side effects of vaccination. <br/ ><br>Timepoint: 1Nov2021 â?? 31Jan2022 | | | | Yes | False | | |
| +++ | CTRI/2021/10/037422 | 8 November 2021 | Home Based Rehabilitation On Cardio-Respiratory Fitness In Post Covid-19 Type II Diabetes Mellitus Patients-Randomized Controlled Trail | Effect of home based rehabilitation program on
cardio-respiratory fitness level with post
COVID-19 patients in type II Diabetes
Mellitus-Randomized controlled trial | | MGM Institute Of Physiotherapy | 21-10-2021 | 20211021 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59552 | Not Recruiting | No | | | | 22-10-2021 | 70 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Open Label | Phase 2 | India | DR MANISH SHUKLA | | MGM Institute of Physiotherapy,
Cardio-Respiratory Department,
N 6, CIDCO, Aurangabad MGM Institute of Physiotherapy,
Cardio-Respiratory Department,
N 6, CIDCO, Aurangabad | manish.shukla20@gmail.com | 9960290614 | MGM INSTITUTE OF PHYSIOTHERAPY | Inclusion criteria: Post COVID patients who have been medically diagnosed with <br/ ><br>type 2 DM. <br/ ><br>Age 40-50 years <br/ ><br>Post COVID patients who had mild infection, successfully <br/ ><br>recovered and tested negative. (Negative RT â?? PCR ) <br/ ><br>Patients with normal BMI (18. 5 â?? 24.9) <br/ ><br>Both males and females | Exclusion criteria: Patients who had history of ICU stay who were ventilated for <br/ ><br>prolong period of time. <br/ ><br>Patients who are had the history of chronic diabetes mellitus. <br/ ><br>Patients suffering from diabetic retinopathy, diabetic <br/ ><br>nephropathy, diabetic neuropathy, fractures. <br/ ><br>Pregnant women and women who are lactating | Health Condition 1: E119- Type 2 diabetes mellitus without complications
| Intervention1: HOME BASED REHABILITATION PROGRAM: mild to moderate physical activity which will involve 15<br>minutes of brisk walking, step up and step down for 5 minutes, spot<br>marching for 5 minutes and stair climbing- 2 flights<br>Control Intervention1: GROUP A- EXPERIMENTAL GROUP- Physical activity like brisk walking, stair climbing, spot marching, healthy diet, lifestyle modifications<br><br>GROUP B - CONTROLLED GROUP- Daily routine activity, lifestyle modifications, healthy diet.: patients will be performing the activity for 30 minutes / day along<br>with which they will be doing 10 min warm up exercises (arm<br>circles, side shuffles, spot marching) prior to the activity and 10 min<br>cool down exercises ( stretching ) after the activity.<br>Mild to moderate intensity exercise for 3-5 days per week for 150 min per week<br> | VO2 MAX <br/ ><br>6 MINUTES WALK TEST <br/ ><br>Timepoint: AT BASELINE <br/ ><br>ON 4TH WEEK <br/ ><br>ON 8TH WEEK | | | | Yes | False | | |
| +++ | CTRI/2021/10/037423 | 8 November 2021 | Evaluation of an Ayurvedic formulation in clinical recovery of COVID-19 infected patients: A double blind randomized study | A randomized, double blind, placebo controlled, multi-centric, trial to determine the therapeutic efficacy of Ayush medicine NF2 in treatment of symptomatic COVID-19 patients along with standard allopathic treatment - NF2study | | Sriveda Sattva Private Limited | 21-10-2021 | 20211021 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61805 | Not Recruiting | No | | | | 27-10-2021 | 100 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3/ Phase 4 | India | DR ABHISHEK ARUN | | Room No: 4, H/4 Sector-e Amarpali Yojana IIM - Dubagga Road opp- Dubagga Power House Dubagga - Lucknow | dr.abhishekarun@gmail.com | 9889441902 | Atharva Multispecialty Hospital and Research Center | Inclusion criteria: Age 21 to 75 years <br/ ><br>b) Symptomatic COVID-19 infected patients with or without comorbidities <br/ ><br>c) Reported to OPD within three days of onset of symptoms <br/ ><br>d) Willing to take AYUSH treatment | Exclusion criteria: Not willing to give consent/ participate in the clinical trial <br/ ><br>b) Age less than 18 years or more than 75 years <br/ ><br>b) Patients with chronic comorbidities like diabetes, chronic heart conditions and HIV/AIDS <br/ ><br>c) Pregnant and Lactating mothers <br/ ><br>d) Patients on immunosuppressive therapy <br/ ><br>e) SARS-CoV-2 infected patients with oxygen saturation less than 90% or those in ICU | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | The patients were assessed for improvement from COVID-19 based on their RT-PCR negative results. The primary outcome was the rate of recovery based on viral load reduction, RT-PCR negativity rate.Timepoint: DAy 0,7, 10,14 | | | | Yes | False | | |
| +++ | CTRI/2021/10/037424 | 8 November 2021 | To find out the rate of infection among vaccinated delegates post a medical conference held with all the safety precautions | BREAKTHROUGH INFECTIONS OF COVID-19 IN VACCINATED DELEGATES POST A MEDICAL CONFERENCE CONDUCTED WITH SAFE MANAGEMENT | | ICMR | 21-10-2021 | 20211021 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61972 | Not Recruiting | No | | | | 28-10-2021 | 385 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Dr Ramesha Bhat M | | Department Of Dermatology,
Father Muller Medical College Hospital, Kankanady,
Mangalore
| rameshderma@fathermuller.in | | FATHER MULLER MEDICAL COLLEGE | Inclusion criteria: 1. All the completely vaccinated delegates attending the conference. <br/ ><br>2. Delegates willing to take part in the study. <br/ ><br> | Exclusion criteria: 1. Non-vaccinated delegates. <br/ ><br>2. Delegates unwilling to take part in the study. <br/ ><br>3. Delegates who feel unwell. <br/ ><br>4. Children <18 years <br/ ><br>5. COVID-19 RT-PCR Positive. <br/ ><br> | | | To follow up and assess the rate of infection among vaccinated delegates with COVID-19, 15 days post the conference.Timepoint: To follow up and assess the rate of infection among vaccinated delegates with COVID-19 on spot and 2 weeks post the conference. <br/ ><br>Time points: <br/ ><br>0 day (day 1 of conference) <br/ ><br>2 weeks (day 15 post conference) | | | | Yes | False | | |
| +++ | CTRI/2021/10/037442 | 8 November 2021 | Ayurvedic formulation in the management of COVID patients in rural India | A Randomized double blind placebo controlled, multi-centric, trial to determine the therapeutic efficacy of AYUSH medicine NOQ19 in treatment of symptomatic COVID-19 patients along with standard allopathic treatment | | Sriveda Sattva Pvt Ltd | 21-10-2021 | 20211021 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61697 | Not Recruiting | No | | | | 01-11-2021 | 100 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:On-site computer system Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded | Phase 3/ Phase 4 | India | Saumya Subramanian | | Room No:1, First Floor, Research Department, SSIAR, Bangalore, Karnataka | saumya.subramanian@ssiar.org | | Sri Sri Institute for Advanced Research | Inclusion criteria: Symptomatic COVID-19 Infection with or without comorbidities. <br/ ><br>Willingness to participate in the Study <br/ ><br>Indian Nationals | Exclusion criteria: Age less than 18 years and age above 65 years. <br/ ><br>Patients not willing to participate in the study. <br/ ><br>Pregnancy and Lactation | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | Rate of recovery as measured by RT-PCRTimepoint: Baseline, <br/ ><br>Day3, <br/ ><br>Day7, <br/ ><br>Day 10 | | | | Yes | False | | |
| +++ | CTRI/2021/10/037460 | 8 November 2021 | Comparative Evaluation of alternative kits required for RTPCR testing in diagnosis of COVID-19 illness | Clinical validation of 1) VereRTâ?¢ COVID-19 PCR Kit using RNA extracted from SARS-CoV-2 in nasopharyngeal swab collected from both left and right nostrils as specimen type in VTM; 2) VereRTâ?¢ ZeroPrepâ?¢ COVID-19 PCR Kit testing two sample matrices: direct testing from nasopharyngeal swab collected from both left and right nostrils in VTM as specimen type, and direct testing from human saliva (collected by using ZeroPrepâ?¢ Saliva Collection Kit) - NA | | Veredus Laboratories Pte Ltd | 21-10-2021 | 20211021 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62086 | Not Recruiting | No | | | | 01-11-2021 | 900 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Vinay Onkar | | Clinical Development Services ,1st Floor,Plot No - A-77, Accutest Research Laboratories (I) Pvt.Ltd.
MIDC,TTC Industrial Area, Khairane Navi Mumbai-400709
| prashant.basapure@accutestglobal.com | 02227780718 | ACCUTEST RESEARCH LABORATORIES (I) PVT LTD | Inclusion criteria: Inclusion Criteria For COVID-19 Positive Patients <br/ ><br> <br/ ><br>1.Patients with 18 years age or older of either gender with confirmed RT-PCR positive result for COVID-19 illness. <br/ ><br>2.Close contacts of known COVID positive case with 18 years age or older of either gender found RT-PCR positive result for COVID-19 illness. <br/ ><br>3.Confirmed hospitalized patients for COVID-19 illness with 18 years age or older of either gender. <br/ ><br>4.Home quarantined patients with confirmed RT-PCR positive result for COVID-19 illness with 18 years age or older of either gender. <br/ ><br>5.Individuals with 18 years age or older of either gender undergoing RT-PCR testing for COVID-19 illness for any other reason and found positive. <br/ ><br>Inclusion Criteria For COVID-19 Negative Subjects <br/ ><br>1.Apparently healthy and asymptomatic subjects with 18 years age or older of either gender. <br/ ><br>2.Close contacts of known COVID positive case with 18 years age or older of either gender undergoing COVID RT-PCR testing and found negative. <br/ ><br>3.Individuals 18 years age or older of either gender undergoing RT-PCR testing for COVID-19 illness for any other reason and found negative. <br/ ><br> <br/ ><br> | Exclusion criteria: Exclusion Criteria For COVID-19 Positive and negative participants <br/ ><br> <br/ ><br>1.Patients where it is impossible/unsafe to obtain the required research samples. <br/ ><br>2.Vulnerable population (critically ill, children, prisoners, etc). <br/ ><br>3.Patients who deny to sign written informed consent to participate in the study. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | 1. To estimate sensitivity of new COVID-19 illness diagnostic kits <br/ ><br>2. To estimate specificity of new COVID-19 illness diagnostic kitsTimepoint: One time assessment will be done within 5 days of biological sample collection | | | | Yes | False | | |
| +++ | CTRI/2021/10/037465 | 8 November 2021 | Comparison of blood profile with mortality in covid 19 patients | Association of electrolyte imbalance ,coagulopathy ,procalcitonin and mortality in patients with SARS-CoV-2 | | Yenepoya Medical College | 22-10-2021 | 20211022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61064 | Not Recruiting | No | | | | 22-10-2021 | 106 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Aleena Varughese | | Department Of Biochemistry
Yenepoya Medical College
University,road,deralakatte
Mangaluru | drgreesh83@gmail.com | 7561886014 | Yenepoya Medical College and Hospital | Inclusion criteria: Patients tested covid positive by RTPCR. | Exclusion criteria: Patients tested negative by RTPCR. | Health Condition 1: R791- Abnormal coagulation profile
Health Condition 2: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 3: R99- Ill-defined and unknown cause of mortality
| Intervention1: NOT APPLICABLE: NOT APPLICABLE<br> | comparison of mortality with elecrtolyte imbalance,coagulation profile and procalcitoninTimepoint: Outcome will be assessed second week of November | | | | Yes | False | | |
| +++ | CTRI/2021/10/037466 | 8 November 2021 | To assess predisposing factors in patients of mucormycosis following COVID infection at a tertiary hospital in North India | Epidemiological analysis in patients of Mucormycosis at a tertiary care center in North India | | NITIKA BERI | 22-10-2021 | 20211022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=58818 | Not Recruiting | No | | | | 30-10-2021 | 70 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | NITIKA BERI | | Room Number 510, Department of Ophthalmology, University College of Medical Sciences and GTB Hospital | berinitika@gmail.com | 9871130760 | University College of Medical Sciences and GTB Hospital | Inclusion criteria: Patients with Mucormycosis admitted at the tertiary care center | Exclusion criteria: Patients without Mucormycosis admitted at the hospital and patients who do not give consent to be a part of the study. | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B463- Cutaneous mucormycosis
Health Condition 3: B464- Disseminated mucormycosis
Health Condition 4: B465- Mucormycosis, unspecified
Health Condition 5: B461- Rhinocerebral mucormycosis
| | To assess predisposing factors for MucormycosisTimepoint: At baseline | | | | Yes | False | | |
| +++ | CTRI/2021/10/037467 | 8 November 2021 | A cluster randomized trial of ActeevTM system compared with standard system to prevent Severe Acute Respiratory Syndrome Coronavirus 2 in health care workers. | A cluster randomized trial of ActeevTM system, (ActeevTM N95 masks YQD8008 during the shifts plus ActeevTM fabric masks in community) compared with the standard system, (standard N95 masks during shifts plus fabric masks in community) in preventing Severe Acute Respiratory Syndrome Coronavirus 2 (SARS CoV-2) in health care workers. | | Ascend Performance Materials Operations LLC | 22-10-2021 | 20211022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61878 | Not Recruiting | No | | | | 31-10-2021 | 1600 | Interventional | Cluster Randomized Trial<br> Method of generating randomization sequence:Other Method of allocation concealment:Not Applicable Blinding and masking:Open Label | N/A | India | Dr Vikram Gopal | | Ascend Performance Materials Operations LLC, 1010 Travis Street, Suite 900, Houston, Texas 77002, United States | VGopal@ascendmaterials.com | | Ascend Performance Materials Operations LLC | Inclusion criteria: A subject will be considered eligible for inclusion in this study only if ALL of the following criteria apply: <br/ ><br>1.Health care workers and allied health care staff working in COVID wards, COVID ICU, Non COVID ICU (This will include all specialty ICUs in the hospital), Casualty/Emergency, Operation Theatre and Pathology lab of the hospital to be considered for recruitment. <br/ ><br>2.Health care workers and allied health care staff involved in performing high risk procedures like suctioning, intubation, nebulized medications, chest physiotherapy, other aerosol generating procedures and handling pathology samples to be considered for recruitment <br/ ><br>3.Negative COVID 19 RT-PCR test within last 3 days of screening <br/ ><br>4.COVID 19 vaccinated or non-vaccinated. <br/ ><br> | Exclusion criteria: A subject will not be eligible for inclusion in this study if ANY of the following criteria apply: <br/ ><br>1.Unable or refused to consent <br/ ><br>2.Current respiratory illness, rhinitis and/or allergy <br/ ><br>3.Currently participating in any other clinical trial <br/ ><br>4.Beard or facial hair <br/ ><br> | | Intervention1: ActeevTM system which includes ActeevTM N95 masks YQD8008 during shifts and ActeevTM fabric masks in community.: Participants in Arms 1 will wear ActeevTM N95 masks YQD8008 during 8-hour shift for 8 (or 12) consecutive weeks and ActeevTM fabric masks for community use for 8 (or 12) consecutive weeks. On completion of desired period of mask usage participants will be followed up for 2 weeks in the absence of test mask usage<br><br>Control Intervention1: Standard system which includes standard N95 masks during shifts and fabric masks in community: Participants in arm 2 wear standard N95 masks during 8-hour shift for 8 (or 12) consecutive weeks and fabric mask for community use for 8 (or 12) consecutive weeks. On completion of desired period of mask usage participants will be followed up for 2 weeks in the absence of test mask usage.<br> | Number of cases with laboratory-confirmed for viral SARS CoV 2 respiratory infection using RT-PCR with or without two or more respiratory symptoms or one respiratory symptom and/or a systemic symptomTimepoint: Test will be repeated every 2 weeks to identify the number of cases with SARS CoV 2 infection | | | | Yes | False | | |
| +++ | CTRI/2021/10/037468 | 8 November 2021 | Role of commonly used blood pressure medications in treatment of COVID-19 (CLARITY 2.0) | An Investigator Initiated, International Multi-Centre, Multi-Arm, Multi-Stage Randomised Double Blind Placebo Controlled Trial of Angiotensin Receptor Blocker (ARB) and Chemokine Receptor Type 2 (CCR2) Antagonist for the treatment of COVID-19 - CLARITY 2.0 | | The University of Sydney | 22-10-2021 | 20211022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=51638 | Not Recruiting | No | | | | 01-11-2021 | 600 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Adaptive randomization, such as minimization Method of allocation concealment:On-site computer system Blinding and masking:Participant and Investigator Blinded | Phase 2/ Phase 3 | India | Dr Vivekanand Jha | | 308-309 (Room Number), Office of the Executive Director (Department & Division), Third Floor, Elegance Tower, Plot No. 8, Jasola District Centre 308-309 (Room Number), Office of the Executive Director (Department & Division), Third Floor, Elegance Tower, | vjha@georgeinstitute.org.in | 911141588091 | George Institute for Global Health | Inclusion criteria: 1.Adults aged â?¥ 18 years <br/ ><br>2.Laboratory-confirmed diagnosis of SARS-CoV-2 infection within 10 days prior to randomisation (Confirmation through appropriate approved laboratory or Point of Care testing method, including Polymerase Chain Reaction (PCR) or other public health assay.) <br/ ><br>3.Systolic Blood Pressure (SBP) â?¥ 120 mmHg OR SBP â?¥ 115 mmHg and currently treated with a non-RAASi BP lowering agent that can be ceased. <br/ ><br>4.Willing and able to comply with all study requirements, including treatment, timing and/or nature of required assessments. <br/ ><br>5.Documented informed consent <br/ ><br> | Exclusion criteria: 1.Currently treated with an ACEi, ARB or aldosterone antagonist, aliskiren, or ARNi <br/ ><br>2.Intolerance of ARBs <br/ ><br>3.Serum potassium >5.5 mmol/L <br/ ><br>4.An estimated Glomerular Filtration Rate (eGFR) <30ml/min/1.732m <br/ ><br>5.Known biliary obstruction, known severe hepatic impairment (Child-Pugh-Turcotte score 10-15) <br/ ><br>6.Pregnancy, lactation, or inadequate contraception. <br/ ><br>o Female participants must be either post-menopausal, infertile or use a reliable means of contraception for at least 60 days after the last dose of investigational product or refrain. Where they are of childbearing potential, female participants must also have a negative pregnancy test result within 7 days prior to registration. <br/ ><br>o Male participants must have been surgically sterilised or use a (double if required) barrier method of contraception during the treatment period and for at least 60 days after the last dose of investigational product or refrain from donating sperm during this period. <br/ ><br>7.Participation in a study of a novel investigational product within 28 days prior to randomisation. <br/ ><br>8.Plans to participate in another study of a novel investigational product during this study. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Dual therapy of candesartan and Repagermanium.: Oral candesartan 4mg twice daily for 28 days + Repagermanium 120mg immediate release capsule twice daily for 28 days<br>Control Intervention1: Candesartan ARB and placebo repagermanium: Oral candesartan 4mg twice daily for 28 days plus placebo twice daily for 28 days<br>Control Intervention2: Placebo candesartan ARB plus placebo repagermanium: placebo twice daily for 28 days<br> | The primary endpoint is a Clinical Health Score, determined within a 7-point ordinal scale of clinical health status which is a modified version of the 9-point score developed by the WHO for Coronavirus Disease 2019 (COVID-19) trials.Timepoint: Day 1-14 <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/10/037479 | 8 November 2021 | Effect of chyawanprash on immune system when administered after covid-19 vaccination in health care personnel | The impact of chyawanprash on immunogenicity when administered after covid-19 vaccination in health care personnel - an open-label, prospective randomized controlled study - ECIVHCP | | Central Council for Research in Ayurvedic Sciences | 22-10-2021 | 20211022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61862 | Not Recruiting | No | | | | 08-11-2021 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:An Open list of random numbers Blinding and masking:Open Label | N/A | India | Dr R Govind Reddy | | room no 02, Technical department, Regional ayurveda research institute, near gharkul parisar, nandanwan, nagpur, maharashtra | drrgreddy68@gmail.com | | Researcher, CCRAS | Inclusion criteria: 1.All healthcare professionals and staff of age group between 25 to 60 years, after 14 days of 2nd dose of COVID-19 vaccine (COVISHIELD), negative for SARS- Cov-2 at screening, (tested by rt-PCR), at DMIMS, without co-morbid condition or stable with ongoing medications, with exposure/chance of exposure to COVID 19 positive cases. <br/ ><br>2.Who is willing to provide signed informed consent <br/ ><br>High-Risk Group- It includes doctors, nursing staff, and other paramedical staff like attendants who are directly looking after and examining COVID patients. <br/ ><br>Low risk- other faculty members & hospital staff who are present in the institute but not visiting the corona ward. <br/ ><br> | Exclusion criteria: 1.Not vaccinated with COVID-19 vaccine (1st and 2nd dose). <br/ ><br>2. Pregnant and lactating females. <br/ ><br>3.Immune compromised cases. <br/ ><br>4.Laboratory confirmed COVID-19 with or without symptoms <br/ ><br>5. Known allergy to any of the medications used in this trial. <br/ ><br>6. Not willing to participate in the study. <br/ ><br>7. History of receiving any investigational drug in the preceding one month. <br/ ><br>8.Subjects who are taking any other medicine as prophylaxis such as HCQ or any other CAM (Complimentary Alternative Medicine) formulation in the preceding 1 month. <br/ ><br>9.Any condition or circumstances which in the opinion of the investigator may make a participant unlikely or unable to complete the study or comply with study procedures and requirements <br/ ><br> | | | Percentage of participants with SARS- Cov-2 positivity as estimated by RT-PCR of nasopharyngeal swab or by Chemiluminiscenceassay during the study duration.Timepoint: 6 months | | | | Yes | False | | |
| +++ | CTRI/2021/10/037502 | 8 November 2021 | Use of Ambroxol in patients with moderate COVID-19 disease. | A randomized, placebo controlled, double-blind study to evaluate the safety and efficacy of oral Ambroxol in hospitalized patients with COVID-19 - NIL | | ICMR | 22-10-2021 | 20211022 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61765 | Not Recruiting | No | | | | 31-10-2021 | 60 | Interventional | Randomized, Parallel Group, Placebo Controlled Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Sequentially numbered, sealed, opaque envelopes Blinding and masking:Participant and Investigator Blinded | N/A | India | Dr Nithya Gogtay | | Dept. of Clinical Pharmacology 1st Floor, New Building Seth GSMC
& KEM Hospital Parel.
Mumbai
MAHARASHTRA
400012
India | njgogtay@hotmail.com | 9820495836 | Seth GS Medical College & KEM Hospital, Parel, Mumbai-400012 | Inclusion criteria: Participants who are able to provide a written informed consent or have a legally accepted representative to provide the same. <br/ ><br>Participants who are between 18 years and 75 years of age. <br/ ><br>Participants who are proven to be positive for SARS-CoV-2 infection, as confirmed by the RT-PCR test. <br/ ><br>Participants who are admitted with moderate COVID-19 for treatment at the hospital. <br/ ><br>Female participants with a negative urine pregnancy test at screening. <br/ ><br>Participants who are able to take the study drug orally and comply with the study procedures. <br/ ><br> | Exclusion criteria: Participants who are participating in any other clinical trial or experimental treatment for COVID-19. <br/ ><br> <br/ ><br>Participants with pre-existing respiratory illness. <br/ ><br> <br/ ><br>Participants with persistent vomiting (more than three episodes of vomiting in 12 hours) and who cannot tolerate oral drugs. <br/ ><br> <br/ ><br>Participants requiring concomitant use of invasive or non-invasive mechanical ventilation. <br/ ><br> <br/ ><br>Participants requiring vasopressors or ionotropic medications. <br/ ><br> <br/ ><br>Female Participants who are lactating. <br/ ><br> <br/ ><br>Participants who are known to be HIV positive or positive for Hepatitis B or C. (The same may be noted based on history given by the subject or standards of care followed at the individual sites.) <br/ ><br> <br/ ><br>Participants who are not deemed fit as per the investigator or his/her team for any other medical reason. <br/ ><br> <br/ ><br>Past history of allergy to Ambroxol. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Ambroxol 30 mg two tablets: Ambroxol 30 mg two tablets TDS for 14 days or till discharge whichever is earlier with Standard of care<br>Control Intervention1: Matching Placebo: Matching Placebo 2 tablets TDS for 14 days or till discharge whichever is earlier with Standard of care<br> | Proportion of patients showing clinical improvement: Clinical improvement is defined as the patients meeting the discharge criteria or a 2-point improvement in the disease severity on the 8-point ordinal scale (Annexure 3). Discharge criteria includes resolution of clinical symptoms, biochemical tests or radiological improvement, as per discretion of the Investigator.Timepoint: Baseline and days 3,7 and 10 or at discharge. | | | | Yes | False | | |
| +++ | CTRI/2021/10/037514 | 8 November 2021 | Ferritin as a Marker of Severity in Covid 19 Patients | Retrospective Study to assess Ferritin as a marker of severity in Covid 19 patients - Ferritin in Covid 19 | | Dr TMA PAI HOSPITAL | 25-10-2021 | 20211025 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=60594 | Not Recruiting | No | | | | 30-10-2021 | 128 | Observational | Other<br> Method of generating randomization sequence:Other Method of allocation concealment:Case Record Numbers Blinding and masking:Not Applicable | Phase 3/ Phase 4 | India | Dr ROHITH KUMAR | | Dr TMA PAI HOSPITAL,
Ajjarkad, Udupi Icon Appartment
B block, Room NO: 401
Ajjarkad, Udupi
| drshettyseema@yahoo.com | 9845856769 | Dr TMA PAI Hospital | Inclusion criteria: 1)Lab confirmed COVID 19 by RT-PCR test <br/ ><br>2)Patients admitted between APRIL 2020 to <br/ ><br>APRIL 2021 <br/ ><br>3) > 16 years of Age <br/ ><br>4)Duration of Admission more than 7 days <br/ ><br> | Exclusion criteria: 1)COVID -19 RT-PCR Negative <br/ ><br>2) < 16 Years of Age <br/ ><br>3)Pregnancy <br/ ><br>4)Duration of Admission Less than 7 days <br/ ><br>5)Patients with prior Renal failure, chronic inflammatory disorders like (RA, Autoimmune disorders, Inflammatory bowel disease, Malignancy) <br/ ><br>6)Patients with other infections either preexisting or diagnosed secondary infections after admission | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: B338- Other specified viral diseases
| Control Intervention1: Retrospective study to assess Ferritin as a Marker of Severity in Covid 19 Patients<br>: NIL<br> | correlation of serum ferritin levels with severity of COVID 19 illness (Severe versus Non-Severe Covid 19)Timepoint: APRIL 2020 to APRIL 2021 | | | | Yes | False | | |
| +++ | CTRI/2021/10/037515 | 8 November 2021 | Chest computed tomography severity scoring and its relation with age and gender during second wave of covid 19 pandemic. | Chest computed tomography severity scoring and its relation with age and gender during second wave of covid 19 pandemic - A retrospective observational study. | | Bikash Parida | 25-10-2021 | 20211025 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=59569 | Not Recruiting | No | | | | 24-11-2021 | 650 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Bikash Parida | | Department of Radiology, IMS and SUM Hospital, Kalinganagar, Bhubaneswar, Odisha, India | bikashparidascbmc@gmail.com | 9437207244 | IMS and SUM Hospital | Inclusion criteria: Confirmed cases of covid 19 (RTPCR positive or CORADS 6) patients coming to radiology department of IMS and SUM Hospital for HRCT Thorax. | Exclusion criteria: RTPCR negative patients. | Health Condition 1: -
Health Condition 2: J989- Respiratory disorder, unspecified
| Intervention1: Nil: Nil<br> | To establish relation of CT severity with age and gender during second wave of Covid 19Timepoint: 4 weeks | | | | Yes | False | | |
| +++ | CTRI/2021/10/037516 | 8 November 2021 | Effect of specific yoga module to manage covid stress among youths | Adopting specific yoga module to reduce the burden of post COVID stress disorder among unemployed youth and recent graduates: a pilot investigative study | | Department of Science Technology Science And Technology of Yoga And Meditation | 25-10-2021 | 20211025 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=55325 | Not Recruiting | No | | | | 01-12-2021 | 100 | Interventional | Randomized, Parallel Group, Active Controlled Trial<br> Method of generating randomization sequence:Permuted block randomization, fixed Method of allocation concealment:On-site computer system Blinding and masking:Not Applicable | N/A | India | Ashwini K | | National Institute of Mental Health and Neurosciences, Department of Neurophysiology, Administrative Block
Hosur Road, Near Bangalore Milk Dairy | saumya.subramanian@ssiar.org | 9916127792 | Junior Research Fellow/ DST | Inclusion criteria: 1. COVID negative Subjects with history of COVID related stress, job loss/searching a job <br/ ><br>2. Severity of anxiety- low to moderate and confirmed by a HAM-A score < 10, requiring no medications <br/ ><br>3. Subjects who will consent for and be co- <br/ ><br>operative for the study. | Exclusion criteria: Subjects with suicidal tendency/thoughts <br/ ><br>1. Subjects with other psychotic disorders <br/ ><br>2. Subjects having cardiovascular problems <br/ ><br>3. Any neurological disorders such as any significant head injury, epilepsy, Parkinsonâ??s disease, neuro-degenerative disorders etc. <br/ ><br>4. Subjects of substance use disorders <br/ ><br>5. Pregnant and lactating women <br/ ><br>6. Any medical conditions that can mimic anxiety disorders like hyperthyroidism | | Intervention1: Sudarshan Kriya: Sudarshan Kriya is a technique taught by the Art of Living Foundation in more than 156 countries with more than 6 million practitioners across the globe. It is taught in various modules across various age groups in different parts of the world. <br>SKY is a cyclic rhythmic breathing technique with its roots in traditional yoga. The 25 minutes process includes three yogic components â?? pranayama, Om chanting and Sudarshan Kriya. The pranayama is done using the Ujjayi breath. Ujjayi involves experiencing the conscious sensation of the breath touching the throat. This slow breathing technique is performed at a rate of 2â??4 breaths per minute (bpm). This technique improves lung capacity, allowing more air to pass through the lungs. â??Omâ?? is chanted three times with prolonged exhalation. Lastly, Sudarshan Kriya rhythmic breathing is done in two variations:- long SKY, which is done under Gurudev Sri Sri Ravishankarâ??s recorded instruction, and short SKY which can be done can be done at home taking slow (20 bpm), medium (40â??50 bpm), and fast (60â??80 bpm) breaths. The entire technique is done in a seated posture with eyes closed.<br>The given technique will be administered once every day for 30 minutes till 2 months<br><br>Control Intervention1: Control: Routine lifestyle<br> | To find the efficacy (if any) of yoga module on vulnerable population (people who lost <br/ ><br>their job and unemployed graduates)Timepoint: 0 Day, <br/ ><br>60 Day | | | | Yes | False | | |
| +++ | CTRI/2021/10/037527 | 8 November 2021 | Pregnancy outcomes with co-existing COVID 19 infection and thyroid disorder | OBSTETRIC OUTCOME IN COVID 19 POSITIVE PREGNANT WOMEN WITH THYROID DYSFUNCTION | | MAULANA AZAD MEDICAL COLLEGE AND LOK NAYAK HOSPITAL | 25-10-2021 | 20211025 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62170 | Not Recruiting | No | | | | 01-11-2021 | 60 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Rathod Raj Vijaykumar | | Department of obstetric and gynecology, Gate no.2, Lok Nayak Hospital, Bahadur Shah Zafar Marg, New Delhi | latikasahu@gmail.com | 09968604400 | Maulana Azad Medical college | Inclusion criteria: 1. Pregnant women in third trimester/ delivered. <br/ ><br>2. Patient diagnosed with thyroid disorder. <br/ ><br>3. Singleton Pregnancy <br/ ><br> | Exclusion criteria: 1. Known Chronic medical disorders- Diabetes, Hypertension, Heart disease and other medical disorders | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: E00-E07- Disorders of thyroid gland
| Control Intervention1: NIL: NIL<br> | Maternal outcomes: Mode of delivery, Gestational age at delivery <br/ ><br> Perinatal outcomes: Apgar at 0,1 and 5 minutes, birth weight <br/ ><br>Timepoint: <br/ ><br> At the time of admission, at delivery and 1 week post delivery. <br/ ><br> | | | | Yes | False | | |
| +++ | CTRI/2021/10/037563 | 8 November 2021 | THE EFFICACY OF PVP-I GARGLES AND INTRANASAL INSTILLATION ON CHECKING THE PROGRESSION OF COVID 19 | TO ASSESS THE EFFICACY OF POVIDONE IODINE GARGLES AND INTRANASAL INSTILLATION ON CHECKING THE PROGRESSION OF THE COVID-19 DISEASE AND VIRAL LOAD - A PROSPECTIVE RANDOMISED AND CONTROLLED STUDY | | DR S P AMBESH | 26-10-2021 | 20211026 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61807 | Not Recruiting | No | | | | 28-10-2021 | 100 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | DR ANUSREE EV | | MRA A61
SGPGIMS CAMPUS,LUCKNOW SGPGIMS
RAE BARELI ROAD
LUCKNOW
226014 PIN | anusree442@gmail.com | 9446624218 | SGPGIMS,LUCKNOW | Inclusion criteria: COVID 19 positive by RT PCR analysis of nasopharyngeal/oropharyngeal specimens <br/ ><br> Patients admitted with mild COVID 19 infection with or without co morbidities. <br/ ><br> | Exclusion criteria: Patients with tachypnoea <br/ ><br> Patients with SpO2less than 94% on room air <br/ ><br> Patients requiring oxygen supplementation or assisted ventilation at admission. <br/ ><br> Patients receiving antiviral agents <br/ ><br> Patients with known sensitivity to PVP-I. <br/ ><br> Pregnant patients and patients with thyroid diseases. <br/ ><br> Patients who refuse or are incapable of giving consent <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
Health Condition 2: J988- Other specified respiratory disorders
| Intervention1: Betadine gargle and Nasal drops: Patients meeting inclusion and exclusion criteria will be identified and an informed, written consent will be obtained. The patients will randomly be allocated into 2 groups with the help of a computer-generated table of random numbers:<br>Group 1: Standard treatment + intranasal Povidone Iodine1%+gargles<br>Group 2: Standard treatment alone<br>A total of 200 patients will be recruited with 100 in group 1 and 100 in group 2. <br>Baseline characteristics will be recorded using the proforma. Patients in group 2 will be given standard treatment alone. Patients in Group 1 will receive intranasal Povidone Iodine 1% solution (Betadine 1%) 2 drops thrice daily along with gargles for 6 days along with standard care. The patientâ??s clinical parameters will be followed up daily. On day 7 following start of treatment, patient will undergo RTPCR testing from nasopharyngeal and oropharyngeal swabs with estimation of viral load as indicated by cycle time. The patient will continue to be followed up until discharge or death. The relevant investigations, clinical course, length of hospital stay, and outcomes will be recorded on the proforma. <br><br>Control Intervention1: nil: nil<br> | 1)To evaluate the efficacy of intranasal povidone iodine 1% solution and gargles in reducing the viral load of SARS CoV2 in nasopharynx of patients admitted with mild COVID 19 disease. <br/ ><br>2)To evaluate clinical course in patients with mild COVID 19 illness who were treated with PVP-I gargle and intranasal solution with respect to ,Progression of disease Radiological features Inflammatory markers <br/ ><br>Timepoint: At baseline,at 1 week | | | | Yes | False | | |
| +++ | CTRI/2021/10/037591 | 8 November 2021 | Use of Hemopurifier Device For The Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans. | Treatment of SARS-CoV-2 Virus Disease (COVID-19) in Humans with Hemopurifier Device | | Aethlon Medical Inc | 27-10-2021 | 20211027 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62233 | Not Recruiting | No | | | | 10-11-2021 | 15 | Interventional | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Sandeep Malik | | Qualtran LLC
8-401 Fresco
Nirwana Country
South City 2 | vijay.kher@medanta.org | 01244141414 | Medanta The Medicity | Inclusion criteria: 1 Laboratory confirmed diagnosis of COVID-19 infection with any of the following disease characteristics <br/ ><br>1A Early acute lung injury (ALI)/early acute respiratory distress syndrome (ARDS) <br/ ><br>1B Severe disease, defined as one of the following dyspnea, respiratory frequency more than or equal to 30/min <br/ ><br>blood oxygen saturation less than or equal to 93 percentage partial pressure of arterial oxygen to fraction of inspired oxygen ratio of more than 300 and or lung infiltrates more than 50 percentage within 24 to 48 hours <br/ ><br>1C Life-threatening disease, defined as one of the following respiratory failure septic shock and or multiple organ dysfunction or failure <br/ ><br>2 Admission to the ICU or area of the hospital repurposed to function as an ICU for surge capacity management <br/ ><br>3 Informed consent from the patient or legal representative <br/ ><br>4. Age more than 18 years <br/ ><br> | Exclusion criteria: 1 Stroke known or suspected within the last 3 months <br/ ><br>2 Severe congestive heart failure NYHA III and IV classes <br/ ><br>3 Acute an international normalized ratio INR of greater than 1 5 and any degree of mental alteration encephalopathy in a patient without preexisting cirrhosis and with an illness of less than 26 weeks duration or chronic Childs Pugh C liver disease <br/ ><br>4 Known preexisting non COVID 19 related hypercoagulability or another coagulopathy <br/ ><br>5 Inability to maintain a mean arterial pressure of more or 65 mm Hg despite vasopressors and fluid resuscitation <br/ ><br>6 Patients with known hypersensitivity to any component of the Hemopurifier <br/ ><br>7 Lack of commitment for full medical support <br/ ><br>8 Contraindications to extracorporeal blood purification therapy <br/ ><br>such as <br/ ><br>i Clinically relevant bleeding disorder <br/ ><br>ii Contraindication to anti-coagulation <br/ ><br>iii Pregnancy <br/ ><br>iv Inability to establish functional vascular access <br/ ><br>v Participation in another competing investigational drug device or vaccine trial <br/ ><br>vi Administration of an angiotensin converting enzyme ACE <br/ ><br>inhibitor in the previous 14 days <br/ ><br>vii Platelet count less than 50000 cells microliter <br/ ><br>9 Recent history of unstable or untreated intradialytic hypotension <br/ ><br>10 Subject is currently enrolled in an investigational drug or device <br/ ><br>trial Patient may be enrolled if they have received an investigational agent previously and it is more than 5 half lives since the last dose <br/ ><br>11 Any condition that in the opinion of the investigator would preclude the subject from being a suitable candidate for enrolment such as end stage chronic illness with no reasonable expectation of survival to hospital discharge | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Hemopurifier Device: Four hour treatment once daily for up to four days<br>Control Intervention1: Standard Care: According to Investigator discretions<br> | The goal of the study is to evaluate the use of the Hemopurifier device in <br/ ><br>the treatment of SARS CoV 2 Virus Disease COVID-19Timepoint: After each Hemopurifier treatment on day 1 to day 4 48 hours 96 hours 7 day 15 day and 28 day | | | | Yes | False | | |
| +++ | CTRI/2021/10/037605 | 8 November 2021 | Effect of adjuvant yoga therapy on cardiorespiratory morbidity in COVID | Effect of Adjuvant Yoga therapy on Long Term Cardiorespiratory Morbidity and Altered Serum Inflammatory Markers in COVID Recovered Patients - A Randomized Control Trial | | Aarupadi Veedu medical college | 27-10-2021 | 20211027 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61940 | Not Recruiting | No | | | | 09-11-2021 | 142 | Interventional | Randomized, Parallel Group Trial<br> Method of generating randomization sequence:Random Number Table Method of allocation concealment:An Open list of random numbers Blinding and masking:Participant Blinded | N/A | India | Dr Jothi Marie Feula A | | Assistant Professor
Department of Physiology
Aarupadai Veedu Medical College
Puducherry
Assistant Professor
Department of Physiology
Aarupadai Veedu Medical College
Puducherry
| dr.feula@gmail.com | | Aarupadai Veedu Medical College and Hospital, VMRF (Deemed to be university) | Inclusion criteria: COVID recovered patients of age group 18 â?? 45 years, after 3 months of initial infection, with negative RT PCR results will be recruited into the study. | Exclusion criteria: â?¢ Hypertension <br/ ><br>â?¢ Diabetes Mellitus <br/ ><br>â?¢ Other endocrine and metabolic disorders <br/ ><br>â?¢ On medications that affect autonomic nervous system <br/ ><br>â?¢ Pregnancy and lactation <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| Intervention1: Adjuvant Yoga therapy: 6 sessions will be given per weeks (3 observed and 3 non observed sessions / week) for 8 weeks duration.<br>Control Intervention1: Nil: Nil<br> | Effect of pranayma on cardiorespiratory morbidity and inflmmation in COVID recovered patientsTimepoint: Baseline, 4 weeks and 8 weeks | | | | Yes | False | | |
| +++ | CTRI/2021/10/037632 | 8 November 2021 | Use of neutrophil lymphocyte ratio in predicting early requirement of invasive ventilation in COVID 19 patients | Predicting early requirement of invasive ventilation in COVID 19 patients using neutrophil lymphocyte ratio. | | Jesica maria Dsouza | 27-10-2021 | 20211027 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62110 | Not Recruiting | No | | | | 15-11-2021 | 80 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | Bahamas | Jesica Maria Dsouza | | Department of anesthesia
Father muller medical college
Kankanady | priyamitali2000@yahoo.co.in | 9008420730 | Father muller medical college | Inclusion criteria: Adult patients age â?¥ 18 years. <br/ ><br>All the patients with a laboratory confirmation of COVID 19 infection(RTPCR) <br/ ><br> | Exclusion criteria: Cases with no laboratory confirmation of COVID 19 infection. <br/ ><br>Patients with history of carcinoma lung. <br/ ><br> | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | To determine the efficacy of NL ratio for predicting early requirement of invasive ventilation in COVID19 patients. <br/ ><br>To identify association of NL ratio with requirement of different types of oxygen therapy in COVID19 patients.Timepoint: 48 hours from admission | | | | Yes | False | | |
| +++ | CTRI/2021/10/037653 | 8 November 2021 | Recovery from anaesthesia in mucormycosis patients | Recovery from anaesthesia in post-COVID mucormycosis debridement surgery: An observational study | | Roopa Sachidananda | 28-10-2021 | 20211028 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=61135 | Not Recruiting | No | | | | 05-11-2021 | 72 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Roopa Sachidananda | | Plot no 12B first main road Muneshwarnagar, near vishwabharathi school, via unkal cross Hubli, Karnataka Dept of Anaesthesia
vidyanagar
KIMS | roopasac@gmail.com | 9448658220 | KIMS Hubli | Inclusion criteria: All patients who underwent post covid mucormycosis debridement surgery under general anesthesia | Exclusion criteria: debridement surgery for non-covid mucormycosis, or mucormycosis due to post transplant immunosuppression, uraemia, burns, malnutrition, malignancy and chemotherapy, pregnant and paediatric patients | Health Condition 1: B338- Other specified viral diseases
| Intervention1: NIL: NIL<br>Intervention2: NIL: NIL<br> | recovery from anaesthesia <br/ ><br>extubation timeTimepoint: upto 24 hours | | | | Yes | False | | |
| +++ | CTRI/2021/10/037664 | 8 November 2021 | Mask associated dry eye disease in spectacle users during COVID-19 pandemic | Mask associated dry eye disease during COVID-19 pandemic and its association with spectacle use | | H Aishwarya | 28-10-2021 | 20211028 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62037 | Not Recruiting | No | | | | 05-11-2021 | 72 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Investigator Blinded | N/A | India | H Aishwarya | | Department of ophthalmology, A.J institute of medical sciences and research center, Kutikana, NH 66, Mangalore | rajani_kadri@rediffmail.com | 918073083510 | A.J institute of medical sciences and research center, | Inclusion criteria: Group I- Spectacle wearer <br/ ><br>1. Participants who are willing to give informed consent. <br/ ><br>2. Participants who wear spectacles for more than 8 hours per day. <br/ ><br>3. Participants who wear mask (any type of mask) for more than 6 hrs per day (for at least 3 month) <br/ ><br> <br/ ><br>Group II- non spectacle wearer <br/ ><br>1. Participants who are willing to give informed consent. <br/ ><br>2. Participants who wear mask (any type of mask) for more than 6 hrs per day (for at least 3 month) | Exclusion criteria: 1. Patients not willing to give written informed consent. <br/ ><br>2. Contact lens users <br/ ><br>3. Participants who underwent refractive surgeries <br/ ><br>4. Participants with previous history of dry eye disease (or any other ocular surface disease) | | | Compare the risk of mask associated dry eyes in subjects with and without spectaclesTimepoint: Baseline | | | | Yes | False | | |
| +++ | CTRI/2021/10/037694 | 8 November 2021 | Musculoskeletal and rheumatological manifestations in COVID-19 | Musculoskeletal and rheumatological manifestations in COVID-19- A prospective, observational study | | Maulana Azad Medical College | 29-10-2021 | 20211029 | CTRI | http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=57897 | Not Recruiting | No | | | | 18-11-2021 | 50 | Observational | Other<br> Method of generating randomization sequence:Not Applicable Method of allocation concealment:Not Applicable Blinding and masking:Not Applicable | N/A | India | Deepak Ranjan Malla | | Room number 115, BL Taneja Block, 1st floor, Lok Nayak Hospital, Near Bahadur Shah Zafar Marg, Delhi | sumeetsingla555@gmail.com | | Maulana Azad Medical College, New Delhi | Inclusion criteria: Cofirmed COVID-19 cases (Positive for SARS-COV-2 by RT-PCR or rapid antigen test) | Exclusion criteria: 1. Patients with a pre-existing autoimmune rheumatic disease. <br/ ><br> <br/ ><br>2. Patients with a first degree relative (parents, children, siblings) who have autoimmune rheumatic disease. <br/ ><br> <br/ ><br>3. Patients above 65 years of age. <br/ ><br> <br/ ><br>4. Patients with HBV, HCV, HIV, tuberculosis (Active or past), leprosy, infective endocarditis, dengue, malaria, CLD/liver cirrhosis, malignancy and sarcoidosis. <br/ ><br> <br/ ><br>5. Patients taking drugs known to induce formation of ANA. <br/ ><br> <br/ ><br>6. Patient from another state. (Non- Delhite). | Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere
| | 1. Proportion of COVID-19 patients having musculoskeletal and rheumatologic manifestations at admission, at 4 weeks and 12 weeks after discharge. <br/ ><br>2. Proportion of COVID-19 patients having serum autoantibodies (RF, Anti CCP,ANA) at admission and 12 weeks after discharge.Timepoint: At the end of study | | | | Yes | False | | |
| → | PER-010-20 | 12 October 2021→8 November 2021 | SOLIDARITY: AN INTERNATIONAL RANDOMIZED CONTROLLED TRIAL TO EVALUATE NON-LICENSED COVID-19 TREATMENTS IN ADDITION TO STANDARD OF CARE AMONG HOSPITALIZED PATIENTS | SOLIDARITY: AN INTERNATIONAL RANDOMIZED CONTROLLED TRIAL TO EVALUATE NON-LICENSED COVID-19 TREATMENTS IN ADDITION TO STANDARD OF CARE AMONG HOSPITALIZED PATIENTS | | OMS/OPS, | 16/04/2020 | 20200416 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=010-20 | Recruiting | No | | | | 03/04/2020 | 1000 | Interventional | <br> The novel coronavirus that causes the disease COVID-19 is an international crisis that at the point of this request has caused more than 700,000 cases and 33,000 deaths worldwide. There are currently no vaccines or authorized treatments for COVID-19. Although treatments for other diseases may be of some help, they may not be. Therefore, the World Health Organization is organizing a study in many countries in which some of these treatments are compared to see if they are useful for the treatment of COVID-19. A randomized controlled trial with the following 5 treatments is proposed.<br> 1.Standard care that is given to all COVID patients who come to participating hospitals.<br> OR Standard care that is given to all COVID patients who come to participating hospitals plus one of the following:<br> 2.Remdesivir (daily infusion for 10 days)<br> 3. Hydroxychloroquine (two oral doses, then orally twice daily for 10 days)<br> 4.Lopinavir with Ritonavir (orally twice | III | Bahrain;Peru;Argentina;South Africa;Switzerland;Norway;Spain;Thailand;Iran;India | Patricia | Garcia | Av. Gral. Salaverry 801, Jesus Maria 15072 | patricia.garcia@upch.pe | 991886872 | MINISTERIO DE SALUD | Inclusion criteria: Adults ≥18 years, able to give informed consent, hospitalized or recently admitted as hospitalized patients diagnosed with COVID-19 and without advance transfer within 72 hours to a hospital that is not participating in the study. Patients invited to join the study will be those who report to hospitals / clinics, and there will be no other recruitment efforts | Exclusion criteria: Research subjects under the age of 18, undiagnosed with COVID-19, with a history of known allergy and contraindications to study treatments (eg, chronic liver disease, chronic heart disease, or are pregnant). |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:Standard of care Type of group;2 N° of participants:200 Intervention(s) description:Standard of care that all patients with COVID recieve at the hospital.<br> Group name:Standard of care plus lopinavir with ritonavir plus interferon beta 1a Type of group;1 N° of participants:200 Intervention(s) description:Standard care that is given to all COVID patients who come to this hospital / clinic plus Lopinavir with Ritonavir (orally twice a day for 14 days) plus interferon beta 1a (daily injection for 6 days). Lopinavir / Ritonavir is available from multiple manufacturers as fixed-dose thermostable tablets for oral administration: Lopinavir 200mg with Ritonavir 50mg per tablet. The oral solution for patients who cannot swallow is a light yellow to orange liquid containing 400 mg Lopinavir and 100 mg Ritonavir per 5 ml (80 mg Lopinavir and 20 mg Ritonavir per ml). Interferon beta 1a is supplied as a sterile solution that does not contain any preservative available in a pre-filled syringe. It is provided as a single dose pre-filled graduated syringe available in two strengths; either 44 micrograms per 0.5 ml or 22 micrograms per 0.5 ml (allowing a convenient supply of 44 ug doses for subcutaneous use). The liquid should be clear to slightly yellow. Do not use if the liquid is cloudy, discolored or contains particles. Use a different syringe. Contains the following inactive ingredients: Albumin (Human), Mannitol, Sodium Acetate, Water for Injection.<br> | <br> Outcome name:Ratio of the number of deaths among patients enrolled in the study<br> Measure:All-cause mortality<br> Timepoints:5 months<br> | | 26/01/2021 | | No | False | | |
| → | PER-011-20 | 12 October 2021→8 November 2021 | HYDROXYCHLOROQUINE TO PREVENT SARS-COV-2 INFECTION | HYDROXYCHLOROQUINE TO PREVENT SARS-COV-2 INFECTION AMONG HEALTHCARE WORKERS: RANDOMIZED CONTROLLED, OPEN-LABEL, PHASE 3 CLINICAL TRIAL | | UNIVERSIDAD PERUANA CAYETANO HEREDIA, | 14/05/2020 | 20200514 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=011-20 | Not Recruiting | No | | | | 11/05/2020 | 320 | Interventional | This is a randomized, open-label, phase 3 clinical trial by parallel groups evaluating the effectiveness of prophylaxis with hydroxychioroquina doses every -other -day plus standard measures of protection for the prevention of SARS-CoV-2 infection among healthcare workers in hospital services during the COVID-19 outbreak, compared to standard measures of protection. | III | Peru | Alvaro | Schwalb | Av. Honorio Delgado 430 | alvaro.schwalb@upch.pe | 988054875 | UNIVERSIDAD PERUANA CAYETANO HEREDIA | Inclusion criteria:
<br> A. Healthcare workers in service during the COVID-19 outbreak including medical, nurse, technical and auxiliary staff.
<br> B. Negative rapid serologic and molecular testing for SARS-CoV-2.
<br> C. Written informed consent.
<br> | Exclusion criteria:
<br> A. Presents COVID-19 symptoms including cough, fever, myalgias, headaches, loss of smell and taste
<br> B. Prior (last 30 days) or current (or planned use during the study period) use of hydroxychloroquine, chloroquine sulfate or azithromycin.
<br> C. Known history of prolonged QT syndrome.
<br> D. Known allergy or intolerance to hydroxychloroquine.
<br> E. Use of concomitant medications that are contraindicated with the use of hydroxychloroquine.
<br> F. Participation might not be beneficial, by investigator judgement.
<br> |
-B972 Coronavirus as the cause of diseases classified to other chapters
<br>Coronavirus as the cause of diseases classified to other chapters;B972;Coronavirus as the cause of diseases classified to other chapters | <br> Group name:Arm 1 Type of group;1 N° of participants:160 Intervention(s) description:Loading dose of 600mg of hydroxychloroquine orally, followed by 400mg of hydroxychloroquine every other day for 8 weeks and use of measures of personal protection.<br> Group name:Arm 2 Type of group;2 N° of participants:160 Intervention(s) description:Use of measures of personal protection.<br> | <br> Outcome name:Positive confirmatory or serologic testing for SARS-CoV-2<br> Measure:Efficacy<br> Timepoints:4 and 8 weeks<br> ;<br> Outcome name:Proportion of patients with grade 3 or more adverse events<br> Measure:Safety<br> Timepoints:4 and 8 weeks<br> | | | | No | False | | |
| → | PER-013-20 | 12 October 2021→8 November 2021 | CONVALESCENT PLASMA AS TREATMENT FOR COVID-19 | CONVALESCENT PLASMA USE AS TREATMENT FOR HOSPITALIZED PATIENTS WITH COVID-19 IN ESSALUD | | SEGURO SOCIAL DE SALUD, | 25/06/2020 | 20200625 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=013-20 | Not Recruiting | No | | | | 01/06/2020 | 192 | Interventional | Clinical trial controled with paralel groups, Phase II fo efecctiviness and safety to use plasma convalescent in hospitalized patient with COVID-19, compared with placebo (1:1) at Hospital Nacional Edgardo Rebagliati Martins | II | Peru | AUSBERTO | CHUNGA | Caminos del inca | Bettochunga17@hotmail.com | 990149288 | SEGURO SOCIAL DE SALUD- ESSALUD | Inclusion criteria:
<br> 1. Hospitalized patients ≥18 años
<br> 2. Informed consent
<br> 3. Confirmed diagnosis of SARS-CoV2 infection via RT-PCR of nasopharingeal swabing
<br> 4. Patients at risk of progression defined as having two or more of the following:
<br> • Ferritin > 500 ng/mL
<br> • D-dimer > 1 mg/L
<br> • Reactive C-Protein > 15 mg/L
<br> • Total Lymphocytes < 1000/mm3 or Neutrophil/Lymphocyte ratio > 3.13
<br> • Admission to a Intense care unit for management of COVID-19
<br>
<br> or pacients with severe diasease defined as having two or more of the following:
<br> • Dispnea
<br> • Respiratory rate >= 30 per minute
<br> • Oxygen Saturation < 93%
<br> • Po2/Fio2 < 300
<br> • Lung infiltrates > 50% in chest X-ray or Chest CT scan Iwith increasing compromise in a 24-48 hours period
<br>
<br> | Exclusion criteria:
<br> 1. Previous trasfusion of any hemoderivate in the 120 days prior to convalescent plasma administration
<br> 2. Active gestation
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:EXPERIMENTAL GROUP Type of group;1 N° of participants:60 Intervention(s) description:CONVALESCENT PLASMA<br> Group name:CONTROL GROUP Type of group;2 N° of participants:60 Intervention(s) description:STANDAR CARE<br> | <br> Outcome name:Clinical evaluation of patient requirements of O2 reservoir mask or high flux O2 or Non-Invasive ventilation with O2<br> Clinical evaluation of patient requirements of mechanical ventilation or extracorporeal oxygenation (ECMO)<br> Clinical evaluation or report of death status<br> Report of adverse events attributables to convalescent plasma<br><br> Measure:Oxygen Requirement<br> Ventilation Requirement<br> Death<br> Adverse Events<br><br> Timepoints:Day 14 and 28 after plasma administration<br> Day 14 and 28 after plasma administration<br> Day 14, 28 and 56 after plasma administration<br> During first 28 days after plasma administration<br> | | →31/05/2021 | | No | False | | |
| → | PER-016-20 | 12 October 2021→8 November 2021 | PERUCONPLASMA: EVALUATING THE USE OF CONVALESCENT PLASMA AS MANAGEMENT OF COVID-19 | PERUCONPLASMA: RANDOMIZED CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF THE USE OF CONVALESCENT PLASMA IN HOSPITALIZED PATIENTS WITH COVID-19 | | UNIVERSIDAD PERUANA CAYETANO HEREDIA, | 27/06/2020 | 20200627 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=016-20 | Not Recruiting | Yes | | | | 01/06/2020 | 98 | Interventional | <br> Open-label, randomized (1:1) phase 2b clinical trial to evaluate the safety<br> and efficacy of the use of convalescent plasma. This study will have two<br> arms, one arm will receive convalescent plasma plus standard of care, and<br> the other arm will receive the standard of care only. This study will consist<br> of two phases: Implementation phase: A centralized system will be<br> implemented to recruitment of plasma donors, and for collection,<br> processing and storage of convalescent plasma and plasma aliquots for<br> future studies. We expect to collect plasma from at least 30 recovered<br> COVID-19 patients before starting the next phase of the study. Use of<br> convalescent plasma phase: Patients from the experimental group will<br> receive 1 to 2 units of ABO compatible COVID-19 convalescent plasma<br> (200 ml to 250 ml each), obtained according to the established criteria, in<br> addition to the standard of care. Patients from | II | Peru | Patricia | Garcia | Av. Honorio Delgado 430 | patricia.garcia@upch.pe | 991886872 | UNIVERSIDAD PERUANA CAYETANO HEREDIA | Inclusion criteria:
<br> 􀀀 18 years old or older
<br> 􀀀 Hospitalized patient with COVID-19 disease, confirmed by a molecular test or a serologic test, along with a typical COVID-19 clinical presentation.
<br> 􀀀 Severe or critical disease caused by COVID-19
<br> Severe disease is defined as 2 or more of the following criteria:
<br> • Respiratory frequency >22
<br> • O2 saturation ≤93%
<br> • PaO2 <60mmHg, PaCO2 >50mmHg o
<br> • PaO2/FiO2 <300 Or
<br> Critical disease with one or more o the following criteria:
<br> • Respiratory insufficiency with requirement of mechanical ventilation within the last 72hours
<br> • Shock
<br> 􀀀 Inform consent signed by patient or direct family member
<br> | Exclusion criteria:
<br> 􀀀 Contraindication for transfusion (history of TRALI or TACO, history of anaphylaxis to blood components
<br> 􀀀 Multiorgan failure, defined by a SOFA score of >5
<br> 􀀀 Hemodinamically unstable, with PA<60 mmH, refractory to the use of vasopressors 􀀀 Uncontroled concomitant infection
<br> 􀀀 Disseminated intravascular coagulation
<br> 􀀀 Miocardial infarction
<br> 􀀀 Acute coronary disease
<br> 􀀀 Patient on dialysis
<br> 􀀀 Intracranieal bleeding active within last 7 days.
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:Experimental<br> group Type of group;1 N° of participants:49 Intervention(s) description:1 to 2 units of 200 ml to 250 ml of<br> COVID-19 convalescent from<br> recovered COVID-19 patients<br> Group name:Control<br> group Type of group;2 N° of participants:49 Intervention(s) description:Local standard of care<br> | <br> Outcome name:rate of development of serious adverse events<br> Measure:Serious adverse events related to transfusion of convalescent plasma<br> Timepoints:6 months<br> | | 17/04/2021 | | No | True | parent | |
| → | PER-018-20 | 12 October 2021→8 November 2021 |
A PHASE 2, OPEN LABEL, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF
ACALABRUTINIB WITH BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE IN
SUBJECTS HOSPITALIZED WITH COVID-19
|
A PHASE 2, OPEN LABEL, RANDOMIZED STUDY OF THE EFFICACY AND SAFETY OF
ACALABRUTINIB WITH BEST SUPPORTIVE CARE VERSUS BEST SUPPORTIVE CARE IN
SUBJECTS HOSPITALIZED WITH COVID-19
| | Acerta Pharma, BV, | 30/06/2020 | 20200630 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=018-20 | Recruiting | No | | | | 05/07/2020 | 30 | Interventional | <br> This is a multicenter, randomized, open-label, Phase 2 study that will evaluate acalabrutinib<br> plus BSC versus BSC in subjects with COVID-19 who are hospitalized.<br> Subjects will be randomly assigned (1:1) to receive one of the following 2 treatments:<br> Clinical Study Protocol - 3.0 AstraZeneca<br> Acalabrutinib - ACE-ID-201 (D822FC00001)<br> CONFIDENTIAL AND PROPRIETARY 16 of 88<br> • Arm 1: Acalabrutinib 100 mg twice daily (bid) x 10 days + BSC (n=70)<br> • Arm 2: BSC alone (n=70)<br> For the purpose of this study, BSC is per discretion of the Investigator and institutional<br> guidelines. However, refer to Section 5.2 and Section 6.5.3 for prohibited or restricted<br> concomitant therapy. Subjects will be randomized based on the following stratification<br> factors, which are considered prognostic factors for poor outcome:<br> • Age (≥ 65 vs < 65 years)<br> • Comorbidities (present vs absent). “Present” is defined as h | II | India;Japan;Turkey;Germany;Spain;Italy;Russian Federation;Sweden;South Africa;Argentina;Brazil;Chile;Mexico;Peru | Dra Ursula Rodriguez-Frias | Rodriguez-Frias | Av. El Derby Nº 055 Torre II oficina 503 | ursula.rodriguezfrias@astrazeneca.com | 6101540 | ASTRAZENECA PERU S.A. | Inclusion criteria:
<br> Subjects are eligible to be included in the study only if all of the criteria below apply.
<br> 1. Ability to understand the purpose and risks of the study and provide signed and dated
<br> informed consent or have a legal representative provide consent and authorization to use
<br> protected health information (in accordance with national and local patient privacy
<br> regulations).
<br> Clinical Study Protocol - 3.0 AstraZeneca
<br> Acalabrutinib - ACE-ID-201 (D822FC00001)
<br> CONFIDENTIAL AND PROPRIETARY 26 of 88
<br> 2. Men and women ≥18 years of age at the time of signing the Informed Consent Form
<br> (ICF).
<br> 3. SARS-CoV-2 confirmed per World Health Organization (WHO) criteria (including
<br> positive nucleic acid test of any specimen [eg, respiratory, blood, urine, stool, or other
<br> bodily fluid]) within 4 days of randomization.
<br> 4. COVID-19 pneumonia (documented radiographically) requiring hospitalization and
<br> oxygen saturation <94% on room air or requires supplemental oxygen.
<br> 5. Able to swallow pills.
<br> 6. Willing to follow contraception guidelines (refer to Appendix F).
<br> | Exclusion criteria:
<br> Subjects are excluded from the study if any of the criteria below apply.
<br> COVID-19 Related Medical Conditions
<br> 1. Respiratory failure at the time of screening (see Section 3 for definition of respiratory
<br> failure) due to COVID-19 pneumonia.
<br> 2. Known medical resuscitation within 14 days of randomization.
<br> 3. Any serious medical condition or abnormality of clinical laboratory tests that, in the
<br> Investigator´s judgment, precludes the subject’s safe participation in and completion of
<br> the study.
<br> 4. Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides
<br> infection with SARSCoV2).
<br> 5. In the opinion of the Investigator, progression to death is imminent and inevitable within
<br> the next 24 hours, irrespective of the provision of treatments.
<br> Medical Conditions
<br> 6. Not expected to survive 28 days given their preexisting, uncorrectable medical
<br> condition, for example, subjects with, or suspected to have, the following conditions:
<br> multiorgan failure, poorly controlled neoplasms; endstage cardiac disease; cardiac arrest
<br> requiring cardiopulmonary resuscitation or with pulseless electrical activity or asystole
<br> within past 30 days; endstage lung disease; endstage liver disease; or human
<br> immunodeficiency virus/acquired immunodeficiency syndrome with known endstage
<br> process.
<br> 7. Pregnant or breast feeding.
<br> 8. Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and/or bilirubin
<br> ≥ 3x upper limit of normal (ULN) and/or severe hepatic impairment (Child-Pugh
<br> class C; see Appendix G) detected within 24 hours at screening (per local laboratory).
<br> 9. Absolute neutrophil count (ANC) < 500/µL at screening (per local laboratory).
<br> 10. Platelet count < 50,000/µL at screening (per local laboratory).
<br> 11. Estimated creatinine clearance of <30 mL/min calculated using the Cockcroft-Gault
<br> formula [(140age) × mass (kg)/(72 × creatinine mg/dL) multiply by 0.85 if female].
<br> 12. Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the
<br> last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4).
<br> Exception: Subjects with controlled, asymptomatic atrial fibrillation during screening are
<br> allowed to enroll on study.
<br> 13. History of chronic hypercarbia, respiratory failure in past 6 months, or use of home
<br> oxygen in the setting of severe chronic respiratory disease.
<br> 14. Quadriplegia.
<br> 15. History of primary immunodeficiency, tuberculosis, progressive multifocal
<br> leukoencephalopathy (PML), aspergillus or other invasive mold/fungal infection, or
<br> received organ or bone marrow transplantation within 6 months of randomization.
<br> 16. Known active hepatitis B or C infection requiring therapy.
<br> Prior/Concomitant Therapy
<br> 17. Treatment with a strong cytochrome P450 (CYP)3A inhibitor (within 14 days before
<br> first dose of study drug) or inducer (within 7 days before first dose of study drug).
<br> 18. Requires treatment with proton-pump inhibitors (PPIs; eg, omeprazole, esomeprazole,
<br> lansoprazole, dexlansoprazole, rabeprazole, or pantoprazole). Subjects receiving PPIs
<br> who switch to H2-receptor antagonists or antacids are eligible for enrollment in this
<br> study.
<br> 19. Received oral anti rejection or immunomodulatory drugs (eg, anti-cytokines, Btk
<br> inhibitors, JAK inhibitors, PI3K inhibitors) within 30 days before ra |
-B972 Coronavirus as the cause of diseases classified to other chapters
<br>Coronavirus as the cause of diseases classified to other chapters;B972;Coronavirus as the cause of diseases classified to other chapters | <br> Group name:Arm 1 Type of group;1 N° of participants:70 Intervention(s) description:Patients will receive Acalabrutinib 100 mg VO twice daily (BID) per 10 days plus the best supportive care during the time at the discretion of the investigator and institutional guidelines.<br> Group name:Arm 2 Type of group;2 N° of participants:70 Intervention(s) description:Patients will receive only the best supportive care during the time at the discretion of the investigator and institutional guidelines.<br> | <br> Outcome name:Investigator assessment based on Respiratory insuffiency in hospitalized patients due to COVID-19 Infection<br> Measure:Proportion of subjects alive and free of respiratory failure at Day 14<br> Timepoints:From randomization to day 14.<br> | | 12/11/2020 | | Yes | False | | |
| → | PER-027-20 | 12 October 2021→8 November 2021 | A RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN HOSPITALIZED PATIENTS WITH COVID-19 PNEUMONIA | A RANDOMIZED, DOUBLE-BLIND, PLACEBO- CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF TOCILIZUMAB IN HOSPITALIZED PATIENTS WITH COVID-19 PNEUMONIA | | GENETECH, INC., | 24/06/2020 | 20200624 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=027-20 | Recruiting | No | | | | 21/06/2020 | 60 | Interventional | This is a Phase III, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy and safety of TCZ in combination with SOC compared with placebo in combination with SOC in hospitalized adult patients with COVID-19. The Sponsor intends to enroll approximately 379 patients that have been diagnosed with COVID-19 pneumonia and meet the entry criteria. | III | Kenya;South Africa;Brazil;Mexico;Peru;United States→United States;Peru;Mexico;Brazil;South Africa;Kenya | John | Cabanillas | Av. Republica de Panama 3461, Interior 1801 Urb. El palomar | john.cabanillas@ppdi.com | 6134182/998111515 | PPD Peru S.A.C. | Inclusion criteria:
<br> 1) Documented informed consent by any patient capable of giving consent, or, when the patient is not capable of giving consent, by his or her legal/authorized representative
<br> 2) Age 18 years
<br> 3) Ability to comply with the study protocol
<br> 4) Hospitalized
<br> 5) COVID-19 pneumonia confirmed per a positive PCR of any specimen (e.g., respiratory, blood, urine, stool, other bodily fluid) and radiographic imaging (CT scan or chest X-ray)
<br> 6) Able to complete screening within 96 hours of hospital admission.
<br> 7) Blood oxygen saturation (SpO2) 94% while on ambient air
<br> 8) For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception
<br> 9) For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agreement to refrain from donating sperm.
<br> | Exclusion criteria:
<br> 1) Known severe allergic reactions to TCZ or other monoclonal antibodies
<br> 2) Active tuberculosis (TB) infection
<br> 3) Suspected active bacterial, fungal, viral, or other infection (besides COVID-19)
<br> 4) In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatments
<br> 5) Have received oral anti-rejection or immunomodulatory drugs (including TCZ) with the past 3 months
<br> 6) Participating in other drug clinical trials (participation in COVID-19 anti-viral trials may be permitted if approved by Medical Monitor)
<br> 7) Pregnant or breastfeeding, or positive pregnancy test in a pre-dose examination
<br> 8) Treatment with an investigational drug within 5 half-lives or 30 days (whichever is longer) of randomization (investigational COVID-19 antivirals may be permitted if approved by Medial Monitor)
<br> 9) Any serious medical condition or abnormality of clinical laboratory tests that, in the investigator´s judgment, precludes the patient´s safe participation in and completion of the study
<br> 10) Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 10 x upper limit of normal (ULN) detected within 24 hours at screening (per local lab)
<br> 11) Absolute neutrophil count (ANC) < 1000/mL at screening (per local lab)
<br> 12) Platelet count < 50,000/mL at screening (per local lab)
<br> |
-J128 Other viral pneumonia
<br>Other viral pneumonia;J128;Other viral pneumonia | <br> Group name:Tocilizumab (TCZ) Type of group;1 N° of participants:30 Intervention(s) description:Participants will receive 1 intravenous (IV) infusion of TCZ, dosed at 8 mg/kg, up to a maximum dose 800 mg. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.<br> Group name:Tocilizumab Placebo Type of group;2 N° of participants:30 Intervention(s) description:Participants will receive 1 IV infusion of placebo matched to TCZ. Up to 1 additional dose may be given if clinical symptoms worsen or show no improvement.<br><br> | <br> Outcome name:The primary efficacy objective for this study is to evaluate the efficacy of TCZ plus SOC compared with placebo plus SOC. Time to death or the first utilization of mechanical ventilation after randomization will be compared between the TCZ group and the placebo group using the stratified log-rank test with age group (age 60, age 60 years) as the stratification factor. The cumulative proportion of patients with death or requiring mechanical ventilation at Day 28 will be estimated using the Kaplan-Meier method.<br><br> Measure:Cumulative proportion of patients with death or requiring mechanical ventilation by Day 28<br><br> Timepoints:Day 28<br> | | 16/09/2020 | | No | False | | |
| +++ | PER-030-20 | 8 November 2021 | PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RUXOLITINIB IN PATIENTS WITH COVID-19 ASSOCIATED CYTOKINE STORM (RUXCOVID) | PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF RUXOLITINIB IN PATIENTS WITH COVID-19 ASSOCIATED CYTOKINE STORM (RUXCOVID) | | Novartis Pharma AG., | 22/07/2020 | 20200722 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=030-20 | Not Recruiting | No | | | | 03/08/2020 | 60 | Interventional | This is a phase 3, randomized, double-blind, placebo-controlled, 29-day, multi-center study to assess the efficacy and safety of ruxolitinib + standard of care (SoC) therapy, compared with placebo + SoC therapy, in patients aged ≥12 years with COVID-19 pneumonia. Participants, investigator staff, persons performing the assessments, and clinical trial team will remain blind to the identity of the treatment from the time of randomization until database lock. | III | Germany;Spain;France;Italy;United Kindgdom;Russian Federation;Argentina;Brazil;Canada;Colombia;Mexico;Peru;United States | Cecilia | Ynouye | Jr. Juan de Arona 151, Oficinas 601-602 | cecilia.ynouye@novartis.com | 511 2006400 | NOVARTIS BIOSCIENCES PERU S.A. | Inclusion criteria:
<br> "1. Signed informed consent.
<br> 2. Male and female patients aged ≥ 12 years.
<br> 3. Patients with coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test or another rapid test.
<br> 4. Patient is currently (or will be) hospitalized.
<br> 5. Patients, who meet at least one of the below criteria:
<br> • Pulmonary infiltrates (chest X ray or chest CT scan);
<br> • Respiratory frequency ≥ 30/min;
<br> • Requiring supplemental oxygen;
<br> • Oxygen saturation ≤ 94% on room air;
<br> • Arterial oxygen partial pressure (PaO2)/ fraction of inspired oxygen (FiO2) < 300mmHg"
<br> | Exclusion criteria:
<br> "1. Hypersensitivity to any drugs/metabolites as ruxolitinib.
<br> 2. Presence of severely impaired renal function.
<br> 3. Suspected uncontrolled, active bacterial, fungal, viral, or other infection.
<br> 4. Current or history of active TB infection.
<br> 5. History of progressive multifocal leukoencephalopathy.
<br> 6. Intubated between screening and randomization.
<br> 7. In ICU at time of randomization.
<br> 8. Patients who are on anti-rejection, immunosuppressant or immunomodulatory drugs.
<br> 9. Intubated or in ICU for COVID-19 disease prior to screening.
<br> 10. Participating in any other investigational trials.
<br> 11. Unable to ingest tablets at randomization.
<br> 12. ALT ≥ 5 x ULN at screening.
<br> 13. Evidence of liver cirrhosis (Child A to C).
<br> 14. ANC < 1000/μL at screening.
<br> 15. Platelet count < 50,000/μL at screening.
<br> 16. Pregnant or nursing (lactating) women.
<br> 17. Females of childbearing potential unless the use of highly effective contraception method.
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:Ruxolitinib 5 mg + standard of care<br> Type of group;1 N° of participants:40 Intervention(s) description:One ruxolitinib 5 mg tablet will be administered orally twice per day approximately 12 hours apart in addition to the standar of care treatment for 14 days. Additional 14 days of study drug may be given in the opinion of the investigator. If a patient becomes intubated during the course of the study, study drug can be administered through a nasogastric tube.<br><br> Group name:Placebo + standard of care<br> Type of group;1 N° of participants:20 Intervention(s) description:One ruxolitinib matching placebo tablet will be administered orally twice per day approximately 12 hours apart in addition to the standar of care treatment for 14 days. Additional 14 days of study drug may be given in the opinion of the investigator.. If a patient becomes intubated during the course of the study, placebo treatment can be administered through a nasogastric tube.<br><br> | <br> Outcome name:"Proportion of subjects developing clinical failure by Day 29 with ruxolitinib + SoC versus placebo + SoC therapy.<br> The odds of clinical failure will be analyzed by a logistic regression model with treatment group, region, baseline clinical status based on the 9-point ordinal scale, age, and gender as covariates."<br><br> Measure:Clinical failure, defined as the occurrence of death, respiratory failure (require mechanical ventilation), or ICU care by Day 29<br><br> Timepoints:Day 29<br> | | 19/10/2020 | | Yes | False | | |
| → | PER-031-20 | 12 October 2021→8 November 2021 | PHASE 2 STUDY OF EFFICACY AND SAFETY OF PLASMA FROM CONVALESCENT PATIENTS WITH COVID-19 IN PATIENTS WITH MODERATE DISEASE (AUNA 20-01) | PHASE 2 STUDY OF EFFICACY AND SAFETY OF PLASMA FROM CONVALESCENT PATIENTS WITH COVID-19 IN PATIENTS WITH MODERATE DISEASE (AUNA 20-01) | | ONCOSALUD S.A.C., | 27/07/2020 | 20200727 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=031-20 | Not Recruiting | No | | | | 06/07/2020 | 50 | Interventional | This is a single arm phase 2 clinical trial to determine the efficacy and safety of convalescent plasma in COVID-19 patients with moderate disease. | II | Peru | Ina Noelia | Perez | AVENIDA GUARDIA CIVIL 571 SAN BORJA | iperez@auna.pe | 975369497 | ONCOSALUD S.A.C. | Inclusion criteria:
<br> - Patients of both sexes ≥ 18 years
<br> - Patient with a confirmed diagnosis of COVID-19 using moderately classified nasal and pharyngeal swab PCR tests, with some of the following symptoms:
<br> Dyspnea or respiratory distress
<br> Respiratory rate> 22 breaths / min
<br> Arterial oxygen saturation <95% in ambient air
<br> Alteration of the level of consciousness
<br> Low blood pressure or shock
<br> Clinical and / or radiological signs of pneumonia
<br> Lymphocyte count less than 1000 cel / uL
<br> - Acceptance of participation by signing an informed consent.
<br> - That it is not participating in another interventional study for COVID-19.
<br> | Exclusion criteria:
<br> - Patients with a history of previous transfusion allergic reaction.
<br> - Pregnant or lactating women (since there are no studies demonstrating their safety in pregnant and / or lactating women).
<br> - Patients who have received other types of immunoglobulin therapy in the previous 30 days.
<br> - Pediatric patient.
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:Experimental group Type of group;1 N° of participants:50 Intervention(s) description:They will be given an infusion of a 200 ml unit of convalescent COVID-19 plasma from ABO and compatible RH donors. The procedure will be repeated after 48 hours.<br><br> | <br> Outcome name:Disease progression towards severe COVID 19 (ICU admission) up to 14 days after the first plasma administration.<br> Progression to severe phase will be considered as any person with acute respiratory infection, with two or more of the following criteria:<br> - Respiratory rate> 22 breaths per minute or PaCO2 <32mmHg.<br> - Alteration of the level of consciousness<br> - Systolic blood pressure less than 100 mmHg or MAP <65 mmHg.<br> - PaO2 <60 mmHg or PaFi <300.<br> - Clinical signs of muscle fatigue: nasal flutter, use of accessory muscles, toro-abdominal imbalance.<br> - Serum lactate> 2 mosm / L.<br> Measure:Moderate phase progression to severe phase<br> Timepoints:Up to 14 days after the first plasma administration.<br> | | | | No | False | | |
| → | PER-032-20 | 12 October 2021→8 November 2021 | A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MAVRILIMUMAB (KPL-301) TREATMENT IN ADULT SUBJECTS HOSPITALIZED WITH SEVERE COVID-19 PNEUMONIA AND HYPER-INFLAMMATION | A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MAVRILIMUMAB (KPL-301) TREATMENT IN ADULT SUBJECTS HOSPITALIZED WITH SEVERE COVID-19 PNEUMONIA AND HYPER-INFLAMMATION | | Kiniksa Pharmaceuticals, Ltd., | 23/07/2020 | 20200723 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=032-20 | Recruiting | No | | | | 22/07/2020 | 115 | Interventional | <br> This is a prospective, Phase 2/3, interventional, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy and safety of mavrilimumab (KPL-301) treatment in adult subjects hospitalized with severe COVID-19 pneumonia and hyper-inflammation. Approximately 573 subjects, divided into 2 cohorts, will be enrolled and randomized in a 1:1:1 allocation ratio to receive a single IV infusion of mavrilimumab (10 mg/kg or 6 mg/kg) or placebo. Cohort 1 will include non-intubated hospitalized subjects who require supplemental oxygen to maintain SpO2 ≥ 92%, ie, “non-ventilated” subjects. Cohort 2 will include hospitalized subjects for whom mechanical ventilation was recently initiated (within 48 hours prior to randomization), ie, “ventilated” subjects). The initial Phase 2 part of the study will enroll approximately 156 subjects, and the Phase 3 part will enroll approximately 417 subjects. There will be a seamless transition in enrollment of subjects in b | II | Ireland;Italy;United Kindgdom;South Africa;Chile;Peru;United States | Rosmery | Osorio | Calle Amador Merino Reyna N° 307, Of. 1401 | rosmery.osorioubaldo@parexel.com | 4231923 | PAREXEL INTERNATIONAL (PERU) S.A. | Inclusion criteria:
<br> Subjects must meet all the following inclusion criteria to be eligible for enrollment in the study.
<br> 1. Subject (or legally authorized representative) is able and willing to provide informed consent, which includes compliance with study requirements and restrictions listed in the consent form. Consent must be performed per institutional regulations.
<br> 2. Age of ≥ 18 years
<br> 3. Positive SARS-CoV-2 (2019-nCoV) test within 14 days prior to randomization
<br> 4. Hospitalized for SARS-CoV-2 (2019-nCoV)
<br> 5. Bilateral pneumonia on chest x-ray or computed tomography (CT)
<br> 6. Active fever or recently documented fever within 72 hours prior to randomization (≥100.4°F or ≥38°C)
<br> 7. At least one of the following:
<br> • Ferritin > 500 ng/mL
<br> • CRP > 5 mg/dL
<br> • D-dimer > 1,000 ng/mL
<br> • LDH > 250 U/L
<br> 8. Cohort 1: Receiving any form of non-invasive ventilation OR oxygenation to maintain SpO2 ≥ 92% and not-intubated [examples include nasal cannula, face mask, venturi mask, high-flow nasal cannula, and non-invasive ventilation (NIV) or non-invasive positive pressure ventilation (NIPPV)]
<br> 9. Cohort 2: Recently ventilated with mechanical ventilation beginning within 48 hours prior to randomization
<br> | Exclusion criteria:
<br> Subjects who meet any of the following exclusion criteria will not be eligible for study enrollment.
<br> General Exclusion Criteria
<br> 1. Onset of COVID-19 symptoms > 14 days from randomization
<br> 2. Hospitalized > 7 days prior to randomization
<br> 3. [For Cohort 1 only] Need for invasive mechanical ventilation
<br> 4. Need for ECMO
<br> 5. Serious prior or concomitant illness that in the opinion of the Investigator precludes the subject from enrolling in the trial, including (but not limited to):
<br> • History of pulmonary alveolar proteinosis (PAP)
<br> • History of immunodeficiency (congenital or acquired)
<br> • History of solid-organ or bone marrow transplant
<br> • Current systemic autoimmune or autoinflammatory disease(s) requiring systemic immune-modulating drugs
<br> • History of or active cancer within the last 10 years - except for basal and squamous cell carcinoma of the skin or in situ carcinoma of the cervix treated and considered cured
<br> • Severe and uncontrolled pulmonary disease other than COVID-19 pneumonia (eg, asthma, chronic obstructive pulmonary disease [COPD], or others)
<br> • Pre-existing severe left ventricular systolic dysfunction (ie, left ventricular ejection fraction [LVEF] < 35%)
<br> • Known active tuberculosis (TB) determined by history and local standard of care, or history of incompletely treated TB or at high risk for latent TB (exposure or prior incarceration)
<br> • Concomitant uncontrolled systemic bacterial or fungal infection
<br> • Concomitant respiratory viral infection other than COVID-19 that, in the opinion of the Investigator, represents a higher mortality risk (eg, SARS, MERS)
<br> • History of chronic liver disease with portal hypertension
<br> 6. Recent treatment with cell-depleting biological therapies (eg, anti-CD20) within 12 months, cell-depleting biological therapies (such as anti-TNF, anakinra, anti-IL-6 receptor [eg, tocilizumab], or abatacept) within 8 weeks (or 5 half-lives, whichever is longer), treatment with alkylating agents within 12 weeks, treatment with cyclosporine A, azathioprine, cyclophosphamide, mycophenolate mofetil (MMF), COVID-19-immune plasma, or other immunosuppressant within 4 weeks prior to randomization
<br> 7. Recent treatment with intramuscular live (attenuated) vaccine within 4 weeks prior to randomization
<br> 8. Corrected QT interval by Federicia method (QTcF) on Screening ECG ≥450ms
<br> 9. Chronic or recent (within 1 month) corticosteroid use > 10 mg/day
<br> 10. Enrolled in another investigational study of a medical intervention within 30 days prior to randomization
<br> 11. Known hypersensitivity to mavrilimumab or any of its excipients
<br> 12. In the opinion of the Investigator, unable to comply with the requirements to participate
<br> in the study
<br> 13. Female subjects must be:
<br> • postmenopausal, defined as at least 12 months post cessation of menses (without an alternative medical cause), or
<br> • permanently sterile following documented hysterectomy, bilateral salpingectomy, bilateral oophorectomy, or tubal ligation or having a male partner with vasectomy as affirmed by the subject, or
<br> • nonpregnant, nonlactating, and if sexually active having agreed to use a highly effective method of contraception (ie, hormonal contraceptives associated with inhibition of ovulation or intrauterine device [IUD], or intrauterine hormone-releasing system [IUS], or sexual abstinence) from Screening Visit until Day 90.
<br> 14. M |
-J22 Unspecified acute lower respiratory infection
<br>Unspecified acute lower respiratory infection;J22 ;Unspecified acute lower respiratory infection | <br> Group name:placebo-controlled study to evaluate the efficacy and safety of mavrilimumab (KPL-301) treatment in adult subjects hospitalized with severe COVID-19 pneumonia and hyper-inflammation Type of group;1 N° of participants:573 Intervention(s) description:Mavrilimumab (KPL-301, formerly known as CAM-3001) is a recombinant human monoclonal immunoglobulin G (IgG)4 antibody, which modulates activity of granulocyte-macrophage colony-stimulating factor (GM-CSF) by binding to the alpha subunit of its receptor (GMCSFRα).<br> Mavrilimumab is a sterile, clear to opalescent, colorless to slightly brown-yellow liquid, free from visible particles and is formulated at 150 mg/mL in 50 mM sodium acetate, 70 mM sodium chloride, 4% weight/volume trehalose dihydrate, 0.05% weight/volume polysorbate 80 with a pH of 5.8. It is supplied by Kiniksa Pharmaceuticals as a liquid in accessorized pre-filled syringes or in vials for parenteral administration. Please see the Pharmacy Manual for additional details Subjects will receive a single IV infusion of either 10 mg/kg or 6 mg/kg mavrilimumab or placebo over approximately 60 minutes. Total dose may not exceed 1000 mg, which was approximately the maximum dose administered in the Phase 1 study with IV infusion. Dosing will be based on body weight obtained at Screening. Additional details regarding mavrilimumab<br><br><br> | <br> Outcome name:1. Death;<br> 2. Hospitalized, on invasive mechanical ventilation or ECMO;<br> 3. Hospitalized, on non-invasive ventilation or high flow oxygen devices;<br> 4. Hospitalized, requiring supplemental oxygen;<br> 5. Hospitalized, not requiring supplemental oxygen - requiring ongoing medical care (COVID 19 related or otherwise);<br> 6. Hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care;<br> 7. Not hospitalized, limitation on activities and/or requiring home oxygen;<br> 8. Not hospitalized, no limitations on activities.<br> Measure:Cohort 1 (non-ventilated subjects)<br> Proportion of subjects alive and without respiratory failure at Day 15, where respiratory failure is defined as the need for high flow oxygen (HFO), non-invasive ventilation (NIV), invasive mechanical ventilation (IMV), or extracorporeal membrane oxygenation (ECMO).<br> Respiratory failure status will be evaluated based on the National Institute of Allergy and Infectious Diseases (NIAID) clinical outcome 8-point ordinal scale. Subjects whose clinical outcome meets NIAID categories 2 or 3 will be considered as having respiratory failure.<br> Timepoints:Cohort 2 (ventilated subjects)<br> The primary efficacy endpoint is mortality rate, defined as the proportion of subjects who die by Day 15.<br> | | | | No | False | | |
| → | PER-034-20 | 12 October 2021→8 November 2021 | RANDOMIZED PHASE IIA CLINICAL TRIAL TO COMPARE THE EFFICACY OF IVERMECTIN VERSUS PLACEBO TO OBTAIN NEGATIVE PCR RESULTS IN PATIENTS WITH EARLY PHASE COVID-19 | RANDOMIZED PHASE IIA CLINICAL TRIAL TO COMPARE THE EFFICACY OF IVERMECTIN VERSUS PLACEBO TO OBTAIN NEGATIVE PCR RESULTS IN PATIENTS WITH EARLY PHASE COVID-19 | | UNIVERSIDAD PERUANA CAYETANO HEREDIA, | 17/07/2020 | 20200717 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=034-20 | Recruiting | No | | | | 09/07/2020 | 68 | Interventional | This al is a triple-blind, randomized phase 2a ontrolled trial with two parallel groups to evaluate the efficacy of ivermectin in reducing nasal viral carriage at 7 days after treatment in SARS-CoV-2 infected patients. The study will recruit 68 patients (34 per group). Selected patients will be randomized to receive one (1) daily dose of 300 mcg/kg ivermectin or an equivalent placebo during three (3) consecutive days, and they will remain in the trial for a period of 21 days.. This study will take place in the Hospital Cayetano Heredia. | II | Peru | Patricia Jannet | Garcia | Av. Honorio Delgado 430 | patricia.garcia@upch.pe | 991886872 | UNIVERSIDAD PERUANA CAYETANO HEREDIA | Inclusion criteria: 1. Patients with COVID-19 typical symptoms (cough, fever, anosmia) present for not more than 96 hours, 2. The patient must be elder than 18 years old. 3. Not previous administration of ivermectin before the study. 4. No known history of ivermectin allergy. 5. The patient can give his consent to take part in the study. 6. Current use of CYP 3A4 or P-gp inhibitor drugs such as quinidine, amiodarone, diltiazem, spironolactone, verapamil, clarithromycin, erythromycin, itraconazole, ketoconazole, cyclosporine, tacrolimus, indinavir, ritonavir or cobicistat. Use of critical CYP3A4 substrate drugs such as warfarin. | Exclusion criteria:
<br> 1. COVID-19 pneumonia
<br> • Diagnosed by the attending physician (oxygen saturation < 95% or lung crackles)
<br> 2. Positive pregnancy test for women of child bearing age
<br> 3. Positive IgG against SARS-CoV-2 by rapid diagnostic test.
<br> 4. Negative SARS-CoV-2 PCR from a nasopharyngeal swab.
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:IVERMECTIN Type of group;1 N° of participants:34 Intervention(s) description:The participants will receive one (1) daily dose of 300 mcg/kg ivermectina for three (3) consecutive days. The Ivermectin presentation will be an oral drop solution.<br> Group name:Ivermectin placebo Type of group;2 N° of participants:34 Intervention(s) description:The participants will receive one (1) daily dose of an ivermectin placebo for three (3) consecutive days. The placebo presentation will be an oral drop solution undistinguishable<br> | <br> Outcome name:Use of PCR for SARS-CoV-2. The primary outcome measure will be assessed using Fisher´s exact test.<br> Measure:Proportion of patients with a positive SARS-CoV-2 PCR from a nasopharyngeal swab at day 7 post-treatment<br> Timepoints:At day 7 post-treatment.<br> | | 28/04/2021 | | No | False | | |
| → | PER-042-20 | 12 October 2021→8 November 2021 | Investigating otilimab in patients with severe pulmonary COVID-19 related disease | A randomized, double-blind, placebo-controlled, study evaluating the efficacy and safety of otilimab IV in patients with severe pulmonary COVID-19 related disease | | GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LIMITED, | 21/08/2020 | 20200821 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=042-20 | Not Recruiting | No | | | | 01/08/2020 | 35 | Interventional | This study is a multi-center, randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of otilimab for the treatment of severe pulmonary COVID-19 related disease. The study population consists of hospitalized participants with new onset hypoxia requiring significant oxygen support or requiring invasive mechanical ventilation (≤48 hours before dosing). All participants will receive standard of care as per institutional protocols, in addition to study treatment. | II | United States;Peru;Mexico;Colombia;Chile;Canada;Brazil;Argentina;South Africa;Nederland;Sweden;United Kindgdom;Poland;France;Spain;Belgium;Japan;India | Jose Carlos | Sandoval | Javier Prado Oeste 995, San Isidro | jose.c.sandoval@gsk.com | 995954846 | GLAXOSMITHKLINE PERU S.A. | Inclusion criteria:
<br> 1) Age ≥18 years and ≤79 years
<br> 2) Have positive SARS-CoV-2 result
<br> 3) Be hospitalized due to diagnosis of pneumonia (chest X-ray or computerized tomography [CT] scan)
<br> 4) Be developing new onset of oxygenation impairment requiring any of the following: high-flow oxygen (≥15L/min); non-invasive ventilation (e.g. CPAP, iPAP); mechanical ventilation ≤48h prior to dose
<br> 5) Have increased biological markers of systemic inflammation.
<br> 6) No gender restriction
<br> 7) Female participants must meet and agree to abide by the contraceptive criteria.
<br> 8) Capable of giving written informed consent. If participants are not capable of giving written informed consent, alternative consent procedures.
<br>
<br> For more details check the protocol
<br> | Exclusion criteria:
<br> 1) Progression to death is imminent and inevitable within the next 48 hours, irrespective of the provision of treatments, in the opinion of the investigator.
<br> 2) Multiple organ failure according to the investigator’s judgement or a Sequential Organ Failure assessment (SOFA score) >10 if in the ICU
<br> 3) Extracorporeal membrane oxygenation (ECMO) hemofiltration/dialysis, or high dose (>0.15ug/kg/min) noradrenaline (or equivalent) or more than one vasopressor
<br> 4) Current serious or uncontrolled medical condition or abnormality of clinical
<br> 5) Untreated systemic bacterial, fungal, viral, or other infection
<br> 6) Known active tuberculosis (TB), history of untreated or incompletely treated active or latent TB, suspected or known extrapulmonary TB
<br> 7) Known HIV regardless of immunological status
<br> 8) Known HBsAg and/or anti-HCV positive
<br> 9) Currently receiving radiotherapy, chemotherapy or immunotherapy for malignancy
<br> 10) Received immunosuppressant therapy including but not limited to cyclosporin, azathioprine, tacrolimus, mycophenolate, JAK inhibitors within the last 3 months prior to randomization
<br> 11) Received monoclonal antibody therapy (e.g. tocilizumab, sarilumab) within the past 3 months prior to randomization
<br> 12) History of allergic reaction, including anaphylaxis to any previous treatment with an anti-GM-CSF therapy
<br> For more details check the protocol
<br> |
-J128 Other viral pneumonia
<br>Other viral pneumonia;J128;Other viral pneumonia | <br> Group name:Otilimab Type of group;1 N° of participants:400 Intervention(s) description:Participants receive a blinded 1-hour infusion of Otilimab 90 mg IV in addition to standard of care.<br> Group name:Otilimab placebo Type of group;2 N° of participants:400 Intervention(s) description:Participants receive a blinded 1-hour infusion of Otilimab placebo 90 mg IV in addition to standard of care.<br> | <br> Outcome name:To compare the efficacy of otilimab 90 mg IV versus placebo<br> Measure:To compare the efficacy of otilimab 90 mg IV versus placebo<br> Timepoints:28 days<br> | | 19/10/2020→10/01/2021 | | No | False | | |
| → | PER-050-20 | 12 October 2021→8 November 2021 | “A PHASE 1/2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF TL-895 WITH STANDARD AVAILABLE TREATMENT VERSUS STANDARD AVAILABLE TREATMENT FOR THE TREATMENT OF COVID-19 IN PATIENTS WITH CANCER” | “A PHASE 1/2, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF TL-895 WITH STANDARD AVAILABLE TREATMENT VERSUS STANDARD AVAILABLE TREATMENT FOR THE TREATMENT OF COVID-19 IN PATIENTS WITH CANCER” | | Telios Pharma, Inc, | 17/09/2020 | 20200917 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=050-20 | Not Recruiting | No | | | | 28/09/2020 | 30 | Interventional | <br> This global, multicenter, Phase 1/2, randomized, double-blind, placebocontrolled study will evaluate the efficacy and safety of adding TL-895 treatment to standard available therapy (SAT) in subjects with cancer hospitalized for COVID-19.<br> This is a 2-part study comprising a Phase 1 safety lead-in (Part 1) that will determine the RP2D to be used in all subsequent eligible subjects in Phase 2 (Part 2).<br> Part 1 (Phase 1 safety lead-in) comprises a 6 subject run-in to evaluate the safety and tolerability of TL-895 in patients with cancer in the COVID-19 setting. TL-895 will be administered orally at the assigned dose continuously in 7-day cycles for 2 cycles and subjects will be evaluated for dose limiting toxicities (DLTs). The starting dose of 200 mg BID is based on the optimal biological dose from the first-in-human clinical study, with adjustment for the increase in exposure observed with TL-895 tablets. If at the 200 mg BID dose level ≤1 of 6 subjects e | II | United States;Peru;Brazil;Argentina;Ukraine;Russian Federation;Romania;Italy;Hungary;France;Spain;Denmark;Germany;Philippines | Rosmery | Osorio | Calle Amador Merino Reyna N° 307, Of. 1401 | rosmeryosorio@hotmail.com | 423-1923 | PAREXEL INTERNATIONAL (PERU) S.A. | Inclusion criteria:
<br> 1. Adults ≥18 years of age.
<br> 2. Known diagnosis of active cancer that is not considered cured or disease free.
<br> 3. Confirmed COVID-19 infection as per World Health Organization (WHO) criteria (including positive nucleic acid test of any specimen [e.g., respiratory, blood, urine, stool, or other bodily fluid] within 3 weeks of Cycle 1 Day 1) with suspected pneumonia requiring hospitalization and oxygen saturation <94% on room air or requires supplemental oxygen
<br> 4. Adequate hematological function independent of growth factor support for at least 7 days except for pegylated G-CSF and darbepoetin which require at least 14 days, defined as:
<br> a. Absolute neutrophil count (ANC) ≥ 1.0 × 109 /L for subjects with solid malignancies. ANC ≥ 0.75 × 109 /L for subjects with hematologic malignancies
<br> b. Platelet count ≥ 75 × 109 /L for subjects with solid malignancies. Platelet count ≥ 50 × 109 /L for subjects with hematologic malignancies.
<br> 5. Adequate hepatic function defined by:
<br> a. Total bilirubin within normal limits, if total bilirubin is >upper limit of normal (ULN), then subjects are eligible if the direct bilirubin ≤2.0 × ULN
<br> b. Aspartate aminotransferase (AST) ≤ 2.5 × ULN, and alanine aminotransferase (ALT) ≤ 2.5 × ULN.
<br> 6. Adequate renal function defined by an estimated creatinine clearance ≥ 30 mL/min according Cockcroft Gault method.
<br> 7. Ability to swallow and absorb oral medications
<br> 8. Female subjects of childbearing potential and their male partners, or male subjects who have female partners of childbearing potential, must both use an effective contraception method during the study and continue to use contraception for 60 days after the last dose of study drug. Effective birth control for males is the use of condoms. Effective birth control for females includes
<br> (a) combined, estrogen- and progestogen-containing hormonal contraception (oral, intravaginal, transdermal); (b) intrauterine device combined with a barrier method; (c) intrauterine hormone-releasing system combined with a barrier method; (d) bilateral tubal occlusion/ligation; (e) vasectomized partner;
<br> (f) sexual abstinence when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
<br> | Exclusion criteria:
<br> 1. Sujetos con una esperanza de vida inferior a 6 meses.
<br> 2. No hay mas terapias disponibles para las neoplasias malignas avanzadas o metastasicas.
<br> 3. Sujetos con una instruccion de atencion medica avanzada que incluye ordenes de DNI (do not intubate [no intubacion]) o DNR (do not resuscitate [no resucitacion]).
<br> 4. Tratamiento activo con inhibidores de BTK, BMX, PI3k, IL1β o JAK
<br> 5. Sujetos que requieran quimioterapia debido a una enfermedad oncologica activa que no se pueda suspender mientras reciben el tratamiento del estudio.
<br> 6. Sujetos con apariciones nuevas de neoplasias malignas que requieran terapia sistemica con urgencia debido a la enfermedad oncologica activa.
<br> 7. Sujetos que recibieron quimioterapia sistemica, lo que resulta en la inmunosupresion en un plazo de 14 dias previos al dia 1 del ciclo 1.
<br> 8. Tratamiento activo con medicamentos inmunomoduladores, incluidos los inhibidores de puntos de control inmunitario (bloqueadores de PD-1, PD-L1, CTLA4) que no podria suspenderse mientras dure el estudio.
<br> 9. Sujetos que recibieron previamente terapia con anticitocinas (anti-IL-6) dentro de 5 semividas del farmaco desde el dia 1 del ciclo 1.
<br> 10. Participacion en otro estudio clinico con intencion terapeutica para la COVID-19. La unica excepcion es que se permitiran los pacientes que participan en ensayos clinicos que reciben hidroxicloroquina o cloroquina, y/o azitromicina y/o remdesivir.
<br> 11. Pacientes que recibian warfarina al ingresar en el estudio.
<br> 12. Pacientes que reciben terapia combinada antiplaquetaria y de anticoagulacion terapeutica (HBPM o DOAC).
<br> 13. Infarto de miocardio en un plazo de 6 meses, angina inestable, arritmia cardiaca no controlada, o insuficiencia cardiaca de clase 3/4 conforme a la Asociacion Cardiologica de Nueva York (NYHA).
<br> 14. Necesidad de respiracion artificial (HFNC, NiPPV, ECMO, o intubacion y RM) en la seleccion.
<br> 15. Trastornos conocidos de sangrado (p. ej., enfermedad de Von Willebrand, trastornos de almacenamiento del pool plaquetario o hemofilia).
<br> 16. Accidente cerebrovascular o hemorragia intracraneal dentro de los 6 meses previos al dia 1 del ciclo 1.
<br> 17. Mujeres embarazadas o en periodo de lactancia.
<br> 18. Necesidad de tratamiento con inhibidores de la bomba de protones (p. ej., omeprazol, esomeprazol, lansoprazol, dexlansoprazol, rabeprazol o pantoprazol). Los sujetos que reciben inhibidores de la bomba de protones y que cambian a antagonistas del receptor H2 o antiacidos son elegibles para inscribirse en este estudio.
<br> 19. Sujetos con virus activo de hepatitis B (VHB) o hepatitis C (VHC).
<br> 20. Sujetos con antecedentes conocidos del virus de inmunodeficiencia humana (VIH).
<br> 21. Prolongacion del QTc de grado 2 o superior (>480 milisegundos conforme a la terminologia comun para
<br> eventos adversos del Instituto Nacional del Cancer [v 5.0]).
<br> 22. Enfermedad que afecte significativamente la funcion gastrointestinal y/o que inhiba la absorcion del intestino delgado (sindrome de malabsorcion, reseccion del intestino delgado, enfermedad intestinal inflamatoria mal controlada, etc.).
<br> 23. Pacientes que reciban radioterapia para el pulmon o mediastino para el tratamiento de la COVID-19.
<br> 24. Lesiones del sistema nervioso central (SNC) no tratadas o conocidas con progresion activa (meningitis carcinomatosa).
<br> Los pacientes con antecedentes de lesiones del SNC son elegibles, siempre y |
-J22 Unspecified acute lower respiratory infection
<br>Unspecified acute lower respiratory infection;J22 ;Unspecified acute lower respiratory infection | <br> Group name:Double-Blind, Randomized, Placebo-Controlled Study of TL-895 with Standard Available Treatment versus Standard Available Treatment for the Treatment of COVID-19 in Patients with Cancer Type of group;1 N° of participants:146 sujetos Intervention(s) description:The investigational product in this study will be TL-895 (formerly M7583). TL-895 will be used in both Part 1 and Part 2 of the study. The dose in Part 1 will start at the 200 mg BID dose followed by 150 mg and 100 mg BID, as needed, depending on DLT at each dose level. The Phase 2 dose will be the RP2D from Part 1. TL-895 is supplied as film-coated tablets and available at strengths of 50 mg (with excipients).<br><br> | <br> Outcome name:The proportion of subjects per arm requiring artificial ventilation (intubation and mechanical ventilation [MV], extracorporeal membrane oxygenation [ECMO], heated, humidified high-flow nasal cannula oxygen [HFNC], noninvasive positive pressure ventilation [NiPPV]) or death from Day 1 through Day 29 of study treatment.<br> Measure:DLTs will be used to establish the RP2D.<br> Timepoints:Part 1 and Part 2<br> | | | | Yes | False | | |
| → | PER-051-20 | 12 October 2021→8 November 2021 |
INACTIVATED SARS-COV-2 VACCINE (VERO CELL)
PHASE III CLINICAL STUDY PROTOCOL
| RANDOMIZED, DOUBLE BLIND, PARALLEL PLACEBO CONTROLLED, PHASE III CLINICAL TRIAL TO EVALUATE THE SAFETY AND PROTECTIVE EFFICACY OF INACTIVATED SARS-COV-2 VACCINE IN HEALTHY POPULATION AGED 18 YEARS AND ABOVE | | UNIVERSIDAD PERUANA CAYETANO HEREDIA, | 18/08/2020 | 20200818 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=051-20 | Not Recruiting | No | | | | 15/09/2020 | 12000 | Interventional | <br> This clinical trial is conducted in randomized, blind, placebo-controlled design.<br><br> Total sample size is 6,000, which are randomly allocated into investigational vaccine 1, investigational vaccine 2 and placebo control group.<br> | III | Peru | German Javier | Malaga | Av. Honorio Delgado 430 | german.malaga@upch.pe | 992768300 | UNIVERSIDAD PERUANA CAYETANO HEREDIA | Inclusion criteria:
<br> - Age range: Healthy subjects aged 18 years old and above
<br> - By asking for medical history and physical examination, the investigator judged that the health condition is well.
<br> - Female subjects of childbearing age are not nursing or pregnant at the time of enrolment (negative urine pregnancy test), and do not plan to become pregnant within the first 3 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion and continued for at least three months after last dose.
<br> - During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan.
<br> - With self-ability to understand the research procedures, with informed consent, voluntarily sign an informed consent form, and be able to comply with the requirements of the clinical study protocol.
<br> | Exclusion criteria:
<br> First dose exclusion criteria
<br> - SARS-CoV-2 Infection Confirmed Cases, Suspected Cases or Asymptomatic Infection
<br> - SARS-CoV-2 Nucleic acid test positive
<br> - Have a history of SARS, MERS infection (self-report, on-site inquiry)
<br> - Fever (axillary temperature > 37.0 ℃), dry cough, fatigue, nasal obstruction, runny nose, pharyngeal pain, myalgia, diarrhea, shortness of breath and dyspnea occurred within 14 days before vaccination.
<br> - Axillary body temperature > 37.0 ℃ before vaccination
<br> - Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known ingredients of inactivated SARS-CoV-2 vaccine have occurred.
<br> - Have a history of convulsion, epilepsy, encephalopathy or mental illness or family history.
<br> - Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.
<br> - Severe liver and kidney diseases, uncontrollable hypertension (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute attack period of chronic diseases.
<br> - Has been diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases.
<br> - Diseases known or suspected include severe respiratory diseases, severe cardiovascular diseases, liver and kidney diseases, and malignant tumors.
<br> - History of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease)
<br> - Receiving anti-TB therapy.
<br> - Patients receiving immunotherapy or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days)
<br> - Live attenuated vaccine is inoculated within 1 month before this vaccination, other vaccines are inoculated within 14 days before this vaccination.
<br> - Received blood products within 3 months before this vaccination
<br> - Received other research drugs within 6 months before this vaccination.
<br> - Investigator judged other circumstances that are not suitable for this clinical trial.
<br>
<br>
<br> Second dose exclusion criteria
<br> - Patients with high fever (axillary temperature ≥ 39.0 ℃) lasting for 3 days after the previous dose of vaccine and severe allergic reaction;
<br> - Serious adverse reactions with causal relationship with the previous dose of vaccine;
<br> - Reach the endpoint of a study;
<br> - for the subjects newly identified or newly co-curred which does not meet the inclusion criteria for the first dose or meets the exclusion criteria for the first dose after the previous dose of vaccine is vaccinated, the investigator shall determine whether they should continue to participate in the trial;
<br> - Other reasons for exclusion that investigator believes.
<br> If any of the following occurs during the trial, the relevant subjects are not required to stop the trial.
<br> - Non-specific immunoglobulins were used during the study.
<br> - Continuous oral or IV administration of steroid hormones for 14 days.
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:Investigational vaccine 1: Type of group;1 N° of participants:4000 Intervention(s) description:Inactivated SARS-CoV-2 vaccine (Vero cell)<br> Manufacturer: Wuhan Institute of Biological Products Co., Ltd.<br><br> Specification: 200WU/dose for per human use, 0.5 mL/ dose<br><br> solution for parenteral injection, intramuscular, 0.5 ml/dose, two doses (Day 0, day 21-28)<br> Group name:Placebo Type of group;2 N° of participants:4000 Intervention(s) description:Product name: Placebo/Aluminum Adjuvant of Inactivated SARS-CoV-2 vaccine<br> Active Ingredient: None; Virus Contents: None<br> Adjuvant: aluminum hydroxide<br> Manufacturer: Wuhan Institute of Biological Products Co., Ltd.<br> Specification: 0.5 mL/ dose, 0.5mL for per human use, two doses (day 0, day 21-28)<br> Solution for parenteral injection (intramuscular)<br> | <br> Outcome name:Incidence of COVID-19<br> cases after two doses of<br> vaccination through active<br> follow-up of subjects.<br> Measure:Protective effect of the<br> inactivated SARS-CoV-2<br> vaccine (Vero cell)<br> Timepoints:From 14 days after the<br> second dose to 12<br> months after the<br> second dose.<br> | | | | Yes | False | | |
| → | PER-054-20 | 12 October 2021→8 November 2021 | COVID-19: A PHASE 2A, PARTIALLY OBSERVER-BLIND, MULTICENTER, CONTROLLED, DOSE-CONFIRMATION CLINICAL TRIAL TO EVALUATE THE SAFETY, REACTOGENICITY AND IMMUNOGENICITY OF THE INVESTIGATIONAL SARS-COV-2 MRNA VACCINE CVNCOV IN ADULTS >60 YEARS OF AGE AND 18 TO 60 YEARS OF AGE | COVID-19: A PHASE 2A, PARTIALLY OBSERVER-BLIND, MULTICENTER, CONTROLLED, DOSE-CONFIRMATION CLINICAL TRIAL TO EVALUATE THE SAFETY, REACTOGENICITY AND IMMUNOGENICITY OF THE INVESTIGATIONAL SARS-COV-2 MRNA VACCINE CVNCOV IN ADULTS >60 YEARS OF AGE AND 18 TO 60 YEARS OF AGE | | CureVac AG, | 20/08/2020 | 20200820 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=054-20 | Not Recruiting | No | | | | 10/09/2020 | 270 | Interventional | <br> This is a Phase 2a, partially blind, active-controlled, dose-confirmation trial to assess the safety and immunogenicity of provisionally selected CVnCoV dose levels of 6 and 8 μg in an older adult population. The design of the trial will allow an increase or decrease in dose based on data from Trial CV-NCOV-001 and the initial phase of this trial. An overview of the planned number of subjects to be enrolled per trial group and vaccination schedules is provided in Synopsis Table 1.<br> Subjects will be recruited independent of their SARS-CoV-2 serology status. Their serostatus will be determined retrospectively by a blood sample drawn at baseline and analyzed to allow post hoc stratified analyses of subjects who are SARS-CoV-2 seronegative or seropositive at baseline.<br> Initial Phase<br> Subjects will be enrolled in 3 cohorts divided into 6 groups:<br> • 6 μg dose level cohorts<br> o Group 1 (observer-blind): CVnCoV 6 μg on Day 1 and 6 μ | II | Brazil;Panama;Peru | Elizabeth | Rospigliosi | Via Central 125, Edificio Real Ocho Piso 16, Urbanizacion Empresarial Real | rospigliosielizabeth@prahs.com | 941490447 | RPS PERU S.A.C | Inclusion criteria:
<br> Subjects will be enrolled in this trial only if they meet all of the following criteria:
<br> 1. Healthy male and female subjects ≥18 years of age.
<br> A healthy subject is defined as an individual who is in good general health, according to the Investigator’s assessment. Chronic health conditions are acceptable if the condition is considered well controlled with treatment according to the discretion of the Investigator.
<br> 2. Expected to be compliant with protocol procedures and available for clinical follow-up through the last planned visit.
<br> 3. Physical examination without clinically significant findings according to the Investigator’s assessment.
<br> 4. Body mass index (BMI) ≥18.0 and ≤30.0 kg/m2.
<br> 5. Female subjects of childbearing potential: at the time of enrollment, negative human chorionic gonadotropin (hCG) pregnancy test (serum) for women presumed to be of childbearing potential on the day of enrollment. On Day 1 (pre-vaccination): negative urine pregnancy test (required if serum pregnancy test was performed more than 3 days before).
<br> Additional information, please see the study protocol
<br> | Exclusion criteria:
<br> Subjects will not be enrolled in this trial if they meet any of the exclusion criteria.
<br> 1. Use of any investigational or non-registered product (vaccine or drug) other than the trial vaccine within 28 days preceding the administration of the trial vaccine, or planned use during the trial period.
<br> 2. Receipt of any other vaccines within 28 days prior to enrollment in this trial or planned receipt of any vaccine within 28 days of trial vaccine administration.
<br> 3. Receipt of any investigational SARS-CoV-2 or other coronavirus vaccine prior to the administration of the trial vaccine.
<br> 4. Any treatment with immunosuppressants or other immune-modifying drugs (including, but not limited to, corticosteroids, biologicals, and methotrexate) within 6 months prior to the administration of the trial vaccine or planned use during the trial, with the exception of topically-applied, inhaled, or intranasal steroids.
<br> 5. Use of hormonal therapy for gender reassignment.
<br> 6. Any medically diagnosed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination, including known human immunodeficiency virus infection, hepatitis B virus infection, and hepatitis C virus infection.
<br> Additional information, please see the study protocol
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:Arm 1 Type of group;1 N° of participants:90 Intervention(s) description:• Group 1 (6 mcg dose of CVnCoV vaccine (COVID-19 vaccine)). This group of people, from 18 to 60 years of age, will receive a 6-mcg dose of the vaccine on Day 1 and on Day 29 of the study.<br> Subject Follow up Time: 180 days (booster dose)<br><br> Group name:Arm 6 Type of group;2 N° of participants:12 Intervention(s) description:•Group 6 (control group with the pneumococcal vaccine). This group of people, 61 years of age and older, will receive an injection with the pneumococcal control vaccine on Day 1 and Day 29 of the study.<br> | <br> Outcome name:Collection of solicited local AEs (injection site pain, redness, swelling, and itching) and systemic AEs (fever, headache, fatigue, chills, myalgia, arthralgia, nausea/vomiting, and diarrhea) using diary cards (electronic or paper). In addition, other indicators of safety will be collected (e.g., body temperature).<br> Measure:Primary<br> • The frequencies, intensities, and duration of solicited local AEs on each vaccination day and the following 7 days by dose and group.<br> • The frequencies, intensities, duration, and relationship to trial vaccination of solicited systemic AEs on each vaccination day and the following 7 days by dose and group.<br> • The occurrence, intensities and relationship to trial vaccination of unsolicited AEs on each vaccination day and the following 28 days by dose and group.<br> • The occurrence and relationship to trial vaccination of SAEs and AESIs throughout the trial.<br> On Day 29 and Day 43:<br> • The proportion of subjects seroconverting for SARS-CoV-2 spike protein antibodies, as measured by enzyme-linked immunosorbent assay (ELISA).<br> • Individual SARS-CoV-2 spike protein-specific antibody levels in serum, as measured by ELISA.<br> • Geometric mean titers (GMTs) of serum SARS-CoV-2 spike protein antibodies, as measured by ELISA.<br> • The proportion of subjects seroconverting for SARS-CoV-2 neutralizing antibodies, as measured by an activity assay.Individual SARS-CoV-2 neutralizing antibody levels in serum.<br> • GMTs of serum SARS-CoV-2 neutralizing antibodies, as measured by an activity assay<br> Timepoints:day 29 and day 43<br> | | | | Yes | False | | |
| → | PER-055-20 | 12 October 2021→8 November 2021 | STUDY OF EFFICACY AND SAFETY OF DFV890 IN PATIENTS WITH COVID-19 PNEUMONIA | PHASE 2, RANDOMIZED, CONTROLLED, OPEN LABEL MULTI-CENTER STUDY TO ASSESS EFFICACY AND SAFETY OF DFV890 FOR THE TREATMENT OF SARS-COV-2 INFECTED PATIENTS WITH COVID-19 PNEUMONIA AND IMPAIRED RESPIRATORY FUNCTION | | Novartis Pharma AG., | 31/08/2020 | 20200831 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=055-20 | Recruiting | No | | | | 01/10/2020 | 20 | Interventional | <br> Screening / Baseline visit (Day -1 to 1): lasts up to a maximum of 24 hours and comprises a screening / baseline assessment<br> Treatment period (Day 1-15): Participants in the investigational treatment arm will receive DFV890 50 mg b.i.d. orally or via a nasogastric feeding tube administered for a total of 14 days (28 doses) in addition to SoC.<br> The End of Treatment (EOT) visit will take place on Day 15. If participants are discharged from the hospital prior to Day 15, assessments on the day of discharge should be performed according to the schedule listed under Day 15.<br> Follow-up (Day 16-29): After completion of the 14 day- treatment period, participants will be observed until Day 29 or discharged from hospital, whichever is sooner.<br> 30-day safety follow-up assessment (Day 45): A follow-up visit for safety will be conducted by telephone<br> | II | India;Germany;Denmark;Spain;Hungaria;South Africa;Argentina;Brazil;Mexico;Peru | Jacqueline | Giron | Jr. Juan de Arona 151, Oficinas 601-602 | jacqueline.giron@novartis.com | 986730921 | NOVARTIS BIOSCIENCES PERU S.A. | Inclusion criteria:
<br> • Male and female patients aged 18-80 years inclusive at screening
<br> • Clinically diagnosed with the SARS-CoV-2 virus by polymerase chain reaction (PCR) or by other approved diagnostic methodology within 7 days prior to randomization
<br> • Hospitalized with COVID-19-induced pneumonia evidenced by chest X-ray, computed tomography scan (CT scan) or magnetic resonance scan (MR scan), taken within 5 days prior to randomization (within 24 hours in patients in the Netherlands)
<br> • Impaired respiratory function, defined as peripheral oxygen saturation (SpO2) ≤93% on room air or partial pressure of oxygen (PaO2) / fraction of inspired oxygen (FiO2) <300 millimeter of mercury (mmHg) at screening. For cities located at altitudes greater than 2500 m above sea level, these will be substituted with SpO2 <90% and PaO2/FiO2 <250 mmHg.
<br> • APACHE II score of ≥10 at screening
<br> • C-reactive protein (CRP) ≥20 mg/L and/or ferritin level ≥600 μg/L at screening
<br> • Body mass index of ≥18 to <40kg/m2 at screening
<br> | Exclusion criteria:
<br> • Suspected active or chronic bacterial (including Mycobacterium tuberculosis), fungal, viral, or other infection (besides SARS-CoV-2)
<br> • In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
<br> • Intubated prior to randomization
<br> • Suspected active or chronic bacterial (including Mycobacterium tuberculosis), fungal, viral, or other infection (besides SARS-CoV-2)
<br> • In the opinion of the investigator, progression to death is imminent and inevitable within the next 24 hours, irrespective of the provision of treatment
<br> • Intubated prior to randomization
<br> • Previous treatment with anti-rejection and immunomodulatory drugs within the past 2 weeks, or within the past 30 days or 5 half-lives (whichever is the longer) for immunomodulatory therapeutic antibodies or prohibited drugs (see Section 6.2.1.2), with the exception of hydroxychloroquine, chloroquine or corticosteroids:
<br> • For COVID-19 infection, ongoing corticosteroid treatment is permitted at doses as per local SoC
<br> • For non-COVID-19 disorders, ongoing corticosteroid treatment is permitted at doses up to and including prednisolone 10 mg daily (or equivalent). (see Section 6.2.1)
<br> • In patients in the Netherlands only, the use of hydroxychloroquine and/or chloroquine in the past 2 weeks are exclusionary.
<br> • Serum alanine transaminase (ALT) or aspartate transaminase (AST) >5 times upper limit of normal detected within 24 hours at screening or at baseline (according to local laboratory reference ranges) or other evidence if severe hepatic impairment (Child-Pugh Class C, see Appendix 4)
<br> • Absolute peripheral blood neutrophil count of ≤1000/mm3
<br> • Estimated GFR (eGFR) ≤30 mL/min/1.73m2 (based on CKD-EPI formula)
<br> • Patients currently being treated with drugs known to be strong or moderate inducers of isoenzyme CYP2C9 and/or strong inhibitors of CYP2C9 and/or strong inducers of cytochrome P450, family 3, subfamily A (CYP3A) (see list of prohibited drugs: Section 6.2.1.2) and the treatment cannot be discontinued or switched to a different medication prior to starting study treatment
<br> • Patients with innate or acquired immunodeficiencies
<br> • Patients who have undergone solid organ or stem cell transplantation
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:DFV890 50 mg b.i.d. + standar of care Type of group;1 N° of participants:5 Intervention(s) description:• DFV890 50 mg will be administered orally twice per day approximately 12 hours apart (morning and evening).<br> • For participants unable to ingest tablets, study drug can be administered through a nasogastric tube (8 French or greater) as follows:<br> • Suspend both tablets in approximately 40 mL of water with stirring for approximately 3 minutes<br> • The suspension can then be administered through a nasogastric tube using an appropriate syringe. This needs to take place within a maximum of 6 hours of the tablets being dispersed<br> • Duration of treatment is 14 days.<br> Group name:Standar of Care Type of group;2 N° of participants:4 Intervention(s) description:The treatment is assigned considering the evaluation perfomed by the physician up to 14 days.<br> | <br> Outcome name:clinical and in-hospital outcomes, and laboratory values, including serum CRP, a key biomarker of inflammasome inhibition and safety during and after the 14-day treatment period.<br> Measure:the APACHE II score (range 0 to 71) on day 15 or on day of discharge (whichever is earlier) with worst case imputation for death as this disease severity score provides a comprehensive structured assessment of the clinical, physiological and laboratory parameters that have been routinely employed by physicians in the current situation to access the overall clinical status of COVID-19 patients with pneumonia and respiratory failure<br> Timepoints:day 15 or on day of discharge<br> | | 24/12/2020 | | Yes | False | | |
| → | PER-059-20 | 12 October 2021→8 November 2021 |
A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY IN ADULTS TO DETERMINE THE SAFETY, EFFICACY, AND
IMMUNOGENICITY OF AZD1222, A NON-REPLICATING CHADOX1 VECTOR VACCINE, FOR THE PREVENTION OF COVID-19
|
A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED MULTICENTER STUDY IN ADULTS TO DETERMINE THE SAFETY, EFFICACY, AND
IMMUNOGENICITY OF AZD1222, A NON-REPLICATING CHADOX1 VECTOR VACCINE, FOR THE PREVENTION OF COVID-19
| | AstraZeneca AB, | 17/09/2020 | 20200917 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=059-20 | Recruiting | No | | | | 03/11/2020 | 5000 | Interventional | <br> D8110C00001 is a Phase III randomized, double-blind, placebo-controlled multicenter study<br> assessing the safety, efficacy, and immunogenicity of AZD1222 compared to saline placebo<br> for the prevention of COVID-19. Participants will be adults ≥ 18 years of age who are healthy<br> or have medically-stable chronic diseases, and are at increased risk for SARS-CoV-2<br> acquisition and COVID-19. Approximately 30 000 participants will be randomized in a<br> 2:1 ratio to receive 2 IM doses of either 5 × 1010 vp (nominal, ± 1.5 × 1010 vp) AZD1222<br> (n = approximately 20 000) or saline placebo (n = approximately 10 000) 4 weeks apart, on<br> Days 1 and 29. Randomization will be stratified by age (≥ 18 and < 65 years, and ≥ 65 years),<br> with at least 25% of participants to be enrolled in the older age stratum.<br> Participants who present with at least one of the qualifying symptoms listed below through<br> Day 360 will be ass | III | United States;Peru;Chile | Paul | Toralva | AV. REPUBLICA DE PANAMA Nro. 3533, Int. 1404, Limatambo, San Isidro | Paul.Toralva@Quintiles.com | 51999484207 | IQVIA RDS Peru S.R.L | Inclusion criteria:
<br> Age
<br> 1 Adult, ≥ 18 years of age at the time of consent
<br> Type of Participant
<br> 2 Increased risk of SARS-CoV-2 infection
<br>  Defined as adults whose locations or circumstances put them at appreciable risk of
<br> exposure to SARS-CoV-2 and COVID-19, based on available risk assessment
<br> contemporaneous to enrollment (believed to be at risk/exposure)
<br> 3 Medically stable such that, according to the judgment of the investigator, hospitalization
<br> within the study period is not anticipated and the participant appears likely to be able to
<br> remain on study through the end of protocol-specified follow-upA stable medical
<br> condition is defined as disease not requiring significant change in therapy or
<br> hospitalization for worsening disease during the 3 months prior to enrollmentAble to
<br> understand and comply with study requirements/procedures (if applicable, with assistance
<br> by caregiver, surrogate, or legally authorized representative) based on the assessment of
<br> the investigator
<br> Reproduction
<br> 5 Contraceptive use by women should be consistent with local regulations regarding the
<br> methods of contraception for those participating in clinical studies
<br> 6 Female participants
<br> (a) Women of childbearing potential must:
<br>  Have a negative pregnancy test on the day of screening and on Day 1
<br>  Use one highly effective form of birth control for at least 28 days prior to Day 1
<br> and agree to continue using one highly effective form of birth control through
<br> 60 days following administration of the second dose of study intervention. A
<br> highly effective method of contraception is defined as one that can achieve a
<br> failure rate of less than 1% per year when used consistently and correctly (see
<br> Table 6). Periodic abstinence, the rhythm method, and withdrawal are NOT
<br> acceptable methods of contraception.
<br> (b) Women are considered of childbearing potential unless they meet either of the
<br> following criteria:
<br>  Surgically sterilized (including bilateral tubal ligation, bilateral oophorectomy, or
<br> hysterectomy), or
<br>  Post-menopausal
<br>  For women aged < 50 years, post-menopausal is defined as having both:
<br> o A history of ≥ 12 months amenorrhea prior to randomization, without
<br> an alternative cause, following cessation of exogenous sex-hormonal
<br> treatment, and
<br> A follicle-stimulating hormone level in the post-menopausal range
<br> Until follicle-stimulating hormone is documented to be within menopausal
<br> range, the participant is to be considered of childbearing potential
<br>  For women aged ≥ 50 years, post-menopausal is defined as having a history
<br> of ≥ 12 months amenorrhea prior to randomization, without an alternative
<br> cause, following cessation of exogenous sex-hormonal treatment
<br> Informed Consent
<br> 7 Capable of giving signed informed consent as described in Appendix A, which includes
<br> compliance with the requirements and restrictions listed in the ICF and in this protocol
<br> | Exclusion criteria:
<br> Participants are excluded from the study if any of the following criteria apply:
<br> Medical Conditions
<br> 1 History of allergy to any component of the vaccine
<br> 2 History of Guillain-Barre syndrome
<br> 3 Significant infection or other acute illness, including fever > 100 ℉ (> 37.8 °C) on the
<br> day prior to or day of randomization
<br> 4 History of laboratory-confirmed SARS-CoV-2 infection
<br> 5 Any confirmed or suspected immunosuppressive or immunodeficient state, including
<br> asplenia
<br> 6 Recurrent severe infections and use of immunosuppressant medication within the past
<br> 6 months (≥ 20 mg/kg/day of prednisone or its equivalent, given daily or on alternate days
<br> for ≥ 15 days within 30 days prior to administration of study intervention)
<br> The following exceptions are permitted:
<br>  Topical/inhaled steroids or short-term oral steroids (course lasting ≤ 14 days)
<br>  Human immunodeficiency virus-positive stable participants on stable antiretroviral
<br> therapy (Waldrop et al, 2016)
<br> 7 History of primary malignancy except for:
<br> (a) Malignancy with low potential risk for recurrence after curative treatment (for
<br> example, history of childhood leukaemia) or metastasis (for example, indolent
<br> prostate cancer) in the opinion of the site investigator.
<br> (b) Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of
<br> disease
<br> (c) Adequately treated uterine cervical carcinoma in situ without evidence of disease
<br> (d) Localized prostate cancer
<br> 8 Clinically significant bleeding disorder (eg, factor deficiency, coagulopathy, or platelet
<br> disorder), or prior history of significant bleeding or bruising following IM injections or
<br> venepuncture
<br> 9 Severe and/or uncontrolled cardiovascular disease, respiratory disease, gastrointestinal
<br> disease, liver disease, renal disease, endocrine disorder, and neurological illness, as
<br> judged by the Investigator (mild/moderate well-controlled comorbidities are allowed)
<br> 10 Any other significant disease, disorder, or finding that may significantly increase the risk
<br> to the participant because of participation in the study, affect the ability of the participant
<br> to participate in the study, or impair interpretation of the study data
<br> Prior/Concomitant Therapy
<br> 11 Receipt of, or planned receipt of investigational products indicated for the treatment or
<br> prevention of SARS-CoV-2 or COVID-19
<br> Note: For participants who become hospitalized with COVID-19, receipt of licensed
<br> treatment options and/or participation in investigational treatment studies is permitted
<br> 12 Receipt of any vaccine (licensed or investigational) other than licensed influenza vaccines
<br> within 30 days prior to and after administration of study intervention
<br> 13 Receipt of immunoglobulins and/or any blood products within 3 months prior to
<br> administration of study intervention or expected receipt during the period of study
<br> follow-up
<br> Other Exclusions
<br> 14 Involvement in the planning and/or conduct of this study (applies to both Sponsor staff
<br> and/or staff at the study site)
<br> 15 For women only - currently pregnant (confirmed with positive pregnancy test) or
<br> breast-feeding
<br> 16 Has donated ≥ 450 mL of blood products within 30 days prior to randomization or
<br> expects to donate blood within 90 days of administration of s |
-J98
;J98 | <br> Group name:GROUP 1: AZD1222 ≥ 0.7 X 10 11 PV/ML 5 ML VIAL IM Type of group;1 N° of participants:20000 Intervention(s) description:Participants will receive 2 doses of either AZD1222 (≥ 0,7 × 1011 pv/ml)); the first dose will be administered on Day 1 and the second dose on Day 29.<br> It is recommended that the study interventions be administered as an IM injection into the deltoid of the non-dominant arm. Other injection sites may be used if necessary.<br> All study participants will be observed in the clinic for at least 15 minutes after vaccination.<br> Each vial of AZD1222 has a label-claim volume of 5mL and can provide up to ten 0.5mL doses.<br> Each dose is prepared by withdrawing 0.5mL from a vial of AZD1222 in a sterile 1 mL or equivalent syringe.<br> Group name:GROUP 2: PLACEBO FOR AZD1222 Type of group;2 N° of participants:10000 Intervention(s) description:Participants will receive 2 doses of placebo (0.5ml); the first dose will be administered on Day 1 and the second dose on Day 29. It is recommended that the study interventions be administered as an IM injection into the deltoid of the non-dominant arm. Other injection sites may be used if necessary. All study participants will be observed in the clinic for at least 15 minutes after vaccination<br> | <br> Outcome name:RT-PCR-confirmed SARS-CoV-2<br> Measure:A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case.<br> Timepoints:one year<br> ;<br> Outcome name:EA reports<br> Measure:a)Incidence of adverse events.<br> b)Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.<br> Timepoints:28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730<br> ;<br> Outcome name:Solicited AE e-Diary<br> Measure:Incidence of local and systemic solicited adverse events.<br><br> Timepoints:7 days post each dose of study intervention<br> →<br> Outcome name:Solicited AE e-Diary<br> Measure:Incidence of local and systemic solicited adverse events.<br><br> Timepoints:7 days post each dose of study intervention<br> ;<br> Outcome name:EA reports<br> Measure:a)Incidence of adverse events.<br> b)Incidence of serious adverse events, medically attended adverse events, and adverse events of special interest.<br> Timepoints:28 days post each dose of study Intervention. / b: from Day 1 post-treatment through Day 730<br> ;<br> Outcome name:RT-PCR-confirmed SARS-CoV-2<br> Measure:A binary response, whereby a participant is defined as a COVID-19 case if their first case of SARS-CoV-2 RT-PCR-positive symptomatic illness occurs≥ 15 days post second dose of study intervention. Otherwise, a participant is not defined as a COVID-19 case.<br> Timepoints:one year<br> | | | | Yes | False | | |
| → | PER-060-20 | 12 October 2021→8 November 2021 |
RANDOMIZED PHASE 2 CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF THE USE OF PLASMA FROM CONVALESCENT PATIENTS WITH THE NEW CORONAVIRUS DISEASE (COVID-19) FOR THE EXPERIMENTAL TREATMENT OF PATIENTS HOSPITALIZED IN THE CENTRO MEDICO NAVAL "CIRUJANO MAYOR SANTIAGO TAVARA"
"
|
RANDOMIZED PHASE 2 CLINICAL TRIAL TO EVALUATE SAFETY AND EFFICACY OF THE USE OF PLASMA FROM CONVALESCENT PATIENTS WITH THE NEW CORONAVIRUS DISEASE (COVID-19) FOR THE EXPERIMENTAL TREATMENT OF PATIENTS HOSPITALIZED IN THE CENTRO MEDICO NAVAL "CIRUJANO MAYOR SANTIAGO TAVARA"
| | Marina de Guerra del Peru, | 21/09/2020 | 20200921 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=060-20 | Recruiting | No | | | | 07/09/2020 | 100 | Interventional | <br> Phase 2 clinical trial, randomized 1:1, open label; which is intended to evaluate the safety and efficacy of experimental treatment with COVID-19 convalescent plasma in patients with SARS-CoV-2 infection. Two arms will be available, with the experimental group receiving convalescing plasma plus standard hospital treatment; while the control group will receive standard treatment. This study will be carried out in two phases: Collection phase: The system of donor awareness and recruitment, collection, study and storage of convalescing plasma will be established. It is estimated to collect plasma from 50 patients recovered from COVID-19 centrally. Experimental Treatment Phase: It will start as soon as the first units of Convalescent Plasma are available, the experimental group will receive 1 to 2 units of 200mL of plasma (ABO, Rh compatible), obtained according to the established criteria, for the treatment of patients hospitalized by COVID-19.<br> | II | Peru | Mario | Ortiz | AV. LA MARINA CDRA 36 NRO. S/N CUARTEL LA PERLA (AV. LA MARINA CDRA. 36 ESQ. INSURGENTES) | ortiz60marina51@hotmail.com | 997530194 | Marina de Guerra del Peru | Inclusion criteria:
<br> • Patients over 18 years of age from both sexes hospitalized at the Centro Medico Naval.
<br> • Be in the disposition and capacity to give free and informed consent, or have a relative or tutor with the capacity to do so (Appendix 2)
<br> • Be in the disposition and capacity to undergo clinical evaluations and diagnosis procedures.
<br> • Previous COVID-19 diagnosis supported by a laboratory test (PCR-RT or by the presence of SARS-CoV-2 antibodies).
<br> • Diagnosis of moderate to severe Acute Respiratory Distress Syndrome, according to the definition of the Berlin criteria during a span of less than 10 days.
<br> • Need of mechanical ventilation or continuous oxygenation at positive pressure.
<br> | Exclusion criteria:
<br> • Diagnosis of Mild Acute Respiratory Distress Syndrome according to the definition of the Berlin criteria.
<br> • Diagnosis of moderate to severe Acute Respiratory Distress Syndrome, according to the definition of the Berlin criteria, lasting more than 10 days.
<br> • Demonstrated hypersensitivity or history of allergy to blood products or immunoglobulins.
<br> • Pregnant or breastfeeding women
<br>
<br>
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:Experimental Type of group;1 N° of participants:100 Intervention(s) description:A 200 ml unit of COVID 19 convalescent donor s plasma will be transfused considering ABO and Rh compatibility through an intravenous line up to 2 times spaced 24 hours apart.<br><br> | <br> Outcome name:It is defined as an event of death due to the 2019 Coronavirus disease or another cause that occurred between the start of treatment until day 60.<br> Measure:Mortality<br> Timepoints:60 days from the first day of treatment.<br> | | | | No | False | | |
| → | PER-064-20 | 12 October 2021→8 November 2021 | LACTOFERRIN FOR PREVENTION OF COVID-19 IN HEALTH CARE PERSONNEL. | BOVINE LACTOFERRIN FOR THE PREVENTION OF COVID-19 INFECTION IN PHYSICIANS AND NURSES IN HOSPITALS IN LIMA, PERU: A DOUBLE BLINDED RANDOMIZED CLINICAL TRIAL | | UNIVERSIDAD PERUANA CAYETANO HEREDIA, | 29/09/2020 | 20200929 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=064-20 | Recruiting | No | | | | 01/10/2020 | 336 | Interventional | This is a randomized, stratified, double-blind, placebo-controlled clinical trial comparing daily oral supplementation of bovine lactoferrin versus placebo (maltodextrin) in physicians, nurses, and technical nursing personnel, to assess the reduction in the number of COVID-19 infections. The participant, principal investigator, study physicians, data typing personnel, laboratory personnel, and statistician will remain "blind" to each participant´s treatment allocation. | II | Peru | Theresa Jean | Ochoa | Av. Honorio Delgado 430 | theresa.ochoa@upch.pe | 996505308 | UNIVERSIDAD PERUANA CAYETANO HEREDIA | Inclusion criteria:
<br> 1.- Man or woman over 18 and under 60 years old.
<br> 2.- Physicians or nurses who work in areas of care for patients with COVID-19 (emergency, hospitalization, and ICU) in hospitals in Lima, Peru.
<br> 3.- Healthy participants, without COVID-19 suggestive symptoms.
<br> 4.- Participant who wants to participate and signs the informed consent.
<br>
<br> | Exclusion criteria:
<br> 1.- Participant who had a previous diagnosis of COVID-19.
<br> 2.- Participant positive in the initial screening for IgM or IgG positive RT-PCR for COVID-19.
<br> 3.- Participant with the following comorbidities: hypertension, coronary heart disease, diabetes mellitus, obesity, chronic lung disease, cancer, kidney failure, or other hematological /and immunosuppressive diseases.
<br> 4.- Pregnant woman.
<br> 5.- Participant that are part of another clinical trial or is receiving any supplement or preventive treatment for COVID 19.
<br> 6.- Participant with known allergy to cow´s milk protein.
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:Bovine Lactoferrin Type of group;1 N° of participants:168 Intervention(s) description:Bovine Lactoferrin 300 mg every twelve hours for 12 weeks.<br> Presentation: 100mg chewable tablets.<br><br> Group name:Maltodextrin Type of group;2 N° of participants:168 Intervention(s) description:Maltodextrin 300 mg every twelve hours for 12 weeks<br> Presentation: 100mg chewable tablets.<br><br> | <br> Outcome name:Serology (IgM or IgG) or RT-PCR for COVID-19<br> Measure:Number of COVID-19 infections<br> Timepoints:Serology every 4 weeks and RT-PCR if you have symptoms suggestive of COVID-19<br> | | 05/03/2021 | | Yes | False | | |
| → | PER-067-20 | 12 October 2021→8 November 2021 | A DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, MULTI CENTER STUDY OF OT 101 IN HOSPITALIZED COVID 19 SUBJECTS | A DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, MULTI CENTER STUDY OF OT 101 IN HOSPITALIZED COVID 19 SUBJECTS | | Oncotelic Inc., | 29/10/2020 | 20201029 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=067-20 | Not Recruiting | No | | | | 18/09/2020 | 48 | Interventional | <br> This is a randomized, double blind, placebo controlled study to evaluate the efficacy, safety and tolerability of OT 101 when used in combination with SoC in hospitalized subjects with mild or severe COVID 19. Written informed consent must be obtained from all subjects or their legally authorized representative (LAR) during screening (up to Day 3 prior to dosing) and prior to study related procedures being performed. Following completion of all screening assessments and meeting of eligibility criteria, subjects will be enrolled in Part 1 (subjects with mild COVID 19) or Part 2 (subjects with severe COVID 19) and randomized on Day 1 to either receive OT 101 or placebo in a 2:1 ratio for 7 days in combination with SoC therapy per local SoC policies, followed to Day 28.<br> The study has 2 parts for subjects to be enrolled in parallel.<br> Part 1 includes subjects with mild COVID 19 (World Health Organization [WHO] COVID 19 Clinical Improvement Ordinal Scale 3 – hospi | II | Argentina | Flor de Liz | Jacome | Calle Monte Rosa N° 255, Piso 4 - Chacarilla del Estanque | liz.jacome@covance.com | 987507623 | COVANCE PERU SERVICES S.A. | Inclusion criteria:
<br> Each subject must meet all of the following criteria to be eligible for study participation: Part 1:
<br> 1. Hospitalized adult male or non-pregnant, non-lactating female subjects (between 18 and 80 years), with SARS-CoV-2, previously known as novel coronavirus (2019-nCoV) infection that is documented by an authorized diagnostic PCR test. A rapid PCR test could also be used. Confirmation that subject has COVID 19 within the last 1 week prior to randomization. 2. Meeting WHO COVID 19 Clinical Improvement Ordinal Scale Criteria 3 (hospitalized, no oxygen therapy) or Criteria 4 (hospitalized, oxygen by mask or nasal prongs). 3. Having at least 1 medical risk factor, i.e. having absolute lymphocyte count <1000 cells/mm3, age >60 years, hypertension, diabetes, cardiac failure or COPD. 4. Male subjects and female subjects of childbearing potential must agree to use protocol specified methods of contraception. 5. Females subjects of childbearing potential and women of non childbearing potential (defined as at least 2 years postmenopausal or permanently sterilized women [bilateral tubal ligation, bilateral ovariectomy, or hysterectomy]) must have a negative serum pregnancy test at screening or pretreatment on Day 1. 6. The subject or a LAR has provided written informed consent. 7. The subject or the LAR is aware of the investigational nature of this study and willing to comply with protocol treatments, blood tests, and other evaluations listed in the ICF. Part 2: Same as part 1 except 1.Meeting WHO COVID 19 Clinical Improvement Ordinal Scale Criteria 5 (non-invasive mechanical ventilation or high-flow oxygen) or Criteria 6 (intubation and mechanical ventilation).
<br> | Exclusion criteria:
<br> Subjects (in Part 1 and Part 2) who meet any of the following criteria must be excluded from the study: 1. Participation in any other clinical trial of an experimental treatment for COVID-19 or participation in another interventional clinical trial, including an expanded access trial. 2. Concurrent treatment with other agents with actual or possible direct acting antiviral activity against SARS CoV 2 infection <24 hours prior to study drug dosing except for remdesivir. 3. Uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), unstable angina, congestive heart failure of any New York Respiratory Association classification, serious cardiac arrhythmia requiring treatment (exceptions: atrial fibrillation, paroxysmal supraventricular tachycardia), or history of myocardial infarction within 12 months of enrollment. 4. Hypotension requiring vasoactive peptides, such as dopamine, norepinephrine, epinephrine, or dobutamine. 5. Renal function impairment (creatinine clearance [Cr. Cl.] <50 mL/min, based on Modification of Diet in Renal Disease calculation).
<br> 6. Liver function impairment a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × upper limit of normal (ULN), or ALT/AST >3 × ULN plus total bilirubin >2 × ULN. b. Total bilirubin >1.5 × ULN, unless the subject has known Gilbert’s syndrome. 7. Platelet count <50 000/µL 8. Multi-organ failure.
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:OT-101 Type of group;1 N° of participants:48 Intervention(s) description:Name of the IMP: OT 101 (Trabedersen, TGF-β2 specific synthetic 18 mer phosphorothioate antisense oligodeoxynucleotide).<br> Dose and dosage regimen:<br> Days 1 to 7: 140 mg/m2 daily intravenous (i.v.) infusion for 7 continuous days.<br> Formulation: Lyophilized powder.<br> Group name:Placebo Type of group;2 N° of participants:24 Intervention(s) description:Dose and dosage regimen: Days 1 to 7 daily i.v. infusion for 7 continuous days.<br> Formulation: Saline solution<br> | <br> Outcome name:An 8 point WHO COVID 19 Clinical Improvement Ordinal Scale) as assessed by the odds ratio (OR)<br> Measure:The proportion of subjects with clinical improvement score measured by an 8 point WHO COVID 19 Clinical Improvement Ordinal Scale) as assessed by the odds ratio (OR) at Day 14.<br> Clinical improvement is defined as<br> • A score decrease of at least 1 in subjects with mild COVID 19.<br> • A score decrease to categories 1, 2, 3, or 4 in subjects with severe COVID 19.<br> Timepoints:Day 14<br> | | →14/06/2021 | | No | False | | |
| +++ | PER-069-20 | 8 November 2021 | “A PHASE 2/3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND THE SAFETY OF ABX464 IN TREATING INFLAMMATION AND PREVENTING COVID-19 ASSOCIATED ACUTE RESPIRATORY FAILURE IN PATIENTS AGED ≥ 65 AND PATIENTS AGED ≥18 WITH AT LEAST ONE ADDITIONAL RISK FACTOR WHO ARE INFECTED WITH SARS-COV-2. (THE MIR-AGE STUDY).” | “A PHASE 2/3, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND THE SAFETY OF ABX464 IN TREATING INFLAMMATION AND PREVENTING COVID-19 ASSOCIATED ACUTE RESPIRATORY FAILURE IN PATIENTS AGED ≥ 65 AND PATIENTS AGED ≥18 WITH AT LEAST ONE ADDITIONAL RISK FACTOR WHO ARE INFECTED WITH SARS-COV-2. (THE MIR-AGE STUDY).” | | ABIVAX S.A., | 05/10/2020 | 20201005 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=069-20 | Not Recruiting | No | | | | 15/10/2020 | 100 | Interventional | <br> Study design:<br> The study will consist of 3 periods:<br> • Treatment phase: randomized patients will be treated for 28 days<br> • Safety follow-up phase of 21 days<br> • Exploratory follow-up of the pulmonary function 3 months after the last study drug intake.<br> From Day 0 onwards, randomized patients will be followed by the investigational site at 7 days (D7 +/- 2 days), 14 days (D14 +/- 2 days), 21 days (D21+/- 2 days) and finally 28 days (D28 +/- 2 days) after randomization.<br> Should a patient be hospitalized at D0, Day 7 visit will be an on-site visit.<br> Should a patient not be hospitalized, considering a quarantine period might be applied for infected patients, a remote medical monitoring will be performed by the investigator or his designee every 2 days from D0 and until D14. Every attempt to perform the Day 7 on-site visit should be made anyway. For outpatients, an oximeter will be provided at Day 0. During the remote medical monitoring, | II | Czech Republic;United Kindgdom;Poland;Italy;Hungary;France;Spain;Slovenia;Slovakia;Belgium;Austria;Germany | Rosmery | Osorio | Calle Amador Merino Reyna N° 307, Of. 1401 | rosmery.osorioubaldo@parexel.com | 423-1923 | PAREXEL INTERNATIONAL (PERU) S.A. | Inclusion criteria:
<br> 1. Adult (≥ 18 years old) men or women, hospitalized or not hospitalized, diagnosed for SARS-CoV-2 infection by PCR (within 48 hours prior to randomization), with at least one associated risk factor. Considered risk factors are:
<br> • Age ≥ 65 years
<br> • Obesity defined as BMI ≥ 30
<br> • Recent history of uncontrolled High Blood Pressure
<br> • Treated diabetes (type I or II)
<br> • History of ischemic cardiovascular disease
<br> 2. Symptomatic patients must present at least 1 of the following symptoms at enrollment: fever or perceived fever
<br> for more than 24 hours, headache, sore throat, dry cough, fatigue, chest pain or choking sensation (with no
<br> associated respiratory distress), myalgia, anosmia, ageusia, or gastro-intestinal symptoms.
<br> 3. Patients with pulse oximetry arterial saturation (SpO2) ≥ 92 % on room air at enrolment.
<br> 4. Patients with the following hematological and biochemical laboratory parameters obtained within 7 days prior
<br> to D0:
<br> • Hemoglobin > 9.0 g dL-1
<br> • Absolute Neutrophil Count ≥ 1000 mm-3;
<br> • Platelets ≥ 100,000 mm-3;
<br> • Creatinine clearance ≥ 50 mL min-1 by the Cockcroft-Gault formula
<br> • Total serum bilirubin < 2 x ULN
<br> • Alkaline phosphatase< 2 x ULN, AST (SGOT) and ALT (SGPT) < 3 x ULN;
<br> 5. Women of childbearing potential and men receiving the study treatment and their partners must agree to use a highly effective contraceptive method during the study and for 6 months (180 days) after end of study or early termination. Contraception should be in place at least 2 weeks prior to enrolment. Women must be surgically sterile or if of childbearing potential must use a highly effective contraceptive method. Women of childbearing potential (WOCBP) will enter the study after confirmed menstrual period and a negative pregnancy test.
<br> 6. Patients must understand, sign and date the written voluntary informed consent form at the visit prior to any protocol-specific procedures.
<br> 7. Patients able and willing to comply with study visits and procedures as per protocol.
<br> 8. Patients should be affiliated to a social security regimen (for French sites only).
<br> | Exclusion criteria:
<br> Patients who meet any of the following exclusion criteria will be excluded from the study:
<br> 1. Patients with moderate or severe acute respiratory failure or requiring noninvasive ventilation or oxygen or with SpO2 < 92% or tachypnea (respiratory rate ≥ 30 breaths/min).
<br> 2. Patients treated with immunosuppressors and/or immunomodulators (cf. Appendix #2).
<br> 3. Engrafted patients (organ and/or hematopoietic stem cells).
<br> 4. Patients with uncontrolled auto-immune disease.
<br> 5. Patients with known or suspected active (i.e. not controlled) bacterial, viral (excluding COVID-19) or fungal infections.
<br> 6. Patients with preexisting, severe and not controlled organ failure.
<br> 7. History or active malignancy requiring chemotherapy or radiation therapy (excluding 2 years disease free survivor patients).
<br> 8. Pregnant or breast-feeding women.
<br> 9. Illicit drug or alcohol abuse or dependence that may compromise the patient´s safety or adherence to the study protocol.
<br> 10. Use of any investigational or non-registered product within 3 months or within 5 half-lives preceding baseline, whichever is longer.
<br> 11. Hypersensitivity to ABX464 and/or its excipients.
<br> 12. Any condition, which in the opinion of the investigator, could compromise the patient´s safety or adherence to the study protocol.
<br> |
-J22 Unspecified acute lower respiratory infection
<br>Unspecified acute lower respiratory infection;J22 ;Unspecified acute lower respiratory infection | <br> Group name:double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing COVID-19 associated acute respiratory failure in patients aged ≥ 65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2. (the MiR-AGE study). Type of group;2 N° of participants:100 Intervention(s) description:The ABX464 investigational medicinal product (IMP) is a hard gelatin capsule intended for oral administration.<br> For the proposed clinical trial, the IMP consists of size 01 capsules containing 50mg of ABX464 drug substance in the form of granulate prepared with several common excipients (microcrystalline cellulose, polyvinylpyrrolidone, magnesium stearate and colloidal silica).<br> It is supplied in study specific high-density polyethylene bottles containing 30 capsules.<br> ABX464 will be manufactured by:<br> DELPHARM Lille SAS<br> Parc d’activite Roubaix Est<br> 22, rue de Toufflers<br> CS 50070<br> 59 452 Lys-Lez-Lannoy France<br> Packaging and labelling activities, as well as Qualified Person release of the IMP will be performed at the following site:<br> Creapharm Clinical Supplies<br> Z.A. Air Space<br> Avenue de Magudas CS 2007<br> 33187 Le Haillan Cedex France<br> Storage conditions: Do not store above 30°C (86°F). Do not refrigerate or freeze.<br> Group name:double blind, placebo-controlled study to evaluate the efficacy and the safety of ABX464 in treating inflammation and preventing COVID-19 associated acute respiratory failure in patients aged ≥ 65 and patients aged ≥18 with at least one additional risk factor who are infected with SARS-CoV-2. (the MiR-AGE study). Type of group;2 N° of particip | <br> Outcome name:Rate of patients who do not require use of high-flow oxygen (use of high-flow oxygen being defined as settings of 3 L/min or greater AND with at least one SpO2 measurement < 92%, with or without O2 supplementation) or, invasive or non-invasive mechanical ventilation (IMV and NIV, respectively) within 28 days and who are alive at the end of the 28 days period.<br> Measure:Rate of patients who do not require use of high-flow oxygen (use of high-flow oxygen being defined as settings of 3 L/min or greater AND with at least one SpO2 measurement < 92%, with or without O2 supplementation) or, invasive or non-invasive mechanical ventilation (IMV and NIV, respectively) within 28 days and who are alive at the end of the 28 days period.<br> Timepoints:Day 28<br> | | 26/03/2021 | | Yes | False | | |
| → | PER-084-20 | 12 October 2021→8 November 2021 | ADAPTATIVE PLATFORM TREATMENT TRIAL FOR OUTPATIENTS WITH COVID-19 (ADAPT OUT COVID) | ADAPTATIVE PLATFORM TREATMENT TRIAL FOR OUTPATIENTS WITH COVID-19 (ADAPT OUT COVID) | | Instituto Nacional de Alergias y Enfermedades Infecciosas (NIAID). EEUU, | 27/11/2020 | 20201127 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=084-20 | Not Recruiting | No | | | | 18/12/2020 | 80 | Interventional | <br> Adapt Out COVID is a master protocol to evaluate the safety and efficacy of investigational agents for the treatment of symptomatic non-hospitalized adults with COVID-19. It begins with a phase II evaluation, followed by a transition into a larger phase III evaluation for promising agents.<br> The trial is a randomized, blinded, controlled adaptive platform that allows agents to be added and dropped during the course of the study for efficient testing of new agents against placebo within the same trial infrastructure. When two or more new agents are being tested concurrently, the same placebo will be used, if feasible.<br> The primary outcome measures in the phase II evaluation will be duration of symptoms, similar to the outcome used for outpatient influenza studies, loss of detection of SARS-CoV-2 RNA by nasopharyngeal (NP) swab, and safety. Determination of whether a phase II agent will continue to be evaluated in phase III will be made after the last participant | II | United States;Mexico;Chile;Canada;Brazil;Argentina;Uganda;South Africa;Kenya;Australia;India;Philippines | Dario | Diaz | Av. Republica de Panama 3461, Interior 1801 Urb. El palomar | dario.diaz@ppdi.com | 967767545 | PPD Peru S.A.C. | Inclusion criteria:
<br> 1) Ability and willingness of participant (or legally authorized representative) to provide informed consent.
<br> 2) Individuals ≥18 years of age.
<br> 3) Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (e.g., oropharyngeal, NP, or nasal swab, or saliva) collected ≤168 hours prior to study entry.
<br> 4) Participants must be expected to begin study treatment no more than 10 days from self-reported onset of COVID-19 related symptoms or measured fever.
<br> 5) One or more of the following signs/symptoms present within 48 hours prior to study entry (fever, cough, shortness of breath or difficulty breathing, sore throat, body pain, fatigue, headache, etc.)
<br> 6) Oxygenation saturation of ≥92% obtained at rest by study staff within 48 hours prior to study entry.
<br> 7) Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days post-entry
<br> 8) Additional inclusion criteria as appropriate for the investigational agent.
<br> For more details check the protocol.
<br> | Exclusion criteria:
<br> 1) History of or current hospitalization for COVID-19
<br> 2) Current need for hospitalization or immediate medical attention in the clinical opinion of the site investigator.
<br> 3) Use of any prohibited medication listed in the protocol within 30 days prior to study entry.
<br> 4) Receipt of convalescent COVID-19 plasma treatment at any time prior to study entry.
<br> 5) Receipt of a SARS-CoV-2 vaccine at any time prior to study entry.
<br> 6) Receipt of other available investigational treatments for SARS-CoV-2 at any time prior to study entry.
<br> 7) Receipt of systemic steroids (e.g., prednisone, dexamethasone) or inhaled steroids within 30 days prior to study entry
<br> 8) Known allergy/sensitivity or any hypersensitivity to components of the investigational agent or placebo
<br> 9) Any co-morbidity requiring surgery within 7 days prior to study entry
<br> 10) Additional exclusion criteria as appropriate for the investigational agent.
<br> For more details check the protocol.
<br> |
-J39
;J39 | <br> Group name:LY3819253 Type of group;1 N° of participants:1000 Intervention(s) description:Participants in this study will be randomized to receive the research product, administered by intravenous infusion.<br> Group name:Placebo de LY3819253 Type of group;2 N° of participants:1000 Intervention(s) description:Participants in this study will be randomized to receive the placebo of LY3819253 (0.9% Sodium Chloride Solution), administered by intravenous infusion.<br> | <br> Outcome name:New Grade 3 or higher<br> AE through 28 days<br> Measure:Safety: New grade 3<br> o higher AE (Phase 3)<br> Timepoints:Through 28 days<br> ;<br> Outcome name:Death from any cause<br> or hospitalization<br> during the 28-day<br> period from and<br> including the day of<br> the first dose of<br> investigational agent<br> or placebo.<br> Hospitalization is<br> defined as ≥24 hours<br> of acute care, in a<br> hospital or similar<br> acute care facility,<br> including Emergency<br> Rooms or temporary<br> facilities instituted to<br> address medical needs<br> of those with severe<br> COVID-19 during the<br> COVID-19 pandemic<br> Measure:Efficacy: Death from<br> any cause or<br> hospitalization during<br> the 28-day period<br> from and including<br> the day of the first<br> dose of<br> investigational agent<br> or placebo. (Phase 3)<br> Timepoints:During the 28-day<br> period from and<br> including the day of the<br> first dose<br> ;<br> Outcome name:New Grade 3 or higher<br> AE through 28 days.<br> Measure:Safety: New Grade 3<br> o higher (Phase 2)<br> Timepoints:Through 28 days.<br> ;<br> Outcome name:At each of days 3, 7,<br> 14, 21 and 28,<br> detection (detectable<br> versus undetectable)<br> of SARS-CoV-2 RNA<br> from site-collected NP<br> swabs.<br> Measure:Virologic: Detection<br> of SARS-CoV-2 RNA<br> (Phase 2)<br> Timepoints:Days 3, 7, 14, 21 and<br> 28.<br> ;<br> Outcome name:Duration of targeted<br> COVID-19 associated<br> symptoms from start<br> of investigational<br> agent (day 0) based<br> on self-assessment.<br> Duration defined as<br> the last day on or<br> before study day 28<br> when any symptoms<br> scored as moderate or<br> severe at study entry<br> (pre-treatment) are<br> still scored as<br> moderate or severe<br> (i.e., not mild or<br> absent), or any<br> symptoms scored as<br> mild or absent at study<br> entry are scored as<br> mild or worse (i.e., not<br> absent). The targeted<br> symptoms are fever or<br> feeling feverish, cough,<br> shortness of breath or<br> difficulty breathing at<br> rest or with activity,<br> sore throat, body pain<br> or muscle pain/aches,<br> fatigue, headache,<br> chills, nasal<br> obstruction or<br> congestion, nasal<br> discharge (runny<br> nose), nausea or<br> vomiting, and<br> diarrhea. Each<br> symptom is scored<br> daily by the participant<br> as absent (score 0),<br> mild (1) moderate (2)<br> and severe (3).<br> Measure:Clinical: Duration of<br> COVID-19 symptoms<br> (Phase 2)<br> Timepoints:Up to Day 28<br> | | | | Yes | False | | |
| +++ | PER-090-20 | 8 November 2021 | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF OF CONCEPT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ANTROQUINONOL IN HOSPITALIZED PATIENTS WITH MILD TO MODERATE PNEUMONIA DUE TO COVID-19 | A PHASE 2 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF OF CONCEPT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ANTROQUINONOL IN HOSPITALIZED PATIENTS WITH MILD TO MODERATE PNEUMONIA DUE TO COVID-19 | | Golden Biotechnology Corporation, | 16/12/2020 | 20201216 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=090-20 | Recruiting | No | | | | 19/12/2020 | 50 | Interventional | <br> This is a randomized, double blind, placebo controlled, Phase 2, proof of concept study in hospitalized patients with mild to moderate pneumonia due to COVID 19. Following completion of all screening assessments and meeting of eligibility criteria, patients will either receive antroquinonol or placebo for 14 days in combination with standard of care therapy.<br> A total of 174 patients are planned to be randomized in a 1:1 ratio to antroquinonol or placebo.<br> The study will consist of a sentinel cohort of 20 patients (10 patients randomized to antroquinonol and 10 patients to placebo), and an expansion cohort of 154 patients (77 patients in each treatment group). Enrollment will pause after the 20th patient in the sentinel cohort has been enrolled. Once the 20th patient in the sentinel cohort has completed 14 days of treatment, an unblinded Independent Data Monitoring Committee will assess the safety, tolerability, and efficacy data. The DMC will issue a recommenda | II | United States;Peru;Argentina | Flor de Liz | Jacome | Calle Monte Rosa N° 255, Piso 4 - Chacarilla del Estanque | liz.jacome@covance.com | 9875 07623 | COVANCE PERU SERVICES S.A. | Inclusion criteria:
<br> 1. Willing and able to provide informed consent.
<br> 2. Male or female patients between 18 and 80 years of age.
<br> 3. Hospitalized with mild COVID-19 disease (not requiring oxygen therapy [WHO COVID-19 Clinical Improvement Ordinal Scale, score of 3] or requiring oxygen therapy by mask or nasal prong [WHO COVID-19 Clinical Improvement Ordinal Scale, score of 4]).
<br> Note: Hospitalized patients can also include patients admitted to centers conditioned as hospitals to treat COVID-19 patients.
<br> 4. Chest x- ray or computerized tomography (CT) scan consistent with pneumonia.
<br> 5. Onset of COVID-19 symptoms within 2 weeks prior to randomization.
<br> 6. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection confirmed by a polymerase chain reaction (PCR) test (nasopharyngeal, oropharyngeal, or respiratory samples, not serology testing).
<br> 7. Male patients and female patients of childbearing potential must agree to use protocol-specified methods of contraception.
<br> 8. Female patients of childbearing potential must have a negative pregnancy test at Screening or pretreatment on Day 1.
<br> 9. Male patients must agree not to donate sperm from the first dose through 90 days after the last dose of study treatment; female patients of childbearing potential should refrain from donation of ova from Day 1 until 90 days after the last dose of study treatment.
<br> 10. Patient is, in the opinion of the investigator, willing and able to comply with the study treatment regimen and all other study requirements.
<br> | Exclusion criteria:
<br> 1. Female patient is pregnant or breastfeeding.
<br> 2. Any patient’s concomitant life-threatening condition, including but not limited to: requiring mechanical ventilation, acute respiratory distress syndrome, shock, or cardiac failure.
<br> 3. Evidence of multi-lobar consolidation pneumonia or cavities on chest x-ray or CT scan.
<br> 4. Severe COVID-19 disease as defined by the WHO COVID-19 Clinical Improvement Ordinal Scale, scores of 5 (non-invasive ventilation or high-flow oxygen), 6 (intubation and mechanical ventilation), or 7 (ventilation + additional organ support-pressors, renal replacement therapy, ECMO).
<br> 5. Medical history significant for the following pulmonary diseases: lung cancer, cystic fibrosis, empyema.
<br> 6. Respiratory rate >30 respirations per minute.
<br> 7. History of abuse of drugs or alcohol that could interfere with adherence to study requirements, as judged by the investigator.
<br> 8. Treatment with other drugs thought to possibly have activity against COVID-19 within 7 days prior to enrollment or concurrently. Note: remdesivir or other authorized treatments for COVID-19 is allowed if considered SoC, if started prior to randomization or during the study.
<br> 9. Use of other investigational drugs within 30 days of dosing, or plans to enroll in another clinical trial of an investigational agent while participating in the present study.
<br> 10. Use of Antrodia camphorata -containing products within 2 weeks prior to the first administration of study drug.
<br> 11. Clinically significant abnormal electrocardiogram (ECG) at Screening, as determined by the investigator.
<br> 12. Patient requires frequent or prolonged use of systemic corticosteroids (≥20 mg of prednisone/day or equivalent for >4 weeks) or other immunosuppressive drugs (e.g., for organ transplantation or autoimmune conditions).
<br> 13. Abnormal laboratory values at Screening:
<br> a. Estimated glomerular filtration rate <50 mL/min.
<br> b. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 × upper limit of normal (ULN), or ALT/AST >3 × ULN plus total bilirubin >2 × ULN.
<br> c. Total bilirubin >1.5 × ULN, unless the patient has known Gilbert’s syndrome.
<br> d. Hemoglobin <9 g/dL for females or <11 g/dL for males.
<br> e. Absolute neutrophil count <1,500/mm3.
<br> f. Thrombocytopenia (platelets count <100 × 109/L).
<br> 14. Treatment with any antiviral drugs (except remdesivir or other authorized treatments for COVID-19), or with any drugs known to be strong inducers or inhibitors of cytochrome P450 isoform (CYP) 2C19, CYP3A4, CYP2C8, and CYP2E1 within 14 days or 5 half-lives prior to the start of study treatment. Drugs with a narrow therapeutic index that are substrates of 1A2, 2B6, 2C8, 2C9, 2C19, 3A, and 2D6 are also prohibited.
<br> 15. Inability to swallow oral medications or a gastrointestinal disorder with diarrhea (e.g., Crohn’s disease), malabsorption, or diarrhea of any etiology at baseline.
<br> 16. Any other clinically significant medical condition or laboratory abnormality that, in the opinion of the investigator, would jeopardize the safety of the patient or potentially impact patient compliance or the safety/efficacy observations in the study.
<br> |
-J128 Other viral pneumonia
<br>Other viral pneumonia;J128;Other viral pneumonia | <br> Group name: Antroquinonol Type of group;1 N° of participants:87 Intervention(s) description:Given orally at doses of 100 mg (1 capsule) BID for 14 days<br> Group name:Placebo Type of group;2 N° of participants:87 Intervention(s) description:Given orally at doses of 1 capsule BID for 14 days<br> | <br> Outcome name:The proportion of patients who are alive and free of respiratory failure (e.g., no need for invasive mechanical ventilation, non-invasive ventilation, high-flow oxygen, or ECMO)<br> Measure:Efficacy<br> Timepoints:Day 14<br> | | | | Yes | False | | |
| → | PER-093-20 | 12 October 2021→8 November 2021 | LOSVID STUDY | A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF LOSMAPIMOD IN ADULT SUBJECTS WITH COVID-19 | | Fulcrum Therapeutics INC., | 30/12/2020 | 20201230 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=093-20 | Not Recruiting | No | | | | 23/11/2020 | 60 | Interventional | This multicenter placebo-controlled study will evaluate the safety and efficacy of losmapimod versus placebo in hospitalized subjects ≥50 years old who have a C-reactive protein (CRP) >15 mg/L diagnosed with COVID-19 who can undergo randomization within 7 days of collection of the sample found positive for the SARS-CoV-2 virus and before progressing into critical disease. Subjects who sign informed consent and meet all entry criteria may be enrolled. Up to 410 subjects will participate for a maximum of 34 days, divided as follows: Screening: Day -3 until Day -1 before drug administration; Treatment period of 14 days; and Follow-up: 7 (± 3) and 14 (± 3) days after last dose. Randomization will be stratified (1:1) to either losmapimod tablets 15 mg orally twice daily or matching placebo tablets, by age, and requirement for oxygen (yes/no). The Sponsor will monitor individual adverse events (AEs) and toxicities on an ongoing basis throughout the study. All study visits during t | III | United States;Peru;Mexico;Colombia;Brazil;Argentina→Argentina;Brazil;Colombia;Mexico;Peru;United States | Yanina | Archenti | Av. Paseo de la Republica N° 6010 - Oficina # 401 | yarchenti@gotuzzos.com | 945194083 | GOTUZZO ASOCIADOS S.A.C. | Inclusion criteria:
<br> 1. Able and willing to provide written informed consent.
<br> 2. Willing and able to comply with all study procedures.
<br> 3. Age ≥50 years at time of screening.
<br> 4. Confirmed infection with SARS-CoV-2 virus at or before the baseline visit (by polymerase
<br> chain reaction [PCR] testing).
<br> 5. ≤7 days to the time of randomization from the time of collection of the specimen that tested
<br> positive for SARS-CoV-2 virus.
<br> 6. Hospitalization at the time of the baseline visit.
<br> 7. ≥90% oxygen saturation on room air and/or ≥94% oxygen saturation on oxygen
<br> administration at 2 L/min by nasal canula at the baseline visit.
<br> 8. Radiographic (X-ray or computed tomography scan, per local standard of care) evidence of
<br> pulmonary involvement consistent with COVID-19 at screening or baseline, per the judgment of the investigator.
<br> 9. Clinical syndrome consistent with COVID-19 at screening, per the judgment of the investigator
<br> 10. CRP at screening >15 mg/L (ie, >1.5 mg/dL) on local laboratory testing.
<br> 11. Agrees to practice an approved method of birth control as follows (as applicable to local guidelines and regulations for sites outside the United States)
<br> | Exclusion criteria:
<br> 1. Inability to take oral medication at screening or baseline visit.
<br> 2. Evidence at screening or baseline of critical COVID-19 disease
<br> 3. Positive pregnancy test at screening for women of childbearing potential.
<br> 4. Lactating female at baseline for women of childbearing potential.
<br> a. Note: a female will be considered eligible who is lactating at screening if she agrees to discontinue breastfeeding for the duration of the trial plus 14 days post last dose.
<br> 5. ≥5 × upper limit of normal (ULN) for alanine or aspartate aminotransferases or total bilirubin >1.5 × ULN at screening or known history of Child-Pugh Class C, hepatitis B or C, or HIV infection.
<br> 6. Glomerular filtration rate <30 mL/min/1.73 m2 at screening.
<br> 7. QTcF >450 msec for male or >470 msec for females or evidence of cardiac dysrhythmia at screening.
<br> 8. Significant history or evidence of clinically significant disorder, condition, current illness, illicit drug or other addiction, or disease that, in the opinion of the Investigator, would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.
<br> 9. Has been treated with immunomodulators or immunosuppressants including, but not limited to, interleukin (IL)-6 inhibitors, tumor necrosis factor (TNF) inhibitors, anti-IL-1 agents, and Janus kinase inhibitors, within 5 half-lives or 30 days, whichever is longer, prior to randomization, or plan to receive these agents any time during the study period.
<br> 10. Treatment with hydroxychloroquine/ chloroquine in the past 30 days or plan to receive these agents as part of investigational clinical trials or SOC any time during the study period.
<br> 11. Recent (within 30 days) or current participation in other COVID-19 therapeutic trials or expanded access programs.
<br> 12. Prior or current participation in COVID-19 vaccine trials.
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:LOSMAPIMOD Type of group;1 N° of participants:30 Intervention(s) description:15 mg losmapimod tablets orally twice daily<br> Group name:PLACEBO Type of group;2 N° of participants:30 Intervention(s) description:Placebo tablets twice dailly<br> | <br> Outcome name:A statistical analysis plan (SAP) will be generated and approved prior to database snapshot for the IA. The SAP will detail the implementation of all planned statistical analysis. Any deviations from the planned analysis will be described and justified in the final clinical study report.<br> In general, all study endpoints will be summarized using descriptive statistics. Descriptive statistics for continuous data will include number of subjects (n), mean, standard deviation, median, minimum, and maximum. Descriptive statistics for categorical data will include frequency and percentage.<br> For the final analysis, the proportion of subjects achieving the primary endpoint in the treatment arms will be compared using an adjusted risk difference obtained from a regression model, adjusted for stratification factors, sex, and baseline CRP. Full details of the regression model will be provided in the SAP. An interim analysis to assess futility analysis—and potential sample size re estimation—will be conducted. All results will be summarized descriptively by treatment arm and expressed as proportions, along with corresponding unadjusted/adjusted 95% CI of the difference between response rates, and p values.<br> Measure:Proportion of subjects who progress to death or respiratory failure by the end of study (Day 28)<br> Timepoints:06 months<br> | | | | No | False | | |
| → | PER-095-20 | 12 October 2021→8 November 2021 | A RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF MONOCLONAL ANTIBODY VIR-7831 FOR THE EARLY TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED PATIENTS | A RANDOMIZED, MULTI-CENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE SAFETY AND EFFICACY OF MONOCLONAL ANTIBODY VIR-7831 FOR THE EARLY TREATMENT OF CORONAVIRUS DISEASE 2019 (COVID-19) IN NON-HOSPITALIZED PATIENTS | | Vir Biotechnology, Inc., | 15/12/2020 | 20201215 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=095-20 | Not Recruiting | No | | | | 01/12/2020 | 50 | Interventional | <br> This study is a randomized, double-blind, multi-center, placebo-controlled trial of<br> VIR-7831, a monoclonal antibody (mAb) against SARS-CoV-2 for the prevention of<br> progression of mild/moderate COVID-19 in high risk adult participants, with interim<br> monitoring to allow early stopping for futility, efficacy, or safety. Participants with early,<br> mild/moderate COVID-19 who are at high risk for progression of disease will be<br> randomized 1:1 to receive a single, intravenous infusion of either VIR-7831 or equal<br> volume saline placebo. Comparisons of safety and efficacy will be based on data from<br> concurrently randomized participants.<br> Screening assessments will be performed within 24 hours before the first dose. Eligible<br> participants will be treated in a blinded manner with a single IV dose on Day 1 and<br> followed up to 24 weeks.<br> The Lead-In phase of this study will serve as the first-in-human assessment and will | II | Spain;Italy;United Kindgdom;Brazil;Canada;Chile;Peru;United States→United States;Peru;Chile;Canada;Brazil;United Kindgdom;Italy;Spain | Ximena | Siles Luna | Av. Mariscal Ramon Castilla Nº 685 | ximena.silesluna@syneoshealth.com | 7024477 | SYNEOS HEALTH PERU S.R.L. | Inclusion criteria:
<br> 1. Participant must be aged 18 years or older AND at high risk of progression of
<br> COVID-19 based on presence of one or more of the following risk factors:
<br> diabetes (requiring medication), obesity (BMI>30), chronic kidney disease
<br> (i.e., eGFR <60 by MDRD), congestive heart failure (NYHA class II or more),
<br> chronic obstructive pulmonary disease (history of chronic bronchitis, chronic
<br> obstructive lung disease, or emphysema with dyspnea on physical exertion), and
<br> moderate to severe asthma (participant requires an inhaled steroid to control
<br> symptoms or has been prescribed a course of oral steroids in the past year)
<br> OR
<br> 2. Participant ≥ 55 years old, irrespective of co-morbidities.
<br> 3. Participants who have a positive SARS-CoV-2 test result (by any validated test
<br> e.g. RT-PCR on any specimen type)
<br> AND
<br> Oxygen saturation ≥94% on room air
<br> AND
<br> Have COVID-19 defined by one or more of the following symptoms: fever, chills,
<br> cough, sore throat, malaise, headache, joint or muscle pain, change in smell or
<br> taste, vomiting, diarrhea, shortness of breath on exertion
<br> AND
<br> Less than or equal to 5 days from onset of symptoms.
<br> 4. No gender restrictions
<br> 5. Female participants must meet and agree to abide by the following contraceptive
<br> criteria. Contraception use by women should be consistent with local regulations
<br> regarding the methods of contraception for those participating in clinical studies.
<br> A female participant is eligible to participate if she is not pregnant or
<br> breastfeeding, and one of the following conditions applies:
<br> a. Is a woman of non-childbearing potential (WONCBP) as defined in
<br> Section 10.4.
<br> OR
<br> b. Is a WOCBP and using a contraceptive method that is highly effective, with a
<br> failure rate of <1%, as described in Section 10.4 of the protocol during the
<br> study intervention period and for up to 24 weeks after the last dose of study
<br> intervention. The investigator should evaluate potential for contraceptive
<br> method failure (e.g., noncompliance, recently initiated) in relationship to the
<br> first dose of study intervention.
<br> A WOCBP must have a negative highly sensitive pregnancy test (urine or serum
<br> as required by local regulations) before the first dose of study intervention.
<br> See Section 8.3.7 Pregnancy Testing of the protocol.
<br> − If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a
<br> serum pregnancy test is required. In such cases, the participant must be excluded
<br> from participation if the serum pregnancy result is positive.
<br> − Additional requirements for pregnancy testing during and after study intervention
<br> are located in Section 1.3 of the protocol.
<br> The investigator is responsible for review of medical history, menstrual history, and
<br> recent sexual activity to decrease the risk for inclusion of a woman with an early
<br> undetected pregnancy.
<br> 6. Capable of giving signed informed consent as described in Section 10.1 which
<br> includes compliance with the requirements and restrictions listed in the informed
<br> consent form (ICF) and in this protocol.
<br> OR
<br> If participants are not capable of giving written informed consent, alternative
<br> consent procedures will be followed as described in Section 10.1.3.
<br> | Exclusion criteria:
<br> 1. Currently hospitalized or judged by the investigator as likely to require
<br> hospitalization in the next 24 hours
<br> 2. Symptoms consistent with severe COVID-19 as defined by shortness of breath at
<br> rest or respiratory distress or requiring supplemental oxygen.
<br> 3. Participants who, in the judgement of the investigator are likely to die in the next
<br> 7 days.
<br> 4. Severely immunocompromised participants including but not limited to cancer
<br> patients receiving immunosuppressive chemotherapy or immunotherapy, those
<br> with a solid organ transplant or allogeneic stem cell transplant within the last
<br> 3 months, any history of heart or lung transplant or high dose long-term systemic corticosteroids (equivalent to ≥ 20mg a day of prednisone or the systemic equivalent for over 2 weeks)
<br> 5. Known hypersensitivity to any constituent present in the investigational product
<br> 6. Previous anaphylaxis or hypersensitivity to a monoclonal antibody.
<br> 7. Enrollment in any investigational vaccine study within the last 180 days or any
<br> other investigational drug study within 30 days prior to Day 1 or within
<br> 5 half-lives of the investigational compound, whichever is longer.
<br> 8. Enrollment in any trial of an investigational vaccine for SARS-CoV-2.
<br> 9. Receipt of any vaccine within 48 hours prior to enrollment. Vaccination will not
<br> be allowed for 4 weeks after dosing.
<br> 10. Receipt of convalescent plasma from a recovered COVID-19 patient or
<br> anti-SARS-CoV-2 mAb within the last 3 months.
<br> 11. Participants who, in the judgment of the investigator, will be unlikely or unable to
<br> comply with the requirements of the protocol through Day 29.
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:Experimental Type of group;1 N° of participants:670 Intervention(s) description:Monoclonal antibody (VIR-7831) against SARS-CoV2 administered intravenously by infusion for 1 hour, on the day of randomization (in a single dose). The follow up will be for 24 weeks.<br> Group name:Control Type of group;2 N° of participants:670 Intervention(s) description:Placebo to VIR-7831 (Sterile 0.9% (w/v) sodium chloride<br> solution) will be administered intravenously by infusion for 1 hour, on the day of randomization (in a single dose). The follow up will be for 24 weeks.<br> | <br> Outcome name:1. Hospitalization > 24 hours for acute<br> management of illness<br> OR<br> 2. Death<br> Measure:Proportion of participants who have<br> progression of COVID-19 through Day<br> 29 as defined by:<br> 1. Hospitalization > 24 hours for acute<br> management of illness<br> OR<br> 2. Death<br> Timepoints:Up to day 29<br> | | | | No | False | | |
| → | PER-099-20 | 12 October 2021→8 November 2021 | Fenofibrate research for the treatment of COVID-19. | FENOFIBRATE AS A METABOLIC INTERVENTION FOR CORONAVIRUS DISEASE 2019 (COVID-19): A RANDOMIZED CONTROLED TRIAL. | | UNIVERSIDAD CATOLICA DE SANTA MARIA, | 30/12/2020 | 20201230 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=099-20 | Recruiting | No | | | | 30/11/2020 | 150 | Interventional | Phase 3 trial, randomized, double-blind, international multicenter controlled parallel, prospective phenofibrate therapy (administered for 10 days) in patients with COVID-19. The design includes randomized administration of phenofibrate to 150 subjects and placebo to 150 other subjects, for 10 days, with daily data collection (inpatient patients), or at 5, 10, and 15 days post-randomization (outpatients), followed by 30-day post-randomization monitoring of all patients. Both groups will be assessed for vital status, readmissions and additional significant adverse effects | II | United States;Peru;Mexico;Colombia;Argentina→Argentina;Colombia;Mexico;Peru;United States | Jenny Marilu | Perez | Calle Rio Elba 160 | jenny_murpe@hotmail.com | 958 332 127 | UNIVERSIDAD CATOLICA DE SANTA MARIA | Inclusion criteria:
<br> 1. Age 18 years or older.
<br> 2. Diagnosis of COVID-19 (of any severity), based on: (a) A clinical presentation consistent with a positive laboratory test for SARS-CoV-2 (serological test or PCR); or (b) Considered by the family medical team as a person under investigation who is undergoing laboratory tests for COVID-19, with high clinical probability, in addition to compatible pulmonary infiltrates in radiographic plaque or chest tomography (bilateral, interstitial or ground glass opacities). Inclusion will require meeting criterion (2a) only, criterion (2b) only, or both. Patients who do not have a typical acute symptomatic picture of COVID-19 should not be included.
<br> 3. Ability to give informed consent.
<br> 4. Less than 14
<br> | Exclusion criteria:
<br> 1. Known pregnancy or lactation.
<br> 2. Estimated glomerular filtration rate (eGFR) 60 mL/min/1.73m2 or on dialysis (chronic renal disease stage 3-5).
<br> 3. History of active liver disease, cholelithiasis, hypothyroidism or rhabdomyolysis (suspected or confirmed). For purposes of the study, any history of chronic hepatopathy (including chronic hepatitis of any etiology, liver cirrhosis), recent history (last 12 months) of acute hepatitis of any etiology shall be considered as "active liver disease", or in the context of COVID-19, increase in circulating AST or ALT >3 times the upper normal limit (to be performed on all patients at trial cost, unless already available in the patient within the last 72 hours). Fatty liver without hepatitis, or a remote history (>12 months) of acute viral (e.g., hepatitis A) or medication-induced hepatitis that has not progressed to chronic liver disease, do not constitute an exclusion criterion for the study.
<br> 4. Known hypersensitivity to fenofibrate or fenofibric acid.
<br> 5. Current treatment with fenofibrate, clofibrate, warfarin or other coumarinic anticoagulants, glimepiride, cyclosporine, tacrolimus.
<br> 6. Use of statins, except simvastatin or atorvastatin. For these 2 statins, patients taking doses >40 mg/day will be excluded.
<br> 8. Inability to read, write, or lack of access to a phone.
<br> 9. Patients with endotracheal intubation.
<br> |
-B338 Other specified viral diseases
<br>Other specified viral diseases;B338;Other specified viral diseases | <br> Group name:Fenofibrate arm. Type of group;1 N° of participants:150 Intervention(s) description:The randomized intervention will be fenofibrate at a dose of 160 mg/d, administered for 10 days.<br> Group name:Placebo arm Type of group;2 N° of participants:150 Intervention(s) description:The intervention will be a placebo of appearance similar to the active drug<br> | <br> Outcome name:Blinded adjudication by the investigators based on systematic data collection regarding the clinical course of study participants.<br> Measure:Primary endpoint: global rank score that ranks patient outcomes according to 5 factors: (1) time to death (ranked from lower to higher, up to 30 days post-randomization), (2) the number of days in mechanical ventilatory support (invasive or non-invasive) or extracorporeal membrane oxygenation (up to discharge, evaluated up to 30 days post-randomization, ranked from highest to lowest); (3) The area under the curve in the ratio inspired oxygen fraction/oxygen saturation percentage (FiO2/SpO2, up to discharge, evaluated up to 30 days post-randomization, ranked from highest to lowest); (4) For participants enrolled as outpatients who are subsequently hospitalized, the number of days out of the hospital during the 30-day period following randomization (ranked from lowest to highest.<br> Timepoints:30 days.<br> | | | | No | False | | |
| → | PER-105-20 | 12 October 2021→8 November 2021 | A PHASE 2/3, RANDOMIZED, PARALLEL-GROUP, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CT-P59 IN COMBINATION WITH STANDARD OF CARE IN OUTPATIENTS WITH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS (SARS-COV-2) INFECTION | A PHASE 2/3, RANDOMIZED, PARALLEL-GROUP, PLACEBO-CONTROLLED, DOUBLE-BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CT-P59 IN COMBINATION WITH STANDARD OF CARE IN OUTPATIENTS WITH SEVERE ACUTE RESPIRATORY SYNDROME CORONAVIRUS (SARS-COV-2) INFECTION | | CELLTRION, INC., | 18/01/2021 | 20210118 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=105-20 | Recruiting | No | | | | 22/01/2021 | 120 | Interventional | <br> This is a phase 2/3, randomized, parallel-group, placebo-controlled, double-blind study with 2 parts to evaluate the efficacy, safety, PK and virology of CT-P59 in combination with SoC (except potential antiviral drugs and/or possible anti-SARS-CoV-2 activity drugs) in outpatients with mild to moderate symptoms of SARS-CoV-2 infection, not requiring supplemental oxygen therapy.<br><br> Approximately, a total of 1020 patients will be enrolled in this study. In Part 1, approximately 300 patients will be randomly assigned in a 1:1:1 ratio of CT-P59 80 mg/kg, 40 mg/kg or placebo. In Part 2, approximately 720 patients will be randomly assigned in a 1:1 ratio to CT-P59 80 mg/kg (or 40 mg/kg), or placebo. The actual dose of Part 2 will be determined based on the result from Part 1. Same study procedures will be conducted for both Part 1 and Part 2, unless otherwise specified.<br><br> The study will be unblinded to the predefined unblinded teams of sponsor and contract resea | III | Korea South;Spain;Hungary;United States;Peru;Mexico;Brazil;South Africa;Ukraine;Romania;Modalvia;Ireland→United States;Peru;Mexico;Brazil;South Africa;Ukraine;Romania;Modalvia;Ireland;Hungary;Spain;Korea South | Elena | Camacho | Av. Republica de Panama 3461, Interior 1801 Urb. El palomar | Elena.CamachoRuiz@ppdi.com | 614-4100 | PPD Peru S.A.C. | Inclusion criteria: 1. Adult male or female patient, aged 18 or above. 2. Patient diagnosed with SARS-CoV-2 infection at Screening by using the sponsor-supplied rapid SARS-CoV-2 diagnostic test or RT-PCR. Note: If the patient had a RT-PCR result (within 72 hours prior to the study drug administration) confirming SARS-CoV-2 infection even if before signing the ICF, the patient can be enrolled without additional confirmation of SARS-CoV-2 infection at Screening. Note: During the Screening Period, only one re-test for confirmation of SARS-CoV-2 infection will be allowed, if study drug can be administered no more than 7 days from onset of symptom based on the re-test result. 3. Patient with conditions meeting all of the following criteria: a. Oxygen saturation >94% on room air. b. Not requiring supplemental oxygen. Note: Patient with clinical signs of pneumonia but no signs of severe pneumonia (as defined in the World Health Organization Guidance, 2020) at the investigator’s discretion is eligible for this study. 4. Patient whose onset of symptom is no more than 7 days prior to the study drug administration. Onset time of symptom is defined as the time when the patient experienced the presence of at least one SARS-CoV-2 infection associated symptom. 5. Patient who has one or more of the following (but not limited to) SARS-CoV-2 infection associated symptoms within but not more than 7 days prior to the study drug administration: a. Feeling feverish b. Cough c. Shortness of breath or difficulty breathing d. Sore throat e. Body pain or muscle pain f. Fatigue g. Headache h. Chills i. Nasal obstruction or congestion j. Loss of taste or smell k. Nausea or vomiting l. Diarrhea 6. Patient who has one or more of the following SARS-CoV-2 infection associated symptoms present within 48 hours prior to the study drug administration: a. Feeling feverish b. Cough c. Shortness of breath or difficulty breathing d. Sore throat e. Body pain or muscle pain f. Fatigue g. Headache 7. Patient (or legal guardian, if applicable) who is informed and given ample time and opportunity to read and/or understand the nature and purpose of this study including possible risks and side effects and must sign the informed consent form prior to participation in the study. 8. For both male and female patients, the patient and his or her partner of childbearing potential who agree to use a highly effective or medically acceptable methods of contraception during the course of the study and for 6 months following discontinuation of study drug as specified below: • Combined (estrogen and progestogen containing) or progestogen-only hormonal contraception associated with inhibition of ovulation • Intrauterine devices • True abstinence, when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods), declaration of abstinence of the duration of exposure to investigational drug, and withdrawal are not acceptable methods of contraception. • Condom in addition to use spermicide, hormonal contraceptive or barrier method in female; for male patient with his female partner of childbearing potential only. Spermicide condom (condoms coated with spermicide) use alone is not allowed. Male and female patients and their partners who have been surgically sterilized for less than 6 months prior to the date of informed consent must agree to use any highly effective or medically acceptable methods of contraception. Meno | Exclusion criteria:
<br> 1. Patient with current serious condition meeting one of the following criteria:
<br> a. Previously or currently hospitalized or requires hospitalization for treatment of serious SARS-CoV-2 related conditions (severe disease as defined in the World Health Organization Guidance, 2020).
<br> b. Respiratory distress with respiratory rate ≥30 breaths/min.
<br> c. Requires supplemental oxygen.
<br> d. Experience shock.
<br> e. Complicated with other organs failure, and intensive care unit monitoring treatment is needed by investigator’s discretion.
<br> 2. Patient who has received or has a plan to receive any of following prohibited medications or treatments:
<br> a. Drugs with actual or possible antiviral drugs and/or possible anti-SARS-CoV-2 activity including but not limited to remdesivir, chloroquine, hydroxychloroquine, dexamethasone (alternative corticosteroids to dexamethasone), interferon beta-1b, ribavirin, and other immunomodulatory agents and human immunodeficiency virus protease inhibitors (lopinavir-ritonavir, etc.) for therapeutic purpose of SARS-CoV-2 infection prior to study drug administration.
<br> b. Any SARS-CoV-2 human intravenous immunoglobulin, convalescent plasma for the treatment of SARS-CoV-2 infection prior to study drug administration.
<br> c. Any other investigational device or medical product including but not limited to any monoclonal antibody (tocilizumab, sarilumab, etc.), fusion proteins or biologics for the treatment of SARS-CoV-2 infection prior to the study drug administration.
<br> d. Use of medications that are contraindicated with SoC.
<br> e. SARS-CoV-2 vaccine prior to the study drug administration.
<br> Note: During the study, in the event of progression of SARS-CoV-2 infection, rescue therapies using the prohibited medications are allowed based on the patient’s clinical disease status. Where treatments become SoC for the populations outlined in this study, the new SoC treatment will be added on to all of the treatment groups during the study. For SoC with a similar mechanism of action as the investigational agent (CT-P59), modifications to study design may be considered for Part 2 of this study.
<br> 3. Patient who has known allergy or hypersensitivity reaction to any monoclonal antibody or to any components of study drug.
<br> 4. Patient who has a current or history of any of the following infections:
<br> a. Any active infection other than SARS-CoV-2 requiring systemic treatment.
<br> b. Severe infection, in the investigator’s opinion, within 30 days prior to the administration of study drug that required parenteral antibiotic use or hospitalization.
<br> 5. Patient who has a medical condition including one or more of the following at Screening:
<br> a. Any uncontrolled clinically significant respiratory disease in the investigator’s opinion (e.g., chronic obstructive pulmonary disease, cystic fibrosis, bronchiectasis, asthma).
<br> b. Abnormal liver function values including but not limited to the aspartate transaminase, alanine transaminase or alkaline phosphatase ≥5 × upper limit normal.
<br> c. Renal impairment (estimated glomerular filtration rate <30 mL/min/1.73m2) or receiving continuous renal replacement therapy, hemodialysis, peritoneal dialysis.
<br> d. History or presence of congestive heart failure with symptoms consistent with New York Heart Association Class III or IV functional status within 6 months prior to the study drug administration.
<br> e. Presence of clin |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:1 Type of group;1 N° of participants:360 Intervention(s) description:CT-P59 80 mg/kg (OR 40 mg/kg) by single IV infusion over 90 minutes (±15 minutes) with SoC (standard of care)<br> Group name:2 Type of group;2 N° of participants:360 Intervention(s) description:Placebo matching in volume of CT-P59 80 mg/kg (OR 40 mg/kg) by single IV infusion over 90 minutes (±15 minutes) with SoC (standard of care)<br> | <br> Outcome name:Checklist and direct evaluation of the patient with or without laboratory tests.<br> Measure:Efficacy Assessments:<br> Proportion of patients with clinical symptom requiring hospitalization, oxygen therapy, or experiencing mortality due to SARS-CoV-2 infection up to Day 28<br><br> Timepoints:Up to Day 28<br> | | 20/04/2021 | | Yes | False | | |
| → | PER-106-20 | 12 October 2021→8 November 2021 | HERALD | COVID-19: A PHASE 2B/3, RANDOMIZED, OBSERVER-BLINDED, PLACEBO-CONTROLLED, MULTICENTER CLINICAL STUDY EVALUATING THE EFFICACY AND SAFETY OF INVESTIGATIONAL SARS-COV-2 MRNA VACCINE CVNCOV IN ADULTS 18 YEARS OF AGE AND OLDER | | CureVac AG, | 29/12/2020 | 20201229 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=106-20 | Recruiting | No | | | | 30/12/2020 | 10720 | Interventional | Trial CV-NCOV-004 will be conducted in 2 parts: an initial Phase 2b trial followed by transition to a large Phase 3 efficacy trial. Both Phase 2b and Phase 3 will be conducted as randomized, observer-blinded, placebo-controlled trials. Subjects 18 years of age or older will be enrolled at multiple sites globally and will receive a 2-dose schedule of either CVnCoV at a dose level of 12 μg mRNA or placebo {normal saline (0.9% NaCl)} in a 1:1 ratio. Both Phase 2b and Phase 3 parts of the trial are consistent in design (e.g., for COVID-19 case ascertainment and case definition) so that cases of COVID-19 occurring in Phase 2b can be pooled with those in Phase 3 for the primary analysis of VE. Subjects will also participate in a 1-year extension of the Phase 2b and Phase 3 parts of the trial. More information, please check the protocol | III | Germany;Belgium;Spain;Nederland;Argentina;Colombia;Dominican Republic;Mexico;Peru | Elizabeth | Rospigliosi | Via Central 125, Edificio Real Ocho Piso 16, Urbanizacion Empresarial Real | rospigliosielizabeth@prahs.com | 941490447 | RPS PERU S.A.C | Inclusion criteria:
<br> 1. Male or female subjects 18 years of age or older.
<br> 2. Provide written informed consent prior to initiation of any trial
<br> procedures.
<br> 3. Expected compliance with protocol procedures and availability for
<br> clinical follow-up through the last planned visit.
<br> 4. Females of non-childbearing potential defined as follows: surgically
<br> sterile (history of bilateral tubal ligation, bilateral oophorectomy or
<br> hysterectomy) or postmenopausal {defined as amenorrhea for
<br> ≥ 12 consecutive months prior to screening (Day 1)} without an
<br> alternative medical cause). A follicle-stimulating hormone (FSH)
<br> level may be measured at the discretion of the Investigator to confirm
<br> postmenopausal status.
<br> 5. Females of childbearing potential: negative urine pregnancy test
<br> {human chorionic gonadotropin (hCG)} within 24 hours prior to each
<br> trial vaccination on Day 1 and Day 29.
<br> 6. Females of childbearing potential must use highly effective methods
<br> of birth control from 2 weeks before the first administration of the trial
<br> vaccine until 3 months following the last administration. The following
<br> methods of birth control are considered highly effective when used
<br> consistently and correctly:
<br> · Combined (estrogen and progestogen containing) hormonal
<br> contraception associated with inhibition of ovulation (oral,
<br> intravaginal or transdermal);
<br> · Progestogen-only hormonal contraception associated with
<br> inhibition of ovulation (oral, injectable or implantable);
<br> · Intrauterine devices (IUDs);
<br> · Intrauterine hormone-releasing systems (IUSs);
<br> · Bilateral tubal occlusion;
<br> · Vasectomized or infertile partner;
<br> · Sexual abstinence {periodic abstinence (e.g., calendar, ovulation,
<br> symptothermal and post-ovulation methods) and withdrawal are
<br> not acceptable}.
<br> | Exclusion criteria:
<br> 1. History of virologically-confirmed COVID-19 illness.
<br> 2. For females: pregnancy or lactation.
<br> 3. Use of any investigational or non-registered product (vaccine or
<br> drug) within 28 days preceding the administration of the first trial
<br> vaccine or planned use during the trial.
<br> 4. Receipt of licensed vaccines within 28 days (for live vaccines) or
<br> 14 days (for inactivated vaccines) prior to the administration of the
<br> first trial vaccine. 5. Prior administration of any investigational SARS-CoV-2 vaccine or
<br> another coronavirus (SARS-CoV, MERS-CoV) vaccine or planned
<br> use during the trial.
<br> 6. Any treatment with immunosuppressants or other immune-modifying
<br> drugs (including but not limited to corticosteroids, biologicals and
<br> methotrexate) for > 14 days total within 6 months preceding the
<br> administration of trial vaccine or planned use during the trial. For
<br> corticosteroid use, this means prednisone or equivalent, 0.5
<br> mg/kg/day for 14 days or more. The use of inhaled, topical, or
<br> localized injections of corticosteroids (e.g., for joint
<br> pain/inflammation) is permitted.
<br> 7. Any medically diagnosed or suspected immunosuppressive or
<br> immunodeficient condition based on medical history and physical
<br> examination including known infection with human
<br> immunodeficiency virus (HIV), hepatitis B virus (HBV) or hepatitis C
<br> virus (HCV); current diagnosis of or treatment for cancer including
<br> leukemia, lymphoma, Hodgkin disease, multiple myeloma, or
<br> generalized malignancy; chronic renal failure or nephrotic syndrome;
<br> and receipt of an organ or bone marrow transplant.
<br> 8. History of angioedema (hereditary or idiopathic), or history of any
<br> anaphylactic reaction and pIMD.
<br> 9. History of allergy to any component of CVnCoV vaccine.
<br> 10. Administration of immunoglobulins or any blood products within
<br> 3 months prior to the administration of trial vaccine or planned receipt
<br> during the trial.
<br> 11. Subjects with a significant acute or chronic medical or psychiatric
<br> illness that, in the opinion of the Investigator, precludes trial
<br> participation (e.g., may increase the risk of trial participation, render
<br> the subject unable to meet the requirements of the trial, or may
<br> interfere with the subject’s trial evaluations). These include severe
<br> and/or uncontrolled cardiovascular disease, gastrointestinal disease,
<br> liver disease, renal disease, respiratory disease, endocrine disorder,
<br> and neurological and psychiatric illnesses. However, those with
<br> controlled and stable cases can be included in the trial.
<br> 12. Subjects with impaired coagulation or any bleeding disorder in whom
<br> an intramuscular injection or a blood draw is contraindicated.
<br> 13. Foreseeable non-compliance with the trial procedures as judged by
<br> the Investigator.
<br> |
-B342 Coronavirus infection, unspecified site
<br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | <br> Group name:Arm 1 Type of group;1 N° of participants:2000 (Fase 2b) Intervention(s) description:The objective of Phase 2b is to further characterize the safety, reactogenicity, and immunogenicity of CVnCoV prior to initiating Phase 3. CVnCoV will be administered at the 12 µg dose level selected for Phase 3 investigation informed by the safety and immunogenicity data from the initial Phase 1 and 2a trials. Phase 2b will be conducted in 2 age groups of adults: 18 to 60 and ≥ 61 years of age, which represent the age range of the intended Phase 3 trial population.<br> Approximately 4,000 subjects will be enrolled and randomized in a 1:1 ratio to receive 2 doses of either CVnCoV or placebo, administered 28 days apart (see Synopsis Figure 1). Of the 4,000 subjects enrolled, approximately 800 to 1,000 (20% to 25%) will be ≥ 61 years of age.<br> Subject Follow up Time: Days 1 and 29<br><br> Group name:Arm 2 Type of group;2 N° of participants:16250 (Fase 3) Intervention(s) description: This group in the corresponding control of the experimental mentioned above, for participants of phase 3. The control treatment consist of the same volume of 0.9% saline, administered on days 1 and 29. 2 doses, on days 1 and 29.<br> | <br> Outcome name:In primary efficacy analysis, the VE, defined as the percent reduction in the frequency of any and moderate to severe COVID-19 cases (according to primary case definitions) in vaccinated subjects compared with subjects who received placebo will be calculated with exact 95%* CI as follows:<br> VE = 1- RR = 1 - (ARV/ARP) = 1 - {p / r (1-p)}<br> where<br> ARV = attack rate in vaccinated group = nv/Nv = number of subjects reporting at least one COVID-19 episode in the CVnCoV group / total follow-up time of evaluable subjects in the CVnCoV group (number of person-month).<br> ARP = attack rate in placebo group = np/Np = number of subjects reporting at least one COVID-19 episode in the placebo group / total follow-up time of evaluable subjects in the placebo group (number of person-month).<br> RR = relative risk = ARV/ARP<br> p = proportion of COVID-19 cases (according to primary case definition) coming from the CVnCoV group among all cases = nv/(nv+np).<br> r = ratio of total follow-up time of evaluable subjects in the CVnCoV group over total follow-up time of evaluable subjects in the placebo group = Nv/Np.<br> *Level of CI may be slightly adjusted due to the sequential design<br> Measure:Co-Primary Efficacy Endpoints<br> · Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of COVID-19 of any severity meeting the case definition for the primary efficacy analysis.<br> · Occurrence of first episodes of virologically-confirmed (RT-PCR positive) cases of moderate to severe COVID-19 meeting the case definition for the primary efficacy analysis (moderate and severe COVID-19 disease is defined in Appendix 3 and Appendix 4).<br> Primary Safety Endpoints<br> · Occurrence, intensity and relationship of medically-attended AEs collected through 6 months after the second trial vaccination in all subjects.<br> · Occurrence, intensity and relationship of SAEs and AESIs collected through 1 year after the second trial vaccination in all subjects. · Occurrence of fatal SAEs through 1 year after the second trial<br> vaccination in all subjects.<br> Timepoints:6 months<br> | | | | Yes | False | | |
| → | PER-108-20 | 12 October 2021→8 November 2021 | OPAGANIB, A SPHINGOSINE KINASE-2 (SK-2) INHIBITOR IN COVID-19 PNEUMONIA: A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN HOSPITALIZED ADULT SUBJECTS WITH SEVERE SARS-COV-PNEUMONIA- 2 POSITIVE | OPAGANIB, A SPHINGOSINE KINASE-2 (SK-2) INHIBITOR IN COVID-19 PNEUMONIA: A PHASE 2/3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY IN HOSPITALIZED ADULT SUBJECTS WITH SEVERE SARS-COV-PNEUMONIA- 2 POSITIVE | | RedHill Biopharma Ltd., | 23/03/2021 | 20210323 | REPEC | https://www.ins.gob.pe/ensayosclinicos/rpec/recuperarECPBNuevoEN.asp?numec=108-20 | Not Recruiting | No | | | | 01/01/2021 | 55 | Interventional | <br> This is a phase 2/3, multicenter, randomized, double-blind, parallel-group, placebo-controlled study with an adaptive design that will use an assessment of futility. The study is scheduled to take place worldwide at approximately 60 clinical centers.<br> After obtaining informed consent, patients will enter a screening phase for no more than 3 days, to determine eligibility. Approximately 270 eligible patients will be randomized to receive opaganib added to standard of care, or an equivalent placebo added to standard of care, in a 1: 1 randomization ratio. Treatment assignments will remain blinded to patient, investigator, and staff the hospital as well as the sponsor. Study participants will receive opaganib 2 x 250 mg capsules (500 mg) every 12 hours, or a placebo equivalent, in addition to standard care (pharmacological as defined above and / or supportive) at any institution. The study drug will be administered every day for 14 days (from day 1 to day 14). All parti | II | Israel;Russian Federation;Brazil;Mexico;Peru | Raul Florentino Hernan | Yepez | Avnida Circunvalacion Golf Los Incas Nro. 206, Torre II Oficina 801, | r.yepez@pcr.pe | 999962145 | PERUVIAN CLINICAL RESEARCH S.A.C | Inclusion criteria:
<br> 1. Adult men or women ≥18 to ≤80 years
<br> 2. Infection proven by COVID-19 by RT-PCR assay of a pharyngeal specimen (nasopharyngeal or oropharyngeal) AND pneumonia defined as radiographic opacities on chest x-ray or CT that diagnosed COVID-19 pneumonia. Pharyngeal specimens collected at screening or within 7 days prior to screening are acceptable for the same ongoing COVID-19 pneumonia disease.
<br> 3. Patient requires, at baseline, supplemental high-flow oxygen or positive pressure ventilation, if high-flow oxygen is not an available option.
<br> 4. Male participants with female partners of childbearing potential accept one of the following appropriate contraceptive methods during the treatment period and for at least 1 month after the last dose of study drug:
<br> Abstinence from penile-vaginal intercourse and agreeing to remain abstinent.
<br> • Male condom, with the female partner using a highly effective contraceptive method. (For more details on highly effective contraceptive methods, see Section 11.3).
<br> Additionally, male participants must refrain from donating sperm during the study and for 1 month after the last dose of study drug.
<br> Male participants with a pregnant or lactating partner must agree to abstain from penile-vaginal intercourse or use a male condom during each episode of penile penetration for at least 1 month after the last dose of the penile drug. study.
<br> Female participants:
<br> A participant is eligible to participate if:
<br> a) is not pregnant
<br> b) not breastfeeding
<br> c) is not a woman of childbearing age (WOCBP, as defined in Section 11.3)
<br> d) is a WOCBP who agrees to consistently and correctly use a highly effective method of contraception during the treatment period and for at least 1 month after the last dose of study drug (see Section 11.3 for details).
<br> 5. The patient or legal representative has signed a written informed consent approved by the Ethics Committee / IRB
<br> | Exclusion criteria:
<br> 1. Any comorbidity that may add risk to the treatment in the judgment of the investigator
<br> 2. Require intubation and mechanical ventilation in the baseline period
<br> 3. Patient has a "Do not intubate" and / or "Do not resuscitate" order present.
<br> 4. Oxygen saturation> 95% in ambient air
<br> 5. Any pre-existing respiratory condition requiring intermittent or continuous ambulatory oxygen prior to hospitalization.
<br> 6. If it is unlikely, based on the investigator´s clinical judgment, that the patient will survive> 72 hours
<br> 7. Pregnant women (positive urine or serum test within 3 days prior to randomization) or lactating women
<br> 8. Lack of will or inability to comply with the procedures required in this protocol
<br> 9. Corrected QT interval (QTc) on the electrocardiogram (ECG)> 470 ms for women or> 450 ms for men, calculated using Friedericia´s formula (QTcF)
<br> 10. AST (SGOT) or ALT (SGPT)> 5.0 x upper limit of normal (ULN)
<br> 11. Total bilirubin> 2.0 x ULN (except where increased bilirubin is due to Gilbert Syndrome)
<br> 12. Serum creatinine> 2.0 X ULN
<br> 13. Absolute neutrophil count <1000 cells / mm3
<br> |
-J128 Other viral pneumonia
<br>Other viral pneumonia;J128;Other viral pneumonia | <br> Group name:GROUP 1 Type of group;1 N° of participants:232 Intervention(s) description:Opaganib 500 mg Every 12 hours as a suspension, can be administered by nasogastric tube.<br> Group name:group 2 Type of group;2 N° of participants:232 Intervention(s) description:placebo (opaganid) 500 mg Every 12 hours as a suspension, can be administered by nasogastric tube.<br> | <br> Outcome name:Clinical/laboratory<br> Measure:the proportion of patients requiring intubation and mechanical ventilation<br> Timepoints:by Day 14<br> | | | | No | False | | |
| → | PER-002-21 | 12 October 2021→8 November 2021 | A Multicenter, Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial to Evaluate the Efficacy and Safety of Monoclonal Antibody SCTA01 against SARS-CoV-2 in Hospitalized Patients with Severe COVID-19 | A Multicenter, Adaptive, Randomized, Double-blinded, Placebo-controlled Phase II/III Trial to Evaluate the Efficacy and Safety of Monoclonal Antibody SCTA01 against SARS-CoV-2 in Hospitalized Patients with Severe COVID-19 | | Sinocelltech, Ltd. | | 0 | REPEC | https://repec.ins.gob.pe/maestro/ajax/exportar-ficha-datos-publico/5/en/ | | No | | | Both | 26/03/2021 | 795 | Interventional | | 2 | United States;Mexico;Colombia;Chile;Brazil;Argentina | Flor de Liz;Lis Roxana | Jacome;Bueno | Calle Monte Rosa Nº 255 Piso 4-Chacarilla del Estanque;Calle Monte Rosa Nº 255 Piso 4-Chacarilla del Estanque | liz.jacome@covance.com;lis.bueno@covance.com | 987507623;924082167 | COVANCE PERU SERVICES S.A.;COVANCE PERU SERVICES S.A. | Inclusion criteria:
<br> • Hospitalized patients with severe COVID-19 (5 point on the 8-point ordinal scale). According to the NIH definition, severe patients are those individuals who have one of the following: 1) respiratory rate > 30 breaths per minute 2) SpO2 = 93% on room air at sea level; 3) PaO2/FiO2 <300 mmHg or SpO2/FiO2= 315 mmHg; 4) lung infiltrates > 50%. In high altitude area (over 1000 meters), PaO2/FiO2 should be corrected according to the following formula: PaO2/FiO2 × [barometric pressure (mmHg/760)]; 5 point: Hospitalized, requiring supplemental oxygen; • Male or female adult =18 years of age at time of enrollment; • Biological samples (not limited to any specific type) collected within 72 hours before randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR or antigen-based diagnostic tests); • = 10 days since symptoms of COVID-19 onset.→Inclusion criteria:
<br> • Hospitalized patients with severe COVID-19 (5 point on the 8-point ordinal scale). According to the NIH definition, severe patients are those individuals who have one of the following: 1) respiratory rate > 30 breaths per minute 2) SpO2 = 93% on room air at sea level; 3) PaO2/FiO2 < 300 mmHg or SpO2/FiO2= 315 mmHg; 4) lung infiltrates > 50%. In high altitude area (over 1000 meters), PaO2/FiO2 should be corrected according to the following formula: PaO2/FiO2 × [barometric pressure (mmHg/760)]; 5 point: Hospitalized, requiring supplemental oxygen; • Male or female adult =18 years of age at time of enrollment; • Biological samples (not limited to any specific type) collected within 72 hours before randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR or antigen-based diagnostic tests); • = 10 days since symptoms of COVID-19 onset.
<br> | Exclusion criteria:
<br> • Hospitalized patients with severe COVID-19 (5 point on the 8-point ordinal scale). According to the NIH definition, severe patients are those individuals who have one of the following: 1) respiratory rate > 30 breaths per minute 2) SpO2 = 93% on room air at sea level; 3) PaO2/FiO2 <300 mmHg or SpO2/FiO2= 315 mmHg; 4) lung infiltrates > 50%. In high altitude area (over 1000 meters), PaO2/FiO2 should be corrected according to the following formula: PaO2/FiO2 × [barometric pressure (mmHg/760)]; 5 point: Hospitalized, requiring supplemental oxygen; • Male or female adult =18 years of age at time of enrollment; • Biological samples (not limited to any specific type) collected within 72 hours before randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR or antigen-based diagnostic tests); • = 10 days since symptoms of COVID-19 onset.␣
<br> ␣• Patients who need non-invasive ventilation or high flow oxygen (i.e., 6 point on the 8-point ordinal scale); • Patients with critical COVID-19. According to the NIH definition, critical patients are those individuals who have one of the following conditions: 1) respiratory failure and need invasive mechanical ventilation; 2) septic shock; 3) multiple organ dysfunction; • Patients with severe COVID-19 who received convalescent plasma or anti-SARS-CoV-2 spike (S) protein targeted therapy; • Alanine-amino transferase (ALT) or aspartate transaminase (AST) is 5 times higher than the upper limit of the normal value; • Estimated glomerular filtration rate (eGFR) <30 mL/min or on dialysis {eGFR calculated by Cockcroft-Gault formula (Cockcroft DW, 1976), Male: CrCL (mL/min) = [(140 - age) × weight (kg)] × 1/ [SCr (mg/dL) × 72]; Female: CrCL (mL/min) = [(140 -age) × weight (kg)] × 0.85/ [SCr (mg/dL) × 72]}.→Exclusion criteria:
<br> • Hospitalized patients with severe COVID-19 (5 point on the 8-point ordinal scale). According to the NIH definition, severe patients are those individuals who have one of the following: 1) respiratory rate > 30 breaths per minute 2) SpO2 = 93% on room air at sea level; 3) PaO2/FiO2 < 300 mmHg or SpO2/FiO2= 315 mmHg; 4) lung infiltrates > 50%. In high altitude area (over 1000 meters), PaO2/FiO2 should be corrected according to the following formula: PaO2/FiO2 × [barometric pressure (mmHg/760)]; 5 point: Hospitalized, requiring supplemental oxygen; • Male or female adult =18 years of age at time of enrollment; • Biological samples (not limited to any specific type) collected within 72 hours before randomization is laboratory-confirmed as SARS-CoV-2 infection (PCR or antigen-based diagnostic tests); • = 10 days since symptoms of COVID-19 onset.
<br> • Patients who need non-invasive ventilation or high flow oxygen (i.e., 6 point on the 8-point ordinal scale); • Patients with critical COVID-19. According to the NIH definition, critical patients are those individuals who have one of the following conditions: 1) respiratory failure and need invasive mechanical ventilation; 2) septic shock; 3) multiple organ dysfunction; • Patients with severe COVID-19 who received convalescent plasma or anti-SARS-CoV-2 spike (S) protein targeted therapy; • Alanine-amino transferase (ALT) or aspartate transaminase (AST) is 5 times higher than the upper limit of the normal value; • Estimated glomerular filtration rate (eGFR) <30 mL/min or on dialysis {eGFR calculated by Cockcroft-Gault formula (Cockcroft DW, 1976), Male: CrCL (mL/min) = [(140 - age) × weight (kg)] × 1/ [SCr (mg/dL) × 72]; Female: CrCL (mL/min) = [(140 -age) × weight (kg)] × 0.85/ [SCr (mg/dL) × 72]}. | B342 INFECCION DEBIDA A CORONAVIRUS, SIN OTRA ESPECIFICACION <br>Coronavirus infection, unspecified site;B342;Coronavirus infection, unspecified site | Phase II = 285 Subjects Phase III= 255 Subjects SCTA01 will be provided as a sterile, liquid solution. Each glass vial contains 10 mL of study medication with a concentration of 25 mg/mL Each 10 mL vial contains Recombinant anti-SARS-CoV-2 spike monoclonal antibody for injection (Placebo) 1 single injection at time of enrolment - Phase II = 285 Subjects 15 mg/kg group 50 mg/kg Phase III = 255 Subjects The best dose of Phase II SCTA01 will be provided as a sterile, liquid solution. Each glass vial contains 10 mL of study medication with a concentration of 25 mg/mL Each 10 mL vial contains Recombinant anti-SARS-CoV-2 spike monoclonal antibody with a concentration of 25 mg/mL 1 single injection at time of enrolment | 8-point ordinal scale NAME OF THE RESULT: Time to clinical improvement (TTCI) up to Day 29. TTCI is defined as the time (in days) from randomization to the first day on which a patient satisfies point 1, 2, or 3 on the 8-point ordinal scale and maintains a score = 3 at least 48 hours (initial improvement) and maintains this up to Day 29 (sustained improvement) (Phase II, III). PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: Maintains a score = 3 at least 48 hours (initial improvement) and maintains this up to Day 29 (sustained improvement) (Phase II, III). | | | | Yes | False | | |
| → | PER-008-21 | 12 October 2021→8 November 2021 | A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults | A Phase III Randomized, Double-blind, Placebo-controlled, Multicenter Study to Determine the Safety and Efficacy of AZD7442 for the Treatment of COVID-19 in Non-hospitalized Adults | | AstraZeneca AB | | 0 | REPEC | https://repec.ins.gob.pe/maestro/ajax/exportar-ficha-datos-publico/1945/en/ | | No | | | Both | 28/01/2021 | 1700 | Interventional | | 3 | Czech Republic;Mexico;Peru;United States;Japan;Germany;Spain;Hungary;Italy;Poland;United Kindgdom;Russian Federation | MARIA DEL CARMEN;KELLY | MOYA;VASQUEZ | Calle LAs orquidras 675 of 802;Calle LAs orquidras 675 of 802 | mariadelcarmen.moya@astrazeneca.com;kelly.vasquez@astrazeneca.com | 987714838;6101515 | ASTRAZENECA PERU S.A.;ASTRAZENECA PERU S.A. | Inclusion criteria:
<br> Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: Age 1 Participant must be = 18 years of age inclusive at the time of signing the informed consent.
<br> Age 1 Participant must be = 18 years of age inclusive at the time of signing the informed consent.
<br> Type of Participant and Disease Characteristics 2 Participant who has a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (eg, oropharyngeal, NP, or nasal swab, or saliva) collected = 3 days prior to Day 1.
<br>
<br> 3 WHO Clinical Progression Scale score > 0 and <4
<br> 4 Participant must be dosed with IMP no more than 7 days from self-reported onset of COVID-19-related symptoms (mild to moderate COVID) or measured fever, defined as the self-reported date of first reported sign/symptom from the following list: ? Subjective fever or feeling feverish ? Cough ? Shortness of breath or difficulty breathing at rest or with activity ? Sore throat ? Body pain or muscle pain/aches ? Fatigue ? Headache ? Chills ? Nasal obstruction or congestion ? Nasal discharge ? New loss of taste or smell ? Nausea or vomiting ? Diarrhea ? Documented temperature > 37.8° C ? New onset confusion (only for participants = 60 years old) ? Appetite loss or decreased food intake (only for participants = 60 years old) ? Increased supplemental oxygen requirement (only for participants on baseline supplemental oxygen)
<br> 5 One or more of the following signs/symptoms must be present within 24 hours prior to Day 1: ? Cough ? Sore throat ? Shortness of breath or difficulty breathing at rest or with activity ? Body pain or muscle pain/aches ? Fatigue ? Headache ? Chills ? Nasal obstruction or congestion ? Nasal discharge ? Nausea or vomiting ? Diarrhea ? New loss of taste or smell
<br> 6 Oxygenation saturation of = 92% obtained at rest by study staff within 24 hours prior to Day 1, unless the potential participant regularly receives chronic supplementary oxygen for an underlying lung condition.
<br> Participation in another COVID-19 treatment trial 7 Agrees not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days post-entry, whichever is earliest.
<br>
<br> Reproduction 8 Contraceptive use by men or women. (a) Male participants: Contraception for male participants is not required; however, to avoid the transfer of any fluids, all male participants must use a condom from Day 1 and agree to continue through 365 days following administration of IMP. (b) Female participants: ??Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply: o Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle-stimulating hormone levels in the postmenopausal range. o Women = 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal trea→Inclusion criteria: Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: Age 1 Participant must be = 18 years of age inclusive at the time of signing the informed consent.
<br> Age
<br> 1 Participant must be = 18 years of age inclusive at the time of signing the informed consent. Type of Participant and Disease Characteristics
<br> 2 Participant who has a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (eg, oropharyngeal, NP, or nasal swab, or saliva) collected = 3 days prior to Day 1.
<br> 3 WHO Clinical Progression Scale score > 0 and < 4
<br> 4 Participant must be dosed with IMP no more than 7 days from self-reported onset of COVID-19-related symptoms (mild to moderate COVID) or measured fever, defined as the self-reported date of first reported sign/symptom from the following list: ? Subjective fever or feeling feverish ? Cough ? Shortness of breath or difficulty breathing at rest or with activity ? Sore throat ? Body pain or muscle pain/aches ? Fatigue ? Headache ? Chills ? Nasal obstruction or congestion ? Nasal discharge ? New loss of taste or smell ? Nausea or vomiting ? Diarrhea ? Documented temperature > 37.8° C ? New onset confusion (only for participants = 60 years old) ? Appetite loss or decreased food intake (only for participants = 60 years old) ? Increased supplemental oxygen requirement (only for participants on baseline supplemental oxygen)
<br> 5 One or more of the following signs/symptoms must be present within 24 hours prior to Day 1: ? Cough ? Sore throat ? Shortness of breath or difficulty breathing at rest or with activity ? Body pain or muscle pain/aches ? Fatigue ? Headache ? Chills ? Nasal obstruction or congestion ? Nasal discharge ? Nausea or vomiting ? Diarrhea ? New loss of taste or smell
<br> 6 Oxygenation saturation of = 92% obtained at rest by study staff within 24 hours prior to Day 1, unless the potential participant regularly receives chronic supplementary oxygen for an underlying lung condition.
<br> Participation in another COVID-19 treatment trial 7 Agrees not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days post-entry, whichever is earliest.
<br> Reproduction 8 Contraceptive use by men or women. (a) Male participants: Contraception for male participants is not required; however, to avoid the transfer of any fluids, all male participants must use a condom from Day 1 and agree to continue through 365 days following administration of IMP. (b) Female participants: ??Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply: o Women < 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle-stimulating hormone levels in the postmenopausal range. o Women = 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. ??Women of c | Exclusion criteria:
<br> Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: Age 1 Participant must be = 18 years of age inclusive at the time of signing the informed consent.
<br> Age 1 Participant must be = 18 years of age inclusive at the time of signing the informed consent.
<br> Type of Participant and Disease Characteristics 2 Participant who has a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (eg, oropharyngeal, NP, or nasal swab, or saliva) collected = 3 days prior to Day 1.
<br>
<br> 3 WHO Clinical Progression Scale score > 0 and <4
<br> 4 Participant must be dosed with IMP no more than 7 days from self-reported onset of COVID-19-related symptoms (mild to moderate COVID) or measured fever, defined as the self-reported date of first reported sign/symptom from the following list: ? Subjective fever or feeling feverish ? Cough ? Shortness of breath or difficulty breathing at rest or with activity ? Sore throat ? Body pain or muscle pain/aches ? Fatigue ? Headache ? Chills ? Nasal obstruction or congestion ? Nasal discharge ? New loss of taste or smell ? Nausea or vomiting ? Diarrhea ? Documented temperature > 37.8° C ? New onset confusion (only for participants = 60 years old) ? Appetite loss or decreased food intake (only for participants = 60 years old) ? Increased supplemental oxygen requirement (only for participants on baseline supplemental oxygen)
<br> 5 One or more of the following signs/symptoms must be present within 24 hours prior to Day 1: ? Cough ? Sore throat ? Shortness of breath or difficulty breathing at rest or with activity ? Body pain or muscle pain/aches ? Fatigue ? Headache ? Chills ? Nasal obstruction or congestion ? Nasal discharge ? Nausea or vomiting ? Diarrhea ? New loss of taste or smell
<br> 6 Oxygenation saturation of = 92% obtained at rest by study staff within 24 hours prior to Day 1, unless the potential participant regularly receives chronic supplementary oxygen for an underlying lung condition.
<br> Participation in another COVID-19 treatment trial 7 Agrees not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days post-entry, whichever is earliest.
<br>
<br> Reproduction 8 Contraceptive use by men or women. (a) Male participants: Contraception for male participants is not required; however, to avoid the transfer of any fluids, all male participants must use a condom from Day 1 and agree to continue through 365 days following administration of IMP. (b) Female participants: ??Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply: o Women <50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle-stimulating hormone levels in the postmenopausal range. o Women = 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal trea→Exclusion criteria: Inclusion Criteria Participants are eligible to be included in the study only if all of the following criteria apply: Age 1 Participant must be = 18 years of age inclusive at the time of signing the informed consent.
<br> Age 1 Participant must be = 18 years of age inclusive at the time of signing the informed consent.
<br> Type of Participant and Disease Characteristics 2 Participant who has a documented laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test (antigen or nucleic acid) from any respiratory tract specimen (eg, oropharyngeal, NP, or nasal swab, or saliva) collected = 3 days prior to Day 1.
<br> 3 WHO Clinical Progression Scale score > 0 and < 4
<br> 4 Participant must be dosed with IMP no more than 7 days from self-reported onset of COVID-19-related symptoms (mild to moderate COVID) or measured fever, defined as the self-reported date of first reported sign/symptom from the following list: ? Subjective fever or feeling feverish ? Cough ? Shortness of breath or difficulty breathing at rest or with activity ? Sore throat ? Body pain or muscle pain/aches ? Fatigue ? Headache ? Chills ? Nasal obstruction or congestion ? Nasal discharge ? New loss of taste or smell ? Nausea or vomiting ? Diarrhea ? Documented temperature > 37.8° C ? New onset confusion (only for participants = 60 years old) ? Appetite loss or decreased food intake (only for participants = 60 years old) ? Increased supplemental oxygen requirement (only for participants on baseline supplemental oxygen)
<br> 5 One or more of the following signs/symptoms must be present within 24 hours prior to Day 1: ? Cough ? Sore throat ? Shortness of breath or difficulty breathing at rest or with activity ? Body pain or muscle pain/aches ? Fatigue ? Headache ? Chills ? Nasal obstruction or congestion ? Nasal discharge ? Nausea or vomiting ? Diarrhea ? New loss of taste or smell
<br> 6 Oxygenation saturation of = 92% obtained at rest by study staff within 24 hours prior to Day 1, unless the potential participant regularly receives chronic supplementary oxygen for an underlying lung condition.
<br> Participation in another COVID-19 treatment trial 7 Agrees not to participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days post-entry, whichever is earliest.
<br> Reproduction 8 Contraceptive use by men or women. (a) Male participants: Contraception for male participants is not required; however, to avoid the transfer of any fluids, all male participants must use a condom from Day 1 and agree to continue through 365 days following administration of IMP. (b) Female participants: ??Women not of childbearing potential are defined as women who are either permanently sterilized (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal. Women will be considered postmenopausal if they have been amenorrheic for 12 months prior to the planned date of randomization without an alternative medical cause. The following age-specific requirements apply: o Women < 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatment and follicle-stimulating hormone levels in the postmenopausal range. o Women = 50 years old would be considered postmenopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatment. ??Women of childbe | B972 CORONAVIRUS COMO CAUSA DE ENFERMEDADES CLASIFICADAS EN OTROS CAPITULOS <br>Coronavirus as the cause of diseases classified to other chapters;B972;Coronavirus as the cause of diseases classified to other chapters | Patients will receive a single 600 mg dose IM of AZD7442 on Day 1, plus the standard of care treatment for COVID-19, monitored for up to one year after IMP administration. - Patients will receive a single 600 mg dose IM of Placebo of AZD7442 on Day 1, plus the standard of care treatment for COVID-19, monitored for up to one year after IMP administration. | To estimate the efficacy of AZD7442 in the prevention of the composite endpoint of either severe COVID-19 or death from any cause through study Day 29 NAME OF THE RESULT: A composite of either severe COVID-19 or death from any cause through Day 29. PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: 28-day post-dose period (Day 1 to Day 29). ;To evaluate safety and tolerability of a single IM dose of AZD7442 compared to placebo. NAME OF THE RESULT: AEs, SAEs, and AESIs through 365 days post dose of IMP PERIOD OF TIME WHERE TE MEASUREMENT WILL BE CONDUCTED AND WHICH WILL ALLOW OBTAINING THE PRIMARY RESULT: During the study | | | | Yes | False | | |
| → | NCT04323839 | 12 December 2020→15 November 2021 | COVID-19 PRIORITY (Pregnancy CoRonavIrus Outcomes RegIsTrY) | PRIORITY (Pregnancy Coronavirus Outcomes Registry) | PRIORITY | University of California, San Francisco | 24/03/2020 | 20200324 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04323839 | Recruiting→Not recruiting | No | 13 Years | N/A | Female | March 20, 2020 | 2000→1333 | Observational [Patient Registry] | | | United States | | Vanessa Jacoby, MD, MAS | | | | University of California, San Francisco |
<br> Inclusion Criteria:
<br>
<br> 1. Pregnant women or women who have been pregnant within the last 6 weeks
<br>
<br> 2. Able to give informed consent
<br>
<br> 3. Diagnosed with COVID-19; or being evaluated for COVID-19 ("patient under
<br> investigation") since January 1, 2020
<br>
<br> Exclusion Criteria:
<br>
<br> 1. <13 years of age.
<br> | | Pregnancy;Coronavirus;COVID-19 | Other: Pregnant women under investigation for Coronavirus or diagnosed with COVID-19;Other: Postpartum women under investigation for Coronavirus or diagnosed with COVID-19 | Modes of transmission of COVID-19;Neonatal outcomes;Obstetric outcomes;Pregnancy outcomes;Disease prognosis outcomes;Clinical presentation | | | | Yes | False | | |
| → | NCT04327505 | 28 June 2021→15 November 2021 | Safety and Efficacy of Hyperbaric Oxygen for ARDS in Patients With COVID-19 | A Randomized, Controlled, Open Label, Multicentre Clinical Trial to Explore Safety and Efficacy of Hyperbaric Oxygen for Preventing ICU Admission, Morbidity and Mortality in Adult Patients With COVID-19 | COVID-19-HBO | Karolinska Institutet | 25/03/2020 | 20200325 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04327505 | Recruiting | Yes | 18 Years | 90 Years | All | June 3, 2020 | 200 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2/Phase 3 | Romania;Sweden;Germany;Sweden;Germany | ; ; ; | Anders Kjellberg, MD;Peter Lindholm, MD, PhD;Kenny Rodriguez-Wallberg, MD, PhD;Anders Kjellberg, MD | | ;;;anders.kjellberg@ki.se | ;;;+46812375212 | Karolinska Institutet;Karolinska Institutet;Karolinska Institutet; |
<br> Inclusion criteria:
<br>
<br> 1. Aged 18-90 years
<br>
<br> 2. PaO2/FiO2 (PFI) below 200 mmHg (26.7 kPa)
<br>
<br> 3. Suspected or verified SARS-CoV-2 infection
<br>
<br> 4. At least two risk factors for increased morbidity/mortality
<br>
<br> - Age above 50 years
<br>
<br> - Hypertension
<br>
<br> - Cardiovascular disease
<br>
<br> - Diabetes or pre-diabetes
<br>
<br> - Active or cured cancer
<br>
<br> - Asthma/COPD
<br>
<br> - Smoking
<br>
<br> - D-Dimer > 1.0 mg/L
<br>
<br> - Auto-immune disease
<br>
<br> 5. Documented informed consent according to ICH-GCP and national regulations
<br>
<br> Exclusion Criteria:
<br>
<br> 1. ARDS/pneumonia caused by other viral infections (positive for other virus)
<br>
<br> 2. ARDS/pneumonia caused by other non-viral infections or trauma
<br>
<br> 3. Known pregnancy or positive pregnancy test in women of childbearing age
<br>
<br> 4. Patients with previous lung fibrosis more than 10%
<br>
<br> 5. CT- or Spirometry-verified severe COPD with Emphysema
<br>
<br> 6. Contraindication for HBO according to local guidelines
<br>
<br> 7. Not likely to need ICU admission < 7 days of screening (Subjective criteria that may
<br> exclude any patients that fulfil the other inclusion criteria but where the treating
<br> physician suspect a spontaneous recovery)
<br>
<br> 8. Mental inability, reluctance or language difficulties that result in difficulty
<br> understanding the meaning of study participation
<br>
<br> 9. Prisoner (Exclusion criteria according to IRB at UCSD)
<br> | | SARS (Severe Acute Respiratory Syndrome);Cytokine Storm;ARDS, Human;COVID-19;Sars-CoV2;Acute Respiratory Failure | Drug: Hyperbaric oxygen | ICU admission | | | | Yes | True | parent | |
| → | NCT04348656 | 5 July 2021→15 November 2021 | CONvalescent Plasma for Hospitalized Adults With COVID-19 Respiratory Illness (CONCOR-1) | A Randomized Open-Label Trial of CONvalenscent Plasma for Hospitalized Adults With Acute COVID-19 Respiratory Illness (CONCOR-1) | CONCOR-1 | Hamilton Health Sciences Corporation | 13/04/2020 | 20200413 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04348656 | Not recruiting | No | 16 Years | N/A | All | March 14, 2020 | 940 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | United States;Brazil;Canada;Brazil;Canada;United States→United States;Canada;Brazil;Canada;Brazil;United States | | Donald M Arnold, MD | | | | McMaster University |
<br> Inclusion Criteria:
<br>
<br> - =16 years old (>18 years of age in the United States)
<br>
<br> - Admitted to hospital with confirmed COVID-19 respiratory illness
<br>
<br> - Receiving supplemental oxygen
<br>
<br> - 500 mL of ABO compatible convalescent plasma is available
<br>
<br> Exclusion Criteria:
<br>
<br> - Onset of symptoms >12 days prior to randomization
<br>
<br> - Intubated or plan in place for intubation
<br>
<br> - Plasma is contraindicated (e.g. history of anaphylaxis from transfusion)
<br>
<br> - Decision in place for no active treatment
<br> →
<br> Inclusion Criteria:
<br>
<br> - =16 years old (>18 years of age in the United States)
<br>
<br> - Admitted to hospital with confirmed COVID-19 respiratory illness
<br>
<br> - Receiving supplemental oxygen
<br>
<br> - 500 mL of ABO compatible convalescent plasma is available
<br>
<br> Exclusion Criteria:
<br>
<br> - Onset of respiratory symptoms >12 days prior to randomization
<br>
<br> - Intubated or plan in place for intubation
<br>
<br> - Plasma is contraindicated (e.g. history of anaphylaxis from transfusion)
<br>
<br> - Decision in place for no active treatment
<br> | | COVID-19 | Biological: Convalescent plasma | Intubation or death | | | | Yes | False | | |
| → | NCT04353206 | 12 December 2020→15 November 2021 | Convalescent Plasma in ICU Patients With COVID-19-induced Respiratory Failure | A Feasibility Study Assessing the Safety of Multiple Doses of Anti-SARS-CoV-2 Plasma in Mechanically Ventilated Intubated Patients With Respiratory Failure Due to COVID-19 | | Noah Merin | 16/04/2020 | 20200416 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04353206 | Recruiting→Not recruiting | No | 18 Years | N/A | All | June 27, 2020 | 60→6 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Early Phase 1 | United States | ; ; → ; | Noah Merin, MD PhD;David Hager, MD PhD;Noah Merin, MD PhD→Noah Merin, MD PhD;David Hager, MD PhD | | ;;Noah.Merin@cshs.org→; | ;;310-423-1160→; | Cedars-Sinai Medical Center;Johns Hopkins University;→Cedars-Sinai Medical Center;Johns Hopkins University |
<br> Inclusion Criteria:
<br>
<br> - 18 years of age or older
<br>
<br> - Respiratory failure requiring mechanical ventilation due to COVID-19 induced pneumonia
<br> with confirmation via SARS-CoV-2 RT-PCR testing
<br>
<br> - PaO2/FiO2 ratio < 300 (or SpO2/FiO2 < 315)
<br>
<br> - Bilateral pulmonary infiltrates
<br>
<br> Exclusion Criteria:
<br>
<br> - Contraindication to transfusion (severe volume overload, history of anaphylaxis to
<br> blood products).
<br>
<br> - In the opinion of the site investigator or primary clinical care team, anticipated to
<br> die within 48 hours.
<br>
<br> - Acute or chronic disease/illness that, in the opinion of the site investigator, has an
<br> expected life expectancy of less than 28 days unrelated to COVID-19 induced pneumonia
<br> (e.g.; stage IV malignancy, neurodegenerative disease, anoxic brain injury, etc.)
<br>
<br> - Use of home oxygen at baseline
<br>
<br> - Use of home mechanical ventilation at baseline (CPAP or BIPAP without need for oxygen
<br> is NOT an exclusion)
<br>
<br> - Respiratory failure caused by illness other than SARS-CoV-2
<br>
<br> - Other documented uncontrolled infection.
<br>
<br> - More than 72 hours have elapsed since first meeting inclusion criteria
<br>
<br> - Severe DIC, TTP, or antithrombin III deficiency needing factor replacement, FFP,
<br> cryoprecipitate.
<br>
<br> - Patient is on Warfarin and it is deemed necessary to maintain therapeutic INR (because
<br> the CP will reverse the warfarin effect).
<br>
<br> - On dialysis at the time enrollment is considered.
<br>
<br> - Active intracranial bleeding.
<br>
<br> - Clinically significant myocardial ischemia.
<br>
<br> - Prisoner or Incarceration
<br>
<br> - Pregnancy or active breast feeding
<br>
<br> - Has already received convalescent plasma for COVID-19 infection during current
<br> admission
<br>
<br> - Current participation in another interventional research study
<br>
<br> - Inability or unwillingness of subject or legal surrogate/representative to give
<br> written informed consent
<br> | | Covid-19;Sars-CoV2 | Biological: Multiple Doses of Anti-SARS-CoV-2 convalescent plasma | Proportion of subjects who consent to the study and receive at least one dose of convalescent plasma. | | | | Yes | False | | |
| → | NCT04354831 | 18 January 2021→15 November 2021 | A Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection | An Open Label, Phase 2 Study Evaluating the Efficacy and Safety of High-Titer Anti-SARS-CoV-2 Plasma in Hospitalized Patients With COVID-19 Infection | | Medical College of Wisconsin | 14/04/2020 | 20200414 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04354831 | Not recruiting | No | 18 Years | N/A | All | May 11, 2020 | 131 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | | Mary Beth Graham | | | | Medical College of Wisconsin |
<br> Inclusion Criteria:
<br>
<br> 1. Age = 18 years or older
<br>
<br> 2. Hospitalized as an in-patient with positive COVID-19 test by PCR
<br>
<br> 3. Presence of respiratory symptoms with any of severe features as below:
<br>
<br> - Respiratory Rate = 24/min
<br>
<br> - Oxygen Support >3L/min by nasal cannula
<br>
<br> - New onset or worsening of respiratory symptoms with radiologic confirmation of
<br> bilateral ground glass opacities that cannot be attributed to another cause
<br>
<br> 4. Patient / HCPOA must agree to storage of blood specimens for future testing.
<br>
<br> 5. Patient / HCPOA is willing and able to provide electronic informed consent and comply
<br> with all protocol requirements. If patient is unable to consent due to incapacity,
<br> health care POA should be defined and able to consent for the patient.
<br>
<br> 6. Patients are allowed to receive all standard of care. Co enrollment in other clinical
<br> trials is permitted.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. FCBP with positive pregnancy test (mandatory)
<br>
<br> 2. Breastfeeding females
<br>
<br> 3. Receipt of pooled immunoglobulin (e.g. IVIG or other hyperimmune globulin products) in
<br> past 14 days. This does not apply to monoclonal antibodies .
<br>
<br> 4. Mechanical ventilation for > 14 days
<br>
<br> 5. Days from symptom onset >21 days
<br>
<br> 6. Expected survival < 72 hours
<br>
<br> 7. Contraindication to transfusion or history of prior reactions to transfusion blood
<br> products including any proven history of TRALI
<br>
<br> 8. Patients who were previously admitted to ICU cannot be enrolled in the non-ICU cohort.
<br> These patients could need ICU level care subsequently and at that time point could be
<br> considered for ICU cohort .
<br> | | COVID-19 | Biological: anti-SARS-CoV-2 convalescent plasma | Overall Mortality within 60 days | | | | Yes | False | | |
| → | NCT04359654 | 12 December 2020→15 November 2021 | Nebulised Dornase Alfa for Treatment of COVID-19 | A Single-site, Randomised, Controlled, Parallel Design, Open-label Investigation of an Approved Nebulised Recombinant Human DNase Enzyme (Dornase Alfa) to Reduce Hyperinflammation in Hospitalised Participants With COVID-19 | COVASE | University College, London | 21/04/2020 | 20200421 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04359654 | Recruiting→Not recruiting | No | 18 Years | 100 Years | All | June 16, 2020 | 50→41 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United Kingdom | ; ; → | Joanna Porter, MD PhD;Misha Ladva;Joanna Porter, MD PhD→Joanna Porter, MD PhD | | ;misha.ladva@ucl.ac.uk;joanna.porter@ucl.ac.uk→ | ;0044 20 3108 6223;0044 20 3447 9102→ | University College, London;→University College, London |
<br> Inclusion Criteria:
<br>
<br> 1. Male and female participants, aged = 18 years.
<br>
<br> 2. Participants who are hospitalised for suspected Coronavirus (SARS-CoV)-2 infection
<br> confirmed by polymerase chain reaction (PCR) test or radiological confirmation.
<br>
<br> 3. Participants with stable oxygen saturation (>=94%) on supplementary oxygen
<br>
<br> 4. CRP >= 30 mg/L.
<br>
<br> 5. Participants will have given their written informed consent to participate in the
<br> study and are able to comply with instructions and nebuliser.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Females who are pregnant, planning pregnancy or breastfeeding.
<br>
<br> 2. Concurrent and/or recent involvement in other research or use of another experimental
<br> investigational medicinal product that is likely to interfere with the study
<br> medication within the last 3 months before study enrolment.
<br>
<br> 3. Serious condition meeting one of the following:
<br>
<br> I. respiratory distress with respiratory rate >=40 breaths/min II. oxygen saturation
<br> <=93% on high-flow oxygen
<br>
<br> 4. Require mechanical invasive or non-invasive ventilation at screening
<br>
<br> 5. Concurrent severe respiratory disease such as asthma, COPD and/or ILD.
<br>
<br> 6. Any major disorder that in the opinion of the Investigator would interfere with the
<br> evaluation of the results or constitute a health risk for the study participant.
<br>
<br> 7. Terminal disease and life expectancy <12 months without COVID-19.
<br>
<br> 8. Known allergies to the dornase alfa and excipients.
<br>
<br> 9. Participants who are unable to inhale or exhale orally throughout the entire
<br> nebulisation period.
<br> | | COVID19;Hypoxia | Drug: Dornase Alfa Inhalation Solution [Pulmozyme] | Measuring the change in inflammation | | | | Yes | False | | |
| → | NCT04362176 | 13 September 2021→15 November 2021 | Passive Immunity Trial for Our Nation to Treat COVID-19 in Hospitalized Adults | Passive Immunity Trial for Our Nation (PassItOn) | PassItOn | Vanderbilt University Medical Center | 21/04/2020 | 20200421 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04362176 | Recruiting→Not recruiting | No | 18 Years | N/A | All | April 24, 2020 | 1000→974 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Outcomes Assessor). | Phase 3 | United States | ; → | Todd Rice, MD;Amanda J Bistran-Hall→Todd Rice, MD | | ;amanda.j.bistran-hall@vumc.org→ | ;(615) 875-8531→ | Vanderbilt University Medical Center;→Vanderbilt University Medical Center |
<br> Inclusion Criteria:
<br>
<br> 1. Age greater than or equal to 18 years
<br>
<br> 2. Currently hospitalized or in an emergency department with anticipated hospitalization
<br>
<br> 3. Symptoms of acute respiratory infection, defined as one or more of the following:
<br>
<br> 1. Cough
<br>
<br> 2. Chills, or a fever (greater than 37.5° C or 99.5° F)
<br>
<br> 3. Shortness of breath, operationalized as a patient having any of the following:
<br>
<br> i. Subjective shortness of breath reported by a patient or surrogate. ii. Tachypnea
<br> with respiratory rate of greater than 22 breaths per minute iii. Hypoxemia, defined as
<br> SpO2 less than 92% on room air, new receipt of supplemental oxygen to maintain SpO2
<br> greater than or equal to 92%, or increased supplemental oxygen to maintain SpO2
<br> greater than or equal to 92% for a patient on chronic oxygen therapy
<br>
<br> 4. Laboratory-confirmed SARS-CoV-2 infection within the past 14 days
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Prisoner
<br>
<br> 2. Unable to randomize within 14 days after onset of acute respiratory infection symptoms
<br>
<br> 3. Patient, legal representative, or physician not committed to full support (Exception:
<br> a patient who will receive all supportive care except for attempts at resuscitation
<br> from cardiac arrest will not be excluded.)
<br>
<br> 4. Inability to be contacted on Day 29-36 for clinical outcome assessment
<br>
<br> 5. Receipt of any SARS-CoV-2 passive immunity therapy, such as convalescent plasma,
<br> monoclonal antibodies, or pooled immunoglobulin, in the past 30 days
<br>
<br> 6. Contraindications to transfusion or history of prior reactions to transfused blood
<br> products
<br>
<br> 7. Plan for hospital discharge within 24 hours of enrollment
<br>
<br> 8. Previous enrollment in this trial
<br>
<br> 9. Previous laboratory-confirmed SARS-CoV-2 infection before the current illness
<br>
<br> 10. Enrollment in another clinical trial evaluating monoclonal antibodies, convalescent
<br> plasma, or another passive immunity therapy
<br>
<br> 11. Prior receipt of SARS-CoV-2 vaccine
<br> | | COVID-19;Coronavirus;SARS-CoV-2 | Biological: pathogen reduced SARS-CoV-2 convalescent plasma;Biological: Placebo | COVID-19 7-point Ordinal Clinical Progression Outcomes Scale | | | | Yes | False | | |
| → | NCT04363814 | 12 December 2020→15 November 2021 | Clinical Impact of BACTEK-R in Subject With Mild Pneumonia Due to COVID-19 Infection | A Prospective, Open-label, Randomized Pilot Study (Including a Control Group) of BACTEK-R (MV130), Administered Sublingually to Assess the Clinical Impact in Subjects With Mild Pneumonia Due to COVID-19 | | Inmunotek S.L. | 19/04/2020 | 20200419 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04363814 | Recruiting→Not recruiting | No | 18 Years | 70 Years | All | June 10, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | Dominican Republic | ; ; ; ; ; ; ; → ; ; ; ; ; | Martín Medrano, MD;Nicolas Batlle, MD;Raymundo Hernández;Natalia García;M. Polanco;Guillermo Ángeles;Guillermo Ángeles, MD;Nicolas Batlle, MD→Martín Medrano, MD;Nicolas Batlle, MD;Raymundo Hernández;Natalia García;M. Polanco;Guillermo Ángeles | | ;;;;;;gangeles@gmail.com;→;;;;; | ;;;;;;809 399 3520;+1 829-947-2222→;;;;; | ;;;;;;→;;;;; |
<br> Inclusion Criteria:
<br>
<br> 1. - Subjects who voluntarily sign informed consent forms
<br>
<br> 2. - Both genders.
<br>
<br> 3. - Subjects aged between 18 and 70 years.
<br>
<br> 4. -Subjects capable of complying with the treatment
<br>
<br> 5. - Subjects admitted to hospital with non-severe pneumonia (CURB-65=2) by COVID-19
<br>
<br> 6. - Confirmatory test for COVID-19 infection
<br>
<br> Exclusion Criteria:
<br>
<br> 1. - Subjects who has not signed informed consent forms
<br>
<br> 2. - Subjects included in another clinical trial.
<br>
<br> 3. - Subjects under treatment with immunosuppressants.
<br>
<br> 4. - Subjects in treatment with another type of immunotherapy.
<br>
<br> 5. - Subjects who are or have been undergoing treatment with metformin.
<br>
<br> 6. - Subjects who are or have been treated with statins.
<br>
<br> 7. - Subjects who are or have been under treatment with sertraline.
<br>
<br> 8. - Pregnant women.
<br>
<br> 9. - Subjects who cannot offer cooperation and / or have serious psychiatric disorders.
<br>
<br> 10. -Subjects who are allergic to any of the components of BACTEK-R (MV130).
<br>
<br> 11. - Subjects with pathologies described in the Charlson index
<br> | | COVID-19 | Biological: Bactek-R | Clinical recovery;Clinical worsening | | | | Yes | False | | |
| → | NCT04375735 | 12 December 2020→15 November 2021 | London's Exogenous Surfactant Study for COVID19 | Phase I/II Trial: Exogenous Surfactant Administration for Patients With COVID-19 | LESSCOVID | Lawson Health Research Institute | 22/04/2020 | 20200422 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04375735 | Not recruiting | No | 18 Years | N/A | All | July 1, 2020→November 23, 2020 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1/Phase 2 | →Canada | ; → | Jim Lewis, MD;Gordon Barkwell, MSc→Jim Lewis, MD | | ;gordon.barkwell@lhsc.on.ca→ | ;519-685-8500→ | Lawson Health Research Institute;→Lawson Health Research Institute |
<br> Inclusion Criteria:
<br>
<br> 1. age over 18 years
<br>
<br> 2. definitive proof of COVID-19 infection within 48 hours of intubation
<br>
<br> 3. acute respiratory failure with PaO2/FiO2 < 300 requiring intubation
<br>
<br> Exclusion Criteria:
<br>
<br> 1. known or high suspicion of pre-existing heart failure, unstable angina
<br>
<br> 2. presence of severe shock with hemodynamic instability despite escalating vasopressors
<br>
<br> 3. severe, underlying lung disease (COPD, pulmonary fibrosis, lung cancer. etc.)
<br>
<br> 4. Concurrent treatments are delivered directly into the lung (ie anesthetics etc)
<br>
<br> 5. Diagnosis of pulmonary hemorrhage
<br> | | ARDS, Human;COVID-19 | Drug: Bovine Lipid Extract Surfactant | Adverse events (patient) - Decrease in oxygenation;Adverse events (patient) - Decrease in hemodynamics;Adverse event (healthcare worker) - Circuit breach;Adverse event (healthcare worker) - COVID-19 symptoms→Adverse event (healthcare worker) - COVID-19 symptoms;Adverse event (healthcare worker) - Circuit breach;Adverse events (patient) - Decrease in hemodynamics;Adverse events (patient) - Decrease in oxygenation | | | | Yes | False | | |
| → | NCT04377100 | 1 November 2021→15 November 2021 | Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses | Impact on Anxiety and Motivation of COVID-19 and Predictors of Individual Responses | | National Institute of Mental Health (NIMH) | 05/05/2020 | 20200505 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04377100 | Recruiting | No | 18 Years | N/A | All | November 3, 2021→November 18, 2021 | 6000 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label). | N/A | United States | ; ; | Monique Ernst, M.D.;Morgan Andrews, Ph.D.;Morgan Andrews, Ph.D. | | ;deborah.roberts@nih.gov;deborah.roberts@nih.gov | ;(301) 594-0642;301-594-0642 | National Institute of Mental Health (NIMH); |
<br> - INCLUSION CRITERIA:
<br>
<br> In order to be eligible to participate in this study, an individual must meet all of the
<br> following criteria:
<br>
<br> 1. 18 years of age and older.
<br>
<br> 2. Able to read and write English.
<br>
<br> 3. Able to provide informed consent online using study website.
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> There are no exclusion criteria for this study.
<br> | | Anxiety;Healthy Volunteers | Behavioral: Computer task questionnaires | Patterns of neural connectivity as predictors | | | | Yes | False | | |
| → | NCT04384055 | 5 July 2021→15 November 2021 | Predicting Outcomes for Covid-19 Using Sonography | Predicting Outcomes for Covid-19 Using Sonography | POCUS | Stanford University | 08/05/2020 | 20200508 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04384055 | Recruiting→Not recruiting | No | 18 Years | N/A | All | March 21, 2020 | 200→165 | Observational | | | United States | ; | Andre D Kumar, MD, MEd;Sally Graglia, MD, MPH | | ; | ; | Stanford University;University of California, San Francisco |
<br> Inclusion Criteria:
<br>
<br> - Any adult (18 or more years of age) presenting to the emergency department with
<br> symptoms suspicious for Covid-19
<br>
<br> - This individual underwent evaluation for Covid-19 via a nasopharyngeal RT-PCR
<br>
<br> - This individual received a lung ultrasound by the study authors within 28 days from
<br> initial evaluation
<br>
<br> Exclusion Criteria:
<br>
<br> - Any individual who did not receive a lung ultrasound within 28 days from initial
<br> evaluation for covid-19 related illness
<br> | | COVID-19;Pneumonia, Viral | Diagnostic Test: Lung Ultrasound | Number of Patients Experiencing Death, ICU Admission, Mechanical Ventilation, or Use of High-Flow Nasal Cannula | | | | Yes | False | | |
| → | NCT04385160 | 22 February 2021→15 November 2021 | Myeloproliferative Neoplasms (MPN) and COVID-19 | Myeloproliferative Neoplasms (MPN) and COVID-19 | MPN-COVID | Fondazione per la Ricerca Ospedale Maggiore | 11/05/2020 | 20200511 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04385160 | Recruiting | No | 18 Years | N/A | All | May 13, 2020 | 552 | Observational | | | United States;France;Germany;Italy;Poland;Spain;United Kingdom;France;Germany;Italy;Poland;Spain;United Kingdom;United States;Denmark→United States;Croatia;France;Germany;Italy;Poland;Spain;United Kingdom;Croatia;France;Germany;Italy;Poland;Spain;United Kingdom;United States;Denmark | ; | Tiziano Barbui, Prof;Arianna Masciulli, PharmD | | ;amasciulli@fondazionefrom.it | ;0352678926 | Fondazione per la Ricerca Ospedale di Bergamo; |
<br> Inclusion Criteria:
<br>
<br> - Age > 18 years
<br>
<br> - Confirmed diagnosed of MPN according to WHO criteria
<br>
<br> - Diagnosis of COVID-19 based by the positivity of oropharyngeal swab performed between
<br> 15 February 2020 up to 15 February 2022
<br>
<br> - Signed informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - None
<br> | | Myeloproliferative Neoplasm;COVID | | pulmonary embolism (PE) | | | | Yes | False | | |
| → | NCT04387656 | 1 November 2021→15 November 2021 | NCI COVID-19 in Cancer Patients, NCCAPS Study | NCI COVID-19 in Cancer Patients Study (NCCAPS): A Longitudinal Natural History Study | | National Cancer Institute (NCI) | 13/05/2020 | 20200513 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04387656 | Recruiting | No | N/A | N/A | All | May 21, 2020 | 2000 | Observational | | | United States;Canada;Puerto Rico;Canada;Puerto Rico;United States | | Larissa A Korde | | | | National Cancer Institute (NCI) |
<br> Inclusion Criteria:
<br>
<br> - NCCAPS STUDY ELIGIBILITY CRITERIA:
<br>
<br> - Patient must have a prior or current cancer diagnosis (e.g., solid tumor or
<br> hematologic malignancy) and cancer treatment that fits into one of the three following
<br> categories:
<br>
<br> - Metastatic (stage IV) solid tumor, any hematologic malignancy, or any central
<br> nervous system (CNS) malignancy, and:
<br>
<br> - Patient is receiving eligible active treatment (defined as current treatment
<br> or treatment within the 6 weeks prior to their first positive SARS-CoV-2
<br> test collection) or is expected to begin receiving treatment within 2 weeks
<br> of study enrollment
<br>
<br> - Eligible active treatment types are chemotherapy, immunotherapy, monoclonal
<br> antibody therapy (e.g., rituximab, trastuzumab, cetuximab), targeted therapy
<br> (e.g., BRAF/MEK inhibitor, EGF-R inhibitor), endocrine therapy, radiation
<br> therapy, or targeted radionuclide therapy; OR
<br>
<br> - Non-metastatic (Stage I-III) solid tumor and:
<br>
<br> - Patient is receiving eligible active treatment (defined as current treatment
<br> or treatment within past 6 weeks prior to their first positive SARS-CoV-2
<br> test collection) or is expected to begin receiving treatment within 2 weeks
<br> of study enrollment
<br>
<br> - Eligible active treatment types for non-metastatic solid tumor patients are
<br> intravenous chemotherapy, immunotherapy, targeted therapy, radiation
<br> therapy, targeted radionuclide therapy, or monoclonal antibody therapy
<br> (except as noted below)
<br>
<br> - HER2-targeted therapy (trastuzumab, pertuzumab, neratinib,
<br> ado-trastuzumab) that is not accompanied by chemotherapy is NOT
<br> considered an eligible active treatment
<br>
<br> - Patients on endocrine therapy alone are not eligible; OR
<br>
<br> - Prior or current transplant for the treatment of cancer:
<br>
<br> - Patient has received an allogenic stem cell/bone marrow transplant or
<br> chimeric antigen receptor (CAR)-T cell or other modified cellular therapy at
<br> any time; or
<br>
<br> - Patient is currently receiving treatment or prophylaxis for graft graft
<br> versus (vs.) host disease; or
<br>
<br> - Patient has received an autologous stem cell/bone marrow transplant within
<br> the past 2 years
<br>
<br> - Patient must have documented positive viral test result for SARS-CoV-2
<br>
<br> - For patients 18 years of age or older, the specimen collection for the patient's
<br> FIRST positive test must have occurred no earlier than 14 days prior to
<br> enrollment
<br>
<br> - For patients under 18 years of age, the specimen collection for the patient's
<br> first positive test must have occurred after January 31, 2020
<br>
<br> - The viral test can be either a nucleic acid (PCR) test or an antigen test.
<br> Serological or antibody tests are not allowed
<br>
<br> - Any specimen source (e.g., nasopharyngeal swab, oropharyngeal swab, etc.) is
<br> allowable for the viral SARS-CoV-2 test
<br>
<br> - Patients with prior negative viral SARS-CoV-2 test(s) are eligible if they are
<br> being tested again
<br>
<br> - The SARS-CoV-2 test must be a validated diagnostic assay performed in accordance
<br> with the most recent guidance issued by the FDA in the Policy for Coronavirus
<br> Disease-2019 Tests During the Public Health Emergency. This policy is available
<br> at:
<br> https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-c
<br> oronavirus-disease-2019-tests-during-public-health-emergency-revised
<br>
<br> - Human immunodeficiency virus (HIV)-infected patients are eligible
<br>
<br> - Patients with CNS metastases are eligible
<br>
<br> - Co-enrollment on other clinical trials (for cancer or for COVID-19) is allowed
<br>
<br> - PEDIATRIC COVNET COHORT ELIGIBILITY CRITERIA:
<br>
<br> Patients should only be enrolled in the pediatric COVNET cohort if they are not eligible
<br> for the main NCCAPS Study cohort or decline to participate in the main study
<br>
<br> - Patient must be < 18 years of age
<br>
<br> - Patient must have a positive SARS-CoV-2 viral test after January 31, 2020
<br>
<br> - Patient must have a current or prior diagnosis of cancer. Active cancer treatment is
<br> not required
<br>
<br> - Note: Patients who enroll on Pediatric COVNET cohort will not be followed
<br> longitudinally; study data collection involves only a single questionnaire and
<br> research blood collection. A separate consent document is provided for the Pediatric
<br> COVNET cohort
<br> | | COVID-19 Infection;Hematopoietic and Lymphoid Cell Neoplasm;Malignant Solid Neoplasm;Metastatic Malignant Solid Neoplasm | Procedure: Biospecimen Collection;Other: Data Collection;Other: Quality-of-Life Assessment;Other: Questionnaire Administration | Patient variables (factors) associated with severe acute respiratory syndrome (SARS) coronavirus 2 (COVID-19) severity;Effects of COVID-19 on cancer therapy and association with clinical outcomes;Physical health (patient-reported health-related quality of life) | | | | Yes | False | | |
| → | NCT04388605 | 14 June 2021→15 November 2021 | Assessing the Safety of Pregnancy In the CoRonavirus (COVID-19) pandEmic | Assessing the Safety of Pregnancy In the CoRonavirus pandEmic: a Nationwide Prospective Study | ASPIRE | University of California, San Francisco | 07/05/2020 | 20200507 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04388605 | Recruiting | No | 18 Years | N/A | Female | April 21, 2020 | 11000 | Observational [Patient Registry] | | | United States | ; ; | Heather Huddleston, MD;Heather Huddleston, MD;Heather Huddleston | | ;heather.huddleston@ucsf.edu;heather.huddleston@ucsf.edu | ;415-353-3040;415-353-3040 | University of California, San Francisco; |
<br> Inclusion Criteria:
<br>
<br> - Over age 18
<br>
<br> - Participant is 4-10 weeks pregnant (gestation)
<br>
<br> Exclusion Criteria:
<br>
<br> - Male (biologically unable to achieve pregnancy)
<br> | | Corona Virus Infection;COVID;Pregnancy Related;Early Pregnancy | | Incidence of SARS-CoV-2 infection throughout pregnancy in women;Prevalence of SARS-CoV-2 infection throughout pregnancy in women→Prevalence of SARS-CoV-2 infection throughout pregnancy in women;Incidence of SARS-CoV-2 infection throughout pregnancy in women | | | | Yes | False | | |
| → | NCT04389671 | 27 September 2021→15 November 2021 | The Safety and Preliminary Tolerability of Lyophilized Lucinactant in Adults With Coronavirus Disease 2019 (COVID-19) | A Multicenter, Single-Treatment Study to Assess the Safety and Tolerability of Lyophilized Lucinactant in Adults With COVID-19 Associated Acute Lung Injury | | Windtree Therapeutics | 13/05/2020 | 20200513 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04389671 | Recruiting | No | 18 Years | 75 Years | All | November 2, 2020 | 20 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States→United States;Argentina;United States | ; → ; ; | Yuh-Chin T Huang, MD, MHS;Catherine Kacprzycki, BSN→Yuh-Chin T Huang, MD, MHS;Steve G Simonson, MD;Catherine Kacprzycki, BSN | | ;ckacprzycki@windtreetx.com→;;ckacprzycki@windtreetx.com | ;215-488-9478→;;215-488-9478 | Duke University;→Duke University;Windtree Therapeutics; |
<br> Inclusion Criteria:
<br>
<br> - Signed and dated informed consent form (ICF) by the subject or legally authorized
<br> representative;
<br>
<br> - Age 18-75 (inclusive);
<br>
<br> - Assay positive for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) virus,
<br> preferably by polymerase chain reaction (PCR);
<br>
<br> - Endotracheal intubation and mechanical ventilation (MV), within 7 days of initial
<br> intubation;
<br>
<br> - In-dwelling arterial line;
<br>
<br> - P/F ratio < 300;
<br>
<br> - Mean blood pressure = 65 mmHg, immediately before enrollment;
<br>
<br> - Bilateral infiltrates seen on frontal chest radiograph.
<br>
<br> Exclusion Criteria:
<br>
<br> - Life expectancy < 48 hours or do not resuscitate orders;
<br>
<br> - Severe lung disease (home O2, forced expiratory volume at one second [FEV1] < 2
<br> liters) not likely to respond to therapy or profound hypoxemia (ie, OI = 25 or P/F <
<br> 100);
<br>
<br> - Severe renal impairment (creatinine clearance < 30 mL/min);
<br>
<br> - Within the last 6 months has received, or is currently receiving, immunosuppression
<br> therapy (azathioprine, cyclophosphamide or methotrexate) or any transplant recipient;
<br>
<br> - Clinically significant cardiac disease that adversely effects cardiopulmonary
<br> function:
<br>
<br> 1. Acute coronary syndromes or active ischemic heart disease (as assessed by the PI
<br> using troponin and ECG)
<br>
<br> 2. Cardiac ejection fraction < 40% (if known);
<br>
<br> 3. Need for multiple-dose vasopressors to support blood pressure (single dose
<br> vasopressors, such as Levophed™ = 0.1 mcg/kg/min are allowed);
<br>
<br> 4. Cardiogenic pulmonary edema as the etiology of the current respiratory distress;
<br>
<br> 5. Evidence of myocarditis or pericarditis;
<br>
<br> - Neuromuscular disease;
<br>
<br> - Neutropenia (ANC < 1000);
<br>
<br> - Active malignancy that impacts treatment decisions or life expectancy related to the
<br> trial;
<br>
<br> - Suspected concomitant bacterial or other viral lung infection. Bacterial infection
<br> defined as white blood count (WBC) > 15k and positive blood/urine/sputum culture
<br> results within 72 hours.
<br> | | COVID-19;Acute Lung Injury/Acute Respiratory Distress Syndrome (ARDS) | Drug: Lucinactant | Oxygen index (OI);Evaluate the safety and feasibility of Lucinactant surfactant replacement therapy (SRT) in treating COVID-19→Evaluate the safety and feasibility of Lucinactant surfactant replacement therapy (SRT) in treating COVID-19;Oxygen index (OI) | | | | Yes | False | | |
| → | NCT04392323 | 12 December 2020→15 November 2021 | Incidence of COVID-19 Test Conversion in Post-surgical Patients | Incidence of COVID-19 Test Conversion in Post-surgical Patients | | Northwell Health | 15/05/2020 | 20200515 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04392323 | Recruiting→Not recruiting | No | 18 Years | N/A | All | May 13, 2020 | 500→111 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Diagnostic. Masking: None (Open Label). | N/A | United States | ; ; → ; | Ernesto Molmenti, MD, PhD, MBA;Aaron Nizam, MD;Aaron Nizam, MD→Ernesto Molmenti, MD, PhD, MBA;Aaron Nizam, MD | | ;;anizam1@northwell.edu→; | ;;9179570305→; | Northwell Health;Northwell Health;→Northwell Health;Northwell Health |
<br> Inclusion Criteria:
<br>
<br> 1. Patients of any ethnic background undergoing an elective surgical procedure with a
<br> minimum of 24-hour hospital admission.
<br>
<br> 2. Age =18.
<br>
<br> 3. Written Voluntary Informed Consent.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients age < 18 years.
<br>
<br> 2. Prior documented COVID-19 Infection.
<br>
<br> 3. Current hospital inpatient prior to procedure.
<br>
<br> 4. Person Under Investigation for COVID-19 infection.
<br>
<br> 5. Current use of antiviral medications.
<br>
<br> 6. Severe or uncontrolled, concurrent medical disease (e.g. uncontrolled diabetes,
<br> unstable angina, myocardial infarction within 6 months, congestive heart failure,
<br> etc.) .
<br>
<br> 7. Documented immunodeficiency.
<br>
<br> 8. Patients with dementia or altered mental status that would prohibit the giving and
<br> understanding of informed consent at the time of study entry.
<br>
<br> 9. Outpatient procedures with planned same-day discharge.
<br> | | Sars-CoV2 | Diagnostic Test: COVID-19 PCR and Serology | COVID-19 Test Conversion | | | | Yes | False | | |
| → | NCT04395508 | 11 October 2021→15 November 2021 | An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic | An Expanded Access, Single-Arm, Multicenter Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic | | Genentech, Inc. | 15/05/2020 | 20200515 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04395508 | Not recruiting | No | 18 Years | N/A | All | May 18, 2021→May 15, 2020 | | Expanded Access | | | United States | ; | Clinical Trials;Reference Study ID Number: AL42478 www.roche.com/about_roche/roche_worldwide.htm→Clinical Trials;Reference Study ID Number: AL42478 https://forpatients.roche.com/ | | ;global-roche-genentech-trials@gene.com | ;888-662-6728 (U.S. only) | Genentech, Inc.; |
<br> Inclusion Criteria:
<br>
<br> - Female or male patients with histologically confirmed human epidermal growth factor
<br> receptor 2-positive (HER2+) breast cancer who have completed chemotherapy in
<br> combination with P+H IV and are currently receiving or will be receiving maintenance
<br> P+H IV, PH FDC SC, or trastuzumab SC (regardless of remaining treatment cycles [e.g.,
<br> only 1 cycle remaining])
<br>
<br> - HER2+ status must have been previously determined and is defined as 3+ by
<br> immunohistochemistry (IHC) and/or positive by HER2 amplification by in situ
<br> hybridization (ISH) with a ratio of =2 for the number of HER2 gene copies to the
<br> number of chromosome 17 copies
<br>
<br> - Eastern Cooperative Oncology Group (ECOG) performance status 0-2
<br>
<br> - Intact skin at planned site of subcutaneous (SC) injections (thigh)
<br>
<br> - Baseline and most recent (within 3 months) LVEF = 50% measured by echocardiogram
<br> (ECHO) or multiple-gated acquisition scan (MUGA)
<br>
<br> - For women of childbearing potential: agreement to remain abstinent (refrain from
<br> heterosexual intercourse) or use contraceptive measures, and agreement to refrain from
<br> donating eggs, as defined in the protocol
<br>
<br> - For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use
<br> a condom, and agreement to refrain from donating sperm, as defined in the protocol
<br>
<br> Exclusion Criteria:
<br>
<br> - Current or prior history of active malignancy (other than current breast cancer)
<br> within the last 5 years. Appropriately treated non-melanoma skin cancer; in situ
<br> carcinomas, including cervix, colon, or skin; or Stage I uterine cancer within the
<br> last 5 years are allowed
<br>
<br> - Investigational treatment within 4 weeks of enrollment
<br>
<br> - Patients with any severe infection within 4 weeks prior to initiation of study
<br> treatment, including, but not limited to, hospitalization for complications of
<br> infections should not be enrolled in the trial (in the current situation, this also
<br> applies to patients with suspected or confirmed COVID-19 infection). Patients with
<br> suspected or confirmed COVID-19 may be re-screened for eligibility following
<br> physician-prescribed COVID-19 treatment and/or quarantine and following a negative
<br> COVID-19 real-time reverse transcription polymerase chain reaction (rRT-PCR) test
<br>
<br> - Patients who may have had a recent episode of thromboembolism and are still trying to
<br> optimize the anticoagulation dose and/or have not normalized their INR
<br>
<br> - Serious cardiac illness or medical conditions
<br>
<br> - History of ventricular dysrhythmias or risk factors for ventricular dysrhythmias, such
<br> as structural heart disease (e.g., severe left ventricular systolic dysfunction
<br> [LVSD], left ventricular hypertrophy), coronary heart disease (symptomatic or with
<br> ischemia demonstrated by diagnostic testing), clinically significant electrolyte
<br> abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of
<br> sudden unexplained death or long QT syndrome
<br>
<br> - Inadequate bone marrow function
<br>
<br> - Impaired liver function
<br>
<br> - Renal function with creatinine clearance <50 mL/min using the Cockroft-Gault formula
<br>
<br> - Major surgical procedure unrelated to breast cancer within 28 days prior to study
<br> entry or anticipation of the need for major surgery during the course of study
<br> treatment
<br>
<br> - Current severe, uncontrolled systemic disease that may interfere with planned
<br> treatment (e.g., clinically significant cardiovascular, pulmonary, or metabolic
<br> disease; wound-healing disorders)
<br>
<br> - Pregnant or breastfeeding, or intending to become pregnant during the study or within
<br> seven months after the last dose of study treatment
<br>
<br> - Any serious medical condition or abnormality in clinical laboratory tests that, in the
<br> investigator's judgment, precludes the patient's safe participation in, and completion
<br> of, the study
<br>
<br> - Known active liver disease, for example, active viral hepatitis infection (i.e.,
<br> hepatitis B or hepatitis C), autoimmune hepatic disorders, or sclerosing cholangitis
<br>
<br> - Concurrent, serious, uncontrolled infections, or known infection with human
<br> immunodeficiency virus (HIV)
<br>
<br> - Known hypersensitivity to any of the study drugs, excipients, and/or murine proteins
<br> or a history of severe allergic or immunological reactions, e.g. difficult to control
<br> asthma
<br>
<br> - Previously experienced severe injection related reactions with P+H IV, PH FDC SC,
<br> and/or trastuzumab SC
<br>
<br> - Current chronic daily treatment with corticosteroids (dose >10 mg methylprednisolone
<br> or equivalent excluding inhaled steroids)
<br> | | HER2-positive Breast Cancer | Drug: Pertuzumab and Trastuzumab Fixed-Dose Combination for Subcutaneous Administration (PH FDC SC) | | | | | Yes | False | | |
| → | NCT04400799 | 27 September 2021→15 November 2021 | Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With COVID-19 | Enoxaparin for Primary Thromboprophylaxis in Ambulatory Patients With Coronavirus: The Multicenter Randomized Controlled Ovid Trial | | University of Zurich | 15/05/2020 | 20200515 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04400799 | Recruiting | Yes | 50 Years | N/A | All | June 15, 2020 | 1000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | Germany;Switzerland;Germany;Switzerland | ; | Nils Kucher, Prof.;Stefano Barco, MD, PhD | | ;stefano.barco@usz.ch | ;+41432531150 | University of Zurich; |
<br> Inclusion Criteria:
<br>
<br> 1. Patients aged 50 years or older with a positive test for SARS-CoV2 in the past 5 days
<br> and eligible for ambulatory treatment.
<br>
<br> 2. Presence of respiratory symptoms (i.e. cough, sore throat, or shortness of breath) or
<br> body temperature >37.5° C.
<br>
<br> 3. Ability of the patient to travel to the study center by private transportation,
<br> performed either by accompanying person from same household or by the patient
<br> him/herself
<br>
<br> 4. Ability to comply with standard hygiene requirements at the time of in-hospital visit,
<br> including a face mask and hand disinfectant.
<br>
<br> 5. Ability to walk from car to study center or reach it using a wheel chair transport
<br> with the help of an accompanying person from the same household also complying with
<br> standard hygiene requirements.
<br>
<br> 6. Ability to self-administer prefilled enoxaparin injections after instructions received
<br> at the study center or availability of a person living with the patient to administer
<br> enoxaparin.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Any acute or chronic condition posing an indication for anticoagulant treatment, e.g.
<br> atrial fibrillation, prior VTE, acute confirmed symptomatic VTE, acute coronary
<br> syndrome.
<br>
<br> 2. Anticoagulant thromboprophylaxis deemed necessary in view of the patient's history,
<br> comorbidity or predisposing strong risk factors for thrombosis:
<br>
<br> 1. Any of the following events occurring in the prior 30 days: fracture of lower
<br> limb, hospitalization for heart failure, hip/knee replacement, major trauma,
<br> spinal cord injury, stroke,
<br>
<br> 2. previous VTE,
<br>
<br> 3. histologically confirmed malignancy, which was diagnosed or treated (surgery,
<br> chemotherapy, radiotherapy) in the past 6 months, or recurrent, or metastatic, or
<br> inoperable.
<br>
<br> 3. Any clinically relevant bleeding (defined as bleeding requiring hospitalization,
<br> transfusion, surgical intervention, invasive procedures, occurring in a critical
<br> anatomical site, or causing disability) within 30 days prior to randomization or sign
<br> of acute bleeding.
<br>
<br> 4. Intracerebral bleeding at any time in the past or signs/symptoms consistent with acute
<br> intracranial hemorrhage.
<br>
<br> 5. Hemoglobin <8 g/dL and platelet count <50 x 109 cells/L confirmed by recent laboratory
<br> test (<90 days).
<br>
<br> 6. Subjects with any known coagulopathy or bleeding diathesis, including known
<br> significant liver disease associated with coagulopathy.
<br>
<br> 7. Severe renal insufficiency (baseline creatinine clearance <30 mL/min calculated using
<br> the Cockcroft-Gault formula) confirmed by recent laboratory test (<90 days).
<br>
<br> 8. Contraindications to enoxaparin therapy, including prior heparin-induced
<br> thrombocytopenia and known hypersensitivity.
<br>
<br> 9. Current use of dual antiplatelet therapy.
<br>
<br> 10. Participation in other interventional studies over the past 30 days.
<br>
<br> 11. Non-compliance or inability to adhere to treatment or lack of a family environment or
<br> support system for home treatment.
<br> | | COVID-19;Pulmonary Embolism, Deep Vein Thrombosis | Drug: Enoxaparin 40Mg/0.4Ml Inj Syringe 0.4Ml | all-cause death;hospitalizations | | | | Yes | True | parent | |
| → | NCT04401371 | 8 February 2021→15 November 2021 | Distance Learning for Dental Student During COVID-19 Pandemic→Distance and Hybrid Learning for Dental Student During COVID-19 Pandemic | Assessment of Dental Students Opinion About Distance Education Learning Environment During COVID-19 Pandemic (Cross-Sectional Study)→Comparative Evaluation of the Learning Environment of Pediatric Dentistry Course Through Hybrid Learning Versus Distance Learning | | Cairo University | 21/05/2020 | 20200521 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04401371 | Not recruiting | No | N/A | N/A | All | May 1, 2020 | 418→376 | Observational | | | Egypt | | Maha Moussa→Yasmin Mohamed | | | | Fayoum University→Cairo University |
<br> Inclusion Criteria:
<br>
<br> - all 5th year dental student enrolled in pediatric dentistry online course in both
<br> universities was invited to participate
<br>
<br> Exclusion Criteria:
<br>
<br> - incomplete questionnaire
<br> →
<br> Inclusion Criteria:
<br>
<br> - all 5th year dental student enrolled in pediatric dentistry hybrid and distance course
<br> in Cairo university was invited to participate
<br>
<br> Exclusion Criteria:
<br>
<br> - incomplete questionnaire
<br> | | Distance Education Learning Environment During COVID 19 Pandemic→Education During COVID 19 Pandemic | | assessment of distance education learning environment experiences among dental students enrolled in pediatric dentistry online course during COVID-19 crisis→Comparative evaluation of education learning environment experiences among dental students enrolled in pediatric dentistry course in hybrid versus distance learning during COVID-19 crisis | | | | Yes | False | | |
| → | NCT04401410 | 12 April 2021→15 November 2021 | Anti-SARS Cov-2 T Cell Infusions for COVID 19 | BAT IT: Banked Anti-SARS Cov-2 T Cell Infusions for Treatment of COVID 19 | BATIT | Baylor College of Medicine | 21/05/2020 | 20200521 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04401410 | Recruiting→Not recruiting | No | 18 Years | N/A | All | November 4, 2020 | 58 | Interventional | Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | United States | ; ; → | Premal Lulla;Premal Lulla, MD;Premal Lulla, MD→Premal Lulla | | ;lulla@bcm.edu;lulla@bcm.edu→ | ;832-824-4847;832-824-4847→ | Baylor College of Medicine;→Baylor College of Medicine |
<br> Inclusion Criteria
<br>
<br> 1. SARS-CoV-2 infection confirmed by polymerase chain reaction assay (PCR) from a
<br> nasopharyngeal swab or other accepted specimen type. (If testing was performed = 5
<br> days before enrollment, this must be repeated and accept only if positive again). Date
<br> of COVID test must be = 5 days prior to infusion.
<br>
<br> 2. Currently hospitalized adult patient (= 18 years of age) requiring medical care for
<br> COVID19
<br>
<br> 3. Peripheral oxygen saturation (SpO2) = 92% on room air
<br>
<br> 4. Hgb = 7.0 gm/dl
<br>
<br> 5. Negative pregnancy test (if applicable)
<br>
<br> 6. Patient or parent/guardian capable of providing informed consent (may be obtained
<br> electronically)
<br>
<br> 7. Evidence of pulmonary infiltrates on chest imaging. Any chest imaging findings which
<br> would be consistent with COVID19 would qualify (Eg: ground glass opacities, multifocal
<br> infiltrates etc.)
<br>
<br> 8. High risk of requiring mechanical ventilation as defined by at least two of the
<br> following:
<br>
<br> 1. Age = 60 years of age
<br>
<br> 2. Age = 75 years of age (counts as meeting two criteria)
<br>
<br> 3. Hypertension (HTN)
<br>
<br> 4. Chronic cardiovascular disease other than HTN (eg: Coronary artery disease,
<br> congestive heart failure or cardiomyopathies).
<br>
<br> 5. Diabetes Mellitus
<br>
<br> 6. Obesity (BMI = 30)
<br>
<br> 7. Obesity (BMI = 40, counts as meeting two criteria)
<br>
<br> 8. Active cancer diagnosis or ongoing (within 3 months) cytotoxic chemo/
<br> radio-therapy for a cancer
<br>
<br> 9. Post-hematopoeitic stem cell or solid organ transplantation status
<br>
<br> 10. Immunodeficiency states including HIV infection on antiretroviral therapy (except
<br> those listed as exclusion criteria #1, #7 and #10) as determined by the treating
<br> physician (eg: receiving immunosuppressive therapy like rituximab or congenital
<br> immunodeficiency syndromes, prior treatment with chemotherapy greater than 3
<br> months ago but per investigators discretion could have lingering effects on the
<br> immune system, eg: chemotherapy regimens for lymphomas, ALL or AML etc.)
<br>
<br> 11. Chronic obstructive pulmonary disease (COPD)
<br>
<br> 12. Current everyday smoker
<br>
<br> 13. Chronic kidney disease (eGFR < 30 mL/min/1.73 m2 )
<br>
<br> 14. Bronchial asthma (on active treatment prior to admission, eg. Use of rescue
<br> inhalers or inhaled corticosteroids or other treatments to prevent/treat
<br> attacks).
<br>
<br> Exclusion Criteria
<br>
<br> 1. Received Anti-thymocyte globulin (ATG), Campath or other T cell immunosuppressive
<br> monoclonal antibodies in the 28 days prior to screening for enrollment
<br>
<br> 2. Requiring mechanical ventilation at time of T cell infusion
<br>
<br> 3. Alanine aminotransferase or aspartate aminotransferase greater than 5 x upper limit of
<br> normal
<br>
<br> 4. If previously undergone an allogeneic hematopoietic stem cell transplant and have
<br> evidence of active acute GVHD greater than or equal to grade 2
<br>
<br> 5. Uncontrolled relapse of malignancy
<br>
<br> 6. Requiring vasopressors
<br>
<br> 7. Known history of autoimmune disease except prior thyroiditis
<br>
<br> 8. Is not suitable at the discretion of the treating physician
<br>
<br> 9. Patients on greater than 6mg/day of dexamethasone (IV) or equivalent
<br>
<br> 10. Greater than grade 1 CRS per American Society for Transplantation and Cellular Therapy
<br> (ASTCT) criteria
<br>
<br> 11. Patients should not be enrolled on any other interventional clinical trials for
<br> COVID19. Patients may receive routine care for COVID19 per institutional standards
<br> (including antivirals such as remdesivir or other FDA-EUA approved products and
<br> thromboprophylaxis).
<br> | | SARS-CoV 2;Viral Infection;COVID 19 | Biological: Dose Finding Phase (MTD);Biological: Partially HLA-matched SARS-CoVSTs;Other: Routine care (no SARS-CoVSTs) | Dose Escalation Phase: Rate of Dose Limiting Toxicities by CTCAE 5.0 [14 days post infusion];Randomized Trial: Rate of Clinical Response as assessed by the World Health Organization (WHO) Ordinal Scale [7 days post-randomization or hospital discharge] | | | | Yes | False | | |
| → | NCT04407143 | 16 February 2021→15 November 2021 | Study of the Immunity of Patients With Lung Cancer and COVID-19 Infection | Study of Acquired Immunity in Patients With Lung Cancer and COVID-19 Infection | SOLID | Fundación GECP | 25/05/2020 | 20200525 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04407143 | Recruiting→Not recruiting | No | 18 Years | N/A | All | April 15, 2020 | 128→1980 | Observational | | | Spain | ; → | Mariano Provencio, MD;Eva Pereira→Mariano Provencio, MD | | ;epereira@gecp.org→ | ;+34934302006→ | Hospital Puerta de Hierro de Majadahonda de Madrid;→Hospital Puerta de Hierro de Majadahonda de Madrid |
<br> Inclusion Criteria:
<br>
<br> 1. Patients diagnosed with lung cancer at any stage of the disease
<br>
<br> 2. Age = 18
<br>
<br> 3. Patients who have signed the informed consent for this study
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients who have not signed or do not wish to sign the informed consent for this study
<br> | | Lung Cancer;COVID;Corona Virus Infection | Diagnostic Test: IgG test | Description of the characteristics of patients | | | | Yes | False | | |
| → | NCT04409743 | 17 May 2021→15 November 2021 | Brief Telehealth CBT-I Intervention in the Context of the COVID-19 Pandemic | Harnessing Telehealth to Mitigate the Impact of the COVID-19 Pandemic on Sleep, Suicidality, and Neuropsychiatric Symptoms | | Stanford University | 28/05/2020 | 20200528 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04409743 | Not recruiting | No | 18 Years | N/A | All | June 7, 2020 | 49 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant). | N/A | United States | | Andrea Goldstein-Piekarski, PhD | | | | Stanford University |
<br> Inclusion Criteria:
<br>
<br> - Age 18 years or older
<br>
<br> - Access to the internet
<br>
<br> - Subjective complaint of sleep disturbance (ISI =10) that began after March 1, 2020 or
<br> the COVID-19 Pandemic (self-reported during DUKE Interview)
<br>
<br> - Lives in the United States
<br>
<br> Exclusion Criteria:
<br>
<br> - Presence of suicidal ideation representing high risk as measured by the
<br> Sheehan-Suicide Tracking Scale (S-STS).
<br>
<br> - Use of medication specifically prescribed for sleep disturbance and unwilling or
<br> unable to discontinue more than one week prior to baseline data collection.
<br>
<br> - Current or lifetime history of bipolar disorder or psychosis
<br>
<br> - Current substance abuse or dependence
<br>
<br> - Not able to verbalize understanding of involvement in research and provide written,
<br> informed consent
<br>
<br> - Not fluent or literate in English
<br>
<br> - Unstable pharmacotherapy for other mental health disorders
<br>
<br> - Severe impediment to vision, hearing, and/or hand movement, likely to interfere with
<br> the ability to complete assessments, or are unable and/or unlikely to follow study
<br> protocols
<br>
<br> - Working rotating shift that overlaps with 2400h
<br> | | Sleep Disturbance;Insomnia | Behavioral: Remote Cognitive Behavioral Therapy for Insomnia | Change in International Physical Activity Questionnaire (IPAQ) Scale Score Over Time;Change in Screen Time- Self Report Over Time;Change in Perceived Stress Scale Score Over Time;Change in Social Network Index (SNI) Scale Score Over Time;Change in UCLA Loneliness Scale Score Over Time;Change in Sheehan Suicidality Tracking Scale (S-STS) Score Over Time;Change in Quality of Life (SF-36) Scale Score Over Time;Change in Insomnia Severity Index (ISI) Scale Score Over Time;Change in Generalized Anxiety Disorder-7 (GAD-7) Scale Score Over Time;Change in Patient Health Questionnaire-9 (PHQ-9) Scale Score as a Measure of Depression Symptoms Over Time;Change in Insomnia Clinical Diagnosis Over Time→Change in Insomnia Clinical Diagnosis Over Time;Change in Patient Health Questionnaire-9 (PHQ-9) Scale Score as a Measure of Depression Symptoms Over Time;Change in Generalized Anxiety Disorder-7 (GAD-7) Scale Score Over Time;Change in Insomnia Severity Index (ISI) Scale Score Over Time;Change in Quality of Life (SF-36) Scale Score Over Time;Change in Sheehan Suicidality Tracking Scale (S-STS) Score Over Time;Change in UCLA Loneliness Scale Score Over Time;Change in Social Network Index (SNI) Scale Score Over Time;Change in Perceived Stress Scale Score Over Time;Change in Screen Time- Self Report Over Time;Change in International Physical Activity Questionnaire (IPAQ) Scale Score Over Time | | | | Yes | False | | |
| → | NCT04411628 | 12 December 2020→15 November 2021 | A Study of LY3819253 (LY-CoV555) in Participants Hospitalized for COVID-19 | A Randomized, Placebo-Controlled, Double-Blind, Sponsor Unblinded, Single Ascending Dose, Phase 1 First in Human Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Intravenous LY3819253 in Participants Hospitalized for COVID-19 | | Eli Lilly and Company | 29/05/2020 | 20200529 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04411628 | Not recruiting | No | 18 Years | 75 Years | All | May 28, 2020 | 24→26 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Basic Science. Masking: Double (Participant, Investigator). | Phase 1 | United States | | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | | | | Eli Lilly and Company |
<br> Inclusion Criteria:
<br>
<br> - Are hospitalized or in the process of being admitted to hospital and have an initial
<br> laboratory determination of current COVID-19 infection less than or equal to (=)72
<br> hours prior to randomization
<br>
<br> - Are men or non-pregnant women
<br>
<br> - Women of childbearing potential must agree to use at least one highly effective form
<br> of contraception for the entirety of the study
<br>
<br> - Agree to the collection of nasopharyngeal swabs and venous blood
<br>
<br> Exclusion Criteria:
<br>
<br> - Require mechanical ventilation or anticipated impending need for mechanical
<br> ventilation
<br>
<br> - Received convalescent COVID-19 plasma treatment prior to enrollment
<br>
<br> - Were resident in a nursing home or long-term care facility immediately prior to
<br> current hospitalization
<br>
<br> - Suspected or proven serious, active bacterial, fungal, viral, or other infection
<br> (besides COVID-19) that in the opinion of the investigator could constitute a risk
<br> when taking investigational product
<br>
<br> - Have an oxygen saturation (SpO2) less than (<)88 percent (%) while breathing room air
<br> at rest at randomization.
<br> | | COVID-19 | Drug: LY3819253;Drug: Placebo | Number of Participants with One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration→Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration | →09/11/2021 | | →https://clinicaltrials.gov/ct2/show/results/NCT04411628 | Yes | False | | →Yes |
| → | NCT04412395 | 13 September 2021→15 November 2021 | Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory in Treating COVID-19 Disease | Clinical Assessment of Oral Lactoferrin as a Safe Antiviral and Immunoregulatory Therapy in Patients Diagnosed With COVID-19 Disease | COVID-19_LF | National Research Centre, Egypt | 15/05/2020 | 20200515 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04412395 | Not recruiting | No | 18 Years | 80 Years | All | October 1, 2021→February 1, 2022 | 516 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | Egypt | ; | Rehab Hegazy, PhD;Rehab Hegazy, PhD | | ;rehab_hegazy@hotmail.com | ;+201001507676 | National Research Center; |
<br> Inclusion Criteria:
<br>
<br> - Patients tested positive (PCR) for SARS-CoV-2 and clinically symptomatic.
<br>
<br> - Adult patients with age >18 years.
<br>
<br> - Patients willing and able to sign the study informed consent form.
<br>
<br> Exclusion Criteria:
<br>
<br> - Critically severe disease patients (having Respiratory failure requiring mechanical
<br> ventilation, or signs of septic shock or multiple organ failure requiring ICU
<br> admission).
<br>
<br> - Patients who are unconscious
<br>
<br> - Patients who have convulsions
<br>
<br> - Patients suffering from central cyanosis with SPO2< 90% (for asthmatic patients with
<br> SPO2<88%)
<br>
<br> - Pregnant or lactating women
<br>
<br> - Patients with a known history of pro-inflammatory diseases (patients with autoimmune
<br> diseases, patients receiving chemotherapy for cancer, patients with malabsorption,
<br> patients with inflammatory bowel disease, Crohn's disease or ulcerative colitis).
<br>
<br> - History or suspected immunosuppressive or immunodeficient state including HIV
<br> infection, or chronic immunosuppressant medication (more than 14 days) within the past
<br> 3 months (inhaled and topical steroids are allowed).
<br>
<br> - Patients with severe renal impairment (GFR <60 ml/min/1.73m2 as measured by the
<br> Cockcroft-Gault formula).
<br>
<br> - Patient with severe hepatic impairment, biliary cirrhosis or cholestasis
<br>
<br> - Patients who received immunoregulatory therapy within one month before the start of
<br> the study.
<br>
<br> - Patients with Known or suspected allergy or any contraindications to Lactoferrin.
<br>
<br> - Any condition, according to the judgment of the investigator, would interfere with the
<br> patient's ability to comply with all study requirements or that would place the
<br> patient at unacceptable risk by his/her participation in the study.
<br> | | Corona Virus Infection;Middle East Respiratory Syndrome (MERS);Acute Respiratory Distress Syndrome;Coronavirus Infection;COVID-19;SARS-CoV 2 | Dietary Supplement: Lactoferrin (Apolactoferrin);Drug: Placebo of excipient(s) will be administered | The number of patients with PCR negative results.;Rate of disease remission.;Survival rate.→Survival rate.;Rate of disease remission.;The number of patients with PCR negative results. | | | | Yes | False | | |
| → | NCT04414631 | 30 August 2021→15 November 2021 | Conestat Alfa in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19 | Recombinant Human C1 Esterase Inhibitor (Conestat Alfa) in the Prevention of Severe SARS-CoV-2 Infection in Hospitalized Patients With COVID-19: a Randomized, Parallel-group, Open-label, Multi-center Pilot Trial (PROTECT-COVID-19). | | University Hospital, Basel, Switzerland | 19/05/2020 | 20200519 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04414631 | Not recruiting | No | 18 Years | 85 Years | All | August 6, 2020 | 120→80 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | Brazil;Switzerland;Mexico;Brazil;Switzerland;Mexico→Brazil;Mexico;Switzerland;Brazil;Mexico;Switzerland | | Michael Osthoff, PD Dr. med. | | | | University Hospital Basel, Division of Internal Medicine |
<br> Inclusion Criteria:
<br>
<br> - Informed Consent as documented by signature
<br>
<br> - admitted to the hospital because of confirmed (by a positive SARS-CoV-2 PCR result)
<br> COVID-19 infection
<br>
<br> - evidence of pulmonary involvement on CT scan or X-ray of the chest (e.g. ground glass
<br> opacities)
<br>
<br> - symptom onset within the previous 10 days OR shortness of breath within the previous 5
<br> days. Symptoms include fever or one respiratory symptom (patients presenting later may
<br> have already progressed to an inflammatory state that is potentially not amenable to
<br> C1INH treatment). Respiratory symptoms include cough, sore throat, hemoptysis,
<br> shortness of breath, runny nose, or chest pain.
<br>
<br> - expected to remain an inpatient over the next three calender days from time of
<br> enrolment
<br>
<br> - at least one additional risk factor for progression to mechanical ventilation: 1)
<br> arterial hypertension, 2) >50 years, 3) obesity (BMI>30.0 kg/m2), 4) cardiovascular
<br> disease, 5) chronic pulmonary disease, 7) chronic renal disease, 6) C-reactive protein
<br> of >35mg/L, 7) oxygen saturation at rest in ambient air of <94%. Cardiovascular
<br> disease includes a history of coronary artery disease, cerebrovascular disease,
<br> peripheral artery disease, rheumatic heart disease, congenital heart disease and of
<br> recent (< 3 months) deep vein thrombosis or pulmonary embolism. Chronic pulmonary
<br> disease includes a history of chronic obstructive pulmonary disease, asthma,
<br> occupational lung disease, interstitial lung disease or of pulmonary hypertension.
<br> Chronic renal disease is defined as a history of an estimated glomerular filtration
<br> rate (according to the Chronic Kidney Disease Epidemiology Collaboration equation) <
<br> 60ml/min/1.73 m2 for at least three months.
<br>
<br> Exclusion Criteria:
<br>
<br> - Contraindications to the class of drugs under study (C1 esterase inhibitor), e.g.
<br> known hypersensitivity or allergy to class of drugs or the investigational product
<br>
<br> - Treatment with tocilizumab or another Il-6R or Il-6 inhibitor before enrolment
<br>
<br> - History or suspicion of allergy to rabbits
<br>
<br> - Women who are pregnant or breast feeding
<br>
<br> - Active or planned treatment with any other complement inhibitor
<br>
<br> - Liver cirrhosis (any Child-Pugh score)
<br>
<br> - Incapacity or inability to provide informed consent
<br>
<br> - Currently admitted to an ICU or expected admission within the next 24 hours
<br>
<br> - Currently receiving invasive or non-invasive ventilation (with the exception of
<br> high-flow oxygen therapy).
<br>
<br> - In the opinion of the treating time, death is deemed to be imminent and inevitable
<br> within the next 24 hours
<br>
<br> - Participation in another study with investigational drug within the 30 days preceding
<br> and during the present study with the following exemptions: 1) participation in
<br> COVID-19 drug trials started at least 48 hours before admission (e.g. postexposure
<br> prophylaxis with hydroxychloroquine) and 2) participation in COVID-19 drug trials
<br> during ICU admission
<br>
<br> - Previous enrolment into the current study
<br>
<br> - Enrolment of the investigator, his/her family members, employees and other dependent
<br> persons
<br>
<br> - Any uncontrolled or significant concurrent illness that would put the patient at a
<br> greater risk or limit compliance with the study requirements
<br> | | Coronavirus Infections | Drug: Conestat alfa | Disease severity | | | | Yes | False | | |
| → | NCT04418609 | 12 December 2020→15 November 2021 | Neuro-COVID-19: Neurological Complications of COVID-19 | Neuro-COVID-19: Neurological Complications of COVID-19 | Neuro-COVID | Emanuela Keller | 28/05/2020 | 20200528 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04418609 | Recruiting | No | 18 Years | N/A | All | May 1, 2020 | 30 | Observational | | | Switzerland | ; ; | Emanuela Keller, Prof. Dr.;Emanuela Keller, Prof. Dr.;Emanuela Keller, Prof. Dr. | | ;emanuela.keller@usz.ch; | ;0041 44 255 56 71; | University Hospital, Zürich; |
<br> Inclusion Criteria:
<br>
<br> - Adults (age > 18 years old) treated at ICUs
<br>
<br> - Admitted with confirmed COVID-19 infection
<br>
<br> - Patient exhibiting acute neurological manifestations
<br>
<br> - General consent of the Institute of Intensive Care Medicine available from patient or
<br> legal representative
<br>
<br> Exclusion Criteria:
<br>
<br> - Pre-existing severe neurologic dysfunction
<br> | | Neurologic Complication | Other: further processing of health data | Prevalence of neurological complications;Brain for pathological changes and histopathological findings (if patient dies).;Characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF);Impact of neurological complications;Prevalence and outcome of severe neurological complications→Brain for pathological changes and histopathological findings (if patient dies).;Characteristic patterns in cerebral imaging and electroencephalography (EEG), as well as cerebrospinal fluid (CSF);Impact of neurological complications;Prevalence and outcome of severe neurological complications;Prevalence of neurological complications | | | | Yes | False | | |
| → | NCT04420637 | 29 March 2021→15 November 2021 | Impact of the Covid-19 Pandemic on Gastrointestinal and Liver Diseases | Impact of the Covid-19 Pandemic on Gastrointestinal and Liver Diseases | RetroCov | Medical University of Graz | 04/06/2020 | 20200604 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04420637 | Recruiting | No | N/A | N/A | All | June 15, 2020 | 1000 | Observational | | | Austria | | | | | | |
<br> Covid-19 infection treated within the KAGES (Steirische Krankenanstalten GesmBH = Styrian
<br> public hospitals)
<br> | | COVID | | liver disease | | | | Yes | False | | |
| → | NCT04426292 | 12 December 2020→15 November 2021 | SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel During the 2020 COVID-19 Outbreak | SARS-COV-2 Seroprevalence and Seroconversion Among Employees of the Universitair Ziekenhuis Brussel During the 2020 COVID-19 Outbreak | COVEMUZ | Universitair Ziekenhuis Brussel | 08/06/2020 | 20200608 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04426292 | Recruiting | No | 18 Years | N/A | All | May 12, 2020 | 3500 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label). | N/A | Belgium | ; | Sabine Allard, MD;Laurien De Greef, Nurse | | sabine.allard@uzbrussel.be;laurien.degreef@uzbrussel.be | 1923369;1929849 | |
<br> Inclusion Criteria:
<br>
<br> - Any adult employee of the UZ Brussel who provided a signed informed consent to
<br> participate in the study.
<br>
<br> Exclusion Criteria:
<br>
<br> - UZ Brussel employees whose contract expires within 6 months of study initiation, with
<br> the exception of resident trainees (if training continues in another hospital,
<br> resident trainees will be asked to perform the last sampling when leaving the UZ
<br> Brussel).
<br>
<br> - Staff not active during the inclusion period
<br> | | Sars-CoV2 | Diagnostic Test: Serological testing | Seroprevalence;seroconversions→seroconversions;Seroprevalence | | | | Yes | False | | |
| → | NCT04435184 | 25 January 2021→15 November 2021 | Crizanlizumab for Treating COVID-19 Vasculopathy | Crizanlizumab for Treating COVID-19 Vasculopathy | CRITICAL | Johns Hopkins University | 16/06/2020 | 20200616 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04435184 | Not recruiting | No | 18 Years | N/A | All | July 9, 2020 | 50→54 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | United States | | Charles J Lowenstein, MD | | | | Johns Hopkins University |
<br> Inclusion Criteria:
<br>
<br> 1. Willing to provide written informed consent
<br>
<br> 2. Willing to comply with all study procedures and be available for the duration of the
<br> study
<br>
<br> 3. Male or female = 18 years of age
<br>
<br> 4. SARS-CoV-2 infection (COVID-19) within the past 10 d documented by laboratory test
<br> (nucleic acid test (NAT) or reverse transcriptase-polymerase chain reaction (RT-PCR))
<br>
<br> 5. Currently hospitalized
<br>
<br> 6. Symptoms of acute respiratory infection (at least one of the following: cough, fever >
<br> 37.5°C, dyspnea, sore throat, anosmia),
<br>
<br> 7. Radiographic evidence of pulmonary infiltrates
<br>
<br> 8. Requiring supplemental oxygen or the peripheral capillary oxygenation saturation
<br> (SpO2) < 94% on room air at screening
<br>
<br> 9. Elevated D-Dimer > 0.49 mg/L
<br>
<br> 10. Negative pregnancy test for females of childbearing potential
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Use of home oxygen at baseline
<br>
<br> 2. Current use of mechanical ventilation
<br>
<br> 3. Inability to provide consent
<br>
<br> 4. Do not intubate status
<br>
<br> 5. Prisoner or incarcerated
<br>
<br> 6. Pregnancy or Breast Feeding
<br>
<br> 7. Participation in other interventional therapy trials for COVID-19.
<br>
<br> 8. International normalized ratio (INR) > 3 or activated partial thromboplastin time
<br> (aPTT) > 60
<br> | | COVID-19 | Drug: Crizanlizumab;Other: 0.9% saline | Soluble P-selectin level→Soluble P-selectin Level | →09/11/2021 | | →https://clinicaltrials.gov/ct2/show/results/NCT04435184 | Yes | False | | →Yes |
| → | NCT04435457 | 10 August 2021→15 November 2021 | Cardiovascular Implications of COVID-19 | Uncovering the Cardiac Phenotype of Individuals With SARS-COV-2 and Cardiac Injury | | University of Texas Southwestern Medical Center | 02/06/2020 | 20200602 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04435457 | Recruiting→Not recruiting | No | 18 Years | 80 Years | All | September 1, 2020 | 70 | Observational [Patient Registry] | | | United States | ; ; → | Justin L Grodin, MD, MPH;Carolyn Kelly, RN, MPH, CCRC;Carolyn Kelly, RN MPH→Justin L Grodin, MD, MPH | | ;Carolyn.Kelly@utsouthwestern.edu;Carolyn.Kelly@utsouthwestern.edu→ | ;214-645-8040;→ | UT Southwestern Medical Center at Dallas;→UT Southwestern Medical Center at Dallas |
<br> Inclusion Criteria:
<br>
<br> - Men and non-pregnant women 18-80 years old who were previously hospitalized with
<br> confirmed COVID-19
<br>
<br> - Were alive at the time of discharge from COVID-19 hospitalization
<br>
<br> - Had measured hs-cTnT levels during hospitalization
<br>
<br> Exclusion Criteria:
<br>
<br> - Prior cardiovascular disease (before COVID-19 infection), defined as self-reported
<br> history or electronic medical record diagnosis of cardiac arrest, myocardial
<br> infarction, coronary revascularization, heart failure, or stroke prior to COVID-19
<br> hospitalization
<br>
<br> - Urgent-coronary revascularization or type I myocardial infarction within the preceding
<br> 30 days
<br>
<br> - Cardiac transplantation
<br>
<br> - Body weight >250 lbs
<br>
<br> - Moderate to severe chronic renal dysfunction defined by an eGFR =30 mL/min/1.73 m2
<br>
<br> - Inability to safely undergo a CMR
<br>
<br> - Unwilling or unable to provide informed consent
<br> | | SARS-CoV 2;SARS Pneumonia;COVID-19;SARS-Associated Coronavirus as Cause of Disease Classified Elsewhere;Cardiac Complication | | Prevalence of Myocarditis | | | | Yes | False | | |
| → | NCT04440007 | 19 April 2021→15 November 2021 | Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized With COVID-19 | A Phase 2, Open Label, Randomized Study of the Efficacy and Safety of STI-5656 (Abivertinib Maleate) With Standard of Care Versus Standard of Care in Subjects Hospitalized With COVID-19 | SOC | Sorrento Therapeutics, Inc. | 17/06/2020 | 20200617 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04440007 | Not recruiting | No | 18 Years | N/A | All | October 9, 2020 | 80→92 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | | Mike Royal, MD JD | | | | Sorrento Therapeutics, Inc. |
<br> Inclusion Criteria:
<br>
<br> - Confirmed infection with SARS-CoV-2 per World Health Organization (WHO) criteria
<br> (including positive RT-PCR nucleic acid test of any specimen [eg, respiratory, blood,
<br> urine, stool, or other bodily fluid]) within 7 days of randomization
<br>
<br> - Hospitalized with COVID-19 pneumonia (documented radiographically) and oxygen
<br> saturation <94% on room air or subject requires supplemental oxygen
<br>
<br> - Able to swallow capsules
<br>
<br> - Willing to follow contraception guidelines
<br>
<br> - Subject or family member/caregiver must have provided written informed consent which
<br> includes signing the institutional review board approved consent form prior to
<br> participating in any study related activity. However, if obtaining written informed
<br> consent is not possible, other procedures as provided in the March 27th, 2020 FDA
<br> Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic,
<br> Question 10, may be used
<br>
<br> Exclusion Criteria:
<br>
<br> - Known cardio-pulmonary resuscitation within 14 days prior to randomization
<br>
<br> - Pregnant or breast feeding
<br>
<br> - Suspected uncontrolled active bacterial, fungal, viral, or other infection (besides
<br> infection with SARS-CoV-2)
<br>
<br> - Alanine aminotransferase (ALT) = 3x upper limit of normal (ULN) and total bilirubin >
<br> 2x ULN
<br>
<br> - QTcF prolongation >480 milliseconds
<br>
<br> - Uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the
<br> last 6 weeks, or congestive heart failure (NYHA Grade 3 or 4). Exception: Subjects
<br> with controlled, asymptomatic atrial fibrillation during screening are allowed to
<br> enroll
<br>
<br> - Treatment with a strong cytochrome P450 (CYP3A4 inhibitor (within 14 days before first
<br> dose of study drug) or inducer (within 7 days before first dose of study drug)
<br>
<br> - Received anti-rejection or immunomodulatory drugs (eg, anti-cytokines, BTK inhibitors,
<br> JAK inhibitors, PI3K inhibitors) within 30 days before randomization on study
<br>
<br> - Concurrent participation in another clinical trial involving therapeutic interventions
<br> (observational study participation is acceptable)
<br>
<br> - Any condition that confounds the ability to interpret data from the study
<br>
<br> - Relevant renal impairment (eGFR <60 mL/min)
<br>
<br> - Any significant medical condition, laboratory abnormality or psychiatric illness that
<br> would interfere or prevent the subject from participating in the study
<br> | | Covid-19 | Drug: Abivertinib;Other: Standard of Care | Proportion of subjects alive and free of respiratory failure at Day 28 | | | | Yes | False | | |
| → | NCT04457817 | 13 September 2021→15 November 2021 | Compensatory Reserve Index (CRI) for Management of COVID-19 | CRI and Continuous Assessment of Hemodynamic Compensation to Guide Fluid and Pressor Management in Severely Ill Patients With COVID-19 | | University of Colorado, Denver | 24/06/2020 | 20200624 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04457817 | Recruiting→Not recruiting | No | 18 Years | 70 Years | All | December 1, 2020 | 100→16 | Interventional→Observational | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). → | N/A→ | United States | | Steven L Moulton, MD | | | | Children's Hospital Colorado |
<br> Inclusion Criteria:
<br>
<br> Eligible patients will be those who are:
<br>
<br> - COVID-19 positive;
<br>
<br> - Ages > 18 and < 70 years old;
<br>
<br> - Require > 2 liters of oxygen by nasal cannula to maintain SpO2 > 90%;
<br>
<br> - Are admitted to the sixth floor at University Hospital, on one of two designated
<br> Hospitalist services (approximately 16 COVID-19 positive patients/service).
<br>
<br> Exclusion Criteria:
<br>
<br> - COVID-19 negative
<br>
<br> - Age <18 or >70 years
<br>
<br> - On <2 liters oxygen via nasal canula
<br>
<br> - Pregnant
<br>
<br> - Incarcerated
<br>
<br> - DNR/DNI
<br>
<br> - Decisionally Challenged
<br> | | COVID | Device: CRI management→Device: CRI | mortality;Number of patients with hemodynamic collapse;Number of Patients with Acute Kidney Injury (AKI);Number of participants with hospital acquired pneumonia;Days on Oxygen;FiO2 needs;Resuscitation status;Quantity of Blood pressure medication administered;Volume of IV fluid infused | | | | Yes | False | | |
| → | NCT04460677 | 21 July 2021→15 November 2021 | ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19 | ASD (Autism Spectrum Disorder) Telehealth for Distress Related to COVID-19 (Coronavirus Disease) | | Rutgers, The State University of New Jersey | 06/07/2020 | 20200706 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04460677 | Recruiting | No | 18 Years | N/A | All | August 12, 2020 | 80 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | United States | ; → | Vanessa Bal, PhD;Vanessa H Bal→ | | vanessa.bal@rutgers.edu;lifespanlab@rutgers.edu→ | 8484459384;848-445-9384→ | |
<br> Inclusion Criteria Adults 18 years or older with previously established diagnoses in ASD
<br> will be invited to participate. Adults who have a verbal IQ above 70 or who are students
<br> admitted to a college or university will be included in the study.
<br>
<br> Exclusion Criteria
<br>
<br> - Individuals who are younger than 18 years old or who does not have diagnosis of ASD
<br> will excluded from the study as the purpose of the current research is to evaluate the
<br> validity of ESPs in adults with autism.
<br>
<br> - Adults who are unable to understand English will be excluded because the instruments
<br> being investigated are currently only validated in English and the study team is not
<br> sufficiently fluent in other languages to provide assurance that informed consent
<br> could be obtained (or intervention provided) in a language besides English.
<br>
<br> - Subjects without access to a compatible iOS and Android smartphone (nearly all phones
<br> from the past 10 years are compatible) will be excluded because the study requires
<br> subjects to record responses on a smartphone app. Individuals will not be excluded
<br> from the study based on race, ethnicity or gender.
<br>
<br> - Subjects who have a verbal IQ below 70 will be excluded as this is a study that
<br> requires self-report and engagement in a one-on-one intervention.
<br>
<br> - If the PI's clinical judgment is that it would not be in the adult's best interest to
<br> be enrolled, they may also be excluded.
<br> | | Psychological Distress;Stress, Psychological;Autism Spectrum Disorder | Behavioral: Emotional Support Plan;Behavioral: Daily Monitoring | Decreased anxiety symptoms on the Generalized Anxiety Disorder Questionnaire (GAD-7);Decreased distress on EMA reports;Decreased distress on Patient Health Questionnaire (PHQ-9) | | | | Yes | False | | |
| → | NCT04464408 | 16 March 2021→15 November 2021 | Favipiravir Therapy in Adults With Mild COVID-19 | A Trial of Favipiravir Therapy in Adults With Mild Coronavirus Disease COVID-19 | Avi-Mild | King Abdullah International Medical Research Center | 28/06/2020 | 20200628 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04464408 | Recruiting→Not recruiting | No | 18 Years | 100 Years | All | July 23, 2020 | 576→231 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2/Phase 3 | Saudi Arabia | | Mohammad Bosaeed | | dr.bosaeed@live.com→ | +966(11)8011111→ | →KAMC-RD, Ministry of National Guard Health Affairs (MNGHA), Saudi Arabia |
<br> Inclusion Criteria
<br>
<br> Patients must be eligible according to the following criteria for enrollment
<br>
<br> 1. Should be at least 18 years of age
<br>
<br> 2. Male or non-pregnant female (pregnancy testing is not mandatory. If the patient
<br> requests or is not sure, the study team will provide it)
<br>
<br> 3. Diagnosed with mild COVID-19* confirmed by positive PCR test for SARS-CoV-2 at the
<br> time of recruitment, a result within the last five days
<br>
<br> 4. Patients have to be enrolled within 5 days of disease onset.
<br>
<br> Exclusion criteria
<br>
<br> Patients meeting any of the following criteria will be excluded from trial enrolment:
<br>
<br> 1. Patients with concomitant documented bacterial pneumonia established through positive
<br> sputum cultures
<br>
<br> 2. Patients who are pregnant or breastfeeding
<br>
<br> 3. Known sensitivity/allergy to Favipiravir (If Faviparavir was used for COVID-19 in the
<br> patient previously for influenza)
<br>
<br> 4. Major comorbidities increasing the risk of study drug including
<br>
<br> - Hematologic malignancy
<br>
<br> - Advanced (stage 4-5) chronic kidney disease or dialysis therapy
<br>
<br> - Severe liver damage (Child-Pugh score C, AST> 5 times the upper limit)
<br>
<br> - HIV
<br>
<br> - Gout/history of Gout or hyperuricemia (two times above the ULN)
<br>
<br> (6) Having used Favipiravir or participated in any other interventional drug clinical study
<br> within 30 days before the first dose of study drug (i.e., the patient received it for
<br> influenza previously) (7) The investigator believes that participating in the trial is not
<br> in the best interests of the patient, or the investigator considers unsuitable for
<br> enrollment (such as unpredictable risks or subject compliance issues) (8) Clinical
<br> prognostic non-survival, palliative care, or in a deep coma and have no response to
<br> supportive treatment within three hours of admission.
<br>
<br> (9) Hospitalized patients for mild, moderate, or severe COVID-19
<br> | | COVID-19 | Drug: Favipiravir;Drug: Placebo | PCR negative | | | | Yes | False | | |
| → | NCT04472013 | 18 January 2021→15 November 2021 | Systematic Assessment of SARS-CoV-2 Neurotropic Capacity in Modestly and Critically Ill Patients, and Patients Who Died From COVID-19 | Systematic Assessment of SARS-CoV-2 Neurotropic Capacity in Modestly and Critically Ill Patients, and Patients Who Died From COVID-19 | | University Hospital, Basel, Switzerland | 14/07/2020 | 20200714 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04472013 | Recruiting→Not recruiting | No | 18 Years | N/A | All | August 12, 2020 | 40 | Observational | | | Switzerland | ; ; → | Gregor Hutter, Prof. Dr. med.;Gregor Hutter, Prof. Dr. med.;Gregor Hutter, Prof. Dr. med.→Gregor Hutter, Prof. Dr. med. | | ;Gregor.hutter@usb.ch;gregor.hutter@usb.ch→ | ;+41 61 328 50 68;+41 61 328 50 68→ | Neurosurgery, University Hospital Basel;→Neurosurgery, University Hospital Basel |
<br> Inclusion Criteria:
<br>
<br> - COVID-19 positive tested
<br>
<br> Exclusion Criteria:
<br>
<br> - COVID-19 negative tested
<br>
<br> - pregnant women
<br> | | COVID-19 Disease | Other: Data collection from lumbar puncture;Other: Data collection from blood draw;Other: CNS magnetic resonance imaging (MRI) imaging;Other: Microscopy of defined brain regions on autopsy specimens | MRI imaging data;Proteomic analysis;Peripheral blood leukocyte Cytof Mass Cytometry Analysis for cell population frequency;CODEX (high dimensional microscopy) workflow analysis of defined regions on brain autopsy specimens | | | | Yes | False | | |
| → | NCT04472728 | 8 March 2021→15 November 2021 | Testing the Efficacy and Safety of BIO101 for the Prevention of Respiratory Deterioration in COVID-19 Patients | Adaptive Design Phase 2 to 3, Randomized, Double-blind, to Evaluate Safety, Efficacy, Pharmacokinetics and Pharmacodynamics of BIO101 in the Prevention of the Respiratory Deterioration in Hospitalized COVID-19 Patients | COVA | Biophytis | 06/07/2020 | 20200706 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04472728 | Recruiting | No | 45 Years | N/A | All | June 16, 2020 | 310 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States;Belgium;Brazil;France;Puerto Rico;Belgium;Brazil;France;Puerto Rico;United States→United States;Puerto Rico;France;Brazil;Belgium;Puerto Rico;France;Brazil;Belgium;United States | ; | Capucine Morelot-Panzini, MD;Shmuel Agus, MD→Capucine Morelot-Panzini, MD;Rob Van Maanen, MD | | ;sam.agus@biophytis.com→;rob.vanmaanen@biophytis.com | ;+16176424891→;+33 676 656 192 | Département R3S GHU APHP-Sorbonne Université, Pitié Salpetrière; |
<br> Inclusion Criteria:
<br>
<br> 1. Age: 45 and older (in France: 55 and older)
<br>
<br> 2. A confirmed diagnosis of COVID-19 infection, within the last 28 days, prior to
<br> randomization, as determined by PCR or other approved commercial or public health
<br> assay, in a specimen as specified by the test used.
<br>
<br> 3. Hospitalized, in observation or planned to be hospitalized due to COVID-19 infection
<br> symptoms with anticipated hospitalization duration >=3 days
<br>
<br> a. Patients can be included even if treated with: oxygen supplementation, High-flow
<br> oxygen (HFO2), BiPAP and CPAP
<br>
<br> 4. With evidence of pneumonia based on all of the following:
<br>
<br> 1. Clinical findings on a physical examination
<br>
<br> 2. Respiratory symptoms developed within the past 14 days
<br>
<br> 5. With evidence of respiratory decompensation that started not more than 7 days before
<br> start of study medication and present at screening, meeting one of the following
<br> criteria, as assessed by healthcare staff:
<br>
<br> 1. Tachypnea: =25 breaths per minute
<br>
<br> 2. Arterial oxygen saturation =92%
<br>
<br> 3. A special note should be made if there is suspicion of COVID-19- related
<br> myocarditis or pericarditis, as the presence of these is a stratification
<br> criterion
<br>
<br> 6. Without a significant deterioration in liver function tests:
<br>
<br> 1. ALT and AST = 5x upper limit of normal (ULN)
<br>
<br> 2. Gamma-glutamyl transferase (GGT) = 5x ULN
<br>
<br> 3. Total bilirubin = 5×ULN
<br>
<br> 7. Willing to participate and able to sign an informed consent form (ICF)
<br>
<br> 8. Female subjects should be:
<br>
<br> at least 5 years post-menopausal (i.e., persistent amenorrhea 5 years in the absence
<br> of an alternative medical cause) or surgically sterile; OR
<br>
<br> 1. Have a negative urine pregnancy test at screening
<br>
<br> 2. Be willing to use a contraceptive method as outlined in inclusion criterion 9
<br> from screening to 30 days after last dose.
<br>
<br> 9. Male subjects who are sexually active with a female partner must agree to the use of
<br> an effective method of birth control throughout the study and until 3 months after the
<br> last administration of investigational product; Note: medically acceptable methods of
<br> contraception that may be used by the subject and/or partner include combined oral
<br> contraceptive, contraceptive vaginal ring, contraceptive injection, intrauterine
<br> device, etonogestrel implant, each supplemented with a condom, as well as
<br> sterilization and vasectomy.
<br>
<br> 10. Male subjects must agree not to donate sperm for the purpose of reproduction
<br> throughout the study and until 3 months after the last administration of
<br> investigational product;
<br>
<br> 11. For France only: Being affiliated with a European Social Security.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Not needing or not willing to remain in a healthcare facility during the entire study
<br> medication (i.e. while receiving study medication)
<br>
<br> 2. Moribund condition (death likely in days) or not expected to survive for >7 days - due
<br> to other and non-COVID-19 related conditions
<br>
<br> 3. Patient on invasive mechanical ventilation via an endotracheal tube, or extracorporeal
<br> membrane oxygenation (ECMO)
<br>
<br> 4. Patient within 7 days of participating in other therapeutic clinical trial with
<br> angiotensin-converting-enzyme inhibitors (ACEi), angiotensin receptor blockers (ARB)
<br> or recombinant ACE-2
<br>
<br> 5. Patient not able to take medications by mouth (as capsules or as a powder, mixed in
<br> water).
<br>
<br> 6. Disallowed concomitant medication:
<br>
<br> a. Consumption of any herbal products containing 20-hydroxyecdysone and derived from
<br> Leuzea carthamoides; Cyanotis vaga or Cyanotis arachnoidea is not allowed (e.g.
<br> performance enhancing agents)
<br>
<br> 7. Any known hypersensitivity to any of the ingredients, or excipients of the study
<br> medication, BIO101
<br>
<br> 8. In France:
<br>
<br> - Non-affiliation to compulsory French social security scheme (beneficiary or
<br> right-holder)
<br>
<br> - Being under tutelage or legal guardianship
<br> | | Covid-19;SARS-CoV2 | Drug: BIO101;Drug: Placebo | For the final analysis: Proportion of subjects with all cause mortality or respiratory failure.;For part-2 sample size interim analysis: Proportion of subjects with all cause mortality or with respiratory failure.;End-of-Part 1 interim analysis: Proportion of subjects with all cause mortality or with respiratory failure.→End-of-Part 1 interim analysis: Proportion of subjects with all cause mortality or with respiratory failure.;For part-2 sample size interim analysis: Proportion of subjects with all cause mortality or with respiratory failure.;For the final analysis: Proportion of subjects with all cause mortality or respiratory failure. | | | | Yes | False | | |
| → | NCT04473599 | 12 December 2020→15 November 2021 | Stay Well at Home: a Text-messaging Study Social Distancing | Stay Well at Home: A Text-messaging Study to Improve Mood and Help Cope With Social Distancing | | University of California, Berkeley | 13/07/2020 | 20200713 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04473599 | Recruiting | No | 18 Years | N/A | All | April 17, 2020 | 200 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Single (Participant). | N/A | United States | ; ; | Adrian Aguilera, PhD;Rosa Hernandez-Ramos, Bsc;Rosa Hernandez-Ramos, Bsc→Adrian Aguilera, PhD;Karina Rosales;Karina Rosales | | ;rhernandezramos@berkeley.edu;rhernandezramos@berkeley.edu→;k.rosales@berkeley.edu;k.rosales@berkeley.edu | ;510-642-8564;510-642-8564 | UC Berkeley; |
<br> Inclusion criteria:
<br>
<br> - Over 18 years old
<br>
<br> - Own a mobile phone
<br>
<br> - Speak English or Spanish
<br>
<br> Exclusion criteria:
<br>
<br> - Not owning a mobile phone
<br>
<br> - Under 18 years old
<br> | | Depressive Symptoms;Anxiety;COVID-19 | Behavioral: Uniform random message delivery;Behavioral: Reinforcement learning message delivery→Behavioral: Uniform random message delivery;Behavioral: Reinforcement learning message delivery;Behavioral: Mood ratings only | Anxiety scores;Depression scores→Depression scores;Anxiety scores | | | | Yes | False | | |
| → | NCT04477889 | 12 December 2020→15 November 2021 | Methodist Health System COVID-19 Patient Registry | Methodist Health System COVID-19 Patient Registry | | Methodist Health System | 17/07/2020 | 20200717 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04477889 | Recruiting | No | 18 Years | N/A | All | June 20, 2020 | 500 | Observational | | | United States | ; ; | Crystee Cooper, DHEd;Crystee Cooper, DHEd;Crystee Cooper, DHEd | | ;crysteecooper@mhd.com;CrysteeCooper@mhd.com→;clinicalresearch@mhd.com;CrysteeCooper@mhd.com | ;214-947-1285;214-941-1285 | Methodist Health System; |
<br> Inclusion Criteria:
<br>
<br> - Patient tested positive for COVID-19 (SARS-CoV-2)
<br>
<br> - Patient sought care for COVID-19 at a MHS facility
<br>
<br> - Aged 18 years or older
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient that do not have COVID-19
<br>
<br> - Non-confirmed COVID-19 patients
<br>
<br> - Aged 17 years or younger
<br> | | COVID-19 | Other: Treatment for COVID-19 | Clinical and survival outcomes;Treatment Measures and Intervention strategies;Patient Characteristics | | | | Yes | False | | |
| → | NCT04480424 | 24 August 2021→15 November 2021 | Study to Evaluate the Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Participants in Intensive Care Unit (ICU) With Coronavirus Disease (COVID-19) | A Multicenter, Randomized, Open-label Parallel Group Pilot Study to Evaluate Safety and Efficacy of High Dose Intravenous Immune Globulin (IVIG) Plus Standard Medical Treatment (SMT) Versus SMT Alone in Subjects With COVID-19 Requiring Admission to the Intensive Care Unit | | Grifols Therapeutics LLC | 20/07/2020 | 20200720 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04480424 | Not recruiting | No | 18 Years | N/A | All | September 17, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | | Simon Mahler, MD | | | | Wake Forest Baptist Medical Center |
<br> Inclusion Criteria:
<br>
<br> - Hospitalized male or female subjects of = 18 years of age at time of Screening who are
<br> being treated in the ICU for COVID-19 for not longer than 48 hours or for whom a
<br> decision has been made that COVID-19 disease severity warrants ICU admission.
<br>
<br> - Has laboratory-confirmed novel coronavirus {SARS-CoV-2} infection as determined by
<br> qualitative polymerase chain reaction (PCR) (reverse transcriptase [RT]-PCR), or other
<br> United States Food and Drug Administration (FDA)-approved diagnostic assay for
<br> COVID-19 in any specimen during the current hospital admission prior to randomization.
<br>
<br> - Illness (symptoms of COVID-19 of any duration requiring ICU level care), and the
<br> following:
<br>
<br> 1. Radiographic infiltrates by imaging (chest X-Ray, computerized tomography (CT)
<br> scan, etc.), and
<br>
<br> 2. Requiring mechanical ventilation and/or supplemental oxygen.
<br>
<br> - Any one of the following related to COVID-19: i. Ferritin > 400 nanogram per
<br> milliliter (ng/mL), ii. Lactate dehydrogenase (LDH) > 300 units per liter (U/L), iii.
<br> D-Dimers > reference range, or iv. C-reactive protein (CRP) > 40 milligram per liter
<br> (mg/L).
<br>
<br> - Subject provides informed consent prior to initiation of any study procedures.
<br>
<br> Exclusion Criteria:
<br>
<br> - Clinical evidence of any significant acute or chronic disease or pathophysiologic
<br> manifestations (eg, complications of COVID-19 standard medical treatments) that, in
<br> the opinion of the investigator, may place the subject at undue medical risk.
<br>
<br> - The subject has had a known (documented) serious anaphylactic reaction to blood, any
<br> blood-derived or plasma product or a past history of any hypersensitivity reactions to
<br> commercial immunoglobulin.
<br>
<br> - A medical condition in which the infusion of additional fluid is contraindicated.
<br>
<br> - Shock that is unresponsive to fluid challenge and/or multiple vasopressors and
<br> accompanied by multiorgan failure considered by the Principal Investigator not able to
<br> be reversed.
<br>
<br> - Subjects with known (documented) thrombotic complications to polyclonal IVIG therapy
<br> in the past.
<br>
<br> - Subjects with current or prior myocardial infarction, stroke, deep vein thrombosis, or
<br> thromboembolic event (within the past 12 months) or who have a history of
<br> thromboembolic events of unknown etiology.
<br>
<br> - Subjects with limitations of therapeutic effort.
<br>
<br> - Female subjects who are pregnant or of child-bearing potential with a positive test
<br> for pregnancy blood or urine human chorionic gonadotropin (HCG)-based assay at
<br> Screening/Baseline.
<br>
<br> - Subjects participating in another interventional clinical trial with investigational
<br> medical product or device.
<br>
<br> - Known history of prothrombin gene mutation 20210, homozygous Factor V Leiden
<br> mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or
<br> antiphospholipid syndrome.
<br>
<br> - Presence of malignancy (either new diagnosis of malignancy or known residual disease)
<br> within the past 12 months.
<br>
<br> - Creatinine at Screening is = 4 mg/dL (or subject is dependent on dialysis/renal
<br> replacement therapy).
<br>
<br> - Known Immunoglobulin A (IgA) deficiency with anti-IgA serum antibodies.
<br>
<br> - Uncontrolled hypertension at the time of Screening (systolic blood pressure > 200 mm
<br> Hg) or refractory severe hypotension with sustained systolic blood pressure < 90 mm Hg
<br> unresponsive to vasopressors.
<br> | | COVID-19 | Biological: GAMUNEX-C;Drug: Standard Medical Treatment | All-Cause Mortality Rate Through Day 29 | | | | Yes | False | | |
| → | NCT04482699 | 19 April 2021→15 November 2021 | RAPA-501-Allo Therapy of COVID-19-ARDS | Phase I/Phase II Trial of Allogeneic Hybrid TREG/Th2 Cell (RAPA-501-ALLO) Therapy for COVID-19-Related ARDS | | Rapa Therapeutics LLC | 20/07/2020 | 20200720 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04482699 | Recruiting→Not recruiting | No | 18 Years | N/A | All | December 30, 2020 | 88→1 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 1/Phase 2 | United States | ; ; → | Daniel Fowler, M.D.;Jennifer Gough Clinical & Regulatory Specialist;Michele Donato Principal Investigator→Daniel Fowler, M.D. | | ;jgough@rapatherapeutics.com;michele.donato@hackensackmeridian.org→ | ;617-285-4774;551-996-5855→ | Rapa Therapeutics LLC;→Rapa Therapeutics LLC |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female participants = 18 years of age.
<br>
<br> 2. Participants with SARS-CoV-2 infection, as defined by standard reverse transcriptase
<br> polymerase chain reaction (RT-PCR) assay or equivalent test.
<br>
<br> 3. Must have pulmonary infiltrate on radiologic examination.
<br>
<br> 4. Participant must have a clinical diagnosis of high-risk ARDS (as defined by a
<br> PaO2-to-FiO2 ratio of < 150 mm Hg) requiring intensive respiratory support, including
<br> non-invasive methods such as high-flow nasal cannula or mechanical ventilation.
<br>
<br> 5. AST and ALT = 3 x upper limit of normal (ULN).
<br>
<br> 6. Consent must be given before performance of any study related procedure not part of
<br> standard medical care, with the understanding that consent may be withdrawn at any
<br> time without prejudice to future medical care. Informed consent can be obtained from
<br> healthcare proxy if the participant is unable to provide consent due to medical
<br> status.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Active uncontrolled infection with a non-COVID-19 agent.
<br>
<br> 2. Diagnosis of ARDS that is not considered to be high-risk, as defined by PaO2-to-FiO2
<br> ratio of = 150 mm Hg.
<br>
<br> 3. Any irreversible disease or condition for which 6-month mortality is estimated to be
<br> greater than 50%.
<br>
<br> 4. End-stage liver disease with ascites unrelated to COVID-19 (Childs Pugh score > 12).
<br>
<br> 5. Uncontrolled or significant cardiovascular disease, including but not limited to: (a)
<br> myocardial infarction, stroke, or transient ischemic attack within the past 30 days;
<br> (b) uncontrolled angina within the past 30 days; (c) any history of clinically
<br> significant arrhythmias such as ventricular tachycardia, ventricular fibrillation, or
<br> torsades de pointes; and (d) history of other clinically significant or uncontrolled
<br> heart disease, including: cardiomyopathy, congestive heart failure with New York Heart
<br> Association functional classification III or IV, myocarditis, pericarditis, or
<br> significant pericardial effusion.
<br>
<br> 6. Known chronic kidney disease of Stage 4 or 5 severity or requiring hemodialysis.
<br>
<br> 7. COVID-19-associated acute kidney injury requiring dialysis.
<br>
<br> 8. HIV, hepatitis B, or hepatitis C seropositive.
<br>
<br> 9. Patients with baseline QTc interval prolongation, as defined by repeated demonstration
<br> of a QTc interval >500 milliseconds.
<br>
<br> 10. Patients on hydroxychloroquine (must discontinue at least 2-days before study entry).
<br>
<br> 11. Pregnant or breastfeeding participants.
<br>
<br> 12. Patients of childbearing age, or males who have a partner of childbearing potential,
<br> who are unwilling to practice contraception. Effective forms of birth control, which
<br> must be continued through the entire on-study 6-month interval, include: Abstinence;
<br> Intrauterine device (IUD); Hormonal (birth control pills, injections, or implants);
<br> Tubal ligation; or Vasectomy.
<br>
<br> 13. Participants with malignancy requiring active therapy (not including non-melanoma skin
<br> cancer).
<br>
<br> 14. Recipients of allogeneic hematopoietic cell transplant or solid organ transplant.
<br>
<br> 15. History of WHO Class III or IV pulmonary hypertension.
<br>
<br> 16. Severe thromboembolic disease, as defined by: administration of thrombolytic agents,
<br> insertion of vena cava filter, or pulmonary thrombectomy within one-week interval
<br> prior to screening.
<br>
<br> 17. Participants may be excluded at the discretion of the PI or if it is deemed that
<br> allowing participation would represent an unacceptable medical or psychiatric risk.
<br> | | Severe COVID-19 Disease | Biological: RAPA-501-Allo off-the-shelf Therapy of COVID-19;Other: Placebo | Mortality Rate;Dose-Limiting Toxicity (DLT)→Dose-Limiting Toxicity (DLT);Mortality Rate | | | | Yes | False | | |
| → | NCT04490174 | 10 August 2021→15 November 2021 | Serological Surveillance for COVID-19 in Central North Carolina | Serological Surveillance for COVID-19 in Central North Carolina | | National Institute of Environmental Health Sciences (NIEHS) | 28/07/2020 | 20200728 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04490174 | Recruiting | No | 18 Years | N/A | All | January 8, 2020 | 2500 | Observational | | | United States | ; ; | Stavros Garantziotis, M.D.;NIEHS Join A Study Recruitment Group;Nicole Edwards | | ;myniehs@nih.gov;nicole.edwards@nih.gov | ;(855) 696-4347;984-287-4416 | National Institute of Environmental Health Sciences (NIEHS); |
<br> - INCLUSION CRITERIA:
<br>
<br> In order to be eligible to participate in this study, an individual must meet all of the
<br> following criteria:
<br>
<br> 1. Male and females
<br>
<br> 2. greater than or equal to 18 years of age
<br>
<br> 3. Able to read and speak English
<br>
<br> 4. Ability to provide informed consent
<br>
<br> 5. Able to travel to study visits at the NIEHS CRU for required study visits
<br>
<br> 6. Stated willingness to comply with all study procedures and availability for the
<br> duration of the study
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> An individual who meets any of the following criteria will be excluded from participation
<br> in this study:
<br>
<br> 1. Current symptoms consistent with COVID-19 infection at the point of Antibody Visit 1
<br>
<br> 2. Inability to provide a blood sample
<br>
<br> 3. Any condition that, in the investigator's opinion, places the participant at undue
<br> risk for complications associated with required study procedures.
<br>
<br> 4. Not willing to have blood samples stored for future research
<br>
<br> Participants who have Limited English Proficiency will be excluded from the study because
<br> the informed consent form is only available in English. The study documents (Demographic
<br> and Health Assessment Questionnaire, and Weekly Symptom Questionnaire) and FDA Fact Sheets
<br> for Tests with Emergency Use Authorization are only available in English.
<br> →
<br> - INCLUSION CRITERIA:
<br>
<br> In order to be eligible to participate in this study, an individual must meet all of the
<br> following criteria:
<br>
<br> 1. Male and females
<br>
<br> 2. greater than or equal to 18 years of age
<br>
<br> 3. Able to read and speak English
<br>
<br> 4. Ability to provide informed consent
<br>
<br> 5. Able to travel to study visits at the NIEHS CRU for required study visits
<br>
<br> 6. Stated willingness to comply with all study procedures and availability for the
<br> duration of the study
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> An individual who meets any of the following criteria will be excluded from participation
<br> in this study:
<br>
<br> 1. Current symptoms consistent with COVID-19 infection at the point of Antibody Visit 1
<br>
<br> 2. Inability to provide a blood sample
<br>
<br> 3. Current pregnancy or lactation, by participant verbal confirmation.
<br>
<br> 4. Any condition that, in the investigator's opinion, places the participant at undue
<br> risk for complications associated with required study procedures.
<br>
<br> 5. Not willing to have blood samples stored for future research
<br>
<br> Participants who have Limited English Proficiency will be excluded from the study because
<br> the informed consent form is only available in English. The study documents (Demographic
<br> and Health Assessment Questionnaire, and Weekly Symptom Questionnaire) and FDA Fact Sheets
<br> for Tests with Emergency Use Authorization are only available in English.
<br>
<br> Decisionally impaired adults and prisoners will be excluded due to the inability to
<br> complete necessary study procedures. Adults who become prisoners or decisionally impaired
<br> while on study will be withdrawn.
<br>
<br> Pregnant women are excluded due to the need to have participants venture out during the
<br> COVID-19 pandemic. Women who become pregnant during the study will be withdrawn.
<br>
<br> Children will be excluded from enrolling in this study as immunity in children is different
<br> than
<br>
<br> adults and we are focusing on adult immunity and in this trial
<br> | | COVID-19 | | Anti-SARS-COV-2 antibodies | | | | Yes | False | | |
| → | NCT04498247 | 22 March 2021→15 November 2021 | A Study to Assess Safety, Tolerability, and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Participants (V591-001) | A Phase 1/Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Safety, Tolerability and Immunogenicity of V591 (COVID-19 Vaccine) in Healthy Younger and Older Participants | | Merck Sharp & Dohme Corp. | 03/08/2020 | 20200803 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04498247 | Not recruiting | No | 18 Years | N/A | All | August 27, 2020 | 263 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | United States;Belgium;Austria;Belgium;Austria;United States | | Medical Director | | | | Merck Sharp & Dohme Corp. |
<br> Inclusion Criteria:
<br>
<br> - Is in overall good health based on medical history, physical examination,
<br> electrocardiogram (ECG) and vital sign (VS) measurements performed prior to
<br> randomization.
<br>
<br> - Is in overall good health based on laboratory safety tests obtained at the screening
<br> visit.
<br>
<br> - Has a body mass index (BMI) <30 kg/m2 inclusive. On this basis a rounded BMI of 29.9
<br> is acceptable to satisfy the inclusion criteria. BMI = weight (kg)/height (m)2.
<br>
<br> - Has been practicing social distancing for at least two weeks prior to planned Day 1
<br> vaccination and has no close contacts with known active severe acute respiratory
<br> syndrome coronavirus (SARS-CoV)-2 infection in that time period.
<br>
<br> - Sentinel trial participants ONLY (Panel A, Panel B, and the first 5 participants of
<br> Panel E): Seronegative for SARS-COV-2.
<br>
<br> - Is male or female, from 18 years to 55 years of age (inclusive) (Parts 1 and 2A) or
<br> >55 years of age (Part 2B), at the time of providing documented informed consent.
<br>
<br> - Male participants are eligible to participate if they agree to refrain from donating
<br> sperm during the intervention period and for at least 6 months after the last dose of
<br> study intervention, be abstinent from heterosexual intercourse as their preferred and
<br> usual lifestyle and agree to remain abstinent OR agree to use contraception unless
<br> confirmed to be azoospermic .
<br>
<br> - Contraceptive use by men and women should be consistent with local regulations
<br> regarding the methods of contraception for those participating in clinical studies.
<br>
<br> - A female participant is eligible to participate if she is not pregnant or
<br> breastfeeding, is not a woman of childbearing potential (WOCBP) or Is a WOCBP and
<br> using an acceptable contraceptive method or be abstinent from heterosexual intercourse
<br> as their preferred and usual lifestyle.
<br>
<br> - A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as
<br> required by local regulations) before the first dose of study intervention. If a urine
<br> test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy
<br> test is required. In such cases, the participant must be excluded from participation
<br> if the serum pregnancy result is positive.
<br>
<br> - Refrain from donating oocyte during the intervention period and for at least 6 months
<br> after the last dose of study intervention.
<br>
<br> - The investigator is responsible for review of medical history, menstrual history, and
<br> recent sexual activity to decrease the risk for inclusion of a woman with an early
<br> undetected pregnancy.
<br>
<br> - The participant (or legally acceptable representative) has provided documented
<br> informed consent/assent for the study, including for future biomedical research.
<br>
<br> - Is willing to comply with the study restrictions, including social distancing between
<br> screening and randomization.
<br>
<br> - Is willing to abstain from donating whole blood or blood derivatives, tissue or organ
<br> all along the study.
<br>
<br> - Agrees to provide study personnel with a primary telephone number as well as an
<br> alternate means of contact, if available (such as an alternate telephone number or
<br> email) for follow-up purposes.
<br>
<br> - Can read, understand, and complete the Vaccination Report Card.
<br>
<br> Exclusion Criteria
<br>
<br> - Is currently actively infected with SARS-CoV-2 (confirmed by polymerase chain
<br> reaction;[PCR]).
<br>
<br> - Has prior medical history of confirmed SARS-CoV-2 infection or known exposure to an
<br> individual with confirmed coronavirus disease 2019 (COVID-19) disease or SARS CoV-2
<br> infection within the past 2 weeks. With the exception of the sentinel participants
<br> (Panel A, Panel B, and the first 5 participants of Panel E), study participants will
<br> not be screened for enrollment by SARS-CoV-2 serology, allowing those who may have had
<br> a prior asymptomatic SARS-CoV-2 infection to be enrolled.
<br>
<br> - Has a history of severe adverse reactions to vaccine administration, including
<br> anaphylaxis and related symptoms, such as urticaria, respiratory difficulty,
<br> angioedema and abdominal pain to vaccines, or history of known or suspected allergic
<br> reaction likely to be exacerbated by any component of the COVID-19 vaccine.
<br>
<br> - Is currently (or highly suspected to be) immunocompromised, including anticipating the
<br> need for systemic immunosuppressive treatment within the next 6 months or 12 months
<br> for 2-dose Day 1, Day 169 panels or has been diagnosed or highly suspected as having a
<br> congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, systemic
<br> lupus erythematosus (SLE), rheumatoid arthritis, juvenile rheumatoid arthritis (JRA),
<br> inflammatory bowel disease, or other autoimmune condition that could impact the immune
<br> response or the safety of the study vaccine.
<br>
<br> - Has clinically significant thrombocytopenia or other coagulation disorder
<br> contraindicating intramuscular vaccination or repeated venipuncture.
<br>
<br> - Has history or current evidence of any condition, therapy, laboratory abnormality, or
<br> other circumstance that might expose the participant to risk by participating in the
<br> study, confound the results of the study or interfere with the participant's
<br> participation for the full duration of the study.
<br>
<br> - Has a history or presence of clinically significant pulmonary disorders (e.g. chronic
<br> obstructive pulmonary disease [COPD], etc.), or asthma.
<br>
<br> - Has a history of confirmed SARS-CoV-1 or Middle Eastern respiratory syndrome (MERS)
<br>
<br> - Has a history of or current clinically significant medical condition that puts or may
<br> put a participant at increased risk for severe SARS-CoV-2 disease, such as conditions
<br> associated with increased risk of severe illness from COVID-19, cancer, chronic kidney
<br> disease, COPD, immunocompromised state (weakened immune system) from solid organ
<br> transplant, obesity (BMI of 30 or higher), serious heart conditions, such as heart
<br> failure, coronary artery disease, or cardiomyopathies, sickle cell disease, Type 2
<br> diabetes mellitus, asthma, cerebrovascular disease, cystic fibrosis, hypertension or
<br> high blood pressure, an immunocompromised state (weakened immune system), neurologic
<br> conditions, such as dementia, liver disease, pregnancy, pulmonary fibrosis (having
<br> damaged or scarred lung tissues), smoking, thalassemia (a type of blood disorder), or
<br> Type 1 diabetes mellitus.
<br>
<br> - Part 2B ONLY: Older adult participants having mild, well controlled hypertension as is
<br> widely characteristic of aging are allowed if their medication regimens have not
<br> substantively changed for the past 6 months, hypertension has | | Coronavirus Disease (COVID-19) | Biological: V591;Other: Placebo | Percentage of Participants with at Least 1 Medically Attended Adverse Event;Percentage of Participants who Discontinued Study Treatment due to an Adverse Event;Percentage of Participants with at Least 1 Serious Adverse Event;Percentage of Participants with at Least 1 Unsolicited Adverse Event;Percentage of Participants with at Least 1 Solicited Systemic Adverse Event;Percentage of Participants with at Least 1 Solicited Injection Site Adverse Event | | | | Yes | False | | |
| → | NCT04498377 | 8 February 2021→15 November 2021 | Study of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19 | A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Multicenter Study to Evaluate the Efficacy and Safety of F-652 (IL-22:IgG2 Fusion Protein) in Patients With Moderate to Severe COVID-19 | | Generon (Shanghai) Corporation Ltd. | 31/07/2020 | 20200731 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04498377 | Recruiting | No | 18 Years | N/A | All | January 26, 2021 | 38 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | United States | ; ; | Christine M Bojanowski, MD;William L Daley, MD;Cynthia Moreau, RN | | ;william.daley@evivebiotech.com;cmoreau@tulane.edu | ;908-845-9619; | Tulane University; |
<br> Inclusion Criteria:
<br>
<br> - Willing to provide informed consent and able to comply with protocol requirements
<br>
<br> - 18 years or older
<br>
<br> - Has a COVID-19 diagnosis confirmed by PCR
<br>
<br> - Hospitalized within 5 days and meets the following criteria at screening:
<br>
<br> Peripheral capillary oxygen saturation (SpO2) = 93% on room air or SpO2 =93% on =10 liters
<br> per minute of supplemental oxygen via nasal cannula
<br>
<br> - Radiographic (chest X-ray, computed tomography scan, or ultrasound) evidence of
<br> bilateral pulmonary infiltrates consistent with SARS-CoV-2/COVID-19
<br>
<br> - Clinical symptoms consistent with COVID-19 per Investigator judgement
<br>
<br> - Body mass index between 18 to 40 kg/m2
<br>
<br> - If of reproductive potential, willing to abstain or agree to the use of highly
<br> effective contraception
<br>
<br> Exclusion Criteria:
<br>
<br> - Respiratory failure at screening
<br>
<br> - History of heart failure
<br>
<br> - History of COPD or bronchial asthma
<br>
<br> - Active TB or history of TB of the following types
<br>
<br> - Uncontrolled arrhythmia within 3 months prior to randomization
<br>
<br> - Heart disease of the following types
<br>
<br> - Moderate to severe renal insufficiency
<br>
<br> - Abnormal white cell and platelet counts
<br>
<br> - History of transplantation of vital organs (e.g., heart, lung, liver, and/or kidney);
<br>
<br> - Malignant tumor
<br>
<br> - Uncontrolled systemic or local autoimmune or inflammatory disease besides SARS-CoV-2
<br>
<br> - Unhealed wounds, active gastric ulcer, had surgery
<br>
<br> - Received other investigational therapeutic products
<br>
<br> - Used interferon therapies
<br>
<br> - History of HIV infection, hepatitis B, and/or hepatitis C
<br>
<br> - Known serious allergic reaction or hypersensitivity to components of F-652
<br>
<br> - Pregnant or breastfeeding
<br>
<br> - History of drug abuse or use of narcotics
<br>
<br> - Treated with immunomodulators or immunosuppressants
<br>
<br> - Other conditions resulting in increased risk
<br> | | Covid19 | Biological: F-652;Biological: Placebo | NIAID 8-point ordinal scale | | | | Yes | False | | |
| → | NCT04501978 | 1 November 2021→15 November 2021 | ACTIV-3: Therapeutics for Inpatients With COVID-19 | A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With COVID-19 | TICO | University of Minnesota | 03/08/2020 | 20200803 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04501978 | Recruiting | Yes | 18 Years | N/A | All | August 4, 2020 | 10000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | Switzerland;Uganda;United Kingdom;United States;Spain;Singapore;Poland;Nigeria;Mozambique;India;Greece;Georgia;Denmark;Argentina;United Kingdom;Uganda;Switzerland;Spain;Singapore;Poland;Nigeria;Mozambique;India;Greece;Georgia;Denmark;Argentina;United States | ; ; | Prof. Jens Lundgren;Prof. James Neaton;If interested in participating in this study, please contact the appropriate site or | | ;;tico@insight-trials.org | ;;send email to | INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen;INSIGHT Statistical and Coordinating Centre, University of Minnesota; |
<br> Inclusion Criteria:
<br>
<br> - Signed informed consent.
<br>
<br> - Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19
<br> infection.
<br>
<br> - Symptoms of COVID-19 for = 12 days.
<br>
<br> - Require admission to hospital for acute medical care (not for purely public health or
<br> quarantine purposes).
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who have received plasma from a person who recovered from COVID-19 or who
<br> have received neutralizing monoclonal antibodies at any time prior to hospitalization.
<br>
<br> - Patients not willing to abstain from participation in other COVID-19 treatment trials
<br> until after Day 5 of the study. Co-enrollment in certain trials that compare
<br> recommended Standard of Care treatments may be allowed, based on the opinion of the
<br> study leadership team.
<br>
<br> - Any condition which, in the opinion of the responsible investigator, participation
<br> would not be in the best interest of the participant or that could prevent, limit, or
<br> confound the protocol-specified assessments.
<br>
<br> - Patients considered unable to participate in study procedures.
<br>
<br> - Women of child-bearing potential who are not already pregnant at study entry and who
<br> are unwilling to acknowledge strong advice to abstain from sexual intercourse with men
<br> or practice appropriate contraception through 18 months of the study.
<br>
<br> - Women of child-bearing potential who are unwilling to acknowledge the strong advice to
<br> abstain from sexual intercourse with men or practice appropriate contraception through
<br> 5 weeks of the study (PF-07304814 investigational agent).
<br>
<br> - Pregnant women (AZD7442, MP0420 and PF-07304814 investigational agents).
<br>
<br> - Nursing mothers (AZD7442, MP0420 and PF-07304814 investigational agents).
<br>
<br> - Men who are unwilling to acknowledge the strong advice to abstain from sexual
<br> intercourse with women of child-bearing potential or to use barrier contraception
<br> through 18 months of the study.
<br>
<br> - Men who are unwilling to acknowledge the strong advice to abstain from sexual
<br> intercourse with women of child-bearing potential or to use barrier contraception
<br> through 5 weeks of the study (PF-07304814 investigational agent).
<br>
<br> - Presence at study enrollment of any of the following:
<br>
<br> 1. stroke
<br>
<br> 2. meningitis
<br>
<br> 3. encephalitis
<br>
<br> 4. myelitis
<br>
<br> 5. myocardial ischemia
<br>
<br> 6. myocarditis
<br>
<br> 7. pericarditis
<br>
<br> 8. symptomatic congestive heart failure
<br>
<br> 9. arterial or deep venous thrombosis or pulmonary embolism
<br>
<br> - Current or imminent requirement for any of the following:
<br>
<br> 1. invasive mechanical ventilation
<br>
<br> 2. ECMO (extracorporeal membrane oxygenation)
<br>
<br> 3. Mechanical circulatory support
<br>
<br> 4. vasopressor therapy
<br>
<br> 5. commencement of renal replacement therapy at this admission (i.e. not patients on
<br> chronic renal replacement therapy).
<br>
<br> - Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C)
<br> or acute liver failure (PF-07304814 investigational agent).
<br>
<br> - Participants receiving any medications or substances that are strong inhibitors or
<br> inducers of cytochrome P450 (CYP) 3A4 (PF-07304814 investigational agent).
<br>
<br> - Patients will be excluded if taking drugs which have a narrow therapeutic window that
<br> are substrates of CYP3A4, including but not limited to: astemizole, cisapride,
<br> cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus,
<br> tacrolimus, and terfenadine (PF-07304814 investigational agent).
<br>
<br> - Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism
<br> (Prior to initial futility assessment of PF-07304814 investigational agent).
<br> →
<br> Inclusion Criteria:
<br>
<br> - Signed informed consent.
<br>
<br> - Positive test for COVID-19 and progressive disease suggestive of ongoing COVID-19
<br> infection.
<br>
<br> - Symptoms of COVID-19 for = 12 days.
<br>
<br> - Require admission to hospital for acute medical care (not for purely public health or
<br> quarantine purposes).
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who have received plasma from a person who recovered from COVID-19 or who
<br> have received neutralizing monoclonal antibodies at any time prior to hospitalization.
<br>
<br> - Patients not willing to abstain from participation in other COVID-19 treatment trials
<br> until after Day 5 of the study. Co-enrollment in certain trials that compare
<br> recommended Standard of Care treatments may be allowed, based on the opinion of the
<br> study leadership team.
<br>
<br> - Any condition which, in the opinion of the responsible investigator, participation
<br> would not be in the best interest of the participant or that could prevent, limit, or
<br> confound the protocol-specified assessments.
<br>
<br> - Patients considered unable to participate in study procedures.
<br>
<br> - Women of child-bearing potential who are not already pregnant at study entry and who
<br> are unwilling to acknowledge strong advice to abstain from sexual intercourse with men
<br> or practice appropriate contraception through 18 months of the study.
<br>
<br> - Women of child-bearing potential who are unwilling to acknowledge the strong advice to
<br> abstain from sexual intercourse with men or practice appropriate contraception through
<br> 5 weeks of the study (PF-07304814 investigational agent).
<br>
<br> - Pregnant women (MP0420 and PF-07304814 investigational agents).
<br>
<br> - Nursing mothers (MP0420 and PF-07304814 investigational agents).
<br>
<br> - Men who are unwilling to acknowledge the strong advice to abstain from sexual
<br> intercourse with women of child-bearing potential or to use barrier contraception
<br> through 18 months of the study.
<br>
<br> - Men who are unwilling to acknowledge the strong advice to abstain from sexual
<br> intercourse with women of child-bearing potential or to use barrier contraception
<br> through 5 weeks of the study (PF-07304814 investigational agent).
<br>
<br> - Presence at study enrollment of any of the following:
<br>
<br> 1. stroke
<br>
<br> 2. meningitis
<br>
<br> 3. encephalitis
<br>
<br> 4. myelitis
<br>
<br> 5. myocardial ischemia
<br>
<br> 6. myocarditis
<br>
<br> 7. pericarditis
<br>
<br> 8. symptomatic congestive heart failure
<br>
<br> 9. arterial or deep venous thrombosis or pulmonary embolism
<br>
<br> - Current or imminent requirement for any of the following:
<br>
<br> 1. invasive mechanical ventilation
<br>
<br> 2. ECMO (extracorporeal membrane oxygenation)
<br>
<br> 3. Mechanical circulatory support
<br>
<br> 4. vasopressor therapy
<br>
<br> 5. commencement of renal replacement therapy at this admission (i.e. not patients on
<br> chronic renal replacement therapy).
<br>
<br> - Participants with moderate to severe hepatic impairment (i.e. Child-Pugh class B or C)
<br> or acute liver failure (PF-07304814 investigational agent).
<br>
<br> - Participants receiving any medications or substances that are strong inhibitors or
<br> inducers of cytochrome P450 (CYP) 3A4 (PF-07304814 investigational agent).
<br>
<br> - Patients will be excluded if taking drugs which have a narrow therapeutic window that
<br> are substrates of CYP3A4, including but not limited to: astemizole, cisapride,
<br> cyclosporine, dihydroergotamine, ergotamine, pimozide, quinidine, sirolimus,
<br> tacrolimus, and terfenadine (PF-07304814 investigational agent).
<br>
<br> - Patients with a history of deep vein thrombosis or pulmonary thrombotic embolism
<br> (Prior to initial futility assessment of PF-07304814 investigational agent).
<br> | | Covid19 | Biological: LY3819253;Drug: Placebo;Biological: Remdesivir;Biological: VIR-7831;Biological: BRII-196/BRII-198;Biological: AZD7442;Drug: MP0420;Drug: PF-07304814 | Time from randomization to sustained recovery | | | | Yes | True | parent | |
| → | NCT04506515 | 12 December 2020→15 November 2021 | Psychological Impact of COVID-19 Pandemic in Healthcare Workers | Psychological Impact of COVID-19 Pandemic in Healthcare Workers in Spain: A Cross-sectional Study. PSIMCOV Group | PSIMCOV | Hospital General Universitario de Valencia | 03/08/2020 | 20200803 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04506515 | Not recruiting | No | 18 Years | 70 Years | All | April 9, 2020 | 3000 | Observational | | | Spain | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Active healthcare workers in any private/public hospital > 18 years old
<br>
<br> Exclusion Criteria:
<br>
<br> - Refusal to participate
<br> | | Covid19;Stress, Psychological;Work Related Stress;Epidemic Disease;SARS-CoV Infection | Diagnostic Test: Psychological stress and adaptation at work score (PSAS) | PSAS (Psychological Stress and Adaptation at work Score) during the crisis | | | | Yes | False | | |
| → | NCT04508023 | 26 October 2021→15 November 2021 | A Study of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic Coronavirus Disease 2019 (COVID-19) Infection | A Multicenter, Randomized, Placebo-Controlled, Pragmatic Phase 3 Study Investigating the Efficacy and Safety of Rivaroxaban to Reduce the Risk of Major Venous and Arterial Thrombotic Events, Hospitalization and Death in Medically Ill Outpatients With Acute, Symptomatic COVID-19 Infection | PREVENT-HD | Janssen Research & Development, LLC | 10/08/2020 | 20200810 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04508023 | Recruiting | No | 18 Years | N/A | All | August 13, 2020 | 4000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 3 | United States | ; | Janssen Research & Development, LLC Clinical Trial;Study Contact | | ;JNJ.CT@sylogent.com | ;844-434-4210 | Janssen Research & Development, LLC; |
<br> Inclusion Criteria:
<br>
<br> - Coronavirus Disease 2019 (COVID-19) positive diagnosis by locally obtained viral
<br> diagnostic test (example, polymerase chain reaction [PCR]). This may be nasal swab or
<br> saliva test or other available technology to demonstrate current infection
<br>
<br> - Confirm that participant is known to health system, with at least 1 contact in
<br> electronic medical records (EMR) prior to screening
<br>
<br> - Symptoms attributable to COVID-19 (example, fever, cough, loss of taste or smell,
<br> muscle aches, shortness of breath, fatigue)
<br>
<br> - Initial treatment plan does not include hospitalization
<br>
<br> - Presence of at least 1 additional risk factor: a) age more than or equal to (>=) 60
<br> years; b) prior history of VTE; c) history of thrombophilia; d) history of coronary
<br> artery disease (CAD); e) history of peripheral artery disease (PAD); f) history of
<br> cerebrovascular disease or ischemic stroke; g) history of cancer (other than basal
<br> cell carcinoma) h) history of diabetes requiring medication; i) history of heart
<br> failure; j) body mass index (BMI) greater than or equal to (>=) 35 kilogram per meter
<br> square (kg/m^2); k) D-dimer greater than (>) upper limit of normal for local
<br> laboratory (within 2 weeks of the date of the COVID-19 test and prior to
<br> randomization)
<br>
<br> Exclusion Criteria:
<br>
<br> - Increased risk of bleeding such as a) significant bleeding in the last 3 months; b)
<br> active gastroduodenal ulcer in the last 3 months; c) history of bronchiectasis or
<br> pulmonary cavitation; d) need for dual antiplatelet therapy or anticoagulation; e)
<br> prior intracranial hemorrhage, f) known severe thrombocytopenia g) active cancer and
<br> undergoing treatment
<br>
<br> - Any illness or condition that in the opinion of the investigator would significantly
<br> increase the risk of bleeding (example recent trauma, recent surgery, severe
<br> uncontrolled hypertension, gastrointestinal cancer, renal failure requiring dialysis,
<br> severe liver disease, known bleeding diathesis)
<br>
<br> - Known allergies, hypersensitivity, or intolerance to rivaroxaban or its excipients
<br>
<br> - Positive COVID-19 antibody or serology test after 2-week period of acute, symptomatic
<br> COVID-19 infection
<br>
<br> - Known diagnosis of triple positive (positive for lupus anticoagulant, anticardiolipin,
<br> and anti-beta 2-glycoprotein I antibodies) antiphospholipid syndrome
<br> | | Coronavirus Disease 2019 (COVID-19) | Drug: Rivaroxaban;Other: Placebo;Other: Standard of Care (SOC) | Time to First Occurrence of a Composite Endpoint of Symptomatic VTE, MI, Ischemic Stroke, Acute Limb Ischemia, Non-CNS Systemic Embolization, All-cause Hospitalization and All-cause Mortality | | | | Yes | False | | |
| → | NCT04523571 | 12 December 2020→15 November 2021 | Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects | Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects: A Phase I, Randomized, Placebo-controlled, Observer-blind Study | | BioNTech RNA Pharmaceuticals GmbH→BioNTech SE | 18/08/2020 | 20200818 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04523571 | Not recruiting | No | 18 Years | 85 Years | All | July 28, 2020 | 144 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor). | Phase 1 | China | | BioNTech Responsible Person | | | | BioNTech SE |
<br> Inclusion Criteria:
<br>
<br> For adult group (age =18 and =55)
<br>
<br> - Male or female subjects of =18 years old and =55 years old with body mass index (BMI)
<br> =18 and =30 at the Screening Visit.
<br>
<br> - Individuals who are in good health condition at the time of entry into the trial as
<br> determined by medical history, physical examination (including vital signs,
<br> electrocardiogram [ECG]) and eligibility screening test (hematology, blood chemistry
<br> and urine analysis) and clinical judgment of the investigator at Screening Visit.
<br>
<br> - The subject can provide with informed consent and signs and dates a written informed
<br> consent form (ICF) prior to the initiation of any trial procedures.
<br>
<br> - They must be able to understand and follow trial-related instructions.
<br>
<br> - They must be willing and able to comply with planned visits, treatment schedule,
<br> laboratory tests and other requirements of the trial.
<br>
<br> - Negative in antibodies screening of SARS-CoV-2 (fingerstick).
<br>
<br> - Normal in chest computed tomography (CT) scans (no imaging features of COVID-19).
<br>
<br> - Axillary temperature = 37.0ºC.
<br>
<br> - Negative SARS-CoV-2 test in throat swabs by reverse transcription-polymerase chain
<br> reaction (RT-PCR).
<br>
<br> - Women of childbearing potential (WOCBP) must have a negative beta-human chorionic
<br> gonadotropin (ß-hCG) in serum sample at Screening Visit. Women that are postmenopausal
<br> (Menopause=12 consecutive months) or permanently sterilized will be considered as not
<br> having reproductive potential.
<br>
<br> - WOCBP must have used effective contraception 14 days prior to screening and agree to
<br> use effective contraception continuously during the trial period, from 14 days prior
<br> to Screening Visit to 60 days after the last immunization.
<br>
<br> - WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted
<br> reproduction during trial, starting from Screening Visit and continuously until 60
<br> days after being given the last immunization.
<br>
<br> - Men who are sexually active with a WOCBP and have not had a vasectomy must agree to
<br> practice an effective form of contraception with their female partner of childbearing
<br> potential during the trial, starting from Screening Visit and continuously until 60
<br> days after being given the last immunization.
<br>
<br> - Men must be willing to refrain from sperm donation, starting from Screening Visit and
<br> continuously until 60 days after receiving the last immunization.
<br>
<br> For the elderly group (age =65 and =85)
<br>
<br> - Male or female subjects =65 years old and =85 years old at Screening Visit
<br>
<br> - Individuals who are in a health condition that can receive the investigational
<br> vaccine, at the time of entry into the trial as determined by medical history,
<br> physical examination (including vital signs, ECG) and eligibility screening tests
<br> (hematology, biochemistry and urinalysis) and clinical judgment of the investigator at
<br> Screening Visit.
<br>
<br> - The subject can provide with informed consent and signs and dates a written ICF prior
<br> to the initiation of any trial procedures.
<br>
<br> - They must be able to understand and follow trial-related instructions.
<br>
<br> - They must be willing and able to comply with planned visits, treatment schedule,
<br> laboratory tests and other requirements of the trial.
<br>
<br> - Negative in antibodies screening of SARS-CoV-2 (blood sample from fingertip).
<br>
<br> - No imaging features of COVID-19 in chest CT.
<br>
<br> - Axillary temperature = 37.0ºC.
<br>
<br> - Negative SARS-CoV-2 test in throat swabs by RT-PCR.
<br>
<br> - WOCBP must have a negative serum ß-hCG at Screening Visit. Women that are
<br> postmenopausal (Menopause =12 consecutive months) or permanently sterilized will be
<br> considered as not having reproductive potential.
<br>
<br> - WOCBP must have used effective contraception 14 days prior to screening and agree to
<br> use effective contraception continuously during the trial period, from 14 days prior
<br> to Screening Visit to 60 days after the last immunization.
<br>
<br> - WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted
<br> reproduction during trial, starting from Screening Visit and continuously until 60
<br> days after being given the last immunization.
<br>
<br> - Men who are sexually active with a WOCBP and have not had a vasectomy must agree to
<br> practice an effective form of contraception with their female partner of childbearing
<br> potential during the trial, starting from Screening Visit and continuously until 60
<br> days after being given the last immunization.
<br>
<br> - Men must be willing to refrain from sperm donation, starting from Screening Visit and
<br> continuously until 60 days after receiving the last immunization.
<br>
<br> Exclusion Criteria:
<br>
<br> For adult group (age =18 and =55)
<br>
<br> - Have had any acute illness, as determined by the investigator, with or without fever,
<br> within 72 hours prior to the prime vaccination. An acute illness which is nearly
<br> resolved with only minor residual symptoms remaining is allowable if, in the opinion
<br> of the investigator, the residual symptoms will not compromise their well-being if
<br> they participate as trial subjects in the trial, or that could prevent, limit, or
<br> confound the protocol-specified assessments.
<br>
<br> - Are breastfeeding on the day of Screening Visit or who plan to breastfeed during the
<br> trial, starting from Screening Visit and continuously until at least 90 days after the
<br> last immunization. Women or partners who plan to become pregnant within 1 year post
<br> the Screening Visit.
<br>
<br> - Have a known allergy, hypersensitivity, or intolerance to the planned vaccine for
<br> trial including any excipients.
<br>
<br> - Used to have a history of hypersensitivity or serious reactions to vaccination.
<br>
<br> - Received any vaccination within 4 weeks prior to Visit 1.
<br>
<br> - Don't agree to not be vaccinated during the trial, starting from Screening Visit and
<br> continuously until 28 days after receiving the last immunization, except emergency
<br> vaccination (e.g. rabies vaccine, tetanus vaccine).
<br>
<br> - Had any medical condition (e.g., autoimmune disease) or any major surgery (e.g.,
<br> requiring general anesthesia) within the past 5 years, which in the opinion of the
<br> investigator, could compromise their well-being if they participate as trial subjects
<br> in the trial, or that could prevent, limit, or confound the protocol-specified
<br> assessments.
<br>
<br> - Have any surgery planned during the trial, starting from Screening Visit and
<br> continuously until at least 90 days after the last immunization.
<br>
<br> - Had any chronic use (more than 14 continuous days) of any systemic medications that
<br> | | SARS-CoV-2 | Biological: BNT162b1;Other: Placebo | Occurrence of AE associated with vaccination in subjects during the 28-day period after boost dose of BNT162b1 or placebo.;Occurrence of adverse event (AE) associated with vaccination in subjects during the 21-day period after prime vaccination of BNT162b1 or placebo.;Occurrence of solicited systematic reactions (e.g., nausea, vomiting, diarrhea, headache, fatigue, myalgia, arthralgia, chills, loss of appetite, malaise, and fever) during 14-day after each dose of BNT162b1 or placebo.;Occurrence of solicited local reactions in the subjects (e.g., vaccination sites: pain/tenderness, erythema/redness, induration/swelling) during the 14-days after each dose of BNT162b1 or placebo. | | | | Yes | False | | |
| → | NCT04528667 | 8 February 2021→15 November 2021 | Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19 | A Phase 2, Randomized, Double-Blind, Placebo-controlled Study of the Safety and Efficacy of STI-5656 (Abivertinib Maleate) in Subjects Hospitalized Due to COVID-19 | | Sorrento Therapeutics, Inc. | 20/08/2020 | 20200820 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04528667 | Recruiting→Not recruiting | No | 18 Years | N/A | All | January 6, 2021 | 400→396 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | Brazil | ; ; → | Mike Royal, MD;Mike Royal, MD;Carlos Quadros, MD→Mike Royal, MD | | ;mroyal@sorrentotherapeutics.com;→ | ;858-203-4100;→ | Sorrento Therapeutics, Inc.;→Sorrento Therapeutics, Inc. |
<br> Inclusion Criteria:
<br>
<br> - Confirmed positive for COVID-19 by RT-PCR assay or equivalent
<br>
<br> - Subject or family member/caregiver must have provided written informed consent which
<br> includes signing the institutional review board (IRB) or independent ethics committee
<br> (IEC) approved consent form prior to participating in any study related activity.
<br> However, if obtaining written informed consent is not possible, other procedures as
<br> provided in the March 27, 2020 (Updated on July 2, 2020) FDA Guidance on Conduct of
<br> Clinical Trials of Medical Products during COVID-19 Pandemic, Question 10, may be used
<br>
<br> - Able to swallow capsules
<br>
<br> - Willing to follow contraception guidelines
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnant or breast feeding
<br>
<br> - Suspected uncontrolled active bacterial, fungal, viral, or other infection other than
<br> COVID-19
<br>
<br> - Treatment with a strong cytochrome p450 3A4 inhibitor or inducer within 7 days prior
<br> to Day 1
<br>
<br> - Received anti-rejection or immunomodulatory drugs within 14 days prior to Day 1
<br>
<br> - Concurrent participation in another clinical trial involving therapeutic interventions
<br> (observation studies are acceptable)
<br>
<br> - Any condition that confounds the ability to interpret data from the study
<br>
<br> - Any significant medical condition, laboratory abnormality, or psychiatric illness that
<br> would interfere with or prevent the subject from participating in the study
<br> | | Covid19 | Drug: STI-5656;Drug: Placebo | Proportion of subjects discharged from hospital | | | | Yes | False | | |
| → | NCT04530604 | 26 July 2021→15 November 2021 | Defibrotide Therapy for SARS-CoV2 (COVID-19) Acute Respiratory Distress Syndrome (ARDS) | Defibrotide Therapy for SARS-CoV2 Acute Respiratory Distress Syndrome (ARDS) | | Gregory Yanik | 25/08/2020 | 20200825 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04530604 | Not recruiting | No | 18 Years | 70 Years | All | October 1, 2020 | 12 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | United States | | Gregory Yanik, MD | | | | University of Michigan |
<br> Inclusion Criteria:
<br>
<br> - Presence of SARS-CoV2 infection, confirmed by real-time reverse transcription
<br> polymerase chain reaction (RT-PCR) assay from a nasopharyngeal swab specimen or other
<br> diagnostic test for SARS-CoV2.
<br>
<br> - Serum D-Dimer = 2.0 mcg/ml.
<br>
<br> - Patients with Acute Respiratory Distress Syndrome (ARDS) as determined by the
<br> following criteria (Berlin criteria adaptation):
<br>
<br> - Radiographic evidence of bilateral lung disease (opacities or ground glass
<br> opacification) on chest radiograph (CXR) or computed tomography (CT), and the
<br> opacities not fully explained by pleural effusions, cardiac failure or fluid
<br> overload.
<br>
<br> - Impairment of oxygenation, as defined by the ratio of arterial oxygen tension to
<br> fraction of inspired oxygen (PaO2/FiO2) = 300 mmHg (millimeters of mercury).
<br>
<br> - Patients must provide voluntary written informed consent to be eligible for study. For
<br> patients who are medically unable to provide consent, their designated proxy or legal
<br> guardian will provide informed consent. The consenting process is described in
<br> Appendix II.
<br>
<br> - Patients actively participating in another clinical trial for the management of
<br> SARS-CoV2 are eligible provided those trials do not directly involve an anti-platelet,
<br> anti-coagulant or anti-fibrinolytic agent. (Patients enrolled on investigational
<br> trials utilizing anti-viral specific agents, cytokine inhibitors, tyrosine kinase
<br> inhibitors, or other anti-inflammatory agents are still eligible).
<br>
<br> Exclusion Criteria:
<br>
<br> - Concomitant use of heparin, systemic anticoagulants, and/or fibrinolytics are not
<br> permitted within 12 hours, with the exception of heparin flushes for centrally placed
<br> catheters, fibrinolytic instillation for central venous line occlusion, or in the
<br> in-flow circuit for patients on continuous veno-venous hemodialysis.
<br>
<br> - Clinically significant acute bleeding, including (but not limited to one of the
<br> following): pulmonary hemorrhage (diffuse alveolar hemorrhage), intracranial bleed,
<br> gastro-intestinal hemorrhage (gross hematemesis or hematochezia), gross hematuria or
<br> uncontrolled epistaxis irrespective of the amount of blood loss, within the prior 3
<br> days.
<br>
<br> - On mechanical ventilation for > 96 consecutive hours.
<br>
<br> - Serum platelet count < 50,000/Microliters (uL). Transfusion of platelets to achieve a
<br> level > 50,000/uL is not allowed for eligibility.
<br>
<br> - Serum fibrinogen < 150 mg/dl. Transfusion of fresh frozen plasma or cryoprecipitate to
<br> achieve a level > 150 mg/dl is not allowed for eligibility.
<br>
<br> - Positive blood culture for a bacterial pathogen within the prior 24 hours prior to
<br> study entry, and/or the presence of bacterial pneumonia.
<br>
<br> - Hemodynamic instability as defined by a requirement for 2 or more vasopressors (not
<br> including renal-doses of dopamine).
<br>
<br> - Concurrent use of Extracorporeal membrane oxygenation (ECMO).
<br>
<br> - Patients with a previously known hypersensitivity reaction to defibrotide, or any of
<br> its excipients.
<br>
<br> - Females who are pregnant or breastfeeding.
<br>
<br> - History of cerebrovascular accident (i.e. thrombotic or hemorrhagic stroke) within 3
<br> months prior to study entry.
<br> | | COVID;Sars-CoV2;COVID-19;Acute Respiratory Distress Syndrome | Drug: Defibrotide | Number of major hemorrhagic complications within 14 days of initiation of treatment | | | | Yes | False | | |
| → | NCT04540939 | 12 December 2020→15 November 2021 | Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD) - COVID Related Substudy | Neural Mechanisms of Mindfulness-based Cognitive Therapy (MBCT) for Posttraumatic Stress Disorder (PTSD) - COVID Related Substudy | | University of Michigan | 04/09/2020 | 20200904 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04540939 | Recruiting | No | 18 Years | 72 Years | All | October 19, 2020 | 60 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Investigator, Outcomes Assessor). | N/A | United States | ; ; → ; ; ; | Anthony King, Ph.D.;Jung Park;Jung Park→Anthony King, Ph.D.;David Fresco, PhD;Jung Park;Jung Park | | ;jungp@med.umich.edu;jungp@umich.edu→;;jungp@med.umich.edu;jungp@umich.edu | ;734-615-5249;734-615-5249→;;734-615-5249;734-615-5249 | University of Michigan;→University of Michigan;University of Michigan; |
<br> Inclusion Criteria:
<br>
<br> - COVID distress sample: resides in geographical area heavily impacted by COVID-19 have
<br> a history of trauma
<br>
<br> - Has current elevated levels of COVID related stress and/or distress (worry, repetitive
<br> negative thinking) (COVID stress scale score > 15, worry / repetitive negative
<br> thinking, Penn State Worry Questionnaire (PSWQ) score >35 ).
<br>
<br> Exclusion Criteria:
<br>
<br> - Dissociative PTSD
<br>
<br> - Delayed-onset PTSD
<br>
<br> - Suicide risk
<br>
<br> - Psychosis
<br>
<br> - Life history of schizophrenia
<br>
<br> - Life history of bipolar disorder
<br>
<br> - Current substance dependence
<br>
<br> - Other factors that preclude safe and meaningful participation in the study, at
<br> discretion of the PI and study team
<br> →
<br> Inclusion Criteria:
<br>
<br> - COVID distress sample: resides in geographical area heavily impacted by COVID-19 have
<br> a history of trauma
<br>
<br> - Has current elevated levels of COVID related stress and/or distress (worry, repetitive
<br> negative thinking) (COVID stress scale score > 15, worry / repetitive negative
<br> thinking, Penn State Worry Questionnaire (PSWQ) score >35 ).
<br>
<br> Exclusion Criteria:
<br>
<br> - PTSD
<br>
<br> - Suicide risk
<br>
<br> - Psychosis
<br>
<br> - Life history of schizophrenia
<br>
<br> - Current substance dependence
<br>
<br> - Other factors that preclude safe and meaningful participation in the study, at
<br> discretion of the PI and study team
<br> | | Trauma | Behavioral: Mindfulness-Based Cognitive Therapy;Behavioral: Muscle Relaxation Therapy | Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey;Penn State Worry Questionnaire (PSWQ-16) Worry survey;PROMIS (adult short form) Emotional Depression survey;Working Alliance Inventory- short revised (WAI-SR)→Working Alliance Inventory- short revised (WAI-SR);PROMIS (adult short form) Emotional Depression survey;Penn State Worry Questionnaire (PSWQ-16) Worry survey;Patient-Reported Outcomes Measurement Information System (PROMIS-adult short form level 2) Anxiety survey | | | | Yes | False | | |
| → | NCT04542083 | 2 August 2021→15 November 2021 | Covid-19, Acute Myocardial Infarctions and Strokes in France | Impact of COVID-19 on Unplanned Admissions for Acute Cardiovascular and Neurovascular Conditions in France | COVUSI | University Hospital, Montpellier | 04/09/2020 | 20200904 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04542083 | Not recruiting→Recruiting | No | 18 Years | N/A | All | September 20, 2021 | 4000 | Observational | | | France | ; ; | Grégoire Mercier, PU PH;Grégoire Mercier, PU PH;Grégoire MERCIER, PUPH | | ;g-mercier@chu-montpellier.fr;g-mercier@chu-montpellier.fr | ;4 67 33 91 09;4 67 33 91 09 | University Hospital, Montpellier; |
<br> Inclusion criteria:
<br>
<br> - Adults admitted in 2018, 2019 or 2020 in a French hospital for acute coronary syndrom or
<br> stroke
<br>
<br> Exclusion criteria:
<br>
<br> - None
<br> | | COVID-19;Acute Cardiovascular Condition;Acute Neurovascular Condition;Stroke;Acute Myocardial Infarction | | Daily number of admissions for acute cardio- and neurivascular conditions in France. | | | | Yes | False | | |
| → | NCT04546737 | 20 September 2021→15 November 2021 | Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients | Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients | NSpectroCovid | Centre Hospitalier Universitaire, Amiens | 10/09/2020 | 20200910 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04546737 | Recruiting→Not recruiting | No | 18 Years | N/A | All | September 8, 2020 | 20 | Interventional | Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). | N/A | France | ; → | Jean-Marc CONSTANS, Pr;Jean-Marc Constans, Pr→ | | constans.jean-marc@chu-amiens.fr;constans.jean-marc@chu-amiens.fr→ | (33)32266087511;03.22.6608.75.11→ | |
<br> Inclusion Criteria:
<br>
<br> - Major COVID-19 patient (=18 years old)
<br>
<br> - COVID-19 patient presenting at least one the neurological manifestations:
<br>
<br> anosmia, ageusia, periorbital pain, dizziness, fatigue, moderate headache, moderate memory
<br> and behavioral disorders.
<br>
<br> - Patient who have signed an informed consent form for the study
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient under guardianship or curators or under judicial protection
<br>
<br> - Pregnant and breastfeeding women
<br> | | Covid19;Neurological Manifestations;Brain Damage | Other: Magnetic Resonance Spectroscopy (MRS). | Variation from baseline of MRI radiological semiology in COVID-19 patients | | | | Yes | False | | |
| → | NCT04547140 | 18 October 2021→15 November 2021 | Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) in Hospitalized Participants With Coronavirus Disease (COVID-19) | A Multicenter, Randomized, Double-blind, Placebo-Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Liquid Alpha1-Proteinase Inhibitor (Human) Plus Standard Medical Treatment (SMT) Versus Placebo Plus SMT in Hospitalized Subjects With COVID-19 | | Grifols Therapeutics LLC | 10/09/2020 | 20200910 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04547140 | Recruiting | No | 18 Years | N/A | All | January 29, 2021 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | United States;Colombia;Chile;Brazil;Colombia;Chile;Brazil;United States→United States;Brazil;Chile;Colombia;Mexico;United States;Mexico;Colombia;Chile;Brazil | | Rhonda Griffin | | Rhonda.Griffin@grifols.com | 919-316-6693 | |
<br> Inclusion Criteria:
<br>
<br> 1. Hospitalized male or female subject = 18 years of age at time of screening who is
<br> being treated for COVID-19. Subjects must be screened within 48 hours (= 48 hours) of
<br> hospital admission.
<br>
<br> 2. Has laboratory-confirmed novel coronavirus {SARS-CoV-2} infection as determined by
<br> qualitative polymerase chain reaction (PCR) (reverse transcriptase [RT]-PCR), or other
<br> commercial or public health assay approved by regulatory authorities as a diagnostic
<br> test for COVID-19 in any specimen during the current hospital admission OR 96 hours
<br> prior to the hospital admission date and prior to randomization (the SARS-CoV-2 test
<br> results must be performed by a hospital laboratory and the documentation available).
<br>
<br> 3. COVID-19 illness (symptoms) of any duration, including both of the following: a)
<br> Radiographic infiltrates by imaging (chest X-Ray, computed tomography (CT) scan, etc.)
<br> and/or clinical assessment (evidence of rales/crackles on exam) with peripheral oxygen
<br> saturation by pulse oximetry (SpO2) <94% on room air; b) Any one of the following
<br> related to COVID-19: i. Ferritin > 400 nanogram per milliliter (ng/mL), ii. lactate
<br> dehydrogenase (LDH) > 300 units per liter (U/L), iii. D-Dimers > reference range, or
<br> iv. C-reactive protein (CRP) > 40 milligram per liter (mg/L).
<br>
<br> 4. Subject provides informed consent prior to initiation of any study procedures.
<br>
<br> 5. Female subjects of childbearing potential (and males with female partners of
<br> childbearing potential) must agree to use of acceptable contraception methods during
<br> study (example, oral, injectable, or implanted hormonal methods of contraception,
<br> placement of an intrauterine device or intrauterine system, condom or occlusive cap
<br> with spermicidal foam/gel/film/cream/suppository, male sterilization, or true
<br> abstinence) throughout the study.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subjects requiring invasive mechanical ventilation or ICU admission or with partial
<br> pressure of arterial oxygen/ fraction of inspired oxygen (PaO2/FIO2) = 150 mmHg (i.e.,
<br> arterial oxygen in millimeter of mercury (mmHg) divided by fraction inspired oxygen
<br> concentration [example, 0.21 for room air]).
<br>
<br> 2. Clinical evidence of any significant acute or chronic disease that, in the opinion of
<br> the investigator, may place the subject at undue medical risk.
<br>
<br> 3. The subject has had a known serious anaphylactic reaction to blood, any blood-derived
<br> or plasma product, or known selective immunoglobulin A (IgA) deficiency with anti-IgA
<br> antibodies.
<br>
<br> 4. A medical condition in which the infusion of additional fluid is contraindicated
<br> (example, decompensated congestive heart failure or renal failure with fluid
<br> overload). This includes currently uncontrolled congestive heart failure New York
<br> Heart Association Class III or IV stage heart failure.
<br>
<br> 5. Shock that is unresponsive to fluid challenge and/or multiple vasopressors and
<br> accompanied by multiorgan failure considered not able to be reversed by the Principal
<br> Investigator.
<br>
<br> 6. Known alpha-1 antitrypsin deficiency for which the subject is already receiving
<br> alpha1-proteinase inhibitor augmentation therapy.
<br>
<br> 7. Women who are pregnant or breastfeeding. Female subjects of child-bearing potential
<br> must have a negative test for pregnancy blood or urine human chorionic gonadotropin
<br> (HCG)-based assay at screening/baseline visit.
<br>
<br> 8. Subjects for whom there is limitation of therapeutic effort such as "Do not
<br> resuscitate" status.
<br>
<br> 9. Currently participating in another interventional clinical trial with investigational
<br> medical product or device.
<br>
<br> 10. Subjects previously requiring long-term oxygen therapy (home oxygen therapy).
<br>
<br> 11. History (within the last 2 years) of myocardial infarction, unstable angina, stroke or
<br> transient ischemic attacks, pulmonary embolism or deep venous thrombosis
<br>
<br> 12. Subject has medical condition (other than COVID-19) that is projected to limit
<br> lifespan to = 1 year
<br>
<br> 13. Systolic blood pressure < 100 mm Hg or > 160 mm Hg (uncontrolled hypertension) at the
<br> time of Screening
<br>
<br> 14. Alanine aminotransferase (ALT) = 2 times the upper limit of normal (ULN)
<br>
<br> 15. Any elevation of total bilirubin at the time of Screening
<br>
<br> 16. Estimated glomerular filtration rate (eGFR) < 45 mL/min (or subject is dependent on
<br> dialysis/renal replacement therapy) at the time of Screening
<br>
<br> 17. Hemoglobin < 10 g/dL at the time of Screening
<br>
<br> 18. Absolute neutrophil count < 1000/mm3 at the time of Screening
<br>
<br> 19. Platelet count < 75,000/mm3 at the time of Screening
<br>
<br> 20. Subject has history of drug or alcohol abuse within the past 24 months
<br>
<br> 21. Subject is unwilling to commit to follow-up visits
<br>
<br> 22. Known history of prothrombin gene mutation 20210, homozygous Factor V Leiden
<br> mutations, antithrombin III deficiency, protein C deficiency, protein S deficiency or
<br> antiphospholipid syndrome
<br> | | COVID-19 | Biological: Liquid Alpha1-Proteinase Inhibitor (Human);Drug: Placebo;Drug: Standard Medical Treatment | Percentage of Participants Who are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation;Percentage of Participants Dying or Requiring ICU Admission→Percentage of Participants Dying or Requiring ICU Admission;Percentage of Participants Who are Dependent on High Flow Oxygen Devices or Invasive Mechanical Ventilation | | | | Yes | False | | |
| → | NCT04558320 | 17 May 2021→15 November 2021 | COVID-19 and Lactating Mothers | COVID-19 and Lactating Mothers | | University of Rochester | 19/09/2020 | 20200919 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04558320 | Not recruiting | No | N/A | N/A | All | July 2, 2020 | 100→76 | Observational | | | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Currently lactating mother:
<br>
<br> - English-speaking
<br>
<br> - greater than or equal to 18 years of age
<br>
<br> - Assigned female at birth (AFAB)
<br>
<br> - Having a positive COVID-19 test within 14 days
<br>
<br> - Child:
<br>
<br> - Infants younger than or equal to 6 months of age, exclusively or partially human
<br> milk fed, sourced from mother. Infants who are fed both directly at the breast
<br> and exclusively fed mother's milk via bottle will be included
<br>
<br> Exclusion Criteria:
<br>
<br> - Non-English speaking
<br> | | Coronavirus Infection | | mean change in SARS-Cov-2 viral load in breast milk | | | | Yes | False | | |
| → | NCT04568499 | 12 April 2021→15 November 2021 | Presenting Nutrition Characteristics, Comorbidities and Outcomes of COVID-19 in African Humanitarian Settings | Presenting Nutrition Characteristics, Comorbidities and Outcomes of COVID-19 in African Humanitarian Settings: a Prospective Cohort Study in South Sudan and DRC | | Johns Hopkins Bloomberg School of Public Health | 24/09/2020 | 20200924 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04568499 | Recruiting→Not recruiting | No | 5 Years | N/A | All | November 27, 2020 | 1000→592 | Observational | | | South Sudan;Congo, The Democratic Republic of the;South Sudan;Congo, The Democratic Republic of the | ; → | Shannon Doocy, PhD;Shannon Doocy, PhD→Shannon Doocy, PhD | | ;doocy1@jhu.edu→ | ;4102154841→ | Johns Hopkins Bloomberg School of Public Health;→Johns Hopkins Bloomberg School of Public Health |
<br> Inclusion Criteria:
<br>
<br> - Suspected, probable, and confirmed COVID-19 cases presenting for care at participating
<br> health facilities (either by walk-in, referral or transfer) or identified by mobile
<br> contact tracing teams.
<br>
<br> Exclusion Criteria:
<br>
<br> - Individuals unable or unwilling to give informed consent (e.g., due to mental
<br> impairment)
<br> | | COVID-19 | | Mortality;Hospitalization | | | | Yes | False | | |
| → | NCT04569344 | 2 August 2021→15 November 2021 | COVID-19 and Venous Thromboembolism Risk | COVID-19 and Venous Thromboembolism Risk | | University of California, San Francisco | 25/09/2020 | 20200925 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04569344 | Recruiting→Not recruiting | No | 18 Years | N/A | All | January 1, 2020 | 40000→398530 | Observational | | | United States | | Margaret C Fang, MD | | | | University of California, San Francisco |
<br> Inclusion
<br>
<br> - Covid-19 diagnosis (defined as date of a positive laboratory test for SARS-CoV-2
<br> virus) during the time period January 1, 2020 to December 31, 2020
<br>
<br> - Age >=18 years
<br>
<br> - Continuous pharmacy benefits and health plan membership for at least 12 months before
<br> the index date
<br>
<br> Exclusion
<br>
<br> • incomplete information on age and sex
<br> →
<br> Inclusion
<br>
<br> - Covid-19 diagnosis (defined as date of a positive laboratory test for SARS-CoV-2
<br> virus) during the time period January 1, 2020 to January 31, 2021
<br>
<br> - Age >=18 years
<br>
<br> - Continuous pharmacy benefits and health plan membership for at least 12 months before
<br> the index date
<br>
<br> Exclusion
<br>
<br> • incomplete information on age and sex
<br> | | Venous Thromboembolism;Covid19 | Other: Laboratory test positive for SARS-CoV-2 virus | Acute venous thromboembolism (VTE);Death | | | | Yes | False | | |
| → | NCT04569383 | 12 December 2020→15 November 2021 | Safety, Tolerability and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S Against COVID-19→Safety and Immunogenicity of the Candidate Vaccine MVA-SARS-2-S and a Booster Vaccination With a Licensed Vaccine Against COVID-19 | An Open, Single-center Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-SARS-2-S→An Open, Single-center Phase I Trial to Assess the Safety, Tolerability and Immunogenicity of Two Ascending Doses of the Candidate Vaccine MVA-SARS-2-S and Heterologous Booster Vaccinations With a Licensed Vaccine Against COVID-19 | | Universitätsklinikum Hamburg-Eppendorf | 21/09/2020 | 20200921 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04569383 | Recruiting→Not recruiting | No | 18 Years | 55 Years | All | October 5, 2020 | 30 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1 | Germany | ; → | Marylyn M Addo, MD;Marylyn M Addo, MD→Marylyn M Addo, MD | | ;m.addo@uke.de→ | ;+49 407410→ | Universitätsklinikum Hamburg-Eppendorf;→Universitätsklinikum Hamburg-Eppendorf |
<br> Inclusion Criteria:
<br>
<br> - Written informed consent
<br>
<br> - Healthy male and female adults aged 18-55 years
<br>
<br> - No clinically significant health problems as determined during medical history and
<br> physical examination at screening visit
<br>
<br> - Body mass index 18.5 - 30.0 kg/m2 and weight > 50 kg at screening
<br>
<br> - Adults male or non-pregnant, non-lactating female with negative pregnancy test
<br>
<br> - Males and females who agree to comply with the applicable contraceptive requirements
<br> of the protocol
<br>
<br> Exclusion Criteria:
<br>
<br> - Prior exposure to SARS-CoV-2
<br>
<br> - Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live
<br> vaccines) to 6 weeks after each trial vaccination
<br>
<br> - Previous rMVA immunization
<br>
<br> - Known allergy to the components of the SARS-CoV-2 vaccine product
<br>
<br> - Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by
<br> any component of the trial vaccine
<br>
<br> - Evidence in the subject's medical history or in the medical examination that might
<br> influence either the safety of the subject or the absorption, distribution, metabolism
<br> or excretion of the investigational product
<br>
<br> - Clinically relevant findings in ECG
<br>
<br> - Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic
<br> therapy in the previous 5 years, and/or diabetes
<br>
<br> - Any chronic or active neurologic disorder, including seizures, and epilepsy, excluding
<br> a single febrile seizure as a child
<br> →
<br> Inclusion Criteria:
<br>
<br> - Written informed consent
<br>
<br> - Healthy male and female adults aged 18-55 years
<br>
<br> - No clinically significant health problems as determined during medical history and
<br> physical examination at screening visit
<br>
<br> - Body mass index 18.5 - 30.0 kg/m2 and weight > 50 kg at screening
<br>
<br> - Adults male or non-pregnant, non-lactating female with negative pregnancy test
<br>
<br> - Males and females who agree to comply with the applicable contraceptive requirements
<br> of the protocol
<br>
<br> Inclusion criteria for the subjects before the 3rd/4th (=booster) vaccination:
<br>
<br> 1. Ability to understand the subject information and to personally name, sign and date
<br> the in-formed consent to participate in the study.
<br>
<br> 2. Provided written informed consent.
<br>
<br> 3. Continues to be in stable health condition as determined during medical history and
<br> physi-cal examination on vaccination visits.
<br>
<br> 4. Non-pregnant, non-lactating female with a negative pregnancy test at screening and on
<br> dosing days (prior to vaccination).
<br>
<br> 5. Be willing to refrain from blood donation during the course of the study.
<br>
<br> 6. The subject is co-operative and available for the entire study.
<br>
<br> 7. Need to have participated in previous part of the MVA-SARS-2-S vaccine study (Eudra-CT
<br> No: 2020-002998-10)
<br>
<br> Exclusion Criteria:
<br>
<br> - Prior exposure to SARS-CoV-2
<br>
<br> - Receipt of any vaccine from 4 weeks prior to each trial vaccination (8 weeks for live
<br> vaccines) to 6 weeks after each trial vaccination
<br>
<br> - Previous rMVA immunization
<br>
<br> - Known allergy to the components of the SARS-CoV-2 vaccine product
<br>
<br> - Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by
<br> any component of the trial vaccine
<br>
<br> - Evidence in the subject's medical history or in the medical examination that might
<br> influence either the safety of the subject or the absorption, distribution, metabolism
<br> or excretion of the investigational product
<br>
<br> - Clinically relevant findings in ECG
<br>
<br> - Any confirmed or suspected immunosuppressive or immunodeficient condition, cytotoxic
<br> therapy in the previous 5 years, and/or diabetes
<br>
<br> - Any chronic or active neurologic disorder, including seizures, and epilepsy, excluding
<br> a single febrile seizure as a child
<br>
<br> Exclusion criteria for the subjects before the 3rd/4th (=booster) vaccination:
<br>
<br> 1. Prior infection with SARS-CoV-2 in medical history (documented by PCR test)
<br>
<br> 2. Receipt of any vaccine from 2 weeks prior to each trial vaccination (4 weeks for live
<br> vac-cines) to 2 weeks after each trial vaccination.
<br>
<br> 3. Receipt any COVID-19 vaccine (investigational or licensed other than MVA-SARS-2-S
<br> be-fore vaccination throughout end of study).
<br>
<br> 4. Known allergy to the components of t Comirnaty®.
<br>
<br> 5. Known history of anaphylaxis to vaccination or any allergy likely to be exacerbated by
<br> any component of the trial vaccine.
<br>
<br> 6. Participation in a clinical trial other than the MVA-SARS-2-S vaccine trial or use of
<br> an in-vestigational product other than MVA-SARS-2-S within 30 days or five times the
<br> half-life of the investigational product -whichever is longer- prior to receiving the
<br> first dose within this study.
<br>
<br> 7. Evidence in the subject's medical history or in the medical examination that might
<br> influence
<br> | | Covid19 | Biological: MVA-SARS-2-S vaccinations (days 0 & 28)→Biological: MVA-SARS-2-S vaccinations (days 0 & 28);Biological: Comirnaty | Percentage of Participants Experiencing Solicited Local or Systemic Reactogenicity as Defined by the Study Protocol | | | | Yes | False | | |
| → | NCT04575597 | 18 October 2021→15 November 2021 | Efficacy and Safety of Molnupiravir (MK-4482) in Non-Hospitalized Adult Participants With COVID-19 (MK-4482-002) | A Phase 2/3, Randomized, Placebo-Controlled, Double-Blind Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MK-4482 in Non-Hospitalized Adults With COVID-19. | | Merck Sharp & Dohme Corp. | 30/09/2020 | 20200930 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04575597 | Not recruiting | Yes | 18 Years | N/A | All | October 19, 2020 | 1850 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2/Phase 3 | United States;Argentina;Brazil;Canada;Chile;Colombia;Egypt;France;Germany;Guatemala;Israel;Italy;Japan;Mexico;Philippines;Poland;Russian Federation;South Africa;Spain;Sweden;Taiwan;Ukraine;United Kingdom;Argentina;Brazil;Canada;Chile;Colombia;Egypt;France;Germany;Guatemala;Israel;Italy;Japan;Mexico;Philippines;Poland;Russian Federation;South Africa;Spain;Sweden;Taiwan;Ukraine;United Kingdom;United States→Brazil;Canada;Chile;Colombia;Egypt;France;Germany;Guatemala;Israel;Italy;Japan;Mexico;Philippines;Poland;Russian Federation;South Africa;Spain;Sweden;Taiwan;Ukraine;United Kingdom;United States;Argentina;United Kingdom;Ukraine;Taiwan;Sweden;Spain;South Africa;Russian Federation;Poland;Philippines;Mexico;Japan;Italy;Israel;Guatemala;Germany;France;Egypt;Colombia;Chile;Canada;Brazil;Argentina;United States | | Medical Director | | | | Merck Sharp & Dohme Corp. |
<br> Inclusion Criteria:
<br>
<br> - Has documentation of laboratory confirmed severe acute respiratory syndrome
<br> coronavirus 2 (SARS-CoV-2) infection with sample collection =5 days prior to the day
<br> of randomization. PCR is the preferred method; however with evolving approaches to
<br> laboratory confirmation of SARS-CoV-2 infection, other molecular or antigen tests that
<br> detect viral ribonucleic acid (RNA) or protein are allowed if authorized for use in
<br> the country. Serological tests that detect host antibodies generated in response to
<br> recent or prior infection are not allowed.
<br>
<br> - Had initial onset of signs/symptoms attributable to COVID-19 for =5 days prior to the
<br> day of randomization and at least 1 of the following sign/symptom attributable to
<br> COVID-19 on the day of randomization.
<br>
<br> - Has mild or moderate COVID-19.
<br>
<br> - Has at least 1 characteristic or underlying medical condition associated with an
<br> increased risk of severe illness from COVID-19.
<br>
<br> - Males agree to the following during the intervention period and for at least 4 days
<br> after the last dose of study intervention: Either abstain from heterosexual
<br> intercourse as their preferred and usual lifestyle (abstinent on a long term and
<br> persistent basis) and agree to remain abstinent; or must agree to use contraception.
<br>
<br> - Females are not pregnant or breastfeeding, and at least one of the following
<br> conditions applies: Is not a woman of child bearing potential (WOCBP); or is a WOCBP
<br> and using a contraceptive method that is highly effective (a low user dependency
<br> method OR a user dependent method in combination with barrier method), or be abstinent
<br> from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a
<br> long-term and persistent basis) for at least 4 days after the last dose of study
<br> intervention; a WOCBP must have a negative highly sensitive pregnancy test (urine or
<br> serum test is required) within 24 hours before the first dose of study intervention.
<br>
<br> Exclusion Criteria:
<br>
<br> - Is currently hospitalized or is expected to need hospitalization for COVID-19 within
<br> 48 hours of randomization.
<br>
<br> - Is on dialysis or has reduced estimated glomerular filtration rate (eGFR) <30
<br> mL/min/1.73m^2 by the Modification of Diet in Renal Disease (MDRD) equation.
<br>
<br> - Has any of the following conditions: human immunodeficiency virus (HIV) with a recent
<br> viral load >50 copies/mL (regardless of CD4 count) or an AIDS-defining illness in the
<br> past 6 months, participants with HIV may only be enrolled if on a stable
<br> antiretroviral therapy regimen; a neutrophilic granulocyte absolute count <500/mm^3.
<br>
<br> - Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) with cirrhosis,
<br> end-stage liver disease, hepatocellular carcinoma, aspartate aminotransferase (AST)
<br> and/or alanine aminotransferase (ALT) >3X upper limit of normal at screening.
<br>
<br> - Has a platelet count <100,000/µL or received a platelet transfusion in the 5 days
<br> prior to randomization.
<br>
<br> - Is taking or is anticipated to require any prohibited therapies.
<br>
<br> - Is unwilling to abstain from participating in another interventional clinical study
<br> through Day 29 with an investigational compound or device, including those for
<br> COVID-19 therapeutics.
<br>
<br> - Has hypersensitivity or other contraindication to any of the components of the study
<br> interventions as determined by the investigator.
<br>
<br> - Has any condition for which, in the opinion of the investigator, participation would
<br> not be in the best interest of the participant or that could prevent, limit, or
<br> confound the protocol-specified assessments including but not limited to: participants
<br> who are not expected to survive longer than 48 hours after randomization, or
<br> participants with a recent history of mechanical ventilation, or participants with
<br> conditions that could limit gastrointestinal absorption of capsule contents.
<br> | | Coronavirus Disease (COVID-19) | Drug: Molnupiravir;Drug: Placebo | Percentage of participants who are hospitalized and/or die;Percentage of participants with an adverse event (AE);Percentage of participants who discontinued study intervention due to an AE→Percentage of participants who discontinued study intervention due to an AE;Percentage of participants with an adverse event (AE);Percentage of participants who are hospitalized and/or die | | | | Yes | True | parent | |
| → | NCT04581096 | 12 December 2020→15 November 2021 | Mapping COVID-19 Spread in a Tertiary Hospital | Evaluation of the Response of COVID-19 Spread With a Spatiotemporal Analysis in a Tertiary Hospital | MEDyMAP | Hospital General Universitario de Valencia | 07/10/2020 | 20201007 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04581096 | Recruiting→Not recruiting | No | 18 Years | 100 Years | All | October 2, 2020 | 3000→2646 | Observational [Patient Registry] | | | Spain | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - positive test (PCR or serology) for SARS-CoV-2
<br>
<br> - outpatient follow-up
<br>
<br> Exclusion Criteria:
<br>
<br> - hospitalisation in ward or ICU
<br> | | Covid19;Spatial Visualization;Neural Network;Respiratory Disease;Pandemic;Disease Spread | Other: no intervention | spatiotemporal spread | | | | Yes | False | | |
| → | NCT04583319 | 24 August 2021→15 November 2021 | Validation of a Rapid, Non-invasive Point-of-care IVD Test for Diagnosis of SARS-COV-2 (COVID-19) Infection | A Prospective, Non-interventional Study for Validation of a Rapid, Non-invasive IVD as a Point-of-care Test for Diagnosis of SARS-COV-2 Infection | EasyCov | Firalis SA | 30/09/2020 | 20200930 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04583319 | Recruiting | No | 18 Years | N/A | All | December 12, 2020 | 160 | Observational | | | Turkey | ; ; | Arif Atahan, Prof.MD;Rodwell Mkhwananzi, MD;Selçuk Sen | | ;rodwell.mkhwananzi@firalis.com; | ;+33 38 99 11 328; | Istanbul University Istanbul Faculty of Medicine (ITF), Turkey; |
<br> Inclusion Criteria:
<br>
<br> Non-specific inclusion criteria:
<br>
<br> 1. Participant aged 18 and above
<br>
<br> 2. Participant agreeing to follow the study procedures
<br>
<br> 3. Participant able to understand the purpose, nature and methodology of the study
<br>
<br> 4. Participant having signed the informed consent
<br>
<br> Specific inclusion criteria:
<br>
<br> SARS-COV-2 positive patients - Participants tested positive for the SARS-COV-2 by the
<br> routine Turkish MOH and FDA approved RT-PCR method.
<br>
<br> SARS-COV-2 negative controls
<br>
<br> - Participants tested negative for the SARS-COV-2 by the routine Turkish MOH and FDA
<br> approved RT-PCR method.
<br>
<br> Exclusion Criteria:
<br>
<br> - Minors, persons deprived of their liberty, protected adults or vulnerable persons.
<br>
<br> - Refusal to sign the consent.
<br> | | SARS-CoV | Diagnostic Test: EasyCov POC | Positive percent agreement (PPA) | | | | Yes | False | | |
| → | NCT04583956 | 1 November 2021→15 November 2021 | ACTIV-5 / Big Effect Trial (BET-A) for the Treatment of COVID-19 | A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults | | National Institute of Allergy and Infectious Diseases (NIAID) | 09/10/2020 | 20201009 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04583956 | Not recruiting | No | N/A | N/A | All | October 14, 2020 | 167 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Admitted to a hospital with symptoms suggestive of Coronavirus Disease 2019 (COVID-19)
<br> and requires ongoing medical care.
<br>
<br> 2. Subject (or legally authorized representative) provides informed consent prior to
<br> initiation of any study procedures.
<br>
<br> 3. Subject (or legally authorized representative) understands and agrees to comply with
<br> planned study procedures.
<br>
<br> 4. Male or non-pregnant female adult >/= 18 years of age at time of enrollment.
<br>
<br> 5. Illness of any duration and has laboratory-confirmed severe acute respiratory syndrome
<br> coronavirus 2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR)
<br> or other commercial or public health assay (e.g., Nucleic Acid Amplification Test
<br> [NAAT], antigen test) in any respiratory specimen or saliva </=14 days prior to
<br> randomization.
<br>
<br> 6. Illness of any duration, and requiring, just prior to randomization, supplemental
<br> oxygen (any flow), mechanical ventilation or ECMO (ordinal score 5, 6, or 7).
<br>
<br> 7. Women of childbearing potential must agree to either abstinence or use at least one
<br> acceptable method of contraception from the time of screening through 5 months post
<br> study IP dosing.
<br>
<br> Note: Acceptable methods include barrier contraceptives (condoms or diaphragm) with
<br> spermicide, intrauterine devices (IUDs), hormonal contraceptives, oral contraceptive
<br> pills, and surgical sterilization.
<br>
<br> 8. Agrees not to participate in another blinded clinical trial (both pharmacologic and
<br> other types of interventions) for the treatment of COVID-19 through Day 29.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper
<br> limit of normal.
<br>
<br> 2. Subjects with a low glomerular filtration rate (eGFR), specifically:
<br>
<br> 1. Subjects with an a glomerular filtration rate (eGFR) 20-30 mL/min are excluded
<br> unless in the opinion of the principal investigator (PI), the potential benefit
<br> of participation outweighs the potential risk of study participation.
<br>
<br> 2. All subjects with an a glomerular filtration rate (eGFR) <20 mL/min (including
<br> hemodialysis and hemofiltration) are excluded.
<br>
<br> 3. Pregnancy or breast feeding.
<br>
<br> 4. Anticipated discharge from the hospital or transfer to another hospital which is not a
<br> study site within 72 hours of enrollment.
<br>
<br> 5. Allergy to any study medication.
<br>
<br> 6. Received five or more doses of remdesivir prior to screening.
<br>
<br> 7. Received two or more doses of > 60 mg of prednisone or equivalent in the 7 days prior
<br> to screening.
<br>
<br> 8. Received small molecule tyrosine kinase inhibitors, including Janus kinase (JAK)
<br> inhibitors (e.g., baricitinib, ibrutinib, acalabrutinib, imatinib, gefitinib), in the
<br> 4 weeks prior to screening.
<br>
<br> 9. Received monoclonal antibodies targeting cytokines (e.g., tumor necrosis factor (TNF)
<br> inhibitors, anti-IL-1 [e.g., anakinra, canakinumab], anti-IL-6 [e.g., tocilizumab,
<br> sarilumab, sitlukimab]), or T-cells (e.g., abatacept) in the 4 weeks prior to
<br> screening.
<br>
<br> 10. Received monoclonal antibodies targeting B-cells (e.g., rituximab, and including any
<br> targeting multiple cell lines including B-cells) in the 3 months prior to screening.
<br>
<br> 11. Received Granulocyte-macrophage colony-stimulating factor (GM-CSF) agents (e.g.,
<br> sargramostim) within 2 months prior to screening.
<br>
<br> 12. Received other immunosuppressants in the 4 weeks prior to screening and in the
<br> judgment of the investigator, the risk of immunosuppression with risankizumab is
<br> larger than the risk of Coronavirus Disease 2019 (COVID-19).
<br>
<br> 13. Received any live vaccine in the 4 weeks prior to screening.
<br>
<br> 14. Known active tuberculosis.
<br>
<br> 15. Known history of Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or untreated
<br> hepatitis C (HCV) infection.
<br>
<br> 16. History of pulmonary alveolar proteinosis (PAP).
<br>
<br> 17. Has a malignancy and currently receiving immunosuppressive chemotherapy,
<br> immunodeficiency, uncontrolled opportunistic infection, or uncontrolled cirrhosis.
<br>
<br> 18. Has a medical condition that could, in the judgment of the investigator, limit the
<br> interpretation and generalizability of trial results.
<br>
<br> 19. Positive test for influenza virus during the current illness (influenza testing is not
<br> required by protocol).
<br>
<br> 20. Previous participation in an ACTIV-5/Big Effect Trial (BET)
<br> | | COVID-19 | Other: Placebo;Drug: Remdesivir;Biological: Risankizumab | Clinical status on an 8-point ordinal scale. | | | | Yes | False | | |
| → | NCT04583969 | 1 November 2021→15 November 2021 | ACTIV-5 / Big Effect Trial (BET-B) for the Treatment of COVID-19 | A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults | | National Institute of Allergy and Infectious Diseases (NIAID) | 09/10/2020 | 20201009 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04583969 | Recruiting | No | N/A | N/A | All | October 19, 2020 | 400 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | United States;Korea, Republic of;United States | | 20-0013 Central Contact | | DMIDClinicalTrials@niaid.nih.gov | 13017617948 | |
<br> Inclusion Criteria:
<br>
<br> 1. Admitted to a hospital with symptoms suggestive of Coronavirus Disease 2019 (COVID-19)
<br> and requires ongoing medical care.
<br>
<br> 2. Subject (or legally authorized representative) provides informed consent prior to
<br> initiation of any study procedures.
<br>
<br> 3. Subject (or legally authorized representative) understands and agrees to comply with
<br> planned study procedures.
<br>
<br> 4. Male or non-pregnant female adult >/= 18 years of age at time of enrollment.
<br>
<br> 5. Illness of any duration and has laboratory-confirmed severe acute respiratory syndrome
<br> coronavirus 2 (SARS-CoV-2) infection as determined by polymerase chain reaction (PCR)
<br> or other commercial or public health assay (e.g., Nucleic Acid Amplification Test
<br> [NAAT], antigen test) in any respiratory specimen, or saliva </=14 days prior to
<br> randomization.
<br>
<br> 6. Illness of any duration, and requiring, just prior to randomization, supplemental
<br> oxygen (any flow), mechanical ventilation or Extracorporeal Membrane Oxygenation
<br> (ECMO) (ordinal score 5, 6, or 7).
<br>
<br> 7. Women of childbearing potential must agree to either abstinence or use at least one
<br> acceptable method of contraception* from the time of screening through 5 months post
<br> study intraperitoneal (IP) dosing.
<br>
<br> * Acceptable methods include barrier contraceptives (condoms or diaphragm) with
<br> spermicide, intrauterine devices (IUDs), hormonal contraceptives, oral contraceptive
<br> pills, and surgical sterilization.
<br>
<br> 8. Agrees not to participate in another blinded clinical trial (both pharmacologic and
<br> other types of interventions) for the treatment of COVID-19 through Day 29.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper
<br> limit of normal.
<br>
<br> 2. Subjects with a low glomerular filtration rate (eGFR), specifically:
<br>
<br> 1. Subjects with a glomerular filtration rate (eGFR) 20-30 mL/min are excluded
<br> unless in the opinion of the principal investigator (PI), the potential benefit
<br> of participation outweighs the potential risk of study participation.
<br>
<br> 2. All subjects with a glomerular filtration rate (eGFR) <20 mL/min (including
<br> hemodialysis and hemofiltration) are excluded.
<br>
<br> 3. Pregnancy or breast feeding.
<br>
<br> 4. Anticipated discharge from the hospital or transfer to another hospital which is not a
<br> study site within 72 hours of enrollment.
<br>
<br> 5. Allergy to any study medication.
<br>
<br> 6. Received five or more doses of remdesivir prior to screening.
<br>
<br> 7. Received small molecule tyrosine kinase inhibitors, including Janus kinase (JAK)
<br> inhibitors (e.g., baricitinib, ibrutinib, acalabrutinib, imatinib, gefitinib), in the
<br> 4 weeks prior to screening.
<br>
<br> 8. Received monoclonal antibodies targeting cytokines (e.g., tumor necrosis factor (TNF)
<br> inhibitors, anti-IL-1 [e.g., anakinra, canakinumab], anti-IL-6 [e.g., tocilizumab,
<br> sarilumab, sitlukimab]), or T-cells (e.g., abatacept) in the 4 weeks prior to
<br> screening.
<br>
<br> 9. Received monoclonal antibodies targeting B-cells (e.g., rituximab, and including any
<br> targeting multiple cell lines including B-cells) in the 3 months prior to screening.
<br>
<br> 10. Received granulocyte-macrophage colony-stimulating factor (GM-CSF) agents (e.g.,
<br> sargramostim) within 2 months prior to screening.
<br>
<br> 11. Received other immunosuppressants in the 4 weeks prior to screening and in the
<br> judgement of the investigator, the risk of immunosuppression with lenzilumab is larger
<br> than the risk of Coronavirus Disease 2019 (COVID-19).
<br>
<br> 12. Received any live vaccine in the 4 weeks prior to screening.
<br>
<br> 13. Known active tuberculosis.
<br>
<br> 14. Known history of Human Immunodeficiency Virus (HIV), Hepatitis B (HBV) or untreated
<br> hepatitis C (HCV) infection.
<br>
<br> 15. History of pulmonary alveolar proteinosis (PAP).
<br>
<br> 16. Has a malignancy currently receiving immunosuppressive chemotherapy, immunodeficiency,
<br> uncontrolled opportunistic infection, or uncontrolled cirrhosis.
<br>
<br> 17. Has a medical condition that could, in the judgment of the investigator, limit the
<br> interpretation and generalizability of trial results.
<br>
<br> 18. Positive test for influenza virus during the current illness (influenza testing is not
<br> required by protocol).
<br>
<br> 19. Previous participation in an ACTIV-5/Big Effect Trial (BET).
<br> | | COVID-19 | Biological: Lenzilumab;Other: Placebo;Drug: Remdesivir | Time to ventilation or death in subjects with a baseline score of 5 or 6 | | | | Yes | False | | |
| → | NCT04586413 | 12 December 2020→15 November 2021 | Post Acute COVID-19 Quality of Life (PAC-19QoL) Tool Development and Patient Registry (PAC-19QoLReg) | Post Acute COVID-19 Quality of Life (PAC-19QoL) Tool Development and Patient Registry (PAC-19QoLReg) | | Medialis Ltd. | 07/10/2020 | 20201007 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04586413 | Recruiting | No | 18 Years | N/A | All | October 7, 2020 | 100 | Observational | | | United Kingdom | ; ; | Ravi Jandhyala;Rose Watson;Ravi Jandhyala→Ravi Jandhyala;Omolade Femi-Ajao, PhD;Ravi Jandhyala | | ;rose@medialis.co.uk;ravi@medialis.co.uk→;research@medialis.co.uk;ravi@medialis.co.uk | ;44(0)7879994131;44(0)1744865→;+447502228066;44(0)1744865 | Medialis Ltd.; |
<br> Phase One
<br>
<br> Inclusion Criteria:
<br>
<br> - The participant has had either a confirmed COVID-19 test while infected or a confirmed
<br> COVID-19 antibody test post-infection
<br>
<br> - The participant is aged 18 years or older
<br>
<br> - The participant is capable of providing informed consent
<br>
<br> - The participant can read, write and converse in English
<br>
<br> - The participant can comply with the study schedule
<br>
<br> Exclusion Criteria:
<br>
<br> - The participant does not have a confirmed COVID-19 test or antibody test
<br>
<br> - The participant is aged under 18 years
<br>
<br> - The participant is not capable of giving informed consent
<br>
<br> - The participant is unable to read, write and converse in English
<br>
<br> - The participant is unable to comply with study schedule data collection
<br>
<br> Phase Two
<br>
<br> Inclusion Criteria:
<br>
<br> - The participant has had either a confirmed COVID-19 test while infected or a confirmed
<br> COVID-19 antibody test post-infection or a clinical diagnosis of COVID-19
<br>
<br> - The participant is aged 18 years or older
<br>
<br> - The participant is capable of providing informed consent
<br>
<br> - The participant can read, write and converse in English
<br>
<br> - The participant can comply with the study schedule
<br>
<br> Exclusion Criteria:
<br>
<br> - The participant does not have a confirmed COVID-19 test or antibody test or clinical
<br> diagnosis of COVID-19
<br>
<br> - The participant is aged under 18 years
<br>
<br> - The participant is not capable of giving informed consent
<br>
<br> - The participant is unable to read, write and converse in English
<br>
<br> - The participant is unable to comply with study schedule data collection
<br> | | Covid19 | Other: No intervention - quality of life measure | Design of PAC19QoL Measure (Phase One);Completion of PAC19QoL Measure monthly for 12 months (Phase Two) | | | | Yes | False | | |
| → | NCT04588363 | 5 July 2021→15 November 2021 | COVID-19: Pediatric Research Immune Network on SARS-CoV-2 and MIS-C | An Observational Cohort Study to Determine Late Outcomes and Immunological Responses After Infection With SARS-CoV-2 in Children With and Without Multisystem Inflammatory Syndrome (MIS-C) | PRISM | National Institute of Allergy and Infectious Diseases (NIAID) | 12/10/2020 | 20201012 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04588363 | Recruiting | No | N/A | 20 Years | All | November 19, 2020 | 250 | Observational | | | United States | ; ; → ; ; ; ; ; ; ; ; | Steven A. Webber, MBChB, MRCP;James D. Wilkinson, MD, MPH;Natasha B Halasa, MD, MPH→Steven A. Webber, MBChB, MRCP;James D. Wilkinson, MD, MPH;Natasha B Halasa, MD, MPH;Virginia Pascual, MD;Betty Diamond, MD;Ignacio Sanz, MD;Olivia Martinez, PhD;Sheri Krams, PhD;Jeremy Boss, PhD | | ;;→;;;;;;;; | ;;→;;;;;;;; | Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt;Vanderbilt Institute for Clinical and Translational Research (VICTR);Department of Pediatrics, Vanderbilt University Medical Center→Department of Pediatrics, Monroe Carell Jr. Children's Hospital at Vanderbilt;Vanderbilt Institute for Clinical and Translational Research (VICTR);Department of Pediatrics, Vanderbilt University Medical Center;Gale and Ira Drukier Institute for Children's Health, Weill Cornell Medicine;Institute of Molecular Medicine, The Feinstein Institute for Medical Research;Division of Rheumatology, Emory University;Stanford University;Stanford University;Emory University |
<br> Inclusion Criteria:
<br>
<br> 1. Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) detection from a
<br> respiratory specimen, and/or
<br>
<br> 2. Meets criteria for Multisystem Inflammatory Syndrome in Children (MIS-C), and/or
<br>
<br> 3. Meets criteria for MIS-C, except has involvement of only 1 organ system
<br>
<br> Cases meeting clinical criteria for MIS-C but without known SARS-CoV-2 exposure, and who
<br> are being treated as MIS-C by the treating physician, but with negative SARS-CoV-2 PCR and
<br> pending or negative antibody testing, may be enrolled as subjects. If subsequent antibody
<br> testing is positive, cases will be labelled as confirmed MIS-C. If SARS-CoV-2 antibody
<br> testing is negative, subjects will be labeled at the end of the study as suspected/not
<br> confirmed MIS-C.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subject and/or parent/guardian who are not able to understand or be willing to provide
<br> informed consent and where applicable assent
<br>
<br> --Note, for this observational cohort study, participation in other COVID-19 studies is not
<br> an automatic exclusionary criterion.
<br> | | Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2);Multisystem Inflammatory Syndrome in Children (MIS-C);Coronavirus Disease 2019 (COVID-19) | Other: SARS-CoV-2 and/or MIS-C Exposure | Proportion of Participants With Either COVID-19-Related Death, Rehospitalization, Major Complications after SARS-CoV-2 Illness and/or MIS-C at 6 Months Post Illness Presentation | | | | Yes | False | | |
| → | NCT04602507 | 11 January 2021→15 November 2021 | Ivermectin in Adults With Severe COVID-19. | Ivermectin in Adults With Severe COVID-19. Double-blind Randomized Clinical Trial | | CES University | 22/10/2020 | 20201022 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04602507 | Recruiting | No | 18 Years | 100 Years | All | December 7, 2020→December 10, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | Colombia | ; ; | Francisco L Ochoa-Jaramillo, MD; MSc;Federico Rodríguez-Vega, MD;;Federico Rodriguez-Vega, MD;Internist | | ;federicorodriguez@clinicaces.edu.co;federicodriguez@clinicaces.edu.co | ;57-3104261578;57-3104261578 | CES University; |
<br> Inclusion Criteria:
<br>
<br> - Over 18 years old.
<br>
<br> - Confirmed diagnosis of SARS-CoV-2 by polymerase chain reaction (PCR).
<br>
<br> - Diagnosis of severe pneumonia according to criteria of the National Institute of
<br> Health and the Colombian Consensus (suspected respiratory infection, organ failure,
<br> arterial oxygen saturation (SaO2) ambient air <90% or respiratory rate > 30 resp/min)
<br> or diagnosis of acute respiratory distress syndrome according to criteria of the
<br> National Institute of Health and the Colombian Consensus (clinical findings, bilateral
<br> radiographic infiltrates, + oxygenation deficit as well: mild: 200 mmHg < PaO2/FiO2
<br> (fraction of inspired oxygen) < 300 mm/Hg; moderate: 100 mm/Hg < PaO2/FiO2 < 200 mm/Hg
<br> and, severe: PaO2/FiO2 < 100 mm/Hg).
<br>
<br> - Less than 14 days since the onset of symptoms.
<br>
<br> - Hospitalized in a general internal medicine ward, special care unit, or those
<br> designated for managing patients with COVID19.
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnant or lactating women.
<br>
<br> - Use of ivermectin in the two weeks before admission to the clinic
<br>
<br> - Diseases affecting the blood-brain barrier (meningitis, encephalocranial trauma, acute
<br> subarachnoid hemorrhage)
<br>
<br> - Limitation to understanding the explanations and giving consent, defined by the
<br> investigating physician.
<br>
<br> - Patients with HIV/AIDS
<br>
<br> - That the patient is participating in another clinical trial.
<br> | | Covid19;Severe Acute Respiratory Syndrome | Drug: Ivermectin;Other: Placebo | Admission to the intensive care unit. | | | | Yes | False | | |
| → | NCT04611230 | 18 January 2021→15 November 2021 | A Study to Assess Infection Rate of Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2) and It's Affect on Quality of Life in Adult Volunteers in Lake County, Illinois | EpidemiologiCal POpulatioN STudy of SARS-CoV-2 in Lake CounTy, Illinois: CONTACT | CONTACT | AbbVie | 29/10/2020 | 20201029 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04611230 | Recruiting→Not recruiting | No | 18 Years | N/A | All | November 5, 2020 | 1250→1007 | Observational | | | United States | ; → | AbbVie Inc.;ABBVIE CALL CENTER→ABBVIE INC. | | ;abbvieclinicaltrials@abbvie.com→ | ;844-663-3742→ | AbbVie;→AbbVie |
<br> Inclusion Criteria:
<br>
<br> - Currently living or employed in Lake County, Illinois.
<br>
<br> - Have regular access to computer, smartphone or tablet and sufficient internet access
<br> to connect to study platform.
<br>
<br> - Willing and able to provide informed consent for collection of online data and of
<br> respiratory and blood specimens.
<br>
<br> - Willing and able to follow the procedures of the study.
<br>
<br> - Able to complete survey in English or Spanish.
<br>
<br> Exclusion Criteria:
<br>
<br> - Unable to provide informed consent.
<br>
<br> - Unable to perform the requested study tasks and unable or unwilling to assign a proxy
<br> informant to complete the tasks.
<br>
<br> - Hospitalized at the time of study enrollment.
<br> | | Severe Acute Respiratory Syndrome - CoronaVirus 2 (SARS-CoV-2) | | Percentage of Participants With Incidence of SARS-CoV-2 Infection;Percentage of Participants With Current SARS-CoV-2 Infection;Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection→Percentage of Participants With Evidence of Prior SARS-CoV-2 Infection;Percentage of Participants With Current SARS-CoV-2 Infection;Percentage of Participants With Incidence of SARS-CoV-2 Infection | | | | Yes | False | | |
| → | NCT04615429 | 16 February 2021→15 November 2021 | Clinical Trial to Assess the Efficacy of MSC in Patients With ARDS Due to COVID-19 | Double-blind, Randomized, Controlled, Clinical Trial to Assess the Efficacy of Allogenic Mesenchymal Stromal Cells in Patients With Acute Respiratory Distress Syndrome Due to COVID-19 | | Cristina Avendaño Solá | 25/10/2020 | 20201025 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04615429 | Not recruiting→Recruiting | No | 18 Years | N/A | All | September 15, 2020 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | Spain | ; ; ; → ; ; ; ; ; | Rafael F Duarte, MD, PhD;Cristina Avedano-Sola, MD, PhD;Juan J Rubio, MD, PhD;Rosa Malo, MD→Rafael F Duarte, MD, PhD;Cristina Avedano-Sola, MD, PhD;Juan J Rubio, MD, PhD;Rosa Malo, MD;Cristina Avendano-Sola, MD, PhD;Rafael F Duarte, MD, PhD | | ;;;→;;;;cavendano@salud.madrid.org;rduarte.work@gmail.com | ;;;→;;;;+34911916479;+34911916662 | Hematology Department. Hospital Universitario Puerta de Hierro;Clinical Pharmacology Department. Hospital Universitario Puerta de Hierro;ICU. Hospital Universitario Puerta de Hierro;Respiratory Medicine Department→Hematology Department. Hospital Universitario Puerta de Hierro;Clinical Pharmacology Department. Hospital Universitario Puerta de Hierro;ICU. Hospital Universitario Puerta de Hierro;Respiratory Medicine Department; |
<br> Inclusion Criteria:
<br>
<br> 1. Informed consent prior to performing study procedures (witnessed oral consent with
<br> written consent by representatives will be accepted to avoid paper handling). Written
<br> consent by patient or representatives will be obtained whenever possible.
<br>
<br> 2. Adult patients =18 years of age at the time of enrolment.
<br>
<br> 3. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in oropharyngeal swabs
<br> or any other relevant specimen obtained during the course of the disease. Alternative
<br> tests (e.g., rapid antigenic tests) are also acceptable as laboratory confirmation if
<br> their specificity has been accepted by the Sponsor.
<br>
<br> 4. Moderate to severe ARDS (PaO2/FiO2 ratio equal or less than 200 mmHg) for less than 96
<br> hours at the time of randomization.
<br>
<br> 5. Patients requiring invasive ventilation are eligible within 72 hours from intubation.
<br>
<br> 6. Eligible for ICU admission, according to the clinical team.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Imminent and unavoidable progression to death within 24 hours, irrespective of the
<br> provision of treatments (in the opinion of the clinical team).
<br>
<br> 2. "Do Not Attempt Resuscitation" order in place.
<br>
<br> 3. Any end-stage organ disease or condition, which in the investigator's opinion, makes
<br> the patient an unsuitable candidate for treatment.
<br>
<br> 4. History of a moderate/severe lung disorder requiring home-based oxygen therapy.
<br>
<br> 5. Patient requiring ECMO, hemodialysis or hemofiltration at the time of treatment
<br> administration.
<br>
<br> 6. Current diagnosis of pulmonary embolism.
<br>
<br> 7. Active neoplasm, except carcinoma in situ or basalioma.
<br>
<br> 8. Known allergy to the products involved in the allogenic MSC production process.
<br>
<br> 9. Current pregnancy or lactation (women with childbearing potential should have a
<br> negative pregnancy test result at the time of study enrollment).
<br>
<br> 10. Current participation in a clinical trial with an experimental treatment for COVID-19
<br> (the use of any off-label medicine according to local treatment protocols is not an
<br> exclusion criteria).
<br>
<br> 11. Any circumstances that in the investigator's opinion compromises the patient's ability
<br> to participate in the clinical trial.
<br> | | Acute Respiratory Distress Syndrome;COVID-19 Pneumonia | Biological: Mesenchymal stromal cells;Other: Placebo | Change in the PaO2/FiO2* ratio from baseline to day 7 of treatment administration | | | | Yes | False | | |
| → | NCT04616846 | 12 December 2020→15 November 2021 | Thromboembolic Risk Screening in Patients With Cancer and COVID-19 | Thromboembolic Risk Screening in Patients With Cancer and COVID-19 | NEOTHROCOVID | Centre Antoine Lacassagne | 02/11/2020 | 20201102 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04616846 | Recruiting | No | 18 Years | N/A | All | August 4, 2020 | 120 | Interventional | Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Screening. Masking: None (Open Label). | N/A | Monaco;France;Monaco;France→France;Monaco;France;Monaco | ; | Jérôme DOYEN, MD-PHD;Céline CELLIER-COËLLE | | ;celine.coelle@nice.unicancer.fr | ;0492031778 | Centre Antoine Lacassagne; |
<br> Inclusion Criteria:
<br>
<br> - COVID-19 testing ;
<br>
<br> - Age = 18 years old ;
<br>
<br> - Patient treated for histologically proven cancer (under treatment or last
<br> anti-neoplastic treatment < 3 months at the time of COVID-19 testing);
<br>
<br> - For the infected cohort: patient being screened for VTE at least one time 7 weeks
<br> after the COVID-19 diagnosistwo time point (day 1-10 after COVID-19 testing, and day
<br> 20-25 after COVID-19 testing) for retrospective cohort only;
<br>
<br> - Complete blood count available at time of COVID-19 testing (+/-14 days) to be able to
<br> calculate the Khorana score;
<br>
<br> - Patient informed and not opposed to the data processing;
<br>
<br> - Patient affiliated with a health insurance system.
<br>
<br> Exclusion Criteria:
<br>
<br> - Patient not able to give free consent;
<br>
<br> - Patient not able to understand the protocol;
<br>
<br> - For the infected patients: VTE screening not performed (for retrospective cohort
<br> only);
<br>
<br> - No available complete blood count at time of COVID-19 testing; Medical file and
<br> clinical follow-up not available during the study period (76 weeks after the COVID-19
<br> test);
<br>
<br> - Patients under 18 years;
<br>
<br> - Vulnerable persons as defined by article L1121-5-8:
<br>
<br> 1. Pregnant women, women in labour or breast-feeding mothers, persons deprived of
<br> their freedom by judicial or administrative decision, persons hospitalized
<br> without their consent by virtue of articles L. 3212-1 and L. 3213-1 and who are
<br> not subject to the provisions of article L. 1121-8
<br>
<br> 2. Persons admitted to a social or health facility for reasons other than research
<br>
<br> 3. Adults subject to a legal protection order or unable to give their consent
<br> | | Neoplasms Malignant;Covid19;Thromboembolism | Diagnostic Test: Peripheral venous ultrasound | Rate of venous thromboembolism | | | | Yes | False | | |
| → | NCT04625725 | 10 August 2021→15 November 2021 | Phase III Double-blind, Placebo-controlled Study of AZD7442 for Pre-exposure Prophylaxis of COVID-19 in Adult. | A Phase III Randomized, Double-blind, Placebo-controlled, Multi-center Study in Adults to Determine the Safety and Efficacy of AZD7442, a Combination Product of Two Monoclonal Antibodies (AZD8895 and AZD1061), for Pre-exposure Prophylaxis of COVID-19. | PROVENT | AstraZeneca | 10/11/2020 | 20201110 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04625725 | Not recruiting | No | 18 Years | 120 Years | All | November 21, 2020 | 5197 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | United States;United Kingdom;Spain;France;Belgium;United Kingdom;Spain;France;Belgium;United States | | Myron Levin, MD | | | | AstraZeneca |
<br> Inclusion Criteria:
<br>
<br> 1. = 18 years of age at the time of signing the informed consent
<br>
<br> 2. Can benefit from passive immunization with antibodies
<br>
<br> 3. Medically stable
<br>
<br> 4. Negative result from point of care SARS-CoV-2 serology testing at screening
<br>
<br> 5. Contraceptive used by women of child bearing potential, condom used by men
<br>
<br> 6. Able to understand and comply with study requirements/procedures based on the
<br> assessment of the investigator
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Significant infection or other acute illness, including fever >100°F (>37.8°C) on the
<br> day prior to or day of randomization.
<br>
<br> 2. History of laboratory-confirmed SARS-CoV-2 infection or any positive SARS-CoV-2 result
<br> based on available data at screening.
<br>
<br> 3. History of infection with severe acute respiratory syndrome (SARS) or Middle East
<br> respiratory syndrome (MERS).
<br>
<br> 4. Known history of allergy or reaction to any component of the study drug formulation.
<br>
<br> 5. Previous hypersensitivity, infusion-related reaction, or severe adverse reaction
<br> following administration of a mAb.
<br>
<br> 6. Any prior receipt of investigational or licensed vaccine or other mAb/biologic
<br> indicated for the prevention of SARS-CoV-2 or COVID-19 or expected receipt during the
<br> period of study follow-up.
<br>
<br> 7. Bleeding disorder or prior history of significant bleeding or bruising following IM
<br> injections or venepuncture.
<br>
<br> 8. Any other significant disease, disorder, or finding. that may significantly increase
<br> the risk to the participant because of participation in the study, affect the ability
<br> of the participant to participate in the study, or impair interpretation of the study
<br> data.
<br>
<br> 9. Receipt of any IMP in the preceding 90 days or expected receipt of IMP during the
<br> period of study follow-up, or concurrent participation in another interventional study
<br>
<br> 10. Currently pregnant or breastfeeding.
<br>
<br> 11. Blood drawn in excess of a total of 450 mL (1 unit) for any reason within 30 days
<br> prior to randomization.
<br>
<br> 12. Employees of the Sponsor involved in planning, executing, supervising, or reviewing
<br> the AZD7442 program,, clinical study site staff, or any other individuals involved
<br> with the conduct of the study, or immediate family members of such individuals.
<br>
<br> 13. In nations, states, or other jurisdictions that for legal or ethical reasons bar the
<br> enrollment of participants who lack capacity to provide their own informed consent,
<br> such subjects are excluded.
<br> | | COVID-19 | Drug: AZD7442;Drug: Placebo | AEs, SAEs, MAAEs, and AESIs post dose of IMP;The incidence of the first case of SARS CoV-2 RT PCR positive symptomatic illness | | | | Yes | False | | |
| → | NCT04628039 | 14 June 2021→15 November 2021 | Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs | Chronic Lung Disease and COVID-19: Understanding Severity, Recovery and Rehabilitation Needs (LAUREL Study) | LAUREL | VA Office of Research and Development | 09/11/2020 | 20201109 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04628039 | Recruiting | No | 18 Years | N/A | All | May 28, 2021 | 506→476 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Health Services Research. Masking: None (Open Label). | N/A | United States | ; ; | Kristina A Crothers, MD;Lisa A Batten, MD MHA MPH;Lisa A Batten, MD MHA MPH | | ;lisa.batten@va.gov;lisa.batten@va.gov | ;(206) 277-1780;206-277-1780 | VA Puget Sound Health Care System Seattle Division, Seattle, WA; |
<br> Inclusion Criteria:
<br>
<br> - (Patients) VA patients diagnosed with COVID-19
<br>
<br> - (Caregivers) Providing caregiving to VA patients diagnosed with COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> - Significant cognitive dysfunction
<br>
<br> - Language barriers
<br>
<br> - Severe psychiatric disorder impairing ability to participate in surveys and interviews
<br> →
<br> Inclusion Criteria:
<br>
<br> - (Patients) VA patients diagnosed with COVID-19 through a positive PCR (Polymerase
<br> Chain Reaction) or antigen SARS-CoV-2 test conducted in VA
<br>
<br> - (Caregivers) Providing caregiving to VA patients diagnosed with COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> - Significant cognitive dysfunction
<br>
<br> - Language barriers
<br>
<br> - Severe psychiatric disorder impairing ability to participate in surveys and interviews
<br> | | COVID-19 | Other: Rehabilitation-focused program | EuroQol 5 Dimension 5 Level (EQ-5D-5L) visual analog score;WHO Disability Assessment Schedule 2.0 (WHODAS 2.0);EuroQol 5 Dimension 5 Level (EQ-5D-5L) overall utility index→EuroQol 5 Dimension 5 Level (EQ-5D-5L) overall utility index;WHO Disability Assessment Schedule 2.0 (WHODAS 2.0);EuroQol 5 Dimension 5 Level (EQ-5D-5L) visual analog score | | | | Yes | False | | |
| → | NCT04633772 | 10 August 2021→15 November 2021 | Use of Angiotensin-(1-7) in COVID-19 | Randomized Clinical Trial Phase I/II for the Use of Angiotensin-(1-7) in the Treatment of Severe Infection by Sars-CoV-2 | | Erasme University Hospital | 06/11/2020 | 20201106 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04633772 | Recruiting→Not recruiting | No | 17 Years | 81 Years | All | August 5, 2020 | 130→112 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | Brazil | ; ; ; → ; ; | Robson AS Santos;Ana Martins Valle;Filippo Annoni;Robson AS Santos→Robson AS Santos;Ana Martins Valle;Filippo Annoni | | ;;;santos@icb.ufmg.br→;; | ;;;+55(31)987762956→;; | Angitex;Federal University of Minas Gerais;Hôpital Erasme;→Angitex;Federal University of Minas Gerais;Hôpital Erasme |
<br> Inclusion Criteria:
<br>
<br> - Admission to the Intensive Care Unit with severe pneumonia criteria (clinical signs of
<br> pneumonia + one of the following criteria: respiratory rate greater than 30/minute;
<br> signs of respiratory effort, SatO2 < 90% in room air);
<br>
<br> - COVID-19 confirmed or highly suspicious (positive contact or suggestive image)
<br>
<br> Exclusion Criteria:
<br>
<br> - Diagnosed with cancer (at any stage);
<br>
<br> - Hemodynamic instability (need for vasopressors);
<br>
<br> - Pregnant women; Immunocompromised patients;
<br>
<br> - Palliative Care;
<br>
<br> - Inclusion in any other interventionist study;
<br>
<br> - Heart failure as a predominant cause of acute respiratory failure;
<br>
<br> - Decompensated liver cirrhosis;
<br>
<br> - HIV +;
<br>
<br> - Dialysis;
<br>
<br> - Home / long-term oxygen therapy;
<br>
<br> - Idiopathic pulmonary fibrosis
<br> | | Infection, Coronavirus;Respiratory Failure | Drug: Angiotensin-(1-7);Drug: Placebo | supplemental oxygen-free days (SOFDs) | | | | Yes | False | | |
| → | NCT04634409 | 4 October 2021→15 November 2021 | A Study of Immune System Proteins in Participants With Mild to Moderate COVID-19 Illness | A Randomized, Double-blind, Placebo-Controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Mono and Combination Therapy With Monoclonal Antibodies in Participants With Mild to Moderate COVID-19 Illness (BLAZE-4) | BLAZE-4 | Eli Lilly and Company | 17/11/2020 | 20201117 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04634409 | Not recruiting | No | 18 Years | N/A | All | October 29, 2020 | 1782→1631 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | United States;Puerto Rico;Argentina;Puerto Rico;Argentina;United States→United States;Argentina;Puerto Rico;Argentina;Puerto Rico;United States | | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | | | | Eli Lilly and Company |
<br> Inclusion Criteria:
<br>
<br> - For low-risk participant arms 9-11 only: Are greater than or equal to (=)18 and less
<br> than (<)65 years of age at the time of randomization and do not have the risk factors
<br> defined in the bullet point directly below
<br>
<br> - For high-risk participant arms 12 and 13 only:
<br>
<br> -- Are =18 years of age and satisfy at least one of the following risk factors at the
<br> time of screening
<br>
<br> - Are =65 years of age
<br>
<br> - Have a body mass index (BMI) = 35
<br>
<br> - Have chronic kidney disease
<br>
<br> - Have type 1 or type 2 diabetes
<br>
<br> - Have immunosuppressive disease
<br>
<br> - Are currently receiving immunosuppressive treatment, or
<br>
<br> - Are =55 years of age AND have
<br>
<br> - cardiovascular disease, OR
<br>
<br> - hypertension, OR
<br>
<br> - chronic obstructive pulmonary disease or other chronic respiratory disease
<br>
<br> - For high-risk participant arms 12 and 13 only:
<br>
<br> - Are 12-17 years of age (inclusive) AND satisfy at least one of the following risk
<br> factors at the time of screening
<br>
<br> - Have a BMI =85th percentile for their age and gender based on CDC growth
<br> charts, https://www.cdc.gov/growthcharts/clinical_charts.htm
<br>
<br> - Have sickle cell disease
<br>
<br> - Have congenital or acquired heart disease
<br>
<br> - Have neurodevelopmental disorders, for example, cerebral palsy
<br>
<br> - Have a medical-related technological dependence, for example, tracheostomy,
<br> gastrostomy, or positive pressure ventilation (not related to COVID-19)
<br>
<br> - Have asthma or reactive airway or other chronic respiratory disease that
<br> requires daily medication for control
<br>
<br> - Have type 1 or type 2 diabetes
<br>
<br> - Have chronic kidney disease
<br>
<br> - Have immunosuppressive disease, or
<br>
<br> - Are currently receiving immunosuppressive treatment.
<br>
<br> For high-risk participants arm 14 only:
<br>
<br> - Are =12 years of age and satisfy at least one of the following risk factors at the
<br> time of screening Are =65 years of age
<br>
<br> - Are adults (=18 years of age) with BMI >25 kg/m2 , or if age 12-17, have BMI =85th
<br> percentile for their age and gender based on CDC growth charts
<br>
<br> - Have chronic kidney disease
<br>
<br> - Have type 1 or type 2 diabetes
<br>
<br> - Have immunosuppressive disease
<br>
<br> - Are currently receiving immunosuppressive treatment
<br>
<br> - Have cardiovascular disease (including congenital heart disease) or hypertension
<br>
<br> - Have chronic lung diseases (for example, chronic obstructive pulmonary disease, asthma
<br> [moderate-to-severe], interstitial lung disease, cystic fibrosis and pulmonary
<br> hypertension)
<br>
<br> - Have sickle cell disease
<br>
<br> - Have neurodevelopmental disorder (for example, cerebral palsy) or other conditions
<br> that confer medical complexity (for example, genetic or metabolic syndromes and severe
<br> congenital anomalies)
<br>
<br> - Have a medical-related technological dependence (for example, tracheostomy,
<br> gastrostomy, or positive pressure ventilation [not related to COVID-19]
<br>
<br> - Are currently not hospitalized
<br>
<br> - Have one or more mild or moderate COVID-19 symptoms: Fever, cough, sore throat,
<br> malaise, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with
<br> exertion, nasal congestion or runny nose, new loss of smell, chills
<br>
<br> - Must have sample taken for test confirming viral infection no more than 3 days prior
<br> to starting the drug infusion
<br>
<br> - Are men or non-pregnant women who agree to contraceptive requirements
<br>
<br> - Understand and agree to comply with planned study procedures
<br>
<br> - Agree to the collection of nasopharyngeal swabs and venous blood
<br>
<br> - The participant or legally authorized representative give signed informed consent
<br> and/or assent
<br>
<br> Exclusion Criteria:
<br>
<br> - For low-risk participants only: BMI =35
<br>
<br> - Have oxygen saturation (SpO2) less than or equal to (=)93 percent (%) on room air at
<br> sea level or ratio of arterial oxygen partial pressure (PaO2 in millimeters of
<br> mercury) to fractional inspired oxygen (FiO2) <300, respiratory rate =30 per minute,
<br> heart rate =125 per minute
<br>
<br> - Require mechanical ventilation or anticipated impending need for mechanical
<br> ventilation
<br>
<br> - Have known allergies to any of the components used in the formulation of the
<br> interventions
<br>
<br> - Have hemodynamic instability requiring use of pressors within 24 hours of
<br> randomization
<br>
<br> - Suspected or proven serious, active bacterial, fungal, viral, or other infection
<br> (besides COVID-19) that in the opinion of the investigator could constitute a risk
<br> when taking intervention
<br>
<br> - Have any co-morbidity requiring surgery within <7 days, or that is considered
<br> life-threatening within 29 days
<br>
<br> - Have any serious concomitant systemic disease, condition or disorder that, in the
<br> opinion of the investigator, should preclude participation in this study
<br>
<br> - Have a history of a positive SARS-CoV-2 test prior to the one serving as eligibility
<br> for this study
<br>
<br> - Have received an investigational intervention for SARS-CoV-2 prophylaxis within 30
<br> days before dosing
<br>
<br> - Have received treatment with a SARS-CoV-2 specific monoclonal antibody
<br>
<br> - Have a history of convalescent COVID-19 plasma treatment
<br>
<br> - For low-risk arms only: have received a SARS-CoV-2 vaccine or have participated in a
<br> previous SARS-CoV-2 vaccine study and are currently blinded to treatment allotment
<br>
<br> - Have participated, within the last 30 days, in a clinical study involving an
<br> investigational intervention. If the previous investigational intervention has a long
<br> half-life, 5 half-lives or 30 days, whichever is longer, should have passed
<br>
<br> - Are concurrently enrolled in any other type of medical research judged not to be
<br> scientifically or medically compatible with this study
<br>
<br> - Are pregnant or breast feeding
<br>
<br> - Are investigator site personnel directly affiliated with this study
<br>
<br> - Have body weight <40 kilograms
<br> | | COVID-19 | Drug: LY3819253;Drug: LY3832479;Drug: Placebo;Drug: VIR-7831;Drug: LY3853113 | Percentage of Participants with SARS-CoV-2 Viral Load Greater than 5.27 | | | | Yes | False | | |
| → | NCT04640194 | 1 November 2021→15 November 2021 | A Study to Test Whether Different Doses of Alteplase Help People With Severe Breathing Problems Because of COVID-19 | The TRISTARDS Trial - ThRombolysIS Therapy for ARDS A Phase IIb/III Operationally Seamless, Open-label, Randomised, Sequential, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Daily Intravenous Alteplase Treatment Given up to 5 Days on Top of Standard of Care (SOC) Compared With SOC Alone, in Patients With Acute Respiratory Distress Syndrome (ARDS) Triggered by COVID-19→The TRISTARDS Trial - ThRombolysIS Therapy for ARDS A Phase IIb/III Operationally Seamless, Open-label, Randomised, Sequential, Parallel-group Adaptive Study to Evaluate the Efficacy and Safety of Daily Intravenous Alteplase Treatment Given up to 5 Days on Top of Standard of Care (SOC) Compared With SOC Alone, in Patients With Acute Respiratory Distress Syndrome (ARDS) Triggered by COVID-19. | TRISTARDS | Boehringer Ingelheim | 20/11/2020 | 20201120 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04640194 | Recruiting | No | 18 Years | N/A | All | December 16, 2020 | 270→320 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2/Phase 3 | Austria;Belgium;Brazil;Denmark;France;Germany;Italy;Netherlands;Portugal;Russian Federation;Spain;Austria;Belgium;Brazil;Denmark;France;Germany;Italy;Netherlands;Portugal;Russian Federation;Spain→Spain;Russian Federation;Portugal;Netherlands;Italy;Germany;France;Denmark;Brazil;Belgium;Austria;Spain;Russian Federation;Portugal;Netherlands;Italy;Germany;France;Denmark;Brazil;Belgium;Austria | | Boehringer Ingelheim | | clintriage.rdg@boehringer-ingelheim.com | 1-800-243-0127 | |
<br> Inclusion Criteria:
<br>
<br> - Age = 18 years (or above legal age, e.g. UK =16 years)
<br>
<br> - ARDS with PaO2*/FiO2 ratio >100 and =300, either on non-invasive ventilator support,
<br> OR on mechanical ventilation (<48 hours since intubation),
<br>
<br> - with bilateral opacities in chest X-ray or CT scan (not fully explained by
<br> effusions, lobar/lung collapse, or nodules)
<br>
<br> - with respiratory failure (not fully explained by cardiac failure/fluid overload)
<br> (*or estimation of PaO2/FiO2 from pulse oximetry (SpO2/FiO2))
<br>
<br> - SARS-CoV-2 positive (laboratory-confirmed reverse transcription polymerase chain
<br> reaction (RT PCR) test)
<br>
<br> - Fibrinogen level = upper limit of normal (according to local laboratory)
<br>
<br> - D-Dimer = 3-fold of upper limit of normal (ULN) according to local laboratory
<br>
<br> - Signed and dated written informed consent in accordance with ICH Good Clinical
<br> Practice (GCP) and local legislation prior to admission to the Trial
<br>
<br> Exclusion Criteria:
<br>
<br> - Massive confirmed pulmonary embolism (PE) with haemodynamic instability at trial entry
<br>
<br> - Indication for therapeutic dosages of anticoagulants at trial entry
<br>
<br> - Patients on mechanical ventilation for longer than 48 hours
<br>
<br> - Chronic pulmonary disease i.e. with known forced expiratory volume in 1 second (FEV1)
<br> <50%, requiring home oxygen, or oral steroid therapy or hospitalisation for
<br> exacerbation within 12 months, or significant chronic pulmonary disease in the
<br> Investigator's opinion, or primary pulmonary arterial hypertension
<br>
<br> - Has a Do-Not-Intubate (DNI) or Do-Not-Resuscitate (DNR) order
<br>
<br> - In the opinion of the investigator not expected to survive for > 48 hours after
<br> admission
<br>
<br> - Planned interventions during the first 5 days after randomisation, such as surgery,
<br> insertion of central catheter or arterial line, drains, etc.
<br>
<br> - Patients with known hypersensitivity to the active substance alteplase, gentamicin (a
<br> trace residue from the manufacturing process) or to any of the excipients
<br>
<br> - Significant bleeding disorder at present or within the past 3 months, known
<br> haemorrhagic diathesis
<br>
<br> - Patients receiving effective oral anticoagulant treatment, e.g. vitamin K antagonists
<br> with International normalised ratio (INR) >1.3, or any direct oral anticoagulant
<br> within the past 48 hours Further exclusion criteria apply.
<br> | | Acute Respiratory Distress Syndrome | Drug: Alteplase;Procedure: Standard of care | Time to clinical improvement or hospital discharge | | | | Yes | False | | |
| → | NCT04642950 | 17 May 2021→15 November 2021 | A Phase II/III Study of Sargramostim | A Phase II/III Study of Sargramostim in Patients With Coronavirus Disease-2019 (COVID-19) | | Nobelpharma | 19/11/2020 | 20201119 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04642950 | Recruiting→Not recruiting | No | 20 Years | 85 Years | All | December 17, 2020 | 60→70 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | Japan | ␣→ | Masaki Taniguchi→ | | taniguchi.masaki@nobelpharma.co.jp→ | + 81-3-6670-3800→ | |
<br> Inclusion Criteria:
<br>
<br> Japanese male or female subjects who have been confirmed to meet all the following
<br> criteria.
<br>
<br> 1. Hospitalized patients under treatment who were severe acute respiratory syndrome
<br> coronavirus 2 [SARS-CoV-2] positive by polymerase chain reaction (PCR) test.
<br>
<br> 2. Patients with clinically diagnosed pneumonia and a percutaneous oxygen saturation
<br> [SpO2] of 93% or less on breathing of room air at bed rest.
<br>
<br> 3. Patients for whom written informed consent has been obtained from those themselves or
<br> the legally acceptable representatives.
<br>
<br> 4. Patients aged 20 years or older and younger than 85 years at the time of obtaining
<br> informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> Subjects who meet any of the following criteria will be excluded. Unless otherwise stated,
<br> the following criteria refer to those at the time of screening.
<br>
<br> 1. Patients who have been participating in other intervention studies, such as studies on
<br> unapproved pharmacotherapy, within 90 days prior to screening.
<br>
<br> 2. Patients who have experienced off-label use of approved drugs (including those for
<br> COVID-19 treatment other than steroids as standard treatment) within 7 days prior to
<br> screening.
<br>
<br> 3. Patients who are not expected to survive longer than 24 hours after commencement of
<br> study drug administration.
<br>
<br> 4. Patients who are using invasive ventilator or extracorporeal membrane oxygenation
<br> (ECMO).
<br>
<br> 5. Patients who have a chronic respiratory disease requiring continuous home oxygen
<br> therapy or ventilator use.
<br>
<br> 6. Patients with an underlying condition that is considered very unlikely to withdraw
<br> ventilator (e.g., motor neuron disease, Duchenne muscular dystrophy, rapidly
<br> progressive interstitial pulmonary fibrosis).
<br>
<br> 7. Patients who have a disease including bronchial asthma, lower respiratory tract
<br> infections, and interstitial lung diseases that may affect the assessment of the
<br> clinical study, since before the symptom onset of COVID-19.
<br>
<br> 8. Patients who have a disease including leukemia and leukocytosis that causes
<br> leukocytosis.
<br>
<br> 9. Patients who have a chronic kidney disease requiring dialysis.
<br>
<br> 10. Patients who have severe liver failure (Child Pugh grade C).
<br>
<br> 11. Patients aged 80 years or older with any of heart failure, cerebrovascular disease,
<br> obesity (BMI 30 or higher), dyslipidemia, hypertension or diabetes.
<br> | | COVID-19 | Drug: Sargramostim;Drug: Placebo | 2-rank improvement on a 7-point ordinal scale | | | | Yes | False | | |
| → | NCT04650087 | 4 October 2021→15 November 2021 | COVID-19 Thrombosis Prevention Trials: Post-hospital Thromboprophylaxis | COVID-19 Post-hospital Thrombosis Prevention Trial: An Adaptive, Multicenter, Prospective, Randomized Platform Trial Evaluating the Efficacy and Safety of Antithrombotic Strategies in Patients With COVID-19 Following Hospital Discharge | | Thomas L. Ortel | 30/11/2020 | 20201130 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04650087 | Recruiting | No | 18 Years | N/A | All | February 15, 2021 | 5320 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States | ; | Tracy Wang, MD;Tracy Wang, MD | | ;tracy.wang@duke.edu | ;919-668-8907 | Duke University; |
<br> Inclusion Criteria:
<br>
<br> - • Age = 18 years
<br>
<br> - PCR-positive COVID-19 infection
<br>
<br> - Hospitalized for two or more days
<br>
<br> Exclusion Criteria:
<br>
<br> - Pre-existing indication for anticoagulation (e.g., pulmonary embolism or deep vein
<br> thrombosis; atrial fibrillation; mechanical cardiac valve)
<br>
<br> - Contraindication to antithrombotic therapy (e.g., known bleeding within the last 30
<br> days requiring emergency room presentation or hospitalization; major surgery within 14
<br> days; ischemic stroke, intracranial bleed or neurosurgery within 3 months.
<br>
<br> - Platelet count < 50,000/mcL
<br>
<br> - Hemoglobin <8 gm/dL
<br>
<br> - Renal insufficiency (eGFR < 30 mL/min/1.73 m2)
<br>
<br> - Pregnancy
<br>
<br> - Prison inmate
<br>
<br> - Life expectancy less than 90 days
<br>
<br> - Unwilling or unable to provide informed consent/unwilling or unable to complete the
<br> study protocol
<br>
<br> - Dual antiplatelet therapy that cannot be discontinued
<br>
<br> - Concomitant need for strong inducers/inhibitors of p-gp or CYP3A4
<br> | | Covid19 | Drug: Apixaban 2.5 MG;Drug: Placebo | Composite outcome of symptomatic deep vein thrombosis, pulmonary embolism, other venous thromboembolism, ischemic stroke, myocardial infarction, other arterial thromboembolism, and all-cause mortality as measured by hospital records. | | | | Yes | False | | |
| → | NCT04651374 | 11 January 2021→15 November 2021 | COVID-19 And Geko Evaluation: The CAGE Study | COVID-19 And Geko Evaluation: The CAGE Study | CAGE | Lawson Health Research Institute | 27/11/2020 | 20201127 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04651374 | Not recruiting | No | 18 Years | N/A | All | December 2020→December 2021 | 40 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). →Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Canada | ; | Tina Mele;Tina Mele, MD PhD FRCSC | | ;Tina.Mele@lhsc.on.ca | ;519-663-3531 | Western University; |
<br> Inclusion Criteria:
<br>
<br> - Patients who test positive for Covid-19
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who are unlikely to be adherent or cannot tolerate the therapy (self-report)
<br>
<br> - Prior above or below knee amputation
<br>
<br> - A history of prior Deep Venous Thrombosis (DVT) or Venous Thromboembolism (VTE),
<br>
<br> - Those patients being treated with full dose therapeutic anticoagulation.
<br> →
<br> Inclusion Criteria:
<br>
<br> - Patients who test positive for Covid-19
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who are unlikely to be adherent or cannot tolerate the therapy (self-report)
<br>
<br> - Prior above or below knee amputation
<br>
<br> - A history of prior Deep Venous Thrombosis (DVT) or Venous Thromboembolism (VTE),
<br>
<br> - Those patients being treated with full dose therapeutic anticoagulation.
<br>
<br> - Patients with pacemakers
<br> | | Covid19 | Device: geko T3 | Mortality;Morbidity→Feasibility of recruitment;Safety of device: AE;Protocol Adherence | | | | Yes | False | | |
| → | NCT04655586 | 18 October 2021→15 November 2021 | Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 | Assessing Safety, Hospitalization and Efficacy of rNAPc2 in COVID-19 (ASPEN-COVID-19) | ASPEN | ARCA Biopharma, Inc. | 02/12/2020 | 20201202 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04655586 | Recruiting | No | 18 Years | 90 Years | All | December 10, 2020 | 160 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). | Phase 2/Phase 3 | United States;Brazil;Argentina;Brazil;Argentina;United States | ; | Marc Bonaca, MD, MPH;Jennifer Meriwether | | ;jennifer.meriwether@arcabio.com | ;720-940-2132 | CPC Clinical Research; |
<br> Inclusion Criteria:
<br>
<br> 1. Age = 18 years and = 90 years at the Screening assessment
<br>
<br> 2. Weight = 50 kg at randomization
<br>
<br> 3. Hospitalized with a diagnosis of COVID-19 and in need of inpatient medical care
<br>
<br> 4. Positive for SARS-CoV-2 on nasopharyngeal, oropharyngeal or other tissue/body fluid
<br> samples by PCR or validated other test of ongoing infection (not an antibody test for
<br> prior exposure), within seven (7) days of hospitalization or screening assessment
<br>
<br> 5. D-dimer level > upper limit of normal at screening
<br>
<br> 6. Provided electronic or written informed consent, either personally or through a
<br> legally authorized representative (LAR)
<br>
<br> 7. Must agree not to participate in a concurrent interventional study involving
<br> anticoagulation or anti-platelet therapy
<br>
<br> 8. Female patients of reproductive or child-bearing potential must be willing to use an
<br> effective method of contraception for the duration of the study, and male patients
<br> must be willing to use an effective method of contraception to avoid partner pregnancy
<br> and abstain from sperm donation for at least 90 days after last dose
<br>
<br> Exclusion Criteria:
<br>
<br> 1. High bleeding risk, e.g. major surgery within prior 1 month, history of a major bleed
<br> while receiving anticoagulation, recent hemorrhagic stroke, current or planned (during
<br> current hospitalization) dual anti-platelet therapy, platelet count <25,000/uL,
<br> current therapeutic anticoagulation for a medical indication other than COVID-19, e.g.
<br> atrial fibrillation, known thrombosis, hereditary or acquired coagulopathy treated
<br> with therapeutic anticoagulation. Patients receiving prophylactic anticoagulation are
<br> eligible if they are willing to discontinue current anticoagulation.
<br>
<br> 2. Sustained systolic blood pressure < 90 mmHg considered to be clinically significant
<br>
<br> 3. Persistent eGFR <20 ml/min/1.73m2
<br>
<br> 4. Known severe liver disease (e.g. bilirubin >3.5 mg/dL (60 umol/L))
<br>
<br> 5. Life expectancy estimated to be < 72 hours based on current clinical condition
<br>
<br> 6. Anticipated hospital discharge or transfer within 5 days based on current clinical
<br> condition
<br>
<br> 7. Known anti-phospholipid syndrome
<br>
<br> 8. Unable to receive heparin, e.g. history of heparin-induced thrombocytopenia and
<br> thrombosis (HITT)
<br>
<br> 9. Participation in any interventional clinical study with an investigational product
<br> within seven (7) days of the Screening assessment or within 5 half-lives of the
<br> investigational agent, whichever is longer
<br> | | Covid19 | Drug: rNAPc2;Drug: Heparin | Time to recovery within thirty (30) days of randomization using the ACTT ordinal scale (Phase 3);Number of major or non-major clinically relevant bleeding events within eight (8) days of randomization as compared to heparin (Phase 2b and 3);Change in D-dimer level from Baseline to Day 8, or day of discharge if prior to Day 8 (Phase 2b) | | | | Yes | False | | |
| → | NCT04665245 | 25 January 2021→15 November 2021 | Symptom-Based Markers for COVID-19 Transmission | Contact Network Transmission Modeling of Healthcare Associated Infections: Symptom-Based Markers for COVID-19 Transmission | | University of Iowa | 10/12/2020 | 20201210 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04665245 | Recruiting | No | 18 Years | 100 Years | All | December 15, 2020 | 500 | Observational | | | United States | | Alberto M Segre, PhD | | | | University of Iowa |
<br> Inclusion Criteria:
<br>
<br> - Fluent in English
<br>
<br> - Tested positive for COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> - Prisoners
<br>
<br> - Unable to provide own informed consent
<br> | | Covid19 | | COVID-19 Symptoms;Body Temperature | | | | Yes | False | | |
| → | NCT04667923 | 7 September 2021→15 November 2021 | Noninvasive Ventilation in Moderate-to-severe COVID-19-associated Acute Respiratory Distress-syndrome | Noninvasive Ventilation in Moderate-to-severe COVID-19-associated Acute Respiratory Distress-syndrome to Prevent Tracheal Intubation: the COVID-NIV Study | COVID-NIV | I.M. Sechenov First Moscow State Medical University | 11/12/2020 | 20201211 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04667923 | Recruiting→Not recruiting | No | 18 Years | 80 Years | All | October 1, 2020 | 50→80 | Observational | | | Russian Federation | ; ; → | Andrey I Yaroshetskiy, MD, PhD, ScD;Andrey I Yaroshetskiy, MD, PhD, ScD;Mikhail E Politov, MD, PhD→Andrey I Yaroshetskiy, MD, PhD, ScD | | ;dr.intensivist@gmail.com;mikhail.politiv@gmail.com→ | ;+79859900148;+79263711611→ | Sechenov University;→Sechenov University |
<br> Inclusion Criteria:
<br>
<br> - at least one of the following criteria: fatigue, Patrick scale 5 points, SpO2<92% on
<br> standard oxygen therapy (<15 l/min) or continuous positive airway pressure
<br> (CPAP)-therapy with oxygen flow<15 l/min
<br>
<br> Exclusion Criteria:
<br>
<br> - pregnancy
<br>
<br> - age less than 18 or more than 80 years
<br>
<br> - life-threatening heart rhythm abnormalities and/or systolic blood pressure < 80 mmHg
<br> despite norepinephrine at a dose > 2 µg/kg/min
<br>
<br> - primary lung diseases (e.g. interstitial lung diseases, lung emphysema) or tumour
<br> metastases in lungs
<br>
<br> - chronic decompensated diseases with extrapulmonary organ dysfunction (tumour
<br> progression, liver cirrhosis, congestive heart failure)
<br>
<br> - Glasgow cona score < 14
<br>
<br> - inability to swallow
<br>
<br> - upper airways obstruction
<br> | | Covid19;ARDS | Diagnostic Test: Respiratory monitoring;Diagnostic Test: Respiratory muscles ultrasound;Diagnostic Test: Electro impedance tomography;Diagnostic Test: Capnography;Diagnostic Test: Arterial blood gas;Diagnostic Test: Quasistatic pressure-volume curve | Mortality;Intubation rate | | | | Yes | False | | |
| → | NCT04672564 | 11 October 2021→15 November 2021 | Study to Evaluate Safety and Efficacy of Carrimycin for Treatment of Severe Coronavirus Disease 2019 (COVID-19) in Hospitalized Patients | A Phase 3, Randomized, Multicenter, Placebo-controlled, Double-blind Clinical Study of the Safety and Efficacy of Carrimycin for Treatment of Severe COVID-19 in Hospitalized Patients | | Shenyang Tonglian Group CO., Ltd | 16/12/2020 | 20201216 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04672564 | Recruiting | No | 18 Years | N/A | All | March 30, 2021 | 300 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | United States;Ukraine;Philippines;Peru;Mexico;India;Colombia;Brazil;Argentina;Ukraine;Philippines;Peru;Mexico;India;Colombia;Brazil;Argentina;United States→United States;Argentina;Brazil;Colombia;India;Mexico;Peru;Philippines;Ukraine;United States;Ukraine;Philippines;Peru;Mexico;India;Colombia;Brazil;Argentina | | Henry Wang | | Hwang0404@hotmail.com | 86 188 0403 2009 | |
<br> Inclusion Criteria:
<br>
<br> - Patient with SARS-CoV-2 infection as determined by real time polymerase chain reaction
<br> (RT- PCR) or other commercial or public health assay in any specimen taken = 4 days
<br> prior to randomization. Patient with a second SARS-CoV-2 episode after resolution of
<br> the initial infection may be enrolled if the infection is reconfirmed by RT-PCR and
<br> all other eligibility criteria are met. Patient hospitalized, who are requiring
<br> supplemental oxygen via nasal cannula, non-invasive ventilation or high-flow oxygen to
<br> maintain peripheral oxygen saturation of at least 92% at time of Screening
<br>
<br> - Female patient of childbearing potential and male patient with female partner of
<br> childbearing potential must agree to use at least one primary form of contraception
<br> for the duration of the study
<br>
<br> - Ability to provide informed consent personally, or by a legally acceptable
<br> representative if the patient is unable to do so
<br>
<br> - Patient is willing and able to comply with all required study visits and follow up
<br> required by the protocol
<br>
<br> - Patient must agree not to enroll in another study of an investigational agent prior to
<br> completion of Day 60 of study
<br>
<br> Exclusion Criteria:
<br>
<br> - Non-hospitalized patients, limitation of activities and/or requiring home oxygen
<br> support
<br>
<br> - Patient has a creatinine clearance < 50 mL/min using the modification of diet in renal
<br> disease formula
<br>
<br> - Patient has a known allergy to any study medication or macrolides
<br>
<br> - Patient with the presence of hepatitis B surface antigen at Screening
<br>
<br> - Patient has a positive hepatitis C antibody test result at Screening
<br>
<br> - Patient has a positive hepatitis C RNA test result at Screening
<br>
<br> - Patient was seropositive for human immunodeficiency virus
<br>
<br> - Patient has been treated with anti-tumor therapy with immunosuppressive effects, which
<br> includes chemotherapy, biologics and hormonal therapy in the past 30 days prior to
<br> Screening
<br>
<br> - Patient has used a macrolide in the week prior to Screening
<br>
<br> - Patient has used antiviral drugs which are not part of SOC < 24 hours prior to Day 1
<br>
<br> - Patient has used medications that are narrow therapeutic index cytochrome P450 (CYP)
<br> substrates or are strong inhibitors and/or inducers of CYP3A4 or CYP3A5 and organic
<br> anion transporting polypeptide (OATP)1B1 or OATP1B3 < 2 days prior to Day 1 and/or
<br> plans to initiate such medications during the treatment period
<br>
<br> - Patient has consumed foods and/or used herbal medicines with strong CYP3A4 or CYP3A5
<br> effects
<br>
<br> - Patient who, in the judgment of the Investigator, will be unlikely or unable to comply
<br> with the requirements of this protocol through Day 60
<br>
<br> - Female patient who is pregnant or breastfeeding
<br>
<br> - Critical patient with a life expectancy < 48 hours
<br>
<br> - Patient who has received an organ transplant in the past 6 months prior to Screening
<br> or is on the waiting list for organ transplantation
<br>
<br> - Patient with evidence of multiorgan failure (defined as two or more organs failing) or
<br> septic shock
<br>
<br> - Patient requiring mechanical ventilation or extracorporeal membrane oxygenation at
<br> Screening
<br>
<br> - Patient has a mean corrected QT interval using Fridericia's formula (QTcF) of > 450
<br> msec (for male patients) and > 470 msec (for female patients) at Screening
<br>
<br> - Patient who has a history of alcohol abuse within 3 months prior to the study as
<br> judged by the Investigator
<br> | | Coronavirus Disease 2019 | Drug: Carrimycin;Drug: Placebo | Percentage of patients alive without need for supplemental oxygen at Day 28 | | | | Yes | False | | |
| → | NCT04684615 | 1 November 2021→15 November 2021 | Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen | Mental Health Impact of the COVID-19 Pandemic on Amish and Mennonite Participants in AMBiGen | | National Institute of Mental Health (NIMH) | 23/12/2020 | 20201223 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04684615 | Recruiting | No | 18 Years | N/A | All | November 3, 2021→December 28, 2020 | 1000 | Observational | | | United States | | Francis J McMahon, M.D. | | | | National Institute of Mental Health (NIMH) |
<br> - INCLUSION CRITERIA:
<br>
<br> In order to be eligible to participate in this study, an individual must meet all of the
<br> following criteria:
<br>
<br> 1. Active enrollment in Protocol 80-M-0083
<br>
<br> 2. 18 years of age and older.
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> 1. Under age 18.
<br>
<br> INCLUSION OF VULNERABLE PARTICIPANTS:
<br>
<br> The study will be not be targeting any vulnerable populations. We are not planning to
<br> recruit children; all participants being invited to participate have previously been
<br> assessed under Protocol 80-M-0083 as over the age of 18.
<br> | | Depression;Anxiety;Bipolar Disorder | | To describe the relationship between stressors related to COVID-19 and self-rated measures of mental health symptoms and distress among a range of participants including various patient populations and healthy volunteers. | | | | Yes | False | | |
| → | NCT04689542 | 8 February 2021→15 November 2021 | Surgical Face Mask Effects in Patients With COVID-19 | Effects of Surgical Face Mask on Submaximal Exercise Test in Patients With COVID-19 | | Cliniques universitaires Saint-Luc- Université Catholique de Louvain | 29/12/2020 | 20201229 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04689542 | Recruiting→Not recruiting | No | 18 Years | 65 Years | All | January 1, 2021 | 30→28 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Double (Care Provider, Outcomes Assessor). | N/A | Belgium | ; → | William Poncin, PT, PhD;William Poncin→ | | william.poncin@uclouvain.be;→ | 027642818;→ | |
<br> Inclusion Criteria:
<br>
<br> - Hospitalized for COVID-19
<br>
<br> - No need of supplemental oxygen during the procedure (i.e. SpO2 of 96% or higher in
<br> ambient air)
<br>
<br> Exclusion Criteria:
<br>
<br> - Altered state of consciousness
<br>
<br> - Respiratory co-morbidities
<br>
<br> - Neurological or orthopedic co-morbidities susceptible to alter the reliability of the
<br> sit-to-stand test
<br>
<br> - Having required high flow nasal cannula or non-invasive ventilation during the
<br> hospital stay
<br> →
<br> Inclusion Criteria:
<br>
<br> - Hospitalized for COVID-19
<br>
<br> - No need of supplemental oxygen during the procedure
<br>
<br> Exclusion Criteria:
<br>
<br> - Altered state of consciousness
<br>
<br> - Respiratory co-morbidities
<br>
<br> - Neurological or orthopedic co-morbidities susceptible to alter the reliability of the
<br> sit-to-stand test
<br>
<br> - Having required high flow nasal cannula or non-invasive ventilation during the
<br> hospital stay
<br> | | Covid19 | Other: Sit-To-Stand test | Changes in dyspnea level | | | | Yes | False | | |
| → | NCT04695652 | 12 July 2021→15 November 2021 | A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult | A Phase II, Prospective, Double-blinded, Multi-Center, Multi-Regional Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS-CoV-2 Vaccine Candidate MVC-COV1901 | COVID-19 | Medigen Vaccine Biologics Corp. | 31/12/2020 | 20201231 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04695652 | Not recruiting | No | 20 Years | N/A | All | December 30, 2020 | 3700→3854 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 2 | Vietnam;Taiwan;Vietnam;Taiwan→Taiwan;Vietnam;Taiwan;Vietnam | ; | Szu-Min Hsieh, MD;Tzou-Yien Lin, MD | | ; | ; | National Taiwan University Hospital;Chang Gang Memorial Hospital, LinKou |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female participant = 20 to < 65 years, or = 65 years of age at randomization.
<br>
<br> 2. Healthy adults or adults with pre-existing medical conditions who are in stable
<br> condition. A stable medical condition is defined as disease not requiring significant
<br> change in therapy or hospitalization for worsening disease 3 months before enrollment
<br> and expected to remain stable for the duration of the study.
<br>
<br> 3. Female participant must:
<br>
<br> 1. Be either of non-childbearing potential, i.e. surgically sterilized (defined as
<br> having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral
<br> salpingectomy; tubal ligation alone is not considered sufficient) or one year
<br> post-menopausal;
<br>
<br> 2. Or, if of childbearing potential, be abstinent or agree to use medically
<br> effective contraception from 14 days before screening to 30 days following the
<br> last injection of study intervention. Acceptable forms include:
<br>
<br> i. Implanted hormonal methods of contraception or placement of an intrauterine device
<br> or intrauterine system ii. Established use of hormonal methods (injectable, pill,
<br> patch or ring) combined with barrier methods of contraception: condom or occlusive cap
<br> (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository c.
<br> Have a negative pregnancy test
<br>
<br> 4. Participant is willing and able to comply with all required study visits and follow-up
<br> required by this protocol.
<br>
<br> 5. Participant has not travelled overseas within 14 days of screening and will not have
<br> any oversea travelling throughout the study period.
<br>
<br> 6. Participant or the participant's legal representative must understand the procedures
<br> of the study and provide written informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnant or breast feeding or have plan to become pregnant in 30 days after last
<br> administration of study intervention.
<br>
<br> 2. Employees at the investigator's site, of the Sponsor or the contract research
<br> organization (CRO) directly involved in the conduct of the study.
<br>
<br> 3. Currently receiving or received any investigational intervention within 30 days prior
<br> to the first dose of study intervention.
<br>
<br> 4. Administered any licensed live-attenuated vaccines within 28 days or other licensed
<br> non-live-attenuated vaccines within 7 days prior to the first dose of study
<br> intervention.
<br>
<br> 5. Administered any blood product or intravenous immunoglobulin administration within 12
<br> weeks prior to the first dose of study intervention.
<br>
<br> 6. Currently receiving or anticipate to receive concomitant immunosuppressive or
<br> immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing
<br> corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone
<br> less than 20 mg or equivalent) within 12 weeks prior to the first dose of study
<br> intervention.
<br>
<br> 7. Currently receiving or anticipate to receive treatment with tumor necrosis factor
<br> (TNF)-a inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to
<br> the first dose of study intervention.
<br>
<br> 8. Major surgery or any radiation therapy within 12 weeks prior to the first dose of
<br> study intervention Medical Conditions
<br>
<br> 9. Immunosuppressive illness or immunodeficient state, including hematologic malignancy,
<br> history of solid organ, bone marrow transplantation, or asplenia.
<br>
<br> 10. A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma,
<br> polyarthritis, thyroiditis, Guillain-Barré syndrome, etc.).
<br>
<br> 11. A history of malignancy with potential risk for recurrence after curative treatment,
<br> or current diagnosis of or treatment for cancer (exceptions are squamous and basal
<br> cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the
<br> discretion of the investigator).
<br>
<br> 12. Bleeding disorder considered a contraindication to intramuscular injection or
<br> phlebotomy.
<br>
<br> 13. Human immunodeficiency virus (HIV) antibody positive participants with CD4 count < 350
<br> cells/mm3 or a detectable HIV viral load within the past year (low level variations
<br> from 50-500 viral copies/mL or equivalent which do not lead to changes in
<br> antiretroviral therapy [ART] are permitted).
<br>
<br> 14. Hepatitis B surface antigen (HBsAg) positive participant with positive hepatitis B e
<br> antigen (HBeAg) or abnormal liver function.
<br>
<br> 15. Hepatitis C virus (HCV) antibody positive participants with detectable HCV ribonucleic
<br> acid (RNA) viremia in recent 12 weeks.
<br>
<br> 16. Participant with ongoing acute diseases or serious medical conditions which will
<br> interfere with adherence to study requirements, or the evaluation of any study
<br> endpoint. Acute diseases or serious medical conditions include cardiovascular (e.g.
<br> New York Heart Association Grade III or IV), pulmonary (e.g. chronic obstructive
<br> pulmonary disease stage III or IV), hepatic (e.g. Child-Pugh Class C), neurologic
<br> (e.g. dementia), metabolic (e.g. diabetes mellitus with hemoglobin A1c [HbA1c] > 8%),
<br> renal (Stage 3 or worse chronic kidney disease), psychiatric condition (e.g.
<br> alcoholism, drug abuse), current severe infections, medical history, physical
<br> findings, or laboratory abnormality that in the investigators' opinion are not in
<br> stable condition and participating in the study could adversely affect the safety of
<br> the participant.
<br>
<br> Medigen Vaccine Biologics Corp. 34
<br>
<br> 17. Participant with previous known or potential exposure to SARS-CoV-1 or 2 viruses
<br> (EXCEPT for those who have been tested negative and completed the 14-day
<br> self-managements/ home quarantines/ home isolations) or received any other COVID-19
<br> vaccine.
<br>
<br> 18. Participant with a history of hypersensitivity to any vaccine or a history of allergic
<br> disease or reactions likely to be exacerbated by any component of the MVC-COV1901.
<br>
<br> 19. Body (oral, rectal, or ear) temperature = 38.0°C or acute illness (not including minor
<br> illnesses such as diarrhea or mild upper respiratory tract infection at the discretion
<br> of the investigator) within 2 days before the first dose of study intervention.
<br> | | Covid19 Vaccine | Biological: MVC-COV1901(S protein with adjuvant);Biological: MVC-COV1901(Saline) | Immunogenicity of MVC-COV1901;Incidence of Adverse Event within 28 days post the second study intervention (Safety of MVC-COV1901) | | | | Yes | False | | |
| → | NCT04700462 | 8 March 2021→15 November 2021 | COVID-19 Preventive Behavior in African Americans | Optimizing Tailored-feedback Message to Promote Adherence Behavior to Prevent COVID-19 in African Americans | | Johns Hopkins University | 06/01/2021 | 20210106 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04700462 | Recruiting→Not recruiting | No | 60 Years | N/A | All | February 5, 2021 | 250 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | N/A | United States | ; ; → | Chao Hsing Yeh, PhD;Chao Hsing Yeh, PhD;Chao H Yeh→Chao Hsing Yeh, PhD | | ;cyeh13@jhu.edu;cyeh13@jhu.edu→ | ;667-208-7637;410-502-0184→ | Johns Hopkins School of Nursing;→Johns Hopkins School of Nursing |
<br> Inclusion Criteria:
<br>
<br> - African American aged 60 or older
<br>
<br> - Able to read and write English
<br>
<br> - Willing to commit to use the smartphone app with the pop-up messages and then four
<br> follow-up surveys (total four months).
<br>
<br> Exclusion Criteria:
<br>
<br> - No children or others aged 59 years or younger
<br> | | Covid19;Health Behavior | Behavioral: Sm-EMA | Change in Global Impression of Change as assessed by a questionnaire;Change in preventive Behavior Score;Change in Self-efficacy as assessed by self-efficacy questionnaire;Change in Knowledge Test score as assessed by a questionnaire;Change in System Usability Scale (SUS) score→Change in Global Impression of Change as assessed by a questionnaire;Change in System Usability Scale (SUS) score;Change in preventive Behavior Score;Change in Self-efficacy as assessed by self-efficacy questionnaire;Change in Knowledge Test score as assessed by a questionnaire | | | | Yes | False | | |
| → | NCT04701515 | 18 January 2021→15 November 2021 | Cardiovascular Manifestations of COVID-19 | Cardiovascular Manifestations of COVID-19 | | Methodist Health System | 22/09/2020 | 20200922 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04701515 | Recruiting | No | 18 Years | N/A | All | June 10, 2020 | 500 | Observational | | | United States | ; ; | Manavjot Sidhu, MD;Crystee Cooper, DHEd;Manavjot Sidhu, MD | | ;ClinicalResearch@mhd.com; | ;214-947-1280; | Methodist Health System; |
<br> Inclusion Criteria:
<br>
<br> - Hospitalized patient
<br>
<br> - Adult over 18 years
<br>
<br> - Positive COVID-19 PCR Test
<br>
<br> Exclusion Criteria:
<br>
<br> - None
<br> | | COVID-19 | Other: Chart review | N-terminal prohormone BNP;Troponin I;Arrythmias;Pericarditis;Myocarditis;Pericardial Effusion;Tamponade;Heart failure→Heart failure;Tamponade;Pericardial Effusion;Myocarditis;Pericarditis;Arrythmias;Troponin I;N-terminal prohormone BNP | | | | Yes | False | | |
| → | NCT04706416 | 25 January 2021→15 November 2021 | N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19) | N-Acetyl Glucosamine as Therapeutic Intervention for Coronavirus Disease-19 (COVID-19) | | Quantinosis.ai LLC | 31/12/2020 | 20201231 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04706416 | Not recruiting | No | 18 Years | N/A | All | November 14, 2020 | 50→150 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). →Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | United States | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - =18 years old
<br>
<br> - Treated with NAG as first-line treatment
<br>
<br> - Present with COVID-19 symptoms (including but not limited to fever, cough, shortness
<br> of breath, sore throat, nasal congestion, malaise, headache, muscle pain, loss of
<br> taste and/or smell, diarrhea, and vomiting)
<br>
<br> - Clinically diagnosed with COVID-19 by RT-PCR
<br>
<br> - No intubation prior to hospitalization and enrollment in the current study.
<br>
<br> Exclusion Criteria:
<br>
<br> - <18 years old upon admission
<br>
<br> - Allergy to NAG
<br>
<br> - Allergy to shellfish
<br>
<br> - Currently taking warfarin
<br>
<br> - Currently pregnant or lactating
<br> →
<br> Inclusion Criteria:
<br>
<br> - =18 years old
<br>
<br> - Treated with N-acetyl glucosamine (NAG) as first-line treatment
<br>
<br> - Present with coronavirus disease 2019 (COVID-19) symptoms (including but not limited
<br> to fever, cough, shortness of breath, sore throat, nasal congestion, malaise,
<br> headache, muscle pain, loss of taste and/or smell, diarrhea, and vomiting)
<br>
<br> - Clinically diagnosed with COVID-19 by reverse transcription polymerase chain reaction
<br> (RT-PCR)
<br>
<br> - No intubation prior to hospitalization and enrollment in the current study.
<br>
<br> Exclusion Criteria:
<br>
<br> - <18 years old upon admission
<br>
<br> - Allergy to NAG
<br>
<br> - Allergy to shellfish
<br>
<br> - Currently taking warfarin
<br>
<br> - Currently pregnant or lactating
<br> | | Coronavirus;Covid19 | Dietary Supplement: N-acetyl glucosamine (NAG)→Dietary Supplement: N-acetyl glucosamine (NAG);Other: Control | Rate of intubation;Length of stay (LOS);Rate of mortality→Number of Participants Intubated During Hospitalization;Number of Participants Who Died During Hospitalization;Hospital Length of Stay (LOS) | →04/11/2021 | | →https://clinicaltrials.gov/ct2/show/results/NCT04706416 | Yes | False | | →Yes |
| → | NCT04707664 | 26 October 2021→15 November 2021 | Sargramostim Use in COVID-19 to Recover Patient Health | A Randomized Phase 2b Trial Evaluating Clinical Outcomes of Inhaled Sargramostim in High-risk Patients With Mild-moderate COVID-19 | SCOPE | Partner Therapeutics, Inc. | 11/01/2021 | 20210111 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04707664 | Recruiting | No | 18 Years | N/A | All | April 27, 2021 | 500 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | United States→United States;Argentina;United States | | Fiona Garner, PhD | | scopestudy@partnertx.com | (781) 819-4949 | |
<br> Inclusion Criteria:
<br>
<br> 1. Patients with a positive laboratory diagnosis of SARS-CoV-2 infection by an antigen or
<br> a molecular test =5 days prior to randomization. The test should have been authorized
<br> by the relevant regulatory authority.
<br>
<br> 2. Have one or more of the following mild or moderate COVID-19 symptoms for =5 days prior
<br> to randomization:
<br>
<br> 1. Fever or chills
<br>
<br> 2. New onset or worsening cough
<br>
<br> 3. Sore throat
<br>
<br> 4. Malaise or fatigue
<br>
<br> 5. Headache
<br>
<br> 6. Muscle pain (myalgias) or body aches
<br>
<br> 7. Gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea)
<br>
<br> 8. New onset or worsening shortness of breath or difficulty breathing
<br>
<br> 9. Nasal congestion or runny nose
<br>
<br> 10. New loss of taste (ageusia) and/or smell (anosmia). Note: any of these symptoms
<br> (ageusia, anosmia) alone or in combination cannot be used as the SOLE qualifying
<br> symptoms for enrollment.
<br>
<br> 3. At higher risk for progression to more severe COVID-19
<br>
<br> 1. Age = 60 years
<br>
<br> 2. Age 18-59 years with a clinically stable medical history of at least 1 or more of
<br> the following conditions that could lead to severe COVID-19:
<br>
<br> - Chronic respiratory conditions such as asthma, chronic obstructive pulmonary
<br> disease (COPD), pulmonary fibrosis
<br>
<br> - Obesity with BMI = 30 kg/m2
<br>
<br> - Cardiovascular disease
<br>
<br> - Sickle cell disease or thalassemia
<br>
<br> - Diabetes mellitus being managed with concomitant medications
<br>
<br> - Hypertension being managed with concomitant medications
<br>
<br> - Chronic kidney disease
<br>
<br> 4. Oxygen saturation by pulse oximeter > 93% on room air. Note: at altitudes of >4000
<br> feet above sea level, oxygen saturation by pulse oximeter > 91% on room air is
<br> permitted
<br>
<br> 5. Negative pregnancy test (if woman of childbearing potential)
<br>
<br> 6. Females of childbearing potential and males with female partners of childbearing
<br> potential must agree to use acceptable contraceptive methods from screening to Day 28
<br>
<br> 7. The patient (or legally authorized decision maker) must give informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Hospitalized patients
<br>
<br> 2. Patients who have received or are receiving other treatments that are not
<br> approved/authorized by the relevant regulatory authority for the treatment of patients
<br> with mild or moderate COVID-19 in an outpatient setting
<br>
<br> 3. Patients enrolled in interventional clinical trials for other experimental therapies
<br>
<br> 4. Patients on chronic oxygen supplementation due to cardiopulmonary or other conditions
<br>
<br> 5. Patients with unstable comorbid conditions (e.g., decompensated congestive heart
<br> failure, COPD with exacerbation, current angina pectoris, uncontrolled diabetes
<br> mellitus, uncontrolled hypertension, uncontrolled asthma)
<br>
<br> 6. Patients with severe pulmonary comorbid conditions, including systemic
<br> steroid-dependent asthma, systemic steroid-dependent COPD, oxygen-dependent COPD, lung
<br> transplant, or cystic fibrosis
<br>
<br> 7. Patients who have received highly immunosuppressive therapy (to include systemic
<br> corticosteroids) or anti-cancer combination chemotherapy within 24 hours prior to
<br> first dose of study drug
<br>
<br> 8. Patients with known or suspected intolerance or hypersensitivity to sargramostim, or
<br> any component of the product
<br>
<br> 9. Patients who have previously experienced severe and unexplained side effects during
<br> aerosol delivery of any kind of medical product
<br>
<br> 10. Pregnant or breastfeeding females
<br>
<br> 11. Patients who, in the opinion of the Investigator, will not be able to comply with all
<br> the study procedures and visits as outlined in the schedule of events, including
<br> follow-up
<br> | | Covid19;SARS-CoV Infection | Drug: Sargramostim;Drug: Placebo | Any emergency room visit or hospitalization, or death | | | | Yes | False | | |
| +++ | NCT04709835 | 15 November 2021 | Study to Evaluate the Effects of AT-527 in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19 | A Phase II Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Antiviral Activity, Safety, Pharmacokinetics, and Efficacy of RO7496998 (AT-527) in Non-Hospitalized Adult Patients With Mild or Moderate COVID-19 | | Hoffmann-La Roche | 12/01/2021 | 20210112 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04709835 | Not recruiting | Yes | 18 Years | N/A | All | February 3, 2021 | 104 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | Bulgaria;Canada;Greece;Ireland;Latvia;Lithuania;Poland;Spain;United Kingdom;Bulgaria;Canada;Greece;Ireland;Latvia;Lithuania;Poland;Spain;United Kingdom;United States | | Clinical Trials | | | | Hoffmann-La Roche |
<br> Inclusion Criteria:
<br>
<br> - Positive SARS-CoV-2 diagnostic test (RT-PCR or rapid antigen test)at screening
<br>
<br> - Has symptoms consistent with mild or moderate COVID-19, as determined by the
<br> investigator, with onset =5 days prior to randomization
<br>
<br> Exclusion Criteria:
<br>
<br> - Clinical signs indicative of COVID-19 illness requiring hospitalization, defined as
<br> any of the following: shortness of breath at rest, respiratory rate =30, heart rate
<br> =125, peripheral capillary oxygen saturation =93% on room air
<br>
<br> - Treatment with a therapeutic agent against SARS-CoV-2 including, but not limited to,
<br> other direct acting antivirals, convalescent plasma, monoclonal antibodies against
<br> SARS CoV-2, or intravenous immunoglobulin within 3 months or less than 5 drug
<br> elimination half-lives (whichever is longer) prior to screening
<br>
<br> - Requirement, in the opinion of the investigator, for any of the prohibited medications
<br> during the study
<br>
<br> - Use of hydroxychloroquine or amiodarone within 3 months of screening
<br>
<br> - Pregnant or breastfeeding, or intending to become pregnant during the study or within
<br> 30 days after the final dose of AT-527. Women of childbearing potential must have a
<br> negative urine pregnancy test result at screening
<br>
<br> - Abnormal laboratory test results at screening
<br>
<br> - Clinically significant abnormal ECG, as determined by the Investigator, at screening
<br>
<br> - Planned procedure or surgery during the study
<br>
<br> - Known allergy or hypersensitivity to study drug or drug product excipients
<br>
<br> - Substance abuse, as determined by the investigator, within 12 months prior to
<br> screening
<br>
<br> - Poor peripheral venous access
<br>
<br> - Malabsorption syndrome or other condition that would interfere with enteral absorption
<br>
<br> - Any clinically significant history of epistaxis within the last 3 months and/or
<br> history of being hospitalized due to epistaxis of any previous occasion
<br>
<br> - History of anaphylaxis
<br>
<br> - Any uncontrolled serious medical condition or other clinically significant abnormality
<br> in clinical laboratory tests that, in the investigator's judgment, precludes the
<br> patient's safe participation in and completion of the study
<br> | | COVID-19 | Drug: AT-527;Drug: Placebo | Change from Baseline in the Amount of Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Virus RNA | | | | Yes | True | parent | |
| → | NCT04723537 | 26 October 2021→15 November 2021 | Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease | Phase 2/3 Study of Upamostat, a Serine Protease Inhibitor, or Placebo for Treatment of COVID-19 Disease | | RedHill Biopharma Limited | 18/01/2021 | 20210118 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04723537 | Recruiting | No | 18 Years | N/A | All | February 16, 2021 | 310 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States;South Africa;United States | | Terry Plasse, MD | | | | RedHill Biopharma Limited |
<br> Inclusion Criteria:
<br>
<br> 1. Patients with symptomatic, diagnostically confirmed COVID-19, per RT-PCR or antigen
<br> assay of respiratory tract sample.
<br>
<br> 2. Patient must have either become symptomatic or found positive by RT-PCR or antigen
<br> assay within 5 days, whichever is greater, of randomization.
<br>
<br> 3. Patients must fill out a baseline questionnaire which is reviewed by study personnel
<br> to determine eligibility.
<br>
<br> 4. Males and females =age 18 years.
<br>
<br> 5. Oxygen saturation by pulse oximeter =92% on room air
<br>
<br> 6. Negative urine or serum pregnancy test (if woman of childbearing potential).
<br>
<br> 7. Females of childbearing potential and males with female partners of childbearing
<br> potential must agree to use acceptable contraceptive methods during the study and for
<br> at least two months after the last dose of study medication.
<br>
<br> 8. Ability to complete the daily diary independently.
<br>
<br> 9. The patient must give informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patient is in need of acute hospitalization per clinician assessment.
<br>
<br> 2. Pregnant or nursing women.
<br>
<br> 3. Unwillingness or inability to comply with procedures required in this protocol.
<br>
<br> 4. Patient requires supplemental oxygen.
<br>
<br> 5. Patient is currently receiving, has received within the past 7 days or is expected to
<br> receive during the course of the study remdesivir, or other specific antiviral or
<br> anticytokine therapy for COVID-19, other than therapeutic monoclonal antibodies
<br> allowed or approved in the region in which the patient lives, or systemic
<br> corticosteroid equivalent to =20 mg daily prednisone/3 mg dexamethasone daily.
<br>
<br> 6. Patient is currently receiving or has received within 30 days prior to screening any
<br> other investigational agent for any indication, including approved agents given for
<br> investigational indications (e.g., anti-cytokine treatments).
<br>
<br> 7. Patient is currently taking or is expected to start taking warfarin, apixaban
<br> (Eliquis), or rivaroxaban (Xarelto). Patients may be taking or start on study
<br> dabigatran (Pradaxa), standard or low molecular weight heparin.
<br> | | Covid19 | Drug: Part A: Upamostat 200 mg;Drug: Part A: Upamostat 400 mg;Drug: Part A and B: Placebo;Drug: Part B: Upamostat 200 or 400 mg | Part B - Comparison between upamostat and placebo in time to sustained recovery from symptomatic illness.;Part A - Determination of the safety and tolerability of two dose levels and selection of an upamostat dose for part B | | | | Yes | False | | |
| → | NCT04732949 | 18 October 2021→15 November 2021 | Study to Assess Efficacy and Safety of Inhaled Interferon-ß Therapy for COVID-19 | A Randomised, Double-blind, Placebo-controlled, Phase III Trial to Determine the Efficacy and Safety of Inhaled SNG001 for the Treatment of Patients Hospitalised Due to Moderate COVID-19 | SPRINTER | Synairgen Research Ltd. | 28/01/2021 | 20210128 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04732949 | Recruiting | Yes | 18 Years | N/A | All | January 12, 2021 | 610 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 3 | Israel;Italy;Mexico;Netherlands;Portugal;Romania;Serbia;Spain;United Kingdom;United States;India;Germany;France;Colombia;Brazil;Belgium;Argentina;United Kingdom;Spain;Serbia;Romania;Portugal;Netherlands;Mexico;Italy;Israel;India;Germany;France;Colombia;Brazil;Belgium;Argentina;United States→Israel;India;Germany;France;Colombia;Brazil;Belgium;Argentina;United Kingdom;Spain;Serbia;Romania;Portugal;Netherlands;Mexico;Italy;Israel;India;Germany;France;Colombia;Brazil;Belgium;Argentina;United States;Italy;Mexico;Netherlands;Portugal;Romania;Serbia;Spain;United Kingdom;United States | ; | Professor Tom Wilkinson;Jody Brookes | | ;Jody.Brookes@synairgen.com | ;44 (0) 23 8051 2800 | University Hospital Southampton NHS Foundation Trust; |
<br> Inclusion Criteria:
<br>
<br> - Admitted to hospital due to the severity of their COVID-19
<br>
<br> - Positive virus test for SARS-CoV-2 using a validated molecular assay or antigen assay.
<br> Patients who had a positive virus test for SARS-CoV-2 prior to hospitalisation will be
<br> randomised no later than 48 hours after hospital admission. If the virus test is
<br> performed more than 96 hours prior to hospitalisation, the test will have to be
<br> repeated in the hospital prior to randomisation. Only patients whose repeated virus
<br> test is positive will be randomised, no later than 48 hours after confirmation of
<br> SARS-CoV-2 infection. Patients who had their first positive virus test for SARS-CoV-2
<br> after hospitalisation will be randomised no later than 48 hours after confirmation of
<br> SARS-CoV-2 infection
<br>
<br> - Require oxygen therapy via nasal prongs or mask (WHO OSCI score of 4)
<br>
<br> - Provided informed consent
<br>
<br> - Female patients must be =1 year post-menopausal, surgically sterile, or using a
<br> protocol defined highly effective method of contraception
<br>
<br> - Women of child bearing potential should have been stable on their chosen method of
<br> birth control for a minimum of 3 months before entering the trial and should continue
<br> with birth control for 1 month after the last dose of inhaled interferon-ß
<br> (IFN-ß1a)/matching placebo. In addition to the highly effective method of
<br> contraception (except for the practice of total sexual abstinence), a condom (in
<br> United Kingdom with spermicides) should be used by the male partner for sexual
<br> intercourse from randomisation (Visit 2) and for 1 month after the last dose of
<br> inhaled IFN-ß1a/matching placebo to prevent pregnancy
<br>
<br> - Women not of childbearing potential are defined as women who are either permanently
<br> sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who
<br> are postmenopausal. Women will be considered post-menopausal if they have been
<br> amenorrhoeic for 12 months prior to the planned date of randomisation without an
<br> alternative medical cause. The following age specific requirements apply: women <50
<br> years old will be considered post-menopausal if they have been amenorrhoeic for 12
<br> months or more following cessation of exogenous hormonal treatment and if follicle
<br> stimulating hormone (FSH) levels are in the postmenopausal range; women =50 years old
<br> will be considered post-menopausal if they have been amenorrhoeic for 12 months or
<br> more following cessation of all exogenous hormonal treatment. If, in the setting of
<br> the pandemic, the use of an acceptable birth control method is not possible, the
<br> decision to enrol a woman of childbearing potential should be based on the
<br> benefit-risk for the patient, which should be discussed with the patient at the time
<br> of the informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Evidence of ongoing SARS-CoV-2 infection for more than 3 weeks, confirmed by a
<br> validated molecular assay or validated antigen assay
<br>
<br> - Non-invasive ventilation continuous positive airway pressure/bilevel positive airway
<br> pressure (CPAP/BiPAP) or high-flow nasal oxygen therapy (WHO OSCI score of 5)
<br>
<br> - Endotracheal intubation and invasive mechanical ventilation (WHO OSCI score of =6) or
<br> admission to intensive care
<br>
<br> - Previous SARS-CoV-2 infection confirmed by a validated molecular assay or validated
<br> antigen assay
<br>
<br> - Any condition, including findings in the patients' medical history or in the
<br> pre-randomisation study assessments that in the opinion of the Investigator,
<br> constitute a risk or a contraindication for the participation of the patient into the
<br> study or that could interfere with the study objectives, conduct or evaluation
<br>
<br> - Participation in previous clinical trials of SNG001
<br>
<br> - Current or previous participation in another clinical trial where the patient has
<br> received a dose of an Investigational Medicinal Product containing small molecules
<br> within 30 days or 5 half-lives (whichever is longer) prior to entry into this study or
<br> containing biologicals within 3 months prior to entry into this study
<br>
<br> - Inability to use a nebuliser with a mouthpiece
<br>
<br> - Inability to comply with the requirements for storage conditions of study medication
<br> in the home setting
<br>
<br> - History of hypersensitivity to natural or recombinant IFN-ß or to any of the
<br> excipients in the drug preparation
<br>
<br> - Females who are breast-feeding, lactating, pregnant or intending to become pregnant.
<br> | | Severe Acute Respiratory Syndrome Coronavirus 2;COVID-19 | Drug: SNG001;Drug: Placebo | Time to recovery;Time to hospital discharge | | | | Yes | True | parent →child | |
| → | NCT04733105 | 22 March 2021→15 November 2021 | Pronostic Value of Type I ANTi-Interferon Antibodies in Patients With COVID-19 Acute Respiratory Failure | Pronostic Value of Type I ANTi-Interferon Antibodies in Patients With COVID-19 Acute Respiratory Failure: a Multicenter Observational Study | ANTICOV | Assistance Publique - Hôpitaux de Paris | 24/01/2021 | 20210124 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04733105 | Recruiting→Not recruiting | No | 18 Years | N/A | All | November 19, 2020→November 20, 2020 | 530→1022 | Observational | | | France | ; ; → | Nicolas De PROST, MD, PhD;Nicolas De Prost, MD, PhD;Nicolas De Prost, MD, PhD→Nicolas De PROST, MD, PhD | | ;nicolas.de-prost@aphp.fr;nicolas.de-prost@aphp.fr→ | ;+33 1 49 81 23 94;+33 1 49 81 23 94→ | APHP;→APHP |
<br> Inclusion Criteria:
<br>
<br> - Age = 18 years
<br>
<br> - SARS-CoV-2 infection with a positive PCR
<br>
<br> - Patient admitted in the ICU for acute respiratory failure (SpO2=90% and need for
<br> supplemental oxygen or any kind of ventilator support)
<br>
<br> - Patient or next of keen was informed of study inclusion
<br>
<br> Exclusion Criteria:
<br>
<br> • Patient with SARS-CoV-infection but no acute respiratory failure
<br> | | Acute Respiratory Failure | | day-28 mortality | | | | No | False | | |
| → | NCT04733677 | 10 August 2021→15 November 2021 | User Experience of the OSR M-1 | User Experience of the OSR M1 Reusable Elastomeric Air Purifying Respirator in Non-Clinical Settings | | Wake Forest University Health Sciences | 27/01/2021 | 20210127 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04733677 | Recruiting | No | N/A | N/A | All | March 19, 2021 | 200 | Observational | | | United States | ; ; | Philip J Brown, PhD;Philip J Brown, PhD;Philip J Brown, PhD | | ;phibrown@wakehealth.edu;phibrown@wakehealth.edu | ;336-716-0945;336-716-0945 | Wake Forest University Health Sciences; |
<br> Inclusion Criteria:
<br>
<br> - Clinical staff who are issued and routinely wear N95 FFR or equivalent APR's are
<br> eligible.
<br>
<br> Exclusion Criteria:
<br>
<br> - Participants unable to pass the fit testing will be excluded from the study.
<br>
<br> - Anyone with a contraindication to wearing an N95 FFR (I.e. pregnancy, underlying
<br> medical conditions) will be excluded from the study.
<br> | | Covid19 | | User Acceptance Percentage;Percentage of Participants that fit in a Large Size Mask;Percentage of Participants that fit in a Medium Size Mask;Percentage of Participants that Fit in a Small Size Mask;Quality of Fit Score;Percentage of Successful Fits→Percentage of Successful Fits;Quality of Fit Score;Percentage of Participants that Fit in a Small Size Mask;Percentage of Participants that fit in a Medium Size Mask;Percentage of Participants that fit in a Large Size Mask;User Acceptance Percentage | | | | Yes | False | | |
| → | NCT04748172 | 12 April 2021→15 November 2021 | COVID-19 Vaccine and Ovarian Reserve | The Effect of COVID -19 mRNA Vaccine on Ovarian Reserve | | Sheba Medical Center | 06/02/2021 | 20210206 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04748172 | Recruiting→Not recruiting | No | 18 Years | 42 Years | Female | February 1, 2021 | 200 | Observational | | | Israel | ␣→ | Dr. A Mohr-Sasson, M.D→ | | mohraya@gmail.com→ | 97235302777→ | |
<br> Inclusion Criteria:
<br>
<br> - Age 18-42
<br>
<br> - No previous exposure to covid-19 vaccine (first or second dose)
<br>
<br> - No known past Covid-19 infection
<br>
<br> Exclusion Criteria:
<br>
<br> - Premature ovarian failure
<br>
<br> - Endometriosis
<br>
<br> - Polycystic ovary syndrome
<br>
<br> - Pregnancy
<br>
<br> - Fertility treatment
<br> →
<br> Inclusion Criteria:
<br>
<br> - Age 18-42
<br>
<br> - No previous exposure to Covid-19 vaccine (first or second dose)
<br>
<br> - No known past Covid-19 infection
<br>
<br> Exclusion Criteria:
<br>
<br> - Premature ovarian failure
<br>
<br> - Pregnancy
<br>
<br> - Fertility treatment
<br>
<br> - Past Covid-19 infection
<br> | | Fertility Issues;Vaccine Adverse Reaction | Biological: SARS-CoV-2 virus vaccines;Diagnostic Test: AMH sampling→Biological: SARS-CoV-2 virus vaccines;Diagnostic Test: AMH sampling;Diagnostic Test: anti Covid-19 antibody levels (Serology) | Delta in AMH levels | | | | Yes | False | | |
| → | NCT04748445 | 24 August 2021→15 November 2021 | Acute Respiratory Illness Surveillance (AcRIS) With Mobile Application in a Low-Interventional Decentralized Study. | Acute Respiratory Illness Surveillance (ARIS) by Monitoring Voice and Illness Symptom Changes Using a Mobile Application in a Low-Interventional Decentralized Study.→Acute Respiratory Illness Surveillance (AcRIS) by Monitoring Voice and Illness Symptom Changes Using a Mobile Application in a Low-Interventional Decentralized Study. | | Pfizer | 05/02/2021 | 20210205 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04748445 | Not recruiting | No | 18 Years | N/A | All | April 12, 2021 | 6250 | Observational | | | United States | | Pfizer CT.gov Call Center | | | | Pfizer |
<br> Inclusion Criteria:
<br>
<br> Participants are eligible to be included in the study only if all of the following criteria
<br> apply:
<br>
<br> Age and Sex:
<br>
<br> 1. Male or female participants =18 years of age (or the minimum state specific age of
<br> consent if >18), at Screening visit.
<br>
<br> Type of Participant and Disease Characteristics:
<br>
<br> 2. Participants who are willing and able to comply with daily symptom and voice
<br> assessments on the electronic diary application and other study procedures, including
<br> self-collection of nasal swabs.
<br>
<br> 3. Expected to be available for the duration of the study.
<br>
<br> Informed Consent:
<br>
<br> 4. Capable of giving signed informed consent
<br>
<br> -
<br>
<br> Exclusion Criteria:
<br>
<br> Participants are excluded from the study if any of the following criteria apply:
<br>
<br> Medical Conditions:
<br>
<br> 1. Participants who self-report any medical condition, recreational substance use, or
<br> medication use which would prevent them from completing study tasks or impair the
<br> providing of informed consent, or in the investigator's judgment, make the participant
<br> inappropriate for the study.
<br>
<br> 2. Prior/Concomitant Therapy: Participants who have been vaccinated with COVID-19 vaccine
<br> or are planning to get vaccinated during the 8 weeks of the study. Participants can
<br> continue to use all other prescription or non-prescription medications.
<br>
<br> Prior/Concurrent Clinical Study Experience:
<br>
<br> 3. Previous administration with an investigational drug within 30 days of enrollment (or
<br> as determined by the local requirement) or planning to participate in an
<br> interventional trial during study conduct.
<br>
<br> Diagnostic Assessments:
<br>
<br> 4. Screening diagnostic assessments are not required for eligibility purposes.
<br>
<br> Other Exclusions:
<br>
<br> 5. Investigator site staff or Pfizer employees directly involved in the conduct of the
<br> study, site staff otherwise supervised by the investigator including vendors, and
<br> their respective family members.
<br>
<br> 6. Participants who use a mobile device that does not meet the minimum requirements of
<br> the Electronic diary.
<br>
<br> -
<br> →
<br> Inclusion Criteria:
<br>
<br> Participants are eligible to be included in the study only if all of the following criteria
<br> apply:
<br>
<br> Age and Sex:
<br>
<br> 1. Male or female participants =18 years of age (or the minimum state specific age of
<br> consent if >18), at Screening visit.
<br>
<br> Type of Participant and Disease Characteristics:
<br>
<br> 2. Participants who are willing and able to comply with daily symptom and voice
<br> assessments on the electronic diary application and other study procedures, including
<br> self-collection of nasal swabs.
<br>
<br> 3. Expected to be available for the duration of the study.
<br>
<br> Informed Consent:
<br>
<br> 4. Capable of giving signed informed consent
<br>
<br> -
<br>
<br> Exclusion Criteria:
<br>
<br> Participants are excluded from the study if any of the following criteria apply:
<br>
<br> 1. Participants who self-report any medical condition, recreational substance use, or
<br> medication use which would prevent them from completing study tasks or impair the
<br> providing of informed consent, or in the investigator's judgment, make the participant
<br> inappropriate for the study.
<br>
<br> Prior/Concomitant Therapy:
<br>
<br> 2. Participants who have been vaccinated with COVID-19 vaccine or are planning to get
<br> vaccinated during study participation.
<br>
<br> Participants can continue to use all other prescription or non-prescription
<br> medications.
<br>
<br> Prior/Concurrent Clinical Study Experience:
<br>
<br> 3. Previous vaccination with any licensed or investigational RSV vaccine or are planning
<br> to get vaccinated during study participation.
<br>
<br> 4. Previous administration with an investigational drug within 30 days of enrollment (or
<br> as determined by the local requirement) or planning to participate in an
<br> interventional trial during study conduct.
<br>
<br> Diagnostic Assessments:
<br>
<br> 5. Screening diagnostic assessments are not required for eligibility purposes.
<br>
<br> Other Exclusions:
<br>
<br> 6. Investigator site staff or Pfizer employees directly involved in the conduct of the
<br> study, site staff otherwise supervised by the investigator including vendors, and
<br> their respective family members.
<br>
<br> 7. Participants who use a mobile device that does not meet the minimum requirements of
<br> the Electronic diary.
<br>
<br> 8. Participants who have previously been enrolled in the study cannot be re-enrolled.
<br> | | Healthy | Diagnostic Test: SARS-CoV-2/Influenza/RSV RT-PCR | Change in voice features; such as pitch, jitter, harmonicity, entropy, flatness, shimmer from the voice collection as captured by the Electronic diary from well to sick in symptomatic SARS-CoV-2 positive participants.;Change in self-reported symptom scores (Likert scale from 0-7) in the Electronic diary from well to sick in symptomatic SARS-CoV-2 positive participants.→Change in self-reported symptom scores (Likert scale from 0-7) in the Electronic diary from well to sick in symptomatic SARS-CoV-2, influenza virus or RSV positive participants.;Change in self-reported symptom scores (Likert scale from 0-7) in the Electronic diary from well to sick in symptomatic SARS-CoV-2, influenza virus or RSV positive participants. | | | | Yes | False | | |
| → | NCT04749173 | 1 November 2021→15 November 2021 | To Assess the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Which is the Treatment of COVID-19 in Healthy Volunteers. | A Double-blind, Randomized, Placebo-controlled, Single-ascending Dose Phase I Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of Niclosamide Injectable (DWRX2003) Following Intramuscular Administration in Healthy Volunteers | | Daewoong Pharmaceutical Co. LTD. | 20/01/2021 | 20210120 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04749173 | Recruiting→Not recruiting | No | 19 Years | 55 Years | All | November 21, 2020 | 24 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 1 | Korea, Republic of | ␣→ | Jang Hee Hong, Md, PhD→ | | boniii@cnu.ac.kr→ | 042-280-6910→ | |
<br> Inclusion Criteria:
<br>
<br> 1. Healthy adults aged 19 or older and 55 or younger at the time of screening test
<br>
<br> 2. A person who weighs 55.0 kg or more and whose BMI (body mass index) is above 18.0 and
<br> below 29.9;
<br>
<br> 3. A person who has listened to the detailed explanation of this clinical trial and fully
<br> understood, decided to participate voluntarily, and agreed in writing before the
<br> screening procedure.
<br>
<br> 4. A person who is eligible for this test when determining the person in charge of the
<br> test (or co-researcher who has been commissioned) due to physical examination,
<br> clinical laboratory examination, or examination.
<br>
<br> 5. A person who has been tested negative for Corona-19 virus (COVID-19) infection
<br> conducted during a screening visit.
<br>
<br> 6. A person who has agreed to use medically acceptable contraception during the
<br> pre-clinical trial period;
<br>
<br> Exclusion Criteria:
<br>
<br> 1. A person with a history or medical condition that includes one or more of the
<br> following diseases:
<br>
<br> 1. A person who is hypersensitive or has an history of overreaction to a clinical
<br> trial medication (or a component of a clinical trial medication) or emergency
<br> medication (epinephrine, dexamethasone, etc.)
<br>
<br> 2. hepatitis B (active hepatitis B or carrier), hepatitis C, human immunodeficiency
<br> virus (HIV), or syphilis infection (unless fully cured in case of hepatitis B
<br> virus history)
<br>
<br> 3. A person who is deemed clinically significant in determining the test manager (or
<br> a joint researcher) for the past or present history of asthma, rash, vascular
<br> edema, eczema, etc.
<br>
<br> 4. A person who has clinical significance, liver, kidney, nervous system,
<br> respiratory system, endocrine system, blood, tumor, cardiovascular, urinary
<br> system, mental system disease, or history
<br>
<br> 5. A person who has a history of malignant tumors in the past or present
<br>
<br> 6. A person who has a history of whole-body anti-infection that has been terminated
<br> within 28 days prior to the administration of clinical trial medication, or a
<br> history of systemic or local infection that requires hospitalization or
<br> intravenous administration within 6 months before clinical trial medication is
<br> administered.
<br>
<br> 7. A person who has undergone surgical intervention or surgery within 28 days prior
<br> to the administration of a clinical trial medication or is scheduled to undergo
<br> surgical procedures during the clinical trial period.
<br>
<br> 8. A person who has a clinically significant blood clotting disorder or tendency to
<br> hemorrhagic
<br>
<br> 2. A person who shows the following results in a screening test:
<br>
<br> ? A person whose blood level of AST (SGOT) and ALT (SGPT) exceeds twice the upper
<br> limit of the reference range ? A person whose blood treatment line level exceeds the
<br> upper limit of the reference range or whose eGFR calculated by the Modification of
<br> Diet in Rental Disase (MDR) formula is less than 90ml/min/1.73? ? A person who has
<br> been found to be abnormal in the 12-lead ECG test ? In the vital signs measured at the
<br> left position after a rest for more than three minutes, a person who showed a figure
<br> equivalent to systolic blood pressure of "90 mmHg or > 150 mmHg or extended blood
<br> pressure of "60 mmHg or >100 mmHg." ? A person who has tested positive for serum (RPR
<br> Ab, anti-HIV (AIDS), HBs Ag, HCV Ab) ? A person whose C-reactive protein (CRP) level
<br> is 1.5 times higher than the upper limit of the reference range.
<br>
<br> ? In addition, a person who showed the results of a decision that the test manager (or
<br> a commissioned joint researcher) is clinically significant;
<br>
<br> 3. A person who has a history of drug abuse or has tested positive for abuse in urine
<br> drug testing
<br>
<br> 4. A person who participated in other clinical trials (including biological equivalence
<br> tests) within six months prior to the administration of the clinical trial medication
<br> (one test subject cannot participate in another cohort)
<br>
<br> 5. A person who has given full blood or blood donation within two months or within one
<br> month before the administration of a clinical trial medication or received blood
<br> transfusion within one month before the administration of a clinical trial medication.
<br>
<br> 6. A person who drinks continuously (21 units/week, 1 unit = 10 g of pure alcohol) within
<br> three months prior to administration of clinical trial medication, or cannot drink
<br> alcohol during hospitalization.
<br>
<br> 7. A person who smokes more than 10 cigarettes a day within one month prior to the
<br> administration of a clinical trial medication or who is not allowed to smoke during
<br> the hospitalization period.
<br>
<br> 8. A person who is not prohibited from eating anything other than food provided by the
<br> clinical testing institution during his/her admission period;
<br>
<br> 9. A male person who has a child plan or plans to donate sperm during the period prior to
<br> the clinical trial, or a female person who has a plan to conceive or breast-feed.
<br>
<br> 10. In addition to the above criteria, a person deemed inappropriate for the participation
<br> of a clinical trial by the person in charge of testing (or a joint researcher who has
<br> been delegated)
<br> | | Covid19 | Drug: DWRX2003→Drug: DWRX2003, 288mg;Drug: DWRX2003, 432mg;Drug: DWRX2003, 672mg;Drug: DWRX2003, 960mg | Incidence of Treatment-Emergent Adverse Events | | | | No | False | | |
| → | NCT04760639 | 26 October 2021→15 November 2021 | COVID Breath Test - Ancon | Breath Test Feasibility Trial for COVID-19 Infection Diagnosis | | Medical University of South Carolina | 10/02/2021 | 20210210 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04760639 | Recruiting→Not recruiting | No | 18 Years | N/A | All | December 16, 2020 | 100 | Observational | | | United States | ; → | Michael F Balassone;Michael F Balassone→ | | Balassom@musc.edu;Balassom@musc.edu→ | 843-6792-6696;843-792-6696→ | |
<br> Inclusion Criteria:
<br>
<br> - Age 18 years and older
<br>
<br> - Patients that present for COVID-19 testing, have tested Covid negative, or Covid
<br> Positive patients.
<br>
<br> Exclusion Criteria:
<br>
<br> - Unable to consent
<br>
<br> - Patients on a ventilator
<br>
<br> - Pregnant Women
<br> | | Covid19 | Diagnostic Test: Breath test | Provide an adequate sample and compare the signals given from the two groups. | | | | No | False | | |
| → | NCT04764773 | 1 March 2021→15 November 2021 | Persistence of Symptoms After Improvement of Acute COVID-19 | Persistence of Symptoms After Improvement of Acute COVID19 Infection in Sohag Governorate, Egypt, A Longitudinal Study | COVID-19 | Sohag University | 19/02/2021 | 20210219 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04764773 | Recruiting→Not recruiting | No | N/A | N/A | All | May 1, 2020 | 250→172 | Observational | | | Egypt | ; ; → | Noha Abdelrahman, assistant-lecturer;Mona Abdelrahmam, Lecturer;Mona Abdelrahman, lecturer→Noha Abdelrahman, assistant-lecturer | | ;monamohamed@med.sohag.edu.eg;monamohamed@med.sohag.edu.eg→ | ;01021025895;01021025895→ | Sohag University;→Sohag University |
<br> Inclusion Criteria:
<br>
<br> Positive for SARS-CoV2
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients with severe complex illness, pregnant or lactating females and patient who
<br> refuse to participate or give complete detailed history
<br> | | Corona Virus Infection | Other: No intervention | Risk factors for persistent symptoms after recovery of acute covid19;Type of persistent symptom after acute covid19;Percentage of patient who had persistent symptoms after recovery of acute covid19 | | | | No | False | | |
| → | NCT04771624 | 8 March 2021→15 November 2021 | Assessment of Executive Functions After Covid-19 | May Covid-19 Impair Executive Functions?→May Covid-19 Impair Executive Functions? A Crossectional Study | | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | 22/02/2021 | 20210222 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04771624 | Recruiting→Not recruiting | No | 18 Years | N/A | All | October 30, 2020 | 100→128 | Observational | | | Turkey | ; ; → | Mehmet D Güleken, MD;Mehmet D Güleken, MD;Mehmet D Güleken, MD→Mehmet D Güleken, MD | | ;mdguleken@hotmail.com;mdguleken@hotmail.com→ | ;+905063282603;+905063282603→ | Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital;→Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital |
<br> Inclusion Criteria:
<br>
<br> Covid-19 patients:
<br>
<br> - Diagnosed as Covid-19 by RT-PCR at least 60 days but not more than 90 days ago
<br>
<br> - Asymptomatic at the moment
<br>
<br> - Not having any other general medical, neurological or psychiatric conditions except
<br> Covid-19 at the time of acute infection
<br>
<br> Healthy subjects:
<br>
<br> - Not having any of Covid-19 symptoms at the testing time point
<br>
<br> - Not having any general medical, neurological or psychiatric condition
<br>
<br> Exclusion Criteria:
<br>
<br> Covid-19 patients:
<br>
<br> - Diagnosed as Covid-19 by RT-PCR less than 60 days or more than 90 days ago
<br>
<br> - Having any symptom of acute phase of Covid-19
<br>
<br> - Having any other general medical, neurlogical or psychiatric contidions
<br>
<br> Healthy subjects:
<br>
<br> - Having any of Covid-19 symptoms at the testing time point
<br>
<br> - Having any general medical, neurological or psychiatric condition
<br> | | Covid19;Cognitive Impairment | | Neuropsychological test scores | | | | No | False | | |
| → | NCT04786808 | 16 March 2021→15 November 2021 | Risk Factors for COVID-19 Mortality | Risk Factors for COVID-19 Mortality: a Prospective Observational Study | RF-COVID | Teodoro Marcianò | 05/03/2021 | 20210305 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04786808 | Recruiting→Not recruiting | No | 18 Years | N/A | All | January 15, 2021 | 200 | Observational | | | Italy | ; → | Teodoro Marcianò;Teodoro Marcianò→ | | t.marciano@ausl.pc.it;t.marciano@ausl.pc.it→ | +390523303287;+390523303287→ | |
<br> Inclusion Criteria:
<br>
<br> - Admission to the Emergency Medicine Ward from the Emergency Department of Piacenza
<br> Hospital (Italy)
<br>
<br> - Confirmed COVID-19 diagnosis through molecular test obtained from nasal-pharyngeal
<br> swabs in the Emergency Department
<br>
<br> - Age above 18
<br>
<br> Exclusion Criteria:
<br>
<br> - inability to obtain an informed consent due to neurological conditions.
<br>
<br> - patient's refusal to sign the informed consent
<br>
<br> - inability of researchers to recruit the patient in the first 24 hours from the
<br> admission.
<br> | | COVID-19 Virus Infection;Population at Risk;Acute Respiratory Distress Syndrome | | Mortality rate | | | | Yes | False | | |
| → | NCT04791462 | 22 March 2021→15 November 2021 | COVID-19 in Osteoarthritis Patients | Observational Descriptive Study of Stress Symptoms Related to the COVID-19 Outbreak in a Cohort of Osteoarthritis Patients | | University Hospital, Montpellier | 26/02/2021 | 20210226 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04791462 | Not recruiting→Recruiting | No | 18 Years | 100 Years | All | March 10, 2021 | 500 | Observational | | | France | ; ; | Yves-Marie PERS, M.D., Ph. D.;Yves-Marie PERS, M.D., Ph. D.;Yves-Marie PERS | | ;ym-pers@chu-montpellier.fr; | ;6 18 99 38 04; | UH Montpellier; |
<br> Inclusion criteria:
<br>
<br> - OA patients
<br>
<br> Exclusion criteria:
<br>
<br> - active or passive opposition of the patient and / or its legal representatives to
<br> participate in the study.
<br> | | Osteoarthritis | | Assessing the state of post-traumatic stress | | | | Yes | False | | |
| → | NCT04796896 | 26 October 2021→15 November 2021 | A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age | A Phase 2/3, Two-Part, Open-Label, Dose-Escalation, Age De-escalation and Randomized, Observer-Blind, Placebo-Controlled Expansion Study to Evaluate the Safety, Tolerability, Reactogenicity, and Effectiveness of mRNA-1273 SARS-CoV-2 Vaccine in Healthy Children 6 Months to Less Than 12 Years of Age | | ModernaTX, Inc. | 11/03/2021 | 20210311 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04796896 | Recruiting | No | 6 Months | 11 Years | All | March 15, 2021 | 13275 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States→United States;Canada;United States | | Moderna Clinical Trials | | clinicaltrials@modernatx.com | 877-913-3286 | |
<br> Key Inclusion Criteria:
<br>
<br> - For participants with chronic diseases (such as, asthma, diabetes mellitus, cystic
<br> fibrosis, human immunodeficiency virus [HIV] infection), the disease should be stable,
<br> per investigator assessment.
<br>
<br> - Investigator assessment that the parent(s)/legally acceptable representatives
<br> understand and are willing and physically able to comply with protocol mandated follow
<br> up, including all procedures, written informed consent is provided, and participants
<br> provide assent.
<br>
<br> - For children 2 years of age or older has a body mass index at or above the third
<br> percentile according to World Health Organization (WHO) Child Growth Standards at the
<br> Screening Visit.
<br>
<br> - For children 6 months to <12 months of age: born at full-term with a minimum birth
<br> weight of 2.5 kilograms (kg).
<br>
<br> - For female participants of childbearing potential: negative pregnancy test, adequate
<br> contraception or has abstained from all activities that could result in pregnancy for
<br> at least 28 days prior to the first injection, agreement to continue adequate
<br> contraception or abstinence through 3 months following the second injection, and not
<br> currently breastfeeding.
<br>
<br> Key Exclusion Criteria:
<br>
<br> - Known history of SARS-CoV-2 infection within 2 weeks prior to administration of
<br> vaccine or known close contact with anyone with laboratory-confirmed SARS-CoV-2
<br> infection or COVID-19 within 2 weeks prior to administration of vaccine.
<br>
<br> - Prior administration of an investigational or approved CoV (such as, SARS-CoV-2, SARS
<br> CoV, Middle East Respiratory Syndrome CoV) vaccine.
<br>
<br> - Treatment with investigational or approved agents for prophylaxis against COVID 19
<br> (such as, receipt of SARS-CoV-2 monoclonal antibodies) within 6 months prior to
<br> enrollment.
<br>
<br> - Known hypersensitivity to a component of the vaccine or its excipients.
<br>
<br> - A medical or psychiatric condition that, according to the investigator's judgment, may
<br> pose additional risk as a result of participation, interfere with safety assessments,
<br> or interfere with interpretation of results.
<br>
<br> - History of a diagnosis or condition that, in the judgment of the investigator, may
<br> affect study endpoint assessment or compromise participant safety.
<br>
<br> - Received any non-study vaccine within 14 days before or after any dose of vaccine
<br> (except for seasonal influenza vaccine, which is not permitted within 14 days before
<br> or after any dose of vaccine)
<br>
<br> - Received intravenous or subcutaneous blood products (red blood cells, platelets,
<br> immunoglobulins) within 3 months prior to Day 1
<br>
<br> - Participated in an interventional clinical study within 28 days prior to Day 0 or
<br> plans to donate blood products while participating in this study.
<br> | | SARS-CoV-2 | Biological: mRNA-1273;Biological: Placebo | Seroresponse Rate of Vaccine Recipients;Geometric Mean (GM) of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Specific Serum Antibody;Number of Participants with Serum Antibody Levels that Meet or Exceed the Threshold of Protection From COVID-19;Number of Participants with Adverse Events of Special Interest (AESIs), Including Multisystem Inflammatory Syndrome in Children (MIS-C), Myocarditis and/or Pericarditis;Number of Participants with Serious Adverse Events (SAEs);Number of Participants with Medically-Attended AEs (MAAEs);Number of Participants with Unsolicited Adverse Events (AEs);Number of Participants with Solicited Local and Systemic Adverse Reactions (ARs) | | | | Yes | False | | |
| → | NCT04802408 | 20 September 2021→15 November 2021 | SARS-Cov-2 (COVID-19) Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial | SARS-Cov-2 (COVID-19) Nasal Pharyngeal and Oral Pharyngeal Wash (SNOW) Trial | SNOW | Milton S. Hershey Medical Center | 10/03/2021 | 20210310 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04802408 | Not recruiting→Recruiting | No | 18 Years | N/A→65 Years | All | September 30, 2021→October 1, 2021 | 200 | Interventional | Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | Phase 2/Phase 3 | →United States | ; | Rena Kass, MD;Rena Kass, MD | | ;rkass@pennstatehealth.psu.edu | ;717-531-8815 | Penn State College of Medicine; |
<br> Inclusion Criteria:
<br>
<br> 1. Students at Penn State University, University Park campus
<br>
<br> 2. A first-time positive test for SARS-CoV-2 infection within 5 days of enrollment
<br>
<br> 3. 18 years of age or older
<br>
<br> 4. Currently in isolation
<br>
<br> 5. Symptomatic or asymptomatic from SARS-CoV-2
<br>
<br> Exclusion Criteria:
<br>
<br> 1. History of nasal or sinus surgery
<br>
<br> 2. Non-English speaking
<br>
<br> 3. Lack of electronic device (computer, mobile phone etc.) on which to access an app for
<br> study data collection.
<br>
<br> 4. Students that need inpatient care for COVID-19 or any of its complications.
<br>
<br> 5. Students that give a history of being unable to tolerate gargles or nasal washes.
<br>
<br> 6. Students who do not give informed consent for study participation.
<br>
<br> 7. A history of a Covid-19 vaccination
<br>
<br> 8. A history of a positive antibody test
<br>
<br> 9. A history of use of nasal or oral washes after SARS-CoV-2 test sample collection.
<br>
<br> 10. Prisoners
<br>
<br> 11. Students that give history of current pregnancy (NO KNOWN CONTRAINDICATION TO
<br> PREGNANCY)
<br> →
<br> Inclusion Criteria:
<br>
<br> 1. A first-time positive test for SARS-CoV-2 infection within 5 days of enrollment
<br>
<br> 2. Adults who are =18 -65 years of age
<br>
<br> 3. Currently in isolation
<br>
<br> 4. Symptomatic or asymptomatic from SARS-CoV-2
<br>
<br> Exclusion Criteria:
<br>
<br> 1. History of nasal or sinus surgery
<br>
<br> 2. Non-English speaking
<br>
<br> 3. Lack of electronic device (computer, mobile phone etc.) on which to access an app for
<br> study data collection.
<br>
<br> 4. Adults that need inpatient care for COVID-19 or any of its complications.
<br>
<br> 5. Adults that give a history of being unable to tolerate gargles or nasal washes.
<br>
<br> 6. Adults who do not give informed consent for study participation.
<br>
<br> 7. History of a Covid vaccine booster
<br>
<br> 8. A history of use of nasal or oral washes after SARS-CoV-2 test sample collection.
<br>
<br> 9. Prisoners
<br>
<br> 10. Adults that give history of current pregnancy (NO KNOWN CONTRAINDICATION TO PREGNANCY)
<br>
<br> 11. History of monoclonal antibody treatment
<br>
<br> 12. History of or current molnupiravir treatment
<br> | | Covid19;SARS-CoV Infection | Combination Product: Shampoo and saline;Combination Product: Saline and Listerine;Combination Product: Shampoo and Listerine;Combination Product: Saline and Saline | Viral Load Change from baseline | | | | Yes | False | | |
| → | NCT04805671 | 1 November 2021→15 November 2021 | Evaluation of ADG20 for the Treatment of Mild or Moderate COVID-19 | A Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of ADG20 in the Treatment of Ambulatory Participants With Mild or Moderate COVID-19 (STAMP) | STAMP | Adagio Therapeutics, Inc. | 17/03/2021 | 20210317 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04805671 | Recruiting | No | 18 Years | N/A | All | July 26, 2021 | 1084 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | United States;Ukraine;South Africa;Poland;Hungary;Greece;Germany;Bulgaria;Brazil;Argentina;Ukraine;South Africa;Poland;Hungary;Greece;Germany;Bulgaria;Brazil;Argentina→Argentina;Brazil;Bulgaria;Germany;Greece;Hungary;Poland;Romania;South Africa;Ukraine;Argentina;Brazil;Bulgaria;Germany;Greece;Hungary;Poland;Romania;South Africa;Ukraine;United States | | Study Inquiry | | ClinicalTrials@adagiotx.com | +1 781-819-0080 | |
<br> Inclusion Criteria:
<br>
<br> - Has had SARS-CoV-2 positive antigen, RT-PCR, or other locally approved molecular
<br> diagnostic assay obtained within 5 days prior to randomization
<br>
<br> - Has had symptoms consistent with COVID-19 with onset 5 days before randomization
<br>
<br> - Has one or more COVID-19-related signs or symptoms on the day of randomization
<br>
<br> - Is > 55 years of age or is 18 to =55 years of age with one or more preexisting medical
<br> conditions that place the participant at high risk of progression of COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> - Is currently hospitalized or in the opinion of the investigator is anticipated to
<br> require hospitalization within 48 hours of randomization.
<br>
<br> - Has severe COVID-19 or is on supplemental oxygen
<br>
<br> - Has a history of a positive SARS-CoV-2 antibody serology test
<br>
<br> - Has participated, within the last 30 days, in a clinical study involving an
<br> investigational intervention
<br>
<br> - Has received a SARS-CoV-2 vaccine, monoclonal antibody, or plasma from a person who
<br> recovered from COVID-19 any time prior to participation in the study
<br>
<br> NOTE: Other protocol defined inclusion/exclusion criteria apply
<br> | | COVID-19 | Drug: ADG20;Drug: Normal saline | Changes from baseline in vital signs (body temperature, heart rate, respiration rate, and systolic and diastolic blood pressure);Changes from baseline in clinical laboratory tests (ie, CBC with differential, serum chemistry, coagulation);Incidence of solicited injection site reactions;Incidence of treatment-emergent adverse events;Incidence of COVID-19 related hospitalizations or all-cause death | | | | Yes | False | | |
| → | NCT04815031 | 1 November 2021→15 November 2021 | Drug Use Investigation of COMIRNATY Intramuscular Injection | General Investigation of COMIRNATY Intramuscular Injection (Follow-up Study for Subjects [Healthcare Professionals] Who Are Vaccinated at an Early Post-Approval Stage) | | Pfizer | 22/03/2021 | 20210322 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04815031 | Recruiting | No | 16 Years | N/A | All | April 20, 2021 | 20000 | Observational | | | Japan | ; | Pfizer CT.gov Call Center;Pfizer CT.gov Call Center | | ;ClinicalTrials.gov_Inquiries@pfizer.com | ;1-800-718-1021 | Pfizer; |
<br> Inclusion Criteria:
<br>
<br> - Subjects who have participated in the Investigation of Health Status of Recipients
<br> Vaccinated First and have provided written consent to continue participation in this
<br> study.
<br>
<br> Exclusion Criteria:
<br>
<br> - No exclusion criteria.
<br> | | COVID-19 | Biological: BNT162b2 | Proportion of subjects with severe COVID-19;Number of subjects with severe COVID-19;Proportion of subjects withe serious Adverse Events;The number of subjects with serious Adverse Events | | | | Yes | False | | |
| → | NCT04816019 | 18 October 2021→15 November 2021 | A Study of Intranasal ChAdOx1 nCOV-19 | A Phase I Study to Determine Safety, Tolerability and Immunogenicity of Intranasal Administration of the COVID Vaccine ChAdOx1 nCOV-19 in Healthy UK Adults | | University of Oxford | 15/03/2021 | 20210315 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04816019 | Recruiting | No | 18 Years | 55 Years | All | April 1, 2021 | 54 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1 | United Kingdom | ; ; | Alexander Douglas, Dr;Volunteer Recruitment Coordinator;Volunteer Coordinator | | ;vaccinetrials@ndm.oc.ac.uk;vaccinetrials@ndm.ox.ac.uk | ;001865 611424; | University of Oxford; |
<br> Inclusion Criteria:
<br>
<br> - Groups 1, 2 and 3 only: Healthy adults aged 18-55 years (Note, prior to implementation
<br> of SA001, a single participant under the age of 30 was enrolled in group 1a. This
<br> participant will be retained for follow-up but will not receive a booster vaccine, in
<br> light of the new age restrictions. Between the implementation of SA001 and
<br> implementation of SA003, only those aged 30-40 years were eligible.
<br>
<br> - Groups 4 and 5 only: Healthy adults aged 30-55 years
<br>
<br> - Able and willing (in the Investigator's opinion) to comply with all study requirements
<br>
<br> - Willing to allow the investigators to discuss the volunteer's medical history with
<br> their General Practitioner and access all medical records when relevant to study
<br> procedures.
<br>
<br> - For females only, willingness to practice continuous effective contraception during
<br> the study and a negative pregnancy test on the day(s) of screening and vaccination.
<br>
<br> - Agreement to refrain from blood donation during the course of the study.
<br>
<br> - Provide written informed consent.
<br>
<br> - Group 4 only: Prior receipt of 2 doses of ChAdOx1 nCoV-19 intramuscularly, with an
<br> interval of at least 8 weeks between the intramuscular doses, and with the second dose
<br> a minimum of 12 weeks prior to enrolment
<br>
<br> - Group 5 only: Prior receipt of 2 doses of BNT162b2 intramuscularly, with an interval
<br> of at least 3 weeks between the intramuscular doses, and with the second dose a
<br> minimum of 12 weeks prior to enrolment
<br>
<br> Acceptable forms of contraception for female volunteers include:
<br>
<br> - Established use of oral, injected or implanted hormonal methods of contraception.
<br>
<br> - Placement of an intrauterine device (IUD) or intrauterine system (IUS).
<br>
<br> - Total abdominal hysterectomy.
<br>
<br> - Bilateral tubal Occlusion Barrier methods of contraception (condom or occlusive cap
<br> with spermicide).
<br>
<br> - Male sterilisation, if the vasectomised partner is the sole partner for the subject.
<br>
<br> - True abstinence, when this is in line with the preferred and usual lifestyle of the
<br> subject.
<br>
<br> - Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation
<br> methods), declaration of abstinence for the duration of exposure to IMP, and
<br> withdrawal are not acceptable methods of contraception
<br>
<br> Exclusion Criteria:
<br>
<br> - Receipt or planned receipt of any vaccine other than the study intervention within 28
<br> days before and after each study vaccination.
<br>
<br> - Participation in COVID-19 prophylactic drug trials for the duration of the study.
<br> (Note: Participation in COVID-19 treatment trials is allowed in the event of
<br> hospitalisation due to COVID-19. The study team should be informed as soon as
<br> possible.)
<br>
<br> - Groups 1, 2 and 3 only: Prior receipt of an investigational or licensed vaccine likely
<br> to impact on interpretation of the trial data (e.g. Adenovirus vectored vaccines, any
<br> coronavirus vaccines).
<br>
<br> - Administration of immunoglobulins and/or any blood products within the three months
<br> preceding the planned administration of the vaccine candidate.
<br>
<br> - Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV
<br> infection; asplenia; recurrent severe infections and use of immunosuppressant
<br> medication within the past 6 months, except topical steroids or short-term oral
<br> steroids (course lasting <14 days).
<br>
<br> - Any autoimmune conditions, except mild psoriasis, well-controlled autoimmune thyroid
<br> disease, vitiligo or stable coeliac disease not requiring immunosuppressive or
<br> immunomodulatory therapy.
<br>
<br> - History of allergic disease or reactions likely to be exacerbated by any component of
<br> ChAdOx1 nCoV-19.
<br>
<br> - Any history of angioedema.
<br>
<br> - Any history of anaphylaxis.
<br>
<br> - Pregnancy, lactation or willingness/intention to become pregnant during the study.
<br>
<br> - History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in
<br> situ).
<br>
<br> - History of any organic central nervous system disorder or any functional disorder
<br> involving neurological symptoms
<br>
<br> - History of serious psychiatric condition likely to affect participation in the study
<br> (e.g. ongoing severe depression, history of admission to an in-patient psychiatric
<br> facility, recent suicidal ideation, history of suicide attempt, bipolar disorder,
<br> personality disorder, alcohol and drug dependency, severe eating disorder, psychosis,
<br> use of mood stabilisers or antipsychotic medication).
<br>
<br> - Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or
<br> prior history of significant bleeding or bruising following IM injections or
<br> venepuncture, or continuous anticoagulation e.g. with warfarin
<br>
<br> - History of confirmed major thrombotic event (including cerebral venous sinus
<br> thrombosis, deep vein thrombosis, pulmonary embolism), or
<br>
<br> - History of antiphospholipid syndrome
<br>
<br> - Prior receipt of unfractionated heparin
<br>
<br> - History of heparin induced thrombocytopenia
<br>
<br> - Any other serious chronic illness requiring hospital specialist supervision.
<br>
<br> - Chronic respiratory diseases, including mild asthma (resolved childhood asthma is
<br> allowed).
<br>
<br> - Chronic cardiovascular disease (including hypertension), gastrointestinal disease,
<br> liver disease (except Gilberts Syndrome), renal disease, endocrine disorder (including
<br> diabetes) and neurological illness (excluding migraine).
<br>
<br> - Nasal pathology (e.g. congenital abnormalities such as an abnormal septum or polyps,
<br> previous cauterisation, rhinoplasty or nasal surgery of any kind, recurrent
<br> epistaxis).
<br>
<br> - Seriously overweight (BMI=40 Kg/m2) or underweight (BMI=18 Kg/m2).
<br>
<br> - Suspected or known current alcohol abuse as defined by an alcohol intake of greater
<br> than 42 units every week.
<br>
<br> - Suspected or known injecting drug abuse in the 5 years preceding enrolment.
<br>
<br> - Any clinically significant abnormal finding on screening biochemistry, haematology
<br> blood tests or urinalysis.
<br>
<br> - Any other significant disease, disorder or finding which may significantly increase
<br> the risk to the volunteer because of participation in the study, affect the ability of
<br> the volunteer to participate in the study or impair interpretation of the study data.
<br>
<br> - Groups 1, 2 and 3 only: Living in the same household as any vulnerable groups at risk
<br> of severe COVID-19 disease (as per PHE guidance).
<br>
<br> - Groups 1, 2 and 3 only: Membership of any group identified by JCVI at the time of
<br> enrolment as being eligible for priority vaccinati | | Coronavirus | Biological: ChAdOx1 nCov-19 | Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of serious adverse events (SAEs);Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of adverse events as identified by change in baseline safety laboratory measures;Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of unsolicited signs and symptoms;Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of solicited signs and symptoms→Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of solicited signs and symptoms;Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of unsolicited signs and symptoms;Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of adverse events as identified by change in baseline safety laboratory measures;Investigate the safety and tolerability of intranasal administration of ChAdOx1 nCov-19 in healthy adult volunteers: Occurrence of serious adverse events (SAEs) | | | | Yes | False | | |
| → | NCT04816643 | 11 October 2021→15 November 2021 | A Phase 1/2/3 Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children and Young Adults | PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN and Young Adults→PHASE 1, OPEN-LABEL DOSE-FINDING STUDY TO EVALUATE SAFETY, TOLERABILITY, AND IMMUNOGENICITY AND PHASE 2/3 PLACEBO-CONTROLLED, OBSERVER-BLINDED SAFETY, TOLERABILITY, AND IMMUNOGENICITY STUDY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY CHILDREN AND YOUNG ADULTS | | BioNTech SE | 19/03/2021 | 20210319 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04816643 | Recruiting | Yes | 6 Months | 30 Years | All | March 24, 2021 | 7922→11422 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 2/Phase 3 | United States;Spain;Poland;Finland;Spain;Poland;Finland;United States→United States;Finland;Poland;Spain;Finland;Poland;Spain;United States | ; | Pfizer CT.gov Call Center;Pfizer CT.gov Call Center | | ;ClinicalTrials.gov_Inquiries@pfizer.com | ;1-800-718-1021 | Pfizer; |
<br> Inclusion Criteria
<br>
<br> 1. Male or female participants =6 months to <12 years of age, at the time of
<br> randomization, at Visit 1 for the dose-finding/selected-dose evaluation and for
<br> participants =5 to <30 years of age, at the time of randomization, at Visit 1 for the
<br> lower-dose evaluation.
<br>
<br> 2. Participants' parent(s)/legal guardian(s) and participants, as age appropriate, who
<br> are willing and able to comply with all scheduled visits, treatment plan, laboratory
<br> tests, lifestyle considerations, and other study procedures.
<br>
<br> 3. Healthy participants who are determined by medical history, physical examination, and
<br> clinical judgment of the investigator to be eligible for inclusion in the study.
<br>
<br> Note: Healthy participants with preexisting stable disease, defined as disease not
<br> requiring significant change in the therapy or hospitalization for worsening disease
<br> during the 6 weeks before enrollment, can be included.
<br>
<br> 4. Participants are expected to be available for the duration of the study and whose
<br> parent(s)/legal guardian can be contacted by telephone during study participation.
<br>
<br> 5. Negative urine pregnancy test for female participants who are biologically capable of
<br> having children.
<br>
<br> 6. Female participant of childbearing potential or male participant able to father
<br> children who is willing to use a highly effective method of contraception as outlined
<br> in this protocol for at least 28 days after the last dose of study intervention if at
<br> risk of pregnancy with her/his partner; or female participant not of childbearing
<br> potential or male participant not able to father children.
<br>
<br> 7. The participant or participant's parent(s)/legal guardian is capable of giving signed
<br> informed consent, which includes compliance with the requirements and restrictions
<br> listed in the ICD and in this protocol. Depending on the age of the participant and
<br> according to local requirements, participants will also be asked to provide assent as
<br> appropriate (verbal or written).
<br>
<br> Exclusion Criteria
<br>
<br> 1. Phase 1 only: Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2
<br> NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs
<br> and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
<br>
<br> 2. Phase 1 only: Known infection with HIV, HCV, or HBV.
<br>
<br> 3. Receipt of medications intended to prevent COVID-19.
<br>
<br> 4. Previous or current diagnosis of MIS-C.
<br>
<br> 5. Other medical or psychiatric condition including recent (within the past year) or
<br> active suicidal ideation/behavior or laboratory abnormality that may increase the risk
<br> of study participation or, in the investigator's judgment, make the participant
<br> inappropriate for the study. Note: This includes both conditions that may increase the
<br> risk associated with study intervention administration or a condition that may
<br> interfere with the interpretation of study results
<br>
<br> 6. History of severe adverse reaction associated with a vaccine and/or severe allergic
<br> reaction (eg, anaphylaxis) to any component of the study intervention(s).
<br>
<br> 7. Immunocompromised individuals with known or suspected immunodeficiency, as determined
<br> by history and/or laboratory/physical examination.
<br>
<br> 8. Individuals with a history of autoimmune disease or an active autoimmune disease
<br> requiring therapeutic intervention, including but not limited to systemic lupus
<br> erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
<br>
<br> 9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the
<br> opinion of the investigator, contraindicate intramuscular injection.
<br>
<br> 10. Female who is pregnant or breastfeeding.
<br>
<br> 11. Previous vaccination with any coronavirus vaccine.
<br>
<br> 12. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic
<br> agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or
<br> planned receipt throughout the study. If systemic corticosteroids have been
<br> administered short term (<14 days) for treatment of an acute illness, participants
<br> should not be enrolled into the study until corticosteroid therapy has been
<br> discontinued for at least 28 days before study intervention administration.
<br> Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes)
<br> corticosteroids are permitted.
<br>
<br> 13. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60
<br> days before study intervention administration, or receipt of any passive antibody
<br> therapy specific to COVID-19 from 90 days before study intervention administration, or
<br> planned receipt throughout the study.
<br>
<br> 14. Participation in other studies involving study intervention within 28 days prior to
<br> study entry and/or during study participation.
<br>
<br> 15. Previous participation in other studies involving study intervention containing LNPs.
<br>
<br> 16. Participants who are direct descendants (child or grandchild) of investigational site
<br> staff members or Pfizer/BioNTech employees directly involved in the conduct of the
<br> study, site staff otherwise supervised by the investigator, and their respective
<br> family members.
<br> →
<br> Inclusion Criteria
<br>
<br> 1. Male or female participants =6 months to <12 years of age, at the time of
<br> randomization, at Visit 1 for the dose-finding/selected-dose evaluation and for
<br> participants =5 to <30 years of age, at the time of randomization, at Visit 1 for the
<br> lower-dose evaluation. For the obtaining-serum-samples-for-potential-troponin
<br> I-testing portion of the study: Male or female participants between =5 and <16 years
<br> of age.
<br>
<br> 2. Participants' parent(s)/legal guardian(s) and participants, as age appropriate, who
<br> are willing and able to comply with all scheduled visits, treatment plan, laboratory
<br> tests, lifestyle considerations, and other study procedures.
<br>
<br> 3. Healthy participants who are determined by medical history, physical examination, and
<br> clinical judgment of the investigator to be eligible for inclusion in the study.
<br>
<br> Note: Healthy participants with preexisting stable disease, defined as disease not
<br> requiring significant change in the therapy or hospitalization for worsening disease
<br> during the 6 weeks before enrollment, can be included.
<br>
<br> 4. Participants are expected to be available for the duration of the study and whose
<br> parent(s)/legal guardian can be contacted by telephone during study participation.
<br>
<br> 5. Negative urine pregnancy test for female participants who are biologically capable of
<br> having children.
<br>
<br> 6. Female participant of childbearing potential or male participant able to father
<br> children who is willing to use a highly effective method of contraception as outlined
<br> in this protocol for at least 28 days after the last dose of study intervention if at
<br> risk of pregnancy with her/his partner; or female participant not of childbearing
<br> potential or male participant not able to father children.
<br>
<br> 7. The participant or participant's parent(s)/legal guardian is capable of giving signed
<br> informed consent, which includes compliance with the requirements and restrictions
<br> listed in the ICD and in this protocol. Depending on the age of the participant and
<br> according to local requirements, participants will also be asked to provide assent as
<br> appropriate (verbal or written).
<br>
<br> Exclusion Criteria
<br>
<br> 1. Phase 1 only: Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2
<br> NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs
<br> and a positive SARS-CoV-2 NAAT result) diagnosis of COVID 19.
<br>
<br> 2. Phase 1 only: Known infection with HIV, HCV, or HBV.
<br>
<br> 3. Receipt of medications intended to prevent COVID-19.
<br>
<br> 4. Previous or current diagnosis of MIS-C.
<br>
<br> 5. Other medical or psychiatric condition including recent (within the past year) or
<br> active suicidal ideation/behavior or laboratory abnormality that may increase the risk
<br> of study participation or, in the investigator's judgment, make the participant
<br> inappropriate for the study. Note: This includes both conditions that may increase the
<br> risk associated with study intervention administration or a condition that may
<br> interfere with the interpretation of study results
<br>
<br> 6. History of severe adverse reaction associated with a vaccine and/or severe allergic
<br> reaction (eg, anaphylaxis) to any component of the study intervention(s).
<br>
<br> 7. Immunocompromised individuals with known or suspected immunodeficiency, as determined
<br> by history and/or laboratory/physical examination.
<br>
<br> 8. Individuals with a history of autoimmune disease or an active autoimmune disease
<br> requiring therapeutic intervention, including but not limited to systemic lupus
<br> erythematosus. Note: Stable type 1 diabetes and hypothyroidism are permitted.
<br>
<br> 9. Bleeding diathesis or condition associated with prolonged bleeding that would, in the
<br> opinion of the investigator, contraindicate intramuscular injection.
<br>
<br> 10. Female who is pregnant or breastfeeding.
<br>
<br> 11. Previous vaccination with any coronavirus vaccine.
<br>
<br> 12. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic
<br> agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or
<br> planned receipt throughout the study. If systemic corticosteroids have been
<br> administered short term (<14 days) for treatment of an acute illness, participants
<br> should not be enrolled into the study until corticosteroid therapy has been
<br> discontinued for at least 28 days before study intervention administration.
<br> Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes)
<br> corticosteroids are permitted.
<br>
<br> 13. Receipt of blood/plasma products, immunoglobulin, or monoclonal antibodies, from 60
<br> days before study intervention administration, or receipt of any passive antibody
<br> therapy specific to COVID-19 from 90 days before study intervention administration, or
<br> planned receipt throughout the study.
<br>
<br> 14. Participation in other studies involving study intervention within 28 days prior to
<br> study entry and/or during study participation.
<br>
<br> 15. Previous participation in other studies involving study intervention containing LNPs.
<br>
<br> 16. Participants who are direct descendants (child or grandchild) of investigational site
<br> staff members or Pfizer/BioNTech employees directly involved in the conduct of the
<br> study, site staff otherwise supervised by the investigator, and their respective
<br> family members.
<br> | | SARS-CoV-2 Infection, COVID-19 | Biological: Biological/Vaccine: BNT162b2 10mcg;Biological: BNT162b2 20mcg;Biological: BNT162b2 30mcg;Other: Placebo;Biological: Biological/Vaccine: BNT162b2 3mcg | In Phase 2/3 selected-dose participants, the difference in percentages of participants with seroresponse in participants =6 months to <2 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001;In Phase 2/3 selected-dose participants, the difference in percentages of participants with seroresponse in participants =2 to <5 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study;In Phase 2/3 selected-dose participants, the difference in percentages of participants with seroresponse in participants =5 to <12 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study;Ph 2/3 selected-dose participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants =6 months to <2 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in C4591001 study;Ph 2/3 selected-dose participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants =2 to <5 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in the C4591001 study;Ph 2/3 selected-dose participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants =5 to <12 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in the C4591001 study;Percentage of participants in Phase 2/3 reporting serious adverse events;Percentage of participants in Phase 2/3 reporting adverse events;Percentage of participants in Phase 2/3 reporting systemic events;Percentage of participants in Phase 2/3 reporting local reaction;Percentage of participants in Phase 1 reporting serious adverse events;Percentage of participants in Phase 1 reporting adverse events;Percentage of participants in Phase 1 reporting systemic events;Percentage of participants in Phase 1 reporting local reactions→Percentage of participants in Phase 1 reporting local reactions;Percentage of participants in Phase 1 reporting systemic events;Percentage of participants in Phase 1 reporting adverse events;Percentage of participants in Phase 1 reporting serious adverse events;Percentage of participants in Phase 2/3 reporting local reaction;Percentage of participants in Phase 2/3 reporting systemic events;Percentage of participants in Phase 2/3 reporting adverse events;Percentage of participants in Phase 2/3 reporting serious adverse events;Ph 2/3 selected-dose participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants =5 to <12 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in the C4591001 study;Ph 2/3 selected-dose participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants =2 to <5 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in the C4591001 study;Ph 2/3 selected-dose participants, immunobridging of SARS-CoV-2 serum neutralizing titers after 2 doses in participants =6 months to <2 years to the geometric mean of SARS-CoV-2 serum neutralizing titers in participants 16 to 25 years in C4591001 study;In Phase 2/3 selected-dose participants, the difference in percentages of participants with seroresponse in participants =5 to <12 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study;In Phase 2/3 selected-dose participants, the difference in percentages of participants with seroresponse in participants =2 to <5 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 study;In Phase 2/3 selected-dose participants, the difference in percentages of participants with seroresponse in participants =6 months to <2 years of age and participants 16 to 25 years of age from Phase 2/3 of the C4591001 | | | | Yes | True | parent | |
| → | NCT04818489 | 26 July 2021→15 November 2021 | Colchicine and Post-COVID-19 Pulmonary Fibrosis | Impact of Colchicine on the Clinical Outcome of COVID-19 and the Development of Post-COVID-19 Pulmonary Fibrosis: Randomized Controlled Clinical Trial | | ClinAmygate | 13/02/2021 | 20210213 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04818489 | Recruiting→Not recruiting | No | 18 Years | N/A | All | March 25, 2021 | 250→260 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | Phase 4 | Egypt | ; → | Emad Issak;Mariam Maged, MD→Emad Issak | | ;mariamaged@yahoo.com→ | ;01224532769→ | Ain Shams Univeristy |
<br> Inclusion Criteria:
<br>
<br> - Patients who are confirmed to have COVID-19 clinically, radiologically and PCR
<br>
<br> - Age above 18 years old
<br>
<br> - Informed written consent
<br>
<br> Exclusion Criteria:
<br>
<br> - History of hypersensitivity to colchicine
<br>
<br> - Pregnancy or breastfeeding women.
<br>
<br> - Patients with severe renal impairment (creatinine clearance (CCL) <30 mL / min)
<br>
<br> - Patients with severe hepatic impairment (AST or ALT> 5 times the normal limits in
<br> International Units (ULN)
<br>
<br> - Patients with blood dyscrasias, neutrophils <1.000 / mmc or platelets <50.000 / mmc
<br>
<br> - Patients with history of severe cardiac insufficiency
<br>
<br> - Patients with history of pulmonary fibrosis
<br>
<br> - Severe diarrhoea or bowel diverticulitis, or perforation
<br>
<br> - Patients who cannot take oral therapy
<br>
<br> - Patients already in ICU or requiring mechanical ventilation
<br>
<br> - Patients already enrolled in other clinical trials
<br>
<br> - Patients with taking P-glycoprotein inhibitor (e.g. ciclosporin, verapamil or
<br> quinidine) or a CYP3A4 inhibitor (e.g. ritonavir, remdesivir, atazanavir, indinavir,
<br> clarithromycin, telithromycin, itraconazole or ketaconazole) or Tocilizumab
<br> | | Covid19;Pulmonary Fibrosis Interstitial | Drug: Colchicine 0.5 MG;Other: the standard protocol only | Clinical status;Pulmonary fibrosis at week 2;Pulmonary fibrosis at 45 days | | | | Yes | False | | |
| → | NCT04818801 | 7 September 2021→15 November 2021 | Safety, Reactogenicity and Immunogenicity Study of ReCOV | A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of ReCOV, a Vaccine for COVID-19, in Healthy Adult Subjects | | Jiangsu Rec-Biotechnology Co., Ltd. | 19/03/2021 | 20210319 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04818801 | Recruiting | No | 18 Years | 80 Years | All | June 18, 2021 | 160→100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Early Phase 1 | New Zealand | | Christopher Wynne, doctor | | chris@ccst.co.nz | +6433729477 | |
<br> Inclusion Criteria:
<br>
<br> Subjects are eligible to be included in the study only if ALL of the following criteria
<br> apply at any time starting from Screening up to Day 1 prior to IP administration:
<br>
<br> 1. Capable of giving signed informed consent, which includes compliance with the
<br> requirements and restrictions listed in the Informed Consent Form (ICF) and in this
<br> protocol.
<br>
<br> 2. Male or female subjects who are =18 years old at the time of Screening (signing the
<br> ICF):
<br>
<br> 1. For the younger adult group: 18 to 55 years, inclusive
<br>
<br> 2. For the older adult group: =56 to <80 years
<br>
<br> 3. Have a body mass index (BMI) between 18.5 and 35.0 kg/m2.
<br>
<br> 4. Subjects who are of general good health according to the Investigator's assessment,
<br> based on a complete medical history without major pathology, and as determined by
<br> medical evaluation (including physical examination, electrocardiogram (ECG), vital
<br> signs, and clinical laboratory tests). Subjects in the older adult population who have
<br> medically stable, well-controlled comorbidities may be enrolled at the discretion of
<br> the Investigator.
<br>
<br> NOTE: All clinical laboratory values should be within reference ranges unless
<br> confirmed by Investigator or delegate as not clinically significant. One repeat
<br> evaluation of ECG, vital signs, and clinical laboratory tests will be permitted, at
<br> the discretion of the Investigator.
<br>
<br> 5. Subjects who test negative for hepatitis B surface antigen (HBsAg), hepatitis B core
<br> antibodies (anti-HBc), anti-hepatitis C virus (HCV) antibodies, and anti-human
<br> immunodeficiency virus (HIV) 1 and 2 antibodies at Screening.
<br>
<br> 6. Subjects who test negative for SARS-Cov-2 infection, based on a reverse transcriptase
<br> polymerase chain reaction (RT-PCR) test and serological test for SARS-COV-2 IgM and/or
<br> IgG antibodies at Screening.
<br>
<br> 7. Female subjects are eligible to participate if not pregnant, not breastfeeding, and at
<br> least 1 of the following conditions applies:
<br>
<br> 1. Is not a woman of childbearing potential (WOCBP), defined as:
<br>
<br> Surgically sterile (documented hysterectomy, bilateral salpingectomy, or
<br> bilateral oophorectomy, as confirmed by review of the subject's medical records,
<br> medical examination, or medical history interview), or Postmenopausal (defined as
<br> no menses for 12 months without an alternative medical cause. A high
<br> follicle-stimulating hormone [FSH] level in the postmenopausal range may be used
<br> to confirm a postmenopausal state in women not using hormonal contraception or
<br> hormonal replacement therapy [HRT]. However, in the absence of 12 months of
<br> amenorrhea, a single FSH measurement is insufficient). Female subjects on HRT and
<br> whose menopausal status is in doubt will be required to use 1 of the non estrogen
<br> hormonal highly effective contraception methods from Day 1 until at least 6
<br> months after the second dose of IP if they wish to continue their HRT during the
<br> study. Otherwise, they must discontinue HRT to allow confirmation of
<br> postmenopausal status before study enrollment.
<br>
<br> 2. Is a WOCBP who agrees to use a highly effective method of contraception
<br> consistently and correctly from Day 1 until at least 6 months after the second
<br> dose of IP.
<br>
<br> 8. Nonsterilized male subjects with female partners of childbearing potential are
<br> eligible to participate if they agree to ONE of the following from Day 1 until at
<br> least 6 months after the second dose of IP and refrain from donating sperm during this
<br> period:
<br>
<br> 1. Are abstinent from penile-vaginal intercourse as their usual and preferred
<br> lifestyle (abstinent on a long-term and persistent basis) and agree to remain
<br> abstinent.
<br>
<br> 2. Agree to use a male condom and have their partner use of a contraceptive method
<br> with a failure rate of <1% per year when having penile-vaginal intercourse with a
<br> WOCBP who is not currently pregnant.
<br>
<br> 3. Male subjects with a pregnant or breastfeeding partner must agree to remain
<br> abstinent from penile-vaginal intercourse or use a male condom during each
<br> episode of penile penetration.
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects are excluded from the study if ANY of the following criteria apply at any
<br> time starting from Screening up to Day 1 prior to IP administration:
<br>
<br> 1. History of clinically significant and uncontrolled hematological, renal,
<br> endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or
<br> neurologic disease in the opinion of the Investigator within 12 months prior to
<br> Screening.
<br>
<br> 2. Individuals with behavioral or cognitive impairment in the opinion of the
<br> Investigator.
<br>
<br> 3. Individuals with any progressive or severe neurologic disorder, seizure disorder,
<br> or history of Guillain-Barré syndrome.
<br>
<br> 4. Individuals with known or suspected impairment of the immune system, such as:
<br>
<br> 1. Use of systemic (oral or parenteral) corticosteroids for =14 consecutive
<br> days within 60 days prior to Day 1. Use of inhaled, intranasal, or topical
<br> corticosteroids is allowed. NOTE: Systemic (oral or parenteral)
<br> corticosteroids are also prohibited for 3 weeks after the second dose of the
<br> IP.
<br>
<br> 2. Receipt of cancer chemotherapy within 5 years prior to Day 1.
<br>
<br> 3. Receipt of immunostimulants or immunosuppressants within 60 days prior to
<br> Day 1.
<br>
<br> 4. Known HIV or acquired immune deficiency syndrome.
<br>
<br> 5. Subjects with active or prior documented autoimmune disorder (such as
<br> potential immune mediated diseases [pIMDs]).
<br>
<br> 6. Receipt of parenteral immunoglobulin preparation, blood products, and/or
<br> plasma derivatives within 3 months prior to Day 1 or planned during the full
<br> length of the study.
<br>
<br> 7. Being treated for tuberculosis.
<br>
<br> 5. History of allergic disease or reactions associated with previous vaccinations or
<br> likely to be exacerbated by any component of the IP.
<br>
<br> 6. Individuals who have had a previous confirmed or suspected illness caused by
<br> SARS-CoV-1, SARS-CoV-2, or MERS-CoV.
<br>
<br> 7. Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or
<br> lymphoproliferative disorder within the past 5 years from the first dose of the
<br> IP (Day 1).
<br>
<br> 8. History of urticaria within 1 year prior to Screening. | | Covid19 | Biological: Recombinant two-component COVID-19 vaccine (CHO cell);Other: Placebo | Number of Participants with solicited local and systemic adverse events;Number of Participants with unsolicited adverse events after each dose;Number of Participants with serious adverse events;Number of Participants with changes in clinical laboratory tests from baseline;Number of Participants with changes in vital signs from baseline | | | | Yes | False | | |
| → | NCT04821986 | 30 August 2021→15 November 2021 | Oral Manifestation in Patients With SARS-CoV2 Infection. | Oral Manifestation in Patients With SARS-CoV2 Infection. | | Fayoum University | 29/03/2021 | 20210329 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04821986 | Recruiting→Not recruiting | No | 18 Years | 60 Years | All | April 1, 2021 | 600→583 | Observational | | | Egypt | ; → | Alshaimaa A Mohamed, PhD;Alshaimaa A Shabaan, PhD→ | | aas16@fayoum.edu.eg;aas16@fayoum.edu.eg→ | +201006047940;+201006047940→ | |
<br> Inclusion Criteria:
<br>
<br> - A diagnosis of SARS-CoV2 with PCR.
<br>
<br> - Age range from 18-60 years old
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnancy or contraceptive pills
<br>
<br> - Lactation
<br>
<br> - Any auto-immune disease that could affect the oral mucosa
<br>
<br> - On any neoplastic therapy.
<br>
<br> - Uncontrolled diabetes
<br> | | SARS-CoV Infection | | oral manifestation | | | | Yes | False | | |
| → | NCT04821999 | 30 August 2021→15 November 2021 | Diode Laser 940 nm in Management of Loss of Taste Sensation | Diode Laser 940 nm in Management of Loss of Taste Sensation in Patients With Post SARS-CoV 2 Infection | | Fayoum University | 29/03/2021 | 20210329 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04821999 | Recruiting→Not recruiting | No | 18 Years | 60 Years | All | April 10, 2021 | 150→40 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). | N/A | Egypt | ; → | Alshaimaa Mohamed, PhD;Alshaimaa A Shabaan, PhD→ | | aas16@fayoum.edu.eg;aas16@fayoum.edu.eg→ | +201006047940;+201006047940→ | |
<br> Inclusion Criteria:
<br>
<br> A diagnosis of SARS-CoV2 with PCR. Age range from 18-60 years old Loss of taste sensation
<br>
<br> Exclusion Criteria:
<br>
<br> Pregnancy or contraceptive pills Lactation Any auto-immune disease that could affect the
<br> oral mucosa On any neoplastic therapy. Uncontrolled diabetes.
<br> | | SARS-CoV Infection | Device: a 940-nm diode laser | taste sensation survey | | | | Yes | False | | |
| → | NCT04822025 | 18 October 2021→15 November 2021 | A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Elderly Adults | A Phase II, Prospective, Randomized, Double-Blind, Dose-Comparison, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS-CoV-2 Vaccine Candidate MVC-COV1901 in Elderly Adults | | Medigen Vaccine Biologics Corp. | 25/03/2021 | 20210325 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04822025 | Not recruiting | No | 65 Years | N/A | All | May 20, 2021 | 400→420 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 2 | Taiwan | ; | Szu-Min Hsieh, MD;Tzou-Yien Lin, MD | | ; | ; | National Taiwan University Hospital;Chang Gang Memorial Hospital, LinKou |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female participant = 65 years of age at randomization.
<br>
<br> 2. Healthy adults or adults with pre-existing medical conditions who are in stable
<br> condition. A stable medical condition is defined as disease not requiring significant
<br> change in therapy or hospitalization for worsening disease 3 months before enrollment
<br> and expected to remain stable for the duration of the study.
<br>
<br> 3. Participant is willing and able to comply with all required study visits and follow-up
<br> required by this protocol.
<br>
<br> 4. Participant has not travelled overseas within 14 days of screening and will not have
<br> any oversea traveling throughout the study period.
<br>
<br> 5. Participant is able to understand and comply with study requirements/procedures (if
<br> applicable, with assistance by caregiver, surrogate, or legally authorized
<br> representative) based on the assessment of the investigator and must provide written
<br> informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Employees at the investigator's site, of the Sponsor or the contract research
<br> organization (CRO) who are directly involved in the conduct of the study.
<br>
<br> 2. Currently receiving or received any investigational intervention within 30 days prior
<br> to the first dose of study intervention.
<br>
<br> 3. Administered any licensed live-attenuated vaccines within 28 days or other licensed
<br> non-live-attenuated vaccines within 7 days prior to the first dose of study
<br> intervention.
<br>
<br> 4. Administered any blood product or intravenous (IV) immunoglobulin administration
<br> within 12 weeks prior to the first dose of study intervention.
<br>
<br> 5. Participant previously received any coronavirus vaccine.
<br>
<br> 6. Currently receiving or anticipate to receive concomitant immunosuppressive or
<br> immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing
<br> corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone
<br> less than 20 mg or equivalent) within 12 weeks prior to the first dose of study
<br> intervention.
<br>
<br> 7. Currently receiving or anticipate to receive treatment with tumor necrosis factor
<br> (TNF)-a inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to
<br> the first dose of study intervention.
<br>
<br> 8. Major surgery or any radiation therapy within 12 weeks prior to the first dose of
<br> study intervention.
<br>
<br> 9. Immunosuppressive illness or immunodeficient state, including hematologic malignancy,
<br> history of solid organ, bone marrow transplantation, or asplenia.
<br>
<br> 10. A history of malignancy with potential risk for recurrence after curative treatment,
<br> or current diagnosis of or treatment for cancer (exceptions are squamous and basal
<br> cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the
<br> discretion of the investigator).
<br>
<br> 11. Bleeding disorder considered a contraindication to intramuscular injection or
<br> phlebotomy.
<br>
<br> 12. Participant with known human immunodeficiency virus (HIV) infection or who is HIV
<br> antibody positive, with CD4 count < 350 cells/mm3 or a detectable HIV viral load
<br> within the past year (low level variations from 50-500 viral copies/mL or equivalent
<br> which do not lead to changes in antiretroviral therapy [ART] are permitted).
<br>
<br> 13. Participant who, in the investigator's judgement, is not in stable condition and by
<br> participating in the study could adversely affect the safety of the participant,
<br> interfere with adherence to study requirements or evaluation of any study endpoint.
<br> This may include aparticipant with ongoing acute diseases, severe infections,
<br> autoimmune disease, laboratory abnormality or serious medical conditions in the
<br> following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal,
<br> or psychiatric.
<br>
<br> 14. Participant with previous known SARS-CoV-1 or 2 infection or potential exposure to
<br> SARS-CoV-1 or 2 viruses (EXCEPT for those who have been tested negative or completed
<br> the self-managements/ home quarantines/ home isolations)
<br>
<br> 15. Participant with a history of hypersensitivity to any vaccine or a history of allergic
<br> disease or reactions likely to be exacerbated by any component of the MVC-COV1901.
<br>
<br> 16. Body (oral, rectal, or ear) temperature = 38.0°C or acute illness (not including minor
<br> illnesses such as diarrhea or mild upper respiratory tract infection at the discretion
<br> of the investigator) within 2 days before the first dose of study intervention.
<br> | | Covid19 Vaccine | Biological: MVC-COV1901 (High-Dose);Biological: MVC-COV1901(Mid-Dose) | Incidence of Adverse Events(AEs) [Safety and Tolerability];Immunogenicity of MVC-COV1901 | | | | Yes | False | | |
| → | NCT04822818 | 12 April 2021→15 November 2021 | EFFICACY and SAFETY OF BEVACIZUMAB (ZIRABEV®) IN PATIENTS WITH SEVERE HYPOXEMIC COVID-19 | TRIAL EVALUATING EFFICACY and SAFETY OF BEVACIZUMAB (ZIRABEV®) IN PATIENTS WITH SEVERE HYPOXEMIC COVID-19, NESTED IN THE CORIMUNO-19 COHORT | BEVA | Assistance Publique - Hôpitaux de Paris | 25/03/2021 | 20210325 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04822818 | Not recruiting→Recruiting | No | 18 Years | N/A | All | April 2021→April 17, 2021 | 174 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | →France | ; → ; ; | Jacques CADRANEL, PUPH;Jacques CADRANEL, PUPH→Jacques CADRANEL, PUPH;Jacques CADRANEL, PUPH;CADRANEL Jacques | | ;jacques.cadranel@aphp.fr→;jacques.cadranel@aphp.fr;jacques.cadranel@aphp.fr | ;0156016147→;0156016147; | Assistance Publique - Hôpitaux de Paris; |
<br> Inclusion Criteria:
<br>
<br> - Patients included in the CORIMUNO-19 cohort
<br>
<br> - Patients hospitalized in conventional ward or in the ICU belonging to the following
<br> groups: OMS Progression scale 6, 7, 8 AND no acute pulmonary embolism on CT-scan
<br> performed in the preceding 72 hours no pulmonary evident bacterial coinfection or
<br> superinfection evaluated by non-invasive procedures (serology, antigens, nasopharynx
<br> PCR, sputum examination, blood cultures…)
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients in OMS progression class 9
<br>
<br> - Patients with exclusion criteria to the CORIMUNO-19 cohort
<br>
<br> - Pregnancy
<br>
<br> - Active cancer with ongoing treatment
<br>
<br> - acute use of NIV for COPD exacerbation or cardiac decompensation associated to
<br> COVID-19
<br>
<br> - Oxygen patient requiring long-term oxygen before hospitalization
<br>
<br> - Patient already included in an interventional research
<br>
<br> - Risk of bleeding especially hemoptysis, active venous or arterial thromboembolic
<br> disease and recent surgery during the last 3 weeks
<br>
<br> - Hypersensitivity to the active substance (bevacizumab) or to any of the excipients
<br> (sucrose, succinic acid, disodium edetate, polysorbate 80, sodium hydroxide, water for
<br> injection
<br>
<br> - Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant
<br> human or humanised antibodies
<br>
<br> - Persistant uncontrolled arterial hypertension after using to anti-hypertensive drugs
<br> →
<br> Inclusion Criteria:
<br>
<br> - Patients included in the CORIMUNO-19 cohort
<br>
<br> - Patients hospitalized in conventional ward or in the ICU belonging to the following
<br> groups: OMS Progression scale 6, 7, 8 AND no acute pulmonary embolism on CT-scan
<br> performed in the preceding 72 hours no pulmonary evident bacterial coinfection or
<br> superinfection evaluated by non-invasive procedures (serology, antigens, nasopharynx
<br> PCR, sputum examination, blood cultures…)
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients in OMS progression class 9
<br>
<br> - Patients with exclusion criteria to the CORIMUNO-19 cohort
<br>
<br> - Pregnancy
<br>
<br> - Active cancer with ongoing treatment
<br>
<br> - acute use of NIV for COPD exacerbation or cardiac decompensation associated to
<br> COVID-19
<br>
<br> - Oxygen patient requiring long-term oxygen before hospitalization
<br>
<br> - Patient already included in an interventional research
<br>
<br> - Risk of bleeding especially hemoptysis, active venous or arterial thromboembolic
<br> disease and recent surgery during the last 3 weeks
<br>
<br> - Hypersensitivity to the active substance (bevacizumab) or to any of the excipients
<br> (sucrose, succinic acid, disodium edetate, polysorbate 80, sodium hydroxide, water for
<br> injection
<br>
<br> - Hypersensitivity to Chinese Hamster Ovary (CHO) cell products or other recombinant
<br> human or humanised antibodies
<br>
<br> - Persistant uncontrolled arterial hypertension after using to anti-hypertensive drugs
<br>
<br> - Current documented bacterial infection not controlled by antibiotics.
<br>
<br> - Active viral diseases (especially active herpes, chickenpox, shingles),
<br>
<br> - Active tuberculosis or disseminated strongyloidiasis
<br>
<br> - patient with known active hepatitis or with increased level of SGOT or SGPT =5N
<br>
<br> - Patient with anormal laboratory results: Absolute neutrophil count (ANC) = 1.0 x
<br> 109/L, Platelets (PLT) < 50 G /L
<br> | | Corona Virus Infection;SARS (Severe Acute Respiratory Syndrome);Virus Diseases;Coronaviridae Infections;Nidovirales Infections;RNA Virus Infections;Respiratory Tract Infections;Respiratory Tract Diseases | Drug: BEVA+SOC;Drug: SOC | The time to recovery for a category 0 to 5 on the WHO Progression scale | | | | Yes | False | | |
| → | NCT04823988 | 1 November 2021→15 November 2021 | Emotional, Social, Cognitive and Behavioral Sequalae of the COVID-19 Pandemic | Emotional, Social, Cognitive and Behavioral Sequalae of the COVID-19 Pandemic | | National Institute of Mental Health (NIMH) | 30/03/2021 | 20210330 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04823988 | Not recruiting | No | 18 Years | N/A | All | November 3, 2021→November 18, 2021 | 3000 | Observational | | | United States | ; | Monique Ernst, M.D.;Morgan Andrews, Ph.D. | | ;nimhhealthyvolunteer@nih.gov | ;Not Listed | National Institute of Mental Health (NIMH); |
<br> - INCLUSION CRITERIA:
<br>
<br> In order to be eligible to participate in this study, an individual must meet all of the
<br> following criteria:
<br>
<br> 1. 18 years of age and older.
<br>
<br> 2. Able to read and write English.
<br>
<br> 3. Able to provide informed consent online using study website.
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> 1. There are no exclusion criteria for this study.
<br> | | Healthy Volunteer | | Online self-report measures | | | | Yes | False | | |
| → | NCT04824469 | 24 May 2021→15 November 2021 | The Effects of Web-Based Training for Covid-19 Patients on Symptom Management, Medication Compliance and Quality of Life | The Effects of Web-Based Training and Telephone Follow-up Developed for Covid-19 Patients on Symptom Management, Medication Compliance and Quality of Life | | Eskisehir Osmangazi University | 25/03/2021 | 20210325 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04824469 | Not recruiting | No | 18 Years | N/A | All | May 2021→December 15, 2021 | 128 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Double (Participant, Outcomes Assessor). | N/A | | | Ebru Arslan Özdemir, PhD Student | | ebruaarslan@gmail.com | +90 531 420 96 53 | |
<br> Inclusion Criteria:
<br>
<br> - Over the age of 18,
<br>
<br> - Does not have a communication problem that prevents participation in research or
<br> education, such as inability to understand / speak Turkish,
<br>
<br> - Being literate,
<br>
<br> - Residing in Zonguldak province, applying to hospitals in the province and diagnosed
<br> with Covid-19 according to PCR (Polymerase Chain Reaction) test and Thorax CT (Thorax
<br> computed tomography) results by the radiation teams and deemed appropriate for home
<br> follow-up by the Zonguldak Public Health Directorate,
<br>
<br> - Having active Internet access and actively using a computer / tablet or smartphone,
<br>
<br> - Patients who agree to participate in the study
<br>
<br> Exclusion Criteria:
<br>
<br> - No internet connection at home or on the phone,
<br>
<br> - Do not know how to use internet and computers,
<br>
<br> - Having a communication problem that prevents participation in research or education,
<br> such as inability to understand / speak Turkish, Patients who were previously
<br> diagnosed with Covid-19 and treated at home or in hospital,
<br>
<br> - With severe insufficiency (Heart failure, Kidney failure, Immune system failure)
<br>
<br> - Illiterate individuals will not be included in the study.
<br> | | COVID-19 | Other: intervention group | Pre-intervention measurements;Pre-intervention measurements;Pre-intervention measurements | | | | Yes | False | | |
| → | NCT04828460 | 12 April 2021→15 November 2021 | Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients | Monitoring of COVID-19 Vaccine Response in Organ Transplant Patients | COVATRANS | University Hospital, Strasbourg, France | 31/03/2021 | 20210331 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04828460 | Recruiting | No | N/A | N/A | All | February 9, 2021 | 3500 | Observational | | | France | ; | Sophie Ohlmann, MD;Sophie Ohlmann, MD | | sophie.ohlmann@chru-strasbourg.fr;sophie.ohlmann@chru-strasbourg.fr | 0369551320;0369551320 | |
<br> Inclusion Criteria:
<br>
<br> - Patient, male or female, adult or child (15 years and older)
<br>
<br> - Patient vaccinated against SARS-CoV-2 as part of routine care, and having received the
<br> 2 injections
<br>
<br> - Solid organ transplant recipient
<br>
<br> - Transplantation for more than 3 months
<br>
<br> Exclusion Criteria:
<br>
<br> - History of anaphylactic shock or known allergy to PEG
<br>
<br> - Known history of COVID or positive Covid serology in the 3 months preceding inclusion
<br>
<br> - Formal contraindication to an intra-muscular injection
<br>
<br> - Impossibility to give the subject informed information (subject in emergency
<br> situation, difficulties in understanding the subject, ...)
<br>
<br> - Subject under legal protection
<br>
<br> - Subject under guardianship or curatorship
<br>
<br> - Patient having expressed his opposition to participate
<br> | | Covid19;Kidney Transplantation | | Percentage of patients who develop a seroconversion for SARS Cov-2 anti Spike antibodies | | | | Yes | False | | |
| → | NCT04841707 | 14 June 2021→15 November 2021 | Total-Body Parametric 18F-FDG PET of COVID-19 | Total-Body Parametric 18F-FDG PET of COVID-19 | | University of California, Davis | 31/03/2021 | 20210331 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04841707 | Recruiting | No | 18 Years | N/A | All | May 10, 2021 | 15 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label). | N/A | United States | ; ; | Guobao Wang, PhD;Lynda Painting;Lynda Painting, BS | | ;lpainting@ucdavis.edu;lpainting@ucdavis.edu | ;916-731-9004;916-731-9004 | University of California, Davis; |
<br> Inclusion Criteria:
<br>
<br> - COVID-19 positive patients will have a previous positive COVID-19 test and
<br> radiographic findings, and/or a positive SARS-CoV-2 antibody test and be in early
<br> recovery.
<br>
<br> - First PET/CT visit needs to be within 8 weeks of COVID-19 diagnosis.
<br>
<br> - Ability to understand and willingness to sign an informed consent form.
<br>
<br> - Ability to adhere to the study visit schedule and other protocol requirements.
<br>
<br> - All persons =18 years of age.
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnant or lactating women.
<br>
<br> - Any condition that would prohibit the understanding or rendering of informed consent.
<br>
<br> - Unable to lie supine for 1-hour imaging with PET.
<br>
<br> - Prisoners.
<br>
<br> - Any comorbidity that, in the opinion of the investigator, could compromise protocol
<br> objectives.
<br> | | Covid19 | Device: uEXPLORER/mCT | BAB permeability assessed | | | | Yes | False | | |
| → | NCT04841759 | 30 August 2021→15 November 2021 | The Effects of a Multi-factorial Rehabilitation Program for Healthcare Workers Suffering From Post-COVID-19 Fatigue Syndrome | The Effects of a Multi-factorial Rehabilitation Program for Healthcare Workers Suffering From Post-COVID-19 Fatigue Syndrome | | Medical University of Vienna | 07/04/2021 | 20210407 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04841759 | Recruiting→Not recruiting | No | 18 Years | 65 Years | All | April 1, 2021 | 64 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Participant). | N/A | Austria | ; → | Richard Crevenna, Prof. MD, MBA, MMSc;no central PRS Administrator→ | | richard.crevenna@meduniwien.ac.at;→ | +43 1 40400;→ | |
<br> Inclusion Criteria:
<br>
<br> - Employees of the Medical University of Vienna, Austria or the General Hospital of
<br> Vienna, Austria
<br>
<br> - survived COVID-19 infection
<br>
<br> Exclusion Criteria:
<br>
<br> - acute COVID-19 infection
<br>
<br> - serious, uncontrolled diseases of the cardiovascular system
<br>
<br> - insufficient language skills to complete the study requirements
<br> | | COVID-19 | Other: Exercise | Change of maximum oxygen uptake (VO2max) over time-points (baseline - 4 weeks - 8 weeks) assessed during cardio-pulmonary exercise testing (CPET) | | | | Yes | False | | |
| → | NCT04842747 | 1 November 2021→15 November 2021 | VERU-111 in the Treatment of SARS-Cov-2 Infection by Assessing Its Effect on the Proportion of Patients Who Die on Study | Phase 3, Randomized, Placebo-Controlled, Efficacy and Safety Study of VERU-111 for the Treatment of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) in Patients at High Risk for Acute Respiratory Distress Syndrome (ARDS). | VERU-111 | Veru Inc. | 09/04/2021 | 20210409 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04842747 | Recruiting | No | 18 Years | 100 Years | All | May 18, 2021 | 300 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | United States;Argentina;Brazil;Bulgaria;Colombia;Mexico;Argentina;Brazil;Bulgaria;Colombia;Mexico;United States | ; | Barnette;Barnette | | ;veruclinicaltrials@verupharma.com | ;800-606-9382 | Veru Inc.; |
<br> Inclusion Criteria:
<br>
<br> - Provide informed consent from the subject or the subject's Legally Authorized
<br> Representative (LAR)
<br>
<br> - Aged =18 years
<br>
<br> - Severe Acute Respiratory Syndrome Coronavirus (SARS-CoV-2) infection confirmed by
<br> polymerase chain reaction (PCR) test
<br>
<br> - Patients with a WHO Ordinal Scale for Clinical Improvement score of 4 at high risk for
<br> ARDS, must have at least one of the known comorbidities for being at high risk, such
<br> as, Asthma (moderate to severe), Chronic Lung Disease, Diabetes, Hypertension, Severe
<br> Obesity (BMI =40), 65 years of age or older, primarily reside in a nursing home or
<br> long-term care facility, or immunocompromised and patients with a WHO Ordinal Scale
<br> for Clinical Improvement score of 5 or 6 regardless of presence of comorbidities.
<br>
<br> - WHO Ordinal Scale for Clinical Improvement score of 4 (Oxygen by mask or nasal
<br> prongs), 5 (Non-invasive ventilation or high-flow oxygen) or 6 (Intubation and
<br> mechanical ventilation)
<br>
<br> - Peripheral capillary oxygen saturation (SpO2) = 94% on room air at screening. If
<br> patient is on oxygen therapy at the time of presentation for screening and the SpO2
<br> levels were =94% prior to introduction to oxygen therapy with proper documentation
<br> example EMT notes or ER/ED notes, then the patient is considered to have met this
<br> inclusion criterion. If patient is on oxygen therapy at the time of presentation for
<br> screening and the SpO2 levels prior to introduction to oxygen therapy are unknown, the
<br> patient may be considered to have met this inclusion criterion if oxygen therapy is
<br> removed and the SpO2 levels fall to =94%, then the patient is considered to have met
<br> this inclusion criterion. However, removal of the oxygen therapy should only be done
<br> if it is considered medically reasonable
<br>
<br> - Subjects must agree to follow doctor's recommendation for oxygen supplementation
<br>
<br> - Subjects must agree to use acceptable methods of contraception:
<br>
<br> - If female of childbearing potential or a male subject's partner could become
<br> pregnant, use acceptable methods of contraception from the time of the first
<br> administration of study medication until 6months following administration of the
<br> last dose of study medication. Acceptable methods of contraception are as
<br> follows: Condom with spermicidal foam/gel/film/cream/suppository [i.e., barrier
<br> method of contraception], surgical sterilization (vasectomy with documentation of
<br> azospermia) and a barrier method {condom used with spermicidal
<br> foam/gel/film/cream/suppository}, the female partner uses oral contraceptives
<br> (combination estrogen/progesterone pills), injectable progesterone or subdermal
<br> implants and a barrier method (condom used with spermicidal
<br> foam/gel/film/cream/suppository)
<br>
<br> - If the female partner of a male subject has undergone documented tuballigation
<br> (female sterilization), a barrier method (condom used with spermicidal
<br> foam/gel/film/cream/suppository)should also be used
<br>
<br> - If female partner of a male subject has undergone documented placement of an
<br> intrauterine device (IUD) or intrauterine system (IUS),a barrier method (condom
<br> with spermicidal foam/gel/film/cream/suppository)should also be used
<br>
<br> - Subject is willing to comply with the requirements of the protocol through the end of
<br> the study
<br>
<br> Exclusion Criteria:
<br>
<br> - Known hypersensitivity or allergy to colchicine
<br>
<br> - Pregnant or currently breast feeding
<br>
<br> - Participation in any other clinical trial of an experimental treatment for COVID- 19.
<br> Convalescent plasma, dexamethasone and remdesivir are allowed in this study.
<br>
<br> - Concurrent treatment with other experimental agents with actual or possible direct
<br> acting antiviral activity against COVID-19is prohibited <24 hours prior to study drug
<br> dosing(except standard of care). Remdesivir, dexamethasone and convalescent plasma are
<br> allowed in the study.
<br>
<br> - Requiring ventilation + additional organ support - pressors, RRT, ECMO(WHO Ordinal
<br> Scale for Clinical Improvement - Score of 7). NOTE: short term (PRN) use of pressors
<br> is allowed
<br>
<br> - Alanine Aminotransferase (ALT) or aspartate aminotransferase(AST) >3X upper limit of
<br> normal (ULN)
<br>
<br> - Total bilirubin > ULN
<br>
<br> - Creatinine clearance < 60 mL/min
<br>
<br> - Documented medical history of liver disease, including but not limited to, prior
<br> diagnosis of hepatitis of any etiology, cirrhosis, portal hypertension, or confirmed
<br> or suspected esophageal varices
<br>
<br> - Moderate to severe renal impairment
<br>
<br> - Hepatic impairment
<br>
<br> - History of hepatitis - (Hepatitis B and C) NOTE: treated and controlled hepatitis C is
<br> allowed
<br>
<br> - Any comorbid disease or condition (medical or surgical) which might compromise the
<br> hematologic, cardiovascular, endocrine, pulmonary, renal, gastrointestinal, hepatic,
<br> or central nervous system; or other conditions that may interfere with the absorption,
<br> distribution, metabolism or excretion of study drug, or would place the subject at
<br> increased risk
<br>
<br> - Participants must agree to refrain from prolonged exposure to the sun or agree to use
<br> at least SPF 50 on all exposed skin and protective clothing during prolonged sun
<br> exposure throughout participation in this study and/or treatment with VERU-111
<br> | | SARS-CoV Infection | Drug: VERU-111 | VERU-111 in the treatment of SARS-Cov-2 Infection | | | | Yes | False | | |
| → | NCT04843761 | 1 November 2021→15 November 2021 | ACTIV-3b: Therapeutics for Severely Ill Inpatients With COVID-19 | A Multicenter, Adaptive, Randomized, Blinded Controlled Trial of the Safety and Efficacy of Investigational Therapeutics for Hospitalized Patients With Acute Respiratory Distress Syndrome Associated With COVID-19 | TESICO | National Institute of Allergy and Infectious Diseases (NIAID) | 09/04/2021 | 20210409 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04843761 | Recruiting | No | 18 Years | N/A | All | April 20, 2021 | 640 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | United States | ; ; | Samuel Brown, MD;Prof. James Neaton;If interested in participating in this study, please contact the appropriate site or | | ;;tesico@insight-trials.org | ;;send email to | Intermountain Medical Center/University of Utah;INSIGHT Statistical and Coordinating Centre, University of Minnesota; |
<br> Inclusion Criteria:
<br>
<br> - Signed informed consent.
<br>
<br> - Requiring admission to hospital for acute medical care (not for purely public health
<br> or quarantine purposes).
<br>
<br> - Current respiratory failure (i.e. receipt of high-flow nasal cannula, non-invasive
<br> ventilation, invasive mechanical ventilation, or ECMO (extracorporeal membrane
<br> oxygenation) used to treat acute hypoxemic respiratory failure).
<br>
<br> - SARS-CoV-2 (COVID-19) infection, documented by a nucleic acid test (NAT) or equivalent
<br> testing with most recent rest within 14 days prior to randomization.
<br>
<br> - Respiratory failure is believed to be due to SARS-CoV-2 pneumonia.
<br>
<br> Exclusion Criteria:
<br>
<br> - Known allergy to investigational agent or vehicle.
<br>
<br> - More than 4 days since initiation of support for respiratory failure.
<br>
<br> - Chronic/home mechanical ventilation (invasive or non-invasive) for chronic lung or
<br> neuromuscular disease (non-invasive ventilation used solely for sleep-disordered
<br> breathing is not an exclusion).
<br>
<br> - Moribund patient (i.e. not expected to survive 24 hours).
<br>
<br> - Active use of "comfort care" or other hospice-equivalent standard of care.
<br>
<br> - Expected inability to participate in study procedures.
<br>
<br> - In the opinion of the investigator, any condition for which, participation would not
<br> be in the best interest of the participant or that could limit protocol-specified
<br> assessments.
<br>
<br> - Previous enrollment in TESICO
<br>
<br> Agent-specific exclusion criteria
<br>
<br> - Prior receipt of any dose of remdesivir during present illness (remdesivir agent).
<br>
<br> - GFR (glomerular filtration rate) < 30 ml/min and not receiving dialysis (remdesivir
<br> agent).
<br>
<br> - ALT (alanine aminotransferase) or AST (aspartate aminotransferase) > 10 times upper
<br> limit of normal (remdesivir agent).
<br>
<br> - Unwillingness to commit to avoid sex that may result in pregnancy for at least 7 days
<br> after completion of remdesivir vs. placebo (remdesivir agent).
<br>
<br> - Refractory hypotension (aviptadil agent).
<br>
<br> - Severe diarrhea (Aviptadil agent).
<br>
<br> - Current C. difficile infection (aviptadil agent).
<br>
<br> - Pregnancy or current breast-feeding (aviptadil agent).
<br>
<br> - End-stage liver disease (aviptadil agent).
<br> | | Covid19 | Biological: Remdesivir;Drug: Remdesivir Placebo;Biological: Aviptadil;Drug: Aviptadil Placebo;Drug: Corticosteroid | Recovery, assessed at 90 days | | | | Yes | False | | |
| → | NCT04847141 | 10 August 2021→15 November 2021 | A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients | A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of Anti-COVID-19 Immune Globulin (Human) 20% (C19-IG 20%) Versus Placebo in Asymptomatic Ambulatory Outpatients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection | COVID-19 | Grifols Therapeutics LLC | 14/04/2021 | 20210414 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04847141 | Recruiting | No | 18 Years | N/A | All | April 28, 2021 | 801 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | Spain | ; | Oriol Mitjà, MD;Mireia Torres | | ;mireia.torres@grifols.com | ;+34 93 5710500 | omitja@flsida.org, +3493 4978339; |
<br> Inclusion Criteria:
<br>
<br> 1. Ambulatory male or female outpatients = 18 years of age who have laboratory-confirmed
<br> severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined
<br> by qualitative PCR (reverse transcriptase (RT)-PCR), or other commercial or public
<br> health assay approved by regulatory authorities as a diagnostic test for COVID-19
<br> (inclusive of SARS-CoV-2 antigen testing or other approved rapid testing platforms) in
<br> any specimen = 5 days prior to randomized treatment.
<br>
<br> 2. Asymptomatic with no constitutional COVID-19 illness (evident symptoms), specifically
<br> no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache
<br> that is unrelated to pre-existing conditions (example, migraine), sore throat that is
<br> unrelated to other pre-existing medical conditions (example, allergies,
<br> gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with
<br> previous medical condition, or evidence of pneumonia at Screening.
<br>
<br> 3. Pulse oximetry peripheral oxygen saturation (SpO2) (oxygen saturation) on room air >
<br> 94% (i.e., 95% to 100%) at Screening.
<br>
<br> 4. National Early Warning Score (NEWS) = 2 points at Screening.
<br>
<br> 5. Subject provides informed consent (ICF) prior to initiation of any study procedures.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subjects who are admitted to hospital or for whom hospital admission is being planned
<br> at the time of Screening.
<br>
<br> 2. Subjects requiring any form of oxygen supplementation at Screening.
<br>
<br> 3. Concurrent or planned treatment with other agents with actual or possible direct
<br> antiviral activity against SARS-CoV-2 including remdesivir.
<br>
<br> 4. Prior, concurrent or planned treatment with monoclonal antibodies (mAbs) against
<br> SARS-CoV-2
<br>
<br> 5. Have participated in a previous SARS-CoV-2 vaccine study OR outside of a study have
<br> received any SARS-CoV-2 vaccine of any kind.
<br>
<br> 6. Have a history of convalescent COVID-19 plasma treatment at Screening.
<br>
<br> 7. Fever (temperature =38.0° C [=100.4° F]), measured orally, requirement for
<br> antipyretics to reduce temperature (administered for fever), and/or respiratory
<br> symptoms (cough, dyspnea) at Screening.
<br>
<br> 8. Clinical evidence of any significant acute or chronic disease that, in the opinion of
<br> the investigator, may place the subject at undue medical risk for study treatment.
<br>
<br> 9. The subject has had a known (documented) history of serious anaphylactic reaction to
<br> blood, any blood-derived plasma product or commercial immunoglobulin, or has known
<br> selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
<br>
<br> 10. Decompensated congestive heart failure or renal failure with fluid overload. This
<br> includes currently uncontrolled congestive heart failure New York Heart Association
<br> Class III or IV stage heart failure.
<br>
<br> 11. Subjects for whom there is limitation of therapeutic effort such as "Do not
<br> resuscitate" status.
<br>
<br> 12. Currently participating in another interventional clinical trial with investigational
<br> medical product or device.
<br>
<br> 13. Subjects with known (documented) thrombotic complications to polyclonal intravenous
<br> immune globulin (IVIG) therapy in the past.
<br>
<br> 14. Subject has medical condition (other than COVID-19) that is projected to limit
<br> lifespan to = 1 year.
<br>
<br> 15. Subject has history of drug or alcohol abuse within the past 12 months.
<br>
<br> 16. Women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to
<br> practice a highly effective method of contraception (oral, injectable, or implanted
<br> hormonal methods of contraception, placement of an intrauterine device or intrauterine
<br> system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male
<br> sterilization, or true abstinence) throughout the study.
<br> | | COVID-19;Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection | Biological: C19-IG 20%;Drug: 0.9% Sodium chloride | Percentage of Asymptomatic Participants who Remain Asymptomatic, i.e., who do not Develop Symptomatic COVID-19 | | | | Yes | False | | |
| → | NCT04847596 | 4 October 2021→15 November 2021 | A Multicenter Study to Assess Response to COVID-19 Vaccine in Multiple Sclerosis Participants Treated With Ofatumumab | An Open-label Multicenter Single-arm Pilot Study to Assess Immune Response to COVID-19 Vaccine in Participants With Relapsing Multiple Sclerosis Treated With Ofatumumab 20 mg Subcutaneously | | Novartis Pharmaceuticals | 14/04/2021 | 20210414 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04847596 | Recruiting | No | 18 Years | 55 Years | All | May 21, 2021 | 22 | Observational | | | United States→United States;Puerto Rico;United States | ; | Novartis Pharmaceuticals;Novartis Pharmaceuticals | | ;novartis.email@novartis.com | ;1-888-669-6682 | Novartis Pharmaceuticals; |
<br> Inclusion Criteria:
<br>
<br> 1. Signed informed consent must be obtained prior to participation in the study
<br>
<br> 2. Age 18-55 years old inclusive at Screening
<br>
<br> 3. Diagnosis of relapsing MS by 2017 revised McDonald criteria
<br>
<br> 4. Must be willing to comply with the study schedule
<br>
<br> 5. Have received/scheduled vaccination with a FDA approved for emergency use COVID-19
<br> mRNA vaccine (either Pfizer or Moderna) (i) either been scheduled for vaccine, (ii)
<br> received a single vaccine with a scheduled second dose, or (iii) already completed
<br> full course (two dose) vaccination.
<br>
<br> 6. Currently receiving ofatumumab for the treatment of RMS (Preoftumumab serology with
<br> Hepatitis B testing showing no active or latent infection, as well as serum IgG
<br> results to be recorded in the database if available)
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Known clinical diagnosis of COVID-19 prior to screening based on investigator's or
<br> patient's personal physician's judgement
<br>
<br> 2. Has a contraindication to receiving an mRNA COVID-19 vaccine
<br>
<br> 3. Has an immediate allergic reaction to past vaccine or injection
<br>
<br> 4. Any safety finding including low IgG and/or low IgM levels requiring an ofatumumab
<br> treatment interruption within the 12 weeks immediately prior to vaccination as
<br> determined by the HCP
<br>
<br> 5. Any major episode of infection requiring hospitalization or treatment with intravenous
<br> antibiotics within 2 weeks prior to the screening visit
<br>
<br> 6. Prior treatment with S1P agent within 2 months of study enrollment
<br>
<br> 7. Prior treatment with natalizumab within 6 months of study enrollment
<br>
<br> 8. Contraindications to ofatumumab treatment as per the USPI will be adhered to which
<br> include active infection hepatitis B infection, progressive multifocal
<br> leukoencephalopathy and pregnancy.
<br>
<br> 9. Participation in another interventional clinical trial within 14 days before
<br> enrollment.
<br>
<br> 10. Have been treated with any of the medications as described in the full protocol
<br>
<br> 11. Women of child-bearing potential, defined as all women physiologically capable of
<br> becoming pregnant, unless they are using highly effective methods of contraception
<br> while taking study treatment and for 6 months after stopping medication
<br> | | Relapsing Multiple Sclerosis | Other: Ofatumumab;Other: Covid-19 vaccine | Proportion of participants achieving immune response - immune assay No. 1 | | | | Yes | False | | |
| → | NCT04849598 | 26 April 2021→15 November 2021 | Automatic Oxygen Titration in Patients After SARS-CoV-2 Infection | Effects of an Automatic Oxygen Titration vs. Constant Oxygen Flow Rates During Daily Activities in Patients After SARS-CoV-2 Infection | | Schön Klinik Berchtesgadener Land | 13/04/2021 | 20210413 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04849598 | Recruiting→Not recruiting | No | 18 Years | N/A | All | April 13, 2021 | 15 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | N/A | Germany | ; ; → | Andreas R Koczulla, Prof. Dr. med.;Andreas R Koczulla, Prof. Dr. med.;Tessa Schneeberger, MSc→Andreas R Koczulla, Prof. Dr. med. | | ;rkoczulla@schoen-klinik.de;tschneeberger@schoen-klinik.de→ | ;0049-8652-932730;0049 - 8652 - 932730→ | Philipps University Marburg Medical Center;→Philipps University Marburg Medical Center |
<br> Inclusion Criteria:
<br>
<br> - validated COVID19 disease in case history
<br>
<br> - hypoxemia (PO2 < 55 mmHg) under room air conditions (rest or during exercise) or SpO2
<br> <88% during exercise
<br>
<br> - already established Long-term oxygen therapy or given indication for a Long-term
<br> oxygen therapy
<br>
<br> Exclusion Criteria:
<br>
<br> - acute infection
<br>
<br> - cardiovascular diseases that limit physical fitness
<br>
<br> - orthopedic diseases preventing the patient from undergoing the walking tests
<br> | | Post-COVID19 | Other: Oxygen therapy | Change of oxygen saturation during the endurance shuttle walk Tests | | | | Yes | False | | |
| → | NCT04852276 | 1 November 2021→15 November 2021 | Analysis of the Immune Response to COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations | Analysis of the Immune Response to COVID-19 Vaccination and Outcomes in Individuals With and Without Immune Deficiencies and Dysregulations | | National Institute of Allergy and Infectious Diseases (NIAID) | 20/04/2021 | 20210420 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04852276 | Recruiting | No | 3 Years | N/A | All | April 20, 2021 | 600 | Observational | | | United States | ; ; | Emily E Ricotta, Ph.D.;Anita A Ginigeme;For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)→Emily E Ricotta, Ph.D.;Emily E Ricotta, Ph.D.;For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) | | ;NIAIDCovidVaccineStudy@niaid.nih.gov;prpl@cc.nih.gov | ;(240) 328-0643;800-411-1222→;(301) 761-7784;800-411-1222 | National Institute of Allergy and Infectious Diseases (NIAID); |
<br> - INCLUSION CRITERIA:
<br>
<br> In order to be eligible to participate in this study, an individual must meet the following
<br> criteria:
<br>
<br> 1. Aged 12 years and older.
<br>
<br> 2. Must meet the definition of affected participant or control participant:
<br>
<br> 1. Affected participants must have evidence of a primary or secondary immune
<br> deficiency or dysregulation under another NIAID protocol or as documented by an
<br> outside physician.
<br>
<br> 2. Control participants are healthy volunteers that do not have evidence of a
<br> primary or secondary immune deficiency or dysregulation and may include
<br> unaffected relatives of affected participants.
<br>
<br> 3. Ability to provide informed consent.
<br>
<br> 4. Willing to have blood samples stored for future research.
<br>
<br> 5. Able to proficiently speak, read, and write English.
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> Individuals meeting any of the following criteria will be excluded from study
<br> participation:
<br>
<br> 1. Receipt of any other vaccine within 14 days prior to screening.
<br>
<br> 2. Planned non-COVID-19 vaccination within 28 days after COVID-19 vaccination(s).
<br>
<br> 3. Self-reported pregnancy, breast feeding, or intention to initiate a pregnancy before
<br> day 28 after study vaccination.
<br>
<br> 4. Any condition that, in the opinion of the investigator, contraindicates participation
<br> in this study (e.g. specific autoinflammatory diseases, interferonopathies).
<br>
<br> 5. Self-reported history of HIV.
<br> →
<br> - INCLUSION CRITERIA:
<br>
<br> In order to be eligible to participate in this study, an individual must meet the following
<br> criteria:
<br>
<br> 1. Aged 3 years and older.
<br>
<br> 2. Must be eligible to receive (based on official FDA authorization or approval) and
<br> scheduled to receive or have already received a COVID-19 vaccine outside of this
<br> facility.
<br>
<br> 3. Must meet the definition of affected participant or control participant:
<br>
<br> 1. Affected participants must have evidence of a primary or secondary immune
<br> deficiency or dysregulation under another NIAID protocol or as documented by an
<br> outside physician.
<br>
<br> 2. Control participants are healthy volunteers that do not have evidence of a
<br> primary or secondary immune deficiency or dysregulation and may include
<br> unaffected relatives of affected participants.
<br>
<br> 4. Ability to provide informed consent.
<br>
<br> 5. Willing to have blood samples stored for future research.
<br>
<br> 6. Able to proficiently speak, read, and write English.
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> Individuals meeting any of the following criteria will be excluded from study
<br> participation:
<br>
<br> 1. Receipt of any other vaccine within 14 days prior to screening.
<br>
<br> 2. Planned non-COVID-19 vaccination within 28 days after COVID-19 vaccination(s).
<br>
<br> 3. Any condition that, in the opinion of the investigator, contraindicates participation
<br> in this study (e.g. specific autoinflammatory diseases, interferonopathies).
<br>
<br> 4. Self-reported history of HIV.
<br> | | Immunodeficiencies;Immune Dysregulations | | Change in S and RBD immunoglobulin G (IgG) antibody titer from baseline depending on vaccine manufacturer and platform | | | | Yes | False | | |
| → | NCT04852289 | 1 November 2021→15 November 2021 | A Clinical Observational Study of SARS-CoV-2 Specific CD8 T-Cell Responses to COVID-19 Vaccines in Humans | A Clinical Observational Study of SARS-CoV-2 Specific CD8 T-Cell Responses to COVID-19 Vaccines in Humans | | National Institute on Aging (NIA) | 20/04/2021 | 20210420 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04852289 | Recruiting | No | 18 Years | N/A | All | November 3, 2021→November 18, 2021 | 160 | Observational | | | United States | ; ; | Nan-Ping Weng, M.D.;Julia L McKelvey, R.N.;NIA Studies Recruitment | | ;mckelveyju@nih.gov;niastudiesrecruitment@mail.nih.gov | ;(410) 350-3929;410-350-3941 | National Institute on Aging (NIA); |
<br> - INCLUSION CRITERIA:
<br>
<br> In order to be eligible to participate in this study, an individual must meet all of the
<br> following criteria:
<br>
<br> 1. Ability of subject to understand the study and stated willingness to comply with all
<br> study procedures and availability for the duration of the study.
<br>
<br> 2. Male or female, aged 18 years or older.
<br>
<br> 3. Willingness and ability to come to the NIH/National Institute on Aging Clinical
<br> Research Unit at MedStar Harbor Hospital or the NIH/NIA/Biomedical Research Center at
<br> Johns Hopkins Bayview campus in Baltimore for study procedures.
<br>
<br> 4. Laboratory-confirmed negative tests for SARS-CoV-2 infection as determined by both of
<br> the following: Nasal turbinate swab (PCR) and Qualitative IgG Serology antibody
<br> testing.
<br>
<br> EXCLUSION CRITERIA
<br>
<br> An individual who meets any of the following criteria will be excluded from participation
<br> in this study:
<br>
<br> 1. Unable to provide informed consent.
<br>
<br> 2. Current use of steroids, immunosuppressive medications, radiation therapy, or
<br> chemotherapy medications.
<br>
<br> 3. Pregnancy
<br>
<br> 4. Received immunization therapy for COVID-19 prior to visit 1.
<br>
<br> In addition, eligible participants may not be immediately able to participate in the study
<br> but might be eligible at a later date. These include:
<br>
<br> 1. Symptoms of a viral infection on visit 1 (defer until resolved).
<br>
<br> 2. Medication: Volunteers taking the following medications would be deferred for 2 weeks
<br> after course has been completed and volunteer is feeling well: Antibiotics,
<br> antifungals, antimalarials.
<br>
<br> 3. Temporary steroids (tapers): Deferred for 72 hours after symptoms are resolved and
<br> prescription is completed if taken orally, intravenously, or intramuscular. No
<br> deferral if taken intranasal, inhaled, or for joint injection.
<br>
<br> 4. Infection or Fever: Deferred until 2 weeks after antibiotics are completed and /or
<br> volunteer is feeling well.
<br>
<br> 5. We wish to only select healthy confirmed COVID-19 negative patients. Therefore, those
<br> who may have a household member (co-habitant) who is newly diagnosed with COVID-19 or
<br> who has symptoms will be deferred for 14 days.
<br>
<br> 6. Treatment with another investigational drug or other intervention within 14 days of
<br> visit 1 per the discretion of the Principal Investigator.
<br> | | COVID-19 | | We are investigating the presence or absence of various SARS-CoV-2 specific CD8 T cells in healthy COVID-19 vaccinated participants to understand the composition of CD8 T cell immunity in COVID-19 pathogenesis. | | | | Yes | False | | |
| → | NCT04852822 | 1 November 2021→15 November 2021 | Immune Response to SARS-CoV-2 (COVID-19) Vaccines in Patients With Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | Multicenter Evaluation of SARS-CoV-2 Vaccines in Patients With CLL/SLL | | University of Washington | 19/04/2021 | 20210419 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04852822 | Recruiting | No | 18 Years | N/A | All | March 18, 2021 | 500 | Observational | | | United States | ; | Chaitra S. Ujjani, MD;Amy Sperling | | ;sperla2@seattlecca.org | ;206-606-1386 | Fred Hutch/University of Washington Cancer Consortium; |
<br> Inclusion Criteria:
<br>
<br> - Age >= 18 years
<br>
<br> - A diagnosis of chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL)
<br>
<br> - Willing and able to participate in all required evaluations and procedures in this
<br> study
<br>
<br> Exclusion Criteria:
<br>
<br> - Any evidence of prior SARS-CoV-2/COVID19 infection
<br> | | Chronic Lymphocytic Leukemia;Small Lymphocytic Lymphoma | Procedure: Biospecimen Collection;Other: Electronic Health Record Review | Response rate to the SARS-CoV-2 vaccine among patients with chronic lymphocytic leukemia/small lymphocytic lymphoma | | | | Yes | False | | |
| → | NCT04855162 | 2 August 2021→15 November 2021 | Use of Lung Ultrasound in Evaluating Physiological Response to Awake Self Proning | Use of Lung Ultrasound in Evaluating Physiological Response to Awake Self Proning | | Rush University Medical Center | 13/04/2021 | 20210413 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04855162 | Recruiting→Not recruiting | No | 18 Years | N/A | All | July 21, 2021 | 35→74 | Observational | | | United States;Mexico;United States | ; → | Jie Li;Jie Li→Jie Li | | ;Jie_Li@rush.edu→ | ;(312) 563-4643→ | Rush University;→Rush University |
<br> Inclusion Criteria:
<br>
<br> 1. Adult subjects 18 years and older,
<br>
<br> 2. Confirmed COVID-19 diagnosis
<br>
<br> 3. Acute hypoxemic respiratory failure (SpO2/FiO2 or PaO2/FiO2 <300)
<br>
<br> 4. Ordered self-prone positioning per medical team
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnant
<br>
<br> 2. Palliative care
<br> | | Covid19 | | SpO2/FiO2 pre prone in day 1;SpO2/FiO2 post prone in day 1;SpO2/FiO2 pre prone in day 2;SpO2/FiO2 post prone in day 2;SpO2/FiO2 pre prone in day 3;SpO2/FiO2 post prone in day 3;Lung Ultrasound Score pre prone in day 1;Lung Ultrasound Score post prone in day 1;Lung Ultrasound Score pre prone in day 2;Lung Ultrasound Score post prone in day 2;Lung Ultrasound Score pre prone in day 3;Lung Ultrasound Score post prone in day 3→SpO2/FiO2 pre prone in day 1;Lung Ultrasound Score post prone in day 3;Lung Ultrasound Score pre prone in day 3;Lung Ultrasound Score post prone in day 2;Lung Ultrasound Score pre prone in day 2;Lung Ultrasound Score post prone in day 1;Lung Ultrasound Score pre prone in day 1;SpO2/FiO2 post prone in day 3;SpO2/FiO2 pre prone in day 3;SpO2/FiO2 post prone in day 2;SpO2/FiO2 pre prone in day 2;SpO2/FiO2 post prone in day 1 | | | | Yes | False | | |
| → | NCT04860518 | 11 October 2021→15 November 2021 | Human Intravenous Interferon Beta-Ia Safety and Preliminary Efficacy in Hospitalized Subjects With CoronavirUS | A Phase II Multi-Center, Double-Blind, Randomized and Controlled Study of the Safety and Efficacy of Intravenous Recombinant Human Interferon Beta-1a in Comparison to Dexamethasone for the Treatment of Hospitalized Patients With COVID-19 Infection | HIBISCUS | Faron Pharmaceuticals Ltd | 22/04/2021 | 20210422 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04860518 | Recruiting | No | 18 Years | N/A | All | August 23, 2021 | 140 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | United States | ; ; | Daniel Talmor, MD MPH,;Adit Ginde, MD MPH,;Matti Karvonen, MD, PhD→Daniel Talmor, MD MPH,;Adit Ginde, MD MPH,;Jarna Hannukainen, PhD | | ;;matti.karvonen@faron.com→;;jarna.hannukainen@faron.com | ;;+358 02 469 5151 | Deaconess Medical Center, Spokane, Washington;University of Colorado School of Medicine; |
<br> Inclusion Criteria:
<br>
<br> 1. Age =18 years
<br>
<br> 2. Positive SARS-CoV-2 test by PCR (polymerase chain reaction) or other diagnostic method
<br> within the past 7 days
<br>
<br> 3. Admission to hospital with respiratory symptoms of COVID-19 requiring hospital care
<br> and oxygen supplementation (= 8L/min)
<br>
<br> 4. Symptom onset no more than 7 days prior to hospital arrival
<br>
<br> 5. Informed consent from the subject or the subject's personal legal representative or a
<br> professional legal representative must be available
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Unable to screen, randomize and administer study drug within 48 hours from arrival to
<br> hospital
<br>
<br> 2. Systemic corticosteroid or baricitinib therapy within 7 days prior to arrival to
<br> hospital or planned for the next days
<br>
<br> 3. Known hypersensitivity or contraindication to natural or recombinant IFN-beta-1a or
<br> its excipients, or to dexamethasone or its excipients
<br>
<br> 4. Currently receiving IFN-beta-1a therapy
<br>
<br> 5. Home assisted ventilation (via tracheotomy or non-invasive) except for Continuous
<br> Positive Airway Pressure (CPAP) / Bilevel Positive Airway Pressure (BIPAP) used only
<br> for sleep-disordered breathing
<br>
<br> 6. Participation in another concurrent interventional pharmacotherapy trial during the
<br> study period
<br>
<br> 7. Decision to withhold life-sustaining treatment; patient not committed to full support
<br> (except DNR after cardiac arrest only)
<br>
<br> 8. Woman known to be pregnant, lactating or with a positive pregnancy test (urine or
<br> serum test)
<br>
<br> 9. Subject is not expected to survive for 24 hours
<br>
<br> 10. Subject has liver failure (Child-Pugh grade C)
<br>
<br> 11. Any clinical condition that in the opinion of the attending clinician or Investigator
<br> would present a risk for the subject to participate in the study
<br> | | Covid19 | Drug: IFN beta-1a;Drug: Dexamethasone | Clinical status at Day 14 (first day of study drug is Day 1) as measured by WHO 9-point ordinal scale | | | | Yes | False | | |
| → | NCT04864548 | 27 September 2021→15 November 2021 | COV-CHIM01: SARS-CoV-2 (COVID-19) Dose Finding Infection Study | A Dose Finding Human Experimental Infection Study With SARS-CoV-2 in Healthy Volunteers With Previous, Microbiologically Confirmed, SARS-CoV-2 Infection | | University of Oxford | 20/04/2021 | 20210420 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04864548 | Recruiting | No | 18 Years | 30 Years | All | May 27, 2021 | 64 | Interventional | Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Other. Masking: None (Open Label). | Phase 1 | United Kingdom | ; | Helen McShane, MD and PhD;Volunteer Recruitment Co-ordinator | | ;Covid19-challenge@paediatrics.ox.ac.uk | ;07990431010 | University of Oxford; |
<br> Inclusion Criteria:
<br>
<br> 1. Seropositive to the challenge virus SARS-CoV-2 (Anti-Spike IgG or Anti-nucleocapsid
<br> IgG) at screening with previous microbiological confirmation of SARS-CoV-2 infection >
<br> 3 months prior to enrolment (confirmed via medical notes/ or PHE).
<br>
<br> 2. Aged 18-30 years on proposed date of enrolment.
<br>
<br> 3. Body Mass Index (BMI) =18.5 kg/m2and =28 kg/m2.
<br>
<br> 4. In good health with no history of clinically significant medical conditions (as
<br> described in Exclusion criteria) that would interfere with subject safety, as defined
<br> by medical history, physical examination, routine laboratory tests, cardiovascular
<br> magnetic resonance imaging or echocardiogram, ECG, pulmonary function tests and Chest
<br> X-Ray as determined by the Investigator at a screening evaluation.
<br>
<br> 5. Volunteer is willing and able to give written informed consent for participation in
<br> the study
<br>
<br> 6. Willing to allow the investigators to discuss the volunteer's medical history with
<br> their General Practitioner or any relevant health authority
<br>
<br> 7. Allow the investigator to register volunteer details with a confidential database (The
<br> Over-volunteering Prevention Service) to prevent concurrent entry into clinical
<br> studies/trials
<br>
<br> 8. Agreement to refrain from blood donation during the course of the study
<br>
<br> 9. a. For women of child bearing potential (WOCBP), a willingness to practice continuous
<br> effective contraception during the study and, a negative pregnancy test on the day(s)
<br> of screening and challenge b. For men, a willingness to practice continuous effective
<br> contraception (see below) from day of challenge to 6 months post treatment with
<br> Regeneron
<br>
<br> 10. Able and willing (in the investigator's opinion) to comply with all study requirements
<br>
<br> 11. No clinically relevant findings in medical history or on physical examination
<br>
<br> Exclusion Criteria:
<br>
<br> 1) History or evidence of any clinically significant or currently active cardiovascular,
<br> (including thromboembolic events), respiratory (excluding SARS CoV-2 infection),
<br> dermatological, gastrointestinal, endocrine, haematological, hepatic, immunological,
<br> rheumatological, metabolic, urological, renal, neurological or psychiatric illness.
<br> Specifically:
<br>
<br> 1. Volunteers with any history of physician diagnosed and/or objective test confirmed
<br> asthma, chronic obstructive pulmonary disease, pulmonary hypertension, reactive airway
<br> disease, or chronic lung condition of any aetiology or who have experienced:
<br>
<br> i) Significant/severe wheeze in the past ii) Respiratory symptoms including wheeze
<br> which has ever resulted in hospitalisation iii) Known bronchial hyper reactivity to
<br> viruses
<br>
<br> 2. History of thromboembolic, cardiovascular or cerebrovascular disease
<br>
<br> 3. History or evidence of diabetes mellitus (Type I or Type II)
<br>
<br> 4. Any concurrent serious illness including history of malignancy that could interfere
<br> with the aims of the study or a subject completing the study. Basal cell carcinoma
<br> within 5 years of treatment or with evidence of recurrence is also an exclusion.
<br>
<br> 5. Migraine with associated neurological symptoms such as hemiplegia or vision loss.
<br> Cluster headache/migraine or prophylactic treatment for migraine
<br>
<br> 6. History or evidence of autoimmune disease or known immunodeficiency of any cause
<br> (including HIV).
<br>
<br> 7. Psychiatric illness including volunteers with a history of depression and/or anxiety
<br> with associated severe psychiatric comorbidities, for example psychosis. Specifically,
<br> i) Volunteers with history of anxiety-related symptoms of any severity within the last
<br> 2 years if the Generalized Anxiety Disorder-7 score is =5 ii) Volunteers with a
<br> history of depression of any severity within the last 2 years if the Patient Health
<br> Questionnaire-9 score is =4 iii) Significant claustrophobia
<br>
<br> 8. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or
<br> prior history of significant bleeding or bruising following injections or
<br> venepuncture.
<br>
<br> 9. Other major disease that, in the opinion of the Investigator, could interfere with a
<br> subject completing the study and necessary investigations.
<br>
<br> 2) Clinically significant smoking history. Defined as: Current smoker (any smoking
<br> including e-cigarettes in the last 3 months) or > 2 pack year smoking history at any time
<br> (2 pack years is equivalent to 20 cigarettes daily for 2 years), or use of any nicotine
<br> containing products within the last 3 months.
<br>
<br> 3) History or presence of alcohol addiction, or excessive use of alcohol (average weekly
<br> intake in excess of 28 units alcohol; one unit being a half glass of beer, a small glass of
<br> wine or a measure of spirits)
<br>
<br> 4) History of use of drugs of misuse, with evidence of a negative drugs of misuse urine
<br> test required at screening and quarantine admission
<br>
<br> 5) History of anaphylaxis or any allergy likely to be worsened by any component of the
<br> study agent or proposed treatment regime.
<br>
<br> 6) Clinically active rhinitis (including hay fever) or history of moderate to severe
<br> rhinitis, or history of seasonal allergic rhinitis likely to be active at time of inclusion
<br> into the study and/or requiring regular nasal corticosteroids on at least weekly basis,
<br> within 30 days of admission to quarantine.
<br>
<br> 7) Any significant abnormality altering the anatomy of the nose or nasopharynx, clinically
<br> significant history of epistaxis (nose bleeds) or any nasal or sinus surgery within six
<br> months of inoculation
<br>
<br> 8) Clinical, radiological, or laboratory evidence of current active TB disease or latent TB
<br> infection
<br>
<br> 9) Previous VZV pneumonia
<br>
<br> 10) Positive HBsAg, HCV or HIV antibodies
<br>
<br> 11) Concurrent use of oral, inhaled or systemic steroid medication or use within the last 6
<br> months (steroids used as a cream or ointment are permissible), or the use of other
<br> immunosuppressive agents concurrently or within the last 6 months.
<br>
<br> 12) Administration of immunoglobulins and/or any blood products within the three months
<br> preceding the planned study challenge date
<br>
<br> 13) Current use of any medication or other drug taken through the nasal or inhaled route
<br> including cocaine or other recreational drugs
<br>
<br> 14) Plans to receive a live vaccination 30 days prior to enrolment, or any vaccination
<br> (i.e. non-live, including a SARS-CoV-2 vaccine) 21 days prior to enrolment and/or plans to
<br> take any vaccination 30 days following enrolment
<br>
<br> 15) Current pregnancy or pregnancy within the last 6 months, lactation or intention to
<br> become pregnant during study period
<br>
<br> 16) Shares a household/ is in a support bubble with someone with clinically significant
<br> immunodeficiency (due to underlying med→
<br> Inclusion Criteria:
<br>
<br> 1. Seropositive to the challenge virus SARS-CoV-2 (Anti-Spike IgG or Anti-nucleocapsid
<br> IgG) at screening with previous microbiological confirmation of SARS-CoV-2 infection >
<br> 3 months prior to enrolment (confirmed via medical notes/ or PHE).
<br>
<br> 2. Aged 18-30 years on proposed date of enrolment.
<br>
<br> 3. Body Mass Index (BMI) =18.5 kg/m2and =28 kg/m2.
<br>
<br> 4. In good health with no history of clinically significant medical conditions (as
<br> described in Exclusion criteria) that would interfere with subject safety, as defined
<br> by medical history, physical examination, routine laboratory tests, cardiovascular
<br> magnetic resonance imaging or echocardiogram, ECG, pulmonary function tests and Chest
<br> X-Ray as determined by the Investigator at a screening evaluation.
<br>
<br> 5. Volunteer is willing and able to give written informed consent for participation in
<br> the study
<br>
<br> 6. Willing to allow the investigators to discuss the volunteer's medical history with
<br> their General Practitioner or any relevant health authority
<br>
<br> 7. Allow the investigator to register volunteer details with a confidential database (The
<br> Over-volunteering Prevention Service) to prevent concurrent entry into clinical
<br> studies/trials
<br>
<br> 8. Agreement to refrain from blood donation during the course of the study
<br>
<br> 9. a. For women of child bearing potential (WOCBP), a willingness to practice continuous
<br> effective contraception during the study and, a negative pregnancy test on the day(s)
<br> of screening and challenge b. For men, a willingness to practice continuous effective
<br> contraception (see below) from day of challenge to 6 months post treatment with
<br> Regeneron
<br>
<br> 10. Able and willing (in the investigator's opinion) to comply with all study requirements
<br>
<br> 11. No clinically relevant findings in medical history or on physical examination
<br>
<br> Exclusion Criteria:
<br>
<br> 1) History or evidence of any clinically significant or currently active cardiovascular,
<br> (including thromboembolic events), respiratory (excluding SARS CoV-2 infection),
<br> dermatological, gastrointestinal, endocrine, haematological, hepatic, immunological,
<br> rheumatological, metabolic, urological, renal, neurological or psychiatric illness.
<br> Specifically:
<br>
<br> 1. Volunteers with any history of physician diagnosed and/or objective test confirmed
<br> asthma, chronic obstructive pulmonary disease, pulmonary hypertension, reactive airway
<br> disease, or chronic lung condition of any aetiology or who have experienced:
<br>
<br> i) Significant/severe wheeze in the past ii) Respiratory symptoms including wheeze
<br> which has ever resulted in hospitalisation iii) Known bronchial hyper reactivity to
<br> viruses
<br>
<br> 2. History of thromboembolic, cardiovascular or cerebrovascular disease
<br>
<br> 3. History or evidence of diabetes mellitus (Type I or Type II)
<br>
<br> 4. Any concurrent serious illness including history of malignancy that could interfere
<br> with the aims of the study or a subject completing the study. Basal cell carcinoma
<br> within 5 years of treatment or with evidence of recurrence is also an exclusion.
<br>
<br> 5. Migraine with associated neurological symptoms such as hemiplegia or vision loss.
<br> Cluster headache/migraine or prophylactic treatment for migraine
<br>
<br> 6. History or evidence of autoimmune disease or known immunodeficiency of any cause
<br> (including HIV).
<br>
<br> 7. Psychiatric illness including volunteers with a history of depression and/or anxiety
<br> with associated severe psychiatric comorbidities, for example psychosis. Specifically,
<br> i) Volunteers with history of anxiety-related symptoms of any severity within the last
<br> 2 years if the Generalized Anxiety Disorder-7 score is =5 ii) Volunteers with a
<br> history of depression of any severity within the last 2 years if the Patient Health
<br> Questionnaire-9 score is =4 iii) Significant claustrophobia
<br>
<br> 8. Bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or
<br> prior history of significant bleeding or bruising following injections or
<br> venepuncture.
<br>
<br> 9. Other major disease that, in the opinion of the Investigator, could interfere with a
<br> subject completing the study and necessary investigations.
<br>
<br> 2) Clinically significant smoking history. Defined as: Current smoker (any smoking
<br> including e-cigarettes in the last 3 months) or > 2 pack year smoking history at any time
<br> (2 pack years is equivalent to 20 cigarettes daily for 2 years), or use of any nicotine
<br> containing products within the last 3 months.
<br>
<br> 3) History or presence of alcohol addiction, or excessive use of alcohol (average weekly
<br> intake in excess of 28 units alcohol; one unit being a half glass of beer, a small glass of
<br> wine or a measure of spirits)
<br>
<br> 4) Clinically significant history of use of drugs of misuse, with evidence of a negative
<br> drugs of misuse urine test required at screening and quarantine admission
<br>
<br> 5) History of anaphylaxis or any allergy likely to be worsened by any component of the
<br> study agent or proposed treatment regime.
<br>
<br> 6) Clinically active rhinitis (including hay fever) or history of moderate to severe
<br> rhinitis, or history of seasonal allergic rhinitis likely to be active at time of inclusion
<br> into the study and/or requiring regular nasal corticosteroids on at least weekly basis,
<br> within 30 days of admission to quarantine.
<br>
<br> 7) Any significant abnormality altering the anatomy of the nose or nasopharynx, clinically
<br> significant history of epistaxis (nose bleeds) or any nasal or sinus surgery within six
<br> months of inoculation
<br>
<br> 8) Clinical, radiological, or laboratory evidence of current active TB disease or latent TB
<br> infection
<br>
<br> 9) Previous VZV pneumonia
<br>
<br> 10) Positive HBsAg, HCV or HIV antibodies
<br>
<br> 11) Concurrent use of oral, inhaled or systemic steroid medication or use within the last 6
<br> months (steroids used as a cream or ointment are permissible), or the use of other
<br> immunosuppressive agents concurrently or within the last 6 months.
<br>
<br> 12) Administration of immunoglobulins and/or any blood products within the three months
<br> preceding the planned study challenge date
<br>
<br> 13) Current use of any medication or other drug taken through the nasal or inhaled route
<br> including cocaine or other recreational drugs
<br>
<br> 14) Plans to receive a live vaccination 30 days prior to enrolment, or any vaccination
<br> (i.e. non-live, including a SARS-CoV-2 vaccine) 21 days prior to enrolment and/or plans to
<br> take any vaccination 30 days following enrolment
<br>
<br> 15) Current pregnancy or pregnancy within the last 6 months, lactation or intention to
<br> become pregnant during study period
<br>
<br> 16) Shares a household/ is in a support bubble with someone with clinically significant
<br> immunodeficiency | | Coronavirus | Biological: SARS-CoV-2 virus | Selection of optimal dose;Occurrence of adverse events as determined by medical assessment;Occurrence of solicited and unsolicited adverse events | | | | Yes | False | | |
| → | NCT04880642 | 1 November 2021→15 November 2021 | A Trial to Investigate Recovery From COVID-19 With C21 in Adult Subjects | A Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3, Multicenter Trial Investigating the Efficacy and Safety of C21 as Add on to Standard of Care in Adult Subjects With COVID-19. | ATTRACT-3 | Vicore Pharma AB | 28/04/2021 | 20210428 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04880642 | Recruiting | No | 18 Years | N/A | All | September 16, 2021 | 600 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States;Argentina;Brazil;Colombia;Czechia;Peru;Philippines;Ukraine;Argentina;Brazil;Colombia;Czechia;Peru;Philippines;Ukraine;United States→United States;Ukraine;Philippines;Peru;India;Czechia;Colombia;Brazil;Argentina;Ukraine;Philippines;Peru;India;Czechia;Colombia;Brazil;Argentina;United States | ; | Anne-Katrine Cohrt, M.Sc.;Maureen Horton, Prof. | | info@vicorepharma.com; | +46 (0) 317880560; | |
<br> Inclusion Criteria:
<br>
<br> 1. Age =18 years or the legal age of consent in the jurisdiction in which the trial is
<br> taking place at the time of signing the informed consent
<br>
<br> 2. Hospitalized due to Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2)
<br> infection confirmed by polymerase chain reaction test, documented by either of the
<br> following:
<br>
<br> 1. Polymerase chain reaction (PCR) positive in sample collected <72 hours prior to
<br> randomization (Visit 2); OR
<br>
<br> 2. PCR positive in sample collected =72 hours and =7 days prior to randomization,
<br> documented inability to obtain a repeat sample AND progressive disease suggestive
<br> of ongoing SARS-CoV-2 infection
<br>
<br> 3. A score of 5 or 6 on the 8-point ordinal scale:
<br>
<br> 1. Score 5: Hospitalized, requiring supplemental oxygen
<br>
<br> 2. Score 6: Hospitalized, on non-invasive ventilation or high-flow oxygen device
<br>
<br> 4. Contraceptive use by men and women of childbearing potential consistent with local
<br> regulations regarding the methods of contraception for those participating in clinical
<br> studies
<br>
<br> 5. Written informed consent, consistent with International Council for Harmonization Good
<br> Clinical Practice Revision 2 and local laws, obtained before the initiation of any
<br> trial- related procedure
<br>
<br> 6. Capable of giving signed informed consent which includes compliance with the
<br> requirements and restrictions listed in the informed consent form and in this protocol
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Concurrent serious medical condition which in the opinion of the investigator
<br> constitutes a risk or a contraindication for the participation in the trial or that
<br> could interfere with the trial objectives, conduct or evaluation
<br>
<br> 2. Known, active hepatitis B, C, or human immunodeficiency virus infection (i.e., human
<br> immunodeficiency virus (HIV) with a cluster of differentiation 4 (CD4) count <500
<br> cells/mm³)
<br>
<br> 3. Impaired hepatic function (i.e., Child-Pugh class A or B)
<br>
<br> 4. Severe renal impairment (i.e., estimated glomerular filtration rate (eGFR) =30
<br> ml/min/1.73 m2)
<br>
<br> 5. Corona virus disease (COVID)-19 symptom onset >14 days prior to screening
<br>
<br> 6. Hospitalized due to COVID-19 for >72 hours at screening
<br>
<br> 7. Invasive mechanical ventilation or ECMO within 72 hours of screening
<br>
<br> 8. Expected need for invasive mechanical ventilation or ECMO in <48 hours in the opinion
<br> of the investigator
<br>
<br> 9. Moderate to severe ARDS (e.g., partial pressure of oxygen (PaO2)/FiO2 =200 mmHg), if
<br> on non-invasive mechanical ventilation or high-flow oxygen
<br>
<br> 10. Pregnant or breast-feeding female subjects
<br>
<br> 11. Any previous and concurrent experimental treatment for COVID-19 that is not considered
<br> local SoC.
<br>
<br> 12. Treatment with the medications listed below within 1 week prior to screening or
<br> anticipated need for such medication during the participation in this trial:
<br>
<br> 1. Strong Cytochrome P450 (CYP) 3A4 inducers.
<br>
<br> 2. P-glycoprotein (P-gp) substrates with narrow therapeutic index.
<br>
<br> 3. High dose Breast Cancer Resistance Protein (BCRP) sensitive substrates.
<br>
<br> 4. Warfarin.
<br>
<br> 5. Sulphasalazine or rosuvastatin.
<br>
<br> 13. Current or previous participation in any other clinical trial where the subject has
<br> received a dose of IMP within 1 month or 5 half-lives of the investigational medicinal
<br> product (IMP), whichever is longest, prior to screening
<br>
<br> 14. Positive pregnancy test
<br>
<br> 15. Abnormal laboratory value at screening indicating a potential risk for the subject if
<br> enrolled in the trial as evaluated by the investigator
<br> | | Covid19 | Drug: C21;Drug: Placebo | Proportion of subjects discharged from hospital and free of supplemental oxygen | | | | Yes | False | | |
| → | NCT04884295 | 17 August 2021→15 November 2021 | Dose-Finding, Safety, and Efficacy Study of XVR011 Added to Standard of Care in Patients Hospitalised for COVID-19 | A 2-part Clinical Study Including a First in Human, Open Label, Single Ascending Dose Part (Phase 1) Followed by a Randomised, Double Blind, Placebo-controlled Part (Phase 2) to Evaluate the Efficacy and Safety of XVR011 in Patients Hospitalised for Mild to Moderate Coronavirus Disease 2019 (COVID-19) | | ExeVir Bio BV | 06/05/2021 | 20210506 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04884295 | Recruiting | Yes | 18 Years | N/A | All | August 2021→August 26, 2021 | 279 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | Belgium;Italy;Belgium;Italy | | Study Inquiry | | exevir0101@exevir.com | +32 2 899 87 37 | |
<br> Inclusion Criteria:
<br>
<br> - Is = 18 years of age
<br>
<br> - Tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by
<br> RT-PCR and/or antigen test.
<br>
<br> - Had an onset of COVID-19 symptom(s) within 7 days prior to screening.
<br>
<br> - Requires hospitalisation for medical care of mild to moderate symptoms and has oxygen
<br> saturation > 93%
<br>
<br> Exclusion Criteria:
<br>
<br> - Requires non-invasive or invasive mechanical ventilation and/or intensive care.
<br>
<br> - Symptoms consistent with severe COVID-19
<br>
<br> - Has received a SARS-CoV-2 vaccine, monoclonal antibody, plasma from a person who
<br> recovered from COVID-19 or any investigational treatment for COVID-19 within 30 days
<br> prior to study treatment.
<br>
<br> NOTE: Other protocol defined inclusion/exclusion criteria apply
<br> →
<br> Inclusion Criteria:
<br>
<br> - Is = 18 years of age.
<br>
<br> - Tested positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by
<br> RT-PCR and/or antigen test.
<br>
<br> - Had an onset of COVID-19 symptom(s) within 8 days prior to screening; except for
<br> dyspnoea and/or tachypnoea for which an onset within 2 days prior to screening is
<br> applicable.
<br>
<br> - Requires hospitalisation for medical care.
<br>
<br> - Has oxygen saturation >= 91%.
<br>
<br> Exclusion Criteria:
<br>
<br> - Requires non-invasive or invasive mechanical ventilation and/or intensive care.
<br>
<br> - Symptoms consistent with severe COVID-19.
<br>
<br> - Has received a monoclonal antibody, plasma from a person who recovered from COVID-19
<br> or any investigational treatment for COVID-19 within 30 days prior to study treatment.
<br>
<br> - Has received an investigational or approved vaccination against SARS-CoV-2 within 14
<br> days prior to study treatment.
<br>
<br> NOTE: Other protocol defined inclusion/exclusion criteria apply
<br> | | Covid19 | Drug: XVR011;Drug: Normal saline | Time to recovery (i.e., clinical status reaching level 1 to 3 of the 8-point ordinal scale);Proportion of subjects with Adverse Events (all and serious) | | | | Yes | True | child | |
| → | NCT04888793 | 7 June 2021→15 November 2021 | Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study | Immune Response to Anti COVID-19 Vaccine in Immunocompromised Patients: a Cohort Study | | Pontificia Universidad Catolica de Chile | 09/05/2021 | 20210509 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04888793 | Recruiting | No | 18 Years | N/A | All | May 12, 2021 | 516 | Observational | | | Chile | ; ; | Elvira Balcells, MD;Elvira Balcells, MD;Elvira Balcells, MD | | ;ebalcells@uc.cl;ebalcells@uc.cl | ;56223543508; | Pontificia Universidad Catolica de Chile; |
<br> General Inclusion Criteria:
<br>
<br> - Eastern Cooperative Oncology Group < 3
<br>
<br> - Vaccination with 2 doses of Coronavac vaccine
<br>
<br> General Exclusion Criteria:
<br>
<br> - Previous SARS-CoV-2 infection
<br>
<br> - Vaccination with Coronavac more than 10 weeks before informed consent
<br>
<br> - Intravenous immunoglobulin therapy 60 days before informed consent
<br>
<br> - Any condition, that could interfere with the participant's participation during the
<br> study in the opinion of the treating investigator.
<br>
<br> Cancer Cohort
<br>
<br> Inclusion Criteria:
<br>
<br> - Diagnosis of cancer in the previous 5 years (consistent biopsy is required).
<br>
<br> - Life expectancy more than 12 weeks
<br>
<br> Exclusion Criteria:
<br>
<br> - Bone marrow transplant, solid organ recipient, HIV, immunosuppressant treatment for
<br> other condition.
<br>
<br> Bone Marrow Transplant Cohort
<br>
<br> Inclusion Criteria:
<br>
<br> - Bone marrow transplant between January 2019 and December 2020
<br>
<br> Exclusion Criteria:
<br>
<br> - Other cancer diagnosis during the last 5 years, solid organ recipient, HIV,
<br> immunosuppressant treatment for other condition.
<br>
<br> Solid Organ Recipient Cohort:
<br>
<br> Inclusion Criteria:
<br>
<br> - Liver, kidney or heart transplant between January 2019 and December 2020
<br>
<br> - Active immunosuppressant treatment
<br>
<br> Exclusion Criteria:
<br>
<br> - Cancer diagnosis during the last 5 years, bone marrow transplant, immunosuppressant
<br> treatment for other condition, HIV
<br>
<br> HIV Cohort:
<br>
<br> Inclusion Criteria:
<br>
<br> - CD4 <= 500 cels/mm3 documented one year before study enrollment
<br>
<br> - Active antiretroviral therapy
<br>
<br> - Viral load < 200 copies/ml
<br>
<br> Exclusion Criteria:
<br>
<br> - Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ
<br> recipient, immunosuppressant treatment.
<br>
<br> Rheumatic Disease Cohort
<br>
<br> Inclusion Criteria:
<br>
<br> - Diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,
<br> relapsing polychondritis, Behcet disease or juvenile idiopathic arthritis
<br>
<br> - Chronic immunomodulatory treatment with anti-TNF, anti-IL6 or anti-IL17 agents
<br>
<br> Exclusion Criteria:
<br>
<br> - Treatment with more than one biological agent.
<br>
<br> - Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ
<br> recipient, HIV diagnosis.
<br> →
<br> General Inclusion Criteria:
<br>
<br> - Eastern Cooperative Oncology Group < 3
<br>
<br> - Vaccination with 2 doses of Coronavac vaccine
<br>
<br> General Exclusion Criteria:
<br>
<br> - Previous SARS-CoV-2 infection
<br>
<br> - Vaccination with Coronavac more than 12 weeks before informed consent
<br>
<br> - Intravenous immunoglobulin therapy 60 days before informed consent
<br>
<br> - Any condition, that could interfere with the participant's participation during the
<br> study in the opinion of the treating investigator.
<br>
<br> Cancer Cohort
<br>
<br> Inclusion Criteria:
<br>
<br> - Diagnosis of cancer in the previous 5 years (consistent biopsy is required).
<br>
<br> - Life expectancy more than 12 weeks
<br>
<br> Exclusion Criteria:
<br>
<br> - Bone marrow transplant, solid organ recipient, HIV, immunosuppressant treatment for
<br> other condition.
<br>
<br> Bone Marrow Transplant Cohort
<br>
<br> Inclusion Criteria:
<br>
<br> - Bone marrow transplant between January 2019 and December 2020
<br>
<br> Exclusion Criteria:
<br>
<br> - Other cancer diagnosis during the last 5 years, solid organ recipient, HIV,
<br> immunosuppressant treatment for other condition.
<br>
<br> Solid Organ Recipient Cohort:
<br>
<br> Inclusion Criteria:
<br>
<br> - Liver, kidney or heart transplant between January 2019 and December 2020
<br>
<br> - Active immunosuppressant treatment
<br>
<br> Exclusion Criteria:
<br>
<br> - Cancer diagnosis during the last 5 years, bone marrow transplant, immunosuppressant
<br> treatment for other condition, HIV
<br>
<br> HIV Cohort:
<br>
<br> Inclusion Criteria:
<br>
<br> - CD4 <= 500 cels/mm3 documented one year before study enrollment
<br>
<br> - Active antiretroviral therapy
<br>
<br> - Viral load < 200 copies/ml
<br>
<br> Exclusion Criteria:
<br>
<br> - Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ
<br> recipient, immunosuppressant treatment.
<br>
<br> Rheumatic Disease Cohort
<br>
<br> Inclusion Criteria:
<br>
<br> - Diagnosis of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis,
<br> relapsing polychondritis, Behcet disease or juvenile idiopathic arthritis
<br>
<br> - Chronic immunomodulatory treatment with anti-TNF, anti-IL6 or anti-IL17 agents
<br>
<br> Exclusion Criteria:
<br>
<br> - Treatment with more than one biological agent.
<br>
<br> - Cancer diagnosis during the last 5 years, bone marrow transplant or solid organ
<br> recipient, HIV diagnosis.
<br> | | Covid19;COVID-19 Vaccines | Diagnostic Test: Serologic immune response evaluation | Proportion of positive neutralizing antibodies 8 to10 weeks after Coronavac vaccine→Proportion of positive neutralizing antibodies 8 to12 weeks after Coronavac vaccine | | | | Yes | False | | |
| → | NCT04889209 | 1 November 2021→15 November 2021 | Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines | A Phase 1/2 Study of Delayed Heterologous SARS-CoV-2 Vaccine Dosing (Boost) After Receipt of EUA Vaccines | | National Institute of Allergy and Infectious Diseases (NIAID) | 13/05/2021 | 20210513 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04889209 | Recruiting | No | 18 Years | 99 Years | All | May 28, 2021 | 950 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1/Phase 2 | United States | | 21-0012 Central Contact | | DMIDClinicalTrials@niaid.nih.gov | 13017617948 | |
<br> Inclusion Criteria:
<br>
<br> Participants must meet all of the following criteria to be eligible to participate in this
<br> study:
<br>
<br> 1. Individuals >/= 18 years of age at the time of consent.
<br>
<br> 2. Received and completed Coronavirus Disease 2019 vaccine under Emergency Use
<br> Authorization (EUA) dosing guidelines at least 12 weeks prior to enrollment (Cohort 1
<br> only).
<br>
<br> 3. Willing and able to comply with all scheduled visits, vaccination plan, laboratory
<br> tests and other study procedures.
<br>
<br> 4. Determined by medical history, targeted physical examination and clinical judgement of
<br> the investigator to be in good health.*
<br>
<br> * Note: Heathy volunteers with pre-existing stable disease, defined as disease not
<br> requiring significant change in therapy or hospitalization for worsening disease
<br> during the 6 weeks before enrollment, can be included.
<br>
<br> 5. Female participants of childbearing potential may be enrolled in the study, if all of
<br> the following apply:
<br>
<br> - Practiced adequate contraception for 28 days prior to the first dose of vaccine
<br> (Day 1),
<br>
<br> - Has agreed to continue adequate contraception through 3 months following the
<br> booster dose,
<br>
<br> - Has a negative pregnancy test at screening and on the day of the first study
<br> vaccine dose (Day 1),
<br>
<br> - Is not currently breastfeeding.
<br>
<br> Exclusion Criteria:
<br>
<br> Participants meeting any of the following criteria will be excluded from the study:
<br>
<br> 1. Known history of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
<br> infection.
<br>
<br> 2. Prior administration of an investigational coronavirus (SARS Coronavirus (SARS-CoV),
<br> Middle East Respiratory Syndrome (MERS-CoV)) vaccine or SARS Coronavirus 2
<br> (SARS-CoV-2) monoclonal antibody in the preceding 90 days or current/planned
<br> simultaneous participation in another interventional study.
<br>
<br> 3. Receipt of SARS Coronavirus 2 (SARS-CoV-2) vaccine prior to study entry (Cohort 2
<br> only).
<br>
<br> 4. A history of anaphylaxis, urticaria, or other significant adverse reaction requiring
<br> medical intervention after receipt of a vaccine or nanolipid particles.
<br>
<br> 5. Receipt of any investigational study product within 28 days prior to enrollment.
<br>
<br> 6. Received or plans to receive a vaccine within 28 days prior to the first dose (Day 1)
<br> or plans to receive a non-study vaccine within 28 days prior to or after any dose of
<br> study vaccine (with exception for seasonal influenza vaccine within 14 days of study
<br> vaccine).
<br>
<br> 7. Bleeding disorder diagnosed by a doctor (e.g., factor deficiency, coagulopathy, or
<br> platelet disorder requiring special precautions) or significant bruising or bleeding
<br> difficulties with intramuscular injections or blood draws, or previously experienced
<br> thrombosis with thrombocytopenia (TTS) or heparin-induced thrombocytopenia.
<br>
<br> 8. Current or previous diagnosis of immunocompromising condition, immune-mediated
<br> disease, or other immunosuppressive condition.
<br>
<br> 9. Received systemic immunosuppressants or immune-modifying drugs for >14 days in total
<br> within 6 months prior to Screening (for corticosteroids >/= 20 milligram per day of
<br> prednisone equivalent). Topical tacrolimus is allowed if not used within 14 days prior
<br> to Day 1.
<br>
<br> 10. Received immunoglobulin, blood-derived products, within 90 days prior to first study
<br> vaccination.
<br>
<br> 11. An immediate family member or household member of this study's personnel.
<br>
<br> 12. Is acutely ill or febrile 72 hours prior to or at vaccine dosing (fever defined as >/=
<br> 38.0 degrees Celsius or 100.4 degrees Fahrenheit). Participants meeting this criterion
<br> may be rescheduled within the relevant window periods. Afebrile participants with
<br> minor illnesses can be enrolled at the discretion of the investigator.
<br> | | COVID-19 | Biological: Ad26.COV2.S;Biological: BNT162b2;Biological: mRNA-1273;Biological: mRNA-1273.211 | Response rate of SARS-CoV-2 specific antibody binding and neutralization titers;Occurrence of solicited reactogenicity adverse events (AEs);Occurrence of Serious Adverse Events (SAEs).;Occurrence of Related Medically attended adverse events (MAAEs).;Occurrence of New-Onset Chronic Medical Condition (NOCMCs).;Occurrence of Adverse Events of Special Interest (AESIs).;Occurrence of adverse events (AEs);Magnitude of SARS-CoV-2 specific antibody binding and neutralization titers→Magnitude of SARS-CoV-2 specific antibody binding and neutralization titers;Occurrence of adverse events (AEs);Occurrence of Adverse Events of Special Interest (AESIs).;Occurrence of New-Onset Chronic Medical Condition (NOCMCs).;Occurrence of Related Medically attended adverse events (MAAEs).;Occurrence of Serious Adverse Events (SAEs).;Occurrence of solicited reactogenicity adverse events (AEs);Response rate of SARS-CoV-2 specific antibody binding and neutralization titers | | | | Yes | False | | |
| → | NCT04894474 | 2 August 2021→15 November 2021 | A Study to Test Whether BI 767551 Can Prevent COVID-19 in People Who Have Been Exposed to SARS-CoV-2 | A Phase III Randomized, Double-blind, Placebo-controlled, Parallel-group, Group-sequential Study to Evaluate Efficacy, Safety and Tolerability of BI 767551 for Post-exposure Prevention of SARS-CoV-2 Infection in Household Contacts to a Confirmed SARS-CoV-2 Infected Individual | | Boehringer Ingelheim | 18/05/2021 | 20210518 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04894474 | Not recruiting | No | 18 Years | N/A | All | July 13, 2021→June 17, 2021 | 0 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - = 18 years old, males and females
<br>
<br> - Signed and dated written informed consent in accordance with International Council on
<br> Harmonisation - Good Clinical Practice (ICH-GCP) and local legislation prior to
<br> admission to the trial
<br>
<br> - Asymptomatic for Coronavirus Disease 2019 (COVID-19) at time of screening and at
<br> randomization
<br>
<br> - Household contact with exposure to an individual with a diagnosis of Severe acute
<br> respiratory syndrome coronavirus 2 (SARS-CoV-2) infection (i.e. exposure to the index
<br> case)
<br>
<br> - Randomization within 96 hours of collection of the index cases' positive SARS-CoV-2
<br> diagnostic test sample (nucleic acid or antigen-based) from any respiratory tract
<br> specimen (e.g. oropharyngeal, nasopharyngeal (NP), or nasal swab, or saliva); based on
<br> test sample collection date, not the result date.
<br>
<br> - From screening and randomization, the trial participant anticipates living in the same
<br> household with the index case until protocol Day 29.
<br>
<br> - Women of childbearing potential (WOCBP)* and men able to father a child must be ready
<br> and able to use highly effective methods of birth control per International Council on
<br> Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year
<br> when used consistently and correctly.
<br>
<br> - A woman is considered of childbearing potential (WOCBP), i.e. fertile, following
<br> menarche and until becoming post-menopausal unless permanently sterile. Permanent
<br> sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral
<br> oophorectomy. Tubal ligation is NOT a method of permanent sterilisation. A
<br> postmenopausal state is defined as no menses for 24 months without an alternative
<br> medical cause.
<br>
<br> Exclusion Criteria:
<br>
<br> - Body weight of less than 40 kg
<br>
<br> - Residents of skilled nursing facilities. Definition of skilled nursing facility:
<br> assisted living facility that typically provides daily nursing care, 24-hour
<br> supervision, three meals a day, and assistance with everyday activities.
<br>
<br> - History of laboratory confirmed SARS-CoV-2 infection (e.g. antigen or nucleic acid
<br> test)at any time before screening
<br>
<br> - Active respiratory or non-respiratory symptoms consistent with COVID-19, in the
<br> opinion of the investigator
<br>
<br> - History of respiratory or non-respiratory symptoms consistent with COVID-19, within
<br> the prior 6 months to screening, in the opinion of the investigator
<br>
<br> - Participant has lived with individuals who have had previous SARS-CoV-2 infection or
<br> currently lives with individuals who have SARS-CoV-2 infection, with the exception of
<br> the index case(s) who is defined as the first individual(s) known to be infected in
<br> the household
<br>
<br> - Receipt of intravenous immunoglobulin within 12 weeks prior to Visit 2
<br>
<br> - Receipt of COVID-19 convalescent plasma treatment at any time prior to Visit 2
<br>
<br> - Receipt of any SARS-CoV-2 monoclonal antibody treatment at any time prior to Visit 2
<br>
<br> - Receipt of SARS-CoV-2 vaccine at any time prior to Visit 2
<br>
<br> - Receipt of an investigational product for COVID-19 within 5 half-lives prior to Visit
<br> 2
<br>
<br> - Receipt of systemic steroids (e.g. prednisone, dexamethasone) within 4 weeks prior to
<br> Visit 2 unless used for chronic condition
<br>
<br> - Subjects who must or wish to continue the intake of restricted medications or any drug
<br> considered likely to interfere with the safe conduct of the trial
<br>
<br> - Any co-morbidity requiring surgery within 7 days prior to study entry, or that is
<br> considered life threatening in the opinion of investigator within 30 days prior to
<br> randomization
<br>
<br> - Have any serious concomitant systemic disease, condition or disorder that, in the
<br> opinion of the investigator, should preclude participation in this study
<br>
<br> - Subjects not expected to comply with the protocol requirements or not expected to
<br> complete the trial as scheduled (e.g. chronic alcohol or drug abuse or any other
<br> condition that, in the investigator's opinion, makes the subject an unreliable trial
<br> participant)
<br>
<br> - Currently enrolled in any other type of medical research judged not to be compatible
<br> with this study
<br>
<br> - Known allergy/sensitivity or any hypersensitivity to any of the components used in the
<br> formulation of the interventions
<br>
<br> - Previous enrolment in this trial
<br>
<br> - Women who are pregnant, nursing, or who plan to become pregnant while in the trial
<br> | | COVID-19 | Drug: BI 767551 intravenous;Drug: BI 767551 inhalation;Drug: Placebo intravenous;Drug: Placebo inhalation | The primary endpoint of this study is symptomatic SARS-CoV-2 infection (RT-qPCR confirmed based on NP swabs, with a score >= 2 on the WHO Clinical Progression Scale) (Cohort A only) | | | | Yes | False | | |
| → | NCT04895982 | 1 November 2021→15 November 2021 | Study to Evaluate Safety, Tolerability & Immunogenicity of BNT162b2 in Immunocompromised Participants =2 Years | A PHASE 2b, OPEN-LABEL STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF VACCINE CANDIDATE BNT162b2 IN IMMUNOCOMPROMISED PARTICIPANTS =2 YEARS OF AGE | | BioNTech SE | 05/05/2021 | 20210505 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04895982 | Not recruiting→Recruiting | Yes | 2 Years | N/A | All | October 30, 2021→October 15, 2021 | 360 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 2 | United States;Germany;Brazil;Germany;Brazil;United States | ; | Pfizer CT.gov Call Center;Pfizer CT.gov Call Center | | ;ClinicalTrials.gov_Inquiries@pfizer.com | ;1-800-718-1021 | Pfizer; |
<br> Inclusion Criteria:
<br>
<br> - 1. Male or female participants who are =2 years of age at the time of enrollment
<br> (Visit 1).
<br>
<br> 2. Participants or participants' parent(s)/legal guardians, as age appropriate, who
<br> sign consent, and are willing and able to comply with all scheduled visits, treatment
<br> plan, laboratory tests, lifestyle considerations, and other study procedures.
<br>
<br> 3. Life expectancy =12 months (365 days) in the opinion of the investigator at
<br> enrollment (Visit 1).
<br>
<br> 4. Participants or participant's parent(s)/legal guardians, as age appropriate, who
<br> are able to be contacted by telephone throughout the study period.
<br>
<br> 5. Female participant of childbearing potential or male participant able to father
<br> children who is willing to use a highly effective method of contraception as outlined
<br> in this protocol for at least 28 days after the last dose of study intervention if at
<br> risk of pregnancy with her/his partner; or female participant not of childbearing
<br> potential or male participant not able to father children.
<br>
<br> 6. Participants who are immunocompromised by virtue of the following:
<br>
<br> - Having known NSCLC and is =18 years of age with at least 1 of the following:
<br>
<br> - Who received chemotherapy at least 2 weeks (14 days) before enrollment (or is
<br> treatment naïve), and is not expected to receive chemotherapy within at least 2
<br> weeks (14 days) after dose administration; and/or
<br>
<br> - Receiving checkpoint inhibitor treatment (PD-1/PD-L1 inhibitor, CTLA-4 inhibitor)
<br> and has undergone at least 1 treatment cycle prior to enrollment (at Visit 1); or
<br>
<br> - Receiving targeted drug therapy treatment (EGFR, ALK, ROS1, BRAF, RET, MET, NTRK
<br> inhibitors) and has undergone at least 1 treatment cycle prior to enrollment (at
<br> Visit 1); or
<br>
<br> - Having known CLL and is =18 years of age with at least 1 of the following:
<br>
<br> - Has asymptomatic disease (eg, Rai stage <3, Binet stage A or B) and is undergoing
<br> observation and does not receive any treatment for CLL; or
<br>
<br> - Receiving B-cell inhibitory monoclonal antibody treatment (anti-CD20) and has
<br> received at least 3 cycles prior to enrollment; and/or
<br>
<br> - Receives a BTK inhibitor, PI3K inhibitor, or BCL-2 inhibitor OR
<br>
<br> - Is currently undergoing maintenance hemodialysis treatment secondary to end-stage
<br> renal disease and is =18 years of age OR
<br>
<br> - Is on active immunomodulator therapy (eg, TNFa inhibitor, or tofacitinib or
<br> methotrexate) for an autoimmune or inflammatory disease disorder (eg,
<br> inflammatory arthritis, such as rheumatoid arthritis, psoriatic arthritis, and
<br> juvenile idiopathic arthritis, and inflammatory bowel disease, such as ulcerative
<br> colitis and Crohn's disease) at a stable* dose
<br>
<br> - Stable dose is defined as receiving the same dose for at least 3 months (84
<br> days) with no changes in the 28 days prior to Visit 1.
<br>
<br> OR
<br>
<br> - Receiving a solid organ transplant at least 3 months (84 days) prior to enrollment
<br> (Visit 1) and with no acute rejection episodes within 2 months (60 days) prior to
<br> enrollment (Visit 1), and is =2 to <18 years of age OR
<br>
<br> - Has had an autologous or allogenic bone marrow or stem cell transplant at least 6
<br> months (182 days) prior to enrollment (Visit 1), with adequate immune reconstitution
<br> for immunization, in the investigator's opinion, and is =2 to <18 years of age 7. The
<br> participant or participant's parent(s)/legal guardian is capable of giving signed
<br> informed consent, and assent (as appropriate), as described in Appendix 1, which
<br> includes compliance with the requirements and restrictions listed in the ICD and in
<br> this protocol. The investigator, or a person designated by the investigator, will
<br> obtain written informed consent (and assent, as appropriate) from each study
<br> participant or participant's parent(s)/legal guardian (as defined in Appendix 1)
<br> before any study-specific activity is performed. All parent(s)/legal guardians should
<br> be fully informed, and participants should be informed to the fullest extent possible,
<br> about the study in language and terms they are able to understand. The investigator
<br> will retain the original copy of each participant's signed consent (and assent, as
<br> appropriate) document(s).
<br>
<br> Exclusion Criteria:
<br>
<br> - 1. Past clinical (based on COVID-19 symptoms/signs alone, if a SARS CoV 2 NAAT result
<br> was not available) or microbiological (based on COVID-19 symptoms/signs and a positive
<br> SARS-CoV-2 NAAT result) diagnosis of COVID 19, or a past clinical diagnosis of MIS-C.
<br>
<br> 2. Participants with active GVHD, transplant rejection, or PTLD, or participants who
<br> have had treatment for these conditions within 3 months (84 days) prior to study
<br> enrollment (Visit 1).
<br>
<br> 3. Participants <18 years of age whose weight is less than the 5th percentile of
<br> age-adjusted ideal body weight.
<br>
<br> 4. Other medical or psychiatric condition including recent (within the past year) or
<br> active suicidal ideation/behavior or laboratory abnormality that may increase the risk
<br> of study participation or, in the investigator's judgment, make the participant
<br> inappropriate for the study.
<br>
<br> 5. History of severe adverse reaction associated with a vaccine and/or severe allergic
<br> reaction (eg, anaphylaxis) to any component of the study intervention(s).
<br>
<br> 6. Bleeding diathesis or condition associated with prolonged bleeding that would, in
<br> the opinion of the investigator, contraindicate intramuscular injection.
<br>
<br> 7. Participant who is pregnant or breastfeeding. 8. Participants who may be ineligible
<br> because of the number of phlebotomy assessments during this study, in the opinion of
<br> the investigator.
<br>
<br> 9. Participants who do not have adequate deltoid muscle mass to allow intramuscular
<br> vaccination, in the opinion of the investigator.
<br>
<br> 10. Previous vaccination with any coronavirus vaccine. 11. Ongoing, or history of,
<br> treatment with blood/plasma products or immunoglobulins within 3 months (84 days)
<br> prior to Dose 1 or planned receipt of these medications prior to Dose 3.
<br>
<br> 12. Participation in other studies involving study intervention within 28 days prior
<br> to study entry and/or during study participation.
<br>
<br> 13. Previous participation in other studies involving study intervention containing
<br> LNPs.
<br>
<br> 14. Participants who are direct descendants (child or grandchild, parent or
<br> grandparent) of investigational site staff members or Pfizer/BioNTech employees
<br> directly involv | | SARS-CoV-2 Infection, COVID19 | Biological: BNT162b2 | Percentage of participants reporting adverse events;GMTs of all participants, measured by SARS-CoV-2 neutralising titers, without serological or virological evidence of past SARS-CoV-2 infection and with an immunocompromised state, as specified in the protocol;Percentage of participants reporting serious adverse events;Percentage of participants reporting adverse events;Percentage of participants reporting systemic events;Percentage of participants reporting local reactions | | | | Yes | True | parent | |
| → | NCT04896060 | 1 November 2021→15 November 2021 | The Impact of the COVID-19 Pandemic on Eating Behavior and Weight Change | The Impact of the Food Environment and Psychosocial Stress From the COVID-19 Pandemic on Eating Behavior and Weight Change | | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | 19/05/2021 | 20210519 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04896060 | Not recruiting | No | 18 Years | N/A | All | November 3, 2021→November 18, 2021 | 5000 | Observational | | | United States | ; ; | Marci Gluck, Ph.D.;Marci Gluck, Ph.D.;Marci Gluck, Ph.D. | | ;gmarci@mail.nih.gov;gmarci@mail.nih.gov | ;(602) 200-5312;602-200-5312 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); |
<br> - INCLUSION CRITERIA:
<br>
<br> In order to be eligible to participate in this study, an individual must meet all the
<br> following criteria:
<br>
<br> 1. 18 years of age or older
<br>
<br> 2. Able to read and write English
<br>
<br> 3. Consistent access to computer or mobile devices connected to the internet
<br>
<br> 4. Able to provide informed consent online
<br>
<br> In order to be eligible to participate in the EMA arm of the study, an individual must meet
<br> all the following criteria:
<br>
<br> 1. Access to a mobile device with WI-FI and data
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> 1. Non-English-speaking individuals.
<br>
<br> Non-English-speaking subjects as a population will be excluded from participation in this
<br> protocol. The primary aim of the protocol relates to the questionnaires administered to the
<br> participants online. There are currently no validated, translated forms of these
<br> questionnaires available; therefore, we will restrict enrollment to English speaking
<br> subjects only.
<br> | | COVID-19;Obesity | | Nighttime Eating Behavior;The Intuitive Eating Scale-2 (IES-2);Three Factor Eating Questionnaire (TFEQ);Loss of Control Eating;Food Frequency Questionnaire (FFQ);Changes in self-reported weight | | | | Yes | False | | |
| → | NCT04904445 | 7 June 2021→15 November 2021 | COVID-19 Antibody Responses In Cystic Fibrosis | COVID-19 Antibody Responses In Cystic Fibrosis | CAR-CF | Erasmus Medical Center | 17/05/2021 | 20210517 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04904445 | Not recruiting→Recruiting | No | N/A | N/A | All | June 1, 2021→September 21, 2021 | 30 | Observational | | | →Netherlands | ; → ; ; | Damian Downey, Dr;Hettie M Janssens, Dr→Damian Downey, Dr;Hettie M Janssens, Dr;Hettie Janssens, MD, PhD | | ;h.janssens@erasmusmc.nl→;h.janssens@erasmusmc.nl;h.janssens@erasmusmc.nl | ;+31 (0)10 7036263→;+31 (0)10 7036263;+31 10 703 6263 | Queen's University, Belfast; |
<br> Inclusion Criteria:
<br>
<br> - Consenting people with cystic fibrosis of any age, genotype, transplant status and
<br> disease severity.
<br>
<br> Exclusion Criteria:
<br>
<br> - Refusal to give informed consent
<br>
<br> - Contraindication to blood draw
<br> | | Cystic Fibrosis | | To perform a longitudinal comparison;To examine the associations;To evaluate SARS-CoV-2 seroprevalence | | | | Yes | False | | |
| → | NCT04904471 | 1 November 2021→15 November 2021 | A Global Phase III Clinical Trial of Recombinant COVID- 19 Vaccine (Sf9 Cells) | A Global Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Trial to Evaluate the Efficacy, Safety, and Immunogenicity of Recombinant COVID-19 Vaccine (Sf9 Cells), for the Prevention of COVID-19 in Adults Aged 18 Years and Older | | WestVac Biopharma Co., Ltd. | 26/05/2021 | 20210526 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04904471 | Recruiting | No | 18 Years | N/A | All | June 15, 2021 | 40000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | Indonesia;Kenya;Mexico;Philippines;Indonesia;Kenya;Mexico;Philippines;China | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Aged 18 years and older.
<br>
<br> - Able and willing (in the investigator's opinion) to comply with all study
<br> requirements.
<br>
<br> - Willing to allow the investigators to discuss the volunteer's medical history with
<br> their general practitioner/personal doctor and access all medical records which are
<br> relevant to study procedures.
<br>
<br> - Healthy adults, or stable-healthy adults who may have a pre-existing medical condition
<br> that does not meet any exclusion criteria. A stable medical condition is defined as a
<br> disease not requiring significant change in therapy or hospitalization for worsening
<br> disease during the 3 months before enrollment.
<br>
<br> - For females of childbearing potential only, willingness to practice continuous
<br> effective contraception (see glossary) for 90 days after completion of 3 doses
<br> vaccination, and have negative pregnancy tests before each dose vaccination. Note:
<br> Nonchildbearing potential is defined as surgically sterile (history of bilateral tubal
<br> ligation, bilateral oophorectomy, hysterectomy) or postmenopausal (defined as
<br> amenorrhea for = 12 consecutive months prior to Screening without an alternative
<br> medical cause). A follicle-stimulating hormone (FSH) level may be measured at the
<br> discretion of the investigator to confirm postmenopausal status.
<br>
<br> - Males participating in this study who are involved in heterosexual sexual activity
<br> must agree to practice adequate contraception (see glossary) and refrain from donating
<br> sperm for 90 days after receiving the study vaccination.
<br>
<br> - Agreement to refrain from blood donation during the study.
<br>
<br> - Provide a written informed consent form (ICF)
<br>
<br> Exclusion Criteria:
<br>
<br> Exclusion criteria for the first dose
<br>
<br> - Participation in any other COVID-19 prophylactic drug trials during the duration of
<br> the study.
<br>
<br> Note: Participation in COVID-19 treatment trials is allowed in the event of hospitalization
<br> due to COVID-19. The study team should be informed as soon as possible.
<br>
<br> - Positive HIV antibody testing results.
<br>
<br> - Participation in SARS-CoV-2 serological surveys where participants are informed of
<br> their serostatus during the duration of the study.
<br>
<br> Note: Disclosure of serostatus post enrolment may accidentally unblind participants to
<br> group allocation. Participation in this trial can only be allowed if volunteers are kept
<br> blinded to their serology results from local/national serological surveys
<br>
<br> - Planned receipt of any licensed or investigational vaccine, other than the study
<br> intervention,within 14 days before and after study vaccination.
<br>
<br> - Prior receipt of an investigational or licensed COVID-19 vaccine.
<br>
<br> - Administration of immunoglobulins and/or any blood products within three months prior
<br> to the planned administration of the investigational products (IPs).
<br>
<br> - Any confirmed or suspected immunosuppressive or immunodeficient state; positive HIV
<br> status;asplenia; recurrent severe infections and chronic use (more than 14 days) of
<br> immunosuppressant medication within the past 6 months. Topical steroids or short-term
<br> (course lasting =14 days) oral steroids are not exclusion criteria.
<br>
<br> - History of allergic disease or reactions likely to be exacerbated by any component of
<br> Recombinant COVID-19 Vaccine (Sf9 cells).
<br>
<br> - Any history of angioedema
<br>
<br> - Pregnancy, lactation, or willingness/intention to become pregnant within 90 days after
<br> receiving study vaccine
<br>
<br> - Current diagnosis or treatment of cancer (except basal cell carcinoma of the skin and
<br> cervical carcinoma in situ)
<br>
<br> - History of serious psychiatric condition likely to affect participation in the study
<br>
<br> - A bleeding disorder (e g factor deficiency coagulopathy or platelet disorder) or prior
<br> history of significant bleeding or bruising following IM injections or venipuncture
<br>
<br> - Suspected or known current alcohol or drug dependency
<br>
<br> - Severe and/or uncontrolled cardiovascular disease, respiratory disease,
<br> gastrointestinal disease,liver disease, renal disease, an endocrine disorder, and
<br> neurological illness (mild/moderate well-controlled comorbidities are allowed)
<br>
<br> - History of laboratory-confirmed COVID-19
<br>
<br> - Continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e.
<br> warfarin) or novel oral anticoagulants (i.e. apixaban, rivaroxaban, dabigatran, and
<br> edoxaban)
<br>
<br> - Any other significant disease, disorder, or finding which may significantly increase
<br> the risk to the volunteer because of participation in the study, affect the ability of
<br> the volunteer to participate in the study, or impair interpretation of the study data.
<br>
<br> Exclusion criteria for the second/third dose In this trial, the second/third dose
<br> vaccination may be terminated in some cases. These include systemic allergic reactions,
<br> severe hypersensitivity reactions, or intolerable grade 3 or higher adverse reactions after
<br> the previous vaccination/placebo. If these reactions occur, the participants should not
<br> continue to receive the second/third vaccination.
<br> | | COVID-19 | Biological: Recombinant COVID-19 vaccine (Sf9 cells);Other: Placebo control | Virologically confirmed (polymerase chain reaction(PCR) positive) symptomatic COVID-19 cases first occurring, regardless of severity.;The incidence of serious adverse events(SAEs).;The incidence of adverse event of special interests(AESIs).;The incidence of medically attended adverse events(MAAEs).;The incidence of solicited adverse events(AEs).;The incidence of unsolicited adverse events(AEs) . | | | | Yes | False | | |
| → | NCT04909905 | 20 September 2021→15 November 2021 | Glutamine Supplementation and Short-term Mortality in Covid-19 | The Impact of Glutamine Supplementation Upon the Short-term Mortality of COVID-19 Diseased Patients Admitted in ICU: A Double Blind Randomized Clinical Trial | | Assiut University | 30/05/2021 | 20210530 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04909905 | Recruiting→Not recruiting | No | 18 Years | N/A | All | May 30, 2021 | 60 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider). | Phase 3 | Egypt | ; ; → | Omar Soliman, MD;Omar Soliman, MD;Omar Soliman→Omar Soliman, MD | | ;omarmakram347@yahoo.com;omarmakram347@yahoo.com→ | ;01101266040;01101266040→ | Omar makram;→Omar makram |
<br> Inclusion Criteria:
<br>
<br> - Diagnosis of covid-19 diseased patients admitted to the ICU with enteral nutrition.
<br>
<br> Exclusion Criteria:
<br>
<br> - Renal failure (creatinine >180 mmol/l)
<br>
<br> - Hepatic failure (bilirubin >40 mmol/l, alanine aminotransferase >100 U/l and aspartate
<br> aminotransferase >100 U/l)
<br>
<br> - Severe neutropenia (<500 cells/mm3)
<br>
<br> - Patients receiving cytotoxic, radiation and/or steroid therapy
<br>
<br> - Hemodynamic instability
<br> | | Covid19 | Dietary Supplement: Standard enteral nutrition;Combination Product: Glutamine | ICU mortality | | | | Yes | False | | |
| → | NCT04910269 | 11 October 2021→15 November 2021 | Outpatient Treatment With Anti-Coronavirus Immunoglobulin | An International Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial of the Safety and Efficacy of Anti-Coronavirus Hyperimmune Intravenous Immunoglobulin for the Treatment of Adult Outpatients in Early Stages of COVID-19 | OTAC | University of Minnesota | 01/06/2021 | 20210601 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04910269 | Recruiting | Yes | 18 Years | N/A | All | August 6, 2021 | 820 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States→United States;Denmark;United States | ; | James Neaton, PhD;Gary Collins | | ;gary-c@ccbr.umn.edu | ;612-626-9006 | University of Minnesota; |
<br> Inclusion Criteria:
<br>
<br> - Clinical risk based on age = 55 years or an adult (age = 18 years) with an
<br> immunosuppressed condition.
<br>
<br> - Positive test for SARS-CoV-2 within =5 days (if >1 test, the first positive is within
<br> =5 days). Tests may include an institutional-based nucleic acid amplification test
<br> (NAAT), or any protocol-approved rapid test.
<br>
<br> - Within =5 days from symptom onset, if symptomatic from current SARS-CoV-2 infection.
<br>
<br> - Agrees to not participate in another clinical trial for the treatment or management of
<br> SARS-CoV-2 infection through Day 7, or until hospitalized or significant disease
<br> progression if prior to Day 7 (defined by ordinal category 4 or 5).
<br>
<br> - Participant provides written informed consent prior to study procedures, and
<br> understands and agrees to adhere to planned study procedures through Day 28.
<br>
<br> Ongoing immunosuppressive condition or immunosuppressive treatment, includes:
<br>
<br> 1. Steroids equivalent to prednisone > 10 mg/day for at least the last 28 days
<br>
<br> 2. Rheumatologic or autoimmune disorder treated with a biologic or non-biologic
<br> immunosuppressive therapy
<br>
<br> 3. Antirejection medicine after solid organ or stem cell transplantation
<br>
<br> 4. Cancer treatment with systemic chemotherapy, biologic and/or cell-based therapy in the
<br> last 12 months
<br>
<br> 5. Primary or acquired severe B- or T-lymphocyte immune dysfunction
<br>
<br> 6. HIV infection
<br>
<br> 7. Splenectomy or functional asplenia
<br>
<br> Exclusion Criteria:
<br>
<br> - Asymptomatic and had prior symptoms from the current infection that have now resolved
<br> (for >24 hours).
<br>
<br> - Asymptomatic and has received a vaccination for COVID-19 (=1 dose).
<br>
<br> - Undergoing evaluation for possible admission to hospital for medical management (this
<br> does not include evaluation of possible hospitalization for public health purposes).
<br>
<br> - Evidence of pneumonia and/or hypoxia due to COVID-19 (NOTE: chest imaging is not
<br> required, but if available it should not show new infiltrates suggestive of pneumonia;
<br> hypoxia is defined by new oxygen supplementation or increase above pre-illness level).
<br>
<br> - Prior receipt of immunoglobulin product or passive immune therapy for SARS-CoV-2 in
<br> the past 90 days (i.e., convalescent plasma, SARS-CoV-2 monoclonal antibodies, or any
<br> IVIG).
<br>
<br> - Any of the following thrombotic or procoagulant conditions or disorders:
<br>
<br> 1. acute coronary syndrome, cerebrovascular syndrome, pulmonary embolism, or deep
<br> venous thrombosis within 28 days of randomization.
<br>
<br> 2. prothrombin gene mutation 20210, homozygous Factor V Leiden mutations,
<br> antiphospholipid syndrome, or a deficiency in antithrombin III, protein C, or
<br> protein S.
<br>
<br> - History of hypersensitivity to blood, plasma or IVIG excipients.
<br>
<br> - Known IgA deficiency or anti-IgA antibodies.
<br>
<br> - Medical conditions for which receipt of a 300 mL volume of IV fluid from study
<br> treatment may pose specific risk to the patient (e.g., decompensated congestive heart
<br> failure).
<br>
<br> - In the opinion of the investigator, any condition for which participation would not be
<br> in the best interest of the participant or that could prevent or confound protocol
<br> assessments.
<br> | | COVID;SARS-CoV2 Infection;Covid19 | Biological: Hyperimmune immunoglobulin to SARS-CoV-2 (hIVIG);Other: Placebo | Clinical Status | | | | Yes | True | parent →child | |
| → | NCT04920942 | 28 June 2021→15 November 2021 | Ivermectin Treatment Efficacy in Covid-19 High Risk Patients | Ivermectin Treatment Efficacy in Covid-19 High Risk Patients (I-TECH Study): A Multicenter Open-label Randomized Controlled Trial | I-TECH | Clinical Research Centre, Malaysia | 31/05/2021 | 20210531 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04920942 | Recruiting→Not recruiting | No | 50 Years | 100 Years | All | June 1, 2021 | 500 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Investigator). | Phase 4 | Malaysia | ; → | CHEE L LIM, MRCP;STEVEN CL LIM, MRCP→CHEE L LIM, MRCP | | ;stevenlimcl@gmail.com→ | ;60133620081→ | Ministry of Health, Malaysia;→Ministry of Health, Malaysia |
<br> Inclusion Criteria:
<br>
<br> 1. RT-PCR confirmed COVID-19 cases
<br>
<br> 2. Aged 50 years and above,with at least one co-morbidities*
<br>
<br> 3. Within the first 7 days of illness (from symptom onset)
<br>
<br> 4. Mild to moderate clinical severity
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Asymptomatic stage 1 patients
<br>
<br> 2. Patients with SpO2 less than 95% at rest. (unless it is an expected baseline SpO2 due
<br> to preexisting disease, eg. COAD or pulmonary fibrosis)
<br>
<br> 3. Patients who need oxygen supplements
<br>
<br> 4. Patients with concomitant bacterial, fungal, parasitic or other viral infections prior
<br> to enrollment.
<br>
<br> 5. Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal
<br> limit)
<br>
<br> 6. Malabsorptionsyndromeorotherclinicallysignificantgastrointestinaldisease that may
<br> affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative
<br> colitis, and others).
<br>
<br> 7. Pregnant or nursing women or women planning pregnancy.
<br>
<br> 8. Female patients who cannot consent to contraceptive use of oral contraceptives,
<br> mechanical contraceptives such as intrauterine devices or barrier devices (pessaries,
<br> condoms), or a combination of these devices from the start of ivermectin
<br> administration to 7 days after the end of ivermectin administration
<br>
<br> 9. Male patients whose partner cannot agree to use the contraception method described in
<br> (8) above
<br>
<br> 10. Patients receiving chemotherapy
<br>
<br> 11. Patients who received interferon or drugs with reported antiviral activity against
<br> COVID-19 (favipiravir, hydroxychloroquine sulfate, chloroquine phosphate,
<br> lopinavir-ritonavir combination, remdesivir) in the past 7 days before enrollment.
<br>
<br> 12. Patients in whom this episode of infection is a recurrence or reinfection of COVID-
<br> 19.
<br>
<br> 13. Patients who have previously received ivermectin.
<br>
<br> 14. Patient receiving warfarin or any medications known to interact with ivermectin.
<br>
<br> 15. Patients who are not able to provide written consent.
<br>
<br> 16. Other patients judged ineligible by the principal investigator or sub-investigator.
<br> →
<br> Inclusion Criteria:
<br>
<br> 1. RT-PCR confirmed COVID-19 cases
<br>
<br> 2. Aged 50 years and above,with at least one co-morbidities*
<br>
<br> 3. Within the first 7 days of illness (from symptom onset)
<br>
<br> 4. Mild to moderate clinical severity
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Asymptomatic stage 1 patients
<br>
<br> 2. Patients with SpO2 less than 95% at rest. (unless it is an expected baseline SpO2 due
<br> to preexisting disease, eg. COAD or pulmonary fibrosis)
<br>
<br> 3. Patients who need oxygen supplements
<br>
<br> 4. Patients with concomitant bacterial, fungal, parasitic or other viral infections prior
<br> to enrollment.
<br>
<br> 5. Patients with severe hepatic impairment (>Grade 3: ALT >10 times of upper normal
<br> limit)
<br>
<br> 6. Malabsorptionsyndromeorotherclinicallysignificantgastrointestinaldisease that may
<br> affect absorption of the study drug (non-correctable vomiting, diarrhea, ulcerative
<br> colitis, and others).
<br>
<br> 7. Pregnant or nursing women.
<br>
<br> 8. Female patients of reproductive age who cannot consent to contraceptive use of oral
<br> contraceptives, mechanical contraceptives such as intrauterine devices or barrier
<br> devices (pessaries, condoms), or a combination of these devices from the start of
<br> ivermectin administration to 7 days after the end of ivermectin administration
<br>
<br> 9. Male patients whose partner cannot agree to use the contraception method described in
<br> (8) above
<br>
<br> 10. Patients receiving chemotherapy
<br>
<br> 11. Patients who received interferon or drugs with reported antiviral activity against
<br> COVID-19 (favipiravir, hydroxychloroquine sulfate, chloroquine phosphate,
<br> lopinavir-ritonavir combination, remdesivir) in the past 7 days before enrollment.
<br>
<br> 12. Patients in whom this episode of infection is a recurrence or reinfection of COVID-
<br> 19.
<br>
<br> 13. Patients who have previously received ivermectin.
<br>
<br> 14. Patient receiving warfarin or any medications known to interact with ivermectin.
<br>
<br> 15. Acute medical or surgical emergency (eg. DKA/MI/stroke).
<br>
<br> 16. Other patients judged ineligible by the principal investigator or sub-investigator.
<br> | | COVID-19 | Drug: Ivermectin 0.4mg/kg/day for 5 days | Time Required for Patients on Treatment Arm to Progressed to Severe Disease (Clinical stage 4 or 5);Number of Patients who Progressed to Severe Disease (Clinical stage 4 or 5) | | | | Yes | False | | |
| → | NCT04927442 | 1 November 2021→15 November 2021 | Natural History Study of COVID-19 Using Digital Wearables | A Prospective Natural History Study of COVID-19 Using Digital Wearables | | National Institute on Minority Health and Health Disparities (NIMHD) | 15/06/2021 | 20210615 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04927442 | Recruiting | No | 18 Years | 65 Years | All | November 3, 2021→November 18, 2021 | 550 | Observational | | | United States | ; ; | Sherine M El-Toukhy, Ph.D.;Sherine M El-Toukhy, Ph.D.;For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) | | ;sherine.el-toukhy@nih.gov;prpl@cc.nih.gov | ;(301) 594-4743;800-411-1222 | National Institute on Minority Health and Health Disparities (NIMHD); |
<br> - INCLUSION CRITERIA:
<br>
<br> To be eligible to participate in this study, an individual must meet all the following
<br> criteria:
<br>
<br> - Stated willingness to comply with all study procedures and availability for the
<br> duration of the study.
<br>
<br> - Male or female, aged 18 to 65. The pediatric population <18 years differs from adults
<br> >18 years in infection rates, symptom manifestation, and outcomes (e.g., multi-
<br> inflammatory syndrome). Although population 12 and older is now eligible to receive
<br> the vaccine, population over 65 was the first eligible age group to receive the
<br> vaccine in the US. Furthermore, protections are in place to reduce transmission among
<br> the elderly in general and in nursing homes in particular.
<br>
<br> - Documentation of a SARS-Cov-19 positive test (PCR or antigen/rapid test) <=5 days
<br> before enrollment. Recruitment materials list patients must be within 3 days of a
<br> positive test, which gives the research team 2 days to enroll patients in the study.
<br> Self-collection
<br>
<br> kits and home tests for COVID-19 are not permitted because of the potential for
<br> inappropriate sampling and sample contamination.
<br>
<br> - Owns or has access to supported device (i.e., smartphone or a tablet) that compliant
<br> with the specifications listed below and with an existing cellular data plan:
<br>
<br> 1. Android phones and tables with an operating system of 6.0 or newer (6.0,
<br> Bluetooth 4.2 or Bluetooth 5.0 support, and which implement Bluetooth Low Energy
<br> (BLE) standard)
<br>
<br> 2. iPhone SE (1st, 2nd generation), 6s/6s plus, 7/7 plus, 8/8 plus, X, XS, XR, 11,
<br> 11 Pro, 11 Pro Max, 12, 12 Mini, 12 Pro, 12 Pro Max
<br>
<br> 3. iPad mini 4; iPad mini (5th generation), iPad (5th, 6th, 7th, 8th generation);
<br> iPad Air 2; iPad Air (3rd, 4th generation); 9.7- inch iPad Pro; 10.5-inch iPad
<br> Pro; 11-inch iPad pro (1st, 2nd, and 3rd generation); 12.9-inch iPad pro (1st,
<br> 2nd, 3rd, 4th, 5th generation)
<br>
<br> 4. Devices released in 2021 and afterward that are compatible with the Biostrap app.
<br>
<br> - Speaks English. Non-English speakers will be unable to use the Biostrap mobile app.
<br> Although efforts are currently underway to provide the app in Spanish, the current app
<br> is only available in English.
<br>
<br> - Agreement to adhere to lifestyle considerations throughout the study duration (i.e.,
<br> wear a digital wristband and temperature patch).
<br>
<br> - Ability of subject to understand and willingness to consent to the participate.
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> An individual who meets any of the following criteria will be excluded from participation
<br> in this study:
<br>
<br> - Enrollment in clinical trials on experimental COVID-19 therapeutics at baseline.
<br> Patients will be instructed to alert the NIMHD research team if a patient participates
<br> in a clinical trial after enrollment in this study.
<br>
<br> - Upon recruitment, requires invasive or non-invasive assisted ventilation.
<br>
<br> - Inability to consent.
<br>
<br> - Unwillingness to comply with study procedures (i.e., wearing a wristband and
<br> temperature patch, downloading a mobile application, providing proof of positive
<br> COVID-19 test, providing data required for the study such as medical history data and
<br> contact information for two close kin).
<br>
<br> - Participants residing outside US mainland.
<br> | | COVID-19 Virus Disease | | COVID 19 Symptoms Monitoring | | | | Yes | False | | |
| → | NCT04930861 | 17 August 2021→15 November 2021 | Study of Codivir in Patients With COVID-19 | Phase 1 Clinical Study of Codivir in Outpatients With COVID-19 | Codivir | Code Pharma | 16/06/2021 | 20210616 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04930861 | Not recruiting | No | 18 Years | 60 Years | All | March 29, 2021 | 12 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | Brazil | | Eynat Finkelshtein | | | | Code Pharma |
<br> Inclusion Criteria:
<br>
<br> 1. Age between 18 and 60 years;
<br>
<br> 2. Male or female;
<br>
<br> 3. SARS-CoV-2 infection indicated by rapid test and confirmed by RT-PCR.
<br>
<br> 4. Mild or moderate COVID-19:
<br>
<br> - The oxygen saturation in room air >93%;
<br>
<br> - <30 breaths per minute;
<br>
<br> 5. No signs of hemodynamic decompensation.
<br>
<br> 6. Absence of pregnancy in women of childbearing age.
<br>
<br> 7. Able to understand and comply with the requirements of the protocol.
<br>
<br> 8. Consent to participate
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Participants in need of O2 supplementation by catheter or mask, invasive mechanical
<br> ventilation, or vasopressors.
<br>
<br> 2. Onset of symptoms or rapid test or positive RT-PCR for more than 72 hours of
<br> inclusion.
<br>
<br> 3. Participants in use or expected to use within 24 hours prior to the inclusion of drugs
<br> that are under clinical investigation as a therapeutic option for the treatment of
<br> COVID-19 (eg hydroxychloroquine, chloroquine, ivermectin, nitazoxanide, among others)
<br> during the study period;
<br>
<br> 4. Body mass index less than 19.9 or greater than 35;
<br>
<br> 5. Comorbidities such as: other serious infections, active malignancies, autoimmune
<br> diseases, liver, kidney or heart failure; another systemic disease and / or laboratory
<br> abnormality, which, in the investigator's opinion, prevent the patient from
<br> participating in the study;
<br>
<br> 6. Concomitant HIV, HBV or HCV infection.
<br>
<br> 7. Pregnancy or lactation;
<br>
<br> 8. Participation in another clinical trial in the 12 months preceding inclusion;
<br>
<br> 9. Anti-COVID-19 vaccination at any time;
<br>
<br> 10. Vaccination for any other infection in the 4 weeks prior to inclusion;
<br>
<br> 11. Any condition that increases the risk of participating in the study, in the opinion of
<br> the investigator.
<br> | | Covid19 | Drug: Covidir injections;Diagnostic Test: One Step Test;Diagnostic Test: IgM and IgG dosage;Diagnostic Test: RT-PCR SARS-CoV-2;Diagnostic Test: Screening blood test;Diagnostic Test: ECG;Diagnostic Test: Medical evaluation;Diagnostic Test: NEWS-2 score;Diagnostic Test: WHO score | Incidence and severity of adverse events related to the investigational product. | | | | Yes | False | | |
| → | NCT04933474 | 5 July 2021→15 November 2021 | Pragmatic Comparative Effectiveness Trial of Evidence-based, On-demand, Digital Behavioral Treatments for Chronic Pain | Transcending COVID-19 Barriers to Pain Care in Rural America: Pragmatic Comparative Effectiveness Trial of Evidence-based, On-demand, Digital Behavioral Treatments for Chronic Pain | | Cedars-Sinai Medical Center | 18/06/2021 | 20210618 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04933474 | Not recruiting | No | 13 Years | 99 Years | All | October 1, 2021→February 1, 2022 | 300 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Triple (Participant, Care Provider, Outcomes Assessor). | N/A | United States | ; ; | Brennan Spiegel, MD, MSHS;Xiaoyu Liu, MPH;Taylor Dupuy, BA | | ;xiaoyu.liu@cshs.org;Taylor.Dupuy@cshs.org | ;3104236723;310-423-6450 | Cedars-Sinai Medical Center; |
<br> Inclusion Criteria:
<br>
<br> - have chronic pain, from any underlying condition, using the administrative definition
<br> of ICD-10 code series G89.X or one or more of 134 chronic overlapping pain condition
<br> codes, as previously standardized and validated by an expert panel;
<br>
<br> - have experienced average pain intensity of >3 out of 10 within the previous week;
<br>
<br> - are >13 years of age;
<br>
<br> - are able to read/write English;
<br>
<br> - have either a personal computer or a smartphone;
<br>
<br> - live in a designated rural zip code as defined by the Federal Office of Rural Health
<br> Policy (FORHP) data (RUCA Codes 4-10).
<br>
<br> Exclusion Criteria:
<br>
<br> - have a condition that interferes with use of the intervention (e.g., visual
<br> impairment);
<br>
<br> - are hospitalized;
<br>
<br> - are receiving active cancer treatment;
<br>
<br> - are receiving end-of-life care;
<br>
<br> - have cognitive impairment that affects participation.
<br> | | Chronic Pain | Behavioral: painTRAINER®;Device: PICO G2 4k | Daily Pain Intensity | | | | Yes | False | | |
| → | NCT04934020 | 18 October 2021→15 November 2021 | Global Impact of the COVID 19 Pandemic on Stroke Care, Cerebral Venous Thrombosis, and Subarachnoid Hemorrhage | Global Impact of the COVID 19 Pandemic on Stroke Care: 1-year Follow-up Study | | Boston Medical Center | 20/06/2021 | 20210620 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04934020 | Recruiting→Not recruiting | No | 18 Years | N/A | All | April 25, 2021 | 10000→100000 | Observational | | | United States | ; ; → ; | Thanh N Nguyen;Raul G Nogueira, MD;Thanh N Nguyen, MD→Thanh N Nguyen;Raul G Nogueira, MD | | ;;thanh.nguyen@bmc.org→; | ;;617-638-9022→; | Boston Medical Center;Grady Memorial Hospital, Emory University;→Boston Medical Center;Grady Memorial Hospital, Emory University |
<br> Inclusion Criteria:
<br>
<br> - Received stroke related care during the study period in one of the stroke centers
<br> across 6 continents
<br>
<br> Exclusion Criteria:
<br>
<br> - None
<br> | | Stroke | Other: Pre-pandemic stroke related metrics;Other: Stroke related metrics during the pandemic | Trends in stroke metrics before and during the covid pandemic;Vaccination impact on stroke metrics | | | | Yes | False | | |
| → | NCT04939428 | 1 November 2021→15 November 2021 | Study of MK-4482 for Prevention of Coronavirus Disease 2019 (COVID-19) in Adults (MK-4482-013) | A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of MK-4482 for the Prevention of COVID-19 (Laboratory-confirmed SARS-CoV-2 Infection With Symptoms) in Adults Residing With a Person With COVID-19 | MOVe-AHEAD | Merck Sharp & Dohme Corp. | 24/06/2021 | 20210624 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04939428 | Recruiting | Yes | 18 Years | N/A | All | August 11, 2021 | 1332 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Investigator, Outcomes Assessor). | Phase 3 | Spain;Turkey;Ukraine;United States;Russian Federation;Romania;Mexico;Japan;Hungary;Guatemala;France;Colombia;Brazil;Argentina;Ukraine;Turkey;Spain;Russian Federation;Romania;Mexico;Japan;Hungary;Guatemala;France;Colombia;Brazil;Argentina;United States | ; | Medical Director;Toll Free Number | | ;Trialsites@merck.com | ;1-888-577-8839 | Merck Sharp & Dohme Corp.; |
<br> Inclusion Criteria:
<br>
<br> - Lives in a household with an index case where the index case is a person with
<br> documented COVID-19 (laboratory-confirmed SARS-CoV-2 infection with symptoms case) and
<br> must have 1) a first positive SARS-CoV-2 test result from a sample collected within =5
<br> days prior to randomization of the participant, and 2) at least 1 symptom attributable
<br> to COVID-19 (e.g., fever, difficulty breathing)
<br>
<br> - Does not have confirmed or suspected COVID-19
<br>
<br> - Is willing and able to take oral medication
<br>
<br> - Is male and willing to be abstinent from heterosexual intercourse or use acceptable
<br> contraception during the study and for =4 days after the last dose of study
<br> intervention
<br>
<br> - Is female and not pregnant/breastfeeding and at least one of the following applies
<br> during the study and for =4 days after: is not a woman of childbearing potential
<br> (WOCBP), is a WOCBP and uses highly effective contraception (low user dependency
<br> method OR a user dependent hormonal method in combination with a barrier method), or
<br> is a WOCBP who is abstinent from heterosexual intercourse
<br>
<br> Exclusion Criteria:
<br>
<br> - Has a prior history of laboratory-confirmed SARS-CoV-2 infection (with or without
<br> symptoms) or has a prior positive test results for anti-SARS-CoV-2 antibodies
<br>
<br> - Is on dialysis or has renal impairment
<br>
<br> - Has either of the following: 1) human immunodeficiency virus (HIV) with a recent viral
<br> load >50 copies/mL (regardless of CD4 count) or an acquired immunodeficiency syndrome
<br> (AIDS)-defining illness; or 2) neutrophilic granulocyte absolute count <500/mm^3
<br>
<br> - Has a history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with any
<br> of the following: cirrhosis, end-stage liver disease, hepatocellular carcinoma;
<br> aspartate transaminase (AST) and/or (ALT) >3x upper limit of normal at screening
<br>
<br> - Has a low platelet count or received a platelet transfusion within 5 days prior to
<br> randomization
<br>
<br> - Has hypersensitivity or other contraindication to any of the components of the study
<br> interventions as determined by the investigator
<br>
<br> - Has any condition for which, in the opinion of the investigator, participation would
<br> not be in the best interest of the participant or that could prevent, limit, or
<br> confound the protocol-specified assessments including but not limited to participants
<br> with conditions that could limit gastrointestinal absorption of capsule contents
<br>
<br> - Has received, is taking, or is anticipated to require any prohibited therapies
<br>
<br> - Has received a COVID-19 vaccination with the first dose =7 days prior to randomization
<br>
<br> - Is unwilling to abstain from participating in another interventional clinical study
<br> through Day 29 with an investigational compound or device, including those for
<br> COVID-19 therapeutics
<br>
<br> - Has more than 1 individual currently (assessed at the time of consent), or within the
<br> last month, living in the household with confirmed or suspected COVID-19
<br>
<br> - Is living in a household with >10 people
<br> | | Coronavirus Disease (COVID-19) | Drug: Molnupiravir;Drug: Placebo | Percentage of participants discontinuing from study therapy due to AE;Percentage of participants with =1 adverse event;Percentage of participants with COVID-19 (laboratory-confirmed severe acute respiratory syndrome coronavirus 2 [SARS-CoV-2] infection with symptoms) through Day 14 | | | | Yes | True | parent | |
| → | NCT04949412 | 12 July 2021→15 November 2021 | Assessment of Vitamin D Level in COVID-19 | Assessment of Serum Vitamin D Level in COVID-19 Infected Patients | COVID19 | Sohag University | 30/06/2021 | 20210630 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04949412 | Recruiting→Not recruiting | No | N/A | N/A | All | June 11, 2021 | 100→98 | Observational [Patient Registry] | | | Egypt | ; ; ; ; ; ; → ; ; ; ; | Mustafa Haridy, Deminstrator;Mohamed Mahmoud, lecturer;Ahmed Nour-Eldin, lecturer;Asmaa Khalaf, lecturer;Amira Maher, lecturer;Mona Abdelrahmam, Lecturer;Mona Abdelrahman, lecturer→Mustafa Haridy, Deminstrator;Mohamed Mahmoud, lecturer;Ahmed Nour-Eldin, lecturer;Asmaa Khalaf, lecturer;Amira Maher, lecturer | | ;;;;;monamohamed@med.sohag.edu.eg;→;;;; | ;;;;;01021025895;01021025895→;;;; | Al-Azahar University;Sohag University;Sohag University;Sohag University;Sohag University;→Al-Azahar University;Sohag University;Sohag University;Sohag University;Sohag University |
<br> Inclusion Criteria:
<br>
<br> Patients with SARS-CoV2 positive PCR
<br>
<br> Exclusion Criteria:
<br>
<br> Patients with chronic obstructive lung disease Chronic renal failure Patients with
<br> malabsorption Organ transplant recipient Pregnant women
<br> | | Covid19 | Diagnostic Test: Vitamin D | serum level of vitamin D in patients who infected with COVID19 | | | | Yes | False | | |
| → | NCT04951388 | 18 October 2021→15 November 2021 | A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adolescents | A Phase II, Prospective, Double-blinded, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS CoV 2 Vaccine Candidate MVC COV1901 in Adolescents | | Medigen Vaccine Biologics Corp. | 30/06/2021 | 20210630 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04951388 | Recruiting→Not recruiting | No | 12 Years | 18 Years | All | July 22, 2021 | 385→399 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2 | Taiwan | ; → | Li-Min Huang, M.D., Ph.D.;Tim Huang→Li-Min Huang, M.D., Ph.D. | | ;ChunHao@medigenvac.com→ | ;+886277450830→ | National Taiwan University Hospital;→National Taiwan University Hospital |
<br> Inclusion Criteria:
<br>
<br> - Male or female participant = 12 to < 18 years of age at randomization.
<br>
<br> - Body mass index (BMI) at or above the third percentile according to World Health
<br> Organization (WHO) BMI-for-age at the Screening Visit.
<br>
<br> - Female participant must:
<br>
<br> 1. Be either of non-childbearing potential, i.e. surgically sterilized (defined as
<br> having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral
<br> salpingectomy; tubal ligation alone is not considered sufficient);
<br>
<br> 2. Or, if of childbearing potential, be abstinent or agree to use medically
<br> effective contraception from 14 days before screening to 30 days following the
<br> last injection of study intervention. Acceptable forms include:
<br>
<br> i. Implanted hormonal methods of contraception or placement of an intrauterine device
<br> or intrauterine system ii. Established use of hormonal methods (injectable, pill,
<br> patch or ring) combined with barrier methods of contraception: condom or occlusive cap
<br> (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
<br>
<br> - Has a negative pregnancy test
<br>
<br> - Participant is willing and able to comply with all required study visits and follow-up
<br> required by this protocol.
<br>
<br> - Participant has not travelled overseas within 14 days of screening and will not have
<br> any oversea traveling throughout the study period.
<br>
<br> - Participant and the participant's legal representative must understand the procedures
<br> of the study and provide written informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Pregnant or breast feeding or have plan to become pregnant in 30 days after last
<br> administration of study intervention.
<br>
<br> - Currently receiving or received any investigational intervention within 30 days prior
<br> to the first dose of study intervention.
<br>
<br> - Participant previously received a coronavirus vaccine.
<br>
<br> - Administered any licensed live-attenuated vaccines within 28 days or other licensed
<br> non-live-attenuated vaccines within 7 days prior to the first dose of study
<br> intervention.
<br>
<br> - Administered any blood product or intravenous immunoglobulin administration within 12
<br> weeks prior to the first dose of study intervention.
<br>
<br> - Currently receiving or anticipate to receive concomitant immunosuppressive or
<br> immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing
<br> corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone
<br> less than 20 mg or equivalent) within 12 weeks prior to the first dose of study
<br> intervention.
<br>
<br> - Currently receiving or anticipate to receive treatment with tumor necrosis factor
<br> (TNF)-a inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to
<br> the first dose of study intervention.
<br>
<br> - Major surgery or any radiation therapy within 12 weeks prior to the first dose of
<br> study intervention
<br>
<br> - Immunosuppressive illness or immunodeficient state, including hematologic malignancy,
<br> history of solid organ, bone marrow transplantation, or asplenia.
<br>
<br> - Personal or family (linear or collateral relatives by blood within two generations)
<br> history of Guillain-Barré syndrome.
<br>
<br> - A history of malignancy with potential risk for recurrence after curative treatment,
<br> or current diagnosis of or treatment for cancer (exceptions are squamous and basal
<br> cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the
<br> discretion of the investigator).
<br>
<br> - Bleeding disorder considered a contraindication to intramuscular injection or
<br> phlebotomy.
<br>
<br> - Participant with ongoing acute diseases or serious medical conditions which will
<br> interfere with adherence to study requirements, or the evaluation of any study
<br> endpoint. Acute diseases or serious medical conditions include cardiovascular,
<br> pulmonary, hepatic, neurologic, metabolic, renal, psychiatric condition (e.g.
<br> alcoholism, drug abuse, anorexia or severe depression), current severe infections,
<br> autoimmune disease, medical history, physical findings, or laboratory abnormality that
<br> in the investigators' opinion are not in stable condition and participating in the
<br> study could adversely affect the safety of the participant.
<br>
<br> - Participant with previous known SARS-CoV-1 or 2 infection.
<br>
<br> - Participant with a history of hypersensitivity to any vaccine or a history of allergic
<br> disease or reactions likely to be exacerbated by any component of the MVC-COV1901.
<br>
<br> - Body (oral, rectal, or ear) temperature = 38.0°C or acute illness (not including minor
<br> illnesses such as diarrhea or mild upper respiratory tract infection at the discretion
<br> of the investigator) within 2 days before the first dose of study intervention.
<br> | | Covid19 Vaccine | Biological: MVC-COV1901(S protein with adjuvant);Biological: MVC-COV1901(Saline) | Immunogenicity of MVC-COV1901-3;Immunogenicity of MVC-COV1901-2;Immunogenicity of MVC-COV1901-1;Incidence of Adverse Events(AEs) [Safety and Tolerability]→Incidence of Adverse Events(AEs) [Safety and Tolerability];Immunogenicity of MVC-COV1901-1;Immunogenicity of MVC-COV1901-2;Immunogenicity of MVC-COV1901-3 | | | | Yes | False | | |
| → | NCT04953052 | 26 October 2021→15 November 2021 | A Randomized Study to Investigate the Effect of Intravenous Imatinib on the Amount of Oxygen in the Lungs and Blood of Adults With COVID-19 Needing Mechanical Ventilation and Supportive Care. | A Randomized, Double-blind, Multicentre 2-arm, Parallel-group, Placebo-controlled Study to Investigate the Efficacy and Safety of Intravenous Imatinib Mesylate in Reducing the Severity of Hypoxemic Respiratory Failure in Patients With Critical COVID-19 Receiving Standard of Care. | IMPRESS COVID | Exvastat Ltd. | 29/06/2021 | 20210629 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04953052 | Recruiting | No | 18 Years | N/A | All | October 14, 2021→November 2021 | 84 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2 | India | ; | Gary Burgess, MD;Sarah J Fritchley, PhD | | ;clinicaltrials@Exvastat.com | ;07944371590 | Exvastat Ltd.; |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female patients aged =18 years
<br>
<br> 2. Women of childbearing potential must have a negative serum pregnancy test to confirm
<br> eligibility
<br>
<br> 3. Provision of signed written informed consent from the patient or patient's legally
<br> acceptable representative
<br>
<br> 4. SARS-CoV-2 infection confirmed by RT-PCR laboratory test (which may include results
<br> from a test that was performed prior to hospital admission if, in the opinion of the
<br> Investigator, it is relevant to ongoing COVID-19)
<br>
<br> 5. Meet Berlin definition for moderate - severe ARDS
<br>
<br> 1. Bilateral opacities - not fully explained by effusions, lobar/lung collapse, or
<br> nodules
<br>
<br> 2. Respiratory failure not fully explained by cardiac failure or fluid overload.
<br>
<br> 3. PaO2/FIO2 =200 mmHg with PEEP =5 cmH2O
<br>
<br> 6. Patient requires intubation or is currently intubated and has been for =48 hours
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Persistent septic shock (>24 hours) with a Mean Arterial Pressure (MAP) =65 mm Hg and
<br> serum lactate level >4 mmol/L (36 mg/dL) despite adequate volume resuscitation and
<br> vasopressor use (norepinephrine >0.2 µg/kg/min) for >6 hours
<br>
<br> 2. Major trauma in the past 5 days
<br>
<br> 3. Presence of any active malignancy (other than non-melanoma skin cancer) that required
<br> treatment within the last year
<br>
<br> 4. Pre-existing severe cardiopulmonary disease including, but not limited to,
<br> interstitial lung disease; severe COPD (GOLD Stage IV or FEV1<30% predicted); heart
<br> failure (estimated left ventricular ejection fraction < 40%); or a chronic lung
<br> condition requiring home oxygen treatment
<br>
<br> 5. An underlying clinical condition that, in the opinion of the Investigator, would make
<br> it very unlikely for the patient to be successfully weaned from ventilation due to
<br> severe underlying diseases (e.g., severe malnutrition, severe neurological disease)
<br>
<br> 6. Patients considered inappropriate for critical care (e.g., being considered for
<br> palliative care)
<br>
<br> 7. Currently receiving extracorporeal membrane oxygenation (ECMO)
<br>
<br> 8. Severe chronic liver disease with Child-Pugh score >12 (Appendix 1)
<br>
<br> 9. White blood count <2.5 x 109/L; Hemoglobin <4.0 mmol/L (6.5g/dL); Platelets <50 x
<br> 109/L
<br>
<br> 10. ALT or AST >10x upper limit of normal (ULN) or bilirubin >3x ULN
<br>
<br> 11. Women who are pregnant or breast-feeding
<br>
<br> 12. Use of drugs with strong CYP3A4 induction potential, such as carbamazepine, efavirenz,
<br> enzalutamide, phenobarbital, phenytoin, hypericum, mitotane, nevirapine, primidone,
<br> rifabutin and rifampicin
<br>
<br> 13. Inability of the ICU staff to initiate administration of study treatment within 48
<br> hours of intubation
<br>
<br> 14. Enrolled in a concomitant clinical trial of an investigational medicinal product
<br>
<br> 15. In the opinion of the investigator, progression to death is highly probable,
<br> irrespective of the provision of treatments
<br> | | Acute Respiratory Distress Syndrome;COVID-19 Acute Respiratory Distress Syndrome;Covid19;ARDS;Pulmonary Oedema | Drug: Imatinib Mesylate;Drug: Placebo | Change from baseline in Oxygen Saturation Index (OSI) at Day 10 | | | | Yes | False | | |
| → | NCT04954287 | 27 September 2021→15 November 2021 | Phase 1 Study of Intranasal PIV5-vectored COVID-19 Vaccine Expressing SARS-CoV-2 Spike Protein in Healthy Adults | A Phase 1 Open-Label, Dose-Ranging Trial to Evaluate the Safety and Immunogenicity of Intranasal Parainfluenza Virus Type 5-SARS CoV-2 S Vaccine (CVXGA1) in Healthy Adults Aged 18 to 75 Years | CVXGA1-001 | CyanVac LLC | 30/06/2021 | 20210630 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04954287 | Recruiting | No | 18 Years | 75 Years | All | August 6, 2021 | 80 | Interventional | Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | United States | ; | Paul Spearman, MD;Marinka Tellier | | ;mtellier@cyanvacllc.com | ;(706) 201-7798 | Children's Hospital Medical Center, Cincinnati; |
<br> Inclusion Criteria:
<br>
<br> - Provide informed consent prior to initiation of any trial procedures.
<br>
<br> - Be able to understand and agrees to comply with planned trial procedures and be
<br> available for all trial visits.
<br>
<br> - Agrees to the collection of venous blood per protocol.
<br>
<br> - Healthy male or non-pregnant female, between 18 and 75 years of age (Group 1 and Group
<br> 2 = 18 to 55 years cohort; Group 3 and Group 4 = 56 to 75 years cohort), inclusive at
<br> time of enrollment who are at lower risk of SARS-CoV-2 infection, defined as adults
<br> whose health status, profession, locations or circumstances put them at lower risk of
<br> exposure to SARS-CoV-2 and COVID-19.
<br>
<br> - Body Mass Index (BMI) <35.0 kg/m2 at screening.
<br>
<br> - Women of childbearing potential* must agree to use or have practiced true abstinence**
<br> or use at least one acceptable primary form of contraception.***, **** Note: These
<br> criteria are applicable to females in a heterosexual relationship and child-bearing
<br> potential (i.e., the criteria do not apply to subjects in a same sex relationship).
<br>
<br> - Women of childbearing potential must have a negative urine or serum pregnancy test
<br> within 24 hours prior to vaccination.
<br>
<br> - Male subjects of childbearing potential*: use of condoms to ensure effective
<br> contraception with a female partner of childbearing potential from vaccination until
<br> 90 days after vaccination. If barrier methods are to be used, then double barrier
<br> methods of protection are required i.e. male condom with a cap, diaphragm or sponge
<br> with spermicide.
<br>
<br> - Male subjects agree to refrain from sperm donation from the time of vaccination until
<br> 90 days after vaccination.
<br>
<br> - Female subjects agree to refrain from egg donation from time of vaccination until 90
<br> days after vaccination.
<br>
<br> - In good health.
<br>
<br> - Oral temperature of 97.0°F (36.1°C) to less than 100.4° Fahrenheit (37.8° C).
<br>
<br> - Pulse is less than 100 beats per minute.
<br>
<br> - Systolic blood pressure (BP) is 85 to 150 mm Hg, inclusive.
<br>
<br> - Diastolic blood pressure <80 mm Hg, inclusive.
<br>
<br> - Clinical screening laboratory evaluations (WBC, hemoglobin, platelets, alanine
<br> transaminase, aspartate transaminase, creatinine, alkaline phosphatase, total
<br> bilirubin, lipase, prothrombin time and partial thromboplastin time) are within
<br> acceptable normal reference ranges at the clinical laboratory being used.
<br> Alternatively, the clinical laboratory abnormalities grading scale noted in the FDA
<br> Toxicity Grading Scale for Healthy Adult Volunteers enrolled in Preventive Vaccine
<br> Clinical Trials may be used.
<br>
<br> - Must agree to have samples stored for secondary research.
<br>
<br> - Agrees to adhere to pandemic public health guidance on preventing SARS-CoV-2 infection
<br> (e.g. wearing a mask, keeping physically distant, sheltering-in) throughout trial
<br> duration.
<br>
<br> - Must agree to refrain from donating blood or plasma during the trial (outside of this
<br> trial).
<br>
<br> - Seronegative to SARS-CoV-2.
<br>
<br> Exclusion Criteria:
<br>
<br> - Positive pregnancy test either at screening or just prior to vaccine administration.
<br>
<br> - Female subject who is breastfeeding or plans to breastfeed from the time of the
<br> vaccination through 60 days after vaccination.
<br>
<br> - Anyone at high risk of severe COVID-19 disease e.g. those with hypertension,
<br> hyperlipidemia, diabetes mellitus, types 1 and 2, chronic lung disease, etc… per CDC
<br> guidance (<
<br> https://www.cdc.gov/coronavirus/2019-ncov/hcp/clinical-care/underlyingconditions.html>
<br> ) or has any medical disease or condition that, in the opinion of the participating
<br> site PI or appropriate sub-investigator, precludes trial participation.*
<br>
<br> - Presence of self-reported or medically documented significant medical or psychiatric
<br> condition(s).
<br>
<br> - Has an acute illness, as determined by the participating site PI or appropriate
<br> sub-investigator, with or without fever [oral temperature = 38.0° Celsius (100.4°
<br> Fahrenheit)] within 72 hours of vaccination.
<br>
<br> - Has a positive test result for hepatitis B surface antigen, hepatitis C virus
<br> antibody, or human immunodeficiency virus (HIV) types 1 or 2 antibodies at screening.
<br>
<br> - Has participated in another investigational trial involving any investigational
<br> product (unlicensed vaccine, drug, biologic, device, blood product, or medication)
<br> within 60 days, or 5 half-lives, whichever is longer, before vaccine administration.
<br>
<br> - Currently enrolled in or plans to participate in another clinical trial with an
<br> investigational product (unlicensed vaccine, drug, biologic, device, blood product, or
<br> medication) that will be received during the trial-reporting period.
<br>
<br> - Has previously participated in an investigational trial of prophylaxis or treatment
<br> for SARS-CoV-2 infection or COVID-19 disease.
<br>
<br> - Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis,
<br> generalized urticaria, angioedema, other significant reaction) to any previous
<br> licensed or unlicensed vaccines.
<br>
<br> - Chronic use (more than 14 continuous days) of any medications that may be associated
<br> with impaired immune responsiveness
<br>
<br> - Anticipating the need for immunosuppressive treatment within the next 6 months.
<br>
<br> - Received immunoglobulins and/or any blood or blood products within the 4 months before
<br> vaccine administration or at any time during the trial.
<br>
<br> - Has any blood dyscrasias or significant disorder of coagulation.
<br>
<br> - Has any chronic liver disease, including fatty liver.
<br>
<br> - Has a history of alcohol abuse or other recreational drug (excluding cannabis) use
<br> within 6 months before vaccine administration.
<br>
<br> - Received or plans to receive a licensed, live vaccine within 4 weeks before or after
<br> vaccination.
<br>
<br> - Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or
<br> after vaccination.
<br>
<br> - Receipt of a COVID19 vaccine.
<br>
<br> - Close contact of anyone known to have SARS-CoV-2 infection within 30 days prior to
<br> vaccine administration.
<br>
<br> - History of COVID-19 diagnosis (positive test for antigen or PCR or antibody).
<br>
<br> - On current treatment with investigational agents for prophylaxis of COVID-19.
<br>
<br> - Plan to travel outside the United States (US) (continental US, Hawaii, and Alaska)
<br> from enrollment through 28 days after vaccination.
<br>
<br> - Reside in a nursing home or other skilled nursing facility or have a requirement for
<br> skilled nursing care.
<br>
<br> - Non-ambulatory.
<br>
<br> - For subjects of any age, individ | | Covid19 | Biological: CVXGA1 low dose;Biological: CVXGA1 high dose | Unsolicited Adverse Events;Solicited Adverse Events | | | | Yes | False | | |
| → | NCT04955587 | 21 July 2021→15 November 2021 | A Longitudinal Study on Longstanding Complicated Fatigue | A Longitudinal Study on Longstanding Complicated Fatigue: Myalgic Encephalomyelitis / Chronic Fatigue Syndrome (ME/CFS), Burnout Syndrome and Post-covid Fatigue | | Stockholm University | 14/06/2021 | 20210614 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04955587 | Not recruiting→Recruiting | No | 18 Years | N/A | All | July 2021→August 24, 2021 | 150 | Observational [Patient Registry] | | | →Sweden | ; → ; ; | Anna Andreasson, A Prof;Anna Andreasson, A Prof→Anna Andreasson, A Prof;Anna Andreasson, A Prof;Martin Jonsjö, PhD | | ;anna.andreasson@su.se→;anna.andreasson@su.se;martin.jonsjo@sll.se | ;+46731505653→;+46731505653; | Stockholm University; |
<br> Inclusion Criteria:
<br>
<br> - Diagnosis set within Stockholm County of ME/CFS, burnout syndrome or
<br> post-COVID-19-syndrome according to the Swedish version of the international
<br> classification of disease (ICD)-10
<br>
<br> - Control group (rheumatic disease): Diagnosis of rheumatoid arthritis
<br>
<br> - Control group (healthy): no diagnosis related to inflammatory disease or fatigue
<br>
<br> Exclusion Criteria:
<br>
<br> - Organic or neuropsychiatric disease that explain the fatigue among cases diagnosed
<br> with ME/CFS, burnout syndrome or post-COVID-19-syndrome according to the Swedish
<br> ICD-10
<br> | | Chronic Fatigue Syndrome;Burnout;Covid19 | | Change in self-reported work ability;Nutritional status;Dietary intake;Change in Inflammatory markers;Change in health related quality of life (World health organization disability assessment scale);Change in Generalized sickness behavior (Sickness questionnaire);Change in symptom burden;Change in fatigue (Multidimensional Fatigue Inventory)→Change in fatigue (Multidimensional Fatigue Inventory);Change in symptom burden;Change in Generalized sickness behavior (Sickness questionnaire);Change in health related quality of life (World health organization disability assessment scale);Change in Inflammatory markers;Dietary intake;Nutritional status;Change in self-reported work ability | | | | Yes | False | | |
| → | NCT04958902 | 26 July 2021→15 November 2021 | RESTORE in Patients Who Had COVID-19 and Close Others | RESTORE: An Online Self-directed Mental Health Intervention for Individuals Who Had COVID-19 and Close Others | | University Health Network, Toronto | 08/07/2021 | 20210708 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04958902 | Not recruiting→Recruiting | No | 18 Years | N/A | All | July 15, 2021→October 22, 2021 | 20 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). | N/A | →Canada | | Kathryn Trottier, PhD | | kathryn.trottier@uhn.ca | 4163404800 | |
<br> Inclusion Criteria:
<br>
<br> - Experienced a traumatic or extremely stressful experience related to being COVID-19+
<br> or having a close other who was COVID-19+
<br>
<br> - Participants who were COVID+ will be eligible once they are no longer exhibiting
<br> COVID-19 symptoms and those who were hospitalized will be eligible post-discharge
<br>
<br> - Close others will be eligible once their close other with COVID-19 has recovered or if
<br> their loved one is deceased
<br>
<br> - = 18 years of age
<br>
<br> - Scores at above clinical threshold on at least one of: Patient Health Questionnaire-9
<br> ([PHQ-9] score = 10), Generalized Anxiety Disorder Scale-7 ([GAD-7] score = 10),
<br> and/or Posttraumatic Stress Disorder Scale-5 ([PCL-5] score = 33)
<br>
<br> - Access to a computer or a tablet with high speed internet access, be able to clearly
<br> see the screen of a computer or tablet, and be fluent in English
<br>
<br> - Ability to provide consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Elevated risk of suicide
<br>
<br> - Currently enrolled in another intervention or treatment (e.g., cognitive behavioural
<br> therapy) for stress responses related to the COVID-19 pandemic
<br> | | Mental Health;PTSD;Anxiety;Depressive Symptoms | Behavioral: RESTORE: Recovering from Extreme Stressors Through Online Resources and E-health | Change in Patient Health Questionnaire-9 (PHQ-9);Change in Generalized Anxiety Disorder-7 (GAD-7);Change in self-reported Post Traumatic Stress Disorder (PTSD) symptoms | | | | Yes | False | | |
| → | NCT04969250 | 1 November 2021→15 November 2021 | Vaccination for Recovered Inpatients With COVID-19 (VATICO) | SARS-CoV-2 Vaccination Strategies in Previously Hospitalized and Recovered COVID-19 Patients | | International Network for Strategic Initiatives in Global HIV Trials (INSIGHT) | 16/07/2021 | 20210716 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04969250 | Recruiting | No | 18 Years | N/A | All | August 25, 2021 | 640 | Interventional | Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 4 | United States;Spain;Uganda;Spain;Uganda;United States | ; | Prof. Jens Lundgren;If interested in participating in this study, please contact the appropriate site or | | ;tico@insight-trials.org | ;send email to | INSIGHT Copenhagen International Coordinating Centre, Rigshospitalet, University of Copenhagen; |
<br> Inclusion Criteria:
<br>
<br> - Participating in (ACTIV-3) TICO trial and received a selected blinded investigational
<br> agent, or placebo for that agent, at selected sites.
<br>
<br> - Willingness to strictly adhere to the randomly allocated dosage number and schedule
<br> for vaccine administration.
<br>
<br> - Participant is between Day 28 and Day 90 TICO visits inclusive at time of
<br> randomization.
<br>
<br> - At time of screening for this study, has experienced sustained recovery for at least
<br> two consecutive weeks, i.e. having return uninterrupted to the person's premorbid
<br> living facility (or equivalent) for at least 2 consecutive weeks.
<br>
<br> - Ability and willingness of participant (or legally authorized representative) to
<br> provide informed consent prior to initiation of any study procedures.
<br>
<br> Exclusion Criteria:
<br>
<br> - Receipt of a SARS-CoV-2 (COVID-19) vaccine after enrollment into TICO. Participants
<br> who received a SARS-CoV-2 vaccine prior to enrollment in TICO may be enrolled in this
<br> study.
<br>
<br> - Known allergy to any component of the study eligible vaccine(s).
<br> | | Covid19 | Biological: Moderna mRNA-1273 COVID-19 vaccine;Biological: Pfizer BNT162b2 COVID-19 vaccine | Neutralizing antibody (NAb) levels following vaccination | | | | Yes | False | | |
| → | NCT04969601 | 2 August 2021→15 November 2021 | Anti-Covid-19 Vaccine in Children With Acute Leukemia and Their Siblings | Anti-Covid-19 Vaccine Protection in Immunocompromised Children (1 to 15 Years Old) With Acute Leukemia and Their Siblings (=12 Years Old). Phase I-II Trial Evaluating Post-vaccine Safety and Humoral and Cellular Immunogenicity. | PACIFIC | Assistance Publique - Hôpitaux de Paris | 19/07/2021 | 20210719 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04969601 | Not recruiting→Recruiting | No | 1 Year | 15 Years | All | August 2021→September 29, 2021 | 150 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1/Phase 2 | France | | Arnaud PETIT, Pr | | arnaud.petit@aphp.fr | +331.71.73.82.57 | |
<br> Inclusion Criteria:
<br>
<br> - Children aged 1 to 15 years old :
<br>
<br> - With acute lymphoblastic leukemia undergoing chemotherapy (at least 2 weeks from
<br> the last injection of PEG-asparaginase) or for whom the last chemotherapy is less
<br> than or equal to 12 months
<br>
<br> - With acute myeloid leukemia within 12 months from the end of treatment
<br>
<br> - Healthy siblings aged 12 to 15 years old living in the same household than the child
<br> with AL more than 50% of the time
<br>
<br> - Informed consent from parents
<br>
<br> - Patient affiliated to health insurance
<br>
<br> Exclusion Criteria:
<br>
<br> - Documented SARS-CoV-2 infection ongoing or that occurred less than 3 months ago
<br>
<br> - Known clinical allergy to polyethylene glycol (PEG)
<br>
<br> - Pregnant woman during first pregnancy quarter or lactating woman
<br>
<br> - Platelet <50 Giga(G) G/L or neutrophils <0.5 G/L at time of vaccination
<br>
<br> - Vaccination within 4 weeks from the 1st injection or planning to receive an approved
<br> vaccine 4 weeks after the last injection
<br>
<br> - Any hemorrhagic trouble considered as a contraindication to intramuscular injection
<br>
<br> - History of severe adverse event after a vaccine administration including anaphylaxis
<br> and associated symptoms such as rash, respiratory issues, angioedema and abdominal
<br> pain, or history of allergic reaction that could be exacerbated by a vaccine component
<br>
<br> - Participant vaccinated against tuberculosis within the past year
<br> | | Acute Leukemia;Acute Lymphoblastic Leukemia;Acute Myeloid Leukemia | Biological: vaccine COMIRNATY® (BNT162b2) | co-primary endpoint: Increase in anti-Spike Immunoglobulin G (IgG) titer AND positive anti-Spike neutralizing test;Dose limiting toxicity (DLT)→Dose limiting toxicity (DLT);co-primary endpoint: Increase in anti-Spike Immunoglobulin G (IgG) titer AND positive anti-Spike neutralizing test | | | | Yes | False | | |
| → | NCT04977024 | 20 September 2021→15 November 2021 | SARS-CoV-2 Vaccine (COH04S1) Versus Emergency Use Authorization SARS-COV-2 Vaccine for the Treatment of COVID-19 in Patients With Blood Cancer | A Multi-Center, Observer-Blinded, EUA Vaccine-Controlled, Randomized Phase II Study to Evaluate the Biological Activity of COH04S1 (SARS-CoV-2 Vaccine) Compared to EUA SARS-CoV-2 Vaccines in Hematology Patients Who Have Received Cellular Therapy (HCT or CAR-T) | | City of Hope Medical Center | 11/06/2021 | 20210611 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04977024 | Recruiting | No | 18 Years | N/A | All | October 1, 2021→September 27, 2021 | 240 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2 | United States | ; | Sanjeet S Dadwal;Sanjeet S. Dadwal | | ;sdadwal@coh.org | ;626-218-8202 | City of Hope Medical Center |
<br> Inclusion Criteria:
<br>
<br> - Documented informed consent of the participant
<br>
<br> - Age >=18 years
<br>
<br> - Eastern Cooperative Oncology Group (ECOG) =< 2
<br>
<br> - Allogeneic or autologous hematopoietic cell transplant (HCT), cellular therapy
<br> (chimeric antigen receptor [CAR] T-cell) recipients who are at >= 3 months of infusion
<br> date of respective regimen
<br>
<br> - Platelets >= 50,000/mm^3 (to be performed within 30 days prior to day 0 of protocol
<br> therapy unless otherwise stated)
<br>
<br> - White blood cells (WBCs) >= 1000/mm^3 (to be performed within 30 days prior to day 0
<br> of protocol therapy unless otherwise stated)
<br>
<br> - Total bilirubin < 1.5 X upper limit of normal (ULN) (to be performed within 30 days
<br> prior to day 0 of protocol therapy unless otherwise stated)
<br>
<br> - Aspartate aminotransferase (AST) < 2.5 X ULN (to be performed within 30 days prior to
<br> day 0 of protocol therapy unless otherwise stated)
<br>
<br> - Alanine aminotransferase (ALT) < 2.5 X ULN (to be performed within 30 days prior to
<br> day 0 of protocol therapy unless otherwise stated)
<br>
<br> - Creatinine < 1.5 X ULN (to be performed within 30 days prior to day 0 of protocol
<br> therapy unless otherwise stated)
<br>
<br> - Women of childbearing potential (WOCBP): negative urine or serum pregnancy test (to be
<br> performed within 30 days prior to day 0 of protocol therapy unless otherwise stated).
<br> If the urine pregnancy test is inconclusive a serum pregnancy test will be required
<br>
<br> - Agreement by females and males of childbearing potential* to use an effective method
<br> of birth control or abstain from heterosexual activity for the course of the study
<br> through at least 6 weeks after the last dose of protocol therapy
<br>
<br> - Childbearing potential defined as not being surgically sterilized (men and women)
<br> or have not been free from menses for > 1 year (women only)
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who have received second allogeneic HCT are not eligible (patients who have
<br> undergone a previous autologous HCT are eligible
<br>
<br> - Systemic corticosteroids required for chronic conditions at doses > 0.5mg/kg/day
<br> prednisone equivalent
<br>
<br> - Patients on maintenance therapies (e.g. rituximab, Bruton tyrosine kinase inhibitors,
<br> Janus kinase inhibitors), who may have significantly attenuated response to
<br> vaccination
<br>
<br> - Subjects using investigational or licensed agents that may prevent or treat SARS-CoV-2
<br> are excluded such as any previous SARS-CoV-2 vaccine
<br>
<br> - Subjects who have had a live vaccine =30 days prior to administration of study vaccine
<br> or subjects who are =< 2 weeks within administration of inactivated vaccines (e.g.
<br> influenza vaccine). Flu shots are allowed > 2 weeks before the first injection and > 2
<br> weeks post 2nd injection
<br>
<br> - History of allergic reactions attributed to compounds of similar chemical or biologic
<br> composition to vaccine agents
<br>
<br> - History of adverse event with a prior smallpox vaccination
<br>
<br> - Any MVA vaccine or poxvirus vaccine in the last 12 months
<br>
<br> - Clinically significant uncontrolled illness
<br>
<br> - Females only: Pregnant or breastfeeding
<br>
<br> - Any other condition that would, in the Investigator's judgment, contraindicate the
<br> subject's participation in the clinical study due to safety concerns with clinical
<br> study procedures
<br>
<br> - Prospective participants who, in the opinion of the investigator, may not be able to
<br> comply with all study procedures (including compliance issues related to
<br> feasibility/logistics)
<br>
<br> - Anyone considered to be in a vulnerable population
<br> | | COVID-19 Infection;Hematopoietic and Lymphoid System Neoplasm;Leukemia;Lymphoma;Plasma Cell Myeloma | Biological: COVID-19 Vaccine;Other: Diagnostic Laboratory Biomarker Analysis;Biological: Synthetic MVA-based SARS-CoV-2 Vaccine COH04S1 | Biological response | | | | Yes | False | | |
| → | NCT04979949 | 1 November 2021→15 November 2021 | Booster Vaccination Against SARS-CoV-2 | Double-Blind, Randomized, Controlled, Multi-Center Phase 2 Clinical Trial to Determine Safety, Efficacy, and Immunogenicity of Booster Vaccination Against SARS-CoV-2 | | Health Institutes of Turkey | 15/07/2021 | 20210715 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04979949 | Recruiting | No | 18 Years | 60 Years | All | July 12, 2021 | 222 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2 | Turkey | ; | Ahmet Omma, Assoc. Prof.;Ahmet Omma, Assoc. Prof. | | ;ahmetomma@hotmail.com | ;+90 (312) 552 60 00 | Faculty Member; |
<br> Inclusion Criteria:
<br>
<br> - Signed informed consent
<br>
<br> - Healthy male or female aged 18 - 60 years (including both groups)
<br>
<br> - Subjects who were vaccinated with CoronaVac for 2 doses and who had a minimum of 90
<br> days and a maximum of 270 days after the second dose
<br>
<br> - Subjects may have a controlled or moderate comorbidity
<br>
<br> - Female subjects of childbearing potential should be willing to ensure that they or
<br> their partner use effective birth control methods continuously from 1 month before and
<br> up to 3 months after vaccination
<br>
<br> - Subjects agreed to comply with all study requirements
<br>
<br> - Subjects are willing to share their medical history with their physician and allow
<br> access to all medical records when relevant to study procedures
<br>
<br> - Subjects are willing to agree to abstain from donating blood during the study
<br>
<br> Exclusion Criteria:
<br>
<br> Subjects meeting any of the following criteria will be excluded from the study:
<br>
<br> - Receipt of any vaccine (registered or investigational) other than study intervention
<br> within 30 days before and after each study vaccine (one week for authorized seasonal
<br> flu vaccine or pneumococcal vaccine)
<br>
<br> - Positive for COVID-19 after primary vaccination
<br>
<br> - Pre-or planned use of another vaccine or product likely to affect the study (e.g.
<br> adenovirus vectored vaccines, any coronavirus vaccine)
<br>
<br> - Subjects who were pregnant at the time of enrollment or who plan to become pregnant
<br> within the first 3 months following vaccination and who are breastfeeding
<br>
<br> - Subjects with fever (above 38°C) at the time of vaccination and/or up to 72 hours
<br> before
<br>
<br> - Administration of immunoglobulins and/or any blood product within 3 months prior to
<br> vaccination
<br>
<br> - Any confirmed or suspected immunosuppressive or immunodeficiency state; asplenia;
<br> recurrent severe infections and use of immunosuppressants (less than =14 days) in the
<br> last 6 months, excluding topical steroids or short-term oral steroids
<br>
<br> - Possible history of allergic disease or reaction (eg to the active substance) by any
<br> component of the study vaccines
<br>
<br> - Any history of anaphylaxis
<br>
<br> - Current cancer diagnosis or treatment (excluding basal cell carcinoma of the skin and
<br> cervical carcinoma in situ)
<br>
<br> - History of bleeding disorder (e.g. factor deficiency, coagulopathy or platelet
<br> disorder), or prior history of significant bleeding or bruising following
<br> intramuscular injections or venipuncture
<br>
<br> - Continued use of anticoagulants such as coumarins and related anticoagulants (ie
<br> warfarin) or new oral anticoagulants (ie apixaban, rivaroxaban, dabigatran and
<br> edoxaban)
<br>
<br> - Cerebral venous sinus thrombosis, antiphospholipid syndrome, or a history of
<br> heparin-induced thrombocytopenia and thrombosis (HITT or HIT type 2).
<br>
<br> - Suspected or known current alcohol or drug addiction
<br>
<br> - Any other significant disease, disorder or finding that could significantly increase
<br> the subject's risk for participation in the study, affect the subject's ability to
<br> participate in the study, or impair the interpretation of study data; severe and/or
<br> uncontrolled cardiovascular disease, respiratory disease, gastrointestinal disease,
<br> liver disease, kidney disease, endocrine disorder, and neurological disease
<br> (mild/moderate well-controlled comorbidities are permitted)
<br>
<br> - History of active or previous autoimmune neurological disorders (eg multiple
<br> sclerosis, Guillain-Barre syndrome, transverse myelitis) (Bell's palsy will not be an
<br> exclusion criterion)
<br>
<br> - Subjects with severe renal impairment or liver failure
<br>
<br> - Subjects who will undergo scheduled elective surgery during the study
<br>
<br> - Subjects with a life expectancy of less than 6 months
<br>
<br> - Subject who participated in another clinical trial study involving an investigational
<br> product in the past 12 weeks
<br>
<br> - In case of clinical necessity, a COVID-19 PCR (polymerase chain reaction) test will be
<br> requested from the subjects, and subjects who are positive will be excluded from the
<br> study
<br>
<br> - Known history of SARS-CoV-2 infection
<br>
<br> - Acute respiratory disease (moderate or severe illness with or without fever) (Subjects
<br> may be screened again after acute condition has resolved)
<br>
<br> - Fever (oral temperature > 37.8°C) (Subjects can be enroll again after acute condition
<br> improves)
<br>
<br> - Insufficient level of Turkish to perform the informed consent, except where briefing
<br> by an independent witness can be provided and is available
<br> | | COVID-19;Sars-CoV-2 Infection | Biological: CoronaVac;Biological: CoronaVac→Biological: CoronaVac;Biological: Turkovac | Incidence of Serious Adverse Events (SAE);Incidence of adverse reactions | | | | Yes | False | | |
| → | NCT04988035 | 1 November 2021→15 November 2021 | ACTIV-5 / Big Effect Trial (BET-C) for the Treatment of COVID-19 | A Multicenter Platform Trial of Putative Therapeutics for the Treatment of COVID-19 in Hospitalized Adults | | National Institute of Allergy and Infectious Diseases (NIAID) | 29/07/2021 | 20210729 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04988035 | Recruiting | No | N/A | N/A | All | July 21, 2021 | 200 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2 | United States | | 20-0013 Central Contact | | DMIDClinicalTrials@niaid.nih.gov | 13017617948 | |
<br> Inclusion Criteria:
<br>
<br> 1. Admitted to a hospital with symptoms suggestive of COVID-19 and requires ongoing
<br> medical care.
<br>
<br> 2. Subject (or legally authorized representative) provides informed consent prior to
<br> initiation of any study procedures.
<br>
<br> 3. Subject (or legally authorized representative) understands and agrees to comply with
<br> planned study procedures.
<br>
<br> 4. Male or non-pregnant female adult >/=18 years of age at time of enrollment.
<br>
<br> 5. Illness of any duration and has laboratory-confirmed SARS-CoV-2 infection as
<br> determined by polymerase chain reaction (PCR) or other commercial or public health
<br> assay (e.g., Nucleic Acid Amplification Test [NAAT], antigen test) in any respiratory
<br> specimen or saliva </=14 days prior to randomization.
<br>
<br> 6. Illness of any duration, and requiring, just prior to randomization, supplemental
<br> oxygen (any flow), mechanical ventilation or extracorporeal membrane oxygenation
<br> (ECMO) (ordinal scale category 5, 6, or 7).
<br>
<br> 7. Women of childbearing potential and men must agree to either abstinence or use at
<br> least one acceptable method of contraception* from the time of screening through 30
<br> days after the last dose of danicopan for women and 90 days after the last dose for
<br> men.
<br>
<br> *Acceptable methods include barrier contraceptives (condoms or diaphragm) with
<br> spermicide, intrauterine devices (IUDs), hormonal contraceptives, oral contraceptive
<br> pills, and surgical sterilization.
<br>
<br> 8. Agrees not to participate in another blinded clinical trial (both pharmacologic and
<br> other types of interventions) for the treatment of COVID-19 through Day 29
<br>
<br> Exclusion Criteria:
<br>
<br> 1. aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 times the upper
<br> limit of normal.
<br>
<br> 2. Subjects with a low glomerular filtration rate (eGFR), specifically:
<br>
<br> 1. Subjects with an eGFR 15-30 mL/min are excluded unless in the opinion of the
<br> principal investigator (PI), the potential benefit of participation outweighs the
<br> potential risk of study participation.
<br>
<br> 2. All subjects with an eGFR <15 mL/min (including hemodialysis and hemofiltration)
<br> are excluded.
<br>
<br> 3. Pregnancy or breast feeding
<br>
<br> 4. Anticipated discharge from the hospital or transfer to another hospital which is not a
<br> study site within 72 hours of enrollment.
<br>
<br> 5. Allergy to any study medication.
<br>
<br> 6. Received five or more doses of remdesivir prior to screening.
<br>
<br> 7. Treatment with a complement inhibitor in the prior 8 weeks.*
<br>
<br> 8. Has active uncontrolled opportunistic infection, or uncontrolled cirrhosis.*
<br>
<br> 9. History of infection with N. meningitidis.*
<br>
<br> 10. Known history of hypersensitivity to danicopan or its excipients.*
<br>
<br> 11. Has a medical condition that could, in the judgment of the investigator, limit the
<br> interpretation and generalizability of trial results.
<br>
<br> 12. Positive test for influenza virus during the current illness (influenza testing is not
<br> required by protocol).
<br>
<br> 13. History of liver cirrhosis.*
<br>
<br> 14. Previous participation in an ACTIV-5/BET trial.
<br>
<br> 15. Refuses to refrain from breastfeeding from the time of screening through 30 days after
<br> the last dose of danicopan.*
<br>
<br> 16. Refuses to receive prophylactic antibiotics against meningococcal infections if the
<br> subject has not been vaccinated in the 3 years prior to Study Day 1.
<br> | | COVID-19 | Drug: Danicopan;Other: Placebo;Drug: Remdesivir | Clinical status on an 8-point ordinal scale. | | | | Yes | False | | |
| → | NCT04991467 | 18 October 2021→15 November 2021 | Multimodal CARES Intervention | A Multimodal Parent-focused Intervention for Vulnerable Populations in the Bronx | CARE | Albert Einstein College of Medicine | 16/07/2021 | 20210716 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04991467 | Not recruiting | No | 18 Years | 65 Years | All | October 2021→December 2021 | 360 | Interventional | Allocation: Randomized. Intervention model: Factorial Assignment. Primary purpose: Other. Masking: None (Open Label). | N/A | | ; | Vilma Gabbay, MD;Jennifer Alexander, BA | | ;jealexan@montefiore.org | ;929-429-5644 | Albert Einstein College of Medicine; |
<br> Inclusion Criteria:
<br>
<br> - All participants will be primary caregivers who present with moderate level of stress
<br> by meeting a severity score of = 14 on the Perceived Stress Scale (PSS22).
<br>
<br> - Investigators will allow primary caregivers (e.g., grandmothers and aunts) as it is
<br> common in our patient population.
<br>
<br> - Clinical cohorts will be active patients in the psychiatric and rheumatology clinics
<br> in Montefiore Medical Center (MMC).
<br>
<br> - Frontline health care providers will be those who are required to work on site at
<br> Montefiore Medical Center (MMC).
<br>
<br> Exclusion Criteria:
<br>
<br> - Serious psychiatric or substance use difficulty that, in the judgement of the PI,
<br> would preclude meaningful participation in a parent intervention.
<br>
<br> - Active child abuse/maltreatment cases.
<br>
<br> - Neurocognitive conditions that may prevent participants from accessing telehealth
<br> services.
<br>
<br> - Primary language other than Spanish or English.
<br>
<br> - Utilized a smartphone health platform similar to the Valera app.
<br> | | Parenting;Covid19 | Behavioral: CARE Program and Valera Application with care manager functionality;Behavioral: Valera Application with care manager functionality;Behavioral: CARE Program;Behavioral: Valera Application;Behavioral: CARE Program and Valera Application | Perceived Stress;Perceived Stress;Perceived Stress;Perceived Stress | | | | Yes | False | | |
| → | NCT04992234 | 11 October 2021→15 November 2021 | COVID-19 Antibody Responses in Cystic Fibrosis | COVID-19 Antibody Responses in Cystic Fibrosis:CAR-CF | CAR-CF | Vastra Gotaland Region | 03/08/2021 | 20210803 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT04992234 | Recruiting | No | N/A | N/A | All | August 31, 2021 | 150 | Observational | | | Sweden | ; | Marita Gilljam;Marita Gilljam | | ;marita.gilljam@vgregion.se | ;+46313421000 | Sahlgrenska University Hospital, Sweden; |
<br> Inclusion Criteria:
<br>
<br> Consenting people with cystic fibrosis of any age, genotype, transplant status and disease
<br> severity will be eligible to participate in the study. The study population is expected to
<br> be representative of the general CF population.
<br>
<br> Exclusion Criteria:
<br>
<br> There are no specific exclusion criteria other than refusal to give informed consent, or
<br> contraindication to venepuncture.
<br>
<br> Participants already enrolled in a clinical trial are eligible for enrolment in this study.
<br> Inclusion in CAR-CF should not preclude enrolment in other observational clinical trial
<br> studies or clinical trials of an investigational medicinal product (CTIMP).
<br> | | Cystic Fibrosis;Covid19 | | To perform a longitudinal comparison;To examine the associations;To evaluate SARS-CoV-2 seroprevalence→To evaluate SARS-CoV-2 seroprevalence;To examine the associations;To perform a longitudinal comparison | | | | Yes | False | | |
| → | NCT05000346 | 24 August 2021→15 November 2021 | Clinical Trial to Assess the Efficacy and Safety of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms | A Randomized, Double-blind, Placebo-controlled, Parallel, Trial to Determine the Safety and Efficacy of Inhaled AQ001S in the Management of Acute COVID-19 Symptoms | SIROCCO-1 | Aquilon Pharmaceuticals S.A. | 24/06/2021 | 20210624 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05000346 | Not recruiting | No | 18 Years | N/A | All | August 2021→November 2021 | 99 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | Belgium | ; ; | Julien Guiot, MD;Maurizio Passanisi;Julien Guiot, MD | | ;mpassanisi@aquilonpharma.com; | ;+3242292809; | CHU Liege; |
<br> Inclusion Criteria:
<br>
<br> 1. Patient admitted to hospital due to the severity of his/her confirmed or suspected
<br> COVID-19 disease.
<br>
<br> 2. Positive virus test for Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
<br> using real time polymerase chain reaction (nasal swab).
<br>
<br> 3. Patient with COVID-19 clinical progression scale score = 4 (hospitalized; no oxygen
<br> therapy).
<br>
<br> 4. Male or female, =18 years of age at the time of consent.
<br>
<br> 5. Patients who have given written informed consent.
<br>
<br> 6. Reliable patients who are willing to be available for the duration of the clinical
<br> trial and willing to comply with clinical trial procedures.
<br>
<br> 7. Patients who have the ability to understand the requirements of the clinical trial.
<br>
<br> 8. Female patients of childbearing potential (women of childbearing potential, WOCBP )
<br> should have a negative pregnancy test at Screening Visit.
<br>
<br> 9. Female patients of childbearing potential (women of childbearing potential, WOCBP1)
<br> using a highly effective method of contraception (i.e., pregnancy rate of < 1% per
<br> year) on a stable regimen, for at least 28 days, and pursuing this contraception
<br> during the trial and for 28 days after the last administration of the study drug The
<br> highly effective methods of contraception must be one of the following: combined
<br> estrogen and progestogen hormonal contraception with inhibition of ovulation,
<br> progestogen-only hormonal contraception associated with inhibition of ovulation,
<br> intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion,
<br> vasectomized partner, or agreement on continuous abstinence from heterosexual
<br> intercourse.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Intensive care patients
<br>
<br> 2. Inability to use a nebulizer with a mouthpiece.
<br>
<br> 3. History of hypersensitivity to corticosteroid or to any of the excipients in the drug
<br> preparation.
<br>
<br> 4. Untreated oral candidiasis.
<br>
<br> 5. Evidence of symptomatic chronic or acute respiratory infection other than COVID-19 in
<br> the previous 8 weeks.
<br>
<br> 6. Proven diagnosis of Chronic Obstructive Pulmonary Disease, asthma or bronchiectasis.
<br>
<br> 7. Pulmonary malformations, tuberculosis, cystic fibrosis.
<br>
<br> 8. History or presence of severe renal (stage 4 (GFR = 15-29 mL/min)) and/or severe
<br> hepatic impairment(s) (grade 4 or above)
<br>
<br> 9. Anticipated transfer to another hospital within 72 hours.
<br>
<br> 10. Use of inhaled corticosteroid, at a strength at least equivalent to 200 µg of
<br> beclomethasone per day, within 7 days before Screening Visit.
<br>
<br> 11. Systemic corticosteroids (e.g., dexamethasone) within 28 days before Screening Visit.
<br>
<br> 12. Female patients who are breast-feeding, lactating, pregnant or intending to become
<br> pregnant.
<br>
<br> 13. Any condition, including findings in the patients' medical history or in the
<br> pre-randomization study assessments that, in the opinion of the Investigator,
<br> constitute a risk or a contraindication for the participation of the patient into the
<br> study or that could interfere with the study objectives, conduct or evaluation.
<br>
<br> 14. Current or previous participation in another clinical trial where the patient has
<br> received a dose of an study drug containing small molecules within 30 days or 5
<br> half-lives (whichever is longer) prior to entry into this study or containing
<br> biologicals within 3 months prior to entry into this study
<br> | | Covid19 | Drug: Drug, inhalation | Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability];WHO clinical progression scale (COVID-19 clinical progression scale)→WHO clinical progression scale (COVID-19 clinical progression scale);Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | | | | Yes | False | | |
| → | NCT05002530 | 27 September 2021→15 November 2021 | Investigating the Potential Role of Aerosolized All-trans Retinoic Acid for Treating COVID-19 Anosmia and Regaining Sense of Smell.→Investigating the Potential Role of Aerosolized Retinoic Acid, a Potent Vitamin A Metabolite for Treating COVID-19 Anosmia and Retinoic Acid Insufficiency .A Novel Approach for Regaining Sense of Smell. | Investigating the Potential Role of Aerosolized All-trans Retinoic Acid for Treating COVID-19 Anosmia and Regaining Sense of Smell.→Investigating the Potential Role of Aerosolized Retinoic Acid, a Potent Vitamin A Metabolite for Treating COVID-19 Anosmia and Retinoic Acid Insufficiency .A Novel Approach for Regaining Sense of Smell. | | Amr kamel khalil Ahmed→Kafrelsheikh University | 10/08/2021 | 20210810 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05002530 | Not recruiting | No | 18 Years | 70 Years | All | November 2021 | 1000→10000 | Interventional | Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). →Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 4 | Saudi Arabia→United States;Saudi Arabia;Egypt;China;Saudi Arabia;Egypt;China | ; ; | Amr Ahmed;Mahmoud Elkazzaz;Amr Ahmed→Tamer Haydara, Ass/Prof of Internal medicine;Mahmoud Elkazzaz, M.Sc of Biochemistry;Mahmoud R Mahmoud, M.Sc of Biochemistry | | ;;drmedahmed@gmail.com→;;mahmoudramadan2051@yahoo.com | ;;00966597310032→;;+201090302015 | Ministry of Health;Damietta University;→Faculty of Medicine Kafrelshiekh university;Faculty of Science, Damietta university; |
<br> Inclusion Criteria:
<br>
<br> - adults 18 yrs or older patients
<br>
<br> - confirmed case (+ve PCR),
<br>
<br> - recovered/discharged (2 -ve PCR),
<br>
<br> - suffered from sudden recent anosmia or hyposmia
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients <18 years of age Patients who are unable to provide informed consent
<br>
<br> - anosmia improved before COVID19 recovery,
<br>
<br> - pregnancy
<br>
<br> - patients who will not complete the follow up period.
<br>
<br> - Patients without a positive COVID-19 PCR result obtained through nasopharyngeal --swab
<br> - Patients with a COVID-19 diagnosis but without self-reported anosmia --Patients with
<br> severe COVID-19 disease as defined by the Mouth Sinai Health System --Treatment
<br> Guidelines for SARS-COV-2 (requiring high flow nasal cannula, non-rebreather,
<br> CPAP/BIPAP, or mechanical ventilation OR patients requiring pressor medication OR
<br> -----
<br>
<br> - patients with evidence of end organ damage)
<br>
<br> - Patients with pre-existing self-reported olfactory dysfunction
<br>
<br> - Patients with a history of chronic nasal/sinus infections (rhinosinusitis) or history
<br> of endoscopic sinus surgery
<br>
<br> - Hypercholesterolemia
<br>
<br> - Hypertriglyceridemia
<br>
<br> - Patients using nasal steroid sprays or irrigations for any reason
<br>
<br> - Patients who are prisoners of the state
<br>
<br> - Patients who have psychiatric or developmental disorder conditions that may impair
<br> ability to provide informed consent
<br>
<br> - Permanent blindness in one eye
<br>
<br> - History of iritis, endophthalmitis, scleral inflammation or retinitis 15-90 days of
<br> retinal detachment or eye surgery
<br>
<br> - The competent physician considered it inappropriate to participate in the study
<br> | | Post COVID-19 Anosmia (Loss of Smell) | Drug: Aerosolized All trans retinoic acid;Drug: Placebo/Control→Drug: Aerosolized 13 cis retinoic acid plus Vitamin D;Drug: Aerosolized All trans retinoic acid plus Vitamin D;Other: Standard therapy | Improvement of olfaction | | | | Yes | False | | |
| → | NCT05004181 | 18 October 2021→15 November 2021 | Safety and Immunogenicity of a SARS CoV 2 Multivalent RNA Vaccine in Healthy Participants | A Phase II Trial to Evaluate the Safety and Immunogenicity of a SARS CoV 2 Multivalent RNA Vaccine in Healthy Subjects | | BioNTech SE | 05/08/2021 | 20210805 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05004181 | Recruiting | No | 18 Years | 85 Years | All | August 25, 2021 | 1245 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 2 | United States | ; | BioNTech Responsible Person;BioNTech clinical trials patient information | | ;patients@biontech.de | ;+49 6131 9084 | BioNTech SE; |
<br> Inclusion Criteria:
<br>
<br> - Have given informed consent by signing the informed consent form (ICF) before
<br> initiation of any trial-specific procedures.
<br>
<br> - Volunteers who at the time of consent are:
<br>
<br> - Part A: 18 to 55 years old.
<br>
<br> - Part B: 18 to 85 years old (~60% should be 18 to 55 years old and ~40% 56 to 85 years
<br> old).
<br>
<br> - For Cohorts 1 to 5: Have received BNT162b2 vaccine (30 µg, two-dose regimen) in either
<br> a clinical trial or as part of the governmental vaccination programs at least 6 months
<br> before Visit 0. Participants who are currently enrolled in the Phase III BNT162-02 /
<br> C4591001 trial, have already been unblinded, and have previously received two doses of
<br> BNT162b2 at least 6 months earlier can be included. At enrollment into Part B of this
<br> trial, their participation in the BNT162-02 / C4591001 trial will be terminated.
<br> Participants should have not experienced COVID-19 based on medical history.
<br>
<br> - For Cohort 6: Are COVID-19 vaccine-naïve and have not experienced COVID-19 based on
<br> their medical history.
<br>
<br> - Are willing and able to comply with all scheduled visits, vaccination plan, laboratory
<br> tests, lifestyle considerations, and other trial procedures.
<br>
<br> - Are overall healthy at Visit 0 in the clinical judgment of the investigator based on
<br> the medical history, clinical assessment (including physical examination, vital signs,
<br> blood and urine clinical laboratory tests, 12-lead electrocardiogram (ECG), and oral
<br> swab for Nucleic Acid Amplification-based Test (NAAT)-based Severe Acute Respiratory
<br> Syndrome Coronavirus 2 (SARS-CoV-2) testing).
<br>
<br> Note: Healthy volunteers with pre-existing stable disease, defined as disease not requiring
<br> significant change in therapy or hospitalization for worsening disease during the 12 weeks
<br> before Visit 0, can be included.
<br>
<br> Note: Volunteers who had hepatitis C (HCV) infection, but have completed curative treatment
<br> based on the medical history can be included. Volunteers who had or have hepatitis B (HBV)
<br> or human immunodeficiency virus (HIV) based on the medical history cannot be included.
<br>
<br> - Agree not to enroll in another trial of an Investigational Medicinal Product (IMP),
<br> starting after Visit 0 and continuously until the last planned visit in this trial.
<br>
<br> - Women of childbearing potential (WOCBP) must test negative in a urine beta-human
<br> chorionic gonadotropin (ß-HCG) test at Visits 0 and 1.
<br>
<br> - WOCBP must agree to practice a highly effective form of contraception starting at
<br> Visit 0 and continuously until 28 days after their last IMP administration in this
<br> trial.
<br>
<br> - WOCBP must confirm that they practiced an acceptable form of contraception for the 14
<br> days prior to Visit 0.
<br>
<br> - WOCBP must agree not to donate eggs (ova, oocytes) for the purposes of assisted
<br> reproduction starting after Visit 0 and continuously until 28 days after their last
<br> IMP injection in this trial.
<br>
<br> - Men who are sexually active with a WOCBP and have not had a vasectomy must agree to
<br> use a highly effective form of contraception with their female partner of childbearing
<br> potential starting after Visit 0 and continuously until 28 days after their last IMP
<br> injection in this trial.
<br>
<br> - Men must be willing to refrain from sperm donation, starting after Visit 0 and
<br> continuously until 28 days after their last vaccination.
<br>
<br> Exclusion Criteria:
<br>
<br> - Any existing condition which may affect vaccine injection and/or assessment of local
<br> reactions assessment, e.g., tattoos, severe scars, etc.
<br>
<br> - Any bleeding diathesis or condition associated with prolonged bleeding that would, in
<br> the opinion of the investigator, contraindicate intramuscular injection.
<br>
<br> - Any medical or psychiatric condition including recent (within the past year) or active
<br> suicidal ideation/behavior or laboratory abnormality that, in the investigator's
<br> judgment, make the participant inappropriate for the trial.
<br>
<br> - Any current febrile illness (body temperature =38.0°C/=100.4°F) or other acute illness
<br> within 48 h prior to Day 1/IMP injection in this trial.
<br>
<br> - Any current or history of cardiovascular diseases, e.g., myocarditis, pericarditis,
<br> myocardial infarction, congestive heart failure, cardiomyopathy or clinically
<br> significant arrhythmias.
<br>
<br> - History of COVID-19 and/or clinical (based on COVID-19 symptoms/signs alone, if a SARS
<br> CoV 2 NAAT result was not available) or microbiological (based on COVID-19
<br> symptoms/signs and a positive SARS CoV 2 NAAT result) evidence of prior infection with
<br> SARS CoV 2 at screening (Visit 0).
<br>
<br> - History of Guillain-Barré syndrome.
<br>
<br> - Known or suspected immunodeficiency.
<br>
<br> - History of severe adverse reaction associated with a vaccine and/or severe allergic
<br> reaction (e.g., anaphylaxis) to any component of the trial IMPs.
<br>
<br> - History or known allergy, hypersensitivity, or intolerance to the trial IMP including
<br> any excipients of the IMPs in this trial.
<br>
<br> - Have received any SARS CoV 2 vaccination other than BNT162b2 (30 µg BNT162b2 given as
<br> a course of two doses at least 21 days apart).
<br>
<br> - Have received a live or live attenuated vaccine within 28 days prior to Day 1/IMP
<br> injection.
<br>
<br> - Have received any other vaccines within 14 days before or after any IMP injection,
<br> e.g., influenza, tetanus, pneumococcal, hepatitis A or B. When possible standard or
<br> care vaccinations should be planned with the trial IMP administrations in mind.
<br>
<br> - Individuals who receive treatment with radiotherapy or immunosuppressive therapy,
<br> including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids
<br> are administered for =14 days at a dose of =20 mg/day of prednisone or equivalent),
<br> e.g., for cancer or an autoimmune disease, or planned receipt throughout this trial.
<br> Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes)
<br> corticosteroids are permitted.
<br>
<br> - Receipt of blood/plasma products or immunoglobulin, from 60 days before IMP
<br> administration or planned receipt throughout this trial.
<br>
<br> - Participation in other trials involving IMP within 28 days or 5 half-lives (whichever
<br> is longer) prior to Visit 1 and/or during trial participation, besides participation
<br> in trials with BNT162b2.
<br>
<br> - Are pregnant or breastfeeding or are planning pregnancy during this trial.
<br>
<br> - Are vulnerable individuals as per International Conference on Harmonisation (ICH) E6
<br> definition, i.e., are individuals whose willingness to volunteer in a clinical trial
<br> may be unduly influenced by the expectation, whether justified or not, of be | | SARS-CoV2 Infection;Covid19;SARS-CoV-2 Acute Respiratory Disease;SARS (Disease) | Biological: BNT162b2;Biological: BNT162b2 (B.1.1.7 + B.1.617.2);Biological: BNT162b2 (B.1.1.7);Biological: BNT162b2 (B.1.617.2) | Percentage of participants reporting local reactions at the injection site;Percentage of participants reporting systemic events;Percentage of participants reporting adverse events (AEs);Percentage of participants reporting serious adverse events (SAEs);Part B - Geometric mean ratio (GMR) of B.1.1.7;Part B - GMR of B.1.617.2 NT 1 month after 1 dose of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-experienced participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - GMR of B.1.617.2 NT 1 month after 1 dose of BNT162b2 (B.1.617.2) on BNT162b2-experienced participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - The difference in Seroresponse (SR) to B.1.1.7;Part B - The difference in SR to B.1.617.2;Part B - The difference in SR to B.1.617.2 NT 1 month after 1 dose of BNT162b2 (B.1.617.2) on BNT162b2-experienced participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - GMR of B.1.1.7 NT 1 month after 2 doses of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - GMR of B.1.617.2 NT 1 month after 2 doses of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - The difference in SR to B.1.1.7 NT 1 month after 1 dose of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - The difference in SR to B.1.617.2 NT 1 month after 1 dose of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial→Percentage of participants reporting local reactions at the injection site;Percentage of participants reporting systemic events;Percentage of participants reporting adverse events (AEs);Percentage of participants reporting serious adverse events (SAEs);Part B - The difference in SR to B.1.617.2 NT 1 month after 1 dose of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - The difference in SR to B.1.1.7 NT 1 month after 1 dose of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - GMR of B.1.617.2 NT 1 month after 2 doses of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - GMR of B.1.1.7 NT 1 month after 2 doses of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-naïve participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - The difference in SR to B.1.617.2 NT 1 month after 1 dose of BNT162b2 (B.1.617.2) on BNT162b2-experienced participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - The difference in SR to B.1.617.2;Part B - The difference in Seroresponse (SR) to B.1.1.7;Part B - GMR of B.1.617.2 NT 1 month after 1 dose of BNT162b2 (B.1.617.2) on BNT162b2-experienced participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - GMR of B.1.617.2 NT 1 month after 1 dose of BNT162b2 (B.1.1.7 + B.1.617.2) on BNT162b2-experienced participants to the reference strain NT 1 month after 2 doses of BNT162b2 in participants from the Phase III BNT162-02 / C4591001 trial;Part B - Geometric mean ratio (GMR) of B.1.1.7 | | | | Yes | False | | |
| → | NCT05008991 | 30 August 2021→15 November 2021 | Lung Functions in Menopausal Obese Women After COVID 19 Recovery | Assessment of Lung Functions in Menopausal Obese Women After COVID 19 Recovery | | Badr University | 16/08/2021 | 20210816 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05008991 | Recruiting→Not recruiting | No | 45 Years | 55 Years | Female | July 20, 2021 | 40 | Observational [Patient Registry] | | | Egypt | ; ; → | Mariam El Ebrashy, PhD;Hend Sakr, PhD;Hend Sakr, PhD→Mariam El Ebrashy, PhD | | ;hend.reda@buc.edu.eg;hend.reda@buc.edu.eg→ | ;+201010151300;01010151300→ | Badr University in Cairo;→Badr University in Cairo |
<br> Inclusion Criteria:
<br>
<br> - Participants recovered from mild to moderated signs and symptoms of COVID- 19 after
<br> one month.
<br>
<br> - Ability to perform pulmonary function tests correctly.
<br>
<br> - COVID-19 was diagnosed by positive polymerase chain reaction (PCR) testing on
<br> nasopharyngeal swab, oxygen saturation was ranged between 92-96% during illness
<br> period.
<br>
<br> - CT chest shows ground glass opacity.
<br>
<br> - Their D-dimer was less than 0.5 µg/ml.
<br>
<br> - Two successive negative PCR were before included in study.
<br>
<br> - Participants were in home isolation during illness period.
<br>
<br> Exclusion Criteria:
<br>
<br> - Chronic respiratory disease.
<br>
<br> - Chronic heart disease.
<br>
<br> - Diabetes mellitus.
<br>
<br> - Smoking.
<br>
<br> - Centralized isolation.
<br>
<br> - Severe COVID-19.
<br> | | Lung Function Decreased;Obesity;Menopause;Covid19 | Device: Spirometry | FEV1/FVC ratio;forced vital capacity (FVC);Forced expiratory volume in the first second (FEV1) | | | | Yes | False | | |
| → | NCT05009030 | 24 August 2021→15 November 2021 | Anti-SARS-COV2 Vaccination Study in Lung Cancer Patients | Observational Study on the Effectiveness and Safety of Vaccination Anti-SARS-CoV2 in Patients With Lung Cancer | VAC-CaP | Fundación GECP | 10/08/2021 | 20210810 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05009030 | Recruiting | No | 18 Years | N/A | All | May 6, 2021 | 500 | Observational | | | Spain | ; | Ernest Nadal, MD;Eva C Pereira | | ;epereira@gecp.org | ;934302006 | Fundación GECP Investigator; |
<br> Inclusion Criteria:
<br>
<br> - Patients diagnosed with lung cancer of any stage and histology who have or have not
<br> contracted COVID-19 and who have been vaccinated with an EMA approved COVID-19
<br> vaccine.
<br>
<br> - Age equal to or greater than 18 years
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who have not received an EMA approved COVID-19 vaccine.
<br> | | Lung Cancer;Covid19 | Drug: COVID-19 vaccine | Incidence of COVID-19 vaccine-Emergent Adverse Events (Safety and Tolerability);Determine the efficacy of the COVID19 vaccine→Determine the efficacy of the COVID19 vaccine;Incidence of COVID-19 vaccine-Emergent Adverse Events (Safety and Tolerability) | | | | Yes | False | | |
| → | NCT05009732 | 27 September 2021→15 November 2021 | A Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects | A Randomized, Double-blind, Placebo-Controlled, Phase III Study to Evaluate the Efficacy and Safety of Proxalutamide (GT0918) in Hospitalized COVID-19 Subjects | | Suzhou Kintor Pharmaceutical Inc, | 16/08/2021 | 20210816 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05009732 | Not recruiting→Recruiting | No | 18 Years | N/A | All | October 2021→September 30, 2021 | 1030 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 3 | →United States | | Lulu Gu→Clinical operation | | IR@kintor.com.cn→kintor.co@kintor.com.cn | 86-18206227504→86-512-62639909 | |
<br> Inclusion Criteria:
<br>
<br> 1. Subject (or legally authorized representative) provides informed consent prior to
<br> initiation of any study procedures.
<br>
<br> 2. Subject (or legally authorized representative) understands and agrees to comply with
<br> planned study procedures.
<br>
<br> 3. Male and non-pregnant female subjects with age =18 years of age at the time of
<br> randomization.
<br>
<br> 4. Admitted to a hospital with symptoms suggestive of COVID-19.
<br>
<br> 5. Has laboratory-confirmed SARS-CoV-2 infection as determined by PCR or other commercial
<br> or public health assay in any specimen, as documented by either of the following:
<br>
<br> - PCR positive in sample collected < 72 hours prior to randomization; OR
<br>
<br> - PCR positive in sample collected = 72 hours prior to randomization, documented
<br> inability to obtain a repeat sample (e.g. due to lack of testing supplies,
<br> limited testing capacity, results taking > 24 hours, etc) AND progressive disease
<br> suggestive of ongoing SARS-CoV-2 infection.
<br>
<br> 6. Illness of any duration, and at least one of the following:
<br>
<br> - Radiographic infiltrates by imaging (chest x-ray, CT scan, etc.), OR
<br>
<br> - SpO2 = 93% on room air, OR
<br>
<br> - Requiring supplemental oxygen
<br>
<br> 7. Women of child-bearing potential, defined as all women physiologically capable of
<br> becoming pregnant, unless they are using highly effective contraception, as shown
<br> below, throughout the study and for 3 months after stopping GT0918 treatment. Highly
<br> effective contraception methods include:
<br>
<br> - Total Abstinence (when this is in line with the preferred and usual lifestyle of
<br> the patient. Periodic abstinence (e.g. calendar, ovulation, symptothermal,
<br> post-ovulation methods) and withdrawal are not acceptable methods of
<br> contraception, or
<br>
<br> - Use of one of the following combinations (a+b or a+c or b+c):
<br>
<br> 1. Use of oral, injected or implanted hormonal methods of contraception or
<br> other forms of hormonal contraception that have comparable efficacy (failure
<br> rate < 1%), for example hormone vaginal ring or transdermal hormone
<br> contraception.
<br>
<br> 2. Placement of an intrauterine device (IUD) or intrauterine system (IUS);
<br>
<br> 3. Barrier methods of contraception: Condom or Occlusive cap (diaphragm or
<br> cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal
<br> suppository;
<br>
<br> - Female sterilization (have had prior surgical bilateral oophorectomy with or
<br> without hysterectomy) or tubal ligation at least six weeks before taking study
<br> treatment. In case of oophorectomy alone, only when the reproductive status of
<br> the woman has been confirmed by follow-up hormone level assessment;
<br>
<br> - Male sterilization (at least 6 months prior to screening). For female subjects on
<br> the study, the vasectomized male partner should be the sole partner for that
<br> subject;
<br>
<br> - In case of use of oral contraception women should have been stable for a minimum
<br> of 3 months before taking study treatment. Women are considered post-menopausal
<br> and not of childbearing potential if they have had 12 months of natural
<br> (spontaneous) amenorrhea with an appropriate clinical profile (e.g. age
<br> appropriate, history of vasomotor symptoms) or have had surgical bilateral
<br> oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks
<br> ago. In the case of oophorectomy alone, only when the reproductive status of the
<br> woman has been confirmed by follow up hormone level assessment, is she considered
<br> not of childbearing potential;
<br>
<br> 8. Regardless of their fertility status, male subjects must agree to either remain
<br> abstinent (if this is their preferred and usual lifestyle) or use condoms as well as
<br> one additional highly effective method of contraception (less than 1% failure rate) or
<br> effective method of contraception with nonpregnant women of childbearing potential
<br> partners for the duration of the study and until 90 days after the last dose. A condom
<br> is required to be used also by vasectomized men in order to prevent delivery of the
<br> drug via seminal fluid.
<br>
<br> 9. Agree not to participate in another clinical trial for the treatment of COVID-19
<br> through Day 60 after first dose.
<br>
<br> Exclusion Criteria:
<br>
<br> Subjects are excluded from the study if any of the following criteria apply:
<br>
<br> 1. ALT/AST > 3 times the upper limit of normal.
<br>
<br> 2. Serum total bilirubin > 1.5 x ULN (upper limit of normal)
<br>
<br> 3. Estimated glomerular filtration rate (eGFR) < 30 ml/min (including patients receiving
<br> hemodialysis or hemofiltration).
<br>
<br> 4. Subjects with significant cardiovascular disease as following:
<br>
<br> i. heart failure NYHA class =3 ii. left ventricular ejection fraction <50% iii. those
<br> with a history of cardiac arrhythmias, including long QT syndrome.
<br>
<br> 5. Neutropenia (absolute neutrophil count <1000 cells/µL) (<1.0 x 10^3/µL).
<br>
<br> 6. Lymphopenia (absolute lymphocyte count <200 cells/µL) (<0.20 x 10^3/µL)
<br>
<br> 7. Pregnancy or breast feeding
<br>
<br> 8. Anticipated discharge from the hospital or transfer to another hospital which is not a
<br> study site within 72 hours.
<br>
<br> 9. Allergy to any study medication.
<br>
<br> 10. Received convalescent plasma or intravenous immunoglobulin [IVIg]) for COVID-19.
<br>
<br> 11. Has received or is receiving corticosteroids at high doses (i.e., dexamethasone > 6mg
<br> per day or equivalent) within 2 weeks of screening.
<br>
<br> 12. Suspected serious, active bacterial, fungal, viral, or other infection (besides
<br> COVID-19) that in the opinion of the investigator could constitute a risk when taking
<br> investigational product.
<br>
<br> 13. Have a history of VTE (deep vein thrombosis [DVT] or pulmonary embolism [PE]) within
<br> 12 weeks prior to screening or have a history of recurrent (>1) VTE (DVT/PE).
<br>
<br> 14. Subject taking or had taken an anti-androgen of any type including androgen
<br> depravation therapy, 5-alpha reductase inhibitors, etc. within 3 months before dosing.
<br>
<br> 15. Have participated, within the last 30 days before dosing, in a clinical study
<br> involving an investigational intervention. If the previous investigational
<br> intervention has a long half-life, 5 half-lives or 30 days, whichever is longer,
<br> should have passed.
<br>
<br> 16. Subjects with myopathy
<br>
<br> 17. Is admitted to Intensive Care Units at randomization
<br> | | Covid19 | Drug: GT0918;Drug: Standard of care;Drug: Matching placebo | The time to sustained recovery is evaluated by Day 30. | | | | Yes | False | | |
| → | NCT05020691 | 7 September 2021→15 November 2021 | NIV in Covid-19 Respiratory Failure | Non-invasive Ventilation in Covid-19 Respiratory Failure - Predicting Success: A Retrospective Observational Study to Determine Predictive Factors in the Success or Failure of Non-invasive Ventilation. | | National Heatlh Service Ayrshire and Arran | 17/08/2021 | 20210817 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05020691 | Not recruiting | No | 18 Years | N/A | All | August 23, 2021→August 18, 2021 | 150→70 | Observational | | | United Kingdom | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Confirmed Covid-19 respiratory failure
<br>
<br> 2. NIV treatment instituted as per clinician decision
<br>
<br> 3. Admitted to HDU or ICU between 1/3/20 and 30/4/21
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Patients with immediate indication for invasive ventilation
<br>
<br> 2. Patients whose primary diagnosis was not Covid-19 respiratory failure, but received
<br> NIV in that time period
<br> | | COVID-19 Pneumonia | | Clinical Improvement;Death Due to Respiratory Failure;Escalation to Invasive Ventilation | | | | Yes | False | | |
| → | NCT05029856 | 20 September 2021→15 November 2021 | Evaluation of the Safety and Immunogenicity of SII Vaccine Constructs Based on the SARS-CoV-2 (COVID-19) Variant in Adults | A Randomized, Observer-Blinded, Phase 1/2 Study With an Open-Label Group to Evaluate the Safety and Immunogenicity of SII Vaccine Constructs Based on SARS-CoV-2 Variants in Adults | | Novavax | 25/08/2021 | 20210825 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05029856 | Not recruiting | No | 18 Years | 64 Years | All | October 4, 2021→February 4, 2022 | 240 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | Australia | | Lisa Golden | | lgolden@novavax.com | +610-999-1180→240-368-5445 | |
<br> Inclusion Criteria:
<br>
<br> 1. Adults 18 to 64 years of age, inclusive, at screening.
<br>
<br> 2. Willing and able to give informed consent prior to study enrollment and to comply with
<br> study procedures.
<br>
<br> 3. Female participants of childbearing potential (defined as any participant who has
<br> experienced menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral
<br> tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at
<br> least 12 consecutive months]) must agree to be heterosexually inactive from at least
<br> 28 days prior to enrollment and through the end of the study OR agree to consistently
<br> use a medically acceptable method of contraception listed below from at least 28 days
<br> prior to enrollment and through the end of the study.
<br>
<br> 1. Condoms (male or female) with spermicide (if acceptable in country)
<br>
<br> 2. Diaphragm with spermicide
<br>
<br> 3. Cervical cap with spermicide
<br>
<br> 4. Intrauterine device
<br>
<br> 5. Oral or patch contraceptives
<br>
<br> 6. Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive
<br> method that is designed to protect against pregnancy
<br>
<br> 7. Abstinence, as a form of contraception, is acceptable if in line with the
<br> participant's lifestyle
<br>
<br> 4. Is medically stable, as determined by the investigator (based on a review of health
<br> status, vital signs [to include body temperature], medical history, and targeted
<br> physical examination [to include body weight]). Vital signs must be within medically
<br> acceptable ranges prior to the first vaccination.
<br>
<br> 5. Agrees to not participate in any other SARS-CoV-2 prevention or treatment trials for
<br> the duration of the study.
<br>
<br> For previously vaccinated Participants (Groups C, D and H):
<br>
<br> 6. Documented receipt of 2 doses of the investigational Novavax vaccine with Matrix-M1
<br> adjuvant (NVX-CoV2373) administered approximately 21 days apart or 2 doses of a
<br> TGA-authorized/approved COVID-19 vaccine administered at least 60 days prior to first
<br> study vaccination.
<br>
<br> Exclusion Criteria:
<br>
<br> If an individual meets any of the following criteria, he or she is ineligible for this
<br> study:
<br>
<br> 1. History of laboratory-confirmed (by PCR or serology to SARS-CoV-2) COVID-19 infection
<br> at any time prior to randomization/enrollment.
<br>
<br> 2. Previous receipt of any investigational or authorized/approved vaccine, prophylactic
<br> or therapeutic agent for the prevention or treatment of SARS-CoV-2 infection, except
<br> for previously vaccinated participants.
<br>
<br> 3. Participation in research involving receipt of investigational products
<br> (drug/biologic/device) within 90 days prior to first study vaccination.
<br>
<br> 4. Received influenza vaccination within 14 days prior to first study vaccination, or any
<br> other vaccine within 30 days prior to the first study vaccination.
<br>
<br> 5. Any known allergies to products contained in the investigational product.
<br>
<br> 6. Any history of anaphylaxis to any prior vaccine.
<br>
<br> 7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring
<br> ongoing immunomodulatory therapy.
<br>
<br> 8. Chronic administration (defined as > 14 continuous days) of immunosuppressants,
<br> systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to
<br> first study vaccination.
<br>
<br> 9. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90
<br> days prior to first study vaccination.
<br>
<br> 10. Active cancer (malignancy) on therapy within 3 years prior to first study vaccination
<br> (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo
<br> maligna and uterine cervical carcinoma in situ without evidence of disease, at the
<br> discretion of the investigator).
<br>
<br> 11. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to
<br> the end of study.
<br>
<br> 12. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to
<br> the first study vaccine dose that, in the opinion of the investigator, might interfere
<br> with protocol compliance.
<br>
<br> 13. Any other condition that, in the opinion of the investigator, would pose a health risk
<br> to the participant if enrolled or could interfere with evaluation of the study vaccine
<br> or interpretation of study results (including neurologic or psychiatric conditions
<br> likely to impair the quality of safety reporting).
<br>
<br> 14. Study team member or immediate family member of any study team member (inclusive of
<br> Sponsor, CRO, and study site personnel involved in the conduct or planning of the
<br> study).
<br> | | Covid19 | Biological: SII B.1.351;Biological: SII B.1.351;Biological: SII Bivalent;Biological: SII Bivalent;Biological: SII B.1.617.2 | Incidence and relationship of medically attended adverse events (MAAEs), adverse events of special interest (AESIs) (predefined list), and serious adverse events (SAEs);Incidence, duration, severity, and relationship of unsolicited AEs through 28 days;Incidence, duration, and severity of solicited local and systemic adverse events (AEs);MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as SCRs/SRRs;MN50 GMTs to the SARS-CoV-2 B.1.617.2 (Delta)expressed as GMT;MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as SCRs/SRRs;MN50 GMTs to the SARS-CoV-2 B.1.351 (Beta) expressed as GMT | | | | Yes | False | | |
| → | NCT05035420 | 1 November 2021→15 November 2021 | A Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases | A Pilot Study to Evaluate a Noninvasive Multimodal Biosensing Device for Screening and Monitoring Response to Treatment of Infectious Respiratory Diseases | | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | 03/09/2021 | 20210903 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05035420 | Recruiting | No | 18 Years | N/A | All | November 3, 2021→November 18, 2021 | 40 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Device Feasibility. Masking: None (Open Label). | N/A | United States | ; ; | Amir Gandjbakhche, Ph.D.;Kosar Khaksari, Ph.D.;For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) | | ;kosar.khaksari@nih.gov;prpl@cc.nih.gov | ;(301) 496-6786;800-411-1222 | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD); |
<br> - INCLUSION CRITERIA:
<br>
<br> In order to be eligible to participate in this study, an individual must meet all of the
<br> following criteria:
<br>
<br> - Provision of signed and dated informed consent form.
<br>
<br> - Stated willingness to comply with all study procedures and availability for the
<br> duration of the study.
<br>
<br> - Male or female aged 18 years or greater.
<br>
<br> - In good general health as evidenced by medical history with no signs of cough, sneeze
<br> and upper respiratory symptoms.
<br>
<br> - Body temperature in normal range (97 degrees - 99 degrees F) on the day of the
<br> experiment.
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> - Any skin disease.
<br>
<br> - Fever (temperature above 99 degrees F).
<br>
<br> - Any past or present cardiovascular or pulmonary diseases.
<br>
<br> - Known adverse reaction to latex.
<br>
<br> - Any medical condition that, in the opinion of the Principal Investigator would
<br> preclude the inclusion of a patient onto this research study.
<br>
<br> - Unable or unwilling to give informed consent.
<br>
<br> - Individuals with known respiratory conditions.
<br>
<br> - Individuals who are currently taking medication that may cause methemoglobinemia such
<br> as nitrates derivatives, sulfonamides, dapsone, phenacetin, phenazopyridine, some
<br> local anesthetics such as prilocaine, topical anesthetics such as emla cream,
<br> benzocaine.
<br>
<br> - Individuals with history of seizure.
<br>
<br> - Smokers and those on narcotics.
<br>
<br> - Pregnant women are excluded due to risk associated to hypercapnia risk
<br> | | COVID-19;Upper Respiratory Infection;Lower Respiratory Infection | Device: Fitbit;Device: Douglas Bag;Device: Periflux 6000 EPOS;Device: BIOPAC;Device: Flowmet;Device: NIRS | Compare performance of a multimodal biosensor device with commercial systems for measuring vital physiological signals including cardiac, respiratory, and tissue oxygenation in individuals at rest. | | | | Yes | False | | |
| → | NCT05037097 | 13 September 2021→15 November 2021 | A Trial Evaluating the Safety and Immunogenicity of 3 COVID-19 SARS-CoV-2 RNA Vaccines in Healthy Adults | A Phase 1/2 Randomized, Observer-Blind Study of the Safety, Reactogenicity, and Immunogenicity of 3 SARS-CoV-2 RNA Vaccine Candidates in Adults Previously Vaccinated and Not Previously Vaccinated Against SARS-CoV-2 | | Arcturus Therapeutics, Inc. | 30/08/2021 | 20210830 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05037097 | Recruiting | No | 21 Years | 80 Years | All | August 30, 2021 | 72 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | United States;Singapore;United States | | Arcturus Therapeutics | | clinicaltrials@arcturusrx.com | (858) 900-2660 | |
<br> Inclusion Criteria:
<br>
<br> Individuals who:
<br>
<br> 1. Are able to provide consent
<br>
<br> 2. Agree to comply with all study visits and procedures
<br>
<br> 3. Are willing and able to adhere to study restrictions
<br>
<br> 4. Are sexually active and willing to adhere to contraceptive requirements
<br>
<br> 5. Are male, female, or transgender =21 to =80 years of age
<br>
<br> 6. For the previously vaccinated groups only, received 2 doses of SARS-CoV-2 vaccine 5
<br> months or longer prior to study enrollment
<br>
<br> Exclusion Criteria:
<br>
<br> Individuals who:
<br>
<br> 1. For the unvaccinated groups only, previously received any investigational or
<br> authorized MERS-CoV, SARS-CoV, and SARS-CoV-2 vaccines (including ARCT-021)
<br>
<br> 2. For the previously vaccinated groups only, previously received BNT162b2 but have not
<br> received 2 doses within at least 5 months prior to study enrollment
<br>
<br> 3. Are planning to receive other COVID-19 vaccines during the study period
<br>
<br> 4. Recently received other vaccines
<br>
<br> 5. Have a fever or are feeling sick close to the time of the first study vaccination
<br>
<br> 6. Have a known history of COVID-19 disease or asymptomatic SARS-CoV-2 infection
<br>
<br> 7. Are pregnant or breastfeeding
<br>
<br> 8. Have had a severe reaction to previous vaccines
<br>
<br> 9. Have a severe or uncontrolled disease(s) that may interfere with the interpretation of
<br> the study
<br>
<br> 10. Have some respiratory diseases
<br>
<br> 11. Have some significant heart diseases
<br>
<br> 12. Have some neurological conditions
<br>
<br> 13. Have sickle cell disease or some other blood disorders
<br>
<br> 14. Have had a major surgery within the past 6 months
<br>
<br> 15. Have a history of chronic liver disease
<br>
<br> 16. Have a history of autoimmune disease or immunodeficiency
<br>
<br> 17. Have received allergy injections, interferon, immunomodulators, cytotoxic drugs or
<br> other similar toxic drugs.
<br>
<br> 18. Have received blood products
<br>
<br> 19. Have a positive test for hepatitis B or C or human immunodeficiency virus
<br>
<br> 20. Have uncontrolled hypertension
<br>
<br> 21. Have had cancer except for cancers that were treated and that have low risk of
<br> returning
<br>
<br> 22. Are obese
<br>
<br> 23. Are Investigator site staff members, employees of Arcturus or the contract research
<br> organization (CRO) directly involved in the conduct of the study, or site staff
<br> members otherwise supervised by the Investigator or immediate family members of any of
<br> the previously mentioned individuals
<br> | | COVID-19;SARS-CoV-2 Infection;Corona Virus Infection | Biological: ARCT-165;Biological: ARCT-154;Biological: ARCT-021 | Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels;Changes in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs;SARS-CoV-2 full-length spike, RBD, and N binding antibody levels, expressed as GMCs;GMT ratio (ARCT-021/ARCT-165, ARCT-165/ARCT-154, and ARCT-021/ARCT-154);Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels;Changes in SARS-CoV-2 serum neutralizing levels from before vaccination to each subsequent time point, expressed as GMFRs;SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs;Percentage of participants reporting serious adverse events;Percentage of participants reporting adverse events leading to discontinuation from study vaccine/study withdrawal;Percentage of participants reporting medically attended adverse events;Percentage of participants reporting unsolicited adverse events;Percentage of participants reporting solicited local or systemic adverse events→Percentage of participants reporting serious adverse events;SARS-CoV-2 serum neutralizing antibody levels, expressed as GMTs;Changes in SARS-CoV-2 serum neutralizing levels from before vaccination to each subsequent time point, expressed as GMFRs;Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 serum neutralizing antibody levels;GMT ratio (ARCT-021/ARCT-165, ARCT-165/ARCT-154, and ARCT-021/ARCT-154);SARS-CoV-2 full-length spike, RBD, and N binding antibody levels, expressed as GMCs;Changes in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels from before vaccination to each subsequent time point, expressed as GMFRs;Percentages of participants achieving greater than or equal to 4-fold rise from before vaccination in SARS-CoV-2 full-length spike, RBD, and N binding antibody levels;Percentage of participants reporting adverse events leading to discontinuation from study vaccine/study withdrawal;Percentage of participants reporting medically attended adverse events;Percentage of participants reporting unsolicited adverse events;Percentage of participants reporting solicited local or systemic adverse events | | | | Yes | False | | |
| → | NCT05038475 | 20 September 2021→15 November 2021 | Clinical and Immunological Responses After SARS-CoV-2 Infection Causing COVID-19 | Longitudinal Observation of Clinical and Immunological Profiles After SARS-Cov-2 Infection | | Association "Naso Sano" Onlus | 10/06/2021 | 20210610 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05038475 | Recruiting | No | 18 Years | 80 Years | All | May 1, 2020 | 100 | Observational | | | Italy | | Puya Dehgani-Mobaraki, MD | | | | Associazione Naso sano, Italy |
<br> Inclusion Criteria:
<br>
<br> 1. Individuals who tested positive for SARS-CoV-2 in March 2020 and are not vaccinated.
<br>
<br> 2. No acute respiratory infection or active SARS-CoV-2 infection.
<br>
<br> 3. Informed consent of the adult participant.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Individuals <18 years or >80 years.
<br>
<br> 2. No informed consent by the adult participant.
<br>
<br> 3. Individuals who have been vaccinated.
<br>
<br> 4. Suspicion of acute COVID-19 infection.
<br> →
<br> Inclusion Criteria:
<br>
<br> 1. Individuals who tested positive for SARS-CoV-2 in March 2020. These patients will be
<br> divided into two groups and followed up over time. The first group will include
<br> patients who have recovered and have not received the vaccine. The second group will
<br> include patients who have recovered and have received the vaccine.
<br>
<br> 2. No acute respiratory infection or active SARS-CoV-2 infection.
<br>
<br> 3. Informed consent of the adult participant.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Individuals <18 years or >80 years.
<br>
<br> 2. No informed consent by the adult participant.
<br>
<br> 3. Suspicion of acute COVID-19 infection
<br> | | Covid19;SARS-CoV2 Infection | Diagnostic Test: COVID-19 antibody test | Analysis of demographic profile (Age) of recovered COVID-19 patients [at inclusion];Analysis of demographic profile (Gender) of recovered COVID-19 patients [at inclusion];Analysis of demographic profile (occupation) of recovered COVID-19 patients [at inclusion];Analysis of clinical profile of recovered COVID-19 patients [at inclusion];Analysis of associated co-morbidities in recovered COVID-19 patients [at inclusion];Analysis of immunological profile recovered COVID-19 patients [at inclusion];Seroprevalence of IgM and IgG against Nucleocapsid of SARS-CoV-2 (in AU/ml) [from T0 to T5];Seroprevalence of IgM and IgG against spike-receptor binding domain of SARS-CoV-2 (in AU/ml) [from T6 to T8]→Analysis of demographic profile (Age) of recovered COVID-19 patients [at inclusion];Analysis of demographic profile (Gender) of recovered COVID-19 patients [at inclusion];Analysis of demographic profile (occupation) of recovered COVID-19 patients [at inclusion];Analysis of clinical profile of recovered COVID-19 patients [at inclusion];Analysis of associated co-morbidities in recovered COVID-19 patients [at inclusion];Analysis of immunological profile recovered COVID-19 patients [at inclusion];Seroprevalence of IgM and IgG against Nucleocapsid of SARS-CoV-2 (in AU/ml) [from T0 to T5];Seroprevalence of IgM and IgG against spike-receptor binding domain of SARS-CoV-2 (in AU/ml) [from T6 to T8];Seroprevalence of IgM and IgG against spike-receptor binding domain of SARS-CoV-2 (in AU/ml) for vaccinated individuals | | | | No | False | | |
| → | NCT05038618 | 18 October 2021→15 November 2021 | A Study o Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901, CT-COV-21 Sub-study | A Phase II, Prospective, Open-Label, Single-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of COVID-19 Vaccine Candidate MVC-COV1901, CT-COV-21 Sub-study | | Medigen Vaccine Biologics Corp. | 25/08/2021 | 20210825 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05038618 | Not recruiting | No | 20 Years | 64 Years | All | August 2, 2021 | 400→399 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 2 | Taiwan | ; | Szu-Min Hsieh, MD;Tzou-Yien Lin, MD | | ; | ; | National Taiwan University Hospital;Chang Gang Memorial Hospital, LinKou |
<br> Inclusion Criteria:
<br>
<br> 1. Male or female participant = 20 to < 65 years, or = 65 years of age at randomization.
<br>
<br> 2. Healthy adults or adults with pre-existing medical conditions who are in stable
<br> condition. A stable medical condition is defined as disease not requiring significant
<br> change in therapy or hospitalization for worsening disease 3 months before enrollment
<br> and expected to remain stable for the duration of the study.
<br>
<br> 3. Female participant must:
<br>
<br> 1. Be either of non-childbearing potential, i.e. surgically sterilized (defined as
<br> having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral
<br> salpingectomy; tubal ligation alone is not considered sufficient) or one year
<br> post-menopausal;
<br>
<br> 2. Or, if of childbearing potential, be abstinent or agree to use medically
<br> effective contraception from 14 days before screening to 30 days following the
<br> last injection of study intervention. Acceptable forms include:
<br>
<br> i. Implanted hormonal methods of contraception or placement of an intrauterine device
<br> or intrauterine system ii. Established use of hormonal methods (injectable, pill,
<br> patch or ring) combined with barrier methods of contraception: condom or occlusive cap
<br> (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository c.
<br> Have a negative pregnancy test
<br>
<br> 4. Participant is willing and able to comply with all required study visits and follow-up
<br> required by this protocol.
<br>
<br> 5. Participant has not travelled overseas within 14 days of screening and will not have
<br> any oversea travelling throughout the study period.
<br>
<br> 6. Participant or the participant's legal representative must understand the procedures
<br> of the study and provide written informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnant or breast feeding or have plan to become pregnant in 30 days after last
<br> administration of study intervention.
<br>
<br> 2. Employees at the investigator's site, of the Sponsor or the contract research
<br> organization (CRO) directly involved in the conduct of the study.
<br>
<br> 3. Currently receiving or received any investigational intervention within 30 days prior
<br> to the first dose of study intervention.
<br>
<br> 4. Administered any licensed live-attenuated vaccines within 28 days or other licensed
<br> non-live-attenuated vaccines within 7 days prior to the first dose of study
<br> intervention.
<br>
<br> 5. Administered any blood product or intravenous immunoglobulin administration within 12
<br> weeks prior to the first dose of study intervention.
<br>
<br> 6. Currently receiving or anticipate to receive concomitant immunosuppressive or
<br> immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing
<br> corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone
<br> less than 20 mg or equivalent) within 12 weeks prior to the first dose of study
<br> intervention.
<br>
<br> 7. Currently receiving or anticipate to receive treatment with tumor necrosis factor
<br> (TNF)-a inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to
<br> the first dose of study intervention.
<br>
<br> 8. Major surgery or any radiation therapy within 12 weeks prior to the first dose of
<br> study intervention Medical Conditions
<br>
<br> 9. Immunosuppressive illness or immunodeficient state, including hematologic malignancy,
<br> history of solid organ, bone marrow transplantation, or asplenia.
<br>
<br> 10. A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma,
<br> polyarthritis, thyroiditis, Guillain-Barré syndrome, etc.).
<br>
<br> 11. A history of malignancy with potential risk for recurrence after curative treatment,
<br> or current diagnosis of or treatment for cancer (exceptions are squamous and basal
<br> cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the
<br> discretion of the investigator).
<br>
<br> 12. Bleeding disorder considered a contraindication to intramuscular injection or
<br> phlebotomy.
<br>
<br> 13. Human immunodeficiency virus (HIV) antibody positive participants with CD4 count < 350
<br> cells/mm3 or a detectable HIV viral load within the past year (low level variations
<br> from 50-500 viral copies/mL or equivalent which do not lead to changes in
<br> antiretroviral therapy [ART] are permitted).
<br>
<br> 14. Hepatitis B surface antigen (HBsAg) positive participant with positive hepatitis B e
<br> antigen (HBeAg) or abnormal liver function.
<br>
<br> 15. Hepatitis C virus (HCV) antibody positive participants with detectable HCV ribonucleic
<br> acid (RNA) viremia in recent 12 weeks.
<br>
<br> 16. Participant with ongoing acute diseases or serious medical conditions which will
<br> interfere with adherence to study requirements, or the evaluation of any study
<br> endpoint. Acute diseases or serious medical conditions include cardiovascular (e.g.
<br> New York Heart Association Grade III or IV), pulmonary (e.g. chronic obstructive
<br> pulmonary disease stage III or IV), hepatic (e.g. Child-Pugh Class C), neurologic
<br> (e.g. dementia), metabolic (e.g. diabetes mellitus with hemoglobin A1c [HbA1c] > 8%),
<br> renal (Stage 3 or worse chronic kidney disease), psychiatric condition (e.g.
<br> alcoholism, drug abuse), current severe infections, medical history, physical
<br> findings, or laboratory abnormality that in the investigators' opinion are not in
<br> stable condition and participating in the study could adversely affect the safety of
<br> the participant.
<br>
<br> Medigen Vaccine Biologics Corp. 34
<br>
<br> 17. Participant with previous known or potential exposure to SARS-CoV-1 or 2 viruses
<br> (EXCEPT for those who have been tested negative and completed the 14-day
<br> self-managements/ home quarantines/ home isolations) or received any other COVID-19
<br> vaccine.
<br>
<br> 18. Participant with a history of hypersensitivity to any vaccine or a history of allergic
<br> disease or reactions likely to be exacerbated by any component of the MVC-COV1901.
<br>
<br> 19. Body (oral, rectal, or ear) temperature = 38.0°C or acute illness (not including minor
<br> illnesses such as diarrhea or mild upper respiratory tract infection at the discretion
<br> of the investigator) within 2 days before the first dose of study intervention.
<br> | | Covid19 Vaccine | Biological: MVC-COV1901(S protein with adjuvant) | Incidence of Adverse Event within 28 days post the second study intervention (Safety of MVC-COV1901);Immunogenicity of MVC-COV1901 | | | | Yes | False | | |
| → | NCT05042063 | 20 September 2021→15 November 2021 | Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease | Acoustic Cough Monitoring for the Management of Patients With Known Respiratory Disease | | Clinica Universidad de Navarra, Universidad de Navarra | 02/09/2021 | 20210902 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05042063 | Not recruiting→Recruiting | No | 5 Years | 100 Years | All | September 15, 2021 | 100 | Observational | | | →Spain | ; → ; ; | Carlos Chaccour, MD, PhD;Carlos Chaccour, MD, PhD→Carlos Chaccour, MD, PhD;Carlos Chaccour, MD, PhD;Carlos Chaccour, MD | | ;cchaccour@unav.es→;cchaccour@unav.es;carlos.chaccour@isglobal.org | ;+34948255400→;+34948255400; | Clinica Universidad de Navarra; |
<br> Inclusion Criteria:
<br>
<br> For participants in the main study group
<br>
<br> - Outpatient or inpatients at the Clinical Universidad de Navarra with a complaint of
<br> cough.
<br>
<br> - The patient or his/her legal representative, have given consent to participate in the
<br> study.
<br>
<br> For participants in the sub-study group:
<br>
<br> - Being 18 years or older.
<br>
<br> - Providing consent for the sub-study
<br>
<br> Exclusion Criteria:
<br>
<br> - Inability to accept the privacy policy and terms of use of Hyfe.
<br>
<br> - Lack of access to a Wi-Fi network at the site of residence (for the main study group).
<br>
<br> - Unwillingness to regularly use the cough-surveillance system throughout the monitoring
<br> period
<br> →
<br> Inclusion Criteria:
<br>
<br> For participants in the main study group
<br>
<br> - Outpatient or inpatients at the Clinical Universidad de Navarra with a complaint of
<br> cough.
<br>
<br> - The patient or his/her legal representative, have given consent to participate in the
<br> study.
<br>
<br> For participants in the sub-study groups:
<br>
<br> - Being 18 years or older.
<br>
<br> - Providing consent for the sub-study
<br>
<br> Exclusion Criteria:
<br>
<br> - Inability to accept the privacy policy and terms of use of Hyfe.
<br>
<br> - Lack of access to a Wi-Fi network at the site of residence (for the main study group).
<br>
<br> - Unwillingness to regularly use the cough-surveillance system throughout the monitoring
<br> period
<br> | | Cough;COPD;GERD;Asthma;Tuberculosis;Non-Tuberculous Mycobacterial Pneumonia;COVID-19 Pneumonia | Device: Hyfe Cough Tracker→Device: Hyfe Cough Tracker;Device: Hyfe Air | Correlation between subjective perception of cough and objective frequency | | | | Yes | False | | |
| → | NCT05044780 | 1 November 2021→15 November 2021 | Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19 | Hyperspectral Analysis of Sweat Metabolite Biometrics for Real-Time Detection of COVID-19 | | National Cancer Institute (NCI) | 14/09/2021 | 20210914 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05044780 | Not recruiting | No | 18 Years | N/A | All | November 3, 2021→November 18, 2021 | 100 | Observational | | | United States | ; ; | James L Gulley, M.D.;Manuk Manukyan;Steven Nathan, M.D. | | ;manuk.manukyan@nih.gov;steven.nathan@inova.org | ;(240) 781-3447;703-776-2986 | National Cancer Institute (NCI); |
<br> - INCLUSION CRITERIA:
<br>
<br> Eligible subjects must meet the following inclusion criteria:
<br>
<br> - Age >=18 years.
<br>
<br> - Must have a standard of care molecular testing positive for COVID19 to be enrolled in
<br> cohort 1 or a standard of care molecular testing negative for COVID19 to be enrolled
<br> in cohort 2 done within 7 days
<br>
<br> - Ability of subject or Legally Authorized Representative (LAR) to understand and the
<br> willingness to sign a written informed consent document
<br>
<br> EXCLUSION CRITERIA:
<br>
<br> Subjects with the following characteristics will be excluded from the study:
<br>
<br> -Participants started on treatment with remdesivir and/or dexamethasone for the treatment
<br> of COVID19
<br> | | COVID-19 | | Hyperspectal Analysis | | | | Yes | False | | |
| → | NCT05046548 | 27 September 2021→15 November 2021 | This is a Double-blind, Placebo-controlled, Randomized Study of the Tolerability, Safety and Immunogenicity of an Inactivated Whole Virion Concentrated Purified Vaccine (CoviVac) Against Covid-19 | Double-blind, Placebo-controlled, Randomized Study of Tolerability, Safety and Immunogenicity of the Inactivated Whole-virion Concentrated Purified Coronavirus Vaccine, Produced by FSBSI "Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products", on Volunteers at the Age of 18-60 Years | | Chumakov Federal Scientific Center for Research and Development of Immune-and-Biological Products | 26/08/2021 | 20210826 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05046548 | Not recruiting | No | 18 Years | 60 Years | All | October 3, 2020 | 400 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 1/Phase 2 | Russian Federation | | | | | | |
<br> Inclusion criteria:
<br>
<br> Volunteers must meet the following inclusion criteria:
<br>
<br> - Healthy volunteers (men and women) aged 18-60;
<br>
<br> - Written informed consent of volunteers to participate in a clinical trial;
<br>
<br> - Volunteers who are able to comply with the requirements of the Protocol (i.e. filling
<br> out the Self-Observation Diary, come to control visits);
<br>
<br> - For women capable of childbearing, a negative pregnancy test and consent to adhere to
<br> adequate contraceptive methods (use of contraceptives within six months after the
<br> second vaccination). Women should use contraceptive methods that are more than 90%
<br> reliable (cervical caps with spermicide, diaphragms with spermicide, condoms,
<br> intrauterine devices), or be sterile or postmenopausal.
<br>
<br> - For fertile men, consent to adhere to adequate contraceptive methods for six months
<br> after the second vaccination. Men and their sexual partners must use contraceptive
<br> methods with more than 90% reliability (cervical caps with spermicide, diaphragms with
<br> spermicide, condoms, intrauterine devices), or be sterile.
<br>
<br> Non-inclusion criteria:
<br>
<br> Volunteers cannot be included in the study if any of the following criteria are met:
<br>
<br> - Medical staff of clinics and polyclinics;
<br>
<br> - A history of severe acute respiratory syndrome (SARS) or Middle East respiratory
<br> syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63,
<br> HCoV-HKU1);
<br>
<br> - History of contacts with confirmed or suspected cases of SARS-CoV-2 infection within 1
<br> month;
<br>
<br> - Positive IgM or IgG to SARS-CoV-2, found at screening (for volunteers of Phases I and
<br> II);
<br>
<br> - Positive PCR test for SARS-CoV-2 at screening;
<br>
<br> - Clinically and/or laboratory (according to PCR) confirmed disease with SARS-CoV-2
<br> coronavirus at the current time or in history;
<br>
<br> - Serious post-vaccination reaction (temperature above 40 C, hyperemia or edema more
<br> than 8 cm in diameter) or complication (collapse or shock-like state that developed
<br> within 48 hours after vaccination; convulsions, accompanied or not accompanied by a
<br> febrile state) to any previous vaccination in history;
<br>
<br> - Aggravated allergic history (anaphylactic shock, Quincke's edema, polymorphic
<br> exudative eczema, atopy, history of serum sickness, history of hypersensitivity or
<br> allergic reactions to the administration of any vaccines, known allergic reactions to
<br> vaccine components, etc.);
<br>
<br> - History of Guillain-Barré syndrome (acute polyradiculitis);
<br>
<br> - Previous vaccination with rabies vaccines less than 2 months before immunization or
<br> planned vaccination with rabies vaccines within 1 month after immunization with
<br> investigational vaccines;
<br>
<br> - Vaccination with any other vaccine within 1 month preceding vaccination;
<br>
<br> - A history of leukemia, tuberculosis, cancer, autoimmune diseases;
<br>
<br> - Positive blood test for HIV, syphilis, hepatitis B/C;
<br>
<br> - Volunteers who received immunoglobulin preparations or blood transfusions within the
<br> last 3 months prior to the start of the study based on the history;
<br>
<br> - Long-term use (more than 14 days) of immunosuppressants or other immunomodulatory
<br> drugs during the six months preceding the study, according to the history;
<br>
<br> - Any history of any confirmed or suspected immunosuppressive or immunodeficient
<br> condition;
<br>
<br> - Chronic diseases of the cardiovascular, bronchopulmonary, neuroendocrine systems,
<br> gastrointestinal tract, liver, kidneys, hematopoietic, immune systems, mental illness
<br> in exacerbation stage or decompensation stage (recovery earlier than 4 weeks before
<br> vaccination) in history;
<br>
<br> - Disorder of blood clotting, a tendency to thrombosis in the anamnesis;
<br>
<br> - Progressive neurological pathology, a history of convulsive syndrome;
<br>
<br> - Diabetes mellitus, hyperthyroidism or other endocrine diseases in history;
<br>
<br> - Treatment with glucocorticosteroids, including low doses, as well as topical use of
<br> drugs containing steroids (> 10 mg prednisolone, or an equivalent, for more than 14
<br> days in the last three months);
<br>
<br> - According to the anamnesis, the volunteer was/is registered in a tuberculosis
<br> dispensary and/or a narcological dispensary and/or a neuropsychiatric dispensary
<br> and/or others;
<br>
<br> - Acute infectious diseases (recovery earlier than 4 weeks before vaccination) according
<br> to the history;
<br>
<br> - Taking more than 10 units of alcohol per week or anamnestic information about
<br> alcoholism, drug addiction, or drug abuse;
<br>
<br> - Smoking more than 10 cigarettes a day;
<br>
<br> - Participation in any other clinical study within the last 3 months;
<br>
<br> - Pregnancy or breastfeeding;
<br>
<br> - Axillary temperature at the time of vaccination is more than 37.0 °C;
<br>
<br> - Body mass index less than 18 or more than 28 kg/m2;
<br>
<br> - Serious concomitant diseases or pathological conditions not listed above, which,
<br> according to the investigator, could complicate the evaluation of the study results,
<br> including pathological deviations from the age norms and laboratory norms of blood and
<br> urine parameters, clinically significant, according to the investigator.
<br>
<br> Exclusion criteria:
<br>
<br> - Withdrawal of informed consent by a volunteer;
<br>
<br> - Serious adverse events or adverse events that do not meet the criteria for severity,
<br> the development of which, in the opinion of the investigator, may be detrimental to
<br> the health or well-being of the volunteer;
<br>
<br> - The need for procedures and/or drug treatment not permitted by the Study Protocol;
<br>
<br> - The volunteer was included in violation of the inclusion/non-inclusion criteria of the
<br> Protocol;
<br>
<br> - The emergence of non-inclusion criteria during the study;
<br>
<br> - The need for surgical intervention;
<br>
<br> - Any condition in a volunteer requiring, in the reasonable opinion of the investigating
<br> physician, the withdrawal of the volunteer from the study;
<br>
<br> - The volunteer refuses to cooperate or is undisciplined (for example, not showing up
<br> for a planned visit without warning the investigator and/or losing contact with the
<br> volunteer), or has dropped out of observation;
<br>
<br> - For administrative reasons (termination of the study by the Sponsor or regulatory
<br> authorities), as well as for gross violations of the protocol that could affect the
<br> study results.
<br> | | Coronavirus Infections;Vaccine | Biological: Vaccine for intramuscular injection;Other: Placebo comparator (without active ingredient) for intramuscular injection | Geometric mean titer (GMT) | | | | No | False | | |
| → | NCT05046561 | 20 September 2021→15 November 2021 | Study to Reinforce Immunity (STRI) Phase 2 Clinical Trial | Study to Reinforce Immunity (STRI) - A Phase 2 Double-Blind, Randomized, Placebo-Controlled Study to Investigate The Safety and Efficacy of STRI Formula in Non-Hospitalized Participants With COVID-19 | | Eyecheck, Inc. | 08/09/2021 | 20210908 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05046561 | Not recruiting→Recruiting | No | 18 Years | N/A | All | September 2021→November 4, 2021 | 598 | Interventional | Allocation: Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator). | Phase 2 | →United States | ; → ; ; | Rama D Jager, MD;Rama D Jager, MD→Rama D Jager, MD;Rama D Jager, MD;Taron Asatryan, BSLAS | | ;rama.jager@eyecheck.com→;rama.jager@eyecheck.com;tasatryan@beatcovidtrial.com | ;7086204608→;7086204608;708-620-4608 | Eyecheck, Inc.; |
<br> Inclusion Criteria:
<br>
<br> 1. Adults residing in the United States aged 18 years or older.
<br>
<br> 2. Provision of documentation of positive SARS-CoV-2 testing (via RT-PCR, rapid antigen
<br> testing) performed less than 7 days before screening, either via direct upload or
<br> confirmation from PCP.
<br>
<br> 1. electronic secure document upload;
<br>
<br> 2. allowing STRI Personnel to contact the PCP to confirm diagnosis; or
<br>
<br> 3. allowing STRI Personnel to contact the laboratory where the RT-PCR analysis was
<br> performed
<br>
<br> 3. Initial date of onset of COVID-19 signs/symptoms 7 days or less from date of STRI
<br> Screening and Randomization (i.e., Day 0).
<br>
<br> 4. During screening (Day 0):
<br>
<br> 1. participant-reported response of "Mild" or "Moderate" in response to the question
<br> "Overall, how severe were your infection symptoms today?" (FLU-PRO Plus Global
<br> Additional Daily Diary Items Question 1)
<br>
<br> 2. During prescreening, participant self-reported response of "A little worse" or
<br> "Somewhat worse" or "Much worse" or "About the same" in response to the question
<br> "Overall, how were your infection symptoms today compared to yesterday?" (FLU-PRO
<br> Plus Global Additional Daily Diary Items Question 2)
<br>
<br> 3. During prescreening, participant-reported response of "No" in response to the
<br> question "Have you returned to your usual health today?" (FLU-PRO Plus Global
<br> Additional Daily Diary Items Question 6)
<br>
<br> 4. At least TWO participant self-reported responses of "Somewhat," "Quite A Bit," or
<br> "Very Much" in any FLU-PRO Plus domain other than smell and taste (i.e., nose,
<br> throat, eyes, chest/respiratory, head, gastrointestinal, or body/systemic
<br> domains)
<br>
<br> 5. Ability to self-measure and self-report body temperature, and peripheral oxygen
<br> saturation (with STRI provided thermometer and STRI provided pulse oximeter).
<br>
<br> 6. Provision of signed and dated electronic informed consent form (via 21 CFR Part 11
<br> compliant platform).
<br>
<br> 7. Provision of participant's primary care physician (PCP) name and phone number.
<br>
<br> 8. Consent to allow STRI Personnel to contact PCP for any reason and discuss
<br> participant's medical history and/or obtain participant's medical records.
<br>
<br> 9. Stated willingness to comply with all study procedures and availability for the
<br> duration of the study, including intent to comply with lifestyle considerations
<br> throughout Study duration.
<br>
<br> 10. Ability to take oral medication and be willing to adhere to the STRI Intervention
<br> Product (STRI Formula or placebo as capsules) regimen.
<br>
<br> 11. Ability to use the internet daily and check email daily.
<br>
<br> 12. Ability and consent to send and receive SMS text messages via cellular phone.
<br>
<br> 13. Provision of information (name, email address, and cellular phone number) of an
<br> emergency contact (e.g., family member/friend/colleague) willing to communicate with
<br> STRI Personnel in case the participant deteriorates.
<br>
<br> 14. For men and women with child-bearing potential (as defined below), willingness to use
<br> adequate contraception for at least 90 days after completing self-administration of
<br> the STRI Intervention Product.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Any usage within the past month of any dietary supplement other than a general
<br> multivitamin.
<br>
<br> 2. Inability to comply with study or follow-up procedures, or provide regular updates to
<br> their health status when contacted by the STRI Personnel via email, SMS, or phone.
<br>
<br> 3. Any prior or current hospitalization for COVID-19 or any need for hospitalization for
<br> any reason.
<br>
<br> 4. Any prior or current treatment with any agent for COVID-19 as part of COVID-19
<br> clinical trial.
<br>
<br> 5. Any known allergies or known toxicities to any of the specific ingredients in STRI
<br> Formula (including ascorbic acid, vitamin D, zinc, copper, amla, caffeic acid, coffee,
<br> bovine lactoferrin, milk, quercetin, hesperidin, oranges, citrus fruits, and/or green
<br> tea)
<br>
<br> 6. Body Mass Index > 40 based on participant-reported weight and participant-reported
<br> height.
<br>
<br> 7. Participant-reported weight of less than 35kg.
<br>
<br> 8. Any history of radiation or chemotherapy for cancer within the last 3 months.
<br>
<br> 9. Any history of cardiac arrythmias, hemochromatosis, renal (including any known GFR <
<br> 60mL/min) or hepatic disease (including chronic liver disease).
<br>
<br> 10. Any history of chronic pulmonary disorders
<br>
<br> 11. Any history of any gastrointestinal surgery or disease (including bariatric surgery or
<br> gastrointestinal resection, inflammatory bowel disease, or chronic intestinal
<br> diseases, such as (but not limited to) eosinophilic enteritis or autoimmune
<br> enteritis).
<br>
<br> 12. Any history of mineral or vitamin overload or deficiency (including chronic iron
<br> overload states, copper overload states, or ascorbic acid, vitamin D, zinc, or copper
<br> deficiencies).
<br>
<br> 13. Any history of any adverse event to green tea extract or any herbal products.
<br>
<br> 14. Any current moderate alcohol consumption, defined as 1 standard drink per day for
<br> women and 2 drinks per day for men; whereby 1 standard drink is equivalent to: 12 oz
<br> beer (5% alcohol); 5 ounces of wine (12% alcohol), and 1.5 ounces of 80 proof (40%
<br> alcohol).
<br>
<br> 15. AUDIT screen result of 8 or more indicating hazardous or harmful alcohol consumption,
<br> or alcohol dependence.
<br>
<br> 16. Pregnant or nursing/breastfeeding participants or participants intending to become
<br> pregnant within the next 24 months.
<br>
<br> 17. Men or premenopausal women not using adequate contraception.
<br>
<br> 18. Any other factors as judged by the principal investigator that would cause harm or
<br> increased risk to the participant or preclude the participant's full adherence with or
<br> completion of the study.
<br> →
<br> Inclusion Criteria:
<br>
<br> 1. Adults residing in the United States aged 18 years or older.
<br>
<br> 2. Provision of documentation of positive SARS-CoV-2 testing (via RT-PCR, rapid antigen
<br> testing) performed less than 7 days before screening, either via direct upload or
<br> confirmation from PCP.
<br>
<br> 1. electronic secure document upload;
<br>
<br> 2. allowing STRI Personnel to contact the PCP to confirm diagnosis; or
<br>
<br> 3. allowing STRI Personnel to contact the laboratory where the RT-PCR analysis was
<br> performed
<br>
<br> 3. Initial date of onset of COVID-19 signs/symptoms 7 days or less from date of STRI
<br> Screening and Randomization (i.e., Day 0).
<br>
<br> 4. During screening (Day 0):
<br>
<br> 1. participant-reported response of "Mild" or "Moderate" in response to the question
<br> "Overall, how severe were your infection symptoms today?" (FLU-PRO Plus Global
<br> Additional Daily Diary Items Question 1)
<br>
<br> 2. During prescreening, participant self-reported response of "A little worse" or
<br> "Somewhat worse" or "Much worse" or "About the same" in response to the question
<br> "Overall, how were your infection symptoms today compared to yesterday?" (FLU-PRO
<br> Plus Global Additional Daily Diary Items Question 2)
<br>
<br> 3. During prescreening, participant-reported response of "No" in response to the
<br> question "Have you returned to your usual health today?" (FLU-PRO Plus Global
<br> Additional Daily Diary Items Question 6)
<br>
<br> 4. At least TWO participant self-reported responses of "Somewhat," "Quite A Bit," or
<br> "Very Much" in any FLU-PRO Plus domain other than smell and taste (i.e., nose,
<br> throat, eyes, chest/respiratory, head, gastrointestinal, or body/systemic
<br> domains)
<br>
<br> 5. Ability to self-measure and self-report body temperature, and peripheral oxygen
<br> saturation (with STRI provided thermometer and STRI provided pulse oximeter).
<br>
<br> 6. Provision of signed and dated electronic informed consent form (via 21 CFR Part 11
<br> compliant platform).
<br>
<br> 7. Provision of participant's primary care physician (PCP) name and phone number.
<br>
<br> 8. Consent to allow STRI Personnel to contact PCP for any reason and discuss
<br> participant's medical history and/or obtain participant's medical records.
<br>
<br> 9. Stated willingness to comply with all study procedures and availability for the
<br> duration of the study, including intent to comply with lifestyle considerations
<br> throughout Study duration.
<br>
<br> 10. Ability to take oral medication and be willing to adhere to the STRI Intervention
<br> Product (STRI Formula or placebo as capsules) regimen.
<br>
<br> 11. Ability to use the internet daily and check email daily.
<br>
<br> 12. Ability and consent to send and receive SMS text messages via cellular phone.
<br>
<br> 13. Provision of information (name, email address, and cellular phone number) of an
<br> emergency contact (e.g., family member/friend/colleague) willing to communicate with
<br> STRI Personnel in case the participant deteriorates.
<br>
<br> 14. Willingness to discontinue any dietary supplement that contains any active ingredient
<br> in STRI Formula (ascorbic acid, cholecalciferol, zinc, copper, quercetin, hesperidin,
<br> caffeic acid, epigallocatechin gallate, bovine lactoferrin) for the duration of the
<br> Study.
<br>
<br> 15. For men and women with child-bearing potential (as defined below), willingness to use
<br> adequate contraception for at least 100 days after beginning the Study.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Inability to comply with study or follow-up procedures, or provide regular updates to
<br> their health status when contacted by the STRI Personnel via email, SMS, or phone.
<br>
<br> 2. Any prior or current hospitalization for COVID-19 or any need for hospitalization for
<br> any reason.
<br>
<br> 3. Any prior or current treatment with any agent for COVID-19.
<br>
<br> 4. Any known allergies or known toxicities to any of the specific ingredients in STRI
<br> Formula (including ascorbic acid, vitamin D, zinc, copper, amla, caffeic acid, coffee,
<br> bovine lactoferrin, milk, quercetin, hesperidin, oranges, citrus fruits, and/or green
<br> tea)
<br>
<br> 5. Body Mass Index > 40 based on participant-reported weight and participant-reported
<br> height.
<br>
<br> 6. Participant-reported weight of less than 35kg.
<br>
<br> 7. Any history of radiation or chemotherapy for cancer within the last 3 months.
<br>
<br> 8. Any history of cardiac arrythmias, hemochromatosis, renal (including any known GFR <
<br> 60mL/min) or hepatic disease (including chronic liver disease).
<br>
<br> 9. Any history of chronic pulmonary disorders
<br>
<br> 10. Any history of any gastrointestinal surgery or disease (including bariatric surgery or
<br> gastrointestinal resection, inflammatory bowel disease, or chronic intestinal
<br> diseases, such as (but not limited to) eosinophilic enteritis or autoimmune
<br> enteritis).
<br>
<br> 11. Any history of mineral or vitamin overload or deficiency (including chronic iron
<br> overload states, copper overload states, or ascorbic acid, vitamin D, zinc, or copper
<br> deficiencies).
<br>
<br> 12. Any history of any adverse event to green tea extract or any herbal products.
<br>
<br> 13. Prescreening Alcohol Use Disorders Identification Test (AUDIT) score of 8 or more
<br> indicating hazardous or harmful alcohol consumption, or alcohol dependence.
<br>
<br> 14. Pregnant or nursing/breastfeeding participants or participants intending to become
<br> pregnant within the next 24 months.
<br>
<br> 15. Men or premenopausal women not using adequate contraception.
<br>
<br> 16. Any other factors as judged by the principal investigator that would cause harm or
<br> increased risk to the participant or preclude the participant's full adherence with or
<br> completion of the study.
<br> | | Covid19 | Drug: STRI Formula;Drug: Placebo | Length of time from treatment initiation to initial meaningful clinical improvement as measured over 30 days. | | | | Yes | False | | |
| → | NCT05047016 | 18 October 2021→15 November 2021 | Study to Evaluate the Dynamic Consent Model Based on the Blockchain-based Clinical Trial Platform METORY | A Virtual Clinical Trial to Implement and Evaluate the Dynamic Consent Model Based on the Blockchain-based Next-generation Clinical Trial Platform METORY | | Seoul National University Hospital | 08/09/2021 | 20210908 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05047016 | Recruiting→Not recruiting | No | N/A | N/A | All | September 13, 2021 | 60 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Basic Science. Masking: None (Open Label). | N/A | Korea, Republic of | ; → | SeungHwan Lee, M.D., Ph.D.;Ki Young Huh, M.D.→SeungHwan Lee, M.D., Ph.D. | | ;zealot648@snu.ac.kr→ | ;82 2 740 8910→ | Seoul National University Hospital;→Seoul National University Hospital |
<br> Inclusion Criteria:
<br>
<br> - Subjects who can use METORY (application platform)
<br>
<br> - Subjects who completely understand the study and voluntarily decide to participate in
<br> the study
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects who are not able to use the web or application due to cognitive dysfunction
<br> or other reasons
<br>
<br> - Subjects who are not able to measure body temperature by themselves
<br>
<br> - Subjects who investigators decide not be appropriate for the study for other reasons
<br> | | COVID-19 Pneumonia | Other: Virtual investigational product | Response time | | | | Yes | False | | |
| → | NCT05048849 | 18 October 2021→15 November 2021 | A Study to Evaluate the Safety, Tolerability, and Immunogenicity of COVID-19 Vaccine, CT-COV-21 Extension Study | A Phase II, Prospective, Open-Label, Multi-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of the COVID-19 Vaccine Candidate MVC-COV1901, CT-COV-21 Extension Study | | Medigen Vaccine Biologics Corp. | 03/09/2021 | 20210903 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05048849 | Not recruiting | No | 20 Years | N/A | All | July 19, 2021 | 500→274 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 2 | Taiwan | ; | Szu-Min Hsieh, MD;Tzou-Yien Lin, MD | | ; | ; | National Taiwan University Hospital;Chang Gang Memorial Hospital, LinKou |
<br> Inclusion Criteria
<br>
<br> 1. Participants who are in the placebo arm of the main study (CT-COV-21), and are
<br> unblinded due to urgent condition other than safety events (i.e. on request from
<br> participants with high risk of acquiring and transmitting infection) after Day 119,
<br> are eligible.
<br>
<br> 2. Female participant must:
<br>
<br> 1. Be either of non-childbearing potential, i.e. surgically sterilized (defined as
<br> having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral
<br> salpingectomy; tubal ligation alone is not considered sufficient) or one year
<br> post-menopausal;
<br>
<br> 2. Or, if of childbearing potential, be abstinent or agree to use medically
<br> effective contraception from 14 days before screening to 30 days following the
<br> last injection of study intervention. Acceptable forms include:
<br>
<br> i. Implanted hormonal methods of contraception or placement of an intrauterine device
<br> or intrauterine system ii. Established use of hormonal methods (injectable, pill,
<br> patch or ring) combined with barrier methods of contraception: condom or occlusive cap
<br> (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository c.
<br> Have a negative pregnancy test
<br>
<br> 3. Participant is willing and able to comply with all required study visits and follow-up
<br> required by this protocol.
<br>
<br> 4. Participant or the participant's legal representative must understand the procedures
<br> of the study and provide written informed consent
<br>
<br> Exclusion Criteria
<br>
<br> 1. Pregnant or breast feeding or have plan to become pregnant in 30 days after last
<br> administration of study intervention.
<br>
<br> 2. Employees at the investigator's site, of the Sponsor or the contract research
<br> organization (CRO) directly involved in the conduct of the study.
<br>
<br> Prior/Concomitant Therapy
<br>
<br> 3. Currently receiving or received any investigational intervention within 30 days prior
<br> to the first dose of study intervention.
<br>
<br> 4. Administered any licensed live-attenuated vaccines within 28 days or other licensed
<br> non-live-attenuated vaccines within 7 days prior to the first dose of study
<br> intervention.
<br>
<br> 5. Administered any blood product or intravenous immunoglobulin administration within 12
<br> weeks prior to the first dose of study intervention.
<br>
<br> 6. Currently receiving or anticipate to receive concomitant immunosuppressive or
<br> immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing
<br> corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone
<br> less than 20 mg or equivalent) within 12 weeks prior to the first dose of study
<br> intervention.
<br>
<br> 7. Currently receiving or anticipate to receive treatment with tumor necrosis factor
<br> (TNF)-a inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to
<br> the first dose of study intervention.
<br>
<br> 8. Major surgery or any radiation therapy within 12 weeks prior to the first dose of
<br> study intervention
<br>
<br> 9. Participant with previous known or potential exposure to SARS-CoV-1 or 2 viruses or
<br> received any other COVID-19 vaccine.
<br>
<br> 10. Participant with a history of hypersensitivity to any vaccine or a history of allergic
<br> disease or reactions likely to be exacerbated by any component of the MVC-COV1901.
<br>
<br> 11. Body (oral, rectal, or ear) temperature = 38.0°C or acute illness (not including minor
<br> illnesses such as diarrhea or mild upper respiratory tract infection at the discretion
<br> of the investigator) within 2 days before the first dose of study intervention.
<br> | | Covid19 Vaccine | Biological: MVC-COV1901(S protein with adjuvant) | Immunogenicity of MVC-COV1901(Neutralizing Antibody);Percentage of Adverse Event (Safety of MVC-COV1901);Number of Adverse Event (Safety of MVC-COV1901) | | | | Yes | False | | |
| +++ | NCT05056883 | 15 November 2021 | A Phase III Confirmatory Study of K-237 | A Phase III Confirmatory Study of K-237-A Multicenter, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial in Patients With Mild COVID-19 | | Kowa Company, Ltd. | 15/09/2021 | 20210915 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05056883 | Recruiting | No | 20 Years | N/A | All | November 12, 2021 | 1000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | Japan | ; | Yuji Yoshikawa;Yuji Hirai | | ctrdinfo@kowa.co.jp; | 81-3-3279-7454; | |
<br> Inclusion Criteria:
<br>
<br> - Persons who meet all of the following criteria will be eligible for this clinical
<br> trial.
<br>
<br> 1. Males and females who are 20 years of age or older at the time of obtaining
<br> consent
<br>
<br> 2. Those who are confirmed positive for SARS-CoV-2 by antigen test or RT-PCR test
<br> using specimens (nasopharynx, nasal cavity, oropharynx, or saliva) collected
<br> within 72 hours prior to obtaining consent.
<br>
<br> 3. Those who have fever symptoms (37.5 degrees Celsius or higher) at the time of
<br> screening test.
<br>
<br> 4. Patients who have at least one symptom with a score of 2 or higher among the
<br> symptoms of myalgia, sore throat, diarrhea, nausea, vomiting, cough, and
<br> shortness of breath at the time of the screening test.
<br>
<br> 5. Patients with a blood oxygen saturation (SpO2) of 96 % or higher during room air
<br> inhalation at the time of the screening test
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects who meet any one of the following criteria will be excluded from this study.
<br>
<br> 1. Patients who have had symptoms caused by COVID-19 for more than 6 days on the day
<br> of initiation of study drug administration (Day 1) with the day of onset of
<br> symptoms as Day 0.
<br>
<br> 2. Patients who need to receive concomitant therapy or administration of prohibited
<br> drugs during the study period
<br>
<br> 3. Patients who have taken or received drugs that have or may have antiviral
<br> activity against SARS-CoV-2 within 2 weeks prior to the start of study drug
<br> administration.
<br>
<br> 4. Patients currently using antiviral drugs
<br>
<br> 5. Patients with suspected complications of infectious diseases other than COVID-19
<br>
<br> 6. Subjects with a history of COVID-19 within 1 month prior to obtaining consent
<br>
<br> 7. Patients whose body weight at the time of screening test is less than 25 kg or
<br> more than 127 kg (the first decimal place of body weight shall be rounded off)
<br>
<br> 8. Patients undergoing dialysis treatment
<br>
<br> 9. Patients wno have severe liver dysfunction (hepatic dysfunction, hepatic
<br> fibrosis, etc.)
<br>
<br> 10. Patients with poorly controlled hypertension (systolic blood pressure (SBP) of
<br> 180 mmHg or higher or diastolic blood pressure (DBP) of 110 mmHg or higher)
<br>
<br> 11. Patients with complications of diabetic retinopathy, diabetic nephropathy, or
<br> diabetic neuropathy
<br>
<br> 12. Patients with heart failure of NYHA Class III or higher
<br>
<br> 13. Patients with malignant tumors or those judged to have a high possibility of
<br> recurrence
<br>
<br> 14. Patients requiring oxygen therapy
<br>
<br> 15. A person who has a complication of methemoglobinemia or any other disease that
<br> may cause measurement error of the pulse oximeter
<br>
<br> 16. Patients with a history of serious drug allergy (anaphylactic shock, etc.)
<br>
<br> 17. Pregnant women, lactating women, or women who plan to become pregnant or lactate
<br> during the study period
<br>
<br> 18. Subjects who have had more than 400 mL of whole blood drawn within 16 weeks or
<br> more than 200 mL within 4 weeks prior to obtaining consent, or component blood
<br> (plasma and platelet components) drawn within 2 weeks
<br>
<br> 19. Patients who have been administered IVM.
<br>
<br> 20. Those who have participated in other clinical trials and received medication at
<br> the time of obtaining consent, or those who have received an investigational drug
<br> other than placebo for less than 16 weeks
<br>
<br> 21. Others who are judged by the investigator or others to be inappropriate to
<br> participate in the study.
<br> | | Covid19 | Drug: K-237 0.3-0.4mg/kg (once daily);Drug: Placebo 0.3-0.4mg/kg (once daily) | Time from the start of study drug administration to 168 hours until the clinical symptoms reach an improving trend | | | | Yes | False | | |
| → | NCT05057221 | 4 October 2021→15 November 2021 | Safety, Tolerability and Efficacy of Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia | A Pilot Study to Assess the Safety, Tolerability and Efficacy of Selectin Inhibitor Uproleselan (GMI-1271) in Patients With COVID-19 Pneumonia | | Lena Napolitano, MD | 23/09/2021 | 20210923 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05057221 | Not recruiting→Recruiting | No | 18 Years | 75 Years | All | September 2021→November 2021 | 15 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1/Phase 2 | United States | ; ; | Lena Napolitano, MD;Jane Wong;Jane Wong | | ;janejw@umich.edu;janejw@umich.edu | ;734-936-4212;734-936-4212 | University of Michigan; |
<br> Inclusion Criteria:
<br>
<br> - Documented COVID-19 pneumonia: defined as upper respiratory tract specimen
<br> (nasopharyngeal swab (NPS) or viral throat swab) positive for COVID-19 and/or imaging
<br> at computed tomography scan suggestive of COVID-19 pneumonia.
<br>
<br> - Confirmed coronavirus (SARS-CoV-2) (positive real-time reverse transcription
<br> polymerase chain reaction test (RT-PCR) for SARS-CoV-2 within 72 hours) enrolled = 48
<br> hours of need for supplemental oxygen.
<br>
<br> - Currently hospitalized requiring supplemental oxygen.
<br>
<br> - Have severe COVID-19 according to the World Health Organization (WHO) Interim Guidance
<br> with confirmation by real-time RT-PCR assay. The enrollment criteria with one of the
<br> following: respiratory distress, respiratory rate (RR) =30 beats/min; oxygen
<br> saturation level less than 93% in resting state; or partial pressure of oxygen
<br> (PaO2)/oxygen concentration (FiO2) = 300 mmHg.
<br>
<br> - Willing and able to participate in all required evaluations and procedures.
<br>
<br> Exclusion Criteria:
<br>
<br> - In the opinion of at least two investigators, unlikely to survive for >48 hours from
<br> screening.
<br>
<br> - Severe chronic respiratory disease (e.g. Chronic obstructive pulmonary disease or
<br> other) requiring supplemental oxygen and/or having required mechanical ventilation
<br> pre-COVID-19 infection.
<br>
<br> - Concurrent enrollment in a COVID related interventional drug trial. Use of remdesivir,
<br> steroids, and convalescent plasma are permitted along with other standard of care
<br> therapies for COVID.37
<br>
<br> - Currently on invasive mechanical ventilation.
<br>
<br> - Hypotension defined as systolic blood pressure < 90 mmHg on two sequential readings at
<br> least 4 hours apart.
<br>
<br> - Total Bilirubin = 3 x upper limit of normal (ULN), Creatinine Clearance = 30
<br> mL/min/1.73m2.
<br>
<br> - Pregnant or breastfeeding.
<br>
<br> - Known diagnosis of an acute thrombosis on admission.
<br>
<br> - Concurrent dual antithrombotic therapy (aspirin or P2Y12 inhibitor plus
<br> anticoagulation to treat deep venous thrombosis or pulmonary embolism (single
<br> antiplatelet or anticoagulant agent at prophylactic dose is permitted).
<br>
<br> - Concomitant use of thrombolytic therapy.
<br>
<br> - Concomitant therapeutic systemic anticoagulant therapy (e.g. heparin, warfarin, direct
<br> thrombin inhibitors and direct factor Xa inhibitors). As per NIH Guidelines:
<br> Hospitalized adults with COVID-19 should receive Venous thromboembolism (VTE)
<br> prophylaxis per the standard of care for other hospitalized adults (AIII).
<br> Anticoagulant or antiplatelet therapy should not be used to prevent arterial
<br> thrombosis outside of the usual standard of care for patients without COVID-19 (AIII);
<br> https://www.covid19treatmentguidelines.nih.gov/therapeutic-management/
<br>
<br> - History of recent major bleeding, defined in accordance with the criteria of the
<br> International Society on Thrombosis and Hemostasis (ISTH).
<br>
<br> - History of bleeding disorder thought to impose excessive bleeding risk as per
<br> investigator discretion
<br>
<br> - Hemodynamic instability, defined as inability to maintain mean arterial pressure.
<br>
<br> - Hypersensitivity to the active substance or to any of the excipients of uproleselan.
<br>
<br> - Any physical examination findings and/or history of any illness that, in the opinion
<br> of the investigator, might confound the results of the study or pose an additional
<br> risk to the patient by their participation in the study
<br> | | COVID-19 Pneumonia | Drug: Uproleselan | Safety of Uproleselan - as measured by serious adverse events;Safety of Uproleselan- as measured by frequency of serious adverse events | | | | Yes | False | | |
| +++ | NCT05060666 | 15 November 2021 | Prophylaxis of COVID-19 Disease With Ivermectin in COVID-19 Contact Persons [German: Prophylaxe Der COVID-19-Erkrankung Mit Ivermectin Bei COVID-19 Kontaktpersonen] | Placebo-controlled Randomized Double-blind Phase III Study on the Efficacy and Safety of Ivermectin Tablets (Driponin®) for the Prophylaxis of COVID-19 Disease in Adult Contact Persons Living in the Household of a Person Suffering From COVID-19 [German: Placebo-kontrollierte Randomisierte Doppel-blinde Phase III Studie Zur Wirksamkeit Und Sicherheit Von Ivermectin Tabletten (Driponin®) für Die Prophylaxe Der COVID-19 Erkrankung Bei im Haushalt Lebenden Erwachsenen Kontaktpersonen Einer an COVID-19 Erkrankten Person] | | Infectopharm Arzneimittel GmbH | 28/09/2021 | 20210928 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05060666 | Not recruiting | No | 18 Years | N/A | All | November 2021 | 412 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 3 | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - age of at least 18 years
<br>
<br> - adult subject living in the same household as a related COVID-19 patient (index
<br> person)
<br>
<br> Exclusion Criteria:
<br>
<br> - index person has COVID-19 symptoms for more than 5 days at enrolment
<br>
<br> - known past COVID-19 or current infection confirmed by positive SARS-CoV-2 PCR test at
<br> enrolment
<br>
<br> - symptoms at enrolment indicating COVID-19: increased body temperature OR acute
<br> respiratory symptoms of any severity OR newly occuring loss of taste or smell OR ague
<br> OR sumulatneously occuring headache and body ache
<br>
<br> - known contraindications to the use of the study medication (in alignemnt with current
<br> summary of product characteristics of Driponin®)
<br>
<br> - known chronic obstructive pulmonary disease
<br>
<br> - known acute or chronic hepatitis B or C or other clinically recognizable or known
<br> liver dysfunction
<br>
<br> - known HIV infection or AIDS
<br>
<br> - known symptomatic allergic rhinitis
<br>
<br> - current (inlcuding up to 24 hours before enrolment) or planned (during next 14 days)
<br> therapy with non-steroidal anti-inflammatory drugs, other pain medication (e.g., ASS
<br> (including prophylactic use), metamizol)
<br>
<br> - recent (up to 28 days before enrolment) or planned (during next 14 days) therapy with
<br> systemic steroids
<br>
<br> - recent (up to 28 days before enrolment) or planned (during next 14 days) therapy with
<br> systemic immunosuppressive drugs
<br>
<br> - known or clinically suspected disturbance of the blood-brain-barrier (e.g., ABCB-1
<br> (=MDR1) mutation) as well as history of neurotoxic effects by ivermectin or other
<br> substrates/inhibitors of the para-glycoprotein (P-gp)
<br>
<br> - known hypersensitivity/intolerance to the study drug or any of its exicpients, in
<br> particular ivermectin, microcrystalline cellulose, pre-agglutinated starch, butyl
<br> hydroxyanisole or magnesium stearate
<br>
<br> - pregnancy or lactation
<br>
<br> - women of child-bearing potential planning to become pregnant or not using effective
<br> mehods of contraception
<br>
<br> - any other severe disorder, which in the opinion of the investigator would preclude the
<br> subject from trial participation
<br>
<br> - previous or planned (during next 14 days) vaccination with any COVID-19 vaccine
<br>
<br> - recent (up to 28 days before enrolment) or planned (during next 14 days) therapy with
<br> Ivermectin
<br>
<br> - recent (up to 28 days before enrolment) or planned (during next 14 days) therapy with
<br> drugs with evident or potential benefit in treating COVID-19 in alignemnt with RKI
<br>
<br> - apparent unreliability or lack of compliance (e.g., not willing to orally administer
<br> the required number of tablets on 2 days or not willing to complete the subject diary
<br> during 14 days)
<br>
<br> - known alcohol or drug abuse
<br>
<br> - participation in another clinical trial during the last 30 days or planned
<br> participation in another clinical trial during the next 30 days
<br>
<br> - previous participation in this same clinical trial
<br> | | Covid19 | Drug: Ivermectin;Drug: Placebo | COVID-19 disease | | | | Yes | False | | |
| → | NCT05062538 | 11 October 2021→15 November 2021 | Cancer Patient Perspectives During COVID→Cancer Patient Perspectives During COVID-19 | Patient Perspectives in Breast Cancer Care During COVID-19 | | University of Colorado, Denver | 29/09/2021 | 20210929 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05062538 | Not recruiting | No | 18 Years | 60 Years | Female | August 24, 2020 | 89 | Observational | | | United States | | Sarah Tevis | | | | University of Colorado Health |
<br> Inclusion Criteria:
<br>
<br> - Adult females with diagnosis of invasive breast cancer or ductal carcinoma in situ,
<br> seen as surgical consultation between 06/01/19-06/01/20
<br>
<br> Exclusion Criteria:
<br>
<br> - Males
<br>
<br> - Patients with non-cancer diagnoses
<br>
<br> - Patients with no history of breast cancer
<br> | | Breast Cancer | | Changes implemented to breast cancer treatment;Treatment concerns during COVID pandemic;Effects of COVID on psychological, social, and physical well-being of breast cancer patients→Number of participants with effects of COVID-19 on psychological, social, and physical well-being of breast cancer patients;Number of participants with treatment concerns during COVID-19 pandemic;Number of participants with changes implemented to breast cancer treatment | | | | No | False | | |
| +++ | NCT05065619 | 15 November 2021 | Safety Immunogenicity Study of MT-2766 in Japanese Adults(COVID-19) | A Phase I/II, Randomized, Placebo-Controlled Study to Evaluate the Safety and Immunogenicity of MT-2766 in Japanese Adults (COVID-19) | | Medicago | 01/10/2021 | 20211001 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05065619 | Recruiting | No | 20 Years | N/A | All | October 2, 2021 | 145 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | Japan | ; | General Manager;Clinical Trials Information Desk, to prevent miscommunication, | | ;cti-inq-ml@ml.mt-pharma.co.jp | ;please email: | Mitsubishi Tanabe Pharma Corporation; |
<br> Inclusion Criteria:
<br>
<br> - Subjects must meet all of the following inclusion criteria at the Screening visit (Visit
<br> 1) and/or 1st vaccination visit (Visit 2) to be eligible for participation in this study.
<br> All Investigator assessment-based judgments must be carefully and fully documented in the
<br> source documents:
<br>
<br> 1. Subjects must have read, understood, and signed the informed consent form (ICF) prior
<br> to participating in the study; subjects must also complete study-related procedures
<br> and must communicate with the study staff at visits and by phone during the study;
<br>
<br> 2. At the Screening visit (Visit 1), Japanese male and female subjects must be =20 years
<br> of age;
<br>
<br> 3. At the Screening visit (Visit 1) and 1st vaccination visit (Visit 2), subject must
<br> have a body mass index (BMI) of =18.5 kg/m^2 and <30 kg/m^2;
<br>
<br> 4. Subjects are considered by the Investigator to be reliable and likely to cooperate
<br> with the assessment procedures and be available for the duration of the study;
<br>
<br> 5. Female subjects of childbearing potential must have a negative serum pregnancy test
<br> result at the Screening visit (Visit 1) and a negative urine pregnancy test result at
<br> 1st vaccination visit (Visit 2):
<br>
<br> Non-childbearing females are defined as:
<br>
<br> - Surgically sterile (defined as bilateral tubal ligation, hysterectomy or
<br> bilateral oophorectomy performed more than one month prior to the first study
<br> vaccination); OR
<br>
<br> - Post-menopausal (absence of menses for 12 consecutive months and age consistent
<br> with natural cessation of ovulation);
<br>
<br> 6. Female subjects of childbearing potential must use an effective method of
<br> contraception for one month prior to 1st vaccination visit (Visit 2) and agree to
<br> continue employing highly effective birth control measures for at least one month
<br> after the last study vaccination (or in the case of early termination, she must not
<br> plan to become pregnant for at least one month after her last study vaccination);
<br>
<br> 7. Subjects must be non-institutionalized (e.g. not living in rehabilitation centers or
<br> old-age homes);
<br>
<br> 8. Subjects have no acute or evolving medical problems prior to study participation and
<br> no clinically relevant abnormalities that could jeopardize subject safety or interfere
<br> with study assessments, as assessed by the Principal Investigator or sub-Investigator
<br> (thereafter referred as Investigator) and determined by medical history, physical
<br> examination, serology, clinical chemistry and hematology tests, urinalysis, and vital
<br> signs. Investigator discretion is permitted with this inclusion criterion.
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects who meet any of the following exclusion criteria at the Screening visit
<br> (Visit 1) and/or 1st vaccination visit (Visit 2) will not be eligible for
<br> participation in this study. All Investigator assessment-based judgments must be
<br> carefully and fully documented in the source documents:
<br>
<br> 1. According to the Investigator's opinion, significant acute or chronic,
<br> uncontrolled medical or neuropsychiatric illness.
<br>
<br> Acute disease is defined as presence of any moderate or severe acute illness with or
<br> without a fever within 48 hours prior to the Screening visit (Visit 1) and/or 1st
<br> vaccination visit (Visit 2).
<br>
<br> 'Uncontrolled' is defined as:
<br>
<br> - Requiring a new medical or surgical treatment during the three months prior to study
<br> vaccine administration;
<br>
<br> - Requiring any significant change in a chronic medication (i.e. drug, dose, frequency)
<br> during the three months prior to study vaccine administration due to uncontrolled
<br> symptoms or drug toxicity unless the innocuous nature of the medication change meets
<br> the criteria outlined in inclusion criterion no. 8 and is appropriately justified by
<br> the Investigator.
<br>
<br> Investigator discretion is permitted with this exclusion criterion. 2. Any confirmed or
<br> suspected current immunosuppressive condition or immunodeficiency, including cancer, HIV,
<br> hepatitis B or C infection (subjects with a history of cured hepatitis B or C infection
<br> without any signs of immunodeficiency at present time are allowed). Investigator discretion
<br> is permitted with this exclusion criterion; 3. Current autoimmune disease (such as
<br> rheumatoid arthritis, systemic lupus erythematosus or multiple sclerosis). Investigator
<br> discretion is permitted with this exclusion criterion. Subjects may be eligible to
<br> participate with appropriate written justification in the source document. For example,
<br> subjects with a history of autoimmune disease who are disease-free without treatment for
<br> three years or more, subjects receiving stable thyroid replacement therapy, and subjects
<br> with mild psoriasis (i.e. a small number of minor plaques requiring no systemic treatment)
<br> are eligible for participation; 4. Administration of any medication or treatment that may
<br> alter the vaccine immune responses, such as:
<br>
<br> - Systemic glucocorticoids at a dose exceeding 10 mg of prednisone (or equivalent) per
<br> day for more than seven consecutive days or for 10 or more days in total, within one
<br> month prior to the 1st vaccination visit (Visit 2). Inhaled, nasal, ophthalmic,
<br> dermatological, and other topical glucocorticoids are permitted;
<br>
<br> - Cytotoxic, antineoplastic, or immunosuppressant drugs - within 36 months prior to 1st
<br> vaccination visit (Visit 2);
<br>
<br> - Any immunoglobulin preparations, blood products, or blood transfusion - within 6
<br> months prior to 1st vaccination visit (Visit 2); 5. Administration of any vaccine
<br> within 14 days prior to 1st vaccination visit (Visit 2); planned administration of any
<br> vaccine during the study (up to Day 28). Immunization on an emergency basis during the
<br> study will be evaluated on case-by-case basis by the Investigator; 6. Administration
<br> of any other SARS-CoV-2/COVID-19 vaccine, or other experimental coronavirus vaccine at
<br> any time prior to or during the study; 7. At screening (Visit 1), subjects found to be
<br> seropositive for prior SARS-COV-2 infection based on N-protein ELISA or positive for
<br> SARS-COV-2 PCR test; 8. Subjects with previous diagnosis of COVID-19 or previous
<br> positive SARS-CoV-2 infection 9. Use of any investigational or non-registered product
<br> within 30 days or 5 half-lives, whichever is longer, prior to 1st vaccination visit
<br> (Visit 2), or planned use during the study period. Subjects who are in a prolonged
<br> post-administration observation period of another investigational or marketed drug
<br> clinical study, for which there is no ongoing exposure to the investigational or
<br> marketed product and all scheduled on-site visits are completed, will be allowed to
<br> take part in this study, if all | | SARS-CoV-2 Infection | Biological: MT-2766 High dose;Drug: Placebo;Biological: MT-2766 Low dose | SARS-CoV-2-specific T helper 2 (Th2) CMI responses;SARS-CoV-2-specific T helper 1 (Th1) cell-mediated immune (CMI) responses;SARS-CoV-2 neutralizing antibody (Nab) responses;The incidences of serious AEs (SAEs), medically attended AEs (MAAEs), AEs leading to withdrawal, AEs of special interest (AESIs), and deaths;The incidences, severity, and investigator-assessed causality of unsolicited AEs;The incidences and severity of the following solicited AEs;The incidences, severity, and investigator-assessed causality of immediate adverse events (AEs) | | | | Yes | False | | |
| → | NCT05067894 | 18 October 2021→15 November 2021 | Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine | A Phase I/II, Observer-Blind, Randomized, Controlled Study of the Safety and Immunogenicity of SARS-CoV-2 Protein Subunit Recombinant Vaccine in Healthy Populations Aged 18 Years and Above in Indonesia | | PT Bio Farma | 01/10/2021 | 20211001 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05067894 | Not recruiting | No | 18 Years | N/A | All | October 2021→November 2021 | 780 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 1/Phase 2 | Indonesia | ; ; | Prof. Rini Sekartini, MD;Rini Mulia Sari, MD;Prof Rini Sekartini, MD | | ;rini.mulia@biofarma.co.id;rsekartini@yahoo.com | ;+6222-2033755;+6221-4894932 | Fakultas Kedokteran Universitas Indonesia; |
<br> Inclusion Criteria:
<br>
<br> 1. Clinically healthy subjects within the following age groups: adults (18-59 years) and
<br> elderly (60 years and above.
<br>
<br> 2. Subjects have been informed properly regarding the study and signed the informed
<br> consent form.
<br>
<br> 3. Subjects will commit to comply with the instructions of the investigator and the
<br> schedule of the trial.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subjects concomitantly enrolled or scheduled to be enrolled in another trial.
<br>
<br> 2. History of vaccination with any investigational product against Covid-19 during or 6
<br> months prior to enrollment.
<br>
<br> 3. Subjects who have history of Covid-19 in the last 3 months (based on anamnesis or
<br> other examinations).
<br>
<br> 4. Evolving mild, moderate or severe illness, especially infectious disease or fever
<br> (body temperature =37.5?, measured with infrared thermometer/thermal gun).
<br>
<br> 5. The result of rapid antigen test is positive.
<br>
<br> 6. Women who are lactating, pregnant or planning to become pregnant during the study
<br> period (judged by self-report of subjects and urine pregnancy test results).
<br>
<br> 7. Abnormality hematology and biochemical test results (for phase I).
<br>
<br> 8. History of asthma, history of allergy to vaccines or vaccine ingredients, and severe
<br> adverse reactions to vaccines, such as urticaria, dyspnea, and angioneurotic edema.
<br>
<br> 9. History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular
<br> injection.
<br>
<br> 10. Patients with serious chronic diseases (serious cardiovascular diseases, uncontrolled
<br> hypertension and diabetes, liver and kidney diseases, malignant tumors, etc) which
<br> according to the investigator might interfere with the assessment of the trial
<br> objectives.
<br>
<br> 11. Subjects who have any history of confirmed or suspected immunosuppressive or
<br> immunodeficient state, or received in the previous 4 weeks a treatment likely to alter
<br> the immune response (intravenous immunoglobulins, blood-derived products or long-term
<br> corticosteroid therapy (> 2 weeks)).
<br>
<br> 12. Subjects who have history of uncontrolled epilepsy or other progressive neurological
<br> disorders, such as Guillain-Barre Syndrome.
<br>
<br> 13. Subjects receive any vaccination (other than Covid-19 vaccine) within 1 month before
<br> and after Investigational Product (IP) immunization.
<br>
<br> 14. Subjects plan to move from the study area before the end of study period.
<br> | | Covid19 | Biological: SARS-CoV-2 Protein Subunit Recombinant Vaccine;Biological: SARS-CoV-2 Inactivated Vaccine | Phase II Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after whole schedule dose;Phase I Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose→Phase I Safety of the SARS-CoV-2 protein subunit recombinant vaccine within 7 days after each dose;Phase II Immunogenicity profile of the SARS-CoV-2 protein subunit recombinant vaccine after whole schedule dose | | | | Yes | False | | |
| → | NCT05067920 | 11 October 2021→15 November 2021 | Correlation Between Cycle Threshold (Ct) Values in COVID-19, Health Status and Laboratory Biomarkers in the Population of Medellin- Colombia Evaluated in a Specialized Laboratory. | Correlation Between Cycle Threshold (Ct) Values in RT-PCR - SARS-CoV-2, Health Status and Laboratory Biomarkers in the Population of Medellin- Colombia Evaluated in a Specialized Laboratory | | Universidad de Antioquia | 09/09/2021 | 20210909 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05067920 | Recruiting | No | 18 Years | 99 Years | All | September 27, 2021 | 120 | Observational [Patient Registry] | | | Colombia | ; ; | Andres F Zuluaga, MD, MSc, MeH;Ivone E Jimenez, PhD(c);Andres F Zuluaga | | ;ivone.jimenez@udea.edu.co; | ;+57 (4) 2196022; | Universidad de Antioquia; |
<br> Inclusion Criteria:
<br>
<br> - People under 18 years old.
<br>
<br> - Covid-19 diagnosis in the last seven days.
<br>
<br> - Specimen analyzed at LIME laboratory
<br>
<br> - Description of symptoms related to COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> - Immunocompromised patients
<br>
<br> - Immunosuppressive treatments, chemotherapy or antiretroviral therapy
<br>
<br> - Anticoagulant therapy
<br>
<br> - Prior immunization for any vaccine in the last 3 months
<br> →
<br> Inclusion Criteria:
<br>
<br> - People under 18 years old.
<br>
<br> - Covid-19 diagnosis in the last seven days.
<br>
<br> - Specimen analyzed at LIME laboratory
<br>
<br> - Description of symptoms related to COVID-19
<br>
<br> Exclusion Criteria:
<br>
<br> - Immunocompromised patients
<br>
<br> - Immunosuppressive treatments, chemotherapy or antiretroviral therapy
<br>
<br> - Outpatient anticoagulation therapy
<br>
<br> - Prior immunization for any vaccine in the last 3 months
<br> | | Covid19 | Diagnostic Test: Levels of SARS-COV-2 antibodies;Diagnostic Test: rRT-PCR SARS-Cov-2;Diagnostic Test: Hematological and immunological biomarkers;Diagnostic Test: Mitochondrial DNA;Diagnostic Test: SARS-CoV-2 Viral Culturing;Diagnostic Test: Sequencing COVID-19 | Clinical immune response among COVID-19 patients related to CT value of rRT-PCR SARS-Cov-2 | | | | Yes | False | | |
| → | NCT05069636 | 18 October 2021→15 November 2021 | Lymphatic Osteopathic Manipulative Medicine to Enhance Coronavirus (COVID-19) Vaccination Efficacy | Lymphatic Osteopathic Manipulative Medicine to Enhance COVID-19 Vaccination Efficacy | | Rowan University | 29/09/2021 | 20210929 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05069636 | Not recruiting | No | 18 Years | N/A | All | October 15, 2021→November 15, 2021 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Single (Participant). | N/A | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Inclusion criteria will include age greater than 18 years old and having safely
<br> received the COVID-19 vaccine.
<br>
<br> Exclusion Criteria:
<br>
<br> - Exclusion criteria will include age under 18 years old, malignancy/cancer, ongoing
<br> infection, coagulopathy history, use of anticoagulant medications, and fracture or
<br> acute injury of the torso neck or upper extremities. Lymphatic OMM is safe during
<br> pregnancy and this does not need to be an exclusion criteria.
<br> | | COVID-19 | Other: Lymphatic OMM;Other: Light Touch | severe acute respiratory syndrome-associated coronavirus 2 (SARS-Cov-2) antibody levels | | | | Yes | False | | |
| → | NCT05074420 | 1 November 2021→15 November 2021 | A Study of Baricitinib (LY3009104) in Children With COVID-19 (COV-BARRIER-PEDS) | A Multicenter, Open-Label, Pharmacokinetic and Safety Study of Baricitinib in Pediatric Patients From 1 Year to Less Than 18 Years Old Hospitalized With COVID-19 | COV-BARRIER | Eli Lilly and Company | 08/10/2021 | 20211008 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05074420 | Not recruiting | No | 2 Years | 18 Years | All | October 22, 2021→November 29, 2021 | 24 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 3 | United States;Belgium;Brazil;India;Mexico;Spain;Belgium;Brazil;India;Mexico;Spain;United States→United States;Spain;Mexico;India;Brazil;Belgium;Spain;Mexico;India;Brazil;Belgium;United States | ; | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST);There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | | ;ClinicalTrials.gov@lilly.com | ;1-317-615-4559 | Eli Lilly and Company; |
<br> Inclusion Criteria:
<br>
<br> - Hospitalized with coronavirus (SARS-CoV-2) infection.
<br>
<br> - Male or female participants from 1 to <18 years of age.
<br>
<br> - Requires supplemental oxygen and have chest imaging findings to confirm respiratory
<br> disease due to COVID-19 within 72 hours of study entry and enrollment.
<br>
<br> Exclusion Criteria:
<br>
<br> - Are receiving biologic treatments (such as Tumor Necrosis Factor [TNF] inhibitors,
<br> interleukin inhibitors, T-cell or B-cell targeted therapies, interferon, or Janus
<br> kinase (JAK) inhibitors); or are receiving other immunosuppressants such that, in the
<br> opinion of the investigator, participating in the study would put the participant at
<br> an unnacceptable risk of immunosuppression.
<br>
<br> Note: A washout period is required prior to screening.
<br>
<br> - Are receiving strong inhibitors of Oranic Anion Transporter 3 (OAT3) (such as
<br> probenecid) that cannot be discontinued at study entry.
<br>
<br> - Have diagnosis of current active tuberculosis (TB) or, if known, latent TB treated for
<br> less than 4 weeks with appropriate anti-tuberculosis therapy per local guidelines (by
<br> history only, no screening tests required).
<br>
<br> - Suspected serious, active bacterial, fungal, viral, or other infection (besides
<br> COVID-19) that in the opinion of the investigator could constitute a risk when taking
<br> investigational product.
<br>
<br> - Have received any live vaccine within 4 weeks before screening, or intend to receive a
<br> live vaccine during the study. Note: Use of non-live (inactivated) vaccinations are
<br> allowed for all participants.
<br>
<br> - Require invasive mechanical ventilation, including extracorporeal membrane oxygenation
<br> (ECMO) at study entry.
<br>
<br> - Current diagnosis of active malignancy that, in the opinion of the investigator, could
<br> constitute a risk when taking investigational product.
<br>
<br> - Have a history of venous thromboembolism (VTE) (deep vein thrombosis [DVT] and/or
<br> pulmonary embolism [PE]) or considered high risk of VTE (DVT/PE).
<br>
<br> - Anticipated discharge from the hospital, or transfer to another hospital (or another
<br> unit), which is not a study site within 72 hours after study entry.
<br>
<br> - Have neutropenia (absolute neutrophil count <1000 cells/microliters).
<br>
<br> - Have lymphopenia (absolute lymphocyte count <200 cells/microliters).
<br>
<br> - Have alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >5 times
<br> AAULN.
<br>
<br> - Estimated glomerular filtration rate (eGFR) (Modification of Diet in Renal Disease
<br> [MDRD]) <40 milliliter/minute/1.73 meters squared.
<br>
<br> - Have a known hypersensitivity to baricitinib or any of its excipients.
<br>
<br> - Are currently enrolled in any other clinical study involving an investigation product
<br> or any other type of medical research judged not to be scientifically or medically
<br> compatible with this study. Note: The participant should not be enrolled (started) in
<br> another clinical trial for the treatment of COVID-19 or SARS CoV-2 through Day 28.
<br>
<br> - Are pregnant, or intend to become pregnant or breastfeed during the study.
<br>
<br> - Are, in the opinion of the investigator or sponsor, at risk of immunosuppression or
<br> otherwise unsuitable for inclusion in the study.
<br>
<br> - Are using or will use extracorporeal blood purification (EBP) device to remove
<br> proinflammatory cytokines from the blood such as a cytokine absorption or filtering
<br> device, for example, CytoSorb®.
<br>
<br> - Are, in the opinion of the investigator, unlikely to survive for at least 48 hours
<br> after screening.
<br> | | Covid19;Corona Virus Infection | Drug: Baricitinib | PK: Maximum Concentration (Cmax) of Baricitinib;Pharmacokinetics (PK): Area Under Concentration Curve (AUC) of Baricitinib | | | | Yes | False | | |
| → | NCT05074433 | 18 October 2021→15 November 2021 | A Study to Evaluate Efficacy and Safety of Casirivimab+Imdevimab (Monoclonal Antibodies) for Prevention of COVID-19 in Immunocompromised Adolescents and Adults | A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Anti-Spike SARS-CoV-2 Monoclonal Antibodies as Pre-Exposure Prophylaxis to Prevent COVID-19 in Immunocompromised Participants | | Regeneron Pharmaceuticals | 08/10/2021 | 20211008 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05074433 | Not recruiting→Recruiting | No | 12 Years | N/A | All | October 15, 2021→October 25, 2021 | 8752 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: Triple (Participant, Care Provider, Investigator). | Phase 3 | →United States;Mexico;United States | ; | Clinical Trial Management;Clinical Trials Administrator | | ;clinicaltrials@regeneron.com | ;844-734-6643 | Regeneron Pharmaceuticals; |
<br> Key Inclusion Criteria:
<br>
<br> 1. Meets =1 of the following criteria:
<br>
<br> - Is immunocompromised, including people with transplant, who have cancer, primary
<br> immunodeficiencies, HIV, rheumatological disease, autoimmune disease, multiple
<br> sclerosis OR
<br>
<br> - Currently taking immunosuppressant drugs
<br>
<br> 2. Have been fully vaccinated against COVID-19 or deemed medically ineligible to receive
<br> full course of vaccine
<br>
<br> 3. Has documented negative serology/antibody response in an anti-SARS-CoV-2 spike protein
<br> IgG clinical test collected =72 hours prior to randomization
<br>
<br> 4. Tested negative for the COVID-19 virus
<br>
<br> Key Exclusion Criteria:
<br>
<br> 1. Weighs <40 kg (only applies to participants =12 to <18 years of age)
<br>
<br> 2. Has any signs or symptoms consistent with COVID-19
<br>
<br> 3. Past COVID-19 infection within 90 days prior to randomization
<br>
<br> 4. Planned use of any investigational, authorized, or approved vaccine for COVID-19
<br> within 90 days of the last dose of study drug
<br>
<br> 5. Prior (within 30 days), current, or planned use of any of COVID-19 convalescent
<br> plasma, other monoclonal antibodies against SARS-CoV-2 or any COVID-19 treatment
<br>
<br> 6. Is planned to begin immunoglobulin (IVIG) or immunoglobulin (SCIG) therapy, is planned
<br> to have a change to existing IVIG or SCIG, or has been on a chronic stable dose of
<br> their IVIG or SCIG regimen for less than 90 days prior to screening
<br>
<br> 7. Has any known active acute respiratory infection
<br>
<br> 8. Has persistent (refractory to treatment for =14 days) bacterial or fungal infection
<br>
<br> 9. Has known allergy or hypersensitivity to components of the study drugs
<br>
<br> NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
<br> | | Immunocompromised | Drug: casirivimab+imdevimab;Drug: Placebo | Cumulative incidence of symptomatic (broad term), RT-PCR-confirmed SARS-CoV-2 infection cases | | | | Yes | False | | |
| → | NCT05075538 | 18 October 2021→15 November 2021 | Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2→COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2 | Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2→COVID-19: Immune Response in Patients With Cancer Undergoing mRNA Vaccination Against SARS-CoV-2 | I-SPARC | Jules Bordet Institute | 07/10/2021 | 20211007 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05075538 | Not recruiting | No | 18 Years | N/A | All | November 2021 | 525 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 4 | Belgium | ; | Evandro DE AZAMBUJA, MD PhD;Angela Loizidou, MD | | evandro.azambuja@bordet.be;angela.loizidou@bordet.be | +3225413662; | |
<br> Inclusion Criteria:
<br>
<br> - Age = 18 years old
<br>
<br> - ECOG performance status = 2
<br>
<br> - Must have histologically or cytologically confirmed cancer diagnosis (invasive solid
<br> tumour or haematological malignancy)
<br>
<br> - currently undergoing active systemic cancer treatment (such as chemotherapy,
<br> immunotherapy, targeted agents, endocrine therapy) in non-metastatic setting or
<br> in metastatic setting (1st line therapy at the time of 1st dose of the
<br> anti-SARS-CoV-2 mRNA vaccine)
<br>
<br> - or currently undergoing follow-up after confirmed cancer complete remission
<br> without active cancer treatment for the last 12 months
<br>
<br> - Life expectancy > 6 months
<br>
<br> - Received 2nd dose of mRNA platform vaccination against SARS-CoV-2 as per local
<br> guidelines within 6 months (maximum until 6 months and 3 weeks) prior to registration.
<br>
<br> - Urine pregnancy test negative for all female subjects of childbearing potential within
<br> 7 days prior to subject enrolment.
<br>
<br> - Signed Informed Consent form (ICF) obtained prior to any study related procedure.
<br>
<br> - Subject is willing and able to comply with the protocol for the duration of the study
<br> including treatment and scheduled visits and examinations.
<br>
<br> Exclusion Criteria:
<br>
<br> - Known pregnant and/or lactating women.
<br>
<br> - Subject with a significant medical, neuro-psychiatric, or surgical condition,
<br> currently uncontrolled by treatment, which, in the principal investigator's opinion,
<br> may interfere with completion of the study.
<br>
<br> - Subjects with active diagnosis of acute leukaemia.
<br>
<br> - Subjects treated with bone marrow transplant < 90 days before received vaccination
<br> against SARS-CoV-2.
<br>
<br> - Subjects with a known history of HIV infection.
<br>
<br> - COVID-19 infection in the last 28 days before receiving first dose of vaccination
<br> against SARS-CoV-2 and up to subject enrolment.
<br>
<br> - Subjects receiving prolonged and/or high doses of systemic immunosuppressive therapies
<br> including corticosteroids during the last 28 days before receiving first dose of
<br> vaccination against SARS-CoV-2 and up to subject enrolment.
<br>
<br> - Subjects who, for any reason, did not receive the 2nd dose of the anti-SARS-CoV-2 mRNA
<br> vaccine.
<br>
<br> - Subjects that received the 3rd dose of anti-SARS-CoV-2 mRNA vaccine prior to study
<br> entry.
<br>
<br> - Subject that received any dose of non-mRNA anti-SARS-CoV-2 vaccine platform.
<br>
<br> - Known prior severe hypersensitivity to anti-SARS-CoV-2 mRNA vaccines or any component
<br> in its formulations.
<br> | | Cancer | Biological: Spikevax→Biological: Spikevax;Biological: Comirnaty | Humoral immune response against SARS-CoV-2 after the second dose of a mRNA anti-SARS-CoV-2 vaccine (Baseline assessment) | | | | Yes | False | | |
| → | NCT05077228 | 26 October 2021→15 November 2021 | Efficiency of the Imaging Strategy for the Management of Suspected Covid-19 | Efficiency of the Imaging Strategy for the Management of Suspected Covid-19 | EFFI-COVID-19 | University Hospital, Strasbourg, France | 11/10/2021 | 20211011 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05077228 | Recruiting→Not recruiting | No | 18 Years | N/A | All | October 1, 2020 | 4000 | Observational | | | France | ; ; → | Sabrina GARNIER KEPKA, MD;Sabrina GARNIER KEPKA, MD;Sabrina GARNIER KEPKA, MD→Sabrina GARNIER KEPKA, MD | | ;Sabrina.GARNIER-KEPKA@chru-strasbourg.fr;Sabrina.GARNIER-KEPKA@chru-strasbourg.fr→ | ;33 3 69 55 13 35;33 3 69 55 13 35→ | Service d'accueil des urgences - Hôpitaux Universitaires de Strasbourg;→Service d'accueil des urgences - Hôpitaux Universitaires de Strasbourg |
<br> Inclusion criteria:
<br>
<br> - Major subject (=18 years old)
<br>
<br> - Subject treated in the emergency rooms of participating centers for suspicion of
<br> COVID-19 presenting with fever> 38 ° and / or respiratory signs (dyspnea, cough,
<br> sputum) and / or other symptoms suggestive of COVID-19 (diarrhea , confusion ...) and
<br> / or people over 85 or living in an institution during the study period from March 9
<br> to May 8, 2020
<br>
<br> - Subject affiliated to a social health insurance protection scheme
<br>
<br> - Subject not having expressed their opposition, after information, to the reuse of
<br> their data for the purposes of this research
<br>
<br> Exclusion criteria:
<br>
<br> - Subject having expressed opposition to participating in the study
<br>
<br> - Subject under guardianship or guardianship
<br>
<br> - Subject under safeguard of justice
<br> | | COVID-19 | | A retrospective study of the imaging strategy for the management of suspected Covid-19 | | | | No | False | | |
| → | NCT05077254 | 26 October 2021→15 November 2021 | COVID Protection After Transplant-Immunosuppression Reduction | A Randomized Study to Evaluate Antibody Response to an Additional Dose of SARS-CoV-2 Vaccination With and Without Immunosuppression Reduction in Kidney and Liver Transplant Recipients | CPAT-ISR | National Institute of Allergy and Infectious Diseases (NIAID) | 12/10/2021 | 20211012 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05077254 | Not recruiting | No | 18 Years | N/A | All | October 15, 2021→November 2021 | 400 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | United States | ; ; | Dorry L. Segev, MD, PhD;Peter S. Heeger, MD;Christian P. Larsen, MD, DPhil | | ;; | ;; | Transplant Surgery, Johns Hopkins University School of Medicine;Translational Transplant Research Center, Icahn School of Medicine at Mount Sinai;Emory Transplant Center, Emory University School of Medicine |
<br> Inclusion Criteria:
<br>
<br> Individuals who meet all the following criteria are eligible for enrollment as study
<br> participants-
<br>
<br> 1. Able to understand and provide informed consent
<br>
<br> 2. Recipient of a kidney or liver transplant =12 months prior to enrollment, without
<br> allograft rejection in the 6 months preceding enrollment
<br>
<br> 3. Negative for anti-donor human leukocyte antigens (HLA) antibodies at screening
<br> (Central Lab Test Determination).
<br>
<br> 4. Currently taking one of the following calcineurin inhibitors (CNI)-based
<br> immunosuppressive regimens:
<br>
<br> - Tacrolimus plus Mycophenolate Mofetil (MMF) or Mycophenolic Acid (MPA), with or
<br> without a corticosteroid
<br>
<br> - Tacrolimus with trough = 5ng/mL with or without =5 mg of prednisone or equivalent
<br>
<br> 5. Received a minimum of 2 doses of either the Moderna coronavirus infectious disease 19
<br> (COVID-19) vaccine or Pfizer-BioNTech COVID-19 vaccine at least 30 days prior to study
<br> entry
<br>
<br> 6. Serum antibody negative or indeterminate (titer <0.8 U/mL) at = 30 days from the last
<br> dose of mRNA COVID-19 vaccine, measured using the Roche Elecsys®) severe acute
<br> respiratory syndrome coronavirus type 2 serological (anti-SARS-CoV-2) S assay, and
<br>
<br> 7. Participant's transplant physician must confirm the participant's eligibility based on
<br> medical history and concur with the plan for immunosuppression modification.
<br>
<br> Exclusion Criteria:
<br>
<br> Individuals who meet any of these criteria are not eligible for enrollment as study
<br> participants-
<br>
<br> 1. Currently on an immunosuppressive regimen different from the three regimens described
<br> in the Inclusion Criteria, for example (but not limited to) those including sirolimus,
<br> everolimus, belatacept, or azathioprine
<br>
<br> 2. Recipient of any allograft other than a kidney or liver
<br>
<br> 3. Participant is pregnant
<br>
<br> 4. Any past history of Donor Specific Antibody (DSA) using local site standards
<br>
<br> 5. Currently taking any systemic immunosuppressive agent, other than their prescribed
<br> transplant immunosuppression
<br>
<br> 6. Recipients of any COVID-19 vaccine other than the Moderna COVID-19 vaccine or the
<br> Pfizer-BioNTech COVID-19 vaccine
<br>
<br> 7. Known history of severe allergic reaction to any component of an authorized or
<br> licensed COVID-19 vaccine
<br>
<br> 8. Thrombotic events, myocarditis, or pericarditis temporally associated with a prior
<br> dose of COVID-19 vaccine
<br>
<br> 9. History of heparin-induced thrombocytopenia
<br>
<br> 10. Any change in transplant immunosuppression regimen (drug or dose) in response to
<br> suspected or proven rejection within the last 6 months
<br>
<br> 11. More than minimal graft dysfunction, in accordance with study definition
<br>
<br> 12. Receipt of any cellular depleting agent (e.g. antithymocyte globulins (ATG),
<br> rituximab, alemtuzumab, Cyclophosphamide) within 12 months preceding enrollment
<br>
<br> 13. Concurrent autoimmune disease at risk for exacerbation with immunosuppression
<br> reduction
<br>
<br> 14. Any untreated active infection including BK viremia >10^4 copies
<br>
<br> 15. Infection with human immunodeficiency virus (HIV)
<br>
<br> 16. Recent (within one year) or ongoing treatment for malignancy with the exception of:
<br>
<br> - Non- melanomatous skin cancer definitively treated by local therapy, and
<br>
<br> - Definitively treated carcinoma-in-situ of the cervix (Stage 0 cervical cancer)
<br>
<br> 17. Treatment or prophylaxis of COVID-19 with a monoclonal antibody product or
<br> convalescent plasma within 6 months preceding enrollment, or
<br>
<br> 18. Any past or current medical problems, treatments, or findings which, in the opinion of
<br> the investigator, may:
<br>
<br> - pose additional risks from participation in the study,
<br>
<br> - interfere with the candidate's ability to comply with study requirements, or
<br>
<br> - impact the quality or interpretation of the data obtained from the study.
<br> | | Kidney Transplant Recipients;Liver Transplant Recipients | Biological: Pfizer-BioNTech COVID-19 Vaccine Booster;Biological: Moderna COVID-19 Vaccine Booster;Drug: SOC IS Regimen;Drug: SOC IS Reduction | Proportion of Participants Who Achieve an Antibody Response >50 U/mL | | | | Yes | False | | |
| → | NCT05077917 | 1 November 2021→15 November 2021 | Cromolyn Sodium for Treatment of COVID-19 Pneumonia | Cromolyn Sodium for Treatment of COVID-19 Pneumonia | | Texas Tech University Health Sciences Center, El Paso | 08/10/2021 | 20211008 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05077917 | Not recruiting | No | 18 Years | 80 Years | All | October 2021→November 2021 | 60 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 3 | United States | ; ; | Edward A Michelson, MD;Susan Watts, PhD;Danielle Austin | | ;Susan.Watts@ttuhsc.edu;danielle.austin@ttuhsc.edu | ;(915) 215-4633;915-215-4648 | Texas Tech University Health Sciences Center, Department of Emergency Medicine; |
<br> Inclusion Criteria:
<br>
<br> 1. COVID-19 symptoms (fever, cough, sore throat, malaise, headache, muscle pain, dyspnea
<br> at rest or with exertion, confusion, or respiratory distress),
<br>
<br> 2. diagnosis of COVID-19 pneumonia with an admission chest x-ray demonstrating multilobar
<br> ground glass infiltrates consistent with COVID-19 pneumonia.
<br>
<br> 3. room air estimated PaO2/FiO2 ratio between 150 -280
<br>
<br> 4. must correct to a pulse oximetry of 90% or better using no more than 5 liters of low
<br> flow supplemental oxygen
<br>
<br> 5. must be enrolled within 24 hours of hospital admission
<br>
<br> Exclusion Criteria:
<br>
<br> 1. immunocompromised due to current use of immunosuppressive drugs or chemotherapy, have
<br> a history of HIV/organ transplant/ active hepatitis B or C, or are on hemodialysis or
<br> peritoneal dialysis
<br>
<br> 2. currently on oxygen supplementation greater than low flow nasal cannula (including
<br> home oxygen therapy; CPAP for obstructive sleep apnea is not an exclusion)
<br>
<br> 3. have DNR status or not expected to survive >7 days
<br>
<br> 4. experiencing shock (on vasopressors) or multiple organ dysfunction or failure
<br>
<br> 5. are co-infected with influenza A or B
<br>
<br> 6. history of DVT or PE within last 12 weeks
<br>
<br> 7. currently pregnant or nursing
<br>
<br> 8. participating in another therapeutic trial
<br>
<br> 9. allergic to cromolyn sodium.
<br> | | COVID-19 Pneumonia;COVID-19 Respiratory Infection;Pneumonia, Viral | Drug: Cromolyn Sodium;Other: Placebo | Change in requirement for oxygen supplementation based on daily assessment of flow (LPM or %Fi O2) and delivery device (cannula, mask, CPAP/BiPAP, ventilator);Change in respiratory symptoms (cough, shortness of breath, and fatigue) determined by data extraction from medical record, self-assessment by subject, or subject survey as appropriate for stage of the study. | | | | Yes | False | | |
| → | NCT05084976 | 1 November 2021→15 November 2021 | Parental Perception of COVID 19 Vaccine in Technology Dependent Patients→Parental Perception of COVID-19 Vaccine in Technology Dependent Patients | Parental Perception of COVID 19 Vaccine in Pediatric Patients With Tracheostomy and Ventilator Dependence→Parental Perception of COVID-19 Vaccine in Pediatric Patients With Tracheostomy and Ventilator Dependence | | Northwell Health | 18/10/2021 | 20211018 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05084976 | Recruiting | No | N/A | 21 Years | All | September 23, 2021 | 60 | Observational | | | United States | ; ; | Karen Capusan, MSN;Karen Capusan, MSN;Karen Capusan, MSN | | ;kchu7@northwell.edu;kchu7@northwell.edu | ;5163218680;516-321-8680 | Northwell Health; |
<br> Inclusion Criteria:
<br>
<br> - Mother or father of child will be interviewed
<br>
<br> - Pediatric patient (age 0-21)
<br>
<br> - "Technology dependent" with one or more of the following: tracheostomy, ventilator
<br> use, non-invasive mechanical ventilator use (BiPAP, CPAP, Airvo), diaphragmatic
<br> pacing, oxygen
<br>
<br> Exclusion Criteria:
<br>
<br> - Other caretakers such as grandparents, aunts, uncles
<br> | | Chronic Respiratory Failure;Tracheostomy Complication;Mechanical Ventilation Complication | Behavioral: COVID 19 vaccine counseling | Percentage of pediatric patient getting COVID 19 vaccine | | | | Yes | False | | |
| → | NCT05087381 | 1 November 2021→15 November 2021 | Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community | Randomized-controlled Trial of the Effectiveness of COVID-19 Early Treatment in Community With Fluvoxamine, Bromhexine, Cyproheptadine, and Niclosamide in Decreasing Recovery Time | | Chulalongkorn University | 19/10/2021 | 20211019 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05087381 | Recruiting | No | 18 Years | N/A | All | October 1, 2021 | 1800 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 4 | Thailand | ; ; ; ; ; ; | Dhammika Leshan Wannigama, MD PhD;Cameron Hurst, PhD;Kanokpoj Chanpiwat, MD;Shuichi Abe, MD;Katika Akksilp, MD;Dhammika Leshan Wannigama, MD PhD;Dhammika Leshan Wannigama, MD PhD | | ;;;;;Dhammika.L@chula.ac.th;Dhammika.L@chula.ac.th | ;;;;;+66970212302;66970212302 | Chulalongkorn University;QIMR Berghofer Medical Research Institute;Rajvithi Hospital;Yamagata Prefectural Central Hospital;Ministry of Health, Thailand; |
<br> Inclusion Criteria:
<br>
<br> - COVID-1 9 patients with mild symptoms and the results were confirmed by Antigen Test
<br> Kit or PCR for SARS-CoV-2.
<br>
<br> - People who have symptoms consistent with COVID-19 and test positive for SARS-CoV-2
<br> infection within 7 2 hours of being known.
<br>
<br> - Participants are 18 years of age or older.
<br>
<br> Exclusion Criteria:
<br>
<br> - Almost recovered (generally much improved and symptoms now mild or almost absent)
<br>
<br> - Judgement of the recruiting clinician deems ineligible.
<br>
<br> - Previous randomisation to an arm of the trial
<br>
<br> - Pregnancy
<br>
<br> - Breastfeeding
<br>
<br> - Known severe hepatic impairment.
<br>
<br> - Known severe renal impairment.
<br>
<br> - Currently taking Fluvoxamine, Bromhexine, Cyproheptadine, or Niclosamide
<br> →
<br> Inclusion Criteria:
<br>
<br> - COVID-1 9 patients with mild symptoms and the results were confirmed by Antigen Test
<br> Kit or PCR for SARS-CoV-2.
<br>
<br> - People who have symptoms consistent with COVID-19 and test positive for SARS-CoV-2
<br> infection within 48 hours of being known.
<br>
<br> - Participants are 18 years of age or older.
<br>
<br> Exclusion Criteria:
<br>
<br> - Almost recovered (generally much improved and symptoms now mild or almost absent)
<br>
<br> - Judgement of the recruiting clinician deems ineligible.
<br>
<br> - Previous randomisation to an arm of the trial
<br>
<br> - Pregnancy
<br>
<br> - Breastfeeding
<br>
<br> - Known severe hepatic impairment.
<br>
<br> - Known severe renal impairment.
<br>
<br> - Currently taking Fluvoxamine, Bromhexine, Cyproheptadine, or Niclosamide
<br> | | Treatment Efficacy | Drug: FluvoxaMINE Maleate 50 MG;Combination Product: Fluvoxamine, Bromhexine;Combination Product: Fluvoxamine, Cyproheptadine;Drug: Niclosamide Pill;Combination Product: Niclosamide, Bromhexine | Hospital admission or mortality related to COVID-19;Time taken to self- report recovery;Progression to severe COVID-19 Disease→Progression to severe COVID-19 Disease;Time taken to self- report recovery;Hospital admission or mortality related to COVID-19 | | | | Yes | False | | |
| → | NCT05089305 | 1 November 2021→15 November 2021 | Ozone Plasma on Lung Function and Inflammatory Parameters in Pulmonary Sequelae Associated With Coronavirus 19 Infection | Effect of Inhalation Administration of Ozone Plasma on Lung Function and Inflammatory Parameters in Patients With Pulmonary Sequelae Associated With Coronavirus 19 Infection (SARS-COV-2) | | Centro Universitario de Ciencias de la Salud, Mexico | 14/10/2021 | 20211014 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05089305 | Recruiting | No | 25 Years | 80 Years | All | October 4, 2021→September 4, 2021 | 35 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | Mexico | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Men and women
<br>
<br> - 25-80 years
<br>
<br> - Individuals without active disease with previous confirmed diagnosis of COVID-19
<br> infection with negative nasopharyngeal PCR test
<br>
<br> - With characteristic chest radiographic images compatible with lung infection,
<br> particularly interstitial pneumonitis with previous unburied glass patches,
<br> cobblestone or areas of consolidation (during active disease)
<br>
<br> - Sign a letter of consent under information
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients taking the following medicines: Ivermectin, azithromycin, corticosteroids,
<br> colchicine, chlorine dioxide, oral anticoagulants such as acenocoumarin, apixaban,
<br> rivaroxaban; bronchodilators such as ß2-agonists such as salbutamol and derivatives,
<br> as well as inhaled anticholinergics of the ipratropium bromide type and derivatives.
<br>
<br> - Patients who present medical difficulty or contraindication to perform the 6 km walk
<br> test in band
<br>
<br> - Patients with a history of community-acquired pneumonia, pulmonary neoplasms, heart,
<br> renal, or hepatic failure
<br> | | COVID-19 | Drug: Ozone plasma | Lung Function;Inflammatory parameters→Inflammatory parameters;Lung Function | | | | Yes | False | | |
| → | NCT05091723 | 26 October 2021→15 November 2021 | TD-0903 Pharmacokinetics Study in Healthy Participants With Supplemental Oxygenation | Phase 1, Open-label Study to Assess the Pharmacokinetics and Safety of Inhaled Nezulcitinib (TD-0903) Administered in the Setting of Supplemental Oxygenation Scenarios in Healthy Participants | | Theravance Biopharma | 12/10/2021 | 20211012 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05091723 | Not recruiting→Recruiting | No | 18 Years | 65 Years | All | October 2021→October 13, 2021 | 14 | Interventional | Allocation: Non-Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 1 | →United States | ; | Medical Monitor;Medical Monitor | | ;medinfo@theravance.com | ;1-855-633-8479 | Theravance Biopharma; |
<br> Inclusion Criteria:
<br>
<br> - Body mass index (BMI) = 18.0 and = 35.0 kg/m2 and weighs at least 50 kg at screening
<br>
<br> - Medically healthy with no clinically significant medical history, physical
<br> examination, spirometry, laboratory profiles, vital signs or ECGs
<br>
<br> - Forced expiratory volume of 1 second (FEV1) =80% predicted at screening and prior to
<br> dosing
<br>
<br> - No clinically significant abnormalities in the results of laboratory
<br>
<br> - Female subjects must be either of non-childbearing potential or if of childbearing
<br> potential, subject must not be pregnant or breastfeeding, and must agree to use a
<br> highly effective birth control method
<br>
<br> - Male subjects must agree to use condoms to prevent potential fetal or partner exposure
<br> through seminal fluid, in addition to the use of highly effective pregnancy prevention
<br> measures with female partners of childbearing potential
<br>
<br> - Able to understand the correct technique for the use of the nebulizer device
<br>
<br> - Other inclusion criteria apply
<br>
<br> Exclusion Criteria:
<br>
<br> - History or presence of clinically significant medical or psychiatric condition
<br>
<br> - Abnormal ECG measurements at screening
<br>
<br> - Any signs of respiratory tract infection within 6 weeks of screening
<br>
<br> - Has a current bacterial, parasitic, fungal, or viral infection; any infection
<br> requiring hospitalization or intravenous antibiotics within 6 months prior to
<br> screening
<br>
<br> - Has any condition of the oro-laryngeal or respiratory tract
<br>
<br> - History or presence of alcoholism or drug abuse
<br>
<br> - Positive urine drugs of abuse test
<br>
<br> - Positive urine or breath alcohol results
<br>
<br> - Uses or has used tobacco or nicotine-containing products (e.g., cigarettes, cigars,
<br> chewing tobacco, snuff, patches etc.) within 6 months prior to screening
<br>
<br> - Tests positive for active COVID-19
<br>
<br> - Additional exclusion criteria apply
<br> | | Acute Lung Injury (ALI) Due to Coronavirus Disease-2019 (COVID-19) | Drug: Nezulcitinib (TD-0903) Dose A;Drug: Nezulcitinib (TD-0903) Dose B | Cmax;AUC0-t;AUC0-inf→AUC0-inf;AUC0-t;Cmax | | | | Yes | False | | |
| → | NCT05092698 | 1 November 2021→15 November 2021 | The Efficacy of Vitamin D Supplementation in Patients With Severe and Extremely Severe COVID-19 | The Efficacy of Vitamin D Supplementation in Patients With Severe and Extremely Severe COVID-19 | COVID-VIT | Federal Research Clinical Center of Federal Medical & Biological Agency, Russia | 22/10/2021 | 20211022 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05092698 | Recruiting | No | 18 Years | 100 Years | All | May 1, 2020 | 100 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Care Provider). | N/A | Russian Federation | ; ; | Tatiana V Klypa, ScD;Mikhail V Bychinin, PhD;Mikhail V Bychinin, PhD | | ;drbychinin@gmail.com;drbychinin@gmail.com | ;+7 926 217-99-72;+7 926 217-99-72 | Federal Research Clinical Center of Federal Medical & Biological Agency; |
<br> Inclusion Criteria:
<br>
<br> - all patients with COVID-19 admitted to the ICU with vitamin D deficiency
<br> [25-hydroxyvitamin D (25(OH)D) = 30 ng/ml]
<br>
<br> Exclusion Criteria:
<br>
<br> - less than 24 hours in ICU by any reason
<br>
<br> - chronic decompensated disease with extrapulmonary organ dysfunction (tumour
<br> progression, liver cirrhosis, congestive heart failure) with a life expectancy of less
<br> than 48 hours
<br>
<br> - atonic coma
<br>
<br> - allergic reaction on cholecalciferol or herbal oil
<br> | | SARS-CoV2 Infection | Dietary Supplement: Vitamin D (cholecalciferol) | Proinflamatory markers;Proinflamatory markers dynamics 1;Proinflamatory markers dynamics 2;Proinflamatory markers dynamics 3;Proinflamatory markers dynamics 4;Immunogram;Von Willebrand factor antigen;Thrombotic complications;Immunogram→?omplete blood count;Infection marker 1;Infection marker;inflammatory marker 3;inflammatory marker 2;inflammatory marker 1;inflammatory marker;Proinflammatory marker 3;Proinflammatory marker 2;Proinflammatory marker 1;Proinflammatory marker;Immunogram;Thrombotic complications;Von Willebrand factor antigen;C-reactive protein 3;C-reactive protein 2;C-reactive protein 1;C-reactive protein;?omplete blood count dynamics 3;?omplete blood count dynamics 2;?omplete blood count dynamics 1 | | | | No | False | | |
| → | NCT05094622 | 1 November 2021→15 November 2021 | Physical Training in Patients With POTS After Covid-19 | Physical Exercise in Patients With Postural Orthostatic Tachycardia Syndrome (POTS) (ReCOV) | POTS-ReCOV | Karolinska Institutet | 25/10/2021 | 20211025 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05094622 | Not recruiting | No | 18 Years | N/A | All | October 2021→November 2021 | 30 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Sweden | ; ; | Malin Nygren Bonnier, PhD;Malin Nygren Bonnier, PhD;Malin Nygren-Bonnier, PhD | | ;malin.nygren-bonnier@ki.se;malin.nygren-bonnier@ki.se | ;+4685248831; | Karolinska Institutet; |
<br> Inclusion Criteria: Patients diagnosed with postural orthostatic tachycardia syndrome
<br>
<br> Exclusion Criteria: patient not able to perform the intervention due to cognitive or
<br> physical dysfunction, ongoing physical intervention.
<br> | | Covid19;Post-acute Covid-19 Syndrome;Postural Orthostatic Tachycardia Syndrome | Other: Physical exercise program | Change in Health-Related Quality of Life (HRQoL);Change in time in upright position→Change in time in upright position;Change in Health-Related Quality of Life (HRQoL) | | | | Yes | False | | |
| → | NCT05096052 | 1 November 2021→15 November 2021 | PROlectin M, a Nucleocapsid TErminal GaleCTin Antagonist for COVID-19 | PROlectin M, a Nucleocapsid TErminal GaleCTin Antagonist for COVID-19 (PROTECT), a Randomized, Double-blinded, Placebo-controlled Clinical Trial to Evaluate the Efficacy and Safety Among Asymptomatic to Moderately-severe, Ambulatory Patients. | PROTECT | Pharmalectin Inc→Bioxytran Inc. | 21/10/2021 | 20211021 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05096052 | Not recruiting | No | 18 Years | N/A | All | December 1, 2021 | 408 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | | | ALBEN SIGAMANI, MD | | dralbens@myrescon.com | 00918884431444 | |
<br> Inclusion Criteria:
<br>
<br> - 1. Male or Female patient of = 18 years of age, willing and able to provide written
<br> informed consent for participation in the study and ready to comply with the study
<br> procedures and schedule.
<br>
<br> 2. Patient having a positive diagnosis for presence of SARS-CoV-2, obtained from a
<br> recently performed rRT-PCR (= 3 days) with any 1 of the following: i. Ct value = 25
<br> ii. Hospitalized for having classical (CDC defined) symptoms of COVID-19 (onset = 5
<br> days) iii. High risk category of COVID-19: blood group type A-positive type 2
<br> diabetes, or other chronic disease known to have higher morbidity risk with SARS-CoV-2
<br> infection.
<br>
<br> 3. Patient has the ability to take oral medication and be willing to adhere to the
<br> trial protocol regimen of repeated swab collections and frequent follow up for 29
<br> days.
<br>
<br> 4. Females of child bearing potential who has been using a highly effective
<br> contraception for at least 1 month prior to screening and agrees to continue using it
<br> during the study participation/enrolment, confirmed through negative pregnancy test
<br>
<br> Exclusion Criteria:
<br>
<br> - 5. Oxygen Saturation levels (SpO2) = 94% on room air. 6. Female patients who are
<br> pregnant or breastfeeding. 7. Patients with any active malignancy or undergoing active
<br> chemotherapy. 8. Patients who are currently receiving or have received any
<br> investigational treatment for COVID-19 within 30 days prior to screening.
<br>
<br> 9. In the opinion of the Investigator, the participation of the patient in the study
<br> is not in the patient's best interest, or the patient has any medical condition that
<br> does not allow the study protocol to be followed safely.
<br>
<br> 10. Patients with known allergies to any of the components used in the formulation of
<br> the interventions.
<br> | | COVID-19;COVID-19 Pandemic;COVID-19 Respiratory Infection;SARS-CoV2 Infection;Cytokine Release Syndrome | Drug: Galactomannan;Drug: PLACEBO | Change in seropositivity from baseline for-detection of viral shedding;Change in clinical status from baseline | | | | Yes | False | | |
| → | NCT05096091 | 1 November 2021→15 November 2021 | International Study on COVID-19 Vaccine to Assess Immunogenicity, Reactogenicity and Efficacy (InVITE) | International Study on COVID-19 Vaccine to Assess Immunogenicity, Reactogenicity and Efficacy (InVITE) | InVITE | National Institute of Allergy and Infectious Diseases (NIAID) | 26/10/2021 | 20211026 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05096091 | Recruiting | No | 18 Years | N/A | All | August 16, 2021 | 3000 | Observational | | | Congo, The Democratic Republic of the;Guinea;Indonesia;Liberia;Mali;Mexico;Congo, The Democratic Republic of the;Guinea;Indonesia;Liberia;Mali;Mexico | ; → ; ; ; | Renee Ridzon, MD;Sally Hunsberger, PhD→Renee Ridzon, MD;Irini Sereti, MD;Sally Hunsberger, PhD;Sally Hunsberger, PhD | | ;sally.hunsberger@nih.gov→;;;sally.hunsberger@nih.gov | ;240-699-5257→;;;240-699-5257 | National Institute of Allergy and Infectious Diseases (NIAID);→National Institute of Allergy and Infectious Diseases (NIAID);National Institute of Allergy and Infectious Diseases (NIAID);National Institute of Allergy and Infectious Diseases (NIAID); |
<br> Inclusion Criteria:
<br>
<br> - 18 years of age or older.
<br>
<br> - Ability to provide informed consent.
<br>
<br> - Enrollment within one day (before or after) of receipt of COVID-19 vaccine.
<br>
<br> - Willingness to be evaluated (including collection of blood and nasopharyngeal samples)
<br> during the prescribed study visits and/or during acute illness consistent with
<br> SARS-CoV-2 infection during the study period.
<br>
<br> - Willingness to allow storage of biological samples for research testing as outlined in
<br> this protocol.
<br>
<br> Exclusion Criteria:
<br>
<br> - Any acute or chronic condition that, in the opinion of the investigator, is a
<br> contraindication to participation in this study; for example, acute febrile illness.
<br>
<br> - Inability to comply with study visits.
<br> | | COVID-19 | | 1. To characterize immunogenicity (by measurement of anti-Spike [S] antibody [Ab]) of available COVID-19 vaccines in the overall study population, in each of the countries and in defined subgroups | | | | Yes | False | | |
| → | NCT05096962 | 1 November 2021→15 November 2021 | SARS-CoV-2-CZ-PREVAL-II Study→COVID-19: SARS-CoV-2-CZ-PREVAL-II Study | SARS-CoV-2-CZ-PREVAL-II Study | | Institute of Health Information and Statistics of the Czech Republic | 22/10/2021 | 20211022 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05096962 | Recruiting | No | 18 Years | N/A | All | September 13, 2021 | 9300 | Observational | | | Czechia | ; ; ; ; | Marián Hajdúch, Assoc. Prof.;Vera Adámková, Prof.;Markéta Ibrahimová, Ph.D.;Barbora Macková, M.D.;Ladislav Dušek, Prof. | | ;;;; | ;;;; | Institute of Molecular nad Translational Medicine;Institute for Clinical and Experimental Medicine;Thomayer University Hospital;The National Institute of Public Health;Institute of Health Information and Statistics of the Czech Republic |
<br> Inclusion Criteria:
<br>
<br> - signed Informed consent
<br>
<br> - willingness to complete the study questionnaire
<br>
<br> - demographic criteria - age 18 years old and more
<br>
<br> - clinical criteria - without acute health problems
<br>
<br> - time criteria - sample collection in the defined time period
<br>
<br> Exclusion Criteria:
<br>
<br> - none
<br> →
<br> Inclusion Criteria:
<br>
<br> - signed Informed consent
<br>
<br> - willingness to complete the study questionnaire
<br>
<br> - demographic criteria - age 18 years old and more
<br>
<br> - clinical criteria - without acute health problems
<br>
<br> - time criteria - sample collection in the defined period time
<br>
<br> Exclusion Criteria:
<br>
<br> - none
<br> | | COVID-19;SARS-CoV-2 Infection | Diagnostic Test: Quantitative analysis of SARS-CoV-2 antibodies;Diagnostic Test: Cellular immunity | Detection of a number of subjects with IgG anti-SARS-CoV-2 antibodies | | | | Yes | False | | |
| +++ | NCT05102630 | 15 November 2021 | Ventilator Strategies in ICU Patients With COVID-19 - a National-wide Retrospective Observational Study. | The Use of Mechanical Ventilation Strategies and Its Potential Adverse Events Among ICU Patients With COVID-19 - a National-wide Retrospective Observational Study. | | University of Southern Denmark | 29/10/2021 | 20211029 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05102630 | Recruiting | No | N/A | N/A | All | June 1, 2021 | 1193 | Observational [Patient Registry] | | | Denmark | ; | Anne C Brøchner, MD, PhD;Anne C Brøchner, MD, Ph D | | ;anne.craveiro.broechner@rsyd.dk | ;+4529464468 | University of Southern Denmark; |
<br> Inclusion Criteria:
<br>
<br> All mechanical ventilated patients registered in the national Danish COVID ICU database
<br> between 10.03.2020 - 02.04.2021 i.e.
<br>
<br> 1. Admitted to an ICU in Denmark
<br>
<br> 2. Laboratory-confirmed SARS-CoV-2 infection
<br>
<br> 3. Use of invasive mechanical ventilation (ventilation via a cuffed endotracheal tube) at
<br> any time during the ICU stay
<br>
<br> Exclusion Criteria:
<br>
<br> None
<br> | | ARDS Due to COVID-19 | | Ventilator days with lung -protective ventilation in percent of all ventilation days with 95%-CI. | | | | Yes | False | | |
| +++ | NCT05102669 | 15 November 2021 | Spike-specific Cellular Immune Response After COVID-19 Vaccination | Spike-specific Cellular Immune Response After COVID-19 Vaccination | RIS-COV | IRCCS San Raffaele Roma | 28/10/2021 | 20211028 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05102669 | Not recruiting | No | 18 Years | N/A | All | March 12, 2021 | 53 | Observational | | | Italy | | Laura Vitiello, PhD | | | | IRCCS San Raffaele Roma |
<br> Inclusion Criteria:
<br>
<br> - vaccinated and non vaccinated subjects
<br>
<br> - subjects that never tested positive for COVID19
<br>
<br> Exclusion Criteria:
<br>
<br> - subjects that tested positive for COVID-19
<br> | | COVID19;Vaccination;Immune Response | Other: analysis of immunological response;Diagnostic Test: analysis of serum antibodies | measurement of cellular response | | | | Yes | False | | |
| +++ | NCT05102708 | 15 November 2021 | Study of COVID-19 Prognostic Factors in Hospitalized Patients | Study of COVID-19 Prognostic Factors in Hospitalized Patients | | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau | 27/10/2021 | 20211027 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05102708 | Not recruiting | No | 18 Years | N/A | All | November 1, 2021 | 4000 | Observational | | | Spain | ; ; | Teresa Puig, MD, PhD, MSC;Teresa Puig, MD, PhD, MSC;Teresa S Puig, MD, PhD, MSC | | ;tpuig@santpau.cat;tpuig@santpau.cat | ;+34935537808;+34935537808 | Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau; |
<br> Inclusion Criteria:
<br>
<br> - Equal or older than 18 years old
<br>
<br> - Hospitalized between March 1st, 2020, and February 28th, 2021.
<br>
<br> - Be diagnosed with COVID-19 disease
<br>
<br> Exclusion Criteria:
<br>
<br> - Underaged patients
<br>
<br> - > 16h stay in the Emergency Unit
<br> | | COVID-19 | Other: Prognostic factors of severe COVID-19 | All cause mortality;Critical care admission;Length of stay;30-day all cause mortality | | | | Yes | False | | |
| +++ | NCT05104346 | 15 November 2021 | Presentation and Outcomes of Acute Appendicitis During COVID Pandemic | Presentation and Outcomes of Acute Appendicitis During COVID Pandemic: Lessons Learned From the Middle East (Multicenter Study) | AA | Mansoura University | 31/10/2021 | 20211031 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104346 | Not recruiting | No | 12 Years | N/A | All | March 31, 2019 | 1945 | Interventional | Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | N/A | Egypt | | Ayman El E El Nakeeb | | | | Mansoura University, Gastrointestinal Surgery Center |
<br> Inclusion Criteria:
<br>
<br> patients with acute appendicitis
<br>
<br> Exclusion Criteria:
<br>
<br> - patients with acute appendicitis less than 12 years
<br>
<br> - malignant appendix
<br> | | Acute Appendicitis | Procedure: appendectomy | the management strategy used | | | | No | False | | |
| +++ | NCT05104359 | 15 November 2021 | COVID-19 Quantitative Antibody Titers & Booster Vaccinations | Should COVID-19 Quantitative Antibody Titers be Implemented to Guide COVID-19 Booster Vaccinations Regardless of HIV Status, Immunosuppression, or Age? | | Epividian | 01/11/2021 | 20211101 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104359 | Not recruiting | No | 18 Years | N/A | All | December 11, 2020 | 500 | Observational | | | United States | | Ricky Hsu, MD | | | | AHF Midtown Manhattan |
<br> Inclusion Criteria:
<br>
<br> - Cared for at AHF Midtown Manhattan Healthcare Center and followed in the OPERA
<br> observational database
<br>
<br> - Active in care in the last 24 months
<br>
<br> - Fully vaccinated against SARS-CoV-2 virus, implemented as 21 days after the second
<br> Pfizer or Moderna injections, 21 days after the one J&J injection
<br>
<br> - Received a Roche SARS-CoV-2 Semi-Quant Spike Ig AB test after full vaccination as
<br> usual clinical care
<br>
<br> Exclusion Criteria:
<br>
<br> - Unvaccinated or partially vaccinated against SARS-CoV-2 virus
<br>
<br> - Never tested with a SARS-CoV-2 Semi-Quant Total AB test after full vaccination
<br> | | COVID-19;COVID-19 Vaccines;Immunogenicity, Vaccine | Other: Observational | Vaccine Response | | | | No | False | | |
| +++ | NCT05104372 | 15 November 2021 | Hypertonic Saline Nasal Irrigation and Gargling (HSNIG) for Suspected COVID-19 in Pakistan | Hypertonic Saline Nasal Irrigation and Gargling (HSNIG) for Suspected COVID-19: Pragmatic, Web-based Bayesian Adaptive Randomised Controlled Trial in Pakistan | HSNIG | The Allergy and Asthma Institute, Pakistan | 25/10/2021 | 20211025 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104372 | Recruiting | No | 18 Years | N/A | All | May 1, 2021 | 405 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Care Provider, Investigator, Outcomes Assessor). | N/A | Pakistan | ; ; | Aziz Sheikh, MD, PhD;OSMAN M YUSUF, MBBS, PhD;Osman M Yusuf, MD, PhD | | ;allergypk@gmail.com;allergypk@gmail.com | ;+923008552557;+92512654445 | University of Edinburgh; |
<br> INCLUSION CRITERIA
<br>
<br> - Adults (=18 years)
<br>
<br> - Those living within larger cities of Pakistan (for laboratory access)
<br>
<br> - Those self-isolating at home within 5 days of the start of the illness with:
<br>
<br> 1. Clinical symptoms suggestive of COVID-19 (i.e. those who have at least one of the
<br> following symptoms: Respiratory symptoms, such as cough and shortness of breath;
<br> Fever; Muscle pain; Headache; Sore throat; New loss of taste or smell; Severe
<br> fatigue; Nausea or vomiting; Diarrhoea and Congestion or runny nose OR
<br>
<br> 2. Those with virologically confirmed SARS-CoV-2 infection and clinical symptoms
<br> indicative of COVID-19 (as detailed in (a) above).
<br>
<br> - Provision of informed consent
<br>
<br> EXCLUSION CRITERIA
<br>
<br> - Onset of illness (symptoms) more than 5 days
<br>
<br> - Inability to consent
<br>
<br> - Age less than 18 years.
<br>
<br> - Pregnancy
<br>
<br> - Immunosuppressed patients Inability to perform HSNIG
<br>
<br> - Those taking part in another interventional medical trial
<br>
<br> - Those with suspected/confirmed COVID-19 in whom hospital admission is recommended
<br>
<br> - Those who do not have access to email / internet
<br>
<br> - Those living in a household with another person currently participating in this study
<br>
<br> - Those who have not provided consent to take part
<br> | | COVID-19 | Other: Hypertonic Saline Nasal Irrigation and Gargles (HSNIG) | Time to resolution of symptoms | | | | Yes | False | | |
| +++ | NCT05104385 | 15 November 2021 | Hacettepe University COVID-19 Vaccinated's Health Cohort- Students of Health Sciences | Hacettepe Health Cohort: A Prospective Follow-up of the General Health Status and Effectiveness, Durability and Adverse Effects of COVID-19 Vaccine Among Students of Medical and Dental Schools | HU-CoVaCS | Hacettepe University | 31/10/2021 | 20211031 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104385 | Recruiting | No | 20 Years | 36 Years | All | June 21, 2021 | 1500 | Observational | | | Turkey | | Banu Cakir | | | | Hacettepe University, Division of Epidemiology (Chair) |
<br> Inclusion Criteria:
<br>
<br> 1) students of the medical school (grades 4,5 and 6) in 2021 Spring semester 2 )students of
<br> the dental school (grades 4 and 5) in 2021 Spring semester 3) new comers of grade 4 of
<br> medical and dental school in 2021 Fall semester 4) those providing informed consent to
<br> participate in the study.
<br>
<br> Exclusion Criteria:
<br>
<br> None.
<br> | | COVID-19 Pandemic;SARS-CoV2 Infection;Immunization; Infection;Health | Other: Observational, prospective, follow-up of the recipients of CoronaVac (inactivated), Pfizer-Biontech (mRNA) vaccines | Vaccine-induced immunity (status and durability) against SARS-CoV-2;General health status (physical, mental, social) | | | | Yes | False | | |
| +++ | NCT05104411 | 15 November 2021 | Rehabilitation in Severely Ill Inpatients With COVID-19: A Retrospective Cohort Study | Early Rehabilitation in Severely Ill Inpatients With COVID-19: A Retrospective Cohort Study With Short-term Follow-up | | Seoul National University Bundang Hospital | 22/10/2021 | 20211022 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104411 | Recruiting | No | N/A | N/A | All | August 14, 2021 | 37 | Observational | | | Korea, Republic of | ; ; | Jaewon Beom, MD, PhD;Hyeonseong Woo, MD;Jaewon Beom | | ;woohs20@gmail.com;powe5@snubh.org | ;+82-031-787-7739;+82-031-787-7739 | Department of Rehabilitation Medicine, Seoul National University Bundang Hospital; |
<br> Inclusion Criteria:
<br>
<br> COVID-19 patients who
<br>
<br> 1. underwent intensive care at least two days,
<br>
<br> 2. eventually got negative conversion with two consecutive tests,
<br>
<br> 3. were classified as severe COVID-19 (WHO ordinal scale 5-7) and
<br>
<br> 4. participated in the inpatient rehabilitation program were included.
<br>
<br> Exclusion Criteria:
<br>
<br> COVID-19 patients who died (WHO ordinal scale 8) before discharge were excluded
<br> | | COVID-19 | Other: Rehabilitative intervention | Change of Functional Ambulation Classification | | | | Yes | False | | |
| +++ | NCT05104749 | 15 November 2021 | Homeopathic Treatment of Post-acute COVID-19 Syndrome | Homeopathic Treatment of Post-acute COVID-19 Syndrome- A Pilot Randomized Controlled Trial | | Southwest College of Naturopathic Medicine | 28/10/2021 | 20211028 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104749 | Recruiting | No | 18 Years | 64 Years | All | September 15, 2021 | 62 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | United States | ; ; | Elizabeth Rice, ND;Elizabeth Rice, ND;Elizabeth Rice, ND | | ;e.rice@scnm.edu; | ;480-276-3808; | Southwest College of Naturopathic Medicine; |
<br> Inclusion Criteria:
<br>
<br> - Ages 18-64
<br>
<br> - Any ethnicity
<br>
<br> - Adequate cognitive function to be able to give informed consent
<br>
<br> - Technologically competent to complete web forms and perform video calls
<br>
<br> - Positive PCR test (polymerase chain reaction) result for SARS-CoV-2 (severe acute
<br> respiratory syndrome coronavirus 2)
<br>
<br> - Persistent fatigue for a minimum of 60 days since diagnosis of Covid-19.
<br>
<br> - A fatigue score above 21 in the Fatigue Assessment Scale upon enrollment
<br>
<br> - Full Covid-19 vaccination; i.e. 2 weeks after a two-dose series (Pfizer or Moderna) or
<br> 2 weeks after a single-dose vaccine (Johnson & Johnson)
<br>
<br> - Willing to fill out regular questionnaires
<br>
<br> - Willing to use homeopathic medicines
<br>
<br> Exclusion Criteria:
<br>
<br> - Clinically significant kidney, heart, or hepatic impairment as determined by clinical
<br> judgment
<br>
<br> - Previous hospitalization in ICU for Covid-19
<br>
<br> - Partial Covid vaccination or unvaccinated for Covid-19
<br>
<br> - Diagnosis of Chronic Fatigue Syndrome, Fibromyalgia, or Lyme disease prior to
<br> Covid-19
<br>
<br> - Chronic psychiatric illness or neurological illness prior to Covid-19 diagnosis
<br> Taking opioid analgesics, opioid dependence or undergoing treatment for substance
<br> abuse or addiction
<br>
<br> - Taking steroid medication or immunosuppressive medications
<br>
<br> - Suspected or confirmed pregnancy or breastfeeding
<br>
<br> - Active cancers
<br>
<br> - Current treatment by a homeopathic practitioner
<br>
<br> - Initiation of another treatment for Long Covid within the past 2 months
<br> | | Post-acute Covid-19 Syndrome | Drug: Homeopathic Medication;Other: Placebo | Fatigue Assessment Scale (FAS);Change in Fatigue Assessment Scale (FAS);36 Item Short Form Survey (SF 36);Change in 36 Item Short Form Survey (SF 36) | | | | Yes | False | | |
| +++ | NCT05104827 | 15 November 2021 | Integrative Medicine Impact on Frontline COVID-19 Personnel Wellbeing | Eran Ben-Arye is the Study Primary Investigator | | Carmel Medical Center | 01/11/2021 | 20211101 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104827 | Recruiting | No | 18 Years | N/A | All | December 31, 2020 | 300 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | Israel | ; ; | Eran Ben-Arye, MD;Eran Ben-Arye, MD;Eran Ben-Arye, MD | | ;eranben@netvision.net.il;eranbe@clalit.org.il | ;972528709282;972528709282 | Medical director, Integrative Oncology Program; |
<br> Inclusion Criteria:
<br>
<br> * Healthcare providers and personnel working in frontline COVID-19 hospital departments.
<br>
<br> Exclusion Criteria:
<br>
<br> * Personnel not consenting to participate
<br> | | Wellbeing of Healthcare Providersin Frontline COVID-19 Departments | Other: Complementary Integrative Medicine | Heart Rate Variability analysis;Qualitative quality of life assessment;Quantitative quality of life assessment | | | | No | False | | |
| +++ | NCT05104840 | 15 November 2021 | A Randomized Study to Determine the Expression of the Furin Protein in Patients With SARS-CoV-2 and Vaccinated Against Coronavirus | Randomized Study on Determine the Expression of the Furin Protein in Patients With Confirmed COVID-19 Disease (in Various Phases of the Disease), Recovered From SARS-CoV-2 and Vaccinated Against Coronavirus (All Types of Vaccines) | | Center Trials & Treatment | 28/10/2021 | 20211028 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05104840 | Not recruiting | No | 18 Years | N/A | All | December 1, 2021 | 3000 | Observational [Patient Registry] | | | United States;India;Ukraine;India;Ukraine;United States | ; | Central Contact;central contact | | ctt@mail.uk;ctt@mail.uk | +380997805042; | |
<br> Inclusion Criteria:
<br>
<br> - Any gender
<br>
<br> - Age > 18
<br>
<br> - Hospitalized adult male and female patients with Laboratory-confirmed novel
<br> coronavirus (SARS-CoV-2) infection
<br>
<br> - Laboratory-confirmed novel coronavirus (SARS-CoV-2) infection
<br>
<br> - All Confirmed COVID-19 Patients by PCR or highly suspected patients admitted to the
<br> chest department's isolation unit during the duration of the study
<br>
<br> - Able to understand and provide voluntary informed consent. Informed consent for
<br> participation in the study (consent can be oral if written consent cannot be expressed
<br>
<br> - Vaccination with any type of SARS-CoV-2 vaccine
<br>
<br> Exclusion Criteria:
<br>
<br> - Other medical condition other than COVID-19 or laboratory abnormality that may
<br> increase the risk of study participation or, in the investigator's judgment, make the
<br> participant inappropriate for the study
<br>
<br> - Suspected or known active systemic bacterial, viral (except SARS-CoV2 infection) or
<br> fungal infections
<br>
<br> - Active herpes zoster infection
<br>
<br> - Any physical examination findings and/or history of any illness that, in the opinion
<br> of the investigator, might confound the results of the study or pose an additional
<br> risk to the patient by their participation in the study
<br>
<br> - Participation in other clinical trials of investigational treatments for COVID-19.
<br> | | COVID-19;SARS-CoV-2;Furin;RGMc Processing;Paired Basic Amino Acid Cleaving Enzyme (PACE) | | Determination of the level of Furin protein in the blood of patients with confirmed SARS-CoV2 and being treated in a hospital;Determination of the level of Furin protein in the blood of patients with confirmed SARS-CoV2 and who are on outpatient treatment;Determination of the level of furin protein in the blood of those vaccinated against SARS-CoV2 after the first and second vaccinations (or after the ones-dose vaccine J&J) | | | | Yes | False | | |
| +++ | NCT05107245 | 15 November 2021 | Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of Patients With COVID-19. | Observational Study on the Diagnostic Evaluation of the Intestinal Microbiota of French People Infected With the SARS-CoV-2. | EDIFICE | Luxia Scientific | 22/10/2021 | 20211022 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05107245 | Not recruiting | No | 18 Years | 95 Years | All | April 28, 2020 | 143 | Observational | | | France | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - COVID-19 positive patients: hospitalised patients diagnosed with COVID-19 in one of
<br> the investigating sites, and able to provide a stool sample.
<br>
<br> - Control subjects: Medical and paramedical personnel working at one of the
<br> investigating sites, having been in direct contact with the patients.
<br>
<br> - Aged between 18 and 95 years.
<br>
<br> - Subjects able to read the French-language study information leaflet.
<br>
<br> - Patients with social cover.
<br>
<br> Exclusion Criteria:
<br>
<br> - COVID-19 negative patients.
<br>
<br> - Patients in resuscitation, heart failure or respiratory failure.
<br>
<br> - Unable to provide naturally a stool sample.
<br>
<br> - Patients without social cover.
<br>
<br> - Pregnant women
<br> | | COVID-19 | Diagnostic Test: 1test1 | Alpha-diversity | | | | No | False | | |
| +++ | NCT05107258 | 15 November 2021 | A Clinical Evaluation of Pine Trees Health Test System Including the Pine Trees Health Reader and COVID-19 Test for Point-of-Care | A Clinical Evaluation of Pine Trees Health Test System Including the Pine Trees Health Reader and COVID-19 Test for Point-of-Care | | Pine Trees, Inc. | 02/11/2021 | 20211102 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05107258 | Not recruiting | No | 6 Years | N/A | All | August 17, 2021 | 195 | Observational | | | United States | | Patrice Milos, PhD | | | | Pine Trees Health |
<br> Inclusion Criteria:
<br>
<br> 1. Subjects must present with 1 or more signs or symptoms of COVID-19 infection*.
<br>
<br> 2. Subjects must have experienced symptom onset within the previous 10 days.
<br>
<br> 3. Subject or Subject's legally authorized representative (LAR) is willing and able to
<br> provide informed consent. Adult subjects unable to consent will provide assent in
<br> addition to LAR's consent.
<br>
<br> 4. Subject is = 6 years of age. Subjects 6 = x = 17 will provide assent in addition to
<br> parent/legal guardian's consent.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Individual is not able to tolerate sample collection.
<br>
<br> 2. The subject has been positive for SARS-CoV-2 previously.
<br>
<br> 3. The subject underwent a nasal wash/aspirate as part of standard of care <24 hours
<br> prior to the study visit.
<br>
<br> 4. The subject is currently receiving or has received within the past thirty (30) days of
<br> the study visit an experimental biologic, drug, or device including either treatment
<br> or therapy.
<br>
<br> 5. The subject has previously participated in this research study.
<br>
<br> - Symptoms may appear 2-10 days after exposure and may include one or more of the
<br> following: Fever, Cough, Shortness of Breath, Difficulty Breathing, Muscle Pain,
<br> Headache, Sore Throat, Chills, New Loss of Taste or Smell, Congestion, Runny
<br> Nose, Diarrhea, Nausea or vomiting.
<br> | | SARS (Severe Acute Respiratory Syndrome);Covid19 | Diagnostic Test: The Pine Trees Health Test System | Primary Outcome | | | | Yes | False | | |
| +++ | NCT05107271 | 15 November 2021 | Evaluation of Long Haul COVID-19 and Vaccine Immunogenicity in Patients With Liver Disease | Comprehensive Assessment of Intermediate and Long-term Sequelae of COVID-19 Infection and Immunological Correlates of Protection Induced by COVID-19 Vaccines in Patients With Liver Disease: A Prospective Cohort Study. | EvaLongCovid | Postgraduate Institute of Medical Education and Research | 03/11/2021 | 20211103 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05107271 | Not recruiting | No | 18 Years | 75 Years | All | November 15, 2021 | 300 | Observational | | | India | ; | Virendra Singh, MD DM;Madhumita Premkumar, MD DM | | ;drmadhumitap@gmail.com | ;+919540951061 | Postgraduate Institute of Medical Education and Research; |
<br> Inclusion Criteria:
<br>
<br> 1. The person is between the ages of 18-75 years at the time of signing the informed
<br> consent form.
<br>
<br> 2. Individual has chronic liver disease of any etiology and is attached to the Hepatology
<br> services of the PGIMER, Chandigarh.
<br>
<br> 3. Individual has had a positive SARS-COV-02 test (PCR) within the last 12 months or has
<br> been diagnosed presumptive positive and has been treated for COVID-19 within the last
<br> 12 months.
<br>
<br> 4. Individual has not fully recovered from COVID-19 in weeks or months despite a negative
<br> Sars-COV-02 test and has been diagnosed with Post COVID-19 syndrome.
<br>
<br> 5. Individual is experiencing 2 or more symptoms for over 12 weeks either continually or
<br> intermittently with relapses not experienced pre-illness, that interferes with normal
<br> daily activities. Symptoms must be new symptoms, or dramatic worsening of symptoms
<br> i.e., subject did not have symptoms, and had not sought medical treatment for the
<br> symptoms prior to COVID-19, or the symptoms are dramatically worse (in severity and
<br> frequency).
<br>
<br> - Extreme fatigue - feeling overtired with low energy and a strong desire to sleep.
<br>
<br> - Shortness of breath - (dyspnea) a feeling of being winded, difficulty in
<br> breathing, or a hunger for air.
<br>
<br> - Cough - hacking, or dry barking sound lingering dry or wet.
<br>
<br> - Brain fog -a diminished mental capacity marked by the inability to concentrate or
<br> to think or reason clearly that interferes with daily activities.
<br>
<br> - Headache - Sharp or dull reoccurring or intermittent that were not present
<br> pre-illness.
<br>
<br> - Body aches - muscle soreness or generalized achiness throughout the body.
<br>
<br> - Joint pain - pain in the joints due to inflammation not experienced before
<br> illness.
<br>
<br> - Chest pain - (angina) feeling pressure, fullness, or tightness in your chest
<br>
<br> - Sleep issues - any sleep disturbances in sleep quality that makes sleep see
<br> inadequate or unrefreshing like insomnia or hypersomnia.
<br>
<br> - Loss of Taste/Smell - Diminished sense of taste or smell.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Subject is unable to provide informed consent or to comply with study requirements.
<br>
<br> 2. Subject has currently been diagnosed with active COVID-19 disease.
<br> | | COVID-19;Chronic Liver Failure;Cirrhosis, Liver;Portal Hypertension;Liver Transplant Disorder | Diagnostic Test: COVID-19 serosurvey | Long haul COVID-19 related symptoms;Immunogenicity of vaccine | | | | Yes | False | | |
| +++ | NCT05107375 | 15 November 2021 | Clinical Study of Recombinant Novel Coronavirus(COVID-19) Vaccine (CHO Cell) Combined With Influenza Vaccine | Clinical Study on Immunogenicity and Safety of Recombinant Novel Coronavirus(COVID-19)Vaccine (CHO Cell) Combined With Tetravalent Influenza Virus Lysis Vaccine in People Aged 18 Years and Over | | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. | 01/11/2021 | 20211101 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05107375 | Recruiting | No | 18 Years | N/A | All | September 3, 2021 | 300 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 3 | China | ; ; | Tao Huang;Tao Huang;Tao Huang | | ;ymlc01@hncdc.com;ymlc01@hncdc.com | ;15084736658;15084736658 | Hunan Center for Disease Control and Prevention; |
<br> Inclusion Criteria:
<br>
<br> 1. Healthy subjects aged 18 and above with full capacity for civil conduct, who can
<br> provide valid identification;
<br>
<br> 2. The subjects voluntarily agree to participate in the study and sign the informed
<br> consent to understand and comply with the requirements of the study protocol;
<br>
<br> 3. Fertile men and women of reproductive age did not have sex from day 1 of the last
<br> menstrual cycle to day 1 of the study, or did not have sex using effective
<br> contraceptive methods and did not experience contraceptive failure (examples of
<br> contraceptive failure include male condom rupture during sex). At the same time,
<br> subjects agreed to take effective contraceptive measures for 1 month from the signing
<br> of informed consent to the full immunization and no pregnancy plans during this
<br> period.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. History of novel coronavirus infection confirmed or asymptomatic infected persons or
<br> positive nucleic acid test of novel Coronavirus;
<br>
<br> 2. SARS virus history;
<br>
<br> 3. For those with fever, axillary temperature =37.3? on the day of inclusion;
<br>
<br> 4. A past history of severe allergy to any vaccine, or to the active ingredient of the
<br> test vaccine, any inactive ingredient, or substance used in the manufacturing process,
<br> including aluminum preparations, egg protein, neomycin, formaldehyde, tritonX-100,
<br> such as: Acute anaphylaxis, dyspnea, angioneurotic edema, etc., or allergies during
<br> previous vaccinations of the same kind;
<br>
<br> 5. Patients with uncontrolled epilepsy and other serious neurological diseases (e.g.,
<br> transverse myelitis, Guillain-Barre syndrome, demyelinating disease, etc.);
<br>
<br> 6. Patients with acute diseases, or acute episodes of chronic diseases, or uncontrolled
<br> severe chronic diseases (such as hypertension that cannot be controlled by drugs,
<br> systolic blood pressure =160mmHg and/or diastolic blood pressure =100mmHg);
<br>
<br> 7. Patients at the active stage of autoimmune diseases (systemic lupus erythematosus,
<br> rheumatoid arthritis, ankylosing spondylitis, sjogren's syndrome, etc.), patients with
<br> congenital or acquired immune deficiency, HIV infection with opportunistic infection
<br> or uncontrolled malignant tumor, lymphoma and leukemia;
<br>
<br> 8. No spleen, or splenic operation history;
<br>
<br> 9. Received immunomodulators within 6 months, such as immunosuppressive doses of
<br> glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week); Or
<br> monoclonal antibodies; Or thymosin; Or interferon; However, topical use (such as
<br> ointments, eye drops, inhalants or nasal sprays) is allowed;
<br>
<br> 10. Has received blood or blood-related products, including immunoglobulin (including
<br> rabies immunoglobulin and tetanus immunoglobulin), within 3 months prior to
<br> experimental vaccine vaccination; Or planned use of the experimental vaccine within 1
<br> month of vaccination;
<br>
<br> 11. If subunit vaccine and inactivated vaccine are administered within 7 days prior to
<br> experimental vaccine inoculation, live attenuated vaccine shall be administered within
<br> 14 days prior to experimental vaccine inoculation;
<br>
<br> 12. Lactating women or pregnant women (including women of childbearing age with positive
<br> urine pregnancy test);
<br>
<br> 13. Those who have participated in or are participating in clinical trials related to
<br> COVID-19, or are participating in clinical trials of other drugs, or have received
<br> COVID-19 vaccines; The Investigator believes that the subject has any disease or
<br> condition that may place the subject at unacceptable risk; Subjects cannot meet the
<br> requirements of the program; Conditions that interfere with the assessment of vaccine
<br> response.
<br> | | Coronavirus Disease 2019 | Biological: Tetravalent influenza virus lysis vaccine;Biological: Recombinant new coronavirus vaccine (CHO cell) group | Primary endpoint: | | | | Yes | False | | |
| +++ | NCT05107440 | 15 November 2021 | BREATHE: Virtual Self-management for Long COVID-19 | BREATHE: A Mixed-methods Evaluation of a Virtual Self-management Program for People Living With Long COVID-19 in Alberta | | University of Calgary | 13/10/2021 | 20211013 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05107440 | Not recruiting | No | 18 Years | N/A | All | October 25, 2021 | 36 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Supportive Care. Masking: None (Open Label). | N/A | | ; | Nicole Culos-Reed, PhD;Rosie Twomey, PhD | | ;rosemary.twomey@ucalgary.ca | ;403) 220-5110 | University of Calgary; |
<br> Eligibility criteria were based on the World Health Organization's clinical case definition
<br> for post-COVID-19 condition, which "occurs in individuals with a history of probable or
<br> confirmed Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, usually 3
<br> months from the onset of COVID-19 with symptoms that last for at least 2 months and cannot
<br> be explained by an alternative diagnosis. Common symptoms include fatigue, shortness of
<br> breath, cognitive dysfunction but also others which generally have an impact on everyday
<br> functioning. Symptoms may be new onset, following initial recovery from an acute COVID-19
<br> episode, or persist from the initial illness. Symptoms may also fluctuate or relapse over
<br> time".
<br>
<br> Inclusion Criteria:
<br>
<br> - Participant has English language fluency (approximately grade 8-10 reading level) and
<br> is able to provide informed consent.
<br>
<br> - Participant is a resident in Alberta, Canada.
<br>
<br> - Participant had confirmed COVID-19 via a positive molecular or antigen test within the
<br> past 18 months. Alternatively, in the case of a lack of access to testing, evidence of
<br> infection including close contact with a confirmed case of COVID-19 or being linked
<br> with a COVID-19 outbreak, or an acute illness including the core symptoms of COVID-19
<br> (cough, fever, shortness of breath, runny nose, sore throat, loss of taste or smell).
<br>
<br> - Experiencing symptoms and ongoing functional limitations that have persisted for =3
<br> months (from the first positive test/known exposure date/symptom onset). At least one
<br> self-reported symptom is fatigue, shortness of breath, cognitive dysfunction or
<br> activity intolerance, and
<br>
<br> - Post-COVID-19 Functional Status Scale (PFSS) score of =2 [22,23].
<br>
<br> - Symptoms developed or substantially worsened during or after the acute infection
<br> (i.e., they are not explained by a co-occurring condition that pre-dates COVID-19).
<br>
<br> Exclusion Criteria:
<br>
<br> - Participant does not have access to a smart phone or computer (desktop, laptop, or
<br> tablet).
<br>
<br> - Receiving ongoing physical therapy via the Workers' Compensation Board.
<br>
<br> - Participants are currently participating in a regular rehabilitation program such as
<br> the Alberta Health Services (AHS) "Breathe Easy Program - Pulmonary Rehabilitation" or
<br> "Supervised Transitional Exercise Program (STEP) Forward - program." Previous
<br> participation or being on the waitlist for these services are not exclusion criteria.
<br>
<br> - A peripheral oxygen saturation <92% at rest on room air, syncope at rest or on
<br> exertion, and any other significant medical complexity that might require medical
<br> attention based on clinical judgement.
<br>
<br> - A diagnosis of a post-viral syndrome including myalgic encephalomyelitis/chronic
<br> fatigue syndrome (ME/CFS) that pre-dates COVID-19.
<br> | | COVID-19 | Other: BREATHE | Self-efficacy to manage symptoms;Self-efficacy to manage daily activities;Self-efficacy to manage emotions | | | | Yes | False | | |
| +++ | NCT05107479 | 15 November 2021 | Effectiveness of Interactive Voice Response for COVID-19 Vaccination Training in the Democratic Republic of the Congo | Effectiveness of Interactive Voice Response (IVR) for COVID-19 Vaccination Training of Frontline Health Workers: Experimental Evidence From the Democratic Republic of the Congo | | Stanford University | 11/10/2021 | 20211011 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05107479 | Not recruiting | No | 18 Years | N/A | All | November 2021 | 8959 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). | N/A | | | Jamie Johnston, PhD | | jamiejs@stanford.edu | 1 (650) 724-8074 | |
<br> Inclusion Criteria:
<br>
<br> - Identified by the DRC Ministry of Health as priority health worker to receive the
<br> training
<br>
<br> Exclusion Criteria:
<br>
<br> - Not identified by the DRC Ministry of Health as priority health worker to receive the
<br> training
<br> | | COVID-19 Vaccine Knowledge;COVID-19 Vaccine Beliefs | Behavioral: COVID-19 Vaccine IVR Training;Behavioral: Control Condition | COVID-19 vaccine promotion;COVID-19 vaccination status;COVID-19 vaccine knowledge | | | | Yes | False | | |
| +++ | NCT05107557 | 15 November 2021 | Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell) | A Randomized and Controlled Phase IV Clinical Trial to Evaluate the Immunogenicity and Safety of COVID-19 Vaccine (Vero Cell), Inactivated Co-administrated With EV71 Vaccine (Vero Cell) in Children Aged 3-5 Years Old | | Sinovac Biotech Co., Ltd | 02/11/2021 | 20211102 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05107557 | Not recruiting | No | 3 Years | 5 Years | All | November 5, 2021 | 520 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 4 | China | ; | Zhuhang Huang, Master;Zhuhang Huang, Master | | ;gdswyw_sps@cdcp.org.cn | ;13602438596 | Guangdong Center for Disease Prevention and Control; |
<br> Inclusion Criteria:
<br>
<br> - Children aged 3-5 years;
<br>
<br> - The subject and/or guardian can understand and voluntarily sign the informed consent
<br> form;
<br>
<br> - Proven legal identity.
<br>
<br> Exclusion Criteria:
<br>
<br> - History of contact with a SARS-CoV-2 infection (positive in nucleic acid test) within
<br> 14 days;
<br>
<br> - History of multiple system inflammatory syndrome (MIS-C);
<br>
<br> - History of hand, foot and mouth disease, herpetic angina or EV71 vaccination;
<br>
<br> - History of asthma, history of allergy to the vaccine or vaccine components,or serious
<br> adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema;
<br>
<br> - Congenital malformations or developmental disorders, genetic defects,severe
<br> malnutrition, etc.;
<br>
<br> - Autoimmune disease (Systemic lupus erythematosus)or immunodeficiency /
<br> immunosuppression(HIV,history after organ transplantation);
<br>
<br> - Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes
<br> that cannot be controlled by drugs, liver or kidney diseases,malignant tumors, etc.;
<br>
<br> - Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
<br>
<br> - Thyroid disease or history of thyroidectomy, asplenia,functional asplenia, asplenia or
<br> splenectomy resulting from any condition;
<br>
<br> - Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors,
<br> blood coagulopathy,abnormal platelets) or obvious bruising or blood coagulation;
<br>
<br> - Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding
<br> allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis
<br> superficial corticosteroid therapy) in the past 6 months;
<br>
<br> - History of drug abuse;
<br>
<br> - Receipt of blood products within in the past 3 months;
<br>
<br> - Receipt of other investigational drugs in the past 30 days;
<br>
<br> - Receipt of attenuated live vaccines in the past 14 days;
<br>
<br> - Receipt of inactivated or subunit vaccines in the past 7 days;
<br>
<br> - Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
<br>
<br> - Axillary temperature >37.0°C;
<br>
<br> - The subjects participated in other clinical trials during the follow-up period,or will
<br> be planned within 3 months;
<br>
<br> - According to the investigator's judgment, the subject has any other factors that are
<br> not suitable for participating in the clinical trial.
<br> | | COVID-19 | Biological: Experimental Group | Immunogenicity index-Seroconversion rate of the neutralizing antibody to live SARS-CoV-2;Immunogenicity index-Seroconversion rate of the neutralizing antibody to EV71 | | | | Yes | False | | |
| +++ | NCT05108584 | 15 November 2021 | Intubation in Coronavirus Disease 19 With Level 3 PPE | The Intubation Procedure in COVID-19 Pandemic | | Indonesia University | 18/10/2021 | 20211018 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05108584 | Not recruiting | No | 18 Years | 59 Years | All | November 4, 2021 | 39 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Indonesia | ; ; | Dita Aditianingsih;Dita Aditianingsih;Dita Aditianingsih | | ;ditaaditia@gmail.com;ditaaditia@gmail.com | ;+6281316114154;+6281316114154 | Indonesia University; |
<br> Inclusion Criteria:
<br>
<br> - Age 18 to 59 years old
<br>
<br> - Undergo elective or emergency surgery using general anesthesia with endotracheal tube
<br>
<br> - BMI below 30 kg/m2
<br>
<br> Exclusion Criteria:
<br>
<br> - Airway difficulty as assessed by preoperative assessment
<br>
<br> - Critical patients with unstable hemodynamics
<br>
<br> - Suspected or confirmed COVID-19 with ASA 3-5
<br> | | Intubation Complication | Procedure: PPE Level 3 and Video Laryngoscope;Procedure: PPE Level 3 and Direct Laryngoscope;Procedure: PPE Level 2 and Direct Laryngoscope | Safety as assessed by number of participants experiencing complications;Success of intubation process as assessed by number of trials;Total duration of the intubation process | | | | Yes | False | | |
| +++ | NCT05109546 | 15 November 2021 | Geriatric COVID Serology | Geriatric COVID Serology | SeroGerCov | University Hospital, Strasbourg, France | 04/11/2021 | 20211104 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05109546 | Recruiting | No | 76 Years | N/A | All | October 15, 2021 | 200 | Observational | | | France | ; ; | Maxence MEYER, MD;Maxence MEYER, MD;Maxence MEYER, MD | | ;maxence.meyer@chru-strasbourg.fr;maxence.meyer@chru-strasbourg.fr | ;33 3 88 11 56 16;33 3 88 11 56 16 | Service SSR Gériatrique - Hôpitaux Universitaires de Strasbourg; |
<br> Inclusion criteria:
<br>
<br> - Age> 75 years old
<br>
<br> - Patient hospitalized or resident in the geriatrics center from July 1, 2020 to
<br> November 30, 2021 having presented with COVID or having benefited from a COVID
<br> vaccination.
<br>
<br> - Subject not having expressed their opposition, after information, to the reuse of
<br> their data for the purposes of this research
<br>
<br> Exclusion criteria:
<br>
<br> - Subject having expressed opposition to participating in the study
<br>
<br> - Impossibility of providing the subject with enlightened information (difficulties in
<br> understanding the subject, etc.)
<br>
<br> - Subject under guardianship, curatorship or safeguard of justice
<br> | | COVID-19 | | Retrospective study of COVID serologies in a geriatric population after infection or vaccination | | | | Yes | False | | |
| +++ | NCT05109559 | 15 November 2021 | Ad26.COV2.S as a Heterologous Booster in Adults After Single- or Two-Dose of Inactivated COVID-19 Vaccine | A Phase 1/2 Study to Evaluate the Safety Reactogenicity and Immunogenicity of Ad26.COV2.S Administered as a Heterologous Booster Vaccination in Adults 18 Years of Age and Older Following Single- or Two-Dose Vaccination With an Inactivated COVID-19 Vaccine | | Mahidol University | 03/11/2021 | 20211103 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05109559 | Not recruiting | No | 18 Years | N/A | All | December 2021 | 690 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Triple (Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | | ; | Punnee Pitisuttithum, MD;Sant Muangnoicharoen, MD | | ;sant.mua@mahidol.ac.th | ;+66851998989 | Mahidol University; |
<br> Inclusion Criteria:
<br>
<br> Potential participants must meet all inclusion criteria to be enrolled and participate in
<br> the study, as follows:
<br>
<br> 1. Adult male or female aged 18 years or more on the day of signing the ICF, confirmed by
<br> identification cards.
<br>
<br> 2. Verified, documentation of past COVID-19 vaccination i. Study Part A: having completed
<br> the 2-dose homologous primary regimen (21 to 28 days apart) of inactivated COVID-19
<br> vaccine of either Sinovac-Sinovac OR Sinopharm-Sinopharm ii. Study Part B: having
<br> received one dose of inactivated COVID-19 vaccine of either Sinovac or Sinopharm with
<br> the appropriate interval period
<br>
<br> 3. Subject has provided written informed consent prior to performance of any
<br> study-specific procedures and is willing and has means to be contacted and to contact
<br> the investigator during the study.
<br>
<br> 4. In the investigator's clinical judgment, the participant is in good health, or has
<br> stable and well-controlled medical conditions.
<br>
<br> 5. Participant agrees to not donate bone marrow, blood, and blood products from the study
<br> vaccine administration until 3 months after receiving the study vaccine.
<br>
<br> Exclusion Criteria:
<br>
<br> Potential participants who meet any of the following exclusion criteria will be excluded
<br> from enrolment and participation in the study:
<br>
<br> 1. The participant has a clinically significant acute illness (this does not include
<br> minor illnesses such as diarrhea or mild upper respiratory tract infection), or is a
<br> patient under investigation (PUI) or has a body temperature =38.0ºC (100.4°F) within
<br> 24 hours prior to the planned study vaccination. Assignment may be made at a later
<br> date is permitted at the discretion of the investigator. Please notify the Sponsor (or
<br> medical monitor) of this decision.
<br>
<br> 2. Contraindication to Ad26.COV2.S according to labelling of the product. For example, if
<br> the participant has a known or suspected allergy or history of anaphylaxis or other
<br> serious adverse reactions to vaccines or their excipients (including specifically the
<br> excipients of the study vaccine; refer to the IB (IB Edition 5 Ad26.COV2.S 2021 and
<br> its addenda).
<br>
<br> 3. Participant has a history or current condition as follows
<br>
<br> 1. Known documented history of COVID-19 infection prior to enrollment
<br>
<br> 2. Any confirmed or suspected immunosuppressive or immunodeficient state.
<br>
<br> 3. Heparin-induced thrombocytopenia or thrombosis in combination with
<br> thrombocytopenia.
<br>
<br> 4. Acute polyneuropathy (e.g. Guillain-Barré syndrome).
<br>
<br> 5. Capillary leak syndrome
<br>
<br> 6. Contraindication to IM injections and blood draws e.g., bleeding disorders.
<br>
<br> 7. An underlying clinically significant acute or chronic medical condition or
<br> physical examination findings for which, in the opinion of the investigator,
<br> participation would not be in the best interest of the participant (e.g.,
<br> compromise the well being) or that could prevent, limit, or confound the
<br> protocol-specified assessments.
<br>
<br> 8. Major psychiatric illness which in the investigator's opinion would compromise
<br> the participant's safety or compliance with the study procedures.
<br>
<br> 4. If the participant received or plans to receive:
<br>
<br> 1. Licensed live attenuated vaccines - within 28 days before or after planned
<br> administration of study vaccine.
<br>
<br> 2. Other licensed (not live) vaccines - within 14 days before or after planned
<br> administration of study vaccine.
<br>
<br> 3. Treatment with immunoglobulins (Ig) in the 3 months or exogenous blood products
<br> (autologous blood transfusions are not exclusionary) in the 4 months before the
<br> planned administration of the study vaccine or has any plans to receive such
<br> treatment during the study.
<br>
<br> 5. If the participant cannot communicate reliably with the investigator, or, in the
<br> opinion of the investigator, is unlikely to adhere to the requirements of the study or
<br> is unlikely to complete the full course of vaccination and observation.
<br>
<br> 6. Employee of the study center directly involved with the proposed study or with study
<br> investigators.
<br> | | SARS-CoV-2 Infection | Biological: Full dose of Ad26.COV2.;Biological: Half dose of Ad26.COV2. | Frequency of solicited reportable local adverse event after vaccination;Frequency of solicited reportable systemic adverse event after vaccination;Frequency of all unsolicited AEs;GMT Anti-S IgG at baseline;GMT Anti-S IgG at 7 days after vaccination in subset subjects;GMT Anti-S IgG at 14 days after vaccination in subject subjects;GMT Anti-S IgG at 28 days after vaccination;GMT Anti-S IgG at 84 days after vaccination;GMT Anti-S IgG at 168 days after vaccination;GMT Anti-S IgG at 336 days after vaccination;GMFR changed from baseline in anti-S IgG GMT at 28 days after vaccination;GMFR changed from baseline in anti-S IgG GMT at 84 days after vaccination;GMFR changed from baseline in anti-S IgG GMT at 168 days after vaccination;GMFR changed from baseline in anti-S IgG GMT at 336 days after vaccination;Anti-S IgG Seroresponses changed from baseline at 28 days after vaccination;Anti-S IgG Seroresponses changed from baseline at 84 days after vaccination;Anti-S IgG Seroresponses changed from baseline at 168 days after vaccination;Anti-S IgG Seroresponses changed from baseline at 336 days after vaccination | | | | Yes | False | | |
| +++ | NCT05109572 | 15 November 2021 | The Impact of the Covid-19 Pandemic on Schizophrenia Patients Registered With the Community Mental Health Center | The Impact of the Covid-19 Pandemic on Schizophrenia Patients Registered With the Community Mental Health Center | | Dr. Lutfi Kirdar Kartal Training and Research Hospital | 26/10/2021 | 20211026 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05109572 | Not recruiting | No | 18 Years | 65 Years | All | March 20, 2021 | 108 | Observational | | | Turkey | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - between the ages of 18-65,
<br>
<br> - receiving service from Kartal Dr. Lütfi Kirdar City Hospital Adatepe CMHC,
<br>
<br> - having been diagnosed with schizophrenia for at least two years,
<br>
<br> - not being in the active phase of the disease,
<br>
<br> - not having an organic mental disorder,
<br>
<br> - not having an additional psychiatric illness, and
<br>
<br> - being literate
<br>
<br> Exclusion Criteria:
<br>
<br> - Individuals with cognitive and physical dysfunction,
<br>
<br> - mental retardation, different psychiatric diseases that would prevent interview or
<br> testing, and
<br>
<br> - those who did not consent to participate in the study
<br> | | Schizophrenia | Other: Hospitalized;Other: Non-hospitalized with emergency care;Other: Non-hospitalized and non-emergency care | Calgary Depression Scale in Schizophrenia;Buss-perry Aggression Questionnaire;Suicide Probability Scale | | | | Yes | False | | |
| +++ | NCT05109585 | 15 November 2021 | Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination Study | Determinants of the Level of Anti-SARS-CoV-2 IgG ANTibodiEs After Vaccination (DANTE-SIRIO 7) Study | DANTE-SIRIO 7 | Collegium Medicum w Bydgoszczy | 04/11/2021 | 20211104 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05109585 | Not recruiting | No | 18 Years | N/A | All | April 20, 2021 | 1000 | Observational | | | Poland | | Jacek Kubica, Prof. | | | | Collegium Medicum w Bydgoszczy |
<br> Inclusion Criteria:
<br>
<br> - Provision of informed consent to study
<br>
<br> - Age = 18 years
<br>
<br> - Receiving two doses of the BNT162b2 vaccine
<br>
<br> Exclusion Criteria:
<br>
<br> - patients who did not complete 2-dose vaccination schedule
<br>
<br> - patients who received any other vaccine than BNT162b2
<br>
<br> - patients considered by investigator to be unable to cooperate
<br> | | SARS-CoV2 Infection;SARS-CoV2 Antibodies | Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 3-dose schedule;Diagnostic Test: assessment of the anti-SARS-CoV-2 IgG antibody titer in 2-dose schedule | the anti-SARS-CoV-2 IgG antibody concentration 3 months after vaccination cycle with the BNT162b2 vaccine | | | | Yes | False | | |
| +++ | NCT05109598 | 15 November 2021 | Clinical Trial of Immunogenicity Bridging of a Recombinant New Coronavirus(COVID-19) Vaccine (CHO Cell) | A Clinical Trial Comparing the Immunogenicity of Recombinant New Coronavirus Vaccine (CHO Cells) Among People Aged 3 to 17 and 18 to 59 Years of Age. | | Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. | 04/11/2021 | 20211104 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05109598 | Recruiting | No | 3 Years | 17 Years | All | November 4, 2021 | 400 | Interventional | Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 2 | China | ; ; | Tao Huang;Fangjun Li;Fangjun Li | | ;646022285@qq.com;646022285@qq.com | ;13574109585;13574109585 | Hunan Center for Disease Control and Prevention; |
<br> Inclusion Criteria:
<br>
<br> 1. At least 3 ~ 17 years old (both included);
<br>
<br> 2. The subject voluntarily agrees to participate in the study, and / or the guardian of
<br> the subject voluntarily agrees to the child to participate in the study. The subject
<br> himself (8-17 years old) and the guardian sign the informed consent form, and can
<br> provide valid identity certificates to understand and comply with the requirements of
<br> the test protocol;
<br>
<br> 3. The subject and / or the guardian of the subject have the ability to understand (non
<br> illiterate) the research procedures and promise to participate in regular follow-up
<br> according to the research requirements;
<br>
<br> 4. There is no high or medium risk area, overseas travel history or residence history in
<br> the past 14 days; In the past 14 days, no confirmed case of New Coronavirus infection,
<br> asymptomatic infection or suspected cases had been found. And there was no contact
<br> history of patients with fever or respiratory symptoms from high and medium risk areas
<br> in the past 14 days; Personnel in non isolation period;
<br>
<br> 5. Male and female subjects with fertility agreed to take effective contraceptive
<br> measures from the beginning of the study to 2 months after the whole vaccination.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. The results of physical examination during screening period are abnormal and
<br> clinically significant (not suitable for vaccination) as determined by clinicians;
<br>
<br> 2. Suspected or confirmed fever within 72 hours before enrollment (including the day of
<br> enrollment) (> 14 years old, axillary temperature = 37.3 ?; = 14 years old, axillary
<br> temperature = 37.5 ?);
<br>
<br> 3. Have a history of severe allergy to any component of the test vaccine, including
<br> aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic
<br> purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, etc; Or have a
<br> history of the above serious side effects after the use of any vaccine or drug in the
<br> past;
<br>
<br> 4. had previous history of SARS and SARS-CoV-2.
<br>
<br> 5. Taking antipyretics or painkillers within 24 hours before the first dose of vaccine;
<br>
<br> 6. persons who have been vaccinated with New Coronavirus or inoculated with live
<br> attenuated vaccine within 7 days or within 7 days before the first dose of vaccine are
<br> inoculated with inward subunit vaccine and / or inactivated vaccine.
<br>
<br> 7. Have received blood or blood related products, including immunoglobulin, within 3
<br> months before the vaccination of the test vaccine; Or planned use during the study;
<br>
<br> 8. Persons suffering from the following diseases:
<br>
<br> ? Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the
<br> past 7 days;
<br>
<br> ? Suffering from congenital malformations or developmental disorders, genetic defects,
<br> severe malnutrition, etc;
<br>
<br> ? History of congenital or acquired immune deficiency or autoimmune diseases or
<br> receiving immunomodulator treatment within 6 months, such as immunosuppressive dose of
<br> Glucocorticoid (dose reference: equivalent to prednisone 20mg / day, more than one
<br> week); Or monoclonal antibody; Or thymosin; Or interferon, etc; However, topical
<br> medication (such as ointment, eye drops, inhalants or nasal sprays) is allowed;
<br>
<br> ? It is known that it is diagnosed with infectious diseases, such as active
<br> tuberculosis, viral hepatitis present, human immunodeficiency virus infection or
<br> Treponema pallidum infection.
<br>
<br> ? Neurological diseases or neurodysplasia (e.g., convulsions, migraines, epilepsy,
<br> stroke, seizures in the last three years, encephalopathy, focal neurological deficit,
<br> Guillain Barre syndrome, encephalomyelitis or transverse myelitis); History of
<br> psychosis or family history;
<br>
<br> ? Functional absence of spleen, and absence of spleen or splenectomy for any reason;
<br>
<br> ? There are serious chronic diseases or disease in progress can not be controlled
<br> smoothly, such as diabetes, drugs can not control hypertension.
<br>
<br> ? Severe liver and kidney diseases; Respiratory diseases that currently require daily
<br> drug treatment (e.g., chronic obstructive pulmonary disease [COPD], asthma) or any
<br> treatment for aggravation of respiratory diseases (e.g., aggravation of asthma) in the
<br> last 5 years; A history of serious cardiovascular disease (such as congestive heart
<br> failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block,
<br> myocardial infarction, cor pulmonale) or myocarditis or pericarditis;
<br>
<br> ? Thrombocytopenia, any coagulation dysfunction or anticoagulant treatment;
<br>
<br> ? Cancer patients (except basal cell carcinoma);
<br>
<br> 9. Lactating women or pregnant women (including women of childbearing age with positive
<br> urine pregnancy test), or women or their partners who have pregnancy plans within 2
<br> months after the whole vaccination of the test vaccine;
<br>
<br> 10. Those who have participated or are participating in other clinical trials, and the
<br> relevant visits have not been completed, or are clearly vaccinated after the
<br> completion of the new crown vaccine;
<br>
<br> 11. The researcher believes that the subject has any disease or condition that may put the
<br> subject at unacceptable risk; The subjects were unable to meet the protocol
<br> requirements; Interference with the evaluation of vaccine response.
<br> | | Coronavirus Disease 2019 | Biological: Recombinant new coronavirus vaccine (CHO cell) | Immunogenic end point;The number of adverse events after intramuscular injection;The number of serious adverse events after intramuscular injection | | | | Yes | False | | |
| +++ | NCT05109611 | 15 November 2021 | Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection | Decentralized, Randomized, Double-blinded, Placebo-controlled, Phase 3 Clinical Efficacy Study Evaluating Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection | | Sanotize Research and Development corp. | 03/11/2021 | 20211103 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05109611 | Not recruiting | No | 18 Years | N/A | All | December 20, 2021 | 13000 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 3 | | ; | Keith Moore, PHARMD;Gil Talmaciu, BSc | | ;gtalmaciu@sanotize.com | ;7788695590 | Sanotize Research and Development corp.; |
<br> Inclusion Criteria:
<br>
<br> Each participant must meet the following criteria to be enrolled in this study.
<br>
<br> 1. At least aged 18 years old at the time of consent.
<br>
<br> 2. If female, be surgically sterile or post-menopausal (no menses for at least 12
<br> months), or if of child-bearing potential, must be using an acceptable method of
<br> contraception (other than a combination estrogen/progestin hormonal contraceptive) for
<br> at least 1 month prior to Day 1, such as an intrauterine device (IUD), implant, or two
<br> forms of the following: diaphragm, cervical cap, patch, condom, spermicide, or sponge.
<br> In addition, females of child-bearing potential must agree to continue to use their
<br> method of birth control for the duration of the study and 12 weeks following discharge
<br> from the study.
<br>
<br> 3. If male, be surgically sterile, or agree to use appropriate contraception (latex
<br> condom with spermicide) when engaging in sexual activity and agree to not donate sperm
<br> for the duration of the study and 12 weeks following discharge from the study.
<br>
<br> 4. Be in good health (ie, no acute illnesses or hospitalizations within 30 days of the
<br> study start, no planned procedures during study participation, and no newly diagnosed
<br> chronic illnesses that are not deemed stable by the participant's primary care
<br> physician), in the opinion of the Investigator, based on medical history (ie, absence
<br> of any clinically relevant abnormality) during Screening.
<br>
<br> 5. Be able to understand and provide written, informed consent.
<br>
<br> 6. Must have access to the internet and a device that reliability connects to the
<br> internet and is able to dial into Telehealth checkups and study related assessments.
<br>
<br> 7. Must be able to receive study product shipments directly to their home (ie, no Post
<br> Office Boxes).
<br>
<br> Exclusion Criteria:
<br>
<br> Participants who meet any of the following criteria will be excluded from the study.
<br>
<br> 1. Participants with any respiratory infection, flu-like symptoms, or unexplained fever
<br> or chills during the week prior to Screening.
<br>
<br> 2. Participants with any prior history of SARS-CoV-2 infection.
<br>
<br> 3. Participants who have received any dose of SARS-CoV-2 vaccine.
<br>
<br> 4. Participants who use intranasally dosed drugs, prescriptions or over-the-counter
<br> medications such as fluticasone.
<br>
<br> 5. Participants who underwent a previous tracheostomy.
<br>
<br> 6. Participants who are receiving concomitant treatment of respiratory support (involving
<br> any form of oxygen therapy).
<br>
<br> 7. Females who are breastfeeding, pregnant, or attempting to become pregnant.
<br>
<br> 8. Participants who have any other condition that, in the opinion of the Investigator,
<br> would interfere with a participant's ability to adhere to the protocol (eg,
<br> participants whom are mentally or neurologically disabled and whom are considered not
<br> fit to their participation in the study), interfere with assessment of the
<br> investigational product, or compromise the safety of the participant or the quality of
<br> the data.
<br> | | SARS-CoV-2 Infection | Drug: Nitric Oxide;Device: Nasal spray with isotonic saline | To assess the efficacy of NONS in the reduction of risk of COVID-19 infection. | | | | Yes | False | | |
| +++ | NCT05109624 | 15 November 2021 | Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2? | Is Prolonged Period of Prone Position Effective and Safe in Mechanically Ventilated Patients With SARS-COV-2? A Randomized Clinical Trial | | Ain Shams University | 03/11/2021 | 20211103 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05109624 | Recruiting | No | 18 Years | 80 Years | All | October 1, 2021 | 52 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | N/A | Egypt | | Amr Fouad, MD | | amr_foud@med.asu.edu.eg | 01225674370 | |
<br> Inclusion Criteria:
<br>
<br> - - American Society of Anesthesiologists (ASA) physical status II- III.
<br>
<br> - Sex (male and females).
<br>
<br> - Age 18 -80 years.
<br>
<br> - Sever adult respiratory distress (ARDS) (defined as a PaO2:FiO2 ratio of <150 mm Hg,
<br> with a fraction of inspired oxygen (FiO2) of =0.6, a positive end expiratory pressure
<br> (PEEP) of =5 CmH2O, and a tidal volume of 6 ml/Kg of predicted body weight
<br>
<br> - mechanical ventilation for less than 36 hours
<br>
<br> Exclusion Criteria:
<br>
<br> - - Contraindication for prone positioning
<br>
<br> - increased intracranial tension.
<br>
<br> - face trauma or surgery.
<br>
<br> - Recent Deep venous thrombosis
<br>
<br> - Unstable spine, femur, or pelvic fractures
<br>
<br> - Mean arterial pressure < 65 mm Hg
<br>
<br> - Pregnant women
<br>
<br> - Pneumothorax
<br>
<br> - Prone positioning before inclusion
<br>
<br> - Those returned to supine position before completing the session time
<br> | | COVID-19 Acute Respiratory Distress Syndrome | Procedure: prolonged prone position ventilation | rate of successful weaning;Incidence of complications | | | | Yes | False | | |
| +++ | NCT05110560 | 15 November 2021 | Effects of the Programme Developed for Sedentary Elderly in the COVID-19 Pandemic: Mobile Interventional Study | Effects of the "Stay at Home-Take a Step" Programme Developed for Sedentary Elderly in the COVID-19 Pandemic: Mobile Interventional Study | | Namik Kemal University | 06/10/2021 | 20211006 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05110560 | Not recruiting | No | 65 Years | N/A | All | June 1, 2021 | 32 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Outcomes Assessor). | N/A | Turkey | ; | NURHAN ÖZPANCAR;AYLIN YALÇIN IRMAK | | ; | ; | Namik Kemal University;Namik Kemal University |
<br> Inclusion Criteria:
<br>
<br> - Those who volunteered to participate in the study
<br>
<br> - No mental disability,
<br>
<br> - Can read and write Turkish
<br>
<br> - Using a smartphone
<br>
<br> - No muscle-joint problems that interfere with physical activity
<br>
<br> - No neuropsychiatric disorder
<br>
<br> - No cognitive problem that prevents communication
<br>
<br> - Not diagnosed as COVID 19 positive
<br>
<br> - Able to carry out activities of daily living independently
<br>
<br> - All individuals aged 65 and over will be included. Sedentary elderly people who take
<br> an average of 2000 or less steps per day
<br>
<br> Exclusion Criteria:
<br>
<br> - Having insulin-dependent Type 2 diabetes
<br>
<br> - Having hypertension and not being able to control it with medication
<br>
<br> - Being diagnosed with Heart Failure
<br>
<br> - Being diagnosed with chronic obstructive pulmonary disease
<br>
<br> - Being diagnosed with asthma
<br>
<br> - Being diagnosed with cancer
<br> | | Aged | Behavioral: "Stay at Home Take a Step Program (SHTSP)" | Stress level;EuroQoL Quality of Life Scale;Daily steps | | | | Yes | False | | |
| +++ | NCT05110651 | 15 November 2021 | The Danish Pre-HCQ COVID Dialysis Study | The Danish Pre-HCQ Dialysis Study: Hydroxychloroquine for Prevention of COVID19 in Dialysis-treated Patients With End-stage Renal Disease - A Multicenter Parallel-group Open Randomized Clinical Trial | | Nicholas Carlson | 29/03/2020 | 20200329 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05110651 | Not recruiting | No | 18 Years | N/A | All | April 10, 2020 | 0 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 4 | Denmark | | Nicholas Carlson, MD PhD | | | | Rigshospitalet, Denmark |
<br> Inclusion Criteria:
<br>
<br> - Patients =18 years on chronic dialysis due to end-stage renal disease.
<br>
<br> - Competence to understand the study rationale, including potential risks and benefits
<br> associated with treatment, necessary for written informed consent.
<br>
<br> Exclusion Criteria:
<br>
<br> - Prior verified SARS-CoV-2 infection.
<br>
<br> - Hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines
<br>
<br> - Electrocardiogram with QTc (Bazett's formula) > 450 ms in males and 460 ms in females
<br>
<br> - Patients reliant on digoxin or amiodarone treatment
<br>
<br> - Pre-existing psoriasis
<br>
<br> - Any pre-existing maculopathy with vision reduction
<br>
<br> - Prior sensorineural hearing loss
<br>
<br> - Pre-existing severe liver insufficiency (spontaneous international normalized ratio
<br> >1.5 within the last year)
<br>
<br> - Pre-existing epileptic disease requiring anti-epileptic medication
<br>
<br> - Pregnancy or lactation
<br>
<br> - Insurmountable Language Barrier
<br>
<br> - Participation in other ongoing intervention trials investigating COVID19-related
<br> outcomes
<br> | | COVID-19;End Stage Renal Disease | Drug: Hydroxychloroquine | Hospitalization due to SARS-CoV-2 infection | | | | Yes | False | | |
| +++ | NCT05110859 | 15 November 2021 | QUALITATIVE SURVEY ABOUT NURSES FIRST WORK EXPERIENCE DURING COVID-19 PANDEMIC | PHENOMENOLOGICAL QUALITATIVE SURVEY ABOUT NURSES FIRST WORK EXPERIENCE DURING COVID-19 PANDEMIC AT PIACENZA HOSPITAL, ITALY | | Azienda Unità Sanitaria Locale di Piacenza | 05/11/2021 | 20211105 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05110859 | Recruiting | No | 18 Years | N/A | All | November 2, 2021 | 20 | Observational | | | Italy | ; | Maurizio Beretta, RN;Maurizio Beretta, RN | | m.beretta@ausl.pc.it;m.beretta@ausl.pc.it | 0523 303856;0523 303852 | |
<br> Inclusion Criteria:
<br>
<br> - Adults
<br>
<br> - first work experience nurses after gratuation
<br>
<br> - not opposed to partecipate to this study
<br>
<br> Exclusion Criteria:
<br>
<br> - refusing to partecipate
<br> | | Quality of Life | Other: in-depth individual interviews | nurses satisfaction | | | | Yes | False | | |
| +++ | NCT05110911 | 15 November 2021 | Does Repeat Influenza Vaccination Constrain Influenza Immune Responses and Protection | Does Repeat Influenza Vaccination Constrain Influenza Immune Responses and Protection | | University of Melbourne | 27/10/2021 | 20211027 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05110911 | Recruiting | No | 18 Years | 60 Years | All | April 2, 2020 | 1500 | Observational | | | Australia | ; ; ; | Sheena Sullivan, MPH, PhD;Annette Fox, PhD;Adam Kucharski, MMath, PhD;Sheena Sullivan, MPH, PhD | | ;;;sheena.sullivan@influenzacentre.org | ;;;+61 3 9342 9317 | University of Melbourne;University of Melbourne;London School of Hygiene and Tropical Medicine; |
<br> Inclusion Criteria:
<br>
<br> Eligible participants will be recruited from 1 of 6 participating hospitals and will meet
<br> the following criteria:
<br>
<br> - Personnel (including staff, honorary staff, students and volunteers) located at a
<br> participating hospital or healthcare service at the time of recruitment who would be
<br> eligible for the hospital's free vaccination programme
<br>
<br> - Be aged =18 years old and =60 years old;
<br>
<br> - Have a mobile phone that can receive and send SMS messages;
<br>
<br> - Willing and able to provide blood samples;
<br>
<br> - Available for follow-up over the next 7 months;
<br>
<br> - Able and willing to complete the informed consent process.
<br>
<br> There are no restrictions on the type of healthcare worker (HCW) that can be recruited into
<br> the study in terms of their job role. HCWs can be any hospital staff, including clinical,
<br> research, administrative and support staff.
<br>
<br> Exclusion Criteria:
<br>
<br> - Immunosuppressive treatment (including systemic corticosteroids) within the past 6
<br> months;
<br>
<br> - Personnel for whom vaccination is contraindicated at the time of recruitment.
<br> | | Influenza, Human;SARS-CoV-2 Infection | Biological: Influenza vaccination: Fluarix Tetra, Vaxigrip Tetra, Fluquadri, Fluad Quad, Afluia Quad, Flucelvax Quad;Biological: SARS-CoV-2 vaccination: Comirnaty or Vaxzevria | Seropositivity post-vaccination (influenza vaccine);Seropositivity post-season (influenza vaccine);Fold-rise in geometric mean antibody titre (GMT) pre- to post-vaccination;Fold-change in geometric mean antibody titre (GMT) post-vaccination to post-season;Seroconversion fraction post-vaccination | | | | No | False | | |
| +++ | NCT05112848 | 15 November 2021 | A Study to Evaluate Safety and Immunogenicity of a COVID-19 Vaccine in People Living With HIV at Risk for SARS-CoV-2 (COVID-19) | A Phase 2, Randomized, Observer-Blinded Study to Evaluate the Safety and Immunogenicity of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine (SARS-CoV-2 rS) With Matrix-M™ Adjuvant in People Living With HIV | COVID-19 | Novavax | 25/10/2021 | 20211025 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05112848 | Not recruiting | No | 18 Years | 65 Years | All | November 2021 | 360 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | | | Chijioke Bennett, MD | | cbennett@novavax.com | +1 (240) 661-8140 | |
<br> Inclusion Criteria:
<br>
<br> 1. Adults 18 to 65 years of age, inclusive, at screening.
<br>
<br> 2. Willing and able to give informed consent prior to study enrollment and to comply with
<br> study procedures.
<br>
<br> 3. Participants of childbearing potential (defined as any participant who has experienced
<br> menarche and who is NOT surgically sterile [ie, hysterectomy, bilateral tubal
<br> ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least
<br> 12 consecutive months]) must agree to be heterosexually inactive from at least 28 days
<br> prior to enrollment and through the end of the study OR agree to consistently use a
<br> medically acceptable method of contraception listed below from at least 28 days prior
<br> to enrollment and through the end of the study.
<br>
<br> 1. Condoms (male or female) with spermicide (if acceptable in-country)
<br>
<br> 2. Diaphragm with spermicide
<br>
<br> 3. Cervical cap with spermicide
<br>
<br> 4. Intrauterine device
<br>
<br> 5. Oral or patch contraceptives
<br>
<br> 6. Norplant®, Depo-Provera®, or other in-country regulatory approved contraceptive
<br> method that is designed to protect against pregnancy.
<br>
<br> 7. Abstinence as a form of contraception is acceptable if in line with the
<br> participant's lifestyle.
<br>
<br> 4. Vital signs must be within medically acceptable ranges prior to the first vaccination
<br>
<br> 5. Agree to not participate in any other SARS-CoV-2 prevention or treatment trials for
<br> the duration of the study.
<br>
<br> For well-controlled PLWH
<br>
<br> 6. PLWH with a cluster of differentiation 4 (CD4) + T-cell count of = 350 cells/µL at
<br> screening or viral load of = 1,000 copies/mL.
<br>
<br> 7. PLWH being managed on a stable/unchanged antiretroviral therapy (ART) regimen for at
<br> least 2 months prior to enrollment.
<br>
<br> 8. No opportunistic infections in the past year.
<br>
<br> For less-well-controlled PLWH
<br>
<br> 9. PLWH with a CD4+ T-cell count of = 200 and < 350 cells/µL at screening or viral load
<br> of 1,000 to 10,000 copies/mL.
<br>
<br> 10. PLWH being managed on a stable/unchanged (ART) regimen for at least 1 month prior to
<br> enrollment.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Laboratory-confirmed SARS-CoV-2 infection (polymerase chain reaction + within 5 days
<br> prior to first study vaccination with results available before randomization) or
<br> positive serology (eg, anti-nucleocapsid or anti-S protein antibody) to SARS-CoV-2
<br> infection at any time prior to randomization.
<br>
<br> 2. Previous receipt of any investigational or authorized/approved vaccine, prophylactic
<br> or therapeutic agent for the prevention or treatment of COVID-19.
<br>
<br> 3. Participation in research involving receipt of an investigational product
<br> (drug/biologic/device) within 90 days prior to the first study vaccination.
<br>
<br> 4. Received influenza vaccination within 14 days prior to first study vaccination, or any
<br> other vaccine within 30 days prior to first study vaccination.
<br>
<br> 5. Any known allergies to products contained in the investigational product.
<br>
<br> 6. Any history of anaphylaxis to any prior vaccine.
<br>
<br> 7. Autoimmune or immunodeficiency disease/condition (iatrogenic or congenital) requiring
<br> ongoing immunomodulatory therapy.
<br>
<br> 8. Chronic administration (defined as > 14 continuous days) of immunosuppressant,
<br> systemic glucocorticoids, or other immune-modifying drugs within 90 days prior to
<br> first study vaccination.
<br>
<br> 9. Received immunoglobulin, blood-derived products, or immunosuppressant drugs within 90
<br> days prior to first study vaccination.
<br>
<br> 10. Active cancer (malignancy) on therapy within 3 years prior to first study vaccination
<br> (with the exception of adequately treated non-melanomatous skin carcinoma or lentigo
<br> maligna and uterine cervical carcinoma in situ without evidence of disease, at the
<br> discretion of the investigator).
<br>
<br> 11. Participants who are breastfeeding, pregnant, or who plan to become pregnant prior to
<br> the end of study.
<br>
<br> 12. Suspected or known history of alcohol abuse or drug addiction within 2 years prior to
<br> the first study vaccine dose that, in the opinion of the investigator, might interfere
<br> with protocol compliance.
<br>
<br> 13. Any other condition that, in the opinion of the investigator, would pose a health risk
<br> to the participant if enrolled or could interfere with evaluation of the trial vaccine
<br> or interpretation of study results (including neurologic or psychiatric conditions
<br> likely to impair the quality of safety reporting).
<br>
<br> 14. Study team member or immediate family member of any study team member (inclusive of
<br> Sponsor, Contract Research Organization, and study site personnel involved in the
<br> conduct or planning of the study).
<br> | | SARS-CoV-2 Infection | Biological: NVX-CoV2373 | Serum IgG antibody levels expressed as geometric mean fold rise (GMFR);Serum IgG antibody levels expressed as geometric mean fold rise (GMFR);Serum IgG antibody levels expressed as seroconversion rate (SCR);Serum IgG antibody levels expressed as seroconversion rate (SCR);Serum IgG antibody levels expressed as seroconversion rate (SCR);Serum IgG antibody levels expressed as seroconversion rate (SCR);Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT);Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT);Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT);Human angiotensin-converting enzyme 2 (hACE2) receptor binding inhibition assay expressed as geometric mean titer (GMT);hACE2 receptor binding inhibition assay expressed as GMFR;Serum IgG antibody levels expressed as geometric mean fold rise (GMFR);Serum IgG antibody levels expressed as geometric mean fold rise (GMFR);Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU);Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU);Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU);Serum Immunoglobulin (IgG) antibody levels expressed as geometric mean enzyme-linked immunosorbent assay units (GMEU);Number of HIV-Negative participants with solicited local AEs;Number of HIV-Negative participants with solicited local AEs;Number of HIV-Negative participants with solicited local AEs;Number of PLWH with solicited local AEs;Number of PLWH with solicited local AEs;Number of PLWH with solicited local AEs;Number of HIV-Negative participants with solicited systemic AEs;Number of HIV-Negative participants with solicited systemic AEs;Number of HIV-Negative participants with solicited systemic AEs;Number of PLWH with solicited systemic AEs;Number of PLWH with solicited systemic AEs;Number of PLWH with solicited systemic AEs;Number of HIV-Negative participants with unsolicited AEs;Number of HIV-Negative participants with unsolicited AEs;Number of PLWH with unsolicited AEs;Number of PLWH with unsolicited AEs;Number of HIV-Negative participants with unsolicited AEs;Number of PLWH with unsolicited adverse events (AEs);hACE2 receptor binding inhibition assay expressed as GMFR;hACE2 receptor binding inhibition assay expressed as GMFR;hACE2 receptor binding inhibition assay expressed as GMFR;hACE2 receptor binding inhibition assay expressed as SCR;hACE2 receptor binding inhibition assay expressed as SCR;hACE2 receptor binding inhibition assay expressed as SCR;hACE2 receptor binding inhibition assay expressed as SCR;Neutralizing antibody activity expressed as GMT;Neutralizing antibody activity expressed as GMT;Neutralizing antibody activity expressed as SCR;Neutralizing antibody activity expressed as SCR;Neutralizing antibody activity expressed as GMFR;Neutralizing antibody activity expressed as GMFR | | | | Yes | False | | |
| +++ | NCT05112874 | 15 November 2021 | ImmuneSense™ COVID-19 Cross-Reactivity Study | ImmuneSense™ COVID-19 Cross-Reactivity Study | | Adaptive Biotechnologies | 27/10/2021 | 20211027 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05112874 | Not recruiting | No | 18 Years | 89 Years | All | November 2021 | 10 | Observational | | | | ; | Sudeb Dalai;Jia Qadeer | | ;jqadeer@adaptivebiotech.com | ;2066006761 | Adaptive Biotechnologies; |
<br> Inclusion Criteria:
<br>
<br> 1. Exhibiting viral upper respiratory infection symptoms during the symptomatic phase of
<br> infection and tested positive for a common seasonal coronavirus (NL63, 229E, OC43, and
<br> HKU1) at time of diagnosis for initial symptoms
<br>
<br> 2. Available for specimen collection greater than 14 days and less than 100 days after
<br> first exhibiting symptoms of confirmed seasonal coronavirus infection.
<br>
<br> 3. Male and female participants of any race and ethnicity between 18 to 89 years of age
<br> (inclusive) at the time of enrollment in the study
<br>
<br> 4. Able to communicate with the investigator, understand, and comply with the
<br> requirements of the study
<br>
<br> Exclusion criteria:
<br>
<br> 1. Did not develop symptoms related to their diagnosed seasonal coronavirus infection
<br>
<br> 2. Prior diagnosis of COVID-19 or any positive test result for SARS-CoV-2 infection or
<br> antibodies test
<br>
<br> 3. Cohabitated with or has had significant exposure (per the Center for Disease Control
<br> guidelines) to another individual with known COVID-19
<br>
<br> 4. Protected populations including pregnant women, prisoners, mentally disabled persons,
<br> and wards-of-the state.
<br>
<br> 5. Any significant condition, laboratory abnormality, or psychiatric illness that would
<br> prevent the participant from safely participating in the study
<br>
<br> 6. Donated more than 500cc or 1 pint of blood in the past 60 days prior to the study
<br> blood draw
<br>
<br> 7. Received a COVID-19 vaccine, including a single dose of a multiple dose vaccine
<br> regimen
<br>
<br> 8. Participated in a COVID-19/SARS-CoV-2 study or received a SARS-CoV-2 antibody, or
<br> other SARS-CoV-2 therapeutic investigational drug or compound that will impact results
<br> of the study at the discretion of the investigator, such as but not limited to a
<br> SARS-CoV-2 antibody, therapeutic, or other medication that may impact the person's
<br> immune response
<br> | | Coronavirus Disease;SARS-CoV-2 Infection | | Primary Objective | | | | Yes | False | | |
| +++ | NCT05112887 | 15 November 2021 | Osteopathic Manipulative Therapy Effects on Prolonged Post-COVID Olfactory Dysfunction | Osteopathic Manipulative Therapy Effects on Prolonged Post-COVID Olfactory Dysfunction | | Ohio University | 05/11/2021 | 20211105 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05112887 | Not recruiting | No | 18 Years | N/A | All | March 31, 2021 | 20 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). | N/A | United States | | Steven Walkowski, DO | | | | Ohio University |
<br> Inclusion Criteria:
<br>
<br> - 18 years or older
<br>
<br> - Positive COVID test greater than 14 days prior
<br>
<br> - Self-identify a decrease in smell after the resolution of their infection
<br>
<br> Exclusion Criteria:
<br>
<br> - Complete smell recovery after resolution of infection
<br> | | COVID-19 Lower Respiratory Infection;SARS-CoV2 Infection | Other: Osteopathic Manipulative Therapy | Smell Intensity;Smell Identification | | | | Yes | False | | |
| +++ | NCT05112900 | 15 November 2021 | Health Information Technology for COVID-19 Testing in Schools (SCALE-UP Counts) | SCALE-UP Counts: A Health Information Technology Approach to Increasing COVID-19 Testing in Elementary and Middle Schools Serving Disadvantaged Communities | | University of Utah | 01/11/2021 | 20211101 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05112900 | Not recruiting | No | N/A | N/A | All | November 2021 | 20000 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Screening. Masking: None (Open Label). | Phase 3 | United States | ; ; | Yelena Wu, PhD;Leighann Kolp;Leighann Kolp | | ;leighann.kolp@hci.utah.edu;leighann.kolp@hci.utah.edu | ;801-646-4206;801-646-4206 | University of Utah; |
<br> Inclusion Criteria:
<br>
<br> Students
<br>
<br> - Attends school at any of the participating schools from the districts the research
<br> team is working with
<br>
<br> Parents
<br>
<br> - Legal guardian/parent of the student
<br>
<br> - Has a functioning cellular phone that can receive calls and text messages
<br>
<br> School Staff
<br>
<br> - Works at any of the participating schools from the districts the research team is
<br> working with
<br>
<br> Exclusion Criteria:
<br>
<br> - None
<br> | | COVID-19 | Behavioral: Text Messaging (TM);Behavioral: Text Messaging + Health Navigation (TM+HN) | Change in Testing Uptake | | | | Yes | False | | |
| +++ | NCT05112913 | 15 November 2021 | Lot-to-lot Consistency of an Inactivated SARS-CoV-2 Vaccine Between Different Workshops in Healthy Children Aged 3-17 Years | A Double-blind, Randomized Clinical Trial to Evaluate the Lot-to-lot Consistency, Immunogenicity and Safety of an Inactivated SARS-CoV-2 Vaccine (CoronaVac)Between Different Workshops for Prevention of COVID-19 in Healthy Children Aged 3-17 Years | | Sinovac Biotech Co., Ltd | 08/11/2021 | 20211108 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05112913 | Recruiting | No | 3 Years | 17 Years | All | July 27, 2021 | 2520 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Double (Participant, Investigator). | Phase 4 | China | ; ; | Weijun Hu, Master;Weijun Hu, Master;Dan Liu | | ;huweijun0828@163.com;494183915@qq.com | ;029-82231502;19991212093 | Shanxi Provincial Center for Disease Prevention and Control; |
<br> Inclusion Criteria:
<br>
<br> - Healthy children aged 3-17;
<br>
<br> - The subjects and/or guardians can understand and voluntarily sign the informed consent
<br> form (For subjects aged 8-17 years, both subjects and guardians need to sign the
<br> informed consent form)
<br>
<br> - Proven legal identity.
<br>
<br> Exclusion Criteria:
<br>
<br> - History of SARS-CoV-2 infection;
<br>
<br> - History of receiving COVID-19 vaccine;
<br>
<br> - History of asthma, history of allergy to the vaccine or vaccine components, or serious
<br> adverse reactions to the vaccine, such as urticaria, dyspnea,and angioedema;
<br>
<br> - Congenital malformations or developmental disorders, genetic defects, severe
<br> malnutrition, etc.;
<br>
<br> - Autoimmune disease (Systemic lupus erythematosus)or immunodeficiency /
<br> immunosuppression(HIV,history after organ transplantation)
<br>
<br> - Severe chronic diseases, severe cardiovascular diseases, hypertension and diabetes
<br> that cannot be controlled by drugs, liver or kidney diseases, malignant tumors, etc.;
<br>
<br> - Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
<br>
<br> - Thyroid disease or history of thyroidectomy,absence of spleen, functional absence of
<br> spleen, absence of spleen due to any condition or splenectomy;
<br>
<br> - Diagnosed abnormal blood coagulation function (eg, lack of blood coagulation factors,
<br> blood coagulopathy, abnormal platelets) or obvious bruising or blood coagulation;
<br>
<br> - Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids (excluding
<br> allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis
<br> superficial corticosteroid therapy) in the past 6 months;
<br>
<br> - Receipt of blood products within in the past 3 months;
<br>
<br> - Receipt of other investigational drugs in the past 30 days;
<br>
<br> - Receipt of attenuated live vaccines in the past 14 days;
<br>
<br> - Receipt of inactivated or subunit vaccines in the past 7 days;
<br>
<br> - Onset of various acute or chronic diseases within 7 days prior to the study;
<br>
<br> - Axillary temperature >37.0°C;
<br>
<br> - The subjects participated in other clinical trials during the follow-up period, or
<br> will be planned within 3 months;
<br>
<br> - Already pregnant (including a positive urine pregnancy test) or are breastfeeding,
<br> planning to get pregnant within 2 months;
<br>
<br> - According to the investigator's judgment, the subject has any other factors that are
<br> not suitable for participating in the clinical trial.
<br> | | COVID-19 | Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 2;Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 2;Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 2;Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 3;Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 2 of the workshop 3;Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 3 of the workshop 3;Biological: Inactivated SARS-CoV-2 Vaccine (Vero cell) Lot 1 of the workshop 1 | Geometric mean titer(GMT) of neutralizing antibody to live SARS-CoV-2 | | | | Yes | False | | |
| +++ | NCT05113472 | 15 November 2021 | Adverse Reactions Following COVID-19 Vaccination Among Ecuadorian Healthcare Workers | Adverse Reactions Following COVID-19 Vaccination: an Ecuadorian Experience | | Respiralab | 08/11/2021 | 20211108 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05113472 | Not recruiting | No | 18 Years | 99 Years | All | March 1, 2021 | 1291 | Observational | | | Ecuador | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Ecuadorian nationality
<br>
<br> - Active practice in the medical field
<br>
<br> - Received the Pfizer-BioNTech COVID-19 vaccine
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients who voluntarily refused to participate.
<br> | | Adverse Drug Event | Biological: Pfizer-BioNTech COVID-19 vaccine | Adverse reactions | | | | Yes | False | | |
| +++ | NCT05113784 | 15 November 2021 | the Safety and Efficacy of Meplazumab in Patients With COVID-19 | A Multicenter, Double-blind, Randomized Controlled, add-on Phase 2/3 Study of the Safety and Efficacy of Meplazumab in Patients With COVID-19 | | Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd | 17/09/2021 | 20210917 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05113784 | Not recruiting | No | 18 Years | 75 Years | All | December 2021 | 150 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 2/Phase 3 | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - 18 years =Subject = 75 years, Male and/or female;
<br>
<br> - Clinical confirmation of COVID-19 patients in accordance with novel Coronavirus
<br> Diagnosis and Treatment Protocol (Trial Version 8) of the NHC
<br>
<br> - Participants must be able to understand and willing to participate in this research,
<br> this study and signed informed consent form (if incapacitated subjects, the
<br> researchers believe the subjects to the test in its own interests, should be signed by
<br> its legal guardian informed consent, or telephone inform consent (recording) and note
<br> it in the original medical records and other relevant documents)
<br>
<br> Exclusion Criteria:
<br>
<br> - Subjects with any unstable conditions, a history of significant hypersensitivity, or
<br> known allergy to components of the investigational agent;
<br>
<br> - SARS-CoV-2 infection by PCR = 96h;
<br>
<br> - Platelet (PLT) < 50×10^9/L, or hemoglobin (HGB) < 60g/L;
<br>
<br> - Total bilirubin (TBIL) > 2×ULN (upper limit of normal value), or alanine transferase
<br> (ALT), aspartate transferase (AST), alkaline phosphatase (ALP) > 5×ULN;
<br>
<br> - glomerular filtration rate (GFR) < 30mL/min·1.73m^2, or serum creatinine increased by
<br> 0.5mg/ dL within 7 days, or oliguria (<400mL/24hr), or anuria (<100mL/24hr);
<br>
<br> - Pregnant or breast feeding;
<br>
<br> - Persons who have family planning or do not agree to use effective non-drug
<br> contraceptive measures within 6 months after signing the ICF;
<br>
<br> - Subjects participating in another clinical study. There will be a need for washout
<br> with 5 half lives depending on the study treatment or 30 days since any previous
<br> study, whichever is longer;
<br>
<br> - he inestigators concluded that the patients had other reasons for not being eligible
<br> for the study.
<br> | | Covid19 | Drug: Meplazumab for Injection;Drug: Sterile normal saline (0.9%) | Time of virus nucleic acid test turning negative | | | | Yes | False | | |
| +++ | NCT05113810 | 15 November 2021 | The Potential Use of Nebulized Hydroxychloroquine for the Treatment of COVID-19 | A Pilot, Randomized, Open-label Trial to Determine the Feasibility, Safety, Efficacy, and Pharmacokinetics of Nebulized HCQ01for the Treatment of Patients With COVID-19 | | Ministry of Health Jordan | 06/11/2021 | 20211106 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05113810 | Not recruiting | No | 18 Years | N/A | All | December 4, 2021 | 110 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Phase 2 | | ; | Feras Hawari, MD;Yasmeen Dodin, MSc | | ;YD.14502@KHCC.JO | ;00962798950958 | The Jordanian Ministry of Health; |
<br> Inclusion Criteria:
<br>
<br> 1. Pregnant (positive ß-human chorionic gonadotropin test, ß-HCG) or lactating female at
<br> screening.
<br>
<br> 2. Patients with a history of retinopathy, sickle cell disease or trait, psoriasis,
<br> porphyria, history of splenectomy, mental illness or uncontrolled seizures disorder,
<br> known active tuberculosis or history of incompletely treated tuberculosis, patients on
<br> chronic immunosuppression for other medical conditions such as rheumatological
<br> disorders, inflammatory bowel disease, or in patients with organ transplants.
<br>
<br> 3. Patients admitted in ICU.
<br>
<br> 4. Taking medications which may lead to interactions with hydroxychloroquine, including
<br> penicillamine, telbivudine, botulinum toxin, fluconazole, digoxin, propafenone ,
<br> cimetidine, statins, warfarin, and cyclosporine within 2 weeks of dosing start, and
<br> during the duration of the study.
<br>
<br> 5. History of Glucose-6-phosphate dehydrogenase deficiency.
<br>
<br> 6. Pre-treatment corrected QT interval (QTc) =450 milliseconds.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnant (positive ß-human chorionic gonadotropin test, ß-HCG) or lactating female at
<br> screening.
<br>
<br> 2. Patients with a history of retinopathy, sickle cell disease or trait, psoriasis,
<br> porphyria, history of splenectomy, mental illness or uncontrolled seizures disorder,
<br> known active tuberculosis or history of incompletely treated tuberculosis, patients on
<br> chronic immunosuppression for other medical conditions such as rheumatological
<br> disorders, inflammatory bowel disease, or in patients with organ transplants.
<br>
<br> 3. Patients admitted in ICU.
<br>
<br> 4. Taking medications which may lead to interactions with hydroxychloroquine, including
<br> penicillamine, telbivudine, botulinum toxin, fluconazole, digoxin, propafenone ,
<br> cimetidine, statins, warfarin, and cyclosporine within 2 weeks of dosing start, and
<br> during the duration of the study.
<br>
<br> 5. History of Glucose-6-phosphate dehydrogenase deficiency.
<br>
<br> 6. Pre-treatment corrected QT interval (QTc) =450 milliseconds.
<br>
<br> 7. Acute or chronic kidney disease (stage-4 or -5 renal impairment; eGFR<30 mL/min/1.73
<br> m2 or hemodialysis).
<br>
<br> 8. Liver Child-Pugh grade C.
<br>
<br> 9. Patients with Hypokalemia (<3.5mmol/L), Hypocalcemia (<2.2mmol/L), Hypomagnesemia
<br> (<0.66mmol/L). Will be included after correction.
<br>
<br> 10. Need for mechanical ventilation.
<br>
<br> 11. History of hypersensitivity to hydroxychloroquine.
<br>
<br> 12. History of Chronic Hepatitis B or hepatitis C infections.
<br>
<br> 13. History of Human Immunodeficiency Virus (HIV) infection.
<br>
<br> 14. Concurrent serious illness including, but not limited to, any of the following:
<br>
<br> - Clinically significant cardiovascular disease (e.g., uncontrolled hypertension,
<br> myocardial infarction, or unstable angina).
<br>
<br> - New York Heart Association class II-IV congestive heart failure.
<br>
<br> - Serious cardiac arrhythmia requiring medication. -Peripheral vascular disease =
<br> grade 2 within the past year. -
<br>
<br> - Psychiatric illness/social situation that would limit compliance with study
<br> requirements. -COPD, Lung cancer, and moderate to severe asthma.
<br>
<br> 15. Any other significant finding based on the judgment of the PI would increase the risk
<br> of having an adverse outcome from participating in this study.
<br>
<br> 16. Any other concomitant treatment based on the judgment of the PI would increase the
<br> risk of having an adverse outcome from participating in this study.
<br>
<br> 17. Is currently participating in or has participated in an interventional clinical trial
<br> with an investigational compound or device within 80 days of signing the informed
<br> consent/assent for this current trial.
<br> | | 2019 Novel Coronavirus | Drug: HCQ01;Other: standard of care (SOC) for COVID-19 | Proportion of participants who improve by at least one level lower on the 11-point World Health Organization Ordinal Scale for Clinical Improvement (WHO-OSCI), where patients are scored on a scale of 0-10 with 0 being uninfected and 10 being dead;Feasibility Indicator: Recruitment (Proportion of participants enrolled in the study);Feasibility Indicator: Recruitment retention (Proportion of consented participants that complete the study;Feasibility Indicator: related to IMP and deviations (Feasibility endpoints include protocol deviations in terms of timing and delivery of scheduled medication) | | | | Yes | False | | |
| +++ | NCT05113823 | 15 November 2021 | In Situ Simulation Training in Transferring Critically Ill COVID-19 Patients | In Situ Simulation Training for a Better Interprofessional Team Performance in Transferring Critically Ill COVID-19 Patients: A Prospective Randomized Control Trial | | Indonesia University | 25/10/2021 | 20211025 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05113823 | Not recruiting | No | 20 Years | 65 Years | All | November 16, 2020 | 40 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Health Services Research. Masking: Single (Investigator). | N/A | Indonesia | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - in good physical condition
<br>
<br> - had no history of involving in COVID-19 patients care
<br>
<br> - willing to become study subject
<br>
<br> Exclusion Criteria:
<br>
<br> - doesn't want to become study subject
<br> | | Simulation of Physical Illness;COVID-19 Respiratory Infection | Procedure: Simulation Training | rate of interprofessional communication;rate of skill;rate of team work | | | | No | False | | |
| +++ | NCT05113849 | 15 November 2021 | Study to Evaluate the Safety and Immunogenicity of SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults (COVID-19) | A Phase 1, Open-label, Dose-escalation Study to Assess the Safety, Reactogenicity, and Immunogenicity of a SARS-CoV-2 Vaccine (IN-B009) in Healthy Adults Aged at 19 to 55 Years | | HK inno.N Corporation | 29/10/2021 | 20211029 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05113849 | Recruiting | No | 19 Years | 55 Years | All | September 16, 2021 | 40 | Interventional | Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 1 | Korea, Republic of | ; ; ; | In Jin Jang;Min Geol Kim;Jun Ki Hwang;Naree Shin, MS | | ;;;naree.shin@inno-n.com | ;;;+82-2-6477-0271 | Seoul National University Hospital;Jeonju National University Hospital;Chungbuk National University Hospital; |
<br> Inclusion Criteria:
<br>
<br> - Male or female participants between the ages of 18 and 55 years.
<br>
<br> - Participants considered 'healthy' to be eligible for study participation.
<br>
<br> - Participants who are willing and able to comply with all scheduled visits and other
<br> study procedures.
<br>
<br> - Participants with Body mass index (BMI) within the normal range.
<br>
<br> - Participants with deltoid muscle capable of IP injection.
<br>
<br> - Those that agreed to using medically approved contraception.
<br>
<br> - Female participants with potential pregnancy- Those that used medically approved
<br> contraception and has negative result at the pregnancy test.
<br>
<br> - Capable of giving personal signed informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Clinically significant symptoms prior to IP injection.
<br>
<br> - Confirmed to be COVID-19 RT-PCR positive or to have made close contact with SARS-CoV-2
<br> infected patient.
<br>
<br> - History of virologically-confirmed SARS, MERS, or COVID-19.
<br>
<br> - History of congenital or acquired immunodeficiency or autoimmune diseases.
<br>
<br> - Positive result of hepatitis B, C, RPR test, or HIV.
<br>
<br> - History of disorder that inhibits intramuscular injection of the vaccine.
<br>
<br> - History of hypersensitivity and severe allergic reaction to any of the components of
<br> IP.
<br>
<br> - History of malignant tumor within 5 years prior to the first IP injection.
<br>
<br> - Clinically significant chronic diseases that could cause safety concerns regarding
<br> COVID-19.
<br>
<br> - Scheduled of , or history of surgery under general anaesthesia prior to first IP
<br> injection,
<br>
<br> - Female participant that is pregnant or is currently breastfeeding.
<br>
<br> - Smoker or history of smoking within 12 weeks prior to first IP injection.
<br>
<br> - Previous vaccination or treatment for prevention of COVID-19.
<br>
<br> - Vaccination prior to the first IP injection or scheduled of vaccination after second
<br> IP injection.
<br>
<br> - Treated with immunoglobulin and/or blood/blood components prior to first IP injection.
<br>
<br> - Chronic use of immunosuppressant prior to first IP injection.
<br>
<br> - Participated in other clinical study prior to first IP injection, or scheduled to
<br> participate in other study during the study period.
<br>
<br> - Healthcare worker or emergency response personnel.
<br>
<br> - Conditions that may influence the evaluation of the study objectives.
<br> | | COVID-19 | Biological: IN-B009 (Low-dose);Biological: IN-B009 (High-dose) | Occurrence rate of Immediate Adverse Reaction (IAR);Occurrence rate of solicited local and systemic AE;Occurrence rate of unsolicited AE;Occurrence rate of SAEs, MAAEs, AESIs;GMT of Anti-SAS-CoV-2 RBD IgG measured with ELISA;GMFR of Anti-SAS-CoV-2 RBD IgG from baseline measured with ELISA;Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in IgG titer;GMT of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay;GMFR of Neutralizing anti-SARS-CoV-2 measured with live virus neutralization assay;Proportion of participants achieving a greater than or equal to 4-fold rise from baseline in wild-type neutralizing antibody titer;Cell-mediated response | | | | Yes | False | | |
| +++ | NCT05113862 | 15 November 2021 | Evaluation of Safety and Immunogenicity of a T-Cell Priming Peptide Vaccine Against Coronavirus | A Phase-I, Double-blind, Randomized, Vehicle-controlled, Dose-finding, Safety Study of a Synthetic Nanoparticle-based, T Cell Priming Peptide Vaccine Against Coronavirus in Healthy Adults in Switzerland | naNO-COVID | Emergex Vaccines Holding Ltd. | 05/11/2021 | 20211105 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05113862 | Recruiting | No | 18 Years | 45 Years | All | November 2021 | 26 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1 | Switzerland | ; ; | Blaise Genton, Prof.;Blaise Genton, Prof.;Blaise Genton, Prof. | | ;blaise.genton@unisante.ch;blaise.genton@unisante.ch | ;+41 785565868;+41 785565868 | Center for Primary Care and Public Health (Unisante), University of Lausanne, Switzerland; |
<br> Inclusion Criteria:
<br>
<br> - Aged 18 to 45 years on the day of inclusion
<br>
<br> - Participant signed informed consent
<br>
<br> - Residing in Switzerland
<br>
<br> Exclusion Criteria:
<br>
<br> - Participant is pregnant, lactating or of childbearing potential
<br>
<br> - Participation in the 4 weeks preceding the first trial vaccination or planned
<br> participation during the present trial period in another clinical trial investigating
<br> a vaccine, drug, medical device or medical procedure.
<br>
<br> - Receipt of any vaccine (including vaccine against COVID) in the 4 weeks preceding the
<br> first trial vaccination (excluding influenza vaccination which may be received 2 weeks
<br> prior to the first vaccination), or planned receipt of any vaccine in the 4 weeks
<br> following each trial vaccination.
<br>
<br> - Positive SARS-CoV2 test in the 4 weeks preceding the first trial vaccination.
<br>
<br> - Receipt of immunoglobins, blood or blood-derived products in the past 3 months.
<br>
<br> - Known, or suspected congenital or acquired immunodeficiency; or receipt of
<br> immunosuppressive therapy.
<br>
<br> - Self-reported or documented seropositivity for human immunodeficiency virus (HIV),
<br> hepatitis B natural infection, (HBcAb positive serology) or hepatitis C.
<br>
<br> - Known systemic hypersensitivity to any of the vaccine components (e.g gold,) or
<br> history of a life-threatening reaction to vaccines.
<br>
<br> - Current alcohol abuse or drug addiction (reported or suspected)
<br>
<br> - Chronic illness that, in the opinion of the investigator, is at a stage where it might
<br> interfere with trial conduct or completion.
<br>
<br> - Thrombocytopenia or any coagulation disorder
<br>
<br> - Identified as an Investigator or employee of the Investigator or study centre with
<br> direct involvement in the proposed study, or identified as an immediate family member
<br> (i.e parent, spouse, natural or adopted child) of the Investigator or employee with
<br> direct involvement in the proposed study (i.e in the employment of the Tropivac Clinic
<br> or DFRI unit at Unisante).
<br>
<br> - Refusal to be informed in the event that relevant results concerning the participant's
<br> health are revealed.
<br>
<br> The following events constitute contraindications to the administration of the
<br> investigational product on the day of planned vaccination: The participant must be followed
<br> until resolution of the event as with any medical event and may be considered for
<br> vaccination at a later date (maximum 14 days later) or withdrawn at the discretion of the
<br> Investigator. Delays due to these events do not constitute a protocol deviation.
<br>
<br> - Temperature of >37.5°C at the time of vaccination
<br>
<br> - Acute disease at the time of vaccination (defined as the presence of a moderate or
<br> severe illness with or without fever according to investigator's judgment. All
<br> vaccines can be administered to persons with a minor illness such as diarrhoea, mild
<br> upper respiratory infection with or without low-grade febrile illness, i.e. axillary
<br> temperature of = 37.5°C).
<br> | | Coronavirus;SARS-CoV-2 Infection;COVID-19 | Biological: LD Vehicle-GNP;Biological: LD PepGNP-SARSCoV2;Biological: HD Vehicle-GNP;Biological: HD PepGNP-SARSCoV2 | Safety: Solicited local and systemic AEs;Safety: Unsolicited AEs;Safety: SAEs;Safety: Adverse Events of Special Interest (AESI) | | | | Yes | False | | |
| +++ | NCT05113875 | 15 November 2021 | Health System Dynamic & Resource Requirement in a South African COVID-19 Field Hospital | Health System Dynamic & Resource Requirement in a South African COVID-19 Field | | University of Cape Town | 03/11/2021 | 20211103 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05113875 | Not recruiting | No | 18 Years | N/A | All | February 11, 2021 | 596 | Observational [Patient Registry] | | | South Africa | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - All patients admitted to the Mitchells Plain Hospital of Hope COVID-19 field hospital
<br> between 1st January 2021 and 29th February 2021. Patients admitted to the hospital
<br> must have been: over 18years of age, diagnosed with COVID-19 via polymerase chain
<br> reaction (PCR) test, transferred from a referring facility.
<br>
<br> Exclusion Criteria:
<br>
<br> - No patients were excluded.
<br> | | Field Hospitals;COVID-19 Pandemic;Health Systems;Global Health;Health Resources;Low-Income Population | | Patient Demographics;Patient Demographics;Patient Clinical Condition;Patient Clinical Condition;Patient Clinical Condition;Patient Clinical Condition;Patient Clinical Condition;Patient Clinical condition;Hospital Human Resources Utilized;Hospital Human Resources Utilized;Hospital Human Resources Utilized;Hospital Physical Resources Utilized;Hospital Physical Resources Utilized;Hospital Physical Resources Utilized;Hospital Physical Resources Utilized;Hospital Physical Resources Utilized;Hospital Physical resources Utilized;Health System Dynamics;Health System Dynamics;Health System Dynamics;Health System Dynamics;Health System Dynamics;Health System Dynamics;Health System Dynamics;Health System Dynamics;Local Incidence rates of COVID-19 infections;Local Incidence rates of COVID-19 infections | | | | Yes | False | | |
| +++ | NCT05114395 | 15 November 2021 | Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program | Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program: a Longitudinal Study in Pandemic Times | | Centro Hospitalar De São João, E.P.E. | 26/05/2021 | 20210526 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05114395 | Not recruiting | No | 18 Years | 65 Years | Female | March 8, 2021 | 39 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor). | N/A | Portugal | | Susana Moreira | | | | Centro Hospitalar Universitário São João |
<br> Inclusion Criteria:
<br>
<br> - Female patients aged between 18 and 65 years with SUI or MUI with a predominance of
<br> SUI with at least 1 urinary incontinence episode per week in the last month
<br>
<br> - Pelvic floor muscle strength greater than or equal to 2 (modified Oxford scale)
<br>
<br> - Capable of understanding and executing the therapeutic program and expressing
<br> agreement to participate in the study after free and informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients with urgency urinary incontinence or MUI with a predominance of urgency
<br>
<br> - Pregnant women
<br>
<br> - Submitted to conservative or surgical treatment of UI in the last 12 months
<br>
<br> - Active urinary tract infection
<br>
<br> - Macroscopic hematuria
<br>
<br> - Neurogenic dysfunction of the lower urinary tract
<br>
<br> - Cognitive deficit
<br>
<br> - Osteoarticular, neurological or psychiatric pathologies that prevent the realization
<br> of the therapeutic program
<br>
<br> - Active pelvic neoplasia
<br>
<br> - Pelvic organ prolapse grade greater than or equal to 2
<br>
<br> - Impossibility of access or illiteracy to technological means (phone or computer)
<br>
<br> - Unavailable to attend the face-to-face program due to accessibility, schedule,
<br> economic reasons or fear of the pandemic context
<br> | | Stress Urinary Incontinence;Incontinence, Urinary;Covid19;Pelvic Floor Muscle Weakness | Other: Pelvic Floor Telerehabilitation Program;Other: Pelvic Floor Face-to-Face Program | Assessment of urinary incontinence related quality of life using the Portuguese Version of the King's Health Questionnaire (KHQ). | | | | Yes | False | | |
| +++ | NCT05114967 | 15 November 2021 | Preoperative Anxiety During SARS-CoV-2 | Preoperative Anxiety Levels in Patients Undergoing Surgery During the 4th Wave of the SARS-CoV-2 Pandemic. A Prospective Observational Study | | University of Thessaly | 09/11/2021 | 20211109 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05114967 | Not recruiting | No | 18 Years | N/A | All | November 13, 2021 | 75 | Observational | | | Greece | ; ; | Eleni Arnaoutoglou, MD, PhD;Maria Ntalouka, MD, PhD, Msc;Eleni Arnaoutoglou, MD, PhD | | ;maria.ntalouka@icloud.com;earnaout@gmail.com | ;6973688099;2413501370 | University of Thessaly; |
<br> Inclusion Criteria:
<br>
<br> - Adult consecutive patients, >18 years old
<br>
<br> - Undergoing surgery in the UHL
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients aged<18 years
<br>
<br> - Patients that will refuse to participate
<br>
<br> - Patients unable/not fit to consent
<br> | | Anxiety;Pandemic, COVID-19 | Other: mPAS questionnaire | Anxiety level | | | | Yes | False | | |
| +++ | NCT05115019 | 15 November 2021 | A Clinical Trial to Evaluate the Efficacy of RUTI® to Reduce the Severity of SARS-CoV-2 Infection (COVID-19) | A Phase II/III, Double-blind, Randomized, Placebo-controlled Clinical Trial to Evaluate the Efficacy of RUTI® to Reduce the Severity of SARS-CoV-2 Infection | | RUTI Immunotherapeutics S.L. | 09/11/2021 | 20211109 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05115019 | Not recruiting | No | 18 Years | N/A | All | December 2021 | 550 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2/Phase 3 | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Sign the Informed Consent before initiating the selection procedures.
<br>
<br> 2. Patients infected with SARS-CoV-2 (PCR +) with mild symptoms up to 7 days that do not
<br> require hospitalization, from the onset of symptoms. Mild symptoms, defined as the
<br> following criteria: cough, headache, fever (>37.5ºC), muscular pain and shortness of
<br> breath.
<br>
<br> 3. People = 18 years.
<br>
<br> 4. Peripheral oxygen saturation (SpO2) more than 94% on room air, not requiring
<br> supplemental oxygen.
<br>
<br> 5. Availability to meet the requirements of the protocol.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnancy or breastfeeding.
<br>
<br> 2. Suspected of active viral or bacterial infection other than SARS-CoV-2.
<br>
<br> 3. Participation in another interventional study with potentially conflicting medication
<br> within 30 days before screening.
<br>
<br> 4. Severely immunocompromised people (data gathered from preexisting medical records and
<br> history taking). This exclusion category includes:
<br>
<br> 1. Subjects with human immunodeficiency virus (HIV-1).
<br>
<br> 2. Neutropenic subjects with less than 500 neutrophils / mm3.
<br>
<br> 3. Subjects with solid organ transplantation.
<br>
<br> 4. Subjects with bone marrow transplantation.
<br>
<br> 5. Subjects undergoing chemotherapy.
<br>
<br> 6. Subjects with primary immunodeficiency.
<br>
<br> 7. Severe lymphopenia with less than 400 lymphocytes / mm3.
<br>
<br> 8. Treatment with any anti-cytokine therapy.
<br>
<br> 9. Oral treatment with steroids, defined as daily doses of 10 mg prednisone or
<br> equivalent for more than 3 months.
<br>
<br> 5. Malignancy, or active solid or non-solid lymphoma from the previous two years.
<br>
<br> 6. BCG vaccination in the last 10 years.
<br>
<br> 7. Chloroquine or hydroxychloroquine administration in the last two weeks
<br>
<br> 8. Soy allergy
<br>
<br> 9. Direct involvement in the design or execution of the MYCOVIND clinical trial.
<br>
<br> 10. Do not have a smartphone.
<br>
<br> 11. Detection by the investigator of lack of knowledge or willingness to participate and
<br> comply with all requirements of the protocol.
<br>
<br> 12. Any other findings that, at the discretion of the investigator, may compromise
<br> compliance with the protocol or that may influence significantly the interpretation or
<br> the results of the effects of probiotics.
<br> | | COVID-19 | Biological: RUTI® vaccine;Biological: Placebo | Reduction patient rate to category 0 according to the WHO Ordinal scale by Day 30 after the initiation of vaccination | | | | Yes | False | | |
| +++ | NCT05115045 | 15 November 2021 | Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients | Plasma SARS-CoV-2 RNA Levels in Critically Ill COVID-19 Patients (pRNA-COVID-ICU) | pRNA-COVID-ICU | Hopital of Melun | 09/11/2021 | 20211109 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05115045 | Not recruiting | No | 18 Years | N/A | All | November 9, 2021 | 125 | Observational | | | | ; | SEBASTIEN JOCHMANS;Sébastien Jochmans, M.D. | | ;sebastien.jochmans@ghsif.fr | ;+33181742078 | GHSIF MELUN; |
<br> Inclusion Criteria:
<br>
<br> - age above 18 years
<br>
<br> - in ICU hospitalization
<br>
<br> - COVID-19 related pneumonia confirmed by PCR
<br>
<br> Exclusion Criteria:
<br>
<br> - plasmatic SARS-COV-2 RNA quantification not available
<br>
<br> - patient's refusal to participate
<br> | | COVID-19 Pneumonia;ARDS Due to Disease Caused by Severe Acute Respiratory Syndrome Coronavirus 2 | Diagnostic Test: plasmatic SARS-CoV-2 RNA quantification | Day 60 mortality | | | | Yes | False | | |
| +++ | NCT05115071 | 15 November 2021 | Online Childbirth Preparation Education in Covid-19 Pandemic | The Effect of Online Childbirth Preparation Education in Pregnancy on Worries and Fear of Birth, Preparation for Birth, and Well-being of Self and Baby in the Covid 19 Pandemic | | Pamukkale University | 06/11/2021 | 20211106 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05115071 | Not recruiting | No | 18 Years | N/A | Female | November 8, 2021 | 36 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Participant). | N/A | | | Okan Vardar, MSc, RN | | ovardar@pau.edu.tr | +905544493887 | |
<br> Inclusion Criteria:
<br>
<br> - Be over 18 years old
<br>
<br> - Volunteering to participate in research
<br>
<br> - Be at 24-34 weeks of gestation
<br>
<br> - Be nulliparous
<br>
<br> - Not having a high risk pregnancy
<br>
<br> - Be able to read and write Turkish
<br>
<br> - Be able to fill out an online survey form
<br>
<br> - Planning to have a normal spontaneous vaginal delivery
<br>
<br> Exclusion Criteria:
<br>
<br> - Be under the age of 18
<br>
<br> - Not completing eight hours of childbirth preparation education
<br>
<br> - Having a mental disorder that prevents answering survey questions
<br>
<br> - Having a psychiatric illness
<br>
<br> - Be able not use Microsoft Teams app
<br> | | Birth, First;COVID-19;Fear of Childbirth | Behavioral: Childbirth preparation education | Oxford Worries on Labour Scale (OWLS);Prenatal Self Evaluation Questionnaire (PSEQ)-Preparation for labor subscale;Prenatal Self Evaluation Questionnaire (PSEQ)-Well-being of self and baby subscale;Fear of Birth Scale (FOBS);The Fear of COVID-19 Scale (FCV-19S) | | | | Yes | False | | |
| +++ | NCT05115084 | 15 November 2021 | The Effect of the COVID-19 Epidemic Process on the Nutritional Habits and Body Weights of Adults | The Effect of the COVID-19 Epidemic Process on the Nutritional Habits and Body Weights of Adults | | Istanbul Medeniyet University | 06/11/2021 | 20211106 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05115084 | Not recruiting | No | 19 Years | 70 Years | All | December 3, 2021 | 160 | Observational | | | | | | | | | |
<br> Inclusion Criteria: Adult individuals wishing to participate in the study -
<br>
<br> Exclusion Criteria: Individuals outside the age range of 19-70 years, all individuals who
<br> did not agree to participate in the study.
<br>
<br> -
<br> | | COVID-19 Pandemic;Eating Habit;Weight Gain | Other: no intervention | Questionnaire | | | | Yes | False | | |
| +++ | NCT05115097 | 15 November 2021 | AI Evaluation of COVID-19 Sounds (AI-EChOS) | AI Evaluation of COVID-19 Sounds | AI-EChOS | IRCCS San Raffaele | 09/11/2021 | 20211109 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05115097 | Recruiting | No | 18 Years | N/A | All | September 20, 2021 | 100 | Observational | | | Italy | ; | Marco Montagna, Medicine;Marco Montagna, Medicine | | ;montagna.marco@hsr.it | ;+390226439744 | Vita-Salute San Raffaele University; |
<br> Inclusion Criteria:
<br>
<br> - Adults who tested positive for SARS-CoV-2
<br>
<br> - Currently admitted to hospital at the study site
<br>
<br> Exclusion Criteria:
<br>
<br> - Patients under the age of 18.
<br>
<br> - Patients unable to read in Italian.
<br>
<br> - Patients unable to give informed consent to participate.
<br>
<br> - Patients requiring life support (including, but not limited to, mechanical cardiac
<br> support, ventilation, etc.)
<br>
<br> - Patients who are pregnant
<br> | | COVID-19;COVID-19 Respiratory Infection;Cough;Breathing Sound;Breathing, Mouth | | Accuracy evaluation | | | | Yes | False | | |
| +++ | NCT05115162 | 15 November 2021 | The Effects of the Hybrid Telerehabilitation Exercise in Inactive Students | The Effects of the Hybrid Telerehabilitation Exercise Program in Inactive University Students During Covid-19 Pandemic - A Randomized Controlled Study | | Marmara University | 01/11/2021 | 20211101 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05115162 | Not recruiting | No | 18 Years | 30 Years | All | December 1, 2020 | 63 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant). | N/A | Turkey | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - ....>18 years old
<br>
<br> - Pittsburg Sleep Quality Index total score >5 points
<br>
<br> - No history of orthopedic, neurological, or cardiovascular disease
<br>
<br> - Physical activity level < 600 MET-min-week according to International Physical
<br> Activity Questionnaire-Short From.
<br>
<br> - Cooperative
<br>
<br> - Not exposed to any telerehabilitation application
<br>
<br> Exclusion Criteria:
<br>
<br> - Having cancer, diabetes mellitus, pregnancy, infection, rheumatic pain
<br>
<br> - Less than 85% attendance to the program
<br>
<br> - Participating in any other physical activity program
<br> | | Physical Activity;Exercise | Other: Exercise | Pittsburgh Sleep Quality Index (PSQI):;Pittsburgh Sleep Quality Index | | | | No | False | | |
| +++ | NCT05115435 | 15 November 2021 | The Effect of Neuro Linguistic Programming on COVID-19 Fear in Kidney Transplant | The Effect of Neuro Linguistic Programming on COVID-19 Fear in Kidney Transplant | | Inonu University | 08/11/2021 | 20211108 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05115435 | Not recruiting | No | 18 Years | N/A | All | March 1, 2021 | 74 | Interventional | Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Supportive Care. Masking: Single (Participant). | N/A | Turkey | | | | | | |
<br> Inclusion Criteria:Patients who could communicate verbally, had no hearing problems, had a
<br> high or moderate fear of Covid-19 (20 or more), and had not applied NLP before were
<br> included in the study.
<br>
<br> -
<br>
<br> Exclusion Criteria: Patients who wanted to leave voluntarily at any stage after being
<br> included in the study, and who had to be hospitalized again for organ rejection or any
<br> other reason while the study was ongoing, were excluded from the study.
<br>
<br> -
<br> | | Kidney Transplant Patients | Behavioral: neuro linguistic programming | A mean total score on the | | | | Yes | False | | |
| +++ | NCT05115526 | 15 November 2021 | PEEP Setting in COVID19-related ARDS | Positive End-expiratory Pressure Setting in COVID-19 Related ARDS : Comparison Between Electrical Impedance Tomography, PEEP/ Fraction of Inspired Oxygen Tables, and Transpulmonary Pressure. | | Central Hospital, Nancy, France | 15/10/2021 | 20211015 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05115526 | Not recruiting | No | 18 Years | 80 Years | All | March 1, 2021 | 17 | Observational | | | France | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - COVID19-related ARDS under invasive mechanical ventilation
<br>
<br> Exclusion Criteria:
<br>
<br> - none
<br> | | ARDS Due to Severe Acute Respiratory Syndrome Coronavirus 2 | Other: PEEP setting | Value of PEEP | | | | Yes | False | | |
| +++ | NCT05115617 | 15 November 2021 | Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination Prospective Cohort Study | Pregnant and Lactating Individuals & Newborns COVID-19 Vaccination (PLAN-V): Prospective Cohort Study | PLAN-V | Ottawa Hospital Research Institute | 28/09/2021 | 20210928 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05115617 | Recruiting | No | N/A | N/A | Female | June 3, 2021 | 150 | Observational | | | Canada | ; | Darine El-Chaâr, MD, MSc;Stephanie Boyd, MBA | | ;sboyd@ohri.ca | ;613-737-8899 | The Ottawa Hospital; |
<br> Inclusion Criteria:
<br>
<br> - Women/Individuals = 16 years of age who are =7 0/7 weeks' gestation on the day of
<br> enrollment
<br>
<br> - Capacity to provide informed consent and to comprehend and comply with the study
<br> requirements
<br>
<br> - Planning to deliver at a participating site hospital
<br>
<br> - Planning to receive or have previously received one-dose of a Health Canada approved
<br> COVID-19 vaccine (any product, any number of doses) during the current pregnancy
<br>
<br> Exclusion Criteria:
<br>
<br> - Cases with known major fetal concerns
<br>
<br> - Women/Individuals who are fully vaccinated against COVID-19
<br>
<br> - Women/Individuals who are pregnant due to surrogacy, or planning to give their child
<br> up for adoption
<br>
<br> - Women/Individuals with a non-viable pregnancy (e.g., ectopic)
<br> | | SARS-CoV2 Infection;Covid19;Vaccine Reaction;Pregnancy Related;Immunogenicity | | Antibody titres in biological samples;Antibody titres in biological samples;Antibody titres in biological samples;Antibody titres in biological samples;Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.;Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.;Antibody titres in biological samples of participants who received COVID-19 vaccine and who had natural COVID-19 disease.;Antibody titres in biological samples of pregnant and non-pregnant populations | | | | Yes | False | | |
| +++ | NCT05116657 | 15 November 2021 | Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome | Obstructive Sleep Apnoea Post Covid 19: Role of the Upper Airway Microbiome | | Royal College of Surgeons, Ireland | 10/11/2021 | 20211110 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05116657 | Not recruiting | No | 18 Years | N/A | All | November 22, 2021 | 50 | Observational | | | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Symptoms of sleepiness, fatigue, loud snoring
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Gross skeletal alterations affecting the upper airway (eg.micrognathia)
<br>
<br> 2. Unstable chronic medical conditions known to affect OSA (CHF, stroke) 3.
<br>
<br> 3. Pregnancy or intent to become pregnant within the period of the protocol
<br>
<br> 4. Inability to sign informed consent form
<br>
<br> 5. Habitual snorer or previous diagnosis of OSA.
<br>
<br> 6. Less than 18 years of age.
<br> | | Sleepiness;SARS-CoV2 Infection;Fatigue Syndrome, Chronic;Snoring | Diagnostic Test: Nasal Lavage and Oral Wash | Examine the incidence of post SARS-CoV-2 infection obstructive sleep apnoea (OSA) and its relationships with the upper airway/nasal microenvironment | | | | Yes | False | | |
| +++ | NCT05116748 | 15 November 2021 | COVID19 Vaccine in SOT Adult Recipients | Safety and Immunogenicity of the SARS-CoV2 Vaccine in Solid Organ Transplantation (Lung and / or Liver) Adult Recipients | COVID19_VaxSOT | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | 28/09/2021 | 20210928 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05116748 | Recruiting | No | 18 Years | N/A | All | October 1, 2021 | 200 | Observational | | | Italy | ; ; | Letizia Corinna Morlacchi, MD;Letizia Corinna Morlacchi, MD;Letizia Corinna Morlacchi, MD | | ;letizia.morlacchi@policlinico.mi.it;letizia.morlacchi@policlinico.mi.it | ;00393338158766;00393338158766 | Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico di Milano; |
<br> Inclusion Criteria:
<br>
<br> - Age > 18 years
<br>
<br> - Patient's written informed consent
<br>
<br> Exclusion Criteria:
<br>
<br> - Lung transplant being performed in the previous 6 months
<br>
<br> - Liver transplant being performed in the previous 3 months
<br> | | COVID-19;Vaccine Adverse Reaction;Vaccine Response Impaired;Vaccine Reaction;Lung Transplant; Complications;Liver Transplant; Complications;Vaccination | Biological: COVID19 mRNA vaccine | Safety and reactogenicity | | | | Yes | False | | |
| +++ | NCT05116761 | 15 November 2021 | ExoFlo™ Infusion for Post-Acute COVID-19 and Chronic Post-COVID-19 Syndrome | Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles Infusion Treatment for Post-Acute and Chronic Post-COVID-19 Syndrome: A Phase I/II Clinical Trial | | Direct Biologics, LLC | 09/11/2021 | 20211109 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05116761 | Not recruiting | No | 18 Years | 85 Years | All | December 2021 | 60 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 1/Phase 2 | | ; | Vikram Sengupta, MD;Heidi Moran | | ;hmoran@directbiologics.com | ;800-791-1021 | Direct Biologics; |
<br> Inclusion Criteria:
<br>
<br> 1. Provision of signed and dated informed consent form (either by the individual or by
<br> the individual's healthcare proxy).
<br>
<br> 2. Stated willingness to comply with all study procedures and availability for the
<br> duration of the study
<br>
<br> 3. Male or female aged 18-85.
<br>
<br> 4. Discharged from recent hospitalization for severe COVID-19 disease requiring
<br> supplemental oxygen but not requiring mechanical ventilation or ECMO or dialysis.
<br>
<br> 5. Must be between 4 to 20 weeks since onset of acute COVID-19 symptoms onset.
<br>
<br> 6. No return to baseline health or hiatus between acute COVID-19 and onset of post-acute
<br> COVID-19 or chronic post-COVID-19 syndrome.
<br>
<br> 7. Current SARS-CoV-2 RT PCR must be negative prior to enrollment.
<br>
<br> 8. At least 2 or more persistent symptoms frequently reported for post-acute COVID-19 or
<br> chronic post-COVID-19 syndrome such as fatigue, cough, headache, body aches, fever,
<br> chills, loss of taste, loss of smell, diarrhea, congestion, dyspnea, sore throat,
<br> chest pain, abdominal pain, confusion, or vomiting must be moderate in severity based
<br> on modified CDC Symptoms Questionnaire (See Section 11.1 for severity scoring system).
<br>
<br> 9. Medical Resource Council Dyspnea Score of < 3 out of 5.
<br>
<br> 10. Baseline EQ-5D-5L must be higher than 21211. (Of note: EQ-5D-5L has 5 dimensions:
<br> mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each
<br> dimension is scored from 1 (full) to 5 (worst), such that a score of 11111 is
<br> reflective of full quality-of-life and a score of 55555 is reflective of worst
<br> quality-of-life.)
<br>
<br> 11. Baseline 6-Minute Walk Test (6-MWT) is 500 meters or less.
<br>
<br> 12. Supplemental oxygen should be =5 L O2/min.
<br>
<br> 13. If the candidate is either male or female of reproductive potential, he or she must
<br> agree to use of double barrier method of highly effective birth control contraception
<br> such as condoms with oral contraceptive pill or choose to remain abstinent if already
<br> practicing abstinence during the screening period. The duration of required usage of
<br> double barrier method OR maintenance of abstinence must include the time from the
<br> beginning of the screening period until 90 days following the last dose of the study
<br> treatment.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Vulnerable populations such as pregnant patients, children, individuals with severe
<br> physical or mental disabilities who cannot provide meaningful consent.
<br>
<br> 2. Active malignancy requiring treatment within the last five years.
<br>
<br> 3. Major physical trauma in the last 3 months, including motor vehicle accidents,
<br> assaults, mechanical falls with sequelae of significant bleeding or craniofacial
<br> bruising, and surgeries.
<br>
<br> 4. Patients with persistent symptoms due to any of the following chronic comorbidities
<br> such as active tuberculosis or cystic fibrosis, chronic respiratory disease including
<br> chronic obstructive pulmonary disease or pulmonary fibrosis requiring baseline home
<br> oxygen > 5 L O2/min, history of unstable angina or a heart attack during the last 12
<br> months, pulmonary hypertension, hepatic impairment, chronic kidney disease,
<br> uncontrolled diabetes, substance abuse, severe osteoarthritis, HIV, migraine disorder,
<br> fibromyalgia, dementia, connective tissue disorders, and endocrine disorders.
<br>
<br> 5. Depression as screened by positive Patient Health Questionnaire (PHQ2) and confirmed
<br> as moderate or higher severity on PHQ9 (See Appendix 11.5). Of note, subjects found to
<br> have moderate or higher on PHQ-9 will be referred for appropriate outpatient
<br> psychiatric evaluation and intervention for their depression.
<br>
<br> 6. Vital sign abnormalities: temperature = 38 °C, temperature < 35 °C; systolic blood
<br> pressure (SBP) < 90 mmHg, SBP = 170 mmHg; diastolic blood pressure (DBP) < 50 mmHg,
<br> DBP = 100 mmHg; heart rate (HR) < 50 beats per minute (BPM), HR = 120 BPM.
<br>
<br> 7. Lab abnormalities: WBC = 12,000 /µL, Creatinine = 1.5 mg/dL, AST = 100 IU/l, and/or
<br> ALT = 100 IU/I
<br>
<br> 8. Patients who require rolling walker or wheelchair or higher level of assistance for
<br> ambulation.
<br> | | Covid19;Postviral Syndrome;Dyspnea | Biological: Bone Marrow Mesenchymal Stem Cell Derived Extracellular Vesicles;Other: Saline | Increased distance on Six Minute Walk Test (6MWT);Incidence of Serious Adverse Events (SAEs) | | | | Yes | False | | |
| +++ | NCT05116865 | 15 November 2021 | A Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled HH-120 Aerosol in Healthy Volunteers | A Double-Blinded, Randomized, and Placebo-Controlled Phase 1 Study to Assess the Safety, Tolerability and Pharmacokinetics Profile of Single and Multiple Ascending Doses of Inhaled HH-120 Aerosol in Healthy Volunteers | | Huahui Health | 19/10/2021 | 20211019 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05116865 | Not recruiting | No | 18 Years | 65 Years | All | November 2021 | 48 | Interventional | Allocation: Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator). | Phase 1 | Australia | ; ; | Yongqing Lin;Qingping Chu;Paul Griffin | | ;chuqingping@hhhbio.com;p.griffin@nucleusnetwork.com.au | ;+86.13810180939;(07) 3707 2720 | Huahui Health Ltd; |
<br> Inclusion Criteria:
<br>
<br> 1. Healthy male or female volunteers aged 18 to 65 years (both inclusive)
<br>
<br> 2. Participants must have a body mass index between = 18.0 and = 32 .0 kg/m2 and a
<br> bodyweight of at least 45 kg at Screening.
<br>
<br> 3. Participants must be a non-smoker and must not have used any tobacco products within
<br> 90 days prior to Screening.
<br>
<br> 4. Participants must be in good general health, with no significant medical history, have
<br> no clinically significant abnormalities on physical examination at screening and/or
<br> before administration of the initial dose of IP.
<br>
<br> 5. Participants must have clinical laboratory values within normal range.
<br>
<br> 6. Females must be non-pregnant and non-lactating, and must use an acceptable, highly
<br> effective double contraception from Screening until study completion, including the
<br> follow-up period.
<br>
<br> 7. Males must not donate sperm for at least 90 days after the last dose of IP.
<br>
<br> 8. Participants must have the ability and willingness to attend the necessary visits to
<br> the CRU.
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Pregnant or lactating at Screening or planning to become pregnant (self or partner) at
<br> any time during the study, including the follow-up period.
<br>
<br> 2. Prior or ongoing medical conditions, medical history, physical findings, or laboratory
<br> abnormality that, in the PI's (or delegate's) opinion, could adversely affect the
<br> safety of the participant or that might interfere with the conduct of the study.
<br>
<br> 3. Presence of any underlying physical or psychological medical condition
<br>
<br> 4. Pre-existing severe obstructive disease of the respiratory system such as chronic
<br> obstructive pulmonary disease or asthma , including resolved childhood asthma, which
<br> may impact inhalation as judged by the PI, delegate, or Sponsor.
<br>
<br> 5. History or evidence o f any anatomical airway defect, which in the opinion of the PI,
<br> may impact inhalation.
<br>
<br> 6. Abnormal spirometry findings at Screening that are considered by the PI to be
<br> clinically significant, including FEV1 < 80% or FVC < 80%.
<br>
<br> 7. Blood donation of > 500 mL or significant blood loss within 60 days prior to the first
<br> IP administration or plasma donation within 7 days prior to IP administration.
<br>
<br> 8. Systemic or respiratory infection within 2 weeks before the Screening visit or fever
<br> (tympanic temperature > 37.5°C) or symptomatic viral or bacterial infection at time of
<br> Screening.
<br>
<br> 9. Current infection with SARS-CoV-2, infection within the 2 weeks prior to Screening, or
<br> a history of SARS-CoV-2 infection plus symptoms of post-COVID syndrome.
<br>
<br> 10. History of anaphylaxis or other significant allergy in the opinion of the PI or known
<br> allergy or hypersensitivity to any of the components of the IP.
<br>
<br> 11. History of malignancy, except for non-melanoma skin cancer, excised more than 2 years
<br> ago and cervical intraepithelial neoplasia that has been successfully cured more than
<br> 5 years prior to Screening.
<br>
<br> 12. A personal history of unexplained blackouts or fainting or known risk factors for
<br> Torsade de Pointes (eg, hypokalemia, heart failure).
<br>
<br> 13. Abnormal 12-lead ECG findings at Screening that are considered by the PI to be
<br> clinically significant, including arrhythmias or marked QT interval abnormalities
<br> (QTcF < 300 msec or = 450 msec at Screening).
<br>
<br> 14. Confirmed (eg, 2 consecutive triplicate measurements) average systolic blood pressure
<br> (SBP) > 140 or < 90 mmHg, and diastolic blood pressure (DBP) > 90 or < 45 mmHg at
<br> Screening.
<br>
<br> 15. Confirmed (eg, 2 consecutive triplicate measurements) average resting HR > 100 or < 45
<br> beats per minute at Screening.
<br>
<br> 16. Vaccination with a live vaccine within the 4 weeks prior to Screening or that is
<br> planned within 4 weeks of dosing, and any non-live vaccination within the 2 weeks
<br> prior to Screening, or that is planned within 2 weeks of dosing or planned during
<br> study participation (including vaccines for COVID-19).
<br>
<br> 17. Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or
<br> human immunodeficiency virus (HIV) antibody at Screening.
<br>
<br> 18. Participants with a positive toxicology screening panel (urine test including
<br> qualitative identification of barbiturates, tetrahydrocannabinol [THC], amphetamines,
<br> benzodiazepines, opiates, cocaine, and cotinine), or alcohol breath test at Screening
<br> or Day -1.
<br>
<br> 19. Participants with a history of substance abuse or dependency or history of
<br> recreational intravenous (IV) drug use over the last 6 months (by self-declaration).
<br>
<br> 20. Use of any IP or medical device within 30 days prior to screening.
<br>
<br> 21. Use of any prescription drugs for 14 days prior to dosing or over the counter
<br> medication, herbal remedies, supplements or vitamins 7 days prior to dosing.
<br> | | COVID-19 Respiratory Infection | Biological: HH-120 Dose 1;Biological: HH-120 Dose 2;Biological: HH-120 Dose 3;Drug: Placebo | Number of participants with treatment emergent adverse events (TEAEs);Severity of treatment emergent adverse events (TEAEs)as assessed by CTCAE v5.0;Duration of treatment emergent adverse events (TEAEs);Number of participants with serious adverse events (SAEs);Severity of serious adverse events (SAEs) as assessed by CTCAE v5.0;Duration of serious adverse events (SAEs);Number of participants with abnormal clinically significant physical examination findings;Number of participants with abnormal clinically significant electrocardiogram (ECG);Number of participants with clinically significant change in vital signs from baseline;Changes in the spirometry score from Baseline;Number of participants with abnormal clinically significant clinical laboratory parameters | | | | Yes | False | | |
| +++ | NCT05118373 | 15 November 2021 | Generic Behavioural Change Campaign for COVID-19 Prevention | Evaluation of a Generic Behavioural Change Campaign for COVID-19 Prevention in Zambia | | Centre for Infectious Disease Research in Zambia | 18/08/2021 | 20210818 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05118373 | Not recruiting | No | 18 Years | N/A | All | August 18, 2021 | 2004 | Interventional | Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Other. Masking: None (Open Label). | N/A | Zambia | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - Must be 18years and above
<br>
<br> - Must reside in Lusaka, Copperbelt, Southern or Eastern Province
<br>
<br> - Volunteer to take part in the study
<br>
<br> Exclusion Criteria:
<br>
<br> - Participants not from Lusaka, Copperbelt, Southern or Eastern Province
<br> | | Evaluation Study | Behavioral: BEHAVIOURAL CHANGE CAMPAIGN FOR COVID-19 PREVENTION IN ZAMBIA | Behaviour Change | | | | Yes | False | | |
| +++ | NCT05118711 | 15 November 2021 | Sequelae of COVID-19 With Focus on Exercise Capacity and Underlying Mechanisms | COVID-19 Severity, Long-term Consequences for Exercise Capacity and Link to Associated Mechanisms | COR-PHYS | Arno Schmidt-Trucksäss | 08/11/2021 | 20211108 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05118711 | Not recruiting | No | 40 Years | N/A | All | January 2022 | 450 | Observational | | | Switzerland | ; | Arno Schmidt-Trucksäss, Prof.;Arno Schmidt-Trucksäss, Prof. | | ;arno.schmidt-trucksaess@unibas.ch | ;+41 61 207 47 40 | Department of Sport, Exercise and Health, University of Basel, Basel, Switzerland; |
<br> Inclusion Criteria:
<br>
<br> - tested positive for SARS-nCOV-2 using antigen- or PCR tests within the last 24 months
<br>
<br> - previous hospitalization due to COVID-19
<br>
<br> - fully vaccinated (only for controls)
<br>
<br> Exclusion Criteria:
<br>
<br> - inability to follow the study procedures (e.g. due to language barriers, psychological
<br> disorders, dementia, etc.),
<br>
<br> - known pregnancy or lactating women,
<br>
<br> - presence of any contraindications for exercising until maximum exhaustion, including
<br> insufficient blood pressure control (systolic >170 mmHg, diastolic >100 mmHg), ongoing
<br> cancer treatment, unstable angina pectoris, uncontrolled bradyarrhythmia or
<br> tachyarrhythmia, severe uncorrected valvular heart disease, clinically relevant acute
<br> infection, any form of musculoskeletal injury,
<br>
<br> - participating in any interventional clinical trial within the last four weeks,
<br>
<br> - previous participation in the current study
<br>
<br> - history of COVID-19 (only for controls)
<br> | | Moderate COVID-19;Severe COVID-19;Controls | Diagnostic Test: Cardiorespiratory fitness;Diagnostic Test: Lung function;Diagnostic Test: Muscular strength and balance tests;Diagnostic Test: Micro- and macrovascular endothelial function and cardiac function;Diagnostic Test: Blood sampling and analysis;Diagnostic Test: Physical activity;Diagnostic Test: Questionnaires;Diagnostic Test: Body composition | Cardiorespiratory fitness (as % of predicted V?O2max) | | | | Yes | False | | |
| +++ | NCT05118737 | 15 November 2021 | Adding Colchicine to Tocilizumab in Patients With Severe COVID-19 Pneumonia. | Adding Colchicine to Tocilizumab in Hospitalized Patients With Severe COVID-19 Pneumonia: An Open-Label Randomized Controlled Trial | | Hamad Medical Corporation | 11/11/2021 | 20211111 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05118737 | Recruiting | No | 18 Years | 90 Years | All | October 1, 2021 | 230 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | Early Phase 1 | Qatar | ; ; | Alaa Rahhal, Msc;Alaa Rahhal, Msc;Ala Rahal, MSC pharm | | ;arahhal1@hamad.qa;ARahhal1@hamad.qa | ;+97455712353;00974395897 | Hamad Medical Corporation; |
<br> Inclusion Criteria:
<br>
<br> - - Alert and conscious adults with the age of > 18 years old Severe COVID-19 pneumonia
<br>
<br> o SpO2 <94% on room air at sea level, respiratory frequency >30 breaths/min, or lung
<br> infiltrates >50%
<br>
<br> - Received tocilizumab within 10 days prior to enrollment
<br>
<br> - Tocilizumab is co-admisnitered with a systemic corticosteroid
<br>
<br> - Agree to sign conflict of interest
<br>
<br> Exclusion Criteria:
<br>
<br> - - Severe COVID-19 pneumonia requiring invasive mechanical ventilation
<br>
<br> - Creatinine clearance < 30 mL/min
<br>
<br> - End stage renal disease on hemodialysis
<br>
<br> - ALT and/or AST > 5 upper limit of normal
<br>
<br> - Pregnancy
<br>
<br> - Lactation
<br>
<br> - To prevent colchicine toxicity, patients receiving a strong CYP3A4 inhibitor (eg
<br> clarithromycin, indinavir, itraconazole, ketoconazole, nefazodone, nelfinavir,
<br> ritonavir, saquinavir, telithromycin, atazanavir), a moderate CYP3A4 inhibitor (eg
<br> diltiazem, verapamil, fluconazole, amprenavir, aprepitant, fosamprenavir) or a P-gp
<br> Inhibitor (eg cyclosporine, ranolazine), will be excluded
<br> | | COVID-19 Pneumonia | Drug: Colchicine | Rate of invasive mechanical ventilation | | | | Yes | False | | |
| +++ | NCT05118763 | 15 November 2021 | Intranasal INNA-051 for Prevention of COVID-19 in Adults | A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety, Tolerability, and Efficacy of Intranasal INNA-051 for Prevention of COVID-19 in Adults Following Close Contact With Individuals With SARS-CoV-2 Infection | | ENA Respiratory Pty Ltd | 27/10/2021 | 20211027 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05118763 | Not recruiting | No | 18 Years | N/A | All | March 1, 2022 | 423 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor). | Phase 2 | | | | | | | |
<br> Inclusion Criteria:
<br>
<br> 1. Capable of understanding the written informed consent, provides signed written
<br> informed consent, and agrees to comply with protocol requirements.
<br>
<br> 2. Male or female aged =18 years.
<br>
<br> 3. Must have a symptomatic household contact ("index case") with rapid antigen/point
<br> of-care or RT-PCR-confirmed SARS-CoV-2 infection and onset of symptoms in the
<br> household contact within 5 days prior to screening.
<br>
<br> 4. Participants of non-childbearing potential. Non-childbearing potential is defined as
<br> surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy,
<br> hysterectomy, or vasectomy) or postmenopausal (amenorrhea for at least 12 months prior
<br> to screening without an alternative medical cause).
<br>
<br> Exclusion Criteria:
<br>
<br> 1. Prior exposure to INNA-051.
<br>
<br> 2. Previous receipt of any full primary series SARS-CoV-2 vaccine or receipt of a booster
<br> vaccination following a full primary series within 12 months of screening.
<br>
<br> 3. Any symptoms of COVID-19 within 72 hours prior to screening. Symptoms may include
<br> fever (=38°C), cough, sore throat, malaise, headache, muscle pain, nausea, vomiting,
<br> diarrhea, loss of taste and/or smell, shortness of breath, or difficulty breathing.
<br>
<br> 4. History of RT-PCR-confirmed SARS-CoV-2 infection within 6 months prior to screening.
<br>
<br> 5. Positive point-of-care rapid SARS-CoV-2 diagnostic test at the time of screening.
<br>
<br> 6. Body mass index =35 kg/m2.
<br>
<br> 7. History of human immunodeficiency virus, current chronic hepatitis B virus or
<br> hepatitis C virus infection or current tuberculosis.
<br>
<br> 8. History of chronic kidney disease (Stage 3 or higher).
<br>
<br> 9. Chronic lung disease (chronic obstructive pulmonary disease, moderate-to-severe poorly
<br> controlled asthma [as evident within the last month of awakening with asthma symptoms
<br> 1 or more times/week or use of short-acting beta-agonists 3 or more times/week],
<br> interstitial lung disease, cystic fibrosis, pulmonary hypertension).
<br>
<br> 10. History of significant cardiovascular disease (e.g., congestive heart failure,
<br> cardiomyopathy, ischemic heart disease) or history of myocarditis or pericarditis.
<br>
<br> 11. Current uncontrolled hypertension defined as average of 3 systolic blood pressure
<br> readings of =140 mmHg or an average of 3 diastolic blood pressure =90 mmHg.
<br>
<br> 12. History of chronic liver disease or documented evidence of liver fibrosis or
<br> cirrhosis.
<br>
<br> 13. History of hemoglobinopathy (sickle cell disease, thalassemia).
<br>
<br> 14. Chronic use of inhaled substances including tobacco, nicotine vapor, or cannabis
<br> (average of =5 cigarettes a day for =1 month within 1 year of screening or a 10 pack
<br> year history or equivalent).
<br>
<br> 15. History of neurological or neurodevelopmental conditions (e.g., Down's syndrome,
<br> dementia, migraine, epilepsy, stroke, seizure in the last 3 years, encephalopathy,
<br> focal neurologic deficits, Guillain-Barré syndrome, encephalomyelitis, or transverse
<br> myelitis).
<br>
<br> 16. History of malignancy in the last 5 years, except for adequately treated basal cell or
<br> squamous cell skin cancer or in situ cervical cancer.
<br>
<br> 17. History of immunodeficiency or chronic use (more than 14 continuous days) of any
<br> medication that may be associated with changes in the immune function including, but
<br> not limited to, systemic corticosteroids exceeding 10 mg/day of prednisone equivalent,
<br> allergy injections, immunoglobulin, interferon, immunomodulators, cytotoxic drugs, or
<br> other similar or toxic drugs within 6 months of screening. Note: The use of low-dose
<br> topical and ophthalmic steroid preparations is permitted.
<br>
<br> 18. Use of nasal sprays (including but not limited to nasal glucocorticoids), intranasal
<br> washes, or other intranasal applications within 7 days prior to screening, or planned
<br> use during the study period.
<br>
<br> 19. Known allergy or sensitivity or contraindication to study drug or its excipients.
<br>
<br> 20. Treatment with any other investigational therapy or device within 30 days or within 5
<br> half-lives, whichever is longer, prior to screening.
<br>
<br> 21. Female participants who are pregnant or trying to become pregnant, or who are
<br> breastfeeding.
<br>
<br> 22. Known history of substance abuse that in the investigator's judgment would prevent
<br> participant from providing informed consent or being able to comply with study
<br> procedures.
<br>
<br> 23. Other severe, acute, or chronic medical or psychiatric condition(s) that may increase
<br> the risk associated with study participation or interfere with the participant's
<br> ability to comply with study procedures
<br> | | COVID-19 Pandemic | Drug: INNA-051;Other: Placebo | Evaluate the ability of INNA-051 to reduce the incidence of symptomatic RT-PCR confirmed SARS-CoV-2 infection;Evaluate the safety and tolerability of INNA 051. | | | | Yes | False | | |
| +++ | NCT05119348 | 15 November 2021 | Transmission of COVID19 in Crowded Environments | Transmission of COVID19 in Crowded Environments | TRACE | Desmond Tutu HIV Foundation | 12/11/2021 | 20211112 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05119348 | Not recruiting | No | 12 Years | N/A | All | September 14, 2020 | 114 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: Single (Investigator). | N/A | South Africa | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - recently diagnosed SARS-CoV-2 positive
<br>
<br> - Individual >12 years
<br>
<br> - Able to give assent if <18 years with parental/guardian consent
<br>
<br> - Able to give consent> 18 years
<br>
<br> - Self-isolating at home at the time of COVID diagnosis
<br>
<br> Exclusion Criteria:
<br>
<br> - <12 years
<br>
<br> - Unable to give consent
<br> | | Covid19 Testing;Sars-cov-2 Infection Antibody Testing;Sars-cov-2 Testing | Other: STOPCOV | SARS-CoV-2 infection | | | | No | False | | |
| +++ | NCT05119400 | 15 November 2021 | COVID-19 (Coronavirus Disease-2019) Psychiatric Outcomes | Psychiatric Outcomes Following Inpatient Hospitalization For COVID-19 | | Weill Medical College of Cornell University | 27/10/2021 | 20211027 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05119400 | Not recruiting | No | 18 Years | 89 Years | All | December 2021 | 60 | Observational | | | United States | ; ; | Abhishek Jaywant, PhD;Abhishek Jaywant, PhD;Abhishek Jaywant, PhD | | ;abj2006@med.cornell.edu;abj2006@med.cornell.edu | ;212-746-4666;212-746-4666 | Weill Medical College of Cornell University; |
<br> Inclusion Criteria-COVID-19 group:
<br>
<br> - Men and women age 18-89.
<br>
<br> - Past diagnosis of COVID-19 with confirmed positive SARS-CoV-2 PCR test in electronic
<br> medical record
<br>
<br> - English and/or Spanish speaking
<br>
<br> - Previously hospitalized at NYP/WCM between March 1 and December 31, 2020 for a minimum
<br> of three days.
<br>
<br> Inclusion Criteria-Comparison group:
<br>
<br> - Men and women age 18-89
<br>
<br> - English and/or Spanish speaking
<br>
<br> - Previously hospitalized at NYP/WCM between March 1 and December 31, 2020 for a minimum
<br> of three days.
<br>
<br> - Underwent hospitalization secondary to a medical diagnosis that was not COVID-19
<br>
<br> Exclusion Criteria--COVID-19 group:
<br>
<br> N/A
<br>
<br> Exclusion Criteria--Comparison group:
<br>
<br> - Past diagnosis of COVID-19
<br>
<br> - Admitted to inpatient hospitalization due to, or past history of, a primary central
<br> nervous system relation etiology such as stroke, brain tumor, encephalitis, traumatic
<br> brain injury, multiple sclerosis, or Parkinson's disease.
<br> | | Covid19;Anxiety;Mood;Cognitive Impairment | | Cognitive functioning as measured by Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) (English or Spanish) | | | | Yes | False | | |
| +++ | NCT05119465 | 15 November 2021 | COVID-19 Clinical Status Associated With Outcome Severity: An Unsupervised Machine Learning Approach | Does Corona Virus Disease (COVID)-19 Clinical Status Associates With Outcome Severity?An Unsupervised Machine Learning Approach for Knowledge Extraction | | Aristotle University Of Thessaloniki | 12/11/2021 | 20211112 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05119465 | Not recruiting | No | N/A | N/A | All | November 1, 2019 | 268 | Observational | | | Greece | | | | | | |
<br> Inclusion Criteria:
<br>
<br> - patients that came into emergency department and diagnosed with COVID-19 infection
<br>
<br> Exclusion Criteria:
<br>
<br> - none
<br> | | COVID-19 | | Cluster of patients depending on severity of infection | | | | No | False | | |
| +++ | NCT05119530 | 15 November 2021 | POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test | U.S. POC Study to Evaluate the Performance of the AcuVid COVID-19 Rapid Antigen Saliva Test | | Therma Bright Inc | 11/11/2021 | 20211111 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05119530 | Not recruiting | No | 12 Years | N/A | All | November 2021 | 300 | Observational | | | | | Hazel Flores | | hazel@covidclinic.org | 909-462-4161 | |
<br> Inclusion Criteria:
<br>
<br> - Participant is willing to sign verbal informed consent form.
<br>
<br> - Age =12 and parents or legal guardians must consent as required by law.
<br>
<br> - Participant is attending COVID-19 testing centre to provide a nasopharyngeal swab
<br> sample.
<br>
<br> - Participant is willing to provide a self-collected saliva sample.
<br>
<br> Exclusion Criteria:
<br>
<br> - Participant has previously tested positive for COVID-19 within the past 90 days.
<br> | | COVID-19 | Diagnostic Test: AcuVid COVID-19 Rapid Antigen Saliva Test | Establish performance of AcuVid COVID-19 Rapid Antigen Saliva Test | | | | Yes | False | | |
| +++ | NCT05119543 | 15 November 2021 | Refractive Error in Chinese Students | Refractive Error in Chinese Primary and High School Students Before and Amidst COVID-19 in Tianjin | | Tianjin Eye Hospital | 01/11/2021 | 20211101 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05119543 | Recruiting | No | 6 Years | 18 Years | All | January 1, 2018 | 36452 | Observational | | | China | ; ; | Yan Wang, director;Yan Wang, director;Yan Wang, director | | ;fanqian2002_yahoo@163.com;wangyan7143@vip.sina.com | ;+8615022756478;+862227313336 | Tianjin Eye Hospital; |
<br> Inclusion Criteria:
<br>
<br> - no concurrent eye disease
<br>
<br> - age from 6 to 18 years old
<br>
<br> Exclusion Criteria:
<br>
<br> - significant systemic illnesses
<br>
<br> - ocular conditions
<br>
<br> - congenital corneal diseases
<br>
<br> - pterygium, keratoconus
<br>
<br> - corneal degeneration or dystrophy
<br>
<br> - media opacity, uveitis, glaucoma
<br>
<br> - history of ocular surgery
<br>
<br> - neurologic diseases
<br>
<br> - retinal disease.
<br> | | Myopia | Other: outdoor time | refractive error;sex disparity | | | | No | False | | |
| +++ | NCT05119608 | 15 November 2021 | Treatment of Post-covid Syndrome in Patients Treated in Intensive Care | Detection and Treatment of Long-term Symptoms - Post-covid Syndrome - in Patients Who Have Been Treated in Intensive Care for COVID-19. | | Region Skane | 11/11/2021 | 20211111 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05119608 | Not recruiting | No | 18 Years | N/A | All | November 15, 2021 | 128 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label). | N/A | Sweden | | Anders Håkansson, PhD | | anders_c.hakansson@med.lu.se | +46 46 175596 | |
<br> Inclusion Criteria:
<br>
<br> - COVID-19 survivors who screen positive for clinical anxiety or depression, defined as
<br> reaching a score of = 8 on either the anxiety or depression sub-scales within the
<br> questionnaire HADS at the standard 12-months follow-up
<br>
<br> Exclusion Criteria:
<br>
<br> - Conditions in which patients are acutely suicidal, psychotic, suffering from a mental
<br> disorder requiring in-patient psychiatric treatment, opposed to receiving a
<br> psycho-therapeutic intervention, or with cognitive problems or language difficulties
<br> which are judged to be too extensive for the informed consent procedure and for a
<br> psycho-therapeutic intervention
<br> | | COVID-19;Mental Health Disorder | Behavioral: CBT/ACT | Reduction of HADS anxiety score | | | | Yes | False | | |
| +++ | NCT05119634 | 15 November 2021 | The Effect of Whole Body Vibration Training in Individuals With Post COVID - 19 | The Effect of Whole Body Vibration Training in Individuals With Post COVID - 19 | | Istanbul University-Cerrahpasa | 28/07/2021 | 20210728 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05119634 | Recruiting | No | 18 Years | N/A | All | October 18, 2021 | 60 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Outcomes Assessor). | N/A | Turkey | ; | Nihal U Sakalli;Nihal Sakalli, own | | nihal.sakalli@istanbul.edu.tr;nihal.sakalli@istanbul.edu.tr | +905315651015;+905315651015 | |
<br> Inclusion Criteria:
<br>
<br> - positive PCR result
<br>
<br> - post covid (=12 weeks) patients aged 18 and over
<br>
<br> Exclusion Criteria:
<br>
<br> - Lack of clinical stability
<br>
<br> - Active respiratory infection (for any reason)
<br>
<br> - Any clinical condition that affects the performance of operating procedures.
<br>
<br> - advanced cancer
<br>
<br> - active infectious disease
<br>
<br> - Pregnancy or breastfeeding
<br>
<br> - Osteoarticular pathology that reduces mobility
<br>
<br> - Severe neurological disease (Parkinson's disease, dementia, amyotrophic lateral
<br> sclerosis, aphasia, ischemic stroke with significant sequelae)
<br>
<br> - have symptomatic psychiatric illness, hearing or vision impairment
<br>
<br> - Myocardial infarction within 4 months
<br>
<br> - Acute endocarditis / pericarditis
<br>
<br> - Uncontrolled high blood pressure (>180/100 mmHg)
<br>
<br> - Other cardiovascular morbidity that will limit exercise tolerance (heart failure,
<br> abnormal blood pressure responses or ST segment depression > 2mm, symptomatic aortic
<br> stenosis, complex arrhythmias)
<br>
<br> - acute thromboembolism
<br>
<br> - Patient (= 3 months) who recently received upper abdominal or thoracic surgery
<br> | | COVID-19 | Other: whole body vibration training;Other: home based exercises | Short Physical Performance Battery;6 minutes walking test;6 minutes pegboard and ring test;International Physical Activity Form (IPAQ);activity monitoring with Actigraf GT3X | | | | Yes | False | | |
| +++ | NCT05119738 | 15 November 2021 | Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Cancer Patients on Active Treatment | Immune Response to Third Dose of SARS-CoV-2 Vaccine in a Cohort of Cancer Patients on Active Treatment | | Pontificia Universidad Catolica de Chile | 10/11/2021 | 20211110 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05119738 | Recruiting | No | 18 Years | N/A | All | October 27, 2021 | 122 | Observational | | | Chile | ; | Bruno Nervi;Bruno Nervi | | bnervi@gmail.com;bnervi@gmail.com | 9978073559;+56978073559 | |
<br> Inclusion Criteria:
<br>
<br> - Vaccination with two doses of Coronavac vaccine or BNT162b2 vaccine
<br>
<br> - Eastern Cooperative Oncology group performance status < 3
<br>
<br> Exclusion Criteria:
<br>
<br> - Previous SARS-CoV-2 infection
<br>
<br> - Vaccination with booster vaccine more than 12 weeks before informed consent
<br>
<br> - Intravenous inmunoglobulin therapy 60 days before informed consent
<br>
<br> - Any condition that could interfere with the paticipant´s participation during the
<br> study in the opinion of the treating investigator.
<br> | | Sars-CoV-2 Infection | Biological: Three doses of BNT162b2 (observational);Biological: Two doses of Coronavac and one dose BNT162b2 (observational) | Proportion of positive neutralizing antibodies 8 to 12 weeks after third dose BNT162b2 (booster vaccine). | | | | Yes | False | | |
| +++ | NCT05119855 | 15 November 2021 | Safety and Immunogenicity of 9-valent Human Papillomavirus (9vHPV) Vaccine Coadministered With Messenger Ribonucleic Acid (mRNA)-1273 Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Vaccine (V503-076) | A Phase 3, Multicenter, Open-Label Study to Evaluate the Safety and Immunogenicity of 2-dose Regimens of 9vHPV and mRNA-1273 SARS-CoV-2 Vaccines Where the First Dose of Each Vaccine Are Given Concomitantly in Adolescents 12 to 14 Years of Age | | Merck Sharp & Dohme Corp. | 10/11/2021 | 20211110 | ClinicalTrials.gov | https://clinicaltrials.gov/show/NCT05119855 | Not recruiting | No | 12 Years | 14 Years | All | November 30, 2021 | 400 | Interventional | Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label). | Phase 3 | | | Medical Director | | | | Merck Sharp & Dohme Corp. |
<br> Inclusion Criteria:
<br>
<br> - Has not yet had coitarche and does not plan on becoming sexually active during the
<br> vaccination period
<br>
<br> - Participant or participant's legally acceptable representative can read, understand,
<br> and complete the electronic vaccination report card (eVRC).
<br>
<br> Exclusion Criteria:
<br>
<br> - Known allergy to any vaccine component
<br>
<br> - History of severe allergic reaction that required medical intervention
<br>
<br> - Thrombocytopenia or any coagulation disorder
<br>
<br> - Has a history of myocarditis or pericarditis
<br>
<br> - Has a history of a clinical or microbiological diagnosis of COVID-19, including a
<br> diagnosis of multisystem inflammatory syndrome in children
<br>
<br> - Females only: participant is pregnant or expecting to donate eggs during day 1 through
<br> month 7
<br>
<br> - Currently immunocompromised, or been diagnosed with immunodeficiency
<br>
<br> - Had a splenectomy
<br>
<br> - Receiving or has received immunosuppressive therapies within the last year
<br>
<br> - Received any immunoglobulin product or blood-derived product within 3 months
<br>
<br> - Received a marketed HPV vaccine or has participated in an HPV vaccine clinical trial
<br> | | Papillomavirus Infections;Coronavirus Disease (COVID-19) | Biological: 9vHPV Vaccine;Biological: mRNA-1273 Vaccine | Percentage of Participants with at Least 1 Vaccine-Related SAE;Percentage of Participants with at Least 1 Serious Adverse Event;Percentage of Participants with at Least 1 Solicited Systemic AE;Percentage of Participants with at Least 1 Solicited Injection-site Adverse Event;Geometric Mean Concentrations of SARS-CoV-2 Spike Protein-Specific Binding Antibodies;Geometric Mean Titers of Anti-Human Papillomavirus Types 6, 11, 16, 18, 31, 33, 45, 52, and 58 | | | | Yes | False | | |
| +++ | ACTRN12621001535864 | 15 November 2021 | Ivermectin to prevent Coronavirus | A pilot randomized placebo-controlled double-blind trial of single dose oral Ivermectin for post-exposure prophylaxis in close contacts of SARS-CoV-2 | | Monash University | 10/11/2021 | 20211110 | ANZCTR | https://anzctr.org.au/ACTRN12621001535864.aspx | Not Recruiting | No | 18 Years | 80 Years | Both males and females | 22/11/2021 | 1000 | Interventional | Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Blinded (masking used);Assignment: Parallel;Type of endpoint: Efficacy; | Phase 3 | Australia | | | | | | | Inclusion criteria: 1. In the preceding 72 hours, had close contact with a person infectious with SARS-CoV-2 (COVID-19).
<br>• AND that contact was in the context of i) a participant’s home or ii) an indoor work environment or iii) a family gathering or a social or a religious function or a ceremony each being of less than 30 people.
<br>• AND since that contact, tested negative for SARS-CoV-2 on polymerase chain reaction (PCR) of pharyngeal swab.
<br>• AND are asymptomatic of fever, cough, sore throat, rhinorrhoea, loss of smell, loss of taste, or more difficulty breathing than usual.
<br> | Exclusion criteria: • Residing outside the current geographic recruitment area
<br>• The close contact with an infectious index case of SARS-CoV-2 occurred in a hospital
<br>• The index case who has SARS-CoV-2 lives in the same residence as the potential participant.
<br>• Another person who lives in the same residence as the potential participant has returned a positive pharyngeal PCR for SARS-CoV-2 in the last 2 weeks.
<br>• Unable to provide the name, address and phone number of the potential participant’s general practitioner/primary care physician OR does not have such a general practitioner/primary care physician.
<br> • Has not attended a doctor at the practice of the above general practitioner/primary care physician for more than 12 months. (NB Given the pandemic, that attendance may have been by telehealth).
<br>• Lives alone (as potentially at higher risk should there be a serious adverse event).
<br>• Unable to provide the name and phone number of a back-up contact person.
<br>• History of past infection with SARS-CoV-2.
<br>• Use of Ivermectin for any purpose in 5 weeks prior to enrolment.
<br>• Known past allergy or severe adverse reaction to Ivermectin.
<br>• Weight <45kg or > 120kg.
<br>• Pregnant or breast feeding.
<br>• Not willing to refrain from falling pregnant or fathering a child for 6 months after last dose of investigational product.
<br>• Cirrhosis or known decompensated liver disease (Child-Pugh B or C).
<br>• Current use, or use within the last 3 months, of the drug amiodarone.
<br>• Current use of any of the following drugs: warfarin, verapamil, diltiazem, quinidine, spironolactone, ciclosporin, tacrolimus, cobicistat, indinavir, ritonavir, didanosine (DDI), ketoconazole, itraconazole, fusidic acid, erythromycin, clarithromycin.
<br>• Past sedation or somnolence from products containing codeine
<br>• History of residency or travel to loa loa endemic areas (“Angola, Cameroon, Central African Republic, Chad, Democratic Republic of Congo, Ethiopia, Equatorial, Guinea, Gabon, Republic of Congo, Nigeria and Sudan”, Chaccour et al 2020 Trials. Jun 8;21(1):498).
<br>• Severe Asthma
<br>• Encephalopathy.
<br>• Head injury requiring medical attention in the last 6 months.
<br>• Concussion within the last 6 months.
<br>• Fit, seizure, stroke, TIA (transient ischaemic attack) or transient global amnesia in the last 6 months.
<br>• History of Epilepsy
<br>• Dementia of any type.
<br>• Not usually fully independent in activities of daily living and self-care including: washing, toileting, dressing and dental care.
<br>• Inability of participant or person responsible to communicate to the level necessary to provide verbal or written consent.
<br>• Incarcerated by local, state or federal authorities.
<br>• Conditions which in the opinion of the investigative team would make successful trial completion (including follow up data collection) unlikely, for example including uncontrolled substance use, poorly controlled mental state disorder.
<br>• Unable to advise trial staff of Coronavirus vaccination status including date of administration of last vaccine dose.
<br>• Already enrolled in another Coronavirus RCT
<br>• In Australia, lack of a valid Medicare number | COVID-19;SARS-CoV-2; <br>COVID-19 <br>SARS-CoV-2;Infection - Other infectious diseases;Respiratory - Other respiratory disorders / diseases;Public Health - Epidemiology | Single dose of ivermectin 200ug/kg orally or matching placebo tablets. The trial will recruit participants who have, in the preceding 72 hours, had close contact with a person infectious with SARS-CoV-2. Participants must have, since that contact, tested negative for SARS-CoV-2 on polymerase chain reaction (PCR) of pharyngeal swab and be asymptomatic of: fever, cough, sore throat, rhinorrhoea, loss of smell, loss of taste, or more difficulty breathing than usual. The PCR test is required to determine qualification for the study but is not performed as part of the study.<br>Participants will be randomized 1:1 to receive either Ivermectin 200ug/kg orally or Placebo tablets on Day 1. Approximately 4 hours of receipt of the study drug the participants will be contacted by staff from the CRO and asked whether all study tablets were taken and, if not, why not. <br>The trial will recruit until 40 participants (regardless of randomisation allocation) have converted to a positive PCR for SARS-CoV-2 within 14 days of their contact with an infectious SARS-CoV-2 index case.<br> | Amongst the 40 participants who convert to a positive PCR for SARS-CoV-2, the proportion who received Ivermectin. <br>To determine this, participants will be asked whether they took some/all of the study drug, Their information will be entered into the study database (REDCap) which will also contain their treatment allocation (only the study Pharmacists are unblinded to this information prior to database lock). [14 days after initial COVID-19 close contact] | | | | Yes | False | | |
| +++ | ACTRN12621001513808 | 15 November 2021 | Free Jab (COVID-19) Control group in Australia
Health and risk outcomes for Australians who not intending to receive the COVID-19 vaccination. | Health outcomes for Australians who do not intend to receive the COVID-19 vaccination. | | Sylvia Smart | 05/11/2021 | 20211105 | ANZCTR | https://anzctr.org.au/ACTRN12621001513808.aspx | Not Recruiting | No | 6 Months | 100 Years | Both males and females | 01/12/2021 | 1000 | Observational | Purpose: Natural history;Duration: Longitudinal;Selection: Defined population;Timing: Prospective; | Not Applicable | Australia | | | | | | | Inclusion criteria: Adults who don’t have yet received any of the COVID-19 vaccinations and are not planning to do this.
<br>Parents/guardians who have been vaccinated against COVID-19 but want to add unvaccinated relatives can create a record to add them.
<br>Ability and willingness to comprehend and consent in a timely manner. | Exclusion criteria: Current hospitalization with COVID-19
<br>Receipt of a COVID-19 vaccination
<br>Unable to complete online questionnaires or follow study guidelines. | Not vaccinated against COVID-19;Not planning to receive COVID-19 vaccinations; <br>Not vaccinated against COVID-19 <br>Not planning to receive COVID-19 vaccinations;Infection - Other infectious diseases;Respiratory - Other respiratory disorders / diseases;Inflammatory and Immune System - Normal development and function of the immune system | This is an independent one-year term study<br> - Australians who are not vaccinated against COVID-19<br> - Monthly survey consultation (PARTICIPANT QUESTIONNAIRE (follow-ups)<br>1. Do you have any COVID-19 symptoms?<br>respiratory problems (cluster with cough)<br>sputum<br>shortness of breath<br>fever<br>muscle and joint pain<br>headaches<br>fatigue<br>Loss of smell or taste<br>2. Did you recently have the COVID-19 test?<br>negative<br>positive <br>3. Do you sick for last month?<br>yes (if yes what it was?) <br>no <br>4. Do you visit your GP or other specialists last month?<br>yes (if yes, what is the reason)<br>no<br>5. Do you get the COVID-19 vaccine last month?<br>No<br>Yes ( withdraw ) <br><br>IF COVID-19 TESTS POSITIVE<br>Are you hospitalised (Yes. No) <br>Are you take any drugs (what kind?) <br>Are you taking any supplements (name and dose) <br>Would you like still to participate in this study (Yes No) <br>If No (reason-? COVID-19 Vaccine taken or other)<br>If vaccine Covid -19 is taken participants have to be withdrawn <br><br>IF THE PARTICIPANT HAS COVID-19 SYMPTOMS <br>(Send a letter with a recommendation to take COVID-19 test) <br><br>EXIT QUESTIONS <br>What is your reason to leave this study <br>Vaccination (COVID-19) <br>Join another study <br>Other (write your reason) <br><br> - Record any changes in the health of the participant<br> - No pharmaceutical drugs apply for this study <br> - Researcher will be administering or delivering these activities | Deaths among participants with newly diagnosed COVID19 <br>Data will collect from an online survey (Monthly)[Time Frame: 52 weeks <br>Frequency of assessments: every 4 weeks for 52 weeks in total];For COVID19-related symptoms or problems <br>Online survey monthly, which will take about 5 minutes.[Time Frame: 52 weeks <br>Frequency of assessments: every 4 weeks for 52 weeks in total,] | | | | Yes | False | | |
| +++ | ACTRN12621001519842 | 15 November 2021 | The Herekorenga - Freedom Study - Understanding COVID-19 antibody levels to help open up Aotearoa New Zealand | Using the PictArray™ SARS-CoV-2 IgG ELISA Test to better understand COVID-19 antibody levels within the Aotearoa New Zealand population. | | Pictor | 09/11/2021 | 20211109 | ANZCTR | https://anzctr.org.au/ACTRN12621001519842.aspx | Not Recruiting | No | 19 Years | No limit | Both males and females | 15/11/2021 | 300 | Interventional | Purpose: Diagnosis; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Other;Type of endpoint: Efficacy; | Not Applicable | New Zealand | | | | | | | Inclusion criteria: Participation by people of all genders, ages and ethnicities is encouraged in this study. Pictor would like to get a representative
<br>selection of Aotearoa New Zealand’s unique population.
<br>We are especially encouraging people who fall into the following categories to become involved in this study.
<br>I. People who have been infected with COVID-19
<br>II. People who have been vaccinated (one (1) or two (2) doses)
<br>III. People who have not been infected with COVID-19 and have not been vaccinated | Exclusion criteria: I. Participant has not given consent to use of their sample
<br>II. The sample was not properly collected, labelled, transported, processed or stored according to instructions provided by Pictor to
<br>the independent laboratory. | COVID-19 ; <br>COVID-19 ;Infection - Other infectious diseases | Participants will be required to attend the designated Tend Medical Clinic (in Auckland) at a pre-arranged time, where all documentation such as the questionnaire and PISCF will be reviewed. If there are any further questions these can be answered at this point in time. Once the participant is happy to continue the process a medical professional will obtain a saliva sample, and a blood sample of approximately 20 mL, for analysis in the study. This will be the only time a sample from participants will be taken for this study. It is estimated participants will require 20 - 30 minutes to complete documentation and sample collection.<br>These samples will each be deidentified by being given a Pictor study participant code before being taken to the IGENZ laboratory for processing and analysis of the samples on the PictArray™ SARS-CoV-2 IgG Enzyme linked immunosorbent assay (ELISA) . This allows the analysis to be conducted under blinded study conditions. Pictor will then receive the data from the samples for further statistical analysis. A report detailing the presence or absence of antibodies towards the COVID-19 virus spike and nucleocapsid proteins will be compiled using this analysis.<br> | This clinical trial would assess the Spike protein (SP) and Nucleocapsid protein (NP) ratio in serum found in different populations : naïve, previously infected individuals and vaccinated individuals by PictArray™ SARS-CoV-2 IgG ELISA.[Once only - on the day of enrolment at the Tend Medical Clinic] | | | | Yes | False | | |
| +++ | ACTRN12621001524886 | 15 November 2021 | Queensland COVID-19 Vaccination (QoVAX) Safety and Efficacy Trial Program: Mixed Dose 1 and 2 Study
| Queensland COVID-19 Vaccination (QoVAX) Safety and Efficacy Trial Program: Mixed Dose 1 and 2 Study | | Metro North Hospital and Health Service | 09/11/2021 | 20211109 | ANZCTR | https://anzctr.org.au/ACTRN12621001524886.aspx | Not Recruiting | No | 18 Years | No limit | Both males and females | 06/12/2021 | 2000 | Observational | Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Both; | Not Applicable | Australia | | | | | | | Inclusion criteria: People in Queensland 18 years of age and older, who have received two doses of BNT162b2 or ChAdOx1 COVID vaccines, the second of which was received between 120-180 days prior to giving consent, | Exclusion criteria: 1. Unable or decline to give informed consent
<br>2. Have a contraindication to venepuncture
<br>3. Insufficient literacy to read and understand the English or translated version of the participant information and consent forms who do not have a family member or interpreter to assist
<br>4. Do not posses a smart phone or computer to access the participant information and complete the consent form and fill the questionnaire.
<br>5. Are unable or unwilling to reach a pathology collection centre to donate samples.
<br> | COVID-19;SARS-CoV-2; <br>COVID-19 <br>SARS-CoV-2;Infection - Other infectious diseases;Inflammatory and Immune System - Normal development and function of the immune system;Respiratory - Other respiratory disorders / diseases | Heterologous COVID-19 vaccines (BNT162b2 (BioNTech, Pfizer)/ChAdOx1 (Oxford, AstraZeneca) or ChAdOx1/BNT162b2) for doses 1 and 2<br><br>Participants complete a questionnaire and have blood and saliva samples collected at 4 - 6 months post the second vaccine dose. The questionnaire and samples are repeated at 12-months post the date of recruitment. | Serum IgG antibodies titres to the SARS-CoV2 spike protein measured using Abbott Core Laboratories' chemiluminescent microparticle immunoassay (CMIA) [4 - 6 months from the second dose of vaccine and at 12 months following the date of recruitment] | | | | Yes | False | | |
| +++ | ACTRN12621001543875 | 15 November 2021 | Queensland COVID-19 Vaccination (QoVAX) Safety and Efficacy Trial Pilot Study in adults aged 18 years and over. | Queensland COVID-19 Vaccination Safety and Efficacy Trial (QoVAX SET) Program – Pilot Phase Study in adults aged 18 years and over. | | Metro North Hospital and Health Service | 12/11/2021 | 20211112 | ANZCTR | https://anzctr.org.au/ACTRN12621001543875.aspx | Recruiting | No | 18 Years | No limit | Both males and females | 21/07/2021 | 3000 | Observational | Purpose: Screening;Duration: Longitudinal;Selection: Defined population;Timing: Prospective; | Not Applicable | Australia | | | | | | | Inclusion criteria: People over 18 years of age who:
<br>a) are eligible for the Queensland Health (QH) COVID vaccine program
<br>b) register to receive the vaccine at participating QH sites | Exclusion criteria: a) Not resident in Queensland
<br>b) Unable or decline to give informed consent
<br>c) Have a contraindication to venepuncture
<br>d) do not speak/read English well enough to understand the participant information form and complete the surveys | COVID-19;SARS-CoV2 virus immunity; <br>COVID-19 <br>SARS-CoV2 virus immunity;Infection - Other infectious diseases;Respiratory - Other respiratory disorders / diseases;Inflammatory and Immune System - Normal development and function of the immune system | COVID-19 vaccines: BNT162b2 (BioNTech, Pfizer) or ChAdOx1 (Oxford, AstraZeneca)<br><br>Participants will be recruited prior to the first dose of vaccine. A participant completed questionnaire and blood and saliva samples are collected prior to vaccination. The survey and blood and saliva specimens are repeated just prior to the second dose of vaccine and then at 4 weeks, 6 months and 12 months post the second dose of vaccine. | Serum IgG antibodies to the SARS-CoV2 spike protein measured with the Abbott Architect system[1 month post the second dose of vaccine];Cytokine response including gamma interferon and other cytokines involved in cell mediated adaptive immune response to virus (IL1 alpha, TNFalpha, IL-2, IL-6, IL-8, IL-10, IL-5) will be tested on either freshly collected whole blood or cryopreserved peripheral blood (QuantiFERON gold assay and by stimulating cryopreserved peripheral blood mono nuclear cells and cytokine bead array analysis (Legendplex) of culture supernatants [1 month post the second dose of vaccine] | | | | No | False | | |
| +++ | ISRCTN54053617 | 15 November 2021 | Defining the composition of the outer surface of the coronavirus | Mapping the lipid envelope composition of SARS-CoV2 for reducing transmission, thrombosis, and inflammation | | Cardiff University | 15/11/2021 | 20211115 | ISRCTN | https://www.isrctn.com/ISRCTN54053617 | Recruiting | No | | | Both | 01/12/2021 | 100 | Observational | Observational cohort study (Other) | Not Applicable | Wales;United Kingdom | Wendy | Powell |
Cardiff University School of Medicine
Heath Park
| powellw1@cardiff.ac.uk | +44 (0) 2920 744252 | | Inclusion criteria: Adults (=18 years old) who have PCR-positive testing for COVID-19 in the last 5-days, who are able to provide written informed consent. | Exclusion criteria: Does not meet inclusion criteria | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> Eligible participants will be identified in screening programmes undertaken routinely by Public Health Wales (PHW). PHW will only share positive PCR results of patients in the population of HB involved in the study. Their name, hospital number and date of positive PCR result will be reported to the HB’s R&D team who are named on the delegation log for processing such information. These individuals can use their own Health Board medical system/records to obtain up-to-date contact details to make contact to see if they are interested in taking part in the study. Identification of positive covid-19 patients to the R&D dept will be via contacts in PHW who routinely process PCR tests for Hospitals and community settings. PHW will provide patient name and hospital for a member of the research team, to make contact with the potential participant, and they will be given the opportunity to ask questions about the study.<br><br> The participants can either choose a hospital setting (“Red Zone” or “drive-in” testing centre) or their own home for sample collection. A designated member of the research team will go through the PIS, answer any questions before obtaining face-to-face consent and collecting the saliva sample.<br><br> All saliva samples should be collected as soon as possible or within 5 days of the positive PCR result. Participants will be given a minimum of 30-minutes to decide but they can have more time if they wish, permitting the saliva sample is collected in line with the study protocol timeframe from 5 days of the positive PCR test result. Those who wish to take part will be required to complete the written Consent Form (see attached) and saliva will be collected by "spitting" into a sterile tube and collected by the staff id | SARS-CoV2 envelope characterisation, within 5 days of a positive PCR test (time Zero) , analysed using Mass Spectrometry Lipidomics following collection at a single timepoint | | 01/09/2022 | | Yes | False | | |
| +++ | ISRCTN52588893 | 15 November 2021 | COVID-19 vaccine efficacy evaluation in kidney failure patients | Sarscov2 immunity Evaluation post-vaccination iN patIentS On Renal replacement therapy | | Royal Liverpool University Hospital | 15/11/2021 | 20211115 | ISRCTN | https://www.isrctn.com/ISRCTN52588893 | Recruiting | No | | | Both | 02/08/2021 | 750 | Observational | Prospective observational cohort study (Prevention) | Not Applicable | United Kingdom;England | | | | | | | Inclusion criteria: <br> 1. Age of 18 years or older<br> 2. Renal Replacement Therapy patients (dialysis and renal transplant) who have received the SARS-CoV-2 vaccine<br> 3. A comparative arm of Renal Replacement Therapy patients (dialysis and renal transplant) who have refused the SARS-CoV-2 vaccine<br> 4. Capable of understanding the purpose and risks of the study, fully informed and given informed consent<br> | Exclusion criteria: <br> 1. Pregnancy or breastfeeding<br> 2. Active (haematological) malignancy<br> 3. Inherited immune deficiency<br> 4. Infection with Human Immunodeficiency Virus (HIV)<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> 1. Assessment of immune response<br> The measurement of SARS-CoV2 specific antibodies will be using the Elecsys Anti-SARS-CoV-2 S assay (Elecsys Anti-SARS-CoV-2 S.09289275500v1.0).<br><br> This study is a pragmatic study with the timing of blood samples required for study in the three cohorts centred around the patients routine clinical monitoring, monthly in dialysis patients, and 4 monthly intervals (monthly if logistically possible) for renal transplant patients.<br><br> Dialysis patients will have their study samples monthly with their routine monthly blood monitoring on dialysis by nurses. Home dialysis patients will self-obtain the study samples with their routine monthly blood monitoring. Renal transplant patients will have their study samples at 4 monthly intervals (monthly if logistically possible) and blood tests are taken for their clinic visits by the trust phlebotomy service.<br><br> Given that the substantial proportion of participants will have had their first dose of the SARS-CoV2 vaccine, this study intends to utilise stored samples (HLA-specific antibodies and Post-Transplant Save Serum) at Liverpool University Hospitals NHS Foundation Trust pathology department(s) / diagnostic archive(s) for the baseline samples.<br><br> The study’s blood sampling schedule for assessment of immune response in the four cohorts is detailed below.<br><br> Cohort 1 Vaccinated dialysis patients on the UK renal transplant waiting list<br> Blood/serum for antibody to COVID 19 vaccination at baseline (stored sample-transplant listing blood tests), 21 days post 1st dose of the SARS-CoV-2 vaccine (stored sample -transplant listing blood tests), 21 days post 2nd dose of the SARS-CoV-2 vaccine a | Level of antibody-based immune response measured using the Roche COVID-19 antibody quantitative assay (Elecsys Anti SARS CoV 2 S assay (Elecsys Anti-SARS-CoV-2 S.09289275500v1.0)) on day 21 after the second SARS-CoV-2 vaccine | | 15/10/2022 | | No | False | | |
| +++ | ISRCTN17123528 | 15 November 2021 | Translation of questionnaires on quality of life, disability, self-esteem, and stigma into Kinyarwanda (the language of Rwanda) | A COVID-19 pandemic adapted framework for international collaboration on the cross-cultural translation of questionnaires on quality of life, disability, stigma, self-esteem, and wealth into Kinyarwanda using a mixed multistep approach with early involvement of patients living with epilepsy and healthy volunteers | | Ghent University Hospital | 15/11/2021 | 20211115 | ISRCTN | https://www.isrctn.com/ISRCTN17123528 | Recruiting | No | | | Both | 06/07/2021 | 55 | Other | International collaboration single-center study using a mixed approach (Other) | Not Applicable | Rwanda | | | | | | | Inclusion criteria: <br> A) Patients with epilepsy (N=2) included in panel discussions<br> 1. Definite clinical diagnosis of epilepsy, defined as two epileptic seizures, unprovoked, with a minimum interval of 24 hours<br> 2. Able to read self-administered questionnaires and able to write<br> 3. Bilingual English and Kinyarwanda, preferably trilingual French, English, Kinyarwanda<br> 4. Able to attend/complete computer-assisted personal interviewing<br> 5. Willing to attend video conferencing and CASI<br> 6. = 18y of age<br> 7. Providing signed informed consent<br><br> B) Healthy volunteers (N=2) included in panel discussions<br> 1. Able to read<br> 2. = 18y of age<br> 3. Willing to attend video conferencing and CASI<br> 4. Provide signed informed consent<br><br> C) Volunteers (N=30) enrolled for assessment of similarity/comparability of the original version (OV) and Back translation (BT)<br> 1. Fluent in English<br> 2. Able to attend/complete CASI<br> 3. = 18y of age<br> 4. Providing signed informed consent<br><br> D) Patients (N=5) for testing of prefinal version<br> 1. Definite clinical diagnosis of epilepsy, defined as two epileptic seizures, unprovoked, with a minimum interval of 24 hours<br> 2. Able to understand and respond to the questionnaire<br> 3. = 18y of age<br> 4. Provide signed informed consent<br><br> E) Healthy Volunteers (N=5) for testing of prefinal version<br> 1. Able to understand and respond to the questionnaire<br> 2. = 18y of age<br> 3. Provide signed informed consent<br><br> F) Healthcare Professional (N=5) for testing of prefinal version<br> 1. = 18y of age<br> 2. Board-certified healthcare professional in Rwanda<br> 3. Fluent in Kinyarwanda<br> 4. Provide signed informed consent<br> | Exclusion criteria: <br> A) PwE (N=2) included in panel discussions<br> 1. Presence of cognitive deficit hampering interview, comprehension of questions<br> 2. Presence of neurological deficit that hinders answering of questions, reading, or understanding<br> 3. Presence of hallucinations, psychosis<br><br> B) HVs (N=2) included in panel discussions<br> 1. Presence of any medical condition unless treatment provides total symptom control for at least 6 months or unless judged healthy by the enrolling investigator<br> 2. Presence of cognitive deficit, possibly hampering participation or reading, understanding or answering of questions,<br> 3. Presence of hallucinations, psychosis<br><br> C) volunteers (N=30) enrolled for assessment of similarity/comparability of the original version (OV) and Back translation (BT)<br> 1. Presence of physical condition hampering reading, understanding or answering<br> 2. Presence of hallucinations, psychosis<br><br> D) Patients (N=5) for testing of prefinal version<br> 1. Presence of cognitive deficit hampering interview, comprehension of questions<br> 2. Presence of neurological deficit that hinders answering of questions, reading or understanding<br> 3. Presence of hallucinations, psychosis<br><br> E) Healthy Volunteers (N=5) for testing of prefinal version<br> 1. Presence of any medical condition unless treatment provides total symptom control for at least 6 months or unless judged healthy by the enrolling investigator<br> 2. Presence of cognitive deficit, possibly hampering participation or reading, understanding or answering of questions,<br> 3. Presence of hallucinations, psychosis<br><br> F) Healthcare Profession (N=5) for testing of prefinal version<br> 1. Presence of any medical condition unless treatment provides total symptom control for at least 6 months or unless judged healthy by the enrolling investigator<br> 2. Presence of cognitive deficit, possibly hampering participation or reading, understanding or answering of questions<br> | Translation of questionnaire on (health-related) quality of life, self-esteem, disability, and stigma for Rwandan patients with epilepsy and volunteers <br>Not Applicable | <br> Different samples of study subjects will be recruited during the project.<br> A) Panel members enrolled in step 1 to 9, participate for the full study and will attend panel meetings and participate actively in a consensus discussion. In step 3, they complete once an online content validity assessment questionnaire, thorugh a computer-assisted self-interview.<br> B) Healthy volunteer enrolled in step 6 for comparability/similarity assessment, complete once an online comparability/similarity questionnaire on all items, through a computer-assisted self-interview<br> C) Patients or healthy volunteer enrolled in step 8 for for prefinal version testing, complete the Kinyarwanda versions of all questionnaires once and are subject to an in-depth interview for each item through a computer-assisted personal interview.<br> D) Healthcare professional enrolled in step 8 for for prefinal version testing, complete the Kinyarwanda versions of all questionnaires once and and complete a user preference questionnaire thorugh a computer-assisted self-interview.<br><br> Step 1: Forward Translation: three forward translators provide translation from English to Kinyarwanda of all items, including response options.<br> Step 2: Forward translation reconciliation: the expert panel creates a single Kinyarwanda translation based on the forward translations from step 1, reviews and approves the version<br> Step 3: Content Validity Assessment: the expert panel assesses all items of each questionnaire in terms of relevance both conceptually and culturally, using a content validity questionnaire<br> Step 4: Final Forward translation: the expert panel reviews the content validity indices by it | Content Validity is measured using the item content validity index (I-CVI), Scale-CVI, proportional index and unanimity agreement score, at a single time point (step 3) | | 15/01/2022 | | No | False | | |
| +++ | ISRCTN11681816 | 15 November 2021 | Effects of the amount of SARS-CoV-2 in the maternal airways on outcomes before, during, and after childbirth | Effect of SARS-CoV-2 estimated nasopharyngeal viral load on perinatal outcomes in pregnant women affected by COVID-19 during the third trimester (VALOROUS study) | | Hôpital Antoine-Béclère | 08/11/2021 | 20211108 | ISRCTN | https://www.isrctn.com/ISRCTN11681816 | Not Recruiting | No | | | Female | 01/03/2020 | 100 | Observational | Multicenter international observational retrospective cohort study (Other) | Not Applicable | Belgium;France;Italy;United Kingdom;England | Daniele | De Luca |
Service de Pédiatrie et Réanimation Néonatale,
Hôpital “A. Béclère”, GHU Paris Saclay - APHP
157 rue de la Porte de Trivaux
| dm.deluca@icloud.com | +33 (0)145374837 | | Inclusion criteria: <br> 1. Third trimester of pregnancy<br> 2. Diagnosis of COVID performed according to World Health Organization criteria<br> 3. Viral load estimated by real-time polymerase chain reaction cycle threshold (Ct) for any viral gene<br> | Exclusion criteria: <br> 1. Fetal congenital malformations<br> 2. Major genetic or chromosomal abnormalities<br> 3. Ongoing pregnancies at the time of the analysis<br> 4. Missing viral load or outcome data<br> | Effect of SARS-CoV-2 estimated nasopharyngeal viral load on perinatal outcomes in pregnant women affected by COVID-19 during the third trimester <br>Pregnancy and Childbirth | <br> Nasopharyngeal swabs will be obtained following US Center for Disease Control and Prevention guidelines. Extraction and amplification will be performed with commercial assays validated for SARS-CoV-2 diagnosis by WHO or local healthcare authorities. Manufacturer’s recommendations will always be followed. The SARS-CoV-2 load will be estimated for any viral gene, according to each laboratory protocol. RT-PCR technique will be performed according to European Center for Disease Prevention and Control.<br><br> The following data will be collected: basic maternal and neonatal demographics, birth weight Z-score, time between COVID-19 diagnosis and delivery, 5’ Apgar score, cord pH, estimated viral load for any vital gene, COVID-19 severity. These variables were chosen in order to keep a pragmatic design and make from the different centers easy to merge.<br><br> Data will be collected retrospectively to the start of the pandemic and prospectively to the end of the study.<br> | <br> 1. Estimated viral load measured at birth using the number of cycles at the RT-PCR on maternal nasopharyngeal swab according to best microbiological practice<br> 2. Gestational age at the birth measured using patient records<br> 3. Birth weight and its Z-score measured using patient records<br> 4. 5’Apgar score measured at birth by adequately trained midwives or neonatologists<br> 5. Cord pH measured at birth using potentiometric point of care method on cord arterial puncture<br> | | 31/08/2021 | | No | False | | |
| +++ | ISRCTN16033549 | 15 November 2021 | Using activity tracking and just-in-time messaging to improve adaptive pacing in people with long COVID: a pragmatic randomised control trial | A randomised controlled trial of activity tracking and JITAI managed adaptive pacing for symptoms of post-exertional malaise in people with long-COVID | | University of the West of Scotland | 08/11/2021 | 20211108 | ISRCTN | https://www.isrctn.com/ISRCTN16033549 | Recruiting | No | | | Both | 01/12/2021 | 172 | Interventional | Pragmatic single centre randomized controlled trial (Quality of life) | Not Applicable | United Kingdom;Scotland | Lawrence;Nicholas | Sculthorpe;Hayes |
The University of the West of Scotland
Lanarkshire Campus
Stephenson Place
Hamilton International Technology Park
Blantyre
;
The University of the West of Scotland
Lanarkshire Campus
Stephenson Place
Hamilton International Technology Park
Blantyre
| nicholas.sculthorpe@uws.ac.uk;lawrence.hayes@uws.ac.uk | +44 (0)1698 283100;+44 (0)1698 283100 | ; | Inclusion criteria: <br> 1. Adults reporting persistent symptoms which have lasted for at least 8-weeks after initial infection with COVID-19 and which interfere with day-to-day activity.<br> 2. Participants should be recovering at home and have access to an Android (SDK16 or higher) or iPhone (iOS version 10 or higher) mobile phone.<br> | Exclusion criteria: <br> 1. Currently receiving ongoing care for LC via primary or secondary care services.<br> 2. Prior diagnosis with a comorbidity with similar symptoms (e.g. ME/CFS).<br> 3. Currently receiving a therapy known to cause exacerbations.<br> 4. Currently participating in another LC focussed intervention.<br> 5. Impaired cognitive function which compromises comprehension of study information or messaging.<br> 6. Insufficient English language for messaging to be effective.<br> 7. No mobile phone access<br> | Reducing frequency and severity of post-exertional malaise in people with long COVID. <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> 250 participants with long COVID will be randomised into intervention and control groups using a secure, independent online trial allocation service. Allocation will be stratified for age and sex.<br><br> 125 Participants in the control group will receive standard advice on pacing and managing energy levels. Participants in the intervention group will receive an activity tracker and a bespoke mobile phone 'App'. Each day, using their activity tracking data intervention participants will receive individualised alert messages when they spend time above a specific HR determined activity threshold (eg. time above 130 bpm) and if they have not spent sufficient time at rest.<br> | Post-exertional malaise using the PEM questionnaire at baseline and at 6 months. | | 31/12/2022 | | Yes | False | | |
| +++ | ISRCTN30448031 | 15 November 2021 | A clinical trial investigating novel treatments for COVID-19 in the community | Platform Adaptive trial of Novel antivirals for early treatment of COVID-19 in the community | | University of Oxford | 03/11/2021 | 20211103 | ISRCTN | https://www.isrctn.com/ISRCTN30448031 | Recruiting | No | | | Both | 15/11/2021 | 5319 | Interventional | Platform randomized controlled trial (Treatment) | Not Applicable | Wales;Scotland;Northern Ireland;England;United Kingdom | | | | | | | Inclusion criteria: <br> 1. Participant or their legal representative is able and willing to provide informed consent<br> 2. Symptoms attributable to COVID-19 started within the past 5 days and ongoing<br> 3. A positive PCR SARS-CoV-2 test within the past 7 days<br> 4. Aged =50 years OR aged 18-49 years with any known underlying chronic health condition considered to make them clinically vulnerable:<br> 4.1. chronic respiratory disease (including chronic obstructive pulmonary disease (COPD), cystic fibrosis and asthma requiring at least daily use of preventative and/or reliever medication)<br> 4.2. chronic heart or vascular disease<br> 4.3. chronic kidney disease<br> 4.4. chronic liver disease<br> 4.5. chronic neurological disease (including dementia, stroke, epilepsy)<br> 4.6. severe and profound learning disability<br> 4.7. Down’s syndrome<br> 4.8. diabetes mellitus (Type or Type II)<br> 4.9. immunosuppression due to disease or treatment (e.g., sickle cell, HIV, cancer, chemotherapy)<br> 4.10. solid organ, bone marrow and stem cell transplant recipients<br> 4.11. morbid obesity (BMI >35)<br> 4.12. severe mental illness<br> 4.13. care home resident<br> 4.14. judged by recruiting clinician or research nurse (registered medical practitioner or trained study nurse) to be clinically vulnerable<br> | Exclusion criteria: <br> 1. Patient currently admitted to hospital<br> 2. Previous randomisation in the PANORAMIC trial<br> 3. Currently participating in a clinical trial of a therapeutic agent for acute COVID-19<br> 4. Participation in an investigational COVID-19 vaccine trial within previous 28 days<br> 5. Additional exclusions specific to each intervention arm, if any, as listed in the Intervention Specific Appendices (ISA’s) of currently open trial arms<br> | COVID-19 (SARS-Cov-2-infection) <br>Infections and Infestations | <br> A platform trial, in contrast to say a traditional two-arm design, allows multiple arms to be considered simultaneously, and interventions can be dropped and replaced as evidence emerges for effectiveness or lack of it. The intent is to establish an on-going trial infrastructure within a master protocol that uses all the data already accumulated for the assessment of current and subsequently introduced interventions. New interventions will only be added after submission to the appropriate approval bodies.<br><br> The trial will initially be two arms comparing usual care to usual care + Anti viral agent (name hidden for blinding) treatment. four 200mg tablets (800mg) will be taken by participants ever 12 hours (twice a day) for five days. This produce is licensed for emergency use in the UK (i.e. under trial circumstances).<br><br> Randomisation:<br> Participants will be randomised using a secure, fully validated and compliant web-based randomisation system. Once deemed eligible, the medically qualified clinician or research nurse from the central clinical team or Hub (as documented on the delegation log) will randomise the participant. Participants will be randomised to one study arm using equal allocation ratios corresponding to the number of eligible arms in the trial. For instance, if there are two active interventions (A & B), the allocation ratio will be 1:1:1 for Usual Care, active A, active B (respectively), such that 33% of participants are randomised to Usual Care. If there are 3 active interventions, the allocation ratio will be 1:1:1:1, such that 25% of participants are randomised to Usual Care. Patients must be eligible for at least two arms (Usual Care and at least one novel antiviral intervention). Stratificat | Non-elective hospitalisations/deaths in higher risk, symptomatic patients with confirmed COVID-19 within 28 days of randomisation measured using patient records. | | 30/09/2023 | | Yes | False | | |
| → | ISRCTN59503725 | 1 November 2021→15 November 2021 | The effects of monetary incentives on COVID-19 vaccination uptake | Cluster-level spillover randomized controlled trial to assess the impact of monetary incentives on COVID-19 vaccination uptake among German adults | | Zeppelin University | 28/10/2021 | 20211028 | ISRCTN | https://www.isrctn.com/ISRCTN59503725 | Recruiting | No | | | Both | 05/11/2021→10/11/2021 | 41881 | Interventional | Single-center interventional two-stage (individual-and-cluster level) randomized trial (Prevention) | Not Applicable | Germany | Florian | Keppeler |
Zeppelin University
Fallenbrunnen 3
| florian.keppeler@zu.de | +49 (0)7541 6009 1442 | | Inclusion criteria: <br> 1. Residents of the city of Ravensburg<br> 2. Aged 18 years or older<br> | Exclusion criteria: <br> 1. The inmates of the local prison (the city’s largest address cluster)<br> 2. Residents of the cities’ second-largest address cluster (with 75 residents)<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> The study will be conducted in the city of Ravensburg, Germany. All residents of the city (age 18 years and older) will be subject to the trial. Treatment assignment follows a two-stage randomization process. In the first stage, all housing addresses within the city will be randomized into two groups (i.e., intervention group and control group). In the second stage, one resident of each address in both groups will be randomly selected (a "cluster representative"). The cluster representatives in the intervention group only will be sent the intervention letter. All remaining residents will be sent the control letter.<br><br> The treatment group will receive a letter from the mayor of the city inviting them to get a COVID-19 vaccination at one of seven public vaccination events. The letter offers two financial incentives. If the recipient is not already vaccinated and gets vaccinated at the vaccination events, they will receive 20 Euros (in the form of a shopping voucher). Additionally, another 20 Euro incentive is offered if more than 750 city residents get vaccinated at one of the seven vaccination events. If the recipient is already vaccinated, they can still get the second incentive if they give the treatment letter to someone else and that individual brings it to one of the seven vaccination events, gets vaccinated, and more than 750 city residents get vaccinated during the one of the seven vaccination events.<br><br> The control group will get the same letter as the treatment group but without the offer of monetary incentives.<br><br> For the analysis, all residents living at the same address will be treated as members of the same social network. The researchers will test an alternative operationalization of a social networ→<br> Current intervention as of 04/11/2021:<br> The study will be conducted in the city of Ravensburg, Germany. All residents of the city (age 18 years and older) will be subject to the trial. Treatment assignment follows a two-stage randomization process. In the first stage, all housing addresses within the city will be randomized into two groups (i.e., intervention group and control group). In the second stage, one resident of each address in both groups will be randomly selected (a "cluster representative"). The cluster representatives in the intervention group only will be sent the intervention letter. All remaining residents will be sent the control letter.<br><br> The treatment group will receive a letter from the mayor of the city inviting them to get a COVID-19 vaccination at one of seven public vaccination events. The letter offers two financial incentives. If the recipient is not already vaccinated and gets vaccinated at the vaccination events, they will receive 20 Euros (in the form of a shopping voucher). Additionally, another 20 Euro incentive is offered if more than 900 city residents get vaccinated at one of the seven vaccination events. If the recipient is already vaccinated, they can still get the second incentive if they give the treatment letter to someone else and that individual brings it to one of the seven vaccination events, gets vaccinated, and more than 900 city residents get vaccinated during the one of the seven vaccination events.<br><br> The control group will get the same letter as the treatment group but without the offer of monetary incentives.<br><br> For the analysis, all residents living at the same address will be treated as members of the same social network. The researchers will te | <br> 1. Information uptake measured by whether a participant visits the informational website mentioned in the letter. The website is prominently displayed in both treatment and control letters. Each URL is unique to the individual recipient. Measured using server logs for the provided unique links from 05/11/2021 to 13/12/2021.<br> 2. Vaccination uptake measured via an on-site record of administered vaccinations during the seven public vaccination events at 13/11/2021, 19/11/2021, 20/11/2021, 26/11/2021, 27/11/2021, 10/12/2021, and 11/12/2021<br> | | 13/12/2021 | | Yes | False | | |
| → | ISRCTN38746119 | 18 October 2021→15 November 2021 | Long COVID optimal health program (LC-OHP) | Long COVID Optimal Health Program (LC-OHP) to enhance psychological and physical health: a feasibility randomised controlled trial | | University of Suffolk | 08/10/2021 | 20211008 | ISRCTN | https://www.isrctn.com/ISRCTN38746119 | Recruiting | No | | | Both | 15/11/2021 | 60 | Interventional | Pilot single blinded randomized controlled trial (Quality of life) | Not Applicable | England;United Kingdom→United Kingdom;England | | | | | | | Inclusion criteria: <br> 1. Adult (18+ years with no upper age limit).<br> 2. COVID-19 infection confirmed through PCR testing or clinical diagnosis from GP.<br> 3. Experiencing post-COVID-19 syndrome (as defined by NICE 2020) 12 weeks or more following onset of symptoms / confirmed through testing.<br> 4. Able to participate in telephone interview in English language (or with accommodated adjustments).<br> 5. Able to consent to participate in study.<br> | Exclusion criteria: <br> 1. Children and young adults (17 years and under).<br> 2. Unable to consent to participate in study, despite reasonable adjustments being implemented.<br> 3. Unable to participate in telephone interview in English language, where the research team have been unable to make adjustments to enable their participation.<br> | Patients with long COVID <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> Randomisation:<br> Participants will be randomised following the receipt of baseline data to either intervention or control group via a computer-generated block randomization. To avoid bias, an independent person will carry out participant randomisation. Due to the nature and length of the intervention, it is not possible to blind either the researcher nor the participant to the treatment allocation.<br><br> Control group: Standard care<br> Participants allocated to the control group will receive that care usually provided to patients with long COVID. No fixed standard care is yet available and patients are managed symptomatically while following NICE guidelines.<br><br> Intervention group: LC-OHP<br> The long COVID OHP will be provided to participants allocated in the intervention group after the receipt of their baseline data. The OHP is a person-centred model and focuses on health as defined by consumers. It aims to support people with mental or physical illness by using a multidisciplinary collaborative therapy and self-efficacy intervention. The program addresses psychological and physical dimensions of health and is flexible to be delivered by a range of practitioners. It can also be delivered at all stages of the care trajectory; in inpatient and outpatient settings, at homes, or by video conferencing, and to groups or to individuals consumers.<br><br> In this trial, recognising that fatigue is a core component, the OHP for long COVID will be delivered in five sequential sessions. The program’s key elements include goal setting, problem solving, identifying social supports and developing plans to cope with daily stressors, and responding to an episode of illness<br><br> Deliv | <br> Feasibility and acceptability measured by:<br> 1. Recruitment and retention rates measured by identifying the number of participants taking part in the study (from start to end) and number of participants who withdraw from the study at any point.<br> 2. Acceptability and satisfaction of the LC-OHP measured by:<br> 2.1. Conducting a telephone interview with a sample of participants in the intervention group at the end of the trial<br> 2.2. Asking participants in the intervention group to complete the Course Experience Questionnaire (CEQ) at the end of the trial<br> Participants who decide to withdraw from the trial will also be invited to a short interview to assess their views of the LC-OHP and any changes that they may wish to suggest. Interviews will be held as soon after they withdraw<br> 3. Acceptability of secondary outcome measures measured using telephone interview with a sample of participants in the intervention group at the end of the trial<br> | | 31/10/2022 | | Yes | False | | |
| → | ISRCTN12623577 | 26 October 2021→15 November 2021 | PEER CONNECT: peer coaching for long term conditions | A single site feasibility two arm randomised controlled trial of peer coaching for adults with long term conditions: the PEER CONNECT study | | Torbay and South Devon NHS Foundation Trust | 31/08/2021 | 20210831 | ISRCTN | https://www.isrctn.com/ISRCTN12623577 | Recruiting | No | | | Both | 23/11/2021 | 91 | Interventional | Single centre two arm feasibility randomised controlled trial (Other) | Not Applicable | United Kingdom;England→England;United Kingdom | Rachel | Dennett |
Personalised care team, TSDFT
St Edmunds
Victoria Park Road
| rachel.dennett@plymouth.ac.uk | +44 (0)7766 363154 | | Inclusion criteria: <br> 1. Aged 18 years or older (peers and volunteer coaches)<br> 2. Attendance at one of three outpatient clinics (rheumatology, pain and multiple sclerosis) in TSDFT (peers and volunteer coaches)<br> 3. PAM Level 1 or 2 (peers), PAM 3 or 4 (volunteer coaches)<br> 4. Willing and able to engage in the six-month intervention (peers and volunteer coaches)<br> 5. Willing and able to commit to undertaking assessments at baseline, six and nine months (peers).<br> 6. Capacity to provide informed consent (peers and volunteer coaches)<br> 7. Sufficient fluency in English to be able to engage with the intervention and study material (peers and volunteer coaches)<br> | Exclusion criteria: <br> 1. Aged under 18 years<br> 2. Potential peers scoring PAM 3 or 4<br> 3. Potential volunteer coaches scoring PAM 1 or 2<br> 4. Participation in another observational/ interventional research trial<br> 5. Not able to commit to six-month intervention period<br> 6. Not able to provide informed consent<br> 7. Insufficient fluency in English to engage with intervention/ study material<br> | People with long-term conditions attending pain, rheumatology and multiple sclerosis clinics. <br>Not Applicable | Participants who are eligible and consent to receive coaching from volunteer peer coaches will be randomly allocated 1:1 ratio using random permuted blocks, stratified by outpatient clinic (pain, multiple sclerosis, or rheumatology) to receive either coaching and usual care or usual care alone. Participants will receive up to 14 peer coached session provided in a COVID-19 secure environment either on-line, by telephone or face-to-face (if safe to do so). A range of self reported outcome measures will be collected at baseline, post intervention (six months) and three months after the intervention finishes (nine months). | <br> 1. Feasibility outcomes:<br> 1.1. Peer recruitment rate (%) = number of peers recruited/ potentially eligible cohort (indicated by the number of information packs sent or handed out) x100<br> 1.2. Coach recruitment rate (%) = number of volunteer coaches recruited/ potentially eligible cohort (indicated by the number of information packs sent or handed out) x100<br> 1.3. Retention rates will be calculated as the proportion of peers completing all questionnaires at 6 months i.e. the end of the coaching intervention. Follow-up rates will be calculated as the proportion of peers completing all questionnaires at 9 months. 1.4. Coach retention will be calculated as the proportion of coaches who complete the training programme and coaching of (at least) one peer<br> | | 19/04/2023 | | Yes | False | | |
| → | ISRCTN14391248 | 30 August 2021→15 November 2021 | Combining influenza and COVID-19 vaccination (ComFluCOV) study | A single-blind, phase IV UK multi-centre randomised controlled trial to determine reactogenicity and immunogenicity of COVID-19 vaccines administered concomitantly with seasonal influenza vaccines | | University Hospitals Bristol NHS Foundation Trust | 30/03/2021 | 20210330 | ISRCTN | https://www.isrctn.com/ISRCTN14391248 | Not Recruiting | No | | | Both | 29/03/2021 | 756 | Interventional | Multicentre triple-blind parallel-group randomized placebo-controlled trial (Prevention) | Phase IV | United Kingdom→United Kingdom;England;Wales | Rajeka | Lazarus | University Hospitals Bristol and Weston NHS Foundation Trust | rajeka.lazarus@uhbw.nhs.uk | +44 (0)1173423151 | | Inclusion criteria: <br> 1. Aged =18 years<br> 2. Received one dose of either:<br> 2.1. ChAdOx1 vaccine, 56 to 90 days prior to trial enrolment<br> 2.2. BNT162b2 vaccine, 28 and 90 days prior to trial enrolment<br> 3. Agree to refrain from blood donation in the 7 days following vaccination (at both visits 1 and 2)<br> 4. Willing to allow their General Practitioner (GP) and consultant, if appropriate, to be notified of participation in the trial<br> 5. Willing to allow investigators to discuss their medical history and confirm vaccination status with their GP, and access all medical records when relevant to trial procedures<br> 6. Willing and able to give written informed consent for participation in the trial<br> 7. Able to use and has access to an electronic device (such as a laptop, tablet, or smartphone) to complete trial procedures (such as the e-diary)<br> 8. Able and willing to comply with all trial requirements, in the Investigator’s opinion<br> | Exclusion criteria: <br> Current exclusion criteria as of 07/05/2021:<br> 1. Receipt of any vaccine (licensed or investigational) other than ChAdOx1 or BNT162b2 within 30 days before visit 1<br> 2. Administration of immunoglobulins and/or any blood products within three months before visit 1<br> 3. History of allergic disease or reactions likely to be exacerbated by any component of trial vaccines (for example hypersensitivity to the active substance or any of the SmPC-listed ingredients)<br> 4. Bleeding disorder (e.g., factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture and any history of cerebral venous sinus thrombosis, acquired or hereditary thrombophilia, heparin-induced thrombocytopenia or antiphospholipid syndrome. Those who have experienced major venous and arterial thrombosis occurring with thrombocytopenia following vaccination with any COVID-19 vaccine should not receive a second dose of COVID-19 Vaccine AstraZeneca.<br> 5. Continuous use of anticoagulants, such as coumarins and related anticoagulants (such as warfarin) or novel oral anticoagulants (such as apixaban, rivaroxaban, dabigatran, and edoxaban)<br> 6. Suspected or known current alcohol or drug dependency<br> 7. Any other significant disease, disorder, or finding which may significantly increase the risk to the participant, affect their ability to participate in the trial, or impair interpretation of the trial data<br> 8. Current, active, and progressive neurological disorders (such as multiple sclerosis, Guillain-Barre syndrome, transverse myelitis). Bell’s palsy will not be an exclusion criterion<br> 9. Scheduled elective surgery during trial participation if this interferes with the study protocol<br> 10. Participated in another research trial involving an investigational product in the 12 weeks prior to visit 1, or if receipt of any IMP is planned during the trial period<br> 11. Acute, ongoing respiratory illness (moderate or severe illness, with or without fever) at visit 1<br> 12. Fever (oral temperature >37.8°C) at visit 1<br><br> Previous exclusion criteria:<br> 1. Receipt of any vaccine (licensed or investigational) other than ChAdOx1 or BNT162b2 within 30 days before visit 1<br> 2. Administration of immunoglobulins and/or any blood products within three months before visit 1<br> 3. History of allergic disease or reactions likely to be exacerbated by any component of trial vaccines (for example hypersensitivity to the active substance or any of the SmPC-listed ingredients)<br> 4. Bleeding disorder (for example factor deficiency, coagulopathy, or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venepuncture<br> 5. Continuous use of anticoagulants, such as coumarins and related anticoagulants (such as warfarin) or novel oral anticoagulants (such as apixaban, rivaroxaban, dabigatran, and edoxaban)<br> 6. Suspected or known current alcohol or drug dependency<br> 7. Any other significant disease, disorder, or finding which may significantly increase the risk to the participant, affect their ability to participate in the trial, or impair interpretation of the trial data<br> | Adults receiving the influenza (flu) vaccine who may also need COVID-19 booster vaccines <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> Study participants will be randomly allocated to receive one of the following at visit 1 at the same time as their second COVID-19 vaccine (either ChadOx1-nCOV-19 (AstraZeneca/Oxford) vaccine or BNT162b2 (Pfizer BioNTech) vaccine):<br> 1. Investigational Medicinal Product (IMP): Influenza vaccine (Flucelvax QIV if the participant is aged <65 years or FluAd (MF59) if the participant is aged =65 years)<br> 2. Placebo: Sodium chloride 0.9% injection<br><br> Participants, laboratory staff, and clinicians assessing causality will be blinded to the treatment allocation. Randomisation will be performed using a secure internet-based randomisation system ensuring allocation concealment by a member of the local research team. Participants will be allocated in a 1:1 ratio to COVID-19 vaccine plus influenza vaccine or COVID-19 vaccine plus placebo vaccine. The allocation will be computer-generated and will be stratified by age (under 65 years, 65 years or over), type of vaccine (ChAdOx1 or BNT162b2), and centre by an independent BTC CTEU statistician, not involved in the trial, before recruitment begins.<br><br> Approximately 3 weeks later participants will receive the other intervention (participants receiving the influenza vaccine at visit 1 will receive the placebo at visit 2, and participants receiving the placebo at visit 1 will receive the influenza vaccine at visit 2)<br> | 1. Incidence of =1 solicited systemic reaction measured using an electronic diary completed by participants in the 7 days following visit 1. Solicited systemic adverse events include fever, feverishness, chills, joint pains, muscle pains, fatigue, headache, malaise, nausea, vomiting, and diarrhoea. | | 31/08/2021 | | No | False | | |
| → | ISRCTN15328700 | 28 June 2021→15 November 2021 | Developing and evaluating a diabetes self-management intervention for people with severe mental illness | Developing and evaluating a diabetes self-management intervention for people with severe mental illness: The DIAMONDS programme (Diabetes and Mental Illness, Improving Outcomes and Self-management) - Workstream 3 Feasibility Study | | University of York | 12/03/2021 | 20210312 | ISRCTN | http://isrctn.com/ISRCTN15328700→https://www.isrctn.com/ISRCTN15328700 | Recruiting | No | | | Both | 01/07/2021 | 30 | Interventional | Single-group before and after feasibility study with exploratory economic and mixed methods process evaluations (Treatment) | Not Applicable | United Kingdom→United Kingdom;England | Jennifer | Brown |
MHARG, Department of Health Sciences
ARRC Building
University of York
| jennifer.brown@york.ac.uk | +44 (0)1904321661 | | Inclusion criteria: <br> 1. Adults (aged 18 years or older)<br> 2. Severe mental illness (SMI; schizophrenia, bipolar disorder, schizoaffective disorder)<br> 3. Type 2 diabetes (insulin and non-insulin treated)<br><br> The diagnosis of SMI will need to have been made by specialist psychiatric services or general practitioner (GP) and be documented in the patient’s medical records in general practice or secondary care. The diagnosis of diabetes needs to be of at least three months duration and documented in the medical record. Self-reported diabetes will be confirmed by primary care medical records<br> | Exclusion criteria: <br> 1. Cognitive impairments<br> 2. Gestational diabetes<br> 3. Type 1 diabetes<br> 4. Diabetes due to a specific genetic defect or secondary to pancreatitis or endocrine conditions<br> 5. Lack of capacity to participate<br> | Type 2 diabetes in people with severe mental illness <br>Nutritional, Metabolic, Endocrine <br>Type 2 diabetes mellitus | <br> This study will explore the feasibility of the DIAMONDS intervention, a supported diabetes self-management intervention for people with severe mental illness.<br><br> The intervention includes 16 weekly sessions with a trained facilitator ("DIAMONDS Coach") as well as a digital app and a paper-based workbook for participants to work with in between sessions. If possible under COVID-19 restrictions in place at the time, there will also be monthly group sessions for participants.<br><br> Clinical data will be collected at baseline and questionnaires completed. An exploratory process evaluation will be conducted.<br> | <br> 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 5 months<br> 2. Attrition rate recorded as the number of participants who consent to participate that remain in the study until the end of follow up at 4 months<br> 3. Intervention delivery rate recorded as the number of intervention sessions delivered to participants completing the study<br> →<br> Current primary outcome measures as of 04/11/2021:<br> 1. Recruitment rate, measured as the proportion of the recruitment target (n = 30) achieved at 5 months from the start of recruitment<br> 2. Attrition measured as the proportion of missing outcomes data at the end of the recruitment period (5 months from the start of recruitment) for physiological and self-reported data items<br> 3. Intervention delivery rate recorded as the proportion of planned sessions delivered (measured by the number of completed intervention session logs per participant within 15 weeks of the first intervention session)<br><br> Previous primary outcome measures:<br> 1. Recruitment rate recorded as the number of eligible participants who consent to participate in the study by 5 months<br> 2. Attrition rate recorded as the number of participants who consent to participate that remain in the study until the end of follow up at 4 months<br> 3. Intervention delivery rate recorded as the number of intervention sessions delivered to participants completing the study<br> | | 28/02/2022 | | Yes | False | | |
| → | ISRCTN18107122 | 25 January 2021→15 November 2021 | Participatory digital interventions for front-line staff during the coronavirus (COVID-19) pandemic | Using participatory digital platforms to enhance resilience and mental health of Scottish frontline health and care staff during COVID-19 | | NHS Highland | 11/01/2021 | 20210111 | ISRCTN | http://isrctn.com/ISRCTN18107122→https://www.isrctn.com/ISRCTN18107122 | Not Recruiting | No | | | Both | 15/06/2020 | 180 | Interventional | A single centre randomized controlled trial with a cross sectional survey (Quality of life) | Not Applicable | United Kingdom→Scotland;United Kingdom | | | | | | | Inclusion criteria: <br> 1. Aged =18 years<br> 2. Front line health care staff employed by NHS Highland<br> 3. Capacity to give consent<br> | Exclusion criteria: Does not meet inclusion criteria | Mental wellbeing of NHS staff during the COVID-19 pandemic <br>Mental and Behavioural Disorders | <br> The three arms of the pilot RCT were made up of the intervention (The NHS Highland Staff Wellbeing Project), treatment as usual app (MPS), and a control condition (wait list). The NHS Highland Staff Wellbeing Project is a digital platform providing personalised mental health strategies, monitoring of anxiety and mood, and feedback and interactive messaging to support NHS staff in maintaining or improving their mental health during the COVID-19 pandemic. The roll-out of the intervention to the waitlist control group will take place after the RCT. Recruited participants were randomly assigned (1:1:1) to one of the three conditions prior to the RCT.<br><br> From the literature, PPI feedback, and the funding call to provide rapid research into COVID-19, the research team decided to restrict the intervention (and all other conditions) to 4 weeks. The first two weeks of the intervention focused on building resilience and the character strength of gratitude, whilst the last two weeks focused on dealing successfully with low mood and anxiety. The treatment as usual intervention was a generic NHS trusted app designed to support psychological well-being and decrease depression and anxiety.<br><br> All participants were contacted via email and text in preparation of the RCT starting on 7 September. Participants allocated to different conditions will receive different messages via email and text. The treatment as usual and intervention ntervention groups’ emails (from UHI) and texts (automated) were designed to appear very similar (as to blind these participants from knowing which app they will be receiving). The control group received an email (from UHI) & text message (from MPS) stating that they are on the waiting list and that they will receiv | <br> 1. Psychological changes:<br> 1.1. Anxiety symptoms and depressive symptoms measured using the Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder Assessment (GAD-7) at baseline, 2, and 4 weeks<br> 1.2. Psychological well-being and mental toughness measured using the Edinburgh Well-being Scale (WEWBS) and Mental Toughness Index (MTI) at baseline, 2, and 4 weeks<br> →<br> Current primary outcome measure as of 10/11/2021:<br> 1. Psychological changes:<br> 1.1. Anxiety symptoms and depressive symptoms measured using the Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder Assessment (GAD-7) at baseline, 2, and 4 weeks<br> 1.2. Psychological well-being measured using the Edinburgh Well-being Scale (WEWBS) at baseline, 2, and 4 weeks<br><br> Previous primary outcome measure:<br> 1. Psychological changes:<br> 1.1. Anxiety symptoms and depressive symptoms measured using the Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder Assessment (GAD-7) at baseline, 2, and 4 weeks<br> 1.2. Psychological well-being and mental toughness measured using the Edinburgh Well-being Scale (WEWBS) and Mental Toughness Index (MTI) at baseline, 2, and 4 weeks<br> | | 14/10/2020 | | No | False | | |
| → | ISRCTN11946807 | 4 October 2021→15 November 2021 | Characterisation of COVID-19 long-term immunity | Longitudinal study of physiological and immunological responses to COVID-19/SARS-CoV-2 infection in a population based study – Children of the 90s | | University of Bristol | 23/11/2020 | 20201123 | ISRCTN | https://www.isrctn.com/ISRCTN11946807 | Recruiting | No | | | Both | 13/11/2020 | 250 | Observational | Observational; Design type: Cohort study (Screening) | Not Applicable | United Kingdom;England | Melanie | Lewcock |
University of Bristol
Oakfield House
Oakfield Grove
| melanie.lewcock@bristol.ac.uk | +44 (0)1173310127 | | Inclusion criteria: <br> Participants of the ALSPAC cohort meeting the following criteria:<br> 1. Aged 25 or over<br> 2. Undergone SARS-CoV-2 antibody testing through the ALSPAC SARS-CoV-2 serology study (IRAS 289493)<br> 3. Individuals who, through self-report or through linkage to official health records, are identified as being highly likely to have had COVID-19 infection (from either positive SARS-CoV-2 PCR test performed at NHS care facility, COVID-19 testing site or home testing)<br> 4. Individuals who have been told by a physician that, in the opinion of that doctor, they have had a clinical illness likely to be COVID-19<br><br> Control participants<br> 5. Aged 25 or over<br> 6. Individuals who self-report as not experiencing symptoms of COVID-19 via the symptom survey<br> 7. Self-report as not having had positive SARS-CoV-2 molecular test<br> 8. Are confirmed SARS-CoV-2 seronegative at Visit 1<br> | Exclusion criteria: <br> Exclusion criteria for both controls and cases:<br> 1. Do not wish to participate in this research study<br> 2. Participants taking blood thinners or blood-thinning agents (e.g. warfarin) or with a known clotting disorder or other reason unable to provide a blood sample<br> 3. Not willing to provide blood samples<br> 4. Do not meet eligibility criteria for respective arm<br> | COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations <br>COVID-19 (SARS-CoV-2 infection) | <br> ALSPAC will complete a case selection process to identify participants who are likely to have had a SARS-CoV-2 infection and controls who are unlikely to have had COVID-19. This will involve review of the following information already held by the ALSPAC study:<br> 1. Participants with a positive antibody response as part of serological testing completed by cohort members<br> 2. Review of linked NHS data, where participants have previously consented to linkage<br> 3. Self report of a positive COVID-19 test or GP diagnosis via response to previous questionnaires, or self report of no symptoms or tests.<br><br> All those identified through the case selection (approx. 150 cases and up to 200 controls) will receive an initial invite email. Study information is provided via a link to the Participant Information Sheet. Participants will be asked to respond by phone or email if they wish to take part. They will then be called to book an initial 45 min appointment at the ALSPAC centre, Oakfield House, Bristol. A confirmation letter and link to visit information sheet will be sent. The day before the visit a reminder call will be made and this will include a check for any COVID-19 symptoms. If participants do not respond to the initial invite within 1 week a reminder message will be sent and after a further week on non-response a phone-call reminder.<br><br> At the visit the participant will be asked to complete the following procedures:<br> Informed consent - A 1-1 session with an ALSPAC Fieldworker<br> Blood sampling (4x10ml EDTA, 1x5ml Serum)<br> Saliva sample<br> Physical Measures - Height, weight<br> Respiratory function testing - A 1 minute sit | <br> 1. Presence in saliva of SARS-CoV-2 determined using reverse transcriptase polymerase chain reaction (RT-PCR assay) at baseline, 4 months and 9 months<br> 2. Titres (concentration) of each antibody isotype (e.g. IgM, IgA, IgG) in blood samples specific to SARS-CoV-2 viral proteins/epitopes being produced determined by ELISA and Western blots. At baseline, 4 months and 9 months<br> 3. B and T-cell immune response and characteristics of innate immune cell function by laboratory analysis of blood samples (flow cytometry, ELISpots, ELISA) at baseline, 4 months and 9 months<br> 4. Immune response to COVID-19 and cross-reactive immune responses against other pathogens such as the circulating human CoVs by laboratory analysis of blood samples (B-cell receptor (BCR) sequencing, T-cell receptor (TCR) sequencing, NanoString analysis, RNAseq, single cell analysis, transciptomics, proteomics, cell signalling analysis, analysis of cellular cytotoxicity) at baseline, 4 months and 9 months<br> 5. T-Cell, B-cell and antibody cross-reactivity and definition of how cross-reactivity may influence response to infection and/or vaccination by laboratory analysis of blood samples (B-cell receptor (BCR) sequencing, T-cell receptor (TCR) sequencing, NanoString analysis, RNAseq, single cell analysis, transciptomics, proteomics, cell signalling analysis, analysis of cellular cytotoxicity) at baseline, 4 months and 9 months<br> | | 30/11/2021 | | No | False | | |
| → | ISRCTN79623250 | 24 May 2021→15 November 2021 | The digital Hope programme for people living with cancer during COVID-19 | The Help to Overcome Problems Effectively (HOPE) programme for people living with cancer during COVID-19: a feasibility randomised waitlist controlled trial | | Coventry University | 04/11/2020 | 20201104 | ISRCTN | http://isrctn.com/ISRCTN79623250→https://www.isrctn.com/ISRCTN79623250 | Not Recruiting | No | | | Both | 30/04/2020 | 40 | Interventional | Feasibility 1:1 randomized waitlist controlled trial (Other) | Not Applicable | United Kingdom→United Kingdom;England | Hayley | Wright |
Centre for Intelligent Healthcare
Faculty of Health and Life Sciences
Coventry University
Priory Street
| ab7764@coventry.ac.uk | +44 (0)7904118985 | | Inclusion criteria: <br> 1. Diagnosis of any type of cancer, at any stage<br> 2. Adult (18 years or over)<br> 3. Located in the United Kingdom<br> 4. Access to the internet and a device that will allow them to engage with the intervention<br> 5. Fluent in English to be able to engage with all the material in the intervention<br> 6. Not recruited via the NHS<br> | Exclusion criteria: Does not meet inclusion criteria | Self-management for people with cancer <br>Cancer | <br> This study will employ a feasibility, randomised wait-list control group design, to explore the feasibility of a trial of the digital Hope Programme for PWC.<br><br> Randomisation is via Qualtrics survey platform, following completion of consent and baseline questionnaires.<br><br> The intervention is a six-week digital self-management programme.<br><br> Quantitative monitoring of participant progress through the online programme will be undertaken. Participants will be asked to complete standardised measures of depression, anxiety, mental wellbeing and confidence in managing their cancer.<br> | <br> Feasibility outcome measures<br> 1. Recruitment rates for participation and randomisation will be collected through Qualtrics. All eligible participants identified by MCS will be sent a link to the Qualtrics study survey, so we will calculate recruitment rates from those providing consent and/or completing baseline questionnaires<br> 2. Retention and follow-up rates. Follow up will be online. Participants who become lost to follow up will be identified through Qualtrics as those not completing post programme questionnaires. It is possible that these participants may still complete some or all of the Hope programme, and so participant retention can be identified separately through engagement with the Hope platform. Participants who explicitly request to be withdrawn from the study will be categorized accordingly, but we will not contact participants to obtain reasons for not completing questionnaires.<br> 3. Adherence rates. The Hope platform collects user engagement data such as login frequency and duration, which assists the moderators with participant engagement and experience. Participants also have the option of receiving system generated automatic nudge reminders sent to their email address. We will analyse this user engagement data to generate usage patterns and provide an overview of session attendance and participant engagement.<br> 4. Sample size and effect size estimation. To inform sample size estimation for a future definitive trial, we will calculate the standard deviations of the continuous secondary outcomes pertaining to depression, anxiety, mental wellbeing and confidence to manage their cancer. To estimate potential effect sizes for a primary outcome in a future definitive trial, namely change in scores on key secondary outcome measures from pre- to post programme, we will calculate the difference between the mean difference pre and post programme for the intervention and control groups and divide by the pooled standard deviation at baseline<br><br> 5. Progression criteria<br> We will collate the data from all participants in this feasibility RCT to inform progression to a definitive trial (all measured using the Hope platform):<br> 5.1. Recruitment rate<br> 5.2. Questionnaire completion rate<br> 5.3. Programme completion rate<br> | | 02/09/2020 | | No | False | | |
| → | ISRCTN12890382 | 10 May 2021→15 November 2021 | Child anxiety treatment in the context of COVID-19 | Child Anxiety Treatment in the context of COVID-19 (Co-CAT): Enabling Child and Adolescent Mental Health Services (CAMHS) to provide efficient remote treatment for child anxiety problems | | University of Oxford | 23/10/2020 | 20201023 | ISRCTN | http://isrctn.com/ISRCTN12890382→https://www.isrctn.com/ISRCTN12890382 | Recruiting | No | | | Both | 02/11/2020 | 560 | Interventional | Interventional multi-site two-arm parallel-group randomized controlled non-inferiority trial (Treatment) | Not Applicable | United Kingdom→United Kingdom;England | | | | | | | Inclusion criteria: <br> Child inclusion criteria:<br> 1. Aged 5-12 years at intake<br> 2. Primary problem is anxiety<br> 3. Willing and able to assent<br><br> Parent/Carer inclusion criteria:<br> 1. Has sufficient English language to complete measures/ access interventions<br> 2. Family has access to the internet<br> 3. Is willing and able to provide consent<br> | Exclusion criteria: <br> Child exclusion criteria:<br> 1. The child has co-morbid conditions that are likely to interfere with treatment delivery, (established autism spectrum condition/ learning disability, suicidal intent/ recurrent or potentially life-limiting self-harm)<br> 2. The child is identified by social services due to child protection concerns<br><br> Parent/Carer exclusion criteria:<br> 1. The parent has a significant intellectual impairment or severe mental health problem that is likely to interfere with treatment delivery<br> 2. The parents are unable to access or understand the written English language materials necessary for the interventions<br> | Anxiety problems in children aged 5-12 <br>Mental and Behavioural Disorders | <br> Intervention(s)<br> Online psychological intervention for child anxiety with therapist support (OSI+therapist support). OSI is an online platform for sharing content and record keeping as part of a brief therapist-supported parent-led cognitive behavioural treatment (CBT). The seven modules are completed by the parent over seven weeks, supported by 7 weekly 20 minute telephone sessions between the parent/carer and a therapist and a review session 4 weeks after the final treatment session.<br><br> Comparator<br> Treatment as usual for children with anxiety in clinical Child and Adolescent Mental Health Services in the COVID-19 context (C-TAU). The exact nature of this will depend on what the usual treatments are within each service.<br><br> For both treatment arms (intervention and comparator), there is an online follow up assessment at 14 and 26 weeks after randomisation.<br><br> Therapists will introduce and provide access to information about the study to eligible families. Participants will be automatically randomised to receive either the OSI+therapist support intervention or the comparator after consenting online and completing some baseline measures online. Treatment allocation will be communicated to the participant and their therapist via email.<br> | Child Anxiety is measured using a parent self-report questionnaire (The Child Anxiety Impact Scale-parent report, CAIS-P) at baseline, 14 weeks, and 26 weeks. | | 30/05/2022→31/03/2023 | | Yes | False | | |
| +++ | ISRCTN11952463 | 15 November 2021 | What’s the STORY: serum testing of representative youngsters including SARS-CoV-2 (COVID-19), diphtheria and meningitis C | Sero-epidemiological survey of England in 2019/2020 | | University of Oxford | 01/06/2020 | 20200601 | ISRCTN | https://www.isrctn.com/ISRCTN11952463 | Recruiting | No | | | Both | 15/10/2019 | 3800 | Observational | Prospective cross-sectional seroprevalence study (Screening) | Not Applicable | England;United Kingdom | | | | | | | Inclusion criteria: <br> Current inclusion criteria as of 18/12/2020:<br><br> 1. Parents/legal guardians or adult participant is willing and able to give informed consent for participation in the study<br> 2. Male or Female, aged 0 - 24 years inclusive (Group 1) and 0 - 19 inclusive (Group 2 and 3)<br> 3. Parents/legal guardians or adult participants are willing to allow their General Practitioner or relevant NHS databases to be contacted for a full immunisation history<br><br> _____<br><br> Previous inclusion criteria:<br><br> 1. Parents/legal guardians or adult participant* is willing and able to give informed consent for participation in the study.<br> 2. Male or female, aged 0 - 24 years inclusive (Group 1)<br> 3. Male or female, aged 0 - 19 years inclusive (Group 2)<br> 4. Parents/legal guardians or adult participants are willing to allow their General Practitioner or relevant NHS databases to be contacted for a full immunisation history<br> | Exclusion criteria: <br> Current exclusion criteria as of 18/12/2020:<br><br> 1. Group 1 only If participants do not live in the postcode districts selected by PHE (Group 1 only)<br> 2. Group 3 only if participants are not from the BAME population<br> 3. Participants who have a member of their household already enrolled in the study where their ages are less than 5 years apart<br> 4. Any significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the research study, or may influence the result of the research study, or the participant’s ability to participate in the research study. Examples of disorders or diseases which would be excluded include:<br> 4.1. Medically diagnosed bleeding disorder<br> 4.2. Medically diagnosed platelet disorder<br> 4.3. Anticoagulant medication<br> 4.4. Pregnancy<br><br> Temporary exclusion criteria:<br> The participant may not enter the study if they or any member of their household is under temporary isolation measures for suspected SARS-CoV-2 infection<br><br> _____<br><br> Previous exclusion criteria:<br><br> If participants do not live in the postcode districts selected by PHE (Group 1 only)<br> 1. Medically diagnosed bleeding disorder<br> 2. Medically diagnosed platelet disorder<br> 3. Anticoagulation medication<br> 4. Pregnancy<br> 5. If another member of their household is participating who is within 5 years of age of the potential participant's age<br><br> Temporary exclusion criteria:<br> The participant may not enter the study if they or any member of their household is under temporary isolation measures for suspected SARS-CoV-2 infection.<br> | Diphtheria, group C meningococcus infection, COVID-19 (SARS-CoV-2 infection) <br>Infections and Infestations | <br> This is a pilot study to assess the feasibility of establishing a national seroepidemiological survey in England in individuals aged 0-24 years, focusing initially on diphtheria and group C invasive meningococcal disease. The researchers are aiming to recruit 2300 individuals and are aiming to ensure that sample is broadly representative of the region according to IMD (Index of Multiple Deprivation scores). The PHE generated a list of all postcodes in recruiting regions and determining the quintiles of IMD within that region. Participants interested in taking part in the study will contact sites to arrange a visit. Basic demographic characteristics will be collected by questionnaire and/ or case report form (CRF) and will include: DOB, gender, GP details, ethnic group, association with communities of special interest, household income and vaccination history.<br><br> Randomised selection of population - Group 1<br> Group 1 will be focusing on COVID-19, diphtheria and group C invasive meningococcal disease. The investigators are aiming to recruit around 2300 individuals and the investigators are aiming to ensure that sample is broadly representative of the region according to IMD (Index of Multiple Deprivation scores). PHE has generated a list of all postcodes in recruiting regions and determining the quintiles of IMD within that region. Participants interested in taking part in the study will contact sites to arrange a visit. Basic demographic characteristics will be collected by questionnaire and/ or case report form (CRF) and will include: DOB, gender, GP details, ethnic group, association with communities of special interest, household income and vaccination history.<br><br> Group 2<br> Group 2 will focus on | <br> 1. Feasibility of a population-based seroepidemiological programme measured by response rate and participation in the study as proved by questionnaire completion, sample collection and database records at baseline<br> 2. Added public health benefit measured by comparison with serological markers of immunity for vaccine-preventable diseases as measured in an age-matched cohort in the current residual sera programme which will occur at the end of the study<br> | | 30/06/2022 | | No | False | | |
| +++ | ChiCTR2100052725 | 16 November 2021 | Analysis of the composition and influencing factors of the major pathogens of community-acquired pneumonia during the crown epidemic | Analysis of the composition and influencing factors of the major pathogens of community-acquired pneumonia during the crown epidemic | | Emergency center of Affiliated Hospital of Xuzhou Medical University | 2021-11-04 | 20211104 | ChiCTR | http://www.chictr.org.cn/showproj.aspx?proj=136712 | Recruiting | No | 1 | 100 | Both | 2021-11-05 | pre-COVID-19 group:2700;post-COVID-19 group:654; | Observational study | Factorial | Retrospective study | China | Ye Ying | | 99 Huaihai Road West, Quanshan District, Xuzhou, Jiangsu, China | xzmcyy@163.com | +86 18052268313 | Emergency center of Affiliated Hospital of Xuzhou Medical University | Inclusion criteria: The criteria for the diagnosis and treatment of community-acquired pneumonia in adults were met in the China Guideline for the diagnosis and treatment of community-acquired pneumonia in adults (2016 version) and the publication of the code for the diagnosis and treatment of community-acquired pneumonia in children (2019 version). | Exclusion criteria: 1. Comorbid chronic respiratory diseases such as cystic fibromatosis;
<br>2. With underlying diseases such as foreign body aspiration pneumonia, hypersensitivity pneumonia, obstructive pneumonia, active tuberculosis, or the presence of bronchiectasis. | Community-acquired pneumonia | pre-COVID-19 group:no;post-COVID-19 group:no; | Pathogens; | | | | Yes | False | | |
| → | EUCTR2021-000623-13-AT | 2 August 2021→15 November 2021 | A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patients | A Phase 3 randomized, multi-center, open label study to assess the efficacy, safety, and tolerability of monoclonal antibody VIR-7831 (sotrovimab) given intramuscularly versus intravenously for the treatment of mild/moderate coronavirus disease 2019 (COVID-19) in high-risk non-hospitalized patients - Intramuscular VIR-7831 (sotrovimab) for mild/moderate COVID-19 Study Phase: Phase III | | Vir Biotechnology, Inc. | 02/07/2021 | 20210702 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000623-13 | Not Available→Not Recruiting | No | | | <br>Female: yes<br>Male: yes<br> | | 1020 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: yes<br>Other specify the comparator: Two dose levels of intramuscular VIR-7831 are compared versus one dose of intravenous VIR-7831<br>Number of treatment arms in the trial: 3<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Moldova, Republic of;South Africa;Peru;Romania;Poland;Brazil;Argentina;Canada;France;India;Italy;Austria;Ukraine;Spain;United States | Carla Cafè | | Segreen Business Park, Palazzo Y, via san Bovio 3 | carla.cafe@ppd.com | +3902210811 | Pharmaceutical Product Development -PPD | Inclusion criteria: <br>AGE AND RISK FACTORS<br>1. Participant must be aged 12 years or older at time of consent AND at high risk of progression of COVID-19 based on the presence of one or more of the following risk factors:<br> a. For 12-17 years old: diabetes, obesity (BMI =85th percentile for age/gender based on CDC growth charts), chronic kidney disease (e.g. eGFR <60), sicklecell disease, congenital heart disease, neurodevelopmental disorders, chronic lung diseases (i.e. chronic obstructive pulmonary disease, moderate to severe asthma requiring steroids, interstitial lung disease, cystic fibrosis, and pulmonary hypertension), immunosuppressive disease or immunosuppressive medications, or chronic liver disease<br> b. For 18-54 years old: diabetes (requiring medication), obesity (BMI = 30, chronic kidney disease (i.e., eGFR <60 by MDRD), congenital heart disease, congestive heart failure (NYHA class II or more), chronic lung diseases (i.e. chronic obstructive pulmonary disease, moderate to severe asthma requiring steroids, interstitial lung disease, cystic fibrosis, and pulmonary hypertension), sickle cell disease, neurodevelopmental disorders, immunosuppressive disease or receiving immunosuppressive medications, or chronic liver disease<br>OR<br>2. Participant = 55 years old, irrespective of co-morbidities<br><br>TYPE OF PARTICIPANT AND DISEASE CHARACTERISTICS<br>3. Participants who have a positive SARS-CoV-2 test result within 7 days of randomization (by any validated diagnostic test e.g. RT-PCR, antigen based testing on any specimen type)<br>AND<br>4. Oxygen saturation =94% on room air<br>AND<br>5. Have symptoms of COVID-19 defined by one or more of the following: fever, chills, cough, sore throat, malaise, headache, joint or muscle pain, change in smell or taste, vomiting, diarrhea, shortness of breath on exertion<br>AND<br>6. Participant to be dosed less than or equal to 7 days from onset of symptoms to dosing day (D1)<br><br>SEX AND CONTRACEPTIVE/BARRIER REQUIREMENTS<br>7. No gender restrictions<br>8. Female participants must meet and agree to abide by the following contraceptive criteria. Contraception use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.<br>A female participant is eligible to participate if she is not pregnant or breastfeeding, and one of the following conditions applies:<br> a. Is a woman of non-childbearing potential (WONCBP).<br>OR<br> b. Is a WOCBP and using a contraceptive method that is highly effective, with a failure rate of <1%, during the study intervention period and for up to 24 weeks after the last dose of study intervention.<br>The investigator should evaluate potential for contraceptive method failure (e.g., noncompliance, recently initiated) in relationship to the first dose of study intervention.<br>A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) before the first dose of study intervention.<br> -If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the<br>participant must be excluded from participation if the serum pregnancy result is positive.<br><br>INFORMED CONSENT<br>9. Capable of giving signed informed consent.<br>OR<br>10. If participants are not capable of giving written informed consent, alternative consent procedures will be followed as defined in Section 10.1.3 of protocol.<br>OR<br>11. Participants <18 years old will be required to sign an assent form in addition to a par | Exclusion criteria: <br>MEDICAL CONDITIONS<br>1. Currently hospitalized or judged by the investigator as likely to require hospitalization in the next 24 hours<br>2. Symptoms consistent with severe COVID-19 as defined by shortness of breath at rest or respiratory distress or requiring supplemental oxygen<br>3. Participants who, in the judgement of the investigator are likely to die in the next 7 days.<br>4. Known hypersensitivity to any constituent present in the investigational product<br><br>PRIOR/CONCURRENT CLINICAL STUDY EXPERIENCE<br>5. Enrollment in any investigational vaccine study within the last 180 days or any other investigational drug study within 30 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer<br>6. Enrollment in any trial of an investigational drug, vaccine or device study for SARS-CoV-2/COVID-19 within 90 days prior to Day 1 or within 5 half-lives of the investigational compound, whichever is longer<br><br>OTHER EXCLUSIONS<br>7. Receipt of convalescent plasma from a recovered COVID-19 patient or anti SARS-CoV-2 mAb within the last 3 months.<br>8. Participants who, in the judgment of the investigator, will be unlikely or unable to comply with the requirements of the protocol through Day 29<br>NOTE: Previous receipt of a SARS-CoV-2/COVID-19 vaccine is NOT an exclusion criteria<br> | Mild/moderate COVID-19 <br>MedDRA version: 23.0
Level: PT
Classification code 10084268
Term: COVID-19
System Organ Class: 10021881 - Infections and infestations
<br>MedDRA version: 23.1
Level: LLT
Classification code 10084401
Term: COVID-19 respiratory infection
System Organ Class: 10021881 - Infections and infestations
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Code: VIR-7831<br>Pharmaceutical Form: Solution for injection/infusion<br>INN or Proposed INN: Sotrovimab<br>CAS Number: 2423014-07-5<br>Current Sponsor code: VIR-7831 (GSK4182136) or WBP2275<br>Other descriptive name: VIR-7831<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 62.5-<br><br>Product Code: VIR-7831<br>Pharmaceutical Form: Solution for injection/infusion<br>INN or Proposed INN: Sotrovimab<br>CAS Number: 2423014-07-5<br>Current Sponsor code: VIR-7831 (GSK4182136) or WBP2275<br>Other descriptive name: VIR-7831<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 62.5-<br><br>Product Code: VIR-7831<br>Pharmaceutical Form: Solution for injection/infusion<br>INN or Proposed INN: Sotrovimab<br>CAS Number: 2423014-07-5<br>Current Sponsor code: VIR-7831 (GSK4182136) or WBP2275<br>Other descriptive name: VIR-7831<br>Concentration unit: mg/ml milligram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 62.5-<br><br> | Timepoint(s) of evaluation of this end point: Day 29;Primary end point(s): Progression of COVID-19 through Day 29 as defined by hospitalization > 24 hours for acute management of illness due to any cause or death.;Secondary Objective: 1-Describe safety and tolerability of IM and IV VIR-7831<br>2-Assess VIR-7831 immunogenicity<br>3-Evaluate two dose levels efficacy of IM vs IV VIR-7831 on mild/moderate COVID-19 progression<br>4-Evaluate two dose levels efficacy of IM vs IV VIR-7831 in preventing COVID-19 respiratory disease progression<br>5-Compare VIR-7831 virologic activity given IM (two dose leves) or IV in reducing SARS-CoV-2 viral load<br>6-Assess VIR-7831 pharmacokinetics in serum following IV and IM administration<br>7-Describe effect of two dose levels of IM vs IV VIR-7831 on incidence and duration of time on total hospital length of stay, incidence and duration of time on a ventilator, and ICU length of stay<br>8-Monitor SARS-CoV-2 resistant mutants against VIR-7831<br>9-Compare VIR-7831 virologic activity given IM (two dose leves) or IV in reducing SARS-CoV-2 viral load<br>10-Compare effect of different sample collection methods in SARS-CoV-2 viral load<br>11-Evaluate VIR-7831 effect on the development of SARS-CoV-2 antibodies;Main Objective: Evaluate the efficacy of two dose levels of intramuscular (IM) VIR-7831 versus (vs) intravenous (IV) VIR-7831 in preventing the progression of mild/moderate COVID-19→Timepoint(s) of evaluation of this end point: Day 29;Primary end point(s): Progression of COVID-19 through Day 29 as defined by hospitalization > 24 hours for acute management of illness due to any cause or death.;Main Objective: Evaluate the efficacy of two dose levels of intramuscular (IM) VIR-7831 versus (vs) intravenous (IV) VIR-7831 in preventing the progression of mild/moderate COVID-19;Secondary Objective: 1-Describe safety and tolerability of IM and IV VIR-7831<br>2-Assess VIR-7831 immunogenicity<br>3-Evaluate two dose levels efficacy of IM vs IV VIR-7831 on mild/moderate COVID-19 progression<br>4-Evaluate two dose levels efficacy of IM vs IV VIR-7831 in preventing COVID-19 respiratory disease progression<br>5-Compare VIR-7831 virologic activity given IM (two dose leves) or IV in reducing SARS-CoV-2 viral load<br>6-Assess VIR-7831 pharmacokinetics in serum following IV and IM administration<br>7-Describe effect of two dose levels of IM vs IV VIR-7831 on incidence and duration of time on total hospital length of stay, incidence and duration of time on a ventilator, and ICU length of stay<br>8-Monitor SARS-CoV-2 resistant mutants against VIR-7831<br>9-Compare VIR-7831 virologic activity given IM (two dose leves) or IV in reducing SARS-CoV-2 viral load<br>10-Compare effect of different sample collection methods in SARS-CoV-2 viral load<br>11-Evaluate VIR-7831 effect on the development of SARS-CoV-2 antibodies | | | | Yes | False | | |
| → | EUCTR2020-005366-34-IE | 2 August 2021→15 November 2021 | A Study to Evaluate the Antiviral Activity, Safety, Pharmacokinetics, and Efficacy of RO7496998 (AT-527) in Non-Hospitalized Adult Patients with Mild or Moderate COVID-19 | A PHASE II RANDOMIZED, DOUBLE-BLIND,
PLACEBO-CONTROLLED STUDY TO EVALUATE
THE ANTIVIRAL ACTIVITY, SAFETY,
PHARMACOKINETICS, AND EFFICACY OF
RO7496998 (AT-527) IN
NON-HOSPITALIZED ADULT PATIENTS WITH
MILD OR MODERATE COVID-19 - Phase II virology covid study | | F. Hoffmann La Roche Ltd. | 21/12/2020 | 20201221 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005366-34 | Authorised→Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 12/02/2021 | 220 | Interventional clinical trial of medicinal product | Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): yes
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): no
| United Kingdom;Latvia;Bulgaria;Croatia;Lithuania;Ireland;Poland;Spain;Canada;Greece;United States | Trial Information Support Line-TISL | | Grenzacherstrasse 124 | global.rochegenentechtrials@roche.com | | F.Hoffmann-La Roche, Ltd. | Inclusion criteria: <br>Age>=18 years at time of signing Informed Consent Form<br>Positive SARS-CoV-2 diagnostic test (RT-PCR or rapid antigen test) at screening<br>Has symptoms consistent with mild or moderate COVID-19, as determined by the investigator, with onset <=5 days prior to randomization<br>For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception, during the treatment period and for 30 days after the final dose of study drug. <br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 198<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 22<br> | Exclusion criteria: <br>Clinical signs indicative of COVID-19 illness requiring hospitalization, defined as any of the following: shortness of breath at rest, respiratory rate >= 30, heart rate >= 125, peripheral capillary oxygen saturation (SpO2) <= 93% on room air<br>Treatment with a therapeutic agent against SARS-CoV-2 including, but not limited to, other direct-acting antivirals, convalescent plasma, monoclonal antibodies against SARS-CoV-2, or intravenous immunoglobulin within 3 months or less than 5 drug-elimination half-lives (whichever is longer) prior to screening<br>Requirement, in the opinion of the investigator, for any of the prohibited medications during the study<br>Use of hydroxychloroquine or amiodarone within 3 months of screening<br>Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of study drug. Women of childbearing potential must have a negative serum pregnancy test result at screening<br>Abnormal laboratory test results at screening<br>Clinically significant abnormal ECG, as determined by the Investigator, at screening<br>Planned procedure or surgery during the study<br>Known allergy or hypersensitivity to study drug or drug product excipients<br>Substance abuse, as determined by the investigator, within 12 months prior to screening<br>Poor peripheral venous access<br>Malabsorption syndrome or other condition that would interfere with enteral absorption<br>Any clinically significant history of epistaxis within the last 3 months and/or history of being hospitalized due to epistaxis of any previous occasion <br>History of anaphylaxis<br>Any uncontrolled serious medical condition or other clinically significant abnormality in laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study<br><br><br><br> | Coronavirus disease 2019 (COVID-19) <br>MedDRA version: 23.1
Level: LLT
Classification code 10084401
Term: COVID-19 respiratory infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: AT-527<br>Product Code: RO7496998<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Not available yet<br>CAS Number: 2241337-84-6<br>Current Sponsor code: RO7496998<br>Other descriptive name: AT-511 HEMI-SULFATE SALT<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 550-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br>Product Name: AT-527<br>Product Code: RO7496998<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Not available <br>CAS Number: 2241337-84-6<br>Current Sponsor code: RO7496998<br>Other descriptive name: AT-511 HEMI-SULFATE SALT<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 275-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: 1. Baseline (Day 1) to Day 7;Primary end point(s): Change from baseline in amount of SARS-CoV-2 virus RNA as measured by RT-PCR at specified timepoints;Secondary Objective: • To evaluate the antiviral activity of AT 527 compared with placebo based on time to cessation of SARS-CoV-2 viral shedding, time to sustained non-detectable SARS-CoV-2 virus RNA, proportion of patients positive for SARS-CoV-2 virus RNA, and area under the curve in the amount of SARS-CoV-2 virus RNA<br>• To evaluate the safety of AT 527 compared with placebo<br>• To characterize the PK profile of AT 511 (free base form of AT-527) and its major metabolites<br>• To evaluate the efficacy of AT 527 compared with placebo<br>;Main Objective: • To evaluate the antiviral activity of AT-527 compared with placebo based on change from baseline in amount of SARS-CoV-2 virus RNA→Timepoint(s) of evaluation of this end point: 1. Baseline (Day 1) to Day 7;Primary end point(s): Change from baseline in amount of SARS-CoV-2 virus RNA as measured by RT-PCR at specified timepoints;Main Objective: • To evaluate the antiviral activity of AT-527 compared with placebo based on change from baseline in amount of SARS-CoV-2 virus RNA;Secondary Objective: • To evaluate the antiviral activity of AT 527 compared with placebo based on time to cessation of SARS-CoV-2 viral shedding, time to sustained non-detectable SARS-CoV-2 virus RNA, proportion of patients positive for SARS-CoV-2 virus RNA, and area under the curve in the amount of SARS-CoV-2 virus RNA<br>• To evaluate the safety of AT 527 compared with placebo<br>• To characterize the PK profile of AT 511 (free base form of AT-527) and its major metabolites<br>• To evaluate the efficacy of AT 527 compared with placebo<br> | | | | Yes | True | parent | |
| → | EUCTR2020-005759-18-DE | 30 August 2021→15 November 2021 | A study to evaluate the Efficacy, Safety, and Antiviral Activity of RO7496998 (AT-527) in Patients with Mild or Moderate COVID-19 | A MULTICENTER, PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, OUTPATIENT STUDY TO EVALUATE THE EFFICACY, SAFETY, AND ANTIVIRAL ACTIVITY OF RO7496998 AT-527 IN PATIENTS WITH MILD OR MODERATE COVID-19 | | F. Hoffmann La Roche Ltd. | 11/03/2021 | 20210311 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2020-005759-18 | Authorised→Not Recruiting | Yes | | | <br>Female: yes<br>Male: yes<br> | 10/05/2021 | 1386 | Interventional clinical trial of medicinal product | Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: yes
Other: no
Number of treatment arms in the trial: 2
→Controlled: yes<br>Randomised: yes<br>Open: no<br>Single blind: no<br>Double blind: yes<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: yes<br>Other: no<br>Number of treatment arms in the trial: 2<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
| Japan;Germany;Denmark;Peru;Romania;Belgium;Brazil;Poland;Argentina;Mexico;Hungary;France;Italy;Switzerland;Colombia;Russian Federation;Turkey;Ukraine;Spain;United States;Serbia;Portugal | Trial Information Support Line-TISL | | Grenzacherstrasse 124 | global.rochegenentechtrials@roche.com | | F. Hoffmann La Roche Ltd. | Inclusion criteria: <br>Age >=18 years (regardless of weight) at the time of signing informed consent or age >=12 to <18 years (weight >=40 kilogram) at the time of signing informed consent (and assent)
<br>Ability to comply with all aspects of the study protocol, including providing samples for virology, in the opinion of the investigator
<br>At least three of the following symptoms of at least moderate (score >=2 as per COVID-19 Symptom Diary) intensity: nasal congestion or runny nose, sore throat, cough, shortness of breath, muscle or body aches, fatigue, headache, chills or sweats, feeling hot or feverish, nausea, vomiting, or diarrhea
<br>Positive severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) diagnostic test (reverse-transcriptase polymerase chain reaction [RT-PCR] or validated rapid antigen test) <=72 hours prior to randomization
<br>Symptoms consistent with mild or moderate COVID-19, as determined by the Investigator, with onset <=5 days before randomization
<br>For women of childbearing potential and girls at or beyond menarche (age >=12 to <18 years): agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate contraception during the treatment period and for 30 days after the final dose of RO7496998 (AT-527)
<br>
<br><br>Are the trial subjects under 18? yes<br>Number of subjects for this age range: 150<br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 1236<br>F.1.3 Elderly (>=65 years) no<br>F.1.3.1 Number of subjects for this age range <br> | Exclusion criteria: <br>Clinical signs indicative of COVID-19 illness requiring hospitalization
<br>Admitted to a hospital prior to randomization or is hospitalized
<br>(inpatient) at randomization due to COVID-19
<br>In the opinion of the investigator, is likely to experience imminent
<br>deterioration and require hospitalization Treatment with an investigational drug within 5 half-lives or 3 months
<br>(whichever is longer) of randomization Treatment with a COVID-19 therapeutic agent against SARS-CoV-2 including, but not limited to, other direct or indirect acting antivirals against SARS CoV 2 (such as remdesivir or favipiravir), systemic or
<br>inhaled steroids (such as dexamethasone or inhaled budesonide), colchicine, ivermectin, interferons, convalescent plasma, monoclonal
<br>antibodies against SARS CoV-2 or Interleukin 6 (IL-2) intravenous immunoglobulin or other emergency use authorization (EUA)-approved
<br>treatments within 3 months or less than 5 drug elimination half-lives (whichever is longer) prior to the screening visit
<br>Concomitant use of P-glycoprotein (P-gp) inhibitors or inducers
<br>Known allergy or hypersensitivity to components of study drug
<br>Pregnant or breastfeeding, or intending to become pregnant during the study or within 30 days after the final dose of RO7496998 (AT-527)
<br>Abnormal laboratory test results at screening
<br>Requirement of any prohibited medications during the study
<br>Other known active viral or bacterial infection at the time of screening, such as influenza. This exclusion does not apply to patients with stable chronic viral infections, such as chronic HCV or HIV providing other eligibility criteria are met
<br>Any clinically significant medical condition or laboratory abnormality
<br>that, in the opinion of the investigator, could jeopardize the safety of the patient or affect patient compliance or safety/efficacy observations
<br>during the study COVID 19 vaccination within <=40 days prior to enrollment (second dose if applicable)<br> | Mild to Moderate coronavirus disease 2019 (COVID-19) <br>MedDRA version: 23.1
Level: LLT
Classification code 10084401
Term: COVID-19 respiratory infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Product Name: RO7496998 hemisulfate (AT-527)<br>Product Code: RO7496998<br>Pharmaceutical Form: Tablet<br>INN or Proposed INN: Not available yet<br>CAS Number: 2241337-84-6<br>Current Sponsor code: RO7496998<br>Other descriptive name: AT-527<br>Concentration unit: mg milligram(s)<br>Concentration type: equal<br>Concentration number: 275-<br>Pharmaceutical form of the placebo: Tablet<br>Route of administration of the placebo: Oral use<br><br> | Timepoint(s) of evaluation of this end point: 1. Day 1 to day 29;Primary end point(s): 1.Time to alleviation or improvement of COVID-19 symptoms (Items 1- 12 of the COVID-19 symptom diary) maintained for a duration of 21.5<br>hours defined as follows:<br>For new symptoms: time from randomization to the alleviation of COVID 19 symptoms (i.e., a score of 0 [none] or 1 [mild] on the COVID 19<br>Symptom Diary)<br>For preexisting symptoms: time from randomization to when a patient's symptoms have been maintained or improved (Note: Improved requires<br>at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale)<br><br>;Secondary Objective: -To evaluate the efficacy of RO7496998 (AT-527) compared with placebo (defined as the time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours) based on:<br>Time to alleviation or improvement of COVID-19 symptoms<br>Time to alleviation of symptoms<br>Time to one-category improvement of baseline presenting COVID-19 symptoms<br>Time to alleviation of individual symptoms<br>Proportion of patients requiring hospitalization for COVID-19<br>Proportion of patients with >=1 COVID-19 related medically attended visit through to study end Duration of fever<br>Frequency of COVID-19 related complications,<br>Proportion of patients with any post-treatment infection<br>Proportion of patients with all-cause mortality<br>-To evaluate the antiviral activity of RO7496998 (AT-527) compared with placebo<br>-To evaluate the safety of RO7496998 (AT-527) compared with placebo<br>-To characterize the pharmacokinetic (PK) profile of AT-511 and major metabolites in plasma<br><br>;Main Objective: To evaluate the efficacy of RO7496998 (AT-527) compared with placebo based on the time to alleviation or improvement of COVID-19 symptoms→Primary end point(s): 1.Time to alleviation or improvement of COVID-19 symptoms (Items 1- 12 of the COVID-19 symptom diary) maintained for a duration of 21.5<br>hours defined as follows:<br>For new symptoms: time from randomization to the alleviation of COVID 19 symptoms (i.e., a score of 0 [none] or 1 [mild] on the COVID 19<br>Symptom Diary)<br>For preexisting symptoms: time from randomization to when a patient's symptoms have been maintained or improved (Note: Improved requires<br>at least a single category improvement from baseline on the COVID-19 Symptom Diary Likert scale)<br><br>;Timepoint(s) of evaluation of this end point: 1. Day 1 to day 29;Secondary Objective: -To evaluate the efficacy of RO7496998 (AT-527) compared with placebo (defined as the time from randomization to the point at which the following criterion is met and maintained for at least 21.5 hours) based on:<br>Time to alleviation or improvement of COVID-19 symptoms<br>Time to alleviation of symptoms<br>Time to one-category improvement of baseline presenting COVID-19 symptoms<br>Time to alleviation of individual symptoms<br>Proportion of patients requiring hospitalization for COVID-19<br>Proportion of patients with >=1 COVID-19 related medically attended visit through to study end Duration of fever<br>Frequency of COVID-19 related complications,<br>Proportion of patients with any post-treatment infection<br>Proportion of patients with all-cause mortality<br>-To evaluate the antiviral activity of RO7496998 (AT-527) compared with placebo<br>-To evaluate the safety of RO7496998 (AT-527) compared with placebo<br>-To characterize the pharmacokinetic (PK) profile of AT-511 and major metabolites in plasma<br><br>;Main Objective: To evaluate the efficacy of RO7496998 (AT-527) compared with placebo based on the time to alleviation or improvement of COVID-19 symptoms | | | | Yes | True | parent | |
| → | EUCTR2021-001040-10-AT | 3 May 2021→15 November 2021 | Humoral (antibodies) and cellular (white blood cells) immune response to COVID-19 vaccines in immunocompromised (people with impaired immune system) and healthy individuals – The CoVVac study | Humoral and cellular immune response to COVID-19 vaccines in immunocompromised and healthy individuals – The CoVVac study - The CoVVac study | | Medical University of Graz | 26/03/2021 | 20210326 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-001040-10 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | 26/04/2021 | 390 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Austria | Clinical Trials Information | | Auenbruggerplatz 2 | martin.stradner@medunigraz.at | | Medical University of Graz | Inclusion criteria: <br>In order to be enrolled, participants must be 18 years or older, able to understand study procedures, provide written informed consent (Biobank informed consent and study specific informed consent), and meet one of the following inclusion criteria:<br>1. Noninfectious immunocompetent participants (i.e., healthy participants) as determined by medical history and clinical judgement. <br>or<br>2. Patients with primary immunodeficiencies<br>or<br>3. Patients with B-cell depleting therapy due autoimmune disease<br>or<br>4. Patients with benign and malignant hematological diseases receiving specific treatments with known immunosuppressive effects including cytotoxic agents, systemic corticosteroids, monoclonal antibodies and targeted therapies.<br>or<br>5. Patients with active hematological diseases and secondary immunoglobulin deficiency (e.g. CLL, MM) currently not receiving specific treatment.<br>or<br>6. Patients >3 months but <12 months after autologous HSCT.<br>or<br>7. Patients >3 months but <12 months after allogeneic HSCT.<br>or<br>8. Recipients of HSCT >12 months after allogeneic HSCT but under immunosuppressive therapy.<br>or<br>9. Patients with chronic GvHD and persistent immunodeficiency.<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 195<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 195<br> | Exclusion criteria: <br>Subjects meeting any of the following criteria cannot be enrolled into the trial:<br><br>Healthy participants<br>1. Presence of diseases or therapies that are likely to interfere with the immune response to vaccination.<br>2. Presence of a disease requiring change in therapy during 4 weeks before enrollment.<br>3. Any contraindications to the vaccine planned to receive as listed in the product characteristics.<br>4. Lack of willingness to undergo serial blood draws and attend follow-up appointments.<br>5. Women who are pregnant or breastfeeding.<br>6. Previous vaccination with any coronavirus vaccine.<br>7. Persons who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).<br><br>Immunodeficient participants<br>1. Patients with hematological diseases within three months from B-cell-depleting immunotherapy (rituximab, ofatumumab, obinutuzumab, blinatumomab, CAR-T cells).<br>2. Patients with hematological malignancies in remission and >12 months after end of specific therapy.<br>3. Patients within three months from HSCT.<br>4. Any contraindications to the vaccine planned to receive as listed in the product characteristics.<br>5. Lack of willingness to undergo serial blood draws and attend follow-up appointments.<br>6. Women who are pregnant or breastfeeding.<br>7. Previous vaccination with any coronavirus vaccine (exception: if serum prior to vaccination is available from the biobank).<br>8. Patients who are not willing to sign the informed consents (biobank informed consent and study specific informed consent).<br> | Active immunisation to prevent COVID-19 in immunocompromised individuals. <br>MedDRA version: 23.1
Level: PT
Classification code 10084457
Term: COVID-19 immunisation
System Organ Class: 10042613 - Surgical and medical procedures
;Therapeutic area: Health Care [N] - Population Characteristics [N01] | <br>Trade Name: Comirnaty concentrate for dispersion for injection<br>Pharmaceutical Form: Concentrate for solution for injection<br>INN or Proposed INN: COVID-19 mRNA Vaccine<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br>Trade Name: COVID-19 Vaccine Moderna dispersion for injection<br>COVID-19 mRNA Vaccine (nucleoside modified)<br>Pharmaceutical Form: Concentrate for solution for injection<br>INN or Proposed INN: COVID-19 mRNA Vaccine<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br>Trade Name: COVID-19 Vaccine AstraZeneca suspension for injection<br>COVID-19 Vaccine (ChAdOx1-S [recombinant])<br><br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: COVID-19 Vaccine<br>Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)<br>Concentration unit: U unit(s)<br>Concentration type: not less then<br>Concentration number: 2.5E8-<br><br>→<br>Trade Name: Comirnaty concentrate for dispersion for injection<br>Pharmaceutical Form: Concentrate for solution for injection<br>INN or Proposed INN: COVID-19 mRNA Vaccine<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 30-<br><br>Trade Name: Spikevax dispersion for injection<br>COVID-19 mRNA Vaccine (nucleoside modified)<br>Pharmaceutical Form: Concentrate for solution for injection<br>INN or Proposed INN: COVID-19 mRNA Vaccine<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: µg microgram(s)<br>Concentration type: equal<br>Concentration number: 100-<br><br>Trade Name: Vaxzevria suspension for injection<br>COVID-19 Vaccine (ChAdOx1-S [recombinant])<br><br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: COVID-19 Vaccine<br>Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)<br>Concentration unit: U unit(s)<br>Concentration type: not less then<br>Concentration number: 2.5E8-<br><br> | Timepoint(s) of evaluation of this end point: Day 21-28 after the second vaccination.;Primary end point(s): The seroconversion leading to anti-SARS-CoV-2 spike protein humoral immune response at day 21-28 after the second vaccination measured by SARS-CoV-2 antigen-binding Ig assay, comparing immunocompromised patients to healthy controls. ;Secondary Objective: Difference in the T cell response between healthy subjects and immunodeficient patients<br>Impact of aging of the immune system to humoral and cellular immune response<br>Impact of the various forms of immunosuppression on the vaccine-induced immune response <br>Impact of a previous SARS-CoV-2 infection and its severity on the immune response after vaccination<br>Role of previous asymptomatic SARS-CoV-2 infection on the vaccine induced response<br>Immune response difference between the various vaccines and participants<br>Difference in the induction of secretory IgA and serum IgA in comparison to the serum IgG and IgM response<br>Influence of previous infections caused by endemic CoV on the vaccine response<br>Difference in the induction of neutralizing antibodies in subsets of immunocompromised individuals and in COVID-19 recovered individuals compared to COVID-19 naïve controls?<br>Difference in the neutralizing capacity of antibodies after vaccination towards the emerging SARS-CoV-2 variants;Main Objective: Characterization of the anti-SARS-CoV-2 humoral immune response after vaccination with a focus on the anti-spike protein response: an analysis in immunocompromised patients compared to healthy controls.→Secondary Objective: Compare T cell response of healthy & immunodeficient subject<br>Differnce in seroconversion or T cell response between different vaccines<br>Impact of immune system´s aging to humoral & cellular immune response<br>Impact of the various forms of immunosuppression on the vaccine-induced response <br>Impact of previous SARS-CoV-2 infection and<br>Role of previous asymptomatic SARS-CoV-2 infection on the vaccine induced response<br>Compare immune response of the various vaccines & participants<br>Difference in the induction of secretory IgA and serum IgA in comparison to the serum IgG and IgM response<br>Influence of previous infections caused by endemic CoV on the vaccine response<br>Difference in the induction of neutralizing antibodies in subsets of immunocompromised & in COVID-19 recovered individuals compared to COVID-19 naïve controls<br>Difference in the neutralizing capacity of antibodies after vaccination towards the emerging SARS-CoV-2 variants<br>Humoral & cellular effect of a booster vaccination;Primary end point(s): The seroconversion leading to anti-SARS-CoV-2 spike protein humoral immune response at day 21-28 after the second vaccination measured by SARS-CoV-2 antigen-binding Ig assay, comparing immunocompromised patients to healthy controls. ;Main Objective: Characterization of the anti-SARS-CoV-2 humoral immune response after vaccination with a focus on the anti-spike protein response: an analysis in immunocompromised patients compared to healthy controls.;Timepoint(s) of evaluation of this end point: Day 21-28 after the second vaccination. | | | | Yes | False | | |
| → | EUCTR2021-000175-37-SE | 26 April 2021→15 November 2021 | Immunologiskt svar efter vaccinering med mRNA vaccin mot covid-19, Comirnaty, hos immunsupprimerade och immunkompetenta personer. En öppen icke randomiserad multicenterstudie i fas IV. | Immunological Responses after Vaccination for COVID-19 with the mRNA Vaccine Comirnaty in Immunosuppressed and Immunocompetent Individuals. An open, non-randomized , phase IV multicenter study
| | Karolinska Universitetssjukhuset | 22/01/2021 | 20210122 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-000175-37 | Authorised | Yes | | | <br>Female: yes<br>Male: yes<br> | 09/02/2021 | 540 | Interventional clinical trial of medicinal product | Controlled: no
Randomised: no
Open: yes
Single blind: no
Double blind: no
Parallel group: yes
Cross over: no
Other: no
If controlled, specify comparator, Other Medicinial Product: no
Placebo: no
Other: no
→Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: yes<br>Cross over: no<br>Other: no<br>If controlled, specify comparator, Other Medicinial Product: no<br>Placebo: no<br>Other: no<br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Sweden | Sponsor representant | | ME Infektionssjukdomar | soo.aleman@sll.se→markus.birk@regionstockholm.se | +4672595 7225→+46858580000 | Karolinska Universitetssjukhuset | Inclusion criteria: <br>1. Individer som är =18 år gamla<br>2a. Individer med immunosuppressiv sjukdom som uppfyller ett av följande kriterier enligt prövarens bedömning<br>- Primär immunbrist<br>- HIV-infektion<br>- Genomgången allogen stamcellstransplantation/CAR T cellsbehandling<br>- Genomgången solid organtransplantation<br>- Kronisk lymfatisk leukemi<br> eller<br>2b Individer utan immunsuppressiv sjukdom eller behandling som saknar signifikant co-morbiditet enligt prövarens bedömning<br>3. Signerat skriftligt samtycke till att delta i studien<br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 270<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 270<br> | Exclusion criteria: <br>1. Tidigare eller pågående covid-19.<br>2. Har koagulationssjukdomar, andra tillstånd som är associerad med förlängd blödningstid, eller antikoagulantia behandlingar, som enligt prövaren kontraindicerar intramuskulär injektion. Tillstånd som kan korrigeras med åtgärder såsom behandlingar med trombocytkoncentrat, koagulationsfaktorer eller andra åtgärder för personer som står för antikoagulantia, är inte exkluderande kriterier.<br>3. Planerad att få ett annat vaccin inom 14 dagar före första dos av studievaccinet, eller under tiden från första dos av studievaccinet fram till 14 dagar efter andra dos av studievaccinet, och vaccination med annat vaccin som enligt prövarens bedömning inte kan planeras utanför dessa tidsperioder. <br>4. Graviditet eller amning.<br>5. Överkänslighet mot den aktiva substansen eller mot något hjälpämne som ingår i vaccinet<br>6. Individer som inte kan förstå forskningspersonsinformationen. <br>7. Individer som av annan orsak av prövare bedöms som ej lämpliga för inklusion.<br> | SARS-COV-2 Infection <br>MedDRA version: 23.0
Level: LLT
Classification code 10084272
Term: SARS-CoV-2 infection
System Organ Class: 100000004862
;Therapeutic area: Diseases [C] - Virus Diseases [C02] | <br>Trade Name: Comirnaty<br>Product Name: Comirnaty<br>Pharmaceutical Form: Concentrate for solution for injection<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br><br> | Timepoint(s) of evaluation of this end point: 2 veckor efter andra vaccindos.;Primary end point(s): Andel (95% CI) som serokonverterar till positivt svar på SARS-CoV-2 IgG serologiprov efter två doser av vaccin, mätt 2 veckor efter andra vaccindos;Secondary Objective: Att utvärdera säkerhet och tolerabilitet av det givna vaccinet hos forskningspersonerna. <br><br>Att mäta förekomst av SARS-CoV-2 infektion dokumenterad genom positivt PCR prov under studieperioden<br><br><br>;Main Objective: Undersöka immunologisk effekt av Comirnaty, genom att mäta förekomst av serokonversion (utveckling av antikroppar mot SARS-CoV-2 vid vaccination hos seronegativa individer) efter 2 vaccindoser→Secondary Objective: Att utvärdera säkerhet och tolerabilitet av det givna vaccinet hos forskningspersonerna. <br><br>Att mäta förekomst av SARS-CoV-2 infektion dokumenterad genom positivt PCR prov under studieperioden<br><br><br>;Main Objective: Undersöka immunologisk effekt av Comirnaty, genom att mäta förekomst av serokonversion (utveckling av antikroppar mot SARS-CoV-2 vid vaccination hos seronegativa individer) efter 2 vaccindoser;Timepoint(s) of evaluation of this end point: 2 veckor efter andra vaccindos.;Primary end point(s): Andel (95% CI) som serokonverterar till positivt svar på SARS-CoV-2 IgG serologiprov efter två doser av vaccin, mätt 2 veckor efter andra vaccindos | | | | Yes | True | parent | |
| → | EUCTR2021-004788-29-FI | 18 October 2021→15 November 2021 | COVID-19 vaccine immunology | COVID-19 vaccine immunological studies in Finland | | Finnish Institute for Health and Welfare | 17/09/2021 | 20210917 | EU Clinical Trials Register | https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2021-004788-29 | Authorised | No | | | <br>Female: yes<br>Male: yes<br> | | 4000 | Interventional clinical trial of medicinal product | Controlled: no<br>Randomised: no<br>Open: yes<br>Single blind: no<br>Double blind: no<br>Parallel group: no<br>Cross over: no<br>Other: yes<br>If controlled, specify comparator, Other Medicinial Product: <br>Placebo: <br>Other: <br> | Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
| Finland | Elina Isosaari | | Biokatu 6, Finn-Medi1 | elina.isosaari@thl.fi | +358295246263 | Finnish Institute for Health and Welfare | Inclusion criteria: <br>Are the trial subjects under 18? no<br>Number of subjects for this age range: <br>F.1.2 Adults (18-64 years) yes<br>F.1.2.1 Number of subjects for this age range 2500<br>F.1.3 Elderly (>=65 years) yes<br>F.1.3.1 Number of subjects for this age range 1500<br> | Exclusion criteria: <br> | <br>MedDRA version: 23.1
Level: LLT
Classification code 10084464
Term: COVID-19 immunization
System Organ Class: 100000004865
;Therapeutic area: Body processes [G] - Immune system processes [G12] | <br>Trade Name: Comirnaty<br>Pharmaceutical Form: Concentrate for dispersion for injection<br>INN or Proposed INN: COVID-19 mRNA vaccine (nucleoside-modified)<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg/ml microgram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 100-<br><br>Trade Name: Spikevax<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified)<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: µg/ml microgram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 200-<br><br>Trade Name: Vaxzevria<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recombinant])<br>Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)<br>Concentration unit: IU/ml international unit(s)/millilitre<br>Concentration type: not less then<br>Concentration number: 500000000-<br><br>Trade Name: Tutkimuksen kohteena ovat Suomen kansallisen rokoteohjelman tarjoamat COVID-19 rokotteet. Tämä koskee myös tutkimuksen aikana tällaiseen käyttöön tulevia COVID-19 rokotteita, mukaan lukien yhdistelmärokotteet.<br>Pharmaceutical Form: <br>INN or Proposed INN: COVID-19 vaccine<br>Other descriptive name: COVID-19 vaccine<br><br>→<br>Trade Name: Comirnaty<br>Pharmaceutical Form: Concentrate for dispersion for injection<br>INN or Proposed INN: COVID-19 mRNA vaccine (nucleoside-modified)<br>Other descriptive name: COVID-19 mRNA vaccine (nucleoside-modified)<br>Concentration unit: µg/ml microgram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 100-<br><br>Trade Name: Spikevax<br>Pharmaceutical Form: Dispersion for injection<br>INN or Proposed INN: COVID-19 mRNA Vaccine (nucleoside modified)<br>Other descriptive name: COVID-19 mRNA vaccine Moderna (CX-024414)<br>Concentration unit: µg/ml microgram(s)/millilitre<br>Concentration type: equal<br>Concentration number: 200-<br><br>Trade Name: Vaxzevria<br>Pharmaceutical Form: Suspension for injection<br>INN or Proposed INN: COVID-19 Vaccine (ChAdOx1-S [recombinant])<br>Other descriptive name: COVID-19 vaccine AstraZeneca (ChAdOx1 nCoV-19)<br>Concentration unit: IU/ml international unit(s)/millilitre<br>Concentration type: not less then<br>Concentration number: 500000000-<br><br>Trade Name: Tutkimuksen kohteena ovat Suomen kansallisen koronarokoteohjelman tarjoamat COVID-19 rokotteet. <br>Tämä koskee myös tutkimuksen aikana tällaiseen käyttöön tulevia COVID-19 rokotteita, mukaan lukien yhdistelmärokotteet.<br>Pharmaceutical Form: <br>INN or Proposed INN: COVID-19 vaccine<br>Other descriptive name: COVID-19 vaccine<br><br> | Primary end point(s): ;Secondary Objective: ;Main Objective: | | | | Yes | False | | |
| → | NL8540 | 1 November 2021→15 November 2021 | Lung ultrasound findings in patients with novel SARS CoV2 | “Lung ultrasound findings in patients with novel SARS CoV2 | | none | 19/04/2020 | 20200419 | Netherlands Trial Register | https://trialregister.nl/trial/8540 | Not Recruiting | No | | | | 26/03/2020 | 50 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Mark | Haaksma | | m.haaksma@amsterdamumc.nl | 0648072416 | | Inclusion criteria: adult, admitted to ICU, positive test for SARS CoV2, lung ultrasound received | Exclusion criteria: no ultrasound | SARS CoV 2 | | Frequency of lung ultrasound characteristics as absolute number and percentage overall and per symptom duration group, correlation with parameters such as P/F ratio, volume status and pulmonary compliance | | | | No | False | | |
| → | NL8536 | 1 November 2021→15 November 2021 | Neurological Manifestations of COVID-19 and Indications of an Association with Respiratory Failure | Neurological Manifestations of COVID-19 and Indications of an Association with Respiratory Failure | | Zuyderland Medisch Centrum | 15/04/2020 | 20200415 | Netherlands Trial Register | https://trialregister.nl/trial/8536 | Recruiting | No | | | | 28/04/2020 | 285 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | M. | Beckers | | mil.beckers@zuyderland.nl | 088-4599717 | | Inclusion criteria: • Patients who are, or were, treated by the COVID medical team of Zuyderland Medisch Centrum due to one or more complaints because of which they were suspected of COVID-19 as per local hospital protocol<br>• Classified as either confirmed or negative COVID-19, based upon the contemporary WHO case definition, or investigations ordered to reach one of these classifications<br>• Age =18 years<br>• Capable of adequately answering questions about neurological symptoms | Exclusion criteria: • Patients in whom no definitive classification of COVID-19 status (confirmed or negative) has been reached | COVID-19 | | Incidence of neurological symptoms | | | | Yes | False | | |
| → | NL8512 | 1 November 2021→15 November 2021 | The use of ACE2 receptor increasing medication at hospital admission and
mortality rates in COVID-19 patiënts
| The use of ACE2 receptor increasing medication at hospital admission and
mortality rates in COVID-19 patiënts
| | nonen | 02/04/2020 | 20200402 | Netherlands Trial Register | https://trialregister.nl/trial/8512 | Recruiting | No | | | | 18/03/2020 | 400 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Diederik | van Wijk | | DF.van.Wijk@nwz.nl | 088-085-7589 | | Inclusion criteria: Clinical diagnosis of COVID-19<br>Intubation for mechanical respiratory support (including<br>ECMO) <br> | Exclusion criteria: None | COVID-19 | | mortality and end of mechanical respiratory support. | | | | No | False | | |
| → | NL9053 | 1 November 2021→15 November 2021 | Evolution of diaphragm and abdominal muscle thickness in ventilated COVID-19 patients | Evolution of diaphragm and abdominal muscle thickness in ventilated COVID-19 patients | | none | 17/11/2020 | 20201117 | Netherlands Trial Register | https://trialregister.nl/trial/9053 | Recruiting | No | | | | 09/11/2020 | 40 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Mark | Haaksma | | m.haaksma@amsterdamumc.nl | 0648072416 | | Inclusion criteria: Patients tested positive for SARS Corona Virus 2 and ventilated for >72 hours | Exclusion criteria: Extubation within 72 hours of intubation, Diaphragm paralysis, Spinal cord injury | COVID-19 | | Diaphragm and abdominal muscle thickness assessed by ultrasound | | | | No | False | | |
| → | NL8520 | 1 November 2021→15 November 2021 | SARS-CoV-2 Observational Study | SARS-CoV-2 Observational Study of patients with acute respiratory tract infection in European primary care | | UMC Utrecht | 12/04/2020 | 20200412 | Netherlands Trial Register | https://trialregister.nl/trial/8520 | Not Recruiting | No | | | | 14/04/2020 | 600 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Alike | van der Velden | | a.w.vandervelden@umcutrecht.nl | 31 88-756 8511 | | Inclusion criteria: • Male or female aged one year or older;<br>• Consulting face-to-face, online, or telephoning with symptoms of CA-ARTI (upper and or lower), with symptoms of cough, sore throat and/or rhinitis, or when the GP has another reason to suspect COVID-19;<br>• Is able and willing to comply with all study requirements;<br>• Participant or legal guardian(s) of a child is able and willing to give informed consent;<br>• Availability of a freezer at the practice, patient’s home, or a laboratory location to be reached within 1 hour. | Exclusion criteria: • Patients with symptoms of earache only;<br>• Patients who do not master the national language or are otherwise not able to participate in follow-up procedures;<br>• Patients who are terminally ill;<br>• Patients tested positive for SARS-CoV-2 prior to recruitment. | acute respiratory tract infection | none | The proportion of COVID-19 in patients presenting with CA-ARTI in primary care | | | | Yes | False | | |
| → | NL8551 | 1 November 2021→15 November 2021 | Covid High-intensity Immunosuppression in Cytokine release syndrome | Outcomes of patients with COVID-19 related cytokine release syndrome under immunosuppressive treatment | | Zuyderland Medical Center | 23/04/2020 | 20200423 | Netherlands Trial Register | https://trialregister.nl/trial/8551 | Recruiting | No | | | | 23/04/2020 | 160 | Observational |
Randomized: No,
Masking: None,
Control: Unknown,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Unknown, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Sofia | Ramiro | | sofiaramiro@gmail.com | +31626568596 | | Inclusion criteria: Eligibility for immunosuppressive treatment is based on the Zuyderland treatment protocol (named; ‘Standpunt werkwijze behandeling COVID Zuyderland’, due to frequent updates will the most recent version be leading at any time).<br>According to Zuyderland treatment protocol version from 01.04.2020, this means:<br>1. Detection of diffuse interstitial pneumonia or bilateral infiltrations on chest x-ray or CO-RADS score =4 based on CT-thorax findings<br>2. Oxygen saturation at rest in ambient air = 94% or tachypnea =30/min.<br>3. Presence of at least 2 of the following risk factors for CRS<br>a. High ferritin (> 900 ug/L or two times the level at admission within 48 hours)<br>b. High C-reactive protein (> 100 mg/L)<br>c. High D-dimer (> 1500 ug/L) | Exclusion criteria: No specific exclusion criteria | COVID-19 pneumonia | Methylprednisolone, eventually supplemented by tocilizumab | 1. Time to clinical improvement: defined as the time from start of immunosuppressive treatment to improvement of at least 2 points on an ordinal scale 1-7 or hospital discharge, whichever comes first. This endpoint is recommended by WHO and used as the primary endpoint in the Lopinavir-Ritonavir trial. (17) The ordinal scale categories are: 1) non-hospitalized, able to resume normal activities; 2) non-hospitalized, but unable to resume normal activities; 3) hospitalized, not requiring oxygen therapy; 4) hospitalized, requiring additional oxygen therapy; 5) hospitalized, requiring high-flow nasal oxygen therapy, non-invasive mechanical ventilation, or both; 6) hospitalized, requiring ECMO, mechanical ventilation, or both; and 7) death.<br> | | | | Yes | False | | |
| → | NL9342 | 1 November 2021→15 November 2021 | Research into the effect of the COVID-19 vaccines on patients with rheumatoid arthritis, treated with rituximab | Humoral response to COVID-19 vaccination after rituximab, and relation with dose and vaccination timing. A prospective cohort study. | | Sint Maartenskliniek | 16/03/2021 | 20210316 | Netherlands Trial Register | https://trialregister.nl/trial/9342 | Not Recruiting | No | | | | 28/03/2021 | 270 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Celeste | van der Togt | | C.vanderTogt@maartenskliniek.nl | 024 3272793 | | Inclusion criteria: Rheumatoid arthritis (either 2010 ACR/EULAR RA criteria and/or 1987 ACR RA criteria and/or clinical diagnosis of the treating rheumatologist); <br>Treatment with at least one dose of rituximab in the year prior to the first COVID-19 vaccine dose; <br>Expected to receive a registered COVID-19 vaccine or has received a registered COVID-19 vaccine in the last 6 months;<br>> 16 years old and mentally competent;<br>Ability to read and communicate in Dutch. | Exclusion criteria: Not eligible (for example allergic to one of the vaccine ingredients) or not willing to receive the COVID-19 vaccine. | Rheumatoid arthritis | | Response against COVID-19 vaccine 2-4 weeks after last vaccine dose, measured by IgT antibody index titre against COVID-19 (IgT >= 1.1) | | | | Yes | False | | |
| → | NL8501 | 1 November 2021→15 November 2021 | Using eHealth to support COVID-19 education, self-assessment and symptom tracking. | Using eHealth to support COVID-19 education, self-assessment and symptom tracking. An observational study in The Netherlands. | | Interactive Studios | 01/04/2020 | 20200401 | Netherlands Trial Register | https://trialregister.nl/trial/8501 | Recruiting | No | | | | 23/03/2020 | 2000 | Observational |
Randomized: No,
Masking: Unknown,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: Unknown, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Thomas | Timmers | | thomas@interactivestudios.nl | 0031650617047 | | Inclusion criteria: Patients need to have a smartphone and install the app that is provided to them through their own hospital. | Exclusion criteria: No possession of smartphone or tablet, no understanding of Dutch language. | COVID-19 | NA | Number of people that download the app and choose to check their health, perform the self-assessment and use the 7 day self-reported symptoms diary for one or more days. | | | | No | False | | |
| → | NL8522 | 1 November 2021→15 November 2021 | The Digital Doc in the Emergency Department: The solution for patient care in the Covid-19 pandemic? | The Digital Doc in the Emergency Department: The solution for patient care in the Covid-19 pandemic? | | none | 12/04/2020 | 20200412 | Netherlands Trial Register | https://trialregister.nl/trial/8522 | Recruiting | No | | | | 08/04/2020 | 50 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Bart | Candel | | bart.candel@mmc.nl | 0644665616 | | Inclusion criteria: Patients treated in the ED in contact isolation. | Exclusion criteria: 15L O2/min. cognitive impairment, GCS<15, <18years | Suspicion for Covid-19 | Telemedicine by Ipads | Number of PPE used per patient | | | | No | False | | |
| → | NL8523 | 1 November 2021→15 November 2021 | Volatile Anaesthetics in COVID-19 – a pilot study | Volatile agents for sedation in patients with COVID-19-associated acute respiratory distress syndrome – a pilot study | | University Medical Center Utrecht | 13/04/2020 | 20200413 | Netherlands Trial Register | https://trialregister.nl/trial/8523 | Not Recruiting | No | | | | 26/04/2020 | 20 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Jan | Dieleman | | j.m.dieleman@umcutrecht.nl | +61406982659 | | Inclusion criteria: • Confirmed or suspected COVID-19 <br>• Respiratory failure requiring mechanical ventilation through an endotracheal tube<br>• Ventilation using a ventilator that is capable of delivering sevoflurane or isoflurane<br>• >18 years of age | Exclusion criteria: • Suspected or proven intracranial hypertension <br>• Tidal volume (6 ml/kg predicted body weight [PBW]) less than 250 ml<br>• Malignant hyperthermia history, or family risk factors<br>• History of long QT syndrome<br>• Severe liver failure<br>• Previous kidney or liver transplantation<br>• Requirement for extracorporeal mechanical respiratory or circulatory support | COVID-19, ARDS | The administration of inhaled isoflurane for sedation, compared to intravenous sedation. In this pilot study, patients will intermittent receive inhaled or intravenous sedation, according to the randomisation scheme. | Change in PaO2/FiO2 (P/F) ratio, oxygenation index, and ventilation parameters | | | | Yes | False | | |
| → | NL8563 | 1 November 2021→15 November 2021 | Patient’s knowledge And behavior oN the COVID-19 disease and as DEterMInants of Contamination | Patient’s knowledge And behavior oN the COVID-19 disease and as DEterMInants of Contamination | | None | 22/04/2020 | 20200422 | Netherlands Trial Register | https://trialregister.nl/trial/8563 | Recruiting | No | | | | 22/04/2020 | 170 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Hanna | van der Valk | | h.kuipervandervalk@gmail.com | 0642192700 | | Inclusion criteria: Covid | Exclusion criteria: adult patients subject to COVID-19 infection screening at the emergency room | COVID-19 | Questionnaires | Risk perception | | | | Yes | False | | |
| → | NL8570 | 1 November 2021→15 November 2021 | COVID-19 infections in health care workers | Nosocomial COVID-19 infections in health care workers | | Franciscus Gasthuis & Vlietland | 29/04/2020 | 20200429 | Netherlands Trial Register | https://trialregister.nl/trial/8570 | Not Recruiting | No | | | | 10/05/2020 | 300 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Hans | Koeleman | | h.koeleman@franciscus.nl | +31104616076 | | Inclusion criteria: Healthcare workers exposed to COVID-19 patients and health care workers who are not exposed to patients. | Exclusion criteria: Age below 18. Health care workers who work in (outpatient) clinical departments, including emergency rooms. | COVID-19 infections | not applicable | The primary outcome measure is the number of healthcare workers with and without specific COVID-19 antibodies. | | | | Yes | False | | |
| → | NL8529 | 1 November 2021→15 November 2021 | General practice cooperative COVID-19 centre Urmond | Monitoring patient flow at general practice cooperative COVID-19 centre Urmond | | MCC Omnes (Sittard) | 14/04/2020 | 20200414 | Netherlands Trial Register | https://trialregister.nl/trial/8529 | Not Recruiting | No | | | | 01/05/2020 | 2000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Luc | Gidding | | info@gmda.nl | 0644882499 | | Inclusion criteria: Age = 18 years and the GP deciding it is a COVID-19 related consultation | Exclusion criteria: None | COVID-19 infection | | COVID-19 infection | | | | Yes | False | | |
| → | NL9780 | 1 November 2021→15 November 2021 | The COVid cohORT on Smell loss | The COVid cohORT on Smell loss | | WUR | 07/10/2021 | 20211007 | Netherlands Trial Register | https://trialregister.nl/trial/9780 | Recruiting | No | | | | 01/10/2021 | 75 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Elbrich | Postma | | elbrich.postma@wur.nl | +31622877213 | | Inclusion criteria: Aged between 18-60 years, as olfactory function typically declines after the age of 60 years; recent Covid-19 infection (< 3 months), confirmed with a positive PCR-test, performed at a hospital or by the GGD; persistent self-reported smell loss (> 1 month); willing to comply with the study procedures; Dutch speaking; having given informed consent | Exclusion criteria: Having any pre-existing olfactory or gustatory disorders (i.e. more than 2 weeks prior to the Covid-infection) | COVID-19 | N/A | Objective assessment of parosmia by means of the SSParoT; objective?olfactory function by means of?Sniffin’?Sticks; objective gustatory function by means of?Taste Strips. For the neuroimaging part: activation of brain regions in response to odor administration; activation of functional connectivity networks in the brain in response to odor administration; volume of the olfactory bulbs; total brain volume and volume of olfactory-related brain regions | | | | No | False | | |
| → | NL8572 | 1 November 2021→15 November 2021 | Prevalence of asymptomatic deep vein thrombosis in admitted COVID-19 patients | Prevalence of asymptomatic deep vein thrombosis in admitted COVID-19 patients | | UMCG | 30/04/2020 | 20200430 | Netherlands Trial Register | https://trialregister.nl/trial/8572 | Recruiting | No | | | | 19/04/2020 | 100 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Hilde | Kooistra | | h.a.m.kooistra@umcg.nl | +31621258853 | | Inclusion criteria: - Age (= 18 years)<br>- Proven (PCR) or suspected (based on clinical signs and imaging) COVID-19 infection<br>- Certified sonographer present | Exclusion criteria: - Clinical suspicion of DVT<br>- No informed consent obtained<br>- Absence of COVID infection | COVID and DVT | None | Prevalence of VTE | | | | No | False | | |
| → | NL8575 | 1 November 2021→15 November 2021 | COVID MILK | COVID MILK | | Investigator Inititiated; Hans van Goudoever | 02/05/2020 | 20200502 | Netherlands Trial Register | https://trialregister.nl/trial/8575 | Recruiting | No | | | | 01/05/2020 | 60 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Johannes (Hans) B. | van Goudoever | | h.vangoudoever@amsterdamumc.nl | 0205668885 | | Inclusion criteria: Natural surplus of milk, PCR proven COVID infection or very high likelihood of COVID (Clinical symptoms and a family member with PCR proven COVID infection) | Exclusion criteria: negative antibody response | COVID infection | none | Concentrations and efficacy of antibodies against SARS-CoV-2 in raw and pasteurized milk | | | | No | False | | |
| → | NL8576 | 1 November 2021→15 November 2021 | Effect van COVID-19 op kwaliteit van leven bij astma | Effects of COVID-19 on quality of life and mental health in asthma | | Stichting O&O Franciscus Gasthuis & Vlietland | 20/04/2020 | 20200420 | Netherlands Trial Register | https://trialregister.nl/trial/8576 | Not Recruiting | No | | | | 20/04/2020 | 80 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Geertje | de Boer | | G.Boer3@Franciscus.nl | +31646189710 | | Inclusion criteria: Included in either Breathe (NL5752) or Grandma (NCT03278561) study. | Exclusion criteria: - Did not agree to be asked for future research.<br>- Dropped out of Breathe study within 6 months after study initiation | Asthma | Surveys | - mental health status before and during a pandemic<br>- number of respiratory tract infections and asthma exacerbations before and during a pandemic<br> | | | | Yes | False | | |
| → | NL8521 | 1 November 2021→15 November 2021 | Continuous positive airway pressure in severe Covid-19 pneumonia | Continuous positive airway pressure in severe Covid-19 pneumonia: a feasibility and physiological end-point study | | Raad van Bestuur van het AMC (Amsterdam) | 13/04/2020 | 20200413 | Netherlands Trial Register | https://trialregister.nl/trial/8521 | Not Recruiting | No | | | | 08/05/2020 | 13 | Interventional |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Joost | van den Aardweg | | j.g.vandenaardweg@amsterdamumc.nl | 020-5669111 | | Inclusion criteria: A subject must meet all of the following criteria:<br>- age > 18 years <br>- Positive for Covid-19 (CORADS 5, i.e. highly likely Covid-19 on the low-dose CT scan, or PCR positive nasopharyngeal swab for SARS Coronavirus 2). <br>- Admitted to Amsterdam UMC, location AMC. <br>- A transcutaneous O2 saturation (SpO2) of 90% or less at 5 l/min oxygen administration via nasal canula.<br>- Provide informed consent. <br> | Exclusion criteria: - Hypercapnia (defined as arterial PCO2 > 6.0 kPa or 45 mmHg)<br>- A history of moderate to severe Chronic Obstructive Pulmonary Disease (COPD, GOLD severity III or IV), restrictive lung disease, or Obesity Hypoventilation Syndrome<br>- Need for intubation or admission to the Intensive Care Unit as determined by the responsible physician<br>- Palliative care <br>- Reduced consciousness<br>- Vomiting <br>- Unability to wear the mask due to anatomical / physical restriction (e.g. facial operations; bearded) <br>- Unable to provide informed consent. <br><br> | Corona virus disease 2019 (Covid-19), proven with PCR on nasopharyngeal swab and with matching abnormalities on low-dose CT-scan | Three conditions are tested (each lasting 30 min, the ‘measurement period’): <br>1. Oxygen delivery via a nonrebreathing mask (current standard of care) with sufficient inflow of O2 (which does not create PEEP). <br>2. Oxygen delivery via the face mask with zero PEEP in order to test the effect of the mask alone. <br>3. Oxygen delivery via the face mask with PEEP of 7.5 cmH2O in order to test effect of moderate PEEP. | A change in the two-dimensional variable (SpO2, RR), the combination of oxygen saturation and respiratory rate.<br>SpO2 is measured with a pulse oximeter and RR is derived from the pressure changes in the mouth compartment of the mask. <br> | | | | Yes | False | | |
| → | NL8580 | 1 November 2021→15 November 2021 | Metabolic syndrome And Severity of Covid-19 | Metabolic syndrome And Severity of Covid-19 | | None | 28/04/2020 | 20200428 | Netherlands Trial Register | https://trialregister.nl/trial/8580 | Recruiting | No | | | | 28/04/2020 | 100 | Unknown |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Cathelijne | van Zelst | | c.zelst@franciscus.nl | 06-18975719 | | Inclusion criteria: Age > 18 years old and no treatment restrictions | Exclusion criteria: Patient not able to stand straight, this is necessary to measure the hip-waist ratio. | Covid-19 infection | Any patient with a suspicion of covid-19 infection at the ER, the criteria of the metabolic syndrome were screened; glucose, hypertension (>130/85 mmHg and/ or medication), low HDL-cholesterol (men =1,04 mmmol/l; women = 1,29 mmol/l), high triglycerides (men and women = 1,7 mmol/l or statin use), abdominal obesity (hip and waist measurement in cm). | ? - BMI<br>? - Hip- waist ratio <br>? - Covid-19 laboratory test (Ferritin, triglycerides, HDL-cholesterol, CRP, procalcitonin, ALAT, ASAT, GGT, AF, glucose, LDH, sodium, potassium <br>? - CT-scan; CO-RADS and severity score<br>? - Medication use (statins, inhalation corticosteroids, antihypertension medication etc.)<br>? - Severity of covid-19 infection defined by hospitalization, oxygen suppletion and intubation and ventilation at the intensive care. <br>? - Outcome after 30 days (complete recovery, rest abnormality, deceased) <br> | | | | Yes | False | | |
| → | NL8531 | 1 November 2021→15 November 2021 | Humoral responses to SARS-CoV-2 infection in children | Humoral responses to SARS-CoV-2 infection in children | | Stichting Steun Emma | 08/04/2020 | 20200408 | Netherlands Trial Register | https://trialregister.nl/trial/8531 | Recruiting | No | | | | 12/04/2020 | 420 | Observational |
Randomized: No,
Masking: Unknown,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: Unknown, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Dasja | Pajkrt | | covidkids@amsterdamumc.nl | +31-5662727 | | Inclusion criteria: Children younger than 18 years of age | Exclusion criteria: No written informed consent from parents/ guardians or eligible child older than 12 years of age. | SARS-CoV in children | NA | At the end of the study (april 2021) we will assess the following primary outcomes<br>Blood :<br>Neutralizing antibodies (via neutralization assay)<br>IgG and IgM against SARS-CoV2 (via ELISA)<br>Saliva:<br>Secretory total IgA and specific secretory IgA against SARS-CoV2 (via ELISA) | | | | Yes | False | | |
| → | NL8584 | 1 November 2021→15 November 2021 | Lung ultrasound and computed tomography for monitoring SARS-CoV-2 in critical care departments | Lung ultrasound and computed tomography for monitoring SARS-CoV-2 in critical care departments | | None | 01/05/2020 | 20200501 | Netherlands Trial Register | https://trialregister.nl/trial/8584 | Recruiting | No | | | | 27/03/2020 | 80 | Observational |
Randomized: No,
Masking: Single,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: Single, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Micah | Heldeweg | | M.heldeweg@amsterdamumc.nl | +31643476888 | | Inclusion criteria: All adults (>18 years) admitted to the ICU and diagnosed with SARS-CoV-2. | Exclusion criteria: If no 12-zone ultrasound was performed within 48 hours before or after a chest CT-scan | SARS-CoV-2 | None | Correlation between lung ultrasound aeration score and CT severity score | | | | No | False | | |
| → | NL8578 | 1 November 2021→15 November 2021 | Alkaline phosphatase for reducing systemic inflammatory response syndrome (SIRS) in patients with Sars-CoV-2 infection and acute respiratory insufficiency (COVID 19) | Alkaline phosphatase for reducing systemic inflammatory response syndrome (SIRS) in patients with Sars-CoV-2 infection and acute respiratory insufficiency (COVID 19) | | Rode Kruis ziekenhuis Beverwijk | 02/05/2020 | 20200502 | Netherlands Trial Register | https://trialregister.nl/trial/8578 | Not Recruiting | Yes | | | | 13/07/2020 | 124 | Interventional |
Randomized: No,
Masking: Double,
Control: Placebo,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Double, <br> Control: Placebo, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | stephan | papendorp | | spapendorp@rkz.nl | 0251-265976 | | Inclusion criteria: Patients with proved or considered Sars-CoV-2 infection admitted to the ICU with type 1 or 2 respiratory failure despite supplemental oxygen.<br><br>Sars-CoV-2 infection based on: highly clinical suspicion on admission and/or positive PCR test on nasopharynx swab or sputum and/or a CT imaging of the chest compatible with COVID-19 + type 1 or type 2 respiratory failure despite supplemental oxygen that indicates airway support/ICU admittance and meeting any of the following criteria: .<br>- SpO2 <90% or PaO2 < 60 mmHg despite FiO2 >60%<br>- Clinical evidence of respiratory distress (RR > 25 breaths/minute)<br>- Respiratory acidosis (pH< 7.35) | Exclusion criteria: - Inclusion in another interventional clinical trial<br>- Age < 18<br>- Age > 80<br>- Patients who are pregnant or lactating<br>- Patients expected to have fatal disease within 24 hours<br>- Patients who are already on dialysis (Renal Replacement Therapy, RRT) or a decision has been made to initiate RRT within 24 hours after planned start of study drug administration<br>- Patients who have advanced chronic liver disease confirmed by a Child-Pugh C<br>- Patients who are having an known history of immune system that has been impaired by disease, such as patients with HIV and with a CD4 count of less than 200 cells/mm, neutropenic patients (<0.5 x 109/l) or medical treatment with immunosuppressive effects<br>- Patients with active haematological malignancy | COVID-19 | All COVID-19 patients with an indication for admittance to the ICU department will be included and will (after informed consent) be rondomised to receive a bolus of alkaline phosphatase of 1000iU, followed by 9000 iU the same day. For the 3 consecutive days 10.000iU/day on top of regular care. | Duration of mechanical ventilation | | | | Yes | True | parent | |
| → | NL8577 | 1 November 2021→15 November 2021 | Digital Cardiac Counseling Trial: DCC Trial | Randomized controlled trial of Digital Cardiac Counseling in patients with delayed cardiac surgical treatment due to Covid-19 pandemic (DCC trial) | | Academic Hospital Maastricht (Academisch Ziekenhuis Maastricht) | 06/05/2020 | 20200506 | Netherlands Trial Register | https://trialregister.nl/trial/8577 | Not Recruiting | No | | | | 15/05/2020 | 394 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Peyman | Sardari Nia | | peyman.sardarinia@mumc.nl | 0031-(0)-43-3875070 | | Inclusion criteria: -Patients who are on the waiting list for any elective cardiac operation and are older than 18 years old (adult cardiac surgery patients) during the Covid-19 pandemic<br>-Patients accepted for any elective cardiac operation and are older than 18 years during the Covid-19 pandemic (adult cardiac surgery patients) | Exclusion criteria: -Patients who are not able to use digital platforms for various reasons (blindness, illiteracy, neurological deficits, mental inability etc.)<br>-Patients who do not have an Internet connection or any digital platform and whose direct family are not able to provide that. | Cardiovascular disease | All participants will receive at the different time intervals through our custom-made Digital Cardiac Counselling platform different questionnaires related to the different known risk factors for the perioperative cardiac care and measured outcomes. Additional to above participants, the intervention group will receive through the Digital Cardiac Counselling platform different modules with E-counselling for risk factors evaluated in the questionnaires. Additional to known risk factors a Covid-19 module will be used as well.<br>Digital counselling<br><br>The digital counselling modules for intervention group are described below:<br> <br>-Screening for reduced physical fitness. If there are signs for a decreased physical condition we will refer the patient, after consultation, for a digital intake with our physiotherapist. The patients then get access to a digital module with information and videos of physical exercise training. The patient gets a trainings schedule and we will contact the patient after about 1 and 3 weeks to check their progression and to give additional advice when needed. <br> <br>-Screening for smoking. If the patient smokes and is motivated to quit smoking, we will refer, after consultation, for a digital intake with one of our stop smoking nurses. Then, a digital and telephone supported counselling will start after an informed and shared decision making with the nurse. When needed, supportive medication can be prescribed. <br> <br>-Screening for malnutrition and obesity. If there are signs of malnutrition (MUST-score) or obesity (BMI >30) we will refer the patient, after consultation, for a digital intake with a dietician. The patients then get access to a digital module with information about a healthy diet. We will contact the patient ever 2 weeks in case of malnutrition and | -What is the effect of an interactive Digital Cardiac Counseling platform with E-consulting on cumulative incidence of major adverse cardiovascular events (MACE) at 1 year after the cardiac surgery compared to the control condition (no interactive Digital Cardiac Counseling)? | | | | Yes | False | | |
| → | NL8587 | 1 November 2021→15 November 2021 | Quality of life in COVID-19 survivors | Quality of life in COVID-19 survivors after discharge from the hospital: a prospective observational multicenter study. | | Board of directors Ciro (Horn, the Netherlands). | 06/05/2020 | 20200506 | Netherlands Trial Register | https://trialregister.nl/trial/8587 | Recruiting | No | | | | 07/05/2020 | 500 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Martijn | Spruit | | martijnspruit@ciro-horn.nl | +31 (0)475 587 600 | | Inclusion criteria: - Male or female older than 18 years of age;<br>- Tested positive for COVID-19;<br>- Being discharged from the hospital after admission for COVID-19;<br>- Provided written informed consent. | Exclusion criteria: - Patients who are not able to understand the Dutch language or are otherwise not able to fill in questionnaires during the follow-up procedures;<br>- Patients who are living in a nursing home because of a diagnosis of dementia. | COVID-19 | None | Generic quality of life, measured with the 5-level EQ-5D questionnaire | | | | Yes | False | | |
| → | NL9275 | 1 November 2021→15 November 2021 | Establishing the tolerability, safety and immunogenicity of intradermal delivery of mRNA SARS-CoV-2 vaccine in healthy adults | Tolerability, safety and immunogenicity of intradermal delivery of mRNA SARS-CoV-2 vaccine | | Leiden University Medical Center | 16/02/2021 | 20210216 | Netherlands Trial Register | https://trialregister.nl/trial/9275 | Not Recruiting | No | | | | 01/03/2021 | 150 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Anna | Roukens | | a.h.e.roukens@lumc.nl | +31715262613 | | Inclusion criteria: - Male or female participants between the ages of 18 and 30 years, inclusive at randomization.<br>- Healthy participants who are determined by medical history and clinical judgment of the investigator to be eligible for inclusion in the study. Healthy participants with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included.<br>- Participants who are willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.<br>- Capable of giving personal signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the ICD and in this protocol.<br>- Females only: female volunteers of childbearing potential (i.e. have a uterus and are neither surgically sterilized nor postmenopausal) must not be pregnant or breastfeeding. They should agree to use adequate contraception at least up to four weeks following the final dose of mRNA-1273 vaccine | Exclusion criteria: - Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study.<br>- History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).<br>- Receipt of medications intended to prevent COVID-19.<br>- Previous clinical or microbiological diagnosis of COVID-19.<br>- Individuals at high risk for severe COVID-19, who are planned to receive COVID vaccine within the next two months.<br>- Immunosuppressed individuals with known or suspected immunodeficiency, as determined by history.<br>- Individuals with a history of autoimmune disease or an active autoimmune disease requiring therapeutic intervention.<br>- Receipt of systemic or topical corticosteroids.<br>- Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.<br>- Women who are pregnant or breastfeeding.<br>- Planned pregnancy within four weeks after the final injection.<br>- Positive serological test for SARS-CoV-2 IgM and/or IgG antibodies at the screening visit.<br>- SARS-CoV-2 PCR-positive nasopharyngeal/throat swab at the screening before receipt of first vaccine dose.<br>- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.<br>- Receipt of any other non-study vaccine within 28 days, before first study dose.<br>- Anticipated receipt of any other non-study vaccine within 28 days, after last study dose administration | COVID-19 | intradermal injection of a fractional dose (10 µg and 20 µg) mRNA-1273 LPN vaccine compared to intramuscular injection of the standard dose (100 µg) mRNA-1273 LPN vaccine | - Nature, frequency and severity of local reactions. Solicited adverse events include: pain, redness and swelling at the injection site and pain and swelling at the regional lymph nodes<br>- Nature, frequency and severity of systemic events. Solicited adverse events include: fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain.<br>- Use of antipyretics and painkillers<br>- SARS-CoV-2 WT neutralizing antibody titers rate on Day 43<br>- SARS-CoV-2-spike protein–specific binding IgG level on D 43 | | | | Yes | False | | |
| → | NL8589 | 1 November 2021→15 November 2021 | Biomarker-based Early Anti-inflammatory Therapy for severe COVID-19 | Biomarker-based Early Anti-inflammatory Therapy for severe COVID-19 | | Prof. Dr. L.G. Visser | 07/05/2020 | 20200507 | Netherlands Trial Register | https://trialregister.nl/trial/8589 | Recruiting | No | | | | 23/04/2020 | 250 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Anna | Roukens | | a.h.e.roukens@lumc.nl | +31715262613 | | Inclusion criteria: - Hospitalized patient with PCR confirmed COVID-19 infection<br>- Eighteen years or older | Exclusion criteria: - Not able to give consent by representative of the subject | coronavirus; COVID-19 | N/A | Biomarker profiles or signature which correlate with future clinical progression of patients infected with SARS-CoV-2 to multi-organ failure and acute severe lung injury requiring mechanical ventilation. | | | | No | False | | |
| → | NL8528 | 1 November 2021→15 November 2021 | Control of COVID-19 in hospitals | Control of COVID-19 in hospitals (COCON-study) - Sero-epidemiology in healthcare workers | | UMC Utrecht | 15/04/2020 | 20200415 | Netherlands Trial Register | https://trialregister.nl/trial/8528 | Not Recruiting | No | | | | 22/04/2020 | 2000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Marjolein | Kluytmans | | marjoleinkluytmans@gmail.com | 06-51215336 | | Inclusion criteria: Healthcare worker employed in one of the participating hospitals | Exclusion criteria: - Age below 18 years<br>- Direct involvement in the design or execution of this study<br>- Expected absence from work for more than four weeks during follow-up<br>- Legally incapacitated or unwilling to provide informed consent<br> | COVID-19 | Not applicable | Seroprevalence of SARS-CoV-2 neutralising antibodies | | | | Yes | False | | |
| → | NL8535 | 1 November 2021→15 November 2021 | Functional status and health status in COVID-19 patients pre and post rehabilitation | Functional status and health status in COVID-19 patients pre and post rehabilitation | | Board of Directors CIRO | 15/04/2020 | 20200415 | Netherlands Trial Register | https://trialregister.nl/trial/8535 | Recruiting | No | | | | 30/03/2020 | 30 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Anouk | Vaes | | anoukvaes@ciro-horn.nl | +31 (0)475-587602 | | Inclusion criteria: COVID-10 patients referred to Ciro Horn after hospital discharge | Exclusion criteria: - | COVID-19 | | - Functional status, assessed with Short Physical Performance Battery (SPPB), hand grip strength, Medical Research Council, Medical Research Council for muscle strenght, lower-limb muscle function using a hand-held dynamometer <br>- Health status, assessed with Nijmegen Clinical Screening Instrument (NCSI), Hospital Anxiety and Depression Scale (HADS), Care Dependency Scale (CDS), European Health Literacy Survey (HLS_EU_Q16), COPD Assessment Test (CAT), Patient Activation Measure (PAM) | | | | No | False | | |
| → | NL9277 | 1 November 2021→15 November 2021 | SARS-CoV-2 specific immunity in persons with a primary immune deficiency | SARS-CoV-2 immunity in primary immune deficiency | | Leiden University Medical Center | 16/02/2021 | 20210216 | Netherlands Trial Register | https://trialregister.nl/trial/9277 | Recruiting | No | | | | 01/02/2021 | 10 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Anna | Roukens | | a.h.e.roukens@lumc.nl | +31715262613 | | Inclusion criteria: - age 18 or older<br>- diagnosed with primary immune deficiency and a patient at the Leiden University Medical Center<br>- proof of having had COVID-19 by PCR, either by GGD (municipal Health Center) of LUMC | Exclusion criteria: - vaccinated against SARS-CoV-2 | Primary Immune Deficiency | None | 1. SARS-CoV-2 specific T-cell immunity: CD4+ T cells and CD8+ T cells against SARS-CoV-2 structural proteins (N, M and S)<br>2. SARS-CoV-2 specific neutralizing antibodies | | | | No | False | | |
| → | NL9279 | 1 November 2021→15 November 2021 | VASCO study (Vaccine Study COvid-19) | VASCO study: A population-based prospective cohort study on vaccine effectiveness of COVID-19 vaccines in the Netherlands | | Dutch Ministry of Welfare and Sports | 17/02/2021 | 20210217 | Netherlands Trial Register | https://trialregister.nl/trial/9279 | Not Recruiting | No | | | | 01/03/2021 | 50000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Maartje | Hoffmann | | regulatory@juliusclinical.com | +31306569900 | | Inclusion criteria: - Community dwelling adult between 18-79 years<br>- Informed consent provided<br>- Be able to read, understand and write Dutch | Exclusion criteria: - Not able or willing to understand and sign the informed consent<br>- Not able to fill out a digital (app) questionnaire<br>- Persons living in an institution (e.g. elderly care home, nursing home) | Covid-19 | No intervention | The primary endpoint is time to first symptomatic SARS-CoV-2 infection, determined by a positive PCR or antigen test in combination with COVID-19 related symptoms. Those infections can be detected through the national testing programme. | | | | Yes | False | | |
| → | NL9281 | 1 November 2021→15 November 2021 | Confocal laser endomicroscopy in patients with non-resolving acute respiratory failure | CLE in ARDS | | Amsterdam UMC | 21/02/2021 | 20210221 | Netherlands Trial Register | https://trialregister.nl/trial/9281 | Recruiting | No | | | | 21/02/2021 | 15 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Kirsten | Kalverda | | k.a.kalverda@amsterdamumc.nl | 020 - 566 9111 | | Inclusion criteria: - =18 years of age<br>- Non-resolving acute respiratory failure mandating a standard diagnostic bronchoscopy with bronchoalveolar lavage | Exclusion criteria: - Inability and willingness to provide informed consent by family-members<br>- Patients on extra corporal membrane oxygenation (ECMO) | ARDS, COVID19 | | Identification of specific CLE patterns of the alveolar compartment in invasively ventilated COVID 19 patients | | | | Yes | False | | |
| → | NL8513 | 1 November 2021→15 November 2021 | COVID-19 in rheumatic patients: a prospective cohort study | COVID-19 in rheumatic patients: a prospective cohort study | | Reade Research BV | 07/04/2020 | 20200407 | Netherlands Trial Register | https://trialregister.nl/trial/8513 | Recruiting | No | | | | 13/04/2020 | 8000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Femke | Hooijberg | | f.hooijberg@reade.nl | 0202421633 | | Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:<br>- Age = 18 years.<br><br>For patients:<br>- Diagnosed by their treating physician with a systemic autoimmune disease.<br><br>For controls:<br>- Belonging to family or close friend of patient (of the same gender). | Exclusion criteria: Patients who meet the following criteria will be excluded from the study:<br>- Language problems precluding the completion of the questionnaire;<br>- Likelihood of absence in the next 6 months;<br>- Lack of informed consent. | All systemic autoimmune diseases | | Our primary study parameter is the percentage of participants with a positive IgM or IgG response admitted to the hospital. | | | | Yes | False | | |
| → | NL8609 | 1 November 2021→15 November 2021 | Enhancing the BCG-induced trained immunity response by addition of bisphosphonate or MMR vaccine: a possible preventive approach against COVID-19 (BCG-PLUS) | Enhancing the BCG-induced trained immunity response by addition of bisphosphonate or MMR vaccine: a possible preventive approach against COVID-19 (BCG-PLUS) | | Radboudumc | 11/05/2020 | 20200511 | Netherlands Trial Register | https://trialregister.nl/trial/8609 | Not Recruiting | No | | | | 25/05/2020 | 100 | Interventional |
Randomized: No,
Masking: None,
Control: Placebo,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Placebo, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Priya | Debisarun | | priya.debisarun@radboudumc.nl | 0243613889 | | Inclusion criteria: • Adult (18-50 years of age);<br>• Male or female;<br>• Healthy;<br>• Written informed consent<br> | Exclusion criteria: • Known allergy to (components of), or any other contraindication to, the BCG vaccine, MMR vaccine, or alendronic acid.<br>• Known (history of) active or latent Mycobacterium tuberculosis or with another mycobacterial species;<br>• Prior BCG vaccination;<br>• Acute illness 2 weeks prior to the study or (suspicion of) active infection;<br>• Pregnancy;<br>• Chronic use of any systemic drugs other than oral contraceptives;<br>• Use of NSAIDs less than 4 weeks prior to start of the study;<br>• Vaccination in the past 3 months or expected vaccination during the study period, independent of the type of vaccination;<br>• Medical history associated with immunodeficiency.<br> | COVID-19, SARS-CoV-2 | 1. Placebo treatment<br>2. BCG vaccination<br>3. BCG vaccination + oral bisphosphonate supplementation (alendronic acid)<br>4. BCG vaccination + MMR vaccine<br>5. MMR vaccine alone<br> | The main study parameter is the fold-increase in production of pro-inflammatory cytokines by PBMCs/monocytes following vaccination. | | | | Yes | False | | |
| → | NL8613 | 1 November 2021→15 November 2021 | Serial measurements in COVID-19-induced acute respiratory disease to unravel heterogeneity of the disease course: design of the Maastricht Intensive Care COVID cohort; MaastrICCht. | Serial measurements in COVID-19-induced acute respiratory disease to unravel heterogeneity of the disease course: design of the Maastricht Intensive Care COVID cohort; MaastrICCht. | | None. Investigator initiated study. | 12/05/2020 | 20200512 | Netherlands Trial Register | https://trialregister.nl/trial/8613 | Recruiting | No | | | | 23/03/2020 | 250 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Bas | van Bussel | | bas.van.bussel@mumc.nl | +31 (0)43 3876387 | | Inclusion criteria: - Intensive care admission with signs and symptoms of a viral infection<br>- Intubated and mechanically ventilated<br>- PCR positive for SARS-CoV-2 and/or a chest CT scan scored positive based on a CORADS-score of 4-5 by a radiologist | Exclusion criteria: None. | Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. | None. | Clinical data, laboratory results, EIT measurements and vital parameters will be collected within the MaastrICCht cohort. As multiple hypotheses can be investigated within the observational cohort, no predefined primary outcome for the whole cohort will be defined. <br><br>Rather, investigators have to submit a data request including a predefined analysis plan according to reporting guidelines appropriate for the type of study (i.e., STROBE for observational studies, STARD for diagnostic studies, TRIPOD for prognostic studies; see the Enhancing the QUAlity and Transparency Of health Research network at www.equator-network.org for detailed information). All external researchers submitting a data request will be required to produce a statistical analysis plan that will be reviewed by the cohort steering committee. | | | | No | False | | |
| → | NL8543 | 1 November 2021→15 November 2021 | COVID19 ultrasound triage | COVID19 ultrasound triage | | None | 18/04/2020 | 20200418 | Netherlands Trial Register | https://trialregister.nl/trial/8543 | Recruiting | No | | | | 14/04/2020 | 50 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Svenja | Haak | | s.l.haak@isala.nl | 0384247979 | | Inclusion criteria: All patients =16 years of age with suspected Covid19 infection presenting to the ED . | Exclusion criteria: Age <16 years, pre-existent heart failure, hemodynamic instability, no consent. | Covid-19 | POCUS | Admission or discharge | | | | No | False | | |
| → | NL8544 | 1 November 2021→15 November 2021 | COVID19 ultrasound diagnosis | COVID19 ultrasound diagnosis | | None | 18/04/2020 | 20200418 | Netherlands Trial Register | https://trialregister.nl/trial/8544 | Recruiting | No | | | | 18/04/2020 | 50 | Observational |
Randomized: No,
Masking: Unknown,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: Unknown, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Svenja | Haak | | s.l.haak@isala.nl | 0384247979 | | Inclusion criteria: All patients =16 years of age with suspected Covid19 infection presenting to the ED. | Exclusion criteria: Age <16 years, pre-existent heart failure, hemodynamic instability, no consent. | COVID19 | | Sensitivity and specificity of pulmonary ultrasound for the diagnosis of Covid19 syndrome | | | | Yes | False | | |
| → | NL8625 | 1 November 2021→15 November 2021 | Hocus POCUS: a tool for increasing the efficiency of diagnosing venous thromboembolic disease in critically ill COVID-19 patients? | Hocus POCUS: a tool for increasing the efficiency of diagnosing venous thromboembolic disease in critically ill COVID-19 patients? | | UMC Utrecht | 15/05/2020 | 20200515 | Netherlands Trial Register | https://trialregister.nl/trial/8625 | Recruiting | No | | | | 15/05/2020 | 50 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Dirk | Tjwa | | dtjwa@umcutrecht.nl | 06-27744381 | | Inclusion criteria: All patients with PCR confirmed COVID-19 with a clinically suspected pulmonary embolism, aged 18 years or over. | Exclusion criteria: chronic and known deep vein thrombosis (DVT), ipsi- or contralateral DVT within the previous 6 months, pregnancy | Pulmonary embolism, deep venous thrombosis, venous thromboembolic disease, COVID-19 | | The percentage of preventable CTPA in the work up of suspected PE in COVID-19 positive patients. | | | | Yes | False | | |
| → | NL8547 | 1 November 2021→15 November 2021 | REDUCING HOSPITAL ADMISSION OF ELDERLY IN SARS-CoV-2 PANDEMIC VIA THE INDUCTION OF TRAINED IMMUNITY BY BACILLUS CALMETTE-GUÉRIN VACCINATION, A RANDOMIZED CONTROLLED TRIAL | REDUCING HOSPITAL ADMISSION OF ELDERLY IN SARS-CoV-2 PANDEMIC VIA THE INDUCTION OF TRAINED IMMUNITY BY BACILLUS CALMETTE-GUÉRIN VACCINATION, A RANDOMIZED CONTROLLED TRIAL | | Radboudumc | 22/04/2020 | 20200422 | Netherlands Trial Register | https://trialregister.nl/trial/8547 | Recruiting | No | | | | 16/04/2020 | 1600 | Interventional |
Randomized: No,
Masking: Single,
Control: Placebo,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Single, <br> Control: Placebo, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Simone | Moorlag | | Simone.Moorlag@radboudumc.nl | +31-24-3667218 | | Inclusion criteria: • Adult (= 60 years) | Exclusion criteria: <br>• Fever (>38 ºC) within the past 24 hours <br>• Suspicion of current active viral or bacterial infection <br>• Expected vaccination during the first three months of the study period<br>• Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any immunosuppressant drugs such as anti-cytokine therapies, and treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks <br>• Active solid or non-solid malignancy or lymphoma within the prior two years<br>• Active participation in another research study that involves BCG administration<br> | COVID-19 | BCG-vaccine | • SARS-CoV-2 related hospital admission | | | | No | False | | |
| → | NL8627 | 1 November 2021→15 November 2021 | Association of BMI with COVID-19 incidence and severity | Association of BMI with COVID-19 incidence and severity | | none | 18/05/2020 | 20200518 | Netherlands Trial Register | https://trialregister.nl/trial/8627 | Not Recruiting | No | | | | 01/03/2020 | 200 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Rutger | Middelburg | | r.a.middelburg@lumc.nl | +31715264037 | | Inclusion criteria: Hospital admission for COVID-19 and tested positive for SARS-Coronavirus 2 by either PCR or CT (CORADS score 5) in the LUMC. | Exclusion criteria: Patients who were suspected for COVID-19 but were tested negative by both 2 negative PCR tests or a CT CORADS score below 4. Patients who opted out for the study. Patients who were transferred to the LUMC for Extracorporeal Life Support. | COVID-19 | | Incidence of COVID-19 (association with BMI) | | | | No | False | | |
| → | NL8633 | 1 November 2021→15 November 2021 | A randomized, double blinded clinical trial of convalescent plasma compared to standard plasma for treatment of hospitalized non-ICU patients with COVID-19 infections | Convalescent plasma compared to standard plasma for treatment of hospitalized non-ICU patients with COVID-19 infections | | Leiden University Medical Center | 13/05/2020 | 20200513 | Netherlands Trial Register | https://trialregister.nl/trial/8633 | Recruiting | No | | | | 13/05/2020 | 430 | Interventional |
Randomized: No,
Masking: Double,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Double, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Jaap Jan | Zwaginga | | j.j.zwaginga@lumc.nl | 0715264006 | | Inclusion criteria: 1. Maximal 3 days hospitalized at plasma infusion. <br>2. Age = 18 years and = 85 years<br>3. SARS-CoV-2 infection: confirmed by PCR (BAL, sputum, nasal and/or pharyngeal swap) not longer than 7 days before.<br>4. Symptoms not expected to lead to IC transfer within 6 hours of study plasma administration<br>5. Written informed consent including storing of specimen for future testing<br> | Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:<br><br>1. Accompanying diseases other than COVID-19 with an expected survival time of less than 6 months<br>2. Chronic severe pulmonary dysfunction like obstructive lung disease (COPD), Gold stage 4; severe emphysema; or lung fibrosis with usual interstitial pneumonia (IUP) pattern <br>3. Chronic heart failure NYHA >= 3 and/or pre-existing reduction of left ventricular ejection fraction to = 30% for which among others e.g. strict fluid restriction is needed <br>4. Clinical diagnosis of circulatory overload for which active therapy (like increased doses of diuretics) is initiated <br>5. Clinical judgement of deterioration in oxygenation (e.g. more than 2 L increase in additonal O2 by nose tube), respiratory rates ( e.g. more than 5 / min increase) in the 2 hours before the planned randomisation / plasma infusion <br>6. Signs of severe coagulopathy : thrombocytopenia by consumption ( <100 x 10e9/l) or prolongation of the PT (+3 sec) , PTT (+ 5 sec) <br>7. Any history of severe adverse reactions to plasma proteins<br>8. Known deficiency of immunoglobulin A<br>9. Pregnancy<br>10. Breastfeeding women<br>11. Psychiatric or cognitive illness or recreational drug/alcohol use that in the opinion of the principal investigator, would affect subject safety and/or compliance<br> | COVID-19 | Enrolled patients will either receive convalescent thawed fresh frozen plasma 1 unit (250-325 ml) (=treatment group) or standard thawed fresh frozen plasma 1 unit (250-325 ml) (=control group) | Ordinal outcome at day 14 of all cause mortality, mechanical ventilation, ICU admission and long duration of hospital stay (6 days or more), with less than 6 hospitalized days as reference category. | | | | Yes | False | | |
| +++ | NL9850 | 15 November 2021 | Transmission of SARS-CoV-2 within Dutch households | Study on COVID-19 cases and their household contacts in the Netherlands using the First Few X (FFX) protocol | | National Institute for Public Health and the Environment (RIVM) | 02/11/2021 | 20211102 | Netherlands Trial Register | https://trialregister.nl/trial/9850 | Not Recruiting | No | | | | 23/03/2020 | 250 | Observational | <br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Inge | Roof | | inge.roof@rivm.nl | +31629649396 | | Inclusion criteria: Any person 16 years and older testing positive for SARS-CoV-2 (index case) who had at least one child in their household below the age of 18 and consented to be contacted for scientific research. Every household contact (persons living in the same house as the index patient) was to be enrolled in the study. | Exclusion criteria: Household contacts below the age of 1. Households were excluded if one or more of the household contacts did not want to participate in the study upfront. | COVID-19, SARS-CoV-2 | Not applicable | To estimate secondary attack rates of SARS-CoV-2 and determine factors that impact susceptibility and infectiousness. | | | | No | False | | |
| → | NL9738 | 1 November 2021→15 November 2021 | Monitor Mentale Gezondheid Medewerkers (Monitoring Mental Health Employees) | Trajectories and Determinants of Mental Health of Hospital Employees after COVID-19 Outbreak in the Netherlands | | OLVG | 20/09/2021 | 20210920 | Netherlands Trial Register | https://trialregister.nl/trial/9738 | Not Recruiting | No | | | | 12/05/2020 | 1000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Anne | Bakker | | Anne.Bakker@olvg.nl | 0205992844 | | Inclusion criteria: Hospital staff OLVG<br>18 years and older | Exclusion criteria: none | N/A | There is no formal intervention testing. Consumption of supportive interventions are recorded by participant self-report. | Trajectories of depression symptoms, assessed with the PHQ-8, and their determinants | | | | No | False | | |
| → | NL8645 | 1 November 2021→15 November 2021 | Sero-surveillance SARS-CoV-2 | Serologic surveillance of SARS-CoV-2 during the 2020 pandemic in exposed and unexposed healthcare workers in an academic hospital in Amsterdam | | Amsterdam UMC | 19/05/2020 | 20200519 | Netherlands Trial Register | https://trialregister.nl/trial/8645 | Recruiting | No | | | | 23/03/2020 | 800 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Jonne | Sikkens | | j.sikkens@amsterdamumc.nl | 0204444444 | | Inclusion criteria: Exposed group: nurses & physicians caring for suspected or confirmed current COVID-19 patients on a COVID-19 unit, ICU or emergency ward.<br>Intermediate group: nurses & physicians caring for patients without suspected or confirmed current COVID-19 (in contrast to the other groups, this group is only measured once)<br>Control group: hospital personnel not working in patient care | Exclusion criteria: Age <18 years old. | COVID-19, humane coronaviruses NL63, 229E, OC43, HKU1 | none | prevalence and time to SARS-CoV-2 seroconversion (IgG and/or IgM) compared between groups. We will test for differences between groups (dichotomous & survival data), assuming a 10% minimally relevant difference. If groups are not statistically different we will use non-inferiority analysis methods to test whether the difference between groups is within the non-inferiority margin of 10%. | | | | No | False | | |
| +++ | NL9859 | 15 November 2021 | Microbiota targeted therapy as alternative for prednisolone and biologicals in IBD patients during the current COVID-19 threat | Microbiota targeted therapy as alternative for prednisolone and biologicals in IBD patients during the current COVID-19 threat: a prospective study addressing the safety of Budesonide in combination with rifaximin or the Nestlé diet | | Nestlé | 23/08/2021 | 20210823 | Netherlands Trial Register | https://trialregister.nl/trial/9859 | Not Recruiting | No | | | | 07/05/2020 | 40 | Observational | <br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Andrea | van der Meulen | | ae.meulen@lumc.nl | 071-5269111 | | Inclusion criteria: IBD patients - 18 years old - in patients where induction therapy is needed - chosen for one of the treatment options (antibiotic treatment or CDED), in consultation with the attending physician. | Exclusion criteria: Severe activity of IBD urging for rescue treatment to avoid surgery, active fistulas as main indication for current induction therapy of CD, pouchitis, signs of active infectious gastro-enteritis/enterocolitis or other signs of infectious agents in stool sample, abnormal renal function (eGFR <30 ml/min), pre-existent leucopenia (<2) or thrombopenia (<50), liver cirrhosis with a MELD score >20, any other condition which in the opinion of the treating physician would make the patient unsuitable for treatment according to this protocol/enrollment. | Inflammatory bowel diseases: ulcerative colitis or Crohn's disease | | The results of this prospective study may result in a safe treatment protocol during future pandemics, in which an alternative of immunosuppressive medication may reappear. | | | | No | False | | |
| → | NL9307 | 1 November 2021→15 November 2021 | Helicopter transport of Critical Care patients with COVID-19 in the Netherlands, hemodynamic changes during actual transport | Helicopter transport of Critical Care patients with COVID-19 in the Netherlands | | none | 10/03/2021 | 20210310 | Netherlands Trial Register | https://trialregister.nl/trial/9307 | Recruiting | No | | | | 23/10/2020 | 50 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Cor | Slagt | | cor.slagt@radboudumc.nl | 0651103437 | | Inclusion criteria: all COVID-19 ventilated intensive care patients transported with LL5 who where monitored with full hemodynamic monitoring. HR, SpO2,AF, ECG, invasive RR, non invasive CO measurements | Exclusion criteria: <br>all COVID-19 ventilated intensive care patients transported with LL5 who where NOT monitored with full hemodynamic monitoring. HR, SpO2,AF, ECG, invasive RR, non invasive CO measurements | Ventilated COVID-19 intensive care patients | none | adverse events with respect to vital signs | | | | No | False | | |
| → | NL8668 | 1 November 2021→15 November 2021 | Lifestyle of pregnant women during COVID-19 pandemic | Lifestyle of pregnant women during COVID-19 pandemic | | Academic Hospital Maastricht | 28/05/2020 | 20200528 | Netherlands Trial Register | https://trialregister.nl/trial/8668 | Not Recruiting | No | | | | 28/05/2020 | 20 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Marijn | Hesselink | | marijn.hesselink@mumc.nl | +31683049082 | | Inclusion criteria: <br>- Female<br>- Older than 18 years of age <br>- Pregnant<br>- Speaking Dutch | Exclusion criteria: There are no exclusion criteria for this study. If inclusion criteria are met, participants can join. | None, condition: pregnant | None | Health behaviour:<br>- Physical activity behaviour<br>- Dietary behaviour<br>- Following courses online (sports, meditation, courses preparing for labour) <br>- Experiences with and appreciation of online tools to improve lifestyle<br>- Experienced stress | | | | Yes | False | | |
| → | NL8710 | 1 November 2021→15 November 2021 | COVID-19 Follow-up care paths and Long-term Outcomes Within the Dutch health care system: a combined rehabilitation, pulmonary, and intensive care perspective | COVID-19 Follow-up care paths and Long-term Outcomes Within the Dutch health care system: a combined rehabilitation, pulmonary, and intensive care perspective | | Erasmus MC | 12/06/2020 | 20200612 | Netherlands Trial Register | https://trialregister.nl/trial/8710 | Recruiting | No | | | | 01/07/2020 | 500 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Majanka | Heijenbrok-Kal | | m.heijenbrok@erasmusmc.nl | +31102412412 | | Inclusion criteria: • COVID-19 diagnosis (based on positive PCR or multidisciplinary team decision based on symptoms and CT or positive serology);<br>• requiring and surviving hospitalization; <br>• within 6 months post hospital discharge; <br>• patient or relative has sufficient knowledge of Dutch or English language.<br> | Exclusion criteria: • age< 18 years;<br>• incapacitated subjects.<br> | COVID-19 | | Pulmonary function, fitness, mobility, physical activity, cognitive function, psychological function | | | | Yes | False | | |
| → | NL8473 | 1 November 2021→15 November 2021 | Immunity against SARS-CoV-2 in Dutch population | Third population-based immune surveillance study used for the evaluation of immunity against SARS-CoV-2 | | National Institute for Public Health and the Environment (RIVM) | 23/03/2020 | 20200323 | Netherlands Trial Register | https://trialregister.nl/trial/8473 | Recruiting | No | | | | 23/03/2020 | 7000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Alienke | Wijmenga-Monsuur | | pienteronderzoek@rivm.nl | NA | | Inclusion criteria: Subject previously participated in the PIENTER 3 study (2016/17) and had indicated that they could be approached for a follow-up study, or Subjects from a random age-stratified sample from the Netherlands | Exclusion criteria: There are no exclusion criteria. | COVID-19, SARS-CoV-2 | Not applicable | To assess achieved immunity against COVID-19 across the different age groups in The Netherlands by testing a representative part of<br>the Dutch population for the presence of SARS-Cov-2 specific antibodies in serum | | | | Yes | False | | |
| → | NL9045 | 1 November 2021→15 November 2021 | Healthy volunteers blood sampling | Screening of the immune repertoire of healthy volunteers for broadly reactive antibodies directed against coronavirus S protein, including SARS-CoV-2 | | Leyden Laboratories B.V. | 12/11/2020 | 20201112 | Netherlands Trial Register | https://trialregister.nl/trial/9045 | Recruiting | No | | | | 03/11/2020 | 20 | Observational |
Randomized: No,
Masking: Single,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: Single, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | I.M.C. | de Visser-Kamerling | | clintrials@chdr.nl | +31 71 5246 400 | | Inclusion criteria: 1. Participant must sign the study informed consent form prior to any study-mandated procedure indicating that he or she understands the purpose, procedures and potential risks, and is willing to participate in the study;<br>2. Participant is male or female and between 40 and 65 years of age, inclusive, at the time of enrollment;<br>3. Participant is willing and able to complete the study procedures;<br>4. Participant has a primary care physician at the time of enrollment;<br>5. Participant is generally healthy in the investigator’s clinical judgment, as determined by medical history evaluation, including no clinically significant disorder, condition, infection or disease that would interfere with the study evaluation, procedures or completion.<br><br> | Exclusion criteria: 1. Participant has current clinical symptoms of COVID-19 (including, but not limited to: cough, fever, shortness of breath, sudden onset of anosmia, ageusia or dysgeusia). Note that a participant who reports a previous positive diagnostic test result for SARS-CoV-2 infection (serological testing or viral RNA detection by PCR testing) and who is recovered from COVID-19 for at least three weeks prior to blood sampling is allowed to participate in the study as deemed by the investigator;<br>2. Participant had recent close contact with a SARS-CoV-2 infected person or someone in their household tested positive for SARS-CoV-2, has travelled to a country/area that has been designated as a COVID-19 risk area according to the effective policies/guidelines of the National Institute for Public Health and the Environment (Dutch: RIVM) or otherwise meet criteria for home isolation;<br>3. Participant received immunosuppressive medication or other immunomodulating agents (including investigational drugs) in the 3 weeks prior to study blood sampling or received immunoglobulins or blood products in the 3 months prior to study blood sampling;<br>4. Participant with a whole blood donation or loss of >500 ml within 21 days before study blood sampling;<br>5. Any known factor, condition, or disease that might interfere with compliance, study conduct or interpretation of the results, as deemed by the investigator.<br><br> | SARS-CoV-2, COVID-19, Corona | None | • B-cell response as assessed by enzyme-linked immunosorbent assay (ELISA) and/or enzyme-linked immunosorbent spot assay (ELISpot) and/or flow cytometry methods<br>• Serology: peptide library scanning<br> | | | | No | False | | |
| → | NL8526 | 1 November 2021→15 November 2021 | Neuroinvasion in COVID-19 | SARS-CoV-2 presence in the cerebrospinal fluid of COVID-19 patients with acute respiratory failure: a pilot study. | | Zuyderland Medical Centre | 14/04/2020 | 20200414 | Netherlands Trial Register | https://trialregister.nl/trial/8526 | Not Recruiting | No | | | | 26/04/2020 | 10 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Floris | Smeets | | fl.smeet@zuyderland.nl | 088 – 459 9717 | | Inclusion criteria: - At least 18 years of age<br>- Requires mechanical ventilation<br>- Proven SARS-CoV-2 infection<br>- Lumbar puncture possible within 48 hours of ICU admission <br>- Informed consent provided by either patient or legal representative | Exclusion criteria: - Contraindication for lumbar puncture<br>- Proven or suspected cerebrospinal fluid leak or other blood-brain barrier defects <br>- Any condition known to alter cerebrospinal fluid biochemistry<br>- Known or suspected cause for respiratory failure, other than COVID-19<br>- Any disease known for decreasing pulmonary capacity or compliance <br> | COVID-19 | | SARS-CoV-2 RT-PCR of cerebrospinal fluid | | | | Yes | False | | |
| → | NL9320 | 1 November 2021→15 November 2021 | Remote Early Detection of SARS-CoV-2 infections | Remote Early Detection of SARS-CoV-2 infections | | Universitair Medisch Centrum Utrecht (UMCU), Julius Center | 18/02/2021 | 20210218 | Netherlands Trial Register | https://trialregister.nl/trial/9320 | Not Recruiting | No | | | | 25/02/2021 | 20000 | Interventional |
Randomized: No,
Masking: Single,
Control: Not applicable,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Single, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Pieter | Stolk | | p.stolk@umcutrecht.nl | +31624214271 | | Inclusion criteria: • Resident of the Netherlands<br>• At least 18 years old<br>• Informed consent provided (electronic)<br>• Willing to adhere to the study procedures described in this protocol<br>• Must have a smartphone that runs at least Android 8.0 or iOS 13.0 operating systems and is active for the duration of the study (in the case of a change of mobile number, study team should be notified)<br>• Be able to read, understand and write Dutch | Exclusion criteria: • Previous positive SARS-CoV-2 test result (confirmed either through PCR/antigen or antibody tests) (self-reported)<br>• Previously received a vaccine developed specifically for COVID-19 or in possession of an appointment for vaccination in the near future<br>• Current suspected (e.g. waiting for test result) coronavirus infection or symptoms of a coronavirus infection (self-reported)<br>• Participating in any other COVID-19 clinical drug, vaccine, or medical device trial<br>• Electronic implanted device (such as a pacemaker)<br>• Pregnant at time of informed consent (self-reported)<br>• Suffering from cholinergic urticaria (per the Ava bracelet’s User Manual)<br>• Staff involved in the management or conduct of this study<br> | COVID-19 | Ava COVID-RED app and the Ava bracelet | SARS-CoV-2 infection (as confirmed through a positive PCR/antigen or serology test) | | | | Yes | False | | |
| → | NL8685 | 1 November 2021→15 November 2021 | COVID-19 in professional soccer players (COPROS study) | COVID-19 in professional soccer players (COPROS study) | | KNVB | 10/05/2020 | 20200510 | Netherlands Trial Register | https://trialregister.nl/trial/8685 | Recruiting | No | | | | 18/05/2020 | 140 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Jan | Kluytmans | | jankluytmans@gmail.com | 0765952060 | | Inclusion criteria: A subject who meets all of the following criteria will be eligible to participate in this study:<br>• PSPs and staff members in one of the participating soccer clubs<br> | Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:<br>• Age below 18 years<br>• Direct involvement in the design or execution of this study<br>• Legally incapacitated or unwilling to provide informed consent<br> | COVID-19 | none | • To determine the cumulative incidence of SARS-CoV-2 (re)infection, measured by semi-quantitative real-time reverse transcriptase PCR (sqRT-PCR) in PSPs with self-reported symptoms suspected for COVID-19 during follow-up. | | | | Yes | False | | |
| → | NL8694 | 1 November 2021→15 November 2021 | Prospective diagnosis of Covid-19 ïnfectionusing exhaled breath analysis by electronic nose | Prospective diagnosis of Covid-19 ïnfection using exhaled breath analysis by electronic nose | | LUMC | 10/06/2020 | 20200610 | Netherlands Trial Register | https://trialregister.nl/trial/8694 | Recruiting | No | | | | 17/04/2020 | 200 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Geert | Groeneveld | | g.h.groeneveld@lumc.nl | 0715269111 | | Inclusion criteria: All newly presented individuals (>18 years of age) and health care personnel with a<br>suspected diagnosis of Covid-19 infection. | Exclusion criteria: - Recent (< 12 hours) intake of alcohol;<br>- Unwillingness or inability to comply with the study protocol for any other reason. | COVID | None | Primary Objectives:<br>To determine the diagnostic accuracy of exhaled breath analysis by eNose at point of care<br>for discrimination between healthy controls and individuals with respiratory symptoms with<br>and without a Covid-19 infection.<br> | | | | No | False | | |
| → | NL8714 | 1 November 2021→15 November 2021 | The impact of COVID-19 among illiterate people and people with a mild intellectual disabilities: preventative measures, (mental) health and support needs | The impact of COVID-19 among illiterate people and people with a mild intellectual disabilities: preventative measures, (mental) health and support needs | | ZonMw, GGD Gelderland-Midden, GGD Gelderland-Zuid | 12/06/2020 | 20200612 | Netherlands Trial Register | https://trialregister.nl/trial/8714 | Not Recruiting | No | | | | 01/08/2020 | 1000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Monique | Koks-Leensen | | Monique.Koks-Leensen@radboudumc.nl | 0243618181 | | Inclusion criteria: Dutch adults (18 yr or older) that have either low literacy skills and/or a mild intellectual disabilty | Exclusion criteria: Younger than 18 years of age | illiteracy, mild intellectual disability, mental health | | mental health | | | | Yes | False | | |
| → | NL8726 | 1 November 2021→15 November 2021 | Effect of hydroxychloroquine treatment on the general immunocompetence | Randomized, placebo-controlled multiple dose study to evaluate the effect of hydroxychloroquine on the general immuno-competence in young and elderly healthy male volunteers | | CHDR | 23/06/2020 | 20200623 | Netherlands Trial Register | https://trialregister.nl/trial/8726 | Recruiting | No | | | | 01/06/2020 | 40 | Interventional |
Randomized: No,
Masking: Single,
Control: Placebo,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: Single, <br> Control: Placebo, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | M. | Moerland | | clintrials@chdr.nl | +31 71 5246 400 | | Inclusion criteria: 1. Healthy male subjects, 18 to 30 years or 65 to 70 years of age, inclusive at screening. <br>2. Body mass index (BMI) between 18 and 28 kg/m2, inclusive, and with a minimum weight of 50 kg.<br>3. Has the ability to communicate well with the Investigator in the Dutch language and willing to comply with the study restrictions | Exclusion criteria: 1. Known hypersensitivity reaction to chloroquine, hydroxychloroquine or 4-aminoquinolines;<br>2. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator, following a detailed medical history (including a known history of long QT syndrome, known history of retinal disease, G6PD deficiency, porphyria, psoriasis, myasthenia gravis, liver disease, diabetes mellitus type I and II, existing hearing loss, and current or revious history of a relevant psychiatric disorder ie. major depressive disorder, bipolar disorder, schizophrenia or another psychotic disorder or current of previous suicidality irrespective of an associated psychiatric disorder);<br>3. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis). In the case of uncertain or questionable results, tests performed during screening may be repeated before randomization to confirm eligibility or judged to be clinically irrelevant for healthy subjects;<br>4. Signs or symptoms of any active infection within two weeks prior to first dosing.<br>5. Positive SARS-CoV-2 qPCR test pre-dose.<br>6. Positive Hepatitis B surface antigen (HBsAg), Hepatitis C antibody (HCV Ab), or human immunodeficiency virus antibody (HIV Ab) at screening;<br>7. Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg and considered to be of clinical relevance by the investigator;<br>8. Abnormal findings in the resting ECG, including but not limited to QTcF> 450 msec.<br>9. Use of any medications (prescription or over-the-counter [OTC]), within 14 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions will only be made if the rationale is clearly documented by the investigator;<br>10. Participation in an investigational drug study (last dosing of previous study was within 90 days prior to first dosing of this study);<br>11. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 14 units alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillizers, or any other addictive agent and unable to abstain from alcohol use from at least 24 hours before every visit;<br>12. Positive test for drugs of abuse at screening or pre-dose. Drugs test may be repeated;<br>13. Smoker of more than 10 cigarettes per week prior to screening or who use tobacco products equivalent to more than 10 cigarettes per week and unable to abstain from smoking from at least 7 days before first dosing until the last return visit (day 10);<br>14. Any confirmed significant allergic reactions (urticaria or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable);<br>15. Loss or donation of blood over 500 mL within three months prior to screening or intention to donate blood or blood products during the study;<br>16. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease. | COVID19 | 6 x 400 mg Hydroxychloroquine sulphate or placebo | Pharmacokinetic endpoints<br>- Hydroxychloroquine plasma concentration<br>- Hydroxychloroquine whole blood concentration <br><br>Pharmacodynamic endpoints<br>- Endosomal TLR responses<br>o TLR3-driven cytokine production <br>o TLR7-driven cytokine production<br>o TLR8-driven cytokine production<br>o TLR9-driven cytokine production<br>- T cell responses<br>o Proliferation <br>o Activation marker expression<br>o Cytokine production <br>- B cell responses<br>o Activation marker expression<br>o Proliferation<br>- Leukocyte differentiation <br>- Flow cytometry phenotyping of dendritic cells, monocytes, T cells and B cells | | | | No | False | | |
| → | NL8729 | 1 November 2021→15 November 2021 | Primary care Research on Outcomes of COVID-19 | What are the long-term consequences of more severe COVID-19 infections (complicated respiratory tract infections), in patients managed in general practice, physically as well as psychologically and what are the risk factors of a worse outcome of disease (protracted signs and symptoms, unfavorable impact on daily activities)? | | UMC Utrecht | 26/06/2020 | 20200626 | Netherlands Trial Register | https://trialregister.nl/trial/8729 | Not Recruiting | No | | | | 01/08/2020 | 274 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Tamara | Platteel | | t.n.platteel-3@umcutrecht.nl | +318875 680 54 | | Inclusion criteria: Patients at least 18 years of age, with a history of a complicated respiratory tract infection, between March 1st and June 1st 2020 in primary care, who were not admitted to the hospital. | Exclusion criteria: Patients with a life expectancy of <1 year, patients who were hospitalized in the previous 14 days before the index consultation at the COVID-19 centre, patients not capable of performing telephone interviews, patients who were hospitalised within 14 days after the index consultation. | complicated respiratory tract infections, COVID-19 | n.a. | Quality of life (SF-36) | | | | Yes | False | | |
| → | NL9334 | 1 November 2021→15 November 2021 | Safety and tolerability of ABNCoV2 | First-in-human trial of the Coronavirus virus-like particle subunit vaccine ABNCoV2 in SARS-CoV-2-naïve adult volunteers in good health | | Stichting Radboud universitair medisch centrum | 10/03/2021 | 20210310 | Netherlands Trial Register | https://trialregister.nl/trial/9334 | Recruiting | No | | | | 11/03/2021 | 42 | Interventional |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Merel | Smit | | merel.smit@radboudumc.nl | 024-3619515 | | Inclusion criteria: 1. Subject must sign written informed consent to participate in the trial.<br>2. Subject is able to understand planned study procedures and demonstrate comprehension of the protocol procedures and knowledge of the study by passing a quiz (assessment of understanding). Subjects must score at least 80% correct on a multiple-choice quiz. If they do not score 80% on the initial quiz, the protocol information will be reviewed with them, and they will have the opportunity to retest.<br>3. In the opinion of the investigator, the subject can and will comply with the requirements of the protocol.<br>4. Subjects are available to attend all study visits and are reachable by phone throughout the entire study period from day -1 until 24 weeks following last vaccination (end of study).<br>5. Subject is a male or non-pregnant and non-lactating female age = 18 and = 55 years and in good health at time of ABNCoV2 administration.<br>6. Subject agrees to their general practitioner (GP) being informed about participation in the study and agrees to sign a form to request the release by their GP, and medical specialist when necessary, of any relevant medical information concerning possible contra-indications for participation in the study to the investigator(s).<br>7. The subject agrees to refrain from blood donation to Sanquin or for other purposes throughout the study period according to current Sanquin guidelines.<br>8. Female subjects of non-childbearing potential may be enrolled in the study. Non-childbearing potential is defined as pre-menarche, current bilateral tubal ligation or occlusion, hysterectomy, bilateral ovariectomy or post-menopause. All other female subjects must agree to use continuous adequate contraception2 for the duration of the study. Female subjects must have a negative pregnancy test at the inclusion visit. | Exclusion criteria: 1. Any clinically significant abnormal finding on clinical examination or laboratory screening tests according to the US Food and Drug Administration (FDA) Toxicity Grading Scale for Healthy Adult and Adolescent Subjects Enrolled in Preventative Vaccine Clinical Trials [30].<br>2. History of COVID-19 infection.<br>3. Chronic use of immunosuppressive drugs or other immune modifying drugs within six months prior to study onset (inhaled and topical corticosteroids and oral anti-histamines exempted) or expected use of such during the study period.<br>4. Positive urine toxicology test for cannabis, cocaine or amphetamines at inclusion.<br>5. Screening tests positive for SARS-CoV-2, SARS-CoV-2 antibodies, Human Immunodeficiency Virus (HIV), active Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV).<br>6. Receipt of any investigational or non-registered product (drug or vaccine) other than the study product in the 30 days preceding enrolment or during the study period.<br>7. Participation in any other clinical study in the 30 days prior to the start of the study or during the study period.<br>8. Immunization with any vaccines within the past four weeks or planned receipt of a vaccine during the study period with the exception of a licensed SARS-CoV-2 vaccine, given within the framework of the national SARS-CoV-2 vaccination campaign. The time between last vaccination with ABNCoV2 and a SARS-CoV-2 vaccine provided by the campaign shall be at least 4 weeks.<br>9. Known hypersensitivity to any of the vaccine components (adjuvant or protein).<br>10. Administration of immunoglobulins and/or any blood products within the three months prior to the first dose of ABNCoV2 or planned administration during the study period.<br>11. Previous participation in a COVID-19 vaccine study.<br>12. Body Mass Index (BMI) >35 kg/m2.<br>13. Pregnancy, lactation or intention to become pregnant during the study period.<br>14. History of drug or alcohol abuse interfering with normal functioning in the five years preceding enrolment.<br>15. Being an employee or student of the department of Medical Microbiology of the Radboudumc, or a person otherwise related to the investigator other than a professional relationship for clinical trial purpose only.<br>16. Any other condition or situation that would, in the opinion of the investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol. | SARS-CoV-2, COVID-19 | The trial involves first-in-human administration, pre-defined, sequential dose escalation of ABNCoV2, and adjuvant selection. | Primary safety endpoint: Number of at least possibly related Grade 3 adverse events (AE) and serious adverse events (SAE) from time of first administration of ABNCoV2 until the end of the follow-up period.<br>Primary immunogenicity endpoint: Concentration of ABNCoV2-specific antibodies 14 days following first vaccination. | | | | Yes | False | | |
| → | NL8733 | 1 November 2021→15 November 2021 | SARS-CoV-2 immune response in asymptomatic patients | SARS-CoV-2 immune response in asymptomatic patients | | Amsterdam UMC, location AMC | 11/06/2020 | 20200611 | Netherlands Trial Register | https://trialregister.nl/trial/8733 | Recruiting | No | | | | 01/06/2020 | 75 | Observational |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Annemieke | van den Broek | | a.k.vandenbroek@amc.uva.nl | +31 20 566 6807 | | Inclusion criteria: - Adult (age = 18 years)<br>- Screened for COVID-19 according to the national guidelines because of a planned surgical or interventional procedure under general anesthesia.<br>- Tested positive for SARS-CoV-2 with RT-PCR.<br>- Asymptomatic at the moment of screening: no suspicion for COVID-19 for at least 48 hours prior to screening, based on a standardized questionnaire containing the following complaints: cough, dyspnoea, fever, general malaise, myalgia, headache, extreme fatigue (new onset), throat ache, obstructed/runny nose, loss of smell, loss of taste, abdominal pain, diarrhoea and vomiting.<br> | Exclusion criteria: - Not able or willing to give informed consent. | SARS-CoV-2 | | The primary objective is to determine the quantity and quality of antibody and T-cell responses to SARS-CoV-2 in asymptomatic patients who tested positive for SARS-CoV-2 with RT-PCR prior to interventions. | | | | No | False | | |
| → | NL8735 | 1 November 2021→15 November 2021 | Risk of infection with SARS-CoV-2 amongst physicians | The Incidence of COVID-19 in Healthcare Personnel Performing Aerosol Generating Procedures: an Observational Study (COVID-AGP) | | Amsterdam University Medical Center, location AMC and University Medical Center Utrecht (UMCU) | 16/06/2020 | 20200616 | Netherlands Trial Register | https://trialregister.nl/trial/8735 | Not Recruiting | No | | | | 16/06/2020 | 3000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Jennifer | Breel | | j.s.breel@amsterdamumc.nl | 0610019257 | | Inclusion criteria: Any physician in the following specialities, working in the Netherlands, during the COVID-19 outbreak (anesthesiologists, internal medicine, intensive care medicine, surgeons, pulmonologists, rehabilitation doctors and psychiatrists). | Exclusion criteria: None | COVID-19 | None,documentation of self-reported symptoms and PCR testing | Incidence of doctors with positive PCR test for COVID-19 | | | | Yes | False | | |
| → | NL8490 | 1 November 2021→15 November 2021 | An open label randomized controlled trial of chloroquine, hydroxychloroquine or only supportive care in patients admitted with moderate to severe COVID-19
| An open label randomized controlled trial of chloroquine, hydroxychloroquine or only supportive care in patients admitted with moderate to severe COVID-19
| | UMC Utrecht | 31/03/2020 | 20200331 | Netherlands Trial Register | https://trialregister.nl/trial/8490 | Not Recruiting | No | | | | 12/04/2020 | 950 | Interventional |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Jesper | Weehuizen | | j.m.weehuizen-2@umcutrecht.nl | 0887555678 | | Inclusion criteria: - Patients (=18 years of age) admitted to the hospital with confirmed COVID-19 and not needing admission to MC or ICU<br>- Patient has moderate to severe COVID-19. This will be defined as patients with NEWS-2 score = 5. <br>- Willing and able to give written informed consent | Exclusion criteria: - Severe Covid-19 defined as NEWS-2 score >5 or admission to the ICU needing ventilation or pressure support. <br>- Contra-indications for hydroxychloroquine or chloroquine<br>- Known pregnancy, not using adequate contraception and having a chance of being pregnant (unless a negative pregnancy test is documented) or breast-feeding<br>- Unable to take oral medication (chloroquine and hydroxychloroquine can be administered through tube feeding and is considered oral administration)<br>- Identified allergies to 4-aminoquinoline<br>- Severe diseases of the blood system <br>- 6-phosphate dehydrogenase deficiency <br>- History of acute myocardial infarction, unstable angina pectoris, severe arrhythmia (frequent ventricular, ventricular tachycardia, ventricular fibrillation) in recent 6 months; New York Heart Association (NYHA) level III-IV<br>- Corrected QT interval (QTc) = 480ms on baseline electrocardiogram. (The treatment guideline states: An electrocardiogram is made before start chloroquine and hydroxychloroquine)<br>- Uncorrected severe hypokalaemia (< 2,5 mmol/l) or uncorrected severe hypomagnesemia (< 0.6 mmol/l) <br>- Pancreatitis<br>- Concomitant medication that affect drug absorption, metabolism and excretion, that can induce QT interval prolongation: <br>o Amiodarone, disopyramide, flecainide, ibutailide, kinidine, sotalol, <br>o chlorpromazine, citolapram, escitalopram, haloperidol, pimozide, <br>o azitromycine, claritromycine, erytromycine, moxifloxacine, trimethoprim/sulfamethoxazole, <br>o Dimperidon, ondansetron,<br>o Methadon, <br>o Anagrelide, arseentrioxide, droperidol, pentamidine, sevofluraan, vandetanib. <br>- Refusal to participate expressed by patient or legally authorized representative if they are present <br> | COVID-19 | All treatment arms contain standard supportive care during hospital and:<br>1. Chloroquine arm: loading dose 600mg as chloroquine base followed by 300mg 12 hours later followed by 300mg twice a day; total treatment duration 5 days (same dose as LCI guideline) <br>2. Hydroxychloroquine arm: loading dose 400mg bid followed by 200mg twice a day; total treatment duration 5 days (same dose as LCI guideline)<br>3. No antiviral treatment arm | - Composite endpoint with disease progression defined as a NEWS2score = 7 within 14 days or resulting in admission to Intensive/Medium Care unit or resulting in death within 14 days. | | | | Yes | False | | |
| → | NL8538 | 1 November 2021→15 November 2021 | Sleep position related to hospital length of stay in admitted COVID-19 patients | Sleep position related to hospital length of stay in admitted COVID-19 patients | | None. | 17/04/2020 | 20200417 | Netherlands Trial Register | https://trialregister.nl/trial/8538 | Not Recruiting | No | | | | 17/04/2020 | 342 | Interventional |
Randomized: No,
Masking: None,
Control: Placebo,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Placebo, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Vivan | Baggen | | v.baggen@erasmusmc.nl | 0651696541 | | Inclusion criteria: - Age = 18 years<br>- Admitted to one of our COVID-19 cohort units<br>- PCR confirmed COVID-19<br>- Any form of oxygen therapy (nasal cannula or high-flow nasal oxygen)<br>- Able to independently change from supine to non-supine position<br>- Able to read and speak in the Dutch language<br>- Signed informed-consent<br>- No current indication for mechanical ventilation | Exclusion criteria: - ‘Do not intubate’ order | COVID-19 | Prevent a supine position during sleep by the use of a Sleep Position Trainer, a small wearable device that trains patients to not sleep on their back by using gentle vibrations (1:1 randomization). In both groups sleep position will be continuously registered. | Hospital length of stay (days). | | | | Yes | False | | |
| → | NL8765 | 1 November 2021→15 November 2021 | PULmonary DAMage after hospitalization for acute COvid-19 (PULDAMCO), an exploratory prospective cohort study | PULmonary DAMage after hospitalization for acute COvid-19 (PULDAMCO), an exploratory prospective cohort study | | Radboudumc | 07/07/2020 | 20200707 | Netherlands Trial Register | https://trialregister.nl/trial/8765 | Recruiting | No | | | | 07/07/2020 | 150 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Bram | van den Borst | | bram.vandenborst@radboudumc.nl | 024-3611111 | | Inclusion criteria: ? Hospital admission for COVID-19<br>? CT during admission with CO-RADS >=3<br>? Informed consent | Exclusion criteria: ? Age < 18<br>? Pregnancy<br>? Renal failure (MDRD < 30 ml/kg/1,73m^2)<br>? Allergic reaction to iodine containing intravenous contrast media | COVID-19 | CT angiography at 3 months and chest CT low dose at 12 months after acute COVID-19 infection | -Prevalence of residual lung damage (per type) at 3 and 12 month<br>-Estimated percentage of lung parenchyma affected by various types of diffuse lung damage (e.g., ground glass, consolidation, perfusion abnormalities)<br>-Number of lung segments affected by focal lung damage (e.g., traction bronchiectasis, residual lung emboli)<br>-Predictors of pulmonary damage after acute COVID-19 | | | | Yes | False | | |
| → | NL8787 | 1 November 2021→15 November 2021 | COVID-VTE follow-up study | Incidence and impact of post-VTE syndromes in patients with COVID-19 | | LUMC | 21/07/2020 | 20200721 | Netherlands Trial Register | https://trialregister.nl/trial/8787 | Recruiting | No | | | | 01/06/2020 | 400 | Interventional |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Erik | Klok | | f.a.klok@LUMC.nl | (071) 526 91 11 | | Inclusion criteria: All patients with PCR proven COVID-19 diagnosed with VTE in the participating centers, who has survived the initial 3-month follow-up | Exclusion criteria: None | Venous thrmoboembolism | Application of the patient pathway as recommended in the Dutch guideline | Establish the rate of thrombus resolution and the incidence of post-VTE syndromes in COVID-19 survivors diagnosed with and treaded for VTE, in the perspective of historical Dutch VTE controls from the pre-COVID-19 era. | | | | No | False | | |
| → | NL9081 | 1 November 2021→15 November 2021 | Early@home | Telemedicine for recovering COVID-19 patients | | None | 30/11/2020 | 20201130 | Netherlands Trial Register | https://trialregister.nl/trial/9081 | Not Recruiting | No | | | | 11/01/2021 | 62 | Interventional |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Harriët | van Goor | | h.m.r.vangoor-3@umcutrecht.nl | 0887567967 | | Inclusion criteria: - The patient is in the recovery phase of COVID-19 and receives low flow oxygen therapy or no oxygen therapy <br>- The patient is 18 years of age or older;<br>- The patient is admitted to the hospital with COVID-19 pneumonia;<br>- The patient is expected to be discharged home;<br>- A partner/primary caregiver is available at the patients home for support;<br>- A rectal thermometer is available;<br>- The patient is in possession of a smartphone with the ability to host the Luscii app;<br>- The patient or the caregiver is able to use the smartphone and Luscii app;<br>- The patient or the caregiver is able to use the pulse oximeter;<br>- The patient or the caregiver is able to speak, read and understand the Dutch language sufficiently enough to be able to use the Luscii app;<br> | Exclusion criteria: - A patient with dementia or severe psychiatric disorder who is unlikely to be compliant to the intervention (to be determined by treating physician); <br>- A patient who is discharged to a care facility or rehabilitation center;<br>- A patient who needs more medical support than can be organized at home.<br> | COVID-19 | Relocated hospital care with telemedicine | Days alive at home 30 days after randomization | | | | Yes | False | | |
| → | NL9354 | 1 November 2021→15 November 2021 | Intranasal Ampligen in healthy volunteers. | A Phase I, Randomized, Double-Blind, Placebo-controlled, Placebo-Controlled Study to Evaluate the Safety and Activity of Repeated Intranasal Administration of Ampligen® (Poly I:Poly C12U) in Healthy Subjects | | AIM ImmunoTech Inc. | 23/03/2021 | 20210323 | Netherlands Trial Register | https://trialregister.nl/trial/9354 | Recruiting | No | | | | 17/02/2021 | 40 | Interventional |
Randomized: No,
Masking: Double,
Control: Placebo,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Double, <br> Control: Placebo, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | M. | Moerland | | clintrials@chdr.nl | +31 71 5246 400 | | Inclusion criteria: 1. Signed informed consent prior to any study-mandated procedure;<br>2. Male or female subjects, 18 to 70 years of age, inclusive at screening;<br>3. Body mass index (BMI) between 18 and 32 kg/m2, inclusive at screening, and with a minimum weight of 50 kg.<br>4. Participant must be healthy, in the investigator’s clinical judgment, as confirmed by medical history, physical examination, vital signs, ECG and laboratory assessments performed at screening;<br>5. Willing to comply with effective contraception during the study if subject is male or women of child bearing potential, up to 90 days after the last dose of study treatment.<br>6. Has the ability to communicate well with the investigator in the Dutch language and willing to comply with the study restrictions | Exclusion criteria: 1. Evidence of any active or chronic disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would pose an unacceptable risk to the subject in the opinion of the investigator;<br>2. Clinically significant abnormalities, as judged by the investigator, in laboratory test results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis);<br>3. Positive hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV ab), or human immunodeficiency virus antibody (HIV ab) at screening;<br>4. Respiratory tract infection (including flu and common cold symptoms) or any febrile illness (>38°celsius) in the period of 3 days before first treatment administration;<br>5. Presence of respiratory viral infection as determined by respiratory panel on nasal swab at baseline (including positive SARS-CoV-2 PCR test);<br>6. History of chronic respiratory diseases (e.g. chronic obstructive pulmonary disease, emphysema, chronic rhinitis or sinusitis, asthma or other reactive airway diseases) in adulthood. Childhood asthma and non-active allergic rhinitis (including hay fever) will be permitted at the discretion of the investigator;<br>7. History of frequent nose bleeds;<br>8. Significant anatomical nasal abnormalities or other nasal abnormalities that might impact the study executions (including, but not limited to, nasal septal defects, cleft palate, nasal polyps, previous nasal cautery or surgery that impacts study assessments);<br>9. Immunocompromised (known or expected immune deficiency, disease, or use of medication that may affect the immune system) or evidence of autoimmune disorder (deemed clinically relevant by the investigator);<br>10. Participation in an investigational drug or device study (last dosing of previous study was within 90 days or 5 half-lives prior to first dosing of this study);<br>11. History of abuse of addictive substances (alcohol, illegal substances) or current use of more than 21 units of alcohol per week, drug abuse, or regular user of sedatives, hypnotics, tranquillisers, or any other addictive agent;<br>12. Positive test for drugs of abuse at screening or pre-dose. Drugs test may be repeated;<br>13. A routine smoker of tobacco products, currently or in the past year. No (incidental) smoking will be allowed in the two weeks prior to first dosing;<br>14. Use of immunomodulatory drug; including systemic corticosteroids as well as nasal preparations within 30 days before first dosing;<br>15. Receipt of any vaccine within 1 week prior to IMP administration, or planning to get vaccinated during the study;<br>16. Therapy with interferons, interleukins, or other cytokines within 6 weeks of first dosing;<br>17. Known hypersensitivity to Ampligen or its excipients;<br>18. If a woman, pregnant, or breast feeding, or planning to become pregnant during the study;<br>19. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.<br>20. History of Bell’s Palsy or other forms of facial paralysis.<br>21. Loss or donation of blood over 500 mL within three months (males) or four months (females) prior to screening, or donation of plasma within 14 days of screening or intention to donate blood or blood products during<br>the study | SARS-CoV-2, COVID-19, Corona | Ampligen intranasally via a nasal sprayer<br>Placebo | • To assess the safety and tolerability of Ampligen administered intranasally in a dosing schedule for 13 days (7 doses) in healthy<br>subjects.<br>• To characterize the mucosal immune response following Ampligen administration over time. | | | | No | False | | |
| → | NL8775 | 1 November 2021→15 November 2021 | Postcorona care | Evaluation of long term sequelae after hospital admission with SARS-CoV-2 infection | | none | 13/07/2020 | 20200713 | Netherlands Trial Register | https://trialregister.nl/trial/8775 | Recruiting | No | | | | 13/07/2020 | 90 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Geert | Groeneveld | | g.h.groeneveld@lumc.nl | 0715269111 | | Inclusion criteria: Patients in post COVID outpatient follow up | Exclusion criteria: none | COVID | none | inflammatory response, functional decline, pulmonary fibrosis, lung function abnormalities, cardiac dysfunction and/or psychological sequelae | | | | Yes | False | | |
| → | NL8818 | 1 November 2021→15 November 2021 | Preparations of Dutch Emergency Departments for the SARS-COV-2 outbreak | Preparations of Dutch Emergency Departments for the SARS-COV-2 outbreak | | None | 03/08/2020 | 20200803 | Netherlands Trial Register | https://trialregister.nl/trial/8818 | Recruiting | No | | | | 29/07/2020 | 84 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Rory | O'Connor | | r.oconnor@zuyderland.nl | 088-4592801 | | Inclusion criteria: Dutch Emergency Department | Exclusion criteria: None | COVID-19 | None | Overview of measures taken in preparation for COVID-19 | | | | No | False | | |
| → | NL8821 | 1 November 2021→15 November 2021 | In vitro characterization of the immune response of recovered COVID-19 patients and healthy controls to SARS-CoV-2 | Recovered COVID-19 patients: blood sampling | | ISA Pharmaceuticals B.V. | 07/08/2020 | 20200807 | Netherlands Trial Register | https://trialregister.nl/trial/8821 | Not Recruiting | No | | | | 10/08/2020 | 14 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | I.M.C. | de Visser-Kamerling | | clintrials@chdr.nl | +31 71 5246 400 | | Inclusion criteria: Inclusion criteria for both recovered COVID-19 patients and healthy participants<br>1. Participant must sign the study informed consent form prior to any study-mandated procedure indicating that he or she understands the purpose, procedures and potential risks, and is willing to participate in the study;<br>2. Participant is male or female and between 18 and 65 years of age, inclusive, at the time of enrollment;<br>3. Participant is willing and able to complete the study procedures;<br>4. Participant has a primary care physician at the time of enrollment;<br>5. Participant is not taking any immunosuppressive medication or other immunomodulating agents (including investigational drugs) for at least 3 weeks prior to study blood sampling. <br>Inclusion criteria for recovered COVID-19 patients only <br>1. Participant reports a previous positive diagnostic test result for SARS-CoV-2 infection (serological testing or viral RNA detection by PCR testing); <br>2. Participant had clinical symptoms of COVID-19 (including, but not limited to: cough, fever, shortness of breath, sudden onset of anosmia, ageusia or dysgeusia). The diagnosis of COVID-19 must be the most plausible cause of the reported symptoms, as deemed by the study physician; <br>3. Participant has recovered from COVID-19 for at least three weeks prior to study blood sampling (residual symptoms such as, but not limited to, fatigue and reduced exercise tolerance - that would not jeopardize study endpoints - are allowed at the investigator’s discretion). <br>Inclusion criteria for healthy participants only<br>1. Participant is generally healthy in the investigator’s clinical judgment, as determined by medical history evaluation, including no clinically significant disorder, condition, infection or disease that would interfere with the study evaluation, procedures or completion.<br> | Exclusion criteria: Exclusion criteria for both recovered COVID-19 patients and healthy participants<br>1. Participant with a whole blood donation or loss of >500 ml within 21 days before study blood sampling;<br>2. Any known factor, condition, or disease that might interfere with compliance, study conduct or interpretation of the results, as deemed by the investigator.<br>Exclusion criteria for healthy participants only<br>1. Participant reports a previous positive diagnostic test result for SARS-CoV-2 infection (serological testing or viral RNA detection by PCR testing);<br>2. Participant developed clinically overt symptoms of COVID-19 following close contact with a proven SARS-CoV-2 positive patient, but was not tested (e.g. due to limited test capacity and regulations at that time); <br>3. Participant who is currently working, or has worked in an occupation with a high risk of exposure to SARS-CoV-2 (e.g. health care worker).<br> | COVID-19 | None | Memory T cell response as assessed by interferon-? enzyme-linked immune absorbent spot (ELISpot) assay and/or enzyme-linked immunosorbent assay (ELISA) and intracellular cytokine staining (ICS) | | | | Yes | False | | |
| → | NL9365 | 1 November 2021→15 November 2021 | Behavioural interventions to increase test uptake and self-isolation compliance during Covid-19 community test pilots in the Netherlands: four population-level randomised control trials. | Behavioural interventions to increase test uptake and self-isolation compliance during Covid-19 community test pilots in the Netherlands: four population-level randomised control trials. | | Het Ministerie van Volksgezondheid, Welzijn en Sport | 25/03/2021 | 20210325 | Netherlands Trial Register | https://trialregister.nl/trial/9365 | Recruiting | No | | | | 08/02/2021 | 25644 | Interventional |
Randomized: No,
Masking: Single,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Single, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Marijn | de Bruin | | Marijn.de.Bruin@rivm.nl | 0650185526 | | Inclusion criteria: Testing trials: One invitation letter per household was sent to all residents of Dronten and Bunschoten. In the invitation letter, all residents aged 12 and above in Dronten, and aged 6 and above in Bunschoten were invited to partake in the community-wide testing pilot. <br><br>Self-Isolation support trials: All residents of Dronten and Bunschoten with a positive test result for covid-19 received care as usual during the six week pilot period, and were invited to partake in the trial. In Bunschoten, close patient contacts at risk of Covid-19, were also invited to partake. Intervention materials developed for the trial only offered to patients aged 16 and above due to legal requirements. In case of patients under the age of 16, intervention materials were offered to the household. Intervention materials were, under those circumstances, also addressed ‘parent(s) of’ the minor in the household. Only participants with insufficient written and spoken knowledge of the Dutch language were unable to participate in the trials. | Exclusion criteria: Testing trials: No exclusion applied to participation, but data was only shared for residents aged 12 and above in Bunschoten. This was because a different set of methods was used to test participants aged 6-12 for Covid-19. <br>We will only exclude a subject from which the district the subject is living or the condition the subject is assigned to is missing. If the condition a subject belongs to, or the district a subject lives in is missing, this subject will be excluded from the analysis.<br><br>Self-Isolation support trials: No exclusions were applied to receive self-isolation care as usual. | Covid-19 | 1. RCT 1 Test Dronten - <br> a) IV1: Locality of test sites, two levels: participants have a local testing facility (Swifterbant, intervention) or not (Biddinghuizen, control). <br> b) IV2: Invitation and reminder letters, two levels: participants receive a letter written by the local council (control letter) or adjusted to reflect behavioural determinants (intervention).<br><br>2. RCT 2 Test Bunschoten - <br> a) IV1: Locality and mobility of test site using a testbus between two boroughs, two levels: mobile testing facility absent (control), mobile testing facility present (intervention). <br> b) IV2: Invitation and reminder letters, two levels: participants receive a letter written by the local council (control letter) or adjusted to reflect behavioural determinants (intervention).<br><br>3. RCT 3 Self Isolation Dronten - <br> a) IV1: Coping plans to identify potential barriers during self-isolation, two levels: participants receive an email about the coping plan (control) or discuss the coping plan over the phone (intervention). <br> b) IV2: A Stay-At-Home bag developed to address determinants of self-isolation, two levels: participants are not offered (control) or are offered the bag (intervention).<br><br>4. RCT 4 Self isolation Bunschoten - <br> a) IV1: Referral to local support services, two levels: participants are informed of the service (control) or called by the service (intervention).<br> | Test uptake: <br> a) DV1: The number of residents, per neighborhood that tested for Covid-19 during the 6-week pilot period. <br> b) DV2: The number of times a person, per neighborhood got tested for Covid-19 during the 6-week pilot period. <br><br>Self-Isolation support and adherence behaviour: <br> a) DV1: The contact times with a local support service (Bunschoten only)<br> b) DV2: The number of self-reported times a participant left their residence during the isolation or quarantine period (excluding number of times for medical reasons). <br> c) DV3: The number of self-reported times a participant received visitors during the isolation or quarantine period (excluding number of times for medical reasons).<br> | | | | No | False | | |
| → | NL8477 | 1 November 2021→15 November 2021 | BCG vaccination for healthcare workers in SARS-CoV-2 pandemic | REDUCING HEALTH CARE WORKERS ABSENTEEISM IN SARS-CoV-2 PANDEMIC BY ENHANCED TRAINED IMMUNE RESPONSES THROUGH BACILLUS CALMETTE-GUÉRIN VACCINATION, A RANDOMIZED CONTROLLED TRIAL | | University Medical Centre Utrecht | 20/03/2020 | 20200320 | Netherlands Trial Register | https://trialregister.nl/trial/8477 | Not Recruiting | No | | | | 20/03/2020 | 1500 | Interventional |
Randomized: No,
Masking: Double,
Control: Placebo,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Double, <br> Control: Placebo, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Thomas | van der Vaart | | t.w.vandervaart-2@umcutrecht.nl | 0654245404 | | Inclusion criteria: - Adult (=18 years);<br>- Male or female;<br>- Hospital personnel (expected to) taking care for patients with SARS-CoV-2 infection | Exclusion criteria: - Known allergy to (components of) the BCG vaccine or serious adverse events to prior BCG administration;<br>- Known active or latent Mycobacterium tuberculosis or with another mycobacterial species. A history with- or a suspicion of M. tuberculosis infection;<br>- Fever (>38 C) within the past 24 hours<br>- Pregnancy;<br>- Suspicion of active viral or bacterial infection;<br>- Vaccination in the past 4 weeks or expected vaccination during the study period, independent of the type of vaccination<br>- Severely immunocompromised subjects. This exclusion category comprises: a) subjects with known infection by the human immunodeficiency virus (HIV-1); b) neutropenic subjects with less than 500 neutrophils/mm3; c) subjects with solid organ transplantation; d) subjects with bone marrow transplantation; e) subjects under chemotherapy; f) subjects with primary immunodeficiency; g) severe lymphopenia with less than 400 lymphocytes/mm3; h) treatment with any anti-cytokine therapies. i) treatment with oral or intravenous steroids defined as daily doses of 10mg prednisone or equivalent for longer than 3 months, or probable use of oral or intravenous steroids in the following four weeks;<br>- Active solid or non-solid malignancy or lymphoma within the prior two years;<br>- Direct involvement in the design or the execution of the BCG-CORONA study;<br>- Expected absence from work of =4 of the following 12 weeks due to any reason (holidays, maternity leave, retirement, planned surgery etc);<br>- Employed to the hospital < 22 hours per week;<br>- Not in possession of a smartphone | SARS-CoV-2, COVID19 | Participants will be randomized between intracutaneous administration of BCG vaccine or placebo in a 1:1 ratio | Number of days of unplanned absenteeism for any reason | | | | Yes | False | | |
| → | NL8836 | 1 November 2021→15 November 2021 | Registry of COvid 19 survivors for FItness, exercise impairment and exercise Training (COFIT) | Registry of COvid 19 survivors for FItness, exercise impairment and exercise Training | | None | 14/08/2020 | 20200814 | Netherlands Trial Register | https://trialregister.nl/trial/8836 | Recruiting | No | | | | 14/08/2020 | 200 | Observational |
Randomized: No,
Masking: Single,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: Single, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Martijn | van Hooff | | m.vanhooff@mmc.nl | 0408888000 | | Inclusion criteria: Adult patients with resolved but confirmed COVID 19 infection requiring CPET as part of their rehabilitation. | Exclusion criteria: Inability to perform a cardiopulmonary exercise test. Inability to answer a questionnaire. | COVID 19 | | Cardiorespiratory fitness measured by cardiopulmonary gas exchange measurements during exercise testing | | | | Yes | False | | |
| → | NL8837 | 1 November 2021→15 November 2021 | TRACE ll Retrospective: Outcome in patients undergoing (postponed) surgery during the COVID-19 pandemic
| TRACE ll Retrospective: Outcome in patients undergoing (postponed) surgery during the COVID-19 pandemic
| | Maastricht UMC+ | 14/08/2020 | 20200814 | Netherlands Trial Register | https://trialregister.nl/trial/8837 | Recruiting | No | | | | 31/08/2020 | 14000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Carin | Wensing | | a.g.wensing@amsterdamumc.nl | 020 - 5662533 | | Inclusion criteria: - All patients who had surgery, with at least one night postoperative hospital stay<br>- Surgery in the period 15 March – 15 July 2020<br>- Patients > 18 years | Exclusion criteria: - Patients who have objected against the use of their data for scientific research as documented according to local practice | Surgery patients | None | We will retrospectively describe patient status, surgical practice and patient outcome during and directly after the peak of the COVID-19 outbreak | | | | Yes | False | | |
| → | NL8842 | 1 November 2021→15 November 2021 | Online Communities | The effectiveness of Online Communities for (expectant) mothers with stress and worries about COVID-19 | | Sasja Duijff, PhD (UU/OuderKindLijn), Eva Potharst, PhD (UvA/UvA minds) | 18/08/2020 | 20200818 | Netherlands Trial Register | https://trialregister.nl/trial/8842 | Recruiting | No | | | | 09/04/2020 | 50 | Interventional |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Eva | Potharst | | EPotharst@uvaminds.nl | 0617698305 | | Inclusion criteria: Pregnant women or women in the first month after giving birth, who speak Dutch and experience worries or stress about the COVID-19 crisis. | Exclusion criteria: Psychiatric problems for which individual or more intensive treatment is needed. | The intervention is meant for women who report anxiety and stress because of the COVID-19 crisis. | Online Communities, a 3-session online intervention offered by a psychologist and a midwife, in which participants are given information, and are taught coping strategies. | Maternal symptoms of stress, depression and anxiety | | | | No | False | | |
| → | NL8841 | 1 November 2021→15 November 2021 | TRACE ll Prospective study: Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic | TRACE ll Prospective study: Outcome in patients undergoing postponed elective surgery during the COVID-19 pandemic | | MUMC+ | 17/08/2020 | 20200817 | Netherlands Trial Register | https://trialregister.nl/trial/8841 | Not Recruiting | No | | | | 01/09/2020 | 2500 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Carin | Wensing | | a.g.wensing@amsterdamumc.nl | 020 - 5662533 | | Inclusion criteria: All adult (18 years and older) patients undergoing elective surgery, with an indication for postoperative hospital stay, and meeting at least one of the following criteria:<br>- indication of postoperative pain therapy with follow up by Acute Pain Service<br>- =60 years<br>- =45 years and a revised Cardiac Risk Index (rCRI) > 2<br>- surgical APGAR score (sAPGAR) <5 (patients not fulfilling this and any other criterion will be excluded after surgery)<br> | Exclusion criteria: - Patients who do not sign informed consent<br>- Patients who are not able to complete the questionnaires in the Dutch language<br>- Pregnancy and caesarean sectio <br> | Surgery patients | None | - 30-day incidence of major postoperative complications (including mortality) | | | | Yes | False | | |
| → | NL8705 | 1 November 2021→15 November 2021 | Quality of life in patients with suspected COVID-19 | Quality of life in patients with suspected COVID-19 | | Board of directors Ciro (Horn, The Netherlands) / Hasselt University (Hasselt, Belgium) | 04/06/2020 | 20200604 | Netherlands Trial Register | https://trialregister.nl/trial/8705 | Recruiting | No | | | | 04/06/2020 | 10000 | Observational |
Randomized: No,
Masking: Unknown,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: Unknown, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Martijn | Spruit | | martijnspruit@ciro-horn.nl | +31 (0)475 – 587 600 | | Inclusion criteria: being member from a Facebook group for corona patients with persistent complaints (The Netherlands: ‘coronaervaringen en langdurige klachten’; Belgium: 'Corona patiënten met langdurige klachten') or people who are registered at 'coronalongplein.nl' (Dutch lung foundation). | Exclusion criteria: inability to read or understand Dutch, no digital informed consent provided | COVID-19 | None | general Quality of life (5-level EQ-5D version; EQ-5D-5L) | | | | Yes | False | | |
| → | NL9378 | 1 November 2021→15 November 2021 | Identification of stressors and de-stressors in employees working from home
during COVID-19 | Identification of stressors and de-stressors in employees working from home
during COVID-19: an observational study with the use of consumer wearables | | Stichting imec Nederland | 29/03/2021 | 20210329 | Netherlands Trial Register | https://trialregister.nl/trial/9378 | Recruiting | No | | | | 24/03/2021 | 200 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Danielle | Tump | | danielle.tump@imec.nl | +31611231567 | | Inclusion criteria: - Subjects between 18 and 65 years old<br>- Subjects working for at least 4 days during the 7 days in total, from which at least 3 days are spend working from home. Each workday must consist of at least 6 hours a day<br>- Subjects are working/residing in the United States during the measurements<br>- Subjects capable of wearing a wrist-worn tracker on one of their wrists<br>- Subjects must have a smartphone newer than 2014 that runs iOs 11+ or Android 7.0+ which is continuously available to them during the whole duration of the experiment.<br>- Subjects must be capable of using a smartphone app<br>- Subjects must have English working proficiency. | Exclusion criteria: - Subjects being incapable (for whatever reason) to properly read/understand/sign the informed consent and subject information.<br>- Subjects with known atherosclerosis and/or cardiovascular impairments.<br>- Subjects with a known medical condition that will increase risk of infections due to the electrodes like for example wounds on hand and arm or skin allergies.<br>- Subjects with a known allergy to silicone.<br>- Subjects wearing any other measuring device which cannot be removed (i.e. Holter monitor).<br>- Patients with known sensitivity to light or using medication with phototoxic side ef-fects (i.e. Tetracycline, Doxycycline, Phenothiazines, Dacarbazine, Ketoprofen, Lomefloxacin). This is in order to exclude the possibility of local skin irritation from prolonged irradiation by LED-light (from the wearable on the wrist).<br>- Women known to be pregnant.<br>- Subjects with any implanted active device (i.e.,. device containing a battery), such as a pacemaker.<br>- Subjects with epilepsy or known sensitivity to bright light<br>- Subjects with known nervous system disorders.<br>- Subjects with known mental disorders<br>- Subjects in therapy or taking medication for psychiatric disorders | None | Daily questionnaires and continuously wearing a consumer wrist-worn sensor | Determine stressors and de-stressors in employees working from home | | | | No | False | | |
| → | NL9379 | 1 November 2021→15 November 2021 | A Phase I-II study of virus neutralizing antibodies against SARS-CoV-2. A focus on convalescent plasma and hyperimmune anti-SARS-CoV2 immunoglobulines | A Phase I-II study of virus neutralizing antibodies against SARS-CoV-2. A focus on convalescent plasma and hyperimmune anti-SARS-CoV2 immunoglobulines | | Erasmus MC | 29/03/2021 | 20210329 | Netherlands Trial Register | https://trialregister.nl/trial/9379 | Recruiting | No | | | | 01/04/2021 | 104 | Interventional |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Bart | Rijnders | | b.rijnders@erasmusmc.nl | +31650033572 | | Inclusion criteria: - 18 years or older<br>- Informed consent<br>- B-cell depleted status because one of following:<br> * Prior B-cell depletion therapy (latest administration < 6 months prior to<br> inclusion)<br> * Common variable immunodeficiency requiring IVIG suppletion | Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from<br>participation in this study:<br>? Symptoms of respiratory infection at time of inclusion<br>? Anti-SARS-CoV2 antibodies prior to administration of study product<br>? Positive SARS-CoV-2 PCR<br>? Known previous history of transfusion-related acute lung injury<br>? Known IgA deficiency<br>? Liver cirrhosis<br>? Known hypersensitivity to human immunoglobulins<br>? Received anti-SARS-CoV-2 vaccination in the 4 weeks preceding screening or<br>baseline | COVID-19 | Infusion of convalescent plasma or Nanogam plus (IVIG-therapy containing anti-SARS-CoV-2 antibodies) | ? Pharmacokinetics of virus neutralizing antibodies of ConvP<br>? Pharmacokinetics of virus neutralizing antibodies of Nanogam®plus | | | | Yes | False | | |
| → | NL8882 | 1 November 2021→15 November 2021 | The psychological well-being and health-related quality of life of patients admitted to the hospital with COVID-19. | The psychological well-being and health-related quality of life of patients admitted to the hospital with COVID-19. | | Franciscus Gasthuis & Vlietland Group | 07/09/2020 | 20200907 | Netherlands Trial Register | https://trialregister.nl/trial/8882 | Not Recruiting | No | | | | 28/05/2020 | 250 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Johan | Vlake | | j.vlake@erasmusmc.nl | +31641545743 | | Inclusion criteria: - Above 18 years of age<br>- Admitted with symptoms suitable with COVID-19 (respiratory (dyspnea, coughing, sore throat, rhinorhea, saturation <94%, respiratory rate >24/minute) or gastro-intestinal (diarrhea, vomiting) for a duration >24 hours) and eventually tested for SARS-CoV-2 using PCR.<br>- Able to understand the Dutch language | Exclusion criteria: - Patients who participate in interventional trials of which the outcomes interfere with the outcomes in the current study<br>- Patients without a formal home adress and without an e-mail address. | COVID-19 | | The occurrence and severity of psychological distress, defined as either one or a combination of PTSD, depression and/or anxiety, at 1, 3 and 12 months after hospital discharge in patients admitted with symptoms suitable with COVID-19 during the COVID-19 pandemic. | | | | No | False | | |
| → | NL8903 | 1 November 2021→15 November 2021 | A diet for the treatment of gout | A pilot randomized controlled trial with a one-year extension period on the effect of a whole food plant-based diet for patients with gout | | Reade | 15/09/2020 | 20200915 | Netherlands Trial Register | https://trialregister.nl/trial/8903 | Recruiting | No | | | | 15/09/2020 | 30 | Interventional |
Randomized: No,
Masking: Single,
Control: Active,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: Single, <br> Control: Active, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Wendy | Walrabenstein | | w.walrabenstein@reade.nl | +31658869219 | | Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:<br>• Diagnosis of gout confirmed by a rheumatologist (first or recurrent episode) based on the ACR criteria.<br>• Hyperuricemia (? = 7 mg/dL (0.42 mmol/L) and ? = 6 mg/dL (0.36 mmol/L)) (2).<br>• Waist circumference of ? = 102 cm and ? = 88 cm. | Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:<br><br>• Concurrent presence of other forms of inflammatory joint disease than gout. <br>• Intractable gout due to side effects or contra-indications for standard flare treatment (NSAIDs, colchicine and corticosteroids).<br>• Current use of urate lowering therapy or use of urate lowering therapy in the last 30 days. <br>• Indication for urate lowering therapy according national guidelines (NVR guideline gout 2013: https://www.nvr.nl/richtlijnen/nvr-richtlijnen-standpunten-en-zorgpaden/) including ?2 flares in one year, tophaceous gout or history of urate urolithiasis. Unless agreement between patient and treating rheumatologist led to the decision to postpone the start of ULT for the duration of at least the first 4 months of the study.<br>• Pregnancy.<br>• Insufficient comprehension of Dutch language.<br>• Already following a (near-)vegan diet.<br>• In case of smoking, unwillingness to stop smoking for at least the duration of the study.<br>• Low e-health competencies (lowest proficiency according to Pharos quick scan, see appendix B). <br>• Inability to be scheduled for counselling and measurement visits.<br>• Psychiatric disease. <br>• No informed consent. | Gout | The dietary intervention is a whole food plant based diet and it will be offered as an individual counselling package of in total 3 hours divided between introduction session (60 minutes) and four consecutive sessions of 30 minutes at 2, 4, 8 and 12 weeks. All counselling sessions will take place at Reade. The follow-up sessions can also take place online via video-call if physical face-to-face contact will not be possible due to the external circumstances (e.g. COVID-19 precaution measures). | Serum uric acid | | | | Yes | False | | |
| → | NL8706 | 1 November 2021→15 November 2021 | Extracorporeal membrane oxygenation in patients with coronavirus disease 2019 | Extracorporeal membrane oxygenation in patients with coronavirus disease 2019; a retrospective observational international multi-center study | | N/A | 09/06/2020 | 20200609 | Netherlands Trial Register | https://trialregister.nl/trial/8706 | Recruiting | No | | | | 01/06/2020 | 200 | Observational |
Randomized: No,
Masking: None,
Control: Unknown,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Unknown, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Alexander | Vlaar | | a.p.vlaar@amsterdamumc.nl | +31205669111 | | Inclusion criteria: - Patients had to require ECMO during their hospital admission at the ICU.<br>- Patients had to be =18 years old.<br>- The ICU admission took place between March 1st 2020 up to December 31st<br> 2020.<br> | Exclusion criteria: Patients without COVID-19 on ECMO | PCR-proven COVID-19, resulting in respiratory or cardiorespiratory insufficiency, refractory to conventional therapies. | None | To quantify patient and ECLS characteristics of patients on ECLS due to COVID-19. | | | | No | False | | |
| → | NL8922 | 1 November 2021→15 November 2021 | COntinuation Versus Interruption of Immunomodulating Drugs in case of an Infectious disease in IMID patients (COVID I2 study), with special attention for COVID 19: a pragmatic, explorative randomized controlled trial | COntinuation Versus Interruption of Immunomodulating Drugs in case of an Infectious disease in IMID patients (COVID I2 study), with special attention for COVID 19: a pragmatic, explorative randomized controlled trial | | Sint Maartenskliniek | 23/09/2020 | 20200923 | Netherlands Trial Register | https://trialregister.nl/trial/8922 | Not Recruiting | No | | | | 01/10/2020 | 2200 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Merel | Opdam | | m.opdam@maartenskliniek.nl | 0640502845 | | Inclusion criteria: - Clinical diagnosis of at least one of the following IMIDs: Rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (axSpA), psoriasis (PsO) or inflammatory bowel disease (IBD) (i.e. Crohns disease (CD) or ulcerative colitis (UC). <br>- Age = 16 years<br>- Using one or more of the following immunomodulating agents (IA) from table 1 in any dose. Monotherapy rituximab and glucocorticoids are exempts because rituximab cannot be stopped due to long half-life time and post pharmacokinetic effects on b-cell depletion, and glucocorticoids because stopping is associated with secondary hypocortisolism.<br>- Not experiencing any clinical infection at time of inclusion (based on check in electronic health record and as reported by patient at inclusion). <br>- Ability to read and communicate well in Dutch | Exclusion criteria: - Use of the following immunomodulating agents in monotherapy and through intravenous administration: rituximab, tocilizumab or abatacept. This because the contrast between stopping and continuation is expected to be low, as the treatment intervals are high, and intravenous medication is not easily provided in case of hospital admission.<br>- Use of glucocorticoids (GC) in monotherapy, because stopping of GC is not feasible due to risk of GC use induced hypocortisolism<br>- Not willing to be randomized to either intervention or control condition. <br>- Not being able to be followed for 12 months, because of planned relocation or short life expectancy.<br> | Rheumatoid arthritis
Psoriatic arthritis
Axial spondyloarthritis
Psoriasis
Ulcerative colitis
Crohn disease | The intervention consists of continued IA treatment and the control condition is interruption of IA treatment until the infection is resolved, all in addition to standard of care. | Proportion of participants with a serious infection, i.e. grade 3 or higher (according to the Common Toxicity Criteria for Adverse Events (CTCAE) version 5.0). | | | | Yes | False | | |
| → | NL8926 | 1 November 2021→15 November 2021 | Clinical features of COVID-19 in Pediatric Patients, long term effects
| Clinical features of COVID-19 in Pediatric Patients, long term effects | | Amsterdam UMC, location AMC | 11/09/2020 | 20200911 | Netherlands Trial Register | https://trialregister.nl/trial/8926 | Not Recruiting | No | | | | 01/10/2020 | 120 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Caroline | Kosterink-Brackel | | c.l.brackel@amsterdamumc.nl | +31 20 5669111 | | Inclusion criteria: - Aged 0-17 years at COVID-19 diagnosis, AND<br>- Presented to an emergency or outpatient department of a Dutch hospital and/or admitted to hospital, AND<br>- Diagnosed with COVID-19 in his/her medical history, based on at least one positive real-time RT-PCR test on nasopharyngeal, oropharyngeal, sputum or fecal sample for SARS-CoV-2 OR fulfilled a clinical diagnosis of COVID-19, should testing of SARS-CoV-2 yield inconclusive results and/or if testing is no longer possible due to lack of reagents, AND<br>- Enrolled in the COPP study (Clinical features of COVID-19 in Pediatric Patients (23)), with specific consent to be approached for follow-up studies. | Exclusion criteria: - Consent from guardians and/or patient is not received, or <br>- Consent for COPP study data access is not received | Covid-19 in children | | - To describe potential pulmonary sequelae, in particular symptoms, the need for hospital care, at 6 to 12-months following a COVID-19 diagnosis among pediatric patients receiving care in the hospital or outpatient setting in the Netherlands.<br>- To determine risk factors for pulmonary sequelae among COVID-19 hospitalized and outpatient pediatric patients in the Netherlands.<br> | | | | Yes | False | | |
| → | NL9590 | 1 November 2021→15 November 2021 | Longevity of specific and cross-reactive cellular responses to coronaviruses in comparison to serology in COVID-19 convalescent individuals | Longevity of specific and cross-reactive cellular responses to coronaviruses in comparison to serology in COVID-19 convalescent individuals | | Department of Viroscience, Erasmus MC; Innatoss Laboratories B.V.; TKI Life Sciences & Health, Health~Holland | 09/07/2021 | 20210709 | Netherlands Trial Register | https://trialregister.nl/trial/9590 | Not Recruiting | No | | | | 01/06/2021 | 100 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Rory | de Vries | | r.d.devries@erasmusmc.nl | +31642127910 | | Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria:<br><br>• Aged at least 18 years old<br>• Self-reported clinical history consistent with COVID-19<br>• Laboratory-confirmed history of SARS-CoV-2 infection (seroconversion)<br> | Exclusion criteria: There are no specific criteria for subjects to be excluded from participation in this study, as long as they adhere to the inclusion criteria mentioned above. | COVID-19 | | To test the hypothesis that T-cell responses are more long-lived than antibody responses, we will compare the proportion of COVID-19 convalescent individuals with detectable T-cell and antibody responses to different SARS-CoV-2 proteins. The responses will be treated as a categorical variable (positive or negative). Cut-offs for positivity of T-cell responses to the various antigens will be established based on pre-pandemic samples in a different part of the overarching CoviCross project.<br><br>We will perform a multivariate analysis of variance (MANOVA). MANOVA compares groups on a set of dependent variables simultaneously. Rather than test group differences using several separate ANOVAs and run the risk of increased familywise error (probability of one or more Type I errors), the MANOVA approach makes a single comparison and the analysis therefore does not have to be adjusted for multiple hypothesis testing.<br> | | | | No | False | | |
| → | NL9419 | 1 November 2021→15 November 2021 | Precision Medicine for more Oxygen - COVID-19 extension | Precision Medicine for more Oxygen - COVID-19 extension | | Amsterdam UMC, location AMC | 19/04/2021 | 20210419 | Netherlands Trial Register | https://trialregister.nl/trial/9419 | Recruiting | No | | | | 19/04/2021 | 100 | Interventional |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Job | van Bragt | | j.j.vanbragt@amsterdamumc.nl | 0205661660 | | Inclusion criteria: - Age: 40-65 years.<br>- Proven ex-COVID-19: Positive PCR/serology for SARS-CoV2 or CORADS score 4/5. <br>- Able to provide informed consent.<br>- Access to internet (either at home or via relatives/friends).<br>- Understanding of Dutch language.<br> | Exclusion criteria: - Inability to provide informed consent.<br>- History or suspicion of inability to cooperate adequately.<br>- Participation in any other study involving investigational or marketed products concomitantly or within four weeks prior to entry into the study or during the study.<br>- Investigator’s uncertainty about the willingness or ability of the patient to comply with the protocol requirements.<br>- Patients with terminal illness.<br> | COVID-19 | The efficacy of a personalized counselling intervention will be investigated in a nested study. Half of the patients will receive a personalized counselling intervention based on dietary quality and physical activity, which will consist of individual, group and educational sessions. Furthermore, this group will voluntary be provided with additional tailored nutritional support. The other half of the group will serve as control group and will not receive personalized counselling or nutritional support. However, this group might participate in the educational sessions (voluntary). | A. To assess pulmonary and extra-pulmonary damage (with imaging techniques), complaints (e.g. fatigue and Quality of Life) and other signs of disease (both clinical signs and multi-omics biomarkers) in the year after infection in ex-COVID-19 patients.<br>B. To assess whether a personalized counselling intervention on quality of dietary intake and level of physical activity can improve general health and decrease complaints and signs of disease (both pulmonary and extrapulmonary). | | | | Yes | False | | |
| → | NL8993 | 1 November 2021→15 November 2021 | Online cognitive behavioral therapy for distress in people who lost a loved one during the corona pandemic: A randomized waitlist-controlled trial | The effectiveness of an online cognitive behavioral therapy for distress in people who lost a loved one during the corona pandemic: A randomized waitlist-controlled trial | | Utrecht University | 21/10/2020 | 20201021 | Netherlands Trial Register | https://trialregister.nl/trial/8993 | Recruiting | No | | | | 01/07/2020 | 52 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Lyanne | Reitsma | | l.reitsma@uu.nl | 06-22299573 | | Inclusion criteria: In order to be eligible to participate in this study, a person must be a family member, spouse or friend of a person who died (whether or not due to the coronavirus) during the COVID-19 pandemic (period March 2020 till current); - the death occurred at least three months earlier; - = 18 years of age; - report clinically relevant symptom-levels of PCBD, PTSD and/or MDD based on telephone interviews. | Exclusion criteria: Participants will be excluded when they do not have access to the internet, do not master the Dutch language and/ or suffer from a psychotic disorder or are suicidal. | Persistent Complex Bereavement Disorder, Post Traumatic Stress Disorder, Major Depressive Disorder | The online grief-specific unguided CBT is targeted at people with clinically relevant levels of distress (PCBD, PTSD and/or MDD) at least three months after the loss of a loved one. It could therefore be considered a secondary preventive intervention and not a primary preventive intervention (that includes self-help modules available to all bereaved people; Schut & Stroebe, 2005). The online CBT consists of eight weekly sessions that are tailored to this specific population. Following the Dutch guidelines for grief-specific CBT, central components of the current online treatment are exposure, cognitive restructuring and behavioral activation (Boelen & van den Bout, 2017). In the first session, psychoeducation is given about possible emotional reactions to the death of a loved one during the pandemic and processes that might foster or block recovery. Psychoeducation is tailored to the population, by providing information about (factors of) distress that are particularly relevant for this population, such as the impact of the absence of traditional grief rituals, lack of physical social support, and fear for contamination with COVID-19. A rationale for the CBT interventions is provided. Then, several sessions are spent on exposure; the story of the loss (and its circumstances) is discussed in detail and the participant is helped to confront stimuli that s/he tends to avoid. The rationale of exposure is described by given examples of avoidance of stimuli that are relevant for this population (e.g., avoidance of the location of the hospital where the loved one died). The next sessions focus on identifying and changing negative cognitions that block adjustment; specific attention is paid to cognitions connected with responsibility/ guilt and fear, that may be elevated follow | PCBD symptoms will be assessed with the Traumatic Grief Inventory – Clinician-Administered (Lenferink et al., in prep.). | | | | No | False | | |
| → | NTR441 | 1 November 2021→15 November 2021 | Patient satisfaction in the treatment of anal fissure. | Prospective randomised multicentre trial of satisfaction of treatment of anal fissure with isosorbide dinitrate or botuline toxin A injections. | | Ipsen Farmatherapeutica bv
Hoofdweg Oostzijde 620
2132 MJ Hoofddorp nederland
tel: 023-5541600
fax: 0235541609
www.IPSEN.NL@IPSEN.com
www.ipsen.com | 09/09/2005 | 20050909 | Netherlands Trial Register | https://trialregister.nl/trial/402 | Not Recruiting | Yes | | | | 08/11/2004 | 50 | Interventional |
Randomized: No,
Masking: Single,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Single, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | W.F. | Tets | | w.vantets@slaz.nl | | | Inclusion criteria: 1. Diagnosed anal fissura with complaints;
<br>2. Complaints longer than 2 months;
<br>3. Age 21-60 year;
<br>4. Speaking dutch;
<br>5. Will-competent;
<br>6. Informed consent. | Exclusion criteria: 1. Pregnancy, lactation;
<br>2. Muscle-sicknesses such as myasthenia gravis;
<br>3. Simultaneous use of medication interacting with neuromusculair transmission;
<br>4. Fistulas;
<br>5. Coagulation disorders or th use of anticoagulantia;
<br>6. Anal surgery in the past;
<br>7. Haemorrhoiden or inflammatory bowel sicknesses as a cause of anal fissure;
<br>8. Major secundaire changes because of the anal fissure. | | ISDN1% Creme versus Botuline Toxine A<br>Duration 12 weeks.<br>ISDN creme application every 4 ours for 12 weeks.<br>Or Botuline Toxine A injection at week 0 and if neccesary at week 6 again<br>Botuline Toxine A Dysport fabrikant Ipsen. | 1. Patient satisfaction after 6 weeks;<br>2. Visual Analoge Score on week 0,6 and 12. | | | | No | True | parent | |
| → | NL9007 | 1 November 2021→15 November 2021 | Exercise via videoconferencing for people with severe mental illness during covid-19 times, a feasibility study | Exercise via videoconferencing for people with severe mental illness during covid-19 times, a feasibility study | | W. Cahn | 29/10/2020 | 20201029 | Netherlands Trial Register | https://trialregister.nl/trial/9007 | Recruiting | No | | | | 09/06/2020 | 70 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Lisanne | Koomen | | l.e.m.koomen-2@umcutrecht.nl | 0625777160 | | Inclusion criteria: severe mental illness, possessing a device with webcam and Internet connection and age between 16-70. | Exclusion criteria: Unable to perform physical exercise. | severe mental illness | Twice weekly group exercise (pilates and/or fitness) via live videoconferencing for a duration of 12 weeks. | Feasibility as measured with a questionnaire based on the MIDI and attendance rate. | | | | No | False | | |
| → | NL9019 | 1 November 2021→15 November 2021 | Effect of Iodine treatment in patiënts with COVID-19 disease | Effect of Iodine treatment in patiënts with COVID-19 disease | | Maxima Medisch Centrum | 23/10/2020 | 20201023 | Netherlands Trial Register | https://trialregister.nl/trial/9019 | Not Recruiting | No | | | | 23/10/2020 | 200 | Interventional |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Rene | Traksel | | r.traksel@mmc.nl | 040-8885676 | | Inclusion criteria: Patients 18 years of age and older, admitted to a hospital and who are tested positive for SARS-CoV-2 infection, are recruited for the study. <br>Patiënts must be legally competent and able to read the patient's information letter and sign the informed consent form. | Exclusion criteria: Thyroid disease or treatment, like goiter, thyroidectomy, radioactive iodine, medication related to thyroid dysfunction or the use of Amiodaron. | COVID 19 | Once daily a quarter of a 65 mg potassiumiodine tablet during eight consecutive days | 1. Number of necessities to transfer from regular ward to IC department<br>2. Mortality rate | | | | Yes | False | | |
| → | NL9018 | 1 November 2021→15 November 2021 | Performance evaluation of a sars-cov-2 rapid antigentest: test performance in the community in the netherlands | Performance evaluation of a sars-cov-2 rapid antigentest: test performance in the community in the netherlands | | Amphia Hospital Breda | 19/10/2020 | 20201019 | Netherlands Trial Register | https://trialregister.nl/trial/9018 | Recruiting | No | | | | 26/09/2020 | 1000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Nathalie | Van der Moeren | | n.vdmoeren@gmail.com | 0032470888849 | | Inclusion criteria: In order to evaluate clinical specificity, symptomatic adults (=18 years) who present at a participating GGD test centre for a COVID- 19 test will be included. In order to evaluate clinical sensitivity, symptomatic adults (=18 years) who were tested positive with qRT-PCR in a participating GGD test centre will be included. | Exclusion criteria: Age <18 years | COVID-19 | | For part one of the study the primary outcome was the VRD clinical sensitivity and specificity compared to qRT-PCR. For the second part of the study the primary outcome was VRD clinical sensitivity compared to qRT-PCR stratified by Ct-value category (Ct<20, Ct20-25, Ct25-30 and Ct=30) and time since symptom onset (< 7 days, = 7 days). | | | | No | False | | |
| → | NL8947 | 1 November 2021→15 November 2021 | ReCOVer: Cognitive Behavioural Therapy for post-COVID-19 fatigue | ReCOVer: A Randomised Controlled Trial testing the efficacy of Cognitive Behavioural Therapy for preventing chronic post-infectious fatigue among patients diagnosed with COVID-19. | | Amsterdam University Medical Centers | 04/10/2020 | 20201004 | Netherlands Trial Register | https://trialregister.nl/trial/8947 | Recruiting | No | | | | 05/10/2020 | 114 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Tanja | Kuut | | moeCOVID@amsterdamumc.nl | 020-4443925 | | Inclusion criteria: - The patient was diagnosed with symptomatic COVID-19, confirmed by a positive PCR for SARS-CoV-2, another positive NAAT test (RT-PCR, LAMP, TMA or mPOCT), positive SARS-CoV-2 serology, a positive Antigen test or CORADS 4 or 5 on CT-scan; <br>- The patient is 3 up to and including 12 months after being diagnosed with COVID-19 or after hospital discharge in case the patient was admitted;<br>- The patient experiences severe levels of fatigue (= 35 on the fatigue subscale of the Checklist Individual Strength [CIS-fatigue]). The severe fatigue started with or increased substantially directly after the onset of symptoms of COVID-19;<br>- The patient reports physical disability (= 65 on the Rand36 physical functioning subscale) and/or social disability (= 10 on the Work and Social Adjustment Scale [WSAS]);<br>- The patient is 18 years of age or older;<br>- The patient has sufficient command of the Dutch language.<br> | Exclusion criteria: - The patient has an already known psychiatric or somatic condition that can explain his/her fatigue. We will also screen for the presence of Post-Traumatic Stress Disorder ([PTSD], (PCL-5) which prevalence may be high in this patient group because of traumatic experiences during the acute phase of COVID-19. We will also screen for the presence of depressive disorder (Mini- International Neuropsychiatric Interview); <br>- The patient currently participates in a multi-disciplinary rehabilitation programme aimed to ameliorate the consequences of COVID-19;<br>- The patient has objectified hypoxemia in rest for which oxygen therapy at home is indicated.<br> | COVID-19; fatigue | Patients will be randomised to either iCBT or care as usual (ratio 1:1).<br>iCBT<br>The intervention to be delivered is internet-based Cognitive Behavioural Therapy [iCBT]. This intervention is based on the cognitive-behavioural model of fatigue, stating that disease and/or its treatment initially triggers fatigue while cognitive-behavioural variables perpetuate fatigue. <br>Patients randomised to iCBT will receive 4 months (17 weeks) of individual iCBT, based on an existing treatment manual for chronic fatigue which has been adapted to COVID-19. iCBT will be delivered by trained cognitive-behavioural therapists on a secured webportal and entails up to 9 modules. Of these modules, 7 target the perpetuating factors of fatigue. Patients only receive modules that are indicated for them, based on baseline scores (T0) and intake. Patients who are not able or willing to follow iCBT will be offered face-to-face CBT at a treatment facility or via video consults using the same treatment manual. <br><br>Care as usual<br>Currently, care as usual for patients who passed the acute phase of COVID-19 can entail different forms of care. Participants will have no access to the study intervention during the study period, but are not restrained from using any care for their fatigue or a related symptoms/health complaints (e.g. through referral by their practitioner). | Mean fatigue severity score (CIS-fatigue) across follow-up visits (T1 and T2) | | | | Yes | False | | |
| → | NL9430 | 1 November 2021→15 November 2021 | Intranasal LMWH against COVID-19 | Intranasal LMWH against COVID-19 | | ZonMW | 04/02/2021 | 20210204 | Netherlands Trial Register | https://trialregister.nl/trial/9430 | Recruiting | No | | | | 20/01/2021 | 24 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Killian | Vlaming | | k.e.vlaming@amsterdamumc.nl | 0657288085 | | Inclusion criteria: In order to be eligible for participation, a participant must: <br>- be able to provide written informed consent (Verbal informed consent or deferred informed concent will be used for the initial screening visit, where written informed consent will be obtained).<br>- be physically healthy (as defined by not suffering from any illness or disease obstructing general daily functioning)<br>- be aged between 18 – 65 years<br>- be sufficiently well versed in the Dutch language, subject to the opinion of the Investigator<br><br>For our control cohort, a participant who wishes to partake must be admitted to the AMC Amsterdam and be given therapeutic doses of LMWHs for an underlying thrombotic illness without any side diagnoses. (Participants must use therapeutic doses of any LMWH (e.g. nadroparin 5,700 U BID / 11,400 U OD or higher; enoxaparin 6,000 U BID / 9,000 U OD or higher. Tinzaparin 10,500 Units or higher)) | Exclusion criteria: If any of the following apply to someone wishing to participate, he/she is rendered ineligible for participation, a participant:<br>- is unlikely to comply with study procedures, as deemed by the recruiting research doctor/nurse<br>- has mental disorders that in the view of the investigator would interfere with adherence to study procedures or might impair a decision to participate in the study<br>- has a known allergy or intolerance to LWWH or heparine-related products, as well as a medical history of heparine inducted thrombocytopenia (HIT).<br>- has any relevant clinical medical condition that is in the opinion of the investigator to make a volunteer unsuitable for participation in the study (under which underlying haematological disorders or bleeding disorder.<br>- has (anamnestic) evidence of a respiratory infection in the 4 weeks prior to enrolment. <br>- has a tympanic temperature exceeding 38,5 degrees Celsius during the screening and clinical visits.<br>- has frequent nosebleeds (>1/ month). | COVID-19 | In cohort 1: <br>Intervention medication: 4500IE enoxaparin (in 300uL water)<br>Control medication: NaCl 0,9% (in 300uL water)<br><br>In cohort 2:<br>Nothing, medication has been given as therapeutic intervention for an underlying thrombotic event. | pseudotyped SARS-CoV-2 binding to cells acquired from the volunteers right (enoxaparin) and left (NaCl) nostrils (in cohort 1), or left nostril (in cohort 2)<br><br>At 30minutes after administering trial medication cells will be removed using a nasal swab from respectively the right and left nostril. These cells will be exposed to our pseudotyped SARS-CoV-2 virus. This is a single-round modified corona-virus with an HIV-backbone. The virus will be exposed to the acquired cells for four hours after which the cells will be lysed and virus-binding will be measured using a p24 ELISA. (Elisa kit made by Zeptometrix)<br>This protein is unique to HIV, presence of the protein within the sample will indicate viral binding and internalisation. This can only happen after succesful binding to ACE-2 and Syndecan receptors. Blocking the syndecan receptor will prevent this.<br><br>Timepoints: Virusbinding happens on the same day as cells are obtained from study participants to ensure maximum viability of cells, virus exposure happens for 4 hours at 4C after which all cells are lysed to prevent further infection. | | | | No | False | | |
| → | NL9436 | 1 November 2021→15 November 2021 | COVID-Compromise | Convalescent Antibody-Mediated Treatment of COVID-19 Infections in Patients with B-cell dysfunction, a Randomized Trial COVID-Compromise Study | | AmsterdamUMC | 22/04/2021 | 20210422 | Netherlands Trial Register | https://trialregister.nl/trial/9436 | Recruiting | No | | | | 15/04/2021 | 86 | Interventional |
Randomized: No,
Masking: Double,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Double, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Jarom | Heijmans | | j.heijmans@amsterdamumc.nl | 628238996 | | Inclusion criteria: ? Patient is = 18 years of age, diagnosed with COVID-19 based on a positive PCR or antigen<br>test.<br>? Hospitalized.<br>AND one of immunocompromised conditions/treatments below<br>B-cell inhibition related ICP<br>? Use of anti-CD19 or -CD20 directed antibody therapy in 6 months prior to inclusion.<br>? Previous or current treatment with drugs that significantly impair B cell function (e.g. ibrutinib,<br>venetoclax, acalabrutinib, idelalisib etc) within 6 months prior to inclusion<br>Other immunosuppression/treatment related ICP<br>? Patients treated with bendamustine, purine analogues or anti-thymocyte globulin within 6<br>months prior to inclusion.<br>? Solid organ transplant patients that are taking systemic immunosuppressive drugs from at<br>least three pharmacological classes.<br>Cellular therapy related ICP<br>? Allogeneic hematopoietic stem cell transplant (HSCT) in 12 months prior to inclusion.<br>? HSCT for which systemic therapy against graft-versus-host-disease is used.<br>? Recipient of CAR-T cells < 2 years prior to inclusion.<br>Disease related ICP<br>? Chronic B-cell leukemia´s: CLL, HCL, PLL, multiple myeloma, Waldenströms<br>macroglobulinemia<br>Congenital ICP<br>? Congenital disorder resulting in severe B-cell dysfunction or depletion requiring<br>immunoglobulin suppletion (e.g. agammaglobulinemia). | Exclusion criteria: ? Has previously participated in this study.<br>? Has previously received convalescent plasma with high level neutralizing anti-SARS-CoV-2<br>antibodies (either in other study or in compassionate use program).<br>? Known hypersensitivity to treatment with immunoglobulins (WHO grade 3-4).<br>? Patient who has reached endpoint already at admission (direct adjunctive oxygen therapy in<br>the form of high-flow nasal oxygen (HFNO), mechanical ventilation or ICU admission for other<br>reason). | COVID-19 | treatment with Nanogam (purified immunoglobulin concentrate) with or without high dose neutralizing anti COVID-19 antibodies | more severe course of COVID-19 | | | | No | False | | |
| → | NL8954 | 1 November 2021→15 November 2021 | A randomised controlled pilot trial investigating the feasibility of monitoring patients with or at risk for cardiovascular disease who have symptoms suspected of COVID-19 by pulse oximetry at home | A randomised controlled pilot trial investigating the feasibility of monitoring patients with or at risk for cardiovascular disease who have symptoms suspected of COVID-19 by pulse oximetry at home | | UMC Utrecht | 06/10/2020 | 20201006 | Netherlands Trial Register | https://trialregister.nl/trial/8954 | Recruiting | No | | | | 01/11/2020 | 50 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Dorien | Zwart | | d.zwart@umcutrecht.nl | 088 75 681 81 | | Inclusion criteria: 1) Age =40 years<br>2) Cardiovasculair risk profile or cardiovascular disease (overweight, hypertension, diabetes, smoking, coronary artery disease, previous myocardial infarction, heart failure)<br>3) Presumably COVID-19 (both SARS-CoV-2 positive and non-COVID-19 confirmed patients)<br>4) Moderate-severe symptoms<br>5) Mentally competent | Exclusion criteria: 1) Severe illness requiring hospital admission<br>2) Patient does not want future hospitalisation<br>3) Known anemia<br>4) Inadequate mastery of the Dutch language <br>5) Not willing to sign informed consent<br>6) Not willing to adhere to study procedures | Patients presenting to primary care with moderate to severe symptoms of COVID-19 (both SARS-CoV-2 positive and untested patients). | Three times daily (and if needed any additional) measurement of oxygen saturation and pulse rate with a pulse oximeter as added to usual (primary) care versus usual (primary) care. | Feasibility defined as successful inclusion of 50 participants within 6 months | | | | Yes | False | | |
| → | NL9063 | 1 November 2021→15 November 2021 | COVID-19 pandemic impact on severe asthma patients care in Europe | COVID-19 pandemic impact on severe asthma patients care in Europe | | SHARP | 18/11/2020 | 20201118 | Netherlands Trial Register | https://trialregister.nl/trial/9063 | Not Recruiting | No | | | | 22/11/2020 | 900 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Katrien | Eger | | k.a.eger@amsterdamumc.nl | 0205667924 | | Inclusion criteria: patients with physician diagnosed severe asthma who are followed up in an asthma clinic for at least 6 months at the beginning of the COVID-19 pandemic | Exclusion criteria: none | Severe asthma | Online or paper version survey | Description of changes in severe asthma care. | | | | Yes | False | | |
| → | NL9093 | 1 November 2021→15 November 2021 | Pulmonary and fitness characteristics of COVID-19 patients with persistent dyspnea and / or reduced exercise capacity | Pulmonary and fitness characteristics of COVID-19 patients with persistent dyspnea and / or reduced exercise capacity | | not applicable | 04/12/2020 | 20201204 | Netherlands Trial Register | https://trialregister.nl/trial/9093 | Recruiting | No | | | | 01/06/2020 | 100 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Tom | Wiggers | | t.g.h.wiggers@olvg.nl | 020-5108710 | | Inclusion criteria: 1. Suffered from COVID-19 based on clinical criteria (fever, dyspnea, coughing, loss of smell and/or loss of taste) in March 2020 or later and currently have symptoms of dyspnea (in rest and/or during exercise) and/or reduced exercise capacity.<br>2. Age: 16 years or older.<br>3. Normally doing sports at least once a week.<br>4. Is able to perform a CPET. | Exclusion criteria: Another diagnosis is regarded as the cause of the symptoms. | COVID-19 | none | Exploratory research into possible variables in CPET and pulmonary function tests that are abnormal after suffering from COVID-19. Therefore it is not possible to define 1 primary outcome measure. | | | | No | False | | |
| → | NL8309 | 1 November 2021→15 November 2021 | Impact of COVID-19 on physical activity and lifestyle of school going adolescents of Punjab (ICPASA): Designing an evidence-based physical activity intervention in COVID era | Impact of COVID-19 on physical activity and lifestyle of school going adolescents of Punjab (ICPASA): Designing an evidence-based physical activity intervention in COVID era | | None | 13/01/2020 | 20200113 | Netherlands Trial Register | https://trialregister.nl/trial/8309 | Not Recruiting | No | | | | 25/09/2018 | 834 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Supriya | Thapar | | supriya.thapar@maastrichtuniversity.nl | +919988011770 | | Inclusion criteria: 1. Adolescents in the age group of 10-19 years.<br>2. Adolescents enrolled in urban schools of SAS Nagar. | Exclusion criteria: Children who have physical deformity, are mentally retarded, or have acute/prolonged fever. | Prevention of non communicable diseases | Natural experiment of coronavirus related governmental measures | Change in proportion of adolescents performing sufficient physical activity as per WHO guidelines after school closures due to COVID-19. The change in physical activity levels will be calculated using self-report measures through questionnaire and objective measures using ActiGraph on a sub-sample. | | | | No | False | | |
| → | NL9629 | 1 November 2021→15 November 2021 | COVID-19 selftest distribution at food banks | COVID-19 selftest distribution at food banks | | Dutch Ministry of Health, Welfare and Sport | 20/07/2021 | 20210720 | Netherlands Trial Register | https://trialregister.nl/trial/9629 | Recruiting | No | | | | 08/07/2021 | 100 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Leonie | Venhoeven | | leonie@dbgedrag.nl | 06 341 57 593 | | Inclusion criteria: All customers visiting the participating Dutch food banks on the day of the data collection were invited to partake in the study. | Exclusion criteria: No exclusion applied to participation. | Covid-19 | N/A | The extent to which following COVID-19 guidelines (e.g. social distancing, PCR testing when experiencing health issues) changes after administering a self-test. | | | | No | False | | |
| → | NL9082 | 1 November 2021→15 November 2021 | Serum Amyloid A as a prognostic marker for disease severity and mortality in COVID-19 | Serum Amyloid A as a prognostic marker for disease severity and mortality in COVID-19 | | Board of Directors Franciscus Gasthuis & Vlietland | 30/11/2020 | 20201130 | Netherlands Trial Register | https://trialregister.nl/trial/9082 | Not Recruiting | No | | | | 01/01/2021 | 350 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Nadine | Pouw | | n.pouw@franciscus.nl | 0031 10 4616091 | | Inclusion criteria: 18 jaar or older;<br>hospitalised for (suspicion of) COVID-19;<br>written informed consent for those subjects admitted to the non-ICU clinical COVID-19 ward. | Exclusion criteria: Subjects undergoing experimental interventions will be excluded. | COVID-19 | None | Difference in sensitivity of blood plasma SAA, CRP , ferritin and PCT levels on day 1, day 3, day 5 and day 7 of hospital stay in patients with severe versus non-severe COVID-19 disease course. | | | | Yes | False | | |
| → | NL9141 | 1 November 2021→15 November 2021 | Obesity and COVID-19: AdipoSe TissuE Responses to SARS-CoV-2 infection | Obesity and COVID-19: AdipoSe TissuE Responses to SARS-CoV-2 infection | | UMCG | 23/12/2020 | 20201223 | Netherlands Trial Register | https://trialregister.nl/trial/9141 | Recruiting | No | | | | 23/12/2020 | 36 | Interventional |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Jill | Moser | | j.moser@umcg.nl | 050-3610229 | | Inclusion criteria: Obese: Healthy participants, male and female aged between 18-65years old with a BMI>40.<br>Lean: Healthy participants, male and female aged between 18-65years old with a BMI<25. | Exclusion criteria: Diabetes mellitus, hypertension, metabolic syndrome, asthma, immune disease such as Crohn colitis, rheumatic disease, cancer, use of soft/hard drugs or smoking. Previous COVID-19 infection. | COVID-19 | We will collect human visceral and subcutaneous adipose tissue samples in order to investigate the adipose tissue responses to ex vivo SARS-CoV-2 infection. Small adipose tissue samples (subcutaneous and visceral) will be collected from patients undergoing either bariatric surgery (obese) or elective abdominal surgery (visceral only) (lean). | <br>Visceral and subcutaneous adipose tissue susceptibility and permissiveness to SARS-CoV-2 infection. | | | | Yes | False | | |
| → | NL8889 | 1 November 2021→15 November 2021 | Corona Onderzoek Limburg | Corona Research Limburg | | GGD South Limburg | 10/09/2020 | 20200910 | Netherlands Trial Register | https://trialregister.nl/trial/8889 | Not Recruiting | No | | | | 10/09/2020 | 10000 | Observational |
Randomized: No,
Masking: Unknown,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: Unknown, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Nicole | Dukers-Muijrers | | nicole.dukers@ggdzl.nl | +31(0)629193150 | | Inclusion criteria: 18 years and older and residence in Limburg, Nethetrlands | Exclusion criteria: younger than 18 years or no residence in Limburg | Sars-Cov-2-antibodies | No interventions; observational study | The primary outcome measure of the study is the result of SARS-CoV-2 antibody testing (positive or negative), based on total IgG (dichotomous value). | | | | Yes | False | | |
| → | NL9161 | 1 November 2021→15 November 2021 | Effect of Iodine treatment in patiënts with COVID-19 disease | Effect of Iodine treatment in patiënts with COVID-19 disease | | Maxima Medisch Centrum | 08/01/2021 | 20210108 | Netherlands Trial Register | https://trialregister.nl/trial/9161 | Not Recruiting | No | | | | 23/10/2020 | 200 | Interventional |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Rene | Traksel | | r.traksel@mmc.nl | 040-8885676 | | Inclusion criteria: Patients 18 years of age and older, admitted to a hospital and who are tested positive for SARS-CoV-2 infection, are recruited for the study. <br>Patiënts must be legally competent and able to read the patient's information letter and sign the informed consent form. | Exclusion criteria: Thyroid disease or treatment, like goiter, thyroidectomy, radioactive iodine, medication related to thyroid dysfunction or the use of Amiodaron. | COVID 19 | Once daily a quarter of a 65 mg potassiumiodine tablet during eight consecutive days | 1. Number of necessities to transfer from regular ward to IC department<br>2. Mortality rate | | | | No | False | | |
| → | NL9177 | 1 November 2021→15 November 2021 | Lessons and needs arising from experienced moral stress and moral dilemmas at the ICU during the COVID-19 pandemic | Medical ethical issues at the ICU at the time of COVID-19 | | Amsterdam UMC - Location AMC | 06/01/2021 | 20210106 | Netherlands Trial Register | https://trialregister.nl/trial/9177 | Not Recruiting | No | | | | 01/08/2020 | 200 | Observational |
Randomized: No,
Masking: Single,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: Single, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Mark | van Zuylen | | m.l.zuylenvan@amsterdamumc.nl | +31629600111 | | Inclusion criteria: All employees of medical disciplines including senior house officers, specialist registrars and medical specialists, nurses (in training) and nurse anesthesists (in training) who worked in the Intensive Care departments of the Amsterdam UMC - Location AMC at the time of the start of the first wave of the COVID-19 crisis. | Exclusion criteria: Unwillingness to fill in the anonymous questionnaire | COVID-19; moral stress | | The extensive mapping of the moral dilemmas and moral issues that employees at the Intensive Care of the Amsterdam UMC - Location AMC had to deal with during the first wave of the COVID-19 crisis. | | | | No | False | | |
| → | NL9459 | 1 November 2021→15 November 2021 | CovidTherapy@Home. Action research on development of a regionally supported, safe, feasible, and scalable intervention to monitor and optimally treat COVID-19 patients with hypoxemia and/or respiratory distress in their home setting. | Action research on development of a regionally supported, safe, feasible, and scalable intervention to monitor and optimally treat COVID-19 patients with hypoxemia and/or respiratory distress in their home setting. | | UMC Utrecht | 03/05/2021 | 20210503 | Netherlands Trial Register | https://trialregister.nl/trial/9459 | Not Recruiting | No | | | | 03/05/2021 | 30 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Karin | Smit | | k.smit-7@umcutrecht.nl | 0650177684 | | Inclusion criteria: Two categories of patients will be included:<br><br>Category 1: <br>Patients with COVID-19 and hypoxemia and/or respiratory distress without signs of clinical instability who normally would be admitted to a hospital COVID ward for treatment<br><br>Category 2:<br>Patients with (a strong suspicion of) COVID-19 and hypoxemia and/or respiratory distress in whom hospitalisation is not considered desirable, but treatment at home is considered desirable.<br><br>Additional inclusion criteria for category 1 (not 2):<br>-Positive SARS-CoV-2test (PCR or rapid antigen test)<br>-GP considers referral to hospital because of hypoxemia, defined as SpO2 <94% in rest AND/OR increased respiratory effort with respiratory rate >24/min<br>-Partner/caregiver present at the patient's home for providing supportive care<br>-Capable of using a pulse oximeter<br>-Age 18 years or older<br>-Mentally competent<br>-Sufficient proficiency of the Dutch language to provde informed consent<br><br>Additional inclusion criteria for category 2 (not 1):<br>-Hypoxemia defined as SpO2 <94% in rest AND/OR increased respiratory effort with respiratory rate >24/min<br>-Partner/caregiver present at the patient's home for providing supportive care<br>-Capable of using a pulse oximeter<br>-Age 18 years or older<br>-Mentally competent<br>-Sufficient proficiency of the Dutch language to provde informed consent | Exclusion criteria: Exlusion criteria for both category patients<br>- active smoking (due to associated risks with oxygen therapy)<br>- dementia or severe psychiatric illness<br>- inadequate mastery of the Dutch language<br><br>Additional exclusion criteria for category 1 (not 2):<br>- Age 80 or older<br>- Severe clinical condition warranting intensive treatment in hospital setting or ICU admission<br>- More medical care is necessary than can be organised in the home setting<br>- Presence of one of the following co morbidities:<br>-- COPD Gold III-IV or other chronic lung disease treated by a pulmonologist<br>-- history of PE/DVT in medical<br>-- renal insufficiency defined as eGFR <30<br>--insuline dependent DM or poorly managed DM<br>--heart failure<br>--immunocompromised status<br>--obesity defined as BMI>35<br>--severe liver disease Child-Pugh B or C<br>--medical condition that precludes reliable pulse oximetry measurement, e.g. Raynaud or sever anemia<br><br>Additional exclusion criteria for category 2 (not 1):<br>-severe disease or such critical clinical condition that the physician decides to start palliative care | COVID-19; SARS-COV-2 infection | | Feasibility defined as reaching a stable, regionally supported intervention to monitor and optimally treat patients with COVID-19 at home with the use of short-cylce evaluation roundes. We will use data of 30 patients. <br><br> | | | | Yes | False | | |
| → | NL8460 | 1 November 2021→15 November 2021 | Biomarkers for prognosis in critically ill COVID-19 patients : a prospective cohort study | Biomarkers for prognosis in critically ill COVID-19 patients : a prospective cohort study | | none | 16/03/2020 | 20200316 | Netherlands Trial Register | https://trialregister.nl/trial/8460 | Recruiting | No | | | | 16/03/2020 | 100 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | JAH | VAN Oers | | jah.vanoers@etz.nl | 0132213808 | | Inclusion criteria: SARS-CoV 2 PCR positive patients at the intensive care | Exclusion criteria: SARS-CoV 2 PCR negative OR no SARS-CoV 2 PCR | Lower respiratory tract infections | During routine daily laboratory rounds blood will be stored at -80 C until biomarkers will be assayed later. | 28-day mortality | | | | Yes | False | | |
| → | NL9214 | 1 November 2021→15 November 2021 | SARS-CoV-2 vaccination response in people living with HIV | SARS-CoV-2 vaccination response in people living with HIV | | OLVG, LUMC, Erasmus MC | 20/01/2021 | 20210120 | Netherlands Trial Register | https://trialregister.nl/trial/9214 | Not Recruiting | No | | | | 20/01/2021 | 1000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Anna | Roukens | | a.h.e.roukens@lumc.nl | +31715262613 | | Inclusion criteria: 18 years or older, confirmed HIV-infection, selected by national regulations for SARS-CoV-2 vaccination | Exclusion criteria: none | COVID-19, HIV | Blood sampling before the first and after the second SARS-CoV-2 vaccination (vaccinations are performed by the family doctor of municipal health center) | To determine the humoral vaccine efficacy against SARS-CoV-2 in PLWHIV 2 weeks after the completed vaccination schedule (all participants) | | | | Yes | False | | |
| → | NL8483 | 1 November 2021→15 November 2021 | A weapon against COVID-19: (Social) media and influencers | The use of (social) media | | Fred Foundation ; Noaber Foundation | 26/03/2020 | 20200326 | Netherlands Trial Register | https://trialregister.nl/trial/8483 | Recruiting | No | | | | 16/03/2020 | 17000 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Hamza | Yousuf | | hamza@hamzayousuf.nl | 00 31 20 444 22 44 | | Inclusion criteria: Able to fill in the questionnaire in Dutch | Exclusion criteria: Younger than 8 years old | SARS-CoV-2 | Infotainment intervention with (social) media and influencers. | Elevation of proper hygiene behaviour (behavioural change) | | | | No | False | | |
| → | NL8485 | 1 November 2021→15 November 2021 | COVID-19 during pregnancy: a prospective observational cohort | COVID-19 during pregnancy: a prospective observational cohort | | Máxima MC | 27/03/2020 | 20200327 | Netherlands Trial Register | https://trialregister.nl/trial/8485 | Not Recruiting | No | | | | 27/03/2020 | 20 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Marion | Frenken | | marion.frenken@mmc.nl | 040-8888380 | | Inclusion criteria: Pregnant women who tested positive on SARS-CoV-2, regardless of the presence or absence of any clinical symptoms | Exclusion criteria: Women <18 years old | COVID-19 during pregnancy | None | -To describe the clinical presentation (symptoms) of pregnant women who tested positive on SARS-CoV-2<br>-To describe the clinical course of COVID-19 infection during pregnancy | | | | Yes | False | | |
| → | NL8491 | 1 November 2021→15 November 2021 | Countering Lung Damage in COVID-19 infection (CounterCovid) study | Countering Lung Damage in COVID-19 infection (CounterCovid) study | | Amsterdam UMC | 31/03/2020 | 20200331 | Netherlands Trial Register | https://trialregister.nl/trial/8491 | Recruiting | No | | | | 31/03/2020 | 386 | Interventional |
Randomized: No,
Masking: Double,
Control: Placebo,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Double, <br> Control: Placebo, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Harm Jan | Bogaard | | hj.bogaard@amsterdamumc.nl | +31020 444 1896 | | Inclusion criteria: - Age >18 years<br>- Hospital admission with proven SARS2-Covid19 infection<br>- Hypoxemic respiratory failure (SaO2 <92%, PaO2 <8kPa)<br>- Ability to give informed consent | Exclusion criteria: 1. Pre-existing chronic pulmonary disease, including:<br>? Known diagnosis of Interstitial Lung disease<br>? Former diagnosis of COPD 4 or FEV1<30%pred<br>? DLCO <45%<br>? Total lung capacity (TLC) < 60% of predicted<br>? Lung cancer with non-surgical treatment in last year<br>2. Home oxygen treatment<br>3. Pre-existing heart failure with a known left ventricular ejection fraction <40%<br>4. Active treatment of hematological or non-hematological cancer with targeted, immuno- or chemotherapy in the last year<br>4. Inability to provide informed consent<br>5. Any subject who had received any investigational medication within 1 month prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study<br>6. Active liver disease, porphyria or elevations of serums transaminases >3 x ULN (upper limit of normal) or bilirubin > 1.5 x ULN<br>7. History or suspicion of inability to cooperate adequately.<br>8. White blood count < 4.0^109/l<br>9. Hemoglobin < 6.0 mmol/l<br>10. Thrombocytes < 100^109/l<br>11. Pregnant female subjects<br>12. Breastfeeding female subjects | Covid19 positive pneumonitis with need for hospital admission | Imatinib or placebo | time to liberation from ventilation and supplemental oxygen and alive during a 28day period after randomization | | | | Yes | False | | |
| → | NL9211 | 1 November 2021→15 November 2021 | Studying coagulation specific for COVID-19 using "Blood-vessel-on-chip" technology. | Studying coagulation specific for COVID-19 using "Blood-vessel-on-chip" technology. | | ZonMw | 11/01/2021 | 20210111 | Netherlands Trial Register | https://trialregister.nl/trial/9211 | Recruiting | No | | | | 17/01/2021 | 24 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Thijs | van Haaps | | t.f.vanhaaps@amsterdamumc.nl | 020-5669111 | | Inclusion criteria: - Age of 18 years or older<br>- A suspected SARS-CoV-2 virus infection<br>- Need for oxygen supplementation<br>- CRP level > 50 mg/L<br>- D-dimer level > 0.5 mg/L<br>- Ability to provide written informed consent | Exclusion criteria: - History of venous thromboembolism<br>- Use of anticoagulant therapy at inclusion<br>- Known hereditary or acquired thrombophilia | COVID-19 | Blood taking procedure (total amount of 22.1 mL blood) | Percentage of endothelial surface in the blood-vessel-on-chip model that is covered by platelets and fibirn ("clotting") upon treatment with COVID-19 patient plasma. Coverage in the blood-vessel-on-chip will be measured by fluorescence microscopy. | | | | Yes | False | | |
| → | NL9238 | 1 November 2021→15 November 2021 | Long term smell and taste alterations in COVID-19 patients. | Long term smell and taste alterations in COVID-19 patients. | | UMCG | 25/01/2021 | 20210125 | Netherlands Trial Register | https://trialregister.nl/trial/9238 | Recruiting | No | | | | 30/10/2020 | 150 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | Jacco | de Haan | | j.j.de.haan@umcg.nl | 050-361 28 21 | | Inclusion criteria: <br>- = 18 years<br>- Six to nine months after confirmed COVID-19 <br>- Able to understand spoken and written Dutch<br>- Able to comprehend and complete questionnaire<br> | Exclusion criteria: <br>- Use of drugs affecting taste or smell function | COVID-19 | on-line questionnaire | Impact of smell and taste alterations on ADL and QoL six to nine months after diagnosis of COVID-19 | | | | No | False | | |
| → | NL9485 | 1 November 2021→15 November 2021 | Online guided vs. unguided cognitive behavioral therapy for distress in people who lost a loved one during the COVID-19 pandemic: A controlled trial | The effectiveness of an online cognitive behavioral therapy for people who lost loved ones during the COVID-19 pandemic: A controlled trial | | Utrecht University | 18/05/2021 | 20210518 | Netherlands Trial Register | https://trialregister.nl/trial/9485 | Recruiting | No | | | | 01/03/2021 | 102 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Lyanne | Reitsma | | l.reitsma@uu.nl | 06-22299573 | | Inclusion criteria: Inclusion criteria for participation in the study are as follows: 1) having lost a loved one (i.e., a family member, spouse or friend), 2) the death occurred at least three months earlier during the COVID-19 pandemic (period March 2020 until present), 3) at least 18 years of age and 4) report clinically relevant symptoms of PCBD, PTSD, and/or depression based on clinical telephone interviews. | Exclusion criteria: Exclusion criteria are the following: 1) no mastery of the Dutch language, 2) no Internet access and/or 3) suffering from a psychotic disorder or suicidality. | Persistent Complex Bereavement Disorder, Posttraumatic Stress Disorder, depression. | The investigational treatment consists of a guided online grief-specific CBT aimed at people who report clinically relevant levels of PCBD, PTSD and/or depression, at least three months after the loss of (a) loved one(s) during the COVID-19 pandemic. Therefore, this treatment could be viewed as a secondary preventive treatment and not a primary preventive treatment (which includes self-help modules accessible for all bereaved people; Schut & Stroebe, 2005). The guided online CBT consists of eight weekly sessions tailored to this specific population. During treatment, participants will be supported by a trained psychologist through e-mail contact. According to the Dutch guidelines for the treatment of PCBD, central components of the online treatment are exposure, cognitive restructuring, and behavioral activation (Boelen & van den Bout, 2017). Session 1 consists of psychoeducation regarding possible emotional reactions to the loss of (a) loved one(s) during the COVID-19 pandemic that might facilitate or hamper recovery from the loss. In addition, information is offered about specific corona-related factors that could exacerbate grief symptoms in this specific population, such as the impact of the absence of traditional grief rituals, lack of physical social support, and fear of infection with COVID-19. Lastly, a rationale of the CBT treatment is offered. Session 2, 3 and 4 consist of exposure exercises; the circumstances and story of the loss are addressed in detail, and the participant is encouraged to face stimuli that are avoided. Further, a rationale of exposure is provided using examples of avoidance of stimuli relevant for this population (e.g. the hospital where the loved one passed). Session 5 and 6 are focused on cognitive restructuring; these sessions are aimed | PCBD symptoms will be assessed with the Traumatic Grief Inventory – Clinician-Administered (Lenferink et al., in prep.). | | | | No | False | | |
| → | NL9247 | 1 November 2021→15 November 2021 | Clinical validation of lung ultrasound for the diagnosis of COVID-19 | Clinical validation of lung ultrasound for the diagnosis of COVID-19 | | NA | 04/02/2021 | 20210204 | Netherlands Trial Register | https://trialregister.nl/trial/9247 | Recruiting | No | | | | 01/02/2021 | 150 | Observational |
Randomized: No,
Masking: Unknown,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: Unknown, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Ronald | Henry | | rma.henry@mumc.nl | 043-3871562 | | Inclusion criteria: - patients who enter the emergency department<br>- 18 years of age or older<br>- capacitated (able to make a reasonable judgement of their own interests with regards to the study)<br>- with (newly developed) symptoms of COVID-19 (fever or chills, cough, shortness of breath or difficulty breathing, new loss of taste or smell, sore throat, congestion or runny nose)<br>- signed informed consent | Exclusion criteria: - pregnancy<br>- contra-indications for ultrasound | COVID19 | Lung ultrasound | Lung ultrasound sensitivity to predict COVID-19 diagnosis | | | | No | False | | |
| → | NL9250 | 1 November 2021→15 November 2021 | Detection COVID-19 from exhaled air analysed with Aeonose™ | Detection COVID-19 from exhaled air analysed with Aeonose™ | | eNose | 21/12/2020 | 20201221 | Netherlands Trial Register | https://trialregister.nl/trial/9250 | Recruiting | No | | | | 26/11/2020 | 3000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | M | Fokkert | | m.j.fokkert@isala.nl | 0384244394 | | Inclusion criteria: • Subjects with a suspicion COVID-19 infection. <br>• All subjects must be older than 18 years and not mentally handicapped. <br> | Exclusion criteria: •subjects with dyspnea and/or use supplemental oxygen | COVID-19 | | Is it possible to detect persons with a COVID-19 infection from exhaled air analysed with the Aeonose™? | | | | No | False | | |
| → | NL8497 | 1 November 2021→15 November 2021 | Lung ultrasound vs CT scan in COVID-19 disease | A prospective observational multi-center trial assessingthe diagnostic value of lungultrasound (LUS) vs CT-scan in patientswith COVID-19Infection | | Radboudumc | 31/03/2020 | 20200331 | Netherlands Trial Register | https://trialregister.nl/trial/8497 | Recruiting | No | | | | 15/03/2020 | 200 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Frank | Bosch | | frank.bosch@radboudumc.nl | +31243619880 | | Inclusion criteria: -Age (=18 years)-<br>Proven(PCR) or suspected (based on clinical signs) COVID-19 infection-<br>Referralor admission for internal, emergency or respiratory medicine-<br>Certified sonographerpresent | Exclusion criteria: <br>Absence of COVID infection | SARS-CoV2 Infection | Lung Ultrasound and CT-scan | Diagnostic accuracyof LUSand CT in COVID-19 patients | | | | No | False | | |
| → | NL8900 | 1 November 2021→15 November 2021 | T2B! immunity after SARS-CoV-2 | Immunity against SARS-CoV-2 in immune-suppressed patients: increased risk of insufficient immunological memory or sufficient protection against re- infection – a Target to B! substudy | | ZonMw | 09/09/2020 | 20200909 | Netherlands Trial Register | https://trialregister.nl/trial/8900 | Recruiting | No | | | | 09/09/2020 | 5000 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Luuk | Wieske | | l.wieske@amsterdamumc.nl | 020-7328660 | | Inclusion criteria: Patients with auto-immune disorders with or without immunosuppressive medication or healthy controls, above 18 years | Exclusion criteria: Known pregnancy during study entry. Concomitant treatment with immunosuppressive medication (like chemotherapy) for cancer or organ-transplantation (including stem-cell transplantation). | SARS-CoV-2, auto-immune diseases, | | - Effects of systemic immunosuppressive medication on the serologic response at 28-days after the last SARS-CoV-2 vaccination<br>- Difference in SARS-CoV-2-specific B- and T-cell frequencies and functional phenotype and determinants thereof | | | | Yes | False | | |
| → | NL8498 | 1 November 2021→15 November 2021 | Lung ultrasound (LUS) as a tool to determine the clinical course in COVID-19 patients | Lung ultrasound (LUS) as a tool to determine the clinical course in COVID-19 patients | | Radboudumc | 31/03/2020 | 20200331 | Netherlands Trial Register | https://trialregister.nl/trial/8498 | Recruiting | No | | | | 15/03/2020 | 20 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Frank | Bosch | | frank.bosch@radboudumc.nl | +31243619880 | | Inclusion criteria: Age (=18 years)<br>Proven(PCR) or suspected (based on clinical signs and imaging) COVID-19 infection-<br>Referral or admission for internal, emergency or respiratory medicine-<br>Certified sonographerpresent | Exclusion criteria: -Pre-existing pulmonary disease or heart failure<br>-Absence of COVID infection | SARS-CoV2 infection | Lung Ultrasound | Patients will receive regular care as indicated by the treating physician. LUS is performed immediately in the Emergency Department or after admissionto the hospital. SARS-CoV-2 PCR testing will be performed along with standard laboratory testing and other microbiological tests to detect pathogens that cause respiratory tract infection.CT-scan during admission is only performed if this is clinically indicated or protocol during COVID outbreak. | | | | No | False | | |
| → | NL8504 | 1 November 2021→15 November 2021 | Pre-emptive tocilizumab in hypoxic COVID-19 patients, a prospective randomized trial | Pre-emptive tocilizumab in hypoxic COVID-19 patients, a prospective randomized trial | | UMCG, Roche | 03/04/2020 | 20200403 | Netherlands Trial Register | https://trialregister.nl/trial/8504 | Not Recruiting | No | | | | 06/04/2020 | 354 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Margriet | Dijkstra | | m.j.dijkstra-tiekstra@umcg.nl | +31 50 3610468 | | Inclusion criteria: ? Patients 18 years and older<br>? Patients with a diagnosis of COVID-19 based on a compatible clinical presentation AND a positive SARS-CoV-2 PCR on a respiratory sample such as a nasopharyngeal swab, sputum, or BAL fluid<br>? Clinical features compatible with hyperinflammation:<br>- Hypoxia, without other explanation for hypoxia than COVID-19 OR<br>- ferritin >2000 µg/L or doubling of serum ferritin in 20-48 hours<br>Hypoxia is defined according to ASTCT CRS Consensus grading: grade II. [Lee DW, et al. BBMT 2019;25(4):625-638] Inclusion of patients already requiring oxygen administration prior to COVID-19 should be discussed with the study team.<br>? Written informed consent.<br>? Patient is capable of giving informed consent. | Exclusion criteria: ? Pregnancy<br>? allergy to tocilizumab | COVID-19 with Hypoxia | Patients in this study are treated with intravenous tociluzumab: 8 mg/kg (maximum dose 800 mg), which can be repeated at the same dose after 8 hours if the hypoxia has not improved. This is the approved dose for cytokine release syndrome. | 30-day mortality (from randomization) | | | | Yes | False | | |
| → | NL9538 | 1 November 2021→15 November 2021 | Investigating the immune response to COVID-19 vaccination in lung transplantation patients (COVALENT study) | Investigating the immune response to COVID-19 vaccination in lung transplantation patients (COVALENT study) | | University Medical Center Groningen (UMCG) | 15/06/2021 | 20210615 | Netherlands Trial Register | https://trialregister.nl/trial/9538 | Not Recruiting | No | | | | 22/02/2021 | 180 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Single arm
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Single arm<br> | | The Netherlands | H.T.G.M. (Thea) | Scholtens | | h.t.g.m.scholtens@umcg.nl | 0652724271 | | Inclusion criteria: ? All patients should be eligible for COVID-19 vaccination as described by the instructions of the manufacturer.<br>? Provision of written informed consent<br>? =18 years of age<br>? Belong to one of the four populations as named in 4.1. | Exclusion criteria: ? Contra-indications for vaccination (unrelated to the study)<br> -History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (e.g., anaphylaxis) to any component of the study intervention(s).<br> -Pregnancy at the time of the vaccinations<br>? Exclusion specific to this investigation<br> -No administration of SARS-CoV-2 vaccine due to any reason<br> -Active (hematological) malignancy<br> -Inherited immune deficiency<br> -Receiving anti-retroviral medication o Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.<br> -Waitlist patients with a passed COVID-19 infection.<br> -Transplantation candidates who do not receive a transplantation within 15 months after receiving the second vaccination dose will remain included as controls. However, sampling will not continue after long<br> transplantation if the transplant occurs at a later time. | End stage lung disease | SARS-CoV-2 vaccine (not study related), blood samples | To determine the antibody response of lung transplantation recipients and patients who are on the waiting list for lung transplantation, to the SARS-CoV-2 vaccine at 28 days, 6 months and 12 months after the second vaccine dose, compared to the immune response of healthy individuals. Healthy individuals are part of the RECOVAC study (METC approved on 23rd December 2020). | | | | No | False | | |
| → | NL9547 | 1 November 2021→15 November 2021 | Prospective monitoring of immune response following COVID-19 vaccination in children with cancer | Prospective monitoring of immune response following COVID-19 vaccination in children with cancer | | Princess Máxima Center for Pediatric Oncology | 15/06/2021 | 20210615 | Netherlands Trial Register | https://trialregister.nl/trial/9547 | Recruiting | No | | | | 05/07/2021 | 130 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Jaap | Mur | | J.Mur@prinsesmaximacentrum.nl | 06-5000 6646 | | Inclusion criteria: Children with cancer, treated with chemotherapy and/or immunotherapy in the last 4 years<br>Willing to receive routine COVID-19 vaccinations as part of national vaccination program<br>Informed consent | Exclusion criteria: History of severe adverse reaction associated with a vaccine and/or severe allergic reaction to any component of the study intervention<br>Not able to give informed consent | Pediatric cancer | Blood sampling at 4 timepoints, vaccination against COVID-19 as part of national vaccination program. | Antibody based immune response to vaccination againtst COVID-19 28 days (t=3) after the second vaccination as compared to controls. | | | | Yes | False | | |
| → | NL9553 | 1 November 2021→15 November 2021 | COVID-19 vaccination in patients with reduced B-cell and T-cell immunity: response after vaccination of a kaleidoscopic group hematological patients, what’s the impact? | COVID-19 vaccination in patients with reduced B-cell and T-cell immunity: response after vaccination of a kaleidoscopic group hematological patients, what’s the impact? | | AUMC location VUmc | 07/06/2021 | 20210607 | Netherlands Trial Register | https://trialregister.nl/trial/9553 | Not Recruiting | No | | | | 01/03/2021 | 850 | Interventional |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Edith | van Dijkman | | hemat.metc@amsterdamumc.nl | +31641360674 | | Inclusion criteria: Age =16 years<br>- The following patient cohorts will be included: Acute lymphoblastic leukemia (ALL), B-cell non Hodgkin lymphoma, multiple myeloma, chronic lymphocytic leukemia (CLL), acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), myeloproliferative diseases (MPN), patients with hemoglobinopathies (sickle cell disease and thalassemia), patients who received cell therapy (autologous HCT, allogeneic HCT or CAR T-cell therapy) AND<br>- Patients must either currently receive immuno-chemotherapy or have received such therapy in the past 12 months, or currently receive targeted agents, or have received autologous or allogeneic stem cell transplantation no longer than 12 months prior, or have received CART therapy. | Exclusion criteria: Unwilling or unable to give informed consent<br>- Known allergy to one of the components of the vaccine<br>- Patients with a life expectancy of < 12 months<br>- Of note: although we will investigate serologic evidence of prior infection with SARS-CoV-2 in all participants, seropositivity is not an exclusion criterion. The main reasons for this are first that we expect seroprevalence to be well below 5%, because of the stringent isolation measures that are already in place in this patient population; second, a test-first-strategy for seroprevalence would seriously hamper the speed of vaccination rollout, whereas vaccination of seropositive patients is indicated nonetheless, according to the national vaccination guidelines | Hematological Diseases | All participants will be invited for blood sampling prior to vaccination. They will return for blood sampling prior to the 2nd vaccination and 4 weeks after completion of the COVID-19 vaccinationschedule. Since all patients are under current treatment or close follow-up, sampling at 6 and 12 months can be coupled to regular visits and blood sampling. Participants will be instructed to contact their vaccination site for any SAE within 7 days following each vaccination. | To identify subcategories of hematology patients with A) sufficient protection against COVID-19, +28 days after completion of the standard COVID-19 vaccination schedule (responders: seroconversion), B) insufficient protection, who may benefit from boostervaccinations (low-responders: antibody response but no seroconversion) and C) insufficient protection (non-responders: no seroconversion, no antibody response). | | | | No | False | | |
| → | NL9554 | 1 November 2021→15 November 2021 | REturn-to-work And DisAbility Pension afTer COVID-19 virus pandemic. A prospective study | RE-ADAPT-post-COVID-19-study | | This study is a collaboration between Zuyderland Medical Center and the Employee Insurance Agency (UWV). | 08/06/2021 | 20210608 | Netherlands Trial Register | https://trialregister.nl/trial/9554 | Recruiting | No | | | | 01/07/2021 | 2000 | Observational |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Martijn | Schotanus | | m.schotanus@zuyderland.nl | 06-52377871 | | Inclusion criteria: - pre-covid employment<br>- ’vaste aanstelling’<br>- confirmed COVID-diagnosis<br>- admitted to the hospital due to COVID-19:<br> - medium-, and/or intensive-care | Exclusion criteria: - age <18 and > 66 years of age | COVID-19 disease | return-to-work and (partial) disability pension | - What is the nation-wide incidence of patients on a disability pension (and/or partial disability pension) and return to the original job (conform pre- COVID-19 disease situation) after COVID-19?<br>- Does incidence of being granted a disability pension (and/or partial disability pension) or return to work after COVID-19 differ by per region socio-economic status (SES)? | | | | Yes | False | | |
| → | NL8562 | 1 November 2021→15 November 2021 | Bioelectric Impedance Analysis in COVID-19 positive patients. A prospective prevalence study | Bioelectric Impedance Analysis in COVID-19 positive patients. A prospective prevalence study | | None (investigator initiated study) | 21/04/2020 | 20200421 | Netherlands Trial Register | https://trialregister.nl/trial/8562 | Not Recruiting | No | | | | 01/04/2020 | 150 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Hanneke | Moonen | | moonenh@zgv.nl | 0318434119 | | Inclusion criteria: 1. Age = 18 years<br>2. SARS-CoV-2 positive (PCR or radiological diagnosis)<br>3. Informed consent by patient / or legal representative | Exclusion criteria: 1. Pregnant patients. <br>2. Patients with electrical implants such as a pacemaker or ICD. <br>3. Patients who cannot maintain posture for the (10-15 min) duration of the measurement.<br> | SARS-CoV-2 | | To measure body composition and specifically fat percentage and localisation in SARS-CoV-2 positive patients | | | | No | False | | |
| → | NL9067 | 1 November 2021→15 November 2021 | High-Flow Nasal Cannula for severe COVID-19, a multicentre prospective cohort study | High-Flow Nasal Cannula for severe COVID-19, a multicentre prospective cohort study | | No sponsors | 27/11/2020 | 20201127 | Netherlands Trial Register | https://trialregister.nl/trial/9067 | Not Recruiting | No | | | | 01/12/2020 | 600 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Yasemin | Türk | | y.turk@franciscus.nl | 0104616161 | | Inclusion criteria: The population included will be hospitalized patients with confirmed COVID-19, = 18 years old with isolated severe hypoxic respiratory failure defined as: SpO2 < 92% and/or BF>30/min despite treatment with at least 6 L/min oxygen therapy on nasal cannula. These patients may be included at the pulmonary departments delivering COVID-19 care, intensive care units or directly on the Emergency department. SARS-CoV-2 negative patients (nasopharyngeal PCR) will be excluded for this analysis, retrospectively.<br><br>Inclusion criteria<br>In order to be eligible to participate in this study, a subject must meet all of the following inclusion criteria:<br>? Age = 18 years<br>? Admitted to the hospital<br>? Suspect of COVID-19 or nasopharyngeal swab PCR confirmed COVID-19<br>? SpO2 < 92% and/ or breathing frequency >30/min despite at least 6L O2/min on nasal cannula. | Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:<br>? Reasons for direct intubation, as per local standard of clinical care.<br>? Patient does not accept treatment with HFNC<br>? Anatomic abnormalities (recent surgery of the face, nose, or airway) that preclude an appropriate-fitting nasal cannula | COVID-19 | HFNC treatment on the appointed general wards, the emergency department or on the ICU. Patients will be treated according to the current local guidelines of the hospital, within their standard of care.<br><br>The indications for start of HFNC is:<br>Despite the need of at least 6L O2/min:<br>1. SpO2 < 92%<br>and/or<br>2. Breathing frequency >30/min<br><br>HFNC can be adapted on basis of oxygen saturation and respiratory rate, aiming for an adequate oxygen saturation and respiratory rate, for which the target values may vary between different centres.<br>Minimal requirement for monitoring will consist of O2 saturation, respiratory rate, ROX-index (see below), blood pressure, HR at regular time points after initiation of HFNC and at least at time-points 0, 0/5, 1, 2, 4, 6, 12, 24h after start of HFNC and 3 times daily thereafter. After discontinuation of HFNC these parameters will be monitored at least 3 times daily and on clinical indication.<br>Arterial blood gas analysis will be performed at the discretion of the treating physician, but preferably at hospital admission, just before start of HFNC and on indication, for example when there is a clinical deterioration and/or suspected hypercapnia.<br><br>ROX index = %SpO2/(FiO2*breathing frequency)<br>• SpO2% (0-100%)<br>• FiO2: 0.21-1.0<br>• Breathing frequency (0-…/min)<br><br>The FiO2 on conventional oxygen therapy will be estimated as follows: FiO2(%) = 21 + 4 * flow (L/min) [12]. The FiO2 when using HFNC is the set FiO2.<br>The intensive care department may be informed before the start of HFNC on the ER/wards and consultation of the intensive care department is advised in the following conditions:<br><br>Major criteria<br>Following conditions during treatment with HFNC, despite FiO2 0.6 (=60%)<br>? SpO2 <92%<br>or<br>? ROX index = 4.88<br>or<br>? Worsening of ROX index after start of HFNC<br>or<br>? | The primary study endpoint is HFNC failure.<br><br>HFNC failure is defined as:<br>? Patients without a DNI policy: Intubation.<br>or<br>? Patients with DNI policy: Persistent hypoxemia, defined as SpO2 < 90% despite a maximum FiO2 (>90%) and flow (>50L/min) and/or death because of terminal respiratory failure. | | | | Yes | False | | |
| → | NL9220 | 1 November 2021→15 November 2021 | Virtual reality for relatives of ICU patients (ICU-VR-F) to improve psychological sequelae. | Virtual reality for relatives of ICU patients (ICU-VR-F) to improve psychological sequelae; a multicenter, randomized controlled trial. | | Erasmus Medical Center, Rotterdam, the Netherlands | 25/01/2021 | 20210125 | Netherlands Trial Register | https://trialregister.nl/trial/9220 | Recruiting | No | | | | 25/01/2021 | 160 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Johan | Vlake | | j.vlake@erasmusmc.nl | +31641545743 | | Inclusion criteria: • =18 years old<br>• First/second degree relatives (spouses, sibling, parent, children), responsible for decision making, sharing the same household (in absence of next of kin), or close friend (in absence of other relatives)<br>• Able to understand the Dutch language<br>• In possession of a smartphone/tablet compatible to watch ICU-VR-F at home<br>• Signed informed-consent | Exclusion criteria: • Lack of a formal home address<br>• Family members of patients with an ICU-LOS <72 hours<br>• Relatives of patients who decease during ICU treatment will retrospectively be excluded from the main analysis | Post-Intensive Care Syndrome Family (PICS-F), post-traumatic stress disorder, anxiety, depression | The ICU-VR-F module was adapted to a prior designed patient VR module to match the need of relatives. The current VR module was designed with the aim to show relatives relevant and truthful information regarding their ICU treatment. The point of view for the camera was the field of vision of the mock patient lying in a hospital bed. Based on focus group meetings and previous studies, the following information was included in the module: 1) an introduction by an intensivist and an ICU nurse to welcome the patient to the ICU and VR environment explaining daily movements at an ICU, 2) explanation of monitors and noises in an ICU room, 3) information regarding mechanical ventilation, intubation and tracheal tube suction, 4) necessity of central/peripheral lines and IV/drips, 5) information and necessity of the treatment team and ICU workflow. <br>After randomization, participants in the intervention group will receive ICU-VR using head-mounted display VR (Oculus Go, Irvine, CA, CE: R-CMM-OC8-MH-A), followed by the possibility to watch the ICU-VR-F module again whenever desirable via cardboard VR glasses through an access link. The number of sessions via the cardboard VR glasses will be noted. Participants who are not allowed to visit the hospital due to COVID-19 regulations, i.e., mandatory self-quarantine, inability to visit the ICU, or a limited number of visitors, will only receive ICU-VR-R using cardboard VR glasses. | The primary endpoint is the effect of ICU-VR-F on PTSD, anxiety, depression, and quality of life in relatives of ICU patients up to six months after ICU discharge. PTSD will be assessed using the impact of event scale-revised (IES-R), anxiety and depression using the hospital anxiety and depression scale (HADS), and quality of life using the RAND-36. | | | | Yes | False | | |
| → | NL8835 | 1 November 2021→15 November 2021 | Intensive Care Unit specific Virtual Reality (ICU-VR) to improve psychological impairments in survivors of COVID-19; a multicentre, randomised controlled trial. | Intensive Care Unit specific Virtual Reality (ICU-VR) to improve psychological impairments in survivors of COVID-19; a multicentre, randomised controlled trial. | | Erasmus Medical Center | 14/08/2020 | 20200814 | Netherlands Trial Register | https://trialregister.nl/trial/8835 | Not Recruiting | No | | | | 29/06/2020 | 80 | Interventional |
Randomized: No,
Masking: None,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Johan | Vlake | | j.vlake@erasmusmc.nl | +31641545743 | | Inclusion criteria: - Above 18 years old<br>- A positive SARS-CoV-2 PCR with clinical signs of COVID-19 necessitating ICU care<br>- Able to understand the Dutch language<br>- Signed informed-consent | Exclusion criteria: - Documented active, established psychiatric disease (for instance personality disorders or schizophrenia)<br>- Admitted with or a history of primary neurological impairment necessitating ICU admission to or discharge of the ICU (patients admitted with traumatic brain injury, CVA, stroke, meningitis). Patients with a medical history of delirium are eligible, if symptoms of delirium are not present at the time of inclusion.<br>- Lack of formal home address | COVID-19, anxiety, depression, post-traumatic stress disorder (PTSD) | Intensive Care Unit Specific Virtual Reality:<br>An interdisciplinary team of three intensivists, a psychologist, a psychiatrist, two ICU nurses, a post-ICU patients, a VR/film director and a researcher designed the Intensive Care specific Virtual Reality (ICU-VR) module based on previous studies. The content available for other VR exposure therapy-based treatments are often based on or preselected out of standardized material. For different illnesses, specific VR content must be developed to improve response and specific traumatic experiences or fears. For the COVID-19 patients we therefore developed a specific COVID-19 module. Real ICU nurses and ICU physicians were used to re-enact a typical day/treatment for a mock patients undergoing COVID related ICU treatment. The module will be watched via HMD-VR glasses (Oculus Go, Irvine, CA, CE: R-CMM-OC8-MH-A). Participants will be allowed to move their head freely so that they can experience all aspects of the virtual environment.<br>This way of ICU-VR is safe and feasible, as determined in previous research, and has been already approved for use in sepsis patients in our hospital (https://www.trialregister.nl/trial/6611). The only difference of the concurrent module is that this will be a COVID-19 specific ICU-VR module (with extra explanation about COVID-19, prone position and isolation measures). | The effect of ICU-VR, given 3 months after hospital discharge, on the severity and prevalence of psychological sequelae, such as PTSD, anxiety and depression, and the health-related quality of life in ICU patients treated for COVID-19 up to 6 months after discharge, assessed using a between-group analysis. | | | | No | False | | |
| → | NL9630 | 1 November 2021→15 November 2021 | RESPOND: Improving mental healthcare for labour migrants in the Netherlands during the COVID-19 pandemic | Implementation of a stepped care program (DWM/PM+) | | Vrije Universiteit Amsterdam | 20/07/2021 | 20210720 | Netherlands Trial Register | https://trialregister.nl/trial/9630 | Not Recruiting | No | | | | 01/09/2021 | 212 | Interventional |
Randomized: No,
Masking: Single,
Control: Active,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Single, <br> Control: Active, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Rinske | Roos | | r.roos@vu.nl | +31 20 598 58 48 | | Inclusion criteria: - 18 years or older<br>- Living in the Netherlands as labour migrant<br>- Having elevated levels of psychological distress (Kessler Psychological Distress Scale (K10) >15.9).<br>- Sufficient mastery (written and spoken) of one of the languages the DWM/PM+ intervention is being delivered in (e.g. Polish, English). | Exclusion criteria: - Planning to permanently move back to their home country before the last quantitative assessment at 2 months after PM+<br>- Having acute medical conditions (requiring hospitalisation)<br>- Imminent suicide risk, or expressed acute needs or protection risks that require immediate follow-up <br>- Having a severe mental disorder (e.g. psychotic disorders, substance-dependence)<br>- Having severe cognitive impairment (e.g. severe intellectual disability or dementia)<br>- Currently receiving specialised psychological treatment (e.g. EMDR, CBT)<br>- In case of current psychotropic medication use: being on an unstable dose for at least 2 months or a change in dosage over the past 2 months. | Common mental disorders;
Depression;
Anxiety;
Posttraumatic stress disorder | The study has two arms: <br>1. Control group: participants receive care-as-usual (CAU) and Psychological First Aid (PFA).<br>2. Treatment group: participants receive care-as-usual (CAU), Psychological First Aid (PFA), and a stepped care intervention consisting of Doing What Matters in times of stress (DWM) (step 1) and conditionally, if participants still meet criteria for psychological distress (K10 >15.9) 2 weeks after having received DWM, Problem Management Plus (PM+).<br>PFA is given at the start of the RCT, which means that participants in the treatment group receive it before the start of the stepped-care DWM/PM+ intervention.<br><br>Care-as-usual (CAU):<br>All participants are allowed to receive any care-as-usual. CAU ranges from community care to specialized psychological treatments, but only care provided by the general practitioner or the assistant of the general practitioner with a specialization in mental health care (POH-GGZ) is fully covered by the basic health insurance package; it does not completely cover mental health service costs. Labour migrants who signed up for the basic health insurance package (which is obligated for everyone who plans to stay for more than 4 months or who needs to pay wage taxes due to work conducted in the Netherlands) have access to the health system like any other Dutch citizen with a standard insurance package.<br><br>Psychological First Aid (PFA):<br>All participants will be offered individual Psychological First Aid (PFA) through teleconferencing. PFA is a WHO developed support strategy that involves humane, supportive and practical help for individuals living in a serious humanitarian crisis. PFA does not necessarily involve a discussion of the event(s) that cause the distress but aims particularly at five basic elements that are crucial to promot | The primary outcome will be the decrease in symptoms of anxiety and depression from baseline to two-month follow-up, measured through the sum score of the Patient Health Questionnaire (PHQ-9) and General Anxiety Disorder-7 (GAD-7), i.e. the PHQ-Anxiety and Depression Score (PHQ-ADS). | | | | Yes | False | | |
| → | NL9631 | 1 November 2021→15 November 2021 | Non-invasive measurement of mitochondrial function in vivo in septic patients (a pilot study) | Non-invasive measurement of mitochondrial function in vivo in septic patients (a pilot study) | | Not applicable | 22/07/2021 | 20210722 | Netherlands Trial Register | https://trialregister.nl/trial/9631 | Not Recruiting | No | | | | 13/11/2017 | 45 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Lucia | Streng | | l.streng@erasmusmc.nl | 0615162574 | | Inclusion criteria: Intensive care patients:<br>In order to be eligible to participate in this study, a subject must meet the following criteria:<br><br>• 18-90 years of age<br>• Admission to intensive care ward within 72 hours before inclusion. <br><br> Aged and gender matched healthy controls:<br>• 18-90 years of age<br>• No relevant comorbidities (ASA I/II) <br>• Matched in age (±5 years) and gender to one of the participants in the COVID 19 group.<br> | Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study:<br>• Mentally disabled<br>• Porphyria<br>• Presence of mitochondrial disease<br><br>Healthy controls group: <br>• Presence of COVID-19//sepsis related complains or symptoms<br>• Presence of COVID-19/sepsis symptoms or complains, or a positive COVID-19 test less than one month ago <br>• COVID-19 vaccination less than two weeks ago<br> | COVID-19, sepsis | | Mitochondrial oxygen disappearance rate (ODR) | | | | No | False | | |
| → | NL9635 | 1 November 2021→15 November 2021 | COrticosteroids for COVID-19 induced loss of Smell | COrticosteroids for COVID-19 induced loss of Smell (COCOS trial) | | UMC Utrecht | 28/07/2021 | 20210728 | Netherlands Trial Register | https://trialregister.nl/trial/9635 | Not Recruiting | No | | | | 01/10/2021 | 116 | Interventional |
Randomized: No,
Masking: Double,
Control: Placebo,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Double, <br> Control: Placebo, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Digna | Kamalski | | d.m.a.kamalski@umcutrecht.nl | +31887556644 | | Inclusion criteria: • Recent COVID-19 infection (<3 months), confirmed with a positive test <br>• Persistent loss of smell after one month, objectified by TDI < 30.5 on Sniffin’ Stick test<br>• Age 18 years or older, capable of giving informed consent <br> | Exclusion criteria: • Pre-existing olfactory disorders<br>• Chronic rhinitis or rhinosinusitis (with or without nasal polyps) <br>• Pregnancy<br>• Corticosteroids (nasal, oral or intravenously) in last month<br>• Contra-indications of steroid use<br>o Insulin dependent diabetes mellitus<br>o Ulcus pepticum<br> | Loss of smell after COVID-19 infection | One group receives 40 mg of prednisolone daily for the duration of 10 days. The other group receives matching placebo treatment. All patients will perform smell training. | Primary outcome is objective olfactory function by means of Sniffin’ Sticks | | | | Yes | False | | |
| → | NL9648 | 1 November 2021→15 November 2021 | vIRus In Summer | Incidence and characteristics of Human Metapneumovirus infections circulating out of season in summertime after a third wave of the COVID-19 pandemic in The Netherlands | | Dr. E. R. Heddema, Department of microbiology Zuyderland Medisch Centrum, Heerlen | 04/08/2021 | 20210804 | Netherlands Trial Register | https://trialregister.nl/trial/9648 | Recruiting | No | | | | 04/08/2021 | 534 | Observational |
Randomized: No,
Masking: None,
Control: Not applicable,
Group: undefined,
Type: Not applicable
→<br> Randomized: No, <br> Masking: None, <br> Control: Not applicable, <br> Group: undefined, <br> Type: Not applicable<br> | | The Netherlands | Christopher | Kivit | | c.kivit@zuyderland.nl | 088 - 459 7777 | | Inclusion criteria: Patients presented at Zuyderland Medical Center with HMPV infection, as determined by nasopharyngeal swab in which the PCR was positive for HMPV. These included both children and adults. | Exclusion criteria: Absence of nasopharyngeal swab. No informed consent. | Human metapneumovirus infection | | Gain insight into likely shifts in incidence of HMPV, both in children and adults, between 2016 and 2021. | | | | Yes | False | | |
| → | NL9707 | 1 November 2021→15 November 2021 | COVID-19 selftest distribution at food banks – study 2 | COVID-19 selftest distribution at food banks – study 2 | | Dutch Ministry of Health, Welfare and Sport | 19/08/2021 | 20210819 | Netherlands Trial Register | https://trialregister.nl/trial/9707 | Not Recruiting | No | | | | 25/08/2021 | 150 | Interventional |
Randomized: No,
Masking: Single,
Control: Unknown,
Group: undefined,
Type: 2 or more arms, non-randomized
→<br> Randomized: No, <br> Masking: Single, <br> Control: Unknown, <br> Group: undefined, <br> Type: 2 or more arms, non-randomized<br> | | The Netherlands | Leonie | Venhoeven | | leonie@dbgedrag.nl | 06 341 57 593 | | Inclusion criteria: All customers visiting the participating Dutch food banks on the day of the data collection are invited to partake in the study. | Exclusion criteria: Customers who experience a Dutch language barrier are excluded from participation. | Covid-19 | A poster that involves the presentation of social norm and action planning components, shown at experimental food bank locations. | Whether customers use a self-test as prevention before their visit to the food bank location. | | | | Yes | False | | |
| → | NL9742 | 1 November 2021→15 November 2021 | Lactoferrin in the treatment of Long COVID | Lactoferrin in the treatment of Long COVID | | Stichting O&O Franciscus Gasthuis & Vlietland | 23/09/2021 | 20210923 | Netherlands Trial Register | https://trialregister.nl/trial/9742 | Not Recruiting | No | | | | 17/10/2021 | 72 | Interventional |
Randomized: No,
Masking: Double,
Control: Placebo,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: Double, <br> Control: Placebo, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Gert-Jan | Braunstahl | | g.braunstahl@franciscus.nl | 010-4617568 | | Inclusion criteria: - Persistent or newly developed long COVID symptoms at least 12 weeks post-primary SARS-CoV-2 infection<br>- Patients with a positive COVID-19 RT-PCR- or antibody test not older than 9 months<br>- Adult patients with age >18 years<br> | Exclusion criteria: - Patients admitted to the ICU (COVID-19-related)<br>- COVID-19-related cardiac or pulmonary tissue damage<br>- Acute infection or current systemic immunological disorders<br>- Oral and/or inhaled use of corticosteroids or use of other immune-modulatory medication <br>- Current psychiatric disorders<br>- Communication difficulties<br>- Pregnant or lactating women<br>- Age >70 years<br>- Patients with milk allergy or a known or suspected allergy or any contraindications to lactoferrin or microcrystalline cellulose (lactoferrin can be used by individuals with lactose intolerance)<br> | Long COVID | Lactoferrin 1800 mg/day versus Placebo | - Do fatigue symptoms diminish faster with the use of lactoferrin combined with usual care compared to usual care solely? | | | | Yes | False | | |
| → | NL9754 | 1 November 2021→15 November 2021 | High intensity interval training in patients with tetralogy of Fallot | High intensity interval training in patients with tetralogy of Fallot | | Erasmus MC | 27/09/2021 | 20210927 | Netherlands Trial Register | https://trialregister.nl/trial/9754 | Not Recruiting | No | | | | 01/10/2021 | 44 | Interventional |
Randomized: No,
Masking: None,
Control: Unknown,
Group: undefined,
Type: 2 or more arms, randomized
→<br> Randomized: No, <br> Masking: None, <br> Control: Unknown, <br> Group: undefined, <br> Type: 2 or more arms, randomized<br> | | The Netherlands | Wouter | van Genuchten | | w.vangenuchten@erasmusmc.nl | 0031 10 7040823 | | Inclusion criteria: * Surgical repair for Tetralogy of Fallot through transatrial-transpulmonary repair, below<br>the age of 2 years.<br>* Between 12 and 30 years of age<br>* Being followed in Erasmus MC, Sophia Childers hospital, Radboud UMC, Amalia<br>children’s hospital<br>* Does not comply with the “Nederlandse Norm Gezond Bewegen” | Exclusion criteria: * Inability to exercise or a contraindication for exercise such as long QT syndrome<br>* Contra indication for MRI such as a non MRI compatible pacemaker<br>* Ventricular outflow obstruction higher than 36 mmHg<br>* Developmental delay<br>* History of pulmonary valve replacement<br>* Use of beta blockers<br>* Documented cardiac arrhytmias | Tetralogy of Fallot | Trainings intervention:<br>Due to the ongoing COVID-19 pandemic we prefer an online intervention (example<br>shown at: https://pedcardio.shinyapps.io/TOFHIIT-example/), in this pandemic it is not<br>clear if/when gyms and physiotherapists will be available.One training a week<br>consists of jump roping (training 1), one training are body weight exercises (training 2)<br>and the last training is one of the choosing of the participants such as running or bike<br>riding (training 3). All trainings are approximately 30 minutes in length Training 1 and<br>2 will be monitored in a MS teams session and via heart rate monitor (HRM), training<br>3 can be done at a time of the choosing of the participant and the heart rate<br>monitoring file will be sent to the researcher. Training 1 and 3 will be done using the<br>10-20-30 HIIT protocol which has been shown to be more effective compared to<br>continues moderate intensity training. This protocol can be used in different<br>activities in short it consists of 10 seconds of high intensity followed by 20 seconds of<br>moderate intensity followed by 30 seconds of very light intensity. | Decrease in pulse wave velocity in the aorta and pulmonary artery measured by<br>MRI. | | | | Yes | False | | |